On December 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final Health and Safety Reporting Rule under the Toxic Substances Control Act (TSCA) to require manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 100756. The rule applies to manufacturers in the North American Industrial Classification System (NAICS) codes for chemical manufacturing (NAICS code 325) and petroleum refineries (NAICS code 324110) that are currently manufacturing (including importing) a listed chemical substance (or will do so during the chemical’s reporting period), or that have manufactured (including imported) or proposed to manufacture (including import) a listed chemical substance within the last ten years. EPA notes that the rule may also affect manufacturers of substances for commercial purposes that coincidentally produce the substance during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. According to EPA, “such byproducts and impurities may, or may not, in themselves have commercial value,” but “[t]hey are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.” EPA will use the health and safety studies to inform its actions in carrying out its responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. The rule will be effective January 13, 2025. The final rule states that “[g]enerally, the reporting . . . is required by March 13, 2025.”

Chemical Substances Addressed in the Final Rule

The chemical substances addressed in the final rule are:

• 4,4-Methylene bis(2-chloraniline) (Chemical Abstracts Service Registry Number^® (CAS RN^®) 101-14-4);
• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CAS RN 140-66-9);
• Acetaldehyde (CAS RN 75-07-0);
• Acrylonitrile (CAS RN 107-13-1);
• Benzenamine (CAS RN 62-53-3);
• Benzene (CAS RN 71-43-2);
• Bisphenol A (BPA) (CAS RN 80-05-7);
• Ethylbenzene (CAS RN 100-41-4);
• Naphthalene (CAS RN 91-20-3);
• Vinyl chloride (CAS RN 75-01-4);
• Styrene (CAS RN 100-42-5);
• Tribromomethane (bromoform) (CAS RN 75-25-2);
• Triglycidyl isocyanurate; (CAS RN 2451-62-9);
• Hydrogen fluoride (CAS RN 7664-39-3);
• N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (CAS RN 793-24-8); and
• 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CAS RN 2754428-18-5).

In its December 12, 2024, press release, EPA states that the chemicals included in the final rule are of particular interest 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 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 notes that it identified 11 of the chemicals included in the final rule as candidates for the next round of prioritization, which will begin in December 2024:

Eight of these 11 chemicals are on the 2014 TSCA Work Plan.

EPA included 6PPD in response to its November 2023 grant of a TSCA Section 21 petition asking it to address the use of 6PPD in tires. In granting the petition, EPA agreed to take a number of actions, including issuing a TSCA Section 8(d) rule to gather additional data on 6PPD. EPA included 6PPD-quinone in this final rule because it is formed when 6PPD reacts with ozone air pollution and EPA-funded research has found that concentrations of 6PPD-quinone in stormwater are lethal for coho salmon. EPA states that hydrogen fluoride, while not on the TSCA Work Plan, “has previously been identified by EPA as a chemical substance under consideration for prioritization.”

Reporting Requirements

The specific types of health and safety studies include:

• Manufacturers who, in the ten years preceding the date a chemical substance is listed, either have proposed to manufacture or have manufactured any of the listed chemical substances must submit to EPA, during the 60-day reporting period specified in 40 C.F.R. Section 716.65 and according to the reporting schedule set forth at 40 C.F.R. Section 716.60, a copy of each specified type of health and safety study that is in their possession at the time the chemical substance is listed in Part 716.

   

• Manufacturers who, either at the time of or after the chemical substance is listed in 40 C.F.R. Part 716, propose to manufacture or are manufacturing the listed chemical substance must submit to EPA during the 60-day reporting period specified in 40 C.F.R. Section 716.65 and according to the reporting schedule set forth at 40 C.F.R. Section 716.60:

   

  • A copy of each specified type of health and safety study which is in their possession at the time the chemical substance is listed;

     

  • A list of the specified types of health and safety studies known to them but not in their possession at the time the chemical substance is listed;

     

  • A list of the specified types of health and safety studies that are ongoing at the time the chemical substance is listed and are being conducted by or for them;

     

  • A list of the specified types of health and safety studies that are initiated after the date the chemical substance is listed and will be conducted by or for them; and

     

  • A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated and is now complete regardless of completion date.

EPA states that it is requiring submission of information only on those studies in which the listed chemical is specifically identified in the studies.

Any person who manufactures (including imports) or who proposes to manufacture the listed chemical substance from January 13, 2025, to March 13, 2025, must:

• Inform EPA (by submitting a list) of any studies initiated during the period from January 13, 2025, to March 13, 2025, within 30 days of their initiation, but in no case later than April 14, 2025; and
• For those who submitted lists of studies that were ongoing or initiated during the period from January 13, 2025, to March 13, 2025, such persons must submit a copy of each study within 30 days after its completion, regardless of the study’s completion date.

Exemptions under the Rule

EPA states that it did not include the exemption listed at 40 C.F.R. Section 716.20(a)(9) that allows for the inclusion of an exemption for persons manufacturing a substance only as an impurity. Under the final rule, a person manufacturing or proposing to manufacture a listed substance must report on the substance where it was only manufactured (or is being proposed for manufacturing) as an impurity. The final rule requires reporting on any chemical grade/purity level of the chemical.

EPA notes that it is requiring submissions of health and safety studies from companies manufacturing the listed chemical substances, including when a company is importing the chemical substance as a pure substance, or within a mixture, formulated product, or article that contains the listed chemical substance. EPA notes that this includes instances where the chemical substance is manufactured only as an impurity. EPA states that it considers conditions of use (COU) associated with circumstances where a chemical substance subject to a risk evaluation even where the chemical substance is an impurity. To such ends, health and safety information associated with the COUs, whether as a pure chemical, part of a mixture or article, or as an impurity helps inform such risk evaluation.

