NANOTECHNOLOGY - · PDF filein nanotechnology research,2 not very much is being spent on ......

Project on EmergingNanotechnologies

Project on Emerging Nanotechnologies is supported by THE PEW CHARITABLE TRUSTS

Andrew D. Maynard

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

T 202.691.4000F 202.691.4001www.wilsoncenter.org/nanowww.nanotechproject.org

Project on Emerging Nanotechnologies

NANOTECHNOLOGY:A Research Strategy

for Addressing Risk

PEN 3JULY 2006

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

PRIVATE CITIZEN MEMBERS

Carol Cartwright, Robin Cook, Donald E. Garcia, Bruce S. Gelb, Charles L. Glazer, TamiLongaberger, Ignacio E. Sanchez

The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in 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.

THE PEW CHARITABLE TRUSTS serves the public interest by providing information, advancingpolicy solutions and supporting civic life. Based in Philadelphia, with an office inWashington, D.C., the Trusts will invest $204 million in fiscal year 2006 to provide organi-zations and citizens with fact-based research and practical solutions for challenging issues.

The WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS is the living, national memo-rial to President Wilson established by Congress in 1968 and headquartered inWashington, D.C. The Center establishes and maintains a neutral forum for free, open andinformed dialogue. It is a nonpartisan institution, supported by public and private funds andengaged in the study of national and international affairs.

CONTENTSAcknowledgements

ForewardExecutive Summary

Setting the SceneA Reason for Caution

Rethinking exposure and toxicityNew risks require new research

Why nanotech boosters should fear a dearth of risk researchNanoechnology Research and Develpment in the U.S..

A short history of the National Nanotechnology InitiativeEnvironmental, safety and health research

within the National Nanotechnology InitiativeCurrent federal government investment in ES&H research

Connecting research activities with research needsDeveloping a Strategic nanotechnology Risk Research Framwork

An immediate short-term research strategy is neededIdentifying and prioritizing research needs

Nanotech environment, safety and health research needsPrioritizing research

Overarching objectives for prioritizationPrioritizing research - a ten-year perspective

Short-term research prioritiesImplementing a strategic research frameworkResponsibility for a strategic research framework

Components of a government-led strategic research frameworkWhat might a short-term strategic research plan look like?

SummaryRecommendations

135710101213151517

18212323242427272830323233343940

The opinions expressed in this report are those of the author and do not neces-sarily reflect views of the Woodrow Wilson International Center for Scholars orThe Pew Charitable Trusts.

NANOTECHNOLOGY:A Research Strategy for Addressing Risk

Andrew D. Maynard Ph.D.Chief Science Advisor

Project on Emerging NanotechnologiesWoodrow Wilson International Center for Scholars

PEN 3 JULY 2006

1

This report draws extensively on conversations and correspondence with colleagues across thefield of nanotechnology, and I am grateful for their candor and insight, which has helped formthe ideas and recommendations presented. I am also indebted to Matthew Davis for helpingto ensure the report is accessible and informative.

Acknowledgements

3

1. Lux Research, How Industry Leaders Organize For Nanotech Innovation, Lux Research Inc., New York, NY, (2006) 2. Lux Research, The Nanotech Report, 4th Edition, Lux Research Inc., New York, NY, (2006)3. Duke,W. In Government Executive (Washington, DC, 46–52) (June 15, 2006)

With Lux Research reporting over $32 billion worth of products incorporating nan-otechnology sold in 2005, we still know little about the potential risks, and how theyshould be managed.1 Despite a current annual worldwide investment of over $9.6 billionin nanotechnology research,2 not very much is being spent on investigating what is safeand what is not. With a sound, science-based and sensible research strategy, we can pro-vide nano-businesses—large and small—with the tools they need to identify and reduceor remove possible dangers to health and the environment. But without the right researchplan and investments, the safety and sustainability of emerging nanotechnologies is uncer-tain at best.

The United States government has been a key driver of nanotechnology innovationthrough the National Nanotechnology Initiative (NNI). It has spent billions of dollars toencourage the development and use of nanotechnology in practical, commercial applica-tions. And yet, the risk research underpinning this investment is weak.

As noted in this report, according to a 2005 study presented by the Project on EmergingNanotechnologies, funding of “highly relevant” nanotechnology risk research is just one per-cent of the annual NNI budget—totaling just an estimated $11 million in 2005.

This number increases to about $30 million when research generally relevant to healthand safety issues is included. But this is below the $40 million that the NNI claims is beingallocated yearly on research looking at risks as it is strictly defined by the Office ofManagement and Budget.3 It also is far short of the NNI assertion that more like $100 mil-lion annually is being spent on risk research, if you consider other parts of the govern-ment’s research portfolio which the NNI argues—but does not document—is relevant tounderstanding nanotechnology’s implications.

More important than the level of funding is the fact that the government’s research intothe environmental, safety and health implications of nanotechnology lacks strategic direc-tion and coordination. As a result, researchers are unsure about how to work safely withnew nanomaterials, nano-businesses are uncertain about how to develop safe products, andpublic confidence in these emerging applications is in danger of being undermined.

Foreword“Are nanotechnology products safe?” is a question that is not going away. It is being askedwith increasing frequency by journalists, environmental and consumer groups, scientistsand engineers and increasingly by the public. Nanotechnology innovations are made pos-sible because researchers have learned how to deftly manipulate matter at the atomic level,opening the way for the creation of a vast array of new materials and products possessinga variety of novel and exciting properties. However, many of the same novel properties thatgive nanotechnologies the capacity to transform medicines, materials, and consumer prod-ucts, may also present novel risks.

Clearly, a strategic framework is needed for risk-based research, and it is needed now. Arecent inventory developed by the Project on Emerging Nanotechnologies indicates thatapproximately 300 nanotechnology-enabled consumer products identified by companiesfrom 15 countries are presently on the market.4 Currently, there also are an estimated 600nanotechnology raw materials, intermediate components, and industrial equipment itemsused by manufacturers.

This report is a first attempt to offer a blueprint for systematically exploring the poten-tial risks of nanotechnology. Drawing from previously published scientific papers andreports, it identifies critical research gaps and develops a framework within which effectiverisk-based research can proceed over the next two years and beyond. It makes recommen-dations on what research should be done and who should lead the research efforts.

The paper calls for two major changes in the status quo, specifically:

Leadership. A shift in leadership and funding for risk research to federal agencies that havea clear mandate for oversight and for research of environment, safety and health issues (suchas the National Institute for Occupational Safety and Health [NIOSH], and theEnvironmental Protection Agency [EPA]).

Funding. An estimated minimum federal investment of $100 million over the next twoyears devoted to highly relevant, targeted risk-based research. According to the Project’sdata, this would require a $40 million annual increase over what is currently spent and sig-nificant increases in the research budgets of agencies like NIOSH, EPA, and the NationalInstitute of Environmental Health Sciences (NIEHS).The amount of federal monies allo-cated beyond the initial two years would depend on the strategic framework developed andadopted by the government, and its ability to form risk research partnerships with businessand other countries.

Nanotechnology is moving forward, and it is moving fast.We no longer have the luxu-ry of waiting for risks to appear in the workplace or marketplace before beginning ourresearch.We must ensure that adequate research is funded, and that it is the right researchdone at the right time, if we are to develop safe, sustainable nanotechnologies.This paperprovides a starting point to do just that.

David RejeskiDirector, Project on Emerging Nanotechnologies

4

4. Project on Emerging Nanotechnologies: A Nanotechnology Consumer Products Inventorywww.nanotechproject.org/consumerproducts.Accessed June 2006

Emerging nanotechnologies are unlikely to succeed without appropriate research intounderstanding and managing potential risks to health, safety and the environment. Despitecurrent research, significant knowledge gaps exist in all areas of nanotech risk assessment.

These gaps will be filled only through targeted and strategic research. This reportaddresses the current state of nanotechnology risk research and what needs to be done tohelp ensure the technology’s safe development and commercialization.A strategic researchframework is developed that identifies and prioritizes what the author believes are thecritical short-term issues. Recommendations are made on how a viable strategic researchplan might be implemented.

Changes need to be made in risk research responsibility within the federal government.The report’s principal conclusions are that the federal government needs to assume top-down, authoritative oversight of strategic risk-based research, and that nanotechnology riskresearch should be carried out by federal agencies with a clear mandate for oversight and forresearch of environment, health and safety issues.

Adequate funding must be provided for highly relevant risk research. The appropriateagencies to lead risk research—which include the Environmental Protection Agency (EPA),the National Institute for Occupational Safety and Health (NIOSH), the National Institutesof Health (NIH) and the National Institute of Standards and Technology (NIST)—willrequire an estimated minimum budget of $100 million over the next two years devoted tohighly relevant, targeted risk-based research, if critical knowledge is to be developed.Thisshould be supported by a complementary and identifiable investment in basic research andapplications-focused research that has the potential to inform our understanding of risk.Mechanisms should be developed to make full use of this complementary research.

Short-term research priorities. Over the next two years, nanotechnology risk researchshould focus on ensuring the safety of technologies already in use or close to commercial-ization.Top priorities should include identifying and measuring nanomaterials exposure andenvironmental release, evaluating nanomaterials toxicity, controlling the release of and expo-sure to engineered nanomaterials and developing “best practices” for working safely withnanomaterials.There should also be a strong research investment in longer-term issues suchas predictive toxicology.

Mechanisms are needed for joint government-industry research funding. Governmentresearch funding should be leveraged with joint-industry funding within a strategic risk-research framework.The Health Effects Institute—which has successfully addressed partic-ulate pollution through joint government-industry funding—should be considered as a pos-sible model for addressing nanomaterials risk.

Executive Summary

5

International coordination is essential. Ways of coordinating research activities, sharing costsand exchanging information between countries and economic regions should be explored.

A new interagency oversight group is needed. Development and oversight of a fully fund-ed strategic research plan will require a new interagency group to be established.This groupshould have the authority to set and implement a strategic research agenda and assure agen-cies are provided with appropriate resources.

Long-term research needs and strategies should be assessed on a rolling basis. Finally, anindependent study effort should be established to identify future research needs, provideadvice on how to incorporate them into a strategic research framework and evaluate progresstowards achieving strategic research goals.

6

7Nanotechnology: A Research Strategy for Addressing Risk

Nanotechnology has become something of acatch-all phrase for an incredible variety ofinnovations that are being incorporated intoa wide range of applications—cosmetics, carparts, drugs, food packaging, sports equip-ment and electronics, to name but a few.Specific nanotechnologies can be vastly dif-ferent in form, function and implementation,but they share one common feature: all takeadvantage of a new (or at least greatlyimproved) ability to manipulate physicalmatter down to the atomic level. Scientistsare now able to arrange atoms and moleculesinto precise configurations almost as if theywere using a child’s building blocks.

For example, scientists have constructedcarbon “nanotubes” that are only about ananometer—one-billionth of a meter—indiameter, which is tens of thousands of timessmaller than the width of a human hair.These nanotubes possess unusual properties,such as incredible strength and the ability toconduct heat and electricity, that appear tomake them ideal for improving everythingfrom televisions and tennis rackets to solarcells and water filters.

Nanotechnology, “the new industrial revolution”Nanotubes are just one of many innovationspercolating in the world of nanotechnology.There are nanometer-sized particles(nanoparticles) being developed that couldgreatly improve pharmaceuticals becausetheir size, structure and behavior can be usedto combat illnesses beyond the reach of con-ventional drugs. Nanometer-scale materials(nanomaterials) that can repel stains or killbacteria are being built into clothing fabric.Food companies are experimenting with

nanoparticles that can be incorporated intopackages to detect spoilage or pathogens.Cosmetics companies have developed prod-ucts with nanoparticles that, because of theirmicroscopic size and novel properties, allowsunscreens and moisturizers to perform bet-ter. And these are just some of the currentand near-to-market applications. Becausenanotechnology gives us the tools to dothings differently, the list of potential applica-tions is almost endless. For example, the nextfew years will see nanotechnology leading tostronger, lighter materials in cars and air-planes, high performance batteries, cheapsolar cells, highly efficient water filtration anddesalination processes, and smaller, more sen-sitive sensors. Overall, experts estimate thatinnovations sparked by various types of nan-otechnology will soon encompass a globalmarket in goods and services worth $1 tril-lion. Clearly, today, small is big.

