OECD Issues Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration. Australia, Canada, Denmark, the European Union, France, Germany, Italy, Netherlands, and the U.S. submitted fourteen responses for legislation covering chemical substances and/or products, including industrial chemicals, therapeutics, foods and drugs, and biocides, as well as occupational health and safety, consumer products, packaging, and labeling. Respondents agreed on using existing regulatory frameworks to regulate nanomaterials, although some jurisdictions, such as France, have developed reporting regimes specific to nanomaterials to gather information on uses and quantities. According to the responses, developing regulatory definitions “still seems to be a fairly challenging issue for regulatory bodies; however, regulatory definitions have been developed and now are being used by some jurisdictions.”  The definitions tend to consider a 1-100 nanometer (nm) size range, unique properties when outside of 1-100 nm, both internal and external structure, and have addressed ways to differentiate between materials that are engineered nanomaterials and traditional chemicals that have nanoscale components by using percentage cut-offs.

Guideline Published for the Danish Inventory of Nanoproducts

In August 2014, the Danish Environmental Protection Agency published the Guideline for the Danish Inventory of Nanoproducts, which is intended to explain how manufacturers and importers of products for consumers should use the new Inventory. The Guideline describes who has a duty to report; which products must be reported; and how to collect information and perform the actual reporting to the Inventory. The Guideline uses questions to determine whether a product must be reported, including the following:

2.         Is your product covered by other regulations?

If you are a manufacturer or importer of only one or more of the following products (mixtures or articles), you are not obliged to report these (see section 3), and you do not have to do anything further:

2.1. Foodstuffs and food contact materials

2.2. Animal feed

2.3. Medicinal products

2.4. Medical devices

2.5. Cosmetics

2.6. Pesticides

2.7. Waste.

For manufacturers and importers that are not exempt, the Guideline includes a flow chart to help determine whether their products are nanoproducts that need to be reported to the Inventory. Manufacturers and importers of products for consumers that must be reported must report by August 30, 2015, for the period beginning June 20, 2014, and ending June 20, 2015.


Bergeson & Campbell, P.C. Contributes Chapter to Biointeractions of Nanomaterials

Bergeson & Campbell, P.C., is pleased to announce that Managing Partner Lynn L. Bergeson and the late Michael F. Cole prepared a chapter in a new book, Biointeractions of Nanomaterials, which covers a wide range of issues associated with the safety of nanomaterials in biological systems. The book, published on July 29, 2014, by CRC Press, addresses issues related to the toxicity and safety of nanomaterials and nanosystems, and covers a range of interactions in biological systems, specifically focusing on the tools and methods used for evaluation, including in vivo and in vitro techniques.

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NNI and NASA Co-Sponsor Technical Interchange Meeting on Carbon Nanotubes

The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled “Realizing the Promise of Carbon Nanotubes -- Challenges, Opportunities and the Pathway to Commercialization” on September 15, 2014. The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and Space Administration (NASA). According to the notice, the objectives of the meeting are to identify, discuss, and report the technical barriers preventing the production of carbon nanotube-based materials with electrical and mechanical properties approaching theoretical values, and to explore ways to overcome these barriers. The notice states that the meeting “will assemble some of the Nation’s leading experts in carbon nanotube research and development, as well as executives and experts from the Federal government, academia, and private sector.” The meeting will be held at NASA Headquarters, in Washington, D.C. Registration opens September 8, 2014, and pre-registration is required. Written comments are due September 10, 2014.

EC Publishes Responses to Public Consultation on Transparency Measures for Nanomaterials on the Market

The European Commission (EC) has posted responses received to its public consultation on transparency measures for nanomaterials on the market. The EC states that it received 202 responses -- 100 respondents submitted the questionnaire for industry stakeholders, and 102 respondents submitted the questionnaire for other stakeholders.  Fourteen respondents requested that their contributions would not be published.  All other contributions are available on the EC’s website.  The EC notes that some contributions are published in anonymous form upon request.  The EC will publish a full summary and analysis of the public consultations “in due course.”

EPA Promulgates Final SNURs, Including Several for Nanomaterials

On September 2, 2014, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances that were the subject of premanufacture notices (PMN). The substances include multi-walled carbon nanotube (generic) (P-08-0392), multi-wall carbon nanotubes (generic) (P-09-257), multi-walled carbon nanofibers (generic) (PMNs P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126), and carbide derived nanocarbon (generic) (PMN P-11-290). Persons who intend to manufacture or process any of these 36 chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The final SNURs take effect November 3, 2014.

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NIOSH Scientist Appointed Convener of International Nanotechnology Working Group

The National Institute for Occupational Safety and Health (NIOSH) announced in its September 5, 2014, eNews that an international committee unanimously selected Dr. Vladimir Murashov, special assistant for nanotechnology to the NIOSH Director, “to lead an international working group on the health, safety, and environmental aspects of nanotechnologies.”  NIOSH states that the working group is part of a larger initiative by the International Organization for Standardization (ISO) to develop standardization in the nanotechnologies field.  According to NIOSH, “[a]s convener, Dr. Murashov will guide the working group as they develop science-based standards to improve worker, consumer, and environmental protections by promoting good practice in the production, use, and disposal of nanomaterials and nanotechnology products.”

Australian Pesticides and Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines. Key topics covered will include the benefits and potential risks; definitions, metrology, properties, and manufacturing; and human health and environmental considerations. APVMA intends to publish a draft nanotechnology report in late September 2014, which will provide a basis for discussion at the symposium.  According to APVMA, it will encourage participants to comment on the report, “thereby contributing to a better regulatory framework for nanomaterials.” Registration for the symposium is now open.

European Industry Associations Call for Balanced Policy on Nanomaterials

Fifteen European industry associations, including the Nanotechnology Industries Association (NIA) and the European Chemical Industry Council (CEFIC), have endorsed a brochure entitled “Europe needs safe and innovative nanotechnologies and nanomaterials.” According to the brochure, the associations “support the European Commission conclusion that the current European regulatory framework adequately covers nanomaterials, is science-based and proportionate.” The brochure highlights seven key points:

  1. Nanotechnologies provide solutions;
  2. Europe needs nanotechnologies to achieve the goals of the EU 2020 strategy;
  3. Safety is paramount;
  4. Openness and transparency are vital;
  5. The comprehensive European regulatory framework in place has the capacity to govern the production and use of nanomaterials;
  6. A common workable definition system for defining nanomaterials is welcome; and
  7. Europe cannot afford to miss out on the opportunities provided by nanotechnologies and the benefits they bring.

Workshop on "Sensor Fabrication, Integration, and Commercialization" Will be Held in September

The National Nanotechnology Coordination Office, on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science and Technology Council, will hold a workshop entitled “Sensor Fabrication, Integration, and Commercialization” on September 11-12, 2014.  According to the August 7, 2014, Federal Register notice announcing the workshop, it will bring together experts from a wide-range of application areas, stages of product development, and manufacturing.  The workshop is intended to identify key challenges faced by sensor developers and determine the critical needs of the community, especially with respect to necessary standards, testing facilities, and advances in manufacturing.  The notice states that the workshop will include case study examples of commercialization success, a small business panel focused on challenges faced in the commercialization of sensors, and breakout sessions to address explicitly the 2013 request for information questions regarding standards, testing, manufacturing, and commercialization.