Just because a chemical is listed on the Prop 65 list doesn’t mean it is illegal to have the chemical in a product without a warning. OEHHA has developed “safe harbor” levels for roughly 300 of the more than 800 chemicals on the Prop 65 list. If the product exposes an individual to a chemical at a level below the maximum threshold for safety, there can be no liability for failure to provide a warning.
No Significant Risk Level for carcinogens
For substances that have been identified as causing cancer, the “no significant risk level” (“NSRL”) means that exposure to the amount of chemical in a product would result in no more than one case of cancer out of every 100,000 individuals who were exposed to the chemical over a 70-year time period. One notable carcinogen for which OEHHA has developed a safe harbor level is lead.
Maximum Allowable Dose Levels for reproductive toxins
Safe harbor levels for chemicals identified as causing birth defects or other reproductive harm are determined by first identifying the level of exposure that does not pose any harm to humans or lab test animals (the “NOEL”). The NOEL is then divided by 1,000 to provide the appropriate safety margin.
Put another way, the “maximum allowable dose level” (“MADL”) is the level at which a chemical would have no observable effect, even if an individual were exposed to 1,000 times that level. Among others, OEHHA provides MADLs for toluene and methanol.
Chemicals with no OEHHA safe harbor levels
What about the chemicals that OEHHA doesn’t set safe harbor levels for (the vast majority identified on the Prop 65 list)?
Unfortunately, at least for defendants, the burden falls on them to establish that any listed chemicals in the products do not pose any risk. For chemicals without a safe harbor level, defendants must establish the NSRL or the MADL.
Defendants must prove any exposure below safe harbor levels
At first glance, it may seem that very low levels of listed chemicals in products isolate defendants from lawsuits (especially when it is a chemical for which OEHHA has expressly set safe harbor levels). Not so.
A plaintiff may bring a Prop 65 lawsuit if they can demonstrate exposure to any amount of a listed chemical in a product, no matter how small. All the plaintiff need do is show that there is some exposure to a listed chemical in a product with no warning, and then the burden falls on the defendant to prove that the amount of chemical is below either the NSRL or MADL. This is typically established by costly expert analysis, in which experts run exposure assessments to see how much exposure to a chemical occurs through typical use of the product, with measurements of exposure through dermal, ingestion or inhalation of the chemical.
Considering this easy burden shift, the safe harbor levels are cold comfort to defendants, since defendants still bear the cost of demonstrating levels are not exceeded. Depending on the amount of expert time necessary to show exposure is below the safe harbor level (not to mention all the other litigation activities like motion practice and discovery that must occur before expert testimony can even be presented), these costs will almost certainly exceed whatever amount plaintiffs demand in settlement.