WASHINGTON, June 8, 2016 – Gene drives – which use genetic information to eliminate undesirable traits in an organisms – hold great promise for solving public health, ecological or agricultural problems. But that doesn’t mean society should rush to release them into the environment without fully examining their impacts, a National Academy of Sciences panel has concluded.

“The potential for gene drives to spread throughout a population, to persist in the environment, and to cause irreversible effects on organisms and ecosystems, calls for a robust method to assess risks,” the panel found in a report released today, noting that the current regulatory structure is not prepared to address those risks.

Regulation of gene drive research does not fall within the purview of any of the agencies – FDA, USDA and EPA – involved in the government’s Coordinated Framework for the Regulation of Biotechnology, the report said.

The report recommends that research institutions, funders, and regulators “develop and maintain clear policies and mechanisms for how public engagement will factor into research, ecological risk assessments, and public policy decisions about gene drives,” NAS said.

The report defines a drive as “a system of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced.”

“In contrast with other genetic modification techniques, which are typically designed to minimize inheritance or transmission of altered genetic elements, the goal of a gene drive is to rapidly spread genetic information throughout a population,” the report said.

“If the current pace of change in general genetics is thrilling, the pace of change in gene drive research is breathtaking,” the co-chairs of the committee that released the report said in the preface.

James P. Collins, a professor of Natural History and the Environment in the School of Life Sciences at Arizona State University, and Elizabeth Heitman, associate professor of medical ethics in the Center for Biomedical Ethics and Society at Vanderbilt University, added, “Not surprisingly, the depth, breadth, and practical implications of scientific advances in gene drive research are simultaneously raising many challenges at the interface of science and society.”

“Before gene-drive modified organisms are put into the environment, our committee urges caution — a lot more research is needed to understand the scientific, ethical, regulatory, and social consequences of releasing such organisms,” Collins said.

Agriculture is one area where potential benefits need to be weighed against the risks.

“Gene drives developed for agricultural purposes could also have adverse effects on human well-being,” the report said. “Transfer of a suppression drive to a non-target wild species could have both adverse environmental outcomes and harmful effects on vegetable crops, for example. Palmer amaranth is a damaging weed in the United States, but related Amaranthus species are cultivated for food in in Mexico, South America, India, and China.”

Suppression drives are used to reduce the number of organisms in a target population.

In a brief case study, the report called Palmer amaranth, also known as pigweed, a good candidate for gene-drive technology for a number of reasons, including: It’s an annual plant, “so it has yearly sexual reproduction and a rapid generation time,” and it’s wind-pollinated, suggesting that its eradication would not harm insect pollinators.

The weed infests the South. In Georgia in 2010 and 2011, growers spent over $100 million to control glyphosate-resistant pigweed.

The idea would be to target the genes that confer resistance to glyphosate and reestablish the population’s susceptibility. “If the gene drive succeeded and susceptibility became fixed, glyphosate could then be used again as a tool to limit Palmer amaranth populations.”

The study was sponsored by the National Institutes of Health, the Foundation for the National Institutes of Health, and the National Academy of Sciences Biology and Biotechnology Fund. The Defense Advanced Research Projects Agency and the Bill & Melinda Gates Foundation provided funding to NIH and FNIH, respectively, in support of the study.


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