Product Stewardship

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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.

B&C has long been deeply engaged in product stewardship activities and has a deep bench of product stewardship professionals. Our core business platform is rooted in our institutional belief in and commitment to address all aspects of chemical product law, science, and regulation to ensure our clients are provided a seamless and comprehensive approach to commercializing, supporting, and managing chemicals and the industrial, commercial, and consumer products that contain them.

Risk Evaluation and Product Assessment

The skills and disciplines called upon to ensure the deployment of the highest standards of product stewardship align perfectly with the resumes of B&C’s professionals. Product risk assessment and evaluation involve a deep dive into a chemical’s toxicological and environmental fate properties and the conditions of use that drive exposure assessments. Our skilled team of over a dozen scientists, including four Ph.D. chemists and toxicologists, offers an unparalleled array of skills in this regard.

Product Compliance and Risk Management

Another critical element of product stewardship is product compliance and risk management. The professionals of B&C are second to none in their deep and expansive knowledge of chemical product law, regulation, and policy. Our lawyers are highly skilled practitioners and offer extensive experience with all aspects of federal and state domestic chemical law, regulation, and product risk. Their legal expertise is informed by our team of scientists and regulatory specialists. Our elite practice areas in the Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), biobased and nano-based chemicals, and beyond offer a truly comprehensive set of legal, policy, and regulatory skills that inform and guide the best product stewardship assets a client could want.

Management System Auditing and Training

B&C’s professionals offer premier services in educating and counseling clients in building auditing capabilities in their product stewardship management programs or auditing systems already in use. The new normal requires awareness of value chain considerations, including manufacturing, processing, reporting, conditions of use, and complying with requirements related to product manufacture use and end-of-life conditions.

Our staff also regularly conducts assessments of management systems related to product stewardship to identify areas needing improvement, performs key gap analyses, and provides training to ensure our clients’ professionals are confidently able to discharge their product stewardship responsibilities.

B&C’s TSCA Tutor^® training platform provides online, on-demand webinar training modules designed to offer expert, efficient, and essential TSCA training regarding required compliance and recordkeeping. Training in other chemical programs is also available.

Chemical Substance Evaluation and Substitution

Planned reviews of product stewardship practices within a company’s operations are imperative and increasingly the norm for best-in-class performance. Evaluating pending and existing restrictions and bans and selecting alternatives can be a complex process. Substitutions should consider both performance and economic feasibility. Evaluation of alternatives includes consideration of suitable alternatives that offer excellent performance with diminished exposure impacts.

Our professionals can assist in evaluating chemical inventories to ensure any implemented or planned restrictions or phaseouts are addressed globally, alternatives are considered, and evaluation of cost and market value are included in the decision-making process to ensure sustainability and market access.

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 S. Vergnes, Ph.D., Senior Toxicology and Regulatory Advisor, 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. 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, M.S., RQAP-GLP, Senior Regulatory Scientist/Quality Assurance Specialist, and Alexander E. Howard, M.S., Toxicologist/Regulatory Scientist, ensure scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide.

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. Heather F. Collins, M.S., Regulatory Consultant, has an extensive project management background developing and managing environmental, health, and safety (EHS) compliance matters. Kelly N. Garson, Senior Associate, represents clients in managing legal and regulatory issues that are faced when bringing new products to market and maintaining compliance with federal and state requirements, including for substances listed on the National List of Allowed and Prohibited Substances under the U.S. Department of Agriculture (USDA) organic regulations.

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 Federal Food, Drug, and Cosmetic Act (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

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