reasoned cost-benefit risk analysis , as required under TSCA . If this dubious logic prevails , the EPA may be in the awkward position of needing to ban every chemical that it determines as presenting an unreasonable risk when PPE is not used .
Taken to its logical extreme , this means that the agency will be compelled to ban all or nearly every substance it reviews under TSCA Section 6 , at least for the foreseeable future , because it is entirely likely that the substances it reviews over the next several decades will be sufficiently hazardous for it to conclude that the chemical substances present an unreasonable risk from routine , unprotected inhalation and / or dermal exposures . This logical inference alone should raise alarm bells for chemical stakeholders .
Finally , the final rule raises novel legal and science policy issues that are equally likely to arise in other risk management rules the EPA is issuing , including the recently promulgated final risk management rule on methylene chloride issued on 8 May .
The EPA ’ s use in the asbestos rule of a rescinded 2018 Application of Systematic Review in TSCA Risk Evaluations ( SR Document ) invites significant controversy and reflects a serious departure from the agency ’ s commitment to use the best available science as required under TSCA Section 26 ( h ). The crux of this issue is that the US National Academies of Sciences , Engineering , and Medicine reviewed the SR Document and concluded that the EPA ’ s approach to systematic review does “ not adequately meet the state-of-practice ”. 3
A related issue is the EPA ’ s derivation of an inhalation unit risk ( IUR ) for chrysotile asbestos and the use of the IUR for establishing the all-important
The use of PPE further complicates the recent ruling
ECEL . The EPA derived the IUR on textile worker populations from two facilities , a population many thought to be inadequate and responsible for eliciting an indefensibly strict level because these workers were also exposed to amphibole fibres , a more potent type of asbestos .
The third legal issue relates to the EPA ’ s unreasonable risk determination . The agency referenced its 1994 Guidelines for Statistical Analysis of Occupational Exposure Data ( Guidelines ) as the justification for evaluating monitoring samples that were below the limit of detection ( LOD ). It stated that the Guidelines “ call for replacing non-detects with the LOD or LOQ [ limit of quantification ] divided by two or divided by the square root of two , depending on the skewness of the data distributions ”. 4
The approach in the Guidelines conflicts with the EPA ’ s 2008 Framework for Investigating Asbestos- Contaminated Superfund Sites ( 2008 Framework ), which states “[ w ] hen computing the mean of a set of asbestos measurements , samples that are ‘ non-detect ’ should be evaluated using a value of zero , not half the analytical sensitivity ”. The agency did not state its rationale for not using the 2008 Framework recommendations ( i . e . replacing non-detects with zero ).
The scientific methods and documents supporting this rule have
References : 1 : See Corrosion Proof Fittings v . EPA , 947 F . 2d 1201 ( 5th Circuit 1991 ) 2 : 89 Fed . Reg . 21970 ( 28 March 2024 ) 3 : Application of Systematic Review in TSCA Risk Evaluations , EPA Document EPA-740-P1-8001 , Office of Chemical Safety & Pollution Prevention ( OCSPP ) ( May 2018 ), available at https :// www . epa . gov / sites / default / files / 201806 / documents / final _ application _ of _ sr _ in _ tsca _ 05-31-18 . pdf 4 : EPA ( 2020 ) Risk Evaluation for Asbestos , Part I : Chrysotile Asbestos , EPA Document EPA-740-R1-8012 5 : Two small businesses filed a joint petition in the 5th Circuit Court of Appeals . See East Fork Enterprises , Inc . & EPIC Paint Company v . EPA , filed 10 May 2024
been publicly challenged by other expert academics in the field . As it is the first final rule under TSCA Section 6 , stakeholders should expect no less . This rule is not just about asbestos ; it reflects how the EPA will manage unreasonable risks for existing chemical substances it identifies as high-priority substances under Section 6 .
Outlook
As explained above , there are plenty of reasons to be alarmed . Details matter and every risk management rule will be different in terms of the data on which the EPA relies to identify unreasonable risk , how it develops a workplace chemical protection programme and how it establishes an ECEL . The court will decide whether it met its legal burden in the chrysotile asbestos rule .
As noted , the agency recently issued a final risk management rule on methylene chloride that reflects many of the same legal and science policy deficiencies . It has already been challenged . 5 Stakeholders are urged to review carefully all proposed risk management rules , engage actively in the rulemaking process and assert the arguments that align best with their advocacy to ensure the administrative record is complete to optimise the best judicial outcome on appeal . ●
Lynn L . Bergeson
MANAGING PARTNER
LAWBC k + 1 202 557 3801 J lbergeson @ lawbc . com j www . awbc . com
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981