Managing the Effects of NANOTECHNOLOGY - Wilson Center

Managing the Effects NANOTECHNOLOGYof

Project on EmergingNanotechnologies

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J. Clarence Davies One Woodrow Wilson Plaza1300 Pennsylvania Ave., N.W.Washington, DC 20004-3027

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Project on Emerging Nanotechnologies

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The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in April 2005 by the WilsonCenter and The Pew Charitable Trusts. It is dedicated to helping business, governments, andthe public anticipate and manage the possible human and environmental implications ofnanotechnology.

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CONT

ENTS

Preface

Executive Summary

About the Author

Characteristics of Nanotechnology1. Defining NT2. Rapid Development3. Lack of Effects Data

Existing Regulatory Authorities1. Toxic Substances Control Act (TSCA)2. Occupational Safety and Health Act (OSHAct)3. Food, Drug, and Cosmetic Act (FDCA)4. Environmental Laws – CAA, CWA, RCRA5. Other Laws

Applying Existing Authorities1. Coordinating Mechanisms2. Amending Existing Laws 3. Strengthening Existing Laws

A New Law 1. Description2. Advantages and Disadvantages3. Other Options

Incentives for Environmentally Beneficial Technology1. Research 2. Tax Breaks3. Acquisition Programs4. Regulatory Advantages

New Institutional Capabilities 1. International Harmonization2. Foresight capability3. Research4. Public Participation

Bibliography

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J. Clarence Davies Senior Advisor, Project on Emerging Nanotechnologies

and Senior Fellow, Resources for the Future

The opinions expressed in this report are those of the author and do not necessarily reflectviews of the Woodrow Wilson International Center for Scholars or The Pew Charitable Trusts.


This paper has two purposes.The first is to describe the menu of possibilities for governmentaction to deal with the adverse effects of nanotechnology (NT). If there are important alter-natives that are not described here it is because of inadvertence or ignorance.

The second purpose is to provide evidence relevant for determining what needs to bedone to manage NT.When I began this work, my initial assumption was that there was noneed for new statutory authority. As I learned more about the unique aspects of NT andthought more about the weaknesses of existing statutes, I was increasingly led to the conclu-sion that a new law is needed.This paper, however, is not an advocacy piece for a new law. Itwould have been written quite differently if that were its purpose. Rather, it is a policy analy-sis, intended to give the reader the information relevant for thinking about a course of action.In short, the paper is intended to inform, not persuade.

A word needs to be said about the paper’s title. In the coming decades, NT is likely tochange many aspects of our lives, hopefully for the better. New materials and products willrevolutionize the way we do many things. I do not address these kinds of effects.The timeframe of the paper is the next five-to-ten years, and the primary focus is on managing poten-tial adverse effects of NT.

I am grateful to the Project on Emerging Nanotechnologies for its generous support andencouragement, and also to Resources for the Future for its continuing support.A number ofindividuals have been generous in giving their time to read the paper and answer stupid ques-tions from the author. I am particularly grateful to Julia Moore, who initiated this project, andto Dave Rejeski, Andrew Maynard, Barbara Karn and Evan Michelson, all of the WilsonCenter.Among others who gave generously of their time were William K. Reilly, Mike Taylor,Mark Greenwood and Michael Rodemeyer. Jeff Porro did an excellent job editing the man-uscript.The input of all these people has greatly improved this paper, but all responsibility forwhat it contains remains solely with the author.

Preface

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Nanotechnology (NT) is the production and use of materials at the smallest possible scale—100 nanometers or less. One hundred nanometers is approximately 1/800th the width of ahuman hair and 1/70th the diameter of a red blood cell. Materials at the nanoscale oftenexhibit very different physical, chemical, and biological properties than their normal sizecounterparts. While we know little about possible adverse effects of nanotechnology, weknow enough to recognize that there needs to be some type of governmental oversight toensure that public health and safety are not adversely affected.This paper reviews the optionscurrently available to provide oversight, looking at the entire suite of federal government reg-ulations, and concludes that:

Nanotechnology is difficult to address using existing regulations. There are a number ofexisting laws—notably the Toxic Substances Control Act; the Occupational Safety andHealth Act; the Food, Drug and Cosmetic Act; and the major environmental laws (Clean AirAct, Clean Water Act, and Resource Conservation and Recovery Act)—that provide somelegal basis for reviewing and regulating NT materials. However, all of these laws either suf-fer from major shortcomings of legal authority, or from a gross lack of resources, or both.They provide a very weak basis for identifying and protecting the public from potential risk,especially as nanotechnologies become more complex in structure and function and theapplications become more diverse.

A new law may be required to manage potential risks of nanotechnology. The law wouldrequire manufacturers to submit a sustainability plan which would show that the product willnot present an unacceptable risk, a term that is further discussed in the paper. The politicalobstacles to passing new legislation are very large, though not impossible, and the drawbacksof trying to fit NT under existing laws make the attempt worthwhile.

New mechanisms and institutional capabilities are needed. The paper describes severalmechanisms to encourage beneficial applications of NT.These include research, tax breaks,acquisition programs, and regulatory incentives. It then outlines institutional needs in fourareas: international harmonization, foresight capability, research on adverse health and envi-ronmental effects, and public participation.

If nothing specific is done to manage nanotechnology’s possible adverse effects, a range ofundesirable developments could emerge.The public potentially would be left unprotected,the government would struggle to apply existing laws to a technology for which they werenot designed, and industry would be exposed to the possibility of public backlash, loss ofmarkets, and potential financial liabilities.The challenges presented by nanotechnology are asmany and varied as the promises that NT holds for a better life. If nanotechnology is to ful-fill its promise, society must openly face the issues of whether the technology has or couldhave adverse effects, what these effects are, and how to prevent them in the future.

Executive Summary

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J. Clarence (Terry) Davies

Dr. Davies, a senior advisor to the Project on Emerging Nanotechnologies and a senior fel-low at Resources for the Future, is one of the foremost authorities on environmental researchand policy. He helped pioneer the related fields of risk assessment, risk management, and riskcommunication, and his work has advanced our understanding of cross-media pollution, thetendency of pollutants to move across boundaries, from air to water to land, revealing short-comings in the legal and regulatory framework.

Davies served during the first Bush Administration as Assistant Administrator for Policy,Planning and Evaluation at the U.S. Environmental Protection Agency (EPA). Earlier, he wasthe first examiner for environmental programs at the Bureau of the Budget (now the Officeof Management and Budget). In 1970, as a consultant to the President’s Advisory Council onExecutive Organization, he co-authored the plan that created EPA. Dr. Davies also wasExecutive Vice President of The Conservation Foundation, a non-profit think tank on envi-ronmental policy; Executive Director of the National Commission on the Environment; anda senior staff member at the Council on Environmental Quality, where among other activi-ties, he wrote the original version of what became the Toxic Substances Control Act. He hasserved on a number of committees of the National Research Council, chaired the Council’sCommittee on Decision Making for Regulating Chemicals in the Environment, chaired theEPA Administrator’s Advisory Committee on Toxic Substances, and served on EPA’s ScienceAdvisory Board. In 2000, he was elected a Fellow of the American Association for theAdvancement of Science (AAAS) for his contributions to the use of science and analysis inenvironmental policy.

Davies is the author of The Politics of Pollution, Neighborhood Groups and Urban Renewal,Pollution Control in the United States, and several other books and monographs addressing envi-ronmental policy issues. A political scientist by training, Davies received his B.A. inAmerican government from Dartmouth College, and his Ph.D. in American governmentfrom Columbia University. He taught at Princeton University and Bowdoin College, andhas helped mentor a generation of environmental policy researchers.

About the Author

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7Managing the Effects of Nanotechnology

Nanotechnology (NT) is the production anduse of materials with purposely engineeredfeatures close to the atomic or molecular scale.NT deals with putting things together atom-by-atom and with structures so small they areinvisible to the naked eye. It provides the abil-ity to create materials,devices and systems withfundamentally new functions and properties.

The promise of NT is enormous. It hasimplications for almost every type of manufac-turing process and product. Potential NTapplications in the next few decades could pro-duce huge increases in computer speed andstorage capacity, therapies for several differenttypes of cancer, much more efficient lightingand battery storage, a major reduction in thecost of desalinating water, clothes that neverstain and glass that never needs cleaning.Whilethe benefits are almost limitless, they will berealized only if the potential adverse effects ofNT are examined and managed.

NT is new,but the effort to understand andmanage its effects will be long-term. As theworld community tries to reduce the adverseeffects of the technology, our understanding ofthese effects will steadily increase.At the sametime, as the technology advances and commer-cial applications multiply, new challenges andproblems will arise.The topics covered in thispaper will be with us for decades.

Three aspects of the technology are relevantto questions of how to manage it.The first is itsdefinition. NT covers a wide variety ofprocesses and materials. One must considerwhether it makes any more sense to talk aboutregulating or managing NT than it does to talkabout regulating or managing things that areblue or things that are very large.The second isthe rapid development of the technology. It hasquickly found new applications and it willcontinue to expand into new materials and

new uses. The third is NT’s possible adverseeffects. Right now, we know very little aboutthese effects.

1. Defining NTThe definition of NT is subject to some con-fusion and controversy, and is complicated bythe fact that there are naturally occurringnano-size materials and other nano-size parti-cles that occur as byproducts of combustion orindustrial processes. Size is critical in any defi-nition of NT, but there are a variety of defini-tions in circulation. Some of the differencesover definition are of only academic interest,but the way NT is defined in a regulatory con-text can make a significant difference in whatis regulated, how it is regulated, and how wella regulatory program works.

