161.20—Overview.
(a) Legal authority.
These requirements are promulgated under the authority of sections 3, 5, 12, and 25 of the Federal Insecticide, Fungicide and Rodenticide Act, as amended (FIFRA) (7 U.S.C. 136-136y ).
(b) Purposes of this part.
(1)
The primary purpose of this part is to specify the types and minimum amounts of data and information the Agency requires in order to make regulatory judgments about the risks and benefits of various kinds of pesticide products under the criteria set forth in FIFRA sections 3(c)(5) (C) and (D) and 3(c)(7).
(2)
This part also specifies the types and minimum amounts of data and information the Agency requires to decide whether to approve applications for experimental use permits under FIFRA section 5.
(3)
Finally, this part specifies the types and minimum amounts of data and information that an applicant for registration, amended registration, or reregistration must submit or cite in support of an application in order to satisfy the requirements of FIFRA section 3(c)(1)(D) and sections 3(c)(5)(B) or 3(c)(7). Use of the term “registration” in this part will pertain to new registrations and amended registrations as well as reregistration accomplished under section 3(g), unless stated otherwise.
(c) Availability of related guidelines.
The data requirements for pesticide registration specified in this part pertain to product chemistry, residue chemistry, environmental fate, toxicology, reentry protection, aerial drift evaluation, wildlife and aquatic organisms, plant protection, nontarget insects, product performance, and biochemical and microbial pesticides. The standards for conducting acceptable tests, guidance on evaluation and reporting of data, further guidance on when data are required, definition of most terms, and examples of protocols are not specified in this part. This information is available in advisory documents (collectively referred to as Pesticide Assessment Guidelines) through the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (telephone: 703-487-4650).