OECD Concludes Existing Test Methods and Assessment Approaches Appropriate for Nanomaterials

On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities.” The brochure notes that “[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials.” According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD’s activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation.

International Symposium Slides and Videos of the Plenary Presentations Are Now Available

On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. The presentation slides and plenary videos are now available online.

OECD Publishes New Document in Series on Safety of Manufactured Nanomaterials

The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however.  OECD notes that “this document is a living document,” and was current at the time of WPMN’s ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials.

Background Papers Available from the International Symposium on Assessing the Economic Impact of Nanotechnology

On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. NNI has posted the following background papers:

  • Challenges for Governments in Evaluating Return on Investment from Nanotechnology and its Broader Economic Impact;
  • Finance and Investor Models in Nanotechnology;
  • The Economic Contributions of Nanotechnology to Green and Sustainable Growth; and
  • Models, Tools and Metrics Available to Assess the Economic Impact of Nanotechnology.

OECD and Germany Will Hold Workshop on Safe Management of Nanowaste

On May 9-11, 2012, the Organization for Economic Cooperation and Development (OECD) and Germany’s Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) will hold a workshop entitled “Safe Management of Nanowaste.” According to the draft agenda, the objectives of the workshop are to get a better understanding of the potential risks posed by nanowaste and waste containing nanomaterials; to exchange information about existing initiatives/approaches addressing nanowaste management; and to identify what OECD and member country governments can do to ensure safe management of such materials. After the workshop, the OECD Secretariat will prepare a report on the discussions and conclusions of the workshop, for submission to the next meeting of the Working Party on Resource Productivity and Waste in November 2012.  The report will include proposals for further work and potential role of OECD in this area. Because space is limited, OECD’s Business and Industry Advisory Committee (BIAC) has been invited to nominate up to three participants. Interested persons should contact BIAC by April 11, 2012. Participation will be subject to confirmation, and interested persons should wait for formal confirmation before making travel arrangements.

OECD Provides Snapshot on Current and Planned Activities on the Safety of Manufactured Nanomaterials

On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO).

OECD Publishes Booklet on Nanosafety at the OECD

On February 14, 2011, the Organization for Economic Cooperation and Development (OECD) published a booklet entitled Nanosafety at the OECD: The First Five Years 2006-2010, which covers highlights of activities, priority areas, and major outcomes, as well as outreach in dealing with safety issues arising from manufactured nanomaterials. Regarding next steps, OECD states that its research and development program regarding manufactured nanomaterials is “processing rapidly,” so the program remains flexible to address emerging issues in a “timely and resource efficient way.”  OECD states: “There is still much to learn to fully understand how to work safely with some nanomaterials.  However, if countries continue to work together in the OECD, as they have started to do, this should ensure that the human health and environmental safety aspects are addressed appropriately and efficiently at the same time, as the economic opportunities of the technology advance.”

EPA, EC, and OECD Officials Publish Article in Nature Nanotechnology

Nature Nanotechnology has posted a pre-publication version of an article entitled “Science Policy Considerations for Responsible Nanotechnology Decisions,” which is authored by regulatory officials of the U.S. Environmental Protection Agency (EPA), European Commission (EC), and the Organization for Economic Cooperation and Development (OECD). The authors offer their perspectives on possible approaches to maximizing the environmental benefits of nanotechnology and products that contain nanomaterials while minimizing the negative impacts. For the path forward, the regulators recommend that researchers and risk managers work together to develop approaches to limit exposure and identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. According to the regulators, industry “should contribute significantly to this work because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.” In recognition of the possibility to avoid risk before nanomaterials enter the environment, the regulators “support the application of a life cycle perspective and encourage the development of safer-by-design methods and approaches such as green chemistry for sustainable production of chemicals in ways that reduce environmental impact.”

OECD Posts New and Revised Publications in the Series on the Safety of Manufactured Nanomaterials

On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials: 

  • Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories -- OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.”
  •  
  • List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision -- OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles.

