Download The Ad-hoc Technical Expert Group (AHTEG) in Synthetic Biology

The Ad-hoc Technical Expert Group (AHTEG) in Synthetic Biology1 reaffirmed the need to
observe the precautionary approach in relation to synthetic biology. Its report lists 15
potential adverse impacts of synthetic biology and emphasises the need for
comprehensive case-by-case risk assessments. Disappointingly, no agreement could be
reached as to “whether or not current methodologies to address the environmental
impacts of the components and products of synthetic biology are adequate or even
needed”.
There are many important arguments and reasons why existing regulation of synthetic
biology (both for intentional and unintentional releases) is wholly inadequate, highlighted
in the “Principles for the Oversight of Synthetic Biology” supported by 111 civil society
organisations. 2
Synthetic and other genetically engineered microorganisms are almost always used in
conditions which existing regulations defined as ‘contained’. During the 1980s and ‘90s,
when governments were developing ‘contained use’ regulations for GE microorganisms,
those uses were primarily in the medical sector, and thus inside laboratories. Even then,
evidence of how inadequate such regulations were for preventing a release of GE
microbes was emerging3. Inherent problems with ‘containment’ are analysed in the CBD
Secretariat’s Technical Report on Synthetic Biology, published March 20154.
Today, ‘contained use’ of GE microorganisms commonly means their use in biorefineries
and other industrial plants which are entirely different environments from biotech
laboratories. Regulatory risk assessments of supposedly ‘contained’ industrial uses of GE
microalgae, fungi or bacteria are minimal, even when safe physical containment appears
unlikely and biological containment may not even be attempted. This is illustrated by
two examples:
US synbio company Amyris has been engineering bakers’ yeast to produce farnesene, a
chemical not naturally produced by any microorganism. According to Amyris, this
involved 13 different manipulations to the genome of S. cerevisiae5. Recently, Amyris
has been focussing on another isoprenoid, farnesene to produce small quantities of
biofuels and, primarily, personal care products. Amyris is reported to have been creating
and testing 400,000 yeast strains per week and shipping the most promising ones to
Brazil. The US authorities have waived the requirement for a full risk assessment and
regulatory oversight6. In Brazil, Amyris’s farnesene-producing yeast has been approved
on the basis that baker’s yeast is generally safe, as is the organism from which a gene
was transferred, sweet wormwood. Yet the yeast strains have been subjected to
intensive metabolic engineering and bear little resemblance to any natural organism.
They are designed to produce chemicals which no microorganism can produce in nature.
A risk assessment based on the properties of ordinary bakers’ yeast and sweet
wormwood is clearly inadequate to assessing the risks of such a synthetic yeast.
Because the GMO has been classed as ‘safe’, there is no regulatory oversight of
containment procedures inside Amyris’s refineries. Yet industrial refineries rely on
engineers who have no academic background in biosafety and there are many more
opportunities for GE microorganisms to escape than there would be in closed
laboratories. As the industry magazine Biofuels Digest quoted from an anonymous
‘friend’: “I was in Brazil last month and got an earful about that from a very high up
there on [Amyris]…having worked in nice university labs and clean room pharmaceuticals
they did not know what was awaiting them in the down market dirty world of biofuel.
You can’t make biofuels with anything you got to keep that clean.”7
Another company which also uses synthetic microorganisms and which obtained a waiver
from regulatory oversight and from the requirement for a full risk assessment in the US
is Joule. Joule has been engineering cyanobacteria of the genus Synechococcus so that
they directly convert carbon dioxide contained in seawater into hydrocarbon fuels.8
According to one peer-reviewed article, Synechococcus is one of two genera of
cyanobacteria which “dominate the photoautotrophic picoplankton over vast tracts of the
world’s oceans where they occupy a key position at the base of the marine food web and
contribute significantly to global primary productivity”.9 Despite the keystone role of
Synechococcus in marine ecosystems, not a single assessment of their potential
ecological impacts or likelihood of GE strains surviving in nature has been published. All
that separates Joule’s GE bacteria from the open environment are two thin tubular
plastic sheets, which need to be flushed out regularly10.
A precautionary approach to synthetic biology will be meaningless unless it is translated
into effective regulations that include so-called contained industrial uses of GMOs, in line
with the Principles of Oversight developed by civil society.
1
https://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.pdf
http://libcloud.s3.amazonaws.com/93/ae/9/2287/2/Principles_for_the_oversight_of_synthetic_biology.pdf
3
See for example http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/brief7.pdf
4
https://www.cbd.int/doc/publications/cbd-ts-82-en.pdf
5
http://www.fastcompany.com/3000040/rise-and-fall-company-was-going-have-us-all-using-biofuels
6
http://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-notifications-fy-1998present
7
http://www.biofuelsdigest.com/bdigest/2012/05/07/playing-defense-contamination-and-the-jitter-effect-inadvanced-biofuels/
8
The initiation ketosynthase (FabH) is the sole rate-limiting enzyme of the fatty acid synthase
of Synechococcus sp. PCC 7002, James Kuo and Chaitan Khosla, Metabolic Engineering, March 2014
9
Molecular biology of the marine cyanobacterial genera Proclorococcus and Synechococcus, David J. Scanian
and Nyriee J. West, FEMS Microbiology Ecology, 1st April 2002
10
http://www.google.com/patents/WO2014064602A2?cl=en
2