How East Fork Enterprises, Inc. v. EPA Dismantled the "Whole Chemical" Approach and Reshaped State Preemption

Executive Summary

The Fifth Circuit’s September 15, 2026, decision in East Fork Enterprises, Inc. v. EPA rejects EPA’s “whole chemical” approach to risk determinations and requires separate unreasonable-risk determinations for each of the conditions of use EPA evaluates during the risk evaluation process. In practical terms, the condition of use—not the chemical undergoing review—becomes the relevant legal benchmark.

The shift from a “whole chemical” approach impacts numerous aspects of the risk evaluation process. Moving forward, impacts include changes to the structure of risk evaluations, the evidentiary record for individual uses, the tailoring of § 6(a) risk-management rules, the availability of § 6(i) no-unreasonable-risk determinations, opportunities for judicial review, and the preemptive effect of federal action under § 18. 

I. Practical Impacts of “Use-by-Use” Approach to Risk Determinations

The departure from the whole chemical approach in the East Fork decision has many potential impacts on EPA’s approach to risk evaluation and risk management.

1. Different Uses of the Same Chemical May Produce Different Legal Outcomes

EPA may determine that some conditions of use present unreasonable risk while other conditions of use do not. Under a “use-by-use” approach, a chemical does not receive a single overarching legal characterization. Instead, industrial, commercial, consumer, processing, disposal, or other evaluated conditions of use may proceed along different statutory paths depending on the risk determination for each use.

2. Targeted § 6(i) No-Unreasonable-Risk Determinations

When EPA concludes that a particular condition of use does not present unreasonable risk, § 6(i) supplies a vehicle for an affirmative federal determination. A “use-by-use” approach might make § 6(i) more important and may result in more discrete no-unreasonable-risk determinations for uses over time.

3. Narrowly Tailored § 6(a) Risk Management

For conditions of use that do present unreasonable risk, EPA’s § 6(a) response should be linked to the particular condition of use contributing to the unreasonable risk and the evidence supporting that determination. The “use-by-use” approach makes it harder to justify a chemical-wide restriction based on risks arising from only a subset of uses and strengthens the argument that restrictions should not be broader than necessary to address the identified unreasonable risk.

4. More Granular Administrative Record

The evidence concerning one condition of use cannot automatically establish the regulatory status of every other use. Therefore, EPA’s administrative record will need to support how the Agency arrived at its risk determinations as it relates to PESS, exposure routes, magnitude and duration of exposure, workplace or consumer circumstances, controls, and other use-specific facts the Agency considered. The resulting risk evaluations might take longer and be more administratively demanding, but they should also make the basis for each determination better supported and legally defensible.

5. More Opportunities for Judicial Review

Condition of use-specific determinations create more focused issues for judicial review. A challenger can address whether substantial evidence supports EPA’s risk conclusion for a particular condition of use, whether EPA considered relevant exposure controls and contrary evidence, and whether the resulting risk-management measure fits the use-specific risk. At the same time, multiple individual risk determinations may create additional litigation points and procedural complexity. EPA should consider issuing a single § 6(i) order for each risk evaluation under the “use-by-use” approach.

6. Greater Regulatory Certainty 

A well-controlled or comparatively low-exposure use is less likely to be swept into the legal consequences of risks arising from materially different uses. An affirmative no-unreasonable-risk determination can provide greater federal certainty for the evaluated condition of use, subject to the exact terms and scope of EPA’s determination and TSCA’s other provisions.

7. Program-Wide Reconsideration Issues

If the finalized or pending EPA risk evaluation actions rely on a whole-chemical approach unreasonable-risk determination, EPA may need to consider whether the underlying evaluation and resulting risk-management action adequately contain separate condition-of-use determinations. The extent of any required revision will depend on the procedural posture, record, and scope of the individual action.

8. Administrative Complexity and Timing

The “use-by-use” approach can turn a risk evaluation into a matrix of separate determinations rather than a single conclusion. This approach improves analytical clarity but may increase the work required to develop, explain, finalize, and defend the evaluation and any resulting rule.

II. Preemption Implications of the “Use-by-Use” Approach

Federal preemption under TSCA is necessary to ensure a uniform approach to chemical management nationwide. TSCA § 18(a)(1)(B) governs federal preemption of state and local laws regulating chemical substances following federal action under § 6. Specifically, states are prohibited from establishing or enforcing laws restricting the manufacture, processing, or distribution of a substance when EPA has made a finding of no unreasonable risk or has implemented risk management rules. For purposes of preemption, two potential outcomes from the “use-by-use” approach are especially relevant:

• No unreasonable risk determination → EPA makes the determination described in § 6(i)(1)
• Unreasonable risk determination → EPA promulgates a final risk-management rule under § 6(a)

A key takeaway is that state preemption is tied to the scope of EPA’s risk evaluation and subsequent action under § 6. A risk evaluation under the “use-by-use” approach can have consequences for preemption on both sides of the unreasonable-risk determination, not just when EPA affirmatively restricts a use.

