6 CRISPR critics have already begun to note the range of
risks to be considered and to consider how to fit CRISPR within existing
regulatory structures like the FDA or NIH.
7 Much conceptual work needs to
be done to properly assess the risks (or lack thereof) attendant on this
remarkable new genetic tool.
A REMARKABLE TOOL
A. The Technology
Genetic engineering holds great promise in treating disease and solving a
host of other problems. Editing genomes with molecular tools has been
possible for some time.
8 CRISPR, first described in a paper in 2012, turned
out to greatly advance the research tools available for genetic research.
advantages have become clear — it is easy to use, low in cost, and a more
precise tool for genetic engineering than earlier tools.
10 It is a gene splicing
tool that involves modifying an organism’s genetic material to alter or
improve its characteristics.”
11 CRISPRs are part of the bacterial immune
system that defends against invading viruses; they are repeating sequences of
genetic code, interrupted by ‘spacer’ sequences the cell uses to detect and
6. See generally SHELDON KRIMSKY, GENETIC ALCHEMY: THE SOCIAL HISTORY OF THE
RECOMBINANT DNA CONTROVERSY (1982) (discussing the political and social history of the
controversy); see also Judith P. Swazey et al., Risks and Benefits, Rights and Responsibilities:
A History of the Recombinant DNA Research Controversy,
51 S. CAL. L. REV. 1019 (1978)
(detailing the legislative proposals to regulate rDNA research); see also Barbara J. Culliton,
Recombinant DNA Bills Derailed: Congress Still Trying to Pass a Law, 199 SCI. 274 (1978)
(examining the legislative bills).
7. Sheila Jasanoff et al., Human Genetic Engineering Demands More Than A
Moratorium, GUARDIAN (Apr. 7, 2015), https://www.theguardian.com/science/political-
[hereinafter Demands]; see also generally Edward Lanphier et al., Comment, Don’t Edit the
Human Germ Line, 519 NATURE 410 (2015); see also Ledford, supra note 1; see also Sara
Reardon, NIH Reiterates Ban on Editing Human Embryo DNA, NATURE (Apr. 29, 2015),
generally Daniel Sarewitz, Comment, Science Can’t Solve It, 522 NATURE 413 (2015).
8. Ledford, supra note 1, at 21.
9. See Giedrius Gasiunasa et al., Cas9–crRNA Ribonucleoprotein Complex Mediates
Specific DNA Cleavage for Adaptive Immunity in Bacteria, 109 PROC. NAT’L ACAD. SCI.
15539, 15539–40 (2012), http://www.pnas.org/content/109/39/E2579/1.full; see also CRISPR
Timeline, BROAD INSTITUTE
spotlight/crispr-timeline (last visited April 17, 2017) (providing a full timeline); see also
Raheleh Heidari et al., CRISPR and the Rebirth of Synthetic Biology, SCI. & ENG. ETHICS (June
20, 2016), https://www.researchgate.net/publication/304171372_
10. See Michael Specter, The Gene Hackers, NEW YORKER (Nov. 16, 2015),l
http://www.newyorker.com/magazine/2015/11/16/the-gene-hackers (“CRISPR has made a
difficult process cheap and reliable. It’s incredibly precise.”).