The U.S. National NanotechnologyInitiative (NNI) defines NT as “the under-standing and control of matter at dimensions ofroughly 1 to 100 nanometers … nanotechnol-ogy involves imaging, measuring, modeling,and manipulating matter at this length scale”(www.nano.gov accessed 10/6/05). TheEuropeans tend to define it more simply as thetechnology dealing with applications andproducts with engineered structures smallerthan 100 nanometers (Swiss RE 2004 p.11;The Royal Society 2004,p.5).For comparison,a single human hair is approximately 80,000nanometers wide, and a red blood cell isapproximately 7,000 nanometers wide (RoyalSociety 2004, p. 5).

In the context of this paper, the question ofdefinition raises at least two important furtherquestions: 1) Does it make sense to regulate ormanage a collection of processes or materialson size alone? 2) Can a definition be formulat-ed that allows both manufacturers and regula-tors to know what is included and what is not?

Characteristics of Nanotechnology

The basic reason that it makes sense toregulate NT as a separate category is that NTmaterials behave differently from convention-al materials. The properties of NT materialsare often not predictable from the laws ofclassical physics and chemistry. The laws ofelectricity that apply to bigger things may nothold for NT materials. A material that con-ducts electricity at normal size may be anelectrical insulator at NT size, and vice versa.We do not know enough about the toxicityand environmental effects to know whetherNT materials are also different in theserespects, but it is likely, for example, that thetoxicity of NT materials is more related totheir surface area than to their weight(Oberdorster 2005, Maynard 2005). Certainlythe direct relationship between volume ofmaterial and exposure—assumed in mostchemical regulation—is not a useful guidefor dealing with NT.

Another factor that differentiates NTmaterials is the importance of structure indetermining their physical and biologicalbehavior. Some experts prefer to talk about“nanostructured materials” rather than nano-materials. In many cases, NT products startwith some molecule or atom—carbon, titani-um or gold, for example—shaped into a basicform such as a nanodot or nanotube. Theseforms are then combined into larger struc-tures, and/or combined with other materialsuch as textile, resin or glass.The behavior ofthe NT product cannot be predicted from thestarting chemical, or often even from the basicNT form, because the structure of the mate-rial will be a major determinant. In thisrespect, chemical polymers are similar and,interestingly, the Toxic Substances Control Act(see section II) exempts polymers.

Given the above differences, the existingregulatory and management programs are notlikely to be very useful in dealing with NT.

This does not necessarily mean that existingstatutes cannot be used, but, at a minimum,they will require adjustment and adaptation.Sections II and III of this paper discuss theapplication of existing authorities to NT.

When discussing the management of NTas a separate category, it may be useful to dis-tinguish between NT processes and NTmaterials. The latter almost certainly willrequire basic changes in government regula-tory programs. NT processes, on the otherhand, may be more amenable to regulationunder the Occupational Safety and HealthAct (OSHAct) and existing environmentallaws. Section II discusses this in more detail.

The answer to the definitional question—whether regulators and those regulated willbe able to make a clear demarcation betweenwhat is and what isn’t considered NT—willdepend on the details of the definition andthe technical capability for applying it.Theseissues cannot be resolved at the present time,but it is relevant that manufacturers acrossvarious industries seem to be in generalagreement about what is considered NT.

2. Rapid DevelopmentThe current age is characterized by accelerat-ing technological development, and NT isdeveloping extraordinarily rapidly. The fieldwas not identified until 1959, when Nobelphysicist Richard Feynman called attention tothe opportunities in the realm of the “stagger-ingly small” (Ratner and Ratner 2002, p.38).In 2001, Science magazine named NT the“breakthrough of the year.” Currently, thereare several hundred different commercialapplications of NT. The National ScienceFoundation predicts that nano-related goodsand services could be a $1 trillion market by2015. (Roco and Bainbridge 2001, p.3. Thisoften-repeated figure seems to have little ana-lytical basis. See Miller et al 2005, p.175.)

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Because of the ongoing speed of NTdevelopment, regulatory or other delayscaused by government will be costly to theindustry and could be deadly to small firmswith little start-up capital. Government maytry to avoid giving unfair advantage to anyone firm or industry segment, but it will beimpossible to maintain a “level playing field.”Regulation inevitably will benefit somefirms at the expense of others. Larger firmswill have an advantage over smaller firms.Firms dependent on rapid introduction of aproduct will be disadvantaged in relation tothose that are not so dependent.

The rapid development of NT also meansthat government managers always will beoperating with outdated information, andthat data about NT effects will lag behindcommercial applications. Priorities forresearch and for regulation will need to shiftconstantly. We have moved into a worldwhich is, as David Rejeski states, “dominat-ed by rapid improvements in products,processes, and organizations, all moving atrates that exceed the ability of our tradition-al governing institutions to adapt or shapeoutcomes.” He warns,“If you think that anyexisting regulatory framework can keep pacewith this rate of change, think again”(Rejeski 2004, p.45.).

These consequences do not mean thatgovernment should not deal with theadverse effects of NT. Such difficulties needto be recognized and taken into accountwhen designing and implementing an NTmanagement system.

3. Lack of Effects DataGiven how little time has elapsed since theinception of NT, the lack of knowledgeabout its adverse effects is not surprising.Thetotal number of research studies dealing withadverse effects of NT is small, but growing.

(Summaries include: Maynard 2005,Oberdorster 2005, and Thomas 2005.)

Concerns about NT’s potential adverseeffects relate to both exposure and toxicity.The very small size of nano-structured parti-cles poses unique problems of exposure. NTparticles potentially can penetrate deep intothe lungs when inhaled, may be absorbedthrough the skin, and may be circulatedthroughout the entire human body oncethey get into any single part of the body.Oberdorster et al (2005) note,“The biologicactivity and biokinetics [of nanoscale parti-cles] are dependent on many parameters: size,shape, chemistry, crystallinity, surface proper-ties (area, porosity, charge, surface modifica-tions, weathering of coating), agglomerationstate, biopersistence, and dose.” Once NTmaterials get into the ambient environment,it may be impossible to contain them. Theconcerns about exposure are not theoretical.Many of the current commercial applicationsof NT are high-exposure uses such as cos-metics, clothing and drugs.

The toxicity aspects of NT are just begin-ning to be explored. Maynard (2004) statesthat,“there are a number of quantitative indi-cators that nanostructured materials maypresent unique health risks.” Particle surfacearea and activity may be better indicators ofthe pulmonary toxicity of nanoparticles thanmass and bulk chemistry (ibid.).Nanoparticles may be transported from thenasal region to the brain via nerve endings(Oberdorster 2005). Carbon nanotubes maylead to significant inflammation in the lungs(Maynard 2005). A few tests on fish haveshown toxic, but not lethal, effects(Oberdorster 2005).This and other fragmen-tary knowledge we have of the adverseeffects of NT is clearly rudimentary, but it isenough to show that there are potential oractual effects that warrant concern.


In the U.S. political system, it has never beeneasy to pass new laws regulating commercialproducts (Lazarus 2004). In the current politi-cal climate, it is close to impossible.Thus, thosewho see a need to address the health and envi-ronmental effects of NT have focused theirattention on existing regulatory authorities.These authorities are examined below. Foreach of the major laws, I look at the extent towhich that law can be applied to NT, and atthe strengths and weaknesses of the regulatoryregime if it were applied.

It is important to keep in mind that ade-quate legal authority is not the only require-ment for a successful regulatory program.Adequate resources of personnel and moneyand the will to use the resources and authorityalso are necessary. Many of the programs dis-cussed below do not have the resources neces-sary to fulfill their legal obligations. I will notesome particularly egregious examples in thediscussion of individual programs.

1. Toxic Substances Control Act(TSCA)President Nixon’s Council on EnvironmentalQuality originally proposed TSCA as a way ofdealing with numerous fears—founded andunfounded—related to toxic chemicals.Enacted in 1976, its primary goals were to pre-vent new chemicals from being marketedwithout adequate safeguards, and to fill gaps inthe regulation of existing chemicals. The lawwas passed with lukewarm support by aDemocratic Congress.

TSCA’s coverage is quite broad, with theresult that it is considered the primary vehiclefor regulating NT. A broad coalition of envi-ronmental groups, including the NaturalResources Defense Council and Greenpeace,has called for regulating NT under the provi-

sions of TSCA (comments from NRDC et alin EPA Docket OPPT-2004-0122, submittedJune 9, 2005).

TSCA’s coverage is broad in at least tworespects. First, unlike most of the environmen-tal statutes, it is not limited to covering onepart of the environment (air, water, etc.).Thus,its regulatory reach encompasses all potentialadverse effects—not just those occurring insome particular medium. This is appropriatefor NT materials and products, the effects ofwhich are not likely to be limited to a partic-ular part of the environment.

Second, the law is directed at “chemicalsubstances and mixtures” broadly defined as“any organic or inorganic substance of a par-ticular molecular identity” (TSCA sec.3(2)(A)).Types of products specifically coveredby other statutes—such as pesticides, drugs,cosmetics, and medical devices—are excludedfrom TSCA’s coverage. The environmentalcoalition cited above asserts that “all engi-neered nanomaterials are ‘new chemical sub-stances’ under TSCA” and should be regulatedas such (comments, p.2).

