| Case Study - FIFRA |
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A. Background on FIFRA
The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) is a United States federal law which set up the basic U.S. system of pesticide regulation to protect applicators, consumers and the environment. FIFRA established registration for all pesticides, which is only done after a period of data collection to determine the effectiveness for its intended use, appropriate dosage, and hazards of the particular material. Since 1970, the Environmental Protection Agency (“EPA”) has administered the FIFRA program.
B. The Issues
In certain circumstances, a pesticide applicant may rely on data previously submitted by another registrant “…if the applicant has made an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant, or, failing such agreement, binding arbitration under this subparagraph.” In these instances, disputes often arise over the appropriate amount of compensation an applicant should pay the original data submitter for use of the data.
C. The Analysis
Historical costs incurred by the original data submitter to develop the relied-upon data form the basis of the compensation amount in most cases. Internal costs are typically derived from employee time spent working on scientific studies conducted to develop relied-upon data. External costs typically include fees paid to contractors (labs, environmental consultants, etc.), outside of the original data submitter’s organization, engaged to develop relied-upon data.
Dispute Analytics has assisted multiple law firms and multinational companies with FIFRA data compensation analyses. Our firm uses audit-based techniques to analyze both supporting cost documentation and cost estimation methodologies. We have also assisted firms in developing spreadsheet models which logically compile and present historic costs. The linked structure of the models enables global changes to cost component variables, providing the ability to update costs efficiently while minimizing the possibility of error. Our team has provided expert testimony in FIFRA matters in multiple arbitrations.
