The European Union’s 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.
This webinar will review pertinent REACH registration provisions within the broader construct of the REACH program and focus 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.
This webinar features data compensation experts on both sides of the Atlantic: Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall, of Bergeson & Campbell PC and Ruxandra Cana, Indiana de Seze, and Michel Michaux, of Field Fisher Waterhouse LLP.
Key topics that will be considered include:
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Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall, Ruxandra Cana, Indiana de Seze, and Michel Michaux
Lynn L. Bergeson
is managing director of Bergeson & Campbell PC, (B&C) a Washington, D.C. law firm focusing on conventional and engineered nanoscale chemical, pesticide, and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation, and associated business issues; principal of The Acta Group LLC and The Acta Group EU Ltd. with offices in Washington, D.C. and Manchester, UK; and president of B&C Consortia Management LLC (BCCM) with offices in Washington, D.C. BCCM is an affiliate of B&C, which has strong institutional experience in consortia management. BCCM provides cost effective administrative and management services to consortia to ensure their interests are protected and their voices heard on issues of concern. BCCM works with industry groups to develop or expand advocacy and/or product stewardship programs, to develop and conduct communications outreach to local, state, federal, or international government entities, to formulate and initiate research programs.
Lisa R. Burchi
is of counsel with Bergeson & Campbell PC, and has significant experience in domestic and international chemical and pesticide regulation and litigation. Burchi assists corporations in conducting corporatewide Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) compliance audits and manages various consortia on chemical-specific legislative and regulatory matters. Lisa is a co-author of “The TSCA Basic Practice Book,” ABA (2000) and “TSCA and the Future of Chemical Regulation” (2000). Lisa is a graduate of Tufts University (B.A., cum laude, 1990); The National Law Center, George Washington University (J.D., with honors, 1995).
Leslie S. MacDougall
is the director of regulatory affairs for The Acta Group LLC and The Acta Group EU, Ltd. Shehas extensive experience in chemical-related matters. Before joining Bergeson & Campbell PC, she was the Programs Manager for the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) Program and the International Council of Chemical Associations (ICCA) Initiative for the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) (1997-2006). During her tenure at EPA, Leslie functioned as a liaison for EPA, industry representatives, OECD, and OECD member country governments. Also, Leslie served as the U.S. representative on technical REACH-related issues; reviewed OECD and ICCA programmatic directives to formulate the U.S. position; performed peer review of assessments for test plans, dossier/robust summaries, and SIDS Initial Assessment Reports for individual chemical and categories; and functioned as an advisor to the High Production Volume Chemicals Branch Chief and Risk Assessment Division Director. Leslie performed health and environmental effects screening level assessments of existing chemicals in support of other office programs, which included: the High Production Volume Challenge Program (HPV Challenge Program), Toxic Substances Control Act (TSCA) Sections 4 and 8(e), the Risk Management 1 (RM1) process, and data evaluations on FYI submissions. After leaving EPA, Leslie established her own regulatory consultant business, M8, Inc., where she consulted with clients on international developments in chemical management, direct industry submissions under the OECD SIDS Program, TSCA Section 4 matters, and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)-related issues.
Ruxandra Cana is a partner in the Brussels office of Field Fisher Waterhouse LLP. She counsels multinational companies and industry associations on European regulatory compliance, consortia formation and product defense, including related litigation. She regularly represents clients before European institutions and national bodies and assists them with the development of advocacy strategies. Her areas of expertise include the European chemicals regulations (REACH) and EU rules related to cosmetics, medical devices, food (labeling, nutrition, food additives, genetically modified food) and consumer products such as electronics, reaching across many corresponding industry sectors. Her REACH expertise was acquired over the last 7 years, during which she advised clients on all the issues arising in relation to the new Regulation: company audits, corporate arrangements, supply chain questions, intra- and inter-companies agreements, discussions and negotiations with the European Commission, Member States Compentent Authorities, and European Chemicals Agency (ECHA). More specifically, Ruxandra acts as legal counsel to over 15 REACH consortia (dealing with all issues arising during such cooperation), regularly advises companies and associations on data sharing and SIEF agreements and provides further counseling related to notification of new substances (NONS) conversions, discussions with ECHA related to pre-registration and registration, enforcement actions, and the authorization process (comments on candidate list proposals, defense of exemptions and preparation of authorization applications).
Indiana de Seze
is a senior associate in the Brussels office of Field Fisher Waterhouse LLP. She
has been practicing competition & EU regulatory law since 1999 and has collaborated to a number of significant EU cases, notably in the areas of merger control, horizontal and vertical agreements, information sharing and cartel defense, anti-dumping and commercial arbitration. She has advised numerous clients on distribution, contractual arrangements, terms and conditions, pricing solutions, and in trade practice matters. She has developed particular expertise in competition advice to International trade associations, and a selection of EU regulatory and environmental areas such as waste - batteries, electronic waste (WEEE) and market access - eco-design, energy-using products, CE marking, hazardous substances in electronic goods (RoHS), chemicals, biocides and pesticides. Indiana regularly advises REACH clients and provides legal support for the management of REACH consortia. She has assisted prominent clients in the following sectors: chemicals, life sciences, transport, in particular air and rail, paper and pulp, consumer brands, telecommunications and retail. Indiana speaks French (native) and English fluently.
is a senior adviser in the Brussels office of Field Fisher Waterhouse LLP, where he is responsible for consortium formation and management. He currently manages 11 consortia set up for pesticide, biocide or REACH registrations, covering in excess of 150 different substances. Prior to joining FFW in 2007, Michel
worked for Cefic, beginning in 1989 as a counsellor in the Internal Market Affairs department where he was responsible for renewable Resources, Mineral Oil Taxation, and Energy policies until 1992, when he took up the responsibility of product safety issues in the Technical Affairs department. In 1996, he became responsible for the management of several sector groups, mostly dealing with inorganic chemicals. Between 2000 and 2006 he managed the Cefic Biocides Forum and consortia of companies registering jointly biocidal active substances. He is one of the co-authors of RIP 3-4 on data sharing, for which Cefic was associated with two other trade associations under the lead of a law firm. In 2006, he was assigned to launch the consortium management activities of ReachCentrum, a new service unit established as a subsidiary of Cefic.