Even if NT materials do not meet theTSCA criterion for being new chemicals,there is another provision of the act that couldbring them under its regulatory umbrella.Thisis the provision for “significant new use” rules(SNURs). To simplify somewhat, the EPAAdministrator can declare that an existingchemical be regulated as if it were a newchemical if it is put to uses that might changeits effects, for example, by increasing humanexposure (TSCA sec. 5(a)).The new use provi-sions would not be a feasible method of regu-lating NT if each particular nanomaterial hadto be subject to a SNUR because thatapproach would require an unrealistically largeamount of time and resources.However,TSCA

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Existing Regulatory Authorities

(sec. 26(c)) provides that any action that can betaken with respect to individual chemicals alsocan be taken with respect to “categories” ofchemicals. Categories are defined to include agroup of chemicals that are similar in “physicalproperties” (sec. 26(c)(2)(A)), a definition thatwould seem adequate to cover NT materialsbecause NT materials share similar physicalproperties, such as size.

Perhaps the most challenging problemraised by trying to include NT materialsunder TSCA is the importance of structurediscussed in Section I-1 above. Even assumingthat NT materials are within TSCA’s jurisdic-tion at the stage when a chemical is shapedinto a basic NT form (e.g., nanodot, nan-otube), the exposure and toxicity from theultimate product cannot be predicted at thatpoint. Thus, efforts to deal with the adverseeffects of NT must focus on the stage of theultimate product. However, it may be unrea-sonable and impractical to expect the manu-facturers of basic NT forms to keep track ofall possible uses. Furthermore, by the nextstage in the process when the NT material iscombined into larger structures and/or othermaterials, it may have lost the molecular iden-tity that defines what TSCA covers. Labelingon the basic NT form that requires reportingof uses—as well as tracking of the NT supplychain—may provide a partial solution to thisdifficulty. But this is a clear example of theproblems that arise when trying to applyexisting legal categories to NT products.

Currently,TSCA’s new chemical notifica-tion requirements exempt several categoriesof chemicals. The law (sec. 5(h)) authorizesthe EPA Administrator to make exemptions,but what is exempted is defined by rulespromulgated by the Administrator. Theexemption most relevant to NT exemptschemicals produced in volumes of 10,000kilograms or less per year (Code of Federal

Regulations,Title 40, Ch.1, part 723.5).Thisis equivalent to anything less than about 11tons a year, and would exclude almost all NTproducts. It clearly does not make sense ifTSCA is to be applied to NT. EPA wouldneed to amend the low-volume exemption toexclude NT materials, but crafting the exclu-sion would be challenging.

TSCA is a law with dramatic strengths andweaknesses. Its strengths are the flexiblebroadness of its coverage (see above) and thewide range of measures it allows to be takento deal with chemical risks (TSCA sec. 6).Themeasures include almost any conceivablerequirement the EPA Administrator wouldwant to impose.

TSCA’s strengths are, not coincidentally,balanced by hedges and obstacles that make itdifficult for EPA to take action.The entire lawis premised on the balancing of risks and ben-efits (see especially TSCA 6(c)(1)). Such bal-ancing invites controversy and litigation. Theact stacks the deck against EPA in litigation inat least three important ways.

First, the technical standard of judicialreview in the act is: “supported by substantialevidence in the rulemaking record” (TSCA19(c)(B)(i)). This standard is very difficult tomeet, and it contrasts with the much easier“arbitrary and capricious” standard applied tothe Clean Air Act, Clean Water Act and mostother environmental statutes (see CorrosionProof Fittings v. EPA, 947 F.2d 1201, para.15).The result is that it is very difficult for EPA todefend rules promulgated under TSCA.

A second weakness is that TSCA implicit-ly assumes that no knowledge about a chem-ical means that there is no risk.The most rel-evant section (5(e)) is the epitome of a “Catch22.” It states that if EPA does not have enoughinformation “to permit a reasoned evaluationof the health and environmental effects of achemical,” it can delay or prohibit its manu-


facture only if it can show that the chemical“may present an unreasonable risk”—whichis precisely the thing that it cannot show.There is another criterion that in theory canbe used for EPA action.This is that the chem-ical will be produced in “substantial quanti-ties” and that there will be significant envi-ronmental or human exposure. In practice,this criterion only rarely can be used, becausemost new chemicals initially are produced insmall volumes, and because the likelihood ofsignificant exposure is difficult to establish.The problem is even greater for NT materi-als because quantity or volume may not be arelevant indicator of potential risk.

A third problem is that the act requiresEPA to meet a variety of requirements beforeit can regulate a chemical. The difficulty ofthese requirements was illustrated dramatical-ly by the Corrosion Proof Fittings case thatstruck down EPA’s proposed regulation ofasbestos, in part because of inadequate analy-sis—even though EPA had spent 10 yearsdoing the analysis to support the regulation.For example, because TSCA requires that aproposed regulation be the “least burden-some” regulation, the court criticized EPA fornot analyzing the costs and benefits of allother possible ways of regulating asbestos.

These and other shortcomings containedin the act are sufficient to make TSCA a weakregulatory instrument. Furthermore, as withmost government regulatory programs, theresimply are not enough people in the toxicsubstances office to perform the tasksrequired by the law.

2.. Occupational Safety and HealthAct (OSHAct)The OSHAct was passed in 1970 and hasbeen amended frequently since. The act com-bined the occupational safety programshoused in the Department of Labor with the

occupational health functions exercised bythe Department of Health, Education andWelfare (now Health and Human Services).The Department of Labor was given respon-sibility for administering the OSHAct.

The OSHAct’s basic mechanism is for theOccupational Safety and HealthAdministration (OSHA) in the Department ofLabor to set standards and to enforce the stan-dards through inspections and penalties fornoncompliance. An occupational safety andhealth standard is defined in the act (sec. 3(8))as “ a standard which requires conditions, orthe adoption or use of one or more practices,means, methods, operations or processes, rea-sonably necessary or appropriate to providesafe or healthful employment and places ofemployment.”This language is certainly broadenough to cover NT.

The difficulties with using the OSHAct todeal with NT are the same that arise with mostof the environmental statutes.Detection of NTproducts requires expensive and sophisticatedequipment (Ratner and Ratner, 2002,pp.39–42), and it is often unclear whichparameters are the relevant ones to measurefrom the standpoint of toxicity. For practicalpurposes, whether in the setting of a factory orthe ambient environment, detection and con-trol methods (e.g., filters) may not be currentlyavailable or may be too expensive or too cum-bersome. (For a discussion, see Maynard 2005.)

One further OSHA weakness should benoted.Like EPA,OSHA traditionally has beenstarved for resources. In FY 1980 there were2,950 OSHA employees. Twenty-five yearslater, with a greatly expanded economy and alarger number of workplaces, there were 2,208OSHA employees (Dudley and Warren 2005,Table A-3, p.21). EPA has been able to per-form its basic functions because state agenciesdo most of the labor-intensive work, such asinspections and enforcement. However, for

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implementing the OSHAct, only 21 stateshave OSHA-approved plans that allow themto enforce OSHA standards.Three additionalstates have approved state plans for protectingstate and local government employees only(www.osha.gov, accessed 9/7/05). There aremillions of workplaces in the United States,and the chance of being visited by an OSHAinspector is not high.

3. Food, Drug, and Cosmetic Act(FDCA) The FDCA is a one-hundred-year-old actoriginally passed to prevent poisonings fromquack patent medicines and to clean up gross-ly unsanitary conditions in food processingplants. Over the years, it has been frequentlyamended, its scope expanding to cover anincreasing number of areas.

Five types of NT applications are withinthe purview of the FDCA: drugs, medicaldevices, biologics, cosmetics and food.(Medical devices are, roughly, any mechanicalthing used for treatment or diagnosis of dis-ease.) Drugs, biologics and medical devices areregulated quite differently from cosmetics. (Fora discussion of FDA and NT from an industryperspective, see Miller et al 2005, pp.83–102.)

Drugs, biologics and medical devices mustreceive approval from the Food and DrugAdministration (FDA) before they can besold.The approval process is time-consumingand rigorous. The burden of proof is on themanufacturer to show that the product is safe.The process has been criticized by some astoo time-consuming, and by others as notsufficiently rigorous. Recently, there havebeen instances of political interference inFDA decisions, notably the decision to delayapproval of the morning-after birth controlpill. However, overall, the process for approv-ing drugs, biologics and medical devicesworks reasonably well.

Cosmetics are quite a different story.Although the FDCA has a lot of languagedevoted to cosmetics, it is not much of anexaggeration to say that cosmetics in theUnited States are essentially unregulated.The FDCA prohibits the marketing of“adulterated or misbranded” cosmetics ininterstate commerce. “Adulterated” isroughly defined as injurious to health.“Misbranded” means that the label is false ormisleading or does not contain requiredinformation. However, manufacturers ofcosmetics are not required to register withFDA, are not required to file data on prod-uct ingredients, and are not required toreport cosmetic-related injuries to FDA. Ifby some chance FDA discovers a cosmeticthat is adulterated or misbranded, it has noauthority to recall the product or takeaction against the manufacturer. All FDAcan do is ask the Justice Department tobring suit to have the product removedfrom the market. (see www.cfsan.fda.gov,accessed 9/17/2005.)

FDA regulation of food focuses on pack-aging and food additives.As with FDA’s reg-ulation of drugs, there have been someintense food-related controversies (e.g., sac-charin). FDA’s determination not to regulategenetically modified food as a food additivehas been harshly criticized and the agencyhas been faulted for its inadequate monitor-ing of pesticide residues on food. However,FDA’s legal authority under FDCA is ade-quate, and there is not a gross disparitybetween resources available and the regula-tory tasks to be performed.

