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Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7312]
POSTED ON BEHALF OF MARIA TORRES
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Dear Forum Participants,

My name is Maria Torres from Ecuador and for me is a great pleasure to moderate this new round of discussion within the Forum on Synthetic Biology. I would like to thank the Secretariat for this opportunity and I would like to welcome all of you to the discussion on Topic 7:¨” Degree to which the existing arrangements constitute  a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity“, which begins today until July 6th.

Building on the views shared during the previous rounds of discussion, and in particular the interventions posted under topic 2 (https://bch.cbd.int/synbio/open-ended/pastdiscussions.shtml#topic2), and, in particular, taking into account the discussions under topic 6 on “The adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques“ (https://bch.cbd.int/synbio/open-ended/pastdiscussions.shtml#topic6), I would like to invite you to consider, within the mandate of the Convention and its Protocols:

• To which degree do existing arrangements, i.e. the national, regional and international instruments that apply to the organisms, components or products derived from synthetic biology techniques, constitute together a comprehensive framework to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity?

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 112-113; available at http://bch.cbd.int/synbio/cbd-ts-82-en_topic7.pdf).

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

So I invite you all to have a fruitful conversation on this topic in order to share interesting information which would allow us to have a better idea of the existing arrangements that can address organisms, components and products derived from synthetic biology.

Kind regards,
Maria
posted on 2015-06-22 01:45 UTC by Dina Abdelhakim, SCBD
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7316]
¡Hola María! Thanks to you and the Secretariat for initiating this topic 7 which to me is fundamental.
I will be concise as possible and not repeat many of what has been said before. It is true that there are aspects that may need to be further discussed on synthetic biology (i.e. the gaps pp 112&113) encountered and described in the conclusions put forward to us, but to me, what is now available certainly covers, in regulatory terms, the main aspects and precocupations derived from the application of Synthetic Biology in relation to its possible impacts on biological diversity. What is urgent is to recognize this and regulate accordingly what is now being developed and used. Better sooner than later.
A very important effort must be made to join the different actions of the diverse international bodies (hopefully through the coordinated action of the CBD Secretariat) to working on a synergistic and complementary process towards attending the needs of coordination  in current regulatory frameworks, as well as planning coordinated work towards reducing the gaps identified.
An AHTEG will be established to work on these aspects soon. I invite this AHTEG to work coordinately with the AHTEG on Risk Assessment , as well as the AHTEG on Socioeconomic Aspects, both under the Cartagena Protocol. Coordinated work will be fundamental.
Kind regards to all,
Francisca
posted on 2015-06-22 14:58 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7317]
Dear participants of the Online Forum on Synthetic Biology, good day.
My name is Josephine Therese Makueti and I work in collaboration with the Ministry of Environment, Protection of Nature and Sustainable Development in Cameroon (Central Africa). I am a Tree Breeder Scientist newly appointed by the CBD Focal Point of my Country, as Synthetic Biology Expert. My background is within genetics and gene technology and my Ph.D was on breeding system of Dacryodes edulis, an indigenous tree species widely cultivated and commercialized in West and Central Africa. Furthermore, I have been selected to attend to the African Plant Breeding Academy-Class II, scheduled in three Sessions of 15 days in Nairobi, Kenya, within the African Orphan Crops Consortium –a NEPAD-led initiative.
Although I joined the forum a bit late, I express my sincere thanks to the Secretariat and moderators for coordinating this online forum, I appreciated participants’ contribution. Hence, I have been following the discussion under this forum with much interest and thank all who have contributed to a rich and lively debate so far. I wish to contribute to discussions on Topic 6: Adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques and Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity.
First of all, I wish to remind that my country (Cameroon) is Member of Convention on Biological Diversity since 1994. Our Government signed the Cartagena Protocol on Biosafety on the 09th February 2002, ratified it on the 20th February 2003. Its date of entry into force was 11th September 2003 (see Country profile on Biosafety Clearing-House). With regard to topics mentioned above, I wish to share with you some of my country’s positions:
For general provisions, law governing modern biotechnology has been enacted by the National Assembly; implementation texts are still at an advanced stage of development; a manual on Risk Assessment Management has been developed.
As far as advance informed agreement procedure is concerned, there is a legal requirement for the accuracy of information provided by exporters (Article 8.2 of the Protocol) under the jurisdiction of the country; decisions regarding import under domestic regulatory frameworks as allowed by Article 9.2(c) were taken;
There is a legal requirement for the accuracy of information provided by the applicant with respect to domestic use of living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11.2), especially at this moment that my country is facing a huge number of refugees from Nigeria (Boko Haram attacks) and Central Africa Republic (civil conflicts between Anti-Balaka & Seleka).
Likewise, measures are taken (in the country Biosafety Law and texts of application) to require that living modified organisms that are subject to transboundary movement within the scope of the Protocol are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards (Article 18.1). This is also the case of documentation accompanying the living modified organism. Nonetheless, our Law shall be revised to replace “contain” by “may contain” in Article 18.2 (a).
Indeed, Cameroon has not yet taken Decisions for the provision of information to the Biosafety Clearing-House because the decision procedure for import/export of GMOs is not yet put in place.
Cameroon has not yet entered into any bilateral, regional and multilateral agreements and arrangements with regard to provision of information to the Biosafety Clearing-House. But we are not left behind as the government is struggling to strengthen National experts Capacities on the task.
posted on 2015-06-24 09:39 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 7316 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7319]
POSTED ON BEHALF OF JONATHAN MUFANDAEDZA
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I am Dr jonathan mufandaedza. I agree with Franciscan and I also want to underscore the need to improve the regulatory frameworks in developing countries so that they don't act as impediments to the comprehensive framework, otherwise these countries will remain as gaps.
Thanks
posted on 2015-06-24 14:27 UTC by Dina Abdelhakim, SCBD
This is a reply to 7319 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7320]
Dear Maria, dear All,
I am following with interest the discussion in the previous rounds on the possible benefits and impacts of synbio, the state of its covering by the international agreements, sufficiency of national capacities to ensure safety use of the synbio components, organisms and products etc.  I will join the opinion of many participants and the conclusions (pp.113-114) that stated that synbio is a new big challenge. Although it is a topic of a number of international rules, however the possible impact of Synbio to  biodiversity and in the transboundary context should be a topic of special attention of the CBD. There exist a range of uncertainties of the Synbio applications and at the same time no specific standards or guidelines agreed to estimate their potential impacts. The existent capacities of the countries to ensure safety from Synbio are limited and covered fragmentary by Biosafety (LMOs), Phytosanitary or trade domestic regulations. However there is no specific rules and practical procedures in place addressed to synbio and its effects to conservation and sustainable use of biodiversity, including genetic diversity and the benefit sharing aspects. A further discussion at the international level is important to continue that, in my opinion, can lead to a new specific agreement (protocol) under the CBD/CPB on the specific Syntethic biology item, taking into consideration the magnitude of the problem and expected development of application of Synbio in the future.
I support the suggestion made by Francisca that it will be helpful to ensure the collaboration framework of the Synbio AHTEG with the AHTEGs on risk assessment and socio-economics under the Cartagena Protocol.

Best regards,

Angela Lozan
Moldova
posted on 2015-06-25 07:39 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 7320 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7323]
Dear Forum Participants,
First of all, I would like to thank you for all your contributions on this Forum. Following your interventions, it is clear than an effort is needed to compile the different arrangements, country regulations and actions of  diverse international bodies to have a comprehensive panorama on how to proceed in order  to define an appropriate framework that can address the  impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity.  
It is clear, too, that the work of the AHTEG that will soon be established is crucial for achieving a more complete view of what is needed to address the topic of Synthetic Biology. It has been suggested that it would be important for the AHTEG on Synthetic Biology to work in coordination with the AHTEG on Risk Assessment, as well as with the AHTEG on Socioeconomic Aspects under the Cartagena Protocol.
For this process, it is very important to know the diverse opinions that exist on this subject, which is why I kindly invite you to further participate in this discussion in order to reach conclusions that can guide us.
This Forum is open until July 6th, and I look forward to your enriching contributions.
Best Regards to all,
Maria
posted on 2015-06-26 04:37 UTC by Ms. Maria de Lourdes Torres, Ecuador
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7325]
Many thanks again for the opportunity to provide comment.

As mentioned in other posts, New Zealand undertakes risk assessment through the Hazardous Substances and New Organisms Act (HSNO Act), which would likely regulate organisms produced through synthetic biology. This Act: regulates both new organisms (including GMOs/LMOs) and hazardous substances (with defined intrinsic properties); considers both environmental and human effects; and decides on applications for import, development, containment or full release into the environment. At a national level, the HSNO Act provides an adequate framework to address the impacts of organisms, components and products resulting from synthetic biology.

The adequacy of existing, regional and/or international instruments will depend to a large extent on what is being regulated. Numerous posts on the online forum have provided views on the extent which organisms of synthetic biology are covered by the Cartagena Protocol. Conducting a meaningful and thorough analysis of the adequacy of regional/international instruments is currently not feasible without an agreed definition of synthetic biology and additional detail about regulatory instruments not covered in the CBD documents (e.g. SAICM, etc.).  

