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									Project on Emerging
Nanotechnologies




creating an Effective Oversight System
for Nanotechnology
                                Mark Greenwood




     Project on Emerging Nanotechnologies is supported   Pen 7
          by The Pew ChariTable TrusTs                   March 2007
                                          cONtENtS
                                             About the Author 1

                                          Acknowledgements 1

                                                     Foreword 3

                                          Executive Summary 5

                                                   Introduction 7

                           The Need for Effective Oversight 9
                                                Why Now? 9
                        Designing a Product Oversight System 10

          The Building Blocks of a Product Oversight System 13

                                                   Risk Criteria   15
                           Living with “Regulation by Analogy”     16
                                          The Role of Exposure     17
                          Balancing Product Risks and Benefits     18

                                            Information Needs      20
                  The Reality of Significant Testing Obligations   20
                               When Is New Testing Needed?         21
                      Who Can Support Testing Obligations?         22
                                    What Products Are Viable?      23
                                 A Starting Point for Discussion   23

                                           Risk Management         25
              Aligning Risk Management with Product Life Cycle     25
Interplay Between Risk Management and Information Collection       26
                                         The Role of Labeling      27

                      Conclusion: The Issue of Transparency 28
                                                A Final Note 29
creating an Effective Oversight System
for Nanotechnology
                                                Mark Greenwood

                                                Pen 7 March 2007




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


About the Author
Mark Greenwood is a Partner in the Washington, D.C., office of Ropes & Gray,
where he practices environmental law. Regulatory issues affecting the develop-
ment and commercialization of new products are among his areas of special expertise.
Before joining Ropes & Gray in 1994, Mark worked for the U.S. Environmental Protection
Agency for over 16 years. He held a variety of senior positions in the Office of General
Counsel, managing legal issues in areas as diverse as pesticides, toxic chemicals, hazardous
waste management, Superfund, and environmental reporting. From 1990–1994, he was
Director of the EPA’s Office of Pollution Prevention and Toxics.




Acknowledgements
I would like to thank three reviewers of this report for their insights and practical advice: Jim
Willis, United States Environmental Protection Agency; Steve Harper, Intel Corporation;
and J. Clarence Davies, Senior Advisor to the Project on Emerging Nanotechnologies.
                                                                                                    


Foreword
Hundreds of nanotechnology-enabled products have already entered the market in areas ran-
ging from cosmetics to foods to sporting goods. The rate of commercialization is poised to acce-
lerate, with products increasing in both number and diversity across multiple industrial sectors.
However, the oversight system for nanotechnologies is immature. Given the novel behavior and
properties of nanoscale materials, it is not obvious whether, or to what extent, existing regu-
lations might apply. To date, discussions about nanotechnology oversight have focused on the
adequacy of specific statutes, such as the Toxic Substances Control Act (TSCA) administered
by the Environmental Protection Agency (EPA). There has been far less discussion about the
adequacy of the analytical assumptions and approaches underlying our environmental statutes in
general. For instance, will core assumptions about risk assessment and risk management translate
from a macro to a nano world? Because nanotechnology is already here, and both workers and
consumers may already be exposed to risks, we cannot afford to “wait and see.”
    This report looks broadly at a variety of regulatory approaches for products and facili-
ties and examines the analytic methodologies—such as emissions monitoring or the use of
analogies and structure activity relationships to predict risks—that underpin these regula-
tions. In most cases, the report uses EPA and its regulations as a basis for discussion. In every
case, nanoscale materials will likely challenge the existing approaches, potentially render-
ing them inoperative or, at best, sub-optimal.
    As an alternative, the report suggests that a number of statute-independent questions
need to be addressed and answered by government, industry, non-governmental organiza-
tions (NGOs), and other key stakeholders. These questions involve:

- Risk criteria (what is and is not a problem?);
- Information needs (what do we need to know to support decision-making?); and
- Risk management measures (what tools should be used to manage risk?).

Solving issues in these areas, rather than relying strictly on specific statutes, will be key to
effective nanotechnology oversight. In addition, a serious discussion of these core elements
of an oversight system is likely to increase industry engagement and provide better guidance
to technology developers that operate on the cutting edge of the science.
   There is much at stake. How the oversight system evolves at this early stage will have sig-
nificant impacts on industry structure, the competitive strategies of firms, and approaches
to intellectual property. It can ultimately define who can “play” or not, especially if the
costs of testing and data submissions are high. These impacts have not received the attention
they deserve but need to be addressed as soon as possible.

   David Rejeski
   Director, Project on Emerging Nanotechnologies
   Woodrow Wilson International Center for Scholars
                                                                                                


Executive Summary
As nanotechnology becomes more and more a commercial reality, concerns about the ade-
quacy of current oversight tools have increased and discussions of possible new oversight
methods have begun. This report looks at oversight as encompassing a wide range of me-
chanisms and institutions that will be involved in protecting human health and the envi-
ronment. The purpose of this report is to focus greater public attention on three sets of
issues that will necessarily define the framework of an effective oversight system for nanos-
cale materials, regardless of the agency or regulatory statute:

•	 Risk criteria (what is and is not a problem?);
•	 Information needs (what do we need to know to support decision-making?); and
•	 Risk management measures (what tools should be used to manage risk?).

    Current public discussions about the emerging oversight system have not given adequate
attention to these topics but, instead, have tended to focus on specific laws and statutes.
Essentially, we have let the laws set the boundaries of our discussion, rather than explor-
ing a wider set of questions that need to be answered if society is to adequately address any
potential risks from nanotechnologies.
    The report begins by examining the issues that arise when present approaches to risk
characterization, including the use of analogies and structure activity models, are applied
to nanotechnology. These approaches assume that our existing knowledge of chemical
behavior is a fairly good predictor of the future, an assumption that may be undermined
by the emergence of novel properties at the nanoscale. Determining the nature and extent
of exposure will also be problematic, especially across the entire life cycle of nanotech-
nology-based products.
    Attempts to characterize risks will lead to the development of information needs. These
are likely to be the subject of some of the first major debates around the appropriate lev-
els of oversight. The amount of information needed to understand the risks and exposure
routes of nanomaterials is likely to be more extensive, and expensive, than what is currently
expected for conventional chemicals. New testing may be needed. This will raise real is-
sues about who can support testing obligations and whether these obligations will become
barriers to innovation or significant hurdles for small businesses. In the end, information
requirements and associated testing may ultimately determine what products will be viable
and what businesses will succeed.
    As companies and government approach the larger issues around risk management, the
limitations of existing laws become more apparent. Existing product-based regulations have
difficulty addressing issues related to environmental releases of materials during use and
waste management scenarios that will arise with products at the end of their life cycles.
An oversight system is needed that will function across the entire life cycle, managing
risks where the need is greatest. One part of this system may include the use of labels for


    nanoscale materials—an issue that is likely to be contentious—as will other measures de-
    signed to increase transparency through the public disclosure of information.
       Given the flow of new nanotechnology-based products into the marketplace, we can-
    not defer discussions about risk criteria, information needs and risk management measures.
    Oversight decisions are being made today, and companies are already having discussions
    about guidelines to protect workers from potential exposures. The evolving requirements
    of any oversight system will have long-term impacts on business models that can be success-
    ful in the development of nanotechnology. The purpose of this report is to force the discus-
    sion of nanotechnology oversight outside of the confines of existing laws and statutes in the
    hope that more innovative solutions can be found that both foster innovation and protect
    humans and the environment.
                                                     Thinking Big About Things Small              


Introduction
Nanotechnology is no longer the stuff of dreams. It has become an important technological
driver of innovation in today’s economy. With this emerging role, nanotechnology poses an
inevitable question: How can we make sure that it will be used safely?
   The public discussion of this question has already begun. A wide spectrum of interests in
the United States seems to agree that some form of oversight system is needed to assure that
nanotechnology develops without adverse effects on health, safety and the environment.
Many groups recognize the potential societal benefits of nanotechnology, from a variety of
perspectives. At the same time, there also seems to be a common understanding that some
nanoscale materials will have hazardous properties that need to be identified and managed.
While the specifics of how to manage these risks has spawned many debates and the politi-
cal process for improving the oversight system has begun, much of the rhetorical excess that
has haunted the development of biotechnology has so far been avoided.
   This support for some form of oversight system anticipates that a set of institutions will
need to assure that common terms, best practices, testing obligations and public account-
ability will be established. Certainly government regulation will play a key role in the over-
sight system, but it is both unnecessary and impractical to leave the oversight role entirely
to a limited set of already overburdened federal agencies. Nanotechnology is moving too
quickly for such a strategy. Instead, a variety of consensus standards, codes and understand-
ings, both domestic and international, are likely to play key roles in the oversight system for
nanotechnology.
   Thus, when using the term “oversight system,” this report intends to include the full
range of institutions and mechanisms that could be involved in the protection of health,
safety and the environment. While examples will be drawn primarily from the experience
of government, the intent of this report is to identify the issues that need attention, rather
than to address questions about what institutions should set policy.
   The purpose of this report is to focus greater public attention on three sets of issues that
will necessarily define the framework of an oversight system for nanoscale materials:

•	 Risk criteria (what is and is not a problem?);
•	 Information needs (what do we need to know to support decision-making?); and
•	 Risk management measures (what tools should be used to manage risk?).

