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.
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.”
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.
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.
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.
NIOSH 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 (PPE); (7) fire and explosion safety; (8) recommendations and guidance; (9) communication and information; and (10) applications. NIOSH states that it is considering focusing the overarching strategic research goals for these critical areas on five key goals:
- Provide guidance to protect workers;
- Alert workers, employers, governments, and the public about possible new hazards;
- Assess the hazards of nanomaterials and the risks to workers;
- Help workers by assessing and implementing exposure registries; and
- Assess the level of protection practiced in U.S. workplaces.
NIOSH requests comment on how research in the ten critical areas and five overarching goals can be enhanced. Examples of requested information include the need for toxicity evaluation and/or workplace exposure characterization of engineered nanoparticles not currently being studied; development of technical and educational guidance materials; development of additional partnerships and collaborations; and research in the development of risk management strategies.
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) has posted an October 2010 Impact Sheet entitled “NIOSH Research Methods Demonstrate that Breathing Nanoparticles May Result in Damaging Health Effects,” which reports the results of recently published research concerning the health effects of inhaling single-walled carbon nanotubes. According to the Impact Sheet, NIOSH scientists invented a way to suspend nanotubes in air, thus allowing for control of the concentration of particles, unlike previous studies, which dosed the mice through aspiration. NIOSH scientists placed the mice into a controlled environment where they would breathe the air containing the particles, and studied the effects of exposure after one, seven, and 28 days. The Impact Sheet states that, although the effects were similar, the new results “demonstrated that carbon nanotubes were more potent when inhaled than when aspirated.” According to NIOSH, “this research has shown early indications of serious health outcomes that may have longer term effects such as cancer, and therefore, ongoing research is important to more clearly understand the implications of exposure to carbon nanotubes. This study and continued NIOSH research could soon help the development of occupational safety and health recommendations for carbon nanotubes that will protect the health of nanotechnology workers.”
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.
The National Institute for Occupational Safety and Health (NIOSH) announced that laboratory studies, reported in a paper posted online by the journal Nature Nanotechnology on April 4, 2010, discovered that carbon nanotubes were biodegraded by an enzyme found in white blood cells, neutrophils. According to NIOSH, the researchers demonstrated that, unlike carbon nanotubes that were not biodegraded in this way, the biodegraded nanotubes did not cause inflammation in the lungs of mice. NIOSH states that the results are important for scientists in evaluating the biological effects of carbon nanotubes, particularly their fate and role in inflammation, and that more research would be needed for determining the applicability of the findings in assessing potential risk in occupational exposures.
The U.S. Environmental Protection Agency (EPA) published on February 3, 2010, a proposed significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for multi-walled carbon nanotubes. The proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due March 5, 2010.
The proposed rule provides the following basis for action:
The PMN states that the substance will be used as an additive/filler for polymer composites and support media for industrial catalysts. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance. For the uses described in the PMN, worker inhalation and dermal exposures are minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of gloves and protective clothing, where there is a potential for dermal exposure; use of the substance without a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with an N100 cartridge, where there is a potential for inhalation exposure; or use other than as described in the PMN, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at 721.170(b)(3)(ii).
The proposed SNUR would apply only to the multi-walled carbon nanotubes described in premanufacture notice (PMN) P08-199. According to EPA, in the past, some stakeholders have asked whether these types of SNURs apply to all variants of carbon nanotubes. EPA states: “This is not the case.” The chemical name listed in the proposed SNUR is “multi-walled carbon nanotubes (generic),” and the CAS Number is “not available.” On November 6, 2009, EPA published a proposed SNUR for the multi-walled carbon nanotubes described in PMN P08-177.
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.
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.
The U.S. Environmental Protection Agency (EPA) has announced the Interagency Nanotechnology Implications Grantees Workshop, which will feature presentations on recent research by EPA, the National Science Foundation (NSF), National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS), National Institute for Occupational Safety and Health (NIOSH), and Department of Energy (DOE) grant researchers. According to EPA, the November 9-10, 2009, meeting “will encourage collaboration and cooperation among nanotechnology grantees sponsored by EPA, NSF, NIEHS, NIOSH and DOE and between other federal grantees and federal nanotechnology researchers.” The meeting is open to members of academia, government, nongovernmental organizations, industry, and the general public. Two agendas are available: (1) other nanomaterials; and (2) metals and carbon-based nanomaterials.
