Assessment of Premanufacture Number (PMN) P-16-0313 under TSCA Section 5(a)(3)(C)

Assessment of Premanufacture Number (PMN) P-16-0313 under TSCA Section 5(a)(3)(C)

The United States Environmental Protection Agency (EPA) has released its formal review determination for Premanufacture Number (PMN) P-16-0313 under the amended Toxic Substances Control Act (TSCA). This determination, which is a crucial step in the EPA's evaluation of new chemicals, outlines the agency's risk evaluation and regulatory decision regarding the chemical.

Under TSCA Section 5, the EPA is required to review each PMN and make an affirmative risk determination within 90 days. This decision determines whether the chemical presents an unreasonable risk or if any regulatory restrictions are necessary before manufacture can commence. The EPA evaluates potential health and environmental risks using the best available science and may impose restrictions, significant new use rules (SNURs), or deny the PMN accordingly.

The review process for new chemicals like PMN P-16-0313 involves a 90-day review period starting from PMN submission. The EPA considers available data on hazards, exposures, and intended conditions of use. If risks are identified, regulatory controls or risk management measures are imposed, and the determinations are published. These publications may include no further action, restrictions, or other risk mitigation requirements.

However, a direct search for the detailed, substance-specific determination for PMN P-16-0313 did not yield immediate results in the recent federal developments or EPA New Chemicals Program updates available.

Despite this, it is known that the TSCA Section 5(a)(3)(C) Determination for PMN P-16-0313 was issued as a pdf document, weighing 189.27 KB, and was released in June, 2020. It is also worth noting that this review determination does not contain Confidential Business Information (CBI).

Without direct access to the EPA’s public docket or Federal Register notice for P-16-0313, the exact content of this determination cannot be confirmed from the provided information. However, the release of this determination marks a significant step forward in the EPA's ongoing efforts to ensure the safety of new chemicals entering the market.

[1] Toxic Substances Control Act (TSCA) - United States Environmental Protection Agency (EPA) [2] New Chemicals Program - United States Environmental Protection Agency (EPA)

The Toxic Substances Control Act (TSCA) requires the EPA to evaluate potential health and environmental risks of new chemicals using the best available science. The EPA's review determination for PMN P-16-0313, which was released in June, 2020, outlines the agency's risk evaluation and regulatory decision concerning the chemical, and may include regulatory controls or risk management measures if risks are identified, to address medical-conditions and health-and-wellness, and environmental-science concerns. However, without direct access to the EPA’s public docket or Federal Register notice for P-16-0313, the exact content of this determination cannot be confirmed from the provided information.

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