EPA, ISO, OECD Team to Develop Nanotechnology Standards; EPA Seeks Data about Nanoscale Materials

February 13, 2008 // Published as a news service by IHS

The EPA also created a Nanoscale Materials Stewardship Program (NMSP) to address the human health and environmental risks and benefits of nanoscale chemical products.

Nanomaterial standards development
The ISO and the OECD are engaged in nanotechnology issues. The ISO established a technical committee to develop international standards for nanotechnology.

ISO/Technical Committee (TC) 229 is working to develop standards for terminology and nomenclature, metrology and instrumentation including:

• Specifications for reference materials.
• Test methodologies.
• Modeling and simulation.
• Science-based health, safety and environmental practices.

The OECD established a Working Party on Manufactured Nanomaterials (WPMN) that is engaged in projects to further the understanding of the properties and potential risks of nanomaterials including:

• Development of a database on environmental health and safety (EHS) research.
• EHS research strategies on manufactured nanomaterials.
• Safety testing of a representative set of manufactured nanomaterials.
• Manufactured nanomaterials and test guidelines.
• Cooperation on voluntary schemes and regulatory programs.
• Cooperation on risk assessments.
• The role of alternative methods in nano toxicology.
• Exposure measurement and exposure mitigation.

The EPA is participating in the working party and contributes to all of the projects. Of relevance to the in-depth portion of the EPA's NMSP is the project on safety testing of a representative set of manufactured nanomaterials.

The WPMN identified a representative list of manufactured nanoscale materials for environmental health and safety testing including:

• Fullerenes (C60).
• Single-walled carbon nanotubes (SWCNTs).
• Multi-walled carbon nanotubes (MWCNTs).
• Silver nanoparticles.
• Iron nanoparticles.
• Carbon black.
• Titanium dioxide.
• Aluminum oxide.
• Cerium oxide.
• Zinc oxide.
• Silicon dioxide.
• Polystyrene.
• Dendrimers.
• Nanoclays.

The WPMN also published a list of testing endpoints in the following areas:

• Nanomaterial information/identification.
• Physical-chemical properties.
• Material characterization.
• Environmental fate.
• Environmental toxicology.
• Mammalian toxicology.
• Material safety.

The WPMN launched a sponsorship program for testing manufactured nanomaterials. The OECD secretariat asked delegations about their willingness to sponsor or cosponsor one or more nanomaterials and endpoints.

The OECD will act as a clearinghouse for the sponsorship program and will prepare a guidance manual for sponsors. The EPA is sponsoring environmental effects and fate testing of fullerenes, SWCNTs, MWCNTs and cerium oxide.

Nanoscale Materials Stewardship Program (NMSP)
The NMSP program calls on manufacturers, importers, processors and users of engineered nanoscale materials to report to the EPA key information about these materials within six months. The EPA said it will evaluate the information to help ensure the safe manufacture and use of these nanoscale materials.

The EPA will also work with manufacturers, importers, processors and users of nanoscale materials to develop test data to provide a scientific basis for assessing the hazards, exposures and risks of nanoscale materials. The NMSP is designed to complement and support the EPA's new and existing chemical programs under the Toxic Substances Control Act (TSCA).

The NMSP includes, but is not limited to, existing chemical nanoscale materials manufactured or imported for commercial purposes as defined by the TSCA. The EPA encourages manufacturers and importers of new chemical nanoscale materials, which are subject to TSCA reporting requirements prior to manufacture as well as researchers to consider reporting under the NMSP.

The NMSP is touted as providing a scientific foundation for regulatory decisions by encouraging the development of key scientific information and use of risk management practices in developing and commercializing nanoscale materials, according to the EPA.

Nanotechnology under the Toxic Substances Control Act (TSCA)

Chemical nanoscale materials
Many nanomaterials are regarded as "chemical substances" under the TSCA. Engineered nanoscale materials range in size from 1-100 nanometers (nm) and may have very different properties than the same materials at a larger scale. This law provides the EPA with a framework for ensuring that new and existing chemical substances are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.

For example, the TSCA requires manufacturers of new chemical substances such as those not on the TSCA Chemical Substances Inventory to provide specific information to the EPA for review prior to manufacturing chemicals or introducing them into commerce. The EPA can require reporting or development of information to assess existing chemicals already in the marketplace.

Additionally, the EPA can take action to ensure that those chemicals that pose an unreasonable risk to human health or the environment are effectively controlled.

One of the key questions for manufacturers and importers is determining whether a given nanoscale material is listed on the TSCA Inventory or if it is a new chemical requiring premanufacture notification to the EPA. The EPA released the TSCA Inventory Status of Nanoscale Substances describing the EPA's thinking regarding whether a nanoscale material is a "new" or "existing" chemical substance under the TSCA.

The EPA received and reviewed new chemical notices under the TSCA for nanoscale materials and expects the number to increase in the future. The EPA took steps to control or limit exposures to these chemicals and also required testing to generate health and environmental effects data where appropriate. The EPA permitted limited manufacture of new chemical nanoscale materials through the use of administrative orders or significant new use rules under the TSCA.

The EPA said it also allowed the manufacture of new chemical-based nanoscale materials under certain regulatory exemptions but only in circumstances where exposures were tightly controlled to protect against unreasonable risks.

Source: U.S. Environmental Protection Agency (EPA).