The National Academies of Sciences, Engineering and Medicine (NAS)
has released a study examining research into man-made gene drives,
a type of gene editing that allows for the spread of gene modifications
“throughout a population of organisms intentionally.” Titled Gene
Drives on the Horizon: Advancing Science, Navigating Uncertainty,
and Aligning Research with Public Values, the report focuses on
techniques that use segments of bacterial DNA—such as clustered
regularly-interspaced short palindromic repeats (CRISPR)—paired with a
guide protein (CRISPR-associated protein 9, or Cas9) “to make targeted
cuts in an organism’s genome.” Organisms modified using CRISPR-Cas9
then pass these changes to their offspring through sexual reproduction,
a process that allows scientists to alter whole populations in an effort to
eradicate insect-borne infectious diseases, for example.

Calling these developments “both encouraging and concerning,” the
report seeks to provide “an independent, objective assessment of the
state of knowledge and responsible practices for research, risk assessment,
public engagement, and the development of public policies on
gene drive technologies.” In particular, the study addresses, among other
things, (i) human values and welfare, (ii) environmental considerations,
(iii) scientific approaches to reducing potential risks, (iv) the need for
ecological risk assessments, (v) avenues for public and stakeholder
engagement, and (vi) governance of gene drives.

To mitigate potential drawbacks to gene drives, the NAS committee
advocates “a phased testing pathway, such as the one outlined by the
World Health Organization (WHO) for testing genetically modified
mosquitoes,” as well as ecological risk assessments designed to “trace
cause-and-effect pathways” and “quantify the probability of specific
outcomes.” The study also notes that, in addition to finding new avenues
for public engagement, researchers and policymakers must develop
best practices for ensuring biosafety while working to resolve regulatory
overlaps and loopholes.

“In the United States, regulation of gene-drive modified organisms will
most likely fall under the Coordinated Framework for the Regulation
of Biotechnology, which includes the U.S. Food and Drug Administration,
the U.S. Department of Agriculture, and the U.S. Environmental
Protection Agency,” explains the report summary. “The U.S. government
will need to clarify the assignment of regulatory responsibilities for field
releases of gene-drive modified organisms, including the roles of relevant
agencies that are not currently included in the Coordinated Framework
for the Regulation of Biotechnology.”

Citing the likely benefits of gene-drive modified organisms, the report
offers support for basic and applied research and highly-controlled field
trials, while urging researchers to “establish open-access, online repositories
of data on gene drives as well as standard operating procedures for
gene drive research.” As the report overview concludes, “It is important
to note that a one-size-fits-all approach to governance is not likely to
be appropriate… Governance and regulation of gene drive research will
need to be proportionate to the hazards posed by the specific activity, and
evaluated on a case-by-case basis. Because of the existing uncertainties
associated with gene drives, regulation will be needed that facilitates
fundamental, applied, and translational research so that the potential
harms and benefits of gene drives can be explored responsibly in laboratory
and field studies.”


Issue 607

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.