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Opening of the discussion on topic 4 [#7198]
POSTED ON BEHALF OF CASPER LINNESTAD (MODERATOR)

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Dear participants of the Online Forum on Synthetic Biology,

My name is Casper Linnestad and I work in the Ministry of Climate and Environment in Norway. I am the national focal point for the Cartagena Protocol on Biosafety. My background is within genetics and gene technology and my Ph.D (in the previous millennium!) was on endosperm development of maize and barley. Over the last 15 years I have been involved in the regulation of LMOs. One central aspect has been how to operationalize our national gene technology act when it comes to the assessment criteria social utility, ethics and sustainable development.

I have been following the discussion under this forum with much interest and thank all who have contributed to a rich and lively debate so far.

It is a great honour for me to moderate the next topic in our agenda focusing on “Potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols”.

As most of you may be aware of, the Convention on Biological Diversity establishes three main goals: the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits from the use of genetic resources. In addition, the Convention has two Protocols: the “Cartagena Protocol on Biosafety”, which aims to ensure the safe handling, transport and use of living modified organisms resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health, and the “Nagoya Protocol on Access and Benefit-Sharing” which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way.

The present discussion and next steps in this process provide us with a unique opportunity to assist countries that are, or will soon be, establishing regulatory regimes that prepare the ground for achievements and new products within/from synthetic biology and, at the same time, ensure the conservation of biodiversity while taking into account the human health and socio-economic dimensions. 

Building on the views shared during the previous round of discussion, and in particular the interventions posted under topic 1 on the relationship between synthetic biology and the conservation of biodiversity (https://bch.cbd.int/synbio/open-ended/pastdiscussions.shtml#topic1), I would like to invite you to consider, within the mandate of the Convention and its Protocols:

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?
3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

To assist in the discussion, the Secretariat made available the relevant sections of the CBD Technical Series no. 82 on Synthetic Biology as background documents (pages 25-37 and pages 41-50; available at http://bch.cbd.int/synbio/open-ended/discussion.shtml#topic4). 

When sharing your views, I kindly ask you to be concise and focused on the task at hand. Whenever possible, please avoid lengthy introductions and unnecessary repeating of what has already been posted in previous rounds.

I am very aware of the fact that most of you are very committed also to other tasks. Nevertheless, I sincerely hope that you will be able to participate in this forum and trust that it will be informative, constructive and beneficial to all of us.

Best wishes and good luck!
Casper Linnestad
posted on 2015-05-25 01:19 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7199]
Dear all participants and Secretariat in this forum,,

My name is Hideyuki Shirae, PhD., working Japan Bioindustry Association, and I’m going to participate in this forum on behalf of the Japanese government. I studied microbiology and immunology in Kyoto University and then Stanford University as a postdoctoral student. Sincer 1998, I engaged in business development and licensing in pharmaceutical business. 

First of all I express my sincere thanks to the Secretariat and moderators for coordinating this online forum and it’s a great pleasure for me to share views and opinions about topic4 with many remarkable scientific experts in the world.  I really learnt a lot of things from their thoughts submitting in the discussions of each topic from 1 to 3 regarding the issue of synthetic biology.

During the discussion from topics 1 through 3, we can find some common concepts (mutual agreements.  The first common concept is the basal techniques of the synthetic biology are derived from traditional genetic engineering techniques or the genetic engineering techniques on the extension line.  The second common concept is “organism” of the synthetic biology should be “LMO” or be similar with “LMO” defined in the Cartagena Protocol.  However, there are some different opinions and thoughts about “components”, “products” and “(operational) definition of the synthetic biology. 

If the balsa techniques of the synthetic biology derived from the traditional genetic modified technology, as I explained in the topic 1[#6764], the technology has already been passing for more than 40 years since it was reported in 1973, but there are no any bad effects on the biodiversity in nature. In other words, the technology which currently argued in COP does not affect the biodiversity, including its conservation and sustainable use and related human health and socioeconomic impacts, and can be regulated by Cartagena Protocol.

I also believe the “products” of the synthetic biology must be some kinds of reproducing entities, like LMO, because only such reproducing entities can show something to the environmental influence for a long time.  The change of biodiversity might be needed by receiving the continuous stimulation. If “Products” should be a non-producing entities, such as small molecules, the effects on biodiversity could be much limited and for a short time.  It will shortly restored as the original state of biodiversity.  As such, we do not need any procedures of risk assessment of them.  Also “ Components” must be characterized the “Products” which consist of some sophisticated “organisms”.  Therefore, both “Products” and “Components” also do not give any effects on biodiversity.

Some arguments exists about the ”Products” which are small entities produced by “organisms”
[#6832, #6930, #7004, #7004, #7121, #7078, and #7098].  But all the claim are irrelevant in this online forum because such small entities exists for long time on the earth and it is proved that there are not effects on the conservation and sustainable use of biodiversity , and related human health and socioeconomic impacts.  Some gave us vanillin as the example of “Products”. (page 30-31 of the CBD Technical Series no. 82 on Synthetic Biology as background documents) However, it is safe and no problems for human health and use for food and a flavor in the world.  The Vanillin is mainly produced by organic synthesis from petrochemical materials.  In 2011, the total market of vanillin was 16,500 tonnes, 15,000 tonnes (91% of the global supply)from petrochemical-based sources and 1,500 tonnes are produced from lignin.  The average price is only US$12-25/kg. The amount of natural extract forms of Vanillin from vanilla beans was only 30 tonnes (total market share 0.2%) . The natural extract form of Vanillin is a mixture of several hundred different compounds, and it is used for only high graded cosmetics/liquids due to its higher price(US$1,200-4,000-).  (The source: MBA degree reports by Jason Timothy Wong in Simon Fraser University in 2012)
According to the EPOPA(Export Promotion of organic products from Africa)’s 2005 reports,
The global demand of vanillin in 2004 had shrunk by 45 percent compared to the average 1995–2000 level of 2,000 tons, to reach 1,100 tons (Zink & Triest reported).  Trade data from FAOSTAT suggests that global apparent consumption was roughly 1,500 tons in 2002, down from 2,500 tons in 1999. This puts the market at 9 percent below the level of 1993. In a period of 3 to 5 years, therefore, the market has lost by about 1,000 tons.
That means the trade amount of natural Vanillin reduced year by year since 1990’s, and its market position is taken by petrochemical-based products because of their low-prices, regardless of an appearance of the vanillin derived from synthetic biology.
The above fact indicates no any socioeconomic damages exist in vanillin case.

At last the vanillin produced by synthetic biology is a vanillin beta-glucoside, non-natural form, and is manufactured in completely contained facilities. Any products/organisms are not released in the environment. Therefore, they are not given any effects on maintenance and conservation of biodiversity, human health and ecosystem .

Best regards,

Hideyuki
posted on 2015-05-25 04:41 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7200]
Dear Participants,

Here is an real-world example from the company I founded in 2009, Phytonix Corporation, of the potential benefits and risks of organisms arising from synthetic biology techniques to the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols”:

Turning carbon dioxide into renewable chemicals and fuels:

Phytonix Corporation utilizes synthetic biology to enable the integration of 21st century scientific ingenuity with the ancient and elegant process of photosynthesis. Starting with the most energy and photosynthetically efficient natural microorganisms on Earth, cyanobacteria, synthetic biology allows us to substitute, in a bio-safe manner, a target chemical synthesis pathway for the natural food production pathway of the organism.

Phytonix is a leader in the area of biosafety guarded synthetic biology technology. Although our organisms are not inherently dangerous and are grown in enclosed systems, we believe that in order to maximize benefits and minimize risks of this emerging technology to global environmental health and biodiversity, it is both a priority and a moral obligation to utilize redundant biosafety guards, either natural, engineered, or both. Phytonix has developed a number of proprietary technologies as well as naturally-based biosafety strategies, to ensure the biosafety guarded use of its engineered microbes. This biosafety guarded technology can also be applied to other types of microbes produced via synthetic biology across the biotechnology industry and in academic research laboratories.

With this approach, we are able to create biosafe microbial chemical production platforms that can directly convert carbon dioxide via photobiology as the sole, direct feedstock into valuable renewable chemicals and biofuels. CO2 needs no longer to be seen as a waste product with dangerous environmental effects, but increasingly as a valuable feedstock for chemicals, fuels or polymers.

This positive vision has been gaining momentum and is now emerging from research laboratories and new commercial ventures as a realistic alternative path to securing the constant supply of carbon atoms the industrial chemistry sector will continue to need for their production cycles, even in a future world where fossil resources may be completely depleted, all enabled by the evolving field of synthetic biology.

Combining nature and science in this manner holds great potential to provide for civilizations’ future chemical and transportation fuel needs while alleviating the stress on Earth’s environment, such as anthropogenic climate change, in order to maintain, maximize and ensure global biodiversity.

Thank you and best regards,

Bruce
posted on 2015-05-25 11:24 UTC by Mr. Bruce Dannenberg, Phytonix Corporation
This is a reply to 7199 RE: Opening of the discussion on topic 4 [#7201]
Dear colleagues,
My name is Nikolay Tzvetkov and I work at the Biodiversity Unit of Bulgarian Ministry of Environment and Water.
When discussing the potential risks and benefits from synthetic biology products, components and organisms on the environment, incl. the conservation and sustainable use of biodiversity and on human health, we should keep in mind that case-by-case approach should be followed and generalizations necessarily will be too coarse.
One major difficulty that will make potential risks harder to estimate is the lack of suitable comparators, as synthetic biology organisms by default contain new features significantly different those of other living organism. These potential risks can include increase invasive potential in certain environments, unexpected effects on health, etc. or more indirect ones, like change of agricultural practices that harm the biodiversity, changes in the nutritional status of people and related health issues.
Potential benefits can also be substantial, for example, some synthetic biology organisms have features that make their persistence in the environment very unlikely, others can be used to utilise certain carbon sources, harmful for the health and with long half-lives, production of substances that are presently produced from scarce natural sources, more efficient therapies with less side effects, etc.
Finally, once again I want to highlight that determining the risks and benefits from a synthetic organism case-by-case approach should be followed. Once more experience is accumulated certain features of synthetic biology organisms may emerge that may make them more risky or beneficial for health and environment. On the other hand some of the lessons learnt from more than 40 years of use of LMO might be relevant as well.
Best Regards,
Nikolay
posted on 2015-05-27 10:06 UTC by Mr. Nikolay Tzvetkov, Bulgaria
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7202]
Thank you Casper for your introduction and for accepting to be the moderator of this forum.  By way of introduction to you, I have been actively involved in the regulation of products of biotechnology in Canada since 1994 including many environmental introductions and a few landmark decisions. The following are my opinions and not those of my employer; I think it best that we focus on the 3 questions you have posed, namely:
1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?
3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

1) The answer to this question is the purpose of a risk assessment; there are simply too many variables to generalize a response, i.e. this will be determined on a case-by-case basis. The 'potentials', either way, are enormous and this is true for organisms, components and products.
2) Whether biological diversity is the endpoint or human health, the answer is the same as above.
3) In our Government, assessment of socioeconomic impacts only happens under specific circumstances (for example, once having determined there is a risk, and risk management options must be considered, socioeconomic factors are considered when looking at which risk management option to implement; another example could be assisted human reproduction or other applications that are applied directly to humans).  In Canada, socioeconomic factors are normally not part of the risk assessment.  In order to prioritize our resources, we have tended to ensure there is, at a minimum, a base-line assessment of possible risks to the environment (effectively what we are talking about with respect to biological diversity) and human health.  In several product areas there is also an assessment of benefits/performance/efficacy (eg. drugs, pesticides, new crop plant varieties, fertilizers) that is added on to the assessment of risks to the environment or human health. 

One last comment: in Canada, as a policy, we separate science-based risk assessment from other types of ‘technology assessments’; the latter is best promoted by the parts of the government for whom the mandate is economic development and not by the regulators.

Thanks

Jim Louter
Biotechnology Section
Environment Canada
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=E621534F-1
posted on 2015-05-27 14:15 UTC by Mr. Jim Louter, Canada
This is a reply to 7202 RE: Opening of the discussion on topic 4 [#7203]
Dear all,

I would like to thank the moderator and the participants for this interesting discussion.

In my opinion some importante points from the previous messages are:

- the necessity to differentiate among organisms, components and products as already discussed by Dr. Shirae (#7199) in a risk assessment context

- the obligatory nature of a case-by-case assessment (#7201 and #7202)

Having these points on mind is really difficulty to answer such broad questions  and make the answer usefull in the context of this on line forum. Anyhow trying to focus on the task and using the experience with GMO risk assessment:

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?     
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?

The questions 1 and 2 can be answered together in general terms:

The potential benefits are related with synthetic biology applications: to design and build engineered biological systems that processes information, manipulate chemicals, fabricate materials and structures (chemicals, proteins, enzymes, and fibers), produce energy (new fuels,  biofuels, low-carbon fuels, energy security), provide food (plants and animals resistant to diseases and pests and/or adapted to different regions with high productivity), and maintain or enhance human health (pharmaceuticals, vaccines, hormones, diagnostic agents) and the environment (detection, treatment and pollutant degradation, bioremediation, biomining, reduction of greenhouse gas emissions, development of environmentally-friendly plastic, etc). It is important to mention that Synthetic Biology also can be used to address some of grand challenges facing society: climate change mitigation, energy security, applications on agriculture to address water, soil and food security, improving the health of the world´s poor and of ageing populations, and environmental protection (James C. Philp. Emerging Policy Issues in Synthetic Biology, 2014. OECD).

The potential risks are the same as the ones evaluated in the case of GMO: synthetic biology itself does not pose a risk but some individual organisms, components or products engineered using Synthetic Biology could pose risks due to the nature of the particular genetic changes. Those risks can only be assessed on a case-by-case basis, considering the modification, the organism, the environment and the interactions, as is already done with the GMOs.

3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

Any socioeconomic impacts assessment should assist in decision-making and not be considered in the risk assessment. As commented by Dr. Louter, it´s important to separate science-based risk assessment from other types of ‘technology assessments’.

In Brazil we have different steps for a GMO approval: an obrigatory risk assessment based on five main principles – stepwise approach, science-driven, case-by-case, comparative assessment and a interactive process and an optional consideration of socio-economic aspects for the final decision.

It´s also important to remember that even for GMOs there is little experience of countries applying socioeconomic considerations using reliable methodology. If there isn´t a robust assessment using the adequate protocols the decision could be used as a barrier to prevent the adoption of the technology based on speculative risks.

Best regards,
Luciana Ambrozevicius / Ministry of Agriculture - Brasil
posted on 2015-05-27 21:42 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7204]
Dear colleagues,

I would like to thank the moderator Casper Linnestad for kicking off the discussion. I look forward to an involved and interesting exchange of viewpoints.

My name is Jaco Westra from the Dutch National 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.

Basically, the three questions at hand are:
1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?
3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

As is put forward by several contributors to the forum already, these questions cannot be answered in a generalized way.  ‘Synthetic biology’ as a concept is just too broad and too versatile to allow for one single and comprehensive technology assessment.  That is, a case-by-case (or situation-by-situation) assessment is needed for all aspects of the technology assessment (benefits, risks, socioeconomics, ethics, legal)

To add to the discussion, as ‘synthetic biology’ as a concept is too broad, we might consider an approach in which we
a) try to come to some sort a subdivision of ‘synthetic biology’ in different categories or general fields of application, and
b) for each field of application/category we try to identify the approach/instruments needed to come to an assessment of the questions  1 to 3 (or a selection)

An approach like this might help us to get an improved understanding of where we lack the necessary knowledge and instruments to come to the needed assessments.

A subdivision might be: contained, vs non-contained combined with the classical division in industrial biotech (‘white’), medical biotech (‘red’),  plants/crops (‘green’). Although alternative approaches may be feasible and worthwhile to explore as well

Finally, some aspects that came to mind on which some further reflection might be needed
• Proliferation – the synbio techniques will become more accessible and common to use. In what way does this affects our current way of thinking on benefits and risks and methodologies we use to assess these aspects?
• In many cases a full assessment of the benefits/risks of a specific synbio application requires comparison with an already existing application (or route of production). E.g. comparing the risks/benefits of the production of chemical X  requires a comparison of the synbio route of production with the more conventional chemical route.
• ‘Biomolecules’ can be either a component or a product from synthetic biology. Whether the impact of these type of components and products can be assessed adequately and whether the current regulatory regimes provide a sufficient framework needs to be explored further.

Looking forward to our continued discussion,

Best regards,

Jaco Westra
National Institute for Public health and the Environment (RIVM), The Netherlands
posted on 2015-05-28 09:15 UTC by Mr. Jaco Westra, Netherlands
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7205]
POSTED ON BEHALF OF SATURNINA HALOS

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Dear colleagues,

I am Saturnina Halos, a molecular geneticist by training  and I have been acitvely involved in developing and monitoring the implementation of the regulatory policies in modern biotechnology in the Philippines since 1990. I would to comment on the following questions 

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?
3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

In answering the above questions posed by our coordinator, I agree with the comment of Jim Louter that the answers can be derived precisely through risk assessment for questions 1 & 2. The issues raised by organisms, components and products will differ. Living organisms will reproduce and removal from their environment is more complicated than with non-living products. I also agree that the principles currently used in assessing the safety of LMOs would apply for living products of synthetic biology. On the other hand,for non-living product,safety assessments will depend on the intended use for each product, e.g. pesticidal products are assessed in accordance with established procedures different from procedures for assessing veterinary products.  Still, the principle of case by case assessment applies to all products of synthetic biology but the issues addressed would differ.

As for socio-economic impacts, what we do in the Philippines is to conduct an ex-ante economic analysis for a proposed biotechnology product to be developed as the basis for deciding whether government funds will be invested in developing the product. This is not a regulatory action as it does not apply to private sector projects. It is difficult to include socio-economic considerations in regulation. People have a way of adjusting to new realities that is unpredictable. For example, one of the socio-economic issues previously raised in the Philippines against GM corn is that the seeds are too expensive that poor farmers cannot afford them. The thing is, our poor farmers are used to borrowing money for farming and non-productive activities like fiestas and weddings. More than 80% of them borrowed money for buying GM corn seeds and they are happy because with GM corn they do not accumulate debts unlike before.
posted on 2015-05-28 15:20 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7206]
Dear Participants, Secretariat and Dr. Casper Linnestad,

My name is Silvia Ribeiro and I am the Latin America Director for ETC Group. As a member of civil society, I have followed and participated in CDB negotiations–and some of its protocols–from its inception, with particular emphasis on social and economic aspects and how they relate to biodiversity.  I thank the Secretariat for organizing this forum and Dr. Linnestad for moderating this point.

I am concerned that peasants, indigenous and local communities seem not be participating in this forum (probably due to the technical language and the use of only English). Many of their perspectives seem to be absent, while industry is abundantly represented. Indeed, we were informed in one previous intervention that a representative of the Japanese biotechnology industry is representing his government and his trade association at the same time. This may raise some questions of which position is he presenting.  However, I am hopeful that moderators and the Secretariat will take these aspects into account, and take necessary provisions later in the process.

Many synthetic biology products currently in the pipeline will have serious negative social and economic impacts for thousands of peasant and indigenous communities, particularly those based in Asia, Africa and Latin America.  This is because the synthetic biology industry’s current focus is largely on replacing botanically-derived flavours, fragances and pharmaceuticals. These crops are currently produced by these communities, often using traditional knowledge and sustainable methods. This production provides hundreds of thousands of peasants and indigenous families with a much-needed cash income. This income in turn allows them to stay on their territories, and continue maintaining their livelihoods and cultural diversity, which, as Article 8J of the CBD recognizes, is  profoundly interlinked with, and fundamental for, the conservation of biodiversity.

The example of vanilla replacement illustrates the risks that synthetic biology poses for these livelihoods and the biodiversity they support. Although the majority of the vanilla flavour market has been taken over by chemically-synthesized products from vanilla industry producers, there are still around 200,000 peasants involved in the production of vanilla and cured vanilla beans. The majority are in Madagascar, Comoros, and Réunion, but significant peasant production of vanilla also takes place in Indonesia, Mexico, Uganda, Congo, Tanzania and Malawi, among others. Mexico is the centre of origin for vanilla, and communities here have a long and deep cultural connection with this plant and its uses. They are still caring for vanilla, and the forests where it grows,as both are interdependent.

Contrary to the arguments presented by Dr Hideyuki Shirae, from Japan Bioindustry Association/Government of Japan,  [#7199], the introduction of a  SynBio-produced vanilla flavour is intended to compete directly with (and potentially replace) the natural vanilla produced by peasants, not the chemically-synthesized flavour. The companies producing the vanilla flavour (Evolva SA and International Flavours and Fragrances) have stated many times that they will market the SynBio-derived vanillin as “natural” – either “vanillin from a natural source” or “natural flavour.” The price point for this SynBio vanillin is above the price of artificial vanillin but below that of genuinely natural (i.e. botanically-grown) vanilla. Their target market is food manufacturers who want to lower costs by misleading the consumer. By making natural claims on a synthetic product, they will be able to charge a premium price without the extra cost of sourcing real natural vanilla. In this way, they are looking to directly compete with truly-natural vanilla flavour being sold in the food and cosmetics market. While the biotechnology industry may claim, for public relations reasons, that their SynBio vanillin will replace artificial Vanillin, this claim does not stand up to economic scrutiny. Until Evolva and IFF agree to require users of their product to label their SynBio vanillin as “artificial,” they will be directly competing with natural vanilla producers.

