United States Prevention, Pesticides EPA 738-R-01-001

Environmental Protection And Toxic Substances January 2001

Agency (7508C)

Report on FQPA Tolerance

Reassessment Progress 

and Interim Risk 

Management Decision for

Phosalone

United States Prevention, Pesticides EPA 738-F-01-001

Environmental Protection and Toxic Substances January 2001

Agency (7508C)

 

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 nonoccupational 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.
2

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

• 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. 

Risks 

• 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 www.epa.gov/REDs/ or

www.epa.gov/pesticides/op ), 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. 
 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant:

This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or

the Agency) has completed its review of the available data and public comments received related to the

revised risk assessment for the organophosphate pesticide phosalone. The public comment period on

the revised risk assessment phase of the tolerance reassessment process is closed. The attached

document summarizes the Agency’s assessment of the dietary risk from phosalone as part of the

tolerance reassessment process for this chemical, presents a summary of the related food tolerance for

this single chemical, and provides the Agency’s current risk management decision based on the risk

assessment. Phosalone is not registered in the U.S. However, there are nine import tolerances. The

dietary risk analysis indicates that the risk is below the Agency’s level of concern. Therefore, no

mitigation is necessary at this time.

A Notice of Availability for this “Report on FQPA Tolerance Reassessment Progress

and Interim Risk Management Decision for phosalone” is published in the Federal Register. This

document and the technical documents supporting it are available for viewing in the Office of Pesticide

Programs' Public Docket and can also be found on the Agency’s web page,

"www.epa.gov/pesticides/op/phosalone.htm."

This document is based on the updated technical information found in the phosalone public

docket. The docket not only includes background information and comments on the Agency’s

preliminary risk assessments, but also now includes the revised risk assessment for phosalone, and a

document summarizing the Agency’s Response to Comments. The Response to Comments document

addresses corrections to the preliminary risk assessment submitted by the chemical manufacturer,

Aventis CropScience, as well as comments submitted by the general public and stakeholders during the

comment period on the risk assessment.

This document and the process used to develop it are the results of a pilot process to facilitate

greater public involvement and participation in the reregistration and /or FQPA tolerance reassessment

decisions on pesticides. As part of the Agency’s effort to involve the public in the implementation of the

Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain
open public dockets on the organophosphate pesticides and to engage the public in the reregistration

and tolerance reassessment processes for these chemicals. The idea of using such an open process

was developed by the Tolerance Reassessment Advisory Committee (TRAC), a large multistakeholder advisory body which advised the Agency on implementing the new provisions of the

FQPA. The reregistration and tolerance reassessment reviews for the organophosphate pesticides are

following this new process. 

Please note that the phosalone risk assessment concerns only this particular organophosphate. 

Because the FQPA directs the Agency to consider available information on cumulative risk from

substances sharing a common mechanism of toxicity, such as the toxicity expressed by the

organophosphates through a common biochemical interaction with cholinesterase, the Agency will

evaluate the cumulative risk posed by the entire organophosphate class of chemicals after completing

risk assessments for the individual organophosphates. The Agency is working to complete a

methodology to assess cumulative risk, and individual assessments of each organophosphate are likely

to be necessary elements of any cumulative assessment. The Agency has decided to move forward

with individual assessments and to identify mitigation measures where necessary. The Agency will issue

the final tolerance reassessment decision for phosalone once the cumulative assessment for all of the

organophosphates is complete.

If you have questions on this document, please contact the Special Review and Reregistration

Division representative, John Pates at (703) 308-8195.

Lois A. Rossi, Director

Special Review and 

 Reregistration Division

Attachment
Report on FQPA Tolerance Reassessment Progress

and Interim Risk Management Decision

for

Phosalone
TABLE OF CONTENTS

PHOSALONE TEAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

GLOSSARY OF TERMS AND ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v 

OVERALL RISK SUMMARY ................................................. v 

I. INTRODUCTION ...................................................... 1

II. CHEMICAL OVERVIEW ................................................ 2

A. Regulatory History ................................................ 2

B. Chemical Identification ............................................. 3

C. Use Profile ....................................................... 4

D. Estimated Usage of Pesticide ........................................ 5

III. SUMMARY OF PHOSLAONE RISK ASSESSMENT ......................... 8

A. Human Health Risk Assessment ..................................... 8

1. Dietary Risk from Food .......................................... 8

a. Toxicity ............................................. 8

b. FQPA Safety Factor ................................... 9

c. Population Adjusted Dose (PAD) ........................ 10

d. Exposure Assumptions ................................ 10

e. Acute Food Risk ..................................... 11

f. Chronic Food Risk ................................... 11

IV. FQPA TOLERANCE REASSESSMENT PROGRESS & INTERIM RISK

MANAGEMENT DECISION ............................................ 12

A. Tolerance Reassessment Progress & Interim Risk Management Decision . . 12

B. Summary of Phase 5 Comments ..................................... 13

C. Regulatory Position ............................................... 13

1. FQPA Assessment ............................................. 13

a. “Risk Cup” Determination ............................... 13

b. Tolerance Summary ...................................... 14

2. Endocrine Disruptors Effects .................................... 15

D. Regulatory Rationale ............................................. 16

V. WHAT MANUFACTURERS MUST DO ................................... 16

A. Additional Data Requirements ..................................... 16

B. Risk Mitigation Requirements ...................................... 17

VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM .................. 17

BIBLIOGRAPHY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
i

PHOSALONE TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

Kristina El-Attar

Bill Hazel

Kit Farwell

Use and Usage Analysis

Jihad Alsadek

Mike Hennessey

Registration Support

N/A

Risk Management

John Leahy

John Pates
GLOSSARY OF TERMS AND ABBREVIATIONS

ii

A E Acid Equivalent

a.i. Active Ingredient

AGDCI Agricultural Data Call-In

ai Active Ingredient

aPAD Acute Population Adjusted Dose

AR Anticipated Residue

ARC Anticipated Residue Contribution 

BCF Bioconcentration Factor 

CAS Chemical Abstracts Service

CI Cation

CNS Central Nervous System

cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula

CFR Code of Federal Regulations

CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In

DEEM Dietary Exposure Evaluation Model

DFR Dislodgeable Foliar Residue

DRES Dietary Risk Evaluation System

DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking

water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to

occur.

