The U.S. Environmental Protection Agency (EPA) has issued guidance to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA). The guidance, titled Points to Consider When Preparing TSCA New Chemical Notifications, promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.
“Through early engagement with industry and by being clear and specific about what information we require from them in their new chemical submission, we increase manufacturers’ certainty, improve submissions, and get new, safer chemicals on the market faster and more efficiently,” said EPA Administrator Scott Pruitt.
TSCA requires anyone who plans to manufacture (including import) a new chemical substance to provide EPA with notice before initiating the activity. This notice is known as a premanufacture notice (PMN). The guidance provides the general public, including new chemical submitters, with important information on:
- General guidance relating to new chemical notices;
- Preparation of pre-manufacture notices (PMNs), Significant New Use Notices (SNUNs), and exemption notices;
- EPA scientific approaches used in conducting PMN assessments; and
- Best practices.
EPA has incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document. EPA expects that use of this guidance will result in more robust submissions to the Agency.
EPA is also encouraging companies to contact EPA’s new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their PMN. The pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand the Agency’s approach to reviewing new chemicals for potential risks early in the process.