PRACTICES

Chemical Product Stewardship

Overview:

Product stewardship -- the safe and effective management of chemicals throughout their lifecycle -- is not only environmentally responsible, it is increasingly requested by the public and required by governments worldwide.

To address public concerns, governmental pressures, and competitive demands, participants in the chemical manufacture process must be proactive in managing and monitoring their products to minimize risk and safeguard the public from health and environmental hazards. Developing, maintaining, and helping evolve responsible product strategies are critical to the success of companies in the chemical space.

The Acta Group (Acta®) professionals are well versed in global initiatives focusing on product stewardship and relevant regulations from governing agencies worldwide. We are well-positioned to help companies take charge of their products’ lifecycles and minimize health, safety, and environmental risks.

Our Experience:

Acta's global presence, with offices in North America, Europe, and Asia, is key for our clients. We operate in the spaces where the most regulatory and voluntary stewardship initiatives are underway so we can easily keep our finger on the pulse of developments that may impact client companies.

Our European Union (EU)-based team includes Emma Louise Jackson, CBiol, MSB, who develops testing strategies and manages projects for clients under global chemical compliance schemes in Australia, Canada, China, India, Japan, Korea, Malaysia, New Zealand, the Philippines, and Taiwan. She is also highly-experienced in managing supply chains, downstream user communications, and Substance Information Exchange Forum (SIEF) and consortium activities under the EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Louise Boardall supports the activities of our EU team and assists with dossier preparation, data assessment, and other regulatory registration activities.

Our U.S.-based team of seasoned scientific and regulatory professionals includes Lynn Bergeson, who has assisted multinational entities develop and maintain sophisticated product stewardship programs premised on solid, forward thinking corporate principles and newer, greener technologies that offer product performance and smaller environmental footprints. Jane Vergnes, Ph.D., DABT®, offers clients an agile, multi-disciplinary talent for problem-solving honed during her 25 years of global product stewardship experience with Fortune 500-listed companies. Whether assisting clients with new and existing chemical reviews, risk assessment and hazard communication, or compliance with chemical regulatory programs, including the EU's REACH and the Toxic Substances Control Act (TSCA), Dr. Vergnes deploys the full depth of her scientific, business, and policy knowledge to resolve clients' challenges. 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 international safety testing, risk assessment, product safety, and regulatory compliance for consumer products, pharmaceuticals, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Fluent in English and Mandarin, Dr. Xu works with clients to place, manage, and monitor toxicological and clinical tests and ensures Good Laboratory Practices (GLP) at laboratories in the U.S. and China; supports the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification and implementation; and oversees the preparation of dossiers in English or Chinese.

Also based in the United States, Karin Baron, MSPH, has managed global hazard communications programs for major industrial and specialty chemical companies. Lara Hall, M.S., RQAP GLP, has a wide array of technical and quality assurance experience well-suited to assisting clients in the development of effective product stewardship strategies and ensuring scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide. Sheryl Dolan assists clients with chemical notification and submission support, compliance counseling, management system support, auditing, and assistance with testing placement. Kathleen Roberts, an affiliate of Acta, is a well-recognized expert on chemical control regulations, particularly under TSCA. She is highly regarded as a leader in domestic and international science and policy program management for industry groups engaged in legislative and regulatory advocacy, research, and public outreach and communications. Molly Blessing assists with dossier preparation and data assessment for chemical product approval under global chemical control programs. She is experienced with assessing chemicals for risk of regulation to help companies minimize business risk from manufacture or use of hazardous products and processes.

Lauren Graham, Ph.D., an affiliate of Acta, utilizes her background in science communication to assist industry groups engaged in legislative and regulatory advocacy, testing and compliance, and public outreach and communications.  Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in EPA’s Office of Pollution Prevention and Toxics (OPPT), contributes his deep understanding of Agency processes and expert scientific support in the areas of hazard and risk assessment for chemicals being reviewed pursuant to TSCA and other federal, state, and international chemical control authorities.

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 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:

  • Chemical Product Approval and Review –
    • Assist in the approval and regulation of chemical products
    • Assist with reporting obligations for new and existing chemicals
    • Assist with labeling and notice requirements
  • Recordkeeping and Reporting Assistance
  • Regular Updates on Legislative and Regulatory Developments
  • Marketing and Response
  • Strategic Business Advice –
    • Map consumer/market demand and legal and industry mandates
    • Planning and budgeting
  • Additional Sample Matters –
    • Export issues
    • Inventory issues

Representative Engagements:

  • Assist multinational company with business planning activities for a substance of very high concern (SVHC).
  • Assist consortium with high profile substance regarding marketing and response to misinformation.
  • Assist multinational company with strategic business advice regarding placing high profile products on the market.
 
THE ACTA GROUP, L.L.C.
2200 Pennsylvania Ave, N.W. Suite 100W | Washington, D.C. 20037 | (202) 266-5020 | actagroup.com
© 2017 The Acta Group All Rights Reserved