DWLOC Drinking Water Level of Comparison.

EC Emulsifiable Concentrate Formulation

EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,

such as a terrestrial ecosystem.

EP End-Use Product

EPA U.S. Environmental Protection Agency

FAO Food and Agriculture Organization

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

FQPA Food Quality Protection Act

FOB Functional Observation Battery

G Granular Formulation

GENEEC Tier I Surface Water Computer Model

GLC Gas Liquid Chromatography

GLN Guideline Number

GM Geometric Mean

GRAS Generally Recognized as Safe as Designated by FDA

HA Health Advisory (HA). The HA values are used as informal guidance to 

municipalities and other organizations when emergency spills or contamination situations occur.

HAFT Highest Average Field Trial

HDT Highest Dose Tested

IR Index Reservoir

LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be

expected to cause death in 50% of test animals. It is usually expressed as the weight of substance

per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.
GLOSSARY OF TERMS AND ABBREVIATIONS

iii

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in

50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is

expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LEL Lowest Effect Level

LOC Level of Concern

LOD Limit of Detection 

LOAEL Lowest Observed Adverse Effect Level

MATC Maximum Acceptable Toxicant Concentration

MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate

contaminants in drinking water under the Safe Drinking Water Act.

mg/kg/day Milligram Per Kilogram Per Day

mg/L Milligrams Per Liter

MOE Margin of Exposure 

MP Manufacturing-Use Product

MPI Maximum Permissible Intake

MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.

NA Not Applicable

N/A Not Applicable

NAWQA USGS National Water Quality Assessment

NOEC No Observable Effect Concentration

NOEL No Observed Effect Level

NOAEL No Observed Adverse Effect Level

NPDES National Pollutant Discharge Elimination System

NR Not Required

OP Organophosphate

OPP EPA Office of Pesticide Programs

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances

Pa Pascal, the pressure exerted by a force of one newton acting on an area of one square meter.

PAD Population Adjusted Dose

PADI Provisional Acceptable Daily Intake

PAG Pesticide Assessment Guideline

PAM Pesticide Analytical Method

PCA Percent Crop Area

PDP USDA Pesticide Data Program

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval

ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million

PRN Pesticide Registration Notice

PRZM/

EXAMS Tier II Surface Water Computer Model 

Q1* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model

RAC Raw Agriculture Commodity

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose
GLOSSARY OF TERMS AND ABBREVIATIONS

iv

RQ Risk Quotient

RS Registration Standard

RUP Restricted Use Pesticide

SAP Science Advisory Panel

SCI-GROW Tier I Ground Water Computer Model

SF Safety Factor

SLC Single Layer Clothing

SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)

TC Toxic Concentration. The concentration at which a substance produces a toxic effect. 

TD Toxic Dose. The dose at which a substance produces a toxic effect.

TEP Typical End-Use Product

TGAI Technical Grade Active Ingredient

TLC Thin Layer Chromatography

TMRC Theoretical Maximum Residue Contribution

torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.

TRR Total Radioactive Residue

UF Uncertainty Factor

μg/g Micrograms Per Gram

μg/L Micrograms Per Liter

USDA United States Department of Agriculture

USGS United States Geological Survey

UV Ultraviolet 

WHO World Health Organization

W P Wettable Powder

WPS Worker Protection Standard
v

Executive Summary

EPA has completed its review of public comments on the revised risk assessment and is issuing

its risk management decisions for phosalone, an organophosphate insecticide. The decisions outlined in

this document do not include the final decisions for phosalone. The revised risk assessment is based on

review of the required target data base supporting the nine phosalone import tolerances and information

received during the public comment periods in the open process developed through the Tolerance

Reassessment Advisory Committee (TRAC). 

Overall Risk Summary

All phosalone containing products registered in the U.S., as of 1992, have been canceled;

human exposure to this pesticide is strictly through the consumption of imported foods. This risk

assessment involves consideration of only the hazard component of the risk and food sources of dietary

exposure. Residential and occupational exposures as well as dietary exposure through drinking water

are not expected because there is no domestic use of phosalone. Therefore, aggregate acute and

chronic risks are attributable only to food sources of dietary exposure. EPA’s revised risk assessment

for phosalone indicates that acute and chronic dietary risk is below the Agency’s level of concern;

therefore, no risk mitigation is necessary at this time.

The tolerance reassessment decision for phosalone will be issued once the cumulative

assessment for all of the organophosphates is completed. The Agency may need to issue further risk

management measures for phosalone at the time the organophosphate cumulative assessment is

finalized. 
vi
1

I. Introduction

This report on the progress toward tolerance reassessment of phosalone is the result of the pilot

process developed through the TRAC to facilitate greater public involvement in the ongoing FIFRA

reregistration and FQPA tolerance reassessment initiatives on pesticides. Phosalone is subject only to

FQPA because it has only import tolerances and is not registered for use in the U.S. However, some

history and background of FIFRA is included here for informational purposes and to provide a

discussion of the existing laws governing pesticides.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. 

