TSCA Section 5 (a) (2)

TSCA Section 5 (a) (2) - Determination of new significant uses

• Section 5 (A) (2) of the TSCA empowers the EPA to determine what constitutes a "new significant use" of a chemical.
• The EPA considers several factors to make this determination, which include:
• The projected volume of manufacturing and processing of the chemical.
• The extent to which a use changes the type or form of exposure of humans or the environment to the chemical.
• The extent to which a use increases the magnitude and duration of the exposure of humans or the environment to the chemical.
• The reasonably planned manner and methods of manufacturing, processing, commercial distribution and elimination of a chemical.
• If it is determined that the use of a chemical is a "significant new use", a new significant use (SNUN) should be presented to the EPA at least 90 days before the start of manufacturing or processing.
• The US Environmental Protection Agency (EPA), under the toxic substance control law (TSCA), has the power to designate a chemical as "new significant use" (SNUN).
• If a chemical has been granted a SNUN designation, it means that the EPA has determined that the new use of the substance could cause environmental or health problems that were not considered in the initial review of the notice prior to manufacturing (PMN).
• The list of chemical substances with SNUN designations is continuously updated as new potential risks are identified and evaluated.The EPA maintains an inventory of TSCA chemicals, which includes all existing chemicals manufactured, processed or imported in the US. Many of these substances may have a SNUN designation under certain circumstances.

• For example, a chemical that originally occurred for use in industrial processes could receive a SNUN designation if a company planned to start using it in consumer products, due to the possibility of greater public exposure.

• The EPA, by virtue of the Toxic Substances Control Law (TSCA), designated certain chemical substances of the Long Chain Perfluoral Carboxylate (LCPFAC) as chemical substances of the rule of new significant use (SNUR).This was due to concerns about their possible environmental and health impacts.
• LCPFAC chemicals are part of the largest group of perfluoroalized substances (PFAS), which are known for their persistence in the environment, bioaccumulation potential and possible adverse effects for human health. These chemicals have been used in a wide variety of consumer products during the last 60 years, including antiatrating kitchen utensils, furniture and carpets resistant to spots, wrinkles resistant to water and repellent to water, and many other daily products.
• According to the SNUR provisions of the TSCA, manufacturers (including importers) must notify the EPA at least 90 days before manufacturing or processing the chemical for a new significant use. The required notification begins the EPA evaluation of the conditions of use associated with the new planned significant use.
• Then, the EPA has the opportunity to evaluate the planned use and, if necessary, prohibit or limit that activity before it occurs. This rule allows EPA to take measures to prevent or limit activities that can contribute to chemical risks before these risks occur.
• Therefore, if a manufacturer plans to use or manufacture LCPFAC substances in a new way, you must collect information and send it to the EPA as part of the SNUR process. This information could include data on chemical properties, environmental impacts, possible exposure routes and security measures that will be implemented to protect workers and the public.
• Perfluoroctanoic acid (PFOA) and its salts, which are part of the widest group of perfluoroalized substances (PFAS), have been identified by the US Environmental Protection Agency.(EPA) for new significant rules of use (SNUR) under the toxic substance control law.(TSCA).
• PFOA is an extremely persistent synthetic compound in the environment. It has been used in a wide variety of industrial and consumer products, including antiadherent kitchen utensils, fabrics and carpets resistant to spots, some food containers and specialized applications such as fire foams.
• There are several reasons why PFOA and its salts are subject to SNUR:
• Persistence: PFOA and its salts do not decompose naturally in the environment and, therefore, can remain there for a long time.
• Bioacumulation: These substances can accumulate in the body over time, increasing potential health risks.
• Potential health risks: exposure to PFOA has been associated with several health problems, including kidney cancer and testicle, thyroid diseases, liver damage and development problems.
• Environmental concerns: Due to their persistence, these substances can travel long distances in the environment, contaminating soil and water.
• According to the SNUR provisions of the TSCA, the manufacturers (including importers) of PFOA and their salts must notify the EPA at least 90 days before manufacturing, importing or processing the chemical for a new significant use. The required notification provides EPA for the opportunity to evaluate the planned use and, if necessary, prohibit or limit that activity before it occurs.

 

Ahmed Sakr

Product Compliance Consultant

Complymarket UG (haftungsbeschraenkt)