The Finnish Institute of Occupational Health released a report in October 2013 entitled Evaluation of the health effects of carbon nanotubes. According to the Institute, recent studies have suggested that some types of multiwalled carbon nanotubes (MWCNT) have similar effects as asbestos. The Institute states that the report “shows that rigid, long and needle-like MWCNTs induce inflammation and DNA damage in the lungs and in cultured cells, while flexible, long and tangled MWCNTs do not. It appears that the rigidity of MWCNTs is a key feature in triggering a specific inflammatory reaction and in causing cellular alterations involved in cancer formation.” The Institute states that this new information on the adverse effects of MWCNTs will be useful in assessing which forms of MWCNTs require regulatory attention and special safety measures in occupational settings.
Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. The Technology Research Association for Single Wall CNTs (TASC), a consortium of nine companies and AIST, prepared the guidance, which is intended to provide a means of CNT safety management. The guidance summarizes the available practical methods for measuring airborne CNTs: (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. The guidance also presents measurement cases performed by TASC. TASC developed the guidance under the project “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO). The guidance notes that a specific method has not yet been definitively determined, and many challenges still remain.
On November 8, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes, which identifies and describes strategies for the engineering control of worker exposure during the production or use of engineered nanomaterials. NIOSH notes that there are currently more than 1,000 nanomaterial-containing consumer products available, including “makeup, sunscreen, food storage products, appliances, clothing, electronics, computers, sporting goods, and coatings.” According to the report, hazards involved in manufacturing and processing nanomaterials “should be managed as part of a comprehensive occupational safety, health, and environmental management plan.” NIOSH states: “Engineering controls are favored over administrative controls and personal protective equipment for lowering worker exposures, because they are designed to remove the hazard at the source, before it comes into contact with the worker.” The report includes specific conclusions and recommendations on the following topics: general; control banding; hierarchy of controls; engineering controls; administrative controls; and personal protective equipment.
On October 21, 2013, Particle and Fibre Toxicology posted an article entitled “Carbon nanotube dosimetry: from workplace exposure assessment to inhalation toxicology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), note that there are currently no known end-point effects in humans following carbon nanotube (CNT) exposure, leading to extrapolation from rodent studies. The purpose of the study was to determine how realistic U.S. workplace exposures to CNTs relate to animal studies. The study states that its goal “was to expose animals to a high dose that would cause significant inflammation with histological findings and then a low dose to serve as a no observable effect level. This design will serve as a reference for detailed molecular analysis, pulmonary pathology, systemic inflammation, and evaluation of cardiovascular dysfunction at human relevant exposures.” The abstract states that the findings “showed a limited pulmonary inflammatory potential of MWCNT at levels corresponding to the average inhalable elemental carbon concentrations observed in U.S.-based CNT facilities and estimates suggest considerable years of exposure are necessary for significant pathology to occur at that level.” The conclusion itself states: “It is clear from toxicological evaluations that MWCNT have a relatively high hazard when compared to other materials. These hazards may include fibrosis, promotion of lung tumors, cardiovascular dysfunction, and pulmonary and systemic inflammation. The present findings show that limiting cumulative exposures is imperative to reducing adverse effects.”
The Air & Waste Management Association (A&WMA) recently announced the formation of an Intercommittee Task Force (ITF) on Nanoscale Science and Engineering. The ITF will span a wide array of subjects, including environmental policy, measurement, health effects, monitoring, management, and safety issues associated with the development and use of nanomaterials, nanotechnologies, and nanoscale products. Its objectives will likely be:
- To bring societal recognition, understanding, and emphasis to address rapidly developing environmental health and safety issues associated with the development and use of nanomaterials;
- To provide coordination and focus among A&WMA’s Technical Coordinating Committees (TCC) to address specific issues posed by the development and use of nanomaterials; and
- To provide leadership, a forum, and opportunity to members, regulatory agencies, industry, and the public to assess scientific, technical, and policy issues relevant to the development and use of nanomaterials.
Full participation in the ITF is typically available only to A&WMA members. The ITF is aware that members of other organizations may wish to participate, or that potential participants may be unsure whether they wish to join A&WMA at this time. Therefore, the ITF is open to non-A&WMA members.
On September 12, 2013, the National Research Council (NRC) released a report entitled Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked the NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). The Committee to Develop a Research Strategy for EHS Aspects of ENMs was formed and released a report in January 2012, A Research Strategy for the Environmental, Health, and Safety Aspects of Engineered Nanomaterials. That report developed a research plan with short- and long-term priorities and estimated resources needed to implement the research plan. In the 2013 report, the Committee assesses the trajectory of research progress on the basis of indicators identified in its first report. According to the report, while some progress has been made in advancing the research agenda on the EHS aspects of ENMs, little work has been done to implement an integrated research strategy throughout the federal government. The Committee reiterates a conclusion from the first report, that accountability for implementing a research strategy “is hampered by the absence of an entity with sufficient management and budgetary authority to direct research efforts governmentwide.” The Committee “maintains that [the National Nanotechnology Initiative (NNI)] would benefit from a clearer separation of authority and accountability for its environmental, health, and safety research enterprise in relation to its mandate to promote nanotechnology development and commercialization.” The report suggests “progress could be accelerated if a single agency with sufficient management and budgetary authority was designated to direct” EHS research efforts and ensure implementation of a coordinated plan among the federal agencies that make up the NNI.
On April 15, 2013, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) and NanoQuébec announced they will jointly fund three new research projects on worker exposure to engineered nanoparticles. The principal researchers for these projects, their affiliations, and the titles of the projects selected are:
- Nathalie Tufenkji, McGill University, “Measuring the Effectiveness of Protective Gloves for Working with Nanoparticles in Conditions Simulating their Use in the Workplace”;
- Maximilian Debia, Université de Montréal, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces”; and
- Karim Maghni, Université de Montréal, “The Development and Validation of Universal NanoBadge prototypes (u-Nanobadge) for Evaluating Pulmonary and Cutaneous Exposure to Engineered Nanoparticles.”
According to IRSST, the projects will likely take two years to complete and will involve collaborators from various institutions, as well as students.
An April 26, 2013, USA Today article entitled “CDC sets carbon nanotech safety guidelines” reports on the National Institute of Occupational Safety and Health (NIOSH) Current Intelligence Bulletin (CIB) 65, Occupational Exposure to Carbon Nanotubes and Nanofibers. The article includes comments from Andrew Maynard, Chair of Environmental Health Sciences at the University of Michigan, Todd Kuiken with the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars, and Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C. and a board member of the NanoBusiness Commercialization Association.
