TSCA Section 5(a)(2)

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

• Section 5(a)(2) of the TSCA empowers the EPA to determine what constitutes the "critical novel use" of chemicals.
• The EPA considers several factors to make this decision, including:
• Prediction of the production and processing volume of chemical substances.
• The extent to which the type or form of exposure to chemicals in the human body or environment changes with use.
• The extent of use increases the magnitude and duration of exposure to a human or environment to chemicals.
• Reasonably anticipated methods and methods of the manufacture, processing, commercial distribution, and disposal of chemicals.
• If the use of a chemical is deemed to be "significant new use," you must submit a significant new use notice (SNUN) to the EPA at least 90 days prior to the start of production or processing.
• The US Environmental Protection Agency (EPA) has the authority to designate chemicals as "critical new uses" (SNUN) under the Hazardous Substances Control Act (TSCA).
• If a chemical is given a SNUN designation, it means that the EPA has determined that new use of the substance may raise environmental or health concerns that were not considered in the initial pre-manufacturing notice (PMN) review.
• SNUN The list of designated chemicals is continuously updated as new potential risks are identified and evaluated. The EPA maintains a TSCA chemical inventory containing all existing chemicals manufactured, processed or imported in the United States. Many of these substances may be subject to SNUN designations under certain circumstances.

• For example, chemicals originally manufactured for use in industrial processes may be subject to SNUN designations as public exposure could increase if businesses plan to begin using them in consumer products.

• The EPA has designated certain long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals as key new use rules (SNUR) chemicals under the Hazardous Substances Control Act (TSCA). This was due to concerns about the potential impact on the environment and health.
• LCPFAC chemicals are part of a larger group of perfluoroalkyl and polyfluoroalkyl substances (PFAS), known for their environmental persistence, potential bioaccumulation, and potential adverse effects on human health. Over the past 60 years, these chemicals have been used in a variety of consumer products, including stick-resistant cooking utensils, stain-resistant furniture and carpets, wrinkle-resistant and water-repellent clothing, and many other daily necessities.
• Under the SNUR regulations of the TSCA, manufacturers (including importers) must notify the EPA at least 90 days prior to manufacturing or processing chemicals for important new uses. A required notice will begin the evaluation of the EPA of terms of use related to the intended important new use.
• The EPA has the opportunity to assess the purpose of use and, if necessary, have the opportunity to prohibit or limit the action before it is carried out. This regulation allows the EPA to take measures to prevent or limit activities that may contribute to chemical risk before the risk arises.
• Therefore, if the manufacturer plans to use or manufacture LCPFAC materials in a new way, the information must be collected and submitted to the EPA as part of the SNUR process. This information may include data on chemical properties, environmental impacts, potential exposure routes, and safety measures implemented to protect workers and the public.
• Perfluorooctanoic acid (PFOA) and its salts are part of a large group of perfluoroalkyl and polyfluoroalkyl substances (PFAS) and are designated by the US Environmental Protection Agency (EPA) in the Important New Use Rules (SNUR) under the Toxic Substances Control Act. (TSCA).
• PFOA is a synthetic compound with extremely high residual properties in the environment. It is used in a variety of industrial and consumer products, including special uses such as non-stick cooking utensils, stain-resistant fabrics and carpets, some food packaging, and fire-extinguishing foam.
• There are several reasons why PFOA and its salts are eligible for SNUR.
• Persistence: PFOA and its salts do not degrade naturally in the environment, and can remain there for a very long period of time.
• Bioaccumulation: These substances accumulate in the body over time, potentially increasing health risks.
• Potential health risks: Exposure to PFOA has been associated with several health problems, including kidney and testicular cancer, thyroid disease, liver damage, and developmental problems.
• Environmental concerns: These substances are persistent and can travel long distances throughout the environment and pollute soil and water.
• Under the SNUR regulations of the TSCA, the manufacturers of PFOA and its salts (including importers) must notify the EPA at least 90 days prior to manufacturing, importing or processing chemicals for important new uses. A necessary notice will give the EPA an opportunity to evaluate the purpose of use and, if necessary, prohibit or restrict the actions before they occur.

 

Ahmed Sakr

Product Compliance Consultant

ComplyMarket UG (Haftungsbeschraenkt)