TSCA, article 5 (a) (2)

TSCA Section 5 (A) (2) - Determination of new important uses

• Article 5 (A) (2) of the TSCA empowers the EPA to determine what constitutes a "new important use" of a chemical substance.
• EPA takes into account several factors to make this decision, in particular:
• The projected volume of manufacturing and processing of the chemical.
• The extent to which use modifies the type or form of exposure of humans or the environment to the chemical.
• The extent to which use increases the magnitude and duration of humans' exposure or the environment to the chemical.
• The reasonably planned manner and methods of manufacturing, processing, commercial distribution and elimination of a chemical substance.
• If the use of a chemical substance is considered to be a "new important use", a new notice of new use (SNUN) must be subject to EPA at least 90 days before the start of manufacturing or transformation.
• The Environmental Protection Agency (EPA) of the United States, under the law on the control of toxic substances (TSCA), has the power to designate a chemical as having "new important use" (SNUN).
• If a chemical has received an SNUN designation, this means that EPA has determined that the new use of the substance could potentially cause environmental or health problems which were not taken into account during the initial examination of the prior notice to manufacturing (PMN).
• The list of chemicals bearing the Snun designation is continuously updated as new potential risks are identified and evaluated. EPA holds an inventory of TSCA chemicals, which includes all existing chemicals made, treated or imported in the United States. Many of these substances may have an Snun designation in certain circumstances.

• For example, a chemical initially produced to be used in industrial processes could receive an Snun designation if a company was planning to start using it in consumer products, due to the risk of increased public exposure.

• The EPA, under the law on the control of toxic substances (TSCA), has designated certain chemicals of the long -chain perfluoroalkyle carboxylate (LCPFAC) as chemicals relating to the significant new use rule (SNUR). This was due to concerns about their potential environmental and health impacts.
• LCPFAC chemicals are part of the wider group of per- and polyfluoroalkyle (PFAS) substances, known for their persistence in the environment, their bioaccumulation potential and their potential harmful effects on human health. These chemicals have been used in a wide variety of consumer products in the past 60 years, including non -stick kitchen utensils, furniture and stains resistant carpets, unsightly and water -repellent clothes and many other daily products.
• Under the SNUR provisions of the TSCA, manufacturers (including importers) are required to inform EPA at least 90 days before manufacturing or transforming the chemical for new significant use. The required notification launches the evaluation by the EPA of the conditions of use associated with the new important use provided.
• The EPA then has the possibility of assessing the expected use and, if necessary, of prohibiting or limiting this activity before it occurs. This rule allows the EPA to take measures to prevent or limit activities likely to contribute to chemical risks before these risks occur.
• Thus, if a manufacturer plans to use or manufacture LCPFAC substances in a new way, it will have to collect information and subject it to EPA as part of the SNUR process. This information may include data on chemical properties, environmental impacts, potential exposure routes and security measures that will be implemented to protect workers and the public.
• Perfluorooctanoic acid (PFOA) and its salts, which are part of the wider group of per- and polyfluoroalkyle (PFAS) substances, have been identified by the American environmental protection agency (EPA) for the rules of new significant use (SNUR) under the law on the control of toxic substances.(TSCA).
• PFOA is an extremely persistent synthetic compound in the environment. It has been used in a wide variety of industrial and consumption products, including non-stick kitchen utensils, stains resistant fabrics and carpets, certain food packaging and specialized applications such as anti-initia mosses.
• There are several reasons why the PFOA and its salts are subject to SNUR:
• Persistence: the PFOA and its salts do not decompose naturally into the environment and can therefore stay there very long.
• Bioaccumulation: These substances can accumulate in the body over time, thus increasing the potential risks to health.
• Potential health risks: exposure to APFO has been associated with several health problems, including kidney cancer and testicles, thyroid diseases, liver damage and development problems.
• Environmental concerns: due to their persistence, these substances can travel long distances in the environment, contaminating the soil and water.
• Under the SNUR provisions of TSCA, manufacturers (including importers) of PFOA and its salts are required to inform EPA at least 90 days before manufacturing, importing or transforming the chemical for a new significant use. The required notification gives the EPA the possibility of assessing the expected use and, if necessary, of prohibiting or limiting this activity before it occurs.

 

Ahmed Sakr

Product Compliance Consultant

Complymarket UG (Beschraenkt)