OEHHA Posts Comments on Revised Proposed Regulation for Hazard Traits and Environmental and Toxicological Endpoints

Posted on September 26, 2011 by Lynn L. Bergeson

The Office of Environmental Health Hazard Assessment (OEHHA) has posted comments received on its July 29, 2011, revised proposed regulation concerning the specification of hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in California’s Toxics Information Clearinghouse.  The California Department of Toxic Substances Control (DTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. OEHHA’s August 2010 pre-regulatory draft regulation included a “nanomaterial hazard trait,” as well as other references to nanoparticles, which OEHHA removed from its December 17, 2010, draft regulation. The revised regulation does not refer to nanomaterials or nanoparticles, but includes the following definition regarding particle size or fiber dimension:

(a)        The particle size or fiber dimension hazard trait is defined as the existence of a chemical substance in the form of small particles or fibers or the propensity to form into such small-sized particles or fibers with use or environmental release.

(b)        Evidence for the particle size or fiber dimension hazard trait includes, but is not limited to:  measures of particle size less than or equal to 10 micrometers in mass median aerodynamic diameter for inhalation exposure, or less than 10 micrometers in any dimension for dermal or ingestion exposure, or fibers with a 3:1 aspect ratio and a width less than or equal to 3 micrometers.

 

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OEHHA Revises Proposed Regulation for Hazard Traits and Environmental and Toxicological Endpoints

Posted on July 29, 2011 by Lynn L. Bergeson

The Office of Environmental Health Hazard Assessment (OEHHA) announced on July 29, 2011, that it revised its proposed regulation concerning the specification of hazard traits, environmental and toxicological end-points, and other relevant data that are to be included in California’s Toxics Information Clearinghouse.  The California Department of Toxic Substances Control (DTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. Comments are due September 12, 2011.

OEHHA’s August 2010 pre-regulatory draft regulation included a “nanomaterial hazard trait,” as well as other references to nanoparticles, which OEHHA removed from its December 17, 2010, draft regulation. The current draft regulation does not refer to nanomaterials or nanoparticles. It includes the following definition regarding particle size or fiber dimension:

(a)  The particle size or fiber dimension hazard trait is defined as the existence of a chemical substance in the form of small particles or fibers or the propensity to form into such small-sized particles or fibers with use or environmental release.

(b)  Evidence for the particle size or fiber dimension hazard trait includes, but is not limited to: measures of particle size less than or equal to 10 micrometers in mass median aerodynamic diameter for inhalation exposure, or less than 10 micrometers in any dimension for dermal or ingestion exposure, or fibers with a 3:1 aspect ratio and a width less than or equal to 3 micrometers.
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UCSF's Program on Reproductive Health and the Environment Publishes Recommendations for Addressing Health Risks from Nanomaterials in California

Posted on May 10, 2011 by Lynn L. Bergeson

Last week, the University of California, San Francisco’s (UCSF) Program on Reproductive Health and the Environment announced the publication of its “Recommendations for Addressing Potential Health Risks from Nanomaterials in California,” which provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA) and to the state of California.  OEHHA contracted with UCSF to prepare the report, which provides an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology. Recommendations include those that can be implemented under the existing regulatory structure of OEHHA, such as establishing a publicly accessible clearinghouse and inventory of nanomaterial sources and products. The report also includes recommendations that are outside the scope of OEHHA, many of which may require legislative changes, such as requiring testing of release and exposure potential for nanomaterials in existing and new consumer products, and implementing a labeling system that requires labeling of products that contain nanomaterials.  According to UCSF, the recommendations primarily focus on requiring information on potential exposures and health hazards for nanomaterials used in the marketplace.

The recommendations for OEHHA to address health risks from nanomaterials that can be achieved under the existing regulatory structure are:

  1. Develop a definition of nanomaterials that can be used to identify them;
  2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial;
  3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties;
  4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products;
  5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring;
  6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media;
  7. As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT);
  8. Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure;
  9. Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed;
  10. Integrate nanomaterials into current efforts to modernize toxicity testing;
  11. Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity;
  12. Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and non-governmental organizations; and
  13. Continue to include opportunities for public input and comment during decision-making processes.

The recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA are:

  1. Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products;
  2. Require reporting of properties that can identify nanomaterials that are PBTs. Phase out uses consistent with approaches for other PBTs;
  3. Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential;
  4. Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products;
  5. Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials;
  6. Require sufficient toxicological testing -- preferably pre-market and also post-market as necessary -- to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants;
  7. Implement a labeling system that requires labeling of products that contain nanomaterials;
  8. Increase funding and support for targeted, nano-specific research to fill data gaps; and
  9. Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.
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California Removes Nano References in the Revised Safer Consumer Product Alternatives Regulations

Posted on November 19, 2010 by Lynn L. Bergeson

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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OEHHA Announces Draft Nanotechnology Policy Framework for California

Posted on April 23, 2010 by Lynn L. Bergeson

On April 22, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) announced that, on May 5, 2010, the University of California at San Francisco’s (UCSF) Program on Reproductive Health will hear comments from an expert panel and the public on a draft UCSF document entitled “A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California.” The draft document includes a number of recommendations for OEHHA and other California policymakers about nanomaterials, including recommendations on assessing their risks. According to UCSF, following the meeting, it will prepare the document in final and present it to OEHHA “to better inform their risk assessment recommendations for decision makers and risk managers.” The draft document includes recommendations concerning characterizing nanomaterials for hazard identification and exposure potential; indentifying sources of nanomaterials; addressing exposure to nanomaterials; prioritizing and characterizing health effects; testing products for safety; and engaging and informing the public. The draft report recommends that, as a first step, “OEHHA should evaluate and ensure that nanomaterials are integrated into their programs and activities in parallel with conventional chemicals.” In addition, the draft report outlines recommendations intended to address nanomaterial concerns and identifies the OEHHA programs through which these recommendations can be implemented.

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