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Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7311]
POSTED ON BEHALF OF BENSON KINYAGIA
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Dear Members of the Open-Ended Online Forum,

Welcome to the next round of discussion on synthetic biology, taking place with the view to achieve elements of decision XII/24.

In line with the calendar of activities, this round of discussion will focus on the Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques.

Building on the views shared during the previous rounds of discussion, and in particular the interventions posted under topic 2 on similarities and differences between living modified organisms (as defined in the Cartagena Protocol) and organisms, components and products of synthetic biology techniques (https://bch.cbd.int/synbio/open-ended/pastdiscussions.shtml#topic2), I would like to invite you to consider, within the mandate of the Convention and its Protocols:

1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?
2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

To assist in the discussion, the Secretariat has made available the relevant sections of the CBD Technical Series no. 82 on Synthetic Biology as background documents (Pages 76-111; available at http://bch.cbd.int/synbio/cbd-ts-82-en_topic6.pdf). 

I kindly request that you keep your interventions succinct and concise with focus on the topic of discussion. Furthermore, please avoid  repeating information that has already been posted in previous rounds.

Once again, thank you for your time and efforts in supporting the work of the Open-Ended Online Forum on synthetic biology. I look forward to your insightful interventions.
Best regards,
Benson
posted on 2015-06-22 01:42 UTC by Dina Abdelhakim, SCBD
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7318]
I am Taye Birhanu, a researcher at the Ethiopian Biodiversity Institute, Ethiopia. Thank you for the BCH secretariat and moderator for coordinating this online forum and for allowing me to participate in the forum.
In my opinion, the National Biosafety Framework (NBF) is one of the instruments to address the objectives of the CBD protocols. Although Biosafety in Cartagena protocol comprises of policy, legislative, administrative and technical instruments that have been developed in order to ensure an adequate level of safety in the field of the safe transfer, development, handling and use of Living Modified Organisms (LMOs), also referred to as Genetically Modified Organisms (GMOs) and their products that emanate from modern biotechnology. It can also be revised to Synthetic Biology organisms with regulatory regime which is based on the Precautionary Principle set to protect human and animal health, biological diversity and the environment at large by preventing or managing down to levels of insignificant the adverse effects of Synthetic Biology  derived Organisms, components,  products and thereof .
(edited on 2015-06-24 12:02 UTC by Mr. Taye Birhanu)
posted on 2015-06-24 11:09 UTC by Mr. Taye Birhanu, Ethiopia
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7321]
Thanks to Secretariat and Moderator for this new round of discussions on Topic 6 which hopefully led to some improvements but less participation of the experts due to the very nature of the issue and also because many things have been already said.
Regarding the International Instruments that regulate the organism, components or products I would like to add one more to the list cited by the Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82, page 76:

The 1925 Geneva Protocol:

Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or other Gases, and of Bacteriological Methods of Warfare. Signed at Geneva, June 17,1925.

To the end that this prohibition shall be universally accepted as a part of International Law, binding alike the conscience and the practice of nations;
DECLARE:
That the High Contracting Parties, ……….. agree to extend this prohibition to the use of bacteriological methods of warfare and agree to be bound as between themselves according to the terms of this declaration.

Finally with regard to National instruments, the Republic of Cuba has a position and a legally binding regime applicable to this issue:

As for Biosafety refers as policy, the National Biosafety Center does not prohibit, but controls, activities related to the development of new technologies in the biological sphere in general, including synthetic biology in particular, and
others that are to be developed on a future.
Current legislation, led by Decree Law 190/99 of Biosafety and several resolutions of the Ministry of Science Technology and Environment applies to a high percentage of the applications in which synthetic biology is involved, to conceptualize broad and lasting manner over time different categories of living organisms, among them:

Biological Agents: viable microorganisms or their products, prions and other organisms that cause or may cause diseases to man, animals and plants.

Genetically modified organism:  An organism whose genetic material has been modified by man differently to natural.

In principle, all activities involving biological agents, components and products resulting from synthetic biology that may pose risk to human health and the environment should be subject to rigorous risk evaluation process, from the very beginning, as a prerequisite for approval to continue, regardless of their intended peaceful use.

Kind regards,
L. Regalado
(edited on 2015-06-28 13:08 UTC by Mr. Lazaro Regalado)
posted on 2015-06-25 07:43 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7322]
POSTED ON BEHALF OF SATURNINA HALOS
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This is Saturnina C. Halos from the Philippines where I have served the Department of Agriculture formulate regulatory policies for genetically engineered organisms since 2002. For products of synthetic biology that can reproduce and of which its DNA has been altered in accordance with the definition of modern biotechnology and LMOs in the Cartagena Protocol on Biosafety (CPB), I agree that any regulatory framework developed to implement the CPB also applies. For non-living products of synthetic biology, these may be regulated according to their use of which there are already existing regulatory systems; e.g. medical use - pharmaceuticals regulation; pesticide use - pesticide regulations, etc.
posted on 2015-06-25 14:19 UTC by Dina Abdelhakim, SCBD
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7324]
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.

We will provide information on national instruments that exist to regulate the organisms, components, or products derived from synthetic biology techniques.

In New Zealand, the Hazardous Substances and New Organisms Act (HSNO Act) 1996 would likely regulate organisms produced through synthetic biology. This Act regulates both new organisms (including GMOs/LMOs) and hazardous substances (with defined intrinsic properties).
‘Outputs’ of synthetic biology techniques may be regulated by the HSNO Act if they come within the definition of an ‘organism’ and ‘new organism’ in the Act. ‘Organism’ is widely defined in the Act and includes a genetic structure (other than a human cell) that is capable of replicating itself, whether that structure comprises all or part of the entity. The definition of ‘new organism’ includes organisms belonging to species that were not present in New Zealand prior to July 1998 and GMOs. The definition of a GMO is very broad (organisms whose genes or genetic material have been modified by in vitro techniques). However, regulations may provide that certain organisms are not GMOs.

If there is uncertainty about whether an entity is a GMO (or even an organism), there is a formal determination the New Zealand Environmental Protection Authority can undertake pursuant to the HSNO Act.

Regarding the regulation of products or components of synthetic biology, possible regulation under the HSNO Act depends on the intended use of the substance. Under the HSNO Act, a substance is classified as a ‘hazardous substance’ if it meets the threshold defined by the ‘hazard classification system’. Whether or not the substance comes from a natural source is irrelevant (synthetic chemistry is a well-established field of science), and the threshold relates to the particular compound as well as the concentration. Classification of a substance as a ‘hazardous substance’ depends on an assessment using the ‘hazard classification system’. Specifically, the associated toxicity data package is assessed.

The HSNO Act contains a risk assessment and risk management framework which considers both environmental and human effects.

We expect that the HSNO framework is adequate to address the potential impacts on the objectives of the Convention and its Protocols in the New Zealand context.

Thank you again for the opportunity to provide input.

Kind regards,
Mariska Wouters
New Zealand Ministry for the Environment
posted on 2015-06-26 05:00 UTC by Ms. Mariska Wouters, New Zealand
This is a reply to 7324 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7328]
I would mention that at the national level in Moldova the Synthetic biology is not covered by a specific law.  The living modifies organisms are regulated by the Law on Biosafety (2001) in acordance with Cartagena Protocol on Biosafety and the pesticides and plant protection substances are supervised by the Law on Plant Protection and Phytosanitarian Control (2010).
There is no any regional agreement in the CEE that is responding to the Syntetic biology rules.

At the international level along with the Cartagena Protocol that is dealing with the leaving modified organisms and its transboundary  movement, there is a number of other agreements listed well in the CBD Syntetic Biology technical series. However, there is a gap that not all the SyentBio products and organisms are covered by the existent documents, as well as the specific impact to the biodiversity conservation and sustainable use of bio resources has not been considered at the international and national levels. In my opinion, a new agreement (protocol) should be discussed and developed under the CBD/CPB, as well as a specific guideline should be prepared on this specific topic.

Best regards,

Angela Lozan
Moldova
posted on 2015-06-28 08:33 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7331]
POSTED ON BEHALF OF BENSON KINYAGIA
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Dear Forum Participants,

We are now a week into our discussion on the Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques and I would like to thank participants who have shared their views with us so far. I would like to encourage more participants to share their views with us over the next few days, prior to the closing of the discussion which is scheduled for Monday, 6 July at 1:00am GMT. It is important to have a broad spectrum of views on the matter which will be forwarded for consideration by the  AHTEG at their upcoming meeting.

It is also important to ask hard questions on the impacts on conservation and its valuation by products developed  without using natural products to replace the natural  one and whether the current instruments whose focus in many State Parties has been on GMO’s and ABS have adequately addressed possible impacts from organisms, components or products derived from synthetic biology techniques

Once again, thank you for your time and efforts in supporting the work of the Open-Ended Online Forum on synthetic biology. I look forward to your insightful interventions.

Best regards,
Benson
posted on 2015-06-29 16:27 UTC by Dina Abdelhakim, SCBD
This is a reply to 7331 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7332]
Dear participants,

I think at this point the SynBio AHTEG will be very important to establish the concept and the framework, based on the various topics and weeks of discussions in this on line forum. As many other participants I believe we have a very well structured basis for this work paved by experience and regulations with GMOs.

Regarding the existence of national instruments in Brasil the biosafety legal framework is established according to the Law 11.105/2005(http://www.ctnbio.gov.br/index.php/content/view/12847.html) and Decree 5591/2005 (http://www.ctnbio.gov.br/index.php/content/view/12848.html) and the same principles could be applied for risk assessment of SynBio. Also some specific normatives for research activities, commercial release and monitoring could be applied for SynBio(http://www.ctnbio.gov.br/index.php/content/view/12845.html).

Best regards,
Luciana P. Ambrozevicius / Ministry of Agriculture
posted on 2015-06-29 20:41 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 7332 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7333]
My name is Paul Freemont and I am a Professor at Imperial College London and co-director of the Centre for Synthetic Biology and Innovation and nation UK Innovation and Knowledge Centre for Synthetic Biology.

I am honoured to be part of this online Forum, which has been excellent in coalescing the many different viewpoints from global stakeholders on Synthetic Biology in relation to the CBD.  Whilst I do not want to repeat my previous posts I do agree with forum members (#7327; #7332, #7330) who have suggested that a broad dialogue on the technical aspects and risk and socioeconomic considerations is warranted to address Topics 6 and 7. It is clear form the many posts that there are regulatory frameworks in many different countries on LMO’s and more generally biotechnological produced products (e.g. #7324, #7332). It is also clear that at the international level there is some need to develop more discussion on regulatory frameworks (#7328). It would be extremely helpful if all of existing regulatory frameworks were openly shared and discussed in relation to synthetic biology with best practise and gaps identified (this could address the points made in #7319, #7320). This could also lead to some common definition/s on synthetic biology and common ground on any current or future potential impacts of synthetic biology on biodiversity.

Thus to answer the question of the post as to whether there are broadly adequate frameworks in place internationally, there does appear to although there are differing levels of implementation. For the UK this is coordinated by the HSE (e.g. see http://www.hse.gov.uk/biosafety/index.htm), which as a member state is aligned with the EU (e.g. see http://ec.europa.eu/food/plant/gmo/new/index_en.htm). Although as stated above further discussions between members of the Forum and sharing of best practise from the various international regulatory structures would be extremely valuable for the global development of synthetic biology
posted on 2015-06-30 14:03 UTC by Mr. Paul Freemont, Imperial College London
This is a reply to 7333 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7334]
Once again, my name is Christoph Then. I work for the German NGO, Testbiotech.

