OEHHA Proposes Additional Changes to Prop 65 Warning Requirements

On June 13, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to Proposition 65’s warning requirements.  The proposed changes revise proposed amendments to Proposition 65 published in October 2023, discussed in a previous blog post.

If implemented, the June 2024 proposal would revise the October 2023 proposal by:

  • Delaying the required use of the new short-form warning content from two years to three years after the amendments take effect.
  • Abandoning many of the proposed changes for internet purchases and catalogues. For example, the June 2024 proposal removes the October 2023 proposal’s requirement that internet retailers provide a warning on the shipped product (in addition to the online warning already required).
  • Including a 60-day grace period for internet retailers to update their online short-form warnings after they are notified that a product will have new warning content.

A document showing the proposed changes to the October 2023 proposal can be found here.  Comments on the proposed changes are due June 28.

Proposition 65, officially known as the as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses in California to warn customers when products contain chemicals known to the state to cause cancer or reproductive harm.

California Glyphosate Warning Requirement Ruled Unconstitutional Compelled Speech

California’s requirement that glyphosate-containing products display a carcinogen warning violates the First Amendment, a Ninth Circuit Court of Appeals panel ruled in a 2-1 decision on November 7, 2023. The decision in the case Nat’l Assoc. of Wheat Growers v. Bonta affirmed a district court’s summary judgment and injunction against the requirement.

Proposition 65 (known as “Prop 65”) requires that any product intentionally containing a chemical on California’s list of known carcinogens warn customers of the product’s carcinogenicity. Glyphosate, one of the most widely used herbicides and the active ingredient in the weed killer Roundup, was automatically added to the list of Prop 65 carcinogens following a 2015 determination by the International Agency for Research on Cancer that glyphosate is “probably carcinogenic to humans.” Other organizations, such as EPA, have not found that glyphosate poses a risk to humans, however.

According to the court, compelled commercial speech must pass intermediate scrutiny unless it is “purely factual and uncontroversial information,” in which case a lesser level of scrutiny applies. The panel found that this exemption was not applicable because whether glyphosate is carcinogenic is subject to scientific debate. The panel then determined that the labeling requirement did not survive intermediate scrutiny because “warn[ing] consumers of a potential ‘risk’ never confirmed by any regulatory body” does not directly advance California’s interest in preserving public health.

The warning was previously struck down by a California district court on the grounds that its phrasing would be misleading to customers, it was not purely factual and uncontroversial, and a more equivocal warning would likely not comply with Prop 65. In this case, the panel analyzed three new proposed warning messages from California’s Attorney General and another from California’s Office of Environmental Health Hazard Assessment (OEHHA) but concluded that these warnings were also not purely factual and uncontroversial.

Judge Consuelo M. Callahan wrote for the panel and was joined by Judge Patrick J. Bumatay. Writing in the dissent, Judge Mary M. Schroeder argued that, at minimum, the new OEHHA warning should be remanded to the district court. Schroeder argued that the majority applied inappropriate precedent in determining what makes a statement uncontroversial, failed to examine the actual content of the warning, and ignored the fact that EPA’s most recent determination that glyphosate is unlikely to cause cancer was vacated by the Ninth Circuit in Nat. Res. Def. Council v. U.S. Env’t Prot. Agency (2022) because it was not supported by substantial evidence.

OEHHA Proposes Amendments to Prop 65 Warning Requirements

This October, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to the “safe harbor” warning requirements under Proposition 65, the California Law that requires businesses with at least ten employees to provide a “clear and reasonable” warning to customers about exposures to chemicals known to the state of California to cause cancer or reproductive toxicity (officially called the Safe Drinking Water and Toxic Enforcement Act of 1986). The proposed amendments to the safe harbor warning requirements for Proposition 65 (known as “Prop 65”) focus on short-form warnings, provisions for internet and catalog purchases, and warnings for motor vehicles and recreational marine vessel parts.

