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France’s nanomaterial declaration

Thursday, May 16th, 2013

I stumbled across a rather brief May 13, 2013 announcement on the ICON (International Council on Nanotechnology) website about a French nanomaterial initiative,

France Extends Deadline for Reporting Nanomaterials (NOECT Blog)

Further investigation landed me on the R-Nano.fr; Declaration of Nanomaterials website,

Welcome to the website for declaring substances with nanoparticle status: “r-nano”. On these pages you can declare the substances with nanoparticle status that you produce, import, distribute, or formulate, as required by Articles L. 523-1 to L. 523-5 of the French Environmental Code.

At the deadline of 30 April 2013, 457 companies have made 1991 declarations. These initial results shows a satisfactory mobilization of stakeholders.

The Ministry of Ecology, Sustainable Development and Energy, considering the diversity of actors covered by the declaration requirement, and at the request of several industries, decided, for the first reporting year, to grant two more months to complete the declarations. Thereby, exceptionally, new declarations can be initiated and submitted until 30 June 2013.

There’s a little more explanation of the site’s raison d’être on the Help/FAQs page,

Q : 1/ Why is there a system for declaring substances with nanoparticle status ?

Because of the advantages offered by their specific properties, substances with nanoparticle status are used in a number of sectors: foodstuffs, aeronautics, cosmetics, alternative energies, pneumatics, health, sport and others. The properties in question are such as to create potential hazards for humans and the environment. As emphasised in the European Commission Communication of 3 October 2012, a substance can present different hazards depending on whether it has bulk status or nanoparticle status.

…

For a better understanding of the issues, it seems necessary to acquire an improved knowledge of the market, including the substances marketed in France, their uses, the sectors in which they are used, the quantities involved, etc.

With the help of this information, it will be possible to estimate exposures more accurately and produce risk assessments for these substances. It is for this purpose that France has decided to introduce mandatory declaration of substances with nanoparticle status, whether in that form, in mixtures or within certain materials.

Q : 2/ How must declarations be made? Is there a special form ?

A web site has been set up on which the various companies concerned can each create an account and submit their declarations. The address of the declaration web site is www.r-nano.fr

Regarding declarations for which applicants wish to make use of the waiver concerning the availability of information to the public provided for activities related to national defence, the declaration will first be made online and then finalised on paper.

…

Q : 3/ At what date does the system come into force ?

The system comes into force on 1 January 2013: the first declarations will concern substances in nanoparticle status produced, imported and/or distributed during 2012.

…

Q : 5/ If a substance with nanoparticle status is indicated on the packaging (case of biocides and cosmetics in 2013), is it still necessary to submit a declaration ?

Yes: the labelling and the declaration system do not have the same purpose.

Q : 6/ Is France the only country in Europe with this kind of declaration system ?

Yes, though Italy, Belgium and Denmark are considering the introduction of similar measures.

Q : 7/ Which players are concerned by the declaration ? (UPDATED)

All national participants in the distribution chain in France covered by the requirement to declare substances with nanoparticle status must complete a declaration if they produce, import into France from another Member State of the European Union or from any other country or distribute any substance, mixture or “article” (article, see Question 18) covered by the definitions laid down in Article R. 523-12 and in quantities exceeding 100 grams/year and per substance.

…

Q : 38/ How will the information supplied be used ?

The information supplied for declarations enables the authorities to estimate the flows of substances with nanoparticle status in France, which will be a “first” for Europe. The knowledge acquired concerning substances and their uses, the production and usage sectors, or the quantities sold, will provide insight into the dissemination of these substances and their actual use.

To help them undertake health risk assessments, authorities will be allowed to request supplementary information from declarers, when available, especially concerning toxicological and ecotoxicological data, as well as data concerning exposure.

…

I have two comments. First, there are over 40 questions in the FAQs but none concern the issue of how this requirement will be enforced. Second, I gather that after abysmal results elsewhere the French concluded that voluntary reporting does not work.

It’s good to see at least [one*] government making an attempt to gather the information openly. The Canadian scheme was managed in a more clandestine fashion. I finally tracked down some information about it in an OECD (Organization for Economic Cooperation and Development) document and featured some of the data from the Canadian nanomaterial reporting scheme (as reported to the OECD)  in my April 12, 2010 posting.

* ETA May 17, 2013: I added the word ‘one’.

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Council of Europe makes some suggestions about regulating nanotechnology

Monday, April 29th, 2013

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),

Recommendation 2017 (2013)1

Provisional version

Nanotechnology: balancing benefits and risks to public health and the environment
Parliamentary Assembly

1. 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.

