&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C1
EPA 738-R-01-001
January 2001
Report on FQPA Tolerance
Reassessment Progress
and Interim Risk
Management Decision for
Phosalone
-------
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA 738-F-01-001
January 2001
4>EFW 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 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 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 andnsk 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.
-------
Uses
An msecticide/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/o 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/RF.Ds/ or
www.epa.gov/pe.sficides/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:
FCB
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 multi-stakeholder 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
GLOSSARY OF TERMS AND ABBREVIATIONS «
EXECUTIVE SUMMARY '.'.'.'.".
OVERALL RISK SUMMARY V
I. INTRODUCTION l
H. CHEMICAL OVERVIEW 2
A. Regulatory History 2
B. Chemical Identification *
C. UseProfile '.'.'.".*"".'""!.'!."!.".*.".*.".".'.""] 4
D. Estimated Usage of Pesticide 5
HI. SUMMARY OF PHOSLAONE RISK ASSESSMENT 8
A. Human Health Risk Assessment 8
1. Dietary Risk from Food o
a. Toxicity 8
b. FQPA Safety Factor ........!.....!!!!!. 9
c. Population Adjusted Dose (PAD) 10
d. Exposure Assumptions 10
e. Acute Food Risk H
f. Chronic Food Risk H
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 Disrupters 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 ,0
lo
-------
-------
PHOSALONE TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Kristina El-Attar
Bill Hazel
KitFarwell
Use and Usage Analysis
Jihad Alsadek
Mike Hennessey
Registration Support
N/A
Risk Management
John I^ahy
John Pates
-------
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
AE
a.i.
AGDCI
ai
aPAD
AR
ARC
BCF
CAS
CI
CNS
cPAD
CSF
CFR
CSFII
DCI
DEEM
DFR
ORES
DWEL
DWLOC
EC
EEC
EP
EPA
FAO
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLC
GLN
GM
GRAS
HA
HAFT
HOT
BR
LC50
Acid Equivalent
Active Ingredient
Agricultural Data Call-in
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Anticipated Residue Contribution
Bioconcentration Factor
Chemical Abstracts Service
Cation
Central Nervous System
Chronic Population Adjusted Dose
Confidential Statement of Formula
Code of Federal Regulations
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In ..,,. ...'..
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
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.
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Gas Liquid Chromatography
Guideline Number
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination situations occur.
Highest Average Field Trial
Highest Dose Tested
Index Reservoir
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/1, mg/kg or ppm.
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
LDj0 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
LOG 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
PDF 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
Q,* The Carcinogenic Potential of a Compound, Quantified by the EP A's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell :
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
ID.
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
RQ
RS
RUP
SAP
SCI-GROW
SF
SLC
SLN
TC
TD
TEP
TGAI
TLC
TMRC
torr
TRR
UF
Hg/g
USDA
USGS
UV
WHO
WP
WPS
Risk Quotient
Registration Standard
Restricted Use Pesticide
Science Advisory Panel
Tier I Ground Water Computer Model
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Total Radioactive Residue "•*- '
Uncertainty Factor
Micrograms Per Gram
Micrograms Per Liter
United States Department of Agriculture
United States Geological Survey
Ultraviolet
World Health Organization
Wettable Powder
Worker Protection Standard
IV
-------
-------
Executive Summary
its risk
te nskmamgem
°f PUMC COmmentS °n fce revised risk ««««*
for phosalone, an organophosphate insecticide,
issuing
Ph°salone non
comment periods in the open process developed ftraugh the Tolerance
Reassessment Advisory Committee (TRAC). luicrdnce
OveraU 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
ZSTl^T'l^^
ZnoT^n Tdr ^ ?*?*«»* ensures' as well as dietary exposure through drinking watT
are not expected because there * no domestic use of phosalone. Therefore, aggregate acute and
C n "
fh , sure- se
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. concern,
*« ^e tole^^essment 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
nmentmeasuresforphosdone^^^
-------
VI
-------
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 FTFRA
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
-------
TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:
Applying the FQPA 10-Fold Safely 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 n provides a
profile of the usage of the chemical. Section IH 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.
H. 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
-------
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 8180 263) and (40
CFR§ 186.4800). V
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:
Chemical Name:
Phosalone
(O,O-diethylS-[(6-chloro-2-oxobenzoaxzolin-
3-yl)methyl] phosphorodithioate)
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Molecular Weight:
Organophosphate
2310-17-0
097701
C12HI5CIN04PS2
367.80
Trade and Other Names: Zolone, Rubitox
Basic Manufacturers: Aventis CropScience
3
-------
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:
Summary of Use Sites:
Target Pests:
Insecticide/Acaricide
Mport only: Almond (hulls), Almonds, Apples,
Apricots, Cherries, Grapes, Peaches, Pears, Plums
(fresh prunes).
