On April 6, 2015, the US Environmental Protection Agency (EPA) proposed a new rule detailing one-time reporting and record-keeping requirements for manufacturers and processors of nanoscale materials (NMs) under Section 8(a) of the Toxic Substances Control Act (TSCA).
The long-awaited proposed rule comes over 7 years after EPA initiated a one-year pilot program for voluntary reporting. The proposed rule applies to anyone who manufactures, imports, or processes a “reportable chemical substance.” A reportable substance is defined as one that is solid at 25°C under atmospheric pressure, manufactured or processed so that its primary particles, aggregates, or agglomerates are 1-100 nm in size, giving them unique and novel characteristics or properties. Reporting is also required for “discrete forms” of these substances, if:
- the process has been changed to alter the substances’ size, properties, or both;
- mean particle size has been altered by 10% or more;
- the measured change in zeta potential, specific surface area, dispersion stability, or surface reactivity exceeds 7 times the standard deviation of the measured values.
Some substances are excluded from reporting requirements, notably any for which Premanufacture Notices (PMNs) covering their discrete forms were submitted on or after January 1, 2005. Also excluded are certain biological materials (e.g. DNA, RNA and proteins); substances that completely dissolve in water; nanoclays; zinc oxide; and NMs manufactured as part of a film. For substances to which the rule applies, one-time electronic reporting is required 6 months after the final rule’s effective date for anyone currently working with NMs, and 135 days before manufacturing or processing begins for anyone intending to work with NMs.
Information required for each discrete form of a reportable chemical substance would include its specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and information on environmental and human health effects. This NM-specific information would help EPA evaluate whether further action is necessary to adequately assess risks to human health and the environment.
The EPA will hold a public meeting to discuss the proposed rule on June 11 and is accepting public comment through July 6, 2015.
Public meeting details are here.
Public comments may be submitted here.
Full text of the proposed rule is available here.