But as the public and private sectors inthe U.S. and, increasingly, the rest of theworld, invest billions into what many nan-otechnology boosters like to call “the newindustrial revolution,” it is fair to askwhether there are any perils in what is usu-ally portrayed as an area of limitless promise.After all, if this is the new industrial revolu-tion that some claim, it might be worthreflecting on the hazards that emerged in thewake of the first industrial revolution.

New technologies mean different risksWhile on balance they have greatly raisedour living standards, industrial processes cancause harm. Witness such problems as“brown lung” among textile workers, pul-monary illness caused by asbestos exposure

Setting the Scene

and air pollution, environmental damagefrom acid rain, and the wide variety of can-cers linked to industrial chemicals and emis-sions.There is no reason to assume that nan-otechnology will be different from otherindustrial innovations when it comes to hav-ing the potential to present both benefits andrisks to human and environmental health.

While there has not been much researchinto risks posed by the many implementa-tions of nanotechnology, there has beenenough to reasonably conclude that there aresome applications that will present problems.For example, carbon nanotubes can causelung inflammation and granulomas in ani-mals, and some nanoparticles seem to bemore harmful mass-for-mass than their larg-er counterparts. While not intended as analarmist statement, the fact remains that cer-tain applications of nanotechnology willpresent risks unlike any we have encoun-tered before. Saying they will be differentdoes not mean they will be more threatening.This discussion of risks is not intended togive credence to sensational fears of nan-otechnology, such as the science-fiction fan-tasy of self-replicating nanobots or “greygoo” taking over the world. But acknowl-edging that nanotechnology presents newkinds of risks means that we need reliableinformation to understand what the realdangers are—from the insignificant to thelife threatening—and to learn how they canbe minimized.

One reason that each week seems to bringanother breakthrough application of nan-otechnology is that scientists have movedbeyond conventional capabilities and into abrand new world of making industrial mate-rials and substances. But these same newprocesses that so excite public and private sec-tor scientists also challenge our conventional

understanding of threats to safety and healthand how to manage them.

Understanding risk through researchIf there is a silver lining in our past experi-ence with industrial hazards, it is that wenow know that an important first step insafeguarding the public from such threats isto invest in objective research that can prop-erly define the nature of the risk. Everyday,in a variety of situations, hazardous chemi-cals and materials are used safely because wehave invested in the scientific research thatshows us how to avoid their dangers. Mostlikely, the risks of nanotechnology also canbe safety managed, if we understand whatthose risks entail.

But today, while billions are being invest-ed by government and industry to quicklycapitalize on the commercial potential ofnanotechnology, there seems to be littleinterest in uncovering and exploring poten-tial risks. One reason for the lack of attentionis a view often expressed in both the publicand private sectors—that nanotechnologydoes not present a new set of dangers, and ifthreats do emerge, we have the regulatoryreview and safety oversight systems in placeto protect the public from harm.

Of course, this begs the question: how canwe be confident that nanotechnology appli-cations are likely to be safe and any threatsthat emerge will be manageable when therehas been so little research exploring risks?

For example, it appears it appears thatonly one percent of the billions of dollars theU.S. federal government has invested in nan-otechnology research has focused directly onexploring risks. Yet hundreds of productsincorporating nanotechnology innovationsalready are on the market and over the next

8

few years, thousands of additional applica-tions are expected to be unveiled.

Today, there are those who dismiss anyconcerns about nanotechnology as the mus-ings of “Luddites” who harbor irrational fearsof technology in general. But, in fact, anyonewho wants to see nanotechnology achieve itsfull potential has a vested interest in theestablishment of a comprehensive nanotech-nology risk research program. A thoroughand open exploration of nanotechnology’spotential threats to humans and the environ-ment is the best way to keep concerns aboutnanotechnology rooted in objective, scientif-ic review. Without such data, the promotersof nanotechnology will have difficultyresponding effectively to even the most out-landish statements about nanorisks.

This paper explores the need to developa better understanding of the risks present-ed by nanotechnology in all its diversity, andhow to develop a responsible approach torisk research. Essentially, it considers thequestion of what to do and how to do to it,to support “safe” nanotechnology.1 It repre-sents one scientist’s personal perspective, andis aimed at stimulating discussion onresearch prioritization and the implementa-tion of a strategic research agenda. In partic-ular, it focuses on short-term research needsthat are critical to assessing and managingrisks associated with nanotechnologiesalready on the market, or on the cusp ofcommercialization.


1.“Safe” is used here as a relative term—“Safe” nanotechnology refers to nanotechnology where the possible riskof harm to people and the environment is understood and minimized.

10

A Reason for CautionWhen it comes to considering a risk researchprogram focused specifically on nanotech-nology, we need to ask the question: shouldwe anticipate that certain applications ofnanotechnology will introduce risks that aresubstantially different from those weencounter with conventional products? Theanswer appears to be yes.The complexity ofengineered nanomaterials means that theirimpact will depend on more than chemistryalone. Size, shape, surface chemistry and sur-face coatings (for example) can all influencehow these materials behave. In some cases,the microscopic size alone of nanoparticlesmight allow them to more easily enter andaffect human organs. In other instances, thefact that nanoscale materials can have unusu-al properties—properties that do not con-form to “conventional” physics and chem-istry—may influence the potential for risks.Indeed, the dependency of nanomaterials’properties on chemistry and structure hasprompted one commentator to call for newproduct-based nano-regulation that isresponsive to this distinction.2

Of course, it is often argued that by theirvery nature, engineered nanomaterials willonly be produced and used in minute quan-tities and that exposures will be insignificant.This possibly is true for new nanotechnolo-gies in their infancy. However, putting asidethe question of what “insignificant” means

(and so far there has been no general con-sensus), commercially successful nanotech-nologies will depend on producing andusing sizeable quantities of materials. The2004 Royal Society and Royal Academy ofEngineering report anticipates that the quan-tities of engineered nanomaterials in use willincrease rapidly over the next few years, withan estimated production rate of 58,000 met-ric tonnes per year between 2011–2020(Figure 1).3 It is sobering to think that, if (aswe suspect) the number or surface of parti-cles making up these materials determinesthe hazard they represent, the impact ofthese materials might be the equivalent ofbetween 5 million and 50 billion metrictonnes of conventional materials.4

Rethinking exposure and toxicityWhen it comes to potential hazard, size canmatter. Compared to conventionally sizedparticles, certain nanoparticles may move eas-ily into sensitive lung tissues after inhalation,and cause damage that can lead to chronicbreathing problems.5 There is also evidencethat some nanoparticles may be able to movefrom the lungs into the bloodstream.Although it is not fully clear what happens ifa nanoparticle goes from the lungs into theblood, we do know that larger inhaled parti-cles do not normally get into the blood-stream. The possibility that nanoparticles

2. Davies, J. C., Managing the Effects of Nanotechnology,Woodrow Wilson International Center for Scholars, Projecton Emerging Nanotechnologies,Washington DC, (2006) 2006–1

3. Nanoscience and Nanotechnologies: Opportunities and Uncertainties,The Royal Society and The Royal Academy of Engineering, London, UK, (2004)

4. Comparing a “conventional” material made up of 2 µm diameter particles, to a nanomaterial comprised of 20 nm diameter particles, and assuming that hazard is associated with either particle number or surface area, not mass.

5. Ferin, J. & Oberdörster, G., Journal of Aerosol Medicine-Deposition Clearance and Effects in the Lung (1992) 5 (3), 179–187

might have an easy route to the body is thekind of nanorisk that deserves more study.6

It is also known that some nanoparticlesare small enough to get inside cells. In fact,both food and drug companies are looking atthe ability of nanoparticles to significantlyenhance the biological activity of foods andmedicines precisely because they can deliverdrugs and nutrients to parts of the body theypreviously could not reach. But there is someevidence that when certain types of particlespenetrate cells, they can cause damage.7

Some substances and materials at thenanoscale also may exhibit new propertiesthat make them more harmful than they

would be at a more conventional size. Forexample, in one study, scientists were sur-prised to find that rats died a mere 30 min-utes after being exposed to an amount ofnanosized particles that, if the material werein a more conventional form, would be con-sidered a safe daily dose.8 It appears that boththe size of the particles and the changes intheir “surface chemistry” that occurred intheir diminutive state made the nanosizedmaterials much more toxic than the largerform of the same material.

In this case, the finding was a serendipi-tous discovery.The researchers did not set outto evaluate nanotechnology risks. And while


FIGURE 1. ESTIMATED ANNUAL GLOBAL PRODUCTION RATESFOR ENGINEERED NANOMATERIALS

Values are based on estimates in the 2004 Royal Society and Royal Academy of Engineering report on nanotechnology.9 They are intended for guidance only, as validated figures are commercially confidential.

6. Ibid., ; Oberdörster, G. et al., J.Toxicol. Env. Health Pt A (2002) 65 (20), 1531–15437. Li, N. et al., Environ. Health Perspect. (2003) 111 (4), 455–460; Oberdörster, G. et al. in American Toxicological

Society (Orlando, Fl, 2004).8. Oberdörster, G., Gelein, R. M., Ferin, J. & Weiss, B., Inhal.Toxicol. (1995) 7, 111–1249. Nanoscience and Nanotechnologies: Opportunities and Uncertainties,The Royal Society and The Royal Academy of

Engineering, London, UK, (2004)

0

10000

20000

30000

40000

50000

60000

Present 2005–2010 2011–2020

Structural ApplicationsSkincare ProductsInformation & Communication TechnologyBiotechnologyInstruments, Sensors & CharacterizationEnvironmental Applications

1000 Tonnes 2300 Tonnes

58,000 Tonnes

Estim

ated

Glo

bal P

rodu

ctio

n Ra

tes

(met

ric to

nnes

per

yea

r)

the particles that killed the rats are not beingconsidered for any commercial applicationsof nanotechnology, the results still shouldserve as a warning that we may get somerude surprises if risks are not aggressivelyexplored early on.

Beyond possible impact on human health,engineered nanomaterials present us withmany challenges to understanding and manag-ing environmental impact. Many nanomateri-als are highly durable, meaning that they willremain in the environment long after theproducts they are used in are disposed of.Could this longevity lead to unanticipatedaccumulation in and harm to the environ-ment? Even nanomaterials that are harmless tohumans might affect other species—possiblyupsetting delicate ecological balances. For

instance, the increasing use of silver nanopar-ticles as an antimicrobial agent is raising con-cern over possible harm to beneficial microbesin the environment. And materials enteringthe bottom of the food chain have a habit ofaffecting organisms—including people—much higher up the chain.We certainly knowfrom experience that the unanticipated impactof apparently “safe” materials on the environ-ment can be significant, if not caught early on.

