The Realness of Risk

The Realness of Risk: Gene Technology in Germany
Author(s): Rosemary Robins

Source: Social Studies of Science, Vol. 32, No. 1 (Feb., 2002), pp. 7-35
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Sss
ABSTRACTThispaperexaminesthe materialrelationsof riskwithina disputeabout
the hazardsof manufacturing humaninsulinusinggene technology, and the r6le
playedbythe referent 'real risk'inthe technicalperformance of riskinthatdispute.
Itdrawson recentworkin scienceand technologystudiesthatextendsactor-network
theoryto examinethe performance of realityin scientific
practice.The multiplicity
of
risksinthe dispute,and the linksmade and unmadebetweenthem,are examined.
I arguethatinthe dispute,riskswerecontingently linkedand separatedarounda
referent 'real risk'thatemergedwithinthe recombinant DNAdebate of the late
1970s.I contrastmyaccountof riskwithrealistand relativist accounts,each of which
valuesriskas an abstractentity.In myaccount,risk'svalue is contingentupon sets
of materialrelationsthatlinkhazardsand proceduresfortheirminimization. Risk's
realnessemergesas some risksare linkedand othersseparated,workinga
multiple/singular relationin an ontologicalpoliticsof risk.
Keywords actor-network
theory,Hoechst,humaninsulin,realism,recombinant
DNA
debate, relativism
The Realness of Risk:

Gene Technologyin Germany
Rosemary Robins
This paper investigatesthe materialrelationsof riskwithina disputeabout

the hazards of manufacturing human insulinusinggene technology.Addi-
tionally,it asks what role the referent'real risk' plays in the technical
performanceof riskthattook place in the dispute.The antagonistsin this
dispute were the pharmaceuticalcompany Hoechst, who proposed the
human insulinfacility,and a groupof citizenswho residednear the site of
the proposed facilityand were opposed to it. Each talked about 'risk' as
potentialhazards associated with the use of gene technologyto manu-
facturehuman insulin,set in relationto variousproceduresand practices
forminimizingor avertingthose hazards. Differentsets of materialrela-
tions performeddifferent risks.There were, in this sense, multiplerisks,
and the disputewas about how these different riskswere eitherlinked,or
separated,or perhaps linked in some ways and separatedin others.' As
withmost disputes,the debate about riskwas part of a broader struggle
over social and political priorities.However, this broader strugglenar-
rowedto specificlocationsin thefacilityas the actors'concernsfocusedon
the technical aspects of risk assessment.In this paper, I focus on this
Social StudiesofScience32/1(February2002) 7-35

? SSS and SAGE Publications(London, Thousand Oaks CA, New Delhi)
[0306-3127(200202)32:1;7-35;024024]

8 Social Studies of Science 32/1
narrowtechnicalphase as the locationwithinwhichdifferent risksof the

insulinfacilityemerged.
One of the motivationsforthispaper is an attemptto reconciletwo
apparentlyincommensurableaccounts of the ontologyof risk:realistrisk,
where risk is determinedby nature, and relativistrisk, where risk is
generatedwithinsocial institutions. We mightunderstandthe formeras
claimingriskas a naturalobject and hence real, and the latteras having
risk as a social object. The latter,in seeing risk as generatedin social
institutions,understandsit as relativeto thoseinstitutions. Both agreethat
risk is an abstractentity:a way of identifying a set of causal relations
between thingsin the world, which are the consequence of particular
technical contrivances.For both realistsand relativists,risk exists 'out
there'as the subjectof quantifying generalizationsrepresentedas number
or as ratio.For therealist,thereis onlyone valid quantifying generalization
of a set of causal relations:hence risk has a single ascertainablevalue.
Relativistsmaintainthatmanyvalid interpretations of the causal relations
are possible: forthem,riskis plural.As theysee it, the value or extentof
riskis relativeto social institutionswhichmake up different, but equally
valid, quantifying generalizationsabout the consequences of a single set
of technicalcontrivances.In my account, risk is configuredmateriality.
Humans and their institutionsfigureas much as thingsin the world
in generatingand maintainingrisks. Risks continue to be generatively
(re)performed in the presentas long as associationshold.2In myaccount,
risksare neithersingularnor plural- theyare multiple.Here the general-
izingthatvalues riskmustbe understoodnot as abstractgeneralizing,but
as generalizingcontingently linkedto ordersand orderingsof humansand
non-humansin a microworld,3 which in this case is the human insulin
facility.Understandingriskin thisway,as a materiallycontingentreality,
avoids the need to distinguishbetweenrealistand relativist risk.
This distinction(between realistand relativistrisk) is one that has
been widely maintainedin the risk literature.Risk assessmentmodels
typicallyembed a realistontologyof risk- one thatis independentfrom
the procedureswe use to assess it. Risk assessmentis portrayedas a pro-
cedurethatenablesus to knowwhattheriskis, whereriskis generalizedas
the probabilityof a particularharm occurringand the magnitudeof that
harm. For example,the UK Royal Society Study Group on riskdefined
environmental riskas:
A measure of potentialthreatsto the environment which combines the
probabilitythateventswill cause or lead to degradationof the environ-
mentand the severityof thatdegradation.4
riskis knownthroughthe act of measuringthe potential

In thisdefinition,
for environmentaldegradationand the severityof that degradationfor
particulareventsor activities.The definitionseparatesthe ontologyof risk
fromits epistemologyby locatingriskindependentlyfromour abilityto
know it. Most practitionersof risk assessmentare comfortablewith this
realistontologyof risk.For example,one of the most widelyused models

Robins: The Realness of Risk: Gene Technologyin Germany 9
of risk assessmentwas that designed by the National Research Council

(NRC) in the United States.In thismodel,riskassessmentis themeans of
objectivelymeasuringrisk, and risk managementis a stage in the risk
analysisprocessthatincorporatessocial and politicalfactors.In theirReport
outliningtheprocedure,theNRC made thefollowingrecommendation:
Werecommend agenciestakestepsto establish

thatregulatory andmain-
taina clearand conceptualdistinction
betweenassessment of therisks
and considerationofriskmanagement thatis, thescientific
alternatives;
findingsand policyjudgementsembodiedin riskassessments shouldbe
explicitly fromthepolitical,economic,and technical
distinguished con-
thatinfluence
siderations thedesignand choiceofregulatorystrategies.5
This account of riskhas been widelychallengedby social scientistson

the basis that scientificdefinitionsof riskin such models are formulated
relativeto social frameworks that generallygo unacknowledgedand un-
examined. Social scientistsargue that risk is not somethingthat exists
independently fromour assessmentofit: rather,it is determinedrelativeto
the social institutionsand judgementsabout which hazards to focus on,
and when, and to whom, they mightbe acceptable. In such relativist
accounts,riskemergesnot as a consequence of some rationalchoice about
reality,but relativeto science and decision-makingwithinsocial institu-
tions. Sheldon Krimskysuggests,forinstance,thatif riskwere to have a
realistontologyit would have a metaphysicalstatusas a propertyof the
physicalworld that could be objectivelymeasured. However,he asks: 'is
theriskofsomethingan objectivemeasureofthatthing,or is it a subjective
value thatvaries accordingto context?'.6Krimskyis of the view thatthe
context in which risk is assessed is an importantdeterminantof the
outcome. Social and institutionalarrangements, world-views,and factors
such as trustand control,are all partofthe cultural/hermeneutic processes
fromwhich the riskis established.In relativistaccounts wherethe social
contextis privilegedas the shaperof content,riskis said to be constructed
and not 'real'.7
In thispaper, I uphold the view thatriskis real in the sense thatit is
embeddedin thematerialities of our worlds.However,I also recognizethe
significanceof it circulatingas a referent'real risk',8in contributing to the
outcome of disputes over risk. I will argue that the strongestreferent
'real risk'thatcirculatedin the Hoechst disputefirstemergedduringthe
recombinantDNA (rDNA) debate of the late 1970s and early 1980s. In
the dispute examinedhere, all actors treatedriskas the real potentialof
gene technologyto cause harm.They each invokeda referent 'real risk'in
orderingsome thingsin and othersout. Moreover,'real risk'was presented,
in each case, as having an ontologyindependentfromthe analyst or
perceiver.Wolfgangvan den Daele makes a similar observationin his
examinationof a case of participatory technologyassessmentin Germany,
in whichdifferent stakeholderscame togetherto discuss the risksof gene
technology.He notes that in the practiceof risk assessment,the natural
worldis takenas real and scientific factsare used as a means ofjudgingthe

validityof claims individualsmake about hazards. All the participantsin

thecase he examined'proceededfromtheassumptionthatthereis a reality
"out there"thatcan be recognizedin principle,and thattruthcan be more
or less distinguishedfromerror'.9Constructivist philosophies,he points
out, played no role in the process of technologyassessment.Van den
Daele's pointis thatwhilea philosophicalcommitment to the construction
of realitymay be of theoreticalinterest,in practice people act on the
certainty thattheirworldsare real. For mypurposes,thisfocuson practice
is instructivebecause it suggeststhat if we want to understandrisk's
realness,it is not sufficient
to treatrealityas redundant,or as a modernist
mythin need of deconstruction.Moreover,it does not necessarilyfollow
thatif one attendsto the role of realityin riskassessment,one needs to
adopt a realistversionof risk. Quite the contrary:the dilemma presents
itselfas an opportunity to analysethe materiality ofrisk'srealness,and the
role playedby the referent of realityin negotiationsoverrisk.
This brings me to the second motivationfor this study.I see an
analysisofthe ontologyofriskas a contribution to workin thesociologyof
science and technologythatdeals withthe ontologyof realityin scientific
practices.'0Instead of startingwiththe objects of reality(such as factsor
thingsin nature)and askinghow theyare known,thisapproachbeginsby
lookingat relationsformedin the practicesthroughwhichfactsand things
in natureare made to belong to the real. The focus is on the practiceof
doing science, on the makingof relationsand connectionsfromwhich
claims about realityand objects of realityemerge. The focus is also
ontologicalin thatit asks how thingsare made to belongto the real,rather
than askingthe epistemologicalquestion of how we knowthingsare real.
JohnLaw and AnnemarieMol have describedthisas a focuson the'doing'
of realitythattheycall 'ontologicalpolitics'.As Mol puts it:
Ontologicalpoliticsis a compositeterm.It talksofontology- whichin
standardphilosophical parlancedefineswhatbelongsto the real,the
conditionsofpossibility is combined
we livewith.If theterm'ontology'
withthatof'politics'thenthissuggests thattheconditionsofpossibility
are not given.That realitydoes not precedethemundanepracticesin
whichwe interactwithit,butis rather shapedwithinthesepractices.
So
the termpoliticsworksto underlinethisactivemode,thisprocessof
shaping,andthefactthatitscharacter is bothopenand contested.11
In extendingthis approach to risk,I will examine the realityof risk as
performedwithin the practice of risk assessment. In doing so, I will
examine how risk achieves its realness as a consequence of the material
'real risk'guides the
relationsin whichit is located, and how the referent
processwithinwhichthose relationsare made. The issues I confronthere
in relationto risk are similarto those examinedby Helen Verranin her
critiqueof 'foundationiststories'of number.Verran'salternativetellingof
number looks to practices where number is done and within which
number'srealness'clots':
storiesexplainentitieslikenumberas determined
Whilefoundationist
orbya socialpast(relativism),
bynature(universalism)
either I suggested

