On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. Here is a summary.
The EPA proposed a one-time reporting of certain information: specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data. The EPA modified an information reporting form developed for the Nanoscale Materials Stewardship Program (NMSP) for these purposes. Any person required to report under the proposed rule would supply the information identified in the form to the extent it is “known to or reasonably ascertainable” by them.
Manufacturers and processors of multiple nanoscale forms of the same chemical substance would in some cases need to report separately for each form of the reportable substance. The EPA proposed to distinguish the forms based on three factors: a change in process to affect a change in size or a change in properties of the chemical substances manufactured at the nanoscale; a change in mean particle size of 10% or greater; and a measured change in at least one of the following properties — zeta potential, specific surface area, dispersion stability, or surface reactivity — that exceeds seven times the standard deviation of the measured values.
The proposed rule would apply to chemical substances manufactured or processed in a nanoscale form “solely as a component of a mixture, encapsulated material, or composite.” Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials, or composites by that manufacturer would not require separate reporting for their incorporation.
Certain exemptions apply. Not included are any food, food additive, drug, cosmetic, medical device, pesticide or other excluded materials. Also excluded are certain biological materials (e.g., DNA, RNA and proteins). The EPA also proposes to exclude from the reporting requirements nanoclays, zinc oxide and chemical substances manufactured at the nanoscale as part of a film on a surface. Other exemptions under TSCA Section 8(a) also apply.
The EPA proposes an alternative to the existing small manufacturers exemption. The proposed rule would define a small manufacturer or processor as any company with sales of less than $4 million, as the 100,000-lb threshold in the existing exemption “did not contemplate typical production volumes for chemical substances manufactured at the nanoscale.”
A person who submitted a TSCA chemical notice under Section 5 on or after January 1, 2005, would not be required to report regarding the same substance under this proposed TSCA Section 8(a) rule, except where the person manufactured or processed a new discrete form of the reportable chemical substance. Any person who reported under the NMSP part or all of the information that would be required under the proposed rule would not need to report that information again.
The EPA proposes that 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 the rule would report to the EPA six months after the final effective date of the rule. The EPA also proposes a continuing requirement that anyone who intends to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule would report to the EPA at least 135 days before commencement of manufacture or processing.
The EPA has stated for years that it needs information on nanoscale versions of existing chemical substances in commerce to ensure it can discharge its duties under TSCA. The proposal will almost certainly elicit a broad array of diverse comments from stakeholders; the EPA can expect robust participation in a planned public meeting. On the whole, the proposal is a thoughtful and useful step in gathering much-needed information on existing chemical substances manufactured at the nanoscale. Comments are due by July 6, 2015.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).