CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

Acta EU is a leading international specialist in chemical product approval, support, and regulatory defence.

With a global base in Washington, D.C. and a strategic business centre near Manchester, UK, Acta EU offers an international service for product registration, regulatory issues, and toxicology and is a “centre of expertise" for industry.

The Acta EU regulatory team provides project management for fast-track product approval by building support and defence packages for product portfolios.

Professional Personnel

Lynn L. Bergeson. Principal. Education: Michigan State University (B.A., magna cum laude); Columbus School of Law, Catholic University of America (J.D.). Ms. Bergeson has practiced chemicals regulation and occupational safety and health law for over two decades. She assists individual companies and a wide range of trade groups or ad hoc consortia on chemical-specific legislative and regulatory matters. Ms. Bergeson’s practice areas include TSCA, FIFRA, EPCRA, RCRA, CAA, CWA, OSHA compliance and litigation matters, and REACH. Ms. Bergeson is widely published and lectures frequently on regulatory and policy issues affecting chemicals under federal, state, and international regulatory programs.

Andrew Bourne. Regulatory Specialist. Mr. Bourne has significant experience in regulatory and chemical management matters. Previously, Mr. Bourne worked for Exponent International Ltd. (Exponent) as a Regulatory Affairs Specialist where he was a liaison for Substance Information Exchange Forum (SIEF) members, steering groups, and downstream users for the compilation of substance identification and available substance data and risk management information for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) phase-in 2010 deadlines. In addition, Mr. Bourne produced several Chemical Safety Reports (CSR) for Annex IX and X registrations and assisted in biocides and plant protection registrations. Prior to his work at Exponent, Mr. Bourne was a Regulatory Affairs Officer at Harlan Laboratories Ltd., where he managed non-phase-in and worldwide registrations and notifications of chemical substances and produced training documents for REACH. Mr. Bourne has a degree in environmental science and environmental management from the University of Derby.

Christopher R. Bryant.  Education:  University of Maryland (B.S. in Animal Science).  Mr. Bryant has over 20 years of experience in environmental, health and safety (EHS) compliance and legislative, regulatory and policy issues.  Previously, he was the Managing Director of the Chemical Products and Technology Division at the American Chemistry Council where he directed strategic efforts on improving support to the chemical industry.  He managed a broad array of issues, including federal and state legislative activities, product de-selection, and advocacy with EPA and state environmental agencies.  Prior to his tenure at the American Chemistry Council, Mr. Bryant consulted General Electric (GE) on EHS matters.  He assisted in the implementation of GE’s EHS management system across all GE business units.  He conducted EHS management system training sessions for GE business leaders, which led to significant improvement in GE’s EHS performance.  He also conducted audits, operating reviews, and management system reviews at GE facilities.  Additionally, he provided regulatory consulting on hazardous waste, hazardous materials transportation, clean air, and OSHA regulatory programs.  Mr. Bryant was formerly President of The Technical Group, LLC, which specialized in hazardous substance and OSHA matters.  He was the Director of EPA’s RCRA/Superfund Industrial Assistance Hotline and a field chemist with GSX Services, Inc. 

Ruth C. Downes.  Regulatory Specialist.  Ms. Downes specializes in REACH registrations and worldwide notifications, having registered many substances under REACH since 2008.  Ms. Downes is experienced with the European Chemicals Agency submission tools such as REACH-IT and the dossier creation tool IUCLID 5 (International Uniform Chemical Information Database), including its plug-in tools such as the Chemical Safety Report tool and the Technical Completeness Check tool.  Through the Notification of New Substances scheme and REACH, Ms. Downes has built strong links with national competent authorities and communicates frequently with the European Chemicals Agency.  She has worked as part of many Substance Information Exchange Forums and consortia supporting Lead Registrants in document preparation along with other activities to meet REACH-related registration deadlines.  Ms. Downes is a former Regulatory Affairs Associate at Harlan Laboratories Ltd (formerly SafePharm Laboratories) where she provided regulatory advice and produced regulatory dossiers and documents for REACH and worldwide notifications.

Leslie S. MacDougall. Education: Old Dominion University (B.S., 1988); The University of Maryland (post-graduate education in Toxicology, 1990); John Hopkins University (post-graduate education in Risk Assessment, 1992). Ms. MacDougall has extensive experience in chemical-related matters. Previously, she was the Programs Manager for the OECD SIDS Program and the ICCA Initiative for EPA’s Office of Pollution Prevention and Toxics (1997-2006). During her tenure at EPA, Ms. MacDougall functioned as a liaison for EPA, industry representatives, OECD, and OECD member country governments. Also, Ms. MacDougall 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. Ms. MacDougall 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), TSCA Sections 4 and 8(e), the Risk Management 1 (RM1) process, and data evaluations on FYI submissions. After leaving EPA, Ms. MacDougall 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 REACH-related issues.