Requirement of chemical identification in short-form warnings

Under regulations adopted in 2016, safe harbor warnings generally require the name of at least one chemical for each health effect covered by the label. However, because small products may not have space for a full-length warning, OEHHA included an optional short-form label that does not require businesses to identify the chemical(s) prompting the warning. However, since the adoption of the regulations, OEHHA has found that many businesses have chosen to use the short-form label regardless of product size. OEHHA also found that some businesses use short-form labels in situations where there is no risk of exposure to a Prop 65 chemical as a litigation avoidance strategy, diluting the impact of legitimate warnings. As a result, OEHHA proposes that short-form labels identify a chemical for each health effect covered by the label beginning two years after the rule’s effective date.

Provisions for internet and catalog purchases

OEHHA is aware of confusion among businesses about how to provide warnings for products purchased online. For example, some businesses have expressed confusion as to whether an online warning is necessary if the product has a warning on its label and vice versa. To clarify, OEHHA proposes that warnings be required both online and on the product label, or in the case of a catalog, both in the catalog and on the product. OEHHA additionally clarifies the requirements for online warnings; a business must include either a warning on the product display page, a hyperlink on the product display page using the word “WARNING” that links to the warning, or an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.

Warnings for motor vehicles and recreational marine vessel parts

OEHHA states that passenger and off-highway motor vehicles and recreational marine vessel parts present a unique challenge because parts are often too small to comfortably fit full-length warnings and because consumer exposure varies substantially from person to person. To address these concerns, OEHHA proposes that businesses selling these parts can choose to provide a general exposure warning (either at each retail point of sale or point of display) in lieu of a warning on the product label.

Other proposed revisions include explicitly allowing the use of short-form warnings on food products, allowing warnings to begin with “CA” or “CALIFORNIA WARNING” instead of just “WARNING,” allowing more flexibility for warning font sizes and adding additional language to clarify that warnings be placed conspicuously.

The proposed amendments are similar to amendments proposed by OEHHA in January 2021. OEHHA was unable to complete that rulemaking within the regulatory time limit. The current proposal is the first on safe harbor warning requirements since that time.

Comments on the proposed amendments are due December 20, 2023. In addition, OEHHA will hold a hybrid public hearing on the proposed amendments on December 13, 2023, at 10:00 AM PST.

California Governor Vetoes Three Bills Restricting PFAS in Consumer Products

On October 8, 2023, California Governor Gavin Newsom announced that he had vetoed three bills passed by California’s state legislature designed to restrict PFAS in certain consumer products. The three bills vetoed by Newsom are as follows:

  • AB 727, which would have banned the manufacture and sale of cleaning products containing intentionally added PFAS or PFAS at or above a certain concentration beginning in 2026. The concentration threshold would have decreased over time to 10 ppm in 2028.  The bill also would have banned the manufacture and sale of floor sealers and floor finishers containing intentionally added PFAS or PFAS at or above 10 ppm beginning in 2028.
  • AB 246, which would have banned the manufacture and sale of menstrual products containing intentionally added PFAS or PFAS at or above 10 ppm beginning in 2025.
  • AB 1423, which would have banned the manufacture, sale, or purchase of artificial turf containing intentionally added PFAS or PFAS at or above 20 ppm beginning in 2026.

In his veto messages for each of the three bills, Newsom provided an identical rationale for his decision.  Newsom wrote that he “strongly support[s] the author’s intent and [has] signed similar legislation in the past” but is concerned that the bill does not identify a regulatory agency to determine or enforce compliance with the proposed statute. According to Newsom, similar legislation that has been enacted without regulatory oversight has been challenging to implement due to inconsistent interpretations and confusion among manufacturers on how to comply. Newsom concluded each message by stating that he is directing the Department of Toxic Substances Control to work with the bill’s author and the legislature to consider other approaches to PFAS regulation.

Microplastics and PPD Derivatives Proposed for Regulation in California

California state regulators recently announced plans to potentially regulate two additional groups of chemicals under the state’s Safer Consumer Products Program (“SCP”). The California Department of Toxic Substances Control (“DTSC”) has proposed adding microplastics and para-Phenylenediamine (“PPD”) derivatives to its Candidate Chemicals List (“CCL”) due to their reported impacts on human health and the environment. Regulators are beginning a public comment process in the hopes of gathering valuable input and feedback from stakeholders to help inform a potential regulatory proposal.

