Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on “Moving Beyond Nanogeneralities -- Providing Focus to Nanopolicy Progress.” Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere, International Food Policy Research Institute. The speakers propose that the issues concerning nanotechnology and nanomaterials are so varied, broad, and controversial that they impeded the development of beneficial uses, even where the risks are negligible. The speakers suggest that, early in any discussion or in any risk assessment of nanomaterial uses, the problem selection and problem formulation are critical. If the selection and formulation are done well, regulators and stakeholders can make progress in risk assessment policy and risk management of specific uses of nanomaterials.

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On November 22, 2010, the U.S. Environmental Protection Agency (EPA) submitted a proposed Toxic Substances Control Act (TSCA) Section 8(a) reporting rule to the Office of Management and Budget (OMB) for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require persons who manufacture nanoscale materials notify EPA of certain information including available use, production volume, methods of manufacture and processing, exposure and release information, and available toxicity data pertinent to existing nanoscale materials. EPA states that the proposed reporting of these activities will provide it with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

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On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. Of particular note, CDTSC has removed all references to nanotechnology and nanomaterials in the proposed regulations, which previously defined nanomaterials and included “physical, chemical, or quantum properties specific to nanomaterials” on the list of prioritization factors that CDTSC would consider in placing chemicals on the list of Chemicals Under Consideration. The revised proposed regulations also no longer exclude nanomaterials from the de minimis exemption. Under the Green Chemistry Program, the Office of Environmental Health Hazard Assessment (OEHHA) will specify the hazard traits, environmental and toxicological end-points, and other relevant data to include in the state’s Toxics Information Clearinghouse. CDTSC will use information from the clearinghouse to help identify chemicals of concern in consumer products. OEHHA’s pre-regulatory draft regulation includes reference to nanoparticles and defines a “nanomaterial hazard trait.” Comments on CDTSC’s revised proposed regulations are due December 3, 2010.

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The U.S. Environmental Protection Agency (EPA) has posted a June 17, 2010, document entitled “Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials.” According to the Interim Guidance, EPA prepared it “to serve as a guide when developing screening level exposure and environmental fate and transport assessments for nanomaterials,” such as those submitted under the Toxic Substances Control Act (TSCA) New Chemicals Program.  The Interim Guidance is applicable for neat nanomaterials (i.e., powdered or particulate forms), as opposed to nanoscale particles embedded within composites.  At this time, according to the Interim Guidance, EPA does not have models or methods capable of predicting the fate of, or exposure to, nanoscale particulates in the environment.  This fact, combined with the limited data for nanomaterials, means that there is uncertainty in estimating removal efficiencies, degradation half-lives, partitioning, and transport of nanomaterials.  To address the uncertainty, EPA recommends using a conservative bounding “what if” scenario, which assumes that nanomaterials are not removed during wastewater treatment or incineration (i.e., 0 percent removal efficiency), are persistent (i.e., P3), are highly bioaccumulative (i.e., B3), and are highly mobile in groundwater unless measured data is available that proves otherwise.  EPA describes this conservative approach as “prudent at this time given the limited available data and lack of historical knowledge regarding the behavior of nanomaterials in the environment.”

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At the U.S. Department of Agriculture’s (USDA) National Organic Standards Board’s (NOSB) October 25-28, 2010, meeting, NOSB unanimously recommended that the USDA National Organic Program (NOP) prohibit engineered nanomaterials from certified organic products. NOSB considered a September 2, 2010, guidance document prepared by its Materials Committee concerning engineered nanomaterials in organic production, processing, and packaging. According to the Materials Committee, public comment “overwhelmingly agrees that nanotechnology in organic production and processing be prohibited at this time.” The Materials Committee notes, however, that “there is considerable debate and disagreement on what exactly nanotechnology is and what products of nanotechnology should be prohibited.”. The Materials Committee requested that the NOP allow NOSB to call for a symposium “to discuss the issues related to the human-engineered portion of this science,” which “would help to clarify these confusing issues, and serve to educate both the Board and the NOP on this topic.”

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On November 4, 2010, the Project on Emerging Nanotechnologies (PEN) released a report entitled Voluntary Initiatives, Regulation, and Nanotechnology Oversight: Charting a Path, which reviews a number of voluntary options available for the oversight of nanotechnology products and processes. The report classifies the various types of voluntary initiatives and the partnerships that underlie them, and assesses the factors that are most likely to contribute to program success. The thesis of the report is that both non-regulatory and voluntary initiatives can play a constructive role in nanotechnology oversight. The report concludes that as nanotechnologies move forward, voluntary programs will play an important role in the governance portfolio available to the federal government, as well as states and municipalities.

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The National Nanotechnology Initiative (NNI) draft Strategic Plan is available for comment until November 30, 2010. The Strategic Plan is the framework that underpins the work of the 25 NNI member agencies.  The Strategic Plan is intended to ensure that advances in nanotechnology research and development (R&D) and their applications to agency missions and the broader national interest continue. The purpose of the Strategic Plan is to facilitate achievement of the NNI vision by providing guidance for agency leaders, program managers, and the research community regarding planning and implementation of nanotechnology R&D investments and activities.

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The National Institute for Occupational Safety and Health (NIOSH) has posted an October 2010 Impact Sheet entitled “NIOSH Research Methods Demonstrate that Breathing Nanoparticles May Result in Damaging Health Effects,” which reports the results of recently published research concerning the health effects of inhaling single-walled carbon nanotubes. According to the Impact Sheet, NIOSH scientists invented a way to suspend nanotubes in air, thus allowing for control of the concentration of particles, unlike previous studies, which dosed the mice through aspiration. NIOSH scientists placed the mice into a controlled environment where they would breathe the air containing the particles, and studied the effects of exposure after one, seven, and 28 days.  The Impact Sheet states that, although the effects were similar, the new results “demonstrated that carbon nanotubes were more potent when inhaled than when aspirated.”  According to NIOSH, “this research has shown early indications of serious health outcomes that may have longer term effects such as cancer, and therefore, ongoing research is important to more clearly understand the implications of exposure to carbon nanotubes.  This study and continued NIOSH research could soon help the development of occupational safety and health recommendations for carbon nanotubes that will protect the health of nanotechnology workers.”

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