• Failure to include the specific, required information may result in EPA declaring the PMN submission incomplete and suspending its review.
• If new information becomes available within five days of the end of the review period, the submitter must inform the EPA contact by telephone.

Avoid an incomplete premanufacture notice (PMN)

Submitters are encouraged to carefully review Environmental Protection Agency (EPA) regulations for new chemical submissions, including 40 CFR 720.45 and 720.50, which provide the information that must be included in the notice form. The accuracy and completeness of the notice form improves timeliness of the new chemical review by reducing or eliminating the need to request additional information and revisions of the risk assessment.

Cases are reviewed for administrative completeness and to ensure that all required technical information concerning chemical identity has been submitted, without errors. In striving to focus attention on timely review of complete and robust notices, EPA has issued regulations at 40 CFR 720.45 and 720.50, which describe the specific information that must be included in the notice form.

EPA will determine if the notice is required, is incomplete and/or contains errors pursuant to regulations at 40 CFR 720.62 and 40 CFR 720.65. Failure to include the specific information required by the regulations may result in EPA declaring the submission incomplete and suspending its review. EPA may declare a submission incomplete at any time during the review period where the circumstances warrant doing so under these regulations. EPA’s Instruction Manual for Premanufacture Notification of New Chemical Substances explains the PMN reporting requirements in detail. The instruction manual information can also be found in the help sections of the e-PMN software.

Notify EPA of newly identified data within ten days of receipt

If, during the new chemical review period, a submitter receives or becomes 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, the submitter is obliged to send that information to 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, the submitter must inform the EPA contact by telephone. This obligation 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.

This requirement is described at 40 CFR 720.40(f). To submit this information, use EPA Form 7710-25 using the electronic PMN (e-PMN) software.