Project on EmergingNanotechnologies

Project on Emerging Nanotechnologies is supportedby THE PEW CHARITABLE TRUSTS

J. Clarence DaviesOne 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 EmergingNanotechnologies

PEN 13JULY 2008

AN AGENDA FOR THE NEW ADMINISTRATIONNANOTECHNOLOGY OVERSIGHT:

confidential business information

Comprehensive EnvironmentalResponse, Compensation,and Liability Act

Chronic Hazard Advisory Panel(under the Consumer ProductSafety Act)

Consumer Product Safety Commission

Dietary Supplement Healthand Education Act

environment, health and safety

Environmental Protection Agency

Food and Drug Administration

Federal Food, Drug, andCosmetic Act

Federal Insecticide, Rodenticide,and Fungicide Act

fiscal year

Interagency NanotechnologyRegulatory Group (proposed)

material safety data sheet(OSHA requirement)

non-governmental organization

National Institute of OccupationalSafety and Health

National Nanotechnology Initiative

National Science Foundation

Organization for EconomicCooperation and Development

Office of Management and Budget

Office of Research and Development(part of EPA)

Occupational Safetyand Health Administration

Office of Technology Assessment

Project on EmergingNanotechnologies, WoodrowWilson International Centerfor Scholars

Resource Conservationand Recovery Act

significant new use rule (under TSCA)

Toxics Release Inventory

Toxic Substances Control Act

CBICERCLA

CHAP

CPSCDSHEA

EHSEPAFDA

FFDCA

FIFRA

FYINREG

MSDS

NGONIOSH

NNINSF

OECD

OMBORD

OSHA

OTAPEN

RCRA

SNURTRI

TSCA

ACRONYMS

NANOTECHNOLOGY OVERSIGHT:A N A G E N D A F O R T H E N E W A D M I N I S T R A T I O N

EXECUTIVE SUMMARY iv

I. ACTION IS NECESSARY 1

II. WHAT NEEDS TO BE DONE 7

III. THE LONGER TERM 21

APPENDIXESA. Bibliography 25

B. NNI Budget 26

C. Proposed Legislative Changes to TSCA 28

by J. Clarence Davies

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

The author thanks Lisa Barclay, Linda Breggin, Marla Felcher, Mike Newman, and Mike Taylorfor their generous donation of time in reading the manuscript and responding to questions. Healso thanks the Project on Emerging Nanotechnologies—Dave Rejeski, Andrew Maynard,Colin Finan, Alex Parlini, and especially Julia Moore—for their support and unstinting helpful-ness. The Pew Charitable Trust provided the funding to make all this possible, and Resourcesfor the Future provided support to the author to help him explore the frontiers of technology.As usual, the author takes full responsibility for the contents of this report.

ACKNOWLEDGEMENTS

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The next presidential administration will face ahost of complex policy issues concerning energy,the environment, food safety, consumer prod-ucts and the workplace. One issue, however,that will impact virtually all of these policy areasis nanotechnology oversight.

Nanotechnology, the science and technolo-gy of manufacturing and manipulating mate-rials at the tiniest of scales, creates endlessopportunities to address the many significantsocial and economic challenges facingAmericans. But some new nanoscale materialsmay present unconventional risks to con-sumers, workers, and the environment.Therefore, without robust oversight mecha-nisms to underpin safe use, the full benefits ofnanotechnology may never be realized.

Today, more than 600 manufacturer-identi-fied consumer products are available on themarket using nanotechnology. In addition,there are countless other commercial and indus-trial applications of which the public and poli-cymakers are not even aware. Unfortunately,federal agencies currently have to draw ondecades-old laws—many of which are woefullyout of date—to ensure the safe developmentand use of these technologically advanced prod-ucts. Federal officials need 21st century tools forcutting-edge technologies. Anything short ofthat is unacceptable and may leave the publicunprotected from emerging risks.

Given the rate of development and commer-cialization of nanotechnologies, time is of theessence. In order to ensure the safe developmentof this rapidly advancing technology, which isprojected will enable 15 percent of globallymanufactured goods worth $2.6 trillion by2014, there needs to be an increase in fundingfor nanotechnology risk research in the fiscal

year 2009 budget to $100 million and in FY2010 to $150 million. And through earlyadministrative action, the next president shouldquickly implement new oversight mechanismsfor nanotechnology. Such actions include col-lecting safety information on uses of nanomate-rials in food production and packaging; updat-ing federal occupational safety laws; and defin-ing nanomaterials as “new” substances underfederal laws, thereby allowing agencies such asthe Environmental Protection Agency and theFood and Drug Administration to obtain moreinformation on nanomaterials.

The author of this report, J. Clarence Davies,has invested significant thought into nanotech-nology oversight issues in recent years. In thispaper, he points to ways existing laws can beapplied or changed, if necessary, to provideneeded oversight of nanoscale materials. He alsocalls for an increase in resources to research therisks posed by these materials and outlines aplan for future study and oversight.

The goal of this report is to highlight theimportance of creating sensible nanotechnologyoversight policies and describe the actions thatneed to be taken by the next president. Manyof the potential risks of nanoscale materials havealready been identified, and for the world torealize the benefits of this technology the nextadministration must act swiftly and carefully.This will be a challenge, but one that could havelimitless opportunities to improve the world inthe 21st century. This report provides a blue-print for early action by the next White Houseand key regulatory agencies.

David RejeskiDirector

Project on Emerging Nanotechnologies

FOREWORD

Dr. Davies, a senior advisor to the Project onEmerging Nanotechnologies and a senior fellowat Resources for the Future, is one of the fore-most authorities on environmental research andpolicy. He helped pioneer the related fields ofrisk assessment, risk management, and riskcommunication, and his work has advanced ourunderstanding of cross-media pollution, thetendency of pollutants to move across bound-aries, from air to water to land, revealing short-comings in the legal and regulatory framework.

Davies served during the first BushAdministration as Assistant Administrator forPolicy, Planning and Evaluation at the U.S.Environmental Protection Agency (EPA).Earlier, he was the first examiner for environ-mental programs at the Bureau of the Budget(now the Office of Management and Budget).In 1970, as a consultant to the President’sAdvisory Council on Executive Organization,he co-authored the plan that created EPA. Dr.Davies also was Executive Vice President of TheConservation Foundation, a non-profit thinktank on environmental policy; ExecutiveDirector of the National Commission on theEnvironment; and a senior staff member at the

Council on Environmental Quality, whereamong other activities, he wrote the original ver-sion of what became the Toxic SubstancesControl Act. He has served on a number ofcommittees of the National Research Council,chaired the Council’s Committee on DecisionMaking for Regulating Chemicals in theEnvironment, chaired the EPA Administrator’sAdvisory Committee on Toxic Substances, andserved on EPA’s Science Advisory Board. In2000, he was elected a Fellow of the AmericanAssociation for the Advancement of Science(AAAS) for his contributions to the use of sci-ence and analysis in environmental policy.

Davies is the author of The Politics ofPollution, Neighborhood Groups and UrbanRenewal, Pollution Control in the United States,and several other books and monographsaddressing environmental policy issues. A polit-ical scientist by training, Davies received hisB.A. in American government from DartmouthCollege, and his Ph.D. in American governmentfrom Columbia University. He taught atPrinceton University and Bowdoin College, andhas helped mentor a generation of environmen-tal policy researchers.

ABOUT THE AUTHOR J. CLARENCE (TERRY) DAVIES

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Few domestic policy areas that the newadministration must address will have greaterlong-range consequences than nanotechnolo-gy—a new technology that has been com-pared with the industrial revolution in termsof its impact on society. If the right decisionsare made, nanotechnology will bring vastimprovements to almost every area of dailyliving. If the wrong decisions are made, theAmerican economy, human health and theenvironment will suffer.

Nanotechnology can have a major impacton many of the most important problems fac-ing the United States. It can reduce depend-ence on foreign oil, help deal with global cli-mate change, improve the country’s healthsystem, strengthen national defense, helpfight terrorism and make a major contribu-tion to the national economy. Nano-technology is also important as a prototype ofthe technological opportunities and chal-lenges that will characterize the 21st century.The country needs to learn how to deal withpotential adverse consequences of new tech-nologies and how to make sure the technolo-gies best serve society’s needs.

The existing laws and institutions for deal-ing with nano and other technologies are weakand inadequate. The oversight system needs tobe repaired. The regulatory agencies lackresources, some to the point of being non-functional. The laws have huge gaps and,more often than not, fail to protect the public.Nanotechnology highlights these inadequaciesand provides an opportunity to act on them.

This report is a blueprint for what shouldbe done about nanotechnology in the first fewmonths of the new administration. It containsmore than 35 recommendations. The follow-ing actions are necessary:

• Maximize the use of existing laws:Although the laws for nanotechnology over-sight need to be changed, much can be donewithin existing authorities. Nanomaterialsshould be defined as “new” substances underthe Toxic Substances Control Act (TSCA)and the cosmetics, food additive and foodpackaging provisions of the Federal Food,Drug, and Cosmetic Act (FFDCA), therebyenabling the Environmental ProtectionAgency and the Food and DrugAdministration to consider the novel quali-ties and effects of nanomaterials. The feder-al pesticide law should be enforced for nanoanti-microbial products such as clothing andhousehold appliances that use nanosilver.Existing regulations of the OccupationalSafety and Health Administration should beused to protect workers from nanoparticlesin the workplace.

• Increase research on the risks posed bynanomaterials: Federal spending to under-stand the potential risks posed by nanomate-rials is inadequate. Results of the limitedtesting that has been done provide reason forconcern: carbon nanotubes can irritate lungsin a way similar to asbestos; some nanoma-terials, when tested on rats, pass from nerveendings in the nose to the brain, bypassingthe blood-brain barrier; and some nanoma-terials can interact with DNA. These sub-stances could have widespread negativeimpacts—not only on the environment andhuman health but on consumer confidenceas well. Risk research is essential.

• Enact changes to existing oversight laws:Laws such as TSCA and FFDCA, whichcover adverse effects of nanomaterials,

EXECUTIVE SUMMARY

urgently need to be strengthened. For exam-ple, under the FFDCA, two major high-exposure applications of nanotechnology,cosmetics and dietary supplements, areessentially unregulated. In fact, the currentlanguage in the law serves primarily to assurethat there will not be adequate oversight.Other laws important for nano oversight,such as the Consumer Product Safety Act,also need radical revision.

