United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA 73E-R-Q2-00 f
DATE August 2002
Interim Reregistration
Eligibility Decision (IRED)
Mefhamidophos
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7S08CS
EPA 738-F-02-008
August 2002
SERA Methamidophos Facts
EPA has 'assessed the risks of methamidophos and reached an Interim Rcrcgistration
Eligibility Decision (IRED) for this organophosphate (OP) pesticide. Although current uses may pose
unreasonable adverse effects to human health and the environment, these effects can be mitigated by
the measures identified in the Methamidophos IRED. Provided that these risk mitigation measures
are adopted, methamidophos' individual, aggregate-risks will be within acceptable levels, and the
pesticide will be eligible for reregistratioE once EPA has considered the cumulative risks of the OPs.
Used to control insects on potatoes, cotton,
and tomatoes, methamidophos residues in food do
not pose risk concerns. Screening level modeling ,
estimates indicate that drinking water from surface
water sources may pose risk concerns. However,
actual drinking water exposures and risks are likely
to be lower than predicted by these estimates. EPA
will require confirmatory surface water monitoring
data to confirm its current interim conclusion that
drinking water risks are not of concern and do not
require mitigation. Methamidophos has no
residential uses, so children, and others should not be
significantly exposed to this pesticide around the
home. EPA assumes that methamidophos will fit -
into its own "risk cup;" it will not pose significant
dietary or aggregate risk concerns. Methamidophos
poses risks of concern to workers who mix, load, and
apply the pesticide to agricultural sites, and to
workers who re-enter treated agricultural areas.
Birds, mammals, and freshwater invertebrates also
encounter risks of concern. With mitigation
measures, these worker and ecological risks will be .
below levels of concern for reregis&stkttL
EPA's next step under the Food Quality
Protection Act (FQPA) is to consider the cumulative
effects of the OP pesticides, which, share a common
mechanism of toxicity. The interim decision on methamidophos will not be final until OP cumulative
risks have been considered. The OP cumulative assessment may result in further risk mitigation
measures for methamidophos.
The OP Pilot Public Participation Proess
The organophosphates (OPs) are a group
of related pesticides that affect the functioning of
the nervous system. They are among EPA's
highest priority for review in implementing
provisions of the Food Quality Protection Act
(FQPA) of 1996.
EPA encourages the public to participate
in the review of the OP pesticides. Through a six-
phased pilot public participation process, The
Agency has released for review and comment its
preliminary and revised scientific risk assessments
for individual OPs. (Piease-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. The Agency will make
final decisions after considering the cumulative
risks of the OPs. (Please see
www.epa.aoy/pesticides/cumuiatiye.htmj
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EPA is reviewing the OP pesticides to determine whether they meet current health and safety
standards. Older OPs require decisions about their eligibility for reregistration under FIFRA. OPs
with food, drinking water, residential, and any other non-occupational exposures must be reassessed to
make sure they meet the new FFDCA safety standard, brought about by FQPA.
The methamidophos interim decision was made through the OP pilot public participation
process, which has increased transparency and maximized stakeholder involvement in EPA's
development of risk assessments and risk management decisions. EPA worked extensively with
affected parties to reach the decisions presented in this interim decision document
Uses
• An insecticide/acaricide, methamidophos is used to control a broad spectrum of insects in
cotton, potato, and tomato crops (the latter for special local needs only). Methamidophos also
is registered for use in California on alfalfa grown for seed, a nonfood use. It is used on
peppers, strawberries, and squash grown in other countries and imported into the U.S. (import
tolerances are established or pending for these uses). Methamidophos has no residential uses.
Approximately 640,000 pounds of the active ingredient methamidophos are used annually.
Use is highest on potatoes (87% of the total pounds applied), followed by tomatoes (8%) and
cotton (5%).
• Methamidophos is classified as a Restricted Use Pesticide.
Health Effects
* Methamidophos can cause cholinesterase inhibition in humans; that is, it can overstimulatc
the nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
accidents or major spills), respiratory paralysis and death.
* Methamidophos also is one of the most acutely toxic organophosphate pesticides.
Risks
• Methamidophos is a metabolite of the OP pesticide acephate. EPA's food risk assessments,
and to some extent the drinking water assessment, encompass the risk from applications of
methamidophos only and from "all sources," which includes applications of acephate.
* EPA's human health risk assessment for methamidophos indicates some risk concerns.
Dietary risk from food sources alone is not of concern. Screening level modeling estimates
indicate that acute and chronic dietary risks from surface water sources of drinking water are
above the Agency's level of concern for all segments of the population. Due to uncertainties
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and limitations of model predictions, however, actual drinking water exposures and risks from
methamidophos are likely to be lower than estimated.
Residential risks are not of concern because methamidophos is not registered for use in
residential settings. Methamidophos is a metabolite of acephate, which had numerous
residential, recreational, and institutional uses that were evaluated and mitigated through the
Acephate IRED. Post-mitigation risks for these uses, associated with, the degradation of
acephate to methamidophos, were evaluated in the Acephate IRED and found to be negligible.
Occupational exposure to methamidophos is of concern to the Agency. EPA las risk
concerns for workers who mix, load, and/or apply methamidophos to agricultural sites, and for
workers who re-enter treated agricultural areas.
• EPA also has identified acute and chronic risks to birds and mammals, and some risk to
freshwater invertebrates, that are of concern.
Risk Mitigation
The following mitigation, measures are required for methamidophos to address drinking water, <
worker, and ecological risks of concern.
To mitigate dietary risks:
• Because actual drinking water exposures are likely lower than predicted by modeling
estimates, EPA has made an interim determination that no additional mitigation is
necessary at this time. The Agency will require confirmatory surface water
monitoring data for methamidophos to refine the drinking water modeling values
based on actual concentrations in drinking water sources, to confirm this interim
conclusion.
• To mitigate residential risks:
• Methamidophos has no residential uses, so risk mitigation is not necessary.
• To mitigate occupational risks to agricultural handlers:
• The cotton, use must be cancelled. This use will be phased out over 5 years to allow
ample time for transition to alternatives,
• Applicators must be in an enclosed cab tractor or enclosed cockpit
• Flaggers must be in enclosed vehicles, mechanical flaggers must be used, or global
positioning system (GPS) equipment that negates the need for flaggers for aerial
application must be used.
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• To mitigate occupational risks to post-application agricultural workers:
* For tomatoes, increase Restricted Entry Intervals (REIs) for all activities to 4 days in
all states except California, where the REI will remain at 3 days per the current labels.
• For potatoes, increase REIs for all activities to 4 days.
• To mitigate ecological risks to terrestrial birds and mammals, and to freshwater and estuarine
invertebrates:
* Phase out and cancel the cotton use, and implement the other occupational risk
mitigation measures listed above.
For cotton during the phase-out period, reduce the maximum number of applications
to 2 per season.
• For tomatoes, reduce the maximum number of applications to 4 per season.
Next Steps
• Numerous opportunities for public comment were offered as this decision was being
developed. The Methamidophos IRED therefore is issued in final, without a formal public
comment period. (Please see www.epa.gov/pesticides/reregistration/status.htm or
www.epa.gov/pestieides/op ). The docket remains open, however, and any comments
submitted in the future will be placed in this public docket.
Once EPA has considered the cumulative risks of the OP pesticides, the Agency will issue its
final tolerance reassessment decision for methamidophos and may need to pursue further risk
management measures. The Agency will revoke seven methamidophos tolerances now
because no corresponding uses are registered at present; will modify three tolerances; and
will correct several other commodity definitions. For all OPs, tolerances will not be raised or
established until cumulative risks have been considered.
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i A u
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Eirata Sheet for Changes to the Methamidophos Interim Rercgistration Eligibility
Decision.
1) In Section V of the IRED, OPPTS guideline numbers were updated (i.e.. Photolysis on Soil,
OPPTS 161-3, was changed to OPPTS 835.2410).'
2) The previous contact for methamiiophos, Mark Hartman, has been replaced by Craig Doty,
the current Chemical Review Manager.
3) General grammatical errors were corrected.
FROM:
Director
Special Review and Reregistratioa Divsion
TO:
Public Docket for Endosulfan
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UNITED STATES ENVIRONMENTAL PROTECTION AGEWCY
WASHINGTON, D.C. 20460
OFHCEOF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
April 7, 2002
CERTtf'lF.B MATT,
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or
the Agency) has completed its review of the available data and public comments received related to the
preliminary and revised risk assessments for the organophosphate pesticide methamidophos. Hie
public comment period on the revised risk assessment phase of the reregistetion process is closed.
Based on comm ents received during the public comment period and additional data received fern fee
registrant, the Agency revised the human health and environmental effects risk assessments and made
them available to the pubic on February 3,2000. Additionally, the Agency held a Technical Briefing
on February 3,2000, where the results of the revised human health and environmental effects risk
assessments were presented to the general public. This Technical Briefing concluded Phase 4 of the
OP Public Participation Pilot Process developed by fee Tolerance Reassessment Advisory Committee,
and initiated Phase 5 of that process. During Phase 5, all interested parties were invited to participate
and provide comments and suggestions on ways the Agency might mitigate fee estimated risks
presented in fee revised risk assessments. This pubic participation and comment period commenced
on February 22,2000 , and closed on April 22,2000.
Based on its review, EPA has identified risk mitigation measures thai the Agency believes
mitigation measures are necessary to address fee human health and environmental risks associated with
the current use of methamidophos. The EPA is now publishing Its interim decision on fee' reregisfeation
eligibility of and risk management decision for fee current uses of methamidophos and its associated
human health and environmental risks. The reregistration eligibility and tolerance reassessment decisions
for methamidophos will be finalized once fee cumulative risks for all of the organophosphate pesticides
are considered. The enclosed "Interim Reregistetion Eligibility Decision for methamidophos " which
was approved on April 5,2002, contains the Agency's decision on fee individual chemical ¦
methamidophos.
A Notice of Availability for this Interim Reregistrstion Eligibility Decision for methamidophos is
being published in the Federal Register. To obtain a copy of fee interim RED document, please
contact fee QPP Public Regulatoiy Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania
Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the interim
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RED and all supporting documents are available on the Internet. See http:www.epa.gov/pesticides/op.
The interim RED is basal on the updated technical information found in the methamidophos
public docket. Hie docket not only includes background information and comments on the Agency's
preliminaiy risk assessments, it also now includes the Agency's revised risk assessments for
methamidophos {Revised Dietary Exposure and Risk Analyses for the BED Revised Human
Health Risk Assessment, July 19,2000, Methamidophos: Addendum to the Revised Occupational
and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility
Decision Document, September 15, 2000. Recalculated Tier IIDrinking Water EECs for
Methamidophos Incorporating the Index Reservoir and Percent Cropped Area, October 17,
2000.), and a document summarizing the Agency's Response to Comments. The Response to
Comments document addresses corrections to the preliminary risk assessments submitted by chemical
registrants, as well as responds to comments submitted by the general public and stakeholders during
the comment period on the risk assessment The docket will also include comments on the revised risk
assessment, and any risk mitigation proposals submitted during Phase 5. For methamidophos, no
proposal was submitted by Bayer, the technical registrant.
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for these 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 cm the organophosphate pesticides and to engage the public in the
reregistration and tolerance reassessment processes for these chemicals. This open process follows the
guidance developed by the Tolerance Reassessment Advisory Committee (TRAC), a large multi-
stakeholder advisoiy body that advised the Agency on implement ing 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 methamidophos risk assessment and the attached interim RED concern only
this particular organophosphate. This interim RED presents the Agency's conclusions on the dietary
risks posed by exposure to methamidophos alone. The Agency has also concluded its assessment of
the ecological and worker risks associated with the use of methamidophos. Because the FQPA directs
the Agency to consider available information on the basis of cumulative ride 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 organophosphate class of chemicals after considering the risks for the individual
organophosphates. The Agency is working towards completion of a methodology to assess cumulative
risk and the individual risk assessments for each organophosphate are likely to be necessaiy elements
of any cumulative assessment. The Agency has decided to move forward with individual assessments
and to identify mitigation measures necessaiy to address those human health and environmental risks
associated with the current uses of methamidophos. The Agency will issue the final tolerance
reassessment decision for methamidophos and finalize decisions on reregistration eligibility once the
cumulative risks for all of the organophophates are considered.
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This document contains a generic and/or.a product-specific Data Call-Ms) (DCI) that outline(s)
further data requirements for this chemical. Note that a complete DCI, with all pertinent instructions, is
being sent to registrants under separate cover. Additionally, for product-specific DCIs, the first set of
required responses to is due 90 days from the receipt of the DCI letter. The second set of required
responses is due eight months from the date of the DCI.
In this interim RED, the Agency has determined that methamidophos will be eligible for
reregistrafion provided that all the conditions identified in this document are satisfied* including
implementation of the risk mitigation measures outlined in Section IV of the document The Agency
believes that current uses of methamidophos may pose unreasonable adverse effects to human health
and the environment and that such effects can be mitigated with the risk mitigation measures identified
"in this interim RED. Accordingly, the Agency recommends that registrants implement these risk
mitigation measures immediately. Sections IV and V of this interim RED describe labeling amendments .
for end-use products and data requirements necessary to implement these mitigation measures; •
Instructions for registrants on submitting the revised labeling can be found in the set of instructions for
product-specific data that accompanies this interim RED.
Should a registrant fail to implement any of the risk mitigation measures outlined in this document,
the Agency will continue to have concerns about the risks posed by methamidophos. Where the ¦
Agency has identified any unreasonable adverse effect to human health and the environment, the
Agency may at any time initiate appropriate regulatory action to address this concern. At that time, any
affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for registration, please
contact the Special Review and Reregisiration Division representative, Mark A. Hartman, at (703)
308-0734. For questions about product ^registration and/or the Product DCI that accompanies this
document, please contact Bonnie Adler at (703) 308-8523.
• Sincerely.
Lois A. Rossi, Director
Special Review and
Reregistratian Division
Attachment
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Interim Reregisfrattoii Eligibility Decision
for
Methamidophos
Case No, §§43
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TABLE Of CONTENTS
Esecattve SranBiaiy — .... 1
L Introduction............... ' 6
31 Chemical Overview 8
A. Regulatory History 8
EL Chemical Identification 8
C Use Profile 9
D. Estimated Usage of Pesticide 10
IH. Summary of Mrfkamidophos Risk Assessment 11
A. Human Health Risk Assessment 11
1. DietaryRfskfromFood 12
a. Toxicity 12
b. FQPA Safety Factor .. 13
c. Population Adjusted Dose (PAD) 13
d. Exposure Assumptions ......... 14
e. - Food Risk Characteristics'!! 14
2. Dietary Risk from Drinking Water 15
a. Surface Water 15
b. Ground Water 17
c. Drinking Water Levels of Comparison (DWLOCs) 18
3. Aggregate Risk 19
4. . Occupational and Residential Risk 20
a. Toxicity ' 20
b. Exposure 21
c. Occupational Handler Risk Scminaiy 22
1) Agricultural Handler Risk ' 23
2) Post-Application Occupational Risk ........... 24
B. Environmental Risk Assessment 25
1. Environmental Fate and Transport 25
.2. Ecological Risk Assessment 26
a. Ecological Hazard Profile 26 •
b. Risk to Birds and Mammals 28.
e. Risk to Aquatic Animals 29
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IV. Interim Risk Management and Reregistration Decision 34
A. Determination of Interim Reregistration Eligibility 34
B. Summary' of Phase 5 Comments and Responses 35
C. Regulatory' Position 39
1. FQPA Assessment 39
a. "Risk Cup" Determination 39
b. Tolerance Summary 40
2. Endocrine Disruptor Effects 46
3. Labels 46
a. Agricultural Use Exposure Reduction Measures........... 46
b. Homeowner Use Exposure Reduction Measures .......... 47
D. Regulatory Rationale .47
1. Human Health Risk Mitigation 47
a. Dietary Mitigation 47
1) Acute Dietary (Food) 47
2) Chronic Dietary (Food) 48
3) Drinking Water 48
b. Homeowner Risk Mitigation 50
c. Aggregate Risk Mitigation 50
d. Occupational Risk Mitigation 51
1) Agricultural Uses 51
2. Environmental Risk Mitigation 56
E. Other Labeling 57
1. Endangered Species Statement 57
2. Spray Drift Management 57
F. Methamidophos Risk Mitigation Summary 59
1. Dietary Risk .59
2. Occupational Risk 59
3. Ecological Risks 60
V. What Registrants Need to Do 61
A. Data Call-In Responses 61
B. Manufacturing Use Products 62
1. Additional Generic Data Requirements 62
2. Labeling for Manufacturing Use Products 63
C. End-Use Products 63
1. Additional Product-Specific Data Requirements 63
2. Labeling for End-Use Products 63
D. Existing Stocks 64
E. Labeling Changes Summary Table 65
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¦VI. Related Documents and How to Access Them 76
A, Availability at OFF Docket Room .. 76
B. Availability on the Internet .. 76
Appendix A* ' Use Patterns Eligible for Reregistratiou 79
Appendix®: Data Supporting Guideline Requirements for the Reregistratiou off
MethamMopiies 85
Appendix. C: Technical Support Documents 95
Appendix D: BiMography ' 97
Appendix E: Generic Data Call In... 121
Appendix F: Product Specific Data Call In 129
Appendix G; EPA'S Batching of Methamidopiios Products for Meeting Acute Toxicity
Data Reqnirememts for Rercgistration ' 141
Appendix H: List of Registrants Sent DC3s ...... 143
Appendix I;List of Available Related Documents and Electronically
Available Forms 145
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Metlhaimdophos TEAM
Office of Pesticide Programs:
Health Effects Rid: Assessment
Felecia Fort .
Susan Hanley
Nancy McCarroll
Environmental Fate Risk Assessment
Michael Davy
Ian Kennedy
Stephanie Syslo
Use and Usage Analysis
¦TimofliyKiely
Angel Chili
Donald Atwood
Registration Support
Marilyn Mautz
Risk Management
Mark Hartman
Elizabeth Vizard-Knee
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GLOSSARY OF TEEMS AND ABBREVIATIONS
AE
ai
AGDCI
ai
aPAD
AR ,
ARC
BCF
CAS
CI
CNS
cPAD
CSF
CFR
CSFII
DCI
DEEM
DFR
DEES
DWEL
DWLOC
EC
EEC
EPA
FAO
EDA
FIFRA
FFDCA
FQPA
FOB
G •
GENEEC
GLC
GLM
GM .
GRAS
HA
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
Dietaiy Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL)' Hie DWEL represents a medium specific
(ije., drinking water) lifetime exposure at which adverse, ncmcarckqgenie health effects
are not anticipated to occur.
Drinking Water Level of Comparison.
Ernulsifiable 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 Drag Administration
Federal Insecticide, Fungicide, and Rodeiiticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Her I Surface Water Compute Model
Gas Liquid Chromatography
Guideline Number • . .
Geometric Mean
Generally Recognized as Safe as Designated by EDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities
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HAFT
HOT
IR
IX5o
LD.
50
LEL
LOG
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
NPDES
NR
OP
OPP
OPPTS
Pa
PAD
PADI
PAG
PAM
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.
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.
Lowest Effect Level
Level of Concern
Limit of Defection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
pascal, the pressure exerted by a force of one newton acting on an area of one square
meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
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PCA
Percent Crop Area
PDF
' USDA Pesticide Data Program
PIED
Pesticide Handler's Exposure Date
PHI .
Preharvest Interval
ppb
Parts Per Billion
PPE
Personal Protective Equipment
ppm :
• Parts Per Million
PRN
Pesticide Registration Notice
ERZM/
EXAMS
Tier II Surface Water Computer Model '
Qi* ¦'
Hie Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC
Raw Agriculture Commodity
RBC
Red Blood Cell
RED
Reregisnatioa Eligibility Decision
1EI
' Restricted Entry Interval
KfD
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
Safely Factor
SLC
Single Layer Clothing
SLN
Special Local Need (Registrations Under Section 24(c) of Fit MA)
TC
Toxic Concentration. The concentration at which, a substance produces a toxic effect
ID
Toxic Dose. The dose at which a substance produces a toxic effect
IEP
Typical End-Use Product .
TGAI
Technical Grade Active Ingredient
TLC
• Thin Layer Chromatography •
TMRC
Theoretical Maximum Residue Contribution
ton
A wilt of pressure needed to support a column of mercury 1 mm high under standard
conditions.
TRR
Total Radioactive Residue
UF
Uncertainty Factor
¦nsfe
Micrograms Per Gram
pgL
Micrograms Per Liter
USDA
United Stales Department of Agriculture
USGS
United States Geologies! Survey
uv
Ultraviolet . .
WHO
' World Health Organization
WP
WettaMe Powder
WPS '
Worker Protection Standard.
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Executive Summaiy
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for methamidophos. Hie decisions outlined in tills document do
not include fee final tolerance reassessment decision for methamidophos; however, some tolerance
actions will be undertaken prior to completion of the final tolerance reassessment Seven tolerances will
be revoked now, because there are no currently registered uses; three tolerances will be modified, and
several oilier commodity definitions will be corrected. The final tolerance reassessment decision for this
chemical will be issued once the cumulative risks for all of the organophosphates are considered. The
Agency may need to pursue further risk management measures for methamidophos once cumulative
risks are considered.
The revised risk assessments are based on review of the required target data base supporting
the use patterns of currently registered products and new information received. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the
Agency issued its risk mitigation decision on methamidephos. After considering the revised risks and
comments and mitigation suggestions from the technical registrant Bayer, and other interested parties
EPA developed its risk management decision for uses of methamidophos that pose risks of concern.
This decision is discussed My in this document.
Methamidophos is an organophosphate insecticide used on a variety of insects, first registered
in 1972 for cotton, potatoes and numerous other crops. Use data from 1999 and 2000 indicate an
average annual domestic use of approximately 640,000 pounds of active ingredient (lbs ai) of
methamidophos.
Hie methamidophos risk assessments are different than those for most organophosphate
pesticides because methamidophos is a metabolite of the organophosphate pesticide acephate.
Consequently, the dietary (food) assessments, and to some extent the drinking water assessment,
encompass the risk,of methamidopfaos fiom applications of methamidophos only, and from "all sources"
which includes applications of acephate. Mefeamidophos is' not registered for use in residential settings.
Previously, acephate had numerous residential recreational and institutional uses which were evaluated
in the acephate MED. To mitigate risks of concern, acephate use in these settings have been limited to
indoor use in institutional settings such as schools and hospitals, use on ornamentals in the residential
settings, spot or mound treatments for fire ant control, and use on golf course turf. Hie risks
associated with the degradation of acephate to methamidophos for these uses were evaluated in the
acephate IKED and were found to be negligible.