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 leafrniner, 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, bkck cherry aphid, green peach aphid, hop
aphid, black pecan aphid, pecan spittiebug,
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.
-------
Formulation Types:
There are three basic formulations
manufactured: emulsifiable concentrate (2.91
Ib/gallon/ai), flowable concentrate (4.17
Ib/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 Ib/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-
Method and Rate -
Ground and/or aerial equipment.
Phosalone is applied as broadcast foliar applications
using ground or aerial equipment. The maximum use
rate per season on labels ranges from 1.6 Ib
ai/acre/season to 4.0 Ib ai/acre/season, however, labels
for non-EU countries (Turkey, Czech Republic, and
Slovak Republic) do not specify the maximum number
of applications allowed.
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
-------
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.
-------
O
03
S
j§
c
o
.28 <
B S § * ->
1 o "« S £
* 0 S S o
o «£* ^
O, > ,
B) - 1
* ?
0 CS "to
^ 1 s 1 1
**^ U M ®
*~* • S *£> C^
gS^I
1
1 - „
's
5
i w
^
>
D.
S
0
^
e»
§
O
o
en
-
^
^*
o
VO
g
g
tn
[nutmeat
[Almonds
•^
2
1
o
1
OA
i
o
•a-
en
•*"
fS
o
oo"
o\
0
CN"
en
oo
•o
V
[fresh + dri
o
O
VO
oo
vo
""^
oo
l>
(S
vo
rt-
rN
o
vo
VO
oo"
9
cs
VO
oo
en"
O\
^1"
U
'3
tn
JU
"p.
D.
"S
c\
en
o
oo
vo
O
oo"
CN
in
oo
>n
Si
oo"
01
vo
sf
s
>n
of
cs
1-g
O3 S 1o
°* S. •—
o, iT 2
"all
o, j4 S
•a -a o
u u J2
fresh + dri
or preserv
plum or ot
VI
0
u
a.
^p
o
S
VO
o"
OO
en
a\
S
^f
en
g
VO
§
S"
oo
.£3
CO
•K
to
[cherries
KSweet & 1
[Varieties)
oo
,046,579
T— «
O
06"
s
s
"
oo
oo
ON
rn"
oC
o
oo
r-
8"
^s
1—4
c
"it
+
o
1
<£
N?
^
in
0
I
oo"
VO
00
/.
•n
en"
00
§
oC
o\
en"
in
oo
00
cs"
oo
cs.
en"
CO
J
J3
U
CA
e
^co
"3
CO
p.
2
o
0
o
o
I
1
in
oo
"
oo
°X
O
o
oo
CN"
oo
r-T
\o
ir>
S3
--
JS
CA
eg
[Peaches
[(including
[nectarines]
a
§
o
en
en
06"
CS
o
VO
g
en
o
o
0)
oC
55
oC
S
"I
en
^
oC
~*~
o>
u
"1
•3
3
£ o
a
cd
£
o
t-
C5
00
i"
VO
CN
OO
s
\o
j?
i— r
00
5
ON
OO
**\
i— >
OQ
W
cd
XI
en
Ui
(D
C
.2
*«
CO
0
-C
p.
S
o
CO
O
"C
o
o
t-.
c
o
u
u
ed
0
o
e columns
CO
a>
•5
.S
CO
fl The value
by the U.S.
-------
IIL 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 phosalbrie 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.
-------
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 (fflARC) 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 * * \
Acute Dietary
(General population including
infants and children)
Acute Dietary
(Females 13+)
Chronic Dietary
Dose
(mg/kg/day)
LOAEL = 10
Endpoint t _:
Plasma ChE inhibition
Study " i_
Acute neurotoxicity
In rats
UF=300 Acute RfD = Acute PAD = 0.03 mg/kg/day
Developmental
NOAEL = 1
Post-implantation loss
Developmental
toxicity in rabbits
UF = 1 00 Acute RfD = Acute PAD = 0.01 rag/kg /day
NOAEL = 0.2
Plasma and RBC ChE inhibition (both sexes),
decreased testicular weight and lesions
2- Year Rat Study
UF = 1 00 Chronic RfD = Chronic PAD = 0.002 mg/kg/day
b. FQPA Safety Factor
The FQPA Safety Factor was reduced to IX. 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 IX.
