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Chemical Regulation under TSCATSCA FAQs Overview: Enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) has inspired renewed interest in and underscored the prominence of the Toxic Substances Control Act (TSCA). Lautenberg significantly amends and modernizes TSCA, and the U.S. Environmental Protection Agency (EPA) began immediately to implement the law’s many new provisions. For over a decade the scientists and regulatory specialists at The Acta Group (Acta®) have offered clients an unparalleled level of experience and excellence in matters relating to TSCA, making it the premier global consulting group to provide companies with deep, experienced, and expert TSCA assistance. Acta is headquartered in Washington, D.C., with additional offices in Manchester, England, and Beijing, China. Our TSCA practice group includes several former senior EPA officials, an extensive scientific staff, including seven Ph.D.s, and a robust and highly experienced team of regulatory and business consultants. One of our core businesses is assisting clients with TSCA Section 5 new chemical notifications and with broadening their business reach with marketing the new products made possible by a successful Section 5 notification. In addition to implementing the amendments to TSCA, EPA is exercising and interpreting its authority under TSCA in new, unprecedented, and creative ways. For instance, EPA is regularly issuing new regulations, many in the form of Significant New Use Rules (SNUR), among other game-changing initiatives, including the following:
It is imperative for companies whose businesses are implicated under TSCA both to understand clearly how these initiatives affect compliance, and also to appreciate the competitive implications of these new and formidable regulatory challenges. As with any new law, challenges are matched only by the commercial opportunities that change offers. TSCA reform is a true game-changer, and opportunities in the commercial space abound. With a thorough understanding of TSCA, its implementing regulations, and the general principles underlying the federal system for managing TSCA-related products, Acta is well-suited to address a company's needs, address challenges, and identify opportunities. Our Experience: Acta's deep and expansive understanding of TSCA is reflected in the many publications that quote our professionals on TSCA developments and the many seminars that request our participation. It is also reflected in our publications and training programs. We regularly conduct training courses (in our offices and at client sites) to facilitate TSCA compliance. Our professionals are unparalleled in their understanding of the regulatory construct and science policy implications of TSCA. Lynn Bergeson has earned an international reputation for her comprehensive mastery of TSCA and especially how it pertains to nanotechnology, biotechnology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure risk assessment, and risk communication. Sheryl Dolan, Heather Collins, M.S., and Barbara Christianson provide invaluable TSCA chemical notification and submission support services. Our professionals include a number of high-level EPA alumni, including:
Because TSCA is so grounded on chemistry, Acta has a robust team of professionals who possess both scientific and regulatory backgrounds and are uniquely able to address science-based regulatory issues that arise under TSCA. Acta's science professionals include David Peveler, Ph.D., an organic chemist whose understanding of chemical substances and TSCA identification issues is unmatched anywhere, and who has spent decades consulting with chemical companies on a broad range of TSCA issues. Dr. Jane Vergnes, Ph.D., DABT®, with a doctorate in Human Genetics and over 25 years of experience as a senior toxicologist and product steward with major global chemical companies, offers clients her expansive understanding of toxicological testing within the regulatory framework of TSCA, including study design, laboratory practices, and data requirements for new chemical introductions and existing chemical support. Brian Xu, M.D., Ph.D., DABT®, has over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies. He assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs. Dr. Xu's significant experience with EPA regulations and with the Orders and Decrees of the Chinese regulatory system helps him anticipate potential hurdles for clients registering or marketing products in both China and the U.S. Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering and in Technology Policy from the Massachusetts Institute of Technology. He has more than 25 years of experience in the field of risk assessment and is well-suited to assist clients before EPA when occupational and residential exposure issues are raised in the context of premanufacture notification (PMN) reviews. For more than a decade, Lara Hall, M.S., RQAP GLP, has been assisting clients in thinking through strategic and efficient chemical testing plans to support the introduction and maintenance of chemicals on a global scale. Karin Baron, M.S.P.H., has spent more than 20 years in the chemical and personal care industry and has extensive experience with assisting companies to achieve TSCA compliance, including managing SNURs, polymer exemptions and Inventory issues, Section 12(b) export notifications, and Section 8(c) and 8(e) recordkeeping and reporting. Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed TSCA compliance programs and coordinated teams focused on commercializing new products for a multinational chemical corporation. Dr. Burya specializes in PMN preparation, polymer exemption determinations, and import/export requirements. TSCA is just one piece of a global puzzle of chemical management laws that must be addressed thoughtfully and carefully; Acta offers clients seamless access to European and Asian chemical professionals to address the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, The Act for the Registration and Evaluation of Chemicals in Korea (K-REACH), China's Decrees No. 7 and No. 591, and other emerging chemical management laws in a coherent, strategic, and business-savvy manner. What We Do: Acta's professionals are highly experienced in regulatory and science policy issues following from TSCA compliance. We assist clients on a wide range of areas, including product approval, product review, and general compliance measures. Areas in which we advise clients include the following:
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