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Report Title: General Principles and Practices for Working Safely with Engineered Nanomaterials
Report ID: 577
Date: 12/15/2009
Author: Stanford University
Report Type: Guidance Document
URL: [Working_Safely_with_Engineered_Nanomaterials.pdf]
Country: United States of America
Organization: Stanford University (US)
Summary: This document provides environmental, health, and safety guidance to researchers working with engineered nanomaterials in Stanford University laboratories. Stanford University has been at the forefront of nanomaterial safety (see report ID 453) among California nanomaterial users. This document supplements Stanford’s existing chemical hygiene plan and laboratory safety toolkit. Specifically, it addresses engineering controls, selection of nanomaterials, safety equipment, hygiene, labeling and signage, cleaning, transporting, a buddy system, personal protective equipment, training, standard operating procedures, and consultation. The document also describes the risk of exposure for various nanomaterial activity types and the primary control measures to be used for each type of activity.
Archived Copy: Working_Safely_with_Engineered_Nanomaterials_577_5159.pdf



Report Title: Best Practices for Handling Nanomaterials in Laboratories
Report ID: 574
Date: 8/1/2010
Author: Massachusetts Institute of Technology (MIT)
Report Type: Guidance Document
URL: [University_Best_Practices.pdf]
Country: United States of America
Organization: Massachusetts Institute of Technology (MIT)
Summary: The Massachusetts Institute of Technology has created this list of best practices for handling nanomaterials based upon the recommendations of other universities. These practices include knowing the existing toxicity information, preplanning experiments, preventing inhalation exposure, preventing dermal exposure, using eye protection, using signage, being aware of fire/explosion hazards, preventing contamination of laboratory surfaces, spill cleanup, nanomaterial waste management, transporation of nanomaterials off-site, and monitoring exposure.
Archived Copy: University_Best_Practices_574_5909.pdf



Report Title: Nanomaterials: Potential Risks and Safe Handling Methods
Report ID: 569
Date: 1/1/2004
Author: Pennsylvania State University
Report Type: Webpage
URL: [nanomaterials.cfm]
Country: United States of America
Organization: Pennsylvania State University
Summary: This webpage describes the potential health risks of nanomaterials and safe handling methods. Presently, it is uncertain whether nanomaterials can pass through skin so inhalation and dermal exposures should be prevented. Gloves should be worn when handling particulates and solutions containing nanoparticles. There are currently no government occupational exposure standards for nanomaterials. Also, some material safety data sheets (MSDSs) have incorrect information because they refer, for example, to the graphite exposure standard when carbon nanotubes have different properties than graphite. Safe work practices must be implemented until the exact nature of the risks are known.



Report Title: Nanomaterials Safety and Health Guideline for Carbon-based Nanomaterials
Report ID: 566
Date: 9/21/2010
Author: NASA Ames Research Center
Report Type: Webpage
URL: [APR1700.1C50.html]
Country: United States of America
Organization: NASA (US)
Summary: This NASA guideline dictates the procedural requirements for handling nanomaterials in NASA’s Ames research laboratory. Compliance with these requirements is mandatory. Procedures include weighing dry, loose nanoparticles in a fume hood or glove box, manipulating quantities of dry, loose nanoparticles only in fume hoods or glove boxes unless a job hazardous analysis is performed, wearing safety goggles and gloves, and avoiding skin contact. Unique to NASA is the handling of lunar dust for grinding and milling. A job hazard analysis and personal protective equipment analysis must be undertook before manipulating quantities of dry dust. Wiping of work area surfaces is also required. Specific procedures are also given for handling zinc oxide, cadmium selenide, and gold, among other substances.



Report Title: Safe Working Practices Information Page
Report ID: 565
Date: 7/17/2009
Author: Virginia Commonwealth University
Report Type: Guidance Document
URL: [nanotech.pdf]
Country: United States of America
Organization: Virginia Commonwealth University
Summary: Virginia Commonwealth University has developed these guidelines to ensure that university employees conduct nanotechnology research in a safe and responsible manner. They point out occupational exposure hazards of carcinogenicity, genotoxicity, cytotoxicity, and toxicity. Principal investigators are directed to reduce or eliminate exposure as much as possible through administrative controls, personal protective equipment, work practices, engineering controls, waste disposal, and cleanup of spills. Investigators must also comply with other university policies and in vivo nanomaterial studies must be approved.
Archived Copy: nanotech_565_2959.pdf



Report Title: Nanosafety Program
Report ID: 563
Date: 6/1/2011
Author: Florida State University
Report Type: Webpage
URL: [lab-nano.html]
Country: United States of America
Organization: Florida State University
Summary: Florida State University has a number of research programs which use nanomaterials. Accordingly, the university has implemented this nanosafety program to ensure proper handling protocols. FSU requires total enclosure of the particle handling process, total enclosure of stored stocks and nanomaterials, the handling of only solutions on the lab bench, sealed secondary containment devices for transport, treatment of waste as hazardous, and limited access in research areas, among other requirements.



Report Title: Nanoparticle Handling Guidelines
Report ID: 560
Date: 7/1/2008
Author: University of Oklahoma
Report Type: Guidance Document
URL: [NanoparticleGuidelines.doc]
Country: United States of America
Organization: University of Oklahoma
Summary: This document provides nanomaterial handling guidelines for the University of Oklahoma. Among the engineering, work practice, and ventilation controls required for working with nanomaterials are: Lab coats, gloves, arm sleeves in some cases, safety glasses, fume hoods, closed container transport of nanoparticles, and hand-washing afterwards. If nanoparticles are administered to animals, the Institutional Animal Care and Use Committee must additionally approve the project. If nanoparticles are administered to humans, the Institutional Review Board must additionally approve the project.
Archived Copy: NanoparticleGuidelines_560_5104.doc



Report Title: Standard Operating Procedure for the Use and Synthesis of Engineered Nanomaterials
Report ID: 559
Date: 6/18/2011
Author: University of Delaware
Report Type: Operating Procedure
URL: [NanomaterialSOP.doc]
Country: United States of America
Organization: University of Delaware
Summary: The University of Delaware’s Chemical Hygiene Plan requires that employees using nanomaterials complete this form, explaining how the nanomaterials will be used in research, requiring the researcher to read a statement explaining safety, and requiring the employee to fill out contact information, describe the safety measures that will be taken, and complete checklists and provide information such as who will e responsible for various precautionary measures.
Archived Copy: NanomaterialSOP-1_559_2836.doc



Report Title: Nanotechnology: Guidelines for Safe Research Practices
Report ID: 555
Date: 9/1/2008
Author: University of California Lab Safety Work Group
Report Type: Information Sheet
URL: [NanoFacts2008.pdf]
Country: United States of America
Organization: University of California
Summary: This fact sheet provides guidance to University of California employees on safely handling nanomaterials. There are four possible routes of workplace exposure to nanomaterials: inhalation, ingestion, skin absorption, and injection. In some cases, nanomaterials have been shown to migrate through skin and therefore gloves must be worn. To prevent ingestion, spills should be cleaned up and workers should not eat or drink in laboratories. To prevent inhalation, nanomaterials should be handled in a form not easily made airborne such as in solution. Lastly, workers should take precautions to avoid accidentally injecting themselves with nanomaterials. These basic suggestions are expounded upon in twelve safety guidelines which should be followed.
Archived Copy: NanoFacts2008_555_4329.pdf



Report Title: Nanotechnology Consensus Workplace Safety Guidelines
Report ID: 551
Date: 4/3/2009
Author: Mercer
Report Type: Webpage
URL: [Default.htm]
Country: United States of America
Organization: Mercer
Summary: This website provides a list of tools and reference materials for implementing workplace safety guidelines, and was created by the ORC (now Mercer) Task Force on Nanotechnology. Nine areas of interest are: Assessing hazard characteristics, assessing worker exposure, assessing process safety considerations, assessing environmental emissions & fate, performing health, safety, and environment risk assessment, implementing health, safety, and environment risk control, medical monitoring, communication and training, and assessing transportation needs.