This Act amended FFDCA to require that all tolerances be reassessed within a 10-year period and that

those, which are considered to be the riskiest, are reassessed first and foremost. It also requires that by

August 2006, EPA review all tolerances in effect on the day before the date of the enactment of the

FQPA. Since organophosphates share a common mechanism of toxicity and are considered some of

the riskiest of all chemicals, it has been deemed necessary that these particular chemicals be grouped

together. The Agency will evaluate the cumulative risk posed by the entire organophosphate class of

chemicals after completing risk assessments for the individual organophosphates. Although not subject

to the reregistration process, due to no domestic registrations, phosalone does have import tolerances

that could factor into dietary risk. While the methodology for completion of the cumulative assessment

for all of the organophosphates is being developed, individual risk assessments and risk mitigation

measures, where appropriate, are being conducted. The individual dietary assessment for the

organophosphate phosalone has been completed, and will be used in the cumulative assessment of all of

the organophosphate chemicals, to satisfy the requirements of FQPA.

Phosalone is not registered for use in the United States; however, there are nine import

tolerances on almonds, grapes, pome and stone fruits for this chemical. Because it is not registered in

the U.S., it is not subject to the reregistration process. It is subject to the requirements of FQPA;

therefore, a dietary risk assessment was completed. This document presents the Agency’s dietary risk

assessment for phosalone, as part of the tolerance reassessment process. Note that there is no

comment period for this document. As part of the process developed by the TRAC, which sought to

open up the process to interested parties, the Agency’s risk assessment for phosalone has already been

subject to numerous public comment periods, and a further comment period was deemed unnecessary. 

A Notice of Availability for this document is being published in the Federal Register. The Phase 6 of

the pilot process did not include a public comment period; however, for some chemicals, the Agency

may provide for another comment period, depending on the content of the risk management decision.

The implementation of FQPA has required the Agency to revisit some of its existing policies

relating to the determination and regulation of dietary risk, and has also raised a number of new issues

for which policies need to be created. These issues were refined and developed through collaboration

between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was

composed of representatives from industry, environmental groups, and other interested parties. The
2

TRAC identified the following science policy issues it believed were key to the implementation of 

FQPA and tolerance reassessment:

• Applying the FQPA 10-Fold Safety Factor

• Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments 

• How to Interpret "No Detectable Residues" in Dietary Exposure Assessments

• Refining Dietary (Food) Exposure Estimates

• Refining Dietary (Drinking Water) Exposure Estimates

• Assessing Residential Exposure

• Aggregating Exposure from all Non-Occupational Sources

• How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with

a Common Mechanism of Toxicity

• Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates

• Whether and How to Use Data Derived from Human Studies

The process developed by the TRAC calls for EPA to provide one or more documents for

public comment on each of the policy issues described above. Each of these issues is evolving and in a

different stage of refinement. Some issue papers have already been published for comment in the

Federal Register and others will be published shortly.

This document consists of six sections. Section I contains the regulatory framework for

reregistration/tolerance reassessment as well as a description of the process developed by TRAC for

public comment on science policy issues for the organophosphate pesticides. Section II provides a

profile of the usage of the chemical. Section III gives an overview of the dietary risk assessment for

phosalone, including a discussion of any revisions that were made to the preliminary assessment. 

Section IV presents the Agency's progress towards tolerance reassessment, its interim decision and the

regulatory position on this chemical. Section V discusses what the manufacturer’s obligations are with

respect to further actions required, and finally, Section VI provides information on how to access

related documents. The entire revised risk assessment is not included in this document, but is available

on the Agency's web page (www.epa.gov/pesticides/op/phosalone.htm), and in the Public Docket. 

II. CHEMICAL OVERVIEW

A. Regulatory History

Phosalone is an organophosphate insecticide/acaricide first registered in 1969. All U.S.

registrations were voluntarily canceled in 1989 by the registrant at that time, Rhone-Poulenc Ag

Company (RPAC). The Agency proposed to revoke all phosalone tolerances in 1998 (63 FR 3057). 

However, in response to this proposal, RPAC (now Aventis CropScience) requested that the Agency

not revoke tolerances for phosalone residues in/on almonds, grapes, pome fruits (apples and pears),

and stone fruits (apricots, cherries, peaches, and plums) so that these commodities bearing phosalone

could continue to be imported legally into the U.S. In the Final Rule published in the Federal Register
3

of 10/26/98, the Agency maintained existing tolerances for residues of phosalone in/on the specified

commodities: almond (hulls), almonds, apples, apricots, cherries, grapes, peaches, pears, and plums

(fresh prunes), while revoking the remaining phosalone tolerances under (40 CFR §180.263) and (40

CFR §186.4800).

Permanent tolerances of 0.1 to 50.0 ppm(s) have been established by the U.S. EPA under 40

CFR §180.263 for residues of phosalone in/on almonds, almond hulls, grapes, apples, apricots,

cherries, peaches, pears, and plums imported into this country. Products containing the active

ingredient phosalone are registered and marketed in a number of countries (mostly in Europe), primarily

to tree crops and grapes, which may be treated and exported from those countries to the U.S. 

However, the current use pattern is very limited in comparison to what may be specified on the label

because of the entry of other pest control products, use within IPM systems, marketing strategies and

changed grower practices.

B. Chemical Identification

• Common Name: Phosalone

• Chemical Name: (O,O-diethyl S-[(6-chloro-2-oxobenzoaxzolin3-yl)methyl] phosphorodithioate)

• Chemical Family: Organophosphate 

• CAS Registry Number: 2310-17-0

• OPP Chemical Code: 097701

• Empirical Formula: C12H15CINO4PS2

• Molecular Weight: 367.80

• Trade and Other Names: Zolone, Rubitox

• Basic Manufacturers: Aventis CropScience
4

A detailed discussion on the physical properties of phosalone can be found in the EPA

document entitled "Phosalone: Preliminary Human Health Risk Assessment," dated November 1, 1999.

