United States Prevention, Pesticides EPA738-R-00-014
Environmental Protection and Toxic Substances September 2000
Agency (7508C)
&EPA Report on FQPA
Tolerance Reassessment
Progress and Interim Risk
Management Decision
Mevinphos
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Manufacturer:
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
preliminary and revised human health risk assessment for the organophosphate pesticide mevinphos.
The public comment period on the revised risk assessment phase of the tolerance reassessment process
is closed. The enclosed "Report on FQPA Tolerance Reassessment Progress and Interim Risk
Management Decision for Mevinphos," which was approved on September 27, 2000, summarizes the
Agency's assessment of the dietary risk from mevinphos as part of the tolerance reassessment process
for this chemical, presents a summary of the related food tolerances for this single chemical, and
provides the Agency's current risk management decision based on the risk assessment. Mevinphos has
no U.S. registrations but does have fifteen 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 Mevinphos" is being published in the Federal Register. To
obtain a copy of this document, please contact the OPP Public Regulatory Docket (7502C), U.S.
EPA, Ariel Rios Building, 1200 Pennsylvania Avenue, N.W., Washington, D.C., 20460, telephone
(703) 305-5805. Electronic copies of this report and the technical documents supporting it are
available on the internet and can be found on the Agency's web page, "www.epa.gov/pesticides/op."
This document is based on the updated technical information found in the mevinphos 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 mevinphos, 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,
AMVAC Chemical Corporation, as well as comments submitted by the general public and
stakeholders during the comment period on the risk assessment. A technical briefing was not held for
mevinphos since it has no U.S. registrations, only import tolerances, and aggregate risk consists of risk
from food only.
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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 mevinphos 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 mevinphos once the cumulative assessment for all of the
organophosphates is complete.
If you have questions on this document, please contact the Chemical Review Manager, Joseph
Nevola at (703) 308-8037.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Report on FQPA Tolerance Reassessment Progress
and Interim Risk Management Decision
for
Mevinphos
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TABLE OF CONTENTS
MEVTNPHOS TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS iii
EXECUTIVE SUMMARY 1
I. INTRODUCTION 1
II. CHEMICAL OVERVIEW 3
A. Regulatory History 3
B. Chemical Identification 4
C. Use Profile 5
D. Estimated Usage of Pesticide 6
III. SUMMARY OF MEVINPHOS RISK ASSESSMENT 6
IV. FQPA TOLERANCE REASSESSMENT PROGRESS & INTERIM RISK
MANAGEMENT DECISION 11
A. Tolerance Reassessment Progress & Interim Risk Management Decision ..11
B. Summary of Phase 5 Comments 12
C. Regulatory Position 16
1. FQPA Assessment 16
a. "Risk Cup" Determination 16
b. Tolerance Summary 16
2. Endocrine Disrupter Effects 19
D. Regulatory Rationale 20
V. WHAT MANUFACTURERS NEED TO DO 20
A. Additional Data Requirements 20
B. Risk Mitigation Requirements 21
VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM 21
APPENDIX A: BIBLIOGRAPHY 23
APPENDIX B: LIST OF AVAILABLE RELATED DOCUMENTS 31
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MEVINPHOS TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
William Hazel
Christine Olinger
Felecia Fort
Virginia Dobozy
Use and Usage Analysis
David Widawsky
Risk Management
Joseph Nevola
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE 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 USD A Continuing Surveys for Food Intake by Individuals
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES 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
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
HOT 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/1, mg/kg or
ppm.
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
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
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
PRZM7
EXAMS Tier H Surface Water Computer Model
Q !* 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
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
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
Mg/g Mcrograms Per Gram
//g/L Mcrograms Per Liter
USD A United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
VI
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EXECUTIVE SUMMARY
EPA has completed its review of public comments on the revised risk assessment for
mevinphos, and is, in this document, issuing its interim decision on tolerance reassessment and risk
mitigation for this chemical. The revised risk assessment is based on review of the required target data
base supporting the mevinphos import tolerances and information received during the public comment
periods in the pilot process developed through the Tolerance Reassessment Advisory Committee
(TRAC). Mevinphos is not registered under FIFRA and may not be sold, distributed, or used in the
U.S. In 1995 EPA reached an agreement with AMVAC Chemical Corporation to cancel all
registrations of mevinphos because of agricultural worker exposure and safety concerns. Subsequently,
most of the mevinphos tolerances were revoked, except for fifteen tolerances which were maintained
for import purposes. EPA's revised risk assessment for mevinphos indicates that the dietary risk does
not exceed the Agency's level of concern; therefore, no risk mitigation is necessary at this time.
Tolerances exist for mevinphos use in/on broccoli, cabbage, cauliflower, celery, cucumbers, grapes,
lettuce, melons, peas, peppers, spinach, summer squash, strawberries, tomatoes, and watermelon.
The final tolerance reassessment decision for mevinphos will be issued once the cumulative
assessment for all of the organophosphates is completed. The Agency may need to issue risk
management measures for mevinphos at the time the organophosphate cumulative assessment is
finalized.
I. INTRODUCTION
This report on the progress toward tolerance reassessment of mevinphos 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. Mevinphos is subject
only to FQPA tolerance reassessment because it is not registered in the U.S.; but it does have import
tolerances. However, some history and background of FIFRA is included here for informational
purposes and to provide a discussion of the existing laws requiring action on pesticides.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
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On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require EPA review of all tolerances in effect when FQPA was enacted.
FQPA amends both FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA), but does not
amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its reregistration
program while it resolves the remaining issues associated with the implementation of FQPA. The
Agency is also continuing its progress toward tolerance reassessment as required by FQPA for all of
the organophosphate chemicals, whether or not they are subject to the reregistration process. 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. Although not subject to the reregistration process, the individual dietary assessment for the
organophosphate mevinphos has been completed. Since mevinphos shares a common mode of activity
with other organophosphates, a cumulative risk assessment must be conducted prior to determining
whether the safety requirements of FQPA have been satisfied.
Mevinphos is not registered for use in the United States; however, there are fifteen import
tolerances for this chemical; i.e., tolerances for broccoli, cabbage, cauliflower, celery, cucumbers,
grapes, lettuce, melons, peas, peppers, spinach, summer squash, strawberries, tomatoes, and
watermelon. Because it is not registered in the U.S., it is not subject to the reregistration process.
However, it is subject to the requirements of FQPA tolerance reassessment; therefore, a dietary risk
assessment was completed. This document presents the Agency's dietary risk assessment for
mevinphos, as part of the tolerance reassessment process. 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
mevinphos 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 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 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
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• 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
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 m gives an overview of the dietary risk assessment for mevinphos, 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), and in the Public Docket.
II. CHEMICAL OVERVIEW
A. Regulatory History
Mevinphos is a contact/systemic insecticide-acaricide. It is not registered under FIFRA and
may not be sold, distributed, or used in the United States. However, fifteen tolerances remain for
residues of mevinphos on the following commodities; at 1.0 ppm in/on broccoli, cabbage, cauliflower,
celery, spinach, and strawberries; at 0.5 ppm in/on grapes, lettuce, melons, and watermelon; at 0.25
ppm in/on peas, peppers, and summer squash; and at 0.2 ppm in/on cucumbers and tomatoes (40 CFR
§180.157). Since there are currently no domestic registrations for mevinphos, these tolerances serve
as "import tolerances." Data have been or currently are being developed to determine whether these
tolerances need to be modified.