OECD Releases Report on Current Developments and Activities on the Safety of Manufactured Nanomaterials

In a September 22, 2010, report entitled Current Developments/Activities on the Safety of Manufactured Nanomaterials, the Organization for Economic Cooperation and Development (OECD) provides information on current and planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended the seventh meeting of OECD’s Working Party on Manufactured Nanomaterials (WPMN) on July 7-9, 2010, in Paris, France.  The document also includes reports on relevant current activities in other international organizations such as the International Organization for Standardization (ISO) and the World Health Organization (WHO).

OECD Publishes Guidance Manual And Preliminary Guidance Notes

On June 8, 2010, the Organization for Economic Cooperation and Development (OECD) announced the publication of two materials for use in the OECD Sponsorship Programme. The first is a revision of the Guidance Manual for the Testing of Manufactured Nanomaterials. According to OECD, the revised Guidance “is intended to support the testing undertaken in the context of OECD’S Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate, and consistent.” OECD states that the second document, entitled Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, was published to assist the sponsors of the OECD Sponsorship Program, as well as to help others involved in the safety testing of manufactured nanomaterials.

ECHA Publishes Technical Manual for Including Nanoforms in an IUCLID Dossier

On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.” The Manual introduces a book-keeping principle, where each form gets a specific label that enables it to be tracked throughout the dossier. Instructions are given on how to create labels for form-specific reference substances, composition blocks, endpoint study records, and analytical data. In particular, the Manual “gives instructions that will enable registrants to consistently create and label Endpoint study records such that it is clear which composition or form was used as the test substance for that study.”

Continue Reading...

ECHA Revising REACH Guidance Documents to Include Nanomaterials

During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm, ECHA is following “international developments,” particularly work by the Organization for Economic Cooperation and Development (OECD) concerning nanomaterial safety and testing. Malm stated: “As results become available, we are trying to introduce them into our guidance documents for steering industry on how to implement REACH in practice in their registration dossiers and other obligations.”

OECD Posts Reports Concerning Nanomaterials

The Organization for Economic Cooperation and Development (OECD) posted on May 5, 2010, two reports concerning nanomaterials:

  • Report of the Workshop on Risk Assessment of Manufactured Nanomaterials in a Regulatory Context: This is the Report of the September 2009 Workshop on Risk Assessment of Manufactured Nanomaterials in Regulatory Context, which was co-hosted by the Business and Industry Advisory Committee (BIAC) and the Society for Risk Analysis (SRA). According to OECD, the Workshop provided an opportunity to discuss critical issues specific for risk assessment of nanomaterials in a regulatory context, and to identify approaches for risk assessment based on the current state of knowledge.

 

  • Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials: According to OECD, this Report presents the information obtained from the Questionnaire on Regulatory Regimes on Manufactured Nanomaterials. OECD analyzed 24 legislations from nine jurisdictions. The Report summarizes objectives and activities covered by each legislation, as well as information on registration/notification, assessment, and management of substances that are either premarket or already in commerce. It also provides a number of legislative features identified in the legislations for consideration when amending or drafting legislation for regulatory oversight of nanomaterials and their products.

PEN Holds Meeting on Transatlantic Regulatory Cooperation

On September 23, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Technologies (PEN) hosted a meeting on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies.” The program is part of a collaborative research project involving experts from the London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and PEN. The project is funded by a grant from the European Commission to support pilot projects on “Transatlantic methods for handling global challenges.” The purpose of yesterday’s meeting was to discuss recommendations from the research effort that are part of a report released on September 10, 2009. The meeting was also intended to generate and examine new ideas to enable greater transatlantic convergence on nanotechnology oversight today and in the future.

Continue Reading...

ETC Group Issues Report on Nanogeopolitics

Earlier this month, in advance of the Organization for Economic Cooperation and Development’s (OECD) July 15-17, 2009, Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth, the Action Group on Erosion, Technology, and Concentration (ETC Group) issued a draft report entitled Nanogeopolitics 2009:  The Second Survey.  ETC Group recommends that policies concerning nanotechnologies be developed within the United Nations (UN) system, “where all nations can have a say about the technology and where the so-called nano-nations will come clean with everybody else about what they are doing to the economy and the environment.” The report is a follow up to the ETC Group’s 2005 survey of “the nanogeopolitical landscape.”  In the report, ETC Group reviews:  (1) the extent to which the “markets and players” have shifted position since 2005, especially in terms of research and funding; (2) the effectiveness of various governance and regulation; and (3) recommended action to regulate better and develop responsibly nanotechnology.