Overall Risk Summary
EPA's human health risk assessment for methamidophos indicates some risk concerns. Food
risk, both acute and chronic, is below the Agency's level of concern. Drinking water risk estimates
based on screening models, from surface water for acute and chronic exposures, is of concern for all
1
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populations. Conversely, drinking water risk estimates based on screening models, from ground water
for acute and chronic exposures, is not of concern for alJ populations. There are concerns for workers
who mix, lewd, and apply methamidophos to agricultural site and to workers who re-enter treated
arras. Also, EPA has identified acute and chronic risk to birds and mammals that are of concern, and
some risk to freshwater invertebrates.
To mitigate risks of concern posed by the uses of methamidophos the Agency has decided on a
number of label amendments to address the worker, drinking water and ecological concerns. Results
of the risk assessments, and the necessary label amendments to mitigate those rides, are presented in
this interim RED.
Dietary Ride ffood>
Acute and chronic dietary risk assessments for food do not exceed the Agency's level of
concern; therefore, no mitigation is warranted at this time for dietary (food) exposure to
methamidophos from food.
Dietary (drinking watefV
Surface water estimated concentrations were derived from the PRZM-EXAMS model with the
Standard Index Reservoir and percent crop area (PCA) and the GEENEC model (for methamidophos
derived from application of acephate). Ground water estimated concentrations were derived from the
SCI-GROW Model. These are screening level estimates designed to provide high-Mid estimates of
potential pesticide exposure. Such predictions provide a screen to eliminate those chemicals that are
not likely to cause concerns in drinking water. Exceedanees in drinking water risk assessments using
the screening model estimates do not necessarily mean a risk of concern actually exists, but may
indicate the need for better data (e.g., monitoring studies specific to use patterns and drinking water
sources) on which to confirm decisions.
Based on model prediction s of currently registered uses, the EECs for methamidophos from the
application of methamidophos in surface water range from 28.6 to 61.8 ppb for acute exposure, and
from 1.5 to 3.8 ppb for chronic exposure. The only surface water EEC calculated for methamidophos
from the application of acephate, using the Tier I GEENEC model is 22 ppb. The acute and chronic
EEC for methamidophos in groundwater is 0.028 ppb. The SCI-GROW model was also used to
estimate ground water concentrations for methamidophos resulting from the application of acephate.
The modeled EEC for methamidophos in ground water from the application of acephate to cotton is
0.005 ppb. Table 3 summarizes the modeled EECs for the respective crop scenarios. The DWLOCs
for methamidophos from all sources are 2.9 for acute exposure and 0.6 for chronic exposure. The
Agency is therefore concerned with possible exposure to methamidophos residues in surface water
sources of drinking water and is requiring confirmatory monitoring data to evaluate actual acute and
chronic concentrations of methamidophos. The Agency does not have risk concerns for exposure to
drinking water from ground water sources.
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Aggregate Risk
' The acute aggregate risk assessment for methamidophos from all sources combines exposure
from food and drinking water sources only. Acute dietary (food) risk estimates are below 100% of the
aPAD for the US population and all population subgroups. Infants is the most highly exposed
population subgroup and has an acute'drinking water level of comparison (DWLOC) of 2.9 ppb.
Based on screening-level model predictions of the remaining supported uses, the acute (peak) drinking
water estimated concentration in surface water is 61.8 ppb which is of risk concern to the Agency. The
. screening-level model predictions of acute concentrations in ground water is 0.033 ppb for'
methamidophos, which is less than fee DWLQC and not of risk concern to the Agency.
' • However, due to the uncertainties and limitations of the model predictions, the Agency believes
that actual acute concentration of methamidophos in surface water is likely to be less than the
DWLGC, To demonstrate Ibis, confirmatory surface water monitoring data is to be generated to
address this risk concern.
Similarly, the chronic aggregate risk assessment for methamidophos combines exposure from
food and drinking water sources only. Chronic dietaiy (food) risk estimates are well'below 100% of
the cPAD for the US population and all population subgroups. Children 1-6 years old is the most highly
exposed population subgroup and result in a chronic DWLOC of 0.9 ppb. Based on screening-level
model predictions of the remaining supported uses, the average (chronic) estimated concentration in
surface water is 3.8 ppb, which is of risk concern to the Agency. Similarly, due to the same
uncertainties and limitations of the model predictions for acute exposure, the Agency also believes that
actual chronic concentrations of methamidophos in surface water is likely to be less than the DWLOC.
To demonstrate this confirmatory surface water monitoring data is to be generated to address the risk
concern.
The screening-level model predictions of acute concentrations in ground water is 0.033 ppb for
methamidophos, which is less than the DWLOC and not of risk concern to the Agency.
Occupational Risk
Occupational exposure to methamidophos is of concern to the Agency, and it has been
determined that a number of mitigation measures are necessary at this time. For the agricultural uses of
methamidophos, several mixer/loader/ applicator risk scenarios currently exceed the Agency's level of
concern (i.e., MOEs are less than 100). EPA believes that most of these risks can be mitigated to an
acceptable level by phasing out use on cotton and with the following label restrictions; use of closed
cabs by applicators; use of enclosed vehicles for Saggers or the use of ground positioning system (GPS)
equipment that negates the need for flaggers for aerial application.; and increased Restricted Entry
Intervals (REIs).
Ecological Risk
3
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Ecological rides are also of concern to the Agency. Hie Agency's assessment suggests the
potential for the liquid formulation to cause acute effects to birds for broadcast applications. The avian
acute RQs range from 0.38 to 6.63. Hie highest avian acute RQ is from nine 1 lb ai/A ground or aerial
applications to tomatoes. For the same use patterns, mammalian acute RQs range from 0.2 to 20.3.
Regarding chronic risk to birds, the RQs range from 2.49 to 32.87. Again the same use patterns
resulted in chronic RQs for mammals ranging from 0.75 to 9.86. All use patterns are of concern to the
Agency for acute and chronic effects to birds and mammals.
Acute risk to freshwater fish and estuarine fish is not of concern for any use patterns, with RQs
ranging from <0.05 to 0.07. The acute high risk, restricted use risk and endangered species risk is of
concern for freshwater invertebrates at the maximum application rate of 1.0 lb ai/A with RQs ranging
from 1.1 to 3.0 and may be of concern for estuarine invertebrates. No chronic risk assessment was
conducted since there are no chronic data for aquatic species.
Because of the toxicity of methamidophos, to help protect terrestrial birds, mammals and
freshwater invertebrates, it is very important to reduce their potential exposure to methamidophos
products that have been applied. In additional to the phase out of the cotton use to mitigate
occupational risks of concern which will also serve to reduce risk to binds and mammals, reductions in
the maximum number of applications allowed per season are needed to reduce risks to birds, mammals
and fresh water invertebrates.
Hie Agency has determined that, with the phase-out of the cotton use and the addition of the
label restrictions and amendments detailed in this document, until the outcome of cumulative risks for all
of the organophosphates has been considered, other currently registered uses of methamidophos may
continue.
The Agency is issuing this Interim Reregi station Eligibility Document (IRED) for
methamidophos, as announced in a Notice of Availability published in the Federal Register. This
interim RED document includes guidance and time frames for complying with any necessary label
changes for products containing methamidophos. Note that there is no comment period for this
document, and that the time frames for compliance with the label changes outlined in this document are
shorter than those given in previous REDs. As part of the process discussed by the TRAC, which
sought to open up the process to interested parties, the Agency's risk assessments for methamidophos
have already been subject to numerous public comment periods, and a further comment period for
methamidophos was deemed unnecessary. 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. With regard to complying with the risk
mitigation measures outlined in this document, the Agency has shortened this time period so that the
risks identified herein are mitigate! as quickly as possible. Neither the tolerance reassessment nor the
reregistration eligibility decision for methamidophos can be considered final, however, until the
4
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emulative risks for all organophosphate pesticides is considered. The cumulative assessment may
result in further risk mitigation measures for methamidopliGS. ¦
5
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L Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (F1FRA) 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.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment of all existing tolerances. The Agency had
decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. It also requires that by 2006, EPA
must review all tolerances in effect on the day before the date of the enactment of the FQPA. FQPA
also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a safety finding in
tolerance reassessment based on factors including an assessment of cumulative effects of chemicals with
a common mechanism of toxicity. Methamidophos belongs to a group of pesticides called
organophosphates, which share a common mechanism of toxicity - they all affect the nervous system by
inhibiting cholinesterase. Although FQPA significantly affects the Agency's reregistration process, it
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.
This document presents the Agency's revised human health and ecological risk assessments; its
progress toward tolerance reassessment; and the interim decision on the reregistration eligibility of
methamidophos. It is intended to be only the first phase in the reregistration process for
methamidophos. The Agency will eventually proceed with its assessment of the cumulative risk of the
OP pesticides and issue a final reregistration eligibility decision for methamidophos.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination mid 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 (TRAQ, which was
composed of representatives from industry , environmental groups, and other interested parties.
In addition to the policy issues that resulted from the TRAC process, the Agency issued, on
Sept. 29,2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from organophosphate pesticides to occupational users. The Worker Risk Mitigation
6
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for Grganophosphate Pesticides PR Notice describes the Agency's baseline approach to managing
risks to handlers and workers who may be exposed to organophosphate pesticides, and the Agency
expects that other types of chemicals will be handled similarly. Generally, basic protective measures
such as closed mixing and loading systems, enclosed cab equipment, or protective clothing, as well as
increased reentry intervals will be necessary for most uses where current risk assessments indicate a
risk and such protective measures are feasible. The policy also states that the Agency will assess each
pesticide individually, and based upon the risk assessment, determine the need for specific measures
tailored to the potential risks of the chemical. The measures included in this interim RED are consistent
with the Worker Risk PR Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistratiori'tolcrance reassessment. Section II provides a profile of the use and usage of the
chemical. Section 11 gives an overview of the revised human health and environmental effects risk
assessments resulting from public comments and other information. Section IV presents the Agency's
interim decision on leregistealion eligibility and ride management Section V summarizes the label
. changes necessary to implement the risk mitigation measures outlined in Section IV. Section VI
provides information on how to access related documents. Finally, the Appendices lists Data Call-In
'(DO) information. The revised risk assessments and related addenda are not included in this .
document, but are available on the Agency's web page www.epa.gov/pesticides/op, and in the Public
Docket.
7
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II. Chemical Overview
A. Regulatory History
Methamidophos was first registered in the United States in 1972 under the trade name Monitor.
It was used principally on potatoes, cotton, and cole crops to control a broad spectrum of insects
through contact, and systemic action inhibiting cholmesterasc. A Registration Standard, which
describes the terms and conditions for the continued registration of methamidophos, was issued for
methamidophos in 1982.
In 1997, the technical registrant, Bayer Corporation, voluntarily cancelled all uses of
methamidophos except for use on cotton, potatoes, and tomatoes (special local need only). In 1998, a
special local needs registration was issued for use on alfalfa grown for seed in California. By December
1999, the registrant had also voluntarily phased-in closed mixing and loading systems for all remaning
uses to address potential worker exposures.
B. Chemical Identification
Methamidophos:
h3cn
o
S I NH,
OCH,
• Common Name;
• Chemical Name:
• Chemical family:
• Case number:
• CAS registry number:
• OPP chemical code:
• Empirical formula:
• Molecular weight:
Methamidophos
0,S-dimethyl phosphoramidothioate
Organophosphate
0043
10265-92-6
101201
C2H8N02PS
141.1
Trade and other names: Monitor
8
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® Basic manufacturer: Bayer Corporation, Vaient U.S A
Methamidophos is a colorless to white crystalline solid with, a strong mercaptan-like odor, and
a melting point of 46.1°C. It is readily soluble (>200 g/L) in water, acetone, dimethylfomamide,
dicMoromethane, and 2-propanoL and is soluble in n-octanol at 50-100 g/L, toluene at 2-5 g/L, and n-
hexane at <1 g/L. The vapor pressure of methamidophos is approximately 1.725 x 10"5 mm Hg.
C, Use Profile
The following information is based on the currently registered uses of methamidophos:
Type of Pesticide; Insecticide/acaricide.
Snmmaiy off Use Sites:
Food/Feed Crop: Cotton, potato, and tomato.
Other Agricultural Sites: None.
Residential: None.
Public Health: None.
Nonfood Crop: ¦ AlMfa grown for seed
Target Pests: Broad spectrum of insects including: aphid, Colorado potato
telle, green peach aphid, lealfaopper, leaflniner, lygus bug, -
stink bug, tomato pinworm, and whitefiy.
Formulation Types Registered:
Technical Grade/Mannfecturer-IJse Product (MUFl: liquid 60-72% ai.
End-Use Product: emulsifiable concentrate (EC) 40% aL
Method and .Rates of Application:
Equipment: . Aircraft, ground sprayer, and sprinkler irrigation.
Method and Rate: Chemigation (potatoes only), high volume spray, (dilute), and low
volume spay (concentrate). Maximum use rate for all crops is 1.0 lb
ai/A. The label allows fcur applications per season on cotton and
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potatoes, and up to nine applications per season on tomatoes.
Timing: Methamidophos end-use products are applied at various times including at-
plant, and foliar timings.
Use Classification: Restricted Use
D. Estimated Usage of Pesticide
Table 1 summarizes the best available estimates for the pesticide uses of methamidophos. These
estimates are derived from a variety of published ami proprietary sources available to the Agency for
1999 and 2000. A &11 listing of all uses of methamidophos, with the corresponding use and usage data
for each site, has been completed and is in the "Quantitative Use Assessment," dated 5-9-2000 and the
"Use and Usage Analysis for Methamidophos," dated November 20,2001, which are available in the
public docket. Approximately 640,000 pounds of active ingredient (lbs ai) of methamidophos are used
annually, according to Agency estimates. Methamidophos use is highest on potatoes (87% of total
methamidophos pounds applied), followed by tomato (8% of total methamidophos pounds applied),
and cotton (5% of total methamidophos pounds applied).
Table 1. Methamidophos Usage Summary in the United States1
Crop
Percent Crop
Treated
Base Acres
T reated (1000
acres)2
Average Number
of Applications
Per Year
Average
Application Rate
(Ibsai/A)
Pounds Active
Ingredient
Applied
(1000 lbs.)
Alfalfa for Seed
(CA only)
50%
33*
1.0
o.a
36
Cotton
2%
288*
1.0
0.3
84
Potatoes
29%
322*
1.7
0.9
520
Tomatoes (Fresh)
15%
18*
2,5
0.6
28
Tomatoes
(Processed)
3%
9*
1.0
0.9
8
'Source: USDA 1999 and 2000 Agricultural Chemical Use (May, 2000, May 2001, July, 2001) and California
Department of Pesticide Regulation, Pesticide Use Report (2000)..
2Base acres treated derived from estimate of acres grown in USDA 1999 rod 2000 Agricultural Chemical Use (May
2000, May 2001, July, 2001).
*Base acres treated for California derived from harvested acreage; other states based cm USDA 2000 Agricultural
Chemical Use.
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1H. Summary of Methamidophos Risk Assessment
The purpose of this summary is to assist the reader by identifying the key features and findings
of these risk assessments, and to better understand the conclusions reached in the assessments.
Following is a list of EPA's revised human health and ecological risk assessments and supporting
m&imatkm that were used to formulate the findings arid conclusions for the organophospfaate pesticide
methamidophos. The listed documents may also be found on the Agency's web page at
www.&oa.gQv/oestieides/oiP and in the public docket.
These risk assessments for methamidophos were presented at a February 3,2000 technical
briefing, which was followed by an opportunity for pubic comment on ride management for this
pesticide. The risk assessments presented here form the basis of the Agency's risk management
decision for methamidophos only; the Agency must consider a cumulative assessment of the risks of all
the OP pesticides before any final decisions can be made.
Human Health Risks
~ Human Health Risk Assessment-Methamidophos Revised Risk Assessment, February 3,
2000.
•, Revised Dietary Exposure and Risk Analyses for the HED Revised Human Health Risk
Assessment, My 19,2000.
• Methamidophos: Addendum to the Revised Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility Decision Document,
September 15,2000.
• Recalculated Tier II Drinking Water EECs for Methamidophos Incorporating the Index
Reservoir and Percent Cropped Area, October 17,2000.
Inwonmental Fate and Ecologies! Effects
* Amended EFED Methamidophos RED Chapter, September 15,1999.
. A, Human Health Risk Assessment
The methamidophos risk assessments are different than those for most organophosphate
pesticides because methamidophos is a metabolite of the organophosphate pesticide acephate.
Consequently, the assessments encompass the risk of methamidophos from applications of
methamidophos only, and from "all sources" which includes applications of acephate. Acute
probabilistic and chronic dietary (food) risk assessments were conducted as well as a qualitative
assessment of the potential exposure to all methamidophos sources through drinking water. EPA
issued is preliminary risk assessments for methamidophos on October 30,1998 (Phase 3 of fee TRAC
..process). In response to comments and studies submitted during Phase 3 and Phase 5, the risk
11
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assessments were updated and refined. Major revisions to the human health risk assessment are listed
below:
* Refinement of the acute dietary (food) risk assessment to use probabilistic (Monte
Carlo) techniques;
* Incorporation of data from USDA's Pesticide Data Program (PDF) into the dietary
(food) risk assessment;
Adjustment to percent crop treated estimates;
Incorporating washing and cooking factors into the dietary (food) assessment;
* Revised anticipated residues were calculated for use in the dietary risk assessment;
* Use of residue data from a potato processing study was incorporated into the dietary
risk assessment;
Information concerning a submitted import tolerance petition for peppers, squash, and
strawberries was incorporated.
* 1999 PDP monitoring data on canned tomatoes was incorporated in the dietary
assessment.
* Use of new toxicologieal endpoints for dermal risk assessment These data affect the
lowest observed effect level, and no observed effect level in the dermal risk
assessments.
Use of three dislodgeable foliar residue studies submitted by Bayer to assess post-
application exposure to agricultural workers, and set restricted entry intervals.
* Recalculated Tier II drinking water EECs incorporating the Index Reservoir and
Percent Cropped Area.
2. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is complete, and that it supports an interim RED for all currently registered uses. Further
details on the toxicity of methamidophos can be found in the February 3,2000 "Human Health Risk
12
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Assessment" and subsequent addenda. A brief overview of the studies and safety factors used for the
dietarv- (food) risk assessment is outlined in Table 2 in this document
b. FQPA Safety Factor
The FQPA Safety Factor (SF) was reduced from lOx to 3x. A weight-of-the-evidence
approach indicated neuropathology in hens and humans reported in the open scientific literature. This
led the Agency to conclude that an FQPA safely fietor is appropriate, in studies from the open
scientific literature, ingestion of methamidophos has been shown to result in delayed peripheral
neuropathy in humans. Similarly, adult hens developed poly neuropathy. The Agency determined that
the lOx factor can be reduced to 3x primarily because: 1) there was no increased susceptibility of the
offspring of rats or rabbits to pre- and/or post-natal exposure 2) a two-generation reproductive toxicity
study in rats showed no increased sensitivity in pups when compared to adults 3) the toxicology
database is complete; and 4) the dietaiy food exposure assessment does not underestimate the potential
exposure for infants and children from residues in food. However, based on tins evidence, the
requirement of a developmental neurotoxicity study has been triggered. This study will in turn provide
additional data (e.g., potential increased susceptibility, and effects on the development of the fetal .
nervous system, etc.). More information can be found in the document "FQPA Safety Factor
Recommendations for the Qiganophosphatesdated August 6, 1998.
e. Population Adjusted Dose (TAB)
The PAD is a term that characterizes the dietaiy 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). The RfD is .calculated by taking the no observed adverse effect level
(NOAEL) from an appropriate study and dividing it by an uncertainty factor (i.e., NOAELAJF). A risk
estimate that is less than 100% of the acute PAD (aPAD) or chronic PAD (cPAD) does not exceed
flie Agency's risk concern. In the case of methamidophos. the FQPA safety factor is 3x; therefore the
acute and chronic PADs are equivalent to the acute and chronic RIDs divided by 3, respectively. The
aPAB for methamidophos is 0.001 mgfcg/day. The cPAD for methamidophos is 0.0001 mg/kg/day.
The basis for the aPAD and the cPAD are summarized in Table 2 below.
Expcscrs ' [- '¦ Dose
Scenario |
Enipoiut
¦ Toslcfllogy Study
Iff
¦ FQPA
Safety
Factor
PAD
(mgflsg/ilay)
Acute dietary 1 NOAEL=0.3
1 msfe/day
• LOAEL = 0.7
I mgfe/day
Plasma,
eiythroeyteand
brain
choliiiesterase
inhibition.
Acute neurotoxicity study in
rats
(MRIDs 43025001,
43345S01)
100
'3
0.001
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Chronic dietaiy
NOAEL = 0.03
Brain
8- week subchronic oral
100
3
0.0001
mg/kg/day
cholinesterase
toxicity cholinesterase study
inhibition.
in rat (MMD 41867201)
LOAEL = 0.06
nig/kg/day
d. Exposure Assumptions
The Agency conducts dietary (food) risk assessments using the dietary exposure evaluation
model (DEEM™), which incorporates consumption date generated in USDA's continuing survey of
food intakes by individuals, 1989-1992, For the assessment of dietary (food) exposure to residues of
methamidophos resulting from the use of methamidophos, monitoring data generated through the
USDA Pesticide Data Program (PDP) for potatoes and tomatoes, and through the Food and Drug
Administration (FDA) Surveillance Monitoring Program for peppers, squash, and strawberries were
used. Anticipated residue values from crop residue field trial studies, and percent crop-treated data
were used for cotton. For the assessment of dietary (food) exposure to residues of methamidophos
resulting from the me of acephate, PDP or FDA monitoring data were used for succulent beans,
cauliflower, celay, lettuce and peppers. Anticipated residue values from crop residue field trial studies,
and percent crop-treated data were used for dry beans, Brussels sprouts, cotton, cranberries,
macadamia nuts, mint, peanuts and soybeans.
For acute probabilistic dietaiy risk assessments, the entire distribution of single-day food
consumption events is combined with a distribution of residues to obtain a distribution of exposure in
mg/kg/day. Chronic dietary (food) risk assessments use the three-day average of consumption for each
subpopulation combined with residues in commodities to determine average exposure in mg/kg/day.
For probabilistic assessments, the Agency regulates at the 99.9th percentile of exposure. Both
assessments included the dietaiy (food) risk from methamidophos exposure from use of
methamidophos and from the use of acephate.
