CA’s Proposition 65 Safe-Harbor Level Adds Clarity for Businesses

The California Office of Environmental Health Hazard Assessment in August proposed adding a “no significant risk level” benchmark under Proposition 65 for diethanolamine (DEA), a chemical widely used in products such as cosmetics, shampoos, hair conditioners, and liquid laundry and dishwashing detergents.

If adopted, the NSRL will provide a safe-harbor level for exposures under which a business is exempt from displaying California’s Proposition 65 warnings.

The NSRL would provide clarity and practical negotiating tools for companies addressing notices of violation, settlements, and litigation—particularly for cosmetic manufacturers that have faced a surge of Proposition 65 notices relating to DEA—while also creating technical issues that companies should address proactively.

The public comment period is open through Nov. 7. After the comment period closes, OEHHA may revise the proposal and then proceed toward adoption or not.

Proposition 65

Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings before exposing individuals to chemicals known to the state of California to cause cancer, birth defects, or reproductive harm. Proposition 65 requires OEHHA, the lead state agency responsible for the statute’s implementation, to publish a list of these chemicals.

The Proposition 65 list must be updated at least once a year and has grown to include approximately 900 chemicals since it was first published in 1987.

Proposition 65 imposes civil penalties of up to $2,500 per violation. It also provides that any company that “threatens to violate” the warning requirement may be “enjoined in any court of competent jurisdiction.”

Proposition 65 warnings aren’t required when exposures to a listed chemical don’t pose a significant risk. OEHHA publishes NSRLs for certain carcinogens that function as safe-harbor levels.

These safe harbors provide assurance to the regulated community that exposures at or below the NSRL aren’t considered to pose a significant risk of cancer and are exempt from Proposition 65’s warning requirement. However, businesses aren’t required to rely on a safe-harbor level to demonstrate that their product is exempt from the warning requirement.

Recent Enforcement

DEA was listed on June 22, 2012, as a Proposition 65 carcinogen. Since then, private enforcers have served more than 1,400 notices of violation for cosmetics containing the chemical. But the number of notices surged in 2023, and since January 2023, there have been more than 1,300 notices of violation for DEA in cosmetics, resulting in dozens of lawsuits.

Without a regulatory safe-harbor level for DEA, businesses have the burden to establish that anticipated exposure levels won’t pose a significant risk of cancer. Although OEHHA has adopted regulations that provide guidance, it can be expensive for businesses to calculate their own levels.

OEHHA has proposed an NSRL of 6.4 micrograms/day (µg/day) for DEA, which applies to dermal exposures only, so businesses with products that may cause exposures to DEA through inhalation or ingestion must determine the level at which the exposure doesn’t cause a significant risk of cancer. However, dermal exposure is a common route of exposure for DEA, and OEHHA expects the NSRL to be valuable for most businesses with products containing this chemical.

Impact on Litigation

The proposed NSRL for DEA can provide clarity for businesses facing an onslaught of private enforcement activity. To date, businesses have been operating in the dark—or forced to work with experts—in determining the appropriate level below which a product requires a warning.

If OEHHA adopts the NSRL, products that result in dermal exposures ≤ 6.4 µg/day wouldn’t require a Proposition 65 warning for that route of exposure. That may result in fewer notices of violation for DEA, because many products will not exceed 6.4 µg/day threshold, and provide stronger statutory exposure exemption defenses for pending lawsuits and active notices of violation if companies can show their products don’t result in an exposure that exceeds the NSRL.

Formal safe-harbor levels will also be helpful for companies negotiating settlements. Until now, settlements have set varying reformulation levels for DEA, and an official NSRL could help provide uniformity by establishing a presumptively defensible level.

Compliance Considerations

If the safe harbor is finalized, companies should assess which product lines are likely to contain DEA and review formulation specifications and supplier certifications. The next step would be to consider whether to reformulate to remove DEA (when economically feasible), collect concentration testing, and perform dermal exposure estimates using realistic use scenarios consistent with OEHHA methods to document exposures ≤ 6.4 µg/day, or display warnings when exposures are plausibly higher.

A compliance strategy that uses OEHHA’s NSRL can reduce litigation exposure but still requires factual support.

Bottom Line

OEHHA’s proposed NSRL for DEA is a material development that may offer a new, government-adopted safe harbor businesses can rely on, but it’s route-limited (dermal only) and optional. Even if the NSRL is adopted, careful due diligence will be necessary to show your products fall at or below the level.

If OEHHA’s toxicological assumptions or modeling choices are flawed for your industry or products, consider submitting technical comments to OEHHA before the Nov. 7 deadline to request adjustments or clarifications.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law, Bloomberg Tax, and Bloomberg Government, or its owners.

Author Information

Gregory Berlin is a partner in the environment, land use & natural resources group at Alston & Bird.

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