• Plan for the future: Almost all the planningand debate about nanotechnology hasfocused on first-generation nanotechnology.The second generation of the technology isnow moving from science fiction to techno-logical fact, but society has not thought abouthow to deal with it or the other new tech-nologies that are sure to follow. A commission

should be named to consider oversightoptions for the 21st century. In addition, thegovernment’s ability to forecast technologicaldevelopments needs to be greatly improved sothat government and society are better pre-pared to manage what lies ahead.

Nanotechnology is likely to significantlychange the way we live. The new administra-tion has the opportunity to shape thesechanges and to ensure that the benefits of nan-otechnology are maximized and the risks areidentified and controlled. This is a vitallyimportant opportunity, and this reportdescribes how to act on it. The future of thetechnology is in the hands of the incomingadministration. The shape of the future willdepend significantly on what the new govern-ment does.

vi

The report’s recommendations are summarized on pages viii-ix.

SHORT-TERM AGENDA

viii

* Increase nanotech environment, health and safety research (EHS) funding

* Strengthen National Nanotechnology Initiative (NNI) coordination

* Require a peer-reviewed EHS research plan

* Encourage separation of NNI promotional and oversight functions

* Establish a Nanotechnology Effects Institute, similar to the Health Effects Institute (a jointundertaking of EPA and the automobile industry devoted to research on the healtheffects of the automobile)

Risk Research

* Establish an Interagency Nanotechnology Regulatory Group

* Develop a nanotechnology plan within each major regulatory agency (e.g. EPA, FDA)

* Improve intergovernmental coordination

Regulatory Coordination

* Increase regulatory agency budgets and staffing

Resource Requirements

Federal Agency Executive Actions

ENVIRONMENTAL PROTECTION AGENCY

* Define nanomaterials as “new” chemicals under the Toxic Substances Control Act (TSCA)

* Promote “green” nanotechnology

* Promulgate a TSCA information collection rule

* Expand regulation of anti-microbials under the federal pesticide law

* Evaluate the application of other EPA statutes to nanotechnology

FOOD AND DRUG ADMINISTRATION

* Collect information on safety testing, forthcoming products and potential adverse effects

* Establish criteria for determining which nanomaterials are “new” for regulatory purposes

* Regulate cosmetics and dietary supplements

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATIONAND NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

* Use existing OSHA regulations to deal with nanoparticles

NANOTECHNOLOGY OVERSIGHT

LONGER TERM AGENDA

ix

* Communicate to workers and firms about nanotechnology’s potential health effects andmeasures for controlling exposure

* Issue OSHA standards for nanomaterials

CONSUMER PRODUCT SAFETY COMMISSION

* Hire new staff to study nanotechnology exposure

* Create a Chronic Hazard Advisory Panel (CHAP) for nanotechnology products with significant exposure

Voluntary Efforts

* Use the DuPont–Environmental Defense framework as a basis for analyzing nanotechnology risks

* Issue a nanotechnology handbook for small businesses

Public Involvement

* Give the public more information about nanotechnology

* Convene a stakeholder dialogue

* Obtain the public’s views about nanotechnology

New Legislation

* Change TSCA to improve its effectiveness

* Amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to adequately regulate cosmetics

* Give FDA regulatory authority over dietary supplements

* Enact other changes to the FFDCA to give FDA authority to review safety tests on food and cosmetics

* Amend the NNI act to require an EHS research plan and to provide strengthened coordination powers

New Technologies, New Oversight

* Improve the government’s forecasting ability

* Create a commission to study oversight of new technologies

* Create new forms of oversight

* Indicates a priority recommendation

Nanotechnology is changing the world. Itpromises to transform every aspect of our lives.The actions of the incoming administration willbe critical in determining whether we can reapthe huge potential benefits of nanotechnologyand, at the same time, prevent its potentiallyserious dangers.

Nanotechnology has major economic andpolitical implications. Globally, nanotechnologyis expected to account for 11 percent of manu-facturing jobs by 2014 (Lux Research 2006, vol.1, p.19). Nanotechnology can help the govern-ment deal with many of the major problems itfaces—energy, climate change, water supply andhomeland security. Military applications of nan-otechnology could change the balance of poweramong nations. A widespread adverse eventfrom nanotechnology manufacturing or a nano-material could confront government agencieswith a crisis and bring development of the tech-nology to a halt.

Nanotechnology can result in clothes andwindows that never need washing; ways of pro-ducing clean water, generating power and pro-viding transportation that use half the energythat current methods do and at half the cost;computers with unimaginably large processingpower and memory; and remedies for many ofthe world’s illnesses. However, nanotechnologymay also produce materials that could have thesame effect on lungs as asbestos, damage humanDNA or wipe out bacteria necessary for thefunctioning of ecosystems. Decisions made inthe next few years will greatly influence whichaspects of nanotechnology become a reality.

SCOPE OF NANOTECHNOLOGY

Nanotechnology is the manipulation of mat-ter at the scale of individual atoms and mole-

cules. It includes processes for making materi-als, systems and structures, as well as the mate-rials and structures themselves. Some types ofnanomaterials exist in nature, but nanotech-nology, the deliberate engineering of nanos-tructures and materials, largely began in the1980s with the invention of new, more pow-erful types of microscopes.

Nanomaterials are usually defined as mate-rials that have at least one dimension smallerthan 100 nanometers. A nanometer is approx-imately 1/80,000th the width of a human hairor 1/7,000th the size of a single red blood cell.Materials at the nanoscale often exhibit phys-ical, chemical and biological properties thatare very different from those of their normal-sized counterparts.

Nanotechnology applications can be char-acterized as passive or active (IRGC 2007).The distinction is important because it high-lights the magnitude of the technologicalbreakthroughs still to come with nanotechnol-ogy. Passive applications are those in which thenanomaterial or structure does not changeform or function. Almost all the discussionsabout regulating nanotechnology to date havefocused on passive applications. Passive nanos-tructures are materials that are typically addedto existing products and materials. Most of theitems in the database of nanotechnology prod-ucts maintained by the Project on EmergingNanotechnologies (PEN) at the WoodrowWilson International Center for Scholars areexamples of passive nanotechnology applica-tions. The database contained more than 600manufacturer-identified nanotechnology con-sumer products as of February 2008. Theyincluded numerous cosmetics, a number of sil-ver-based anti-microbial products (including

1Nanotechnology Oversight:An Agenda for the New Administration

I. ACTION IS NECESSARY

food containers and no-smell socks) and otherproducts ranging from tennis racquets to teas.The number of products in the inventory hasdoubled within the past 14 months (see Figure1 ). Non-consumer nanotechnology productsnow on the market include electronic devices,catalysts, batteries and car bodies.

Nanostructures or nanomaterials aredefined as active when they are able to changetheir form or function. A simple example is ananti-cancer drug in which a dendrimer (a typeof nanomaterial) is designed to find cancercells, attach itself to the cells and then releasea chemical that kills them. On a more com-plex level, the increasing overlap betweenbiotechnology and nanotechnology will even-tually lead to nanosystems being used toassemble large systems that might includereplacement limbs for humans or complexrobots. The meaning of oversight in the con-text of active nanostructures is a challengeexperts are just beginning to face. This reportfocuses primarily on passive nanotechnology;the question of oversight for the future isaddressed in the final section.

NEED TO ACT NOW

Nanotechnology is developing rapidly. TheU.S. federal government budget for nanotech-nology for fiscal year (FY) 2009 totals $1.5billion (see Appendix B)—a 229 percentincrease since 2001. Several new products areadded to PEN’s inventory each week, and therate of introduction of non-consumer nan-otechnology products (such as drugs, catalystsand sensors) is probably equally high. As of2007, the Food and Drug Administration(FDA) had approved 24 nano-based drugs,and an additional 26 nanodrugs were under-going clinical trials (Zhang, et al. 2007).China, Japan, Korea and several Europeannations are competing with the United Statesfor the lead in developing the technology, andRussia recently announced a $5 billion nan-otechnology research and development pro-gram (Elder 2007). Twenty years from now,most of the products we use are likely to havesome nanotechnology component.

The results of tests performed to determinethe adverse effects of current nanomaterialsprovide reason for concern: carbon nanotubes

2

00

100100

200200

300300

400400

500500

600600

700700

800800FIGURE 1. TOTAL PRODUCTS LISTED

700

600

500

400

300

200

100

0

Num

ber

of P

rodu

cts

Mar 8, 2006 Apr 22, 2006 Sep 29, 2006 Nov 26, 2006 May 16, 2007 Oct 2, 2007 Feb 22, 2007

212 230

321356

475

580606

Source: www.nanotechproject.org/consumer

behave in unusual, and possibly harmful, waysin animal lungs, and there are suggestions thatsome nanotubes could be as harmful asasbestos if inhaled; studies in rats have shownthat some nanomaterials, when inhaled, passfrom the nerve endings in the nose to thebrain, bypassing the blood-brain barrier; andthere is emerging evidence that certain nano-materials can interfere with proteins andDNA in the human body, acting like a wrenchin the works of the building blocks of life.Because of their large surface-to-mass ratio,nanoparticles are more reactive than ordinarymaterials. They can also be far more explosivethan ordinary-sized materials—a propertythat the military is actively exploiting. In2007, the Russians exploded the first bomballegedly based on nanotechnology. It wasreportedly the largest non-nuclear bomb evertested (Elder 2007).

Nanomaterials have been used experimen-tally to improve the environment by cleaningup waste sites, purifying water and filteringair. Many applications of nanomaterialsreplace toxic substances or substitute for moreenergy-intensive processes (Schmidt 2007).Both the good and bad environmental effectsof nanomaterials are largely unknown. Onthe negative side, nanomaterials will beextremely difficult or impossible to removefrom the environment. Nanosilver is an exam-ple of the Jekyll-and-Hyde character of nano-materials (see Luoma forthcoming). The anti-microbial properties of nanosilver are beingused in a variety of products, but those sameproperties may pose a threat to the environ-ment as well as to waste-treatment plants thatclean sewage through bacterial action.

The combination of poorly understoodrisks and increasing commercial product flowled the World Economic Forum to declare the

risks of nanotechnology as one of the twomajor technological risks facing the planet.(The second risk is an attack on or a systemfailure of the global information infrastruc-ture.) (World Economic Forum 2008, p. 51).Similarly, the insurance firm Lloyd’s has iden-tified nanotechnology as a major “emergingrisk” (Lloyd’s 2007). A Lloyd’s report notesthat “nano-sized objects tend to be more toxicthan their large scale form” (p. 3); there is a“lack of regulation;” “the ‘wait and see’approach is increasingly becoming a danger-ous way to determine the risks;” and “[i]n thepast a vacuum of regulation has provedunhelpful to insurers” (p. 4). One reason fornervousness on the part of insurers andinvestors is the fear that some companies arenot being transparent. Recently, the InvestorEnvironmental Health Network, in collabora-tion with investment managers, who havemore than $41 billion in combined assets,released a report raising concerns that compa-nies are not apprising investors of potentialnanotechnology risks. The report notes that“companies dealing with nanomaterials … arenot disclosing the evidence of health risks ofnanotechnology products, nor the lack of ade-quate product testing prior to their sales”(Lewis, et al. 2008).

