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 more than 25 years, Bergeson & Campbell, P.C. (B&C®) has offered clients an unparalleled level of experience and excellence in matters relating to TSCA, making it the premier Washington, D.C. law firm to provide companies with deep, experienced, and expert TSCA assistance.
Our TSCA practice group includes four former senior EPA officials, an extensive scientific staff, including four Ph.D.s, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well-versed in all aspects of TSCA law, regulation, policy, and litigation. One of the core aspects of our business 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.
What We Do
TSCA law and lore is highly nuanced, and clients rely on B&C’s decades of internationally recognized and acclaimed legal, regulatory, scientific, and business counsel. 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:
- Chemical Product Approval and Review –
- Assist in the approval and regulation of industrial chemical products, including those enabled by nanotechnology and biotechnology
- Assist with reporting obligations for new and existing chemicals
- Assist with developing robust voluntary pollution prevention statements
- General Compliance Reviews (across TSCA Provisions) –
- Assess whether client facilities are sufficiently staffed and equipped; prepare TSCA compliance manuals and standard operating procedures (SOP); conduct in-house training seminars
- Specific Regulatory Reviews –
- Assist clients with adherence to:
- PMN/Microbial Commercial Activity Notice (MCAN) requirements
- PMN requirements pertinent to products of nanotechnology and engineered nanoscale materials
- TSCA nomenclature issues related to biobased chemicals and fuels
- Section 5 SNURs
- Section 6 chemical restrictions, including bans
- Assist clients with adherence to:
- Recordkeeping and Reporting Assistance –
- Assist clients with their Section 8(a), (d), and (e) recordkeeping and reporting requirements, SOPs, and systems development issues
- Additional Sample Matters –
- Export issues
- Inventory issues
- Polychlorinated biphenyl (PCB) issues
- Mercury issues
Our Experience
B&C’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 books, such as New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, published by the American Bar Association. We regularly are asked to conduct training courses to facilitate TSCA compliance for clients, professional organizations, and industry groups. B&C legal professionals are unparalleled in their understanding of the law and policy of TSCA.
B&C legal professionals are unparalleled in their understanding of the law and policy of TSCA. Lynn L. Bergeson, Lisa M. Campbell, Lisa R. Burchi, and Kelly N. Garson have worked on virtually every aspect of the law and have achieved many successes for B&C clients over the years. Non-lawyer professionals Heather F. Collins, M.S. and Barbara A. Christianson provide invaluable TSCA chemical notification and submission support services.
Our professionals include a number of high-level EPA alumni, including James V. Aidala, former EPA Assistant Administrator for Toxics under the Clinton Administration, and Richard E. Engler, Ph.D., former senior staff scientist in OPPT and leader of EPA’s Green Chemistry Program.
This impressive team offers clients an unmatched wealth of experience in TSCA regulatory and legislative matters.
Because TSCA is so grounded in chemistry, B&C has a robust team of non-lawyer professionals who possess both scientific and regulatory backgrounds and are uniquely able to address science-based legal issues that arise under TSCA, including Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, Jane S. Vergnes, Ph.D., DABT®, a toxicologist with a Ph.D. in Human Genetics, Lara A. Hall, M.S., RQAP-GLP, who assists clients with strategic and efficient chemical testing plans, and Karin F. Baron, M.S.P.H. and Karen L. Lorusso who assist companies with supply chain communication.
TSCA is just one piece of a global puzzle of chemical management laws that must be addressed thoughtfully and carefully; B&C’s global consulting affiliate, The Acta Group (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 Order No. 12 and Decree No. 591, and other emerging chemical management laws in a coherent, strategic, and business-savvy manner.
Representative Engagements
- B&C regularly counsels prominent multinational chemical manufacturers on the legal, regulatory, policy, and business implications of evolving TSCA rulemaking initiatives and their international analogues to ensure product stewardship alignment.
- B&C regularly assists clients with preparation of robust new chemical notices under TSCA Section 5 (e.g., PMNs, Significant New Use Notices (SNUN, and low volume exemptions (LVE)), with careful review of EPA risk assessment work products, and with negotiating consent order terms.
- B&C has negotiated dozens of Enforcement Consent Agreements under TSCA Section 4, resulting in diminished testing requirements.
- B&C and its consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), routinely counsel TSCA testing consortia on TSCA Sections 4 and 5 testing obligations.
- B&C has been a pioneer in addressing the imposition of TSCA regulation on nanoscale chemical substances and counsels domestic and international nanoscale chemical product manufacturers on TSCA SNURs and related initiatives.
- B&C successfully worked with EPA to withdraw a proposed TSCA Section 6 ban on two chemical substances.
- B&C routinely counsels clients on issues pertinent to the management of CBI under TSCA.
- B&C counsels clients on harmonizing global chemical product approval and testing programs under REACH, TSCA, and related chemical management programs.