Companies that manufacture, import or process nanoscale materials would be subject to reporting requirements under a new proposed rule released today by EPA. EPA is proposing reporting obligations concerning use, exposure, and other factors under section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would apply to nanoscale chemical substances in the marketplace that have unique properties related to their size. The agency intends to use this information to determine if any further action under TSCA is needed.
Under the proposed rule [pre-publication version, PDF], companies would be required to report if they manufactured or processed a “discrete form” of a reportable nanoscale substance during the three years preceding the rule’s final effective date. EPA also proposes a continuing reporting requirement for companies intending to manufacture or process a discrete form of a reportable chemical substance after the rule’s final effective date. These manufacturers or processors would be required to report to EPA 135 days before the commencement of manufacturing or processing.
To the extent that it is known or reasonably ascertainable to the reporter, companies would have to submit the following information:
- Specific chemical identity;
- Material characteristics like morphology and surface modifications;
- Physical and chemical properties;
- Maximum weight percentage of impurities and byproducts;
- Production volumes;
- Use information;
- Detailed methods of manufacturing or processing;
- Exposure information, including estimates of numbers of individuals exposed in the workplace or in other scenarios;
- Release information, including estimates of amounts released;
- Risk management practices, such as protective equipment or hazard warnings; and
- Existing data concerning environmental and health effects.
Generally, nanoscale materials are chemical substances that have structures with dimensions “at the nanoscale,” meaning 1-100 nanometers (nm), and may have properties different from the same chemicals with structures at a larger scale, such as greater strength or lighter weight. The proposed rule would apply to substances that are:
- Solid at 25°C and atmospheric pressure; and are
- Manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100nm and exhibit unique and novel characteristics or properties because of their size.
The proposed reporting requirements apply to “discrete forms” of reportable chemical substances. In some cases, companies would be required to report separately for multiple nanoscale forms of the same chemical substance. The agency’s intent is to focus on “intentionally manufactured chemical substances at the nanoscale,” so unintended variations in particle sizes between production batches, for example, should not trigger § 8(a) reporting. EPA proposes to distinguish between these “discrete forms” based on a combination of the following three factors:
- a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale;
- a change in mean particle size of 10% or greater; and
- the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values.
Other examples of discrete forms include nanomaterials with different morphologies (spheres vs. rods) and nanoscale forms of the same material but coated with different substances.
The proposed rule applies to mixtures, including when nanomaterials are manufactured or processed “solely as a component of a mixture, encapsulated material, or composite.” However, if a nanomaterial is incorporated into a mixture, encapsulated material, or composite by the nanomaterial’s manufacturer, the incorporation step does not have to be separately reported.
EPA proposes to apply a modified version of the existing small manufacturer/processor exemption to § 8(a) requirements. Because nanoscale materials are produced at much lower production volumes, EPA seeks to eliminate the 100,000 pound volume threshold for exempted small manufacturers or processors. Instead, a company could qualify as a small manufacturer/processor if it has “sales of less than $4 million” per year.
The proposed rule also excludes certain substances, including nanoclays, DNA, RNA, proteins, and chemical substances “which dissociate completely in water to form ions that are smaller than 1 nanometer.” Certain reporting which would be duplicative is also excepted; e.g., companies that submitted information under EPA’s voluntary Nanoscale Materials Stewardship Program do not need to re-submit, nor do submitters of Premanufacture Notices (PMNs) filed since January 1, 2005.
Information would be collected electronically, using a modified version of the reporting form used by the voluntary NMSP initiative, and compatible with EPA’s existing Central Data Exchange (CDX) and Chemical Information Submission System (CISS), both used for other TSCA reporting. EPA is not proposing an inventory for nanoscale materials, although non-confidential information collected through this proposed rule would be published in ChemView.
In addition to the above proposed reporting requirements, EPA is seeking input on various related issues, including “the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule.”
EPA is accepting comments on the proposed rule for 90 days following its publication in the Federal Register. The agency also anticipates holding a public meeting during the comment period.