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IAP Statement on Realising Global Potential in Synthetic Biology: Scientific Opportunities and Good Governance

  • AuthorIAP
  • TitleRealising Global Potential in Synthetic Biology: Scientific Opportunities and Good Governance
  • Release Date7 May 2014
  • Copyright2014
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iap logo 2014 bisSynthetic biology is defined as the deliberate design and construction of customized biological and biochemical systems to perform new or improved functions. While the field is in its infancy, it is already producing results that may have far-reaching implications in fields such as biomedicine, agriculture, land and water decontamination – even nano-machines and novel approaches to information processing.

However, synthetic biology has become a controversial area, as concerns have been expressed in relation to the protection of human health and the environment. Such concerns arise mainly from governance issues associated with biosafety (protecting legitimate users and the environment) and biosecurity (protecting against intentional misuse).

The current IAP Statement addresses these and other key issues, promoting the idea that responsible research and innovation in synthetic biology should be encouraged and supported, and must not be stifled by excessive restrictions, while recommending a broad dialogue between scientists, social scientists, academies, non-governmental organizations and other interested stakeholders, including the general public.

A parallel ‘World View’ commentary on synthetic biology, written by IAP co-chair Volker ter Meulen, was published in Nature on 7 May 2014.

Comments:
  • Braulio de Souza Dias, Executive Secretary, Convention on Biological Diversity (CBD)
    Braulio de Souza Dias, Executive Secretary, Convention on Biological Diversity (CBD) said:
    2 years and 11 months ago
    Convention on Biological Diversity (CBD)
    Thank you for sharing the IAP statement on synthetic biology. The potential positive and negative impacts of synthetic biology on biodiversity and its coverage by the Convention on Biological Diversity, its protocols and other agreements will be discussed at the eighteenth meeting of the Convention's Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA-18, Montreal, 23-28 June 2014). SBSTTA is expected to make a recommendation on this matter that will be further considered at the twelfth meeting of the Conference of the Parties (Pyeongchang, Korea, 6-17 October 2014). An earlier meeting of SBSTTA had already begun to consider synthetic biology and realized that additional information was needed to enable an informed discussion. The purpose of this prolonged process is to enable delegates agree on a way forward that is balanced and well-considered. Documentation to enable this discussion has been completed and made available:

    UNEP/CBD/SBSTTA/18/10 - New and Emerging Issues: Synthetic Biology http://www.cbd.int/doc/meetings/sbstta/sbstta-18/official/sbstta-18-10-en.doc
    UNEP/CBD/SBSTTA/18/INF/3 - New and Emerging Issues Relating to the Conservation and Sustainable Use of Biodiversity - Potential Positive and Negative Impacts of Components, Organisms and Products Resulting from Synthetic Biology Techniques on the Conservation and Sustainable Use of Biodiversity http://www.cbd.int/doc/meetings/sbstta/sbstta-18/information/sbstta-18-inf-03-en.doc
    UNEP/CBD/SBSTTA/18/INF/4 - New and Emerging Issues Relating to the Conservation and Sustainable Use of Biodiversity - Possible Gaps and Overlaps with the Applicable Provisions of the Convention, Its Protocols and Other Relevant Agreements Related to Components, Organisms and Products Resulting from Synthetic Biology Techniques http://www.cbd.int/doc/meetings/sbstta/sbstta-18/information/sbstta-18-inf-04-en.doc

    Given the lengthy preparatory process for this documentation, based on two rounds of peer review of earlier drafts, I regret that you write in your statement "Although many respondents to this CBD consultation considered the draft documents to be informative and a useful starting point for debate, significant concerns were also expressed
    about the text of the documents", without specifying that these concerns were based in a first draft of documentation which was primarily based on the submissions received by the CBD Secretariat, and which has since undergone significant modifications due to an expanded mandate involving a review scientific literature and two rounds of open peer review.

    Thank you for the opportunity to comment on the IAP Statement.

