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Environmental Protection Agency (EPA)


Report Title: Regulatory Plan and Semiannual Regulatory Agenda
Report ID: 514
Date: 12/7/2009
Report Type: Government Report
URL: [regagendabook-fall09.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: Twice annually EPA publishes its Semiannual Regulatory Agenda, which details the agency’s priorities and planned rulemakings for the upcoming year. In this document, the fall 2009 agenda, the EPA has announced that a TSCA Section 4(a) test rule may be needed to determine the health effects of certain multi-wall carbon nanotubes and nanosized clays and alumina. Such a rule would be proposed by November 2010, and would require manufacturers to perform health tests and submit the data to the EPA. Additionally, in this agenda the EPA has also announced that it is using its TSCA Section 8(a) authority to develop a proposal for requiring manufacturers of certain nanoscale materials to notify the EPA of production volume, methods of manufacturing and processing, exposure and release information, and available health and safety data. The EPA has not announced which "certain nanoscale materials" it would target. The EPA plans to develop this proposal by June 2010.
Archived Copy: regagendabook-fall09_514_5483.pdf



Report Title: EPA Clarifies Significant New Use Rules for Carbon Nanotubes
Report ID: 487
Date: 7/29/2009
Author: Nanowerk Business News
Report Type: News Article
Publication: Nanowerk Business News
URL: [newsid=11901.php]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: On June 24, 2009, the EPA issued Significant New Use Rules (SNURs) for twenty-three chemical substances, including two carbon nanotubes (see report ID 196). Manufacturers, importers, and processors of affected substances must notify the EPA 90 days prior to their use. Following the issuance of the SNURs, stakeholders asked the EPA for clarification as to whether the SNURs apply to all variants of carbon nanotubes. The EPA has issued a statement clarifying that the SNURs only apply to the specific carbon nanotubes that were previously the subject of the premanufacture notices (PMNs) under Section 5 of the TSCA. Other carbon nanotubes are not affected by this SNUR but notification must be made to the EPA under its New Chemicals Program.
Archived Copy: EPA clarification_487_6686.pdf



Report Title: Test Rule; Multiwall Carbon Nanotubes
Report ID: 474
Date: 3/1/2009
Report Type: Proposed Rule
URL: [eAgendaViewRule]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: In its Spring 2009 Regulatory Agenda, the EPA announced that it may create a Toxic Substances Control Act (TSCA) section 4(a) test rule to determine the health effects of multiwall carbon nanotubes. Such a rule would require manufacturers of multiwall carbon nanotubes to perform health tests and submit the data to the EPA. To create such a rule, the EPA must demonstrate a possibility of exposure (although this can be inferred), and must also make statutory "data inadequacy" and "testing is necessary" findings. Section 4 test rules are created through a formal rulemaking process requiring public comment. The EPA believed that this rule might be needed to gather information so workers handling carbon nanotubes will be able to protect their health. Subsequent to this notice, the EPA proposed significant new use rules (SNURs) under section 5(a)(2) of the TSCA for carbon nanotubes (see report ID 415).
Archived Copy: testrule_474_2553.pdf



Report Title: Proposed Significant New Use Rule for Multi-walled Carbon Nanotubes
Report ID: 460
Date: 2/3/2010
Author: Environmental Protection Agency (EPA)
Report Type: Government Communication
Publication: Federal Register (Vol. 75, No. 22)
URL: [PDFgate.cgi]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The EPA is proposing significant new use rules (SNURs) for certain multi-walled carbon nanotubes. Affected nanotubes are those with premanufacture notice P-08-199; these nanotubes are used as an additive for polymer composites and in industrial catalysts. Because the EPA believes that using these nanotubes in a manner different than that specified in P-08-199 (use with gloves, protective clothing, and a full-face respirator) could result in increased worker exposure to nanoparticles, companies who use the nanotubes in a different manner are required to notify the EPA at least 90 days prior to beginning their manufacture, import, or processing. This advance notice will permit the EPA to assess the risk of the intended uses and to regulate them, if appropriate, before the use occurs. In the case of multi-walled carbon nanotubes, the EPA has determined that their use without such protective equipment could cause serious health effects. The comment period for these proposed rules ended on March 5, 2010.
Archived Copy: newuserule_460_3878.pdf



