February 24, 2020

February 24, 2020

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EU NanoSafety Cluster Announces Its Support of the Malta Initiative

On February 18, 2019, the European Union (EU) NanoSafety Cluster (NSC) announced that it is supporting the Malta Initiative by linking various projects with activities developed within the Malta Initiative.  According to NSC’s website, the Malta Initiative began in 2017, when Germany approached the EU Directorate-General (DG) for Research and Innovation to request political and financial support to develop and amend Organization for Economic Cooperation and Development (OECD) Test Guidelines and Guidance Documents to ensure that nano-specific issues for fulfilling regulatory requirements are addressed.  It is a self-organized group without any legally binding status.  In line with existing OECD procedures, any country or organization with expertise interested in working on adapting existing OECD Test Guidelines or developing new OECD Test Guidelines and/or Guidance Documents is welcome to become an active contributor.  The activities of the Malta Initiative are supported through national, international, and EU resources by means of direct funding, in-kind contributions, or providing expertise.  Austria, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, the European Chemicals Agency (ECHA), the European Commission (EC), and OECD’s Business and Industry Advisory Committee (BIAC) currently support the Malta Initiative.

The Malta Initiative Board was formed to facilitate and steer the activities of the Malta Initiative.  Board members were selected to represent EU Member States, EC DGs and agencies, NSC, and industry (notably through BIAC).  Furthermore, according to NSC, members have been selected “to include renowned experts from three relevant fields of expertise, namely:  physical-chemical characterization; environmental and biotic effects; and human health effects.”  The board members also have strong links to various OECD working parties and other groups are familiar with OECD working practices and procedures.  Members (sorted by last name) include:

  • Flemming Cassee (deputy Eugenia Valsami-Jones), NSC (EU);
  • Emeric Frejafon, Institut national de l’environnement industriel et des risques (France);
  • Monique Groenewold (deputy Eric Bleeker), National Institute for Public Health and the Environment (RIVM) (The Netherlands);
  • Elisabeth Heunisch, Federal Institute for Occupational Safety and Health (BAuA) (Germany);
  • Jenny Holmqvist (deputy Celia Tanarro), ECHA (EU);
  • Anke Jesse, Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) (Germany) — chair;
  • Thomas Kuhlbusch, BAuA (Germany);
  • Juan Riego-Sintes (deputy Kirsten Rasmussen), EC (Joint Research Center-Ispra) (EU);
  • Kathrin Schwirn (deputy Doris Völker), German Environment Agency (UBA) (Germany);
  • Jacques-Aurélien Sergent (deputy Karin Wiench), BIAC; and
  • Anne Mette Zenner Boisen, Ministry of Environment and Food of Denmark (Denmark).
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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
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Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
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Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.