EPA Finalizes Changes to Improve Chemical Reviews

TUESDAY, FEBRUARY 13, 2024


In order to strengthen the Toxic Substances Control Act implementation, the U.S. Environmental Protection Agency recently finalized amendments to law that are intended to improve sustainability, efficiency, and health and safety precautions.

“Under the Biden-Harris Administration, we’ve made incredible progress implementing our nation’s chemical safety law, and today is another major step forward as we work to build a more sustainable, efficient program that protects public health,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. 

“This final rule will provide more resources, allowing EPA to review more chemicals more efficiently which means better and faster protections for communities from dangerous chemicals and robust support for American innovation of new chemistries.”

According to the agency’s press release, the amendments update how it will recover authorized costs of the 2018 TSCA Fees Rule implementation and ensure that collected fees provide the agency with 25% of authorized costs consistent with direction from Congress.

About the Updates

The agency says that the previous 2016 amendments to the TSCA greatly increased its authority and responsibility to protect people and the environment from toxic chemicals.

However, while Congress provided the EPA with new authority to collect fees to offset up to 25% of authorized TSCA implementation costs, the 2018 TSCA Fees Rule resulted in collection of less than half of the costs EPA had the authority to collect, adding to implementation challenges caused by insufficient resources.

Reports from the EPA’s Office of Inspector General and the U.S. Government Accountability Office found that the EPA was lacking resources for the TSCA program and the impact it has had on implementing the 2016 law, as well as the need for better cost estimates, the agency explains.

Additionally, the EPA’s October 2022 report to Congress on the agency’s capacity to implement the 2016 law acknowledges compounding failures on the EPA’s part in the first few years following enactment to adequately assess its resource needs early and to establish fees that capture the updated cost of EPA’s TSCA work.

The EPA says that it based its November 2022 proposed rule on its comprehensive 2021 analysis that more adequately accounted for the anticipated costs of implementing the amended law based on data from the first several years of implementation.

In last week’s final rule, the EPA plans to reduce the total program cost estimate by over 19% to approximately $146.8 million (compared to approximately $181.9 million in the 2022 proposed rule) as a result of its comprehensive budget analysis.

The EPA has also reportedly identified numerous efficiencies through its experience implementing TSCA that have brought down the estimated costs. Some of these efficiencies include more targeted data reviews and analyses refinement.

The agency notes it will likely need to spend less money gathering data on the next set of chemicals being prioritized for risk evaluation.

Specifically, the fees associated with EPA-initiated risk evaluations have been reduced from $5.1 million to $4.3 million, and the fees for review of a new chemical submissions have been reduced from $45,000 to $37,000.

The final rule will be effective 60 days after publication in the Federal Register. The final rule can be read here.

Risk Evaluation Prioritized Chemicals

At the end of last year, the EPA reportedly started the process to prioritize five additional toxic chemicals for risk evaluation under the TSCA. According to the agency’s release, during the 12-month long statutory process, if the EPA designates these five chemicals as High Priority Substances, it will then begin risk evaluations for these chemicals.

The EPA plans to prioritize the following chemicals for risk evaluation:

  • Acetaldehyde (CASRN 75-07-0): primarily used in the manufacturing and processing of adhesives, petrochemicals, and other chemicals, as well as intermediates for products like packaging and construction materials. Exposure to acetaldehyde may result in a range of health effects such as irritation of the respiratory system;
  • Acrylonitrile (CASRN 107-13-1): primarily used in the manufacturing and processing of adhesives, petrochemicals, and other chemicals, as well as intermediates for products like packaging and construction materials. Exposure to acetaldehyde may result in a range of health effects such as irritation of the respiratory system;
  • Benzenamine (CASRN 62-53-3): used in the manufacturing and processing of dyes and pigments, petrochemicals, plastics, resins and other chemicals. Exposure to benzenamine may result in a range of health effects such as adverse effects on the blood, fetal development and reproduction;
  • 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4): used in the manufacturing and processing of rubbers, plastics, resins and other chemicals. There is also extensive data that demonstrate exposure to MBOCA may damage genetic material in cells, potentially leading to other adverse health effects, particularly when exposure occurs to infants and children.; and
  • Vinyl Chloride (CASRN 75-01-4): primarily used in the manufacturing and processing of plastic materials like polyvinyl chloride (PVC), plastic resins and other chemicals, many of these materials are used for pipes, insulating materials and consumer goods. Exposure to vinyl chloride may result in a range of health effects such as liver toxicity.

With the exception of vinyl chloride, which a known human carcinogen, the chemicals are labeled by the agency as probable human carcinogens.

The EPA will review the hazard and exposure potential of each chemical, whether it builds up in the environment, whether there are potentially exposed or susceptible subpopulations, whether the chemical is stored near significant sources of drinking water, how the chemical is used, and the volume in which it is manufactured or processed.

   

Tagged categories: Construction chemicals; Environmental Protection; Environmental Protection Agency (EPA); EPA; Good Technical Practice; Government; hazardous materials; Hazards; Health and safety; NA; North America; Program/Project Management; Regulations

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