Report Title: U.S. Environmental Protection Agency Nanotechnology White Paper
Report ID: 431
Date: 2/1/2007
Author: members of the Nanotechnology Workgroup, a group of the EPA's Science Policy Council
Report Type: White Paper
URL: [whitepaper12022005.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The purpose of this paper is to inform EPA management of the scientific needs associated with nanotechnology, to support related EPA program office needs, and to communicate these nanotechnology science issues to stakeholders and the public. To help EPA focus on priorities for the near term, the paper concludes with staff recommendations for addressing science issues and research needs, and includes prioritized research needs within most risk assessment topic areas (e.g., human health effects research, fate and transport research). In a separate follow-up effort to this White Paper, EPA’s Nanotechnology Research Framework, attached in Appendix C of this paper, was developed by EPA's Office of Research and Development (ORD) Nanotechnology Research Strategy Team.
Archived Copy: whitepaper12022005_431_4809.pdf



Report Title: Nanotechnology: National Nanotechnology Coordinating Office (NNCO) Interagency Research Meeting/Workshop – Nanotechnology and the Environment: Applications and Implications
Report ID: 426
Date: 6/1/2003
Author: National Center for Environmental Research, National Nanotechnology Coordinating Office
Report Type: Meeting Notes
URL: [09-15-2003.html]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: Approximately seventy-five government, academic, and industry participants convened September 15 and 16 for the Interagency meeting sponsored by the NNCO-- Nanotechnology and the Environment: Applications and Implications. Overall, the conference focused on how agencies within the federal government viewed their research agenda as it relates to the environment--applications to and prevention of environmental problems, and possible harmful effects that might arise. Eighteen papers that were presented dealt the implications of nanotechnology to the environment. The conference ended with discussion breakouts on 5 topics: economic benefits of nanotechnology for the environment; workplace and manufacturing issues; precautions, procedures and perceptions; creating a nanotechnology/environmental community (communications, interactions, international links, agency cross-cutting issues); and research needs.



Report Title: Proceedings: EPA, Nanotechnology, and the Environment: Applications and Implications STAR Progress Review Works
Report ID: 425
Date: 2/1/2003
Author: The Office of Research and Development’s National Center for Environmental Research
Report Type: Meeting Notes
URL: [2002_august_nano_star_workshop.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The EPA Nanotechnology Grantees Workshop brought together researchers from academia, industry, and government to discuss ongoing research on nanotechnology and the environment. This report briefly summarizes the presentations. The results from the EPA-sponsored nanotechnology research outlined within this document have the potential to be used to monitor and remediate environmental problems, curb emissions from a wide range of sources, and develop new “green” processing technologies that minimize the generation of undesirable by-product effluents. In addition, the results offer fundamentally new ways to manufacture new chemicals and pharmaceutical products; measure, control, and remediate contaminants in various media; and contribute to dematerialization resulting in less environmental impact from the extraction, transport, manufacture, use, and disposal of materials.
Archived Copy: 2002_august_nano_star_workshop_425_3907.pdf



Report Title: Proposed Significant New Use Rules
Report ID: 415
Date: 11/6/2009
Author: Environmental Protection Agency
Report Type: Government Communication
Publication: Federal Register / Vol. 74, No. 214/ Friday, November 6, 2009 / Proposed Rules
URL: [E9-26818.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: EPA is proposing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of pre-manufacture notices. The two substances are identified generically as multi-walled carbon nanotubes (P–08– 177) and single-walled carbon nanotubes (P–08–328). The proposed SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders. This action would require persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Archived Copy: EPA nanotube SNUR_415_9841.pdf



Report Title: Certain Chemical Substances; Withdrawal of Significant New Use Rules
Report ID: 384
Date: 8/21/2009
Author: Environmental Protection Agency
Report Type: Notice
Publication: Federal Register, Vol. 74, No. 161
URL: [t20150.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The EPA is withdrawing two significant new use rules (SNURs) promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of premanufacture notices (PMNs), i.e., multi-walled carbon nanotubes (PMN P–08–177) and single-walled carbon nanotubes (PMN P–08– 328). These chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. EPA published the SNURs using direct final rulemaking procedures. EPA received a notice of intent to submit adverse comments on these rules. Therefore, the Agency is withdrawing these SNURs, as required under the expedited SNUR rulemaking process. EPA also intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.
Archived Copy: EPA SNUR Withdrawal_384_1245.pdf



