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Science, Risk. and Public PolicvAuthor(s)' William D. RuckelsliausSounce:Scienee,New Series, VoI. 221, No. 4615 (Sep.9, 19S3),Published by: American Association fo r the Advancement ofSta bl e URL : htp:ljyw.w.jsrclglgAteble/ 6?I 5 1.jAeeessed:3l /OB 2OO9 13:54pp. 1026-1028Science

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38. R. T. Sauer,R. R. Yocum, R. F. Doolittle.M.Irqyl., C. O. Pabo, Nature (London) 298, 447(r982).39. B. von Wilken-Bergmann nd B. Mller-Hill,Proc.Natl. Acad. Sci. U.S.A. 79,2427 1992).40. H. Nick et al., Proc. Natl, Acad, Sci. U.S.A.79,218(l982ri H. Nick ef al.,J. Mol. Bol, t6t.417 1982);K. Arndt, H. Nick, F. Boscheli, p.Lu, J. Sadler, bid., p.439.,R. Kapteinand K.Wuthrich,personal bmmunication.4 l . T . A. Steitz, . H, Ohlendorf, . B. McKay,W.F. Anderson, B. W. Matthews, Proc, Natl.Acad. Sci. U.S.A. 79,3097 1982).42 . D. L Ohlendorfand B. W. Matthews.unDub-lisheddata.43. .T. Weber,D.B. McKay,T. A.Steitz,NucleicAcids Res.10, 085 1982).44. D. H. Ohlendorf,W. F. Anderson,B. W. Mat-thews, . Mal. Evol.19, 10 9 1983).

45. D. H. Ohlendorf,W. F.,{,nderson, . Lewis, C.O. Pabo, B. W. Matthews,J. Mol. Biol., inDress.46. i. C. Wang, M. D. Barkley, S. Bourgeois,Nature(London)251,247 1974).47. T. Maniatisand M. Ptashne.Proc. Natl. Acad.Sci. U..S.A. 0, l53t (1973).48. N. C. Seeman, . M. Rosenber g, . Rich, bid.73 , 80 4 (l97ri C. Hlene,FEBS Lett. 74 , l00977\.49. P, H. von Hippel, in Biologcal Regulation and.Development, . F. Goldberger,Ed. (Ptenum,New York, 1979), .279.50. M. H. Caruthers,Acc. Chem. Res, 13, 1550980).51 . O. G. Berg,R. B. Winter,P. H. von Hippel,Biochemistry 0,6929 1981);R. B. Winter an dP. H. vo n Hippel, d..p. 6948. . B. Winter,O. G, Berg,P. H, vo n Hippel, b id.,p. 6961.

52 . L. Guarente,J. S. Nye, A. Hochschild,M.Ptashne, roc. Natl. Acad. Sci. U.5.A.79.274( 982).53 . A. Hochschild,N. Irwin, M. Ptashne,Cel/ 32,3 1 9 1 9 8 3 ) .54. D. K, HawleyandW. R. McClure, . Mol. BioI.r57 493 t982); Cell 32,327 (1983).55. We thank R. T. Sauer or communicating esultsin advance fpublication ndC. O. Pabo nd M.Ptashnefor helpful comments on the manu-script. Supported in part by NIH grantsGM28l38 and GM30894 Y.T.) and GM20066(B.W.M.), a grant from the M. J. MurdockCharitable ]'rustt NSF grant PCM-801431(B.W.M.), a granl from thi CanadianMedicalResearchCouncil hrough he MRC Group onProteinStructureand Function W,F.A.), an dan NIH postdoctoralellowship D.H.O.).* Address orrespondenceo B. W. Matthews.

William D. Ruckelshauss Administrator f theU.S. EnvironmentalProtectionAqencv.Washine-ton, D.C. 20460. his article s baied n a talk egave at the National Academy of Sciences,Wash-ington,D.C., on 22June 1983.

people are worried about public healthand about economicsurvival,and egiti-mately so, but we must all reject theemotionalism hat surroundshe currentdiscourseand rescueourselves rom theparalysisof honestpublia policy that itbreeds.I believe that part of the solution toour distress ies with the idea hat disci-plined minds cangrapplewith ignoranceand sometimeswin: the ideaof science.We will not recover our equilibriumwithout a concertedefort to more effec-tively engage he scientificcommunity.Frankly, we are not going o be able oemerge rom our current troubles with-out a much improved level of public

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democratic echnologicalsociety mustresolve he dissonance etweenscienceand the creationof public policy, No-where s this more troublesomehan inthe formal assessmentf risk-the esti-mationof the association etweenexpo-sure o a substance nd the ncidenceofsomedisease, asedon scientifig ata.Science nd the Law at EPA