R. David Peveler, Ph.D., born Savannah, Georgia. Education: Georgia Institute of Technology (B.S. in Chemistry, 1969); Rutgers University (M.B.A., 1984); Northwestern University (Ph.D. in Organic Chemistry, 1975; University of Maine (post-doctoral Fellowship). Dr. Peveler’s many areas of expertise include domestic and Canadian product regulatory compliance, FFDCA food contact and packaging matters, FIFRA product registration and labeling matters, DOT classification and labeling issues, and product safety (OSHA and WHMIS compliant MSDSs and labels). Dr. Peveler is familiar with the Systems, Applications and Products (SAP) enterprise resource planning software for the EHS module and the role it can play in support of regulatory compliance. Most recently, Dr. Peveler served as a consultant to Evonik Degussa Corporation and managed a variety of product regulatory compliance matters under TSCA, FFDCA, and related chemical product laws and regulatory programs with special emphasis on FDA regulations around bulk Active Pharmaceutical Ingredients, including Drug Master Files, Drug Establishment Registrations, Drug Product Listings, labeling and import requirements. Prior to his work with Evonik Degussa, Dr. Peveler was a Senior Regulatory Scientist with Chemtura Corporation, where he managed TSCA and Canadian Domestic Substance List (DSL) issues and chemistries, ranging from mineral oils to complex reaction products, a wide variety of FFDCA direct and indirect food contact matters, and DOT classification and training issues. Previously, Dr. Peveler was Chemtura’s predecessor in interest, Witco Corporation, R&D Group Leader where he directed a group of researchers in a variety of areas involving polymer additives including PVC heat stabilizers and polymeric plasticizers, and antioxidants for polyolefins.

Joseph E. Plamondon, Ph.D., born Dubuque, Iowa.  Education:  Loras College (B.S. in Chemistry); University of California at Berkeley (M.S. in Bio-organic Chemistry); University of California at Davis (Ph.D.).  Dr. Plamondon brings a wealth of experience in the regulatory arena and is well known in the industrial chemical community.  He has spent over 25 years working on TSCA matters and more recently on REACH.  Dr. Plamondon has extensive experience working within the regulated community in positions with the Rohm and Haas Company and Akzo Nobel, and has published a book based on his 25 years of experience entitled The Underlying Foundation of Science Used in the Regulation of Industrial Chemicals.  The book addresses chemical identity and nomenclature issues, along with risk assessment and toxicology, under both TSCA and REACH.  In addition to his work within the chemical industry, Dr. Plamondon has spent over ten years consulting with chemical companies on a broad range of TSCA issues.  Projects have included providing strategic preparation and submission of premanufacture notifications (PMN) designed to avoid TSCA Section 5(e) consent orders and other adverse regulations, as well as offering guidance to companies in the determination of whether certain health and safety information is reportable under TSCA Section 8(e).  Dr. Plamondon has presented at many conferences and professional meetings, e.g., the American Chemistry Council’s Global Chemical Regulations Conference (Living with TSCA), among others, and has spoken at major global REACH conferences sponsored by the Rapra group in Boston in April 2008, Houston in January 2009, and Amsterdam in June 2009, and a conference sponsored by Fresenius in Cologne in December 2009.  Dr. Plamondon had written extensively on chemical regulatory matters prior to the book publication.  Recent publications include TSCA and Engineered Nanoscale Substances, Nanotechnology Law and Business (2007) (co-author) and The DuPont TSCA Enforcement Action:  Implications for the Chemical Industry, Environmental Quality Management (2006).

Other Professional Resources

Nicole Harrison. Education: Masters in Science in Toxicology from the University of Surrey, United Kingdom; currently attending part-time the University of London, London School of Hygiene and Tropical Medicine (Pg. Diploma in Public Health (area of specialization: Environment and Health), 2007; MPH (Environment and Health), 2010). Ms. Harrison has significant experience in regulatory and chemical management matters. Recently, Ms. Harrison performed duties on behalf of Syracuse Research Corporation Incorporated as a regulatory toxicologist/environmental chemist responsible for supervising data entry and database management for EPA’s HPVIS and supervising the preparation of chemical data summaries, hazard characterizations, and toxicological profiles for human health and ecotoxicity issues for individual chemicals and chemical categories in support of EPA activities in the HPV Challenge Program, OECD SIDS Program, and TSCA Sections 4 and 8(e) projects. Previously, Ms. Harrison worked for the OECD in its EHS Division as a Consultant on various contracts. During her tenure at OECD, Ms. Harrison was responsible for assisting OECD Member countries, chemical companies, and industrial consortia with the review of toxicity data, to be used for conducting hazard and/or risk-based assessment of industrial chemicals. Fulfilling these duties required Ms. Harrison to interact with numerous scientists from national, regional, and international chemical programs, including EPA and the ECB, as well as industry regarding the assessment of hazards of HPV chemicals to human health and the environment. She also utilized available exposure-type information in an effort to assist them to make recommendations for necessary further actions to be taken to clarify and/or better manage a chemical’s potential risks. Ms. Harrison also critically reviewed and analyzed over 100 SIDS documents, which were submitted to the OECD Secretariat for assessment at SIAMs. These documents were assessed for scientific content (including toxicology, data consistency and quality, reliability, relevance, and adequacy), compliance with OECD data evaluation guidelines, and relevant Test Guidelines. She further analyzed more than 50 chemical reports as part of the ICCA initiative. As such, Ms. Harrison has experience in using IUCLID software. Ms. Harrison was responsible for all publication issues of finalized assessments of HPV chemicals, and in so doing, ensured that all toxicity data of the hazard/risk-based assessments were disseminated world-wide through the use of UNEP websites. To facilitate this process, she collaborated with scientists and representatives from UNEP Chemicals based in Geneva, Switzerland.

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