Behind the buzz and beyond the hype:
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Posted: Aug 20th, 2007
OECD tackles nanotechnology risk issues on a global basis
(Nanowerk Spotlight) The Organization for Economic Co-operation and Development (OECD) is an intergovernmental organization in which representatives of 30 industrialized countries in North America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonize policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD's work is carried out by more than 200 specialized committees and working groups composed of
member country delegates. The OECD's Environment, Health and Safety Division has taken up the safety of nanomaterials as one of their priority issues. After several preliminary meetings in 2005 and 2006, the OECD's Chemical Committee set up a Working Party to address the health and environmental safety implications of manufactured nanomaterials (the WPMN). After a meeting in Berlin, Germany earlier this year, the WPMN has just released a document that compiles information provided by member countries and other delegations on current developments on the safety of manufactured nanomaterials in their countries or organizations and also on current activities related to nanotechnologies and nanomaterials in other International Organizations such as the International Organization for Standardization (ISO). The report makes clear that there are numerous projects and initiatives going on with regard to nanotechnology safety research. It would be nice at some point to see all these research results come together in one coherent and conclusive set of results as to where and what the risks are and how they will be controlled and managed.
Here are some of the key activities and initiatives undertaken by the major industrial countries:
The Australian Government is currently developing its response to the paper "Options for a National Nanotechnology Strategy" (pdf download; 804 KB) delivered by its National Nanotechnology Strategy Taskforce to the Australian Industry Minister on 30 June 2006. The report recommends an integrated package of nine elements: (1) establish a dedicated federal office responsible for developing and coordinating the implementation of a national nanotechnology strategy; (2) health, safety and environmental issues (HSE); (3) community awareness and public engagement; (4) metrology and standards; (5) coordination of whole of government activities across Federal and State jurisdictions; (6) international cooperation; (7) industry infrastructure; (8) industry development; and the (9) commercialization and application of nanotechnology research.
Back in 2004, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), the regulator of industrial chemicals, issued a voluntary call (pdf download; 396 KB) for information to importers and manufacturers nanomaterials.
A nanotechnology workshop for the Health Portfolio was held in March 2007. Participants from Health Canada, the Public Health Agency of Canada, and the Canadian Institutes of Health Research met with invited experts to discuss the basis for a Health Portfolio Strategy on Nanotechnology. Participants identified concrete needs and objectives for actions under the headings of: Safety of health products and foods; Consumer products safety including cosmetics and substances under the Canadian Environmental Protection Act; and occupational health and safety. A Health Portfolio Nanotechnology White Paper will be produced based on a previously developed Health Portfolio Issue Paper and the findings of the workshop.
A regulatory regime for nanomaterials, targeting mainly industrial substances, is being considered by the New Substances Program of Environment Canada and Health Canada.
There is a limited understanding of the current Canadian market for nanotechnology. A formal use pattern survey and product inventory has not been conducted for Canada; however, Industry Canada has undertaken some preliminary investigations.
The Commission is performing a regulatory inventory, covering EU regulatory frameworks that are applicable to nanomaterials (chemicals, worker protection, environmental legislation, product specific legislation etc.). The purpose of this inventory is to "examine and, where appropriate, propose adaptations of EU regulations in relevant sectors."
The EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted an opinion on "The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies" in March 2006 after the public consultation of the first version adopted in September 2005. In essence, the SCENIHR scientific opinion states that "given ... uncertainties [concerning respectively hazard and exposure], the current risk assessment procedures require modification for nanoparticles."
The Commission has dedicated up to now around €25 million to nanotechnology research projects particularly focused on safety aspects (additional funds have been made available within nanotechnology projects with targets not specifically related to safety) and intends to continue rising the funds available for risk-related research activities. Currently there are 6 calls calls directly related to safety of nanomaterials in the FP7 framework programme.
There have been no regulatory developments to date. However, recommendations have been issued by both the Prevention and Precaution Committee (CPP) and the French Agency for
Labour and Environmental Health Safety (AFSSET) regarding the need to take precautionary measures in the workplace and the general environment, to list the nanomaterials produced or imported and to ensure that they are included in the REACH Regulation. The results of the additional AFSSET study covering, in particular, the assessment of professional risks, are expected by year-end 2007.