Types of Studies That Must Be Submitted

Pursuant to 40 C.F.R. Sections 716.10 and 716.50, manufacturers are required to submit:

• Lists and copies of unpublished health and safety studies for all substances specified in this rule on health effects, such as toxicity studies on carcinogenicity, reproductive, and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetic (absorption, distribution, metabolism, or elimination), including modeling studies, in humans or animals.
• All unpublished studies on environmental effects and physical-chemical properties if performed as described in 40 C.F.R. Section 716.50.
• All unpublished studies on occupational, general population, consumer, bystander, and environmental exposure, such as: unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modeling studies that estimate environmental concentrations or human exposures.
• Studies showing any measurable content of the listed substance (single substance or mixture). The composition and purity of test substances must be reported if included as part of the study.
• Surveys, tests, and studies of biological, photochemical, and chemical degradation. Chemical identities are part of the submitted health and safety studies or data and must be submitted to EPA. Information from health and safety studies and/or data relating to chemical substances offered for commercial distribution or subject to reporting under TSCA Section 4 or 5 is not protected from disclosure, with limited exceptions as stated in 15 U.S.C. Section 2613(2)(B).

EPA states that the following types of information are not included in this action and need not be submitted:

• Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter’s own accord and studies conducted or to be conducted pursuant to a TSCA Section 4 action are exempt from the submission of lists of health and safety studies required under 40 C.F.R. Section 716.35 and the submission of studies required under this rule.
• Certain types of studies when the subject of the study is a mixture known to contain a listed substance. These studies include acute oral toxicity; acute dermal toxicity; acute inhalation toxicity; primary eye irritation; primary dermal irritation; dermal sensitization; and physical-chemical properties.
• Analyzed aggregations of monitoring data when either based on monitoring data acquired over five years prior to the date of this rule, or when the data are not analyzed to determine the exposure or concentration levels of the listed chemical.

Commentary

EPA is smart to issue TSCA Section 8(d) data call-ins for the substances that are or may be undergoing prioritization and risk evaluation. EPA needs data on these substances to do its job. While we are clear on this, we are less clear that EPA is aware of the burden of the rule’s breadth.

EPA voided the exemptions for companies that manufacture or import the specified substances as impurities or in articles. EPA offers no de minimis threshold. This means that in addition to the companies that actually manufacture these substances, the entities likely to have the data EPA seeks, companies that import other substances that may have these substances present as impurities, and companies that import articles are also on the hook for potential reporting. As with the per- and polyfluroalkyl substances (PFAS) reporting rule that similarly contains no exemptions, EPA underestimates the burden of reporting and how this dilutes the utility and value of potentially responsive studies. The sheer volume alone of the information subject to reporting will make it difficult for EPA to find what it needs efficiently. The only saving grace is that EPA leaves in place the limitation in 40 C.F.R. Section 716.5(a) that only companies within NAICS codes 325 (chemical manufacturing and allied products) and 32411 (petroleum refineries) are required to respond.

In its economic analysis, EPA calculates the number of respondents by reviewing Chemical Data Reporting (CDR) reports for the substances. This estimate would only apply, however, if the potentially responsive studies were performed on the specified substances or mixtures that were known to include the substance. As written, every study that has been performed by any company in the specified NAICS codes is potentially responsive because any test substance might have contained one of the specified substances. EPA states that, “For this rulemaking, EPA is requiring submission of information only on those studies in which the listed chemical is specifically identified in the studies.” Unfortunately, this only provides relief of not reporting a study, it does not limit the scope of the rule and the requirement to review each study to see if one of the substances is identified.

In response to serious concerns raised by commenters on EPA’s lack of justification for the value of a toxicity study that contains a low level of a substance as an impurity, EPA states, “The presence of some chemicals, even at low concentrations, can significantly influence the associated overall health and environmental impacts.” (Response to Comments (RTC) at 15). This is not a scientific justification. EPA does not explain how it would disentangle the effect of the test substance from the effect of the impurity. We question whether “Collecting existing studies that reflect lower concentrations of these chemicals in mixtures ensures that EPA has a fuller understanding of the potential hazards of a chemical in different exposure scenarios.” EPA goes on to state, “For studies including chemicals at low concentrations, EPA will appropriately consider the quality of the study and the study’s design in interpreting the data, as part of the section 6 process.” EPA also states that “EPA uses established scientific methods to determine whether the effects observed can be reasonably linked to the listed substance. This involves assessing dose-response relationships and potential interactions with other substances. By adhering to these standards and guidelines, EPA aims to ensure that risk assessments are comprehensive and scientifically sound, incorporating data from all relevant studies to protect public health and the environment.” EPA is saying that it will review studies carefully and weigh the value of that information, which is entirely appropriate. This does not lessen the reporting burden for the companies that are required to scour hundreds of studies. EPA does not explain how it can or will be able scientifically to assess the value of a study with a substance as an impurity. We hope EPA has already reviewed the hundreds of thousands of studies to which it likely already has access to determine if these studies include any of the specified substances.

EPA offers some minor relief to reporters. If studies are submitted without any confidential business information (CBI) claims, the submitter need not include a study summary in the Organisation for Economic Co-operation and Development (OECD) harmonized template. Of course, any study submitted without CBI claims will be published in toto by EPA, potentially extinguishing entirely the intellectual property value of the study.

It is not clear how industry will respond. The reporting deadline is March 13, 2025. This leaves little time for the incoming Administration to do the rulemaking to change the rule. It also leaves little time for Congress to act under the Congressional Review Act. If an industry group files a challenge to the rule, EPA could request a voluntary remand, but other stakeholders may object.