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 framework for implementing Section 408(i). Option I would provide compensation rights only to registrants and applicants whom submit tolerance data for actions undertaken pursuant to FIFRA Section 3 (registration, reregistration, etc.). Option II would provide compensation rights to any person whom submitted tolerance-related data for actions undertaken pursuant to FIFRA Section 3. Option III would extend data compensation rights to any person who submitted such data in support of a tolerance or exemption whether or not the data are submitted in the context of a registration or reregistration action taken under FIFRA. Option III is the only option that is intended to provide such protections for inert manufacturers who are not themselves pursuing a registration action.

The April 2003 proposal reflects the results of EPA’s contemplation of comments received in reply to its January 2000 Options Paper. Only nine commenters submitted remarks during 2000; eight of whom supported Option III which extended data compensation rights to any data submitter, regardless of whether the submitter was an applicant or registrant, or whether the data was required for a pesticide registration action. They supported Option III for one or both of the following reasons:
(1) the expansion of data protection rights would encourage further development of inert ingredients; and (2) data protection should not be enjoyed exclusively by participants in the product registration process. Only the law firm of Keller & Heckman argued that Option I was the most appropriate for EPA to implement. The firm argued that Congress did not intend to expand compensation rights to inert manufacturers and EPA did not have the authority to expand such rights itself.

The new document makes clear that EPA does not plan to use notice and comment rulemaking procedures to implement the expanded data compensation program. Thus, it appears that EPA will likely issue guidance documents, revise various administrative forms and update existing Pesticide Registration (PR) Notices to implement any changes necessitated by Section 408(i). Although it might make a compensation system for inert ingredients included in food-use products simpler to administer, the EPA document states that the Agency does not believe it has the authority to develop a licensing program for inerts. At this time, it is not clear how EPA will require applicants for food use registrations to show that they have the authorization of the original data submitter when they seek to rely upon a tolerance or exemption for inert ingredients used in their formulations.

EPA hopes to receive comments not only on the central options, but also on a myriad of administrative issues EPA likely will face as it attempts to implement Section 408(i). Comments must be submitted by July 16, 2003.