Mevinphos is a List A reregistration chemical and was the subject of a Registration Standard,
dated March 31, 1988, which presented the regulatory decisions on the available data and specified
additional data required for reregistration purposes. Due to concerns over agricultural worker
exposure and safely, EPA was prepared on June 30, 1994 to issue a Notice of Intent to Suspend all
mevinphos registrations. Instead, AMVAC requested voluntary cancellation of all its U.S. registrations
for products containing mevinphos. The Agency granted this request and all U.S. registrations for
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mevinphos were canceled effective July 1, 1994 (59 FR 38973, August 1, 1994); this cancellation
order was later amended (60 FR 17357, April 5, 1995) to extend the distribution, sale, and use of
AMVAC's mevinphos-containing products to November 30, 1995. The Agency subsequently
proposed to revoke all mevinphos tolerances (60 FR 39302, August 2, 1995). In its proposal, the
Agency also noted that a preliminary acute dietary risk assessment based upon the available data
indicated a concern for acute exposure to mevinphos, particularly for infants and children. In response
to this proposal, AMVAC requested (letter dated October 31, 1995) that the Agency not revoke 13
tolerances for mevinphos residues in/on selected fruits and vegetables as AMVAC was supporting the
continued use of mevinphos in Mexico on commodities that are imported into the U.S. AMVAC also
provided (letter dated November 20, 1995) its own acute dietary exposure analysis for mevinphos
residues based upon the crop uses they were continuing to support. AMVAC revised its commitment
on June 7, 1996 to include cauliflower as an import tolerance, and on July 6, 1999 to maintain the
watermelon tolerance in combination with melons. With the exception of those 15 tolerances which
AMVAC agreed to support for import purposes, the Agency revoked all other mevinphos tolerances
effective November 1, 1999 (64 FR 41818, August 2, 1999).
A preliminary human health risk assessment for mevinphos, dated October 19, 1999, was
followed by a revised human health risk assessment, dated May 17, 2000, as part of the tolerance
reassessment process.
B.
Chemical Identification
alpha-Mevinphos
MeO
MeO
C02CH3
/ i
H
o
beta-Mevinphos
C02CH3
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
Mevinphos
methyl 3-
[(dimethoxyphosphinyl)oxy]butenoate,
alpha and beta isomers
Organophosphate
7786-34-7
OPP Chemical Code:
015801
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! Empirical Formula: C7H13O6P
! Molecular Weight: 22416
! Trade and Other Names: Phosdrin
! Basic Manufacturers: AMVAC Chemical Corporation
A detailed discussion on the physical properties of mevinphos can be found in the EPA
document entitled "Mevinphos: Revised Human Health Risk Assessment," dated May 17, 2000.
C. Use Profile
The following information is based on the current uses of mevinphos outside of the United
States, and includes an overview of use sites and application methods.
Type of Pesticide: Insecticide-acaricide.
Summary of Use Sites: Mevinphos is registered outside the U.S. for use in/on
broccoli, cabbage, cauliflower, celery, cucumbers,
grapes, lettuce, melons, peas, peppers, spinach,
summer squash, strawberries, tomatoes, and
watermelon. Mevinphos is not registered under FIFRA
and may not be sold, distributed, or used in the U.S.
Target Pests: Insects
Formulation Types: Emulsion concentrate and Liquid concentrate.
Method and Rates of Application:
Method and Rate - Maximum use rate range 220 g ai/ha (0.2 Ib ai/A) to
440 g ai/ha (0.39 Ib ai/A), at Pffls ranging from 3 to 10
days.
Timing - Single broadcast application per crop season.
Use Classification: Not registered for use in the U.S.
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D. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of mevinphos. 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.
Mevinphos is used to control insects that attack fruit and vegetable plants. Mexico is a major
source of commodities treated with mevinphos that are imported into the United States. Based on the
Mexican field trial data, a single broadcast application of mevinphos can be applied per crop season
ranging from 220 g ai/ha (0.2 Ib ai/A) to 440 g ai/ha (0.39 Ib ai/A), and at PHIs ranging from 3 days to
10 days. As no Mexican field trials were conducted on head lettuce, EPA assumed the maximum use
rate is 440 g ai/ha (0.39 Ib ai/A).
Monitoring data indicate that residues of mevinphos in fruits and vegetables are significantly
lower than the established tolerances. Residues were typically below the limit of detection (LOD),
between the LOD and the limit of quantitation (LOQ), or at or just above the LOQ.
III. SUMMARY OF MEVINPHOS RISK ASSESSMENT
The following is a summary of EPA's revised human health risk findings and conclusions for the
organophosphate pesticide mevinphos, as fully presented in the revised risk assessment document,
"Mevinphos: Revised Human Health Risk Assesment," dated May 17, 2000. The risk assessment
presented here forms the basis of the Agency's interim risk management decision for mevinphos only;
the Agency must complete a cumulative assessment of the risks of all organophosphate pesticides
before it can complete its reassessment of the mevinphos tolerances.
Because mevinphos 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.
Human Health Risk Assessment
The Human Health Risk assessment incorporates the salient portions of the following Tolerance
reassessment process chapters as well as several memoranda and Agency committee reports: the
Toxicology Chapter prepared by V. Dobozy (August 16, 1999; D251794), the Residue Chemistry
Chapter prepared by W. Hazel (October 19, 1999; D259802), the anticipated residue/dietary risk
memorandum by C. Olinger and F. Fort (October 18, 1999; D259803), the Hazard Identification
Assessment Review Committee report by V. Dobozy and B. Tarplee dated April 13, 1999, and the
FQPA Safety Factor Committee report by B. Tarplee dated September 28, 1999.
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Dietary Risk from Food
Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that while the
mevinphos data base is not complete, there are sufficient data from the available studies for selecting
acute and chronic dietary endpoints for an import tolerance. Further details on the toxicity of
mevinphos can be found in the May 17, 2000 Revised Risk Assessment. A brief overview of the
studies used for the dietary risk assessment is outlined in Table 1 of this document.
FQPA Safety Factor
In the case of acute risk assessments, the FQPA safety factor for all population subgroups
other than infants, children, and females of child-bearing age (13+ years), was removed (reduced to
IX). Acute aggregate risk consists solely of food sources of dietary exposure to mevinphos and since
the acute dietary exposure assessment was highly refined, the Agency does not think that acute dietary
exposure is underestimated.
The FQPA safety factor for acute assessments was reduced to 3X for infants, children, and
females of child-bearing age (13+ years). When assessing Acute Dietary Risk to Females 13-50 and
to the Infants and Children Subgroups, the Safety Factor can be reduced to 3X since no increased
susceptibility was observed following in utero exposure to rats or rabbits in the developmental studies
(which could potentially occur after a single dose); and the concern for this exposure scenario is the
uncertainty associated with the data gap for the developmental neurotoxicity study. The developmental
neurotoxicity study is designed to evaluate neurotoxic effects on the mother and fetus from the time of
implantation of the fertilized egg into the wall of the uterus through birth. This study may provide
additional information on possible adverse effects of mevinphos on the developing organism.
In the case of chronic risk assessments, the FQPA Safety Factor could not be removed. It is
10X for all population subgroups since there is concern for increased susceptibility of the young
demonstrated after repeated oral exposures in the range-finding study for the 2-generation reproduction
study (which is designed to assess the effects of the pesticide on male and female reproductive
processes, from egg and sperm production and mating through pregnancy, birth, nursing, growth and
development, and maturation); and since there are data gaps in the toxicology data base for the
subchronic neurotoxicity study in rats and the developmental neurotoxicity study in rats.