The U.S. government needs to act now toprotect the public and the environment fromthe potential adverse effects of nanotechnolo-gy. Many products are already on the market,and many more will follow. People are beingexposed to nanomaterials every day. We knowthere are potential dangers. There is little orno effective oversight. Doing nothing is a dan-gerous option.

Oversight also needs to be strengthened toensure that the benefits of nanotechnology arerealized. Over the past 50 years, we have had

3Nanotechnology Oversight:An Agenda for the New Administration

vivid examples of how adverse public opinioncan block or slow the development and applica-tion of new technologies; examples includenuclear power, genetically modified crops andstem cell research. Nanotechnology could meetthe same fate (Mandel 2005). The public’s reac-tions to new technologies are determined by avariety of factors, many of them not in therealms of science or rationality; however, thereis evidence that the perceived adequacy of over-sight of the technology is an important consid-eration in shaping people’s views (Macoubrie2005). Recent surveys have indicated decliningtrust in both government and industry to man-age the risks of emerging technologies (Hart2007). Although there is little public supportfor a moratorium on nanotechnology researchand development (which some non-govern-ment organizations have called for), there islikewise little support for industry self-regula-tion. One highly publicized adverse effect couldthreaten all the applications and social benefitsof nanotechnology.

Many knowledgeable people think that it ispremature to establish strong oversight of nan-otechnology because we do not yet knowenough about its possible adverse effects.Certainly we have much to learn. We do notknow enough about what effects may occuroutside the laboratory, we do not understandwhich characteristics of nanomaterials deter-mine the toxicity of the material and we donot understand how most nanomaterials trav-el in the environment. Many companiesinvolved with nanotechnology are aware ofthe potential risks but lack both the guidanceand scientific know-how to address them. Thelack of a clear road map is especially problem-atic for the small, innovative firms that makeup much of the nanotechnology landscape(Lindberg and Quinn 2007).

Despite the large gaps in knowledge,enough is known to begin testing nanomate-rials for safety. The International LifeSciences Institute has suggested a testingregime for nanomaterials, DuPont andEnvironmental Defense have produced adetailed framework for analyzing the possibleeffects of nanotechnology products and theOrganization for Economic Cooperation andDevelopment (OECD) is committed to test-ing several generic types of nanomaterials.Regulatory requirements are needed to amassenough test data to determine the technolo-gy’s effects. To move the science of nanotoxi-cology forward, it is necessary to have toxici-ty data on a large number of nanomaterialsand products. These data will not be generat-ed or made known if companies are notrequired to do so.

Without an adequate oversight system wecannot protect the public when adverse effectsare identified. A lack of action invites signifi-cant damage to people or the environment,and/or a public reaction that impedes devel-opment of the technology. The new adminis-tration needs to ensure that neither of theseoutcomes occurs.

THE CURRENT SITUATION

Both the states and the federal governmenthave concentrated on nanotechnology prima-rily as an instrument of economic develop-ment. The National NanotechnologyInitiative (NNI) is the federal structure forpromoting the development and use of nan-otechnology. Military applications of nan-otechnology come under the NNI umbrella.

Four federal regulatory bodies—the FDA,the Environmental Protection Agency (EPA),the Consumer Product Safety Commission(CPSC) and the Occupational Safety and

4

Health Administration (OSHA)—have someauthority, in theory, to regulate nanotechnolo-gy materials and products. However, there is awide gap between having legal authority andactually being able to exercise oversight overnano. Exercising oversight requires that thelegal authority is adequate to collect the rele-vant information and to take the steps neces-sary to prevent adverse effects, that technicaland scientific information are sufficient toimplement the legal authorities, that humanand financial resources are sufficient and thatthere is the political will to take action. Theserequirements have, in most cases, not beenmet, although the adequacy of legal authorityvaries widely among programs.

EPA has reviewed some nanomaterialsunder the Toxic Substances Control Act(TSCA). It is also reviewing a nanoscale fueladditive under the requirements of the CleanAir Act and plans to use the FederalInsecticide, Fungicide, and Rodenticide Act(FIFRA) to review the Samsung Silver Washwashing machine, which releases ions—sub-nano-size particles of silver—as an anti-micro-bial. EPA’s Region IX office has levied a fine of$208,000 on the manufacturer of a computerkeyboard and mouse that use nanoscaleantimicrobials for failing to register underFIFRA (U.S. EPA Region IX Docket#FIFRA-09-2008-0003). FDA has approvedboth medical devices and drugs that utilizenanomaterials. CPSC and OSHA have nottaken any action on nanotechnology. TheNational Institute of Occupational Safety andHealth (NIOSH) has sent teams to nanotech-nology workplaces to document the protective

measures being taken. It has also cooperatedwith several manufacturers to test nanotech-nology monitoring and control methods.

This activity affects only a very small por-tion of the nanotechnology applicationsbeing used and to which people are exposed.There is no official government-wide effortto deal with the regulation of nanotechnolo-gy. The NNI has established a working groupon the environmental and health implica-tions of nanotechnology, but the groupfocuses on research, not oversight. An infor-mal group, the Nanotechnology PolicyCoordination Group, is led jointly by theCouncil on Environmental Quality and theOffice of Science and Technology Policy,both part of the Executive Office of thePresident. Because the group’s meetings andactivities are not public, there is no way toknow how active it is.

Part II of this paper describes actions relat-ing to nanotechnology regulation and over-sight that the government should take in thefirst months of the new administration. Thefocus is the health and safety aspects of nan-otechnology because this is the most impor-tant need. The first sections contain recom-mendations on three subjects—research,coordination and resources—that cut across anumber of agencies. Recommendations arethen provided for each of the regulatory agen-cies. Finally, the second part of the paper cov-ers voluntary efforts and public involvement.Part III of the paper deals with longer-termactions. In each section, the major recom-mendations are underlined. An asterisk indi-cates a priority recommendation.

5Nanotechnology Oversight:An Agenda for the New Administration

Actions required to promote nanotechnolo-gy and to prevent its potential adverse effectsinvolve numerous agencies and variouskinds of efforts. Because of the gaps in ourknowledge and the rapid pace at which thetechnology is evolving, any steps taken nowwill likely have to be modified in the future.However, that does not mean we should notact. It means simply that any actions we takeshould be flexible enough to incorporatenew knowledge.

RESEARCH

The NNI is the coordinating body for feder-al nanotechnology research. NNI does nothave a budget of its own: the $1.5 billionthat comes under its aegis for FY 2009 is thesum of the nanotechnology budgets of adozen agencies (see Appendix B). The agencywith the largest portion of that $1.5 billion isthe Department of Defense (DOD) ($306million), followed by the National ScienceFoundation ($247 million). In FY 2009, $76million, about 5 percent of NNI funds, iscategorized by NNI as research on the healthand environmental effects of nano. An assess-ment of previous NNI research budgets sug-gests, however, that perhaps only a third ofthis 5 percent will support research primarilyaimed at addressing the risks of nanotechnol-ogy (Maynard 2008). Most of the remaining95 percent of NNI funds are being used tofoster nanotechnology applications and toadvance the science of nanotechnology.

The recommendations to improve nano-technology research are as follows:

*1. Increase environmental, healthand safety (EHS) research funding.The most important step that can be taken in

nanotechnology research is to significantlyincrease the dollars going to EHS research.EHS research is the greatest need, and it is thearea that has been most neglected. Althoughstill inadequate, the proposed FY 2009 level fornano EHS funding is an encouraging increaseover the FY 2008 level. Also in the 2009 budg-et, NNI for the first time identifies EHSresearch in a separate category, a step thatshould reduce some of the controversy aboutwhat the government is actually spending.

Neither the recent NNI EHS research strat-egy (www.nano.gov; issued 2/14/08) nor theEPA Nanomaterial Research Strategy (draft,EPA ORD, 1/24/08) contains detailed budgetestimates, which makes it hard to estimate whatthe federal government should be spending onnano-related EHS research. An early version ofthe House Committee on Science andTechnology bill reauthorizing and amendingthe 21st Century Nanotechnology Researchand Development Act required that EHS fund-ing be at least 10 percent of total NNI funding.The 10 percent figure drew support fromindustry and environmental leaders but wasopposed by the Bush White House. There is aquestion of the availability of competentresearchers, but additional funds will attractresearchers and encourage them to apply theirexpertise to nanotechnology. A reasonable tar-get is to increase FY 2009 funding to $100 mil-lion and FY 2010 funding to $150 million.

2. Require a peer-reviewed EHSresearch plan. The effectiveness of EHSresearch is a function not only of the quantityof dollars spent but also of the quality and rel-evance of the research undertaken. As AndrewMaynard of PEN (2006, p.5) has said, “Thefederal government needs to assume top-down,

7Nanotechnology Oversight:An Agenda for the New Administration

II. WHAT NEEDS TO BE DONE

* Priority

authoritative oversight of strategic risk-basedresearch.” The 21st Century NanotechnologyResearch and Development Act of 2003requires that NNI issue a general strategicresearch plan and update that plan every threeyears. The act should be amended to similarlyrequire an EHS strategic plan and to requirethat the plan be developed with stakeholderinput, be peer reviewed and be subject to pub-lic comment before being made final. The EHSstrategic plan must have clear goals and a work-able road map for how to achieve those goals.The House bill referenced above would requireNNI to issue an EHS plan. An EHS researchplan issued voluntarily by NNI in 2007 waswidely condemned as inadequate by both con-gressional lawmakers and scientists. A revisedplan, issued in February 2008, was somewhatimproved but still lacked details about how thegoals would be accomplished.

*3. Strengthen National Nano-technology Initiative (NNI) coordi-nation. For the research plan to be effective,NNI needs to have greater ability to direct andcoordinate agency expenditures. At present, itrelies on cajoling the agencies and on whatev-er influence it can exert over the Office ofManagement and Budget (OMB). OMB actsas the president’s agent in putting together thefederal budget, and thus is the only real sourceof power with regard to budgeting. The presi-dent should direct OMB to ensure that indi-vidual agency nanotechnology EHS budgetrequests are consistent with the NNI EHSplan. During the annual budget review, NNIshould be authorized to make recommenda-tions to OMB for switching funds amongagencies and programs. Consideration shouldbe given to providing a lump sum of moneythat NNI could use to jump-start high-priori-

ty research projects. Another option would beto require that one associate director in theWhite House Office of Science andTechnology Policy (OSTP) be responsible forNNI coordination. OSTP’s associate directorsare among the few positions in the ExecutiveOffice of the President that require Senateconfirmation and are therefore subjected tocongressional oversight.

