Nanotechnology Regulation: A Study inClaims MakingTimothy F. Malloy*

UCLA School of Law, UCLA Sustainable Technology and Policy Program, Los Angeles, California 90095, United States

It is generally acknowledged thatnanotechnologyOthe ability tomeasure and to control matter at the

nanoscale levelOis “disruptive,” meaning itis a radical innovation that fundamentallychallenges the existing product/technologymarket and opens new competitiveopportunities.1,2 While such characteriza-tions focus upon its impact on markets, thisnew technology is also disruptive in an-other way; it challenges risk governance inthe United States, meaning the legal and in-stitutional decision-making processes usedin addressing risks facing society.3 Nano-technology raises substantial scientific andpolicy issues regarding both risk assessmentand standard setting, provoking calls forfurther study and “soft law” approaches re-lying upon voluntary action by industryrather than mandatory regulation.4�6 Othercommentators, some invoking the precau-tionary principle, advocate immediate pro-hibition of or substantial limits on nano-technology under existing or new law.7,8

Yet even as the debate over whetherand how to regulate goes on, rapid nano-technology deployment in industrial, com-mercial, and consumer settings continues.The danger of this lag is illustrated by his-torical examples of potentially hazardousinnovations that became entrenched incommerce, ultimately causing substantialadverse health impacts and environmentaldamage, even as regulators engaged in re-

search, contemplation, and voluntary initia-tives. Tetraethyl lead and methyl tert-butylether (MTBE) are just two classic examples,but there are many others.9

The governance challenge with respectto nanomaterials regulation is 2-fold. First,regulatory policy must allow the develop-ment and deployment of this rapidlyemerging technology while minimizing thenegative public health and environmentalimpacts. Second, the difficulties inherent inbalancing market innovation and environ-mental protection even with well-characterized chemicals and technologiesare compounded here because the policymust operate under conditions of greatuncertainty.

There are a variety of potential policytools for tackling this challenge, includingconventional direct regulation, self-regulation, tort liability, financial guarantees,and more. The literature in this area is repletewith proposals embracing one or more ofthese tools, typically using conventionalregulation as a foil in which its inadequacy ispresented as justification for a new proposedapproach. At its core, the existing literatureraises a critical question: What is the most ef-fective role of government as regulator

*Address correspondence tomalloy@law.ucla.edu.

Published online January 25, 2011.10.1021/nn103480e

© 2011 American Chemical Society

Nanotechnology raises

substantial scientific and

policy issues regarding both

risk assessment and standard

setting.

ABSTRACT There appears to be consensus on the notion that the hazards ofnanotechnology are a social problem in need of resolution, but much dispute remains overwhat that resolution should be. There are a variety of potential policy tools for tackling thischallenge, including conventional direct regulation, self-regulation, tort liability, financialguarantees, and more. The literature in this area is replete with proposals embracing one ormore of these tools, typically using conventional regulation as a foil in which its inadequacy ispresented as justification for a new proposed approach. At its core, the existing literature raisesa critical question: What is the most effective role of government as regulator in thesecircumstances? This article explores that question by focusing upon two policy approaches inparticular: conventional regulation and self-regulation, often described as hard law and soft law,respectively. Drawing from the sociology of social problems, the article examines the soft lawconstruction of the nanotechnology problem and the associated solutions, with emphasis on theclaims-making strategies used. In particular, it critically examines the rhetoric and underlyinggrounds for the soft law approach. It also sets out the grounds and framework for an alternativeconstruction and solutionOthe concept of iterative regulation.

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in these circumstances? This article ex-plores that question by focusing upontwo policy approaches in particular:conventional regulation and self-regulation, often described as hard lawand soft law, respectively.

FRAMING THE ISSUESConventional direct regulation, or

“command and control” regulation as itis typically (and often pejoratively)called, can generally be defined as “theissuance of prescriptive rules intendedto directly control the behavior of pri-vate actors.”10 As I discuss more fullylater, the description of direct regula-tion found in the literature is often atodds with its actual structure and opera-tion “on the ground.”