New risks require new researchOverall, we know enough about the poten-tial risks posed by nanotechnology to under-stand that there are at least some nano-mate-rials and products that pose a different risk tohuman health and the environment com-pared to conventional materials.10 However,

12

These timelines provide a somewhat subjective indication of when relevant research (dashed lines) and whencommercialization (solid lines) is anticipated. Based on Roco (2004).11

FIGURE 2. NANOTECHNOLOGY IMPLEMENTATION AND DEVELOPMENT

PassiveNanostructures

• Nanoparticles

• Nanotubes

• Nano-composites

• Nano-coatings

• Nanostructuredmaterials

1stGeneration

1st Gen

2nd Gen

4th Gen

2000 2010 2020 2030 2040

ActiveNanostructures

• Electronics

• Sensors

• Targeteddrugs

• Adaptivestructures

2ndGeneration

Systems ofnanosystems

• Guidedmolecularassembly

• 3D networking

• Robotics

• Supra-molecules

3rdGeneration

Molecularnanosystems

• Molecules‘by design’

• Hierarchicalfunctions

• Evolutionarysystems

4thGeneration

3rd Gen

10. Maynard,A. D. & Kuempel, E. D., Journal Of Nanoparticle Research (2005) 7 (6), 587–614; Maynard,A. D., NanoToday (2006) 1 (2), 22–33; Oberdörster, G., Oberdörster, E. & Oberdörster, J., Environ. Health Perspect. (2005) 13(117), 823–840

11. Roco, M. C., AIChE. J. (2004) 50 (5), 890–897

we currently lack information to conductthe most basic risk analysis for simple (orfirst generation) nanomaterials. Even less isknown about later generation nanomateri-als now under development that mayinvolve more complicated assemblages ofmolecules and may be far more powerful interms of their abilities, for good or for ill,to affect humans and the environment(Figure 2).

Relying on existing knowledge toquantify the risks of engineered nanomate-rials will engender false assumptions ofsafety.We need to think differently about atleast some of these new materials and sub-stances if we are to identify and managetheir safe introduction into commercialmarkets.12 With the rush in so many sectorsto take advantage of the innovations ofnanotechnology, it is a given that riskresearch inevitably will lag behind productdevelopment. But the goal at the momentshould be to narrow what is now a widegap between current and emerging com-mercial applications, and knowledge oftheir potential hazards.

The dearth of information on risks isparticularly troubling because so many ofthe early applications of nanotechnology areby-design intended to achieve high expo-sure. About a third of the hundreds of nan-otechnology-related consumer productsnow on the market are intended to beingested, or applied to the skin.13 In fact, thefood and cosmetic industries are arguablymoving as fast or faster than any other sec-tor to reap the benefits of nanotechnology.

Most of these innovations likely will turnout to be relatively safe. Nonetheless, fewappear to have come to market supported byindependent research that specifically exploresnano-related risks.And there is no indicationat the moment that we are asking the rightquestions about future applications. As wasnoted before, existing knowledge of suchthings as toxicity, exposures and particle haz-ards will be insufficient for anticipating therisks posed by some nanotechnology applica-tions. Yet government regulators expect toreview and approve nanotech innovationswith the same processes and benchmarks usedto assess the safety of conventional products.Do we really want a situation where the defacto approach to health and safety of nan-otechnology is “put the products on the mar-ket first and answer questions later”?

Why nanotech boosters shouldfear a dearth of risk researchThe inattention to nano-specific riskresearch puts more than consumers and theenvironment in danger. It also sets up a sce-nario in which the future promise of nan-otechnology could suffer serious set-backs,as what could have been predictable andpreventable problems instead emerge asmarket-jarring surprises.

The industry recently got a taste of thisscenario when a German company wasforced to recall an aerosol version of its glassand tile sealant, Magic Nano, after numerousreports that people using it suffered breathingproblems, some serious enough to requirehospitalization.14 It appears now the product


12. Maynard,A. D., Nano Today (2006) 1 (2), 22–33; Maynard,A. D. & Kuempel, E. D., Journal Of NanoparticleResearch (2005) 7 (6), 587–614; Oberdörster, G., Oberdörster, E. & Oberdörster, J., Environ. Health Perspect.(2005) 13 (117), 823-840; Oberdörster, G. et al., Part. Fiber Toxicol. (2005) 2 (8), doi:10.1186/1743-8977-2-8

13. Project on Emerging Nanotechnologies, Consumer Products Inventory. www.nanotechproject.org/consumer-products.Accessed June 2006.

14.Weiss, R. In Washington Post (Washinghton, DC,April 06) A02; von Bubnoff,A. In Small Times (Ann ArborMI,April 14)

did not contain nanoparticles (as was initiallysuspected) and it is not completely clear whatkind of nanotechnology, if any, was used in thespray.15 Nevertheless, Magic Nano went on themarket widely promoted as a nanotechnologyinnovation.No one in government or industrysought to verify the claim, or require evenrudimentary safety data that would showwhether it involved an application of nan-otechnology that might cause harm.

Now, almost every mainstream news storyon nanotechnology prominently features theproblems with Magic Nano as a cautionarytale from the cutting edge. For example, arecent front-page article in the Los AngelesTimes called it “a case that highlights themurky definitions and poorly understoodrisks in one of the fastest-growing segmentsof science and technology.”16

The next five years will bring a torrent ofnew nanotechnology applications to mar-ket. By putting almost all of their invest-ments in product development without

anything approaching a sufficient hedge inrisk research, governments and industriesare making a high stakes bet that nanotechwill be largely devoid of problems, despitethe evidence that nanotechnology couldinvolve a range of poorly understood andsignificant hazards.

As yet, there is no well-documented evi-dence of ill health or environmental harmresulting from encounters with engineerednanomaterials. This fact, however, could bemisleading, as appropriate surveillance hasnot been in place, and commercial applica-tions—particularly of the more advancednanotechnology innovations—are still notwidespread.The prudent way forward, even ifone wants to assume products generally willbe safe, is to develop strategies and frame-works that identify and address potential risksthat, if overlooked, could end up imperilingpeople, harming the environment and doinggreat harm to industry.

14

15. von Bubnoff,A. In Small Times (Ann Arbor MI, May 26) 16. Piller, C. In Los Angeles Times (Los Angeles, CA, June 1)


Any effort to craft a rational and compre-hensive approach to nanotechnology riskassessment must be rooted in a thoroughunderstanding of the existing researchframework that has been so influential inthe evolution of nanotechnology, from lab-oratory curiosity to transformative technol-ogy in the industrialized world.

The advancement of nanotechnology inthe United States—and some would say theworld—has been led by the U.S. NationalNanotechnology Initiative (NNI). Formed in2001 under the Clinton Administration, theNNI has been highly successful in promotingnanotechnology as a multidisciplinary conceptfor stimulating research, commercializationand economic growth. Although primarilyestablished to encourage and coordinate basicand applied research, the NNI now serves asthe nexus of all government-funded nan-otechnology work and is supposed to betracking research into understanding andmanaging potential risks. But compared to itsefforts to encourage commercial applicationsof nanotechnology, the NNI’s approach torisks has been somewhat unfocused and unen-lightening, raising questions about whether aprogram whose primary mission is to pursuethe economic benefits of nanotechnology willgive safety issues proper consideration.

In other words, there is no question thatthe NNI has been of enormous value inmaking nanotechnology research a priority

within the government’s science portfolio.But from both a philosophical and organiza-tional standpoint, is it positioned to explorethe risks of nanotechnology as aggressively asit does the benefits? Or in such a forum, doesrisk research become something of an after-thought, a box to be checked on the road torealizing nanotech’s considerable benefits? Toanswer these questions, one must first under-stand the history of the NNI.

A short history of the NationalNanotechnology InitiativeThe NNI has its roots in an informal initia-tive that was established as a way to shareinformation and coordinate nanotechnolo-gy-related endeavors across a number ofgovernment agencies. In 1996, staff mem-bers from several agencies decided to meeton a regular basis to discuss their nanotech-nology plans and programs.17 In 1998, thisinformal group became the InteragencyWorking Group on Nanotechnology(IWGN) of the President’s National Scienceand Technology Council (NSTC). In 1999,the IWGN published its vision for nan-otechnology research and development forthe next 10 years.18 In a supporting letter,Neal Lane, then assistant to the president forscience and technology, underlined the longterm scientific and economic goals of nan-otechnology Research and Development(R&D) within the U.S. government, stating:

Nanotechnology Research andDevelopment in the United States

17. National Academies, Small Wonders, Endless Frontiers.A Review of the National Nanotechnology Initiative, NationalAcademy Press,Washington, DC, (2002)

18. Nanotechnology Research Directions: IWGN Workshop Report.Vision for Nanotechnology R&D in the Next Decade,National Science and Technology Council Committee on Technology Interagency Working Group onNanoscience, Engineering and Technology (IWGN),Washington DC, (1999)

“Nanotechnology Research Directions willhelp our nation develop a balanced R&Dnanotechnology infrastructure, advancecritical research areas, and nurture the scien-tific and technical workforce of the nextcentury.”19

At the time, the IWGN included repre-sentatives from the Executive Office and nineagencies, including the Departments ofCommerce, Defense, Energy, Treasury, andTransportation, along with the Enviro-nmental Protection Agency, the NationalInstitutes of Health, the National ScienceFoundation, and the National Aeronauticsand Space Administration.

Two years later, the Clinton administra-tion, seeking a higher profile for nanotech-nology, officially launched the NNI. TheNSTC established a new Nanoscale ScienceEngineering and Technology (NSET) sub-committee to oversee the NNI, under thechair of NSF’s Dr. Mihail Roco.20

The role of the NNI was formalized andfurther strengthened in 2003 with the sign-ing of the 21st Century NanotechnologyResearch and Development Act.21 The Act laysout the scope of nanotechnology researchand development within the U.S. govern-ment, and includes specific provisions forreview and evaluation. It mentions theimportance of U.S. global leadership in nan-otechnology, advancing U.S. productivity andcompetitiveness, and accelerating the deploy-ment and application of nanotechnologyresearch and development in the private sec-tor.The Act also notes the need for a research

program and interdisciplinary centers thataddress ethical, legal, environmental andother societal concerns.

In 2004, the NNI published a strategicresearch plan that highlights, in addition toapplication-oriented efforts, the need for“responsible development” of nanotechnolo-gy.22 To that end, the NNI calls for researchthat focuses on “(1) environment, health, andsafety implications, and (2) ethical, legal, andall other societal issues.”The official positionof the NNI is that because “technologicalinnovations can bring both benefits and risksto society, the NNI has made research on anddeliberation of these two areas a priority.”

The NNI deserves credit for making riskresearch a part of the program’s strategicgoals. However, there are two barriers thathave kept these goals from being translatedinto a meaningful risk research program.

First, the NNI lacks the authority to com-pel greater investments in risk-relatedresearch. While the NNI is able to facilitateintergovernmental cooperation—and canarticulate overarching goals for nanotechnol-ogy research—as a practical matter, it playsonly an advisory function. It has no authority to set the nanotechnologyresearch agenda for particular agencies, orensure adequate resources are available toachieve specific aims. For example, whileNNI officials may speak publicly about a $1 billion annual NNI R&D budget, in real-ity these funds are allocated by numerouscongressional committees and administeredat the agency level—not through the NNI—

16

19. Ibid.20. NSET currently includes members from agencies involved in the NNI, as well as representatives from the

White House Office of Science and Technology Policy (OSTP), and is administered by the NationalNanotechnology Coordinating Office (NNCO).The subcommittee is currently jointly chaired by representa-tives from OSTP and the Department of Energy.

21. United States Congress, 21st Century Nanotechnology Research and Development Act (Public Law 108-153), 108thCongress, 1st session.,Washington DC, (2003) S.189

22. NSET, The National Nanotechnology Initiative Strategic Plan, National Science and Technology Council, (2004)


23. Ibid.; The National Nanotechnology Initiative. Research and Development Leading To a Revolution in Technology andIndustry. Supplement to the President’s FY2006 budget, Nanoscale Science Engineering and Technology subcom-mittee of the NSTC,Washington DC, (2005)

24.The National Nanotechnology Initiative. Interagency Working Group on Nanotechnology Environmental and Health Implications (NEHI WG), www.nano.gov/html/society/NEHI.htm.Accessed June 2006.

and are invested in the service of agencyagendas, not the NNI’s strategic plan. In thatsense, the NNI plan and, in particular, its stat-ed commitment to risk research, is more athought exercise than an actual plan for fed-eral investment in nanotechnology R&D.

