
EPA Flags Unreasonable Risk from D4 in Industrial and Environmental Use
EPA draft risk evaluation finds octamethylcyclotetrasiloxane (D4) poses significant risks to workers and aquatic life, signalling regulatory change for industry.


The U.S. Environmental Protection Agency (EPA) announced today the finalization of a revised rule that strengthens its process for conducting risk evaluations of chemicals under the Toxic Substances Control Act (TSCA). This update is pivotal in advancing chemical safety, ensuring comprehensive evaluations, and solidifying protections for public health.
Assistant Administrator Michal Freedhoff emphasized that the rule modification is grounded in robust science to safeguard the nation, including workers and communities, from toxic chemical exposures. The revisions were influenced by prior legal challenges and aim to create a more effective and transparent risk evaluation process.
The new rule mandates a thorough approach to risk evaluations. It includes:
The EPA commits to using the best available science for these evaluations, ensuring peer-reviewed processes align with federal and EPA-specific guidance. The rule also introduces fit-for-purpose approaches, allowing for variable analysis levels based on the potential risk posed by the conditions of use.
New procedures and criteria are set for revising scope and risk evaluation documents to enhance transparency. Additionally, the rule aligns manufacturer requests for evaluations with EPA-initiated evaluations, ensuring timely and informed decision-making.
All risk evaluations initiated 30 days post-publication will adhere to these updated procedures. For ongoing evaluations, the EPA aims to apply these new standards wherever practicable, respecting statutory limits and timelines.
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EPA draft risk evaluation finds octamethylcyclotetrasiloxane (D4) poses significant risks to workers and aquatic life, signalling regulatory change for industry.

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