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
-------
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 IX; 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 (DEEM™). DEEM incorporates consumption data generated in USDA's
Continuing Survey of Food Intakes by Individuals (CSFIT), 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, Ihe
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, % 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, Ihe 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
10
-------
beef (3 /o 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 avSable berf supplytuld
P^cootam phosalone residue, As a result, tolerances for phosalone residues in iLk
coZl TT? SSaiy" Conse c°™*™ *»* » «** chanc* of
getting a high or low dose residue level. A risk estimate that is less than 100% of the (aPAD) the dose
^^
. ^ 6XCeed ^ AgCnCy'S ^ COnCem" Results at *e "-^ P-entile of
noed A n ? b8K>qPS ^°-740/0 °f ^ ^^ C°llfinn ^ &e CUCTent «^c levels do
not exceed theAgency's nsk concern. This estimate has been highly ^refined using Monte Carlo
analysis and FDA monitoring data as the principal source of anticipated residues.
TheaPAD for the general population (including infants and children) is 0.03 mg/kg/day This
endpoin is from an acute neurotoxicity study in the rats with a LOAEL of 10 mg^g/dfy SwS
Sir^ °^LN?^Lforpl^chofc^^^
LOAEL is beheved to be close to a NOAEL, as neither brain nor RBC cholinesterase were tatisticaUv
^cmnyin^itedatlOmg^gor25mS/kginthiSstudy. Unce^ty factors total 3Z (^X for "
interspecies extrapolation, 10X for intraspecies variation, and 3X for lack of a NOAEL).
f. Chronic Food Risk
^ ^ aSSessment is achieved by combining the average consumption values
f°r flM8e f°0dS' f°r Cach P^^011 sub, over a 70-year
nh rODCay eXp°Sed to Phosalone at a kvel less thar the
•" pI>plllMi0
£0.74% of to aPAD md chronic
CPAD' WeU W°«"i- Agency's levels
3 is a representation of these risk estimates
11
-------
Table 3. Summary of Phosalone Acute & Chronic Non-cancer Dietary Exposure and Risk
Estimates *
j 1
• * — "£-"'_,
^ *- "fy-"!
Population Subgroup
-' - "" '"H" , rt
, "- k j!
General U.S. Population
All Infants (<1 yr)
Children (1 -6 yrs)
Children (7-12 yrs)
Females (13-50 yrs)
Males (13-19 yrs)
Males (20+ yrs)
Acute Assessment (99.9th %-ile of Exp'osure) '
General U.S. Population
Including All Infants and
Children Subgroups
Exposure
, (mg/kg/day)
0.000049
0.000084
0.000221
0.000132
0.000016
0.000014
0.000017
%raPAD
0.16
0.28
0.74
0.44
0.05
.0.05
0.06
r ? *
> , t
Females 13+ '
Exposure
(mg/kg/day)
N/A
N/A
N/A
N/A
0.000017
N/A . .
N/A
!
%aPADi
N/A
N/A
N/A
N/A
0.17
N/A
N/A
Chronic Assessment
Exposure
(mg/kg/day)
0.000001
0.000001
0.000002
0.000001
0.000000
0.000000
0.000000
% cJPAl}
0.0
0.1
0.1
0.0
0.0
0.0
0.0
•The 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
12
-------
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, '
13
-------
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)0,0,-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-oxobenzo-xazolin-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 Hie 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, chemes, peaches, and plums. In response to Aventis' comments, the Agency has decided to
wave 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.
14
-------
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
1 (ppm)
Tolerance
Reassessment
(ppm) '
Comment/Correct Commodity Definition
Tolerances listed under 40 CFR §180.263:
Almonds
Almonds, hulls
Apples
Apricots
Cherries
Grapes
Peaches
Pears
Plums (fresh prunes)
0.1
50.0
10.0
15.0
15.0
10.0
15.0
10.0
15.0
0.1
Revoke
TBD"
Almond, nutmeat
Almond hulls are not imported.
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.
Tolerances needed under 40 CFR §180.263
Raisins
Prunes
Pome fruits
Stone fruits
None
None
None
None
TBD
TBD
TBD
TBD
Additional data on grapes are needed to assess an
appropriate tolerance for residues in raisins. Phosalone
residues concentrate by ~2X in raisins.
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.
