On October 6, 2014, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) entitled “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” The Regulatory Agenda item linked to the proposed rule states that EPA is developing a significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) that would require persons who intend to manufacture, import, or process these chemical substances 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. In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. A previous proposed rule had been under OMB review since November 22, 2010. Neither proposed rule has been publicly released.
Bergeson & Campbell, P.C., is pleased to announce that Managing Partner Lynn L. Bergeson and the late Michael F. Cole prepared a chapter in a new book, Biointeractions of Nanomaterials, which covers a wide range of issues associated with the safety of nanomaterials in biological systems. The book, published on July 29, 2014, by CRC Press, addresses issues related to the toxicity and safety of nanomaterials and nanosystems, and covers a range of interactions in biological systems, specifically focusing on the tools and methods used for evaluation, including in vivo and in vitro techniques.Continue Reading...
On July 29, 2014, the House Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade held a hearing on “Nanotechnology: Understanding How Small Solutions Drive Big Innovation.” Witnesses included:
- James M. Tour, Ph.D., T.T. and W.F. Chao Professor of Chemistry, Professor of Computer Science, Materials Science and Nanoengineering, Smalley Institute for Nanoscale Science and Technology, Rice University;
- Christian Binek, Ph.D., Associate Professor Physics and Astronomy, University of Nebraska - Lincoln;
- Milan Mrksich, Ph.D., Henry Wade Rogers Professor of Biomedical Engineering, Chemistry and Cell and Molecular Biology, Northwestern University; and
- Jim Phillips, Chairman and Chief Executive Officer, NanoMech, Incorporated.
Subcommittee Chair Lee Terry stated that “nanotechnology is poised to drive the next surge of economic growth across all sectors.” According to Dr. Binek, nanotechnology has the potential to transform a range of industries, in fields such as information technology, medical applications, energy, water supply with strong correlation to the energy problem, smart materials, and manufacturing. Dr. Tour encouraged steps to help the U.S better compete with markets abroad, and suggested Congress work with industry, tax experts, and universities to design an effective incentive structure to increase industry support for research and development. Professor Mrksich discussed the economic opportunities of nanotechnology, and obstacles to realizing these benefits. According to Mrksich, current challenges “include the development of strategies to ensure the continued investment in fundamental research, to increase the fraction of these discoveries that are translated to technology companies, to have effective regulations on nanomaterials, to efficiently process and protect intellectual property to ensure that within the global landscape, the United States remains the leader in realizing the economic benefits of the nanotechnology industry.” Mr. Phillips testified: “It’s time for America to lead. . . . We must capitalize immediately on our great University system, our National Labs, and tremendous agencies like the National Science Foundation, to be sure this unique and best in class innovation ecosystem, is organized in a way that promotes nanotechnology, tech transfer and commercialization in dramatic and laser focused ways so that we capture the best ideas into patents quickly, that are easily transferred into our capitalistic economy so that our nation’s best ideas and inventions are never left stranded, but instead accelerated to market at the speed of innovation so that we build good jobs and improve the quality of life and security for our citizens faster and better than any other country on our planet.” An archived webcast of the hearing and witness testimony are available online.
On July 29, 2014, the Office of Science and Technology Policy (OSTP) and the National Economic Council (NEC) published a Federal Register notice requesting public comments to provide input for an upcoming update of the Strategy for American Innovation. According to the notice, the Strategy “helps to guide the Administration’s efforts to promote lasting economic growth and competitiveness through policies that support transformative American innovation in products, processes, and services and spur new fundamental discoveries that in the long run lead to growing economic prosperity and rising living standards.” The national priority areas outlined in the 2011 Strategy include nanotechnology. The 2011 Strategy states:
The President is committed to investments in innovation that promise to drive better health, future economic growth, and quality jobs in America. . . . The National Nanotechnology Initiative (NNI) is investing in areas such as nanoelectronics, which will foster a revolution in computing comparable to the transition from the vacuum tube to the transistor. And the FY 2012 Budget is making substantial investments to accelerate breakthroughs in advanced manufacturing technologies that can provide foundations for private sector investment and growth.
The July 29, 2014, Federal Register notice includes a number of questions, grouped into the following categories of innovation policy topics:
- Overarching questions;
- Innovation trends;
- Science, technology, and research and development priorities;
- Skilled workforce development;
- Manufacturing and entrepreneurship;
- Regional innovation ecosystems;
- Intellectual property/antitrust;
- Novel government tools for promoting innovation; and
- National priorities.
Comments are due September 23, 2014.
On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative (NNI) agencies to advance the current state of the science as highlighted in the Progress Review. Representative research activities as provided in the Progress Review will be discussed in the context of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy’s six core research areas: nanomaterial measurement infrastructure; human exposure assessment; human health; the environment; risk assessment and risk management methods; and informatics and modeling. Questions on the Progress Review document may be submitted beginning July 24, 2014, through the close of the webinar. During the question-and-answer segment of the webinar, submitted questions will be considered in the order received.
OECD Publishes Report of Expert Meeting on Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines
On July 15, 2014, the Organization for Economic Cooperation and Development (OECD) posted the July 2014 Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines. The Report presents the discussion and recommendations from the February 28-March 1, 2013, workshop on “Physico-chemical Properties of Manufactured Nanomaterials and Test Guidelines.” OECD notes that the workshop was organized “in close collaboration with the International Organization for Standardization Technical Committee on Nanotechnologies (ISO/TC 229),” which “provided an important dimension for the analysis of the physical-chemical properties of manufactured nanomaterials.” The discussion focused on selected endpoints and those existing OECD Test Guidelines and other methods and protocols that are being used to address them. The categories of endpoints selected included:
- State of Dispersion, Aggregation and Agglomeration of Nanomaterials;
- Size (and Size Distribution) of Nanoparticles;
- Surface Area and Porosity; and
- Surface Reactivity.
Four breakout groups were formed with the task to address the following questions:
- Identify the relevance of these endpoints as additions to conventional physical-chemical characterization; and if relevant, outline possible methods (i.e., new OECD Test Guidelines) based on the outcomes of the OECD Testing Program and other sources of information;
- Identify whether there is a need for specific guidance documents for testing and assessment of the physical-chemical properties of nanomaterials or adaptation of existing OECD Guidance Documents;
- Discuss whether specific sections should be developed for the “Guidance on Sample Preparation and Dosimetry” (GSPD) on the basis of the experiences obtained in the Testing Program and other new developments in the area of testing and assessment of physical-chemical properties; and
- Identify whether specific endpoints and/or OECD Test Guidelines are relevant to different categories of nanomaterials.
On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which provides an overview of progress on the implementation and coordination of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy that was developed by the Nanoscale Science, Engineering, and Technology Subcommittee’s Nanotechnology Environmental and Health Implications (NEHI) Working Group. According to the NNI, consistent with the adaptive management process described in the Research Strategy, “the NEHI Working Group has made significant progress through the use of various evaluation tools to understand the current status of nanotechnology-related EHS (nanoEHS) research and the Federal nanoEHS research investment.” NNI states: “Most notably, the participating agencies reported to the NEHI Working Group examples of ongoing, completed, and anticipated EHS research (from FY 2009 through FY 2012) relevant to implementation of the 2011 NNI EHS Research Strategy.” Overall, according to NNI, coordination and implementation of the 2011 NNI EHS Strategy across the NEHI agencies has enabled:
- Development of comprehensive measurement tools that consider the full life cycles of engineered nanomaterials (ENM) in various media;
- Collection of exposure assessment data and resources to inform workplace exposure control strategies for key classes of ENMs;
- Enhanced understanding of the modes of interaction between ENMs and physiological systems relevant to human biology;
- Improved assessment of transport and transformations of ENMs in various environmental media, biological systems, and over full life cycles;
- Development of principles for establishing robust risk assessment and risk management practices for ENMs and nanotechnology-enabled products that incorporate ENMs, as well as approaches for identifying, characterizing, and communicating risks to all stakeholders; and
- Coordination of efforts to enhance data quality, modeling, and simulation capabilities for nanotechnology, towards building a collaborative nanoinformatics infrastructure.