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). In the case of mevinphos, for infants, children, and females (13+ years), the
7
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acute Population Adjusted Dose (aPAD) level is 0.0003 mg/kg/day (acute RfD level of 0.001
mg/kg/day divided by the FQPA Safety Factor of 3X); for all other subpopulations, the aPAD is 0.001
mg/kg/day (acute RfD level of 0.001 mg/kg/day divided by the FQPA Safety Factor of IX). The
chronic Population Adjusted Dose (cPAD) level is 0.000025 mg/kg/day for all population subgroups
(chronic RfD level of 0.00025 mg/kg/day divided by the FQPA Safety Factor of 10X). A risk estimate
that is less than 100% of the acute or chronic PAD does not exceed the Agency's risk concern.
Exposure Assumptions
The acute and chronic dietary risk assessments for mevinphos were quite refined, and included
the use of monitoring data as the source of anticipated residues, correction for percent commodity
imported and percent commodity treated, and a probabilistic acute assessment.
The mevinphos dietary exposure analyses were based largely on USDA/PDP (grapes and
tomatoes) and FDA monitoring data (all other crops except head lettuce and cabbage). Only
monitoring data from imported commodities were used for these dietary exposure assessments. Field
trial data were used in the cases of head lettuce (U.S. field trial data) and cabbage (Mexican field trial
data). Available field trial and monitoring data included all residues of regulatory and lexicological
concern, i.e., the alpha- and beta-isomers of mevinphos.
Both acute and chronic dietary exposure assessments included correction for percent of crop
imported and percent crop treated figures provided by OPP's Biological and Economic Analysis
Division (BEAD; August 10, 1999 and September 27, 1999 D. Widawsky reports, see D259803,
Attachment 1). Residues were typically below the limit of detection (LOD), between the LOD and the
limit of quantitation (LOQ), or at or just above the LOQ. The monitoring data indicate that residues of
mevinphos in fruits and vegetables are significantly lower than the established tolerances.
As grape and tomato processing studies were not available, default concentration factors were
used in the dietary exposure assessments; submission of such studies would permit further risk
refinement.
The chronic and acute analyses do not take into consideration the potential for reduction of
mevinphos residues in cooked/canned/processed products since there are no chemical-specific cooking
studies. The Agency will refine the mevinphos dietary exposure analyses if such data become available.
Dietary risk analyses for mevinphos were conducted with the Dietary Exposure Evaluation
Model (DEEM™). DEEM incorporates consumption data generated in USDA's Continuing Surveys
of Food Intakes by Individuals (CSFH), 1989-1992.
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Table 1. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary
Risk Assessment of Mevinphos.
Assessment
Acute Dietary
Chronic
Dietary
Study
acute
neurotoxicity
study in rats
(MRID
42985401)
combined
chronic toxicity/
carcinogenicity
study in rats
(MRID
43088601)
Dose
NOAEL=
0.1
mg/kg/day
NOAEL=
0.025
mg/kg/day
End point
Plasma and
brain ChE
inhibition
Plasma and
brain ChE
inhibition
UF
100
100
FQPA
Safety
Factor
IX
3X
10X
PAD
0.001
mg/kg/
day
(gen. pop.)
0.0003
mg/kg/
day
(females
13+
infants,
children)
0.000025
mg/kg/
day
Acute Food Risk
Acute dietary risk is calculated considering what is eaten in one day and maximum, or high-end
residue values in food. The toxicity endpoint is the inhibition of plasma and brain cholinesterase
observed in an acute neurotoxicity study in rats (NOAEL= 0.1 mg/kg/day). The FQPA 10X Safety
Factor was reduced to 3X for infants, children, and females of child-bearing age (13+ years) since no
increased susceptibility was observed following in uteroexposure to rats or rabbits in the developmental
studies, and the concern for this exposure scenario is the uncertainty associated with the data gap for
the developmental neurotoxicity study. For all other subpopulations, the FQPA Safety factor was
removed (reduced to IX).
A risk estimate that is less than 100% of the acute Population Adjusted Dose (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. In the acute dietary assessment for
mevinphos, risk at the 99.9th percentile of exposure is reported since the probabilistic (Monte Carlo)
analysis was highly refined using residue distribution files adjusted by the proportion of U.S.
-------
consumption of each food that has been treated. At the 99.9th percentile of exposure, the most highly
exposed population subgroup is children (1-6 years), with 17% of the aPAD consumed. Estimated
acute dietary exposure to the general U.S. population is much lower, corresponding to 2% aPAD.
Therefore, estimated acute dietary exposure and risk are below the Agency's level of concern for
mevinphos; i.e., less than 100% of the aPAD is utilized.
The acute dietary assessment is very highly refined. However, the acute analysis does not take
into consideration the potential for reduction of mevinphos residues in cooked/ canned/processed
products since there are no chemical-specific cooking studies. Additional refinements could include
the conduct of grape and tomato processing studies to derive mevinphos-specific processing factors.
(Import tolerances may be needed for mevinphos residues in/on grape and tomato processed
commodities if residues are concentrated upon processing, and if they are likely to be processed in the
U.S., or if their processed commodities are imported from Mexico. Alternatively, the manufacturer
may provide data indicating that mevinphos treated grapes and tomatoes are unlikely to be used for
processing in either Mexico or the U.S.).
Chronic Food Risk
Chronic dietary risk is calculated by using the average consumption values for food and average
residue values for those foods over a 70-year lifetime. The lexicological endpoint is plasma and brain
cholinesterase inhibition, established in a 2-year oral rat study (NOAEL = 0.025 mg/kg/day). The
FQPA 10X Safety Factor was retained for all population subgroups since there is a concern for
increased susceptibility of the young, and since there are data gaps in the lexicological data base.
A risk estimate that is less than 100% of the chronic Population Adjusted Dose (cPAD) (the
dose at which an individual could be exposed over the course of a lifetime and no adverse health effects
would be expected) does not exceed the Agency's risk concern. Estimated chronic dietary exposure
and risk for mevinphos are significantly below the Agency's level of concern. The most highly exposed
population subgroup is children (1-6 years), with an estimated exposure corresponding to 1.7% of the
cPAD. Estimated dietary exposure to the general U.S. population is even lower, corresponding to
0.8% cPAD.
The risk assessment for mevinphos was conducted using highly refined anticipated residues
(PDF and FDA monitoring data, except for lettuce and cabbage where field trial data were used) and
percent of crop imported and percent crop treated figures. The chronic dietary analysis could be
refined with chemical-specific cooking studies and conduct of grape and tomato processing studies to
derive mevinphos-specific processing factors.
10
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Substantive Revision To Preliminary Risk Assessment
During the error-only comment period of Phase 1 on the mevinphos preliminary risk
assessment, AMVAC Chemical Corporation, the manufacturer, submitted substantive comments in
addition to the technical corrections that were requested by EPA in that phase. AMVAC questioned
the need to submit a developmental neurotoxicity study, additional field trial data requirements, including
field trial data for grapes in countries where AMVAC stated that it does not currently market
mevinphos, and studies to satisfy the 1991 mutagenicity test guidelines.
The Agency believes that the range-finding study associated with the two-generation rat
reproduction study showed clinical signs of toxicity and increased acute lethality in offspring, and
mevinphos is neurotoxic in mammals; therefore, a developmental neurotoxicity study is necessary.
Additional field trials are necessary to permit mevinphos tolerance reassessment. The Agency
also requires use directions that will appear on the Mexican label(s). A different formulation was used
in the Mexican field trials than were used in the trials conducted in the U.S., in many cases residues
resulting from the trials conducted in the U.S. were higher than those conducted in Mexico, and
parameters of the field trials do not agree with the current Mexican label. Also, samples of grapes from
Chile were identified through the PDF monitoring program as having detectable residues of mevinphos
(1994-1995). However, PDF shows no residues of mevinphos were detected in/on grapes (1996).