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US National Institute of Occupational Health and Safety sets recommendations for workplace exposure to carbon nanofibers/nanotubes

Friday, April 26th, 2013

Earlier this week, the US National Institute of Occupational Health and Safety (NIOSH) set recommendations for workplace exposure to carbon nanotubes and carbon nanofibers. According to the Apr. 24, 2013 media advisory from the US Centers for Disease Control and Prevention (NIOSH’s parent agency), the recommendations have been issued in the new Current Intelligence Bulletin (CIB) no. 65. From CIB No. 65,

NIOSH is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. As nanotechnology continues to expand into every industrial sector, workers will be at an increased risk of exposure to new nanomaterials. Today, nanomaterials are found in hundreds of products, ranging from cosmetics, to clothing, to industrial and biomedical applications. These nanoscale-based products are typically called “first generation” products of nanotechnology. Many of these nanoscale-based products are composed of engineered nanoparticles, such as metal oxides, nanotubes, nanowires, quantum dots, and carbon fullerenes (buckyballs), among others. Early scientific studies have indicated that some of these nanoscale particles may pose a greater health risk than the larger bulk form of these materials.

Results from recent animal studies indicate that carbon nanotubes (CNT) and carbon nanofibers (CNF) may pose a respiratory hazard. CNTs and CNFs are tiny, cylindrical, large aspect ratio, manufactured forms of carbon. There is no single type of carbon nanotube or nanofiber; one type can differ from another in shape, size, chemical composition (from residual metal catalysts or functionalization of the CNT and CNF) and other physical and chemical characteristics. Such variations in composition and size have added to the complexity of understanding their hazard potential. Occupational exposure to CNTs and CNFs can occur not only in the process of manufacturing them, but also at the point of incorporating these materials into other products and applications. A number of research studies with rodents have shown adverse lung effects at relatively low-mass doses of CNT and CNF, including pulmonary inflammation and rapidly developing, persistent fibrosis. Although it is not known whether similar adverse health effects occur in humans after exposure to CNT and CNF, the results from animal research studies indicate the need to minimize worker exposure.

This NIOSH CIB, (1) reviews the animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of CNT and CNF, (2) provides a quantitative risk assessment based on animal dose-response data, (3) proposes a recommended exposure limit (REL) of 1 μg/m3 elemental carbon as a respirable mass 8-hour time-weighted average (TWA) concentration, [emphasis mine] and (4) describes strategies for controlling workplace exposures and implementing a medical surveillance program. The NIOSH REL is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of CNTs may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.

The recommended exposure, for those of us who can’t read the technical notation, translates to one microgram per cubic meter per eight-hour workday.  In other words, almost zero. Note that this is a recommendation and not a regulation. H/T Apr. 26, 2013 article by Elizabeth Wiese for USA Today

My Mar. 12, 2013 posting highlights some of the NIOSH research which preceded this recommendation.

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European Union’s NanoCode to be extended to all European science?

Tuesday, February 5th, 2013

The Feb. 5, 2013 Nanowerk Spotlight article is given over to a description of a report on the European Union’s NanoCode Project and recommendations from NanoTrust, a project of the Austrian Academy of Sciences, from spotlight article (Note: Footnotes have been removed),

The [European] Commission recommendation for a code of conduct for responsible nanosciences and nanotechnologies research (code of conduct) dates from 2008. Nevertheless, it continues to be a subject of discussion.

Thus the 2012 final report on the NanoCode research project, which has been monitoring the development and implementation of the nanotechnology code over two years, recommends inter alia that the principles and guidelines of the code be extended to all new technologies and to science as a whole. The initiative for a Commission recommendation on “Responsible research and innovation”, launched by the EU Commission in March 2012 adopts the same approach: The principles and guidelines of the code of conduct should be extended to all technologies and also include production and application.

There are difficulties (implementation issues) associated with implementing the NanoCode, which should be obvious from a glance at the responsibilities/obligations, from the NanoTrust dossier no. 36en, December 2012, The EU code of conduct for nanosciences and nanotechnologies research PDF (4 pp),

“Obligations” on the basis of the code

Researchers

• Research in the public interest

• Consideration of fundamental ethical principles and fundamental rights

• Risk research as an element of all applications for funds

• Responsibility for the consequences of research

Research funding bodies

• Research priorities with respect to socially useful research, risk assessment, metrology and standardisation