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) published a Federal Register notice on June 19, 2014, requesting available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. According to NICEATM, it will use submitted information “to determine the technical requirements for developing effective inhalation toxicity tools to assess potential chemical or nanomaterial hazards without using animals.” NICEATM requests that respondents provide information on any activities relevant to the development and/or validation of alternatives to in vivo inhalation toxicity test methods currently required by regulatory agencies. NICEATM states that this could include submission of substance-specific data derived from non-animal tests to identify acute inhalation hazard potential. If available, NICEATM requests corresponding in vivo data for these substances, “including data from any ethical human or animal studies or accidental human exposures.” Submissions are due July 18, 2014.
The U.S. Environmental Protection Agency (EPA) has awarded a $5 million, four-year grant to investigators led by Arizona State University to study the life cycle of nanomaterials. According to EPA’s description of the award, the project involves an interdisciplinary team of chemists, toxicologists, scientists, engineers, and social scientists to evaluate the trade-offs between intended function of nanomaterials in products and risks to humans and the environment across their life cycle from creation, through use and disposal. The description states that researchers will evaluate four product lines expected to have variable nanomaterial release rates (i.e., dispersed in liquids used in industrial manufacturing (e.g., polishing agents), dispersed in products (e.g., foods), embedded in composite polymers (e.g., thermoplastics, membranes for water filtration), and coated on the surfaces of flexible polymeric materials (e.g., textiles) using four high-volume nanomaterials (titanium dioxide, silicon dioxide, nanosilver, and multi-wall carbon nanotubes) that exhibit properties unique from each other and properties similar to other emerging nanomaterials. The description states that the results are expected to:
- Reduce uncertainty in risks from nano-enabled products for the public, manufacturing communities, and regulatory agencies;
- Provide the framework for existing and future nano-enabled product designs that preserve commercial value while minimizing adverse environmental health and safety effects;
- Train a diverse group of undergraduate, graduate, and post-doctoral scientists to work as a network and produce integrated research products; and
- Educate the public on the importance of the life cycle perspective for maximizing the benefits of nano-enabled products.
On March 25, 2014, the National Nanotechnology Initiative (NNI) published a supplement to President Obama’s 2015 budget request submitted to Congress on March 4, 2014. The supplement provides a description of the activities underway in 2013 and 2014 and planned for 2015 by the federal government agencies participating in the NNI, primarily from a programmatic and budgetary perspective. NNI states that it is based on the NNI Strategic Plan and reports actual investments for 2013, estimated investments for 2014, and requested investments for 2015 by Program Component Area (PCA). NNI states that the President’s 2015 budget provides over $1.5 billion for NNI, “reflect[ing] nanotechnology’s potential to significantly improve our fundamental understanding and control of matter at the nanoscale and to translate that knowledge into solutions for critical national issues.” According to NNI, the investments in 2013 and 2014 and proposed for 2015 “continue the emphasis on accelerating the transition from basic R&D to innovations that support national priorities, while maintaining a strong base of foundational research, to provide a pipeline for future nanotechnology-based innovations.”
On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs. The bill would reauthorize the National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in the development of new technologies and products based on breakthroughs in our understanding of materials at the atomic and molecular level.” Under the bill, the National Nanotechnology Coordination Office (NNCO) would develop and maintain a public database of projects funded under at least the environmental, health, and safety (EHS) program component area, or any successor program component area. The database would include a description of each project, its source of funding by agency, and its funding history. The bill states that the National Nanotechnology Program will include research on: (1) the development of instrumentation and tools required for the rapid characterization of nanoscale materials and for monitoring of nanoscale manufacturing processes; and (2) approaches and techniques for scaling the synthesis of new nanoscale materials to achieve industrial-level production rates. On March 6, 2014, the bill was referred to the House Committee on Science, Space, and Technology and to the Committee on Education and Workforce. On March 11, 2014, the bill was referred to the Science, Space, and Technology Subcommittee on Research and Technology.
On February 25, 2014, the National Science Foundation (NSF) announced the results of an NSF and National Nanotechnology Coordination Office (NNCO)-funded independent study that identifies more than $1 trillion in global revenue from nano-enabled products in 2013. NSF states that, to help quantify the global growth in nanotechnology research and development, Lux Research released a new report on global spending for emerging nanotechnology and the next generation of nano-enabled products. According to NSF, the findings “help illustrate the long-term impact investments in fundamental science and engineering research under an innovative initiative can have on the global marketplace.” NSF states:
The survey shows global funding for emerging nanotechnology has increased by 40-to-45 percent per year for the last three years. It shows that revenue from nano-enabled products grew worldwide from $339 billion in 2010 to $731 billion in 2012 and to more than $1 trillion in 2013. Revenue from the United States alone was $110 billion, $236 billion and $318 billion those same years, respectively.
OECD Issues Expert Meeting Report on Ecotoxicology and Environmental Fate of Manufactured Nanomaterials
On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate. As part of OECD’s Program on the Safety of Manufactured Nanomaterials, it initiated a series of expert meetings intended to improve the applicability of the OECD Test Guidelines (TG) to nanomaterials. The main objective of the meeting was to assess the applicability of existing TGs to manufactured nanomaterials, with a view to:
- Identify the needs for updating the OECD TGs related to environmental fate and ecotoxicology, and developing new nanospecific TGs;
- Identify specific needs for developing/updating existing guidance documents, including identifying the need for additional sections for fate and ecotoxicology testing of nanomaterials; and
- Develop separate specific or adapt existing guidance documents for environmental fate and ecotoxicology testing of nanomaterials.
Meeting participants concluded that OECD TGs 201, 211, 222, 225, 305, 315, and 317 are applicable to engineered nanomaterials (ENM). According to the participants, TG 105 is not appropriate for nanomaterials, and a TG should be developed that addresses the dissolution behavior of ENMs. The participants concluded that TG 106 for measuring the adsorption and desorption behavior of a substance in soils cannot be applied for the testing of nanomaterials, since no valid differentiation between adsorbed and not adsorbed ENMs is possible. The OECD report includes specific recommendations regarding the application of each TG to ENMs and details about the data analysis, acceptable loss of the ENMs during the test, endpoints, test procedure, selection of the test media, and target organism.
On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and commercialization of engineered nanomaterials.” NIOSH states that, for fiscal years 2013-2016, it will continue to fill information and knowledge gaps addressing the five NIOSH Nanotechnology Research Center (NTRC) strategic goals:
- Increase understanding of new hazards and related health risks to nanomaterial workers;
- Expand understanding of the initial hazard findings of engineered nanomaterials;
- 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;
- Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies; and
- Assess and promote national and international adherence with risk management guidance.
To address these strategic goals and promote the responsible development of engineered nanomaterials, NIOSH states that the strategic plan will expand research activities in ten critical areas: toxicity and internal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk assessment; engineering controls and personal protective equipment (PPE); fire and explosion safety; recommendations and guidance; global collaborations; and applications.
On December 13, 2013, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) released its preliminary opinion on “Nanosilver: safety, health and environmental effects and role in antimicrobial resistance.” The opinion is intended to assess whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver, and whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms. SCENHR states that it “concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver.” Human exposure is direct, through food, hand-to-mouth contact, and skin, and may be life long. Silver nanoparticles “may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time.” SCENIHR thus cannot rule out “additional effects caused by widespread and long term use” of nanosilver. Regarding the hazard associated with the dissemination of the resistance mechanism following the use of nanosilver, SCENIHR notes that there is no documentation available, “representing a serious gap of knowledge.” According to SCENIHR, “[s]ince other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria -- which is extremely relevant for developing resistance -- the potential of [nanosilver] to induce similar effects should be given particular attention.” SCENIHR states that more data are needed to understand better the bacterial response to ionic silver and nanosilver exposure. SCENIHR could not determine whether resistant microorganisms will increase and spread in view of a more widespread use of nanosilver because the mechanisms resulting in nanosilver resistance are not well understood. Comments on the preliminary opinion are due February 2, 2014.
