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

On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research.

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On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:

Principles Document:

• Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials

Regulatory Documents:

• Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
• Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
• Guidance for Handling and Use of Nanomaterials at the Workplace
• Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
• Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials

Documents on Safety Research:

• Roadmap for Safety Research on Nanomaterials
• Environmental Aspects of Nanoparticles

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On April 9, 2008, the Project on Emerging Nanotechnologies (PEN) released a report entitled Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology. According to the report, because of the slow pace of federal action to regulate development of nanotechnology, “there is ‘room at the bottom’ for state and local governments to move forward in pursuing regulatory and other oversight options.” Research for the report identified a number of states with laws promoting the nanotechnology industry or other initiatives encouraging research and development on nanotechnology applications. The report states that each of the 50 states is “home to at least one company, university, government laboratory, or other type of organization working with nanomaterials.”

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A recent report released by Friends of the Earth (FOE) calls for a moratorium “on the further commercial release of food products, food packaging, food contact materials and agrochemicals that contain manufactured nanomaterials until nanotechnology-specific safety laws are established and the public is involved in decision making.” The report, entitled Out of the Laboratory and on to Our Plates:  Nanotechnology in Food & Agriculture, lists 104 commercially available foods, nutritional supplements, food contact materials, and agricultural chemicals identified by FOE that contain manufactured nanomaterials.  According to FOE, due to the “reluctance of food manufacturers to discuss their use of nanotechnology,” this list likely “represents only a small fraction of commercially available products that contain nanomaterials.” FOE states that many more nanofood products are in development, and many of the world’s largest food companies are exploring nanotechnology for food processing and packaging.  Many of the world’s largest agrochemicals and seed companies also have active nanotechnology research and development programs. FOE claims that regulations in the U.S., Europe, and Australia fail to address nanomaterials and calls for nano-specific food regulation to ensure food safety.

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Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson and Ira Dassa published an article appearing in the Fall 2007 issue of Sustainable Development Law and Policy. The article discusses several issues in connection with the application of the Toxic Substances Control Act (TSCA) to engineered nanoscale materials.

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On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.”

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On January 2, 2008, the National Nanotechnology Initiative (NNI) released its Strategic Plan, which describes NNI’s investment strategy and the program component areas called for by the 21st Century Nanotechnology Research and Development Act of 2003. Under the Act, NNI must update its Strategic Plan every three years, and this plan updates and replaces the December 2004 plan. The Strategic Plan outlines the goals and priorities of NNI and describes approaches for achieving them. NNI states that the Plan supports “leading edge research, sustains the extensive infrastructure of facilities, seeks to facilitate technology transfer, and addresses environmental, health, and societal concerns.”

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The U.S. Environmental Protection Agency’s (EPA) December 10, 2007, Unified Agenda includes a notice regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On July 12, 2007, EPA announced the availability of an NMSP concept paper, a proposed information collection request (ICR), and a paper that describes determining the TSCA Inventory status of nanoscale materials. According to the Unified Agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents.

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On December 4, 2007, the Organization for Economic Cooperation and Development (OECD) posted a notice entitled “Testing a Representative Set of Nanomaterials -- The Launch of a Sponsorship Programme.” OECD states that its Working Party on Manufactured Nanomaterials has launched a sponsorship program in which countries will share the testing of specific nanomaterials. According to OECD, valuable information on the safety of manufactured nanomaterials can be derived by testing a representative set for human health and environmental safety. In launching the sponsorship program, the Working Party agreed to a priority list of manufactured nanomaterials for testing, based on materials which are in or close to commerce, as well as a list of endpoints for which they should be tested. OECD intends to make regular updates on this program.

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On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.”

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On October 31, 2007, the House Committee on Science and Technology’s Research and Science Education Subcommittee held a hearing on the relationship between environmental and health policy and nanotechnology. The Subcommittee examined how the U.S. can stay at the forefront of scientific research and development, while at the same time establishing priorities and a detailed plan for research on the potential environmental and health risks of engineered nanomaterials. The Science and Technology Committee held two previous hearings on this issue -- one in 2005 and another in 2006 -- with the objective of reviewing the importance of risk research for achieving the potential benefits of nanotechnology and the efforts of the interagency National Nanotechnology Initiative (NNI) to put in place a research strategy. Progress in developing the research strategy has been slow, however. The hearing explored the status of the planning efforts and received suggestions from outside witnesses on ways to improve the process.

