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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.

Important Notice on branded materials of confidential composition.

 


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