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

On December 21, 2010, the California Department of Toxic Substances Control (CDTSC) issued a 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. According to CDTSC, 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, CDTSC 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.” CDTSC requests information about the analytical test methods that identify and quantify the specified nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. CDTSC states it determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists.  To better understand the behavior, fate, and transport of these nanomaterials, CDTSC needs “appropriate analytical test methods” for manufacturers, contract and reference laboratories, and regulatory agencies.  CDTSC 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 CDTSC’s December 21, 2010, letter, however, “timely attention and response is preferred.”

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On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. Of particular note, CDTSC has removed all references to nanotechnology and nanomaterials in the proposed regulations, which previously defined nanomaterials and included “physical, chemical, or quantum properties specific to nanomaterials” on the list of prioritization factors that CDTSC would consider in placing chemicals on the list of Chemicals Under Consideration. The revised proposed regulations also no longer exclude nanomaterials from the de minimis exemption. Under the Green Chemistry Program, the Office of Environmental Health Hazard Assessment (OEHHA) will specify the hazard traits, environmental and toxicological end-points, and other relevant data to include in the state’s Toxics Information Clearinghouse. CDTSC will use information from the clearinghouse to help identify chemicals of concern in consumer products. OEHHA’s pre-regulatory draft regulation includes reference to nanoparticles and defines a “nanomaterial hazard trait.” Comments on CDTSC’s revised proposed regulations are due December 3, 2010.

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On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA’s efforts related to CNTs. The candidate chemicals for CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions.

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The California Department of Toxic Substances Control (CDTSC) has rescheduled its workshop on state and federal nanomaterial activities for September 22, 2010. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. The workshop is open to the public.

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According to the California Department of Toxic Substances Control's (CDTSC) website, it is drafting a memorandum of understanding (MOU) with the U.S. Environmental Protection Agency (EPA) to facilitate information exchange, collaboration, and outline a working partnership on emerging chemicals, green chemistry, and materials management. Under the new MOU, EPA and CDTSC will:

1.  Establish chemical specific teams for priority chemicals of mutual interest;

     a.  Teams will develop specific goals, points of coordination, and focus areas.

2.  Share information on analytical methods, fate and transport, bioconcentration, toxicity, exposure, risk assessment, and similar topics relative to emerging chemicals;

3.  Share literature reviews, databases;

4.  Collaborate on identifying and prioritizing information and data gaps;

5.  Keep each other informed on workshops, symposia, web events, etc.;

6.  Share value-chain information (to the extent allowed by law):

     a.  Producers, importers;

     b.  Production volumes; and

     c.  Applications/intermediates/products.

7.  Explore ways to exchange information while protecting CBI; and

8.  Collaborate on research needs and funding. 

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Due to California’s budget issues and resulting furlough for civil service employees, the California Department of Toxic Substances Control (CDTSC) has postponed its August 13, 2010, workshop on state and federal nanomaterial activities. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. CDTSC states that it will reschedule the workshop at a later date.

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On March 19, 2009, the California Department of Toxic Substances Control (CDTSC) will hold a full-day nanotechnology symposium on nanomaterials regulation from a variety of perspectives. According to CDTSC, the symposium will focus on the regulatory aspects of nanotechnology, the role of the U.S. Environmental Protection Agency (EPA), and CDTSC’s chemical information call-in program including nanoscale materials. CDTSC states that federal interest in nanomaterial regulation and California’s efforts “provide a great opportunity for fostering technological advances that recognize environmental and public health concerns. The goal is to create a partnership where we can enhance research where needed and promote sustainable processes as well as applications.” Registration is required. The symposium will also be available via web cast.

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The California Department of Toxic Substances Control (CDTSC) will hold a symposium entitled “Nanotechnology Symposium II:  Potential Hazards of Nanomaterials in the Environment” on October 3, 2007. The draft agenda includes the following topics: 

• Chemical Properties and Commercial/Industrial Applications of Nanotechnology;
• Physico-Chemical Characterization of Nanoparticles and Its Relation to Their Bio-Interactions;
• Potential Ecotoxicity of Nanoparticles Released to the Environment;
• Nanomaterial Human Health Risks and Risk Assessment; and
• One Proactive Approach to Responsible Nanotechnology Development:  The DuPont -- Environmental Defense NanoRisk Framework.

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