By Lynn L. Bergeson, Small Times guest contributor

August 10, 2007 — The EPA’s recently released paper, TSCA Inventory Status of Nanoscale Substances — General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of “chemical substance” are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, “any organic or inorganic substance of a particular molecular identity.”

If a nanoscale material is listed on the TSCA Inventory it is considered “existing” it is not subject to new chemical reporting requirements. If it is not Inventory listed, EPA considers the substance “new” and, unless a PMN exemption applies, the manufacturer must submit a PMN to EPA at least 90 days before commencing commercial manufacture or import.

The cost and timing of satisfying PMN requirements are difficult to predict and inject uncertainty into an already uncertain business environment. EPA’s guidance is a must-read for nanoscale material manufacturers, as it can assist in determining how to proceed with newly developed materials.

EPA seeks comment on the guidance by September 10, 2007, and I encourage all stakeholders to contribute to this critically important discussion. Comments on the TSCA Inventory Status of Nanoscale Substances — General Approach must be identified by the docket ID number that EPA has established for it: EPA-HQ-OPPT-2004-0122. You can submit comments online or by mail: Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

Lynn L. Bergeson is Managing Director of Bergeson & Campbell, P.C., a law firm focused on specialty chemical product approval and regulation, health and safety law, chemical product litigation, and associated business issues.