Revoking Pesticide Tolerances
Under federal law, EPA is responsible for regulating the pesticides that are used by growers to protect crops and for setting limits on the amount of pesticides that may remain in or on foods marketed in the United States. In the U.S., we call these pesticide residue limits on foods "tolerances." In many other countries, they are called "maximum residue limits," or "MRLs."
EPA sets the tolerance for each pesticide that may be found on foods. The Food and Drug Administration (FDA) monitors compliance with tolerances established for most foods except meat, poultry, and some egg products, which are monitored by the Department of Agriculture (USDA). This Web page explains the regulatory issues and procedures for revoking a tolerance.
However, when circumstances require, EPA can also revoke tolerances to better safeguard public health and the environment. EPA may revoke pesticide tolerances for any of these reasons:
- All registrations of a pesticide have been canceled in the United States and the tolerances are not needed for imported foods;
- There are no registered uses for certain crops;
- EPA determines that tolerances are not needed;
- EPA conducted cancellation proceedings due to unacceptable risks; or
- The tolerances do not meet the statutory safety standard.
Under the Federal Food, Drug, and Cosmetics Act (FFDCA), EPA must modify or revoke any tolerance it determines is unsafe. When a use of a pesticide on food is found to be unsafe, EPA acts to address this problem by both modifying or canceling the pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and modifying or revoking the associated FFDCA pesticide tolerance. Unless risk concerns dictate otherwise, EPA generally moves to restrict or forbid sale, distribution, and use of a pesticide under FIFRA prior to modifying or revoking FFDCA tolerances.
EPA can cancel a FIFRA registration in whole or in part. In some cases there are risk concerns driving the cancellation. In addition, EPA can cancel a pesticide registration for reasons unrelated to risk, such as nonpayment of maintenance fees. Registrants can voluntarily cancel pesticide registrations at any time. Tolerances would be revoked when (1) in the case of risk-related cancellations, all registrations of the pesticide have been canceled or modified, or (2) for non-risk related cancellations, no registrations remain for the canceled uses and the tolerances are not needed for imported foods.
Food products (commodities) lawfully treated under FIFRA before revocation of a tolerance are still considered to be covered by the tolerance if the residues are within the tolerance level. Because showing when a food was treated can be difficult, EPA generally considers how long it will take for treated commodities to pass through the channels of trade in determining when to make a tolerance revocation effective. If there are reasons to revoke a tolerance before all commodities treated while the tolerance was in effect have cleared the channels of trade, EPA works with FDA or USDA to develop guidance for food processors on how to document that food products were legally treated. If even legally treated commodities pose an unreasonable risk, EPA can make a revocation effective without allowing for commodities to clear channels of trade.
Procedural Steps for Revoking Tolerances
- EPA publishes a proposal to revoke the tolerance in the Federal Register that explains the basis for EPA's decision.
- EPA provides a public comment period, during which any party may submit comments.
- EPA typically provides a 60-day comment period. EPA may shorten the comment period for good cause and provide an explanation for the shorter period in the Federal Register notice.
- To avoid any question as to whether they have waived the right to raise objections, interested parties must submit any comments during the comment period.
- Interested parties must submit an objection during this 60-day period if they wish to seek judicial review of EPA's tolerance revocation.
- EPA holds a public evidentiary hearing if necessary to address material issues of fact raised by the objections. EPA will not hold a hearing on purely legal issues.
- If objections are received, EPA must issue a final decision that responds to each objection. The decision on objections for which no hearing is requested, or for which a requested hearing is denied, is made by EPA's Office of Chemical Safety and Pollution Prevention (OCSPP); and this decision becomes the final determination on the tolerance.
- If a hearing is held on the objections, an administrative law judge must issue an initial decision, which sets forth in detail the findings of fact and conclusions of law. The administrative law judge's decision may be appealed to the Environmental Appeals Board (EAB) or Administrator. The EAB's (or Administrator's) decision becomes the final determination on the tolerance. If a hearing is requested and granted, the Administrator becomes the ultimate decision-maker for the Agency on the issues in the hearing, and OCSPP must not communicate with the Administrator on the substantive issues involved until the final decision is issued.
- Any person or entity (other than EPA) adversely affected by the final decision on objections to a final rule revoking a tolerance may seek judicial review in the U.S. Court of Appeals, within 60 days from the publication of the final decision.