Environmental Protection Agency (EPA).
EPA will conduct a public meeting on nanoscale materials to discuss a potential voluntary pilot program for certain nanoscale materials and the information needed to adequately inform the conduct of the pilot program. 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. Some of the nanoscale materials are new chemical substances subject to notification requirements under section 5 of the Toxic Substances Control Act (TSCA) and, therefore, are subject to review for potential human health and environmental risks before they are manufactured and enter commerce. Other nanoscale materials are existing chemical substances that may enter commerce without notification to EPA. EPA is considering a potential voluntary pilot program for such nanoscale materials. To that end, EPA is requesting comments at the public meeting on: (1) The scope and purpose of a voluntary pilot program for nanoscale materials that are existing chemical substances, (2) kinds of information that are relevant to the evaluation of potential risks from exposure to nanoscale materials, (3) chemical characterization and nomenclature of nanoscale materials for regulatory purposes, and (4) identification of interested stakeholders. These comments will inform EPA on possible approaches to protect human health and the environment from exposure to such chemical substances.
The meeting will be held on June 23, 2005, from 9 a.m. to 5 p.m.
Requests to provide oral comments at the meeting must be received in writing by the technical person listed under FOR FURTHER INFORMATION CONTACT: before June 9, 2005. Please note that time for oral comments may be limited, depending on the number of requests received.
Requests to attend the meeting may be submitted to the technical person listed under FOR FURTHER INFORMATION CONTACT: by June 16, 2005. Please note that this advance request will assist in planning adequate seating; however, members of the public can attend without prior notification to the technical person. Requests for special accommodations may be submitted to the technical person by June 16, 2005.
Written comments, identified by docket identification (ID) number OPPT-2004-0122, may be submitted to the docket at any time before the meeting date.
The meeting will be held at the Washington Plaza, 10 Thomas Circle NW., Washington, DC 20005.Start Further Info
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: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
For technical information contact: Flora Chow, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8983; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 TSCA jurisdiction. Potentially affected entities may include, but are not limited to:
- Chemical manufacturers (NAICS 325), e.g., persons manufacturing, importing, processing, or using chemicals for commercial purposes.
- Petroleum and coal product industries (NAICS 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.Start Printed Page 24575
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this action under docket ID number OPPT-2004-0122. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B-102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA docket center reading room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.
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/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.
About two decades ago, research indicated that certain nanoscale materials exhibit unexpectedly unique and novel properties. The existence of structures at the nanoscale level may confer a distinct set of physical, chemical, and biological properties.
EPA is interested in whether commercial activities of nanoscale materials may present a potential risk to human health and the environment because of their unique physical structure and consequent properties. Available information on potential hazards and exposures is limited (Refs. 1 and 2). Therefore, EPA is considering how best to evaluate the risks associated with nanoscale materials and how to manage those risks. TSCA is often viewed as a regulatory gap filler, which is intended to provide regulatory and information collection authority lacking in some other environmental statutes (Refs. 3, 4, and 5). TSCA applies to chemical substances and mixtures. The term “chemical substance” means any organic or inorganic substance of a particular molecular identity. The term specifically excludes: Pesticides; tobacco or tobacco products; certain nuclear materials; firearms and ammunition; food; food additives; drugs; cosmetics; and medical devices. Chemical substances when used in these other categories fall under the jurisdiction of other federal laws.
Among TSCA's regulatory tools are reporting requirements that apply prior to manufacture or import of any new chemical substance, and the ability of EPA to regulate a substance prior to commencement of manufacture if it appears that it may involve unreasonable risk of injury to health or the environment. A chemical substance is “new” if it is not on the TSCA Chemical Substance Inventory (the TSCA Inventory), EPA's official list of existing chemical substances. Therefore, a chemical substance that is a nanoscale material not on the TSCA Inventory (i.e., a new chemical substance) must be reported to EPA in a premanufacture notification (PMN) under section 5 of TSCA before commercial activities are allowed. EPA has authority under section 5 to review potential health and environmental risks of all aspects of the commercial activities (Ref. 3). Once a new chemical substance completes the PMN process and has been listed on the TSCA Inventory, the chemical substance is considered to be an existing chemical substance. A chemical substance that is a nanoscale material on the TSCA inventory (i.e., an existing chemical substance), absent other requirements, is not subject to EPA review prior to manufacture or use. Existing chemical substances that present an unreasonable risk of injury to human health or the environment may be regulated under section 6 of TSCA (Ref. 3). Because currently available chemical representation and nomenclature conventions may not be adequate for some nanoscale materials, ambiguity exists regarding how and when to distinguish nanoscale materials as new or existing chemical substances. In the current state of development of structural characterization upon which nomenclature conventions are based, issues remain.
