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

The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

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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 April 24, 2007, the Kojo Nnamdi Show, a news magazine program on National Public Radio (NPR), aired a program entitled “New Approaches to Nanotechnology.” The program featured: David Rejeski, Director, Project on Emerging Nanotechnologies (PEN), Woodrow Wilson International Center for Scholars/Pew Charitable Trusts; Rick Weiss, Science and Medicine Reporter, The Washington Post; Jeffrey Schloss, Co-Chair, Trans-National Institutes of Health (NIH) Nano Taskforce, NIH; and Nora Savage, Environmental Engineer, Office of Research and Development (ORD), U.S. Environmental Protection Agency (EPA).

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The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.

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On May 30, 2007, the Canadian Institute for Environmental Law and Policy (CIELAP) released a document entitled Discussion Paper on a Policy Framework for Nanotechnology, which builds on policy issues discussed at a March 16, 2007, workshop. CIELAP states that it supports a goal statement and context for nanotechnology policy that is centered on an explicit recognition and endorsement of sustainable development.  According to CIELAP, the policy challenges for nanotechnology are enormous, and currently are dominated by a lack of scientific information and basic policy tools, including definitions and metrology; a legal and regulatory framework; and structures and resources for public engagement.  CIELAP notes that, despite these gaps, however, many parallels with other issues and institutional arrangements exist, and could be adapted for nanotechnology.  Due to nanotechnology’s extraordinarily rapid commercialization and development, speed and a strong sense of urgency are needed by government for a responsible Canadian approach to the creation of policy for this area.

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On May 23, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled EPA and Nanotechnology: Oversight for the 21st Century, which identifies actions that should be taken to establish an oversight system. The report focuses in particular on the U.S. Environmental Protection Agency (EPA), which it describes as “a key agency in any oversight effort because of its numerous regulatory authorities and its mission to protect the environment and human health.” According to the report, a review of existing EPA authorities reveals a number of weaknesses. In particular, the report states that the Toxic Substances Control Act (TSCA), “which is the only law potentially capable of providing general oversight for nanotechnology, is extremely deficient in many respects and needs to be amended.” Moving beyond TSCA, the report states further that “virtually every authority that EPA has at its disposal has weaknesses in terms of nanotechnology oversight.” The report discusses tools that will need to be combined in an oversight system, including information tools, voluntary efforts, economic tools, and liability. The report also discusses the role of state and local governments, and public participation, and outlines nine different examples of the ways the tools could be used. The report concludes with an action agenda containing more than 25 actions necessary to improve the oversight of nanotechnologies.

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According to a recent report entitled Nanomaterials in Consumer Products, the extent to which a variety of European regulations would manage potential risks of nanomaterials in consumer products cannot be assessed. The report was prepared for the European Parliament’s Committee on the Environment, Public Health, and Food Safety. According to the report, which is not publicly available, “[u]ntil there are data on which to determine the nature of any risks posed by nanomaterials, it is not possible to assess the full extent to which the implementation of current regulations addresses any potential risks.”  The report makes recommendations about policies that could be used if it is determined that existing European laws are inadequate.

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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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It has been suggested by some that REACH’s application to nanoparticles and nanomaterials is unclear.  While it is true that REACH does not specifically mention nanoparticles or nanoscale materials anywhere in its 800+ pages of text, we note that in December 2006, shortly after the regulation’s adoption by the European Parliament, the European Commission posted on its website a question-and-answer document that includes the following two exchanges:

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At the 2007 U.S.-European Union (EU) Summit in Washington, D.C. late last month, President Bush and European Union (EU) leaders signed an economic integration agreement, the Framework for Advancing Transatlantic Economic Integration Between the United States of America and the European Union.

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Two researchers at the University of Missouri -- Columbia’s College of Engineering have received an $84,000 grant from the National Science Foundation (NSF) to study the potential effects of silver nanoparticles on wastewater treatment systems. According to a university press release, Baolin Deng, an associate professor of civil and environmental engineering, and Zhiqiang Hu, an assistant professor of civil and environmental engineering, “will determine how silver nanoparticles interact with bacteria that are used for wastewater treatment.” Already present in a wide range of consumer products, silver nanoparticles enter the wastewater stream when people who have used silver nanoparticle-enhanced products (e.g., cosmetics, bandages) wash themselves. The study is expected to be completed by June 2008.

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On May 11, 2007, the United Kingdom (UK) Health & Safety Executive (HSE) published its first bulletin on nanotechnology research. The bulletin is intended to provide an overview of published studies that have examined the exposure and potential health effects of nanomaterials, particularly in the occupational setting. According to HSE, inevitably there will be some overlap between studies of exposure of other groups (i.e. consumers).  HSE screened the literature search results to ensure that the studies listed are relevant to HSE and its responsibility to manage health and safety in the workplace. The first bulletin reviews literature published in 2000-2006. According to HSE, subsequent bulletins will summarize publications from the previous four-month period. The bulletins will summarize the range of studies that have been published in two areas of interest: measurement, characterization, and control of exposure to nanoparticles; and potential for toxic effects of nanoparticles in humans.

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On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.”  The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.

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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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Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA).

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On May 4, 2007, the European Commission (EC) released a document entitled Strategy for Communication Outreach in Nanotechnology, which is a working paper from the EC’s February 6, 2007, workshop. The paper includes recommendations for future European funding on appropriate communication and innovative approaches to engage the European civil society in a dialogue on nanotechnology, including:  surveying the public; developing new models and tools for communication; developing the role of choice-making process; and ensuring access to reliable information. Comments on the paper are due June 30, 2007.

