Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

EDF obtained a redacted copy of the consent order, and provides the following summary of the requirements:

• Conduct a 90-day inhalation toxicity test in rats;
• Supply EPA with a one-gram sample of its MWCNTs and its Material Safety Data Sheet;
• Submit certain characterization data within six months after commencing full manufacture;
• Require its workers to wear protective gloves and clothing shown to be impermeable and National Institute for Occupational Safety and Health (NIOSH)-approved respirators;
• Use the substance only for a particular use, claimed confidential but generically identified as a “property modifier” in electronics and polymer composites; and
• Provide the nanomaterial only to entities that agree to the same use restrictions and worker protection conditions.

• Shvedova, et al., “Inhalation Versus Aspiration of Single Walled Carbon Nanotubes in C57BL/6 Mice: Inflammation, Fibrosis, Oxidative Stress and Mutagenesis” -- Mice that inhaled carbon nanotubes from an aerosol suspended in the air showed the same dose-related effects as mice that were exposed in past studies through a different method, the direct aspiration of carbon nanotubes into the lung.  Effects included the formation of granulomas in the lungs of exposed mice, and lung tissue fibrosis.  Due to the lack of workplace exposure data, scientists are unable at present to predict whether workers would experience similar effects through workplace exposures, or whether the effects would signal a risk for impairment or death, either in and of themselves or as precursors to other effects.
• Rengasamy, et al., “Filtration Performance of NIOSH-Approved N95 and P100 Filtering Facepiece Respirators Against 4 to 30 Nanometer-Size Nanoparticles” -- Evaluations of NIOSH-approved N95 and P100 filtering-facepiece respirators for reducing exposures to nanometer-sized silver aerosol particles supported previous studies that found that such respirators should provide expected levels of protection against nanoparticles, when fitted, maintained, and used properly.
• The International Alliance for NanoEHS Harmonization (IANH) -- Four NIOSH researchers representing combined interdisciplinary expertise in laboratory and field studies are part of IANH, a new international research partnership.  IANH intends to establish scientific protocols to promote harmonization in the toxicological testing of nanomaterials.
• Organization for Economic Cooperation and Development (OECD) Workshop -- NIOSH is leading the formation of an October 20, 2008, workshop on the assessment and mitigation of workplace exposures to nanomaterials.  During the workshop, representatives of the OECD Working Party on Manufactured Nanomaterials and invited outside experts will explore the latest developments, needs, and opportunities in research.
• The Richard C. Knudson Publication Award, 2008 -- The American Biological Safety Association presented this award to Vladimir V. Murashov, Ph.D., Special Assistant to the Director, NIOSH, and John Howard, M.D., former Director of NIOSH, for the paper “Biosafety, Occupational Health, and Nanotechnology.”  The award recognizes “significant contributions in areas of scientific investigation and/or health and safety.”

• Nanotechnology Field Research Team Update: NIOSH conducted site visits to facilities involved in the research, manufacture, or use of various types of nanomaterials. NIOSH is using the information it obtained to develop workplace guidance documents to protect nanotechnology workers from occupational injury and illness. NIOSH states that it learned that:

• Basic particle counting and sizing instruments can be used to identify emissions from nanomaterial processes;
• Careful interpretation of the particle data is needed to differentiate between incidental (background) and process-related nanoparticles; and
• Engineering controls do minimize workplace exposure to engineered nanoparticles.

NIOSH encourages companies interested in receiving a visit by the Field Research Team to contact it. All site visits are initiated by the respective companies and are completely voluntary.

• NIOSH Nanotechnology Field Research Effort Fact Sheet: NIOSH created a Field Research Team to assess workplace processes, materials, and control technologies associated with nanotechnology and to conduct on-site assessments of potential occupational exposure to a variety of nanomaterials. Through this effort, NIOSH intends to gather baseline data to assist in determining potential occupational safety and health implications of exposure to engineered nanomaterials and developing guidance to ensure safe working conditions. Participation is open to research laboratories, producers, and manufacturers working with engineered nanomaterials. NIOSH states that the data collected by the field research team will be communicated back to the participant.  NIOSH may then use the data in a general manner to update its guidance on occupational safety and health implications of exposure to nanomaterials, and make it available in technical documents, scientific presentations, or on the NIOSH website.  NIOSH will not identify participants in any documents that are disseminated publicly without their permission.

• NIOSH Nanotechnology Metal Oxide Particle Exposure Assessment Study: As part of its nanotechnology research agenda, NIOSH initiated a study to investigate exposure to fine (0.1 µm to 2.5 µm diameter) and ultrafine (<0.1 µm diameter) metal oxides.  NIOSH specifically designed the study to conduct a detailed evaluation of exposures to fine and ultrafine metal oxides, and is not the same as the baseline assessment program offered by the NIOSH Nanotechnology Field Research Team.  NIOSH asks manufacturers and end-users of fine and ultrafine metal oxides to participate in this study.  NIOSH states: “More specifically, workers at these facilities who are involved in the production and use of metal oxides will be asked to participate.” According to NIOSH, participants will benefit because NIOSH’s sampling results “may provide companies with a better understanding of metal oxide exposure occurring in their facility.  Areas of contamination, if any, will be identified and recommendations to reduce exposure will be provided when possible.  A report of the findings will be sent to each company that participates.” NIOSH will use the data to determine the extent to which metal oxide exposure is occurring in the nanotechnology industry.  NIOSH states: “The information will be used for scientific research purposes only, and published study results will not identify participating companies.”