Kind regards,
Mariska Wouters
New Zealand Ministry for the Environment
posted on 2015-06-26 05:02 UTC by Ms. Mariska Wouters, New Zealand
This is a reply to 7325 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7326]
Dear Participants, good day.

I am Josephine Therese Makueti Form Cameron (Central Africa).
I am very thankful to all of you who have posted great information within this forum’s
framework.
As you can realize, African participants are merely or almost left behind.
I fully agree with Ms. Mariska Wouters from New Zeland. Indeed, conducting a meaningful and thorough analysis of the adequacy of regional/international instruments is currently not feasible without an agreed definition of synthetic biology and additional detail about regulatory instruments not covered in the CBD documents. Therefore, CBD documents need some revision.

With warm regards,

Josephine Therese Makueti
On behalf of Cameroon Ministry of Environment, Protection of Nature  and Sustainable development.
posted on 2015-06-26 07:52 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7327]
Dear colleagues and participants,

I’m  Dr Lázaro Regalado  (Cuban National Center for Biosafety. Ministry of Science, Technology and Environment) I would like to congratulate Maria de Lourdes Torres who is kindly inviting us to participate in this discussion and the wise Secretariat decision to balance the regional participation of moderators.

Regarding Topic 7:¨” Degree to which the existing arrangements constitute a comprehensive framework ……¨ in my view there are many issues on the table if we want to reach a full analysis based on the identification, examine and evaluation of each one:

• To which degree do existing arrangements constitute together a comprehensive framework to address impacts resulting from synthetic biology?
• The adequacy of existing national, regional and/or international instruments to regulate the organisms, components or products derived from synthetic biology techniques (Topic 6) very much related.
• Accidental or unintentional release to the environment
• Intentional release to the environment or other non-peaceful purposes including bioterrorism.
• The dual use nature of the technology
• Interaction of risk factors, cumulative effects, synergic effects …..
• Unintended hazards
• Uncertainty which is very much related with risk that may arise from different points of view in research data or design of the investigation.
• ……
Because of the matter of time and as brief as possible I would like to highlight one of them:

To which degree do existing arrangements constitute together a comprehensive framework to address impacts resulting from synthetic biology?
As far as I can see there is almost a consensus with regard to the existing Risk Assessment framework that is enough to address the issue, but I’m not quite sure, let’s say I agree with this view but at the same time I think that we should complement the approach. If we look at the research stage in general and as an example it takes place at facilities with a design phase and afterwards in laboratories at the stage of contained use, the most important stage in my view in terms of Biosafety and Biosecurity and we are not talking about the release or trans-boundary movement of the organism yet. The guidelines to risk assessment in Annex III of CP is valid but not enough to apply to some organism resulting of SB techniques, hence the contained use should be in relation with different levels of containment as a result of a previous risk assessment and the tools are available on the classic Biosafety and Biosecurity when we talk about facilities with biological risk.
The general tools are:
• CWA 15793:2008, Laboratory biorisk management standard.
• CWA 15793: 2011 Laboratory biorisk management standard
• CWA 16393: January 2012 Laboratory biorisk management - Guidelines for the implementation of CWA 15793:2008
• UNE-CA 15793: Julio 2013 Gestión del riesgo biológico en el laboratorio. AENOR. Asociación Española de Normalización y Certificación.
• UNE-CA 16393. Junio 2014. Gestión del Riesgo biológico en el laboratorio. Guía para la aplicación del CWA 15793:2008
See topic 4 [#7217] for the rationale and specific risk assessment tools.

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

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

Kind regards,
L. Regalado
(edited on 2015-06-28 14:32 UTC by Mr. Lazaro Regalado)
posted on 2015-06-27 23:40 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7329]
Dear participants and moderator, thanks for the opportunity to provide comments. 

I would like to raise the issue of Biosafety and Biosecurity
There are differences in Biosafety definitions in the CP framework and other areas but in my view with similar goals, hence also apply as a complementary need. 

¨¨Under the Convention on Biological Diversity (CBD), and more specifically under the Cartagena Protocol on Biosafety (hereinafter “the Protocol”), the term biosafety essentially refers to safety procedures aimed at regulating, managing or controlling the risks associated with the use and release of LMOs resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account risks to human health. Biosafety comprises multidisciplinary scientific fields including, but not limited to biology, ecology, microbiology, molecular biology, animal and plant pathology, entomology, agriculture and medicine as well as legal and socio-economic considerations, and public awareness¨.
¨In its broad sense, the term biosafety refers to the protection of human health and the environment from potential harm due to biological agents¨ Module 1: Overview of Biosafety and the Cartagena Protocol on Biosafety. Risk Assessment of LMOs - Training Manual

“Laboratory biosafety” is the term used to describe the containment principles,
technologies and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release. “Laboratory biosecurity” refers to institutional and personal security measures designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins.¨
¨Effective biosafety practices are the very foundation of laboratory biosecurity
activities. Through risk assessments, performed as an integral part of an institution’s biosafety programme, information is gathered regarding the type of organisms available, their physical location, the personnel who require access to them, and the identification of those responsible for them. This information can be used to assess whether an institution possesses biological materials that are attractive to those who may wish to use them improperly. National standards should be developed that recognize and address the ongoing responsibility of countries and institutions to protect specimens, pathogens and toxins from misuse¨. WHO Laboratory biosafety manual. – 3rd ed.2004

¨Biosafety and Biosecurity
Biosafety and biosecurity are related, but not identical, concepts. Biosafety programs reduce or eliminate exposure of individuals and the environment to potentially hazardous biological agents. Biosafety is achieved by implementing various degrees of laboratory control and containment, through laboratory design and access restrictions, personnel expertise and training, use of containment equipment, and safe methods of managing infectious materials in a laboratory setting.
¨The objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information. While the objectives are different, biosafety and biosecurity measures are usually complementary.¨
The term “biosecurity” has multiple definitions. In the animal industry, the term biosecurity relates to the protection of an animal colony from microbial contamination. In some countries, the term biosecurity is used in place of the term biosafety. For the purposes of this section the term “biosecurity” will refer to the protection of microbial agents from loss, theft, diversion or intentional misuse. This is consistent with current WHO and American Biological Safety Association (ABSA) usage of this term.¨ Biosafety in Microbiological and Biomedical Laboratories 5th Edition, HHS Publication No. (CDC) 21-1112Revised December 2009.

Kind Regards,
  L. Regalado
posted on 2015-06-28 18:44 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7329 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7335]
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.

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

Gantz, V.M., & Bier E. (2015). The mutagenic chain reaction: A method for converting heterozygous to homozygous mutations. Published Online March 19 2015, Science DOI: 10.1126/science.aaa5945
posted on 2015-06-30 19:20 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 7323 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7336]
As noted in my response to Topic #6, Evolva has operations in Switzerland, Denmark, the UK, India, and the US. All of these countries have a long history with biotechnology. The synthetic biology branch of biotechnology is not novel in these countries, it has been evolving within the broader genetic engineering construct for many years now.

Indeed, in all of these countries, numerous big-picture studies and reviews have been conducted, and will certainly be refined and expanded in the future.

There are a comprehensive set of laws in place in all of these countries to regulate ALL aspects of biotechnology. Existing arrangements in these countries constitute a comprehensive framework to address the myriad potential impacts on biodiversity from ALL forms of biotechnology, including synthetic biology.

Still, if society is to benefit from all of the hard work at the CBD to put synthetic biology in proper perspective, it is a fair point that we are going to need to define and contextualize what is actually meant by words such as "comprehensive", "potential", and "impacts".

Sincerely,
Stephan Herrera
Evolva
posted on 2015-06-30 19:26 UTC by Mr. Stephan Herrera, Evolva
This is a reply to 7335 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7337]
Dear Colleagues:

I am an independent conservation biologist and a member of IUCN's protected area and species specialist groups.  I have followed with interest all of the learned posts and have learned a great deal.

I wish to make an observation similar to one I made in response to one of the previous questions.  The assumption behind most of the remarks is that organisms modified by synthetic biology will be bad for people and nature.  There is interest, however, in using genomic technologies to help restore lost genetic diversity to endangered species, or move traits from extinct species to closely related species to help them adapt to climate change.

I am not a student of the various national and global frameworks but would be interested in having this group assess the adequacy of existing legislation to regulate such possibilities.

Thank you.
posted on 2015-06-30 19:53 UTC by Mr. Kent Redford, Archipelago Consulting
This is a reply to 7325 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7339]
I am also in agreement with Mariska Wouters of New Zealand.  Canada has a similar regulatory regime.  For some of us, the way to think about synthetic biology is simply to call it ‘biotechnology 2.0’.  If your country has an adequate regime for living products of biotechnology, that includes an environmental/biodiversity endpoint, then living products of synthetic biology are likely covered as well.  Whether this constitutes a ‘comprehensive framework’, which is the question we are asked to address, would require a comprehensive survey to answer.

The question posed here was: • To which degree do existing arrangements, i.e. the national, regional and international instruments that apply to the organisms, components or products derived from synthetic biology techniques, constitute together a comprehensive framework to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity?