Similar examples of SynBio industry that aims to replace peasant-produced, low volume and high value products, include saffron, artemisia annua, star anise, patchouli, babaçu, and other fragances, flavours and botanically-derived pharmaceuticals and oils. In ETC Group’s Submission to this process, we attached an expanded compilation of case studies examining the societal, economic and biodiversity implications of SynBio-derived compounds challenging existing botanically-sourced natural products. This compilation can be downloaded at http://bch.cbd.int/database/record.shtml?documentid=108014

The impacts are not only economic in nature. These synthetic biology products could also have negative impacts on natural, cultural and agricultural biodiversity. If peasant and indigenous communities are deprived their cash incomes for natural products, they will find themselves obliged to exploit forests and other ecosystems to survive. Others will migrate, condemned to urban poverty and abandoning the fundamental role they have played as stewards in these areas. The same communities that produce vanilla, saffron or artemisia also produce a diversity of food, and are stewards of local and unique crop varieties. Many of these communities play a vital role in the conservation of agricultural biodiversity. In many cases, the income from high-value crops is what makes their stewardship role economically viable.

Vanilla production provides a paradigmatic example of how social and economic impacts may adversely impact biodiversity conservation. Vanilla growing in Madagascar or Mexico, for example, occurs in agroforestry settings where rainforest both shelters the vanilla vines and provides a frame (tutor trees) for the vines to climb. It is widely recognized that vanilla cultivation aids rainforest conservation in enhancing the economic value of intact forests. When vanilla prices fall (as they do cyclically) it has been observed that vanilla communities in Madagascar are more likely to clear forest hillsides to grow hillside rice: a slash and burn approach that worsens erosion. At times when vanilla prices are high (as they are now) food companies may be more tempted to move to “fake” vanillas such as Evolva/IFF’s SynBio-derived vanillin, driving down prices for peasant vanilla producers.

A case-by-case approach has to be considered insufficient for anticipating impacts. Such an approach isolates the product from the context and the whole life-cycle impacts of the organisms, components and products of  synthetic biology, including socio-economic aspects. The resulting understanding would be exceedingly narrow and would hide many crucial potential impacts.

If their livelihoods and products are not protected as a collective, affected communities –which are the main biodiversity actors–would be probably too far away, arrive too late and and will not have the funds and other resources to defend themselves against these products.


On another note, I would also like to point that it is highly arbitrary to claim that synthetic biology products will not have impacts on health or biodiversity, because they are not “alive”. There are no studies, experiments or proof that can demonstrate this. On the contrary, accidents can easily occur in the production process. –e g Synthetic modified organisms could leak from fermentation tanks- with unknown interactions in the environment;  the components and products made by these microbes may trigger reactions in humans and animals that are unexpected and unpredictable.
posted on 2015-05-28 21:34 UTC by Ms. Silvia Ribeiro, Action Group on Erosion, Technology and Concentration
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7207]
Dear colleagues,
I would like to make couple of remarks.
First, some contributions on all four topics so far leave the impression that the analysis of social and economic effects of use of LMO and synthetic biology organisms and products is somehow less scientific than risk assessment. I believe this is certainly not true, as such analysis should follow sound methodology and be based on empirically established facts. Of course the methods of social and economic sciences are different from those of natural sciences but they follow the same general principles. As with the risk assessment, assessment of social and economic consequences requires some assumptions to be made and there is a certain degree of uncertainty.
Second, analysis of social and economic effects just like risk assessment is strongly context dependent and also should be carried out on a case by case basis. Some generalisations are possible, but that does not change the general approach.
Third, regarding the example of vanillin produced by yeast being marketed as “natural” or “from natural source”, we have typical example of misleading the consumers. And that is a serious issue not only in the case synthetic biology products. As far as I see it very highly purified vanillin is essentially the same regardless of its source –chemical synthesis, plant material, recombinant yeasts, etc. On the other hand vanilla from botanical origin used as flavour and fragrance is very different from pure vanillin and anyone how has had the chance to try high quality ice cream can testify.
Best Regards,
Nikolay
posted on 2015-05-29 10:16 UTC by Mr. Nikolay Tzvetkov, Bulgaria
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7208]
Dear all,
Thanks to the moderator for guiding this discussion.  My name is Boet Glandorf, and I work as a senior risk assessor in the GMO Office in the Netherlands for more than 15 years. Before that time I performed several field trials with plant-beneficial synthetic (genetically modified) biocontrol bacteria to study their potential environmental risks and their dispersal
So my answer should be seen from this perspective.

To answer the three questions posed:

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?

As already indicated by several participants of this forum, this question cannot be answered in a generic way. Potential benefits or risks should be considered on a case-by-case basis. Organisms obtained with synthetic biology, as LMOs, are not inherently risky or beneficial for biodiversity and human health. This will depend the new phenotype of the organism and their specific use. Considering potential risks, the subdivision in categories of application as suggested by Jaco Westra [#704] could be useful. Depending on the specific use of the organism (e.g. contained use, field release, gene therapy) the desired phenotype and the exposure to the environment can be quite different, which has consequences for the assessment of potential risks for biodiversity and human health. In my opinion this does not mean that exposure of synthetic organisms (or their genetic material) to the environment is a risk in itself, however, it should be assessed what the environmental (or human health) consequence could be resulting from this exposure. 
Considering potential benefits, it is clear that there are many beneficial examples (see report CBD Technical Series no. 82 on Synthetic Biology). But not all synthetic organisms are inherently beneficial or can be applied in a beneficial way. Their potential benefits should therefore also be assessed on a case-by-case basis.
With respect to non-living components and products derived or produced by the organism produced by synthetic biology the same principle applies: potential benefits or risks can only be assessed depending on the nature and specific use of the product. These components and products will have be assessed within the respective frameworks, as was indicated by Saturnina Halos [#7205].

3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?
Potential socio economic impacts of components, organisms and products of synthetic biology will depend on the specific case at hand. For each case, a specific impact assessment has to be perfomed. I agree with Jim Louter [#7202] and Luciana Ambrozevicius [#7203] in that an assessment of socioeconomic impacts should be separated from the risk assessment. 
As an example of this separation: in Europe it is decided that EU member states can refuse cultivation of GM crops on their territory based on socio-economic arguments, even if the GM crop is proven to be safe and is already authorizatised.
posted on 2015-05-29 10:33 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 7208 RE: Opening of the discussion on topic 4 [#7209]
Dear all,

I would like to thank Casper Linnestad to be the moderator of this forum.

My name is Martin Batic from the Slovenian Ministry of the Environment and Spatial Planning (MESP). I am the national focal point for the Cartagena Protocol on Biosafety. My background is in biochemical engineering and biotechnology. Over the last 15 years I have been involved in biosafety issues in Slovenia particularly in risk assessment and regulation of LMOs.

I have been following the discussion under this forum with much interest and thank to all who have contributed.

From the lively debate so far it can be sum up that either potential benefits or risks can be indeed for the conservation and sustainable use of biodiversity or human health. So, on questions posed in this section I am of the same opinion what indicated by several participants of this forum that there is no simple general answer because of many ubiquitous variables exists. Consequently, I suggest that step by step approach with the risk and benefit assessment on the case-by-case basis should be applied also in this field. It will, however determine potential risks and benefit which could be in certain cases vast either from organisms, components or products arising from synthetic biology.

On the top of that it is important that socio-economic considerations are also integral part, but separated from risk assessment (already suggested in discussion by [#7202], [#7203] and [#7208]) in evaluation processes of outcomes arising from “SynBio” techniques.
Best regards,
Martin
posted on 2015-05-29 11:25 UTC by Mr. Martin Batič, Slovenia
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7210]
Dear Casper, Dear all

I think that the questions posed here are way too general that is what makes a focused answer very difficult. I remember when I was assisting with capacity building activities relevant to LMOs I often got this question are GMOs bad or good? The answer would be: we need to conduct risk assessment based on the case to know whether the expected risks are likely to happen or not. As for unexpected effects we rely upon monitoring to be able to detect any change and try to relate them back.

However, in this regard I would like to highlight that risk assessment under the Cartagena protocol on Biosafety (CPB) does not apply only to LMOs but to products thereof as well. The protocol define the term products thereof in its annexes as processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology. The term of products thereof could be extended to include products of synthetic biology as well

I believe that the same general concepts of risk assessment present in annex 3 to the CPB namely;
- Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.
- Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.
- Risks associated with living modified organisms or products thereof, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
- Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.
Apply well to evaluating the risk of products of synthetic biology.

With regards to the issue of potential benefit expected from synthetic biology I have two comments:
- Talking about benefit is out of the scope of what we want to achieve here under this forum and the convention; we aim to protect biodiversity form negative effects that new technologies may produce and not to assess what could be the benefit of those technology.
- The benefit of the technology should be taken on a case by case base too and it depend on what this case if aiming to achieve. What is the problem that we are facing? Would this technology be able to solve that problem appropriately? What other options exist for solving the same problem?

Warm regards,
O.A.El-Kawy
(edited on 2015-05-29 13:05 UTC by Mr. Ossama AbdelKawy)
posted on 2015-05-29 13:03 UTC by Mr. Ossama AbdelKawy, Mauritania
This is a reply to 7210 RE: Opening of the discussion on topic 4 [#7212]
Dear all,

Thanks to the Secretariat for organizing another round of discussions on Synbio, as well as for guiding us to relevant sections of their excellent technical document. I would also like to thank Casper for agreeing to moderate this discussion.

Reply to Questions 1 and 2:

I agree with previous posting about the same general concepts of risk assessment present in Annex 3 to the CPB to assess the potential risks of Synbio organisms. I would also like to recall that the RA under the CPB includes assessing the risks associated with LMOs or products thereof (Annex 3, point 5) and so I believe that Synbio products and components should be included in RA.

Special attention should be given to the fact that these new products might pose extra challenges to RA. In a previous post, one of the participants shared the view of potential challenges in finding proper/suitable comparators. Synthetic biology also employs techniques for genome editing that might produce small target mutations (i.e. single nucleotide polymorphisms) and potential off-target mutations across the genome, which can be very difficult to detect and identify using current molecular analysis.

A case-by-case RA should be able to identify and evaluate the potential adverse effects of synbio products. However, some supporting technologies (page 16 CBD document), such as site-direct nucleases, have already relevant scientific literature records of knowledge gaps that could help develop further RA guidance. An example of such approach can be taken from the workshop on RNAi-based GM plants organized by EFSA (http://www.efsa.europa.eu/en/scdocs/doc/705e.pdf). EFSA regularly reviews risk assessment practices for GM plants in the light of experience gained, technological progress and scientific development.

Reply to Question 3:

I would like to echo Nicolay (post #7207) who clarified how socio-economic assessments are currently being performed. I recall that social sciences and their scientific methods are well established in worldwide academic communities and any attempt to dismiss their methods is, at least, unscientific. There are current discussions on social economic considerations under the CP umbrella (http://bch.cbd.int/onlineconferences/portal_art26/discussion_groups/) and I think that socio-economic issues might be even more relevant to synbio products due to their novelty (therefore no history of safe-use) and the many scientific uncertainties and knowledge gaps surrounding their supporting technologies.

Best regards,

Sarah Agapito
posted on 2015-05-29 17:14 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7213]
Dear Casper, dear all,

Thank you, Casper, for your opening remarks and instructions. Additionally (or interactively) to the three categories you have outlined, I would like to point at some additional levels and aspects, and perhaps some more detailed categories for addressing risks and potential benefits as outlined in topic 4. 
Below I outline the points that I think need consideration when (A) Identifying potential harm and risks and (B) Assessing risk and furthermore the need for (C) Collaboration across borders, disciplines and jurisdictions.

A) Identification of potential harm and risk
a) This should be done 1) separately and 2) in combination for all three categories: ie.  (i) organisms, (ii) components and (iii) products arising from synthetic biology techniques. Potential harm, risks and risk questions may change depending on whether it is an organism, compound or product. The latter has been pointed out by various participants on this forum.
b) It should be done for each and all the different aspects relevant to the mandate and the obligations under the convention and its protocols and should include the conservation and sustainable use of biodiversity; negative impacts on human health; food security; small scale farming systems (and their contribution to biological diversity and ecosystem function); livelihoods and related socioeconomic considerations; indigenous peoples and local communities, including cultural aspects.  Related to this are issues of water, land rights, land use change, micro-climate, genetic resources and intellectual property.
c) Identification of location /place/community of potential harm, as it might be outside the national boundaries of the party/non-party of production or the party/non-party of use. This would for example be the case where products of synthetic biology would be replacing -on the national or international market- the (natural) products of small farming systems elsewhere and/or negatively impact livelihoods, farming systems, food security etc. and related biodiversity and ecosystems. These could be oils, fragrances and flavours, medicinal substances etc.
d) Whole life cycle analysis: It is difficult to encompass the whole breadth of potential harm that can arise from the development, use or production of organisms, components and products arising from synthetic biology techniques.  It would thus be helpful to regularly produce full life cycle analyses to provide the data and insight where harm arises. For example, the issue of feedstocks. Where the production of oils through micro-organisms, here algae, requires the constant input of sugars – these sugars need to come from somewhere. Whether corn syrup or cane sugar, it will require land and inputs to produce them, which in turn may be linked to issues of water, soil, land rights, land use change, chemical applications – which in turn have the potential to negatively impact the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols.

B) Assessment of risk.
The overall risk assessment would be for all the potential harms identified above combined. It would however be made up of numerous specific risk assessments, such as under (a) above for (i) organisms, (ii) components and (iii) products arising from synthetic biology techniques done separately for all the different scenarios identified. 
In cases where an organism arising from synthetic biology falls under the definition of an LMO as defined by the Cartagena Protocol, the Articles, Annexes and provisions of the protocol should apply, as well as those of its Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The Cartagena Protocol though “only” covers transboundary movement, primarily intentional transboundary movement. It has reduced requirements (ie no AIA) for LMOs in transit or destined for contained use.
The Cartagena Protocol risk assessment however cannot suffice as the only risk assessment for LMOs arising from synthetic biology techniques, as (a) it does not cover domestic use or production nor (b) does it cover the same breadth of impacts as mandated by the COP decision(s) on synthetic biology.
The Cartagena Protocol also does not cover components and products arising from synthetic biology techniques (unless they should fall under the definition of LMOs).
Furthermore, as identified by parties to the Protocol, there is a need for further guidance for risk assessment and risk management of LMOs that are micro-organisms, including algae, and for LMOs that are produced through synthetic biology techniques. When performing a comparative risk assessment, there is a need for a ‘comparator’, which may not readily be available for organisms derived through synthetic biology – also pointed out by Nikolay Tzvetkov [#7201]. 
This means that at present there is insufficient risk assessment and risk management capability/capacity for organisms, components and products arising from synthetic biology techniques, regarding their impact on the conservation and sustainable use of biodiversity and related human health, socioeconomic and cultural impacts relevant to the mandate of the Convention and its Protocols;
Whilst some of the early tools and techniques of genetic engineering may have been around for about 40 years – as mentioned right at the beginning by Hideyuki Shirae [#7199] – I would like to underline that synthetic biology techniques, such as genome editing, epigenetic alterations (including external application of dsRNA), gene drive systems, metabolic pathway engineering – including photosynthesis engineering, cell free system applications, ribosome engineering, cell-membrane engineering, production of newly designed nucleotides (xeno-nucleotides) and amino acids, are qualitatively very different and a noticeable step change from previous methods and applications of genetic engineering.  This is particularly the case when overlaid with the notion of synthetic biology as a pure and rational engineering approach, that will make living systems controllable and predictable.  There is a serious knowledge gap that needs to be closed for reliable risk assessments, including assessing the assumptions of precision and predictability in living systems.

C) Collaboration across borders, disciplines and jurisdictions
Collaborations (across eg: borders, topics and disciplines) are essential to identify and understand the nature and place of potential harm and to assess risks over time and across borders, also to produce full life cycle analyses over time and across borders, to know which questions to ask and which indicator to use.

Finally, I would also like to share the concern voiced by Silvia Ribero [#7206] making us aware that peasants, indigenous peoples and local communities seem not be participating in this forum. This limits the input and knowledge contribution into this forum significantly. I wonder if the secretariat may find and share with us a way forward to rectify this situation.

With kind regards,

Ricarda
Federation of German Scientists
posted on 2015-05-29 17:28 UTC by Ms. Ricarda Steinbrecher, Federation of German Scientists (Vereinigung Deutscher Wissenschaftler)
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7214]
Topic 4: Potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols

Dear All,

Thank you once again for the opportunity to contribute and to Dr Linnestad for moderating this very important part of the discussion. I am Jim Thomas of the ETC Group - I have introduced myself  and ETC’s work in the previous round so will be mindful not to repeat  too much here. I would also like to commend the Secretariat for its work in compiling CBD Technical Series no. 82 on Synthetic Biology which is an excellent summary of some of the areas for consideration when we talk about risks or benefits.

In ETC Group’s view, developing the means to reliably assess the potential benefits and risks (including related health and socio-economic impacts) of Synthetic Biology is an urgent priority for the international governance system and participants should not shy away from that task.  The Outcome document from Rio+20 , the World We want’ recognized “the importance of strengthening international, regional and national capacities in research and technology assessment, especially in view of the rapid development and possible deployment of new technologies that may also have unintended negative impacts, in particular on biodiversity and health, or other unforeseen consequences.”

The CBD, with its SBSTTA and also the mandated involvement of local and indigenous communities through Article 8j, is better equipped than many other bodies to spearhead such anticipatory technology assessment incorporating broad and useful knowledges . I notice that a couple of the respondents so far have tried to (artificially?) distinguish between a narrowly framed risk assessment (terming that somehow ‘science-based’ - and i agree with Mr Nikolay Tzvetkov’s discomfort with this framing) and broader technology assessment approaches. In some cases  respondents such as Dr Shirae of  the japanese biotech industry seem to favor only the narrow  so-called ‘science-based’ approach and i was concerned to hear Jim Louter say that Canada doesn’t even bother to consider wider issues except in the context of its own economic development goals. Seperating out  and prioritizing a narrow risk assessment approach  from broader technology assessment appears to be  a strategy of deliberately choosing ignorance. The distinction is odd. In fact technical assessment of technologically-related risks (e.g. toxicity, biosafety) is just one tool in the broader  technology assessment toolkit and it would be strange indeed for any government that  cares about making sensible and just decisions for its people and biodiversity  to willingly choose to ignore and avoid other assessment approaches available. Some respondents have suggested that applications should only be assessed on a case by case basis and that it is not possible to assess Synthetic biology as a whole however the introduction of technology platforms such as Synthetic Biology do present systemic challenges and create major system-level upheavals and disruptions that  cannot be identified or  assessed if assessment is narrowly carried out only application by application (or “case by case”).

With this systemic level assessment in mind it is significant that even the World Economic Forum, usually a cheerleader for Industrial biotechnology, chose to list Synthetic Biology as one of the key ‘global risks’ for 2015 noting that “ The establishment of new fundamental capabilities, as is happening for example with synthetic biology and artificial intelligence, is especially associated with risks that cannot be fully assessed in the laboratory. Once the genie is out of the bottle, the possibility exists of undesirable applications or effects that could not be anticipated at the time of invention. Some of these risks could be existential – that is, endangering the future of human life” (WEF, Global Risks 2015 report - http://reports.weforum.org/global-risks-2015/part-2-risks-in-focus/2-4-engineering-the-future-how-can-the-risks-and-rewards-of-emerging-technologies-be-balanced/#box2.6).

I would take issue with Luciana Ambrozevicius’s claim that there are not reliable methodologies for assessing socioeconomic impacts. Social Science and Science and Technology Studies are well established disciplines and there is much much more methodological experience and historical data to draw on in tracking societal impacts of new developments than  in assessing novel synthetic biology organisms for safety risks.

As has been noted before, the heart of  Synthetic Biology’s disruptive potential lies in its ability to potentially upturn some systems of manufacturing  (e.g. for synthesis of what were previously botanical compounds ) while bolstering the viability of  other systems- Bruce Dannenberg alluded to this  his response as he described his companies business  offer as s “securing the constant supply of carbon atoms the industrial chemistry sector will continue to need for their production cycles”.  What we are witnessing is a shift in production patterns much as synthetic chemistry transformed global production economies in the 19th and 20th century. The historical comparison between Synthetic Chemistry and Synthetic Biology and lessons learned  is useful to frame our consideration of risks and benefits. Firstly a number of products of Synthetic chemistry  were later found to be directly harmful to biodiversity and health. This only became apparent as scientific understanding of health risks evolved and in time we came to understand that the synergistic and long term effects of some classes of synthetic chemicals could not have been predicted by narrow case-by-case risk assessment (e.g. endocrine disruption effects or  atmospheric impacts such as ozone depletion and increased radiative forcing from ‘greenhouse’ gases). Such new knowledge was vigorously resisted by entrenched industrial interests who at first tried to dismiss early observed problems as ‘unscientific’. It is for this reason that parties now wisely turn to the precautionary principle in management of both chemicals and biotechnology and it is why entire technology platforms and classes of products should be evaluated early and together wherever possible.

In the case of the safety (health or biosafety) of organisms, components and products arising from use of synthetic biology techniques an overly narrow assessment lens is unlikely to capture unexpected, synergistic, long term behaviors and effects. This is particularly important for Synthetic Biology - a field where the underlying metaphors and concepts for the field (DNA as programmable code, organisms as machines, gene regulation networks as ‘circuits’) are so highly speculative and mis-matched to biological reality that errors and unpredictable outcomes are more likely. The enterprise of trying to make life ‘engineerable’ to behave ‘predictably’ is only a goal not a reality. The likelihood of unexpected outcomes and ‘Black swans’ is much higher than other ‘engineering’ disciplines. Nassim Taleb et al have explored in some detail how top down engineering approaches in complex systems (especially poorly understood systems such as genetic systems) raise high risks of ‘black swans’  - that is unforeseen and unforeseeable events of extreme consequence (see Nicholas Nassim Taleb et al  “The Precautionary Principle (with Application to the Genetic Modification of Organisms), Extreme Risk Initiative Working Paper Series - available at  http://www.fooledbyrandomness.com/pp2.pdf )

Taleb et al further explore how the systemic risk increases significantly as the number of introduced transgenic traits increases. This is particularly pertinent to Synthetic Biology where  large scale and parallel automated genetic engineering platforms (such as MAGE - Multiplex Automated Genetic Engineering) combined with fast and powerful transformation techniques such as CRISPR-CAS9 and Gibson Assembly  are enabling private companies to sometimes generate tens to hundreds of thousands of novel engineered variants per day and more quickly move those into commercial settings. This is a step change from the more artisanal transgenic approaches of 20 years ago where organisms were also being crafted ‘case by case’. Today  the sheer volume and speed of introduction of novel organisms will create risks and stresses that cannot be evaluated ‘case by case’. We need multiplex and largely parallel assessment mechanisms to match the multiplex and parallel production systems! Such evaluation also needs to ask fundamental questions about the reliability and appropriateness of underlying ‘engineering’ metaphors and not accept highly speculative claims about predictability.

