Nanotechnology Regulation Implementation in Industry

A.A. Taylor, E.L. Freeman
Exponent, Inc.,
United States

Keywords: TSCA, SNUR, risk assessment, toxicity, chemicals of concern

Summary:

Nanotechnology is a fast growing industry with increasing applications in consumer, industrial, pharmaceutical, and personal care products. One issue facing the nanotechnology sector is that current chemical regulations focus on single chemical substances and do not consider nanomaterials produced from the same materials as unique or separate materials. As such, nanomaterials manufactured from these various substances are approved for use under current regulations. However, because nanomaterials have unique properties when compared to the nonnanomaterial substance, governments are now evaluating special regulations for nanomaterial use. Regulatory agencies have been or will be collecting more data on nanomaterial uses, exposure and toxicity than ever before. With new rapid screening methodologies paired with toxicity assays that allow for testing of environmentally relevant exposure pathways and doses, data collected will help regulatory agencies to enact policies based on the best scientific data available for developing safety measures in industry. Historically, nanomaterial regulations have largely been left for the state or the industry to develop; much focus globally has been on defining the term “nanomaterial”. Some regulation does exist for worker protection; initial guidelines have been developed for worker safety via NIOSH and OSHA. Regulations governing nanomaterials will be evolving over the next several years, the summaries below give a snapshot of this process in its early stages. A recent update to nanotechnology regulation by the US EPA involves a Significant New Use Rule (SNUR) for nanomaterials. Based on the rule, persons who intend to manufacture, import, or process nanomaterials based on chemical substances already listed in the TSCA (Toxic Substances Control Act) Inventory must submit a Significant New Use Notice (SNUN) to EPA at least 90 days before commencing that activity. This rule provides EPA with basic information on the nanomaterial, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, and exposure, fate, and toxicity data. This information allows EPA to evaluate intended uses of these nanomaterials and to take action to prohibit or limit activities that present unreasonable risks to human or environmental health. In September 2016, the Minnesota Department of Health updated its list of chemicals of high concern to include carbon nanotubes and multi-walled carbon nanotubes. The update was based upon the International Agency of Research on Cancer’s 2014 listing of carbon nanotubes and multi-walled carbon nanotubes as possible human carcinogens. As of October 27, 2017, EPA has also proposed generation of a SNUR for functionalized carbon nanotubes. To prepare for new regulations, the nano-based industry needs to be aware of emerging regulations and assess the impact on current and planned products. Future commercialization of nano-products must consider the following: knowledge of the supply chain and life cycle of the products, identification of unique properties, and assessment of the potential for human and ecological toxicity.