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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

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

The e-PMN software will prompt submitters for the specific information required. In general, PMN submissions require all available data on:
  • Chemical identity
  • Production volume
  • Byproducts
  • Use
  • 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.

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, 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.

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Letter of support

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.

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Chemical categories

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

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Avoid an incomplete PMN 

An incomplete PMN can delay EPA's review, so it is important to avoid submitting an incomplete notice. EPA found that most of the premanufacture notices declared incomplete by EPA were due to chemical identity/nomenclature errors. Here are some resources to assist in filling out a PMN to avoid an incomplete:
 

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Notify EPA of newly identified data within ten days of receipt

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.

This obligation includes:
  • 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.
 

To submit this information, use EPA Form 7710-25 using the new electronic PMN (e-PMN) software.

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