E6-16385. Risk Management Practices for Nanoscale Materials; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is convening a public meeting on risk management practices under a possible stewardship program for nanoscale materials under the Toxic Substances Control Act (TSCA). EPA is considering development of a stewardship program for such nanoscale materials. This program is being explored to encourage responsible commercial development of nanoscale materials. The stewardship program will also enable EPA, affected industry, and other stakeholders to build the capacity to assess potential risks to human health and the environment from nanoscale materials and to identify risk management practices available to reduce such potential risks. EPA is requesting comments at the public meeting on: Risk management practices currently used or potentially available for use for nanoscale materials, the rationale for the use of these practices and the effectiveness or efficiency of these practices, and issues to consider for including risk management practices for nanoscale materials in the stewardship program. These comments will inform EPA on risk management practices to include in the stewardship program.

DATES:

The meeting will be held on October 19, 2006, from 8 a.m. to 5 p.m., and on October 20, 2006, from 8 a.m. to 2:30 p.m.

Comments must be received on or before 8 a.m., October 19, 2006.

Requests to present oral comments must be submitted to the technical person listed under FOR FURTHER INFORMATION CONTACT before October 16, 2006. Time for oral comments may be limited, depending on the number of requests received.

Requests to attend the meeting may be submitted electronically through the Eastern Research Group (ERG) registration website at https://www2.ergweb.com/​projects/​conferences/​nano by October 16, 2006. Advance requests will assist in planning adequate seating; however, members of the public may attend without prior registration. Requests for special accommodations may also be submitted through the ERG registration website by October 16, 2006.

ADDRESSES:

The meeting will be held at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024.

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2004-0122, 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, 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.

Docket: All documents in the docket are listed in the regulations.gov index. 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, EPA Docket Center (EPA/DC). The EPA/DC suffered structural damage due to flooding in June 2006. Although the EPA/DC is continuing operations, there will be temporary changes to the EPA/DC during the clean-up. The EPA/DC Public Reading Room, which was temporarily closed due to flooding, has been relocated in the EPA Headquarters Library, Infoterra Room (Room Number 3334) in EPA West, located at 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. EPA visitors are required to show photographic identification and sign the EPA visitor log. Visitors to the EPA/DC Public Reading Room will be provided with an EPA/DC badge that must be visible at all times while in the EPA Building and returned to the guard upon departure. In addition, security personnel will escort visitors to and from the new EPA/DC Public Reading Room location. Up-to-date information about the EPA/DC is on the EPA website at http://www.epa.gov/​epahome/​dockets.htm.

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: Scott Prothero, 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.

Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may have an interest in this matter. 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. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit CBI 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 on a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM that you mail to EPA 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.

II. Background

Nanoscale materials are chemical substances containing structures in the length scale of approximately 1 to 100 nanometers, and may have different molecular organizations and properties than the same chemical substances in a larger size.

EPA is considering a stewardship program pertaining to these nanoscale materials. (See the Federal Register of May 10, 2005 (70 FR 24574-24576) (FRL-7700-7.) Information derived from the stewardship program would allow EPA and the affected industry to better understand the issues with respect to potential risks and for EPA to gain experience in the evaluation of such types of chemical substances.

EPA has received input from the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) regarding the intended outcomes of a voluntary program in the form of an Overview Document (Ref.1). The Overview Document indicates that the program should:

1. Give EPA and the public a better understanding of the types of nanoscale materials produced in the United States. Characteristics of these materials that should be identified include: Physical, chemical, hazard and exposure characteristics; production volume; and the uses of the materials.

2. Help EPA develop a capacity and process for identifying and assessing risks of engineered nanoscale materials.

3. Help EPA determine what information it needs about engineered nanoscale materials and articulate those information needs to industry and other stakeholder groups.

4. Help EPA understand what risk management practices are being employed during production, processing, use and disposal stages, and what additional risk management practices should be considered for implementation.

5. Prompt or reinforce the implementation of risk management practices.

6. Provide the information and experience needed to develop an overall approach to the treatment of nanoscale chemical substances under TSCA that builds public trust in nanoscale materials while enabling innovation and responsible development. The Overview Document indicated that participants in the program should implement basic risk management practices or other environmental or occupational health protection controls (e.g., worker training, hazard communication (including Material Safety Data Sheet (MSDS)), use of available engineering controls, provision of personal protective equipment, product labeling, customer training, waste management practices, etc.). The Overview Document also suggested that, in developing the program, EPA should hold one or more public peer consultation meetings. Among other issues, the meeting(s) would address risk management practices to be included in a basic program and in an in-depth program, each offered under the overall program (Ref. 1).

EPA is holding this public meeting to assist in elaborating possible risk management practices for the stewardship program. The public meeting will involve panel discussions of EPA's discussion paper on possible risk management practices for the basic program, with time allotted for public comment. EPA will place in the public docket and the ERG registration website the discussion paper on possible risk management practices for nanoscale materials as well as an agenda for the meeting.

III. Issues for EPA and Stakeholders

EPA is requesting comments on the following risk management practices for nanoscale materials:

1. Worker training, including work practices.

2. Hazard communication.

3. Engineering controls.

4. Personal protective equipment.

5. Product labeling.

6. Customer training.

7. Waste management and environmental release management.

Comments in these specific areas will be particularly helpful:

• Risk management practices currently used for nanoscale materials.
• Risk management practices that could potentially be used for nanoscale materials.
• Rationale for the use of these practices and the effectiveness or efficiency of these practices.
• Issues to consider for determining risk management practices for nanoscale materials to include in the basic program.
• Comments on EPA's proposed risk management practices for nanoscale materials in the basic program.

EPA is also requesting comments on:

1. Other risk management practices for nanoscale materials that should be considered.

2. Consideration for possible additional risk management practices for nanoscale materials in the in-depth program.

IV. 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 by NPPTAC.

2. Discussion paper for public meeting on risk management practices for nanoscale materials.

3. Agenda for public meeting on risk management practices for nanoscale materials.

List of Subjects

• Environmental protection
• Chemicals
• Hazardous substances
• Nanoscale materials

Dated: September 22, 2006.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.