(a) A ballast water management system (BWMS) may not use an active substance or preparation that is a pesticide unless the sale and distribution of such pesticide is authorized under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use in ballast water treatment prior to submission to the Coast Guard for approval of the BWMS. This requirement does not apply to the use of active substances or preparations generated solely by the use of a device (as defined under FIFRA) onboard the same vessel as the ballast water to be treated.

(b) The manufacturer of a BWMS that uses an active substance or preparation that is not a pesticide, or that uses a pesticide that is generated solely by the use of a device (as defined under FIFRA) onboard the same vessel as the ballast water to be treated, must prepare an assessment demonstrating the effectiveness of the BWMS for its intended use, appropriate dosages over all applicable temperatures, hazards of the BWMS, and means for protection of the environment, and public health. This assessment must accompany the application package submitted to the Coast Guard.