Scientific evidence has been growing regarding the harmful effects of microplastics on both human health and the environment. These minuscule plastic particles, released directly or through the breakdown of larger plastic items, persist and spread throughout the ecosystem. DTSC detailed this issue and identified products that release microplastics into the environment as one of their top five policy priorities in the 2021-2023 Priority Product Work Plan.

PPD derivatives, a family of chemicals widely used in various industrial applications, have also come under scrutiny. Specifically, 6PPD, a member of the PPD derivative family, is extensively used in motor vehicle tires to prevent degradation over time. DTSC is finalizing regulations to include motor vehicle tires containing 6PPD on its Priority Product List. This regulation will require tire manufacturers to identify and assess potential alternatives to 6PPD that ensure tire safety and performance. By adding the entire PPD derivative class to the CCL, manufacturers will be prompted to thoroughly evaluate the tradeoffs involved before switching from 6PPD to another PPD derivative.

Adding chemicals to the CCL does not automatically impose new requirements. Instead, it enables the SCP Program to select consumer products containing these chemicals for evaluation and potential regulation as Chemicals of Concern in Priority Products.

Public workshops are scheduled for June and July, providing an opportunity for interested parties to contribute to the discussion and share their expertise. Information on the upcoming workshops can be found here.

New Study Finds Multiple Toxic Chemicals in Consumer Products

This May, the American Chemical Society published a new study evaluating the presence of toxic chemicals in consumer products.  The study found use of at least one chemical known to the state of California to cause cancer, reproductive issues, and/or developmental issues in over one hundred types of consumer products.

The study’s authors used data from the California Air Resources Board’s (CARB) Consumer Product Regulatory Program, which collects data on volatile organic compounds (VOCs) in California consumer products.  They then cross-referenced this data against the list of harmful chemicals regulated under California’s Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65 or Prop 65, to determine the hazards posed by each product category.  It should be emphasized that the study provides only a partial picture of the use of hazardous chemicals in consumer products; only about 200 of the 865 Prop 65-listed substances are VOCs.

More than 100 product categories contained at least one VOC chemical listed under Prop 65 (a “listed chemical”).  Consumers were exposed to the greatest number of listed chemicals in categories that included personal care products, cleaners, and household products; for workers, adhesives had the greatest number of listed chemicals.  The study also determined that more than 5,000 tons of listed chemicals were released from California consumer products in 2020.

In general, the product categories with the most listed chemicals were also the categories in which exposures to especially hazardous listed chemicals were highest.  After comparing the product categories with the highest numbers especially hazardous chemicals with the categories with the highest potential exposures, the researchers assembled a list of 30 product categories and 11 especially hazardous chemicals—including formaldehyde and methylene chloride—that they believed should be prioritized for regulation.

In addition, the study noted that certain occupations put workers at particular risk of exposure to listed chemicals.  For example, janitors could be exposed to five prioritized product categories, including cleaners, detergents, and degreasers.  Construction workers, nail/hair salon employees, and automobile maintenance/repair workers were also described as particularly at-risk.

Because CARB only makes data available by product category, the study did not identify particular brands or products in their analysis.

California Department of Toxic Substances Hosted Engagement Sessions on Sustainable Chemistry Definition

The California Department of Toxic Substances Control (CDTSC) hosted two engagement sessions encouraging stakeholders to share their perspectives on an actionable definition of sustainable chemistry that was provided by the Expert Committee on Sustainable Chemistry (ECOSChem). ECOSChem is a 20-person group including representatives from academia, government, industry, and non-governmental organizations.  The group has been tasked with establishing “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.”