Valent U.S.A. Corporation has submitted an import tolerance petition in support of uses of
methamidophos on squash, strawberries and peppers. There is an existing tolerance for
methamidophos on peppers, but none has been established for the latter two commodities. The dietary
risk assessment includes these proposed uses. Otherwise, these proposed tolerances are not
addressed in this BRED.
e. Food Risk Characterization
Generally, a dietary (food) risk estimate that is less than 100% of the acute or chronic
Population Adjusted Dose does not exceed EPA's risk concerns. Acute dietaiy (food) exposure to
methamidophos from applications of methamidophos alone, and from "all sources" (applications of
methamidophos and acephate) result in risk estimates that are below the Agency's level of
concern—that is, less than 100% of the acute PAD is used. For example, for exposure resulting from
14
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applications of methamidophos alone, for the most exposed subpopulation. children 7-12 years old, the
percent acute PAD value is 33% at the 99.9th percentile of exposure from consumption of food alone.
For exposure resulting from applications of methamidophos from "all sources", for the most exposed
subpopulation, all infants, the percent acute PAD value is 76% at the 99.9th percentile of exposure
from consumption of food alone.
¦ Chronic dietary (feed) exposure estimates are also below the Agency's level of concern for all
subpopulations. For the most highly exposed subpopulation, children 1-6 years old, the percent
chronic PAD values are 15% for methamidophos alone and 37% when including methamidophos
residues from the application of aeephate, from consumption of food alone.
2. Dietary Risk from Drinking Water'
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate these risks. Modeling is ¦
considered to be an unrefined assessment and provides a high-end estimate of risk. Very limited -
monitoring data is available for methamidophos therefore, modeling was used to estimate drinking water
risks from these sources.
The GENEEC and PRZM-EXAMS models were used to estimate surface water
concentrations, and SCI-GROW was used to estimate groundwater concentrations. All of these are
considered to be screening models, with fee PRZM-EXAMS model being somewhat more refined than
.the other two.
As in the dietary risk assessment for food, separate drinking water risk assessments were
conducted for both exposure to methamidophos as a result of the application of methamidophos and
exposure to methamidophos from all sources including the application of aeephate.
Although the environmental fete data base for methamidophos is not complete, supplemental
information from ungradable laboratory studies indicate that methamidophos is not persistent in aerobic
environments but may be persistent in anaerobic aquatic environments where it will be associated with
the aqueous phase. No acceptable data, are available on the behavior of methamidophos under field
conditions, but information from acceptable terrestrial field dissipation studies for aeephate indicated
that methamidophos is not persistent
a. Surface Water
The Her E PRZM-EXAMS screening model is used to estimate upper-bound environmental
concentrations (EECs) in drinking water derived from surface water. This model, in general, is based
on more refined, less conservative assumptions than, fee Tier I GENEEC screening model Acute
modeled EECs for methamidophos in surface water from fee application of methamidophos alone range
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from 29 ppb to 48 ppb, depending on the crop site. Chronic modeled EECs for methamidophos in
surface water from the application of methamidophos alone range from 3.9 ppb to 6.9 ppb, depending
on the crop site.
The Agency also used the recently implemented Index Reservoir (IR) and Percent Crop Area
(PCA) modifications to the Tier IIPRZM-EXAMS model to calculate upper-bound EECs for
methamidophos in drinking water derived from surface water. Applying the IR and PCA modifications,
acute modeled EECs for methamidophos in surface water from the application of methamidophos alone
range from 28.6 ppb to 61.8 ppb depending on the crop site. Chronic modeled EECs for
methamidophos in surface water from the application of methamidophos alone range from 1.5 ppb to
3.8 ppb, depending on the crop site.
The surface water model assumes methamidophos applications are made at the maximum rate
for each crop on the current label, using the labeled methods of application. The model results are also
based on four applications per season with a seven day retreatment interval. The lack of acceptable
aerobic aquatic metabolism data increase the uncertainty of the chronic estimated environmental
concentrations (EECs).
To estimate the potential exposure to methamidophos from the application of acephate, the
Agency relied upon the Tier IGENEEC screening model. A higher-tiered model was not used in this
case due to the high level of uncertainty surrounding any estimate of 1he decay rate for acephate and the
transformation rate of acephate to methamidophos which are needed to use the PRZM-EXAMS
model. The acute modeled EEC for methamidophos in surface water from the application of acephate
to cotton is 22 ppb. The chronic modeled EEC for methamidophos in surface water from the
application of acephate to cotton is 12 ppb. This analysis assumes a 25% conversion efficiency from
acephate to methamidophos at time of application resulting in the equivalent of six applications at 0.25
lb methamidophos/aiiA on cotton. EECs for other crops were not developed.
For the purposes of assessing drinking water risks from exposure to methamidophos from all
sources (i.e, including both methamidophos and acephate applications) the Agency will rely upon the
model estimates generated using the PRZM-EXAMS model with the Index Reservoir (IR) and Percent
Crop Area (PCA) modifications described above which are based upon the application of
methamidophos alone. The Agency believes that the conservative default PCA used for the scenario
with the highest EEC (potatoes in ME) would most likely account for methamidophos residues from
both methamidophos and acephate applications in a given watershed. For this scenario, the default
PCA value of 0.87 was used to calculate the EEC. This assumes that 87% of the watershed being
evaluated is cropped in potatoes and/or other crops that methamidophos can be applied to. In this
particular case, it is estimated that 65,000 acres of potatoes are grown in the state of Maine each year.
Cotton is not grown in Maine and there is not a SLN for tomatoes there so all methamidophos use in
that state would be cm potatoes. If it was assumed that all that acreage fell into any one of the nine
watersheds in Maine as a worst-case scenario, the range of PCA values would likely be 0.04 to 0.16
or 4% to 16%, significantly lower than the 87% assumption. The effect of the PCA value on EECs has
16
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a linear relationship. Consequently, using these values would reduce EECs by a factor of 5 to 20.
Further, the main crop uses of acephate (beans, cotton, Lettuce and tobacco) are either not grown in
Maine or are not likely to have significant acreage. Therefore, additional contribution of
methamidophos residue from the application of acephate in this scenario is very unlikely. Even though
this analysis has not been deemed to be sufficient to change the PC A quantitatively, it does support the
belief that this EEC likely provides a sufficiently protective estimate of exposure to methamidophos
from all sources in drinking water. Further, the information is not currently available to enable the
Agency to use a Tier II model to estimate concentrations of methamidophos fiom fee application of
acephate, as described above, and it is not considered appropriate to combine the results of a Tier H
assessment (methamidophos applications) with the results of a Tier I assessment (acephate
applications).
Monitoring for methamidophos in surface water is limited. No residues were detected in the
available samples (328 samples primarily from Florida and Mississippi) but the limits of detection for
this sampling are uncertain and it is unclear if these samples were taken in areas where methamidophos
was being used. Given these limitations, the existing surface water monitoring database cannot be used
to estimate concentrations of methamidophos in surface water. The U.S. Geological Survey (USGS) in
its National Water Quality Assessment (NAWQA) program is not currently analyzing for
methamidophos.
. b. Ground Water
The Tier I screening model, SCI-GROW, was used to .estimate drinking water concentrations
derived from groundwater. The acute and chronic EEC for methamidophos in groundwater is 0.028
ppb. Hie ground water modeling assumes the maximum yearly total application of methamidophos'
(nine applications at 1.0 Ib/ai^A on tomatoes in Florida) per the current iabels. Methamidophos is not
expected to leach significantly to groundwater given that it is not persistent under aerobic conditions.
This expectation is reflected in the results of the model. • Further, a majority of use areas will have
ground water that is less vulnerable to contaminatioE than that in areas used to derive the SCI-GROW
estimate. Very limited ground water monitoring data for methamidophos is available. Four detections
were recorded in these date which were collected between 1984 and 1993.
, Hie SCI-GROW model was also used to estimate ground water concentrations for
methamidophos resulting from the application of acephate. Hie modeled EEC for methamidophos in
ground water fiom the application of acephate to cotton is 0.005 ppb. This analysis assumes a 25%
conversion efficiency fiom acephate to meSiamidophos at time of application resulting in the equivalent
of six applications at 0.25 lb methamidophos/ai/A on cotton. EECs for other crops were not
developed.
Since fee same model was used to develop both the EECs iron methamidophos applications
and methamidophos resulting from applications of acephate, the Agency has decided to combine the
estimates for the purposes of assessing drinking water risks from exposure to methamidophos from all
17
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sources.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water containing pesticide residues
permitted in the dirt, EPA first looks at how much of the overall allowable risk is contributed by food
(and if appropriate, residential uses) then determines a "drinking water level of comparison' ;(D WLOC)
to determine whether modeled or monitoring levels exceed this level. The Agency uses the DWLOC
as a surrogate to capture risk associated with exposure from pesticides in drinking water. Hie
DWLOC is the maximum concentration in drinking water which, when considered together with dietary
(food) exposure, does not exceed a level of concern.
Hie results of the Agency's drinking water analysis are summarized here. Details of this
analysis, which used screening models, are found in the HED Human Health Risk Assessment dated
February 3,1999, the EFED Environmental Risk Assessment dated September 15,1999, and the
Recalculated Tier II Drinking Water EECs for Methamidophos Incorporating the Index Reservoir and
Percent Cropped Area, October 17, 2000.
For acute risk, surface water EECs exceed the acute DWLOCs for all subpopulations (Table
3). Even if it is assumed that there are no food exposures to methamidophos, drinking water alone,
based on model estimates, would result in exeeedences of the risk cup, particularly fa* infants and
children. Ground water EECs do not exceed the acute DWLOCs for any subpopulations. Therefore,
the Agency does not have a risk concern for ground -water sources of dietary exposure for the general
U.S. population or the most highly exposed subpopulation. The table below presents the calculations
for the acute drinking water assessment.
Table 3. Summary of DWLOC Calculations for Acute Risk
Population
Subgroup
aPAD
(mg/kg/day)
Food Exposure
(mg/kg/day)
Available
Water
Exposure
(mg/kg/day)
DWLOC
(ppb)
Maximum
Surface Water
EECs
(ppb)
Maximum
Groundwater
EECs
(PPb)
Methamidophos
U.S. Population
0.001
0.000269
0.000731
25.6
61.8
0.028
Children 7-12
years old
0.001
0.000334
0.000684
6.8
61.8
0.028
Methamidophos from all Sources
li.S. Population
0.001
0.000429
0.000571
20
61J
0.033
All Infants
0.001
0.000762
0.000238
2.4
61.8
0.033
For chronic risk, surface water EECs slightly exceed the chronic DWLOCs for all
18
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subpopulations (Table 4). Ground water EECs do not exceed the chronic DWLOCs for any
subpopulations. Therefore, the Agency does not have a risk concern for ground water sources of
dietary exposure for the general U.S. population or the most highly exposed subpopulation. The table
below presents the calculations for the chronic drinking water assessment
Table 4, Summary of DWLOC Calculations for Chrome Risk
Population
Subgroup
cPAB
(mg/kg/fiay)
Food Exposure 1 Available Water DWLOC
(rng/kg'day) 1 Exposure. ¦ (ppb)
J : (Hig/kg/day) ,
Masiraam
Surface Wafer
EECs
(H*)
Maximum
Groundwater
EECs
•'(ppb)
Mclfcajnidophcs
XJ.S. Population
0.0001
0.000007
0.000093
3.3
3.8 .
0.028
Children 1-6
_ years old
0.0001
0.000015
0.000085
0.9
3.8
0.028
MeiharnMepisos from *3] Sonrcss
U.S. Population
0.0001
0.000023
0.000077 3
' 3.8
0.033
Children 1-6
years old
0.0001
0.00003?
0.000063 0.6
3.8
0.033
The acute and chronic dietary risks from drinking water exposure are above the Agency's level
of concern for most subpopulations.
3. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (toed and ¦
drinking water routes) and any non-occupational exposures (residential use). Acute and chronic
aggregate risk assessments were conducted for methamidophos. Methamidophos is not registered for
use in residential settings. Previously, acephate had numerous residential, recreational and institutional
uses which were evaluated in the acephate IKED. To mitigate risks of concern, acephate use in these
settings have been limited to indoor use in institutional settings such as schools and hospitals, use on
ornamentals In the residential settings, spot or mound treatments for fire ant control, and use on golf
course turf. The risks associated with the degradation of acephate to methamidophos for these uses
were evaluated in the acephate IKED and were found to be negligible. Therefore, aggreiate short-term
exposures were not estimated. Results of the aggregate risk assessment are summarized here, and are
discussed in the methamidophos human health risk assessment
The Agency was only able to quantify food sources of dietary exposure to methamidophos
because dieiaiy exposures through drinking water have only been estimated using models. Neither
adequate groundwater or surface water monitoring data were available to estimate potential drinking
water exposures to methamidophos.
Acute Aggregate Risk Assessment: Potential acute dietaiy risks from food sources alone do not
exceed the Agency's level of concern. The most exposed subpopulation, all, infents, consume 76% of
19
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the acute PAD at the 99.9th percentile of exposure, based on highly refined exposure estimates.
Further, potential drinking water risks from exposure to water from ground water sources does not
exceed the acute DWLOCs and, therefore, do not exceed the Agency's level of concern. However,
when drinking water exposure concentrations, derived from surface water models, are added to the
acute dietary risk assessment, the potential exists for acute dietary exposures through drinking water
that exceed the acute DWLOCs, resulting in acute aggregate risks of concern.
Chronic Aggregate Risk Assessment: In the case of the food component of the chronic
aggregate risk assessment, risks are well below the Agency's level of concern. No more than 37% of
chronic PAD is consumed for children 1-6. Further, potential drinking water risks from exposure to
water from ground water sources does not exceed the chronic DWLOCs and, therefore, do not
exceed the Agency's level of concern. However, based on modeled estimates of methamidophos
concentrations in surface water, the potential exists for chronic dietary exposures through drinking
water that exceed the chronic DWLOCs, resulting in chronic aggregate risks of concern.
4. Occupational and Residential Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Methamidophos is a restricted use pesticide and has no uses in
residential areas. However, methamidophos is a degradant of the pesticide acephate which does have
residential uses. Methamidophos residential exposure risk resulting from acephate applications in
residential areas was evaluated in the Interim Reregistration Eligibility Decision for Acephate dated
September 30,2001. Occupational handlers of methamidophos include: individual farmers or growers
who mix, load, and/or apply pesticides, professional or custom agricultural applicators. Risk for all of
these potential ly exposed populations is measured by a Margin of Exposure (MOE) which determines
how close the occupational or residential exposure comes to a No Observed Adverse Effect Level
(NOAEL). Generally, MOEs greater than 100 do not exceed the Agency's risk concern.
a. Toxicity
The toxicity of methamidophos is integral to assessing the occupational risk. All risk
calculations are based on the most current toxicity information available for methamidophos, including a
21-day dermal toxicity study. The toxicological endpoints, and other factors used in the occupational
and residential risk assessments for methamidophos are listed below. Due to the use patterns of
methamidophos, long-term exposure is considered highly unlikely.
Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessments for Methamidophos
Route and Duration
Toxicological Endpoint and Dose
Study
Absorption
of Exposure
Factor
20
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Short-Term Dermal
NOAEL = 0.745 mg/kg/day,
LOAEL = 11.2, mg/kg/day, based an plasma, red
blood cell, and biaio chdinestetase inhibition
21-day dermal
toxicity in rats
NA
Intermediate-Term
Derma!
NOAEL = 0.745 mg/kg/day,
LOAEL = 11.2, mg/kg/day, based on plasma, red
blood cell, and brain cholinesterase inhibition
21-day denaal
toxicity in rats
' NA
Short-Term.
Inhalation
NOAEL = 0.001 mg/I,
LOAEL=0.005 mg/l based on plasma, red Mood
cell, and brain cholinesteiase inhibition
90-day inhalation
toxicity study-rats
" NA
Intermediate-Term
Inhalation
NOAEL = 0.001 mg/L
LOAEL=0.005 mg/I, based on plasma, red Hood
ceil, and tain cholinesterase inhibition
90-day mhalation
toxicity study-rats
NA
Methamidophos is acutely toxic, causing death to laboratory animals shortly after exposure to
relatively low oral, dermal, or inhalation doses. Methamidophos is only moderately irritating to the eyes
and mildly irritating to fee skin. Death and other signs of systemic toxicity occurred shortly after dermal
or ocular application. These findings suggest that methamidophos is rapidly absorbed via these routes.
Table €, Acute Tosirily Profile for Occupational Exposure for Methamidophos
Study Type (MBID)
Results
Toslclty Category
Acute Oral-Rat (00014044)
ID J0=15.6 mg/kg cf
LD^B.O nig/kg ?
I
Acute Dermal-Rabbit (00014049)
ID 50=118 mg/kg tf
I
Acute Inhalation-Rat (00148449)
LC50=0.052-0.079 mg/I cf
LCJ(f=O.O62-0.128 mg/I £
I
Primaiy Eye Lritation-Rabbit (00014221)
Corneal opacity and pannus
present in 2/6 rabbits for 10 days
post-treatment. One death.
I
Primary skin imtafion-Rabbit (00014220)
PIS =0.6. Test material was lethal to
5/9 animals within. 24 his. of
treatment. ,
I
Dermal Sensitizadcn-Guinea Pig (00147929)
Not a skin sensitizer.
NA
b. Exposure
Three chemical-specific dislodgeable foliar residue studies that were submitted to the Agency
by fee technical registrant were used to evaluate post-application exposures. Chemical-specific '
exposure data for handlers were not available for methamidophos, so risks to pesticide handlers were
assessed using date from the Pesticide Handlers Exposure Database (PHED). In addition, standard
assumptions about average body weight, work day. area treated daily and volume of pesticide handled
were used to calculate risk estimates. The quality of fee data and exposure factors represents the best
21
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sources of data currently available to the Agency for completing these kinds of assessments. The
application rates are derived directly from methamidophos labels. The exposure factors (e.g., body
weight, amount treated per day, protection factors, etc.) are all standard values that have been used by
the Agency over several years, and the PHED unit exposure values are the best available estimates of
exposure. Some PHED unit exposure values are high quality while others represent low quality, but are
the best available data. The quality of the data used for each scenario assessed is discussed in the
Human Health Assessment document for methamidophos, which is available in the public docket.
Anticipated use patterns and application methods, range of application rates, and daily amount
treated were derived from current labeling. Application rates specified on methamidophos labels range
to a maximum of 1.0 pounds of active ingredient per acre in agricultural settings. The Agency typically
uses acres treated per day values that are thought to represent eight hours of application work for
specific types of application equipment.
Occupational handler exposure assessments are conducted by the Agency using different levels
of personal protection. The Agency typically evaluates all exposures with minimal protection and then
adds additional protective measures using a tiered approach to obtain an appropriate MOE (i.e., going
from minimal to maximum levels of protection ). The lowest suite of personal protective equipment
(PPE) is baseline PPE. If required (i.e., MOEs are less than 100), increasing levels of risk mitigation
PPE are applied. If MOEs are still less than 100, engineering controls (EC) are applied. The levels of
protection that formed the basis for calculations of exposure from metham idophos activities include :
Long-sleeved shirt and long pants, shoes and socks.
Baseline + chemical resistant gloves and a respirator if risk is driven by
inhalation.
Coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical footwear plus socks, chemical resistant headgear for
overh ead exposures, and a respirator if risk is driven by inhalation.
Engineering controls such as a closed cab tractor for application
scenarios, or a closed mixing/loading system such as a closed
mechanical transfer system for liquids. Some engineering controls are
not applicable for certain scenarios (e.g., for handheld application
methods there are no known devices that can be used to routinely
lower the exposures).
For methamidophos, since the same toxicologieal endpoint and uncertainty factors are being
used for both short-term and intermediate-term (1-30 days to several months) exposure durations, both
risk estimates are identical. Although information is not available to determine what percentage of
applicators apply methamidophos continuously for more than 30 days, it is believed to be a very small
segment of commercial applicators.
c. Occupational Handler Risk Summary
Inhalation and dermal exposure to methamidophos can result from occupational use. The
Baseline:
Minimum PPE:
Maximum PPE:
Engineering controls:
22
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Agency .assessed dermal and inhalation risks (MGEs) for each crop currently registered for
methamidophos. Since the toxicologlca! end-points used for dermal and inhalation exposures are tie
same; plasma, red blood cell, and brain cholinesterase inhibition, the MOEs for each route of exposure
were combined to create a single MOE for each scenario. For methamidophos, occupational MOEs
greater than 100 are not of risk concern to the Agency.
1) Agricultural Handler Risk
EPA has determined that there are potential exposures to mixers, loaders, applicators, or other
Handlers during typical use-pattems associated with methamidophos. All the MOEs in the tables below
are based on combined dermal and inhalation MOEs. The scenario numbers correspond to fee
scenario numbers detailed and discussed in Appendix A of the Occupational and Residential Exposure
Chapter. The anient labels require use of a diy-coupling mixtagtading system. Based on the use
patterns, five major ensure scenarios (each assessed at the same maximum application rate of 1.0 lb
ai/A) were identified for methamidophos:
(la) mixing/loading of liquid formulation for aerial application and chemigction (potato'
only); . •
(lb) mkin^toading of liquid formulation for groundboom application;
(2) applying sprays with an aircraft;
(3) applying sprays with groundboom equipment; and
* (4) flagging aerial spray applications.
• As summarized in Table 7, occupational risks are of concern (i.e., MOEs < 100) for most
scenarios, even when maximum PPE are utilized. Handler risks are also of concern for many scenarios
with engineering controls. Engineering controls are considered to be the maximum feasible mitigation.
It is notable feat dermal exposures are driving the Agency's risk concern for fee occupational scenarios
in question rather than inhalation exposures especially in the case of applicators and flaggers. For
example, the MOE of 51 for groundboom applicators for cotton using enclosed cabs is composed of
an MOE of 53 for the dermal component and an MOE of 2198 for the inhalation component
Table 7. Agricultural Uses: Remaining Risk Concerns
(combined dermal & Inhalation MOEs)
Total MOEs for Short- and
¦¦¦•¦lirtemetBale-Tenm '-.Risks
fapcsure Scenario ¦¦ .1 Crop
Area Treated
(A/day) ¦
Baseline
-Mm. ¦'
PPE
Max.-
iPPE'
Eaginesnss
. Controls...
