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

The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach.  The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop.

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The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments.  The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.”  Comments are due March 31, 2012.

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President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from the United States Department of Agriculture (USDA), has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products.

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On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.”

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During the Summit on the Global Agenda 2011, the World Economic Forum’s Global Agenda Council on Emerging Technologies asked members to identify the technology trends that would have the greatest global impact. The trends, which were presented in order of greatest potential to provide solutions to global challenges, include “nanoscale design of materials” as fourth on the list. According to the Council, “increasing demand on natural resources requires unprecedented gains in efficiency. Nanostructured materials with tailored properties, designed and engineered at the molecular scale, are already showing novel and unique features that will usher in the next clean energy revolution, reduce our dependence on depleting natural resources, and increase atom-efficiency manufacturing and processing.” Nanotechnology was also mentioned in other trends: Number 6, “Utilization of carbon dioxide as a resource” (“[n]ovel catalysts, based on nanostructured materials, can potentially transform carbon dioxide to high value hydrocarbons and other carbon-containing molecules”); Number 8, “High energy density power systems” (“emerging technologies are coming together to lay the foundation for advanced electrical energy storage and use, including the development of nanostructured electrodes, solid electrolysis and rapid-power delivery from novel supercapacitors based on carbon-based nanomaterials”); and Number 9, “Personalized medicine, nutrition and disease prevention” (emerging technologies, including nanotechnology, “are laying the foundation for a revolution in healthcare and well-being that will be less resource intensive and more targeted to individual needs”).

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The U.S. Environmental Protection Agency (EPA) announced in a February 13, 2012, Federal Register notice the availability of its Fall 2011 Regulatory Agenda. EPA’s Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in March 2012.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intends to publish an NPRM in March 2012.

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On February 17, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson will tour the Center for Environmental Implications of Nanotechnology (CEIN) at the University of California, Los Angeles. CEIN has been awarded a $24 million grant from EPA and the National Science Foundation, and is working to train the next generation of nano-scale scientists and engineers. According to EPA, CEIN is one of the nation’s only centers researching predictive toxicology of nanomaterials, and is developing a new approach to identify impacts and environmental hazards of nanomaterials before they become widely used in the environment. CEIN was established in September 2008 with the mission to ensure that nanotechnology is introduced in a responsible and environmentally compatible manner, thereby allowing the U.S. and international communities to leverage the benefits of nanotechnology for global economic and social benefit. CEIN is accomplishing this mission by developing a broad-based series of decision tools based on models of predictive toxicology and risk ranking premised on selected nanomaterial property-activity relationships that determine fate, transport, exposure, and biological injury mechanisms at cellular, tissue, organism, and population levels.

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The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:

• REACH does not define nanomaterials, and contains no nano-specific provisions;
• Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
• REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
• REACH test guidelines fail to consider the special properties of nanomaterials.

CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”

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On February 9, 2012, the U.S. Environmental Protection Agency (EPA) posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the National Center for Environmental Assessment (NCEA) to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials.  The basis of the workshop was the report Nanomaterial Case Study:  Nanoscale Silver in Disinfectant Spray.  According to the summary report, the outcomes of this and future workshops in the series -- prioritized information gaps and risk tradeoffs -- will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.

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The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products. To do this, the Project will: (1) examine full life cycles of nanomaterials in products; (2) work through specific release scenarios at key exposure points of the life cycle; (3) organize existing material characteristics data and measurement methods for those release scenarios; (4) develop a “state of the science” report for release measurement; and (5) carry out inter-laboratory testing to promote improvements, standardization, and widespread use of methods. The NanoRelease Project completed Phase 1 in 2011, resulting in the selection of multi-walled carbon nanotubes (MWCNT) in polymers as the first material to be evaluated through inter-laboratory studies of methods. In Phase 2, three Task Groups of more than 40 experts are evaluating: (1) measurement methods; (2) the effect of materials selected on release rates; and (3) identifying the key exposure/release scenarios. Each Task Group will produce a white paper on their respective topic. Phase 3 is scheduled to begin in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of MWCNT released from selected polymers. The NanoRelease Project is organized by Dr. Richard Canady of the ILSI Research Foundation, and is supported by the U.S. Environmental Protection Agency, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute.

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