On June 29, 2021, the U.S. EPA published a final rule requiring manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. The EPA’s final rule was issued pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The EPA established detailed reporting requirements for chemical substances added by the final rule to the TSCA Health and Safety Data Reporting rule and designated 20 chemical substances subject to the final rule as “High-Priority Substances.” The EPA additionally identified 30 organohalogen flame retardants as being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The EPA will use the submitted information to develop risk evaluations and related prioritizations. The final rule will become effective on July 29, 2021 and requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021.
The high-priority substances and organohalogen flame retardants included in the final rule are:
High-Priority Substances
1,3-Butadiene; Butyl benzyl phthalate (BBP) (1,-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester); Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,-dibutyl ester); o-Dichlorobenzene; p- Dichlorobenzene; 1,1-Dichloroethane; 1,2-Dichloroethane; trans-1,2-Dichloroethylene; 1,2-Dichloropropane; Dicyclohexyl phthalate; Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboylic acid, 1,2-bis(2-ethylhexyl) ester); Di-isobutyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2bis(-methylpropyl) ester); Ethylene Dibromide; Formaldehyde; 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyra (HHCB); 4,4’-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); Phosphoric acid, triphenyl ester (TPP); Phthalic anhydride; 1,1,2-Trichloroethane; Tris(2-chlorethyl) phosphate (TCEP).
Organohalogen Flame Retardants
Bis(2-ethylhexyl) tetrabromophthalate; Bis(hexachlorocyclopentadieno)cyclooctane; 1,2-Bis(2,4,6-tribromophenoxy)ethane; 1,1′-Ethane-1,2-diylbis(pentabromobenzene); 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate; 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate; 2,2′-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane]; Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine; N,N-Ethylene-bis(tetrabromophthalimide); Pentabromochlorocyclohexane; (Pentabromophenyl)methyl acrylate; Pentabromotoluene; Perbromo-1,4-diphenoxybenzene; Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester; Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester; Propanoic acid, 2-bromo-, methyl ester; Tetrabromobisphenol A-bis(2,3-dibromopropyl ether); Tetrabromobisphenol A bis(2-hydroxyethyl) ether; Tetrabromobisphenol A diallyl ether; Tetrabromobisphenol A dimethyl ether; 2,4,6-Tribromoaniline; 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene; Tris(2-chloroethyl)phosphite; Tris(1-chloro-2-propyl)phosphate; Tris(2-chloro-1-propyl)phosphate; Tris(2,3-dibromopropyl)phosphate; 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; Tris(1,3-dichloro-2-propyl)phosphate; Tris(tribromoneopentyl)phosphate; 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine.
The EPA reported that it is seeking unpublished health and safety studies to ensure that high-quality information is available to the EPA to inform its risk evaluation findings of whether any of these “High-Priority Substances” present an unreasonable risk of injury to the environment and public health.
It has been over a decade since the EPA has updated its TSCA New Chemicals Categories report published in August 2010. The submission of the information sought by the June 29 final rule will influence the development of a new report and signals an aggressive use of the EPA’s TSCA information collection authority to ensure that the EPA is using the best available science as required under TSCA’s “Scientific Standards” Section 26(h).