The answer, for most countries, will lie in the adequacy of national environmental risk assessment laws, regulations and guidelines.  Environmental risk assessments of organisms, ‘components’ (does anyone have examples of these?) and (non-living?) products will ensure that any identified risks are accounted for or are managed while ensuring that organisms and products that are not harmful to biodiversity, have the possibility to enter the market. 


Jim Louter
Environment Canada
posted on 2015-06-30 20:41 UTC by Mr. Jim Louter, Canada
This is a reply to 7339 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7342]
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.

There are many international arrangements for addressing the safety of different products, whether they are chemicals, living organisms, pharmaceuticals, or other substances and products produced from biological engineering or otherwise. Some of the most relevant organizations where countries and relevant stakeholders develop, share, and implement safety guidelines and practices include the World Organisation for Animal Health, the International Plant Protection Convention, the World Health Organization, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the Organisation for Economic Co-operation and Development. It is our opinion that new frameworks to address biological engineering or resulting products are not needed, and that existing ones together can address the safety of the products from biological engineering.

Sincerely,
Genya V. Dana
posted on 2015-06-30 22:18 UTC by Ms. Genya Dana, United States of America
This is a reply to 7342 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7343]
Dear all participants and moderators in this online forum,

Thank you very much to CBD secretaries and all moderators from topics 1 to 7 for their assistances and efforts to operate this complicate online forum.  Thank you for all participants, too.  I indeed learnt there are a variety of thoughts about the emerging issue, “Synthetic Biology”, its risk assessment methonologies and socioeconomic aspects.

Topic7; “Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity.”

As Ms. Mariska Wouters[#7325] and Mr. Jim Louter[“7339] stated, Japan also undertakes all risk assessments of organisms and products derived from genetically modified technology(including synthetic biology), with case by case procedures, under the existing laws and regulations  We do not meet any problems in such systems.
For example, LMO(living “Products”) is covered by Japanese Cartagena laws which has stricter requirements to the users of genetic engineering technology than those defined in the original Protocol, and the operations of risk assessments are performed separately item by item by six ministries of Japanese Government.   Chemical substances are also regulated some strict laws and regulations, such as the Pharmaceutical Affairs Act for pharmaceutical drugs, CSCL regulation, Industrial Safety and Health Law, Poisonous and Deleterious Substances Control Law, and PRTR law for chemical substances and so on.  It is not necessary for us to set up any new regulations for the “ Synthetic Biology”

Meanwhile I agree with Ms. Mariska Wouters’s comment[#7325] , “Conducting a meaningful and thorough analysis of the adequacy of regional/international instruments is currently not feasible without an agreed definition of synthetic biology and additional detail about regulatory instruments not covered in the CBD documents”.
I would like to propose that the discussion about the definition and its defined scientific range of “Synthetic Biology” should be raised as the most priority theme in the coming AHTEC.  Without such definition and its defined scientific range, it will be impossible to make any mutual agreement in this discussion.  Then we discuss the gaps between the specified technology and regulations (risk assessment systems).

On the other hand, it is also true that many participants may be agreed that at the moment all organisms obtained by synthetic biology are considered to be GMOs (or LMOs) and such GMOs(or LMOs) could be applied for the current risk assessment framework. Therefore, most of organisms obtained by synthetic biology don’t make any problems by evaluating the existing regulatory systems (product by product, case by case evaluation) under the CP without any mutual consensus about the definition of “Synthetic Biology”.

Some argued in the online form that the current regulation procedures, such as Cartagena Protocol, were not inadequate, but it seems not to be presented any clear evidences and/or examples in this online forum.  Even if such evidences and examples would appear, as I stated above, our current laws and regulation systems in Japan can applied for “Organisms” and “Products” (maybe “Components” , but the definition is still obscure) derived from the “Synthetic Biology”.

I hope the discussion on this complicate issue will be ended in success in the coming AHTEG.

Hideyuki
posted on 2015-07-01 02:05 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7345]
Dear Participants and Moderator,

Thank you for the opportunity to participate in these discussion sessions and to provide comments.  I am Dr. Rina Singh, Senior Director, Policy, Science and Renewable Chemicals, and I represent the Biotechnology Industry Organization’s (BIO) Industrial and Environmental  Section, which is the world’s largest biotechnology organization, providing advocacy, business development and communications services for more than 1,000 members worldwide, including companies developing products with synthetic biology.  BIO member companies are involved in the research and development of innovative healthcare, agricultural, and industrial and environmental biotechnologies.
We consider synthetic biology not to be new but rather an ongoing extension in the continuum of genetic engineering science, which has been used safely for more than 40 years by the biotechnology industry in the development of medicinal and everyday consumer products that provide societal benefits.  Synthetic biology represents an application of biotechnology that fits within existing regulatory frameworks. As such, we disagree with the contention that any new or special regulatory tools and/or regime are needed beyond the established U.S. Coordinated Framework under which products of biotechnology are regulated today within the United States.   Certainly, synthetic biology can be a useful tool, but existing regulatory frameworks protect biosafety and biodiversity, since they are rooted in the science itself.  The precision of synthetic biology technologies and tools make the genetic manipulations predictable and safer relative to the traditional petrochemical processes.
As with any other technology, products made with and from synthetic biology should be regulated based on their risks, and as well as benefits, as delineated in the U.S. Coordinated Framework. The process or technology should not be regulated in isolation, as it is not inherently more risky than other technologies. Today, synthetic biology research and production techniques undergo rigorous risk assessment, where risk is equal to hazard times the exposure.  As a biotechnology industry trade association, we are concerned that, while the focus of the discussions has been targeting the existing regulatory framework for synthetic biology, emphasis is being made on risks alone and not benefits, which the science delivers in drug design, development of biobased products, advanced biofuels, food ingredients, and agricultural diversity.
Under the U.S. Coordinated Framework, multiple U.S. agencies regulate various aspects of the biotechnology industry. The United States has federal NIH guidelines used in laboratory research and development, and as of March, 2013, the guidelines were modified to include synthetic biology. The guidelines apply to any research that receives federal support and are voluntary for others. The U.S. Environmental Protection Agency regulates chemicals and microbes produced through synthetic biology. The USDA’s APHIS oversees any potential threat to agriculture; and the FDA oversees any health applications. Since microbes are treated as a product of biotechnology, their use is already regulated.
Additionally, the U.S. Federal Bureau of Investigation monitors – with the assistance of industry participants – the transfer or sale of DNA code snippets that could be used for dual purposes. A recent review of the U.S. regulatory system for synthetic biology failed to find any convincing gaps.
The U.S. Coordinated Framework has worked well for more than 40 years, enabling new products made with biotechnology to enter the marketplace. Products that have been developed with synthetic biology and have been commercialized safely and successfully include BioIsoprene™ – a chemical used in the manufacture of tires – and vanillin – which is a replacement for chemical vanilla flavoring. Throughout its history, the biotech industry has demonstrated a strong record of safety under a regulated framework.

Sincerely,
Dr. Rina Singh
(edited on 2015-07-01 06:05 UTC by Ms. Rina Singh)
posted on 2015-07-01 06:01 UTC by Ms. Rina Singh, Biotechnology Industry Organization (BIO)
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7350]
I thank the moderator of this discussion for providing the opportunity to add to the ongoing discussion. My name is Jaco Westra and I work for the Netherlands National Institute of Public Health and the Environment (RIVM).

Referring to the question as has been drafted by the moderator, I would like to bring the following elements into the discussion:
- if comprehensive framework means a world wide, coherent and mutually balanced set of principles then the answer would have to be: no. There are e.g. several types of regulation, differing in its scope of application and implementation throughout the world. Even in Europe, although based on the same set of legal rules there are distinct differences in implementation.
- If comprehensive framework means do we have it all covered in some sort of way on the level of: knowing the general categories of application and having the instruments to address questions on risks and impacts for each of those categories (e.g. organisms, components, products) the answer would be: most likely
- Also it should be clear that such a framework – covering all aspects related to  synbio from the perspective of and organisms, and components and products – is most likely best seen as ‘ patchwork’ and not  as ‘coherent’ by definition.  That is, instruments, principles and approaches developed for e.g. LMOs will differ significantly from those developed for e.g. products (e.g. chemicals). 
- As always the devil is in the detail and case-by-case assessments is necessary, also to provide the empirical knowledge to drive the process of understanding further.

One of the challenges of the AHTEG will be to get a better and clearer picture of this ‘patchwork’ and identify on a more detailed level if and where additional information and/or measures will be called for.

Looking forward to the continuing discussion on these topics.

Kind regards,

Jaco Westra
RIVM
The Netherlands
posted on 2015-07-01 13:25 UTC by Mr. Jaco Westra, Netherlands
This is a reply to 7350 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7355]
Dear participants,

Thank you again for the opportunity to participate in this on line forum.

I think Dr. Jaco Westra summarize very well the SynBio AHTEG challenge: ´...to get a better and clearer picture of this ‘patchwork’ and identify on a more detailed level if and where additional information and/or measures will be called for.´ [#7350]

Although I agree that currently GMO risk assessment framework can be used to assess impacts of SynBio organisms and the consideration of a ´benefit assessment´ is a very important point for decision-making regarding this technology I think is very premature to consider a coordinated work among SynBio AHTEG, RA AHTEG and SEC AHTEG under CPB. I think SynBio AHTEG will have first to work in very basic concepts to better understand ‘if the existing arrangements constitute a compreehensive framework’ with the various contributions from different topics in this on line forum.

