What Information Must be Submitted about New Chemical Substances?
This page describes the information required as part of a submission under the New Chemicals Review program.
- Required information
- Letter of support
- Chemical categories
- Avoid an incomplete PMN
- Notify EPA of newly identified data within 10 days of receipt
- Ask a specialist for help
- Chemical identity
- Production volume
- Environmental release
- Disposal practices
- 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 Agency with full identity information.
- All existing health and environmental data in the possession of the submitter, parent company, or affiliates, and
- A description of any existing data known to 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.
Specific chemical identity information is required for Bona Fide Intent to Manufacture (including Import) Notices, Premanufacture Notices, and other purposes under 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 amended regulation at 40 CFR section 720.45(a).
If confidential substances are involved and require a third party letter of support, 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.
– Submitters are encouraged to carefully review EPA regulations for new chemical submissions, including 40 CFR 720.45 and 40 CFR 720.50 which provide the information that must be included in the notice form. The accuracy and completeness of the notice form improves timeliness of the new chemical review by reducing or eliminating the need to request additional information and revisions of the risk assessment.
Cases are reviewed for administrative completeness and to ensure that all required technical information concerning chemical identity has been submitted, without errors. In striving to focus attention on timely review of complete and robust notices, EPA has issued regulations at 40 CFR 720.45 and 40 CFR 720.50 which describe the specific information that must be included in the notice form. EPA will determine if the notice is required, is incomplete and/or contains errors pursuant to regulations at 40 CFR 720.62 and 40 CFR 720.65. Failure to include the specific information required by the regulations may result in EPA declaring the submission incomplete and suspending its review. EPA may declare a submission incomplete at any time during the review period where the circumstances warrant doing so under these regulations.
- Guidance for Avoiding Incomplete PMNs
- Instruction Manual for Premanufacture Notification of New Chemical Substances explains the PMN reporting requirements in detail. The instruction manual information can also be found in the help sections of the e-PMN software.
- Chemistry Assistance Manual for Premanufacture Notification Submitters
If, during the new chemical review period, you receive or become aware of the existence of reasonably ascertainable test data or other information that adds to or makes more complete the determination of the potential unreasonable risk, you are obliged to send that information to the EPA within ten days of its receipt, but not later than five days before the end of the review period. If such information becomes available within five days of the end of the review period, you must inform your EPA contact by telephone.
- Additional toxicological information
- Details on manufacture, processing, use, and disposal
- Likely worker exposures and environmental releases
- Facts on innovations and improvements in product chemistry and safety practices.