Last month I distributed an article which discussed the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for nanoscale materials. That proposal is still under review. This article discusses measures the EPA has already taken concerning nanoscale materials and why you should keep up to date on the efforts to regulate nanoscale materials

Recap: What are Nanoscale Materials?

Nanomaterials are chemical substances that have structures with dimensions at the nanoscale—approximately 1 to 100 nanometers. To get an idea of their size, a human hair is approximately 80,000 to 100,000 nanometers wide. These materials are currently used in hundreds of consumer products, including electronics, cosmetics, clothing, food, and medicines.

Some potential hazards of nanoparticles include inhalation and absorption hazards. The small particles could be asbestos-like, depending on the material, when inhaled or absorbed through the skin.

Nanoscale Materials and TSCA

Nanoscale materials that meet the TSCA definition of “chemical substance” are subject to TSCA. If a “new” chemical substance is manufactured at the nanoscale, it is subject to the same premanufacture notification (PMN) review requirements under TSCA that are applicable to any new chemical.

Since 2005, the EPA has received and reviewed over 160 new chemical notices under TSCA for nanoscale materials. The Agency has permitted limited manufacture of new chemical nanoscale materials through the use of administrative orders or significant new use rules (SNURs) under TSCA Section 5(a). For example, the EPA has issued a SNUR for multi-walled carbon nanotubes. Once the EPA determines that a use of a chemical substance is a significant new use, persons must submit a significant new use notice (SNUN) to the EPA at least 90 days before they manufacture, import, or process the chemical substance for that use.

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.

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.

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.

Earlier this spring, 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.

This has drawn the consternation of some groups who take issue with EPA’s fast-tracking of pesticides in general. For example, in comments to EPA’s proposal to register Nanosilva, the Natural Resources Defense Council (NRDC), along with a number of environmental groups, said the EPA staff reviewing the data on Nanosilva do not appear to have the necessary expertise to adequately describe nanosilver materials. NRDC et al. also complained that EPA’s conditional registration program, under which Nanosilva was registered, is too flawed to be used.

Outlook

The production and use of nanoscale materials in innumerable products will continue and the EPA is involved on both the domestic and the international front in an effort to assess the benefits and risks of nanotechnology. Under an Executive Order from President Obama, the EPA, along with all executive departments and agencies, are required to approach the issue and study of nanotechnology neutrally and not make generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.

For more information or assistance with your Environmental and Health & Safety regulatory compliance needs, contact Ralph Carito at Total Environmental & Safety, LLC (Total) at rcarito@TotalEnviron.com or 908-442-8599.