C. Use Profile

The following information is based on the current uses of phosalone outside of the United

States, and includes an overview of use sites and application methods. Phosalone is registered 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 for use on almonds, grapes, pome and stone fruits. Phosalone is not

registered under FIFRA and may not be sold, distributed, or used in the U.S. 

Type of Pesticide: Insecticide/Acaricide

Summary of Use Sites: Import only: Almond (hulls), Almonds, Apples,

Apricots, Cherries, Grapes, Peaches, Pears, Plums

(fresh prunes).

Target Pests: Phosalone is used to control mites, apple rust mite,

broad mite, brown almond mite, brown mite, spruce

spider mite, citrus red mite, European red mite, Pacific

spider mite, two-spotted spider mite, thrips, citrus

thrips, Colorado potato beetle, plum curculio, pecan

weevil, chrysanthemum leafminer, cherry fruit fly,

walnut husk fly, apple maggot, whiteflies, aphids, citrus

aphids, pecan aphids, buckthorn aphid, apple aphid,

green apple aphid, leafcurl plum aphid, thistle aphid,

black peach aphid, walnut aphid, rosy apple aphid,

wooly apple aphid, potato aphid, rose, aphid, filbert

aphid, black cherry aphid, green peach aphid, hop

aphid, black pecan aphid, pecan spittlebug,

leafhoppers, potato leafhopper, grape, leafhopper,

variegated leafhopper, pecan phylloxera, grape

phylloxera, pear psylla, European apple sawfly, peach

twig borer, potato tuberworm, green fruitworm,

orangedog, plume moths, pecan nut casebearer,

mineola moth, European corn borer, fruittree leafroller,

redbanded leafroller, obliquebanded leafroller,

omnivorous leafroller, European leafroller, filbert

leafroller, oriental fruit moth, hickory shuckworm,

codling moth, filbert worm, grape berry moth,

eyespotted bud moth. 
5

Formulation Types: There are three basic formulations

manufactured: emulsifiable concentrate (2.91

lb/gallon/ai), flowable concentrate (4.17

lb/gallon/ai), and wettable powder (30%). In a

very few countries, a local formulation is used. 

Local formulations are simply more dilute

versions of either the (2.91 lb/gallon/ai) EC or

the 30% WP, using the same inerts but in

higher quantity to achieve a lower assay. 

Method and Rates of Application:

Equipment- Ground and/or aerial equipment.

Method and Rate - Phosalone is applied as broadcast foliar applications

using ground or aerial equipment. The maximum use

rate per season on labels ranges from 1.6 lb

ai/acre/season to 4.0 lb ai/acre/season, however, labels

for non-EU countries (Turkey, Czech Republic, and

Slovak Republic) do not specify the maximum number

of applications allowed.

Timing - Actual use practices typically result in significantly

longer (<35 days) preharvest intervals, no more than 2-

3 applications per year at timings determined by pest

pressure and official recommendations.

Use Classification: N/A -- Not registered for use in the U.S.

D. Estimated Usage of Pesticide

This section summarizes the best estimates available for the pesticide uses of phosalone. These

estimates are derived from a variety of published and proprietary sources available to the Agency. The

data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as

the variability in using data from various sources.

The market share of phosalone among the exporting countries (preceding section labeled:

Summary of Use Sites) is minimal. The percent of almonds, apples, apple juice, apricots, cherries,

grapes, raisins, peaches, pears, and plums derived from countries possessing phosalone registrations

was assessed using statistics submitted by RPAC (now Aventis CropScience) quantifying the amount of

each commodity available for U.S. consumption from both domestic and foreign sources. It is
6

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. These

statistics, which reflect U.S. production data from the USDA National Agricultural Statistics Service

averaged from 1992-1996 plus U.S. import data from the U.S. Department of Commerce averaged

from 1992-1996, were used to generate the values summarized in Table 1. The FDA monitoring data

for 1992-1998 support these numbers.
7

Table 1. Phosalone Usage Information

Crop Commodity

Total Available for

U.S. Consumption

from Domestic +

Foreign Sources 

(1000 lbs.)

Total from

Domestic

Sources

 (1000 lbs.)

Total from

Foreign

Sources a

Total from

Exporting Countries

with Phosalone

Registered 

 (1000 lbs.)

Total from Exporting

Countries without

Phosalone Registered a

(1000 lbs.)

% from

Countries

with

Phosalone

Registered

Almonds nutmeat 532,714 532,600 114 1 113 0.0002 %

Apples

fresh + dried 8,332,009 8,024,340 307,669 117,171 190,498 1.41 %

juice 4,913,086 2,458,660 2,454,426 294,785 1,775,168 6.0 %

Apricots

fresh + dried + pulp/prepared

or preserved + kernel (peach,

plum or other stone fruits)

222,569 193,644 28,925 857 28,068 0.39 %

Cherries

(Sweet & Tart

Varieties)

fresh 184,006 172,384 11,622 938 10,684 0.51 %

Grapes

fresh + juice + wine 11,005,780 9,463,988 1,541,792 418,220 1,046,579 3.8 %

raisins (fresh basis) 3,282,885 3,199,120 83,765 14,861 68,904 0.45 %

Peaches

(including

nectarines)

fresh 1,583,569 1,482,580 100,989 845 100,144 0.05 %

Pears

fresh (including quince) +

nesoi 9,413,574 9,279,200 134,374 6,051 128,323 0.06 %

Plums fresh + dried (fresh basis) 1,589,478 1,543,604 46,874 2,756 44,118 0.17 %

a The values in these columns do not account for countries without phosalone registrations that are responsible for <1% of the corresponding commodity imported

by the U.S.
8

III. Summary of Phosalone Risk Assessment

Following is a summary of EPA’s revised human health risk findings and conclusions for the

organophosphate pesticide phosalone, as fully presented in the revised risk assessment document,

"Phosalone: Revised Human Health Risk Assessment," dated June 12, 2000. The risk assessment

presented here forms the basis of the Agency’s interim risk management decision for phosalone only;

the Agency must complete a cumulative assessment of the risks of all organophosphate pesticides

before it can complete its reassessment of the phosalone tolerances. 

