Chemical Premanufacture Notification (PMN) P-20-0035 Decision Under Toxic Substances Control Act (TSCA) Section 5(a)(3)(C)
The Environmental Protection Agency (EPA) has made a positive determination for Premanufacture Number (PMN) P-20-0035, a new chemical substance, under the Toxic Substances Control Act (TSCA). This decision, made under the amended TSCA, means that the chemical substance in question is not expected to pose an unreasonable risk to human health or the environment under the conditions of use described in the PMN.
In accordance with Section 5(a)(3)(C) of TSCA, the EPA reviewed a premanufacture notice (PMN) submitted for the new chemical and determined that it can be manufactured, imported, or processed as proposed without further restrictions or regulatory actions under TSCA Section 5.
The EPA's decision comes after a thorough review process, during which the agency evaluated the potential risks associated with the new chemical substance. The review determination, a formal document published as a pdf file with a size of 185.66 KB, does not contain confidential business information (CBI) and is publicly available.
The review determination for PMN P-20-0035 was published in July, 2020. This means that the manufacturer can now proceed with commercial manufacture and import according to the submitted intended uses, providing they adhere to the conditions outlined in the PMN and the EPA's decision.
For those seeking more detailed information about the EPA's exact language or risk assessment, this data can typically be found in the Federal Register or EPA’s New Chemicals program documents related to PMN P-20-0035.
The EPA's decision on PMN P-20-0035 signifies that this new chemical substance, falling under the sphere of environmental science, is not anticipated to pose a significant risk to health-and-wellness or the environment. In line with the Toxic Substances Control Act (TSCA), the EPA has determined that the new chemical can be manufactured, imported, or processed without additional restrictions.