Grapes were not sampled in 1997 or 1998, but no residues of mevinphos were detected in grape juice
(1998). Consistent with the Import Tolerance Guidance (65 FR 35069, June 1, 2000), the Agency
believes that additional field trial data for grapes in countries where mevinphos is used in/on grapes are
necessary.
The Agency agrees that, in the case of mevinphos, nothing would be gained from pursuing
genetic toxicology testing in light of the negative response for a carcinogenic effect and the absence of
reproductive effects that would suggest a heritable concern. The requirement to submit fully acceptable
studies to satisfy the 1991 mutagenicity test guidelines is, therefore, waived for mevinphos. This was
the only substantive revision to the risk assessment.
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 mevinphos 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 mevinphos,
EPA has sufficient information on the human health effects of mevinphos to make some interim
11
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decisions as part of the tolerance reassessment process under FFDCA, as amended by 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 mevinphos alone in order to
determine whether any risk reduction measures are necessary to allow the continued importation of
broccoli, cabbage, cauliflower, celery, cucumbers, grapes, lettuce, melons, peas, peppers, spinach,
summer squash, strawberries, tomatoes, and watermelon containing this chemical, pending completion
of the cumulative assessment.
As a result of its assessment, EPA has determined that dietary risk from exposure to mevinphos
is not a concern for the Agency. Therefore, no risk mitigation is necessary and no further actions are
warranted at this time. The Agency may determine that 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 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
mevinphos food residue import tolerances as called for by the FQPA. When the Agency has
completed the cumulative assessment, the mevinphos tolerances will be reassessed in that light. At that
time, the Agency will reassess mevinphos 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 fmalization of the FQPA assessment for mevinphos, 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 mevinphos to the public on June 30, 2000 (65 FR
40631) and provided a 60 day comment period for interested parties to submit information, including
risk mitigation suggestions or proposals. Three comments were received during the comment period.
Comment. A private citizen disagreed with retention of mevinphos import tolerances in view of a 17%
acute Population Adjusted Dose (aPAD) for the highest risk group and in view of cumulative
organophosphate risks. Also, the commenter claimed that EPA's regulations will be less stringent than
the international standards of Codex. In addition, the commenter claimed that in R.E.D. Facts,
12
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Mevinphos, September 1994, EPA identified dietary risks as a concern in canceling mevinphos
registrations and that retention of import tolerances appears to be inconsistent with dietary risks and
FFDCA section 408(1)(2) on tolerance revocation.
Response. In response to the commenter's concern that EPA is retaining the mevinphos import
tolerances despite the fact that the Agency has not yet conducted the cumulative risk assessment, it
should be noted that the tolerance decision presented in this document for mevinphos is only an interim
decision. EPA will conduct a cumulative risk assessment of all organophosphates (OPs). Further
changes to the mevinphos tolerances could be required as necessary as a result of that cumulative
assessment for OPs.
In response to the commenter's assertion that the mevinphos tolerances are not as stringent as
the Codex MRLs, Codex currently shares the same tolerance levels on 6 crops for mevinphos, while
U.S. tolerance levels are currently higher than Codex on only 3 crops for mevinphos; i.e., melons
(except watermelon), peas, and spinach. There is no determination for the tolerances on peas and
spinach at this time. The interim tolerance decision for melons of 0.1 ppm is based on field trial data
and the Agency has made the determination that the 0.1 ppm tolerance level is safe. For one crop,
cucumbers, EPA's interim decision is to lower the tolerance from 0.2 ppm, the Codex level, to 0.05
ppm based on field trial data.
In regard to the final point, the primary reason behind the 1994 cancellation actions for
mevinphos was risk concern for agricultural workers (59 FR 38973, August 1, 1994; R.E.D. Facts,
Mevinphos, September 1994). The commenter is correct that in its proposal of August 2, 1995 (60
FR 39302), the Agency noted that a preliminary acute dietary risk assessment for mevinphos, based on
available data at the time, indicated a concern for acute exposure to mevinphos, particularly for infants
and children. However, EPA also noted that it recognized that the dietary risk concern may be
diminished if interested parties were to submit adequate exposure and/or toxicity data. (This
recognition also appears as follows: "If better data are submitted to the Agency, the Agency would
reassess risk," as noted in R.E.D. Facts, Mevinphos, September 1994, p. 3). Currently, there are
sufficient data from available studies for selecting acute and chronic dietary endpoints for an import
tolerance. The Agency's assessments of acute dietary risk and chronic dietary risk are considered to
be highly refined. Both estimated acute dietary exposure and risk (17% aPAD) and chronic dietary
exposure and risk (1.7% cPAD) are below EPA's level of concern for mevinphos.
Comment. The California Desert Grape Administrative Committee (CDGAC) stated that U.S.
imports from countries other than Mexico which use mevinphos should be included in the risk
assessment. Also, the CDGAC believes that EPA used an incorrect production figure for 1996 and an
incorrect 1995-1996 average U.S. grape production level because of a misplaced decimal point. The
CDGAC also expressed concern about temporal differences in the U.S. consumption of imported
grapes on exposure.
13
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Response. EPA agrees that grape imports from countries other than Mexico should be included in the
risk assessment. In "Mevinphos: Dietary Exposure and Risk Analyses ...," the second page of
Attachment 1 shows an updated estimate which includes grapes imported from Chile. EPA has made a
determination based on available data that the current tolerance level remains safe. However, there is
no interim tolerance level set for grapes.
The commenter is correct that a decimal "typographical error" appears in "Mevinphos: Dietary
Exposure and Risk Analyses ...," Attachment 1 incorrectly shows the 1996 U.S. production of grapes
(537.062 should be 537,062) and 1995-1996 average U.S. production level (320963.531 should be
589,226). However, the second page of Attachment 1 shows an updated estimate of grape
production. It was this correct production level that was used in the risk assessment.
The temporal differences in U.S. consumption of imports has been indirectly considered in the
probabilistic analysis. The Agency conducts dietary risk assessments using the Dietary Exposure
Evaluation Model, which incorporates consumption data generated in USDA's Continuing Surveys of
Food Intakes by Individuals (CSFII), 1989-1992. Surveys are conducted annually during the four
different seasons across the country. For chronic dietary risk assessments, the three-day average of
consumption for each subpopulation is combined with average residues in commodities to determine
average exposure. For acute dietary risk assessments, the entire distribution of consumption events for
individuals is multiplied by a distribution of residues to obtain a distribution of exposures; this is a
probabilistic analysis known as "Monte Carlo," with risk at the 99.9th percentile of exposure reported.
The Agency believes that it is not underestimating U.S. exposure.
Comment. The manufacturer, AMVAC Chemical Corporation, requests that it not be required to
submit a subchronic neurotoxicity study and a developmental neurotoxicity study. AMVAC believes
that no additional field trials are necessary under EPA's import tolerance guidance (65 FR 35069, June
1, 2000) on the basis that crops imported from all countries where mevinphos is registered is lower
than 5% of U.S. consumption (35076 p.). Further, AMVAC believes that it has already complied with
requirements for field trials in Mexico. AMVAC questions the need basis for additional field trials for
grapes in those countries where AMVAC claims mevinphos is not registered or sold. In addition,
AMVAC questions the need for the 10X safety factor in chronic dietary risk. AMVAC notes that it
has submitted storage stability data and grape processing data. AMVAC believes that there is no need
to conduct a tomato processing study, and notes that it has submitted a waiver request for tomato
processing data. AMVAC does state that it will revise the Mexican label to agree with the parameters
in the submitted Mexican field trial data.
