United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-00-010
October 2000
Fenitrothion Facts
EPA has assessed the risks of fenitrothion and completed a "Report on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decision for Fenitrothion" for this
organophosphate (OP) pesticide. Without risk mitigation, fenitrothion fits into its own "risk cup"-- its
individual, aggregate risks are within acceptable levels. Fenitrothion also is eligible for reregistration,
pending a full reassessment of the cumulative risk from all OPs.
In July 1995 a RED was issued for
fenitrothion. Most uses were canceled during the
RED process or subsequent to the issuance of the
RED. Currently used in Australia on stored wheat
and in the U.S. in containerized ant and roach baits in
child resistant packaging, fenitrothion residues in
food do not pose risk concerns and exposure
resulting from use of the containerized ant and roach
baits is expected to be insignificant. Without
mitigation fenitrothion fits into its own "risk cup."
EPA's next step under the Food Quality
Protection Act (FQPA) is to complete a cumulative
risk assessment and risk management decision
encompassing all the OP pesticides, which share a
common mechanism of toxicity. The interim
decision on fenitrothion cannot be considered final
until this cumulative assessment is complete. Further
risk mitigation may be required at that time.
EPA is reviewing the OP pesticides to
determine whether they meet current health and
safety standards. Older OPs need decisions about
their eligibility for reregistration under FIFRA. OPs
with residues in food, drinking water, and other non-
occupational exposures also must be reassessed to
make sure they meet the new FQPA safety standard.
The fenitrothion interim decision was made through the OP pilot public participation process,
which increases transparency and maximizes stakeholder involvement in EPA's development of risk
assessments and risk management decisions. EPA worked extensively with affected parties to reach
The OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality
Protection Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
-------
the decisions presented in this interim decision document, which concludes the OP pilot process for
fenitrothion.
Uses
An insecticide/acaricide, fenitrothion is used in Australia on stored wheat and there is a U.S.
tolerance for imported wheat gluten. The only registered use in the U.S. is for containerized
ant and roach baits in child resistant packaging.
Annual domestic use is low. Annual U.S. consumption of wheat gluten by the food industry is
about 250 million pounds; currently approximately 26% (65 million pounds) is imported from
Australia. No data are available on percent crop treated in Australia.
Health Effects
Risks
Fenitrothion can cause cholinesterase inhibition in humans; that is, it can overstimulate the
nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
accidents or major spills), respiratory paralysis and death.
Dietary exposures from consuming wheat gluten treated with fenitrothion are below the level
of concern for the entire U.S. population, including infants and children. Drinking water is not
a source of exposure.
Risks are not of concern for the use of fenitrothion in containerized ant and roach baits in child
resistant packaging. Exposure is expected to be insignificant because the material is not
available through the dermal and oral routes; and, due to the small amount of material which
would be available through volatilization, inhalation exposure is expected to be minimal.
Risk Mitigation
• No risk mitigation is necessary at this time.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The fenitrothion IRED therefore is issued as final (see
www.epa.gov/pesticides/opl without a formal public comment period. The docket remains
open, however, and any comments submitted in the future will be placed in this public docket.
-------
When the cumulative risk assessment for all organophosphate pesticides is completed, EPA
will issue its final tolerance reassessment decision for fenitrothion and may require further risk
mitigation measures. The Agency will amend the only tolerance for fenitrothion now. The
tolerance for wheat gluten imported from Australia will be lowered to 3 ppm and the tolerance
expression will be modified to include only the parent compound. For all OPs, raising and/or
establishing tolerances will be considered once a cumulative assessment is completed.
------- |