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Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6760]
POSTED ON BEHALF OF RYO KOHSAKA

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Dear Participants of the Online Forum on Synthetic Biology,

It is a great honour to welcome you all on board for this round of discussion. 

We have a challenging task ahead of us but I feel confident that we will be quite productive with this support of ICT technology, competent SCBD staffs and foremost your expertise and commitments.

Let me briefly introduce myself. I am Ryo Kohsaka, former SCBD staff and currently working as an academic staff at Kanazawa University in the field of agriculture and forestry science (also serving as visiting researcher at the UNU-IAS).  I have the honour to serve as a moderator for this round.

In this first round of discussion to support of the work of the AHTEG, participants of the Online Forum are invited to exchange views on how to address the relationship between synthetic biology and biological diversity. 

First, let us be clear about the terminology, finding common grounds for what we shall be discussing. We might not completely agree on the definitions but clarifying the scope will be constructive in finding the way forward.

Under the Convention biotechnology is defined as “...any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”.  Synthetic biology falls within the scope of this very broad definition and we were given the task here to consider how to address the relationship between synthetic biology and biological diversity from scientific point of view. 

There are several applications where synthetic biology and biological diversity may possibly intersect, such as, bioenergy, agriculture and chemical production, amongst other things. Such usages may impact biodiversity, either positively or negatively, at various levels including at the level of genes, species and ecosystems.

As such, the relationship between synthetic biology and biological diversity could be considered relevant in the context of the three main objectives of the Convention, namely:

• The conservation of biological diversity
• The sustainable use of the components of biological diversity
• The fair and equitable sharing of the benefits arising out of the utilization of genetic resources

In sharing your views on how to address the relationship between synthetic biology and biological diversity, you may wish to structure your interventions in line with the CBD objectives, focusing on how the different applications of synthetic biology relate to each of these objectives at all levels, i.e. genetic, species and ecosystems, as well as at local and global scales. Also, it will be helpful if you could indicate the source of information, where appropriate, by posting links or articles (including, but not exclusively, scientific peer-reviewed journals, working papers, CBD Technical Series 82, etc.)

I understand that you all are busy and have other professional and personal commitments.  I thank you for your consideration and commitments, for taking time and efforts to participate in this forum and hope that this forum will be informative, constructive and mutually beneficial.

Best regards,
Ryo Kohsaka
(edited on 2015-04-27 01:11 UTC by Ms. Manoela Miranda)
posted on 2015-04-27 01:09 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6771]
Dear Participants of the Online Forum on Synthetic Biology,
Greetings from Malaysia.
My name is Kok-Gan Chan, am from the University of Malaya and also the member of GMAC (Genetic Modified Approving Committee) in Malaysia under the Ministry of Natural Resources and Environment. I work as High Impact Research Coordinator (HIR) and my research is on the use of next generation sequencing and genome editing and biosensor construction using synthetic biology.

First of all, I thank Ryo Kohsaka for moderating this online forum on Synthetic Biology.

As Ryo has pointed put the first thing is: “In this first round of discussion to support of the work of the AHTEG, participants of the Online Forum are invited to exchange views on how to address the relationship between synthetic biology and biological diversity”.

But before doing so, I think it is desirable to have a working definition of “synthetic biology” as this will put the discussion in perspective. This is because there are many views and definitions on synthetic biology. This is a grey area where no consensus among experts (see CBD Technical Series no. 82, pg 12-13). In page 19 of CBD Technical Series no. 82, Box 1 listed 7 definition of synthetic biology which clearly illustrates diverse opinion of synthetic biology.

According to Cartagena Protocol (Article 3(i)), “modern biotechnology” is
defined as the application of: (a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. On this perspective, once the LMO or its product or component is formed using the synthetic biology approach, and it will triggers the Art. 3(i) and call for biosafety regulation under the Cartagena Protocol.

In the light of this definition, even though synthetic biology is capable to be used to create de novo LMO, its products or components, as long as it fulfil the scope of Cartagena Protocol Art. 3(i) above, then it will call for biosafety regulation under the Cartagena Protocol.

In a nutshell, to address Ryo's call in his forum [#6760] second last paragraph, this is my view:

To address the relation between synthetic biology and biological diversity; there are 2 aspects to consider as synthetic biology work as a double-edged sword:

1) unlike classical genetic engineering, synthetic biology can possibly increase biological diversity especially when it involves “de novo” LMO,

      2) the artificial traits introduced into the new LMO may be too invasive that will diminish the biological diversity.

As such, it is foreseeable that synthetic biology will affect genetic, species and ecosystems. But whether it has an impact on local and global scales, that depends on the type of LMOs, its products or components.

Thank you.

Dr Kok-Gan Chan
University of Malaya, Malaysia
posted on 2015-04-27 07:56 UTC by Dr Kok Gan Chan, Malaysia
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6796]
Thank you Ryo Kohsaka for your words of welcome.  My name is Jim Louter and I work with Environment Canada managing a small group of scientific staff conducting environmental risk assessments on a daily basis.

Thank you also for your words of clarification regarding the definition of 'biotechnology'  and conclusion that synthetic biology falls within it's scope. 

As I see the question posed in the title of this discussion, it is really similar to the question about the relationship between an LMO (under the CPB) and biodiversity and that question is further resolved by looking at annex III of the Protocol.  In other words, in our context, the relationship between an organism (whether an LMO, a GMO, naturally occurring, or a product of SB) and  'biodiversity' is described by the results of a risk assessment.  The risk assessment determines whether the organism (which in this case, is a product of synthetic biology) will (or will not) have an adverse effect on a component of the environment.  If the product of synthetic biology is not 'alive', the risk assessment model would be different but the basic principles of risk assessment would still apply.
(edited on 2015-04-27 20:23 UTC by Mr. Jim Louter)
posted on 2015-04-27 20:22 UTC by Mr. Jim Louter, Canada
This is a reply to 6771 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6802]
Dear participants,
Firstly, I thank Ms. María Andrea Orjuela Restrepo for moderating this online forum and also special thanks to the CBD secretariat.

My name is Kok-Gan Chan from the University of Malaya and also the member of GMAC (Genetic Modified Approving Committee) in Malaysia under the Ministry of Natural Resources and Environment. I work as High Impact Research Coordinator (HIR) and my research is on the use of next generation sequencing and genome editing and biosensor construction using synthetic biology.
As pointed out by Maria who ask for the discussion on the 3 topics, which I will deal with them in turn:
As to the 1st issue:
• What are the similarities and differences between LMOs, as defined in the Cartagena Protocol, and the living organisms that are currently being developed through synthetic biology?

As I have mentioned in another reply, there is a need for the AHTEG to have a working definition on synthetic biology so as to put all discussion in perspective. Also, I agree with other participants who call for focusing on the “product” of synthetic biology instead of the “process”.
To address this first issue, to certain extend, synthetic biology is the extension of the modern biotechnology as per Article 3(i) of the Cartagena Protocol, as such it does not seem to have significant difference LMOs, and LMOs that have been developed via synthetic biology.
The 2nd issue:
• Taking into account the previous question, would your evaluation of the above similarities and differences between LMOs and living organisms developed through synthetic biology change when considering the foreseeable technological developments of synthetic biology?What are the similarities and differences between the components and products of “modern biotechnology”, as defined in the Cartagena Protocol, and the components and products of synthetic biology?

As said, as synthetic biology is truly a multi-disciplinary technology, so it is foreseeable, at least to me, the evaluation of similarity and differences between LMOs developed by synthetic biology is likely to change, and hence call for more detailed discussion.
But as synthetic biology allow synthesis of LMOs components or products without the need of any biological system, then it may fall out of the scope of Cartagena Protocol.

The 3rd issue:
• How do the different areas of synthetic biology, including DNA-based circuits, synthetic metabolic pathway engineering, genome-level engineering, protocell construction and xenobiology, overlap or differ from modern biotechnology as defined in the Cartagena Protocol?
To address this, one must always refer to the original text of the Article 3(i) of the Cartagena Protocol, and I quote:
(i) “Modern biotechnology” means the application of:
a. In vitro nucleic acid techniques, including recombinant
deoxyribonucleic acid (DNA) and direct injection of nucleic acid  into cells or organelles, or
b. Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and
that are not techniques used in traditional breeding and selection;
Again, these areas (DNA-based circuits, synthetic metabolic pathway engineering, genome-level engineering, protocell construction and xenobiology) of synthetic biology may call for regulation under the Cartagena Protocol as long as it fulfills this definition of Art. 3, and it is opined that  they do but subject to the exception of LMOs components or products without the need of biological system, which apparently is chemical in nature.

Thank you.

Dr Kok-Gan Chan
University of Malaya, Malaysia
posted on 2015-04-28 04:51 UTC by Dr Kok Gan Chan, Malaysia
This is a reply to 6802 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6804]
I want to discuss the following sentence of Dr. Chans post:
"But as synthetic biology allow synthesis of LMOs components or products without the need of any biological system, then it may fall out of the scope of Cartagena Protocol."
This looks for me like the old technique based view on synthetic biology.
First what is the difference between an organism, component or product which is synthesized with or without any biological system?
I would say none. Lets talk about an LMO which is a) synthesized and assembled without biological systems or b) the same organism has been produced and assembled by genomic engineering of a living organism.
The end product is in both cases an LMO and should be handled as an LMO and not differently. This is my opinion, every other perspective on this would result in a profound problem to identify (and to argue why this should be important) from which source does the LMO came from.
Besides this remark to a process based decision I totally agree with Dr. Hideyuki Shirae who pointed out that the definition and discussion should focus on any LMO (or other product) which contains at least one component (i.e. PNA instead of DNA or other xenobiology bases or molecules) which is not found in natural organisms on earth. Such an organism is really new and therefore might (not must) harbour a new risk, which should be evaluated first.

Best regards,

Frank Hartung
(edited on 2015-04-28 05:59 UTC by Mr. Frank Hartung)
posted on 2015-04-28 05:58 UTC by Mr. Frank Hartung, Germany
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6805]
Dear colleagues,

My name is Piet van der Meer, and my daily activities revolve around teaching biosafety the Ghent University and the Free University of Brussels in Belgium and providing support to governments and international organisations.  I participate in this forum for the Public Research and Regulation Initiative (PRRI), which is an international NGO by and for public researchers active in research on modern biotechnology for the public good.

Synthetic biology is gaining increasing interest of public researchers worldwide, as it can - inspired by nature - be used to redesign biological systems in order to better understand life processes and perform beneficial functions. SynBio is widely considered to be among the top emerging technologies with the greatest potential to provide solutions to the most compelling social, economic and environmental challenges (see also: http://www.prri.net/synthetic-biology/).

PRRI is therefore very pleased with public discussions as this on line debate on synthetic biology, and commends the CBD Secretariat for organising this debate and the moderators for making their time and expertise available.

Having said that, I also have to share that I am concerned about the approach taken for this on line debate.

Over the years I have participated – and am participating  at this very moment - in many on line discussions under the Biodiversity Convention and the Biosafety Protocol, and I noted that this discussion on Synbio takes a different approach by inviting parallel discussions on three different topics.

While we have already seen quite some fascinating exchanges, I urge the moderators and CBD Sec to slightly change the modus operandi for this debate to discussing only one topic at the time and that the fist topic should be topic 3, i.e. about an operational or working definition.

My reasons for this suggestion are:

1. Discussing various topics at the same time results in duplication and confusion. We can already see that some interventions are pasted under multiple topics, and that the topic of one discussion (e.g. definition) is also discussed under the thread of another.
2. This kind of on line discussions have a logical sequence, whereby typically the first topic is ‘definition’, i.e. what the participants mean by synthetic biology when they make interventions, and whether there are common elements in the various descriptions of SynBio. It is not helpful to discuss similarities between organisms produced through SynBio and LMOs if we do not know what people mean when they refer to Synbio. From the various posts we can see that SynBio means different things to different people, which is a good  reason to take a step back there and reflect on that, before discussing other topics.
3. It is already quite some work to adequately follow and contribute to one thread under a particular topic, let alone three.  This is compounded by the fact that at this very moment there are also on line discussions going on other topics such as on socio-economic considerations in decision making, environmental risk assessment, and biosafety related databases. This coinciding of on line debates on many different topics is counterproductive to the very purpose of on line discussions.

I apologise for having to place this post under all three topics of this online debate, but I would like to draw the attention of all participants to this. For similar reasons, I will also bring the general concern about coinciding on line debates to the CBD Secretariat.

I hope that in this on line discussion the moderators will agree to discuss one topic at the time and that we continue first with the discussion on what is now topic 3, e.g. the discussion about an operational definition, to which I will make substantive contributions later in the debate.

Looking forward to some excellent debates, and with greetings to all!

Piet
posted on 2015-04-28 07:33 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 6805 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6810]
I agree with Piet regarding the benefits of modifying the online forum format to focus on one topic and thread at a time.

Thanks you,

Bruce
posted on 2015-04-28 10:11 UTC by Mr. Bruce Dannenberg, Phytonix Corporation
This is a reply to 6805 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6811]
I agree with Piet regarding the benefits of modifying this on-line forum format to one topic and thread at a time.

Thanks you,

Bruce
posted on 2015-04-28 10:14 UTC by Mr. Bruce Dannenberg, Phytonix Corporation
This is a reply to 6811 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6813]
Hi,

My name is Borys Wrobel; my background is molecular biotechnology and computer science, and I teach complex systems (systems biology) to biotech students at the Mickiewicz University in Poznan, Poland.

I second Piet's motion; as these messages accumulate it is difficult to follow each thread overlapping in subject. Better to deal which each subject at a time and if there's a need to go back to some unresolved issue in order to progress on the next topic, we can do so.

Cheers,
Borys
posted on 2015-04-28 10:46 UTC by Mr. Borys Wrobel, Institute of Molecular Biology and Biotechnology, Adam Mickiewicz University in Poznan
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6818]
Dear Colleagues,

My name is Uwe Sonnewald and I am head of Biochemistry at the Friedrich-Alexander-University Erlangen-Nuremberg. I joined the online discussion forum as member of the Central Committee of Biological Safety (ZKBS) of Germany. My major research area is Plant Molecular Biology and Biochemistry and I deal a lot with transgenic plants. My interest in SynBio comes from our approaches to modulate metabolic pathways in vivo but recently also cell-free.
I must admit that I am overwhelmed by the large number of emails entering my email account, which are very hard to follow.  I also must admit that I have no experience with online discussion in the given format and I find it hard to figure out where I can substantially contribute.
For me it seems logical to start with the definition of SynBio and to see which parts are likely to be relevant to biodiversity. Here I am in complete agreement with Paul Freemont. I also agree with Peet van der Meer that parallel discussions make life harder and streamlining would be welcome.
May be based on the definition given by Paul Freemont we could jointly start working on a broadly acceptable definition. For me the overall definition “Synthetic biology aims to design and engineer biologically based parts, novel devices and systems as well as redesigning existing, natural biological systems” given by Paul Freemont sounds acceptable.
Based on this we can sub-divide the applications in living and non-living systems. For biodiversity only living systems count. These can be classified as modified existing systems or (in the future) unnatural novel systems. At present most applications deal with existing organisms which are more or less modified. They can be classified as LMO´s and the use of these organisms falls under GMO regulations. More complex are the unnatural, living systems…..

Best regards,

Uwe
posted on 2015-04-28 14:30 UTC by Mr. Uwe Sonnewald, Germany
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6824]
POSTED ON BEHALF OF LÁZARO REGALADO

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Dear colleagues and participants,

I’m  Dr Lázaro Regalado  (Cuban National Center for Biosafety. Ministry of Science, Technology and Environment). I would like to highlight the issue of how to address the conservation of biological diversity

Topic 1: How to address the relationship between synthetic biology and biological diversity

• The conservation of biological diversity

Article 8(g) (CBD) requires Parties, as far as possible and as appropriate, to “establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.” Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82, 118 pages.

Alleged environmental harm could, for example, also include that organisms resulting from synthetic biology techniques displace existing species because of engineered fitness advantages and become invasive

… the obligation to prevent transboundary harm depends on the particularities of the specific case and is mainly retrospective. International law provides only very limited means to obtain advance provisional measures in order to stop activities that could be in breach of international obligations. Therefore, the duty not to cause transboundary harm may not be a sufficient instrument to address potential negative impacts from synthetic biology techniques, in particular potential impacts of very low probability but very high magnitude.
Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82, 118 pages.