Current public discussions about the emerging oversight system have not given adequate
attention to these topics.
   A variety of well-intentioned, cooperative efforts are currently addressing questions that
are important, but somewhat narrow. For example, the U.S. Environmental Protection
Agency (EPA) has been grappling with questions about the jurisdiction of the Toxic
Substances Control Act (TSCA) over nanotechnology, and the agency has begun exploring
a voluntary program to obtain information on existing nanotechnology substances in the


    marketplace. Clearly, EPA is trying to deter-                Under these circumstances, an incremen-
    mine how to “get started” on what will be                tal approach to creating a reasonable oversight
    a long, complex endeavor and thus is under-              system is not a prudent strategy. It is time for
    taking what appear to be manageable steps.               government, industry, the scientific com-
    While such an approach is understandable,                munity, non-governmental organizations
    is it a strategy that meets the challenges of            (NGOs) and other interested parties to begin a
    nanotechnology?                                          more systematic discussion about the core ele-
        Commercialization of nanotechnology                  ments of an oversight framework for nanoscale
    is moving very quickly. A recent inventory               materials, both those already on the market
    of nanotechnology-enabled consumer prod-                 and those that are likely to follow in the near
    ucts has identified over 380 products already            future. This should include substantive debate
    in commerce from 17 countries.1 Another                  about the three topics—risk criteria, informa-
    study has indicated that the number of nan-              tion needs and risk management measures—
    otechnology-enabled drugs and biomedi-                   addressed by this report. Greater understand-
    cal devices in the pipeline for regulation               ing—and, hopefully, consensus—about the
    has increased by almost 70 percent in just               general design of an improve oversight system
    one year.2,3 A new inventory just released in            will provide a context and a sense of direction
    Japan has identified over 260 products in the            for all parties who are working toward com-
    marketplace, including over 90 cosmetics                 mon goals, while recognizing that there may
    and over 15 food products.4                              be several paths to the same endpoint.

    1. See Inventory of Nanotechnology Consumer Products, Washington, DC: Project on Emerging
       Nanotechnologies, Woodrow Wilson International Center for Scholars, 2006, available at http://www.
       nanotechproject.org/consumerproducts, accessed January 3, 2007.
    2. 2006 Nanomedicine, Device & Diagnostics Report. Atlanta, GA: NanoBiotech News, National Health
       Information, LLC, 2006.
    3. A list of nano-based medical products already available on the market, including drugs, drug delivery devices
       and diagnostic tests, can be found at Nanotechnology and Medicine Inventory, Washington, DC: Project on
       Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, October 2006, available
       at http://www.nanotechproject.org/86, accessed January 3, 2007.
    4. This online inventory can by found at http://staff.aist.go.jp/kishimoto-atsuo/nano/index.htm and in a
       translated version at http://translate.google.com/translate?u=http%3A%2F%2Fstaff.aist.go.jp%2Fkishimoto-
       atsuo%2Fnano%2Findex.htm&langpair=ja%7Cen&hl=en&safe=off&ie=UTF-8&oe=UTF-
       8&prev=%2Flanguage_tools, accessed January 3, 2007.
                                                               Thinking Big About Things Small                       

the need for effective oversight
Why Now?                                                      initially guide nanotechnology oversight
Certainly some will argue that the core is-                   would facilitate consensus on a roadmap
sues identified in this report are complex                    for research priorities. In 2005, EPA so-
and will benefit from more information and                    licited comment on its Nanotechnology
experience. In a slower-moving context,                       White Paper, which discusses the agency’s
such a strategy would make sense. It is a                     research needs related to nanotechno-
mistake, however, to defer discussion about                   logy.5 While the document is a serious
the risk criteria, information needs and risk                 look at the range of issues that can arise
management measures that will underpin                        with nanotechnology, it is less successful
an effective oversight system for nanotech-                   as a practical statement of priorities about
nology for the following reasons:                             nanotechnology research, given EPA’s li-
                                                              mited budget for such work.6
   O
•	 	 versight decisions are being made
   today. Government agencies are already                    A
                                                          •	 	 serious discussion of the core ele-
   conducting reviews of new nanoscale                       ments of an oversight system is likely
   materials. In doing so, they are taking                   to increase industry engagement. Many
   positions in all three of the key areas.                  of the innovators in this field are small
   What is missing is a public discussion of                 companies that often lack the human
   these positions.                                          and financial resources to participate in
                                                             pilot programs or other initiatives that
•	 	 n industry, groups of leading companies
   I                                                         seem preliminary. Some of these firms
   are beginning to discuss guidelines about                 do not have highly developed product
   how to protect workers potentially expo-                  stewardship systems for addressing the
   sed to nanoscale materials. As they do so,                health and environmental implications
   they will inevitably be reaching conclu-                  of their products. Such firms are much
   sions in each of the three areas.                         more likely to step forward to participate
                                                             in a discussion that addresses core requi-
•	 	 better understanding of the risk cri-
   A                                                         rements about the risk criteria, informa-
   teria and information needs that will                     tion requirements and risk management

5. External Review Draft Nanotechnology White Paper. Washington, DC: Environmental Protection Agency,
   December 2, 2005, available at www.epa.gov/osa/pdfs/EPA_nanotechnology_white_paper_external_re-
   view_draft_12-02-2005.pdf, accessed January 3, 2007 (“EPA White Paper”).
6. In September 2006, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the
   Committee on Technology, National Science and Technology Council issued a similar strategy document,
   entitled Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials. This document is
   more successful as a summary of research that has, and could be, conducted than as a pragmatic action plan.
   Both the EPA and NSET documents serve as a reminder that the United States Government is under-fun-
   ding its overall research program on the health and safety aspects of nanotechnology. As indicated in a recent
   report by Dr. Andrew Maynard of the Woodrow Wilson International Center for Scholars, Nanotechnology: A
   Research Strategy for Addressing Risk, the U.S. Government’s investment in such research is quite small. In the
   long run it is critical to increase the scope and pace of health and environmental research on nanomaterials so
   the results are available to inform oversight decisions as well as help in communicating to the public.
0

        measures that will define what actions                  Designing a Product
        they should take to manage nanotech-                    Oversight System
        nology safely if they are engaged early                 Current discussions in the United States
        in the oversight process.                               about health and safety protections rela-
                                                                ted to nanotechnology tend to assume that
     •	 	 substantive discussion about the core
        A                                                       oversight should focus on products contai-
        policies of an oversight system would                   ning nanoscale materials.7 Such a perspec-
        also provide important guidance to te-                  tive is notable because the most developed
        chnology developers that operate at the                 environmental regulatory programs in the
        cutting edge of the science. In fast-mo-                United States focus not on products but on
        ving industries, where technologists are                facility emissions and management.8
        exploring many options in short time                        While there is a need for a broader dialogue
        frames, innovators will respond to even                 about how the full range of environmental
        weak signals from governments and                       statutes should address developments in nano-
        other standard setters about potential                  technology, it is reasonable to focus initially on
        problem areas. They will look for op-                   products containing nanoscale materials, while
        tions that appear to minimize potential                 keeping in mind that facilities and related
        concerns about health and safety while                  production processes must also be addressed
        maintaining performance at reasonable                   as the establishment of the regulatory system
        costs. It is time to start the discussions of           progresses.9 In focusing on product oversight,
        the core policies of an oversight system                however, it will be important to address oc-
        so that clear signals can be sent to these              cupational risks, both in commercial-scale op-
        technology innovators.                                  erations and in the laboratory, where human
                                                                exposure to nanoscale materials is likely to be
     •	 	 he requirements of an oversight system,
        T                                                       greatest. As will be discussed below, product
        especially those related to information                 oversight systems have historically been well-
        generation, will have long-term effects                 suited to addressing workplace risks.
        on the evolution of the business models                     In considering what form of oversight
        that can be successful in the development               system makes sense for products containing
        of nanotechnology.                                      nanoscale materials, it is useful to recognize


