California has always been in the vanguard on emerging issues in health and safety, and nanotechnology is no exception. In 2006, sections 57018, 57019 and 57020 of the state’s health and safety code were amended to empower state agencies in California to request information about chemicals from manufacturers. As a result of the amendments to the health and safety code, California’s Department of Toxic Substances Control (DTSC) has engaged in two separate call-ins designed to gather information about nanoparticles. The first call-in, which took place from January, 2009 through January, 2010, sought information from manufacturers about carbon nanotubes. The second, which runs from December, 2010 through December, 2011, seeks information from manufacturers about Nano Silver, Nano Zero Valent Iron, Nano Titanium Dioxide, Nano Zinc Oxide, Nano Cerium Oxide, and Quantum Dots. Both call-ins are mandatory in nature; manufacturers cannot opt out of providing a response.
For the carbon nanotubes call-in, the DTSC sent a letter to manufacturers, which sought the following information:
- 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 &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?
The nanometal oxides and quantum dots information requests sent out by DTSC were more formalized and were included in a questionnaire sent directly to manufacturers. Specifically, DTSC “seeks information about analytical test methods - which are laboratory procedures for sampling, preparing, and analyzing a specific matrix to determine the identity and concentration of the specified chemical. For this call-in, DTSC requests information about the analytical test methods to detect and measure these six nanomaterials in the environment. Specifically, "we seek relevant information about analytical test methods which identify and quantify these nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. (emphasis added).”
Although the nano metal oxides and quantum dots call-in is not yet finished, the carbon nanotubes call-in yielded some information, although probably not as in-depth as DTSC had hoped, leading some (myself included) to speculate that another call-in for carbon nanotubes is likely to happen in the future. The information gathered is available online, but the key takeaways, in regard to carbon nanotubes, are: 1) that companies and universities seem to have EH&S protective measures in place; 2) very little carbon nanotubes are being made or sold in California (except by Bayer, a statistic I found surprising), and, 3) that no California specific statistics were provided. Whether the metal oxides and quantum dots call-ins will reveal more robust information will be interesting; the questionnaire sent out was more pointed, so it stands to reason that the data gathered may be more detailed.
Although California cannot be faulted for seeking additional information about nanoparticles, the method it has chosen, i.e. mandatory call-ins, may be problematic for two main reasons. First, the definition of manufacturer under California law is very broad and includes not only a person who produces a chemical in California, but also a person who imports a chemical into California for sale in California. By targeting importers as well as manufacturers, California is casting a broad net. Parties who do not have or cannot obtain information from actual manufacturers or producers are potentially liable if they can not provide required information to DTSC. Although health and safety code provisions 57018-57020 do not set forth specific penalties, it is clear that DTSC believes it has the ability to take legal action against companies that fail to respond to the call-in.
The second potential problem with the call-ins is the relative lack of protection for confidential business information or trade secrets. Although DTSC’s intent with the call-ins was to “establish a collaborative dialogue on [nanomaterials],” barriers to creating a productive dialogue exist in this case because the law is a paper tiger when it comes to the protection of trade secrets. How weak is it? Stay tuned later this week for part 2 on this subject, where we explore the trade secret “protection” contained in section 57020 of the health and safety code.