• If confidential substances are involved and require a third-party letter of support, then a bona fide notice or PMN submitter must keep in mind that all supporting material must be received by EPA for a bona fide notice or PMN to be considered complete.
• Information frequently requested by the New Chemicals Program for groups of chemicals with common characteristics is identified in the New Chemical Categories document.

The e-PMN software will prompt submitters for the specific information required. In general, premanufacture notice (PMN) submissions require all available data on:

• Chemical identity, structure, and formula;
• Process diagram and description;
• Production volume;
• By-products and impurities;
• Intended use;
• Environmental release;
• Disposal practices; and
• Human exposure.

If the identity of some reactants for substance synthesis, or of the substance itself, is unknown to the manufacturer, a letter of support can be used to provide the Environmental Protection Agency (EPA) with full identity information.

EPA requires that the following information be submitted with the PMN:

• All existing health and environmental data in the possession of the submitter, parent company, or affiliates;
• A description of any existing data known to or reasonably ascertainable by the submitter; and
• Any safety data sheet (SDS) that is already developed for the new chemical substance, including draft SDSs (this requirement would not require submitters to develop an SDS but to submit an already-developed SDS to the extent the SDS is known or reasonably ascertainable by the submitter).

The New Chemicals Program can require submission of any additional data, including development of new data through testing, when the information included with the PMN, coupled with that available to EPA risk reviewers from internal archives, is not adequate to permit a reasoned evaluation of the health and environmental effects of a chemical substance.

Letter of support

Specific chemical identity information is required for Bona Fide Intent to Manufacture (including Import) Notices, PMNs, and other purposes under the Toxic Substances Control Act (TSCA). EPA must be notified of any confidential chemical identity information (e.g., a reactant only known by a trade name is used in the manufacture of a chemical substance that is the subject of a bona fide notice or PMN).

Information that has been withheld from the submitter by a third party should be submitted directly to EPA by that third party (e.g., usually a domestic or foreign supplier or manufacturer). In its letter of support, the third party must provide chemical identity information for the confidential substance as specified in the regulation at 40 CFR 720.45(a).

If confidential substances are involved and require a third-party letter of support, then a bona fide notice or PMN submitter must keep in mind that all supporting material must be received by EPA for a bona fide notice or PMN to be considered complete. A submitter should also have an agreement with its supplier to ensure being informed of any changes in composition that can change the chemical identity of the confidential substance.

Manufacturers and importers whose reportable substances are manufactured with branded materials that have confidential components should take steps to be informed in a timely manner if the branded materials change in composition. EPA does not use brand names in listing substances on the TSCA Inventory, in part because branded materials formulations can change and in part because the TSCA Inventory identifies and lists specific chemical substances and not formulations.

New chemical categories

Information frequently requested by the New Chemicals Program for groups of chemicals with common characteristics is identified in the New Chemical Categories document. All of this information is considered by EPA risk assessors during the notice review process.