TSCA Developments 2024

Nidia Mariana Calvo Mendez joined Enhesa Product Intelligence's Expert Services team as Managing Analyst almost 3 years ago. She oversees regulatory content and service relating to products in the Americas, and coordinates the global analyst team from her base in Guadalajara, Mexico. Prior to joining Enhesa Product Intelligence, Nidia spent her career in industries conducting regulatory analysis and risk management mainly for Latin America. She also has experience in TSCA, GHS, performing audits, and obtaining ISO 140001 certification

Prior to joining Chemical Watch News & Insight in 2015, Kelly managed regulatory affairs for several trade groups in the building products industry. Her academic background is in English and Spanish.

Michal Ilana Freedhoff is the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), effective June 2021. Prior to that, she joined EPA as the Principal Deputy Assistant Administrator for OCSSP in January 2021.

Alexandra (Alex) Dunn is a Partner in the Environmental, Safety, and Incident Response group at the international law firm of Baker Botts with 27 plus years of practice at the local, state, and federal levels of government. Her deep relationships across the nation and reputation for transparency, fairness, and equity, make her an effective presence in the difficult settings. Alex works with companies of all sizes – from multi-national corporations to startups – and with national organizations on environmental justice and risk communication, sustainability, the regulation and management of emerging contaminants, chemical regulations, enforcement and compliance assistance, and risk communication. .

Dr. Passarella is an expert strategist in navigating international chemical regulations.  At Intertek, she uses her chemical and legal experience and skill at interpreting complex chemical regulations to design and implement effective policies to protect client’s products.  During her career, Dr. Passarella has advocated for sustainable chemical management to enable the manufacture and sale of products in US and global markets. After completing her Ph.D. in chemistry, she formulated products, managed R&D groups, and managed global Product Stewardship and Sustainability. It was during this time that she pursued a law degree at night school, and is licensed to practice law in New Jersey and Pennsylvania.  Her combination of industry experience, and an in-depth knowledge of chemistry and the law enables her to translate regulatory trends and requirements into business and compliance action plans.

Michael Boucher is a partner at the law firm of Steptoe LLP in Washington, D.C. and a graduate of the Georgetown University Law Center. His practice encompasses all aspects of regulation, compliance, and enforcement under the Toxic Substances Control Act.

John J. Kowalski is a Certified Hazardous Materials Manager (CHMM) and an expert in Toxic Substances Control Act (TSCA) regulations. In his current role as a regulatory affairs lead at UL Solutions, John manages a team responsible for maintaining TSCA-related content in UL Solutions’ regulatory database, developing and providing TSCA-related training, and helping customers across different industries with TSCA compliance. This includes, but is not limited to, preparing Section 5 notices and Section 8 reports using the Environmental Protection Agency’s (EPA’s) Chemical Information Submission System and Central Data Exchange.

As Vice President of the American Chemistry Council’s (ACC) Regulatory and Scientific Affairs Division, Kimberly oversees the development of ACC’s policy positions in response to regulatory and legislative proposals. She also leads a staff of experts to identify, analyze and create technical and policy materials to serve as the foundation for ACC’s activities.

W. Caffey Norman’s environmental practice focuses on the regulation of hazardous chemicals by the Environmental Protection Agency, the Occupational Safety and Health Administration, the Consumer Product Safety Commission, and various state regulatory agencies. He has been particularly active in the subject areas of toxic substances, stratospheric ozone depletion, and global warming. For many years he has developed and successfully implemented strategies to defend products targeted for phase out or use reduction. He has participated in EPA rulemakings to regulate hazardous substances under all the environmental statutes and has initiated legislative and judicial review of a number of EPA regulations. Mr. Norman has also represented industry task forces in connection with pesticide registration and the negotiation of test rules and testing consent orders. Mr. Norman has successfully challenged a number of regulations in the U.S. Courts of Appeals.

ob Sussman is the principal in Sussman and Associates, a law and consulting firm that offers advice and support on energy and environmental policy issues to clients in the non-profit and private sectors.  Bob serves as counsel to Safer Chemicals Healthy Families (SCHF), a coalition of non-profit environmental and public health groups.

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), the European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Food Quality Protection Act (FQPA), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels clients on a wide range of issues pertaining to product stewardship; chemical hazard, exposure, and risk assessment; risk communication; minimizing legal liability; and product lifecycle strategy.

Robert F. Helminiak is the Vice President of Legal and Government Relations with the Society of Chemical Manufacturers & Affiliates (SOCMA), where he leads the association's advocacy efforts to effect positive change and outcomes for the specialty and fine chemical industry. 

Based in Washington D.C., Melanie Rybar supports Enhesa Product Intelligence as the expert on North America regulatory content. She has spent her career in the chemical manufacturing industry, conducting regulatory analysis, risk management reviews, developing new products and processes for companies making surfactants, functional polymers and other specialty chemicals intended for use in consumer products.

Harvey Joseph Clewell III, PhD, DABT, ATS, is a Principal Consultant with Ramboll US Corporation, located in Research Triangle Park, North Carolina.  He has more than 45 years of experience in environmental quality research, toxicology research, chemical risk assessment, and hazardous materials management, and has authored more than 200 peer-reviewed scientific publications and book chapters.