Exemption From the Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic Act for Residues of Nucleic Acids that are Part of Plant-Incorporated Protectants (Formerly Plant-Pesticides)

The substances plants produce for protection against pests, and the genetic material necessary to produce these substances, are pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), if humans intend to use these substances for "preventing, destroying, repelling or mitigating any pest." These substances, produced and used in living plants, along with the genetic material necessary to produce them, are also "chemical pesticide residues" under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA calls these substances along with the genetic material necessary to produce them, "plant-incorporated protectants." In this final rule, EPA exempts from the FFDCA section 408 requirement of a tolerance, residues of nucleic acids that are part of a plant-incorporated protectant. Nucleic acids are ubiquitous in all forms of life, have always been present in human and domestic animal food and are not known to cause any adverse health effects when consumed as part of food. EPA believes there is a reasonable certainty that no harm will result from aggregate exposure to residues of nucleic acids that are part of a plant-incorporated protectant.