Here is how the problem emergesatthe EnvironmentalProtectionAgency.EPA is an instrumentof public policy,whosemission s to protect the publichealthand the environment n the man-

ner aid down by its statutes. hat man-ner s to set standards nd enforce hem.and our enforcement owersare strongandpervasive.But the standards e set,whether technology-or health-related,must have a soundscientificbase.Scienceand the law are hus partnersat EPA, but uneasypartners.The mainreason or the uneasinessies, think, inthe conflict between the way sciencereally works and the public's thirst forcertitude hat s written nto EPA's laws.Science hriveson uncertainty.The bestyoung scientists lock into fields wheregreat questionshave been asked butnothing s known, The greatest riumphof a scientist s the crucial experimentthat shatters he certaintiesof the pastand opensup rich new pastures f igno-rance.But EPA's laws often assume.ndeeddemand, certaintyof protection reaterthan sciencecan providewith the cur-rent stateof knowledge. he awsdo nomore than reflect what the public be-lievesand what it often hears rom peo-ple with scientificcredentialson the 6o'clock news. The public thinks weknow what all the bad pollutants are,preciselywhat adversehealth or envi-ronmental efects .they cause, how tomeasure hem exactlyand control themabsolutely.Of course, the public andsometimeshe aw are wrong,but not al lwrong. We do know a greatdeal aboutsomepollutants and we have controlledthem effectivelyby using he tools of theCleanAir Act and he CleanWaterAct.These are the pollutants or which thescientiflccommunitycan set safe evelsand marginsof safety or sensitive opu-lations. If this were the case for al lpollutants,we could breathemoreeasily(in both senses f the phrase);but it isnot so.

Summary. climate f earnowdominateshediscussionf environmentalssues.The scientific ommunityan helpalleviatehis earby making greater ffort oexplaino thepublicheuncertaintiesnvolvednestimatesf risk.Current tatutorymandates esignedo prolect ublichealth othdemandevelsof protectionhattechnologyannot chieve nd areuncoordinatedcross overnmentgencies.common tatutoryrameworkor dealingwilh environmentalisks s needed.naddition,aremustbe akeno separatehescientificrocess fassessingisk romtheuseof suchassessments,ogether itheconomcndpolicy onsiderations,nthe managementf risks hroughegulatoryction.

Science,Risk, and PublicPolicyWilliamD. Ruckelshaus

We are now n a troubledand emotion-al period fo r pollution control; manycommunitiesare gripped by something4pproaching anicand he publicdiscus-sion s dominated y personalitiesatherthan substance. t is not important toassignblame for this. I appreciatehat

confidence.The polls show that scien-tists have more credibility han lawyersor businessmen r politicians,and I amall three of those. I need the help ofscientists.This is not a naiveplea or science osave us from ourselves.Somehow.our

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More than 10yarsago, EPA had theClean Air Act, the CleanWater Act, asolid waste law, a pesticide aw, andlaws to control radiationand noise. Yetto come were the myriad of laws tocontrol oxic substancesrom their man-ufacture to their disposal-but that theywould be passedwasobviouseven hen.When I departedEPA a decadeago,the struggle over whether the federalgovernmentwas to havea major role inprotectingour health, safety,and envi-ronment wasended,The Americanpeo-ple had spoken. The laws had beenpassed; he regulationswere beingwfit-ten. The only remainingquestionwaswhether the statutory framework we hadcreated made senseor whether, overtime, we would adjust t.ScientificRealities

Ten years ago I thought I knew theanswer to that questionas well. I be-lieved it would becomeapparent o allthat we could virtually eliminate therisks we call pollution if we wanted tospend enoughmoney. When it also be-came apparent hat enoughmoney or allthepollutantswasa lot of money, cameto believe hat we would begin examin-ing the risks very carefullyand structurea system hat would force us to balanceour desife o eliminatepollution againstthe costsof its control.This would entailsomeadjustment f the laws, but not al lthat much,and t would happenby about1976. was wrong.This time around as administratorofEPA, I am determined o improve ourcountry'sability to cope with the risk ofpollutantsover where I left it 10 yearsago. t will not beeasy,becausewe mustnow deal with a classof pollutants orwhich it is difficult, f not impossible, oestablisha safe evel. These pollutantsinterferewith geneticprocesses nd areassociatedwith the diseaseswe fearmost: cancer and reproductive disor-ders, ncludingbirth defects.The scien-tific eonsensus s that any exposure,however small, to a geneticallyactivesubstance mbodies omerisk of an ef-fect. Since these substances re wide-spread n the environment,and sincewecan detect hemdown o very low levels,we mustassumehat ife now takesplacein a minefield of risks from hundreds,perhaps housands,of substances.Wecan no longer tell the public that theyhave an adequatemargin of safety.This worries al l of us, and it should.But when we examine he premisesonwhich suchestimates f risk are based,9 SEPTEMBER 1983

