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.”