Miser/Loader
(ia) Mixitag/loa&ig liquid foimulation for
aerial application or ctanigafion
Cotton/Alfalfa
1200
0.015
1.8
2.5
5
Potato/Tomato
350
0.052
6.3
8.7
17
(lb) Mixing/loafing liquid formulation for
grornidboom application
Cotton/Alfalfa
200
0.090
11
¦ 15
30
Potato/Tomato
80
0.23
28
38
74
Applicator ¦
23
-------
(2) Applying sprays with an aircraft
Cotton/Alfalfa
1200
NA
NA
NA
8.4
Potato/Tomato
350
NA
NA
NA
29
(3) Applying sprays with groundboom
equipment
Cotton/Alfalfa
200
16
18
23
51
Potato/Tomato
80
41
46
59
128
Fiagger
(4) Flagging aerial spray applications
Cotton/Alfalfa
1200
3.7
3.6
3.9
183
Potato/Tomato
350
13
12
14
626
2) Post-Application Occupational Risk
The Agency also assessed post-application risks to workers who may be exposed to
methamidophos when they enter previously treated fields, because their skin may contact treated
surfaces. Exposures are directly related to the kind of tasks performed. EPA examines the amount of
pesticide residue found on the workers over time from various studies. The Agency evaluates this
information to determine the number of days following application feat must elapse before the pesticide
residues dissipate to a level where worker MOEs equal or exceed 100 while wearing baseline attire.
Baseline attire is defined as long-sleeved shirt, long pants, coveralls, shoes and socks. Based on the
results of the post-application worker assessment the Agency establishes restricted entry intervals
(REIs) before workers may enter treated areas. At present, the Worker Protection Standard
designates the REI to be 48 hours, or 72 hours in regions where the annual rainfall is less than 25
inches.
The Agency completed a post-application exposure assessment for methamidophos for the
following scenarios: irrigating, scouting, thinning, and weeding immature plants for cotton, potatoes and
tomatoes; irrigating, scouting, and weeding mature plants for potatoes and tomatoes; and pruning,
staking, tying and hand harvesting for tomatoes. The dermal NOAEL of0.745 mg/kg/day based on a
21-day dermal toxicity study in rats (Table 5) was used to assess potential dermal exposure to workers
re-entering treated fields. The post-application assessment is also based on 8 hours of woricer daily
exposure and the default transfer coefficients (Tcs) shown in Table 8. Also, three chemical-specific
dislodgeable foliar residue (DFR) studies were conducted for methamidophos which were used to
determine the DFR values used in conducting the post-application risk assessment.
For post-application risks to methamidophos, an MOE of 100 or greater is not of concern to
the Agency. Table 8 summarizes the occupational post-application risks following foliar applications of
methamidophos. In summary, except for methamidophos use on cotton, which resulted in a MOE
>300 within one day after being treated, all crops are of post-application risk concern with REIs as
high as 18 days after being treated, such as foliar use of methamidophos on tomatoes in Florida.
Table 8. Occupational Post-application Risks from Foliar Applications of Methamidophos
Crop
Task
Transfer Coefficient
DAT* where MOE >
{cmVhr)
100
24
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Cotton
Irrigating, scouting, thinning, and weeding immatars plants
100
DAT0
Potato
fcrigating. scouting. thinning. and weeding immature plants
300
DAT 4 (KA)
DAT 1 (MO)
DAT 2 (WA)
Irrigating and scouting mature plants
1500
DAT 11 (KA)
DAT 4 (MO)
DAT 7 (WA)
Tomato
Irrigating, scouting thinning, and weeding immature plants
500
DAT 12 (FL)
DAT 4 (CA)
DAT 6 (GA)
Irrigating and scouting mature plants
. 700
DAT 15 (FL)
DAT 5 (CA)
DAT 8 (GA)
Hand harvesting, pruning, staking, tying
1000
DAT 18 (FL)
DAT 7 (CA)
DAT 9 (GA)
* DAT = Day after treatment
B. Environmental Risk Assessment
A summery of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see Amended EFED Methamidophos
RED Chapter, September 15,1999, available in the pubEc docket. The only revision to this p ublicly
available document is a revised drinking water assessment discussed in the dietary risk section above.
1, .Environments! Fate and Transport
Although the environmental fete database for methamidophos is not complete, supplemental
information from upgradable laboratoiy studies indicate that methamidophos is not persistent in aerobic
environments but may be persistent in anaerobic aquatic environments where it will be associated with
the aqueous phase. No acceptable data are available On the behavior of methamidophos under field
conditions, but information fiom acceptable terrestrial field dissipation studies for aeephaie indicate that
methamidophos is not persistent
Aerobic soil metabolism is the main degiadative process for methamidophos. Methamidophos
degraded with a calculated half-life of 14 hoi® in a sandy loam soil at exaggerated applications rates.
Its major degsadates also rapidly degrade in soil (half-life < four days). Methamidophos
photodepades .rapidly on soil (half-life of 63 hours) but photodegrades very slowly in sterile aqueous
solutions (half-life of > 200 days) and is stable against hydrolysis under acidic conditions. .
Laboratory studies show that methamidophos is very soluble and veiy mobile. The
methamidophos degradate DMPT is also expected to be very mobile. Because methamidophos and its
degradate are not persistent under aerobic conditions, Utile methamidophos residue could be expected
to leach to groundwater. Volatilization fiom soil water is not expected to be a major route of
25
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dissipation for methamidophos because of its rapid metabolism in soil and its calculated Henry's
constant of 1.6 x 10" mole/m3.
2. Ecological Risk Assessment
The Agency's ecological risk assessment compares toxicity endpoints from ecological studies
to estimated environmental concentrations (EEC's) based on environmental fete characteristics and
pesticide use date. To evaluate the potential risk to nontarget organisms from the use of
methamidophos products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to
the toxicity endpoint values, such as the median lethal dose (LD50) or the median lethal concentration
(LC5o). These RQ values are then compared to the Agency's levels of concern (LOCs) which
indicates whether a chemical, when used as directed, has the potential to cause undesirable effects on
nontarget organisms. In general, the higher the RQ the greater the concern. When the RQ exceeds the
LOG for a particular category (e.g. endangered species), the Agency presumes a risk of concern to
that categoiy. The LOCs and the corresponding risk presumptions are presented in Table 9.
Table 9. LOCs and Associated Risk Presumptions
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOC of 0.5,
Acute risk
The acute RQ >LOC of 0.2,
Risk that may be mitigated through restricted use
The acute RQ > LOC of 0.1,
Acute effects may occur in Endangered species
The chronic RQ > LOC of 1
Chronic risk and
Chronic effects may occur in Endangered species
Fish and Aquatic Invertebrates
The acute RQ> LOC of 0.5
Acute risk
The acute RQ > LOC of 0.1
Risk that may be mitigated through restricted use
The acute RQ >LOC of 0.05
Acute effects may occur in Endangered species
The chronic RQ > LOC of 1
Chronic risk and
Chronic effects may occur in Endangered species
Plants
The RQ > LOC of 1
Acute risk
The RQ > LOC of 1
Acute risk and endangeied plants may be affected
a. Ecological Hazard Profile
Amian/Mammallam
Basal on a review of the available toxicity database, data for birds showed methamidophos to
be highly to very highly toxic for acute oral exposure and slightly to very highly toxic for subacute
dietary exposure. Table 10 summarizes selected acute toxicity information for birds.
26
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Table 10. Aente Oral Togieity to Birds
Species ¦
I J>K (mg/kg).
Toxicity Category
Acute Oral (Singls dose by garage)
Mallard Back
8.48
Very highly toxic
Northern Bobwhite Quail
8
Very highly toxic
Common Crackle
6.7
Veiy highly toxic
Dade eyed Junco
8
Very highly toxic
Subacute dietary1 (five days of treated feed)
Mallard Duck
847.7
Moderately toxic
Northern BobwMte Quail
42
Veiy highly toxic
Hie effects in avian reproduction testing included reduced egg thickness. Table 11 summarizes
the Jesuits of the chronic toxicity tests for avian species.
Table 11. Avian Reproductive Toxicity
Spsciss/
NOEC (ppis ai)
LOEC (ppm ai)
Study Duration
LOEC Endposnis
Northern bobwhite
3
5
Egg thickness
Mallard dock
>15
>15
No Effect ;
Wild mammal testing is not required for methaimdophos. Rat toxicity values obtained from fee
Agency's Health Effects Division (HED) substitute for wild mamma] testing. Acute and chronic rat
toxicity data relevant to ecological effects show that mettanidopfaos is highly toxic to small mammals on
an acute oral and dermal basis and is considered highly toxic to bees.
Aquatic
Data for freshwater fish showed methamidoplios to be slightly toxic for acute exposure. For
freshwater aquatic invertebrates, data indicated that metfcamidophos is veiy highly toxic for acute
exposure. Data for esfaaitne and marine fish showed methamidophos to be moderately toxic for acute
exposure. For estaarine and marine aquatic invertebrates, data indicated that methasiidophos is slightly
to very highly toxic for acute exposure. Data was either not required (fish) or unavailable
(invertebrates) to assess the chronic effects of methamidophos. Table 12 summarizes invertebrate
toxicity.
Table 12. Accte Toxicity to Aquatic Invertebrates
Species,
Study Type
.ECja^jpmai) ......
TosMty Category
48-hr ¦
' 96-hr
Freshwater
27
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Table 12. Acute Toxicity to Aquatic Invertebrates
Waterflea
0.026
-
Very highly toxic
Estuarine/Marine
Oyster
-
36
Slightly toxic
Blue Shrimp
-
0.00016
Very highly toxic
Mysid Shrimp
-
1.05
Moderately toxic
b. Risk to Birds and Mammals
EPA uses models to estimate exposure of nontarget plants and animals to methamidophos. For
terrestrial birds and mammals, the Agency first estimates initial levels of pesticide residues on various
wildlife food "items. Acute and chronic rides to birds and mammals were predicted for the liquid
formulations of methamidophos.
The Agency's assessment suggests the potential for the liquid formulation to cause acute effects
to birds for broadcast applications. The avian acute RQs range from 0.38 to 6.63. The highest avian
acute RQ is from nine I lb ai/A ground or aerial applications to tomatoes. Regarding chronic risk to
birds, the RQs range from 2.49 to 32.87. Table 13 summarizes the risk quotients for birds.
Table 13, Avian Acute and Chronic Risk Quotients Based on Bobwhite Quail
Number of Applications
Diet
I1C (ppm)
Risk Quotient
Ma*.
Mean
Acute
Chronic
Tomatoes at 5 app at 1.0 lb ai
Short grass
256
91
6.10
30.22
Tall grass
117
38
2.79
12.80
Broad Leaf
144
48
3.43
16.00
Seed Fruit
16
7
0.38
2.49
Tomatoes at 9 app at 1.0 lb ai
Short grass
278
99
6.63
32.87
Tall grass
128
42
3.04
13.92
Broad Leaf
157
52
3.73
17.40
Seed Fruit
17
8
0.41
2.71
Potatoes/Cotton at 4 app at 1.0 lb
ai
Short grass
256
91
6.10
30.22
Tall grass
117
38
2.79
12.80
Broad Leaf
144
48
3.43
16.00
Seed Fruit
16
7
0JS
2.49
For the same use patterns, mammalian acute RQs range from 0.2 to 20.3 and in chronic RQs
for mammals ranging from 0.75 to 9.86. All use patterns are of concern to the Agency for acute and
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chronic effects to birds and mammals.
c. Risk to Aquatic Animals
To assess potential risk to aquatic animals, the Agency uses a computer model to generate
EECs ofrneiharnidophos In surface water. However, unlike the drinking water assessment described in
the human health risk assessment section of this document, the ecological water resource assessment
does not include the index reservoir and percent crop area factor. These refinements are solely used to
assess pesticide exposure to humans from drinking water sources. Hence, the EECs used to assess
exposure to aquatic animals are not the same as the EEC values used to assess human dietary exposure
from drinking water sources.
Acute risk to freshwater fish and estuarine fish is not of concern for any use patterns, with RQs
ranging from <0.05 to 0,07, The acute high risk, restricted use risk and endangered species risk is of
concern far freshwater invertebrates at fee maximum application rate of 1.0 lb ml A with RQs ranging
from 1.1 to 3.0. Risk may be of concern for some estuarine invertebrates based on suprplementai data
on blue shrimp. No chronic risk assessment was conducted since there are no chronic data for aquatic
species.
d. Incidents"
Approximately six wildlife mortality incidents likely not to be associated with misuse have been
reported to the Agency since 1980. Four of these incidents involved crops which are no longer
registered. Three of these incidents involved adverse impacts on bee colonies including two from use
on potatoes.
e. Endangered Spsdes
Endangered species LOCs are exceeded for acute and chronic risks to birds and mammals and
acute risks to freshwater invertebrates for all currently registered uses of methamidophos.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(1) of the Endangered Species Act. The objective
of this review is to clarify and develop consistent processes for endangered species risk assessments
and consultations. Subsequent to the completion of this process, the Agency will reassess the potential
effects of methamidophos use to federally listed threatened and endangered species. At thai time the
Agency will also consider any regulatory changes recommended in the IRED feat are being
implemented. Until such time as this analysis is completed, the overall environmental effects mitigation
strategy articulated in this document and any County Specific Pamphlets described in section IV of fee
IRED which address methamidophos. will serve as interim protection measures to reduce fee likelihood
that endangered and threatened species may be exposed to methamidophos at levels of concern.
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C Benefits
The Agency 1ms assessed the benefits of all registered uses of methamidophos. A summary of
the Agency's benefits findings is presented below; for mare information, see the following documents:
Use and Usage Analysis for Methamidophos, dated November 20, 2001, and Methamidophos Use
on Cotton, Tomatoes and Potatoes, dated December 6,2001. All of these documents are available
in the public docket and on the internet.
Alfalfa for Seed
In 2000, more than 50% of the alfalfa seed acreage in California was treated with
methamidophos. Hie primary target pest of methamidophos applications is lygus bug, which is a key
pest in alfalfa seed. Lygus bug can cause significant economic damage to alfalfa grown for seed
throughout the growing season. Methamidophos is an important element of a resistance management
program for this pest early in the season, before introducing pollinators into the fields. It is the most
effective chemical for lygus bug control at this time of the season. The alternatives to methamidophos
include methidathion, which is less effective; and synthetic pyrethroids, which have limited use due to
problems with resistance. Methamidophos is applied once per season at an average rate of one pound
per acre.
Cotton
In 2000, an estimated 2% of the U.S. cotton acreage was treated with methamidophos.
Arkansas and Louisiana reported 4% of state cotton acreage treated in that year, while California
reported 2%. The average number of applications made to cotton per year is one at an average
application rate of 0.3 pounds of active ingredient per acre. In California, methamidophos use is
targeted primarily for the control of lygus bugs. State cotton specialists have indicated that
methamidophos is an important part of their IPM programs in California and also noted that lygus bugs
are developing resistance to some alternatives to methamidophos. The alternatives to methamidophos
for lygus bug control include acephate, aidicarb, bifenthrin, cyfluthrin, cypermethrin, dimethoate,
oxamyl, and zetamethrin.
In Louisiana and Arkansas methamidophos applications are targeted primarily for control of
whiteflies and thrips. State experts in Louisiana have indicated that a shifting thrip species population in
to state has increased the importance of methamidophos use there. For thrip control, the alternatives
to methamidophos include acephate, aidicarb, dicrotophos, imidacloprid and phorate. For the control
of whiteflies the alternatives include acephate, buprofezin, chlorpyrifos, fenpropathrin, profenofos, and
pyriproxifen.
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Potatoes
In 2000, an estimated 29% of the U.S. potato acreage was treated with methamidophos.
Washington reported 80% of state acreage treated in that year, while Idaho, Oregon and Pennsylvania
all reported greater than 28% of state acreage treated. The average number of applications made to
potatoes per year ranged from 1 to 32 at an average application rate of between 0.6 and 1.0 pound of
active ingredient per acre. Methamidophos application in potatoes is generally a 7 -10 day
preventative program and cannot be applied within 14 days of harvest.
The three primaiy target pests for use of methamidophos on potatoes are green peach aphid,
Colorado potato beetle and leafeoppers. Pre- and post-emeigenee control of the green peach aphid, a
vector for fee potato leafioll virus, is the critical methamidophos use in most areas of the country.
Alternatives for pre-emergence control include aldicarb, imidacloprid and phorate. Only imidacloprid is
a potential alternative for post-emergence control but it is significantly more costly and does not have •
the period of residua! effectiveness thai methamidophos has that is necessary in some potato growing
regions. There is also concern for potential resistance in some regions fir imidacloprid. Aldicaib's use
for pre-emeigence control is limited due to a 150 day pre-harvest interval (PHI). These circumstances
make methamidophos critical to potato production, especially in the production of potatoes for seed,
where there is zero tolerance for aphids or the viruses they cany.
For Colorado potato beetle control, alternatives to methamidophos include caiboferan,
esfenvaierate, endosulfan. imidacloprid and phosmet The effectiveness of the alternatives vary by
region. In the major production areas, carbo&ian and methamidophos are the most efficacious
pesticides for controlling this pest. For the control of leafeoppers in potatoes, there are a number of
registered alternatives to methamidophos, however, only carbaiyl may provide acceptable efficacy.
Tomato (Fresh)
In 2000, an estimated 15% of the U.S. fresh market tomato acreage was treated with
methamidophos. This is down from an estimated 60% of the U.S. fresh, tomato crop treated with
methamidophos in 1994. In Florida, which accounts for more than 40% of U.S. fresh market tomato
production, 14% of the fresh tomato acreage was treated with methamidophos in 2000. In California,
which accounts for 30% of U.S. fresh market tomato {abduction, 8% of the fresh tomato acreage was
treated with mefiiamidophos in 2000. In Georgia, North Carolina, South Carolina and Tennessee,'
which account for a combined 10% of U.S. fresh market tomato production, 86%, 58%, 46% and
22% of fee tomato acreage in each state was treated with methamidophos in 2000, respectively. Hie
average number of applications made with methamidophos to fresh maricet tomatoes per year ranged
from 12 to 3.3, with average application rates ranging from 0.5 and 1.0 pound of active ingredient per
acre.
Mefiiamidophos is used primarily to control Western flower thrips in fresh tomatoes in the
31
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Southeastern U.S. This pest a primary vector of Tomato Spotted Wilt Virus, which can reduce the
marketable yields on fresh tomatoes by up to 50%. Methamidophos applications are critical for the
control of this pest because growers target as many as 5-6 insecticide applications per season for this
pest, and the only effective alternative to methamidophos, spinosad. is limited to two applications per
season. Without methamidophos, growers would not achieve sufficient control of the pest, and would
likely face significant yield loses from the virus.
Methamidophos is also used to control silverleaf whitefly in the Southeastern U.S. This is a
difficult pest to manage and it transmits Tomato Mettle Virus and Tomato Yellow Leaf Curl Virus,
which can cause significant tomato damage. Methamidophos is considered to be important as a cost-
effective synergist mixed with a synthetic pyrethroid insecticide to control this pest. Hie alternatives to
methamidophos to control silverleaf whitefly include endosulfan, esfenvalerate, fenpropathrin,
imidacloprid, permethrin, pymetrozine, pyriproxifen and thiamethoxam.
In California, the primary target pest for methamidophos on fresh tomatoes is stink bug.
Methamidophos is the only effective insecticide available for controlling this economically important
pest. The primary alternatives to methamidophos for the control of this pest are limited in their
effectiveness. Imidacloprid is oily effective against low populations, dimethoate is a severe hazard to
bees, and endosulfan has waterway restrictions which limit its use. Without methamidophos, growers
would not achieve sufficient control of the pest, and would likely face significant yield losses.
Methamidophos is applied to fresh tomatoes late in the growing season in California.
Therefore, many cultural activities such as weeding, pruning, staking and tying are completed well in
advance of application of this material. By contrast, in the Southeastern U.S., methamidophos is
applied throughout the season, resulting in applications before or soon after these activities occur in the
field. Current labels require a 7 day PHI,
Tomato (Processed')
California accounts for more than 95% of the U.S. production of processed tomatoes. In
2000, an estimated 3% of the California processed tomato acreage was treated with methamidophos.
Methamidophos usage on processed tomatoes has seen a steady decline since the mid-1990's. An
average of one application is made with methamidophos to California processed tomatoes per year,
and slightly less than one pound of active ingredient is applied on average per acre per application.
As in the case of fresh tomatoes in California, the primary target pest of methamidophos
application to processing tomatoes is stink bug. The limitations mentioned earlier on lite primary
alternatives to methamidophos for control of this pest, make methamidophos an important tool in
processed tomato production.
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Meihamidophos is applied to processed tomatoes late in the growing season in CA. Therefore,
many cultural activities such as weeding, pruning, .staking and lying are completed well in advance of
application of this material. Current labels require a 14 day PHI in CA.
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IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(gX2)(A) ofFIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
active ingredient specific) data required to support reregistration of products containing methamidophos
active ingredient.
Hie Agency has completed its assessment of the occupational and ecological risks associated
with the use of pesticides containing the active ingredient methamidophos, as well as a
methamidophos-specific dietary risk assessment that has not considered the cumulative effects of
organophosphates as a class. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient methamidophos, EPA has sufficient information on the human
health and ecological effects of methamidophos to make an interim decision as part of the tolerance
reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The
Agency has determined that methamidophos products are eligible for reregistration provided that: (i)
current data gaps and additional data needs are addressed; (ii) Hie risk mitigation measures outlined in
this document are adopted including the phase out of the cotton use, and label amendments are made to
reflect these measures; and (iii) cumulative risks considered for the organophosphates support a final
reregistration eligibility decision.
As part of the Agency's ongoing process to review and take the necessary risk reduction
measures as required by FQPA, on December 4,2001, EPA released the preliminary cumulative risk
assessment for organophosphate pesticides for public comment. That assessment is based on
evaluation of the potential exposure of 31 total organophosphate pesticides from eating food, drinking
water, and residential sources. The assessment also takes into account EPA's past regulatory actions
on various pesticides, such as eliminating uses. Continuing the effort to ensure transparency of decision
processes, EPA conducted a technical briefing and presented the assessment to the Scientific Advisory
Panel for peer review and comment. Hie Agency intends to release a revised cumulative risk
assessment during summer 2002.
Although the Agency has not yet considered its final cumulative risk assessment for the
organophosphates, the Agency is issuing this interim assessment now in order to identify risk reduction
measures that are necessary to support the continued use of methamidophos. Based on its current
evaluation of methamidophos alone, the Agency has determined that methamidophos products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA.
Accordingly, should a registrant fail to implement any of 1he risk mitigation measures identified in this
document, the Agency may take regulatoiy action to address the risk concerns from use of
methamidophos.
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. At the time that the cumulative assessment is finalized, the Agency will address any outstanding
risk concerns. For methamidophos, if all changes outlined in this document are incorporated into the
labels, then all currently recognized risks will be adequately managed.. But, because this is an lutei n 11
RED, fee Agency may take further actions, if warranted, to finalize the reregistratiom eligibility decision
tor methamidophos afler assessing the cumulative risk of the organophosphatc class. Such an
incremental approach to the reregistration process is consistent with the Agency's goal of improving fee
transparency of the reregistration and tolerance reassessment processes. By evaluating each
organophosphate in turn and identifying appropriate risk mitigation measures, the Agency is addressing
fee risks from fee organophosphates in as timely a manner as possible.