Response. AMVAC has already submitted "A Subchronic (13 week) Neurotoxicity Study of
Mevinphos in Rats," MRID45099101. The developmental neurotoxicity study, field trial studies, and
Mexican label revisions are necessary for tolerance reassessment (see this document Part V, section A
on data requirements). The Agency believes the developmental neurotoxicity study is necessary
because there was some indication of increased sensitivity of offspring treated postnatally in the range-
14
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finding study associated with the two-generation rat reproduction study; i.e., the range-finding study
showed clinical signs of toxicity and increased acute lethality in offspring. Additionally, mevinphos is
neurotoxic in mammals. Therefore, EPA will begin the process of requiring that data in an upcoming
Federal Register Notice. AMVAC can make any further arguments about the necessity of that study in
the context of that data call-in process.
On the import guidance, the commenter is incorrectly asserting that they are exempt from field
trial requirements because the crop imports from all countries were less than 5% of U.S. consumption.
The guidance does not refer to a "consumption" level but actually refers to an "imported" level. The
Import Tolerance Guidance of June 1, 2000 states that field trials will generally need to be conducted in
all countries that export at least 5% of the total amount of a specific commodity "imported" into the
U.S. (35076 p.). Therefore, the field trial data requirements are in accordance with the Import
Tolerance Guidance.
Additional field trials are needed from Mexico because tolerances may not be set higher than
necessary, which may occur using the existing database. Current monitoring data suggest that lower
tolerances will likely be appropriate in many cases.
EPA believes that it is necessary to conduct field trials for grapes and that the trials need to be
representative of all countries where mevinphos is registered or used on grapes. This is necessary
because a tolerance is not country-specific. Once the tolerance level is set, the tolerance will apply to
all countries from which grapes are imported into the U.S. If it can be demonstrated that for a
particular country mevinphos is not registered or used on grapes, and the Agency also has no
information showing that mevinphos is registered or used on grapes in that country, then EPA will not
require field trials for grapes in that country.
Regarding the need basis for the 10X safety factor in chronic dietary risk, the Agency believes
that the 10X FQPA safety factor could not be removed due to concern for increased susceptibility of
the young in the range-finding study for the 2-generation reproduction study; and due to data gaps in
the lexicological database.
Storage stability data, grape processing data, and a waiver request for tomato processing data
have been received by the Agency and are in review. The Agency is still waiting for the revised
Mexican labels to be submitted. These labels are needed because the parameters of the field trial data
which have been submitted do not agree with current Mexican labels.
15
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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 mevinphos is within its own "risk cup." In other
words, if mevinphos did not share a common mechanism of toxicity with other chemicals, EPA would
be able to conclude today that the import tolerances for mevinphos on broccoli, cabbage, cauliflower,
celery, cucumbers, grapes, lettuce, melons, peas, peppers, spinach, summer squash, strawberries,
tomatoes, and watermelon meet the FQPA safety standards. In reaching this determination, 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 mevinphos, because there
are no domestic uses; i.e., there is no U.S. residential or drinking water exposure. But, results of the
acute and chronic food assessments indicate that exposures are within acceptable levels; that is, risk
from exposure to mevinphos "fits" within the individual risk cup. Therefore, although additional storage
stability data are required to support the cucumber and melon field trial data and provided that revised
Mexican label directions agree with field trial parameters, available data indicate the import tolerances
for cucumbers and melons should be lowered to 0.05 ppm and to 0.1 ppm, respectively. With the
exception of the tolerance for watermelon, which should be reassigned since it is covered by melons, an
interim tolerance decision for the other existing tolerances cannot be determined because additional
data are required and should remain in effect at their existing tolerance levels. Tolerances may be
reassessed only upon completion of the cumulative risk assessment of all organophosphates.
b. Tolerance Summary
The established tolerances for residues of mevinphos in/on plant commodities are currently
expressed in terms of residues of mevinphos per se (methyl 3-[(dimethoxyphosphinyl)oxy]butenoate,
alpha and beta isomers) [40 CFR § 180.157]. It should be noted, however, that the preferred
chemical name for mevinphos is methyl 3-[(dimethoxyphosphinyl)oxy]butenoate.
Mevinphos residues of concern in plants include the alpha- and beta-isomers of mevinphos.
Based upon the available animal metabolism data, quantifiable residues of mevinphos are unlikely to
occur in livestock [40 CFR § 180.6(a)(3)]; therefore, tolerances in animal commodities are not
16
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required. Tolerances for residues of mevinphos in/on plant raw agricultural commodities (RACs) have
been established under 40 CFR § 180.157 and range from 0.2 ppm in/on cucumbers and tomatoes to
1.0 ppm in/on broccoli, cabbage, cauliflower, celery, spinach, and strawberries.
AMVAC is only supporting import tolerances for mevinphos residues in/on the following
commodities: broccoli, cabbage, cauliflower, celery, cucumbers, grapes, lettuce (leaf and head),
melons, peas (succulent), peppers, summer squash, spinach, strawberries, and tomatoes. The
tolerance for watermelons should be removed (reassigned) since the use is covered by the tolerance for
melons (Crop subgroup 9-A).
For risk assessment purposes, adequate plant and animal metabolism data are available.
However, acceptable residue data are tentatively available only for imported cucumbers and melons.
Additional residue data are needed to reassess import tolerances for broccoli, cabbage, cauliflower,
celery, grapes, lettuce, peas, peppers, spinach, squash, strawberries and tomatoes. To support the
existing residue data on cucumbers, melons, pea pods, peppers, strawberries, and tomatoes, data are
necessary depicting the storage stability of mevinphos residues in these frozen commodities at defined
lengths of storage time. Additional field trials are needed for broccoli, cabbage, celery, grapes, leaf
lettuce and head lettuce, succulent peas, peppers, spinach, strawberries, summer squash, and tomatoes.
Field trial data on broccoli will be translated to cauliflower.
Provided acceptable mevinphos labels are submitted and deficiencies pertaining to storage
stability of residues are resolved, sufficient data are available to reassess tolerances for mevinphos in/on
cucumbers and melons imported from Mexico. Although additional storage stability data are necessary
to support the cucumber and melon field trial data, the available data indicate the established tolerances
could be lowered to 0.05 ppm for cucumbers and 0.1 ppm for melons if the revised Mexican label
directions agree with the field trial parameters and if the existing cucumber residue data are validated by
storage stability data (a storage stability study MRID 45089101, entitled "Frozen Storage Stability of
Mevinphos Residues in/on Tomatoes, Strawberries, Broccoli, Lettuce, and Cucumbers" has been
submitted and is currently in review). Additional residue data are needed for broccoli, cabbage,
cauliflower, celery, grapes, lettuce, peas, peppers, spinach, summer squash, strawberries, and tomatoes
before the existing tolerances can be reassessed.
In addition, no residue data are available for grape and tomato processed commodities (a
grape processing study MRID 45021501 and a waiver request for the tomato processing study have
been submitted and are currently in review). Tolerances may be needed for mevinphos residues in/on
grape and tomato processed commodities. However, before the need for such tolerances can be
assessed, residue data are necessary depicting mevinphos residues in grape and tomato processed
commodities or information showing that mevinphos treated grapes and tomatoes are unlikely to be
used for processing in either Mexico or the U.S.
17
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Table 2. Tolerance Summary for Mevinphos
Commodity
Broccoli
Cabbage
Cauliflower
Celery
Cucumbers
Grapes
Lettuce
Melons (incl.
cantaloupes,
honey dew melon,
and muskmelon,
determined on the
edible portion
with rind
removed)
Peas
Peppers
Spinach
Squash, summer
Strawberries
Tomatoes
Watermelon
Tolerance Listed Under 40
CFR§180.157
1.0 ppm
1.0 ppm
1.0 ppm
1.0 ppm
0.2 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.25 ppm
0.25 ppm
1.0 ppm
0.25 ppm
1.0 ppm
0.2 ppm
0.5 ppm
Interim
Tolerance
Decision a
TBDb
TBDb
TBDb
TBDb
0.05
TBDb
TBDb
0.1
TBDb
TBDb
TBDb
TBDb
TBDb
TBDb
Reassign
Comment
Additional residue data are required.
