Pre-Manufacture Notification Decision for Premanufacture Number (PMN) P-16-0512 under TSCA Section 5(a)(3)(C)

Pre-Manufacture Notification Decision for Premanufacture Number (PMN) P-16-0512 under TSCA Section 5(a)(3)(C)

The Environmental Protection Agency (EPA) has released the review determination for Premanufacture Number (PMN) P-16-0512, a chemical substance or mixture, under the amended Toxic Substances Control Act (TSCA). The document, dated June 2020, is publicly available and does not contain Confidential Business Information (CBI), making it accessible to the public.

The review determination for PMN P-16-0512 was made under TSCA Section 5(a)(3)(C), which requires the EPA to evaluate the potential risks associated with new chemical substances before they enter commerce. Under this section, the EPA must determine whether the chemical subject to a PMN presents an unreasonable risk or may be otherwise subject to regulation before manufacturing can start.

The EPA's review process for PMN P-16-0512 involves a comprehensive assessment of hazard, exposure, and risk. The agency may impose consent orders or significant new use rules (SNURs) as needed to manage the risks associated with the new chemical.

This review determination is part of the EPA's broader mandate to manage new chemical risks pre-market under the TSCA amendments. The amended TSCA establishes a framework for the EPA to review all new chemical submissions, make affirmative risk determinations, and only permit manufacture after concluding the review period safely. The 90-day review period applies, and the decision can include conditions on the substance’s use or processing to mitigate risk.

However, no specific indication for PMN P-16-0512’s final determination or any unique EPA order is included in the search results. For exact determination details on PMN P-16-0512, the EPA’s official database or Federal Register notices must be consulted.

The review determination for PMN P-16-0512 is a PDF file with a size of 177.64 KB. The document is publicly available and can be accessed via the EPA's website.

1. The Environmental Protection Agency's review determination for PMN P-16-0512, a chemical substance or mixture, is part of the agency's broader mandate in health-and-wellness and environmental-science, as it aims to manage new chemical risks pre-market under the TSCA amendments.
2. The comprehensive assessment of hazard, exposure, and risk involved in the EPA's review process for PMN P-16-0512 is significant in the field of science, as it may result in the imposition of consent orders or significant new use rules (SNURs) to manage the risks associated with the new chemical.

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