Because fee Agency has not yet concluded its cumulative risk assessment for the
oiganophosphates, this interim reregistration eligibility decision does not fully satisfy fee reassessment of
fee existing methamidophos food residue tolerances as called for by fee Food Quality Protection Act
(FQPA). When the Agency has concluded its cumulative risk assessment, methamidophos tolerances
will be reassessed in feat light At that time, fee Agency will reassess methamidophos along with fee
other organophosphatc pesticides to complete the FQPA requirements and make a final reregistration
determination. By publishing this interim decision on rereglstratlan eligibility and requesting mitigation
now for fee individual chemical methamidophos, fee Agency is not deferring a* postponing FQPA
requirements; rather, EPA is taking steps to assure feat uses which exceed FIFRA's unreasonable risk
standard do not remain on fee label indefinitely, pending completion of assessment required under fee
¦ FQPA This decision does not preclude fee Agency from making further FQPA determinations and
tolerance-related rulemakings feat may be required on this pesticide or any other in fee future.
If the Agency determines, before finalization of fee RED, feat any of fee determinations
described in this interim RED are no longer appropriate, fee Agency will pursue appropriate action,
including but not limited to, reconsideration of any portion of this interim RED.
Label changes for methamidophos are described in Section IV. Appendix B identifies fee
. generic (fata requirements feat fee Agency reviewed as part of its interim determination of reregistration
eligibility of methamidophos, and lists fee submitted studies feat fee Agency found acceptable. ,
B, Summary of Phase 5 Comments and Response
When making its interim reregistration decision, fee Agency took into account all comments
received during Phase 5 of the QP Public Participation Process. Th ese comments in their entirety are
' available in fee docket The Agency received comments from the technical registrant, Bayer
Corporation. Comments were also received from fee National Potato Council, fee California Tomato
' Research Institute, fee National Agricultural Aviation Association, Florida Fruit and Vegetable
Association, Washington State University, California Tomato Commission and Environmental Focus.
The Agency also received approximately 10 comments from various agri-business companies and
associations, commodity groups, farm bureaus, universities, extension, and state agencies, as well as
35
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private citizens, supporting the use of methamidophos. A brief summary of the comments and the
Agency response is noted here.
Registrant Comments
Comment: Bayer noted differences between dietary assessment conducted by EPA versus the
Bayer assessment. The three main differences noted were (1) processing fetors used,
particularly in tomato residue assessment, (2) percent crop treated data used and (3)
imputation of composite residue data appears to be inappropriate and exaggerates
high-end predictions for residues.
Response: The dietary assessment was conducted with the best available data and in accordance
with Agency policy. The most recent dietaiy assessment reflects some of the concerns
noted by the registrant. These include changes to the % crop treated and the use of
processed tomato data.
Comment: Some assumptions used by the Agency in the assessment appear not to be reflective of
assumptions supported by data the Agency has on hand. The risk assessment uses
transfer coefficients ranging from 2500 to 10000 whereas recent studies have shown
that more realistic values range from 100 to 650 for activities such as scouting and
harvesting.
Response: The ride assessment has been revised to incorporate updated TC's which were
generated as a result of the ARTF data. The range of TC's used is 300 to 1500
depending on the crop involved and the activity being evaluated.
Comment: The assessment also appears to have inadequately considered the personal protective
equipment requirements specified on die product label. The revised assessment failed
to use MOSH exposure reduction factors for the label specified respiratory protection.
The revised assessment also used dermal exposure reduction factors that are not
consistent with exposure reduction factors used by other regulatory agencies or with
exposure reduction factors derived from PHED data.
Response: Where possible, the labeled PPE was accounted for in the various PPE scenarios
evaluated in the risk assessment. There are some PPE, such as chemical-resistant
aprons, that the Agency views as qualitative measures because there are no recognized
protection factors (PF) to assess their effectiveness. The Agency has no protection
factors to assess headgear. Face and neck wipe monitoring data constitutes dermal
head exposure values. All occupational handlers were assessed as wearing footwear
(socks plus shoes or boots), foot exposure is not traditionally monitored, and therefore,
36
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a 100 percent protection factor Is implied. Finally, inhalation exposures were not the
most significant risk factor, (if protection factors were increased, IMe change in
combined MOEs would result).
Comment: The uncertainty attributed to interspecies variability for the selected endpoint is not
supported by available human arid animal data. Therefore Bayer believes that an MOE
of 10 provides an adequate margin of safety for the product and should be used for the
methamidophos occupational exposure and risk assessment
Response. Consistent with the Agency's policy announced on December 14,2001, this
assessment does not consider or rely on any third-party studies which intentionally dose
human subjects with toxicants to identify or quantify their effects. Therefore, the
Agency continues to employ the uncertainty of 100.
WasMagtom State University
Comment Comments that EPA rejected a human exposure study and indicated feat if these results
were used, the 100-fold uncertainty fector applied to the chronic RfD could be
confidently reduced.
Response: Consistent with the Agency's policy announced on December 14,2001, this
assessment does not consider or rely on any third-party studies which intentionally dose
human subjects with toxicants to identify or quantify their effects. Therefore, the
Agency continues to employ the 100-fold uncertainty fector.
Comment: Hie potato processing study, although submitted by the manufacturer, has some serious
methodological flaws as pointed out by the Agency. Consequently, the 10X
concentration factor for potato chips is completely unrealistic. The DEEM analysis for
tomato puree has an ambiguous entry. Hie stated processing fector for tomato puree is
0.7, yet the acute DEEM analysis shows that there are several puree types with factors
of 3.3.
Response: Although some irregularities were noted in the potato processing stucfy, the Agency
concluded that these actions did not likely affect the overall conclusions of tie study.
Unless additional in&nnation is provided, the 10X concentration fector will continue to
be used in the dietoy assessment "With respect to tomatoes, a revised dietary
assessment has been conducted which incorporates monitoring data for processed
tomatoes. Since actual processed commodity data was used, a processing fector was
not applied. Consequently, the concerns about the tomato processing fector is no
longer applicable.
37
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Comment: The post application exposure scenario included hand harvesting of potatoes. This is a
situation that is a remote exception rather than the rule. Further, a question was raised
as to the use of different transfer coefficients for different compounds having the same
post occupational activity.
Response: The current policy on transfer coefficients lists potatoes under Vegetables, "root".
Within the root vegetable category, mechanical potato harvesting exposure was
assigned a value of 0. Hand harvesting was listed as out of scope of the transfer
coefficient table. Therefore, hand harvesting is no longer a scenario for which risk
estimates are developed.
California Tomato Research Institute
Comment: The commentor states that the PDP data are not representative of California's 95%
portion of the US processed crop and that using the PDP data coupled with a
processing factor does not deliver a relevant or accurate processed methamidophos
exposure. Use information and residue data collected by California Department of
Pesticide Regulation was provided.
Response: As discussed earlier, a revised dietary assessment which includes USDA monitoring
date for processed tomatoes and percent crop treated information which separates
processed and fresh tomato has been conducted.
Environmental Focus
Comment Environmental Focus has concerns pertaining to assigning a 15% default value for drift
when applying methamidophos next to surface water. The AgDRIFT model does not
specify a drift default value associated with aerial application.
Response: The 15% value is the result of the adoption of the AgDRIFT model, which when used
with default values for droplet size, pond size and wind speed gives that result Hie
modeling conducted by the Agency is intended to be a conservative screening
assessment. The assumptions made are not considered unreasonable and fell within the
range of allowed use of the chemical.
Comment: Environmental Focus has concerns that the Agency uses a scenario in its assessment
that assumes an aerial applicator will apply next to a drinking water supply when wind
speed is 10 mph.
Response: The models are used as a screening tool and, as such, are intended to simulate
situations that could occur in the field. The modeling is done according to the label, and
38
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in conditions that are not intended to be typical but are realistic.
National Agricultural Aviation Association
Comment: NAAA is concerned that the data the EPA uses to determine the occupational risk
associated with, the aerial application are outdated and overly conservative.
Specifically, PBED does not include date, on worker exposure subsequent to 1992-
whlcti is before the Worker ftotection Standards went into effect at a time when many
techniques and equipment to protect workers became commonplace. NAAA
believes that if more current data that takes into account technological advancements
that enhance worker protection, any exposure assessment would demonstrate an
adequate margin of safety for those involved aerial application inducing new :
technological advances.
Response: The Agency considered this comment during the risk mitigation process, lie Agency
would consider any data that the NAAA would submit.
Comment NAAA has concerns pertaining to assigning a 15% default value for drift when applying
metiiamidoplios next to surface water. The AgDRIFT model does not specify a drift
default value associated with aerial application.
Response: See earlier response to similar question.
C. Regulatory Position
I, FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this oiganophosphate. The assessment is for this individual organophosphate, and does not attempt to
fully reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food
tolerances on the basis of cumulative risk ftom substances sharing a common mechanism of toxicity,
such as the toxicity expressed by the organophosphates through a common biochemical interaction with
the cfaolinestsrase enzyme. Hie Agency will evaluate tie cumulative risk posed by fee entire class of
oiganaphosphates once the methodology is fully developed and the policy concerning cumulative
. assessments is resolved.
EPA has determined that risk from exposure to methamidophos is within its own "risk cup." In
39
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other words, if methamidophos did not share; a common mechanism of toxicity with other chemicals,
EPA would be able to conclude today that the tolerances for methamidophos meet the FQPA safety
standards, provided the risk mitigation measures outlined in this document are implemented and
additional data needs are addressed. In reaching this determination EPA has considered the available
information on the special sensitivity of infants and children, as well as the chronic and acute food
exposure. An aggregate assessment was conducted for exposures through food, residential uses, and
drinking water. Results of this aggregate assessment indicate that the human health risks from these
combined exposures are considered to be within acceptable levels. While the combined risks from all
exposures to methamidophos "fill" the aggregate risk cup, the water exposures are based on screening-
level modeling estimates. The Agency has determined that actual drinking water exposures are likely to
be lower than predicted by these models and has made a regulator,' determination that combined risks
from all exposures to methamidophos "fit" within the individual risk cup. Except for those tolerances
that are to be lowered or revoked, the current methamidophos tolerances remain in effect and
unchanged until a full reassessment of the cumulative ride from all organophosphates is considered later
this year.
b. Tolerance Summary
Tolerances for residues of methamidophos in/on plant commodities [40 CFR §180.315 (a) and
(b)] are currently expressed in terms of residues of methamidophos per se.
The available plant and animal metabolism studies indicate that the residue of concern is the
parent methamidophos. Methamidophos is also a metabolite of acephate. It is recommended that
residues of methamidophos resulting from the metabolism of acephate be included under the tolerance
regulations for methamidophos as a pesticide [40 CFR §180.315(c)]. This change is needed to
achieve compatibility with the MRLs of the Codex Alimentarius Commission, if only in terms of residue
definition. Such a change in the residue definition requires deletion of paragraph (d) (8) of 40 CFR
§180.3 which states that methamidophos residues may not exceed the higher of the two tolerances
established for the use of acephate or methamidophos as a pesticide.
The listing of methamidophos tolerances under 40 CFR §180.315 should be subdivided into
parts (a), (b), and (c). Part (a) should be reserved for permanent tolerances, part (b) for tolerances
with regional registration, and part (c) for tolerances reflecting use of acephate formulations alone (i.e.,
no methamidophos formulations are registered for use on these commodities).
The Agency will commence proceedings to revoke and modify existing tolerances, and correct
commodity definitions. The establishment of a new tolerance or raising tolerances will be deferred,
pending consideration of cumulative risk for the organophosphates. "Reassessed" does not imply that
all of the tolerances have been reassessed as required by FQPA, since these tolerances may only be
reassessed once the cumulative risk assessment of all organophosphate pesticides is considered, as
required by the statute. Rather, this IRED provides reassessed tolerances for methamidophos in/on
40
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various commodities, supported by all the submitted residue data, only for the single organophosphate
chemical methamidophos. EPA will finalize these tolerances afier considering the cumulative risks for
all organophosphate feticides. The Agency's tolerance sumniaiy is provided in Table 14. This Mule
lists several tolerances associated with uses that are no longer registered, as announced in FIFRA
6(f)(1) Notices of Receipt of Requests from the registrant for cancellation and/or use deletion, which
EPA approved. Therefore, the associated tolerances should be revoked.
Table 14. Tolerance Summary for MethamMophos
Commodity
Tolerance Listed
Under 48 CER
' . §180. 315
_ . Tolerance Listed _
Reassessed ', „ __ Comment ¦
under 40 CFR L_ : .
Toleraace WCon-sct Commodity Definition]
I §lS0.I0o j
Toleiancss Listed Under-40 CER §180.315 (a)
Beets, sugar, roots
0.02
Revoke
-
The registrants are not supporting
Beets, sugar, tops
0.50
Revels
_
methamidophos use on sugar beets and
there are ho registered aeephateuses.
Broccoli
1.0
Revoke
The registrants are not supporting
methamidopiosuse on bmccoli and there
are no registered acephafe uses.
Brussels sprouts
1.0
1.0
0.5
This tolerance must be moved to
8180315(c).
Cabbage
1.0
Revoke
The registrants are not supporting
metbamidophos use on cabbage and there
are no registered acephct uses.
Cauliflower
1.0
0.5
0.5
This tolerance must be moved to
§180.315(c).
Cottonseed •
0.1 (N)
0.2
—
[Cotton, undelinled seed]
Cucambeis
1.0
Revoke
-
The registrants are not supporting
metfaamMopfaos use on cucumbers and
there are no registered aeephateuses.
Eggplant
1.0
Revoke
_
The registrants are not supporting
metfaamidophos use on eggpkni and there
are no registered acephaS uses.
Lettuce, rissci
1.0
1.0
I
This tolerance must be moved to
§180.315(c).
Melons
0.5'
Revoke
-
The registrants are sot sapportiag
methamMophos use on melons and there
are no registered acephafc uses.
Peppers
1.0
1.0
1
This tolerance must be moved to
§180.315(c). [Pepper, bell and non-bell]
Potatoes
G.1(N)
0.1
-'1
Tomatoes
1.0
ua
|
, Tolerance To Be Proposed Under 40 CER §180315 (a)
41
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Commodity
Tolerance Listed
Uni«r4# CFR
§180.315
Reassessed
Tolerance
T#fer*oce Lifted L
„ , Comment
Under* CTm \,Correa commodity Definition}
§180.108 [
Cotton, gin
byproducts
„
10
[
Tolerance Listed tinder 41) CFR §180315 (b)
Celery
1
1.0
{This tolerance must be moved to
j§ 180315(c).
Tolerances to be Listed Under 40 CFR
§mMm
Bears (succulent
and dry form)
..
1.0
!
[Beans, dry and succulent)
Brussels sprouts
1.0
' 1.0
0.5
Cauliflower
1.0
1.0
0.5
Delay
1
1.0
1
Cranberries
..
0.1
0.1
Lettuce
1.0
1.0
I
[Lettuce, head]
Mint bay
..
2
1
[Mint, tops (leaves and stem}}
Peppers
1.0
1.0
1
[Peppers, bell awl nan-beR]
Soybeans
-
1
42
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Tolerances listed Under 40 CFR §180.315 (a)
Pending label amendments for some crops, adequate field Mai data are available to reassess the
established tolerances for cottonseed, potatoes, and tomatoes. The available data suggest that the
tolerance levels for cottonseed and tomato should be raised to 0.2 ppm and 2.0 ppm, respectively.
The use of methainidophos on Brussels sprouts, cauliflower, lettuce, and peppers was cancelled in
1997. Because there are registered aeephate uses on these crops, meihamidophos tolerances for these
crops should be moved to 40 CFR §180.315(c).
The following tolerances should be revoked as the registrants are not supporting methamidophos
uses and there are no registered aeephate uses on these commodities: beets, sugar, roots; beets, sugar,
tops; broccoli; cabbage; cucumbers; eggplant; and melons.
Tolerance to be Proposed Under 40 CFR §180315' (a)
A tolerance for residues of methamidophos in/on cotton, gin byproducts must be proposed. The
available data support a tolerance level of 10 ppm.
Tolerance Listed Under 40 CFR §180315 (b)
The use of methamidophos on ccleiy was cancelled in 1997. Because there are registered aeephate
uses on this crop, the methamidophos tolerance for this crop should be moved to 40 CFR
§180.315(c).
Tolerances to be Listed Under 40 CFR §180315(c)
The basic producer of aeephate (Valent U.S.A. Corporation) intends to support use of aeephate on
the following food/feed crops: beans (snap, dry, and lima); Brussels sprouts; cauliflower; celery;
cotton; cranberries; lettuce, head; peanut; pepper, uon-beE; pepper, bell; peppemmt/spearmint;
soybean; and tobacco. Therefore, tolerances for residues of methamidophos in/on these commodities
(except tobacco) resulting from use of aeephate should be established under 40 CFR §180315(c).
The tolerance expression in this section should read: 'Tolerances are established for residues of
methamidophos in or on the Mowing raw agicultural commodities as a result of the application of
aeephate:".
Tolerances for combined residues of aeephate and methamidophos in cottonseed meal and hulls
have been established (40 CFR §180.108). However, based on a cottonseed processing study
submitted to satisfy methamidophos reregistestion requirements, methamidophos residues do not
concentrate in cottonseed processed commodities. Therefore, tolerances for methamidophos residues
in cottonseed processed commodities are not required under 40 CFR §180.315(c),
43
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A tolerance for the combined residues of acephate and methamidophos in soybean meal has been
established (40 CFR §180.108). Data for soybean processed commodities were reviewed in the
Acephate Registration Standard Update (dated 1/29/92). In one study conducted in 1978, soybeans
were treated with three applications of a 75% SC/S formulation at 1 or 2 lb ai/A/application (2x or 4x
the maximum seasonal rate Valent wishes to support). Methamidophos residues were found to
concentrate slightly in soybean meal (average concentration of 12x) and hulls (average concentration of
L9x) but not in crude oil. In a second study conducted in 1987, soybeans were treated with 11
applications of a 75% SC/S formulation at 2 lb ai/A/application (~ 15x the maximum seasonal rate
Valent wishes to support). Methamidophos residues were 0.01-0.02 ppm in/on soybeans, 0.02 ppm in
meal, 0.02 ppm in hulls and <0.01 ppm in refined oil. Basal on the exaggerated application rates used
in the studies and the resulting residues in processed commodities, the Agency concludes that no
tolerances are required for methamidophos residues in soybean processed commodities.
For mint hay, data submitted by the registrant since the tolerance was set support an increase in the
tolerance.
Tolerances Listed Under 40 CFR §180315(a) and (b)
Tolerances have been established for residues of methamidophos in/on various raw agricultural
commodities [40 CFR §180.315(a) and (b)]. In addition, tolerances have been established for
combined residues of acephate and its metabolite methamidophos in/on various plant and animal
commodities [40 CFR §180.108(a) and (b)]. Tolerances established for acephate in/on several
commodities (beans, Brussels sprouts, cauliflower, celeiy, cranberries, lettuce, mint hay, and peppers)
include limits on residues of methamidophos.
Residue Analytical Methods
Adequate methods are available for data collection and tolerance enforcement for plant
commodities. For tolerance enforcement, the Pesticide Analytical Manual (PAM) Vol. II lists a GLC
method (designated as Method 1) with thermionic detection for the determination of methamidophos
(LOD = 0.01 ppm) residues in/on plant commodities. PAM Vol. H also lists a TLC method
(designated as Method A) as a confirmatory method. Adequate radiovalidation data for the
enforcement method using samples from the plant metabolism studies have been submitted and
evaluated.
Because no tolerances are required for animal commodities, no enforcement method for animal
commodities is required.
CODEX Harmonization
The Codex Alimentarius Commission has established several maximum residue limits (MRLs) for
residues of methamidophos in/on various plant and animal commodities. Hie Codex MRLs are
expressed in terms of methamidophos per se. Hie expression of residues for Codex MRLs and U.S.
tolerances is harmonized. A numerical comparison of the Codex MRLs and die correspond ing
44
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reassessed U.S. tolerances is presented in Table 15. Further harmonization of U.S. tolerances and
Codex MRLs are not feasible at this time because of differences in agricultural practices*
Table IS. Codes MRLs and Applicable U.S. Tolerances for Metfaamidopfaos.
Codes .
Reassessed U.S.
Tolgrance, ppns
Recommendation And Comments
Commodity, As Defined
MRL
.. (nag/kg)
Alfalfa fcrage (green)
21
-
No U.S. registrations.
Bnisssls sprouts
1
1.0
Cabbages, Head
0.5 2
-
U.S. registrants not supporting use.
Cattle fat
0.01 (*) 3
-
Cattle meat
0.01 (*)
--
Caulffiower
0,5 2
0.5
Celsy
I
1.0
Cotton seed
0.14
0.2
Cucumber
1
--
U.S. registrants not supporting use.
Goat fet
o.oi (*)
--
Goat meat
0.01 f)
-
Hops, dry
5
-
No U.S. registrations.
Lettuce, Head
1
1.0
Melons, except Watenaekm
0.5
_
U.S. registrants not supporting use.
Milks
0.01 (*>
-
Peadi
I2
-
No U.S. registrations.
Peppers, Chili
2
1.0
Peppers, Sweet
1
1.0
Pome fruits
0.5
-
No U.S. registrations
Potato
0.05 4
0.1
Rape seed
0.1
-
No U.S. registrations
Sheep fat
0.01 (*)
-
Sheep meat
0.01 (»)
-
Soya bean (dry)
0.05'
0.01
Sugar best
0.05
-
U.S. registrants not supporting use.
Sugar beat leaves or tops
1
¦ _
U.S. registrants not supporting use.
Tomato
I2
2
Tree tomato
0.01 (*)1
-
No U.S. registrations.
Watermelon
0.5 '
-
U.S. registrants not supporting nse.
Based on treatment with acephate.
45
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2 The MRL is based on residues from the use of methamidophos, not acephate (1996 JMPR).
3 (*) = At or about the limit of detection.
4 Including residues resulting from the use of acephate.
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 FFRA 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).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, methamidophos may be subjected to additional screening and/or testing
to better characterize effects related to endocrine disruption.
3. Labels
A number of label amendments, in addition to the existing label requirements, are
necessary in order for methamidophos products to be eligible for reregistration. The Agency has
determined that these measures, in addition to the existing label requirements, will adequately reduce
risks to handlers.
