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With this final rule, EPA established exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. and codified at 40 CFR 174.26 and 174.27 and for the residues of such PIPs under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a and codified at 40 CFR 174.541 for certain PIPs that are created in plants using biotechnology. In this final rule, the term “exemption” is applied to actions under both of these statutes. (EPA notes that this action only exempts qualifying PIPs from regulation under FIFRA and the need to establish a tolerance for residues of qualifying PIPs under section 408(e) of the FFDCA; other statutory or regulatory requirements may still apply, e.g., State, Tribal, or local requirements). This rule provided criteria and definitions that identify the two groups of PIPs that are exempted through this action, called “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs,” and codifies the process through which the Agency determines their eligibility for exemption. The rule also codified the recordkeeping requirements for exempted PIPs.