Additional residue data are required.
Additional residue data are required d.
Additional residue data are required.
Cucumber
Import tolerance based upon
Mexican field trial data.
Grape
Additional residue data are required.
Additional residue data are required.
Melon (Crop subgroup 9-A)
Import tolerance based upon
Mexican and U.S. field trial data.
Pea, succulent
Additional residue data are required.
Pepper
Additional residue data are required.
Additional residue data are required.
Additional residue data are required.
Strawberry
Additional residue data are required.
Tomato
Additional residue data are required.
Covered by melons (Crop subgroup 9-
A)
18
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Commodity
Tolerance Listed Under 40
CFR §180. 157
Interim
Tolerance
Decision a
Comment
Tolerances potentially needed under 40 CFR §180.157:
Grape, juice
Grape, raisin
Tomato, paste
Tomato, puree
None
None
None
None
TBDC
TBDC
TBDC
TBDC
Data depicting residues in grape
processed fraction are required.
Data depicting residues in grape
processed fraction are required.
Data depicting residues in tomato
processed fraction are required.
Data depicting residues in tomato
processed fraction are required.
a Tolerances may be reassessed only upon completion of the cumulative risk assessment of all organophosphates.
The tolerance levels provided here are for this single chemical, if no cumulative assessment was required, that is
supported by all of the submitted residue data. The Agency will commence proceedings to revoke, modify the
existing tolerances, and correct commodity definitions.
b TBD = To be determined. Tolerance cannot be determined at this time because additional data are required. The
raising of any tolerances will be deferred, pending the outcome of the cumulative assessment.
0 TBD = To be determined because additional data are needed and the establishment of any new tolerances will be
deferred, pending the outcome of the cumulative assessment.
d Field trial data on broccoli will be translated to cauliflower.
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
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were 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 Disrupter
Screening Program (EDSP).
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When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, mevinphos may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
D. Regulatory Rationale
Mevinphos has fifteen import 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 not of concern for the Agency; therefore, no risk
mitigation measures are necessary at this time.
V. WHAT MANUFACTURERS NEED TO 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.). A subchronic study MRID 45099101 has
been submitted and is currently in review. A developmental neurotoxicity study in rats (with expanded
protocol to extend the postnatal treatment period and to measure cholinesterase inhibition in offspring)
and neurotoxic esterase (NTE) data on the hen are needed. Although mevinphos has no U.S.
registrations and therefore is not subject to a FIFRA DCI, it does have tolerances for residues in or on
broccoli, cabbage, cauliflower, celery, cucumbers, grapes, lettuce, melons, peas, peppers, spinach,
summer squash, strawberries, tomatoes, and watermelon that are imported into the U.S. If EPA needs
additional data to support the continuance of a tolerance or exemption, but there are no U.S. registrants
from whom the Agency can obtain the data under FIFRA, EPA may require data under section 408(f)
of FFDCA. Section 408(f) of FFDCA allows the Agency to publish a Notice in the Federal Register
describing the type of data needed and inviting persons willing to submit the necessary data to support
the tolerance to identify themselves. Tolerances may be revoked if no person commits to supply the
necessary data or if the appropriate data are not submitted in a timely manner. If the proposed
GC/FPD (phosphorous mode) tolerance enforcement method remains the manufacturer's choice for
enforcement, an independent laboratory validation of that method must be conducted prior to validation
of the method by the Agency (W. Hazel, October 19, 1999; D196769 and D248311). Alternatively,
FDA Multiresidue Protocol A or D had been demonstrated to be adequate for tolerance enforcement.
The Agency needs use directions that will appear on the Mexican label(s), additional field trial
data for broccoli, cabbage, celery, grapes, lettuce, peas, peppers, spinach, strawberries, summer
squash, and tomatoes; and storage stability data for cucumbers, melons, peas, peppers, strawberries,
and tomatoes to permit mevinphos tolerance reassessment. The field trials are all to be conducted in
Mexico; however, for grapes field trials are necessary in other countries where mevinphos is registered
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or used in or on grapes. A storage stability study MRID 45089101 has been submitted and is currently
in review. Processing studies on grapes and tomatoes are needed to support tolerances for these crops
if the imported crops are likely to be processed in the U.S. or if their processed commodities are
imported from Mexico, unless the Agency is provided with data indicating that mevinphos treated
grapes and tomatoes are unlikely to be used for processing in either Mexico or the U.S. A grape
processing study MRID 45021501 and request for a waiver from the tomato processing study
requirement have been submitted and are currently in review. Results of these studies may further refine
the risk assessments. EPA will be taking the necessary steps to secure these data in the near future.
B. Risk Mitigation Requirements
As discussed in this document, the acute and chronic food risk from the use of mevinphos on
imported broccoli, cabbage, cauliflower, celery, cucumbers, grapes, lettuce, melons, peas, peppers,
spinach, summer squash, strawberries, tomatoes, and watermelon is not of concern to the Agency;
therefore, no mitigation is necessary at this time. The Agency may need to pursue risk management
measures for mevinphos 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 January
12, 2000. On March 13, 2000 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 June 30, 2000.
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."
21
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22
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APPENDIX A: BIBLIOGRAPHY
MRID
CITATION
00036989 Shell Development Company (1956) Determination of OS2046 in Agricultural
Products and Animal Tissues: Enzyme Inhibition—Spectrophotometric Method.
Method ARMS-C-12/56 (Tentative) dated May 15, 1956. (Unpublished study
received Jun 5, 1956 under PP0078; CDL:092358-D).
0003 6990 Casida, I.E. (19??) Enzymatic Determination of OS 2046 in Agricultural Crops:
Enzyme Inhibition—delta pH Method. (Unpublished study received Jun 5, 1956 under
PP0078; prepared by Univ. of Wisconsin, submitted by Shell Chemical Co.,
Washington, D.C.; CDL:092358-E).
00089559 Shell Chemical Corporation (1957) Determination of Anticholinesterase in Plant and
Animal Tissues. Method dated Mar 1957. (Unpublished study received Apr 15, 1957
under PP0123; CDL:090154-Z).
00113309 Shell Chemical Corp. (1958) [Phosdrin: Residues in Oranges and Other Crops].
(Compilation; unpublished study received on unknown date under PP0200;
CDL:098743-A).
00113334 Shell Development Co. (1964) Determination of Phosdrin Insecticide in Crops and
Animal Products: Analytical Method MMS-6/64. (Unpublished study received Jul 1,
1964 under unknown admin, no.; CDL: 129696-A).
00147425 Shell Oil Co. (1985) Residue Decline of Phosdrin Insecticide on Various Agricultural
Crops. Unpublished compilation. 218 p.
40201401 Schroeder, R, Daly, I. (1987) A Teratology Study in Rats with Mevinphos.
Bio/dynamics, Inc.: Study Number: 85-3009, March 2, 1987. Unpublished.
40570701 Auletta, C. (1988) Acute Oral Toxicity Study in Rats with Mevinphos: Final Report:
Project No. 4644-87. Unpublished study prepared by Bio/dynamics Inc. 31 p.
