Michael Novak joined Keller and Heckman in 2001. Mr. 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), TSCA, EPCRA and other federal and state regulatory programs.
Mr. Novak has expertise in pesticide regulatory 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; enforcement issues; import and export requirements; tolerance petitions, including the approval of inert ingredients; and the treated-article exemption. Mr. Novak also drafts and negotiates business contracts for pesticide clients, including distributorship, supply, subregistration (licensing), and registration/data transfer agreements.
As lead counsel, Mr. Novak has successfully obtained settlement of pesticide or chemical enforcement actions brought by U.S. EPA Headquarters (Washington D.C.), EPA Region III (Philadelphia, PA), EPA Region IV (Atlanta, GA), EPA Region V (Chicago, Ill.), EPA Region IX (San Francisco, Cal.), the California Department of Pesticide Regulation and the New York Department of Environmental Conservation. From 2003 to 2005, Mr. Novak obtained resolution of five separate Stop Sale Use and Removal Orders issued by EPA against clients alleging the unlawful sale of a pesticide under FIFRA.
Mr. Novak has unique and extensive experience defending clients in enforcement actions brought by U.S. EPA under FIFRA's Good Laboratory Practice Standards (GLP), which prescribe practices for conducting studies that support pesticide registration. In 2003, Mr. Novak successfully obtained outright dismissal of two of the six total enforcement actions brought nationwide by U.S. EPA under FIFRA's GLP Standards. These decisions involved no payment of monetary penalty or notice of warning. In 2002, Mr. Novak settled a similar GLP matter by obtaining an 85% reduction in the monetary penalty sought by EPA.
Before entering private practice, Mr. Novak served as General Counsel for Riverdale Chemical Company and as Director of Regulatory Affairs for the Chemical Producers and Distributors Association (CPDA).