In a 2018 report, the EPA’s Office of Inspector General (OIG) said it found flaws in how the Agency’s Office of Pesticide Programs (OPP) managed the pesticide emergency exemption process authorized by Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, the OIG said the OPP does not use emergency exemption data to measure how effectively the emergency exemption process maintains human health and environmental standards.
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Accordingly, the OIG recommended that the OPP develop and implement outcome-based performance measures to demonstrate the human health and environmental effects of emergency exemption decisions. The Office of Chemical Safety and Pollution Prevention (OCSPP), the OPP’s parent office, disagreed with the recommendation, stating that such measures are neither appropriate nor feasible and that the EPA’s current process adequately meets the Agency’s statutory obligations.
Exemptions and Durations
Section 18 allows the EPA to grant federal and state agencies four types of emergency exemptions to control unexpected pests, invasive species, or other pests that cannot be controlled with registered pesticide products. The exemptions apply in different circumstances and have different durations. For example, a quarantine exemption controls invasive species and has a maximum 3-year duration. A crisis exemption has a maximum 15-day duration.
Application
To obtain an emergency exemption, a state lead agency (SLA) submits an application to the EPA. The application specifies the estimated significant economic loss without the expanded use, the total requested application acreage, the requested application rate and other parameters of use, and other information.
In most instances, the applicant requests approval for the expanded use of a pesticide that has already been registered by the EPA for other uses. Because of the existing registration, the review time for the short-term emergency use is significantly reduced compared to the full FIFRA registration process. The OPP tries to review and approve most emergency exemption applications (other than crisis types) within 50 calendar days of receipt. As long as the situation meets the emergency exemption criteria, SLAs may reapply for a repeat exemption. However, if there is a continuing need for a pesticide for an unregistered use, the EPA expects the manufacturer to move to obtain registration for that use; absent such an effort, the Agency may refuse to grant the emergency exemption.
Measuring Outcome
The OIG reported that the OPP uses emergency exemption applications to collect data on the applicant, site, pest, chemical, received date, response date, expiration date, and status. Applicants are also required to report to the OPP on certain outcomes such as the number of acres to which the exempted pesticide was applied.
But the OIG reports that the OPP does not use these data to measure the impacts or potential risks of the pesticides it exempts. According to the OIG, as of March 2018, the only official measure for the emergency exemption process was the average number of days to review applications. The OIG states:
“The OPP should use its data to measure outputs and outcomes to determine whether its decisions are protective of human health and the environment. In discussing program outcomes, OPP staff indicated that one factor that suggests that the emergency exemption program has been successful is a decrease in the number of emergency exemption applications over the years. However, the decline in the number of applications does not measure whether there were reductions in risks or increases in benefits to human health or the environment. Without meaningful outcome-based measures in place, the OPP does not know whether a decline in applications also resulted in changes to human health and environmental impacts.”
Obligations Adequately Met
According to the OCSPP, the OPP processes emergency exemption applications in full accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. The OCSPP states:
“OPP assesses all emergency exemptions for human and environmental safeguards consistent with these statutory requirements. In addition, each emergency exemption decision details the conclusions of OPP’s assessment and the public safety requirements necessary to support the approved use. As a result, the decision to authorize an emergency exemption under FIFRA Section 18 ensures that the pesticide can be used safely, in accordance with federal law. The human health and environmental risk assessments done for all Section 18 exemptions are based on the best available data and assessment procedures, and must ensure the same safety findings are made as for uses covered by Section 3 registrations. As such, OPP believes that emergency exemption decisions, which are scientifically supported by risk assessments, show that EPA has adequately met its obligations under our regulatory statutes.”
The EPA added that it had no plans to implement the OIG’s recommendation regarding outcome-based performance measures.
The OIG’s report is here.