Both questions (regarding the degree to which existing arrangements constitute a comprehensive framework and the adequacy of existing instruments to regulate synthetic biology) can be explored by using the hypothetical organism I introduced previously. This hypothetical synthetic organism is a fly that if released is designed to kill the female offspring in native fly populations, whilst allowing male offspring to survive. There would be no plan to terminate the life of these organisms once released. Further, these hypothetical flies could be designed as a “gene driver”, changing the pattern of heredity in order to spread their synthetic DNA more rapidly into native populations (Gantz & Bier, 2015).

I am not aware of any national or international framework or instrument that would allow a global ban on such organisms being released. Most regulatory frameworks and risk management instruments would first require a risk assessment and then, based on available evidence and/or plausibility, would be decided on by each country on an individual basis – whilst the flies could in the meanwhile be spontaneously crossing boundaries.

In fact it would be very difficult to assess the possible threat of a significant reduction or loss of biodiversity in more detail. Indeed, a synthetic organism once released might lead to the extinction of a whole specific target species. Some stakeholders would argue that this is the intended result of releasing the organism and would even see it as beneficial if, for example, an agricultural pest could be eliminated.

However, the real and long-term impact of the extinction of species on overall biodiversity is almost impossible  to assess. Furthermore, the length of time until the species was extinct would be by no means certain – it might take years or never actually happen. This means that the organism carrying the synthetic DNA would remain in the environment for an undefined (and maybe unlimited) period of time, and would therefore become part of the evolutionary processes. Consequently, such an organism can become a threat to the environment in way that cannot be predicted at the time of its release.

In general, it is more or less impossible to predict the long-term ecological impact of any synthetic organism that escapes spatio-temporal control. In addition, its impact might be exacerbated by genetic re-arrangements and newly occurring mutations in interaction with environmental (biotic as well as abiotic) changes. Evolutionary processes make it possible to turn events with a low probability of ever happening into events that may feasibly happen.

Some of these questions were addressed in the international call made in 2014 for the CBD to take measures against spontaneous transboundary movements of genetically engineered organisms (http://www.stop-the-spread-of-transgenes.org/). A need for regulatory action was identified in the call:

“From a regulatory point of view, spatio-temporal control of genetically engineered organisms is necessary. It is a fundamental precondition for any risk assessment because no reliable predictions can be made concerning the consequences of artificially transformed organisms once they are released or escape into wider environments and become part of open-ended evolutionary processes.

(….) The precautionary principle can only be implemented if genetically engineered organisms can be retrieved from the environment in case of emergency. This becomes impossible once transgenes move and accumulate in wild and landrace varieties.”

The call was made in regard to the gene flow into native populations of transgenic plants already  being cultivated. A heightened awareness of the potential of synthetic biology and synthetic gene engineering makes the need for regulatory action seem more pressing than ever. There will without doubt be more and more new organisms / products appearing within shorter periods of time. For biodiversity this implies that there could be a dramatic increase in the number of different technically derived organisms released into the environment within the next few years. Therefore,  the likelihood of negative consequences will also increase - not only stochastically. We have to assume an increasing level of uncertainty and a decreasing level of predictability. Risk assessment will necessarily suffer from a substantial amount of non-reducible non-knowledge (see Boeschen et al, 2006), especially if we have to deal with synthetic organisms that can escape spatio-temporal control.

Thus, the only way to tackle these questions is to strengthen the precautionary principle, which is the basis of both the CBD and Cartagena Protocol. The way in which the precautionary principle is currently applied appears to be almost inadequate. Much stronger instruments would be needed to allow a global ban on the release of any synthetic organisms (as well as transgenic organisms) that cannot be controlled in their spatio-temporal dimension, and which might even spontaneously move across boundaries between the member states of the Cartagena protocol.
posted on 2015-06-30 19:17 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 7331 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7338]
Greetings.  My name is Jim Louter and I work as a biotechnology risk assessor at Environment Canada.

Replying to Bensons's first post regarding the questions posed at the beginning of this discussion:
1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?
2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

Broad questions indeed and dependent on the definitions we discussed earlier on.  Like New Zealand, Canada has an approach based on ‘novelty’ or ‘new’ which is agnostic to the method used to make the organism ‘novel’ or ‘new’ and therefore, living products of synthetic biology, however it comes to be defined, will be captured. In Canada, this would include the Canadian Environmental Protection Act 1999, the Seeds Act, the Feeds Act, the Fertilizers Act, the Health of Animals Act (for veterinary biologics) and the Pest Control Products Act.

Again, as said before, the ‘non-living’ products of synthetic biology will be captured in Canada by regulatory regimes designed for certain end-uses or by regimes designed to regulate chemicals.  There could be some discussion here about ‘short-lived’ organisms that are products of synthetic biology but I believe these would be addressed in Canada by the laws I’ve mentioned above.

These instruments are sufficient to address environmental aspects in Canada including the potential for adverse effects on biological diversity.

Jim Louter
Environment Canada
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=E621534F-1
posted on 2015-06-30 20:05 UTC by Mr. Jim Louter, Canada
This is a reply to 7338 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7340]
We agree with those who have stated earlier on this forum that synthetic biology is not a new or “untested” branch of biotech that requires a whole new or separate set of legal instruments and evaluation tools. This is not to say that there is no point in having a regular review of these instruments to determine their adequacy. Like all forms of biotechnology protocols, we DO very much need to constantly be asking ourselves: Are we thinking sufficiently big picture? Are we missing anything? Have all stakeholders been allowed to raise questions and concerns? Are rule makers considering all viewpoints fairly? Are we having an intellectually honest and evidence-based conversation about what we know (and don't know) about synthetic biology regulatory regimes and instruments?

An enormous amount of time and resources have already been invested around the world in country capitals to get at the answers to these questions.

As a result, ALL forms of biotech are highly regulated throughout the world, not least in Switzerland, Denmark, the UK, India, and the US, where Evolva has operations. All of these countries have a long history with biotechnology. Synthetic biology is not new to any of these countries.

As a result, there are comprehensive instruments already in place in all of these countries—and everywhere else in the world where biotech is being advanced and leveraged—to regulate ALL aspects biotechnology. These instruments are "adequate" to address the potential impacts of synthetic biology on the objectives of the CBD and its Protocols.

Sincerely,
Stephan Herrera
Evolva



Sincerely,
Stephan Herrera
Evolva
posted on 2015-06-30 21:38 UTC by Mr. Stephan Herrera, Evolva
This is a reply to 7340 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7341]
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. I am pleased to join the discussion on the forum, and thank the moderators for their work and the thoughtful comments of the other participants in the forum.

The United States believes first and foremost that regulation and oversight of emerging technologies should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers. Regulation and oversight should be based on the best available scientific evidence, and with an awareness of the potential benefits and the potential costs of such regulation and oversight. Any measures taken should have sufficient flexibility to accommodate new evidence and learning and to take into account the evolving nature of information related to emerging technologies and their applications.

The United States has a coordinated, risk-based system to ensure that biotechnology products, whether through their use, research or production, and including those obtained using biological engineering, are safe for the environment and human and animal health. This system describes an approach to the oversight of planned introductions of biotechnology products into the environment that focuses on the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created.

Established as a formal policy in 1986, under the auspices of the Office of Science and Technology Policy (OSTP) in the Executive Office of the President, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating the safety of products developed using modern biotechnology. For example, in the case of genetically engineered plants, the U.S. agencies responsible for oversight of the products of agricultural biological engineering include the Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). To consider another example, FDA’s regulations for pharmaceutical approvals apply in the case of using genetically engineered microorganisms to produce recombinant human insulin – a product of biotechnology that was first licensed in 1980.

Using the current laws and regulations, the United States can address a range of biological engineering products. The United States re-evaluates its regulations and approaches as new information and techniques become available.

Internationally, biological engineering products fall under a range of already existing oversight mechanisms; additional oversight activities under the Convention are unnecessary. Safety with respect to the health of plants, animals, and humans is already addressed under the Codex Alimentarius, the International Plant Protection Convention, as well as cooperative efforts under the World Health Organization, and the Organization for Economic Cooperation and Development. These international fora rightly do not base their oversight on biological engineering techniques, but instead on the nature of the product and its intended use.
posted on 2015-06-30 22:09 UTC by Ms. Genya Dana, United States of America
This is a reply to 7340 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7344]
I am representing the Association of Biotechnology Led Enterprise from India which is the Industry body of the Biotechnology Industries. I agree with Stephan Herara and the other writers of this post that there are enough and more regulations around the world. What is needed is to continue to carefully monitor using the existing guidelines.
posted on 2015-07-01 02:27 UTC by Mr. Murali Panchapagesa Muthuswamy, Association of Biotechnology Led Enterprise (ABLE)
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7346]
My name is Jean Roger Rakotoarijaona, I am Madagascar BCH national focal point. Thanks a lot to the Secretariat for this opportunity.
Madagascar is concerned by the risk of loss of biodiversity associated with synthetic biology. It is not certain that the biosecurity framework that we are putting in place will suffice to take into account synthetically modified organisms. But this question is crucial especially for the economy of Madagascar in particular and that of developing countries in general, because our economies heavily depend on natural resources based exports.
The texts in force and the structures in place at national level do not protect us enough against biopiracy. So that our wealth in genetic resources are regularly looted and all data to synthesize our plants are in the hands of multinational companies that allow them to make biological copy legally.
Internationally, although the Convention on Biological Diversity recognizes the risk of unfair trade (UNEP/CBD/SBSTTA/18/10 para 22), there is no arrangement under which intellectual property on genetic resource is protected and right to copy and market synthetic products is framed. This is very detrimental for poor countries as demonstrated by several studies. Risk assessments done in the biotechnologically-advanced countries do not take into account the impact of their technologies on the developing countries which constitute the original source of raw materials. It is not only a matter of livelihoods of cash crop dependent people but the survival of the economy is at stake.
The CBD, under its objective of fair and equitable sharing of benefits arising out of the utilization of genetic resources, should collaborate with WHO and other involved international organizations and conventions to find a solution to at least put in place adequate safeguards as well as an appropriate international legal framework that would protect against biopiracy and unfair trade regardless of the definition of synthetic biology and genetic resources.

Regards.
posted on 2015-07-01 07:00 UTC by Mr. Jean Roger Rakotoarijaona, Madagascar
This is a reply to 7346 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7347]
Hello, I am Hilary Sutcliffe from a UK not-for-profit called MATTER which explores Responsible Innovation.

I would be interested to hear a response to the question on BioPiracy from Madagascar.  It is clearly very difficult to stop a supposed holiday maker pocketing a small plant or insect and surely little traceability there?  How would something like that be regulated or if already in the protocols how would it be traced, monitored and policed?  Similarly individual medical issues presumably have the same issues, a hair is easily got - is this enough?  It seems to me that these have been aired but not resolved adequately?

Impacts on livelihoods is also another very tricky area - how is this dealt with by current concepts outside reputational pressure from NGOs?  Does the right of a small company, say in a developing country, to develop a product to respond to a need which can be more sustainably addressed by biotech trump the livelihood of a farmer producing the product?  Who says? 

