The Environmental Protection Agency (EPA) has issued a final rule (noticed via 82 FR 3641) that requires electronic reporting and recordkeeping by manufacturers and processors (including importers) of certain nanoscale chemical substances that are intended for commercial use. EPA derives this authority from the Toxic Substances Control Act (TSCA; 15 U.S.C. 2601 et seq.), specifically its authority to report and retain information on toxic substances (15 U.S.C. 2607, 40 CFR 704). The purpose of this new rule is to compile an inventory of chemical substances at the nanoscale level that are produced for commercial uses. The EPA does not presuppose that these substances pose any specific harm to human health or the environment. Instead, tracking these materials will inform the EPA if additional action under TSCA is necessary. The EPA states that the intention of the new ruling is not to define what is a nanomaterial, but rather to use important characteristics of nanomaterials to identify what qualifies a chemical substance or mixture for reporting.
This new rule applies to manufacturers and processors who are actively producing or importing “discrete” nanoscale chemical substances, as well as those who intend to produce or import such materials. A reportable material must first be considered a “chemical substance,” as previously defined by TSCA (15 U.S.C. 2602(2)), and also be:
- Solid at standard temperature and pressure (25 degrees Celsius and 1 atmospheric pressure); and
- Manufactured or processed:
- In a form where any particles are nanoscale size (1 – 100 nanometer (nm). These include nanoparticles that comprise agglomerates as well as aggregates; and
- To exhibit unique and novel properties because of its size. Nanoscale substances have different chemical, stability, and reactivity characteristics than substances at the bulk scale (sizes greater than 100 nm). Consequently, if the substance fits the specified size range, yet does not have a size-dependent property that differs from that at the bulk scale, then the substance is not classified, according to the new rule, as reportable nanoscale material.
To be defined as a “discrete” form of a previously-reportable chemical substance, the substance must differ from the previous substance in one or more of the following ways:
- Any one or combination of:
- A modification to at least one property of particular interest for health and human safety evaluation including: zeta potential, specific surface area, dispersion stability, or surface reactivity;
- A change in mean particle size greater than 7 times the standard deviation of the measured values (± 7 times the standard deviation); or
- A change to the manufacturing process that effects one or both of the following:
- A change in size; or
- A change in the substance’s properties as listed above;
- The new substance has a different shape; or
- The previously-reportable chemical substance is coated with another, different chemical substance or mixture.
Both engineered and naturally occurring discrete nanoscale materials are subject to this rule.
The rule exempts from reporting certain substances and actors.
Excluded substances include:
- By-products (unintended products or side-products that are also nanoscale), which are not intended to be made commercially available;
- Those materials that comprise less than 1% by weight of the article or compound with which the nanoscale substance is incorporated or surface-associated;
- Certain biological materials;
- Inorganic substances that separate completely in water to form ions that are smaller than 1 nm, because they do not exhibit new size-dependent properties; and
- Nanoscale chemical substances to be used as pesticides (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), or as a food, food additive, drug, cosmetic or device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)).
Excluded actors include:
- Research and development entities producing small quantities of discrete chemical substances;
- Entities that have previously submitted a notice under TSCA section 5 to EPA for a reportable chemical substance on or after January 1, 2005, except in the event that a new discrete form of the reportable nanoscale chemical substance has been or is intended to be manufactured or produced. The purpose of this specific exemption is to avoid duplicative reporting; and
- “Small” manufacturers or processors, defined as a company with sales of less than $11 million per year.
Reporting Timeline and Methods
Reporting entities should submit information, as required by previous regulation (40 CFR 704.11), using the EPA Central Data Exchange (CDX) portal, which was established originally under TSCA (40 CFR 704.20(e)).
If an entity is already generating a reportable material, then its production must be reported to EPA within one year of the final effective date of the rule. Companies intending to produce new reportable materials are required to file their report at least 135 days before beginning or within 30 days of having begun the manufacture or process.
EPA will make available the non-confidential information reported under the new rule through their database portal, which is located at ChemView; the agency does not intend to use information reported under this rule to publish an official separate database/inventory for nanomaterials. Entities may claim confidentiality through established EPA processes (40 CFR 704.7).