The available residue data on imported apples, pears,
3each.es, and cherries suggest that crop group
tolerances may be appropriate for pome and stone
fruits. If the requested residue data on pome and stone
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.
a TBD = To be determined. Tolerance cannot be determined at this time because additional data are required.
2. Endocrine Disrupter 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
15
-------
Endocrine Disrupter 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 aUow 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.
16
-------
Additional Field Trials:
Peach and Plum field trials have been reduced 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.
Grape field trials are to include both the EC and either the WP or FLC to be applied in side-
by-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."
17
-------
BIBLIOGRAPHY
MRID
CITATION
00006068
00006357
00006480
00006487
00006769
00062878
00062879
Guardigli, A. (1972) Phosalone Transfer in Fruits Processing: Possible Residue in Raw
Apple Juice and Dry Apple Pomace: Laboratory Experiments. (Unpublished study
received Feb 16,. 1972 under 2H5013; submitted by Rhodia, Inc., New Brunswick,
N.J.; CDL:221747-C)
Rhodia, Incorporated (1972) Phosalone Dried Apple Pomace Data. Includes undated
method. (Unpublished study received June 26,1972 under OF0983; prepared in
cooperation with Cornell University, New York State Agricultural Experiment Station,
Dept. of Food Science and Technology; CDL:091691-A)
Guardigli, A.; Martwinski, P. (1971) Residue Data: [Zolone]. (Unpublished study
including field test project nos. BB 65-63, BB 68-91, PA 68-46, PA 70-25/25A PA
70-26, PA 70-27/27AandPAW 70-29, receivedNov 18,1971 under 359-626;
prepared by Rhodia, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ.;CDL:003175-X)
Henckler, P.M.; Rice, R. (1973) Residue Summary: Plums: Project No. 180473-033.
(Unpublished study received Mar 29, 1974 under 359-620; prepared by Rhodia, Inc.
in cooperation with Univ. of California, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, N.J.; CDL:028124-G)
Guardigli, A. (1964) Laboratory Analytical Data Sheet for Residues: Field Test Project
No. BB 64-26. (Unpublished study received Feb 2,1967 under 7G0575; prepared
by Rhodia, Inc., submitted by Chipman Chemical Co., Inc., Burlingame Calif.-
CDL:090727-L)
Hutsell, T.C.; Mulkey, N.S.; Wargo, J.P., Jr.; et al. (1978) Research Report: 14 C-
Phosalone Sorghum Metabolism Study: ADC Project No. 299. (Unpublished study
received Dec 4,1980 under359-620; prepared by Analytical Development Corp.,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:099782-
A)
Penner, D. (1977) Sorghum Metabolism Study with 14 C-Phosalone: Report on: I.
Growing, Treatment, and Harvest of the Sorghum; H. 14 C-Phosalone Translocation
Study. (Unpublished study received Dec 4,1980 under 359-620; prepared by
Michigan State Univ., Dept. of Crop and Soil Sciences, submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:099782-B)
18
-------
BIBLIOGRAPHY
MRID
CITATION
00062880
00062881
00064522
00064523
00064524
00064525
00064528
Wargo, J.P., Jr.; Tessier, J.F.; Kruplak, J.F.; et al. (1980) Validation of Methods 54A
and 144 for the Determination of Phosalone and Metabolites in Raw Agricultural
Commodities: ADC Project # 460. (Unpublished study received Dec 4,1980 under
359-620; prepared by Analytical Development Corp., submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:099782-C)
Rhone-Poulenc Chemical Company (1978) Freezer Storage Stability Test on Alfalfa.
