The ACTA Group, L.L.C.

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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 over a decade, 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; Manchester, England; and Beijing, China.

Our TSCA practice group includes several former senior EPA officials, an extensive scientific staff, including six Ph.D.s, and a robust and highly experienced team of regulatory and business consultants. One of our core businesses 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 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, Acta is well-suited to address a company’s needs, address challenges, and identify opportunities.

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, and Lisa R. Burchi have worked on virtually every aspect of TSCA and achieved many successes for Acta clients over the years. Sheryl Lindros Dolan, 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 over two decades, and offers significant value in addressing chemical policy and related issues;
Charles M. Auer, former Director of the Office of Pollution Prevention and Toxics (OPPT); Mr. Auer offers a wide portfolio of expertise, including regulatory compliance requirements for new and existing chemicals, nanoscale materials, and intergeneric microorganisms;
Christopher R. Blunck, former Policy Analyst and Special Assistant to the Director of OPPT; Mr. Blunck managed or participated in the development of hundreds of TSCA and Toxics Release Inventory (TRI) Program regulations, guidance documents, and policy papers during decades of involvement in the regulatory development process at EPA;
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; and
Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in 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.

Because TSCA is so grounded on 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.

Karin F. Baron, M.S.P.H., has spent over 20 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.

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 Premanufacture Notification (PMN) preparation, polymer exemption determinations, and import/export requirements.

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

Jason E. Johnston, M.S., holds two Master of Science degrees in Chemical Engineering Practice and in Technology and 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 PMN reviews.

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

R. David Peveler, Ph.D., an organic chemist whose understanding of chemical substances and TSCA identification issues is unmatched anywhere, has spent decades consulting with chemical companies on a broad range of TSCA issues.

Kathleen M. 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.

Jane S. Vergnes, Ph.D., DABT^®, a toxicologist 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.

J. 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 United States.

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.

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
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:

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.