New EPA Regulation: Implications of Methylene Chloride Restrictions

The US Environmental Protection Agency (EPA) has finalized a regulation under the Toxic Substances Control Act (TSCA) that significantly limits the use of methylene chloride, a widely used solvent with considerable health risks. This rule represents a critical step in EPA’s ongoing efforts to ensure chemical safety and protect worker health, especially in industries that widely use methylene chloride.

Understanding TSCA: A Foundation for Chemical Safety

Before diving into the recent regulatory updates, it’s important to understand the framework of the Toxic Substances Control Act (TSCA). It serves as the foundation of chemical safety regulation in the United States. Passed in 1976, TSCA gives the Environmental Protection Agency (EPA) the authority to assess, regulate, and manage the risks posed by chemicals in commerce. Its goal is to prevent unreasonable risks to human health and the environment without hindering innovation and economic growth.

Furthermore, TSCA was significantly revised in 2016 through the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This revision enhanced EPA’s ability to evaluate new and existing chemicals and enforce compliance with stricter safety standards. This amendment aimed to provide a more robust, transparent, and science-based process for chemical assessment and regulation.

Overview of the New EPA Regulation

The recent regulation limits the use of methylene chloride to a select few industrial applications. It imposes stringent controls to manage its risks effectively. Out of more than fifty identified uses, the rule now prohibits all consumer applications. Additionally, it restricts many others, permitting only thirteen specific conditions of use under tightly controlled environments.

Elements of the EPA Regulation

• Phased Implementation: The rule introduces a phased timeline starting with distribution prohibitions, gradually extending to broader usage restrictions.
• Workplace Chemical Protection Program (WCPP): A handful of uses deemed highly industrialized will continue under stringent safety measures, including adherence to an exposure limit of 2ppm over an eight-hour period, periodic monitoring, and detailed record-keeping.

Industry Adjustments and Compliance

Several industry concessions have been made following feedback from the April 2023 proposal:

• Extended Compliance Timelines: The rule now allows additional time for companies to comply with the new requirements. This extends the timeline for implementing safety protocols.
• De Minimis Threshold: A new threshold of 0.1% for methylene chloride in formulations has been established. This helps industries adjust their processes to comply with the rule.

Special Exemptions and Adjustments

• Critical Use Exemption: The rule includes a ten-year exemption for essential applications. This exemption notably applies to projects by the National Aeronautics and Space Administration (NASA).
• Pharmaceutical Applications: The use of methylene chloride in pharmaceuticals, which accounts for a substantial part of its annual production, is not covered by this rule. This exemption is due to these applications falling outside the regulatory scope of TSCA.

Implications for Industries Regarding EPA Regulation

Industries affected by the new rule will need to reevaluate their operational strategies. Specifically, sectors such as aerospace, automotive, and engineering, which use methylene chloride in critical applications, are impacted. As a result, these industries must adapt to meet the new requirements. The rule’s focus on reducing exposure through stringent workplace safety measures emphasizes EPA’s commitment to controlling unreasonable risks associated with chemical use.

How Lisam Facilitates Compliance with New Regulations?

At Lisam, we understand the complexities and challenges these regulatory changes bring. Our ExESS software plays a crucial role in helping businesses navigate and comply with these new regulations efficiently. Here’s how we support your compliance efforts:

• Regulatory Data Management: Our team continuously curates and updates a comprehensive library of regulatory lists including the TSCA lists, ensuring you have access to the latest safety data sheet (SDS) compliance requirements.
• Seamless Integration: ExESS makes this regulatory content readily available, enabling you to leverage data updates effortlessly.
• Advanced Gap Analysis Tools: Our software helps you understand and anticipate the impacts of regulatory updates on your products, ensuring you remain ahead in compliance.

Looking Ahead

The finalization of this rule under the TSCA amendments reinforces EPA’s reliance on regulatory measures to mitigate health risks. It also reflects an evolving approach towards chemical regulation, balancing industry needs with public health and safety imperatives.

As the TSCA risk management program evolves, Lisam remains committed to providing the tools and expertise necessary to effectively navigate these changes. Staying ahead of regulatory shifts is crucial for maintaining compliance and ensuring safety across all operations.

Source: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-methylene-chloride