U.S. EPA Final Rule under TSCA - Health and Safety Data Reporting

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Personal health information
Vol. 1451 | 02 Feb 2025

EPA Finalizes Health and Safety Data Reporting Rule

The U.S. Environmental Protection Agency (EPA) has published a final Health and Safety Data Reporting Rule, requiring manufacturers and importers of specific chemical substances to submit unpublished health and safety studies. This rule applies to companies within the chemical manufacturing (NAICS code 325) and petroleum refineries (NAICS code 324110). These chemicals are of particular interest to the EPA due to their potential health and environmental risks. The agency will use the submitted data to inform its prioritization, risk evaluation, and risk management of these chemicals under the Toxic Substances Control Act (TSCA).

Target Chemicals:

The rule targets 16 chemical substances, including

  1. Acetaldehyde, CASRN 75-07-0
  2. Acrylonitrile, CASRN 107-13-1
  3. 2-Anilino-5-[(4-methylpentan-2-yl) amino] cyclohexa-2,5-diene-1,4-dione (6PPD-quinone), CASRN 2754428-18-5
  4. Benzenamine, CASRN 62-53-3
  5. Benzene, CASRN 71-43-2
  6. Bisphenol A, CASRN 80-05-7
  7. Ethylbenzene, CASRN 100-41-4
  8. Hydrogen fluoride, CASRN 7664-39-3
  9. 4,4’-Methylene bis(2-chloraniline), CASRN 101-14-4
  10. N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD), CASRN 793-24-8
  11. Naphthalene, CASRN 91-20-3
  12. Styrene, CASRN 100-42-5
  13. 4-tert-octylphenol (4-(1,1,3,3- Tetramethylbutyl)-phenol), CASRN 140-66-9
  14. Tribromomethane (Bromoform), CASRN 75-25-2
  15. Triglycidyl Isocyanurate, CASRN 2451-62-9
  16. Vinyl Chloride, CASRN 75-01-4

Reporting Requirements:

Companies manufacturing or importing the listed chemical substances must submit health and safety studies, including instances where the substance is:

  • Imported as a pure substance or within a mixture, formulated product, or article.
  • Manufactured only as an impurity.

Electronic Submission:

Data must be submitted electronically using the TSCA Section 8(d) Health & Safety Data Reporting application within EPA's Central Data Exchange. This rule is effective on January 13, 2025 and reporting is required by March 13, 2025.

For questions, please contact Andrew Loveland (andrew.loveland@intertek.com) and Harini Ramaswamy (harini.ramaswamy@intertek.com).

 

If you have any questions, please contact:

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Harini Ramaswamy

Technical Manager, Softlines

Harini provides technical and regulatory support on consumer products testing to retailers in North America. She supports global labs, engages with regulatory bodies, industry groups and standards organizations. Harini holds a master’s degree in Design (Apparel Studies) from the University of Minnesota and B. Tech in Apparel Technology from Anna University, Chennai. Her functional apparel design projects presented at the Industrial Fabrics Association International (IFAI) and Techtextil conferences have won her numerous accolades. 

Email:  harini.ramaswamy@intertek.com

Image of Andrew Loveland
Andrew Loveland

Technical Director - Hardlines, Softlines and Toys

Andrew brings over 20 years of experience in the regulatory compliance and technical services industry relating to consumer products. With a background in electrical engineering, he advises on the technical aspects of identification and application of regulatory requirements and appropriate test methods necessary to measure safety, quality, and performance of consumer products. Andrew often advises retailers and suppliers on appropriate actions to effectively manage compliance risks.  

Email:  andrew.loveland@intertek.com  

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