161.101—Required vs. conditionally required data.
(a)
Data designated as “required” (“R”) for products with a given general use pattern are needed by EPA to evaluate the risks or benefits of a product having that use pattern unless the data requirement has been waived under § 161.45 for that particular product or unless the product is covered by a specific exception set forth in a note accompanying the requirement.
(b)
Data designated as “conditionally required” (“CR”) for products with a given general use pattern are needed by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the corresponding notes accompanying the data requirements table. As indicated in the notes, the determination of whether the data must be submitted is based on the product's use pattern, physical or chemical properties, expected exposure of nontarget organisms, and/or results of previous testing (e.g., tier testing). Applicants must evaluate each applicable note to determine whether or not conditionally required data must be submitted as indicated by the conditions and criteria specified in the accompanying notes unless the Agency has granted a waiver request submitted by the registrant in accordance with § 161.45.
(c)
For certain of the required or conditionally required data, the “R” or “CR” designations and are enclosed in brackets (i.e., [R], [CR]). The brackets designate those data that are required or conditionally required to support a product when an experimental use permit is being sought. In all other situations (i.e., other than support of an experimental use permit), the brackets have no meaning and the designations R and CR are equivalent to [R] and [CR], respectively.