Regulatory Update: Comprehensive Overview of the AIM Act for Medical Product Distributors and Healthcare Providers
Introduction
This report provides a detailed analysis of the U.S. Environmental Protection Agency’s (EPA) final rule under the American Innovation and Manufacturing (AIM) Act, focusing on the phasedown of hydrofluorocarbons (HFCs) and its implications for medical product distributors and healthcare providers. Effective January 1, 2025, this regulatory update mandates significant changes to ensure compliance with environmental protection goals.
The following sections outline the summary, key compliance issues, list of banned products, schedule of fines, and next steps, drawing from official EPA documentation and recent regulatory updates.
Summary of the AIM Act
The AIM Act, enacted on December 27, 2020, as part of the Consolidated Appropriations Act, 2021, authorizes the EPA to address HFCs, which are potent greenhouse gases used in applications such as aerosols, refrigeration, and air conditioning. The final rule, published on December 12, 2024, and effective January 1, 2025, focuses on restricting the use of certain HFCs in aerosol products, particularly in the medical sector. The primary objective is to phase down HFC production and consumption by 85% over the next few years. This rule aligns with the Clean Air Act and aims to facilitate the transition to climate-friendly alternatives, as detailed in the EPA’s Background on HFCs and the AIM Act.
Key Compliance Issues
Compliance with the AIM Act’s HFC regulations is critical for medical product importers, manufacturers, distributors and healthcare providers. The following key issues must be addressed:
Prohibition on Banned HFCs: Starting January 1, 2025, the distribution, sale, or importation of aerosol products containing specific banned HFCs is prohibited, as outlined in 40 CFR 84.54. This regulation targets products with high global warming potential (GWP) HFCs greater than 150 GWP, such as R404A and its components (HFC-143a, HFC-125, HFC-134a).
Legal Enforcement: Violations are subject to federal enforcement under Section 113 of the Clean Air Act, which includes potential fines and legal action. The EPA’s enforcement mechanisms are detailed in their Enforcement of the American Innovation and Manufacturing Act of 2020. Such penalties can be as much as $25,000 per event.
Product Assessment: Distributors and providers must evaluate their inventory to determine if products are aerosols and contain banned HFCs. Non-aerosol products or those using non-HFC gases (e.g., Nitrous Oxide, Carbon Dioxide) are not subject to these restrictions.
Documentation and Exemptions: For other products that are exempt, such as those confirmed by the EPA in 2022 (e.g., Histofreezer FLEX as not an aerosol), maintaining official documentation is essential to avoid compliance issues.
Recent updates, such as the EPA’s Regulatory Actions for Technology Transitions, indicate ongoing efforts to refine these restrictions, with compliance deadlines varying by sector and subsector, ranging from January 1, 2025, to January 1, 2028. Aerosol enforcement of the regulations started on January 1, 2025.
A List of Affected Cryosurgical Products that are known to contain banned HFCs and identify themselves as aerosols is shown below.
The EPA, in the AIM Act, has identified specific products by category and more broadly those that are aerosols and contain banned HFCs, prohibiting their import, manufacture, and distribution starting January 1, 2025. Any distributors or users of these products should confirm the information shown in the table.
| Category | Product Name | Details |
|---|---|---|
Contains Banned HFCs & Aerosol Spray |
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Contains R404A (Mixture of HFC-143a + HFC-125 + HFC-134a), banned aerosol.D510(K) Summary/SDS |
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Contains R404A, banned aerosol.510(K) Summary/SDS |
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Contains R404A, banned aerosol.510(K) Summary/SDS |
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Contains R404A, banned aerosol. |
| Category | Product Name | Details |
|---|---|---|
Exempted Products |
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Uses Dimethyl ether, Propane, Isobutane; not affected. |
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EPA Exempted as non-Aerosol |
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Uses Nitrous Oxide; Exempted Non-HFC |
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Uses Carbon Dixide; Exempted Non-HFC |
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Uses Nitrous Oxide or Carbon Dioxide; Exempted Non-HFC |
Schedule of Fines
Violations of the AIM Act’s HFC regulations are subject to penalties under Section 113 of the Clean Air Act. While specific fine amounts are not detailed in the provided summary, the EPA enforces these regulations federally, and non-compliance can result in significant financial and legal consequences. For precise details on potential fines, stakeholders are advised to refer to the EPA’s official documentation or contact the EPA directly, as outlined in their Protecting Our Climate by Reducing Use of HFCs page.
Next Steps for Medical Product Distributors and Healthcare Providers
To ensure compliance with the AIM Act’s HFC regulations, medical product distributors and healthcare providers should take the following detailed actions:
Review Product Compliance:
- Immediately assess inventory to identify any aerosol products containing banned HFCs (e.g., R404A). Discontinue the distribution, sale, or importation of banned products.
Update Supply Chains:
- Work with suppliers to transition to compliant alternatives or products using exempted gases.
- Collaborate with industry stakeholders to adopt climate-friendly technologies, as encouraged by the Understanding the AIM Act, Phases 1-3.
Train Staff:
- Educate all personnel on the new regulations, compliance deadlines, and the potential penalties for non-compliance. Provide training on how to identify banned products and handle compliance-related inquiries, leveraging resources from the EPA’s Frequent Questions on the Phasedown of Hydrofluorocarbons.
Monitor Regulatory Updates:
- Regularly check the EPA’s website (40 CFR 84.54) and official announcements for any further changes or guidance related to HFC regulations. Stay informed about any additional sector-specific restrictions or updates, as detailed in the Federal Register :: Phasedown of Hydrofluorocarbons.
Prepare for Supply Limitations & Enforcement:
- Establish internal processes to ensure compliance and avoid violations. Be prepared for potential audits or inquiries from regulatory authorities, as outlined in the EPA’s Enforcement of the American Innovation and Manufacturing Act of 2020. Avoid potential issues and migrate to products that are exempt from the AIM regulations.
By proactively addressing these compliance issues, medical product distributors and healthcare providers can ensure supply, mitigate risks, avoid penalties, and contribute to the broader goal of reducing environmental harm caused by HFCs, aligning with the EPA’s mission as described in Protecting Our Climate by Reducing Use of HFCs.
Conclusion
This regulatory update underscores the importance of compliance with the AIM Act’s HFC phasedown for medical product distributors and healthcare providers. By following the outlined steps and leveraging EPA resources, stakeholders can ensure adherence to environmental regulations while maintaining operational continuity. For further assistance, consult the EPA’s official channels and stay informed about ongoing developments in HFC regulations.
Each Distributor and Health Care Provider can take action if someone is violating the AIM Act. If you have information about violations of the AIM Act and its implementing regulations, please report it: https://echo.epa.gov/report-environmental-violations.
Key Citations
- Background on HFCs and the AIM Act, detailing environmental impact and regulatory framework
- Protecting Our Climate by Reducing Use of HFCs, overview of EPA’s HFC management strategies
- Regulatory Actions for Technology Transitions, updates on sector-specific HFC restrictions
- Federal Register :: Phasedown of Hydrofluorocarbons, detailing restrictions and compliance dates
- Frequent Questions on the Phasedown of Hydrofluorocarbons, guidance for compliance and exemptions
- Understanding the AIM Act, Phases 1-3, comprehensive overview of HFC phasedown plan