In its draft, ECOSChem defined sustainable chemistry as “the practice and application of chemistry that eliminates negative impacts to humans and ecosystems, as well as benefits current and future generations.” The definition was drafted with five criteria in mind (1) health and safety through hazard elimination, (2) climate and ecosystem impacts, (3) circularity, (4) equity and justice, and (5) transparency. In addition to the definition, , ECOSChem provided the following indicators of what sustainable chemistry will look like:

A sustainable chemical, material, process, or product will…

  • Eliminate all associated hazards and hazardous emissions to all people and ecosystems across its existence.
  • Not result in releases, including releases of byproducts or breakdown products, that negatively persist or bioaccumulate.
  • Eliminate impacts on climate and biodiversity by utilizing earth-abundant, non-toxic chemical building blocks that minimize habitat and resource degradation, greenhouse gas emissions, carbon footprints, and energy consumption, including for transportation and distribution.
  • Be designed to have [a] lifetime appropriate for its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy conservation and reclamation, reduce consumption of finite resources, and waste prevention, minimization, and elimination.
  • Be designed such that all associated negative social impacts are eliminated.
  • Be made or implemented to prioritize the remediation of harms for communities and societies that have been disproportionately impacted by traditional chemistries, chemicals, and chemical processes, and/or support the needs of workers, marginalized groups (e.g., immigrant communities, and communities of color), and vulnerable groups (e.g., pregnant women and children).
  • Be made or implemented in a way that does not create new problems or shift harm to other communities or societies.
  • Have had its health, safety, and environmental data disclosed in an accessible format to individuals, workers, communities, policymakers, and the public.
  • Use independent, third-party systems to verify sustainability, health, safety, and other claims. The sources for verification should be openly accessible.

ECOSChem members will use the feedback received at the meeting to revise the definition to ensure that the language is clear and actionable.





California Issues Expanded Draft Priority Product Workplan

The California Department of Toxic Substances Control (DTSC) recently issued a Draft Three-Year Priority Product Work Plan (2018-2020) under the state Safer Consumer Products program (also known as the “green chemistry” program). The draft Work Plan would supersede the current plan adopted in 2015, and lists the categories of products that DTSC intends to investigate under the program for the next three years. Public comments on the draft Work Plan will be accepted until March 9.

The new draft Work Plan includes seven product categories. Five were carried over from the prior Work Plan: (1) beauty, personal care and hygiene products; (2) cleaning products; (3) household, school and workplace furnishings; (4) building products and materials used in construction and renovation; (5) consumable office, school, and business supplies. The two new categories proposed are food packaging and lead acid batteries.

The Work Plan does not specifically identify any product as a regulatory priority, but identifies categories from which DTSC will propose future priority products. DTSC is limited to regulation of products within these categories, except for other products identified by legislation, Executive Order or a petition to DTSC that has been granted.

In investigating potential priority products, DTSC intends to solicit information from manufacturers and their supply chain partners as well as trade associations and others with relevant expertise. They also may make targeted information requests to specific industry sectors; gather information through public workshops and comment periods; and issue “information call ins” as described in the state regulations. This information would be available to the public except for trade secrets protected by the regulations. DTSC expects to engage in discussion with industry experts about product formulations, supply chain considerations, and industrial toxicology studies among other topics that can expand and refine their knowledge for the purposes of selecting priority products.

Draft Alternatives Analysis Guide released for California’s Safer Consumer Products program.

On Monday, the California Department of Toxic Substances Control (DTSC) released a draft version of its Alternatives Analysis Guide, a document that will be critical to the implementation of the state’s Safer Consumer Products (SCP) program. Once finalized, the Guide will provide a framework and steps to help responsible entities (the manufacturers, importers, assemblers, and retailers of designated “Priority Products”) conduct an “Alternatives Analysis,” as required by the SCP regulations.

Under the SCP program, each Alternatives Analysis will look at how to best limit or prevent potential harm from the potentially hazardous “Candidate Chemical” in Priority Products. Every Alternatives Analysis must consider important impacts of the product throughout its life cycle and provide for specific actions to make the product safer.

After receiving and approving a final Alternatives Analysis report, DTSC will implement Regulatory Responses which favor the safest feasible alternatives. These actions may take the form of enforceable orders or agreements requiring further manufacturer research, additional information to DTSC or consumers, product redesign, end-of-life product stewardship, or sales restrictions or prohibition.

The draft Alternatives Analysis Guide provides information about the general process of conducting an Alternatives Analysis and is meant to be a “resource book” for people preparing Alternatives Analyses. The Guide provides methods, tools, information sources, and “best practice approaches” for conducting an Alternatives Analysis, and is expected to be updated periodically. The Guide is not a “regulatory document” or standard, nor is it meant to be used as a checklist.

