Solution-Focused Risk Assessment: A Proposal for The Fusion of Environmental Analysis and Action

Adam ! Finkel" Sc!#! Fello$ and E%ecutive #irector Penn Pro&ram on Re&ulation 'niversity of Pennsylvania (a$ School

#RAFT) #ecem*er +,,.currently under&oin& peer revie$/

+ Abstract: Rethinkin& risk assessment as a method for helpin& to solve environmental pro*lems" rather than .merely/ understandin& environmental ha0ards" may provide three ma1or classes of *enefits over the status 2uo! First" it can help *reak the endless cycle of analysis: $hen the &oal is to kno$ enou&h to decide" rather than to kno$ everythin&" natural stoppin& points emer&e! Secondly" it can lead to more true decisions a*out ho$ to achieve risk reduction" rather than mere pronouncements a*out ho$ much risk reduction $ould *e optimal! As much as a&encies ri&htly value performance-oriented interventions" settin& a permissi*le e%posure limit or a national am*ient air 2uality standard is often more a conclusion a*out $hat level of risk $ould *e accepta*le than any kind of &uarantee that such a level $ill *e achieved" let alone a decision a*out $hich actual *ehaviors $ill chan&e and ho$! Third" it can promote e%pansive thou&ht a*out optimal decisions" ones that resolve multiple risks simultaneously" avoid needless and tra&ic riskrisk tradeoffs" and involve affected stakeholders in de*atin& $hat should *e done! Ar&ua*ly" the lon&er the disem*odied analysis of risk information is allo$ed to proceed *efore solutions are proposed and evaluated" the more likely it is that the pro*lem $ill *e defined in a $ay that constrains the free-$heelin& discussion of solutions" to the detriment of human health" the environment" and the economy! Therefore" 3 propose a ne$ solution-focused risk assessment paradi&m" in $hich the tentative arrayin& of control decisions $ould precede and &uide the assessment of e%posures" potencies" and risks! 4ey$ords: risk mana&ement" standard-settin&" decision theory" pu*lic involvement" technolo&y options

1. Introduction:
5e have steadily allo$ed the analysis of risks to health" safety" and the environment to drift apart6conceptually" *ureaucratically" functionally6from the actions $e take .or fail to take/ to reduce these risks! 3t is time" this am*itious proposal asserts" to repudiate *oth of the e%tremes6headstron& actions uninformed *y careful analysis" or endless analysis leadin& only to more understandin& rather than to any tan&i*le *enefits6in favor of a ne$ paradi&m" one in $hich scientific and economic kno$led&e is harnessed in service of identifyin& relia*le" creative" and e2uita*le solutions to health" safety" and environmental pro*lems! To assert that $e need to *alance the resources devoted to dissectin& pro*lems and the resources devoted to implementin& *eneficial policies may seem trite" *ut 3 $ill ar&ue that the steady rise of 2uantitative risk assessment .7RA/ and cost-*enefit analysis .89A/ : t$o developments 3 other$ise enthusiastically $elcome: has cro$ded out improvements in ho$ $e solve pro*lems" and has even *e&un to lull us into a false sense that $e are doin& anything to improve health and the environment! This $as not an inevita*le conse2uence of more ri&orous analysis" and it therefore can *e reversed $ithout compromisin& that ri&or *y one iota! 3n or&ani0ed attempts to protect pu*lic health and the environment" the relationship *et$een analysis and action is the interplay of risk assessment and risk mana&ement" and hence the interactions amon& risk assessors and decision-makers" $ho 1ockey *oth on *ehalf of their disciplines .science and economics" la$ and politics" respectively/ and as individuals seekin& influence! 3n addition to the amount of effort devoted to either assessment or mana&ement" ho$ever" the se2uencin& and content of the interactions is of paramount importance! This proposal seeks not only to focus relatively more attention on risk mana&ement .*y makin& risk assessment directly relevant to identifyin& sound decisions/" but to change the nature of the questions risk assessors are directed to answer. 3n a sense .see Section + *elo$/" this reverses the process first

C codified in the <-=; Red 9ook.</" in $hich assessors study pro*lems and mana&ers may then use this information to develop and choose amon& alternative control strate&ies" into one in $hich a tentative set of alternatives come first and the analyses e%plore ho$ these alternative decisions $ould impel chan&es in risk .and cost/!< This reversal $ould place risk assessors into the same common-sense relationship that e%perts and other purveyors of information have al$ays had $ith those $ho seek their counsel in everyday life! The mundane utterance that 3>ve &ot a pro*lem!!! is commonly an overture to !!! and 3 don>t kno$ $hat to do a*out it! ?nly in the psychiatrist>s office" and perhaps in the environmental" health" and safety re&ulatory a&encies" is it instead an overture to !!! and 3 don>t kno$ ho$ to think a*out it! As a risk assessor" 3 kno$ that the e%pertise my collea&ues *rin& can help decision-makers think" *ut as a citi0en" 3 $onder if instead that e%pertise should help them decide $hat to do! Someho$" our environmental protection apparatus has evolved to the point $here our *est minds are occupied helpin& society think a*out risks" not helpin& society reduce risks e%peditiously and efficiently! This proposal is *oth" and e2ually" aimed at improvin& risk mana&ement and risk assessment : *ut rather than addin& any ma1or ideas to the litany of admira*le technical improvements to risk assessment offered *y many others .+-@/" 3 aspire to increase the usefulness of the analyses and" perhaps selfishly" even to make the assessors> 1o*s more interestin&! We assessors can answer narrow, obscure, and deflating questions well, but we can also answer broad, momentous, even lofty questions well, if we are empowered
<

uch has *een $ritten .see especially the entire special issue in Au&ust +,,; of Human and Ecological Risk Assessment/ a*out $hether the current conception of the desired risk assessmentArisk mana&ement relationship actually ori&inated $ith the Red 9ook committee" or arose throu&h e%trapolation *eyond $hat the mis-read *ook actually said! Throu&h discussions $ith many of the ori&inal committee mem*ers .and throu&h service on the t$o BAS panels convened circa <--C and +,,D to re-e%amine these issues/" 3 have come to *elieve that the Red 9ook committee did not oppose the notion of a sym*iotic and iterative relationship *et$een risk mana&ers and risk assessors" so lon& as the functions $ere kept conceptually separate! Eo$ever" *y concentratin& on the landmark four-step process map for ho$ risk assessment could *est *e carried out : and *y omittin& any detail a*out $hat kinds of 2uestions assessors should *e pursuin& : the Red 9ook did contri*ute &reatly to the impression that risk assessment should hand off the *all to risk mana&ement" rather than vice versa! 3n any event" $hen 3 refer to the Red 9ook paradi&m" 3 intend this to mean ho$ the recommendations $ere &enerally heard" not necessarily $hat they authors may have meant!

@ or assert the power! to consider them! 5ith respect to improvin& risk mana&ement" 3 start from the vie$" firmly rooted in conse2uentialist ethics" that streams of harms .to health" safety" the environment" or to $ealth and economic &ro$th/ and *enefits .to the same/ constantly flo$ from our actions and from our failures to act! Therefore" every act $e fail to take that $ould increase *enefits net of harms+ : or every act $e take that fails to do as $ell on this score as a feasi*le alternative $ould : may *e a defeat! This proposal aspires not merely to help us declare more missions accomplished" *ut to accomplish them!

2. Summary of Proposal:
Solution-focused risk assessment .SFRA/" as 3 define it" must chan&e the timin& of $hen risk assessors consider risk mana&ement solutions" and may chan&e the nature of the solutions considered! 5ithout the mandatory process chan&e" there is no SFRA" *ut it is possi*le to re1ect the optional rethinkin& of the kinds of risk mana&ement options $e contemplate and still transform the paradi&m! Therefore" 3 $ill occaisionally refer to the more am*itious SFRA +!, $hen discussin& the pros and cons of chan&in& *oth the $hen and the $hat to a solution-focused approach! "he most basic definition of any form of #$RA is that it occurs when alternative risk management pathways are arrayed before detailed scientific analyses of e%posures, potencies and risks begin & in order that these analyses can focus on the risks and costs! of specific actions. Fi&ure < sho$s simplified process maps *oth for the current .traditional/ paradi&m and for SFRA! 3 ackno$led&e that various a&encies have added all manner of *ells and $histles to the <-=; Red 9ook dia&ram in $hich the four steps of risk assessment precede risk mana&ement" *ut Fi&ure < remains faithful to much of present-day decision-makin&! 3n particular" EPA has come to rely more and more of late on a dama&e function approach6$hich maps emissions to concentrations to e%posure to effects to *enefits! This" ho$ever" only adds detail to the same *asic lo&ic: risk
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9y this 3 do not necessarily mean the simple measure of Ftotal *enefit minus total costG" *ut prefera*ly estimates of social *enefit and cost that &ive special $ei&ht to individuals disproportionately harmed either *y the prevailin& risks or *y the costs of actions to reduce them!

D assessment culminates $hen it provides a $ay to convert chan&es in emissions .or concentrations/ to chan&es in *enefit! Beither in traditional nor solution-focused assessment should .or do/ detailed risk assessments sno$*all on their o$n a*sent a si&nal of harm .&enerally" adverse findin&s from one or more *ioassays or epidemiolo&ic investi&ations/! 3n either case" relia*le conclusions that there is no pro*lem : for e%ample" that human e%posures are none%istent or ne&li&i*le" andAor that the si&nal of harm $as a false positive : can and should end the e%ercise! Risk mana&ement is not a*out fine-tunin& solutions to trivial pro*lems" and nothin& a*out SFRA encoura&es such $asted effort! There may also *e situations in $hich the pro*lems are clearly non-trivial *ut no conceiva*le risk-reduction options e%ist .this may tend to occur" for e%ample" $ith naturally-occurrin& contaminants u*i2uitous in soil or other environmental media/) here too further efforts to analy0e $ould *e $asteful! Eo$ever" in all other kinds of cases6$here $e analy0e risks under the reasona*le e%pectation that there e%ist various optimal" sensi*le .*ut su*-optimal/" ineffectual" and perverse .net-risk-increasin&/ $ays to reduce them63 assert that there can *e enormous differences *et$een the outcomes of an assessment-first process and a solution-focused process! 8onsider the likely results of a traditional versus a solution-focused approach applied to the very *asic task of controllin& a particular su*stance present in am*ient or $orkplace air! At EPA" *oth the Bational Am*ient Air 7uality Standards .BAA7S/ process for criteria air pollutants and the residual risk process for to%icAcarcino&enic air pollutants; em*ody the assessment-first approach: risk assessors $ork to esta*lish an am*ient concentration that either .in the former case/ is re2uisite to protect the pu*lic health!!! allo$in& an ample mar&in of safety" or .in the latter case/ $ould assure that the individual most e%posed to emissions from a source Fof a &iven su*stanceG does not face a lifetime e%cess cancer risk &reater than <,-D! At ?SEA" risk assessors $ork to
;

3 $ill return to the to%ic air pollutants e%ample in Section C *elo$" as 3 reco&ni0e that 8on&ress in the 8lean Air Act Amendments of <--, also esta*lished a technolo&y-*ased process to precede the residual risk phase that EPA is no$ undertakin&!

H esta*lish an occupational e%posure concentration .the Permissi*le E%posure (imit" or PE(/ that comports $ith the <-=, Supreme 8ourt decision in the 'en(ene case .D/ .i!e!" does not reduce lifetime e%cess fatality risk *eyond the *oundary of insi&nificance" $hich the 8ourt helpfully said falls some$here *et$een <,-; and <,--/" althou&h here an assessment of economic and technolo&ical feasi*ility must accompany the risk assessment and is often the limitin& factor in constrainin& the PE(C .H/! These e%ercises can yield e%tremely precise results" a precision that is not necessarily false or overconfident! As lon& as risk assessors reali0e that any statement a*out the relationship *et$een concentration .or e%posure/ and risk can only *e properly interpreted as correct in three dimensions @" the BAA7S or the residual-risk concentration or the PE( can encapsulate all the scientific and economic .if applica*le/ information needed to serve its purpose of demarcatin& accepta*le risk .or a risk level that 1ustifies the costs of attainment/.=/! 9ut doin& the assessment is not at all the same as reducin& the risk! Sometimes $e pretend that the assessment sets the ta*le for the mana&ement of risk" $hen in fact $e do little or nothin& to turn $hat is per se nothin& more than a pronouncement : if the concentration of su*stance I in am*ient air falls *elo$ the BAA7S" the ample mar&in of safety $ill have *een provided" or if $orkers *reathe su*stance J at less than the PE(" their risk $ill *e accepta*ly small : into actions that can move us to" or closer to" the desired state of affairs! This &rim verdict is not merely a pessimistic appraisal of the va&aries of separatin& re&ulatory enforcement from &oal-settin&! 3 appreciate that .for e%ample/ 8on&ress intended the BAA7S process to *ifurcate" $ith a pronouncement a*out $hat concentration is desira*le at the national level totally separate from the su*se2uent approval of State 3mplementation Plans that specify ho$ each state $ill strive to attain
C

Bote that *ecause ?SEA &enerally sets one limit for a su*stance across all industries" there is no attempt to consider $hether the PE( re2uires *est availa*le technolo&y to achieve6only that in one or more su*sectors the PE( could *e no lo$er $ithout &oin& *eyond $hat is economically feasi*le! @ That is" the risk at a &iven e%posure is a particular estimator from a pro*a*ility distri*ution of uncertainty in risk" and it applies to a person at a particular point on a distri*ution of interindividual varia*ility!

