Pre-manufacture Notice (PMN) P-18-0137 under TSCA Section 5(a)(3)(C) Determination Announced
The Environmental Protection Agency (EPA) has made public the TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0137. This regulatory document, released on October 5, 2018, is a decision regarding the manufacturing of a specific chemical substance.
The TSCA Section 5(a)(3)(C) Determination for PMN P-18-0137 is a 59.88 KB document available in pdf format. It provides information about the EPA's review of the chemical substance associated with PMN P-18-0137. Notably, the determination does not contain any Confidential Business Information (CBI) that was previously marked as such.
This determination under Section 5(a)(3)(C) of the Toxic Substances Control Act (TSCA) evaluates whether the new chemical presents an unreasonable risk or if regulation under TSCA is necessary before manufacturing or processing can proceed. The review assesses if there is a need for restriction or additional testing before manufacture, or if the chemical can be safely manufactured and marketed under the conditions proposed.
Typically, the EPA either imposes certain restrictions or testing requirements or takes a "not likely to present an unreasonable risk" stance, allowing manufacture to proceed (often with recordkeeping or reporting requirements). To find the precise details of the TSCA Section 5(a)(3)(C) determination for PMN P-18-0137, such as the decision outcome, risk assessment summary, or any restrictions, one would typically refer to the official EPA docket or Federal Register notice related to that PMN.
It is important to note that the TSCA Section 5(a)(3)(C) determination for PMN P-18-0137 is a public document and can be accessed by anyone. The document details EPA's review determination under the amended TSCA for P-18-0137.
If you require further information about the typical process or how this determination impacts the chemical's commercialization, feel free to ask. However, I do not have direct access to the specific EPA decision text for PMN P-18-0137.
The TSCA Section 5(a)(3)(C) Determination for PMN P-18-0137 encompasses a review of the chemical's potential impact on health-and-wellness, medical-conditions, and the environment, given it is part of the realm of environmental science. This public document, recently available for download, details if the chemical substance associated with PMN P-18-0137 can be safely manufactured and marketed, or if regulation under TSCA is necessary, as it may present an unreasonable risk.
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