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Explanation of Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides

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The following information explains how EPA currently is addressing under FIFRA the risks and benefits of pesticides that may have public health uses.

The Agency's current policy and practice is to consider the risks and benefits of any pesticide use (including pesticides with public health uses) separate from other uses and to the extent needed for making a regulatory decision. If there are no risk concerns for a particular pesticide use, that use usually will be determined eligible for registration or reregistration without any formal consideration of benefits. However, where a particular use presents significant risk concerns, the Agency then considers how the potential benefits, including those benefits derived from disease control or prevention in the case of a public health pesticide, weigh against the potential risks of that use. Under existing law, EPA considers and will continue to consider the risks and benefits of each use, including public health uses, regardless of whether the pesticides are "public health pesticides" as defined in FIFRA section 2(nn)

Key points in EPA's current practice include:

  1. The term "public health pesticide" is narrowly defined in FIFRA section 2(nn), but that definition does not encompass all the pesticides that have important public health uses. We believe that in section 2(nn) Congress merely intended to identify a particular set of pesticides used for public health purposes that are to receive special treatment under section 4. EPA considers, and will continue to consider, in its risk/benefit decisions the public health benefits of any pesticide, regardless of whether the pesticide is a minor use pesticide or whether it is registered for use and used predominately in public health programs or for other recognized health protection uses.

  2. Before suspension, cancellation, or denial of an application for registration or a determination of ineligibility for reregistration of a public health use of any pesticide for reasons of unreasonable risk, the Agency will consult with other Federal agencies, such as the Centers for Disease Control and Prevention, to better understand the public health benefits of that pesticide. Such consultation is required in certain circumstances (see e.g., FIFRA section 6(b)(2)) and otherwise within the scope of the Agency's discretionary authority (see e.g., FIFRA section 3(f)(3)).

  3. FIFRA section 2(bb) defines "unreasonable adverse effects on the environment" to mean, in part, "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide...." The Agency interprets this broad statutory language to mean that any significant benefits to public health through disease control or prevention, or through vector control, need to be considered in the suspension, cancellation, or denial of an application for registration or a determination of ineligibility for reregistration of a public health use of any pesticide that offers such benefits.

  4. The Agency's benefits assessment of pesticides that control disease vectors reflect, and will continue to reflect, the available information on the benefits derived from prevention or control of disease.

In summary, the Agency's assessment of public health uses of pesticides always have and will continue to consider the public health benefits when risks are of concern for a particular use. The assessment of benefits will include the benefits that are gained from use of the pesticide in controlling public health pests and the diseases which they may transmit. We believe these actions ensure that public health benefits are carefully considered in both registration and reregistration decisions.

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