= the desired concentration! 3 also appreciate that failure to enforce .$hich can involve insufficient efforts to find violators" inefficient tar&etin& of those inspection resources that are deployed" insufficient penalties to deter repeated or similar conduct" insufficient follo$-throu&h to verify a*atement" and other lapses/ is distinct from the failure to choose a sensi*le course of action! 3 simply o*serve that there are some fundamental" thou&h remedia*le" deficiencies $ith the very idea of settin& risk-*ased &oals: 5e may for&et to ever move *eyond articulatin& the &oal" to$ards furtherin& the &oalK 3 $orry that even the use of the term decision to announce the culmination of the limit-settin& step of processes like the BAA7S and PE(s .for e%ample" EPA .-/ e%plained in +,,= that the Administrator has decided to revised the level of the primary =-hour ?; standard to ,!,H@ ppm/ .emphasis added/ puts us on a slope to$ards *elievin& that intonin& a num*er is in any $ay tantamount to decidin& somethin&! )ost *risk+based, goals are in fact e%posure+based goals" $ith an implicit *ut perhaps &rossly fla$ed e2uation made *et$een e%posure reduction and risk reduction! Even if every esta*lishment that had a $orkplace concentration a*ove a ne$ ?SEA PE( immediately ended all e%cursions a*ove that concentration" $orker risk mi&ht rise rather than fall" if the compliance *ehavior entailed su*stitutin& a more to%ic su*stance for the re&ulated one! The &ro$in& literature on risk-risk trade-offs .<,-<C/ attests to the comple%ity of risk mana&ement and to the ease $ith $hich &ood intentions can produce unto$ard results!D ost fundamentally" the $ays $e ultimately mana&e risk $ill likely differ dependin& on $hether $e set the &oal first and su*se2uently think a*out the *est $ay.s/ to achieve it" or instead set our si&hts immediately upon tryin& to find the *est $ay.s/ to ma%imi0e net *enefit .or achieve accepta*le risk" or
D

3n a forthcomin& paper e%pandin& on an SRA presentation .<@/" 3 attempt to make the case that many of the most pu*lici0ed trade-offs $ere in fact either concocted *y the re&ulated industry to deter a&ency action .and $ere never plausi*le responses to the re&ulation/" or $ere more properly interpreted as $ake-up calls to find cost-effective $ays to control *oth the primary and the offsettin& risk! Bevertheless" 3 *elieve many le&itimate trade-offs do e%ist and should *e accounted for in policy!

any other endpoint dictated *y la$ or policy/! A ma-or aim of this article will be to argue that not only will a *solution focus, produce different results, but superior results to the traditional paradigm. For all three reasons : the traditional process can end $ith no risk-reduction actions at all" $ith actions that increase net risk" or actions that are less efficient than other$ise attaina*le : a decision process that thinks its $ay from solutions to pro*lems" rather than from pro*lems to solutions" may *e $ell $orth adoptin&! 8onsider t$o styli0ed e%amples of a solution-focused process" one from outside and one from inside the environmental" health" and safety realm: +!< A lonely +,-year-old colle&e student $ants to find a compati*le &irlfriend for a lon&-term relationship! Alon& each of several dimensions that vary &reatly amon& $omen his a&e .e!&!" physical *eauty" intelli&ence/" his preferences are for more rather than less6*ut he also *elieves that the odds he $ill *e a*le to strike up a conversation and ultimately sustain a relationship are less favora*le the more desira*le the potential companion is! Ee can certainly try to solve this riskA*enefit pro*lem *y estimatin& the point $here the properly-$ei&hted utility function crosses the pro*a*ility-of-success function) such an e%ercise $ould provide him $ith the &oal and an abstract &uide to $hat to do .don>t approach $omen su*stantially more or less desira*le than the *est estimate of the most desira*le person $ith $hom he stands a chance/! Ee could instead tackle the situation *y clearin& his mind of the a*stract ideal and focusin& on the attri*utes of $omen he actually kno$s and could approach! Althou&h the former process has the virtue of keepin& an infinite num*er of possi*le outcomes in play" the latter strate&y is of course much more practical" and 3 $ould ar&ue is ho$ $e intuitively approach personal decision pro*lems : *y evaluatin& choices" not *y dissectin& the pro*lem in a vacuum and then tryin& to map reality onto the a*stract conclusion! +!+ After <@ years of draftin& and redraftin&" a federal a&ency synthesi0es all the to%icolo&ic and epidemiolo&ic evidence a*out the cancer and non-cancer effects of +";"H"=-tetrachlorodi*en0o-p-dio%in .T8##/" and recommends an Accepta*le #aily

<, 3ntake .A#3/ in p&Ak&Aday! A Bational Academy of Sciences committee then rankorders various *road anthropo&enic sources of T8## .e!&!" coal com*ustion" pulp and paper effluent/ *y the fraction of total environmental loadin& they contri*ute" and various a&encies set priorities amon& the sources $ithin their purvie$! To&ether" their &oal is to steadily reduce entry of T8## into the environment until everyone>s uptake falls *elo$ the A#3! 9ut suppose instead that early into the scientific assessment phase" EPA and F#A colla*orated to e%amine the various products availa*le to filter coffee .similarly" to *re$ hot tea/ in residential and commercial use : the most common of $hich rely on chlorine-*leached paper and add trace amounts of T8## to the diets of tens of millions of Americans! ?ther means e%ist to *leach coffee filters $hite" un*leached paper filters or metal mesh filters could *e produced" and some methods do not rely on mechanical filtration at all! Each alternative has implications for the price" taste" and risk level of the finished *evera&e" and these factors can *e evaluated comparatively in a multi-attri*ute decision-makin& frame$ork) the results could drive policies ran&in& from information disclosure to ta% incentives to su*sidi0ed RL# to outri&ht *ans on products deemed needlessly risky! The steps taken $ould not solve the T8## pro*lem" *ut mi&ht solve the portion of it attri*uta*le to these particular sources! So $ith reference to Fi&ure <" the key step that makes a decision process solutionfocused is the second one" $hich is really the first step in the process $here risk assessment andAor risk mana&ement *e&ins! #$RA requires an initial brief moratorium on conducting free+form e%posure and dose+response assessment until the risk managers and assessors discuss the following sorts of questions. 5hat are the sources of this potential harmM Eo$ can the social purposes that the sources serve *e fulfilled $ith less risk to human health or the environmentM And ho$ can $e 2uantify the implications of each possi*le risk-reducin& intervention on risk" cost" e2uity" offsettin& risk" and any other factor $e should consider *efore choosin& $hether and ho$ to interveneM The same dose-response" e%posure" cost" and other information $ill likely *e needed to reach the decision point under *oth paradi&ms" *ut in the solution-focused process" that

<< information $ill help discriminate amon& feasi*le alternatives" rather than *e packa&ed first and only later re-opened in the .vainM/ hope that it $ill help &uide action! As 3 $ill emphasi0e later" the first key step of the alternative process is not pro*lem formulation" *ut solution formulation! 3 $ill ar&ue that $hile it is certainly smarter to think creatively a*out $hat the real pro*lem is .the sources of e%posure" not the su*stance per se/" the hi&hest use of risk-*ased decision-makin& is to mana&e opportunities" not simply to mana&e risks! The t$o e%amples a*ove also place into sharp relief the ma1or differences *et$een pro*lem-centered and solution-centered processes: The former sets up an e%pandin& $ork increases to e%haust the allotted time dynamic" $hereas the latter already starts from an e%pansive vie$ and narro$s the analysts> si&hts to conver&e upon a conclusion! 5hen the &oal is to understand the pro*lem" the finish line can recede faster than the movement to$ard it" $hereas $hen the &oal is to identify the *est availa*le solution" the analysis has a natural and hard-to-miss stoppin& point : $hen further analytic refinement $ould not chan&e the decision!H A series of solutions to components of a pro*lem can provide incremental *enefits" and perhaps can ameliorate the entire pro*lem" $ithout havin& to $ait for full understandin&! This is an especially dramatic contrast *et$een the t$o approaches $hen $e misconstrue the pro*lem as a sin&le issue $hen in fact is an a&&lomeration of issues .ar&ua*ly" $e don>t face a dio%in pro*lem" *ut a series of dio%in e%posures that each form part of an industrial policy pro*lem or an environmental desi&n pro*lem/! ost importantly" real choices are all a*out navi&atin& a sea of constraints and opportunities" and the t$o-step process .assessors opine a*out a desira*le a*stract &oal" leavin& mana&ers to pu00le out a $ay to achieve it
H

ore precisely" value of information theory .see Section @ *elo$/ specifies that $hen the cost .in resources andAor delay/ of o*tainin& additional information e%ceeds the e%pected reduction in the Fpro*a*ility times conse2uenceG of makin& a su*-optimal decision in the a*sence of that information" the additional analysis should not *e pursued!

<+ 6or to not achieve it/ neither e%ploits real opportunities nor is tethered to real constraints! This applies to environmental risk mana&ement in part *ecause $e can measure and model *oth risks and costs as continuous varia*les" *ut the real-$orld interventions $e mi&ht undertake tend over$helmin&ly to *e discrete and &ranular! 5e apply a mental model of pollution control .or food safety" or natural ha0ard mana&ement/ that posits a visi*le hand controllin& a dial to reduce e%posures until the remainin& risk reaches a level of accepta*ility or cost-effectiveness" *ut in reality there is no dial *ut rather a series of s$itches that provide only particulari0ed increments of e%posure reduction! 3t may *e interestin& to kno$ $here $e $ould cease turnin& the dial if $e had one" *ut our first priority should *e to assess the performance .*enefits conferred and costs associated/ of the s$itches $e actually could choose to flip" in order to decide $hich one.s/ to en&a&e! Bote that considerin& real solutions is not the same as the practice .common at ?SEA" and not uncommon at EPA/ of analy0in& multiple a*stract &oals" such as the desired e%posure concentration alon& $ith half and t$ice that concentration!= The optimal solution may turn out to *e closer to one of these permutations than it is to the initial pronouncement" *ut that $ill only occur *y coincidence" not *ecause &ettin& to t$ice the ori&inal proposed limit is a $ell-specified means to an end! Bone of this enthusiasm for analy0in& solutions rather than pro*lems $ill strike anyone trained in decision theory as novel : *ut perhaps that says somethin& a*out ho$ althou&h $e tend to think of risk assessment and decision theory as emer&in& from the same intellectual ferment" the t$o fields have drifted apart! The other important attri*ute of real decisions involves the interplay *et$een the timin& of $hen solutions are first raised and the *readth of solutions considered! 3n addition to the lack of &roundin& in opportunities and constraints" the other ma1or fla$ in
=

For e%ample" the +,,D BAA7S for fine particles proposed three decisions6the current *aseline" a ne$ limit of <@ N&Am;" and a stricter limit of <C N&Am; that EPA eventually re1ected! 3 hope it &oes $ithout sayin& that this is not evaluatin& solutions!

<; a pro*lem-centered approach is that as soon as the mind *e&ins to formulate in terms of a pro*lem" it closes the book on some solutions that can and will never even be considered, because they appear to fall outside the boundaries of acceptable deliberation. The ada&e that $hen all you have is a hammer" everythin& starts to look like a nail may *e more instructive $hen turned on its head: once you call $hat you>ve tripped over a nail" you immediately stop thinkin& a*out lookin& for any tool other than a hammer! The most *asic innovation of SFRA +!, is that it starts *y lookin& not at su*stances or ha0ards or risks as pro*lems" *ut as opportunities for change! Risks arise *ecause sources of risk e%ist" and ar&ua*ly the 1o* of the risk mana&er is to see thin&s that never $ere and ask O$hy not>M : to &o *ack to the source and ask ho$ chan&in& it can create a future $ith su*stantial and varied increases in net social *enefit! Therefore" the ne$ risk mana&ement paradi&m presented here challen&es decision-makers to take the first step6to envision possi*le interventions that mi&ht achieve an array of social &oals : and then to turn risk scientists and economists loose to amass information on the pros and cons of each possi*le intervention! The process does not stop there" and it contains many elements that $ill strike critics as familiar and uncontroversial" *ut this *asic insistence that .tentative/ solutions should precede conceptually the detailed dissection of pro*lems 2uestions the $isdom of much of the effort" time" e%pense" and accomplishments of risk assessors and mana&ers in the +@ years since the Red 9ook launched the era of risk-*ased &overnance!

3. Objections that Do ot Apply to this Proposal: 9efore discussin& .in Section H *elo$/ various thou&htful and so*erin& criticisms 3 have heard raised a*out these ideas" it may help to clarify several of the possi*le o*1ections that do not apply" *ecause they presuppose a vision for SFRA that 3 a&ree $ould *e un$orka*le or un$ise! There are enou&h o*stacles to creatin& a solution-first mindset" $here appropriate" $ithout addin& concerns *ased on a misperception of the concept:

<C #$RA is not intended to displace the traditional problem+centered approach, but to complement it in some settings and defer to it in others. There $ill al$ays the need for untethered risk assessments desi&ned to increase our understandin& of potencies" e%posures" and risks" and there $ill al$ays e%ist a&encies such as B3EES $hose missions do not include implementin& solutions .a&encies $hose names do not include $ords like protection and safety" su&&estin& a mission that ou&ht to &o *eyond pro*lem formulation/! Even in the re&ulatory a&encies" some activities are *etter suited to .or currently constrained *y statute to follo$/ pro*lem-focused thinkin&! And even if an a&ency em*races SFRA for a particular activity" thinkin& a*out solutions should occur in parallel $ith thinkin& a*out pro*lems: doin& the latter should help refine or e%pand the ran&e of solutions contemplated" and doin& the former should help refine the areas of uncertainty that need to *e resolved in the risk or cost analyses! 3 think it is a useful metaphor to consider the t$o approaches in terms of a &estalt dia&ram like the one in Fi&ure +: it takes mental discipline .especially if you>ve *een lookin& only at one part of the picture for too lon&/ to *e a*le to s$itch *et$een perspectives at $ill and reco&ni0e that the risks $e study are *oth pro*lems and opportunities! /dentifying an optimal solution does not imply that the risk manager should or can require anyone to implement the solution. any critics of &overnment re&ulation reserve special ire for rules that specify the means of compliance .althou&h as 3 $ill discuss *elo$" there is an element of strate&ic *ehavior in this o*1ection/! Eo$ever" &overnment certainly can determine $hich solution $ould ma%imi0e net *enefit and yet not have the authority to force its adoption" or choose not to e%ercise such authority! This $ould not at all make solution-focused analysis a $aste of effort" *ut mi&ht reflect a reasoned *elief that more &ood could *e done via a voluntary re&ime or throu&h market forces actin& $ith ne$ information on risks and costs! 9ut if merely discussing a preferred solution can *e attacked as coercive" then *oth SFRA and the

<@ traditional process $ill dra$ fire) *oth decision-makin& paradi&ms are intended for societies that have evolved *eyond anarchy! #$RA does not presuppose a single *right answer., The term optionsfocused mi&ht *e more palata*le as a $ay to convey that the mana&ement interventions are *ein& contrasted relative to each other rather than to some a*solute standard" *ut to many risk assessors" options implies modelin& options .defaults and model uncertainty/! There is admittedly some arro&ance even in strivin& for the relatively *est approach to a dilemma" *ut solution is meant here in the sense of many $ays to ameliorate a situation" not the conclusion that must supplant all others .as in the usa&e of that $ord in su*marine $arfare" $here the task is to plot a solution to &uide $eapons fire/! oreover" even the relatively *est idea at one point in time may need to *e reevaluated and refined" *oth durin& the analysis phase and after implementation! A $ell-desi&ned SFRA process should admit proposed solutions into the mi% durin& the analysis .informed *y an improved understandin& of risk/ and should look *ack to ensure that the intervention chosen is deliverin& the *enefits e%pected" and that ne$ $ays of doin& even *etter have not sprun& up in the meantime! #$RA only makes sense in situations where risks and0or costs matter. 3f a &iven decision must *e made *y random chance" *y an uninformed po$er stru&&le" or *y 8on&ressional earmark" then SFRA $ill *e a $aste of time6 *ut then so $ould any form of risk assessment! #$RA e%plicitly allows for *leaving well enough alone., The $ord solution is intended to encompass situations $here doin& nothin& is the *est alternative! Eo$ever" there is a $orld of difference *et$een doin& nothin& out of procrastination or denial" versus doin& nothin& *ecause any other alternative $as found to have smaller net *enefit or lar&er net cost! Regulatory agencies can and do! promote solutions other than regulatory ones. Emphasi0in& risk reduction over risk understandin& does not imply any

<D particular method of risk reduction : and if ta% incentives" or ri&ht-to-kno$ campai&ns" or voluntary pro&rams reco&ni0in& e%cellence" or the like make more sense than re&ulation" SFRA can and should *e a*le to accommodate this!