4. Encourage separation of NNIpromotional and oversight func-tions. More than 90 percent of NNI fundsare spent on development and promotion ofnanotechnology, and encouraging the growthof the technology has been the focus of NNI’sefforts. Some environmental groups haveclaimed that this promotional function inter-feres with the function of assuring adequateresearch on and oversight of potential adverseeffects of nanotechnology. Responding to thiscriticism, the NNI, in its 2007 Strategic Plan,established EHS as a separate program com-ponent (National Science and TechnologyCouncil 2007). The establishment of a sepa-rate interagency regulatory coordinatinggroup (see page 9) and a separate EHSresearch plan (see page 7) should prevent theNNI’s promotional function from interferingwith an aggressive program to identify anyEHS problems with nanotechnology.

5. Establish a NanotechnologyEffects Institute. The federal governmentand the nanotechnology industry have a jointstake in improving scientific knowledge aboutthe effects of nanotechnology. This sharedinterest could be embodied in the creation of ascientific research institute devoted to under-standing the effects of nanotechnology. Theinstitute would be modeled on the Health

8

Effects Institute, a joint undertaking of EPAand the automobile industry devoted toresearch on the health effects of the automobile.EPA and/or the National Institute of Environ-mental Health Sciences (part of the NationalInstitutes of Health) should initiate discussionswith major firms involved in nanotechnologyto explore creation of such an institute.

REGULATORY COORDINATION

Many federal agencies are involved in nan-otechnology policy, and many federal lawseither are being applied or could be applied tonanotechnology. The multiplicity of authori-ties can lead to overlaps, gaps and unnecessaryduplication. However, if properly coordinat-ed, the work of the agencies can be mutuallyreinforcing and can save taxpayers’ money.This report makes three proposals for improv-ing coordination.

*1. Establish an Interagency Nano-technology Regulatory Group. Thepresident should establish by executive order aninteragency nanotechnology regulatory group(INREG). The group should be charged with(1) formulating an interagency plan for apply-ing existing regulatory authorities to nanotech-nology, (2) identifying needs for new authority,(3) exchanging information about regulatoryactivities and (4) coordinating with the NNI onresearch needs of the regulatory agencies.Unlike NNI, both the mandate and the mem-bership of INREG would reflect a focus on reg-ulation, whereas NNI is focused on research.The group should be composed of senior-levelregulators from EPA, CPSC and theDepartments of Health and Human Services,of Labor and of Agriculture. Chairmanship ofINREG should rotate among the agencies.Oversight of biotechnology has been handled

primarily through coordination among the reg-ulatory agencies. Some have argued that nan-otechnology should be dealt with in the sameway (see Davies 2006, p.16).

*2. Develop a nanotechnologyplan within each agency. Most of themajor regulatory agencies have multiple com-ponents that are or should be concerned withnanotechnology. If actions are to be coordi-nated among the agencies, they must first becoordinated within the agencies. This can bestbe done if each agency formulates a nanotech-nology action plan. The plans would delineatehow the different parts of the agency will worktogether when dealing with nanotechnologyand would provide a basis for researchers togive regulators the scientific information theyneed. EPA and FDA have already taken initialsteps to formulate agency nanotechnologyplans, although both plans, especially EPA’s,did not demonstrate a sufficiently strong linkbetween research and regulatory functions.

3. Improve intergovernmentalcoordination. Many states have programsto promote nanotechnology as part of theireconomic development. Some of these pro-grams are large; for example, the College ofNanoscale Science & Engineering at theUniversity at Albany - State University of NewYork has 2,300 employees (Bandhold 2008).Many state programs are partially based onfederal funding. Also, several states and locali-ties are considering regulation of nanotechnol-ogy. The city of Berkeley in California passedan ordinance in 2006 requiring reporting bynanofacilities. Better coordination among thefederal agencies involved in nanotechnologyand state and local nano efforts could benefitall parties. The federal government should

9Nanotechnology Oversight:An Agenda for the New Administration

make sure that state and local oversight effortsare properly evaluated and that the lessonslearned are used to inform federal action.NNI should designate a person to track statedevelopment efforts, and INREG shouldassign someone to monitor and interact withstate and local regulatory efforts. These func-tions could expand if they proved useful.

RESOURCE REQUIREMENTS

In recent years, most of the EHS regulatoryagencies have been deprived of the resourcesneeded to perform their basic functions.Therefore, when considering initiatives need-ed to deal with a new challenge such as nan-otechnology, it is necessary to understand thealready serious constraints on agency resourcesand to take steps to enable the agencies to takeon new responsibilities. It is necessary to:

*1. Increase regulatory agencybudgets and staffing. A major increasein the budgets and staffing of the regulatory

agencies is essential if they are to address theproblems of nanotechnology.

FY 2007 budgets (the latest year for whichthere are final budget numbers) for the regulato-ry agencies are as follows: EPA—$7.7 billion;FDA—$1.8 billion; OSHA—$487 million;and CPSC—$63 million. In the abstract, this isa lot of money. However, it is minimal in thecontext of the federal budget or when weighedalongside the agencies’ responsibilities. Table 1puts the agency budgets in two other perspec-tives. It shows how the agency budgets havefared over time, and it controls for inflation.When controlled for inflation, since 1980OSHA’s budget has remained about the same,FDA’s has doubled and EPA and CPSC budgetshave been reduced by nearly half .

There are major disparities among theagencies. The EPA budget is 100 times aslarge as the CPSC budget. The disparities aredue not only to the varying missions of eachagency but also to the vagaries of history andpolitics.

10

TABLE 1. REGULATORY AGENCY BUDGETS IN CONSTANT DOLLARSa

(budget authority in millions of 1982 dollars)

1980 1990 2000 2007 2009b

EPA 6001 4310 4486 3817 3385

OSHA 239 210 226 241 238

FDA 418 471 622 875 845

CPSC 57 28 31 31 38

a. Actual budget authority, adjusted by Consumer Price Index (CPI-U) for January of the relevant year.b. 2009 from the president’s proposed budget (proposed, not actual), adjusted for January. 2008 CPI-U.

Source: Office of Management and Budget

EPA is by far the largest of the four agen-cies. Its budget is larger than that of FDA,OSHA and CPSC combined. EPA also hasthe broadest mandate of any of the four agen-cies, but even more relevant is that EPA, unlikethe other regulatory agencies, has major func-tions in addition to its regulatory activities.EPA has a large science component that doesboth applied and basic research. It providesfunding and technical assistance for construc-tion of waste-treatment facilities and for theoperation of state pollution control agencies. Ithas 10 regional offices. Although EPA’s respon-sibilities have expanded, its budget, as illustrat-ed in Table 1, has shrunk. In constant dollars,EPA’s budget is significantly less than it was inthe early 1970s, before it was given such majorresponsibilities as TSCA, the Superfund pro-gram and implementation of the 1990 CleanAir Act amendments.

FDA’s budget, unlike the budgets of theother three agencies, has increased in recentdecades. However, most of that increase isattributable to user fees, which are dedicated topre-market reviews of drugs and other prod-ucts. As Michael Taylor, a former FDA officialand now a professor at George WashingtonUniversity, has observed, “FDA lacks theresources it needs to build its own nanotechnol-ogy expertise, to develop the safety testing pro-tocols and detection methods needed to evalu-ate new nanotechnology products, to conductits own risk research, to gather the necessarypre-market data required to get ahead of com-mercialization and to oversee products afterthey have entered the market” (Taylor 2006, p.7). Taylor notes that for FDA to be able to dowhat it was doing in 1996 and to continue thenew activities mandated for it since then, theagency’s 2007 budget would have to be morethan 50 percent greater than it is (ibid.).

OSHA’s problems are largely due to poli-tics. Protecting workplace safety is essential,but OSHA has been largely beholden to oneconstituency—labor unions—a constituencytied to one of the country’s two major politi-cal parties, the Democrats. In recent decades,neither the unions nor the Democrats havefared particularly well, and neither hasOSHA. If OSHA is to take on the task of pro-tecting workers from excess exposure to nano-materials, it will need more resources, regard-less of which party wins in 2008.

CPSC does not have the money, expertiseor regulatory tools to deal with nanotechnolo-gy. At present, its main function is to serve asan excuse for not regulating consumer prod-ucts. Legislation now moving throughCongress would help CPSC and may includefunding earmarked to deal with nanotechnol-ogy. But the legislation is only a band-aid on agaping wound. The new administration andCongress will have to decide whether they areserious about the safety of consumer products.If they are, they must enact legislation thatgives the agency greater authority to preventthe marketing of dangerous products ratherthan to recall them after they are in people’shomes. The commission form of agency ruleis a prescription for cumbersome decisionmaking and muddled responsibility. CPSCwill also require greatly increased resources.

It is beyond the scope of this paper to sug-gest what the budgets of the regulatory agen-cies should be. It is important to point out,however, that the actual dollars consumed bythe agencies are a very small part of the feder-al budget. The combined total FY 2009 pro-posed budgets for the four agencies are about10 percent of the budget of the Department ofAgriculture. The total of the budgets of allfour agencies equals 3 percent of the cost over-

11Nanotechnology Oversight:An Agenda for the New Administration

run of DOD weapons procurement (see GAO2008). Nanotechnology is a very small por-tion of the EPA and FDA budgets, andOSHA and CPSC are currently spendingalmost no money on nano.

There are many needs beyond resources.There are specific actions that should be takenby each of the regulatory agencies. These aredescribed below, starting with EPA.

ENVIRONMENTAL PROTECTION

AGENCY

EPA is central to nanotechnology oversight inpart because it administers TSCA, the onlylaw that, at least potentially, could provideoversight for nanotechnology in general .

TSCA is intended to oversee all chemicalsubstances, and nanomaterials are chemicalsubstances. However, the act has a number ofserious defects and badly needs to be amend-ed (see Section III). It has been characterizedas “toothless” and “gutless,” but it still hassome functioning parts that can be usefullyapplied to nano.

*1. Define nanomaterials as“new” chemical substancesunder TSCA. One of the notable weakness-es of TSCA is that most of its authority to reg-ulate existing chemical substances (as contrast-ed with new chemical substances) has been ren-dered inoperative by court decisions and by thelanguage of the act. If nanomaterials are notdefined as new chemical substances, they arenot, in practical terms, subject to most of theTSCA regulatory authorities.