In September 2015, DTSC released a Draft Stage 1 Alternatives Analysis Guide and scheduled the release of Stage 2 guidance for 2016. Stage 1 of the Alternatives Analysis process will begin with identifying product requirements and chemicals of concern, alternatives, and factors for comparing alternatives. Then, responsible entities will conduct an initial evaluation and screening of alternative replacement chemicals. Stage 1 culminates in the submission to DTSC of the Preliminary Alternatives Analysis Report, including a Work Plan.

After the preliminary report is approved, Stage 2 begins with executing the Work Plan and conducting an in-depth analysis that includes life cycle and economic effects. After an iterative evaluation and comparison process, the responsible entity will select an alternative, based on the information and conclusions generated through the comparative analysis, and recommends a regulatory response. Finally, the responsible entity must submit a Final Alternatives Analysis Report, including an implementation plan and timeline, if applicable. This final report will be available for public review and comment before DTSC makes any determination about regulatory responses.

The draft Guide released this week covers both stages of the Alternatives Analysis process. New chapters of the draft Alternative Analysis Guide, addressing the steps in Stage 2, are as follows:

  • Exposure
  • Life Cycle Impacts
  • Economic Impacts
  • Informational Needs
  • Selection of Alternatives
  • Self-Evaluation

DTSC is accepting public comments on the draft Alternatives Analysis Guide through January 20, 2017. The agency has also scheduled a public webinar to present and discuss the draft on January 10, 2017.

California’s Department of Toxic Substances Control is Seeking Collaboration on the Next Round of Products

The Safer Consumer Products (SCP) program, under CA’s Department of Toxic Substances Control (DTSC), is using a four-step process to reduce toxic chemicals in products that consumers buy and use. One of these steps includes developing Priority Products, which are products that contain one or more Candidate Chemicals. The DTSC is now seeking stakeholder engagement for implementing its Priority Product Work Plan (PPWP) in a webinar, scheduled for November 15. 2016 from 10:30am- 12:00pm PST.

The webinar will provide an overview of DTSC’s progress towards Priority Product selection. The webinar will also focus on three topics, which the DTSC would like stakeholder engagement in:

  • Potential aquatic impacts and continued uses of nonylphenol ethoxylates (NPEs) and triclosan,
  • Nail products, and
  • Perfluoroalkyl and polyfluoroalkyl substances (PFASS) in carpets, rugs, upholstered furniture, and their care and treatment products.

Potential Aquatic Impacts and Continued Uses of Nonylphenol Ethoxylates and Triclosan:

This category contains chemicals that may adversely impact aquatic resources, or that have been observed through water quality monitoring. SCP identified NPEs, triclosan, and some of their transformation products as Candidate Chemicals that may warrant further research. A Candidate Chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is either: 1) found on one or more of the authoritative lists specified in Section 69502.2(a) of the regulations; or 2) listed by DTSC using the criteria specified in Section 69502.2(b). SCP would like to better understand the presence of these Candidate Chemicals in the aquatic environment, and would like current product use information for these Candidate Chemicals in cleaning, personal care, and clothing products.

Nail Products:

Nail salon workers have daily exposure to a variety of hazardous chemicals in nail products. Additionally, nail products in salons and at home are used by potentially sensitive subpopulations such as pregnant women and children. Three key questions being explored for this topic are:

  • What are the potentially hazardous chemicals present in nail products?
  • Why are these potentially hazardous chemicals being used in nail products?
  • What alternative chemicals are being used including products marketed as green, safer, or free of specific chemicals?

PFASS in Carpets, Rugs, Upholstered Furniture, and Their Care and Treatment Products:

DTSC is concerned about the hazard traits of PFASs and their widespread presence in the environment, humans, and other living organisms. Carpets, rugs, and upholstered furniture treated with PFASs for stain-, soil-, oil-, or water-resistance, as well as their PFASs-based care and treatment products, are potential long-term sources of widespread human and ecological exposures to this class of chemicals. DTSC is requesting public input to better understand:

  • The exposure potential from the use of PFASs in these consumer products, and
  • The hazard traits of short-chain PFASs, fluorinated ethers, and other “novel” PFASs.