EPA promulgates further Significant New Use Rules (SNUR) on nanomaterials

EPA is issuing these SNUR for specific chemical substances which have been subject to the premanufacture notice process (PMN) under TSCA. PMN applies to new chemical substances only and allows EPA to perform a premanufacture review of the concerning substance.

The issued SNUR require persons who intend to manufacture, import, or process any of these 23 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNUR as a significant new use.The required notification will provide EPA with the opportunity to evaluate the intended use and, if appropriate, to regulate the proposed use before it occurs.

Among the concerning chemical substances are many non-nanomaterials, but also different modifications of single-walled and multi-walled carbon nanotubes, carbon black, and (mixed) metal oxide containing film coating additives. In the cases subject to SNUR where nanomaterials can be expected to be involved, EPA states to have concerns regarding potential lung effects of the PMN substance. Therefore, EPA has determined in the SNUR that a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline), in some cases including a with a post-observation period of up to 3 months, would help characterize the human health effects of the PMN substance.

Four of the 23 chemical substances are already subject to TSCA section 5(e) consent orders issued by EPA. Consent orders are negotiated between EPA and a manufacturer of a PMN substance and place specific requirements on the manufacturer (usually involving delivery of test sampes, conducting defined toxicity tests or applying additional protective measures). E.g., in the case of multi-walled carbon nanotubes, the consent order requires use of a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator. To make such consent orders binding to any manufacturer of the corresponding substance, however, EPA usually promulgates a SNUR.

EPA is promulgating these SNURs using direct final procedures. This rule is effective August 24, 2009 without further notice, unless EPA receives written adverse or critical comments.

EPA Federal Register Notice of June 24, 2009 (Volume 74, Number 120)