EPA Announces Improvements to Protect the Rights of Data Owners and Ensure Compliance with Data Compensation Rules

EPA is announcing a final rulemaking to improve protection for data submitters, and a new guidance for EPA risk managers to improve compliance assurance.  EPA expects that these changes will lead to greater efficiencies in the registration process, allowing applicants to benefit from greater clarity regarding when data compensation procedures should apply.

Final rule to improve protection for data submitters

Under the Federal Insecticide, Fungicide, and Rodenticide Act, to obtain a registration for a pesticide product, applicants are required to submit or cite data as part of the application, or cite data in the agency’s databases. To cite previously submitted data, the applicant generally must either receive permission from or offer to compensate the original data submitter.

Revisions are final to 40 CFR Part 152 Subpart E, now titled “Satisfication of Data Requirements and Protection of Data Submitters’ Rights.” This final rule addresses procedures for the protection of the exclusive use and data compensation rights of registrants submitting data to EPA as part of the pesticide registration process.

This final rule updates and clarifies the requirements regarding the citation of previously submitted data. This rule contains only minor amendments to existing regulations and in large measure simply brings EPA’s regulations in line with several statutory changes to FIFRA over the past 25 years. The revisions do not impose any new requirements or changes in activities that would increase cost or burden.

EPA sought public comments on the proposed rules from stakeholders in 2010. These comments were considered during the finalization of the rule.

New guidance for EPA risk managers to improve compliance assurance.

The new guidance, titled “Guidance on Data Compensation Considerations in Connection with Decisions to Waive Typical Data Requirements,” complements the guiding principles for data compensation outlined last May. The new guidance will help risk managers more efficiently meet EPA’s obligations to ensure applicants and registrants comply with requirements for data compensation and exclusive use of data under FIFRA. This guidance does not represent any change in EPA policy and instead improves the ability of risk managers to ensure compliance.