There are also some o*1ections to SFRA that $ould *e fatal to it" could they not *e anticipated and corrected! Foremost amon& these is the concern that puttin& decisions first in a se2uential process is tantamount to puttin& decision+makers in char&e of the analysis" $hich of course is the $ell-founded fear that drove the Red 9ook>s committee>s deli*erations +@ years a&o! There is no 2uestion that a corrupt SFRA process could yield corrupt results: it $ould *e farcical or $orse if risk mana&ers $ere allo$ed to instruct assessors to evaluate the pros and cons of options A" 9" and 8" *ut you had *etter make sure 8 comes out on top! 'ut there is nothing about asking the question this way that increases the risk of corruption over the current process, in $hich mana&ers could instruct .and certainly have instructed/ assessors to assess the risk of su*stance I" *ut you had *etter make sure to conclude the risk is trivial .or failin& that" at least to Olo$*all> it as much as possi*le/! The conceptual separation of analysis and mana&ement" and the safe&uards needed to keep mana&ers from pollutin& the analysis" are crucial $hether the mana&ers re2uest o*1ective information a*out risks or a*out risk-reduction alternatives! ?n the other hand" $hile mana&ers should keep a hands-off posture durin& the analysis itself" they should never have *een encoura&ed .as the Red 9ook or its misinterpretation may have done/ to a*sent themselves $hen the reasons for the analysis are articulated! Some may also o*1ect to puttin& the *rakes on risk assessment $hen uncertainty has *een reduced enou&h to confidently make a control decision! 3 respond that settlin& for less than e%haustive kno$led&e a*out risk in no $ay dum*s do$n the assessment! To the contrary" $hen the &oal is to kno$ enou&h a*out risk-reduction *enefits to choose $isely" it $ill no lon&er *e accepta*le to e%haustively pinpoint a non-risk measure such as the Rf# or the mar&in of e%posure6risk assessment $ill have to &ro$ smarter in order to e%press the science in metrics that relate to e%pected improvements in human health or

<H the environment .<D" 8hapter @/! 9ut it $ill *e important to make sure that assessors are not th$arted from continuin& to refine their understandin& of risk 1ust *ecause they may have reached a point in an immediate decision pro*lem $here they kno$ enou&h to present the results of a risk-*ased comparison of decision alternatives! !. "choes of S#$A in #amiliar Places: 3n the spirit of ackno$led&in& that SFRA *orro$s nearly all of its features from processes that others have already invented" and of tryin& to en&ender an 3>ve seen this *efore reaction amon& audiences $ho may *e comforta*le $ith solution-focused thinkin& in other settin&s" the follo$in& are some parallels that have stron&ly influenced my o$n thinkin&: 5ithin the risk mana&ement domain" SFRA can *e thou&ht of as assem*lin& to&ether the main thrusts of *oth lifecycle analysis .(8A/ and cumulative risk assessment .8RA/! SFRA merely e%tends (8A to social interventions that &overnment can re2uire or set in motion" as opposed to choices individual producers or consumers can make on their o$n) it applies 8RA to evaluatin& changes in risk .and cost/ rather than to improvin& our understandin& of the status 2uo of risk or cost! So" for e%ample" $hile (8A mi&ht compare the panoply of health and environmental effects of paper &rocery *a&s versus plastic ones .<H/" concern a*out a si&nal of harm from a su*stance found in plastic *a&s mi&ht spur an SFRA e%ercise that $ould evaluate various $ays to minimi0e e%posure to that su*stance" including policies that $ould discoura&e the use of plastic *a&s! 3n all of the comparisons" 8RA could improve the risk assessment *y considerin& incremental e%posure to the su*stance in terms of the concomitant e%posures to that su*stance from other sources .or e%posures to other su*stances *elieved to act via the same *iochemical path$ay.s/ to increase the risk of a particular health endpoint/! 'nlike the typical 8RA" ho$ever" SFRA $ould also e%plore the risk implications of policies that $ould increase the use of su*stitutes for plastic *a&s" and consider the incremental risks from those su*stances in terms of their o$n *aseline 8RA! To the e%tent that more and more e%perts in our field a&ree that i&norin& life-cycle impacts of a su*stance or product

<= is su*optimal" as is focusin& on mar&inal increments of e%posure $ithout considerin& the cumulative *urden" SFRA should comforta*ly fit alon& $ith those related ideas for increasin& the comple%ity and usefulness of risk assessments! Aficionados of the re&ulatory desi&n literature and o*servers of re&ulatory policies should also reco&ni0e SFRA as continuin& the lon&-standin& tu&-of-$ar *et$een performance-*ased standards versus desi&n- or technolo&y-*ased ones .$ith technolo&y here intended to cover the various means of effectin& risk reduction" includin& su*stitution" personal protective e2uipment" lifestyle chan&es" etc!" not necessarily end-of-pipe hard$are/! 'ut it is crucial to understanding #$RA to recogni(e that while it does view pure performance standards with suspicion, it also aspires to reform technology+based standards as they have come to be developed! To conclude as 3 have a*ove that a BAA7S or a PE( is not a true decision at all certainly displays a mistrust of performance standards e%pressed as sin&le-su*stance e%posure limits! 3ndustry has typically advocated for performance standards over desi&n standards" on the &rounds that central planners .implicitly or e%plicitly" they mean planners $ho likely have no first-hand kno$led&e of the industrial sectors they have po$er to re&ulate/ cannot possi*ly desi&n methods of compliance to achieve a &iven level of risk reduction at the lo$est cost" and should therefore satisfy themselves $ith settin& the *ar and lettin& companies reach the performance &oal in the efficient $ays only they can devise .<=-+,/! 9ut the most vociferous .and successful/ industry condemnation of a federal re&ulation in my e%perience $as directed at ?SEA>s er&onomics role in +,,<" and althou&h that rule had many procedural and su*stantive fla$s alon& $ith its many stren&ths" the lion>s share of opposition centered on its near absence of specific desi&n re2uirementsK- .+<"++/! Small *usiness" in particular" convincin&ly e%pressed dismay that ?SEA had set performance &oals $ithout providin& any *lueprint.s/ for ho$ companies
-

For a representative ar&ument alon& these lines" consider the floor statement of then-Senator Tim Eutchinson .R-AR/" ur&in& his collea&ues to vote to strike do$n the er&onomics re&ulation: The rule is replete $ith va&ue and su*1ective re2uirements $here employers must have an er&onomics plan in place to deal $ith such ha0ards! ?SEA said it is *ein& fle%i*le *y allo$in& employers to desi&n a plan that caters to their o$n $orkplace" *ut that same Ofle%i*ility> also re2uires the employer to *e an e%pert on er&onomic in1uries!

<could meet them! So the spectrum from the va&uest performance &oals to the most detailed specifications does not necessarily correspond to the ran&e from least to most intrusive and un$elcome to industry! 9y its very nature" SFRA develops and compares desi&n outcomes! 3n that sense" SFRA $ould definitely shift the *alance to$ard specifyin& the means of compliance! Eo$ever" 3 personally endorse the idea of craftin& hy*rid re&ulations $henever practical: the SFRA could identify the optimal desi&n" $hich $ould then have a risk reduction level .a performance &oal/ associated $ith it" and the rule could &ive the re&ulated parties the option of either follo$in& the specified desi&n .the safe har*or option/ or chan&in& products" processes" or uses to yield e2uivalent or &reater net risk reduction! 3 also recommend a different and even more important synthesis of performance and desi&n orientation" for $hich the 8lean Air Act Amendments of <--, provides an instructive motivation! ?ver the past ;@ years" 8on&ress has lurched *et$een re2uirin& EPA to impose performance-*ased and technolo&y-*ased standards for to%ic air pollutants! 5hen the initial risk-*ased re&ime only yielded seven emission standards in +, years" 8on&ress shifted &ears in the <--, Amendments to a technolo&y-*ased re&ime .the A8T standards/" *ut also foreshado$ed a su*se2uent risk-*ased round that EPA is no$ *e&innin& to put into place! 3n the first round after <--," EPA assessed the relative efficiency of different technolo&ies $ithout re&ard to ho$ much a*solute risk reduction they offered) so far in the openin& initiatives of the su*se2uent round" EPA has tended to set additional e%posure reduction &oals $ithout assessin& ho$ they $ill *e achieved .and at $hat cost and $ith $hat effects on other risks/! For e%ample" the +,,@ residual risk rule for coke ovens .+;/ emphasi0es a performance &oal to limit allo$a*le visi*le emissions to a small specified percenta&e of the time the units are operatin&! So the *est-availa*le-technolo&y e%ercise divorced from risk assessment is the ho$ $ithout the $hy" and .unless the stars ali&n fortuitously/ can result in too much technolo&y .the *est is very costly and reduces risk $ell *elo$ de minimus levels/ or in too little technolo&y .the *est at present is simply not &ood enou&h $hen vie$ed throu&h the lens of risk/! The other e%treme of a risk-*ased approach not &rounded in technolo&y results"

+, as 3 have ar&ued a*ove" in $hy $ithout the ho$ aspirational statements! What is missing here is the logical marriage of the risk+based and technology+based ways of thinking1namely" a risk+based technology options analysis .+C/! SFRA asks the re&ulatory a&ency to pro*e into the risk-reducin& capacity of various specific control options" and to produce a rule that ans$ers *oth the $hy and the ho$ .*ut a&ain" possi*ly allo$in& case-specific innovations that meet the risk &oal in different $ays than the safe har*or can/! 3f the *est availa*le technolo&y is simply insufficient to reduce risks to accepta*le levels" SFRA reveals this in one step rather than the 8lean Air Act model of a decade>s $orth of 9AT follo$ed eventually *y residual risk analysis! 3f a less e%pensive control is ample to eliminate or minimi0e risk" SFRA can stop here" avoidin& technolo&y overkill! 9ecause some of the pioneerin& advocates of technolo&y options analysis have e%pressed disdain or contempt for risk assessment .+@/" 3 hasten to emphasi0e that SFRA does not presuppose that a 0ero-risk control option is desira*le or even e%ists! This is not an idle o*servation" *ecause $hen vie$ed throu&h the .proper/ lens of cumulative risk" even a total *an on a su*stance or product mi&ht increase net risk despite its superficial appeal! 9ut the central para*le of ?>9rien>s *ook : that you should not *e advised to $ade across an icy river" even if the risks are trivial" $hen there is a foot*rid&e near*y : tells an important half of the story SFRA seeks to tell! Jes" look at the alternatives" *ut look throu&h the lens of risk assessment" not the lens of natural is *etter or any other do&ma! SFRA demands $e open our eyes to $inA$in options that some may hope $e i&nore" *ut it doesn>t e%pect to find .or to concoct/ such escapes $hen they are not truly availa*le! A re&ulatory paradi&m that harnesses risk assessment in the service of evaluatin& solutions challen&es the conventional $isdom in the same $ay that critics of risk-*ased priority-settin& have tried to focus planners> attention on allocatin& limited resources to specific actions rather than to disem*odied pro*lem areas! Soon after EPA em*arked upon risk-*ased priority-settin& $ith its 'nfinished 9usiness.+D/ and Reducin& Risk.+H/ reports" several scholars proposed $holly different $ays to set a *road environmental

+< a&enda that did not treat comparative risk rankin& as an end in itself .+=/! The advice that EPA could instead identify promisin& pollution prevention opportunities.+-/" or focus on localities $here residents faced multiple threats from overlappin& hot spots of pollution
.;,/

" or develop technolo&y-forcin& re&ulations for industrial sectors that had resisted

innovation a$ay from to%ic and ener&y-inefficient processes .;</" all derived from the *asic orientation that a&encies should see the task as ho$ to take the *est actions first" $hich is not at all the same as tacklin& the $orst risks first! Althou&h EPA has never undertaken a solution-rankin& initiative compara*le to its ma1or risk-rankin& e%ercises" '!S! e%perts have participated in &lo*al priority-settin& e%ercises or&ani0ed *y 91orn (om*or&" in $hich they ranked defined solutions to disparate environmental pro*lems that to&ether could *e achieved $ith an ar*itrary amount of e%penditure .;+";;/! The results of these e%ercises have sometimes *een misinterpreted to deni&rate the importance of pro*lems such as &lo*al climate chan&e" $hen in fact the rankin&s reflect a set of vie$s a*out the net *enefits of particular policy and other interventions" some of $hich effectively eliminate smaller pro*lems and others of $hich chip a$ay in cost-effective $ays at much lar&er pro*lems! (om*or& called some of his e%pert elicitations Rankin& the ?pportunities" $hich is e%actly the spirit of SFRA! The solution-focused alternative to traditional environmental decision-makin& may *e least surprisin& to practitioners trained in decision theory .;C-;H/" $hich at its core counsels individual and social actors to structure their thinkin& so as to compare alternatives .decision nodes/ in li&ht of information a*out pro*a*ilities and conse2uences .chance nodes follo$in& each possi*le decision" $hose conse2uences can *e assi&ned values alon& sin&le-or multi-attri*ute scales/!<,
<,

