Genome Editing and Biological Weapons: Assessing the Risk of Misuse

281 Pages·2022·6.775 MB·English

by  Katherine Paris

Katherine Paris
Genome
Editing and
Biological
Weapons
Assessing the Risk of Misuse
Genome Editing and Biological Weapons
Katherine Paris
Genome Editing
and Biological Weapons
Assessing the Risk of Misuse
KatherineParis
GeorgeMasonUniversity
Arlington,VA,USA
ISBN978-3-031-21819-4 ISBN978-3-031-21820-0 (eBook)
https://doi.org/10.1007/978-3-031-21820-0
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Foreword
On November 25, 2018, an obscure Chinese scientist surprised the scientific com-
munitybyannouncingthathehadusedanewgenomeeditingtooltosecretlycreate
the world’s first genetically engineered babies. Dr. He Jiankui, based at Southern
University of Science and Technology in Shenzhen, China, had used a relatively
newtechnologycalledCRISPRtomodifythegenomeoftwobabies,whowereborn
shortlybeforehisannouncement,inanattempttoreducetheirsusceptibilitytoHIV.
Dr.He’srevelationdominatedtheSecondInternationalSummitonHumanGenome
EditingattheUniversityofHongKongwhichstartedafewdayslater.Thedebate
overthescientificapplications andethicalimplicationsofhumangermlineediting,
which had accelerated in recent years as the potential power of CRISPR became
moreevident,wasnolongerabstractorhypothetical.
As the global community was wrestling with the profound ethical questions
raised by He’s experiments, I was preparing for the release of a new report on a
different dimension of genome editing: biosecurity. With my colleagues Dr. Jesse
Kirkpatrick at George Mason University and Dr. Megan Palmer and Dr. David
Relman at Stanford University, we were at theend of a 2-year project to study the
risks that genome editing could be misused to cause harm and provide recommen-
dations for strengthening governance of this dual-use technology. Our report,
EditingBiosecurity:NeedsandStrategiesforGoverningGenomeEditing,identified
a range of risks posed by genome editing including dual-use risks posed by the
creationofnewtoolsandknowledgethatcouldbemisusedtocauseharm,biosafety
risks presented by novel types of edited organisms, reckless applications that take
advantage of regulatory loopholes, and the threat posed by actors who seek to use
this emerging biotechnology for malicious purposes. We also described how the
emergence of genome editing had disrupted the biosecurity landscape and chal-
lengedourtraditionalapproachtoassessingandmanagingbiologicalrisks.
Akeytake-awayfromourreportwastheneedto“takethetechnologyseriously”
when assessing the risks and benefits of genome editing technologies such as
CRISPR. In the conclusion, we wrote, “A thorough, informed, and accessible
analysis of a given technology and its social context is crucial to considering the
v
vi Foreword
impact that it may have on the security landscape...Absent such detailed analyses,
actors may issue pronouncements of risk and impact that are based on unfounded
assumptions,whichcanstraincredibility,puttingstakeholdersinapoorpositionto
assesstheveracityoftheseclaims....Oftenthekeyactorsbestequippedtoprovide
analyses of what is possible and plausible are those who work closely with the
technology.Inaddition,thoseclosesttothescienceandthevarietyofapplicationsin
different domainscanhelpcapturekeytrends.Engagingtechnologistsinsustained
dialoguewithsocialscientistsandpolicymakerscanilluminatethesecurity-related
aspects of these trends that may be less salient at the ground level, while also
equippingtechnologiststoappreciateandhelpundertakegovernanceactions.”1
Inthisbook,Dr.KatherineParisdeliversthe“thorough,informed,andaccessible
analysis”ofgenomeeditingtechnologiesthatwecalledforinour2018report.With
degrees in biology, biotechnology, and biodefense, Dr. Paris is well equipped to
understandthestrengthsandlimitationsofthegenomeeditingtechnologiesthatshe
writesabout.Justasimportant,sheisabletoconveyheranalysisofthese technol-
ogies with enough clarity for a lay audience and enough sophistication for a
scientificreader.Furthermore,heranalysisisenlivened byherpersonalexperience
learninghowtouseCRISPRatacommunitylabassociatedwiththeDo-It-Yourself
(DIY)biologymovement.Sincesomeofthemorealarmistanalysesofthedangers
posedbygenomeeditingrevolvearoundmisuseenabledbytheDIYcommunity,her
first-hand observations help provide important perspective on the potential for
misuse by non-traditional practitioners of the life sciences. As befits a scholar
workingattheintersectionofscienceandsecurity,Dr.Paris’workischaracterized
byarigorousandevidence-basedassessmentoftherisksposedbygenomeediting
technologies. Her analysis of the opportunities presented by genome editing for
creatingnewandimprovedbiologicalweaponsisbalancedwithanevaluationofthe
obstaclestoachievingthosenefariousobjectives.Inkeepingwiththephilosophyof
the Biodefense PhD program from which she graduated (and I direct), Dr. Paris
bridges the gap between the scientific and policy communities by offering cogent
policy recommendations to prevent and mitigate the misuse of genome editing
technologies.
Aswith recombinantDNAinthe1970sandsyntheticbiologyinthe2000s,the
emergence of genome editing technologies, especially CRISPR, has raised hopes
and fears about its impact on science, public health, medicine, the economy, and