• Uniformity of standardisation and metrology

• Accountability in the light of research priorities

• Publication of the cost-benefits assessment of funded projects

Member States

• Collaboration between Member States and the Commission

• Monitoring and control systems

• Dissemination

• Encouragement of research in accordance with the code

• Annual report on application and measures within the framework of the code

EU Commission

• Compliance with the code when granting research funding

• Collaboration with the Member States

• Review of the code every two years

• Dissemination (p. 3)

In addition to implementation, there are issues about authority, compatibility within various legal frameworks, and language, from the spotlight article,

The code is the subject matter of discussions in the legal world. Specifically, the discussion addresses (1) whether the Commission has any jurisdiction to issue such a recommendation; (2) in what manner it could take effect de facto and de jure; (3) whether the principles of the code are sufficiently specific; and (4) whether individual guidelines are compatible with the fundamental rights of the freedom of science.

…

There is also a need to construe the principal responsibility laid down under accountability. In the German version of the code, it is not clear whether this accountability (“Rechenschaftspflicht”) is a legal responsibility or is intended to encourage a “culture of responsibility” (4.1). The term “accountability” in the English version tends not to suggest a legal obligation to render accounts. [emphases mine]

While prospects for implementing the NanoCode are not good, this dossier from NanoTrust provides good insight into the complexities of arriving at agreements of any kind. Documents for the NanoCode project can be found here.

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Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Monday, December 3rd, 2012

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

…

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

…

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada (karen.dodds@ec.gc.ca; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch (hilary.geller@hc-sc.gc.ca; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget (Margaret_A._Malanoski@omb.eop.gov)

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

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Webinar featuring REACH and JRC perspectives on the European Union’s definition of nanomaterials

Friday, November 2nd, 2012

NanoSight is once more hosting a webinar on the European Union’s definition of nanomaterials (the first nanomaterials definitiion webinar was mentioned in my March 6, 2012 posting).  Here’s more about their latest nanomaterials definition webinar,  from NanoSight’s webinar registration page,

Update on the EU Nanomaterials Definition: Impact of Recent EU and JRC [European Commission's Joint Research Centre] Publications

Wednesday, 14th November 2012
Live at 15:00 GMT (16:00 CET, 07:00 PST, 10:00 EST)
Repeated Live at 17:00 GMT (18:00 CET, 09:00 PST, 12:00 EST)

…

Dr Denis Koltsov is an international nanotechnology legislation and control expert. He is Director and Principal Consultant at BREC Solutions offering technology consulting services. He also holds a lectureship in the Department of Engineering at Lancaster University.
Dr Matteo Della Valle is from the REACH Centre, an organization that provides the highest quality advice on the many regulatory, technical and commercial aspects of REACh and other chemical regulations.

…

During the 30 minute interactive presentations, the speakers will

  • Review the JRC methods document and dicuss the key conclusions and the challenges presented
  • Outline the EU’s Second Regulatory Review and forthcoming legislation where it will have most impact with particular emphasis on the REACh [European Community's (Registration, Evaluation, Authorisation and restriction of CHemicals] registration process
  • Report on the USA perspective concerning regulation of nanomaterials. This reporting will include matters tabled as SENN2012 – International Congress on Safety of Engineered Nanoparticles and Nanotechnologies, at the end of this month in Helsinki

As part of this fully interactive presentation you will be able to put your question to both myself and Denis, so please take advantage of this opportunity to clarify any queries you may have.

H/T to Azonano’s Nov. 2, 2012 news item.

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A new standard (in Canada) for occupational exposure to engineered nanomaterials

Wednesday, October 31st, 2012

The Oct. 31, 2012 announcement from the CSA (Canadian Standards Association?) Group (H/T to the Canadian Safety Reporter) is a bit skimpy on details but here goes,

CSA Group, a leading standards development, testing and certification organization officially announces Canada’s first adopted International Organization for Standardization (ISO) standard on nanotechnologies. CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance for the safe use of nanomaterials in the workplace.

“The development of standards is crucial for effective and responsible commercialization of nanotechnologies,” said Brian Haydon, Senior Project Manager, Standards, CSA Group. “CSA Z12885 is the first in a series of standards on nanotechnologies being adopted in Canada, resulting from international and Canadian contributions to the continued activity of ISO/TC 229, the ISO Technical Committee on nanotechnologies.”

CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance to establish and implement a comprehensive managed program to control exposure to nanomaterials in the workplace. This follows recognized approaches to risk management with a focus on information and issues specific to nanotechnologies including hazard identification, risk assessment procedures, training requirements and worker engagement. CSA Z12885 contains revisions to ISO/TR 12885 and additional guidance to reflect Canadian practices and safety considerations.