Cartagena Protocol is a document whose bases can address synthetic biology, an increasingly emerging technology, in this regard:

• Definitions of Living Organism and Living Modified Organism could be maintained and improve the term of modern biotechnology in the Protocol framework, in order to cover synthetic biology living entities.

• Apply principles such as:
- The principle or precautionary approach ( Rio Declaration of 1992)
- The principles of licensing and inspection.
- The principles of "step by step" and "case by case"
- The principle of traceability.

• Articles 15 and 16 of the Protocol are basically pertinent.

In principle, in order to protect the environment, the challenges constituted by their potential for damage to biodiversity and human health should be subjected to risk assessments from the very beginning of the research design itself to make decisions at early stage, as a prerequisite for approval regardless of their intended peaceful use, and should continue to have provided an adequate risks management.

It’s hard to cover all possible impacts such as dual use technologies of synthetic biology while estimates that the framework to address this issue is the Convention on the Prohibition of the Development, Production and Stockpiling of Biological and Toxin Weapons and on Their Destruction (BTWC) another example could be the direct impact on human health in our view related with the WHO and also with BTWC.

Respectfully,
Dr Regalado
posted on 2015-04-28 20:17 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6832]
Dear Dr Kohsaka and other participants of the online forum

Many thanks for the opportunity to offer perspectives on how the CBD might address the relationship between synthetic biology and biological diversity. My name is Jim Thomas, I am Programme Director with the ETC Group. We are an international  civil society organisation that has been closely tracking developments in Synthetic Biology since 2006 and are founding members of the International Civil Society Working Group on Synthetic Biology. I am submitting these comments only on behalf of ETC Group.

As requested i have attempted to enumerate below some of the ways in which the issues of Synthetic Biology and Biological diversity inter-relate, structured according to the three objectives of the convention. I notice that Dr Kohsaka requested references and reports where possible.For reasons of time  I have not footnoted the below but am happy to provide references and sources for any part upon request. I would refer fellow participants to an extensive review of this topic undertaken by the International Civil Society Working Group on Synthetic Biology and submitted to the CBD in 2011:https://www.cbd.int/doc/emerging-issues/Int-Civil-Soc-WG-Synthetic-Biology-2011-013-en.pdf


• The conservation of biological diversity

1. Direct impact on Biodiversity, health and integrity of species and ecosystems from introduction of engineered organisms, components and products on biological diversity - i.e. Environmental Biosafety., 

As with other LMO’s the intentional or accidental release of Syn Bio Organisms (SBO) may theoretically affect biodiversity at the genetic and ecosystem level through gene flow, outcrossing, invasiveness, changes in population structures etc. Of particular concern is the synthetic modification of common micro-organisms (yeast, algae, e-coli) for high yield production of industrial products or enzymes (e.g. biofuels, chemicals, flavors and fragrance molecules etc) and the possible toxicity or disruptive effect of those secreted compounds on soils, food webs, pollinators and biodiversity should the organisms get into the open environment and successfully reproduce. An example concern in this regard would be the impact of organisms producing cellulases for cellulosic biofuels escaping into soils and degrading cellulose in the soil with impact on food webs or engineered algae designed to secrete a fuel molecule or enjoying enhanced photosynthesis escaping into waterways.

In the area of biosafety i believe there are some specific applications in the Syn Bio space that deserve especially close attention because of their potential impact on biodiversity:

> Gene Drives - These promise to alter population structures and to deliberately  ‘drive’ engineered traits (sterility, resistance etc) through an entire population - this sort of genetic-driven population-level engineering is novel and should be approached with extreme caution.

> Enhanced photosynthesis - applications of synthetic biology (including genome editing) to increase photosynthetic abilities of algae, crops etc are on the rise and constitute a significant intervention that could increase invasiveness,  impact carbon and oxygen cycles etc.

> De-extinction - engineering of organisms to mimic previously extinct species and subsequent reintroduction or engineering of extant species to mimic commercially valuable strains/varieties of the same could have impacts equivalent to introduction of foreign species.

> SynBio sensors and bioremediation - use of synthetic organisms as an environmental  sensing or monitoring platforms. Or release of synthetic biology organisms for cleaning/extracting contaminants.

Additionally the range of techniques now under use  may require development of new risk assessment approaches especially where there is a high degree of novelty. (e.g. genome editing techniques such as CRISPR which appear to have off target effects)  There is already a growing literature on unexpected and non-target effects from the  first generation LMO’s (see database here: http://natureinstitute.org/nontarget/report_class.htm), it would be strange to think that the collection of novel transformation techniques clustered round ‘synthetic biology’ (including  ‘genome editing’) won’t in time throw up further unexpected effects.


2. Indirect impacts on Biodiversity arising from industrial application of Synthetic biology techniques and products to the economy .

While proponents of the ‘bioeconomy’ tout the economic and industrial changes flowing from application of Syn Bio to production  as potential goods (use of Biomass-based fuels in place of petroleum, novel enzymes to improve efficiency of industrial processes etc) there is also plenty of reason to be concerned that structural changes in the economy flowing from widespread industrial use of Syn Bio techniques and organisms could negatively impact biodiversity: This include increased demand for biomass as a feedstock and associated changes in land use (and ocean use),  preference for ‘energy crops’ leading to agronomic changes, pressure on  forests, grasslands, deserts and coastal regions to transform into biomass sources, increased use of water etc Additionally a suite of Syn Bio applications are now in development that are intended to aid in extractive industries (e.g. biomining applications, developing microbial consortia to assist in shale gas extraction) as well as to convert natural gas into high value products such as fuels and fish feed. If such applications scale up they could enable expansion of mineral extraction with increased pressure on biodiversity.

3. Impacts on biodiversity arising from changes in conservation practice

Speculative proposals to employ the techniques of synthetic biology in service of conservation may one day theoretically deliver intended benefits (e.g. reintroduction of extinct species or preservation of  endangered species by combatting zoonotic diseases with synthetic viruses ) however as we have seen with previous poorly thought-through technofixes (e.g. switch to ethanol biofuels or introduction of exotic species or new farm management techniques) a poorly thought-through intervention can backfire in the real world. More significantly the advancement of technical fixes for conservation problems  as an approach could lead to a switch in funding away from in situ conservation and community led conservation of biodiversity toward speculative, high tech approaches that cut out communities or overall decreases/changes in real funding and support.


• The sustainable use of the components of biological diversity

1. Indirect biodiversity impacts associated with changes in Natural products markets

Much of the industrial activity in synthetic biology is currently focused on synthesis of high value compounds currently extracted from natural sources  - e.g. synbio-derived vanillin that is sold as ‘natural’ thereby challenging  botanical vanilla - or synbio-derived patchouli essence displacing botanical patchouli. Some of these impacts may be positive for biodiversity (e.g. Evolva claims that biosynthesis of Agarwood oil in yeast might reduce pressure on south east Asian forests but such claims need to be empirically tested and examined) others might harm biodiversity -eg if natural vanilla prices are reduced by competition from synbio vanillin falsely labelled as natural the effect may be to force impoverished vanilla communities to unsustainably clear forest for rice growing. Syn bio algal oil that challenges coconut and babassu oil markets could shift the economics to disfavor sustainable agroforestry systems. Small producers who currently grow niche crops for flavor, fragrance and cosmetic markets may suffer a loss of livelihood or move from the land resulting in loss of agroecologcial farming systems  etc.

• The fair and equitable sharing of the benefits arising out of the utilization of genetic resources

1. Changes in concept of a genetic resources and the implications-  

The ‘digital’ nature of synthetic biology with underlying techniques to sequence, store, digitally manipulate and then synthesize or ‘edit’ genomes creates significant challenges to how genetic resources are accessed, exchanged, transformed, stewarded  and protected. Fast  ‘sequencing by synthesis’ combined with online movement of digital DNA sequences and subsequent re-editing and synthesis  across borders can evade ‘access and benefit sharing’ obligations, potentially emptying the Nagoya protocol of purpose. The underlying concept of a ‘genetic resource’ is challenged when genetic sequences can be kept and manipulated ‘in silico’ rather than in vitro and when notions of genes give way to engineering-driven notions of ‘parts’, ‘devices’ or ‘circuits ‘. Engineering and subsequent patenting of key metabolic pathways can enable private players to make monopoly claims on biosynthesis of hundreds of natural products at once and with the tools of synthetic biology such players can potentially utilize such patents to steal away markets from communities who traditionally stewarded natural products - a new pathway of synbiopiracy.

Best

Jim Thomas
ETC Group
posted on 2015-04-29 04:47 UTC by Mr. Jim Thomas, ETC Group
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6847]
Dear participants,
my name is Swantje Strassheim and I work for the German Federal Office of Consumer Protection and Food Safety in the department for genetic engineering, where I am charged with the monitoring of Synthetic Biology on behalf of the German Central Committee for Biological Safety (ZKBS).
Like several other participants in the online forum I do find it quite difficult to establish the relationship between synthetic biology and biological diversity, if we do not have an operational definition of synthetic biology. If we want to effectively discuss the relationship between synthetic biology and biodiversity, we need to differentiate between synthetic biology and modern biology.
In agreement with Hideyuki Shirae I think that synthetic biology –at the moment- is more likely an extension of modern biotechnology as it is described in the Cartagena protocol. To my mind, however, organisms containing non-natural genetic sources such as XNA still fall under the LMO definition in the Cartagena protocol as this definition does not state the nature of the genetic material. Therefore, synthetic biology so far is likely to have no influence on biodiversity other than that anticipated for LMOs or, for example, traditionally bred crops.
I also agree with the viewpoint stated by several participants that we should not consider the techniques, but rather the products resulting from synthetic biology.

Best regards
Swantje Strassheim
posted on 2015-04-29 15:19 UTC by Ms. Swantje Strassheim, Germany
This is a reply to 6847 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6855]
Dear participants,

I’m Leonardo Bocanegra from the Research Institute on Biological Resources Alexander von Humboldt from Colombia and It’s an honor to participate in this Forum.

Interactions between new technologies and biodiversity are given at different levels, therefore, by identifying these levels is possible to address our actions. To understand a little this point, it must first be noted that the development of these technologies responds to a potential application for financial gain, and this interest will determine its use; hence their range of action covers different known productive sectors, with both positive and negative considerations that are associated with how the use of technology is made.

Unlike genetic engineering, that "cut and paste" existing genes between species, synthetic biology aims to build unique and novel organisms from knowledge of the biology of existing organisms in nature or rebuild what already exists to make it better. In this sense, and taking under consideration the three fundamental principles of the Convention on Biological Diversity, the relationship between biodiversity and development for those countries that have a huge biodiversity would be affected in the light of synthetic biology in where genetic circuits are generated in a computer (PC) and then expressed them in biological models to produce different compounds, and considering that in most of cases the economic factor prevails into decision-making, pointing to that the products of this technology will impact the way in how we perceive biodiversity  and its real value.

Although synthetic biology currently based their findings on information on existing biodiversity, the synthetic biology uses different areas of knowledge for the development of a product, making a traceability activity to determine whether development actually done was by a 100% synthetic model or a particular genetic resource or its information was used, could be not possible. This highlights as the Fair and Equitable Sharing of benefits  for the use of genetic resources, one of the fundamental principles of the CBD might lose its meaning, since the real value is in the ability of countries to generate patents in this field, without this meaning that the application of intellectual property systems are detrimental, quite the reverse, it is necessary that less developed countries can make use of these technologies for they can take advantage of them and turn them a factor of development by generating its own property right on its genetic resource.

All this makes necessary an analysis of what kind of relationship we want to study, since this relations going to determine the value of biodiversity and this is of utmost importance because they will define the perception of citizens. Hence the delicate line in seeing products of synthetic biology like a way to replace natural satisfiers reaching discussion where it have been proposed that artificial carbon catchment systems can justify increasing agricultural frontier, urban expansion among others.
(edited on 2015-04-29 21:47 UTC by Mr. José Leonardo Bocanegra Silva)
posted on 2015-04-29 21:45 UTC by Mr. José Leonardo Bocanegra Silva, Colombia
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6857]
Dear participants,

I would like to share some inputs on topic 1: How to address the relationship between synthetic biology and biological diversity.

The synthetic biology is the application of science, technology and engineering to facilitate and accelerate the design and engineer (manufacture and or modification) biologically based parts or genetic materials, novel devices and systems in living organism to alter living or non living materials. (European Commission 2014). Synthetic biology includes the “de novo” synthesis of genetic material and an engineering-based approach to develop components, organisms and products; and, builds on modern biotechnology methodologies and techniques such as high throughput DNA technologies and bioinformatics. Synthetic biology aims to design and engineer biologically based parts, novel devices and systems as well as redesigning existing, natural biological systems (RAE 2009).

Synthetic biology uses parts or living organisms or biological systems to make or modify products or process. In this regard, it is related with the three levels of biodiversity, genetics, species, ecosystems and ecosystems process. The conservation of biological diversity needs to address rules to protect from different organisms, products or process from synthetic biology that may have negative impacts on genetics level (e.g. native genetic erosion, persistence and transfer of genetic material to other microorganisms), species population (e.g. invasive species, niche substitution, transfer of genetic material to wild populations via vertical gene transfer and introgression, food chain) and ecosystems structure and processes (e.g. increase in the utilization of biomass and change use land, pollination, soil fertility). It is crucial apply the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development. There is a big challenge to develop and improve studies to risk assessment.

The Biodiversity Convention has as one of its issues the biosafety. This concept refers to the need to protect human health and the biodiversity, especially ecosystem processes, from the possible adverse effects of the products of modern biotechnology as synthetic biology. It is relevant to recognize potential human well being of products and process from synthetic biology, particularly for food, agriculture, industrial, and health care. In this framework, it is very important to consider sustainable use of the components of biological diversity. The synthetic biology uses organisms, parts or derivatives of living or non living materials; hence, this use should be compatible with sustainable use of the components of biological diversity. Likewise, it is necessary to address risk assessment, risk management, monitoring, capacity building, transboundary movements, public awareness and participation on this issue.

The synthetic biology makes products and process that demand markets. This technology uses organisms, parts, derivatives of living organism from nature or its information; hence, there should be fair and equitable sharing of the benefits arising out of this utilization. The benefits should be for conservation of biological diversity components.

It is relevant to seek to ensure the development of appropriate procedures to enhance the safety of synthetic biology, pursuit to reduce all potential threats to biological diversity, taking also into account the risks to human health. The synthetic biology could benefit some technologies to remediate ecosystems or other human well being, but we need a regulatory framework to enhance equilibrium between maximum benefits from the potential synthetic biology products or process and minimizing the possible risks to the ecosystems, biodiversity and to human health. There is necessary to address especial consideration in domestic rules and international agreement on this matter to the centres of origin or genetic diversity.

It is relevant to seek to ensure the development of appropriate procedures to enhance the safety of synthetic biology, pursuit to reduce all potential threats to biological diversity, taking also into account the risks to human health. The synthetic biology could benefit some technologies to remediate ecosystems and human well being, but we need a regulatory framework to enhance equilibrium between maximum benefits from the potential synthetic biology products or process and minimizing the possible risks to the ecosystems, biodiversity and to human health. Furthermore, there is need to address especial consideration in domestic rules and international agreement on this matter to the centres of origin or genetic diversity.

Best regards,

Dr. Marina Rosales Benites de Franco
IUCN’s Commission on Ecosystem Management
(edited on 2015-04-29 22:45 UTC by Ms. Marina Rosales Benites de Franco)
posted on 2015-04-29 22:44 UTC by Ms. Marina Rosales Benites de Franco, IUCN
This is a reply to 6832 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6862]
Dear all

Greetings from Third World Network in Malaysia and thank you for the interesting discussion.

I found the post by Jim Thomas (#6832) to be useful and am in agreement with what he says.

In addition, approaching the issue from a regulatory perspective, the relationship between synthetic biology and biological diversity should be addressed on the basis of the objectives of the Convention on Biological Diversity (CBD). This obliges Parties to ensure the conservation of biological diversity, the sustainable use of its components and equitable sharing of the benefits arising out of the utilization of genetic resources. Articles 7, 8, 13, 14 and 17 of the CBD appear to be particularly relevant in relation to synthetic biology.

