Protection of Proprietary Data Rights for Data Used to Support Tolerance Exemptions for Inert Ingredients

In 1996 Congress amended section 408(i) of the Federal Food, Drug and Cosmetic Act (FFDCA) to provide both exclusive use and data compensation protections for data that inert ingredient manufacturers submit to EPA to establish or maintain tolerances or tolerance exemptions for these ingredients.  

• Exclusive use protection applies to data submitted to EPA to establish the first tolerance or tolerance exemption for a chemical and extends for the 10-year period following the establishment of that initial tolerance or tolerance exemption.
• Data compensation rights apply to all data submitted to EPA to support or maintain a tolerance or tolerance exemption and extend for the 15-year period following submission of the data.

EPA protects these rights by ensuring that pesticide formulators applying for registration or amended registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) either:

• use as a source of an inert ingredient a supplier that has satisfied applicable data submission obligations for that inert ingredient; or
• submit or cite such data themselves.

When previously submitted exclusive use data are cited, the citation must be accompanied by the authorization of the original data submitter or the person to whom such rights have been transferred.  In the case of compensable data, the citation must be accompanied by an offer to pay compensation. See Elements of an Offer to Pay for the Use of Inert Ingredient Data.

The submission or citation of public literature data does not confer any exclusive use or compensation rights under either FIFRA section 3(c)(1)(F) or FFDCA Section 408(i) (see Federal Register August 1, 1984;) (49 FR 30884, 30895-96)(FRL 2618-8))

The InertFinder database provides a list of approved inert ingredients. It identifies those chemicals that have data rights and lists the associated data owners. Data compensation rights belonging to all of the Cluster Support Teams (CST) have expired or been waived; therefore, there are no longer data rights associated with any of the CSTs.

The “Proposal for Implementing Data Compensation Rights for Data Submitted in Support of Tolerance and Tolerance Exemption Actions.” provides more detailed information on how EPA protects proprietary rights for inert ingredient data.