Abstract
Domestic laws, their implementing regulations and policies, and government and private-party governance programs are now being carefully reviewed and revised to enhance their utility to manage the potential risks posed by nanoscale materials. Whether existing laws and their implementing programs are adequate to address such risks will continue to inspire debate and legislative and regulatory initiatives for years to come. This article reviews existing legal and governance oversight systems and analyzes their strengths and deficiencies in addressing the potential risks posed by nanoscale materials and in fostering nanotechnology's promise. Particular attention is devoted to emerging regulatory approaches the US Environmental Protection Agency is taking under the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act, the two domestic chemical product laws primarily responsible for ensuring the safety of chemical substances and mixtures.
Governments globally are focusing on nanotechnology for reasons beyond economic advancement. Because there is a lack of complete understanding regarding the environmental, health, and safety (EHS) effects of exposure to engineered nanoscale materials, government bodies and industry are considering how best to address EHS issues while fostering the commercialization of nanoscale materials. It is generally believed that sufficient information exists about the potential toxicity of nanoscale materials to suggest a need for caution. The small size of certain nanoparticles facilitates their uptake into cells and their movement through the body more readily than is the case with their macrocounterparts. 3 *
In addition to size, however, other factors contribute to a general sense of uncertainty as to the biologic and environmental implications of exposure to engineered nanoscale materials. The complexity of engineered nanomaterials means that their impact will depend on more than chemistry alone. Size, shape, surface chemistry, and surface coating, for example, can all influence how these materials behave biologically and in the environment. In some instances, the fact that nanoscale materials can have unusual properties—properties that do not conform to “conventional” physics and chemistry—may increase their commercial value and their potential for risk.
Many federal agencies are engaged in the active review of nanotechnology applications and the EHS implications of nanotechnologies. These include the Environmental Protection Agency (EPA), 4 the Food and Drug Administration (FDA), 5 the Occupational Safety and Health Administration (OSHA), 6 the National Institute for Occupational Safety and Health (NIOSH), 7 the National Toxicology Program, 8 and the Department of Defense, 9 among other federal agencies and departments. Regulatory and health agencies globally are similarly engaged. The EPA is most prominently involved in reviewing the EHS implications of nanotechnologies and in identifying and funding research initiatives regarding the beneficial environmental applications of nanotechnologies in a wide variety of areas. 10
The products of nanotechnology are diverse and growing exponentially. According to the National Nanotechnology Initiative, nanoparticles and nanoscale materials are used in many industries, including electronics, pharmaceuticals, chemicals, energy, among others. Reportedly, areas producing the greatest revenue for nanoparticles are chemical and mechanical polishing, magnetic recording tapes, sunscreens, automotive catalyst supports, biolabeling, and electroconductive coatings and optical fibers. According to one source, over 1,000 manufacturer-identified nanotechnology-enabled products are currently on the market, including paints, sporting goods, cosmetics, stain-resistant clothing, electronics, and surface coatings, among other applications. 11
The uncertainty of nanotechnology, its health and safety implications, its commercial applications, the public's receptivity to nanotechnology, and the global governance mechanisms that may be applied to manage the risks potentially arising from nanoscale materials do not play well to an increasingly cautious public or the investment and insurance industries, whose support for the successful commercialization of this technology is essential. The hope is that prudent business practices will prevail, the promise of nanotechnology will materialize, and the science will unfold in ways that support its continued commercialization. In the interim, business people will be challenged to address increasingly complex legal, commercial, regulatory, and public relations issues, as summarized below.
Potential Liabilities and Governance Systems
Nanotechnology companies face a range of potential liabilities. Assessing and quantifying these potential liabilities are difficult to do given the relative embryonic stage of the field, the lack of well-defined legal precedent and regulatory governance standards, evolving industry standards and practices, and the fast-developing science. Several areas of potential liability warrant note here.
