EPA Announces It Is Unlikely to Approve New Outdoor Neonicotinoid Pesticide Uses
As part of EPA’s ongoing effort to protect pollinators, the Agency has sent letters to registrants of neonicotinoid pesticides with outdoor uses informing them that EPA will likely not be in a position to approve most applications for new uses of these chemicals until new bee data have been submitted and pollinator risk assessments are complete. The letters reiterate that the EPA has required new bee safety studies for its ongoing registration review process for the neonicotinoid pesticides, and that the Agency must complete its new pollinator risk assessments, which are based, in part, on the new data, before it will likely be able to make regulatory decisions on imidacloprid, clothianidin, thiamethoxam, and dinotefuran that would expand the current uses of these pesticides. Affected neonicotinoid actions include:
- New Uses (including crop group expansion requests)
- Addition of New Use Patterns, such as aerial application
- Experimental Use Permits
- New Special Local Needs Registrations
This is an interim position. However, if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA is prepared to consider whether an emergency use under FIFRA section 18 might be appropriate. Due to the localized nature of many emergency pest management programs, it may be possible to develop mitigation or adjust the use pattern in a manner that would minimize exposure to bees. In the event that an emergency use is requested, the Agency plans to assess such requests by relying on available information and risk mitigation strategies.
More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection
How EPA Assesses Risks to Pollinators
- Pollinator Risk Assessment Guidance
- FIFRA Peer Review: Proposed Risk Assessment Process
- Global SETAC Workshop
EPA has improved how it evaluates the risks to bees resulting from the use of pesticides. This Web page provides an overview of the process.
On this page:
- Overview of EPA’s pesticide risk assessment process for bees
- Data for informing EPA’s pesticide risk assessment process for bees
- More information
Overview of EPA’s Pesticide Risk Assessment Process for Bees
Historically, EPA’s pesticide risk assessment process for bees has been qualitative (i.e., not measured). The process relied primarily on developing an understanding of the types of effects that might be caused by the pesticide (hazard characterization), based on toxicity studies.
In 2011, EPA began expanding the risk assessment process for bees to quantify or measure exposures and relate them to effects at the individual and colony level. This involved identifying additional data that would be needed to inform that process. These data are summarized in the table below.
In November, 2012, EPA, in collaboration with Health Canada’s Pest Management Regulatory Agency and the California Department of Pesticide Regulation, presented a quantitative risk assessment process for bees and other insect pollinators to the FIFRA Scientific Advisory Panel.
EPA has begun to employ its new risk assessment framework for bees as part of its regulatory decision-making process for all pesticide chemistries. The new framework:
- Relies on a tiered process.
- The lowest tier (Tier I) is intended to serve as a screening tool. It employs conservative assumptions regarding exposure (i.e., assumptions that are likely to overestimate exposure) and uses the most sensitive toxicity estimates from laboratory studies of individual bees to calculate risk estimates.
- Higher tiers (Tiers II and III) rely on characterization of risk based on measured exposure values and colony-level effects studies and so are more realistic.
- Focuses on the major routes of exposure, including contact exposure (e.g., from overspray or direct contact with the pesticide on the plant surface) and dietary exposure (e.g., from consumption of contaminated pollen or nectar).
- Distinguishes different types of pesticide treatments, such as compounds applied to plant leaves or seed/soil-applied (systemic) compounds.
Initial Assessment (Tier I)
The new process begins as a screen, i.e., Tier I, which is designed to quickly determine which pesticides are expected to pose minimal risk, indicating pesticides for which further risk analysis is not needed. Tier I risk assessments are designed to be conservative, relying upon high-end estimates of exposure and laboratory-based toxicity data from studies conducted with individual bees.
If we identify a potential risk of concern at the Tier I level, EPA and/or the pesticide registrant can propose information with which to refine exposure estimates. Additional information that can be used to refine a Tier I risk estimate includes information on the intended use of the product or possible mitigation options. With this additional information and/or data, risk estimates may be revised.
More Refined Assessments (Tier II and Tier III)
For compounds where potential risks of concern persist, higher tier assessments may be conducted:
- Tier II (semi-field studies) and
- Tier III (full-field studies).When graduating to a higher tier analysis, EPA may require studies designed to more closely reflect real world exposures and effects on the whole colony. Tier II data may include:
- Feeding studies, which examine effects on colonies following exposures to known concentrations of a pesticide in a food source fed to a bee colony.
- Semi-field studies,which examine effects on colonies contained within enclosures.
- Residue studies intended to quantify pesticide concentrations in pollen and nectar of crops treated according to the labels.
Tier II studies can be used to characterize risk at the colony level. Because the information at this level, i.e., both exposure and effects information, is more specific to the actual use of the pesticide under review, it can also be used to identify risk mitigation options. EPA can then begin to determine whether sufficient information is available to support the regulatory decision process or whether additional information is needed to understand the potential risk.
If refined exposure and/or effect data or risk mitigation options at the Tier II level do not indicate acceptable risk or substantial uncertainties remain, then EPA may require a Tier III evaluation to resolve uncertainties. A Tier III assessment may include a full-field (free-foraging bees) study. A Tier III assessment is intended to:
- address specific questions regarding the potential effects of the pesticide compound at the colony level where the compound is applied in accordance with label conditions;
- take into account the broad dynamics of a whole colony in an free-foraging scenario; and,
- consider long-term effects on the colony, such as over-wintering success.
Information from Tier III is intended to be used with the information gathered through Tier I and Tier II, as well as other lines of evidence available to the Agency (e.g., bee kill incident information or open literature studies that meet EPA guidelines). With the information from all the studies in hand, EPA can determine whether mitigation options exist protect bees from pesticide exposure.