RegulationofSyntheticBiology

OpalDillard
March10,2015
RegulationofSyntheticbiology
Syntheticbiologyisstillarelativelynewscienceandeventhoughwehavebeen
experimentingwiththegeneticsofbiologicalorganismsfordecadesitcanbesaidthat
westillhaveasmallunderstandingofthem.Accordingtothearticle,
TheEthicsof
SyntheticBiology:NextstepsandPriorQuestions
,Syntheticbiologyisnotjustaltering
biologicalsystemsbutitisattemptingtodevelopandemploystrategiesfordoingsothat
makepossibletherationaldesignandsynthesisofbiologicalsystemsthatservehuman
ends.Itbasicallytakestheideathatorganismsarebiologicalmachinesandwecangive
andtakeparts,intheformofDNAandproteins,thatwouldchangeitscharacteristic/
characteristicsinsomeway.However,organismsaremuchmorecomplexthanany
manmademachine.Thatiswhysyntheticbiologistsdontcreatepartsbutrather
repurposethem.Currentlyitsgoalistobeabletomakeengineeringbiologyeasier.
Eventhiscanposeachallengeandrequiresmuchtrialanderror,likeinthecaseofthe
basicdesignofthetoggleswitch....Thebasicdesignofthetoggleswitch,forinstance,
followedacomputationalmodelthatCollinsslabhaddevelopedpriortobeginning
experiments,butitneverthelesstookseveralmonthsoftrialanderrortotunetheswitch
sothatonegenedidnotoverpowertheother.Buildingabiologicalcircuitremainsa
muchmoreuncertainendeavorthanbuildingitselectroniccounterpart.(Xue,2014).A
projectthathasbeengoingonthatishelpingtodevelopastandardizedformofDNAis
theiGEM(internationalgeneticallyengineeredmachine)competition.Inthis

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competitionhighschoolandcollegestudentscompeteinengineeringbiology.The
studentsengineerDNAintotheformofBioBricks,thatarepiecesofDNAdesignedto
bemixedandmatchedatwill.EachBioBrickrepresentsasinglecharacteristicthatcan
beaddedormodifiedonanorganism.
Intheoryreengineeringcouldbeappliedtocomplexorganismsbutasoftodayit
ismostlylimitedtosinglecelledconstructs(Kaebnicketal.,2014).Eventhoughitis
onlypossibleonasmallscalenowthepossibilitiesforthebiotechnologyofthefuture
willbeIimagineimpressive.Syntheticbiologyprovidesustheopportunitytotransform
modernmedicine,generatecleanfuels,andpromotemoresustainableinfrastructures.
Forexample,oneoftheteamsfromtheiGEMcompetitionin2009tookE.Coliand
insertedcolorproducinggenes,thatallowedfortheE.Colitoappearinadifferentcolor
whenastimuliwassensedinitsenvironment.WiththiscolorchangingE.Coliitwould
bepossibletoputitinprobioticyogurtthatcouldmonitorhumandiseasewhiletraveling
throughthegut,andwhenatoxinordiseaseisdetecteditwillcomeoutacertaincolor.
Oritalsomightbepossibleformicrobesintheairtochangecolortoindicateairquality
(Xue,2014).Itisalsothoughtthatbiodiversitylosscouldbepreventedorfixedwith
syntheticbiology,becausewewouldbeabletobringbackanimalsthathavegone
extinct,orpossiblyprotectthoseendangeredbygivingthemtraitsthatwouldallowfor
themtoadapttoachangingenvironment.Thesamecouldbesaidforushumansas
well,asourenvironmentchangesfromglobalwarming,anddiseasesevolve,itwould
bepossibleforustochangeourtraitstoadapt.However,thiswouldbeinthefar
future.Theethicalissueisifweshouldcrossthatthresholdofnaturaltoengineered

RegulationofSyntheticBiology

needstobeaddressedbeforethatcanhappen.Fromsomereligiousviewsthiscould
beregardedasplayinggodbycreatingnewcreatures,ortoothersitcouldbethatits
unethicaltocreatebiologicalcreaturesthatcouldendupharmingpeopleorthe
environment.Forexampleiftheknowledgeofhowtocreateamoredangerousstrain
ofacertainvirusweretocomeout,wouldthatnotbeunethical?Thereisalsothe
ethicalissueoftestingandhowitisconducted.Ifsomeoneweretobegintomodify
humanswithoutfirstunderstandingwhattheriskscouldbe,wouldthatnotbeunethical
aswell?Butallofthisseemsunlikelyandprobablywillnothappenanytimesoon.
Amorepressingandcurrentissuewouldbetherisksthisscienceposesandthe
regulationthatshouldalongwithit.Thelongtermimplicationsofsyntheticbiology
include,ifsomethingthathasbeengeneticallymodifiedbecomesaninvasivespecies,
oritsgenesbecometoostrongaffectingbiodiversity,oritbecomesdangerousfor
humansinsomeway.Safetyandsecurityaretwomainconcernsthatwouldneedtobe
consideredinmakingregulationsforsyntheticbiology.
Oneofthemostdisquietingactsofwholescalebiologicalrecreation
camein2002,whenresearcherswereabletoproducelive,infectiouspoliovirus
bysynthesizingitsgenome.In2005,researchersattheCentersforDisease
ControlandPreventionusedsimilarmethodstoreconstructthevirusresponsible
forthe1918pandemicofSpanishflu.In2006,usingprivateaddressesand
identities,reportersfromTheGuardianwereabletomailorderasmallsegment
ofthesmallpoxgenome,thoughadditionalequipmentandexpertisewouldhave