Product Liability
The specter of product liability casts a shadow over nanotechnology innovations. The “Magic Nano” product became the poster child for nanotechnology product liability concerns following its recall and a relentless stream of bad publicity. Magic Nano was first sold in supermarkets and discount stores in March 2006 in Germany. The product was a household glass and ceramic tile sealant available in aerosol cans. According to the German Federal Institute for Risk Assessment, 12 between March 27 and March 30, 2006, almost 100 people who used the product claimed to experience breathing problems requiring hospital treatment. It was ultimately determined that the product contained no nanoparticles. That the product contained no nanoscale materials, and decidedly no magic, is irrelevant in the court of public opinion, however, and the incident was widely regarded as a wake-up call to industry as to the mischief “nanotechnology” can inspire. Strict liability, negligence, breach of warranty, and claims made in connection with these legal principles (eg, design defect, manufacturer defect, and failure to warn) arguably could be asserted against manufacturers or suppliers of nano-enabled consumer products, given the right facts. Claims for damages could include personal injury, medical monitoring, fear of future injury, deceptive trade practices (inviting treble damages), and punitive damages.
Although no reported litigation appears to have been brought as of mid-2010 involving nanotechnology or a nano-enabled product, many believe that this could change in the not too distant future. 13 The full range of protective measures to minimize product liability must be considered, including contractual protections with upstream and downstream suppliers; implementation of best management practices; contractual representations and warranties; indemnification agreements; and appropriate and legally sound warnings, labeling, and related disclosure strategies. Additionally, businesses need to track postsale consumer product complaint and incident reports and respond to any quickly and thoroughly.
Businesses also must respond to the relentless pressure to communicate with diverse stakeholders about the technology they employ—stakeholders including workers, community residents, downstream customers, distributors, and others—each of which can be expected to seek and need to know what a nano-enabled product contains, the health implications from exposure to the product and its nano components, the end-of-life consequences of nano-enabled products, and related product composition and safety information. Stakeholders have come to expect even greater information given demanding right-to-know laws and the expectations they invite.
In addition to these right-to-know disclosure pressures, increasingly demanding shareholder rights activists can be expected to continue to insist on enhanced transparency and product disclosure with regard to a wide array of issues, particularly environmental and product toxicity issues. On December 11, 2008, for example, a coalition of activists wrote then President-Elect Obama asking that investors be afforded a right to propose and vote on resolutions directing a company to evaluate how specific risks may affect the company's business. Among the types of risks the coalition specifically identified were “climate change and product toxicity.” 14
Similarly, the advocacy group As You Sow Foundation's Corporate Social Responsibility Program noted in early 2009 that product safety shareholder resolutions urging companies to disclose the presence of nanomaterials in food and personal care products have greatly increased in the recent past. 15 According to the Investor Environmental Health Network, shareholders filed or refiled 62 resolutions at 39 companies for consideration at shareholder meetings between 2008 and 2009.16,17 Many of these specifically requested information on nanomaterials.
Although the Obama administration has yet to take up this type of disclosure, the EPA has made greater transparency a core agency priority. On December 23, 2009, for example, the EPA requested comment on options for disclosing inert ingredients in pesticides 18 † and ideas for greater disclosure of inert ingredient information. Inert ingredients are part of the end-use product formulation and are not active ingredients.
As another example, on January 21, 2010, the EPA announced a new practice concerning confidential business information (CBI) claims for substantial risk information submitted to the EPA under Toxic Substances Control Act (TSCA) Section 8(e). 19 According to the EPA's announcement, if a chemical substance is listed on the public portion of the TSCA inventory, the EPA expects that a company submitting a health and safety study to the EPA under TSCA Section 8(e) for that chemical substance will not claim the chemical identity as confidential. According to the EPA, “[t]his action is part of a broader effort to increase transparency and provide more valuable information to the public by identifying programs where non-CBI may have been claimed and treated as CBI in the past.” 19
More recently, on May 27, 2010, the EPA announced that it will begin a “general practice” of reviewing confidentiality claims for chemical identities included in health and safety studies and in data from health and safety studies, submitted under the TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B. 20 According to the EPA, TSCA Section 14(b) does not extend confidential treatment to health and safety studies or data from health and safety studies that, if made public, would not disclose confidential processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture composed of any of the chemical substances in the mixture. Where a chemical identity does not explicitly contain confidential process information or reveal portions of a mixture, the EPA stated that it expects to find that the information would clearly not be entitled to confidential treatment.
