with devastating effects.
59 Diseases could be created—engineered pathogens
could sicken or even kill thousands.”
60 Some of these concerns require a halt
to practical use of the CRISPR tool until the ecosystem risks are properly
assessed. Bioterror uses fall under the purview of military assessment, which
may be quite capable of evaluating and blocking some uses.
61 The problem
is always one of uncertain risks at the beginning of the spread of new tools
Gene drives create a wide range of risks.
62 Targeting wild organisms
requires understanding population dynamics and how to maintain stability.
Second, alterations could spread to nontarget or related populations.
are the unintended side effects?
65 Can drive capabilities occur in populations
not originally targeted?
66 Third, could populations of agricultural plants or
livestock be harmed intentionally by bad actors?
67 While this may be difficult
in industrialized farming, it is more possible in developing countries.
risk is less for altering human populations because of long generation times.
Oye et al. recommend a set of risk management steps to protect against
gene drive hazards.
70 Current regulation of gene drives rely on approaches
such as “listed-agent-and-toxin approaches,” neither of which really cover
the attributes of gene drive risks.
71 Likewise, U.S. environment regulations
for animal applications are ambiguous; international environmental
conventions fail to define the standard for assessing effects or mitigating
harms; and U.S. security policies fail to cover gene drives within the scope
of the oversight by Dual Use of Research of Concern (DURC).
International security conventions rely on narrow lists and fail to address
gene drive risks, and the authors note that “[g]ene drives and most other
advanced applications of genomic engineering do not use proscribed agents
or create regulated toxins and hence fall beyond the scope of operational
59. See id.
61. See id. (suggesting international laws and treaties that currently govern terrorism and
bioterrorism should incorporate misuse of synthetic biology).
62. See generally Oye et al., supra note 50.
63. Id. at 626–27.
64. Id. at 627.
68. See id. (explaining that “[d]eveloping countries that do not use centralized seed
production and artificial insemination could be more vulnerable.”).