On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m3) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 μg/m3 but that the analytic limit of quantification was 7 μg/m3.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 μg/m3. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed.
The United Kingdom’s (UK) Health and Safety Executive (HSE) has posted a guidance document describing how to control occupational exposure to manufactured nanomaterials in the workplace. HSE intends the guidance to assist in compliance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH) (as amended). HSE states that the guidance is specifically about the manufacture and manipulation of all manufactured nanomaterials, carbon nanotubes (CNT), and other bio-persistent high aspect ratio nanomaterials (HARN). HSE prepared the guidance “in response to emerging evidence about the toxicity of these materials.” According to HSE, the control principles described in the guidance can be applied to all nanomaterials used in the workplace. HSE highlights any differences in the approach between control of CNTs and other bio-persistent HARNs to other types of nanomaterials.
On March 18, 2013, Safe Work Australia (SWA) released two research reports examining nanotechnology work health and safety issues, Investigating the Emissions of Nanomaterials from Composites and Other Solid Articles During Machining Process and Evaluation of Potential Safety (Physicochemical) Hazards Associated with the Use of Engineered Nanomaterials. SWA noted the perceived safety risks of nanomaterials and that Australia is taking a precautionary approach towards nanomaterials under the National Enabling Technologies Strategy. SWA Chair Ann Sherry stated that while the risk to human health and safety from a number of nanomaterials and applications is low, some nanomaterials, such as carbon nanotubes, are potentially more hazardous. SWA’s press release states: “Minimisation of exposure to nanomaterials at work is essential until there is sufficient data to rule out hazardous properties. Research has shown if conventional engineering controls are designed and maintained effectively, exposure to nanomaterials can be significantly reduced.” According to the press release, as a result of the findings in the research reports, SWA intends to prepare guidance material on combustible dust hazards, including nanomaterials.
On March 11, 2013, the European Union’s (EU) FP7 project on Mitigation of Risk and Control of Exposure in Nanotechnology-based Inks and Pigments (nanoMICEX) announced publication of its first newsletter. According to nanoMICEX, project participants have been working to improve the conditions for workers in the inks and pigments industry, and the newsletter describes the latest news and developments. The newsletter reports on the March 2012 kick-off meeting, where participants discussed which engineered nanoparticles to characterize, how best to carry out hazard and exposure assessments, and ways in which risks will be assessed and managed. The newsletter describes work that has been done to date, while more in-depth articles by nanoMICEX partners provide information on how the partners are ensuring the safety of workers within the industry. The newsletter includes a timeline of upcoming activities in the next six months, including publication of the next newsletter in September 2013.
NIOSH Announces New Findings on Lung Tumor Formation in Laboratory Mice Exposed to Multi-Walled Carbon Nanotubes
On March 11, 2013, at the annual meeting of the Society of Toxicology, researchers from the National Institute for Occupational Safety and Health (NIOSH) reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes (MWCNT). According to NIOSH, the study was designed to investigate whether these tiny particles have potential to initiate or promote cancer. One group of laboratory mice was injected with a chemical that is a known cancer initiator, and another group of mice was injected with a saline solution as a control group. The mice then were exposed by inhalation either to air or to a concentration of MWCNT. According to NIOSH, mice receiving both the initiator chemical plus exposure to MWCNT were significantly more likely to develop tumors and have more tumors than mice receiving the initiator chemical alone. Additionally, mice exposed to MWCNT and to MWCNT plus the initiator chemical had larger tumors than the respective control groups. NIOSH concluded that the results indicate that MWCNT can increase the risk of cancer in mice exposed to a known carcinogen. NIOSH notes that the study does not suggest that MWCNTs alone cause cancer in mice.Continue Reading...
The Occupational Safety and Health Administration (OSHA) recently published a fact sheet entitled Working Safely with Nanomaterials. OSHA notes that workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion. OSHA intends the fact sheet to provide “basic information to workers and employers on the most current understanding of potential hazards associated with this rapidly-developing technology and highlight measures to control exposure to nanomaterials in the workplace.” According to the fact sheet, information and training provided to workers should include:
- Identification of nanomaterials the employer uses and the processes in which they are used;
- Results from any exposure assessments conducted at the work site;
- Identification of engineering and administrative controls and personal protective equipment (PPE) to reduce exposure to nanomaterials;
- The use and limitations of PPE; and
- Emergency measures to take in the event of a nanomaterial spill or release.
OSHA states that there are few occupational exposure limits specific to nanomaterials. According to OSHA, because certain nanoparticles may be more hazardous than larger particles of the same substance, existing occupational exposure limits for a substance may not provide adequate protection from nanoparticles of the same substance. OSHA notes the following specific exposure limits:
- OSHA recommends that worker exposure to respirable carbon nanotubes and carbon nanofibers not exceed 7.0 micrograms per cubic meter (μg/m3) as an 8-hour time-weighted average, based on the National Institute for Occupational Safety and Health (NIOSH) proposed Recommended Exposure Limit (REL); and
- OSHA recommends that worker exposure to nanoscale particles of titanium dioxide (TiO2) not exceed NIOSH’s 0.3 milligrams per cubic meter (mg/m3) REL. By contrast, NIOSH’s REL for fine-sized TiO2 (particle size greater than 100 nm) is 2.4 mg/m3.
OSHA suggests that, because exposure limits for other nanomaterials do not exist yet, employers should minimize worker exposure by using the hazard control measures and best practices identified in the fact sheet and in the references noted.
On January 18, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice seeking comment on the types of hazard identification and risk management research to consider in updating its fiscal years 2013-2016 nanotechnology strategic plan. NIOSH states that it wants to “build on the accomplishments of ongoing research” to “develop strategic research goals and objectives for nanotechnology occupational safety and health research through 2016.” NIOSH previously identified ten critical research areas for nanotechnology research and communication: (1) toxicity and internal dose; (2) measurement methods; (3) exposure assessment; (4) epidemiology and surveillance; (5) risk assessment; (6) engineering controls and personal protective equipment; (7) fire and explosion safety; (8) recommendations and guidance; (9) global collaborations; and (10) applications. According to the notice, NIOSH is considering focusing the research goals on five key objectives: (1) increase understanding of new hazards and related health risks to nanomaterial workers; (2) expand understanding of the initial hazard findings on engineered nanomaterials; (3) support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches; (4) support epidemiologic studies for nanomaterial workers, including medical and exposure studies; and (5) assess and promote national adherence with risk management guidance. NIOSH requests public input to address the basis or rationale for priorities that NIOSH should give for studies of toxicity evaluation and/or workplace exposure characterization for engineered nanoparticles, and what rationale can be provided for recommending needs and types of technical and educational guidance materials. Comments are due March 19, 2013.