The Federal Institute for Risk Assessment (BfR) announced on November 27, 2013, that it completed NanoView, a research project on the perception of nanotechnology by the German population and media. Under the project, BfR examined whether the population’s perceptions and attitudes towards nanotechnology have changed over the last five years, as well as whether the presentation of nanotechnology in the media has changed. According to BfR, the results show that the majority of respondents are still largely unfamiliar with the term nanotechnology, and that fewer reports on the subject appear in the media than five years ago. BfR notes that, despite the existing knowledge gaps, a “clear majority” see the benefits of nanotechnology as outweighing any potential risks. BfR describes a “noteworthy” finding regarding the differences between the sexes, in that “men’s attitudes towards nanotechnology are clearly more positive than those of women; men are more likely to advocate nanotechnology.” BfR states: “By implementing a targeted communications strategy, the BfR strives to make a contribution to closing the knowledge gaps. In particular, the different information needs of men and women must be taken into account: men tend to prefer fact-based information about nanotechnology, whereas women would like recommendations relevant to everyday life that they can easily convert into concrete behaviour.”
On November 19, 2013, the National Science and Technology Council, Committee on Technology, and Subcommittee on Nanoscale Science, Engineering, and Technology requested public comments on the draft 2014 National Nanotechnology Initiative Strategic Plan. The Strategic Plan provides the framework within which each National Nanotechnology Initiative (NNI) agency will carry out its nanotechnology programs and is intended to sustain coordination of interagency activities. The Strategic Plan includes the following goals: (1) advance a world-class nanotechnology research and development program; (2) foster the transfer of new technologies into products for commercial and public benefit; (3) develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and (4) support responsible development of nanotechnology. According to the draft Strategic Plan, “success will be measured by continual and substantive progress toward the four goals.” The program component areas were revised to represent better the current state of nanotechnology, improving their alignment with the goals and objectives of the Strategic Plan. Objectives in the draft Strategic Plan were revised to reflect advances in nanotechnology and evolving stakeholder needs. Sub-objectives were assigned to each objective to improve consistency among the goals. NNI requests comments of approximately one page or less in length (4,000 characters). According to the November 19, 2013, Federal Register notice, comments are due December 17, 2013. The NNI website states that comments are due December 18, 2013, however.
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 Product Quality Research Institute (PQRI) will hold a January 14-15, 2014, workshop on “Nanomaterial Drug Products: Current Experience and Management of Potential Risks.” The goals and objectives of the workshop, which is co-sponsored by the United States Pharmacopeia (USP) and American Association of Pharmaceutical Scientists (AAPS) and endorsed by the Society of Toxicology (SOT) are to:
- Review analytical science and methods for characterizing nanomaterials;
- Share experiences and results using multiple formulation platforms for the same active pharmaceutical ingredient (API);
- Discuss approaches to the management of potential risks of nanomaterials in drug products starting from early drug development and throughout the product lifecycle;
- Gather input regarding the considerations for utilizing nanotechnology in pharmaceutical products;
- Present experience and perspectives from international regulatory agencies and standards setting organizations on the use of nanotechnology in pharmaceutical products; and
- Discuss areas where additional research on the effects of nanosize APIs on absorption, distribution, metabolism, elimination, and toxicity may be needed.
The expected outcomes are to establish opportunities for collaboration between academia, industry, and government-sponsored research programs and develop a summary report of the workshop discussions and recommendations.
EPA Releases Final Comprehensive Environmental Assessment Applied to MWCNTs in Flame-Retardant Coatings in Upholstery Textiles
The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments. The final report presents a case study of multiwalled carbon nanotubes (MWCNT) used in flame-retardant coatings applied to upholstery textiles. EPA states that the case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product life cycle, environmental transport and fate, exposure-dose in receptors (i.e., humans, ecological populations, and the environment), and potential impacts in these receptors. EPA notes that the final report “is not a health, risk, or exposure assessment and as such does not draw conclusions about potential risks, or present an exhaustive review of the literature.” Instead, according to EPA, it presents the research priorities identified by experts to aid research planning. EPA states that the outcomes of these research efforts may subsequently inform long-term MWCNT assessments.
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 August 9, 2013, Particle and Fibre Toxicology published a study entitled “Extrapulmonary transport of MWCNT following inhalation exposure.” The authors report that inhalation exposure studies of mice were conducted to determine if multi-walled carbon nanotubes (MWCNT) distribute to the tracheobronchial lymphatics, parietal pleura, respiratory musculature, and/or extrapulmonary organs. The study states that tracheobronchial lymph nodes were found to contain 1.08 and 7.34 percent of the lung burden at 1 day and 336 days post-exposure, respectively. On average, according to the study, there were 15,371 and 109,885 fibers per gram in liver, kidney, heart, and brain at 1 day and 336 days post-exposure, respectively. The burden of singlet MWCNT in the lymph nodes, diaphragm, chest wall, and extrapulmonary organs at 336 days post-exposure was significantly higher than at 1 day post-exposure. The abstract offers the following conclusions: “Inhaled MWCNT, which deposit in the lungs, are transported to the parietal pleura, the respiratory musculature, liver, kidney, heart and brain in a singlet form and accumulate with time following exposure. The tracheobronchial lymph nodes contain high levels of MWCNT following exposure and further accumulate over nearly a year to levels that are a significant fraction of the lung burden 1 day post-exposure.” Although the authors are affiliated with the National Institute for Occupational Safety and Health (NIOSH), the study includes a disclaimer that the findings and conclusions in the study are those of the authors and do not necessarily represent the views of NIOSH.
Lynn L. Bergeson Co-Authors Article on Use of Alternative Test Strategies for Nanomaterial Safety Assessment
ACS Nano has published an article entitled “A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment,” which is co-authored by Lynn L. Bergeson. The article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test strategies (ATS) for decision-making analyses of engineered nanomaterials (ENM). After discussions, participants generated a short list of generally shared viewpoints, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. The article is available for purchase online.
On July 30, 2013, Particle and Fibre Toxicology published a study entitled “Distribution and fibrotic response following inhalation exposure to multi-walled carbon nanotubes.” In the study, the authors tested the hypothesis that inhalation exposure to multi-walled carbon nanotubes (MWCNT) produces a fibrotic response and that the response is chronically persistent. Male C57BL/6 J mice were exposed in a whole-body inhalation system to a MWCNT aerosol, and the authors examined the fibrotic response in the alveolar region at up to 336 days after termination of exposure. The conclusion states: “Despite the relatively low fraction of the lung burden being delivered to the alveolar tissue, the average thickness of connective tissue in the alveolar region increased by 70% in the 336 days after inhalation exposure. These results demonstrate that inhaled MWCNTs deposit and are retained within the alveolar tissue where they produce a progressive and persistent fibrotic response up to 336 days post-exposure.” While a number of the authors are affiliated with the National Institute for Occupational Safety and Health (NIOSH), the study includes a disclaimer that the findings and conclusions are those of the authors and do not necessarily represent the views of NIOSH.
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.
The National Research Council (NRC) announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:
- Improve information gathering and communication at the project level;
- Develop and implement interagency plans for focused areas;
- Rework the NNI website to serve better the diversity of stakeholder groups;
- Take advantage of new technologies for data collection and analysis; and
- Identify, share, and implement best practices, especially relating to technology transfer and commercialization.
In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies.
Industry Consortium for Environmental Measurement of Nanomaterials Publishes Practical Nano Measurement Guide
The Industry Consortium for Environmental Measurement of Nanomaterials (ICEMN) announced today the release of a series of articles to serve as a practical guide for state and federal regulatory agencies tasked with measuring engineered nanomaterials in the environment. The articles, published in the March 2013 special issue of Environmental Engineering Sciences, were prepared by academic and industrial scientists from ICEMN and focus on the techniques and issues around nanomaterial measurement in water, air, and soil. The series of articles collates sources of primary literature and summarizes secondary literature on experimental evidence of release of nanomaterials from nano-enabled products and the capture of nanomaterials in wastewater treatment, and reviews the methodological and measurement strategy issues involved in quantifying engineered nanomaterials in the environment.Continue Reading...
