Transcript
  • 8/13/2019 sfra article final draft.doc

    1/55

    Solution-Focused Risk Assessment: A Proposal for

    The Fusion of Environmental Analysis and Action

    Adam ! Finkel" Sc!#!Fello$ and E%ecutive #irectorPenn Pro&ram on Re&ulation

    'niversity of Pennsylvania (a$ School

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

  • 8/13/2019 sfra article final draft.doc

    2/55

    Abstract:

    Rethinkin& risk assessment as a method for helpin& to solve environmental pro*lems"rather than .merely/ understandin& environmental ha0ards" may provide three ma1orclasses 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$ toachieve 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 oftenmore 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 optimaldecisions" ones that resolve multiple risks simultaneously" avoid needless and tra&ic risk-risk 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 thedetriment of human health" the environment" and the economy! Therefore" 3 propose ane$ solution-focused risk assessment paradi&m" in $hich the tentative arrayin& ofcontrol decisions $ouldprecedeand &uide the assessment of e%posures" potencies" andrisks!

    4ey$ords: risk mana&ement" standard-settin&" decision theory" pu*lic involvement"technolo&y options

    +

  • 8/13/2019 sfra article final draft.doc

    3/55

    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& anythingto 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

    ;

  • 8/13/2019 sfra article final draft.doc

    4/55

    codified in the 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

  • 8/13/2019 sfra article final draft.doc

    5/55

    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 maychan&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

  • 8/13/2019 sfra article final draft.doc

    6/55

    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 non-

    e%istent or ne&li&i*le" andor 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!

    o$ever" in all other kinds of cases6$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%iccarcino&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 of a &iven su*stanceG does not

    face a lifetime e%cess cancer risk &reater than

  • 8/13/2019 sfra article final draft.doc

    7/55

    esta*lish an occupational e%posure concentration .the Permissi*le E%posure (imit" or

    PE(/ that comports $ith the

  • 8/13/2019 sfra article final draft.doc

    8/55

    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 decidedto

    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$ ?SA 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 .

  • 8/13/2019 sfra article final draft.doc

    9/55

    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! e can certainly try to solve this

    risk*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/! e 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

  • 8/13/2019 sfra article final draft.doc

    10/55

    3ntake .A#3/ in p&k&day! A Bational Academy of Sciences committee then rank-

    orders 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

  • 8/13/2019 sfra article final draft.doc

    11/55

    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 certainlysmarter 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 constraintsand 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

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

  • 8/13/2019 sfra article final draft.doc

    12/55

    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 ?SA" 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

  • 8/13/2019 sfra article final draft.doc

    13/55

    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:

  • 8/13/2019 sfra article final draft.doc

    14/55

    #$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 B3ES $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/! o$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 discussinga

    preferred solution can *e attacked as coercive" then *oth SFRA and the

  • 8/13/2019 sfra article final draft.doc

    15/55

    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 options-

    focused 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 asolution 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! o$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

  • 8/13/2019 sfra article final draft.doc

    16/55

    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+makersin 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 lessthan 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

  • 8/13/2019 sfra article final draft.doc

    17/55

    the environment .

  • 8/13/2019 sfra article final draft.doc

    18/55

    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 .s er&onomics role in +,,s share of opposition centered on its near absence of specific desi&n

    re2uirementsK.+ also re2uires the employer to *e an e%pert on er&onomicin1uries!

  • 8/13/2019 sfra article final draft.doc

    19/55

    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!

    o$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/ orchan&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

  • 8/13/2019 sfra article final draft.doc

    20/55

    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 halfof 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 $in$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

    +,

  • 8/13/2019 sfra article final draft.doc

    21/55

    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 .;

  • 8/13/2019 sfra article final draft.doc

    22/55

    SFRA also aspires to *e part of a tradition" datin& *ack at least as far as 9ernard

    oldstein>s t have to $ait

    states of nature and ho$ you mi&ht value them!

    ++

  • 8/13/2019 sfra article final draft.doc

    23/55

    passively for the miracle to occur! The parallels to environmental decision-

    makin& 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!

  • 8/13/2019 sfra article final draft.doc

    24/55

    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

  • 8/13/2019 sfra article final draft.doc

    25/55

    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

  • 8/13/2019 sfra article final draft.doc

    26/55

    evaluate the *enefits of e%posure reductions that move some individuals from

    a*ove the Rf8 .or *elo$ an ?E of

  • 8/13/2019 sfra article final draft.doc

    27/55

    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 across-

    the-*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

  • 8/13/2019 sfra article final draft.doc

    28/55

    current morass of confusion it has created around this issue.

  • 8/13/2019 sfra article final draft.doc

    29/55

    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! ?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 notpropose

    SFRA as 3 descri*e it here" and some cases may in fact *e its antithesis:

    The

  • 8/13/2019 sfra article final draft.doc

    30/55

    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 Presidential8on&ressional 8ommission on Risk

    Assessment and Risk ana&ement .P88RA/ released its t$o-volume

    report.@;/" a centerpiece of $hich $as its Frame$ork for Environmental

    ealth Risk 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! s emphasis on

    puttin& risks in conte%t! SFRA ur&es decision makers and the pu*lic to look

    for opportunities to broadentheir 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

    ;,

  • 8/13/2019 sfra article final draft.doc

    31/55

    to%icants reinforces and leads up to the su&&estion .p!