Second, the NNI has struggled to ade-quately promote risk research as a priority.Just because the NNI has no budget author-ity does not mean it is without influence.Through their regular contacts with agencyofficials, Congress, the broader scientificcommunity, the press and the public, NNIofficials have many opportunities to put thespotlight on neglected areas of nanotech-nology research—such as understandingpotential risk. However, there is little evi-dence of NNI using its influence to signifi-cantly boost the federal investment in andprofile of risk-related endeavors.

Environmental, safety and health(ES&H) research within theNational Nanotechnology InitiativeTo recap, the NNI is an initiative with itsroots in basic and applied research. It wasestablished to serve the economic interests ofthe United States, with little authority toenact a strategic research plan.Yet even withits shortcomings, the NNI offers a vehiclefor pursuing a coordinated federal researchagenda focused on the environmental, safetyand health impacts of nanotechnology. Andit has taken some steps in this direction.

In 2004, following informal agency dis-cussions, the Nanoscale Science Engineeringand Technology subcommittee establishedthe Nanotechnology Environmental and

Health Implications (NEHI) working group.NEHI’s purpose is to coordinate agencyefforts that involve considerations of nan-otechnology risks. The working group pro-vides a forum for agency discussions on riskrelated issues and is supposed to help pro-mote risk-related research as a priority with-in the NNI.23 According to the NNI, theNEHI goals are to:

• Provide for information exchange amongagencies that support nanotechnologyresearch and those responsible for regulationand guidelines related to nanoproducts;

• Facilitate the identification, prioritization,and implementation of research and otheractivities required for the responsible researchand development,utilization,and oversight ofnanotechnology and;

• Promote communication of informationrelated to research on environmental andhealth implications of nanotechnology toother government agencies and non-govern-ment parties.24

These are largely supportive roles, and theworking group has yet to use its forum toplay a leadership role in establishing a strongrisk research program. Like other NNI enti-ties, the working group has no authority tomandate priorities or ensure that particularinitiatives are properly funded by agencies.However, the working group is preparing anevaluation of research needed to addressenvironmental, safety and health implica-tions, that should be complete in mid 2006,

and that may conceivably form a basis forconcerted government action to addressnanotechnology risk research.

Current federal government investment in ES&H researchFederal agencies are investing in nanotech-nology risk-relevant research, and one mustassume that this is coordinated to a certaindegree through the NEHI working group.However, it is difficult to obtain a clear pic-ture of what is being done, and how relevantit is. Initial funding estimates from NNI indi-cated that federal agencies are spending $100million each year on research related to nan-

otechnology risks. But there were criticismsthat this figure included research that was notobviously relevant to understanding risk.26

Using more stringent criteria for identifyingrisk-relevant research, the NNI published arevised estimate in 2005 of $38.5 million peryear.27 No detailed information was releasedon the research being supported by thisfunding however.

Even if the revised NNI figure is an accu-rate reflection of federal spending—and thereis little evidence to show that it is—one stillcannot determine if there is a robust andcoordinated nanotechnology risk researchstrategy, because there is no information on

18

Annual spending estimated from the National Nanotechnology Initiative and the Project on EmergingNanotechnologies (PEN).25 Highly relevant research (right hand column) is specifically focused on health andenvironmental risks associated with engineered nanomaterials, and is included in the broader analysis of allrelevant research (middle column). NNI figures are estimated budgets for October 2005–September 2006,while PEN figures are estimated expenditure for January–December 2005. †Estimate, based on researchwithin the National Toxicology Program. ††Based on aggregated funding. Reported by NNI †††Estimatedfrom the percentage of projects highly relevant to engineered nanomaterials.

Agency

NSF 24.0 19.0 2.5DOD 1.0 1.1 1.1DOE 0.5 0.3 0HHS (NIH) 3.0 3.0 † 3.0 †

DOC (NIST) 0.9 1.0 0USDA 0.5 0.5 0EPA 4.0 2.6 2.3HHS (NIOSH) 3.1 3.1†† 1.9 †††

DOJ 1.5 0 0Totals 38.5 30.6 10.8

PEN-estimated risk-related annual R&D

(all relevant research)

PEN-estimated risk-related annual R&D

(highly relevant research)

NNI-estimated risk-related annual R&D

TABLE 1. U.S. FEDERAL GOVERNMENT ANNUAL SPENDING ON NANOTECH-RISK R&D ($MILLIONS)

25. The National Nanotechnology Initiative. Research and Development Leading To a Revolution in Technology and Industry.Supplement to the President’s FY2006 budget, Nanoscale Science Engineering and Technology subcommittee of theNSTC,Washington DC, (2005); Inventory of Research on the Environmental, Health and Safety Implications ofNanotechnology, Project on Emerging Nanotechnologies,Woodrow Wilson International Center for Scholars,Washington DC, (2005)

26. Stuart, C., Small Times (2006) 6 (2), 22–2327. NSET, The National Nanotechnology Initiative. Research and Development Leading To a Revolution in Technology and

Industry. Supplement to the President’s FY2006 budget, Nanoscale Science Engineering and Technology subcommit-tee of the NSTC,Washington DC, (2005)


28. Nanotechnology. Health and Environmental Implications:An Inventory of Current Research. Project on EmergingNanotechnologies. www.nanotechproject.org/18/esh-inventory.Accessed June 2006.

29. The Nanotechnology Consumer Products Inventory, Project on Emerging Nanotechnologies,Woodrow WilsonInternational Center for Scholars,Washington DC, (2006); Inventory of Research on the Environmental, Health andSafety Implications of Nanotechnology, Project on Emerging Nanotechnologies,Woodrow Wilson InternationalCenter for Scholars,Washington DC, (2005)

what research is being done and what is not.NNI representatives have noted that it is hardto tease out risk-related projects from thegeneral mix of nanotechnology work.However,without a more precise understand-ing of what U.S. government-funded investi-gators are studying, the reported figures tell usnothing about whether the right questionsare being asked—and answered—that willensure nanotechnology’s safe management.

Although the NNI is reticent to providemore details on risk-related research projects,a substantial amount of information is avail-able from funding agencies. In 2005, theProject on Emerging Nanotechnologies(PEN) compiled an inventory of currentgovernment-funded risk-related research.28 In

the absence of clear information from theNNI, PEN sought to collect and categorizeagency-supported research that is relevant tonanotechnology’s risks to humans and theenvironment. Acknowledging that risk-rele-vant work is indeed sometimes embeddedwithin broader efforts, projects were catego-rized as being either generally or highly rele-vant to health and safety issues.The invento-ry is not comprehensive, as a number ofagencies were not forthcoming in providinginformation. It is, however, currently themost comprehensive information source ofits kind.

Comparing PEN’s estimate of federalspending on nanotechnology risk researchwith the NNI’s estimate tells an interesting

FIGURE 3. NANOTECHNOLOGY ES&H RESEARCH FUNDING FOR SIX CLASSES OF ENGINEERED NANOMATERIALS, COMPARED TO CONSUMER PRODUCTS USING THOSE MATERIALS29

$6,300,000

$700,000

$111,000$268,000

$422,000 $100,000CarbonSilverSilicaTitanium (including oxide)Zinc (including oxide)Cerium oxide

34%

30%

17%

9%

9%1%

Annual Research Investment Consumer products based on materals

story. Table 1 compares estimated annualfunding for research which is highly relevantto understanding risk, against research whichhas some degree of relevance. The periodsover which the estimates are based are slight-ly mis-aligned, although there are no indica-tions that there have been major changes infunding levels between 2005 and 2006.

Although the NNI funding estimate pur-ports to represent research highly relevant tounderstanding risk, there is actually a closeagreement between this figure (column 2 intable 1) and the PEN estimate of all researchwith risk-relevance. This includes researchprojects developing nanotechnology applica-

tions, and projects addressing incidentalnanoparticles such as welding fume. The $8million difference between NNI’s $38.5 mil-lion per year estimate and PEN’s $30.6 mil-lion per year estimate could reflect the dif-ferent reporting periods or, more likely,agency reticence to fully disclose the detailsof current research. Differences in account-ing will also influence the comparison—forinstance, NNI-reported EPA funding intable 1 includes investment in risk-focusedresearch grants over a three-year period,while PEN figures just reflect active researchin 2005.

When PEN’s estimate of research that ishighly relevant to engineered nanomaterials iscompared to the NNI estimate, the gapwidens: PEN estimates that approximately$11 million per year is being spent onresearch that is highly relevant to nanotech-nology risks, compared to NNI’s estimate of$38.5 million per year.That gap is too large tobe explained by the different reporting peri-ods or a lack of agency disclosure, and raisesquestions about the validity and the basis ofthe NNI figures.

To recap, a detailed analysis of U.S. gov-ernment-funded research specificallyaddressing the risks associated with nan-otechnology amounts to approximately $11million dollars per year, or about 1% of the$1.06 billion requested in the fiscal year2006 nanotechnology research and develop-ment budget.31

Of further significance is the fact that thetwo government agencies mandated to carryout research in support of protecting humanhealth and the environment (EPA and

20

Lungs (24)

Skin (5)

Central Nervous System (2)Cardiovascular (2)

Gastrointestinal tract (0)

The number of current research projects specificallyfocused on the impact of engineered nanomaterialson five target areas within the body (lungs, skin, car-diovascular system, central nervous system, gastroin-testinal tract).30

FIGURE 4. NANOTECH-RISK RESEARCH PROJECTS ON SPECIFIC AREAS OF THE BODY

30. Inventory of Research on the Environmental, Health and Safety Implications of Nanotechnology, Project on EmergingNanotechnologies,Woodrow Wilson International Center for Scholars,Washington DC, (2005)

31. The National Nanotechnology Initiative. Research and Development Leading To a Revolution in Technology and Industry.Supplement to the President’s FY2006 budget, Nanoscale Science Engineering and Technology subcommittee ofthe NSTC,Washington DC, (2005)

Nanotechnology: A Research Strategy for Addressing Risk 21

32. A Nanotechnology Consumer Products Inventory. Project on Emerging Nanotechnologies. www.nanotechproject.org/consumerproducts.Accessed June 2006

33. The Nanotechnology Consumer Products Inventory, Project on Emerging Nanotechnologies,Woodrow WilsonInternational Center for Scholars,Washington DC, (2006)

NIOSH) only represent around $4 million,or just over one third, of all spending on high-ly relevant nanotech risk research. This natu-rally raises questions about what other agen-cies are doing, and whether this balancebetween different agencies is appropriate. Italso begs the question whether research cur-rently underway is sufficient to answer someof the most critical questions related to nan-otechnology. Again, it is hard to say withoutmore detailed information from the agenciesor the NNI. But it is reasonable to concludethe low investment and the lack of specificsindicate that, at best, strategic, highly relevantrisk-related research has been a low prioritywithin the NNI.

Connecting research activitieswith research needsTwo examples serve to further highlight anapparent disconnect between the approachto risk research within the NNI and what isneeded to illuminate any hazards related tonanotechnology.

The first example draws on anotherinventory compiled by PEN that lists con-sumer products purporting to be based insome way on nanotechnology.32 Figure 3summarizes funding for risk-related researchaddressing six types of nanomaterials, basedon carbon, silver, silica, titanium, zinc andcerium, and compares it to the number ofconsumer products known to be using thesematerials. Although this is a very subjectiveexercise, it shows that most of the riskresearch is focused—disproportionately itwould seem—on carbon-based nanomateri-als. In the consumer products market, car-bon-based nanomaterials account for 34% of

listed products, while silver is used in 30% ofproducts and silica and metal oxides such assilica, titanium dioxide, zinc oxide and ceri-um oxide are uses in 36% of listed products.In other words, risk research does not appearto be in step with current market realities.

