M008 PRIA Fee Category

FIFRA Section 3(c)(1)(F)(vi) applies to data submitted to add a minor use to an existing registration after the initial data exclusivity period expires. It provides for a new exclusive use period for data generated by an applicant or registrant to register a new minor use. It allows registrants to request at the time they submit their application for a new minor use (the use does not have exclusive use protected data) that the data be given exclusive use protection.

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.”