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What Information Must Be Submitted About New Chemical Substances?

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The Toxic Substances Control Act Hotline (tsca-hotline@epa.gov) can answer questions about the PMN process or filing a PMN form.
Call (202) 554-1404
Monday to Friday: 8:30 a.m. - 5:00 p.m. EST
FAX (202) 554-5603

PMN submissions require all available data on chemical identity, production volume, byproducts, 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 Agency with full identity information.

Submissions must be made on EPA Form 7710-25 using the new electronic PMN software. 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. 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.

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 determine potential risk. The Instruction Manual for Premanufacture Notification of New Chemical Substances (PDF) (51 pp, 721K, about PDF) explains the PMN reporting requirements in detail. The instruction manual information can also be found in the help sections of the e-PMN software. For further assistance, contact the Toxic Substances Control Act (TSCA) Hotline. A document is available on how to avoid incomplete PMNs.

A chemistry assistance manual has also been written by Agency personnel and is available in several formats:

Note to submitters: if, during the section 5 notice 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 address shown on the section 5 notice form 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 is described at 40 CFR Section 720.40(f), and includes additional toxicological information, details on manufacture, processing, use, and disposal; likely worker exposures and environmental releases; and facts on innovations and improvements in product chemistry and safety practices.

 


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