Because phosalone is not currently registered for use in the U.S., only a human health dietary

assessment from exposure to this chemical through food was necessary. 

A. Human Health Risk Assessment

During the comment periods on the phosalone human health risk assessment, the only

comments received were from the registrant, Aventis CropScience. The Agency reviewed the

comments and no substantive revisions were made to the risk assessment. However, based on these

comments and recently submitted data, the Agency has decided to waive and/or reduce the number of

field trials required to support tolerance reassessment. Since phosalone has no U.S. registrations, the

assessment did not address ecological, drinking water, or occupational risk issues. The only source of

possible human exposure is through residues in imported foods and the conclusion of the assessment

indicated that food risk from phosalone is below the Agency’s level of concern.

1. Dietary Risk from Food

a. Toxicity

EPA has determined that it is appropriate to treat the organophosphates (OPs) as sharing a

common mechanism of toxicity because of their common mode of action, which inhibits cholinesterase

(ChE) activity. As required by FQPA, a cumulative assessment will need to be conducted to evaluate

the risk from food, water, and non-occupational exposure resulting from all uses of OPs.

Information from blood cholinesterase inhibition data is considered to provide important insights

into potential hazard. Although red blood cell (RBC) measures of acetylcholinesterase (AchE) are

generally preferred over plasma measures of cholinesterase activity, the Agency may use plasma

cholinesterase inhibition data under certain circumstances, such as if red blood cell data are insufficient,

of poor quality, or unavailable; if there is a lack of dose-dependency for the red blood cell

acetylcholinesterase inhibition; or, if the dose responses for inhibition of plasma cholinesterase more

closely approximate those for AchE inhibition in the nervous system than do the dose responses for

RBC acetylcholinesterase inhibition. 
9

NOAELs were not determined for plasma ChE inhibition in the acute rat neurotoxicity study;

for systemic effects or plasma, RBC, or brain ChE inhibition in the subchronic rat neurotoxicity study;

for plasma ChE inhibition in the chronic dog study; for plasma or RBC ChE inhibition in the mouse

carcinogenicity study; or for RBC ChE inhibition in the reproduction study. The lack of NOAELs in

these studies did not interfere with endpoint selection and the toxicology database is considered

adequate and of good quality.

The Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicological

database for phosalone and selected toxicity endpoints for dietary exposure. The ensuing table (Table

2) contains a summary of the doses and toxicity endpoints selected for use in the human health risk

assessment. 

Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary

Risk Assessment of Phosalone. 

Exposure

Dose 

(mg/kg/day)

Endpoint Study

Acute Dietary

(General population including

infants and children)

LOAEL = 10 Plasma ChE inhibition Acute neurotoxicity

in rats

 UF =300 Acute RfD = Acute PAD = 0.03 mg/kg /day

Acute Dietary

(Females 13+)

Developmental 

NOAEL = 1 Post-implantation loss Developmentaltoxicity in rabbits

 UF =100 Acute RfD = Acute PAD = 0.01 mg/kg /day

Chronic Dietary

NOAEL = 0.2 Plasma and RBC ChE inhibition (both sexes),

decreased testicular weight and lesions 2-Year Rat Study 

 UF =100 Chronic RfD = Chronic PAD = 0.002 mg/kg/day

b. FQPA Safety Factor

 The FQPA Safety Factor was reduced to 1X. The toxicity database includes an acceptable

two-generation reproduction study in rats and acceptable prenatal developmental toxicity studies in rats

and rabbits. These studies show no increased sensitivity to fetuses as compared to maternal animals

following acute in utero exposure in the developmental rat and rabbit studies and no increased

sensitivity to pups as compared to adults in a multi-generation reproduction study in rats. There was no

evidence of abnormalities in the development of the fetal nervous system in the pre/post natal studies. 

Adequate actual data, surrogate data, and/or modeling outputs are available to satisfactorily assess

dietary exposure. The assumptions and models used in the assessments do not underestimate the

potential risk for infants and children. Therefore, the additional 10X factor as required by FQPA was

reduced to 1X.

It must be noted that in the prenatal developmental toxicity study in rats and the two-generation

reproduction study in rats, effects in the fetuses/offspring were observed at doses higher than those
10

producing maternal/paternal effects. The effects observed in the fetuses/offspring are not considered a

true quantitative increase in fetal sensitivity, due to two reasons. First, the endpoint of 1 mg/kg/day is a

very conservative indicator of toxicity because it is based on total resorptions and is not a litter effect. 

