Approximately seventeen years ago, the Office of Environmental Health Hazard Assessment (“OEHHA”), the lead agency for Proposition 65, issued a regulation (now in 27 CCR 25204) stating that
As a part of its overall responsibility to provide guidance to persons or organizations that are or may be affected by the Act, the lead agency will consider the applicability of the Act or the exemptions specified in the Act to business activities or prospective business activities. A safe use determination issued by the lead agency represents the state's best judgment concerning the application of the Act to the particular facts presented in the request.
Just as it can be very expensive for a company to defend a Proposition 65 suit by proving that the exposure level is below the No Significant Risk Level for listed carcinogens (“NSRL”) and/or below the Maximum Allowable Dose Level for reproductive toxicants (“MADL”), obtaining a Safe Use Determination (“SUD”) isn’t easy either. First of all, it can’t be done by a company that has received a notice of violation for the product and chemical in question.
And secondly, the expense can be high: The submitting party must provide scientific evidence in support of its request, which is not inexpensive to obtain and assemble. The current version of the regulation must first be accompanied by a $1,000 non-refundable processing fee. But next, “the requester shall be assessed a charge in the amount of any costs to the lead agency or other state agency which are necessarily incurred in considering the request and which exceed $1,000.” And these costs just about always exceed $1,000 by a great deal, although probably less than defending enforcement litigation.
Nonetheless, it can make a great deal of sense when the SUD is requested by and successful for an industry organization. This is what was successful for "The Vision Council" after it requested a SUD as to exposures to BiPhenol A ("BPA") from certain polycarbonate prescription glasses and sunglasses, over-the-counter reading glasses, non-prescription sunglasses, and safety glasses.
BPA is listed as a female reproductive toxicant. And under the regulations setting maximum allowable dose levels (i.e., "MADL," the safe harbor levels for listed reproductive toxicants), the MADL for BPA, for dermal exposure from solid materials, is 3 micrograms per day of exposure. In undertaking its SUD analysis, OEHHA drew these conclusions:
Based on OEHHA’s screening-level analysis of the information and data provided by TVC, the upper-end estimate of dermal exposure to BPA for users of certain polycarbonate eyewear products (prescription glasses and sunglasses, OTC reading glasses, non-prescription sunglasses, and safety glasses) manufactured, distributed, or sold by TVC member companies, with acetonitrile extractable concentrations of BPA as specified above, is 0.53 µg/day. This exposure estimate falls below the "Maximum Allowable Dose Level (MADL)” for BPA (dermal exposure from solid materials) of 3 µg per day. The MADL is defined as the level of exposure that corresponds to the “no observed effect level” divided by 1000. Thus, exposures to BPA from use of such eyewear products, under the conditions described in OEHHA’s assessment, would not require a Proposition 65 warning.
So, to make a long story short: No Proposition 65 warning about BPA is required for plastic-framed glasses. This suggests that a SUD can be useful at times for an industry.
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