Dear Friends and Colleagues CBD Parties urged to regulate synthetic biology The UN Convention on Biological Diversity (CBD) held its 12th Conference of the Parties (COP 12) from 6-17 October 2015, in Pyeongchang, Republic of Korea. In a significant decision on synthetic biology, COP 12 urged Parties to take a precautionary approach, and to establish effective measures to regulate the environmental release of any organisms, components or products resulting from synthetic biology techniques. The decision also urged Parties to approve organisms resulting from synthetic biology techniques for field trials only after appropriate risk assessments have been carried out, and called for synthetic biology organisms, components and products to be subject to scientific assessments that consider risks to conservation and sustainable use of biodiversity as well as human health, food security and socio-economic considerations. Such risk assessments should be done with, where appropriate, the full participation of indigenous and local communities. COP 12 also established a process to carry out work on synthetic biology, including setting up an Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology to, among others, determine if living modified organisms (LMOs) derived from synthetic biology fall under the scope of the Cartagena Protocol on Biosafety, and to identify if other national, regional and/or international instruments provide adequate regulation and if the existing arrangements constitute a comprehensive framework to address impacts. The AHTEG is also asked to, building on the work on risk assessment and risk management undertaken by the Cartagena Protocol, compile information on best practices on risk assessment and monitoring regimes, so that organisms, components and products from synthetic biology techniques may be regulated appropriately. Please find below an article reporting on the issue (Item 1) and the draft decision (Item 2). With best wishes Third World Network 131 Jalan Macalister 10400 Penang Malaysia
Regulate synthetic biology now: 194 countries
SynBioWatch, 20 Oct 2014
* SynBio industry’s wild west days are numbered
In a unanimous decision of 194 countries, the United Nation’s Convention on Biological Diversity (CBD) today formally urged nation states to regulate synthetic biology (SynBio), a new extreme form of genetic engineering. The landmark decision follows ten days of hard-fought negotiations between developing countries and a small group of wealthy biotech-friendly economies. Until now, synthetic organisms have been developed and commercialized without international regulations; increasing numbers of synthetically-derived products are making their way to market.
The CBD’s decision is regarded as a “starting signal” for governments to begin establishing formal oversight for this exploding and controversial field.
“Synthetic Biology has been like the wild west: a risky technology frontier with little oversight or regulation,” Jim Thomas of ETC Group explained from CBD negotiations in Korea. “At last the UN is laying down the law.”
“This international decision is very clear,” Thomas added. “Not only do countries now have to set up the means to regulate synthetic biology, but those regulations need to be based on precaution and not harming the environment.”
“The good news is that precaution won the day.”
This decision comes at a critical time. The SynBio industry is bringing some of its first products to market, including a vanilla flavour produced by synthetically modified yeast and specialized oils used in soaps and detergents derived from synthetically modified algae. In December, bay area SynBio firm Glowing Plants Inc. intends to release synthetically-engineered glow-in-the-dark plants to 6,000 recipients without government oversight. The United States is not a signatory to the CBD, making it one of only three countries that will not be formally bound by this decision (the other 2 are Andorra and the Holy See).
Compared to conventional genetic engineering, synthetic biology poses serious risks to the environment, biodiversity and health as well as to the cultures and livelihoods of Indigenous peoples and local communities. Scientists warn that modified algae and yeast could have unpredictable effects if they escape. New applications could also disrupt the behaviour of plants, insects and potentially whole ecosystems. For example, dsRNA crop sprays  disrupt the action of genes, which may kill targeted pest, but will also affect other organisms in unpredictable ways by silencing genes.
“The multibillion-dollar SynBio industry has been slipping untested ingredients into food, cosmetics and soaps; they are even preparing to release synthetically modified organisms into the environment,” said Dana Perls of Friends of the Earth-U.S. “This decision is a clear signal that synthetic biology urgently needs to be assessed and regulated.
“Governments need to step in to do that.”
Many of the diplomats negotiating at the UN Convention had instructions to establish a complete moratorium on the release of synthetically modified organisms. However, they faced stiff opposition from a small group of wealthy countries with strong biotech industries, particularly Brazil, Canada, New Zealand, Australia and the UK.
After a week of negotiations, battle lines were drawn between the pro-SynBio states on one side and African, Asian, Caribbean and Latin American countries on the other side. Notable among the latter group were: Malaysia, Bolivia, Philippines, Saint Lucia Antigua, Ethiopia, Timor Leste and Egypt.
Global South representatives raised concerns that synthetic biology products intended to replace agricultural commodities could devastate their economies and degrade biodiversity. Many delegates were also concerned that synthetically modified organisms could create biosafety risks – e.g. the possibility of synthetic algae escaping into waterways, producing a solar-powered oil spill.