Second, although cholinesterase activity was not determined in the study, it is likely that significant

cholinesterase inhibition occurred at 20 mg/kg/day, considering the severity of the maternal clinical signs

(labored breathing, abdominal cramps, extension spasms, prostration). Based upon information from

other studies, it is presumed that cholinesterase activity was also inhibited in the maternal rabbits at 10

mg/kg/day. Therefore, ChE determinations would most likely have shown the maternal NOAEL to be

the same as the developmental NOAEL or lower.

c. Population Adjusted Dose (PAD)

 The PAD is a term that characterizes the dietary risk of a chemical, and reflects the Reference

Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e.,

RfD/FQPA safety factor). For the acute dietary assessment, risk is calculated considering what is

eaten in one day (consumption) and residue values in the food. For chronic exposures, dietary risk is

calculated by using the average consumption value for food and average residue value. In the case of

phosalone, the FQPA safety factor is 1X; therefore, the acute or chronic Reference Dose (RfD) = the

acute or chronic Population Adjusted Dose (PAD). A risk estimate that is less than 100% of the acute

or chronic PAD does not exceed the Agency’s risk concern.

d. Exposure Assumptions

Revised acute and chronic dietary risk analyses for phosalone were conducted with the Dietary

Exposure Evaluation Model (DEEMTM). DEEM incorporates consumption data generated in USDA’s

Continuing Survey of Food Intakes by Individuals (CSFII), 1989-91. Acute and chronic dietary

analyses were also conducted using anticipated residues (ARs) based on FDA Surveillance Monitoring

data. Anticipated residues on almonds and cherries were calculated from field trial results due to lack

of sufficient monitoring data. Although USDA/PDP data were available for some commodities, the

FDA data were preferable due to a larger number of samples of foods imported from countries having

phosalone registrations. In the case of almonds where there were non-detectable residues, 1⁄2 the limit

of detection was used in the dietary exposure assessments. The acute and chronic analyses take into

consideration the reduction of phosalone residues in certain processed foods.

Based on available livestock metabolism and feeding studies, it has been determined that there

is no reasonable expectation of finite residues being transferred into livestock commodities from feed

items bearing phosalone residues, i.e., a 180.6(a)(3) classification is appropriate. With regards to wet

apple pomace, the majority of apple imports are in the form of juice (84%), with 9% of apple imports

being fresh fruit. It is unlikely that these imported apples will be used for processing; therefore,

domestic livestock are unlikely to be fed wet apple pomace bearing phosalone residues. In addition, of

the countries with registered uses of phosalone on apples, only Canada exports significant quantities of
11

beef (3% of available commodity) to the U.S. If the percentage of the apple crop treated with

phosalone in Canada (6.5%) is also considered, then only 0.2% of the available beef supply could

possibly contain phosalone residues. As a result, tolerances for phosalone residues in livestock

commodities are not necessary. Consequently, the dietary exposure assessments reflected no

consumption of livestock commodities.

e. Acute Food Risk 

An acute dietary assessment was conducted for phosalone. A Tier 3 probabilistic (Monte

Carlo) technique was used in order that the high-end (or low end) consumer had an equal chance of

getting a high or low dose residue level. A risk estimate that is less than 100% of the (aPAD), the dose

at which an individual could be exposed on any given day that would not be expected to result in

adverse health effects, does not exceed the Agency’s risk concern. Results at the 99.9th percentile of

exposure for all population subgroups (<0.74% of the aPAD) confirm that the current residue levels do

not exceed the Agency’s risk concern. This estimate has been highly refined using Monte Carlo

analysis and FDA monitoring data as the principal source of anticipated residues.

The aPAD for the general population (including infants and children) is 0.03 mg/kg/day. This

endpoint is from an acute neurotoxicity study in the rats with a LOAEL of 10 mg/kg/day, the lowest

dose tested. Although a NOAEL for plasma cholinesterase was not determined in this study, the

LOAEL is believed to be close to a NOAEL, as neither brain nor RBC cholinesterase were statistically

significantly inhibited at 10 mg/kg or 25 mg/kg in this study. Uncertainty factors total 300X (10X for

interspecies extrapolation, 10X for intraspecies variation, and 3X for lack of a NOAEL).

f. Chronic Food Risk

The chronic dietary risk assessment is achieved by combining the average consumption values

for food and average residue values for those foods, for each population subgroup, over a 70-year

lifetime to determine average exposure in mg/kg/day. Based upon achieved modeling numbers, DEEM

estimates that all population subgroups are chronically exposed to phosalone at a level less than the

phosalone chronic Population Adjusted Dose (cPAD). Chronic risks to all population subgroups was

0.1% or less of the cPAD. The chronic dietary risk from phosalone residues in food alone is also

below the Agency’s level of concern.

In summary, acute risks to all population subgroups were <0.74% of the aPAD and chronic

risks to all population subgroups were <0.1% of the cPAD, well below the Agency’s levels of concern.

Below in Table 3 is a representation of these risk estimates.
12

Table 3. Summary of Phosalone Acute & Chronic Non-cancer Dietary Exposure and Risk

Estimates 1

Population Subgroup

Acute Assessment (99.9th %-ile of Exposure)

General U.S. Population Chronic Assessment

Including All Infants and

Children Subgroups

Females 13+

Exposure

(mg/kg/day) % aPAD

Exposure

(mg/kg/day) % aPAD Exposure(mg/kg/day) % cPAD

General U.S. Population 0.000049 0.16 N/A N/A 0.000001 0.0

All Infants (<1 yr) 0.000084 0.28 N/A N/A 0.000001 0.1

Children (1-6 yrs) 0.000221 0.74 N/A N/A 0.000002 0.1

Children (7-12 yrs) 0.000132 0.44 N/A N/A 0.000001 0.0

Females (13-50 yrs) 0.000016 0.05 0.000017 0.17 0.000000 0.0

Males (13-19 yrs) 0.000014 0.05 N/A N/A 0.000000 0.0

Males (20+ yrs) 0.000017 0.06 N/A N/A 0.000000 0.0

1The Acute Population Adjusted Doses (aPADs) are 0.03 mg/kg/day for the “General U.S. Population Including All

Infants and Children Subgroups” and 0.01 mg/kg/day for “Females 13+.” The Chronic PAD (cPAD) is 0.002

mg/kg/day for all population subgroups. 

