Re: [DIYbio] Re: Biosecurity

UN REPORT
Frontiers 2018/19: Emerging Issues of Environmental Concern
04 March 2019
Authors: UN Environment
""From the innovations and ethical dilemmas of synthetic biology to
the options for appropriate international adaptation to climate
change: Frontiers 2018/19 explores the emerging environmental issues
facing the planet
...

The ability to successfully alter organisms at the genetic level has
excited scientists and the general public alike. Gene-editing
techniques are advancing rapidly, bringing the promise of many
biological and ecological benefits, from eradicating human diseases to
preventing species extinction. CRISPR-Cas9 is the latest, quickest
tool in the genetic editing tool box, allowing extraordinary precision
in the manipulation of genomes.

However, this ability to create synthetic life and alter existing DNA
carries with it the risk of cross contamination and unintended
consequences. Hacking the code of life has such major implications
that there is an urgent need for governing bodies to collaborate and
cooperate in ensuring safe research and development in this field. The
rise of the DIY biohacker and the risk of the accidental release of
genetically modified organisms into the environment is a cause for
regulatory concern.


The Convention on Biological Diversity considers that the following
operational definition is useful as a starting point for the
purpose of facilitating scientific and technical deliberations under
the Convention and its Protocols:
"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."20


** The intentional or accidental release of genetically engineered
organisms into the environment could have significant negative impacts
on both human and environmental health. Misuse of these technologies
and a failure to account
for unintended consequences could cause irreversible environmental
damage and pose significant geopolitical threats.17 The potential
far-reaching impacts of synthetic biology demand governance methods
and research guidelines that promote its ethical and responsible
use.18,19


CRISPR-Cas9 genome editing technique
The discovery of CRISPR-Cas9 has changed the entire outlook of
synthetic biology research.
It enables scientists to cut out a particular DNA segment of a desired
sequence or replace it with a new
DNA strand. Many fields of medical research require such editing
precision to revolutionize treatments.
However, the technique is also subject to scrutiny for its safety as
it involves a potential off-target effect, whereby it inadvertently
cuts out DNA that has a similar sequence to the targeted strand,
potentially triggering cancer in edited cells.


Do-It-Yourself Biology or DIY Bio
The movement of so-called 'citizen scientists' interested in
performing synthetic biology experiments has gained significant
traction globally. Biology enthusiasts – many without scientific
background – meet in garage labs to conduct experiments using
specialised DIY kits and simple protocols available online.
Some of the group have specialised equipment and hire professional
staff to help citizen scientists, biohackers and biology enthusiasts
in developing their projects.

Risks and policy considerations
There are concerns that synthetic biology could be used to re-engineer
existing pathogenic viruses, making them more dangerous or produce
biochemicals with only modest resources and organizational footprint.
Synthetic biology presents new challenges that need to be addressed
through the consolidated action of governmental and international
bodies. Development of effective methods to better manage emerging
risks is essential in ensuring technological safety.

Innovating with wisdom
The release of genetically engineered organisms accidentally or
intentionally into the environment has raised valid concerns about
biosafety and unpredictable consequences. For organisms engineered in
closed research or industrial facilities, containment procedures and
enforced regulations on waste disposal help to avoid an escape,
although this is never fail-proof.63 In the case of intentional
release, concerns over potential genetic cross-contamination between
species, ecological interactions and impacts on ecosystems and their
services remain largely unresolved.64 Altering a disease carrier
genetically could potentially cause a pathogen to evolve and become
more virulent, or to be carried by a new vector.65
To date, CRISPR-based gene drives have been tested only
on small populations in controlled settings, with one recent
experiment successfully collapsing the entire malaria- carrying
mosquito population in the laboratory.66 As a first step towards wider
trials, Target Malaria has recently gained permission to release
10,000 modified mosquitoes in Burkina Faso. These specimens will be
genetically engineered to be sterile, but with no gene drives, to test
how well they compete with wild males.67 However, such field trials to
evaluate the efficacy of the gene-drive system could pose inherent
risks.68,69