French partners to the integrated European NANOSAFE2 project, which is co-ordinated in France by the Atomic Energy Commission (CEA), are: the National Institute for Industrial Environment and Risks (INERIS), the National Institute for Health and Medical Research (INSERM), the ECRIN Association and the industrial firm Arkema. It should be added that the project includes a segment on societal and regulatory aspects.
The above organizations, but also the National Centre for Scientific Research (CNRS), the National Research and Safety Institute (INRS) and university research teams (from Paris, Toulouse, etc.), are working separately or jointly to develop research programmes to identify and develop the metrology needed to characterize human exposure and enhance knowledge of the toxicity of nanoparticles and nanotubes.
The Federal Environment Agency (Umweltbundesamt - UBA) has completed a study on regulatory gaps and options (pdf download, 1.02 MB, in German). This study examined European (REACH) and German chemical and environmental legislation. The final report with conclusions and recommendations has been published on the UBA web page.
The Federal Institute for Occupational Safety and Health (BAuA) developed in collaboration with the Chemical Industry Association (VCI) a questionnaire to elucidate exposure of nanomaterials and risk management at workplaces of the chemical industry and research institutions. The feedback from industrial and research companies was evaluated, summarized and will be published soon.
The joint German research strategy, developed by the BAuA (Federal Institute of Occupational Safety and Health) together with BfR (Federal Institute for Risk Assessment) and UBA (Federal Environment Agency) considering health issues of workers and consumers and the environment issues had been discussed with stakeholders from industry, science, policy, and NGO's.
The Consumer Conference on Nanotechnology was launched as a pilot project by the Federal Institute for Risk Assessment (BfR) and was jointly staged with the Independent Institute for Environmental Concerns (UfU) and the Institute for Ecological Economic Research (IÖW). It draws on the model of the Danish consensus conference and is being tested by BfR as one possible tool of extended risk communication. The staging of a consumer conference puts BfR's statutory remit on risk communication into practice by directly involving groups of consumers in the discussions about the risks and benefits prior to the introduction of a broadly based consumer application of this technology. This is the first time that a public agency in Germany has used this tool.
In the existing regulatory system, the Chemical Substance Control Law obliges manufacturers to notify the government about nanomaterials if they are new chemicals subject to the law, and some notifications concerning fullerene derivatives have been submitted under the small quantities exemption of the new chemical notification.
The promotion and the social acceptance of nanotechnology has been considered as an important issue, and the R&D for the social acceptance of nanotechnology has been focused as a strategic Science and Technology Priorities in the 3rd Science and Technology Basic Plan in Japan. Also, The Cabinet Office has decided to establish a committee that coordinates research and development policy on nanotechnology. One of its targets is to establish the information infrastructure to accelerate innovation, by facilitating research and development of nanotechnology and research for public acceptance of nanotechnology in a focused and strategic manner.
The Ministry of Economy, Trade and Industry (METI) has launched a five-year project named "Evaluation of the Potential Risks of Manufactured Nanomaterials based on Toxicity Tests with Precise Characterization." The project focuses on toxicity test protocols (mainly an inhalation test) and a risk assessment methodology of manufactured nanomaterials.
The UK Government's Voluntary Reporting Scheme (VRS) for engineered nanoscale materials was
introduced on 22 September 2006. The VRS is run by Defra and will run to September 2008. To date 6 submissions have been received under the VRS. The VRS is targeted at any company or organization involved in manufacturing, using, importing or managing wastes consisting of engineered nanoscale materials. Information requested includes any data on: physico-chemical, toxicology, ecotoxicology and risk management practices. A data reporting form has been provided.
The UK Nanotechnology Research Coordination Group (NRCG) was established in 2005 to develop and oversee the implementation of a cross-Government research programme on the potential human health and environmental risks posed by free engineered nanoscale materials. The NRCG works to a programme of nineteen research objectives which aim to characterize the potential risks posed by free engineered nanoscale materials. The NRCG published its first progress report (pdf download; 666 KB) on 19 October 2006.
