TSCA Article 5(a)(2)

TSCA Section 5(a)(2) - Identify important new uses

• Section 5(a)(2) of TSCA authorizes the EPA to determine what constitutes a “major new use” of chemical substances.
• The EPA considers several factors to make this decision, including:
• The estimated manufacturing and processing volume of chemical substances.
• Use to change the extent to which humans or the environment are exposed to chemicals.
• Use increases the extent and duration of exposure to chemicals by humans or the environment.
• Reasonable expected methods and methods for the manufacture, processing, commercial distribution and disposal of chemical substances.
• If the 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 starting manufacturing or processing.
• The U.S. Environmental Protection Agency (EPA) has the right to designate a chemical for "significant new uses" (SNUN) under the Toxic Substances Control Act (TSCA).
• If a chemical is awarded the SNUN title, it means that the EPA has determined that the new use of the substance may cause environmental or health issues that were not taken into account in the initial Pre-production Notice (PMN) review.
• As new potential risks are identified and evaluated, the list of chemicals with the SNUN name is constantly updated. The EPA maintains a list of TSCA chemical substances, which includes all existing chemicals made, processed or imported in the United States. Many of these substances can in some cases have an SNUN name.

• For example, if a company plans to start using a chemical originally used in a consumer product, the chemical may receive the SNUN title because the chemical may increase the likelihood of public contact.

• EPA designates certain long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals as important new rules of use (SNUR) chemicals under the Toxic Substances Control Act (TSCA). This is due to concerns about its potential environmental and health impacts.
• LCPFAC chemicals are part of perfluoroalkyl and polyfluoroalkyl substances (PFAS) that are well known for their persistence in the environment, potential bioaccumulativeness and potential adverse effects on human health. Over the past 60 years, these chemicals have been widely used in a variety of consumer products, including non-stick cookware, stain-proof furniture and carpets, wrinkle-proof and waterproof clothing, and many other everyday items.
• According to TSCA's SNUR regulations, manufacturers (including importers) must notify the EPA at least 90 days before manufacturing or processing chemicals for critical new uses. Required notifications initiate the EPA's assessment of usage conditions related to the expected new and important uses.
• The EPA then has the opportunity to assess the intended use and to prohibit or restrict the activity before it occurs if necessary. This rule allows EPA to take action before the risk occurs, preventing or limiting activities that may lead to chemical risks.
• Therefore, if manufacturers plan to use or manufacture LCPFAC substances in a new way, they need to collect information and submit it to the EPA as part of the SNUR process. This information may include data on chemical properties, environmental impacts, potential exposure pathways, and safety measures implemented to protect workers and the public.
• Perfluorooctanoic acid (PFOA) and its salts are part of perfluoroalkyl and polyfluoroalkyl substances (PFAS) and have been identified by the U.S. Environmental Protection Agency (EPA) as a key new use rule (SNUR) (TSCA) under the Toxic Substance Control Act.
• PFOA is a synthetic compound that has extremely persistence in the environment. It has been widely used in a variety of industrial and consumer products, including non-stick cookware, anti-fouling fabrics and carpets, some food packaging, and fire foams.
• PFOA and its salts are affected by SNUR for several reasons:
• Persistence: PFOA and its salts do not decompose naturally in the environment and therefore can remain in it for a long time.
• Bioaccumulation: These substances accumulate in the body over time, increasing potential health risks.
• Potential health risks: PFOA exposure is associated with a variety of health problems, including renal and testicular cancer, thyroid disease, liver damage and developmental problems.
• Environmental Issues: Due to its durability, these substances can spread over the environment for a long distance, contaminating soil and water.
• According to the SNUR regulations of TSCA, manufacturers of PFOA and its salts (including importers) must notify the EPA at least 90 days before manufacturing, importing or processing the chemical for important new uses. The required notice gives the EPA the opportunity to evaluate the intended use and prohibit or restrict the activity before it occurs if necessary.

 

Ahmed Sakr

Product Compliance Consultant

ComplyMarket UG (haftungsbeschraenkt)