EPA Promulgates New Use Rules for Two Nanoparticles

The U.S. Environmental Protection Agency recently published a direct final rule promulgating significant new use rules under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for several chemical substances, including two nanoparticles. These substances are now subject to premanufacture notices (PMNs) and include:

  • Siloxane modified silica nanoparticles (generic)--As described in the PMN, the generic use of the substance will be as an additive, and dermal and inhalation exposures are not expected. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. However, EPA has determined that use without impervious gloves or a NIOSH-approved respirator with an assigned protection factor (APF) of at least 10; the manufacture, process, or use of the nanoparticle as a powder; or the use of the nanoparticle other than as described in the PMN may cause serious health effects. The nanoparticle will be listed at 40 CFR 721.10119.
  • Siloxane modified alumina nanoparticles (generic)--As described in the PMN, the generic use of the substance will be as an additive, and worker dermal exposure is not expected, but worker inhalation exposure will be minimal due to adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. However, EPA has determined the use without impervious gloves or a NIOSH-approved respirator with an APF of at least 10; the manufacture, process, or use of the nanoparticle as a powder; or the use of the nanoparticle other than as described in the PMN may cause serious health effects. The nanoparticle will be listed at 40 CFR 721.10120.

According to the rule, people who intend to manufacture, import, or process any of the regulated chemical substances for an activity that is designated as a significant new use by this rule must notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. See the rulemaking at http://edocket.access.gpo.gov/2008/pdf/E8-26409.pdf.

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