Registering new chemical products or expanding product registrations for existing chemical products to new markets involves strategic considerations and detailed administrative tasks. Regulations affecting chemical product approvals vary significantly from market to market. The U.S. Toxic Substances Control Act (TSCA), the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and the Chinese Provisions on Environmental Administration of New Chemical Substances are three prominent and distinct examples of major chemical regulatory schemes that companies in the chemical space must navigate. Failure to do so efficiently can be costly.
What We Do
Acta professionals are highly experienced in regulatory issues following from compliance with TSCA, REACH, China new chemical substance notifications (NCSN), and other regulatory programs. 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:
- New Substance Notification Services –
- Analyze notification schemes and develop notification strategies on a product-specific and market-specific basis.
- Design and coordinate testing programs to comply with notification requirements across markets, including developing non-testing methods such as Quantitative Structure Activity Relationship (QSAR) and read-across where possible
- Prepare notification dossiers
- Assist with reporting obligations for new and existing chemicals
- General Compliance Reviews –
- Assess whether client facilities are sufficiently staffed and equipped; prepare 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
- Section 5 Significant New Use Rules (SNUR)
- Section 6 chemical restrictions, including bans
- Assist clients with adherence to:
- Recordkeeping and Reporting Assistance –
- Assist clients with their recordkeeping and reporting requirements, SOPs, and systems development issues
- Update notification dossiers and fulfill other post-notification obligations as required in markets where a product has been certified
Acta professionals have experience in regulations affecting chemical product approvals under North American (U.S., Canada, and Mexico), EU, South American, Asian, and Pacific Rim regulatory programs. We regularly track significant legislative, administrative, and scientific initiatives that relate to the business of clients marketing chemicals and chemical products for multiple uses.
Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the complex legal, commercial, and scientific challenges presented by globalized chemical management programs, and especially how these regulatory programs pertain to nanotechnology, biotechnology, and other emerging transformative technologies. Ms. Bergeson assists multinational corporations, innovative start-ups, business consortia, and industry trade groups to develop efficient and sophisticated pathways to commercialization for new chemicals.
James V. Aidala is a former U.S. Environmental Protection Agency (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.
Karin F. Baron, MSPH, a regulatory consultant with more than 20 years of experience developing, implementing, and managing complex regulatory chemical compliance matters for some of the largest industrial and specialty chemical companies in the world, offers expert advice and guidance on regulatory matters involving REACH.
Emma Louise Jackson, delivers skilled global notification assistance, including classification and labeling of substances and mixtures, testing strategy advice, literature searching and reliability assessment, and compilation of regulatory documents, such as IUCLID 5 and Chemical Safety Reports (CSR). She is an excellent resource for preparation of Safety Data Sheets (SDS) and product labels, as well as liaising with various regulatory authorities.
David Peveler Ph.D. with a doctorate in organic chemistry, havs spent decades consulting with chemical companies on a broad range of TSCA issues, assist with substance identification issues in association with REACH, and has written extensively on chemical regulatory matters.
Richard E. Engler, Ph.D., is a 17-year veteran of EPA’s Office of Pollution Prevention and Toxics (OPPT). He assists clients with properly identifying chemicals, under various global nomenclature schemes, including complicated substances such as Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB) and using EPA’s tools for predicting physicochemical properties and ecotoxicity endpoints.
Jane S. Vergnes, Ph.D., DABT®, who holds a doctorate in human genetics, spent 25 years in global product stewardship at major international chemical companies, and is an expert at guiding clients through the international web of chemical regulations cost effectively.
Lara A. Hall, M.S.,RQAP-GLP, a scientist and Registered Quality Assurance Professional for Good Laboratory Practice (RQAP-GLP), offers clients a tremendous depth of experience with data development, fate and effects modeling, environmental risk assessment, and application/notification preparation to support new and existing registrations worldwide, including those required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and TSCA in the U.S., REACH and the Biocide Products Regulation (BPR) in the EU, and the Pest Management Regulatory Agency (PMRA) in Canada.
Scott J. Burya, Ph.D., a regulatory chemist with a Ph.D. in analytical chemistry, managed compliance and notification activities for a multinational coating manufacturer and has obtained PMNs, Food Contact Notifications (FCN), Letters of No Objection (LONO), and other approvals needed to commercialize new products. Dr. Burya helps clients navigate the technical, supply chain, and organizational aspects of regulatory submissions by providing strategic insights, monitoring analytical studies, and preparing dossiers.
- Acta routinely collects, prepares, and performs new chemical substance notifications (NCSN) for a variety of countries.
- Acta regularly counsels prominent multinational chemical manufacturers on the legal, regulatory, policy, and business implications of evolving TSCA, REACH, China NCSN, and other rulemaking initiatives to ensure product stewardship alignment.
- Acta has negotiated dozens of Enforcement Consent Agreements (ECA) under TSCA Section 4, resulting in diminished testing requirements.
- Acta, along with its affiliates Bergeson & Campbell, P.C. (B&C®) and B&C® Consortia Management, L.L.C. (BCCM), routinely counsels TSCA testing consortia on TSCA Sections 4 and 5 testing obligations and on voluntary product stewardship testing initiatives.
- Acta routinely counsels on issues pertinent to the management of confidential business information (CBI) under TSCA.
- Acta counsels clients on harmonizing global chemical product approval and testing programs under TSCA, REACH, China NCSN, and related chemical management programs.