    Braulio de Souza Dias, Executive Secretary, Convention on Biological Diversity
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  • Robin Fears, EASAC
    Robin Fears, EASAC said:
    2 years and 11 months ago
    Report (May 2014) from the J Craig Venter Institute and others on synthetic biology regulation
    SEE: http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-biology-and-the-us-regulatory-system/full-report.pdf

    Although very US-oriented, the Report concludes (like the IAP Statement) that "...US regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed ...synthetic biology". The exceptions relate to the possibility that the number of genetically engineered microbes might overwhelm regulators' capacity to review and that some new methodologies for engineering plants will fall outside current regulations - this latter is probably a US-specific issue and EU regulations are broader (the report notes that the EU precautionary approach is deemed an "unlikely candidate for serious consideration" in thinking about future US regulations).

    This is quite a detailed report and suggests useful options for dealing with those exceptions identified. Thus, it should give further confidence that the perspective taken in the IAP Statement is reasonable.
    Robin Fears, EASAC
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  • Vijaya Kumar, President, National Academy of Sciences of Sri Lanka
    Vijaya Kumar, President, National Academy of Sciences of Sri Lanka said:
    2 years and 11 months ago
    In general we agree with the IAP statement on Realising Global Potential in Synthetic Biology. However, it is our view that the statement should have also flagged some concerns about the need to link the funding of synthetic biology research to safeguards that ensure end-user bio-safety and the prevention of use o research outcomes for unethical purposes .... Nevertheless as mentioned above, we generally agree with the statement and would be pleased to be a signatory to it.

    Vijaya Kumar, President, National Academy of Science of Sri Lanka
    Like 0
  • Ruth Arnon, President, Israel Academy of Sciences and Humanities
    Ruth Arnon, President, Israel Academy of Sciences and Humanities said:
    2 years and 11 months ago
    Thank you for inviting signatories to the IAP Statement on Realising Global Potential in Synthetic Biology: Scientific Opportunities and Good Governance. This is a well thought out and concise statement dealing with what will no doubt become an increasingly important topic. Please convey our thanks to the members of the Working Group and others involved in its preparation and commend them for their thoroughness. As an increasing number of synthetic biological applications are designed, we hope that the safeguards will be in place to provide the requisite safety and to prevent the malicious misuse of potentially dual use systems.
    The Israel Academy of Sciences and Humanities is in full accord with this statement and gladly agrees to be included as a signatory.

    Ruth Arnon, President, The Israel Academy of Sciences and Humanities
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  • Jeroen Frietman, Policy Officer, Royal Netherlands Academy of Arts and Sciences (KNAW)
    Jeroen Frietman, Policy Officer, Royal Netherlands Academy of Arts and Sciences (KNAW) said:
    2 years and 11 months ago
    The private sector is also active in realizing (or at least initiating) innovations in synthetic biology – is the focus now not too exclusively (or solely even) on the public sector? This is relevant c.q. the ‘integrity code’, as it is the intention to distribute this widely within the global community.

    The statement is somewhat ‘safely’ formulated as for potential impact for Grand Challenges. It is wise not to exaggerate expectations, but there is a risk that the potential impact might be overlooked or is insufficiently highlighted.

    It is very good to point out the existing Regulatory systems, with the notion that when rDNA techniques and products will change significantly, rules and regulations will need to be adjusted. A similar discussion is held within the SynBERC community, where unfamiliarity with standing GMO rules as the renewed discussions around containment and introduction of new safety principles is being discussed. In the private sector many (participating) firms [too] underwrite and support the importance of this. No innovations are possible in a societal vacuum. Without sufficient measures much of the current work/research done by many research groups/firms may be put on hold and they might deterred for a long period of time.

    Jeroen Frietman, Policy Officer/Beleidsmedewerker, ROYAL NETHERLANDS ACADEMY OF ARTS AND SCIENCES (KNAW)
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