In 2007, EPA issued a policy paperannouncing that the agency would not takesize into account when deciding what sub-stances were new chemicals. Since size is thefactor that defines a nanomaterial, and it is

size that makes nanomaterials behave differ-ently, and perhaps more dangerously, thannormal-size substances, the EPA announce-ment amounted to saying that there wouldnot be a TSCA nanotechnology program.Two points should be noted, however. First,the agency’s interpretation of how TSCAdefines a new chemical may be legally correct:the act’s definition talks only about molecularstructure and not about any other definingcharacteristics. Second, because the molecularstructure of some nanomaterials is unique,some of them will be included in the newchemicals category. However, the majority ofnanomaterials will not be included becausethey have the same chemical composition andstructure as some larger material (e.g., silver,titanium dioxide, carbon).

Nanomaterials must be defined as newchemical substances if TSCA is to serve as thevehicle for dealing with their potential adverseeffects. There are two ways in which this couldbe done. First, the new administration couldsubmit to Congress legislation amendingTSCA’s definition of “chemical substance.”There would probably be some industryopposition to this, but how much is not clear.If, for political or other reasons, legislationseems undesirable, an alternative would be forthe administration to promulgate a “signifi-cant new use rule” (SNUR) under TSCA. Theact gives broad authority to cover categories ofchemicals under such a rule and, once cov-ered, the chemicals are essentially consideredto be new chemicals. The disadvantage of sucha rule is that it would almost certainly be test-ed in the courts, which might cause a lengthydelay in implementing the rule.

Neither the legislative amendment nor theSNUR option is a perfect solution, but thecentral importance of TSCA for nanotechnol-

12

ogy oversight makes it urgent to take oneaction or the other. Failure to do so wouldmean that there was no existing law that couldbe used as a general oversight mechanism fornanotechnology.

2. Promulgate a TSCA informationcollection rule. In January 2008, EPA ini-tiated a voluntary program to collect fromnanotechnology manufacturers informationabout the kinds of materials they are produc-ing, what types of practices they are using toprevent adverse effects, and what is knownabout the effects of the materials. EPA statedthat it needs such information to decide whatkind of regulatory program, if any, it shouldinstitute to deal with nanomaterials.

The goals of the EPA voluntary programare laudable, but it is not clear how manyfirms will participate, how representative ofthe industry they will be or how much infor-mation participants will choose to submit.EPA would be much more likely to get theneeded information by promulgating a section8 rule under TSCA. TSCA section 8(a) allowsEPA to require manufacturers to report on theuses, risks, amount manufactured, by-prod-ucts and other information about a chemicalor category of chemicals.

Despite its drawbacks, the voluntary pro-gram should be retained for at least two reasons.First, it will encourage more open informal dis-cussions between EPA and manufacturers thanif the manufacturers were only responding to arule. Second, TSCA section 8(a) excludes smallmanufacturers. Thus, the voluntary programcould serve as a vehicle to get information fromsmall nanotechnology firms.

EPA is responsible for implementing otherlaws that are either already being used to reg-ulate specific uses of nanomaterials or will

have to deal with specific aspects of nanotech-nology in the near future. Recommendationsregarding these are discussed below.

3. Expand regulation of anti-microbials under the federal pes-ticide law. FIFRA regulates anti-micro-bials, among other things. Last year, EPAreversed a previous decision and announcedthat it would require the Samsung Silver Washwashing machine to register under the act. Themachine releases ions—sub-nano-size particlesof silver—into each wash load in order to killbacteria and other microbes. However, theEPA decision was phrased in the narrowestpossible terms, thereby excluding the manyother nano-utilizing anti-microbial productsnow on the market. These products mayinvolve significant human exposure andshould be reviewed in the same way as otheranti-microbials are. Such an action wouldrequire only implementation of the existinglaw; no new legislation would be needed.

*4. Promote “green” nanotech-nology. Nanotechnology can improve theenvironment in many ways. It can save energyby making materials lighter or processes lessenergy intensive; it can improve the effective-ness and efficiency of environmentally usefulproducts such as solar panels and car batteries;it can substitute safer materials for more toxicchemicals; and it can be used for environmen-tal remediation and pollution control. PEN hasoutlined a variety of measures to promote greennanotechnology (Schmidt 2007), includinglaunching a “Green Nano Awards” program,using federal facilities as test beds and employ-ing federal procurement to increase demand forgreen nano products. EPA should take the leadin many of these areas. The NNI should exam-

13Nanotechnology Oversight:An Agenda for the New Administration

ine whether it can give greater priority to thedevelopment of green nanotechnology andshould publicize what it has done to foster suchdevelopment.

5. Evaluate the application ofother EPA statutes to nanotechnol-ogy. Many EPA laws in addition to TSCAand FIFRA potentially apply to nanotechnol-ogy. The disposal of nanomaterials and prod-ucts containing them comes under thepurview of the Resource Conservation andRecovery Act (RCRA) and the Compre-hensive Environmental Response, Compen-sation, and Liability Act (CERCLA) (seeBreggin and Pendergrass, 2007). The CleanAir and Clean Water Acts will have to beemployed to avoid adverse environmentaleffects from nanotechnology, although at thepresent time the lack of information abouteffects and the lack of detection and controltechnologies make it difficult to use these actsto deal with nanotechnology. EPA should ana-lyze the short-term possible uses of the air andwater permitting processes to foster disclosureand to encourage use of good managementpractices for nanomaterials.

EPA will need to make many internalchanges to address the environmental prob-lems of the 21st century (see Davies 2007). Itwill need to better integrate its existing pro-grams and to develop a forecasting capabilityso that it can prepare for problems and devel-op strategies for dealing with them. Section IIIcontains a further discussion of this subject.

FOOD AND DRUG ADMINISTRATION

The FDA has broad regulatory authority overa range of products, including drugs, food,medical devices, dietary supplements and cos-metics. Nanomaterials are now in products in

all these categories, and the application ofnanotechnology to these areas is likely to growrapidly in the coming years. There are at leastthree major steps that FDA should take todeal with the increasing use of nanotechnolo-gy in the products it regulates. Each willrequire additional resources. The three recom-mendations are as follows:

1. Establish criteria for determin-ing which nanomaterials are“new” for regulatory purposes.Similar to TSCA, many important FDA regu-latory authorities are triggered by a substancebeing categorized as “new.” FDA needs toestablish criteria and provide guidance to theindustry about when nanomaterials are notthe same as materials that are already listed inFDA’s GRAS (generally recognized as safe)food additive and food packaging regulationsor that have been reviewed under theCosmetic Ingredient Review (Taylor 2006, p.8). The agency criteria clarifying what is“new” for legal and regulatory purposes “pre-sumably would include functional propertiesthat relate to the likelihood that the safetyprofile of the nanotechnology version wouldbe different from the conventional one. Suchcriteria would be helpful for all categories ofFDA-regulated products as a guide to deci-sions about the need for toxicity testingbeyond what already exists on the convention-al form” (ibid.).

*2. Collect information on safetytesting, forthcoming products andadverse events. At present, thereare major gaps in FDA’s authorityto require that regulated indus-tries provide the information itneeds to assess safety risks.

14

These deficiencies need to beremedied.

FDA may be able to obtain some of theinformation it needs on a voluntary basis. Forexample, an existing FDA regulation requirescosmetic companies to compile safety substan-tiation data on their ingredients, but it does notgive FDA access to those data. FDA should askthe companies to voluntarily submit their safe-ty data on all cosmetic products making nan-otechnology claims or containing nanomateri-als (Taylor 2006, p. 9). Similarly, FDA shouldwork with the food industry to obtain safetydata on food uses of nanotechnology.

FDA should not, however, have to rely onvoluntary industry compliance in order toobtain data on the safety of the products thatit regulates. The agency needs legal authorityto require disclosure of specified information,including safety information, on emergingtechnologies and products that are under itsjurisdiction. It should be given rule-makingauthority to establish interim pre-market noti-fication mechanisms to address emerging andnovel technologies. Its inspection authorityshould be expanded to include access to allsafety information (Taylor 2006, p. 10).

FDA and the other regulatory agenciesalso need to have legal authority to obtainhealth and safety data regarding a productafter it has been marketed. Even the mostthorough pre-market testing and review canmiss important adverse effects, as demonstrat-ed by recalls of drugs and medical devices,which undergo rigorous pre-market review.FDA should have authority to require post-market monitoring and surveillance of prod-ucts under its jurisdiction. It also should havebroad authority and adequate resources todevise mandatory adverse event reporting sys-tems that are appropriate for each product cat-

egory and are the least burdensome approachnecessary to achieve the oversight purpose(Taylor p.10).

3. Regulate cosmetics and dietarysupplements. Cosmetics and dietary sup-plements are important applications of nan-otechnology that are of specific concern toFDA because they involve high exposure topeople and are largely unregulated for safety.Section III discusses legislation to deal withthese products.

OCCUPATIONAL SAFETY AND

HEALTH ADMINISTRATION AND

NATIONAL INSTITUTE OF

OCCUPATIONAL SAFETY AND HEALTH

In theory, NIOSH is supposed to provide thescientific and technical information thatOSHA uses for its regulations. In practice,OSHA has often ignored NIOSH. However,NIOSH, conceptually a scientific organiza-tion, has become a quasi-regulatory bodybecause its guidelines and recommendationsare frequently used in litigation and havethereby acquired much the same force as reg-ulations. The NIOSH-OSHA relationship isimportant in part because NIOSH hasdevoted considerable attention to nanotech-nology, whereas OSHA has largely ignoredthe subject.

1. Communicate to workers andfirms about nanotechnology.OSHA should use its Web site, publicationsand other materials to communicate informa-tion about nanotechnology’s potential healtheffects and measures for controlling exposure.The OSHA Web site should link to NIOSH’sinformation about nanotechnology. OSHAshould include nanotechnology as one of the

15Nanotechnology Oversight:An Agenda for the New Administration

subjects to be covered in its training grants tounions, universities and employers. In manyworkplaces, Material Safety Data Sheets(MSDSs), an important form of communica-tion with workers, do not distinguish betweenthe macro form of the material and the nan-otechnology form (e.g., the MSDS for silver isused when a worker is actually exposed tonanosilver). This practice is misleading anddeceptive and should be discontinued.MSDSs in nanotechnology workplaces shouldbe required to be specific to nanomaterials.