Report Title: ‘The North Face’ Clothing Parent Company Facing Nearly $1M in Federal Fines Following Unsubstantiated Product Claims
Report ID: 383
Date: 9/22/2009
Author: Mary Simms
Report Type: News Article
URL: [bcbd9b468b9aaf67852576390055de2f!OpenDocument]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The U.S. Environmental Protection Agency has filed suit against San Leandro based VF Corporation for the alleged sale and distribution of unregistered pesticides through their retail company, The North Face. The EPA maintains that The North Face made unsubstantiated public health claims regarding unregistered products, and their ability to control germs and pathogens -- a violation of the Federal Insecticide, Fungicide, and Rodenticide Act. At issue were more than seventy styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. After being contacted by EPA, The North Face stopped making claims that their footwear protects against germs, removed claims from their website, and revised their product packaging.
Archived Copy: EPA North Face Press Release_383_6929.pdf



Report Title: Sixty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments
Report ID: 209
Date: 8/4/2009
Author: Environmental Protection Agency (EPA)
Report Type: Notice
URL: [PDFgate.cgi]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: This notice contains the sixty-fourth report of the Toxic Substance Control Act (TSCA) Interagency Testing Committee (ITC). Under the TSCA, the EPA is authorized to require testing of chemicals for the purpose of gathering data used in determining risks that such chemicals may pose to people or to the environment. During this period of November 2008 to May 2009, the ITC reviewed the EPA’s interim report on the Nanoscale Materials Stewardship Program and intends to develop a rule under TSCA section 8(a) to obtain information on the production, uses, and exposures of nanomaterials. This document contains a list of chemicals for which the EPA believes it needs data pertaining to occupational exposure and toxicity; these chemicals will either be included in the proposed TSCA rule or classified as new substances requiring premanufacture notification (PMN) reporting. The EPA additionally intends to develop a TSCA section 4 rule to develop further environmental and safety data on these chemicals. Some chemicals included on this list are: Carbon-60 fullerenes, titanium oxide nanowires, quantum dots, and nano silver.
Archived Copy: EPA Nanomaterials data call in notice_209_7463.pdf



Report Title: Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and Topical Sunscreen
Report ID: 208
Date: 7/31/2009
Author: Environmental Protection Agency (EPA)
Report Type: Notice
URL: [PDFgate.cgi]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: This notice of a public comment period is intended to gather pre-dissemination peer review of the EPA’s draft document, “Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and Topical Sunscreen.” This document examines two potential uses of nanoscale titanium dioxide: Water treatment and sunscreen. Because evaluating nanomaterials in the abstract sense is difficult, the EPA commissioned these specific case studies to aid in the creation of a long-term research strategy for environmental assessment of nanomaterials. They follow the “comprehensive environmental assessment” approach, which assesses a product’s direct and indirect effects throughout its life cycle. The studies present a structure for analyzing nanomaterials and provide a prioritization for the areas of research needed to enable future studies. The 45-day public comment period on this draft study began on July 31, 2009 and ends on September 14, 2009.
Archived Copy: EPA Case studies fed reg notice E9-18386_208_5284.pdf



Report Title: Significant New Use Rules on Certain Chemical Substances
Report ID: 196
Date: 6/24/2009
Author: EPA
Report Type: Notice
URL: [PDFgate.cgi]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: The EPA is establishing new significant use rules (SNURs) for twenty-three chemical substances, including numerous poorly soluble particulates, two of which are single-walled and multi-walled carbon nanotubes. Under the Toxic Substances Control Act (TSCA), manufacturers, importers, and processors of these substances must notify the EPA 90 days in advance before beginning any activities. This notification period is intended to provide the EPA with sufficient time to limit or prohibit activities as needed. Section 5(a)(2) of the TSCA provides the EPA with this authority and lists the factors considered when creating new SNURs, which include projected volume, increased exposure to humans or the environment, and methods of disposal. Carbon nanotubes are subject to the new SNURs based upon test data of other poorly soluble particulates (i.e. asbestos). As a result, the EPA suggests a 90-day inhalation toxicity study on rats. With these new rules, use of carbon nanotubes now requires a full-face respirator and clothing to protect against inhalation and dermal exposure.
Archived Copy: EPA Nanotube SNUR_196_3006.pdf



