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Nanomaterials in Government Regulations & Programs

The U.S. Environment Protection Agency (US EPA) is developing a Significant New Use Rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) to ensure that nanoscale materials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process certain nanoscale materials for an activity that is designated as a significant new use to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before commencing that activity. The SNUR would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and other information. The SNUNs would provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data. This information would help the Agency evaluate the intended use of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment. See Control of Nanoscale Materials under the Toxic Substances Control Act.

The US EPA is also considering regulating pesticides containing nanoscale material under the Federal Insecticide, Fungicide & Rodenticide Act (FIFR). Under the proposed notice, EPA would require pesticide manufacturers notify the EPA whether their production contain nanoscale materials under FIFRA section 6(a)(2) with any application for registration of a pesticide product that contains any nanoscale material. EPA will determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA).

In October 2010, the Food and Drug Agency (FDA) circulated a drafted document titled Guidance for Industry — Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. FDA intends to use the following principles when considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology:

  • An engineered material or end product that has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
  • An engineered material or end product that exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

These principles apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. This guidance document will be published in the Federal Register for public comment.

On December 17, 2010, the US National Organic Program (NOP) voted to accept the recommendation of the US National Organic Standards Board (NOSB) to prohibit engineered nanomaterials from the production, processing, and packaging of certified organic products.