USA TSCA Compliance by Polymers: Make No Detours!
Recently, many Chinese manufacturers with the intention of exporting polymers to the United States turned to REACH24H for help, seeking for a better understanding of regulatory obligations and possible ways of polymer exemption under U.S. Toxic Substances Control Act (TSCA). In response to such customer demands, REACH24H provided customers with exclusive compliance reports based on their product information, evaluating if the polymer exemption criteria were well met and pointing out ways to proceed.
TSCA Section Five stipulates that for companies intending to manufacture or import a new chemical substance in the United States for commercial purposes, a PMN (Pre-Manufacturing Notice) must be submitted to the U.S. Environmental Protection Agency (EPA) at least 90 days before manufacturing, importing, processing, or selling this specific new chemical substance. However, EPA found from years of experience in PMN reviews that some polymers, despite being new substances, were most unlikely to present an unreasonable risk of injury to human health or the environment. Therefore, polymer exemption criteria were thereafter established and the burden of deciding if a polymer could be exempted under TSCA was shifted from EPA to companies. In doing so, polymers not listed on the TSCA Inventory can still enter the U.S. market without a PMN submission if all the polymer exemption criteria were well met.
The Polymer Exemption Guidance Manual issued by EPA stipulates that to be eligible for the exemption, a new chemical substance must: meet the polymer definition, not be excluded and meet one of the three exemption criteria. Specifically, the eligible criteria for Polymer Exemption under TSCA include: 1) polymers with a number-average molecular weight (NAVG MW) of 1,000 daltons or greater and less than 10,000 daltons, with restrictions on low MW species and reactive functional groups; 2) polymers with a number-average molecular weight (NAVG MW) of 10,000 daltons or greater, with restrictions on low MW species. Polymers ineligible for exemption include those which degrade, decompose, or depolymerize, and polymers that are prepared from monomers or other reactants that are not on the TSCA Inventory, as are water-absorbing polymers with a number-average MW equal to or greater than 10,000 etc. It is also worth mentioning that the Polymer Exemption cannot be used for a material which contains a non-Inventory monomer or reactant.
Although a polymer meeting the exemption criteria can exempt from a PMN submission, there are still other regulatory obligations that must be fulfilled such as making a certification statement, record keeping and reporting. REACH24H believes that the polymer issue can be both simple and somewhat complicated, depending on whether or not a polymer exemption is possible, hence the need for comprehensive analysis of the specific product under TSCA.
Chemical Regulatory Specialist
REACH24H Consulting Group
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