After many years of study, the U.S. Environmental Protection Agency (EPA), industry stakeholders, and the scientific community at large well know that chemicals that are persistent, bioaccumulative, and toxic (PBT) behave differently in the environment and in biological systems than non-PBT chemicals. Congress acknowledged this in updating the Toxic Substances Control Act (TSCA) in 2016 by specifying special provisions under TSCA Section 6(h) for PBT chemicals. In June of this year, the EPA proposed a rule implementing TSCA Section 6(h) review that elicits important insights on how the EPA intends to review such chemicals. The rule is a blueprint for its consideration of PBTs for years to come.
PBT chemicals are known to remain in the environment and biological settings for long periods of time and thus pose unique challenges for chemical producers, users and regulators. In light of these attributes, TSCA Section 6(h) requires the EPA to propose regulatory action by June 22, 2019, on chemicals from the 2014 update of the TSCA Work Plan that meet the PBT requirements under TSCA. The proposed rule must address the risks presented by the chemicals and reduce exposure “to the extent practicable.”
The EPA identified five PBT chemicals that meet the statutory criteria: decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)) — also known as tris (4-isopropylphenyl) phosphate; 2,4,6-tris (tert-butyl) phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). The EPA proposes restricting or prohibiting certain actions with respect to four of the five chemicals — DecaBDE; PIP (3:1); 2,4,6-TTBP; and PCTP. Affected entities would be required to maintain, for three years from the date the record is generated, business records that demonstrate compliance with the restrictions, prohibitions and other requirements.
Importantly, the proposed rule includes hazard summaries for each of the five PBT chemicals. The EPA “did not perform a systematic review of the literature to characterize the hazards of the five PBT chemicals, and instead performed a limited survey of the reasonably available scientific information.” The agency states that “[d]ue to Congress’ direction in TSCA to expeditiously regulate PBTs on the 2014 Work Plan and because risk evaluations were not required by Congress, EPA prepared a fit-for-purpose summary of the hazards presented by the five PBT chemicals.” The proposed rule summarizes reasonably available hazard information. The EPA notes hazard statements “are not based on a systematic review of the available literature and information may exist that could refine the hazard characterization.”
The proposed regulation is significant for any entity making or using these chemicals. The EPA largely will refrain from regulating commercial uses of the chemicals and instead rely on other laws such as the Resource Conservation and Recovery Act (RCRA) and the Occupational Safety and Health Act (OSH Act) concerning areas falling under their respective scope to address potential exposure issues. In deferring to other statutory authorities to address potential exposure situations that may pose a risk, the EPA is likely to elicit strong opposition from stakeholders who prefer a more restrictive regulatory approach. The EPA’s reliance upon other federal authorities is an important and recurrent theme in its TSCA implementation approach and, in our view, is a reasonable interpretation of the law. The EPA also has proposed specific exceptions for certain uses of these PBTs, and readers will want to support the EPA’s decisions in this regard.
Another aspect that will be interesting to watch play out is the EPA’s approach to and the forthcoming comments on the requirement in TSCA Section 6(h)(4) that EPA’s Section 6(a) regulation “reduce exposure to the substance to the extent practicable.” Interestingly, EPA uses an extent practicable argument in part when explaining its proposal not to regulate in areas otherwise covered by RCRA and the OSH Act. The EPA conducted letter peer reviews of exposure and hazard information for the five PBT chemicals, and also accepted written comments on the charge questions and other documents to be considered by the peer reviewers. These materials are available online in Docket ID EPA-HQ-OPPT-2018-0314.
Stakeholders making or using these PBT substances should review and participate as appropriate in this important rulemaking. How the EPA regulates PBT substances will significantly impact manufacturing and chemical processing operations for years to come and it’s important that EPA develop an enduring and legally defensible framework for doing so. The EPA welcomes comments on building its approach to PBT chemical review and regulation. Stakeholders making or using these chemicals, or other chemicals likely to be designated as PBT chemicals, are urged to engage in this initiative.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.