While health and safety risks  warrant significant attention for systemic level evaluation, the societal-level disruptions may even be more significant. Going back to the examplar of Synthetic Chemistry the early (and possibly larger) harms arising from Synthetic chemistry followed from economic disruption - the many thousands of growers of dyestuffs, flavors and fragrances who lost markets to synthetic chemicals and later lost lives through ensuing poverty and malnutrition. The representative of the Japanese biotechnology industry/japanese government noted that the current vanilla flavor market is mostly dominated by Synthetic Vanillin - a situation that results from very painful and dramatic dislocations in livelihood and culture for vanilla communities and remains a source of economic precarity for the 200,000 or so vanilla farmers who still remain and who are amongst the poorest farmers in the world. The introduction of a Synthetic Biology-derived Vanilla that will be misleadingly marketed as ‘natural flavors’ does no good for those farmers and just adds to that pressure of that existing historical injustice with a new threat. However this is only one of a number of  ’disruptive’ application arriving in the market.

As my colleague Silvia Ribeiro mentioned, ETC Group has begun to undertake both desk research (case studies) and participative work to understand the real extent of the disruptions to come, including possible biodiversity and health impacts, from the strategic decision by Syn Bio companies to attempt to synthesize and market replacements for natural products particular flavor and fragrance compounds including essential oils. In 2013 the global flavor and fragrance market was valued at $23.9 billion, and is expected to grow to over $35 billion by 2019. The industry is increasingly concentrated in the hands of four multinational firms – Givaudan, Firmenich, IFF and Symrise; they account for 58% of the global F&F market (2013). The top 10 companies collectively account for an estimated 80% of total industry sales (compared to 64% in 2000). At least six of the top 10 companies have entered R&D agreements with synthetic biology firms and the current wave of Syn Bio products are mostly in this flavors and fragrances area..
Although many commercially available flavors and fragrances are synthetic The Flavour and fragrance  industry  still depends on botanical sourcing for some of its most important molecules and  currently sources 200 to 250 different botanical crops grown on an estimated 250,000 hectares worldwide. Around 95% of these crops are grown by small-scale farmers and agricultural workers, mostly in the global South. An estimated 20 million small-scale farmers and agricultural workers depend on botanical crops sourced for natural flavors and fragrances.

Flavor & fragrance industry trade groups acknowledge that these botanicals are “highly important in terms of their socio-economic impact on rural populations and may also have important environmental benefits within agricultural systems.” Although  “essential oils are typically categorized as ‘minor crops,’ they are of major economic social and environmental importance to the communities that are involved in their production – and frequently represent the key cash crop (family income generator) in their farming mix that supports improvement in social indicators – notably health and education.”

For an indication of the scale of impact of disrupting flavor and fragrance markets consider the table below which is just a representative sample of some of the key essential oils on the market and excludes food flavors such as cocoa and soap and cosmetic ingredients such as coconut oil and squalane:

Essential Oils and Livelihoods in the Global South: Recent Examples

Country
Product / Area
Synthetic Biology R&D Target?
Estimated # of farmers/agricultural workers

Afghanistan - Saffron (Syn Bio target) -  6,000 farmers (Heart province)

Comoros - Ylang ylang (Syn Bio target) - 50-65 tonnes per annum (over half world supply)

Comoros - Vanilla (Syn Bio target) - 5,000 – 10,000 farm families

India  - Cornmint (for menthol) - 15,000,000 small farmers; / 45,000 tonnes per annum

India - Jasmine 80,000 – 100,000 farmers/workers

Indonesia - Patchouli  (Syn Bio target) 12,000; 1,200 MT per year (90% of world supply), value of ~US$70-100 million per annum

Iran - Saffron (Syn Bio target) - 65,000 pickers /growers

Bulgaria - Roses for rose oil (Syn Bio target) — 65,000 farmers

Turkey - Roses for rose oil (Syn Bio target)  12,000 farmers

Madagascar - Vanilla (Syn Bio target) - 80,000 farmers

Mexico  - Vanilla (Syn Bio target) - 10,000 farmers.

Indonesia - Citronella (challenged by Syn Bio Nootkatone) - 10,000 farmers

China  - Citronella (challenged by Syn Bio Nootkatone) - 20,000 – 30,000

China -  Artemisia (Syn Bio target) - 100,000 – (approximately 300,000 worldwide)

China - Star anise for shikimic acid (Syn Bio target) - Guangxi province some 350,000 ha devoted to the star anise tree; annual output of 80,000 tonnes.

Haiti - Vetiver (Syn Bio target) 30,000 farmers.

Egypt - Geranium oil  - 150 to 180 tonnes valued at around US$15 million per annum

Egypt - Jasmine - 5,000 flower harvesters; 30,000 employed by jasmine industry ($6.5 million export value

France -  Lavender  - 1,500 farm producers & 30,000 full-time jobs

While the table above emphasizes livelihood disruption, it could also have been calculated in terms of potential land use change from lost crops ( land use change is a major driver of biodiversity loss, also greenhouse gas emissions)  or in terms of lost genetic diversity, since farmers are also conservers of agrobiodiversity. Livelihood disruption and loss of income may also be closely tied to health and mortality outcomes since Poverty is the leading determinate of poor health. Once again, as noted by the WEF,  a narrow  lab-based (‘science-based’?) risk evaluation of a synbio product or organism cannot by itself determine these system-level negative impacts.

Understanding real  impacts of these disruptions will require empirical studies and participative research involving those communities who are most affected as well as a critical stance towards speculative claims of benefits made by developers of syn bio applications (see Thomas, J  “Constructing a ‘futurology from below’: a civil society contribution toward a research agenda” Journal of Responsible Innovation 02/2015; 2(1):92-95. DOI: 10.1080/23299460.2014.1002176).

To this end, my colleague Marianne Bassey recently spent some time with Vanilla, Artemesia and Stevia farmers in East Africa trying to understand from their perspective how economic dislocations from the introduction of Synthetic Biology might concretely impact their lives.  Since there appears to be few (no?) farmers, indigenous people or in situ conservers of agrobiodiversity on this electronic forum i thought it might be appropriate to leave some of the comments relayed to us by Kenyan Stevia farmers when we asked what they would like to convey to United Nations bodies looking at this topic. Syn Bio Steviosides are being introduced to the market in 2015/2016 by Evolva and Cargill as well as by  DSM.

best
Jim

Paul Mwangi Kigaa , Stevia Farmer, Kenya:

He said the farmers are the ones that produce the natural stevia.  They do not want products that will cause health challenges.  He said these companies producing synbio stevia maybe using a lot of chemicals and it may cause some health challenges.  He does not think these companies produce their stevia in an organic way. He said synbio Stevia is not natural.  If there is a way to stop these companies from carrying on with this venture, he would happy if they are stopped. He said the production of stevia is labour intensive, the farmers toil to produce and also make a living from it; They want to continue in the way they have been growing stevia without disruptions from these foreign companies. His message to UN:  ‘...those who are concerned should stop the companies growing stevia in their factories, because it will affect our lives.’   He enjoins the UN and Groups to fight for them (farmers) and make sure it is stopped.

Harun Ngige Kamau, Stevia farmer Kenya:

He said he wants to appeal that they get good price that would improve their livelihoods.   He said synbio stevia would disrupt the price the farmers get for their stevia to meaningless point. ‘It will destroy the livelihoods around here and the economy and hope will be taken away from educating their children and also other ways.’
They want to appeal to anybody that has the power to stop the European companies from going ahead with the production of synbio stevia to really reconsider their actions and stop its production.  According to him ‘it is a crop that is going to be very meaningful to smallholder farmers and make our lives better. So why should the European Companies be so greedy and take that money alone whilst it can make a big difference in our lives.”


Ann Nduta Kanini, Stevia Farmer Kenya

She wants groups to appeal to the foreign countries producing stevia to stop them from competing with them - small-scale farmers. She said if these companies seize the market she cannot sell her product.  ‘ They are using machines and I am using my hands’
She wants  to appeal to the UN to look at the price and to look at products not using chemicals.
‘Stevia means a lot to me. There are no chemicals we use in growing it in Kangagawa. I admire it.’ She they should  be assisted and promoted.
posted on 2015-05-29 19:18 UTC by Mr. Jim Thomas, ETC Group
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7216]
Dear participants,
I’m Dr Lázaro Regalado from National Center on Biosafety, Ministry of Science, Technology and Environment, Cuba
I would like to thank Casper Linnestad for moderating this topic in the on line forum on Synthetic Biology.
Distinguished experts to this forum, the benefits arising for the use of synthetic biology is a fact that we should take into serious consideration as an emerging technology, the examples are many for the time being and with great potential to develop new and wide benefits. On the other hand the preamble of the Convention on Biodiversity, stated:
¨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,¨

In the context of the CBD, sustainable use is defined as “the use of components of biological diversity in a way and at a rate that does not lead to the long-term decline of biodiversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations”(Art. 2). Sustainable use encompasses ecological,economic, social, cultural, and political factors (Glowkaet al. 1994).

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.

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.)

Synthetic biology is one of the most dynamic fields of the life sciences and
may pose potential risks to the environment and human health. The establishment of regulations is a need at national and international level, including in the framework of the Protocol, a task not easy but possible.

Respectfully,
Dr Regalado
posted on 2015-05-31 04:30 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7217]
Dear colleagues and moderator Casper,

Thank you for the opportunity to participate in this Forum and share views with this remarkable group of experts.

I would like to draw the attention on Part I potential impacts of synthetic biology on biological diversity, Section 6: General Biosafety Concerns. Synthetic biology, Technical Series No. 82.

This section focuses on biosafety concerns related to the accidental or intentional release of organisms resulting from synthetic biology. These include concerns related to ecosystem-level impacts, gene flow, and the emergence of unpredictable properties
¨There is significant disagreement over how stringent physical containment measures should be for synthetic biology, stemming from disagreement over
the seriousness of the threats posed by organisms resulting from synthetic biology techniques (EGE 2009; FOE et al. 2012; Garfinkel et al. 2007, Marlière 2009). Requiring synthetic biology research to take place only in BSL 3 or 4 laboratories would significantly restrict synthetic biology research to a few laboratories(Garfinkel et al. 2007).

As I said in a previous intervention to deal with these issues first of all we have to try to answer some indicative questions in order to clarify, the scope and the objectives as a first step to look at the goal, for Instance:

*¿Are we dealing with confined organism, the released ones or both?
*¿Are we talking about the possibility of an unintentional release from the contention or an intentional one, or both?
*¿Are we going to deal with the organism, the products ….or both? 
*¿Is a policy of containment enough to avoid accidental or intentional release of organisms resulting from synthetic biology?
* …..

Of Course, the answers to these or other questions in this regard are not so simple, could have different approaches, agreed or disagreed. Then the issue of contained use should be properly identified and evaluated.

The containment with regard to biological agents in general is a field well known by biosafety professionals with national and international organizations working in this field, governmental and not governmental1*. The issue on biosafety is close related with a relative new field: The Biosecurity and in practical terms the Biorisk comprises both and in my opinion with 28 year of experience in this field is that we have the tools in this discipline to deal with the specific issues of contained use, accidental release, intentional release or other non-peaceful purposes more related with facilities where take place research or production. The biosafety principles are applicable as well as the Biosafety levels, specific risk assessment’s techniques, approaches and risk managements, the assistance of WHO and other organizations related with animals and plants with facilities working with SB could be useful as well as governmental specialists  with expertise in the area.

I would like to point out that the risk assessment is the corner stone in deciding the biosafety level where the research activities on SB and later on the production, take place, it means that not necessarily the Biosafety level 3 or 4 most be used, at least that the risk assessment indicate it.

In other words, 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)

“Contained use”, as defined in the Cartagena Protocol on Biosafety, article 3:
Means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.

¨There is significant disagreement over how stringent physical containment measures should be for synthetic biology, stemming from disagreement over
the seriousness of the threats posed by organisms resulting from synthetic biology techniques (EGE 2009; FOE et al. 2012; Garfinkel et al. 2007, Marlière 2009). Requiring synthetic biology research to take place only in BSL 3 or 4 laboratories would significantly restrict synthetic biology research to a few laboratories(Garfinkel et al. 2007). Principles for the Oversight of Synthetic Biology, collaboratively drafted by civil society groups and endorsed by 111 organizations, calls for the strictest levels of containment of synthetic biology (FOE et al. 2012).¨

1* ABSA: American Biological Safety Association 
   IFBA: International Federation of Biosafety Associations.
   CDC: Center for Diseases Control and Prevention
   WHO Biosafety Manual, third edition Geneva, 2004.
   
• Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories. MMWR / January 6, 2012 / Vol. 61
• ARS Facilities Design Standards. Manual 242.1, May 1st 2012. United States Department of Agriculture.
• Design Requirements Manual for Biomedical Laboratories and Animal Research Facilities (DRM) The Division of Technical Resources (DTR) National Institutes of Health (NIH), 2008.
• CWA 15793:2008, Laboratory biorisk management standard.
• CWA 15793: 2011 Laboratory biorisk management standard
• CWA 16393: January 2012 Laboratory biorisk management - Guidelines for the implementation of CWA 15793:2008
• UNE-CA 15793: Julio 2013 Gestión del riesgo biológico en el laboratorio. AENOR. Asociación Española de Normalización y Certificación.
• UNE-CA 16393. Junio 2014. Gestión del Riesgo biológico en el laboratorio. Guía para la aplicación del CWA 15793:2008.ç
• Canadian Biosafety Standards and Guidelines First Edition/2013. http://canadianbiosafetystandards.collaboration.gc.ca/
• Biosafety in Microbiological and Biomedical Laboratories. 5th Edition. HHS Publication No. (CDC) 21-1112. Revised December 2009.
• Biosafety Risk Assessment Methodology. Caskey S and et al. Sandia National Laboratories. Albuquerque, New Mexico, California. October 2010. On line order: http://www.osti.gov/bridge
• Bio-Riesgo Intrínseco Mínimo: Un método para la evaluación del riesgo causado por agentes biológicos. Antonio Rubén Jarne y Nidia Fátima Ferrarotti. Laboratorio CMS. Secretaría de Salud Buenos Aires, Argentina.
• Development of Particle Tracer Techniques to Measure the Effectiveness of High Containment Laboratories. A. M. Bennett, et al.. Applied Biosafety, 10(3) pp. 139-150 © ABSA 2005

Respectfully,

Dr Regalado
posted on 2015-06-01 00:16 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7218]
Dear Colleagues, 

In follow up of my previous reaction (#7204) I would like to add some additional thoughts to the discussion.

As stated by Mr Regalado (#7217) to answer the questions on risk and benefits (environmental, human health, socio-economic, ethic, legal) - we will need to come to some sort of operationalization of these questions.

A. Operationalization of the questions
When looking at, for example, synbio organisms additional fine tuning along the line of confined use, accidental release, deliberate release  etc. might indeed prove useful to come to a better understanding of how to further evaluate the questions on risks and benefits and which instruments and knowledge is needed to make such an assessment. 

A key element  in such an approach is that we need to look at it from the application perspective: that is the basis will be a case-by-case (situation-by-situation) approach as already put forward by a large number of partcipants. We could however consider the possibility to add an extra layer of abstraction to this case-by-case approach, e.g. by looking at certain types of application (e.g.  biosensors, semi-contained algae, medical applications, probiotics, etc), instead of the actual individual application. An approach like this could helps us to get an overall better understanding.

B. Life cycle approach
Additionally, as a general thought, some sort of life cycle approach could be useful when looking at the risk/benefit question (as also suggested by Ms. Steinbrecher; #7213) .  This best exemplified for e.g. the production of chemicals through synbio routes. By looking at the complete lifecycle of the production of chemical X - an overview of the overall impact in all seperate life cycle stages can be obtained. An additional advantage is that it allows for comparison among different production routes (chemical, synbio, other).  Within the lifecycle methodologies many variants exists - varying in the level of abstraction and the parameters/issues taken into account.

Approaches like these, are necessary as they provide insight in the complete process and look further then the final product stage of an organism/component/product. Also, information on the impact of synbio on a more 'systemic' level is obtained.

C. Risk Assessment methodologies
For the assessment of risk several frameworks are available. For LMO's the current frameworks are judged to be applicable according to e.g. a recent report of the European Scientific Committee on Emerging and Newly Identified Health Risks.  However, the speed of development in the field and the ongoing innovation does demand a close monitoring of the field and validity of the risk assessment methodologies and instruments.

Similarly, for the risk assessment of chemicals (synbio products) well tested and developed frameworks exist.  However, the legal framework in the EU such as REACH (Registration Evaluation and Authorization of CHemicals) - which encompasses a highly sophisticated risk assessment methodology -   does have specific legal boundaries which need to be considered.  Low volume (1 ton/year) production chemicals e.g. are only covered to a bare minimum. The consequence of this is that the methodology to assess the risks will be available but the actual data needed to do this assessment will most likely be not, as there is no incentive to generate them.

Kind regards,

Jaco Westra
National Institute for Public Health and The Environment (RIVM), the Netherlands
posted on 2015-06-01 09:24 UTC by Mr. Jaco Westra, Netherlands
This is a reply to 7218 RE: Opening of the discussion on topic 4 [#7221]
Dear All

My name is Christoph Then. I work for a German NGO called Testbiotech.

There were three questions raised under Topic 4 and a further question raised under Topic 5, and so in response to those questions I would like to introduce an “organism” into the debate that might prove helpful in further discussion and in seeking answers:

The “organism” is to some degree hypothetical, but very much based on current technology. It is an insect, a fly that in its native form causes problems in agriculture in the same way as fruit flies or olive flies. Created through synthetic genetic engineering, it carries artificial DNA that kills female offspring but enables male offspring to survive (in a similar way to the flies produced by UK company Oxitec). Further, its synthetic DNA is meant to act as a gene driver, changing the pattern of heredity in order to spread more rapidly into native populations (Gantz & Bier, 2015).

I believe that an organism such as this should come under the definition of a synbio-organism. Changes in the genome would be much more radical than in any previous transgene species, and it would be difficult to create without the means and tools of DNA synthesis. One could, however, even suppose that a whole chromosome containing the artificial genetic information had been inserted into the insects (as it was done on yeast, see Annaluru et al., 2014).  

The “organism” could now be deliberately released into the environment in large numbers.

The benefits of this scenario would be a decrease in populations of flies which are, for example, regarded as a major economic threat to agriculture in Mediterranean countries. So if everything goes to plan, the farmers might use fewer and less insecticides and have a higher income.

But the down side would be the numerous environmental risks. If the technology were successful it could lead to the extinction of the fly species. Thus, biodiversity would be lost, with various potential consequences for the environment, food web etc. If the technology were only partially successful, the artificial genes would end up permanently in the native populations, from where they might spontaneously cross boundaries and come into contact with a wide range of environmental conditions (in the whole of the Mediterranean area), be expressed in various genetic backgrounds (there are genetic differences in the regional varieties of the flies) and be exposed to environmental stressors such as climate change. No matter which specific perspective we have on the technology, we have to agree that the predictability of such a scenario is very, very low. So any risk assessment would necessarily suffer from a substantial amount of non-reducible non-knowledge (see Boeschen et al, 2006).

The negative socioeconomic impacts would be, for example, that organic farmers might not be able to avoid their products coming into contact with these flies, and therefore their food products might even contain the biotech-larvae. Markets could be lost as a consequence – and in an extreme scenario, the whole of the harvest in the Mediterranean area could be affected if consumers reject this technology.

Coming to the question of best practice in performing risk assessment, it does not make much sense to perform detailed risk assessment on such an insect, because its biological properties would be hard to compare with existing organisms, no clear hypothesis could be formulated to identify the most relevant risks. Thus, we might not be aware of any evidence that these flies pose specific risks at the time of their release. At the same time, however, we would have to admit that we are not able to assess the risks in a way that allows us to come to any conclusions upon the long-term safety of such an organism since any spatio-temporal control is missing.

As a result, under best practices on risk assessment, it would be necessary to define clear cut criteria for such organisms in order to make a distinction between an organism that can undergo risk assessment and those organisms that cannot be assessed properly, and should under no circumstances be released.


Annaluru, N. et al. (2014). Total Synthesis of a Functional Designer Eukaryotic Chromosome. http://www.sciencemag.org/content/early/2014/03/26/science.1249252.abstract

Boeschen S., Kastenhofer, K., Marschall, L., Rust,I., Soentgen, J., Wehling, P., (2006) Scientific Cultures of Non-Knowledge in the Controversy over Genetically Modified Organisms (GMO) The Cases of Molecular Biology and Ecology, GAIA 15/4: 294 – 301

Gantz, V.M., & Bier E. (2015). The mutagenic chain reaction: A method for converting heterozygous to homozygous mutations. Published Online March 19 2015, Science DOI: 10.1126/science.aaa5945
posted on 2015-06-01 20:27 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 7216 RE: Opening of the discussion on topic 4 [#7223]
Dear All,

First I would like to thank our moderator Casper Linnestad, to moderate this topic in the online forum in Synthetic Biology.

We consider that organisms, components and products derived from synthetic biology techniques could have undesirable effects on health and biodiversity coinciding with the document of the Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82 118 pages.

According to art.16 of the Cartagena Protocol, which states that measures based on risk assessment will be imposed to prevent "adverse effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health..." , likewise it must address cultural, socioeconomic, ethical aspects and the relationship of balance and complementarity that man has with Mother Earth, should also keep in account the protection and preservation of the centers of origin and centers of genetic diversity the fair and equitable distribution of benefits, the role of indigenous peoples and local communities.

