December 1, 2011
The primary regulatory focus for nanomaterials involves human health and environmental concerns. To date, efforts to deal with nanomaterials have been patchwork attempts as government agencies and regulators have struggled to expand existing regulatory frameworks to cover nanomaterials.
Current FrameworkIn the U.S., the regulation of nanomaterials occurs primarily at the federal level among various federal agencies. The Environmental Protection Agency (EPA); the Occupational Safety and Health Administration (OSHA); the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention; and the Federal Drug Administration (FDA) all have a role with respect to nanomaterials. For example, the EPA has addressed multi-walled carbon nanotubes by issuing a Significant New Use Rule under the Toxic Substances Control Act (TSCA), and has addressed nanosilver through the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). However, those regulatory efforts remain in the preliminary stages.
Most of the discussion regarding regulating nanomaterials focuses on future action. There has been much discussion in the U.S. about the need to amend TSCA. It is anticipated that any revisions to TSCA would more specifically address and encompass nanomaterials. In addition, several states are also considering enacting their own regulations regarding the use and safe handling of nanomaterials. California, in particular, is looking at regulating nanomaterials as part of its Green Chemistry Safer Alternatives regulation.
Outside the U.S., the primary regulatory driver is the European Union, where the main regulation addressing chemical substances is the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Although not specifically enacted to address nanomaterials, REACH embodies many of the regulatory trends that are anticipated to apply to nanomaterials in the future.
Within the European Union, there is currently a debate as to whether REACH, in its present form, is sufficient to cover nanomaterials or whether it needs to be amended to more specifically address them. The primary issue is that REACH generally only applies to chemical substances manufactured or used in excess of one metric ton per year. Current guidance is that REACH, as written, does cover nanomaterials to the extent that their manufacture or use within the European Union exceeds the one metric ton limitation, thus requiring that such substances will need to be registered and safe use information provided. However, because of the miniscule nature of nanomaterials, there is concern in particular from certain European Union member states and the non-government organization (NGO) community that the one metric ton limit is much too high for nanomaterials. As a result, the European Commission has identified this as an issue to be addressed with respect to the potential amendment of REACH.
Future TrendsAny discussion regarding the future regulation of nanomaterials inevitably stalls at how nanomaterials are going to be defined. While one might think that this would be a relatively simple challenge for legislators who are used to developing definitions, it has proven to be a significant stumbling block. For example, the European Union has been working to develop a common definition of nanomaterials for years. In 2009, the European Parliament issued a resolution calling for the development of such a definition. It is expected that a non-binding definition will be finally articulated by the European Commission this year. It is hoped that the definition will create a common understanding and be used in a number of different regulations.
Most trends discussed with respect to nanomaterials are part of the broader debate on regulating chemicals. This broader debate can be seen most clearly in the discussions regarding amending TSCA. For example, a key issue is whether to adopt the precautionary principle in place of the current approach, which generally calls for regulation of a substance only if a hazard has been specifically identified. Additional trends include the call for greater public discourse and involvement in the regulations, the increased need for research and the open sharing of the results, the minimization of the ability to claim information as confidential or trade secret, the increased expectation that companies manufacturing or using the same materials will share information despite antitrust concerns, and the need to have the regulatory framework be more flexible and agile to allow regulators to address new or perceived risks in a more expeditious fashion.
The Principles for Regulation and Oversight of Emerging Technologies recently adopted by the U.S. echo these trends. These principles include scientific integrity, public participation, communication, benefits and costs, flexibility, risk assessment and risk management, coordination, international cooperation, and adherence to certain other existing regulations.
Applying these general trends to the unique considerations posed by nanomaterials provides a glimpse of future regulations. For example, current regulations of chemical substances are generally based on familiar concepts of dose and length of exposure, resulting in occupational exposure limits. Many in the scientific community anticipate that the current occupational exposure limits that apply to large-scale substances will be insufficient to protect against exposure to the nanoscale versions of those substances. An example of this is carbon. This is of particular concern because scientists believe that certain nanomaterials have the potential to cross biological barriers more effectively than larger particles.
This belief also raises the question of whether new mechanisms of toxicity may be discovered that would then lead to additional regulatory measures. Future regulations are likely to require longer term studies of the various nanomaterials to determine their safety, especially as it relates to different uses and the effectiveness of protective measures. Some of the studies may have to consider the entire lifecycle of the material. Those entities conducting these studies will face enhanced expectations to disclose the results regardless of confidentiality concerns. In addition, because of the increasing involvement of the public in the regulatory process, these studies will likely face enhanced scrutiny and challenges from outside the scientific community based on perceived risks.
An important consideration when determining the potential health and safety impact of a nanomaterial is the particle size, shape, and bundling. These variations in properties may impact the toxicity of that particular nanoform. Thus, exposure limits should be specific to the particular nanoform, to the extent practicable. Finding the applicable level of regulatory specificity will be a challenge. If the particular nanomaterial is defined too broadly, any required protective measures will likely be both over- and under-protective. In contrast, if the particular nanomaterial is defined too narrowly, the costs of the necessary testing and the required disclosures of what may generally be considered proprietary information (e.g., details of particle dimension, manufacturing process, uses, etc.) may be unacceptable to the business community.
Another current difficulty has been the availability of tools and techniques for measuring and monitoring exposures. Existing regulations, as well as those to be implemented in the very near term, will necessarily be limited to standards using existing equipment and means of measurement. As better means of determining and measuring exposure are developed and gain acceptance within the scientific community, regulations will be revised to incorporate the use of such means.
Regulations designed to cover exposures in the workplace are likely to focus on hazard communication (including safety data sheets) and employee notification; worker training and safe work practices; and exposure analysis, monitoring and prevention. An existing regulation that could be currently applied to nanomaterials is OSHA’s General Duty Clause, which requires an employer to provide its personnel with employment that is free from recognized hazards that are causing or likely to cause death or serious physical harm.
It is expected, however, that future regulations will provide more specificity for these requirements. For example, future regulations may specify the exact nature of the hazards and prescribe particular wording for hazard communications and employee notifications. Specific occupational exposure limits may be enacted, along with prescribed monitoring activities and their frequency requirements.
For more information, contact Vorys, Sater, Seymour and Pease at (614) 464-6400 or visit www.vorys.com.
SIDEBAR: Answers NeededThe future regulatory framework for nanomaterials will ultimately be determined based on the answers to these questions:
- Can a sufficient common definition of nanomaterials be developed and adopted?
- Will the international community be able to develop a consistent coherent set of regulations, or will the regulatory framework develop in a patchwork of regulations by different countries and different agencies?
- Will new regulations be developed specifically to deal with nanomaterials, or will the existing regulatory framework just be stretched to cover these materials?
- Will the regulations adopt the principles advanced by the European Union as evidenced in REACH, as opposed to the traditional principles that formed the basis for TSCA and other existing regulations?
- Will regulators continue to discuss nanomaterials as a whole, rather than recognizing the incredible and complex diversity of materials that fall within that definition?