Coalition Wants Global Moratorium on 'Extreme' Synthetic Bio Businesses
Parijata D. Mackey
http://www.genomeweb.com/coalition-wants-moratorium-extreme-synthetic-bio-businesses
NEW YORK (GenomeWeb News) – An international advocacy coalition today
called for a moratorium on the development of new synthetic organisms
for commercial use while new international regulations for governing
the synthetic biology sector are created to protect the environment
and people from unknown perils.
The coalition said today that synbio represents "extreme genetic
engineering." It said there currently is little or no governance over
synthetic organisms, and private companies cannot be trusted to
self-regulate and protect people and the environment from risk and
harm.
"We are calling for a global moratorium on the release and commercial
use of synthetic organisms until we have established a public interest
research agenda, examined alternatives, developed the proper
regulations, and put into place rigorous biosafety measures," Carolyn
Raffensperger, executive director of the Science and Environmental
Health Network, said in a statement today.
"Self-regulation of the synthetic biology industry simply won't work,"
added Andy Kimbrell, executive director of the International Center
for Technology Assessment. "Current laws and regulations around
biotechnology are outdated and inadequate to deal with the novel risks
posed by synthetic biology technologies and their products."
Friends of the Earth and over 100 international groups focused on
environmental, bioscience, food safety, human and consumer rights
issues, and religion, said in a report published today that although
the synbio market had a value of more than $1.6 billion in 2011 and
could hit $10.8 billion by 2016, there has been "little or no
governance of the industry or assessment of the novel risks posed by
synthetic organisms."
In a conference call today unveiling the report, Jaydee Hanson, policy
director at the International Center for Technology Assessment, said
that the first creation of a synthetic genome and its implantation
into a microbe by the J. Craig Venter Institute in 2010 "should have
been a wake-up call for governments around the world, but little new
oversight resulted."
"The ability to synthesize DNA and create synthetic organisms and
products is far outpacing our understanding of how these novel
products work in the real world. Even engineering simple organisms
could have major ecological and health effects," Hanson said.
In its report, "The Principles for the Oversight of Synthetic
Biology," the consortium calls for governments to take specific steps
to account for a range of possible effects caused by synthetic
organisms.
It calls for a moratorium on the release and commercial use of
synthetic organisms, cells, or genomes, until a government research
agenda has been established to study the public's interest. The
moratorium also would hold while alternative approaches are considered
and risk assessments are made, and international oversight and
security mechanisms are developed.
The group also wants mandatory regulations that would treat synthetic
biology as a unique activity and would be stronger than current the
regulations on pathogens, containment, drugs, and worker protections.
The report seeks a number of public health and worker safety
regulations for preventing human exposures to synthetic organisms that
have not been proven safe. These would include protocols to ensure
that the organisms are securely contained, that the public would be
informed of the nature of the work being conducted in the community,
and that workers and the public be informed of risks associated with
synthetic biology and organisms. Another requirement suggested by the
group is that methods be available for tracking, disabling, or
destroying synbio strains, if necessary.
Requirements also need to be put in place to protect against the
potential dangers that synthetic organisms might pose if they are
released into the environment, intentionally or unintentionally, the
consortium said. "The capacity of each synthetic organism to survive
in the environment and reproduce must be known before any such
organisms leave the laboratory. … Once released into the environment,
these organisms may be impossible to recall or eliminate," the group
said its report.
To that end, the consortium wants governments to require that
premarket environmental impact assessments are conducted for each
distinct synthetic organism and each product derived from them.
Among other proposals, the coalition also said it wants a prohibition
on the use of synthetic biology to change the human genetic makeup,
human genome, epigenome, or microbiome, because any such genetic
alterations "are too risky and fraught with ethical concerns."
Gregory Kaebnick, a scholar at the Hastings Center, a non-partisan
bioethics organization, told GenomeWeb Daily News today that the
coalition is "calling attention to an important set of issues."
However, Kaebnick said that the coalition has focused its
recommendations too much on "halting commercialization," and the
report appears to have an "anti-corporate" message. He also said that
they failed to consider potential dangers of research projects, such
as the recent development of a dangerous new strain of H5N1.
Kaebnick also took issue with the coalition's central contentions
concerning regulation.
"I don't think it's true that synthetic biology is developing with
little oversight or regulation. There is a fair amount of talk at the
federal level about it. … The question is: What are the gaps in the
existing regulations? How do we deal with a technology that is
changing and evolving very rapidly? How do we set up oversight
mechanisms?"
The Obama Administration responded to JCVI's synthetic microbe by
immediately commissioning a report, released in 2010, which included a
number of recommendations for addressing safety, security, and ethical
questions involved in synbio.
That report, from the Presidential Commission for the Study of
Bioethical Issues, advised a policy based in prudent vigilance that
involves ways to use government and private sector resources to
oversee synthetic bio research and business without stifling
innovation.
As GWDN reported last month, the administration has been pursuing
implementation of some of those recommendations, although about half
of them have spurred little or no actions or have been disregarded.
Kaebnick suggested that the coalition's focus on corporations and its
heightened concern about synthetic biology business, as opposed to
genetic engineering research, may have colored its report and "gotten
in the way of the message."
"People freak out a little bit when they see the words 'synthetic
biology or 'genetic engineering,' particularly when you tack the word
'extreme' in front of it," Kaebnick said.
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Parijata D. Mackey
US: 3054096136
UK: 7427770542
pari...@gmail.com
www.parijata.com
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