In contrast, self-regulation and softlaw generally refer to governancemechanisms that have no or limited le-gal force.11,12 There is a great deal offuzziness regarding what actuallycounts as self-regulation or soft law,13,14

particularly in the nanomaterials policyliterature. Most commentators wouldcharacterize industry codes of conductsuch as Responsible Care as within theambit of self-regulation.6,11,12 They alsoinclude arrangements in which nongov-ernmental third parties engage with in-dustry in creating voluntary guidelinesor decision frameworks as another ex-tended form of self-regulation. The Envi-ronmental DefenseODuPont NanoPartnership Nano Risk Framework, es-sentially a recommended methodologyfor evaluating and addressing potentialrisks of nanoscale materials, is an ex-ample of this latter form.6

Lastly, some commentators also in-clude “enforced self-regulation” withinthe scope of self-regulation, althoughhere there is some significant ambigu-ity. As originally conceived by Ayres and

Braithwaite in the classic book Respon-sive Regulation, enforced self-regulationwas a form of “contractual” regulation inwhich an individual facility or industrygroup negotiated plant or industry sec-tor specific, legally enforceable ruleswith the regulator.15 Some commenta-tors in nanopolicy appear to take a moreexpansive view, suggesting that “en-forced self-regulation” refers to volun-tary programs in which industry andgovernment actors jointly participate,such as the Environmental ProtectionAgency’s (EPA) ill-fated Nanoscale Ma-terials Partnership Program.6,16

In examining the often competingapproaches of hard law and soft law, Ifocus on how commentators use par-ticular narratives to frame the problemand the potential solutions.17 The policydebate we see occurring now is not sim-ply a rational, analytic enterprise. Soci-ologists and political scientists in par-ticular have examined how socialproblems come to be defined and ad-dressed in policyObe it legislative oradministrative. In one leading thread ofsocial problem theory, sociologists char-acterize policy debate (whether amongacademics in journals such as this one,in the popular media, or in a legislativeor administrative forum) as a “claims-making process.” A claims maker devel-ops narratives aimed at persuading theirrelevant audience (be it peers, the pub-lic, or policymakers) to embrace theirdefinition of the problem and theiridentification and evaluation of the po-tential solutions.18,19

Likewise, political scientists speak ofpolicy entrepreneurs, more intent onadvancing a particular policy than onobjectively evaluating a range of op-tions. In a complex environment inwhich streams of problems, policies,and politics swirl about, policy entrepre-

neurs seek to control the decisionagenda and frame the problem defini-tion so as to advance their favoritepolicy.20,21 Thus, the problem, its de-fined attributes, and the nature of thealternatives are constructions ratherthan objective facts as they are typi-cally presented. They are supported byexpress and tacit assumptions andclaims, both factual and normative. Ex-ploring those assumptions and claims,challenging them, and considering al-ternative claims, can open up the policydiscussion and lead to alternativeconstructions.

Such an analysis thus begins withproblem definition. In the context ofnanopolicy, most articles frame theproblem definition as which gover-nance approach, if any, is best suited tobalance the potential health and envi-ronmental dangers of nanotechnologywith its actual and potential social ben-efits. The articles tend to focus on acommon set of problem attributes withassociated consequences, as describedin Table 1.

Detailed analysis and discussion ofeach of these attributes and their osten-sible consequences are beyond thescope of this paper. However, it is im-portant to note that the attributes andrelated consequences themselves re-flect certain underlying, often tacit as-sumptions about the nature of conven-tional regulation and the capacities ofregulatory agencies. For example, iden-tifying the lack of data about toxicology,metrics, and exposure routes (and theabsence of methodologies for obtain-ing that data in the near term) as an ob-stacle to direct regulation assumes thatsuch regulation is heavily data-dependent and thus ineffective underconditions of uncertainty. As we shallsee, the framing of the problem

TABLE 1. Problem Attributes

problem attribute consequencesexemplar

articles

There is a lack of available methodologies and data regarding uses,hazards, and exposures regarding nanoparticles.

Absent these methodologies and data, conventional directregulation is not feasible.

6, 22, 32

Government agencies have limited technical capacity, knowledge,and resources.

Governance mechanisms must rely upon the capacity, knowledge,and resources of business firms and third-party organizations.

11, 22, 34

Beneficial but potentially risky development and deployment ofnanotechnology is proceeding rapidly.

Balanced implementation of governance mechanisms must occurwith comparable speed.

6, 33, 35

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attributes and consequences also re-

flects certain assumptions about the

incentives and capacities of business

firms. The point here is that these at-

tributes, consequences, and support-

ing assumptions tend to drive the

narrative used by commentators to

advance soft law approaches.

