The U.S. Environmental Protection Agency’s (EPA) new rule establishing reporting and recordkeeping requirements for nanomaterials is effective. Today we will look at the reporting requirements and who must report. Tomorrow we will review the exemptions and the compliance timeline for the nanomaterials reporting rule.
Background: What Are Nanoscale Materials?
Nanomaterials are chemical substances that have structures with dimensions at the nanoscale—approximately 1–100 nanometers. To get an idea of their size, a human hair is approximately 80,000–100,000 nanometers wide.
The thinking is that nanomaterials may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These different properties give nanoscale materials a range of potentially beneficial public and commercial applications. For example, they could improve products such as anticancer therapies, TVs, vehicles, batteries, and solar panels.
However, the special properties that make nanoscale materials of potentially great benefit can also present new challenges for risk assessment and decision making. Their small size may allow them to pass through cell membranes or the blood-brain barrier, possibly resulting in unintended effects.
What’s Reportable?
Reportable chemical substances are those that are solids at 25ºC 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 to 100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size. This doesn’t mean that every chemical substance that contains particles in the size range of 1–100 nm must be reported. The idea of unique and novel characteristics means that in order to be reportable, the substance must have a size-dependent property different from properties at sizes greater than 100 nm, and those properties are the reason the substance is manufactured or processed in that form or size. So, the requirements do not apply to aggregates or agglomerates greater than 100 nm even if they contain primary particles (i.e., particles that form during manufacture before aggregation or agglomerization) less than 100 nm.
Note: It is important to be aware that the reporting requirements apply to discrete forms of the reportable chemical substances. The idea of a discrete form of the substance is also important when considering the exemptions from the nano reporting requirements. A discrete form of the substance has one or more of three characteristics:
- The change in the reportable substance is due to a change in the process that effects a change in size and/or a change in one or more properties (i.e., Zeta potential [the electrostatic potential near the particle surface], specific surface area, dispersion stability, or surface reactivity); and there is a size variation greater than 7 times the standard deviation of the mean particle size;
- The reportable substance has a different morphology, i.e., any change in shape (e.g., sphere, wire, needle, cage, sheet); and
- The reportable substance that is coated with another chemical substance or mixture at the end of the manufacturing or processing has a coating that consists of a different chemical substance or mixture.
What About Mixtures?
Although you are not required to report mixtures, you must report the components of any mixture that contains a reportable substance. Therefore, you have to evaluate the requirements for each chemical substance in the mixture. In addition, if a manufacturer sells a mixture to multiple processors, each processor is also required to report.
Who Must Report?
You must report if you manufactured or processed a discrete form of a reportable quantity of nanomaterials during the 3 years before the effective date of the rule (i.e., August 14, 2017).
Although it is really up to you to determine if this new rule applies to your operations, the EPA has provided a list of sectors to which the reporting requirements may apply. The list includes:
- Chemical manufacturers and processors;
- Synthetic dye and pigment manufacturers;
- Other basic inorganic chemical manufacturers (e.g., manufacturers of alkalies, sulfuric acid; hydrochloric acid; chlorine; carbon black; carbides);
- Rolled steel shape manufacturers;
- Semiconductor and related device manufacturers (examples of related devices include solar cells, transistors, voltage regulators);
- Carbon and graphite product manufacturers;
- Home furnishing merchant wholesalers;
- Roofing, siding, and insulation material merchant wholesalers; and
- Metal service centers and metal merchant wholesalers.
Check tomorrow’s Advisor for a review the exemptions and the compliance timeline for the nanomaterials reporting rule.