Assistance with pre-manufacture notice (PMN) submission, as a Support Registrant, for compliance with the US Toxic Substances Control Act (TSCA)

Client

An international industrial chemicals manufacturer and importer.

Background

If industry intends to manufacture or import “new” chemicals (those not already present on the TSCA Inventory, and not excluded from notification) within or into the United States, they are required to submit a PMN form to the US Environmental Protection Agency (EPA). The PMN submission provides the US EPA with the relevant key studies on the chemical’s (eco)toxicological, physical-chemical and environmental fate properties , as well as information on exposure and use, to enable the Agency to assess the risks to human health and the environment.

Project Goals

Assist the client in their urgent PMN submissions to the US EPA.

Approach

Bibra assessed the relevant available data on the substances of interest, identifying key studies and concisely describing their findings (with associated reliability score), and drafting data waivers where appropriate. Corresponding full reports and publications were gathered, carefully organised and attached to the main and supporting PMN files as appropriate. Our toxicologists also provided assistance with the completion of the Physical & Chemical Properties Worksheet, producing a clear summary of the key physical-chemical properties of the  substances of interest, and peer-reviewed the included company data. As a delegated Support Registrant, bibra scientists created and submitted support PMN files containing hundreds of study reports and publications identified as key in regards to (eco)toxicological, physical-chemical and environmental fate endpoints for each substance.

Project Outcome

Bibra successfully provided the client with the completed main PMN file and subsequently submitted the supporting PMN files directly via the eTSCA software, providing the relevant data on the substances of interest to the US EPA.

Project Leaders

Richard Young

Beth O'Connell



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