Managing Chemicals of Concern Beyond PFAS

How are state regulations reshaping chemical compliance for product manufacturers?

Manufacturers face a fast-changing patchwork of federal and state chemical requirements that are reshaping product development, material selection, supply chains, market access, and long-term product viability. While the Toxic Substances Control Act (TSCA) remains a cornerstone of federal chemical regulation, state regulations and programs add complexity to the compliance landscape and increasingly drive chemical policy and product restrictions through distinct priorities, timelines, and compliance obligations.

Rather than evaluating individual substances one at a time, some recent state requirements regulate per- and polyfluoroalkyl substances (PFAS) and other chemicals as broad classes, as well as regulating their use in entire product categories. Similar approaches are emerging for bisphenols, phthalates, flame retardants, and microplastics, as chemicals-of-concern lists continue to grow. 

Public attention has helped drive a number of states to adopt such class-based chemical restrictions quickly. Many of these state requirements identify candidate and priority chemicals largely through hazard identification or classification, sometimes with less emphasis on exposure-based risk evaluations. In these cases, regulators are often acting before the scientific community has reached consensus on potential environmental or health impacts of these chemicals, prompting manufacturers to evaluate more substances across more products and jurisdictions before analytical methods or viable alternatives have fully developed.

The uncertainties created by the pace of regulatory change have implications that extend across the entire product lifecycle, from manufacturing and packaging to consumer use and end-of-life management. Addressing these implications calls for greater visibility across product lines and a more structured approach to evaluation, substitution, and documentation. Identifying suitable alternatives may also require balancing multiple regulatory requirements across product categories and jurisdictions. In some cases, commercially available alternatives may not satisfy all applicable performance, supply-chain, safety, sustainability, and regulatory objectives simultaneously.

From regulating individual chemicals to regulating broader chemical classes

Broad class-based chemical restrictions pose special challenges around defining and understanding what constitutes a class. Even when a particular substance is well understood, other chemicals grouped within the same "class" may not necessarily exhibit the same structure-property relationships, complicating decisions about reformulation, substitution, and long-term compliance. Two gaps are especially important.

The first gap is evidentiary. Regulatory classifications and product-specific restrictions are advancing even as the scientific community's understanding of the properties and behaviors of individual substances emerges or continues to develop. For example, discussions surrounding the presence of trifluoroacetic acid in the environment have resulted in new chemical classifications and regulatory obligations that rely on characteristics such as persistence and mobility alone, before a robust understanding of the chemical's potential human health effects has been established. Additionally, inconsistent interpretations of the relevance and significance of the toxicology data have resulted in varying classifications by regulatory bodies. 

The second gap is analytical. Reporting requirements, concentration limits, and testing expectations may emerge before fit-for-purpose analytical methods are developed, validated, or standardized. Manufacturers may face compliance obligations tied to evolving analytical methods while also evaluating technically viable alternatives. 

These limitations can complicate interpretation, enforcement, and compliance. Reporting thresholds or concentration limits may take effect before testing methods and reporting expectations are refined and standardized, making it hard for manufacturers to evaluate their materials, compare results with those provided by suppliers, or consistently demonstrate compliance. Exposure modeling, realistic-use assessments, and evaluations of technically viable alternatives may also lag behind regulatory timelines. These gaps can make lasting implementation difficult, but they do not preclude government action.

Moving from a reactive to a strategic, structured response

When new restrictions are introduced, manufacturers may have limited time to gather information from their supply chains, qualify alternative substances or materials, reformulate or reengineer products, validate performance, and update manufacturing processes. The primary business risk is not the reformulation itself but the potential that replacement decisions must be made before sufficient information is available, increasing the likelihood that an alternative introduces new technical, performance, environmental, exposure, or compliance concerns that were not identified during the initial evaluation.

Selecting an alternative material may involve more than a simple substitution of one ingredient or material for another (i.e., a direct replacement). Formulators may need to use multiple substances or materials to achieve the same performance or longevity, in addition to evaluating new suppliers and availability, raw material composition, manufacturing compatibility, waste-stream impacts, future compliance, and the potential for unexpected contaminants or byproducts in the substitute material or manufacturing method. In some cases, a direct substitution cannot be found with alternative materials, and more extensive reengineering of the product may be required.

National distribution demands for products can further complicate a manufacturer's strategy decisions. Consumer products companies may find themselves designing materials and formulations to satisfy the strictest state obligations because maintaining multiple formulations for individual jurisdictions is impractical. This approach can disrupt supply chains and increase testing, documentation, and reformulation costs, with disproportionate impacts for smaller companies.

A more strategic response can include several core practices:

• Chemical inventory visibility across product lines. Effective programs account for substances in products, components, manufacturing processes, recycled inputs, and supplier materials as they evolve, reducing the need to start from scratch when new regulatory requirements surface.
• Exposure-based evaluation aligned to realistic use conditions. Understanding how products are actually used provides important context when evaluating potential concerns.
• Fit-for-purpose analytical validation before interpreting results. Analytical data is most informative when supported by validated methods that are appropriate to the intended decision.
• Formal substitution governance. Replacement decisions can be evaluated systematically to reduce the risk of regrettable substitutions and unintended consequences and track how decisions evolved over time. Having these records can help prevent companies from backtracking on a prior decision to satisfy a regulation that impacts compliance with newer requirements.
• Ongoing regulatory horizon monitoring. Emerging state programs can create new obligations long before final regulations take effect. Maintaining visibility into evolving compliance requirements provides critical time to make better, more informed product decisions. 
• Lifecycle and end-of-life evaluation. Assessments can consider how materials may change during use, recycling, disposal, or secondary applications, particularly as regulations increasingly consider impacts beyond the point of sale.
• Documentation that supports enforcement and litigation resilience. Clear records of evaluations, testing strategies, and supporting rationale can strengthen both compliance and legal preparedness.

Building durable chemical management strategies

As the regulatory landscape that emerged with PFAS increasingly shapes regulatory strategies and approaches used to manage other chemicals of concern, manufacturers that establish repeatable processes for interpreting new rules, evaluating emerging science, validating analytical methods, and governing substitutions may be better positioned to respond across products and jurisdictions. Clear documentation and stakeholder communication can also provide meaningful competitive advantages, helping organizations explain the scientific basis for their choices and preserve flexibility as policies change.