It’s interesting to note which agencies offered financial support to develop this CSA Z12885 standard,

This standard was announced to industry and research stakeholders at the recent Nano Ontario 2012 Conference in Waterloo, Ontario, Canada. The development of this Standard was made possible, in part, by the financial support of Alberta Innovates Technology Futures – nanoAlberta, Health Canada, MDEIE (Developpement economique, Innovation et Exportation – Gouvernement du Quebec) and the National Research Council Canada – Industrial Research Assistance Program.

I first mentioned this standard in my June 12, 2012 posting about the OECD (Organization for Economic Cooperation and Development) and Canada’s report regarding its nanotechnology initiatives,

4. Information on any Developments Related to Good Practice Documents.

A. The Canadian Standards Association (CSA) Technical Committee on Nanotechnologies – Occupational Health and Safety has completed a draft national standard (CSA Z12885) to provide guidance for workers, entitled “Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings” This document is largely based on the published international ISO Technical Report, ISO/TR 12885:2008 entitled “Health & Safety Practices in Occupational Settings relevant to Nanotechnologies”. The CSA Z12885 standard has completed the public review process and is proceeding to ballot, with completion anticipated in mid-2012.

B. Government, industry, research, user, and consumer interests are participating as designated experts from Canada on international standards development through the Canadian Advisory Committee to International Organization for Standardization/Technical Committee 229 (ISO/TC229) Nanotechnologies, facilitated by CSA Standards. This includes active participation on terminology, nomenclature, measurement, characterization, material specification and health, safety, environmental aspects of nanotechnologies standards under development.

They’ve been working on this standard for at least two years as I first mentioned it in a Sept. 24, 2012 posting about earlier OECD report on Canada’s nanotechnology initiatives.

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How much more nanomaterial safety discussion do we need?

Friday, August 24th, 2012

The report (Impact of Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment) from Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) was issued in Sept. 2011 and the authors are still trying to get people to read it. The Aug. 16, 2012 online issue of Nature features correspondence from the authors citing the report,

Our analysis indicates that formulation of a coherent public policy will depend on scientists closing knowledge gaps in safety research, on gathering more data to connect science and regulation, and on training graduate students in nanotechnology research. Policies will need to be flexible to accommodate fresh discoveries in this rapidly advancing technology.

Getting notice for your work can be hugely difficult in an information-rich environment, so it’s not unusual to see efforts continuing over a year or more after publication.  Meanwhile a question persists, how many reports of this type do we need?

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Buckyball legal suit: all about toys, rare earths, and magnets

Monday, July 30th, 2012

The July 27, 2012 news item by Gary Thomas on Azonano highlights a legal suit involving Maxfield & Obertontoys that happen to be called Buckyballs and Buckycubes. From the news item,

The United States Consumer Product Safety Commission (CPSC) has filed a complaint against New York based Maxfield & Oberton Holdings LLC over their Buckyballs and Buckycube desk toys subsequent to a 3-1 Commission vote approving the filing of complaint.

The complaint seeks an order on the firm to prohibit sale of Buckyballs and Buckycubes, to inform the public about the defect and also refund the consumers in full for purchases made. …

Despite cooperative efforts by CPSC and Maxfield & Oberton to educate buyers that the products are meant for adults, reports of swallowing incidents and injuries kept coming in.

Before I go further, here’s what the toy looks like,

downloaded from Maxfield & Oberton’s http://www.getbuckyballs.com/ home page

The problem is that the small spherical magnets contain rare earths and are being swallowed by children and teenagers resulting in serious injury. I found more details about the situation in the July 25, 2012 news release issued by the CPSC (Note: I have removed some links) ,

In May 2010, CPSC and Maxfield & Oberton announced a cooperative recall of about 175,000 Buckyball high powered magnets sets, because they were labeled “Ages 13+” and did not meet the federal mandatory toy standard, F963-08. The standard requires that such powerful loose as received magnets not be sold for children younger than 14.

The Buckyballs and Buckycubes sets contain up to 216 powerful rare earth magnets.

…

In November 2011, CPSC and Maxfield & Oberton worked cooperatively to inform and educate consumers that Buckyballs were intended for adult use only, and although the risk scenarios differ by age group, the danger when multiple rare earth magnets are ingested is the same. However, even after the safety alert, ingestions and injuries continued to occur.