The second example considers the num-ber of research projects that are probing thepotential effects of nanomaterials on differ-ent parts of the body—the lungs, the skin,the central nervous system, the cardiovascu-lar system, and the gastrointestinal tract (seeFigure 4). Current human hazard researchappears to focus heavily on nanomaterials inthe lungs (24 projects), while no projects arespecifically addressing the potential effectsof nanomaterials in the gastrointestinal tract.Given the large number of current nano-products that are supposed to be eaten—such as food and nutritional supplements—this is a curious and serious omission.33

These examples indicate that currentfederally funded research is not addressingthe general range of risks that may alreadybe present in the market, and that riskresearch is not guided by a careful consider-ation of needs—present or future. Why isthere so little research on nanomaterials inuse now? Is the emphasis on lung impactdue to careful consideration of relative risks,or because pulmonary toxicologists aremore active in this field?

An apparent disparity between riskresearch, nanomaterials in use and wherethey might impact on the body naturallyleads to the question “are there real gaps inour knowledge that are not being adequate-ly addressed?” And the answer is clearly yes.This document, and the papers it draws on,

is a testament to the vast tracts of nano-riskknowledge that remain undiscovered. Thisessential knowledge will not be developedby chance, but by strategic, targetedresearch. For example, there is little evi-dence that the current nanotechnology riskresearch portfolio will provide rapid answersto questions like:

• Are buckyballs (C60) in cosmetics harmful?

• What are the risks in releasing nano-silver into the environment?

• Do nanomaterials in foods and foodpackaging present a risk?

• Will exposure to engineered nanomaterials lead to ill health?

• What happens to engineered nanomateri-als at the end of a nano-product’s life?

Individual agencies such as NIOSH, EPAand NIH have small research programsaddressing risk. But overall, as a federal gov-ernment initiative that otherwise closely tracksthe federal government’s $1 billion annualinvestment in nanotechnology research, theNNI seems to have something of a blind spotwhen it comes to focusing on risk-relatedresearch.As the NNI coordinates research thatwill help the U.S. realize the benefits of nan-otechnology, one should also expect it toensure that federal efforts protect the publicfrom possible risks.And if the NNI finds thoseefforts are insufficient, it should take the leadin a high-profile push to craft an agenda andpromote the collaborations and partnershipsrequired to develop a thorough understandingof any safety concerns that may emerge fromthis exciting new era of industrialization.

22

Clearly, a strategic research framework is need-ed that will underpin the roll-out of “safe”nanotechnologies. Without proper considera-tion of risk assessment and management needs,it is likely that harmful technologies and prod-ucts will result. And that, in turn, could slowdown product development across the board asregulators and users pause to reconsider poten-tial dangers. But drawing up a blueprint fornanotech risk research will not be easy. In addi-tion to identifying what needs to be done andwhen, a viable risk research framework mustfocus on how resources are allocated and indi-cate how participating organizations and agen-cies should be involved in the decision-makingprocess.The framework also should reflect themultidisciplinary nature of nanotechnology,which crosses established boundaries of scien-tific inquiry and agency jurisdictions.

To function efficiently, such a frameworkshould be overseen and implemented at a veryhigh level. If strategic research plans are devel-oped only at the individual organizational oragency level, risk research would lack the nec-essary breadth, coordination, and authority thatonly an overarching framework can provide.Such a framework for nanotechnology riskresearch should be international in scope.However, a more realistic expectation wouldbe for a national framework that includes thenecessary provisions for full and effective inter-national collaboration and coordination.

An effective risk research framework alsowould address regulatory and oversight needs,

in addition to the generation of new knowl-edge. Ensuring risk research supports the over-sight of nanotechnology requires governmentleadership in establishing a relevant and work-able framework. Nevertheless, an effectiveframework would also incorporate partner-ships and coordination with industry and otherstakeholder groups.

An immediate short-term researchstrategy is neededAdvances in nanotechnology and its imple-mentation are predicted to continue for manyyears,34 and an effective strategic framework forrisk-based research will necessarily need toaddress long-term needs. However, nanotech-nology-based products are a reality now. TheProject on Emerging Nanotechnologies haspublished an inventory listing over 275 nan-otechnology-enabled consumer products.35

These products are seen as the tip of the nan-otechnology-application iceberg. Manyresearchers and nanotechnology industryworkers already are producing and handlingengineered nanomaterials on a day-to-daybasis, with little information on assessing andmanaging risk.36 These products and materialsare being released into the environment(intentionally or unintentionally) with littleunderstanding, at least in some cases, aboutwhat the long-term impacts might be.

Recognizing the urgency with whichcoordinated action is needed, this paper dealsspecifically with short-term strategic research


Developing a Strategic Nanotechnology Risk Research Framework

34. Roco, M. C., AIChE. J. (2004) 50 (5), 890–89735. Project on Emerging Nanotechnologies. A Nanotechnology Consumer Products Inventory. www.nanotechproject.org/

consumerproducts.Accessed June 200636. Maynard,A. D. & Kuempel, E. D., Journal Of Nanoparticle Research (2005) 7 (6), 587–614

needs. It addresses what can and should bedone over the next two years to understandpossible dangers posed by products, processesand materials either in use now or soon to beintroduced. The recommendations that resultaddress immediate needs, while robust long-term research strategies are developed.

Identifying and prioritizingresearch needsOver the past two years, many groups, gov-ernment agencies and organizations havepublished their perspectives on the researchrequired to support safe nanotechnology.However, there have been no attempts to usethis information to develop a strategicresearch plan that identifies critical questionsand asks how and when those questions aregoing to be answered.

This report for the first time presents andanalyzes the recommendations on needed riskresearch contained in nine of the most signifi-

cant published perspectives. In the analysis pre-sented here, the identified research needs areprioritized over a ten-year period, allowingshort-term research requirements to be high-lighted that are informed by immediate needsand longer-term developments. Althoughidentifying research priorities 10 years out issomewhat speculative, it is an exercise thathelps focus on immediate needs, while alsohighlighting longer-term issues that mustbegin to be addressed soon, if we are to stayabreast of emerging nanotechnologies.

Nanotech environment, safety and health research needsThe nine sources of information used for thisanalysis—all published in the past two years—are listed in Table 2.While these sources do notform a comprehensive list on the subject ofrisk and nanotechnology, they do providemany different stakeholder perspectives andrepresent a diversity of scientific opinions.

24

Source Year DocumentA G. A. Oberdörster, A.

Maynard et al.2005

B 2005

C 2005

D 2004

E 2005

F 2005

G 2005

H 2005

I 2005

Environmental ProtectionAgencyU.K. Government

The Royal Society andThe Royal Academy ofEngineeringA. D. Maynard and E. D.KuempelNational Institute forOccupational Safety andHealthEuropean Commission

R. A. Dennison(Environmental Defense)Chemical Industry Vision2020 TechnologyPartnership and SRC

Principles for characterizing the potential human health effectsfrom exposure to nanomaterials: elements of a screeningstrategy. Part. Fibre Toxicol. 2(8): doi:10.1 186/1743-8977-2-8U.S. Environmental Protection Agency Nanotechnology WhitePaper: External Review Draft.

Nanoscience and Nanotechnologies: Opportunities andUncertainties.

Characterizing the Potential Risks Posed by EngineeredNanoparticles. A first U.K. government research report.

Airborne Nanostructured Particles and Occupational Health,Journal of Nanoparticle Research 7(6): 587-614Strategic plan for NIOSH Nanotechnology Research,Draft, September 28, 2005.

Communication from the Commission to the Council, theEuropean Parliament and the Economic and Social Committee.Nanoscience and Nanotechnologies: An Action Plan for Europe2005 –2009.A Proposal to Increase Federal Funding of Nanotechnology RiskResearch To at Least $100 Million Annually.Joint NNI-ChI CBAN and SRC CWG5 NanotechnologyResearch Needs Recommendations.

TABLE 2. SOURCES USED TO IDENTIFY RESEARCH NEEDS

Each of the documents listed in Table 2addresses nanotechnology and risk to someextent, although in each case the perspectiveand aims are different. Taken individually, nosingle document provides a comprehensiveview of what needs to be done to assess andmanage risks. However, taken together, theyrepresent a broad multi-stakeholder perspec-tive on critical risk issues.

Research needs explicitly identified in eachof the nine documents were collected togeth-er. To these were added additional researchneeds that were suggested through a reasonableinterpretation of the text. The research needswere then grouped into distinct categories.This process guided the construction of a list ofclearly-defined research areas and sub-areas.

Table 3 summarizes the informationgleaned from the various sources. Overarchingareas are shown in bold,while component sub-areas are bolded, indented, and italicized. Eachresearch area (left column) is mapped onto thesources where it is highlighted (right columns).For example, the need for exposure research ingeneral is noted in all documents, whereas justtwo sources highlighted the need for researchinto methods for measuring nanomaterials inthe environment.

While the table does not represent anexhaustive analysis of research needs, it pro-vides a valuable starting point for identifyingcritical short-term research issues, and forbeginning to address longer-term strategicresearch.

The analysis yielded 11 overarching cate-gories of research needed:

Human Health Hazard. Research is neededinto how nanomaterials get into and behavewithin the body, and how toxicity can be test-ed for and predicted.

Health Outcomes. Research is needed ondisease resulting from exposure to engineered

nanomaterials within the workforce, the gen-eral population, and sensitive groups such aschildren and the elderly.

Environment. Research is needed on howengineered nanomaterials enter the environ-ment, where they go and how they behaveonce there, the impact they have, and howthey might be controlled.

Exposure. Research is needed to identifysources of engineered nanomaterials expo-sure and how changes in nanomaterials overtime might affect exposure. In particular,research is needed into how exposure shouldbe measured.

Characterization. Research is needed onhow significant characteristics of engineerednanomaterials, such as size, shape, surface areaand surface chemistry, should be measuredwhen evaluating risk.

Control. Research is needed into whereengineered nanomaterials might potentiallyescape into the environment, and ways ofpreventing such escapes. In particular,research into the efficacy of personal protec-tive equipment (including respirators) isneeded, and how to deal with releases whenthey occur.

Risk Reduction. Research is needed into newways of assessing risk, and new ways of work-ing safely with engineered nanomaterials.

Standards. The development of appropriatenanotechnology standards is needed—in par-ticular, standards that develop an appropriatelanguage for describing nanomaterials andstandards for measuring exposure. Standardmaterials are also needed for developing anunderstanding of potential risk, and forbenchmarking toxicity evaluations.


26

TABLE 3. NANOTECH RISK-RESEARCH AREAS THAT NEED ADDRESSING

Role of material physicochemistry

Mechanisms of toxicityBehavior in the body

Routes of entry

Dose

Transport, transformation and fate

Health outcomesHealth impact

EpidemiologySensitive populations

EnvironmentLife cycle analysisDispersion (including sources)Transformation

FatePersistence and bioaccumulationExotoxicology

Toxicity testing

Toxic mechanisms

Environmental control

ExposureSourcesExposure routesExposure metrics Measurement methodsNanomaterials in the environmentNanostructured material behavior

CharacterizationControl

Potential release routes

Engineering control

Substitute materialsPersonal protective equipmentRespirators and filtersProcess/material based controlSpills

Risk reductionRisk assessment

Best practices

StandardsTerminologyMeasurementMaterials

SafetyInformaticsResearch approaches

Research areas

Human health hazardToxicity evaluationScreening tests

EndpointsTesting methods

Predictive toxicology

Structure activity relationships

Computational toxicology

A B C D E F G H I

Sources

Research areas as identified in nine sources (Table 2)

Safety. Research into the potential for engi-neered nanomaterials and nano-products tocause physical harm is needed. In particular,more research is required into explosion andfire hazards.

