On 12 January 2016, the United States Environmental Protection Agency (EPA) promulgated a final rule on 'Reporting and Recordkeeping Requirements' for chemical substances when manufactured or processes as nanoscale materials.
Under Section 8(a) of the Toxic Substances Control Act (TSCA), 'this rule involves one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials before those new forms are manufactured or processed'.
Reportable substances are defined in this rule as follows:
'chemical substances, as defined in section 3 of TSCA, that are solids at 25 °C and standard atmospheric 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 (nm) in at least one dimension; and that are manufactured or processed to exhibit one or more unique and novel properties. This rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm.'
Small manufacturers and processors (with sales under $11 million per year), R&D, and substances already reported to EPA are excluded from reporting.
For this one-time regsitration, EPA requires information on 'specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing and processing, exposure and release information, and existing information concerning environmental and health effect' of the registered nanoscale materials.
The rule will be effective on 12 May 2017, 120 days from its publication on the Federal Register. It requires people who manufacture or process nanoscale materials during the three years before this date to report to EPA via the Agency's electronic portal (EPA CDX) one year after. Manufacturers and processors must report to EPA 'at least 135 days before manufacture or processing of that discrete form'.
Please follow this link for the full Final EPA rule 82 FR 3641 'Reporting and Recordkeeping Requirements' for chemical substances when manufactured or processes as nanoscale materials.
Learn more about the latest TSCA developments at our 30 March 2017 NIA Symposium in Brussels and in an upcoming NIA Members webinar.