With regard to the interesting case study from Testbiotech I felt that might be covered by existing health and safety rulings - but again relies on assumptions about interactions which cannot be easily mapped in advance - does anyone have views on that?

It might be useful to consider, as they have done, individual case studies, which might illustrate gaps, not just in oversight, but probably more importantly, in the ability to adequately monitor and enforce regulation or protocols? 

Hilary
posted on 2015-07-01 08:14 UTC by Ms. Hilary Sutcliffe, MATTER
This is a reply to 7347 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7348]
Dear all

In so far as organisms resulting from synthetic biology techniques meet the definition of living modified organisms (LMOs) under the Cartagena Protocol on Biosafety, then they are also LMOs and should be regulated accordingly, including under the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The Cartagena Protocol however, only addresses products thereof under its Article 20, Annex I and Annex III, so its scope is limited in relation to components and products of synthetic biology.

As the organisms, components and products of synthetic biology techniques make up a broader category than LMOs as defined under the Protocol, there is an urgent need for their adequate regulation at national, regional and international levels, with a boarder definition of this application of modern biotechnology (as defined under the Cartagena Protocol and the Codex Alimentarius Principles for the Risk Analysis of Foods Derived from Modern Biotechnology), and explicitly including products of genome editing technologies.

Moreover, while the existing processes under the Cartagena Protocol and Codex Alimentarius largely (but not exclusively) focus on risk assessment, there is a lack of national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques that at the same time comprehensively include socio-economic impacts and the issue of liability and redress.

I agree with others that there would need to be synergy in the work of the proposed AHTEG on Synthetic Biology and the existing AHTEG on Risk Assessment set up under the Cartagena Protocol, in regard to the topic of synthetic biology. 

kind regards
Lim Li Ching
Third World Network
posted on 2015-07-01 09:04 UTC by Ms. Li Ching Lim, Third World Network
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7349]
Dear Colleagues,

Once again I welcome the opportunity to add to this discussion. My name is Jaco Westra from the Dutch National Institute of Public Health and the Environment.

As has been put forward frequently also in the other discussions:  judging the present state of affairs in synthetic biology – the current regulatory framework in the EU, including the framework work for risk assessment are considered adequate. This is true for synbio organisms, components and products. That is the systematics and the way of thinking as we know it now and use it now are still functional, also in the foreseeable near-term future.

There are some aspects that do deserve further attention:
- we need to assess if and at what point our current instruments (regulation, risk-assessment, overall systematics) are no longer fully adequate.
- The context being that synthetic biology is developing fast, so we need to monitor these developments closely to be able to judge the validity of our thinking and frameworks
- From the product side we need to keep an open eye for example the production of low volume chemical substances as they are only covered to a limited degree by e.g. the EU chemical substances regulation (REACH).
- Additionally, chemical substances and product regulations have no (or indirect at best) objectives referring to e.g. biodiversity. That is the potential impacts of ‘components’ and ‘products’  on the objectives of the Convention and its protocols are unclear and may need some closer scrutiny.


Looking forward to more illuminating discussions,

Jaco Westra
RIVM
The Netherlands
posted on 2015-07-01 12:31 UTC by Mr. Jaco Westra, Netherlands
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7351]
Dear Colleagues

I'm Mike Paton from the UK Health and Safety Executive. Many thanks for the opportunity to contribute to this topic on the adequacy of the regulatory framework for synthetic biology. A number of the points have been raised by others and in previous topic discussions.

In the UK, for the purposes of regulation, synthetic biology is considered to be an extension of genetic modification or modern biotechnology. Consequently, it is regulated in the same manner. That is, where it involves organisms in laboratories (or contained conditions), the Genetically Modified Organisms (Contained Use) Regulations 2014 apply(1); and where it involves organisms for experimental or marketing authorisation to release into the environment,  the Genetically Modified Organisms (Deliberate Release) Regulations 2002 apply (2). Before an organism could be released into the environment, the regulatory process involves initial research & development in contained use. Evidence established would then be used inform the risk assessment and monitoring, for any proposed controlled experimental release application. Once authorised, the experimental release will generate evidence and data to inform an application for market authorisation. These national regulations implement, European Directives 2009/41/EC and 2001/18/EC respectively (3).

The regulations are enforced by national regulators that includes technical review of advanced notification of proposed work, laboratory inspections and where necessary holding organisations accountable through criminal proceedings. In addition, this is ‘policed’ locally by Principal Investigators, Institutional Biosafety Committees and peer review set against a background of responsible innovation and research ethics. Some of this work also falls within other security related legislation and other international obligations via the UN, WHO and BTWC and is therefore subject to further regulatory oversight.

For non-living products of synthetic biology, similar to non-living products of genetic modification or biotechnology, these are regulated in a sectorial manner. That is, there are specific processes and procedures tailored to that industry or sector through which the product has to progress to reach the market – these are tailored to individual end-uses. For example, human or veterinary medicines are authorised through the European Medicines Agency (4), which have authorised 13 recombinant veterinary medicines; and 12 human recombinant medicines  as well was >100 orphan recombinant products for rare diseases.  The EC scientific opinion II on synthetic biology (5) estimated  >30 different end-uses envisaged for products of synthetic biology and each of these may have specific regulatory processes or procedures to bring the products to market.

These existing regulatory regimes are therefore considered to be adequate and fit for purpose in managing risk to human health and the environment. There are currently no specific examples of living products of synbio that would not be captured by a regulatory framework in the EU. The protection goals of EU and national legislation are consistent with the objectives of the CBD and its Protocols without the need for further regulation.

(1) http://www.legislation.gov.uk/uksi/2014/1663/contents/made
(2) http://www.legislation.gov.uk/uksi/2002/2443/part/I/made
(3) http://ec.europa.eu/health/files/eudralex/vol-1/dir_2009_41/dir_2009_41_en.pdf; http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32001L0018
(4) http://www.ema.europa.eu/ema/
(5) http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_048.pdf
posted on 2015-07-01 13:34 UTC by Mr. Michael Paton, United Kingdom of Great Britain and Northern Ireland
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7352]
Dear forum participants,

Thank you all for this opportunity to add a few thoughts to the discussion on the adequacy of existing instruments.

Firstly, I must say that a few talking points seem to have been repeated a great many times in multiple topics of this forum primarily by biotech industry representatives (whose conflict of interest has been pointed out previously [#7242]). These include that:

a) biotechnology has been "used safely for more than 40 years" and synthetic biology does not represent any meaningful change from previous biotechnologies in terms of level of risk or need for regulation; and

b) our discussions are focusing disproportionately on risks while failing to name benefits.

With regard to a) I would question the extent to which certain new synthetic biology techniques and applications such as CRISPR/Cas9 or the scenario described by Christopher Then [#7334] can be said to be demonstrated as "safe" simply because 40 years ago other biotechnology techniques existed. I feel this is a misrepresentation of the degree of change, and join many who believe it is so significant that it represents a "step change" in biotechnology.

With regard to b) it seems to me an inaccurate assertion if only due to the number of times it has been made followed by naming potential benefits of synthetic biology! I agree that there may well be benefits derived from synthetic biology and I do not feel that that negates the need to honestly named the risks.

CBD Technical Series 82, Page 80 mentions that synthetic biology has been identified as a "potential existential threat". Now, recognizing that that is a worst-case scenario, even the fact that it cannot be ruled out seems to me to highlight the need for a very robust and precautionary approach. The regulatory response to synthetic biology is clearly impacted as well by the reality that the risks posed by certain applications of synthetic biology (e.g. gene drives, invasive species, bioweapons) will not respect national boundaries. Even if most States develop robust and appropriate mechanisms for regulation, if even one State fails prevent the release of a dangerous synthetic biology organism, product, etc., the results may be extremely difficult to contain as mentioned by Christopher Then.

Given this reality, I do wonder, in spite of the many comments that existing regulatory instruments are sufficient, if that is really the case. What I've read thus far sounds like an inadequate, inconsistent and complex patchwork of national and international regulations with many different laws applying depending on the definition and application of "synthetic biology" in question. I fear this may be too slow to respond to real world situations as products of synthetic biology increase exponentially.

Sincerely,
Matthew Legge
Canadian Friends Service Committee (Quakers)
posted on 2015-07-01 14:55 UTC by Mr. Matthew Legge, Canadian Friends Service Committee (Quakers)
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7353]
Dear forum participants,

I’m Valentina Rastelli from the Italian Institute for Environmental Protection and Research. My opinion is that, until knowledge gaps and a clear definition of synthetic biology will not be on the shelf, it seems reasonable to apply current risk assessment procedures and monitoring regimes performed for LMOs releases and applications, together with those used for medical, chemical products and other activities that may have impacts on biodiversity. I’m referring in particular to the European Union legislative frameworks for the aforementioned fields, because I have a direct knowledge of them. I want to add that it is also reasonable that some modification to those procedures could be needed. Indeed, for example, for some of the organisms designed and constructed in the laboratory with chemically synthesized DNA, there is no “parental organism” to be compared with, and identifying a reference organism is one of the most critical point for the risk assessment procedure. So, further in-depth analysis on this issue, as on other issues, could be useful.
Kind regards to all,

Valentina Rastelli
posted on 2015-07-01 15:46 UTC by Ms. Valentina Rastelli, Italy
This is a reply to 7353 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7357]
Dear all,

I agree with others that  the existent national, regional and international instruments are not sufficient to regulate all kinds of organisms, components and products from synthetic biology engineering (##7353, 7352, 7348, 7348).

The AHTEG on SynBio should provide with clarity on definition, as it covers not only genic engineering of living modified organisms, and also products and chemical engineering of DNA,  that are not fully covered by the international agreements and standards. The synthetic biology techniques make up a broader category than LMOs as defined under the Cartagena Protocol, Codex Allimentarius and/or other international  agreements.

While some of participants consider that their countries (mostly developed countries) have a very efficient system of regulation and risk assessment for this kind of biotechnology, at the same time it is mentioned that the synthetic biology organisms, products and components are regulated by a number of different sectorial regulations and divers types and instruments for risk assessment. The systems are diverging from country to country, even within the EU.

There is still no any consolidated opinion on the synthetic biology and a precaution approach for its safe use. I am of the opinion that many of developing countries and the countries with economies in transition have critically need to develop special rules and instruments in this regard, useful to prevent possible risks from its use, trade, transboundary  movements.  There were shared various concerns related the synthetic biology, as replication, bioweapon, pharmaceuticals, non-transparent trade etc. that can provide a considerable impact to the environment and human health and also have social and economic effects.

I am not of the opinion that the regulation of the Synbio should involve as well the positive economic assessment of such organisms/products as this is not the scope of international or national rules to prevent possible damage or risks.   The risks of such organisms/products to biodiversity loss have not still been covered by any of international rules, so we consider important to develop special rules and procedures with regard of this aspect.

Besr regards,
Angela Lozan
Moldova
posted on 2015-07-02 10:46 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7358]
Dear all, 

Thanks for participating in this interesting discussion, which reflects quite some divergent views. My name is Boet Glandorf and I work as a senior risk assessor at the GMO Office in the Netherlands.