Under that framework and in accordance with the precautionary principle, it is important to take into account the sustainable use of biodiversity, understood as the use of components of biological diversity in a way and at a rate that does not lead to long-term decline of biological diversity , thereby maintaining its potential to meet the needs and aspirations of present and future generations (CBD Article 2).

It is essential to establish international regulation to ensure the protection of the life systems of Mother Earth.

Best regards,
Sorka Copa Romero
Bolivia
posted on 2015-06-01 22:05 UTC by Ms. Sorka Jannet Copa Romero, Bolivia (Plurinational State of)
This is a reply to 7221 RE: Opening of the discussion on topic 4 [#7224]
Dear Casper, Dear All
Thank you very much for these important discussions which allow to learn enough on synbio organisms
In this context, the risk assessment needs knowledge and experience by using existing scientific tools and the case-by -case approacn as suggested by many participants will be applicable with Socio-economic impact criteria
Kind regards
Gado
posted on 2015-06-02 09:39 UTC by Mr. Mahaman Gado Zaki, Niger
This is a reply to 7224 RE: Opening of the discussion on topic 4 [#7225]
Hello, I am Hilary Sutcliffe, from MATTER in the UK, a think tank focusing on 'Responsible Innovation'. 

The issues raised by Jim Thomas of ETC and Christoph Then from Testbiotech, in particular about wider social and ethical impacts, and the probable unknowability of cumulative effects are really important.   Some on the thread seem to say that this is not the remit of this group, that a narrower eco risk assessment is its focus.  

I was pondering how best to look at these areas in more detail as I feel they may be noted here, but because they don't quite come under its remit, could be ignored.

Perhaps could we have separate threads on social impacts and cumulative effects among others so that we can look at them closely in their own right, rather than try to wedge them in an area where there may not be the will or space to include them?

On social impacts for example, a richer picture of trade offs & effects can also be brought into discussion (for example someone talked to me yesterday about labour standards in the fragrance industry production side in which they welcomed synbio as a much less 'dirty' and dangerous approach for workers in factories, though others are concerned about its impact on jobs.)

I would also be interested in the mechanism for saying no to one or other solution - for example who's job is it to prioritise - personally I can't see farmers livelihoods trumping any commercial imperative if it is large enough, but I can't also see the process we could adopt even if we did want to say no except for Jim mounting a big campaign and people giving in to the pressure.

It is the practicalities of all this, not just the theories and the issues I am keen to explore.
posted on 2015-06-02 10:29 UTC by Ms. Hilary Sutcliffe, MATTER
This is a reply to 7225 RE: Opening of the discussion on topic 4 [#7227]
My name is Genya V. Dana, Senior Science Policy Officer in the Office of the Science & Technology Adviser to the Secretary of State, at the U.S. Department of State, and it is a pleasure to continue to participate in this online discussion.

The United States supports research and development for innovative applications of biotechnology, both at home and with partners around the world. The United States understands synthetic biology as it is discussed in the research and development community to encapsulate a continuum of biological engineering tools and techniques leading to progressively advanced biotechnology products. Over forty years of research, education, and product development using recombinant DNA techniques have led to clear benefits relevant to the Convention’s objectives, and these benefits will continue to emerge with continued application of biological engineering tools and techniques. For example, recombinant human insulin was first licensed in 1980 and is now used worldwide to fight diabetes in humans. Medical research with transgenic mice and other organisms has enabled the elucidation of diseases and therapies for humans and animals. Modified plants have improved crop production methods with a number of benefits, including reduced soil erosion, decreased use of chemical pesticides, new disease-resistant varieties, and improved farm productivity and farmer income. We note that a great deal of the biological engineering research and development in the United States is aimed at reducing dependence on petroleum products, which often serve as the primary substrates for production of many important chemicals and fuels. 

The Cartagena Protocol recognizes the need to consider potential adverse effects LMOs may have on the conservation and sustainable use of biological diversity, taking also into account risks to human health. Nevertheless, great care should be exercised when drawing linkages between the products of biological engineering and potential risks and benefits to biodiversity and human health. As others have noted, there can be no simple, general answer to this question. Peer-reviewed, independent studies should provide the basis for statements on risks and benefits to biodiversity and human health. However, we are of the opinion that the absence of information should not stop innovative research and development from proceeding, in accordance with applicable regulations and international obligations. The United States supports the internationally accepted approach of taking the least restrictive measures possible to achieve reasonable safety objectives, in the absence of evidence of likely harm.
posted on 2015-06-02 13:34 UTC by Ms. Genya Dana, United States of America
This is a reply to 7206 RE: Opening of the discussion on topic 4 [#7228]
Dear Participants, Secretariat, Dr Casper Linnestad, and CBD observers,

My name is Stephan Herrera. I am VP, Strategy & Public Affairs at a small Swiss-based company called Evolva (http://www.evolva.com). As a member of civil society, as well, who also has observed and participated in CBD meetings, I welcome the opportunity to address concerns about our products and science—and the concern that industry views are abundant. I sincerely hope that my responses will be viewed by all on this forum in the spirit in which they are given because my aim is not to polarize or demonize, but rather to present the facts that are needed before decisions/conclusions are made.

Industry representation on this forum: Let me first address this point that industry is over-represented in this forum. It does appear that industry and academe are now engaged in this dialogue on synthetic biology like never before. It should be pointed out that up until now, quite the opposite has been true. Indeed, up until now, the number of individuals from industry and academe who have in good faith attended COP-MOP meetings around the world is a tiny fraction of the number who have been engaged from the outset in this effort to paint synthetic biology in stark black terms. Moreover, at the COP-MOP proceedings and “side meetings” that I have attended, I have never seen anybody from industry or academe distributing pro-synthetic biology lobbying materials to CBD delegates or stacking hallway tables outside of these meetings with daily persuasion flyers. For better or worse their numbers have been small and their presence at COP-MOP events comparatively invisible.

The trajectory of “impact”: Intellectually honest and ethically grounded ruminations and predictions about the future impact of biotechnologies are hugely important—and should be considered here not as something that is sorely needed, but rather as something that already exists. There are myriad reports from bioethicists and environmental impact experts, for example, that have been commissioned and published on the topic of synthetic biology, past, present and future. Government researchers in many countries have analyzed the topic and produced reports, as well. (For better or worse, notably absent from this canon are industry funded or influenced reports.) The potential for synthetic biology to be leveraged to do good vs do harm has been measured and calculated by these neutral third parties. Their consensus findings suggest that the potential to do good vastly outweighs any potential risks. As there certainly should be, the authors of these reports call for continued oversight by the biotechnology protocols that already exist.

There is simply no evidence to support the assertion that “synthetic biology products currently in the pipeline will have serious negative social and economic impacts for thousands of peasant and indigenous communities, particularly those based in Asia, Africa and Latin America”. So, let us call it what it is, a prediction. If we are to have an intellectually honest discussion about synthetic biology, we need to be intellectually honest in the language we use to communicate with each other.

Synthetic biology “industry”: As has been pointed out with limited emotion and abundant facts in the Topics 1-3 discussions, synthetic biology occupies the genetic engineering branch of biotechnology. There is no such thing as a synthetic biology “industry”. Assertions to the contrary are largely fueled by market research consultants—and those who have discovered that they can more readily exploit the lack of awareness in the public about synthetic biology with a deeply polarizing premise and a demonizing narrative.

Target markets: Biotech products produced from biotechnology and fermentation are not focused on “replacing botanically-derived flavours, fragances and pharmaceuticals”.

This “replacement” premise ignores the fact that as a company selling to consumers, if you have a high-priced, premium product whose branding depends upon the image, quality, and geographical location of a particular botanical ingredient, you’re going to continue sourcing it from the plant. On the other hand, up until recently, by and large, if a producer needed a particular ingredient for a low-priced, mass-market product, they had no choice but to source it from a synthetic, petrochemical-based source. With few exceptions, producers of mass-market products do not directly (or even indirectly) source their ingredients from small farmers. It’s been that way for generations. They source their ingredients from chemical companies or large, industrial-scale agriculture.

In the eyes of the high-end product producers, biotechnology and fermentation are not viewed as an alternative to botanicals. There is no evidence that high-end producers have or will in the future show any intention of switching. A 60-second phone call to any high-end product producer that has been sourcing botanical ingredients will confirm this point.

In the eyes of mass-market product producers, our ingredients are being viewed in comparison to ingredients sourced/processed from petrochemicals, invasive weeds, industrial-scale agriculture, and (illegally) from endangered plants and animals. Or they are creating new markets that cannot be addressed by existing approaches (f.x. Reb D).  If there is any disruptive impact it has been/will be felt by large North American, European and Chinese enterprises. A 60-second phone call to any mass-market product producer will confirm this point.

Thus, in addition to this “replacement” targeting allegation being dead wrong, this effort to craft a David vs Goliath dichotomy does nothing to inform or enlighten those in the CBD who have worked hard to better understand synthetic biology impact scenarios. It is a polarizing and demonizing maneuver that badly misinforms the public and stokes cynicism and fear of biotechnology.

Vanilla vs vanillin: Vanillin is the principal flavor and aroma compound in vanilla. Cured vanilla pods contain only 2% vanillin by dry weight. The vast majority of the world’s supply of “vanilla” flavor and fragrance has for generations been supplied by vanillin, not vanilla. Almost every ounce of vanillin is made from petrochemicals and wood pulp.

From a taste and fragrance standpoint, vanilla from the orchid is the superior product. But, because vanilla is massively (c. 100x) more expensive than synthetic vanillin, and because it requires a lot of land and water, and because its supply chain vulnerable to weather and transportation disruptions, industry turned to “synthetic” vanillin many decades ago. Vanilla from the “bean” is used only in premium products. The reason it is so incredibly expensive is because it is a fragile plant that makes it highly vulnerable to disease. The orchid pollinates but once per year, and this must be done by hand (since the vanilla orchid is not native to Madagascar or Indonesia it lacks natural pollinators in these countries).

Japan’s Dr Hideyuki Shirae is correct that our product competes with vanillin from petrochemicals and wood pulp, not the high-cost vanilla from the orchid. After all, why would any company target a 1% segment of the market when the vastly more economically attractive and value-proposition narrative in the 99% slice offer a night-and-day better market opportunity?

Although this point is well known by anybody in the vanilla industry, small farmers in Madagascar, Mexico, Tahiti, Uganda, Indonesia, PNG and elsewhere sell into the high-end vanilla “bean” market. They do not sell into the massively less profitable vanillin market. Why would they?

As we have said before, we’re not sure why anybody who cares about biodiversity, sustainability and environmental progress would want the food, beverage and fragrance industries to continue to source their vanillin from petrochemical companies and paper mills instead of from our ingredient. But, this is clearly what critics are proposing. There is clearly a disconnect here.

Natural Vanilla vs Natural Vanillin: There is also this notion that our vanillin will sneak its way into the food chain as “natural vanilla”. It won’t because it cannot. The laws governing vanilla and vanillin labeling are very strict, both in Europe and in North America where the vast majority of vanilla essence and fragrance ends up. As any producer will tell you, our product will never be marketed to food, beverage, or fragrance producers (we do not market directly to consumers) as “natural vanilla” or “vanilla” of any sort, full stop. The (existing) law is clear on this. Moreover, as UN data (the FAO) and any orchid-based vanilla importer in Europe or North America will confirm, demand for vanilla from places like Madagascar is solid and has thankfully not been affected by the misinformation (see Slate article below). And there is this: the industry that sources vanilla has known for several years that our product was coming. Neither the anticipation or the market launch of our vanillin product have affected demand for vanilla. Indeed, as a leading vanilla importer recently told the Guardian, “We see a long-term demand for our products that is not going to disappear, regardless of technological innovations that may come along.” http://www.theguardian.com/sustainable-business/2015/may/28/creators-defend-vanilla-flavour-made-using-synthetic-biology?utm_source=twitterfeed&utm_medium=twitter


PR maneuvers: It needs to be said here on this forum that the misinformation that continues to presented as fact on this topic of labeling, market segment targeting, and “vanilla vs vanillin” does nothing to advance the discussion on synthetic biology. It only adds to public confusion and cynicism about biotech in countries that actually suffer from those who seek to distort the truth about risks vs the promise of science and technology.

PR schemes like the one hatched against us vis-à-vis Haagen-Dazs are, among other things, equally unhelpful. For those of you who are aware of this PR maneuver, a few groups opposed to synthetic biology launched a campaign against our vanillin product and sought to pressure companies like Haagen-Dazs, which have premium-priced products that use “Madagascar vanilla” in their branding, to public proclaim that they will not switch to our product. Why would they? Indeed, that is exactly what Haagen-Dazs told the campaigners. However the campaigners manipulated the statement from Haagen-Dazs and proclaimed victory, and a number of media outlets bought it. It was only after more mainstream reporters went directly to the company to get the facts directly from Haagen-Dazs that the misinformation ruse was exposed for what it is.

I ask you, how exactly does Madagascar benefit from these efforts to sow public confusion about vanilla? Worse, the reckless disregard for the truth and knowledge of the misinformation is malicious exploits the gap in knowledge of both synthetic biology and the vanilla-vanillin market. We have, by the way, on multiple occasions confronted all of those who continue to foist this fraud upon the public and in the media, and asked them to stick to the facts and leave spin and hype to the PR firms. There is no interest on their part for dialogue or pivot. In fact, the more make efforts we make to engage these groups, the more we become a target in fora like these. This has a chilling effect.

And the media is starting to become wise to this vanilla-vanillin ruse and has started to expose it as such. Slate http://www.slate.com/blogs/future_tense/2014/09/04/no_one_should_be_afraid_of_synthetic_biology_produced_vanilla.html and National Geographic http://theplate.nationalgeographic.com/2014/10/23/plain-vanilla/ are two of the most illustrious examples.

Other Evolva products: Working with the Malaysian government and Malaysian academics, Evolva is helping create a local agarwood fermentation industry to produce oudh/agarwood essence, currently sourced from the near-extinct Aquilaria and Gyrinops trees, which have been felled for centuries to feed the global demand for this unique fragrance. Our goal is to produce this same ingredient more sustainably, ethically, and cost effectively. We want to see if this can be a model to help a country that is rich in biodiversity find a more sustainable way to exploit what it has. We would hope long term this can extend to other countries, not just agarwood, and not just to Malaysia.

With biotechnology and fermentation, you can also produce fragrances like musk oil without killing the musk deer or using petrochemicals. And you can produce resveratrol, the ingredient most closely associated with the good-for-you stuff in red wine that can contribute to healthy aging. Resveratrol is currently sourced largely from the root of the Japanese knotweed, an invasive weed that most nations struggle to eradicate.

Feedstock demand: Sure, fermentation uses sugar and that uses land. But it uses a lot less land than growing the vanilla orchid uses, and of course unlike most of the vanillin on the market (which is petrochemical), the carbon in the vanillin coming from sugar does not put net CO2 into the atmosphere. And it’s important to remember that there are multiple sources of sugar already commercially available in the US and EU. The second thing to note is that as fermentation-produced ingredients scale up in the future, and the production process is optimized, alternative non-sugar feedstocks will fill ever larger portions of the demand. This is especially true for non-food ingredients produced from fermentation.

Impact on health and biodiversity: Baker’s yeast has been fortified with additional genes and put into large- and small-scale fermentation production systems to produce myriad products for many years. There is no evidence of harm to human health or biodiversity from this process. This is not surprising and is completely predictable.

First, only a fraction of 1% of our baker’s yeast’s genome is altered, and this modification involves nothing more exotic than adding a few ordinary plant genes to our yeast. The added plant genes are from safe sources and are non-pathogenic. Second, far from being “threatening” or “unpredictable”, our micro-organisms are relatively fragile and shy. They would be outgrown and easily overwhelmed by any wild-type micro-organisms that they might come into contact with, should they somehow make their way from their sealed fermentation facility compound out into the wild. Third, although all of our products are produced in these sealed, “closed-loop” manufacturing facilities, if our micro-organism/baker’s yeast somehow did make their way out into the environment, and found their way into the precise conditions that replicate our fermenters, they would simply grow into vanillin (or the ingredient it was developed to produce).
posted on 2015-06-02 14:07 UTC by Mr. Stephan Herrera, Evolva
This is a reply to 7214 RE: Opening of the discussion on topic 4 [#7230]
Dear colleagues,
I personally share many of the concerns expressed by Jim, as they highlight important perspective that should be taken into consideration.
At the same time I find his example used to illustrate his main point highly unfortunate. Synthetic chemistry produced a lot of problems, too numerous to enumerate. But Synthetic chemistry is one of the greatest success stories in the history of humankind. It is one of the key technologies behind the dramatic increase of human population (certainly a great thing for most of does being born), increase of life expectancy and improved quality of life. Those benefits were shared both by the rich developed countries and by the developing countries. We still learn to live with some of the consequences of Synthetic chemistry but overall it has been a force for good.
I also share the concern about well being of indigenous and local communities, but even this case is not so straightforward. For example substitution of important drug from botanical origin with syntbio product may force the price down and harm certain groups economically, but at the same time it may allow access to medicine to many of the poorest people of the world. In this hypothetical case it is very important to develop programs that will protect the vulnerable groups and will allow more equal sharing of the benefits.
Best Regards,
Nikolay
posted on 2015-06-02 15:08 UTC by Mr. Nikolay Tzvetkov, Bulgaria
This is a reply to 7221 RE: Opening of the discussion on topic 4 [#7232]
Dear all,
Thanks for the opportunity to react again. I am a bit concerned about the reactions in this forum that organisms obtained by synthetic biology are new and we do not know how to assess their risks, for example because we do not have a comparator and/or that we dealing with completely ‘new’ organisms. From my background as a risk assessor of GMOs /LMOs and being closely involved in the risk assessment of new GMO/LMOs at the national and international level, I see the new developments and have hands-on experience in assessing them (as many other people participating in this forum). As mentioned before -I hope I am not repeating myself- all  organism obtained by synthetic biology that exist today and are predicted for the near future fall under the definition of an LMO. Like ‘synthetic’ organisms’,  LMOs can have different applications. Most of these ‘synthetic’ organisms are grown under contained conditions. Experience had learned that LMOs grown under contained conditions so far have not lead to adverse environmental effects, due to an adequate functioning system of containment measures and requirements. In addition, we have an adequate framework to assess LMOs for their environmental release on a case-by-case basis, including the scope of the application and including their products. In my opinion we therefore do not need a new risk assessment system for organisms obtained by synthetic biology and we can make use of the system that has proven to have its value in protecting biodiversity, including human health. However, we have to keep track of the new developments in synthetic biology and we may have to adjust our risk assessment framework depending on these new developments.
Kind regards,
Boet
posted on 2015-06-02 16:31 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 7225 RE: Opening of the discussion on topic 4 [#7237]
Dear all, thank you for valuable contributions so far!
I fully realize that questions put forward last Monday are broad. It is quite difficult to list specific benefits, risks and socioeconomic impacts from synthetic biology organisms and products. However, do not get overwhelmed by the broad scope of the questions. Many of you have already pointed to the fact that it may be extremely difficult to generalize. The importance of a step by step and case-by-case approach has been underlined by many. The suggestion recently made by Hilary Sutcliffe in #7225 on establishing separate threads on social impacts and cumulative effects is interesting, but at this stage with just a few days left, I prefer to maintain the current structure, without any subdivision. That being said, please feel free to deviate and make your own subdivisions if this helps you in promoting your view.
The somewhat limited contribution so far from peasants, indigenous people and local communities may be a correct observation. I can only encourage more people to actively take part in this forum. I very much appreciate the views from Kenyan farmers facilitated by Jim Thomas in #7214.
By contributing to this forum, you are all presenting different angles and view points. This adds up and will feed very nicely into our future discussions and deliberations under the CBD and its protocols.

Best wishes,
Casper Linnestad
posted on 2015-06-03 10:55 UTC by Mr. Casper Linnestad, Norway
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7238]
Dear participants,

First of all let me thank the moderator Casper Linnestad for guiding this discussion.

My name is Didier Breyer. My scientific background is in molecular biology applied to micro-organisms. I work as a senior scientist in the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health (Brussels, Belgium) for more than 20 years. I am mainly involved in the risk evaluation of biosafety dossiers, including contained use applications and environmental releases. I am also appointed as national focal point for the BCH of the Cartagena Protocol.

With regards to questions 1 and 2 (potential risks/benefits to biodiversity and human health) I would like to echo previous contributors (in particular Jim Louter [#7202], Jaco Westra [#7204], Boet Glandorf [#7208], Martin Batic [#7209]) who stated that these questions are very broad and difficult to answer in a generalized way, particularly in the context of a broad philosophical concept such as synthetic biology.

Answering these questions could certainly be facilitated by subdividing ‘synthetic biology’ into different categories or general fields of application, as suggested by Jaco Westra [#7204]. That's what we tried to achieve in a report published by my Unit a few years ago (Pauwels et al. 2012. Synthetic Biology - Latest developments, biosafety considerations and regulatory challenges. Ref: D/2012/2505/46, available on-line at http://www.biosafety.be/SBB/SBB_3.html). Of course alternative sub-categories might be relevant as well.

Referring to this report I would like to provide some general considerations relating to the assessment of potential risks of organisms, components and products arising from SynBio techniques:

- For the time being organisms, components and products arising from SynBio techniques are quasi exclusively used under physical containment, in conditions where potential risks for biodiversity of human health can be easily controlled.
Environmental applications of SynBio are not expected to materialize before several years. However, when such applications will concern micro-organisms it is important to note that risk assessors and regulators have had relatively little experience when considering the potential risks posed by the intentional release in the environment of micro-organisms.

- Current developments in SynBio mainly involve the use of well-characterized organisms and genetic material, for which sufficient knowledge and appropriate comparators are available to assess the potential risks. Therefore potential risks associated with the manipulation of these SynBio entities in the laboratory or their accidental release in the environment can be assessed and managed on the basis of the risk assessment principles and methodology currently applied to GMOs.

