2010-31210. Public Information Exchange on EPA Nanomaterial Case Studies

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of Public Meeting to Receive Comments and Questions and To Provide Information on EPA Nanomaterial Case Studies and Their Purpose

SUMMARY:

EPA is announcing a public meeting to receive comments and questions on the EPA Nanomaterial Case Studies (http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​230972;​ http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​226723). This meeting will also afford EPA an opportunity to highlight the Nanomaterial Case Studies and how they are being used as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials.

All interested public parties are requested to register to attend this workshop. Space is limited, and reservations will be accepted on a first-come, first-served basis. Comments may be submitted in writing or as brief oral statements during specified periods of the meeting. EPA intends to consider all such comments in evaluating whether or how to develop further case studies and workshops on nanomaterials.

DATES:

The Public Information Exchange Meeting on the EPA Nanomaterial Case Studies will be held on January 4, 2011, beginning at 12:30 p.m. and ending no later than 3:30 p.m. Eastern Standard Time. Written comments should be submitted to EPA by December 28, 2010.

ADDRESSES:

The Public Information Exchange Meeting on the EPA Nanomaterial Case Studies will be held at the U.S. Environmental Protection Agency in Research Triangle Park, NC. To attend the workshop, please register no later than December 28, 2010, preferably by sending an e-mail to [e-mail]. Alternatively, you may register by calling Ms. Amalia Marenberg at ICF International at [phone].

EPA welcomes public attendance at the Public Information Exchange Meeting on the EPA Nanomaterial Case Studies and will make every effort to accommodate persons with disabilities. For information on access or services for individuals with disabilities, or if you have any other questions related to this meeting, please contact Ms. Amalia Marenberg of ICF International at [phone].

SUPPLEMENTARY INFORMATION:

I. Information About the EPA Nanomaterial Case Studies and Workshops

Engineered nanoscale materials (nanomaterials) have often been described as having at least one dimension between 1 and 100 nanometers (nm) and frequently possessing unusual, if not unique, properties that arise from their small size. Like all technological developments, nanomaterials offer the potential for both benefits and risks. The assessment of such risks and benefits requires information, but given the emergent state of nanotechnology, much remains to be learned about the characteristics and effects of nanomaterials before such assessments can be accomplished.

In its 2007 Nanotechnology White Paper (2007, p. 89), EPA included the following recommendations regarding the risk assessment of nanomaterials: (1) Develop case studies based on publicly available information on one or several intentionally produced nanomaterials, and from such case studies identify information gaps to help map areas of research that would support the risk assessment process; (2) hold a series of workshops involving a substantial number of experts from several disciplines to assist in this process.

In keeping with these recommendations, the National Center for Environmental Assessment (NCEA) in EPA's Office of Research and Development (ORD) prepared Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen [External Review Draft] (U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/057, 2009, http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​210206), released in July 2009, and subsequently held the “Nanomaterial Case Studies Workshop: Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Titanium Dioxide” on September 29-30, 2009, in Durham, North Carolina. A summary of the workshop may be found at: http://www.epa.gov/​osp/​bosc/​pdf/​nano1005summ.pdf. The summary document provides information on the design and conduct of the 2009 case studies workshop, noting that the Nanomaterial Case Studies Workshop was held under the auspices of the EPA Board of Scientific Counselors (BOSC), an advisory committee of independent scientists and engineers established by EPA to provide advice, information, and recommendations concerning practices and programs of the Office of Research and Development, including ORD's research planning process, in accordance with provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 [http://www.archives.gov/​federal-register/​laws/​fed-advisory-committee]) and related regulations. In August 2010, the BOSC provided comments on the case studies workshop (http://www.epa.gov/​osp/​bosc/​pdf/​nano1008rpt.pdf).

The Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen [External Review Draft] (http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​210206) was used as a starting point for the 2009 workshop. A key feature of the case studies is the comprehensive environmental assessment (CEA) framework, which takes a holistic view of specific applications of selected nanomaterials, beginning with the product life cycle and encompassing environmental fate and transport, exposure, and ecological as well as human health implications. CEA also includes a process component involving decision science methods, and this aspect of CEA was used in a workshop to identify and prioritize research or information needed to assess nanoscale titanium dioxide (nano-TiO₂).

It is important to note that the Nanomaterial Case Studies document and workshop were not intended to be ends in themselves, even though they may have value or be of interest in their own right. They were conceived as the first in a series of nanomaterial case studies and workshops to be used in developing and refining a long-term research strategy to support the comprehensive environmental assessment of selected nanomaterials for potential human health and ecological risks (U.S. EPA, 2009, 225004). Such a comprehensive strategy is expected to develop in an evolutionary process reflecting adjustments and modifications as additional nanomaterials are considered and new information becomes available.

The purpose of the Public Information Exchange Meeting scheduled on January 4, 2011, is to afford an opportunity for EPA to receive comments and questions and to provide information on the EPA nanomaterial case studies and associated workshops, including their purpose and rationale. The Information Exchange will be held from 12:30 p.m. to 3:30 p.m. in the Auditorium of the EPA facility in Research Triangle Park, North Carolina.

ICF International, a contractor to EPA, will conduct a separate meeting, the “ICF International Nanomaterial Case Studies Workshop: Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Silver,” at 3:45 p.m., January 4, 2011, in the same location. This workshop will be conducted with a selected set of invitee-only participants in a structured decision science process known as Nominal Group Technique (NGT), similar to the NGT process used in the 2009 workshop on nano-TiO₂ (http://www.epa.gov/​osp/​bosc/​pdf/​nano1005summ.pdf). The upcoming ICF workshop will use the EPA document Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray [External Review Draft] (U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-10/081, 2010, http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​226723) as a starting point for identifying and prioritizing possible research directions related to nanoscale silver. The ICF workshop is expected to conclude by 1 p.m. on Friday, January 7, 2011. Although funded by EPA, the ICF workshop is being conducted independently of EPA so as to comply with provisions of the Federal Advisory Committee Act (FACA). The ICF workshop will be open to public observers. Persons interested in obtaining more information about the workshop conducted by ICF International or in attending as an observer are asked to e-mail [e-mail] or call Ms. Amalia Marenberg at [phone]. Please indicate whether you are interested in attending the EPA Public Information Exchange Meeting or the ICF International NGT Workshop or both.

II. How To Submit Comments

The public comment period has closed for Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen [External Review Draft] (U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/057, 2009, http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​210206), which has now been completed and posted as a final version (http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​230972). Also closed is the public comment period for Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray [External Review Draft] (U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-10/081, 2010, http://cfpub.epa.gov/​ncea/​cfm/​recordisplay.cfm?​deid=​226723). However, comments on either of these documents, especially comments related to the approach used in developing the case studies and how they could be used in developing a comprehensive environmental assessment research strategy, are welcomed in connection with the EPA Public Information Exchange on the Nanomaterial Case Studies and may be used by EPA in evaluating whether or how to develop further case studies and workshops on nanomaterials. Comments may be submitted orally at specified times during the Public Information Exchange Meeting on the EPA Nanomaterial Case Studies on January 4, 2011. Comments may also be submitted in writing in advance of the meeting. Anyone who wishes to attend the meeting and/or submit comments orally or in writing should so indicate, preferably no later than December 28, 2010, by sending an e-mail to [e-mail] or by calling Ms. Amalia Marenberg at ICF International at [phone].

Dated: December 7, 2010.

Darrell A. Winner,

Acting Director, National Center for Environmental Assessment.