The questions posed are:
1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?
2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

As indicated in the report CBD Technical Series no. 82 ‘the tools of synthetic biology represent an expanding frontier of biotechnology, but current applications can be considered to remain within the Cartagena Protocol’s definition of modern biotechnology’. I agree with this statement. As long as organisms obtained by synthetic biology are captured by this definition of the Cartagen Protocol, instruments are in place that regulate the transboundary movement, transit and handling and use of these organisms. In addition, there is an adequate framework available to assess potential risk of these of these organisms to biodiversity and human health. Components and products of these organisms are captured by existing product regulations, including those for LMOs/GMOs.

As indicated also by other participants on this forum,  there is no need to develop new protocols or legislation for organisms of synthetic biology, since we already an adequate system in place for LMOs. This system is also applicable for organisms obtained by synthetic biology (for now and the near future). However, developments go fast and we have to keep track of those developments. Depending on how things will develop, this may lead to adaptations to the existing regulations and the existing risk assessment framework for LMOs.

Kind regards,
Boet Glandorf
posted on 2015-07-02 12:16 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7359]
Dear collegues,
My name is Katsiaryna Sidarenka and I represent the National Co-ordination Biosafety Centre (NCBC) of Belarus.
In Belarus we do not have specific laws for organisms and products obtained using Synthetic Biology. At the moment we are using laws based on Cartagena Protocol on Biosafety. However we think that specific regulation of Synthetic Biology may be extremely useful especially when thinking about possible unpredictability of SynBio products and organisms.
posted on 2015-07-02 12:52 UTC by Ms. Katsiaryna Sidarenka, Institute of Genetics and Cytology at the National Academy of Sciences of Belarus
This is a reply to 7341 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7360]
Dear All,

I am Edward Hammond, Advisor to Third Word Network.  In reference to existing arrangements, I will offer a diverging opinion on the adequacy of measures taken in the United States.  My comments are made on the basis of fifteen years of research on safety oversight in US labs, including three national surveys to assess the functioning of local safety committees charged with overseeing synthetic biology research.  I have also recently participated in discussions at the governmental Office of Science and Technology Policy (OSTP) on lab oversight matters.

The United States is not a CBD Party but is a major county for synthetic biology research. In the US, laboratory safety arrangements for synthetic biology do not have the force of law.  They are, in essence, voluntary.

Even in cases where national rules, in theory, mandatorily apply to synthetic biology research labs (those that are publicly-funded), there is little to no actual oversight, and peer reviewed research has shown that noncompliance is a serious problem (see: Biosecur Bioterror. 2008 Mar; 6(1):19-35).

For example, the US Department of Agriculture has admitted that it frequently does not actually collect the "research assurance statements" that bind laboratories it funds to obey synthetic biology research rules. (Rules which the Agriculture Department also does not administer.)

Even more worrying, this voluntary safety oversight system almost entirely misses the private sector, which does not register its research safety committees with the government and operates labs essentially beyond rDNA and synthetic biology safety oversight.

Indeed, the Government Accountability Office (GAO), the investigative office of the US Congress, has investigated laboratory safety in recent years and has repeatedly concluded that nobody in the US government actually even knows the location of all the rDNA and synthetic biology facilities, and has repeatedly recommended that legislation be adopted to improved and centralize oversight.

One part of the problem is that this voluntary system is housed in the policy department of the US National Institutes of Health which, while having obvious expertise in biomedical research, is not well-versed or institutionally focused on other synthetic biology applications, for example, in agriculture and manufacturing. Yet a very small office at the US health ministry is (theoretically) overseeing safety of the latter types of experiments.

To wit, as part of a national survey of safety practices that I conducted in 2014, it was discovered that a large scale and publicly funded biomanufacturing institute (Michigan Biotechnology Institute) was in complete noncompliance with federal rules. The Institute did not even have a safety committee. Michigan Biotechnology Institutes noncompliance was so severe that the Institute wasn't aware of federal safety rules that applied to it and denied, repeatedly and in writing, that it needed to have a safety committee at all. It was only by NGO investigation that this problem was identified and the institution later sanctioned. Notably, this institute operates a number of very large fermentors in which it uses rDNA organisms and has many of the same key characteristics as would be used in many types of synthetic biology manufacturing.

There are other serious and interlocked problems in oversight of synthetic biology research in the US. In particular, there is insufficient oversight of individual scientists, particularly with respect to the projects that they choose to perform, leading to a situation where individual researchers inappropriately judge the safety of their own studies. Synthetic biologists may lack the knowledge and inclination to properly assess the potential impact of their research, including the impact of both intended results and incidental ones and accidents, on biodiversity and human health. And as facilities conducting synthetic biology research are, in general, not legally overseen per se, neither facilities nor researchers are required to obtain a license.

Possession of a very small number of particularly dangerous organisms, including a number of microorganisms that may be generated by synthetic biology techniques (e.g. Ebola, pandemic influenza), is covered is the United States by a binding licensing regime, however, the US methodology of maintaining a list a specific organisms, possession of which triggers the rule, is poorly adapted to and cannot be effective applied to synthetic biology.  This is because creation and possession of synthetic organisms incorporating even quite small nucleic acid changes from the natural type fall outside the scope of activities covered by the licensing regime, even if the synthetic pathogens maintain (or even worsen) the potential effects on biodiversity and human health of their unmodified analogs, another major (and dangerous) loophole in the the existing arrangements.

Thank you for the opportunity to make these comments.

Edward Hammond
posted on 2015-07-02 13:14 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7363]
Topic 6:  Adequacy of existing instruments to regulate organisms, components or products derived from synthetic biology.

I thank the Secretariat and Moderator for this final round of discussion.  We in this discussion group have a profound responsibility and opportunity. 

Judging from what I have read from this group so far, my views will be in the minority.  Nevertheless, as one trained and practiced in population issues rather in laboratory research, I hope my contribution will prove useful.  I appreciate the UN Environmental Program policy on recognizing diverging viewpoints (16 May 2014 UNEP Proposed Procedures...IV G).  This policy should lead to a healthy, robust report.

Regarding the Moderator’s first question (Which instruments exist?), CBD Tech. Series 82, Part II summarizes the instruments well [with the addition of the 1925 Geneva Protocol as pointed out by Regalado (#7321)].  As noted in CBD TS 82, p. 68, since synthetic biology itself has not been addressed by the treaties noted and since this discussion has often found synthetic biology to be a “step change” in biotechnology, systematic rules should be formulated as soon as possible to guide the appropriate development of this field.  Christopher Then in #7221 offers substantial justification for rule-based regulation.  So does the dictionary definition of “regulate” — control by means of rules and regulations.

Regarding the Moderator’s second question (“Are these instruments adequate to address…the objectives of the Convention and its Protocols?”), I say with confidence they are not adequate. 

The first-stated objective of the Convention is “the conservation of biodiversity.” 
Yet, the world continues to experience a profound loss of biodiversity (Living Planet Report 2014; WWF, Zool Soc London, Global Footprint Network, Water Footprint Network)—a 52% decrease in the Living Planet Index between1970 and 2010 (a 13% loss per decade). Yet existing international instruments to regulate biodiversity do not even provide for its monitoring. 

Moreover, the CBD defines biodiversity as including “diversity within species, between species and of ecosystems.”   Thus, counting the proportion of species lost without also assessing ecosystems does not adequately monitor biodiversity.  The last global assessment of ecosystems was the 2005 Millennium Ecosystem Assessment.  Thus, we lack the basic tools to frame how synthetic biology should be contributing to the first objective of the CBD!  CBD instruments need to correct this.

The overall task of this Discussion Group is not, ‘How to make the world safe for synthetic biology?” but “How to make synthetic biology safe for the world?”  Existing
instruments that now apply to synthetic biology address the direct and most likely risks.
As noted in CBD Tech. Series 82 (p 38), “there has been a tendency among
governments to respond to synthetic biology as if it represents only identifiable and
measurable risks.”  Where is the provision for direct risks not yet identified by those engaged in this very young technology?

Indirect risks may be even more important than direct ones.  Not only have humans consumed unsustainable proportions of nature, we have also polluted the air, land and waters of the earth.  Schwågerl notes in The Anthropocene (Synergetic Press; 2014; p. 132):
  ...A large proportion of what we refer to as “environmental problems” these days—climate change, electronic scrap, plastic pollution—derives from the fact that the technosphere is terrible at preventing waste and recycling its components in the way that leaves do when they fall from trees…
Schwågerl continues (p. 140):
  ...Future technology has to consist of machines, materials and molecules that adapt to the biologic cycles of earth instead of perturbing them, and they have to enrich earth with life-enhancing stimuli instead of discharging poisons.

Do the existing CBD regulations for living organisms address risks yet unrecognized?  Do these regulations address the potential indirect effects of synthetic biology?  The answer is No to both questions.

Further, in regard to synthetic biology, Schwågerl notes (p. 164-5):
  ...Without consensus on the aims and limits of cultivating synthetic life, this field will soon simply reflect the ambitions of individual scientists or the profit-hunting instinct of large companies…
  ...The danger that artificial life could escape from laboratories in the process of synthetic biology is just one aspect of the problem.  The greater danger is that scientists change fundamental attitudes to life for the worse:  an industrial biology that produces animals as if they were flat-screen TVs…and treats living creatures as mere “technology platforms,”…
  ...[Synthetic biology]…represents one of the most sensitive research projects of all time, and the entry into a new dimension of life and human power…
  ...An even harder question in this respect and one that affects people directly is:  who is in control?  How should a society that uses nature as mere biomass and raw material deal responsibly with the knowledge of how to synthesize life?...
  …The eugenic crimes of the twentieth century are a strong warning of just how wrong developments can go.

Our species has conducted what amounts to a long, protracted war on nature.  The situation is so dire that it has called forth an encyclical from Pope Francis, who says:

  ...This sister (“Mother Earth”) now cries out to us because of the harm we have inflicted on her by our irresponsible use and abuse of the goods with which God has endowed her. We have come to see ourselves as her lords and masters, entitled to plunder her at will.   (2nd section)
  …The earth, our home, is beginning to look more and more like an immense pile of filth.  (21st section)
  …It is essential to seek comprehensive solutions which consider the interactions within natural systems themselves and with social systems. We are faced not with two separate crises, one environmental and the other social, but rather with one complex crisis which is both social and environmental.  (139th section)
  …Where profits alone count, there can be no thinking about the rhythms of nature, its phases of decay and regeneration, or the complexity of ecosystems which may be gravely upset by human intervention. Moreover, biodiversity is considered at most a deposit of economic resources available for exploitation, with no serious thought for the real value of things, their significance for persons and cultures, or the concerns and needs of the poor. (190th section)
  …The Earth Charter asked us to leave behind a period of self-destruction and make a new start, but we have not as yet developed a universal awareness needed to achieve this. Here, I would echo that courageous challenge: “As never before in history, common destiny beckons us to seek a new beginning… Let ours be a time remembered for the awakening of a new reverence for life, the firm resolve to achieve sustainability, the quickening of the struggle for justice and peace, and the joyful celebration of life”. (207th section)

The words above, taken from Pope Francis’s Encyclical, reflect to me, a Quaker of Jewish background, the social, ethical and moral perspective that should be reflected in the Convention on Biodiversity’s instruments to regulate synthetic biology.  We need such regulations to fulfill the Convention’s primary objective—the conservation of biological diversity.
posted on 2015-07-02 20:08 UTC by Dr Frederic Bass, self-employed
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7364]
Dear all,
My name is Deborah Scott, and I am a social scientist studying the governance of emerging technologies. My recent PhD dissertation examines the CBD’s engagement with synthetic biology, and I’ll soon start a post-doc research position at the University of Edinburgh’s Science, Technology and Innovation Studies, from which I hope to continue to follow CBD processes.