In addition to regulatory tools, EPA engages in voluntary partnerships with the chemical industry and other stakeholders to facilitate risk reduction activities. These activities are generally less resource intensive and offer more flexible approaches to management of potential risks. Recent examples of voluntary programs on existing chemicals are the High Production Volume (HPV) Challenge Program and the Voluntary Children's Chemical Evaluation Program (VCCEP). Both programs are designed to provide information on certain groups of chemicals. Evaluation of this information will enable a better public understanding of potential hazards and exposures.
EPA is considering a pilot program of voluntary reporting of information pertaining to nanoscale materials that are existing chemical substances. Information derived from a pilot program will 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 expects that the following parameters will be important in the context of a potential voluntary pilot program to provide information on nanoscale materials.
- What should be the scope of a voluntary pilot program?
- What information should be included in a voluntary pilot program? What other pertinent information regarding the properties of the particular nanoscale material would be relevant to EPA review?
- How long should a voluntary pilot program last?
- How should participants in the voluntary pilot program be identified?
- What should trigger a voluntary submission under the pilot program?
- How likely would it be for companies to volunteer for such a program? What could be the incentive structure to encourage participation?
- Should participation in a voluntary pilot program have TSCA Inventory consequences? A voluntary pilot program would not affect the TSCA Inventory status of a nanoscale material that is an existing chemical substance. As indicated previously, nanoscale materials that are not listed on the TSCA Inventory are considered new chemical substances. These new chemical substances require the submission of a PMN before they can be manufactured or used for commercial purposes.
III. Issues for EPA and stakeholders
In general, EPA is requesting comments on the following issues: (1) The scope and purpose of a voluntary pilot program for nanoscale materials that are existing chemical substances, (2) kinds of information that are relevant to the evaluation of potential risks from exposure to nanoscale materials, (3) chemical characterization and nomenclature of nanoscale materials for regulatory purposes, and (4) identification of interested stakeholders. Comments in these specific areas will be particularly helpful:
- Feasibility and value of a voluntary pilot program.
- Scope and design of a voluntary pilot program, including elements such as: purpose (e.g., R & D, use involving environmental release, any commercial use), administration, outcomes, duration, and next steps.
- Information that would be useful in the evaluation of potential effects on human health and the environment from exposure to nanoscale materials.
- Size, dimensions, and shapes of chemical substances that should be considered nanoscale materials.
- Types of information (e.g., unique and novel properties) that would be useful to provide for purposes of: informing the voluntary pilot program; and helping to name and characterize nanoscale materials (including features to distinguish them from otherwise similar chemical substances that do not involve nanoscale structures).
- Manufacturing processes for nanoscale materials and how they relate to identities of the products from the nanoscale manufacturing processes.
- Identification of interested stakeholders.
The following references have been placed in the official docket that was established under docket ID number OPPT-2004-0122 for this action as indicated in Unit I.B.2.
1. Aitken, R.J., Creely, K.S., Tran, C.L. 2004. Nanoparticles: An Occupational Hygiene Review. Suffolk, U.K.: Health and Safety Executive, Research Report 274.
2. VDI Technologiezentrum GmbH. 2004. Industrial Application of Nanomaterials - Chances and Risks. Technology Analysis. Luther W, ed. Dusseldorf, Germany: Future Technologies No. 54.
3. USEPA. 2005. Considerations Relevant to Toxic Substances Control Act (TSCA) Application to Nanoscale Materials. Office of Prevention, Pesticides and Toxic Substances. Office of Pollution Prevention and Toxics.
4. Federal Register. June 3, 2003. TSCA Section 8(e): Notification of Substantial Risk; Policy Clarification and Reporting Guidance. 68 FR 33129.
5. Federal Register. January 12, 2005. TSCA Section 8(e) Reporting Guidance; Correction, Clarification of Applicability, and Announcement Regarding the Issuance Questions and Answers. 70 FR 2162.Start List of Subjects
List of Subjects
- Environmental protection
- Hazardous substances
- Nanoscale materials
Dated: April 25, 2005.
Susan B. Hazen,
Assistant Administrator for Prevention, Pesticides and Toxic Substances.
[FR Doc. 05-9324 Filed 5-9-05; 8:45 am]
BILLING CODE 6560-50-S