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.”
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.
In a notice in the August 4, 2009, Federal Register, the Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) released its latest report to the Administrator. Under TSCA Section 4(e), the ITC is required ‘‘to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of rules for testing.” According to the report, “the ITC has no revisions to the TSCA section 4(e) Priority Testing List at this time.”
The report also describes the ITC’s emphasis during the reporting period (November 2008 to May 2009) on nanoscale materials and how best to regulate them. It summarizes the ITC’s recent reviews of the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program’s interim report and the National Institute for Occupational Safety and Health’s (NIOSH) nanotechnology guidelines. The report concludes by recommending data needs of ITC organizations be addressed and lists many of the data deficiencies.
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.
According to NIOSH’s website, the conference will strive to:
- Share existing knowledge;
- Identify major issues;
- Examine successful approaches; and,
- Explore new approaches, techniques and models.
The conference is currently scheduled for three days in July 2010 and will be held in Colorado.
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.”
According to the notice, NIOSH has developed guidelines for managing the potential health concerns associated with occupational exposures to engineered nanoparticles, which “will provide the framework for developing specific recommendations for CNTs.” Comments are due May 15, 2009.
NIOSH is requesting the following information:
- Published and unpublished reports and findings from in vitro and in vivo toxicity studies with CNTs;
- Information on possible health effects observed in workers exposed to CNTs;
- Information on workplaces and products in which CNTs can be found;
- Description of work tasks and scenarios with a potential for exposure;
- 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 CNTs occur.
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.
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.
The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN).
EDF obtained a redacted copy of the consent order, and provides the following summary of the requirements:
- Conduct a 90-day inhalation toxicity test in rats;
- Supply EPA with a one-gram sample of its MWCNTs and its Material Safety Data Sheet;
- Submit certain characterization data within six months after commencing full manufacture;
- Require its workers to wear protective gloves and clothing shown to be impermeable and National Institute for Occupational Safety and Health (NIOSH)-approved respirators;
- Use the substance only for a particular use, claimed confidential but generically identified as a “property modifier” in electronics and polymer composites; and
- Provide the nanomaterial only to entities that agree to the same use restrictions and worker protection conditions.
In an October 2, 2008, Update entitled “NIOSH Nanotechnology Research News Notes: New Papers on PPE, Toxicity; New Partnerships, Award,” the National Institute for Occupational Safety and Health (NIOSH) describes two new peer-reviewed papers, two new international partnerships, and a professional award.
- Shvedova, et al., “Inhalation Versus Aspiration of Single Walled Carbon Nanotubes in C57BL/6 Mice: Inflammation, Fibrosis, Oxidative Stress and Mutagenesis” -- Mice that inhaled carbon nanotubes from an aerosol suspended in the air showed the same dose-related effects as mice that were exposed in past studies through a different method, the direct aspiration of carbon nanotubes into the lung. Effects included the formation of granulomas in the lungs of exposed mice, and lung tissue fibrosis. Due to the lack of workplace exposure data, scientists are unable at present to predict whether workers would experience similar effects through workplace exposures, or whether the effects would signal a risk for impairment or death, either in and of themselves or as precursors to other effects.
- Rengasamy, et al., “Filtration Performance of NIOSH-Approved N95 and P100 Filtering Facepiece Respirators Against 4 to 30 Nanometer-Size Nanoparticles” -- Evaluations of NIOSH-approved N95 and P100 filtering-facepiece respirators for reducing exposures to nanometer-sized silver aerosol particles supported previous studies that found that such respirators should provide expected levels of protection against nanoparticles, when fitted, maintained, and used properly.
- The International Alliance for NanoEHS Harmonization (IANH) -- Four NIOSH researchers representing combined interdisciplinary expertise in laboratory and field studies are part of IANH, a new international research partnership. IANH intends to establish scientific protocols to promote harmonization in the toxicological testing of nanomaterials.
- Organization for Economic Cooperation and Development (OECD) Workshop -- NIOSH is leading the formation of an October 20, 2008, workshop on the assessment and mitigation of workplace exposures to nanomaterials. During the workshop, representatives of the OECD Working Party on Manufactured Nanomaterials and invited outside experts will explore the latest developments, needs, and opportunities in research.