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The Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted on October 9, 2007, a seminar on the Responsible NanoCode, a voluntary, principles-based Code of Conduct for entities involved in the research, development, manufacture, and retail sale of products using nanotechnologies. The draft Code was developed by a working group organized in late 2006 by The Royal Society, the United Kingdom’s (UK) national academy of science, in conjunction with Insight Investment, the Nanotechnology Industries Association (NIA), and the UK government-sponsored Nanotechnology Knowledge Transfer Network.

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On October 3, 2007, the California Department for Toxic Substances Control (DTSC) held a symposium on the potential hazards of nanoparticles in the environment. According to DTSC, exploring environmentally safe processes in nanotechnology manufacturing is a component of the California Green Chemistry Initiative.  Under the Initiative, a multi-agency state team is exploring a different approach to environmental protection -- transitioning away from managing toxic chemicals at the end of the life-cycle, to reducing or eliminating their use altogether.  DTSC states that this new approach is similar to measures adopted by the European Union (EU) and the Canadian government to encourage greater manufacturer responsibility.

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The European Commission (EC) Directorate General for Health and Consumer Protection retained GreenFacts to summarize the EC’s 2006 report entitled Modified Opinion (After Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies. According to GreenFacts, the EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) wrote its Opinion for a scientific audience. GreenFacts prepared its summary for a broader audience.

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The California Department of Toxic Substances Control (CDTSC) will hold a symposium entitled “Nanotechnology Symposium II:  Potential Hazards of Nanomaterials in the Environment” on October 3, 2007. The draft agenda includes the following topics: 

• Chemical Properties and Commercial/Industrial Applications of Nanotechnology;
• Physico-Chemical Characterization of Nanoparticles and Its Relation to Their Bio-Interactions;
• Potential Ecotoxicity of Nanoparticles Released to the Environment;
• Nanomaterial Human Health Risks and Risk Assessment; and
• One Proactive Approach to Responsible Nanotechnology Development:  The DuPont -- Environmental Defense NanoRisk Framework.

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On August 16, 2007, the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007.

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On August 1, 2007, the Nanoethics Group announced the release of a collection of papers entitled Nanoethics: The Ethical and Social Implications of Nanotechnology, which addresses issues related to nanotechnology’s impact on society. The anthology includes papers from nearly 40 experts worldwide and includes topics related to benefits, risk, environment, health, human enhancement, privacy, military, democracy, education, humanitarianism, molecular manufacturing, space exploration, artificial intelligence, life extension, and more.

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On July 31, 2007, an international coalition of consumer, public health, environmental, and labor organizations issued the Principles for the Oversight of Nanotechnologies and Nanomaterials and called for strong, comprehensive oversight of the new technology and its products. According to the coalition, the manufacture of products using technology has “exploded in recent years,” while “evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards.”

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The Council of State and Territorial Epidemiologists (CSTE) recently issued a position statement on nanotechnology risks. The CSTE statement observes that the “health, safety and environmental effects of nanomaterials are poorly understood,” and that “our limited knowledge of [nanotechnology’s] potential harm is cause for concern.” Among other things, CSTE calls: for increased funding for research on the environmental, health, and safety impacts of nanotechnology; for the Food and Drug Administration (FDA) to require content-labeling on products containing nanoparticles that are aerosolized or applied to the skin; and for the U.S. Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) to issue standards for the protection of workers, the public, and the environment against known or suspected harmful effects of nanoparticles.

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On June 22, 2007, the U.S. Environmental Protection Agency (EPA) announced the award of two research grants totaling almost $600,000 to scientists at Oregon State University, who will evaluate whether some engineered nanomaterials adversely affect human health. Under the first research grant, scientists will review a variety of commonly manufactured nanomaterials to determine their potential interactions with biological processes; if the researchers find nanomaterials that produce adverse human health effects, they will seek to identify the potential cellular and genetic targets of those nanomaterials and group the nanomaterials by composition and effects. The second research grant will focus on how engineered nanomaterials can damage or kill cells, and is expected to lead to the development of occupational and environmental exposure guidelines.