Report Title: Lab Safety Guidelines for Handling Nanomaterials
Report ID: 550
Date: 6/1/2011
Author: American Chemical Society
Report Type: Webpage
URL: [content]
Country: United States of America
Organization: American Chemical Society
Summary: These lab safety guidelines implement stringent controls on exposure, which should be continued until more knowledge becomes available regarding nanomaterial safety. Among the recommendations are: Skin contact should be avoided; good general laboratory safety practices should be used; respiratory protection should be used if handling powders outside of a filtered fume hood; evaluate equipment for prior contamination; consider the explosive reactivity of certain nanomaterials; and follow hazardous chemical waste guidelines in disposing of nanomaterials.



Report Title: Working with Nanomaterials
Report ID: 543
Date: 9/1/2008
Author: National Cancer Institute at Frederick
Report Type: Advisory Report
URL: [C-19%20Nanoparticle%20Safety.pdf]
Country: United States of America
Organization: National Cancer Institute at Frederick
Summary: In the absence of published regulations for safe working practices with nanomaterials, the National Cancer Institute at Frederick has set its control strategies and risk assessments based upon the most current toxicological data, exposure assessments, and exposure control information that is available. Nanomaterials are handled using the same precautions currently used when handling toxic materials or materials of unknown toxicity. Control strategies are: Engineering controls (e.g. ventilation systems), good work practices, personal protective equipment, administrative controls, clean-up of nanomaterial spills, animal studies, MSDSs, and keeping current with literature.
Archived Copy: C-19 Nanoparticle Safety_543_2216.pdf



Report Title: Interim Best Practices for Working with Nanoparticles
Report ID: 541
Date: 10/1/2008
Author: M. Ellenbecker & S. Tsai
Report Type: Guidance Document
URL: [Best_Practices_for_Working_with_Nanoparticles.....]
Country: United States of America
Organization: Center for High-Rate Nanomanufacturing
Summary: This guidance document was published by the National Science Foundation’s Science and Engineering Center for High-rate Nanomanufacturing to protect laboratories from unknown nanomaterial hazards. It emphasizes a precautionary approach to working with nanoparticles and follows the Precautionary Principle in reducing exposure to the lowest possible level until the science has concluded that there is no risk. The three possible routes of exposure are airborne, dermal, and ingestion. Basic principles for minimizing exposure include keeping nanoparticles bound in a matrix or solution rather than in a free particle state, following a hierarchy of hazard controls of engineering controls, administrative controls, and personal protective equipment, and best work practices.
Archived Copy: Best_Practices_for_Working_with_Nanoparticles_Version_1_541_3876.pdf



Report Title: Nano Risk Framework
Report ID: 534
Date: 6/1/2007
Author: Environmental Defense—DuPont Nano Partnership
Report Type: Guidance Document
URL: [6496_Nano%20Risk%20Framework.pdf]
Country: United States of America
Organization: Environmental Defense—DuPont Nano Partnership
Summary: As a joint product of DuPont and the Environmental Defense Fund, this nanotechnology risk framework is intended to promote the responsible development of nanotechnology products. It recommends developing informational profiles (“base sets”) regarding the properties, hazards, and exposures associated with a given nanomaterial and its application. These profiles extend to a product’s lifecycle with a greater emphasis on ecotoxicity and environmental fate than traditional risk frameworks. The framework consists of six steps: Describe material and application; profile lifecycles; evaluate risks; assess risk management; decide, document, and act; and review and adapt. Particularly relevant now due to knowledge gaps, the framework also allows for using reasonable worst-case assumptions where insufficient data exists.
Archived Copy: 6496_Nano Risk Framework_534_2973.pdf



Report Title: Application of a Pilot Control Banding Tool for Risk Level Assessment and Control of Nanoparticle Exposures
Report ID: 533
Date: 7/1/2008
Author: Samuel Paik et al.
Report Type: Study
Publication: The Annals of Occupational Hygiene
URL: [419.full.pdf+html]
Country: United States of America
Organization: Lawrence Livermore National Laboratory
Summary: This study introduces control banding (CB) strategies for characterizing the health aspects of working with engineered nanoparticles. The “CB Nanotool,” when applied to existing nanotechnology-related operations, found that four of five implemented controls consistent with the CB Nanotool’s suggestions. This CB Nanotool appears to have promise for assessing the risk of nanomaterial operations.
Archived Copy: 419.full_533_4406.pdf



Report Title: Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials
Report ID: 527
Date: 8/16/2007
Author: National Science and Technology Council
Report Type: Request for Opinion
URL: [Prioritization_EHS_Research_Needs_Engineered_.....]
Country: United States of America
Organization: National Science and Technology Council (US)
Summary: After the release of the National Nanotechnology Initiative (NNI)'s "EHS Research Needs for Engineered Nanoscale Materials" report, the Nanotechnology Environmental and Health Implications (NEHI) Working Group solicited public comment on prioritization of environmental, health, and safety research needs. This document contains the Working Group's twenty-five priorities and requests public comments. Prioritization of research needs has been undertaken with three principles in mind: Prioritize research based on the value of information, leverage research funded by other governments when appropriate, and use adaptive management for research. Earlier public comments suggested prioritizing short-term research if the research has the opportunity to provide useful results or is relevant to technology nearing commercialization. High priority research needs include developing methods to detect nanomaterials in biological matrices, the environment, and the workplace; developing methods to quantify and characterize exposure to nanomaterials; understand the effects of nanomaterials in individuals of a species; and identify population groups exposed to nanomaterials.
Archived Copy: Prioritization_EHS_Research_Needs_Engineered_Nanoscale_Materials_527_8119.pdf



Report Title: Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials
Report ID: 525
Date: 9/1/2006
Author: National Science and Technology Council
Report Type: Advisory Report
URL: [NNI_EHS_research_needs.pdf]
Country: United States of America
Organization: National Science and Technology Council (US)
Summary: As part of the National Nanotechnology Initiative (NNI), the National Science and Technology Council established the Nanotechnology Environmental and Health Implications Working Group in 2003. The Working Group prepared this document to list research needs and to inform research, risk assessment, and risk management activities. These research needs will be further prioritized and gaps between them and existing research will be addressed. In the area of instrumentation, metrology, and analytical methods, there is a need to standardize definitions and methods for assessing particle shape, structure, and surface area. In the area of human health, many routes of exposure for nanoparticles remain unknown and research is needed to gain an understanding of transport and absorption of nanomaterials throughout the body. With regard to the environment, more study is needed to understand how nanomaterials transform under different environmental conditions. Other areas of concern include workplace exposure and monitoring protocols and risk management. For 2007, the federal government intends to budget $44 million for environmental, health, and safety research to begin to address these concerns.
Archived Copy: NNI_EHS_research_needs_525_7396.pdf