The goals for NIOSH nanotechnology research are as follows:

1. Determine if nanoparticles and nanomaterials pose risks for work-related injuries and illnesses;
2. Conduct research to prevent work-related injuries and illnesses by applying nanotechnology products;
3. Promote healthy workplaces through interventions, recommendations, and capacity building; and
4. Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.

The NIOSH Nanotechnology Research Center (NTRC) identified ten critical research areas that will be used to address the strategic goals:

1. Exposure assessment;
2. Toxicity and internal dose;
3. Epidemiology and surveillance;
4. Risk assessment;
5. Measurement methods;
6. Engineering controls and personal protective equipment;
7. Fire and explosion safety;
8. Recommendations and guidance;
9. Communication and information; and
10. Applications.

The NTRC efforts are organized according to the ten critical research areas.  NIOSH will identify and characterize hazards, assess exposure, characterize risk, and develop risk management guidance through targeted research in each of the critical areas.

According to the December 12, 2007, Federal Register notice, during the meeting, NIOSH will place special emphasis on discussion of the following:

1. Do the data support the conclusions of the document?
2. Are the conclusions appropriate in light of the current understanding of toxicological data?
3. Is medical surveillance appropriate at this time for workers with potential exposure to engineered nanoparticles; if so, what form(s) of medical surveillance are specific for such workers?
4. What are the potential benefits, adverse impacts, and limitations of medical screening of workers potentially exposed to engineered nanoparticles?
5. What are the potential benefits, adverse impacts, and limitations of establishing an exposure registry for workers exposed to engineered nanoparticles?

The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:

• Purpose:  Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
• Current Understanding:  The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications.  As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
• Information Development:  Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment.  To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
• Risk Assessment and Risk Management:  The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation.  As experience is gained, these approaches can be refined.  The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
• International:  Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation.  The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community.  The federal government should also promote access to information across the international community.  These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
• Regulatory Path Forward:  In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
  • Regulation should focus where need exists and where scientific information supports action (e.g., targeted to specific groups and classes of materials instead of a “one-size-fits-all” approach);
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
  • Where possible, regulatory approaches should enable rather than hinder innovation;
  • Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
  • Benefits of regulation should justify their costs;
  • Regulations should be developed in an open and transparent manner; and
  • Regulations and guidance should consider established requirements and guidance such as the following:
    • Executive Order (EO) 12866 -- Regulatory Planning and Review (Oct. 4, 1993);
    • Information Quality Act and Information Quality Guidelines: OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002);
    • National Technology Transfer and Advancement Act of 1995;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (Feb. 10, 1998);
    • OMB Final Information Quality Bulletin for Peer Review (Dec. 16, 2004);
    • OMB Final Bulletin for Agency Good Guidance Practices (Jan. 18, 2007); and
    • OMB/OSTP Memorandum:  Updated Principles for Risk Analysis (Sept. 19, 2007).

NTRC’s goals, and progress made toward each, include:

• Determine if nanoparticles and nanomaterials pose risks for work-related injuries and illnesses.

NTRC has conducted toxicology research on the properties and characteristics of nanoparticles that are relevant for predicting adverse health effects.  To gain further knowledge about exposure and control practices, NTRC established a field team to conduct assessments of workplaces where exposure to engineered nanoparticles may occur.  To date, this team has partnered with various companies that produce or use engineered nanoparticles to obtain information on potential worker exposures, control technologies, and risk management practices.

• Conduct research on the application of nanotechnology for the prevention of work-related injuries and illnesses.

NTRC has identified various possibilities for applying nanotechnology to occupational safety and health, including its application in fabricating more efficient filters, sensors, and protective clothing.  NTRC has also conducted numerous discussions with academia and the private sector on other potential projects.  Efforts are underway between NTRC, other Centers for Disease Control and Protection (CDC) personnel, and the Georgia Institute of Technology to identify collaborative projects involving nanotechnology applications to occupational and public health problems.

• Promote healthy workplaces through interventions, recommendations, and capacity building.

NTRC provided guidance for workers and employers in a document entitled Approaches to Safe Nanotechnology:  An Information Exchange with NIOSH.  Other information products on the NIOSH website include the nanotechnology topic page (with an extensive selection of frequently asked questions) and the Nanoparticle Information Library (NIL), which is a resource on particle information including physical and chemical characteristics.  In addition, NTRC convened a cross-federal group to develop a framework document for health surveillance of workers exposed to nanomaterials.  According to NTRC, this document will involve the business community to identify the range of issues involved in occupational health surveillance.

• Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.

NTRC established several national and international collaborations to advance understanding of occupational safety and health for nanotechnology workers.  NTRC participates in the National Nanotechnology Initiative (NNI) and has contributed to the nanotechnology strategic plan through the working group on Nanotechnology Environmental and Health Implications (NEHI).  Occupational safety and health has been a major priority of the NEHI effort, and NIOSH’s strategic research plan and activities address most of the major issues in the NEHI plan. NTRC collaborated with the Organization for Economic Cooperation and Development (OECD) to build cooperation, coordination, and communication between the U.S. and 30 OECD member countries, including the European Union (EU), and with more than 180 nonmember economies, as well.  NTRC is part of the U.S. leadership on the International Organization for Standardization (ISO) TC 229 Nanotechnology Working Group on Health, Safety, and the Environment.  NTRC also works with the World Health Organization (WHO) Collaborating Centers on global projects of information dissemination and communication.