On January 22, 2009, the California Department of Toxic Substances Control (DTSC) issued a “chemical information call-in,” broadly requiring carbon nanotube (CNT) manufacturers and importers to submit data “regarding analytical test methods, fate and transport in the environment, and other relevant information.”1 Meanwhile, the Canadian government is reportedly poised to implement regulations requiring businesses to disclose information about the use and risks of engineered nanomaterials in their products. These developments confirm that businesses manufacturing or using nanomaterials generally — and carbon nanotubes specifically — should anticipate and begin preparing for escalating regulatory scrutiny.
California DTSC’s “Chemical Information Call-In”
Premised on DTSC’s regulatory authority under the California Health and Safety Code, the chemical information call-in is purportedly necessary to “help develop the existing body of information on carbon nanotubes needed to better protect human health and the environment.” DTSC’s notice cites two recent studies as evidence that “data on [CNT-related] analytical methods, toxicity, physicochemical properties, and fate and transport” remain inadequate despite the widespread commercial availability of CNTs. The first study, conducted at the Massachusetts Institute of Technology, detected the release of various aromatic hydrocarbons (including PAHs) during CNT manufacturing operations. The second study, from the Georgia Institute of Technology, suggests that “CNTs spilled into groundwater” could potentially enter public drinking water supplies.
As used in DTSC’s call-in notice, the term “manufacturers” broadly includes “persons and businesses that produce carbon nanotubes in California or import carbon nanotubes into California for sale,” as well as “academic institutions doing CNT research.” The list of notice recipients includes several entities in California and other entities outside the state, and could be expanded in the near future.2
Recipients must provide the following information to DTSC within one year:
- What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?
- What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.
- What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use and end-of-life disposal?
- What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?
- What methods are you using to protect workers in the research, development and manufacturing environment?
- When released, does your material constitute a hazardous waste under California Health and Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded, are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?
These requests clearly pose potential problems for current and future call-in notice recipients. Setting aside the time and expense of responding to DTSC’s notice, CNT manufacturers should think carefully about how information submitted in response may impact future regulatory action in California and elsewhere. Moreover, documents and information submitted at this early regulatory juncture could have significant implications for future toxic tort claims and environmental litigation.
Forthcoming Canadian Regulation
Meanwhile, the Project on Emerging Nanotechnologies (PEN) reported on January 28, 2009, that Canada will soon implement the world’s first mandatory nanotechnology reporting requirements at a national level.3 Canada “is reportedly planning in February to become the first nation in the world to require companies to detail their use of engineered nanomaterials.”4 The Canadian regulations will apparently “target companies and institutions that manufactured or imported a total quantity greater than 1 kg of a nanomaterial during the 2008 calendar year.”5 While it is presently unclear what chemicals might fall within the definition of “nanomaterials” or what information businesses may be required to submit under the new regulations, the anticipated rules will constitute a first step toward the development of a comprehensive framework for regulating nanomaterials in Canada.
What’s Next in the United States?
While it remains to be seen how federal oversight of nanotechnology’s reported environmental and health risks will develop under the Obama administration and a Democrat-controlled Congress, recent signs point to growing interest in nano-specific regulations at the national level in the United States. In October 2008, for example, EPA indicated carbon nanotubes may be considered new chemical substances — and thus subject to onerous reporting requirements — under the federal Toxic Substances Control Act (TSCA). See 73 Fed. Reg. 64,946. EPA has also taken preliminary steps to regulate certain silica and alumina nanoparticles as significant new uses under TSCA, and recently solicited public comments on the potential regulation of all nanosilver-containing products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). See 73 Fed. Reg. 65,743, 65,763; 73 Fed. Reg. 69,644. Coupled with these developments, the new activity in California and Canada may foreshadow increasing U.S. federal interest in nanotech regulation, as well.