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On June 21, 2007, Environmental Defense (ED) and DuPont, who commenced a partnership on nanotechnology in September 2005, released the final Nano Risk Framework, which establishes “a systematic and disciplined process for identifying, managing, and reducing potential environmental, health, and safety risks of engineered nanomaterials across all stages of a product’s ‘lifecycle.’” The Framework is aimed primarily at organizations, both private and public, that are actively working with nanomaterials and developing associated products and applications. ED and DuPont believe that “adoption of the Frameworkcan promote responsible development of nanotechnology products, facilitate public acceptance, and support the formulation of a practical model for reasonable government policy on nanotechnology safety.”

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The European Commission (EC) will hold its annual Green Week in Brussels, Belgium, from June 12-15, 2007.  On June 14, 2007, an afternoon session will examine the benefits of nanotechnology for the environment and on how nanotechnologies could help to solve major environmental problems, e.g., climate change, energy efficiency, resources use, remediation and pollution prevention, opportunities for developing countries, as well as the potential risks for environment and health.

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On May 17, 2005, the United Kingdom’s (UK) Department for Environment, Food, and Rural Affairs (DEFRA) released a report entitled Environmentally Beneficial Nanotechnologies: Barriers and Opportunities, which provides the results of a study exploring ways in which nanotechnology could reduce the use of non-renewable energy sources and greenhouse gas emissions. The study investigated the opportunities and potential obstacles to adoption of a number of environmentally beneficial nanotechnologies. The resulting report explores the application of nanoscience in the areas of insulation, photovoltaics, electricity storage, engine efficiency, and the hydrogen economy.

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On May 15, 2007, the Natural Resources Defense Council (NRDC) issued a report entitled Nanotechnology’s Invisible Threat: Small Science, Big Consequences, which claims that the U.S. government has failed “to use its authority to protect citizens from the potentially dangerous effects of nano-scale chemistry.”

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On May 10, 2007, EHP-in-Press posted an article entitled “Reviewing the Environmental and Human Health Knowledge Base of Carbon Nanotubes.” The authors reviewed the currently available literature about the human health and environmental risk potential of carbon nanotubes (CNT). The authors also investigated the life cycle of the CNT, as release into different environmental compartments may occur at the production stages as well as the product’s usage and disposal stages, which may indirectly or directly cause human exposure. Because, according to the authors, the published literature revealed many open questions, they also systematically interviewed seven leading scientists worldwide and integrated their contemporary knowledge in the review. The authors interviewed scientists who were key authors or project leaders, having investigated and reported the potential impacts of CNT on human health or environment. Through this combined approach, the authors present an updated and contemporary knowledge base for scientific discussion.

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On April 11, 2007, the European Commission (EC) announced that the report prepared by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) regarding the appropriateness of the risk assessment methodology for assessing the risks of nanomaterials is available for comment. Comments are due May 23, 2007. EC states that the report “provides the Commission with a sound scientific approach on how to modify the Technical Guidance Documents of the EU chemicals legislation in regard to nanomaterials. The report provides proposals for general and specific modifications of risk assessment of human health and the environment, describes a staged strategy for the risk assessment of nanomaterials and identifies areas of further research.”

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The International Council on Nanotechnology (ICON) and Rice University’s Center for Biological and Environmental Nanotechnology (CBEN) announced on March 22, 2007, they have launched a monthly online journal that contains citations and links to articles on the environment and health impacts of nanotechnology. The ICON and CBEN coalition launched the first online database of nanomaterial scientific findings in August 2005, but the new journal -- The Virtual Journal of Nanotechnology Environment, Health & Safety (VJ-Nano EHS) -- “has taken the concept one step further,” the coalition said. The virtual journal organizes the information contained in the existing database into a reader-friendly monthly journal format. New features include a rotating guest editorship and a series of papers on topics of interest taken from the database. Contents of the journal are searchable. In the future, the coalition said, the journal will include a section on the most cited nanotechnology environment, health, and safety papers.

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On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

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In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

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