In so far as organisms resulting from synthetic biology techniques meet the definition of living modified organisms (LMOs) under the Cartagena Protocol on Biosafety, then the provisions of the Cartagena Protocol and its Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress should be applied. These are inclusive of a precautionary approach, advanced informed agreement, risk assessment and risk management, socio-economic considerations, public participation, and liability and redress.

Drawing on the above, the relationship between synthetic biology and biological diversity could be addressed by ensuring that the direct and indirect risks to the conservation and sustainable use of biological diversity, of organisms, components or products derived from synthetic biology techniques, are assessed prior to any introduction to the environment or placing on the market, in a precautionary manner, taking also into account risks to human health and socio-economic considerations, especially with regard to the value of biological diversity to indigenous and local communities. Damage resulting from the organisms, components and products of synthetic biology techniques must also be addressed through a liability and redress regime.

kind regards
Lim Li Ching
Third World Network
posted on 2015-04-30 06:08 UTC by Ms. Li Ching Lim, Third World Network
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6868]
This should be done through examining the potential impacts of synthetic biology and its relevance to the three objectives of the Convention on Biological Diversity (CBD): the conservation and sustainable use of biodiversity and the fair and equitable sharing of benefits arising from the utilization of genetic resources.

In line with the precautionary principle (The key element when dealing with new and emerging scientific and technological issues), Parties to the CBD should :
1.  ensure that Living Modified Organisms and synthetic genetic parts produced by synthetic biology are not released into the environment or approved for commercial use until there is an adequate scientific basis on which to justify such activities;
2. ensure that due consideration is given to the associated risks for biological diversity, also including socio-economic risks and risks to the environment, human health, livelihoods, culture and traditional knowledge, practices and innovations of living modified organisms and synthetic genetic parts produced by synthetic biology.
3. Analyse the adequacy of existing assessment frameworks and identify gaps in knowledge and methodologies for assessing the potential negative impacts of synthetic genetic parts and living modified organisms produced by synthetic biology on biodiversity and the environment.
O.A. El-Kawy
(edited on 2015-04-30 10:39 UTC by Mr. Ossama AbdelKawy)
posted on 2015-04-30 10:29 UTC by Mr. Ossama AbdelKawy, Mauritania
This is a reply to 6857 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6875]
I would like to build on the contribution made by Marina Rosales Benites de Franco.  I am Kent Redford with Archipelago Consulting and also a member of IUCN's Protected Areas and Species Commissions.  I was trained as an ecologist and have been working in the conservation world for  20+ years.  I have been working to build discussions between the synthetic biology community and the conservation community.

Much of the discussion to date has been on synthetic biology and organisms modified/created through its techniques as threats to biological diversity.  Much of this discussion has treated biodiversity as a single entity whereas, as Dr Rosales Benites de Franco reminded us, it consists of at least the genetic, species and ecosystem components.  And some of us believe that it is useful to divide these components into three attributes:  composition, structure, and function.

Much of the research that has been done on the ecological side does not provide clear indications of how synbio-modified organisms would impact the species and ecosystem components with a bit more understanding on the genetic component.  And the attribute that might be most affected is the "compositional" one. 

But what if we wanted to consider synbio-modified organisms as ways of helping out the conservation of biological diversity?  How should we think about the potential costs versus the potential benefits of helping to address currently intractable problems like incurable diseases like white-nose syndrome in bats or chytrid in amphibians?  We know what is happening in the absence of a solution so what risk framework should be use when considering synbio-based solutions?

I raise this issue as I think it important for this group of experts and deep thinkers representing such a broad range of stakeholders to ask questions concerning the full range of possible interactions between synbio and biological diversity.  I will look forward to reading your responses.

Kent H. Redford, Archipelago Consulting, Maine, USA
posted on 2015-04-30 12:41 UTC by Mr. Kent Redford, Archipelago Consulting
This is a reply to 6875 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6878]
Dear all,
Thanks to mr. Kohsaka for chairing this discussion and thanks to verybody for this interesting discussion sofar. My name is Boet Glandorf, and I work as a senior risk assessor in the Dutch GMO Office at the National Institute of Public Health and the Environment for more than 15 years. It is therefore from my practical experience in the risk assessment of GMOs that I would like to share with you my thoughts about the relationship between synthetic biology and biological diversity.

Synthetic biology may create major new possibilities to conserve and to contribute to biological diversity, resulting in sustainable use of biological diversity and its components. Current examples are mentioned in the recent CBD report (http://www.cbd.int/ts/cbd-ts-82-en.pdf) and include organisms producing biofuel or synthetic products replacing those harvested from natural sources and increased agricultural production of plants. 

However, organisms obtained by synthetic biology may also pose risks for biodiversity on all levels.
For the now and the near future, we foresee that organisms produced with synthetic biology (synbio) fall within the definition of an LMO. Consequently the risk assessment framework for LMOs applies and potential risks can be assessed on a case-by-case basis.

Most of the organisms obtained by synthetic biology sofar are only meant to be grown under conditions of contained use. The experience with LMOs so far indicates that these containment conditions suffice to prevent exposure to the environment, in a way that it does not lead to adverse effects on biodiversity. For organisms produced by synthetic biology intended for their release into the environmental the current risk assessment framework for LMOs seems to be applicable for the near future.  Risks for human health and the environment of organisms produced by synthetic biology can therefore be adequately assessed on a case-by- case basis. Depending on new developments in synthetic biology,  the risk assessment strategy as applied to LMOs may have to be adapted in the future.
posted on 2015-04-30 13:09 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6892]
Hello everybody,

My name is Caroline Burgeff.  I work in Conabio (Mexico) mainly in GMO risk assessment and biosafety issues and I have an agronomy/plant molecular biology/biotechnology background.
I am grateful  to de SCBD for the opportunity to join this online forum, to the moderators for their guidance in this process and to every participant for exchanging their views  on the subjects discussed here.

In relation to this  first topic on how to address the relationship between SB and Biological diversity,   I believe they can be addressed in two ways:

The relationship between conservation of biological diversity and the sustainable use of the components of biological diversity  and SB should be addressed   focusing on the possible effects (positive or negative) that the SB technology  could have on the former. In this context   environmental release of SB applications should be evaluated through adequate risk assessments methodologies in case by case basis and from an interdisciplinary approach.  In the case of  SB developments  for contained use, even if in many cases the probability of these organisms to survive “outdoors”  might be low, the possible  effects to the environment,  biological diversity and its sustainable use  in cases of accidental release  should be  evaluated/estimated.

On the other hand,  biological diversity at the gene level,  is in a way the original “source” of components for  synthetic biology developments or applications ; even if synthetic biology components might be synthetized  and/or designed in a lab, they finally are inspired/based,  at different levels, on  biological processes and  the gene diversity existing in nature (even xenobiology  is based in informational molecules  whose expression can be directed). For these reasons, the development of many of the components and synthetic biology applications   might need to consider the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.


Kind regards,

Caroline
posted on 2015-04-30 21:43 UTC by Ms. Caroline Burgeff, Mexico
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6925]
My name is Matthew Legge and I work with the Religious Society of Friends (Quakers) in Canada. Quakers at the local congregational level have undertaken a multi-year process of collective discernment about the ecological, economic, and spiritual dimensions of synthetic biology. Building from this, we would like to offer a few insights we feel important to the topic of how to address the relationship between synthetic biology and biological diversity.

It is clear to us that the profit motive does not necessarily work to support the goal of the preservation of biological diversity or the fair sharing of costs and benefits between developed and developing countries. At present, there appears to be a concentration of decision making power and control related to synthetic biology in the hands of a limited number of stakeholders, most of whom are driven primarily by a profit motive and who do not bring an ecological perspective to their decisions.

As Jim Thomas (post #6832) noted, there are major emerging threats which synthetic biology poses to biodiversity, in addition to potential benefits. It is difficult to envision an appropriate response to the threats if the technical and commercial dimensions of synthetic biology (representing only two limited dimensions) remain such a strong focus of our collective thinking and discussions.

The recent CBD Technical Series 82 publication on Synthetic Biology acknowledged critiques of synthetic biology's being predicated on deleting or simplifying natural complexity, noting the view "In short, that emergence, and unpredictable change and behaviour are what ultimately characterize life itself." (p.21). Quakers echo this sentiment. We also feel that due respect for the complexity of all creation is a prerequisite for the successful stewarding of biological diversity.

The framing of an issue like synthetic biology makes a significant difference to the path forward which is chosen. Therefore, if synthetic biology continues to be framed almost exclusively in a narrow and technical sense with few perspectives other than the "biology as machine" metaphorical approach, where will the motivation to use the precautionary principle in support of the maintenance of biological diversity come from? Will risks be appropriately acknowledged? Would it not be important to actively incorporate the perspectives of other stakeholders with other relevant types of expertise such as public health, ecology, and the rights of traditional knowledge holders including Indigenous Peoples? I am unclear on the extent to which this is happening currently and do feel that this appears a significant gap, though I would be happy to be corrected!
posted on 2015-05-01 20:21 UTC by Mr. Matthew Legge, Canadian Friends Service Committee (Quakers)
This is a reply to 6925 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6926]
Dear participants,

My special thanks to Ryo Kohsaka for agreeing to moderate this round of discussions and to the SCBD for preparing such a great technical document to serve as background material for these discussions.

I would also like to share my view about the relationship between synthetic biology and biological diversity, in line with the CBD objectives, regarding the proposed topics for this round of discussion. Taking into account that components, organisms and products resulting from synthetic biology techniques do fall under the scope of the Cartagena Protocol and CBD, the relationship between synthetic biology and biological diversity can be described by the potential direct and indirect risks that these new organisms and components could produce to the conservation and sustainable use of biological diversity. These potential risks should be assessed prior to any introduction to the environment, in a precautionary manner, taking also into account risks to human health and socio-economic considerations, especially with regard to the value of biological diversity to indigenous and local communities. I would also like to echo those who have pointed on the potential damage resulting from organisms, components and products of synthetic biology techniques that must also be addressed through a liability and redress regime.

Best regards,

Sarah
posted on 2015-05-02 01:16 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 6832 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6927]
Dear colleagues
My name is Mohamad Faiz. My field is molecular genetics and I am participating here for the Genetic Modification Advisory Committee of Malaysia.

I have similar concerns on issues in the long list posted by Jim Thomas. Many, if not all, of the less desirable impacts of synbio in Jim's list can also be cause by classical genetic engineering.  From this point of view, synbio can be seen as an accelerated and intensified form of classical genetic engineering.  The provisions of the Cartagena Protocol for dealing with risks  posed by modern biotechnology can be equally applied to synbio products.

For the current  state, it is still feasible to extrapolate what are the effects of synbio products and technologies on existing biodiversity. This will however become more difficult as synbio matures, and more diversified  technologies are brought into the mix. As of now, engineering concepts, computational mathematics etc. are added to increase the complexity and intensity of what synbio can achieve. The side-effect is a concomitant increase in  unpredictability, and with this, an increased requirement for control measures. Thus, attempts to understand the how synbio will affect biodiversity will need to look at all of these three facets.

Besides a more heady mix of technologies, we can also expect to see an explosion in the scope of current synbio products and technologies, given the molecular biologists's penchant to take things down the "massively parallel" path. To stretch one's imagination, releasing an organism with an array of  gene drives that are activated in random combinations will allow it to rapidly evolve and adapt to multiple niches. Thus while the Cartagena protocol is adequate for the time being, we may need to be ready for addressing what synbio has to offer in the near future.

Mohd Faiz
Universiti teknologi MARA, Malaysia
posted on 2015-05-02 03:10 UTC by Mr. Mohamad Faiz Foong Abdullah, Malaysia
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6929]
Dear colleagues,

My name is Jose Jimenez and I am an assistant professor in Synthetic Biology at the University of Surrey in the United Kingdom.

Since there is a specific thread for the definition of SynBio I would like to reflect here about the specific question of how to address the relationship with biodiversity.

I am perfectly aware about the concerns that the impact of SynBio may rise in the society. However, as many said before, I think we should focus in the products and not in the processes. Many colleagues working in long established fields, like Molecular Biology, may argue that the listed goals compiled by Jim Thomas are not exclusive of SynBio and could be achieved without invoking to it. Actually, some of those topics, like biodegradation using either natural (isolated from a different niche) or recombinant organisms, or the resurrection of ancient genes were technically possible and subject of much debate long before the advent of SynBio.

As mentioned previously by other members of the forum (Mr. Regalado among others), the Cartagena protocol already provides a policy to asses effects on biodiversity. In my opinion, all organisms derived from existing ones obtained by SynBio means fall into the LMO category including those hybrid incorporating xeno-chemical components.

Best regards,

Jose Jimenez
posted on 2015-05-02 09:07 UTC by Mr. Jose Jimenez, University of Surrey
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6941]
My name is Mike Paton. I am a policy advisor on microbiology (including LMOs and synthetic biology) in the UK’s principal workplace safety regulator (Health and Safety Executive). I have a scientific background in molecular microbiology, supplemented by many years’ experience as a biosafety regulator. I am pleased to participate in the synthetic biology on-line discussion forum and thank the moderators and other participants for their interesting and important contributions.

Synthetic biology, as illustrated by Paul Freemont and others, comprises a range of approaches and methodologies aimed at developing precision, reproducibility and standardisation within biological systems, which will provide a platform, to develop products (including LMOs, proteins, chemicals, materials) that can realise environmental and health improvements across a range of industries and applications. However, as explained by Jim Thomas and others, there are potential risks associated with such applications as with all new technologies. Many of these risks and benefits coincide with those previously described for modern biotechnology. As indicated by Jim Louter, Kent Redford and others, it’s important that both risks and benefits are considered and given perspective, which can be achieved through risk assessment and where necessary adopting proportionate risk management strategies. 
Similar to the position in the Netherlands, as explained by Boet Glandorf, all synthetic biology activities involving LMOs in the UK, takes place under contained use conditions (ie in laboratories and industrial installations etc). Indeed, I am not aware of any applications as yet to release synthetic biology organisms into the environment. As Boet explains, there is a well-defined risk assessment and authorisation process before such a release could occur. This is supplemented by other regulatory regimes including chemicals, food, feed, medical and veterinary products. Hence there is a mechanism to consider the risks to human health and the environment on a case by case basis.

As pointed out by Mohamad Faiz Foong Abdullah, Caroline Burgeff and others, it is important to recognise that the risk assessment methodology for LMOs may need to be modified to encompass future synthetic biology applications. However, as Hideyuki Shirae, Paul Freemont and others explain, synthetic biology is an extension of modern biotechnology and experience from over 40 years of safe practice and risk assessment is relevant and valuable. This is echoed in the Opinions I and II  provided to the European Commission from their scientific committees on synthetic biology (part 1- definition; and part 2 – risk assessment) , , which also provide some pointers on areas that may need wider consideration. The EU framework requires an assessment of the potential risks to the environment (and to human health) that might arise from using that GMO (either under contained conditions or if released to the environment). These risk assessments require detailed descriptions of the origin, genetic makeup and outward characteristics of the modified organism and any potential interaction with the environment (including plausible pathways linking a characteristic of a modified organism to an impact on biodiversity).  They are the cornerstone of biosafety, and allow the relationship between synbio and biodiversity to be investigated on a case by case basis. This is important because of the potential novelty and complexity of modified organisms offered by synthetic biology.

The overlap between synthetic biology and modern biotechnology is important when considering the relationship with the CBD. As pointed out by Genya Dana, agreement has not been reached on whether synthetic biology is a new and emerging issue for conservation and sustainable use of biodiversity. Further robust analysis is required to inform the relationship between CBD and synthetic biology and should be compared and contrasted with the risk management approach to modern biotechnology. Interestingly, Paul Freemont highlighted recent work on biocontainment strategies (Mandell et al 2015 Nature 518) that effectively incorporated safety by design into LMOs, which will offer additional considerations for risk assessment.

Most participants recognise that LMOs generated by synthetic biology fall or will fall within the CBD. Consequently, Article 8 of the Convention requires all signatories to establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology, at a national level. This is supplemented by the Cartagena and Nagoya Protocols dealing with biosafety and fair & equitable sharing of benefits respectively across national boundaries. There is undoubtedly a need to share practical experience and guidance to facilitate capacity building with regard to modern biotechnology (including synthetic biology), an initiative already started under the Cartagna Protocol. Given these existing provisions and initiatives the existing provisions of CBD and associated protocols appear to provide an adequate framework for balancing the risks and benefits from synthetic biology.

