E7-15780. Material Characterization of Nanoscale Materials; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is convening a public scientific peer consultation meeting on material characterization for nanoscale chemical substances (“nanoscale materials”) to inform the development of its Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). The peer consultation on material characterization information for nanoscale materials is one of several actions EPA is taking to better understand the potential risks and benefits of nanotechnology. EPA is requesting comments at the public scientific peer consultation meeting regarding: Characteristics currently used or potentially available to characterize nanoscale materials; the rationale for the use of these characteristics; and issues to consider regarding use of these characteristics in the NMSP. These comments will inform EPA on material characteristics to be considered in the NMSP.

DATES:

The meeting will be held on September 6-7, 2007, from 8:30 a.m. to 5 p.m.

You may register for the meeting on or before August 31, 2007. See Unit IV. for additional information.

Comments must be received on or before 8:30 a.m., September 6, 2007.

Requests to present oral comments must be received on or before August 31, 2007. See Unit IV. for additional information.

To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

ADDRESSES:

The meeting will be held at the Holiday Inn Rosslyn at Key Bridge, 1900 Fort Myer Dr., Arlington, VA 22209.

For instructions on submission of requests to present oral comments in this meeting, see Unit IV.

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2004-122, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2004-0122. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is [phone]. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2004-0122. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Myrta Christian, Economics, Exposure and Technology Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]: e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of particular interest to those persons who manufacture, import, process, or use nanoscale materials that are chemical substances subject to the jurisdiction of TSCA. Potentially affected entities may include, but are not limited to:

• Chemical manufacturers (NAICS code 325), e.g., persons manufacturing, importing, processing, or using chemicals for commercial purposes.
• Petroleum and coal product industries (NAICS code 324), e.g., persons manufacturing, importing, processing, or using chemicals for commercial purposes.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket ID number EPA-HQ-OPPT-2004-0122. All documents in the docket are listed in the docket's index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

C. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

D. Where Can I Access More Information About Nanotechnology?

For more information about nanotechnology under TSCA, go to http://www.epa.gov/​oppt/​nano.

II. Background

There is a growing class of materials commonly referred to as engineered nanoscale materials. Materials having structures with the dimensions of roughly 1 to 100 nanometers, also known as nanoscale materials or nanoscale substances, may have organizations and properties different than the same chemical substances displayed at a larger scale. Nanoscale materials that meet the definition of “chemical substances” under TSCA are subject to TSCA. TSCA provides EPA with a strong framework for ensuring that new and existing chemical substances are manufactured and used in a manner that protects human health and the environment.

EPA is developing the NMSP for nanoscale materials to complement and support its new and existing chemicals programs under TSCA. The NMSP will also help to provide a firmer scientific foundation for regulatory decisions by encouraging the development of key scientific information and appropriate risk management practices. This peer consultation on material characterization is one of several actions EPA is taking to better understand the potential risks and benefits of nanotechnology.

On October 18, 2006, EPA invited the public, industry, environmental groups, other Federal agencies and other stakeholders to participate in the design, development, and implementation of the NMSP (see http://www.epa.gov/​oppt/​nano). On July 12, 2007, EPA announced the availability of several documents for public review and comment related to the further development of the NMSP, including the announcement of a public meeting on August 2, 2007, to discuss and take comment on these documents (Ref. 4, see also http://www.epa.gov/​oppt/​nano/​nmspfr.htm).

EPA is holding this public scientific peer consultation meeting to assist in elaborating characteristics used to describe nanoscale materials for the purposes of the NMSP. The public meeting will involve peer panel discussions of EPA’s discussion paper on possible material characteristics for the NMSP, with time allotted for public comment. EPA will place the discussion paper on possible material characteristics for nanoscale materials and the agenda for the meeting in the public docket, and on the OPPT nanotechnology website, Nanotechnology under the Toxic Substances Control Act, at http://epa.gov/​oppt/​nano/​index.htm.

For further information on input EPA has received or solicited regarding development of the stewardship program, see the Federal Register issues of May 10, 2005 (70 FR 24574-24576) (FRL-7700-7), October 4, 2006 (71 FR 58601-58603) (FRL-8070-3), and July 12, 2007 (72 FR 38083) (FRL-8139-2) and (72 FR 38079) (FRL-8140-2), as well as the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) Overview Document (Ref.1).

III. Discussion Items for EPA and Stakeholder Consideration

EPA has identified the following discussion items on material characterization for nanoscale materials for which your consideration and comment are specifically requested:

1. Description of nanoscale materials (e.g., types, categories).

2. Physical-chemical properties of potential interest (e.g., particle size/shape/distribution/dimensions, agglomeration, aggregation, surface area, etc.).

3. Design to achieve unique properties (e.g., manufacturing, processing, chemical transformations).

4. Obtaining characterization data for nanoscale materials (e.g., analytical methods, models).

5. Metrology (e.g., methods validation, standards, and harmonization).

6. Prioritization of characterization data and data gaps.

In addition, EPA is requesting information on characterization or methodology currently used for nanoscale materials. The Agency is also seeking comment on characterization or methodology that could potentially be used for nanoscale materials in the basic or the in-depth phases of the NMSP that were described in the “Concept Paper for the Nanoscale Materials Program under TSCA,” including the rationale for such use and any relevant issues (Ref. 4).

IV. How Can I Request to Participate in this Meeting?

You may register for the meeting electronically through EPA’s website at http://www.epa.gov/​oppt/​nano on or before August 31, 2007. Advance requests will assist in planning adequate seating; however, members of the public may attend without prior registration.

You may submit a request to present oral comments in this meeting to the technical person listed under FOR FURTHER INFORMATION CONTACT. Do not submit any information in your request that is considered CBI. Requests to present oral comments, identified by docket ID number EPA-HQ-OPPT-2004-0122, must be received on or before August 31, 2007.

V. References

The following references have been placed in the public docket that was established under docket ID number EPA-HQ-OPPT-2004-0122 for this action as indicated under ADDRESSES.

1. NPPTAC. November 22, 2005. Overview of Issues for Consideration byNPPTAC.

2. Discussion paper for public meeting on material characterization of nanoscale materials.

3. Agenda for public meeting on material characterization of nanoscale materials.

4. Concept Paper for the Nanoscale Materials Stewardship Program under TSCA.

List of Subjects

• Environmental protection
• Chemicals
• Hazardous substances
• Nanoscale materials

Dated: August 2, 2007.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.