EPA Takes Another Step in Regulating Chemical Manufacturers and Article Importers

At a Glance

• This proposed rule continues EPA’s movement to require companies that import products that contain regulated chemicals — not just the chemical itself — to comply with TSCA.
• Companies that manufacture or import articles that contain 16 chemicals, such as benzene and styrene, will need to comply with this rule.
• This rule does not have any de minimus or impurity thresholds.
• Companies that fall under this rule are required to submit unpublished health and safety studies to the EPA within 90 days of publication of the final rule.
• Comments are due on EPA’s proposed rule by May 28, 2024.

On March 26, 2024, the U.S. Environmental Protection Agency (EPA) proposed a rule under Section 8(d) of the Toxic Substances and Control Act (TSCA) to require all manufacturers and importers to report unpublished health and safety studies to EPA for an additional 16 chemicals listed below. While this may not seem like a significant regulatory action — EPA estimates that only 161 entities will be impacted at a cost of about $300,000 for the industry to comply – EPA is once again proposing to require two significant features that were in EPA’s TSCA Section 8(a)(7) PFAS regulation:  

• the inclusion of imported articles that contain any of the chemicals (article importers). 
• the removal of the TSCA exemption for the chemical being an impurity and requiring reporting of any level of the chemicals at issue.

Who is Regulated by This Rule?

Any company that currently (or in the previous 10 years) manufacturers or imports — including as part of an article — any of the 16 chemicals provided below. 

According to EPA, they believe that 161 companies will be regulated by this rule, of which 51 will need to submit reports to EPA. However, EPA’s analysis does not appear to consider the addition of “article importers” in this calculus, likely understating its impact. 

The 16 chemicals are used in products such as plastics, resins, latex, refrigerants and electrical components — many of which are imported into the United States as part of articles. Additionally, there are no impurity or de minimis exemptions. Therefore, thousands of companies could potentially be covered under this rule — although many companies will only need to report if they have unpublished health and safety studies (similar to the TSCA 8(a)(7) PFAS rule). 

What do Companies Have to do to Comply?

Companies covered by this rule are required to provide unpublished health and safety studies to EPA. EPA interprets “health and safety studies” broadly and is not only information from formal, disciplined studies, but any data that bear the effects of the chemical on health or the environment. 40 C.F.R. § 716.3. These include completed studies that are available when the rule goes into effect as well as initiated, but not concluded, studies. The types of unpublished studies include:

• Toxicity studies on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetic, including modeling.
• Environmental effects and physical-chemical properties performed consistent with 40 C.F.R. §716.50.
• Occupational, general population, consumer and environmental exposure.
• Surveys, tests and studies of biological, photochemical and chemical degradation.

Studies that have been previously submitted to EPA do not need to be resubmitted and studies conducted pursuant to TSCA Section 4 are exempt.

What is the Standard of Review for Companies’ Records?

EPA has limited the records search to those locations where the required information is typically kept and to records kept by employees who are responsible for keeping such records or advising the company on health and environmental effects of chemicals. 40 C.F.R. § 716.25.

What Chemicals are Regulated Under This Proposed Rule?

EPA is placing these obligations on companies that manufacture (including import) any of the following 16 chemicals:

• 4,4-Methylene bis(2-chloraniline) (CASRN 101–14–4)
• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN140–66–9)
• Acetaldehyde (CASRN75–07–0)
• 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)
• Tribomomethane (Bromoform) (CASRN 75–25–2)
• Triglycidyl isocyanurate; (CASRN 2451–62–9)
• Hydrogen fluoride (CASRN 7664–39–3)
• N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (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).

How Long do Companies Have to Comply?

Companies will have 90 days from date of the final rule to submit any unpublished health and safety studies. Companies can request “reasonable” extensions if they file those requests with EPA within 40 days of the final rule. 40 C.F.R. § 716.60(c). For example, EPA extended the compliance timeframe for an additional 62 days and 117 days for various chemicals in the 2021 TSCA 8(d) rule. EPA’s justification for the extension was based on companies’ ability to familiarize themselves with the rule and potential challenges with obtaining records due to COVID-19. 

When Does the Public Comment Period Close?

Comments must be submitted to the EPA by May 28, 2024.