TSCA Advisory 02 - VI

On December 11, 2002, EPA announced the initiation of a voluntary pilot program that will cut the traditional 90-day TSCA premanufacture notice ("PMN") period in half for certain chemical companies. (67 Fed. Reg. 76,282) Under section 5(a) of TSCA, companies are required to notify EPA at least 90 days before manufacturing or importing a new chemical substance for non-exempt purposes. The pilot program will allow a qualifying company to begin manufacturing a new chemical substance under the test marketing exemption ("TME") after only forty-five days and continue to manufacture the substance for commercial purposes after ninety days.

EPA historically has rejected simultaneous submission of exemption notices and PMNs for the same substance, and has allowed TME applications in combination with PMNs only as long as "the submitter's description clearly distinguishes the test marketing activity from full-scale commercial production or research and development." Under the pilot program, a manufacturer may qualify to make simultaneous submissions by demonstrating that the chemical substance at issue will not cause unreasonable risk to health or the environment, using EPA's "P2 Framework" for modeling hazard and exposure, or another scientifically acceptable approach for chemical risk screening. In addition, companies with extensive and successful PMN experience may qualify. Through experience with this pilot program, EPA may develop an exemption from the PMN requirements to promote the development of low-risk, low-hazard chemicals that would supplement the low volume exemption ("LVE"), low release and low exposure exemption ("LoREX"), polymer exemption, and test marketing exemption already in existence.

Comments on the pilot program are due to EPA on or before June 9, 2003. This is an opportunity for companies that presently are subject to PMN requirements to propose suggestions for reducing the reporting burden or expanding the qualifying parameters of the pilot program. If you need further information concerning this development, or require assistance with preparing comments regarding the proposal, please contact one of the TSCA professionals below.

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