In light of these facts, it appears that NT-based drugs, biologics and medical devices—and probably NT-based food additives andpackaging—are best regulated under theFDCA authorities. On the other hand,although it would be neater legally and


bureaucratically to regulate NT cosmeticsunder FDCA, the public would be better pro-tected by regulating cosmetics under somealternative regime.

4. Environmental Laws There are many more environmental lawsthan most people realize—at least severalhundred, even using a narrow definition of“environmental.” The vast majority deal withvery specific, narrow subjects, or they areminor amendments to existing laws. Thethree major environmental statutes are theClean Air Act (CAA), the Clean Water Act(CWA) and the Resource Conservation andRecovery Act (RCRA).

The basic mechanism of CAA and CWA isto set standards and to enforce them throughpermits issued to pollution sources.The CAAstandards are mostly ambient and emissionstandards, and the CWA standards are mostlytechnology-based. But RCRA is different.Instead of regulating pollution sources, it setstechnology standards for disposal sites andestablishes a “cradle-to-grave” reporting systemfor hazardous wastes.

The preceding one-paragraph descriptionof three very long (CAA is 448 pages) andcomplex laws is obviously a gross oversimplifi-cation. However, it is hard to imagine howthese laws could be used to manage the adverseeffects of NT products.As was noted above inthe section on the OSHAct, it is difficult todetect nanomaterials except with sophisticatedlaboratory equipment. If these materials cannotbe detected, the provisions of the environmen-tal laws are inoperable. Furthermore, even ifthese materials can be detected, the only prac-tical control in many situations would be toimpose a complete ban on their release intothe environment. Such a ban probably couldbe better handled through a product-orientedlaw like TSCA.The technology-based parts of

the environmental statutes would be inopera-ble because there is no agreed-upon best avail-able technology (BAT) for the removal of NTparticles from air, water, or waste streams.

The processes used to manufacture NTmaterials present a different situation.A recentstudy (Robichaud in press; also see Lekas 2005)examined the potential risks from manufactur-ing five types of nanomaterials, and comparedthe risks with those from a half dozen non-nano processes ranging from petroleum refin-ing to wine making. The risks from the twotypes of processes (nano and non-nano) werefound to be in the same general range—afinding that is not surprising given that themanufacture of NT materials uses inputs andprocesses similar to those in other industries.The study excluded risks attributable to thenanomaterials themselves.While existing envi-ronmental laws presumably can handle ordi-nary emissions from plants manufacturing NTmaterials, it is not clear whether those laws candeal with emissions of NT materials.

It may be necessary to invoke the environ-mental laws if disposal or leakage from manu-facturing facilities is a significant source of NTmaterials in the environment. (EnvironmentalLaw Institute 2005 discusses how these lawsmight be used.) From what we know now, useand disposal of NT products is probably amuch greater source of environmental expo-sure.This brings us back to TSCA-like statutes.TSCA section 6 authorizes the EPAAdministrator to prohibit or otherwise regu-late “any manner or method of disposal” of ahazardous substance or mixture “by its manu-facturer or processor or by any other personwho uses,or disposes of, it for commercial pur-poses.” But this is probably only a theoreticalpoint. In fact, because of other provisions inTSCA, it is unlikely that the provision wouldbe invoked or, if it were, that it would beupheld in the courts.

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There also are releases of nanoparticles thatare not related to NT products. For example,the burning of diesel fuel creates nano-sizedparticles (Goldman and Coussens 2005, p.30).These sources will have to be regulated underthe environmental laws, although detectionand control will be difficult.The focus of thispaper, however, is on engineered nanoscalematerials, not on natural or incidentalnanoparticles.

The one environmental law provision thathas been considered in the NT context is theCAA standard for fine particulates.This stan-dard sets limits on the amount of particulatesless than 2.5 micrometers in diameter that canbe present in the ambient air. (2.5 microme-ters is equal to 2.5 thousand nanometers. Inother words, a 100-nanometer-wide particle,the largest NT particle by the usual definitionof NT (see above), is 1/25 of the small parti-cle CAA standard.) The CAA standard, likealmost all environmental standards, is premisedon a direct relationship between volume orconcentration on the one hand, and risk onthe other. This relationship may not be validfor NT. In any case, volume and concentrationmay not be useful measures if NT is lumpedtogether with larger-sized matter, because thevolume and concentration will be dominatedby the larger-sized material.

5. Other LawsThere are a number of other laws that are rel-evant for NT. If NT materials are used in pes-

ticides, then the Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA)comes into play. If NT materials are used tofilter drinking water, the Safe Drinking WaterAct may apply. Some NT applications couldinvolve radioactive materials, in which case thelaws regulating nuclear and atomic energymatters are relevant. If NT is used in relationto food, there are several laws in addition toFDCA that deal with food safety and purity.

As its name indicates, The ConsumerProduct Safety Act, administered by theConsumer Product Safety Commission(CPSC) is responsible for ensuring consumerproducts are safe. It is, however, a law withmostly hortatory powers. The total staff ofCPSC is 446, less than half the number ofpeople it had in 1980. And even in 1980, itsstaff was inadequate to keep track of the mil-lions of consumer products (Staff numbersfrom Dudley and Warren 2005, table A-3,p.21). Applications of NT in consumer elec-tronics equipment, or in other items like ten-nis balls, would come under the purview ofthe CPSC.

None of these laws has the central impor-tance in NT regulation that TSCA, OSHActand FDCA have. As we have discussed, thereare major problems even with TSCA,OSHAct and FDCA. The next section willconsider whether some of these problems canbe addressed within the NT context.


Several kinds of incremental steps could betaken to manage NT within the existing legalframework. This section explores threeapproaches: coordinating existing laws; amend-ing existing laws to deal with NT; andstrengthening existing laws. These are in noway mutually exclusive.

1. Coordinating MechanismsA coordinated and comprehensive programfor dealing with the effects of NT that isbased on existing laws would: clarify whichlaws would govern in particular circum-stances; specify how different laws wouldrelate to one other if more than one applied;and ensure that there were no gaps or signif-icant duplications in coverage.

Regulation of biotechnology provides rele-vant experience for establishing such a pro-gram. On June 26, 1986, the President’s Officeof Science and Technology Policy (OSTP)issued a “Coordinated Framework forRegulation of Biotechnology” (FederalRegister, vol. 51, #123, pp. 23302-23350).Theframework delineates the policies and respon-sibilities of six different agencies with respectto regulating biotechnology research and prod-ucts. It allocates jurisdiction and responsibilityamong the agencies both for approving com-mercial biotechnology products and for con-ducting biotechnology research. Whereverpossible, it gives responsibility to a singleagency for reviewing product safety.Where thisis not possible, it designates a lead agency, andmandates consolidated or coordinated reviews.

As part of the same effort, the White Houseestablished an OSTP-chaired BiotechnologyScience Coordinating Committee consistingof representatives from each of the agencies.Among other things, the committee helped

get some agreement on consistent definitionsof the genetically engineered organisms sub-ject to review—a key element in any coordi-nated approach. The committee also estab-lished the principle that agencies should usescientific reviews of comparable rigor (ibid.p.23303).

The biotech Coordinated Framework hasbeen in place for 20 years, and, as noted by a2004 comprehensive review (Pew 2004, p.3),“The adequacy of the CoordinatedFramework has been a matter of disagree-ment from the beginning.” Interestingly, thereview report notes that, “While the policyremains that genetically engineered productsshould receive the same regulatory treatmentas similar, conventionally produced products,in practice agencies have developed a hybridsystem that effectively treats biotechnologyproducts differently. In part, this evolution hasresulted from the difficulty of fitting biotech-nology products into pre-existing legal cate-gories…and in part due to the perceivedpublic interest in affording GE [geneticallyengineered] products greater scrutiny” (ibid.p.10). The same evolution could take placewith NT products.

In theory, a framework for NT could beestablished similar to the biotechnology frame-work. However, NT probably covers an evenbroader array of types of products than doesbiotech.Also, it is too early to know the typesof products that will incorporate NT, so anagreement might be more difficult. A greaterobstacle is the difference—with respect tophysical and biological behavior—betweenNT products and larger-scale products of thesame molecular composition. EPA cannot reg-ulate carbon nanotubes as if they were justsmall amounts of carbon compounds, because

16

Applying Existing Authorities

the nanotubes behave quite differently in theenvironment, and probably in the human bodyas well.The same is true of other types of NTproducts.This means that an effective regulato-ry mechanism must involve internal changeswithin each of the agency programs and notjust allocate responsibilities among agencies.

The current federal coordinating mecha-nism for NT is the Nanoscale ScienceEngineering and Technology (NSET) sub-committee of the National Science andTechnology Council Committee onTechnology (see www.nano.gov). NSET hasestablished a Nanotechnology Environmentaland Health Implications Working Group.Thesubcommittee and the working group havefocused on research and development. NSETcould evolve to deal with regulatory and poli-cy issues as well as research,but it does not havethe membership or authority to do so now.

2. Amending Existing LawsSome of the aforementioned problems—andquestions about whether particular laws (e.g.,TSCA) cover NT—could be addressed byamending individual statutes to make clearthat they do cover NT. While this wouldavoid a lot of litigation, winning the approvalof numerous congressional committees andthe executive branch for such legislationwould be a formidable challenge.