Here’s more about the number of injuries associated with the Maxfield & Oberton toys and more about how children and why teenagers accidentally swallow the magnets (from the CPSC news release),

Since 2009, CPSC staff has learned of more than two dozen ingestion incidents, with at least one dozen involving Buckyballs. Surgery was required in many of incidents. The Commission staff alleges in its complaint that it has concluded that despite the attempts to warn purchasers, warnings and education are ineffective and cannot prevent injuries and incidents with these rare earth magnets.

CPSC has received reports of toddlers finding loose magnets left within reach and placing them in their mouths. It can be extremely difficult for a parent to tell if any of the tiny magnets are missing from a set. In some of the reported incidents, toddlers have accessed loose magnets left on a refrigerator and other parts of the home.

Use of the product by tweens and teenagers to mimic piercings of the tongue, lip or cheek has resulted in incidents where the product is unintentionally inhaled and swallowed. These ingestion incidents occur when children receive it as a gift or gain access to the product in their homes or from friends.

When two or more magnets are swallowed, they can attract to one another through the stomach and intestinal walls, resulting in serious injuries, such as holes in the stomach and intestines, intestinal blockage, blood poisoning and possibly death. Medical professionals may not diagnose the need for immediate medical intervention in such cases, resulting in worsening of the injuries.

Here’s how the CPSC explains the reason for filing suit (from the CPSC news release),

The Commission staff filed the administrative complaint against Maxfield & Oberton after discussions with the company and its representatives failed to result in a voluntary recall plan that CPSC staff considered to be adequate. This type of legal action against a company is rare, as this is only the second administrative complaint filed by CPSC in the past 11 years.

Michelle Castillo’s July 26, 2012 news item for CBS News provides more background,

Currently marketed to adults, the CPSC reported that more than 2 million Buckyballs have been sold in the U.S., as well as 200,000 Buckycubes. Each container has anywhere from between 10 to 216 small magnets.

…

CPSC spokesperson Alex Filip told CBSNews.com that there were 22 cases of swallowing these magnets from 2009 to October 2011. One of the most high-profile cases was that of a 3-year-old from Portland, Ore., who swallowed 37 magnets. The girl needed surgery after the balls ripped three holes through her intestines.

The American Academy of Pediatrics (AAP)said in a statement that they agreed with the CSPS complaint, adding that the minute size of the magnets made it hard for caregivers to see if one is missing. A survey of North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition members found that there have been more than 60 magnet ingestion cases over the last two years, which necessitated 26 surgeries and involved 23 bowel perforations. It wasn’t stated how many of these cases were related to Buckyball or Buckycube magnets. [emphasis mine]

According to the CPSC information, there were a dozen or more  incidents associated with the Buckyball/Buckycube magnets. I’m unclear as to how many incidents that is per year since 2009 – 2011 could be considered either two years (e.g. July 2009 – July 2011) or three years (Jan. – Dec. of 2009, 2010, and 2011). Regardless,  either four or six incidents per year in the US have been attributed to these Maxfield & Oberton toys (or, seven to eleven incidents based on the total number [22] of accidents involving the ingestion of these kinds of magnets).

Maxfield & Oberton’s response covers a number of points,

“We are deeply disappointed that the CPSC has decided to go after our firm – and magnets in general. Magnets have been around for centuries and are used for all sorts of purposes. Our products are marketed to those 14 and above and out of over half a billion magnets in the market place CPSC has received reports of less than two-dozen cases of misuse. We worked with the Commission in order to do an education video less than 9 months ago, so we are shocked they are taking this action. We find it unfair, unjust and un-American,” added Zucker [Craig Zucker, founder and Chief Executive Officer]. “We will vigorously fight this action taken by President Obama’s hand picked agency.”

Maxfield believes the CPSC is now taking the absurd position that warnings can never work. By doing so, CPSC has called into question the efficacy of all of the warnings the agency relies upon including its recently announced program to warn about the risk of strangulation posed by cords on baby monitors, cords that have been involved in 7 deaths.

What will CPSC do about drowning for which its remedy is warnings?

For balloons involved in several deaths each year, the Commission warns about the risk of suffocation from uninflated or broken balloons and says “Adult supervision required.” But for some reason when it comes to an American company that sells Buckyballs® exclusively to adults, the CPSC takes a different approach and decides that warnings don’t work. The Company believes the CPSC can’t have it both ways.

While this isn’t a nanotechnology story as such, despite what the toys are named, it  does illustrate issues around risk s, hazards, and regulations. What are the benefits? What risks are we prepared to tolerate? What are the hazards and how do we mitigate against them? How much regulation do we need? What are the impacts economically and socially?

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Posted in nanotechnology, pop culture, regulation, risk | 1 Comment »

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