California’s Department of Toxic Substances Control (DTSC) is currently drafting regulations to add Chapter 51.3 to the California Code of Regulations, under Title 22, Division 4.5. This new regulation would require that any human health risk screening or risk assessment shall use the most protective of the three federal and state accepted toxicity criteria sources for each cancer and non-cancer contaminant of concern for any site in California.
The agency announced it will begin the formal rulemaking process in 2017. Below are links to the three federal and state accepted toxicity criteria sources for each cancer and non-cancer contaminant of concern
1. Office of Environmental Health and Hazard Assessment Chemical Database, or its successor. As of November 12, 2015, the database is available online athttp://oehha.ca.gov/tcdb/index.asp
2. US EPA Integrated Risk Information System (IRIS) database. As of November 12, 2015, the database is available online at http://www2.epa.gov/iris
3. Provisional Peer-Reviewed Toxicity Value (PPRTV). As of November 19, 2015, these values are available online at http://hhpprtv.ornl.gov/quickview/pprtv.php
The proposed regulation reads as follows:
Division 4.5, Environmental Health Standards for the Management of Hazardous Waste Add Chapter 51.3, Article 1, sections 69000.1 – 69000.3 as follows:
69000.1. Purpose and Applicability
This chapter applies to hazardous waste and hazardous substance release sites subject to the provisions of Health and Safety Code, division 20, chapters 6.5, 6.8 and/or 6.82. It requires that the toxicity factors specified in 69000.3 be used to establish human health risk-based action levels and remediation goals.
69000.2. Action Levels, Screening Levels, Remediation Goals, and Point of Departure for Evaluation of Cleanup Alternatives
(a) The point of departure for action level and screening level determinations, and remediation goals, based on human health risk is: (1) An incremental excess lifetime cancer risk to an individual of 1 x 10-6, and (2) A cumulative hazard index across all pathways and contaminants of concern (COCs) of 1.0. (b) The above action levels, screening levels and remediation goals shall be calculated using the toxicity criteria specified in section 69000.3.
69000.3. Applicable Toxicity Criteria
Any human health risk screening or human health risk assessment shall use the most protective of the following three toxicity criteria sources for each cancer and noncancer contaminant of concern:
(a) The peer reviewed unit risk factors, inhalation and oral slope factors, and chronic reference exposure levels (cRELs, both inhalation and oral) from the Office of Environmental Health and Hazard Assessment
Assessment Chemical Database, or its successor.
(b) The unit risk factors, inhalation and oral slope factors, reference doses (RfD), and reference concentrations (RfC), from the US EPA Integrated Risk Information System (IRIS) database, or its successor.
(c) The unit risk factors, inhalation and oral slope factors, reference doses (RfD), and reference concentrations (RfC), from the U.S. EPA Provisional Peer-Reviewed Toxicity Value (PPRTV) database, or its successor.
In addition to the draft proposed language above, DTSC will solicit comments on the alternative concept of implementing a narrative standard to require use of state Toxicity Criteria when they are more protective than the other two federal sources.
All members of the public, the regulated community, and other stakeholders are welcome to submit written comments until January 16, 2017 to the following address:
Department of Toxic Substances Control
8800 Cal Center Drive
Sacramento, California 95826
Attn: Mr. Kevin Depies
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