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Safe Use Determination: What is it and Who Can Request it?

Safe Use Determinations” (SUDs) are statements issued by the California Office of Environmental Health Hazard Assessment (OEHHA) providing guidance on Proposition 65. The written guidance is intended to apply Proposition 65 regulations to particular facts presented by a business regarding its activities and compliance with the statute. A SUD can only be requested and relied upon as it pertains to a discrete set of facts under specific conditions. Similarly, the SUD can only be granted for the chemical identified in the request and not for other listed chemicals that are present in the product. Even with these restrictions, SUDs may offer another means of helping businesses decide the most taxing question surrounding this statute – do I need a warning?

In many cases, a business that seeks a SUD is confident that its products are not subject to the warning requirements under Proposition 65. However, this mechanism can provide additional assurances to a business that it has complied with the law. In a SUD, OEHHA determines whether an exposure to a listed chemical under specified circumstances must be accompanied by a warning. OEHHA considers the use of the product giving rise to the exposure and uses its best judgment to render a decision about the level of exposure to the chemical that requires warning.

There are several criteria for a company to be eligible to request a SUD. OEHHA requires that: (i) the business is subject to Proposition 65, (ii) the chemical that is the subject of the inquiry is a listed substance under Proposition 65, (iii) the use evaluated by OEHHA is an actual rather than an hypothetical activity, and (iv) the request does not involve a matter that is the subject of a civil or criminal case pending in court, a violation notice by the Attomey General, or an administrative proceeding at the federal, state or local level.

OEHHA sets forth specific requirements for a SUD request. The applicant must supply OEHHA with all the information specified in the regulations. In general, the more data supplied by the company relevant to the inquiry, the higher the likelihood that a SUD will be issued. This may include product analysis data, exposure data, and information related to how the product is used.

Still, SUDs are relatively rare. OEHHA has only issued a small number of such determinations since Proposition 65 was enacted. In addition, SUDs are expensive for the companies that make such requests, since they must retain experts to undertake the required analyses and also reimburse OEHHA for their in-house evaluation of the SUD request. Further – and most important – having a SUD does not prohibit a Proposition 65 lawsuit from being filed for that same exposure, though it can be a strong disincentive for Proposition 65 private enforcers. Given their high cost and limited utility in preventing lawsuits, perhaps it is no wonder that SUDs are not the top choice for businesses seeking certainty in their Proposition 65 compliance efforts.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.