Insurance
The uncertainties noted above help explain the formidable challenges that insurance coverage presents both to carriers in providing coverage and to businesses in obtaining it. The key issue in insuring against liabilities where nanotechnology is involved is the relative lack of certainty regarding potential EHS risks. Swiss Re's often-cited report, Nanotechnology: Small Matter, Many Unknowns, bluntly states that, in the case of nanotechnology, uncertainties prevail because “neither the probability nor the extent of the potential losses are precisely calculable,” and businesses can expect to see creative approaches by the insurance industry as it tries to address a growing need among an expanding client base that relies on nanotechnology. 21 This may mean that some risks will be explicitly excluded from coverage because some essential element in the calculus is too speculative.
In April 2010, Lexington Insurance introduced what appears to be a first-of-its-kind product called LexNanoShield. The product is “integrated liability insurance” that extends explicit coverage for nanotechnology exposures arising out of general liability, product liability, product pollution legal liability, and product recall liability. LexNanoShield claims to reimburse first-party product recall expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons. According to the website, LexNanoShield provides a broad array of services. ‡
Other options that carriers may consider pursuing to address nanotechnology's undefined potential risks include capping coverage at one end or the other (insurers either will pay claims only up to a specified ceiling or will pay the excess only after the insured shoulders a large deductible); other types of risk-pooling agreements; and limitations and exclusions narrowly defined, in the form of bond sales or purchases, among other options. This is an emerging area, and no hard and fast rules yet apply.
Evolving Governance Mechanisms
Traditional governance mechanisms in the United States such as law enactments and/or standard Administrative Procedure Act notice and comment rule makings are thought by some to be challenging and possibly ill-suited tools for addressing potential EHS risks posed by the lightning-fast pace of evolving nanotechnology. As a potential matter, no laws specific to nanoscale materials have been enacted. Most government agencies in the United States and worldwide are of the view that they lack sufficient data and information to make informed judgments on the specific types of potential hazards and risks posed by some nanoscale materials and hence are reluctant to enact laws imposing restrictions that may or may not be warranted. In the interim, the EPA—and regulatory bodies globally—is pursuing more innovative governance strategies to assist in addressing the potential risks associated with nanotechnology. A few of these measures are described below.
US Government-Sponsored Voluntary Initiatives
In the absence of data on nanoscale materials, the EPA under the Bush administration created a voluntary disclosure process called the Nanoscale Materials Stewardship Program (NMSP), managed by the Office of Pollution Prevention and Toxics. In preparation for the program, the EPA developed a draft NMSP concept paper that outlined its “initial thinking on the design and development” of the NMSP and explained, among other matters, that the program would consist of two parts: a “Basic Program” and an “In-Depth Program.” 23 The EPA solicited comment on the concept paper.
After reviewing comments on the NMSP documents, the EPA formally launched the NMSP on January 28, 2008. Under the first part of the NMSP, the Basic Program, participants were invited voluntarily to report available information on the engineered nanoscale materials they manufacture, import, process, or use. Under the In-Depth Program, participants voluntarily develop data over a longer period of time, alone or in consortia, for a particular nanoscale material.
On January 12, 2009, the EPA released its interim report on the NMSP. 24 The EPA stated that, based on the current interim results, “the NMSP can be considered successful.” The EPA noted that a number of EHS data gaps still exist, however, and it “is considering how to best use testing and information gathering authorities under [the TSCA] to help address those gaps.” The EPA stated then, and has reaffirmed its view, 25 that it will continue to review new chemical nanoscale materials submitted under TSCA Sections 5(a) and 5(h)(4) and apply, as appropriate, testing requirements and exposure controls under Section 5(e) and significant new use rules (SNURs) under Section 5(a)(2). The EPA's NMSP concluded in December 2009.
The NMSP generally has been viewed as a failure. EPA Assistant Administrator for Toxics Steve Owens called the voluntary program “less than a resounding success” on September 10, 2008. 26 The NMSP, on the whole, did not provide the information that the EPA expressed interest in obtaining. As a result, the EPA has opted to avail itself of more traditional governance tools, most notably rule makings under the TSCA and enforcement of existing laws, which are discussed infra.