The soft law narrative responds to

the problem attributes by asserting

that business firms, with some support

from nongovernmental organizations

and government, can most effectively

balance the twin concerns of protection

and innovation, at least in the near-to-

medium term. Hard law approaches are

cast as impractical, ineffective, and po-

tentially detrimental to beneficial inno-

vation in nanotechnology applications.

This soft law narrative appears to be

driven by two sets of claims embedded

in the problem attributes and conse-

quences. The first is that, even absent

direct regulation, business firms have

strong incentives and sufficient capac-

ity to adopt safe practices in the use of

nanotechnology in products and pro-

duction processes.22,23 The second is

that direct regulation is substantially

hindered by its inherent structure and

by the limited capacities of the imple-

menting agencies.6,22 Careful unpacking

of those claims reveals that the founda-

tions for the soft law approach are

themselves a bit soft.

BUSINESS INCENTIVES ANDCAPACITIES

With respect to the business narra-tive, I turn first to the incentives thatshape business firm behavior. The litera-ture generally relies upon three behav-ioral influences to support the notionthat industry will effectively regulate it-self: fear of tort liability, fear of technol-ogy stigma, and operation of the “goodneighbor” norm.23,24

Take, for example, the fear of tort li-ability that a company may face whenconsidering whether and how to incor-porate a nanomaterial into a consumerproduct such as a toy, a tie, or a tire.Broadly speaking, should the consumersuffer harm as a result of exposure tothat nanomaterial, the company may beliable for personal injuries and otherdamages under either a negligencestandard or a strict liability standard.Negligence occurs where the companyfailed to act with “due care”; that is, thecompany did not meet the level of careone would expect from a reasonableperson under the circumstances. Strictliability, on the other hand, does not di-rectly depend upon the level of care ex-hibited by the manufacturer. Instead, itapplies where a manufacturer sells aproduct that is unreasonably danger-ous due either to a design or manufac-turing defect or to inadequate warningof dangers associated with theproduct.25,26 These forms of tort liabilityserve a compensatory function; they at-tempt to make the injured party whole.In theory, they also serve a deterrentfunction; the threat of liability drivescompanies to adopt reasonable mea-sures to reduce risks to consumers.27,28

Fear of technology stigma focusesupon the public reaction to revealedhazards rather than technical legal li-abilities. The story here is straightfor-ward; if an accident or other incident in-volving nanomaterials in a consumerproduct or industrial process causes oreven threatens substantial injury ordamage, the resulting backlash coulddevastate not only the involved busi-ness, but the industry sector and per-haps even nanotechnology as a field.Salient examples include the impact ofthe Three Mile Island incident on thenuclear power industry and of the Star-

link incident on genetically modifiedfoods.29,30 In some instances, the reac-tion will be rejection of the technologyby the consumers or public morebroadly; in other cases, the result maybe onerous regulation.

Both fear of tort liability and fear oftechnology stigma relate primarily tothe business firm’s profit-making mo-tive. The third behavioralinfluenceOthe “good neighbor”normsOrelates to social values internal-ized by the firm as an institution, andby its managers and employees as indi-viduals. By good neighbor norms I meana number of social norms and personalvalues that may push members of busi-ness firms and the firms themselves toengage in “other-regarding” behavior.At the corporate level, this is reflected inthe concept of corporate social respon-sibility, the notion that firmsshouldOand in many cases actuallydoOengage in socially responsible be-havior. In other words, firms attempt to“do the right thing.” While some re-searchers link such behavior to instru-mental motives (i.e., good behaviorleads to higher profits), others attributesocially responsible behavior to ethicalor normative drives embedded in firmculture.31 At the individual level, other-regarding behavior such as altruism hasbeen documented by sociologists, psy-chologists, anthropologists, and others,and can be observed in everyday inter-actions.36 Most commentators attributethis behavior to the operation of socialnorms, although there is continued de-bate over whether such norms are ex-ternally enforced through nonlegal so-cial sanctions, self-enforced throughfeeling of guilt or shame, or rather fullyinternalized and thus essentiallyself-executing.37,38

At the outset, we should recognizethat these three incentivesOliability,stigma, and normsOdo appear to havesome role in business firm decision mak-ing. No doubt firms spend money andother resources attempting to avoidproduct liability lawsuits and to avertpublic and government perceptionsthat a product or production process isharmful. With that said, however, thereis ample evidence that these factors areonly part of the story, and in many

The soft law narrative

asserts that business firms,

with some support from

nongovernmental

organizations and

government, can most

effectively balance the twin

concerns of protection and

innovation.

