Revoking Pesticide Tolerances

EPA sets the tolerance for each pesticide that may be found on foods. When circumstances require, we can revoke tolerances to better safeguard public health and the environment. We 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.
• The tolerances do not meet the statutory safety standard.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), we must modify or revoke any tolerance we determine is unsafe. When a use of a pesticide on food is found to be unsafe, we act 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 pesticide tolerance, which was set under FFDCA.

Unless risk concerns dictate otherwise, we generally move to restrict or forbid sale, distribution, and use of a pesticide under FIFRA before modifying or revoking tolerances.

EPA can cancel a pesticide registration in whole or in part. In some cases, there are risk concerns driving the cancellation. In addition, we 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:

• in the case of risk-related cancellations, all registrations of the pesticide have been canceled or modified; or
• 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 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

1. We publish a proposal to revoke the tolerance in the Federal Register explaining the basis for the decision.
2. We provide a public comment period, during which any party may submit comments.
   • We typically provide a 60-day comment period. We 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.
3. If, following public comment, we decide to revoke the tolerance, a final regulation revoking the tolerance is published in the Federal Register.
   • Interested parties, including members of the public, have 60 days to provide objections and to request a hearing.
     • Interested parties must submit an objection during this 60-day period if they wish to seek judicial review of the tolerance revocation.
     • We hold a public evidentiary hearing if necessary to address material issues of fact raised by the objections. We will not hold a hearing on purely legal issues.
     • If objections are received, we 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). 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.
4. Tolerance revocations are generally effective upon publication of the final regulation, although a revocation rule may specify a different effective date. We are also authorized to stay the effective date if objections are filed.