Many thanks
posted on 2015-05-03 10:02 UTC by Mr. Michael Paton, United Kingdom of Great Britain and Northern Ireland
This is a reply to 6941 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6946]
If we discuss the relationship between Synthetic Biology and biological diversity in last consequence we always have to ask how we can protect the existing biodiversity as well as its evolutionary adaptability in future. In doing so, we have to take into account all relevant processes, compounds and organisms.

Some of the organisms derived from the new technologies will have biological characteristics that hardly can be compared with those from existing biodiversity. But gene synthesis can also be used to replace a whole genome or chromosome without obvious changes.  Under these circumstances, impact assessment for biodiversity can only be performed if the process is taken as a starting point. Otherwise it would be impossible to know which organisms are produced and released for real. Therefore it also would be impossible to perform any risk assessment and to monitor any interactions of those organisms with each other and with biodiversity.

Living in the age of 'anthropocene' we have to take into account quickly changing environmental conditions if we want to assess any impact for biodiversity. In this context, we can make use of existing experience with alien species: Once introduced into a new ecosystem, only a few species will persist and even a much smaller percentage will become invasive. But those few species which finally become invasive can pose major threats to biodiversity. All in all the long term consequences of the introduction of alien species are hard to predict.

But there are further uncertainties when it comes to risk assessment of organisms stemming from Synthetic Biology: In most cases, the new genetic information is introduced into the gene pool of species that are already established. Thus the new genetic information might spread much quicker within biodiversity than it is the case with alien species. One consequence: Spontaneous transboundary movements of these organisms might cause significant economic and ecological consequences in countries that are not prepared to take adequate measures.
posted on 2015-05-03 18:35 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 6946 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6947]
First of all, I will like to thank Ryo Kohsaka for moderating this topic.
My name is Jorge-Antonio ROJAS-BELTRAN, I am from the San Simon University (Cochabamba, Bolivia). I am coordinator of the “Agricultural Bio-Nanotech Research Center"
I consider the AHTEG wants inputs to clearly explain to society about synthetic biology (benefits and risks). Among scientists, I think we can easily convince each other about the interest of developing this new technology (I did not read many opinions condemning the technology). However, we must be very aware that it will not be the same when we will discuss with the society about this subject, of which we are only a part. Believe me; it will be hard, especially if we live in a country that is center of origin and biodiversity of many cultivated species.
It is a mistake to assume that society is already convinced about the "benefit" of LMOs and that synthetic biology will be only "a mature stage" of LMOs. LMOs, at least as our society have "assimilated" it, will be “a small affaire” compared to "products" of synthetic biology. We can accept that synthetic biology is an extension of biotechnology, genetic engineering, etc., but we can’t forget that our society understand LMOs, at least in my country, as a specie that has been modified (one or few genes involved), but we can still recognized it as a specie (soybean, corn, cotton, etc.)
For me, the difference between LMOs and "products of synthetic biology" is to be found in the difference between the words modify and create. I cannot imagine the commotion that will be caused in many social sectors when I will say, very enthusiastic: “through synthetic biology we can create life!!! In this perspective, experiences of the debate about LMOs, which is still in force, should be taken into account, in order to do not make the same mistakes. For example, it is not the same to discuss about these technologies in an industrialized country and in a "developing" country, and even less in a country that is center of origin and biodiversity of many species.
Therefore, I will give my opinion on the subject, from the context in which I live: Bolivia, mega diverse country. In which, at this time, the official position of the state about synthetic biology, is not authorize commercial release of the synthetic biology "products” until it has procedures and international regulatory frameworks to ensure the protection of the life systems of mother earth.
When we was debating about LMOs, which were "for", we argued that a good decision emerges from the evaluation of the relationship between risk / benefit. Then we argued that the LMOs had many more benefits than risks (among them was that there would be no anymore hunger in the world). I will apply this same tool to analyze the relationship between synthetic biology and biological diversity, considering relevant in the context of the three main objectives of the convention proposed by the moderator, namely:
1. The conservation of biological diversity
2. The sustainable use of the components of biological diversity
3. The fair and equitable sharing of the benefits Arising out of the utilization of genetic resources

Jim Thomas (6832) basically talk about the risks of synthetic biology on the three points proposed by the moderator. Now I will try to refute the arguments of Jim (Jim, is not personal), simulating a debate that I will inevitably have to face in the future.
1. The conservation of biological diversity. On this point, perhaps an original contribution of synthetic biology, that I could argue to defend it, maybe that we can "revive" extinct species, or perhaps say: no matter if an endangered species become extinct because we have the technology to it back to life. In contrast, we have all the arguments put forward by Jim ... ¿How the society will be evaluate the benefit / risk  on this point?

2. The sustainable use of the components of biological diversity. Here I cannot found a strong beneficial argument, perhaps I could use the same argument advanced for point 1. Instead, here comes immediately to my mind that the interest on the conservation and sustainable use of agricultural biodiversity, decreased dramatically when we developed the technology to make LMOs. Just look how they are surviving at the present international centers dependents of a so-called IBPGR. I fear that the interest will fall even more with synthetic biology. By obtaining LMOs, it was no longer necessary to have individuals to make crosses. With synthetic biology is likely that only at the beginning, we will need “original” genetic material only for "inspiration," then, even it will be no necessary.

3. The fair and equitable sharing of the benefits arising out of the utilization of genetic resources. Here I am definitely dead. Bolivia is the center of origin and diversity of many crops. However, until now, after all signed agreements, I do not know any case where the country or farmers have been benefited with the utilization of genetic resources. Will change this situation with synthetic biology?
Taken all into account the three reference points given by moderator, regarding the relationship between synthetic biology and biological diversity, I do not see many arguments that I can use to convince public opinion on the benefits of synthetic biology. Obviously, this situation is different for an industrialized country, where the economic benefit of this technology is enormous and more evident.
Some colleagues think that everything is solved by CBD. I disagree, because even the issue of LMOs has not been resolved yet with the CBD. The detail is that the CBD transfer many operational responsibilities to the countries and many developing countries cannot implement this responsibilities for lack of means and resources. I don’t think that this situation will change with synthetic biology.
In conclusion, we have to think and propose more arguments in favor of synthetic biology for the points proposed by the moderator.
posted on 2015-05-03 20:01 UTC by Mr. Jorge Antonio Rojas Beltrán, Bolivia (Plurinational State of)
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6955]
Dear Colleagues,

I am Dr Gulay Mann, a principal research scientist at the DSTO.

I would like to start the discussion by providing a historical background. The first use of the phrase “synthetic biology” dates back to the very early 1900’s when Stéphane Leduc, a French biologist, used it in his papers titled “Théorie physico-chimique de la vie et générations spontanées” (Leduc, 1910) and “La Biologie Synthétique (Leduc, 1912). However, Leduc’s definition of synthetic biology encompassed physical forces governing life. Use of the phrase “synthetic biology” as we know it now was first popularised in 1974 when Wacław Szybalski described a field where engineering principles can be fully applied to biology: “Up to now we are working on the descriptive phase of molecular biology. ... But the real challenge will start when we enter the synthetic biology phase ... We will then devise new control elements and add these new modules to the existing genomes or build up wholly new genomes.”… (Wacław Szybalski, 1974).

Since then, synthetic biology has progressed to the point that today it is a cutting edge field attracting significant attention from both the research community and the broader community.

The emergence of synthetic biology was driven by four major motivations. The first was to attempt to understand complex biological systems by taking them apart, studying their individual parts and then trying to rebuild them. The second was to enable living organisms to better perform useful roles by manipulating them at the molecular level. Given the appropriate selective pressures, this process would naturally take place over a long period of time (natural selection); synthetic biology approaches can significantly expedite this process (Serrano 2007). Third is to generate standardized building blocks that can be used to build functional biological systems to test our current understanding. The fourth motivation is the potential use of synthetic biology as a technology platform for specific useful purposes, including information processing, energy and food production, environmental sensors, etc.

Whilst the emergence of synthetic biology was driven by these motivations, the progress of the field was facilitated by two key technologies: (1) Automated DNA synthesis, a key enabling technology required to build code for the various biological devices which allowed the field to develop beyond conventional biotechnology. Customised DNA synthesis allows the construction of genetic elements and can be tailored to carry out specific existing and novel functions. (2) Automated DNA sequencing, which allows synthetic biologists to confirm that the sequences they have constructed are correct.

In my view, the synthetic biology is not a science discipline nor is it a new science per se, but it is a collection of tools and techniques used across a range of technologies, for both basic and applied research. It builds on the advances in molecular biology and biotechnology; however; the key element that sets apart synthetic biology from other more conventional approaches is the focus on standardization and abstraction of modular biological components (minimal parts of enzymes, genetic circuits, and reporter protein coding DNA etc.). As the individual smaller biological components are studied, tested and understood at a sufficient level, then they can be assembled into larger biological devices that can achieve to solve a particular problem.

One of the most significant aspects of SB is to build tools that claim to make biology easier to engineer. Fuelled by the reductionist approach synthetic biologists became very good at pulling biological systems apart to study their individual components, however understanding of how these individual parts go back together is lagging behind because of the complexity of biological organisms and the environments they must adapt. Re-building the biological systems that carry out specific functions provides a rigorous test of our understanding of the system under study so is not merely an engineering objective, it also generates new knowledge.

The latter approach of rebuilding biological systems can benefit from a community that works together to design, re-build and test various biological systems and share their results in an open-source platform. The international Genetically Engineered Machines (iGEM) competition (http://igem.org/Main_Page) is an attempt to develop such a community. It not only helps synthetic biology to grow rapidly but also enables systematic engineering of biology while supporting development of relevant tools in an open-source platform.

Given that synthetic biology is made up of tools and techniques from a wide range of scientific disciplines and it is an approach to making biology easier to engineer, the biosafety assessments, rules and regulations needs to cover the applications and the products achieved so far. With this view in mind, the suggestion of a case by case, science-based risk-assessment of synthetic biology applications to identify actual risks to biodiversity is valid.

The Cartagena Protocol on Biosafety, the safety rules/regulations relating to GMOs/LMOs covers the synthetic biology applications so far.

However, the rapid progresses have been made by the SB approaches make it valid that we need to revisit our discussions at regular intervals.

Leduc, S. Théorie physico-chimique de la vie et générations spontanées. Vol. 1. Poinat, (1910).
Leduc, S. La biologie synthétique. Vol. 2. Paris: A. Poinat, (1912).
Serrano, L. Synthetic biology: promises and challenges. Mol. Syst. Biol. 3, 158 (2007).

Regards,
Gulay
posted on 2015-05-04 00:02 UTC by Ms. Gulay Mann, Defence Science and Technology Organistaion
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6961]
Dear participants,
I’m  Dr Lázaro Regalado from Cuba, National Center on Biosafety, Ministry of Science, Technology and Environment.
I would like to thank Ryo Kohsaka for moderating this topic in the online forum on Synthetic Biology.

Topic 1: How to address the relationship between synthetic biology and biological diversity.

¨Under the Convention ¨biotechnology¨ is defined as “...any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”. Synthetic biology falls within the scope of this broad definition. ¨

On the other hand we should take into account the preamble of the Convention on Biodiversity:
¨Concerned that biological diversity is being significantly reduced by certain human activities

¨Noting also that where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.¨

¨Noting that, ultimately, the conservation and sustainable use of biological diversity will strengthen friendly relations among States and contribute to peace for humankind,¨


I agree with Dr Kok-Gan Chan from the University of Malaya in Malaysia when he said …. ¨it is foreseeable that synthetic biology will affect genetic, species and ecosystems. But whether it has an impact on local and global scales, that depends on the type of LMOs, its products or components¨

In this regard and in a general view I think that, is useful to apply principles such as:
- The principle or precautionary approach ( Rio Declaration of 1992)
- The principles of licensing and inspection.
- The principles of "step by step" and "case by case"
- The principle of traceability.

• Articles 15 and 16 of the Protocol are basically pertinent.

In principle, in order to protect the environment, the challenges constituted by their potential for damage to biodiversity and human health should be subjected to risk assessments from the very beginning of the research design itself to make decisions at early stage, as a prerequisite for approval regardless of their intended peaceful use, and should continue to have provided an adequate risks management at a later stage if be accepted. ¨Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, taking also into account risks to human health…..¨ (Cartagena Protocol Art 16)

The first part of these considerations applies to:
• The conservation of biological diversity
• The sustainable use of the components of biological diversity

The last issue suggested by the moderator Ryo Kohsaka:
• The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

As defined by the Convention "Genetic resources" means genetic material of actual or potential value.

While this issue might not cover all aspects of Synthetic Biology, I think that the most important is the fair equitable sharing of the benefits that also applies to SB and In this regard I would like to draw the attention to the appeal of Mr. Matthew Legge who pointed out:

¨It is clear to us that the profit motive does not necessarily work to support the goal of the preservation of biological diversity or the fair sharing of costs and benefits between developed and developing countries. At present, there appears to be a concentration of decision making power and control related to synthetic biology in the hands of a limited number of stakeholders, most of whom are driven primarily by a profit motive and who do not bring an ecological perspective to their decisions.¨

Synthetic biology may be used for advanced medical interventions but also could have unintended impacts on health and biodiversity. (Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82 118 pages.)

While having developed into one of the most dynamic fields of the life sciences, synthetic biology may pose potential risks to the environment and human health. Based on current national and international risk assessment methods …… management strategies to guide future research in synthetic biology with necessary amendments, including the establishment of regulations with a core of safety assessment, synthetic biology-specific good laboratory practice guidelines, and arguments for the reinforcement of internal regulation at the institution level and more active public outreach efforts for biosafety. (Assessment and management of biosafety in synthetic biology. Zhengjun Guan1,2, Lei Pei3, Markus Schmidt3, Wei Wei1,* Biodiversity Science 2012, 20 (2): 138–150 http: //http://www.biodiversity-science.net )

Respectfully,
Dr Regalado
posted on 2015-05-04 05:13 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 6771 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6963]
The following is found as a double-spaced file in the attachment CBD final FB SB-1 & BD.docx:

Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6760]


I express my appreciation to Ryo Kohsaka for welcoming me to this discussion and to Ms. María Andrea Orjuela Restrepo for moderating this forum.

My name is Fred Bass.  I serve as an associate to the Board of the Canadian Friends (Quaker) Service Committee, with my focus directed to synthetic biology.  My approach is from an epidemiological/ecological/ethical perspective.  My background is that of a physician/epidemiologist who devoted more than four decades to tobacco control, helping to translate research into practice.  My ethics are based on the Quaker values of simplicity, peace, integrity, community, equality and care for creation.

The (three) objectives of the Convention on Biological Diversity (CBD) are: 
the conservation of biological diversity (diversity within species, between species and of ecosystems);  the sustainable use of its components; and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources…   

In addressing the relationship between synthetic biology and biological diversity, we should consider two distinct threads:  1) making good the unprecedented, challenging potential of synthetic biology; and 2) addressing the increasingly desperate situation of the world’s ecosystems and its biota, particularly its people.  Work tends to focus either on 1) or 2).  I think the task of our discussion group is to focus on both.
If mass extinction were not occurring now, there would be no CBD.  But species are rapidly disappearing and we need to respond promptly and appropriately.  As others in this discussion have commented, the global, ecological and social issues are problems for all technologies, not just synthetic biology.  Yet this is no reason to ignore such issues.  Synthetic biology has particular relevance since it deals with the core of living systems, the genome.  For our group to work on both threads noted in the previous paragraph, we will require wisdom, compassion, technical understanding and technical proficiency.  Of relevance, Albert Einstein is quoted,
Concern for man and his fate must always form the chief interest of all technical endeavours. Never forget this in the midst of your diagrams and equations.