UN Committee Will Discuss Ongoing Work on the Safety of Nanomaterials

During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

  • Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
  • Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
  • How can this be done? Should new endpoints be determined?
  • To which extent information about nanomaterials need be provided?
  • What kind of information is needed?
  • What kind of communication tool is needed for this purpose?
  • What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

 

NIOSH Posts Update Regarding Nanotechnology Research

In an October 2, 2008, Update entitled “NIOSH Nanotechnology Research News Notes:  New Papers on PPE, Toxicity; New Partnerships, Award,” the National Institute for Occupational Safety and Health (NIOSH) describes two new peer-reviewed papers, two new international partnerships, and a professional award.

Continue Reading...

European Commission Begins Public Dialogue on Nanotechnologies

On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies -- tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with stakeholders and member states that it intends “to increase knowledge and awareness about the potential of nanotechnologies and to continue to ensure an adequate protection of nature, environment and health.” Under “Next Steps,” the EC states:

Knowledge about the characterisation of nanomaterials, hazard and exposure needs to be improved. The Commission is therefore backing targeted actions in a number of areas and at different levels, particularly in the field of research and development under the Research Framework Programmes FP6 and FP7 and the Commission’s Joint Research Centre.) Such activities are coordinated and discussed with stakeholders and in the framework of the [Organization for Economic Cooperation and Development (OECD)] and the International Standardisation Organisation (ISO) and through international cooperation.

The Commission will also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.

Danish Report Finds Nanotechnology Covered by Existing Legislation

According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards. Continue Reading...

Lloyd's Releases Report Examining Risks And Opportunities

On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.” Continue Reading...

NIOSH Summarizes Recent International Activities

On December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research:

  • On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to establish a NIOSH-led project to: (1) exchange information on measuring and controlling exposures to nanomaterials; and (2) develop suggestions for further steps by the Working Party.
  • At a December 4-7, 2007, meeting, a project group of the International Organization for Standardization (ISO) Technical Committee 229 voted to approve a draft report of safety and health practices in occupational settings relevant to nanotechnology. The draft report was based on NIOSH’s interim document entitled Approaches to Safe Nanotechnology, and was developed with NIOSH leadership and participation on the project group. 
  • On December 2, 2007, NIOSH participated in a meeting of the World Health Organization’s (WHO) Global Network of Collaborating Centres in Occupational Health, focusing on nanotechnology. The objective of the meeting was to determine how the WHO collaboration can develop and support research and cooperation in preventing exposure to potentially hazardous engineered nanoparticles. NIOSH is collaborating on five communication and networking projects with various WHO centers.

DEFRA Publishes Research Report On Manufactured Nanomaterials

On December 19, 2007, the Department for Environment, Food and Rural Affairs (DEFRA) published a report entitled Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report, which follows up on DEFRA’s 2005 report and 2006 progress report. The report reviews the status of research pertaining to the environmental, health, and safety (EHS) issues relating to engineered nanoparticles, and places the United Kingdom’s (UK) research program in an international context. DEFRA is collaborating with international partners, particularly the Organization for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO), to share data and experiences. In this way, according to the report, DEFRA will be able to maximize the effectiveness and speed with which potential risks may be identified and managed.

OECD Announces Launch of Nanomaterials Testing Program

On December 4, 2007, the Organization for Economic Cooperation and Development (OECD) posted a notice entitled “Testing a Representative Set of Nanomaterials -- The Launch of a Sponsorship Programme.” OECD states that its Working Party on Manufactured Nanomaterials has launched a sponsorship program in which countries will share the testing of specific nanomaterials. According to OECD, valuable information on the safety of manufactured nanomaterials can be derived by testing a representative set for human health and environmental safety. In launching the sponsorship program, the Working Party agreed to a priority list of manufactured nanomaterials for testing, based on materials which are in or close to commerce, as well as a list of endpoints for which they should be tested. OECD intends to make regular updates on this program.

Swedish Chemicals Agency Releases Recommendations Regarding Nanotechnology

The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology -- Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover nanomaterials. Continue Reading...

U.S. - European Union Integration on Nanotechnology

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.

Continue Reading...

Lynn L. Bergeson Presents What's New in Nanotechnology

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.