Over the past decade or so, the concept of “product stewardship” has emerged as a defining standard against which to measure chemical product excellence. While the term has many definitions, some U.S. state environmental protection agencies refer to it as “the act of minimizing the health, safety, environmental, and social impacts of a product and its packaging throughout all lifecycle stages, while also maximizing economic benefits.”
A product-centered approach considers the entire life cycle of a product, from design, manufacture, and use to end-of-life. It involves the commercial value chain of all entities involved with a product’s manufacture, distribution, use, and end-of-life disposition. Bergeson & Campbell, P.C.’s (B&C®) extraordinary team of chemical product lawyers, scientists, and regulatory professionals makes it the premier resource for product stewardship services.
What We Do
- Risk Evaluation and Product Assessment
- Provide support via consortia management to respond to TSCA Test Orders
- Place and monitor studies for toxicology and ecotoxicology
- Perform quantitative non-cancer and cancer risk assessments
- Product Compliance
- Develop Standard Operating Procedures to ensure awareness of and compliance with regulatory requirements
- Map consumer/market demand and legal and industry mandates
- Plan and budget for new product entry to market
- Assist with recordkeeping and reporting
- Monitor and provide updates on legislative and regulatory developments
- Provide supply chain evaluation, communication, and compliance planning
- Chemical Product Approval and Review
- Assist in the global registration and approval of chemical products
- Assist with reporting obligations for new and existing chemicals
- Assist with labeling and safety data sheet (SDS) requirements
- Prepare evaluation of restrictions, bans, and phaseouts
- Management System Auditing
- Review existing documentation for compliance
- Provide regulatory reference for resolution and training
- Review exports and imports
- Review and support inventory compliance
- Sustainable Chemistry
- Propose strategic business advice
Our Experience
Our firm’s grounding in product stewardship is reflected in our team’s long tenure of participation in professional organizations advancing the goals of product stewardship. Managing Partner Lynn L. Bergeson is a past President of the Product Stewardship Society’s (PSS) Board of Directors, having served for years previously on the PSS Board. Ms. Bergeson assists multinational entities to develop and maintain sophisticated product stewardship programs premised on solid, forward-thinking corporate principles and newer, greener technologies that offer product performance and smaller environmental footprints.
Richard E. Engler, Ph.D., Director of Chemistry, is a former senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He holds a Ph.D. in physical organic chemistry and has participated in thousands of TSCA substance reviews, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases. Dr. Engler’s expansive understanding of the specific challenges and opportunities TSCA presents for PFAS chemistry is a powerful asset for clients during regulatory review.
Jane Vergnes, Ph.D., DABT®, Director of Toxicology, offers clients an agile, multi-disciplinary talent for problem-solving honed during her 25 years of global product stewardship experience with Fortune 500-listed companies. Todd J. Stedeford, Ph.D., DABT®, ERT, ATS offers exceptional legal and scientific experience with a 20-plus year career as a former leader at the U.S. Environmental Protection Agency (EPA) and corporate and federal legal appointments. Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, has managed global hazard communication programs for major industrial and specialty chemical companies. Scott J. Burya, Ph.D., Regulatory Chemist, assists clients in all stages of product development from prototype development and regulatory approvals to end-of-life product management. Lara A. Hall, MS, RQAP-GLP, Scientist, has a wide array of technical and quality assurance experience well suited to assisting clients in the development of effective product stewardship strategies and ensuring scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide. Heather F. Collins, M.S., Regulatory Consultant, has an extensive project management background developing and managing environmental, health, and safety (EHS) compliance matters. She has managed global product safety and hazard communication groups and established training programs to ensure applicable laws and regulations were followed, while supporting new chemical submissions.
B&C’s U.S. team is augmented by the professionals of our international consulting affiliate, The Acta Group (Acta), with offices in the United Kingdom and the European Union, and partners and agents in Asia and South America. The B&C and Acta partnership offers clients comprehensive product stewardship compliance planning and execution across the global supply chain and in all regions in which clients wish to launch or maintain successful products.
Representative Engagements
- Conducted a review of an international product stewardship management system for a global client
- Researched client chemical substance list to identify future global bans and restrictions
- Provided workflows for product recall under FFDCA
- Guided client on per- and polyfluoroalkyl substance (PFAS) language to use to gather data on presence in sourced products
- Prepared public comments on behalf of clients for draft TSCA risk evaluations and proposed TSCA risk management regulations
- Prepared hazard and risk assessments to demonstrate to TSCA new chemical reviewers that a battery electrolyte is not likely to present an unreasonable risk
- Assisted client with negotiating TSCA regulations that provide necessary protections while minimizing commercial impacts
- Advised client on pros and cons of various research and development (R&D) options
- Supported industry by forming and supporting chemical-specific consortia
- Prepared an overview of existing global PFAS regulations
- Assisted multinational company with business planning activities for a substance of very high concern (SVHC)
- Assisted consortium with high-profile substance regarding marketing and response to misinformation