Report Title: Nanotechnology in California
Report ID: 523
Date: 1/1/2010
Author: California Council on Science and Technology
Report Type: General Report
URL: [2010Nano.pdf]
Country: United States of America
Organization: California Council on Science and Technology
Summary: This report provides an overview of California's nanotechnology industry, which had 1,400 companies from 1990 to 2008. It is estimated that California will have 90,000 nano-related jobs by 2015. California also has numerous nanotechnology research institutes, including the California Nanosystems Institute (CNSI), a joint venture between universities. CNSI has research priorities in energy, environment, health (medicine), and information technology industry areas. CNSI also partners with small firms to offer research and development services at CNSI facilities. California is leading the country in nanotechnology regulation; California has the only mandatory reporting requirement in the world. The California Department of Toxic Substances Control (DTSC) has launched the California Nanotechnology Initiative (CNI), which requests that California manufacturers of nanomaterials supply data used for safety assessments. So far the DTSC has launched a call-in for data pertaining to carbon nanotubes (see report IDs 100 and 453). Planned call-in topics include nano silver, reactive nanometals, dendrimers, and quantum dots. State law also requires the DTSC to adopt regulations by January 2011 that establish a process for identifying "chemicals of concern," which may include nano products.
Archived Copy: 2010Nano_523_5165.pdf



Report Title: OTA Technology Guidance Document: Nanotechnology – Considerations for Safe Development
Report ID: 521
Date: 8/1/2010
Author: Massachusetts Office of Technical Assistance
Report Type: Guidance Document
URL: [ota_nanotech_guidance.pdf]
Country: United States of America
Organization: Massachusetts Office of Technical Assistance
Summary: This guidance document from the Massachusetts Office of Technical Assistance makes recommendations for the safe development of nanotechnology. It is suggested that facilities handling engineered nanoparticles develop a risk reduction program that prevents exposures, even if the harm from exposure is not yet fully known. The risk reduction plan should be divided into two levels: direct and eventual potential impact. Design options that render nanoparticle-containing products safer to end users and the environment will not only reduce risk, but also legal liability. Worker safety programs should evaluate air movement near potential nanoparticle release points and ensure that free nanoparticles do not become inhaled by workers. It is also suggested that nanoparticles with lower toxicity or other non-nano materials be substituted for high toxicity nanoparticles, if possible. For example, adjusting the fiber length of carbon nanotubes may reduce toxicity. Containment and ventilation controls must be used to ensure that nanoparticles are not released into the workplace, and when this is not possible, personal protective equipment (PPE) should be used. Recommendations for preventing facility releases, transparency of information, recognizing the value of prevention, and realizing the value of nanotechnology are also contained in this document.
Archived Copy: massachusetts - considerations for safe development_521_6613.pdf



Report Title: Nanomaterials Are Widely Used in Commerce, but EPA faces Challenges in Regulating Risk
Report ID: 518
Date: 5/1/2010
Report Type: Study
URL: [d10549.pdf]
Country: United States of America
Organization: Government Accountability Office (US GAO)
Summary: The world market for nanomaterial-containing products is expected to reach $2.6 trillion by 2015. Because of the incredible growth in nanotechnology, the GAO undertook this study, which identifies current and potential uses of nanomaterials, determines what is known about potential health and environmental effects, assessed the EPA's actions to date on nanomaterials, and identified the approaches of states and other countries in addressing potential risks. The GAO found that current understanding of human and environmental risks is limited and that the toxicity of a nanomaterial depends on numerous factors, all of which combine to make it difficult to generalize regarding safety. Although there have been safety studies, these have yielded limited risk information because the results of one study may not be applicable to another, even within the same class of nanomaterials such as carbon nanotubes. Furthermore, although the EPA has been working to regulate nanomaterials, a nanochemical is new for purposes of regulation only if it has a molecular identity not already listed on the TSCA inventory. Since the EPA does not consider molecule size or reactivity in determining if a chemical is a new substance, it is possible for nanoscale versions of existing chemicals to escape EPA regulation. The GAO recommends that the EPA should complete its plan to clarify that nanoscale versions of existing chemicals should be regulated as new substances. The study also recommends that the EPA should use its authority to gather more health and safety information and require the identification of nanomaterial ingredients in pesticides.
Archived Copy: gao nano epa_518_3197.pdf



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: Strategy for Nanotechnology-Related Environmental, Health, and Safety Research
Report ID: 511
Date: 2/1/2008
Report Type: Government Report
URL: [NNI_EHS_Research_Strategy.pdf]
Country: United States of America
Organization: National Science and Technology Council (US)
Summary: In 2001, the National Nanotechnology Initiative was created to support the responsible development of nanotechnology. This document is the NNI's strategy for advancing research on the environmental, health, and safety aspects of nanomaterials. The National Research Council subsequently reviewed (see report ID 73) this strategy. The strategy calls for several federal groups to work together, including NIOSH, the FDA, and the EPA. Research priorities include developing methods to detect nanomaterials in biological matrices, developing methods for standardizing assessment of particle size, understanding the absorption and transport of nanomaterials throughout the body, developing in vivo and in vitro models for predicting human response to exposure, and understanding workplace exposure. All of the priorities and funding estimates for them are listed in this strategy.
Archived Copy: NNI_EHS_Research_Strategy_511_5931.pdf



Report Title: Strategic Plan for NIOSH Nanotechnology Research and Guidance
Report ID: 503
Date: 11/1/2009
Report Type: General Report
URL: [2010-105.pdf]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: This strategic plan outlines NIOSH's planned research for 2009-2012, which is aimed at filling critical knowledge gaps and comprises 38 activities in ten critical areas. As part of NIOSH activities, in 2004, NIOSH established the Nanotechnology Research Center (NTRC) to conduct research and provide guidance to protect occupational worker exposure to nanoparticles. For 2009-2012, NIOSH will conduct toxicological research on nanoparticles likely to be commercially available, conduct research to identify long-term health effects of carbon nanotubes (CNT), and develop recommendations for controlling occupational exposure to titanium dioxide nanoparticles and carbon nanotubes. NIOSH is also working on methods to identify categories of nanoparticles and their physico-chemical properties. The plan also addresses how NIOSH can align its research with the National Nanotechnology Initiative and other strategic plans.
Archived Copy: 2010-105_503_2277.pdf



Report Title: Manufactured Nanoparticle Health and Safety Disclosure
Report ID: 501
Date: 12/5/2006
Author: City of Berkeley Community Environmental Advisory Commission (CEAC)
Report Type: Legislation
URL: [2006-12-05%20Item%2013%20Manufactured%20Nanop.....]
Country: United States of America
Organization: Berkeley City Council
Summary: In December 2006, the city of Berkeley, California became the first government entity in the United States to approve a law requiring the reporting of nanomaterials used in local facilities. This document is from the December 5 City Council meeting and is the agenda item recommending the adoption of the ordinance and containing the text of the ordinance. Berkeley's law provides that all facilities that manufacture or use manufactured nanoparticles must submit a written disclosure to the city. This disclosure must contain the current toxicological profile of the nanoparticles and a description of how the facility will safely manage them. The ordinance applies to all particles with one axis less than 100 nanometers in length. Prior to the passage of the ordinance, Berkeley required disclosures of hazardous substances upon reaching a set threshold. This ordinance extends the disclosure to encompass all nanoparticle usage regardless of aggregate quantity.
Archived Copy: ordinance_501_5932.pdf



Report Title: National Nanotechnology Initiative Amendments Act of 2009
Report ID: 496
Date: 7/21/2009
Author: Senator John Kerry (D-MA)
Report Type: Proposed Legislation
URL: [legislation.111s1482]
Country: United States of America
Organization: United States Senate
Summary: The National Nanotechnology Initiative Amendments Act of 2009 was a bill introduced in the 111th Congress to amend the 21st Century Nanotechnology Research and Development Act to expand the scope of the National Nanotechnology Program (NNP). The bill provides for support by the NNP of the development of standardized reference materials, participation in national and international organizations developing standards, sponsorship of nanotechnology education and workforce development programs, and coordination of research. It also charges the Director of the National Nanotechnology Coordination Office with developing and maintaining a publicly accessible database of projects funded by the Nanoscale Science, Engineering, and Technology subcommittee of the National Science and Technology Council.
Archived Copy: S1482_496_3561.pdf