(Unpublished study received Dec 4,1980 under 359-620; CDL:099782-D)
Buys, M.; Guardigli, A (1980) Validated Enforcement Methodology for Animal
Substrates: FDD Report No. 80/016. Methodno. 155 dated Oct 1980. (Unpublished
study received Dec 4,1980 under 359-620; prepared in cooperation with Analytical
Development Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:099784-A)
Witkonton, S. (1980) Research Report: Validation of Analytical Methods for the
Determination of Phosalone and Its Metabolites in Milk and Animal Tissues: ADC
Project # 496. (Unpublished study received Dec 4, 1980 under 359-620; prepared
by Analytical Development Corp., submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:099784-B)
Craig, L.D.; Langknecht, J.C.; Adams, L.; et al. (1980) Research Report: Residue
Determination of Phosalone and Its Oxygen Analog in the Milk and Tissues of Dairy
Cattle by Electron Capture Gas Chromatography: ADC Project # 475-D. Includes
method dated May 16,1980. (Unpublished study, including ADC project #s 475-
A&B and 475-C, received Dec 4, 1980 under 359-620; prepared by Analytical
Development Corp., submitted by Rhone-Poulenc Chemical
Fox, S.E.; Langknecht, J.C.; Busemeyer, F.; et al. (1980) Research Report: Residue
Determination of Phosalone and Its Oxyon Analog in the Eggs and Tissues of
Chickens: ADC Project # 507. (Unpublished study received Dec 4, 1980 under 359-
620; prepared by Analytical Development Corp., submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:099785-B)
Fox, S.E.; Herrera, R. (1980) Research Report: Residue Determination of Metabolites
Containing the Chlorobenzoxazole Moiety in Tissues and Eggs from Laying Hens Fed
Phosalone: ADC Project # 507-A. (Unpublished study received Dec 4,1980 under
19
-------
BIBLIOGRAPHY
MRED
CITATION
359-620; prepared by Analytical Development Corp., submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:099785-E)
00064530
00065653
00252078
40901703
40953401
41085001
41089501
41143301
Breault, G.O.; Fox, S.E. (1980) Confirmation of Phosalone in Chicken Tissues by Gas
Chromatography/Mass Spectrometry. (Unpublished study received Dec 4,1980
under 359-620; prepared by Analytical Development Corp., submitted by Rhone-
Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:099785-G)
Rhone-Poulenc (1980). Lifetime Oncogenicity Study in Mice. International Research
and Development Corporation, Mattawan, MI. Report no. 347-009. 6/23/1980.
Unpublished.
Morris, JJVL (1983). Acute Delayed Neurotoxicity Study in Hens with Phosalone.
Gulf South Research Institute. GSRI Project No. 411-B51-40. 9/22/83.
Unpublished.
Seymour, R. (1988) Section A: The Names, Chemical Identity and Composition of
Phosalone Technical: Project No. 40321. Unpublished study prepared by Rhone-
Poulenc Ag. Co. 123 p.
Chabassol, Y.; Giraud, J.; Picard, C. (1988) Product Chemistry Data: Phosalone:
Analysis and Certification of Product Ingredients: Study No. 88-15. Unpublished
compilation of Rhone-Poulenc. 163 p.
Allen, PA.; et al (1989). Embryotoxicity Study (Including Teratogenicity) with
Phosalone Technical in the Rat. Research and Consulting Company and RCC
Umweltchemie, Itingen, Switzerland. Project Number 082980. March 21,1989.
Allen, PA.; et al (1989). Embryotoxicity Study (Including Teratogenicity) with
Phosalone Technical in the Rabbit Research and Consulting Company AG,
Switzerland. Study Number 083002. April 21,1989.' Unpublished.
Murli, H. (1989). Mutagenicity Test on Phosalone Technical la an In Vitro
Cytogenetic Assay Measuring Chromosomal Aberration Frequencies in Chinese
Hamster Ovary (CHO) Cells. Hazelton Laboratories, America, Inc., Kensington, MD;
study Completion Date: September 6,1989. (Unpublished).
20
-------
BIBLIOGRAPHY
MRID
CITATION
44792005 Brown, E. (1999) Phosalone Technical Manufacturing Data from Voltas, Ltd: Quality
Control Data from 10 Consecutive Batches: Description of the Manufacturing Process:
Lab Project Number: RPA/AI/586PHOS:P-513-09-96;RD/CRLD?AN?9715286.
Unpublished study prepared by Rhone-Poulenc Ag Company. 166 p.
44792007 Cousin,, J. (1995) Phosalone Active Ingredients Octanol/Water Partition Coefficient:
Lab Project Number: 94-161: RD/CRLD/AN/9515083. Unpublished study prepared
by Rhone-Poulenc. 16 p.
44792008 Barker, M. (1992) Phosalone Dietary Toxicity Study in Beagle Dogs. Huntingdon Life
Science. Ltd., Cambridgeshire, England. HLS Project Identity: KNP 336, January 31,
1992; amended final report date February 22,1999. Unpublished.
44792009 Urtizberea, M. (1999) Concentrations in Diet of One-year Chronic Toxicity Study in
Dog (RNP 336). Rhone-Poulenc Secteur Agro, Lyon, France. Report Number
MU/NC:93/182-TOX. February 16,1999. Unpublished.