There also would be the major substantiveproblem of deciding how to define what iscovered. Is it possible to define NT just by thesize of the material? What if the NT material iscombined with a non-NT material? If onemanufacturer makes carbon nanotubes and

another manufacturer makes a textile thatincorporates the tubes,do you regulate both? Ifthe nanotubes are used in a medical device,what role would FDA play? What happens inthe future when NT is combined with genet-ic engineering? While it might be possible toarrive at reasonable answers to these kinds ofquestions, it would require a lot of time, effortand foresight.

3. Strengthening Existing Laws Even assuming that existing laws could beamended to clarify and make explicit theircoverage of NT—and that the patchwork ofexisting laws could be stitched together in acoordinated framework that would performbetter than it has for biotech—one still wouldbe left with the weaknesses contained in theselaws.Section II delineated some of these weak-nesses. TSCA still would lack authority torequire risk data. FDA still would not be ableto review and regulate the ingredients of cos-metics. OSHA still would lack resources.

In the current political climate, it is incon-ceivable that these weaknesses could be reme-died. It would be easier, politically and sub-stantively, to draft and enact a new lawfocused on NT. I turn to an outline of such alaw in the next section.

Even if there is agreement that there shouldbe a new law, it will take months—and prob-ably years—before a new law is enacted. In theinterim, regulators would have to use existinglaws in the best possible way. Thus, how thecurrent laws can be applied to NT, and whatresources will be required to effectively applythem, are inescapable and important issues.


Given all the difficulties of using existing lawsto address the potential adverse effects of NT,there is much to be said for considering acompletely new law.New legislation could betailored specifically to take account of thecurrent characteristics of NT as well as char-acteristics we expect to emerge in the nextdecade or two. A new law also could takeadvantage of what we have learned about reg-ulation in the past four decades.

The wide spectrum of products and mate-rials included in NT means that the lawwould have to be broad enough to cover all ofthese products and materials.At the same time,the law would have to allow for broad cate-gories of exemptions—perhaps up to 80 or90 percent of NT products—if resourcedemands were not to become prohibitive.Therapid development of NT would require aregulatory structure that is flexible and thatdoes not unduly impede development of thetechnology.The lack of data about the adverseeffects of NT means that the law would haveto be structured to provide incentives fordeveloping effects data and making it available.

Section II noted the near impossibility ofpassing new regulatory legislation (includingstrengthening of existing laws) in the currentpolitical climate. However, this could change.The political climate could shift because ofchanges in the nation or the global competi-tive climate.A dramatic event or crisis affect-ing some aspect of the environment—orinvolving NT directly—could create anopportunity or a demand for new legislation(see Kingdon 1984). A broad consensus, per-haps fed by disparate state and local regulato-ry action, could emerge to favor NT legisla-tion. The insurance companies, concernedabout the liability of their industry customers

(see Swiss Re 2004), and the EuropeanUnion, which has been more active aboutregulation than the United States, are con-stantly pressing for action on NT. The NTindustry might endorse legislation as a way ofassuring the public about the safety of NT.

Because of these possibilities, and becausethinking about NT legislation is itself amechanism for reaching agreement aboutwhat should be done, this section of the paperoutlines what a new NT legislative initiativemight look like.

1. DescriptionI begin with the assumption that a new lawwould focus on products, not on the environ-ment, because once NT materials get into theenvironment, it is probably too late to takeremedial measures. The law should focus onprevention, not cleanup, for the same reason.Thus, the general framework looks somethinglike TSCA or FIFRA, or the drug part ofFDCA.

Given the lack of NT effects data, it wouldbe necessary to place the burden on the man-ufacturer to show that the proposed product issafe. As more is learned about classes of NTproducts, it may be possible to carve out cate-gories of exemptions, or types of products thatrequire less information.

The process that the law would prescribecan be envisioned in four stages: ground rules,sustainability plan, review and follow-up.

In the first stage, EPA (assuming EPA is thelead agency) would have to define the law’scoverage. Providing a workable definition ofNT products will not be easy. It does seemclear that all products containing NT materi-als will have to be covered, not just the basicNT materials.The reason is that both exposure

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A New Law

and toxicity are not predictable from the NTmaterial alone.The exposure and toxicity of acarbon nanotube or a titanium nanoparticle,for example, will depend on what structure itis shaped in, what other materials it is usedwith, and how it is used. Regulations probablyshould require labels on NT materials statingthat any product using the material must beregistered with and reviewed by EPA.

There are at least two further definitionalissues. The first is: Should the coverageexclude products covered by other laws? Ithink the answer is yes, provided that the cov-erage of the law is really adequate to protectthe public. Thus, drugs, biologics, medicaldevices, food additives, pesticides and nuclearmaterials all would be excluded. However,cosmetics, for example, would not be exclud-ed because there is no regulatory review ofcosmetic products.The second issue is:Whatdo we do about NT products already on themarket? Should the law be applied retroac-tively? I think probably not, because theresource burden on both the regulatingagency and the manufacturers would beunmanageable. However, the law should con-tain provisions for restricting products alreadyon the market if it is discovered that they arehaving an adverse effect.

EPA also would have to establish testing andreporting requirements. The requirementsshould be coordinated internationally and, ide-ally, would be the same in all nations. Thiswould benefit manufacturers as well as govern-ments.The International Life Sciences Institute(ILSI) has developed the elements of a detailedscreening strategy for human health effects ofnanomaterials (ILSI 2005).

The testing requirements would build on aset of protocols that describe how each type oftest should be done. What tests are requiredwould be based on the type of product and theresults of previous tests (a decision tree). The

testing requirements also could be tiered overtime, although it is not clear what the basis ofthe tiers would be. Current EU chemicals lawrequires more testing as the volume of thechemical produced increases. However, this isprobably not a good basis for tiering the test-ing of NT materials.

The reporting requirements, which alsocould be coordinated with other nations,should place as small a burden as possible onthe manufacturer, but provide enough contin-uing information to alert the government if aproblem arises. At a minimum, the manufac-turer should be required to report results of anytests conducted on adverse effects, as well asany information received about adverse effectsoccurring. Less information could be requiredof companies with good health and environ-mental records.

In the second stage, the manufacturerwould submit a sustainability plan (SP) to EPA,preferably in electronic format.The SP wouldhave six components: 1) a life cycle analysis ofthe material or product; 2) testing results; 3)proposed future reporting requirements; 4)proposed labeling of the product; 5) proposedrestrictions, if any, on the product; and 6) anexplanation of why the product risk, if any, isacceptable. The burden of proof for showingthat the product does not pose unacceptablerisks belongs to the manufacturer.

In the third stage, the government wouldinitiate a review process, the endpoint of whichis to approve the SP, approve it with changes,ordisapprove it.The criterion for approval is thatthe product will not create any “unacceptablerisks,” a term which the law would have todefine with great care. (In my view, unaccept-able risk is no more or less stringent than“unreasonable risk.” I have avoided the latterterm because I would like to encourage a moreflexible definition than has been given tounreasonable risk.)


There are several, not necessarily mutuallyexclusive, approaches that could be taken todefining unacceptable risk. First, and mostobvious, the manufacturer might have to antic-ipate likely risks from the product and showeither that they would not occur if reasonablesteps were taken to prevent them, or that, ifthey occurred, the actual damage would bevery small. A second possibility is to take arough cost-benefit approach.That is, some riskswould be deemed acceptable if the benefits ofthe product clearly outweighed the risks. If theproduct cured cancer, for example, some risk ofdeath in unusual cases would be acceptable.Athird approach is based on comparative risk.Aproduct’s risk might be acceptable if it could beshown clearly that it would substitute for amaterial that had greater risks. Some combina-tion of these approaches, as well as other possi-bilities, needs to be considered.

A review stage should strike a balancebetween allowing a sufficient amount of con-sultation with interested parties and minimiz-ing the time taken to approve or disapprove theSP.The general public needs to have an oppor-tunity to comment, and administrative lawusually requires that the public be given at least60 or 90 days to make comments. If a publichearing is requested or required, however, thetime consumed by public review will be con-siderably greater.And while other nations alsoshould be consulted, this could be very timeconsuming, even when aided by electroniccommunications.

At present, there is no institutional struc-ture to formulate or facilitate internationalregulation.The amount of time and degree ofdetail necessary for international consultationwill depend on how much agreement there ison the basic regulatory framework. Ideally,there would be complete consistency amongmajor nations, so that approval of a product inone country constituted approval globally.

However, if this were the case, other countriesmight have to be given enough time to reviewthe SP themselves. Protection of confidentialbusiness information is another importantconsideration that must be incorporated intothe review process.

There is a need for coordination amongU.S. agencies for all decisions regarding a par-ticular material or product, as well as for gen-eral policies on matters such as risk assessmentand labeling.Any new statute should mandatecoordinated policies and decisions and shouldestablish an interagency group to implementthe mandate.

The review stage may provide companiesadditional incentives for developing environ-mentally beneficial products (see Section Vbelow). If there were tax incentives for devel-oping such products (see Section V-2), EPAcould decide whether the product qualified fora tax benefit, or could provide input for such adetermination by the Treasury Department.Also, the approval process could be speeded upin various ways for products that had majorhealth or environmental benefits.

The follow-up stage would have toinclude provisions for dealing with new usesof a product, and for requiring further testingif new evidence comes to light.Again, the lawwould need to be balanced between givingthe government the information it would likebut not imposing on manufacturers burdensthat would stifle entrepreneurship. Anothertradeoff involves enforcement and judicialreview.TSCA has been rendered almost inop-erative because of the difficulties of enforcingthe law and defending against attacks in thecourts. However, the rights of the regulatedparties and the general public also need pro-tection.A balance should be struck.Any newlaw would have to deal with a variety of otherissues such as imports, exports, nationaldefense and citizen lawsuits.