Under the precautionary principle, stringent risk assessment and the
inclusion of diverse stakeholder perspectives should be applied in the
development and handling of innovative synthetic biology applications
and products.19,70,71 The precautionary principle states that when
human activities may lead to unacceptable harm that is scientifically
plausible but uncertain, action should be taken to avoid or diminish
that harm.72 A concept of substantial equivalence – that a genetically
modified organism is as safe as its traditional counterpart – is often
mentioned in conjunction with the precautionary principle.73 Some
countries have extensive policy and regulations in place concerning
genetic engineering and research, while for others, non-functional
regulatory systems, policy gaps and risk-assessment capacity are major
challenges.74-77
Attempts have been made to identify, evaluate and address the ethical
and biosafety concerns of synthetic biology.
The U.S. National Academies of Science, Engineering,
and Medicine published a report on gene drives in 2016 highlighting
the need for stringent environmental risk assessments and deliberation
that charters human values and necessitates rigorous public
engagement.19
In December 2017, the ad-hoc technical expert group on synthetic
biology, established by the Parties to the Convention on Biological
Diversity, concluded that organisms – developed or being developed
through current methods of synthetic biology, including those
containing gene drives – fall under the description of living modified
organisms (LMOs), which are regulated under the legally-binding
Cartagena Protocol.78 With 171 Party nations, the Protocol applies the
precautionary approach and requires that each Party take all necessary
measures to ensure the safe handling, transport and use of the
resulting LMOs.79
SYNBIOSAFE, an EU-funded research project, was established to identify
key issues in safety, security, risk management ethics and,
importantly, the science–society interface, which emphasizes public
education and dialogue among scientists, businesses, government, and
ethicists.80,81 Some gene-drive developers have also proposed ethical
research guidelines that emphasize the need for meaningful public
engagement.82
Nevertheless, the intentional release of modified organisms and their
potential to permanently transform wild species and cross
international borders will likely test the limits of current policy,
leading some environmental groups to call for a moratorium on all
gene-drive research.83 Other regulatory concerns focus on the
potential use of synthetic biology for military offensive
purposes.84,85



** Citizen scientists, biohackers and garage labs
Synthetic biology and genome editing have attracted interest not only
from companies, but also regular citizens. Do-It-Yourself Biology,
also known as "DIY Bio", the movement of "citizen scientists"
interested in synthetic biology experiments has become an
international phenomenon over the last decade. Often with little prior
knowledge of the field, enthusiasts meet in makeshift
labs to take crash courses in biotechnology and conduct hands-on
experiments.90,91 Simple protocols found online and specialized kits
costing US$150–1,600 have driven the movement's rapid expansion.
DIY Bio labs can be found in most major cities and by 2017 there were
about 168 groups worldwide.92,93 Regulating
the use of easily accessible and low-cost technologies
like CRISPR and gene editing kits will likely be a challenge for
authorities. There is also growing concern that the technology could
be misused by terrorists to destroy agricultural crops or turn
harmless microbes into biological weapons.94


Synthetic Biology: Re-engineering the environment
Lead Authors
Bartlomiej Kolodziejczyk, H2SG Energy Pte. Ltd., Singapore Natalie
Kofler, Yale Institute for Biospheric Studies, Yale University,
Connecticut, United States
Contributors and Reviewers
Marianela Araya, Convention on Biological Diversity, Montreal, Canada
James Bull, College of Natural Sciences, University of Texas at
Austin, Texas, United States
Jackson Champer, Department of Biological Statistics and Computational
Biology, Cornell University, New York, United States
Chen Liu, Department of Biological Statistics and Computational
Biology, Cornell University, New York, United States
Yongyuth Yuthavong, National Science and Technology Development Agency
of Thailand, Pathumthani, Thailand


""

--
## Jonathan Cline
## jcline@ieee.org
## Mobile: +1-805-617-0223
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