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beenrequiredtoassembletheentiregenomeandbringthevirustolife.(Xue,
2014).
Ifgeneticengineeringbecamesimpleenoughforsomeonetomessaroundwithat
home,whostosaytheywonttrytocreateadeadlyvirusintheirbasement.Orlikein
TheWindupGirl
byPaoloBacigalupi,themodificationoforganismsleadstonew
diseasesincropandpeoplethatarehardertocontrol,orahousepetismodifiedand
becomesapest.Policymakersandscientistsalikeneedtobeabletocloselyexamine
therisksandopportunitiesofthefield.
GeorgeChurchslabworksactivelyonbothbuildingandtestingthebiological
safetyfeatures,whichmightbedesignedintofuturechassisorganisms.Heclaimsthat
theyarebuildingbiologicallymodifiedorganismsthatcantescapeandcantinfluence
ecosystemsbecausetheyaregeneticallyandmetabolicallyisolated.HislabsrE.Coli
isunabletolivemorethanafewminuteswithoutacompoundthatisonlyavailablein
hislab,andtheirbuildingorganismsthatcantusenaturalDNAfromtheirenvironment.
JamesCollinslabhassuggestedanalternativesolutionofdevelopingakillswitch
thatrespondstocertainchemicalsbyproducingtoxicproteinsthatkillthecell(Xue,
2014).However,thesearedifferentfromregulations.Commentatorwhohave
addressedthebiosecurityconcernshaverecommendedacombinationofprofessional
selfmonitoring,governmentaloversight,andresearchintotechnicaladvancesthat
couldpromotesecurityandsafety.Peacefulapplicationsalsoneedstudy(Kaebnicket
al.,2014).Transparencyisneededabouttheresearchandpotentialapplicationsand
investigatingthepossiblebenefitsandharmrequiresabroaddisciplinaryarrayof

RegulationofSyntheticBiology

experts.Investigationmustoccurovertimebecausewhatislearnedmightdrive
changeintheunderstandingofeventualoutcomes.Technologyhasprovento
inevitablychangeovertimeandsoaccordingly,bothinvestigationofoutcomesandthe
regulatorymechanismsputinplacetocontrolthemwillneedtobeflexible(Kaebnicket
al.,2014).
Ifregulationistobemadeitwouldneedtobebythoseknowledgeableinthe
subject,aswellasthosewhoareawareofpublicopinionsonthematter.Ifthepublic
opinionistohaveanyeffectonpolicy,thatmeansthepublicshouldhavesomeideaof
whatsyntheticbiologyisandwhattheopportunitiesthatcomewithbiotechnology,as
wellastherisksthatcomewithit.Theissuethatariseswiththisnotionishowtoinform
peopleonsyntheticbiologyandhowtodistributeandpresenttheinformationtothe
masses.Accordingtothearticle
PublicUnderstandingofSyntheticBiology
byEleonore
pauwels(2013),thenumberofpeoplewhoareawareofsyntheticbiologyhasincreased
buttheyareoftennotfullyinformed.Thosewhoareforit,findthatregulationis
importantafterlearningmoreaboutit.Whilethoseagainstitchangedtheirmindsabout
itafterbeingmoreinformed.Theidealsituationinmyopinionwouldbeabletogive
informationthroughthemediathatisunbiasedandstrictlyinformativeinordertoallow
peopletoformtheirownopinions.Thereasonbehindthisthinkingisthatinourcurrent
societyeveryoneisconstantlyintouchwiththemedia,whetheritbeonacomputer,TV,
tablet,orcellphone.Butwithourmediaandthetopicitself,anunbiasedwayof
informingpeopleseemsnearlyimpossible.

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Whenrevisionsonthecurrentregulationoccursitwillneedtobeinaframework
thatcaneasilybeappliedtoanycurrentandfutureproblemsthatmayarise,andbe
flexibleenoughtochangetoarapidlygrowingfield.Thisframeworkwillalsoneedto
notinhibitintellectualinquiryandscientificfreedomandbenefits.Regulationswould
alsoneedtoaddressanyethicalissuesthatmayarise.Theultimategoalofregulation
wouldbetomaximizebenefitandminimizedangers.Scientiststendtosupport
selfgovernanceorbottomupgovernanceandnonbindinglegislativeframework.Many
alsobelievethatscienceshouldbepoliticallyautonomousandthatselfgovernanceis
essentialtothenatureandprogressofscience.Thoseagainstselfgovernanceargue
thattherisksofsyntheticbiologyareprofoundandhaveanimpactonbothsocietyand
theenvironment,andthatresearchandresearchersshouldbetightlyregulated,and
supporttopdowngovernanceofresearchandpublicationpractices(Samueletal.,
2009).Theissuethatlieswithinregulationisthatnotenoughoftherisksandbenefits
areunderstoodcurrentlytomakepermanentregulations.Thereisaneedtoallow
flexibilityinregulationtoallowscientiststofiguretheseout,withoutdoingsoitcould
slowdownthepossiblebenefitsofthefieldandinhibitfurtherresearch.

References

GregoryE.Kaebnick,MichaelK.Gusmano,andThomasH.Murray.Theethicsof
syntheticbiology:Nextstepsandpriorquestions.Hastingscenterreport.
NovemberDecember,2014.
KatherineXue.SyntheticBiologysNewMenagerie.HarvardMagazine.
SeptemberOctober,2014.

EleonorePauwels.PublicUnderstandingofSyntheticBiology.BioScience.February,
2013.

RegulationofSyntheticBiology

GabrielleN.Samuel,MichaelJ.Selgelid,andIanKerridge.Managingthe
unimaginable:Regulatoryresponsestothechallengesposedbysynthetic
biologyandsyntheticgenomics.EMBOReports.2009.