?ne of the modern pioneers in decision theory" Ralph 4eeney" ar&ues that the standard $ay of thinkin& a*out choices is *ack$ards" *ecause it encoura&es people to identify alternatives first *efore they articulate and reconcile their underlyin& values! 5hile SFRA mi&ht seem to push us further into this trap" 3 *elieve its emphasis on early *rainstormin& a*out solutions actually promotes the kind of value-focused thinkin& 4eeney advocates! 5hile traditional risk mana&ement rele&ates valuation .the conversion of conse2uences to commensura*le units of &ood and harm/ to the latter sta&es of the process" SFRA encoura&es decisionmakers to $iden the ran&e of solutions they accept as $orth evaluatin&" precisely *y encoura&in& them to think a*out values early and *roadly! 4eeney famously $rote that an une%pected phone call from a rival company offerin& you a 1o* does not create a should 3 stay or move to the rivalM pro*lem" *ut a $hat do 3 $ant to do $ith my careerM pro*lem6there are more than t$o options here! 3n the same $ay" 3 ar&ue that a $orrisome si&nal of harm does not reveal a ho$ much should $e reduce e%posure to Su*stance IM pro*lem" *ut a .ho$/ can $e fulfill the social purposes that products containin& I provide" at reduced riskM pro*lem : and of course *oth of the *roader 2uestions re2uire you to think creatively a*out future

++

SFRA also aspires to *e part of a tradition" datin& *ack at least as far as 9ernard Poldstein>s <--; essay".;=/ ur&in& less hand-$rin&in& a*out the uncertainties in risk assessment and more attention to decision-makin& as a craft $hose improvement $ould provide tan&i*le *enefits to society and also spur improvements in analysis! #isparate fields outside the area of environmental risk mana&ement also have traditions of encoura&in& solution-focused thinkin& to complement or supplant the pro*lem-focused mindset: 8linical medicine and pu*lic health have often emphasi0ed prevention over treatment $hen possi*le" and lookin& to alter root causes of disease rather than alleviatin& or maskin& symptoms! 5ith analo&y to the concentration of some pollutant in some environmental medium" the complaint to a physician that my pants are too ti&ht $ould pro*a*ly not elicit a measurement and a recommendation to *uy lar&er pants" *ut a discussion a*out opportunities for chan&e" perhaps includin& a comparative analysis of the pros and cons of dietAe%ercise versus liposuction versus diuretics! 3n psycholo&y" solution-focused therapy .SFT/ arose in the <-=,s as an alternative to the kind of counselin& that emphasi0es findin& roots in the patient>s past to e%plain his current pro*lem.s/ .;-/! 3nstead" SFT seeks to help the patient identify thin&s she $ishes $ould chan&e in her life and to nurture those aspects of her current life that are positive! ?ne techni2ue the therapist often uses to for&e connections *et$een &oals and concrete *ehavioral chan&e is the so-called miracle 2uestion" $hich typically asks the patient to ima&ine that he is a$akened one mornin& to find all his pro*lems solved as if *y a miracle! The key to this techni2ue is askin& the patient ho$ she $ould know that the miracle had happened) *y articulatin& the si&ns of miraculous chan&e" the patient may reco&ni0e concrete steps she can take to make some of those chan&es happen! SFT also tries to help patients recall small successes they have had that could *e replicated" and $hich sho$ that they don>t have to $ait
states of nature and ho$ you mi&ht value them!

+; passively for the miracle to occur! The parallels to environmental decisionmakin& should *e o*vious : thinkin& a*out a *etter future can point to$ards attaina*le $ays to &et there" and small improvements *e&et lar&er ones .$hereas $aitin& until the omni*us solution has *een pinpointed invites paralysis/! Amon& the various *usiness mana&ement and 2uality control theories that have sprun& up over the past half-century" one that ori&inated in the former Soviet 'nion points the $ay to a very different approach to environmental risk mana&ement" much as SFRA aspires to do! TR3Q" $hich is the acronym for the Russian Theory of 3nventive Pro*lem-Solvin& .Teoriya Resheniya Izobretatelskikh Zadatch/" is descri*ed *y its current populari0ers as a science of creativity that relies on the study of the patterns of pro*lems and solutions" not on the spontaneous and intuitive creativity of individuals or &roups! TR3Q emphasi0es lookin& for solutions have already *een applied to similar pro*lems" and adaptin& them to the current situation! 5ith particular resonance to the &ro$in& pro*lem of risk-risk trade-offs in environmental protection" TR3Q reco&ni0es that many pro*lems pose inherent conundrums .3 $ant to kno$ everythin& my teena&er is doin&" *ut 3 don>t $ant to kno$/" as do some conventional solutions .the product needs to *e stron&er" *ut should not $ei&h any more/! So TR3Q stresses the notion of the ideal final result as a $ay to open the mind to ne$ solutions that may sidestep the trade-offs entirely: the ideal final result seeks to fulfill the function" not to fine-tune the e%istin& means of minimi0in& e%ternalities! For e%ample" #om* .C,/ descri*es the la$nmo$er as a noisy" pollutin&" potentially unsafe" and maintenance-heavy solution to the pro*lem of unruly la$ns! Rather than continuin& to optimi0e the chosen means" she su&&ests one ideal final result mi&ht *e the development of smart &rass seed : &rass that is &enetically en&ineered to &ro$ only to the desired len&th!<<
<<

3 thank ichael 8allahan of EPA for callin& attention to this e%ample in an e%cellent presentation he made to the Bational Research 8ouncil>s #cience and 2ecisions committee in Fe*ruary +,,H!

+C

The ecolo&ical tradition also has currents $ithin it that emphasi0e movin& conceptually from solutions to pro*lems rather than e%clusively in the opposite direction! A&rarian 5endell 9erry calls this solvin& for pattern .C</: To define an a&ricultural pro*lem as if it $ere solely a pro*lem of a&riculture 6or solely a pro*lem of production or technolo&y or economics6is simply to misunderstand the pro*lem" either inadvertently or deli*eratelyR The $hole pro*lem must *e solved" not 1ust some handily identifia*le and simplifia*le aspect of it!

%. "&pected 'enefits of S#$A: A focus on solutions should yield some o*vious classes of *enefits" chief amon& them a portfolio of actions that are more timely and concerted than $hat $e have *ecome used to! 9ut an improved decision process actually offers more than the promise of *etter outcomes: 3.4. /t should give stakeholders opportunities to do what they most want and are best at doing : to contri*ute their special kno$led&e and preferences a*out decisions" rather than a*out science and risk! Recommendations from many 2uarters have emphasi0ed that *roadly inclusive decision processes are superior to narro$ ones" *ut have concentrated more on stakeholder access than on the content of their intended influence! And $hen content is discussed in the plannin& of pu*lic involvement" it sometimes tends to emphasi0e either special local kno$led&e of e%posure .e!&!" the possi*ility that &roups such as su*sistence fishers have uni2ue e%posures/ or special preferences in the a*stract .e!&!" su*&roups $ho mi&ht *e particularly concerned a*out cultural landmarks/! Ei&hli&htin& these sorts of issues in a pu*lic meetin& is certainly more likely to yield useful information" and less likely to frustrate the participants and smack of *ias" than the practice of invitin& pu*lic comment on arcane controversies around the underlyin& science" *ut more sensi*le still $ould *e the

+@ open discussion of the pros and cons of contrastin& solutions to the pro*lem at hand! Althou&h the particular solution that many of the participants $ere comin& to favor $as made moot *y other forces" one model for a solution-focused e%ercise in civic discovery.C+/ $as already pioneered at EPA" in the form of the Tacoma process championed *y administrator 5illiam Ruckelshaus in <-=C! 3n the future" EPA and other a&encies could also involve the affected pu*lic in the initial arrayin& of possi*le solutions" as $ell as the su*se2uent discussion of ho$ information on risks and costs distin&uishes the solutions from each other" $hich is $hat Ruckelshaus tried to do around the Asarco smelter in 5ashin&ton! The <--D Bational Academy of Sciences ?ran&e 9ook .C;/ emphasi0ed interactions amon& pu*lic officials" technical e%perts" and the populace to help reach a common understandin& of ho$ to descri*e a potential ha0ardous situation in as accurate" thorou&h" and decision-relevant a manner as possi*le .p! +/) SFRA simply su&&ests that rather than only tryin& to reach a common understandin& of the pro*lem" $e should *e makin& the decision relevant to the analysis and to the affected population! 3.5. /t will demand more complete and rigorous analyses, in three fundamental and long+overdue respects, &ivin& scientists and economists more license to incorporate information hitherto mar&inali0ed: movin& the endpoint from accepta*le levels of e%posure to *estperformin& decisions $ill hi&hli&ht the deficiencies of ar*itrary sin&le measures of e%posure" in favor of continuous relationships *et$een e%posure and conse2uence! The &ro$in& dissatisfaction some risk assessors" and many economists" stress a*out the Rf#ARf8 and the mar&in of e%posure metrics stems from concern that these measures do not relate to harm or *enefit : they merely demarcate a possi*le *ri&ht line separatin& desira*le from undesira*le" $ith no 2uantitative relationship *et$een the t$o! Sarious e%pert &roups .see" e!&!" 8hapter @ of Science and Decisions/ have recommended stron&ly that EPA and other a&encies develop parallel .or unified/ dose-response assessment processes for carcino&enic and noncarcino&enic ha0ards" in part so that decision makers and the pu*lic can

+D evaluate the *enefits of e%posure reductions that move some individuals from a*ove the Rf8 .or *elo$ an ?E of </ to the other side of those lines! ore importantly" the current approach leaves us po$erless to &au&e all those e%posure reductions that do not cross the line .i!e!" the *enefits of movin& from an e%posure $ell a*ove the Rf8 to an e%posure closer to *ut not *elo$ it" and of movin& from *elo$ the Rf8 to a level further still *elo$ it/! Any risk mana&ement process that relies on comparin& the *enefits of availa*le control options $ill drive demand for these more useful" and ar&ua*ly more scientifically appropriate" methods of assessin& to%icolo&ic potency! SFRA puts risk trade-offs front-and-center" forcin& decision makers to confront offsettin& risks *efore they create them" rather than havin& to *ackpedal after the fact! The contrast *et$een su*stance-focused risk assessment and SFRA is particularly stark $hen re&ulatin& the su*stance turns out to encoura&e su*stitution to a more to%ic material6a quintessentially perverse outcome to which the traditional 6E708AA9# process is oblivious! 3f" as 3 and others ar&ue is not infre2uently the case .<@" CC/" multiple interventions could readily reduce *oth the primary and the offsettin& risks" then surely it is far more sensi*le to analy0e these trade-offs up front and desi&n an optimal approach takin& net risk into account" rather than chasin& after ne$ risks created *y clumsy interventions! SFRA makes more visi*le $hat $e often consider covertly6the costs of control! Even $hen a&encies are for*idden from makin& the costs of control a determinin& factor in decision-makin&" it is clear that the solution set simply e%cludes options that $ould *reak the prover*ial *ank.C@/! To lo&ically compare those options that remain" SFRA $ill demand more ri&or in ho$ $e estimate costs" there*y helpin& fi% the $eakest link in all of 2uantitative environmental analysis! #efined actions to reduce risks have costs" as do promises that risk-*ased &oals $ill *e met throu&h some undetermined future actions : *ut it is much easier to &au&e $hether the actions $ill yield risk reductions $orth their cost if they are chosen throu&h the kind of process of

+H comparin& alternatives that SFRA impels! 3nattention to cost can lead either to over-re&ulation or to under-re&ulation" $ith the latter occurrin& *oth acrossthe-*oard .throu&h the $ell-documented tendency to e%a&&erate costs/ and in important aspects of re&ulatory scope .$here tacit consideration of costs results in e%emptions" variances" and la% treatment for sectors of industry that sometimes impose hi&h risks $hose reductions $ould *e costly to them/! 3n an on&oin& series of pro1ects" collea&ues and 3 are documentin& the lack of attention in re&ulatory analysis to uncertainty and interindividual varia*ility .in the sense of the share of total cost *orne *y individuals and su*populations of consumers and producers/ in cost" especially as compared to the increasin& ri&or $ith $hich risk scientists no$ routinely estimate uncertainty and varia*ility in risk.CD"CH/! Even if SFRA does not add *ack into the solution set various options e%cluded *efore their lar&e costs $ere ever compared to their hu&e *enefits" the act of startin& the cost estimation process earlier should improve it" to the e%tent that the lack of ri&or is due to the <<th hour nature of this activity at present! @!; /t structures the decision+making process to embrace uncertainty and make the best of it. SFRA can *reak the vicious circle of mishandlin& uncertainty leadin& to poor decisions" and help us confront uncertainty as the ally it should *e to effective policy rather than its adversary! For the important special case $hen model uncertainty makes it impossi*le to kno$ $hich of t$o or more dramatically different estimates of risk is correct" there are lo&ically only three *asic $ays to proceed: .</ put the model uncertainty to the side" &ivin& one default model at each inference point primacy over all alternatives" until an alternative *ecomes compellin& enou&h to supplant the default) .+/ construct a hy*rid risk estimate .or hy*rid uncertainty distri*ution/ *y avera&in& to&ether the various point estimates or distri*utions" $ei&hted *y the de&ree of *elief assi&ned to each: or .;/ do it the $ay decision theory instructs6namely" assess the pros and cons of different decisions, in full light of the multiple possible risk estimates. 9ecause the second option is so $ron&-headed compared to the third" 3 have favored the first option" assumin& that EPA could someho$ finally develop a common-sense and transparent system for evaluatin& default assumptions versus alternative ones out of the