The National Institute for Occupational Safety and Health (NIOSH) is scheduled to publish in the December 19, 2012, Federal Register a request for information and comment on silver nanoparticles. According to the notice, NIOSH has initiated an evaluation of the scientific data on silver nanoparticles “to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted.” NIOSH has identified a number of “relevant publications” on silver nanoparticles, and this listing will be available in Docket CDC-2012-0014, at http://www.regulations.gov, once the Federal Register notice is published. NIOSH requests additional information concerning:
- Published and unpublished reports and findings from in vitro and in vivo toxicity studies with silver nanoparticles;
- Information on possible health effects observed in workers exposed to silver nanoparticles;
- Information on workplaces and products in which silver nanoparticles can be found;
- Description of work tasks and scenarios with a potential for exposure;
- Information on measurement methods and workplace exposure data; and
- Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to silver nanoparticles occur.
Comments will be due 60 days after the notice is published in the Federal Register.
On November 7, 2012, the National Institute for Occupational Safety and Health (NIOSH) Nanotechnology Research Center (NTRC) posted a document entitled Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004–2011. NIOSH established NTRC in 2004 to address occupational safety and health concerns associated with nanotechnology. The progress report summarizes program accomplishments from the inception of NTRC in 2004 through 2011. It includes an analysis of the progress made toward accomplishing the goals and objectives of the NIOSH Strategic Plan for Nanotechnology Research and toward addressing the goals and research needs identified in the National Nanotechnology Initiative (NNI) environmental, health, and safety (EHS) research strategy. The progress report states that NTRC “continues to support and promote the responsible development of nanotechnology through its ongoing research program and its contributions to the development of guidelines for hazard identification, exposure assessment, and risk characterization that can be used to develop and implement effective risk management practices.”
On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work Australia’s Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the published literature on the toxicity of carbon nanotubes, and concluded that multi-walled carbon nanotubes may cause damage to lungs through prolonged or repeated inhalation exposure. The report recommends classification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For all other endpoints, NICNAS found that carbon nanotubes either were not classified as hazardous, or cannot be classified as insufficient data are available. The information sheet summarizes the key findings from the report and discusses implications for manufacturers, importers, persons in control of a business or undertaking, and workers manufacturing or using products containing carbon nanotubes.
On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.
The Centers for Disease Control and Prevention (CDC) published a September 20, 2012, Federal Register notice seeking comment on a proposed National Institute for Occupational Safety and Health (NIOSH) exposure assessment and epidemiological study of U.S. workers exposed to carbon nanotubes (CNT) and carbon nanofibers (CNF). The notice states that the proposed research is a cross-sectional study of the current U.S. workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in two phases: (1) an industry-wide exposure assessment study to evaluate worker exposure and further develop and refine measurement methods for CNT and CNF; and (2) a cross-sectional study relating the best metrics of CNT and CNF exposure to markers of early pulmonary or cardiovascular health effects. The study will include a questionnaire given by NIOSH personnel as a computer-assisted personal interview, followed by medical examinations to evaluate pulmonary function and blood pressure, and collect sputum and blood. NIOSH will conduct statistical analyses to determine the nature of the relation between exposure to CNT and CNF and these biomarkers of early effect, considering potential confounding factors such as smoking, age, gender, and workplace coexposures, including non-engineered ultrafine particles. CDC invites comments on whether the proposed research is necessary for the proper performance of its functions, including whether the information shall have practical utility; the accuracy of its estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information. Written comments are due within 60 days of the notice.
EU-OSHA Posts Literature Review on Risk Perception and Communication on Nanomaterials in the Workplace
On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces.” The review intends to:
- Summarize the general principles and theories of risk perception and communication, referring to relevant trends and current guidance on these topics;
- Identify the stakeholders involved in risk perception and communication for nanomaterials in the workplace, and appraise relevant research, studies, surveys, and risk communication initiatives that have been done to date at national and international levels; and
- Consider the gaps in knowledge and limitations of the risk communication initiatives in this area, and suggest ways these might be addressed, with a view to proposing how to communicate with workers and employers on the potential risks of nanotechnologies and highlighting the difficulties involved.
EU-OSHA states that risk communication strategies need to help employers make informed decisions about their workplaces and put adequate prevention measures in place, and to empower individual workers to take personal control of their own situations to protect themselves adequately.
The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”:
- A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help focus action to protect workers:
- Review of the current evidence on the carcinogenic potential of carbon nanotubes (CNT), based on laboratory studies;
- The role of physical and chemical properties related to cancer development;
- CNT doses associated with changes to or damages in genes in laboratory animals and human tissue specimens;
- Workplace exposures to CNT; and
- Specific risk management actions needed to protect workers.
- A study linking nanoparticle exposure to cellular responses associated with autoimmune risks. In laboratory studies, exposures to certain types of nanoparticles produced cellular changes that are associated with risks for disorders of the autoimmune system such as rheumatoid arthritis.
- A recent paper highlighting the findings from an evaluation of the quality and completeness of information of nanomaterial safety data as it pertains to hazard identification, exposure controls, personal protective equipment, and toxicological information being communicated about the engineered nanomaterial. The study determined that the majority of the safety data sheets obtained in 2010-2011 provided insufficient data for communicating the potential hazards of engineered nanomaterials.
- In a paper published in June, NIOSH researchers scrutinize the “oxidative stress paradigm,” a widely accepted scientific model for understanding the processes that in general are associated with cellular damage, to better understand the processes that can occur from reactions to nanoparticles. The answer to this question will have important ramifications for the development of strategies for mitigation of potential adverse effects of nanoparticles.
- Recent findings indicating that improperly designed, maintained, or installed engineering controls may not be completely effective in controlling releases of nanomaterials into the workplace. Unprotected skin exposure to carbon nanofibers was noted in two instances and indicated the need for educating workers on the use of personal protective equipment.
- A summary of emission data collected at four facilities that volunteered to serve as test sites. The measurements indicated that specific tasks can release engineered nanomaterials into the workplace atmosphere and that traditional controls such as ventilation can be used to limit exposure. Much research is still needed to understand the impact of nanotechnology on health, and to determine appropriate exposure monitoring and control strategies.
The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop. Registration is open until July 13, 2012.