*2. Use existing OSHA regulationsto deal with nanoparticles. The haz-ard communication standard can be used torequire MSDSs for nanomaterials. The labora-tory safety standard should be extended toinclude nanomaterials. The respirator stan-dard may be applicable under certain circum-stances. When practical equipment becomesavailable, OSHA should require monitoringof nanoparticle levels in the workplace.

3. Issue OSHA standards fornanomaterials. The standards shouldinclude exposure limits for nanoparticles andgood practices for preventing worker expo-sure. Enough information is available fromNIOSH, international organizations andEuropean practice to make the standards fea-sible and defensible. In fact, NIOSH hasalready issued draft exposure limits for titani-um dioxide nanoparticles and is working onadditional standards (see www.cdc.gov/niosh/review/public). OSHA also could requiremedical surveillance of workers who areexposed to nanoparticles, but the lack ofknowledge about what adverse effects to lookfor probably makes this suggestion premature.

CONSUMER PRODUCT

SAFETY COMMISSION

About half of the products in PEN’s inventoryof nanotechnology consumer products fallunder the jurisdiction of CPSC (Felcher, forth-coming, from which much of this section isdrawn). However, CPSC has been renderedalmost incapable of doing anything, and cer-tainly incapable of coping with a complex tech-nology that is used in a broad range of productsand whose effects are largely unknown. TheConsumer Product Safety Act, passed in 1972,has been crippled with amendments that,among other things, prohibit the agency fromimposing mandatory safety standards if theindustry agrees to write its own voluntary stan-dards and from saying anything to the publicabout a product without the approval of themanufacturer. The agency has no authority torequire pre-market testing and must thereforerely on post-market recalls. The commission’sability to police the market and enforce its reg-ulations has been severely compromised overthe past few decades. The number of productssold in the United States, many of them manu-factured overseas, has proliferated, whileCPSC’s resources have dwindled. CPSC’sbudget was cut in half between 1977 and 1983and has stayed at roughly the 1983 level. Thestaff, which was 900 in FY 1981, had beenreduced to 393 by FY 2007.

Legislation pending in Congress wouldreverse some of the erosion in the agency’sauthority, and it is likely that the agency willreceive significantly more money in the FY2009 budget. The Senate version of the CPSCReform Act of 2008 (S. 2663) authorizes $1million for research on the safety of nanotech-nology in products. Using its new resources,CPSC should take at least two steps.

16

1. Hire new staff to study nan-otechnology exposure. CPSC hasfocused primarily on acute hazards, in partbecause it lacks the scientific expertise to dealwith chronic hazards. With respect to nan-otechnology products of concern, such asinfant pacifiers and teething rings, CPSCshould analyze whether there is likely to beexposure to nanomaterials from such productsand, if so, what short- and long-term healtheffects are associated with the exposure.

2. Create a Chronic HazardAdvisory Panel (CHAP) for nan-otechnology products with signifi-cant exposure. The Consumer ProductSafety Act prohibits CPSC from promulgatinga safety rule related to a chronic hazard with-out first establishing a CHAP. A CHAP con-sists of seven experts drawn from a list of nom-inees compiled by the National Academies.The CHAP advises CPSC about the risk ofthe products in question. If CPSC finds thatthere is significant exposure to nanomaterialsfrom certain products, it should convene aCHAP to give an opinion about the risk from

these products. If the CHAP advises that therisk is unreasonable, CPSC can either takeaction itself or request that EPA take actionunder TSCA.

VOLUNTARY EFFORTS

The success of nanotechnology and the pre-vention of its adverse effects ultimately restwith the private sector. No amount of govern-ment policing will work without cooperationfrom nanotechnology firms. However, itwould be a mistake to rely totally on the freemarket. Past history and current evidenceshow that there are always some irresponsiblefirms, and that even the most responsiblefirms benefit from government regulation.Voluntary efforts are a supplement to, not asubstitute for, government oversight.

*1. Use the DuPont–EnvironmentalDefense framework as a basis foranalyzing nanotechnology risks.A solid basis for voluntary cooperation by theprivate sector has been established by DuPontand Environmental Defense. The two organi-zations, in consultation with many others, for-

17Nanotechnology Oversight:An Agenda for the New Administration

FIGURE 2. ENVIRONMENTAL DEFENSE - DUPONT NANO RISK FRAMEWORK

Iterate

Assess, prioritize & generate data

DescribeMaterial &Application

ProfileLifecycle(s)

Properties

Hazards

Exposure

EvaluateRisks

Assess RiskMgmt

Decide,Document &

Act

Review &Adapt

Source: www.nanoriskframework.com

mulated a detailed framework for examiningthe health and environmental effects of ananoproduct. The framework (see Figure 2)was tested on several products made or usedby DuPont, and DuPont has made its usemandatory in the development of newnanoscale materials within the company.

The framework should be embraced by theNanoBusiness Alliance and be incorporatedinto the Responsible Care program of theAmerican Chemistry Council. The Depart-ment of Commerce could meet with theseorganizations and encourage them to use theframework.

In addition, the insurance industry shouldconsider making adoption of the framework acondition for insuring nanomanufacturers.The insurance industry has, for the past sever-al years, shown leadership in expressing con-cern about the potential adverse effects of nan-otechnology. Important reports about nanohave been issued by Swiss Re (2004) and byLloyd’s (2007). The new administrationshould meet with insurers and perhaps withstate insurance regulators to explore how theinsurers can best deal with nano and how thefederal government could support their efforts.

2. Issue a nanotechnology hand-book for small businesses. Many ofthe companies involved with nanotechnologyare small start-up companies, often springingfrom university research efforts. These com-panies need help in thinking about testingrequirements, legal constraints and life-cycleanalysis of nanotechnology products. Therealso may be opportunities for encouragingsmall companies to invest in green nano. TheSmall Business Administration, working withEPA and trade associations, should produceand disseminate a handbook dealing with

these matters. The handbook should beaimed at small nanotechnology firms andshould be available on the Internet.

PUBLIC INVOLVEMENT

The basic problem with public involvement isthe scarcity of people who want to listen.Most officials do not really want to listen tothe public, most members of the public arenot really interested in listening to officials orexperts, and representatives of interest groupsare much more interested in being heard thanin listening. One of the great virtues of demo-cratic elections is that they give politicians anincentive to listen to the public. The listeningproblem will not be fixed in 100 days, andprobably not in 100 years, but there are stepsthat can and should be taken to involve thepublic in nanotechnology policy.

*1. Give the public more informa-tion about nanotechnology. Morethan three-quarters of the American publicknow almost nothing about nanotechnology.There is no guarantee that knowing moreabout the technology will make the publicmore supportive of it (Kahan, et al. 2008), butknowing more could make their views morereasoned and less subject to bias and misinfor-mation. The National Science Foundation(NSF) has invested in museum programs andother methods of informing the public aboutnanotechnology, and it should increase itsefforts, using television, the Internet and otherappropriate media. NSF should also considerworking with organizations such as AmericaSpeaks, which have experience in engaging thepublic on important policy issues.

Two more specific ways of informing thepublic are labeling and use of the ToxicsRelease Inventory (TRI). Some consumer

18

groups have urged the government to requirethat products containing nanomaterials belabeled to show that they contain nanomateri-als. If such labeling were required, consumerswould be able to know which products con-tain nanomaterials. Buyers who wanted toavoid exposure to nanomaterials would bebetter able to do so, and if adverse effects wereproduced by a nanomaterial there would be abetter chance of detecting it. On the otherhand, determining what should be labeled,enforcing the labeling requirement andresponding to questions arising from thelabels would be costly for manufacturers andthe government. Manufacturers worry thatlabeling would discourage buyers from pur-chasing their products. The new administra-tion should convene an interagency group toinvestigate the feasibility and desirability oflabeling nanotechnology products. The groupshould report its findings within one year.

The TRI was established in 1986 as part ofthe Emergency Planning and Community-Right-to-Know Act. It requires that owners andoperators of certain facilities annually reportthe amounts of certain listed toxic chemicalsthey release to the environment. Approximately650 chemicals are on the TRI reporting list.EPA makes these reports public. A recent PENreport (Breggin and Porter 2008) examined theapplicability of TRI to nanomaterials and con-cluded that TRI would be applicable to nano-materials, while also observing that “it is quitepossible … that other mechanisms would bepreferable to TRI as a vehicle for disclosureabout nanomaterials” (ibid. p. 3).

The usefulness and feasibility of applyingTRI to nanomaterials should be tested byapplying such a provision to all or selected fed-eral facilities. A number of federal facilities thatuse nanomaterials are covered by TRI (see ibid.

p. 6). The idea of using federal facilities, espe-cially DOD facilities, as a way of testing nan-otechnology policies may have wide applicabil-ity. Methods for monitoring, control and dis-posal of nanomaterials could be tried at federalfacilities, and the results could be used to for-mulate policies applicable to the private sector.

2. Obtain the public’s views aboutnanotechnology. Many of the policies fordealing with new technologies entail questionsof ethics and values. The experts on these sub-jects are members of the general public, so it isimportant to obtain their views. Also, as notedearlier, the public is in a position to block devel-opment of new technologies, so it is necessaryfor policy makers to know what people arethinking and to give the public an opportunityto express opinions and to be heard.

The old ways of engaging the public, such aspublic hearings, never worked very well andprobably work less well today. Experimentationand creative thinking about new forms of pub-lic participation are necessary and are takingplace to some extent. For example, ArizonaState University, with funding from NSF, is con-vening six citizen panels to consider how best tomanage nanotechnology and other new tech-nologies. The panels will engage in Web dia-logues with experts and face-to-face meetingswith each other. PEN also has experimentedwith a Web-based dialogue on nanotechnology.In any form of public participation, it is impor-tant that there be some route by which the pol-icy makers receive the views of the public.

*3. Convene a stakeholder dia-logue. Many of the initiatives described inthis paper would benefit from focused reviewand discussion by the major stakeholdergroups—big and small nanotechnology firms,

19Nanotechnology Oversight:An Agenda for the New Administration

20

environmental and consumer groups, laborunions, scientists and public officials.Stakeholder dialogues could improve the quali-ty of the proposals, facilitate their implementa-tion and produce new recommendations.

In late 2007, PEN, in conjunction withthe Meridian Institute, interviewed nan-otechnology stakeholders to ascertain theirinterest in a dialogue on nanotechnologyoversight. The general response in the inter-views was a willingness to participate in a

dialogue but a lack of intensity or commit-ment. The absence of any pressure or dead-line to drive the dialogue contributed to thelukewarm response. This attitude likelywould change if the new administrationendorsed a dialogue and provided both anagenda and some deadlines. If the stakehold-ers were convinced that the governmentmight act on their recommendations, a dia-logue could make a major contribution tonanotechnology policy.

