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June 1, 2011

Upcoming Webinar Will Focus on REACH Data Citation/Compensation Scheme

Bergeson & Campbell, P.C.

Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on June 23, 2011, Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall will participate in a webinar entitled “The Evolving REACH Data Citation/Compensation Scheme: What to Watch for and Why.” The European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). Importantly, REACH also creates a data compensation scheme for entities that must rely upon studies generated by another entity to complete their registration for a particular chemical substance. The webinar will review pertinent REACH registration provisions within the broader construct of the REACH program and focus on REACH’s data compensation and data sharing procedures. The presenters will compare and contrast REACH’s data compensation principles with how similar issues are addressed in the context of U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data compensation arbitrations, practices, and protocols. Registration for the webinar is available online.

The webinar features data compensation experts on both sides of the Atlantic: Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall, of B&C, and Ruxandra Cana, Indiana de Seze, and Michel Michaux, of Field Fisher Waterhouse LLP. Key topics that will be considered include:

  • REACH vs. FIFRA: Overview of key data sharing/data compensation;
  • REACH Substance Information Exchange Forum (SIEF)/Consortia data development, data sharing, data compensation, and antitrust;
  • Data compensation under REACH vs. data compensation under FIFRA (focusing on publicly available studies, compensability period, study quality, historic v. replacement costs, overhead, cost allocation, inflation, risk premium, interest, rights obtained as a result of compensation, and SIEF members and consortium members);
  • Dispute resolution under REACH vs. dispute resolution under FIFRA (focusing on disputes involving the European Chemicals Agency, court proceedings, arbitration, and antitrust concerns); and
  • Data sharing experiences under REACH to date, including key issues, forecast, and next steps.