OEHHA Issues Final Regulations Concerning Toxics Information Clearinghouse
On January 18, 2012, the California Office of Environmental Health Hazard Assessment (OEHHA) issued final regulations that “specify the hazard traits, toxicological and environmental endpoints and other relevant data to be included” in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (DTSC) will develop. The Clearinghouse will be used, in part, to help DTSC identify chemicals of concern in consumer products as part of its Green Chemistry Initiative and Safer Consumer Products Alternatives regulations. The Clearinghouse also “will provide basic scientific information that will be available to agencies, the public, and industry and government scientists and engineers evaluating chemicals in consumer products.” The regulations were effective on January 19, 2012.
As background, OEHHA published the Initial Statement of Reasons for the Clearinghouse on December 17, 2010, and held a public hearing on January 30, 2011. The initial comment period ended on February 15, 2011, and OEHHA received 26 comments. OEHHA published modified proposed regulations on July 29, 2011, together with a notice for a second comment period that ended September 12, 2011. OEHHA published a notice for a third comment period on October 7, 2011, that ended on October 24, 2011. OEHHA states that no modifications were made in response to the six comments that were received during the third comment period. Information about the proposal is available online and at Bergeson & Campbell, P.C.’s Nano and Other Emerging Chemical Technologies Blog.
OEHHA states that the final regulations are intended to provide “a structure for relating scientific information to the hazard traits, and general guidance on whether or not a given chemical exhibits a hazard trait based on the scientific evidence.” § 69401.1. OEHHA organized the regulations around four major categories of hazard traits: toxicological, environmental, exposure potential, and physical. Within the toxicological and environmental hazard trait categories (e.g., carcinogenicity, cardiovascular toxicity, domesticated animal toxicity, phytotoxicity), the regulations define each of those hazard traits, list general categories of endpoints for each hazard trait, and provide “other relevant data” for each hazard trait. While OEHHA provides general methods for determining whether a chemical substance has a toxicological hazard trait, it provides more specific methods for determining whether a chemical substance has a carcinogenicity, developmental toxicity, or reproductive toxicity hazard trait. Within the exposure potential and physical hazard traits categories (e.g., ambient ozone formation, global warming potential, flammability), the regulations define each of those hazard traits and provides what OEHHA considers to be “evidence” of such a hazard trait (i.e., data from scientific studies that can be used to determine the presence or absence of the hazard trait). OEHHA also provides a non-exclusive list of “additional relevant data” that may be useful in evaluating chemicals.
Nanomaterials and nanoparticles are not mentioned specifically in the final regulations. “Particle size or fiber dimension” is listed, however, as an “exposure potential” hazard trait with the following definition and “evidence”:
§ 69405.7 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.
In its Final Statement of Reasons, OEHHA summarizes its response to comments submitted during the three comment periods. In the last round of comments, OEHHA noted that many of the comments received did not address the proposed changes to the regulations that were the subject of the 15-day Notice, or the procedures used to propose it. OEHHA stated that it was not responding to comments that addressed or repeated comments submitted on the December 2010 version of the proposed regulations. In response to one comment concerning the addition of the word “potential” in relation to the presence of a hazard trait and the fact that this addition “appears to direct the hazard trait framework toward a more precautionary approach effort” which is “inconsistent with the intent of the enacting statutes, which require that the framework be based in sound science rather than precaution,” OEHHA responded as follows:
Response: The comment refers to a sentence in Section 69401.1 that describes other relevant data as follows: “These data can be observed through scientific study and provide less-direct but useful evidence of the potential presence of a hazard trait.” Non-exclusive lists of different types of other relevant data are included in the regulation for toxicological and environmental hazard traits. The addition of the word “potential” in front of “presence of a hazard trait” clarifies that the other relevant data may indicate, rather than definitely indicate, the presence of a hazard trait. Note that this regulation does not classify any chemical as having or not having a hazard trait. Rather, the regulation identifies the types of information (hazard traits, toxicological and environmental endpoints, and other relevant data) to be included in the Toxics Information Clearinghouse. No change was made in the regulation in response to this comment.
The Clearinghouse regulations have not changed dramatically since they were first proposed in December 2010, and have not changed at all since the third comment period was opened in October 2011. The issuance of final regulations regarding the Clearinghouse is an important step in DTSC’s development of its Safer Consumer Products Alternatives regulations, since DTSC is required to use OEHHA’s hazard trait identifications to assist in identifying chemicals of concern in consumer products.