I believe social science scholarship can help contextualize many of this forum’s discussions, including the question of the adequacy of existing regulatory instruments. The Nuffield Council on Bioethics (2012) identifies three challenges of emerging biotechnologies such as synthetic biology: 1) uncertainty (lack of knowledge about the range of potential outcomes and probability that any particular outcome will occur); 2) ambiguity (lack of agreement about the implications, meanings or relative importance of a given range of possible outcomes); and 3) transformative potential (capacity of an emerging biotechnology to transform or displace existing social relations, practices and modes of production).  The diversity of perspectives in this forum could be seen in part as expressions of different approaches to these three challenges. 

Excellent research has been done to better understand and grapple with these challenges. David Guston & Daniel Sarewitz at Arizona State University have been developing the concepts of “real-time technology assessment” and, more broadly, “anticipatory governance” as ways to respond to such challenges.  Andy Stirling at the University of Sussex has written extensively on the need for decision-making to “keep it complex” and not reduce more intractable uncertainties to “risk” alone. The 2007 report of the European Commission’s Expert Group on Science and Governance, “Taking European Knowledge Society Seriously”, includes practical recommendations for science & policy, including ways that precautionary policies can address a fuller range of types of uncertainties.

And a lot of research and insightful analysis has already been done on synthetic biology in particular. I’ve included just a few citations below that are publicly available (not behind pay-walls), and would be happy to supply more.  These resources could help situate the discussions of this online forum, from definitional debates to the challenges of identifying positive and negative impacts, and may help the AHTEG in considering its goals, processes, and potential outputs.

SYNTHETIC BIOLOGY - SPECIFIC REFERENCES:
Arnim Wiek, David Guston, Emma Frow & Jane Calvert. 2012. Sustainability and anticipatory governance in synthetic biology. International Journal of Social Ecology and Sustainable Development 3(2): 25-38.  http://cspo.org/legacy/library/1301221157F60409977IV_lib_WiekSustainabili.pdf – Traces how sustainability has been addressed in synthetic biology reports, and suggests an approach for meaningfully and systematically incorporating sustainability considerations into the development of synthetic biology.

Catherine Jefferson, Filippa Lentzos, & Claire Marris. 2014. Synthetic Biology and Biosecurity: Challenging the “Myths”. Frontiers in Public Health 2: 115. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139924/   - On the importance of grounding discussion on synthetic biology’s potential impacts in the current realities of the field.

Joy Y. Zhang, Claire Marris & Nikolas Rose. 2011. BIOS Working Paper No. 4: The Transnational Governance of Synthetic Biology: Scientific uncertainty, cross-borderness and the 'art' of governance. http://www.kcl.ac.uk/sspp/departments/sshm/people/academic/marris/TransnationalGovernanceSynBio2011.pdf  – Proposing a governance approach that is flexible, able to work with uncertainty and change.

GENERAL REFERENCES:

Nuffield Council on Bioethics. 2012. Emerging biotechnologies: technology, choice and the public good. London: Nuffield Council on Bioethics. Available at: http://nuffieldbioethics.org/project/emerging-biotechnologies/

David H. Guston & Daniel Sarewitz. 2002. Real-time technology assessment. Technology in Society 24: 93-109. Available at: http://archive.cspo.org/documents/realtimeTA.pdf

Andy Stirling. 2010. Keep it complex. Nature 468: 1029-1031. Available at: http://www.researchgate.net/profile/Andy_Stirling/publication/49703137_Keep_it_complex/links/0a85e53106cefb82e6000000.pdf

Ulrike Felt (rapporteur) & Brian Wynne (chairperson). 2007. Taking European knowledge society seriously: report of the Expert Group on Science and Governance to the Science, Economy and Society Directorate, Directorate-General for Research, European Commission. Luxembourg: Office for Official Publications of the European Communities. Available at: http://www.synbioproject.org/process/assets/files/6452/_draft/european-knowledge-society_en.pdf
posted on 2015-07-03 00:00 UTC by Ms. Deborah Scott, University of Edinburgh
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7365]
I am Bob Friedman. 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 appreciate the opportunity to participate in and learn from this on-line forum.

I would like to highlight and strongly support a suggestion by Paul Freemont (#7333): that “it will be extremely helpful if all of the existing regulatory frameworks were openly shared and discussed in relation to synthetic biology, with best practices and gaps identified.”

Representatives from quite a few countries have offered citations and descriptions of national programs to augment the discussion of international programs discussed in CBD Technical Series no. 82.  I will add a recent report by my organization that evaluates how well the current U.S. biotechnology regulatory system is equipped to handle the anticipated products engineered using synthetic biology.  http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-system/overview/

This augments contributions from Cuba (#7231), New Zealand (#7324), Brazil (#7332), Canada (#7338), US (#7341 and #7345 under topic 7), EU (#7349) and UK (#7351).  We have also heard from Moldova (#7328) and Belarus (#7359) that perhaps their regulatory systems are not adequate.

Our research concluded the U.S. system is adequate to address most environmental, health, and safety concerns posed by anticipated near term products engineered using synthetic biology.  However, we also identified several challenges to the current U.S. regulatory system, which now identified, can be addressed.

To my way of thinking, this is an important task for each country to undertake.  The U.S. Government recently announced that it will begin its own such review “to ensure that the system is prepared for the future products of biotechnology”.  https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring-continued-safety-biotechnology.  Such periodic reviews are the only way to ensure that our national regulatory systems keep pace with technology, and at the same time, allow society to continue to benefit.
posted on 2015-07-03 00:52 UTC by Mr. Robert Friedman, J. Craig Venter Institute
This is a reply to 7358 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7366]
Dear All participants,

I am Hideyuki Shirae working in Japan Bioindustry Association which is a non-profit organization and we are engaging in promoting biotechnology and also conducting the spread of Cartagena Protocol to Japanese industries.

There are two questions in Topic 6 as follows;
1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?
2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

Regarding the two questions submitted from CBD secretariat, I completely agree with Ms. Boet Glandorf’s comments[#7358], and it had better discussing separately, organisms and components/products derived from synthetic biology because there does not seem to be common understanding between participants in this forum about what the “component” and “Products” derived from synthetic biology are.

As I mentioned before, most of participants have the same opinion that the ”organisms” derived from synthetic biology must be “LMO” under the Cartagena Protocol.  Therefore, it will be important to coordinate this issue with RM AHTEG under Cartagena Protocol.  That is true.

In the final report of COP-MOP7 (UNEP/CBD/BS/COP-MOP/7/16), the following article exists;
“17. Recommends to the Conference of the Parties to the Convention on Biological Diversity a coordinated approach with the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety on the issue of synthetic biology, taking into account that the provisions of the Protocol may also apply to living organisms resulting from synthetic biology.(in BS-VII/12.Risk assessment and risk management (Articles 15 and 16))”

I would like to advise to all that first the discussion must be needed about whether the existing regulation under Cartagena Protocol is sufficient to cover the organisms (LMO) derived from synthetic biology or not now and in future, in RM AHTEG of COP-MOP(Cartagena Protocol).

Regarding the two items, “Components” and “Products”, their unified scopes/definitions are necessary to go forward this discussion.

Hideyuki
posted on 2015-07-03 01:41 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 7365 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7368]
POSTED ON BEHALF OF HIROSHI YOSHIKURA

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I was Chair of the Codex Alimentarius Task Force on Foods Derived from Modern Biotechnology and a bureau member of OECD Working Party on Biotechnology. Mr. Robert Friedman’s posting (#7365) referring to Paul Freemont’s comment (#7333) [“it will be extremely helpful if all of the existing regulatory frameworks were openly shared and discussed in relation to synthetic biology, ……”] reminded me of the time when “biosecurity issue” was brought in OECD. The biosecurity issue is complex one because it concerns security of dangerous pathogens, shipping of pathogens for prompt laboratory diagnosis, property right of the pathogens of the countries of origin, innovation, academic freedom, etc. which are often mutually conflicting. The secretariat OECD provided a portal that compiles the member countries’ laws, regulations, guidelines, notices, etc. related to the biosecurity. Though biosecurity issue is still debated, the approach taken by OECD prevented us from making too hasty decision and allowed us more precautionary approach to this issue. It may be an interest for CBD to take a similar approach, i.e., to have a portal of national regulations that could be applied to synthetic biology, because the current forum’s opinions appears divided between “we have” and “we don’t have”. In my view, what is most important is how the country applies regulations. For example, if I am correct, USA applied the existent laws to GMOs, while many other countries made a new GMO law. Both approaches appear working.

Sincerely,
Hiroshi Yoshikura
posted on 2015-07-03 15:32 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7371]
Dear Benson, 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.

I would like to thank the organizer again for this discussion platform, which has - by the diversity of views - very well reflected the multilayer status of synthetic biology and its potential implications. Thus I agree with the analysis of Deborah Scott (#7364) that the evaluation of the discussion has to take into account the uncertainty (lack of knowledge); ambiguity (lack of agreement, political context); and the transformative potential synthetic biology. With respect to the adequacy of existing national, regional and/or international instruments for the regulation, I would like to add one more aspect that needs to be taken into account to differentiate the discussion. That is the time point of development, we are discussing on:

- For current developments in synthetic biology the regulatory framework for example in the EU (#7351), and the US (#7340), is being discussed as sufficient and I would agree on that. However I would be cautious on the statement that all instruments are fully adequate (#7340) leaving out socioeconomic impacts that was rightly being asked for (#7331). Also it has been pointed out that the current legal framework has its pitfalls (#7341).

-#7334 and #7352 point to future applications and I agree with #7349 that we need to assess at what point our current instruments are no longer fully adequate. This will especially be the case when the principle of familiarity cannot be applied for the risk assessment procedure anymore.

One solution to this could be the development of instruments of monitoring to ensure that the regulatory systems keeps pace with technology, as being suggested earlier (#7349, #7365). In this context I see the suggestion of Paul Freemont (#7333, supported by #7365) to openly share and discuss existing regulatory frameworks and to discuss best practice and gaps as a very helpful instrument.

In summary I would like to promote for a nuanced terminology that reflects the complexity of the field.

With best regards,
Margret
posted on 2015-07-03 16:38 UTC by Ms. Margret Engelhard, Germany
This is a reply to 7333 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7372]
POSTED ON BEHALF OF ZABTA SHINWARI

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Dear All participants,

I am Zabta Shinwari working as Professor and Chairman of Biotechnology, Qauid-i-Azam University and alsoSecretary General of Pak. Academy f and we are not only teaching biotechnology especially biosafety and biosecurity but also raise awareness regarding synthetic biology. 

From Pakistani side let me reinforce that  the current Pakistani biotechnology regulatory system is not equipped to handle the anticipated products engineered using synthetic biology.

I support a suggestion by Paul Freemont (#7333): that “it will be extremely helpful if all of the existing regulatory frameworks were openly shared and discussed in relation to synthetic biology, with best practices and gaps identified.”

Regarding two questions in Topic 6:

1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?

