As EHS professionals, we have heard a lot of talk about nanomaterials and their possible effects on the environment. But what about worker safety? Today we will review the status of the U.S. Environmental Protection Agency’s (EPA) proposed reporting requirements for nanomaterials and the Agency’s recent approval of a pesticide containing nanosilver. Tomorrow we will look at the National Institute for Occupational Safety and Health’s (NIOSH) recent research concerning how nanomaterials affect worker safety and health.
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What are nanoscale materials?
Nanoscale materials (nanomaterials) are chemical substances that have structures with dimensions at the nanoscale level—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 from 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.
Proposed nanomaterials reporting requirements
As part of the requirements under the Toxic Substances Control Act (TSCA) Section 8(a), manufacturers and importers must submit a onetime Manufacturer’s Report—Preliminary Assessment Information (Manufacturer’s Report) for each plant site involved in manufacturing or importing a chemical substance.
EPA’s proposed reporting requirements for nanomaterials include:
- Reportable chemicals 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.
- Manufacturers and processors of multiple nanoscale forms of the same chemical substance would, in some cases, need to report separately for each discrete form of the reportable chemical substance.
- Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also have to be reported.
Proposed exemptions
Under EPA’s proposal, reporting would not be required for certain biological materials (e.g., DNA, RNA, and proteins), chemical substances that dissociate completely in water to form ions that are less than 1 nanometer, nanoclays, zinc oxide, and chemical substances manufactured at the nanoscale as part of a film on a surface.
Exemptions would also apply to small amounts of materials manufactured or processed for research and development purposes and to small businesses that meet EPA’s definition.
Also, the proposed requirements would not apply to chemical substances that have only trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100 nm, such that the chemical substance does not exhibit unique and novel characteristics or properties because of particle size.
When?
The EPA expects to issue the final rule, Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements, this coming October.
Nanoscale materials and pesticides
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA regulations provide a framework for registering pesticides that are a product of nanotechnology or that contain nanoscale materials.
The EPA is currently examining potential hazard, exposure, policy, regulatory, and international issues that may be associated with pesticides that are a product of nanotechnology or that contain nanoscale materials.
In the spring of 2015, the EPA issued a registration for a nanosilver-containing antimicrobial pesticide product named Nanosilva. This silver-based product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew. Items to be treated include, for example, household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories.
According to the EPA, the Agency’s decision was based on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature. Based on this evaluation, the EPA determined that Nanosilva will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products. The EPA is also requiring the company to generate additional data to refine the Agency’s exposure estimates.
Check out tomorrow’s Advisor for updates concerning NIOSH’s efforts to assess the effect of nanoscale materials on worker safety and health.
More and more facilities are affected by the growing regulation of nanomaterials. Be sure to check Enviro.BLR.com® for the information you will need to be compliant with these new regulations.