Report Title: SBIR/STTR Reauthorization Act of 2009
Report ID: 495
Date: 6/10/2009
Author: Senator Mary Landrieu (D-LA)
Report Type: Proposed Legislation
URL: [legislation.111s1233]
Country: United States of America
Organization: United States Senate
Summary: The SBIR/STTR Reauthorization Act of 2009 was proposed legislation in the 111th Congress to reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs of the Small Business Administration. Section 206 of the bill amends the Small Business Act such that through October 2014, every federal agency participating in the SBIR/STTR programs shall encourage the submission of applications for support of nanotechnology-related projects. As of July 2010, this bill was on Senate Calendar No. 94.
Archived Copy: S1233_495_5754.pdf



Report Title: Nanotechnology Innovation and Prize Competition Act of 2009
Report ID: 494
Date: 3/16/2009
Author: Senator Ron Wyden (D-OR)
Report Type: Proposed Legislation
URL: [legislation.111s596]
Country: United States of America
Organization: United States Senate
Summary: The Nanotechnology Innovation and Prize Competition Act of 2009 directs the Secretary of Commerce to establish an award program to honor achievements in nanotechnology. This bill was introduced by Senator Ron Wyden in the 111th Congress, and creates financial and recognition prizes for individuals and companies who apply nanotechnology to improve the environment, develop alternative energy, improve human health, or develop consumer products. As of July 2010, the bill has languished in the Senate Committee on Commerce, Science, and Transportation since its introduction.
Archived Copy: S596_494_9362.pdf



Report Title: Frequently Asked Questions
Report ID: 488
Date: 6/28/2010
Report Type: Webpage
URL: [default.htm]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: This webpage from the FDA contains a list of frequently asked questions and answers regarding nanotechnology and the FDA's role in its regulation. Although the FDA has not established a definition of nanotechnology, it participated in the National Nanotechnology Initiative (NNI)'s development of a definition. Existing requirements are anticipated to be effective for most nanotechnology products subject to FDA regulation. Some nanotechnology-containing products, such as cosmetics, are outside of the FDA's regulatory scope. However, it is anticipated that there will be new nanotechnology products and these are likely to be in "combination form" (i.e. drug-device, drug-biologic, device-biologic products). For combination products, a specific sector of the FDA will be assigned primary regulatory jurisdiction, depending on the "primary mode of action" of the product. Approval will be obtained either through a single application or through separate applications, depending on the jurisdiction and safety/effectiveness concerns.
Archived Copy: FAQ_488_8072.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: Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, for Toxicity of Nanomaterials
Report ID: 486
Date: 8/27/2009
Author: US Food and Drug Administration (FDA)
Report Type: Notice
Publication: Federal Register, Vol. 74, No. 165
URL: [E9-20634.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: The Food and Drug Administration (FDA) has signed a memorandum of understanding (MOU) with an Air Force Research Laboratory to facilitate information sharing in the areas of toxicogenomic and computational toxicology research. The parties intend to coordinate their research efforts in developing new tools and technologies to understand the biological response to environmental stressors, including nanomaterials. The research objectives include studying nanomaterials and the blood-brain barrier, identifying appropriate biosignatures of exposure to nanomaterials, identifying computational methods of understanding biological responses to exposure, and producing publications in peer-reviewed scientific journals. This notice from the Federal Register contains a copy of the entire memorandum, which will last for 36 months unless the parties choose to extend or cancel it.
Archived Copy: E9-20634_486_4619.pdf



Report Title: Developing standards for nanotechnologies – an international perspective
Report ID: 479
Date: 5/19/2006
Author: Peter Hatto
Report Type: PowerPoint Presentation
URL: [hatto.pdf]
Country: United States of America
Summary: This presentation was given on May 19, 2006 at the symposium on "Nanotechnology Governance: Environmental Management from an International Perspective" held at Vanderbilt University. Dr. Peter Hatto, chairman of an ISO nanotechnology standardization committee, described the basics of standards, including their purpose and the structure of the ISO, before highlighting the urgent need for nanotechnology standardization. Currently there are no internationally agreed definitions, protocols for toxicity testing, or protocols for evaluating environmental impact of nanotechnologies. Measurement techniques and instruments must be developed, and new reference materials are needed for validating the instruments on a nanoscale level. The ISO technical committee is currently working on these gaps, and intends to develop standards that will improve safety and support responsible development of nanotechnology. Initial areas of standardization development will be terminology, nomenclature, metrology, test methods, health, safety, and the environment.
Archived Copy: hatto_479_7949.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: Pesticide Issues in the Works: Nanotechnology, the Science of Small
Report ID: 461
Date: 1/1/2009
Report Type: Webpage
URL: [nanotechnology.htm]
Country: United States of America
Summary: The EPA's current rule on regulating nanotechnology as pesticides only requires licensing under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) if the nanomaterial is intended to control pests. Nanoscale silver products are particularly popular for claiming antimicrobial properties. Any product containing silver (or any other substance) in any form which claims to control pests must be evaluated and registered prior to its distribution or sale. When companies have failed to do so (see report IDs 194 and 383), the EPA has taken action under the FIFRA. The EPA has received a petition (see report ID 149) asking that it regulate all products containing nanoscale silver as pesticides under the FIFRA. While the EPA is considering this petition, it suggests that companies planning to use nanoscale materials as pesticides contact the EPA's pesticide registration Ombudsmen and provide information on how the pesticide is made, how it is proposed to be used, and how people and the environment may be exposed to the product.
Archived Copy: pesticides_461_6355.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: Nanotechnology Safety Act of 2010
Report ID: 454
Date: 1/21/2010
Author: Mark Pryor, D-AR
Report Type: Proposed Legislation
URL: [legislation.111s2942]
Country: United States of America
Organization: United States Senate
Summary: Senator Mark Pryor introduced this bill, the Nanotechnology Safety Act of 2010, in the 111th Congress. The bill requires, within 180 days of its enactment, the Secretary of Health and Human Services to establish an FDA program to investigate nanomaterials in FDA-regulated products. This investigation will evaluate the potential toxicology of nanomaterials, the effects of nanoparticles on biological systems, and the interaction of nanomaterials with biological systems. The bill also calls for the FDA to share data with other national and international activities and to carry out any other activities necessary and consistent with the purpose of the legislation. Execution of this mandate would be carried out by a newly designated program manager, and the Secretary of Health and Human Services would report to Senate committees in 2012 and 2014 on the short and long term goals of the program, an assessment of funding levels, and a review of the coordination of activities under the program with other departments participating in the National Nanotechnology Initiative (NNI). The bill appropriates $25 million in each fiscal year 2011-2015 for this program. As of June 2010, this bill remains in committee.
Archived Copy: S.2942_454_7789.pdf



Report Title: Nanomaterials Information Call-In
Report ID: 453
Date: 1/22/2010
Report Type: Webpage
URL: [nanocallin.cfm]
Country: United States of America
Organization: California Department of Toxic Substances Control (DTSC)
Summary: In January 2009, the California Department of Toxic Substances Control (DTSC) initiated its chemical information call-in for carbon nanotubes (see report ID 100). January 22, 2010 was the deadline for manufacturers and importers of carbon nanotubes to respond to DTSC's request for toxicity data and other information. Eighteen of twenty-six companies responded. Responses received are published on this website. Most respondents say that they followed standard laboratory practices and NIOSH's nanomaterial safety guidelines. One, Stanford University, has implemented specific nanomaterial safety measures and treats waste containing carbon nanotubes as hazardous.
Archived Copy: nanocallin_453_7273.pdf