+= current morass of confusion it has created around this issue.<D" 8hapter D" esp! footnote +/! 9ut risk estimates that place 0ero $ei&ht on all inferences other than the default are *y definition overconfident" and SFRA simply handles model uncertainty correctly rather than incorrectly! 5hen the risk is either of ma&nitude A .$ith pro*a*ility p/ or 9 .$ith pro*a*ility .<-p//" it is simply incorrect for the risk assessor to cause the decision maker to act as if the risk $as kno$n $ith certainty to e2ual FpAT.<-p/9G" *ut this is e%actly $hat most proposals for model avera&in& do .C="C-/! 5ith reference to the hurricane para*le 3 developed durin& the re&ulatory reform years.@,/" the Red 9ook process .assessors do their $ork shielded from kno$led&e of the alternative solutions/ $ould tempt participants into discussin& .non-e%istent/ landfall sites *et$een Be$ ?rleans and Tampa" and perhaps to construe the decision pro*lem as ho$ *est to $arn or evacuate o*ileM 3nstead" they need only ask this simple 2uestion rather than that fatuous one: if the risk is either A or 9" ho$ does solution I perform a&ainst a risk of si0e A or si0e 9" as compared to ho$ solution J $ould performM To turn the para*le into a real analo&y" consider a risk that is either hu&e .under the default assumption/ or 0ero .under a plausi*le alternative assumption/! The risk-first process misleads the decision maker into thinkin& a*out the accepta*le e%posure to a risk of si0e p times hu&e" $hereas SFRA asks $hether i&norin& a hu&e risk .$ith pro*a*ility p of makin& that mistake/ is *etter or $orse than the cost of eliminatin& a non-e%istent risk .$ith pro*a*ility .<-p/ of errin& in that $ay/! Sure" it mi&ht sometimes *e *est of all to reduce the risk *y a factor of .<Ap/ .evacuatin& o*ile/" *ecause that action has a smaller e%pected loss than either of the t$o strate&ies that mi&ht actually *e correct" *ut that kind of compromise should arise out of a thou&htful $ei&hin& of conse2uences rather than as the inevita*le result of a process &uaranteed to mislead! SFRA also may *e the only $ay to correctly open the door to an enormously useful cate&ory of real decisions : those in $hich gathering more information emer&es as prefera*le to decidin& no$! 5hile there are $ays to think a*out the value of information other than *y formal S?3 methods .@<"@+/" those methods do a*solutely re2uire that the decision options *e specified! 3ndeed" the cru% of S?3 theory is that information has value only insofar as armed $ith it" one can reduce the pro*a*ility or conse2uence of choosin& a decision that is inferior to another availa*le choice! This is very different

+from puttin& research money into interestin& 2uestions" or into the lar&est uncertainties" $hich is the thou&ht process that often passes for systematic these days! S?3 theory insists that seekin& information that could potentially chan&e the rank orderin& of solutions is the most valua*le6indeed" the only valua*le6$ay of spendin& one>s time short of decidin&! And of course" one can>t even *e&in to think a*out ho$ much money and time should *e spent on research rather than on control" and $hich research pro1ects mi&ht *e the most valua*le" unless one is $illin& to moneti0e *y ho$ much the choice amon& solutions suffers due to the e%istin& uncertainty!

6. Advances in Decision-Making Processes that Do Not Constitute SFRA. Althou&h o*servers have raised various serious concerns a*out the $isdom of SFRA .see Section H *elo$/" it may actually face more o*stacles to ever *ein& tried out from assertions that is already *ein& done or that it has already *een proposed else$here! Several recent sets of recommendations for chan&in& risk-*ased decision-makin& are creative" visionary" and responsi*le for openin& doors to solution-focused ideas : and each may $ell *e superior to SFRA in some or all respects : *ut they do not propose SFRA as 3 descri*e it here" and some cases may in fact *e its antithesis: The <--D Bational Academy of Sciences ?ran&e 9ook.C;/ e%panded upon the Red 9ook paradi&m that risk assessment should remain conceptually separate from risk mana&ement" *y redefinin& risk assessment as a decisionrelevant e%ercise! 3n the conte%t of the entire report" 3 *elieve this 8ommittee meant decision-relevant in the sense of the importance and scope of the decision should determine .respectively/ the level of resources and ri&or the correspondin& risk assessment should have" and the array of stakeholders $ho should *e *rou&ht into the process! 5hile this is dou*tless true" it is not tantamount to recommendin& that decision options *e arrayed *efore risk assessment *e&ins in earnest" as 3 am proposin& here! There are many connotations of the statement" made in the ?ran&e 9ook and in many other influential documents" that risk assessment should serve the needs of

;, decision makers) SFRA asserts that $hat need they most of all are assessments that compare the risks and costs of different decisions" $hereas these and other reports seem to leave it up to decision makers to determine their o$n needs! Soon thereafter" the PresidentialA8on&ressional 8ommission on Risk Assessment and Risk Eealth Risk ana&ement .P88RA / released its t$o-volume report.@;/" a centerpiece of $hich $as its Frame$ork for Environmental ana&ement! This frame$ork sou&ht to &reatly improve the usefulness and relevance of risk assessment *y emphasi0in& the need to consider multiple sources of e%posure" multimedia transfers" risk-risk tradeoffs" and cumulative e%posures to ha0ards affectin& common *iolo&ical path$ays" and it did carve out a place in its si%-phase he%a&on for the risk*ased evaluation of decision options! All these advances reflected cuttin&ed&e thinkin&" *ut the 8ommission clearly did not envision anythin& like SFRA! 3ndeed" the Frame$ork takes pains to mention .p! <</ that it is very important to consider the full conte%t of the pro*lem *efore proceedin& $ith the other sta&es of the risk mana&ement process! The se2uence is clear: the $ork of e%aminin& options does not have to $ait until the risk assessment is completed .emphasis added/ .$hereas SFRA>s foundation is doin& so *efore the risk assessment really *e&ins/" and only in some cases may e%aminin& the options help refine a risk analysis .p! +;/! 3f 3 am correct that the very act of definin& the pro*lem can foreclose consideration of some options" then not identifyin& the solutions until the third of si% steps in the P88RA frame$ork saps the solution focus entirely! 3 also infer a very different am*ition than mine in P88RA >s emphasis on puttin& risks in conte%t! SFRA ur&es decision makers and the pu*lic to look for opportunities to broaden their si&hts and reduce multiple risks! The recurrin& e%ample in the e%planation of the Frame$ork" in contrast" is that of a refinery that e%poses near*y residents to to%ic air pollutants) every additional reference in the e%ample to other sources of the same or different

;< to%icants reinforces and leads up to the su&&estion .p! <;/ that if the residual leukemia risk from refinery emissions!!! proves insi&nificant Fcompared to the leukemia risk from other sourcesG" risk reduction mi&ht *etter *e directed at other sources! SFRA $ould never insist that the optimal solution must necessarily involve a reduction in refinery emissions" *ut neither $ould it pre1ud&e that such a solution couldn:t be optimal simply *ecause the affected population also faced other voluntary or involuntary risks! A +,,@ BAS report.@C/ to the '!S! #epartment of Ener&y .#?E/ did put for$ard a decision-makin& frame$ork that contains many of the elements of SFRA: A coherent and efficient risk assessment re2uires R that a sufficient num*er of options from $hich to choose *e considered in the decision to avoid e%cludin& potentially superior options! Therefore" the first step is that a decision *e defined) and second that a list of decision alternatives from $hich to choose *e considered! 9ut this committee" 3 assume" did not intend to propose a &eneral frame$ork" *ut one specific to the structured *inary choice facin& #?E of $hether or not to e%empt a particular kind of $aste from a default re2uirement that the $aste *e stored permanently in a deep &eolo&ic repository! 5hen the decision options are this cut-and-dried" a comparative risk assessment seems the natural $ay to proceed" althou&h this BAS committee certainly made a compellin& case for a solution-focused mindset! ost recently" the +,,- BAS study on Science and #ecisions devoted su*stantial effort to proposin& a ne$ Frame$ork for Risk-9ased #ecisionakin& that endorses some of the principles of SFRA as discussed in this article!<+ ?n one hand" the +,,- Frame$ork e%plicitly contrasts the traditional approach $ith one that asks $hat options are there to reduce the
<+

3 $as a mem*er of this BAS 8ommittee" and advocated in that forum for essentially all of the concepts descri*ed in this article : so the differences reflect the reasoned o*1ections of many distin&uished scholars of risk assessment and policy! Elements in this article>s version of SFRA not contained in Science and Decisions pro*a*ly should *e interpreted as the 8ommittee havin& found them undesira*le or poorlye%plained! 3n particular" at least one of the other 8ommittee mem*ers e%plained in the trade press .@@/ that $e $ere Overy careful> to $rite the section on increasin& utility in risk assessment such that it did not recommend *e&innin& risk assessment $ith solutions6$hich is e%actly $hat SFRA does recommend .assumin& that the reporter>s 2uote should have read *e&innin& risk mana&ement $ith solutions/!

;+ ha0ards or e%posures that have *een identifiedM *efore the risk assessment *e&ins .p! +C+/" and it concludes that risk assessment is of little usefulnessR if it is not oriented to help discriminate amon& risk-mana&ement options! This represents a &iant step to$ards insistin& that solutions need to *e arrayed early in the process" and the report reinforces this $ith an up*eat tone a*out the increased importance of risk assessment in the ne$ paradi&m and a*out the readiness of risk assessors to deliver on the raiseFdG e%pectations for $hat risk assessments can provide! 9ut on the other hand" the key Fi&ure descri*in& the Frame$ork .Fi&! =-< in the report/ does not fully track this narrative description" in that the activities prior to the risk assessment phase are called pro*lem formulation and scopin&" and start $ith the 2uestion $hat pro*lems are associated $ith e%istin& environmental conditionsM *efore movin& on to considerin& options to address these pro*lems! To the e%tent that this initial phase is meant to endorse and su*sume the concepts of Pro*lem Formulation .PF/ and Plannin& and Scopin& .PLS/ in EPA>s Puidelines for Ecolo&ical Risk Assessment" Air To%ics (i*rary" and else$here" the Frame$ork ends up *ein& decision-driven .as in the ?ran&e 9ook <; years prior/ *ut not truly solution-focused! PLS makes the important advance of &roundin& the si0e and ri&or of the technical analysis to meet the demands of the particular decision for timeliness and fidelity to statutory dictates" and of focusin& it on 2uestions $ithin the *oundaries of the pro*lem .neither strayin& outside the *oundary nor leavin& important issues unaddressed/! A properly-planned risk assessment $ill surely *e more useful and cost-efficient than a free-form fill up your *lue *ook until $e say your time is up analysis" *ut it may never analy(e the benefits and costs of any particular solution, and will likely fail to contemplate certain solutions altogether. (ike$ise" PF aims to shape the risk assessment so as to shed li&ht on specific effects on defined populations or receptors6sharpenin& the analysis to clarify the real pro*lem in all its facets rather than the pieces of it that lie in the li&ht of the prover*ial lamppost6*ut this too is not the same as SFRA! 3n the case of PF" the name really &ives it a$ay) thinkin& hard

;; a*out the pro*lem is valua*le" *ut it is actually the opposite of seein& the situation as an opportunity to e%plore solutions! The 8ommittee>s description .p! +CH/ of Phase 3 reveals ho$ the ne$ Frame$ork stops far short of endorsin& SFRA! The &oal of Phase 3 is clearly to shape the risk assessment to the pro*lem" *ecause in the e%ample used of premarket approval of ne$ pesticides" there are $ell-esta*lished &uidelines for risk assessmentsR F$hich alreadyG constitute Phase 3 plannin& in this type of decision! 3n other $ords" if you kno$ $hat analysis is needed to provide the decision-maker $ith ample information of the type s0he believes is needed, the pro*lem is properly formulated and the assessment properly scoped! 'ut that is e%actly the mold #$RA seeks to break. Even a narro$ solution formulation e%ercise $ould look *eyond the simple yesAno 2uestion of $hether or not the ne$ pesticide is safe and effective for specific crops .and further *eyond the 2uantitative e%ercise of settin& an accepta*le application rate or field re-entry interval/" and $ould consider supplementin& the $ellesta*lished &uidelines to consider different accepta*le e%posures dependin& on cumulative and a&&re&ate risk and other factors! To truly open the door to opportunities $ould further re2uire all participants to consider the decision the $ay 4eeney ur&es $e think of the prover*ial une%pected 1o* offer: not should $e add one more pesticide to the arsenalM" *ut ho$ can $e encoura&e the safer and more efficient production of the foodstuffs this pesticide mi&ht *e used onM That is a different decision than the one EPA normally contemplates" $hich is precisely the point and precisely the door the Science and Decisions report apparently did not $ish to open!<;

7. Serious Concerns, and Partial Counter-Argu ents.

<;

3nterestin&ly" another unit of the Bational Research 8ouncil has reportedly *e&un to plan a ne$ study" A Frame$ork for Alternatives Assessment to 3nform Povernment and 9usiness #ecisions 8oncernin& Safer 8hemical Policies and Practices" that may consider marryin& (8A and comparative risk assessment in an alternative assessment process that may look very much like SFRA6so it is possi*le that Science and Decisions may represent the needed partial step to$ards SFRA that paves the $ay for a real evaluation *y the BR8 of $hether it has promise!

