On March 22, 2018. EPA published on its web site PR Notice 2018-1, titled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(II),” which provides guidance to registrants as to how the Agency determines a “minor use” as applicable to the registration of a pesticide. Specifically, PR Notice 2018-1 describes the Agency’s revised approach in evaluating “sufficient economic incentive” under FIFRA when determining the eligibility of a pesticide use for classification as a minor use. Under FIFRA Section 2(II), a minor use is defined as either: 1) the use of a pesticide on a crop for which the total acreage in the United States is less than 300,000 acres; or, 2) the use does not provide sufficient economic incentive to support the initial or continued registration of a pesticide. These provisions in FIFRA are intended to encourage the continuation of minor use registration of pesticides that might otherwise be discontinued for economic reasons alone. Under FIFRA, registrants of minor uses may receive a new or extended exclusive use period for data submitted in support of a minor use registration thereby providing the company an economic incentive to pursue new or existing minor use registrations and ensuring the availability of products used on low-acreage crops and other small-volume uses.
To date, EPA has relied on the guidance contained in PR Notice 97-2 in its interpretation of what constitutes an economic minor use – namely, the standard adopted in PR Notice 97-2 holds that a use is minor under FIFRA section 2(II) if gross revenues at full market potential do not cover the costs of registration including data generation, registration fees, and the cost of paperwork burden associated with the registration process. EPA, however, believes that the standard in PR Notice 97-2 does not consider all relevant factors for determining whether there is insufficient economic incentive to pursue a new minor use registration or continue to support an existing minor use registration.
EPA bases its revised methodology as set forth in PR Notice 2018-1 on the concept of the registration of a pesticide as being an investment. In so doing, EPA will consider:
- The difference in time between incurring costs of generating data for registration and obtaining revenue from product sales,
- The multiple years over which revenue is generated, and
- The costs of producing and distributing the product.
The Agency states that evaluating registration costs as an investment results in several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use and that each of these measures “provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.”
In its other provisions, PR Notice 2018-1 clarifies that minor use under FIFRA is based on acreage reported in the USDA Census of Agriculture.
A draft of PR Notice 2018-1 was published for public comment on June 6, 2016. Public comments received by the Agency and EPA’s response document may be accessed at www.regulations.gov (Docket identification number EPA-HQ-OPP-2015-0813).