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Nano Today (2015) 10, 6—10 Available online at www.sciencedirect.com ScienceDirect journa l h om epa ge: www.elsevier.com/locate/nanotoday NEWS AND OPINIONS The challenges of nanotechnology risk management Tarek R. Fadel a , Jeffery A. Steevens b , Treye A. Thomas c , Igor Linkov b,∗ a International Technology Research Institute (ITRI, Inc.), Linthicum, MD, USA b U.S. Army Engineer Research and Development Center, Vicksburg, MS, USA c Consumer Product Safety Commission, Bethesda, MD, USA Received 11 March 2014; received in revised form 7 September 2014; accepted 10 September 2014 Available online 22 October 2014 KEYWORDS Risk management; Risk assessment; Decision analysis; Policy; Nanomaterials; Regulations Summary Recent developments in the design of advanced materials have furthered inter- est in the commercialization of new technologies. Central to this rapid technology revolution is the consideration of the potential environmental, health, and safety (EHS) risks associated with nanomaterials. Risk assessment has been proposed as a primary method to evaluate EHS risk and decision making, where risk assessment practitioners seek to understand what can go wrong, its likelihood of occurrence, and the ultimate consequences if it should arise. Here, we outlined recent efforts geared toward risk assessment for nanotechnologies and nanomaterials, and discuss the challenges associated with providing accurate risk information to policymakers and regulators. Risk assessment that includes analytical approaches will provide decision mak- ers with adaptive guidance regarding how to balance risks with technological benefits and costs, communicate those trade-offs, and change nanomaterial design toward sustainable nanotech- nology. Published by Elsevier Ltd. The thoughts and opinions expressed here are those of the individual contributors alone and do not necessarily reflect the views of the National Nanotechnology Initiative or the U.S. Federal Government. ∗ Corresponding author. Tel.: +1 6172339869. E-mail address: [email protected] (I. Linkov). Introduction Risk assessment has traditionally been thought of as the evaluation of what can go wrong, how likely it is to happen, and the consequences of it happening [1]. As a regulatory platform, risk assessment has been the guiding principle for the evaluation of environmental and product risks, includ- ing nano-enabled technologies [2]. In the case of chemicals and nanomaterials, risk assessment has historically relied on detailed, empirical data for exposure and hazard (e.g., http://dx.doi.org/10.1016/j.nantod.2014.09.008 1748-0132/Published by Elsevier Ltd.
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Nano Today (2015) 10,610Availableonlineatwww.sciencedirect.comScienceDirectj our nal homepage: www. el sevi er . com/ l ocat e/ nanot odayNEWS AND OPINIONSThechallengesofnanotechnologyriskmanagementTarekR.Fadela,JefferyA.Steevensb,TreyeA.Thomasc,IgorLinkovb,aInternationalTechnologyResearchInstitute(ITRI,Inc.),Linthicum,MD,USAbU.S.ArmyEngineerResearchandDevelopmentCenter,Vicksburg,MS,USAcConsumerProductSafetyCommission,Bethesda,MD,USAReceived11March2014;receivedinrevisedform7September2014;accepted10September2014Available online22October2014KEYWORDSRiskmanagement;Riskassessment;Decisionanalysis;Policy;Nanomaterials;RegulationsSummaryRecentdevelopmentsinthedesignofadvancedmaterialshavefurtheredinter-est inthecommercializationofnewtechnologies.Centraltothisrapidtechnologyrevolutionis theconsiderationofthepotentialenvironmental,health,andsafety(EHS)risksassociatedwith nanomaterials.RiskassessmenthasbeenproposedasaprimarymethodtoevaluateEHSrisk