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 Organization for Economic Cooperation and Development (OECD) published on February 14, 2013, the updated Current Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table. The purpose of the Tour de Table is to allow each delegation the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. According to OECD, this will facilitate the implementation of the projects of the WPMN by allowing delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future co-operation and co-ordination.
Environment International recently posted online an article entitled “Comparative evaluation of antimicrobials for textile applications.” The authors provide an overview of the main compounds currently used -- triclosan, silane quaternary ammonium compounds, zinc pyrithione, and silver-based compounds, including nanosilver. The authors evaluated scientific publications, market data, and regulatory documents to consider the potential effects of antimicrobials on the environment and on human health, taking life cycle perspectives into account. The authors summarize the characteristics of each compound according to technical, environmental, and human health criteria. The authors conclude that the application rates of the antimicrobials used are an important parameter, “with treatments requiring lower dosage rates offering clear benefits in terms of less active substance required to achieve the functionality.” While the authors concluded that “each antimicrobial technology has specific risks and benefits that should be taken into account in evaluating the suitability of different antimicrobial products,” the abstract states: “The results also indicated that nanoscale silver and silver salts that achieve functionality with very low application rates offer clear potential benefits for textile use.” The project was partially funded by HeiQ Materials AG, which obtained the U.S. Environmental Protection Agency’s first conditional registration for nanosilver.
Oral arguments were held on January 16, 2013, in the Natural Resources Defense Council’s (NRDC) case challenging the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20, a nanosilver product. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California). During oral arguments, EPA maintained that NRDC lacks standing to challenge the conditional registration. The judges appeared to reject EPA’s argument, suggesting that NRDC could prevail because of the low bar for establishing standing to challenge a rulemaking. The judges seemed less persuaded by NRDC’s argument that EPA erred in choosing three-year-olds rather than nine-month-olds as the most vulnerable subpopulation on which to base risk values. According to NRDC, EPA should have used infants, who are more likely to chew on textiles and could have higher exposures. EPA responded that EPA has a long-standing practice of using three-year-olds in risk assessments with similar exposure patterns to AGS-20, and that its use of three-year-olds was supported by leaching studies. NRDC further argued that EPA failed to consider the risk of aggregate exposures from other nanosilver products on the market. EPA responded that it applied uncertainty factors to account for data gaps and that HeiQ must submit more data to obtain a full registration.
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 December 11, 2012, the U.S. Environmental Protection Agency (EPA) and U.S. Consumer Product Safety Commission (CPSC) announced a research collaboration intended to assess potential impacts of nanomaterials on people’s health and the environment. According to EPA’s press release, the research is part of a “larger international effort” that includes:
- Identifying, characterizing and quantifying the origins of nanomaterials;
- Studying biological processes affected by nanomaterials that could influence risk;
- Determining how nanomaterials interact with complex systems in the human body and the environment;
- Involving industry to develop sustainable manufacturing processes; and
- Sharing knowledge through innovative online applications that allow for rapid feedback and accelerated research progress.
The press release states that CPSC will use the results of the research to inform:
- Protocol development to assess the potential release of nanomaterials from consumer products;
- Credible rules for consumer product testing to evaluate exposure; and
- Determination of the potential public health impacts of nanomaterial used in consumer products.
On November 28, 2012, the Canada-U.S. Regulatory Cooperation Council (RCC) held a webinar to discuss its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to information presented during the webinar, while the U.S. has received 137 notifications concerning nanomaterial substances, Canada has received only 16. While most of the nanomaterial substances notified in the U.S. were inorganic carbon, most of those notified in Canada were mixed metal oxides. During the webinar, both Canadian and U.S. spokespersons noted the difficulty in sharing information, due to confidential business information (CBI) claims. The RCC would like to be able to share information to inform better their regulatory programs and risk assessment/management approaches. This would include:
- General Substance Information: Substance name, company, applications, volumes; and
- Technical Substance Specific Information: Physchem properties, technical studies, and use pattern information.
The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.Continue Reading...
The presentations from the August 14-16, 2012, “Safe Nano Design: Molecule » Manufacturing » Market” workshop are now available. The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center held the workshop, during which participants provided 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 focused 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. A summary of all of the outcomes from each panel discussion is in development. Lynn L. Bergeson was on the Planning Committee for the workshop, and presented remarks.
Environmental Defense Fund (EDF) announced on November 12, 2012, the creation of a website intended to serve as a resource for understanding new chemical testing approaches. These approaches are typically less costly and time-consuming than animal-based tests. EDF notes that while the U.S. Environmental Protection Agency (EPA) has invested resources to create research programs to advance new types of chemical testing and assessment approaches, questions for users remain. EDF’s website includes the following resources:
- Chemical Testing in the 21st Century: A Primer -- An introduction to EPA’s Computational Toxicology (CompTox) research initiative and its component programs, such as ToxCast; a discussion of the opportunities and challenges of these new testing programs; and a discussion of issues and needs for greater engagement by the public interest community; and
- Chemical Testing in the 21st Century: Webinar Series -- Linked audio and video recordings of each of EDF’s three webinars (held in October) featuring EDF and EPA scientists exploring the basics of EPA’s new testing programs and the promises and challenges they present.
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 24, 2012, the National Academies released a report entitled Sustainable Development of Algal Biofuels, which was produced at the request of the U.S. Department of Energy (DOE). According to the report, biofuels made from algae could provide a domestic source of renewable fuel, but with current technologies, increasing production of algal biofuels to meet five percent of U.S. transportation fuel needs could “create unsustainable demands for energy, water, and nutrient resources.” While algal biofuels have the potential to improve the sustainability of the transportation sector, their potential is not yet realized and additional innovations requiring research and development are necessary to achieve the full potential. The report recommends that the environmental, economic, and social effects of algal biofuel production and use be compared with those of petroleum-based fuels and other fuel alternatives to determine whether algal biofuels contribute to improving sustainability. The report states that such comparison will be possible “only if thorough assessments of each step in the various pathways for algal biofuel production are conducted.”
On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a joint working group to review risk assessment procedures and new challenges for risk assessment, taking into account both fundamental and practical considerations, and to provide a scientific discussion paper on the issue. According to the preliminary opinion, a number of additional factors, including the need to assess more complex products and processes, e.g., products of nanotechnologies, make a thorough examination of current and potential future methods particularly timely. The preliminary opinion states that research is needed for developing models suitable for predicting the fate of nanomaterials. Fully new approaches need to be developed, conceptually different from the traditional molecular-based models. The preliminary opinion states that SCENIHR, SCCS, and SCHER “are aware that the most of the proposals described in this discussion paper are not realistically suitable for amending, in the short term, risk assessment procedures for regulatory purposes. However, this discussion paper highlights needs and priorities for research in order to get the objective of higher precision, accuracy and transparency in risk assessment for protecting human and environmental health." Comments are due November 30, 2012.
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.
On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities.” The brochure notes that “[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials.” According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD’s activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation.
On September 5, 2012, the National Research Council (NRC) released a pre-publication version of a report entitled Science for Environmental Protection: The Road Ahead. The U.S. Environmental Protection Agency (EPA) asked NRC to assess EPA’s overall capabilities “to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities.” The report discusses nanotechnology as an example of using emerging science to address regulatory issues and support decision-making. The Committee states that, to have the capacity to address emerging tools, technologies, and challenges, EPA “will need to have enough internal expertise to identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions; determine what existing tools and strategies can be applied to answer those questions; determine the needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the science to make recommendations based on hazards, exposures, and monitoring.” According to the report, the example of engineered nanomaterials “illustrates some of the problems and pitfalls of current approaches to emerging technologies.” While EPA provided early funding regarding the use of nanotechnology in remediation, the report states that it missed the opportunity to support research addressing the environmental health and safety of nanomaterials, pollution prevention in the production of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay in early intervention include “insufficient federal agency leadership, emphasis, and policy regarding proactive rather than reactive approaches to safer design.” If EPA intends to promote and guide early intervention in the design and production of emerging chemicals, materials, and products, the report states, “it will need to commit to this effort beyond its regulatory role.”