     7. See J. Clarence Davies, Managing the Effects of Nanotechnology, Washington, DC: Project on Emerging
        Nanotechnologies, Woodrow Wilson International Center for Scholars, January 2006, available at http://
        www.nanotechproject.org/file_download/30, accessed January 3, 2007, p. 14; EPA White Paper, supra note
        5, p. 24.
     8. The EPA’s budget is dominated by programs established under the Clean Air Act, Clean Water Act, Safe
        Drinking Water Act, Resource Conservation and Recovery Act and Comprehensive Environmental
        Response, Compensation and Liability Act to prevent and clean up pollution at specific facilities or sites.
     9. There are several reasons to look at a broader range of programs as part of an oversight system for nanotech-
        nology, but two factors are particularly important. Product regulatory programs have inherent difficulties
        setting management practices for downstream activities, such as disposal operations. It is difficult for a pro-
        duct oversight system to predict how such residuals will arise and be managed and to employ typical product
        management tools (e.g., product labels) to set clear standards. In addition, at least in the United States, the
        federal programs for product oversight tend to operate with much smaller resource bases than the more
        extensive environmental regulatory programs that oversee facility management.
                                                     Thinking Big About Things Small                

that regulatory systems for products in the          If the agency raises no objection in the
United States have historically followed one     fixed time period, the product may proceed to
of three general patterns:                       commerce. The agency may provide a written
                                                 recognition that the product can proceed with
1. Product-specific Approvals                    its intended use, although this recognition is
Under this approach, manufacturers or mar-       sometimes characterized as an “acceptance,”
keters of products submit information about      rather than an “approval,” of the product.
their products to an oversight agency and        Alternatively, the agency may raise objections
receive licenses to introduce, distribute and    to the product, which typically leads to some
market their products in commerce. Typically     form of restriction or to additional data sub-
the advocate for the license carries a burden    mission requirements. When an agency raises
to demonstrate the safety—and, in some           objections to a product during the screening
cases, the efficacy—of the product for the       stage, it may take formal action (e.g., adminis-
claimed benefits used in advertising and labe-   trative order) to impose requirements or direct
ling. The informational requirements faced       a submitter to seek a more formal approval, as
by applicants for a license under this type of   described above.
program are often rather substantial, making         The federal regulatory program that
the license difficult to obtain and highly va-   perhaps best characterizes this model is the
luable in the marketplace once granted.          pre-manufacture review program for new
    This model is followed most directly by      chemicals under TSCA. FDA also employs
the U.S. Food and Drug Administration            a similar approach in its “510(k)” reviews
(FDA) in its regulation of drugs and certain     of medical devices claimed to be similar to
medical devices. At EPA, this model reflects     existing products and for drugs manufac-
the design of the pesticide program under        tured consistent with U.S. Pharmacopeia
the Federal Insecticide, Fungicide and           monographs.
Rodenticide Act (FIFRA). EPA’s program
under the Clean Air Act (CAA) for the reg-       3. regulation by government initiative
istration and regulation of fuels and fuel ad-   For other classes of materials, agencies
ditives also resembles this model.               screen available information about products
                                                 and initiate investigations or more formal
2. Product-specific screening                    regulatory action if they become aware
In this model, the manufacturer or marke-        of an issue of significant concern. In this
ter of a product provides basic information      model, manufacturers do not provide pro-
about a product to an oversight agency,          duct-specific information to agencies unless
usually within some fixed time frame, be-        asked. Generally, agencies carry the burden
fore the product is intended to enter com-       of proof to demonstrate that a product pre-
merce. During this “review period,” the          sents an unreasonable risk. Agencies typica-
agency must decide whether it has any con-       lly use general rulemaking authority to im-
cerns about the product, based on its inten-     pose controls in this situation.
ded use, the information supplied by the             This model defines the authority and ap-
product manufacturer and other informa-          proach of the federal government in a wide
tion available to the agency.                    range of areas. EPA’s TSCA authority over
2

     existing chemicals in commerce follows                determine agency jurisdiction and the de-
     this model, as does the Consumer Product              gree of oversight that a product faces.
     Safety Commission (CPSC). Likewise,                      To be certain, the applicability of exist-
     FDA employs this approach for food ad-                ing regulatory programs will dictate many
     ditives and food packaging “generally                 of the risk criteria, information require-
     recognized as safe” (GRAS), as well as for            ments and management practices that will
     cosmetics.                                            apply to specific products. Agencies will
        At least at this time, the “Regulation by          want to adhere to their current policies and
     Government Initiative” model described                practices to the extent possible. At the same
     above is probably the prevailing model for            time, nanoscale materials present challenges
     oversight of nanoscale materials now in com-          for all the current regulatory programs, rais-
     merce, although this profile may change in            ing new issues that reveal gaps in existing
     the future.10 While some have suggested that          policies, data and assessment methodologies.
     Congress should consider the development              Moreover, these regulatory programs are
     of a new statute to regulate nanotechnology,          likely to be influenced by the other non-
     such legislation does not seem imminent.11            regulatory elements (e.g., voluntary stan-
     Assuming that the current statutory and               dards) of the emerging oversight system for
     regulatory system remains in place, we must           nanotechnology.
     assume that the evolving oversight system                Therefore, it is important in all these con-
     for nanoscale materials will reflect a mix of         texts that interested parties begin discussing in
     the three approaches described above. A se-           a more systematic way the risk criteria, infor-
     ries of definitional issues (e.g., is a material a    mation needs and risk management practices
     new or existing chemical?) and use patterns           that should be guiding the oversight system
     (e.g., is a material a drug or a cosmetic?) will      for products containing nanoscale materials.

     10. For a compendium of consumer products containing nanoscale materials, see Inventory of Nanotechnology
         Consumer Products, supra note 1.
     11. See Davies, supra note 7, p. 18.
                                                             Thinking Big About Things Small                    

the building blocks of a
Product oversight system
As indicated above, an effective and trans-             fully distinct in an effective oversight sys-
parent product oversight system will neces-             tem. They are intertwined: one set of poli-
sarily be built upon three sets of policies:            cies is often nested within the policies in
                                                        one of the other areas. The risk criteria, for
• Risk Criteria—What health, safety and                 example, define the areas where informa-
  environmental effects of a material cons-             tion will be needed. Data submissions may
  titute a problem, including the identifi-             also trigger additional risk criteria, which
  cation of appropriate surrogates for gau-             will then trigger additional data needs. Risk
  ging such effects? How much risk from                 management measures obviously follow di-
  the material does the system view as ac-              rectly from risk criteria. At the same time,
  ceptable, perhaps considering the benefits            the willingness to adopt certain risk man-
  of the product?                                       agement measures may eliminate the need
                                                        to explore certain risk issues or to collect
• Information Needs—What information                    certain data. Often, certain risk manage-
  is needed to determine whether a pro-                 ment measures are seen as alternatives to
  duct is acceptable under the risk criteria            data collection obligations.
  guiding decisions? What further data is                  Those who are familiar with the work-
  needed to confirm or rebut assumptions                ings of the new chemical program under
  being made about the product’s effects?               TSCA will recognize that EPA’s policies
                                                        under that program reflect these three
• Risk Management Measures—What set of                  building blocks. Yet this observation does
  product specifications, handling prac-                not suggest that the TSCA statutory frame-
  tices, disclosures and use limits are ne-             work is necessarily the preferred frame-
  cessary to assure that risks from the pro-            work for product oversight. In fact, the
  duct remain in an acceptable range? Or,               TSCA statute did not address any of these
  should risk management be addressed by                topics in a systematic way.12 Instead, EPA
  a general exposure standard accompa-                  has set the core TSCA policies on risk cri-
  nied by a monitoring program based on                 teria, information needs and risk manage-
  approved protocols?                                   ment measures on an incremental basis over
                                                        several decades. The issues EPA addressed
   While this report will examine each                  in developing that program were universal
of these policy areas separately in the next            questions that all product oversight pro-
three sections, these policy areas will not be          grams must face.