Provided the following risk management measures are incorporated in their entirety into labels for
methamidophos-containing products, the Agency finds that all currently registered uses of
methamidophos are eligible for interim reregistration, pending consideration of cumulative risks of the
organophosphates. While all uses are eligible at this time, the cotton use will be phased out over five
years. The regulatory rationale for each of the risk management measures outlined below is discussed
immediately after this list of required ride management measures.
a. Agricultural Use Exposure Reduction Measures
For agricultural use, the following measures are required, in addition to the existing labeling
requirements to address drinking water, occupational handler and ecological risks of concern. The
registrant has not yet agreed to these measures.
* Require all labels be amended to indicate that applications must be made using enclosed cab
tractors or enclosed cockpits.
46
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• Require all labels be amended to indicate that flaggeis most be in enclosed vehicles or mechanical
flaggers be used; or the use of ground positioning system (GPS) equipment that negates the need
for flaggers for aerial 'application,
• Require all labels to reduce maximum # of applications to 2 per season during phase out period
for cotton.
• Require all labels to reduce maximum # of applications to 4 or less per season for tomatoes .
(current SLNs that have maximum # of applications less than 3 would retain that number of
applications).
« Require all labels to increase REIs for all activities to 4 days for potatoes.
Require Section 24(c) labels to increase REIs fir all activities to 4 days for tomatoes except in
CA where the REI will remain at 3 days.
b. Homeowner Use Exposure Reduction Measures
There aw no residential uses for methamidophos.
D. Regulatory Rationale
The Mowing is' a summary of the rationale for managing rides associated wife fee use of
methamidophos. Where labeling revisions are imposed, specific language is set forth in the summary
tables of Section V cf this document.
¦ 1. Human Health Risk Mitigation ¦
a. Dietary Mitigation
Dietary risk from food sources alone are not of concern. Screening level modeling estimates
indicate that aggregate methamidophos exposure from food and drinking water may fill fee risk cup:
however, the Agency has detsmined that drinking water exposures are likely lower than, predicted.
Therefore, the Agency has made an interim determination feat no additional mitigation is necessary at
this time. EPA will require additional data to refine fee drinking water modeling values and confirm this
interim conclusion.
: 1) Acute Dietary (Food)
Acute dietaiy (food) exposure to methamidophos from applications of methamidophos alone,
and from "all sources" (applications of methamidophos and acephate) result in rids estimates feat are
below fee Agency's level of concern—feat is, less than 100% of fee acute PAD is used. For example,
for exposure resulting from applications of methamidophos alone, for the most exposed subpopulaticn,
children 7-12 years old, fee percent acute PAD value is 33% at the 99 Sth percentile of exposure from'
consumption of toed alone.. For exposure resulting from applications of methamidophos alone and
methamidophos residues from fee application of acephate, for fee most exposed subpopulaiion, all
infants, fee percent acute PAD value is 76% at fee 99.9th percentile of exposure from consumption of
food alone. No mitigation measures are necessary at this time to address acute dietaiy risk from food.
47
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2) Chronic Dietary (Food)
Chronic dietaiy (food) exposure estimates are below the Agency's level of concern for all
subpopulations. For the most highly exposed subpopulation, children 1-6 years old, the percent
chronic PAD values are 15% for methamidophos alone and 37% when including methamidophos
residues from the application of acephate, from consumption of food alone. No mitigation measures are
necessary at this time to address chronic dietary risk from food.
3) Drinking Water
Surface water drinking water estimated concentrations were derived from the PRZM-EXAMS
model with the Standard Index Reservoir and percent crop area (PCA) and the GEENEC model (for
methamidophos derived from application of acephate). Ground water estimated concentrations were
derived from the SCI-GROW Model. These are screening level estimates designed to provide high-
raid estimates of potential pesticide exposure. Such predictions provide a screen to eliminate those
chemicals that are not likely to cause concerns in drinking water. Exceedanees in drinking water risk
assessments using the screening model estimates do not necessarily mean a risk of concern actually
exists, but may indicate the need for better data (e.g., monitoring studies specific to use patterns and
drinking water sources) on which to confirm decisions.
Based on model predictions of currently registered uses, the EECs for methamidophos from the
application of methamidophos in surface water range from 28,6 to 61.8 ppb for acute exposure, and
from 1.5 to 3.8 ppb for chronic exposure. The only surface water EEC calculated for methamidophos
from the application of acephate, using the Tier I GEENEC model is 22 ppb. The acute and chronic
EEC for methamidophos from all sources in groundwater is 0.033 ppb. Table 3 summarizes the
modeled EECs for the respective crop scenarios.
The acute and chronic dietary risks from drinking water exposure from ground water sources are
not of concern because the groundwater EECs are well below the DWLOCs. The acute and chronic
dietary risks from drinking water exposure from surface water sources are above the Agency's level of
concern for all subpopulations. However, there are uncertainties which lead the Agency to expat that
actual exposure from drinking water is unlikely to be as high as the levels used in the development of the
risk assessment which are based on screening models. Based on these uncertainties and the anticipated
reduction in water contamination implementing the risk reduction measures contained in this document,
the Agency believes that the risks from drinking water are not of concern.
The drinking water risk assessments are based on screening level models that are conservative in
their estimates of drinking water exposure. Actual exposure is expected to be lower than the EEC's
reported in the IRED. An example of the type of assumptions used in the model that can contribute to
conservative estimates involves rainfall levels. To determine what rainfall level to use in the model, the
Agency identifies a peak rainfall level for each of 36 years of daily rainfall data. The model then
assumes that rainfall will equal the 90th percentile of these 36 annual peak values when estimating
concentrations, a conservative assumption. Also, the percent cropped area (PCA) assumption for
potatoes used in the model is 0.87, the default assumption. This means the model assumes that 87% of
a watershed is planted with one of these crops and that 100% of this crop is treated with
48
-------
¦ methamidophos, which appears unlikely to occur especially considering that the PCA calculated for
major crops like com and cotton using data submitted to the Agency are 0.46 and 0.20 respectively.
For example, with, respect to the scenario with the highest calculated EEC, potatoes in Maine, it is
estimated that 65,000 acres of potatoes are grown in the state of Maine each year. If It was assumed
that all that acreage fell into any one of the nine watersheds in Maine as a worst-case scenario, the
range of PCA values would likely be 0.04 to 0.16 or 4% to 16%, significantly lower than the 87%
assumption. The effect of the PCA value on EECs has a linear relationship. Consequently, using these
values would reduce EECs by a factor of 5 to 20. Even though this analysis has not been deemed to be
sufficient to change the PCA quantitatively, it does provide a sense of the potential uncertainty of the
modeled water concentrations in this case.
With regard to the potential risks associated with acephate application, the model used to
estimate water concentrations is a tier I model and, as such, is not as refined as the tier 1FRZM-
EXAMS model A higher-tiered model was not used is this case due to the high level of uncertainty
surrounding any estimate of the decay rate for acephate and the transformation rate of acephate to
methamidophos which are needed to use the FRZM-EXAMS model This increases fee level of
uncertairity associated with these estimates. For the purposes of assessing drinking water risks from
exposure to methamidophos from all sources (Le. including both methamidophos and acephate
applications) fee Agency will rely upon the model estimates generated using fee PRZM-EXAMS model
with fee Index Reservoir (IR) and Percent Crop Area (PCA) modifications described above which are
based upon the application of methamidophos alone. The Agency believes that the conservative default
PCA used for the scenario with fee highest EEC (potatoes in ME) discussed above would most likely
account for methamidophos residues from both methamidophos and acephate applications in a given
watershed. As mentioned above, these estimates may be as much as a factor of 5 to 20 times greater
than actual water concentrations. Further, fee main crop uses of acephate (beans, cotton, lettuce and
tobacco) are either not grown in Maine or are not likely to have significant acreage. Therefore,
additional contribution of methamidophos residue from the application of acephate in this scenario is ¦
very unlikely. These considerations support fee belief that this modeled .EEC likely provides a
sufficiently protective estimate of exposure to methamidophos from all sources in drinking water.
Further, the information is not currently available to enable the Agency to use a Tier II model to
estimate 'Concentrations of methamidophos from fee application of acephate, as described above, and it
is not considered appropriate to combine fee results of a Her II assessment (methamidophos
¦ applications) wife fee results of a Her I assessment (acephate applications).
Hie risk reduction measures contained in this IRED, including a phase out of fee cotton use and
fee reduction in fee maximum number of applications allowed per season for all crops, are expected to
reduce fee amount of methamidophos available to reach surface waters. This supports fee Agency's
belief feat drinking water risks will be reduced to a level at which the risk cup is not exceeded.
Furthermore, for many chemicals where there are uncertainties in fee modeling estimates, fee
Agency also relies on actual monitoring data, to confirm resultant expectations. Thus, for
methamidophos. fee Agency is also requiring confirmatoiy surface water monitoring data to evaluate
actus! acute and chronic concentrations of methamidophos in the drinking water sources. This -
monitoring data is to be generated from a multi-year sampling program involving community water
systems from surface water sources in multiple locations in different regions of fee county to represent
different use sites, crops, soil types, and rainfall regimes. Water samples are to be analyzed to
49
-------
determine the concentrations of methamidophos. Also, prior to initiating this sampling program, the
registrant is required to submit a study protocol to the Agency to ensure that the sampling locations and
procedures are adequate to address the drinking water risk concerns.
b. Homeowner Risk Mitigation
Methamidophos is not registered for use in residential settings. Previously, aeephate had
numerous residential, recreational and institutional uses which were evaluated in the aeephate IRED.
To mitigate risks of concern, aeephate use in these settings have been limited to indoor use in non-
residential institutional settings such as schools and hospitals, use on ornamentals in the residential
settings, spot or mound treatments for fire ant and harvester ant control, and use on golf course turf.
The risks associated with the degradation of aeephate to methamidophos for these uses were evaluated
in the aeephate IRED and were found to be negligible. Therefore, no further risk mitigation is needed
with respect to the residential uses of aeephate to address risks associated with methamidophos
exposure.
c. Aggregate Risk Mitigation
The Agency's aggregate risk assessment for methamidophos is based on exposure estimates for
food and residential uses, and uses a screening-level assessment of modeled estimates for drinking
water contamination. Dietary (food) risk estimates are based on a refined assessment that incorporates
percent crop treated data, monitoring data, and processing data.
Acute Exposure
The acute aggregate risk assessment for methamidophos from all sources combines exposure
from food and drinking water sources only. Acute dietary (food) exposure estimates are below 100%
of the aPAD for the US population and all population subgroups. Infants are the most highly exposed
population subgroup and result in an acute drinking water level of comparison (DWLOC) of 2 •9 ppb.
Based on screening-level model predictions of the remaining supported uses, the acute (peak) drinking
water estimated concentration in surface water is 61.8 ppb which is of risk concern to the Agency. The
screening-level model predictions of acute concentrations in ground water is 0.033 ppb for
methamidophos, which is less than the DWLOC and not of risk concern to the Agency.
However, due to the uncertainties and limitations of the model predictions, the Agency believes
that actual acute concentration of methamidophos in surface water is likely to be less than the
DWLOC. To demonstrate this, confirmatory surface water monitoring data is to be generated to
address this risk concern.
Short-Term Exposure
As mentioned above, methamidophos is not registered for use in residential settings. Previously,
aeephate had numerous residential, recreational and institutional uses which were evaluated in the
aeephate IRED. To mitigate risks of concern, aeephate use in these settings have been limited to
indoor use in institutional settings such as schools and hospitals, use on ornamentals in the residential
settings, spot or mound treatments for fire ant control, and use on golf course turf. The risks
50
-------
associated with the degradation of aeephate to methamidophos for these uses were evaluated In. the
aeephate EKED and were found to be negligible. Therefore, no fcitfaer risk mitigation is needed wife
respect to the residential uses of aeephate to address risks associated with methamidophos exposure.
Chronic Exposure
Similarly, the chrome aggregate risk assessment for methamidophos combines exposure from
food and drinking water sources only. Chronic dietaiy (food) risk estimates are Well below 100% of
the cPAD for tie US population and all population subgroups. Children 1-6 yeais old is the most highly
exposed population subgroup and result in a chronic DWLOC of 0.9 ppb. Based on screening-level
model predictions of the remaining supported uses, the average (chronic) estimated concentration in
surface water is 3.8 ppb, which is of ride concern to the Agency. Similarly, due to the same
uncertainties and Imitations of the model predictions fee acute exposure, fee Agency also believes that
actual chronic concentrations of methamidophos in surface is likely to be less than fee DWLOC. To
demonstrate this confirmatoiy surface water monitoring data is to be generated to address the risk
concern.
Hie screening-level model predictions of acute concentrations in ground water is 0.033 ppb for
methamidophos, which is less than the DWLOC and not of risk concern to the Agency.
d. Occupational Risk Mitigation
. 1) Agricultural Uses
As described in PR Notice 2000-9, Worker Risk Mitigation for Organophosphate Pesticides,
it is the Agency's policy to mitigate occupational risks to the greatest extent necessaiy and feasible with
pereonal protective equipment and engineering controls. In managing risk, EPA must take into account
the economic, social, and environmental costs and benefits of the pesticide's use. A wide range of
feelers are considered in making risk management decisions for worker risks. These factors include, in
addition to the calculated MOEs, incident data, the nature and severity of adverse effects, uncertainties
in the risk assessment the cost, availability and relative risk'of alternatives, importance of fee chemical
in integrated pest management (B?M) programs, and other similar factors. •
Handlers
As summarized in Table 7, occupational risks are of concern (i.e„ MOEs < 100) for all
scenarios, even when maximum PPE (i.e, double layer clothing, gloves, and a respirator) are utilized.
Handler risks are also of concern for many scenarios wife engineering controls (closed mixing/loading,
enclosed cabs). Engineering controls are considered to be the maximum feasible mitigation. For
walkers wearing the maximum PPE described above, MOEs range from 2.5 to 38 for mixer/loaders
and from 3.9 to 59 for applicators and flaggers. For workers using fee engineering controls described '
above, MOEs range from 5 to 74 for mixer/loaders and from 8.4 to 626 for applicatorsfflaggers.
Current labels 'require closed mixing/loading systems to be used. To mitigate occupational risks
associated wife fee use of methamidophos, fee following measures are to.be implemented for fee alfelfe,
cotton, tomato and potato uses to be eligible for registration.
51
-------
Applicators must be in an enclosed cab or cockpit.
• Flaggers must be in enclosed vehicles or mechanical flaggers; or the use of global positioning
system (GPS) equipment that negates the need for flaggers for aerial application must be used.
The cotton use must be cancelled.
Even with maximum engineering controls (closed mixing/loading system and enclosed cabs) the
MOEs for all mixer/loader scenarios, die groundboom applicator for cotton scenario and all aerial
application scenarios remain less than the Agency's target of 100. For cotton scenarios, the Agency
has determined that the benefits of this use do not offset the risks. However, the benefits discussed
above are significant enough that a 5-year phase out rather than immediate cancellation of this use is
justified to allow ample time for transition to alternatives.
For the alfalfa seed use of methamidophos, the Agency has determined that significant benefits
exist to support reregistration for this use. Methamidophos is critical for the control of lygus bug in
California alfalfa seed fields. It is an important element of California's lygus tag resistance management
program, and is the most effective control of lygus pest early in the season, prior to introducing
pollinators into the fields.
For the potato uses, the Agency has determined that significant benefits exist to support
reregistration for this use. As mentioned earlier, post-emergence control of the green peach aphid, a
vector for the potato leafroll virus, is the critical use in most areas of the country. Only imidaeloprid is a
potential alternative for post-emergence control but it is significantly more costly and does not have the
period of residual effectiveness that methamidophos has that is necessary in some potato growing
regions. There is also concern for potential resistance in some regions for imidaeloprid. These
circumstances make methamidophos critical to potato production, especially in the production of
potatoes for seed where there is zero tolerance for aphids or the viruses they cany.
For the tomato uses of methamidophos, the Agency has determined that significant benefits exist
to support reregistration for this use. In the Southeastern U.S., methamidophos is one of only two
chemicals available for the control of the Western flower thrip, which is a vector for Tomato Spotted
Wilt Virus, which can cause significant economic damage to a tomato crop. For fresh and processed
tomatoes in California, methamidophos is the only effective insecticide available for controlling the
economically important stink bug. The limitations mentioned earlier on endosulfan, dimethoate and
imidaeloprid make methamidophos an important tool in fresh and processed tomato production in
California.
In addition to the benefits outlined above, there is some uncertainty associated with the Agency's
risk estimates for methamidophos. This uncertainty is explained in the following section on post
application risk.
Post-Application Risk
EPA develops exposure assessments on post-application workers for various crops and
activities at intervals following the application until risk falls below a target level. For methamidophos.
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the target level for risk concerns is an MOE of 100.
In order to determine the EE! for a crop, EPA calculates the number of days that must elapse
after pesticide application until residues dissipate and risk to a worker fells below the target MOE.
Occupational risks are regulated under the FIFRA section 3(c)(5) standard - "without unreasonable
adverse effects on the environment" - which means that both risks and benefits must be considered in
making a risk management decision. This standard may be met at a level below tie target MOE when
there are significant benefits associated with a specific activity. As the worker exposure database has
improved, risk assessments are now conducted for a variety of post-application activities based on fee
level of exposure for each worker activity. For a specific crop/pesticide combination, fee duration
required to achieve the target MOE can vaiy depending on the activity assessed.
In general, EPA prefers to set a single REI for all activities related to a crop or crop' group
without additional activity-based labeling. This approach is favored because handlers and workers are
more likely to understand and comply with simpler labels. Also, permitting entry for some activities
during the REI could cause confusion and compromise the -effectiveness of the Waiter Protection
Standard (WPS). However, when fee consideration of risks and benefits indicate that a single REI is
unworkable, EPA may consider either setting an REI with early entry exceptions for one or more
critical tads or establishing an entry prohibition for a specific task after the REI has expired. For
methamidophos, no critical activities have been identified to warrant the use of an activity-based
exception or prohibition.
In weighing worker risks and benefits, the Agency considered the timing of field activities feat are
critical to crop production. For many of the methamidophos uses discussed below, scouting and
irrigation are critical activities in crop production, and these activities routinely need to be performed
soon after application. In evaluating fee restricted entry intervals, the Agency considered the exceptions
to the WPS that could inform fee decision. EPA's proposed REIs take into account the flexibility
already provided by these exceptions. Scouting is a handler activity under the WPS, so anyone
perfoimBig this activity may legally enter fee treated field during the REI provided they use fee handler
personal protective equipment (PPE) specified on fee label. In addition, if fee scout is a certified crop
advisor as defined in fee WPS (40 CFR 170.204(b)), the individual can determine fee appropriate PPE
to be used. For many of these crops, irrigation equipment is not routinely moved by hand. For these
methods, the primary activity involves entering fee field to turn the watering equipment on and off. This
activity is allowed during the REI under the no contact exception to WPS (40 CFR 170.112(b)).
Should irrigation equipment need unexpected repairs during fee REI, WPS allows workers to enter a
treated field provided early entry PPE is used (40 CFR 170.112(c)).
To mitigate post-application occupational risks associated with the use of methamidophos, the
following measures are tote implemented for the tomato and potato uses to be eligible for
^registration.
* Increase REIs for all activities for tomatoes to 4 days in all states except California where
the REI would remain at 3 days per the cuirent labels.
* Increase REIs for all activities for potatoes to 4 days.
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For tomatoes in California, hand harvesting re-entry risks are adequately addressed by the 7-day
and 14-day PHIs currently on labels. Methamidophos is applied late season to tomatoes in California
therefore pruning, staking, tying and activities associated with immature plants are not a re-entry issue
there. An REI of 3 days would result in an MOE of 70 for irrigation and scouting of mature plants
which are fee key activities of concern.
For tomatoes in Florida, an REI of 4 days would result in an MOE of 31 for irrigation and
scouting of mature plants and an MOE of 22 for hand harvesting tying, pruning and staking which are
the key activities of concern. Re-entry risks for hand harvesters are not adequately addressed by the
7-day PHI currently on labels (MOE = 30).
For tomatoes in other areas of the country, an REI of 4 days would result in an MOE of 45 for
irrigation and scout ing of mature plants and an MOE of 32 for hand harvesting, tying, pruning and
staking which are the key activities of concern. Re-entry risks for hand harvesters are not adequately
addressed by the 7-day PHI currently on labels (MOE = 66).
For potatoes, an REI of 4 days would result in an MOE of 44 for irrigation and scouting of
mature plants which are the key activities of concern.
While the MOEs that result from these mitigation steps do not folly address the risks of concern
(i.e. MOEs are not greater than 100), the following information was taken into consideration in making
these risk management decisions. These considerations are in addition to the benefits that have been
discussed previously in this document.
In the case of tomatoes, as mentioned earlier, the Agency evaluated reentry risk based on data
available from GA, FL and GA. More specifically, the data from FL was developed in the southern
part of the state while die GA data was collected in the southern part of that state. The test area in GA
is significantly closer to the areas in FL where methamidophos use is critical, which are predominantly in
the northern areas of the state, than the test fields where the data were developed in southern FL.
Therefore, it is likely that the GA data and the associated REIs would be more appropriate when
considering the re-entry risks in the major methamidophos use areas in FL resulting in significantly
increased MOEs for the FL scenario.
Further, there is some uncertainty associated with the Agency's worker risk estimates from the
endpoint selected for methamidophos. MOEs are calculated by dividing the hazard endpoint by die
estimated exposure. At present time, the Agency selects endpoints based on NOAELs and LOAELs
from available toxicology studies. By definition, NOAELs and LOAELs are actual dose levels tested in
these studies. The value of die NOAEL or LOAEL is determined solely by the dose selection in the
toxicity study. NOAELs and LOAELs may be numerically close (e.g., 5 mg/kg/day vs. 6.5 mg/kg/day);
or they may also be orders of magnitude apart (e.g., 5 mg/kg/day vs. 500 mg/kg/day). The use of
NOAELs and LOAELs as toxicofogical endpoints is an established and scientifically accepted method
of performing risk assessments and will continue to be used in risk assessments performed by the
Agency. However, the Agency is considering the use of benchmark; dose modeling techniques for
determining toxicologic^ endpoints for use in risk assessment Benchmark dose modeling involves the
use of statistical and mathematical curve fitting procedures to refine the endpoints used in risk
assessment
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In the case of methamidophos, a short-tenn derma! endpoint of 0.75 mg/kg/day was selected for
use in occupational exposure assessments. As mentioned earier, tills endpoint is based on the
NOAEL from a 21-day dermal toxicity study. Hie LOAEL fern this study is 112 mg/kg/day based
on brain, plasma and RBC cholinesterase' inhibition. For this dermal toxicity study, the value of the
NOAEL is approximately 15-fold smaller than the LOAEL.