Best regards,
Luciana P. Ambrozevicius / Ministry of Agriculture - Brasil
posted on 2015-07-01 19:10 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 7355 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7356]
Dear all:
The point I tried to make earlier about needing "coordinated work" between the different AHTEG´s is because I see a neccessity of reacting fast, trying to keep up with tech developments. I think there is no reason not to do so, specially if the other AHTEG´s already exist.
Synthetic biology organisms/products/components already exist (as documented in the CBD review), nevertheless we have detected cases were these have not undergone any regulation at all.
Kind regards,
Francisca
posted on 2015-07-01 19:41 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7361]
Dear all, 

Thanks to the moderator and all other participants in this lively discussion. My name is Boet Glandorf and I work as a senior risk assessor at the GMO Office in the Netherlands.

The question of this discussion is whether the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity

I would like to separate the potential impacts on biodiversity of organism obtained by synthetic biology on the one hand and components and products on the other hand.

Organisms obtained by synthetic biology
As other participants have indicated before, at the moment we have a comprehensive framework to address potential adverse effects on biodiversity of organisms resulting from genetic modification which is also applicable for organisms obtained by synthetic biology. However, no framework is perfect and it is good to critically assess the existing framework for LMOs in the light of new developments in synthetic biology.
The major issue will be if and how organisms obtained by synthetic biology will be adequately assessed in case they no longer fall under the definition of an LMO. The interpretation what is considered to be an LMO (or not) is crucial in this respect. Recent technological developments are already initiating fierce debates with respect to the regulatory status of organisms obtained with these new technologies.

Component and products
Although it is still unclear to me what is exactly meant with ‘components and products of synthetic biology’, these are assumed to be non-living components and products. At the moment there are already products and components of LMOs on the market that are assessed under the diverse product regulations. The question is if we can already identify gaps in the assessment of LMO-derived products under the diverse product regulations. The second question would be if it is to be expected that more gaps are foreseen for components and products of synthetic biology derived from organisms that no longer fall under the definition of an LMO.

Keeping track of new developments in synthetic biology as well as in genetic modification is crucial since these areas are greatly overlapping and discussions on risk assessment are similar. Coordination between the RA AHTEG and SynBio AHTEG from the beginning is therefore important to adequately respond to new developments in synthetic biology in relation to potential negative effects on biodiversity.

Kind regards,
Boet Glandorf
posted on 2015-07-02 14:10 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7367]
Dear Colleagues,

My name is Mike Paton from the UK's Health and Safety Executive). Thanks once again for the opportunity to contribute to the discussion.

The overlap between synthetic biology and modern biotechnology is such that it is very difficult to tease them apart from a regulatory perspective and even more difficult at the practitioner level. Application of the EU regulatory system to current LMOs produced by synthetic biology or modern biotech works effectively to ensure the threats of significant reduction or loss of biological diversity are prevented. The national regulatory authorities have access to expert independent scientific advice (eg in the UK, Scientific Advisory Committee for Genetic Modification (Contained Use) (1) and Advisory Committee for Releases into the Environment (2)) to take account of advances in scientific techniques/technologies and to ensure that decisions are fully informed and are evidence based. As mentioned by others, the definitions, the competence of the scientific committees and risk assessment methodology may need to be adapted to cater for future developments and ensure the regulatory system remains effective. Similarly, for non-living synthetic biology products, there is a plethora of sector specific regulatory processes that need to be met for the different end uses.

There are clearly different regulatory approaches to synthetic biology internationally (even within the EU, where Member States transpose shared directives into national legislation, there are some differences). For example, the ‘process driven’ approach to GMOs in the EU directives contrasts with the ‘product based’ approach in Canada and New Zealand. The hypothetical example put forward by Testbiotech, whichever regulatory process is followed (product or process), would not receive market authorisation until the relevant risks had been addressed. The vast majority of actual examples of synthetic biology derived organisms involve activities in contained use and are of no or low risk. Where there is an absence or a gap in national regulatory systems (for example, not all parties to CBD have implemented the Cartagena Protocol on Biosafety), there is a need to encourage adoption of appropriate existing regulatory processes. This is a role that that CBD are already engaged in, particularly with respect to capacity building across the parties (3).

One issue with the regulatory approach in the EU, with respect to deliberate release of LMOs that has been raised, is its overly precautionary approach to authorisations, as illustrated by the number of GM plants authorised for cultivation in the EU (4, 5). Conversely, a large number of GM plants are grown worldwide, approved through different yet robust regulatory processes. Comparative analysis of experience in applying these different approaches is important for optimising the regulatory approach in the future, the current versions of which, whilst adequate to ensure the risks of negative impacts do not materialise, may need adjustment to realise the benefits to biodiversity.

The regulatory frameworks rightly focus on direct impacts on safety and harm to the environment but are less applicable to the wider and indirect socio-economic impacts. The Forum for the Future (with support from BBSRC and Friends of the Earth) have recently published a toolkit or ‘Deliberation Aid’ (6), which may help address some of these issues, and has the potential, if applied proportionately to relevant products, to address this identified gap. This approach would seem more appropriate than trying to implement legislation in this area.


(1) http://www.hse.gov.uk/aboutus/meetings/committees/sacgmcu/
(2) https://www.gov.uk/government/organisations/advisory-committee-on-releases-to-the-environment
(3) http://bch.cbd.int/protocol/cpb_art22.shtml
(4) http://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news/report-gm-precautionary-principle/;
(5) Heap, B. (2013). Europe should rethink its stance on GM crops. Nature 498, 409.
(6) http://forumforthefuture.org/project/making-deliberate-decisions-synthetic-biology/overview
posted on 2015-07-03 09:03 UTC by Mr. Michael Paton, United Kingdom of Great Britain and Northern Ireland
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7369]
POSTED ON BEHALF OF MARIA TORRES
-------------------------------------------

Dear Forum Participants,
I would like to thank again all the participants who have shared their views with us so far in our discussion about the “Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity”
Since on Monday, 6 July at 1:00am GMT this Forum will be closing as scheduled, I would like to encourage more participants to share their views with us over the next few days. 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.
Thank you so much 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.

Kind regards,
Maria
posted on 2015-07-03 15:41 UTC by Dina Abdelhakim, SCBD
This is a reply to 7369 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7370]
Dear Maria, dear all,

I am Maria Mercedes Roca, currently Foreign Visiting Professor of Biotechnology at the Tec de Monterrey in Mexico and  member of the  Risk Assessment AHTEG of the CBD.

Many thanks for the opportunity to contribute to this important discussion and many thanks Maria for  moderating this topic.

The views are again divided on this topic, with some feeling that we need new and rigorous biosafety frameworks to “protect” biodiversity and human health from the possible risks of synthetic biology, while others, mostly from  industry and agencies responsible for biosafety of biotechnology in industrialized nations, feel that biotechnology biosafety frameworks adequately  regulate developments in synthetic biology. This  reinforces  the view that synthetic biology is a continuum of genetic engineering and biotechnology. I support this view, while also recognizing that responsible, constant review and a case-by case approach is necessary.

I am, however, concerned for the newly constructed  biosafety frameworks in many developing  nations, especially in least developed countries, that tend to have  overly precautionary overtones, perceiving biotechnology (GMOs specifically) as dangerous and non-desirable, despite the vast evidence pointing to the contrary.  In my humble opinion, this brand of biosafety frameworks,  put enormous financial  pressure on already struggling governments and  stifle innovation and the adoption of useful technologies, often in countries that need it the most,  where agriculture is the main economic activity.

My concern is that this  type of overly precautionary and rigorous biosafety approach will continue into the regulatory frameworks for  organisms, products and  components  of synthetic biology, further increasing the gap between those countries using advanced technologies and those who don´t. 

Some contributors have also stated that the synthetic biology AHTEG and the Risk Assessment and the socio-economic AHTEGs should  work together. This makes obvious sense if indeed we: 1)  agree on a definition of synthetic biology  as a continuum of biotechnology; 2) members of the Risk Assessment AHTEG agree on the best approach to conduct a risk assessment, as there are many approaches used in different countries and regions. 

I look forward to continuing reading the interesting and important views on this matter.

Maria Mercedes Roca
posted on 2015-07-03 16:32 UTC by Ms. Maria Mercedes Roca
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7374]
Dear all,

I thank the Moderator and the Secretariat for the opportunity to participate in this forum. It has been a very interesting  experience to read  so many  postings that  enrich the discussions. Thanks to all and everyone.

Legal instruments addressing the use of biotechnology in general and LMOs have been developed in many countries. If they constitute a really “comprehensive framework” in order to address impacts of organisms, components and products form SYNBIO might need a very detailed analysis (considering, among many aspects,  the “organisms vs components and products”  issue). What needs to be kept in mind is that the regulation of Synbio organisms, components and products is a short term necessity, and finally the actually existing framework is what can be more helpful to do it in this moment, although it might be improved and that the eventual necessary adjustments will need to be done.
 
