Laws & Regulations

Questions & Answers for the New Chemicals Program under the Toxic Substances Control Act (TSCA)

This Questions & Answers document for the New Chemicals Program is intended only to explain the requirements of TSCA section 5 and selected EPA regulations implementing section 5, and to provide useful information to persons subject to these requirements.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-16-0018

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-16-0018, a modified version of Saccharomyces cerevisiae.

Pre-publication copy of the Draft Algae Guidance

Pre-publication copy of the Draft Algae Guidance. An officail version will be made available on October 12, 2016.

Federal Register Notice: Significant New Use Rule on Certain Chemical Substances

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 57 chemical substances which were the subject of premanufacture notices (PMNs).

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-16-0403

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-16-0403, a Heteropolycyclic carboxylic acid.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-16-0024

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-16-0024, a modified version of Trichoderma reesei.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-16-0036 -- 0041

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-16-0036 -- J-16-0041, biofuel producing modified microorganisms, with chromosomally-borne modifications.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0237 and P-17-0238

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0237 and P-17-0238.

Chemical Categories Used to Review New Chemicals under TSCA

EPA groups Premanufacture Notice (PMN) chemicals with shared chemical and toxicological properties into categories. Establishing these categories has streamlined the process for Agency review of new chemical substances.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0328

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0328.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0119

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0119.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0169

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0169.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0272

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0272.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-19-0002

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-19-0002.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-18-0176

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-18-0176.

TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice (MCAN) J-19-0006-0008

This document describes EPA's Microbial Commercial Activity Notice (MCAN) review determination under amended TSCA for J-18-0006-0008.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-19-0148, P-19-0149, P-19-0150, P-19-0151

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-19-0148, P-19-0149, P-19-0150, P-19-0151.

Polymer Exemption Guidance Manual for premanufacture notices for new chemicals under the Toxic Substances Control Act (TSCA)

A technical manual to accompany, but not supersede the "Premanufacture Notification Exemptions; Revisions of Exemptions for Polymers; Final Rule" found at 40 CFR Part 723, (60) FR 16316-16336, published Wednesday, March 29, 1995.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-17-0246

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-17-0246, a polycarbonate polyol chemical.

TSCA Section 5(a)(3)(C) Determination for Premanufacture Number (PMN) P-16-0578

This document describes EPA's pre-manufacture notice review determination under amended TSCA for P-16-0578, an Alkenoic acid.