The EPA also works extensively with international organizations on voluntary initiatives to understand and address the environmental applications and implications of nanotechnology. The Organization for Economic Cooperation and Development (OECD) established the Working Party on Manufactured Nanomaterials (WPMN), and the EPA is actively participating in the WPMN and contributes to all of these projects. Of particular relevance is the project on safety testing of a representative set of manufactured nanomaterials. The WPMN has identified a representative list of manufactured nanoscale materials for EHS testing, including fullerenes (C60), single- and multiwalled carbon nanotubes (CNTs), silver nanoparticles, iron nanoparticles, carbon black, titanium dioxide, aluminum oxide, cerium oxide, zinc oxide, silicon dioxide, polystyrene, dendrimers, and nanoclays. The WPMN has also published a list of testing end points in the following areas: nanomaterial information and identification, physical and chemical properties, material characterization, environmental fate, environmental toxicology, mammalian toxicology, and material safety.
The EPA's Office of Pesticide Programs (OPP) also is active in nanotechnology. The OPP formed an intraoffice workgroup of 20 members several years ago to develop a regulatory framework and to assist in the examination of hazard, exposure, policy, regulatory, and international issues arising in connection with nanoscale materials used as pesticides, including antimicrobial pesticides. § The OPP's Nanotechnology Workgroup has the job of addressing issues pertinent to nanopesticides. The OPP reportedly began receiving inquiries about registering nanoscale pesticides in 2006, particularly involving antimicrobial uses, and has received at least four formal applications to register a nanoscale pesticide—all antimicrobial products, as discussed below.
The OPP is also coordinating with the OECD Working Party on Pesticides and Task Force on Biocides to develop a survey to gather basic information from OECD member countries on their respective involvement with pesticides and biocides and nanotechnology and to identify the various OECD member countries' regulatory approaches to nanotechnology-related pesticide and biocide issues.
Federal EPA Regulatory Initiatives
The EPA's regulatory initiatives have picked up steam significantly over the past several years. To assist manufacturers in understanding the regulatory status of chemical nanoscale materials, the EPA prepared a policy statement dated January 2008, TSCA Inventory Status of Nanoscale Substances – General Approach. 27 On October 31, 2008, the EPA published an important notice outlining the TSCA requirements potentially applicable to nanoscale materials and advised manufacturers of CNTs of its position that CNTs must be listed on the TSCA inventory. 28 After March 1, 2009, CNTs that are manufactured for commercial purposes and are not listed on the TSCA inventory or are otherwise exempt may be the subject of compliance-monitoring efforts.
The EPA has also received, reviewed, and taken action on many new chemical notices under TSCA Section 5 pertinent to nanoscale materials reflecting enhanced commercial activity with respect to nanoscale materials. On May 7, 2008, the EPA issued a Federal Register notice announcing receipt of a premanufacture notification (PMN) to manufacture sing le-walled CNTs. 29 On November 5, 2008, the EPA issued a final SNUR for 56 substances, 2 of which included nanoscale substances. 30 On January 5, 2009, the EPA announced receipt of several premanufacture notifications concerning multiwalled CNTs. 31 On June 24, 2009, the EPA issued a direct final rule promulgating SNURs from multi- and single-walled CNTs. 32 In light of the adverse public comment, on August 21, 2009, the EPA withdrew the direct final rule 33 and on February 3, 2010, proposed the SNUR. 34
On the FIFRA side of the EPA's Office of Pollution Prevention and Toxics, the EPA announced in April 2010 that sometime in 2010 it intends to adopt a policy that would require any pesticide registrant that is aware that some constituent of a registered pesticide product is nanosized (ie, has particles or structures with a diameter less than 100 nm) to submit the information to the EPA pursuant to FIFRA Section 6(a)(2). 35 EPA regulations generally limit the obligation of a registrant to report information pursuant to FIFRA Section 6(a)(2) to information that concerns “adverse effects,” so this expansion of EPA reporting requirements appears to be based on a premise that EPA regards the mere presence of any nanoscale materials to be “adverse.”
