Nanotechnology Regulation – EPA Developing Rule to Regulate All New Uses of Engineered Nanoscale Materials
For nearly a decade, the U.S. Environmental Protection Agency (EPA) has been considering how and to what extent to regulate the environmental health and safety aspects of nanoscale materials within the framework of existing laws. EPA now appears primed to propose an information collection and use pre-authorization review rule applicable to all nanomaterials as a class.
To now, EPA nanomaterial regulation has been conducted on a case-by-case, chemical-by-chemical basis as particular nanomaterials have come to market and triggered regulatory reviews under existing law applicable to any chemical. Most regulatory action to date has been conducted under 1976 Toxic Substances Control Act (TSCA), a key oversight statute that authorizes EPA to review and, if appropriate, to regulate the lifecycle risks of new chemicals, and to regulate by rule significant new uses of existing chemicals (called ‘significant new use rules’ or SNURs).
This kind of case-by-case, risk-based regulation — based on scientific evidence of specific risks in the context in which the identified risks may be expected to arise rather than unsupported generalizations — permits agencies to tailor regulation to the plausible risks presented. Such science-based approaches promote balanced regulation that protects human health and the environment without creating unnecessary barriers to innovation and trade.
Risk-based regulation principles should preclude responsible attempts to regulate “nanomaterials” as a single class. While standards organizations and governments have made various attempts to develop a single, common definition of “nanomaterial” for regulatory purposes, the fact is that nanomaterials, like chemical compounds generally, represent an infinite variety of chemical combinations, present in the world in an infinite variety of shapes, compositions, aggregation states and mixtures, and used in an infinite variety of commercial contexts, all of which can be expected to present different hazards and risks. The only characteristic they may have in common is size range, and that characteristic does not consistently correlate to heightened hazard or risk.
EPA’s Omnibus Nanomaterial Regulation in Development
Nevertheless, in 2009, EPA began work on a TSCA regulation that would be applicable to all nanoscale materials. The working text of the rule has not been publicly released, but EPA’s description of the regulation in the Unified Regulatory Agenda explains that it would have two components: a Significant New Use Rule and an information reporting rule.
Nanomaterial Significant New Use Rule. As described, the anticipated SNUR would be applicable to any use of a nanoscale material, except commercial applications already in use at the time that the rule is proposed. Such ‘grandfathered’ uses would be exempt from most requirements. For new uses, the rule would require importers, manufacturers, and processors to submit a dossier (a “significant new use notice” or “SNUN”) to EPA detailing how the nanomaterial substance would be manufactured and used by the proponent and its downstream customers. The SNUN would have to be submitted at least 90 days prior to any new use of a nanomaterial. EPA would conduct a risk assessment of that use, and could then choose to ban or restrict the use under an order, or compel testing. The user would be obligated to notify EPA before exporting the material, and required to keep records. Based recent EPA SNURs for new nanomaterials, the restriction might tightly bind the user to a particular use of the material, restrict the user to material made by a particular manufacturer, and require a submission of a new SNUN and new 90-day review period if there were any changes. These operational constraints could be made to apply to grandfathered uses as well. The SNUR might also require the user to have its customers enter into a parallel order with EPA, at least for 12 or 18 months until EPA issued a regulation imposing those restrictions.
Nanomaterial Information Collection Rule. Coupled with the nanomaterial SNUR, EPA is also poised to issue a TSCA §8(a) information collection rule applicable to all existing nanoscale materials. EPA has great flexibility is determine the extent of the information to be collected on manufacturing, processing, use and exposure. In this case, it appears EPA anticipates very significant information collection efforts by industry as it estimates each response will require nearly 160 man hours to complete. EPA would use that information to identify existing uses that may present risks warranting future EPA regulation.
EPA also would use the information responses to inventory all existing commercial uses of nanomaterials. Any use not identified in the ‘inventory’ presumably would be deemed to be a “new use” and prohibited unless first notified to EPA under the nanomaterial SNUR. And while small entities usually are exempt from such information collection rules, that exemption does not necessarily apply when coupled with a SNUR. TSCA §8(a)(3(A).
Concerns with the Anticipated Rule
Unfortunately, this kind of heavy, up-front regulation may be likely to dissuade all but the most committed niche users from developing new uses for nanomaterials, and make those uses more costly. It likely would be difficult for new market entrants even to identify the particular chemical-specific uses EPA had reviewed or otherwise deemed to be existing.
