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