inGermany
Robins:TheRealnessofRisk:GeneTechnology 11
thatstoriesexpressing
thisalternative
framingwouldexplainwhatnum-
bersarein termsofhere-and-now routines
ofpractice,
ongoingcollective
acting.
12
In this paper I explain risk's realness 'in terms of here-and-now

routinesofpractice'thatmade up themateriality ofriskin the disputeover
Hoechst's human insulin facility.In what follows,I firstdescribe the
procedureused by Hoechst to manufacturehuman insulin(in particular,
the use of gene technology)so as to identifythe components of the
procedure that were centralto the technical debate about risk. I then
examine the emergenceof the circulatingreferent'real risk' withinthe
rDNA debate. The importanceof this referentin the Hoechst case is
examinednext,as I tellofthedisputethatflaredup overthehumaninsulin
facility.My focus is specificallyon the technicaldetailsof the riskassess-
ment process. In earlierwork,I have examinedthe wider dimensionsof
this dispute.'3 Here I focus on a formalcase of opposition,known in
German as Widerspruch, which enabled citizens to present evidence of
hazards posed by the insulinfacility,additionalto thatalreadyconsidered
by local authorities.The empiricalevidence I draw upon is containedin
severaldocumentsthatset out thetechnicalworkingsof the facilityand its
risksfromthe viewpointof the citizens,Hoechst, and the local authority
responsibleformakinga finaldecision in the case. These documents,in
providingdetails of the risk assessmentprocess, enable me to trace the
multiplicityof risksthat emergedwithinthe technicaldimensionsof the
dispute and their circulating'real risk' referents.I examine the sets of
relationsmade by Hoechst, theiropponents and the local authorityto
orderthemicroworldofHoechst's humaninsulinproduction:humansand
non-humans in the architectureof the facility,potential hazards, and
proceduresfortheirminimization.I conclude the paper by makingsome
generalobservations:firstly,about thematerialrelationsand multiplicity of
riskin the dispute;secondly,about how the referent 'real risk'guided the
processofarticulating thosematerialrelations,and thelinksmade between
multiplerisks;and finally,about whatmightbe learnedfromthisprocess
about risk'srealness.
Hoechst's Procedure forManufacturingHuman Insulin

Human insulinis a hormoneproduced by the human body in the cells of
the pancreas, where it is essential for the metabolismof food and the
maintenanceofsafeblood sugarlevels.People who do not produce enough
insulin,or whosebodyhas troubleusingtheinsulintheydo produce,suffer
froma disease called Diabetes Mellitus. Diabetes occurs in two main
forms.Type I is the most severe,and usuallyaffectschildrenin theirearly
teens, is often referredto as 'insulin dependent diabetes', because in-
dividualswithType I depend on life-longinsulininjectionsto survive.Type
II is less severe.It tendsto affectolderpeople and lifestyle
factorssuch as
obesityand a diet high in refinedsugars contributeto its onset.Type II
diabetescan oftenbe controlledby a changein diet and weightreduction,

and only in the more severe cases is treatmentwith insulin necessary.

Diabetes has traditionally been treatedwithanimal insulinextractedfrom
bovine and porcine pancreatictissue. However, the techniques of gene
technologyenabled the manufactureof human insulinin quantitieslarge
enough to replace animal insulin as the main form of treatmentfor
diabetics.In 1982, Eli Lillymade historyby manufacturing human insulin
as the firstcommercialproductof gene technology.'4Hoechst, the major
supplierof insulin in Germany,followedLilly's lead and, in 1984, put
forwarda proposal to build a facilityto manufacturetheirown brand of
human insulin.
Hoechst's facilityhad three stages, called respectively'Fermtec',
'Chemtec' and 'Insultec'. The techniquesof gene technologywere used
onlyin the Fermtecstage,wherethe raw insulinproteinwas made, and it
is thisstage of the facilitythatis the focusof thispaper.The procedurein
Fermtecused a strainof the Escherichiacoli (E.colz) K12 bacteriumthat
had been geneticallymodifiedto containan insulingene and produce an
insulinprotein.The specificstrainofE.coli KI 2 used by Hoechstwas E. coli
W3 110. The insulingene insertedinto thishost had been cloned froma
meerkat(a small lemur-likemammal fromsouthernAfrica),and trans-
portedintothehostbacteriumon a smallcircularpiece of DNA knownas
a plasmid. Plasmids move easily in and out of bacteria, and are used
routinelyin gene technologyas vectorsforgeneticmaterial.In this case,
theplasmidused by Hoechst was called plasmidWH1 (pWH1), whichhad
been modifiedfromthe more commonlyused plasmid BR322 (pBR322).
The combinationof bacterialhost and plasmidvectoris knownas a 'host-
vectorsystem';in Hoechst's case, thehost-vector systemwas E. coliW3110
(pWH1). When grownin culture,the modifiedbacteriamultiplyto pro-
duce the insulin proteinencoded by the insertedgene as part of their
otherwisenormalfunction.15
In Fermtec,the proteinproduced in thisway consistedof two fused
elements: a pre-proinsulinprotein from the insulin gene and another
protein,routinelyproducedby theE. colibacterium,called]3-Galactosidase.
This fusion-protein was similarbut not identicalto human insulin,and
therefore needed severalfurther stagesof refinement,whichtook place in
the Chemtec and Insultec stages of the plant. In the Chemtec stage,the
dead bacteria were broken down and the fusion-proteinextracted.A
chemical process was then used to separate the J3-Galactosidase section
fromthe insulinprotein.In the finalInsultec stage, the insulinprotein
producedin Chemtecwas convertedintobiologicallyactivehumaninsulin,
and furtherrefinedto produce a highlypurifiedhuman insulinproduct
[HA, 6-8; DR, 22-26].16
In the above description,E.coli K12 bacteria,plasmids and the pro-
cedures of bacterial fermentationand protein extractionused to make
human insulinare importantcomponentsof gene technologyand, as we
shall see, they are equally implicatedin its risks.The hazards of gene
technologyhad been recognizedwellbeforeHoechstproposedtheirfacility,
and it was withinthe earlydebates about thistechnologythatentitiessuch

as E. coliKl 2 and plasmidstook shape as objectsof risk,as well as objects

of gene technology.The early articulationsof the relationshipbetween
hazardsand theirminimizationthattookplace duringtherDNA debate in
the United States, in the latterhalf of the 1970s and early 1980s, were
importantin shapingthe referent 'real risk'of gene technologyand, as we
shall see, this had importantimplicationsfor how risk emerged in the
Hoechst dispute.
Early Articulations of Risk

The concern that E.coli K12 bacteria might become hazardous when
geneticallymodifiedwith foreignDNA, became a centralfocus of the
rDNA debate.'7This debate was sparkedby the announcementof the first
successfulgene technologyexperiment, at the 1973 Gordon Conferencein
the United States. Concerns about the hazards posed by this technique
were heightenedby the factthatmuch of the researchbeing done at the
time focused on the role of genes and virusesin human cancer.This led
scientiststo impose a voluntarymoratoriumon certaingene technology
experimentswhile theyestablishedways to assess and manage the risks.
Since most of the experimentsproposed at the timeused E.coli K12 as a
host organism,the rDNA debate wenta long waytowardsestablishingthis
organismas an object of risk.
E.coli K12 is a bacteriumthat has been routinelyused in biological
researchsince the 1940s. Part of its appeal as a laboratoryworkhorseis
that K12 readilyexchangesgeneticmaterialwith othersof its kind in a
matingprocess called 'conjugation'.During the rDNA debate,E.coli K12
underwentsomethingof a re-birth.Gene technologyoffereda novel
approachto researchon human cancerviruses,and E. coliK1 2 became the
favouredhostforsuch work.Kl 2's fertility, theverythingthathad made it
a popular research tool, became a potential hazard when viral genes
thoughtto cause cancerwereengineeredintothisbacterialhost.What,for
instance,would be thehazardifmodifiedE. coliK1 2 bacteriawereto infect
the intestinaltractof humansworkingwithit?'8
During the rDNA debate, a substantialamount of attentionwas
devoted to this question. In the United States, at an early stage in the
debate, guidelinesregulatinggene technologywerewritten,and an expert
committeewas established,called the RecombinantDNA AdvisoryCom-
mittee.The workof thisCommitteewas to assess and manage the risksof
proposed gene technologyresearch in accordance with the guidelines,
which detailed criteriaforphysicallyand biologicallycontainingthe haz-
ards of different host-vectorsystemsused in gene technology.'Physical
containment'referredto the physicalspace in whichthe workwas to be
undertaken:to the design of that space, and the extent to which it
preventedhazardousbiologicalmaterialfromreachingtheoutsideenviron-
ment. There were four levels of physical containment,which in the
languageof theguidelineswerelabelled P1 forminimal,P2 forlow,P3 for

moderateand P4 forhigh. Each requiredincreasinglystringentcontain-

mentroutines.At a P1 levelof containment,forinstance,therewerefairly
standardroutinesof laboratoryhygiene,such as no eating,drinkingor
smoking.Laboratoryworkerswererequiredto wear lab-coatsat all times,
therewas to be no mouth-pipetting, and disinfectionfacilitieswere to be
readilyat hand. By comparison,the physicalfeaturesof a P4 facilitywere
stringent;theyincludedisolationof the area by air locks,withthe interior
environment undernegativepressureto preventthe movementof material
to the outside.Workerswererequiredto showerand changeclothesbefore
enteringand leavingthe workspaceand all waste was treatedto remove
contaminants.Anotherfeatureof physicalcontainmentin the earlyver-
sions of the guidelineswas a limitto 10 litreson the volume of bacterial
culturethatcould be used. The limitwas set because at thetimelaboratory
researchwas the onlyworkenvisagedand forthistypeofwork10 litresof
bacterialculturewas more thanadequate. It was also a volumethatcould
be easily contained; however,largervolumes could be approved by the
advisory committee on a case-by-case basis. 'Biological containment'
referredto the relativefragilityof the host organismsand vectorsused in
the work.If thesetwo componentsof rDNA workwereweakened,so that
they could not surviveoutside the rarifiedconditionsof the laboratory
or facilityin which theywere used, theywere said to offera degree of
biologicalcontainmentrelativeto theirfragility.The greaterthe fragilityof
the host-vectorsystem,the more robustits containment.The guidelines
describedthreecategoriesofhost-vector systems,whichofferedlow [EK1],
moderate[EK2] and high [EK3] levelsofbiologicalcontainment.19
During the rDNA debate, it was proposed that geneticallymodified
E.coli K12 bacteria may be potentiallyhazardous when used as host
organismsforforeigngenes,ifthe bacteriaare able to surviveoutside the
laboratoryin such places as the human or animal intestine,or in soil and
water.This potentialforhazard arose because E. colibacteriaare a normal
part of the intestinalfloraof humans and animals and it was possible, if
geneticallymodifiedKl 2 wereto finditswayintotheseenvironments, that
theycould survive,transfer the foreignDNA to othermicroorganisms and
become a hazard.Riskassessmentexperiments wereperformedduringand
followingthe rDNA debate in an effortto determinethe probabilityof
such colonization and hazard occurring.The evidence generatedfrom
theseexperiments was used to supportwhatemergedas the majorityview
among molecularbiologistsof the day thatE. coliK1 2 did not survivewell
outsidelaboratoryconditions.Concern about the riskposed by E. coliK12
also led scientiststo develop new and more enfeebled strains of the
bacterium,as well as so-called 'safetyplasmids', which are plasmids that
have been modifiedin certainwaysto impedetheirabilityto transfer DNA
to othermicroorganisms.
As data weregeneratedand linkedto potentialhazardsassociatedwith
the use of F.coli K12 in gene technology,relationshipsbetweenhazards
and proceduresfortheirminimizationwere articulated.As new data were
generated,additional links were made and othersunmade. From these

