(Resisting the urge to make an obscure Mork and Mindy reference – or an even more obscure mention of Fantastic Voyage…)
EPA has issued guidance on complying with the new Nanotechnology Reporting and Recordkeeping Rule, published in January with an effective date that has been extended to August 14, 2017. The rule establishes one-time reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale (i.e., materials that are solids at standard temperature and pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers – that’s one to one hundred billionths of a meter – in at least one dimension) for the purpose of demonstrating one or more unique, size-dependent properties that would not be present in larger materials. Reporting for existing nanomaterials that have been manufactured or processed in the three years prior to the effective date will be due by August 14, 2018.
Specifically, the rule requires manufacturers (defined by statute to include importers) or processors of these chemical substances to electronically report to EPA certain information, which includes where known or reasonably ascertainable the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.
Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of this rule must report to EPA one year after the final effective date of the rule. In addition, a standing one-time reporting requirement applies for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form except where the person has not formed an intent to manufacture or process a discrete form of a reportable chemical substance 135 days before such manufacturing or processing, in which case the information must be filed within 30 days of the formation of such an intent.