Regulatory Developments

California Lists Nickel (Soluble Compounds) on Prop 65 as Known to Cause Reproductive Toxicity

October 29, 2018

Effective October 26, 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 Proposition 65 (Prop 65).  Importantly, “soluble” is not defined in the listing.  On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts” (SQE), determined that soluble nickel compounds were shown to cause reproductive toxicity based on the developmental and male reproductive endpoints.  The listing of nickel (soluble compounds) means that 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 of 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 the evidence of developmental and male and female reproductive toxicity 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 hazard identification document, OEHHA sent additional studies to DARTIC members.  Comments on the hazard identification document that were timely filed 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.  According to the comments, “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.

Commentary

As reported in our March 19, 2018, memorandum, “August Deadline Looming for OEHHA’s Amended Proposition 65 Clear and Reasonable Warning Requirements,” and May 23, 2018, memorandum, “Three Months until Effective Date for OEHHA’s Amended Proposition 65 Clear and Reasonable Warnings Requirements,” OEHHA’s amended “clear and reasonable warnings” regulations took effect on August 30, 2018.  The memoranda discuss major changes to the 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.
 
In one year, on October 26, 2019, businesses will be required to 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 are not required based on exposure assessments conducted indicating that the exposure to nickel (soluble compounds) falls below an established “safe harbor” level.  OEHHA has not yet, however, developed a safe harbor level (i.e., Maximum Allowable Dose Levels (MADL) for chemicals listed as causing birth defects or other reproductive harm) for nickel (soluble compounds), and it unfortunately is unclear if or when such a level would be developed.  Although OEHHA has several distinct 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 -- safe harbor levels have been developed by OEHHA for only two of these:  Nickel refinery dust from the pyrometallurgical process and Nickel subsulfide.  If required, the warning can be provided 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) are present 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.


 
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