Chemical Regulation under TSCA

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Overview:

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 seven 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 many amendments to TSCA, 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 also to appreciate the competitive implications of these new and formidable regulatory challenges. 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 these companies' needs.

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 publications and training programs. The American Bar Association published our book on TSCA. We regularly conduct training courses to facilitate TSCA compliance. B&C legal professionals are unparalleled in their understanding of the law and policy of TSCA. Lynn Bergeson, Lisa Campbell, Tim Backstrom, and Lisa Burchi have worked on virtually every aspect of the law and achieved many successes for B&C clients over the years. Non-lawyer professionals Sheryl Dolan, Heather Collins, M.S., and Barbara Christianson provide invaluable TSCA chemical notification and submission support services.

Our professionals include a number of high-level EPA alumni, including:

• James 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 over two decades, and offers significant value in addressing chemical policy and related issues;
• Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in the Office of Pollution Prevention and Toxics (OPPT); with a Ph.D. in organic chemistry, Dr. Hernandez offers expert scientific support in the areas of hazard and risk assessment of chemicals being reviewed pursuant to TSCA and other federal, state, and international chemical control authorities;
• Richard 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;
• Tim Backstrom, former Senior Counsel in EPA's Office of General Counsel (OGC) working on pesticide, toxic substances, and air quality issues; Mr. Backstrom offers an extraordinary understanding of how EPA operates, as well as established relationships with many key players at EPA; and
• Charles Auer, former Director of OPPT; Mr. Auer offers a wide portfolio of expertise, including regulatory compliance requirements for new and existing chemicals, nanoscale materials, and intergeneric microorganisms.

This impressive team offers clients an unmatched wealth of experience in TSCA regulatory and legislative matters.

Because TSCA is so grounded on 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.

B&C’s science professionals include Joseph Plamondon, Ph.D., and David Peveler, Ph.D., organic chemists whose understanding of chemical substances and TSCA identification issues is unmatched anywhere, and who have spent decades consulting with chemical companies on a broad range of TSCA issues.

Jane Vergnes, Ph.D., DABT®, with a Ph.D. in Human Genetics and over 25 years of experience as a senior toxicologist and product steward with major global chemical companies, offers clients her expansive understanding of toxicological testing within the regulatory framework of TSCA, including study design, laboratory practices, and data requirements for new chemical introductions and existing chemical support.

Brian Xu, M.D., Ph.D., DABT®, has over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies. He assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs. Dr. Xu's significant experience with EPA regulations and with the Orders and Decrees of the Chinese regulatory system helps him anticipate potential hurdles for clients registering or marketing products in both China and the U.S.

Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering and in Technology Policy from the Massachusetts Institute of Technology. He has more than 25 years of experience in the field of risk assessment and is well-suited to assist clients before EPA when occupational and residential exposure issues are raised in the context of premanufacture notification (PMN) reviews.

For more than a decade, Lara Hall, M.S., RQAP-GLP, has been assisting clients in thinking through strategic and efficient chemical testing plans to support the introduction and maintenance of chemicals on a global scale.

Karin Baron, M.S.P.H., has spent 15 years in the chemical and personal care industry and has extensive experience with assisting companies to achieve TSCA compliance, including managing SNURs, polymer exemptions and Inventory issues, Section 12(b) export notifications, and Section 8(c) and 8(e) recordkeeping and reporting.

Molly R. Blessing provides technical support to companies working to achieve TSCA compliance through chemical data analysis and expertise in chemical nomenclature. Ms. Blessing is experienced with determining TSCA reporting obligations of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials (UVCB) and other complex chemical intermediates and products.

Kathleen Roberts is a recognized TSCA expert with over 25 years of experience in engaged advocacy, compliance, and communication activities with industry and EPA staff. In June 2013, Ms. Roberts was invited to provide expert testimony on understanding the history and impact of TSCA before the U.S. House Energy and Commerce Subcommittee on Environment and the Economy.

Karen Lorusso is a highly-experienced product safety professional who has assisted companies with TSCA Inventory issues and polymer exemptions to achieve TSCA compliance.

Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed TSCA compliance programs and coordinated teams focused on commercializing new products for a multinational chemical corporation.  Dr. Burya specializes in PMN preparation, polymer exemption determinations, and import/export requirements.  

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 Decrees No. 7 and No. 591, and other emerging chemical management laws in a coherent, strategic, and business-savvy manner.

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
    • Voluntary Children's Chemical Evaluation Program (VCCEP) 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
• 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

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 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.