Informatics. Research is needed into how tocollect, sort and use the vast and diverse amountof data being generated on engineered nano-materials that is relevant to understanding risk.

Research approaches. Research is neededinto how to do research. Put simply, the chal-lenges being faced by some nanotechnologiesare so new that conventional researchapproaches and tools are sometimes not suffi-cient. For example, it is now known that someconventional ways of evaluating toxicity areinappropriate for nanomaterials, requiring newapproaches to be developed.The complexity ofnanomaterials is forcing cross-disciplinary col-laboration across previously rigid scientificdivides, and researchers are having to find newapproaches to working together effectively.

While perhaps not comprehensive, table 3captures most critical areas of research needs.Two areas that were not captured well by thesources used however, but are neverthelessimportant, include:

Transportation. The movement of engineerednanomaterials from one place to another—inraw, intermediate or highly processed forms—will involve specific risks of release, exposureand impact.Research is needed into the poten-tial for release and the exposure hazard for dif-ferent types of material, containment require-ments, hazard labeling, and specific transporta-tion requirements and limitations.

Emergency responders. In the case of an acci-dental release of engineered nanomaterials,emergency response teams will need specific

information on how to respond effectively—and in particular how procedures and protocolsmay differ from incidents involving conven-tional materials. Research is needed to developappropriate advice, guidance and protocols.

Prioritizing researchIdeally, all research needs—from immediate tolong-term—should be prioritized by the sci-ence and policy communities, and should rep-resent the perspectives of multiple stakeholders.This could be a somewhat lengthy process,given the need to consult widely and reviewrecommendations extensively. At the sametime, immediate research is needed to addressconcerns about materials and technologiesclose to commercialization or already in themarket.This report suggests a method by whichcritical short-term needs can be identified andacted on while longer-term research strategiesare developed.

Overarching objectives for prioritizationTo guide prioritization of research needs, twooverarching objectives were used:

• Oversight. Research supporting the devel-opment of risk oversight frameworks, para-digms, and mechanisms that protect humanhealth and the environment as far as ispracticable in the absence of completeinformation, while not unnecessarily sti-fling innovation.

• New Knowledge. Research leading to thedevelopment of new knowledge that willfurther enable risks to be reduced and man-aged appropriately.

Within these objectives, research areas werealigned with immediate, medium-term orlong-term needs, using the following defini-tions as guidelines:


• Immediate needs – Ensuring current nan-otechnologies are as safe as possible, thatappropriate workplace practices for handlingengineered nanomaterials exist and appro-priate ways of using and disposing of nanotechnology-based products areunderstood.

• Medium-term needs – Establishing associationsbetween nanomaterial exposure and diseaseor environmental impact, and developing anunderstanding of how to minimize impact.This research would include human healthoutcomes; ecotoxicity; toxicity screening; riskmanagement systems; control methods; life-cycle assessment; and exposure methods.

• Long-term needs – Developing ways of pre-dicting and preemptively managing thepotential risk of emerging nanotechnolo-gies, including mechanistic toxicology; pre-dictive risk assessment and management oflater generation nanotechnologies; emer-gent behavior and convergence betweendifferent technologies.

Common to all three definitions is anunderstanding that research must relate totechnologies and materials that will be devel-oped in the future (for example, see Figure 1),as well as current nanotechnologies.

Managing risk will be a complex processUnderstanding and managing potential risksassociated with nanotechnologies will be acomplex process. One cannot develop a robustapproach to assessing and managing riskthrough a linear sequence of research whereone project begets another. Rather, many par-allel research threads must be followed simulta-neously to ensure that appropriate knowledgeis developed and applied efficiently. To put it

bluntly, people are being exposed to nanoma-terials now and risk research is playing a gameof catch-up. We do not have the luxury ofresearching every aspect of nanomaterials tox-icity for the next 10 years before proceedingon to research into exposure measurement andcontrol. Therefore, we need to move rapidlywith a comprehensive approach to under-standing the nanotechnology risks that we maybe facing, if we are to have any hope of pre-dicting and managing the impact of new nan-otechnologies 10 years down the line.

Responding to this challenge, the researchprioritization presented here provides my con-clusions about what research should be doneand when. It recognizes that research address-ing long-term needs should be started now butthat research addressing short-term criticalissues should be given a higher priority.

Prioritizing research—a 10-year perspectiveTable 4 provides a visual representation ofresearch priorities over the next 10 years.Following the criteria outlined previously, itreflects shifting priorities over time, fromensuring emerging nanotechnologies are assafe as possible within our current limitedunderstanding, through establishing associa-tions between nanomaterials and health andenvironmental impact, to being able to pre-dict and prevent potential risk farther downthe road.

Table 4 provides an extensive amount ofinformation. At the most basic level, it high-lights research needs “hot spots” (denoted by“hot” colors)—showing what type of researchneeds to be done when over the next 10 years.For instance, research to develop toxicityscreening tests is urgently needed now, whileunderstanding how nanomaterials change inthe environment is something that willbecome more critical in the next two years.

28


Research areas 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Human health hazard Toxicity evaluationScreening tests EndpointsTesting MethodsPredictive Toxicology

Structure Activity RelationshipsRole of material physicochemistryComputational toxicology Mechanisms of toxicity

Behavior in bodyRoutes of entryDoseTransport, transformation and fate

Health outcomesHealth impactEpidemiologySensitive populations

EnvironmentLife cycle analysisDispersion (including sources)TransformationFatePersistence and bioaccumulationExotoxicology

Toxicity testingToxic mechanisms

Environmental controlExposure

SourcesExposure routesExposure metrics Measurement methodsNanomaterials in the environment Nanostructured materal behavior

CharacterizationControl

Potential release routesEngineering controlSubstitute materialsPersonal Protective EquipmentRespirators and filtersProcess/material based controlSpillsContainment & Transportation

Risk ReductionRisk assessmentBest practices

StandardsTerminologyMeasurementMaterials

SafetyInformaticsResearch approaches

High PriorityLow Priority

KEY Anticipated shifts in research priorities are shown year by year. Prioritization beyond2010 is highly subjective, but provides context for short-term research priorities.

TABLE 4. A 10-YEAR NANO-RISK RESEARCH PRIORITIZATION

A personal evaluation of research priorities. Hot/dark colors (red, orange) indicate high priority, while cooler/lighter colors (green, blue) represent lower priorities.

Table 4 also pinpoints when certain areasof research are likely to increase in promi-nence (for instance, the impact on sensitivepopulations like children and the elderly isanticipated to increase in relevance in thenext few years), allowing some degree of for-ward planning in research strategies.

Finally,Table 4 identifies when some areasof research should perhaps be de-emphasized(shown by cooler colors), although this, ofcourse, becomes increasingly speculative thefurther out one goes. An example is researchinto predicting the toxicity of new nanoma-terials—which will become a high priority ina few years’ time, but is superceded by morepressing matters in the short term.

The research priorities beyond 2010 intable 4 are probably too speculative to formthe basis of a long-term strategic researchplan, but do help provide a context forshort-term research needs. However, identi-fied research priorities for 2007–2009 pro-vide a useful basis for highlighting and act-ing on short-term research needs thataddress critical questions, as well as identify-ing research that will increase in relevance incoming years.

Short-term research prioritiesShort-term research needs identified in table 4are listed in table 5.The table is divided intothree categories—immediate research issues,and research that is needed now to beginaddressing medium and long-term issues.

Immediate issues include those that needto be addressed as soon as possible, and rep-resent the highest priority areas. But inchoosing where to invest in the short-term,it is also important to develop capacity toaddress medium and long-term priorities.This relationship between short-term and

longer-terms needs is particularly importantin fields that may take many years to produceuseable results, such as predictive toxicology.The medium to long-term research areashighlighted in Table 5 are those we shouldbegin addressing now, if a long-term sustain-able research program is to be developed.

Immediate research needs include investi-gations concerned with reducing risksencountered by people handling nanomateri-als and addressing risk posed by productsalready in commercial use, or close to com-mercialization.The top tier of research needsidentified in Table 5 address:

• Research methods—ensuring diverseresearch expertise is used to the full;

• Toxicity testing—screening new nanomaterials for potential toxicity;

• Measurement—charactering nanomaterials releases and exposure;

• Control—Preventing nanomaterials releaseand exposure; and;

• Best practices—developing ways of work-ing as safely as possible with engineered nanomaterials.

Investments in medium- and long-termresearch areas over the next two years shouldsupport a variety of endeavors, includingresearch addressing environmental impacts,developing a systematic approach to under-standing and managing risks from nanotech-nologies, and developing the capabilities tobetter predict risks posed by new nanomate-rials. By supporting this work now, we canbegin to build research capacity, and developthe knowledge base needed to anticipate howthe unique properties of emerging materialsand technologies might affect biological sys-tems in the future.

30


Category Research Needs• Appropriate measurement methods

• Responsive and effective methods of doing risk research

• Best practices for working with engineered nanomaterials• Engineering controls

• Personal protective equipment and respirator development and evaluation

• Process-based controls

• Exposure routes

• Sources of exposre

• Instrument-based exposure metrics

• Potential release routes

• Toxicity screening tests

• Control and management of spills• Dose-metrics relevant to target organs• Ecotoxicity - toxicity testing• Health outcomes associated with exposure• Life cycle analysis• Measurement standards• Nanomaterial characterization• Predictive toxicology - role of physicochemistry and mechanisms of toxicity

• Risk assessment• Routes of entry into the body• Safety (risk of physical harm)• Toxicity evaluation, including identification of appropriate endpoints and testing methods

• Computational toxicology• Control - substitute materials• Dispersion, transformation, fate, persistence and bioaccumulation in the environment• Ecotoxicity - toxic mechanisms• Informatics• Nanomaterials release into the environment• Standards - terminology, reference materials• Structure activity relationships• Transport, transformation and fate in the body

Imm

edia

te re

sear

ch n

eeds

Early

inve

stmen

t in

med

ium

-term

rese

arch

Early

inve

stmen

t in

long

-term

rese

arch

TABLE 5. SHORT-TERM RESEARCH NEEDS (NOMINALLY 2007–2009)

Research is categorized as addressing immediate needs, or laying the groundwork for medium-term and long-term priorities, based on Table 4. Research needs are listed in alphabetical order, and are not further prioritized.

Now that a short-term research agenda hasbeen identified, how do we ensure that it iscarried out in an efficient and timely manner?This will entail developing appropriate strate-gic action plans within the agencies andorganizations that provide funding. However,as was discussed earlier, these plans must betied to an overarching strategic research frame-work if they are to be effective. In these finalpages, I consider what a viable frameworkmight look like.

An effective framework for strategic nan-otechnology risk-based research will have anumber of attributes. It will provide a relevantlink between the implementation of nanotech-nologies and the research necessary to ensureappropriate oversight of risk. It will ensure thatresearch conducted within different agenciesand organizations is coordinated at the nation-al level. It will enable coordination and partner-ships between international initiatives. It willallow resources to be allocated appropriately toaddress critical issues. It will ensure researchcapacity is built up to address new risks.And itwill provide broad strategic research prioritiesfor assessing and managing potential risk. Asuccessful strategic risk research framework thatunderpins “safe” nanotechnologies will also beresponsive to the increasing sophistication ofthese technologies, and through regular reviewand revision will keep the priorities in linewith emerging issues.