Robins:The Realness of Risk: Gene Technologyin Germany 15
associations,the referent'real risk' of gene technologyemerged. It was

inscribedin the guidelines,and reinscribedin subsequentrevisions.In the
firstversion(publishedin 1976), E.coli K12/plasmidhost-vectorsystems
were givenclassifications rangingfromEKI to EK3, dependingupon the
vectorand DNA used. The firstrevision(published in 1978) exempted
experimentswith DNA in E.coli K12 that came from organismsthat
naturallyexchangedDNA withE.coli in nature.By the thirdrevision(in
1980), most experimentsusing E.coli K12 had been exemptedfromthe
guidelines.20The guidelineswere a barometerof the changingrelationship
between hazards and theirminimization- sets of causal relationsfrom
whichthe riskof usingE. coliK12 as a host forforeignDNA emerged.As
particularassociationsheld, the referent'real risk' of using E. coli K12 in
gene technologyresearchtook shape and became a circulatingreferent of
riskin the Hoechst dispute.
Just as in the rDNA debate, risks in the Hoechst dispute were
materiallyconfiguredas relations between differenthazards and their
minimizationin containment.As we shall see, the Hoechst dispute was
about negotiating'trials of strength'betweenmultiplerisks,2'each con-
tingentupon a different set of causal relationsbetweenhazards of E. coli
K12 bacteria, geneticallymodified with a meerkat insulin gene, and
practicesof physicaland biologicalcontainment.
In adoptingthisapproach,it is not myintentionto denythatobjects
such as E.coli K12 bacteriaor DNA existexternalto our investigations of
them.Rather,I wantto questionthe realistnotionthatobjectsexistor are
constitutedas real outside of, or apart from,the interactiveconditionsof
their emergence. If we are to understandrisk not as abstract but as
materiallycontingentgeneralizing,thenwe need to examinethe material
practices that configurehumans and non-humans into sets of causal
relationsfromwhichrisksemerge.Moreover,we need to understandthe
importanceof the referent'real risk' in linkingsome risksand separating
others. It is with such links that multiplerisks become generalizedas
singular,in thiscase as the riskof the human insulinfacility.
The Initial Risk Assessment
When Hoechst proposed theirhuman insulin facility,the German gene

technologyguidelineswerein theirfourthrevision.Publishedin 1981, this
version of the guidelines outlined categoriesof physicaland biological
containmentforgene technologyresearchthatmaintaineda 10-litrelimit
on thequantityofbacterialculturethatcould be used. Workusingvolumes
ofculturegreaterthan 10 litresrequiredspecial considerationand approval
on a case-by-casebasis. Hoechst's initialapplicationwas forthe firststage
of the human insulinfacility,
'Fermtec'. Fermtecwas designedto operate
witha volume of 60,000 litresand was the firstfacilityof thisscale to be
considered by the German equivalent of the US Recombinant DNA
AdvisoryCommittee,the Central CommitteeforBiological Safety.22 The

CentralCommittee'stask was to assess the risksof Fermtec,and recom-

mend levelsof physicaland biologicalcontainment.
The Committee was established along with the firstguidelines in
1978; however,itwas not untila decade later,in 1988, thattheCommittee
issued its firstReport.23This Report brieflysummarizesthe workof the
Committeeforthe period 29 September1981 to 30 June 1988. During
this approximately seven-yearperiod, the Central Committeemet on 26
occasions and considered1332 applications- an averageof 51 per meet-
ing. This suggestsa hurriedand potentiallysuperficialstyleof decision-
making,an observationalso made by HerbertGottweisin his account of
theworkofthisCommittee,whichis based partlyon an interviewwithone
of its members.24In the period of the Report, the Central Committee
considered 100 applicationsforworkover the 10-litrelimit,of which 30
were forproduction-scalefacilities.The Report does not identifyor give
any details about individualapplications;however,we can assume that
Hoechst's facilitywas the firstof these,because Hoechst's applicationfor
Fermtec,in 1984, was the firstin Germanyfora commercial-scalefacility
thatused gene technologyas the methodof manufacture.As the Report
shows,thenumberofproduction-scale facilities
proposedincreasedrapidly,
with30 applicationsin the space of fouryears.To accommodatethis,in
1986, the guidelineswere amended expresslyto regulatework over 10
litres.Withregardto theCommittee'sexaminationofHoechst'sapplication,
it would be reasonableto assume that a major focus of the deliberations
was on the adequacy of Fermtec'sphysicaland biological containment.
This would be in keepingwith the articulationof risk firstestablished
duringtherDNA debate and writtenintothe Germanguidelines,whereby
the risk of any project is contingentupon the degree of containment
offeredbythehost-vector systemused, and thephysicalspace in whichthe
workis carriedout. This referent 'real risk'guided the approachtakenby
the Committeeto the potentialhazardsposed by E.coli K12 containinga
meerkatinsulingene.
WhenHoechst'sFermtecapplicationwas initially considered(in 1984),
the Central Committeerecommendeda physicalcontainmentclassifica-
tionofL2 (the equivalentof P2 in theUS guidelines),whichrequiredthat
the physicaldesign of Fermteccompletelypreventany release of genetic-
ally modified organisms into the environment.They also allocated a
biologicalcontainmentclassification ofB1 to thehost-vector system,E.coli
W31 10 (pWHl), used in Fermtec (equivalent to EK1). This was the
lowest level of biological containment.It would have been routinely
applied to host-vectorsystemssuch as the one used by Hoechst, based on
the consensus achieved duringthe rDNA debate that E. coli Kl 2 was a
poor survivoroutsidelaboratoryconditions,and thatplasmidsof the type
used by Hoechst did not readilytransferDNA to othermicroorganisms.
Accordingto the German guidelinesin place at the time of the Fermtec
application,a B 1 level of biological containmentwas appropriatefor all
KI 2 host-vector systemsiftheinsertedgene was not pathogenicor toxicto
humansor animals.25

In 1986, when the 1981 version of the guidelineswas revised,the

insulinfacilitywas re-labelledunderthisnew systemas an LP2 B 1 facility,
wherethe'P' indicatedthatthefacilitywas ofproductionscale.26Over the
seven-year period ofthe CentralCommittee'sReport,95% ofall proposals
used E. coliKI 2 as thehost organism,and amongthesethemostfrequently
used vector was plasmid pBR322, the same plasmid that Hoechst had
modifiedto produce the plasmid pWHl used in Fermtec.27In relationto
the guidelines,therefore, the biological componentsof the Fermtecwere
standard,whereasthe physicalconditionsimposed by a 60,000-litrefer-
menterwerenovel.
Hoechst needed to designFermtecto complywiththeLP2B 1 contain-
ment recommendedby the Committee.This meant that all the com-
ponentsof Fermtec,such as thebuilding,fermentation tanks,waterpipes,
filtersand the like, should preventthe release of the geneticallymodified
E. coliKI 2 bacteriaintotheenvironment. thestrainofE. coliK1 2
Similarly,
used by Hoechst, and the plasmid used to transportthe insulingene into
thathost,weredesignedto be biologicallyenfeebledso as to minimizethe
possibilitythat the insulin gene would be transferredto other micro-
organisms.The hazards of using gene technologyto manufacturehuman
insulinwere thereforemateriallyconfiguredby the practicesof physical
and biologicalcontainmentincorporatedintoFermtec'sdesignand opera-
tion.The risksof the human insulinfacilityemergedfromthisconfigured
materialitywithinsets of causal relationsbetweenE.coli K12, plasmids,
filters,waste-watertreatment, maintenance,routineoperationsand other
humanand non-humanpracticesintegralto thearchitecture and operation
of the facility.
However, the containmentadvice fromthe Central Committeefor
Biological Safetywas onlythefirststep.Next, Hoechst needed approvalto
proceed withthe buildingof Fermtecfroma local governmentauthority
called the 'Regierungspriisident';thisapprovalwas granted,in June1985,
in accordance with a Federal pollution control law called the Bundes-
immissionsschutzgesetz (BImSchG).28In consideringHoechst'shumaninsu-
linfacility,thelocal authorityacceptedtheadviceoftheCentralCommittee
thatthe riskwas minimalif the levels of physicaland biological contain-
ment theyrecommendedwere in place. However, this approval was to
prove contentious.Several residentsof the suburb of Hdchst,29in which
the Hoechst factorywas located, were opposed to the facilityand, in
particular,to its use of gene technology. These individualswere members
of a small citizensgroup called the Hoechster Schnuiffler un Maagucker
This grouphad been monitoring
('the Schnilffler').30 theHoechst company
forseveralyears,in particularforactivitiesthatwerelikelyto resultin air or
water pollution.Their motto,inscribedon a shield-likelogo, framinga
dark factorywith smoke stacks billowing,was 'for clean air and clean
water'. The insulin factorydid not billow pollutingsmoke but, for the
Schnuffler, had the capacity for pollution that was more insidious: the
release into the environment of microscopicbacteria,geneticallymodified
withan insulingene.

For the Schniiffler, the risk was linked to the scale of the insulin
facility,whichtheyarguedallowed forthe veryreal possibilitythatpart or
all of the 60,000 litresof geneticallymodifiedE.coli K12 could be released
into the environment.They questioned the validityof the approval of
Fermtec,a commercial-scalefacility,grantedon the basis of guidelines
writtenprimarily to regulatesmall-scalelaboratorywork,and theyargued
thatBImSchG was inadequate because it containedno referenceto gene
technology.The Schnuffleralso expressedtheiroppositionto Hoechst's
facilityin broad terms.For example,in one oftheirnewsletters entitledNo
Genetically ManipulatedBacteriain Hochst,theylisteda rangeof objections
They positedthatgene technologypresentedan incalculable
to the facility.
risk; that Hoechst did not consult the public; that diabetes treatment
would not be improvedby human insulin;thatthe productionof human
insulinwas, therefore, unnecessary;and thatHoechst was headingin the
wrongdirectionin developingsuch a product.3"In an effortto have the
approval reconsidered,theyapplied for a hearingunder legislationthat
allowscitizensto objectto a decisionmade bytheState,providingtheycan
show that theyare in some way adverselyaffectedby that decision.32If
evidenceof potentialhazard can be shown,the local authority responsible
forthe approvalof the facilitymust allow the citizensto presentfurther
evidence of that hazard, in light of which the approval may be re-
considered.
The law sets restrictions to participatein
on an individual'seligibility
thisprocess.For instance,objectionsto an approvalmustbe lodged within
two years subsequent to that approval. Individualsraisingan objection
mustresidewithina 50kmradiusofthefacility, and are requiredto present
a preliminarycase, to the satisfactionof the local authority,that their
concernsabout safetyare sufficient to warranta hearing[DR, 127-28]. In
fact,the Schniiffler did not satisfythefirstoftheserequirements, and were
grantedspecial permissionto lodge theirobjectionsbeyond the two-year
limit.The local authorityaccepted the Schnuiffler's primafacieobjections,
and admittedthem as participantsin a review of Fermtec's approval.
Within this review process, the Schnuiffler were no longer peripheral
activistsbut counter-experts recognizedprocessof decision-
in an officially
making.This meant that the formand contentof theirobjectionswere
prescribedbythatprocess,and bytheguidelinesand legal statutesthathad
been used to approvethe facility.Objections could onlybe made against
the criteriaupon whichthe approvalhad been given.In orderto stop the
facility,the Schniufflerhad to convincethe local authoritythattherewere
inadequacies in Fermtec'sphysicaland biological containment,and this
requiredthem to engage in scientificargumentsabout hazards that had
been misconstruedand misunderstoodin the initialdecision to approve
Fermtec.33
As we shall see, thisdrewthe Schnuffler into a complexscientificand
technicaldebate about the hazards of manufacturing human insulinusing
geneticallymodifiedE.coli K12 bacteria.They were requiredto present
scientificand technical evidence for relationshipsthey believed existed

