EPA Announces Final Rule Requiring Manufacturers of Certain Chemicals to Submit Unpublished Health and Safety Studies
In late June 2021, a final rule was issued by the U.S. Environmental Protection Agency (EPA). This rule mandates the submission of unpublished studies of health and safety to the Agency by manufacturers of a group of 50 high-priority chemicals and organohalogen flame retardants. In this blog post, we review the rule and the chemical substances it covers.
50 Chemicals and the Final Rule
The chemicals covered by the EPA's final rule include 20 high priority substances (classified as such under the Toxic Substances Control Act (TSCA)) and 30 chemicals designated as organohalogen flame retardants (under the Federal Hazardous Substances Act).
| Substance Name | CAS Number | Classification |
|---|---|---|
| 1,1,2-Trichloroethane | 79-00-5 | High-Priority Substance |
| 1,1-Dichloroethane | 75-34-3 | High-Priority Substance |
| 1,1'-Ethane-1,2-diylbis(pentabromobenzene) | 84852-53-9 | Organohalogen Flame Retardant |
| 1,2-Bis(2,4,6-tribromophenoxy)ethane | 37853-59-1 | Organohalogen Flame Retardant |
| 1,2-Dichloroethane | 107-06-2 | High-Priority Substance |
| 1,2-Dichloropropane | 78-87-5 | High-Priority Substance |
| 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB) | 1222-05-5 | High-Priority Substance |
| 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene | 3278-89-5 | Organohalogen Flame Retardant |
| 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | 52434-90-9 | Organohalogen Flame Retardant |
| 1,3-Butadiene | 106-99-0 | High-Priority Substance |
| 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate | 20566-35-2 | Organohalogen Flame Retardant |
| 2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane] | 3072-84-2 | Organohalogen Flame Retardant |
| 2,4,6-Tribromoaniline | 147-82-0 | Organohalogen Flame Retardant |
| 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine | 25713-60-4 | Organohalogen Flame Retardant |
| 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate | 183658-27-7 | Organohalogen Flame Retardant |
| 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) | 79-94-7 | High-Priority Substance |
| Bis(2-ethylhexyl) tetrabromophthalate | 26040-51-7 | Organohalogen Flame Retardant |
| Bis(hexachlorocyclopentadieno)cyclooctane | 13560-89-9 | Organohalogen Flame Retardant |
| Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) | 85-68-7 | High-Priority Substance |
| Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester) | 84-74-2 | High-Priority Substance |
| Dicyclohexyl phthalate | 84-61-7 | High-Priority Substance |
| Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester) | 117-81-7 | High-Priority Substance |
| Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-methylpropyl) ester) | 84-69-5 | High-Priority Substance |
| Ethylene dibromide | 106-93-4 | High-Priority Substance |
| Formaldehyde | 50-00-0 | High-Priority Substance |
| Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine | 85535-85-9 | Organohalogen Flame Retardant |
| N,N-Ethylene-bis(tetrabromophthalimide) | 32588-76-4 | Organohalogen Flame Retardant |
| o-Dichlorobenzene | 95-50-1 | High-Priority Substance |
| p-Dichlorobenzene | 106-46-7 | High-Priority Substance |
| Pentabromochlorocyclohexane | 87-84-3 | Organohalogen Flame Retardant |
| (Pentabromophenyl)methyl acrylate | 59447-55-1 | Organohalogen Flame Retardant |
| Pentabromotoluene | 87-83-2 | Organohalogen Flame Retardant |
| Perbromo-1,4-diphenoxybenzene | 58965-66-5 | Organohalogen Flame Retardant |
| Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester | 6294-34-4 | Organohalogen Flame Retardant |
| Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester | 38051-10-4 | Organohalogen Flame Retardant |
| Phosphoric acid, triphenyl ester (TPP) | 115-86-6 | High-Priority Substance |
| Phthalic anhydride | 85-44-9 | High-Priority Substance |
| Propanoic acid, 2-bromo-, methyl ester | 5445-17-0 | Organohalogen Flame Retardant |
| Tetrabromobisphenol A bis(2-hydroxyethyl) ether | 4162-45-2 | Organohalogen Flame Retardant |
| Tetrabromobisphenol A diallyl ether | 25327-89-3 | Organohalogen Flame Retardant |
| Tetrabromobisphenol A dimethyl ether | 37853-61-5 | Organohalogen Flame Retardant |
| Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) | 21850-44-2 | Organohalogen Flame Retardant |
| trans-1,2-Dichloroethylene | 156-60-5 | High-Priority Substance |
| Tris(1,3-dichloro-2-propyl)phosphate | 13674-87-8 | Organohalogen Flame Retardant |
| Tris(1-chloro-2-propyl)phosphate | 13674-84-5 | Organohalogen Flame Retardant |
| Tris(2,3-dibromopropyl)phosphate | 126-72-7 | Organohalogen Flame Retardant |
| Tris(2-chloro-1-propyl)phosphate | 6145-73-9 | Organohalogen Flame Retardant |
| Tris(2-chloroethyl) phosphate (TCEP) | 115-96-8 | High-Priority Substance |
| Tris(2-chloroethyl)phosphite | 140-08-9 | Organohalogen Flame Retardant |
| Tris(tribromoneopentyl)phosphate | 19186-97-1 | Organohalogen Flame Retardant |
Source: Environmental Protection Agency
The EPA issued its final rule, which took effect in late July 2021, as these chemicals were added to the TSCA Priority Testing List. According to the rule, it requires “certain past, current, and prospective manufacturers (which under TSCA includes importers) to submit copies and/or lists of unpublished health and safety studies on the listed chemical substances that they manufacture. In some cases, EPA may also require processors to comply with the rule.”
More detailed information, including the specific types of studies that must be submitted, may be found by reviewing the rule itself.
Accessing the Information You Need
If you are a professional who requires detailed information on harmful chemicals, being able to access it quickly and easily is critical. To learn more about any of the chemicals addressed in the EPA’s final rule, as well as a host of others, ToxPlanet offers highly authoritative decision support solutions. To learn more about our offerings and how they can help address your information needs, contact us today and register for a Free Trial.