Human’s implementation of technologies over the past several centuries, aided by our economic system and our consumptive behaviour, has caused serious ecological disruption—the current mass extinction (see UNEP’s Millennium Ecosystem Assessment) and its huge loss of biodiversity.  As we develop synthetic biology, hopefully, we will do something different.
One aspect of synthetic biology and biological diversity concerns the risk-assessment of new genomes.  In the case of natural genomes (those of biological diversity), risk is minimal, because the genome has been modified over a long period of time by evolution and by its processes of natural selection.  In the case of synthetic genomes, their life history is instantaneous and thus natural selection inoperative.  It seems to me that even a century’s experience with synthetic modification of genes might not be enough to assure that our human-crafted management of risk matches that of nature.   For this reason, I would recommend that at least one evolutionary biologist who is well versed in genetics be recruited to the AHTEG. 
In evaluating any intervention/treatment manufactured by humans, there is always the possibility of a catastrophic consequence of very low probability, so low as to be unprecedented.  How best to deal with such contingencies regarding synthetic biology is a major challenge to decision-making under uncertainty.  Dana et al’s statement seems reasonable: “no one yet understands the risks that synthetic organisms pose to the environment, what kinds of information are needed to support rigorous assessments, or who should collect such data”.   To accept risks that are only estimated theoretically, rather than measured in actual frequency, is more an act of faith than of evidence-based practice.
The CBD should guide prudent development of this technology, by carefully attending to ecological and social values and by seeking to avoid unacceptable damage to species, people and ecosystems.  Such contribution would be of the highest human value.
posted on 2015-05-04 05:27 UTC by Dr Frederic Bass, self-employed
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6972]
My name is Anne Mitchell.  I am an Associate Member of the Canadian Friends Service Committee with an interest in biotechnologies.  I am also the chair of the Biotechnology Reference Group of the Canadian Council of Churches.  I have over 40 years experience in the fields of international development, human rights and the environment.  Thank you for the opportunity to participate in this process.

The proponents of synthetic biology offer many promises of the technology in the areas of fuels, foods and manufactured goods.   The critics of synthetic biology  have legitimate concerns about how synthetic biology will impact, particularly on biodiversity.   This appears to be the only international forum where synthetic biology is being considered.    Most of the comments so far on this forum seem to be assuming that the promises of synthetic biology far outweigh the perils and that the main point of contention in this discussion is to define ‘synthetic biology’.   It is, however, important to address the ecological dimension of synthetic biology and its potential impacts on biodiversity; the social dimension and the need for the equitable distribution of benefits to meet the needs of the vulnerable; and to also address the value of this technology as compared to human wisdom and humility.
Perhaps it is necessary to go back a step and consider what kind of frameworks should be in place as this the synthetic biology industry grows.   I would like to reiterate the principles necessary for the effective assessment and oversight of this emerging field, as articulated in the 2012 document signed on to by a broad coalition of civil society groups, social movements, local and indigenous communities, public interest, scientific, human rights, religious and labour organizations concerned about the various aspects of synthetic biology’s human health, environmental, social, economic, ethical and other impacts.   The Biotechnology Reference Group of the Canadian Council of Churches is one of the signatories of this 2012 document.    The first principle is to employ the precautionary principle.   This is crucial because since the environmental release of synthetic biological organisms is likely to impact indigenous organisms in unforeseen ways and since synthetic biological organisms will not respect national boundaries.   These are compelling reasons to develop a worldwide regulatory framework.   This framework should take into consideration the interests of States, indigenous peoples, synthetic biology companies, researchers, hobbyists and the general public.  Biosafety should not be left up to the synthetic biology companies or individual hobbyists alone, because of their obvious conflict of interest.  States should play an active role in ensuring the precautionary principle is employed.
posted on 2015-05-04 13:43 UTC by Ms. Anne Mitchell, Retired
This is a reply to 6972 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6975]
This is in reply to Miss Mitchells post.
As far as I understood the Agenda, the socioeconomic and ethic questions will be discussed later, or am I wrong?
I totally agree with your statement but how can you discuss the risks of synthetic biological organisms if you do not have a valid definition of such an organism?
posted on 2015-05-04 14:07 UTC by Mr. Frank Hartung, Germany
This is a reply to 6975 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6989]
Dear All,
this is message from modarator of this sesssion,  Ryo Kohsaka. Thank you all for expressing your views on the relationship between synthetic biology and biodiversity.

Could we have a round of brief comments (2-5 lines) on "ways to address the relationship" of the two?  You could repeat what you have said but in a brief and concise manner.  The topic will need to move on to other points soon. 

Discussions so far show how diverse the scope and interpretaion of relationships of the two concepts are (both positive and negative).  Some expressed that existing mechanism to the issue to be useful, while others propose new or different approaches to address the relationship.
posted on 2015-05-04 15:32 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6995]
Dear colleagues,

Synthetic Biology is a technique potentially more efficient which has predictive processes and one of its sources could be biodiversity, this technique should be based on sustainable use and conservation; that is why the risk assessment should be based on case by case assessment.

Best regards to all.

Noris.
posted on 2015-05-04 17:23 UTC by Ms. Noris Dalia Calderon, Mexico
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#6998]
I am Dr. Louise Horsfall (University of Edinburgh), selected to represent the European Federation of Biotechnology (EFB - http://www.efb-central.org) and an elected chair of its Bioengineering and Bioprocessing section.

As the moderator has now asked for a round of brief comments on ways to address the relationship between synthetic biology and biological diversity, I will summarise the important points as follows:

Both risks and benefits should be considered when proposing ways to address the relationship between synthetic biology and biological diversity. While risk assessment methodology may need adjustment in future for continued compatibility with synthetic biology advances, current risk assessment practices are comprehensive for the technology we have now. This mechanism already serves to consider the risks to health and the environment on a case by case basis with CBD and associated protocols providing a framework to achieve this balance.
posted on 2015-05-04 19:40 UTC by Dr Louise Horsfall, University of Edinburgh
This is a reply to 6998 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7002]
Dear Noris and  Louise (if I may) #6995 and #6998,

thank you for your brief comments.    Let's keep this up.
posted on 2015-05-04 21:20 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 6818 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7003]
My name is Phil Macdonald and until recently I lead a group of risk assessors responsible for conducting risk assessments on LM plants intended for environmental release. I am now responsible for coordinating research in plant health and biotechnology related areas. I agree with both Uwe and Piet that the simultaneous multi topic  approach is confusing. I also agree with Piet that until participants have at least a common understanding of the scope of what is considered as synthetic biology and where it may realistically diverge from the more familiar tools employed for the production of LMOs, it will be difficult to achieve the most constructive result.

Phil Macdonald
posted on 2015-05-04 21:31 UTC by Mr. Phil Macdonald, Canada
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7004]
Many thanks for the foregoing comments, I note the moderators request for brief summations and will do so at the end of this intervention but wanted to first to respond with points of clarifications to a couple of  point that have been raised and i think are erroneous or incomplete.

Both Mohammed Faiz and Jose Jiminez (and perhaps others) responded to my post in which i set out a series of concerning impacts of Synthetic biology on the goals of the convention (as requested by our moderator)  - In an otherwise very considered response Dr Faiz claimed that  “many” of these impacts could also have been caused by classical genetic engineering and Dr Jiminez  also said that he saw such outcomes as ‘not exclusive’ to Synthetic Biology.

I think they are only partly right. There are of course individual applications that were being pursued through ‘classical’ techniques prior to the emergence of Syntehtic Biology as a platform (e.g. work on cellulases) but the specific power and significance of Synthetic Biology is that it enables a speed, efficiency and level of novelty in re-engineering genetic systems that would have  taken much slow painstaking work beforehand - in that sense applied uses of modern biotechnology will become more common, more powerful and appear more quickly than when the only available  techniques were simpler and slower. It is that acceleration and increased intensity  of biotechnological activity that makes the emergence of Synthetic Biology significant .

To make an analogy: it was possible to sample music before the advent of digital recording (using cut and paste splicing of magnetic tapes) but the advent of  digital tools created an entirely new world of electronic and sampled music as well as new ways for listening and interacting with music and also created entirely new genres (as well as new issues around theft of cultural material). So in a similar way the partly digital tools of  Synthetic Biology are now accelerating and changing the landscape for biotechnological manipulation of nature for industrial purposes and we need to pay attention to the step change in production. To give just one example of how this step change is playing out - biotechnology companies had previously  attempted to produce natural product molecules such as vanillin through recombinant DNA and cell cultures but with little success. Now, in this early era of Synthetic Biology,  we are seeing a proliferation of organisms engineered to produce not just vanillin but reseveratrol, patchouli, saffron, nootkatone, sandalwood, artemisinin, rose oil, vetiver etc etc. That is a significant real world shift - It potentially impacts the  millions of farmers and processors that grow 200-250 commercially valuable flavor and fragrance compounds on at least a quarter of a million hectares of land worldwide and the cultural and agronomic systems that they are part of. if that shift occurs (and it may only be limited- its too early to tell) it will be because of the existence of Synthetic biology tools, techniques and processes.

In a few comments (e.g. by Jim Louter and Lazaro Regalado) there has been a presumption or reference to Risk Assesment which seems to have in mind the sort of narrow, technical, case-by case scientific hazard-characterization approach reflected under the Cartegena protocol or in some Environmental Impact assessments. However a narrow risk assessment would fail to capture the cumulative shift   and wider economic and societal changes that proceed from these technologies - just as narrow technical evaluation of the toxicity hazards of corn ethanol or jatropha oil would fail to tell you anything about the impact on food security, land rights or cultural practice  that upscaling of ethanol and biodesel use and production has wrought. Its important to look beyond the direct impacts - sometimes the ‘indirect impacts’ are the most powerful nd significant.  What we should have in mind is not just ‘risk assessment’ but broader Technology Impact assessment’ able to assess the economic, social and indirect impacts with equal weight to the immediately obvious topics of toxicity, biosafety etc. To take this wider frame is not only appropriate and responsible but in the case of Syn Bio is in fact mandated by the terms of the Convention on Biological Diversity which in Article 8(g) requires parties to “establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.” (Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82, 118 pages.)

Please note that this requirement covers not only environmental release (thats the direct impacts)  but also (separately) the ‘use’ of living modified organisms resulting from biotechnology  which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. The example of biotechnologically-produced flavors and fragrances is a perfect example of this. The ‘use’ is already there, there is increasing evidence that  this ‘use’ is ‘likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity,’  - namely indirectly by changes in the economy. It therefore falls to parties to “establish or maintain means to regulate, manage or control the risks associated with the use”.

  To date the Convention has developed means to regulate manage or control direct risks to conservation and biological diversity arising from products of modern biotechnology being released into the environment (The cartegena protocol). It has also developed means to regulate manage or control risks to the fair and equitable sharing of benefits arising from biotechnology (the Nagoya protocol). But it has so far failed to develop  means to regulate, manage or control indirect risks  to the conservation and sustainable use of biological diversity arising from use LMO’s arising from  Syntehtic Biology techniques, tools and products (e.g. changes in land use, loss of natural product production systems, issues associated with feedstock production)

So to answer the request for a summation on HOW to address the relationship between Synthetic Biology and Biological Diversity.:

In order to address  the relationship between synthetic biology and biological diversity, it is necessary for parties to fulfill the terms of Article 8(g) providing means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from Synthetic Biology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.” 

The Cartegena protocol provides some elements of addressing the direct risks related to release and use (biosafety) of organisms produced through techniques of synthetic Biology  although there is a need to expand the definition of an LMO and to update some of the provisions of the protocol to properly encompass ongoing developments.

The Nagoya protocol could provide the means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from synthetic biology as they relate to fair and equitable sharing of benefits - however that would require an updating of the meaning of a genetic resource and other changes within the protocol to make it fit the digital character of synthetic biology developments and to account for products and parts.

However, most worryingly,  the CBD and its parties  currently have no means to regulate, manage or control the direct and indirect risks to SUSTAINABLE USE of biodiversity associated with the use (and release) of living modified organisms resulting from synthetic Biology (including questions of feedstocks, replacements of natural products, economic changes and land use changes stemming rom the bioeconomy etc).

In our view the CBD should prioritize this lack - perhaps by beginning a programme of work to undertake Technology Impact Assement for techniques, components, organisms and products of synthetic biology and other modern biotechnologies. It may decide to develop a protocol, agreement or decision providing the ‘means to regulate, manage or control the direct and indirect risks that the use (and release) of Synthetic Biology organisms poses to the conservation and  sustainable use of biodiversity. Its remit should include developing tools and processes including  Technology Impact Assesment that would be used by parties to fulfill their obligations under 8g.


With best wishes

Jim Thomas

ETC Group
posted on 2015-05-04 21:48 UTC by Mr. Jim Thomas, ETC Group
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7009]
I would address the relationship in the following way:
1) Are products unable to replicate and reproduce, there is no relationship. No risk
2) If products of synthetic biology are able to replicate and reproduce, but  they are for contained use only, there is a limited (accidental) relationship. Low risk
3)  If replication competent products are released, a relationship between the products and biological diversity has to be considered.  Potentially high risk
Products falling in case 3 must carefully be validated. Here we have two levels:
Level 1: products are inspired and similar to nature. Here conventional risk assessment strategies apply.
Level 2: Novel unnatural products are designed. Here conventional risk assessment strategies might fail. These products should be limited for contained use until sufficient information concerning their environmental potential has been collected.
posted on 2015-05-05 07:39 UTC by Mr. Uwe Sonnewald, Germany
This is a reply to 7009 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7011]
I agree with Uwe Sonnewalds post.
As I mentioned earlier, the first indicator should be if the synthetic biology product is replication competent and/or released. In this case SB is clearly related to biological diversity harboring a potential positive or negative impact on it.
If such an SB product is "natural" CBD-guidelines would be sufficient and applicable. I do not see the point of other comments that speed or amount in which SB products arise is a matter of concern for biological diversity as long as these are contained. This seems to me a rather ethical point and as well as the risk of catastrophic events resulting from contained used scenarios should be discussed separately.
If such an SB product is "unnatural" (I am not happy with this terms, anyone know better ones?) the CBD guidelines might not be sufficient and even not applicable.
posted on 2015-05-05 09:13 UTC by Mr. Frank Hartung, Germany
This is a reply to 7011 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7013]
Thank you for being to the point. I also understand that you would need  more lines to respond to others but please try to be concise.   You could refer to external sources for longer texts.
posted on 2015-05-05 11:06 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 7009 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7015]
I would like to agree to Uwe Sonnewald and Frank Hartung on the point that only replication competent products of synthetic biology (that are released into the environment) should be able to pose a risk to biodiversity. For the moment these are covered by the LMO definition of the Cartagena protocol. However, we should check in regular intervals whether this definition still applies to all synthetic biology organisms.
I also do agree with Jose Jimenez that the goals raised by Jim Thomas and others in this forum are valid, but not exclusive of synthetic biology. For me, the concerns they refer to are more likely general topics related to globalization and biotechnology.
I would also like to re-emphasize that we should concentrate on the product and not on the process involved. If a synthetic biology organism poses a risk to biodiversity, this risk would clearly lie in the characteristics of the organism (e.g. invasiveness, ability for horizontal gene transfer, risk for human beings or the environment), regardless of the techniques used to produce the organism.
posted on 2015-05-05 12:00 UTC by Ms. Swantje Strassheim, Germany
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7016]
POSTED ON BEHALF OF RICARDA STEINBRECHER

----

Dear colleagues,

My Name is Ricarda Steinbrecher, with the Federation of German Scientists.

It has been a highly interesting discussion, thank you to everyone. In my view, the different contributions reflect well how multi-layered and multi-faceted the relationship and contact points between synthetic biology and biological diversity are, and the different takes on this.

As SB is based on and derived from biological systems, utilises and builds on biological (including genetic) resources and pathways, and as it functions (largely) within biological systems, parameters and constraints – there are many intersections and openings for relationships with biodiversity.

Focus should be given to those areas and relationships that are of concern – within the context of the CBD - and where negative impact can arise to biological diversity, human health, small scale farming systems and their contribution to biological diversity and ecosystem function, food security, livelihoods and related socioeconomic considerations, indigenous peoples and local communities, including cultural aspects. Some of these areas of concern have been pointed out by others in this Forum, including Ossama AbdelKawy, Marina Rosales Benites de Franco and Sarah Agapito-Tenfen.

I agree, that we need an operational definition, though I do not regard it as a prerequisite for deliberations on the other topics currently in progress. I will send a response and comments on topics 2 and 3 later. Concerning how to address the relationship between SB and biological diversity, I suggest to first identify the relationships and inter-linkages where there is concern and potential for negative impacts (direct and indirect) – ie focusing on the risk relationship. This will then help in further steps and topics down the line.