This report has outlined a variety of initiativesthat can and should be taken when a newadministration takes office. Some of the initia-tives, such as increasing the resources of the reg-ulatory agencies, will have a short-term impactbut will require several years to reach fullfruition. Two other kinds of initiatives that areinherently longer term will also require theattention of the transition team and the newadministration. These are enacting new legisla-tion and preparing for the next generation ofnanotechnology and other technologies.

NEW LEGISLATION

It is often said that the American system is agovernment of laws, and in fact laws are whatdrive the actions of the government agencies.Most of the U.S. laws dealing with environ-ment, health and safety are antiquated andweak. The last major environmental law wasenacted almost 20 years ago. TSCA, the onlylaw applying generally to nanomaterials, hasnot been significantly changed in more than30 years. As a result, the United States is try-ing to deal with 21st-century problems usingmid-20th-century tools. Current laws are notadequate to deal with nanotechnology or withmany of the other environment, health andsafety problems the nation faces.

One option for improving nanotechnologyoversight would be to adopt legislation focus-ing exclusively on nanotechnology. In manyways, it would be neater and perhaps moreeffective to try to enact such legislation. Whatsuch a law might contain has been outlinedelsewhere (see Davies 2006). However, itwould take time to enact such a law, and theproblems of committee jurisdiction in bothchambers of Congress would be formidable.

Thus, the discussion that follows deals withindividual laws aimed at specific subjects, nota comprehensive nanotechnology law. It doesnot deal with drugs, pesticides and otherproducts adequately covered by existing law.

The legislation recommended below focus-es on nanotechnology, but it is impossible tomake recommendations for nanotechnologywithout dealing with the general shortcom-ings in individual existing laws. For example,it is almost impossible for EPA to require ade-quate risk information for new chemicalsunder TSCA. This problem requires a generalfix that is applicable to all new chemicals; itwould make no sense to fix the problem fornanomaterials alone.

*1. Toxic Substances Control Act.Some argue that TSCA is so flawed that it can-not be salvaged. We disagree. The statute wentthrough a tortuous gestation, marked by oppo-sition from within the administration that pro-posed it and from outside groups, and by a lackof any strong support. We believe that TSCAcan be a valuable tool for dealing with nan-otechnology and other new technologies ifsome of the scars of its gestation are fixed. It isthe only broad environmental statute that tran-scends the flawed air-water-land basis for deal-ing with environmental problems.

In the EPA section we recommended eitherenacting a significant new use rule or amend-ing the legislative authority relating to TSCAto make clear that nanomaterials are coveredas new substances. Appendix C gives specificlegislative language for doing this and otherchanges recommended here.

Other changes in TSCA are necessary. Thefirst is to remove the catch-22 that requires

21Nanotechnology Oversight:An Agenda for the New Administration

III. THE LONGER TERM

EPA to show that a new chemical poses a riskbefore the agency can obtain enough informa-tion to determine whether it actually poses arisk. The second change is to remove the con-ditions and requirements that guarantee thatEPA can never regulate an existing substance.The American legal tradition requires that reg-ulatory actions be fair, justified and appliedwith due process. However, the TSCA condi-tions applicable to regulating existing sub-stances were put into TSCA not to make it fairand legal but to make it impotent.

One set of needed TSCA changes, thoseconcerning confidential business information(CBI) and data sharing, may command broadsupport. The current language of TSCAmakes it easy for manufacturers to label data“Confidential” and severely constrains EPA’sability to share CBI data with other entities.As a result, much information submittedunder TSCA is not available to states, othercountries or the public. The remedy isdescribed in Appendix C.

*2. Cosmetics. The portion of theFFDCA providing FDA with regulatoryauthority over cosmetics is an empty vessel.Indeed, its basic purpose is to provide a justi-fication for not regulating cosmetics. Theindustry maintains a registry that, accordingto the industry, contains test data showing thesafety of the active ingredients used in cosmet-ic products, but this information is not pro-vided to FDA. The FFDCA should be amend-ed to require that the data in this registry besubmitted to and reviewed by the FDA. FDAshould also be authorized to forbid marketingof any cosmetic containing an ingredient thatis not safe or for which adequate test data arenot available. This should not impose any sig-nificant additional burden on the industry if,

as the industry maintains, such testing alreadyis being performed.

Another needed change in the FFDCA isto make clear where and how to draw the linebetween a drug and a cosmetic. That line isblurry now and is likely to be further blurredby the use of nanomaterials.

*3. Dietary Supplements. In 1994,Congress passed the Dietary SupplementHealth and Education Act (DSHEA). The actis another example of anti-regulation law mas-querading as something different. Facingintense political pressure from the dietary sup-plement industry, with the passage of DSHEACongress prohibited FDA from imposing pre-market testing or approval on dietary supple-ments (vitamins, herbs, etc.) and placed theburden of proof on FDA to prove that a sup-plement is unsafe. Some supplements arebeing developed using nanotechnology thatmay allow them to reach the brain, the placen-ta or other vulnerable parts of the body.Toxicity research on these products has notbeen done, so it is not known what resultsmight ensue from the use of such products,but a potentially hazardous situation exists(Schultz and Barclay, forthcoming).

This problem requires a legislative fix, whichwould include greater regulatory authority forFDA, greater information about the dietarysupplement products being developed and moreresources for FDA to carry out its mission inthis regard. A forthcoming PEN study providesdetailed recommendations (ibid.).

4. Other Changes to the FFDCA. Inthe FDA section above, we outlined otherchanges that need to be made in FDA’s author-ity. These include giving FDA authority toreview safety tests on food and cosmetic ingre-

22

dients and to require post-market monitoringand surveillance of many types of products.

5. NNI. The budget authorizations in the21st Century Nanotechnology Research andDevelopment Act of 2003, which is the statu-tory basis for the NNI, expire in October2008. It is likely that the act will be reautho-rized before the new administration takesoffice. Whether or not it has been reautho-rized, the act should be amended to include arequirement for an EHS research plan and tostrengthen NNI’s coordination powers (see #2and #3 under Research in Section II above).

NEW TECHNOLOGIES,

NEW OVERSIGHT

In the 21st century, technological innovationwill almost certainly accelerate from its alreadyrapid pace. Neither the U.S. government norany government elsewhere in the world is pre-pared to deal with the adverse effects and unan-ticipated consequences of the new technologies.If we do not prepare ourselves, we run a highrisk of doing irreversible damage to humankindand to our planet, and of ending up not with aworld made better by technology but with livesthreatened and impoverished by the world wehave created. Nanotechnology provides boththe necessity and the opportunity to startaddressing these questions.

*1. Improve the government’sforecasting ability. At present we haveonly a vague picture of the technologicaldevelopments that lie a decade or two ahead.Agencies such as EPA, the Department ofCommerce and the Department of Agri-culture need to create and nurture offices thathave the specific mission of identifying tech-nological trends. This would give government

and society some lead time to think aboutwhat the trends mean and what needs to bedone to ensure that the new technologiesbring the maximum benefit and the fewestadverse effects to society.

Second, Congress needs better ways toevaluate and anticipate scientific and techno-logical developments. The congressional cul-ture is dominated by lawyers, who have littleor no training in science. This makes it espe-cially important that the Congress have accessto sources whom it trusts and who have theresponsibility to tell the legislators what theyneed to know about scientific and technologi-cal developments.

Congress once had such an organization,the Office of Technology Assessment (OTA).Unfortunately, in a move of breathtaking stu-pidity, in 1995 the Congress removed allfunding for OTA, thus ending its existence(see Morgan and Peha 2003). Congress shouldeither revive OTA by providing the modestfunding (approximately $20 million per year)used by the OTA when it was operational orcreate a new agency to perform the functionsthat OTA used to perform.

2. Create new forms of oversight.The existing forms of oversight are outdatedand inadequate. The contrast between theinflexible, compartmentalized oversight sys-tems of the past century and biotechnology,climate change, nanotechnology and otherchallenges of the 21st century is stark.

Proposals for new types of oversight havebeen heavily influenced by the free marketideology of the 1980–2007 era. They largelyentail giving more responsibility and flexibili-ty to private firms (see, for example, Fiorino2006 and Kamarck 2007). There is much thatis useful in these proposals, but they are not

23Nanotechnology Oversight:An Agenda for the New Administration

adequate to deal with the technological chal-lenges of the 21st century. Given the poten-tially great impact of a failure to identify andcontrol an adverse effect of nanotechnology,should we really leave its identification andcontrol in the hands of those who are produc-ing it?

*3. Create a commission on over-sight of new technology. The presi-dent should appoint a commission to formu-late a blueprint for new forms of oversight.Commission members should include scien-tists, policy makers, business representatives,consumers, and environmentalists. It shouldhave a fixed life span, perhaps three years. Itsreport should provide guidance for govern-ment oversight over the next few decades. Thecommission should have a broad mandate toallow it to consider all forms of technology andall forms of change—new legislation, institu-tional changes and private sector initiatives.

The commission will need to address thefunctions entailed in oversight, including howto identify the universe of concern, how tonarrow the subjects of oversight to a manage-able number, how to collect information onthe targets of oversight (risks and benefits),how to manage potential dangers from new

technologies, how to get public input intodecisions about technologies and how tostructure surveillance activities so that newfindings about a technology can be rapidlyidentified and acted upon.

Commission members will need to beopen to new approaches and ideas. Can over-sight be linked to the patent system? Canmanufacturers take the initiative to proposerestrictions, labels and other ways of manag-ing a technology? What would an internation-al surveillance system look like? Do we need anew technology oversight agency? ShouldEPA and the Congress jettison the air-water-land approach to environmental protection?Are there market-based incentives to encour-age greener products?

* * * * *

Scientists have given and will continue to giveus vast marvels, capable of producing tech-nologies of great power. Each of these marvels,including nanotechnology, comes in a treasurechest of riches and a Pandora’s box of evils.The challenge of the new century and to thenew administration is to use the treasure whilekeeping shut the lid on the Pandora’s box. It isa daunting challenge, but one that can be met.