A network of international organizations including Friends of the Earth, ETC Group, Econexus and the Federation of German Scientists had been closely monitoring the negotiations and providing input for over 4 years. Civil society groups first raised the topic of synthetic biology at the CBD in 2010.
“It was good to see delegates of the South stand up for the interests of their farmers, peasants and biodiversity here in Pyeongchang,” said Neth Dano, Asia Director of ETC Group. “This is not the moratorium many of us wanted, but it’s a good step in the right direction.”
“Synthetic biology involves many novel, experimental, little understood techniques and outcomes, and this greatly increases the risks involved to the environment, human health, food security and livelihoods,” said Helena Paul of EcoNexus. “Our technical cleverness tends to blind us to our ignorance; the UK wishes to play a leading role in synthetic biology and does not seem to want precaution to stand in the way, so this COP decision is a helpful corrective to that dangerous policy.”
What’s in the CBD decision?
The CBD’s three-page decision outlines its recommendations for member countries’ approaches to synthetic biology. The CBD urges all member countries to:
* Follow a precautionary approach to synthetic biology.
* Set up systems to regulate the environmental release of any synthetic biology organisms or products. These regulations must ensure that activities in one country cannot harm the environment of another. (Article 3 of the CBD)
* Ensure that no synthetic biology organisms are released for field trials without a process of formal prior risk assessment.
* Submit synthetic biology organisms, components and products to scientific assessments that consider risks to conservation and sustainable use of biodiversity as well as human health, food security and socio-economic considerations.
* Encourage research funds to assess the safety of synthetic biology as well the socio-economic impacts of the technology.
* Support developing countries to develop their capacity to assess synthetic biology.
The decision also:
* Establishes an ongoing process within the Convention on Biological Diversity, including an expert group which will establish a definition of synthetic biology and identify whether existing governance arrangements are adequate.
* Invites other UN bodies to consider the issue of synthetic biology as it relates to their mandates.
The full text of the decision agreed by COP 12 of the CBD is available here: http://www.cbd.int/doc/meetings/cop/cop-12/insession/cop-12-L-24-en.pdf
17 October 2014
CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITY
Pyeongchang, Republic of Korea, 6-17 October 2014
Agenda item 24
NEW AND EMERGING ISSUES: SYNTHETIC BIOLOGY
Draft decision submitted by the Chair of Working Group II
The Conference of the Parties,
Reaffirming paragraph 4 of decision XI/11, “Recognizing the development of technologies associated with synthetic life, cells or genomes, and the scientific uncertainties of their potential impact on the conservation and sustainable use of biological diversity, urges Parties and invites other Governments to take a precautionary approach, in accordance with the preamble of the Convention and with Article 14, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations”,
Noting decision BS-VII/12, of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, recommending a coordinated approach on the issue of synthetic biology taking into account that the provisions of the Cartagena Protocol may also apply to living organisms resulting from synthetic biology,
1. Takes note of the conclusions of the Subsidiary Body on Scientific, Technical and Technological Advice at its eighteenth meeting, as contained in paragraph 1 of recommendation XVIII/7, recognizes that this issue is of relevance to the Convention and concludes that there is currently insufficient information available to finalize an analysis, using the criteria set out in paragraph 12 of decision IX/29, to decide whether or not this is a new and emerging issue related to conservation and sustainable use of biological diversity;
2. Awaits the completion of a robust analysis using the criteria in paragraph12 of decision IX/29;
3. Urges Parties and invites other Governments, to take a precautionary approach in accordance with paragraph 4 of decision XI/11, and:
(a) To establish, or have in place, effective risk assessment and management procedures and/or regulatory systems to regulate environmental release of any organisms, components or products resulting from synthetic biology techniques, consistent with Article 3 of the Convention on Biological Diversity;
(c) To approve organisms resulting from synthetic biology techniques for field trials only after appropriate risk assessments have been carried out in accordance with national, regional and/or international frameworks, as appropriate;
(d) To carry out scientific assessments concerning organisms, components and products resulting from synthetic biology techniques with regard to potential effects on the conservation and sustainable use of biodiversity, taking into account risks to human health and addressing, as appropriate, and according to national and/or regional legislation, other issues such as food security and socioeconomic considerations with, where appropriate, the full participation of indigenous and local communities;
(e) To encourage the provision of funding for research into synthetic biology risk assessment methodologies and into the positive and negative impacts of synthetic biology on the conservation and sustainable use of biodiversity, and to promote interdisciplinary research that includes related socioeconomic considerations; and