we find a confusing icture. n assessinga suspectedcarcinogen, or example,there are uncertaintiesat every pointwhere an assumptionmust be made: ncalculatingexposufe; in extrapolatingfrom high doSeswhere we have seenaneffect o the ow doses ypicalofenviron-mentalpollution; n what we may expectwhen humans are subjected o muchlower dosesof a substance hat, whengiven in high doses, caused umors inlaboratory animals and finally, in thevery mechanisms y which we supposethe diseaseo work.One thing we clearly need to do isensre hat our laws reflect hesescien-tific realities.The administratorof EPAshouldnot be forced o represent hat amargin of safety exists for a specificsubstance t a specific evelof exposurewhere none can be scientificallyestab-lished.This sparticularly rue where heinabiiity o so representorces he cessa-tion of all useof a substance ithout anvfurther evaluation.Functionsof RegulatoryAgencies

It is my strongbelief hat whereEPA,OSHA (the Occupational Safety andHealthAdministration),or any other so-cial regulatoryagency s charged withprotectingpublic health, safety, or theenvironment,we shouldbe given, o theextentpossible, commonstatutory or-mula fo r accomplishing ur tasks. Thisstatutory ormulamay well weighpublichealth very heavily, as the Americanpeoplecertainlydo.The formula shouldbe as preciseaspossibleand should ncludea responsi-bility for assessinghe risk and weighingit , not only against he benefits fcontin-ueduseofthe substance nderexamina-tion, but againsthe risksassociated ithsubstitute ubstancesnd he risksasso-ciatedwith the transferof the substancefrom one environmentalmedium o an-other through pollution control prac-tices. I recognize hat legislative hangein the crrentclimate s difficult. t is upto thoseof us who seekchange o makethe case or its advisability.But my purposehere s not to plead orstatutory change; t is to speakof riskassessmentnd isk management nd herole of sciencen both. It is important odistinguishhese wo essentialunctions,and I rely here on a recent NationalAcademyof Scienceseporton the man-agementof risk in the federal govern-ment.Scientists ssess risk to find outwhat the problemsare. The processofdecidingwhat to do about he problems

is risk management, he'secondproce-dure involves a much broader array ofdisciplines nd is aimed oward a deci-sion about control,In risk managementt is assumedhatwe have assessedhe health risks of asuspect hemical.We must hen actor nits benefits, the costs of the variousmethodsavailableor its control,and hestatutoryl framework for decision. TheNAS report recommendshat these wofunctions-risk assessmentand riskmanagement-besparated s much aspossiblewithin a regulatory gency.Thisis what we now do at EPA and t makessen e.Risk Assessment

We also need to strengthnour riskassessment apabilities.We need moreresearchon the health effects of thesubstanceswe regulate. intend to doeverything n my power to make clearthe importanceof this scientificanalysisat EPA. Given the necessity f acting nthe face of enormousscientificuncer-tainties, t is more important han everthat our scientificanalysisbe rigorousand the quality of our databe high. Wemust take great pains not to misleadpeopleabout he risks o their health.Wecan help to avoid confusionbe ensuringboth the quality of our scienceand theclarityof our languagen explaining az-ards.I intend to allocate some of EPA'sincreasedresources o pursuing theseends.Our 1984 equestcontainssignifi-cant increases or risk assessment ndassociated ork. We have equested 31million in supplementalappropriationsfor researchand development,and Iexpect hat risk assessment ill be morestrongly supportedas a result of thisincreaseas well.I would also ike to revitalizeour long-term research rogram o developa basefor more adequately rotecting he pub-lic health rom toxic pollutants. will beasking he outsidescientificcommunityfo r advice on how best to focus thosereSearch fforts.In the future, this beingan imperfectworld, the rigor and horoughnessf ourrisk analyseswill undoubtedlybe affect-ed by many actors, ncluding he toxici-ty ofthe substancesxamined,he popu-lationsexposed,he pressure fthe regu-latory timetable,and he resources vail-able. Despite these often conflictingpressures,isk assessmentt EpA mustbe basedonly on scientificevidenceandscientificconsensus.Nothingwill erode

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public confidenceaster than the suspi-cion that policy considefationshavebeenallowed o influence he assessmentof risk.Risk Management