Responsibility for a strategic research frameworkWho should be responsible for such an over-

arching framework? Some might suggest itshould be the industries that stand to gainfrom nanotechnology.37 It is certainly inindustry’s best interest to ensure that appro-priate risk research frameworks are put inplace, as a way to maintain public and com-mercial confidence in their products and min-imize the chances for adverse impacts.However, one would not expect them to con-duct more general and basic research into thebroad challenges posed by nanotechnology.Additionally, since industry also has an eco-nomic incentive to sell products, their researchis not always made public, and findings mightbe considered suspect by some groups, if notsupported by independent studies.

The most viable alternative to an industry-led strategic research framework is a govern-ment-led framework. A strategic researchframework developed and administered by thefederal government would combine societalaccountability with a high level overview ofresearch needs. Government science policyexperts also are experienced with developingresearch agendas that deal with broad, genericissues, and they are routinely involved in proj-ects that emphasize partnerships and inter-agency coordination. It is also fair to assert thatthe federal government has a social responsibil-ity for developing and implementing an effec-tive strategic research framework: The federalgovernment is investing a significant sum ofmoney into nanotechnology research anddevelopment—over $1 billion dollars in 2006.38

With this investment must come a certaindegree of social responsibility to ensure that

32

Implementing a strategic research framework

37. Sizing Nanotechnology’s Value Chain, Lux Research Inc., New York, NY, (2004) 38. The National Nanotechnology Initiative. Research and Development Leading To a Revolution in Technology and Industry.

Supplement to the President’s FY2006 budget, Nanoscale Science Engineering and Technology subcommittee of theNSTC,Washington DC, (2005)

any new risks associated with the applicationsit is helping usher into existence are assessedand managed appropriately. The governmenthas a responsibility to protect people who maybe directly or indirectly affected by new nan-otechnology materials, processes and products.It also has a responsibility to the business com-munity, to help it understand the social andtechnical risks associated with the technologiesthe government is encouraging it to support.

Components of a government-ledstrategic research frameworkA successful government-led strategic researchframework will need to address four areas:

Linking research to oversight. Ultimately, theaim of a strategic risk research frameworkwould be to minimize and manage riskthrough applying existing knowledge anddeveloping new knowledge. However, it willbe ineffective in the long-term if research isnot linked to oversight, whether this takes theform of regulation, voluntary programs, bestpractices or other risk management tools andapproaches.

Balancing different approaches to researchand research funding. Answers to short-term critical research questions require target-ed and applied research, while understandingmechanisms of risk and risk managementmust be underpinned by basic (and investiga-tor-driven) research.All types of research havetheir place. However, an effective strategicresearch framework will ensure that differentapproaches to funding and managing researchmatch the research needs.

Authority to direct and support research.An effective strategic research framework musthave teeth. It will not be sufficient merely tosuggest areas of research to respective agencies,

or to rely on agency resources to support thenecessary investigations.While research organ-izations require a certain level of autonomy, aneffective strategic research framework wouldinclude mechanisms that ensure that work isdone by the appropriate organizations, and thatresource levels are adequate to the task.

Coordination and partnership. As well asdirecting and coordinating research within thefederal government, a successful strategicresearch framework would include provisionsto coordinate and partner with industry, inter-national governments, and non-governmentorganizations.With such provisions, both pri-vate and public resources can be allocated tomaximize returns and minimize redundancy.

Development and execution of such astrategic framework within the federal gov-ernment will require oversight across agencies.The Nanotechnology Environmental andHealth Implications (NEHI) working groupof the Nanoscale Science, Engineering andTechnology subcommittee (NSET) is wellpositioned to address some aspects of a strate-gic research framework, but it is restricted inits ability to address issues related to oversight,or to direct research and resources.An existinggovernmental coordination group betweenThe Occupational Safety and HealthAdministration (OSHA), the Mine Safety andHealth Administration (MSHA), the NationalInstitute for Occupational Safety and Health(NIOSH) and the Environmental ProtectionAgency (EPA) (called the OMNE group)includes two of the key research agenciesaddressing nanotechnology, but again has onlylimited scope and authority. It is also doubtfulwhether the limited membership of OMNEmakes it suitable for overseeing a broad strate-gic research framework. In their current con-figurations, neither the NEHI or the OMNE


would appear to be adequate for developingand implementing the type of strategic riskresearch framework necessary for the develop-ment of sustainable nanotechnologies.

Unless significant changes are made to thescope and structure of NEHI, a new intera-gency group will be necessary to oversee anappropriate strategic framework. It shouldideally be established outside the structure ofNSET—which does not have a clear mandateto consider oversight issues—although itshould coordinate with NSET. The groupshould be comprised of representatives fromthe key regulatory and oversight-focusedresearch agencies, including NIOSH, EPA,OSHA, FDA, CPSC, USDA DOT andNIEHS. Representation from agencies suchas NIH, NSF, DOD, and DOE who are nowfunding basic or applied research that canoffer insight into risks (even if risk assessmentis not the primary objective) also should beconsidered, as long as a bias away from risk-specific research does not result.

The group must have authority to ensuresufficient funding and resources are availablethrough various mechanisms. Maintaining thecurrent situation where agencies such as EPAand NIOSH—entities with the primaryresponsibility to protect people and the envi-ronment from risks—receive little support fornanotechnology risk research is untenable, ifcritical questions are to be answered in atimely fashion.

What might a short-term strategicresearch plan look like?Having considered research that is needed insupport of “safe” nanotechnology—along withthe prioritization of this research in the short-term and a strategic framework within whichthis research can be carried out—two keyquestions remain: while the federal govern-ment would oversee the initiative, who would

do the actual work, and how much would itcost? Although these are complex questions toanswer, I have attempted to construct a pro-posed action plan that addresses short-termrisk research needs.This action plan is not somuch a set of recommendations as a perspec-tive to stimulate dialogue. It does, however,serve three tangible purposes: It provides anestimate of how much the research might cost,identifies lead agencies, and describes a divisionof labor between these agencies.

Targeted researchTargeted research is research aimed at address-ing a specific question or issue. It may be con-ducted inside an agency, or externallythrough grants and contracts. The commontheme is that it starts with a specific question,and applies resources as appropriate to obtaintimely and relevant answers.

In table 6, a plan to address the short-termresearch areas previously developed is present-ed. It incudes estimates of how much theresearch might cost, and who should lead inimplementing it. Three things are apparentfrom this table:

Cost. If significant progress is to be made, atleast $50 million a year over the next twoyears should be invested in targeted, highlyrelevant research into nanotechnology risks.This figure is five times more than currentgovernment spending in this area.

Lead Agencies. Targeted research is mostappropriately led by four agencies—EPA,NIH (mainly through the National Instituteof Environmental Health Sciences orNIEHS), NIOSH and NIST.

Collaboration. Some research needs can besuccessfully accomplished only through cross-agency collaboration. This includes the

34


TABLE 6. SHORT-TERM RESEARCH GOALS

Cross Agency

EPA

NIH

NIOSH

NIST

Total

• Develop research methodologies to proactively address risk• Begin developing appropriate risk assessment tools• Preliminary development of informatics systems for nanomaterials

• Identify sources and routes of exposure and release - environment• Develop and evaluate environmental measurement methods• Preliminary development of appropriate methods for evaluating ecotoxicity• Preliminary development of life cycle analysis tools for engineered nanomaterials• Preliminary investigation of ecotoxicity mechanisms• Preliminary investigation of nanomaterial release into the environment• Begin to study dispersion, transformation, fate, persistence and bioaccumulation

in the environment

• Begin to evaluate the toxicity of representative nanomaterials• Preliminary development of appropriate toxicity testing endpoints• Preliminary development of appropriate toxicity testing methods• Begin developing predictive toxicology capabilities

• Begin developing computational toxicology for engineered nanomaterials• Preliminary investigation of nanomaterial structure activity relationships

• Develop and evaluate human exposure measurement methods• Develop guidance on best possible working practices• Develop and evaluate personal protective equipment• Develop and evaluate respiratory protective equipment• Develop and evaluate process-based controls• Identify sources and routes of exposure and release - workplaces• Develop instrument-based exposure metrics• Develop and evaluate appropriate toxcity screening tests

• Develop a preliminary understanding of organ-specific dose• Preliminary research exploring associations between nanomaterials exposure and

human health outcomes• Begin to develop methods to control and manage spills• Study the role and significance of routes of entry into the body• Preliminary investigations of nano-specific safety issues

• Begin studying transport, transformation, and fate in the body• Preliminary evaluation of risk reduction through material substitution

• Preliminary development of appropriate nanomaterials characterization methods• Begin developing measurement and characterization standards

• Begin developing standards for terminology and reference materials

7

20

24

46

9

106

Lead Agency Short Term Research Goals Estimated Funding†

Proposed lead agencies and minimum targeted federal funding levels to address identified short-term researchgoals. Estimated funding is in $millions (USD) over a two-year period, and includes intramural and extramuralfunding of risk-specific research. Research goals addressing immediate, medium-term and long-term areas areshaded from dark to light (based on Table 5).†Estimated funding over 2 years.

development of research methodologies toproactively address risk.

Short-term research goals fall within fivegeneral areas:

Risk assessment. This includes researchmethodologies, risk assessment tools and infor-mation management.This area is so diverse andcrosses so many boundaries that cross-agencyleadership will most likely be needed.

Environmental impact. High priorityresearch goals include identifying routes ofrelease and exposure, and measurementmethods. This research falls within EPA’smandate and competency, and indeed theagency has already demonstrated leadershipin addressing the environmental impact ofnanotechnologies.

Human health impact. High priorityresearch goals include exposure measure-ment methods, controlling release of materi-al and preventing exposure, and developingtoxicity screening tests.These goals lie with-in the scope of NIOSH’s mission, and theagency has been active in developing arobust research portfolio addressing humanhealth impact.

Predicting hazard. The ability to predict thehazard of a new engineered nanomaterial,and even to reduce its toxicity through care-ful engineering, is a long-term goal thatneeds an initial research investment now.Thefoundational research needed into toxicity,including mechanisms of action, is mostappropriately led by NIH. A comprehensiveresearch program addressing the toxicity ofselect nanomaterials has been established bythe National Toxicity Program under theadministration of NIEHS, further supportingNIH leadership in this area.

Materials characterization. An ability tocharacterize nanomaterials appropriatelywhen evaluating potential risk will requireinvestment in basic research now. NIST isideally positioned to lead the development ofcharacterization methods and standards,building on extensive expertise and experi-ence in this area.

It is important to distinguish betweenagencies that should lead research, and thosethat are capable of doing the work.Agenciessuch as DOE, DOD and NSF are alreadysupporting fundamental research addressingthe potential impact of nanotechnology(table 1), and they will no doubt continue toprovide valuable support for this research.However, it must be asked whether these andsimilar agencies should be taking a leader-ship, as opposed to a supporting role, instrategic targeted risk-focused research,which may lead to nanotechnology oversightand regulation.

The Food and Drug Administration (FDA)clearly has a critical role to play in determin-ing the direction and relevancy of strategicrisk-based research, and yet it is not listed intable 6 as a key research agency. While FDAdoes have a limited research capacity in thisarea, current activities are predominantlycoordinated through the National ToxicologyProgram (NTP) and NIEHS. Although thismay change in the future, the agency is bestpositioned to advise on strategic researchdirections, while continuing to participate inactive research through the NTP.

Indirect researchAs has already been noted, research into basicnanoscience and nanotechnology applica-tions has the potential to inform an under-standing of the impact of nanotechnologies.Examples include the development of char-

36

acterization methods that enable theadvancement of nanotechnology as well asrisk evaluation, and the transfer of knowledgefrom the development of medical therapeu-tics to an understanding of toxicity. Relevantresearch will most likely be led by pure andapplied research agencies such as NSF andNIH, along with DOD, DOE, USDA andNIST. A strategic research plan must findways to tap into this kind of work to provideanswers to risk-related questions.