Robins:The RealnessofRisk:GeneTechnology
in Germany 19
between the hazards of the modifiedbacteria and the physicaland bio-

logical containmentof the facility.In the initialapprovalof Fermtec,the
Central CommitteeforBiological Safetyhad advised the local authority
thatifan LP2B 1 level of containmentwerein place, thehazardswould be
sufficientlycontainedand the riskwould be a minimalvariantof a well-
understoodrisk,whichemergedwithinthe rDNA debate. In otherwords,
forthe CentralCommittee,LP2B1 representeda set of materialrelations
withinthe human insulinfacilitythatkeptthe hazard to a minimum.For
the Schniuffier, however,materialrelationswithinand outside the facility
configureddifferent soughtto establishan alternative
risks.The Schniiffler
referent 'real risk'.
Re-assessing the Risk

The Schnuffler's objectionsto Fermtecwerepresentedin a writtenreport
to the local authority,in an effort to convincethisauthoritythattheriskof
Fermtec had been misunderstood,and that the approval of Fermtec
should be revoked.Hoechst was giventhe opportunityto respondto the
Schniiffler's objections.The Schnuiffler, Hoechst, the Central Committee
forBiological Safetyand the local authorityall weighedinto this debate,
each articulating riskas a set of causal relationsbetweenthehazardsposed
by the production of human insulin using gene technology,and the
containmentaffordedby the facility.For example,in theirsubmissionto
the reviewprocess,Hoechst commentedon the biologicalcontainmentof
E. coli K12 as follows:
Aftermore than 15 yearsof the applicationof gene technology,the risks

can be judged much more accurately.This has also led to new insights.
The probabilitythatgene technologycould accidentallycreatea pathogen
froma harmlessmicroorganism is, on thebasis of currentassessments,so
small thatthereis no real risk. [Hoechst,3] 34
In contrastto Hoechst's insistence that there was 'no real risk', the
assertedthatthepossibilityofhazard could not be ruled out. In
Schniiffler
theirsubmissionto the reviewprocess,theycommentedthat:
Afterescaping from the facility,E.coli W3 110 (pWH1) bacteria are

capable ofsurvivingin the environment,in humansand in animals.There
is the dangerthatE.colicould interactwithotherorganismsand thatthis
mighthave a negativeimpacton humanhealth.The possibilitycannotbe
ruled out that the productionstraincan express its fusion-protein,
the
- Pre-proinsulin,
J3-Galactosidase outsideoftheproductionprocess.Negat-
iveeffectsofthefusion-proteinin thehumanbodyareto be anticipated.35
In the reviewof the approval,each componentof the relationshipbetween

hazard and its minimizationcomes under scrutiny. Air filters,waste-water
treatment, the survivalof E.coli K12 in soil, in water,or in the human or
animal intestine,the featuresof plasmids that enable them to move
betweenbacteriaand to transfer DNA fromone bacteriumto the another,
and human activitiessuch as maintenanceand monitoring,are all related

to how adequatelytheyperformcontainment. As mentionedearlier,details

of the CentralCommittee'sdeliberationson the riskof Fermtecwerenot
revealedwhen theyfirstmade theirrecommendationthatthisstage of the
facilityshould operatewithan LP2B1 level of containment.However,the
referent'real risk' that emerged within the rDNA debate prioritized
containmentas the main determinantof risk.Most of the riskassessment
experimentsperformedduringand followingthe rDNA debate aimed to
assess and improvethe containmentofferedby host-vectorsystems,rather
than elaborate on the details of the hazards posed by gene technology
research.36This referentguided the Central Committee in settingan
LP2B 1 level of containmentfor Fermtec.Accordingto this referent,if
containmentresultedin no releaseofgeneticmaterialintotheenvironment
the facilityposed only a minimal variant of a well-characterizedrisk.
Hoechst's risk of Fermtec (re)performedthis referent.The company
arguedthatan LP2B 1 level of containmentwas in place, and therewould
be no releaseofgenetically modifiedbacteriaor DNA fromthefacility. The
Schnuffler'srisk,on the otherhand, performeda different referent'real
risk'.This group argued that Fermtec's containmenthad been miscon-
strued,and the likelyimpact of a release of modifiedbacteria fromthe
facilityneeded to be reconsidered.In the followingsectionsof thispaper I
examine how the Schnufflerand Hoechst characterizeddifferent sets of
materialrelations,different performancesof physicaland biological con-
tainment,and different risks.
Physical Containment
The bacteria used in Fermtec were physicallycontained inside large
stainless-steelfermentationtankshoused withintwo buildings.However,
the process of manufacturing human insulingeneratedwaste thatneeded
to be removed.This meantthatneitherthe tanks,nor the buildings,were
completelysealed containers.Waste air and wastewaterhad to be emitted
into the environmentoutside the facility,and there were openings that
allowed forthis.To preventthe release of modifiedbacteriathroughthese
passages,thewasteairwas filteredand thewastewaterheat-treated, before
being emittedfromthe facility.These passages were,nevertheless, sitesat
which there was the potentialfor breaches in the LP2B1 'no release'
requirementof containment, ifthefilteringof air or thetreatmentofwaste
waterfailedto eliminateall geneticallymodifiedbacteriaor DNA. As the
most likelyavenues for the release of geneticallymodifiedbacteria or
DNA, thesesitesofpotentialweaknessin therelationship betweenhazards
and theirminimizationbecame points at which, for the Schnufflerand
Hoechst, differentmaterialrelationsperformeddifferent risks.
The air filters,in performingLP2 risk,had to ensurethattherewas
no release of geneticallymodifiedorganismsor DNA. The materialcom-
ponents of the filtersneeded to be configuredin such a way that all
geneticallymodifiedbacteria and DNA would remaininside the facility,
blocked fromescaping by the filters.The risk,therefore, was contingent

upon a set of causal relationsbetweengeneticallymodifiedbacteria,DNA,

filtercomponents,air inside and outside the facility,and various human
interactionswith the filters.However, for the Schniiffler, risk emerged
withina set of causal relationsthat differedfromthose inscribedby the
LP2 levelofphysicalcontainment recommendedbytheCentralCommittee
forBiological Safety.The filtersused in theinsulinfacility weremade from
teflonwith a pore size of 0.2 m. The Schnufflerdid not question the
adequacy of the 0.2 m but arguedthat,forvariousreasons,thispore size
might vary, or could be damaged during routine maintenance.They
suggested,forinstance,thatsmallmetallicparticlesin the air of the plant,
given offby the movingmechanicalparts, could enlargethe size of the
pores in the filters.They claimed that filterswith a slightlylargerpore
diameterof 0.3 m were only 99.997% effective duringthe normalexpul-
sion of particles,and that30 out of every1 millionparticleswere able to
pass throughthem.Pores thatwere largerstillwould let throughan even
greaternumberof particles [M&N, 19].37 The Schniiffler also suggested
that an explosion withinthe fermenterwould be part of the material
relationsof risk.If the fermenter were to operateunder anaerobic condi-
tionslong enoughto allow hydrogengas to accumulatein it and ifthe gas
wereto igniteand explode,thepressurefromtheexplosionwould be above
that which the filterswere designed to withstand,and geneticmaterial
would thenescape unhinderedinto the environment[M&N, 20]. For the
Schnuiffler, the air filterswere components of the facility,materially
configuredin relationto other human and non-humancomponentsto
produce a set of causal relations(hazards and theirminimization)which
performeda specificrisk.
In response to the Schnuffler'sclaims, Hoechst emphasizedthe un-
likelihoodof such eventsoccurring,and cited theirexperienceoperating
similarfacilitieswithoutincident.They referredto teststheyhad under-
taken on the filters,which they claimed demonstratedthat the filters
functionedto the desiredstandards.The filtersused in the insulinfacility
were, accordingto Hoechst, state-of-the-art, and were guaranteedby the
manufacturer to filterout all geneticmaterialcompletely:bacteria,plasmids
and DNA. Hoechst assertedthatthe effectiveness of the filterswould be
testedfollowingtheirinstallationto detectanydamage thatmayhave been
caused by the installationprocess,and thiswould be followedby regular
checksand maintenancethroughoutthe operationofthefacility[Hoechst,
20]. Hoechst's 'risk',likethe Schnuffler's, was contingently linkedto a set
ofcausal relations(hazardsand theirminimization).However,thematerial-
ityof Hoechst's riskdifferedfromthe Schnuffler's. It did not include,for
instance,damage or explosions as causal entitiesin the performanceof
risk.
AnotherrequirementoftheLP2 levelofphysicalcontainmentwas that
all E. coliK12 bacteriain the waste wateremittedfromFermtecwould be
killedby heat sterilization. Here, too, forboth the Schnuffler and Hoechst,
there were different risks.The Schnuffler'srisk, for instance,was con-
tingentupon difficulties in controllingthetemperature and durationofthe

sterilization ofwastewater.They suggestedthatcertainfactors,such as the

turbulenceof waste water,could forcethe waterthroughthe pipes faster
than the time needed to sterilizeit. If inadequatelysterilizedwaste water
was to be releasedfromFermtec,thedangeritposed could be compounded
if it were to pool with waste water from neighbouringfacilitiesthat
contained bacterialnutrients.Such nutrientscould enable the modified
bacteria to survivelong enough to colonize the waste-watercanals, and
pose a threatto the environment[M&N, 21].
Hoechst respondedthattheflowofwastewater,ifturbulent, would be
in a whirlpoolformation, and thiswould slow the speed ofthewaterin the
pipes ratherthan speed it up. Hoechst cited evidence fromtests of the
waste-watertreatmentused in Fermtec. In these tests, the water was
heated to 120?C forfiveminutes,and thisnot onlykilledthebacteria,but
inactivatedthe plasmids.They cited instancesin whichvolumes of water
well in excess of thatused in Fermtecwerefullysterilizedat temperatures
and timesclose to those used in Fermtec.Accordingto Hoechst, the heat
sterilizationmethodsdeployedin the facilityensuredwhat theycalled 'a
multipleinactivationoverkill'of all recombinantbacteria [Hoechst,28].
For Hoechst, the relationshipsbetweenhazard and containmentthat
wereimplicatedin riskwerethoseperformedduringthe routineoperation
of Fermtec- whereas,forthe Schnuffler, the causal relationsof riskwent
beyondthe routineoperationof the facility, and incorporatedinstancesof
faultyoperationand accidents.For both the Schnuffler and Hoechst, the
air filtersand waste-water treatmentperformedrisksofFermtec.However,
Hoechst's risk differedfromthe Schniiffler's risk,because each was an
outcome of a differently configuredmateriality:a differentset of relations
betweenhazards and theirminimization.
This point can be illustratedfurtherif we examine the risks,forthe
Schnuffler and Hoechst, of the cooling system.The cooling systemcom-
priseda successionof coolingrods,whichregulatedheat generatedby the
fermentationand sterilizationprocesses. The Schnufflersuggestedthat
the welds joining the componentsof the cooling systemmightnot be
completelysealed. They depicted an accident scenariowherebya pump,
carryingthecoolingmixture,overflows, causingthepressurein the cooling
systemto drop below that in the fermenter.Because of this drop in
pressure,the contentsof the fermenter overflowinto the cooling system
and overthe poorly-sealedwelds, allowingforthe release of bacteriaand
DNA throughthe gaps in thewelds and intothe environment [M&N, 21].
However, according to Hoechst, the pressure differencebetween the
fermenter and the coolingsystemwas strictly controlled.If a differencein
pressureof more than 0.5 bar occurred,an alarm would sound. If the
pressurein thefermenter wereto rise,regulationvalveslocated behindthe
heat-exchange mechanism would close. If the pressure in the cooling
system were to drop, an additionalpump would be activatedto increase
the pressure[Hoechst,29].
Justas withthe air filtersand waste-watertreatmentexaminedabove,
the Schniiffler's and Hoechst's risksof the coolingsystemwere contingent