IV. FQPA Tolerance Reassessment Progress & Interim Risk Management Decision

A. Tolerance Reassessment Progress & Interim Risk Management Decision

The Agency has completed its assessment of the dietary risk of phosalone but has not

considered the cumulative effects of organophosphates as a class. Based on a review of these generic

data and public comments on the Agency’s revised risk assessment for the active ingredient phosalone,

EPA has sufficient information on the human health effects of phosalone to make some interim decisions

as part of the tolerance reassessment process under FQPA. Although the Agency has not yet

completed its cumulative risk assessment for the organophosphates, the Agency has completed its

assessment of risk from dietary exposure to phosalone alone in order to determine whether any risk

reduction measures are necessary to allow the continued importation of almonds, apples, apricots,

cherries, grapes, peaches, pears, and plums containing this chemical, pending completion of the

cumulative assessment. 

As a result of its assessment, EPA has determined that dietary risk from exposure to phosalone

does not exceed the Agency’s level of concern. Therefore, no mitigation is necessary and no further

actions are warranted at this time. The Agency may determine, however, that further action is

necessary after assessing the cumulative risk of the organophosphate class. At that time, the Agency

will also address any other outstanding risk concerns that may arise. Such an incremental approach to

the tolerance reassessment process is consistent with the Agency’s goal of improving the transparency
13

of the implementation of FQPA. By evaluating each organophosphate in turn and identifying

appropriate risk reduction measures, the Agency is addressing the risks from the organophosphates in

as timely a manner as possible.

Because the Agency has not yet completed the cumulative risk assessment for the

organophosphates, this interim decision does not specifically address the reassessment of the existing

phosalone food residue import tolerances as called for by the FQPA. When the Agency has

completed the cumulative assessment, the phosalone tolerances will be reassessed in that light. At that

time, the Agency will reassess phosalone along with the other organophosphate pesticides to complete

the FQPA requirements. Nothing in this report will preclude the Agency from making further FQPA

determinations and tolerance-related rulemaking that may be required on this pesticide or any other in

the future. 

If the Agency determines, before finalization of the FQPA assessment for phosalone, that any of

the determinations described in this document are no longer appropriate, the Agency will pursue

appropriate action, including but not limited to, reconsideration of any portion of this document. 

B. Summary of Phase 5 Comments

EPA released its revised risk assessment for phosalone to the public in July 26, 2000, and 

provided a 60 day comment period for interested parties to submit information, including risk mitigation

suggestions or proposals. During this time, no comments were received in relation to this comment

period.

C. Regulatory Position

1. FQPA Assessment

a. “Risk Cup” Determination

As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with

this individual organophosphate. FQPA also requires the Agency to consider available information on

cumulative risk from substances sharing a common mechanism of toxicity, such as the toxicity

expressed by the organophosphates through a common biochemical interaction with cholinesterase

enzyme. The Agency will evaluate the cumulative risk posed by the entire class of organophosphates

once the methodology is developed and the policy concerning cumulative assessments is resolved. 

EPA has determined that risk from exposure to phosalone is within its own “risk cup.” In other

words, if phosalone did not share a common mechanism of toxicity with other chemicals, EPA would

be able to conclude today that the import tolerance for phosalone on almonds, grapes, apples, apricots,

cherries, peaches, pears, and plums meets the FQPA safety standards. In reaching this determination,
14

EPA has considered the available information on the special sensitivity of infants and children, as well as

chronic and acute food exposure. An aggregate assessment was not conducted for phosalone, because

there are no domestic uses. But, results of the acute and chronic food assessments indicate that

exposures are within acceptable levels; that is, risk from exposure to phosalone “fits” within the

individual risk cup. Therefore, the import tolerance remains in effect and unchanged until a full

reassessment of the cumulative risk from all organophosphates is completed. 

b. Tolerance Summary

The established tolerance for residues of phosalone in/on plant commodities is currently

expressed in terms of residues of phosalone per se (S-(6-chloro-3-(mercaptomethyl)-2-

benzoxazolinone)O,O,-diethyl phosphorodithioate) [40 CFR §180.263]. It should be noted, however,

that the preferred chemical name for phosalone is (O,O-diethyl S-[(6-chloro-2-oxobenzoxazolin-3-

yl)methyl] phosphorodithioate). The referenced tolerances for residues of phosalone in/on plant

commodities are outlined in Table 4 of this document.

Because the grape use will be deleted from French labels in the near future, it has been decided

that additional field trial studies need to be conducted solely in Canada reflecting their Good

Agricultural Practices (GAP). The tolerances are to reflect the Canadian use pattern on grapes, apples,

pears, cherries, peaches, and plums. In response to Aventis’ comments, the Agency has decided to

waive pear field trials and reduce the number of trials required on peaches and plums. However,

several side-by-side field trials have been determined necessary to compare residues resulting from the

application of two major formulation classes.

 It is recommended that both the EC and either the WP or FLC be applied in side-by-side

studies involving two major grape growing regions and that the re-treatment intervals being tested

should mirror common commercial practice.

The same scenario is true for side-by-side studies involving apples, but only one additional trial,

conducted in Canada in one major grape growing region, is recommended. The field trial is to

encompass the EC and either the WP or FLC to be applied in side-by-side Canadian trials. In

conjunction, due to the very low percentage of imported pears available for consumption, the Agency

has decided not to require pear field trials. It is important to state that a pome fruit crop group

tolerance may not be established without the additional two pear field trials which would reflect the

Canadian GAP. 

The new Canadian cherry field trials tentatively satisfy the requirements to support an import 

tolerance. Depending upon whether or not these side-by-side studies on other crops indicate

differences between residues, resulting from different formulation classes, additional cherry field trials

may be required testing the EC formulation. 
15

In respect to peaches and plums, EPA is reducing the number of trials to be conducted from

three to two each, but to require side-by-side trials testing the EC and either the FLC or WP. These

trials should reflect the Canadian GAP. 

