Beveridge & Diamond
 

California Releases Chemical Hazard Trait “Green Chemistry” Pre-Regulatory Draft Regulations

Beveridge & Diamond, P.C., August 30, 2010

Introduction

In mid-August 2010, Cal EPA’s Office of Environmental Health Hazard Assessment (“OEHHA”) released a “pre-regulatory” draft of its Green Chemistry regulations (“Pre-Regulatory Draft”) that identify hazard traits and environmental and toxicological endpoints for the state’s Toxic Information Clearinghouse, a website for chemicals data.   Coming on the heels of the Department of Toxic Substances Control’s (“DTSC”) June 2010 release of its Green Chemistry Draft Regulation for “Safer Consumer Products,” OEHHA’s Pre-Regulatory Draft moves California closer to fulfilling the mandate of its Green Chemistry statutes.

California Health & Safety Code § 25256.1 charges OEHHA with identifying and evaluating chemical hazard traits – chemical properties that could impact human health or the environment – and toxicological endpoints.  The chemical information and assessments generated by OEHHA will be included in the Toxics Information Clearinghouse that DTSC has been tasked with developing under California Health & Safety Code § 25252.  Intended to be a publicly available online resource for the collection, maintenance, and distribution of chemicals data, the Clearinghouse would allow consumers, manufacturers, and the scientific community to search for data on chemical hazards through a single web-based portal.  DTSC anticipates that the Clearinghouse will be in full operation by Spring 2011.

The hazard traits and endpoint information, as well as any other relevant chemical data identified by OEHHA, are important because DTSC is expected to use this data in it decision-making about chemicals of concern in consumer products.  (Please click here for our prior news alert on the DTSC’s Draft Regulation for Safer Consumer Products.)  OEHHA’s Pre-Regulatory Draft is intended to give stakeholders a preview of the agency’s thinking on the regulations and an opportunity for early feedback, prior to the initiation of the formal rulemaking process, which is expected to commence later this Fall.

Draft Regulations

In its Pre-Regulatory Draft, OEHHA has identified four broad types of hazard traits to be considered for chemicals used in consumer products, and has listed 41 specific hazard traits within the four categories.  The four broad hazard trait categories are enumerated below, along with their definitions and, in the parentheticals, examples of some of the various 41 specific hazard traits presented in the Pre-Regulatory Draft:  

  • Toxicological - hazard traits that affect human health (e.g., carcinogenicity, developmental toxicity, reproductive toxicity);
  • Environmental - hazard traits that affect the environment (e.g., eutrophication, loss of genetic diversity, wildlife survival impairment)
  • Exposure Potential - hazard traits based on increased likelihood of chemical exposure to people or wildlife (e.g., ambient ozone formation, bioaccumulation, global warming potential)
  • Physical Hazard Traits - hazard traits that may affect human health or the environment (e.g., explosivity, flammability, radioactivity)

In addition to the specific hazard trait examples provided above, among the specific hazard traits presented in the Pre-Regulatory Draft are a nanomaterial hazard trait, based on a substance as possibly having greater toxicity when in nanoparticle form, and a hazard trait based on stratospheric ozone depletion potential.  Whether each of the 41 specific hazard traits is proper to include in the actual proposed regulations will be the subject of additional deliberation over the coming weeks.

The Pre-Regulatory Draft also sets forth proposed ways to determine whether a given chemical has a certain hazard trait and to measure the hazard.  Under the proposed regulation, provided that there is adequate information, a chemical’s hazard traits would be classified based on the strength of existing scientific evidence.  For “Class One” hazard traits, there must be strong evidence from an authoritative body (e.g., National Academy of Sciences, Consumer Product Safety Commission, International Agency for Research on Cancer) indicating that the chemical has the specific hazard trait.  For “Class Two” hazard traits, there needs to be only suggestive evidence of the particular hazard trait for the chemical.   OEHHA would also have discretion to determine that there is insufficient information available to classify a hazard trait for a specific chemical, in which case the hazard trait would be deemed as “Not Classifiable.” 

Though such hazard trait classifications may be regarded as a simple organizational tool to give structure to the Clearinghouse, they are of critical importance and have been subject to public scrutiny given the role OEHHA’s designations will likely play in DTSC’s identification of chemicals of concern (and the subsequent regulation of consumer products containing those chemicals).  There are concerns over whether two classes of hazard traits adequately differentiate the scientific data available for a given chemical.  Along those lines, there are also concerns that even within a class, the range and depth of the available scientific data may be widely disparate for hazard traits between chemicals and that strong evidence for the hazard traits of one chemical may not be equivalent to the evidence for another chemical’s hazard traits given the same Class One classification.  In other words:  For many chemicals OEHHA will have broad discretion to decide whether a hazard trait should be Class One, Class Two or Not Classifiable. 

Like DTSC, OEHHA appears on track to adopt its Green Chemistry regulations by the January 1, 2011 statutory deadline imposed by Section 25256.1 of the California Health & Safety Code.  It will be taking comments on its Pre-Regulatory Draft through September 13, 2010, after which it will review and revise its regulations and subject them to a peer review.  Accordingly, all interested parties are encouraged to review OEHHA’s Pre-Regulatory Draft and to consider submitting comments prior to and during the formal rulemaking process, which is expected to commence in late September or early October 2010. 

For additional information on California’s Green Chemistry Initiative, please contact Kenneth Finney at kfinney@bdlaw.com, Laura Duncan at lduncan@bdlaw.com or Ryan Tacorda at rtacorda@bdlaw.com.  

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