12. The TSCA statute, which was passed in 1976 and has remained essentially unchanged, defined the jurisdic-
    tion of the program (i.e., pre-manufacture review of new chemicals), created a few exemptions, put limits
    on the data EPA could require in an initial pre-manufacture notice and specified the time frame in which
    EPA had to make a judgment on individual new chemicals. EPA was left with the task of defining the subs-
    tantive policies that would guide the program.
4

        The oversight system’s approach to risk   needed? The time to begin public discus-
     criteria, information needs and risk man-    sion of these broader questions and guiding
     agement measures will shape the overall      policies is now.
     social and economic trajectory of nano-          In the following sections, challenges as-
     technology. What categories of nanoscale     sociated with addressing risk criteria, infor-
     materials represent the most promising       mation needs and risk management practices
     commercial products? What kinds of com-      issues in the development of an effective
     panies can face the rigors of commer-        oversight system for nanoscale materials will
     cial development? What research is most      be identified and analyzed.
                                                                 Thinking Big About Things Small                      

risk criteria
Oversight systems for nanoscale materials                  such as active nanostructures capable of
will try, to the extent possible, to build                 changing their properties during use, and
upon the policies that have guided the re-                 systems of nanostructures, the approaches
view of conventional chemical substances.                  to toxicological testing will need to evolve.
This reflects a natural tendency to stay with              Similarly, the likely convergence of nano-
the familiar way of doing business. Such an                technology and biology will pose special
approach for nanotechnology, however, is a                 challenges.
rational starting point and is the one taken                   While pre-existing toxicity information
by governments in both the United States                   on the “macroscale” version of a chemical
and Europe.                                                is relevant to evaluating a nanoscale ver-
    In the sweep of hype and euphoria about                sion of the same chemical, the challenge is
nanotechnology, it is important to recog-                  that such information is probably not suf-
nize that many of today’s nanomaterials are                ficient for effective oversight. Much of the
variations on existing materials. The basic                appeal of nanoscience is that it allows ma-
chemistry of a nanoscale material usually                  terials scientists to create novel properties
remains the same as that of its “macroscale”               and functions at the nanoscale level that
predecessor, though its physical structure                 are not achievable outside the nanometer
may vary significantly, thereby changing                   domain. A nanotechnology oversight sys-
its risk characteristics. The existing toxicity            tem must develop a perspective on whether
profile of the bulk material is a logical start-           these novel properties and functions are as-
ing point in any review of a nanoscale mate-               sociated with adverse health and environ-
rial, but it is only a starting point.                     mental effects. Once developed, that per-
    Nanotechnology is unlikely to require                  spective necessarily establishes the default
a whole new framework for basic toxicol-                   assumptions that define the contours of the
ogy. Several regulatory agencies and scien-                oversight system’s risk criteria.
tific groups that have begun to look at the                    It will be argued that this challenge is less
scientific challenges presented by nanotech-               critical for the formal “product approval”
nology have concluded that the range of                    programs identified earlier, such as the FDA
currently available toxicity tests provides a              drug approval and EPA pesticide registra-
logical place to begin to assess the potential             tion programs. This viewpoint reflects the
risks of nanoscale materials.13                            fact that products covered by these programs
    This assumption will be challenged over                tend to require significant amounts of tox-
time as nanotechnology matures. As com-                    icity testing and product characterization
panies move from use of first-generation                   prior to their approval and introduction into
nanoscale materials (e.g., simple “passive”                the marketplace. There is some merit to this
nanoparticles) to more complex structures,                 argument. The broad batteries of tests used

13. See Developing Experimental Approaches for the Evaluation of Toxicological Interactions of Nanoscale Materials,
    Gainesville, FL: National Toxicology Program, November 3-4, 2004, p. 6; Nakissa Sadrieh, Ph.D.
    “Considerations for Regulation of Nanomaterial Containing Products,” January 2006, slide 33, available at
    http://www.fda.gov/nanotechnology/NIST_meeting_houston_01-06.ppt, accessed January 4, 2007.


     in these programs may well identify differ-              nanoscale materials. It is not, however, cur-
     ences in toxicity associated with nanoscale              rently capable of addressing toxicity that
     versions of existing chemical substances.                may be associated with the novel properties
        Yet, even in the product approval over-               and behaviors of a nanoscale material. Given
     sight model, there will be some gaps in the              the dynamic nature of nanotechnology de-
     scope of needed testing that can be addressed            velopment, it is unlikely that the technol-
     only after the oversight system defines the              ogy will remain “stable” long enough for
     linkages between novel nanoscale attributes              the iterative, and painstaking, process that
     and adverse health or environmental effects.             led to the SAR framework for conventional
     Moreover, oversight bodies will struggle,                chemicals to generate a comparable frame-
     under any of the three models described                  work for nanoscale materials. By the time
     above, to understand how nanomaterials                   EPA might be able to develop a SAR ap-
     migrate in the environment and how expo-                 proach for the more prevalent nanostruc-
     sure might vary over their life cycles.                  tures of today (e.g., carbon nanotubes), the
                                                              cutting edge of new products may have
     Living with “Regulation                                  switched to nanostructures integrated with
     by Analogy”                                              biological materials, guided assemblies and
     All product oversight systems rely, to a grea-           other innovations for which the SAR model
     ter or lesser extent, on analogies to other              becomes obsolete.
     materials. Under the current version of the                  While a routinized approach such as
     TSCA program, for example, EPA relies                    SAR may not be viable for nanotechnology,
     on what it calls “structure activity relatio-            the basic premise of SAR—using analogies
     nships” (SAR) to evaluate the health and                 to assess the risks of nanomaterials—is in-
     environmental effects of new substances. In              evitable. As will be discussed in the next
     essence, EPA has built up a body of data and             section, the developing oversight system
     insights about the likely toxicity associated            is likely to expect greater levels of data for
     with certain chemical structures that are                nanoscale materials than has been expected
     commonly found in many materials. On the                 for existing chemicals. At the same time,
     basis of this SAR analysis, EPA reviews a set            it is neither reasonable nor politically re-
     of basic information about the chemical and              alistic to expect that industry will develop
     physical characteristics of a new chemical               an exhaustive set of toxicity and exposure
     and reaches a judgment about its likely toxi-            testing data for every material for every ap-
     city. This judgment then guides the agency’s             plication. Some form of “tiered” testing
     approach to testing and risk management.14               is more likely to emerge, and that tiered
        EPA has developed the SAR approach                    system will be guided by risk criteria that
     over several decades. It is a starting point             are based on what is known about exist-
     for evaluating any substance, including                  ing nanomaterials and related chemicals.

     14. On the basis of this analytic framework, EPA has developed and made publicly available a manual defining
         “Categories of Concern,” which explains in some detail the agency’s general approach to certain classes of
         chemicals, particularly in regard to testing obligations. See generally, Miriam Wiggins-Lewis, J. Vincent
         Nabholz, and Rebecca Jones, TSCA New Chemicals Program (NCP) Chemical Categories, Washington, DC:
         Environmental Protection Agency, October 2002, available at www.epa.gov/opptintr/newchems/pubs/
         cat02.pdf, accessed January 3, 2007 (“Categories of Concern”).
                                                       Thinking Big About Things Small               

Accordingly, oversight bodies will build              How EPA might apply those analogies,
their policies concerning particular prod-         or similar analogies it constructs for na-
ucts around analogies that they draw be-           noscale materials, will have profound effects
tween new nanoscale materials and other            on innovation, products and businesses.
materials about which more is known.               Such analogies may determine whether the
    An important, and very timely, example         product is allowed in certain uses and will
of this issue concerns the analogies that gov-     certainly determine occupational controls,
ernment agencies will use to review nanopar-       labeling and other notification require-
ticles. Suppose, for example, EPA were to de-      ments at a manufacturing site. Significantly,
fine the risks of nanoparticles by drawing an      the analogy also defines the testing that a
analogy to the agency’s approach to particu-       product developer must meet if it wants to
lates under the CAA. In that context, EPA          overcome a presumption that a product will
has defined particulates smaller than 2.5 mi-      cause an effect of concern.
crons as per se pollutants and has developed
elaborate air pollution control strategies to      The Role of Exposure
eliminate emissions of such particles. Under       A particularly important aspect of the risk
that definition, all nanoscale particles (pre-     criteria for nanoscale materials, regardless of
sumed to be below 100 nanometers) would            the oversight mechanism used, is how those
be deemed detrimental to public health. It         risk criteria address questions of exposure.
seems unlikely that nanotechnology would           There certainly will be situations where a
prosper under such a policy.                       combination of factors greatly reduces the
    While such a policy is probably too dra-       potential for exposure. Thus, a set of risk
conian to consider as a guide to oversight of      criteria that focused only on the potential
engineered nanomaterials, there are other          hazard of a chemical structure would not be
versions of this same question that would          reflective of reality.
have significant impact. For example, in               A critical issue to define in considering
evaluating many inorganic materials submit-        exposure is whether the oversight system
ted under the TSCA new chemical program,           will focus on the nanoscale material itself,
EPA evaluates whether the substance will           on the larger product in which it is commer-
generate respirable particles. If so, EPA then     cialized or on the fate of the product after
determines whether the material is analogous       its use. Existing regulatory systems tend to
to one of several substances, including crys-      look at all these questions to some degree,
talline silica, talc, titanium dioxide or carbon   but the nature of nanoscale materials proba-
black. If the analogy is drawn to crystalline      bly warrants a closer look at the commercial
silica, the substance is assumed to be quite       product throughout its life cycle.
toxic and is presumed to be a human car-               Many nanoscale materials are compo-
cinogen. If the analogy is drawn to titanium       nents of a larger matrix of materials. This
oxide, the substance faces a much more be-         occurs because nanoscale materials are often
nign presumption and the data on cancer is         being used in small amounts to add a par-
presumed to be “inadequate” to classify the        ticular characteristic (e.g., the ability to
material as a human carcinogen.15                  conduct electricity) to an existing material.