The following is an attempt to have a first overview of aspects and contact points between SB and biological diversity with potential for negative impacts (divided into sections I-VI):

(I) In a systematic, multilayered and interrelated approach, relationships of concern addressed should include:


(1) Direct contact through intentional or unintentional release into the environment (water, land, air) of:

-  organisms resulting from synthetic biology
-  *compounds resulting from synthetic biology and
-  *products resulting from synthetic biology

Some of these may be new compounds and products not previously present in or released into the environment or not in this quantity, purity or combination.  The problems arising from mass production and mass release is part of this concern (we recall for example the unforeseen and increasing burden and negative impact of plastic, particularly when it breaks down into very small particles or is already produced as micro-particles, but also bags and bottles etc on aquatic life). Hence organisms, compounds and products resulting from SB may occur and impact:

a) in their intended and well characterised manifestation/form
b) in unintended / unexpected form (including precursors)
c) in altered form: eg breakdown products (in numerous cases breakdown products are more harmful than the original compound/substrate, eg some fire-retardants); shortened or unexpected dsRNAs; genetic or synbio elements and compounds integrated by other organisms; alterations occurring through interaction with organisms, compounds and conditions present in the environment.

**Invasive Alien Species:** Invasive alien species are already of serious concern to the CBD for their impacts on biodiversity in many parts of the world. There is a very real risk that organisms produced through the use of synthetic biology techniques could become invasive alien species, posing a completely new level of risk to biodiversity, especially if there are no comparators to use to assess their impacts (see re comparators below). Alien Invasive Species in this context refers to any organisms, plant, animal, fungus or microorganism.

* Here I would like to respond to Uwe Sonnewald, who stated: “we can sub-divide the applications in living and non-living systems. For biodiversity only living systems count”.  I am not sure I understood correctly – thus apologies if I am drawing the wrong conclusions – this sounds though like a suggestion to exclude ‘compounds’ and ‘products’ from what should be looked at? Yet compounds and products (especially when looking at pesticides and for example the impacts of endocrine disruptors) can cause serious and irrevocable harm to species and biological diversity and whole ecosystems. Double stranded RNA produced through SB on a mass scale and, for example, used as an ingredient in pesticide formulations and applied widely - this could alter the epigenetics not only of the “pests” present at the area of spraying/release, but affect non-target organisms, enter the food-net and may even spread due to a number of different response and multiplication /enhancement systems. We may have experts on RNAi on this Forum, who could help on this with their input.


(2) Direct contact (either intended or unintended) by/between humans and organisms, compounds and products resulting from synthetic biology, either in the open environment or at the workplace, with any of the permutations detailed above under (1).


(3) Indirect impact: Feedstock requirements – and the need for full life cycle analysis

E.g. the requirements for large scale production systems with contained use applications of SB microorganisms, including algae, or SB processing aids. Feedstocks are thought likely to be largely made up of carbohydrates (eg sugars/starch/cellulose) which may be sourced eg from sugar cane, sugar beet, corn, tree plantations, etc., which may be LMOs or not. Their large scale production has been and/or may be linked to:

a) land issues: land rights and land use change
b) water issues
c) problematic use of chemicals (eg pesticides) and chemical pollution, detrimental to biological diversity, ecosystem function and human health
d) working conditions issues
e) food security/sovereignty (where people are surrounded by sugarcane plantations their access to food and land for food may well be diminished)


(4) Genetic resources, including fair and equitable sharing of the benefits: this area has been pointed out as one in need of addressing early on by Ryo Kohsaka in his helpful introductory remarks, then addressed again by José Leonardo Bocanegra Silva, Lim Li Ching, Jim Thomas, Caroline Burgeff, and Ossama AbdelKawy.

It has been brought to my attention that there is an additional aspect to genetic resources (other than fair and equitable sharing of benefits) that requires addressing, which is that of “loss of genetic resources”, especially agricultural genetic resources, as a consequence of production cycles of SB products through SB organisms: 
Where a technology requires the production of feedstocks, there are implications for biological diversity, but also for agricultural biodiversity and local food security, since where there is land use change or/and where people are driven off or otherwise leaving the land, their local crops and knowledge are also displaced and often lost.


(5) Replacement of natural products and

a) impact on livelihoods
b) impact on small farming systems (see point 6).


(6) Impacts on small farming systems and their contribution to biological biodiversity, maintenance of ecosystems, micro-climate and water capture.

Smallscale agriculture still feeds the majority of the human population. In addition to this, it is also clear that successful smallscale farming systems that do not or cannot rely on the use of chemicals, whether fertilisers or pesticides, are vital for maintaining biodiversity and agricultural biodiversity in situ. Increasingly, agroecological practices, which can include smallscale organic, permaculture and biodynamic systems are recognised as the most successful ways to maintain soils, their quality and health, to prevent soil degradation and soil erosion and also to protect and regenerate water resources. They are also important to maintaining and improving beneficial local micro-climates.


(7) Impacts on indigenous peoples and local communities, including also cultural aspects.
Impacts may arise eg. through contamination, loss, or change of biological diversity (including due to compounds and products); loss of land to eg: sugar production as feedstock for synthetic organisms; change in the meaning and utilisation of genetic resources; the changing relationship between human beings and the biosphere exemplified by the application of the engineering metaphor to life; etc.


(8) Synergistic, cumulative and combinatorial effects

Apart from the potential impacts of particular aspects or manifestations of synthetic biology, there are the unknown and often impossible to predict impacts of interactions between different aspects/elements/manifestations involved. Synergistic, cumulative and combinatorial effects have been discussed in the context of environmental release of LMOs as well as stacked gene events, but also in the context of pharmaceutical compounds and manmade chemicals present in the food chain. It is a known fact that if a substance A is safe to consume (or to apply) at a certain level, and so is a substance B, this does not mean that A and B in combination would be safe. Indeed, on occasions, such combinations have been shown to be toxic.


(II) Liability and Redress

It should be assured that damage arising from organisms, components and products resulting from synthetic biology techniques is addressed through a liability and redress regime – a point already raised by Lim Li Ching from TWN.


(III) Another area of concern is that of “contained use”, the concept of functional and effective separation of organisms from the environment. This has proven to be a flawed concept. Experience shows that so-called contained use systems and facilities are mostly leaky systems. This applies both to physical installations of research and industrial facilities on one hand and to genetically engineered ‘contained use’ concepts such as Terminator-type technologies (V-GURTs) and engineered ‘unfitness’ to fail to survive outside conditions. Organisms, have a tendency to adapt and evolve in order to survive and reproduce, especially micro-organisms, which often exchange information through horizontal gene transfer. And industrial facilities are not proof against human error, system failures, material breakage and extreme environmental conditions and events. Given the quantity and often new qualities and makeup of organisms, compounds and products resulting from synthetic biology, rigorous risk assessment encompassing all aspects (see section I above) should be performed for all applications, irrespective of whether intended for contained use or not. It should always be recalled that one escape could potentially be catastrophic and irreversible, even if the likelihood of it occurring is extremely low. (see also Taleb et al. 2004).


(IV) In this context I would like to draw attention to the need of strict application of the precautionary principle, as recently discussed in Taleb et al. (2014), who for example state:  
“The precautionary principle (PP) states that if an action or policy has a suspected risk of causing severe harm to the public domain (affecting general health or the environment globally), the action should not be taken in the absence of scientific near-certainty about its safety. Under these conditions, the burden of proof about absence of harm falls on those proposing an action, not those opposing it.”


(V) I found Rosales Benites de Franco’s and Kent H. Redford’s reference to the various levels of biodiversity that require addressing (consisting “at least of genetic, species and ecosystem components”) worth while exploring further and wonder whether their approach might be related in some way to what I find problematic with the “precision” concept and the assumption of certainty. With that I mean:

In view of the assertions that genetic engineering and synthetic biology are becoming ever more precise, and the assumption derived from that is that the results will therefore be more predictable/stable/safe, it would also be of importance to address this concept of “precision”. In particular we need to examine to which extent this “precision” can reliably be extrapolated from the minute molecular level, such as a specific genetic sequence alteration, to the cellular and organism level and from thence to the macro level of ecosystems. We would suggest that such an extrapolation is false and holds danger. This assumption of precision and hence of predictability constitutes a false perception of the relationship between synthetic biology and biological diversity and ecosystems.

Knowledge & precision at the level of nucleotides is only the bottom layer.

What is missing is any contextualisation into:
• the genome
• the epigenetic landscape
• the organism
• the ecosystems
• the socio-economic conditions that differ around the world
posted on 2015-05-05 13:09 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7021]
RE how to address the relationship between synthetic biology and biodiversity: CBD cannot look narrowly at the biosafety concerns resulting from potential release but must address the relationship more fully to include indirect impacts. A codirector of Biofuelwatch I am aware that there is a large sector of research and development aimed at developing synthetic microorganisms to break down plant biomass for biofuels and chemicals. The impacts on biodiversity from an environmental release could be very serious, but even more immediately concerning is the impact of supplying vast quantities of biomass feedstock for these processes.  I have submitted information to the secretariat as part of this process already, including examples from mounting peer reviewed literature demonstrating those impacts - deforestation, biodiversity losses, water and soil degradation, displacement of food production, land grabs and speculative investment in land etc.  These are seriously problematic even at the current scale of bioenergy production and cannot be ignored if we are serious about addressing the relationship between synthetic biology and biodiversity. CBD article 8g explicitly requests parties to act to regulate, manage or control impacts arising from the ‘use’ of organisms produced through biotechnology - not simply the release of those organisms and not only where the organisms are reproducing.
posted on 2015-05-05 15:47 UTC by Ms. Rachel Smolker, Biofuelwatch
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7043]
From Fred Bass, a physician/epidemiologist working with the Canadian Friends Service Committee on synthetic biology.  Here is my response to Mr. Ryo Kohsaka’s request for a briefer statement regarding how we address the relationship between synthetic biology and biological diversity.

A key issue for the Convention on Biological Diversity should synthetic biology’s lack of scientific attention to ecological and social impacts.  The AHTEG should supplement the closed-system perspectives offered by many practitioners of synthetic biology, with perspectives on how synthetic biology’s work might affect, directly and indirectly:
• biodiversity (particularly that of ecosystems) and
• human communities.

Therefore, I strongly recommend that the AHTEG membership include:
• two or more evolutionary biologists who are well versed in genetics and ecology and
• two or more social scientists whose work concerns the impacts of technology on human populations.

While for many, this approach may seem too broad, the massive loss of biodiversity and the social dislocation that is now occuring demands broad thinking and focused action.
posted on 2015-05-06 05:54 UTC by Dr Frederic Bass, self-employed
This is a reply to 6989 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7047]
Dear colleagues,

first of all I would like to thank Mr Kohsaka for chairing this discussion. I’m Valentina Rastelli, and I work for the Institute for Environmental Protection and Research in Italy.
Having to make a brief intervention, I want to say that I agree with those who argue that the relationship between synthetic biology and biodiversity should be analyzed at all levels, analyzing both benefits and risks. Regarding the risks, since organisms produced by synthetic biology techniques can fall within the definition of LMO, the provisions of the Cartagena Protocol and the relative risk assessment framework should be applied to them, in case of a release into the environment.

Best regards
posted on 2015-05-06 08:14 UTC by Ms. Valentina Rastelli, Italy
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7054]
Dear participants,
My name is Ilaria Ciabatti and I work at the European Commission as Policy officer on Biotechnology.
Welcoming the invitation to post short and concise messages, I would like to stick to the topic, which is how to address the relationship between synthetic biology and biological diversity. I would consider it a two-way relationship: biodiversity as a source of information, genetic material and systems used in SynBio applications and biodiversity as the target of potential effects of SynBio technologies and products. These effects may be positive or negative, may be intended (e.g. preservation of extinction endangered species or gene drives, see Esvelt et al. eLife 2014;3:e03401) or unintended and, as already repeatedly mentioned in previous posts, should be assessed against the three main objectives of the Convention.
I mentioned above both technologies and products, because it is certainly true that the characteristics of the organisms, components and products obtained through synthetic biology techniques are a determining factor on the potential impacts on biodiversity, but we should also consider that SynBio technologies are offering in a number of cases extreme rapidity and efficiency, with an extent of modification or novelty which makes the comparison with conventional counterparts challenging if not impossible.
Best regards
Ilaria
posted on 2015-05-06 11:08 UTC by Ms. Ilaria Ciabatti, European Commission
This is a reply to 7043 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7056]
Dear Moderator and forum participants,

I would request that statements such as those made by Mr Bass (#7043) are not allowed to go unquestioned.
“A key issue for the Convention on Biological Diversity should synthetic biology’s lack of scientific attention to ecological and social impact” is unsubstantiated and untrue.
Synthetic biology is characterized by its multi- and inter-disciplinary approach that goes beyond the lab in order to address issues such as the ecological and social impacts of the scientific advance. Not only have researchers chosen to adopt this approach, we are teaching our students to adopt these practices (http://igem.org/Human_Practices) at the same time as we are teaching them the scientific principles.
However, despite strongly disagreeing with the aforementioned statement, I do agree that the AHTEG should include appropriate representation from the fields of evolutionary biology and social science.

Thank you for your patience and hopefully we can continue with the discussion specifically focussing on "how to address the relationship between synthetic biology and biological diversity".
posted on 2015-05-06 12:10 UTC by Dr Louise Horsfall, University of Edinburgh
This is a reply to 7056 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7059]
Dear participants, thank you for keeping your interventions in a concise manner. 

At this initial stage,  I do not intend to express which posting was appropriate or acceptable but will appreciate it if you would express either your support/agreements or (strong) disagreements with postings or any existing literature. 

I appreciete proposals for organizaitons but I would rather not discuss the composition or nature of AHTEG here but rather focus on  " how to address relationship of the synthetic biology and biodiversity".
posted on 2015-05-06 13:37 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 7059 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7066]
Dear participants,

The Synthetic Biology has the possibility to present many applications including benefits to the conservation of biological diversity and may also poses risks in the way any impact of the technology should be assessed for both – positive and negatives impacts.

For risk assessment the principles for synthetic biology will be the same as those used for LMOs aiming to identify potential pathways to adverse efects. It´s also important to consider that most of the organisms obtained through synthetic biology are under containment and the exposure route in the context of RA is restricted as the environment exposure can be prevented in this case.

In other cases, where the synthetic biology  organisms will be released in the environment, the current framework for LMOs risk assessment can be adopted considering the organism, the genetic modification, the receiving environment and  the specific risk hypothesis being tested.

So the relationship between synthetic biology and biologial diversity should be addressed on a Science-based risk assessment and case-by-case basis.

Best regards,
Luciana / Ministry of Agriculture - Brazil
posted on 2015-05-06 18:31 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7070]
POSTED ON BEHALF OF DANA PERLS

----

Dear colleagues,

My name is Dana Perls, with Friends of the Earth, U.S. I appreciate the scope of the comments so far, and want to suggest some points of focus that need attention.
As several people have mentioned, CBD article 8g asks that parties regulate, manage, or control impacts arising from the “use” of biotechnology. These impacts are not just from the release of the synthetic biology organisms or the final synthetic biology derived products, but include the direct and indirect impacts from the greater process of synthetic biology techniques and production of synthetic biology organisms.

If we are truly discussing biodiversity, then we must look at the wider parameters and intersections and not narrow ourselves to a limited scope which may leave out some significant impacts. We must look at the social, economic, cultural, and agricultural impacts; these include land use changes, changes in agricultural production of feedstock, diminishing of botanical sourcing and natural product cultivation, loss of small farming livelihoods, and impact on equity of natural resource distribution. 

One of the significant impacts on biodiversity could come from the demand for feedstock. The increased demand for feedstocks to feed synthetic biology organisms, such as the yeast which produce high value flavors and fragrances such as vanillin, or such algae used to produce biofuels, could impact critical ecosystems and biodiversity, as well as the livelihoods and food security of smallholder farmers, forest-dwellers, livestock-keepers and fishing communities who depend on biodiversity, especially in the developing world.

The socio-economic impacts from synthetic biology are intrinsically linked to questions about biological diversity. Commodities currently produced by small farmers may be displaced in favor of synthetic biology products, many of which, such as synthetic biology derived vanillin for example, are being misleadingly marketed as “natural,” and the land they preserve may in turn be converted into industrial-scale plantations for soy, beef or sugar. This could also result in accelerated destruction of intact and biodiverse ecosystems and tropical forests across the global south. These significant impacts may be seen in the short term and must be addressed in both international and national regulations and assessments concerning synthetic biology.
posted on 2015-05-06 20:01 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 6862 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7081]
Dear colleagues,

I had a strong sense of “déjà vu” reading the statement from our esteemed colleague Ms. Li Ching Lim, Third World Network and  other colleagues  representing civil society  . Their concerns are legitimate – and identical -  to those expressed in the past against LMOs released to the environment ie. GM crops mainly produced by multinational companies and cultivated in developing countries,  where indigenous and other local  communities live,  and where the region of intentional  release of the LMO  may be a center of origin.