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The Toxics Management Division (TMD) in the City of Berkeley’s Planning and Development Department has issued guidance on the nanoparticle municipal ordinance that the Berkeley City Council adopted on December 12, 2006. Under the ordinance, facilities that manufacture or use “manufactured nanoparticles” must submit to the TMD “a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.” The term “manufactured nanoparticles” is defined to mean particles “with one axis less than 100 nanometers in length.” The TMD guidance makes clear that facility reports covering the period June 1, 2007 -- June 2, 2008, are due by June 1, 2007, and must include, among other things, toxicological and ecological information about the nanoscale material and information about the potential exposure pathways and likelihood of exposure via those pathways.

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An undergraduate fashion design student, a fiber science professor, and a postdoctoral researcher at Cornell University in New York have teamed up to design what may very well be the world’s first garment “that can prevent colds and flu.” According to a May 1, 2007, news release, the three collaborators produced a dress from cotton fabrics that had been coated with silver nanoparticles. Silver, of course, is a well-known antimicrobial. Cotton fibers were positively charged through the use of ammonium- and epoxy-based reactions, while silver nanoparticles were synthesized in citric acid to hinder nanoparticle agglomeration. “Dipping the positively charged cotton into the negatively charged silver nanoparticle solution resulted in the particles clinging to the cotton fibers.” Assistant Professor Juan Hinestroza points out, though, that a single square yard of the nano-treated cotton would cost about $10,000.

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On April 30, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its latest Semiannual Regulatory Agenda, which serves to update the public on regulations and major policies currently under development by EPA.  One of the entries in the Toxic Substances Control Act (TSCA ) portion of the agenda is entitled "Nanoscale Materials Under TSCA" and addresses the forthcoming Nanoscale Materials Stewardship Program (NMSP), the design of which EPA publicly announced in October 2006.  The agenda entry estimates that drafts of various documents -- "a document that describes the specific elements of the voluntary [NMSP]," "an updated document that describes the approach to nanoscale materials under TSCA and a paper that describes determining the inventory status of nanoscale materials" -- will be made available sometime this month.  While we recognize that the Regulatory Agenda is often quite inaccurate in terms of forecasting, we did not want this brief update to go overlooked.  The NMSP documents are currently undergoing inter-agency review.

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On April 16, 2007, the U.S. Environmental Protection Agency (EPA) announced that, due to a technical problem, it is unable to verify receipt of contact information from anyone who subscribed to the e-mail notification list on the Office of Pollution Prevention and Toxics (OPPT) Nanotechnology web page from October 18 to November 1, 2006, and again from January 18 to January 23, 2007.  According to EPA, it has corrected the problem and is now compiling a list of stakeholders to contact as the Nanoscale Materials Stewardship Program moves forward.  EPA requests that anyone who subscribed to the e-mail notification during these periods do so again.

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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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On April 3, 2007, the United Kingdom’s (UK) Department of Environment, Food, and Rural Affairs (DEFRA) released its second quarterly update on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the update, DEFRA has received a total of six submissions since VRS’s launch in September 2006, four of which were from industry and two from academia. DEFRA has liaised with groups representing the UK nanotechnologies industry and has made direct contact with companies involved in the sector. From these contacts, DEFRA believes that “a number of VRS submissions are being prepared and will be delivered” in the near future. During discussions with industry, DEFRA sought feedback on VRS, and industry raised the following issues: uncertainty regarding the scope of VRS; resources; and confidentiality issues. The next update will be published in June 2007.

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In mid-March 2007, Representative Jim Saxton (R-NJ), the ranking minority member of the Joint Economic Committee (JEC), released a new Congressional study on nanotechnology. On balance an extremely positive report, the JEC Study “discusses the range of sciences currently covered by nanotechnology,” describes “what nanotechnology is and how it relates to previous scientific advances,” as well as “the most likely future development of different technologies in a variety of fields,” and includes a review of the federal government’s current nanotechnology policy. Importantly also, the report urges three changes pertinent to the use of nanotechnology in products: product labeling; disclosure to FDA of safety testing and publication of any adverse results; and enhanced public education in the area of nanotechnology.

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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 January 22, 2007, ISO published a report entitled Workplace Atmospheres -- Ultrafine, Nanoparticle and Nano-Structured Aerosols -- Inhalation Exposure Characterization and Assessment, which includes information on the potential health effects of nanoaerosols, sources of occupational nanoaerosols, exposure assessment strategies, particle ensemble characterization methods, size-resolved characterization, online chemical analysis, single particle analysis, and electron microscopy sample collection and preparation. The report states that its aim is “to provide generally accepted definitions and terms, as well as guidelines on measuring occupational nanoaerosol exposure against a range of metrics.” ISO intends the report to address an immediate need and establish an essential step for developing future exposure assessment standards for nanoaerosols.

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At the 2007 GlobalChem Conference in Baltimore, Maryland, Lynn L. Bergeson presented slides on “Nanotechnology:  What’s New.”  Bergeson & Campbell, P.C. co-sponsored this important conference.

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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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In February 2007, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled Progress Toward Safe Nanotechnology in the Workplace, which summarizes the progress made by the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006.  According to NIOSH, by redirecting existing resources, NTRC developed a research program that has made progress towards hazard identification and characterization, exposure assessment, risk assessment, and risk management.

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