15. Ibid., p. 118.


     In addition, some nanoscale materials may                and then reach an overall conclusion. This is
     have characteristics (e.g., the potential to             certainly the case in oversight systems such
     agglomerate and lose performance) that                   as the FDA drug approval program, which
     dictate the use of coatings that are essential           looks at efficacy (e.g., assuring that approved
     parts of the product as used. In other situa-            medicines perform as claimed) as well as
     tions, such coatings may be used to address              safety concerns (e.g., determining whether
     directly a particular characteristic that might          the side effects of a medicine undermine its
     raise health concerns (e.g., a physical shape            value as a cure).
     analogous to that of asbestos fibers).                      Additionally, the same logic operates, per-
         This question of what form of the na-                haps less obviously, in product oversight systems
     noscale material to evaluate will probably               that do not explicitly evaluate product claims
     generate some debate. Some people will                   from a consumer protection perspective. EPA’s
     argue that the “matrixed” nature of many na-             pesticide and TSCA oversight programs eval-
     noscale materials at the use stage of their life         uate products against an “unreasonable risk”
     cycles should reduce the potential exposure              standard that allows for consideration of the
     and risk of the material.16 Others will argue            economic, social and environmental costs—as
     that the breakdown of coating materials dur-             well as the benefits—of a product.
     ing the latter stages of a product’s life cycle or          Assuming that the risk criteria for na-
     through metabolism in the body necessitates              noscale materials will inevitably involve
     a focus on the nanoscale material itself.                some balancing of the advantages and dis-
                                                              advantages of individual products, public
     Balancing Product                                        consideration of this issue is warranted. This
     Risks and Benefits                                       discussion need not devolve into a replay of
     Another critical issue that needs to be                  old debates about the merits of cost-benefit
     discussed in defining the risk criteria for              analysis. Part of the discussion should cer-
     nanoscale materials is social trade-offs.                tainly involve consideration of scenarios
     For product oversight systems, the need                  where the risks of a technology cannot be
     to weigh the basic advantages and disad-                 overcome by any putative benefits. At the
     vantages of a product is a well-established              same time, it would be useful to define
     principle. This stands somewhat in contrast              some categories of benefits (e.g., pollution
     to regulatory debates over environmental                 prevention, enhancements of public health,
     standards for facilities, where the appro-               environmental cleanup, energy and resource
     priate use of cost-benefit analysis remains              conservation) that draw broad public sup-
     controversial.                                           port and that justify development of prod-
        In the context of product regulation,                 ucts that carry real, but manageable, risk.
     oversight systems consider a range of posi-                 The need to consider social trade-offs un-
     tive and negative attributes about a product             derscores a broader point about all aspects of

     16. This perspective can lead to a focus on oversight of “free” nanoparticles that are separate from nanoma-
         terials contained in a larger matrix. A recent proposal for a voluntary reporting program in the United
         Kingdom asks participants to report only on “free” nanomaterials. See Consultation on a Proposed Voluntary
         Reporting Scheme for Engineered Nanoscale Materials, London, UK: Department for Environment, Food and
         Rural Affairs, March 2006, available at http://www.defra.gov.uk/corporate/consult/nanotech-vrs/consul-
         tation.pdf, accessed January 3, 2007, p. 16.
                                                     Thinking Big About Things Small              

the risk criteria. Even though the operational   in order to see it prosper. When values are
aspects of these criteria may appear highly      involved, there always will, and should, be
technical and scientific, they are ultimately    some debate. Hopefully, regulatory agencies
value statements. Risk criteria will define      will take advantage of the apparent opportu-
how we value the benefits of nanotechnology      nity to have a more thoughtful, less polarized
and what social risks we are willing to take     discussion of these issues.
20

     information needs
     While risk criteria constitute the soul of a              Knowing the unique characteristics of a
     product oversight system, information re-                 nanoscale version of a chemical or material
     quirements that the system imposes define                 will help scientists understand the proper-
     its initial profile. Accordingly, the informa-            ties that are most likely to be associated with
     tion requirements are likely to be the sub-               toxic effects. Such information facilitates
     ject for some of the first major debates about            the development of control strategies for
     the appropriate level of oversight.                       that particular substance. In addition, such
                                                               information increases the overall body of
     The Reality of Significant                                information about the relationship between
     Testing Obligations                                       the characteristics of nanoscale materials
     For several reasons, the information requi-               and toxicity. Over time, these insights may
     rements for nanoscale materials are likely to             allow the oversight system to develop more
     be more extensive than those currently ex-                targeted information needs.
     pected for conventional forms of the same                     Collecting needed information is likely
     materials. Due to their size and novel pro-               to be costly, particularly in the early years
     perties, nanomaterials have much greater                  of an oversight system. As indicated above,
     potential to move throughout the body than                the range of needed information will prob-
     larger particles do. This potential understan-            ably be extensive. In addition, material test-
     dably leads to greater concern about a range              ing will be more difficult to perform at the
     of health effects. For example, with respect              nanoscale. For example, generating pure
     to inhalation of larger particles, regulatory             samples of nanoscale materials and admin-
     agencies have tended to focus on poten-                   istering doses to test animals in a manner
     tial toxic effects in the respiratory system.             that simulates realistic conditions is likely to
     Emerging data on nanomaterials, however,                  require special care and skills in the labora-
     suggest that they are able to cross cellular              tory. It will take some time before a wide
     barriers and migrate to multiple organ sys-               range of laboratories, including the contract
     tems, including the brain.17 This potential,              laboratories upon which smaller companies
     therefore, indicates the need for toxicity tes-           must rely, have that capability.
     ting that examines multiple organ systems                     Until testing at the nanoscale becomes
     and disease endpoints.                                    more routine, product developers will face
         Scientists also recommend that testing re-            premium prices for toxicity tests on na-
     gimes for nanoscale materials should include              noscale materials. These costs will be partic-
     a thorough characterization of the materi-                ularly onerous for small- and medium-size
     als’ physical and chemical characteristics.18             enterprises. Thought needs to be given to

