Chemical Regulation under TSCA
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 five former senior EPA officials, an extensive scientific staff, including six 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.
In addition to implementing the amendments to TSCA made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which was signed into law on June 22, 2016, and was immediately effective, EPA is exercising and interpreting its authority under TSCA in new, unprecedented, and creative ways. For instance, EPA is regularly issuing new regulations, many in the form of Significant New Use Rules (SNUR), among other game-changing initiatives, including the following:
- Significant changes to EPA's treatment and classification of confidential business information (CBI);
- Reliance on EPA's TSCA Work Plan for Chemical Assessments for prioritization purposes;
- Regulation of chemicals in articles; and
- Enhanced testing of existing chemicals.
It is imperative for companies whose businesses are implicated under TSCA both to understand clearly how these initiatives affect compliance, and to appreciate the competitive implications of these new and formidable regulatory challenges and opportunities. As with any new law, challenges are matched only by the commercial opportunities that change offers. TSCA reform is a true game-changer, and opportunities in the commercial space abound. With a thorough understanding of TSCA, its implementing regulations, and the general principles underlying the federal system for managing TSCA-related products, B&C is well-suited to address a company's needs, address challenges, and identify opportunities.
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 conventional and nanoscale chemicals and 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
- Persistent, Bioaccumulative, and Toxic (PBT) issues
- 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 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.
More information is available on our website, www.lawbc.com.