Four Steps To Avoid Application of California Prop 65 To Sales of Soft Plastic Automotive Components
Over the last couple of years, California has quietly added a number of phthalates, additives used in soft plastic components, to the Governor's list of substances about which consumers must be warned because the substances allegedly cause cancer or developmental or other reproductive harm (often called "the Proposition 65 List"). The Proposition 65 List now includes such commonly used phthalates as DINP, DIDP, DBP, and DEHP. These substances are frequently found in Plastisol®, gaskets, automotive hoses, vinyl seat covers, steering wheel covers, and many others. Once a substance is added to the list, it is infrequently removed, and not often the subject of intense state enforcement. Instead, the Proposition 65 statute creates an incentive for private attorneys to bring actions as “bounty hunters” collecting 25 percent of the fines assessed when a company fails to warn of dangers allegedly associated with its product.
Now, with an announcement by state enforcers and plaintiffs' attorneys that they intend to focus on a so-called "Dirty Dozen" of the substances on the Proposition 65 List, specifically including phthalates, automotive suppliers can expect to receive Notices of Violation contending that suppliers should have labeled their products with warnings to alert consumers to the alleged dangers of these substances. In fact, some automotive suppliers have already received Notices of Violation from plaintiffs’ attorneys acting as "bounty hunters" and seeking to collect fines for alleged failures to warn about exposure. The following products made specifically for use in an automobile have already been subject to Notices of Violation from private attorney bounty hunters: hand tools with vinyl grips (e.g., an oil filter wrench), seat covers, steering wheel covers, a steering wheel lock, vinyl mats, a glove box envelope, plastic car seat covers, a CD visor organizer and a pneumatic creeper seat
All too often, when faced with the tight statutory time frames within which a response must be made -- sixty days from receipt of a Notice of Violation – not to mention the risk of adverse publicity for their brand, many recipients of such notices buckle under, pay attorneys’ fees and costs (for their own and opposing counsel) and fines, and agree to add warning labels to their products and/or reformulate them to eliminate or reduce the level of the offending substance. Additional costs are then incurred by suppliers with respect to labeling design changes and product sourcing changes in attempts to avoid using Proposition 65-listed substances.
Worse yet, there are new proposed rules pending to require much more specific warning labels that will make this labeling effort even more burdensome, especially when multiple phthalates or other listed substances are included in a finished product.
By planning in advance of receiving a Notice of Violation, most automotive suppliers will find that they can take advantage of the "safe harbor" provisions in the statute by taking the following four steps:
- Determine the applicable Safe Harbor level (either the No Significant Risk Level ("NSRL") for carcinogens or the Maximum Allowable Dose Level (MADL) for developmental and reproductive toxicants) for the phthalate at issue. In some cases, that level has been established by state rulemaking, through the California Office of Environmental Health Hazard Assessment ("OEHHA"). Where an NSRL or MADL has not been established by OEHHA, a recognized toxicologist can be hired for a reasonable fee to derive an NSRL based on a review of the scientific literature related to exposure to that substance. It is important to note that a Safe Harbor level does not equate to a concentration of a phthalate in a product component, but to the maximum amount that the human body can be exposed to on a daily basis without necessitating a warning label for the product.
- Develop an exposure scenario based on installation, extraction and regular use of the product. With respect to phthalates, the exposure risk is generally through dermal absorption, so the exposure scenario should detail how often and for how long a consumer would contact the product, typically by holding or gripping the product with his or her hands. This can be done through the use of a toxicologist or other suitable scientific consultant.
- Using the dermal absorption rate for the product, determine whether the exposure based on dermal absorption exceeds the NSRL. The dermal absorption rate for a given chemical can sometimes be obtained directly from published scientific literature, or, if not, it may require the use of a toxicologist to extrapolate from existing data. For nearly all automotive engine components, dermal contact by a consumer is so infrequent and fleeting that the NSRL should not be exceeded.
- Now keep a file of your reports and calculations in your legal department so that the material is available to be used to rebut any Notice of Violation the company receives. Proposition 65 provides that scientific evidence of compliance with its "safe harbor" provisions is a complete defense to an allegation that consumer warnings should have been provided.
By planning now to meet the requirements of the Proposition 65 "safe harbor" provisions, most automotive suppliers should be able to avoid both the warning label requirements and the vexatious litigation initiated by private attorney "bounty hunters" seeking to cash in on Proposition 65 fines for labeling violations.