     17. Gunter Oberdörster, et al., “Principles for Characterizing the Potential Human Health Effects from
         Exposure to Nanomaterials: Elements of A Screening Strategy,” Particle and Fibre Toxicology, October 6,
         2005, 2:8, available at http://www.particleandfibretoxicology.com/content/pdf/1743-8977-2-8.pdf, acces-
         sed January 3, 2007 (ILSI Report); Gunter Oberdörster, et al., “Translocation of Inhaled Ultrafine Particles
         to the Brain,” Inhalation Toxicology, June 2004, 16: 6-7, p. 437.
     18. ILSI Report, p. 33.
                                                     Thinking Big About Things Small             2

provide incentives for such companies inter-     relationships, need further clarification.
ested in proactive testing of their products.    While this report does not attempt to ad-
Government can also play an important role       dress these topics, they are important ques-
in the development of new, faster toxicity       tions that will need attention.
testing and screening methods that firms             Nonetheless, even in a mature oversight
could use during product development to          system, the need for more information
identify potential problems.                     about nanoscale materials and a reliance
                                                 on “regulation by analogy” will co-exist.
When Is New Testing Needed?                      These trends are ultimately compatible.
Two of the trends described above may            The need for more information about na-
appear inconsistent. As just discussed, it is    noscale materials derives from certain chal-
likely that effective oversight of nanoscale     lenges that are inherent in oversight, such
materials will require more information          as translocation of nanomaterials in the
than is typically required for the review        body and understanding of their surface
of traditional chemicals. At the same time,      characteristics. Thus, the starting point for
it has been argued that oversight agencies       the oversight system is that the information
will often depend on analogies to other          needs will be robust.
materials in evaluating the risks of nanos-          Over time, as science and oversight ma-
cale materials.                                  ture, a series of factors will warrant cali-
   In a sense, there is an inconsistency in      bration of those information needs. Use
how these trends are proceeding at the cur-      patterns for products containing nanoscale
rent time. Some nanoscale materials are          material will certainly influence informa-
moving into commerce without specific            tion needs. For example, oversight of a na-
evaluation of their health and environmen-       noscale material in a consumer product that
tal implications, reflecting an assumption       is broadly dispersed will require more infor-
that the potential effects of nanoscale ma-      mation than evaluation of a site-limited in-
terials are similar to those of the macroscale   termediate in a contained industrial process.
version of the same material. In other cases,    Similarly, some product manufacturers and
very similar nanoscale materials are receiv-     users may adopt risk management measures
ing more intensive evaluation, either by         that mitigate certain concerns, reducing the
governments or by individual companies           need for certain data. For example, a manu-
with robust product stewardship programs,        facturer may prevent discharges to surface
before they proceed to market.                   water and thereby avoid the need to conduct
   Why is this occurring? The current over-      aquatic ecotoxicity testing.
sight system for nanotechnology is imma-             In this same manner, oversight of a par-
ture. The various actors who are expected        ticular nanoscale material may rely on anal-
to conduct oversight do not have a common        ogies to other materials, either at the nano
view of risk criteria and information needs.     or macro scale, to define the potential risk
In addition, the institutional roles concern-    of the material. Such analogies can reduce
ing oversight, running the gamut from the        or increase the scope of potential testing.
jurisdiction of regulatory programs to con-      In some cases, an oversight body evaluat-
tractual obligations in customer-supplier        ing a particular material will base its risk
22

     assessment on the toxicity database for an             Who Can Support
     analogous material and waive the need for              Testing Obligations?
     further testing. In other cases, risk-based            The debate on testing needs will center pri-
     analogies will spur additional testing. For            marily on scientific and policy questions
     example, an oversight body could draw an               about what is needed to understand poten-
     analogy that creates a “worst-case” pre-               tial risk. Beneath the surface, however, will
     sumption about a particular material. This             be an important economic implication: what
     approach creates an incentive for manufac-             kinds of companies can participate in the
     turers to generate additional toxicity testing         commercialization of products containing
     and to demonstrate that such a worst-case              nanoscale materials? Eventually, the high
     presumption is not warranted.                          cost of information collection for nanoscale
        Another factor that can influence the               materials creates a tipping point at which it
     scope of needed testing is the production              is no longer feasible for small companies to
     volume for a product. It is fairly common              bear the costs of the oversight system. This
     in current regulatory programs to establish            is important because much of the innova-
     “testing triggers” for particular substances           tion in nanotechnology is emerging from
     that ratchet up testing obligations on the             small companies around the world.
     basis of higher production volumes. This                   Some may characterize such a regulatory
     approach has the advantage of creating a               hurdle as a barrier to innovation. While
     nexus between testing rigor and potential              there is some merit to this argument, the
     risk, while also addressing the affordability          more practical implication is that it changes
     of testing for the manufacturer.                       the economic model for commercializa-
        A reliance on production volume to                  tion. In many areas of current technology,
     guide information needs is likely to be con-           small companies are at the cutting edge of
     troversial for nanoscale materials. As an ex-          innovation. Once these companies develop
     ample, some stakeholders have maintained               new ideas, they take steps to perfect their
     that certain volume-based exclusions from              intellectual property (i.e., obtain appropri-
     the standard review policies of the TSCA               ate patents) and establish, often with support
     new chemical program are not appropri-                 from external investors, the economic vi-
     ate for nanoscale materials, arguing that              ability of their technology.
     these materials could have significant health              These companies then face a crossroads:
     or environmental effects at relatively low             should they commercialize the product
     production volumes.19 Thus, an important               themselves, or sell or license the technol-
     question that the oversight system will need           ogy to others? If the costs of needed regula-
     to address at an early stage is what informa-          tory clearances are low, they may obtain the
     tion needs should be met before a nanoscale            clearances themselves because, at a mini-
     material enters commerce and what types                mum, the clearances can increase the value
     of information can be addressed later, as the          of the product to potential business partners.
     market for the material develops.                      If the cost of regulatory clearance becomes

     19. Letter from Richard Denison and Karen Florini, Environmental Defense, to Susan Hazen, Acting Assistant
         Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection
         Agency, September 2, 2004, p. 4.
                                                          Thinking Big About Things Small                2

too high, they will sell or license the tech-         pesticide companies do not receive enough
nology to larger companies that have the              return on pesticide sales to justify the data
capital and expertise to manage the regula-           collection obligations they must meet to
tory process.                                         support some minor uses. Thus, many
    At this stage in the development of nano-         minor uses of pesticides have been dropped
technology, it is not yet clear whether the           from pesticide labels, even though more ef-
commercialization of nanoscale materials              fective and environmentally protective use
will become primarily the business of large,          of those pesticides could probably have been
highly capitalized companies, relying on              developed.
their own research and the ideas of small                 At this time, it is still too early to tell
innovator companies, or be a pathway that             whether situations analogous to the minor
turns small innovator companies into the              use pesticide problem will develop in niches
large companies of tomorrow. Many eco-                of the nanotechnology world. The possibil-
nomic factors influence that trend, but the           ity of such an issue is not necessarily a reason
costs of the informational requirements of            to avoid defining information needs that dif-
the oversight system generally play a signifi-        fer by use patterns. At the same time, com-
cant role. For example, few small companies           panies and government agencies may need
can take a new drug to market, in part be-            to consider whether legitimate information
cause they do not have resources and exper-           requirements are creating disincentives that
tise to navigate the FDA regulatory process.          conflict with larger social goals. Corrective
                                                      measures can be taken. For example,
What Products Are Viable?                             Congress has created programs supporting
The information needs of a nanotechnology             “orphan drugs”—drugs used to treat rare
oversight system may also affect the range            diseases affecting only a small portion of the
of applications for which nanotechnology is           population—recognizing that the economic
used. This depends on whether the infor-              dynamics of pharmaceutical development,
mation requirements will differ significan-           including the costs of the oversight system,
tly depending on the product application.             do not favor development of such drugs.20
    By analogy, EPA and the U.S.
Department of Agriculture (USDA) have                 A Starting Point for Discussion
been concerned for many years about how               The needed debate on the information needs
to protect “minor uses” of pesticides. The            for effective oversight of nanoscale materials
EPA pesticide regulatory program calls on             has a useful starting point. In October 2005,
pesticide manufacturers to provide exten-             the International Life Sciences Institute (ILSI)
sive information on pesticide use and food            released a report describing the views of an
residues for each of the agricultural crops on        expert working group on the elements of a
pesticide product labels. However, for many           screening strategy for nanoscale products.21
vegetable and fruit crops that are grown in           This document, which reflects the views of
much smaller quantities than commodity                a cross-section of academic, government and
crops such as corn, soybeans and wheat, the           industry scientists, sets a framework for the

