Pressure Points
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 distributors, 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 ngeorges@thehcpa.org. Spray
i Regulation of Paint and Coating Removal for Consumer Use: Methylene
Chloride is available at https://www.regulations.gov/document?D=EPA_FRDOC_
0001-23648
iiFinal Risk Evaluation for Methylene Chloride is available at https://www.
epa.gov/sites/production/files/2020-06/documents/1_mecl_risk_evaluation_
final.pdf
10 Spray November 2020
NICHOLAS GEORGES
HCPA VP of Scientific
& International Affairs
ngeorges@thehcpa.org
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...