There was a rather confusing Apr. 27, 2013 news item on Nanotechnology Now about nanotechnology regulation,
As an established vanguard for law governing the right to health, public health and consumer protection throughout Europe, the Council of Europe [CoE] and its human rights court has remained a leading model for jurisprudence throughout the world. Its 47 (forty seven) Member nations embrace 800 million people, including Switzerland. CoE efforts in consumer protection and environmental health exemplify the concept that protection and promotion of the health and welfare of its citizens is considered to be one of the most important functions of the modern state”. CoE legal instruments frequently are the basis of juridical determinations in the Court of Human rights and serve as influential models for the entire world.
The report outlines essential European legal concepts for public discourse concerning nanotechnology safety and the regulation of nanotechnology in commerce: First, the report offers an overview of the legal landscape in nanotechnology regulation confronting everyone: bioethics issues, impact on human and non-human health, environmental impact and the promise of nanomedicine for improving everyone’s quality of life. [emphasis mine] Second, the report helps to chart a path regarding possible treaties or international agreements governing the use and monitoring of nanotechnology.
What has me confused is that the Council of Europe has no real regulatory powers according to its Wikipedia essay (Note: Links have been removed),
The Council of Europe is an international organization promoting co-operation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation. It was founded in 1949, has 47 member states with some 800 million citizens, and is an entirely separate body[1] from the European Union (EU), which has only 27 member states. Unlike the EU, the Council of Europe cannot make binding laws. [emphasis mine] The two do however share certain symbols such as the flag and the anthem.
Additionally, since there have been a number of reports and dialogue/public engagement exercises produced by the European Union, the newest report and a debate which took place on Apr. 26, 2013 in Strasbourg, France at the Council of Europe Parliamentary Assembly seem unnecessary.
Ilise L Feitshans who authored the 16 pp. report (Nanotechnology: balancing benefits and risks to public health and the environment) had this to say in her Apr. 24, 2013 posting on Yahoo about her report,
PRESS ADVISORY: COUNCIL OF EUROPE PARLIAMENTARY ASSEMBLY SEEKS PRECAUTIONARY
PRINCIPLES FOR NANOTECHNOLOGY LAWS April 26 2013
Contact: forecastingnanolaw@… …In 2012, the Council of Europe (CoE) Parliamentary Assembly began the first steps towards nanotechnology regulation with a view to respecting the scientific precautionary principles. It commissioned an expert report, “Nanotechnology: balancing benefits and risks to public health and the environment”, enthusiastically accepted at the CoE meeting of the Committee on Social Affairs, Health and Sustainable Development in November 2012. That same report is slated for public debate before the entire Council of Europe Parliamentary Assembly in Strasbourg France, April 26, 2013.
This is a draft/provisional version of the recommendation accepted by the Council of Europe Parliamentary Assembly (you can find a summary here),
Provisional version
Nanotechnology: balancing benefits and risks to public health and the environment
Parliamentary Assembly1. Nanotechnology is the manipulation of matter on an atomic and molecular scale. Nanomaterials involve structures having dimensions of nanometres (nm), th at is one billionth (or 10-9) of a metre, typically between 1 and 100 nanometres in size. At such dimensions, materials can show significantly different physical, biological and/or chemical properties from materials at bigger dimensions, which opens up a range of new possibilities for technology.
2. Nanotechnology and its myriad applications have the potential for enormous benefits (in particular in the field of “nanomedicine”), but also for serious harm. As with most emerging technologies, many risks, both to public health and to the environment, are as yet poorly understood. However, commercial applications of nanotechnology are already in widespread use. Regulations have struggled to keep up with the pace of
scientific innovation.
3. For years, the Parliamentary Assembly and the Committee of Ministers of
the Council of Europe have been advocating the need for a culture of precaution inco rporating the precautionary principle into scientific and technological processes, with due regard for freedom of research and innovation. In 2005, the Heads of State and Government of the Council of Europe gave undertakings in the Final Declaration of the 3rd Summit of the Council of Europe “to ensure security for our citizens in the full respect of human rights and fundamental freedoms” and to meet, in this context, “the challenges attendant on scientific and technical progress”.
4. The Assembly believes that, in keeping with these undertakings, the Council of Europe, as the only pan-European body with a human rights protection mandate, should set legal
standards on nanotechnology based on scientific knowledge and the precautionary principle, which will protect 800 million Europeans from risk of serious harm, while encouraging nanotechnology’s potential beneficial use.
5. The Assembly thus recommends that the Committee of Ministers work out guidelines on balancing benefits and risks to public health and the environment in the field of nanotechnology which:5.1. respect the precautionary principle while taking into account freedom of research and
encouraging innovation;
5.2. allow for consistent application across borders, across the origins of nanomaterials (synthetic, natural, accidental, manufactured, engineered) and across the functional uses and biological fate of the nanomaterials under regulation;
5.3. seek to harmonise regulatory frameworks, including of risk assessment and risk management methods, protection of researchers and workers in the nanotech industry, consumer and patient protection and education (including labelling requirements taking into account informed consent imperatives), as well as of reporting and registration requirements, in order to lay down a common standard;
5.4. are negotiated in an open and transparent process, involving multiple stakeholders (national governments, international organisations, the Parliamentary Assembly, civil society, experts and scientists) in the framework of a dialogue which transcends the Council of Europe area;
5.5. can be used as a model for regulatory standards worldwide;
5.6. could first take the form of a Committee of Ministers recommendation, but could also be transformed into a binding legal instrument if the majority of member States so wish, for example in the form of an additional protocol to the 1997 Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164, “Oviedo Convention”); [emphasis mine]
5.7. aspire to create an international interdisciplinary centre to be the world’s knowledge base in the field of nanosafety in the near future, without prejudice to the continued support, even in financial terms, to ongoing research projects aimed at determining potential risks of nanomaterials;
5.8. will be able to promote the development of an assessment system
of ethical rules, advertising materials and consumer expectations, regarding research projects and consumer products in thenanotechnology field impacting on human beings and the environment.6. The Assembly recommends that the Council of Europe’s Committee on Bioethics (DH-BIO) be entrusted with a feasibility study on the elaboration of possible standards in this area, based on paragraph 5 of the present recommendation, as a first step in the start of negotiations on the topic with a multiple stakeholder approach. This study should include, in any case, ongoing scientific research at international level to learn about the risks of nanotechnological material. Thus, the scientific community will be actively involved in the drafting of any proposal of standardisation and/or legislation.
1Assembly debate on 26 April 2013 (18th Sitting) (see Doc. 13117, report of the Committee on Social Affairs, Health and Sustainable Development, rapporteur: Mr Sudarenkov). Text adopted by the Assembly on 26 April 2013 (18th Sitting). [emphasis mine]
The whole thing has me somewhat puzzled since the Council of Europe cannot enact ‘binding laws’ and they are somewhat late to the ‘nanotechnology regulation’ party, which has been taking place for years by various constituencies such as the US, Britain, France, Germany, Australia, Canada, the OECD (Organization for Economic Cooperation and Development), ISO (International Standards Organization) and the European Union among others. (Please accept my apologies for not mentioning more regions and linguistic groups but my language skills don’t allow me to scan for as much information as I’d like.)
This particular move by the Council of Europe seems to be of a redundant redundancy (I have borrowed this term from one of my favourite science fiction authors, Lois McMaster Bujold). But perhaps there’s someone out there who can explain why more regulatory standards from the Council of Europe are needed.