Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of these global legal developments and take steps now to minimize legal, regulatory, and commercial risk.
As many know, PFAS are a group of synthetic organic chemicals. Thousands of chemicals are considered PFAS, and they are used to make an enormous variety of products that are designed to resist or prevent chemical reaction, including degradation. Dubbed “Forever Chemicals” because of their inherent resistance to degradation, these chemicals may accumulate in the environment; some also bioaccumulate. To complicate matters, there is no global consensus definition of PFAS, and international, federal, and state regulatory agencies have elected to define PFAS quite differently.
What We Do
- Chemical Product Review
- Identification of PFAS in chemical products and supply chains
- Chemical analysis for confirmation of PFAS
- Reporting obligations related to PFAS
- Labeling and notice requirements under international, federal, and state law and regulation
- Testing Program Management
- Toxicology, environmental fate, exposure and risk assessment, modeling
- TSCA test order support
- Study design
- Protocol/study plan development
- Study placement, including contracting with contract research organizations (CRO) and invoice management
- PFAS Legislative and Regulatory Updates
- Monitor and report on PFAS enforcement actions
- Monitor and report U.S. state PFAS legislation
- Monitor and report on global regulatory trends
- Communication of global regulatory status
- Advocacy for proposed regulation
- Product Life Cycle Analysis and Proposal of Alternatives
- Due diligence reviews
- Essential uses determination
- Potential liability awareness
- Marketing and response planning
- Litigation support
- Strategic Business Advice
- Map consumer/market PFAS developments and legal and industry mandates
- Planning and budgeting
- Supply Chain Communications
- Assist with managing supply chain inquiries from suppliers to customers
- Information gathering from import supply partners
- Preparation of and response to PFAS-related customer inquiries
- Assist with chemical identity of PFAS substances and compositional certifications
- Assistance with expanded reporting requirements
The professionals of B&C have unparalleled experience in scientific, legal, policy, and regulatory issues related to PFAS.
B&C Managing Partner Lynn L. Bergeson is an internationally recognized authority on chemical regulatory law and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters, and is a powerful advocate for clients before the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and other governance and standard-setting bodies. She has assisted 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.
Catherine Croke, DBA, Director of Product Stewardship and Regulatory Affairs, provides industry support regarding internal product stewardship and supply chain best practices as a certified compliance auditor and is a highly experienced professional with more than three decades of success executing product stewardship and regulatory compliance programs within global specialty chemicals and materials companies. Her expertise includes experience with enterprise resource planning, data maintenance, and necessary documentation to support regulatory compliance. Dr. Croke is a current Board Member of the Product Stewardship Society.
Carla N. Hutton, Regulatory Analyst, brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.
Because chemical legal and regulatory outcomes are grounded in science, B&C offers clients an unrivaled scientific advantage with our team of more than a dozen chemists, toxicologists, geneticists, and public health scientists, including seven with Ph.D.s.
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.
Todd J. Stedeford, Ph.D., DABT®, ERT, ATS, Of Counsel, delivers exceptional legal acumen and scientific experience to firm clients developed over a 20-plus year career spanning international laboratory research; corporate and federal legal appointments; industry health, safety, and environment (HS&E) positions; and scientific leadership of U.S. federal agencies. Dr. Stedeford most recently served as Senior Science Advisor/Senior Leader, OPPT, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA. Other positions Dr. Stedeford has held at EPA include Acting Chief, Chemical Risk and Reporting Enforcement Branch, Waste and Chemical Enforcement Division, Office of Civil Enforcement (OCE); and Chief of Assessment Branch 2 for New and Existing Chemicals, Risk Assessment Division, OPPT.
Lara A. Hall, MS, RQAP-GLP, is a staff Scientist with over two decades of experience in environmental research, study monitoring, quality assurance, and international regulatory support. Ms. Hall assists clients in placing and monitoring studies to assist with registration of new chemicals, pesticides, and biocides; developing test plans for chemicals that are subject to regulatory approval; and assessing studies for conformance with testing guidelines, data compensation, and regulatory and GLP requirements.
PFAS presence in global supply chains must be addressed carefully and thoughtfully. B&C’s global consulting affiliate The Acta Group (Acta®) affords clients effortless access to in-country expertise from offices in Washington, D.C.; Manchester, England; Brussels, Belgium; and Beijing, China; with partners and agents in many more countries. B&C and Acta work seamlessly together to provide clients with a coherent, strategic, and business-savvy worldwide PFAS game plan.
B&C® Consortia Management, L.L.C. (BCCM) manages 18 active consortia, providing core management services along the operational hierarchy so that members can focus on substantive issues most pertinent to their needs and essential to their success. BCCM can assist companies wishing to join an existing consortium or to form a new consortium related to PFAS compliance.
- B&C regularly assists clients with test plans to identify potential hazards of a PFAS and develop data to demonstrate safety of the substance.
- B&C professionals have assisted with differentiating different classes of PFAS for purposes of responding to proposed regulations.
- B&C has provided clients with expert compositional review and jurisdictionally relevant compliance strategies.
- B&C assists clients to respond to the TSCA Section 8(a)(7) rule regarding reporting and recordkeeping requirements for PFAS.
- Critically reviewed a specific PFAS substance to assess potential exposure to humans and the environment and designed a test plan in anticipation of product challenges.
- B&C professionals have followed and commented on U.S. state PFAS legislation. As more states promulgate regulation, continuing to monitor and provide client information allows decisions regarding commercial and legal implications of products in the market.