TSCA, oddíl 5(a)(2)

TSCA Section 5(a)(2) - Determining Significant New Uses

• Section 5(a)(2) of the TSCA empowers the EPA to determine what constitutes a "significant new use" for a chemical substance.
• The EPA considers several factors to make this determination, including:
  • The projected volume of manufacturing and processing of the chemical substance.
  • The extent to which a use changes the type or form of exposure of humans or the environment to the chemical substance.
  • The extent to which a use increases the magnitude and duration of exposure of humans or the environment to the chemical substance.
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
• If a use of a chemical substance is determined to be a "significant new use", a Significant New Use Notice (SNUN) must be submitted to the EPA at least 90 days before the start of manufacturing or processing.
• The Environmental Protection Agency (EPA) in the U.S. under the Toxic Substances Control Act (TSCA) has the power to designate a chemical as having a "Significant New Use" (SNUN).
• If a chemical has been given a SNUN designation, it means that the EPA has determined that the substance's new use could potentially cause environmental or health concerns that weren't considered in the initial pre-manufacture notice (PMN) review.
• The list of chemicals with SNUN designations is continually updated as new potential risks are identified and assessed. The EPA maintains a TSCA Chemical Substance Inventory, which includes all existing chemical substances manufactured, processed, or imported in the U.S. Many of these substances can have a SNUN designation under certain circumstances.
  • For example, a chemical that was originally produced for use in industrial processes might receive a SNUN designation if a company planned to start using it in consumer products, due to the potential for increased exposure to the public.
• The EPA under the Toxic Substances Control Act (TSCA) designated certain Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) chemical substances as Significant New Use Rule (SNUR) chemicals. This was due to concerns about their potential environmental and health impacts.
• LCPFAC chemicals are part of the larger group of Per- and Polyfluoroalkyl Substances (PFAS), which are known for their persistence in the environment, bioaccumulation potential, and potential adverse human health effects. These chemicals have been used in a wide variety of consumer products over the past 60 years including non-stick cookware, stain resistant furniture and carpets, wrinkle-free and water repellant clothing, and many other everyday products.
• Under the SNUR provisions of TSCA, manufacturers (including importers) are required to notify the EPA at least 90 days before they manufacture or process the chemical substance for a significant new use. The required notification initiates EPA’s evaluation of the conditions of use associated with the intended significant new use.
• The EPA then has the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. This rule allows EPA to take action to prevent or limit activities that may contribute to chemical risks prior to those risks occurring.
• So, if a manufacturer is planning to use or manufacture LCPFAC substances in a new way, they would need to collect information and submit it to the EPA as part of the SNUR process. This information might include data about the chemical properties, environmental impacts, potential exposure pathways, and safety measures that will be implemented to protect workers and the public.
• Perfluorooctanoic Acid (PFOA) and its salts, part of the larger group of Per- and Polyfluoroalkyl Substances (PFAS), have been identified by the U.S. Environmental Protection Agency (EPA) for Significant New Use Rules (SNUR) under the Toxic Substances Control Act (TSCA).
• PFOA is a synthetic compound that is extremely persistent in the environment. It has been used in a wide variety of industrial and consumer products including non-stick cookware, stain-resistant fabric and carpet, some food packaging, and specialized applications like firefighting foams.
• There are several reasons why PFOA and its salts are subject to SNUR:
  • Persistence: PFOA and its salts do not break down naturally in the environment and thus can remain there for a very long time.
  • Bioaccumulation: These substances can accumulate in the body over time, increasing potential health risks.
  • Potential Health Risks: PFOA exposure has been associated with several health issues, including kidney and testicular cancer, thyroid disease, liver damage, and developmental issues.
  • Environmental Concerns: Because of their persistence, these substances can travel long distances in the environment, contaminating soil and water.
• Under the SNUR provisions of TSCA, manufacturers (including importers) of PFOA and its salts are required to notify the EPA at least 90 days before they manufacture, import, or process the chemical substance for a significant new use. The required notification provides the EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

 

Ahmed Sakr

Product Compliance Consultant 

ComplyMarket UG (haftungsbeschraenkt)