When discussing the relationship between synthetic biology and biological diversity and the protection of the environment and human health, I am certain that most stakeholders in this forum have identical final objectives: to have a way to  protect what is good, remediate what is contaminated and enhance what is “weak”   -- eg.  vaccines for say HIV, malaria or dengue  that don´t exist yet because of technical limitations,  that could maybe be overcome with novel  synthetic biology approaches.

We, the different stakeholders in this group, coming from different backgrounds, just differ in the “approach” on how to get there and how to safeguard the biodiversity of our planet – our only home.  If we cannot agree on an operational definition yet, let´s at least agree that we pursue a common goal.

As all stakeholder´s opinions must be considered, one important group of civil society that has been largely neglected in these discussion and that should be included,   is the voice and interests of “youth” – the new generation who are inheriting an already troubled planet.

Those of us who have the privilege and joy to work at universities with young people – especially those coaching iGEM teams or teaching synthetic biology classes - know that the “future generation” of professionals in biotechnology and synthetic biology are eager to contribute with solutions to the serious challenges we are facing.

This generation, more than any other previously, truly understands that our own survival depends on their generation´s ability to   do things differently and with integrity, to “think out of the box” and to bring novel solutions to seemingly intractable problems.  I think I am not mistaken, when I say that most of us, teach our classes with a strong component of bioethics and a strong commitment to biosafety.  Thus, I support the statement made by Dr. Louise Horsefall from Edinburgh University (# 7056).

The tools of synthetic biology, nanotechnology, artificial intelligence and other fields offer this possibility to the new generation. We (our generation) must help the youth of today – the future generations -  by not overwhelming  them with excessive regulation, like my generation  of public researchers suffered. This (perversely) paved the way for big industry to dominate the arena of ag biotech and left public institutions and small companies out of the race. We must not repeat the same mistakes again.
     
To ally some of the legitimate concerns regarding benefit sharing of Synbio and the impact on “local communities”, I was at an IGEM meeting in Monterrey, Mexico last weekend, organized entirely by students from one Mexican university to help other regional teams with their experience.

The participants included 10 young Honduran, Panamanian and Ecuadorian students from local universities, eager to learn the rudiments of genetic engineering and  how to make genetic constructs, so that they can compete in iGEM.  In the future, they may bring tangible solutions to intractable problems facing biodiversity, human health,  energy, agriculture and a greener industry.

Let me add that some students come from indigenous communities in Mexico, Central and South America and are studying with scholarships.  They chose to study biotechnology.
I feel it is our collective duty to help, and  not to hinder,  the efforts of this important group of stakeholders - the next generation of professionals.

Best regards from Mexico.
posted on 2015-05-07 05:18 UTC by Ms. Maria Mercedes Roca
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7087]
Dear Forum Participants,

My name is Kazuyuki SUWABE, and I’m in charge of environmental risk management of LMOs in the Japan Ministry of Agriculture, Forestry and Fisheries.

First of all, please let me thank the moderator Dr. Ryo Kohsaka for leading the lively discussion. I also thank all contributions from the forum participants so far, every input is very interesting and thought-provoking to me.

Given the question “How to address the relationship between synthetic biology and biological diversity”, I have been questioning myself if it is possible to interpret this as “Is there any different risk from LMOs, components or products of LMOs?”

There may be different severity but nature/characteristic of risk arising from organisms, components or products by synthetic biology seems same as the one from LMOs, components or products of LMOs in reading comments at this forum or reminding opinions at COP12 last year.

In summary, I would like to support that the current risk assessment methodology for LMOs, components or products of LMOs can also apply to those from synthetic biology, and that the risk should be assessed in a scientific manner and on a case-by-case basis, as mentioned by Dr. Louise Horsfall [#6998] and Dr. Luciana Ambrozevicius [#7066], recognising the potential to update the methodology as technology rapidly evolves and the need of fine tune such as finding an appropriate comparator in assessing risk of totally synthesised organisms in future.

With Kind Regards,

Kazuyuki SUWABE
Ministry of Agriculuture, Forestry and Fisheries, Japan
posted on 2015-05-07 11:48 UTC by Mr. Kazuyuki SUWABE, Japan
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7093]
POSTED ON BEHALF OF HIROSHI YOSHIKURA

----

Dear all,

This is a brief response of mine to Mr. Ryo Kosha’s request.

While biodiversity is determined by the evolvability of an organism on one hand, it is determined by interaction of various physical, biological and social factors, e.g., climate, soil qualities, resident organisms, land use, urbanization, etc., on the other. These interacting factors cannot be all identified as I already mentioned in the previous posting. The recently reported Gantz and Bier’s CRISPER system may be an example of SynBio products conferring evolvability (see Science 20 March 2015 vol.347 1300); the introduced mutation, disabling normal copies of pigmentation genes, transmitted itself to the next generation with 97% efficiency – a “near complete invasion of the genome”. But, depending upon the receiving environment, the SynBio organism may not expand. When all the influencing factors cannot be identified and assessed, the risk assessment needs the past experience with the related organisms in the similar environment; the comparative safety assessment is the basis of risk assessment in CBD. In this sense, introduction of a new SynBio product and that of a conventional living organisms or LMOs are similar. Consequently relation between biodiversity and SynBio is no different from relation between biodiversity and conventional organisms. Difference could be whether we have an experience to conduct the comparative safety assessment or not regardless of whether it is conventional, LMO or Synbio.
posted on 2015-05-07 15:32 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7043 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7098]
Dear colleagues,

My name is Dana Perls, with Friends of the Earth, U.S. I appreciate the scope of the comments so far, and want to suggest some points of focus that need attention.
As several people have mentioned, CBD article 8g asks that parties regulate, manage, or control impacts arising from the “use” of biotechnology. These impacts are not just from the release of the synthetic biology organisms or the final synthetic biology derived products, but include the direct and indirect impacts from the greater process of synthetic biology techniques and production of synthetic biology organisms.

If we are truly discussing biodiversity, then we must look at the wider parameters and intersections and not narrow ourselves to a limited scope which may leave out some significant impacts. We must look at the social, economic, cultural, and agricultural impacts; these include land use changes, changes in agricultural production of feedstock, diminishing of botanical sourcing and natural product cultivation, loss of small farming livelihoods, and impact on equity of natural resource distribution. 

One of the significant impacts on biodiversity could come from the demand for feedstock. The increased demand for feedstocks to feed synthetic biology organisms, such as the yeast which produce high value flavors and fragrances such as vanillin, or such algae used to produce biofuels, could impact critical ecosystems and biodiversity, as well as the livelihoods and food security of smallholder farmers, forest-dwellers, livestock-keepers and fishing communities who depend on biodiversity, especially in the developing world.

The socio-economic impacts from synthetic biology are intrinsically linked to questions about biological diversity. Commodities currently produced by small farmers may be displaced in favor of synthetic biology products, many of which, such as synthetic biology derived vanillin for example, are being misleadingly marketed as “natural,” and the land they preserve may in turn be converted into industrial-scale plantations for soy, beef or sugar. This could also result in accelerated destruction of intact and biodiverse ecosystems and tropical forests across the global south. These significant impacts may be seen in the short term and must be addressed in both international and national regulations and assessments concerning synthetic biology.
posted on 2015-05-08 00:09 UTC by Ms. Dana Perls, Friends of the Earth, U.S.
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7099]
Dear all,

My name is Jaco Westra from the Dutch Governmental Institute of Public Health and the Environment (RIVM), Centre for the Safety of Products and Substances. I am working as a policy advisor to the Ministry and coordinate the RIVM activities in the field of Synthetic Biology. I have a background of 20 years in risk assessment and policy analysis and policy development.

I am very pleased to be given the opportunity to join the discussion and I can hopefully add a useful viewpoint to the wealth of arguments being put forward in the forum already.

From my more policy oriented perceptive a line of arguments could be:
• 'Synthetic Biology' is a concept that is much too broad to discuss in terms of impact on or relation with biological diversity. It is a broad technological development with potential benefits and challenges throughout a wide range of applications. As has been put forward by a number of contributors already, an application or product-based approach in discussing the relation with biodiversity may be prove to be more productive and insightful. In general, the impact can be either negative or positive, and needs to be assessed on a case-by-case (or situation-by-situation) basis.
• An important underlying question for me is whether the development and application of the overall technology leads to an essentially new type of relation with/impact on biodiversity:
On the one hand we see:
o As recently has been restated by the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) - all current developments essentially fall within the scope of modern biotechnology and LMO's as defined in the Cartagena protocol.
o A number of synbio-related developments like the development of proto-cells, or the design and functional (non-coding) use of biomolecules in a development like DNA-origami are still only scientific.
o The current frameworks and machinery to identify and assess environmental and human health risks are, for this moment in time, applicable and adequate for both entities of biological or of chemical nature.
On the other hand we see:
o The developments in the field of synthetic biology - scientific, technological and business-related - are going quickly. The field is currently dynamic and productive.
o Many of the developments with a present or near-future market potential are related to the production of chemicals, and are within the realm of modern industrial biotechnology - that is closed system production (contained use).
o Other important developments can be seen in e.g. the ideas that are put forward in the iGEM competition. Here many of the ideas focus on e.g. biosensors and the non-contained use of specifically adapted micro-organisms (e.g. cleverly designed micro-organisms that act as crop protection agent). That is semi-contained en non-contained use applications are explored.

• My current take the situation is therefore:
o Presently, the developments in the synbio field are covered by our current thinking, which is condensed is the frameworks and definitions of (amongst others) the Cartagena protocol.
o Most of the synbio developments with a high or near market potential - are related to closed-system production (contained use). The question arises here whether the (potential) proliferation of these production methods (higher incidence of accidents and spills), and the present containment measures are sufficiently balanced.
o The field and the technological possibilities are developing rapidly. We need to monitor the developments closely. Additionally we need to assess where the boundaries of our current framework, definitions and assessment methodologies lie to anticipate future challenges. 
o Specific areas and developments of potential concern need to be identified for additional monitoring and assessment e.g. related to (semi) open use of LMO's e.g. biosensors, or micro-algae, including the possibilities of biocontainment.


I am looking forward to further engaged and fruitful discussions. Finally I want to thank the secretariat for providing the excellent overview document on the relation between synthetic biology and biodiversity.

Respectfully,

Jaco Westra
posted on 2015-05-08 09:01 UTC by Mr. Jaco Westra, Netherlands
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7111]
Dear participants,
My name is Ana Atanassova and my background is in molecular biology and GMO regulatory policy and risk assessment. I am grateful for the opportunity to contribute to the discussions of the forum.
In my answer  I address the objectives of the Convention from a scientific perspective, which considers the tools of ‘synthetic biology’ to be within the definition of ‘modern biotechnology’, and products of ‘synthetic biology’ to be within the definition of LMO of the Cartagena Protocol.
Considering the consensus on the forum that “synthetic biology” is  a broad technological platform to develop diverse products, it is relevant to state that biological diversity can be impacted when there is a release into the environment of organisms developed with “synthetic biology” approaches, similar to the impact from the introduction of any other foreign  organism, including LMOs,  in a receiving environment.  Both, risks and benefits of the environmental release of the organism should be considered in relation to biological diversity.
The existing provisions of the Convention on Biological Diversity  and Cartagena Protocol provide an adequate framework for addressing the risks of organisms developed with the use of “synthetic biology” approaches. It is important to underline that assessment of organisms developed using “synthetic biology’’ approaches should depend on the nature and characteristics of  organism as opposed to  the process and/or components  used to develop it.
• conservation of biological diversity
The potential benefits of  “synthetic biology”  applications, in a broad sense, include enabling more environmentally friendly solutions to current production methods or solutions for challenges that could not be tackled previously. The potential risks associated with the conservation of biological diversity where “synthetic biology”  organisms are released into the environment would be adequately addressed by the existing risk assessment provisions of the Cartagena Protocol.  As other participants have stated, applications of “synthetic biology” concern processes conducted in controlled environments, such as fermenters. In this case, the long-established principles and procedures of biological containment apply, and the potential impact on biological diversity will be negligible.
• sustainable use of the components of biological diversity
Potential (indirect) benefits from the development of “synthetic biology”  might be the reduction of environmental pressure caused by current production methods, e.g. sourcing compounds from wild species of plants, and the ability to transfer the process to production environments away from centers of biological diversity.
It  should be noted that, in relation to the above two Convention objectives, the language of the Convention and the Cartagena Protocol recognize that not all LMOs will have an adverse effect on the conservation and sustainable use of biological diversity, as they only concern those LMOs that ‘may have adverse effects’. This supports case-by-case assessment as appropriate to address potential risks.
Kind regards,
Ana Atanassova, Bayer CropScience, representing Crop Life International
posted on 2015-05-08 16:23 UTC by Ms. Ana Atanassova, Bayer CropScience
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7115]
In response to the request from Dr. Ryo Kohsaka, to provide some brief additional comments,  I agree with the views expressed by many other contributors that, although synthetic biology is not specifically mentioned, the existing provisions of CBD & associated protocols provide an adequate framework to manage the risks to biodiversity arising from relevant and current applications of synthetic biology. Going forward, as the discipline matures specific examples of complex and novel organisms may emerge. Risk assessment methodologies may need to adapt but would still be consistent with existing approaches where periods of contained use and well-monitored environmental releases can be used to reduce uncertainty to acceptable levels before subsequent authorisation for environmental release. Discussions are already underway in the Risk Assessment and Risk Management AHTEG under the Cartagena Protocol, which should helpfully inform this discussion.

Given this, it is important that Parties who have decades worth of experience in the safe regulation of GMOs and LMOs are able to share their knowledge with other Parties, especially those who wish to make use of such technologies. This could help those Parties in developing their own national regulatory frameworks in a way that is both proportionate and pragmatic. Capacity building projects under the Cartagena Protocol are supporting Parties in developing these frameworks.
posted on 2015-05-08 17:24 UTC by Mr. Michael Paton, United Kingdom of Great Britain and Northern Ireland
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7118]
Dear Participants,

My name is Dr.Todd Kuiken. I am an environmental scientist and the principal investigator of the Woodrow Wilson Center's Synthetic Biology Project. (http://www.synbioproject.org).  I am also a founding member of iGEM's biosafety/security committee. I would like to thank the moderator and the other participants for such a robust and exciting discussion so far.

I would like to support the comments provided by Kent Redfod (#6875) and suggest that the relationship between synthetic biology and biological diversity in relation to the first two objectives of the convention do not need their own unique rules. While there have been issues identified that suggest synthetic biology may have some unique traits that require new evaluations in terms of ecological impacts (see attached Wilson Center report on eco effects), these are captured by the current mechanisms within the protocol in regards to risk assessments.

In regards to the “The fair and equitable sharing of the benefits arising out of the utilization of genetic resources”, I would like to support, in part, the comments provided by Jim Thomas (#6857). While the digitization of genetic code is not unique to synthetic biology, the wide distribution/sharing of genetic “parts” and the increasing amount of actors though out the world, as evidence by the Woodrow Wilson Center map (http://www.synbioproject.org/inventories/maps-inventory/) and the expansion of iGEM (http://synbioconsulting.com/igem-synthetic-biology-map/) suggests that it will be difficult to keep genetic resources “in country” or prevent their use, whether there is IP associated with it or not. While iGEM (http://igem.org/Main_Page) ships physical “parts” the kits contain genetic elements from multiple sources and the Registry of Standardized Parts (http://parts.igem.org/Main_Page) now contains over 10,000 individual genetic elements.

As a founding member of iGEMs biosafety/security committee the shipping, sharing and utilization of such a vast array of parts, as well as the creation of new parts, presents a challenge in relation to “The fair and equitable sharing of the benefits arising out of the utilization of genetic resources”. Because we are dealing with “parts” and not the full sequence, how the Protocol deals with “derivatives” will ultimately decide how/whether the Nagoya protocol will be effective and/or enforceable.  The Woodrow Wilson Center has begun to explore some of these issues in the attached report (see attached Wilson Center report on Nagoya Protocol), and we will be issuing a more in depth analysis on how synthetic biology and the Nagoya Protocol interact later this summer/fall.


