The Knowledge Congress Has Scheduled a Live Webcast on FIFRA: Finding a Balance Between the Incentive to Innovate with Research and Development Costs

New York, NY, July 02, 2010 --(PR.com)-- The Federal Insecticide Fungicide and Rodenticide Act ("FIFRA") governs the regulation, sale, distribution, and use of pesticides in the United States. Under FIFRA, to register a pesticide the U. S. Environmental Protection Agency (“EPA”) must determine that the pesticide will perform its intended function without harm to human health or unreasonable adverse effects on the environment. The EPA relies on third party-produced studies, tests, and other data to make such decisions. To balance the incentives to conduct R&D for new, improved pesticides with entry considerations, a company seeking a new registration may cite data (via a cite-all or a selective citation method) that appear in the public literature and/or were previously submitted to the EPA by an original data submitter. FIFRA requires that if a prospective registrant relies on an original submitter’s data in support of a pesticide registration, the prospective registrant offer to compensate to the original data submitter based on a 15 year compensability period. If the parties are unable to reach a voluntary agreement as to the amount of compensation owed, a binding arbitration under the procedures of the Federal Mediation and Conciliation Service may be initiated by either party to resolve the dispute.

FIFRA does not explicitly define compensable “costs” nor does it provide a standard formula for determining the compensation a prospective registrant should pay for citing to or relying upon data generated by another entity in support of its application. Prior FIFRA arbitrations only provide guidance as to how some arbitrators have resolved the issue of cost sharing in a given data compensation dispute and do not serve as binding precedents. Given the nature of the pesticide regulatory process and FIFRA arbitrations, the unique facts and complex circumstances of each case are critical in determining the relevant components of the compensation award. One must carefully craft developing accurate and defensible data compensation claims under FIFRA. Live webcast, a panel of distinguished professionals will help you understand the most critical issues which will include:

- Determining the most reliable, comprehensive, and contemporaneous business records to use in measuring the costs of generating a pesticide

- Overcoming hurdles of limited or incomplete records

- Assess the appropriate adjustments allowed under FIFRA Timing issues

- Allocating costs between parties

- Live interactive Q&A session

The Knowledge Group is producing a Live webcast that will provide professionals with interest in research and development, environmental regulation, and law with a comprehensive overview of FIFRA data compensation and a keen understanding of its economic intent. This webcast will also discuss other arenas in which lawmakers and industry participants are faced with the same challenges of balancing innovation and R&D expenditures (i.e. pharma).

Speakers/Faculty Panel

Stefanie Perrella, Senior Analyst, NERA Economic Consulting

B. David Naidu, Partner, K&L Gates LLP

Roger R. Martella, Jr., Partner, Sidley Austin LLP

Claudia M. O'Brien, Partner, Latham & Watkins LLP

For updated list of the faculty panel, please visit: http://www.knowledgecongress.org/event_2010_Fifra.html

About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series

The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. “We bring together the world's leading authorities and industry participants through informative two-hour webcast that study the impact of changing regulations and help businesses succeed through proper regulatory compliance.”

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