2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

I completely agree with earlier comments, and it had better discuss separately, organisms and components/products derived from synthetic biology because there does not seem to be common understanding between participants in this forum about what the “component” and “Products” derived from synthetic biology are.


In the final report of COP-MOP7 (UNEP/CBD/BS/COP-MOP/7/16), lets read the article:
“17. Recommends to the Conference of the Parties to the Convention on Biological Diversity a coordinated approach with the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety on the issue of synthetic biology, taking into account that the provisions of the Protocol may also apply to living organisms resulting from synthetic biology.(in BS-VII/12.Risk assessment and risk management (Articles 15 and 16))”

Lets focus whether the existing regulation under Cartagena Protocol is sufficient to cover the organisms (LMO) derived from synthetic biology or not

I appreciate the UN Environmental Program policy on recognizing diverging viewpoints (16 May 2014 UNEP Proposed Procedures...IV G).  This policy should lead to a healthy, robust report.

Zabta
posted on 2015-07-03 17:02 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7373]
This contribution was duplicated and deleted.
(edited on 2015-07-03 20:05 UTC by Ms. Manoela Miranda)
posted on 2015-07-03 17:11 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 7373 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7376]
Dear All,

I thank the Secretariat and the moderator for this space where we can express and know the different views on the issues raised around synthetic biology.

On the questions, I agree with some interventions on the existent national, regional and international instruments are not sufficient to cover all types of organisms, product components from synthetic biology(## 7353, 7352, 7348, 7348).

So must the ATEGH on Synthetic Biology should provide clarity on definition of synthetic biology because this is a broader category that LMOs as defined under the Cartagena Protocol, the Codex Allimentarius and / or other international agreements. [#7357] Under this framework, there is an urgent need for adequate regulation at the national, regional and international levels that includes the specific impact on biodiversity conservation and sustainable use of biological resources. It is necessary to develop a new agreement (protocol) should be discussed within the CBD / CPB with guidance for this specific topic.

Moreover, this specific international framework must contain and useful instruments to avoid possible risk of their transboundary movements, use, trade. There are various shared concerns expressed related to synthetic biology, such as replication, bioweapon, pharmaceuticals, non-transparent trade, etc., that can provide a considerable impact to the environment, human health, cultural, socio-economic effect.

Best regards,  

Sorka Copa Romero
Bolivia (Plurinational of State)
posted on 2015-07-03 22:47 UTC by Ms. Sorka Jannet Copa Romero, Bolivia (Plurinational State of)
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7378]
Dear forum participants,

I’m Dr. Louise Horsfall (University of Edinburgh), and with my colleague Patrick Rudelsheim,we have been selected to represent the European Federation of Biotechnology (EFB - http://www.efb-central.org) and its 30,000+ members.

1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?
2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

The UK and EU perspectives have been outlined very well in previous post (#7351) and I am pleased that the UK Health and Safety Executive is so helpful in its approach to synthetic biology researchers and innovators. The EU regulatory framework is equally as adequate but rather less responsive.
Sharing of best practice (#7333) to both better support the activities of those researching and innovating within the regulations and to prevent the activities of those practicing outwith would be helpful.
Members at recent EFB meetings agreed that the EU regulatory framework is adequate and fit for purpose in managing risk to human health and the environment. After all, the approach that has been developed was intended to cover a wide range of applications, organisms and traits. The risk assessment process is based on principles that are universally applicable to virtually any risk area and therefore doesn’t require adaptation per se. The concerns raised in the discussions thus far appear to focus on (often hypothetical) activities that would be against current EU regulations, which would also suggest that the framework is sufficient.
We have to remember in these discussions that synthetic biology is an underpinning technology and therefore it is the resultant innovations that need to be assessed and correctly regulated. Otherwise alternative techniques, not ascribed to synthetic biology, may be employed to meet the same outcomes. Also, we cannot use currently decreasing biodiversity (#7362) as justification that current rules governing synthetic biology are inadequate, this would suggest that the Convention and its protocols are failing elsewhere as synthetic biology is still a new and emergent area, full of unrealized potential.

Many thanks,
Louise and Patrick
posted on 2015-07-04 16:55 UTC by Dr Louise Horsfall, University of Edinburgh
This is a reply to 7376 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7379]
Topic 6:  Adequacy of existing instruments to regulate organisms, components or products derived from synthetic biology.

I thank the Secretariat and Moderator for this final round of discussion.  It is important to hear different points of view and to take the time to discern a responsible way forward.  We need to figure out a way forward that is wholistic and sees nature as crucial to the continued existence of species that live on Earth - our home.   The future of our children, our grandchildren, other species, our health and the environment is at stake.   Do the processes and products of this technology contribute to the wellbeing of future generations or is economic gain the only outcome that is considered?    What are the environmental, social and ethical consequences?    And who is making the decisions? 

Regarding the question Which instruments exist? – these are summarized well in the CBD Tech. Series 82.  As noted in CBD TS 82, p. 68, since synthetic biology itself has not been addressed by the treaties noted and since this discussion has often found synthetic biology to be a “step change” in biotechnology, systematic rules should be formulated as soon as possible to guide the appropriate development of this field. 

The conservation of biodiversity is a priority of the CBD but we continue to experience loss of biodiversity.  We need to strengthen international regulations and monitoring systems to reduce the impact of economic interests on biodiversity.  We do not know what future risks there might be with synthetic biology and we do not have systems and processes in place to address any unexpected impact of this technology on biodiversity.   The precautionary principle has to be built in.

Anne Mitchell
posted on 2015-07-04 19:16 UTC by Ms. Anne Mitchell, Retired
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7380]
My name is Gerd Winter. I am a professor of environmental law at the university of Bremen, Germany
As topics 6 and 7 are closely related I take the freedom to discuss them together.
I agree with many contributors to this discussion that there is a need to study more closely the different existing regulatory regimes on biotechnology processes and products, focussing on whether they cover risky strands of SynBio , and how they should be adapted or – where no regulation exists – might be created. This cannot be done by an online-forum but would need through research.
As many have done before I suggest to raise the following questions.
(1) Does the Cartagena Protocol adequately deal with SynBio? I believe it does not.
a) It’s scope of application – products from modern biotechnology - leaves out certain strands of SynBio products. Which ones would have to be found out by closer examination.
b) It concentrates on products and appears not to cover bioparts that may cause risks if traded without any restriction.
c) It’s focus is on transnational shipment of products, obliging export countries to care for import country concerns and allowing import countries to establish their own risk regulation. It does not strive for establishing a minimum standard of risk regulation within contracting states, neither for GMOs in the traditional sense nor for modern SynBio.
d) The Protocol does not deal with the digital transboundary movement of BioTech-Products. The prior information duties might also have to be attached to digital transfers (a question, by the way, which is also crucial and complicated in relation to access to genetic resources and benefit sharing).
e) The risk assessment methodology outlined in Annex III of the Protocol is much too general to cope with the varieties of risk of SynBio.
(2) Do we need a new Protocol on risks of biotechnology? I believe: we do.
a) As a result of the above analysis it appears that a new initiative is needed that aims at improving national regulatory systems and coping with transnational risks that are not caused by trade but by natural spread of organisms (see Christoph Then # 7287).
b) The initiative might be based on Art. 8 g) CBD as suggested by Jim Thomas (#7375). As human health is also affected, the WHO and FAO should also be involved. I believe the definition of biotechnology of the CBD (Art. 2: "Biotechnology" means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use) is broad enough to cover all kinds of processes and products in need of regulation.
c) I believe that the new approach should address “biotechnology” in this broad sense rather than “genetic engineering” or “synthetic biology”, because the definition of genetic engineering is outdated and that of SynBio highly arbitrary. What is needed is to put together a list of potentially dangerous products and activities of biotechnology, and develop a regulatory regime fitting to them.
d) The new Protocol could be a self-standing one or consist of a thorough revision of the Cartagena Protocol. In the latter case the scope of application of the Protocol would have to be extended to more kinds of biotechnology than just those called “modern”. A long chapter would have to be added on standards for national regulation and an international mechanism in charge of transnational spread of dangers.
(3) What can be learned from national regulatory systems for the design of the new Protocol? I believe: a lot.
a) Notorious is the difference between the product related approach adopted by the US, Canada, New Zealand and others , and the process related approach taken by the EU and others. Arguments have been exchanged on the advantages and drawbacks. The EU arguments are these: (1) Some novel products of SynBio will not be captured by the existing product related laws.(2) Some of the laws do not require prior authorisation, not even prior notification, but only establish rights of authorities to intervene (4) The chemicals legislation does not really capture dangerous  bioparts because prior notification duties presuppose high production volumes that will hardly be reached (4) in order to assess risks of products process related knowledge is anyway necessary. Nevertheless, it will probably be illusionary to expect that an International Protocol can bridge the gap (see the optimistic statements by Genya Dana on US, # 7341, Jim Louter on CDN, #7338.) Therefore, both systems should be accepted but internally improved to provide the same level of protection.
b) Equally notorious is the problem of comparative study and familiarity in the risk assessment of GMOs. While it is already controversial if a modified organism can validly be compared with its “natural” counterpart such comparison becomes all the more unfit the more artifical the SynBio organism is because a “natural” counterpart may be missing.
c) National systems have a certain experience with designing instruments of control. For instance, some problematic processes and products should be subject to prior authorisation, while for others a prior information may be sufficient.
d) Very important will be access of the public to relevant information, the participation of the public in authorisation and prior information procedures, and access to courts by affected parties and associations.
e) I am not sure if socio-economic effects should be part of the regulatory regime. They are in some countries but have seldomly played a practical role. The question needs further discussion. Maybe we can learn more about it considering the new EU Directive 2015/412 which allows EU Member States to opt out of the authorisation of gm seeds and restrict their cultivation for reasons of agricultural policy, socio-economic effects and ethical considerations.
Best regards
Gerd Winter
posted on 2015-07-04 19:22 UTC by Mr. Gerd Winter, University of Bremen
This is a reply to 7380 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7382]
Dear all,

I would like to thank once again the opportunity for all the participants to discuss the issue of synthetic biology within the scope of the CBD and under the BCH open-ended online fora portal.

1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?

In Brazil, synthetic biology is not covered by a specific law. The Brazilian Biosafety Law 11.105/2005 covers LMOs issues in accordance to the CP.  However, I echo previous statements that have pointed out that organisms, components and products of synthetic biology techniques make up a broader category than LMOs as defined under CP and so there is an urgent need for their adequate regulation at national, regional and international levels.

2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

The general principles of the risk assessment framework provided in Annex III of the CP are adequate to address the potential impacts of synbio organisms and products.

However, I also echo previous posts that have pointed to gaps that not all the SynBio products and organisms might be covered by the existent documents, as well as to the specific impacts to the biodiversity conservation and sustainable use and that these have not been considered at the international and national levels. Although not all kinds of synbio organisms and products are already in the market, I encourage the exercise and the discussion for the anticipation of their regulation in pursuance of safe use of these technologies.

Finally, I again echo those who have said that it would be extremely helpful if all of existing regulatory frameworks were openly shared and discussed in relation to synthetic biology with best practice and gaps identified. I also agree with others who suggested that a synergy in the work of the proposed AHTEG on Synthetic Biology and the existing AHTEG on Risk Assessment set up under the Cartagena Protocol, in regard to the topic of synthetic biology.

