EPA Proposes Health and Safety Data Reporting Rule for 16 Chemicals Being Considered for Risk Evaluation under TSCA
Released on March 25, 2024
List includes vinyl chloride, the chemical involved in the East Palestine, OH train derailment
The U.S. Environmental Protection Agency (EPA) is proposing a rule under section 8(d) of the Toxic Substances Control Act (TSCA) that would require manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. In addition to health and safety studies, manufacturers would also be required to submit unpublished studies on environmental effects and occupational, general population and consumer exposure for these chemicals. These studies would help inform EPA’s prioritization, risk evaluation and risk management of chemicals under TSCA, furthering the Agency’s efforts to protect human health and the environment.
The proposed rule includes 13 chemicals that are on the 2014 TSCA Work Plan, a list of chemicals identified by EPA for further assessment based on their hazards and potential for exposure. For prioritization, risk evaluation and risk management, EPA needs information on the hazards of a chemical and how people might be exposed.
EPA proposed to prioritize five of the chemicals included in the proposed rule for risk evaluation in December 2023, all of which are linked to cancer and used to make plastic:
- 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4),
- Acetaldehyde (CASRN 75-07-0),
- Acrylonitrile (CASRN 107-13-1),
- Benzenamine (CASRN 62-53-3), and
- Vinyl Chloride (CASRN 75-01-4).
The proposed rule also includes 10 chemicals EPA identified as candidates for prioritization, did not ultimately include in its December 2023 initiation of prioritization action, but is considering including in its December 2024 initiation of prioritization action:
- 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9),
- Benzene (CASRN 71-43-2),
- Bisphenol A (CASRN 80-05-7),
- Ethylbenzene (CASRN 100-41-4),
- Hydrogen fluoride (CASRN 7664-39-3),
- N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8),
- Naphthalene (CASRN 91-20-3),
- Styrene (CASRN 100-42-5),
- Tribomomethane (Bromoform) (CASRN 75-25-2), and
- Triglycidyl isocyanurate (CASRN 2451-62-9).
Additionally, in November 2023, EPA granted a petition from the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians asking the Agency to address the use of the chemical 6PPD in tires. 6PPD reacts with ozone air pollution to form a chemical called 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN: 2754428-18-5). EPA-funded research has found that concentrations of 6PPD-quinone in stormwater are lethal for coho salmon. In granting the petition, EPA agreed to take a number of actions under TSCA, including finalizing a rule under TSCA section 8(d) to gather additional data on 6PPD. EPA is thus including 6PPD-quinone in this proposed rule.
Upon publication of the Federal Register notice, EPA will accept public comments on this proposed rule for 60 days at www.regulations.gov under docket EPA-HQ-OPPT- 2023-0360.