161.100—How to determine registration data requirements.
To determine the specific kinds of data needed to support the registration of each pesticide product, the registration applicant should:
(a)
Refer to subparts C and D ( §§ 161.150 through 161.640). These subparts describe the data requirements, including data tables for each subject area. The corresponding subdivisions in the Pesticide Assessment Guidelines are listed in § 161.108.
(b)
Select the general use pattern(s) that best covers the use pattern(s) specified on the pesticide product label. Selection of the appropriate general use pattern(s) will usually be obvious. However, unique or ambiguous cases will arise occasionally. These situations may be clarified by reference to the Use Pattern Index presented in the appendix to the Data Requirements for Registration. The applicant can look up a specific use pattern in appendix A and it will be cross referenced to the appropriate general use patterns to be used in each Data Requirement table.
(c)
Proceed down the appropriate general use pattern column in the table and note which tests (listed along the left hand side of the table) are required (“R”), conditionally required (“CR”) or usually not required (“—”). After reading through each data requirement table, the applicant will have a complete list of required and conditionally required data for the pesticide product and the substance to be tested in developing data to meet each requirement. The data EPA must have available to review the registration of a specific product consists of all the data designated as required for that product and all the applicable data designated as conditionally required for that product.