- The Richard C. Knudson Publication Award, 2008 -- The American Biological Safety Association presented this award to Vladimir V. Murashov, Ph.D., Special Assistant to the Director, NIOSH, and John Howard, M.D., former Director of NIOSH, for the paper “Biosafety, Occupational Health, and Nanotechnology.” The award recognizes “significant contributions in areas of scientific investigation and/or health and safety.”
The National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization. According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to biological systems, to that of internationally accepted standards to accelerate research, development, risk identification, regulation, and widespread public adoption of nanotechnology. The workshop is intended to address this need on several fronts. Workshop sponsors and contributors include: ASTM International; Food and Drug Administration (FDA); Nanotechnology Characterization Laboratory (NCL) at NCI-Frederick; National Cancer Institute (NCI); National Institute for Occupational Safety and Health (NIOSH); NIST; National Institute of Environmental Health Sciences (NIEHS); and Oregon Nanoscience and Microtechnologies Institute (ONAMI). The workshop is limited to 100 attendees.
MRC Epidemiology Resource Centre, University of Southampton, United Kingdom
Public health reason for IARC to undertake this review?
Nanotechnology is developing rapidly with many potential applications. Evidence is beginning to emerge that nanotubes could pose cancer risks similar to those from asbestos.
Natural Resources Defense Council
If the substance was previously reviewed, what new information would lead to a change in the evaluation?
Multiwalled Carbon Nanotubes (MWCNT): Substantial animal studies report that exposure to MWCNTs by tracheal installation induces progressive, irreversible lung fibrosis that would likely lead to cancer. New data strongly suggests the potential for single-walled carbon nanotubes (SWCNT) to cause lesions that may lead to mesothelioma. The potentially-widespread use of these new materials and allied potential for exposure and harm argue strongly for an evaluation of existing literature. Objective review of existing information is critical to support appropriate actions across the globe on this potential carcinogen.
Public health reason for IARC to undertake this review?
Widespread water contaminant.
Paul A. Schulte, Ph.D.
National Institute for Occupational Safety and Health
Public health reason for IARC to undertake this review?
Carbon nanotubes are likely to be used increasingly in a large number of products. Therefore, increasing numbers of workers may be exposed to them. Preliminary information indicates that carbon nanotubes may have similar carcinogens potential as other durable natural or man-made fibers.
To assist IARC in selecting substances for review, it is convening an Advisory Group to review all public nominations and to recommend those it considers to be of high priority. According to IARC, the Advisory Group “may also propose additional agents at the meeting for discussion and possible inclusion on their list of recommended priorities. In making their recommendations, the Advisory Group will consider near-term public-health priorities and recent research and research in progress.” The Advisory Group will meet on June 17-20, 2008.
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.The entry also asks how workers should be protected today, and states: “In the workplace, developing and implementing a workplace risk management program (including evaluating the hazards, assessing worker exposures, installing and evaluating engineering controls, establishing procedures for personal protective equipment, and providing worker education and training programs) can minimize worker exposure to carbon nanotubes. NIOSH recommends that such prudent practices be used while scientists continue the research that is needed for better risk assessment.”
- Nanotechnology Field Research Team Update: NIOSH conducted site visits to facilities involved in the research, manufacture, or use of various types of nanomaterials. NIOSH is using the information it obtained to develop workplace guidance documents to protect nanotechnology workers from occupational injury and illness. NIOSH states that it learned that:
- Basic particle counting and sizing instruments can be used to identify emissions from nanomaterial processes;
- Careful interpretation of the particle data is needed to differentiate between incidental (background) and process-related nanoparticles; and
- Engineering controls do minimize workplace exposure to engineered nanoparticles.
NIOSH encourages companies interested in receiving a visit by the Field Research Team to contact it. All site visits are initiated by the respective companies and are completely voluntary.
- NIOSH Nanotechnology Field Research Effort Fact Sheet: NIOSH created a Field Research Team to assess workplace processes, materials, and control technologies associated with nanotechnology and to conduct on-site assessments of potential occupational exposure to a variety of nanomaterials. Through this effort, NIOSH intends to gather baseline data to assist in determining potential occupational safety and health implications of exposure to engineered nanomaterials and developing guidance to ensure safe working conditions. Participation is open to research laboratories, producers, and manufacturers working with engineered nanomaterials. NIOSH states that the data collected by the field research team will be communicated back to the participant. NIOSH may then use the data in a general manner to update its guidance on occupational safety and health implications of exposure to nanomaterials, and make it available in technical documents, scientific presentations, or on the NIOSH website. NIOSH will not identify participants in any documents that are disseminated publicly without their permission.