upon different sets ofmaterialrelations.The Schniiffler focusedon poorly-

sealed welds, whereas Hoechst emphasizedthe proceduresin place that
would preventthe contentsof the fermenter fromoverflowing on to those
welds. For both the Schniiffler and Hoechst, the materialrelationsthat
performedthe risks of the human insulin facilitywere located in its
architectureand in its operation.Askingwhereriskwas located helps us
see it as architectureand as practicesperformedby air filters,waste-water
treatment,welds in the cooling system,alarms, pressure differentials,
human worksuch as maintenance,geneticallymodifiedbacteria,plasmids
and DNA. There were multipleways to 'do' the relationshipbetween
hazardsand theirminimization, multiplewaysto 'do risk'.This multiplicity
was also evidentin the different sets of causal relationsproposed by the
Schniiffler and Hoechst forbiologicalcontainment.
Biological Containment
Physicalcontainmentwas designedto preventthe bacteriaescapingfrom
the facilitybut, if it failed,biological containmentacted as a back-up,to
maintainthe hazard/containment relationship.Accordingto the Central
CommitteeforBiological Safety,the host-vectorsystemused in Fermtec
satisfiedthe criteriaforB1 biological containmentrecommendedin the
guidelines.As such, it was a host-vectorsystemexpected to be a poor
survivorin the environmentoutside the facility,and unable to transfer
genetic materialto other microorganisms. The Schniiffler argued, how-
ever,thatthe biological containmentof Hoechst's host-vectorsystemwas
inadequate because the E. coliK12 could survive,and persistlong enough
in the outsideenvironment to enable the possibilityof gene transfer.
Here
the evidencecited came fromscientificpapers,whichreportedthe results
of experimentsdesignedto test the containmentpotentialof a varietyof
differentstrainsof E. coliK12, and typesof plasmids,fortheiruse in gene
technology.For instance,the Schniiffler claimed therewas evidencethat
certainstrainsofE. coliK1 2 had been detectedin unsterilizedsoil forup to
three weeks.38They also argued that E.coli K12 had been detected in
unsterilizedriverwater for up to 260 days, and thereafterexisted in a
dormantstateof 'starvationsurvival'wheretheybecame undetectable,but
were stillalive and able to be revivedwhen bacterialnutrientswere added
to the water.39Accordingto the Schnuffler, this showed that even when
E.coli K12 cannot be detectedin soil or water,theymay neverthelessbe
presentin a dormantstateof 'starvationsurvival'.Severalscientific papers
were cited by the Schnuffleras evidence fortheirclaim that E. coli K12
bacteria could be difficult to detectwhen under conditionsof stress,but
could reach detectablelevels if nutrientconditionsbecame more favour-
able.40The Schniiffler attemptedto link these instancesof E. coli K12's
behaviourto the E. coliK12 strainused by Hoechst, to suggestthatit had
the potentialto surviveoutsidethe facility, particularlyifreleasedin waste
waterthatthenpooled withwatercontainingbacterialnutrientsthathad
been emittedfromneighbouringfacilities[M&N, 11-13].

However, for Hoechst, the materialityof F.coli K12 in the various

environments and conditionsdescribedin the scientificliteraturediffered
fromthe materialityof theirstrainof F.coli K12 in the human insulin
facility.They argued that it was only possible to get an accurate and
relevantassessmentof the survivalcapacityof the Fermtecstrainof F.coli
K12 bacteriain soil or waterwhen the naturalconditionsof the environ-
ment outside the human insulinfacilitywere simulatedin the laboratory.
Hoechst linkedthe risk of F.coli K12's survivaloutside the facilitywith
data generatedin experimentstheyhad conductedwithwhat theycalled
the 'authentic'F.coli strainand plasmid used in Fermtec,and a 'natural'
soil sample obtainedfromoutsidethe facility. Accordingto Hoechst, their
experimentsprovidedevidencefora dramaticreductionin the numberof
bacteriaafterfiveto sevendays,and thisdid not changewiththe addition
of a nutrientmedium.The realnesswith which these experimentswere
able to performriskwas contingentupon the associationsHoechst was
able to build betweenthe experimentalconditionsand the naturalecology
of the area surroundingthe human insulinfacility, such as the canals into
whichthe wastewaterflowed[Hoechst, 10-1 1].
The realityof the survivalof E. coliK12 bacteriain soil and waterwas
in part a prerequisiteforthe potentialof E. coliK12 to infectthe intestinal
tractof animalsand humans.Evidenceofthe survivalratesofE. coliK1 2 in
the intestinaltractof animals and humans had been a major focus of the
rDNA debate, and importantin settinga level of biological containment
forthe use of F.coli K12 bacteriain gene technology.At the time of the
Hoechst dispute,there existed a significant body of scientificliterature,
mostofwhichhad been generatedduringtherDNA debate,on whetheror
not E. coli K12 could become an epidemicpathogen.The consensusthat
emergedwas thatE. coliK1 2 could not survivewellin thehumanor animal
intestine,and thereforedid not have the capacityto become an epidemic
pathogen.It was this consensus that justifiedassigningan EKi level of
biologicalcontainmentto E.coli K12 in the earlyguidelinesregulatinggene
technology.4'It was thisreferent'real risk' of F.coli K12 thatthe Central
CommitteeforBiological Safetyapplied to Fermtecin assigningit a B1
level of containment,and this referentof risk that the architectureof
Fermtec,accordingto Hoechst,had been designedto uphold. However,as
historiansofthisperiodhave noted,therewas also evidenceofE.coli Ki 2's
abilityto surviveforlimitedperiods of timewithinthe human or animal
intestine.42 The Schnuiffler linked Hoechst's F.coli K12 strain to this
evidence in an attemptto build a differentset of relationsabout the
survivalcapacityof the Hoechst strain.For instance,the Schnuffler cited
twopapers publishedduringthe rDNA debate as evidenceforthe survival
in thehuman intestineofE. coliK12 thathad, likethe Hoechst bacterium,
been specificallyenfeebled.43 With referenceto these papers, theynoted
that even E.coli K12 bacteria that had been modifiedto be extremely
fragile,such as the 'high safetystrain' X1776, were able to survivefor
severaldays in the human intestine.They also attemptedto link F.coli's
abilityto survivein a state of starvationsurvivalin riverwater, to a

Robins:The Realness of Risk: Gene Technologyin Germany 25
potential for similarbehaviour in the human intestine.The Schnuffler

suggested,for example, that a reductionin the selectionpressurefrom
otherbacteriain the intestine,due to antibiotics,could provideconditions
favourableenoughto revitalizeweakenedrecombinantE. coliKI 2 bacteria
carryingantibioticresistancemarkers[M&N, 13].
Hoechst, on the otherhand, cited different experimentsconducted
during the rDNA debate, and built different links between what these
experimentsshowed about the survivaland passage of E.coli K12 in the
human intestineand the strainof E.coli K12 used in Fermtec." In these
experiments,several non-recombinantstrainsof E.coli were monitored,
such as the E.coli K12 strainX1776 and its plasmid bearing derivative
X2236, and the E.coli K12 strainX1666 and its plasmid-bearingderivative
D20-5. The plasmid-bearingstrainseach containedplasmidpBR322, the
same plasmid modifiedby Hoechst for use in Fermtec. According to
Hoechst, the results fromthese experimentsindicated that E.coli K12
could only survivefor a limited durationin the human intestineand,
duringthat time,K12 was unable to colonize the intestineor cause any
harm:
NeitherE.colistrainwas able to colonise the intestinaltractof the volun-

teers, and neitherwas detectablemore than 6 days afteringestion....
These results,whichprovidedata on survivalof an EK1 and EK2 system
in mammals, support their safe use in recombinantDNA technology
underroutinelaboratoryconditions.[Hoechst, 11]
It was on the basis of this and otherevidence that Hoechst linkedtheir

host-vectorsystemto otherB1 systems,to conclude:
data thatE.coliK1 2-cellsare unable

... on thebasis ofthefullestscientific
to colonise the human or animal intestine.Their survivalin the environ-
ment is of limitedduration(max. 3 weeks) and has no negativeeffects.
[Hoechst, 13]
Anotherriskrelated to biological containmentwas the potentialfor

anybacteriathatwerereleasedfromFermtecto transfer theinsulingene to
other microorganismsin the environment,or in the intestinaltract of
humansor animals.This depended upon the mobilityofthevector,in this
case the plasmid, which carried the gene. Here, too, links were made
betweenFermtecand evidence generatedduringthe rDNA debate. The
Schnuffler,for instance, cited the results of experimentsundertaken
duringthe rDNA debate to test the mobilityof plasmids used in gene
technology.45 According to the Schnuffler,the evidence showed that
plasmid transferwas a poorly understood and complex process that
depended upon manyvariables.One outcomeoftherDNA debatewas the
productionof plasmids speciallydesignedto satisfyspecificrequirements
of biological containment,and the most common modificationwas to
delete the plasmid's transfer
functions.The plasmid used by Hoechst was
of this type: a so-called 'safetyplasmid'. The Schnufflerargued that
althoughtheseplasmidshad been modifiedto prohibitDNA transfer, such

