United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-01-001
January 2001
SERA Phosalone Facts
EPA has assessed the dietary risks of phosalone and prepared a "Report on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decision" for this organophosphate (OP)
pesticide. Phosalone fits into its own "risk cup"-- its individual risks are within acceptable levels.
Phosalone has no U.S. registrations and nine
import tolerances, on almond (hulls), almonds, apples,
apricots, cherries, grapes, peaches, pears, and plums
(fresh prunes). Phosalone treated crops do not pose
risk concerns, and no risk mitigation is necessary at
this time.
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 phosalone cannot be considered final until this
cumulative assessment is complete. Further risk
mitigation may be warranted 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 phosalone 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 decisions presented in this interim decision document, which concludes the OP pilot process for
phosalone.
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.
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Uses
An insecticide/acaricide, phosalone is used to control various insect species in/on almonds,
apples, apricots, cherries, grapes, peaches, pears, and plums in Algeria, Austria, Belgium,
Canada, Croatia, Czech Republic, France, Greece, Hungary, Iraq, Italy, Japan, Kuwait,
Morocco, Poland, Portugal, Russia, Slovak Republic, Spain, Switzerland, Taiwan, Tunisia,
Turkey, and Ukraine. It is not registered under FIFRA and may not be sold, distributed, or
used in the U.S.
Nine import tolerances are established for residues of phosaone in/on imported almonds,
apples, apricots, cherries, grapes, peaches, pears, and plums. It is estimated that less than
1.5% of the apples (fresh and dried), 0.1% of pears, 0.05% of peaches, and 0.2% of plums
available in the U.S. are imported from countries with phosalone registrations. Total imports
treated with phosalone is approximately 13.0 %; 6.0 % of which is from apple juice.
Health Effects
Risks
Phosalone 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 eating food crops treated with phosalone are below the level of
concern for the entire U.S. population, including infants and children. Dietary exposure through
drinking water is not expected because there is no domestic usage.
Risk Mitigation
Dietary risk from exposure to phosalone does not exceed EPA's level of concern. Therefore,
no mitigation is necessary and no further actions are warranted at this time.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The phosalone IRED therefore is issued in final (see wwvj^a.govMEDs/ or
www.epa. ci ), 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 phosalone and may request further risk
mitigation measures. For all OPs, raising and/or establishing tolerances will be considered once
a cumulative assessment is completed.
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