;C The steps that Science and Decisions made to$ards earlier consideration of risk mana&ement options have already aroused criticism.@@/" and the more e%pansive concepts of SFRA have prompted these and other o*1ections in several pu*lic forums over the past year! 3 offer here a partial catalo& of the more portentous concerns that have *een raised" includin& some others that $ere raised durin& the Science and Decisions 8ommittee>s deli*erations" alon& $ith the *e&innin&s of some attempts at re*uttal and synthesis! The *reath and intensity of these concerns has convinced me that SFRA should not *e implemented on other than a demonstration *asis $ithout much more discussion of its possi*le fla$s" *ut also that pilot pro1ects are $ell $orth undertakin& in order to see $hich of these o*1ections are truly clear-headed! H!< #$RA will e%acerbate the e%isting *inappropriate over+involvement on the part of political risk managers, .Peter Preuss" 2uoted in .@@//, perhaps leading to the kind of corruption the Red 'ook committee worked so hard to identify and minimi(e. As 3 discussed a*ove" 3 a&ree that this could *e a fatal fla$ of SFRA" *ut 3 do not a&ree that a discussion of solutions could *e hi1acked any more readily than could any discussion of ha0ards and risks! ?ne also needs to $ei&h *oth $orst-cases : the effectin& of risk mana&ement decisions that reflect the political $ill of elected or appointed officials" a&ainst the other e%treme" $hich $ould *e the .eventual/ completion of pristine assessments that may lead to no risk reduction activities at all! H!+ Agencies are forbidden by statute from analy(ing the risks and costs! of defined options, but must study risks in isolation before contemplating solutions. The universe of situations $here an a&ency does not conduct a particular analysis is much *roader than situations $here la$s or court decisions actually have for*idden it from doin& so.C@/" and in still other cases" the a&ency does not pu*lish the analysis *ut nevertheless conducts one for internal use or to satisfy the ?ffice of 3nformation and Re&ulatory Affairs! Even $here an a&ency is re2uired to produce a free-form risk estimate" as in the BAA7S process" it could still do so after thinkin& e%pansively a*out solutions" in effect conductin& *oth a solution-focused e%ercise and a &eneric .risk per unit e%posure/ analysis in parallel" and shuntin& the former into a pu*lic-information e%ercise! 'ltimately" some statutes may need to *e amended for SFRA to make ma1or inroads" *ut

;@ some of us see that as a *rid&e that may need to *e *uilt for other reasons".@D/ not as a chasm that must necessarily remain uncrossed! H!; 'ecause *he who controls the options controls the outcome,, #$RA further! skews the power structure away from the affected citi(ens and their public+interest guardians, and towards the regulated industries. This criticism has si&nificant merit" as some of the crucial information a*out solutions .their very e%istence" as $ell as their costs and efficacies/ may *e closely held *y the re&ulated community" and in1ected into the process strate&ically .and perhaps not in a verifia*le $ay/! Some of the same concerns have al$ays applied to risk information" *ut in theory independent replication of to%icolo&y testin& or e%posure monitorin& could *e undertaken! 3n the spirit of a $inA$in response" a sensi*le reaction to this pro*lem mi&ht *e for the a&encies to su*sidi0e participation in solution-&eneratin& e%ercises *y representatives of the pu*lic! 3 also note that some of the une2ual distri*ution of po$er ar&ument is reminiscent of similar concerns environmental &roups have raised a*out risk assessment itself" and that it is possi*le some of this asymmetry is deli*erate and self-fulfillin& on their part.@H"@=/! H!C "he e%plicit choice of a solution and the re-ection of others! in a regulatory proceeding is fodder for litigation challenging the decision. Eere the .more/ perfect is the enemy of the &ood" assumin& reasona*ly than a va&ue performance-oriented standard that survives 1udicial and 8on&ressional challen&e is *etter than nothin&! ?n *alance in my e%perience" the risk-aversion of a&ency la$yers has stymied sensi*le attempts to make re&ulations more strin&ent" participatory" and transparent" *ut despite a &eneral tendency to$ards 1udicial deference" the la$yers> 1o* does remain that of reducin& the risk of endin& up $ith no standard at all! The same sorts of o*1ections" thou&h" have *een raised a*out the efforts *y risk analysts to *e more honest a*out uncertainty" and courts increasin&ly no$ seem to appreciate that ackno$led&in& uncertainty is not a si&n of $eakness in the analysis6so sho$in& more of the lo&ic *ehind a choice amon& solutions may create a virtuous circle that increases 1udicial and pu*lic tolerance for am*i&uity and for optimi0ation in the face of it! H!@ #$RA makes risk assessment harder to do. Former EPA Assistant Administrator Peor&e Pray made this point at the SRA annual meetin& session on SFRA in #ecem*er

;D +,,=.@@/" su&&estin& that once decisions are compared" deficiencies in ho$ uncertainty .especially model uncertainty/ is 2uantified *ecome more apparent and more de*ilitatin&! 3 a&ree" *ut see this as a stren&th of SFRA" *oth per se and for ho$ it mi&ht help lessen the lon&-standin& mismatch *et$een the enormous financial and human stakes of makin& sound risk mana&ement decisions relative to the mea&er resources $e devote to conductin& and improvin& analysis.@-/! H!D Assessments performed for an #$RA may be useless for other purposes, leading to widespread and wasteful duplication of efforts. Accordin& to risk reporter Steve Pi**.D,/" $hen risk assessments are tailored to specific pro*lem sets and circumstances" the immediate decision may *e served e%tremely $ell" *ut there may *e a tradeoff that erodes the common applications of these types of assessments else$here! 3 a&ree" and ur&e that the science a&encies .B3EES" B3?SE" etc!/ *e e%panded to provide more ra$ materials .dose-response assessments for su*stances and mi%tures" e%posure assessments for industrial processes and products/ that can *e adapted to 1ump-start solution-focused assessments the re&ulatory a&encies $ill undertake! #uplicate risk assessments are already a &ro$in& pro*lem in the current environment" of course" in $hich disparate a&encies .and even pro&rams $ithin a sin&le a&ency/ seem reluctant to take advanta&e of $ork performed else$here! H!H /t makes no sense to array any solutions before you know what the problem is. 9ecause 3 *elieve the *alance is currently tipped so much in favor of dissectin& pro*lems and considerin& solutions too late in the &ame or not at all" 3 have emphasi0ed the inverse of this process! 3 do not a&ree that it is nonsensical to *e&in *y mappin& the si&nal of harm *ack onto the products and process from $hich it emer&es" and considerin& tentative $ays to improve these processes in risk-reducin& $ays! 9ut the initial step .after you have thou&ht carefully a*out $hat the si&nal of harm represents/ of e%pansive thinkin& a*out solutions should promptly return to re-&roundin& the endeavor in traditional pro*lem-focused thinkin&6and thence to a recursive process in $hich more information a*out risk refines the solution set" and more information a*out solutions directs the analysis to$ards specific kno$led&e &aps and uncertainties! 3f either strain of thinkin& proceeds for too lon& $ithout the other" the process $ill suffer" *ut $hile too

;H much thinkin& a*out solutions may turn into idle daydreamin&" too much fi%ation on pro*lems" 3 $arn" may foreclose opportunities to desi&n the interventions that $ill in fact yield the &reatest net *enefit" a more unfortunate outcome! H!= #pecifying the means of compliance free(es technology, leading to less risk reduction in the long run. 3n theory" this dra$*ack of SFRA concerns me more any of the others mentioned so far) the literature contains many criticisms of technolo&y-*ased standards for inherently decidin& that the *est $e can do no$ is more important than continuous improvement .D</! ?ne could" of course" ar&ue $ith that very calculus" as the President>s chief of staff prominently did recently in the health-care de*ate .there are a lot of people!!!$ho $ill tell you $hat the ideal plan is! Preat" fascinatin&! Jou have the art of the possi*le measured a&ainst the ideal!/ .D+/! 3 think there are also t$o more o*1ective reasons to *e less enamored of risk-*ased performance &oals in li&ht of the ne$ potential of SFRA: .</ in the past" technolo&y-*ased standards have not &enerally had the risk*ased check and *alance 3 advocate here : so if current technolo&y is ample to reduce net risk to accepta*ly lo$ levels .as indicated *y a thorou&h risk assessment/" there should *e no concern a*out lockin& in that level of pollution) and .+/ do performance &oals really unfree0e technolo&ical innovationM any risk-*ased limits could *e ti&htened over time to spur further control technolo&ies" *ut in practice the limits themselves are fro0en *y lack of a&ency attention and political $ill .?SEA" for e%ample" has only ti&htened three PE(s in its ;--year history/! EPA has ti&htened some of the BAA7S limits for criteria pollutants" *ut it is not clear ho$ often the periodic movin& of the *ar has spurred innovation" as opposed to cases $here innovation emer&ed independently and allowed EPA to move the *ar! 8ontinuous improvement re2uires continuous vi&ilance" and 3 think that is more a function of resources and $ill than the type of re&ulatory instrument! H!- ;overnment should be doing less *central planning,, not much! more. Bo$ is surely an inopportune time" perhaps even a tone-deaf time" to *e proposin& somethin& that could *e dismissed as socialism! 3n addition to the ideolo&ical *attle lines SFRA may dra$" less visceral concerns have lon& *een e%pressed a*out the appropriateness of &overnment meddlin& in technolo&ical choices and the inefficiency of interventions that

;= do not encoura&e fle%i*ility amon& means of compliance *y firms and sectors $ith very different economic characteristics.D;/! 3 a&ree $ith the latter o*1ection" and support a *rand of SFRA that considers marketa*le permits" hy*rid performance-specification standards .see Section C a*ove/" and other many si0es fit all approaches amon& solutions that should *e evaluated! As to the ineptness or effrontery of &overnment assessin& technolo&ies" 3 can only point out .$ithout implyin& any preference for the status 2uo or for radical chan&e/ that society picks $inners and losers all the time in other arenas of social policy! Amon& the su*stances that can produce mild euphoria" $e allo$ .and su*sidi0e some of the in&redients of/ *evera&e alcohol" *ut $e criminali0e mari1uana! Amon& the products of the firearms industry" $e dra$ a line $ith hand&uns and huntin& rifles on one side" and machine &uns on the other! 5e do all this without conductin& any cost-*enefit analyses .considerin& neither the consumer and producer surplus if *anned products $ere decriminali0ed" nor the health risks of le&al products/6 so $hat $ould *e so odd a*out promotin& .or re&ulatin&/ one type of li&ht*ul* over another" $ith the help of risk and cost informationM SFRA may *e re1ected on the &rounds it is too intrusive" *ut my o$n opinion is that $ould *e reasona*le *ut naive considerin& the de&ree of intrusion" for &ood or ill" in today>s marketplace! H!<, We:re doing well enough without a new decision+making paradigm. Althou&h this is even more su*1ective than the previous criticism .is your environmental &lass halfempty or half-fullM/" the 2uestion must *e asked: is SFRA .pun intended/ a solution in search of a pro*lemM 3f our pro&ress to$ards reducin& environmental" health" and safety risks" at reasona*le costs to the economy" is lauda*le" then any meddlin& $ith the current system is a risky attempt to fi% $hat isn>t *roken! There is ample support for this proposition" especially $hen one looks at the variety of key environmental indicators that have moved steadily in the ri&ht direction since <-H," such as the -+ percent drop in air*orne lead" the controllin& of -D percent of the rou&hly +",,, contaminated sites in the R8RA pro&ram *et$een +,,, and +,,=" and the increase since <--, from rou&hly =, percent to rou&hly -, of the population served *y community drinkin& $ater systems that had no reported violations of any health-*ased drinkin& $ater standards!

;Althou&h a full analysis of these trends and the many countervailin& ones is far *eyond the scope of this article" 3 think there is room for serious de*ate $hether sufficient pro&ress has indeed *een made" not$ithstandin& the o*vious retort that no matter ho$ no*le the track record" $e mi&ht al$ays *e a*le to do *etter still! Eere are some areas $here lack of pro&ress su&&ests a role for a ne$ decision-makin& paradi&m: ?ther trends in environmental concentration are not so favora*le: some of the other criteria pollutants have fallen sli&htly on avera&e" *ut less so at the upper ends of the distri*ution .the -,th percentile of P
<,

concentrations fell only

from <<; &Am; to == &Am; *et$een <--H and +,,=" and the same measure for o0one only fell from -H to =H .pp*/" $hile B?% levels continue to rise across-the-*oard! Some of the air to%ics concentrations have not declined all .<";-*utadiene levels $ere sta*le from <--C to <--=/! ore importantly" the atmospheric 8?+ level has risen from ;+D ppm in <-H+ to ;=D ppm in +,,=! 3ndicators of pro&ress in other areas of risk mana&ement have reached an asymptote .as in the num*er of fatal occupational in1uries/ or are increasin& .as in the num*er of food*orne illnesses" and the concentrations of many $orkplace pollutants/! Trends in disease incidence and mortality reveal a mi%ed record" $ith decreases in many cancers amon& adults offset *y increases in childhood cancers" and rates of asthma" autism" and other conditions increasin& *eyond $hat improved detection or reportin& can likely e%plain! 9ut all of these metrics evaluate only half of the evolution in environmental mana&ement! Since SFRA is a*out opportunities" it is fair to ask also $hether the sources of environmental stress are evolvin& relative to reasona*le e%pectations! The &old standard for rapid technolo&ical innovation since <-H, has *een the *reakneck pace of improvements in computer technolo&y: today>s UC,, desktop has +, million times the stora&e capacity" + million times the RA " and +,,, times faster processin& speed than the computer that &uided Apollo << to the moon in <-D-! And yet"

C, +<, of the <,C@ makeAmodel com*inations of cars sold in +,,; achieved lo$er mp& than the <-H- 8adillac Eldorado) D@ percent of '!S! homes are poorly insulated" $astin& *illions of &allons of fossil fuels annually) $e still dry-clean clothes usin& chlorinated solvents" that create si&nificant risks even in homes far from laundries" 1ust from the e%haled *reath of $orkers $hen they return home at ni&ht .DC/ .and the EPA phaseout of perchloroethylene *y the end of +,+, applies only to cleaners co-located in residential *uildin&s" not those $hich emit into ad1acent $orkplaces or freestandin& esta*lishments/) in <-H," the ma1or source of drinkin& $ater $as the kitchen sink and the $ater fountain: today" $e in the '!S! purchase rou&hly ;@ *illion plastic *ottles of $ater each year" $ith implications for ener&y use and human health! 5e may end up satisfied $ith the pace of innovation in products and processes that impact on the environment" *ut surely a decision-makin& paradi&m that dares to ask the 2uestion can it *e done *etterM is not outlandish ho$ uneven the rise of ne$ and *etter ideas has *een across the various sectors of the economy!