From November 3 to 5, 2009, the FIFRA Scientific Advisory Panel (SAP) met to consider for the first time scientific issues related to the assessment of potential hazard and exposure associated with nanosilver and other nanometal pesticide products. The decision to convene a SAP may have been prompted in part by a May 1, 2008, petition for rule making filed by the International Center for Technology Assessment (ICTA) requesting that the EPA regulate products containing nanoscale silver as pesticides. The petition expressed concern about the potential human health and environmental risks of nanoscale materials and requested that the EPA classify nanoscale silver as a pesticide and require registration. The EPA requested comment on the ICTA petition on November 19, 2008. 36 The OPP noted that it intended to issue a response to the petition after reviewing any public comment and coordinating with the EPA's Office of Enforcement and Compliance Assurance. More information about pesticide nanotechnology issues is available on the EPA website. 37
Since the ICTA filed the petition, the EPA has been asked to consider at least four applications seeking registration of products containing nanosilver-based active ingredients. The nanosilver products would take the form of textile additives, polymers, coatings, and/or plastics and would be used to protect a treated product from microorganisms or to impart antimicrobial activity to a treated material. These products would be used in the same manner as some of the currently registered silver products, including those used as material preservatives and antimicrobial pesticides.
In its background paper to the SAP meeting, 38 the EPA states that the current state of the science does not contain sufficient information to determine definitively whether (and, if so, to what extent) various forms of nanosilver particles may cause toxic effects beyond those attributable to the release of silver ions. In light of this, the threshold question before the SAP relates to whether the EPA can make its safety finding under the FIFRA that a pesticide product will not cause unreasonable adverse effects on the environment with respect to the four pending applications.
According to the EPA, the registration applicants assert that the mode of action for nanosilver is the same as for silver in that the release of silver ions is the source of antimicrobial activity. Because the pesticidal mode of action of nanosilver is the same as for conventionally sized silver, the potential hazards to human health and the environment resulting from the use of nanosilver as a pesticide will, therefore, be the same as from the use of silver. The EPA likened the registrants' argument to that of the so-called 0-hypothesis put forward by Wijnhoven and colleagues. 39 The 0-hypothesis is that the toxic effects of nanosilver are proportional to the activity of free silver ions released by the nanoparticles. The question, then, for FIFRA regulatory purposes is whether sufficient data and information exist to determine whether nanosilver particles enter the body, whether nanosilver releases silver ions, and to what extent the ions can be absorbed.
The SAP released the minutes of its November 3 to 5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products. The panel generally concluded that existing models “are not appropriate” for use with silver nanomaterials and “will not accurately predict nanosilver exposure scenarios.” The panel stated that it “strongly believe[s] that in addition to current data requirements under [FIFRA], additional assays which compared nanoscale and bulk materials would be most beneficial in addressing” differences in toxicokinetics and toxicodynamics for nanoscale materials. 40 The panel agreed that pesticide products should be tested on a “case-by-case basis,” the EPA should use a meta-analysis on the products to better understand trends in life-cycle analyses, and “close attention” should be given to products that claim a nonionic mode of action as an antimicrobial agent. The panel outlined detailed and extensive research needs that the EPA should consider requiring to develop information on the potential risks of nanoscale silver. Other countries are considering similar issues. 41
State and Local Regulatory Initiatives
State and local governments are also beginning to focus on the regulation of nanoscale materials from a governance perspective. On December 12, 2006, the Berkeley, California, City Council unanimously approved a proposal to require businesses to report nanoparticles being used, provide available toxicologic information, and outline measures for safe handling of the materials. All businesses that manufacture or use nanoparticles must submit a written report of the current toxicology of the nanomaterials reported and methods for safely handling, monitoring, containing, disposing, and tracking the inventory. 42
On January 8, 2007, the City Council of Cambridge, Massachusetts, asked the Cambridge Public Health Department to review the Berkeley ordinance and recommend a similar statute for Cambridge. The Cambridge Chamber of Commerce solicited the view of companies, laboratories, and other organizations active in the manufacture, research, and/or use of nanomaterials to ensure full industry participation in the City's review of the need for regulation and the possible development of statutes to that end. On July 28, 2008, the City Council voted to accept a set of recommendations for a municipal health and safety policy on nanomaterials. The recommendations were set forth in a report prepared by the Cambridge Public Health Department and the Cambridge Nanomaterials Advisory Committee. 43 ∥ Cambridge thus became the second city in the United States to take municipal action on nanomaterials.