  • 8/13/2019 sfra article final draft.doc

    32/55

    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 usefulness

    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 increasedimportance of risk assessment in the ne$ paradi&m and a*out

    the readiness of risk assessors to deliver on the raisedG 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 uidelines 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

  • 8/13/2019 sfra article final draft.doc

    33/55

    a*out the pro*lem is valua*le" *ut it is actually the oppositeof 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 clearlyto 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 assessments $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 yesno 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 $ell-

    esta*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 Decisionsreport apparently did not $ish to open!

  • 8/13/2019 sfra article final draft.doc

    34/55

    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 Decisions8ommittee>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

    ;C

  • 8/13/2019 sfra article final draft.doc

    35/55

    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 $in$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. ere 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

    eor&e ray made this point at the SRA annual meetin& session on SFRA in #ecem*er

    ;@

  • 8/13/2019 sfra article final draft.doc

    36/55

    +,,=.@@/" 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" *othper seand 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!DAssessments performed for an #$RA may be useless for other purposes, leading to

    widespread and wasteful duplication of efforts. Accordin& to risk reporter Steve i**.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 .B3ES" B3?S" 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

    ;D

  • 8/13/2019 sfra article final draft.doc

    37/55

    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 reductionin 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

  • 8/13/2019 sfra article final draft.doc

    38/55

    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 helpof 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!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

  • 8/13/2019 sfra article final draft.doc

    39/55

    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! ere 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 ,thpercentile of P

  • 8/13/2019 sfra article final draft.doc

    40/55

  • 8/13/2019 sfra article final draft.doc

    41/55

    surveillance" emphasi0ed the a*ility of such an or&ani0ation to re&ulate products .as

    opposed to su*stancesper 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

    ?9?3RA or .prefera*ly" in my vie$/ under an e%panded 5hite ouse ?ffice of

    Science and Technolo&y Policy! So many of the solutions one a&ency impels can affect

    risks in other a&encies> purvie$ andor 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 ?SA>s

    representative to several of these &roups *et$een

  • 8/13/2019 sfra article final draft.doc

    42/55

    not to comment on another a&ency>s rule" althou&h 9reyer did not envision a solution-

    focused 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

    Decisions8ommittee pu*lished three short case studies of ho$ risk-*ased decision-

    makin& 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!

  • 8/13/2019 sfra article final draft.doc

    43/55

    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 risk-

    risk trade-offs: .s 8 re&ulation $as promul&ated in

  • 8/13/2019 sfra article final draft.doc

    44/55

    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 thee%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= ie$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" arisk assessment can illuminate $hat $e shouldfear $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/!

  • 8/13/2019 sfra article final draft.doc

    45/55

    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 Decisionsis 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 withoutrisk 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!

    C@

  • 8/13/2019 sfra article final draft.doc

    46/55

    Ackno$led&ements:

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

    CD

  • 8/13/2019 sfra article final draft.doc

    47/55

    $"#"$"("S

    +! Bational Research 8ouncil .

  • 8/13/2019 sfra article final draft.doc

    48/55

    Assessent. 8ommittee on 3mprovin& Risk Analysis Approaches 'sed *y the '!S!EPA" Bational Academy Press" 5ashin&ton" #8" 3S9B H=-,-;,-s Er&onomicsRulemakin&! 6ublic Administration Review, 67314 D==-H,

    +;! '!S! Environmental Protection A&ency .+,,@/! Bational Emission Standards for8oke ?ven 9atteries) Final Rule! $ederal Register, 7+37/4

  • 8/13/2019 sfra article final draft.doc

    49/55

    ;,! 9ullard" Ro*ert #! .

    ;D! 8lemen" R!T!

    C+! 8ivic Practices Bet$ork" 9randeis 'niversity .undated/! The Tacoma Smelter andEPA! Accessed at http:$$$!cpn!or&topicsenvironmenttacoma!html

    C;! Bational Research 8ouncil .

  • 8/13/2019 sfra article final draft.doc

    50/55

    CD! Finkel" Adam !" Eldar Shafir" Scott Ferson" 5inston arrin&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 .uman and Social#ynamics of 8han&e competition/!

    CH! Finkel" Adam ! .+,,/! #o Risk Assessors and Re&ulatory Economists Approach'ncertainty And aria*ility #ifferentlyM Presentation at the Society for RiskAnalysis annual meetin&" #ecem*er H" 9altimore" #!

    C=! Evans" V!S!" V!#! raham" !! ray" and R!(! Sielken!

    @C! Bational Research 8ouncil .+,,@/! Risk and Decisions a;out Dis%osal o'ransuranic and 2igh-evel Radioactive

  • 8/13/2019 sfra article final draft.doc

    51/55

  • 8/13/2019 sfra article final draft.doc

    52/55

    H+! 8enters for #isease 8ontrol and Prevention .+,,=/! Beurolo&ic 3llness Associated $ith?ccupational E%posure to the Solvent

  • 8/13/2019 sfra article final draft.doc

    53/55

    F3'RE


Top Related