Fumonisin B1 was listed as known to the state to cause cancer under Proposition 65 on November 14, 2003. On October 9, 2009, OEHHA proposed a “safe harbor level” for fumonisin B1 based on an expedited method allowed under applicable regulations. The Initial Statement of Reasons and the document describing the proposed safe harbor level for fumonisin B1 can be found here: http://www.oehha.ca.gov/prop65/law/fumonisin100909.html. On November 23, 2009, the Grocery Manufacturers’ Association (GMA) submitted comments objecting to the use of the expedited procedure for fumonisin B1 based on a number of scientific considerations. To evaluate the need for a conventional risk assessment, OEHHA would have to conduct a detailed review of the data submitted by GMA along with other relevant information that may be identified through an extensive literature search. Therefore, OEHHA is unable to complete the rulemaking process within the time allowed under the Administrative Procedure Act. By this Notice, OEHHA is hereby withdrawing its proposal to establish a specific level posing no significant risk using expedited methodology for fumonisin B1.
Background:
Proposition 65 prohibits a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical that has been listed as known to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual (Health and Safety Code Section 25249.6). The Act also prohibits discharges of listed chemicals to sources of drinking water. For chemicals known to the State to cause cancer, Proposition 65 provides an exemption from the above requirements when a person is able to demonstrate that an exposure poses no significant risk (Health and Safety Code Section 25249.9).
The Office of Environmental Health Hazard Assessment (OEHHA) develops regulatory levels posing no significant risk, also known as “safe harbor levels,” to assist interested parties in complying with the above requirements of the Act. On October 9, 2009, OEHHA proposed to establish a specific regulatory level for fumonisin B1 for adoption into Section 25705(d)(3) of the regulations. OEHHA developed the proposed No Significant Risk Level (NSRL) for fumonisin B1 using an expedited method.
OEHHA calculated the proposed NSRL using an expedited approach consistent with the procedures specified in Section 25703. Under this approach, an exhaustive literature search for chemical-specific data and subsequent analysis of these data to evaluate the scientific basis for the default assumptions are not required. To establish a de novo NSRL under Section 25705(b), OEHHA would have to conduct a much more extensive data review and analysis of the existing scientific literature. Section 25705(d)(2) provides that where the lead agency has established a safe harbor level for a chemical using an expedited method, “An interested party may request the lead agency to reevaluate a level established in this subsection based on scientific considerations that indicate the need for a conventional risk assessment.”
OEHHA has not yet established a safe harbor level for fumonisin B1 under this rulemaking. However, given that GMA has requested a conventional risk assessment and OEHHA is unable to evaluate the need for such an assessment prior to the expiration of this proposed rulemaking, OEHHA is withdrawing its proposal to establish an expedited safe harbor level for fumonisin at this time. OEHHA will provide a public notice and comment period in the event it decides to proceed with a new rulemaking regarding this chemical.