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circumstances are more than overcomeby other individual and organizationaldrives and limitations. In particular,these incentives can lose behavioraltraction in three ways, through what Icall rational slippage, routine slippage,and cognitive slippage.

Rational slippage occurs when thefirm engages in a calculation of the eco-nomic risks and benefits of selling a po-tentially dangerous product, or usingan unreasonably hazardous process. Itcan significantly weaken the impact ofthose incentives, such as fear of liabilityand fear of technology stigma, that playupon a firm’s self-interested profit mo-tive. When the incentives are not prop-erly aligned or structured, the profitsfrom that activity may exceed the firm’sperceived risk of loss.28 For example, inpractice, substantial tort actions basedupon environmental harms and emerg-ing technologies are difficult to win.27,39

One formidable hurdle is that the in-jured party in a tort lawsuit must estab-lish causation, a particularly compli-cated and multifaceted element of thecase. Typically, proving causation wouldrequire demonstrating both that a par-ticular nanomaterial is capable of caus-ing the disease in question (known asgeneral causation) and that exposure tothat material actually caused the in-jured party’s disease in this case (spe-cific causation). This is a difficult enoughstandard to meet in any situation; itcan be insurmountable where there isa long lag between exposure and onsetof disease, a likely scenario with nano-material exposures. This difficulty is alsocompounded by the relative paucity ofdata regarding nanomaterial uses, toxic-ity, and exposure pathways.27,40 It is fur-ther complicated by the so-called Daub-ert standard for the admissibility ofscientific evidence regarding causationin tort cases, a high bar generally requir-ing that the proffered theory or tech-nique have achieved general accep-tance within the relevant scientificcommunity.27,40,41

Rational slippage increases whenone considers what economists call the“agency problem.” A business firm is auseful fiction but, in reality, individualexecutives and managers are the actualdecision makers, acting as agents for

the firm. In theory, they should be mak-ing decisions that are in the best inter-ests of the firm. In practice, their ownimmediate interest in maximizing sal-ary, bonuses, and status often leads todecisions that enhance short-term per-formance of the business, while under-mining the long-term success or evensurvival of the firm.42 This phenomenonis particularly acute where the action inquestion gives rise to immediate corpo-rate profit coupled with potentially dev-astating but long-delayed conse-quences, as in tort claims involving dis-eases with long latency periods.

All of this is not to say that potentialtort liability has no influence upon busi-ness behavior. Clearly, it has some influ-ence; one need only observe the preva-lence of insurance markets and theexistence of risk-management depart-ments and professionals within businessfirms to recognize that firms respondto the tort regime in structuring their or-ganizations and operations. But the cen-tral questions are how strong an influ-ence tort liability is, and what behaviorit spawns. For example, concern overtort liability could drive an organizationto make safer products, just as propo-nents of soft regulation contend. Alter-natively, the specter of liability may alsolead to strategic defensive responses,such as the underproduction of infor-mation regarding hazards or the con-scious squelching of safer but morecostly alternatives so as to underminethe viability of potential future tortclaims.28,43 When one takes into ac-count the substantial legal and eviden-tiary hurdles facing the injured party,adds the high transactions costs associ-ated with such lawsuits, and layers ontop the likelihood of strategic behavior,“nano-tort” liability is not a particularlystrong incentive for safe behavior.

Routine slippage focuses upon howthe structural and organizational fea-tures of a business firm itself can under-mine the effectiveness of incentives. Ex-cept for the very smallest of businesses,a company is a network of participants,with each performing assigned tasks ina coordinated effort to produce a prod-uct or service effectively and efficiently.Within that organizational network, re-sources such as funding and authority

are allocated through a variety of inter-nal rules, procedures, and practices.Likewise, the network participants aresupplied with the information neededto perform their tasks through a varietyof formal and informal communicationchannels.44