anddecisionmaking,whereriskassessmentpractitionersseektounderstandwhatcangowrong, itslikelihoodofoccurrence,andtheultimateconsequencesifitshouldarise.Here,weoutlined recenteffortsgearedtowardriskassessmentfornanotechnologiesandnanomaterials,and discussthechallengesassociatedwithprovidingaccurateriskinformationtopolicymakersand regulators.Riskassessmentthatincludesanalyticalapproacheswillprovidedecisionmak-ers withadaptiveguidanceregardinghowtobalanceriskswithtechnologicalbenetsandcosts,communicatethosetrade-offs,andchangenanomaterialdesigntowardsustainablenanotech-nology.PublishedbyElsevierLtd.The thoughts and opinions expressed here are those of theindividual contributors alone and do not necessarily reect theviews of the National Nanotechnology Initiative or the U.S. FederalGovernment.Corresponding author. Tel.: +1 6172339869.E-mail address: [email protected] (I. Linkov).IntroductionRiskassessmenthastraditionallybeenthoughtofastheevaluationofwhatcangowrong,howlikelyitistohappen,andtheconsequencesofithappening[1]. Asaregulatoryplatform,riskassessmenthasbeentheguidingprinciplefortheevaluationofenvironmentalandproductrisks,includ-ingnano-enabledtechnologies[2].Inthecaseofchemicalsandnanomaterials,riskassessmenthashistoricallyreliedondetailed,empiricaldataforexposureandhazard(e.g.,http://dx.doi.org/10.1016/j.nantod.2014.09.0081748-0132/Published by Elsevier Ltd.Thechallengesofnanotechnologyriskmanagement7doseresponsemodels,whichdescribethechangeineffectonasystemcausedbydifferinglevelsofexposuretoastressoroveracertainexposuretime).Thismethodofriskassessment,referredtoasabottom-upapproach,maynotbeeffectiveinresearchingtherisksoffast-evolving,mod-ernmaterialsandtechnologies,asevidencealonedoesnottypicallyleadtoaspeciccourseofaction.Objective-drivenapproaches,referredtohereastop-downmethods,relyontheacquisitionofinformationandsynthesisfromdecisionmakerstodriveactions.Top-downmethodscanimproveandexpeditetheriskassessmentprocessbyinte-gratingtechnicalinformationandexpertjudgmentonanemergingtechnologywithhumanperceptionsandvalues,thusallowingstakeholderstoassesstherelativemeritsofmultiplerisk-reductionalternatives.However,animpor-tantremainingchallengeistodeterminehowtointegratebothbottom-upandtop-downapproachestofacilitaterisk-informeddecision-making[3].TheU.S.regulatorycommunityandnanotechnologyindustrycontinuetoassessvalidatedandreliablescience-basedmethodsandtoolstoaugmentexistingapproachesforriskanalysisandregulationofnanomaterials.Signicantglobaleffortsbygovernmentandprivatesectorstakehol-derstocollectEHSriskinformationhaveresultedinalargevolumeofdataconcerningnanomaterialfateandeffects.Thevalueandapplicationofthisinformationtorelevantpolicymakershasbeenthesubjectofmultiplenationalandinternationalefforts,includingfourworkshopsorganizedbytheNNIin20092010[4]. Variousstakeholdercommunitiessuchasindustry,workers,consumers,andnon-governmentorganizationsneedassurancethatthesenovelmaterialsaresafeforuse.Effortsbygovernmentdecisionmakersandpri-vatesectorstakeholderstocollectEHSinformationhavehelpedbuildalargevolumeofdataconcerningnanomaterialfateandeffects.Forexample,federalagencyapproachestoriskassessmentstresstheimportanceofbasinganyriskdecisionsonthebestavailablescienticdata.Traditionalbottom-upapproachestoriskassessmentincludegaininginformationregardingthetoxicityofacompoundanddeter-mininglimitsforexposureanduptakeintothebody.Suchresearchmustbefollowedbythedevelopmentofrobustmethodsforcharacterizingandquantifyingexposurestohumansandtoorganismsintheenvironment[5].In2009,NNIagenciesreviewedthe2008EHSResearchStrategyandtheinformationanddatainEHSandtheethical,legal,andsocietalimplications(ELSI)arenatoconsiderthebestpathforwardfornanotechnology.The2008EHSResearchStrategydocumentrepresentedtheculminationofacomprehensiveeffortledbytheNano-technologyEnvironmentalandHealthImplications