Pesticide Cancellation Under EPA's Own Initiative
Section 6(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to take the initiative to cancel a pesticide registration when existing risks related to the use of the pesticide are unacceptable, and registrants either have not made, or cannot make, necessary changes to the terms and conditions of the registration to address the unacceptable risks.
Cancellation of a pesticide registration may be initiated by EPA after the Agency has evaluated the potential risks and benefits associated with registered uses of a pesticide.
- In order to initiate cancellation based on dietary risks, EPA must determine that the risks exceed the "reasonable certainty of no harm" standard applicable to pesticide residues in food under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
- In order to initiate cancellation based on other risks (such as residential, occupational or ecological risks), EPA must determine that the risks are unreasonable in light of the benefits associated with the pesticide use.
Although not required to do so by statute, EPA typically solicits input from stakeholders and the public relating to risks, benefits, and possible risk-mitigation options before initiating cancellation action.
The Agency will initiate cancellation action if it determines that dietary (food and drinking water) and/or non-dietary (residential, occupational and ecological) risks of concern necessitate the cancellation of all currently registered uses of a pesticide, or such risks necessitate changes to the terms and conditions of registration that registrants have been unwilling to implement.
Procedures for Non-voluntary Cancellation
- Notice of Intent to Cancel
- USDA and FIFRA SAP Notification
- NOIC Issuance
- Hearing Process
- Appeal and Judicial Review of Decision
When the Agency decides to cancel registration of a pesticide product, it prepares a Notice of Intent to Cancel (NOIC) that is published in the Federal Register and sent to registrants. Before EPA may formally issue a NOIC, it typically must provide notice of the proposed cancellation first to the Department of Agriculture and to a scientific advisory board.
At least 60 days before providing a NOIC to the registrant and the notice to the public, EPA must notify and provide the Secretary of Agriculture with a draft copy of the NOIC and an analysis of the impact of cancellation on the agricultural community.
- The Secretary of Agriculture has 30 days to comment.
- If the Secretary provides comment, EPA must publish the comments and EPA's response to the comments in the Federal Register along with the NOIC.
- If the Secretary does not comment, EPA may proceed with the NOIC immediately.
- The EPA Administrator and the Secretary of Agriculture may waive or modify these dates.
Concurrent with the notification of the Secretary of Agriculture, EPA must also submit the NOIC to the FIFRA Scientific Advisory Panel (SAP) for comment on the effect of the NOIC on health and the environment.
- This requirement may only be waived or modified with the SAP's consent.
- If the SAP meets, it will hold a public meeting, at which time the public will have an opportunity to participate.
After complying with the steps above, the EPA Administrator may issue a NOIC together with the reasons (including the factual basis) for the action.
- The notice is sent to the registrant and published in the Federal Register.
- The NOIC must consider the effect of cancellation on production, price of agricultural commodities, retail food prices, and the agricultural economy as a whole.
The cancellation outlined in the NOIC becomes final and effective 30 days after the registrant receives the notice, or when the notice is published in the Federal Register (whichever occurs later) unless within that time, a request for a hearing is made by a person adversely affected by the notice. This time period is statutory and cannot be extended.
While anybody can request a hearing, a hearing cannot proceed without the acquiescence of a registrant. In other words, if no registrant is interested in retaining a registration, and no other person wishes to become a registrant, a hearing is not convened.
During the time period pending a hearing, the registrations remain active unless EPA initiates suspension action under FIFRA section 6(c).
If a hearing is held, it will be held in accordance with FIFRA section 6(d) and 40 C.F.R. Part 164. The hearing is chaired by an administrative law judge who makes procedural and substantive decisions. The burden of proof is on the proponents of registration of the pesticide.
Any interested person or entity (e.g., grower, manufacturer, environmental or other public interest groups, etc.) can participate in the hearing as intervenors, making them full participants in all phases of the hearing. Parties who elect not to intervene (or request a hearing) have only limited rights in a hearing. Such non-participants may be able to file amicus briefs (as an interested party) at the end of the hearing, but they cannot provide new factual information for inclusion in the hearing record, nor can they cross-examine other witnesses. The hearing decision must be based on the hearing record, which consists of cross-examination of witnesses and documents and testimony introduced by parties to the proceeding.
The hearing is an administrative trial with typically an exchange of documents and witness lists. Parties generally file written testimony from witnesses, who are then cross-examined by other parties. The administrative law judge then makes an initial decision based upon the record.
The administrative law judge's decision can be appealed to the Environmental Appeals Board (EAB), which, on behalf of the Administrator, issues the final decision for the Agency.
In making a cancellation decision, the Administrator is required by FIFRA to consider restricting the use of the pesticide as an alternative to cancellation while explaining the reasons for the restrictions and taking into account the effect of such final action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy. This analysis must be published in the Federal Register.
A final cancellation order following a public hearing is subject to judicial review within 60 days after entry of the order. Judicial review-where the court makes sure that the law has been properly applied-is available only to those adversely affected by the order and who participated as a party in the hearing. Because the Administrator (or the EAB acting for the Administrator) issues the final decision for the Agency, the prosecuting arm of the Agency cannot discuss the case with the Administrator while the case is pending and cannot appeal an adverse decision from the Administrator.