Placing a value on how much indirectresearch is needed is a near-impossible task. Itis clear that a comprehensive understandingof risk will not be developed as quickly oreffectively if this source of information isoverlooked. And yet, it is dangerous to assessthe value of indirect research solely on itspotential to inform an understanding of risk.Returning to the example given above:Research into new characterization methodsmight lead to technologies that can be used tomeasure nanomaterial exposure. But unlessthis latent potential has been realized throughtargeted research, the work will be worthlessto understanding and addressing risk.

PartnershipsAn effective strategic research plan will lever-age resources through collaboration and part-nerships. For the federal government, thiswould include working with industry andinternational partners, as discussed above.Thisis an area where there already has been con-siderable activity within the federal govern-ment: The NNI has been working closely

with industry through the ConsultativeBoards on Advancing Nanotechnology(CBAN),39 and was responsible for initiatingthe International Dialogue on ResponsibleNanotechnology in 2004. In addition,NIOSH is developing partnerships with nan-otechnology industries to evaluate methods ofassessing and controlling risk,40 EPA is partner-ing with three other agencies to support risk-focused research, and the agency is also devel-oping a voluntary program for industry toprovide and develop risk-related informationon new materials.41

Within the broad and diverse range ofpartnership opportunities in this area, threespecific aspects should be included within ashort-term strategic research plan:

Transparency and information sharing.Mechanisms should be put in place wherebyindustry and government can openly shareinternal information relevant to understand-ing and addressing risk. Where this can beachieved without compromising sensitivebusiness information, it will facilitate therapid development of robust standards of careacross nanotechnology industries, as well asensuring that researchers and policymakershave access to the best possible informationon risk assessment and management.Willingness to share information also willsupport public trust in nanotechnology.

Coordinated strategic research plans.Effective mechanisms are needed to ensurecoordination between international research


39. Chemical Industry Vision 2020 technology Partnership & SRC, Joint NNI-ChI CBAN and SRC CWG5Nanotechnology research needs recommendations, (2005)

40. National Institute for Occupational Safety and Health. NIOSH to Form Field Research Team for Partnerships inStudying,Assessing Nanotechnology Processes. www.cdc.gov/niosh/topics/ nanotech/newsarchive.html#fieldteam.Accessed June 2006.

41. Overview Document on Nanoscale Materials, 11/22/05, National Pollution Prevention and Toxics AdvisoryCommittee (NPPTAC).A federal advisory committee to the U.S. Environmental Protection Agency,Washington DC, (2005)

efforts, and between industry and govern-ment strategic research plans. In the UnitedStates, CBANs have been partially successfulat developing a constructive dialoguebetween industry and government.42

However, these boards have had limited suc-cess so far in coordinating actual researchprojects, as opposed to advising on researchneeds. In the broader research community,channels of communication certainly existbetween countries. The challenge is to takethese relationships to the next level andimplement coordinated strategic researchplans so that work is complementary, notduplicative, and all necessary avenues ofinvestigation are pursued.Two possible mod-els for such international collaboration arethe sequencing and mapping of the humangenome and Arabidopsis genome.

Joint government-industry funding ofresearch. A powerful and proven approachto leverage government and industry research

funding is to establish a research institutejointly funded by government and industry.Amodel example is the Health Effects Institute(HEI)43 which was established to address thehealth impact of air pollution. This public-private effort has been tremendously success-ful since its inception in supporting highquality independent and authoritativeresearch.44 A number of people have suggest-ed, informally, establishing a similar institutefor addressing the health and environmentalimpact of engineered nanomaterials. Such anendeavor would extend the range of researchundertaken, ensure research is closely tied tocommercial products, and support capacitybuilding within the research community.Whether it would involve working throughthe existing HEI, or establishing a newNanotechnology Effects Institute (NEI), thistype of partnership would make maximumuse of government and industry resourcesand expertise to support targeted independ-ent research.

38

42. Chemical Industry Vision 2020 Technology Partnership & SRC, Joint NNI-ChI CBAN and SRC CWG5Nanotechnology Research Needs Recommendations, (2005)

43.The Health Effects Institute is a nonprofit corporation chartered in 1980 as an independent research organiza-tion to provide high-quality, impartial, and relevant science on the health effects of air pollution.Typically, HEIreceives half of its core funds from the U.S. Environmental Protection Agency and half from the worldwidemotor vehicle industry. Further details can be found at www.healtheffects.org

44. Health Effects Institute, Boston MA, (2005)

Nanotechnology is a reality now, and ourability to produce ever-more sophisticatedmaterials, processes and products by engi-neering at the nanoscale will only increaseover the coming years.Yet our understand-ing of the potential health, safety and envi-ronmental impacts of these emerging tech-nologies is rudimentary at best. Currentrisk-based research is poorly directed andfunded, and is unlikely to provide answerswhere they are most needed. And neededthey are, since a proper understanding ofrisks is the only way to assure the emer-gence of economically viable technologiesthat do not harm people, animals, or theenvironment.

In this paper, I have presented a strategyfor risk research that encompasses what needsto be done in the short term, who needs to

do it and how much it will cost, if we are tounderstand and address risks in a systematicmanner. Some of this research is alreadybeing supported by the federal government.But without the context of a strategicresearch framework, it is difficult to judgewhere it is making a significant contribution.

No doubt some of these ideas will beembraced, while others will be dismissedout of hand.Yet when all is said and done,the truth remains that without a viablestrategic research framework, we will not beable to provide the answers that businesses,workers and the public deserve and, increas-ingly, demand. My hope is that this paperwill stimulate a dialogue that leads to muchgreater emphasis on risk research through astrategic, coordinated and above all, relevant,framework for action.


Summary

1. Changes need to be made in riskresearch responsibility within the federalgovernment. There should be top-downauthoritative oversight of strategic risk-based research within the federal govern-ment, and nanotechnology risk researchneeds to shift to federal agencies with aclear mandate for oversight and forresearch into environment, health andsafety issues.

2. Adequate funding must be provided forhighly relevant risk research. Key leadagencies, including the EnvironmentalProtection Agency, the National Institutefor Occupational Safety and Health, theNational Institutes of Health and theNational Institute of Standards andTechnology, will require an estimated min-imum budget of $100 million over thenext two years devoted to highly relevant,targeted risk-based research if criticalknowledge is to be developed. In addi-tion, there should be a complementaryand identifiable investment in basicresearch and applications-focused researchthat has the potential to inform ourunderstanding of risk. Mechanisms shouldbe developed to make full use of this indi-rect but complementary research.

3. A short-term strategic risk-research planshould be developed and implemented.The research plan should address issuescritical to ensuring the safety of nan-otechnologies in or close to commercialuse.Top priorities should include identi-fying and measuring nanomaterialsexposure and environmental release,evaluating nanomaterials’ toxicity, con-

trolling the release of and exposure toengineered nanomaterials, and develop-ing “best practices” for working safelywith nanomaterials. Strategic researchinvestment in longer-term issues such aspredictive toxicology should also beundertaken now, to build research capac-ity and provide the scientific basis foraddressing new risks.

4. Mechanisms should be developed forjoint government-industry risk researchfunding. A research institute should beestablished along the lines of the HealthEffects Institute, enabling governmentand industry funding to be leveraged inthe service of strategic nanotechnologyrisk research.

5. Nanotechnology risk research must becoordinated internationally. Mechanismsshould be established to achieve effectiveglobal coordination of government-fund-ed research into the environmental, safetyand health implications of nanotechnolo-gy.There should be mechanisms facilitat-ing the free exchange of information onresearch needs, activities, and priorities.There also should be mechanisms forsharing costs and resources, which can bepursued in the context of coordinatingstrategic research agendas and by jointlyfunding specific projects. In addition,there is a need for international coordina-tion of research conducted by non-gov-ernmental groups. Finally, the need for aglobal focus on nanotechnology riskscould justify establishing an independentsecretariat, funded by member countries,to oversee international risk research.

40

Recommendations

6. An interagency oversight group shouldbe established with authority to set,implement and review a strategic riskresearch framework. The group wouldbe responsible for developing a top-levelstrategic framework that would serve as aguide for the coordination and conduct ofrisk-related research in relevant agencies.It would have the authority to set andimplement a strategic research agenda andassure agencies are provided with appro-priate resources to carry out the work.The group would direct efforts to providea strong scientific basis for regulatorydecisions, thus bridging the existing gapbetween the need for oversight and ourpoor technical understanding of nan-otechnology risks. It would also ensurethat the results of risk-relevant research areput to practical uses, including educationand outreach programs. In addition, thegroup would ensure risk-related researchis coordinated between industry and gov-ernment, and between the U.S., othercountries and international organizations.

7. A rolling, independent assessment oflong-term research needs and strategiesshould be established. An independentstudy effort is needed to identify futureresearch needs, provide advice on how toincorporate them into a strategic researchframework, and evaluate progress towardachieving strategic research goals. Thestudy would be carried out by an author-itative organization such as the NationalAcademies. It would ideally run for fiveyears, with an option that would allow itto be extended for an additional fiveyears.The first set of strategic recommen-dations should be released within twoyears of the study’s inception. The scopeof the study would include methods ofstimulating and managing risk-focusedresearch that are responsive to rapidlydeveloping and complex technologies,and developing effective collaborationbetween industry, academia, internationalgovernments and other stakeholders.


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

PRIVATE CITIZEN MEMBERS

Carol Cartwright, Robin Cook, Donald E. Garcia, Bruce S. Gelb, Charles L. Glazer, TamiLongaberger, Ignacio E. Sanchez

The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in 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.

THE PEW CHARITABLE TRUSTS serves the public interest by providing information, advancingpolicy solutions and supporting civic life. Based in Philadelphia, with an office inWashington, D.C., the Trusts will invest $204 million in fiscal year 2006 to provide organi-zations and citizens with fact-based research and practical solutions for challenging issues.

The WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS is the living, national memo-rial to President Wilson established by Congress in 1968 and headquartered inWashington, D.C. The Center establishes and maintains a neutral forum for free, open andinformed dialogue. It is a nonpartisan institution, supported by public and private funds andengaged in the study of national and international affairs.

CONTENTSAcknowledgements

ForewardExecutive Summary

Setting the SceneA Reason for Caution

Rethinking exposure and toxicityNew risks require new research

Why nanotech boosters should fear a dearth of risk researchNanoechnology Research and Develpment in the U.S..

A short history of the National Nanotechnology InitiativeEnvironmental, safety and health research

within the National Nanotechnology InitiativeCurrent federal government investment in ES&H research

Connecting research activities with research needsDeveloping a Strategic nanotechnology Risk Research Framwork

An immediate short-term research strategy is neededIdentifying and prioritizing research needs

Nanotech environment, safety and health research needsPrioritizing research

Overarching objectives for prioritizationPrioritizing research - a ten-year perspective

Short-term research prioritiesImplementing a strategic research frameworkResponsibility for a strategic research framework

Components of a government-led strategic research frameworkWhat might a short-term strategic research plan look like?

SummaryRecommendations

135710101213151517

18212323242427272830323233343940

Project on EmergingNanotechnologies

Project on Emerging Nanotechnologies is supported by THE PEW CHARITABLE TRUSTS

Andrew D. Maynard

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

T 202.691.4000F 202.691.4001www.wilsoncenter.org/nanowww.nanotechproject.org

Project on Emerging Nanotechnologies

NANOTECHNOLOGY:A Research Strategy

for Addressing Risk

PEN 3JULY 2006

NANOTECHNOLOGY - · PDF filein nanotechnology research,2 not very much is being spent on ......

Documents

Transcript of NANOTECHNOLOGY - · PDF filein nanotechnology research,2 not very much is being spent on ......