M007 PRIA Fee Category

FIFRA Section 3(c)(1)(F)(ii) sets forth the criteria to be met for extending the exclusive use period. The threshold requirement is that the new minor use must be registered within the first 7 years of the commencement of the exclusive use period. FIFRA Section 3(c)(1)(F)(ii) states, in part:

The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after the date of enactment of this clause and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that –

1. there are insufficient efficacious alternative registered pesticides available for the use;
2. the alternatives to the minor use pesticide pose greater risks to the environment or human health;
3. the minor use pesticide plays or will play a significant part in managing pest resistance; or
4. the minor use pesticide plays or will play a significant part in an integrated pest management program.

FIFRA Section 2(ll) states, in part:

The term “minor use” means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where—

1. the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
2.  the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and
   1. there are insufficient efficacious alternative registered pesticides available for the use;
   2. the alternatives to the pesticide use pose greater risks to the environment or human health;
   3. the minor use pesticide plays or will play a significant part in managing pest resistance; or
   4. the minor use pesticide plays or will play a significant part in an integrated pest management program.”