- As mentioned by others, we need also to consider that most products (living or non-living) are also regulated based on their intended use (e.g. additives, medicinal products, pesticides, products for bioremediation), which also provide an opportunity to assess their potential risks/benefits.

- As a consequence of the previous considerations and in agreement with Boet Glandorf [#7232] I do not see at this stage the need for a new and dedicated risk assessment framework for organisms, components and products arising from SynBio techniques.

- However, SynBio is a fast evolving field and we may have to adjust existing risk assessment methodologies and criteria in due time depending on these new developments.
For example future applications might involve the insertion of an increased number of parts/traits such as encountered in the building of complex synthetic DNA circuits. The possibility that unintended and unexpected properties emerge from this higher-order of combination of parts cannot be ruled out and therefore make risk assessment more challenging. Even if the source of all of the parts of a SynBio organism are know, and every genetic circuit understood, it could be difficult to assess the interactions between all these parts/circuits and to predict in advance whether the organism would have any unexpected emergent properties. At some point the more a genetically modified organism departs from a know host or donor organism or genetic sequence, the more difficult it will be for risk assessors to predict the characteristics of the modified organism on the basis of the characteristics of the different parts.

Best regards,

Didier Breyer
posted on 2015-06-03 12:12 UTC by Mr. Didier Breyer, Belgium
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7242]
I am Rachel Smolker, codirector of Biofuelwatch, and a resident of the United States. I have a Ph.D. in biology, in particular ecology and evolutionary biology. I would like to comment here first on a matter of process, second on the questions regarding risks and benefits and socioeconomic impacts, which leads to some comments regarding regulation (case by case or otherwise?)

As a matter of process, I feel it is important to identify that industry representatives are participating, very actively, in this forum where the aim is to gain an objective assessment of the risks and potential benefits of synthetic biology.  Those with commercial vested interests have a very clear conflict of interests. They are primarily motivated to ensure their products can be marketed, their patents are profitable, and that assessments of risk and any attendant regulation does not interfere with market potentials. It is to be expected that risks will be downplayed.  I respect their right to participate, but also request that this conflict of interest be identifed and put into context.

As an example, commenter Dannenberg who represents Phytonix reports that his synthetic cyanobateria present "no risk" and much "benefit" to biodiversity and utilize "nothing but CO2". 

A biologist with no vested interests would likely view the use of synthetic cyanobacteria for butanol production quite differently.  I am not familiar with all the details of this particular company, but have researched the general issue of algae fuel production. What I have found is that Cyanboacteria (most are autotrophic), like all living organisms require more than CO2 to grow.  They also need nutrients, generally including phosphorus and nitrogen.  They require large quantities of water - properly controlled for optimal temperature, and exposure to light. Providing those conditions for mass cultivation requires energy. Conditions for optimal industrial cultivation of cyanobacteria can usually only be met in photobioreactors. Numerous lifecycle analyses have shown cultivation of cyanobacteria in photobioreactors to be a net loss as they involve large amounts of materials and energy to maintain optimal conditions and to separate the targeted chemical of interest from the water and cyanobacteria cells.  Photobioreactor cultivation on commercial scales also requires vast areas of land and water. This has implications for biodiversity.

The CO2 needed for mass cultivation of cyanobacteria is not simply sucked out of our overloaded atmosphere, to the benefit of society.  It can only be obtained by hooking up to a polluting industry such as coal burning or cement manufacture or gas refinery, where highly concentrated CO2 streams can be obtained.  They are thus utterly dependent upon the ongoing operation and existence of those polluting industries and practices. Removing CO2 from the smokestack of a polluting coal plant or gas refinery does nothing to halt the destruction of biodiversity caused by, for example, mountaintop removal coal mining, or horizontal fracking for gas.

Those in industry claim they have contained systems and engineered biosafety and thus there is no risk.  Yet,  containment of cyanobacteria is virtually impossible. Like other microbes, they are so very tiny that they very easily become air or waterborne, carried out on shoes, clothing or skin of workers, dispersed through building ventilation, or released en masse due to some natural disaster (flood, earthquake, fire etc).  There are inummerable potential means of escape. Why would we pretend otherwise?

Like many industrial applications of synthetic biology, the products and their use should be considered. For example, Mr Dannenberg's company Phytonix, seeks to use synthetic cyanobacteria to produce butanol. Butanol is a toxic chemical that is used for solvents and other chemicals and potentially for transport fuel.  Ultimately if we are to have a fighting chance to protect biodiversity we will need to reduce the production and use of toxic chemicals, not simply develop alternative means of production.


On risks and potential benefits: 

In submitted comments to the secretariat, I raised concerns on the risks from escape of synthetic microalgae, including potential invasiveness, and possibility of toxic of algal blooms, increasingly common in a warming world. A number of scientists have expressed those concerns in peer reviewed literature on the topic. I also commented regarding the risks to biodiversity associated with processes that require vast quantities of biomass and land.

With respect to human health risks, those cannot be separated from risks to biodiversity as human health is tightly linked to biodiversity. However, many synthetic biology researchers are working to engineer microbes including ecoli, yeast and various other organisms to pump out chemical and fuel molecules.

Can we venture to imagine a scenario wherein an ecoli, engineered to secrete, say, propane, or some industrial chemical escapes containment and manages to contaminate ecoli strains common in the human (or livestock) digestive tract?  That may seem far-fetched, but as we are learning: first of all, the colonization of the human gut is a dynamic and ever - evolving process with far greater consequences on overall health than previously assumed. second: effective containment of microbes is highly unlikely. Given the fundamental and ubiquitous nature of the microbes that are targeted for synthetic biology, we should not hesitate to entertain the full scope of possible risks. 
    
Is there any basis for assuming that "products" of synthetic biology should be assumed harmless as they are not alive? The products must be produced somewhere, no? Hence they must be alive at some stage, somewhere, even if not in the hands of consumers. That distinction makes no sense. 

With respect to regulation: Several argued we should engage in case by case regulation. Without agreed common baselines, it would however be very difficult if not impossible to maintain any consistent standards. The current "DIY" synthetic biology trend is already booming and unregulated. The sheer number of commercial engineered organisms possible through use of these new synthetic biology techniques (tens or even hundreds of thousands of variants possible in a days time and much more rapid-design-build-test cycles) makes case by case evaluation virtually impossible. The sheer amount of time and resources required to evaluate each case separately without any commonly agreed standards will lead to overburdening of agencies to the point of rendering it an impossibility.

As an informative example, even though the US is not a signatory to CBD, it is home to many of the research and development entities using synthetic biology. The US is currently undertaking a revision of biotechnology regulations under APHIS. The process began about ten years ago, was never resolved, and is now starting all over again. Perhaps it will be another ten years before those revised regulations are finalized?  Meanwhile, regulation is increasingly lethargic, careless and unwieldy. The agencies almost universally have granted permits for GMOs, and do not follow up once they have been released.

Now many GMOs are created using new techniques that do not involve "plant pests" (agrobacterium etc) and thus the regulatory agency is throwing up its hands to declare these are not within their purvue to regulate!  That could logically have triggered a halt to permitting, pending development of a new and adequate process for regulation of these new GMOs. But instead it is being used as a gigantic loophole to release various organisms without any oversight at all.  For example, synthetic biology derived "glowing plants" were offered to any and all, without any regulatory evaluation or oversight, in exchange for contributions to a Kickstarter campaign. More recently, the first GMO tree (a loblolly pine with huge potential for cross contamination with natives) was quietly released with no public input or assessment whatsoever simply because the genes do not contain any sequences from known plant pests (plant promoters were used instead of plant viral promoters, and the DNA was inserted using a gene gun instead of an Agrobacterium vector).  Similarly, USDA has permitted release of potatoes engineered using RNAi and genome editing - again, because they did not employ plant pest genes.

In sum- the agency has embraced a supremely narrow and outdated scope for regulatory action and accepted as a default action to release of organisms engineered with new technologies, even as synthetic biology techniques with ever more invasive capabilities are coming to the fore.    

This relaxation of regulation in the face of new technologies is especially concerning because much synthetic biology research involves microbes which are so fundamental to all earth/life processes, (for example, a very recent report details how "above ground biodiversity depends upon below ground soil microbial biodiversity).

Some have mentioned the importance of monitoring after release. While that is essential, it is also useless if there is no clear potential for reversing the harm discovered via monitoring process. That would seem especially likely in the case of microbes. If potential irreversible harm is a possibility, release should be prevented in the first place. 

Perhaps especially key for widely accepted global regulatory agreement at this point would be common and stringent protocols about when and how to make a precautionary judgement - i.e. to determine that assessments are inadequate or impossible and to ensure that the default response is to halt further progress towards the release or use (for products).

We should be seriously asking whether the risks of synthetic biology can in fact be adequately and realistically assessed.  The notion that we can do so relies on embrace of an engineering mindset that believes in predictability and controllability of nature.  Yet we continue to make new and sometimes surprising discoveries about genes, genomes, populations and ecosystems. All are complex, many unknowns remain and "black swans" are clearly existant.

As stated by Federation of German Scientists, synthetic biology represents a "step change" in the engineering of organisms with far greater risks than we have contended with in past. We need a precautionary approach and regulations that mandate holistic assessments, including socioeconomic concerns, not strictly "science based" (as J. Thomas stated well). Failure to evaluate more holistically, including socioeconomic considerations, would be "deliberately choosing ignorance" and ultimately result in failure to protect biodiversity and human rights.
posted on 2015-06-03 14:51 UTC by Ms. Rachel Smolker, Biofuelwatch
This is a reply to 7232 RE: Opening of the discussion on topic 4 [#7243]
Dear colleagues,
First, thanks to the moderator and all participants for highly interesting and stimulating contributions. My name is Alexandra Ribarits from the Austrian Agency for Health and Food Safety (AGES) in Vienna where I work as a senior expert on GMOs. My background is agriculture and genetics, and I am involved in the risk assessment of GMOs, in particular plants. Also, together with my colleagues we finished several projects dealing with various aspects of GMOs, and recently published a report on synthetic biology. As an answer to the question regarding potential benefits and risks of organisms arising from synbio techniques I would like to share the following thoughts.

One of the major potential applications of synbio using plant resources is the reconstruction of plant biosynthetic pathways in heterologous hosts to render production of desired compounds more efficient. A chassis derives from a well-known safe platform cell factory. It is commonly related to organisms which are already routinely used in industrial production. Such organisms are obviously intended for contained use. By the application of appropriate layers of containment potential adverse effects are basically mitigated efficiently. However, although effective provisions and regulatory requirements are in place in the European Union for work with GMOs in contained systems, it should be kept in mind that physical containment is not fail-proof and thus biological containment systems may be applied in addition. The beauty – and potential benefit – of synbio organisms lies in the fact that the organism may be designed with “inbuilt” containment strategies.

Chassis organisms should be able to propagate in a safe and controllable manner, including mechanisms preventing release into the environment and ensuring isolation from other organisms. When looking at the two major approaches of synbio – the bottom-up and the top-down approach – it becomes clear that there are ample possibilities to control cell life and reproduction. One of the major goals of synbio attempts for the moment is to optimize already existing systems, which basically means that they are optimized for efficient production under defined conditions. Organisms carrying a reduced set of genes are likely to have decreased potential for adaption and therefore will not be fit to grow in any given environment. The minimal genome concept allows avoiding potential risks by minimizing the potential of cells to propagate under natural environmental conditions and excluding pathogenicity.

As already highlighted by Dr. Boet Glandorf (#7232) current “synthetic” organisms fall under the definition of an LMO but it is of pivotal importance to monitor developments. Organisms developed by synbio are expected to differ significantly from their presently existing counterparts concerning their properties. I agree that for the time being there is no need to change risk assessment procedures or regulatory provisions – given that synbio organisms fall under the definition of LMOs. The major bottleneck concerning the assessment of benefits and risks of synbio organisms is the restricted potential of predictability (e.g. specific interactions between the organisms and the environment upon intended but even more upon accidental release). Prediction of genotype to phenotype behavior (predictive modeling) is restricted by biological complexity, combinatorial variations and computational limitations. This is even more important when thinking about the lack of suitable comparators and thus a potentially insufficient database for the assessments. We should start as soon as possible to establish data requirements and appropriate safety levels for synbio, aided by adequate risk research. For this, it might also be necessary to allow for the collection of data on an international level.

Best regards,
Alexandra

Link to our synbio report: http://www.bmg.gv.at/cms/home/attachments/2/6/8/CH1052/CMS1422371020012/synthetic_biology_02122014_final.pdf
posted on 2015-06-03 15:15 UTC by Ms. Alexandra Ribarits, Austrian Agency for Health and Food Safety
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7244]
Dear participants,

As this is my first comment to this important forum, let me please first introduce myself.  I am Robert Friedman and I direct a research group at the J. Craig Venter Institute (JCVI) that focuses on the societal and policy implications of modern biology and biotechnology, including synthetic biology.  I am an ecologist by training, worked for many years doing technology assessments for the U.S. Congress, and helped to start an environmental policy think tank, prior to joining JCVI.  I have periodically attended CBD meetings since 2007 to help raise awareness about and understanding of synthetic biology.  I appreciate the opportunity to participate in this on-line forum.

Our moderator, Dr. Linnestad, has asked us to focus on both the potential benefits and risks of components, organisms, and products arising from synthetic biology techniques.  As has been stated well by many other participants, synthetic biology is too broad a topic for meaningful generalizations about the techniques themselves.  I am among those who believe that both benefits and risks can only be assessed case-by-case for each application or product.  Within this discussion topic area, we have focused heavily on one small corner of the types of applications that are being considered—high-value natural products produced by microorganisms under containment conditions, discussed by Jim Thomas (#7214) and Stephan Herrera (#7228).  This discussion is helpful, but perhaps distracting us from the larger picture.

In an earlier discussion topic, Todd Kuiken (#6845 under Topic 3) referred us to the Wilson Center’s recent inventory of active applications to agriculture, biofuels, a wide variety of industrial chemicals, and medicines:  http://www.synbioproject.org/cpi/. I think it is important that we broaden our view and do not lose sight of the types of problems that this young but potentially powerful new technology can help solve.

For example, one of the applications that my organization (JCVI) has helped develop is a method to speed up development of flu vaccines, both to rapidly address an outbreak of pandemic flu and to allow more time to better understand the nature of each year’s seasonal flu.  A previous comment on this technology (#6905) would have preferred that additional time would have been spent to ship a physical sample using a “material transfer agreement”, but this misses the point: accelerating the development of a flu vaccine by a month can save many lives (and the virus sequence was obtained from an open database).

Another of our on-line discussants, Christoph Then, has stated (#7221) that a recently developed technology (CRISPR-Cas9 application to insects), because of difficulties in performing a risk assessment, “should under no circumstances be released”.  One of those applications being pursued is to prevent mosquitos from being able to carry the parasite that causes malaria.  I completely agree that utmost attention must be given to adequate laboratory and field testing prior to release, but the aspiration of those working in this area is to help conquer malaria, which according to the World Health Organization, in 2013, affected 200 million people and killed 600,000, mostly children under 5 years of age.  The particular technology proposed is novel, but the concept is not.  In 2014, WHO and other international organizations such as UNICEF and UNDP, issued step-by-step “Guidance Framework for Testing of Genetically Modified Mosquitoes” for such applications.  http://www.who.int/tdr/publications/year/2014/guide-fmrk-gm-mosquit/en/.

Along with many other of the on-line discussants, I spend much of my time focusing on governance of biotechnology, including synthetic biology.  The potential benefits for addressing infectious diseases, human-induced climate change, and many other challenges to biodiversity and human health are just too great to do otherwise. 

Best regards,
Bob Friedman
posted on 2015-06-03 20:31 UTC by Mr. Robert Friedman, J. Craig Venter Institute
This is a reply to 7244 RE: Opening of the discussion on topic 4 [#7247]
Dear participants,

I am Hideyuki Shirae belonging to Japan Bioindustry Association (JBA).  Thanks moderator of this topic 4 to give me the second opportunity to state my comments.

Looking through the discussion about topic 4, most of participants have problems to answer about 3 questions posed by CBD secretariats due to the quite a broader concept of synthetic biology and uncertainties of three elements “organisms”, “components” and “products”. 
Such problems must be clarified in order to advance this discussion.

Without any procedures of clarifications, it seems to be hard to state any comments about the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity.
If CBD secretariats want to go forward this discussion, I recommend to them that the scientific fields on synthetic biology are categorized, and the specific fields needed new risk assessment and monitoring system shoukd be selected under the mutual agreements.
At such a point, I support Mr. Jaco Westra’s approach (a) about the “operationalization of the questions”[#7218].

At that time, as I mentioned at the beginning of this discussion, some scientific fields based on the modern biotechnology must be removed because the safety and positive and negative effects have been known by 40 year's experiences, and the Cartagena Protocol have already been worked well in the world.  In addition, the technology gives us a lot of benefits as Mr, Genya V. Dana pointed out [#7227]. Also I agreed with Ms. Boet Glandorf ‘s comments [#7211] that “at the moment all organisms obtained by synthetic biology are considered to be GMOs (or LMOs) and we consider the current GMO risk assessment framework therefore applicable also for these 'synthetic' organisms.”.

We also have a variety of regulation systems for IT, chemicals, foods, pharmaceuticals and so on.
We believe such total regulation systems could be cover with those uncertain substances; “components” and “products”.

Regarding the genome editing techniques [#7215], the product-based and case by case evaluation can still be applied now, in comparison with the propertied of its original strain(or species), as many participants supported the procedures.  The risk assessment procedure is almost the same as the method we are using in the Cartagena protocol.  But we might need some adjustments on it for the coming new technologies or future advance of the technology.     I am impressive to Dr. Friedman’s comments against Mr. Christoph Then’s comments.[#7221]

In AHTEG which will be held in this September, we had better focusing on how to make the risk assessment of synthetic biology, and “organisms”, “components” and “products” if those definitions would be fixed before the AHTEG and must be discussed in the light of scientific aspects with evidences, but not emotional matters.  In addition, the argument of the risk assessment will judges profits and risks that the technique brings generally and acts in starting a conclusion in a good balance.

If there is not any mutual agreements about the definitions of “synthetic biology” and other three terms, “organisms”, “components” and “products”, before the AHTEG, we should not advance this consideration further because we should avoid entering the maze without the exit.

Meanwhile, there was a problem of vanillin issue to be marked as “natural”.  As I mentioned in [#7199], the vanillin produced by Evolve, SA is not natural-form.  Eventually Evolva and its partner IFF removed the remark of “natural” from their products in accordance with strict regulations regarding food labellings in EU and North America.  That is over in the issue and we should not discuss further in CBD. 

As participants may not know, Japanese company, which is JBA’s member company, starts supporting the natural vanilla industry in Madagascar since 2013, where is the largest vanilla producing country in the world (production share is more than 60%).
(http://www.takasago.com/en/ir/archive.html?year=2013)

According to the official statement of embassy of Madagascar in Japan, “with more than sixty percent of the world production (1,100 to 1,400 tons per year), Madagascar is the largest exporter of vanilla. Despite this fact, the country is less dependent on this crop, as it represents only 10 to 15 percent of its total exports.” (http://madagascar-embassy.jp/trade_vanille.html)

Notwithstanding the above announcement, the Japanese company decided to invest to Madagascar and established a factory for vanilla essence in 2013, in direct contact with the farmers in the heart of the vanilla cultivation zone in the North Eastern part of Madagascar.  It is doing its best in order to keep the natural resource in Madagascar and to contribute to the local economy and supports many farmers in Madagascar.  They know well who they are, how many numbers of farmers there are and make living by vanilla beans.  They did not announce anything about the environment of the area, and do not state any unreliable number of farmers in the area, either.  The company is living with the farmers in the area. I believe that such activities must be a true contribution and socioeconomic activities for biodiversity. 

I completely agree with Mr. Jim Louter[#7202], Ms. Luciana Ambrozevicius [#7203], and Mr. Boet Glandorf [#7208] in that an assessment of socioeconomic impacts should be separated from the risk assessment.  The discussion outside CBD might be made a solution of problems for people subjecting to some socioeconomic impacts more concretely, such as the above Japanese company case.

It is a pity to hear from Mr Stephan Serrera’s comment [#7228] that there are some organizations which spread wrong information and a malicious rumor in order to disturb some business activities, such as Haagen-Dazs ice cream.  JBA never recommend our member companies to make their investments to the countries whose representatives support to such illegal organization.

Finally, some are misunderstanding, but JBA is a non-profit organization established in 1987. The organization is planning for sound development in bioscience-related industries and is dedicated to solving problems on a global scale through advances in bioscience.  And JBA contact with other similar organizations in the world, and exchange information and opinion regarding all of biotechnology matters frequently.
Please look at our homepage.(http://www.jba.or.jp/pc/en/about/

Best regards,

Hideyuki
posted on 2015-06-04 02:32 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7250]
Dear collegues,
My name is Katsiaryna Sidarenka and I represent the National Co-ordination Biosafety Centre (NCBC) of Belarus.

I want to express sincere thanks for the possibility to participate in this Forum. I found a lot of useful and interesting ideas and information here in order to improve my own understanding of the problem.

If to talk about the discussion occurs, I want to thank Ms. Rachel Smolker (#7242) for pointing out that any case-by-case approach will not be effective without commonly agreed standarts.
Besides, as it was mentioned before, the Cartagena protocol mostly describes transboundary movement of LMO’s so in our opinion it can’t be effectively used as a regulatory document for cases when dealing with all possible varieties of synthetic biology products.

Ms. Boet Glandorf wrote (#7232) that from her point of view “all  organisms obtained by synthetic biology that exist today and are predicted for the near future fall under the definition of an LMO”. Definition of LMO given in Cartagena Protocol on Biosafety is “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”. But nothing is mentioned in the description of “modern biotechnology” about, for example, using of artificial DNA parts or other unnatural cell components never engaged in biological circuits before. However, the scientific research results of that kind are already reported and taking into account the tremendous progress occurring in modern molecular biology nowadays we should consider the opportunity of emerging of such kind of organisms/components/products.