40570702 Aulletta, C. (1988) Acute Dermal Toxicity Study in Rabbits with Mevinphos: Final
Report: Project No. 4645/87. Unpublished study prepared by Bio/dynamics Inc. 31
P-
23
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BIBLIOGRAPHY
MRID
CITATION
40570703 Auletta, C. (1988) Dermal Sensitization Study in Guinea Pigd with Mevinphos: Final
Report: Project No. 4648-87. Unpublished study prepared by Bio/dynamics Inc. 35
P-
40600001 Hoffman, G. (1988) An Acute Inhalation Toxicity Study of Mevinphos in the Rat:
Project No. 87-8050. Unpublished study prepared by Bio/dynamics, Inc. 92 p.
40775901 Barrett, D. (1988) Acute Delayed Neurotoxicity Study in Mature Hens with
Mevinphos. Bio/dynamics Inc., Study Number 4685-87, July 26, 1988. Unpublished.
41016201 Atkinson J. (1989) An Eighteen Month Oncogenicity Study in Mice with Mevinphos.
Bio/dynamics, Inc., East Millstone, NJ. Project No. 86-3006, February 23, 1989.
Unpublished.
41295001 San, R; Schadly, M. (1989) Salmonella/Mammalian-microsome Platelncorporation
Mutagenicity Assay (Ames Test) with a Confirmatory Assay with Mevinphos: Lab
Project Number: T8858/501014. Unpublished study prepared by Microbiological
Associates, Inc. 62 p.
41306301 Barbell, J. (1989) CHO/HGPRT Mutation Assay with Confirmation with Mevinphos:
Final Report: Lab Project Number: T8858/332001. Unpublished study prepared by
Microbiological Associates, Inc. 32 p.
41378701 Putman, D.; Morris, M. (1990) Chromosome Aberrations in Chinese Hamster Ovary
(CHO) Cells with Mevinphos: Final Report: Lab Study No. T8858.337. Unpublished
study prepared by Microbiological Associates, Inc. 29 p.
41378702 Curren, R. (1990) Unscheduled DNA Synthesis in Rat Primary Hepatocytes with
Mevinphos: Final Report: Lab Study No.: T8858.380. Unpublished study prepared by
Microbiological Associates, Inc. 26 p.
41546501 McKane, E.; Miller, M. (1990) Analysis of Field Residue Study Samples with Two
Formulations of Phosdrin on Two Varieties of Lettuce: Lab Project Number: AL-102:
AL-103. Unpublished study prepared by Pan-Agricultural Laboratories, Inc. 131 p.
24
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BIBLIOGRAPHY
MRID
CITATION
41546502 Amvac Chemical Co. (1990) Phosdrin Incident Reports on Lettuce. Unpublished
study. 46 p.
41636801 West J. and K. Roberts (1990) Supplement to An Eighteen Month Oncogenicity
Study in Mice with Mevinphos (Supplements MRID 41016201). Jellinek, Schwartz,
Connolly & Freshman, Inc., Washington, D.C. Project ID JCODE 1562.1, August 31,
1990. Unpublished.
41823801 Beyer, B.K., (1991) Teratology Study in Rabbits. EXXON Biomedical Sciences, Inc.,
East Millstone, NJ. Laboratory Project Id. 233134RB, February 22, 1991.
Unpublished.
41951801 Reddy, V., Freeman, T., Litle, L., Cannon, M. (1991) Disposition and Metabolism of
14C-Labeled Mevinphos in Rats. Midwest Research Institute, Kansas City, Mo.,
Laboratory Project Id. 9485-B, April 4, 1991. Unpublished.
42122201 Beyer, B. (1991) Multi-Generation Rat Reproduction Study MRD-88-331 Mevinphos:
Final Report: Lab Project Number: 233135. Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 484 p.
42422201 Beyer, B.K., (1991) Teratology Study in Rabbits (Revision). EXXON Biomedical
Sciences, Inc., East Millstone, NJ. Laboratory Project Id. 233134RB, February 22,
1991. Unpublished.
42475601 Velagaleti, P.; Denison, J.; Cristy, T. (1992) Nature of the Residue of [Carbon
14]-labeled Mevinphos in Leaf Lettuce: Final Report: Lab Project Number:
SC910004. Unpublished study prepared by Battelle. 152 p.
42476701 Craine, E. (1992) A Residue Chemistry Study in the Dairy Goat with [carbon
14]-Mevinphos: Lab Project Number: WIL-163001: RPT0086. Unpublished study
prepared by WIL Research Labs, Inc. 307 p.
42540101 Velagaleti, P.; Denison, J.; Cristy, T. (1992) Nature of the Residue of [carbon
14]-Labeled Mevinphos in Strawberries: Final Report: Lab Project Number:
SC910069: SPONSOR. Unpublished study prepared by Battelle. 182 p.
25
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BIBLIOGRAPHY
MRID
CITATION
42588501 Keefe, R. (1992) 90-Day Subchronic Oral Toxicity Study in Rats with Mevinphos
(MRD-88-331): 233170B. EXXON Biomedical Sciences, Inc., Los Angeles, CA.
Laboratory Project ID 233170B, November 4, 1992. Unpublished.
42659201 Craine, E. (1993) A Residue Chemistry Study in the Laying Hen with (carbon
14)-Mevinphos: Lab Project Number: WIL-188001. Unpublished study prepared by
WIL Research Labs., Inc. 320 p.
42674001 Velagaleti, P.; Denison, J.; Cristy, T. (1993) Nature of the Residue of (carbon
14)-Mevinphos in Turnips: Final Report: Lab Project Number: SC910070.
Unpublished study prepared by Battelle. 189 p.
42964601 Schweitzer, M.; Andrews, K. (1993) Enforcement Validation for the Determination of
Mevinphos Residues in Crop Samples: Lab Project Number: SC930248. Unpublished
study prepared by Battelle. 36 p.
42985401 Lamb, I.C., (1993) A Range-Finding Acute Study of Mevinphos in Rats. WIL
Research Laboratories, Inc., Ashland, OH, Laboratory Study No. WIL-188005,
October 12, 1993 . Unpublished.
42985402 Lamb, I.C., (1993) An Acute Neurotoxicity Study of Mevinphos in Rats. WIL
Research Laboratories, Inc., Ashland, OH, Laboratory Study No. WIL-188006,
October 13, 1993. Unpublished.
43088601 Plutnick, R.T., (1994). 2-Year Chronic Toxicity/Oncogenicity Study in Rats with
Mevinphos (MRD-88-331). EXXON Biomedical Sciences, Inc., East Millstone, NT,
Laboratory Project Id. 233170C, January 3, 1994. Unpublished.
44595201 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Broccoli Grown in Mexico: Lab Project Number: AMV96001. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 69 p.
(OPPTS 860.1500}
26
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BIBLIOGRAPHY
MRID
CITATION
44595202 Kent, Y; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos in/on
Cabbage Grown in Mexico: Lab Project Number: AMV96002. Unpublished study
prepared by Pesticides Regulatory Advisory and ABC Laboratories. 68 p. (OPPTS
860.1500}
44595203 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Spinach Grown in Mexico: Lab Project Number: AMV96003. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 69 p.
{OPPTS 860.1500}
44595204 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Leaf Lettuce Grown in Mexico: Lab Project Number: AMV96004. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 69 p.
{OPPTS 860.1500}
44595205 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Melons in Mexico: Lab Project Number: AMV96005. Unpublished study
prepared by Pesticides Regulatory Advisory and ABC Laboratories. 67 p.
{OPPTS860.1500}
44595206 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Peas Grown in Mexico: Lab Project Number: AMV96006. Unpublished study
prepared by Pesticides Regulatory Advisory and ABC Laboratories. 69 p.
{OPPTS860.1500}
44595207 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Spinach Grown in Mexico: Lab Project Number: AMV96007 Project Number:
AMV96007. Unpublished study prepared by Pesticides Regulatory Advisory and
ABC Laboratories. 69 p. {OPPTS 860.1500}
44595208 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Strawberries Grown in Mexico: Lab Project Number: AMV96008. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 70 p.
