November 2020

Risk Management under TSCA…….What companies should know

In 2019, the U.S. Environmental Protection Agency (EPA) issued a final rulei to prohibit the manufacture, import, processing and distribution of methylene chloride in all paint removers for consumer use. This rule was the EPA’s first regulation of a chemical under Section 6 of the Toxic Substances Control Act (TSCA) in almost 30 years, marking a milestone for the EPA. However, methylene chloride has many other applications than in paint remover, so what about these other uses?

To address this question, the EPA recently completed a risk evaluation of methylene chlorideii under the new TSCA to assess the remaining ways the chemical could be used or manufactured. This evaluation determined that there are additional uses of methylene chloride that pose unreasonable risks to human health or the environment; the EPA is moving into the risk management phase to determine how to best mitigate these risks.

The EPA has several options for how to address an unreasonable risk, including the following or a combination thereof:

• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce.
• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce for a particular use or for use above a set concentration.
• Require minimum warnings and instructions with respect to use, distribution and/or disposal.
• Require recordkeeping, monitoring or testing.
• Prohibit or regulate manner or method of commercial use.
• Prohibit or regulate manner or method of disposal by certain persons.
• Direct manufacturers/processors to give notice of the unreasonable risk determination to  istributors, users and the public, and replace or repurchase.

The EPA has only one year to address all identified unreasonable risks and another year to finalize the risk management rule. This will be based on information gathered during the risk evaluation, unless the EPA is provided with updated information from stakeholders.

In promulgating any rule under TSCA, the EPA must publish a statement, based on reasonably available information, about both the effects and magnitude of exposure to the chemical to human health and the environment, as well as the benefits of the chemical for various conditions of use. The EPA must also consider reasonably ascertainable economic consequences of the rule, including its impact (if any) on the national economy, small businesses or technological innovation. It must also consider the costs, benefits and cost- effectiveness of the proposed and final regulatory action and one or more primary regulatory alternatives.

Methylene chloride is one of the many chemicals to undergo the risk assessment and risk management process. In this case, if you use methylene chloride—or, in the future, another chemical that is determined to pose one or more unreasonable risks—you should discuss it with the EPA.

EPA staff has been meeting with associations and companies, including the Household & Commercial Products Association (HCPA), to help gather information and navigate the risk management process for methylene chloride (and 1-bromopropane).

The EPA is currently encouraging one-on-one meetings with stakeholders to help inform the risk management process and discuss how certain chemicals are used in products, especially by the end user, in order to fully understand the impacts of a final rule or regulation. For example, information regarding the essential uses of a chemical, or the consequences if a chemical were no longer available, is crucial. Even if a company is phasing out the use of a chemical undergoing risk management, it is important to address this with the EPA to help the Agency understand the changing market and how long certain chemical transitions may take.

Industry is the expert on its product formulations, so discussing potential alternatives, or lack thereof, is critical to assist the EPA in making risk management decisions. Ultimately, conversations between the EPA and industry can help ensure that both parties are properly informed, allowing the Agency to make better decisions about a chemical’s risk and companies to understand this process and make better business decisions.

The EPA’s regulation to ban the use of methylene chloride in all paint removers for consumer use was just the start. It will propose and finalize additional rules to address the unreasonable risks that were identified in their subsequent risk evaluations. For more information about methylene chloride, TSCA or how to meet with the EPA, email [email protected]. SPRAY

i Regulation of Paint and Coating Removal for Consumer Use: Methylene
Chloride is available here

ii Final Risk Evaluation for Methylene Chloride is available here