Who We Are
Michael S. Wenk
Mr. Wenk has been directing regulatory affairs at Fortune Global 500 chemical and consumer product firms since 1997. He pairs extensive regulatory expertise with a well-developed understanding of corporate operations, providing a highly unique blend of business operations knowledge and technical acumen to clients globally.
Mr. Wenk holds a bachelor’s degree in Human Ecology, with a focus on Government Affairs, from Rutgers University, a master’s degree in Environmental Science from Rutgers University/The New Jersey Institute of Technology, from which he graduated cum laude, and an MBA degree from the University of Maryland.
Throughout his 25 years in industry, Mr. Wenk has maintained close interaction with various internal corporate business units and services to develop sound regulatory strategies for a wide variety of products, including several novel applications. Specifically, these processes have involved identifying key regulatory issues within recognized Asia Pacific, South American, Middle Eastern and European markets, developing cost-benefit analyses for situations where multiple registration and regulation options exist, recommending the most viable path forward to ensure successful registration, and negotiating with local authorities, testing laboratories, and consultants for data provision.
Through his travels to over 25 countries, Mr. Wenk has managed face-to-face discussions with authorities, allowing for resolution of various issues in a positive manner for both parties. He maintains a pool of key resources, such as law firms, toxicology laboratories and in-country resources to further help to register products rapidly.
Mr. Wenk’s areas of expertise include:
Managing regulatory due diligence evaluations for corporate acquisitions, with particular experience in acquisitions over $100 million USD.
FIFRA registrations and management issues, including data compensation, Reregistration Eligibility Decisions (REDs), managing toxicology and ecotoxicology testing with third parties using OECD and other methodologies, report interpretation and dissemination and drafting FIFRA-compliant labels and other documentation based on the foregoing;
Food contact requirements of 21 CFR 176.170 et seq, having prepared and filed multiple Food Contact Notifications (FCN) with the U.S. Food and Drug Administration, as well as with the Canadian Food Inspection Agency (CFIA) and Health Canada (Health Products and Food Branch, “No Objection Letters”);
The registration of chemical substances and consumer goods throughout Asia Pacific, Latin and South America, the Middle East, and South Africa; and
A wide range of other areas, such as compliance auditing under FIFRA 6(a)(2), RCRA hazardous waste management, product stewardship program management, and training on a wide range of topics.
Mr. Wenk is a globally recognized expert on chemical substance regulations in Central and South America and the Middle East. His most recent handbook, “Chemical Regulation in the Middle East”, was published by John Wiley and Sons in 2018.
In addition, he has published a textbook on European Environmental Auditing (“The European Union’s Eco-Management and Audit Scheme (EMAS)”), which has been part of the curriculum at Bath Spa University, Newton St Loe, Bath, United Kingdom. Finally, he is the published author of over a dozen peer-reviewed professional journal articles, and has both chaired and presented at a wide variety of regulatory conferences in countries such as Canada, China, Greece, Hungary, Mexico, South Korea, Spain, Switzerland, Turkey, and the United States.