Determination under TSCA Section 5(a)(3)(C) for Premanufacture Numbers (PMNs) P-17-0347, P-17-0348, P-17-0349, P-17-0350, P-17-0351, and P-17-0352
The Environmental Protection Agency (EPA) has made a significant step in the regulatory process for six chemicals under the amended Toxic Substances Control Act (TSCA). In August 2019, the EPA conducted a review of pre-manufacture notices (PMNs) for chemicals P-17-0347, P-17-0348, P-17-0349, P-17-0350, P-17-0351, and P-17-0352.
The EPA's TSCA Section 5(a)(3)(C) Determination for these PMNs is a crucial part of the regulatory process for new chemical substances. This determination evaluates whether the manufacture, import, or processing of these chemicals may present an unreasonable risk or not.
In this case, the EPA's review found that the manufacture, import, or processing of these chemicals does not pose an unreasonable risk of injury to health or the environment. Consequently, the EPA's determination allows for the manufacture, import, or processing of these chemicals for research and development purposes.
It is important to note that this determination does not authorize the commercial manufacture, import, or processing of the listed chemicals. For commercial use, companies would need to comply with other TSCA regulations and potential additional approvals.
The document detailing this determination is available as a PDF file, weighing 92.97 KB. Notably, the review findings for these chemicals do not contain confidential business information (CBI).
For those interested in finding the exact TSCA Section 5(a)(3)(C) Determination for these PMNs, it is recommended to consult the EPA's premanufacture notice (PMN) review records or official Federal Register notices detailing these particular PMNs. These records usually state whether EPA issued a “not likely to present an unreasonable risk” determination or imposed restrictions.
In summary, the EPA's TSCA Section 5(a)(3)(C) Determination for PMNs P-17-0347 through P-17-0352 issued under the amended TSCA in August 2019 is a significant milestone in the regulatory process for these chemicals. The document detailing this determination can be found on the EPA's official website.
The EPA's regulatory process for chemicals P-17-0347 through P-17-0352 under the amended TSCA indicates that they are safe for research and development purposes in health-and-wellness and environmental-science fields, as the EPA's determination found no unreasonable risk of injury to health or the environment. However, commercial manufacturing, importing, or processing of these chemicals requires compliance with other TSCA regulations and potential additional approvals.
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