In the case of SYNBIO organisms, as it is the case of LMO, it is important to consider that technical aspects (i.e. Risk assessment considering  effects i.a. on the conservation and sustainable use of biological  diversity, etc., with the actual methodologies, or in an “adjusted” version if the  particular synbio organism deserves it ) need to be tightly linked to decision making derived from the application of the regulatory instruments  (although this might probably seem to be obvious for some), in order to try to effectively address the impacts of SYNBIO, as for  particular threats  of significant reduction or loss of biological diversity. 

I agree with those that think that a coordinated work among  the different AHTEGs dealing with this kind of issues inside CBD and its CPB  (SynBio AHTEC, RA AHTEG and SEC AHTEG) is necessary and will be very helpful  through the discussions  around the subjects dealt with in this forum.

Kind regards,

Caroline
posted on 2015-07-03 19:09 UTC by Ms. Caroline Burgeff, Mexico
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7375]
My name is Jim Thomas, I am Programme Director with ETC Group, a civil society organization that tracks issues in emerging technologies as they impact particularly  biodiversity and marginalized peoples. Once again many thanks to our moderators and to the secretariat for enabling this conversation.

As we have explained in our submission on this topic ETC Group recognizes that there may indeed be a “patchwork” of  existing national, regional and international instruments whose provisions may be relevant to partially regulate aspects of the organisms, components or products derived from Synthetic Biology. However we see significant inadequacies and shortfalls in these and agree with the conclusion reached in CBD technical Series no 82 that there are also gaps which must be addressed in  an appropriate, consistent, comprehensive and adaptive manner. It is clear that such a patchwork does not currently amount to a “comprehensive” framework and would agree with Ms Angela Lozan from Moldova (#7320) that "there is no specific rules and practical procedures in place addressed to synbio and its effects to conservation and sustainable use of biodiversity, including genetic diversity and the benefit sharing aspects” and that "The existent capacities of the countries to ensure safety from Synbio are limited and covered fragmentary by Biosafety (LMOs), Phytosanitary or trade domestic regulations"

To recap we have referred already to some of the specific  inadequacies that need to be addressed in the Cartagena protocol and also the Nagoya protocol if those instruments are to more adequately regulate the organisms, components or products derived from Synthetic Biology techniques. Specifically:

-       The Cartagena protocol should recognise digital transboundary movement of LMOs and their parts.

-       The Cartagena protocol should recognise the notion of a ‘latently viable’ LMO (e.g. a kit set of parts).

-       Advanced Informed Agreement requirements should apply to organisms imported for contained use.

-       Definitions of an LMO under Cartagena should be broadened to also incorporate in vivo modification techniques and techniques that alter or synthesize other parts of genetic systems than just nucleic acids.

-       The term ‘nucleic acids’ should be explicitly clarified to include xenobiological nucleotides.

-       The definition of a Genetic Resource under Nagoya must be clarified to explicitly include digital sequences and the term ‘derivatives’ should be clarified to include re-designed or otherwise altered versions of those sequences as well as to extend to versions of biochemical compounds that may be ‘replaced’ by Syn Bio organisms.

-       The parties might develop a non-exclusive list of techniques and hallmarks commonly regarded as synthetic biology to be used as a reference aid for interpreting ‘modern biotechnology’.


We agree with  further examples of inadequacies such as those given by Dr Christoph Then of Testbiotech (#7334) , Ms Valentina Rastelli (#7353) (regarding lack of a parent organism in risk assessment) and Ms Margret Engalhard of Germany’s reminder 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.” [#7371]
 
Where ETC Group finds a clear and urgent inadequacy (as already noted repeatedly by several respondents - e.g. [#7331], [#7371] , [#7346], [#7347], [#7348] [#7364] [#7373] and many in preceding parts of this forum) is in the lack of capacity of existing instruments to regulate the societal, economic and justice-related impacts of the use of organisms, components or products derived from Synthetic Biology techniques. These include the impact on livelihoods, on traditional economies and customs, on peace, on human rights (including land rights, water rights, farmers rights) and also on the conservation and sustainable use of biodiversity where the impacts are “indirect” impacts on biodiversity.

We would agree with Dr Bass (#7362)  that these "Indirect risks may be even more important than direct ones. “ and believe that to be adequate to the situation we are facing international  governance must evolve away from a simplistic focus on risk and safety to a more complex, nuanced and anticipatory form of technology assessment. Some of the references  provided by Ms Deborah Scott [#7364] move in this direction and we would particularly point to Dr Andy Stirlings’s exhortation to policymakers to “keep it complex”  and not become over-focused on risk alone. While its understandable that national biosafety assessors will focus on the question of how far Syn Bio fits into the existing tools used in their area of expertise we shouldn’t become overly focused on the Cartagena Protocol. We would strongly disagree with the suggestion that determining how far Cartagena applies to Syn Bio is the first order of business for an AHTEG. Questions of definition and the  scope of concerns to be addressed should be established first. Cartagena really only addresses one aspect of the issues to be tackled.

An example of the sort of complexity that biodiversity policymakers will have to increasingly grapple with is the  marketing of SynBio-derived versions of  vanillin, saffron, Stevia artemesia or vetiver, where the competition with the botanical version and false ’ natural' claims could cause significant and deleterious agronomic changes.  Conversely, a synthetic biology company may claim (as they have on this forum)  that the introduction of their synthetic version to the market (e.g. biosynthesized agarwood or sandalwood essence, or algal alternatives to palm oil) may indirectly reduce pressure on biodiversity or put forward other speculative biodiversity claims (as mentioned by Dr Redford). There may be some merit in these claims or there may not and there are presently no fora to assess or validate such biodiversity claims. The lack of such an impartial forum for examining claims around this technology  is another significant inadequacy.

While several treaties, agreements, bodies and instruments could have a mandate to address these issues (e.g. Committee on World Food Security, Human Rights Council, International Court of Justice, UNCTAD), it is notable that the Convention on Biological Diversity itself is uniquely placed and empowered to develop means to regulate this area. Article 8g of the Convention requires parties to “establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.” (Secretariat of the Convention on Biological Diversity (2015). Synthetic biology, Montreal, Technical Series No. 82, 118 pages.) Since this includes the ‘use’ and not only the release of biotech organisms, the CBD by implication already obliges parties to regulate the impacts, including those that result ‘indirectly’ from social, economic and cultural changes.


It would be our proposal that the Convention on Biological Diversity determine how to operationalise this requirement that parties ‘regulate, manage or control’ the risks associated with the use of LMOs resulting from Synthetic Biology techniques, particularly the indirect risks to the conservation and sustainable use of biodiversity, such as economic changes, land use changes, changes to cultures and livelihoods. The convention – through the COP or other bodies – could, for example, develop tools and processes of technology impact assessment to facilitate such regulation with particular consideration for ‘indirect’ socio-economic risks.


Additionally, when it comes to risk since the Cartagena Protocol and other national and regional agreements on biosafety precede the development of Synthetic Biology as a field, and since new techniques are now emerging, it is not clear that the models and risk assessment frameworks developed for organisms produced through recombinant DNA are appropriate for organisms developed through various and different synthetic biology techniques. ETC therefore recommends that a technique-by-technique analysis should be undertaken to consider different requirements in risk assessment of the different techniques (e.g. genome editing, synthetic metabolic engineering, directed evolution, among others) with careful attention to uncertainties, including addressing evidence of unpredictable and unexpected effects arising from the transformation process (e.g. off-target effects or changes in expression).

Additionally, We share the frustration expressed by Mr Legge in [#7352] that a series of industry talking points being re-stated identically  by industry representatives does not help a nuanced and complex conversation going forward nor does it help protect biodiversity or the livelihoods of the poor - only the rather narrow interests of biotechnology companies. lets not let this experience be reproduced in an AHTEG.

Some statements are truly incredible such as Mr Herrera’s astonishing claims  that "ALL forms of biotech are highly regulated throughout the world,” and " 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.”  . What is more worrying however is that  some of the same biotech industry associations that are telling this forum that Syn Bio and other techniques already fit under existing frameworks and so no further work is needed have simultaneously been constructing extensive legal arguments to present to regulators which  claim that new Synthetic Biology techniques, including genome editing techniques, should be excluded from the scope of existing regional and national regulations concerning living modified organisms (see, for example, EuropaBio/New Plant Breeding Techniques Platform, “ Legal Briefing Paper: The regulatory status of plants resulting from New Breeding Technologies” , April 2014   available at http://www.infogm.org/IMG/pdf/nbt-plateform_statut-ogm_avril2014.pdf). If the arguments EuropaBio and others are making are accepted, such legal maneuvering would leave the organisms produced through these highly-novel techniques outside of regulatory scrutiny. This behaviour points up the need to explicitly put such techniques under a clearly agreed legal international framework. Industry needs to get its story straight or stop obstructing governance: Either its new genome-edited and Syn Bio products should be fully regulated as GMO’s (as they claim they are in this forum) or a new framework needs to be developed urgently.