Whether a company is driven byprofit maximization or social responsi-bility or both, the capacity of managersand staff to act in accordance with thosegoals is dependent upon their accessto the necessary information, authority,and funding. For example, a product de-signer with a sincere desire to protectthe consumer will not avoid a poten-tially hazardous component unless heis aware of that hazard and has the au-thority to alter the product specifica-tions. Likewise, a trustworthy, economi-cally rational executive will likely chooseinvestment in an ostensibly cheaper, es-tablished production process over fund-ing an apparently more expensive, saferalternative where the potential tort li-ability costs of the former have not beenincorporated into the financial esti-mates. For a variety of reasons de-scribed in extensive literatures in law,sociology, economics, and businessmanagement, the flow of authority,funding, and information in many com-panies prevents optimal protection ofpublic health and the environment.44

This can be so even in those firms that,whether based on economic rationalityor on other-regarding norms, are sin-cerely committed to reducing the im-pacts of their operations.

Cognitive slippage acknowledgeshumans’ remarkable facility to “workaround” even strongly held normativebeliefs when it suits their self-interest.One such cognitive strategy is normneutralization, in which the individualuses cognitive scripts to justify waywardbehaviorOa handy list of excuses forsituations in which the relevant normhas been activated.45 An example is the“metaphor of the ledger” script, inwhich the individual justifies an immi-nent norm violation by balancing itagainst a prior history of compliant be-havior, characterizing him or herself asan essentially “good” person doing theirbest.46 Defensive denial is another com-mon cognitive strategy that works not

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by justifying an acknowledged norm

violation, but rather by recharacterizing

the situation so as to deny that the rel-

evant norm is even applicable.47,48 For

example, one empirical study demon-

strated that when conserving energy

would impose high personal costs on

individuals, they avoided the conserva-

tion norms by adjusting their percep-

tions of the seriousness of energy short-

ages or the harms flowing from current

levels of energy use.47

The demonstrated effects of calcu-

lated, routine, and cognitive slippage

thus undermine the soft law narrative’s

reliance on tort liability, technology

stigma, and other-regarding norms as

incentives for effective self-regulation.

Yet even when such incentives do play

a strong part in business decision mak-

ing, there is good reason to question

the capacity of businesses to engage in

effective self-regulation. Recall that as

part of problem definition, the soft law

literature tends to characterize busi-

nesses as agile innovators, responding

efficiently to dynamic conditions. While

that may be true for certain firms, busi-

ness management researchers have

identified the opposite effect in a vari-

ety of studies, concluding that many

otherwise successful business organiza-

tions exhibit the inability to translate

valuable new knowledge into effective

action. This effectOcalled the perfor-

mance paradoxOis one manifestation

of the wider phenomenon of organiza-tional inertia, defined as the strong per-sistence of existing form andfunction.44,49 No doubt the strength ofinertial forces will vary across individualfirms and industry sectors, but as a gen-eral matter, many organizations resistchanging their internal processes andcore functions.44,50 While this inertia as-sures stability and reliable performanceover shifting conditions, in some cases,conditions change in ways that renderthe firm’s standard behavior inefficientor socially detrimental.51

Even assuming that a particular firmis operationally nimble, that trait alone isnot sufficient to conclude that the firm isbest left to its own devices in respondingto the challenges of nanotechnologymanagement. The firm will also need therequisite information regarding the haz-ards of that technology and the technicalskills to select and to implement an effec-tive response. Here, the heroic image ofthe environmentally conscious firm act-ing swiftly on the basis of its deep knowl-edge of its own operations breaks down.For example, while companies obviouslyunderstand their processes and theneeds of the market, they often lack suffi-cient information regarding the chemi-cals and (sometimes ill-defined) materi-als they use in those processes toadequately protect their own employ-ees. Likewise, extensive experience in aparticular industrial process does not en-sure knowledge about the nature orproper management of emissions orwastes from that process.19,52

Recent surveys of companies pro-ducing and using nanomaterials pro-vide troubling evidence that suchknowledge gaps are an impediment toeffective management ofnanomaterials.53�55 Third parties suchas trade associations can help to miti-gate the problem by coordinating thecollection and dissemination of infor-mation across the relevant industry sec-tor. But dynamics in the business envi-ronment raise meaningful concernsabout the completeness and accuracyof the information developed by tradeassociations. They are not simply neutralcoordinators, but instead are strategicactors who may have incentives to with-hold information, or to skew it so as to

reduce costs to the industry or to ben-efit players within the industry havingdisproportionate influence over the as-sociation.19

