July 1st, 2015

US EPA has proposed a new rule requiring reporting and recordkeeping for certain manufactured and processed nanomaterials under Section 8(a) of the Toxic Substances Control Act (TSCA). "EPA's proposed rule requiring recordkeeping and reporting rules for nanomaterials is premature the absence of (1) recommended characterizations;(2) recommended test guidelines (or standards) and guidance; and (3) recommended reference materials," stated Ryman-Rasmussen in public comments submitted to EPA. Comments by Ryman-Rasmussen, who is a former EPA toxicologist with both regulatory and research experience on the toxicology of nanomaterials, further explained that "These are needed in order to facilitate industry compliance and to ensure that EPA receives data of sufficient quality for risk assessment." The public comment period for the proposed rule is open until July 6, 2015 (although requests for a 30-day extension have been submitted). The text of the proposed rule, as well as submitted comments, can be found on docket EPA-HQ-OPPT-2010-0572-0001 at www.regulations.gov.

US EPA has proposed a new rule requiring reporting and recordkeeping for certain manufactured and processed nanomaterials under Section 8(a) of the Toxic Substances Control Act (TSCA).
"Nanotechnology is powerful because nanomaterials can go places larger-sized materials can't go and do things larger-sized materials can't do. This is why some people are concerned about potential human health and environmental effects," explains Jessica Ryman-Rasmussen, PhD, DABT and Director and Principal at SD-based Atlas Regulatory Toxicology, Inc.
Importantly, EPA was clear that "The proposed rule is not intended to indicate restrictions or conclusions about the risks of chemical substances manufactured at the nanoscale in general. Rather, the requirements would facilitate EPA'sevaluation [sic] of the materials and its determination of whether any further action under TSCA, including additional information collection, is needed."
Consistent with previous actions, EPA is not providing a definition of nanomaterials, but is instead specifying that "This proposed rule would apply to chemical substances that are solids at 25 ºC and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size."
Characterization of the physicochemical properties of nanomaterials is important, both for nanomaterial identification and for interpreting information regarding toxicity. EPA does not specify required characterizations, recommended test methods or standards, and recommended reference materials in the proposed rule.
"EPA's proposed rule requiring recordkeeping and reporting rules for nanomaterials is premature the absence of (1) recommended characterizations;(2) recommended test guidelines (or standards) and guidance; and (3) recommended reference materials," stated Ryman-Rasmussen in public comments submitted to EPA. Comments by Ryman-Rasmussen, who is a former EPA toxicologist with both regulatory and research experience on the toxicology of nanomaterials, further explained that "These are needed in order to facilitate industry compliance and to ensure that EPA receives data of sufficient quality for risk assessment."