EPA Finalizes Health and Safety Data Reporting Rule for 16 Chemicals Being Considered for Risk Evaluation under TSCA 

Released December 12, 2024

Today, the U.S. Environmental Protection Agency (EPA) announced a final rule under section 8(d) of the Toxic Substances Control Act (TSCA) requiring manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. These health and safety studies will 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. In addition to health and safety studies, manufacturers are required to submit unpublished studies on environmental effects and occupational, general population, and consumer exposure for these chemicals.  

The chemicals subject to this rule are:  

• 4,4-Methylene bis(2-chloraniline) (MBOCA) (CASRN 101-14-4);  

• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9);  

• Acetaldehyde (CASRN 75-07-0);  

• Acrylonitrile (CASRN 107-13-1);  

• Benzenamine (CASRN 62-53-3);  

• Benzene (CASRN 71-43-2);  

• Bisphenol A (CASRN 80-05-7);  

• Ethylbenzene (CASRN 100-41-4);  

• Naphthalene (CASRN 91-20-3);  

• Vinyl Chloride (CASRN 75-01-4);  

• Styrene (CASRN 100-42-5);  

• Tribromomethane (Bromoform) (CASRN 75-25-2);  

• Triglycidyl isocyanurate; (CASRN 2451-62-9);  

• Hydrogen fluoride (CASRN 7664-39-3); and 

• N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8);                 

• 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5).  

EPA is requiring submission of health and safety studies from companies manufacturing the identified chemicals, including when a company is importing the chemical as a pure substance, or within a mixture, formulated product, or article that contains the subject chemical. This final rule will help EPA understand and address environmental and toxic exposures to ensure that every community has access to clean air and water. 

The chemicals included in today’s action are of particular interest to EPA because they are either in the process of prioritization as candidates for high-priority designation for risk evaluation or are expected to be candidates in upcoming years.  

In July 2024, EPA proposed to designate five of the chemicals included in the rule as High-Priority Substances for risk evaluation: MBOCA, Acetaldehyde, Acrylonitrile, Benzenamine and Vinyl Chloride, all of which are linked to cancer and used to make plastic.  

EPA identified 11 of the chemicals included in the final rule as candidates for the next round of prioritization, which will begin in December 2024: 

• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol), 

• Benzene, 

• Bisphenol A, 

• Ethylbenzene, 

• Hydrogen fluoride, 

• 6PPD, 

• 6PPD-quinone, 

• Naphthalene, 

• Styrene,  

• Tribomomethane (Bromoform), and 

• Triglycidyl isocyanurate. 

Eight of these 11 chemicals 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.   

Additionally, 6PPD is included in response to EPA’s November 2023 grant of 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 6PPD-quinone. 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 thus included 6PPD-quinone in the final rule. EPA is currently soliciting information on the potential risks associated with 6PPD and 6PPD-quinone via an advance notice of proposed rulemaking. The comment period for this solicitation ends on January 21, 2025.  

Hydrogen fluoride, while not on the TSCA Work Plan, has previously been identified by EPA as a chemical substance under consideration for prioritization. Stakeholders have expressed interest in EPA conducting risk evaluation on hydrogen fluoride. Accordingly, EPA considers the chemical substance as a potential candidate for prioritization and seeks to increase its information on the chemical pursuant to this rule. 

In looking ahead to the next round of candidate chemicals that will undergo prioritization, EPA held public webinars in September and October of 2024 and opened a public docket to gather information. EPA presented a list of 25 chemicals that are currently under consideration.   In December of 2024, EPA is also planning on identifying 5 additional chemicals to undergo the 9-12 month prioritization process. Similar to last year, the Agency looks to select chemicals that have sufficient information to conduct a risk evaluation of the full range of conditions of use.    

Read the final rule.