Extracted from Law360
On Dec. 29, 2023, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment, or OEHHA, added bisphenol S to the Proposition 65 list of chemicals known to cause reproductive toxicity.
The listing becomes effective on Dec. 29 — one year after the date of listing — which means companies must begin displaying Proposition 65 warnings for bisphenol S, or BPS, within a few weeks, or reformulate products so that no warning is required.
Given the current use of BPS in millions of products, the listing will have sweeping implications for businesses in the retail, food and beverage, pulp and paper, industrial manufacturing, and personal care product industries.
Background on Proposition 65
California's Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act, 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 California to publish a list of these chemicals, which must be updated at least once a year. The list has grown to include approximately 900 chemicals since it was first published in 1987.
Proposition 65 imposes civil penalties for failing to provide notices of up to $2,500 per violation. The statute also provides that any company that "threatens to violate" the warning requirement may be "enjoined in any court of competent jurisdiction."
The California attorney general, any district attorney and certain city attorneys are authorized to enforce Proposition 65. In addition, any individual — even someone who has not suffered harm, or ever used a product at issue — may bring a private enforcement action.
The private enforcer must first serve a 60-day notice of violation on the alleged violator before proceeding to file a lawsuit. These private enforcers take home 25% of all civil penalties imposed as a bounty for their efforts, and their attorneys routinely recover their fees.
These lawsuits often result in settlements, which include civil penalties, attorney fees and injunctive relief — such as displaying Proposition 65-compliant warnings, or agreeing to reformulate a product.
California Places BPS on the Proposition 65 List
The listing of BPS as a reproductive toxicant under Proposition 65 will take effect on Dec. 29. This grace period is intended to give businesses time to evaluate their products and operations to determine whether compliance measures, such as warning labels, are required.
Notably, OEHHA has not yet established a safe harbor level for BPS. A safe harbor level is a threshold below which a business is exempt from Proposition 65 warning requirements. These levels provide clarity and protection for businesses.
Without a safe harbor level to guide them, businesses should assume that private enforcers will serve notices of violation if there is any detectable amount of BPS. The burden would then shift to the alleged violator to prove the product does not require a warning — including through performance of quantitative risk assessments and exposure assessments.
Products That May Contain BPS
BPS is part of polyethersulfone plastic, which is used to make hard plastic items and synthetic fibers for clothing and other textiles. It is a common replacement for bisphenol A in polycarbonate plastics, epoxy resins and thermal paper.
BPS may be found in some of the following categories of products.
Consumer goods:
- Food and beverage containers, including plastic bottles and food and beverage can linings;
- Food utensils;
- Baby bottles, sippy cups and other products marketed for infants and children;
- Packaging for personal care items, such as cosmetics;
- Microwave-safe dishes and containers; and
- Parts of electronics, such as screens for mobile phones and calculators.
Industrial and commercial products:
- Industrial coatings and adhesives;
- Protective linings for metal cans and pipes; and
- Heat-resistant parts in automobile engines, industrial machinery, medical equipment and other applications.
Paper products:
- Cash register receipts;
- Tickets (parking tickets, lottery tickets, etc.);
- Shipping labels; and
- Prescription labels.
Clothing and textile products:
- Sportswear;
- Socks;
- Raingear;
- Blankets;
- Curtains; and
- Furniture upholstery.
Implications for Businesses
Given the widespread use of BPS, businesses across a range of industries need to take action to determine whether their products comply with Proposition 65, assess the need to reformulate or display warnings, evaluate potential affirmative defenses, and determine the risk of private enforcement.
Potential actions businesses may take include the following.
Conducting Product Assessments
Often, companies may not even know if BPS is present in their products — or if it is, how it got there. Review product formulations and materials to identify potential BPS content.
Testing for BPS may be necessary to determine exposure levels. Carefully consider the legal issues when evaluating whether to perform testing.
Evaluating Exposure Scenarios
Without a safe harbor level for BPS, companies face significant compliance challenges.
Work with consultants to perform risk and exposure assessments to determine whether products require Proposition 65 warnings for BPS.
Supply Chain Issues
Assess the supply chain to determine whether any products may contain BPS. Companies may consider requesting supplier certifications, testing and data sheets.
Product Reformulation
Companies may seek to reformulate their products to eliminate BPS to avoid Proposition 65 warnings. They should understand the cost of reformulation, and whether it would require significant changes to manufacturing processes and supply chain agreements.
Companies should not replace BPS with other bisphenols listed on the Proposition 65 list, like bisphenol A.
Product Warnings
If businesses determine a Proposition 65 warning is required, they need to determine the appropriate content of the warning and method of transmission.
OEHHA is updating the Proposition 65 safe harbor warning language, and businesses should stay abreast of these regulatory changes. Businesses may also need to evaluate whether to provide written notification to downstream entities that their products require warnings.
Defense and Indemnification
Ensure your company has contractual protection in the event of litigation, including defense and indemnification provisions in supplier agreements.
The addition of BPS to the Proposition 65 list becomes effective in a few weeks, which will open the floodgates to private enforcement actions. Businesses across industries must act now to evaluate their products, understand their compliance obligations, and mitigate risks associated with this new listing.
With proactive planning, companies can navigate the complexities and uncertainties surrounding this new listing.