20. For description of FDA’s program under the Orphan Drug Act, see http://www.fda.gov/orphan/.
21. ILSI Report, supra note 17.
24

     kinds of testing that should be considered for   entry”) and the potential translocation of
     screening nanoscale materials.                   the substance in the body.
        The ILSI document reinforces the as-             The document does not attempt to de-
     sumption, held by many scientists, that test-    fine particular testing protocols. It also does
     ing programs for nanoscale materials are         not attempt to recommend policies on min-
     likely to include significant analytic work      imum testing requirements or specify what
     on the physical and chemical properties of       conditions should trigger specific tests. The
     the materials themselves, both in their pure     range of testing outlined in the ILSI paper,
     “nano” form and in their form in a commer-       however, serves as a reminder that the po-
     cial product. Beyond that, the ILSI paper        tential scope, and thus expense, of needed
     describes a range of in vitro and in vivo        testing could be significant. It underscores
     tests that should be considered for various      the need for a serious discussion of what the
     substances, influenced by the initial route      testing obligations should be in a nanotech-
     of exposure to the substance (the “portal of     nology oversight system.
                                                     Thinking Big About Things Small              2

risk management
As indicated earlier, this report focuses on     specific risk management approaches that
the design elements of a product oversight       can be articulated on labels.
system for nanotechnology. This is an im-            Product oversight systems have difficulty
portant context when looking at risk mana-       addressing issues related to environmen-
gement measures because product oversight        tal releases of materials during use and the
systems are inherently better at addressing      waste management scenarios that arise with
some kinds of issues than others.                products at the end of their life cycle. The
                                                 conditions under which these environmen-
Aligning Risk Management                         tal releases occur are rarely understood at
with Product Life Cycle                          any level of precision when a product is first
A product oversight system is well-suited        being introduced into commerce, the typi-
to address product design measures that can      cal point at which product oversight systems
help reduce risk. For example, such a system     consider risk management.
can mandate certain coatings or other pro-           For example, carbon nanotubes are pres-
duct formulations and delivery measures that     ently being used in sporting goods, conduc-
minimize exposures to nanoscale materials.       tive composites, batteries, fuel cells, solar
Also, product oversight systems are usually      cells, biomedical devices, fibers, fabrics and
effective in addressing concerns about wor-      sensors. Since this array of uses presents a
ker exposure or product quality at the point     range of exposure scenarios, it is hard to
of manufacture. The entities involved in the     imagine how to design a single label for the
manufacturing stage of the material’s life       base product that would address the poten-
cycle are typically involved in the process of   tial health, safety and environmental risks in
obtaining clearance for the product.             any great depth.
    Product oversight systems are also well-         Product oversight systems usually rely
suited to risk reduction strategies based on     on label requirements as the means to de-
labeling and other forms of communication        fine management practices at points where a
to customers. These strategies may include       product is processed or used. These systems
directions for use, warnings and general in-     do not usually employ permits, emission-
formation about the product’s content.           monitoring protocols and record-keeping
    Reliance on these strategies, however,       requirements to tailor requirements to par-
can become less effective as the chain of        ticular points of use. Thus, a product over-
distribution gets longer and multiple par-       sight system can have difficulty determining
ties are using, formulating or modifying a       whether appropriate risk management mea-
manufactured product. Similarly, a product       sures have been put in place.
oversight program is challenged when the             Given these strengths and weaknesses
range of applications for a regulated material   of product oversight systems, the question
expands. It becomes increasingly difficult       to consider for nanotechnology is where,
for the oversight system to anticipate all the   in the product life cycle, risk management
exposure scenarios and translate them into       measures are most needed. Several current
2

     efforts would suggest that an important pri-           controls on the design and manufacture of
     ority is to develop appropriate occupational           end products using a nanoscale material may
     controls for the manufacture of nanoscale              be a critical strategy for risk management,
     materials because workers will be the most             which may generate end-product perfor-
     exposed population.22 Given that focus, a              mance testing requirements.
     product oversight system is likely to lead                 Risk management strategies will have to
     to an effective risk management strategy.              be aligned with testing strategies in other
     Measures related to occupational controls              ways as well. A particularly important set of
     and hazard communication are well-estab-               policies relates to how risk management ap-
     lished elements of existing product over-              proaches can be used as alternatives to test-
     sight programs.23                                      ing requirements. If a company is prepared
         If, however, concerns develop about the            to accept certain controls in the design of
     release of nanoscale materials into aquatic            its product, in its manufacturing process or
     environments at points of processing or use,           in its product labeling, can it avoid the ex-
     existing programs for product oversight may            pense of undertaking certain kinds of test-
     not be as effective. FDA, for example, would           ing? Such trade-offs are routinely employed
     not have great expertise about water pollu-            in existing regulatory programs. How will
     tion control strategies. Even within EPA,              this concept apply to nanoscale materials?
     the TSCA new chemical program tends to                     The role of monitoring in risk manage-
     address water pollution concerns for new               ment strategies for nanoscale materials is
     chemicals with fairly rudimentary control              an extremely important consideration. It is
     measures, such as a prohibition of “inten-             broadly understood that monitoring for na-
     tional” discharges to water, but not specific          noscale materials in products, workplaces and
     wastewater discharge limits.                           the environment is going to be a difficult and
                                                            potentially expensive task. Proven methods
     Interplay Between                                      are not readily available. While methods will
     Risk Management and                                    probably be developed at some point, it is not
     Information Collection                                 at all clear that the cost of routine monitoring
     Risk management strategies must necessa-               using those methods will be reasonable.
     rily be aligned with information collection                If low-cost monitoring methods are not
     expectations. As suggested earlier in this re-         available, the range of effective risk manage-
     port, the oversight system must decide whe-            ment measures narrows. Reliable and cred-
     ther to focus just on the nanoscale material           ible monitoring protocols are essential for
     itself or on the whole product in which the            the development of “performance standards”
     nanoscale material is contained and marke-             that give companies flexibility to develop
     ted. This is important for developing a risk           cost-effective measures to meet a risk reduc-
     management, as well as an information co-              tion goal. For example, workplace exposure
     llection, strategy. For example, establishing          concentrations and environmental emissions

     22. The voluntary standards group ASTM International formed a committee in 2005 to, among other topics,
         develop good management practices for worker protection. See ASTM E56, at http://www.astm.org.
     23. For example, the TSCA new chemical program often relies on mechanisms established under the
         Occupational Safety and Health Administration’s hazard communication program to assure that appropriate
         information about chemical management is delivered to workers.
                                                                Thinking Big About Things Small                       2

standards are typically linked to monitoring                   To the extent that a “nano” label is meant
requirements. Without practical monitor-                   to carry an implied hazard warning, there
ing protocols, risk management strategies                  will be significant opposition to this idea.
will be limited to design requirements or                  Many supporters of nanotechnology believe
management practices that are expected to                  that most nanotechnology materials, par-
reduce exposure. At a facility level, effective            ticularly as used in the commercial products
end-of-pipe and fence-line monitoring can                  offered to consumers, will not represent
be used to provide companies with greater                  substantial public risks.
flexibility for process changes, but cost-ef-                  Other stakeholders will start from a dif-
fective monitoring methods for nanoscale                   fering set of assumptions. For example,
materials do not yet exist.                                some will argue that the potential for trans-
                                                           location of nanoparticles within the body
The Role of Labeling                                       represents an exposure that should be iden-
Finally, the nature of labeling for nanoscale              tified to consumers. In the experience with
materials is likely to be a key policy con-                genetically modified organisms (GMO) in
cern. In particular, there will be substantial             food, the issue of “GMO labeling” was one
debate about whether a product containing                  of the most divisive issues discussed in pub-
nanoscale materials should have a label that               lic policy debates about the technology.
explicitly notifies the public that a nanoma-                  Some parties may argue as a general mat-
terial is in the product.                                  ter that there is a “right to know” about the
    In discussing this issue, it will be impor-            presence of nanoscale materials in a product.
tant that stakeholders consider why such la-               Yet that assertion begs the question of how
beling would make sense.24 If, for example,                the information should be used. The Toxic
the government has an interest in tracking                 Release Inventory (TRI) program’s prem-
where nanomaterials are being used in the                  ise that communities should know about
economy, there are several mechanisms,                     chemical releases in their neighborhoods
other than labeling, that can be used to ob-               was certainly valid. Yet that program re-
tain that information.                                     quired notification only for a list of chemi-
    Labeling is generally intended to help the             cals that Congress or EPA had identified as
consumer use a product in a manner that is                 “toxic chemicals.” How the TRI analogy
effective for its intended purpose and that                might apply to nanoscale materials, particu-
is safe. Contextual information, such as the               larly those that have not yet been linked to
ingredients of the product and hazard warn-                a negative health or environmental impact,
ings, also provides reinforcement of those                 will be quite controversial.
primary objectives. Assuming these are the                     Questions about the potential use of
appropriate objectives for labeling, policy-               “nano” labeling will be divisive because they
makers will need to define what objectives                 are about values. There is no scientific an-
are served by a “nano” label, particularly if              swer to these questions. For this reason alone,
labeling is broadly required.                              it is a subject that deserves attention soon.

