New Chemicals Program Letters of Support

Adequate chemical identity information for Section 5 notices includes ensuring that EPA is notified of any confidential identity information about reactants used in manufacture. Information which has been withheld from the submitter by its supplier can be submitted directly to EPA by its domestic or foreign supplier or manufacturer. As an example, a manufacturer may use a reactant in its synthesis which is known to it only by a trade name.

A supplier, domestic or foreign, can submit its letter of support, confidential from the manufacturer/importer, describing the substances not found on the non-confidential Inventory (the supplier will already have searched the non-confidential Inventory) and which comprise or are used to manufacture the substance to be manufactured or imported. The supplier will give adequate chemical identification information, as complete as is known, as specified in the amended regulation at Section 720.45(a), for the substances confidential from the submitter.

If there is any such material, the submitter will need to pay attention to the 30-day requirement for supporting notices for bona fide submissions found at 40 CFR Section 720.25 (b)(viii)(B)(3)(i), and to the non-commencement of the 90-day review period for PMNs until all supporting material has been received as described at 40 CFR Section 720.40(e)(3), and to ensure that all the supporting material arrives at EPA in a timely manner). Use of imported branded materials of confidential composition requires care on the part of a manufacturer. The manufacturer should make an agreement with its supplier to be informed of any changes in composition which can change chemical identity.

New Chemicals Program Letters of Support

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