Table 4. Tolerance Reassessment Summary for Phosalone.

Commodity

Current

Tolerance

(ppm)

Tolerance

Reassessment

(ppm)

Comment/Correct Commodity Definition

Tolerances listed under 40 CFR §180.263:

Almonds 0.1 0.1 Almond, nutmeat

Almonds, hulls 50.0 Revoke Almond hulls are not imported.

Apples 10.0 TBD a The available data indicate that the established

tolerances are too high and may be lowered to 1.0 ppm

for residues in/on grapes and stone fruits, and 2.0 ppm

for residues in/on pome fruits. However, additional

data reflecting the slightly higher use rate of the

Canadian GAP are required before the tolerances can be

reassessed.

Apricots 15.0

Cherries 15.0

Grapes 10.0

Peaches 15.0

Pears 10.0

Plums (fresh prunes) 15.0

Tolerances needed under 40 CFR §180.263

Raisins None TBD Additional data on grapes are needed to assess an

appropriate tolerance for residues in raisins. Phosalone

residues concentrate by ~2X in raisins.

Prunes None TBD To assess an appropriate tolerance for residues in

prunes, data are needed from field trials on plums. 

Phosalone residues concentrate by a maximum of ~2x in

prunes. 

Pome fruits None TBD The available residue data on imported apples, pears,

peaches, and cherries suggest that crop group

tolerances may be appropriate for pome and stone

fruits. If the requested residue data on pome and stone

fruits from Canadian studies are similar to the available

data from Europe and Japan, then crop groups should

be established for pome fruits and stone fruits

concomitant with revoking the individual tolerances for

the members of these crop groups.

Stone fruits None TBD

a TBD = To be determined. Tolerance cannot be determined at this time because additional data are required.

2. Endocrine Disruptor Effects

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to

determine whether certain substances (including all pesticide active and other ingredients) "may have an

effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such

endocrine effects as the Administrator may designate." Following the recommendations of its
16

Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that

there was scientific bases for including, as part of the program, the androgen and thyroid hormone

systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommendation

that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will

use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have

an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and

resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor

Screening Program (EDSP).

When the appropriate screening and/or testing protocols being considered under the Agency’s

EDSP have been developed, phosalone may be subjected to additional screening and/or testing to

better characterize effects related to endocrine disruption.

D. Regulatory Rationale

Phosalone has nine tolerances, and no U.S. registrations; therefore, only a dietary risk

assessment for food was conducted. Based on analyses of both acute and chronic dietary risk, the

Agency has determined that the risk estimates are below the Agency’s level of concern; therefore, no

mitigation measures are necessary at this time.

V. What Manufacturers Must Do

A. Additional Data Requirements

EPA is requiring acute, subchronic, and developmental neurotoxicity studies for all

organophosphates, including those with no domestic registrations (i.e., tolerances are established only

to allow treated commodities to be imported into the U.S.). Although phosalone has no U.S.

registrations and therefore is not subject to a FIFRA DCI, it does have a tolerance or tolerances for

almonds, grapes, pome and stone fruits that are imported into the U.S. EPA is currently working to

require the submission of acute, subchronic, and developmental neurotoxicity studies under the authority

of FFDCA. Results of these studies may further refine the risk assessments.

In addition, the In Vitro Unscheduled DNA Synthesis (UDS) Assay has been recommended to

be repeated in order to confirm the findings of an earlier study indicating weak UDS-inducing activity. 

Likewise, the General Metabolism Study (in rats) has been deemed unacceptable, due to the majority

of the radioactivity in urine not being identifiable. Additional data have been requested in order to

upgrade the study to an acceptable status. In compliance with regulatory policy, the registrant (Aventis

CropScience) has planned a new rat metabolism study for initiation in approximately April 2000. This

study is being initiated in connection to the requested additional data, metabolite identification in urine,

which was not possible due to the unavailability of samples for further analysis.
17

Additional Field Trials:

Peach and Plum field trials have been reduced from three to two each, but to require side-byside trials testing the EC and either the FLC or WP. These trials should reflect the Canadian

GAP.

Grape field trials are to include both the EC and either the WP or FLC to be applied in sideby-side studies involving two major grape growing regions and that the re-treatment intervals

being tested mirror common commercial practice.

An apple field trial study is to be conducted in Canada in one major grape growing region,

involving one additional side-by-side trial encompassing the EC and either the WP or FLC. It

is important to state that a pome fruit crop group tolerance may not be established

without the additional two pear field trials which would reflect the Canadian GAP.

*(New Canadian cherry field trials tentatively satisfy the requirements to support an import

tolerance. Depending upon whether or not these side-by-side studies on other crops indicate

differences between residues, resulting from different formulation classes, additional cherry field

trials may be required testing the EC formulation).

B. Risk Mitigation Requirements

As discussed in this document, the acute and chronic food risk from the use of phosalone on

almonds, grapes, and certain pome and stone fruits is not of concern to the Agency; therefore, no

mitigation is necessary at this time. The Agency may need to pursue further risk management measures

for phosalone once the cumulative assessment is finalized.

VI. Related Documents and How to Access Them

This report is supported by documents that are presently maintained in the OPP docket. The

OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

It is open Monday through Friday, excluding legal holidays from 8:30 am to 4 pm.

The docket initially contained preliminary risk assessments and related documents as of

September 10, 1998. Sixty days later the first public comment period closed. The EPA then

considered comments, revised the risk assessment, and added the formal “Response to Comments”

document and the revised risk assessment to the docket on July 7, 1999.

All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or

viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op/phosalone.htm."
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______________________________________________________________________________

18

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19

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44792043 Maestracci, M. (1997) Phosalone: Formulation EXP06027B (SC) Trial France 1996

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