Report Title: Human & Environmental Exposure Assessment of Nanomaterials Workshop
Report ID: 449
Date: 2/24/2009
Report Type: Webpage
URL: [index.html]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: As part of the National Nanotechnology Initiative (NNI), the National Institute for Occupational Safety and Health (NIOSH) and other NNI members organized a workshop to explore the current progress of research on human and environmental exposure to nanomaterials. The workshop was held on February 24-25, 2009, and focused on five priorities: Characterizing exposure among workers; identifying population groups and environments exposed to engineered nanoscale materials; characterizing exposure to the general population from industrial processes, industrial and commercial materials, and consumer products containing nanomaterials; characterizing the health of exposed populations and environments; and understanding workplace processes and factors that determine exposure to nanomaterials. NIOSH will use the information gathered at the workshop for research planning and closing critical research gaps.
Archived Copy: exposureassessment_449_3888.pdf



Report Title: Nanotechnology, Biotechnology, and Information Technology: Implications for Future Science at EPA
Report ID: 447
Date: 6/1/2005
Report Type: Workshop Report
URL: [3c26721f6b9c6e7a852570b30077d1b5!OpenDocument]
Country: United States of America
Organization: EPA, Science Advisory Board
Summary: The EPA's Science Advisory Board held a workshop in June 2005 to educate and inform itself on science and research needs in the areas of nanotechnology, biotechnology, and information technology. This document contains a report of the workshop, including summaries of the keynote speakers and their presentations. Key points in the area of nanotechnology were that systematic life cycle assessments of benefits/risks have yet to be conducted, toxicity information is unknown, and while the precautionary approach suggests a moratorium on certain nanotechnology applications, because nanoparticles are likely to be made at point of use, arguments for a moratorium are irrelevant.
Archived Copy: EPA-SAB-WKS-05-001_447_2703.pdf



Report Title: Chemical Information Call-in Program Bulletin
Report ID: 445
Date: 3/1/2009
Report Type: Bulletin
URL: [P2_FS_Chem-Call-In.pdf]
Country: United States of America
Organization: California Department of Toxic Substances Control (DTSC)
Summary: In 2008, the DTSC began a chemical information call-in for carbon nanotubes (see report ID 100). Information was collected on analytical test methods, fate and transport in the environment, and other relevant information from carbon nanotube manufacturers. Pursuant to its previously announced interest in doing so, the DTSC is now expanding the call-in to other chemical classes. This bulletin announces that Bis(2-ethylhexyl) tetrabromophtlate (TBPH) and decamethylcyclopentasiloxane (D5), chosen because of their high production volume and widespread usage, are the subjects of a new call-in. The call-in process will identify available information on these chemicals, potential data gaps, information addressing potential data gaps, other specific information, and new information that may be required to ensure these chemicals can be used safely.
Archived Copy: P2_FS_Chem-Call-In_445_5326.pdf



Report Title: Nanotechnology
Report ID: 444
Date: 2/20/2009
Report Type: Webpage
URL: [index.cfm]
Country: United States of America
Organization: California Department of Toxic Substances Control (DTSC)
Summary: The California Department of Toxic Substances Control (DTSC)'s website contains a summary of nanotechnology, the DTSC's reasons for its interest in nanotechnology safety, and current events in California nanotechnology regulation. Previously (see report ID 100), the DTSC had held a chemical information call-in for carbon nanotubes. At that time, the website announced the DTSC's intent to request information regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes. As of June 2010, the website contains links to California nanotechnology reports and the DTSC's chemical information call-ins.
Archived Copy: DTSC_444_3013.pdf



Report Title: P-08-0177: Consent Order and Determinations Supporting Consent Order
Report ID: 436
Date: 8/1/2008
Author: EPA, Office of Pollution Prevention and Toxics
Report Type: Administrative Order
Publication: US EPA OPPT Docket No. P-08-0177
Country: United States of America
Organization: EPA, Office of Pollution Prevention and Toxics (US Government)
Summary: Admistrative Order on Consent, issued by US EPA Under the authority of §5(e) of the Toxic Substances Control Act ('TSCA") (15 U.S.C.2604(e)) issued to the importer of certain "multiwalled carbon nano tubes" "MWCNT". It does not apply to all MWCNT. The Order was issued in connection with the Agency's review of premanufacture notice ("PMN") P-08-0177 for the substance by the importer. One is required by §5 of TSCA to subhmit a PMN to USEPA no less than 90 days prior to importing or manufacturing a "new" chemical substance -- one not listed on the TSCA Inventory of chemical substances in commerce. 40 CFR Part 720.

The AOC requires the Importer to: (1) conduct a 90-day inhalation toxicity study in rats with a post exposure observation period of up to 3 months including ("BALF") analysis before manufacturing or importing more than a specified amount of the material; (2) to use gloves impervious to nanoscale particles and chemical protective clothing; (3) to require workers to use a NIOSH-approved full-face respirator with an N -100 cartridge while exposed by inhalation in the work area; (4) to use the PMN substance only as a property modifier in electronic applications or in polymer composites; and (5) to distribute the PMN substance only to persons who agree to follow the same restrictions (except the testing requirements).

The Order was modified in August 2009 to prohibit
Archived Copy: EPA-HQ-OPPT-2008-0252-0022 MWCNT AOC_436_9286.pdf



Report Title: Nanomaterial Research Strategy
Report ID: 435
Date: 6/1/2009
Author: Jeff Morris and Randy Wenstel, et. al.
Report Type: Advisory Report
URL: [nanotech_research_strategy_final.pdf]
Country: United States of America
Organization: EPA. Office of Research and Development
Summary: The Nanomaterial Research Strategy is designed to guide the EPA’s Office of Research and Development’s program in nanomaterial research. The strategy builds on and is consistent with the foundation of scientific needs identified by the Nanotechnology Environmental and Health Implications Working Group (NSTC, 2008), and in the EPA’s Nanotechnology White Paper (EPA, 2007). Put succinetly, the EPA’s Nanomaterial Research Program is designed to provide information through focused research to support nanomaterial safety decisions in conjunction with the various environmental statutes for which EPA is responsible.
Archived Copy: nanotech_research_strategy_final_435_3312.pdf



Report Title: Joint US – UK Research Program: Environmental Behavior, Bioavailability and Effects of Manufactured Nanomaterials
Report ID: 434
Date: 3/31/2009
Report Type: Notice
Publication: Catalog of Federal Domestic Assistance
URL: [2009_uk_nano.html]
Country: United States of America
Organization: EPA, National Center for Environmental Research
Summary: The U.S. Environmental Protection Agency, as part of its Science to Achieve Results (STAR) program, in conjunction with the U.K. Environmental Nanoscience Initiative, is seeking joint applications from U.S. and U.K. partners. These applications should: propose integrated model(s) of fate, behavior, bioavailability and effects for several important and representative nanomaterial classes over key environmental pathways using intrinsic material properties and life cycle analysis as a starting point for model development; validate and refine these model(s) through interdisciplinary research, addressing key assumptions and areas of uncertainty; and develop effective methods and tools to detect, assess, and monitor the presence of nanomaterials in biological and environmental samples. Two consortia, made up of U.K. and U.S. research institutions, will be selected for funding amounting to approximately $4 million for U.S. applicants and £3 million for U.K. applicants.



