How Will EPA Implement Data Compensation for Food-Use Inert Ingredients?
Lawrence E. Culleen Arnold & Porter Nearly seven years after the enactment of the Food Quality Protection Act, the Environmental Protection Agency (EPA) finally has solicited comments for the record concerning its plans for implementing Section 408(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA). See 68 Fed. Reg. 18977 (Apr. 17, 2003). When enacting Section 408(i) of FFDCA, Congress directed that EPA must provide inert ingredient data-submitters exclusive use and data comp-ensation to the same extent provided by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Sections 3 and 10. Thus, EPA has issued for comment a think piece which is only a marginally updated version of a draft that was informally circulated by the Agency to trade associations during September 2002 (which itself was a revision of a January 2000 Options Paper ). See 65 Fed. Reg. 2947 (Jan. 19, 2000). The current document presents and solicits comment on three options that EPA is considering as a fr