24

25Nanotechnology Oversight:An Agenda for the New Administration

Bandhold, Stacy, 2008. “Feds, UAlbany formpartnership for nano research,” Troy Record(NY), April 22

Breggin, Linda K., and Read D. Porter, 2008.Application of the Toxics Release Inventory toNanomaterials, Washington, D.C., Project onEmerging Nanotechnologies, Woodrow WilsonInternational Center for Scholars

Breggin, Linda K., and John Pendergrass, 2007.Where Does the Nano Go? End of LifeRegulation of Nanotechnologies, Washington,D.C., Project on Emerging Nanotechnologies,Woodrow Wilson International Center forScholars

Davies, J. Clarence, 2006. Managing the Effects ofNanotechnology, Washington, D.C., Project onEmerging Nanotechnologies, Woodrow WilsonInternational Center for Scholars

Davies, J. Clarence, 2007. EPA and Nanotechnology:Oversight for the 21st Century, Washington,D.C., Project on Emerging Nanotechnologies,Woodrow Wilson International Center forScholars

Elder, Miriam, 2007. “Nanotechnology: Big bangaims to start boom,” Financial Times, Oct. 2

Felcher, E. Marla, forthcoming. The ConsumerProduct Safety Commission and Nanotech-nology,Washington, D.C., Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

Fiorino, Daniel J., 2006. The New EnvironmentalRegulation. Cambridge, MA: MIT Press

Government Accountability Office (GAO), 2008.“Defense Acquisitions,” Washington, D.C.,GAO, GAO-08-467SP

Hart, Peter D. Research Associates, 2007.Awareness of and Attitudes TowardNanotechnology and Federal Regulatory Agencies,Washington, D.C., Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

International Life Sciences Institute ResearchFoundation (ILSI), 2005. “Principles for

Characterizing the Potential Human HealthEffects from Exposure to Nanomaterials:Elements of a Screening Strategy,” Draft Aug. 30

International Risk Governance Council, 2007.“Nanotechnology Risk Governance” Geneva,Switzerland, International Risk GovernanceCouncil

Kahan, Dan, et al., 2008. Biased Assimilation,Polarization, and Cultural Credibility,Washington, DC, Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

Kamarck, Elaine C., 2007. The End ofGovernment … As We Know It, Boulder, CO,Lynne Rienner

Lewis, Sanford, Richard Liroff, Margaret Byrne,Mary S. Booth, and Bill Baue, 2008. “Toxicstock syndrome: How corporate financialreports fail to apprise investors of the risks ofproduct recalls and toxic liabilities,” Availableat: http://www.iehn.org/publications.reports.toxicstock.php. Accessed April 18, 2008

Lindberg, John E., and Margaret M. Quinn,2007. A Survey of EHS Risk ManagemenInformation Needs and Practices amongNanotechnology Firms in the MassachusettsRegion, Washington, D.C., Project onEmerging Nanotechnologies, Woodrow WilsonInternational Center for Scholars

Lloyd’s, 2007. “Risks: Nanotechnology” (availableat www.lloyds.com/emergingrisks)

Luoma, Samuel N., forthcoming. SilverNanotechnologies and the Environment,Washington, D.C. Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

Lux Research, 2006. The Nanotech Report:Investment Overview and Market Research forNanotechnology, 4th ed. New York, N.Y., LuxResearch, Inc.

Macoubrie, Jane, 2005. Informed PublicPerceptions of Nanotechnology and Trust inGovernment, Washington, D.C., Project on

APPENDIX A: BIBLIOGRAPHY

26

Emerging Nanotechnologies, Woodrow WilsonInternational Center for Scholars

Mandel, Gregory N. 2005. “Technology Wars:The Failure of Democratic Discourse.”Michigan Telecommunications TechnologyLaw Review, vol. 11, no. 117

Maynard, Andrew D., 2008. Testimony before theU.S. Congress, House Committee on Scienceand Technology, April 16, 2008 (available at:www.nanotechproject.org)

Maynard, Andrew D., 2006. Nanotechnology:A Research Strategy for Addressing Risk,Washington, D.C., Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

Morgan, M. Granger, and Jon M. Peha, eds.,2003. Science and Technology Advice forCongress, Washington, D.C., Resourcesfor the Future

National Science and Technology Council. 2007.The National Nanotechnology Initiative:Strategic Plan., Washington, D.C., ExecutiveOffice of the President

Schmidt, Karen F., 2007. Green Nanotechnology,Washington, D.C., Project on Emerging

Nanotechnologies, Woodrow WilsonInternational Center for Scholars

Schultz, William B., and Lisa Barclay,forthcoming. A Hard Pill to Swallow: Barriersto Effective FDA Regulation of DietarySupplements Made From Nanotechnology,Washington, D.C., Project on EmergingNanotechnologies, Woodrow WilsonInternational Center for Scholars

Swiss Re, 2004. Nanotechnology: Small Matter,Many Unknowns, Zurich, Swiss Re

Taylor, Michael R., 2006. Regulating theProducts of Nanotechnology: Does FDAHave the Tools It Needs?, Washington, D.C.,Project on Emerging Nanotechnologies,Woodrow Wilson International Centerfor Scholars

World Economic Forum, 2008. “Global Risks2008,” Geneva, Switzerland, WorldEconomic Forum

Zhang, L., et al., 2007. “Nanoparticles inmedicine: therapeutic applications andDevelopments,” Chemical Pharmacology andTherapeutics, advanced online publication, 24October. Available at: www.nature.com.

27Nanotechnology Oversight:An Agenda for the New Administration

APPENDIX B: PLANNED 2009 NNI BUDGET BY PROGRAMCOMPONENT AREA (dollars in millions)

DOD 227.8 55.2 107.7 3.6 12.8 22.1 1.8 431.0

NSF 141.7 62.5 51.6 16.0 26.9 32.1 30.6 35.5 396.9

DOE 96.9 63.5 8.1 32.0 6.0 101.2 3.0 0.5 311.2

DHHS(NIH) 55.5 25.4 125.8 5.9 0.8 7.7 4.6 225.7

DOC(NIST) 24.5 8.5 22.7 20.9 15.3 5.7 12.8 110.4

NASA 1.2 9.8 7.7 0.2. 0.1 19.0

EPA 0.2 0.2 0.2 14.3 14.9

DHHS(NIOSH) 6.0 6.0

USDA(FS) 1.7 1.3 0.7 1.1 0.2 5.0

USDA(CSREES) 0.4 0.8 1.5 0.1 0.1 0.1 3.0

DOJ 2.0 2.0

DHS 1.0 1.0

DOT(FHWA) 0.9 0.9

TOTAL 550.8 227.2 327.0 81.5 62.1 161.3 76.4 40.7 1,527.0

FUN

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Source: National Nanotechnology Initiative, available at www.nano.gov

28

1. Include nanomaterials as new chemicals.

Add to section 3(2)(A) the following: “(iii) anymaterial produced in a form where one or moredimensions is less than 100 nanometers and wherephysical, chemical, or biological properties differsignificantly from similar materials with the samechemical identity due to its nanometer structure,even if such material has the same molecular iden-tity as a chemical already on the inventory, unless asubstantially identical nanomaterial is already onthe inventory.”

2. Allow EPA to obtain information to determinethe risk of new chemicals.

Delete section 5(e)(1)(A)(ii).

Delete section 5 (e)(1)(C).

3. Remove unrealistic constraints on EPA’s rule-making ability.

At the end of the first paragraph of section 6(a)delete “using the least burdensome requirements.”

Delete second paragraph of section 6(c)(1) (“Ifthe Administrator determines that a risk of injuryto health or the environment could be eliminated

or reduced to a sufficient extent by actions takenunder another Federal law … ”).

Delete section 9 (“Relationship to OtherFederal Laws”).

Modify the procedural requirements of sections6(c)(2) and (3).

Delete section 19 (c)(B) ( “substantial evidencein the rulemaking record”).

4. Modify the constraints imposed by the CBI pro-visions.

Add to section 14(a) a new paragraph: “(5) maybe disclosed to any state government, foreignnation, or international governmental organizationprovided that it has safeguards deemed by theAdministrator to be adequate for the protection ofthe information and subject to such other condi-tions as the Administrator may impose.”

Amend section 14 to require that informationlabeled CBI be accompanied by a certification,signed by a responsible official of the submittingfirm, that the confidentiality is necessary and justi-fiable and setting forth the specific and particularreasons for the confidentiality.

APPENDIX C: PROPOSED LEGISLATIVE CHANGES IN TSCA(Detailed conforming provisions are omitted.)

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

BOARD OF TRUSTEES

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

PUBLIC MEMBERS

James H. Billington, The Librarian of Congress; Bruce Cole, Chairman, National Endowment forthe Humanities; Michael O. Leavitt, The Secretary, U.S. Department of Health and HumanServices; Tami Longabergr, Designated Appointee within the Federal Government;Condoleezza Rice, The Secretary, U.S. Department of State; G. Wayne Claugh, The Secretary,Smithsonian Institution; Margaret Spellings, The Secretary, U.S. Department of Education; AllenWeinstein, Archivist of the United States

PRIVATE CITIZEN MEMBERS

Robin B. Cook, Donald E. Garcia, Bruce S. Gelb, Sander R. Gerber, Charles L. Glazer,Susan Hutchison, 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 $248 million in fiscal year 2007 to provide organ-izations and citizens with fact-based research and practical solutions for challenging issues.www.pewtrusts.org

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.

Project on EmergingNanotechnologies

Project on Emerging Nanotechnologies is supportedby THE PEW CHARITABLE TRUSTS

J. Clarence DaviesOne 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 EmergingNanotechnologies

PEN 13JULY 2008

AN AGENDA FOR THE NEW ADMINISTRATIONNANOTECHNOLOGY OVERSIGHT:

confidential business information

Comprehensive EnvironmentalResponse, Compensation,and Liability Act

Chronic Hazard Advisory Panel(under the Consumer ProductSafety Act)

Consumer Product Safety Commission

Dietary Supplement Healthand Education Act

environment, health and safety

Environmental Protection Agency

Food and Drug Administration

Federal Food, Drug, andCosmetic Act

Federal Insecticide, Rodenticide,and Fungicide Act

fiscal year

Interagency NanotechnologyRegulatory Group (proposed)

material safety data sheet(OSHA requirement)

non-governmental organization

National Institute of OccupationalSafety and Health

National Nanotechnology Initiative

National Science Foundation

Organization for EconomicCooperation and Development

Office of Management and Budget

Office of Research and Development(part of EPA)

Occupational Safetyand Health Administration

Office of Technology Assessment

Project on EmergingNanotechnologies, WoodrowWilson International Centerfor Scholars

Resource Conservationand Recovery Act

significant new use rule (under TSCA)

Toxics Release Inventory

Toxic Substances Control Act

CBICERCLA

CHAP

CPSCDSHEA

EHSEPAFDA

FFDCA

FIFRA

FYINREG

MSDS

NGONIOSH

NNINSF

OECD

OMBORD

OSHA

OTAPEN

RCRA

SNURTRI

TSCA

ACRONYMS