Best regards,

Sarah Agapito
posted on 2015-07-04 23:59 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7385]
Dear participants, I am Ana Atanassova from Bayer CropScience, and also representing Crop Life International. I appreciate the opportunity to contribute to the debate of the forum.

The CBD and the Cartagena Protocol provide the basic framework for assessing the potential impact on biological diversity of living modified organisms created through synthetic biology approaches. The standards and guidance of  international organisations such as the Codex Alimentarius Commission, OECD, FAO, and WHO also provide adequate guidance. Self-regulation by those working in the industry also plays an important role, with voluntary codes of conduct such as the Code of Conduct for Best Practices in Gene Synthesis of the International Association Synthetic Biology promoting responsible use of biotechnologies, biorisk management systems (e.g. CWA 15793:2011) and adherence to applicable laws and regulations.

Some of the comments posted under topic 6 point to the fact that different countries are at a different stage of implementation of the Cartagena Protocol. Such national gaps can be addressed by using the international guidance and best practices developed elsewhere, with many countries providing good examples of comprehensive regulatory regimes which also establish protection goals. As synthetic biology approaches result in the generation of living modified organisms, a new regulatory framework that only addresses a specific sub-category of use of “modern biotechnology” as defined under the Protocol  is not needed. Such a restricted framework will not replace the broadly applicable Protocol, nor overcome gaps in the implementation of the Protocol at the national level. In addition, it should be recognised that when products of synthetic biology approaches are not living organisms, alternative existing product regulations are applicable (for instance chemical or pharmaceutical substances) that will address any potential risks to human health and the environment.
posted on 2015-07-05 13:50 UTC by Ms. Ana Atanassova, Bayer CropScience
This is a reply to 7385 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7387]
Thank you to our moderator for this part of the discussion. I am Elpidio Peria, once agein, from the Philippines’ Biodiversity Management Bureau, a regulator.  My answer to the questions posed:

1) Which national, regional and international instruments exist that regulate the organisms, components or products derived from synthetic biology techniques?

In the Philippines, synthetic biology, as such technology  and all its variations and applications as discussed here in this online forum for the past several weeks now, is something that is not yet subjected to any regulation. To the extent that some techniques of synbio are similar to that used in LMO, then they may be covered by the existing National Biosafety Framework under Executive Order 514, (http://www.unep.org/biosafety/files/PHNBFrep.pdf) , though such kind of situation is something that has not yet been considered formally by the National Committee on Biosafety of the Philippines in a manner where it was discussed by all relevant agencies  with the mandate to regulate various aspects of the technology.

It may be useful to take a cue from the CBD Technical Report No. 82 which stated in its conclusion  in page 113, that  “there exist a range of uncertainties of their application in the absence of specific guidance” and while there may be frameworks  that may be applicable, such as the one developed for LMOs under the Cartagena Protocol, “ they may not be able to address the scope of the risks associated with some forms of synthetic biology techniques”. Even the potential impacts of synbio techniques according to the same report “might violate particular rules, but this cannot be determined unless there is greater confidence in estimates of such potential impacts.”.

All these concluding points in the discussion of the CBD Technical Report No. 82 indicate the uncertainties and the need for a consideration  of the precautionary principle on these matters.

One operational regulation on the precautionary principle is the Philippine Supreme Court’s  2010 Rules of Procedure on Environmental Cases (see annotation of this Rule on http://philja.judiciary.gov.ph/assets/files/pdf/learning_materials/A.m.No.09-6-8- SC_annotation.pdf, accessed 5 July 2015; goto page 61 for the annotation on Rule 20, the precautionary principle), though this is , more a guidance for litigants and their lawyers and the judges to decide on cases which involve the application of such rules.

As to regional instruments, like, at the level of the Association of Southeast Asian Nations (ASEAN) to which  the Philippines belongs, there appears to be no  framework that is currently  involving synthetic  biology or  even for biosafety.

As to international instruments, the discussion in Technical Report No. 82 appear to be a fair representation of the state of play in this area though if we look at the exchanges made, close attention needs to be given to the scenario pointed out by Christoph Then (#7334) and Edward Hammond (#7360), which completely contradicts the description  of the seemingly well-cooordinated existing US regulatory framework as described by Genya Dana (7341).  Matthew Legge’s (#7352)  observations on the previous interventions made also needs to be taken note of when evaluating the over-all weight and value of all the other  inputs given. The special needs of developing countries stated by Angela Lozan (#7357) in that “many of developing countries and the countries with economies in transition have critically need to develop special rules and instruments in this regard, useful to prevent possible risks from its use, trade, transboundary  movements” is something that will also have to be addressed by the Conference  of the Parties to the CBD eventually, but is an important dimension in these exchanges.


2) Are these instruments adequate to address the potential impacts on the objectives of the Convention and its Protocols?

What was stated by the Technical Report (no. 82) in its conclusion may be apt for this question when it said : “most regulatory mechanisms discussed in the present document were developed before the term synthetic biology became widely used and therefore they were not intended to cope with the scope and scale that some of the potential impacts of synthetic biology may have, including those with low and very low probability, but very high impacts.” Based  on this,  there needs to be a more thoroughgoing survey and analysis of the gaps on these frameworks in order that the objectives of the Convention will not be compromised.
posted on 2015-07-05 15:23 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7388]
Dear all
Just to be very concise. Existing international agreements although some of them may touch upon the issue of synthetic biology do not aim for the conservation and sustainable use of biological diversity and in this regards we believe that a guidance on the issue needs to be developed under the CBD.

Due to the evolving nature in this new field of science, most of the existing regulation are far from properly covering the issue of synthetic biology... many of the existing and expected products are or may be left out of the scope.

Normally when you are trying to develops new regime you conduct a stocktaking of what you already have in place. Thus we think that the Cartagena protocol with some amendments in the scope could appropriately cover the issue of synthetic biology.. no need to reinvent the wheel. I don’t want to repeat the discussion what was held under the previous forum so I will leave it here.
Regards,
O.A.El-Kawy
posted on 2015-07-05 17:29 UTC by Mr. Ossama AbdelKawy, Mauritania
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7393]
Dear Forum Participants,

I read carefully all of the participant’s important interventions. My name is Marina Rosales Benites de Franco from Peru.

The organisms, components or products derived from synthetic biology techniques are not regulate in Peru, especially which are derived from xenobiology (chemical synthetic biology).

It is a good news many that countries have development legislation on this matter. In this regard, it will improve if we review our capacities to do the risk assessment and the management of risk, taking account we need to enhance our knowledge to understand the risk that may have synthetic organisms or products, on the biodiversity and ecosystems. The developing countries and economic in transition will need more support for their capacity building.

In the other hand, there is not special international law to regulate transboundary movements of novel organism, components or products, which may have adverse effects on the conservation and sustainable use of biological diversity and human health.  It’s a challenge to create synergies with others international laws on transboundary movements on chemical products and others.

In the framework synthetic biology has positive and negative potential effects on biodiversity and ecosystems. It is very crucial to implement on this matter the paragraph 4 of decision XI/11, that urged Parties and invited other Governments to take a precautionary approach, in accordance with the preamble and with Article 14 of the Convention, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations.

Hence. I agree with many participants that it is necessary to consider a new international agreement, considering the above paragraphs and also that the Cartagena Protocol does not apply to the transboundary movement of LMO which are pharmaceuticals for humans.

Best regards,

Dr. Marina Rosales Benites de Franco
Professor Federico Villarreal National University
IUCN CEM Member: Commission on Ecosystem Management
(edited on 2015-07-05 18:08 UTC by Ms. Marina Rosales Benites de Franco)
posted on 2015-07-05 18:07 UTC by Ms. Marina Rosales Benites de Franco, IUCN
This is a reply to 7393 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7394]
I support the concept and implementation of an adaptive regulation approach of Synthetic Biology and am in agreement with Joyce Tait's publication "Adaptive Governance of Synthetic Biology" (EMBO Reports). Although a bit dated, I believe that the information presented in the article is still highly relevant to this discussion. The article states:

"Synthetic biology has the potential to revolutionize the development of drugs, vaccines, biofuels and food crops, and to clean up environmental pollution, but the field is relatively young."

"Reports from the US Presidential Commission for the Study of Bioethical Issues (PCSBI) and from the International Risk Governance Council (IRGC) [PCSBI (2010) New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Washington DC, USA: PCSBI; Lowrie H, Tait J (2011) Guidelines for Appropriate Risk Governance of Synthetic Biology, International Risk Governance Council Policy Brief.] have attempted to develop principles of good governance that could be applied to synthetic biology, given the uncertainty about the nature of future developments. The reports recommend that policy-makers should aim for a governance approach that can adapt to changing innovation opportunities emerging from new scientific discoveries; encourage and promote innovation; minimize risk to humans and the environment; and balance the interests and values of all relevant stakeholders."

"The governance of synthetic biology should achieve an equitable balance between promoting innovation and imposing constraints to ensure safety. Dialogue with stakeholders should be conducted in a manner that welcomes the respectful exchange of opposing views and encourages mutual accommodation of differing opinions. Dialogues should contribute to decisions being taken on the basis of the best available evidence. Considering potential dual-use risks of synthetic biology, both reports note that undue restriction might be counterproductive to safety and security, by preventing the development of effective safeguards against, for example, terrorist threats."

It is important to emphasize that the availability and quality of neutral, impartial scientific evidence used to support policy advice and decision-making is of the utmost importance for the development of an effective adaptive regulatory approach, rather than relying on evidence that suits the agendas of particular advocacy groups.

Kind regards,

Bruce
posted on 2015-07-05 19:36 UTC by Mr. Bruce Dannenberg, Phytonix Corporation
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7396]
My name is Dr. Todd Kuiken and I am the principle investigator of the Synthetic Biology Project at the Woodrow Wilson Center. I would like to thank the moderator for facilitating this round of discussions.  I will focus my submission around a forthcoming report that the Wilson Center will be releasing later this month which examines the adequacy of the U.S. regulatory system to evaluate the products and applications of synthetic biology. Our report examined how the U.S. Coordinated Framework could deal with five applications of synthetic biology: a bio-pesticide, glowing plants, squalane, a bio-mining application, and Oxitec Ltd. Mosquito. I will provide the full report to the AHTEG and the online forum once it has been finalized later this month. 
The case studies we examined showed that while some applications could escape any and all review others could trigger multiple laws/regulations within the same agency.  While we do not believe an new regulatory system is needed to address synthetic biology the general conclusion of our analysis is that the U.S. Coordinated Framework needs to be updated, periodically reviewed, and made adaptable in order to incorporate the products and applications of synthetic biology and to provide a transparent process for both companies and the public to understand how the process is conducted. 
Our report comes just as the U.S. Office of Science and Technology Policy issued a directive on July 3, 2015 to “modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system. The objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” I have attached the full memorandum from the White House.
I would also like to support the comments in part by Jim Thomas (#7375) in regards to the digital component of synthetic biology and to encourage the AHTEG to coordinate its review with the discussions happening within the Nagoya Protocol and possible interactions between the requirements of the Protocol and the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property (TRIPS).  The Wilson Center is currently finalizing a report which explores emerging concerns regarding “digital biopiracy” and presents highlights of negotiations in the World Intellectual Property Organization (WIPO) Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge, and Folklore (IGC), that may relate to both the Nagoya Protocol and TRIPS and thus may be relevant for the discussions within the CBD as it relates to synthetic biology. I will submit the report to both the AHTEG and the online forum once it is finalized.