The International Zinc Association (IZA) prepared a response to a recent article entitled “Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption” and posted on the Proceedings of the National Academy of Sciences (PNAS) website. IZA states that while the article and related reports highlight that nano-zinc oxide improves crop productivity and zinc concentration in plants, they suggest that the concentration of zinc in plants is negative and poses potential risks to humans. According to IZA, “increased crop production and zinc concentration in plants is an encouraging result and one we would anticipate -- indeed, these are the two key objectives of adding zinc fertilizer to crops.” IZA notes that the appendix to the PNAS article states: “[I]ngesting 100g dry soybean mass from our study would deliver approximately 8mg Zn, which is well below the tolerable UIL for adults. Since children would consume less, as their protein requirements are less than adults, they should also not be at risk. Bioaccumulation levels would need to be approximately five times more total Zn than we report to reach bean Zn concentrations that are harmful to human health.” IZA states:
In conclusion, although we find the results of this study, specifically increased crop production and zinc uptake, to be very positive, we have great concern over the inappropriate interpretation of the these results. The risk of over-exposure to zinc in any capacity is negligible compared to the lifethreatening reality of underexposure to zinc -- which is far and away the bigger, more immediate danger. The misplaced concerns created by this report and the subsequent articles are capable of overshadowing the real problem of zinc deficiency in humans and crops, a serious global issue affecting food security and children’s lives.
The Proceedings of the National Academy of Sciences (PNAS) posted on its website on August 20, 2012, an article entitled “Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption.” According to the authors, no single study to date has examined the full implications of growing plants to full maturity in field soil contaminated by manufactured nanomaterials. The PNAS study does so for soybeans in farm soil amended with two metal oxide manufactured nanomaterials. The abstract states: “The results provide a clear, but unfortunate, view of what could arise over the long term: (i) for nano-ZnO, component metal was taken up and distributed throughout edible plant tissues; (ii) for nano-CeO2, plant growth and yield diminished, but also (iii) nitrogen fixation -- a major ecosystem service of leguminous crops -- was shut down at high nano-CeO2 concentration.” The authors conclude that, “[j]uxtaposed against widespread land application of wastewater treatment biosolids to food crops, these findings forewarn of agriculturally associated human and environmental risks from the accelerating use of” manufactured nanomaterials.
On August 1, 2012, the U.S. Environmental Protection Agency (EPA) posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states “is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials.” According to EPA, “[t]he complex properties of various nanomaterials make evaluating them in the abstract or with generalizations difficult if not impossible.” EPA notes that the case study does not represent a completed, or even preliminary, assessment of nanosilver. Instead, it and other similar case studies are intended to support research planning efforts for nanomaterials. The case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product lifecycle, transport, transformation and fate processes in environmental media, exposure-dose in receptors, and potential impacts in these receptors. If information is available, the case study also includes other direct and indirect ramifications of both primary and secondary substances or stressors associated with a nanomaterial. Through a structured collective judgment method, expert stakeholders used EPA’s draft case study to identify and prioritize research gaps that could inform future assessments and risk management efforts. Some of the research gaps pertain to nanosilver in disinfectant spray; others to nanosilver irrespective of its application, and still others to nanomaterials in general.
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.
EPA Nanomaterial Case Study Compares Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles
The U.S. Environmental Protection Agency (EPA) announced on July 2, 2012, the availability of an external review draft document entitled Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (EPA/600/R-12/043A). EPA states that the draft document “does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify what is known and unknown about MWCNT to support future assessment efforts.” On October 29, 2012, EPA will hold a public information exchange meeting to: (1) receive comments and questions on the draft document; and (2) provide information on the draft EPA nanomaterial case study and the workshop process that the draft document will be used in for identifying and prioritizing research gaps that could support future assessment and risk management efforts for MWCNT. Following the conclusion of the October 29 meeting, RTI International, an EPA contractor, will conduct a separate meeting on the “Nanomaterial Case Study Workshop Process: Identifying and Prioritizing Research for Multiwalled Carbon Nanotubes”' in the same location. EPA states that the workshop will be conducted independently by RTI International, with a set of invitee-only expert participants selected by RTI International, and will use a “structured decision science process” similar to the process used in previous workshops on nanoscale titanium dioxide in water treatment and in topical sunscreen and nanoscale silver in disinfectant spray. The RTI workshop will be open to public observers. Written comments on the draft document are due August 31, 2012. Registration for the public information exchange meeting will close on October 15, 2012. Space is limited, and reservations will be accepted on a first-come, first-served basis.
On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for fiscal year 2013 for 15 agencies with budgets dedicated to nanotechnology research and development (R&D).Continue Reading...
On February 17, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson will tour the Center for Environmental Implications of Nanotechnology (CEIN) at the University of California, Los Angeles. CEIN has been awarded a $24 million grant from EPA and the National Science Foundation, and is working to train the next generation of nano-scale scientists and engineers. According to EPA, CEIN is one of the nation’s only centers researching predictive toxicology of nanomaterials, and is developing a new approach to identify impacts and environmental hazards of nanomaterials before they become widely used in the environment. CEIN was established in September 2008 with the mission to ensure that nanotechnology is introduced in a responsible and environmentally compatible manner, thereby allowing the U.S. and international communities to leverage the benefits of nanotechnology for global economic and social benefit. CEIN is accomplishing this mission by developing a broad-based series of decision tools based on models of predictive toxicology and risk ranking premised on selected nanomaterial property-activity relationships that determine fate, transport, exposure, and biological injury mechanisms at cellular, tissue, organism, and population levels.
On February 9, 2012, the U.S. Environmental Protection Agency (EPA) posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the National Center for Environmental Assessment (NCEA) to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials. The basis of the workshop was the report Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray. According to the summary report, the outcomes of this and future workshops in the series -- prioritized information gaps and risk tradeoffs -- will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.Continue Reading...
The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products. To do this, the Project will: (1) examine full life cycles of nanomaterials in products; (2) work through specific release scenarios at key exposure points of the life cycle; (3) organize existing material characteristics data and measurement methods for those release scenarios; (4) develop a “state of the science” report for release measurement; and (5) carry out inter-laboratory testing to promote improvements, standardization, and widespread use of methods. The NanoRelease Project completed Phase 1 in 2011, resulting in the selection of multi-walled carbon nanotubes (MWCNT) in polymers as the first material to be evaluated through inter-laboratory studies of methods. In Phase 2, three Task Groups of more than 40 experts are evaluating: (1) measurement methods; (2) the effect of materials selected on release rates; and (3) identifying the key exposure/release scenarios. Each Task Group will produce a white paper on their respective topic. Phase 3 is scheduled to begin in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of MWCNT released from selected polymers. The NanoRelease Project is organized by Dr. Richard Canady of the ILSI Research Foundation, and is supported by the U.S. Environmental Protection Agency, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute.
The NanoBusiness Commercialization Association, North Carolina Department of Commerce, and Center of Innovation for Nanobiotechnology will co-host the Nanotech Commercialization Conference on April 4-5, 2012, in Research Triangle, North Carolina. Lynn L. Bergeson will speak at the Conference, which will include:
- National-level keynote speakers;
- Sessions, workshops, and exhibits showcasing the latest advances in the field;
- Discussions on financing, licensing, and business development geared toward the nanotech entrepreneur;
- Sessions and exhibits showcasing cutting-edge research, products, and technologies; and
- Networking opportunities with connected professionals.
On December 20, 2011, the National Institute of Standards and Technology (NIST) announced it issued the world’s first reference material for single-wall carbon nanotube soot. According to NIST, “nanotube-laden soot is the primary industrial source of single-wall carbon nanotubes, perhaps the archetype of all nanoscale materials.” NIST states that the new material “offers companies and researchers a badly needed source of uniform and well-characterized carbon nanotube soot for material comparisons, as well as chemical and toxicity analysis.” NIST certifies each unit of SRM 2483 for the mass fraction values of several common contaminants, including barium, cerium, chlorine, cobalt, dysprosium, europium, gadolinium, lanthanum, molybdenum, and samarium. NIST provides reference values (values believed to be accurate, but not rising to the level of confidence that NIST certifies) for an additional seven elements. NIST has also posted a material safety data sheet (MSDS) for the reference material.
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...
The U.S. Environmental Protection Agency (EPA) published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011.Continue Reading...