Report Title: Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials
Report ID: 433
Date: 3/1/2009
Author: Christine M. Branche, et. al.
Report Type: Government Report
URL: [2009-125.pdf]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: In order to protect worker safety, the National In¬stitute for Occupational Safety and Health (NIOSH) released for public comment the draft document, “Approaches to Safe Nanotechnology: An Information Exchange with NIOSH” in October 2005. Based on feedback received, NIOSH revised and updated the document and sought further public com¬ment before releasing the final version of this document, which provides an overview of what is known about the potential hazards of engineered nanoparticles and measures that can be taken to minimize workplace exposures. It should serve as a vital resource for stakeholders (including occupational safety and health professionals, researchers, policy makers, risk assessors, and workers in the industry) who wish to understand more about the safety and health implications of nanotechnology in the workplace.
Archived Copy: 2009-125_433_4611.pdf



Report Title: Progress Toward Safe Nanotechnology in the Workplace
Report ID: 432
Date: 11/1/2009
Author: John Howard, et al
Report Type: Background Document
URL: [2010-104.pdf]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations to prevent work-related injury, illness, and death. As mandated by the Occupational Safety and Health Act, the NIOSH established the Nanotechnology Research Center (NTRC) in 2004 to coordinate and promote research in nanotechnology and to develop guidance on the safe handling of nanomaterials in the workplace. In February 2007, NIOSH issued its report on “Progress Toward Safe Nanotechnology in the Workplace,” describing the progress of the NTRC since its inception in 2004 through 2006. This November 2009 update describes program accomplishments achieved in 2007 and 2008, and it includes summary updates from forty-three intramural projects and a comprehensive extramural program. The NTRC research program has identified ten critical topic areas for understanding the potential health risks and developing and disseminating recommendations, many of which correspond with the National Nanotechnology Initiative Strategy for Nanotechnology Environmental Health and Safety Research.
Archived Copy: 2010-104_432_5920.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: Environment, Safety and Occupational Health (esoh) Risks from Engineered Nanomaterials
Report ID: 382
Date: 5/13/2008
Author: John J. Young Jr.
Report Type: Memo
URL: [Signed%202008%20Nano%20policy%20for%20DoD%202.....]
Country: United States of America
Organization: Department of Defense
Summary: This memorandum reinforces responsibilities and provides information for managing
ESOH risks of engineered nanomaterials in DoD research, acquisition, operations, and support. Environment, Safety and Occupational Health (ESOH) professionals and program managers should exercise diligence in meeting their responsibilities to protect the health and safety of workers and the public by ensuring that ESOH hazards are identified and the associated risks managed pursuant to DoDI 5000.2, Military Standard 882D, and other DoD policy requirements. Since no current standard exists to fully evaluate ESOH risks, S&T managers should support ESOH risk research to close information gaps in developmental efforts using nanomaterials. Additionally, they should keep abreast of current knowledge of ESOH risks for engineered nanomaterials and provide S&'r managers, PMs, and users with ESOH risk management options required by DoDI 6055.5. As information relevant to emerging nanomaterials risk science and policy issues becomes available, it will be posted at the Defense ESOH Information Exchange site (www.DENIX/osd.mil under the MERIT working group.
Archived Copy: DoD ESOH Risks Memo_382_3271.pdf



Report Title: Summary Minutes of the Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Report ID: 212
Date: 7/22/2008
Author: US Food and Drug Administration (FDA)
Report Type: Meeting Minutes
URL: [2008-4370m1-Final%20Minutes.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: This document is the summary minutes for the July 22, 2008 meeting of the FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. The first topic at this meeting was nanotechnology in drug manufacturing, drug delivery, and drug products. The committee was evenly divided on whether the Committee for Drug Evaluation and Research (CDER) needed to provide guidance for the development of nanotechnology derived drug applications. Members felt that insufficient information about nanotechnology drug products existed to be able to provide guidance at the present time. If guidance was needed, a consensus existed that it would need to focus on the unique characteristics of such compounds, biodistribution, how safety may be different than that of traditional drug products, and environmental consequences. The committee also found that a definition of nanotechnology (for defining which products need guidance) should be based upon intended and unintended functionality of the drug, the differences between altering existing products and creating new materials, and changes which may occur if an existing production process is altered.
Archived Copy: FDA Advisory committee 2008-4370m1-Final Minutes_212_1645.pdf



Report Title: External Review Draft, Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen
Report ID: 210
Date: 7/1/2009
Author: EPA, National Center for Environmental Assessment
Report Type: Study
URL: [eimscomm.getfile]
Country: United States of America
Organization: EPA, National Center for Environmental Assessment
Summary: This draft study of two specific nanotechnology applications, titanium dioxide in water treatment and topical sunscreen, is intended to be a foundation for the development of “scientific and technical information needed for future assessment efforts.” The EPA encourages readers to comment on specific “knowledge gaps” which exist in this draft, and to offer suggestions as to how these gaps may be better addressed in the future. The comprehensive environmental assessment (CEA) approach taken in this document combines a life-cycle framework with a risk assessment paradigm, examining the direct and indirect effects of titanium dioxide throughout a product’s life cycle, including disposal. In order, the study examines the stages of the life cycle in question, fate and transport processes, exposure-dose characterization, and ecological and health effects. This document is not intended to provide an actual CEA of titanium dioxide, but only to identify which information is known and needs to be known to conduct an comprehensive assessment of similar nanomaterials in the future.
Archived Copy: EPA_NANOMATERIAL_CASE_STUDIES_ERD[1]_210_3052.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: CPSC Nanomaterial Statement
Report ID: 193
Date: 1/1/2005
Author: Consumer Product Safety Commission (CPSC)
Report Type: Statement
URL: [cpscnanostatement.pdf]
Country: United States of America
Organization: Consumer Product Safety Commission (CPSC)
Summary: The US Consumer Product Safety Commission (CPSC) released this brief statement regarding the safety of nanomaterial-containing products. Pre-market registration is not required, and the CPSC cannot evaluate public risk until a product is introduced for sale. Because there are no nanotechnology-specific regulations, the CPSC will examine nanotech products using the same criteria applied to all other consumer products, checking for defects causing substantial risk of injury to the public. Responsibility is on manufacturers to ensure that their products are safe, and any information to the contrary must be reported to the CPSC. Chronic health effects, a larger concern of nanomaterials, are examined in a similar fashion. The CPSCs chronic hazard guidelines, in conjunction with the Federal Hazardous Substances Act (FHSA), are used in determining whether a product has the potential to cause substantial personal injury or substantial illness. At present, the CPSC is reviewing and updating its guidelines to address the usage of nanomaterials in consumer products.
Archived Copy: CPSCNanostatement_193_6364.pdf