Methamidophos was selected as the index chemical in fee Preliminary Cumulative Risk .
Assessment (PCRA) for the OPs. This selection was based on the availability of high quality dose-
response data for brain, plasma, and RBC cholinesterase inhibition and also fee availability' of date, for
all of the exposure routes of interest (oral, dermal, and inhalation). Due to the complexity of issues
suBOundmg the estimation of cumulative risk of a large group of chemicals, it was determined that ¦
benchmark dose modeling was preferred over using NOAELs/LOAELs for determining endpoints for
use in cumulative risk extrapolations. In the PCRA the BMDi0, or the estimated dose to cause a 10%
reduction brain cholinesterase activity, was selected as an appropriate endpoint. Because
methamidophos is being used as the index chemical fa the cumulative risk assessment of OPs, BMDtos
and also the respective BMDLs (the lower 95% confidence limit on fee BMD10) have been calculated
from the methamidophos 21-day dermal toxicity study mentioned above for male and female rat brain
cholinesterase. These BMD10s and BMDLs for male and female rat brain cholinesterase activity are
shown in the table below.
Table 16. BMDlGs and BMDLs from the methamidophos 21-day dermal study for brain
cholauesterase acfMty measured in
female and male rats
Route of
Administration "
Sex
BMDm
(mg/kg/day)"
' BMDL
(mg/kg/day)
NOAEL .
' (mg/fegMay)
Denrtal
F
2.12
1.77
0.75
M '
1.88
1.41
It is notable that the BMDLs arc very close to the BMD10s indicating very narrow confidence
limits. Although the BMD10 s and BMDLs have not been calculated for plasma and RBC ' '
cholinesterase inhibition, based on the results of other toxicity studies in methamidophos, the Agency
does not expect the benchmark dose calculations for the BMD10s or the BMDLs fiom the blood
compartments to be significantly different from the results shown in Table 16.
The Agency's drafi guidance on use of benchmark dose specifies that the BMDL, and not the
BMDjq, should be used as the endpoint for risk extrapolation. As die Agency expands its use of
benchmark dose modeling techniques in its single chemical risk assessments, the BMDLs, not BMD10s,
are likely to be used.
The BMDL for male brain cholinesterase inhibition (1.44 mg/kg/day) is approximately 1.9 times
. larger than fee NOAEL of 0.75 mg/kg/day being used to estimate short-term dermal occupational risk.
In order to better characterize the potential risks to persons entering treated fields and being exposed to
methamidophos residues, the Agency looked at the effect of using the BMDL 'instead of fee NOAEL as
is customay in deriving MOEs. For example, using fee NOAEL of 0.75, the resulting MOE for sfaort-
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term post application risk for potatoes at day 4 alter treatment is 44. If the more refined endpoint (i.e.,
the BMDL of 1,44 mg/kg/day) were used instead the resulting MOE would be approximately 84.
Based on this comparison, the Agency believes that the short-term dermal occupational ride would not
exceed 44 but may be as high as 84.
In summary, when deciding whether the benefits of use provided by methamidophos outweigh
the risk the Agency takes into consideration all available information. This includes the effects of the
use of the BMDL versus the NOAEL on MOEs, dislodgeable foliar residue date specific to those
regions of the country where methamidophos is most likely to be used, and the need for growers to
enter treated fields at a particular time to perform spec ific activities and the consequences of not being
able to complete those activities. Therefore, the Agency believes that the REIs set forth as mitigation in
this IRED are appropriate.
2. Environmental Risk Mitigation
The Agency has ecological risk concerns regarding the acute risks of methamidophos to
terrestrial birds and mammals, and to freshwater and estuarine invertebrates; and chronic risk concerns
to birds and mammals and freshwater and estuarine invertebrates. The ecological risk assessments
exhibit RQ values which exceed the various target levels of concern (LOCs).
Birds and Mammals
The Agency's assessment suggests the potential for the liquid formulation to cause acute effects
to birds for broadcast applications. The avian acute RQs range from 0.38 to 6.63. The highest avian
acute RQ is from nine 1 lb ai/A ground or aerial applications to tomatoes. For the same use patterns,
mammalian acute RQs range from 0.2 to 203. Regarding chronic risk to birds, the RQs range from
2.49 to 32.87. Again the same use patterns resulted in chronic RQs for mammals ranging from 0.75 to
9.86. All use patterns are of concern to the Agency for acute and chronic effects to birds and
mammals.
Because of the toxicity of methamidophos, to help protect terrestrial birds and mammals, it is
very important to reduce their potential exposure to methamidophos products that have been applied.
In additional to the phase out of the cotton use previously described in this document to mitigate
occupational risks of concern which will also serve to reduce risk to birds and mammals, several
additional mitigation measures are needed to reduce risks to birds and mammals. These are:
• Require all labels to reduce maximum # of applications to 2 per season during phase out period
for cotton.
• Require all labels to reduce maximum # of applications to 4 per season for tomatoes.
It should also be noted that significant benefits exist for both the tomato and potato uses as
described earlier.
Aquatic Organisms
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Acute ride to freshwater fish and estaame fish is not of concern for any use patterns, with RQs
ranging fiom <0.05 to 0.07. The acute high risk restricted use risk and endangered species risk is of
concern for freshwater invertebrates at the maximum application rate of 1.0 lb ai/A wife RQs ranging
fiom 1.1 to 3.0. No chronic risk assessment was conducted since there are no chronic data for aquatic
species.
Many of the measures previously described in this document to reduce occupational and
terrestrial risks will also serve to reduce aquatic risks of concern. It should also be noted that significant
benefits exist far both the tomato and potato 'uses as described earlier.
E. Otter Labeling
In older to remain eligible for reiegistratkai, other use and safety information need to be placed
on the labeling of all end-use products containing methamidophos. For the specific labeling statements,
refer to Section V of this document
1, Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts cm endangered and threatened species, and to implement
mitigation measures that address these impacts. The Endangered Species Act requires federal agencies
to ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses'to affect any particular species,
EPA puis basic toxicity and exposure data developed for REDs into context for individual listed species
and their locations by evaluating important ecological parameters, pesticide use information, the
geographic relationship between specific pesticide uses and species locations, and biological
requirements and behavioral aspects of the particular species. This analysis will lake into consideration
any regulatory changes recommended in this RED that .are being implemented at this time. A
determinati on that there is a likelihood of potential impact to a listed species may result in limitations on
use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3,1989) is currently being implemented cm an interim basis. As part of tie interim
program, the Agency has developed County Specific Pamphlets that articulate many of the specific
measures outlined in the Biological Opinions issued to date. Hie Pamphlets are available fir voluntary
use by pesticide applicators on EPA's website at www.eoa.gov/espp. A final Endangered Species
Protection Program, which may be altered from the interim program, will soon be proposed for public
comment in the Federal Register.
2. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, State
Lead Agencies for pesticide regulation, and other parties to develop the best spray drift management
practices. Hie Agency has completed its evaluation of the new database submitted by the Spray Drill
Task Force and is developing policy on how to appropriately apply the data and the AgDMFT
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computer model to its risk assessments for pesticides applied by air, orchard airblast, or ground
hydraulic spray. After the policy is in place, the Agency may impose further refinements in spray drift
management practices to reduce off-target drift and risks associated with aerial application or other
application methods associated with drift, where appropriate.
Based on these analyses, the Agency is in the process of developing more appropriate label
statements for spray, and dust drift control to ensure that public health, and the environment are
protected from unreasonable adverse effects. In August 2001, EPA published draft guidance for label
statements in a pesticide registration (PR) notice ("Draft PR Notice 200l-X" http://www.epa.gov/
PR_Notices/#2001). A Federal Register notice was published on August 22,2001
(http ://www.epagov/fedrgstr) announcing the availability of this draft guidance for a 90-day public
comment period. After review of the comments, the Agency will publish final guidance in a PR notice
for registrants to use when labeling their products.
In the interim, registrants may choose to use the proposed statements. Registrants should read
and refer to the draft PR notice to obtain a full understanding of the proposed guidance and its intended
applicability, exemptions for certain products, and the Agency's willingness to consider other versions
of the statements.
Registrants may elect to adopt the appropriate sections of the proposed language below, or a
version that is equally protective, for their end-use product labeling for the purpose of complying with
the deadlines for label submission outlined in this document. The proposed label language is as follows:
For products applied outdoors as liquids:
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas, nontarget
crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals."
"For ground boom applications, apply with nozzle height no more than 4 feet above the ground
or crop canopy, and when wind speed is 10 mph or less at the application site as measured by
an anemometer. Use (registrant to fill in blank with spay quality, e.g. fine or medium) or
coarser spay according to ASAE 572 definition for standard nozzles or VMD for spinning
atomizer nozzles."
"For aerial applications, the boom width must not exceed 75% of 1he wingspan or 90% of the
rotary blade. Use upwind swath displacement, and apply only when wind speed is 3 -10 mph
as measured by an anemometer. Use (registrant to fill in blank with spray quality, e.g. fine
cm- medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for
spinning atomizer nozzles. If application includes a no-spray zone, do not release spray at a
height greater than 10 feet above the ground or the crop canopy."
For overhead chgmigation:
"Apply only when wind speed is 10 mph or less."
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On all re-oduct labels:
"The applicator also must use all other measures necessary to control drift"
"For ground rig applications, apply product no more than 4 feet above the pound
or tie crop canopy, and only when wind speed is 10 mph or less at the application
site as measured by an anemometer."
"For aerial applications, use upwind swath displacement, and apply only when wind speed is 3 -
10 mph as measured by an anemometer. If application includes a no-spray zone, do not release
dust at a height greater than 10 feet above the ground or the crop canopy."
Or
'The applicator also must use all other measures necessary to control drift."
Alternatively, registrants may elect to use the following language, which is the current Agency
policy on drift labeling:
For products that are applied outdoors in liquid sprays (except mosquito aduMcidesl regardless
of application method the following must be added to the labels:
"Do not allow this product to drift."
The Agency recognizes that the above option does not address other application types.
Registrants may therefore wish to adapt some variation of the old, and proposed new language for their
particular products, depending on their application methods.
F. MsthamMopiMss Risk Mitigation Snmmaiy
Based on the rationale for fee interim decisions associated with the use of mefeamidophos, the
following risk mitigation measures are also necessaiy to be incorporated in their entirety into labels for
metiiaimdophos^ontaining products in order for methamidophos to be eligible for reregistraiion.
Registrants may propose, and EPA will consider, alternative mitigation measures feat provide
appropriate mitigation of the identified risks. Specific language of these revisions is set forth in fee
summaiy tables of Section V of this document. Likewise, the data required to be provided to fee
Agency to confirm these regulatory decisions are also listed in Section V.
1. Dietary Misk
No label changes necessaiy, however certain confirmatory data listed in Section V is required.
2. Occupational Risk
The following measures are necessary to mitigate handler risk:
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• Applications must be made using enclosed cab tractors or enclosed cockpit aircraft.
• Mechanical flaggers for aerial application; or the use of global positioning system (GPS)
equipment that negates the need for flaggers.
The following measures are necessary to mitigate risk to post-application workers:
• For foliar application of the liquid fonnulation, a 4 day REI is necessaiy for tomatoes in all states
except CA
• For foliar application of the liquid formulation, a 4 day REI is necessaiy for potatoes.
The following additional measures are necessary to mitigate risks of concern for specific crops:
Cotton: Implement a 5-year phase out of the use on cotton.
3. Ecological Risks
EPA has determined that remaining uses are eligible for reregistration provided that:
• The maximum # of applications on all labels be reduced to 2 per season during phase out period
for cotton.
The maximum # of applications on all labels be reduced to 4 per season for tomatoes.
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V. What Registrants Need to Do - .
In order to be eligible for reregistmtion, registrants need to implement the risk mitigation
measures outlined in Section IV, which include submission of the following;
A. Data Call-in Responses
For mefliamidophos technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-In (DC!):
(1) completed response forms to the generic DCI (i.e.. DO response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a fell written
justification, 1
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contest Mark Hartman at (703) 303-0734 with questions regarding reregistratlon and/or
die DCI Ail materials submitted in response to tie generic DCI should be addressed:
RyTTS imatl: Bv express or courier service:
* Document Processing Desk (DCFSRRD) Document Processing Desk (DCI/SKRD)
Mark A. Hartman Mark A. Hartman
US EPA (7508C) Office of Pesticide Programs (7508Q
1200 Pennsylvania Ave.. NW - Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient methamidoohos. registrants need to
submit the following items for each product
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (Le., PDCI. response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests wih a full written
justification.
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Within eight mouths from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined
in Table 17 of this document;
(4) a completed form ratifying compliance with data compensation
requirements (EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); aid
(6) the product-specific data responding to the PDCI.
Please contact Bonnie Adler at (703) 308-8523 with questions regarding product reregistration
and/or the PDCI. All materials submitted in response to the PDCI should be addressed:
Rv 1 IS mail: Bv express or courier service onlv:
Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)
Bonnie Adler Bonnie Adler
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of meihamidophos for the above eligible
uses has been reviewed and determined to be substantially complete. The following data gaps remain:
1. Drinking water monitoring data for surface water sources for methamidophos in potato and
tomato growing regions. This data is requested in order to confirm that the level of
methamidophos is lower than predicted in the Agency's water models (OPPTS 167-1-SS)
2. Chronic Estuarine Invertebrate Study using Mysid shrimp (OPPTS 850.1350)
3. Photolysis on Soil (OPPTS 835.2410)
4. Anaerobic Aquatic Metabolism (OPPTS 835.4400)
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5. Teirestriai Field Dissipation (OPPTS 835,6100)
6. Daphnid Chronic Toxicity Study (OPPTS 850.1300) ¦ •
7. Teirestriai Plant Toxicity, Seedling Emergence (OPPTS 850.4100)
8. Terrestrial Plant Toxicity, Vegetative Vigor (OPPTS 850.4150)
9. Dermal Passive Doslmetiy Exposure (OPPTS 8752400)
10. Mixer/Loader exposure data for dry coupling closed mixing/loading system (OPPTS 875.1100
and 875.1300)
11. Confined Accumulation in Rotational Crops (OPPTS 860.1850)
12. Product ehemisby data requirements for all technical and manufacturing use products have not
been fulfilled. (830 ser!es\60 series)
Also, a Date Call-in Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FIFRA (August 6.1999 64FR42945-42947, August 18'
64FR44922-44923). DCI requirements included acute, subchfonic, and developmental neurotoxicity
studies; the developmental neurotoxicity study is currently in review. Acceptable acute and subchronic
studies have been received and reviewed by the Agency.
2. Labeling for Manufacturing Use Products
To remain in compliance with Flt'KA, manufacturing use product (MUP) labeling should be
revised to compty with all current EPA regulations, PR Notices and applicable policies. Hie MUP
labeling should bear the labeling contained in Table 17 atthe end of this section.
C. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIERA calls .for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has teen made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. If a registrant believes feat previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in fee
Requirement Status and Registrants Response Form provided for each product.
A product-specific data call-in. outlining specific data requirements, accompanies this interim RED.
2, Labeling for End-Use Products
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Labeling changes are necessary to implement the mitigation measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Table 17 at the end of this
section.
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this interim RED. Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this interim RED.
However, existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrant may distribute and sell methamidophos products
bearing old labels/labeling for 26 months from the date of issuance of this interim RED. Persons other
than the registrant may distribute or sell such products for 50 months from the date of the issuance of
this interim RED. Registrants and persons other than the registrant remain obligated to meet pre-
existing label requirements and existing stocks requirements applicable to products they sell or
distribute.
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E. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.
Table 17: Summary of Labeling Changes for methamidophos
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
Formulation Instructions
required on all MUPs
"Only for formulation into an insecticide for the following use(s): alfalfa grown for seed, cotton,
tomatoes and potatoes."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by
a formulator or user group
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label if
the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
Directions for Use
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Description
Amended Labeling Language
Placement on Label
Environmental Hazards
Statements Required by
Agency Label Policies
"Environmental Hazards"
"This chemical is extremely toxic to birds, mammals, and aquatic invertebrates. Do not discharge
effluent containing this product into lakes, streams, ponds estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit
and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your state Water Board or Regional Office of the EPA."
Precautionary Statements
under Environmental
Hazards
End Use Products Intended for Occupational Use (WPS)
Restricted Use Pesticide
"RESTRICTED USE PESTICIDE"
Due to Acute Toxicity. "For retail sale to and use only by certified applicators or persons under their
direct supervision, and only for those uses covered by the certified applicator's certification."
Top of Front Panel
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Description
Amended Labeling Language
Placement on Label
Handler PPE requirements
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-
resistant material). "If you want more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G,or II\ "on an EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators, and flaggers using engineering controls must wear:
Long-sleeved shirt and long pants
Shoes plus socks
In addition, mixers and loaders must wear chemical-resistant gloves and a chemical resistant apron."
"See engineering controls for additional requirements.
"Handlers engaged in those activities for which use of an engineering control is not possible, such as
cleaning up a spill or leak and cleaning or repairing contaminated equipment, must wear:
Coveralls over long-sleeved shirt and long pants,
Chemical-resistant gloves,
Chemical resistant footwear plus socks,
Chemical-resistant headgear if overhead exposure,
In addition, handlers exposed to the concentrate must wear:
A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSII
approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge
or canister with any N, R or P or He prefilter;
Chemical-resistant apron"
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
67
-------
Description
Amended Labeling Language
Placement on Label
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with
this product's concentrate. Do not reuse them."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
68
-------
Description
Amended Labeling Language
Placement on Label
Engineering Controls
"Engineering Controls
"Mixers and loaders must use a closed system that provides dermal and inhalation protection and must use and
maintain this system in a manner that meets the requirements specified in the Worker Protection
Standard for Agricultural Pesticides [40 CFR 170.240(d)(4)]. The system must be capable of removing the
pesticide from the shipping container and transferring it into mixing tanks and/or application equipment. At any
disconnect point, the system must be equipped with a dry disconnect or dry couple shut-off device that is warranted b;
the manufacturer to minimize drippage to not more than 2 mL. per disconnect point." Mixers and loaders must
also:
-- wear the personal protective equipment required above for mixers/loaders using engineering
controls,
— wear protective eyewear if the system operates under pressure, and
— be provided and have immediately available for use in an emergency, such as a broken
package, spill, or equipment breakdown the PPE specified above for handlers engaged in those
activities for which use of an engineering control is not possible."
"Applicators using motorized ground equipment and flaggers supporting aerial applications must use an
enclosed cab that meets the definition in the Worker Protection Standard for Agricultural Pesticides [40
CFR 170.240(d)(5)] for dermal protection. In addition, such applicators and flaggers must:
— wear the personal protective equipment required above for applicators using engineering
controls,
— be provided and must have immediately available for use in an emergency when they must
exit the cab in the PPE specified above for handlers engaged in those activities for which use of
an engineering control is not possible.
-- take off any extra PPE that was put on and worn in the treated area before reentering the cab,
and
— store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent
contamination of the inside of the cab."
"Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker
protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];"
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following
PPE and User Safety
Requirements.)
69
-------
Description
Amended Labeling Language
Placement on Label
User Safety
Recommendations
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing*. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"This pesticide is extremely toxic to birds, mammals, and aquatic invertebrates. Do not apply directly
to water, or to areas where surface water is present or to intertidal areas below the mean high-water mark.
Drift and runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water
when disposing of equipment washwater or rinsate."
"This product may contaminate water through drift of spray in wind. This product has a high potential
for runoff. Poorly draining soils and soils with shallow watertables are more prone to produce runoff
that contains this product."
"This pesticide is toxic to bees. Application should be timed to coincide with periods of minimum bee
activity, usually between late evening and early morning."
Precautionary Statements
immediately following the
User Safety
Recommendations
70
-------
Description
Amended Labeling Language
Placement on Label
Restricted-Entry Interval
(all products except those
listed below)
"Do not enter or allow workers to enter into treated areas during the restricted entry interval (REI).
The REI for cotton and alfalfa is is 48 hours. The REI for cotton and alfalfa is 72 hours in areas where
average rainfall is less than 25 inches a year.
The REI for potatoes is 4 days.
Directions for Use,
Agricultural Use
Requirements Box
Special Local Needs
Registrations in California
(CA78016300;
CA79009600)
The REI for tomatoes is 3 days.
71
-------
Description
Amended Labeling Language
Placement on Label
Special Local Needs
The REI for tomatoes is 4 days.
Registrations in states other
than California
(AL89000800;
AR97000400;
DE91000200; DE92000200;
FL80004600; FL89000700;
FL89004100; FL90000300;
FL92000400; GA86000400;
GA90000100; IN79000100;
IN93000300; LA91000800,
LA99001100;
MD91000900;
MI78001600; MI93000300;
NC89000700; NJ96001000;
OH79000800;
OH79001000; PR92000100;
SC78001600; TN89000700;
TN93000300; TN96000600;
TX91001200; TX91001600;
VA91000500;
VA93000200)
72
-------
Description
Amended Labeling Language
Placement on Label
Early Re-entry Personal
Protective Equipment
established by the IRED,
Early Entry PPE (WPS)
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
* coveralls worn over long-sleeve shirt and long pants,
* chemical-resistant gloves made of any waterproof material,
* chemical-resistant footwear plus socks, and
* chemical-resistant headgear (if overhead exposure)
* protective eyewear"
~~"Notify workers of the application by warning them orally and by posting warning signs at entrances
to treated area,"
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application."
Place in the Directions for
Use directly above the
Agricultural Use Box.
Other Application
Restrictions
Crop-Specific Application Restrictions (labels must be amended to reflect the requirements specified
below)
All Crops: An advisory that application of methamidophos products after applications of acephate may
result in illegal residues.
Tomatoes: The different use directions for tomatoes destined to be processed is not considered to be
practical and must be removed from the label.
Cotton: The cotton grazing/feeding restrictions are not considered practical and must be removed,
Cotton: Maximum number of applications per season is two.
Directions for Use
73
-------
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions (SLNs)
Tomatoes: Maximum number of applications per season is four.
Other Application
Restrictions (SLNs currently
w/ < 3 apps)
Tomatoes: Maximum number of applications per season is two.
Spray Drift Restrictions
for Outdoor Products
Applied as a Liquid
"Do not allow spray to drift from the application site and contact people, structures people occupy at
any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland
areas, woodlands, pastures, rangelands, or animals."