On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances. REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH. After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint. ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.
In an October 28, 2011, Federal Register notice, the National Cancer Institute’s (NCI) Alliance for Nanotechnology in Cancer announced the initiation of “Translation of Nanotechnology in Cancer” (TONIC), a public private industry partnership intended to promote translational research and development opportunities of nanotechnology-based cancer solutions. The notice states that an immediate consequence of this effort is the formation of a consortium involving government and pharmaceutical and biotechnology companies. The consortium will evaluate “promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients.” According to the notice, membership in the TONIC consortium will be limited to companies that: (1) have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval; and (2) are engaged in the development of nanotechnology-based formulations with application to imaging, diagnostics, and therapy.
On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human exposure assessment; (3) human health; (4) environment; (5) risk assessment and risk management methods; and (6) informatics and modeling. The Strategy also considers the ethical, legal, and societal implications (ELSI) of nanotechnology. NNI held a webinar on October 20, 2011, to announce the release of the Strategy, and Lynn L. Bergeson served on the panel. The Strategy, fact sheet, brochure, and webinar are available online. NNI will post the panelist materials.
On October 10, 2011, ACS Nano accepted an article entitled “Generation of Metal Nanoparticles from Silver and Copper Objects: Nanoparticle Dynamics on Surfaces and Potential Sources of Nanoparticles in the Environment,” in which the authors monitor nanoparticles and their transformations under a variety of environmental conditions. According to the authors, their studies reveal “unprecedented dynamic behavior” of silver nanoparticles on surfaces. The authors hypothesize that nanoparticle production occurs through a process involving three stages: (1) oxidation and dissolution of silver from the surface of the particle; (2) diffusion of silver ion across the surface in an adsorbed water layer; and (3) formation of new, smaller particles by chemical and/or photoreduction. The authors investigated non-nanoscale sources of silver, including wire, jewelry, and eating utensils placed in contact with surfaces, and found that they also formed new nanoparticles. According to the authors, copper objects display similar reactivity, suggesting that the phenomenon may be more general. The authors conclude that “discovery that [silver nanoparticles and copper nanoparticles] are generated spontaneously from manmade objects implies that humans have long been in direct contact with these nanomaterials and that macroscale objects represent a potential source of incidental nanoparticles in the environment.”
The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group, will serve as the moderator. Panelists will include:
- Dr. Treye Thomas, NEHI Working Group Co-Chair;
- Dr. Shaun Clancy, Evonik DeGussa Corporation;
- Dr. Janet Carter, Occupational Safety and Health Administration (OSHA); and
- Lynn L. Bergeson, Bergeson & Campbell, P.C.
The webinar will include a 20-minute question-and-answer segment following the presentations.
On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions.
Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, carbon nanotubes, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.” The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances.Continue Reading...
On September 18, 2011, Nature Nanotechnology posted an article entitled “Cell entry of one-dimensional nanomaterials occurs by tip recognition and rotation.” The authors state that materials with high aspect ratio, such as carbon nanotubes (CNT) and asbestos fibers, have been shown to cause length-dependent toxicity in certain cells because these long materials prevent complete ingestion, which frustrates the cell. The authors note that, while “[b]iophysical models have been proposed to explain how spheres and elliptical nanostructures enter cells,” one-dimensional nanomaterials have not been examined. The authors show “experimentally and theoretically” that cylindrical one-dimensional nanomaterials, such as CNTs, enter cells through the tip first. The abstract states:
For nanotubes with end caps or carbon shells at their tips, uptake involves tip recognition through receptor binding, rotation that is driven by asymmetric elastic strain at the tube-bilayer interface, and near-vertical entry. The precise angle of entry is governed by the relative timescales for tube rotation and receptor diffusion. Nanotubes without caps or shells on their tips show a different mode of membrane interaction, posing an interesting question as to whether modifying the tips of tubes may help avoid frustrated uptake by cells.
Earlier this month the Danish Environmental Protection Agency (DEPA) published a document entitled Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, which is intended to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials, and the possibility of exposure of humans and the environment. DEPA selected fullerenes, iron, silver, nanoclay, and titanium, cerium, and silicon dioxides for the project. Based on current uses, DEPA concluded that current applications of nano-iron and nano-clay cannot cause unexpected “nano-associated” health or environmental problems. Although DEPA identified no specific risk associated with current uses of any of the identified nanomaterials, it concluded “there are areas where there may be reason for attention and thus need for more knowledge.”
The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:
- Significant discussion about environmental, health, and safety (EHS) questions for nanotechnology-enabled products;
- Hands-on participation in joint programs of work that will better leverage resources; and
- Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.
The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk assessment criteria should be used to assess and minimize potential risks, which the EC states “would benefit those working in the building sector in particular, because it is estimated that nanomaterials will be used to develop 15% to 30% of facade coatings within the next 4 years.” The study is presented in the journal Environment International.
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...
On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”
Scientists Investigate Behavior of Metallic Silver Nanoparticles in a Pilot Wastewater Treatment Plant
Environmental Science & Technology posted on April 5, 2011, an article entitled “Behavior of Metallic Silver Nanoparticles in a Pilot Wastewater Treatment Plant.” The abstract states:
We investigated the behavior of metallic silver nanoparticles (Ag-NP) in a pilot wastewater treatment plant (WWTP) fed with municipal wastewater. The treatment plant consisted of a nonaerated and an aerated tank and a secondary clarifier. The average hydraulic retention time including the secondary clarifier was 1 day and the sludge age was 14 days. Ag-NP were spiked into the nonaerated tank and samples were collected from the aerated tank and from the effluent. Ag concentrations determined by inductively coupled plasma-mass spectrometry (ICP-MS) were in good agreement with predictions based on mass balance considerations. Transmission electron microscopy (TEM) analyses confirmed that nanoscale Ag particles were sorbed to wastewater biosolids, both in the sludge and in the effluent. Freely dispersed nanoscale Ag particles were only observed in the effluent during the initial pulse spike. X-ray absorption spectroscopy (XAS) measurements indicated that most Ag in the sludge and in the effluent was present as Ag2S. Results from batch experiments suggested that Ag-NP transformation to Ag2S occur[r]ed in the nonaerated tank within less than 2 h. Physical and chemical transformations of Ag-NP in WWTPs control the fate, the transport and also the toxicity and the bioavailability of Ag-NP and therefore must be considered in future risk assessments.
Inhalation Toxicology has published an article entitled “Exposure assessment of workplace manufacturing nanosized TiO2 and silver,” which monitored the possible exposure to nanoparticles at workplaces that manufacture nano-titanium dioxide (TiO2) and nano-silver. The abstract states:
To estimate the potential exposure of workers, personal sampling, area monitoring, and real-time monitoring using a scanning mobility particle sizer (SMPS) and dust monitor were conducted at workplaces where the workers handle nanomaterials. The gravimetric concentrations of TiO2 ranged from 0.10 to 4.99 mg/m3, which were lower than the occupational exposure limit 10 mg/m3 set by the Korean Ministry of Labor or American Conference of Governmental Industrial Hygienists (ACGIH). Meanwhile, the silver metal concentrations ranged from 0.00002 to 0.00118 mg/m3, which were also lower than the silver dust 0.1 mg/m3 and silver soluble compound 0.01 mg/m3 occupational exposure limits set by the ACGIH. The particle number concentrations at the nano-TiO2 manufacturing workplaces ranged from 11,418 to 45,889 particles/cm3 with a size range of 15-710.5 nm during the reaction, although the concentration decreased to 14,000 particles/cm3 when the reaction was stopped. The particle concentrations at the TiO2 manufacturing workplaces increased during the reactor and vacuum pump operations, and during the collection of the synthesized TiO2 particles. Similarly, the particle concentrations at the silver nanoparticle manufacturing workplaces increased when the sodium citrates were weighed or reacted with the silver nitrates, and during the cleaning of the workplace. The number of silver nanoparticles in the samples obtained from the workplace manufacturing silver nanoparticles using induced coupled plasma ranged from 57,789 to 2,373,309 particles/cm3 inside the reactor with an average size of 20-30 nm and 535-25,022 particles/cm3 with a wide range of particle sizes due to agglomeration or aggregation after the release of nanoparticles into the workplace air. In contrast, the silver nanoparticles manufactured by the wet method ranged from 393 to 3526 particle[s]/cm3 with an average size of 50 nm. Thus, when taken together, the TiO2 and silver nanoparticle concentrations were relatively lower than existing occupational exposure limits.