Report Title: Nanotechnology under the Toxic Substances Control Act
Report ID: 181
Date: 1/12/2009
Author: Environmenatl Protection Agency
Report Type: Webpage
URL: [Default.htm]
Country: United States of America
Summary: This brief webpage summarizes the Toxic Substances Control Act (TSCA). The TSCA requires that manufacturers of new chemical substances submit safety information to the EPA before such substances can be manufactured or sold. The Act permits the EPA to require additional information on currently manufactured substances, as well as the license to control substances which may pose unacceptable environmental or health risks. This document contains links to supporting white papers and guidance documents for ascertaining whether nanomaterial versions of existing chemical substances are new substances or are already listed on the TSCA Inventory. The second section of this document describes international cooperation in nanotechnology and provides links to the appropriate ISO technical committee and the OECDs Working Party on Manufactured Nanomaterials.
Archived Copy: Michael Vincent EPA (2009), Nanotechnology under the TSCA_181_9884.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: Principles for Nanotechnology Environmental, Health, and Safety Oversight
Report ID: 173
Date: 11/8/2007
Author: John H. Marburger III, Director, Office of Science and Technology Policy and James L. Connaughton, Chairman, Council on Environmental Quality
Report Type: Memo
URL: [Nano%20EHS%20Principles%20Memo_OSTP-CEQ_FINAL.pdf]
Country: United States of America
Summary: This memo, distributed to the heads of US government executive departments and agencies, summarizes principles for environmental, health, and safety oversight of nanotechnology. The purpose of these principles is to protect human health and the environment while not foreclosing the benefits of nanotechnology. Current statutory authorities are believed adequate to regulate nanotechnology. These authorities should be supplied with appropriate regulation to protect safety where regulation is needed and where scientific research supports protection, rather than a broad approach. These regulations should when possible promote innovation rather than stifle it, and should justify their costs. The memo lists existing regulations and guidance which should be considered when developing new regulations.
Archived Copy: Michael Vincent (OSTP) 2007, Principles for Oversight_173_4135.pdf



Report Title: Notice of Public Meeting and Availability for Public Comment
Report ID: 172
Date: 12/12/2007
Author: NIOSH
Report Type: Notice
URL: [PDFgate.cgi]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: This document from December 12, 2007 gives notice of a public meeting and request for comment period on a draft Current Intelligence Bulletin (CIB) Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles. The public comment period was December 14, 2007 through February 15, 2008. The public meeting was held on January 30, 2008. The CIB is a guidance document without force of law which recommends that employers identify the presence of engineered nanoparticles in the workplace and take action to prevent employee exposure. Persons wishing to attend the meeting must submit notification of intent by January 18, 2008 and may be provided up to twenty minutes for oral comments.
Archived Copy: Michael Vincent (NIOSH) 2007, Notice of Public Meeting_172_3715.pdf



Report Title: Recommendations for a Municipal Health & Safety Policy for Nanomaterials, a Report to the Cambridge City Manager
Report ID: 171
Date: 7/1/2008
Author: Cambridge Nanomaterials Advisory Committee
Report Type: Municipal report
URL: [July_17_08_Nano_Recommendations.pdf]
Country: United States of America
Organization: Cambridge Public Health Department
Summary: After the passage of a nanotechnology ordinance for Berkeley, California, the Cambridge Public Health Department reviewed at the City Managers request the possibility of a similar ordinance in the city of Cambridge, Massachusetts. A Cambridge Nanomaterials Advisory Committee was convened. This report contains the recommendations of the Committee. Because of the limited health data and standards currently available for nanomaterials, the Committee recommended against the enacting of a city ordinance. However, its recommendations included the creation of an inventory for nanomaterial facilities, the sponsoring of public outreach events, and biannual reporting to the City Council as regulations and data develop.
Archived Copy: Michael Vincent_US cambrdige July_17_08_Nano_Recommendations_171_1627.pdf



Report Title: Citizen Petition for Rulemaking Requesting EPA Regulation Nano-Silver Products as Pesticides
Report ID: 149
Date: 5/1/2008
Author: Stephen L. Johnson
Report Type: Petition
URL: [CTA_nano-silver%20petition__final_5_1_08.pdf]
Country: United States of America
Organization: International Center for Technology Assessment
Summary: The petition put forth by the International Center for Technology Assessment and other allied groups requests that the Environmental Protection Agency (EPA) classify nanoscale silver as a pesticide, require formal pesticide registration of all products containing nanoscale silver and investigate the effects on human health and environmental risks of nanoscale silver. Most of these requested actions do not require a rulemaking by EPA; instead, petitioners desire for clearer notice and guidance from the agency, especially in light of the regulatory actions involving silver ion washing machines and nano-silver electronics. However, these efforts should also include regulatory actions under the Federal Insecticide, Fungicide, and Rodenticide Act against existing products that contain nanoscale silver in addition to other regulatory efforts through statutes including the Food Quality Protection Act, Endangered Species Act, and National Environmental Policy Act.
Archived Copy: CTA_nano-silver petition__final_5_1_08_149_4551.pdf



Report Title: Approach to Nanomaterial ES&H, Revision 2
Report ID: 133
Date: 6/1/2007
Author: US Department of Energy
Report Type: Guidance Document
URL: [DOE_NSRC_Approach_to_Nanomaterial_ESH.pdf]
Country: United States of America
Organization: Department of Energy, Nanoscale Science Research Centers
Summary: The US Department of Energys Office of Science funds nanotechnology research at its Nanoscale Science Research Centers (NSRCs) under the Basic Energy Sciences program. This document provides non-mandatory guidance for managing nanoparticle environmental, safety, and health concerns at NSRCs. It is intended to assist NSRCs in protecting worker safety and the environment, promote a consistent policy across offices, and offer reasonable guidance for managing the still-uncertain hazards of nanomaterials. The document discusses controls for laboratory operations, methods of verifying policy effectiveness, transportation guidelines, management of nanomaterial-bearing waste streams, and management of spills. A sample industrial hygiene sampling protocol is attached.



Report Title: Carbon Nanotube Biography
Report ID: 131
Date: 8/20/2008
Author: California Department of Toxic Substances Control
Report Type: Bibliography
Publication: California Carbon Nanotube Biography
Country: United States of America
Organization: California Department of Toxic Substances Control (DTSC)
Summary: This document, published by the California Department of Toxic Substances Control, is a bibliography of carbon nanotube-related sources. It lists databases and academic papers, with the papers organized by topics of analytical methods, bioconcentration, transport, chemical/physical properties, human health effects, environmental effects, and regulation.



Report Title: NIOSH Nanotechnology Field Research Effort
Report ID: 116
Date: 2/1/2008
Report Type: Report of Upcoming Study
Publication: n/a
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: This document previews an upcoming study by the National Institute for Occupational Safety and Health (NIOSH). It stated that NIOSH had created a field research team to assess workplace processes, materials, and control technologies associated with nanotechnology and conduct on-site assessments of potential occupational exposure to a variety of nanomaterials. Furthermore, the document stated the study sought to gather baseline data to assist in determining potential occupational safety and health implications of exposure to engineered nanomaterials and developing guidance to ensure safe working conditions. It also indicated that research laboratories, producers, and manufacturers working with engineered nanomaterials (1 to 100nm) were invited and encouraged to collaborate with NIOSH. Finally, the document reported that the research data would be used by NIOSH to update its guidance on occupational safety and health implications of exposure to nanomaterials, and it would be made available in technical documents, scientific presentations, or on the NIOSH website.



Report Title: Nanotechnology Metal Oxide Particle Exposure Assessment Study
Report ID: 114
Date: 4/1/2008
Report Type: Preview to a Study
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: The document previews an upcoming study by the National Institute for Occupational Safety and Health (NIOSH) that will investigate exposure to fine (0.1µm to 2.5µm diameter) and ultrafine (<0.1µm diameter) metal oxides. The purpose of the metal oxide study is to measure and characterize workplace exposure to fine and ultrafine metal oxides in both manufacturing and end-user facilities. The document stated that results from the study would allow NIOSH to determine which processes and job tasks pose the highest risk of exposure to workers, and develop effective ap¬proaches to reduce occupational health and safety risks from exposure to nano¬materials. Furthermore, the document added that the study was only to conduct a detailed evaluation of exposures to fine and ultrafine metal oxides, and was not the same as the baseline assessment program offered by the NIOSH nanotechnology field research team. Additionally, the document stated that workers at facilities that manufacture and use fine and ultrafine metal oxides are being asked to participate in the study. Finally, it projected that sample results could help companies develop a better understanding of metal oxide exposure occurring in their facility by identifying areas of contamination and giving recommendations to reduce exposure when possible.