Finally may I encourage the AHTEG when it is formed to bear in mind the larger longer term picture and not get lost in the immediate details. The question of the adequacy of existing arrangements needs to look to the future, to the scope of the emerging Syn Bio industry and how the relationship between society and biotechnology is rapidly changing in light of the new abilities of this platform. Dr Bass referred to this “step change” in the way biotechnology occurs that Syn Bio, genome editing and other new genomic techniques are enabling. The genetic engineering of lifeforms is no longer the artisanal, one-at a time boutique industry it may have been when the existing governance framework on biotechnology was being constructed. it is becoming a multi billion-to-trillion dollar industry, employing thousands of people and equipped with a suite of emerging powerful tools in order to transform thousands-to millions of novel lifeforms in very short timescales  with ambition and investment to simultaneously  reach across food,fuels, chemicals, natural products, mining, conservation, pharmaceuticals, textiles, defense and many other sectors.  To my mind the closest analogy to what is occurring in biotech is what occurred to arts, media and information industries in the late 1990’s as a result of new digital technologies - or perhaps what occurred to diverse agricultural, food, cosmetics and materials industries in the early 20th century as a result of developments in petrochemistry - that is there is an underlying change in the system of production enabled by ‘digital biology’ that will have far reaching implications we cannot yet glimpse.

To confidently assume at this juncture  that old governance systems framed before that change will be truly ‘adequate’ is potentially as wrong-headed as having assuming 30 years ago that laws framed to regulate typewriters would be adequate to govern computers, cellphones, digital media and the internet. The CBD has a historic opportunity, through this discussion to evolve governance and oversight of biotechnology to keep up with or move ahead of industrial developments. Why would we squander that opportunity?

Sincerely

Jim Thomas, ETC Group.
posted on 2015-07-03 21:24 UTC by Mr. Jim Thomas, ETC Group
This is a reply to 7361 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7377]
Dear All,

A time to thank the Secretariat and moderation, it has been a very interesting to read many publications that enrich the debates experience and we see many similarities in thoughts

The existing regulatory frameworks focus on risk assessment, there is a lack of national, regional and international instruments to regulate organisms, components or products derived from synthetic biology techniques, at the same time this particular regulatory framework must address reduction or loss of biological diversity, socio-economic effects and the question of liability and redress.

Best regards,  

Sorka Copa Romero
Bolivia (Plurinational of State)
posted on 2015-07-03 22:49 UTC by Ms. Sorka Jannet Copa Romero, Bolivia (Plurinational State of)
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7381]
Dear forum participants,

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 contribute my thoughts to this forum.  The wide diversity of opinions expressed throughout this topic will be of great help to the upcoming AHTEG.

Jaco Westra (#7350) points out that the challenge for the AHTEG is not to determine whether the current framework is “comprehensive”, but to get “a clearer picture” of the “patchwork” and to “identify if and where additional measures will be called for.”

Several others have suggested ways to evaluate that patchwork.  Our moderator, Maria Torres, in an early posting (#7323) pointed out the challenge is “to define an appropriate framework”.  Shortly thereafter, Mariska Wouters (#7325) presents the concept of “an adequate framework”, and later on Jim Thomas (#7375) helpfully adds the concept of “adaptive”. 

The variety of postings to this forum make clear that many of us view the potential impacts of synthetic biology quite differently, thus our perspectives on what is “adequate” and “appropriate” will differ.  This is true for both risks and potential benefits.  Maria Mercedes Roca (#7369) points out that the emphasis on risk varies by country, and in her view, is preventing potential benefits in the least developed nations. 

Which leaves the third concept: “adaptive”. Mike Paton (#7273), under Topic 4, discussed the importance of adaptive governance for rapidly changing technologies such as synthetic biology, pointing out the role of the UK’s Synthetic Biology Leadership Group.  In an earlier post (#7365, Topic 6), I pointed out that the US Government recently announced it will be periodically review US regulations to be prepared for future products of biotechnology. 

As Jim Louter (#7339) and many others have pointed out, today’s synthetic biology is “biotechnology 2.0”.  Whether one views that the current framework is “appropriate and adequate” for synthetic biology, probably has more to do with one’s view whether it is appropriate and adequate for “biotechnology 1.0”.   In my view, the key tasks that the AHTEG will face are to identify the patches that may need to be made to current international frameworks, but more importantly, determine whether the current frameworks need to be more “adaptive”  to the inevitable change of technology.

Sincerely,
Bob Friedman
posted on 2015-07-04 23:01 UTC by Mr. Robert Friedman, J. Craig Venter Institute
This is a reply to 7381 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7383]
Dear all,

Thank you once again for the opportunity and coordination. I recognize the enormous work that the SCBD and other participants have put forward to the issue of synthetic biology under the CBD discussions.

The existing arrangements may not constitute a comprehensive framework to address impacts synthetic biology and further guidance should be developed.

As an example, the assessment of potential threats of significant reduction or loss of biological diversity might, for instance, require proper sampling, detection and identification of synbio products in the field. It is my experience from the Network of Laboratories for the Detection and Identification of Living Modified Organisms that we have not move much forward in regards to LMOs. All available validated methods are based on DNA and protein detection, and RNA species are still not covered. On the other hand, LMOs with modified small RNA contend are already on the market.

Also, many of the existing RA guidance are based on a comparative analysis. What are the proper comparators? What are the synergies of stacking several transgenes or even synthetic chromosomes?

I echo those who have pointed to the existing range of uncertainties of synbio applications and the lack of specific standards or guidelines agreed to estimate their potential impacts. As well as to the existent capacity of countries to ensure the safe use of synbio which is covered by fragmented biosafety (LMOs), phytosanitary or other trade domestic regulations.

Finally, I would again like to support the coordinated work among SynBio AHTEG, RA AHTEG and SEC AHTEG for the best development of potential synbio risk issues.

Best regards,

Sarah Agapito
posted on 2015-07-05 01:02 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7384]
Dear Participants,

I am Felicity Keiper from Bayer CropScience, also representing CropLife International. Thank you once again for the opportunity to contribute to the discussion.

The existing arrangements for assessing the potential impacts of living modified organisms, as products or components of synthetic biology, on biological diversity consist primarily of the Convention and Cartagena Protocol. These provide a framework with broad application to biotechnology, the types of genetic materials  used, and the LMOs created. This is demonstrated by the many participants who consider that their national LMO frameworks cover synthetic biology (Topic 6 #7322, #7324, #7332, #7338, #7351; Topic 7 #7325, #7339, #7343, #7355), and this is consistent with industry experience with synthetic biology applications (Topic 7 #7336). According to the principles of Annex III of the Protocol, the potential impacts of LMOs on biological diversity can be adequately examined by taking a case-by-case approach to risk assessment that is focussed on the characteristics of the LMO and its intended use, and not the technologies used. Other international frameworks may also overlap as detailed in CBD Technical Series No. 82 and by participants (e.g. Topic 6 #7341; Topic 7 #7342).

Where the product/component of synthetic biology is not an LMO, the Convention remains applicable in that it imposes a broad obligation on Parties to avoid or minimise significant adverse effects on biological diversity (Article 14(a)). In addition, such products/components will be regulated by the applicable industry sector, e.g. food, pharmaceutical, or chemical. Many participants also consider that their national regimes in these industry sectors cover synthetic biology (Topic 6 #7322, #7324, #7338, #7351; Topic 7 #7325, #7343). In the context of impacts on biological diversity, there are many international, regional and bilateral regimes for regulating chemical use in order to protect the environment.

Given the vast range of potential applications and products of synthetic biology, it does not make sense to create a new specific regime. This would duplicate the broadly applicable Cartagena Protocol and be restricted to a sub-set of biotechnology, and likely to quickly become out-dated and lose relevance. It would also duplicate other well-established sectoral regimes applicable to non-LMOs. Many participants have stated that their national regimes are adequately comprehensive for synthetic biology, while others report deficiencies. A new regime for synthetic biology will not overcome deficiencies in national regimes where there are already international frameworks that provide an adequate foundation, or improve compliance with these at the national level. Rather, the obstacle may be an absence of defined environmental protection goals at the national level, as indicated by the variable degrees of compliance with the Convention requirement to develop and adopt an updated National Biodiversity Strategies and Action Plans (NBSAPs) in accordance with Aichi Target 17 (https://www.cbd.int/nbsap/default.shtml). In this discussion it should also be remembered that impacts on biological diversity may be positive (see Topic 7 #7337), and not automatically negative and requiring over-cautious regulation. This is recognized in the Convention, which considers technology essential for attaining its objectives.

Best regards,

Felicity Keiper
posted on 2015-07-05 08:13 UTC by Ms. Felicity Keiper, Bayer CropScience
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7386]
Dear forum participants,

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

We thank the forum members for such a lively debate and agree with the proposal that the synthetic biology, risk assessment and socio-economic AHTEGs should work together, supported by the sharing of best practice between countries discussed in topic 6.

Additionally, we thank Mr. Kent (#7337) for highlighting a small subset of the potential positive impacts that synthetic biology could have on biological diversity and Mr Paton (#7367) for highlighting that the current EU regulatory approach prevents us from accessing the positive impacts on biological diversity that could be provided by synthetic biology.

Risks associated with applications should be judged on a case-by-case basis, alongside the risks of inactivity and the risks provided by any alternatives. Therefore, while we believe that the current EU regulatory framework is adequate to cover the risks associated with synthetic biology, we support the development of a more ‘adaptive’ framework with a broader reach to allow better benefit sharing.