society.Althoughmanyoftherisksandrewardsunderdiscussiontodayarethesame
ones featured during previous debates about breakthrough biotechnologies, the
current debate needs to take into account not only the distinctive characteristics of
genome editing technologies, but also the recent developments in the political,
security, economic, and technological domains that influence the development,
1JesseKirkpatrick,GregoryD.Koblentz,MeganJ.Palmer,EdwardPerello,DavidA.Relman,and
SarahW.Denton,EditingBiosecurity:NeedsandStrategiesforGovernanceofGenomeEditing
(Arlington,VAandPaloAlto,CA:GeorgeMasonUniversityandStanfordUniversity,2018),81.
https://doi.org/10.13021/mxmm-kn14
Foreword vii
diffusion, and applications of this powerful dual-use technology. Dr. Paris has
providedthetypeofrigorous,multidisciplinaryanalysisthatthescientificandpolicy
communities need to navigate the increasingly dynamic and complex global
biosecuritylandscapeusheredinbytheadventofgenomeediting.
Director,BiodefenseGraduateProgram, GregoryD.KoblentzPhD,MPP
ScharSchoolofPolicyandGovernment,
GeorgeMasonUniversity,Arlington,
VA,USA
May2022
Acknowledgements
This book was made possible through the support and encouragement of many
people. Thank you, Dr. Gregory Koblentz, for inspiring me to research advance-
ments in genome editing technologies and the implications on biodefense and
biosecurity.Iamgratefulforyourhelpthroughouttheresearch,writing,andreview
process.IwouldalsoliketothankDr.JamesConantandDr.KyleneKehn-Hallfor
theirguidanceandhelpfulfeedback.Isincerelyappreciatethetimethatyoualltook
toadviseme.
Iapproachedtheassessmentoftheriskofmisuseofgenomeeditingtechnologies
through a biosocial frame. This method of study would not have been possible
without the hands-on experience and observations that I acquired while working
with CRISPR at Genspace, a DIY bio laboratory in Brooklyn, New York. The
generous support of the George Mason University Schar School of Policy and
GovernmentStudentResearchGrantmadeitpossibleformetoattendtheGenome
EditingwithCRISPR-Cas9class.ManythankstoeveryoneatGenspaceforsharing
yourexpertiseinCRISPRandDIYbio.
SpecialthankstothenonprofitplasmidrepositoryAddgeneanditsdatacollection
team in Watertown, Massachusetts for assembling and providing me data on the
ZFN,TALEN,andCRISPRkitsthatAddgenereceivesandsendsallovertheworld.
Thisdatamadeitpossibletoassesstheavailabilityofgenomeeditingtechnologies
moreaccurately.
Finally, my sincere thanks for the unwavering support that I received from my
family,friends,andConstantine.
ix
About the Book
In February 2016, Director of National Intelligence James R. Clapper issued a
serious warning over the threat that genome editing poses to the national security
of the USA in the annual Worldwide Threat Assessment of the United States
Intelligence Community. This threat assessment, which was delivered to Congress,
cautioned that genome editing could be misused deliberately or unintentionally to
create harmful biological agents or products. The explosion in popularity of a
genomeeditingtechnologycalledclusteredregularlyinterspacedshortpalindromic
repeat (CRISPR) coincided with the release of the 2016 threat assessment. Unlike
earliergenomeeditingtechnologies—namely,zinc-fingernuclease(ZFN)andtran-
scriptionactivator-likeeffectornuclease(TALEN)—itdidnottakelongforCRISPR
tospreadandbecomeacommonlyusedtechnologyinlaboratoriesaroundtheworld.
Genomeeditingtechnologiesallowfortheprecisegeneticmodificationoforgan-
ismsandculturedcells.Whilethesetechnologiesareusedforavarietyofbeneficial
applicationsfrombasicresearchtobiotechnology,agriculture,andmedicine,experts
cautionthatZFN,TALEN,and,particularly,CRISPRcouldbemisusedtodevelop
new and improved biological weapons. Policymakers are faced with the ultimate
challenge of protecting and safeguarding the continued development and use of
genome editing for legitimate purposes, while putting in place biodefense and
biosecurity strategies to prevent misuse. Prior to determining what type of gover-
nance measures would be effective in preventing misuse, it is critical to conduct a
technology assessment that considers both the risk of misuse and the level of
governabilityofgenomeeditingtechnologies.
In Genome Editing and Biological Weapons: Assessing the Risk of Misuse,
Katherine Paris provides a comprehensive assessment of the actual risk of misuse
ofZFN,TALEN,andCRISPR.Parisconductstheassessmentoftheriskofmisuse
by applying Jonathan B. Tucker’s Decision Framework for Governance of Dual-
Use Technologies. She investigates the accessibility, ease of misuse, magnitude of
potentialharm,andimminenceofpotentialmisuseofgenomeeditingtechnologies.
Toavoidrepeatingtheshortcomingsofthepastbiothreatassessments,Parisapplies
abiosocialframe,insteadofatraditionalbiotechrevolutionframe,tobetteraccount
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xii AbouttheBook
for the contingencies and complexities involved in biological weapons work. She
concludeswithanassessmentofgovernabilityandatailoredsetofrecommendations
that address security concerns. These recommendations are sensitive to the cost-
benefittrade-offofregulatinggenomeeditingtechnologies.Thebookisamust-read
forpolicymakers,defenseandsecuritypersonnel,andintelligenceanalysts.