
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) has granted a petition to regulate the manufacturing, processing, use, distribution, and disposal of certain per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. The petition, filed under the Toxic Substances Control Act (TSCA) Section 21, was submitted by a coalition of environmental groups and advocates, including Earthjustice, the Center for Environmental Health, and Public Employees for Environmental Responsibility.
The petition, received by the EPA on 11 April 2024, calls for strict regulation of three specific PFAS—perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA). These substances are known to form during the fluorination process of plastic containers, a common practice intended to enhance the durability and chemical resistance of these containers.
PFAS are often referred to as "forever chemicals" due to their extreme persistence in the environment and ability to bioaccumulate in human and animal tissues. These substances have been linked to a range of serious health issues, including cancer, developmental harm, reproductive and immune system toxicity, and liver and kidney damage.
In a letter dated 10 July 2024, the EPA confirmed the decision to grant the petition and initiate rulemaking proceedings under TSCA Section 6. This marks a significant step in regulating the harmful impacts of PFAS formed during the plastic fluorination process.
"The EPA has reviewed the evidence provided in the petition and agrees that it is necessary to regulate these substances to protect human health and the environment," said Michal Freedhoff, Director of the EPA’s Office of Pollution Prevention and Toxics. "We will promptly commence proceedings to develop appropriate regulations."
The EPA's decision is based on extensive research and risk assessments, which have demonstrated that PFOA, PFNA, and PFDA are hazardous at low levels and pose significant risks through various exposure pathways, including groundwater contamination, leaching into food and beverages stored in fluorinated containers, and dermal absorption.
The regulation of PFAS in plastic fluorination is expected to have wide-reaching implications for industries relying on fluorinated plastic containers. Companies will need to explore alternative methods for enhancing the durability of their products without generating these harmful substances.
Environmental and health advocacy groups have welcomed the EPA’s decision. "This is a crucial victory for public health and the environment," said Kelly E. Lester, a counsel at Earthjustice. "The regulation of these dangerous chemicals will reduce exposure and prevent future harm to communities across the country."
The EPA will now begin the process of gathering information and stakeholder input to develop and implement the new regulations. This includes understanding the extent of PFAS use in plastic fluorination, identifying safer alternatives, and determining the most effective ways to mitigate the risks associated with these substances.
As part of its commitment to transparency and public engagement, the EPA will publish updates and solicit feedback throughout the rulemaking process. The agency aims to ensure that the final regulations are both scientifically sound and practical for implementation across affected industries.
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