Regulatory Definitions of ‘Nanomaterials’

In 2004, the UK Royal Society and the Royal Academy of Engineering published perhaps the first widely respected and cited assessment of the potential health and safety, environmental, and ethical implications of nanotechnologies and the use of nanomaterials.  The report highlighted the enormous potential societal benefits from nanotechnologies and nanomaterials in areas such as electronics, health care, aerospace, defense, automotive, packaging and environmental remediation.  It also underscored the poorly understood environmental, health and safety risks of these advanced materials, and the particular challenges in assessing them. It called on industry and governments to take steps to ensure the responsible commercial development and deployment of nanomaterials, including adaptation of existing environmental, health and safety regulation as warranted to address the particular character of nanomaterials. The Royal Society’s recommendations launched what is now nearly a decade of frenzied study and debate, from all corners of civil society, concerning the health risks of nanomaterials and their proper governance.

Determining how nanomaterials as a class should or shouldn’t be regulated is particularly challenging for several reasons.  The first and most significant is that they are all quite different from one another – different substances; different shapes, sizes, structures and aggregation states; different manufacturing methods; different uses; different risks. Second, while it is well understood that the increased surface area and small size of nanomaterials (billionths of a meter) can radically change their mobility, reactivity, strength and electrical properties – and produce quantum effects altering optical, electrical and magnetic properties – it is not well understood how to predict these changes in individual materials, or to predict their implications for health in any exposed workers and consumers. Third, governments’ dual responsibilities to both protect public health and to promote economic stability and growth creates significant tension between offices (sometimes within a single agency) that wish to exploit nanotechnologies to further their missions (e.g., defense, energy, trade) and those charged with environmental, worker, consumer and patient safety. Both want to exercise sufficient care in the development and use of these technologies, but may have different perspectives on where to draw the line.

In the US, the Office of Management and Budget (OMB) created the Emerging Technologies Interagency Policy Coordination Committee as a forum to mediate these tensions among agencies. This committee was able to agree on and publish a set of principles for regulation of nanotechnologies earlier this year, but significant practical tensions remain. This is evidenced by several Environmental Protection Agency (EPA) nanomaterial rules that remain under OMB review after many months. Nevertheless, regulatory action in individual cases is proceeding, albeit cautiously.  Our experience working with companies seeking required pre-market approvals from EPA for particular new nanomaterials and new uses of nanomaterials indicates both the EPA’s increasing sophistication with the issues, but continued deliberate decision making as each new case tends to establish new precedent and must be fully vetted.

The European Union took a very different approach last month when the European Commission (EC) adopted a formal definition of a “nanomaterial” to be used for regulatory purposes. This action was precipitated by a 2009 European Parliament resolution calling for a formal, “science-based” definition of “nanomaterials” that could be incorporated into all EU legislation and facilitate the prompt adoption of nano-specific regulations. Given the enormous variety of individual materials that might be considered nanomaterials, and the nearly equally broad variety of purposes for which they might be regulated or referred to in regulations (e.g., product or personal safety regulation, customs or tariff schedules, controlled materials for defense purposes, or specifications in research proposals), a single definition is very unlikely to meet everyone’s needs.

Recognizing this, the EC’s scientific committee that developed the recommended definition nominally aimed to provide a neutral, baseline definition based solely on size that could be adopted and modified to fit the specific purpose of each set of rules to which it was applied.  However, as adopted, the EC stated that the definition primarily should be used by government and industry to identify the subset of materials that should be given greater scrutiny in regulatory risk assessment and decision-making. “Nanomaterials” were defined as:

• Natural, incidental or manufactured material containing particles,
• Where the particles are in an unbound state or in an aggregate or agglomerate, and
• Where 50% or more of the particles in the material have one or more external dimensions in the size range 1 nm – 100 nm.
• The definition also includes fullerenes, graphene flakes and single wall carbon nanotubes, although they often exist in size ranges less than 1 nm.

While these criteria are clear and seemingly unambiguous, they are also arbitrary in relation to their stated purpose.  For example, while the definition has a clear size range cut off at the upper and lower ends, the Scientific Committee on Emerging and Newly Identified Health Risks states that this range was selected only as a matter of current common usage, and that, in fact, there is no evidence to say that particular materials in this range are likely to exhibit special properties, or that materials below or above this range do not exhibit special properties.  Similarly, the EC admits that there is no unequivocal scientific basis to conclude that only materials with 50% or more of their particles in the specified size range will present special properties or greater health risk. That value was selected arbitrarily over the equally unsubstantiated 1% or less values recommended by EC’s science advisers for practical reasons – the lower value would have brought too many different materials within the scope of the definition.

The reliance on the number size distribution as opposed to the more typical mass-based distribution is not neutral, but reflects an assumption and generalization about risk of smaller particles and is designed to bring more materials within the scope of the definition.  The definition is also flawed to the extent that it defines covered materials by size and size distribution, but does not specify how those will be measured.  For some particles, there will be multiple ways to measure size and distribution, and for others there will be none (e.g., smaller particles embedded in large particles); in either event inconsistent conclusions may be drawn.

In theory, the EU definition could be used properly for regulation – used as a baseline and modified to meet the needs of particular programs – but there is a significant risk that the arbitrary distinctions in the default definition will in fact be used as substantive criteria.  This would result in a both over and under inclusive definition and may cause materials that warrant further attention to be overlooked. It may also capture a wide range of common materials and articles (e.g., powder pigments, tires, and thin film surface coatings) that may not warrant any scrutiny as nanomaterials.  In the short term, this classification may only affect labeling of European cosmetics (which already require disclosure of “nanomaterial” ingredients) and European chemical safety evaluations under REACH.

The emerging EU experience is instructive for US policy as well. EPA is currently preparing two rules under the Toxic Substances Control Act likely to be applicable to some class of “nanomaterials” that EPA has yet to define. Currently under review at OMB, the first is an information collection rule that would require reporting to EPA of a wide range of production, exposure and health effects information for all covered “nanomaterials.”  The second would restrict use of all covered “nanomaterials” to their current uses. Companies would be prohibited from using covered “nanomaterials” for any “new” use until after preparing an extensive significant new use notice and allowing EPA 90 days or more to evaluate the potential risks, in which time, EPA might impose significant use and handling restrictions or testing obligations. All companies that deal in physical goods (or invest in them) will need to watch EPA’s development of these rules and be prepared to intervene where appropriate.

James G. Votaw is a counsel in the Energy, Environment and Natural Resources practice at Manatt, Phelps & Phillips, LLP, practicing in the Washington, D.C., office. He represents clients in a wide range of environmental defense, counseling, transactional and chemical regulatory matters, and has particular experience advising companies in manufacturing or using engineered nanomaterials. Mr. Votaw can be reached at [email protected] or 202.585.6610.

This column is the tenth in a series of articles by law firm Manatt, Phelps & Phillips, LLP’s Energy, Environment & Natural Resources practice. Earlier columns discussed Energy Efficiency Retrofits, California’s Cap and Trade program, Green Marketing Regulation, Corporate Sustainability, Green Chemistry Regulation, Renewable Project Failures in California, Promoting Recycled Water, Environmental Liabilities in Bankruptcy Reorganizations, and California Renewable Policy.