The Environmental Hazard and Risk Assessment Task Force commissioned the Environmental Nanoscience Initiative during 2006 and closed a call for research proposals into the environmental effects of manufactured nanomaterials in November. Funding was allocated in April 2007 to 11 successful
grantees, covering, environmental fate, behavior and ecotoxicology in soil, aquatic and marine environments.
The Department for Environment, Food and Rural Affairs (Defra) is currently funding three underpinning research contracts on nanomaterials. One is looking into the development of reference nanomaterials, the second is studying current and future environmental exposure to nanomaterials and the third is reviewing the potential of existing methods for evaluating environmental hazards of chemicals for use with materials at the nanoscale. These are due to report in summer 2007.
The Nanoscale Science, Engineering, and Technology (NSET) Subcommittee's Nanotechnology Environmental and Health Implications (NEHI) Working Group provides for exchange of information among agencies that support nanotechnology research and those responsible for regulation of nanotechnology-related products. The Working Group also seeks to facilitate research and other activities that support responsible development of nanotechnology. NEHI has released a document entitled "Environmental, Health, and Safety Research Needs of Engineered Nanoscale Materials" (pdf download; 1.1 MB) that identifies EHS research needed to enable risk assessment and risk management of nanoscale materials.
The NSET Subcommittee member agencies are active participants in national and international standards development activities, including those of ISO Technical Committee on Nanotechnologies (TC 229), American National Standards Institute- Nanotechnology Standards Panel and ASTM International's Nanotechnology Committee (E56).
The Food and Drug Administration (FDA) has initiated an internal Task Force on Nanotechnology that has examined regulatory approaches to manufactured nanomaterials. The Task Force released its report ("Nanotechnology Task Force Report"; pdf download 259 KB) on July 26, 2007, recommending the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.
The Environmental Protection Agency (EPA) is developing guidance under the Toxic Substances Control Act (TSCA) in order for manufacturers of nanoscale materials to make the distinction between new and existing chemicals on the TSCA Inventory.
EPA has received and reviewed a number of new chemical notices for potential nanoscale materials under TSCA. EPA has permitted manufacture of these nanoscale materials under limited conditions.
EPA will hold a public meeting, Thurs., Sept. 6 and Fri., Sept. 7, 2007 in Arlington, Va., in line with its continuing effort to better understand the potential risks and benefits of nanotechnology. The meeting's goal is to help develop EPA's Nanoscale Materials Stewardship Program under the Toxic Substances Control Act (TSCA). It's one of several actions EPA has been taking to gather information to better understand potential risks and benefits of nanotechnology.
In February, the Science Policy Council of EPA had already issued the final version of its Nanotechnology White Paper (pdf download, 2.6 MB). The purpose of the White Paper is to inform EPA management of the science issues and needs associated with nanotechnology, to support related EPA program office needs, and to communicate these nanotechnology science issues to stakeholders and the public.
The U.S. National Institutes of Health (NIH), U.S. Department of Health and Human Services, established a "Health Implications Working Group" to consider unintentional exposures to manufactured nanomaterials and intentional exposures to nanodiagnostics and therapeutics, as part of a larger Tran-NIH Nanotechnology Task Force.
Also under the aegis of NIH/NIEHS, and in collaboration with the FDA and NIOSH, the National Toxicology Program's Nanotechnology Safety Initiative is undertaking toxicological evaluations of specific engineered nanoscale materials. The U.S. Consumer Product Safety Commission (CPSC), EPA and the U.S. Occupational Safety and Health Administration (OSHA) are also active participants in this initiative.
Research programs directed at environmental, health, and safety (EHS) impacts of nanotechnology development, and risk assessment of such impacts are a growing component of the U.S. National Nanotechnology Initiative. R&D leading to a detailed understanding of the health and safety impacts of nanotechnology for researchers, workers, consumers, and the public is a strategic priority within the NNI's Societal Dimensions Program Component Area. The actual spend for EHS R&D in 2006 was $37.7 million; 2007 spend is estimated at $45.8 million; and 2008 proposed spend is $58.6 million.