The burden on innovation might be worth the cost if there were specific reason, based on scientific evidence, to believe that a particular new use of a particular nanomaterial might plausibly present an unreasonable risk, but EPA’s anticipated approach would not be based on that kind of analysis. It appears that EPA will rely on some non-specific generalization about “nanomaterial” risks to require all nanomaterials uses to proceed through the review process. Although administratively convenient for EPA, this would be inconsistent with good risk-based decision making practice and likely improper under TSCA, which requires EPA to assess all relevant factors, including a number of specific factors for which there is no basis to generalize across all nanomaterials.
Current Status of the Nanomaterial Information Collection Rule and SNUR
The combined rule has been delayed, but the circumstances suggest it may be ready for proposal early next year. EPA submitted a draft of the proposed rule to the Office of Management and Budget (OMB) in the White House for review in late 2010, but it has not yet been returned. While such a long review is unusual, EPA sources confirm that discussions between EPA and OMB are continuing. In the meantime, the Obama administration developed guidelines for U.S. agencies to follow in regulating nanomaterials, and late this year will reach the conclusion of an 18-month effort to develop with Canada, among other things, a consensus framework for regulating the environmental safety and health aspects of nanomaterials. The U.S.-Canada Regulatory Cooperation Council (RCC) also will produce consensus reports on nanomaterials in commerce and their uses, classifying industrial nanomaterials, and best practices for nanomaterial risk assessments and management; precisely the kind of robust record information EPA could use to support an information collection rule and SNUR.
While the timeline remains uncertain, an omnibus nanomaterial information collection rule and SNUR proposal appears to be on the horizon. Companies need to prepare to assure that they can identify the nanomaterial uses in their products and processes. A very significant open issue is how EPA will define the particular materials covered by the rule, including the extent to which EPA may distinguish between naturally occurring, engineered and by-product nanoscale materials, the treatment of aggregates and agglomerates of primary particles, or particles combined in solid or liquid mixtures, and whether or not novel, size-related properties will be considered. Assuming a relevant size range could be selected, even defining size of a material will be difficult for several reasons. First, even homogenous particulate materials typically exist over a range of sizes and can only really be measured as a relative size distribution. And distributions can be measured by mass or particle number. Second, through various processes, particles will change size over their production and use lifecycle, e.g., by aggregation, or may form spontaneously from ions or chemical changes in other particles. Third, particularly at this scale, different measurement methods are likely to generate different results for the same material. Indeed, there may not be effective methods even to measure certain particles reliably (e.g., those distributed in another solid or liquid matrix.
In addition to these important technical issues, companies also need to be ready to take a step back and identify the broad societal and operational concerns raised by an omnibus SNUR regulatory model for nanomaterials. Affected companies and industries must be prepared to inform EPA about the practical implications and difficulties with this kind of an approach, and to offer practicable alternatives.
James G. Votaw is a partner in the Washington, D.C. office of Manatt, Phelps & Phillips, LLP. His practice focuses on conventional, nanoscale, industrial, pesticidal and specialty chemical product regulation, policy and approval matters; environmental, health and safety law compliance auditing and enforcement defense, and associated business counseling and litigation issues. Mr. Votaw can be reached at (202) 585-6610 or firstname.lastname@example.org.
This column is part of a series of articles by law firm Manatt, Phelps & Phillips, LLP’s Energy, Environment & Natural Resources practice. Earlier columns in the third edition of this series discussed Federal Chemical Regulation Reform, Efforts to Address Climate Change and What the Sequester Means for Environmental Regulation.
 See, e.g., European Union Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR), Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials (Jun. 2010).
 RIN 2070-AJ67
 See, e.g. RIN 2020-AJ54
 Policy Principles for US Decision-Making Concerning the Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, J. Holdren, Director, Office of Science And Technology Policy, C. Sunstein, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget and I. Siddiqui, Chief Agricultural Negotiator, Office of the US Trade Representative (Jun. 2011).
 The RCC has a two year mandate to increase regulatory alignment between the counties, promote smarter, less burdensome regulations in specific sectors, including nanotechnology. http://www.trade.gov/RCC/
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