Chemical Nanoscale Materials
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OPPT is evaluating and, where appropriate, managing the risks associated with engineered nanoscale materials. Nanoscale materials at dimensions of roughly 1 to 100 nanometers may exhibit novel properties that enable applications that differ from the same materials at a larger scale. A nanometer is about one ten-thousandth the diameter of a human hair.
Nanoscale materials (NMs) that are "chemical substances" as defined under the Toxic Substances Control Act (TSCA) are subject to the law unless otherwise excluded. Thus TSCA pre-manufacture notifications (PMNs) are required to be submitted to EPA prior to manufacturing a "new" NM, i.e., a NM that is not currently listed on the TSCA Chemical Substances Inventory. The Agency will take steps to control or limit exposures to these NMs, and may require testing to generate health and environmental effects data where appropriate.
To assist potential PMN submitters, EPA has developed a document, TSCA Inventory Status of Nanoscale Substances -- General Approach (2008) (PDF) (7 pp, 37K, About PDF), describing EPA's current thinking regarding whether a nanoscale material is a "new" or "existing" chemical substance under TSCA. This document was published for public review and comment prior to its release in January 2008.
On January 28, 2008, OPPT initiated a Nanoscale Materials Stewardship Program (NMSP) aimed at gathering currently available information on NMs. Its goal is to help provide a firmer scientific foundation for regulatory decisions by encouraging submission and development of key scientific information, including risk-management practices for nanoscale materials. Companies that manufacture, import, process, or use nanoscale materials for commercial purposes, as well as researchers, were invited to participate. On January 12, 2009, EPA released its interim report on the status of the NMSP and possible next steps.
OPPT chairs and is actively participating in the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials and its projects to further understanding of the properties and potential risks of nanomaterials.
- As of July 8, 2008, four companies submitted information, and ten companies and two trade associations committed to submit information under the basic program of the Nanoscale Materials Stewardship Program (NMSP). Read the most current information on program participants. EPA has encouraged participants in the basic program to submit existing data by July 28, 2008.
OPPT announced a variety of opportunities for public input on the program's development in 2007, including a request for comments on: a paper outlining the Agency's initial concept; an information collection request; and other materials connected to the program.
- OPPT and EPA’s Office of Research and Development (ORD) hosted the Pollution Prevention Through Nanotechnology Conference September 25-26, 2007, to exchange ideas and information on using nanotechnology to prevent pollution.
- OPPT and ORD co-chaired the development of an EPA Nanotechnology White Paper (PDF) (136 pp, 4.12MB, About PDF) , which was issued in February 2007, describing why EPA is interested in nanotechnology across its programs, the Agency's statutory mandates, and risk assessment issues specific to nanotechnology across media.
- With EPA in the lead, the OECD’s Working Party on Manufactured Nanomaterials launched a "sponsorship program" for countries to share testing information on the human health and environmental safety of a representative set of 14 manufactured nanomaterials. The OECD Secretariat asked delegations to sponsor or co-sponsor one or more nanomaterials and endpoints. As part of its commitments, EPA is sponsoring environmental effects and fate testing of fullerenes, single-walled carbon nanotubes, multi-walled carbon nanotubes, and cerium oxide, and is encouraging participation by other U.S. entities in the OECD work.