{OPPTS 860.1500}
27
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BIBLIOGRAPHY
MRID
CITATION
44595209 Kent, Y.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Squash Grown in Mexico: Lab Project Number: AMV96009. Unpublished study
prepared by Pesticides Regulatory Advisory and ABC Laboratories. 68 p.
{OPPTS860.1500}
44595210 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Peppers Grown in Mexico: Lab Project Number: AMV96010. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 90 p.
(OPPTS 860.1500}
44595211 Taylor, A.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Tomato Grown in Mexico: Lab Project Number: AMV96011. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 123 p.
{OPPTS860.1500}
44595212 Kent, Y.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Grapes Grown in Mexico: Lab Project number: AMVAC96012. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 122 p.
{OPPTS860.1500}
44595213 Kent, Y.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Cucumber Grown in Mexico: Lab Project Number: AMV96013. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 134 p.
{OPPTS 860.1500}
44595213 Kent, Y.; Obrist, J. (1998) Determination of Magnitude of Residues of Mevinphos
in/on Cucumber Grown in Mexico: Lab Project Number: AMV96013. Unpublished
study prepared by Pesticides Regulatory Advisory and ABC Laboratories. 134 p.
{OPPTS 860.1500}
44595214 Obrist, J. (1997) Magnitude of Mevinphos Residues in Celery: Lab Project Number:
957SARS-93-07: SARS-93-CA-16C: 41278. Unpublished study prepared by ABC
Laboratories and Stewart Agricultural Research. 190 p.
28
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BIBLIOGRAPHY
MRID
CITATION
44595215 Obrist, J. (1997) Magnitude of Mevinphos Residues in Succulent Peas: Lab Project
Number: 41342: SARS-93-10: SARS-94-MN-19B. Unpublished study prepared by
ABC Labs. 237 p.
44595216 Obrist, J. (1997) Magnitude of Mevinphos Residues in Strawberries: Lab Project
Number: 93335: SARS-93-12. Unpublished study prepared by ABC Laboratories.
222p.
44595217 Obrist, J. (1997) Magnitude of Mevinphos Residues in Spinach: Lab Project Number:
41277: SARS-93-06. Unpublished study prepared by ABC Laboratories. 189 p.
44595218 Obrist, J. (1997) Magnitude of Mevinphos Residues in Cabbage: Lab Project Number:
41273: SARS-93-02. Unpublished study prepared by ABC Labs. 169 p.
44595219 Obrist, J. (1997) Magnitude of Mevinphos Residues in Grapes: Lab Project Number:
93325: SARS-93-11. Unpublished study prepared by ABC Laboratories. 180 p.
44595220 Obrist, J. (1997) Magnitude of Mevinphos Residues in Cantaloupe: Lab Project
Number: 93-08: 41279. Unpublished study prepared by ABC Laboratories. 125 p.
44595221 Obrist, J. (1997) Magnitude of Mevinphos Residues in Leaf Lettuce: Lab Project
Number: SARS-93-05: 41276. Unpublished study prepared by ABC Laboratories.
257 p.
44608501 Obrist, J. (1997) Magnitude of Mevinphos Residues in Broccoli: SARS-93-01: Lab
Project Number: 41270: SARS-93-01 :SARS-93-CA-10A. Unpublished study
prepared by ABC Labs., Inc. 192 p.
44608502 Obrist, J. (1997) Magnitude of Mevinphos Residues in Head Lettuce: SARS-93-04:
Lab Project Number: 41275: SARS-93-04:SARS-93-CA-13A. Unpublished study
prepared by ABC Labs., Inc. 225 p.
45021501 Leppert, B. (1994) Magnitude of Mevinphos in Grapes for Processing: SARS-93-16:
Lab Project Number: SARS-93-16: SARS-93-CA-25. Unpublished study prepared
by Pan-Agricultural Labs., Inc. 228 p.
29
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BIBLIOGRAPHY
MRID CITATION
45089101 Gant, A. (1999) Frozen Storage Stability of Mevinphos Residues in/on Tomatoes,
Strawberries, Broccoli, Lettuce, and Cucumbers: Lab Project Number 44693.
Unpublished study prepared by ABC Labs., Inc. 599 p.
45099101 Lamb, I. (1994) A Subchronic (13 Week) Neurotoxicity Study of Mevinphos In Rats:
Lab Project Number WIL-188007. Unpublished study prepared by WIL Research
Labs., Inc. 2005 p.
CITATIONS WITHOUT MRID NUMBERS
HED DOC. NO. 013334: Mevinphos - Report of the Hazard Identification
Assessment Review Committee, Memorandum from Virginia Dobozy and Brenda
Tarplee, dated April 13, 1999.
HED DOC. NO. 013678: Mevinphos Cancer Issues, Memorandum from William L.
Burnam, dated August 4, 1999.
HED DOC. DP Barcode D251794: Mevinphos: Toxicology Chapter for RED,
Memorandum from Virginia Dobozy, dated August 16, 1999.
HED DOC. NO. 013752: Mevinphos - Report of the FQPA Safety Factor
Committee, Memorandum from Brenda Tarplee, dated September 28, 1999.
HED DOC. DP Barcode D259803: Mevinphos. Dietary Exposure and Risk Analyses
for the HED Preliminary Human Health Risk Assessment, Memorandum from Christine
Olinger, dated October 18, 1999.
HED DOC. DP Barcode D259802: Mevinphos: Residue Chemistry Chapter of the
Reregistration Eligibility Decision Document, Memorandum from William Hazel, dated
October 19, 1999.
HED DOC. DP Barcode D196769 and D248311: Radiolabeled Method Validation
Data for proposed Enforcement Method and Magnitude of the residue Data Supporting
Import Tolerances for Mevinphos, Memorandum from W. Hazel, dated October 19,
1999.
30
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APPENDIX B: LIST OF AVAILABLE RELATED DOCUMENTS
These documents are available from the Public Docket Office or at the following web site:
http://www.epa.gov/pesticides/op/mevinphos.htm
1. Hazard Assessment of the Organophosphates
2. FQPA Safety Factor Recommendations for the Organophosphates
3. Frequently Asked Questions
4. Federal Register Notice Vol. 65, Number 8, Pages 1867-1869, January 12, 2000 (Comment
period ending March 13, 2000)
5. Report of the Hazard Identification Assessment Review Committee
6. Federal Register Final Rule Vol. 64, Pages 41818-41823, August 2, 1999; Tolerance Actions
7. Toxicology Chapter for RED
8. Note to reader
9. Report of the FQPA Safety Factor Committee
10. Dietary Exposure and Risk Analyses for the HED Preliminary Human Health Risk Assessment
11. Preliminary Human Health Risk Assessment
12. Residue Chemistry Chapter of the Reregistration Eligibility Decision Document.
13. Registrant's Response to Residue Chemistry Data Requirements
14. Letter to AMVAC Transmitting Preliminary Risk Assessment
15. AMVAC's Comments on the Preliminary Risk Assessment
16. AMVAC's Letter on Studies Resubmitted in Response to the Preliminary Risk Assessment
17. Questions and Answers
18. Response to Registrant's Error Comments on the Preliminary Risk Assessment
19. Letter to AMVAC Requesting Studies
20. Federal Register Notice Vol. 65, Number 127, Pages 40631-40632, June 30, 2000
(Comment period ending August 29, 2000)
21. Revised Human Health Risk Assessment.
22. Overview of Mevinphos Revised Risk Assessment
23. Mevinphos Summary
24. Response to Public Comments on Preliminary Risk Assessment
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