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2. Advantages and DisadvantagesA new law focused on NT would have twomajor advantages, especially in light of theproblems outlined in Section II: It couldavoid some of the pitfalls of previous regula-tory laws, and it could be tailored to the par-ticular characteristics of NT. By being able todefine NT and nanomaterials in a legal con-text, a new law would avoid the distortionsand problems that come with trying to shoe-horn NT into the definitions (e.g., “chemi-cals”) in existing law. The task of enactingmajor new legislation, however, requires mus-tering political strength and wisdom. Thepolitical strength for that task may not mate-rialize unless an extraordinary consensus—one involving industry, environmental groupsand regulators—emerges.

Compared to the existing laws, the type oflegislation outlined above could providegreater protection for the public. It also mightplace a greater burden on manufacturers, espe-cially small start-up companies. The choicebetween protecting public health versus pro-tecting small business and technological inno-vation can be very stark, but in the context ofNT, it may be less so.While much of the com-mercial innovation in NT comes from smallstart-up companies, a discussion of the struc-ture of the NT industry notes that,“Most nan-otechnology start-ups will not attempt todevelop and market their own commercialproducts.Rather, they will seek to partner withlarge companies in industries that can utilizenanotechnology to improve their commercialproducts” (Miller et al 2005, p.37). Also, thegovernment can take various steps to ease theburden on smaller companies, such as establish-ing an office devoted to assisting small business.It also can provide templates, guidebooks andother technical assistance.

A new law could strike a different balancebetween safety and innovation than the one

outlined above.Two simple, but far-reaching,changes could fundamentally shift the balanceof the legislation. First, the burden of proofcould be placed on the government to showthat there is unacceptable risk. While thiswould remove any incentive for manufactur-ers to develop information about their prod-ucts, it would be more consistent with muchof American law. Second, in tandem with thisshift in burden, the law could set a time limiton the government’s review, so that after agiven time, such as 90 days, a company couldmarket its product unless the governmenttook legal action to prevent or delay market-ing.With these changes, the new law wouldlook much like TSCA,with many of the sameweaknesses with regard to public health andenvironmental protection.

From the perspective of the regulatingagency, the advantage of getting adequateinformation is somewhat offset by the prob-lems of reviewing and managing a largeamount of data.The experience with TSCA isinstructive. EPA generally has not pursued theavenue of requiring test data for new chemi-cals, mostly because of the weakness of thelaw’s provisions allowing it to do so, but alsobecause it feared that its limited resourceswould not allow it to review most of the sub-mitted test data. Given that there is an expec-tation that a large number of NT productsand applications will materialize in the com-ing years, the regulators’ workload and capac-ity will have to be considered in the regulato-ry regime.

3. Other OptionsThe major alternatives to new legislationinclude: working within the existing statutoryframework, creating a voluntary program, orimposing a ban on NT commercialization.Sections II and III discussed the possibilities ofworking within the existing laws.


EPA proposed a voluntary program for NTin September 2005 (U.S. EPA 2005).The pro-gram would ask producers of engineerednanoscale materials to submit to EPA, formaterials chosen by the producer, informationon: 1) material characterization; 2) hazardinformation;3) use and exposure potential; and4) risk management practices. If basic informa-tion on material characterization (such as sur-face area, solubility or chemical composition)were missing, the voluntary program partici-pant would be expected to generate the infor-mation, but there is no expectation that anyother information would be generated for theprogram.A separate “in-depth”program wouldfocus on a more limited number of materials,and would ask participants to generate andreport risk information specified by EPA.Thatinformation is intended to allow the agency toconduct a full risk assessment of the identifiedmaterials and associated uses. Both programsare designed to help EPA develop a permanent(and, presumably, non-voluntary) regulatoryprogram for NT.

A key question to ask about any voluntaryprogram is:What incentives are there for peo-ple to join the program and comply with itsrequirements? (See the essays by Mazurek andby Harrison in Dietz and Stern 2002.) Forexample, the 33–50 program, one of the firstmajor voluntary efforts initiated by EPA, askedcompanies to volunteer to make major reduc-tions in toxic air emissions. Many companiesvoluntarily made the reductions, but they wereencouraged to do so by the fact that in a fewyears they almost certainly would be forced todo so by enforcement of the Clean Air Act.

The primary incentives for joining the vol-untary EPA NT program are that it wouldprovide companies “a concrete means todemonstrate their individual and collectivecommitment to responsible nanotechnologydevelopment,” and that it would give partici-

pants “an opportunity to help determine thebest ways to evaluate and address the potentialrisks”of NT (US EPA 2005).Many companiesinvolved in NT fear a public reaction againstNT, which might be fed by a lack of regula-tion.They also fear the possibility of over-reg-ulation by EPA and other regulatory agencies.Thus, the incentives offered by the EPA pro-gram have some appeal, and may be sufficientto motivate companies to participate. Becausethe demands of the proposed program are fair-ly modest, non-compliance from those whodo participate should not be a problem. Anexception may be the withholding of existingnegative risk information.

A major disadvantage of voluntary pro-grams is that they may leave out the peoplewho most need to be included. In the case ofNT, small firms making risky products andlarge firms with small consciences are notlikely to volunteer to do health testing or togive EPA information that might indicate asignificant risk.

The other major option to new legislationis a ban either on commercialization of NTproducts or on NT research. ETC, the ActionGroup on Erosion, Technology, andConcentration, a Canadian-based organiza-tion, has stated: “Given the concerns raisedover nanoparticle contamination in livingorganisms, Heads of State … should declarean immediate moratorium on commercialproduction of new nanomaterials and launcha transparent global process for evaluating thesocio-economic, health and environmentalimplications of the technology (ETCCommunique, Issue 76, May/June 2002).This is, as far as I know, the only organizationthat has called for a ban on NT. Focus groupsconvened by the Project on EmergingNanotechnologies indicate that only a smallminority of the general public support a ban(Macoubrie 2005, p.17).

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The British Royal Society (2004, p.8) didrecommend that:“Until more is known aboutenvironmental impacts … the releases of man-ufactured nanoparticles and nanotubes into theenvironment should be avoided as far as possi-ble.” It also recommended prohibiting “the useof free (that is, not fixed in a matrix) manufac-tured nanoparticles in environmental applica-tions such as remediation”until more is knownabout the risks and benefits of such use (ibid.).

A ban is consistent with the “precautionaryprinciple” which, in one of its simplest forms,says you will not undertake any action unlessyou know that it will not have any unaccept-able consequences. (There are many versionsof the precautionary principle and many dis-cussions of it. For a good overview, see Durantin Durant et al 2004.) The wisdom of a bandepends on weighing the potential benefits ofcontinued development of NT against theseverity and likelihood of any adverse conse-quences resulting from the technology. Mostknowledgeable observers believe that the ben-efits of NT will outweigh the adverse conse-quences, especially if steps are taken to mini-mize adverse effects.

Another option is labeling. Some haveargued that consumers are entitled to know ifproducts contain nanomaterials. Labeling alsocan benefit manufacturers by allowing themto determine the contents of supplied goodsand/or the supplier’s conformance with goodpractices. While labeling is a supplement,rather than a substitute, for the broader pro-grams outlined above, it could be important.For example, if NT product review were not

made retroactive, products already on the mar-ket might be labeled to indicate that they hadnot been reviewed by the government.Thereis not a lot of empirical evidence about theeffectiveness of labeling, although the availableevidence indicates that labels often do nothave much impact on consumer behavior (seeLutzenhiser and also Thogersen in Dietz andStern 2002).

State pilot programs are yet anotheroption. NT development is concentrated infewer than a dozen states, and, in theory, astate could initiate a program at least to col-lect data on NT uses and effects. Given theintense interstate competition to attracthigh-tech industry, it seems doubtful that anystate would have much incentive to take suchan initiative. Several states have initiated pro-grams to encourage NT as part of their eco-nomic development efforts (see, for exam-ples, www.watechcenter.org; www.ccst.us).Washington State has called the competitionto attract nano companies “one of the mostintensely competitive technological races inhistory” (www.watechcenter.org, p.1,accessed 11/2/05).

Some would say that the most likely optionalways is to do nothing, taking no initiatives todeal with NT’s adverse effects. But that wouldserve no one’s interest. The public would beleft unprotected, the government would strug-gle to apply existing law to a technology forwhich it was not designed, and industry wouldbe exposed to the possibility of public fear andoutrage over a powerful, mysterious, andpotentially dangerous new technology.


An important aspect of managing NT is toencourage its application to environmentallybeneficial uses. Most applications of NT areenvironmentally beneficial in that they reducethe amount of material necessary for a partic-ular purpose. However, there are more specif-ic environmental benefits that NT may makepossible. For example, NT materials alreadyhave been used to remove toxic materialsfrom soil at contaminated sites (Oberdorster2005, p.4).

Government initiatives to encourage envi-ronmentally beneficial NT also should be usedto encourage applications that benefit publichealth. In fact, failure to treat NT public healthand environmental applications equally wouldbe morally and politically untenable.This sec-tion discusses four mechanisms that can beused to encourage applying NT to environ-mental protection and public health: research,tax breaks, acquisition programs and regulato-ry advantages. While each of these is worthconsidering, each has significant problems.

