The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. 136 et seq.) requires the U.S. Environmental Protection Agency (EPA) to promulgate, in accordance with Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 346a), maximum permissible levels (tolerances) for pesticide residues that raw agricultural commodities and processed food may legally contain. Under FFDCA, EPA has established tolerances that vary based on the commodity for more than 350 pesticide active ingredients (40 C.F.R. Part 180). Tolerances and the process for establishing them have received scrutiny from pesticide manufacturers, agricultural entities, and various environment and public health organizations. This issue arose again in the context of a recent EPA decision to not revoke chlorpyrifos tolerances. This example is discussed below.
The statutory standard for setting tolerances, last amended by the 1996 Food Quality Protection Act (FQPA; P.L. 104-170), is for there to be "reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue." FFDCA requires EPA to ensure that this standard applies to infants and children. Tolerances may only be established, modified, or revoked following FFDCA and Administrative Procedure Act (5 U.S.C. Chapter 5) requirements.
Under FFDCA, EPA has discretionary authority to establish, modify, or revoke a tolerance or exemption from a tolerance. Further, any person may petition EPA to take such actions. FFDCA specifies the types of information required in a petition and requires EPA, upon considering the submitted information and other available information, to either (1) establish, modify, or revoke tolerances or exemptions from tolerances or (2) deny the petition.
EPA relies on risk assessment guidance and principles to reach decisions on tolerances or tolerance exemptions. The agency's risk assessment process involves characterizing potential risks from likely exposures to a pesticide. For example, EPA would examine the following factors to characterize potential risks:
In particular instances and depending on the information, EPA may apply uncertainty factors that would result in more stringent standards than would otherwise be required. With regard to outstanding scientific and technical matters, EPA may consult with independent advisory committees (e.g., FIFRA Scientific Advisory Panel, FQPA Science Review Board) to solicit professional and expert input on risk assessment processes, specific pesticide issues, or other related topics.
Though EPA is responsible for establishing tolerances or tolerance exemptions, the U.S. Department of Agriculture and the Food and Drug Administration monitor pesticide residues in foods and may seize food that exceeds pesticide tolerances. EPA may use monitoring data from these two agencies to help inform decisions on tolerances and tolerance exemptions.
In 1996, FQPA amended FFDCA to require EPA to review all existing tolerances (9,721) within 10 years of enactment to determine if they met the revised statutory standard. This "tolerance reassessment" occurred in conjunction with a separate one-time review of registrations of all pesticide active ingredients issued before 1984. The statute allowed existing tolerances to remain in effect until EPA completed the reassessment. EPA completed tolerance reassessment in 2007 (73 Federal Register 51472). Many existing tolerances were retained, some revised, and others revoked based on the agency's determinations.
FIFRA also requires EPA to review at least once every 15 years all pesticide registrations, including tolerances, to ensure that they continue to meet statutory standards. EPA began the current round of pesticide registration reviews in 2007 and is statutorily required to complete the review by October 1, 2022. As part of the review, EPA completes risk assessments to determine whether the registration and associated tolerances continue to meet the statutory standard. If EPA finds that tolerances do not meet the statutory standard based on new information, the agency must modify or revoke them. Existing tolerances remain in effect until they are found to require revision. EPA pesticide registration review activities are ongoing.
FFDCA provides for administrative and judicial review of certain EPA decisions on tolerances and tolerance exemptions to give interested persons the opportunity to present their objections to agency decisions and ensure that tolerances and tolerance exemptions meet the statutory criteria. For example, any person may file an objection to an EPA decision on a tolerance petition within 60 days of its issuance and may also request a hearing. Additionally, various EPA final actions pertaining to tolerance setting are judicially reviewable in the United States Courts of Appeals. For example, an EPA order ruling on objections to establishment, modification, or revocation of a tolerance or exemption from a tolerance may be judicially reviewed. Ultimately, EPA's capacity to establish tolerances and tolerance exemptions depends on resources and scientific and technical judgment of complex information.
Chlorpyrifos is an insecticide that has been registered in the United States since 1965 and is currently registered for agricultural and other limited uses. In 2006, as part of tolerance reassessment, EPA completed its review of chlorpyrifos tolerances, and various tolerances were retained, lowered, or revoked in accordance with the assessment. Then in 2007, certain environmental organizations petitioned EPA requesting that the agency revoke all tolerances for chlorpyrifos and cancel all agricultural uses of the insecticide. Petitioners later filed a lawsuit to compel a complete response to the petition. In October 2015, EPA proposed to revoke all chlorpyrifos tolerances in response to the litgation (80 Federal Register 69079). In April 2017, however, EPA issued an order to deny the 2007 petition, stating that the petitioners had not provided sufficient evidence that chorpyrifos tolerances did not meet the statutory standard and the agency will continue to examine chlorpyrifos tolerances as part of registration review to be completed by 2022 (82 Federal Register 16581). EPA will accept requests for hearings and objections through June 5, 2017, and litigation is ongoing.