NIOSH Releases Guidance on General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories
The National Institute for Occupational Safety and Health (NIOSH) has posted a document entitled General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories, which contains recommendations on engineering controls and safe practices for handling engineered nanomaterials in laboratories and some pilot scale operations. According to NIOSH, it designed the guidance “to be used in tandem with well-established practices and the laboratory’s chemical hygiene plan.” The guidance notes that experimental animal studies indicate that potentially adverse health effects may result from exposure to nanomaterials, and that the routes of exposure include inhalation, dermal exposure, and ingestion. The guidance concludes that “[t]he full range of occupational hygiene controls will be necessary to limit exposures to nanomaterials as a means to prevent adverse health outcomes in the research community. Engineering and administrative controls can eliminate or minimize the amount of nanomaterials that will be present in workplace air or settled on surfaces. Personal protective equipment can be used where other types of controls are not available or practical.”
Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials
The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account for advances in technology or the latest data, FACOSH asked its Emerging Issues Subcommittee to analyze federal agencies’ use of PELs. As part of its review, the Subcommittee identified other issues of interest, including dispersible engineered nanomaterials (DENM). A document entitled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies” includes the following text concerning DENMs:
- OSHA defines nanomaterials as, “materials that have been purposefully manufactured, synthesized, or manipulated to have a size with at least one dimension in the range of approximately 1 to 100 nanometers and that exhibit unique properties determined by their size.”
- Published scientific studies have indicated that at least some DENMs are biologically active, have produced toxicological reactions in the lungs of exposed experimental animals, and may readily penetrate intact human skin. While DENMs are truly an emerging issue and published results are not plentiful, scientists and federal agencies, such as NIOSH, continue to conduct research to understand fully the potential health effects of exposure.
- Currently, both scientists and federal agencies agree that DENM toxicity depends heavily on the physical and chemical properties of the nanoparticles, such as particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity, and that these properties may differ substantially from those of the same material in macro-scale form.
EU OSHA Announces French Report on Feasibility of Epidemiological Surveillance System for Workers Exposed to Engineered Nanomaterials
The European Agency for Safety and Health at Work (EU OSHA) posted an item on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials. The resulting report “draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues.” According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies. The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few. In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. While the French report is dated 2011, an English summary is dated 2012.
Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration's (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations' Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.Continue Reading...
On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.
On March 5, 2012, Safe Work Australia announced the release of an information sheet on the safe handling and use of carbon nanotubes in the workplace and a document entitled Safe Handling and Use of Carbon Nanotubes. The information sheet provides an overview of risk management for carbon nanotubes, while Safe Handling and Use of Carbon Nanotubes describes two approaches to managing the risks: risk management with detailed hazard analysis and exposure assessment, and risk management by using control banding. Either or both of these methods may be used, depending on the circumstances. Safe Work Australia states that the guidance is applicable to other forms of carbon nanofibers, such as carbon nanorods and carbon nanowires. It is also applicable to products containing carbon nanotubes and other forms of carbon nanofibers where these nanomaterials may be released during handling. Safe Work Australia has commissioned a human health hazard assessment and classification of carbon nanotubes, and it expects to publish the findings in mid-2012.
The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop.
WHO Background Document on Guidelines on Protecting Workers from Manufactured Nanomaterials Available for Comment
The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments. The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.” Comments are due March 31, 2012.
The U.S. Environmental Protection Agency (EPA) has announced that, in response to public comments, it will provide the public more time to comment on the December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states “the comment period is being reopened until 45 days following publication of the new notice (until approximately mid-March).” Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW). The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers. These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the Occupational Safety and Health Administration (OSHA) standards as best practices.
This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.
NRC Publishes A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials
On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.Continue Reading...
The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Comments are due January 27, 2012.Continue Reading...
The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15 abstentions, also calls for the assessment of the effects of new technologies on health. The EP calls for legislation to ensure that nanomaterials are covered by the current European Occupational Health and Safety regulation.
Japan’s Ministry of Economy, Trade and Industry (METI) established a Committee on Safety Management for Nanomaterials, which was scheduled to hold its first meeting on December 2, 2011. METI states that it established the Committee “on the basis of the results obtained from the project ‘Research and Development of Nanoparticle Characterization Methods’ commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge.” The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. According to Japan’s November 30, 2011, press release, the Committee will compile an interim report “around spring to summer in 2012.”
NIOSH Science Blog Posts Entry Regarding Respiratory Protection for Workers Handling Engineered Nanoparticles
On December 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) posted an item on its Science Blog entitled “Respiratory Protection for Workers Handling Engineered Nanoparticles.” The purpose of the blog item is to provide an update on the science and rationale behind NIOSH’s recommendations for the use and selection of respirators against engineered nanoparticles. The article summarizes respirator performance research and respirator selection. Concerning next steps, NIOSH states that, while its research to date has been done in laboratory settings, using filtration test systems and manikins under aggressive test conditions, further research is needed in field settings and using human test subjects. According to NIOSH, “[w]ell-designed studies on face seal leakage of nanoparticles, especially workplace protection factor (WPF) studies that validate assigned protection factor (APF) levels for respirators against nanoparticles will be important,” and such studies are already underway.
ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade. ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS. ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field. According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.Continue Reading...
On November 8, 2011, the International Council on Nanotechnology (ICON) announced the availability of the presentation slides from the modules for the training course entitled “Introduction to Nanomaterials and Occupational Health.” The course was developed under a grant from the Occupational Safety and Health Administration (OSHA), and is intended to prepare safety professionals to address issues that may arise in the nanomaterial workplace by providing a comprehensive review of current knowledge, frameworks for risk management, and tools for keeping up with the rapidly expanding knowledge base on nanomaterials’ health and safety impacts. The course modules include:
- Introduction to Nanotechnology and Nanomaterials;
- What Workers Need to Know about Nanomaterial Toxicology and Environmental Impacts;
- Assessing and Controlling Exposure to Nanomaterials in the Workplace;
- Risk Management Approaches for Nanomaterial Workplaces;
- Regulations and Standards Relevant to Nanomaterial Workplaces; and
- Tools and Resources for Further Study.
On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. According to NNI, the workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that “knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy.”Continue Reading...
OECD Provides Snapshot on Current and Planned Activities on the Safety of Manufactured Nanomaterials
On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO).
The International Organization for Standardization (ISO) has published a new standard, ISO/TR 13121:2011, which describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials to protect the health and safety of the public, consumers, workers, and the environment. According to ISO, the standard offers guidance on the information needed to make sound risk evaluations and risk management decisions. The standard also includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders. The standard offers methods organizations can use to be transparent and accountable in how they manage nanomaterials, and describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials.
