On November 25, 2008, the U.S. Environmental Protection Agency (EPA) released for public comment two background discussion documents, one on EPA's Toxic Substances Control Act (TSCA) Inventory Reset initiative and the other on EPA's proposed approach for the Inorganic High Production Volume (IHPV) Challenge Program. EPA is seeking comment on both topics, with comments due by January 23, 2009.

In the TSCA Inventory Reset Discussion Document, EPA reports that it is considering an approach that would allow persons to certify, online via a secure EPA website, that they have manufactured a chemical listed on the Inventory within a specified timeframe. EPA is considering a three-year period for the Inventory reset process. The certification process would exclude persons manufacturing or importing chemical substances that are not subject to TSCA Section 5(a) premanufacture notification (PMN) reporting requirements. This would exclude persons manufacturing or importing chemical substances that are not subject to PMN reporting requirements and Microbial Commercial Activity Notification (MCAN) reporting requirements. Under this approach, a "clean" reset Inventory would be developed, such that any chemical not on the reset Inventory would be subject to TSCA Section 5(a) PMN reporting requirements prior to manufacture.

EPA's proposed IHPV Challenge Program follows closely the HPV Challenge Program for organic chemicals that took place from 1998 to 2008. EPA believes the inclusion of an IHPV Challenge Program as part of the Chemical Assessment and Management Program (ChAMP) effort is an important step in characterizing the potential hazard of inorganic chemicals produced or imported into the U.S. at volumes of greater than one million pounds per year. According to the latest figures from the 2006 Inventory Update Rule (IUR), there are approximately 750 inorganic chemicals in commerce, 400 to 500 of which are HPV according to EPA estimates. Briefly, the program will consist of three phases:

• Phase 1: IHPV Challenge -- Develop, launch, and sign-up (now through December 2009).
• Phase 2: Receive/Review Data -- (~ 2010 – 2013).
• Phase 3: Assessing and Reducing Risks -- (~ 2013 – 2015).

Plainly, the TSCA Inventory reset initiative has enormous implications for any chemical manufacture and/or chemical importer, as well as their downstream customers and users. Any initiative that has as a possible consequence the need to obtain EPA approval for a chemical substance that is now distributed in commerce as a precondition for continued commercial use needs to be taken very seriously to avoid potential commercial disruption and legal enforcement jeopardy. EPA's approach is thoughtful and step-wise, but care should be taken to read EPA's proposed approach carefully and provide comment on it. The IHPV Challenge Program has critically important implications for the metals and inorganic chemical community. Readers are urged to review the Discussion Document, and comment on the approach, as appropriate.

Links

• Two background discussion documents