EPA Has Not Yet Acknowledged the Implicit Impact of the Fifth Circuit Decision in East Fork Enterprises

The White House Office of Management and Budget is conducting a pre-publication review of a final rule that would amend the Procedures for Chemical Substance Risk Evaluations [1] performed by the U.S. Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA). The rule is expected to address, at least in part, shortcomings in EPA’s Section 6 risk management rulemaking process identified by the Fifth Circuit in East Fork Enterprises and the Ninth Circuit in Safer Chemicals.

However, especially given the short period of time since the Fifth Circuit issued its decision, it seems likely that EPA has not yet addressed, and may not yet have recognized, all of the shortcomings in its risk evaluation procedures explicitly or implicitly identified by East Fork Enterprises. Furthermore, even if EPA had been able to identify all of the shortcomings and a process for remedying them, there has been no opportunity for the mandatory notice and comment on some of the changes required by that decision. In reality, it appears unlikely that EPA is capable of remedying all of those shortcomings given the current limits of scientific knowledge. Simply stated, aside from routinely recurring workplace exposures over an extended time period, or isolated workplace exposures, EPA cannot reliably predict the adverse effects on human health expected to result from the potentially infinite variations in the duration, intensity, frequency, and number of exposures presented by the conditions of use. Without that knowledge, EPA cannot discern between reasonable and unreasonable risk. The basis for that conclusion is summarized in the following discussion. 

Section 6 of TSCA authorizes EPA to adopt risk management rules that prohibit or otherwise restrict the manufacture, processing, distribution in commerce, use, or disposal of chemicals that it determines pose an “unreasonable risk” to human health under their actual “conditions of use.” In evaluating the “conditions of use,” EPA must take into account “the likely duration, intensity, frequency, and number of exposures” in a manner “consistent with the best available science.” 

The fundamental holding of the Fifth Circuit in East Fork Enterprises is:

'Unreasonable risk' does not incorporate any precautionary principle [2]. Congress has spoken clearly when it instructed administrative agencies to adhere to the precautionary principle. … The TSCA’s text does not authorize anything like a precautionary or lowest possible risk principle [emphasis added].

The foundation of the Risk Management Rule for Methylene Chloride and all of the other risk assessments and risk management rules under Section 6 of TSCA is the precautionary principle. And the most critical application of the precautionary principle in EPA’s Section 6 risk management rulemakings is its decision to, in effect, rewrite Section 6 of TSCA as if it contained the precautionary language in Section 6(b)(5) of the Occupational Safety and Health Act (OSH Act), which states:

The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life [emphasis added].

That is how EPA justifies the adoption of enforceable daily existing chemical exposure limits (ECELs), which are based on the assumption that every worker would be exposed to the chemical for a 40- or 45-year working lifetime. If, however, Congress had intended for EPA to take that precautionary approach, Supreme Court decisions in Benzene and Cotton Dust demonstrate that Congress had tried-and-true statutory text for authorizing that approach in Section 6(b)(5) of the OSH Act. Nothing comparable to the quoted language from Section 6(b)(5) of the OSH Act appears anywhere in TSCA. That strongly implies Congress did not intend for Section 6 of TSCA to be interpreted in that manner.

Clear evidence of Congress’ intent not to incorporate Section 6(b)(5) of the OSH Act into Section 6 of TSCA is provided by the following provisions of TSCA:

In conducting a risk evaluation under this subsection, the Administrator shall—
(i) integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health … and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator; [and]
….
(iv) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance….

By incorporating Section 6(b)(5) of the OSH Act into Section 6 of TSCA, EPA ignores or renders meaningless the underlined portion of TSCA Section 6(b)(4)(F)(i) and all of Section 6(b)(4)(F)(iv), and would instead follow an interpretation that directly conflicts with those provisions.   

Finally, a practical example evidences Congress’ intent not to incorporate Section 6(b)(5) of the OSH Act into Section 6 of TSCA. Under the vacated Risk Management Rule for Methylene Chloride, if a worker’s exposure to methylene chloride was nominally above the enforceable daily ECEL for only one shift on only one day during the worker’s entire life, the employer would be in violation of TSCA, but the employee clearly would not have been exposed to an unreasonable risk. 

One might reasonably ask why EPA, in effect, rewrote Section 6 of TSCA to incorporate the precautionary approach from the OSH Act when Congress effectively declined to incorporate it into TSCA. There appear to be three possible explanations. 

First, it appears unlikely that EPA has the scientific data necessary to support the adoption of a comprehensive rule that regulates, only to the extent necessary to identify and eliminate unreasonable risk, the potentially infinite variations in the duration, intensity, frequency, and number of exposures presented by the conditions of use. EPA may have the scientific data needed to adopt a table of ECELs for workers who are likely to be exposed to a chemical from 1 to 12 hours per day, 4 or 5 days per week. EPA could also expand the analysis it employed to develop the 15-minute STEL to establish a table of exposure limits for workers who are likely to be infrequently exposed to a chemical from 15 minutes to 12 hours. That would leave a coverage gap for workers whose likely exposures do not fit either pattern.   

Second, any broader rule designed and limited to regulating only to the extent necessary to identify and eliminate unreasonable risk in the gap referenced above would likely require a burdensome and potentially impractical system for tracking, recording, and analyzing each worker’s aggregate exposures and cumulative risk on a continuing basis over his/her working lifetime. Finally, it is likely that any such broader rule would be challenging to enforce. While courts operate under a canon of interpretation that presumes statutory schemes should not be interpreted in a way that significantly limits their effectiveness, neither courts nor regulatory agencies may supply substantive language that Congress omitted, that conflicts with the language Congress included, or that renders the language Congress included as surplusage. 

The message of East Fork Enterprises is that EPA must go back to the drawing board, re-evaluate the data it has assembled on methylene chloride, re-interpret the meaning and significance of that data, and re-evaluate the justification and scope of an appropriate risk management rule.

[1] 40 CFR Part 702, Subpart B.

[2] Two widely-recognized statements of the precautionary principle read as follows:

Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

Principle 15 of the 1992 Rio Declaration of the United Nations Conference on Environment and Development. https://sdgs.un.org/sites/default/files/documents/1709riodeclarationeng.pdf

When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically.

Wingspread Statement on the Precautionary Principle, January 1998. https://www.gdrc.org/u-gov/precaution-3.html