On March 25, 2011, the National Research Council (NRC) announced the availability of a report entitled Prudent Practices in the Laboratory, which updates NRC’s guidelines on the safe use of hazardous chemicals. NRC last updated the guidelines in 1995, and the new edition includes new topics, including the handling of nanomaterials. The update sets out general guidelines for the management of nanomaterials. NRC developed the guidelines “from accepted chemical hygiene protocols for handling compounds of unknown toxicity.” The guidelines cover topics such as planning and assessing the hazards of nanomaterial work, information on grading the risk of working with different types of nanomaterial, and suggestions on ways to make sure the working environment is designed to protect laboratory personnel from exposure to nanoparticles.
The National Institute for Occupational Safety and Health (NIOSH) announced that the University of Cincinnati NIOSH Education and Research Center (ERC) will sponsor a May 10, 2011, conference at the Department of Environmental Health, University of Cincinnati College of Medicine, on “Nanotechnology -- Health and Safety Considerations.” Registration is free. Speakers include:
- Dr. Andrew D. Maynard, Director, Risk Science Center, University of Michigan School of Public Health: “Nanomaterials dangerous? Who are you kidding! The art and science of working safely with sophisticated materials.”
- Dr. Kristen Kulinowski, Director, International Council of Nanotechnology, Rice University: “Training Workers to Safely Handle Nanomaterials.”
- Dr. Charles Geraci, NIOSH: “Recent Activities Specific to Carbon Nanotubes and Nano TiO2. What are they, do they have broad application, and how do they impact a risk management program?”
- Dr. Vesselin Shanov, University of Cincinnati: “Advances in synthesis and application of carbon nanotube materials.”
- Dr. Jagjit Yadav, University of Cincinnati: “Toxicology of nanomaterials.”
On March 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) announced that it seeks comment on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. According to the Federal Register notice, NIOSH would like to build on the accomplishments of ongoing research to develop strategic research goals and objectives through 2015. Comments are due April 15, 2011.Continue Reading...
On March 1, 2011, the American Society of Mechanical Engineers (ASME) Nanotechnology Institute posted the most recent podcast in its Nano Educational Series. The podcast concerns nano environmental health and safety, with Dr. Andrew Maynard, University of Michigan Risk Science Center. The next podcast, scheduled to be posted on March 15, 2011, will discuss modeling and simulation with Professor Wing Kam Liu, Northwestern University. According to the Institute, it intends to improve user’s technical literacy and provide information that will assist career planning and skills development. The podcasts are being offered on a complimentary basis, but users will first need to register.
On January 26, 2011, the International Organization for Standardization (ISO) announced the availability of a new standard, ISO 10808:2010, entitled “Nanotechnologies -- Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing.” The standard is intended to ensure that the results of inhalation toxicity tests of airborne nanoparticles are reliable and harmonized worldwide. According to ISO, the standard “establishes a battery of inhalation toxicity testing chamber monitoring, including a differential mobility analyzing system (DMAS), for determining particle number, size, size-distribution, surface area and estimated mass dose, as well as morphological examination using transmission electron microscopy (TEM) or scanning electron microscopy (SEM) equipped with an energy dispersive X-ray analyzer (EDXA) for chemical composition.”
On January 25, 2011, the European Agency for Safety and Health at Work (EU-OSHA) announced that French Agency for Environmental and Occupational Health Safety (ANSES) experts have developed a control banding tool specific to nanomaterials that can potentially be used in any work environment in which nanomaterials are manufactured or used. With control banding, new products are classified into “bands,” which are defined after comparison with the hazard level of known and/or similar products, while taking into account the assessment of exposure at the work station. The process combines a qualitative risk assessment with a risk control band and proposes minimum collective preventive measures to be implemented that are consistent with the estimated level of risk. EU-OSHA notes that, “[i]n particular, the proposed tool is especially adapted to [small- and medium-sized enterprises (SME)] which do not necessarily have at their disposal the metrological characterisation equipment or detailed toxicological studies required for a proper risk assessment process.”Continue Reading...
The Switzerland State Secretariat for Economic Affairs (SECO) has posted a December 21, 2010, guidance document for preparing safety data sheets (SDS) for synthetic nanomaterials. Safety Data Sheet (SDS): Guidelines for Synthetic Nanomaterials is intended to demonstrate the information necessary to ensure the safe handling of nano-objects and products that contain nano-objects; offer assistance on how the relevant information can be identified and in which form and which place they are to be listed in the SDSs; and contribute to making employees of companies that produce or process synthetic nano-objects aware of the particular properties of these materials. The Guidelines, which are limited to “specifically manufactured (i.e. synthetic) nano-objects which are nano-sized in two or three dimensions (i.e. nano-fibres or nano-particles),” include two fictitious examples of SDSs for synthetic nanomaterials. The Guidelines supplement the Federal Office of Public Health (FOPH) document entitled The Safety Data Sheet in Switzerland.Continue Reading...
NIOSH Seeks Comment on Draft CIB Concerning Occupational Exposure to Carbon Nanotubes and Nanofibers
The National Institute for Occupational Safety and Health (NIOSH) released a draft Current Intelligence Bulletin (CIB) entitled Occupational Exposure to Carbon Nanotubes and Nanofibers, which recommends that, until results from research studies can fully elucidate the physicochemical properties of carbon nanotubes (CNT) and carbon nanofibers (CNF) that define their inhalation toxicity, employers should take steps to minimize CNT and CNF exposures of all workers and implement an occupational health surveillance program that includes elements of hazard and medical surveillance. The draft CIB includes more specific recommendations for employers and workers to minimize potential health risks associated with exposure to CNTs and CNFs. NIOSH will hold a public meeting on the draft CIB on February 3, 2011, in Cincinnati, Ohio. According to NIOSH, during the meeting, it will place special emphasis on:
- Whether the hazard identification, risk estimation, and discussion of health effects for CNTs and CNFs are a reasonable reflection of the current understanding of the evidence in the scientific literature;
- Workplaces and occupations where exposure to CNTs and CNFs occur;
- Current strategies for controlling occupational exposure to CNTs and CNFs (e.g., engineering controls, work practices, personal protective equipment);
- Current exposure measurement methods and challenges in measuring workplace exposures to CNTs and CNFs; and
- Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).
Notification of intent to intend the meeting is due to NIOSH on January 28, 2011. Comments on the draft CIB are due February 18, 2011.