Although here s an objectiveway toassessisk, there s, ofcourse,no purelyobjectiveway to manage t, nor can weignore he subjectiveperceptionof riskin the ultimatemariagementf a particu-lar substance. o do so wouldbe o placetoo muchciedence n our objectivedataand gnore he possibility hat occasion-ally one's ntuition s right.No amountofdata s a substituteor judgment.Further, we must search or ways todescribe isk in terms that the averagecitizencan comprehend. ellinga familythat ivesclose o a manufacturingacili-ty that no further controlson the plant's'emissions re needed ecause, ccordingto our linear model, their risk is onlvl0-6, is not very reassuring. e need describe he suspect ubstancess clear-ly as possible, tell people what theknownor suspected ealthproblemsare,andhelp hemcomparehat risk to thosewith which they are more familir.To effectively manage he risk, wemust seeknew ways o involve the pub-lic in the decision-making process.Whether we believe n participatoryde-moiracy or not, it is a part of or socialregulatory abric. Rather than praiseorlament t, we shouldseekmore magiha-tive ways to involve the various seg-mentsof the public fected by the sub-stanceat issue.They need to becomeinvolved early, and they need o be in-formed if their participation is to bemeaningful. We will be searching orways to makeour participatoryprocesswork better.For this to happen,scientistsmust bewilling to takea larger ole in expldiningthe risks to the public-including theuncertaintiesnherent n any risk assess-ment. Shouldering his burden is theresponsibilityof all scientists,not justthose with a particular policy end inmind. In fact, al l scientists houldmakeclear when they are Speakingas scieri-tists, ex cathedra,and when they arerecommending policy they believeshould flow from scientific information.

What we need to hear more of fromscientistbs science. am going o try toprovideavenues t EPA for Scientistsobecomemore nvolved n the public dia-log in which scientific problemsare de-scribed.Lest anyonemisunderstand, am notsuggestinghat all the elements f man-aging risk can be reduced to a neatmathematicl ormula. Going through adisciplined approach can help to orga-ni2e our thoughtsso that we includeal lthe elementshat shouldbe weighed.Wewill build up a setof precedentshat willbe useful for later decision-makingndwill provide more predictable utcomesfor any social regulatory prografiis weadopt.In a society n whieh democratic rin-ciples dominate, he perceptionsof thepublic must be weighed.,nsteadof ob-jective and subjective isks, the expertssometimes efer to "real" and "imagi-nary" iisks. There s acertainarrogancein this-an elitism hat has ll servedusin the past.Rather han decry the igno-rance of the public and seek o ignoretheir concerns,our goveinmentalpro-cessesmustaccommodatehe will of thepeopleand recognizets occasionalwis-dom..AsThomas efersonobserved,,I fwe think [the people] not enlightenedenough o exercise heir control with awholesome iscretion, he remedy s notto take it from them, but to inform theirdiscretion." ,Interagencyand InternationalCooidination

Up to thispoint I havebeensuggestinghow risks shouldbe assessednd man-aged n EPA. Much needs o be done ocoordinatehe variousEPA programsoensure a consistentapproach.I haveestablished task force with that char-ter.I further believewe shouldmakeuni-form the way in which we manage iskacross he federal regulatoryagncies.The public interest s not servedby twofederalagenciesaking diametricallyop-posedpositionson the healthrisks of atoxic substance nd hen arguing bout tin the press,We shouldbe able o coor-dinate our risk assessment roceduresacrossall federalagencies.The risk man-

agement strategiesthat flow from thatassessment ay ndeeddiffer,dependingon each agency's Statutory mandateorthe judgment of the ultimate decision-maker.But even at the management tagethere is no reasonwhy the approachescannot be coordinated o achievethegoal of risk avoidanceor minimizationwith the least societaldisruptionpossi-ble. havebeenexploringwith theWhiteHouse and the Office of Managementand Budget the possibilityof effectingbetter ntragovernmentaloordinatiori fthe way in which we assess ndmanagerisk.To push hisonqstep urther, believeit is in our nation'sbest nterest o shareour knowledge frisks andour approachto managinghem with the other devel-opednationsof the world. The environ-mentalmovementhas taughtus the in-terdependence f the world's ecbsys-tems. In copingwith the legitimatecon-cerns raised by environmentalists,wemust not forget that we cope in a worldwith interdependent conomies. f ourapproach to the managementof risk isnot sufficientlyn harmonywith thoseofthe other developednations,we Couldsaveour healthandrisk our economy.do not believewe need o abandonei -ther, bt to ensure hat it does not hap-pen, we need to work hard to sharescientificdata and understandhow toharmonizeour managementechniqueswith thseof our sisternations.In sum, my goal s a government-wideprocessor assessingndmanaging nvi-ronmental isks.Achieving his will takecooperationand goodwill within EpA,amongEXecutiveBranchagencies, ndbetweeriCongressand the Administra-tion, a stateof afairs that may partakeofthe miraculous.Still, it is worth trying,and the effort is worth the wholeheartedsupport of the scientificcommunity. Ibelieve such an ?ffort toucheson themaintenance f our current society, nwhicha democratic olity is grounded na high-technologyndustrialcivilization.Without a muchmoresuccessful ay ofhandling he risks associatedwith thecreationsof science, fear we will havesetup fo r ourselves grim and unneces-sary choice between the fruits of ad-vanced echnologyand the blessings fdemocracv.

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