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OEHHA Provides Guidance on Safe Harbor Warnings for Lead Under New Regulations

The Office of Environmental Health Hazard Assessment (OEHHA) has provided guidance on how to provide warnings for lead under the new safe harbor warning regulations in Title 27, California Code of Regulations, sections 25601, et seq. This guidance, provided in response to Grimaldi Law’s request for interpretation, clarifies that businesses may use the term “lead” in a combination warning, i.e., a warning addressing both the cancer and reproductive harm endpoints, as set forth in Section 25603(a)(2)(D) of the new safe harbor warning regulations – notwithstanding the fact that the formal identification for lead as a carcinogen is “lead and lead compounds.”‘

Background

Proposition 65 requires businesses with 10 or more employees to provide a “clear and reasonable warning” before exposing individuals to a Proposition 65-listed chemical, if the exposure to that chemical is above its regulatory warning level. Since 1988, the Proposition 65 regulations have set forth the warning language and method of transmission for “safe harbor” warnings, i.e., warnings that shall be deemed clear and reasonable as matter of law. While it is highly advisable that businesses comply with the safe harbor warning regulations to avoid litigation, safe harbor warnings are not mandatory and businesses may choose to provide an alternate warning as long as that warning is clear and reasonable.

In August 2016, OEHHA revised the safe harbor warning regulations. The new regulations become fully effective on August 30, 2018. Until then, businesses may use either the “old” safe harbor warnings or the new ones. Among many other changes, safe harbor warnings now must identify one or more chemicals for each health endpoint being warned for, cancer or reproductive harm.

Recent OEHHA guidance requires that the chemical be identified by the same name appearing on the Proposition 65 list. That requirement was the basis for Grimaldi Law’s request for interpretation, for “lead and lead compounds” is the term used to identify lead as a carcinogen, and “lead” is the term used to identify lead as a reproductive toxicant. Should businesses wishing to use a combination safe harbor warning parse out those terms between the two endpoints of cancer and reproductive harm, as Section 25603(a)(2)(C) would seem to require? In other words, should a combination safe harbor warning for lead read as follows:

Prop 65 SymbolWARNING: This product can expose you to chemicals including lead and lead compounds, which are known to the State of California to cause cancer, and lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Safe Harbor Warnings for Lead

According to OEHHA, in response to Grimaldi Law’s request for interpretation, the answer is “no.” In providing the combination warning for lead, businesses may use the simpler structure set forth in Section 25603(a)(2)(D), using the term “lead” to identify the chemical both as a carcinogen and as a reproductive toxicant:

Prop 65 SymbolWARNING:  This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Implications of a Combination Warning for Lead

In its response to Grimaldi Law’s request for interpretation, OEHHA also raised its concern about “the concept of providing a cancer warning for lead exposures if those exposures are not expected to exceed the NSRL for lead, which is 15 micrograms per day for oral exposures…  [I]f the exposures are below the NSRL [i.e., the warning level for lead as a carcinogen], then naming lead as a carcinogen in the warning could be misleading.  If the exposures are expected to [be] higher than 15 micrograms per day, then including both endpoints should be fine, but could raise concerns about the reproductive and other effects of such high exposures.”

In this regard, OEHHA’s position reflects a a longstanding gap between how the agency views Proposition 65 warnings and how the regulated community views them. Reading the express terms of the Proposition 65 warning statute, the regulated community views the law as permitting warnings for exposures at levels below the warning levels for the chemical, but requiring warnings if the exposure is above that warning level. Thus, the addition of the cancer endpoint in a combination warning for lead does not necessarily mean that exposures to lead are occurring above 15 micrograms per day.

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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.