On June 9, 2007, the U.S. Environmental Protection Agency (EPA) signed three Federal Register notices related to the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA) (appended). EPA intends to publish the notices in the July 12, 2007, Federal Register. The first notice announces a public meeting on August 2, 2007, to receive comments on the development of the voluntary NMSP. The second notice announces the availability of two draft documents for public review and comment: (1) “Concept Paper for the Nanoscale Materials Stewardship Program under TSCA” (Concept Paper); and (2) “TSCA Inventory Status of Nanoscale Substances -- General Approach” (TSCA Inventory Paper). The third notice solicits public comments on specific aspects of the proposed information collection request (ICR) for the voluntary NMSP. According to EPA, the purpose of the August 2, 2007, public meeting, which will occur during the comment period on the draft documents, is to further discussion and development of the NMSP. Registration for the meeting will be open until July 30, 2007, but is not necessary to attend the meeting. Registration will be available through the NMSP website at http://www.epa.gov/oppt/nano. Requests to make oral comments at the meeting are due July 30, 2007.
Draft Documents
The TSCA Inventory Paper describes EPA’s current thinking regarding whether a nanoscale material is a “new” or “existing” chemical substance under TSCA. The Concept Paper describes EPA’s general approach, issues, and considerations for the NMSP, and is intended to serve as a starting point for continuing work with stakeholders on the detailed design of the NMSP. Comments will be due 60 days after EPA publishes the notice of availability in the Federal Register, which EPA expects to occur on July 12, 2007.
EPA states that it developed the concept paper to outline its initial thinking about the NMSP. EPA will be working collaboratively with other federal agencies and stakeholders to further develop and implement the NMSP. Although dependent on the outcome of this development process, EPA envisions that the components of the NMSP could include:
- Assembling existing data and information from manufacturers and processors of existing chemical nanoscale materials;
- Encouraging the development of test data needed to provide a firmer scientific foundation for future work and regulatory/policy decisions; and
- Identifying and encouraging use of a basic set of risk management practices in developing and commercializing nanoscale materials.
The concept paper outlines proposed ideas for reporting on nanoscale materials in commerce, developing data on representative nanoscale materials, and identifying risk management practices. According to EPA, it describes who may wish to participate, the reporting expectations for participants, what the program could entail, and what EPA intends to do with the data generated from the program. It also describes the potential benefits of participation.
EPA will use the data from the NMSP to gain an understanding of which nanoscale materials are produced, in what quantities, how they are used, and the data that is available for such materials. EPA scientists will use data collected through the NMSP, where appropriate, to aid in determining how and whether certain nanoscale materials or categories of nanoscale materials may present risks to human health and the environment.
While EPA is seeking comment on all aspects of the NMSP and the TSCA Inventory Paper, EPA states that it “is especially interested in comments on the following items”:
- Whether the data elements that have been identified in the NMSP are appropriate for nanoscale materials.
- Timing and phasing of submissions under the NMSP basic and in-depth programs and whether approaches for tiering data submissions are appropriate.
- Who would participate in NMSP and how to encourage participation, especially from small- and medium-sized enterprises.
- What criteria to use for the NMSP program evaluation and views on the timing and nature of any reports EPA may issue.
- How to engage industry and other stakeholders in the NMSP in-depth program and approaches for generating test data.
- The processes and roles for EPA, participants, and other stakeholders during development and evaluation of data for the in-depth program.
- Possible approaches for identification and use of alternative sources of data, to minimize the burden of information collection associated with the NMSP.
- Uses for the data submitted to EPA under the NMSP.
- Issues relevant to scope, definitions, and descriptions.
- The suitability of the approach for determining the TSCA Inventory status of nanoscale materials discussed in the TSCA Inventory Paper.
- Whether, in combination, the TSCA Inventory Paper and the NMSP Concept Paper are sufficiently clear in how EPA plans to address nanoscale materials that are new or existing chemicals under TSCA and the NMSP and, if needed, an indication of areas where further clarification may be warranted.
Draft ICR
The draft ICR covers the information collection-related activities related to NMSP and the estimated paperwork burdens associated with those activities. EPA is soliciting public comments on specific aspects of the proposed information collection for the voluntary NMSP. Comments on the draft ICR are due 60 days after it is published in the Federal Register, which EPA expects to occur on July 12, 2007.