On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses included:
- Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
- Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
- Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
- Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
- Mr. William Moffitt, President and Chief Executive Officer, Nanosphere, Inc.
The witnesses emphasized the need for Congress to reauthorize the National Nanotechnology Initiative (NNI) to ensure that the U.S. remains the global leader in nanotechnology. Other countries, such as Japan, China, and South Korea, have increased their investment in nanotechnology. Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his service as Director of the NNCO. Dr. Teague’s last day will be April 15, 2011.
On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”
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 February 17, 2011, the U.S. Environmental Protection Agency (EPA) announced that it awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA states that, in collaboration with the United Kingdom's (UK) Natural Environment Research Council, it is leading this scientific research effort to understand better the potential risks to people’s health and the environment. The grants EPA awarded are intended to help researchers determine whether certain nanomaterials can leach out of products such as paints, plastics, and fabrics when they are used or disposed of and whether they could become toxic to people and the environment. According to EPA, the U.S. Consumer Product Safety Commission (CPSC) has also contributed $500,000 through a new research partnership between the two agencies. Grant awards were made to three consortia consisting of researchers from the U.S. and the UK Each U.S. team of researchers received $2 million from EPA and CPSC, for a total of $6 million. Each UK team will also receive $2 million from the UK agencies, resulting in a grand total of $12 million to conduct the research.
On February 14, 2011, the Joint Research Centre (JRC) announced the creation of the first European repository of nanomaterials. According to JRC, the repository contains most types of nanomaterials that are currently assumed to be used in significant volumes in consumer products. The materials will be used as a reference point by laboratories that carry out safety assessments on nanomaterials, to make sure that their results are comparable to those of other laboratories. JRC states that this responds to a need expressed by experts in international standardization organizations. The new repository includes, among other materials, carbon nanotubes, silver nanoparticles, titanium dioxide, cerium oxide, zinc oxide, bentonite, gold, and silicon dioxide.
Under the fiscal year (FY) 2012 budget request submitted by President Obama to Congress on February 14, 2011, funding for the National Nanotechnology Initiative (NNI) would increase by $201 million, to $2.1 billion. According to an Office of Science and Technology Policy (OSTP) fact sheet, agencies participating in the NNI have developed three signature initiatives in areas ready for advances through close and targeted program-level interagency collaboration: Nanoelectronics for 2020 and Beyond; Sustainable Manufacturing: Creating the Industries of the Future; and Nanotechnology for Solar Energy Collection and Conversion. Participating agencies will continue to support nanoscience and nanotechnology development through investigator-led research; multidisciplinary centers of excellence; education and training; and infrastructure and standards development. In addition, OSTP states, agencies will still maintain a focus on the responsible development of nanotechnology, with attention to potential human and environmental health impacts, as well as ethical, legal, and other societal issues. At a February 14, 2011, news briefing for reporters, OSTP Director John Holdren said budget reductions proposed by Republicans in Congress could be damaging if applied to federal research funding.
This week the National Nanotechnology Initiative (NNI) and the White House Office of Science and Technology Policy (OSTP) released the 2011 NNI Strategic Plan. According to NNI, the Plan retains the “overall vision,” four goals, and eight program component areas outlined in the previous edition of the Plan, which was released in December 2007. For the first time, the Plan includes specific objectives under each goal, outlining concrete steps that NNI member agencies will take toward collectively achieving the NNI vision and goals. NNI member agencies will use the Plan to guide the coordination of their research, training programs, and resources. NNI states that the Plan incorporates a broad rage of stakeholder input obtained through NNI-sponsored workshops, a formal Request for Information published in the Federal Register, and the NNI Strategy Portal website.
On January 31, 2011, State Secretary for Infrastructure and the Environment, Joop Atsma, announced that joint investments in the development of nanotechnology made by the public and private sectors in the Netherlands must devote at least 15 percent of the investment to risk analyses. According to a spokesperson, the new requirement includes an €80 million ($110.4 million) investment approved by the previous government and matched by the private sector. The independent Committee for Societal Dialogue on Nanotechnology recently released a report that found citizens have a positive attitude about the opportunities offered by nanotechnology, but are concerned about the risks.
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.”
The Hohenstein Institute announced on January 10, 2011, that it completed a field study of the effect of antibacterial clothing containing nanosilver on skin flora and microclimate. According to the Institute, natural skin flora were unaffected, even after long periods of wear. A total of 60 healthy volunteers participated in the six-week study. Special t-shirts were made for the study, with an antibacterial treatment on one side (verum), while the other half served as a non-antibacterial placebo. Researchers found that the skin flora and microclimate of healthy skin remained unaffected by the antibacterial t-shirts that were worn next to the skin: no damage to the skin flora could be detected, i.e. no change to the total number of bacteria on the skin or variation in the range of bacteria. The researchers concluded that the antibacterial textiles could, therefore, be classified as safe. The researchers noted that, nevertheless, the antibacterial textiles are effective against bacteria entering the fabric in perspiration, as shown in previous studies. The researchers intend to submit their data for publication in an internationally regarded specialist dermatology journal.
The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:
- Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
- Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials. According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
- Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.
On December 21, 2010, the California Department of Toxic Substances Control (CDTSC) issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. According to CDTSC, Health and Safety Code Section 57018(a)(4) defines a “manufacturer” as a “person who produces a chemical in this state or imports a chemical into this state for sale in this state.” Accordingly, CDTSC states, “persons and businesses who produce or import one or more of the above chemicals, in any quantity, must comply with the statute and this request.” CDTSC requests information about the analytical test methods that identify and quantify the specified nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. CDTSC states it determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists. To better understand the behavior, fate, and transport of these nanomaterials, CDTSC needs “appropriate analytical test methods” for manufacturers, contract and reference laboratories, and regulatory agencies. CDTSC states that manufacturers “may be required to develop information consistent with the requirements of Health and Safety Code section 57019(c) and (d).” Manufacturers, including importers, must provide the requested information no later than one year from CDTSC’s December 21, 2010, letter, however, “timely attention and response is preferred.”
EPA Will Hold Public Information Exchange on Nanomaterial Case Studies and Workshop on Nanoscale Silver
The U.S. Environmental Protection Agency (EPA) announced in a December 13, 2010, Federal Register notice that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials. Registration is required to attend the meeting, and EPA states that space is limited. Comments may be submitted in writing or made orally during the meeting. Written comments are due December 28, 2010. EPA intends to consider all such comments in evaluating whether or how to develop further case studies and workshops on nanomaterials. To date, EPA has published two Nanomaterial Case Studies -- Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen (Final), and Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft).Continue Reading...
The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy (Strategy). The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision. It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision. It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods) and evaluates the state of the science for each of these topics. The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area. The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.
On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials:
- Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories -- OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.”
- List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision -- OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles.
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 Nanotechnology Initiative (NNI) draft Strategic Plan is available for comment until November 30, 2010. The Strategic Plan is the framework that underpins the work of the 25 NNI member agencies. The Strategic Plan is intended to ensure that advances in nanotechnology research and development (R&D) and their applications to agency missions and the broader national interest continue. The purpose of the Strategic Plan is to facilitate achievement of the NNI vision by providing guidance for agency leaders, program managers, and the research community regarding planning and implementation of nanotechnology R&D investments and activities.
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 International Journal of Occupational and Environmental Health (IJOEH) has posted a special issue concerning human and environmental exposure assessment for nanomaterials. The issue includes articles such as “Understanding Workplace Processes and Factors that Determine Exposures to Engineered Nanomaterials,” “Nanotechnology and Exposure Science: What Is Needed to Fill the Research and Data Gaps for Consumer Products,” “Imaging and Characterization of Engineered Nanoparticles in Sunscreens by Electron Microscopy, under Wet and Dry Conditions,” and “Exposure Assessment: Recommendations for Nanotechnology-Based Pesticides.”Continue Reading...