a transfercould stilltake place because the DNA could be mobilizedby

another microorganismwith its transferfunctionsintact. In such an
incident,the recipientplasmid would become the active agent in the
transferof DNA [M&N, 14-15].
Hoechst agreed that naturallyoccurringplasmids could, under the
rightconditions,transfer to othermicroorganisms. However,theyinsisted
that their plasmid had been geneticallymodified to preventtransfer.
Hoechst alwaysreferred to theirplasmidas a 'safetyplasmid' thatsatisfied
the containmentrequirementsset out in the guidelines.They cited several
papers publishedduringthe period of the rDNA debate,whichdiscussed
the role of 'safetyplasmids' in the maintenanceof EKI and EK2 host-
vectorsystems.46 Hoechst arguedthatthe Schniiffler's evidencewas irrele-
vant to Fermtec,because the data were derivedfromexperimentswith
plasmidsthatwere not 'safetyplasmids' in the strongsense thatcould be
applied to the plasmidused in Fermtec[Hoechst, 14].
Bi (EKI) was a level of biological containmentforE.coli K12 that
emergedwithinnegotiationsabout the safetyof E.coli K12 as a host for
foreignDNA duringtherDNA debate. It was a referent of riskcontingent
upon associationsmade at thattime: on materialrelationsmade between
E.coli K12, soil, water, humans, animals, plasmid vectors, and other
microorganisms. When the CentralCommitteeforBiological Safetycon-
sideredHoechst's host-vectorsystem,theydid not need to re-buildthese
relations.In allocating B1 to Fermtec, the referent'real risk' of gene
technologyinscribedin theguidelineswas generatively (re)performed, and
the associationsbetweenhazard and its minimizationthat had emerged
fromthe rDNA debate held.
Hoechst made linksbetweentherisksofthehumaninsulinfacilityand
the referent'real risk' inscribedin the guidelines.The Schnuffler, on the
otherhand, attemptedto unmaketheselinksand build new ones. For the
Schnuffler, linksbetweenFermtecand B 1 did not hold, and a new referent
was needed. Hoechst,on the otherhand, made stronglinksbetweenB 1 as
the referent'real risk' and the materialrelationsperformedby Fermtec.
The disputeinvolvednegotiating'trialsof strength'betweendifferent risks
and different 'real risk'referents.
The Hazard
I have thus farexaminedthe materiality of riskas performedby physical
and biologicalcontainment.However,whatmightbe said about hazards?
In accordancewiththe logic of the referent'real risk'thatemergedwithin
the rDNA debate,hazardswerelikelyto occur at the pointwherecontain-
ment failed: forinstance,if the bacteria were released fromthe facility,
survivedand transferred geneticmaterialto otherorganisms.The hazard at
thispointwould be the impactofthepre-proinsulin, producedin theE. coli
K12 bacteria,if activein environments wherethe bacteriasurvived,such
as thehuman intestineor in the environment. The meerkatgene produced
a proteinprecursorto human insulin,and thishad attachedto it another

proteincalled /3-Galactosidase, which was a by-productof the E. coli KI 2

bacteria.The Schnufflerwere particularlyconcerned with the potential
harm caused by thisfusion-protein insidethe cells of thehuman intestine.
They made linksbetweenthe pre-proinsulinand insulin-likegrowthfac-
torsI and II, and the hormoneRelaxin,because all belonged to the same
proteinfamily.They argued that these proteinswere structurally similar,
had the potential to bind to insulin receptorsin the cells, and could
produce some insulin-likeactivity.Harm, they suggested,was likelyto
occur if this insulin-likeactivityalteredthe body's metabolismadversely.
The Schniiffler pointed out thattherewas an absence of data about the
effectsin humans of the pre-proinsulinproduced in Fermtec, and this
meant thatthe risksof the pre-proinsulin were uncertainand unpredict-
able [M&N, 17].
Hoechst admittedthat the hormones mentionedby the Schnuffler
could bind to the same receptorsas insulin,but linkedthisto a completely
different reactionin the cell. Accordingto Hoechst, the hormoneswere
structurally differentto human insulin,and the pre-proinsulin produced
inside E.coli K12 bacteriadid not have the tertiarystructurenecessaryto
produce the human insulinprotein.They argued thatinsulin-likegrowth
factorsI and II, and Relaxin, are only distantlyrelatedto insulinin that
they are part of the same gene family.Hoechst insistedthat therewas
no functionalrelationbetween the hormones and insulin,and that the
Schnufflerwere mistaken in drawing links between them [Hoechst,
17-18].
The Schnuffleralso linked the fusion-proteinpre-proinsulinto a
potentialfortumourformationand cancer,ifthe proteinwas expressedin
the human body overa long period of time.They referredto a paper that
discussed a case in which a human oncogene product, found in an
intestinalcancer, had been caused by a fusionbetween two genes. The
Schnufflersuggestedthat the fusion-protein precursorto human insulin
mightalso disruptoncogenes in human cells and lead to cancer [M&N,
18]. Hoechst respondedthattherecould be no linkof thiskind between
the fusion-protein, oncogenes and cancer. In theirview,this was a good
example of the ridiculousand extremenatureof the Schniiffler's claims.
Certainlythepre-proinsulin was a fusion,but itwas withthename thatany
comparison ended, and only by some leap of the imaginationthat the
fusion-protein produced in Fermteccould be linkedto cancer [Hoechst,
17-18]. Wherethe Schniiffler attemptedto build links,Hoechst insistedno
linkscould be found.
The Report of the Local Authority

The local authority(throughthe officeof Der Regierungpriisident), in
reviewingtheirdecisionto approveFermtecin relationto the Schnufffler's
objectionsand Hoechst's responseto thoseobjections,again consultedthe
Central CommitteeforBiological Safety.The Committee'sresponsewas
unequivocal: 'The risk of harm resultingfromhandlinglive E.coli K12

bacteriaW3 110 (pWHl) is, according to currentscientificknowledge,

extremely small' [DR, 124]. The Committeeupheld the associationsmade
between the hazards of E.coli K12 and the biological containmentin-
scribedin the guidelines,and in doing so (re)performed the referent'real
risk'thatemergedwithinthe rDNA debate. In the Committee'sview,the
links that the Schnufflerattemptedto make between the scientificevi-
dence and the hazards or inadequacies of Fermtec'scontainmentdid not
hold [DR, 125]. In relationto biological containment,for instance,the
Schnuffler'srisk was contingentupon material conditions that would
enable Hoechst's host-vectorsystemto be released fromFermtec and
survivein soil, in water,or in the animal or human intestine,long enough
to transferthe plasmid containingthe insulingene to othermicroorgan-
isms in those environmentsand cause harm [DR, 116]. The Central
Committee'sresponse was that: 'There is no evidence to supportthese
claimsand it does not reflectthe currentviewof the scientificcommunity'
[DR, 117]. For the CentralCommittee,the 'currentview of the scientific
community'held, as did the material relationsbuilt into Fermtec by
Hoechst,in whichtherelationship betweenhazardsand biologicalcontain-
ment performeda minimalversionof a well-characterized risk of gene
technology. This was also the case in relationto physicalcontainment. The
LP2 classification requiredthattherebe no releaseof geneticmaterialinto
the environment. The Central Committeewere satisfiedthat Hoechst's
facilityupheld the materialconditionsrequiredby LP2: Fermtec,in their
view, performedcontainmentto a standardwell above that which was
really necessaryfor a productionfacilityof this kind [DR, 124]. The
Schniiffler'sriskscould not be linkedto the ways of doing 'real risk' of
using E.coli K12 in gene technologythathad emergedwithinthe rDNA
debate, and were inscribedin the guidelines.Instead, the linksmade by
Hoechst, between this referent'real risk' and the potentialhazards of
Fermtecand itsphysicaland biologicalcontainment, werethosethatheld.
In consideringthe relationshipbetweenthe potentialhazard posed by
Fermtecand its physicaland biological containment,the local authority
was guided in their response by the recommendationsof the Central
Committee for Biological Safety.They reiteratedtheir approval of the
restatingmost of the requirementsforcontainmentthathad been
facility,
outlinedin the originalapproval,but with certainamendmentsto their
implementation. They asked thatadditionalmeasuresbe takento ensure
an LP2 level of physicalcontainmentwas adhered to at all times. For
example,the effectiveness of the filtershad to be testedregularly,and a
recordkept of the results.Increased safetymeasuresforthe treatmentof
thewastewaterwerealso required,as weretestsand evidencethatall E. coli
K12 bacteriaand plasmidscould be completelyinactivatedby heat and/or
chemicalsterilization.The testswereto be done at 120?C for20 minutes,
125?C for5 minutes,and witha 0.005% solutionof chlorinebleach.The
local authorityrequesteda detailedreporton all thesetests [DR, 15]. All
aspects of the treatmentof the wastewaterwererequired,wherepossible,
to be computer-controlled and monitoredto ensurecompleteinactivation

ofbacteriaat all times.They also requiredthatthebuildingsof Fermtecbe

designed to contain the entire contentsof the fermentersshould they
overflow, and thata pump be installedto pump any overflowback into a
containmentvessel [DR, 14]. While the plant was operating,the local
authorityinsisted that there be monthlymicrobiologicalinspectionsof
the area surroundingit to ensure no bacteria had been released. They
asked thata protocolbe establishedthatoutlinedmethodsfordetecting,
analysing,identifying and quantifying microorganismsthat may be acci-
dentallyreleasedfromthefacility. This regimeofprocedureswas proposed
by the local authorityto help hold in place the relationshipbetween
hazards and theirminimizationinscribedby LP2B1 containment.So long
as these associations held, the risk that had emerged fromthe rDNA
debate and that inscribedin the guidelineswould continue to be gen-
eratively(re)performed in the human insulinfacility.
Risk's Realness
In the discussion above, I have shown how the Schnufflerand Hoechst
made different causal relationsbetween hazards and theirminimization
withinthe architectureand operationof the human insulinfacility.I have
argued that it was within this material ordering that differentrisks
emerged.I have emphasizedthe multiplicity of risksin the dispute,as well
as the role played by 'real risk' referentsin establishingdifferent sets of
causal relationsand different risks.The strongestreferent 'real risk'in the
disputewas thatwhichfirstemergedwithinthe rDNA debate and became
inscribedin both the Americanand German guidelinesregulatinggene
technology.The Central Committeefor Biological Safety(re)performed
this referentwhen they allocated an LP2B 1 level of containmentto
Fermtec,and Hoechst soughtto maintainthisreferent in the architecture
and operationof the facility.However, for the Schnuffler, this referent
misconstruedwhatwas importantabout the architecture and operationof
the facility,and the sets of materialrelationsinsideand outsidethefacility
fromwhich risksemerged.They attemptedto build a different referent
'real risk'.In thisattempttheywerelargelyunsuccessful.The Schnuffler's
risks never really materializedin the way that Hoechst's did. This was
because Hoechst's riskswere alreadyso stronglymaterializedin the links
theywereable to buildwithoutcomesoftherDNA debate.In (re)perform-
ing the referent 'real risk'thatemergedwithinthe rDNA debate,Hoechst
were able to generateassociations that held, in part, because the same
referent'real risk' guided the deliberationsof the Central Committee,
and those of the local authority,when they initiallyapproved Fermtec
in 1984.
However, in seeing how the Schnuffler'sand Hoechst's risks were
different, we can also see how theyoverlappedand depended upon one
another.The risksmay have been multiple,but theydid not existin two
mutuallyexclusivezones. They were different but relatedorderingsof the
microworldofthehumaninsulinfacility. Risk'srealnessdepended on how,

