The U.S. government blocked dozens of life science experiments over the past decade because they were deemed to pose undue risks to public health and safety.
Between 2006 and 2013, researchers submitted 618 potentially restricted experiment proposals for review by the Centers for Disease Control (CDC) Division of Select Agents and Toxins (DSAT), according to a new study published in the journal Health Security.
Fifteen percent of those (91) were found to meet the regulatory definition of a “restricted experiment.” 31 of those experiments were nevertheless approved because they included appropriate safety measures.
But “DSAT did not approve 60 restricted experiment requests due to potentially serious biosafety risks to public health and safety,” researchers found. “All 60 denied restricted experiments proposed inserting drug resistance traits into select agents that could compromise the control of disease.”
See Review of Restricted Experiment Requests, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 2006-2013 (abstract only) by Jacinta Smith, Denise Gangadharan, and Robbin Weyant, Health Security, Vol. 13, No. 5, September 2015: 307-316.
Regulatory restrictions on research can infringe on academic freedom and may have the unintended consequence of foreclosing important — and beneficial — avenues of scientific investigation.
But the risks involved in genetic manipulation of biological agents are so profound that almost everyone agrees that some limits are necessary and appropriate.
“A product resulting from a restricted experiment has the potential to be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals and/or the environment,” the authors wrote. “In addition, the accidental release of a product of a restricted experiment may compromise the control or treatment of the disease agent in humans, animals, and/or plants.”
There have been four reported cases involving violations of restricted experiment regulations in recent years, the authors noted. Two of the restricted experiment violations resulted in civil penalties ranging from $40,000 to $1 million.
Some say the existing regulatory regime does not go far enough to restrict hazardous research.
“In the current Wild West of otherwise completely unregulated, and otherwise nearly completely unmonitored, US pathogens research, the requirement for review of ‘restricted experiments’ under the select agent rule is the one small bright spot,” said Richard H. Ebright, a molecular biologist at Rutgers University.
He noted that current regulations specify only two categories of potentially restricted experiments, which leaves much research on pathogens beyond regulatory control or oversight.
“The most effective avenue for the [US government] to implement a requirement for review of other pathogen research projects–for example, to implement a requirement for review of pathogen research projects that create new potential pandemic pathogens–would be to add additional ‘restricted experiments’ to the select agent rule,” Dr. Ebright said.
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