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What information must be submitted about new chemical substances?

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 enable the Agency to have full identity information.

Submissions must be made on EPA Form 7710-25 - Part 1 (PDF) (7 pp, 620K, about PDF) and Part 2 (PDF) (6 pp, 526K, about PDF). A graphic of the form (PDF) (15 pp, 543K, about PDF), with annotations, has been developed for its internal use by the 3M Company, and a copy is available here. EPA also 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 chemicals of commonly submitted types is identified in the Chemical Categories document. All of this information is considered by Agency risk assessors to determine whether the likely risk is unreasonable.

The New Chemicals Program can require submission of any additional data, including development of data through testing, when the information included with the PMN, coupled with that available to its risk reviewers from internal archivesl is not adequate to clarify for them whether the likely risk is unreasonable. The Instruction Manual for Premanufacture Notification of New Chemical Substances (PDF) (51 pp, 721K, about PDF) explains all reporting requirements. When you request a PMN form, the instruction manual is included. Both are available from 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, it is available in several forms:

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, which adds to or makes more complete the determination of the potential unreasonableness of 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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