Key Takeaways

In December 2023, the U.S. Environmental Protection Agency (EPA) announced three significant actions under the Toxic Substances Control Act (TSCA):

1. It published a notice that it is initializing the prioritization process for five chemical substances under section 6(b)(1) of TSCA. This is the first stage in the regulatory process that may lead to EPA restricting or banning the use of these chemicals. Stakeholders have until March 18, 2024 to submit public comments. The five chemicals are:
   • Acetaldehyde
   • Acrylonitrile
   • Benzenamine
   • Vinyl Chloride
   • 4,4’-Methlynebis (2-chloronailine) (MBOCA)
2. EPA issued a data call-in for MBOCA under section 8(c) of TSCA. The Agency must receive records of significant adverse effects to human health or the environment related to MBOCA on or before February 26, 2024. In connection with this action, EPA has released new guidance on reporting information under section 8(c).
3. EPA announced that it expects to issue a proposed rule under TSCA section 8(d) to require manufacturers and importers of certain existing chemicals to send EPA copies of unpublished health and safety studies. The proposed rule is expected to be published in March 2024, followed by the final rule in September 2024.

Prioritization of Five Chemicals

EPA published a notice of initiation of prioritization under TSCA for acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and MBOCA, 88 Fed. Reg. 87423 (Dec. 18, 2023). EPA requested information from stakeholder relevant to the potential risks of these chemicals.

Section 6(b) of TSCA requires EPA to designate selected chemical substances as high-priority substances, at which point EPA will initiate a risk evaluation to determine whether the chemical “presents an unreasonable risk of injury to health or the environment.” If EPA determines that the chemical substance presents an unreasonable risk, it must promulgate regulations under section 6(a) to prohibit or otherwise restrict the substance.

EPA also considered ten other chemical substances for prioritization but has not yet begun the  prioritization process. EPA is requesting information on the hazards of these chemical substances. They are:

• 4-tert-Octylphenol(4-(1,1,3,3-tetramethylbutyl)-phenol)
• Benzene
• Bisphenol A
• Ethylbenzene
• Naphthalene
• Styrene
• Tribromomethane
• Triglycidyl isocyanurate
• Hydrogen fluoride
• N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD)

EPA will likely designate most of these substances as high-priority chemical substances within the next few years. However, input from stakeholders at this time can inform EPA’s decision-making when deciding if and how to conduct risk evaluations for these chemicals. Stakeholders should consider submitting comments to EPA during the prioritization process to provide valuable information that may help shape future regulations. The public comment period ends on March 18, 2024.

Section 8(c) Data Call-In for MBOCA

In connection to the Agency’s initiation of the prioritization process for MBOCA, a curing agent for liquid polyurethane elastomers, EPA has issued a data call-in for MBOCA under TSCA’s section 8(c), the first in decades. The notice indicates that EPA regards this call-in as “a first pilot step in making use of the TSCA section 8(c) data gathering authority as part of the general candidate selection process to be used by EPA for TSCA section 6 prioritization activities.”

Under section 8(c), chemical companies are required to maintain records of “significant adverse reactions” to human health or the environment alleged to have been caused by chemicals that they manufacture or process. This recordkeeping requirement includes records of employee health-related effects reported to the company over the last 30 years, as well as reports of other harms over the past five years. EPA has authority under section 8(c) to request submission of these records. EPA’s section 8(c) regulations appear in 40 C.F.R. Part 717.

EPA’s stated purpose for this data call-in is to “support the prioritization process to better understand suspected adverse health or environmental effects of [MBOCA],” and to “help make the risk evaluation process more efficient and focused.” The section 8(c) call-in requires any company that manufactures, imports, or processes MBOCA to submit any records of significant adverse reactions from MBOCA to EPA that fall under section 8(c)’s requirements. EPA must receive records on or before February 26, 2024.

EPA has stated that it is planning to use the section 8(c) call-in process “as part of the general candidate selection process . . . for TSCA section 6 prioritization activities.” EPA is considering using section 8(c) to collect data on one or more of the other five chemicals undergoing prioritization in the coming months.

EPA’s Guidance on Section 8(c) Recordkeeping and Reporting

At the same time the Agency issued the section 8(c) notice, EPA also posted guidance to assist chemical companies with compliance with the section 8(c) requirements. This guidance is the first released by EPA since its previous 1985 guidance.

The new section 8(c) guidance includes:

• Clarification that significant adverse reactions may include lesser aggregate effects to a group of individuals, or effects that repeatedly occur to a specific individual.
• Elaboration on the exemption for “known human effects,” which includes publicly available sources such as product labels and scientific literature.
  • The exemption does not apply if the “significant adverse reaction” was a significantly more severe toxic effect than previously described, or the exposure levels or route are different than previously described.
• Clarification that recordkeeping requirements are not triggered if the cause of a significant adverse reaction to the environment can be directly attributed to an accidental environmental contamination that has been reported to the federal government under any applicable authority.
  • Releases reported to state authorities are not exempt unless the state authority has been delegated oversight under federal law or implementing regulations.

New Section 8(d) Rule Scheduled

EPA announced in the most current Regulatory Agenda that it is developing a proposed rule under section 8(d) of TSCA to require manufacturers, importers, and processors of certain chemical substances to submit to EPA lists and copies of unpublished health and safety studies regarding those chemicals. The notice does not identify the substances to be listed, but they are likely to include the 15 substances identified as potential candidates for prioritization.
EPA expects to promulgate a notice of proposed rulemaking in March 2024. At this point stakeholders will be able to provide feedback to EPA prior to the promulgation of the final rule, which is expected in September 2024.

Beveridge & Diamond’s Chemicals Regulation practice group and Chemicals industry group provide strategic, business-focused advice to the global chemicals industry. We work with large and small chemical and products companies whose products and activities are subject to EPA’s broad chemical regulatory authority under TSCA and state chemical restrictions.