44792013 Brooker, A.J. (1999). A Study of the Effects of Phosaloneon Reproductive Function
of Two Generations in the Rat. Huntingdon Research Centre Ltd. HLS Project
Identity RNP 326; HRC report No. RNP 326/91277. March 22,1999. [original
report dated November 26,1991]. Unpublished.
44792015 Haworth, L. and Lawlor, T.E. (1989). Mutagenicity test on Phosalone Technical in the
Ames Salmonella/Microsome Reverse Mutation Assay; Hazelton Laboratories
America, Inc. Kensington, MD; HLA Study No. 10754-0-401; Study Completion
Date: September 6,1989. Unpublished.
44792016 Cifone, M.A. (1989). Phosalone Technical in the Rat Primary Hepatocyte
Unscheduled DNA Synthesis Assay; Hazelton Laboratories America, Inc. Kensington,
MD; HLA Study No. 10754-0-447; Study Completion Date: July 7,1989;
Amendment dated March 10,1999. (Unpublished).
44792017 Hopkins, R. (1999). (14C)-Phosalone: A Study of the Absorption, Distribution,
Metabolism and Excretion in the Rat. Covance (U.K.). Study Report No. 5759-
68/93. February 12,1999. Unpublished.
21
-------
BIBLIOGRAPHY
MRID
CITATION
44792018
44792019
44792020
44792021
44792022
44792023
44792024
44792025
Toia, R.; Kimmel, E.; Periasamy? R. (1995) A Metabolism Study with (carbon-14)-
Phosalone on Grapes: Lab Project Number: 385W-1:358W: EC-92-218.
Unpublished study prepared by PTRL West, Inc. 309 p.
Ewing, A.; Kimmel, E.; Ruzo, L. (1999) A Metabolism Study with (carbon-14)-
Phosalone on Apples (Pyrus malus): Final Report: Lab Project Number: 181-W:
181W. UnpubHshed study prepared by PTRL West, Inc. 89 p.
Gabereau, M. (1997) Phosalone: Analytical Method for the Determination of Residues
in Plants: Lab Project Number: AR 148-97: 97-95-18: 97-95. Unpublished study
prepared by Rhone-Poulenc. 40 p. { OPPT 860.1340}
Yslan, E; Bourgade, C. (1998) Phosalone: Confirmatory Method for the
Determination of Residues in Plants: Lab Project Number: 97-189:
RD/CRLD/AN/9815432: AR 159-97. Unpublished study prepared by Rhone-
Poulenc. 25 p. {OPPTS 860.1340}
Quintelas, G. (1998) Stability Study of Phosalone in Fruits after Storage in a Freezer at
a Temperature Near-18 degrees Celsius: Lab Project Number: 98-162: RPA/98-072.
Unpublished study prepared by Rhone-Poulenc. 26 p. {OPPTS 860.1380}
Muller, M. (1999) Phosalone: Formulation: Zolone 25L (EC) Test in Italy, 1989
Residues in Apples: Final Report: Lab Project Number: 89556:
AG/CRLD/AN/8916827. UnpubHshed study prepared by Rhone-Poulenc 23 p
{OPPTS 860.1500}
Muller, M (1999) Phosalone: Formulation: Zolone 25L (EC) Tests in Italy, 1989
Residues in Leaves and Fruit of Apples: Lab Project Number:
AG/CRLD/AN/9015907. Unpublished study prepared by Rhone-Poulenc. 21 p
{OPPTS 860.1500}
Maestracci, M. (1997) Phosalone: Formulation EXP0553 ID (EC) Trial France 1996
Residues in Apple Decline Study (Reverse Curve): Lab Project Number: 96-775:
RD/CRLD/ANDBE9716155. Unpublished study prepared by Rhone-Poulenc 63 p
{OPPTS 860.1500}
22
-------
BIBLIOGRAPHY
MRID
CITATION
44792026 Maestracci, M. (1997) Phosalone: Formulation EXP0553 ID (EC) Trial France 1996
Residues in Apple Decline Study: Lab Project Number: 96-776:
RD/CRLD/ANVT9716613. Unpublished study prepared by Rhone-Poulenc. 60 p.
{OPPTS 860.1500}
44792027 Maestracci, M. (1998) Phosalone: Formulation EXP0553 ID (EC) Trials France 1997
Residues in Apple: Lab Project Number: 97-602: RD/CRLD/AN/VT9815382.