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: Consideration of FDA-Regulated Products That May Contain Nanoscale Materials
Report ID: 107
Date: 8/7/2008
Report Type: Notice
URL: [FDA-2008-M-0416-nm.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: The Food and Drug Administration (FDA) is announcing a public meeting and a request for comments including available data to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report (the Report) relating to the development of agency guidance. The Report's recommendations covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. In addition to requesting comments in response to the questions in this notice and those that will be discussed at the public meeting, FDA is announcing a request for available data and information on the effects of nanoscale materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight.



Report Title: Certain New Chemicals; Receipt and Status Information
Report ID: 106
Date: 12/1/2008
Author: Chandler Sirmons, Acting Director, Information Management Division, Office of Pollution Prevention and Toxics
Report Type: Notice
Publication: Federal Registar, vol. 73, No. 240, December 12, 2008
Country: United States of America
Organization: U.S. Environmental Protection Agency
Summary: In this report, the Environmental Protection Agency (EPA) stated that Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. The EPA added that under sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME). It also must publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from November 3, 2008 through November 14, 2008, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this period.



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.



Report Title: Chemical Information Call-In Carbon Nanotubes
Report ID: 100
Date: 1/22/2009
Author: Jeffrey Wong, Chief Scientist, DTSC
Report Type: Letter of Inquiry
URL: [Formal_AB289_Call_In_Letter_CNTs.pdf]
Country: United States of America
Organization: California Department of Toxic Substances Control (DTSC)
Summary: This letter of inquiry serves to announce that the DTSC is requesting information regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes (CNT). Considering their commercial use, lack of data, and recent research on the potential impacts to the environment, workers and the public, the DTSC is implementing this chemical call-in program in order to better protect human health and the environment. Currently, the list includes academic institutions conducting CNT research and those manufacturers who are involved in producing or importing CNT in their chemical form. Although manufacturers who import products containing CNTs have not been included, the list may expand in the future to include product manufacturers. The DTSC will then evaluate this information and build a public record of compliance, with the caveat that trade secret protections can be exercised by the DTSC upon request. A research bibliography will be posted on the DTSC web site which will be updated periodically with the intent that the information will be utilized to support sound science and safety in chemical practices by regulatory agencies, manufacturers, researchers, product developers, and consumers.



Report Title: Nanoscale Materials Stewardship Program: Interim Report, January 2009
Report ID: 89
Date: 1/1/2009
Author: Environmental Protection Agency
Report Type: Government Report
URL: [nmsp-interim-report-final.pdf]
Country: United States of America
Organization: EPA, Office of Pollution Prevention and Toxics (US Government)
Summary: The Nanoscale Materials Stewardship Program (NMSP) is a voluntary program for the reporting of available information regarding engineered nanoscale materials. This document is an interim report describing the progress and effectiveness of the NMSP thus far. It describes the types of data made available to the EPA through members in the Program and its role in shaping future legislation. Most data collected thus far has concerned physical properties, use, and manufacturing processes. Voluntary reporting of toxicity and other human risk factors has been low, however the NMSP has effectively informed the EPA about the structure of reporting information on nanoscale materials and of policy issues that must be addressed.



Report Title: Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials
Report ID: 88
Date: 4/1/2009
Report Type: Government Report
URL: [Default.htm]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: This document provides an overview of the current knowledge regarding potential hazards of engineered nanomaterials and measures for minimizing workplace exposures. It reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. This updated version of the document incorporates some of the latest results of NIOSH research, but it is only a starting point. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops.



Report Title: TSCA Inventory Status of Nanoscale Substances—General Approach
Report ID: 80
Date: 1/1/2008
Report Type: General Report
Country: United States of America
Organization: U.S. Environmental Protection Agency
Summary: In response to the rapid development of nanotechnology and introduction of nanoscale substances, the EPA issued this report stating it will maintain its previous evaluation process to determine whether nanomaterials are new chemicals. The EPA currently determines whether a substance is a “new” chemical according to the Toxic Substances Control Act (“TSCA”) by determining whether it has the same molecular identity as a substance already in the TSCA Inventory. If the chemical substance does not have an identical molecular identity to a substance on the TSCA Inventory, then it is considered a new chemical substance. The EPA considers chemical substances to have different molecular identities when they have any of the following: different molecular formulas, the same molecular formulas but have different atom connectivities, the same molecular formulas and atom connectivities but have different spatial arrangements of atoms, the same types of atoms but have different crystal lattices, different isotopes of the same elements, or are different allotropes of the same element. The EPA added that systematic chemical nomenclature conventions may not exist for all nanoscale substances identified as new chemicals, but the EPA is working on developing appropriate nomenclature conventions to meet these needs. Furthermore, any substance determined to be a “new” chemical is subject to the TSCA regulations before it may be manufactured or imported. However, the EPA may use different approaches when making regulatory stats determinations under its other authorities (e.g., the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)). However, in adopting this approach under TSCA, the EPA is not establishing a precedent on how nanotechnology issues arising under other EPA programs, other Federal Government agencies, or other federal statutes will be addressed. The EPA encouraged manufacturers and importers to contact the New Chemicals to program to determine whether their nanoscale substance is a new chemical. To help promote nanotechnology research, Italy has created four technology districts (TD) under the direction of the Association of Technology Districts (ADITE) in 2006. ADITE, along with various other public organizations, is working to increase funding opportunities and build up effective collaborations. Ecoffier concludes that these collaborations between public and private sectors have helped overcome the biggest hurdles in Italy's nanotechnology research and should be encouraged in the future. Finally, Ecoffier suggests that Italy's must increase their national initiative in order to better advance the country's nanotechnology research.



Report Title: Review of Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research
Report ID: 73
Date: 1/1/2008
Report Type: Committee Report
URL: [catalog.php]
Country: United States of America
Organization: Committee on Toxicology, National Research Council
Summary: As part of the US National Nanotechnology Initiative, the National Research Council was asked to conduct a scientific and technical review of the National Nanotechnology Coordination Office's report, “Strategy for Nanotechnology-Related Environmental, Health, and Safety Research.” The Council considered the elements of an effective nanotechnology risk research strategy, whether the federal strategy contained those elements, and whether the appropriate research is underway to meet risk identification and management needs. This document contains the Council's review findings, which identify nine areas of a successful risk research strategy: Vision, goals, evaluation of the state of science, road map, evaluation, review, resources, mechanisms, and accountability. The Council found the federal strategy to be lacking in vision, goals, and a plan of action for achieving those goals.



Report Title: Interim Guidance for Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles
Report ID: 67
Date: 2/1/2009
Report Type: Bulletin
URL: [Default.htm]
Country: United States of America
Organization: National Institute for Occupational Safety and Health (NIOSH)
Summary: Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposure to engineered nanoparticles is quite small. While there is increasing evidence to indicate that exposure to some engineered nanoparticles can cause adverse health effects in laboratory animals, no health studies of workers exposed to the few engineered nanoparticles tested in animals have been published. The purpose of this document from the National Institute for Occupational Safety and Health (NIOSH) is to provide interim guidance about whether specific medical screening, including performing medical tests on asymptomatic workers, is appropriate for these workers. This document concludes that there is currently (as of February 2009), insufficient scientific and medical evidence to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles. However, workplaces are recommended to take prudent measures to control exposures, conduct hazard surveillance, and continue using established medical surveillance approaches.



 
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