!. "rgani#ational Change to $ %le ent Solution-Focused Assess ent The final chapter of Science and Decisions offered various infrastructure recommendations to increase the a*ility of federal and state a&encies to mana&e risks accordin& to the Frame$ork the 8ommittee endorsed" and emphasi0ed the value of craftin& ne$ &uidance documents" creatin& or&ani0ation-$ide teams to pick tar&ets for innovative decision-makin&" and developin& the technical skills necessary for mana&ers and assessors to colla*orate more productively! 3n addition to these improvements" ho$ever" more fundamental chan&e may *e necessary! ?ne current proposal for the creation of a #epartment of Environmental and 8onsumer Protection.D@/" incorporatin& si% e%istin& a&encies and addin& *ureaus to conduct environmental and health

C< surveillance" emphasi0ed the a*ility of such an or&ani0ation to re&ulate products .as opposed to su*stances per se" $hich may make less and less sense as ne$ nanomaterials emer&e $hose risks depend completely on ho$ they are incorporated into finished products/ and to produce social impact statements of the impacts of technolo&ies! 3n addition to *old ideas such as those #avies has put for$ard" 3 ur&e serious thou&ht *e &iven to a some$hat less s$eepin& or&ani0ational chan&e: the creation of a true intera&ency risk mana&ement colla*oration mechanism" either under the auspices of ? 9A?3RA or .prefera*ly" in my vie$/ under an e%panded 5hite Eouse ?ffice of Science and Technolo&y Policy! So many of the solutions one a&ency impels can affect risks in other a&encies> purvie$ : andAor can put society on a path that makes opportunities for future risk reduction in another area more e%pensive or impossi*le : that it seems *i0arre for the environmental" occupational" transportation" ener&y" housin&" a&riculture" and other functions of &overnment to pursue separate re&ulatory and informational a&endas! Past ?3RA administrators have claimed intera&ency colla*oration amon& their priorities and achievements.DD/" *ut in my limited e%perience .as ?SEA>s representative to several of these &roups *et$een <--@ and +,,,/" $hile there $as e%tensive colla*oration around le&islative issues .nota*ly the re&ulatory reform proposals/" issues that involved risk transfers" duplication of effort" or inconsistent re2uirements across t$o or more a&encies $ere rarely an opportunity for true colla*oration) rather" they prompted ?3RA to orchestrate one a&ency>s a2uiescence to the plans of another .for e%ample" to $rite letters attestin& that alle&ed risk-risk transfers $ere not si&nificant/! 3n contrast" *rainstormin& a*out solutions and opportunities could flourish if ?3RA $as $illin& .perhaps *y reallocatin& its si&hts and resources some$hat a$ay from intense rule-*y-rule oversi&ht" a development some $ould $elcome on its o$n merits/ to prompt a&encies to $ork to&ether on interventions $hose ideal solutions depend on multiple perspectives" and to develop their o$n plans to solve pro*lems revealed *y" or e%acer*ated *y" the actions of another a&ency! The notion of a forest &roup lookin& *roadly at options to minimi0e contradictory interventions and increase $inA$in coordination is reminiscent of the proposal then-Vud&e Stephen 9reyer made <@ years a&o .DH/ for a coherent risk re&ulatory system that $ould involve far more meanin&ful intera&ency colla*oration than harmoni0in& allometric scalin&.D=/ or a&reein&

C+ not to comment on another a&ency>s rule" althou&h 9reyer did not envision a solutionfocused approach to risk mana&ement or a central role for the pu*lic in technolo&y options analysis .D-/!

&. A S%eci'ic ()a %le Althou&h they $ere not included in the main *ody of the report" the Science and Decisions 8ommittee pu*lished three short case studies of ho$ risk-*ased decisionmakin& could involve" as Appendi% F of its report! 3n addition to a hypothetical discussion of the sitin& of a ne$ po$er plant in a lo$-income nei&h*orhood .in $hich the &overnment" the community" and the utility company mi&ht discuss the risks and *enefits of the proposal as $ell as alternative desi&ns and locations/ Appendi% F contained a *rief discussion of continuous improvement in maintainin& a community drinkin& $ater system!<C The third case study also *rin&s in issues of risk-risk transfer and life-cycle solutions" and 3 $ill *riefly e%pand upon it here! Suppose that EPA and ?SEA $ere each considerin& ho$ to reduce human e%posures to methylene chloride . 8/" and $ere considerin& .on their o$n accord or *y promptin& from ?3RA/ $orkin& 1ointly on one important source of strippin& of paint from aircraft! Ta*le 3 depicts four different kinds of risk mana&ement 2uestions the a&encies could ask" movin& from the least to the most solution-focused and from the narro$est to the *roadest ran&e of solutions! The first t$o ro$s depict the traditional su*stancespecific .and *ureaucratically compartmentali0ed/ approach: each a&ency separately sets an e%posure .or emissions/ limit for this operation! The only technical analysis re2uired for this decision is a dose-response assessment" althou&h at ?SEA" if this sector .aircraft 8 e%posure: the

<C

A recent op-ed .H,/ tackled the safe drinkin& $ater pro*lem from a novel solution-focused perspective: the author su&&ested that drinkin& $ater could *e made even safer via the installation of point-of-use filters on household taps used for drinkin& and cookin& $ater" $hile taps used for laundry and toilet $ater could instead meet a sli&htly rela%ed set of to%ic contaminant levels! This idea spran& from the 2uestion ho$ can $e provide $ater safe enou&h for its intended useM" not from $hat is the accepta*ly safe concentration of each su*stance in household $aterM

C; repaintin&/ $as the one that had the most difficulty meetin& the one-si0e-fits-all PE( for 8" the a&ency mi&ht have to ensure that the technolo&y to achieve the PE( $as economically feasi*le for this sector! The imposition of the e%posure-limit solution could result in ade2uate compliance .$hich $ould have to *e verified *y chemical samplin& and analysis/" or in non-compliance" or in any of at least three kinds of unfortunate riskrisk trade-offs: .</ the repainters could su*stitute a more to%ic material for 8<@) .+/ dependin& on the va&aries of economics and enforcement" they could comply $ith the EPA re2uirement *y decreasin& ventilation in han&ars or spray *ooths" or $ith the ?SEA re2uirement *y increasin& it6either $ay" transferrin& e%posure to or from the $orkplace rather than reducin& it.H;/) or .;/ they could repaint less often" $hich conceiva*ly could result in mechanical defects underneath the paint &oin& unnoticed! The third ro$ is a hi&hly simplified summary of technolo&y-*ased thinkin& uninformed *y risk analysis: the controls already used else$here in this sector are presumed to *e afforda*le" and compliance is presuma*ly more likely and is easier to verify" *ut the de&ree of risk reduction .$ith or $ithout considerin& offsettin& risks/ is not &au&ed! The fourth ro$ asks the most *asic solution-focused 2uestion: $hat are the risks and costs of methods to fulfill the functionM .defined for the moment as freshly-painted aircraft/! 3t is possi*le that mechanical removal of old paint" usin& more or less a*rasive materials" could emer&e as the method providin& the &reatest net *enefit" and not incidentally one that defuses the potential 0ero-sum risk transfers .assumin& there are no si&nificant er&onomic risks to the $orkers handlin& the ne$ spray &uns/! The fifth ro$ supposes that the a&encies .perhaps 1oined here *y #?E and #?T" $ho have a vested interest in fuel economy/ choose to ask a more fundamental solutionfocused 2uestion: could the function *e fulfilled $ithout the cycle of paintin&" strippin&" inspectin&" and repaintin& aircraftM American Airlines implemented its o$n ideal final

<@

This is a hi&hly plausi*le scenario6for e%ample" after ?SEA>s 8 re&ulation $as promul&ated in <--H" manufacturers *e&an a&&ressively toutin& an unre&ulated su*stitute .<-*romopropane/" despite its kno$n neuroto%ic properties and close structural relationship to several animal carcino&ens .H</! The *rominated material is no$ also *ein& used as a su*stitute for perchloroethylene in dry cleanin&! .H+/!

CC result.C,/ on its o$n accord some years a&o" and no$ saves H million &allons of 1et fuel per year *y coatin& the *are metal rather than paintin& it! There is no reason that &overnment" industry" and the affected pu*lic couldn>t convene and ask even more pro*in& 2uestions a*out the function of air travel: to the e%tent that some portion of it serves to *rin& people to&ether for face-to-face meetin&s" aidin& innovation in the sector that provides virtual su*stitutes for in-person meetin&s mi&ht derive still more net *enefit *y reducin& ener&y use and the other e%ternalities of air travel! The solution focused 2uestion can *e as am*itious as the participants desire: the point of this e%ample" re&ardless of $here the reader *alks at the *readth of the solution" is that no innovation beyond *less )< e%posure to some or all of the affected persons, would be part of a decision process that defined the problem before considering the opportunities.4= Sie$ed this $ay" 3 hope it is clear that the traditional paradi&m can do no *etter than to provide an optimal ans$er to a su*-optimal 2uestion!

*+. Conclusions Risk assessment for its o$n sake is an inherently valua*le activity" *ut at *est" a risk assessment can illuminate $hat $e should fear : $hereas a &ood solution-focused analysis can illuminate $hat $e should do! 3n the same vein" the search for an accepta*le level of risk is motivated *y the no*le desire to do less harm" *ut there is a different &oal possi*le6to do more &ood! This latter orientation re2uires us to see opportunities $here $e are tempted to see only ha0ards to a*ate! A&ain" 3 have never *elieved that risk assessment is or must *e that $hich keeps the death camp trains runnin& on time.HC/" so 3 think $e need to *e a$are that there are alternative visions that take risk assessment out of the e2uation in the vain hope that precaution or *est availa*le technolo&y alone can make the choices facin& us less tra&ic .H@" HD/!

<D

Similarly" definin& the medical pro*lem in Section C a*ove as uncomforta*le pants $ould foreclose thinkin& a*out diet and e%ercise .*i&&er pants *ein& a cheap and effective solution to this pro*lem/!

C@ The notion that analysts and decision makers must interact is no lon&er controversial! And in a steady manner" others have moved the center of &ravity of our field &radually to$ards the conclusion that decision options .solutions/ should *e arrayed earlier and earlier in the process than the Red .or the is-read.HH// *ook ori&inally intended! Science and Decisions is to date the culmination of this for$ard motion to turn risk assessors loose to evaluate solutions rather than ha0ards" and so this proposal for SFRA is incremental in that it moves the initial enumeration of possi*le solutions to the very *e&innin& .after the si&nal of harm is deemed si&nificant/ rather than closer to the *e&innin& as in Science and Decisions! 3t is much more than incremental" thou&h" if 3 am correct that it is much more difficult to see the situations $e confront in risk mana&ement as *oth pro*lems and opportunities unless $e formulate and scope in a $ay that initially keeps all opportunities open" until such time as analysis finds them to *e impermissi*le or clearly dominated *y other availa*le responses! 3 offer this proposal out of concern for human health and the environment" *ut also out of concern" misplaced or le&itimate" for our shared profession of risk analysis! 3 look around at our unfinished risk-reduction *usiness and *elieve that *older solutions are $orth contemplatin&" and that &overnment : in the sense of officials actin& in concert $ith the re&ulated and the affected6must play a &reater role in envisionin& specific technolo&ies and lifestyle chan&es than it has in the past! 9ut 3 also look around and see others $ho share the sense of ur&ency a*out &oals *ut $ho are contemptuous of risk analysis as a means! The marria&e of technolo&y options analysis and risk analysis is especially compellin&" 3 *elieve" $hen vie$ed $ith eyes open as an alternative to technolo&y-*ased interventions without risk analysis" or precaution $ithout assessment" or e%posure limits $ithout considerin& $hether too much or too little cost accompanies them! Perhaps a train is comin& do$n the track $herein some ne$ $ays $ill *e promoted for protectin& human health and the environment6some $ise" others less so" and still others counter-productive or $orse! 3f so" $e risk assessors should *e on *oard that train" prefera*ly .in my vie$/ in the lead car alon& $ith the conductor and the en&ineer" not $atchin& it &o *y $hile $e display our erudition and understandin& of ha0ards! And if that train is not already on the track" perhaps $e risk assessors should put it there!

CD

Ackno$led&ements: 3 &ratefully ackno$led&e the research assistance provided *y Alison 9onelli" and the many informative conversations 3 had $ith mem*ers of the Science and Decisions committee durin& +,,D-+,,=!

CH

$"#"$" ("S <! Bational Research 8ouncil .<-=;/! Risk Assess ent in the Federal ,overn entManaging the Process .the Red 9ook/! Bational Academy Press! +! Bational Research 8ouncil .<--C/! Science and .udg ent in Risk Assess ent. Bational Academy Press! ;! Eattis" #!" S! 9aird" and R! Po*le .+,,+/! A Stra$ an Proposal for a 7uantitative #efinition of the Rf#! 2rug <hem "o%icol" /0:C,;-C;D! C! (ut0" 5!4! .+,,</! Suscepti*ility #ifferences in 8hemical 8arcino&enesis (ineari0e the #ose-Response Relationship: Threshold #oses can *e #efined ?nly for 3ndividuals! )utation Research, 1!/:H<-HD! @! #ennis V! Pausten*ach .<--@/: Retrospective on '!S! Eealth Risk Assessment: Eo$ ?thers 8an 9enefit! R/#>. Health, #afety ? Environment, 6-+=;- ;;+! D! 3ndustrial 'nion #epartment" AF(-83? v. American Petroleum 3nstitute .<-=,/! CC= '!S! D,H .Supreme 8ourt/! H! Finkel" A! ! and P!9! Ryan .+,,H/! Risk in the 5orkplace: 5here Analysis 9e&an and Pro*lems Remain 'nsolved! 8hapter - .pp! <=H-+;H/ in Risk Assess ent 'or (nviron ental 2ealth" Association of Schools of Pu*lic Eealth . !P! Ro*son and 5!A! Toscano" eds!/" Vohn 5iley L Sons 3nc! =! Eattis" #ale" and Eli0a*eth Anderson .<---/! 5hat Should 9e the 3mplications of 'ncertainty" Saria*ility" and 3nherent O9iases>A O8onservatism> for Risk ana&ement #ecision- akin&M Risk Analysis" *&3*4:-@-<,H! -! Environmental Protection A&ency .+,,=/! Bational Am*ient Air 7uality Standards for ?0one! $ederal Register, 75- <DC;@-<D@<C" arch +H! <,! 4eeney" Ralph and #etlof von 5interfeldt" 5hy 3ndirect Eealth Risks of Re&ulations Should *e E%amined! /nterfaces, *6- <;-+H .<-=D/! <<! Praham" Vohn and Vonathan 5iener" eds" .<--@/! Risk 6ersus Risk- 7radeo''s in Protecting 2ealth and the (nviron ent. Earvard 'niv! Press! <+! Sunstein" 8ass .<--D/! Eealth-Eealth Tradeoffs! @niv. of <hicago 7aw Review, 65<@;;-H<! <;! 5iener" Vonathan .<--=/! ana&in& the 3atro&enic Risks of Risk R/#>. Health, #afety ? Environment &- ;--=+! ana&ement!

<C! Rascoff" Samuel and Richard Reves0 .+,,+/! The 9iases of Risk Tradeoff Analysis: To$ards Parity in Environmental and Eealth-and-Safety Re&ulation! @niv. of <hicago 7aw Review, 6&- <HD;-<=;D!

