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Current Activities of the Online Forum on Synthetic Biology

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Discussion Summary [#8801]
POSTED ON BEHALF OF MARIA ANDREA ORJUELA
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Dear Forum participants,

I would like to thank you all for your contributions to topic 2 of the discussion which focused on “Further analysis of evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention”. There were 119 comments made by participants from 19 Parties, 1 non Party and 17 organisations.

With regards to the benefits and adverse effects of living organisms that have been produced through synthetic biology techniques, participants pointed to several of the effects that were discussed when reviewing the recent technological developments within the field of synthetic biology to assess if the developments could lead to impacts on biodiversity and the three objectives of the Convention and in past meetings held by the CBD on synthetic biology, as indicated in the summary of the discussion which is available at http://bch.cbd.int/synbio/open-ended/discussion/?threadid=8726. A number of references supporting the claims of either the benefits or adverse effects of such organisms were also included. These references are attached to this post as an excel document.

Several participants highlighted that to date there have been no organisms that have been developed through synthetic biology techniques that have been released into the environment and as such any claims of evidence put forward regarding their benefits and adverse effects would be based on models or experiments under contained use, such as in laboratories, and may not be fully reliable. By extension, other participants pointed to the experience gained through the use of “traditional” LMOs which have been released into the environment as an example from which information can be extrapolated regarding the potential benefits and adverse effects of living organisms that have been produced through synthetic biology.

Furthermore, some participants noted that the examples provided during the discussion came from research which may not have been carried out to evaluate the impact of the organisms, components and products of synthetic biology on the three objectives of the Convention, particularly since potential benefits and adverse effects on biodiversity are often indirect and difficult to measure.

There were also concerns expressed by some participants regarding the timeframes during which some of the research that was presented as evidence took place. They indicated that several of the examples provided stem from short term experiments and analyses that did not cover a large enough amount of time to confirm the benefits and adverse effects on biodiversity of the living organisms produced through synthetic biology. These participants argued that long-term tests are necessary.

There was not a significant amount of discussion on the benefits and adverse effects of the components and products of synthetic biology. Several participants agreed that the benefits and adverse effects of components and products of synthetic biology would be similar from those obtained by through other techniques. Participants also pointed to the availability of regulations, which are outside the scope of the CBD, including those that focus on pharmaceuticals, chemicals, and food and feed safety, that are useful in assessing the benefits and adverse effects of the components and products of synthetic biology. Other participants, however, stated that those regulations are not adequate or sufficient to assess the benefits and adverse effects of all components and products of synthetic biology.

Furthermore, some participants highlighted the need to take into account the fair and equitable sharing of the benefits arising out of the utilization of the genetic resources that are used as components of synthetic biology applications, including in the context of digital sequence information.

In addition to the comments made regarding the topic of discussion, several interventions were also made on the issue of risk assessment. Several participants reiterated that current risk assessment methodologies are being applied to organisms produced by synthetic biology. On the other hand, other participants indicated that current risk assessment methodologies, which are based on the principles outlined in Annex 3 of the Cartagena Protocol, may not be adequate to assess the risks of organisms that were developed through techniques that did not exist when the Cartagena Protocol was negotiated, such as gene drive technologies or LMOs for which there may not be an appropriate comparator, and, therefore, assessing their risk may not be possible under existing frameworks that use the methodology in Annex 3 as the basis for their risk assessments. In light of this, some participants suggested that the experience gained from invasive alien species, such as the unintended negative impacts of biocontrol agents, could provide useful information on potential adverse effects that may need to be considered when assessing the risks of organisms developed through synthetic biology that may be released into the environment. Finally, notwithstanding the scope and objective of the Cartagena Protocol on Biosafety, some participants noted that the phenotype of an organism, rather than the method by which it was produced, should dictate the need for assessing the risks and potential impacts on biodiversity. Furthermore, they also pointed to research that is taking place in order to limit the possible adverse effects of gene drives, such as self-limiting gene-drive technologies, taking into account among other things the likelihood for the development of resistance to gene drive systems.

Finally I would thank you all for your valuable contributions and all the time that you had to dedicate to this exercise. I am sure that your different points of view would be very useful for the upcoming meeting of the AHTEG.

Kind regards,
M. Andrea
posted on 2017-10-25 20:27 UTC by Dina Abdelhakim, SCBD