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Michael
T.
Novak
Partner
Washington, DC
Mike Novak
©2024 Keller and Heckman LLP

Michael (Mike) Novak practices environmental and business law for chemical manufacturers and other clients, including agricultural, antimicrobial, and biochemical pesticide producers. His practice focuses on the regulation of pesticides and other chemicals under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); the Toxic Substances Control Act (TSCA); the Emergency Planning and Community Right-to-Know Act (EPCRA); and other federal and state regulatory programs.

Mike has extensive knowledge and experience in issues associated with product registration, including the registration of biochemicals and unique technologies; petitions to cancel or deny registration; data compensation matters; adverse effects reporting; U.S. Environmental Protection Agency (EPA) enforcement; import and export requirements; tolerance petitions, including the approval of inert ingredients; and the treated-article exemption. He drafts and negotiates business contracts for clients, including distributorship, supply, sub-registration (licensing), and registration/data transfer agreements. Further, Mike has experience advising clients on advertising claims and strategies compliant with FIFRA and the Federal Trade Commission (FTC) Act.
 
As lead counsel, Mike has successfully obtained settlement of enforcement actions brought by the EPA Headquarters (Washington, DC) and many of the EPA regional offices, as well as the California Department of Pesticide Regulation, and the New York Department of Environmental Conservation. He has also obtained resolution of numerous Stop Sale Use and Removal Orders issued by EPA against clients alleging the unlawful sale of a pesticide under FIFRA.

Before entering private practice, Mike served as General Counsel for Riverdale Chemical Company and as Director of Regulatory Affairs for the Chemical Producers and Distributors Association (CPDA).

Representative Matters

  • Successfully defended a treated article seller and manufacturer before the Federal Trade Commission for alleged misleading claims under the FTC Act
  • Reached favorable settlement of several enforcement cases brought by CA DPR for the alleged sale of fertilizers as unregistered plant growth regulators
  • Obtained the first FIFRA section 18 emergency exemption for a new active ingredient approved to provide residual control of SARS-Co-V2 in Delta Airline planes, terminals, and kiosks
  • Successfully petitioned EPA to revise its guidance on minimum risk pesticides to clarify that residential use products used in or around food do not require a tolerance or tolerance exemption under the FFDCA. See Need for Tolerances and Tolerance Exemptions for Minimum Risk Pesticides | US EPA  
  • Advocated before a mediator to successfully persuade EPA HQ to dismiss a complaint seeking to levy a penalty of $65,000 for a hospital disinfectant alleged not to be efficacious under EPA’s Antimicrobial Testing Program (ATP)
  • Successfully persuaded EPA HQ to dismiss complaints in two separate matters alleging violations of EPA’s Good Laboratory Practices Standard (GLP)
  • Submitted comments in response to EPA’s Human Studies Rule to obtain exclusion of combination sunscreens and insect repellents

Education

University of North Carolina, B.A., 1989
University of South Carolina School of Law, J.D., 1992