Assessment of Premanufacture Number (PMN) P-18-0378 under TSCA Section 5(a)(3)(C)
The U.S. Environmental Protection Agency (EPA) has published a TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0378. This determination is a key component of the EPA's review process for new chemical substances, aimed at assessing potential risks to health and the environment.
The document, available as a pdf file with a size of 256.23 KB, is a public document that can be accessed by anyone. It was published in July, 2020, and it does not contain any Confidential Business Information (CBI) or advertisements.
Under TSCA Section 5(a)(3)(C), the EPA must make an affirmative risk determination on 100% of new chemical PMNs submitted since the 2016 TSCA amendments. This includes a thorough review of available data to determine whether the chemical is expected to present an unreasonable risk under the conditions of use.
The TSCA review process typically involves a 90-day review period during which the EPA evaluates potential health, environmental, and exposure risks, often applying the best available science. If the EPA determines risks exist, it may impose conditions or restrictions on manufacture and use. Alternatively, if no unreasonable risk is found, manufacture and processing can proceed. In some cases, the EPA may require additional data or testing.
For PMNs like P-18-0378, the EPA would have completed this risk assessment and issued a determination within 90 days. If subject to a Significant New Use Rule (SNUR), further review or notification requirements could apply.
While the specific determination text for PMN P-18-0378 is not detailed in the search results, you can find the precise text and conditions of the determination by checking EPA’s official New Chemicals Database or the Federal Register notices where these determinations and related SNURs are published.
In summary, the TSCA Section 5(a)(3)(C) determination for PMN P-18-0378 is the EPA's formal risk assessment decision, concluding whether or not the chemical may be manufactured or processed without presenting an unreasonable risk. This decision is informed by the agency's risk evaluation under amended TSCA requirements.
- The TSCA Section 5(a)(3)(C) determination for PMN P-18-0378 is significant in the field of health and wellness, as it concerns a new chemical substance and evaluates potential risks to human health.
- The review process for PMN P-18-0378, falling under the domain of science, involves an evaluation of its impact on environmental-science, focusing on potential risks to the environment, health, and exposure during manufacture and use.
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