policy

UN CBD COP13: Outcomes relevant to Synthetic Biology

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Dear Synbio enthusiasts,

three weeks ago, we invited you to follow and contribute to our participation in the 13th Conference of the Parties to the UN Convention on Biological Diversity (COP13) and the parallel Meetings of the Parties to the Cartagena Protocol on Biosafety (CP-MOP8) and the Nagoya Protocol on Access and Benefit-sharing (NP-MOP2). 

Following conclusion of this year's UN CBD events on December 17th, we would like to share with you the below draft outcomes which will have an impact on the future regulation of our discipline.

In case you do not have a particularly keen interest in science policy and governance (yet) or you simply lack the time to read through all of the below bullet points, here is a -considerably simplified- summary:

Synthetic biology may be subject to the same regulatory framework which already exists for classical biotechnology. However, a precautionary approach to synthetic biology has been encouraged, and methodologies for risk assessment of synthetic biology may be updated as new developments emerge.

 

More details are given below:


  • it has been reaffirmed that Parties and other Governments are urged and invited, respectively, to take a precautionary approach when addressing threats of significant reduction or loss of biological diversity posed by organisms, components, and products resulting from synthetic biology.

  • the draft operational definition "synthetic biology is a further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems" has been acknowledged, yet further refinement of this definition has been noted as neccessary.

  • it has been noted that living organisms developed or being developed through current applications of synthetic biology are similar to living modified organisms (LMOs) as defined in the Cartagena Protocol, and that general principles and methodologies for risk assessment under this Protocol and existing biosafety frameworks provide a good basis for risk assessment regarding such LMOs. However, it has also been noted that such methodologies may need to be updated and adapted for current and future developments and applications of synthetic biology.

  • it has been noted that it remains unclear whether or not some organisms created through synthetic biology would fall under the definition of LMOs under the Cartagena Protocol, and whether or not some results of a synthetic biology application are living.

  • Parties have been invited to take into account socio-economic, cultural, and ethical considerations when identifying the potential benefits and potential adverse effects of organisms, components, and products resulting from synthetic biology techniques.

  • Parties, other Governments, relevant organizations, and indigenous peoples have been invited to share experiences and fill knowledge gaps related to potential benefits and potential adverse effects of synthetic biology products as outlined above, to promote public and multi-stakeholder dialogue, and to cooperate in developing guidance and capacity.

  • it has been decided to extend the mandate of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology to make recommendations relevant to the above unresolved issues.

  • it has been decided that, at its next meeting, the Convention will consider any potential implications of the use of digital sequence information on genetic resources for (i) the conservation of biological diversity, (ii) the sustainable use of its components, and (iii) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. As with potential benefits and potential adverse effects of synthetic biology, relevant information and experiences have been invited from stakeholders, and establishment of a dedicated AHTEG has been decided.


In case you would like to dig deeper into the material, the official meeting documents can be found here.

We, the EUSynBioS Steering Committee, will make an effort to stay involved in this process, and to represent your opinion at future meetings of the UN Convention on Biological Diversity. It is for the sake of a future which allows us to freely and responsibly pursue our scientific careers in an appropriate regulatory environment.

All the best,

-Christian

 

We are an Observer to UN CBD COP13/CP-MOP8/NP-MOP2

 
COP13

Dear SynBio enthusiasts,

in three days' time, the Parties to the UN Convention on Biological Diversity will come together in Cancun, Mexico for their 13th conference (COP13). In parallel,  Meetings of the Parties to the Cartagena Protocol on Biosafety (CP-MOP8) and the Nagoya Protocol on Access and Benefit-sharing (NP-MOP2) will take place.

At this event, an internationally agreed operational definition of synthetic biology shall be finalized, with wide implications for the nascent discipline’s future regulation. Related key decisions to be made include the status of digital DNA sequence information in scope of the Nagoya Protocol’s Access and Benefit-sharing (ABS) rules, and the extent of Socio-Economic, Cultural, and Ethical considerations (SECE) being encouraged as key part of research efforts. We feel that it is imperative for the next generation of young scientists to have a voice in these decisions.

The CBD Secretariat has kindly admitted EUSynBioS as an Observer organization to this event, which gives you, the EUSynBioS community, a unique opportunity to have a voice. Even though Observers have no formal right to vote, the opinion of the next generation of synthetic biology researchers does count, and will on site be communicated in collaboration with partner organizations such as the Public Research & Regulation Initiative.

I would hence like to invite you to share your opinion, your suggestions, and concerns related to the Cancun negotiations with us. You can do so either via our twitter channel @EUSynBioS, or directly by email to sc@eusynbios.org.

You can also follow the official webcast here.

We are looking forward to hearing from you!

Christian, on behalf of the EUSynBioS Steering Committee

 

UK parliamentary office weighs in on synbio regulation

The UK Parliamentary Office of Science and Technology issued a Note on Synthetic Biology

The UK Parliamentary Office of Science and Technology issued a Note on Synthetic Biology

POST (Parliamentary Office of Science and Technology) is a UK office tasked with providing information for both the House of Commons and House of Lords. It allows all members of the UK parliament to make the most informed choice when it comes to voting on policy and law. POST does this, in part, by publishing POSTnotes--short documents which summarise a complex topic.

One goal of POST is to be proactive about information gathering. So that, developments on the horizons of science and technology, are accounted for when the government wished or needs to become involved in these areas. To that end POST published, in May, a note on the Regulation of Synthetic Biology.

Authored by Louise Connell and Peter Border, the short report first gives a background on Synthetic Biology as a field. It talks about synthetic biology as first, developing tools enabling computational design, genome editing, DNA synthesis and sequencing. It also introduces the core principle of standardisation. It then speaks to efforts to use these technologies for various applications, including metabolic engineering, creating protocells and xenobiology. The report goes on to detail current products of synthetic biology such as artemisinin and vanillin. Finally they introduce the potential for environmental, ethical, legal and societal issues to be raised by synthetic biology.

The meat of the report focuses on regulation as it currently stands and potential areas where there isn’t any regulation into which synthetic biology can fit. Currently synthetic biology is treated much the same way genetic modification has always been treated by the EU. Work is evaluated based on whether it is for lab/contained use or if it is a deliberate environmental release. This could be potentially problematic for some projects which fall between these two directives. The example they give is an environmental biosensor which is contained both physically and biologically. Before environmental release novel organisms are compared to wild-type organisms. As synthetic biology advances, it may be difficult to do this as there may be no wild strain similar to a completely artificial one developed in a lab. And finally, there is concern that, with a rapid growth in the range and complexity of technology, it will be impossible to evaluate every project on a case-by-case basis. The report mentions the difference between the EU system and that used in the USA and Canada and mentions the recommendation by the The House of Commons Science and Technology Select Committee to move to a trait-based regulation system as used in North America.


Synthetic Biology will become a booming area of research. So much so that the recently elected Conservative government picked it as one of the ‘8 great technologies’ in their manifesto, pledging to direct more funding towards it. With an increase in research it is more important than ever that policy and regulation is in place to protect people and the environment while fostering a system in which the best work can be done. Well informed policy makers and politicians are a key to this. This POST summary is not only well written, researched and thoughtful but may be influential to informing regulation affecting synthetic biology in the future.

 

 

Written by:

Oscar Sanderson

Oscar is a microbiology graduate and founding member of the University of Reading iGEM team.

 

Edited by: Devang Mehta

Disclaimer: Views and opinions expressed in EUSynBioS Pulse articles belong solely to the writer(s). They do not reflect the opinion of the Community, the Advisory Board or the Steering Committee