“Without proper safeguards, we risk letting synthetic organisms and their products out of the laboratory with unknown potential to disrupt ecosystems, threaten human health and undermine social, economic and cultural rights,” the coalition said in a new report.
The technology to manipulate the genes of bacteria, yeast and other organisms has existed since the 1970s, leading to pest-resistant crops, bacteria that produce human insulin and other breakthroughs.
But in 2010, biologist J. Craig Venter announced that his institute had invented “synthetic biology” by transplanting the entire genome of one bacterium into a different species, which then reproduced. While not qualifying as an entirely new organism, the lab-built microbe did fuel concerns that this technology presented new and hard-to-quantify risks.
The White House jumped in, with the Presidential Commission for the Study of Bioethical Issues recommending in 2010 that federal agencies adopt a “middle course” that encouraged enhanced oversight and careful consideration of possible risks but no new laws or regulations.
Environmental groups say those measures don’t go far enough.
“The field is evolving incredibly rapidly in the face of almost no regulation,” said Eric Hoffman of Friends of the Earth. “A moratorium puts the brakes on to allow society time to decide which applications are okay and which aren’t.”
Representatives of the biotechnology industry say that genetically modified organisms are already adequately regulated by the Environmental Protection Agency, the U.S. Agriculture Department, the Food and Drug Administration and other agencies.
“I think the report’s kind of silly, frankly. It makes no sense to call for a moratorium,” said Brett Erickson, executive vice president of the Biotechnology Industry Organization, a trade group. “We’ve been doing genetic engineering for 30 years, and we’ve been doing it safely. People are hyping this as something new.”
The burden of proof for safety should fall on companies designing new organisms, the environmental groups said, with synthetic organisms subjected to independent study and corralled by “the strictest levels of physical, biological and geographical containment.”
Hoffman said a number of government agencies should help regulate synthetic biology, including the Energy Department, which funds research in the field; the USDA; the FDA; and the Centers for Disease Control and Prevention.
Work in synthetic biology is still confined to laboratories, but researchers see potential for advances in energy production, medicine and other fields.
Think tanks are also getting involved in the debate over how to regulate the field. In 2010, the Woodrow Wilson International Center for Scholars launched a project on synthetic biology to push for more research on the risks and benefits of new genetic technology.
“The more engaged people are — not just the public, but federal agencies, regulatory agencies and scientists — the better off we are in terms of reaping benefits of these technologies,” said Todd Kuiken, a scientist at the center who is engaged in that project but was not involved in the report released Tuesday.
Kuiken added that government agencies have done little to respond to the recommendations made by the president’s commission 15 months ago.“We approached numerous agencies, including the White House Office of Science and Technology Policy, which should be coordinating this activity. They gave us nothing. Literally nothing.”
Allison A. Snow, a plant ecologist at Ohio State University who keeps a close eye on synthetic biology but was not involved in the new report, said, “The technology is outpacing the research needed to understand environmental risks. This is the time, when technology is just getting started, to look at the risks.”