In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science. NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000. According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle: Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.”
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 September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA’s efforts related to CNTs. The candidate chemicals for CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions.
The California Department of Toxic Substances Control (CDTSC) has rescheduled its workshop on state and federal nanomaterial activities for September 22, 2010. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. The workshop is open to the public.
The August 2010 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with the National Toxicology Program (NTP), labs in the NIEHS intramural program, and the U.S. Environmental Protection Agency (EPA) as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere. The team will study the effects in cells tissue, animals, and human subjects. The research team will test the hypothesis that selected engineered nanomaterials induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:
- Exposing human bronchial epithelia and alveolar macrophages -- native lungs cells donated by healthy volunteers -- to ENMs ex vivo to evaluate inflammation and cell toxicity;
- Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
- Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.
On June 8, 2010, the Organization for Economic Cooperation and Development (OECD) announced the publication of two materials for use in the OECD Sponsorship Programme. The first is a revision of the Guidance Manual for the Testing of Manufactured Nanomaterials. According to OECD, the revised Guidance “is intended to support the testing undertaken in the context of OECD’S Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate, and consistent.” OECD states that the second document, entitled Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, was published to assist the sponsors of the OECD Sponsorship Program, as well as to help others involved in the safety testing of manufactured nanomaterials.
The President’s Council of Advisors on Science and Technology (PCAST) seeks comment from stakeholders on how the federal government can best use its resources so three of the “newest and most promising technologies,” including nanotechnology, “provide the greatest economic benefits to society.” The President’s Innovation and Technology Advisory Committee (PITAC), which is part of PCAST, is soliciting information and ideas from stakeholders -- including the research community, the private sector, universities, national laboratories, state and local governments, foundations, and nonprofit organizations -- regarding the “Golden Triangle.” Each side of the Golden Triangle represents one of three areas of research that together are transforming the technology landscape today: information technology, biotechnology, and nanotechnology.Continue Reading...
On May 28, 2010, the House passed, by a vote of 262-150, the America COMPETES Reauthorization Act of 2010 (H.R. 5116), which would authorize funding for the National Nanotechnology Initiative (NNI), as well as the National Science Foundation (NSF), National Institute of Standards and Technology (NIST), and Department of Energy (DOE) Office of Science activities. The bill includes language from H.R. 554, the NNI Amendments Act of 2009, which the House passed in February 2009. H.R. 5116 would require NNI to work toward developing “standards related to methods and procedures for detecting, measuring, monitoring, sampling, and testing engineered nanoscale materials for environmental, health, and safety impacts.” The bill would fund research on “green nanotechnology” by creating research centers that would focus on methods and approaches to develop environmentally benign nanoscale products and nanoscale manufacturing processes; foster the transfer of the results of such research to industry; and provide for the education of scientists and engineers through interdisciplinary studies in the principles and techniques for the design and development of environmentally benign nanoscale products and processes. The bill would create a position, within the Office of Science and Technology Policy (OSTP), for a Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would ensure that a research plan for the environmental, health, and safety (EHS) research activities is developed, updated, and implemented.
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.
In a February 15, 2010, article entitled “ZnO Particulate Matter Requires Cell Contact for Toxicity in Human Colon Cancer Cells,” researchers report their results of a comparison of the toxicity of two commercial types of zinc oxide (ZnO) to colon cells. According to the researchers, the nano-sized ZnO was more cytotoxic than micrometer-sized ZnO. The researchers state: “Unintended exposure to nano-sized zinc oxide from children accidentally eating sunscreen products is a typical public concern, motivating the study of the effects of nanomaterials in the colon.” The article will be published in Chemical Research in Toxicology.
On April 5, 2010, the U.S. Environmental Protection Agency (EPA) announced that its Small Business Innovation Research (SBIR) Program awarded $2.38 million to 34 small businesses to develop “innovative, sustainable technologies to protect human health and the environment.” The awards focus on the following environmental research areas: increasing the efficiency of green building materials and systems; manufacturing innovation; prevention, monitoring, and control using nanotechnology; reducing greenhouse gases; new treatment technologies for drinking water; improving water infrastructure; reducing emissions from small air pollution sources and vehicles and biofuels production facilities; new approaches for cleaning up and monitoring hazardous waste sites; and new tools for homeland security systems. Examples of new technologies include NEI Corporation, which will develop a “self-healing nanocomposite to protect drinking water pipes from corrosion.” EPA is also requesting applications for the development of new environmental technologies. Applications are due May 11, 2010.
On March 4, 2010, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) Program announced a partnership led by the DfE Program and Office of Research and Development (ORD). The partnership is conducting a screening-level life-cycle assessment of currently manufactured lithium-ion battery technologies and a next generation battery component that uses single-wall carbon nanotube technology. According to the DfE Program, the partnership offers the opportunity to mitigate current and future impacts and risks by helping battery manufacturers and suppliers identify materials and/or processes associated with the greatest environmental impacts throughout the life cycle of their products, and identify areas that could benefit from increased energy efficiency.
American Academy of Dermatology Annual Meeting Includes Presentation on Nanotechnology in Cosmetic Products
During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products, and perfumes. Nanoparticles used in sunscreens increase protection and coverage on the skin, while being less visible than microparticles. In anti-aging products, nanotechnology may allow active ingredients to penetrate the top layer of the skin. Researchers are currently exploring nanoparticle treatments of conditions such as melanoma. Dr. Nasir noted, however, that dermatologists are concerned about the potential health risks posed by nanotechnology, and “anxiously await” the Food and Drug Administration’s review of the safety of nanoparticles.
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 October 23, 2009, EHP-in-Press posted an article entitled “Evaluation of Silver Nanoparticle Toxicity in vivo Skin and in vitro Keratinocytes,” which assesses the potential cytotoxicity of silver nanoparticles in human epidermal keratinocytes, and their inflammatory and penetrating potential into porcine skin in vivo. According to the article, silver nanoparticles are non-toxic when dosed in washed silver nanoparticle solutions or carbon-coated. The authors conclude that their study “provides a better understanding [of silver nanoparticles] safety in vitro as well as in vivo and a basis for occupational and risk assessment.” EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.
On September 30, 2009, the U.S. Environmental Protection Agency (EPA) announced the availability of the Nanomaterial Research Strategy (Strategy), which EPA describes as its new research strategy to understand better how manufactured nanomaterials may harm human health and the environment. The Strategy outlines what research EPA intends to support over the next several years to generate information about the safe use of nanotechnology and products that contain nanoscale materials. The Strategy also includes research into ways nanotechnology can be used to clean up toxic chemicals in the environment. In its announcement, EPA states that its role among federal agencies “is to determine the potential hazards of nanotechnology and develop approaches to reduce or minimize any risks identified. As part of the strategy, researchers are investigating widely used nanomaterials, such as carbon nanotubes, which are used in vehicles, sports equipment and electronics; and titanium dioxide, which is used in paints, cosmetics and sunscreens.”
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 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 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...
On July 29, 2009, Particle and Fibre Toxicology posted an article entitled “Maternal Exposure to Nanoparticulate Titanium Dioxide During the Prenatal Period Alters Gene Expression Related to Brain Development in the Mouse.” The purpose of the study was to investigate the effects of maternal exposure to nano-sized anatase titanium dioxide on gene expression in the brain during the developmental period. According to the authors, analysis of gene expression indicated that expression levels of genes associated with apoptosis were altered in the brain of newborn pups, and those associated with brain development were altered in early age. Genes associated with response to oxidative stress were changed in the brains of two- and three-week old mice. The authors concluded that maternal exposure of mice to titanium dioxide nanoparticles “may affect the expression of genes related to the development and function of the central nervous system.” A July 17, 2009, ACS Nano article entitled “Cellular Toxicity of TiO2-Based Nanofilaments” concludes that titanium dioxide-based nanofilaments “are cytotoxic and thus precautions should be taken during their manipulation.” The authors studied the cellular toxicity of titanium dioxide-based nanofilaments in relation to their morphology and surface chemistry.