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, DC), EPA Region III (Philadelphia, PA), EPA Region IV (Atlanta, GA), EPA Region V (Chicago, IL), EPA Region IX (San Francisco, CA), 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). News, Events & Articles News Dec 02, 2011, Azim Chowdhury edits FDLI's "Tobacco Regulation and Compliance: An Essential Resource" publication Events May 24, 2011, Register Today! What U.S. Companies Need to Know: How to Manage the Regulatory Hurdles of TSCA, FIFRA & FDA Oct 29, 2008, CPDA Pesticide Registration Workshop Mar 20, 2008, Nanotechnology: The Future of EHS Regulatory Policy Conference Oct 23, 2007, A Practical Primer on Pesticides Register Today: Practical Primer on Pesticides Articles Jan 19, 2012, EPA Reveals Environmental and Sustainable Technology Evaluations Project for Microbial Resistant Building Products Sep 29, 2011, EPA Pesticide Enforcement to Focus on Imports and Supplemental Distribution Aug 02, 2011, June 2011 National Academies Meeting On Sustainable Development of Algal Biofuels Highlights Water Consumption at Commercial Scale Jul 25, 2011, Top Science, Trade, and Regulatory Advisors Set the Tone for Securing US Lead in Nanotechnology Regulation and Take Aim at EPA Pesticide Office Proposal Mar 11, 2011, The Constantly Pending PMN: Low Volume Exemption Applications Are Living Documents Feb 15, 2011, EPA Proposes to Strengthen Rule on Human Testing that Involves Pesticides Sep 23, 2010, EPA Targeting Retailers Under FIFRA Sep 20, 2010, Environmental Business Alert: End-of-Year Deadline to Nominate Existing Chemicals for Taiwan Inventory Nears Oct 22, 2009, Nanosilver, Nanomaterials EHS Research in the Regulatory Spotlight Again Nov 15, 2006, Environmental Business Alert Aug 10, 2005, Pesticide Alert August 2005 May 25, 2005, Biotechnology/Nanotechnology Alert Feb 10, 2005, Should EPA Implement the GHS for Pesticide Products? Nov 23, 2004, It's Time to Change EPA's Treated Article Exemption Oct 06, 2003, Advanced TSCA Concepts and Training: The Law and the Science; Seminar Manual Jun 24, 2003, Pesticide Alert June 24, 2003 Court Decision on Human Testing Could Affect PR Notices Jun 20, 2003, Pesticide Data Compensation Services Jun 01, 2003, Environmental Reporting and Recordkeeping: Sound Strategies and Legal Insights May 12, 2003, Pesticide Alert May 12, 2003 EPA to Develop Standards on Use of Human Testing Apr 21, 2003, Selling and Licensing Safety Data Apr 26, 2002, EPA Issues Draft PR Notice on False and Misleading Pesticide Brand Names Jan 09, 2002, BNA, Inc. Food Safety Report - A Proposed Framework to Regulate Inert Ingredients in Pesticide Formulations Jan 07, 2002, BNA, Inc. Daily Environment Report - A Proposed Framework to Regulate Inert Ingredients in Pesticide Formulations Oct 23, 2001, TSCA Inventory: Names Must Be Changed For Monomer and Isostearic Acid |