More recently, the California Department of Toxic Substances Control (CDTSC) has been obtaining data and information on nanoscale materials. In a January 22, 2009, letter to stakeholders, the CDTSC announced that it is requiring the submission of data “regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes.” 44 The CDTSC stated that the term “manufacturers” includes persons and businesses that produce CNTs in California or import CNTs into California for sale and identified manufacturers that produce or import CNTs in California, including academic institutions doing CNT research and those manufacturers that are involved in producing or importing CNTs in their chemical form. The CDTSC stated that the call-in “also includes companies outside California who may export carbon nanotubes into the State. Initially, we have not included manufacturers who import products containing carbon nanotubes; however, we may expand the list of manufacturers in the future to include product manufacturers.” 45
On January 25, 2010, the CDTSC posted on its website responses from 17 companies that received a formal information request letter regarding CNTs. 46 The CDTSC also listed the companies that failed to respond by the January 22, 2010, due date and issued follow-up letters to nine companies that reportedly failed to respond timely on February 16, 2010. 46 The CDTSC also expressed interest in other nanomaterials. In 2010, the CDTSC stated that it will be focusing on other nanoscale materials, including nanometal oxides such as nanoscale titanium dioxide and nanoscale zinc oxide, and nanometals such as nanosilver and nano zerovalent iron.
Risk Management and Product Stewardship Strategies
Given the relative paucity of legal and regulatory standards specific to nanomanufacturing operations, nanotechnology businesses and other stakeholders have devoted considerable effort to developing alternatives to traditional “command and control” regulation to identify and manage risk. These strategies are discussed below.
Key Industry Standard-Setting Initiatives
Several major efforts are under way to develop standards involving nanotechnology. International Organization for Standardization Technical Committee 229 is preparing international consensus standards on several aspects of nanotechnology, including vocabulary, terms, and definitions; measurement and metrology; and EHS. 47
ASTM International is working on a similar set of standards. 48 ASTM International Committee E 56 on Nanotechnology is developing standards and guidelines for nanotechnology, specifically including terminology and nomenclature; characterization, environmental, and occupational safety and health; international law and intellectual property; liaison and international cooperation; and standards of care and product stewardship.
Key Government-Led Initiatives
In addition to the NMSP discussed above and related voluntary initiatives mushrooming internationally, the OECD is engaged in a robust nanotechnology program. The OECD is an intergovernmental organization that includes 30 member countries, of which the United States is one, and maintains relationships with 70 others. 49
Two OECD group activities are developed relevant to nanoscale materials. As noted above, in September 2006, the OECD established the WPMN. The chemicals sector is the principal focus of the WPMN, and the EPA, FDA, OSHA, and NIOSH are engaged in the WPMN. Current projects involve nine “sector groups” working on separate projects, including generating an EHS database, developing an EHS research strategy, evaluating existing testing guidelines, safety testing a representative set of manufactured nanomaterials, cooperating and exchanging information on voluntary reporting and regulatory schemes, performing risk assessment and exposure measurement, and developing a life-cycle assessment of nanoscale materials.
In March 2007, the OECD created the Committee on Scientific and Technological Policy, which focuses on considering applications of nanotechnologies. The committee's primary objective is to promote international cooperation that facilitates research, development, and the responsible commercialization of nanotechnology in member countries.