ifat all, thesedifferent riskswereto be linkedor separated,and it was with

such trialsof strength thatthedisputebothgeneratedrisksand generalized
them.But how were some riskslinkedand othersseparated,or linkedin
some ways and separated in others? How did the dispute generalize
multiplerisksinto a singular'real risk' of the human insulinfacility? To
answerthisquestionis to engagein a politicsabout how to go on.47This is
whatAnnemarieMol calls 'ontologicalpolitics':a politicsby whichthings
are made to belong to the real.48
In the Hoechst dispute, ontologicalpolitics determinedwhich risks
werelinkedand whichassociationsheld. Hoechst's riskswerecontingently
linkedto the referent 'real risk'in the guidelineswhichemergedfromthe
rDNA debate; whereasthe Schniiffler's risksdid the relationshipbetween
hazards and containmentdifferently, in wayspartiallyseparatedfromthe
guidelines and from the rDNA debate. The Schniiffler, like Hoechst,
maintainedthatrisksdepended upon materialrelationsbetweenhazards
and theirminimizationin containment.In relationto physicalcontain-
ment,theylinkedpotentialaccidents,faultyoperationsand human error
to non-humancomponentsof the facilitysuch as air filters,waste-water
treatmentprocesses, welds in the cooling rods, and 60,000 litres of
geneticallymodifiedbacterial culture.They argued, in relationto bio-
logical containment,that therewere linksbetweenHoechst's E.coli K12
strain,and plasmid vector,and data about E.coli K12 and plasmids that
had been generatedduringtherDNA debate.The Schnuffler proposedsets
of causal relationsthat differedfromthose proposed by Hoechst, the
Central Committeeand the local authority,but these different sets of
causal relationsalso containedentitiesin common.
The choice of how to go on, how thingsshould be made to belong to
the real,was also contingentupon linksmade by the local authority. Their
Report (re)performed the referent 'real risk'foundin the guidelines.Like
the CentralCommitteeand Hoechst, the local authoritysaw thisreferent
as stronglylinked to the architectureand operationof the human insu-
lin facility.However, theyalso recommendedtightersecuritymeasures,
increasedmonitoringand more thoroughrecord-keeping, so as to avertor
avoid the kind of accidentsand errorsthatthe Schnuffler included in the
materiality of theirrisks.The Reportof the local authority generalizedrisk
by,in some ways,separatingthe Schnuffler's risksfromthoseperformedin
the guidelinesand, in otherways,partiallylinkingthem.A realistwould
insiston maintaininga completeseparation,arguingthat therewas only
one rightway to go on, and that was to go with the realityof risk as
determinedby nature.The relativistwould argue that one account of
realitywon out over otherequally valid accounts, and that the outcome
was a politicaldecisionmade by the local authority. However,ontological
politicsmakesexplicita performative accountofrealitythatopenlyacknow-
ledges the location of risk's realness as emergentin the managing of
complexity. This was achievedin the Hoechst disputewithinpracticesthat
linked entities in nature,such as E.coli K12 bacteria,plasmidsand DNA,
withhumans and theirsocial institutions. The Schniiffler's risksinterfered

withthe risksperformedin the initialapprovalof Fermtecby the Central

Committeeand thelocal authority. This interference generatedcomplexity,
whichwas managed as linksweremade betweenrisks,and as associations
held. Risk's realnessemerged,not as somethingalready'out there'to be
discovered,nor as a social constructionor a sociallyrelativechoice of one
overmany(pluralism),but withina processof generalizingriskas singular
and, at the same time, contingentupon links and associationsbetween
multiple,materialand ongoingroutinesofpractice.The realnessof riskin
the disputewas thusgeneratively performed,and would remainso as long
as associationshold.
Notes
I am gratefulto Helen Verranforher insightful
commentson earlierdraftsof thispaper,
and I thankMarilysGuillemin,WarwickAndersonand fouranonymousreviewersfortheir
suggestionsand guidance.
1. AnnemarieMol, 'Missing Links,Making Links:The Performancesof Some
Atheroscleroses',in Marc Berg and AnnemarieMol (eds), Differences in Medicine:
Unraveling Practices, and Bodies(Durham, NC & London: Duke University
Techniques,
Press, 1998), 144-65; AnnemarieMol, 'OntologicalPolitics:A Wordand Some
Questions', in JohnLaw and JohnHassard (eds), ActorNetwork TheoryandAfter
(Oxford:Blackwell,1999), 74-89.
2. For thiswell establishedtenetof actor-network theory,see: Bruno Latour, 'Give Me a
Laboratoryand I will Raise theWorld',in Karin Knorr-Cetinaand Michael Mulkay
(eds), ScienceObserved:Perspectiveson theSocial StudyofScience(London: Sage, 1983),
141-70; Michel Callon, 'The Sociologyof an Actor-network: The Case of the Electric
Vehicle',in Michel Callon, JohnLaw and Arie Rip (eds), MappingtheDynamicsof
Scienceand Technology (London: Macmillan, 1986), 19-34; Michel Callon, 'Some
Elementsof the SociologyofTranslation:Domesticationof the Scallops and the
Fishermenof St Brieuc Bay', in JohnLaw (ed.), Power,Actionand BeliefA New
SociologyofKnowledge? (London: Routledge& Kegan Paul, 1986), 196-233.
3. Helen Verran,Scienceand an AfricanLogic (Chicago, IL: The Universityof Chicago
Press, 2001), 170-73.
4. RS StudyGroup, Report,RiskAnalysis,Perception and Management(London: Royal
Society,1992), 6.
5. National ResearchCouncil, Committeeon the InstitutionalMeans forAssessmentof
Risksto Public Health, RiskAssessment in theFederalGovernment: ManagingtheProcess
(Washington,DC: National AcademyPress, 1983), 7.
6. Sheldon Krimsky,'The Role ofTheory in Risk Studies', in Sheldon Krimskyand
Dominic Golding (eds), Social TheoriesofRisk (Westport,CT: Praeger,1992), 3-22,
at 19-20.
7. A constructivist account of riskunderliesa numberof different approaches.For
instance,Mary Douglas and AaronWildavsky,in Riskand Culture:An Essay on the
SelectionofTechnical and Environmental Dangers(Berkeley:Universityof California
Press, 1982), proposed a culturaltheoryof riskin whichriskis constructedin relation
to the culturalrationalityand organizationalbias of different
societalgroups.This work
was givenfurtherapplicationin Brandon B. Johnsonand VincentT. Covello (eds), The
Social and CulturalConstruction ofRisk: Essayson RiskSelectionand Perception
(Dordrecht:Reidel, 1987). Otheraccounts of riskas a social constructinclude:
BayerischeRuck (ed.), Riskis a Construct: ofRiskPerception
Perceptions (Munich:
Knesebeck, 1983); JudithA. Bradbury,'The PolicyImplicationsof DifferingConcepts
of Risk', Science,Technology,& HumanValues,Vol. 14, No. 4 (Autumn 1989), 380-99;
BrianWynne,'May the Sheep SafelyGraze? A ReflexiveView of the Expert-Lay
KnowledgeDivide', in Scott Lash, BronislawSzerszynskiand BrianWynne(eds), Risk,

Environment and Modernity: Towardsa New Ecology(London: Sage, 1996), 44-83;

Maarten A. Hajer, ThePoliticsofEnvironmental Discourse:EcologicalModernization and
thePolicyProcess(Oxford:Clarendon Press, 1995).
8. For the conceptof a 'circulatingreferent', see Bruno Latour,Pandora'sHope: Essayson
theRealityofScienceStudies(Cambridge,MA: HarvardUniversityPress, 1999), 24-79,
310. I referto "'real risk"referents',as generalizationsthatguide practicesof 'doing
risk'at the local level,and arguethatthereare multiplereferents and multiplerisks.
9. Wolfgangvan den Daele, 'Dealing withthe Risksof GeneticEngineeringas an
Example of "ReflexiveModernization"?',New Geneticsand Society, Vol. 18, No. 1
(April 1999), 65-77, at 70.
10. Here I referto workthatcould be generallydescribedas eitheractor-network theoryor
'after'actor-network theory,such as: Bruno Latour,WeHave NeverBeenModern
(Cambridge,MA: HarvardUniversityPress, 1993); Latour,Pandora'sHope, op. cit.
note 8; JohnLaw, OrganizingModernity (Oxford:Blackwell,1994); and the collections
of essaysin Berg & Mol (eds) and Law & Hassard (eds), op. cit. note 1.
11. Mol (1999), 'OntologicalPolitics',op. cit. note 1, 74.
12. Verran,op. cit. note 3, 94; fora discussionof'clotting',see ibid., 46.
13. This paper arisesout of researchconductedformydoctoraldissertation,see Rosemary
Robins,Representing Risk:An Actor-network AnalysisoftheRecombinant DNA Debateand
theDisputeoverHuman InsulinProduction in Germany(unpublisheddoctoral
dissertation,School of Science & TechnologyStudies,Universityof New SouthWales,
1996). The social and regulatory framingof riskin thisdisputeis the focusof
RosemaryRobins,'OverburdeningRisk: PolicyFrameworksand the Public Uptake of
Gene Technology',PublicUnderstanding ofScience,Vol. 10, No. 1 (January2001),
19-36.
14. PeterNewmark,'Insulin on Tap', Nature,Vol. 299 (23 September1982), 293; Deborah
Shapley,'Human Insulin',Nature,Vol. 300 (11 November1982), 100-01.
15. The procedureis describedin Hoechst Aktiengesellschaft [HA], InsulinProduktion bei
Hoechst- Erfahrungen undPerspektiven (Frankfurt-am-Main: Zentralabteilung
Offentlichkeitsarbeit, 1987); and in Der Regierungsprasident [DR], Der
Widerspruchsbescheid desRegierungsprasidenten in Darmstadt(Darmstadt:Officeof the
Regierungsprasident, 7 July1988), 22. Referencesto subsequentquotationsfromthese
two documentsin the main textof thispaper willbe located in [square brackets],with
the documentsreferred to as 'HA' or 'DR', followedby the relevantpage number(s).
16. See note 15.
17. The two most comprehensivehistoriesof thisperiod are Sheldon Krimsky,Genetic
Alchemy:TheSocial HistoryoftheRecombinant DNA Controversy (Cambridge,MA: MIT
Press, 1982), and Susan Wright,MolecularPolitics:Developing Americanand British
Regulatory PolicyforGeneticEngineering 1972-1982 (Chicago, IL: The Universityof
Chicago Press, 1994).
18. This questionarose priorto the developmentof recombinantDNA techniques,when
Paul Berg and his colleaguesattemptedto use non-rDNA methodsto transportthe
monkeytumourvirusSV40 intoE.coli K12. Concerns about the potentialbiohazards
of such researcheventuallyled Berg to cancel his experiment.A similarincident
occurredat the US National InstituteforAllergiesand InfectiousDiseases (NIAID). In
thiscase, AndrewLewis became concernedabout the distribution to otherlaboratories
of a hybridthathad been constructedbetweenthe SV40 virusand an adenovirusthat
causes respiratory disease in humans.In both cases, the concernwas thatthe modified
E.coli K12 mightbe able to infectpeople workingwiththe organism,and possibly
spread thatinfectionto the widercommunity. Withthe adventof rDNA techniques,
the abilitygeneticallyto modifyE.coli K12 became easier,and the biohazardpotentially
greater.As Susan Wrightpointsout, the abilityof geneticallyengineeredE. coliKl 2 to
become an epidemicpathogenwas a centralfocusof the molecularbiologycommunity
in theirefforts to relaxthe guidelinesthatrestrictedrDNA research.See, in particular
Susan Wright,'Molecular Biologyor Molecular Politics?The Productionof Scientific

