In making decisions on a company’s application to register pesticide active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA may make use of studies or data submitted earlier by another company to support the registration of a similar active ingredient.  This situation opens the door to data compensation and exclusive use protections. 

Specifically, under certain circumstances, the company that provided the EPA with the initial data may be entitled to compensation from the company submitting the second application.  Exclusive use is a higher form of protection that gives the data submitter the right to refuse to give the Agency permission to rely on its data in support of another entity’s registration. 

In a new guidance document, the EPA notes that making decisions about compensability and exclusive use treatment can be difficult.  The guidance reviews how decisions about compensation and exclusive use are made and gives examples of compensable and noncompensable data. 

15-year compensation period

Generally, studies submitted to support or maintain a FIFRA registration are compensable for 15 years from the date of submission to the EPA. The period for exclusive use treatment commences with EPA’s registration of the initial product containing a previously unregistered active ingredient and runs for 10 years (with a potential for extensions of up to 3 years with the addition of minor uses).

The EPA notes that most situations faced by Agency chemical teams involve data compensation, which is the focus of the guidance document.

Following are selections from the examples of compensable and noncompensable data provided in the guidance.

Compensable data

• Data submitted in support of a registration, which are used by the EPA to conclude that a study is not required for the same or another active ingredient
• Data submitted by a registrant that leads the Agency to the conclusion that a specific assessment is not needed but changes the regulatory outcome; i.e., leads to a label change
• Models built primarily using guideline studies submitted in support of registrations
• Studies EPA cites as the bases for default values, assumptions, or refinements to defaults that the Agency uses in lieu of requiring a study

Noncompensable data

• Data generated solely by the government or using government funds and models based on such data.
• Generally, studies conducted and submitted by the Department of Agriculture’s Interregional Research Project #4 (IR-4) program.  In “rare circumstances,” a study conducted under IR-4 is funded by a registrant, which may make the study compensable provided the registrant submits the study.  However, the EPA does not apply exclusive use protection to any study involving the use of government resources.
• Studies generated solely to support advancing the science, a new approach, or a methodology that is not submitted to support specific registration actions.  There are exceptions; for example, studies using the new methodology that are submitted in support of a registration are compensable.
• A circumstance involving EPA review of a large body of data where the Agency’s determination of future data needs is based primarily on EPA’s own assessment rather than on a particular guideline study or on a single or particular group of registrant studies.
• Data submitted by a registrant that leads the Agency to change the conclusions of a risk assessment without resulting in labeling changes or other changes to the FIFRA registration.
• Analysis or arguments submitted to support a waiver request.  However, individual studies cited in the analysis may be compensable.

Guidance on Data Compensation Considerations in Connection with Decisions to Waive Typical Data Requirements