Beveridge & Diamond
 
Related Practices
Related Practices

EPA Launches Nanotechnology Stewardship Efforts

Beveridge & Diamond, P.C., October 26, 2006

On October 19-20, 2006, EPA held its first of several public meetings to discuss the design and development of a voluntary stewardship program for nanoscale materials under the Toxic Substances Control Act (“TSCA”).  Nanoscale materials are materials one to 100 nanometers in length and may have different properties, including commercially valuable ones, than larger versions of the same materials.  EPA is developing the voluntary Nanoscale Materials Stewardship Program to encourage responsible commercial development of nanoscale materials by generating information about nanoscale materials and possible risk management concerns specific to these materials.

EPA has invited over 500 organizations and individuals from industry, environmental groups, academia, and other federal agencies to provide input on a number of issues and upcoming documents critical to the development of a nanoscale stewardship program.  According to EPA, these include: 1) risk management practices and characterization of nanoscale materials; 2) a framework document describing the TSCA program for nanoscale materials; 3) a document distinguishing between “new” and “existing” nanoscale materials for purposes of determining TSCA Inventory status; 4) a concept paper describing EPA’s thinking on the stewardship program and an Information Collection Request to collect data under the stewardship program; 5) workshops examining pollution prevention opportunities for nanoscale materials; and 6) a public meeting to discuss these documents and elements of the stewardship program.  (The invitation letter can be found at:  http://www.epa.gov/oppt/nano under “Highlights.”) 

Risk management practices were the subject of EPA’s October 19-20 meeting, which Beveridge & Diamond attorneys attended.  It was evident at the meeting that EPA’s plans for the stewardship program, including risk management practices, are still in the development stage.  The topics at this first meeting addressed potential worker safety components that might be included in a voluntary stewardship program in which program participants would submit information about their production or use of nanoscale materials, their nanotechnology workplace risk management practices in several categories (e.g., engineering controls, personal protective equipment), and the rationales for such measures.  Other topics included hazard communication, labeling, or customer training information that EPA might ask program participants to submit, nanomaterials waste management, and the more complete and detailed information that would be expected from participants in a subsequent “in-depth” program that is expected to focus on a more limited number of representative nanoscale materials for testing, risk mitigation technologies, and related research.  Companies that want to participate in the in-depth program would agree to extend application of risk management practices identified by EPA, and to conduct workplace, environmental, and worker health monitoring.

The discussions at the meeting left many questions unanswered.  Plans for the stewardship program have not yet evolved to the point of identifying the commitments participants will be asked to make or the incentives they will be offered to encourage participation.  One of the most important questions left to be answered is whether EPA will require participating companies in the “basic” program to undertake specific risk management practices or will merely be documenting such practices as they exist in practice.  The resolution of many of these issues is likely to coincide with EPA’s reaching consensus on the structure of  such programs with other OECD member countries that are contemplating stewardship programs of their own.

The open questions associated with EPA’s plans for the stewardship program reflect the uncertain state of EPA’s current approach to nanotechnology issues in general.  From a compliance point of view, many important regulatory issues remain unresolved, leaving companies already active in this area in a state of uncertainty regarding the regulatory status and implications of their efforts.  For example, EPA is expected to release soon a guidance document on the complex subject of whether, and under what circumstances, nanoscale versions of substances already on the TSCA inventory will be covered by the existing inventory listings or will instead be considered “new” substances for which premanufacture notifications must be submitted before commercial manufacture or import may begin.    

Additional opportunities to provide input on the stewardship program will be announced by EPA over the coming months, including at a November 2006 public meeting (specific date not yet announced) regarding nanoscale material characterization.  EPA has also created an e-mail distribution list for interested stakeholders.  More information is available at: http://www.epa.gov/oppt/nano

For more information, please contact Cindi Lewis at (202) 789-6018 (clewis@bdlaw.com), Russell LaMotte at (202) 789-6080 (rlamotte@bdlaw.com), or Ami Grace-Tardy at (202) 789-6076 (agrace@bdlaw.com).