Kindest regards,

Todd Kuiken
posted on 2015-05-08 19:38 UTC by Mr. Todd Kuiken, North Carolina State University
This is a reply to 7118 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7122]
Dear participants,

We will soon wrap up so please give a brief comments (2-5 lines) if you would still have any comments or responses.

I see number of participants have discuss with reference to Cartagena Protocol and texts of the Convention (some within the existing scope and others beyond) to address the relationship.
(edited on 2015-05-09 07:26 UTC by Mr. Ryo Kohsaka)
posted on 2015-05-09 07:25 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 7122 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7123]
Dear all,
I would like to make use of this opportunity to give a final short reaction and support Michael Patton [#7115] and others in that we have an adequate  risk assessment framework in place for LMOs to assess and manage potential risks to biodiversity, which is equally applicable to organisms developed by synthetic  biology. This framework will also be applicable to future, de novo developed, synthetic organisms that will be released into the environment. Much experience has been gained already with LMOs, and new experience is gained at this moment with new generations of LMOs that exhibit new or more complex traits. By using the same framework, we notice that methodologies and/or the nature of data needed to assess these new LMOs can be different, but the framework is still applicable. This same methodological flexibility can be applied in the assessment of future synthetic organisms with new and complex traits.  In my opinion, we have the tools (framework), but we may have to apply them in a different way in order to adequately protect biodiversity  from synthetic organisms.
Kind regards, Boet
posted on 2015-05-09 15:54 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7129]
Dear all participants,

According to the recetly published paper which was reproted by Dr. Kina Tyndt et al.,, Ghent University, they identified two bacteria derived genes in edible sweet potate which we eat now.   The two genes are not detected in wild type sweet potate.  The gene modified species(GMO) was established at least 10 thousand ago.
(http://www.pnas.org/cgi/doi/10.1073/pnas.1419685112)

I believe that there are such many examples in plant and animal.  And i assume that the way of spontaneous gene modification (Horizontal gene transfer:inserting external materials) is the same way as the current modernbiotechnology and synthetic biology(including genome editing) do.  Then we eating the GMO(modified sweet potate) now.  But there are no health harmful effect on human and on CBD. 

Certainly there are many toxic materials, such  as tocic mashroom and others.  But we can evaluate the risk on product basis and case by case under the existing regulation system.

In the begining of this discussion, I stated that we have already made experiences of modern biotechnology more than 40 years. And if the technics of synthetic bology is the almost same as that of modern biotechnology, it is the same thing.  I must make a correction of the satetement as follows; "we have already made experiences of genetically modified technologies(including synthetic biology) more than at least 10 thousand years.However, it is difficult to find some harmful effects of the technologies on  biological diversity”.

Thank you for all.                                Hideyuki
posted on 2015-05-10 05:58 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7134]
Dear fellow participants,

My name is Margret Engelhard, I am working at The German Federal Agency for Nature Conservation in the area of GMO Regulation and Biosafety.

One of the key paradigms of synthetic biology is to optimize methods and tools for the development of synthetic organisms for a desired aim. This brings along an increase of speed in the development of new organisms and an expansion of the scope of design. With tools like CRISPR/cas this development will gain momentum. For the conservation of biological diversity and the sustainable use of the components of biological diversity this will bring along a number of practical problems:

1. The current risk assessment framework for LMOs will be challenged on two levels:

> The quantity of new applications that have to be evaluated with respect to their impact on biological diversity will bring evaluating bodies to huge capacity problems. In solving this problem it is important to stick to a strict case-to-case assessment and not generalizes on any platform organism or pathway.

> As engineered organisms become increasingly complex, risk assessments will pose a greater challenge: More complex engineered organisms lack the familiarity to organisms that we have long lasting experience with. Thus the level of uncertainty in the evaluation of the impact of these organisms on biodiversity is rising. This is the reason, why a precaution principle is applicable on the release.

2. On the level of fermenter driven production, large scale industrial applications are envisioned. Here again the difference to current applications is a difference in scale.

> This change of volume will challenge the sustainable use of the components of biological diversity, since it will add up to the already existing pressure on biomass.

> The rising quantities of fermenter biology will higher the risks of unintentional release that might cause negative effects on biological diversity.

Best regards,
Margret Engelhard
posted on 2015-05-10 12:10 UTC by Ms. Margret Engelhard, Germany
This is a reply to 7134 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7137]
Dear Secretariat, moderator and colleagues,

Let me first introduce myself. I am Katileena Lohtander-Buckbee and I work at the Finnish Environment Institute in Helsinki, Finland. My background is in systematic botany and ecology and I deal with issues related to risk assessment of LMOs and access and benefit sharing of genetic resources (Nagoya Protocol). I have prepared this short intervention together with my colleague Marja Ruohonen-Lehto who has a background is in genetics, microbiology and virology. Her duties include risk assessment of LMOs, national and international obligations on species protection and genetic resources. Marja Ruohonen-Lehto also represents WEOG in the AHTEG on Risk Assessment and Risk Management under the Cartagena Protocol on Biosafety.

We have followed the discussions with keen interest and think that all the comments provided will be useful for our future work. While many constructive comments have already been posted we can be quite short on our intervention. Most applications of SynBio so far have resulted in living modified organisms (LMOs). These organisms should be assessed according to provisions set out by the Cartagena protocol. This assessment should cover all levels of biodiversity: genetic, species and ecosystems. The basic steps of risk assessment will be the same (as in any risk assessment) but in case of SynBio produced organisms we may need to adjust the assessment, for instance, on data requirements and comparative approach while comparators may not be easily available. For also non-living entities (components and products may not be living) assessment framework(s) do already exist(s) and will be helpful in developments under the CBD discussions.
posted on 2015-05-10 15:29 UTC by Dr. Katileena Lohtander-Buckbee, Finland
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7145]
Good afternoon to all!
I am Francisca Acevedo, and work in Mexico at CONABIO, an institution dedicated to gather knowledge on biodiversity and its use. CONABIO has been involved in biosafety for a long while now, and I have been leading a group dedicated to risk assessment on the release of LMO into the environment for twelve years.

I have seen some some participants suggesting of taking out of the AHTEG on risk assessment of the Cartagena Protocol the topic on Synthetic Biology. I really recommend this is not done. We have seen that CBD and the Cartagena Protocol have not interacted as much as some of us wished, and it is time they really do. Leaving the subject in the two bodies (two AHTEG and online forums) will hopefully potentiate much more interactions and more common views on ways forward on these very challenging issues. I do not think this will create duplications but will foster transversal work among the different bodies.

Kind regards,
Francisca
posted on 2015-05-10 18:05 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7148]
Hello

My name is Paul Freemont and I am co-founder and co-director of the Centre for Synthetic Biology and Innovation at Imperial College (http://www.imperial.ac.uk/syntheticbiology). I have enjoyed reading the many postings and  different viewpoints and will keep my comments very brief. I wanted to address the three contexts that out excellent moderator stated in the opening of this thread.

The conservation of biological diversity - This is a key topic for discussion and as many participants have argued that synbio is among many technologies (new and old) that can result in genetically altered organisms (LMO's)  and as such a simpler concept might be to consider such LMO's in light of their subsequent phenotypic traits and not the methodology that resulted in the LMO. Distinctions should also be made between deliberate and accidental release and I note arguments from conservationists pointing out the potential negative and positive impacts. The interface between LMOs that are released and their ability to alter natural biodiversity or interfere with ecological balances require much more research and safety considerations which in my opinion should be developed on a case by case basis (as suggested by other participants).

The sustainable use of the components of biological diversity - This is an open-ended question with no definitive answer in my opinion.  As defined in many posts synbio uses digital genetic information for the redesign of biological systems and cells for defined applications. Such digital information is fully sustainable as long as we have electricity, hard drives and the internet. In terms of synbio applications which perhaps is much more relevant to this statement is the future sustainable use of feedstocks for biomanufacturing processes involving contained synbio engineered organisms (already noted positively and negatively by other participants). An exciting development in the synbio field is the use of waste sources as a sustainable feedstocks (e.g. municipal and industrial waste streams) . If such feedstocks can be effectively utilised with appropriate engineered LMOs and their sustainability quantitatively modelled then such solutions could be considered highly beneficial – for example see the Imperial iGEM project “Plasticity”  (http://2013.igem.org/Team:Imperial_College) which also relates to the post about the future generation of researchers and their desires to tackle serious global problems responsibly using synbio approaches.

The fair and equitable sharing of the benefits arising out of the utilization of genetic resources - I view this as a political question and as a scientist I am not qualified to make any judgements or qualified statements – I have a personal view but so does every participant in the forum and I am not sure that my view will add anything of value to this political debate. I do however note that the synthetic biology field has open access at the parts level and software tools at its core. I am hopeful that with iGEM and the future generation of researchers that we are now training both in research and human practise, that this ethos will be maintained and expanded which ultimately may contribute positively to this political debate.

Finally as a keen as a keen gardener, I was researching into the history of  English gardens and their plants and came across this fascinating article (http://www.cabinetmagazine.org/issues/6/preston.php). The author describes the enormous tensions around the 19th century import of exotic pants into England versus the indigenous fauna. Despite these vigorous debates much of what we enjoy in classical English country gardens today has in fact evolved from these imports (driven by taste and the developing seed market) and many such plants are now fully integrated into our biodiversity. Some have been beneficial (sycamores) but some invasive and not beneficial (e.g. rhododendron, Japanese knotweed).  It is clear that synbio technology will enable the considerations of deliberate release of organisms into the environment and it is essential that a robust debate be conducted (like this forum) but perhaps we can look at historical parallel discussions and debates around related topics which may inform our thinking.
posted on 2015-05-10 18:41 UTC by Mr. Paul Freemont, Imperial College London
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7149]
Having read  many contributions to this questions I want to summarize some basics:

We have to be aware that the uncertainties of short-term and long-term risks are increasing in the context of Synthetic Biology. There are several reasons for this. For example, we know that the former (linear) paradigm based on DNA makes RNA makes protein is not sufficient to explain complexity in gene regulation, heredity and evolution. But many of the applications of Synthetic Biology such as genome editing are still based on this paradigm. To give an example, the risk assessment of new miRNA produced in transgenic plants (be it intentionally or unintentionally) is a major challenge and has been overlooked for many years. In context of Synthetic Biology, effects emerging from RNAi is becoming even more relevant.

We also have to be aware that in the age of the “Anthropocene”, biodiversity has already been severely impacted by human activities such as those in agriculture and land use. Synthetic Biology is likely to add a whole new extra level of risk to biodiversity.

Consequently, the answer to the question of how we should address the relationship between synthetic biology and biological diversity is undoubtedly to place more emphasis on the precautionary principle. This principle is the most relevant and most rational approach when dealing with the new technologies, uncertainties and risks emerging from Synthetic Biology.
posted on 2015-05-10 18:53 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 7149 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7154]
Dear All

I am Thomas Heams, assistant professor in functional animal genomics in AgroParisTech (the Paris Institute of Technology for Life, Food and Environmental Sciences) and INRA (the french National Institute for Agricultural Research), two public institutions for Education and Research. It's an honour and a pleasure for me to be part of this forum.

Thanks to all of you for all these rich and inspiring contributions, and thanks to the moderators for the good job done. And I do apologize for this late contribution.

Regarding this topic “How to address the relationship between synthetic biology and biological diversity”, lot of elements have been debated here.

I would add that on this topic, Synthetic Biology (SB) is a double edged issue. One may first think of Synthetic Biology as a potential threat for the current biodiversity, think for example of an SB bacteria that would have been engineered for its fitness, and would therefore out compete existing natural species. This must be cautiously taken in consideration, but one should not forget that some SB approaches explicitly address this issue, e.g. xenobiology (in making organisms so dependant on a “non natural” input that they would not be able to survive in the wild) Besides this, I guess the main threat that SB organism could have on biodiversity is not in their biological nature, but rather would come from their industrial and commercial origins. To this respect, this falls into the general debate about the social impacts of GMOs/LMOs.

But with other lenses, SB could also increase biodiversity. New species could be evolved, new genes could written, new combination of gene could be engineered, new biomolecules could be integrated in the living world. From a pure theoretical point of view, this has a significant scientific interest, and might unleashed our creativity, in medicine for example. As a scientist working in Agricultural sciences, I know for a fact that selection practices do not lead directly per se to a reduction of biodiversity (even if bad practices and economy-based pressures often lead to it). The living world is ruled by natural selection and it never ceases to generate diversity. Therefore any new sources of variation changes our way to understand this living world. SB may be one of them.

That said, I could not warn enough about the caution and wisdom that should lead such SB studies, with a constant dialogue between scientists and society. The current living world is full of surprises and resources that may, if better documented, challenge the need for industrial SB-based products. It is our duty to provide society good information about this needs  : is SB necessary for society as a whole, or only for the biotech private companies ?
posted on 2015-05-10 19:26 UTC by Mr. Thomas Heams, AgroParisTech
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7158]
Dear participants,

I am María Andrea Orjuela, currently I work in CONABIO (Mexico). I am involved especially in GMO risk assessment and biosafety issues.  It is an honour and a pleasure for me to be part of these fora.

Thanks to all of you for all these stimulating contributions and thanks to Ryo Kohsaka for your guide. I do apologize for this late contribution.

I agree with the Genya V. Dana, Jim Thomas and Ricarda Steinbrecter that, I think, illustrates very well the real point about possible effects or interactions of SynBio components and products and biodiversity. In the other side I believe that are very valuable the proposal of Ossama Abdelkawy and the points indicated by Lim Li Ching.

Since my point of view is important to have an integrated vision about biodiversity, this means thinking not only in structure levels (genes, species, ecosystems) but also taking into account the functionality of systems (ecosystems, agroecosystems, socioecosystems) and the possible way that those would be impacted.

Finally I want to point out that for me the most relevant process to evaluate are the product and its interaction with the environment more than the technique that was used for its design, and here is very relevant the real predictability that is possible to have for SynBio products outside the laboratory, I really think ii is very uncertain.

Kind regards,

M. Andrea
posted on 2015-05-10 21:20 UTC by Ms. María Andrea Orjuela Restrepo, Mexico
This is a reply to 6760 RE: Opening of the discussion: “How to address the relationship between synthetic biology and biological diversity” [#7174]
POSTED ON BEHALF OF YONGBO LIU
Note: this message arrived at the Secretariat before the closing of the discussion.

----

Dear Participants of the Online Forum on Synthetic Biology,

Greetings from China.

My name is Yongbo Liu, from Chinese Research Academy of Environmental Sciences, belonging to the Ministry of Environmental Protection of the People’s Republic of China. My research field is mainly on the biosafety assessment of GMOs, including the effects of GMOs on target and non-target organisms. I am also interested in the biosafety assessment of products from synthetic biology.

To address the relation between synthetic biology and biological diversity, there are lots of excellent debates. For example, I totally agree with Dr. Jim Louter [#6796] who pointed out that “the relationship between an organism (whether an LMO, a GMO, naturally occurring, or a product of SB) and  'biodiversity' is described by the results of a risk assessment. The risk assessment determines whether the organism (which in this case, is a product of synthetic biology) will (or will not) have an adverse effect on a component of the environment. If the product of synthetic biology is not 'alive', the risk assessment model would be different but the basic principles of risk assessment would still apply.”

Besides the direct risks of SynBio products (I also agree products, not process) to biodiversity, I think there are two aspects to consider: 1) the utilization of biological diversity for producing SynBio products should be paid more attention; 2) employing the SynBio to produce products that were from natural resources before. It should also be evaluated to make clear they will lead to what effects on biodiversity. For example, artemisinin is generally produced by the plant Artemisia annua, and it is now synthetized using synthetic biology to develop strains of Saccharomyces cerevisiae (baker’s yeast) (Nature, 496: 528–532, 2013).

In addition, GMOs have target organisms, for example Bt plants are developed to control the Lepidoptera family. Whether SynBio products also have target organisms or not will determine their biodiversity effects. This is also one of differences between SynBio and GMOs.

Looking forward to further discussions, and with greetings to all!

Cheers,
Yongbo Liu
posted on 2015-05-12 19:49 UTC by Ms. Manoela Miranda, UNEP/SCBD