The National Institute for Occupational Safety and Health (NIOSH) announced on September 22, 2010, that it entered into a formal partnership with the National Science Foundation (NSF) Center for High-Rate Nanomanufacturing (CHN) that is intended to provide companies with practical research and guidance to promote occupational health and safety in nanotechnology. Through the new partnership, University of Massachusetts (UMass) Lowell, CHN, and NIOSH will “address safety issues so that discoveries can quickly turn into commercially available products.” NIOSH and UMass Lowell research teams will evaluate potential exposure to nanomaterials and recommend solutions at small- to medium-sized companies and research laboratories. NIOSH will publish best practices developed by UMass Lowell and CHN. UMass Lowell will host and NIOSH will co-sponsor the 5th International Symposium on Nanotechnology, Occupational, and Environmental Health on August 9-12, 2011, in Boston.
On July 1, 2010, the NanoBusiness Alliance issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.” The NanoBusiness Alliance is committed to working with governments and nanomaterials stakeholders to manage the sustainable development and use of nanomaterials in a responsible way. The Position Statement states:
As an enabling technology applicable to diverse fields, including alternative energy, medicine, and electronics, among many others, nanotechnology offers tremendous value to society. As with any emerging technology, nanotechnology and nanoscale materials must be managed in a responsible way to identify and minimize any potential adverse effect on human health or the environment. The Alliance is committed to fostering the responsible and sustainable development of nanotechnology, to working with governmental and related nanotechnology stakeholders to develop appropriate scientific testing tools, methodologies, and data to characterize nanoscale materials, and to developing informed, science-based governance policies, laws, standards, practices, and regulations pertinent to nanoscale materials.
On April 27, 2010, ILO published a booklet entitled “Emerging Risks and New Patterns of Prevention in a Changing World of Work,” which summarizes new occupational safety and health issues, including those related to technical innovations such as nanotechnology. The booklet states:
There is a big knowledge gap between advances in the application of nanotechnology and its impact on health. Due to the extensive and highly diversified use of nanomaterials in industry, the number of workers exposed is also difficult to estimate. While little is known about the health and environmental impact of these new materials, it is likely that workers will be among the first to experience high rates of exposure.
According to ILO, the need to share information about emerging risks is “vital, at both the national and international levels.” ILO notes that “[t]he study of nanomaterials, for example, illustrates the importance of knowledge sharing in the development and application of new technologies, whereby the identification and assessment of associated hazards and risks need to be considered and communicated at a stage before widespread application in industry.”
On January 19, 2010, the National Institute for Occupational Safety and Health (NIOSH) announced three new peer-reviewed articles co-authored by NIOSH researchers. According to NIOSH, the articles report findings and conclusions from studies that examined issues related to potential occupational exposure to engineered nanomaterials. Two articles in the Journal of Occupational and Environmental Hygiene report on the design and application of the nanomaterial emission assessment technique, which was developed by the NIOSH nanotechnology field evaluation team. Part A describes the technique (Journal of Occupational and Environmental Hygiene, 7:127-132), while Part B discusses findings from use of the technique at 12 facilities. NIOSH states that the results summarized in Part B “demonstrated that the technique is useful in identifying and evaluating sources of nanomaterial emissions, and for evaluating engineering controls intended to minimize emissions and reduce exposures” (Journal of Occupational and Environmental Hygiene, 7:163-176). The third article, highlighted as a “featured research” paper in EHP, examines the potential for occupational exposure to engineered carbon-based nanomaterials in environmental laboratory studies. The article cautions that under some conditions, engineered nanomaterials can become airborne when mixed in solution by sonication.
Last month, Bayer Material Science (BMS) announced that it derived an occupational exposure limit (OEL) of 0.05 milligrams per cubic meter (mg/m3) for Baytubes, BMS multi-wall carbon nanotubes. According to BMS, “[t]he latest results of sub-chronic inhalation studies support the conclusion that Baytubes act like poorly soluble particles.” BMS derived the OEL based on previous single and recent repeated inhalation studies. BMS states: “All relevant information are now included in the updated Safety Data Sheet and will further ensure that our customers work safely with our Baytubes.”
The National Institute for Occupational Safety and Health (NIOSH) announced that it will hold a conference entitled “Nanomaterials and Worker Health: Medical Surveillance, Exposure Registries, and Epidemiologic Research,” on July 21-23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado. According to NIOSH, the goal of the conference is to identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers. The conference will include invited and submitted papers, breakout sessions to allow for small group discussions, and poster presentation.
On November 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) released two nanotechnology publications. NOISH posted a document entitled Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The Report updates the February 2007 version, which described the progress of the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006. In the November 2009 Report, NIOSH describes program accomplishments achieved in 2007 and 2008. NIOSH states that the NTRC has, with limited resources, continued to make contributions to all the steps in the continuum from hazard identification to risk management. The second document, entitled Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps, updates the September 2005 Strategic Plan using knowledge gained from results of ongoing research as described in the 2007 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 update. NIOSH states that the Strategic Plan for the nanotechnology program is the roadmap it is using to advance knowledge about the implications and applications of nanomaterials.
On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”
On September 23, 2009, EHP-in-Press posted an article entitled “Potential for Occupational Exposure to Engineered Carbon-Based Nanomaterials in Environmental Laboratory Studies,” which states that laboratory workers may be at increased risk of exposure to engineered nanomaterials. The goal of the study was to assess the release of carbonaceous nanomaterials into the laboratory atmosphere during handling and sonication into environmentally-relevant matrices. The authors concluded that engineered nanomaterials can become airborne when mixed in solution by sonication, especially when nanomaterials are functionalized or in water containing natural organic matter. EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.
The California Department of Toxic Substances Control (DTSC) announced it will host the DTSC/California Nano-Industry Network Symposium, to be held November 16, 2009, in Sacramento, California. The Symposium, which is co-sponsored by the American Chemistry Council and Dupont, will use the DTSC’s nanotechnology data call-in as a backdrop. According to the preliminary agenda, the Symposium will feature two sessions. The first, entitled “Collaborative Efforts,” will discuss the key U.S. and international forums for collaboration on the health, safety, and environmental impacts of nanomaterials. The second session, “Company Engagement with Nanotechnology Safety,” will review examples of how companies can apply the evolving knowledge on nanomaterials safety to address systematically various areas of concern.