- NIOSH Nanotechnology Metal Oxide Particle Exposure Assessment Study: As part of its nanotechnology research agenda, NIOSH initiated a study to investigate exposure to fine (0.1 µm to 2.5 µm diameter) and ultrafine (<0.1 µm diameter) metal oxides. NIOSH specifically designed the study to conduct a detailed evaluation of exposures to fine and ultrafine metal oxides, and is not the same as the baseline assessment program offered by the NIOSH Nanotechnology Field Research Team. NIOSH asks manufacturers and end-users of fine and ultrafine metal oxides to participate in this study. NIOSH states: “More specifically, workers at these facilities who are involved in the production and use of metal oxides will be asked to participate.” According to NIOSH, participants will benefit because NIOSH’s sampling results “may provide companies with a better understanding of metal oxide exposure occurring in their facility. Areas of contamination, if any, will be identified and recommendations to reduce exposure will be provided when possible. A report of the findings will be sent to each company that participates.” NIOSH will use the data to determine the extent to which metal oxide exposure is occurring in the nanotechnology industry. NIOSH states: “The information will be used for scientific research purposes only, and published study results will not identify participating companies.”
The goals for NIOSH nanotechnology research are as follows:
- Determine if nanoparticles and nanomaterials pose risks for work-related injuries and illnesses;
- Conduct research to prevent work-related injuries and illnesses by applying nanotechnology products;
- Promote healthy workplaces through interventions, recommendations, and capacity building; and
- Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.
The NIOSH Nanotechnology Research Center (NTRC) identified ten critical research areas that will be used to address the strategic goals:
- Exposure assessment;
- Toxicity and internal dose;
- Epidemiology and surveillance;
- Risk assessment;
- Measurement methods;
- Engineering controls and personal protective equipment;
- Fire and explosion safety;
- Recommendations and guidance;
- Communication and information; and
The NTRC efforts are organized according to the ten critical research areas. NIOSH will identify and characterize hazards, assess exposure, characterize risk, and develop risk management guidance through targeted research in each of the critical areas.
On December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research:
- On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to establish a NIOSH-led project to: (1) exchange information on measuring and controlling exposures to nanomaterials; and (2) develop suggestions for further steps by the Working Party.
- At a December 4-7, 2007, meeting, a project group of the International Organization for Standardization (ISO) Technical Committee 229 voted to approve a draft report of safety and health practices in occupational settings relevant to nanotechnology. The draft report was based on NIOSH’s interim document entitled Approaches to Safe Nanotechnology, and was developed with NIOSH leadership and participation on the project group.
- On December 2, 2007, NIOSH participated in a meeting of the World Health Organization’s (WHO) Global Network of Collaborating Centres in Occupational Health, focusing on nanotechnology. The objective of the meeting was to determine how the WHO collaboration can develop and support research and cooperation in preventing exposure to potentially hazardous engineered nanoparticles. NIOSH is collaborating on five communication and networking projects with various WHO centers.
Draft CIB on Medical Screening of Workers Potentially Exposed to Nanoparticles Available for Comment
According to the December 12, 2007, Federal Register notice, during the meeting, NIOSH will place special emphasis on discussion of the following:
- Do the data support the conclusions of the document?
- Are the conclusions appropriate in light of the current understanding of toxicological data?
- Is medical surveillance appropriate at this time for workers with potential exposure to engineered nanoparticles; if so, what form(s) of medical surveillance are specific for such workers?
- What are the potential benefits, adverse impacts, and limitations of medical screening of workers potentially exposed to engineered nanoparticles?
- What are the potential benefits, adverse impacts, and limitations of establishing an exposure registry for workers exposed to engineered nanoparticles?
Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight
The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:
- Purpose: Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology. The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
- Current Understanding: The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications. As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
- Information Development: Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment. To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
- Risk Assessment and Risk Management: The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation. As experience is gained, these approaches can be refined. The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
- International: Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation. The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community. The federal government should also promote access to information across the international community. These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
- Regulatory Path Forward: In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
- Regulation should focus where need exists and where scientific information supports action (e.g., targeted to specific groups and classes of materials instead of a “one-size-fits-all” approach);
- Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
- Where possible, regulatory approaches should enable rather than hinder innovation;
- Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
- Benefits of regulation should justify their costs;
- Regulations should be developed in an open and transparent manner; and
- Regulations and guidance should consider established requirements and guidance such as the following:
- Executive Order (EO) 12866 -- Regulatory Planning and Review (Oct. 4, 1993);
- Information Quality Act and Information Quality Guidelines: OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002);
- National Technology Transfer and Advancement Act of 1995;
- Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (Feb. 10, 1998);
- OMB Final Information Quality Bulletin for Peer Review (Dec. 16, 2004);
- OMB Final Bulletin for Agency Good Guidance Practices (Jan. 18, 2007); and
- OMB/OSTP Memorandum: Updated Principles for Risk Analysis (Sept. 19, 2007).
NTRC’s goals, and progress made toward each, include:
- Determine if nanoparticles and nanomaterials pose risks for work-related injuries and illnesses.
NTRC has conducted toxicology research on the properties and characteristics of nanoparticles that are relevant for predicting adverse health effects. To gain further knowledge about exposure and control practices, NTRC established a field team to conduct assessments of workplaces where exposure to engineered nanoparticles may occur. To date, this team has partnered with various companies that produce or use engineered nanoparticles to obtain information on potential worker exposures, control technologies, and risk management practices.
- Conduct research on the application of nanotechnology for the prevention of work-related injuries and illnesses.
NTRC has identified various possibilities for applying nanotechnology to occupational safety and health, including its application in fabricating more efficient filters, sensors, and protective clothing. NTRC has also conducted numerous discussions with academia and the private sector on other potential projects. Efforts are underway between NTRC, other Centers for Disease Control and Protection (CDC) personnel, and the Georgia Institute of Technology to identify collaborative projects involving nanotechnology applications to occupational and public health problems.
- Promote healthy workplaces through interventions, recommendations, and capacity building.
NTRC provided guidance for workers and employers in a document entitled Approaches to Safe Nanotechnology: An Information Exchange with NIOSH. Other information products on the NIOSH website include the nanotechnology topic page (with an extensive selection of frequently asked questions) and the Nanoparticle Information Library (NIL), which is a resource on particle information including physical and chemical characteristics. In addition, NTRC convened a cross-federal group to develop a framework document for health surveillance of workers exposed to nanomaterials. According to NTRC, this document will involve the business community to identify the range of issues involved in occupational health surveillance.
- Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.
The NTRC research program identified ten critical topic areas that it believes are important for understanding the potential health risks of nanoparticles and developing and disseminating recommendations. The report describes each of these critical topic areas and the research being conducted. These topic areas are the core of the NTRC research program and represent the areas that are most critical to addressing occupational safety and health issues. They include toxicity and internal dose; risk assessment; epidemiology and surveillance; engineering controls and personal protective equipment; measurement methods; exposure assessment; fire and explosion safety; recommendation and guidance; communication and education; and applications. By working in these ten critical areas, NIOSH states that it “has comprehensively begun to address the information and knowledge gaps necessary to protect workers and responsibly move nanotechnology forward so that its far reaching benefits may be realized.”
NTRC established several national and international collaborations to advance understanding of occupational safety and health for nanotechnology workers. NTRC participates in the National Nanotechnology Initiative (NNI) and has contributed to the nanotechnology strategic plan through the working group on Nanotechnology Environmental and Health Implications (NEHI). Occupational safety and health has been a major priority of the NEHI effort, and NIOSH’s strategic research plan and activities address most of the major issues in the NEHI plan. NTRC collaborated with the Organization for Economic Cooperation and Development (OECD) to build cooperation, coordination, and communication between the U.S. and 30 OECD member countries, including the European Union (EU), and with more than 180 nonmember economies, as well. NTRC is part of the U.S. leadership on the International Organization for Standardization (ISO) TC 229 Nanotechnology Working Group on Health, Safety, and the Environment. NTRC also works with the World Health Organization (WHO) Collaborating Centers on global projects of information dissemination and communication.