Unpublished study prepared by Rhone-Poulenc. 50 p. {OPPTS 860.1500}
44792028 Maestracci, M. (1998) Phosalone: Formulation EXP0553 ID (EC) Trials France 1997
Residues in Apple: Reverse Curve: Lab Project Number: 97-601:
RD/CRLD/ANDBE9815324. Unpublished study prepared by Rhone-Poulenc. 66 p.
{OPPTS 860.1500}
44792029 Maestracci, M. (1998) Phosalone: Formulation EXP60308B (WP) Trial Spain 1997
Residues in Pear: Reverse Curve: Lab Project Number: 97-702:
RD/CRLD/AN/VT9815818. Unpublished study prepared by Rhone-Poulenc. 50 p.
{OPPTS 860.1500}
44792030, Maestracci, M. (1998) Phosalone: Formulation EXP60308B (WP) Trial Italy 1997
Residues in Apple: Lab Project Number: 97-264: RD/CRLD/ANVT9815916.
Unpublished study prepared by Rhone-Poulenc. 84 p. {OPPTS 860.1500}
44792031 Maruyama, M. (1979) Phosalone: Report on Pesticide Residue Analysis: Official Trials
Apple: Lab Project Number: PHOS/JAPAN/1979/1RPA. Unpublished study
prepared by Chuo University. 21 p. {OPPTS 860.1500}
44792032 Kato, M. (1979) Phosalone: Report on Pesticide Residue Analysis: Official Trials
Apple: Lab Project Number: PHOS/JAPAN/1989/lRPA. Unpublished study
prepared by Japan Food Analysis Federation. 18 p. {OPPTS 860.1500}
44792033 Maestracci, M. (1998) Phosalone: Formulation EXP60308B (WP) Trials Germany
1997 Apple and in Pear Reverse Curve: Lab Project Number: 97-767: RD/CRLD/
ANMSA9816476. Unpublished study prepared by Rhone-Poulenc. 117 p.
23
-------
BIBLIOGRAPHY
MRID
CITATION
44792034
44792035
44792036
44792037
44792038
44792039
44792040
44792041
Muller, M. (1999) Phosalone: Formulation: Zolone 25L (EC) Tests in Italy, 1989
Residues in Leaves and Fruit of Grapes: Lab Project Number
AG/CRLD/AN/9015907. Unpublished study prepared by Rhone-Poulenc. 22 p.
Maestracci, M. (1997) Phosalone: Formulation EXP06027B (SC) Trials France 1996
Residues in Cherry: Decline Study: Lab Project Number 96-542: RD/
CRLD/ANDBE9716189. Unpublished study prepared by Rhone-Poulenc. 81 p.
Maestracci, M. (1998) Phosalone: Formulation EXP0553 ID (EC) Trial France 1997
Residues in Peach Reverse Curve: Decline Study: Lab Project Number: 97-522:
RD/CRLD/ANDBE9815342. Unpublished study prepared by Rhone-Poulenc. 52 p
{OPPTS 860.1500}
Maestracci, M. (1998) Phosalone: Formulation EXP05531D (EC) Trial France 1997
Residues in Cherry: Decline Study: Lab Project Number: 97-554:
RD/OILD/AN/VT9815381. Unpublished study prepared by Rhone-Poulenc. 93 p.
{OPPTS 860.1500}
Maestracci, M. (1998) Phosalone: Formulation EXP05531D (EC) Trial France 1997
Residues in Peach: Lab Project Number: 97-523: RD/CRLD/AN/VT9815817.
Unpublished study prepared by Rhone-Poulenc. 52 p. {OPPTS 860.1500}
Maestracci, M. (1998) Phosalone: Formulation EXP60308B (WP) Trial Italy 1997
Residues in Peach: Decline Study: Lab Project Number 97-622:
RD/CRLD/ANDBE9815848. Unpublished study prepared by Rhone-Poulenc. 87 p.
{OPPTS 860.1500}
Maestracci, M. (1998) Phosalone: Formulation EXP60308B (WP) Trial Spain 1997
Residues in Peach: Lab Project Number: 97-701: RD/CRLD/ANDBE981532.
Unpublished study prepared by Rhone-Poulenc. 48 p. {OPPTS 860.1500}
Muller, M. (1995) Phosalone and oxo-Phosalone (Metabolite) Formulation EXP
06027A (SC) Trials France 1994 Residues in Almond: Lab Project Number: 94-543:
RD/CRLD/AN/BD9516513. Unpublished study prepared by Rhone-Poulenc. 56 p.
