Developments on nanomaterial governance in US gather pace

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Courtesy of Bergeson & Campbell, P.C.

Congress is considering legislation to amend the Toxic Substances Control Act (TSCA), the core federal chemical management law ( CW 15 April 2010 ). Under the current interpretation of the US Environmental Protection Agency (EPA), a chemical sharing the same molecular identity as a chemical listed on the TSCA inventory is considered an existing chemical (and thus no premanufacture notice is required), regardless of whether the chemical possesses novel properties that influence its risk profile. Some believe this interpretation has contributed to the current debate questioning TSCA’s core adequacy.

While never mentioning “nanotechnology,” a bill (S 3209) introduced in the Senate in April contains provisions pertinent to variants of chemicals with “special substance characteristics”, language widely believed to be a surrogate for nanoscale chemical substances. The bill authorises the agency to evaluate and compel data on new or special uses of existing chemicals “separate from any use of the chemical substance that does not exhibit such special substance characteristics” or on new chemical substances exhibiting special substantive characteristics.

The House of Representatives is also expected soon to introduce TSCA reform legislation. In a discussion draft of House legislation circulated in April, “substance characteristic” is defined “with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance,” and whose variation may bear on toxicological properties, including chemical structure and composition, size or size distribution, shape, surface structure, reactivity, and other characteristics and properties that may bear on toxicological properties. It is unclear if any House bill will contain similar language. Even if it does, it is unclear whether more mature TSCA reform proposals will reflect this approach essentially to regulate nanoscale substances as new chemicals.

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