I look forward to the continued discussion.

Todd Kuiken, Ph.D.
posted on 2015-07-05 20:23 UTC by Mr. Todd Kuiken, North Carolina State University
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7400]
Dear Forum Participants,

my name is Christian R. Boehm and I am Gates Cambridge Scholar at the University of Cambridge. Here I represent the European Association of Students and Postdocs in Synthetic Biology (EUSynBioS) which embraces several hundred young researchers active in the field from 15 different European countries. Thank you very much for this opportunity and the great contributions made so far.
The below comment is shaped by remarks from interested EUSynBioS Members, but primarily reflects the perspective of my colleague Devang Mehta and myself on this matter:

Synthetic biology is an extension of biotechnology, and is as such in principle appropriately regulated by existing frameworks related to the latter discipline. Many attempts have been made at drafting a definition of synthetic biology, and the majority of these attempts emphasize adoption of principles from design, engineering, and information technology to create or modify biological systems towards meeting a particular purpose.  What is novel about synthetic biology compared to biotechnology lies in its approach and principles rather than in its components or products (living or non-living). It also appears unclear why LMOs generated by means of synthetic biology intrinsically present novel challenges for containment compared to products of biotechnology. An attempt at specifically restricting components or products of synthetic biology would create serious challenges in differentiating synthetic biology from biotechnology, and would in many cases unnecessarily affect varied industries and research programs.

However, while a distinct regulatory framework for synthetic biology does not appear to be necessary, I strongly agree with the previous suggestion (#7333) that sharing and discussing existing national regulatory frameworks to identify gaps would be highly desirable. Its compounds and products may be indistinguishable from those derived by biotechnology, yet the synthetic biology approach has simplified and accelerated the generation of modified and synthetic biological systems compared to what would have been possible based on more traditional biotechnology techniques alone. As it has been previously stated several times, it will likely be impossible to predict all implications of technological progress, but extensive precautionary restrictions will deprive us of all the potential synthetic biology holds for addressing pressing global issues of environmental change, sustainable bioproduction, and human health.

What we require in my opinion is a framework which constitutes a modification or extension of existing biotechnology regulation that is flexible enough to quickly accommodate unforeseen products of biotechnology/synthetic biology. Assessment of high-risk products may have to be conducted on a case-by-case basis at first, but will improve by experience. This may also require expansion of existing risk assessment procedures, as exemplified by Annex III: as assessment based on single trait transfer from donor to acceptor may be insufficient to account for a LMO resulting from of modern bioengineering techniques and involving complex biological circuitry, criteria may be modified to refer to the closest ‘natural’ relative for risk assessment. However, these details may be suitably addressed by the AHTEG in the future.

In a nutshell: while compounds and products of synthetic biology are not distinct from those derived from biotechnology in essence, a coordinated revision and expansion of existing biotechnology regulation in a spirit of flexibility may be necessary to account for acceleration in technological progress.

With best regards,
Christian R. Boehm
Chair of EUSynBioS
posted on 2015-07-05 21:35 UTC by Mr. Christian R. Boehm, European Association of Synthetic Biology Students and Postdocs
This is a reply to 7311 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7401]
Dear colleagues,

My name is Piet van der Meer and for much of my professional life I have been in charge of biosafety regulations at the Dutch Ministry of the Environment, in which capacity I have participated actively in the negotiations on biotechnology related parts of Agenda 21 and the Convention on Biological Diversity as well as the Cartagena Protocol on Biosafety. Since 2004 I teach about biosafety regulation and risk assessment, among others at the Universities of Ghent and Brussels, Belgium.

My thanks to Benson Kinyagia and Maria Torres for moderating the topics 6 and 7, which I take together in this post, as they are closely related as others have already said.  I am pleased to see that many contributors follow the plea of Benson and Maria to be concise, and I will try to do the same.

Topic 6 is: “Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques”.

As others have stated, this too broad a topic for an online discussion, as it would require a detailed analysis and discussion of national regulatory systems. I will therefore focus my contribution on the CBD, which in article 8g requires Parties to “….establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms….”, and the Cartagena Protocol, which offers a tool for informed decision making about transboundary movements for countries that have not yet establish a national system as referred to in article 8g of the CBD.

Given that current and near future applications of synthetic biology involve the use of organisms with novel combinations of genetic material obtained through the use of modern biotechnological techniques that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection, the national systems as referred to in article 8g of the CBD as well as the Cartagena Protocol apply. As a consequence, the case by case risk assessments of those systems apply, for which Annex III of the CPB gives clear directions about the risk assessment, and for which a wealth of tools developed by other bodies are available.

There have been some posts that suggest that where synthetic biology is not explicitly mentioned in national biosafety regulations, new regulatory systems have to be developed. This is an erroneous conclusion, because the fact that a national regulatory system does not explicitly use the term “synthetic biology” (or any other biotechnological technique for that matter), does not necessarily mean that the organisms used in those techniques are not covered by the definition of LMO (or GMO as in Europe).

There have also been posts that suggest that since the ‘regulatory trigger’ of the CBD and the CPB is a living organism and not non-living products, new regulatory systems have to be developed. I believe that this too quick a conclusion, because the sectoral product regulation (such as regulations for food, medicine, pesticides, et cetera) apply to the safety of those products. Those systems involve assessments, based on internationally agreed principles and methods developed under the Codex, the IPPC, the WHO etc.

In concluding, I concur with those colleagues who have said that at this point in time there is no need to establish additonal regulatory systems, but I  also endorse those who have suggested that we should keep monitoring and exchanging information about applications of synthetic biology, to assess whether there will at one point in time be applications that warrant prior risk assessment but do not involve the use of organisms that are covered by the definition of LMO.

Best regards to all,

Piet
posted on 2015-07-05 22:40 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 7401 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7404]
Dear colleagues,

I have followed the discussions with interest and would like to respond to both topic 6 and 7 in my comment, as these two topics are very closely related. I find myself in agreement with many contributors who find that current existing instruments are not sufficient or adequate to regulate organisms, components and/or products derived from synthetic biology techniques.

As pointed out by previous contributors, for us to assess the adequacy of existing instruments to regulate the organisms, components or products derived from synthetic biology techniques, we need to have at least the following in place:

a) an overview of all the instruments that cover or could cover the various aspects necessary to regulate organisms, components or products derived from synthetic biology techniques in line with the CBD decisions and obligations: The groundwork to this has been done to a large extent already by the secretariat in its report, on which further assessments can be built.
b) to have in place the criteria to assess adequacy for all the protection goals and aspects specified in the CBD decision and CBD obligations, including socio-economic aspects, impacts on livelihoods, indigenous peoples and local communities, food security, small scale farming and its contribution to feeding populations and maintaining biodiversity, amongst others.
c) The requirement for the strict application of the precautionary principle/approach – as was also pointed out in many of the contributions.

Adequacy would also require the integration of -or communication between- national, regional and international instruments to ensure that synthetic biology related activities in one location or party do not negatively impact biodiversity, livelihoods, socio economics, food security, indigenous peoples and local communities etc elsewhere.
In this I also want to crosslink to previous discussions, in particular to the aspect of ‘full life cycle’ analysis and related impact and risk assessments, as supply chains, production and dissemination often go across borders and even regions. This aspect would also need to be covered to achieve “adequacy”.

It is in about every thread/topic, that definitions and inclusions/exclusions are being brought up, and whether current definitions of LMOs are sufficient to cover organisms derived through synthetic biology. There seems to be a broad – though not unanimous – agreement that future applications will go beyond current definitions and/or current instruments and regulations. Whilst I agree that future applications of synthetic biology will clearly go beyond current definitions of LMOs/GMOs and are not sufficiently covered by current instruments and regulations, I think we already have applications that are not sufficiently covered at present, such as intentional (and unintentional) epigenetic changes through methods of RNA directed DNA methylation (RdDM). Though clearly holding risk implications, many of the RdDM techniques are not covered by current definitions of LMOs or GMOs.

And irrespective if current definitions of LMOs/GMOs are sufficient to cover “SBOs”,  I agree, that “organisms, components and products of synthetic biology techniques make up a broader category than LMOs as defined under the Protocol,” as pointed out in [#7348] (Lim Li Ching).  Furthermore, I find myself in agreement with all of submission [#7348].

I want to thank Deborah Scott [#7364] for her social science perspective and the specialised knowledge and references she brings into this discussion, as we are dealing with layers of complexities. For future deliberations I think it would be good to pick up on the points brought up by her, including he importance of “not reducing more intractable uncertainties to ‘risk’ alone.” 

With particular regards to topic 7, to the best of our knowledge, existing arrangements do not constitute a comprehensive framework to address impacts of organisms, components and products resulting from synthetic biology in line with the obligations under the Convention and its protocols.

Instead it is of concern, that in some countries and regions, including the EU, attempts are on the way to exclude or exempt genome editing techniques from GMO regulatory requirements. Yet genome editing techniques are an important constituent of synthetic biology applications, with associated risks and concerns.  

with kind regards,

Ricarda Steinbrecher
Federation of German Scientists
posted on 2015-07-05 23:50 UTC by Ms. Ricarda Steinbrecher, Federation of German Scientists (Vereinigung Deutscher Wissenschaftler)
This is a reply to 7404 RE: Opening of Discussion: Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques [#7405]
My name is Dr. Megan J. Palmer. I have several organizational affiliations related to synthetic biology policy and practice. I am a Research Fellow at the Center for International Security and Cooperation (CISAC) at Stanford University studying topics related to biotechnology governance.  I also served as the Deputy Director of the Policy and Practices research program within the Multi-University National Science Foundation (NSF)-funded Synthetic Biology Engineering Research Center (Synberc) for the last 4 years. I founded and am Executive Director of the Synthetic Biology Leadership Excellence Accelerator Program (LEAP) and have serve on the Safety and Policy and Practices committee for the international Genetically Engineered Machine (iGEM) competition.  The views I present here are my own, and do not represent the official positions of these organizations.

I thank the moderator for facilitating this important discussion and for the opportunity to participate.

“Synthetic biology” has come to signify a heterogeneous ensemble of techniques distinguished foremost by the principles and approach motivating their development and application. Synthetic biology can be in most cases considered an extension of biotechnology (or, as Robert Friedman [#7381] notes, “Biotechnology 2.0”) rather than a unique set of techniques, applications or products. Narrowly defining additional regulations specific to “synthetic biology” is likely to be counterproductive to maturing our governance systems related to broader advances in biological science and technology.

While most products currently fall within existing regulatory systems, a significant challenge is in designing processes that can efficiently and robustly apply and adapt frameworks when faced with an increasing number and diversity of applications enabled through biotechnology/synthetic biology.

I note Todd Kuiken’s comments [#7396] that in the US, the Coordinated Framework “needs to be updated, periodically reviewed, and made adaptable … to provide a transparent process for both companies and the public to understand how the process is conducted”. The recent Directive from the US Office of Science and Technology Policy regarding “Modernizing the Regulatory System for Biotechnology Products” is an important step. Complementary efforts in other countries and at the international level should also support goals of improving transparency, coordination, predictability, and efficiency.

Megan J. Palmer, Ph.D.
posted on 2015-07-06 00:59 UTC by Ms. Megan Palmer, Stanford University