Many thanks,
Patrick and Louise
posted on 2015-07-05 14:32 UTC by Dr. Patrick RUDELSHEIM, Belgium
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7389]
Dear all
Under all existing treaties, no specific guidance exists to  address all potential negative effects associated with the application of synthetic biology techniques. furthermore, not all the components and products resulting from synthetic biology techniques fall within the scope of those treaties including the Cartagena Protocol. it is also important to mention that  discussions are also needed when the advances in synthetic biology lead to the emergence of new gaps.
A very likely situation regarding the nature of this branch of science.
O.A.El-Kawy
posted on 2015-07-05 17:45 UTC by Mr. Ossama AbdelKawy, Mauritania
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7390]
Dear Forum Participants, one more time my thanks to moderators,  the Secretariat and to this remarkable group of experts in different areas of the same issue. 

A clarification note
To whom it might concern:

What I really meant in my post [#7327] on Topic 7 was that the current Annex III of the CP and related documents (Training Manual on Risk Assessment of Living Modified Organisms in the context of the Cartagena Protocol on Biosafety and the modules explanations) should be complemented in order to reach the state of the art in risk assessment and management, mainly in the planning phase, when possible, establishing the appropriate comparator(s) which is an often lack in SB organism and the moment where starts working in facilities at the stage of contained use first of all focus on laboratory acquired infections and also in an environmental release (accidental or intentional) during research raising other issues.
Risk assessment practices in various countries in the CP framework are also applicable (for instance: Biosafety Technical Series no. 2 Summary and Comparative Analysis of Nine National Approaches to Ecological Risk Assessment of Living Modified Organisms in the Context of the Cartagena Protocol on Biosafety, Annex III)

“If reasonable precautions are to be taken against laboratory-acquired infections it is necessary to assess realistically the hazards that might be imposed on the laboratory worker and on the community during and as a result of work with any particular micro-organisms.”  Fleming DO. 2006. Risk Assessment of Synthetic Genomics: A Biosafety and Biosecurity Perspective. In: Working Papers for Synthetic Genomics: Risks and Benefits for Science and Society, pp. 105-164. Garfinkel MS, Endy D, Epstein GL, Friedman RM, editors. 2007.

I think that we are aware of the current and potential positive impacts of SB and the negative as well. The point is not to put a ban on SB but  to reach an appropriate control, looking at vulnerabilities and gaps when facing hazards to reduce risk, to close the gaps at appropriate level of risk management. We have a responsibility with the mankind in the CP and the CBD framework let’s do it.

Respectfully,
Dr Regalado

Cuban National Center for Biosafety. Ministry of Science, Technology and Environment
posted on 2015-07-05 17:54 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7375 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7391]
Dear participants and moderator, thanks for the opportunity to provide comments. 

I would like to draw the attention to #7375 posted by Jim Thomas, in my view very interesting and useful with a holistic approach and as part of the different shades of opinions looking at the present and to the near and long term future as well.

Sincerely,
Dr L. Regalado

Cuban National Center for Biosafety. Ministry of Science, Technology and Environment
posted on 2015-07-05 18:02 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7392]
I am Joyce Tait, Director of the Innogen Institute in the University of Edinburgh. I am also a member of the UK Synthetic Biology Leadership Council and Chair of its Governance Subgroup. However, the opinions expressed here are my own, based on academic research on the complex interactions involved in supporting and regulating innovative developments in life sciences, including GM crops since the 1980s and, more recently, synthetic biology.
I agree with the points made in this and earlier discussions that the regulatory systems we have in place today for contained use and deliberate release will be adequate to deal with any new challenges raised by synthetic biology, or could be adapted to do so without the need for a new regulatory approach. However, no regulatory system is perfect and, by incorporating a better understanding of governance/innovation interactions, these discussions could provide an opportunity to adapt current regulatory systems (see Mike Paton, Topic 4, #7273, and Bob Friedman, #7381) to increase the opportunities for synthetic biology to meet societal needs and desires, including improved conservation of biological diversity. The current provisions of the CBD and its protocols are rather blunt instruments, well-meaning in the context of protecting bio-diversity but seriously inhibiting of innovation that could make a positive contribution towards that protection.
It is now well understood that the more time-consuming, expensive and demanding the regulatory system, the greater the dominance of the innovation system by large multinational companies as only they have the necessary resources to meet this challenge. Thus the dominant role of multinationals in developing GM crops and potentially also synthetic biology, to the regret of civil society groups, is a direct result of the regulatory systems they themselves have been so influential in creating and which they are seeking to perpetuate or amplify. In the health-related context, regulators are now well aware of the need for smarter, more adaptive approaches to regulation and are making changes that are having a dramatic impact on the cost of development of some new classes of drugs that meet specific societal needs (e.g. novel antimicrobials). In the context of biodiversity, smarter, more adaptive regulatory systems would enable small companies in developed and developing economies to produce niche applications for the smaller markets that are not attractive to multinationals but would be viable for a small company. These could, for example, deliver benefits to peasant farmers by enabling them to farm in more sustainable ways, or perhaps to grow a broader range of crops to meet local needs. Such innovations will be impossible unless our current regulatory systems are made more adaptive.
Jim Thomas (#7375) draws attention to the transformative potential of synthetic biology and makes a useful comparison with the development of information and communication technologies in the 1980s and 90s. The available evidence would suggest that if a regulatory system similar to that of the CBD and its protocols had been in operation for these technologies, the flourishing of innovation potential that we have experienced would never have happened. This is the danger faced by developers of synthetic biology if we are not able to adapt our current regulatory systems to be smarter in supporting innovations that are safe and meet societal needs and desires.
To give another innovation/regulation related example, the discussion on defining synthetic biology was inconclusive, but strongly focused on the need for such a definition. However, some participants pointed out that the robust type of definition that is required to support process-based regulation could be inhibiting of innovation by driving it towards or away from particular applications, and the importance of such biases in the early stages of development of a new technology should not be underestimated. The case for having such a technology-driving definition is considerably weakened if the regulatory system is product based (as in Canada and the USA) rather than process based (as for Europe and the CBD), as was advocated by many participants in earlier discussions.
There were frequent references in earlier discussions to the case-by-case regulatory systems currently in operation with the implication that this should be the basis for all future regulation. One could, on the other hand, point out that an adaptive regulatory system is one that would build on regulatory experience over the years and, for example, move towards a class-by-class approach as information on the behaviour of specific types of organism or product accumulates. Given the expected range and scale of applications from synthetic biology, maintaining a case-by-case approach indiscriminately may become unworkable.
Another important strand of discussion under previous topics was the extent to which the products of synthetic biology might have the unintended result of depriving small scale specialist farmers of their living, with knock-on environmental disturbances. One way of dealing with such issues is by stopping development of the technology, as advocated by several participants in these discussions. However, there are other smarter options that will allow a broader range of technologies to be developed, meeting a broader range of societal needs in numerous countries, much as has happened in the information and communication technologies. Relevant options would include: straightforward environmental protection regulation (also a potential source of jobs); government policies to support production of particular types of product; government subsidies for particular production systems that deliver societal benefits (as happens in many places for organic farming). Such approaches would enable a country to experience the broader economic and other societal benefits that might arise from synthetic biology while at the same protecting biodiversity.
The overall point being made here is that, by better understanding how innovation systems and regulatory systems interact with one another, it is possible to deliver an outcome that: (i) allows greater flexibility for a broader range of companies to develop novel, useful products that are safe; (ii) allows countries to benefit from a broader range of new products that meet societal needs and can improve economic prosperity; and (iii) at the same time protects and even improves on current levels of biodiversity.
The above comments are a selection of insights based on a major programme of academic research, further details of which are on the website of the Innogen Institute (http://www.innogen.ac.uk).
Joyce Tait, University of Edinburgh
posted on 2015-07-05 18:03 UTC by Ms. Joyce Tait, University of Edinburgh
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7395]
Dear all participants,

I follow the discussion and I read very interesting proposals as needed coordinated work between SynBio AHTEC, RA AHTEG and SEC AHTEG that I agree with this.

I would like to suggest that it is needed the existing arrangements work in synergy in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity; considering a new international agreement on Synthetic Biology (SB).

I suggest that AHTEG on Synthetic Biology will work on scope synthetic biology (components and products resulting from synthetic biology techniques do not fall within the scope of a Cartagena Protocol), risks assessment, monitoring the effects on components of biological diversity and the gaps on capacity in the countries.

Best regards,

Dr. Marina Rosales Benites de Franco
Professor Federico Villarreal National University
IUCN CEM Member:Commission on Ecosystem Management
posted on 2015-07-05 20:15 UTC by Ms. Marina Rosales Benites de Franco, IUCN
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7397]
My name is Dr. Todd Kuiken and I am the principle investigator of the Synthetic Biology Project at the Woodrow Wilson Center. I am also a founding member of iGEM’s biosafety/biosecurity committee and the chairperson of the Human Practices requirements of the competition. I would like to frame my comments for Topic 7 in relation to my work with iGEM as I feel it is a real life example of one model of international governance of synthetic biology. I am not representing iGEM in this capacity and my comments do not necessarily reflect the views of iGEM.

iGEM (http://igem.org/Main_Page) started as an undergraduate synthetic biology competition at MIT in 2004.  Since then it has grown into a global competition that includes high school teams and community laboratories from both developed and developing nations. This year’s competition has over 280 teams from every continent on the planet (minus Antarctica).

