Laws & Regulations

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0182

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0182, an alkyldioic acid.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0160-0161

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0160-0161, a 2-
Propenoic acid.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0158

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0158, a perylene bisimide.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-17-0006

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-17-0006, a modified version of saccharomyches cerevisiae.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-17-0001, 0002, 0003, 0004, and 0005

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-17-0001, 0002, 0003, 0004, and 0005, modified versions of saccharomyches cerevisiae.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-17-0007

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-17-0007, a modified version of saccharomyces cerevisiae that produces biofuel.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0108

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0108.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0236

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0236.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-20-0102

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-20-0102.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-20-0170 – P-20-0172

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-20-0170 – P-20-0172.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0107

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0107.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0379

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0379.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0387-0388

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0387-0388.

e-Premanufacture Notice (e-PMN) Webinars

These webinars explain how to use the electronic Premanufacture notice system (e-PMN) in the Central Data Exchange system (CDX).

Test Marketing Exemption (TME) for New Chemical Review under TSCA

Under section 5 of TSCA, EPA established an exemption for certain chemicals that are manufactured (including imported) for test marketing. You can learn more here about the requirements of this exemption, along with the review and submission process.

Guidance Documents and Sample Forms for Central Data Exchange (CDX) Registration and e-PMN Software (Thin Client)

For users submitting electronic notices through CDX, this page contains guidance documents and sample forms to help you, submit Premanufacture Notices (PMN), Bona Fide and biotechnology notices, among others.

Guidance for Avoiding Incomplete Premanufacture Notices or Bona Fides in the New Chemicals Program

This page contains documents to help you avoid having an incomplete Premanufacture notice or Bona Fide . The documents go over the chemical identity requirements and common errors that result in incompletes.

Memorandum of Understanding Between EPA and OSHA for Implementation of TSCA Section 5 and Sharing of Confidential Business Information

A Memorandum of Understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-20-0001

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-20-0001.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0132

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0132.