(NEHI)WorkingGroupundertheNationalScienceandTechnologyCouncilsNanoscaleScience,Engineering,andTechnology(NSET)SubcommitteetoprovideguidancetotheNNIFederalagenciesproducingscienticinformationforriskmanage-ment,regulatorydecision-making,productuse,researchplanning,andpublicoutreach.Duringthisreview,the2009nanotechnologyEHS(nanoEHS)workshopseriesconvenedexpertsfromindustry,academia,andtheUnitedStatesFederalGovernmenttosharethelatestinformationandnewestdevelopments,thecurrentstate-of-the-science,andresearchgapsinthenanotechnology-relatedEHSeld[6].Forexample,theNNI2010Capstoneworkshop[7]concludedBottom-Up ObjectivesRisk Assessment2013 NNI R3 Workshop Objectives Analyze the role of comparative risk assessment in these evaluations, including decision analysis tools and gap analysis toolsTop-Down ObjectivesDecision Analysis Identify stakeholder values and risk perceptions that inform their decision making, and opportunitiesto integrate these values and perceptions into a practical framework for risk communication Discuss current risk management practices in the emerging technology communities Determine steps to improve the linkage of risk assessment to risk management and risk communication Understand the state of practice for the consideration of risk used by industry, academia, and the general publicFigure12013NNIR3workshopobjectives.thatexistingapproachestoassessenvironmentalrisksofnanomaterialsorestablishstandardsaredata-intensive,time-consuming,andexpensive.Overall,theknowledgegleanedfromthenanoEHSworkshopserieswascriticaltothedevelopmentofthe2011NNIEHSResearchStrategy.Thisstrategydocumentidentiedimportantdataneedsintheareasofnanomaterialmeasurementinfrastructure,riskassessmentandmanagementmethods,humanhealth,theenvironment,informatics,andhumanexposureassess-ment.AsafollowuptothepreviouslymentionedNNIEHSwork-shopseries,the2013NNInanoEHSstakeholderworkshop1wasdesignedspecicallytofacilitatediscussionamongvariousstakeholdersofapproaches,tools,andmethodsusedtoassess,manage,andcommunicatethepoten-tialrisksofnanomaterialsandnanotechnology-enabledproducts[8](seeFig.1).Approximatelytwohundredpar-ticipantsengagedintheworkshop,includingoverahundredparticipantsonsiteandanotherhundredremotely.Par-ticipantsincludedstakeholdersfrominsurancecompanies,industry,labororganizations,academia,government,non-governmentalorganizations,andothermembersofthepublic.Stakeholdercommunitiesemphasizedtheimpor-tanceofsharingtherightamountofinformationtosupporttop-downapproachesforrisk-baseddecisionsonnano-materials[9]. Participantsdiscussedtheimportanceofprovidingsufcientinformationonnanomaterial-containingproductsinsafetydatasheetsinordertoprotectwork-ers[10].Inputfromthebusinesscommunitycalledforthedevelopmentofbestpracticesforagenciestocom-municatewithsmallbusinesses.Forexample,stakeholders1The NNI Stakeholder Perspectives on the Perception, Assess-ment, and Management of the Potential Risks of Nanotechnologyworkshop, September 1011, 2013.8T.R.Fadeletal.suggestedthecreationofarepositoryofinformation(withlinkstomorein-depthinformation)thatincludesguidancedocumentsandotherresourcestoaidthesmallbusinesscommunityinmakinginformeddecisionswhenenter-ingthenanotechnologymarket.Furthermore,participantshighlightedtheimportanceofindependent,thirdpartyvalidationofdatatofacilitaterisk-baseddecisions,espe-ciallyregardingcommercializingnanotechnology-enabledplatforms(theNanotechnologyCharacterizationLaboratoryisagoodexampleofsuchefforts)[11].Exposureassess-mentwasalsodiscussedasapriorityresearchareaforriskcharacterizationofengineerednanomaterials.Workshopattendeesultimatelyrecommendedintegrationofhazard,exposure,andeffectsdata(includingmodels)withinthetra-ditionalriskassessmentparadigm.Thisistobecoupledwithanunderstandingofstakeholderneedsandacomparativeassessmentofindividualriskmetricsthroughtheproductlifecycleusingdecision-analyticaltools.Duetothecom-plexnatureofnanotechnologies,severalrequirementswerediscussedsuchastechniquestoquantifyparticlesinvivoandthereleaseofparticlesfromnanotechnologies.Finally,theuseofalife-cycleapproachwasdescribedinseveralexamplestoguidethecharacterizationofreleases.Effortstomeetthesedataneedsareongoing,andasignicantamountofnewdataonthetoxicitypotentialofnanomaterialsisnowavailable.TheNationalInstituteofOccupationalSafetyandHealth(NIOSH)continuestoissueCurrentIntelligenceBulletinstodisseminatenewsci-enticinformationaboutpotentialoccupationalhazardsofnanomaterials(forexample,carbonnanotubes[12]).Globalefforts,includingthoseoftheOECDandotherbodies[13],havedevelopedguidelinesforimprovingthedataqualityincludingrecommendationsforadequatelycharacterizingnanomaterialspriortotoxicologicalstudiesanddevelopingrobust,validatedmethodsforcharacterizingandquantify-ingnanomaterialsinexperimentalmedia,tissues,andcells.Effortsintheprivatesectorhavealsofocusedonthedevel-opmentofnewmethodstoestimatecommercialrisksuchastheZurichsNanotechnologyExposureProtocol(ZNEP),whichanalyzesmaterialcharacteristics,manufacturingpro-cesses,relevantcommercialapplications,exposurecontrolmeasures,andthescienticandregulatoryinformationtocreateanindividualriskrating[14].Newapproachesfortoxicityevaluation(suchashigh-throughputscreening)havebeenidentiedasmethodstoacceleratethedevelopmentofdata,aswellasmeth-odstoshareandevaluatethedataproducedinthesestudies.Thesedata-sharingmethodsincludemodelstopri-oritizematerialsforfurthertestingandevaluation,andfullycuratedrepositories(suchastheNanomaterialRegistry[15]) thatarchiveresearchdataonnanomaterialsandtheirbiologicalandenvironmentalimplicationstoimprovesubse-quentapproachestotoxicityandexposurestudies.Finally,advancesinmetrologyhaveresultedinnewmethodstocharacterizereleasesofnanomaterialsintheenvironmen-talmedia(e.g.,airandwater),transformation,andtheiruptakeintothebody.Discussionamongstmeetingparticipantsmovedbeyondstrategizingresearchneedsfornanotechnologyriskanalysistofocusmoreonthecurrenttoolsandmethodsadoptedbynon-Federalstakeholdersinmakingrisk-baseddeci-sionsonnanomaterials.Forexample,theplenarysessionfeaturedperspectivesfromvariouscommunitiesoncurrentapproachesforrisk-baseddecisions.Anon-governmentalrepresentativediscussedtheuseofacomprehensivesystem-atichazardscreenmethodfornanomaterials(theNanosilverGreenScreenTMhazardlevelscreeningassessmentofnanosil-verandsilvergreen[16]) andprovidedevidencethatsomenanomaterialscanbeassessedforhazards,althoughspe-cicdatagapsstillneedtobelled.TheInternationalLifeScienceInstitute(ILSI)effort,Nanorelease,aimstodeveloptechniquestoquantifyreleaseofparticlesfromacarbonnanotubecompositeandinformexposureassess-ment[17,18]. Intheworkplaceenvironment,toolssuchastheNIOSHApproachestoSafeNanotechnology[19]andthecontrolbandingNanotool(forthecriticalevaluationofengi-neerednanomaterialsafetydatasheets)[20]wereidentiedasexamplesthatfacilitatedriskassessment.Casestudiespresentedattheworkshopusedexposurecharacterizationinformationtodevelopbestmanagementpracticestoman-ageuncertainrisks.Uncertaintyintheassessmentprocesswasoftenassociatedwithalackofstandardmethodsortestguidelines,limitationsinanalyticalinstruments,andtheinabilitytopredictreleasesofatechnologyinearlystagesofdevelopment.Industrystakeholdersdescribedaconser-vativeapproachforworkerprotection,whereinsituationsoflimiteddataorstandardizedmethodswereunavailable,thenbestmanagementpracticeswereinstitutedtoensureworkersafety.ConclusionEffortstoengagestakeholdersinpublicvenuessuchasthe2013NNIworkshoponthePerception,Assessment,andManagementofthePotentialRisksofNanotechnol-ogyremainanessentialtooltoguidedecisionmakersintheresponsibledevelopmentofnanotechnologies.Severalimportanttopicsemergedfromtheworkshop:theplenarysessions,forexample,emphasizedtheneedforimprovedriskmanagementandcommunicationprocessesthroughoutthesupplychain(e.g.,theuseofmorecompletesafetydatasheets).Comparativeriskassessmentmodelswerealsoemphasized,aswellastheneedforrepositoriesofrisk-basedinformationonnanomaterials.Additionalfutureresearchareasincludedthedevelopmentoftoolsandmeth-ods(includingmodels)foraccuratelyassessingexposureandthepotentialrisksofnanomaterials;improveddataqualityfornanomaterialsriskassessment;theresearchonEngineering Design Mul-Criteria Decision Analysis Life Cycle Analysis RiskAnalysis Informaon Integraon Needs Figure2Integrationofriskandlifecycleanalysestoguideengineeringdesignusingmulticriteriadecisionanalysis(after[21]).Thechallengesofnanotechnologyriskmanagement9categorizingnanomaterialstosupportriskassessment,andthedevelopmentofaregulatoryframeworkforthesafedevelopmentofnano-enabledcommercialproducts.Suchactivitiesarenecessarytohelpguidethenextgenerationsofsustainablenano-enabledproductdesignsandfacilitatetheintegrationoflifecycleandmulti-criteriadecisionanalyses(Fig.2).References[1] S. Kaplan, B.J. Garrick, Risk Anal. 1 (March (1)) (1981) 1127.[2] I. Linkov, F.K. Satterstrom, J.C.J. Monica, S. Foss, Nanotechnol.Law Bus. 6 (2009) 203.[3] I. Linkov, E. Anklam, Z.A. Collier, D. DiMase, O. Renn, Environ.Syst. Decis. 34 (March (1)) (2014) 134137.[4] NNI Releases Four Workshop Reports from the nanoEHS Series| Nano [Online], available at: http://www.nano.gov/node/648(accessed 05.08.14).[5] J.P. Holdren, C.R. Sunstein, I.A. Siddiqui, Policy Principles forthe U.S. Decision-Making Concerning Regulation and Oversightof Applications of Nanotechnology and Nanomaterials, 2011,January.[6] nanoEHS Workshop Series Reports | Nano [Online], available at:http://nano.gov/node/647 (accessed 05.08.14).[7] Capstone Meeting: Risk Management Methods & Ethical, Legal,and Societal Implications of Nanotechnology | Nano, 30-Mar-2010 [Online], available at: http://www.nano.gov/events/meetings-workshops/capstone (accessed 05.08.14).[8] Stakeholder Perspectives on the Perception, Assessment, andManagement of the Potential Risks of Nanotechnology (R3Workshop) | Nano [Online], available at: http://www.nano.gov/node/1025 (accessed 05.08.14).[9] Multiple Criteria Decision Analysis An Integrated Approach.[10] R. Iafolla, Safety Data Sheets Often Fail Workers WhoHandle Nanomaterials, Union Ofcial Says Bloomberg BNA, 12-Sep-2013 [Online], available at: http://www.bna.com/safety-data-sheets-n17179877015/ (accessed 05.08.14).[11] Nanotechnology Characterization Lab [Online], available at:http://ncl.cancer.gov/ (accessed 05.08.14).[12] Current Intelligence Bulletin 65: Occupational Exposure to Car-bon Nanotubes and Nanober, Centers for Disease Control andPrevention, 2013.[13] Safety of Manufactured Nanomaterials OECD [Online],available at: http://www.oecd.org/science/nanosafety/publicationsintheseriesonthesafetyofmanufacturednano-materials.htm (accessed 05.08.14).[14] Zurich, Insight on Nanotechnology, 2009.[15] Nanomaterial Registry [Online], available at: https://www.nanomaterialregistry.org/ (accessed 05.08.14).[16] Natural Resources Defense Council, Nanosilver GreenScreen.[17] The International Life Sciences Institute, NanoRelease Con-sumer Products [Online], available at: http://www.ilsi.org/ResearchFoundation/RSIA/Pages/NanoRelease1.aspx(accessed 05.08.14).[18] B. Nowack, R.M. David, H. Fissan, H. Morris, J.A. Shatkin, M.Stintz, R. Zepp, D. Brouwer, Environ. Int. 59 (September) (2013)111.[19] CDC NIOSH Publications and Products Approachesto Safe Nanotechnology: Managing the Health and SafetyConcerns Associated with Engineered Nanomaterials(2009-125) [Online], available at: http://www.cdc.gov/niosh/docs/2009-125/ (accessed 05.08.14).