The biosafety committee was formed in part to do exactly what the CBD is currently contemplating, to “address impacts of organisms, components and products resulting from synthetic biology”. As the competition grew in size, both in numbers and geographically, we found it increasingly difficult to monitor all of the teams which were operating under very different regulatory, biosafety and biosecurity regimes.  Based on the numerous national laws governing research, including the transboundary movement of genetic material, we developed a system which, in our view, protects both the students involved in the competition and addresses the potential risks related to the research being conducted (http://2015.igem.org/Safety).

Beyond just ensuring safety the biosafety committee designed its safety protocols to act as an educational tool in order to train the students (next generation scientists) how to better design their experiments in order to address potential safety and security concerns.  In addition, the iGEM protocols serve as a fore ray into the student’s professors, as they must sign off on the student’s safety forms. While many of the professors understand the safety risks of research, not all understand the potential international biosafety/security rules that accompany shipping of biological parts. By requiring the professor to take responsibility over the safety form, the goal is that we are reaching both the students and any potential professor who is unaware of the safety/security issues. 

Human practices (http://igem.org/Human_Practices) is the other major component of the iGEM competition that teams are required to participate in. iGEM views this as an integral component of a team’s project and has developed judging criteria in order for a team to win medals.  iGEM projects involve important questions beyond the bench relating to (but not limited to) ethics, sustainability, social justice, safety, security, environmental impact or intellectual property rights. Teams must demonstrate how they investigated and addressed one or more of these issues and fully integrate it into the design, execution and presentation of their project. Teams need to document how their project evolved based on the information acquired from these activities.

Over the years we have seen the quality of team’s human practices work improve to the point where it is not just fully integrated into their projects but teams are now seeking out members that can focus solely on human practices.  Like the safety work, iGEM is using the human practices requirements as an opportunity to train the next generation of scientist to incorporate these issues into the design of their experiments and eventual applications.
One critical aspect in order for this model to work outside of iGEM is for governments and/or international bodies to require this type of reflection and documentation and develop its procedures so it becomes part of the culture of research.

I would encourage the AHTEG to examine the work within iGEM as a potential model for developing governance systems in order to meet the requirements of the CBD as it relates to synthetic biology.

Kindest regards,
Todd Kuiken, Ph.D.
posted on 2015-07-05 21:06 UTC by Mr. Todd Kuiken, North Carolina State University
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7398]
Topic 7:  Degree to which existing arrangements constitute a comprehensive framework to address threats to biodiversity from SB organisms, components or products

My name is Frederic Bass.  I am a physician and epidemiologist who worked in tobacco addiction for 45 years.   Nearly all public health authorities ignored the tobacco epidemic during the first decades of my work.  Finally it was seen to be the #1 cause of death in North America and it became a major public health priority.  I serve now as an associate member of the Canadian Friends Service Committee, focusing on synthetic biology.

I thank the Secretariat and Moderator for this final discussion and your openness to a range of viewpoints.  We share a profound responsibility and opportunity. 

As Scott noted [#7364], the Nuffield Council on Bioethics identifies three challenges that we face in synthetic biology:  uncertainty (lack of knowledge about the range of potential outcomes and their probabilities); ambiguity (lack of agreement about the implications and relative importance of possible outcomes); and transformative potential (capacity of biotechnology to transform/displace social relations and means of production).  CB-ts 82 pages 111-2 support these Nuffield report findings.

My three comments:
1.  Nature sets limits.  The CBD must recognize the world’s ecological emergency to be the crisis it is.  Existing arrangements that apply to synthetic biology fail to recognize that our species is well down the road to ecological and thus societal collapse.  A comprehensive framework for synthetic biology must recognize limits. 
Things change.  Coal that gave us more energy and the internal combustion engine that gave us more mobility together have also generated enough CO2 to produce climate change and major loss of biodiversity.  With or without synthetic biology the laws of nature apply, human faith in technology notwithstanding. 

2.  Controlling loss of biodiversity requires assessment, monitoring and intervention of the decline in biodiversity on an international, as well as a national, level.  Existing arrangements for public management of synthetic biology do not assure that this will happen.  Assessment of biodiversity loss should not only count disappearing species but also track underlying causes such as overconsumption of natural resources, an economic system that promotes overconsumption, an unjust distribution of benefits that motivates some to destroy biodiversity and the absence of democratically-derived limits on resource consumption.  Monitoring must, per the CBD definition of biodiversity, include regular assessment of the health of ecosystems, though to measure this is a very challenging task.  In terms of intervention, the need to collate existing national protocols has been noted.  CBD could provide a model set of guidelines for national regulation of synthetic biology.  A protocol for international intervention is also needed.  As part of monitoring and intervention at the international level, we need an Ecological Intelligence Service, analogous to the US Center for Disease Control’s Epidemic Intelligence Service that helps, on short notice, to assess and respond to disease outbreaks around the world.

3.  More than experts required.  Last week in Nature 522: 413-4, Sarewitz contributed "Science Can’t Solve It."  The gist of the article is that weighing the benefits and risks of biotechnology is best done by democratically-chosen representatives of the public.  He notes, “The idea that the risks, benefits and ethical challenges of these emerging technologies are something to be decided by experts is wrongheaded, futile and self-defeating.  It misunderstands the role of science in public discussions about technological risk.  It seriously underestimates the democratic sources of science’s vitality and the capacities of democratic deliberation.”  “Risk,” Sarewitz says, “is more a political and cultural phenomenon than it is a technical one.”  Furthermore, scientists are not elected.  He notes one model which might be considered by AHTEG, the World Wide Views alliance, formed in 2009 by the Danish Board of Technology.  WWV convenes 100 diverse citizens at sites around the world in groups of 5-8 to discuss a set of questions and then vote on policy choices.  The topics have ranged from climate to biodiversity.  He concludes, “Values, governance regimes and research agendas can co-evolve in response to such knowledge.  Democracy and science will both be better off.”

I wish to thank all my discussion-mates for their interesting and challenging contributions.
posted on 2015-07-05 21:10 UTC by Dr Frederic Bass, self-employed
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7399]
Dear Maria, 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.

As this is a last online-discussion round I would like resume some thoughts that are from my point of view important for the work of the AHTEG.

As synthetic biology is a multilayered and fluid field of research it is important not to focus on an irremovable definition of synthetic biology in the beginning. This would bring along the risk of being too brought or narrow respectively. And - what is even more important - definition might be exploited to push through different political agendas instead of reflecting the realities of the research field. Therefore a list with new features (as for example the loss of familiarity) that synthetic biology or some subfields bring along and that could be relevant to biodiversity might be a good way out of this dilemma. A second argument for such a list of new features prior to a rigid definition of synthetic biology is that it remains flexible and able to adapt to new scientific developments. Both the online-discussion and the CBD Technical Series No. 82 are valuable and important sources for the preparation of a list of new features. This list can also serve as a good basis for identification of aspects of synthetic biology that are already adequately regulated and which are not. The online discussion has given numerous examples for both cases.

Also I think that a mutual information exchange with the AHTEG on Risk Assessment could become valuable help for the work of the AHTEG.

Last but not least I would like to thank the organizers to have realized this important discussion on synthetic biology that is and will surely be of importance for biodiversity.

With best regards,
Margret
posted on 2015-07-05 21:11 UTC by Ms. Margret Engelhard, Germany
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7402]
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 on-line 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 additional 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 22:41 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7403]
Dear Moderator,
In addition to my previous comments on Topic 7, I would like to make these suggestions for AHTEG membership:
a biologist, expert in evaluating introduced species,
an evolutionary biologist,
a social scientist,
and two or more indigenous persons experienced and concerned with matters of biodiversity.
Fred Bass
posted on 2015-07-05 23:30 UTC by Dr Frederic Bass, self-employed
This is a reply to 7312 RE: Opening of Discussion:Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity [#7408]
POSTED ON BEHALF OF YONGBO LIU
Please Note: this message arrived at the Secretariat before the closing of the discussion.
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Dear Participants of the Online Forum on Synthetic Biology,
Greetings from China.
My name is Yongbo Liu, from Chinese Research Academy of Environmental Sciences. Thank you once again for the opportunity and coordination.
For this topic 7 about the “Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity”, there are also lots of excellent discussions, like Jim Thomas in  [#7375]. The existing arrangements may not yet constitute a comprehensive framework to address these impacts.
In my view, the assessment of potential threats of significant reduction or loss of biological diversity might be the next step because it mainly involves in the existence of synbio products in the natural ecosystems. As Sarah Agapito in [#7383] pointed out that this requires proper sampling, detection and identification of synbio products in the field. The whole biosafety assessment of synbio products is the fundamentality before environmental release. Therefore, the first step is to strictly prevent the escape of synbio products from Laboratories through constructing adequate “hardware” and “software” measures, including emergency responses to the unexpected occurrence of escapes.
Finally, I support the international coordinated work among organizations as well.

Greetings to all.

Cheers,
Yongbo Liu
posted on 2015-07-06 17:01 UTC by Dina Abdelhakim, SCBD