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Posted: March 5, 2009
Industry, NGOs at odds over nanotechnology regulation
(Nanowerk News) A new study has revealed deep divisions on how nanotechnology should be regulated, with environmental lobby groups seeking a moratorium until products are proven to be safe, and industry proposing that specific guidelines be introduced to supplement existing regulations.
The comprehensive new review ("Mapping Study on Regulation and Governance of Nanotechnologies") of existing legislation on nanotechnology, conducted by the FramingNano project, found variation in governance structures across the world and disagreement over whether voluntary codes of conduct will be enough to regulate nanomaterials.
NGOs, including Greenpeace and Friends of the Earth, consider the existing regulatory situation to be inadequate and are urging a strictly precautionary approach. A number of environmental and consumer organisations want nanomaterials to be classified as new substances and subjected to "nano-specific" regulations, according to the report.
Industry representatives are instead seeking the development of specific guidance and standards to support implementation of existing regulations, which are generally seen as adequate.
Experts gathered for a stakeholder dialogue in Brussels last week, where preliminary results of an ongoing FramingNano survey were revealed. More than half the respondents to date have suggested that regulation on the use of nanomaterials in the production of chemicals and food is inadequate.
There is somewhat less concern about cosmetics, medical products and environmental protection, with still fewer respondents voicing fears over medical devices and occupational health.
The FramingNano report elicited responses from a wide range of stakeholders from the chemicals industry to lawyers, NGOs and regulatory authorities.
The European Chemicals Industry Council (CEFIC) said current risk assessment methods in principle provide a suitable framework for the assessment of nanomaterials, but new approaches and methods may need to be developed. CEFIC said the REACH legislation offers a sufficient framework for the evaluation of new and existing nanomaterials. The industry group said it supports a review of existing guidelines to determine if they are adequate for nanomaterials and called for an international approach led by the OECD.
Greenpeace is calling for a public consultation on the issue of nanotechnology development. It has proposed a moratorium on nanotechnology products until a satisfactory regulatory framework can be established and called for the application of the precautionary principle.
The European Trade Union Confederation (ETUC) has published a resolution on "nanotechnologies and nanomaterials," which recognises the potential risks and benefits of nanotechnology while calling for clear and specific actions regarding nanoregulation. The Union wants substantial increases in funding for environmental health and safety issues; the development of standardised terminology for nanomaterials, and full compliance regarding nanomaterials with the "no data, no market" principle laid down in the REACH Directive. The Chemical Agents Directive on health and safety at work should also be amended to ensure safety of worker using nanomaterials, it says.
The German Chemical Industry Association (VCI) said it is committed to responsible production and use of nanomaterials. It pledged to support its member companies and customer companies to address the health, safety and environmental aspects of nanomaterials throughout their entire life cycle.
The Soil Association, a UK charity campaigning for organic food and farming, decided that products, sunscreen, cosmetics and textiles which apply for certification from the Soil Assocation must avoid the use of engineered nanomaterials. Commercial release of nanomaterials should be stopped until there is a sound body of scientific research into all the health impacts, it said.
The International Council on Nanotechnology (ICON) said it is developing frameworks for adequate risk governance approaches at national and international level, and has conducted a survey on the role of governments, non-governmental organizations, industry and research organisations in nanotechnology risk governance.
The American Chemistry Council (ACC) said that in order to deal with nanomaterials, it is necessary to increase funds for research in the area of environmental health and safety. They called for the promotion of international regulatory coordination.
Not-for-profit research body the Environmental Law Institute (ELI) is calling for an effective governance plan for nanotechnologies, which should provide interim measures, focus on data development, inform and involve stakeholders and the public in general and adopt a lifecycle approach, considering multi-statute regulation, for managing risks posed by nanomaterials.
"This approach includes regulatory and voluntary programmes under existing environmental statutes, corporate stewardship, tort liability, state legislation, disclosure, liability insurance, and international measures," ELI states.
The American Bar Association (ABA) underlined the difficulties in implementing legislation, given current knowledge gaps on nanomaterials and limitations faced by risk-assessment bodies.
The Economic and Social Research Council (ESRC), a UK-based funding body, suggests adapting current regulation, developing an integrated approach among different regulations, and improving international standards and guidance. In light of the general lack of information about the risks associated with nanotechnology, the ESRC has underlined the need to examine specific properties of free, engineered nanomaterials and assess their associated risks prior to placing these materials on the market.
The Project on Emerging Nanotechnologies (PEN), a US-based think tank, said most of the existing products using nanotechnology are considered under-regulated. It underlined that current funding for environmental, health and safety research is lacking, and investment in stakeholder engagement in improving and adapting current legislation to nanotechnology is largely inadequate. PEN calls for an in-depth revision of the regulatory system for nanotechnology.
The Alliance of Social and Ecological Consumer Organisations (ASECO), which represents member organisations in 12 European countries, has said it favours international consensus on regulation, particularly regarding standards for nanotechnologies. It says the EU should adapt its regulatory framework and consider establishing a dedicated authority for nanotechnologies. The Alliance favours the precautionary principle in considering marketing applications of consumer products and calls for the urgent adopting of appropriate labeling for nano-related goods.
Environmental lobby group Friends of the Earth (FoE) underlined the current uncertainty on risks posed by some of these nanomaterials and the lack of specific regulation to evaluate, prevent or limit the marketing of products for which there is insufficient evidence of their safety.
The European Environmental Bureau said nanomaterials need to be managed according to fundamental principles of sustainable and responsible development. "No further market introduction should be allowed for products containing manufactured nanomaterials and products are adequately safe to human health and the environment," the EEB told EurActiv.
Sept. 2009: A workshop for nanotechnology experts will be held to discuss the future of nanotechnology regulation.
Nov. 2009: FramingNano will produce a 'road map' for the future governance of nanotechnology.
Feb.-March 2010: National workshops will be held in five member states to disseminate the final FramingNano report.