The State of California now has over 900 chemical substances for which warning and labeling is required under Proposition 65 (Prop 65). Recently added to this list are soluble nickel compounds. Given the potential ubiquity of the substance, this could have big implications.

On October 16, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) added nickel (soluble compounds) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Prop 65. Importantly, “soluble” is not defined in the listing. On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), as the “state’s qualified experts,” determined that soluble nickel compounds were shown to cause reproductive toxicity based on developmental and male reproductive endpoints. The listing of nickel (soluble compounds) means warning requirements will apply in one year, or as of October 26, 2019.

Background

OEHHA announced on July 27, 2018, the availability for public review the hazard identification document entitled “Evidence on the Developmental and Reproductive Toxicity of Nickel and Nickel Compounds.” DARTIC considered this document in making its listing decision on nickel (soluble compounds) at its October 11, 2018, meeting. In preparing the hazard identification document, OEHHA issued a request for information relevant to the assessment of developmental and male and female reproductive toxicity evidence for nickel and nickel compounds.

The data call-in (DCI) period for nickel and nickel compounds opened on February 19, 2016, and closed on April 4, 2016. OEHHA considered information received from the DCI in preparing the hazard identification document. After completing the document, OEHHA sent additional studies to DARTIC members. Timely filed comments were provided to DARTIC in advance of the meeting. The September 11, 2018 comments submitted by NiPERA, Inc. seem to align with OEHHA’s decision: “the Prop 65 listing of soluble nickel compounds based on rodent developmental effects is warranted, with the most sensitive effect being perinatal mortality.” Soluble nickel compounds reflect the highest bioavailability.

Discussion

OEHHA’s new and more-detailed “clear and reasonable warnings” regulations took effect on August 30, 2018. These new regulatory amendments ushered in major changes to requirements, including consumer product exposure warnings (e.g., content, short-form warning, foreign language requirements, and method of transmission); warning responsibility; and new specific product, chemical and area exposure warnings.

By October 26, 2019, businesses must provide a “clear and reasonable” warning as amended, before knowingly and intentionally exposing anyone to nickel (soluble compounds). Limited exceptions apply, for example, if a business can show that Prop 65 warnings aren’t required based on exposure assessments conducted indicating exposure to nickel (soluble compounds) falls below an established “safe harbor” level (i.e., maximum allowable dose levels (MADL) for chemicals listed as causing birth defects or other reproductive harm). However, OEHHA hasn’t yet developed a safe harbor level for nickel (soluble compounds), and is unclear when it might do so. In fact, of OEHHA’s several listings for nickel — nickel (metallic), nickel acetate, nickel carbonate, nickel carbonyl, nickel compounds, nickel hydroxide, nickelocene, nickel oxide, nickel refinery dust from the pyrometallurgical process, and nickel subsulfide — only the latter two have designated safe harbor levels.

The warning, if required, can appear in several ways depending on the type of exposure, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper.

Companies thus should determine if nickel (soluble compounds) occur at any concentration in consumer products to be sold or distributed in California or in occupational or environmental settings in California, and if so, whether warnings may be required, the content of such warnings, and in what form those warnings must be communicated. Given the ubiquity of nickel in a wide range of products, this regulatory determination could prove significant. Although October 2019 sounds far off, it is right around the corner.

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LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at lbergeson@putman.net

Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.