The August 2009 issue of Nature Nanotechnology includes an article entitled “Essential Features for Proactive Risk Management,” written by Vladimir Murashov, Ph.D., Special Assistant to the Director of the National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., former NIOSH Director. The authors “propose a proactive approach to the management of occupational health risks in emerging technologies based on six features: qualitative risk assessment; the ability to adapt strategies and refine requirements; an appropriate level of precaution; global applicability; the ability to elicit voluntary cooperation by companies; and stakeholder involvement.”
The September 2009 issue of the European Respiratory Journal will contain a study entitled “Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma.” The study examines the relationship between a group of workers presenting with “mysterious” symptomatic findings and their nanoparticle exposure. The authors conducted surveys of the workplace, made clinical observations, and examined the patients -- seven young female workers (aged 18 to 47 years), exposed to nanoparticles for five to 13 months, all with shortness of breath and pleural effusions. According to the study abstract, polyacrylate, consisting of nanoparticles, was confirmed in the workplace. Using transmission electron microscopy, nanoparticles were observed to lodge in the cytoplasm and caryoplasm of pulmonary epithelial and mesothelial cells, but are also located in the chest fluid. The authors state that these cases “arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs.” The study is not yet available on the European Respiratory Journal website.Continue Reading...
According to its website, the National Institute for Occupational Safety and Health (NIOSH) has joined the International Journal of Occupational and Environmental Health in inviting submission of scientific papers for a special issue of the Journal. The special edition is provisionally entitled “Human and Environmental Exposure Assessment for Nanomaterials,” and will be edited by Vladimir Murashov, Ph.D., a special assistant to the NIOSH Director. Submissions are due January 15, 2010. More information about submission requirements can be found on the Journal’s website.
The National Institute for Occupational Safety and Health (NIOSH) has posted a link to an article entitled “National Nanotechnology Partnership to Protect Workers,” which proposes the creation of a National Nanotechnology Partnership led by NIOSH. The article, posted online on July 7, 2009, by the Journal of Nanoparticle Research, suggests the partnership be a collaboration of government agencies, manufacturers, users, and others. The authors are John Howard, M.D. former NIOSH Director, and Vladimir Murashov, Ph.D., NIOSH.
On July 15, 2009, the National Institute for Occupational Safety and Health (NIOSH) announced plans to hold a conference entitled “Nanomaterials and Worker Health: Occupational Health Surveillance, Exposure Registries, and Epidemiological Research.” The conference is intended to identify gaps in information about potential occupational health effects of nanomaterials, as well as address questions related to occupational health and safety.Continue Reading...
The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review -- Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does not include nanomaterials originating from natural sources, as well as non-intended nanoscale by-products, such as diesel engine exhaust, and welding fumes. To provide a broad overview, EU-OSHA collected information from different sources, such as scientific literature, policy documents, legislation, and work programs. EU-OSHA gave priority to documents from the European Union (EU), although national and international activities are also described. The report considers studies published up to November 2008. The report identifies the following topics as priorities for future actions and activities:
- Identification of nanomaterials and description of exposure;
- Measurement of exposures to nanomaterials and efficacy of protective measures;
- Risk assessment of nanomaterials in line with the current statutory framework;
- In vivo studies for assessment of the health effects of nanomaterials;
- Validation of the in vitro methods and methods of physico-chemical properties as methods to determine health effects; and
- Training of workers and practical handling guidelines for activities involving nanomaterials in the workplace.
On April 14, 2009, the Australian Council of Trade Unions (ACTU) issued a press release entitled “Nanotech Poses Possible Health and Safety Risk to Workers and Needs Regulation.” According to ACTU, “[t]he rapidly growing nanotechnology market in Australia requires urgent regulation to protect the health and safety of workers and consumers.” ACTU notes that, currently, there is no mandatory register in Australia of who is importing, manufacturing, supplying, or selling nanomaterials, and no requirement to label products.Continue Reading...
On April 8, 2009, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing that it “intends to evaluate the scientific data on carbon nanotubes (CNTs) and develop appropriate communication documents, such as an Alert and/or Current Intelligence Bulletin [CIB], which will convey the potential health risks and recommend measures for the safe handling of these materials.” CIBs are issued by NIOSH “to disseminate new scientific information about occupational hazards. A CIB may draw attention to a previously unrecognized hazard, report new data on a known hazard, or disseminate information on hazard control.”Continue Reading...
On March 18, 2009, the European Union’s European Agency for Safety and Health at Work (EU-OSHA) announced the results of a report entitled Expert Forecast on Emerging Chemical Risks Related to Occupational Safety And Health. According to the Agency, “[c]ontact with a wide range of chemicals and other hazardous substances at work is endangering the health of workers across Europe, and nanotechnology is one of the risks causing most concern to experts from 21 European countries.” The report identifies the main groups of substances that could pose new and increasing risks to workers, contributing to diseases ranging from allergies, asthma, and infertility to cancer.Continue Reading...
On March 30, 2009, the National Institute for Occupational Safety and Health (NIOSH) posted a document entitled Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials. The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. NIOSH released a draft version of the document for comment in October 2005, and then released a revised and updated version for additional comment in July 2006. According to NIOSH, the final version of this document “incorporates some of the latest results of NIOSH research, but it is only a starting point.” NIOSH states that 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.
On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”Continue Reading...
NIOSH Issues Update Regarding Paper on Issues in Developing Worker Epidemiological Studies Related to Engineered Nanoparticles
According to a February 27, 2009, National Institute for Occupational Safety and Health (NIOSH) Update entitled “Issues in Developing Worker Epidemiological Studies Related to Engineered Nanoparticles Are Discussed in Paper,” NIOSH scientists and a colleague from Emory University have prepared a paper concerning issues that researchers will need to consider in designing sound epidemiological studies of workers who may be exposed to engineered nanoparticles in the manufacturing and commercial use of nanomaterials. According to the authors, even though the fundamental principles of epidemiology can be applied to engineered nanoparticles, researchers will face challenges typically not encountered in studies involving traditional materials. These challenges relate to the unique characteristics and properties of engineered nanomaterials, the relative newness of nanotechnology, and the fact that nanotechnology is not an industry in itself, but a process that may involve different industry sectors and occupational groups. The factors that would influence the design of an epidemiological study include:
- Heterogeneity (the chemical and physical diversity of engineered nanoparticles);
- Temporal factors (the challenge that nanotechnology, generally, has not been in use for the length of time it may take for some diseases to become apparent);
- Disease endpoints (determining what diseases or symptoms to look for on the basis of limited research evidence);
- Exposure characterization (determining what to measure and how to measure it); and
- Study population (finding a group of workers for a study who have been exposed to the same type of engineered nanoparticle at levels high enough and for a long enough time to provide scientifically reliable and comparable results).