Therefore, we think that some new risk assessment approaches are nedeed, in order to analyse as many variants of consequences of synthetic biology organisms/components/products  usage as possible.

Also, the idea of life-cycle approach, given by Jako Westra (#7218), seems appropriate.

As to the main question of this Topic, the benefits of using synthetic biology organisms/components/products  was already described by many and I’ll join to those of the participants, who underlined the impressive improvement of people’s life (for example, in health) which became possible because of using synthetic biology approach. On the other hand, the interests and welfare of indigenous and local communities has to be also taken into account. It is extremely complicated question, which needs scrutinous analysis before making any decisions and may be it worth freestanding discussion, same as all other possible socio-economic  intricacies  and consequences of synthetic biology usage.

Best regards,
Ms. Katsiaryna Sidarenka.
posted on 2015-06-04 08:57 UTC by Ms. Katsiaryna Sidarenka, Institute of Genetics and Cytology at the National Academy of Sciences of Belarus
This is a reply to 7250 RE: Opening of the discussion on topic 4 [#7253]
Dear Colleagues,

My name is Paul Freemont and I am co-director and co-founder of the Centre for Synthetic Biology and Innovation and UK Innovation and Knowledge Centre for Synthetic Biology at Imperial College London. Firstly I would like to thank the forum for the opportunity of participating in these very important discussions.

I have followed the latest discussions (Topic 4 and 5) with great interest and as a scientist I can only offer my views from the lab bench so to speak.  From the discussions so far I think it is critical that we separate the risk assessment of synthetic biology experiments and research from the socio-economic impacts of potential synthetic biology applications as suggested by many other forum members [#7202 [#7203 [#7208].  This would allow a more focused discussion on the risk and regulatory issues surrounding synthetic biology research and synthetic biology products without confusing the debate with politically motivated opinions which in their own right are extremely valuable and helpful.

Most bench scientists are not trained in social science, economics or politics but are trained to carry out carefully thought out experiments within their local regulatory frameworks. For me this is the UK/EU regulatory framework as oversee by the HSE (for example on synbio see http://www.hse.gov.uk/research/rrhtm/rr944.htm) and currently all of our synthetic biology work fits within these frameworks.  As many forum colleagues have pointed out there are existing and extensive regulatory frameworks already in place around the world for LMO’s and in the last discussions there was agreement among many regulatory experts that such frameworks are appropriate to cover existing synthetic biology developments and LMO’s (see e.g. [#7234]).

From this discussion and previous discussions it is clear that there are some areas of research development (e.g. protocells; xenobiology; germ line editing e.g. gene drives) that will require future deliberations on risk assessment and safety regulations as these applications develop as suggested by others (e.g.  [#7250]).  It is also important to differentiate between applications that are for contained use (e.g. industrial biotechnology applications) where accidental spills/leakages would be a key issue versus deliberate release applications where interactions with the environment and natural biodiversity would be key issues (e.g. horizontal gene transfer, unexpected unbalancing of local eco-systems etc).

Such research programs need to be considered individually on a case-by-case basis in the context the two usages mentioned above. Furthermore, much more research/research funding is required to investigate the safety of such applications (e.g. developing appropriate comparator strains, exploring rates of genetic change and gene transfer etc) and in the context of this forum the effects  (if any) on local and global biodiversity. It is essential that as synthetic biology applications increase an evidence-based regulatory framework is developed based on internationally peer-reviewed research and cross-border agreements.

Finally I wanted to briefly mention that the ‘natural’ versus ‘synthetic’ product debate is perhaps missing the point. Nature has provided us with wonderful chemical substances (smells, tastes, sustenance, medicinal) many from botanical sources. By applying synthetic biology technologies it will be possible to extend the physical and functional diversity of such compounds which could have significant benefits both in developing sustainable production practises but also in discovering new chemical entities that could be used in medicine, agriculture and food. However I can also fully understand the idea of a life cycle approach applied to such new products and processes [#7218].
posted on 2015-06-04 11:05 UTC by Mr. Paul Freemont, Imperial College London
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7256]
My name is Dr. Todd Kuiken. I am an environmental scientist who has been researching the governance and ecological risks and benefits of synthetic biology for the past 6 years as part of the Wilson Center's Science and Technology Innovation Program. Prior to this I was a field scientist researching the biogeochemical cycling of mercury in varying types of ecosystems.
 
While the discussion has been robust I feel that we are not moving forward in evaluating and suggesting how one might develop or utilize some facet of a risk assessment to evaluate the impacts of releasing a “synthetic biology” application. In particular how such an application may impact issues related specifically to the convention on biological diversity.  The Wilson Center has done extensive work in this area and I point you to the following document (http://www.synbioproject.org/publications/creating-a-research-agenda-for-the-ecological-implications-of-synthetic-biology/) which lays out a research agenda around the ecological impacts of synthetic biology. As our inventory suggests (http://www.synbioproject.org/cpi/), the potential range of synthetic biology applications is large and the number of actors is global (http://www.synbioproject.org/inventories/maps-inventory/).

The discussion so far has focused primarily on potential risks and has avoided any significant talk about potential benefits to conservation efforts using these applications.  I point you to the following paper (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3614501/) that discusses such potential efforts as well as a workshop report the Wilson Center produced where we examined the risks and benefits of using synthetic biology to address the Asian Carp invasion of the Great Lakes (attached).

A few comments have raised the issue of the DIY community and I would like to take some time to address this issue.  The DIYbio community is unfortunately too often used as a scapegoat to raise fears around synthetic biology, typically done without any data to back up such claims, and avoids the discussion around potential benefits of what democratizing science could mean to different communities who previously did not have access to such technologies.  The Wilson Center has been working with the DIYbio community for a number of years helping the community to develop ethical guidelines as well as safety and security protocols, which I will argue are above and beyond what many “professional” labs have in place.  I point you to a report we developed a few years ago which addresses some of the myths and realities of the community: http://www.synbioproject.org/publications/6676/.

Let’s take a deeper look at the Glowing Plants project in which Dr. Smolker (#7242) said “…synthetic biology derived "glowing plants" were offered to any and all, without any regulatory evaluation or oversight, in exchange for contributions to a Kickstarter campaign”.  While this statement is in part true it does not tell the entire story. First off the seeds were not offered to “any and all”. They were restricted to residents of the United States, as sending these seeds elsewhere would violate a number of individual countries laws governing LMOs. Now whether these seeds could eventually wind up in other places, again which would violate existing laws, is a legitimate concern and one which this forum should focus on in terms of how LMOs move across borders.

The seeds Glowing Plants are producing for its backers will not be “regulated” by the USDA because they are using a “new” technique, which Dr. Smolker (#7242) rightfully say’s USDA chose to not regulate. However, they are also producing a kit in which individuals can perform the transformations themselves in order to produce the seeds.  These kits utilize agrobacterium which is regulated by the USDA.  So we have a situation where one method is regulated while the other is not. Both methods produce the exact same product. This leads me to suggest we may need to move to a case by case evaluation of synthetic biology applications that evaluates both how the product is made but more importantly what traits in the product are of concern. Restricting any risk assessment to a list of “methods” that this forum defines as synthetic biology will quickly be outdated.

I would finally like to point the forum to some specific models and work produced by the International Institute for Applied Systems Analysis (http://www.iiasa.ac.at/).  Their work, in particular the FELIX model (http://www.felixmodel.com/), could address many of the issues we have been discussing in this forum including the socioeconomic issues which should be included in any risk assessment framework.

I look forward to continuing the discussion.

Todd
posted on 2015-06-04 15:41 UTC by Mr. Todd Kuiken, North Carolina State University
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7258]
Dear forum participants,

Here are my responses to questions 1 and 3 as posed:

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?

I strongly agree with Ricarda Steinbrecher's comment [#7213] that, "There is a serious knowledge gap that needs to be closed for reliable risk assessments, including assessing the assumptions of precision and predictability in living systems." Proceeding with risk assessments of organisms, components and products arising from synthetic biology techniques under the assumption of precision and predictability in living systems seems unscientific, and might even be fairly called "faith-based" at the moment.

There are areas of high risk which I believe to be, if not novel, then significantly increased due to the use of synthetic biology techniques such as gene drives, xenobiology, and engineering invasive species.

While much has been made about advances in synthetic biology solutions for biocontainment (for example http://www.nature.com/articles/doi:10.1038/nature14095) I would hope that engineered "kill switches" not be considered an adequate response to biosafety concerns arising from synbio applications like gene drives. I agree with the comments of others who've noted that no containment system is 100% effective.

I do not believe that there is an existing process for full technical or socioeconomic risk assessment and therefore the precautionary principle is of critical importance. I do not believe that it is sufficient to say this can be dealt with by government agencies using existing risk assessments on a case-by-case basis. Given the current speed of innovation by the time an assessment has taken place it may conceivably be too late.

I therefore agree with Rachel Smolker’s [#7242] comment: “Perhaps especially key for widely accepted global regulatory agreement at this point would be common and stringent protocols about when and how to make a precautionary judgement - i.e. to determine that assessments are inadequate or impossible and to ensure that the default response is to halt further progress towards the release or use (for products).”

I agree with others who've pointed out that a multidisciplinary approach to risk assessment by engaging social scientists, in particular with respect to socioeconomic impacts, will be highly valuable.

3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

While requiring more effort than if they were simply ignored, I believe that it is important to consider socioeconomic risks and benefits and am glad to see that this question is being raised. Though some might consider these impacts "indirect", socioeconomic impacts on the preservation of biological resources are to me clearly significant and relevant to the CBD.

I am concerned that negative impacts will be disproportionately borne by small scale farmers and by Indigenous Peoples, who may already be experiencing disruptive impacts on livelihoods and land use.

It is of utmost importance to Canadian Friends Service Committee that the rights of Indigenous Peoples be justly and duly considered as required by international law including the United Nations Declaration on the Rights of Indigenous Peoples (in particular Articles 3, 4, 5 and 11 http://www.un.org/esa/socdev/unpfii/documents/DRIPS_en.pdf).

I would remind forum participants that the CBD, States and synthetic biologists should be thinking in terms of the standard outlined in Article 31, "Indigenous peoples have the right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as the manifestations of their sciences, technologies and cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures [...] They also have the right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional knowledge, and traditional cultural expressions." This Article is by no means specific to synthetic biology but does bear raising up in this forum, in particular since it has been noted that there do not appear to be any Indigenous Peoples represented here.

I do not have enough clarity right now to comment/speculate on the positive socioeconomic impacts, and would just reiterate the query – how can the CBD best promote the fair sharing of positive economic impacts, in particular between developed and developing countries?

All the best,
Matthew Legge
Canadian Friends Service Committee (Quakers)
posted on 2015-06-04 17:54 UTC by Mr. Matthew Legge, Canadian Friends Service Committee (Quakers)
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7260]
My name is Mariska Wouters and I am a senior policy adviser in new organisms under the Hazardous Substances and New Organisms (HSNO) Act for the Ministry for the Environment, New Zealand. Currently my role focuses on a review of the HSNO (Organisms Not Genetically Modified) Regulations 1998 in response to developments in genetic technology. My background is in social science research and participatory processes, particularly in conservation.

Many thanks to the moderator and participants for this interesting discussion.

I will provide general observations and specific comments in response to all three questions.

New Zealand underlines that robust and effective risk assessment and risk management procedures are essential to maximise the benefits and reduce risks to the conservation and sustainable use of biodiversity, including benefits and risks arising from the components, organisms and products of synthetic biology.

New Zealand agrees that discussions on synthetic biology should be in the context of potential impacts on the conservation and sustainable use of biological diversity. Specific provisions of the CBD and of the Cartagena Protocol that are relevant in this regard include:

-CBD Article 14, which recognises that each Contracting Party shall, as far as possible and as appropriate… “introduce appropriate procedures requiring environmental impact assessment of its proposed projects that are likely to have significant adverse effects on biological diversity with a view to avoiding or minimising such effects”.
- Cartagena Protocol Article 1, which refers to LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
-Cartagena Protocol Article 15, which recognises and provides for risk assessment of the effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

We support the submitters [Dr. Genya Dana (# 7227), Dr. Jim  Louter (# 7233), Dr. Luciana Anbrozevicius (#7234), Dr. Didier Breyer (# 7241), Ms Maria Roca (#7259)] who advocate for a case-by-case assessment of risks and benefits. This reflects New Zealand’s risk assessment approach, which may be of interest. When making decisions, we consider scientific/technical risks, as well as other factors such as socio-economic factors – all on a case-by-case basis. This provides flexibility to consider new information within a context-specific national framework.

New Zealand undertakes risk assessment through the Hazardous Substances and New Organisms Act (HSNO Act), which would likely regulate organisms produced through synthetic biology. This Act: regulates both new organisms (including GMOs/LMOs) and hazardous substances (with defined intrinsic properties); considers both environmental and human effects; and decides on applications for import, development, containment or full release into the environment.

The purpose of the HSNO Act is to protect the environment and the health and safety of people and communities by preventing or managing the adverse effects of hazardous substances and new organisms. ‘Environment’ includes ecosystems and their constituent parts including people and communities, all natural and physical resources, amenity values, and the related social, economic, aesthetic and cultural conditions. ‘Effects’ include potential or probably effects; positive or adverse effects; temporary or permanent effects; past, present or future effects; acute or chronic effects; and cumulative effect which arises over time or in combination with other effects.

To achieve the purpose there are several principles: the safeguarding of the life-supporting capacity of air, water, soil, and ecosystems; and  the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural well-being and for the reasonably foreseeable needs of future generations. A further principle of the Act is the precautionary approach.

Other matters relevant to achieve the purpose of the Act include: the sustainability of all native and valued introduced flora and fauna; the intrinsic value of ecosystems; public health; the relationship of Maori and their culture and traditions; the economic and related benefits and costs of using a particular hazardous substance or new organism; and New Zealand’s international obligations.

Finally, we welcome the contributions regarding living and non-living organisms and references to chemical frameworks. New Zealand is interested in understanding further how the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and the Strategic Approach to Integrated Chemicals Management (SAICM) may apply to non-living components and products derived from synthetic biology techniques.

Thank you again for the opportunity to provide input.

Kind regards,
Mariska Wouters
New Zealand Ministry for the Environment
posted on 2015-06-05 05:24 UTC by Ms. Mariska Wouters, New Zealand
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7263]
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 and I am charged with the monitoring of Synthetic Biology on behalf of the German Central Committee for Biological Safety (ZKBS).

I would like to agree to Nikolay Tzvetkov,  Luciana Ambrozevicius  and others that there may be potential risks and benefits from synthetic biology components, organisms and products to human health, conservation and sustainable use of biodiversity. These include risks like an invasive potential, different land use and change in cultural practices or benefits like the continuous production of substances from scarce natural sources, bioremediation, new diagnostics and therapies.

However, it is difficult to address the risks and benefits more specifically, if we have no clear definition of synthetic biology. To my mind, the much discussed vanillin case is not clearly a product of synthetic biology, but more like of traditional genetic engineering. Additionally, most synthetic biology applications will be in contained use. It is therefore unlikely that those will have any negative impacts on human health, conservation and sustainable use of biodiversity as has been seen with traditional GMOs over the last decades.
I also agree with Jaco Westra that a subdivision in different fields could be useful.
posted on 2015-06-05 09:47 UTC by Ms. Swantje Strassheim, Germany
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7264]
Dear all, as a moderator of topic 4 of our online-forum on synthetic biology (focusing on potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols), please allow me to remind you that this part of our discussion will close on Monday, 8 June at 1:00am GMT. Hence, for those of you still thinking of submitting a view point or comment, please do so by the end of this weekend. Your joint efforts and contribution is very much appreciated. Collectively, the views presented over the last couple of days gives us an excellent starting point for further deliberations under the CBD and its Protocols. At the same time, there is no simple route ahead of us. Synthetic biology is such a complex issue, both socially, scientifically and also from a political standpoint. Indeed, we have interesting days ahead of us! Thanks again all of you for being so active, and thanks to the Secretariat for honoring me with the task of moderating this part of our discussion.

Casper Linnestad
posted on 2015-06-05 10:17 UTC by Mr. Casper Linnestad, Norway
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7265]
Good day to everyone, to our moderator and participants in the forum,

I am Rosette Ferrer from the Southeast Asia Regional Initiatives for Community Empowerment (SEARICE), an NGO that promotes farmers' rights and the conservation, development and sustainable use of plant genetic resources for food and agriculture. I have engaged in CBD meetings and discussions before on the topic of synthetic biology, bringing the voices of smallholder farmers.

The task of properly regulating the use of synthetic biology techniques starts with identifying its potential impacts, both direct and indirect, on biodiversity. Because the field is evolving fast, new techniques arise and, with it, new potential risks and benefits. Identifying potential benefits and risks will be difficult, but picking out those that are common among all the techniques that come under the umbrella of synthetic biology can be a good move forward, without sacrificing addressing significant risks from specific techniques.

I agree with Rachel Smolker [7242] that organisms, components and products from synthetic biology techniques have to be evaluated holistically. I understand the laser-like focus on “science-based” risk assessments by the many learned scientists in this forum. But, as pointed out by Nikolay Tzvetkov [7207], Sarah Agapito-Tenfen [7212] and many members of civil society, social and economic sciences are not any less scientific, and would doubtlessly have rigorous methodologies that can contribute to our understanding and prediction of possible indirect impacts on social and economic systems and structures that will, in turn, impact on the conservation and sustainable use of biodiversity. This idea of social and economic structures having an impact on conservation and sustainable use of biodiversity is not new. The CBD, its protocols, and various COP decisions have repeatedly recognized the vital role of indigenous and local communities. The idea is summed up in the term “bioculture.” The idea can also be seen in the recognition of the many human-induced drivers of biodiversity loss.

The human element, or human intervention, is an integral part of the ecosystem in agricultural biodiversity, which will be greatly impacted by synthetic biology. The welfare of farmers, and their continued share in the bounty of biodiversity, must therefore be considered. Applications of synthetic biology are and will be seen  in the modification of crops, and in the synthetic substitutes for natural products. For one, the Swiss company Evolva is using synthetic biology to develop saffron, vanillin, and stevia.   A more immediate threat to Filipino farmers comes in the form of synthetic coconut oil. The displacement and “economic shift” in production that this will result in will be massive and will have a great impact on the attainment of sustainable development goals, especially for developing countries whose industries rely on production of natural or raw goods. Synthetic biology is a disruptive technology. The question that should be asked is not just “what” the potential benefits and risks are, but also “who” – which segments of society will be benefitting and which will be bearing the risks. In other words, “how” are these benefits and risks going to be allocated within society?

First, the objective of ensuring access and benefit-sharing, and the concurrent respect for traditional knowledge, are mechanisms by which the Convention and its Protocols addresses the human-nature nexus and ensures that human activities (knowledge, innovations and practices of indigenous and local communities) that have a positive impact on biodiversity are able to share in its bounty and not taken advantage of. As the techniques of synthetic biology move farther and farther away from its natural components, requiring no/little actual physical access of genetic material, risks of biopiracy and misappropriation increase. Synthetic biology techniques need only a database of genetic information. Questions as to the treatment of traditional knowledge inevitably arise. A petition has been filed urging the UN to create a legal framework requiring governments to make data from the genetic sequencing of plants freely available. The proponents say the move would speed up plant breeding and increase food production for a growing human population, one of the UN’s proposed Sustainable Development Goals (SDGs).  However, safeguards to this free access would have to be put in place for access and benefit sharing laws to be observed. Many representatives of industry in this forum tout the potential benefits of the application of synthetic biology. Yet, they fail to address concerns of benefit-sharing. Obviously, those with a financial stake in the technology will prosper if the venture is successful commercially. Maybe their customers or clients will reap benefits. But these benefits ride on the back of indigenous and local communities who have conserved and sustainably used the slice of biodiversity that made the technological application possible. In this regard, I echo the concern of Matthew Legge [7260] regarding the impact on indigenous and local communities and benefit-sharing.

Second, socio-economic considerations arising from the impact of organisms, components and products of synthetic biology on conservation and sustainable use, especially with regard to the value of biological diversity to indigenous and local communities should be part of the regulatory process. Potential risks and benefits arise from two actions: not just environmental release, but also through commercial use. The synthetic versions of natural products will have an effect on the market for these products, impacting livelihoods of farmers, whose practices safeguard the genetic diversity of crops. Part of the Preamble of the CBD states that contracting parties note that “the fundamental requirement for the conservation of biological diversity is the in-situ conservation of ecosystems and natural habitats and the maintenance and recovery of viable populations of species in their natural surroundings.” Reemphasizing the need for holistic evaluation, it is quite puzzling why, for example in the case of the Philippines as mentioned by Saturnina Halos [7205], socio-economic considerations are taken into account only for government-funded projects and not for the private sector. It may be difficult, but a long-term and wider evaluation of such disruptive technologies is necessary to mitigate or prepare for risks that will impact on biodiversity and development. However, the difficulty is in establishing conceptual clarity and methodology. This can be seen in the protracted discussions on socio-economic considerations under the Cartagena Protocol, where guidance for socio-economic considerations have fallen behind other technical considerations. We must learn from this experience and start early. Socio-economic considerations should be stronger in the regulation of synthetic biology. Another relevant issue that was raised by Hilary Sutcliffe [7225] is the question of whose job is it to prioritize, or to balance interests? At what level of government should that decision be made? Also, at what stage – research, development, or application etc. – should the decision be made?

Lastly, the COP, through its decisions, have recognized the inexorable link between human health and agricultural biodiversity. Synthetic versions of natural products will likely be genetically uniform, and, without in situ conservation, will likely further lead to genetic erosion. The 2014 report on the right to food, and the 2009 report on seeds by Olivier de Schutter, former UN Special Rapporteur on the Right to Food, highlight the importance of seed diversity to diet diversity. The homogenization of diets globally has been a major factor in health problems and pressures on the environment.