RECASTING REGULATION AND THEREGULATORS

Turning now to the regulatory sideof the story, we see that the soft law’snarrative here is likewise flawed, bothwith respect to the nature of directregulation and the capacity of regula-tory agencies. Conventional direct regu-lation is typically depicted as a rigid,top down, one-size-fits-all approach. Inparticular, soft law advocates tell a storyof regulation in which agencies estab-lish prescriptive exposure limits basedupon extensive toxicological and expo-sure data. According to the soft law nar-rative, it is this data-intensive approachthat prevents the effective applicationof direct regulation in the data-poor en-vironment of nanotechnology policy.This narrative mischaracterizes conven-tional regulation in two important ways.

First, while it is true that some regu-latory programs rely heavily upon toxi-cological and exposure data to triggerregulatory action or set acceptable ex-posure levels, it is also true that manydo not. In the United States, health stan-dards under the Occupational Healthand Safety Act (OSHA) are an exampleof the former, whereas emission stan-dards under the Clean Air Act (CAA) andmanagement standards in the federalhazardous waste programs are ex-amples of the latter. Indeed, severalCAA programs eschew risk assessmentaltogether and instead develop emis-sions limits on the basis of the best prac-tices used within the relevant industrysector. The limits are almost uniformlywritten as performance standards,meaning that individual facilities arefree to select the means of attaining thestandard. Moreover, standard settingtakes into account differences amongfirms within the relevant sector bybreaking the sector down into catego-ries and subcategories based uponcompany size, type of process, andother relevant factors, andOto the ex-tent appropriateOsetting differentemission limits for the categories andsubcategories.19

The demonstrated effects

of calculated, routine, and

cognitive slippage thus

undermine the soft law

narrative’s reliance on tort

liability, technology stigma,

and other-regarding norms

as incentives for effective

self-regulation.

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Second, although conventionalregulation often does involve standardsetting (whether technology-based orrisk-based), it is substantially broaderthan the narrow soft law narrativesuggests. Two other types of directregulation commonly used in existingprograms are information-based regula-tion and management-based regula-tion. Information-based regulation is in-tended to address situations in whichthe regulated firm has information re-garding its operations not otherwiseavailable to the government or somerelevant third party. Thus, under thehazardous waste regulations, genera-tors of hazardous waste must reportdata regarding waste generation anddisposal to the government. Likewiseunder OSHA, manufacturers of hazard-ous chemicals must provide specifiedinformation to downstream commer-cial users. Management-based regula-tion requires companies to develop andto implement facility plans and proce-dures for evaluating and addressingvarious hazards.56 For example, as partof the Risk Management Program estab-lished under the CAA, the EPA requirescertain firms to prepare and to imple-ment risk-management plans, includinga specific obligation to develop appro-priate management systems.57,58 As dis-cussed below, each of these types of di-rect regulation can play an important,immediate role in nanotechnologyregulation.

Pessimism about the capacity ofgovernment as a regulator dissipateswhen the role of the government isclarified. Clearly, there are substantialtroubling questions regarding the ca-pacity of government to “micro-manage” individual facility operations,particularly under the conditions of un-certainty surrounding nanotechnology.However, regulators are particularly wellsuited to engage in the actual type ofregulatory activity typically taken: thenuanced codification of best practicesand the implementation of information-based and management-based pro-grams. For example, using broadinformation-collection authority arisingfrom the CAA, the EPA gained extensiveexperience in collecting and disseminat-ing data regarding best practices in

terms of engineering and manage-

ment. In doing so, it leverages the ca-

pacities of the trade associations as par-

ticipants in the design and

implementation of those collection ac-

tivities. Unlike informal efforts of trade

associations and research institutions,

this formal authority reaches all mem-

bers of the relevant industry and pro-

vides sanctions for recalcitrant or deceit-

ful facilities.19

Where adequately funded, a govern-

ment agency can also serve as a rela-

tively neutral referee, providing coordi-

nation and direction when

management practices across an indus-

try sector conflict. Through its standard-

setting process in the CAA, EPA served

this role in the context of a mandatory

rulemaking process. (The National Insti-

tute for Occupational Safety and

Health’s nanotechnology activities

through the Nanotechnology Research

Center is a particularly salient example

of this coordination and guidance role

in the nanotechnology context, albeit as

part of a nonregulatory voluntary pro-

gram.59) The public nature of the CAA

rulemaking process, which invites par-

ticipation from a broad range of inter-

ested parties, coupled with the right of

judicial review, provides a level of ac-

countability, legitimacy, and transpar-ency not evident in voluntary soft lawapproaches.19 These features are en-hanced by the regulatory agency’s ca-pacity to ensure quality control throughcompliance assistance and enforce-ment, assuming the agency is providedsufficient resources.