The paper will be published by the Journal of Occupational and Environmental Medicine.
NIOSH Offers Interim Guidance For Worker Medical Screening, Hazard Surveillance Pertaining To Engineered Nanoparticles
On February 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of “Current Intelligence Bulletin 60: Interim Guidance for the Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles.” NIOSH offers the following recommendations for workplaces where workers may be exposed to engineered nanoparticles in the course of their work:
- Take prudent measures to control exposures to engineered nanoparticles;
- Conduct hazard surveillance as the basis for implementing controls; and
- Continue use of established medical surveillance approaches.
According to NIOSH, its recommendations respond to ongoing interest by employers and other stakeholders in having authoritative occupational safety and health guidance in the manufacturing and industrial use of engineered nanomaterials. NIOSH states that its recommendations also reflect its ongoing leadership in providing such interim scientific guidance as research progresses for determining whether engineered nanomaterials pose risks for adverse occupational health effects.
On April 2, 2009, NanoCap and the European Parliament (EP) will hold a conference entitled “Working and Living with Nanotechnologies: Trade Union and NGO positions.” The conference objectives are to present positions and perspectives on nanotechnologies at the workplace and in the environment adopted by European trade unions and environmental non-governmental organizations (NGO), including:
- Setting priorities for the responsible development of nanotechnologies, especially regarding environmental and workplace safety;
- Exchanging views with nanotechnologies stakeholders and policymakers;
- Establishing pathways for implementing the precautionary approach; and
- Presenting a nanoethics portfolio.
On September 18, 2008, the U.S. Environmental Protection Agency (EPA) announced that, to ensure nanotechnology is developed in a responsible manner, the National Science Foundation (NSF) and EPA awarded $38 million to establish two Centers for the Environmental Implications of Nanotechnology (CEIN). EPA contributed $5 million to the overall award, which is the largest award for nanotechnology research in its history. The CEINs will conduct research on the possible environmental, health, and safety impacts of nanomaterials, using very different approaches than previous studies. Led by the University of California at Los Angeles (UCLA) and Duke University, the CEINs will study how nanomaterials interact with the environment and human health, and are intended to result in better risk assessment and mitigation strategies to be used in the commercial development of nanotechnology. Each CEIN will work as a network, connected to multiple research organizations, industry, and government agencies, and will emphasize interdisciplinary research and education.Continue Reading...
In its latest Background Paper, entitled Mounting Evidence That Carbon Nanotubes May Be the New Asbestos, Friends of the Earth Australia (FOEA) is calling “for an immediate moratorium on the commercial use of carbon nanotubes and the sale of products that incorporate nanotubes until research can demonstrate whether or not there is any safe level of exposure to them.” FOEA also is calling for new nanotechnology-specific regulation to protect human health and the environment, as well as for mandatory labeling of all nanoscale materials used in the workplace and in consumer products.Continue Reading...
On May 20, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted an entry on its science blog entitled “Nanotechnology: Should carbon nanotubes be handled in the workplace like asbestos?” The entry was prompted by the release of two recent reports contributing to the carbon nanotube/asbestos fiber comparison debate. The entry asks what the implications are to the risk assessment and risk management of carbon nanotubes in U.S. workplaces, and states:
However, questions have been raised about using these research findings for risk assessment analysis in the light of study limitations such as use of model animals, artificial administration methods, and sometimes extremely high doses, which are not representative of those exposures usually present in the workplace environment. Such limitations are not unusual for pioneering scientific studies. They simply mean that at this stage of the research, gaps remain that need to be closed by further study before quantitative risk assessment can be conducted.Continue Reading...
GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research
On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:
- Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials
- Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
- Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
- Guidance for Handling and Use of Nanomaterials at the Workplace
- Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
- Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials
Documents on Safety Research:
- Roadmap for Safety Research on Nanomaterials
- Environmental Aspects of Nanoparticles
DuPont and Environmental Defense (ED) will hold two interactive workshops on nano risk management. The workshops are intended to give participants the tools they need to:
- Understand (and explain to others) why nano-specific risk management is necessary;
- Assemble and leverage the internal and external resources to implement nano-specific risk management; and
- Begin implementing nano-specific risk management in an efficient and effective manner.
The workshops will include:
- Interactive discussions of how to implement nano-specific risk management;
- Case studies of nano-specific risk management in use by companies and governments; and
- Sources of additional help for companies adopting these approaches.
The first workshop will be held April 2, 2008, at the Sustainable Packaging Coalition in San Francisco, California. A second workshop will be held April 8, 2008, at the Toxics Use Reduction Institute in Boston, Massachusetts.
Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson and Ira Dassa published an article appearing in the Fall 2007 issue of Sustainable Development Law and Policy. The article discusses several issues in connection with the application of the Toxic Substances Control Act (TSCA) to engineered nanoscale materials.
Draft CIB on Medical Screening of Workers Potentially Exposed to Nanoparticles Available for Comment
Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight
On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:
- Food applications of nanoscience and nanotechnologies -- Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA);
- Consumer products applications of nanoscience and nanotechnologies -- Dr. Michael Holman, Lux Research;
- Health applications of nanoscience and nanotechnologies -- Dr. Carole Moquin-Pattey, European Science Foundation (ESF);
- Nanotechnology risk assessment: Knowns and unknowns -- Mr. Herman B.W.M. Koëter, Deputy Executive Director and Director of Science, European Food Safety Authority (EFSA);
- Nanoparticle toxicology: Scientific state-of-the-art -- Professor Ken Donaldson, University of Edinburgh;
- Nanomaterials. Risk assessment needs -- Professor Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR);
- The EU perspective on policy and regulatory aspects -- Mr. Kees Brekelmans; Enterprise and Industry Directorate General, “Consumer Goods” Directorate;
- Nanotechnology and the Food and Drug Administration: Science and Policy -- Dr. Richard Canady, U.S. Food and Drug Administration (FDA); and
- The consumer perspective on applications of nanoscience and nanotechnologies -- Dr. Sue Davies, Chief Policy Advisor, Which?.
The Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted on October 9, 2007, a seminar on the Responsible NanoCode, a voluntary, principles-based Code of Conduct for entities involved in the research, development, manufacture, and retail sale of products using nanotechnologies. The draft Code was developed by a working group organized in late 2006 by The Royal Society, the United Kingdom’s (UK) national academy of science, in conjunction with Insight Investment, the Nanotechnology Industries Association (NIA), and the UK government-sponsored Nanotechnology Knowledge Transfer Network.