Consensus on the Hazards of RecombinantDNA Technology',Social StudiesofScience,

Vol. 16, No. 4 (November 1986), 593-620.
19. For these and otherdetailsof the Committee'scontainmentguidelines,see Krimsky,
op. cit. note 17, esp. at (in turn) 188-90, 183 & 190.
20. Wright,op. cit. note 17, 359-63.
21. For 'trialsof strength',see Bruno Latour, ScienceinAction(Milton Keynes,Bucks.,
UK: Open UniversityPress, 1987), 78, 200.
22. ZentraleKommissionfuirBiologischeSicherheit(ZKBS). This was a national
committeeof expertswhose taskit was to assess the biosafetyrequirementsof
individualresearchprojectsthatused gene technology,and recommendappropriate
levelsof biologicaland physicalcontainment. The membershipof the committee
comprisedscientiststrainedin molecularbiology,microbiology, virologyand other
fieldsallied to gene technology,membersof tradeunions and membersof professional
associations.
23. ZentraleKommissionfuirBiologischeSicherheit,Berichtiiberdie zuriichliegende
Amtsperiode derZentralen Kommission furBiologische Sicherheit,29.09.1981 bis30.06.1988
(Berlin:ZKBS, 1988).
24. HerbertGottweis,Governing Molecules:TheDiscursivePoliticsofGeneticEngineering in
Europeand theUnitedStates(Cambridge,MA: MIT Press, 1998), 137.
25. Bundesministerium fuirForschungund Technologie,Richtlinien zum SchutzvorGefahren
durchin vitroNeukombinierte Nukleinsduren: in der Fassung vom 7. August 1981 (Bonn:
Herausgegebendurchden Bundesminister fiurForschungund Technologie,1981).
26. I willhenceforthuse 'LP2B1' to designatethe containmentlevelsassignedto Fermtec
by the CentralCommitteeforBiological Safety.
27. Hoechst, Fachwissenschaftliche Stellungnahme zurWiderspruchsbegrnndung der
Rechtsanwdlte MeiJ3nerundNeumannvom8.12. und 16.12.1987 (Frankfurt-am-Main:
Hoechst A.G., 1988), 13. Subsequent quotationsfromthisdocumentwillbe
referencedin the textas [Hoechst,page number].
28. At the local level,the Bundesimmissionsschutzgesetz is administeredthroughthe officeof
the Regierungsprasident, a local governmentofficialresponsiblefora sub-unitof the
Land (State) - in thiscase, of Hessen.
29. The firstof Hoechst's factorieswas establishedin the Frankfurt suburbof Hochst in
1863, and it is fromthislocationthatthe companytook its name: see ErnstBaumler,
Die Rotfabriker (Munich: Serie Piper, 1988).
30. There is no directtranslationfor'HoechsterSchnuffler un Maagucker',but it can be
describedas follows:'Hoechster' relatesto the locationof the groupin the suburbof
H6chst, as well as to the activitiesof the group as watchdogsof the Hoechst company;
a 'Schnuffler'is a sleuth,or snooper; and the word'Maagucker' is derivedfromtwo
words- 'Maa', whichis local slang forthe riverMain whichruns throughH6chst, and
'gucker',whichis derivedfromthe verb'gucken',and means to look, or to peep. The
combination'Maagucker',therefore, refersto someone who looks into the riverMain
forsignsof pollution.In summary,the 'HoechsterSchniiffler un Maagucker' are a
group of citizenswho residein the suburbof Hochst and monitorenvironmental
pollutionfromHoechst's Frankfurt premises,particularly in the riverMain and
surroundingareas.
31. HochsterSchnuffler un Maagucker,Keine Gentechnisch Manipulierten Bakterienin
Hdchst(Frankfurt-am-Main: HSuM, 1987), 1.
32. Cases of oppositionsuch as thisare knownin German as Widerspriiche and permitted
underthe German law Venualtungsverfahrensgesetz (VwGO). This law was used by citizen
groupspriorto the Hoechst case, in particularto oppose the buildingof nuclearpower
stations.The Schnuffler lodged threeWidersprnche: one againstFermtec,one against
Chemtec,and anotherin the formof a petitionsignedby over300 citizensagainstthe
facilityas a whole (the latterwas rejected).
33. By the timethe Schnuffler enteredintothismoreformalprocessof opposition,the
local authorityhad approvedChemtec as a trialfacility. The Schnuffler presentedtwo
cases of opposition,one againstFermtecand the otheragainstChemtec.In thispaper,

I focusonlyon the case made againstFermtec,in whichthe risksof gene technology

wereimplicated.
34. See note 27.
35. Lutz MeiB3ner und Hans Neumann, Genehmigungsverfahren HoechstAG, WerkFrankfurt-
Hochst,Produktionsanlage zur HerstellungvonHumaninsulin-Fusionsprotein aus E. coli
(Fermtec)Az.:IV 5/32-53 e 621-FWH -327. Widerspriicheder Herrn Barth,Kirchner,
Goldbergund Schustervom 30.10., 11.1. und 20.11.1987 sowie von Frau Pfahlvom
16.1.1987 (Frankfurt-am-Main: Lutz MeiB3ner & Hans Neumann Rechsanwalte),11.
Subsequent quotationsfromthisdocumentwillbe referencedin the textas [M&N].
36. For example,the firstworst-caseriskexperimentsconductedduringthe rDNA debate
weredesignedto assess the containmentpotentialof E. coliKl 2. In these experiments,
polyomaDNA was insertedintoE. coliKl 2, and thisconstructwas thenused to
populate newborngerm-free mice.The mice weremonitoredforsignsof infection. The
broad aim of the experimentswas to investigate the extentto whichDNA could be
transferred in a functionalstatefromE.coli K12 to mammaliancells undernatural
conditions.See Krimsky,op. cit. note 17, 244-63.
37. See note 35.
38. Here the Schnuffler cited Monica A. Devanas, Devorah Rafaeli-Eshkoland Guenther
Stotzky,'Survivalof Plasmid-containing Strainsof Escherichia coliin Soil: Effectof
Plasmid Size and Nutrientson Survivalof Hosts and Maintenanceof Plasmids',
Current Microbiology, Vol. 13 (1986), 269-77, and Monica A. Devanas and Guenther
Stotzky,'Fate in Soil of a RecombinantPlasmid Carryinga Drosophila Gene', ibid.,
279-83.
39. Here the Schnuffler cited K.P. Flint,'The Long-termSurvivalof Escherichia coliin
RiverWater',JournalofAppliedBacteriology, Vol. 63 (1987), 261-70.
40. The Schnuffler cited Devanas, Rafaeli-Eshkol& Stotzky,op. cit. note 38; two papers
by G.K. Bissonnette,J.J.Jezeski,G.A. McFeters and D.G. Stuart,'Influenceof
EnvironmentalStresson Enumerationof IndicatorBacteriafromNaturalWaters',
AppliedMicrobiology, Vol. 29, No. 2 (February1975), 186-94, and 'Evaluationof
RecoveryMethods to Detect Coliformsin Water',Appliedand Environmental
Microbiology,Vol. 33, No. 3 (March 1977), 590-95; and Gordon A. McFeters,Susan
C. Cameron and MarkW. LeChevallier,'Influenceof Diluents,Media and Membrane
Filterson Detection of InjuredWaterborneColiformBacteria',ibid.,Vol.43, No. 1
(January1982), 97-103.
41. Both Krimsky,op. cit. note 17, and Wright,op. cit. notes 17 & 18, arguethatscientific
consensusabout thebiohazardsposed by the use of E.coli K12 as a host organismin
rDNA research,was the outcome of a concertedeffortto allaypublic concern,relax
the guidelinesand staveofflegislation.In particular,Wright,op. cit. note 18, provides
convincingevidenceforthisin a detailedaccount of threemeetingsoverthe course of
whichit was decided thatE. coliK12 could not become an epidemicpathogen.
42. Both Krimskyand Wright,op. cit. notes 17 & 18, cite such evidence.
43. One reference,as citedby the Schnuffler, was S.B. Levy and B. Marshall,'Survivalof
E.coli Host-VectorSystem',Recombinant DNA Technical Bulletin(July1979), 77.
However,it became clear thatthiscitationwas incorrectwhen I consultedthe relevant
issue of thisjournal,since the articleis not publishedthere.The closestreferenceI
could findis an articleby StuartB. Levy,Bonnie Marshall and Debra Rowse-Eagle,
'Survivalof Escherichia coliin Host-VectorSystemsin the Mammalian Intestine',
Science,Vol. 209 (18 July1980), 391-94. This reportsan experimentwhichused the
same plasmidconstructs,strainof E. coliKl 2, and investigated the same questionsas
thoseforwhichthe Schnuffler cited Levy & Marshall (ibid.). In respondingto the
Schniiffler'sclaims,Hoechst cited the Levy,Marshall& Rowse-Eagle (1980) paper. In
relationto thisclaim,the Schnuffler also cited P.H. Williams,'PlasmidTransferin the
Human Alimentary Tract', FEMS Microbiology Vol. 2 (1977), 91-95.
Letters,
44. Here Hoechst cited S.B. Levy and B. Marshall,'Risk AssessmentStudies of E.coli
Host-VectorSystem',Recombinant DNA Technical Bulletin,Vol. 4, No. 3 (September
1981), 91-98.

Robtns: The Realness of Risk: Gene Technologyin Germany 35
45. The papers citedby the Schnuffler to supportthisaspect of theirargumentwere:

J.D. Anderson,'The Effectof R-factorCarriageon the Survivalof Escherichia coliin the
Human Intestine',JournalofMedicalMicrobiology, Vol. 7, No. 1 (February1974),
85-90; Williams,op. cit. note 43; G. Stotskyand V.N. Krasovsky,'Ecological Factors
thatAffectthe Survival,Establishment,Growthand Genetic Recombinationof
Microbes in Natural Habitats',in S.B. Levy et al. (eds), ProceedingsoftheInternational
PlasmidConference on MolecularBiology,Pathogenicityand EcologyofBacterialPlasmids
(New York:Plenum Press, 1981), 31-42; RolfFreter,RolfR. Freterand Howard
Brickner,'Experimentaland MathematicalModels of E.coli PlasmidTransferIn Vitro
and In Vivo', Infectionand Immunity, Vol. 39. No. 1 (January1983), 60-84; and M.M.
Levine et al., 'RecombinantDNA RiskAssessmentStudies in Man: Efficacyof Poorly
Mobilizable Plasmids in Biological Containment',Recombinant DNA Technical Bulletin,
Vol. 6. No. 3 (September1983), 89-97.
46. Hoechst cited thesepapers as V. Petrocheilouand M.H. Richmond,'Absence of
Plasmid or EscherichiacoliK-12 Infectionamong LaboratoryPersonnelEngaged in
r-PlasmidResearch', Gene,Vol. 2 (1977), 323-27; Levy,Marshall & Rowse-Eagle
(1980), op. cit. note 43; Bonnie Marshall,Susan Schluederberg,ChikanoriTachibana
and StuartB. Levy,'Survivaland Transferin the Human Gut of PoorlyMobilizable
(pBR322) and ofTransferablePlasmids fromthe Same CarrierE.coli', Gene,Vol. 14
(1981), 145-54; Levy & Marshall,op. cit. note 44; Levine et al., op. cit. note 45.
47. Verran,op. cit. note 3, 117-19.
48. Mol (1999), 'OntologicalPolitics',op. cit. note 1.
RosemaryRobinsis a Lecturerinthe Departmentof History and Philosophy

of Scienceat the University
of Melbourne,Australia.Herteachingand
researchinterestsfocuson the sociologyof risk,and the public
understanding of gene technologyand genetics.
Address:Departmentof Historyand Philosophy of Science,University
of
Melbourne,Parkville,
Victoria3010,Australia;fax:+61 3 8344 7959;
email:rmrobins@unimelb.edu.au


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The Realness of Risk

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The Realness of Risk: Gene Technology in Germany

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