1. Research The most direct way for government toencourage beneficial NT is for the govern-ment (usually federal, but possibly state orlocal) to conduct the research itself.Alternatively, the government can pay forresearch, but let others do the actual workunder contract. A third possibility—one inwhich the government has less control overthe research—is for the government to awardresearch grants.

In 2000, President Clinton started theNational Nanotechnology Initiative (NNI),which included $422 million of funds from

various agencies. The 21st CenturyNanotechnology Research and DevelopmentAct (P.L.108-153), enacted in 2003, provided astatutory base for the NNI. (The text of the actand description of the program can be foundat www.nano.gov.) The NNI is an interagencyeffort under the general direction of theNational Science and Technology Council.The NNI included $989 million for researchcontained in the budgets of 11 agencies in FY2004. In 2005, the amount is estimated toincrease to $1.08 billion.The President’s budg-et requests $1.05 billion in FY 2006. Of the2006 request, $230 million is in the DefenseDepartment budget. EPA is requesting $5 mil-lion. Overall, 4 percent of the federal funds goto research on the health and environmentaleffects of NT and another 4 percent goes to“education-related activities and research onthe broad implications of nanotechnology forsociety” (www.nano.gov).

Several U.S. states have appropriatedmoney for NT research as part of the compe-tition for economic growth. In 2000,California allocated $95 million toward aNano-Systems Institute at the University ofCalifornia Los Angeles and Santa Barbara. In2003, Oregon appropriated $21 million tolaunch a Nano/Micro Institute, and New Yorkcontributed $50 million to a NanotechCenter at SUNY Albany (WashingtonNanotechnology Initiative, www.wanan-otech.org, p.3, accessed 11/2/05).

Many other national governments arefunding NT research.The European Union isspending significant amounts. In 2004, scien-tists in China published more articles onnanoscience and nanotechnology than scien-

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Incentives for Environmentally Beneficial Technology

tists in the United States, and China now ranksthird behind the United States and Japan inNT patents (Hassan 2005). A recent survey(Choi 2005) found the United States, Japan,Germany and South Korea to be the dominantnations in NT research and development.

The effectiveness of this research forencouraging environmentally beneficial NT isunknowable now and may never be known.(Miller et al 2005, pp. 115–130, analyze theNNI program and consider it successful.)Dramatic successes and failures of governmentR&D programs are widely publicized, butoverall evaluations of such programs are rare. Inthe United States, it is hard to know what por-tion of government R&D funds go to NTtechnologies that are directly or indirectly ben-eficial to health and the environment. Thisshould be a continuing concern of the NNI.

2. Tax Breaks Tax benefits have been an important tool forprotecting the environment. The ByzantineU.S. tax code contains a variety of incentivesfor environmentally beneficial behavior such asenergy conservation.

Tax penalties to discourage pollution orother socially undesirable behavior have beenused in the United States, but are more com-mon in European countries. For example, gastaxes are much higher in most OECD(Organization for Economic Cooperation andDevelopment) countries than in the UnitedStates (Davies and Mazurek, 1998, p.211).

Although one can argue that any imagina-ble provision can find its way into the U.S. taxcode, there are at least two significant obstaclesto using taxes to encourage environmentallybeneficial NT.

One obstacle is that there has never beenstrong support for such use of the tax system.In particular, environmental groups have beencool to economic incentives of any kind.The

tax-writing committees in Congress, especiallythe powerful House Ways and MeansCommittee, most frequently have taken theposition that taxes should be used only to raisegeneral funds for running the government andhave opposed using taxes for social purposes.The Treasury Department usually has support-ed the committees in this opposition.The factthat some large corporations are engaged inNT research and development does provide apotential base of support for tax subsidies.

The other obstacle lies in defining whichexpenditures would be eligible for tax subsi-dies or tax penalties.The definition of whichproducts or processes are NT is not altogeth-er clear, and defining which NT efforts areenvironmentally desirable is much moreproblematic.The need to make economicallyimportant decisions about poorly delineatedcategories leads to confusion at best, and tocorruption at worst.

3. Acquisition ProgramsThe federal and state governments are majorconsumers of a broad variety of goods andservices. This characteristic has occasionallybeen used to promote social goals. For exam-ple, the Clean Air Act (section 248) says thatthe General Services Administration (GSA)should underwrite the incremental cost ofpurchasing clean fuel vehicles for use in feder-al agency fleets. In theory, the governmentcould be required to purchase environmental-ly beneficial NT products. Such a mandatewould raise the same definitional problems astax breaks. More fundamentally, it would raisea dilemma that has characterized most acquisi-tion proposals, one of cost versus social goal.Government agencies generally behave likerational consumers, searching for the lowestprice for a given product. If the products man-dated to be purchased are less expensive thancomparable products, agencies will buy them


in any case and the legislation is unnecessary. Ifthe mandated products are more expensive, theagencies will be reluctant to spend their budg-et money to fulfill a purpose that is not part oftheir mission, and the acquisition program getsquietly undermined by the resistance of pur-chasing agents in individual agencies. To theextent that government purchasing is donecentrally by the GSA, the chances of acquisi-tion programs succeeding are slightly better,but the basic dynamic remains.

4. Regulatory IncentivesThere have been a few instances of using reg-ulatory incentives to encourage particulartypes of technologies.For example,FDA accel-erates the review and approval of certain typesof drugs that address unmet medical needs (seewww.accessdata.fda.gov). It would be possiblefor FDA to give some advantage to NT drugs

and medical devices if this were considereddesirable. It also would be possible to do thisunder new legislation dealing with NT, such asthe proposal outlined in Section IV above.TSCA does not lend itself to such incentivesbecause there is a set time limit (90 days,extendable to 180 days) for EPA to make adecision about a chemical. At the end of thetime period, the chemical can be manufac-tured unless the agency has taken steps to banor limit its manufacture.

How much of an incentive a regulatoryprovision is depends on how much capital hasbeen invested in the product before the regu-latory decision,and on how much time is savedby the regulatory advantage. In the case ofsomething like a new drug, where the devel-opment expense typically is large and the reg-ulatory delay could be lengthy, a regulatory legup can be an important incentive.

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Dealing successfully with NT’s adverse effectswill require the establishment of new institu-tions or institutional mechanisms.While neces-sary to deal with NT, these institutions andmechanisms also are necessary for dealing witha wide variety of other problems and policies.Although they are discussed in the context ofNT, their broader relevance should be kept inmind.The four most important functions thatrequire institutional strengthening and innova-tion are international harmonization, foresightcapability, research and public participation.

1. International Harmonization Any effort to address NT must be interna-tional in scope. Every aspect of the new tech-nology is international. As noted above,research on NT is being conducted in a largenumber of countries. Research and develop-ment are not limited to OECD nations—South Korea, China, India and Brazil, amongothers, are major players. Furthermore, mostof the firms marketing or likely to market NTproducts engage in international outsourcing,licensing of firms in other countries, andother actions across national boundaries thatmake the notion of “country of origin” seemquite outdated.

A regulatory regime for NT should haveinternational coordination built into it. Thefailure of the U.S.TSCA to do this is one ofits many weaknesses.The section of this paperthat discussed creation of a new law describedsome ways this might be done. Additionalideas are needed.

An international coordinating body wouldgreatly strengthen national efforts to manageNT. One possibility is for OECD to establishan International Council on the Effects ofNanotechnology (ICEN). Membership would

not be limited to OECD countries and shouldinclude UNEP (United Nations EnvironmentProgram) and WHO (World HealthOrganization). The council would have threemajor functions: 1) sharing and disseminatinginformation on the health and environmentaleffects of NT; 2) making non-binding recom-mendations for government actions to manageNT’s effects; and 3) evaluating the actionstaken by member states to address the effects ofNT.The last function would be analogous toOECD’s evaluations of national environmentalprograms (see, for example, OECD 1996,OECD 2000).

The current international mechanisms fordealing with environmental and technologi-cal problems are a crazy-quilt of small, mostlyinadequate, institutions and staffs.An interna-tional coordinating body for NT could bejust an interim step. At some point, the needfor a single strong international body to man-age all of the environmental treaties, agree-ments and understandings will becomeimperative. The need to deal internationallywith NT will add one more reason fornations to create such a body.

2. Foresight CapabilityThe U.S. EPA, the National ResearchCouncil (NRC) and others have called forthe development of an improved technologyforecasting ability to identify potential envi-ronmental impacts of emerging technologies,to interact with business in the early stages oftechnology development to help design outnegative impacts, and to support environmen-tally positive applications (Olson, B. andRejeski, D.,“The Challenge Ahead” in Olsonand Rejeski 2005; also see Brewer and Stern2005, pp. 104–107).

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New Institutional Capabilities

Managing the Effects of Nanotechnology

There has been a long, on-going debateabout the ability to do forecasting. If the goal isaccurate prediction of the future, then mostforecasting is doomed to failure. However,thinking about the future allows one to con-sider likely options, identify important deter-minants of the future of a technology, and geta jump on creating relevant policies.The rapidpace of NT makes improved foresight capabil-ity a necessity.

Several kinds of initiatives are needed.First,EPA and other agencies should establishoffices explicitly charged with forecasting—and with encouraging their agency to useforecast results. Second, NSF, EPA and othersshould fund academic centers dedicated toresearch that will improve forecasting ability.Alot of research on how to improve forecastingis needed (Brewer & Stern 2005, pp.230–245;Ascher 1978), but forecasting is inherentlyinterdisciplinary, and for this and other rea-sons, it has been almost entirely neglected byacademics. The availability of funding forresearch —and the existence of institutionsthat would use the results—would help rem-edy this neglect. As the NRC has said, manyreasons exist to motivate forecasting activities.Among them is the desire to increase the leadtime for making decisions in order to allowmore careful analysis of various options, and toincrease the chance for broad public participa-tion in decision making (Brewer and Stern,2005 p.104). In managing NT’s effects, thesereasons are particularly relevant.

