United States
                       Environmental Protection
Prevention, Pesticides
and Toxic Substances
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
              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
                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.

       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
       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.