I hope this contribution helps in moving the process forward.

Regards,
Rosette
posted on 2015-06-05 10:26 UTC by Ms. Rosette S. Ferrer, Southeast Asia Regional Initiatives for Community Empowerment (SEARICE)
This is a reply to 7265 RE: Opening of the discussion on topic 4 [#7267]
Dear Fellow Participants of the Online Forum on Synthetic Biology,

Hello. My name is Mark Petry.  I work at the United States Department of Agriculture, Foreign Agriculture Service, New Technologies and Production Methods Division.  I work on issues related to trade in products of biotechnology and international agreements related to agricultural technology/innovation, safety, and trade.

I would like to express my thanks for the Secretariat and moderators for holding this informative and lively discussion.

My comment is about the scope under which to take into account socio-economic considerations.

Under the Cartagena Protocol, Parties “may also take into account, consistent with their international obligations, socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity…”.  That reference from Article 26.1 of the CPB is an important caveat that specifies that, under the Protocol, socio-economic analyses are done in certain situations and are dependent on the finding that the LMO in question has impacted biodiversity.

Few peer-reviewed, independent studies exist on the potential socio-economic impacts arising from the impact of biological engineering on biological diversity. Therefore, we need to be careful about statements on socioeconomic impacts of biological engineering, as the ones being discussed on the Forum thus far are much more broadly described than is defined by the Protocol. We should also keep this in mind as we view statements also not supported by empirical evidence.

Thanks

Mark Petry
posted on 2015-06-05 11:54 UTC by Mr. Mark Petry, United States Department of Agriculture
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7269]
Dear All, I’m Valeria Giovannelli and I work for the Italian Institute for the Environmental Protection and Research. I wish to thank the moderator to have recalled the concepts and maintained the division made in the previous discussion on Synbio, in my opinion that will give the opportunity to better collect all the comments posted in this forum.
As we are in the last moments of the forum, I will just recall some of the comments on which I agree without raising other minor points that I‘m sure will be point out in further discussions. In my opinion the answer to this topic can be given only after a (environmental, socioeconomic) risk/benefit assessment conducted on a case by case basis.
Furthermore I agree with comment #7205, made by Mrs Saturnina Halos, when she underlines that “the issues raised by organisms, components and products will differ.” In case of organisms produced by synbio techniques, they would fall under the Cartagena Protocol provisions and the relative risk assessment framework can be applied, including case by case approach and the precautionary approach. I agree with the idea that, for the current organisms and for those that will be produced in the immediate future, the experience gained through LMOs use and related risk assessment procedures (including benefits assessment) can be used in the assessment of those organisms, even if for some of them adjustments may be required (for example, in case of the absence of a natural counterpart - Nikolay Tzvetkov #7201). As far further and future applications of synthetic biology, research activities shall be forecast and focused on potential risks/benefits analysis. For these reasons I agree with Ms. Boet Glandor (#7232) that “we have to keep track of the new developments in synthetic biology and we may have to adjust our risk assessment framework depending on these new developments”.
About products and components: potential risk and benefits should be assessed on a case by case basis, and I believe that these issues should be addressed within different risk/benefits assessment framework, that need to be yet explored.
About potential socioeconomic impacts, I agree that that they should be assessed in separate frameworks that take into account the results of related environmental risk/benefit assessment.
Best regards
Valeria
posted on 2015-06-05 13:14 UTC by Ms. Valeria Giovannelli, Italy
This is a reply to 7269 RE: Opening of the discussion on topic 4 [#7270]
I am Odd-Gunnar Wikmark from GenOk - Centre for Biosafety located in Tromso, Norway. We are a national competence center for biosafety and work for the safe use of biotechnologies.

I would like to thank the moderator Casper Lindestad for taking the task of moderating the topic.

I agree with many of the participants in this forum that it is very difficult to give generic statements on potential risks and benefits of organisms, components or products arising from synthetic biology techniques. I agree that the case-by-case approach are imperative to use in risk assessment of synt bio but in order to uncover relevant risks from new products or new process lines, it is important to also consider the process in risk assessments.

Some participants (i.e. Christoph Then,#7221) has raised very important question on how to handle products that are very difficult to assess and this could also be extended to concerns on products that can not be monitored or detected (i.e. products from genome editing techniques). I would also like to point RNAi-based insect resistant plants as examples on how difficult assessment may be. Today we do not fully understand the uptake mechanism of ss-RNA. Target organisms are of course tested in the laboratory, but because we do not understand how the uptake is regulated in all species, it is very difficult/impossible today to predict how ss-RNA producing plants affects non target organisms. How do we handle this in RA? It is important that the attention of this forum is given to how to handle such products.   

Regarding social impacts, I would like to point to the Norwegian gene technology act as an example of that it can be done. The purpose of the act states “The purpose of this Act is to ensure that the production and use of genetically modified organisms and the production of cloned animals take place in an ethically justifiable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on health and the environment.”


best wishes,

Odd-Gunnar Wikmark
posted on 2015-06-05 13:25 UTC by Mr. Odd-Gunnar Wikmark, GenØk - Centre for Biosafety
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7271]
Dear all, I am Matteo Lener from the Italian Institute of Environmental Protection and Research.
Reading the comments on the forum I agree with many of them regarding the need to apply a case by case approach on assessing risks, benefits and socio-economic impacts. I’m wondering if how to assess them it is matter of this specific topic or others. Indeed, in topic 3, we have just discussed on the Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques. According to my experience, in EU, it seems reasonable to apply current risk assessment procedures and monitoring regimes performed for LMOs, even if in future could be necessary to improve them according the development of techniques and knowledge. Moreover, the risk assessment procedures of the Cartagena Protocol can represent an useful instruments to start to evaluate the impacts of living organisms derived from synthetic biology.
However, regarding the assessment of cost-benefits and socio-economic impacts, considering that these topics are yet in discussion for LMOs, we need to develop and to adopt specific frameworks, i.e the idea of life-cycle approach, to assess cost-benefits seems appropriate.
posted on 2015-06-05 13:26 UTC by Mr. Matteo Lener, Italy
This is a reply to 7264 RE: Opening of the discussion on topic 4 [#7272]
Dear Dr Casper Linnestad,

My name is Panchapagesa Murali As the President of Association of Biotechnology Led Enterprise (ABLE) the Biotech Industry association body of India.

I am pleased to contribute to this dialogue and thank the moderator for his indulgence. I want to focus my comments on the assertion that something is missing from this dialogue, and therefore the full and fair range of opinions are not being captured. Ironically, this assertion is being put forth by critics of synthetic biology, the same critics who have completely dominated discussions on synthetic biology at the CBD for years.

As it happens, there is not a dearth of opinion on this online forum. The content certainly proves that point. There is in fact a wide array of viewpoints to consider. It’s just that the critics of synthetic biology would simply prefer that we assign greater weight and credibility to their viewpoints, and less to the scientists and companies that work with biotechnology, some of them for going on 30 years now.

A line from George Orwell’s Animal Farm comes to mind here: “All animals are created equal, but some are more equal than others.”

Science is not the enemy here.

Take insulin and artemisinin, both of which are brewed in fermentation quickly, cost effectively, and under national oversight and regulation. Together, these medicines have saved many millions of lives. In the case of artemisinin, synthetic biology helped (among other things) eliminate both technical and supply chain problems that were creating an unmet medical need. And yet to hear critics tell it, synthetic biology was not the hero here, but rather a villain that is to blame for the emergence of artemisinin resistance. Malaria is fiendishly adaptive. Just ask the UN’s own malaria experts: resistance is a fact of life in the treatment of ALL infectious diseases.

It seems to me that if there is anything missing, it is not a diversity of viewpoints. Rather, what is missing is a willingness on the part of some to acknowledge, for example, that bioethicists and independent scholars from around the globe have measured the pro and con and concluded that the pro vastly outweighs the potential risks associated with synthetic biology. Nobody from industry or academic institutions is arguing that there are no cons. Every technology has them and synthetic biology is no different in this regard. Like all technological advances, the synthetic biology branch of biotechnology needs to be regulated, and these regulations need to be subjected to both periodic and circumstantial review, and diligent enforcement. Public education, public engagement, and public input need to be an institutional commitment if we are to have truly responsible innovation. There is no disagreement about this.

The fact is that just as some applications of synthetic biology are more risky than others, some of these applications of synthetic biology also have more benefits than others.

Unfortunately, the small cadre of critics of synthetic biology who have dominated the agenda and forced the diversion of scarce CBD resources in the process continue to paint synthetic biology in broad brush strokes, pushing the idea that the benefits are imaginary and self-serving, while the risks are unknown and unpredictable.
The end result is that the benefits of synthetic biology continue to be dismissed or discounted by some CBD delegates, despite the fact that bioethicists, environmental impact experts, and technology assessment advisors to governments all by and large agree that the potential to do good outweighs the potential risks that come with the pursuit.

Finally, I would like to say that I agree with a post from earlier this week that there is no evidence to support the PR campaign hatched by the group that says that, “synthetic biology products currently in the pipeline will have serious negative social and economic impacts for thousands of peasant and indigenous communities, particularly those based in Asia, Africa and Latin America”. As has been pointed out on this forum, where is the evidence to back up this hyperbolic talking point? If there is no evidence, then what is the societal benefit from pushing this and other pieces of misinformation about synthetic biology upon the media and farmers in the global south? I implore the more intellectually honest NGOs start to speak out more loudly against this sort of fear-mongering.
posted on 2015-06-05 14:43 UTC by Mr. Murali Panchapagesa Muthuswamy, Association of Biotechnology Led Enterprise (ABLE)
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7273]
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). Thanks for the opportunity to contribute to the discussion.

Synthetic biology, as explained by practitioners and commentators, is potentially transformational and will pervade multiple sectors and industries, so much so that it is very difficult to list all potential applications, each of which may present different types and net balance of benefits and risks. As Jacko Westra and others have indicated there is merit in segregating the types of applications (eg contained use, deliberate release, biomanufacturing) and adopting a sectoral approach to this assessment. This permits resources to be directed to where they are most required and avoids a stifling ‘one-size fits all’ approach, which may lead to superficial assessment and failure to focus on relevant matters. Consequently, the case by case, step wise approach to risk assessment proposed by Jim Louter and others should not be seen as narrow but rather a targeted and proportionate approach.  

In practice progress in synthetic biology applications is still incremental and not far removed from existing genetic engineering techniques. In order for the benefits and transformational potential to be realised, the regulatory framework needs to not only provide the processes and mechanisms for identifying, assessing and managing the risks that may arise from emerging technologies but do so in a manner that faciliates the realisation of the potential benefits in a safe manner (eg in areas of health, medicine, food and energy)1. As Boet Glandorf and others have mentioned the current regulatory processes are suitable (perhaps with future adaptation and guidance on their interpretation) to provide the processes and mechanisms for effectively assessing the risks. In the EU, the same regulatory framework applies whether the practitioner is a University, company, iGEM team or DIY Biologist. Some refinement may be necessary to this system to adequately consider the potential benefits.

In the UK, the Synthetic Biology Leadership Council (SBLC)2 was established as a strategic co-ordinating body for the UK’s interests in the rapidly developing field of synthetic biology. SBLC works with industry, relevant academic disciplines (including engineering, biology, chemistry, physics, mathematics, the social sciences and ICT), regulators, NGOs and across Government. In addition, the SBLC has formed a Governance Subgroup, which promotes a responsible, transparent and sectoral approach to the governance of synthetic biology. This oversight complements the regulatory framework and is a model that may be useful for other parties to consider, as a means of encouraging an open, adaptive and consultative approach to governance of synthetic biology so that the full benefits can be realised and negative impacts avoided or minimised.

In terms of socioeconomic impacts from synthetic biology, as Jim Louter, Boet Glandorf and others have indicated, this should be a separate consideration that may be necessary depending on the context of use or application of synthetic biology.  An AHTEG under the Cartagena Protocol on Biosafety is considering how socio-economic factors might be taken into account in decision-making on a voluntary basis. The outcomes of this work may also be useful for the work under the CBD on synthetic biology.

In the EU, the European Socio-Economics Bureau has developed a guidance document on how to take socio-economics into consideration including a list of indicators and suggested methodologies, which will be published in the near future. This guidance document could be a useful resource for work in this area.

1 Rhodes (2014), ‘Relevance of genetic resources governance of synthetic biology’, Ethics in Biology, Engineering & Medicine – An International Journal, 5(2): 161-183
2 A synthetic biology road map for the UK (https://connect.innovateuk.org/documents/2826135/3815409/Synthetic+Biology+Roadmap+-+Report.pdf/fa8a1e8e-cbf4-4464-87ce-b3b033f04eaa)
posted on 2015-06-05 15:17 UTC by Mr. Michael Paton, United Kingdom of Great Britain and Northern Ireland
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7274]
Dear members.

I am Daisuke Kiga, an associate professor in Tokyo Institute Technology.  Please allow me introduce myself.  I got my Ph.D. in a department of Biochemistry and Biochemist.  Although my background is in “wet” experiments, I am now affiliated with Department of computational intelligence and systems science to combine wet and dry approach in synthetic biology.  For 10 years in Tokyo tech, I have also been an instructor of iGEM , an undergrad student competition in synthetic biology field.

I deeply thank our moderator and posts in this forum.  They really expand my thought.  iGEM students, potential stake folders in next generations in this field, would also learn much, if they could access this flow of discussions.

I firstly appreciate post #7218 from Dr. Jaco Westra since it mentioned “the risk assessment of chemicals (synbio products) well tested and developed frameworks exist.”  I think that we should respect preexisting frameworks which has brushed up through discussions to consider risk and benefit in each field.  Not only innovation in biological production of chemicals, but innovation in traditional synthetic chemistry contributes to make our life style safe. Such benefits in biological engineering was mentioned in #7227 (Dr. Genya V. Dana) and #7244 (Dr. Robert Friedman) and so on.  This is why preexisting frameworks allows small scale trials.  In this line, I would not support moratorium in SynBio.

Thus I also support case-by-case assessment. Indeed case-by-case assessment may require agreed common baselines (#7242 Dr. Rachel Smolker), but preexisting frameworks can be used as such baselines.  Properties of chemicals produce by Symbio do not differ from those by synthetic chemistry. Most of LMOs produced by SynBio procedure do not differ from those by “traditional” recombinant DNA technology.  These can be separated from exceptional cases which may require new common baselines.
posted on 2015-06-05 16:14 UTC by Prof. Daisuke Kiga, Waseda University
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7276]
Dear participants,

My name is Ana Atanassova, my background is in molecular biology and GMO risk assessment and I work for Bayer CropScience as global regulatory manager.  I have been following the discussion with a lot of interest and would like to add my contribution to the forum on Topic 4 also representing Crop Life International.

In addressing the questions under Topic 4 about the potential risks and benefits of organisms, components and products developed with synthetic biology approaches, I share the position of many on this forum that  the question of “what are the risks and benefits” can be answered only very broadly.  The potential risks of the product (LMO) should be addressed on a case-by-case basis, consistent with the principles of risk assessment applicable to LMOs and  highlighted in many of the comments posted so far in the forum and also addressed by many under Topic 5.  Some participants to this forum indicated that risk assessment can be tailored to the type of application, e.g. contained use, limited environmental release, or commercial use, and this is in accord with the current practices in risk assessment and risk management for LMOs and is equally applicable to organisms developed with the use of synthetic biology approaches. I also think that the point made about absence of suitable comparators [# 7201, 7212] should be carefully considered for validity as comparative assessment is just one way to establish the safety of a new product (LMO) and the lack of comparator per se is not a challenge in the risk assessment process.

I appreciated the explanation from the representative of Evolva [#7228] and the comment from Hideyuki Shirae [#7247] about the difference between vanilla (a complex natural product) and vanillin (a specific chemical molecule) and believe that the post by Robert Friedman, J. Craig Venter Institute [#7244] is very helpful for our discussion by pointing out to the potential of synthetic biology applications for human health.
Finally, I would like to acknowledge the good practice of some in the forum to provide links to information referenced in their posts and I would welcome others to also provide sources when data is presented.

Kind regards,
Ana
posted on 2015-06-05 16:57 UTC by Ms. Ana Atanassova, Bayer CropScience
This is a reply to 7223 RE: Opening of the discussion on topic 4 [#7278]
POSTED ON BEHALF OF RAMASWAMY SUBRAMANIAN

----

Dear All,

My name is Ramaswamy and I work as the Dean for  the Institute for Stem Cell Biology and Regenerative Medicine in Bangalore, India.  Most of the research work in my career so far has been on protein engineering and biocatalysts.   I appreciate the moderators and the participants views and stand enlightened in many ways. 

Is there a reason why the entire discussion so far has been confined to prokaryotes.  The first one came from Ms. Soka Jannet Copa on flies.  I want to switch to humans.  In medicine, the idea of engineering cells and re-introducing them into humans (gene - therapy and stem cell therapy) raises many of the same issues.  Analogous to prokaryotes and flies are people with engineered genes (a treatment that works well in certain hematopoietic conditions for example) should be considered as dangerous to society.  There is no clear evidence that they are not as they have not been around for several generations. 

I bring this up to say that our fear of the unknown often takes over in these decisions.  One can develop a set of clear trails (based on best scientific practises) to verify.  Often, any new technology has risks and benefits.  If the benefits out weigh the risks, then the focus should be on minimising the risks rather than abandoning the technology.   It is well established that “chemotherapy” is toxic.  Yet, very few cancer patients deny the use of it in spite of knowing its toxicity. 

As I read the thread there seems to be a need to clearly make a a list of measurable “risks” and measurable “benefits”.  Each be given a score (as all items might not have the same weight).  Follow this by providing a clear method to say what are acceptable scores for its use.  We can probably learn a lot from the statistical conditions and criteria used in clinical trials.  I am the first to agree they are not the best - but, it is the best we have and we can also strive to improve it.

Best regards,

Rams.
posted on 2015-06-05 19:23 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7278 RE: Opening of the discussion on topic 4 [#7280]
Thank you,  Casper Linnestad, for moderating this part of our discussion.

I am Elpidio Peria, once again, from the Philippines,  of the Biodiversity Management Bureau, of the Department of Environment and Natural Resources.

1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?

The assessment of potential benefits and risks to the conservation and sustainable use of biodiversity may take off from the methodologies used in the  assessment of the impacts of genetic engineering technologies under the Cartagena Protocol, only to the extent that such synthetic biology techniques are similar to the methodologies based on genetic engineering technologies, but where they differ significantly  like what has been pointed out by Ricarda Steinbrecher (#7213), such as the following -   genome editing, epigenetic alterations (including external application of dsRNA), gene drive systems, metabolic pathway engineering – including photosynthesis engineering, cell free system applications, ribosome engineering, cell-membrane engineering, production of newly designed nucleotides (xeno-nucleotides) and amino acids - then there should be a separate methodology or process for the assessment of these benefits and risks of these synbio techniques, which should be qualitatively different from current risk assessment methodologies. This is similar to what was pointed out by the CBD Technical Report No. 82 in p. 37,  that the  adequacy of environmental risk assessments and regulatory structures designed for GMOs/LMOs will depend on the perceived novelty of synthetic biology, and  the same Report also said in p. 38 that if and when future commercial applications of synthetic biology evolve to use techniques that do not rely on the in vitro manipulation of nucleic acids to cause inheritable changes in the organism, then current methodologies for environmental risk assessment may no longer be suitable.

In earlier interventions, blanket statements from Hideyuki Shirae (#7199) that “there are no any bad effects on the biodiversity in nature” and “both ‘Products’ and ‘Components’ also do not give any effects on biodiversity”,  and “it is proved that there are not effects on the conservation and sustainable use of biodiversity , and related human health and socioeconomic impacts”   countered by Silvia Ribeiro’s (#7206) assertion that “it is highly arbitrary to claim that synthetic biology products will not have impacts on health or biodiversity, because they are not “alive”. There are no studies, experiments or proof that can demonstrate this”  both appear to cancel each other as both of them did not cite any specific circumstance or study backing up their assertions.

What this points to is that, given the lack of complete information or detailed independent studies on these matters, we could be  dealing with decisions under ignorance (as opposed to decisions under risk where we know all possible outcomes of a decision or decisions under uncertainty where we know the full probability space but cannot assign meaningful probability to all outcomes) where not even the probability space is known, i.e., we don’t really know all possible consequences, which is similar to what  Christoph Then pointed out as “non-reducible non-knowledge” or what Hillary Sutcliffe described as the probable  unknowability of cumulative effects. This is similar to former US Defense Secretary Donald Rumsfeld’s “unknown unknowns”, with more reason we should be taking the strong formulation of the precautionary principle in dealing with these matters.


2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?

Contrary to the earlier points made (#7202, #7205) lumping together the assessment of biodiversity to human health, I would suggest that these two broad categories (biodiversity conservation and sustainable use on one hand and human health on the other) should warrant distinct approaches in the assessment of potential benefits and risks,  as human  health is as much an important consideration distinct from the impact on conservation and sustainable use of biodiversity.

Looking closely at the much-vaunted forty years worth of positive regulatory experience relating to LMOs, this cumulative regulatory experience do not actually refer to LMOs being eaten directly by human beings and thus the direct effects or impacts of LMOs   on human health is not a foregone conclusion.  Given that we don’t foresee synbio products being eaten directly or being directly administered to humans for its human health applications in the immediate future,  with more reason that the risk assessment methodologies used on LMOs to assess  human health impacts should NOT be applied to synbio products, components or techniques when human health is under consideration.


3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

While I see merit in  ETC Group ‘s Jim Thomas enumerating the number  of affected farmers and other related impacts from one type of product and it being responded to in kind by Stephan Herrera of Evolva claiming contrary facts,  perhaps it is useful to look at other methodologies in dealing with these concerns, and to think through how CBD can deal with these impacts mindful that the CBD has no  provision dealing with  socio-economic impacts while the Cartagena Protocol may have a provision, art. 26, but it deals only with socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biodiversity, especially with regard to the value of biological diversity for indigenous peoples and local communities.

