(a) Purpose. The purpose of this part is to specify the kinds of data and information EPA requires in order to make regulatory judgments under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide products. Further, this part specifies the data and information needed to determine the safety of pesticide chemical residues under FFDCA sec. 408.

(b) Scope.

(1) This part describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process, e.g., as used in the registration review program; or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue.

(2) This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action.

(3) This part does not include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data.

(c) Scope of individual subparts.

(1) Conventional pesticides. Subparts A, B, C, D, F, G, K, L, N, and O apply to conventional pesticides.

(2) Biochemical pesticides. Subparts A, B and U apply to biochemical pesticides.

(3) Microbial pesticides. Subparts A, B and V apply to microbial pesticides.

(4) Antimicrobial pesticides. Subparts A, B, C, D, and W of this part apply to antimicrobial pesticides.

[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]