Global Chemical Notification Programs
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. U.S. chemical regulation under the Toxic Substances Control Act (TSCA), the European Union (EU) regulation under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation, and Chinese regulation under the Provisions on Environmental Administration of New Chemical Substances are three prominent and distinct examples of major regulatory schemes companies in the chemical space must navigate. Failure to do so efficiently can be costly.
Developing the right approach from market to market requires sound knowledge of its authorities and how to work within their regulatory programs. The Acta Group (Acta®), with offices in the U.S., Europe, and China, manages chemical products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry.
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 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 develop efficient and sophisticated pathways to commercialization for new chemicals.
James 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, M.S.P.H., a regulatory consultant with more than 15 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.
Leslie MacDougall brings extensive experience in global regulatory chemical control programs, including ten years at EPA. Among many other roles, Ms. MacDougall served as the U.S. representative on technical REACH-related issues, and as a liaison among EPA, the Organization for Economic Cooperation and Development (OECD), and OECD country governments. Ms. MacDougall provides expert assistance to clients regarding compliance matters and assistance in preparing and submitting registrations for new and existing chemicals in the more than 40 countries in which Acta operates. A recognized leader in international chemical control legislation, Ms. McDougall speaks often at global conferences and has been published in Chemical Regulation Reporter and Daily Environment Report.
Regulatory Specialist Ruth Downes-Norriss provides expert counsel on EU regulatory matters, in particular on activities falling under REACH. Ms. Downes-Norriss has been involved in REACH registrations and notifications since shortly after the program took effect. Her involvement from early on in the program's history has won her important contacts with authorities, including the European Chemicals Agency (ECHA) and national helpdesks.
Regulatory Specialist Gyöngyi (Pearl) Németh, M.Sc., a tri-lingual (English, German, Hungarian) with a Masters degree in Environmental Engineering and a post-graduate degree in Experimental Toxicology, delivers considerable international experience solving complex regulatory registration, commercialization, and compliance issues.
Emma Louise Jackson, CBiol MSB, 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.
Louise Boardall provides experienced support to Acta's regulatory specialists in the technical areas of physical chemistry and analytical methods, efficacy, toxicology, and ecotoxicology. She is also proficient in dossier preparation, data assessment, statistics packages such as SPSS and STATA, and utilization of national authority websites and databases.
Drs. David Peveler and Joseph Plamondon, both with doctorates in organic chemistry, have spent decades consulting with chemical companies on a broad range of TSCA issues, assist with substance identification issues in association with REACH, and have written extensively on chemical regulatory matters.
Dr. Richard Engler holds a Ph.D. in physical organic chemistry and 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 UVCBs; and using EPA's tools for predicting physicochemical properties and ecotoxicity endpoints.
Dr. Susan Youngren, who has a Ph.D. in environmental biology, has more than 30 years of experience in the field of risk assessment and is well-suited to assist clients before EPA when exposure issues are raised in the context of premanufacture notification (PMN) reviews.
Dr. Jane Vergnes, DABT®, who holds a doctorate in human genetics, spent 25 years in global product stewardship at major international chemical companies, and is expert at guiding clients through the international web of chemical regulations cost effectively.
Brian Xu, M.D., Ph.D., DABT®, is a board-certified toxicologist with an M.D. in pathology, a Ph.D. in pharmacology and toxicology, and over 15 years of experience developing and managing regulatory compliance for consumer products, pharmaceuticals, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Fluent in English and Mandarin, Dr. Xu has significant experience with FDA and EPA regulations and the Orders and Decrees of the Chinese regulatory system, making him a powerful asset to clients registering or marketing products in either jurisdiction.
Lara 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 FIFRA and TSCA in the U.S., REACH and BPR in the EU, and PMRA in Canada.
Andrew Burgess brings to Acta his extensive knowledge of international chemical control legislation and regulatory affairs. While Mr. Burgess' experience extends from China to Europe, he currently concentrates on matters through Acta's practice in China. He advises clients on chemical registrations, preparation of dossiers and chemical safety assessments (CSA), as well as post-submission matters. Mr. Burgess has been deeply engaged in China chemical registration and support activities for the last six years and has gained unique insights and knowledge of the legislation and its practical implications for businesses.
Our Asian team includes Yang Ni, based in Beijing, China, who serves as clients' on-the-ground guide to expanding their markets to China. His office provides research and development testing as well as regulatory support to multinational pharmaceutical and industrial chemical conglomerates. For these companies, Mr. Ni's knowledge of Chinese regulations, and his longstanding relationships with the appropriate contacts, is instrumental to his clients' success. Acta has additional staff and partners in Shanghai, Nanjing, and Xi'an, China, and Seoul, South Korea, to ensure clients have access to highly skilled, in-country chemical experts familiar with local regulatory practices, customs, and government agencies.
What We Do:
Acta professionals are highly experienced in regulatory issues following from compliance with TSCA, REACH, China REACH, 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
- Voluntary Children's Chemical Evaluation Program (VCCEP) 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
- 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 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.