C= <@! Finkel" Adam ! .+,,H/! #istin&uishin& (e&itimate Risk-Risk Tradeoffs from Stra$ en! Presentation at the Annual eetin& of the Society for Risk Analysis" San Antonio" TI" #ec! <<! <D! Bational Research 8ouncil .+,,-/! Science and Decisions- Advancing Risk Assess ent. 8ommittee on 3mprovin& Risk Analysis Approaches 'sed *y the '!S! EPA" Bational Academy Press" 5ashin&ton" #8" 3S9B -H=-,-;,--<+,CD-;" C,; pp! <H! Schnoor" Verald (! .+,,-/! (8A and Environmental 3ntelli&enceM8 Environmental #cience ? "echnology" 153&4- +--H! <=! Ackerman" 9ruce A!" and Richard 9! Ste$art .<-=@/! Reformin& Environmental (a$" #tanford 7aw Review, 57304- <;;;-<;D@! <-! (atin" Eo$ard .<-=@/! 3deal versus Real Re&ulatory Efficiency: 3mplementation of 'niform Standards and OFine- Tunin&> Re&ulatory Reforms" #tanford 7aw Review, 57304- <+DH-<;;+! +,! c8u**in" Patricia Ross .+,,@/! The Risk in Technolo&y-9ased Standards" 2uke Environmental 7aw ? 6olicy $orum, *63*4- <-@D!

+<! '!S! Senate .+,,</! 2isapproval of 2epartment of 7abor Ergonomics Rule. <ongressional Record, *173/!4, pp! S<=;<-S<===" arch D! ++! Shapiro" Stuart .+,,H/! The Role of Procedural 8ontrols in ?SEA>s Er&onomics Rulemakin&! 6ublic Administration Review, 67314- D==-H,<! +;! '!S! Environmental Protection A&ency .+,,@/! Bational Emission Standards for 8oke ?ven 9atteries) Final Rule! $ederal Register, 7+37/4- <---<-+,,<@" April <@! +C! Q$etsloot" Perard 3! V! ! and Bicholas Askounes Ashford .+,,;/! The feasi*ility of Encoura&in& 3nherently Safer Production in 3ndustrial Firms! Safety Science" 1*3/-54- /*&-/1+. +@! ?>9rien" ary .+,,,/! Making 9etter (nviron ental Decisions- An Alternative to Risk Assess ent. 3T Press" 8am*rid&e" A" +=D pp!" 3S9B ,-+D+-D@,@;-;! +D! Environmental Protection A&ency .<-=H/! :n'inished 9usiness- A Co %arative Assess ent o' (nviron ental Pro;le s. ?ffice of Policy Analysis! +H! Environmental Protection A&ency .<--,/! Reducing Risk- Setting Priorities and Strategies 'or (nviron ental Protection. Science Advisory 9oard .A-<,</" SA9E8--,-,+<! +=! Finkel" Adam ! and #ominic Poldin&" eds! .<--C/! <orst 7hings First= 7he De;ate "ver Risk-9ased National (nviron ental Priorities. Resources for the Future" 5ashin&ton" #8" 3S9B ,--<@H,H-HC-=" ;C= pp! +-! 8ommoner" 9arry .<--C/! Pollution Prevention: Puttin& 8omparative Risk Assessment in its Place! 8hapter <C in Finkel and Poldin&" <--C!

C;,! 9ullard" Ro*ert #! .<--C/! 'ne2ual Environmental Protection: 3ncorporatin& Environmental Vustice in #ecision akin&! 8hapter <D in Finkel and Poldin&" <--C! ;<! Ashford" Bicholas .<--C/! An 3nnovation-9ased Strate&y for the EnvironmentM 8hapter <= in Finkel and Poldin&" <--C! ;+! (om*or&" 91orn" ed! .+,,C/! ,lo;al Crises, ,lo;al Solutions. 8am*rid&e 'niversity Press" 8am*rid&e" '4" 3S9B ,-@+<-D,D<C-C" DC= pp! ;;! (om*or&" 91orn" ed .+,,D/! 2o> to S%end ?0+ 9illion to Make the <orld a 9etter Place. 8am*rid&e 'niversity Press" 3S9B -H=-,-@+<-=DDH--=! ;C! Raiffa" Eo$ard" and Ro*ert Schlaifer .<-D</! A%%lied Statistical Decision 7heor@. Praduate School of 9usiness Administration" Earvard 'niversity" 3S9B -H=,=H@=C,<H=" ;@D pp! ;@! 4eeney" Ralph .<--+/! 6alue-Focused 7hinking- A Path to Creative Decision aking. Earvard 'niversity Press" 3S9B -H=-,-DHC--;<-H-=" C;+ pp! ;D! 8lemen" R!T! <--D! akin& Eard #ecisions: An 3ntroduction to #ecision Analysis" Second Edition" #u%*ury Press" Pacific Prove" 8A! ;H! Borth" #!5arner" R!A! Eo$ard and V!E! Eurricanes! #cience" *76: <<-<-<+,+! atheson .<-H+/! The #ecision to Seed

;=! Poldstein" 9ernard #! .<--;/! 3f Risk ana&ement is 9roke" 5hy Fi% Risk AssessmentM E6A Aournal, Van!AFe*!A arch" pp! ;H-;=! ;-! 5illiam Eudson ?>Eanlon and ichele 5einer-#avis .<-=-/! $n Search o' Solutions- A Ne> Direction in Ps@chothera%@. 55 Borton and 8o!" Be$ Jork" 3S9B -H=-,;-;H,,D<-" <-< pp! C,! #om*" Ellen .<--H/! The 3deal Final Result: Tutorial! ?nline essay at http:AA$$$!tri0-1ournal!comAarchivesA<--HA,+AaAinde%!html! C<! 9erry" 5endell .+,,+/! Solvin& for Pattern in "he Art of the <ommonplace. "he Agrarian Essays of Wendell 'erry .+,,+/! C+! 8ivic Practices Bet$ork" 9randeis 'niversity .undated/! The Tacoma Smelter and EPA! Accessed at http:AA$$$!cpn!or&AtopicsAenvironmentAtacoma!html C;! Bational Research 8ouncil .<--D/! :nderstanding Risk- $n'or ing Decisions in a De ocratic Societ@! 5ashin&ton #8: Bational Academy Press! CC! Tickner" Voel" and Tami Pouveia-Si&eant .+,,@/! The <--< 8holera Epidemic in Peru: Bot a 8ase of Precaution Pone A$ry" Risk Analysis. /0354- C-@-@,+! C@! Sunstein" 8! +,,+! Risk and reason: Safety" la$ and the environment! 8am*rid&e 'niversity Press!

@, CD! Finkel" Adam !" Eldar Shafir" Scott Ferson" 5inston Earrin&ton" et al! .+,,D/! "ransferring to Regulatory Economics the Risk+Analysis Approaches to @ncertainty, /nterindividual Bariability, and Cther 6henomena. Bational Science Foundation &rant W,H@D@;-" #ecision" Risk" and 'ncertainty pro&ram .Euman and Social #ynamics of 8han&e competition/! CH! Finkel" Adam ! .+,,-/! #o Risk Assessors and Re&ulatory Economists Approach 'ncertainty And Saria*ility #ifferentlyM Presentation at the Society for Risk Analysis annual meetin&" #ecem*er H" 9altimore" #! C=! Evans" V!S!" V!#! Praham" P! ! Pray" and R!(! Sielken! <--C! A #istri*utional Approach to 8haracteri0in& (o$-#ose 8ancer Risk! Risk Anal! <C.</:+@-;C! C-! 8ooke" Ro&er !" ed! .+,,-/! :ncertaint@ Modeling in Dose Res%onse- 9ench 7esting (nviron ental 7o)icit@. Vohn 5iley and Sons" Eo*oken" BV" 3S9B -H=-,CH,-CCH@,-@" +;, pp! @,! Finkel" A! ! .<--D/! 5ho>s E%a&&eratin&M #iscover" ay <--D" pp! C=-@C!

@<! Jukota" F! and 4! Thompson .+,,C/! The Salue of 3nformation in Environmental Eealth Risk ana&ement #ecisions: Past" Present" Future" Risk Analysis /1.;/:D;@D@,! @+! Finkel" A! !" and V!S! Evans .<-=H/! Evaluatin& the 9enefits of 'ncertainty Reduction in Environmental Eealth Risk ana&ement! Aournal of the Air 6ollution <ontrol Association, 573*+4: <<DC-<<H<! @;! PresidentialA8on&ressional 8ommission on Risk Assessment and Risk ana&ement .<--H/! $ramework for Environmental Health Risk )anagement - Final Report" Sol! <! FonlineG! Availa*le: http:AA$$$!risk$orld!comAnreportsA<--HAriskrptApdfAEPAVAB!P#F! @C! Bational Research 8ouncil .+,,@/! Risk and Decisions a;out Dis%osal o' 7ransuranic and 2igh-Aevel Radioactive <aste. 5ashin&ton" #8" Bational Academy Press! @@! Ee&stad" aria .+,,-/! EPA Seeks to (imit Risk Assessment! /nside E6A" 5+3*4- Vanuary -! ana&ement 8onsiderations in

@D! #riesen" #avid" and Alyson 8! Flournoy" eds! .+,,-/! 9e@ond (nviron ental Aa>Polic@ Pro%osals 'or a 9etter (nviron ental Future. 8am*rid&e 'niversity Press" 3S9B -H=-,@+<HCC;+C" +-D pp! @H! Alon Tal .<--H/" A Failure to En&a&e" "he Environmental $orum" VanAFe*!" pp! <;+<! @=! Richard Reves0 and ichael (ivermore .+,,=/! Retakin& Rationality: Eo$ 8ost 9enefit Analysis 8an 9etter Protect the Environment and ?ur Eealth! ?%ford 'niversity Press" 3S9B -H=-,<-@;D=@HC" +D+ pp!

@< @-! Finkel" Adam ! .<--C/! Risk Assessment Research: ?nly the 9e&innin&! Risk Analysis, *1364- -,H--<<! D,! Pi**" Steve .+,,-/! Front-(oadin& ana&ers> 3nput in the Risk Assessment Process: 3ssues and 8oncerns! E) .Environmental ana&ement" Air and 5aste ana&ement Association ne$sma&a0ine/ pp! +D-+-" Vuly! D<! #o$er" Ro&er" et al!" eds! .<--H/! Frontiers o' Sustaina;ilit@- (nviron entall@ Sound Agriculture, Forestr@, 7rans%ortation, and Po>er Production. 3sland Press" 5ashin&ton" #8" 3S9B -H=-<@@-D;@CD+" ;=< pp! D+! Stol*er&" Sheryl Pay .+,,-/! #emocrats Raise Alarms over Eealth 9ill 8osts! 8ew Dork "imes, Bov! <," pa&e A<! D;! 5ilson" Vames #! .<--C/! Promotin& 3nnovation OThe Easy 5ay>! 8hapter <- in Finkel and Poldin&" <--C! DC! A&&a00otti" Pa*riella" Pu&lielmina Fantu00i" Puerrino Predieri" Elena Ri&hi" and Stefania oscardelli .<--C/! 3ndoor E%posure to Perchloroethylene .P8E/ in 3ndividuals (ivin& 5ith #ry-8leanin& 5orkers! #cience of the "otal Environment, *06- <;;-<;H! D@! #avies" V! 8larence .+,,-/! Cversight of 8e%t ;eneration 8anotechnology. 5oodro$ 5ilson 3nternational 8enter for Scholars" April +,,-" ;- pp! DD! 'niversity of Pennsylvania (a$ School .+,,D/! 6residential Cversight. A 6anel 2iscussion with Regulatory *<(ars, from Reagan to 'ush. #ecem*er D! Forthcomin& report) currently availa*le online at http:AA$$$!re&info!&ovApu*licA1spAE?AfedRe&Revie$Apu*lic8omments!1sp .8omment W<=</! DH! 9reyer" Stephen .<--;/! 9reaking the 6icious Circle- 7o>ard (''ective Risk Regulation" .Earvard 'niv! Press/! D=! '!S! Environmental Protection A&ency .<--+/! 2raft Report. A <ross+#pecies #caling $actor for <arcinogen Risk Assessment 'ased on Equivalence of mg0kgE0F0day. $ederal Register %): +C<@+-+C<H;! Vune @! D-! Finkel" A! ! .<--@/! A Second ?pinion on an Environmental isdia&nosis: The Risky Prescriptions of 'reaking the Bicious <ircle! 8ew Dork @niversity Environmental 7aw Aournal" 5: +-@-;=<! H,! ;! H<! a1ersik" Vennifer V!" et al! .+,,H/! Severe Beuroto%icity Associated $ith E%posure to
the Solvent <-9romopropane .n-propyl *romide/! <linical "o%icology, 10- +H,-D!

orris" Ro*ert #! .+,,H/! Pipe #reams" 8ew Dork "imes .op-ed column/" ?cto*er

@+ H+! 8enters for #isease 8ontrol and Prevention .+,,=/! Beurolo&ic 3llness Associated $ith
?ccupational E%posure to the Solvent <-9romopropane 6Be$ Versey and Pennsylvania" +,,H-+,,=! )orbidity and )ortality Weekly Report, 0731!4- <;,,-+" #ec! @!

H;! '!S! Environmental Protection A&ency" '!S! ?ccupational Safety and Eealth Administration" and Bational 3nstitute for ?ccupational Safety and Eealth .<---/! <ommon #ense Approaches to 6rotecting Workers And the Environment. /nteragency <ooperation towards <ooperative #olutions. 5orkshop held in 5ashin&ton" #8" Vune <H-<= .a&enda and other materials on file $ith author/! HC! onta&ue" Peter .<--D/! Ethical Ea0ards of Risk Assessment! Rachel:s Environment ? Health Weekly, Bovem*er H!

H@! 8ala*resi" Puido" and Philip 9o**itt .<-H=/! 7ragic Choices 37he Fels Aectures on Pu;lic Polic@ Anal@sis. 5!5! Borton and 8o!" 3S9B -H=-,;-;,-,=@H" +@+ pp! HD! onta&ue" Peter" and Adam ! Finkel .+,,H/! T$o Friends #e*ate Risk assessment and Precaution! From Rachel:s 2emocracy ? Health 8ews, &/+, Au&! <D! Archived at http:AA$$$!rachel!or&AenAne$slettersArachelsXne$sA-+,WT$o-Friends#e*ate-Risk-Assessment-and-Precaution! irer" Franklin E! .+,,;/" #istortions of the is-Read> 9ook: Addin& Procedural 9oto% to Paralysis *y Analysis" Human and Ecological Risk Assessment, &304, pp! <<+--<<C;!

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@C F3P'RE + A Pestalt #ia&ram

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