{OPPTS 860.1500}
24
-------
BIBLIOGRAPHY
MRID
CITATION
44792042 Maestracci, M. (1997) Phosalone: Fonnulation EXP0553 ID (EC) Trial France 1996
Residues in Almond: Lab Project Number: 96-528: RD/CRLD/ ANDBE9716150.
Unpublished study prepared by Rhone-Poulenc. 52 p.
44792043 Maestracci, M. (1997) Phosalone: Formulation EXP06027B (SC) Trial France 1996
Residues in Almond: Decline Study: Lab Project Number: 96-529:
RD/CRLD/ANDBE9716188. Unpublished study prepared by Rhone-Poulenc. 55 p.
{OPPTS 860.1500}
44792044 Maestracci, M. (1997) Phosalone: Formulation EXP05531D (EC) Trial France 1996
Residues in Almond: Decline Study: Lab Project Number: 96-530:
RD/CRLD/ANDBE9716168. Unpublished study prepared by Rhone-Poulenc. 55 p.
{OPPTS 860.1500}
44792045 Maestracci, M. (1997) Phosalone: Formulation EXP06Q27B (SC) 96-525:
RD/CRLD/AN/KD9716028. Unpublished study prepared by Rhone-Poulenc. 52 p.
{OPPTS 860.1500}
44792046 Maestracci, M. (1999) Phosalone: Formulation EXP06027B (SC) Residues in Apple
and Processed Products: Trial France 1996: Lab Project Number: 96-694:
RD/CRLD/ANDBE9816999. Unpublished study prepared by Rhone-Poulenc. 59 p.
{OPPTS 860.1520}
44801001 Cousin, J. (1997) Phosalone Active Ingredient Water and Solvent Solubility: Lab
Project Number: 97-09: RD/CRLD/AN/9718915. Unpublished study prepared by
Rhone-Poulenc Agro. 25p.
44801002 Barker, M. H. (1996). Phosalone: Potential Tumorigenic and Toxic Effects in
Prolonged Dietary Administration to Rats (according to OECD guidelines).
Huntingdon research Centre Ltd., England. Study No. RNP 375/930643. June 14,
1996. Unpublished.
44852501 Hughes, E.W. (1999). Single Dose Study by Oral Gavage Administration to Assess
Cholinesterase Inhibition in Rats. Huntingdon Life Sciences, Huntingdon, England.
Study No. RNP/600. May 27,1999. Unpublished.
Note: The review for MRID 44852501 was included in the review for the
acute neurotoxicity study (MRID 44852503).
25
-------
MRID
BIBLIOGRAPHY
CITATION
44852502
44852503
44852504
45013401
45013402
Hughes, E.W. (1999). Single Dose Study by Oral Gavage Administration. Dose
Range and Time to Peak Effects in Rats. Huntingdon Life Sciences, Huntingdon,
England. Study No. RNP/601. May 28,1999. Unpublished.
Note: The review for MRE) 44852502 was included in the review for the
acute neurotoxicity study (MRID 44852503).
Hughes, E.W. (1999). Phosalone Neurotoxicity Study by a Single Oral Gavage
Administration to CD Rats Followed by a 14-Day Observation Period. Huntingdon
Life Sciences, Huntingdon, England. Study No. RNP/586. June 8,1999.
Unpublished.
Hughes, E.W. (1999). Phosalone 13 week Neurotoxicity Study in Rats by Dietary
Administration. Huntingdon Life Sciences Ltd, Cambridgeshire, England. Project #
RNP/587. JuneS, 1999. Unpublished.
Cosgrove, D. (1999). Phosalone: Magnitude of Residues in Apples, Canada, 1999:
Laboratory Project No: CA99Z02R: 99RP61. REP: 99098DC. Unpublished report
prepared by Rhone-Poulenc Canada Inc. and Enviro-Test Laboratories. 139 p.
{OPPTS 860.1500}
Cosgrove, D. (1999). Phosalone: Magnitude of Residues in Cherries, Canada, 1999:
Laboratory Project No: CA99Z01R: 99RP51. REP: 99097DC. Unpublished report
prepared by Rhone-Poulenc Canada Inc. and Enviro-Test Laboratories 160 p
{OPPTS 860.1500}
United States Department of Agriculture. (USDA, 1998). 1998 Agricultural Statistics,
National Agricultural Statistics Service, Washington, DC. Dataset.
United States Department of Agriculture. (USDA, 1998). Fruit and Vegetable
Analysis. Market and Trade Economics Division. Economic Research Service.
Washington, DC. Dataset.
26
------- |