The CBD Technical Report No. 82 has an excellent and broader summation of these impacts in pages 49 and 50, found in Table 2 thereof, which cites examples of potential positive and negative impacts of synthetic biology with regard to social, economic and cultural considerations, with intellectual property and ethical considerations already integrated in the discussion and presentation.

What is clear from that Table 2 is that these socioeconomic and cultural impacts are of a different category altogether from the above two questions on impacts of synbio on conservation and  sustainable use of biodiversity and human health and there are robust methodologies in place, not only limited to technology assessment,  that can address these concerns, which can never be foreseen or addressed by the narrow and very specific case-by-case risk assessment methodologies under Cartagena Protocol.

In fact, the methodology I previously mentioned, on value sensitive design, can also help in minimizing the adverse impacts of any of the technologies of synthetic biology, for as long as the values hierarchy matrix developed for any of these technologies clearly spell  out the values, norms and design requirements of these technologies, all aimed at addressing, at the design phase of the technology, the possible adverse impacts of these technologies.

Another aspect that I would like the CBD to also consider in later stages of its discussion on these impacts is how the Parties which may be adversely affected by these impacts may be enabled, or assisted, using CBD mechanisms and processes, to address these impacts at the locus, or in the countries or regions or areas affected, of these impacts, or at the source or origin of the technologies that are causing these impacts.


Thank you for this opportunity and kind regards!
Elpidio
posted on 2015-06-06 05:30 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 7280 RE: Opening of the discussion on topic 4 [#7282]
Dear participants,

I thank our moderator  Dr. Casper Linnestad and all participants for their enlightening comments that have enhanced my understanding of the issues discussed.

As this discussion comes to an end, I echo the words of Stephen Herrera (#7228) that the spirit of this discussion is neither to polarize nor demonize, but to share different perspectives and clarify misunderstandings.

As many commentators stated, synthetic biology -- like all new and old technologies -- poses risks but also has the potential to bring many benefits to society. Yet, as Paul Freemont (# 7253), Panchapagesa Murali (#7272), and others pointed out in earlier posts, discussions with politically motivated opinions can lead to the same crooked path as the GMO debate. We have the chance to do things differently and avoid the confrontations and mistakes of the past.

In the spirit of clarification and sharing perspectives, it would have been useful for Dr. Swantje Strassheim from Germany (#7263) to substantiate her comparison regarding the applications arising from synthetic biology for contained used and GM crops.  She stated “It is therefore unlikely that those [synbio applications] will have negative impacts on human health, conservation and sustainable use of biodiversity, as has been seen with traditional GMOs over the last decade”.  The simple assertion that GMOs created the negative impacts she mentions is not borne out by the evidence.

In my 12 years of hands-on experience with GM maize in Honduras (including conducting socio-economic studies), and considering the vast available peer-reviewed literature published on the subject over more than 3 decades, I witnessed the opposite to what was stated by Dr. Strassheim:  high yielding, herbicide and insect–resistant GM crops have brought benefits to biodiversity conservation  and to farmers, including resource-poor farmers (I prefer this term to “peasants”). Since we are not discussing GM crops, I won´t include references as evidence.
  
Following Jaco Westra´s suggestion (#7204), our moderator invited us to make subdivisions to the broad questions. Many participants have stated that central to our topic of discussion of the potential risks and benefits of synthetic biology, we should consider these important issues:

1. Risk assessment and risk management

2. The Precautionary Principle and the perception of risk (novel technologies are often viewed with suspicion). This could lead to overly stringent regulation

3. Socio-economic considerations such as inclusion of stakeholders (including indigenous and local communities), and fair and equitable sharing of the benefits arising from the utilization of genetic resources, as stated in the Nagoya Protocol.

I will attempt a summary of posts regarding these 3 points and will share my own alternative perspective:

1. Risk assessment. Many participants discussed best practices for risk assessment (less so for risk management) in topic 5 and others have made summaries.

2.  The Precautionary Principle.

Many participants invoke the precautionary principle as the guiding principle of how we must proceed (Sorka Copa #7223, Christoph Then #7221 and others).  In my humble view, the precautionary principle can be interpreted – misinterpreted and even abused - in many ways. 

There is published evidence that overly stringent excessively precautionary regulation stalls science and innovation, especially in developing countries.  Or worse, drives it underground or make it the sole arena for industrialized nations and powerful companies. This happened with agricultural biotechnology and the mistakes can easily be repeated with synthetic biology. I know many researchers from developing countries working in public institutions, specifically on agricultural biotechnology, who are frustrated because their work cannot overcome unnecessary, over-stringent, and very costly regulation and cannot reach the intended users who need it most: subsistence farmers in their countries. 

Prohibiting the use of a technology doesn’t help either. I have seen GM corn seed, acquired legally in Honduras (the right legislation is in place), cultivated illegally by both small and big farmers in other Central American countries where it is prohibited by their governments, despite the ample evidence of its safety and benefits. Farmers use this technology because they see the benefits it brings, even if it is made illegal by their governments for political and ideological reasons.
 
An established truism in the discipline of risk analysis is “over-analysis leads to inaction” or “paralysis by analysis” – which may be the objective of some groups who oppose GMOs for ideological reasons.  The challenges of the 21st century demand urgent action with novel approaches, as stated by Bob Friedman (# 7244) referring to the fast development of vaccines to address pandemics.

I echo the statement by Genya Dana (#7227) regarding the Precautionary Principle that “the absence of information should not stop innovative research and development from proceeding” and support the notion of the “internationally accepted principle of taking the least restrictive measure possible to achieve reasonable safety objectives in the absence of evidence of likely harm”. 

In other words it would be risky and even dangerous to “do nothing until we have all the answers” (we will never have all the answers), or inforce unnecessarily stringent and costly regulation, as some participants have suggested.

Many, indeed most developing nations can´t comply with costly, overly stringent regulations based on a strict interpretation of the Precautionary Principle. An overly precautionary approach has had an adverse effect on the development and application of biotechnology in many developing countries.

As Paul Freemont reminded us (#7253) “most bench scientists are trained to carry out carefully thought experiments within their regulatory frameworks”. Parallel to technical developments, we also need to (and do!) instill values of justice, ethics, equitable sharing, and biosafety principles from the beginning and into the future, in our young students. Many initiatives and programs are already working on these issues (Human Practices Track on the iGEM competition). I may speak for more than one university researcher and mentor in this forum working with the future biotechnologists/synthetic biologists (iGEM students among them), including those like Todd Kuiken from the Wilson Center, who supports DIY communities (#7265).

3. Socio-economic considerations including inclusion of stakeholders and benefit sharing.

Participants concerned about “not considering the opinions of peasants, indigenous and local communities” include Silvia Ribeiro (#7206), Ricarda Steinbrecher (#7213) and Jim Thomas  (#7214). I also include myself in this group as I was born in a developing country and have lived and worked two thirds of my life in developing countries in Africa, South and Central America, and now in Mexico.  I recognize however, that I may have a different and privileged perspective from where I stand, and would like to advocate for another missing group of civil society, not represented at all in opinion and decision making processes:

“youth” – the students of today and our future professionals, many of which come from indigenous and “local” communities (not sure still what “local” communities mean in the CBD). 
Indigenous and “local” communities don´t necessarily want to remain “peasants” – poorly educated, poorly fed and housed, with poor health care, and with little access to technology. Many migrate to cities to seek a better life. The UN World Urbanization Prospects states that today, 80% of the population in Latin America and the Caribbean is urban, and predicts that all regions in the world are expected to urbanize further over the coming decades.

I see the glint in my student´s eyes (including those from indigenous and local communities) as they learn and realize they have a powerful technology in their hands. I also see that they have the energy and the passion of youth to do things differently than our generation did. They know it is their generation´s task is to “save the planet” and they know there is no time to waste. 

I also share the concerns of many commentators regarding benefit sharing for indigenous and local communities (Mathew Legg # 7260, Rosette Ferrer #7265, Katsiaryna Sidareak #7250, and Rachel Smolker #7242). My alternative approach regarding benefit sharing is:

“please give indigenous and local communities access to powerful technologies like genetic engineering and synthetic biology, so they too can find solutions to local problems”.

Think how cell phones or internet access have and continue to transform rural communities in developing nations. Think how synthetic insulin and artemisinin are helping millions of diabetics and malaria sufferers from indigenous and local communities the world over to have a better future.

The most powerful and efficient intervention for attaining SDG (Sustainable Development Goals) is education, especially for girls from rural and urban poor communities. I see this “benefit sharing” in our universities, with students (many are girls) from diverse backgrounds from many developing countries in Latin America and the Caribbean. They too are eager to use biotechnology and synthetic biology to bring solutions to their communities.  For example, iGEM students in Honduras are attempting to develop a vaccine for dengue fever. We must give them a chance and stop thinking that biotech and synbio are the realms of the big and the powerful alone. Like computers in the 70s, we are seeing the democratization and domestication of biotechnology.

This is indeed the time for the global community to engage in the fair and equitable sharing of the benefits from the use of genetic resources -- and powerful technologies.

I wish you all a pleasant weekend

Maria Mercedes Roca
posted on 2015-06-07 06:21 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7284]
I thank Casper Linnestad for being the moderator of this session and the Secretariat for the work on this.
Below are my feedback on the 3 questions posed:
1) What are the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity?
To make a risk assessment on the organisms and the resulting components and products arising from the synthetic biology, as some of the participants have pointed out (eg Nikolay Tzvetkov, #7201), which I agree, that without the proper comparator, it is rather difficult to make this decision. To quote my previous posting on the earlier session in this forum, it is reckoned that synthetic biology can be a double-egded sword, which it can bring both benefits and risks. But it is argued that this made it more compelling that the organisms and the resulting components and products arising from the synthetic biology should be subjected to the same Precautionary Principle in the Cartagena Protocol.

2) What are the potential benefits for and risks to human health that could arise from the components, organisms and products of synthetic biology?
For the assessment for risks and benefits to human health, my opinion is the same as aforesaid.

3) What are the potential socioeconomic impacts (positive and negative) from the components, organisms and products of synthetic biology?

In line with the Article 26 of the Cartagena Protocol, socioeconomic impacts should be part of the decision-making. But to illustrate, the socioeconomic impacts depends largely to the national risk assessment whether socioeconomic factors will be taken into account. Also, if it does, whether the impact is positive or negative, will depend on many other consideration eg. cultural values, faith practices, etc which can only be decided on case-by-case basis.

Thank you.

Regards,
Dr Kok Gan Chan
University of Malaya
Malaysia
posted on 2015-06-07 17:53 UTC by Dr Kok Gan Chan, Malaysia
This is a reply to 7284 RE: Opening of the discussion on topic 4 [#7286]
Once again, my name is Christoph Then. I work for the German NGO, Testbiotech.

I read with interest some of the critical comments made on my previous contribution in which I introduced a hypothetical genetically engineered organism, an insect, a fly that in its native form might have caused problems in agriculture. I suggested in my hypothesis that this organism would have artificial DNA that kills the female offspring but enables male offspring to survive. There would be no plan to terminate the life of these organisms once released (this is similar to an olive fly developed by the UK company, Oxitec). I further suggested that these hypothetical flies could act as “gene drivers”, changing the pattern of heredity in order to spread more rapidly into native populations (Gantz & Bier, 2015). Based on this hypothetical example, I suggested there should be agreement on clearly defined criteria that would allow the regulator to prevent the release of any such organisms. The reason I introduced this hypothesis is that there are too many gaps in our knowledge concerning long-term effects, and no possibility of ensuring adequate spatio-temporal control.

To the comment made by Bob Friedman: He wrote that he did not agree with my argument that such a hypothetical organism should never be released, because in his view genetically engineered mosquitos are needed to control malaria and other diseases. I would be happy to discuss this with Mr Friedman in regard to risks and benefits if need be. However, for the sake of argument, I have to say that the properties of the mosquitos that Mr Friedman means are very different to those of my hypothetical organism. At least the mosquitos that have been released so far ( also produced by Oxitec, but with different biological properties compared to the flies mentioned) are not meant to survive and do not act as gene drivers. So, whether someone is in favour of those mosquitos or not is irrelevant and not helpful in answering my questions.

Further, several experts suggested that there is no need to further develop the risk assessment currently used for genetically engineered organisms (LMOs). These experts should, however, be aware that even some of the scientists developing new methods, such as gene drivers, are asking for specific regulation of these new technologies and for a higher level of precaution in comparison to existing LMOs (see Gantz & Bier, 2015 or Ledford, 2015).

I agree that not all these questions are completely new. For example, there was an international call in 2014 for the CBD to take measures against spontaneous transboundary movements of genetically engineered organisms (http://www.stop-the-spread-of-transgenes.org/). This call shows that the problems of uncontrolled spread of genetically engineered organisms moving into the environment has not been solved in regard to the LMOs released over the last 20 years. But with the emergence of synthetic biology and synthetic gene engineering these questions are more pressing than ever. So in regard to the benefits and best practice for risk assessment, we have to face up to the actual developments and not seek to conceal them.

Any discussion about future applications of synthetic biology should clearly include those examples that may appear hypothetical at the moment, but which might become reality very, very soon. As mentioned in my first contribution, we can expect a high number of new organisms derived from synthetic genetic engineering to enter the environment. To quote in Ledford (2015), we need to be aware that humans have already hugely changed the biosphere of this planet. This alone should be a convincing reason to discuss the next steps thoroughly, before we put new burdens on to future generations simply because some stakeholders want to make a profit from new technologies within the period that a patent is valid.

Gantz, V.M., & Bier E. (2015). The mutagenic chain reaction: A method for converting heterozygous to homozygous mutations. Published Online March 19 2015, Science DOI: 10.1126/science.aaa5945

Ledford, H. (2015) CRISPR, the disruptor, A powerful gene-editing technology is the biggest game changer to hit biology since PCR. But with its huge potential come pressing concerns,  Nature, Vol 522, 20, 4 JUNE 2015
posted on 2015-06-07 19:07 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 7198 RE: Opening of the discussion on topic 4 [#7289]
Dear Casper Linnestad, Dear fellow participants,

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

First of all I would like to thank the CBD to have initiated this important online-dialogue on a subject that is highly complex and deserves a well differentiated discussion.

The heterogeneity of the field makes any risk and benefit evaluation of synthetic biology a challenging task, prone to misunderstandings and to debates that go astray. Confusion can arise not only with respect to what part of synthetic biology is being discussed, but also with respect to the underlying concepts being applied: the concepts, for example, of artificiality. And, most of all, we can anticipate developments only in very general terms. Having these problems in mind for the risk and benefit assessment of synthetic biology, I would like to pinpoint especially these areas of synthetic biology that go beyond genetic engineering by broadening the evolutionary realm. Particular in those cases our ability to predict potential risks to humans and biodiversity is limited by a lack of experience with comparable cases. We can gain some experience with research and a step-by-step approach, but in the cases of low familiarity to natural organisms, even this approach can bring along very limited knowledge within a relevant timespan. Thus to prevent acting under uncertainty with respect to risks to humans and biodiversity in the cases of low familiarity to natural organisms, the implementation of the precautionary principle is of special importance.

I also would like to refer to my post [#7288] under topic 5, where I describe limits to the case-to-case approach in synthetic biology risk assessment.

With kind regards
Margret Engelhard
posted on 2015-06-07 22:00 UTC by Ms. Margret Engelhard, Germany
This is a reply to 7264 RE: Opening of the discussion on topic 4 [#7290]
Dear Casper,

Very nice to see you at the helm of this round of discussion and thanks for the reminder that this round will end soon.

I just read the almost 100 pages of comments of fascinating exchanges, and I am very pleased with the multiple calls to stay focused and avoid polarisation.  I also concur with the suggestion by Westra and others to make some clear distinctions and definitions to allow the follow up debate to be more tangible.

Noting your plea to be concise, I share the following in response to the questions posed: 

• As the CBD report as well as the many posts in this round have illustrated, the potential benefits are many and very diverse, and potentially very significant, but to what extent these benefits will be realised may vary from case to case.
• Whether specific applications of the products of this technology also harbour potential risks can only be assessed case by case. 
• Most existing national and international biosafety regulations, such as the Cartagena Protocol, include such case by case assessments as a tool for informed decision making. 
• The current applications of SynBo involve the development or use of organisms that possess novel combinations of genetic material that go beyond natural physiological reproductive or recombination barriers, which means that those existing biosafety regulations apply.
• The risk assessment as outlined in Annex III of the Cartagena Protocol is at this point in time sufficient. That risk assessment takes into account the resulting organisms and, where appropriate, their products. It will be important to keep monitoring this field for points where the current risk assessment approaches need further development.
• The suggestion that the risk assessment in Annex III would be inadequate because the Cartagena Protocol only deals with transboundary movements, is incorrect, because that risk assessment also applies to decisions on domestic use (e.g. see article 11), and domestic regulatory frameworks must be consistent with the Protocol (see article 9).
• While socio-economic considerations are often best addressed on a generic level, article 26 of the CPB recognises that socio-economic considerations arising from the impact on the conservation and sustainable use of biological diversity can be taken into account in decision making, consistent with international obligations. In addressing the issue of ‘replacement’ it is indeed useful to take a holistic approach, including the impact on the environment and biodiversity of the current production practices that could be replaced.

Best regards to all

Piet van der Meer
posted on 2015-06-07 22:57 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 7289 RE: Opening of the discussion on topic 4 [#7291]
Dear  Online Forum

My name is Maria José Guazzelli, I am Executive Director of the Brazil-based Civil Society organization Centro Ecológico and a professional agronomist by training. Centro Ecológico has been following developments in the topic of Synthetic Biology for about 8 years, we have published reports and convened seminars on the topic and participated closely in international discussions both at the CBD and elsewhere. I am pleased to be able to contribute to this discussion and thank Dr Linnestadt for his moderation.

If I may, I would like to offer a perspective from Brazil - one that differs from the perspective offered by Brazillian government and Brazillian biotechnology supporters. Brazil is probably the country with the greatest amount of current  commercial activity in Synthetic Biology because of the role of the sugar industry in supplying feedstocks to this new industry. Synthetic Biology companies with production facilities or headquarters in Brazil include Amyris, Solazyme, Codexis, DSM, Gevo, BASF , Du Pont, Genomatica and others. In trying to understand the potential impacts of Synthetic biology-derived organisms, products and components Brazil can maybe be seen as an early test rat for what the development of a mature Syn Bio industry may mean for biodiversity and of socio-economic implications.

Expanding the sugar economy:  First what is clearest is that the Syn Bio industry so far has been closely tied to sugar and that this industry offers to create new markets and new value for sugar, thereby expanding sugar production in Brazil and elsewhere. By claiming to be able to turn sugar into everything from plastics, fuels, and bulk chemicals to new flavors, fragrances and cosmetic ingredients, Synthetic Biology lets the sugar industry reimagine itself as the new petrochemical industry - indeed as Alan Shaw of Codexis (now Calysta) put it “Sugar is the new oil”. Any consideration of the real world biodiversity and social impacts of Synthetic Biology needs to consider the impacts of expanded sugar production.

In Brazil we have already seen the negative impacts of accelerated expansion of sugar cane production. The rise in ethanol production has been at the expense of the Cerrado, the most biodiverse  savannah ecosystem on the planet.  Five percent of all species on earth are found in the Cerrado, many endemic, and this biodiversity is being harmed by intensive sugar mono cropping - including by extensive use of agrochemicals, habitat fragmentation and by massive greenhouse gas release when cane stalks are burned or land is cleared and soil disturbed. Additionally the conversion of former soy farms to sugar production is displacing those industries (soy, cattle) deeper into the Amazonian forest. There are also extensive and well documented negative social impacts from sugar production where the conditions experienced by laborers in the sugar cane fields includes very low wages as well as significant health risks from long term physical labour and use of agrotoxins.  In this way a key negative ‘indirect’ impact of Syn Bio expansion will be sugar expansion and all that accompanies that. This must be accounted for in any assessment.

Spills, leaks and contamination: Secondly I would like reiterate the observation that, if and when commercialized , there is no true ‘contained use’ for Syn Bio organisms.  For example in March 2013 the U.S. company Amyris reported to CTNBio (Brazilian Biosafety Committee) about an accident at one of its facilities in Brazil. About 20 liters of a solution containing transgenic yeast leaked into the environment. The microorganism was developed for “confined" use for the production of diesel from sugar cane. According to the company, appropriate measures were taken to contain the spill on this occasion but we can only assume that there are other ongoing and unreported spills and accidents - as well as likely ingression of  traits in the environment. Because of human error - either run understanding risks or handling living organisms, commercial use should be regarded as effectively equivalent to a release scenario. We do not believe work has been done to properly assess likely biosafety impacts resulting from spills.

Finally, I would like to give a specific example of a group of rural workers who may be harmed. Brazillian Babassu is an oil plant similar to palm oil that grows widely in the States of Maranhão and Piauí and is high in lauric oils such as lauric acid and myristic acid. Babassu is primarily harvested and processed by women co-operatives who crack the nuts and sell to oleochemical producers. In Brazil, Babassu is a key oleochemical source for soaps, detergents etc. Last year multinational company Unilever began using a Syn Bio-derived myristic oil grown in vats of sugar-fed algae by Solazyme inc. This was used in Unilever’s Palmolive soap in Brazil. We do not have data about whether this impacted babassu prices or market but such substitutions might impact the “quebradeiras de côco” livelihoods and ways of life (which in turn impacts biodiversity) and the Syn Bio companies are also substituting one reasonably low impact feedstock (babassu is a wild seeded tree) with another known to have significant issues - monoculture sugar.

I hope these are useful observations from the country that is the lab rat for this new industry.

Yours Sincerely Maria José Guazzelli.
posted on 2015-06-07 23:05 UTC by Ms. MariaJose Guazzelli, Centro Ecológico