Monday, January 25, 2010

EPA Plans new TSCA Rules to Regulate Nanomaterials

In continuing their seemingly new-found enthusiasm for existing authority under the current Toxic Substances Control Act (TSCA), the USEPA is planning to issue a series of rules to better regulate nanomaterials. These materials are made small - very small - compared to other materials with the same chemical composition, and there is concern that they may have different risk profiles than their larger counterparts.

EPA announced in December 2009 as part of its "Action Initiation List" that it is developing a SNUR, shorthand for a "significant new use rule." SNURs require manufacturers of existing chemicals intended for significant new uses to notify EPA similar to the way they would if it had been a new chemical. The argument is that since nanoscale materials may have very different properties than the existing chemical form that they may result in very different risk. Not a big stretch given that most nanomaterials are designed specifically to impart different properties to the uses in which they are intended.

Another rule (under Section 8 of TSCA) was recently announced by EPA that would require additional reporting of such things as production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. Taken together with the SNUR, these rules would give EPA substantial ability to better regulate nanomaterials.

So why is this a big deal? A couple of reasons come immediately to mind. One is that it significantly changes the Bush administration finding in 2008 that two vastly different forms of the same chemical would be considered "to be the same substance because they have the same molecular identity," despite acknowledging that "certain physical and/or chemical properties" may differ. Given that the physical and chemical properties can strongly influence the hazard of the chemical, the old designation would seem to be hard to justify.

Another reason it is a big deal is that this means that nanomaterials will be given much greater scrutiny than in the past. Which means most new nanoscale materials will have to go through the slightly more rigorous process for review of new chemicals than they would have if assumed to be existing chemicals (which essentially get no review).

Needless to say, not everyone is happy with the prospects of these new rules. But EPA has felt hamstrung in the past and seems under the current Administration to be more willing to aggressively use their current authority. These individual actions will no doubt be considered by Congress as they prepare the updated Kid Safe Chemical Act.

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