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Coalition Wants Moratorium on 'Extreme' Synthetic Bio Businesses

By Matt Jones

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 "Current laws and regulations around biotechnology are outdated and inadequate to deal with the novel risks posed by synthetic biology technologies and their products."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.