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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 over two decades, the scientists and regulatory specialists at The Acta Group (Acta®) have offered clients an unparalleled level of experience and excellence in matters relating to TSCA, making it the premier global consulting group to provide companies with deep, experienced, and expert TSCA assistance. Acta is headquartered in Washington, D.C., with additional offices in Brussels, Belgium and Manchester, England.
What We Do
Acta’s professionals are highly experienced in regulatory and science policy issues following from TSCA compliance. 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
Our Experience
Acta’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.
Our professionals are unparalleled in their understanding of the regulatory construct and science policy implications of TSCA. Lynn L. Bergeson, Lisa M. Campbell, Lisa R. Burchi, and Kelly N. Garson have worked on virtually every aspect of TSCA and have achieved many successes for Acta clients over the years. 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; Mr. Aidala has been closely involved with TSCA legislative reauthorization and key regulatory matters for more than two decades, and he offers significant value in addressing chemical policy and related issues and
- Richard E. Engler, Ph.D., former senior staff scientist in OPPT and leader of EPA’s Green Chemistry Program; Dr. Engler 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.
Because TSCA is so grounded in chemistry, Acta has a robust team of 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., a toxicologist with a Ph.D. in Human Genetics, Lara A. Hall, M.S., RQAP-GLP and Alexander E. Howard, M.S., who assist clients with strategic and efficient chemical testing plans, and Karen L. Lorusso, who assists 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; 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
- Acta regularly assists prominent multinational chemical manufacturers on the regulatory, policy, and business implications of evolving TSCA rulemaking initiatives and their international analogues to ensure product stewardship alignment.
- Acta, and its consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), routinely assist TSCA testing consortia on TSCA Sections 4 and 5 testing obligations.
- Acta has been a pioneer in addressing the imposition of TSCA regulation on nanoscale chemical substances and assists domestic and international nanoscale chemical product manufacturers on TSCA SNUR and related initiatives.
- Acta routinely assists on issues pertinent to the management of CBI under TSCA.
- Acta assists clients with harmonizing global chemical product approval and testing programs under REACH, TSCA, and related chemical management programs.