[20] D.M. Zalk, S.Y. Paik, P. Swuste, J. Nanopart. Res. 11 (October(7)) (2009) 16851704.[21] D. Eddy, S. Krishnamurty, I. Grosse, J. Wileden, P. Witherell, K.Lewis, ASME J. Comput. Inf. Sci. Eng. 14 (2014), 021011-1.Dr. Tarek Fadel is a Staff Scientist at theNational Nanotechnology Coordination Ofceand the Executive Secretary for the NanoscaleScience, Engineering, and Technology (NSET)Subcommittee of the White Houses NationalScience and Technology Council (NSTC). Dr.Fadel is also Vice-President for Research atthe International Technology Research Insti-tute. He previously held positions as a ProcessEngineer at LSI Logic, and Product and Sys-tems Interaction Engineer at Hewlett PackardCorp. Dr. Fadel holds chemical engineering degrees from Ore-gon State University and Yale University where he obtained adoctorate in 2011. After graduation, he continued at Yale as a post-doctoral researcher developing nanoscale biomaterials for cancerimmunotherapy. Dr. Fadel is lead author in several peer-reviewedpublications in the elds of nanomedicine, cancer immunotherapy,and biophysics. As a fellow for Yales Advanced Graduate Leader-ship Program, he acquired business and entrepreneurial experienceat the Yale School of Management. Dr. Fadel was the recipient ofthe Yale Harding Bliss Prize presented annually to a graduate stu-dent who has done the most to further the intellectual life withinthe School of Engineering & Applied Science.Dr. Jeffery Steevens is a Senior Scien-tist at the U.S. Army Engineer Researchand Development Center (ERDC) in Vicks-burg MS, USA. He received his Ph.D. fromthe Department of Pharmacology and Toxico-logy at the University of Mississippi in 1999.He currently provides the technical guidancefor the Armys Environmental Quality andInstallations Research Program. His researchinterests include life cycle analysis, environ-mental risks of engineered nanomaterials,and use of advanced materials for sensing and remediation.Dr. Thomas is a toxicologist and leader ofthe Chemical Hazards Program team in theU.S. Consumer Product Safety Commissions(CPSC) Ofce of Hazard Identication andReduction. His duties include establishing pri-orities and projects to identify and mitigatepotential health risks to consumers resultingfrom chemical exposures during product use.Dr. Thomas has conducted comprehensiveexposure assessment studies of chemicals inconsumer products and quantied the poten-tial health risks to consumers exposed to these chemicals. Dr.Thomas is responsible for developing agency activities and policyfor nanotechnology. Dr. Thomas has served as a CPSC representativeon a number of nanotechnology committees including the ILSI/HESINanomaterial Environmental, Health, and Safety Subcommittee,the Federal NSET and NEHI sub-committees, and the InternationalCouncil on Nanotechnology (ICON).10T.R.Fadeletal.Dr. Igor Linkov is the Risk and DecisionScience Focus Area Lead with the U.S.Army Engineer Research and DevelopmentCenter, and an Adjunct Professor of Engi-neering and Public Policy with CarnegieMellon University. He is working on integrat-ing decision-analytical and risk analysis toolsto assess risk of emerging technologies andthreats. Dr. Linkov has served as an Armyrepresentative on the National Nanotechnol-ogy Initiative NEHI sub-committee. He haspublished widely on emerging technologies, modeling, policy andrisk analysis, including 14 books and over 200 peer-reviewed papersand book chapters. He is the recipient of two Army medals foroutstanding civilian service. He is the recipient of the 2005 SRAChauncey Starr Award for exceptional contribution to Risk Analysis,SRA Fellow award and was an elected SRA Councilor (20092013).
