On December 21, 2010, the California Department of Toxic Substances Control (DTSC) issued a much anticipated data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. This DCI follows up on a 'round one' DCI, the DTSC issued in January 2009 on carbon nanotubes. This column discusses the DCI approach and what the results of a successful 'round two' DCI experience might mean for nano stakeholders.
California Health and Safety Code Sections 57018-57020 were enacted in 2006 with the adoption of Assembly Bill 289. The law authorizes DTSC to make available information on chemical substance fate and transport, detection and analysis, and related information. Under the law, DTSC is authorized to place the responsibility of providing this information on the manufacturers and importers of the chemicals on which information is being requested.
According to DTSC, Health and Safety Code Section 57018(a)(4) defines a 'manufacturer' as a 'person who produces a chemical in this state or imports a chemical into this state for sale in this state.' Accordingly, DTSC states, 'persons and businesses who produce or import one or more of the above chemicals, in any quantity, must comply with the statute and this request.'
Round One -- Carbon Nanotubes
In 2009, DTSC sent formal requests for information to 26 California companies and institutions and asked six questions. The information requested focused on methods for protecting workers in the research, development, and manufacturing environments, information pertinent to the value chain and business life cycle of carbon nanotubes, sampling, measurement, and detection methods, and information on the safety of recipient's carbon nanotube with respect to occupational, safety, and public health, and potential releases of carbon nanotubes into the environment.
Of the 26 entities that received the DCI, approximately 22 companies submitted information to DTCS. Several companies were no longer in business and one claimed it did not produce carbon nanotubes. All responses are posted on DTSC's website. The UCLA School of Law evaluated the responses. It concluded the information received was limited and that responses varied quite significantly.
Round Two -- Nano Metal Oxides and Quantum Dots
In issuing the second DCI, DTSC reported that little to no information on analytical test methods for these nanomaterials in the human body or the environment now exists. The specific nanomaterials for which DTSC seeks information are: nanosized titanium dioxide, zinc oxide, cerium oxide, silver, quantum dots, and zero valent iron. To understand better the behaviour, fate, and transport of these nanomaterials, DTSC needs 'appropriate analytical test methods' for manufacturers, contract and reference laboratories, and regulatory agencies. DTSC states that manufacturers 'may be required to develop information consistent with the requirements of Health and Safety Code section 57019(c) and (d).'
Manufacturers, including importers, must provide the requested information no later than one year from DTSC's December 21, 2010, letter, or by December 20, 2011, however, 'timely attention and response is preferred.' The information DTSC seeks includes 'information about analytical test methods, physicochemical properties, toxicity, and fate and transport of these nanomaterial chemicals are generally unknown or unavailable.' DTSC claims to be specifically interested in information related to 'analytical test methods for these chemicals in environmental matrices, including water, air, soil, sediment, sludge, and chemical waste.'
Responding to the DCI
In an effort to orchestrate a more organized and useful response, BASF Corporation (BASF) has stepped-up and organized an effort to facilitate the development of a coordinated response. Dr. Ray David, BASF, working with B&C Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C., are collaborating as volunteers to help create a consortium to provide the DTSC information on the analytical methods it seeks that could be used to measure certain nanoscale materials in air, surface water, and soil. The collaborative project will involve adapting known methods used to measure these substances in other media to the analysis of environmental media. The term of the consortium will be at least two years, which can be modified by mutual agreement. Experts within BASF will address issues concerning titanium dioxide and zinc oxide.
BASF and BCCM seek other companies and experts to provide similar expertise for the other nanomaterials of interest to provide DTSC with the help it needs. For more information, please contact Raymond M. David, Ph.D., BASF, at firstname.lastname@example.org or Kathleen M. Roberts, BCCM, at email@example.com.