24. Given the popularity of nanotechnology at this time, some companies are advertising the presence of nanos-
    cale materials in their products. In this situation, the only apparent role of an oversight system is to assure
    that the product’s claims are factually correct.
2

     conclusion: the issue of transparency
     The matter of how “public” the elements                   A
                                                            •	 	 company’s planned production vo-
     of the nanotechnology oversight system                    lume for a material is routinely viewed as
     should be is an essential question that must              confidential.
     be answered. Several groups have already
     made it quite clear that transparency of the              T
                                                            •	 	 he process used to manufacture a par-
     process and the basis for risk decisions is es-           ticular substance is almost always trea-
     sential if the oversight system is to be credi-           ted as confidential information by the
     ble.25 In addition, recent focus groups that              manufacturer.
     explored public attitudes and perceptions of
     nanotechnology found that disclosure and                  S
                                                            •	 	 imilarly, companies will view informa-
     transparency were critical to building public             tion about their customers and downs-
     confidence in the ability of government and               tream distribution networks as the es-
     industry to manage risks associated with na-              sence of their business and, thus, highly
     notechnology.26 Few could argue with the                  confidential.
     general reasonableness of transparency for
     these purposes.                                           S
                                                            •	 	 tatutory protections of trade secrets do
        At the same time, product oversight sys-               not generally extend to health and safety
     tems are usually accompanied by under-                    studies, which are typically viewed as pu-
     standable sensitivity about public disclosure             blic information. In some cases, compa-
     of information in the following areas:                    nies will contend that information about
                                                               the specific identity of a chemical subs-
        W
     •	 	 hen a new material is first being eva-               tance should be treated as confidential.
        luated by government agencies, the spon-
        sor of the product will not want the iden-             F
                                                            •	 	 inally, companies often look for ways to
        tity of the product disclosed because this             assure that other companies cannot use
        information discloses business strategy to             their health and safety data, particularly
        competitors. This sensitivity usually de-              in obtaining clearances with regulatory
        clines once the product has been com-                  authorities, without some form of com-
        mercialized and is available for evalua-               pensation. This can sometimes lead to
        tion, and reverse engineering, by those                rules about who may have access to cer-
        competitors.                                           tain health and safety studies.27


     25. John Balbus, et al., “Getting Nanotechnology Right the First Time,” Issues in Science and Technology,
         Summer 2005, p. 70; National Resource Defense Council, “Nanotechnologies: Tiny Particles Promise
         Much, But Could Pose Big Risk,” March 20, 2005, available at http://www.nrdc.org/health/science/nano.
         asp, accessed January 3, 2007.
     26. Jane Macoubrie, Informed Public Perceptions of Nanotechnology and Trust in Government, Washington, DC:
         Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, September
         2005.
     27. Section 10(g) of the Federal Insecticide, Fungicide and Rodenticide Act provides an example of how this
         issue is addressed in EPA’s pesticide program.
                                                          Thinking Big About Things Small                 2

   Stakeholders will need to decide for               make. From that grounding, options can
themselves whether aspects of this pattern            be explored about assembling information
raise concerns. Those who believe that                in differing ways that do not threaten or
more information should be available in               compromise core business confidential-
one of these areas should be prepared to ex-          ity concerns. Hopefully, all parties can
plain what is needed and why. At that point,          feel adequately informed within the lim-
the real discussion about transparency can            its of the information that can be made
begin, hopefully in the context of a realistic        available.
view of risk communication.
   In its report Improving Risk Communication,        A Final Note
the National Research Council of The                  In the end, there are many reasons to be
National Academies offers a helpful, prag-            optimistic that nanotechnology will pros-
matic guide to what the goal should be in             per and expand exponentially over the next
discussing transparency:                              several years. One reason for that optimism
                                                      is that a broad spectrum of interests is now
     “Risk communication is successful                looking for opportunities to collaborate on
     only to the extent that it raises the            strategies to manage the health, safety and
     level of understanding of relevant               environmental issues that might arise with
     issues or actions and satisfies those            nanoscale materials.
     involved that they are adequately                    The window of opportunity to make
     informed within the limits of avai-              real progress on this front, however, will
     lable knowledge.”28                              not be open forever. For this reason, it is
                                                      essential that all stakeholders interested in
   Good risk communication does not mean              responsible management of this technology
that all participants agree on questions of           begin to focus their energy on defining the
values and appropriate decisions about risk,          core building blocks that define a product
either as a public policy matter or at the level      oversight system: (1) risk criteria; (2) in-
of personal choice. It simply means that they         formation needs; and (3) risk management
are receiving sufficient information to reach         measures. In addition to focusing on these
their own conclusions.                                building blocks, stakeholders must engage
   To the extent there are significant de-            in pragmatic discussions about the ground
bates about regulatory transparency con-              rules for transparency.
cerning nanoscale materials, it will be                   The need for this discussion is no more
important that stakeholders identify the              distant than nanotechnology itself. And this
kinds of decisions they want to be able to            means that the time for it is now.

28. The National Academies, Improving Risk Communication, Washington: DC: National Academy Press, 1989.
0

     selected Additional Products From the
     Project on emerging nanotechnologies*
     Reports                                       J. Clarence Davies, “Developments in
     PEN 1: Jane Macoubrie, Informed Public        Nanotechnology,” United States Senate,
     Perceptions of Nanotechnology and Trust in    Committee on Commerce, Science and
     Government, September 2005.                   Transportation, February 15, 2006.

     PEN 2: J. Clarence Davies, Managing the       David Rejeski, “Promoting Economic
     Effects of Nanotechnology, January 2006.      Development Opportunities Through
                                                   Nano Commercialization,” United States
     PEN 3: Andrew D. Maynard,                     Senate, Committee on Commerce,
     Nanotechnology: A Research Strategy for       Science and Transportation, Subcommittee
     Addressing Risk, July 2006.                   on Trade, Tourism and Economic
                                                   Development, May 4, 2006.
     PEN 4: Jennifer Kuzma and Peter
                                                   Andrew D. Maynard, “Research on
     VerHage, Nanotechnology in Agriculture and
                                                   Environmental and Safety Impacts of
     Food Production: Anticipated Applications,
                                                   Nanotechnology: What Are the Federal
     September 2006.
                                                   Agencies Doing?,” United States House of
                                                   Representatives, Committee on Science,
     PEN 5: Michael R. Taylor, Regulating the
                                                   September 21, 2006.
     Products of Nanotechnology: Does FDA Have
     the Tools It Needs?, October 2006.
                                                   Inventories
                                                   Nanotechnology Environment, Health and
     PEN 6: Karen F. Schmidt, NanoFrontiers:
                                                   Safety Risk Research, released November 2005.
     Visions for the Future of Nanotechnology,
     March 2007.                                   Nanotechnology Consumer Products,
                                                   released March 2006.
     Congressional Testimonies
     David Rejeski, “Environmental and             Agrifood Nanotechnology Research and
     Safety Impacts of Nanotechnology: What        Development, released March 2006.
     Research Is Needed,” United States House
     of Representatives, Committee on Science,     Nanotechnology and Medicine, released
     November 17, 2005.                            October 2006.

     * These and other materials are available at http://www.nanotechproject.org.
WoodroW Wilson international Center for sCholars
Lee H. Hamilton, President and Director

board of trustees
Joseph B. Gildenhorn, Chair
David A. Metzner, Vice Chair

Public members
James H. Billington, Librarian of Congress; Bruce Cole, Chair, National Endowment for the
Humanities; Michael O. Leavitt, Secretary, U.S. Department of Health and Human Services;
Condoleezza Rice, Secretary, U.S. Department of State; Lawrence M. Small, Secretary,
Smithsonian Institution; Margaret Spellings, Secretary, U.S. Department of Education; Allen
Weinstein, 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, Tamala L. Longaberger, Ignacio Sanchez



The Project on emerging nanotechnologies was launched in 2005 by the Wilson
Center and The Pew Charitable Trusts. It is dedicated to helping business, governments, and
the public anticipate and manage the possible human and environmental implications of
nanotechnology.

the Pew charitable trusts serves the public interest by providing information, advancing
policy solutions and supporting civic life. Based in Philadelphia, with an office in Washington,
D.C., the Trusts will invest $248 million in fiscal year 2007 to provide organizations and
citizens with fact-based research and practical solutions for challenging issues.

The woodrow wilson international center for scholars is the living, national memorial
to President Wilson established by Congress in 1968 and headquartered in Washington,
D.C. The Center establishes and maintains a neutral forum for free, open and informed
dialogue. It is a nonpartisan institution, supported by public and private funds and engaged
in the study of national and international affairs.
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Nanotechnologies
One Woodrow Wilson Plaza
1300 Pennsylvania Ave., N.W.
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