Congress also needs to have the ability toforesee and evaluate new technological devel-opments. In 1995, the Republican Congresseliminated the Congressional Office ofTechnology Assessment (OTA), the onlyeffective institution it had for fulfilling thesetasks. It eliminated OTA as a budget-cuttingmeasure, although the total OTA budget wasa modest $22 million. Rebuilding Congress’

foresight capability is essential if the legisla-ture is to operate effectively in the modernworld (see Morgan and Peha 2003; Goldmanand Coussens 2005, p.10).

3. Research Section V-1 discussed the role of research inencouraging environmentally beneficial NT.However, there is also a need for researchfocusing on adverse effects of NT, monitoringinstruments, and control methods to preventadverse effects. Much of the research on effectsis either done or paid for by the government.

NT presents a variety of unique challenges.It is not clear whether there are good ways todetect NT materials in the ambient environ-ment, or, if they cannot be detected, whetherthere are ways environmental controls can beimposed. It is not clear which, if any, of theusual control methods will be effective in deal-ing with NT materials. Following theseavenues often leads back to the primaryimportance of prevention. The only way todeal with potential adverse effects of NT inmost cases will be to design the product or tai-lor the use of the material so that the NTmaterial does not get into the environment orthe human body in the first place.

Rejeski has suggested that EPA needs anadvanced research capability similar to the mil-itary’s Defense Advanced Research ProjectsAgency (DARPA) to develop breakthroughsolutions for the “really hard problems” (Olsonand Rejeski 2005, p.172). EPA’s track recordwith research of this kind is not good, but cre-ation of a new office with incentives to attractoutstanding researchers could change this.

It will remain a continuing challenge toidentify and analyze the adverse effects of NT.With government funds, some new institutionsat universities already have been established todo research on these effects. Much of theresearch on effects is cross-disciplinary—a

28

major handicap in enlisting the discipline-ori-ented universities to undertake the research. Italso is a handicap in enlisting individualresearchers who may not get academic rewardsfor working on interdisciplinary, applied prob-lems.The question of how to create incentivesfor the private sector to conduct testing and doresearch on NT adverse effects is a differentkind of institutional challenge. Holding manu-facturers responsible for the adverse effects oftheir products is clearly a major incentive forsuch testing and research.

There is broad agreement that current gov-ernment spending to determine the health andsafety effects of NT is inadequate.At a Nov.17,2005, hearing before the House Committeeon Science, industry, environmental andresearch organizations called for federal spend-ing of at least $100 million annually—morethan three times current expenditures —onhealth and safety research (Couillard 2005).Some witnesses also called for a more activelymanaged, strategically targeted, and carefullycoordinated approach to determine whatadverse effects, if any, NT may create.

Recently, the Project on EmergingNanotechnologies at the Woodrow WilsonCenter released a comprehensive inventory ofNT-related environmental, health and safetyresearch (Maynard 2005b).The inventory cov-ered information on 208 research projects, in 6countries and regions, accounting for $38 mil-lion of research annually.169 projects, account-ing for $27 million, were in the United States.However, within the United States, only $6million of federal research was considered to beof “high relevance” to determining the envi-ronmental, health and safety implications ofengineered nanomaterials.

4. Public ParticipationThe involvement of members of the generalpublic is crucial for dealing with NT’s adverse

effects in two different ways. First, as the RoyalSociety (2004, p.62) states,“some of the socialand ethical concerns that certain applicationsof nanotechnologies are likely to raise stretchwell beyond the basic science or engineeringof the matter” (see also Roco and Bainbridge2001). Social values, apart from scientific ques-tions, are an inextricable part of assessing risks(Stern and Fineberg 1996), and the publicneeds to be involved in assessing NT’s risks, aswell as in defining the measures to be taken todeal with the risks.

The social value questions that NT is likelyto raise transcend the risks of individual tech-nologies or applications. A study comparingthe controversy over biotechnology with whatmight be expected in relation to NT notedthat the issues many people saw as beinginvolved in the biotechnology controversyincluded “Global drives towards new forms ofproprietary knowledge; shifting patterns ofownership and control in the food chain; issuesof corporate responsibility and corporatecloseness to governments; intensifying rela-tionships of science and scientists to the worldsof power and commerce; unease about hubris-tic approaches to limits in human understand-ing; conflicting interpretations of what mightbe meant by sustainable development…”(Grove-White 2004, p.19). As the authorspoint out, these kinds of concerns cannot beaccommodated within a framework of riskassessment of individual NT products.

The second way the public needs to beinvolved is as consumers both of informationabout NT and of NT products.The tremen-dous potential of the technology will notdevelop without the public having a realisticview of the intended and unintended effects ofNT. In its scope and diversity of applications,NT often has been compared with biotech-nology.The lessons learned from biotechnolo-gy about the consequences of a poorly


informed public should not be lost on thosedealing with NT. Some institutions have risento this challenge. For example, DuPont hasjoined with the non-governmental organiza-tion Environmental Defense to define aprocess for identifying and reducing potentialhealth, safety and environmental risks ofnanoscale materials, and to test the process onspecific DuPont materials or applications.

A study by the Woodrow Wilson Center’sProject on Emerging Nanotechnologies(Macoubrie 2005) showed more trust in regu-latory agencies than might have been expect-ed. Almost half the sample believed that EPA,OSHA and other regulatory agencies wouldeffectively manage risks from nanotechnology,while about 40 percent believed the agenciescould not be trusted.Of the 177 participants inthe study, 55 percent said that voluntary stan-dards applied by industry would not be suffi-cient to deal with NT risks. When asked fortheir top choice of how government andindustry could increase public trust, 34 percentselected increased safety tests before productsare marketed, and 25 percent chose supplying

more information to support informed con-sumer choices (ibid. p.19).

New and better institutions for public par-ticipation are needed (Beierle and Cayford2002, p.74; Brewer and Stern 2005, p.37).Going through the motions of a public hear-ing where nobody listens, or launching a slickpublic relations campaign will not suffice.Thepublic needs to be educated, not brainwashed.It needs to be seriously listened to, not tolerat-ed. And there needs to be real participation.New forms of participation are being tried, forexample, using the Internet, and NT providesa good opportunity to use and experimentwith these new methods.

The challenges presented by NT are as manyand varied as the promises that it holds for abetter life. If the new technology is to fulfill itspromise, society must openly face the issues ofwhether the technology has or could haveadverse effects, what these effects are, and howto prevent them. I hope that this paper willmove that effort forward.

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Ascher,William, 1978. Forecasting, Baltimore, Johns Hopkins U. Press

Bierle,Thomas C. and Jerry Cayford, 2002.Democracy in Practice, Washington, D.C.,Resources for the Future

Brewer, Garry D. and Paul C. Stern, eds., 2005.Decision Making for the Environment, Washington,D.C., National Academies Press

Carlstrom, Paul, 2005.“Nanotech Material Toxicity Debated,” San Francisco Chronicle, Sept. 12

Choi, Charles Q., 2005.“Nano World: National Ranking in Nanotech,” UPI, Nov.7

Couillard, Lauren, 2005.“Safety, Health Research on Nanotechnology Said to Need At Least$100 Million Per Year,” Daily EnvironmentReport, No. 223, p.A-5 (Nov. 21)

Davies, J. Clarence, and Jan Mazurek, 1998.Pollution Control in the United States,Washington, D.C., Resources for the Future

Dietz,Thomas, and Paul C. Stern, eds., 2002.New Tools for Environmental Protection,Washington, D.C., National Academy Press

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WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARSLee H. Hamilton, President and Director

BOARD OF TRUSTEES

Joseph B. Gildenhorn, Chair David A. Metzner, Vice Chair

PUBLIC MEMBERS

James H. Billington, The Librarian of Congress; Bruce Cole, Chairman, NationalEndowment for the Humanities; Michael O. Leavitt, The Secretary, U.S. Department ofHealth and Human Services; Condoleezza Rice, The Secretary, U.S. Department of State;Lawrence M. Small, The Secretary, Smithsonian Institution; Margaret Spellings, TheSecretary, U.S. Department of Education; Allen Weinstein, Archivist of the United States

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The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in April 2005 by the WilsonCenter and The Pew Charitable Trusts. It is dedicated to helping business, governments, andthe public anticipate and manage the possible human and environmental implications ofnanotechnology.

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CONT

ENTS

Preface

Executive Summary

About the Author

Characteristics of Nanotechnology1. Defining NT2. Rapid Development3. Lack of Effects Data

Existing Regulatory Authorities1. Toxic Substances Control Act (TSCA)2. Occupational Safety and Health Act (OSHAct)3. Food, Drug, and Cosmetic Act (FDCA)4. Environmental Laws – CAA, CWA, RCRA5. Other Laws

Applying Existing Authorities1. Coordinating Mechanisms2. Amending Existing Laws 3. Strengthening Existing Laws

A New Law 1. Description2. Advantages and Disadvantages3. Other Options

Incentives for Environmentally Beneficial Technology1. Research 2. Tax Breaks3. Acquisition Programs4. Regulatory Advantages

New Institutional Capabilities 1. International Harmonization2. Foresight capability3. Research4. Public Participation

Bibliography

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III.

IV.

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