CONCLUSIONS AND PROSPECTSThe above discussion challenged

the soft law narrative regarding busi-nesses incentives and capabilities, andconcerning the structure of direct regu-lation and the capacities of the regula-tory agencies. It offers a different story,one which is skeptical of the role thatnormative and economic incentivesplay in securing safe business behavior,and more optimistic about the ability ofgovernment to regulate successfully.But what would be the nature andscope of a nanotechnology regulatoryregime that embraces that alternativestory? While extensive discussion is be-yond the scope of this article, it is usefulto sketch out the potential frameworkfor an alternative iterative approach toregulation.

Iterative regulation is based on twoorganizing principles. First, where rea-sonable concerns are raised about ananomaterial in the scientific literature,regulators should make reasonable ef-forts to minimize potential hazards inthe near term.60 Although existing infor-mation gaps largely preclude the set-ting of quantitative technology-basedor health-based exposure limits, a vari-ety of qualitative best practices for man-aging nanotechnology do exist. Ex-amples of such practices range fromthe streamlined approaches to riskevaluation such as control banding, toguidelines for the selection and use ofspecific engineering controls and workpractices.59,61 It is unlikely that thosebest practices will diffuse broadly andconsistently throughout the relevant in-dustry sectors absent government inter-vention in the form of direct regula-tion. Thus, regulators should deploy thefull suite of direct policy tools in pro-moting the diffusion and effectiveimplementation of best practices, in-cluding information disclosure andmanagement-based regulation. Thus,

Governmental regulators

are particularly well suited

to engage in the actual type

of regulatory activity

typically taken: the nuanced

codification of best

practices and the

implementation of

information-based and

management-based

programs.

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agencies would use existing or newlygranted information-based regulationto identify a range of best practices, andmandate that individual firms evaluate,select, and implement best practicesmost suitable to their operations.

Second, the nature, scope, and rigorof the regulatory action should adjustover time to reflect improvements anddevelopments in data availability andscientific methodologies. So, for ex-ample, as toxicity testing and risk-evaluation methods progress, regula-tors may move from qualitative bestpractices to quantitative exposure lim-its. Alternatively, efforts are currentlyunderway to develop methods for sys-tematically identifying and evaluatingsafer alternative materials and pro-cesses. The National Institute for Occu-pational Safety and Health’s Preventionthrough Design (PtD) initiative is one ex-ample of this approach, which seeks toanticipate and to “design-out” potentialhazards in products and processes.62

Other researchers are developing for-mal decision-analysis tools such as mul-ticriteria decision analysis methods toassist in comparing alternatives.16 Suchmethodologies may eventually enableregulators to shift from a conventionalrisk-management approach focused onsetting acceptable levels to a compara-tive approach seeking the safest viablealternative. The promise of such futureregulatory developments, however,need not and should not hinder theuse of currently available conventionalapproaches in the interim.

Acknowledgment. I am grateful to KathyrnLeonard for excellent research assistance andto the organizers and participants of the thirdNanotechnology and Society Workshop heldat the University of Massachusetts, Amherst. Iwould also like to acknowledge support fromthe Center for Environmental Implications ofNanotechnology at UCLA which is funded bythe US National Science Foundation and theEnvironmental Protection Agency under Co-operative Agreement Number EF 0830117.Any opinions, conclusions or recommenda-tions expressed in this article are those of theauthor and do not necessarily reflect the viewsof the National Science Foundation.

REFERENCES AND NOTES1. Strategy for Nanotechnology-Related

Environmental, Health and Safety RelatedResearch; National Science andTechnology Council: Washington, DC,2008.

2. Walsh, S. T. Roadmapping a DisruptiveTechnology: A Case Study: TheEmerging Microsystems and Top-DownNanosystems Industry. Technol. ForecastSoc. Change 2004, 71, 161–185.

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