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Clothianidin – Registration Status and Related Information

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Current as of July 27, 2012

This page contains information describing the registration status of clothianidin, a neonicotinoid pesticide.

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Basic Information

The EPA originally evaluated clothianidin for registration through a North American Free Trade Agreement Joint Review (PDF) (18 pp, 120 k, about PDF) with Canada in 2003. During that process, we identified it as an alternative to organophosphate and carbamate pesticides. Both of these classes of older insecticides are very highly acutely toxic to bees and, unlike clothianidin, are also very highly acutely toxic to humans and wildlife. When the EPA granted the initial registration for clothianidin seed treatment uses in 2003, the agency determined that the uses met the risk/benefit and safety standards for registration as required by federal law.

International Registrations

Many countries have registered clothianidin for both foliar use and as a seed treatment. Canadian and U.S. seed treatment uses were registered concurrently. Clothianidin is also registered as a seed treatment in the following European countries: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain and the UK.

Risk Assessment and Risk Mitigation

We base pesticide risk characterizations on the entire body of data for any given pesticide. For clothianidin, we based the weight-of-evidence risk characterization on more than 100 studies, including EPA’s review of studies the registrant submitted to support the clothianidin registration.

Clothianidin generally poses less risk to agricultural workers and fish and wildlife when compared to the organophosphate and carbamate insecticide alternatives. The short-term exposure data show that clothianidin is toxic to   bees, as are most insecticides. Current labels for clothianidin products used as foliar treatments (e.g. spray applications) include bee hazard statements (PDF) (16 pp, 825 k, about PDF) that prohibit use when plants are flowering and bees are in the area. The EPA is not aware of any data demonstrating that bee colonies are subject to elevated losses due to long-term exposure to this compound.

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Responses to Petitions

2012
A group of beekeepers and honey producers, Beyond Pesticides, Center for Food Safety, International Center for Technology Assessment, and Pesticide Action Network of North America sent the agency a petition seeking emergency suspension of clothianidin in March 2012. The EPA responded to the imminent hazard portion of the petition in July 2012. The agency concluded the petition does not demonstrate that clothianidin poses an imminent hazard to bees and denied the request for immediate suspension of the use of clothianidin. The docket for the 2012 petition is available under docket ID EPA-HQ-OPP-2012-0334 at regulations.gov. The agency published the full petition for a 60-day public comment period in a July 27, 2012, Federal Register notice.

EPA's Response to the 2012 Petition (PDF) (12 pp, 5 MB, about PDF)

2010
 A different group sent a letter urging the EPA to issue a “stop use order” on clothianidin (PDF) (6 pp, 529 k, about PDF) to address the situation in December 2010. The EPA responded to the request to ban clothianidin in February 2011 (PDF) (4 pp, 1 MB, about PDF). Our response describes the legal requirements that must be satisfied to declare an imminent hazard and to issue a stop use order, neither of which are satisfied by data currently available to the agency.

Next Regulatory Steps for Clothianidin

Given the concern about clothianidin and other neonicotinoid pesticides and the EPA’s dedication to pollinator protection, the agency has accelerated the comprehensive re-evaluation of these pesticides in the registration review program. We are coordinating this re-evaluation with California’s Department of Pesticide Regulation and Canada’s Pest Management Regulatory Authority. This extensive review will determine if any restrictions are necessary to protect people, the environment, or pollinators. The EPA’s registration review docket for clothianidin opened in December 2011 (Docket ID: EPA EPA-HQ-OPP-2011-0865). In September 2012, the agency will seek independent scientific peer review on how to better assess the risks of pesticides to pollinators. This effort will improve our understanding and strengthen the scientific and regulatory process to protect honey bees and other pollinators.

Regulatory actions for clothianidin under registration review

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2010 Reclassification of Clothianidin Field Study for Pollinators

Though the registrant satisfied the basic study requirements for registration in 2003, we required an additional field study to address uncertainties about potential long-term effects of clothianidin on honey bees. In 2007, we reviewed this study and determined that it satisfied the EPA’s field study guidelines. However, the agency’s assessment of the usefulness of this study has changed since the initial 2007 review, which is not unusual in the scientific field.

As the EPA’s understanding of honey bee biology has improved, staff scientists have started to recognize the challenges associated with field pollinator study designs. While elaborate field studies can be designed, there may be confounding effects that limit the utility of a study but may not entirely discredit it.

It is clear that field pollinator studies cannot be viewed in the same context as laboratory studies where experimental conditions can be strictly manipulated. Recognizing the complexity of conducting field studies, the EPA is endeavoring to make the best use of existing data to address uncertainties. Although the EPA noted deficiencies in the clothianidin pollinator field study, including some cross contamination between treated and non-treated (control) experimental plots and inadequate separation between treated and control portions of the study, there was useful information that could be used to qualitatively describe hive survival following exposure to clothianidin.

The reevaluation of the study in question does not change the agency’s conclusion that the registered uses of clothianidin meet the FIFRA risk/benefit standard for registration.

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