On November 25, 2015, the California Office of Environmental Health Hazard Assessment released a Safe Use Determination for Diisononyl Phthalate in Certain Single-Ply Polyvinyl Chloride Roofing Membrane Products. This is the third Safe Use Determination that OEHHA has issued in the nearly thirty years since Proposition 65 was enacted.
A Safe Use Determination (SUD) is a written statement issued by OEHHA, applying Proposition 65 to a specific listed chemical and exposure scenario and determining whether or not the exposure to the listed chemical is below the warning trigger for the chemical. Intended as a means to provide businesses with formal assurance about their obligation to provide Proposition 65 warnings for specific exposures, the SUD process historically has involved a tremendous amount of resources and time both by the entity requesting the SUD and OEHHA. In addition to paying its own expert, the requestor must reimburse OEHHA for its staff review of the SUD request. Further, a business receiving an SUD is not immunized from an enforcement action (though, as a practical matter, it would be unlikely for an enforcement action to be initiated against an entity having received an SUD). Over the years, these factors have combined to make the SUD process an expensive, time-consuming, uncertain — and ultimately unattractive — means for a business to ascertain whether or not to provide Proposition 65 warnings.
In late 2014 and early 2015, OEHHA received four SUD requests, all relating to diisononyl phthalate but in different products: vinyl flooring, specific vinyl carpet tiles, outdoor furniture products and PVC roofing membrane products. The recently issued SUD for roofing membrane products presumably is the first of the four to be issued. Although specific to this category of products, the SUD offers insights into OEHHA’s approach for DINP exposure calculations, including dermal absorption exposure factors and hand-to-mouth exposure factors. Businesses may use these factors in DINP exposure calculations for their own products; enforcers would be hard-pressed to argue that OEHHA, the state agency charged with implementing the law, is wrong about them.
As businesses continue to press for greater certainty about “when to warn” (as opposed to the “how to warn” that is the subject of OEHHA’s most recent regulatory proposal) OEHHA’s issuance of this SUD may mark the beginning of a new wave of SUD requests. Still, the cost and time involved likely will curb many businesses from initiating this process. GLO is aware that, for this SUD, OEHHA charged the requestor $43,000 — that is in addition to the fees and costs of the requestor’s own consultants and attorneys, which are unknown but likely substantial. SUDs will remain a Proposition 65 tool accessible only by those businesses with the necessary resources to commit a regulatory process with an uncertain outcome.