Key Private-Sector Stewardship Initiatives
In June 2007, the Environmental Defense Fund (EDF) and DuPont formally announced the release of their joint effort, the Nano Risk Framework. The framework is rapidly becoming the standard for measuring best management practice in the nanotechnology industry. The framework defines “a systematic and disciplined process for identifying, managing, and reducing potential environmental, health, and safety risks of engineered nanomaterials across all stages of a product's ‘lifecycle’—its full life from initial sourcing through manufacture, use, disposal or recycling, and ultimate fate.” 50
The EDF and DuPont began their collaborative effort to develop the framework in September 2005. They released a draft version to the public on February 26, 2007, and received comments from a diverse array of stakeholders—government, academia, public interest groups, and both large and small companies. In addition to considering the various comments, the EDF and DuPont conducted pilot-testing on surface-treated, high-rutile phase titanium dioxide (TiO2), single- and multiwalled CNTs, and nanosized zerovalent iron (nano-Fe°) “to ensure that [the framework] is flexible, practical, affordable, and effective.” 50 The final document issued today “offers guidance on the key questions an organization should consider in developing applications of nanomaterials, and on the information needed to make sound risk evaluations and risk-management decisions.” 50 The framework is intended to support ongoing regulatory initiatives, not replace them.
The EDF and DuPont believe that the framework, which is aimed primarily at organizations, both private and public, that are actively working with nanomaterials and developing associated products and applications, will help users organize and evaluate currently available information; assess, prioritize, and address data needs; and communicate clearly how risks are being mitigated. Ultimately, the EDF and DuPont “believe that the adoption of the Framework can promote responsible development of nanotechnology products, facilitate public acceptance, and support the formulation of a practical model for reasonable government policy on nanotechnology safety.” 50
The framework consists of six distinct steps and is intended to be used iteratively as stages of development advance and new information becomes available. The six steps are as follows:
Step 1: describe material and application. The first step is to develop a general description of the nanomaterial and its intended uses, based on information in the possession of the developer or in the literature. The user also identifies analogous materials and applications that may help fill data gaps in this and other steps.
Step 2: profile life cycle(s). Step 2 defines a process to develop three sets of profiles: the nanomaterial's properties, its inherent hazards, and associated exposures throughout the life cycle. The user considers the nanomaterial's full life cycle, from material sourcing, through production and use, to end-of-life disposal or recycling. The user considers how the material's properties, hazards, and exposures may change during that life cycle.
Step 3: evaluate risks. In this step, all of the information generated in the profiles is reviewed to identify and characterize the nature, magnitude, and probability of risks presented by the nanomaterial and its anticipated application. The user considers gaps in the life-cycle profiles, prioritizes those gaps, and determines how to address them, either by generating data or by using, in place of such data, “reasonable worst case” assumptions or values.
Step 4: assess risk management. In the fourth step, the user evaluates the available options for managing the risks identified in step 3 and recommends a course of action. Options include engineering controls, personal protective equipment, risk communication, and product or process modifications.
Step 5: decide, document, and act. In step 5, the user consults with the appropriate review team and decides whether or in what capacity to continue development and production. Consistent with transparent decision making, the user documents those decisions and their rationale and shares appropriate information with the relevant internal and external stakeholders. A worksheet is provided in the appendix for documenting information, assumptions, and decisions. 51
Step 6: review and adapt. Through regularly scheduled and triggered reviews, the user updates and reexecutes the risk evaluation, ensures that risk management systems are working as expected, and adapts those systems in the face of new information or new conditions. Reviews may be prompted by development milestones, changes in production or use, or new hazard or exposure data. As in step 5, the user not only documents changes, decisions, and actions but also shares appropriate information with relevant stakeholders.
A second initiative that is credible and well thought out is the Responsible NanoCode. 52 Britain's Royal Society, the Nanotechnology Industries Association, Insight Investment, and the UK government-sponsored Nanotechnology Knowledge Transfer Network collaborated on the proposed code. The objective of this “principles-based” voluntary code of conduct is to encourage industries, retailers, universities, research institutes, and other public or privately funded bodies involved in developing, manufacturing, and selling products of nanotechnology to adhere to seven principles to demonstrate responsible governance. The seven principles are as follows:
Principle One — Each organization should ensure that responsibility for guiding and managing its involvement with nanotechnologies resides with the Board or governing body. Principle Two — Each organization should proactively engage with its stakeholders and be responsive to their views in its development or use of products using nanotechnologies. Principle Three — Each organization should identify and minimize sources of risk for workers handling products using nanotechnologies, at all stages in the production process or in industrial use, to ensure high standards of occupational health and safety. Principle Four — Each organization should carry out thorough risk assessments and minimize any potential public health, safety, and environmental risks relating to its products using nanotechnologies. Principle Five — Each organization should consider and respond to any social and ethical implications and impacts during the development or sale of products using nanotechnologies. Principle Six — Each organization should adopt responsible practice in the sales and marketing of products using nanotechnologies. Principle Seven — Each organization should engage with suppliers and/or business partners to encourage and stimulate their adoption of the Code and so ensure its own ability to fulfill its Code commitments.
