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EPA Issues Final Rule on Significant New Use Regulations for Chemical Substances

TSCA
16
January 2025
•
NaN min read
Dr Steven Brennan
EPA finalises new rules for substances like soybean meal phosphoric trichloride and calcium propionate complexes under TSCA, effective March 2025. Learn more.
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The EPA has issued final rules on Significant New Use Regulations (SNURs) under the Toxic Substances Control Act (TSCA), targeting specific chemical substances, including soybean meal reaction products with phosphoric trichloride, calcium carbonate propionate complexes, and 2-propenoic acid polymers. These rules, effective from 7 March 2025, require manufacturers and processors to notify the EPA at least 90 days before commencing activities deemed as "significant new uses." The regulations aim to ensure environmental safety and minimise potential health risks associated with these substances. Businesses must adhere to strict recordkeeping and workplace safety requirements, particularly for chemicals like 2-propenoic acid polymers, which mandate high-protection respirators. This action underscores the EPA’s dedication to safeguarding public health and the environment by carefully regulating emerging uses of chemical substances.

What substances are affected by the EPA's new Significant New Use Rules (SNURs)?

The SNURs apply to various chemical substances, including soybean meal reaction products with phosphoric trichloride (PMN P–16–541), which are regulated for water release; calcium carbonate propionate complexes (PMN P–18–172), restricted to use in architectural coatings; and 2-propenoic acid polymers (PMN P–17–299), which require stringent workplace safety measures such as respirators with an Assigned Protection Factor (APF) of 1,000. These regulations ensure that significant new uses of these substances undergo EPA evaluation to mitigate risks to health and the environment.

How will the new SNURs impact chemical manufacturers and processors?

Chemical manufacturers and processors must comply with the new rules by submitting a Significant New Use Notice (SNUN) at least 90 days before engaging in regulated activities. This process allows the EPA to evaluate the potential risks of the proposed use and implement risk management measures if necessary. The cost of compliance includes SNUN fees, which are $14,500 for small businesses and $45,000 for larger entities. Non-compliance could result in penalties, making it essential for businesses to stay informed and ensure compliance.

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The Environmental Protection Agency (EPA) has finalised Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA), impacting manufacturers and processors of specific chemical substances. Effective 7 March 2025, these regulations mandate prior notification for activities deemed "significant new uses," ensuring compliance and reducing environmental risks.

What are SNURs and Why Are They Important?

SNURs designate specific activities involving chemical substances as "significant new uses," requiring a 90-day notification before these uses can begin. The EPA evaluates the associated risks under the conditions of use and implements risk management measures if necessary.

Affected Businesses and Responsibilities

Entities involved in chemical manufacturing, processing, or importing are required to comply with these SNURs. North American Industry Classification System (NAICS) codes, including chemical manufacturing (325) and petroleum refineries (324110), outline affected industries.

For small businesses, the cost of submitting a Significant New Use Notice (SNUN) is reduced to $14,500, compared to $45,000 for larger businesses. The EPA encourages early consultation to streamline the testing and notification process.

Key Chemical Substances Regulated

  • Soybean Meal, Reaction Products with Phosphoric Trichloride (PMN P–16–541): This chemical is now regulated for water release.
  • 2-Propenoic Acid Polymers (PMN P–17–299): Workplace safety measures, including respirators with an Assigned Protection Factor (APF) of 1,000, are mandatory.
  • Calcium Propionate Complexes (PMN P–18–172): Its use is restricted to architectural coatings.

Premanufacture Notice Codes

The PMN (Premanufacture Notice) codes are identifiers assigned to chemical substances that are subject to review under TSCA. Here are the PMN codes subject to the SNURs:

  • PMN P–16–541: Soybean meal, reaction products with phosphoric trichloride.
  • PMN P–17–299: 2-propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene glycol methacrylate alkyl ether (generic).
  • PMN P–18–172: Calcium carbonate 2-ethylhexanoate neodecanoate propionate complexes.
  • PMN P–19–99: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, and other components (used as a clear coat for wood).
  • PMN P–19–118: Substituted polyalkylenepoly, reaction products with alkene polymer (generic).
  • PMN P–19–120: Alkenoic acid, polymer with alkanediyl bis substituted alkylene bis heteromonocycle, substituted carbomonocycle, and (alkylalkenyl) carbomonocycle, alkali metal salt (generic).

These PMN codes identify specific chemicals now subject to the EPA's regulatory oversight under the updated SNURs, ensuring any new significant uses undergo a review process to mitigate environmental and health risks.

Costs and Implications for the Industry

The submission of a SNUN incurs costs but is essential to prevent environmental hazards. The EPA estimates a cost of $106 per export notification, with additional costs for testing and compliance.

Despite the financial burden, these regulations are designed to mitigate risks before the manufacture or processing of hazardous chemicals.

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