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EPA/OPPTS

RIN: 2070-AJ30

Publication ID: Fall 2007

Title: Nanoscale Materials Under TSCA
Abstract: Nanoscale materials are chemical substances containing structures on the scale of approximately 1 to 100 nanometers, and may have different molecular organizations and properties than the same chemical substances on a larger scale. Because such materials may have novel properties and present novel issues, evaluating and managing health and environmental risks of nanoscale materials poses a new challenge. Under the Toxic Substances Control Act, EPA has the authority to require the development of data necessary for the assessment of chemical substances and mixtures from persons that manufacture or process them when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and environment from chemical substances and mixtures. The Office of Pollution Prevention and Toxics (OPPT) is establishing a voluntary program to assemble existing data and information from manufacturers and processors of certain nanoscale materials. With this assembled material, EPA will take appropriate steps to protect human health and the environment from unreasonable risk from these substances. In October 2006 EPA announced a collaborative process to design a nanoscale material stewardship program inviting 500 organizations and agencies to participate. On July 12, 2007, the Agency published a document that describes specific elements regarding a voluntary stewardship program for nanoscale materials, a proposed information collection request, and a paper that describes determining the TSCA inventory status of nanoscale materials. In addition, EPA conducted a public meeting on August 2 to receive oral comments on the stewardship program and the published documents. A notice announcing the stewardship program including final versions of any documents is scheduled to be published in February, 2008.
Agency: Environmental Protection Agency(EPA)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Prerule Stage
Major: No	Unfunded Mandates: No
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 15 USC 2601et seq

Legal Deadline: None

Statement of Need: There is evolving understanding of a new technology with regard to health and safety implications from exposure to nanoscale materials. This is also true in the areas of environmental fate, efficacy of exposure mitigation practices, etc. Therefore, at present the lack of information leads to challenges in the assessment of and decision-making on nanoscale materials.

Summary of the Legal Basis: Under TSCA, EPA has the authority to require the development of data adequate for the assessment of chemical substances and mixtures from persons that manufacture or process them, and to prevent and eliminate unreasonable risk of injury to human health and environment from chemical substances and mixtures.

Alternatives: The stewardship program is an effective yet flexible alternative to traditional regulatory approaches.

Anticipated Costs and Benefits: To be determined.

Risks: EPA will use information from the stewardship program to inform appropriate steps and future framework to protect human health and the environment from unreasonable risk.

Timetable:

Action	Date	FR Cite
Notice: TSCA Inventory Status	07/12/2007	72 FR 38083
Notice: Final Program Announcement	02/00/2008

Additional Information: SAN No. 5058; EPA publication information: Notice: TSCA Inventory Status - http://www.epa.gov/fedrgstr/EPA-TOX/2007/July/Day-12/t13558.htm; EPA Docket information: EPA-HQ-OPPT-2004-0122
Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal, State
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
RIN Data Printed in the FR: No
Agency Contact: Jim Alwood Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 1200 Pennsylvania Avenue NW, Mail Code 7405M, Washington, DC 20460 Phone:202 564-8974 Fax:202 564-9490 Email: alwood.jim@epa.gov Jim Willis Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M, Washington, DC 20460 Phone:202 564-0104 Fax:202 564-9490 Email: willis.jim@epamail.epa.gov