Report Title: In the Matter Of: Aten Technology Inc. D/b/a Iogear, Inc., No. Fifra-09-2008-003
Report ID: 194
Date: 2/27/2008
Author: Environmental Protection Agency (EPA)
Report Type: Settlement Agreement
Publication: http://www.penmedia.org/download/settlement.pdf
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: ATEN Corporation, Inc., operating under the name IOGEAR, Inc., is a manufacturer of computing accessories. IOGEAR manufactured and sold its Laser Travel Mouse with nano shield coating as well as three other computer mice products, all of which claimed that the nano shield coating had mechanisms to deactivate enzymes and proteins to prevent bacteria from survivingthe compound has been tested and proven effective against various bacteria. The EPA initiated action against IOGEAR, claiming that the sale of an unregistered pesticide violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The act requires the registration of pesticides before their distribution or sale. Because of its intention to destroy bacteria on an external surface, the nano shield coating was a pesticide under FIFRA. This docket contains the settlement reached with the EPA, which did not require IOGEAR to admit to the EPAs allegations. IOGEAR paid a $208,000 civil penalty.
Archived Copy: EPA ATEN settlement_194_3286.pdf



Report Title: Nanotechnology: Basic Information
Report ID: 180
Date: 2/26/2008
Author: Environmental Protection Agency
Report Type: Webpage
URL: [Default.htm]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: This webpage provides a basic introduction to nanotechnology. Nanotechnology is the art and science of manipulating matter at the atomic or molecular scale. The document lists the National Nanotechnology Initiatives definition of nanotechnology and discusses types of nanotechnology structures such as nanoparticles, nanocrystal, and nanotubes. It also provides examples of how nanotechnology can improve everyday life.
Archived Copy: Michael Vincent EPA (2008), Basic nanotechnology info_180_6890.pdf



Report Title: Toxic Substances Control Act Inventory Status of Carbon Nanotubes
Report ID: 109
Date: 10/27/2008
Report Type: Notice
URL: [main]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: This document gives notice of the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNTs). The EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory. Many CNTs may therefore be new chemicals under TSCA section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA section 5 where required under 40 CFR part 720 or part 723. In order to determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import under 40 CFR 720.25.



Report Title: Nanoscale Materials Stewardship Program
Report ID: 108
Date: 1/28/2008
Report Type: Notice
URL: [main]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: This document describes the design and format of EPA's Nanoscale Materials Stewardship Program (‘‘the program'') for nanoscale materials under the Toxic Substances Control Act (TSCA). On July 12, 2007, EPA sought public comment on a concept paper that outlined its initial thinking on the design and development of the program, and several related documents. Based on ideas in the concept paper, written public comments, comments at public meetings, and scientific peer consultations on material characterization and risk management practices, EPA has developed this document to provide the final description and format of the program. EPA will consider refinements to the program over time based on experience and additional feedback from participants.



Report Title: Meeting Summary Report: Nanoscale Materials Stewardship Program
Report ID: 104
Date: 8/8/2007
Author: Eastern Research Group, Inc
Report Type: Meeting Notes
URL: [mtgsummary080207.pdf]
Country: United States of America
Organization: Environmental Protection Agency (EPA)
Summary: On August 2, 2007, the EPA held a public meeting on the voluntary Nanoscale Materials Stewardship Program (NMSP). The NMSP is a program for the self-reporting of characteristics of nanomaterials, with the aim of developing a regulatory framework for ensuring consumer and manufacturing safety. A broad range of participants attended, including academia, non-governmental organizations (NGOs), government, industry, the press, and the public. The meeting discussed the development of the voluntary NMSP and its parameters, such as test procedures and methods for companies to submit data. This document summarizes the comments and agenda of this meeting.



 
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