1. How the “Whole Chemical” Approach Created a Preemption Problem

Under a “whole chemical” approach, EPA could characterize the entire chemical as presenting an unreasonable risk even though particular conditions of use were not found to present unreasonable risk. The “whole chemical” approach also impacts the legal treatment of uses that EPA’s own analysis did not identify as presenting unreasonable risk and potentially deprive the regulated community the clarity associated with a discrete § 6(i) determination.

The “use-by-use” approach is different. Conditions of use presenting unreasonable risk can proceed to § 6(a) risk management, while conditions found not to present unreasonable risk can be addressed through the § 6(i) order. This gives legal significance to both categories and aligns the risk determination more closely with the preemption structure in § 18. 

By treating a chemical as a whole rather than considering the discrete uses, EPA deprived industry of regulatory certainty by allowing the potential continuation of a patchwork of state rules. EPA’s whole-chemical approach effectively nullified TSCA’s new provision under which a no-unreasonable-risk determination would preempt state regulation of the same conditions of use. Furthermore, during the delay between the risk evaluation and final risk management stages, states were able to ban, restrict, or mandate warning for the chemicals, creating more confusion and fragmentation in the regulatory structure.

2. Why § 6(i) May Be the Most Important Preemption Mechanism

Following a determination that a condition of use federal conclusion does not present unreasonable risk, Section 6(i) provides a mechanism for an affirmative federal determination, and § 18 expressly addresses preemption associated with such determinations, subject to statutory limitations.

3. Scope is the Critical Limiting Principle

The completion of a risk evaluation does not preempt all state regulation of the chemical. Rather, a preemption analysis must focus on the relevant scope of EPA’s risk evaluation, risk determination, and risk-management action. Because federal preemption depends on EPA’s risk determination, the risk evaluation should list any condition of use (COU) deemed irrelevant or inapplicable as presenting no unreasonable risk to preserve preemption coverage because an unlisted COU would then fall outside the scope of federal preemption. The precise condition of use, exposed population, activity, and restriction at issue may all matter when comparing state and federal requirements. Accordingly, a defensible analysis should identify the condition of use EPA evaluated, the risk determination for that use, the scope and legal status of any § 6(i) determination or § 6(a) rule, and the relationship between the state requirement and the federal action.

III. Practical Framework for a State Law Preemption Analysis

Listed below are steps to analyze state preemption from EPA’s risk evaluations under a “use-by-use” approach to risk determination:  

• Identify the precise condition of use, activity, product, and population covered by the state restriction.
• Determine whether EPA included that condition of use within the relevant § 6 risk evaluation.
• Identify EPA’s separate risk determination for that condition of use.
• If EPA found no unreasonable risk, identify the pertinent § 6(i) determination and its scope.
• If EPA found unreasonable risk, identify the effective § 6(a) requirements and the uses to which they apply.
• Compare the state restriction with the federal scope rather than assuming chemical-wide preemption.
• Confirm the effective dates and procedural status of the federal action.
• Analyze § 18’s exceptions, savings provisions, grandfathering rules, and waiver provisions.
• Distinguish temporary pause preemption from permanent preemption following final federal action.

IV. Bottom Line

The principal consequence of East Fork is that the condition of use becomes the operative federal regulatory unit, creating a closer linkage among § 6(b) risk evaluation, the condition-specific unreasonable-risk determination, § 6(a) risk management or § 6(i) no-unreasonable-risk action, and § 18 preemption.

The shift to a “use-by-use” approach is more than a procedural requirement that EPA produce additional findings because it can provide affirmative federal regulatory certainty for uses determined not to present unreasonable risk, while permitting EPA to regulate other uses of the same chemical that do present unreasonable risk. At the same time, it requires a careful, use-specific comparison before concluding that a state requirement is preempted and application of TSCA § 18 to a particular state requirement requires comparison of the exact state provision with the scope, procedural posture, and legal status of EPA’s relevant risk evaluation, § 6(i) determination, or § 6(a) rule, including all statutory exceptions.

Authorities 

• East Fork Enters., Inc. v. EPA, Nos. 24-60227 & 24-60256 (5th Cir. Sept. 15, 2026)
• TSCA §§ 6(a), 6(b), 6(i), and 18; 15 U.S.C. §§ 2605 and 2617.