(f) To cooperate in the development and/or strengthening of human resources and institutional capacities, including methodologies for risk assessments in synthetic biology and its potential impacts on biodiversity, in developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition, including through existing global, regional and national institutions and organizations and, as appropriate, by facilitating civil society involvement. The needs of developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition, for: financial resources; access to and transfer of technology consistent with Article 16 of the Convention; establishing or strengthening regulatory frameworks; and the management of risks related to the release of organisms, components and products resulting from synthetic biology techniques, should be taken fully into account in this regard;
4. Decides, subject to the availability of resources, to establish an Ad Hoc Technical Expert Group, with terms of reference as in the annex to the present decision, to be convened after the Executive Secretary has completed the requests in paragraph 7 below;
5. Invites Parties, other Governments, relevant organizations and stakeholders to submit information to the Executive Secretary relevant to the work of the Ad Hoc Technical Expert Group, as established in the present decision, as well as on measures undertaken in accordance with paragraph 3 above, including identifying needs for guidance;
6. Invites Parties, other Governments, relevant international organizations, indigenous and local communities and relevant stakeholders to continue to provide further information to the Executive Secretary in response to decision XI/11 paragraph 3 (a);
7. Requests the Executive Secretary, subject to the availability of financial resources, to:
(a) Make available the information reported in accordance with paragraphs 5 and 6 above through the clearing-house mechanism of the Convention and other means;
(b) To convene a moderated open-ended1 online forum to support the work of the Ad Hoc Technical Expert Group established in paragraph 4 (above) in meeting its terms of reference;
(c) To prepare an updated report on the work specified in paragraphs 3(a), 3(b) and 3(c) of decision XI/11, taking into account information submitted in paragraphs 5 and 6 above and a synthesis of the outcomes of the process mentioned in paragraph 7(b) and to submit these for consideration by the Ad Hoc Technical Expert Group;
(d) To submit for consideration by a meeting of the Subsidiary Body on Scientific, Technical and Technological Advice prior to the thirteenth meeting of the Conference of the Parties, the peer reviewed reports of the outcomes of the process mentioned in paragraph 7(b) and 7(c) above;
8. Invites relevant organizations, including relevant United Nations organizations and bodies, to consider the possible implications of synthetic biology as it relates to their mandates.
 The open-ended online forum will be open to all interested participants and continue for a finite period of time.
TERMS OF REFERENCE FOR THE AD HOC TECHNICAL EXPERT GROUP ON SYNTHETIC BIOLOGY
The Ad Hoc Technical Expert Group will include balanced representation of Parties from all regions and include representation of indigenous and local communities and all relevant stakeholders, including other Governments, with knowledge of the Convention and its Protocols,2 and will report on its work to a meeting of the Subsidiary Body on Scientific, Technical and Technological Advice prior to the thirteenth meeting of the Conference of the Parties.
The Ad Hoc Technical Expert Group will:
(a) Take note of the exchange views on how to address the relationship between synthetic biology and biological diversity;
(b) Identify the similarities and differences between living modified organisms (as defined in the Cartagena Protocol) and organisms, components and products of synthetic biology techniques to determine if living modified organisms derived from synthetic biology fall under the scope of the Cartagena Protocol;
(c) Identify if other national, regional and/or international instruments adequately regulate the organisms, components or products derived from synthetic biology techniques in so far as they impact on the objectives of the Convention on Biological Diversity and its Protocols;
(d) Work towards an operational definition of synthetic biology, comprising inclusion and exclusion criteria, using all relevant information, based on scientific and peer reviewed studies;
(e) Identify the potential benefits and risks of organisms, components and products arising from synthetic biology techniques to the conservation and sustainable use of biodiversity and related human health and socioeconomic impacts relevant to the mandate of the Convention and its Protocols;
(f) Building on the work on risk assessment and risk management undertaken by the Cartagena Protocol, compile information on best practices on risk assessment and monitoring regimes currently used by Parties to the Convention on Biological Diversity and other Governments, including transboundary movement, to inform those who do not have national risk assessment or monitoring regimes, or are in the process of reviewing their current risk assessment or monitoring regimes, to help those Parties and other Governments regulate organisms, components and products from synthetic biology techniques appropriately;
(g) Identify if the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology relevant to the objectives of the Convention on Biological Diversity and its Protocols, in particular threats of significant reduction or loss of biological diversity.
 The Ad Hoc Technical Expert Group will be convened in accordance with the modus operandi of the Subsidiary Body on Scientific, Technical and Technological Advice, except that there will be 5 to 8 experts nominated by each of the five regions.