Code proponents launched a consultation period in the United States on October 9, 2007, which ended on November 12, 2007. On May 13, 2008, the Working Group of the Responsible Nano Code signed off on the code. 53
A third private sector initiative is the GoodNanoGuide, a collaboration platform designed to enhance the ability of experts to exchange ideas on how best to manage nanomaterials in occupational settings. 54 The GoodNanoGuide's beta sponsors include the NIOSH, International Council on Nanotechnology (ICON), Nanotech BC, Nano Alberta, Health Canada, Nano Quebec, and IRSST (a scientific research organization in Quebec). The GoodNanoGuide has three goals: develop and launch a protected Internet site on occupational practices for the safe handling of nanomaterials using a Wiki software platform; create a process wherein multiple stakeholders within the international community contribute, share, and discuss information related to occupational safety; and establish a modern, interactive forum that fills the need for up-to-date information and remains current as new practices develop.
Although the GoodNanoGuide reflects the global dialogue under way regarding the effect that nanotechnologies may have on human health, the environment, and society in general, the GoodNanoGuide is not meant to address or resolve such issues. Instead, according to the ICON, “it assumes that someone, somewhere in the world is likely to be working on nanomaterials as this debate continues, and thus endeavors to provide information to that person about current good practices to make sure appropriate safeguards are in place as that person works on nanomaterials in an occupational setting.” 55
Finally, the GoodNanoGuide is open for everyone to review. To ensure the dependability of the good practices reported, the GoodNanoGuide is a protected site in which contributions are limited to those individuals who have become GoodNanoGuide members.
Conclusion
As with the other commercial, legal, and governance issues, businesses engaged in the production and use of nanoscale materials must look to existing laws and regulations, voluntary and stewardship initiatives, and best industry practices to avoid liability. At the same time, these entities must discover new ways to proceed in an arena where the state of knowledge is still catching up to entrepreneurial initiatives.
Footnotes
Acknowledgment
Financial disclosure of author and reviewers: None reported.
*
Toxicology studies of certain ultrafine particles demonstrate that smaller particles have the potential to induce oxidative stress and inflammation in the respiratory tract and cardiovascular systems.
†
EPA is considering two general types of approaches to increasing public availability of inert ingredient identities. One would mandate disclosure only of potentially hazardous ingredients, and the other would promote or mandate public availability of most or all inert ingredient identities, regardless of hazard.
‡
These include up to 2 hours of confidential consultation with a national law firm with expertise in nanotechnology to assist with appropriate risk-allocating contract language, product labeling, product warranties, development and/or review of a nanotechnology risk management program, and/or participation in the EPA Nanoscale Materials Stewardship Program; up to 2 hours of outside technical consulting services in the areas of toxicology or EHS to help with developing, implementing, or assessing a nanotechnology risk management program; and on-site loss control consultations specific to mitigating hazards of nanomaterials used in the manufacturing process or included in the product.
§
The Workgroup is divided into four subgroups. It includes individuals with expertise in chemistry, environmental law and policy, toxicology, exposure and risk assessment, and other areas. The Workgroup has focused particularly on the potential exposure and hazards of nanoscale pesticides and how these concerns may or may not be addressed by traditional testing paradigms and risk assessment approaches.
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The recommendations call for Cambridge to take the following steps: establish an inventory of facilities that manufacture, process, handle, or store engineered nanoscale materials; offer technical assistance to help firms and institutions evaluate their existing health and safety plans; offer up-to-date health information to residents on products containing nanomaterials; track rapidly changing developments in research; track the evolving status of regulations and best practices concerning engineered nanoscale materials; and report back to the City Council every other year on the changing regulatory and safety landscape.