Directions for Use in
General Precautions and
Restrictions
Spray Drift language
"Aerial Spray Drift Management"
" For aerial applications, the boom width must not exceed 75% of the wingspan or 90% of the rotary
blade. Use upwind swath displacement and apply only when wind speed is 3-10 mph at the application
site as measured by an anemometer. Use (registrant to fill in blank with spray quality, e.g. fine or
medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning
atomizer nozzles. If application includes a no-spray zone, do not spray at a height greater than 10 feet
above the ground or the crop canopy."
"For overhead chemigation, apply only when wind speed is 10 mph or less."
"For ground boom applications, apply with nozzle height no more than four feet above the ground or
crop canopy and when wind speed is 10 mph or less at the application site as measured by an
anemometer. Use (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser
spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles.
"The applicator also must use all other measures necessary to control drift."
Directions for Use in
General Precautions and
Restrictions
74
-------
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document.
The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
2 If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped.
Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label.
Instructions in the Labeling section not in quotes represents actions that the registrant should take to amend their labels or product registrations.
75
-------
VL Related Documents and How to Access Them
This interim Reregistralion Eligibility Document is supported by documents that are presently
maintained in the OPP docket. The following sections indicate the means to view or obtain copies of paper
or electronic versions of these documents and lists titles of documents that are now in the docket files.
A. Availability at OPP Docket Room
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 p.m.
The docket initially contained preliminary risk assessments and related documents as of 1999.
Sixty days late 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 February 22,2000.
B. Availability on the Internet
Many of the supporting documents may be viewed or downloaded from the Internet. The web site
is as follows: http://www.epa.gov/oppsrrd 1 /op/.
76
-------
VII. Appendices
77
-------
Intentionally Blank Page
78
-------
Appendix A. Use Patterns Eligible for Rcrcgistration
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate (ai)
Maximum
Number of
Applications Per
Season
Maximum Seasonal
Rate (ai)
Preharvest
Interval,
(Days)
Use Directions and Limitations
Alfalfa
Foliar
Ground or aerial
4 lb/gal EC
[CA980013]
1.0 lb/A
1
1.0 lb/A
N/A
Applications may be made in a
minimum of 25 gal/A by ground,
3 gal/A by air. Do not feed refuse
to livestock. Alfalfa seed from
treated fields may not be used for
growing sprouts for human or
animal consumption. Do not
apply through any type of
irrigation system.
Cotton
Foliar (Before bolls open)
Ground or aerial
4 lb/gal EC
[3125-280]
[AR870007]
[MS810014]
1.0 lb/A
2
2.0 lb/A
50
Applications may be made in a
minimum of 25 gal/A by ground,
3 gal/A by air, or by irrigation
systems. The feeding of gin trash
to livestock or grazing of
animals on treated fields is
prohibited.
4 lb/gal EC
[59639-56]
1.0 lb/A
2
2,0 lb/A
50
Applications may be made in a
minimum of 25 gal/A by ground
or 3 gal/A by air. The feeding of
gin trash to livestock or grazing
of animals on treated fields is
prohibited.
79
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate (ai)
Maximum
Number of
Applications Per
Season
Maximum Seasonal
Rate (ai)
Preharvest
Interval,
(Days)
Use Directions and Limitations
Foliar
Ground or aerial
4 lb/gal EC
[AR810044]
[AR890005]
[CA780189]
[CA790188]
[LA830018]
[MS810055]
[MS830013]
[TN880004]
1.0 lb/A
2
2.0 lb/A
NS
Use limited to AR, CA, LA, MS,
and TN. Applications after 65%
of the bolls are open are
prohibited. Applications may be
made in a minimum of 25 gal/A
by ground or 1 gal/A by air
(MS810055 only). The feeding of
gin trash to livestock or grazing
of animals on treated fields is
prohibited.
Potato
Foliar
Ground or aerial
4 lb/gal EC
[3125-280]
[59639-56]
1.0 lb/A
4
4.0 lb/A
14
Applications may be made in a
minimum of 25 gal/A by ground,
3 gal/A by air, or by sprinkler
irrigation systems with a
retreatment interval of 7- to 10-
days as a preventative program or
as needed.
Tomato
Foliar
Ground
4 lb/gal EC
[FL890041]
1.0 lb/A
4
4.0 lb/A
7
Tank mix use limited to FL.
80
-------
j Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate (ai)
Maximum
Number of
Applications Per
Season
Maximum Seasonal
Rate (ai)
Preharvest
Interval,
(Days)
Use Directions and Limitations
4 lb/gnl EC
[FL920004]
1.0 lb/A
4
4.0 lb/A
7
Use limited to FL. Applications
may be made in a minimum of 25
gal/A by ground with a
retreatment interval of 5- to 7-
days.
4 lb/gal EC
[IN790001]
[IN930003]
[MI780016]
[MI930003]
[OH790008]
[OH790010]
1.0 lb/A
3
3.0 lb/A
7
Use limited to IN, MI, and OH.
Applications may be made in a
minimum of 25 gal/A by ground
with a retreatment interval of 7-
to 10-days.
4 lb/gal EC
[SC780016]
1.0 lb/A
4
4.0 lb/A
14
Use limited to SC. Applications
may be made in a minimum of 50
gal/A by ground with a
retreatment interval of 7- to 10-
days.
4 lb/gal EC
[AL890008]
0.75 lb/A
4
3.0 lb/A
7
Use limited to AL and GA.
Applications may be made in a
minimum of 25 gal/A by ground
with a retreatment interval of 5-
to 7-days.
81
-------
Site.
Application Type
Application Timing
Application Equipment
Formulation
(EPA Reg. No.]
Maximum Single
Application Rate (ai)
Maximum
Number of
Applications Per
Season
Maximum Seasonal
Rate (ai)
Preharvest
Interval,
(Days)
Use Directions and Limitations
4 lb/gal EC
[PR920001]
0,75 lb/A
4
3.0 lb/A
7
Use limited to PR. Applications
may be made in a miruxnum of 25
gal/A by ground with a
retreatment interval of 7- to to-
days.
Foliar
Ground or aerial
4 lb/gal EC
[TX910016]
1.0 lb/A
4.0 lb/A
14
Use limited to TX. Applications
may be made alone or as a tank
mix witli a pyrethroid.
Applications may be made in a
minimum of 25 gal/A by ground
or 5 gal/A by air with a
retreatment interval of 7- to 10-
days.
4 lb/gal EC
[FL800046]
[FL890007]
[I.A910016]
[1X910012]
1,0 lb/A
4
4,0 lb/A
7
Use limited to FL, LA, and TX.
Applications may be made in a
minimum of 25 gal/A by ground
or 3 gal/A by air with a
retreatment interval of 7- to 10-
days.
82
-------
Site
Application Type
Maximum
Number of
Preliarvcst
Application Timing
Formulation
Maximum Single
Applications Per'
Maximum Seasonal
Interval,
Application Equipment
[EPA Reg. No.]
Application Rate (ai)
Season
Rate (ai)
(Days)
Use Directions and Limitations
4 lb/gal EC
1.0 lb/A
4
4.0 lb/A
7
Use limited to AR, CA, DE, LA,
[AR970004]
[CA780163]
[CA790096]
[DE910002]
MD, NC, NJ, TN, and VA.
Applications may be made in a
minimum of 25 gal/A by ground
or 5 gal/A by air with a
retreatment interval of 7- to 10-
[DE920002]
days.
[LA910008]
[MD910009]
[NC890007]
[NJ900006]
[NJ960010]
[TN890007]
[TN930003]
[TN960006]
[VA910005]
[VA930002]
Foliar
4 lb/gal EC
1.0 lb/A
4
4.0 lb/A
14
Use limited to CA for processing
Ground or aerial
¦
[CA780163]
tomatoes. Applications may be
made in a minimum of 25 gal/A
by ground or 5 gal/A by air with
a retreatment interval of 7- to 10-
days.
83
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84
-------
Appendix B:
Data Supporting Guideline Requirements for the Reregistration of Methamidophos
REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
New Guideline Old Guideline
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
Number
61-1
158-160
61-2A
158-165
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
Product Identity and
Composition
Description of Materials Used
to Produce Product
Start. Mat. & Mnfg. Process
Description of Formulation
Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Stability
A, B 00014037, 43661001, Data Gap
A, B Data Gap
A, B 00014024, 43661001, Data Gap
A, B Data Gap
A; B 00014024, 43661001, Data Gap
A, B 00014024,43661002, Data Gap
A, B 00014024,43661002, Data Gap
A, B 00014023, 00014025-00014030, 00014032,
00014033,43661001, Data Gap
A, B 00014021,43661001, 43661003, Data Gap
A, B 00014021,43661001,43661003, Data Gap
A, B 00014021,43661001, 43661003, Data Gap
A, B 00014021, Data Gap
85
-------
REQUIREMENT
830.6314
63-14
Oxidizing/Reducing Action
830.6315
63-15
Flammability
830.6316
63-16
Explodability
830.6317
63-17
Storage Stability
830.6319
63-19
Miscibility
830.6320
63-20
Corrosion Characteristics
830.6321
158-165
Dielectric Breakdown Voltage
830.7000
63-12
pH
830.7050
None
UV/Visible Absorption
830.7100
63-18
Viscosity
830.7200
63-5
Melting Point
830.7220
63-6
Boiling Point
830.7300
63-7
Density
830.7370
63-10
Dissociation Constant
830.7550
63-11
Octanol/Water Partition
Coefficient
830.7840
63-8
Solubility
830.7860
USE PATTERN CITATION(S)
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B 00014021, Data Gap
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B 43661001, 43661003, Data Gap
A, B 43661001,43661003
A, B 00014021, 43661001,43661003, Data Gap
A, B 43661003, Data Gap
A, B 43661003, Data Gap
A, B 00014021,43661001,43661003
86
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REQUIREMENT
USE PATTERN CITATION(S)
830.7950 63-9 Vapor Pressure
ECOLOGICAL EFFECTS
850.1010 72-2A Invertebrate Toxicity
850.1075
850.1075
850.2100
850.2200
850.2300
850.2300
None
850.1025
72-1A
72-1C
71-1
850.2200 71-2A
71-2B
71-4A
71-4B
72-3A
72-3B
850.1035 72-3C
850.1300 72-4A
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Estuarine/Marine Toxicity -
Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Daphnid Chronic Toxicity
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
00014021, 4361001, 43661003
00041311,00014110,00014305
00041312, 00144432, 44484402, 00014063
00041312, 00144429, 00144432, 00014063
00014094, 00014095, 00041313, 00093914,
00109717, 00109718, 00144428
00093904, 00014304,00145655, 00130823,
00014064, 44484404
00041658,00130823,00014304, 00145655,
44484403
00014114
00014113
00144431
40088601
00144430
Data Gap
87
-------
REQUIREMENT
850.1350 72-4B
850.4100 122-1
850.4150 122-1
850.3020 141-1
TOXICOLOGY
870.1100 81-1
870.1200 81-2
870.1300 81-3
870.2400 81-4
870.2500 81-5
870.2600 81-6
870.3100 82-1A
870.3150 82-1B
870.3200 82-2
870.3700 83-3A
Estuarine/Marine Invertebrate
Life Cycle
Terrestrial Plant Toxicity
(Seedling Emergence)
Terrestrial Plant Toxicity
(Vegetative Vigor)
Honey Bee Acute Contact
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-
Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
Developmental Toxicity - Rat
USE PATTERN CITATTON(S)
A, B Data Gap
A, B Data Gap
A, B Data Gap
A, B 00036935
A, B 00014044, Data Gap
A, B 00014049, Data Gap
A, B 00148449, Data Gap
A, B 00014221, Data Gap
A, B 00014220, Data Gap
A, B 00147929, Data Gap
A, B 00014155
A, B 00014153
A, B 44525301
A, B 00148454, 43906901
-------
REQUIREMENT
USE PATTERN CITATION(S)
870.3700 83-3B
870.3800 83-4
870.3465 82-4
870.4100 83-1B
870.4300
870.4200
870.6100
870.6200
None
None
83-1A/
83-2A
83-2B
81-7
81-8
82-1SS
82-5A
None 82-5B
870.5140 84-2
Developmental Toxicity -
Rabbit
2-Generation Reproduction -
Rat
90-Day Inhalation-Rat
Chronic Feeding Toxicity -
Non-Rodent
Combined Chronic Toxicit/
Carcinogenicity - Rodent
Oncogenicity - Mouse
Acute Delayed Neurotoxicity -
Hen
Acute Neurotoxicity Screen
8-Week Subchronic Oral
Toxicity Cholinesterase Study -
Rodent
90-Day Delayed Neurotoxicity
- Hens
90-Day Neurotoxicity - Rat
Gene Mutation (Ames Test)
A, B 00041315,44040601
A, B 00148455, 41234301, 44466001, 44815401,
44815402
A, B 41402401
A, B 00147938,41234304
A, B 00148952,43248102
A, B 00145579,00147937,43248101
A, B 00041317
A, B 43025001,43345801
A, B 41867201
A, B 40985202
A, B 43197901
A, B 00098457
89
-------
REQUIREMENT
Structural Chromosomal
Aberration
Gene Mutation - Mammalian
Cells
Other Mutagenic Mechanisms
- in vitro
870.6200 82-7 Subchronic Neurotoxicity
Screening Study - Rodent
870.6200 82-7 Subchronic Oral Delayed
Neurotoxicity - Hen
870.7485 85-1 General Metabolism
OCCUPATIONAL/RESIDENTIAL
EXPOSURE
875.2100 132-1A
875.2200 132-1B
875.2400 133-3
875.2500 133-4
875.1100 231
870.5375 84-2
870.5300 84-2
870.5900 84-2
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry
Exposure
Inhalation Passive Dosimetry
Exposure
Estimation of Dermal
Exposure at Outdoor Sites
USE PATTERN CITATION(S)
A, B 41234306,41461401
A, B 42854701
A, B 41234305
A, B 43197901
A, B 40985202
A, B 00015224
A, B 40985203, 44685501, 44685502, 44685503
A, B Waived
A, B Data Gap
A, B Waived
A, B Data Gap
-------
REQUIREMENT
USE PATTERN CITATK)N(S)
875.1300 232 Estimation of Inhalation
Exposure at Outdoor Sites
ENVIRONMENTAL FATE
835.1240 163-1 Lcaching/Adsorption/Desorpti
on
860.1850 165-1 Confined Rotational Crop
835.2120 161-1 Hydrolysis
835.2240 161-2 Photodcgradation - Water
835.2410 161-3 Photodegradation - Soil
835.4100 162-1 Aerobic Soil Metabolism
835.4200 162-2 Anaerobic Soil Metabolism
835.4300 162-4 Aerobic Aquatic Metabolism
835.4400 162-3 Anaerobic Aquatic
Metabolism
163-2 Volatility
835.6100 164-1 Terrestrial Field Dissipation
None 165-4 Bioaccumulation in Fish
None 167-1-SS Drinldng Water Monitoring
RESIDUE CHEMISTRY
A, B Data Gap
A, B 40504811
A, B 42758701, Data Gap
A,B 00150609
A, B 00150610
A, B 00150611, Data Gap
A, B 41372201
A, B 43541202
A, B Data Gap (can be fulfilled by 835.4400)
A, B 43541202, Data Gap
A, B 40985206
A, B 40985206,43541201, Data Gap
A, B 00014015
A, B Data Gap
91
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REQUIREMENT
860.1300 171-4A
860.1300 171-4B
860.1340 171-4C
860.1340 171-4D
860.1380 171-4E
860.1480 171-4J
860.1500 171-4K
860.1500 171-4K
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method -
Plants
Residue Analytical Method -
Animals
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry
/Egg (Milk and the Fat, Meat,
and Meat Byproducts of
Cattle, Goats, Hogs, Horses,
and Sheep)
Crop Field Trials-Root and
Tuber Vegetables Group
(Beets, sugar, roots)
Crop Field Trials-Root and
Tuber Vegetables Group
(Potatoes)
USE PATTERN CITATION^)
A, B 00014077, 00014081, 44209701, 44209702
A, B 00014555, 00014995, 00015222, 4429703,
44209704
A, B 00014085, 44209705, 44209706
A, B 44209707, 44209708
A, B 44514302
A, B 00015183,00015225
A, B 00013677,00014266,00014269
A, B 00014075,40747301,44512201
92
-------
REQUIREMENT
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
Crop Field Trials-Leaves of
Root and Tuber Vegetables
Group (Beets, sugar, tops)
Crop Field Trials-Leafy
Vegetables (except Brassica)
Vegetables Group (Lettuce)
Crop Field Trials-Brassica
(Cole) Vegetables Group
(Broccoli)
Crop Field Trials-Brassica
(Cole) Vegetables Group
(Brussels sprouts)
Crop Field Trials-Brassica
(Cole) Vegetables Group
(Cabbage)
Crop Field Trials-Brassica
(Cole) Vegetables Group
(Cauliflower)
Crop Field Trials-Fruiting
Vegetables (Except Cucurbits)
Group (Eggplant)
use pattern CITATIQN(S)
A, B 00013677,00014266,00014269
A, B 00014073
A, B 00014069
A, B 00014070
A, B 00014071
A, B 00014072
A, B 00014119,00014120,00014130,00014131
93
-------
REQUIREMENT
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
860.1520 171-4L
860.1520 171-4L
860.1520 171-4L
Crop Field Trials-Fruiting
Vegetables (Except Cucurbits)
Group (Pepper)
Crop Field Trials-Fruiting
Vegetables (Except Cucurbits)
Group (Tomato)
Crop Field Trials-Cucurbits
Vegetables Group (Cucumber)
Crop Field Trials-Cucurbits
Vegetables Group (Melon)
Miscellaneous Commodities-
Cotton, Seed and Gin
Byproducts
Processed Food/Feed (Cotton,
seed)
Processed Food/Feed (Potato)
Processed Food/Feed (Tomato)
USE PATTERN CITATION(S)
A, B 00014121, 00014122, 00014123, 00014140
A, B 00014124-00014129, 40007401,44514301
A, B 00014132, 00014133, 00014138, 00014139
A, B 00014134,00014135
A, B 00014074,44558801
A, B 41966302
A, B 44815406
A, B 40007401
94
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Appendix C: Technical Sapper* Documents
Additional documentation in support of this RED is maintained in the OPP docket, 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 8,
1999., 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 February 3,2000.
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:
www.epa.gov/pestieides/op
These documents include:
• Methamidophos: Revision ofEFED Risk Assessment for the Reregisfcation Eligibility
Decision (RED) Document to Include Registrant's Comments.
* EFED Response to Comments Submitted to the Methamidophos Docket During the 60-
day Comment Period on the EFED Methamidophos RED Chapter.
• Methamidophos: HED Risk Assessment and Disciplinary Chapters for the Reregistration
Eligibility Decision (RED) Document List A Reregistration Case 0043. ChemealNo.
101201. DP Barcode: D250644. October 30,1998
Human Health Risk Assessment Methamidophos. February 3,2000
* Methamidophos Summary. December 2,1999
• Overview of the Revised Methamidophos Risk Assessment. January 13, 2000
Acephate and Methamidophos: Technical Briefing. February 3,2000
* Methamidophos: Revised Toxicology Chapter for RED. February 3,2000
« Final Usage Analysis for Methamidophos RED.
95
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Methamidophos. List A Case No, 0043. Chemical No. 101201, Revised Dietary
Exposure and Risk Analyses few the HED Revised Human Health Risk Assessment and
HED Review of the Bayer Corporation Probabilistic (Monte Carlo) Acute Dietary
Exposure Assessment, DP Barcodes D256039, D256042. MRID No. 448154-10.
October 4,1999
Methamidophos: Revised Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document. PC Code 101201;
DP Barcode: D258447. August 9,1999
Review of Methamidophos Incident Reports. DP Barcode D258608, Chemical #101201.
October 5,1999
Methamidophos List B Reregistration Case No. 0043/Chemical ID No. 101201.
Response to Comments to the Draft Methamidophos Reregistration Eligibility Decision
(RED) Document. DP Barcode D254708. August 18,1999
Response to Public Comments on the Preliminary Risk Assessments for the
Grganophosphate Methamidophos. February 16,2000
Methamidophos: Review of 21-day Dermal Toxicity in Rats (MRID No. 44525301 and
Addendum to MRID No. 4452530l)/Short- and Intermediate- Term Dermal Risk
assessments. May 18,1999
Methamidophos: Review of Two Generation Reproduction Toxicity Study in Rats (MRID
No. 4466001 and Addenda MRID No. 44815402)/Impact on Dietary and Non-dietary
Risk Assessments. June 16,1999
Methamidophos: Review of Potato Processing Study; Chemical ID No. 101201;
Reregistration Case No. 0043; MRID No. 44815406; DP Barcode D256034.
August 11, 1999
Methamidophos. Chemical ID No. 101201. Sensitivity Analysis. November 29,
1999
96
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Appendix D; BIMography
carrot TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. TMs bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document Primary sources fir studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of fast regulatory decisions. Selections
. from other sources including the published literature, in those instances where they have been ,
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
• published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, die Agency has sought to identify documents at a level parallel to "fee
published article from within fee typically large* volumes in which they were submitted The resulting
"studies" generally have a distinct title (or 'at least a single subject), can stand alone for purposes of
review and can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master-Record Identifier, or "MRID" number. This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to fee six-digit "Accession Number"
which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further
explanation), hi a few cases, entries added to the bibliography late in the review may be preceded by
a nine character temporaiy identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to fee Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in fee case of material submitted to EPA, by a
description of fee earliest known submission. Bibliographic conventions used reflect the standard of
the American National Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever fee author could confidently be identified, fee Agency has chosen to show a
personal author. When no individual was identified, fee Agency has shown an identifiable
laboratory or testing fecility as the author. When no author or laboratory could be identified, the
Agency has shown fee first submitter as the author.
b. Document date. Hie date of fee study is taken directly from the document. When the date Is
followed by a question mark, the bibliographer has deduced fee date from the evidence contained
in fee document When fee date appears as (1999), fee Agency was unable to determine or
estimate fee date of fee document
c. Title, hi some cases, it has been necessary for the Agency bibliographers to create or enhance a
97
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document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text) the following elements describing the earliest
known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately Mowing the word "under" is the
registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses
identifies the EPA accession number of the volume in which the original submission of the
study appears. The six-digit accession number follows the symbol "CDL," which stands
for "Company Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
98
-------
mrjod Citation
08013677 Moras Laboratories, Incorporated (1976) Chemagro Agricultural
Division—Mobay Chemical Corporation Residue Experiment: 462-5746-75D:
Report No, 49920. (Unpublished study including report nos. 49921,50S44 ami
50845, received Aug 24,1978 under 3125-280; submitted by Mobay Chemical
Corp., Agricultural Div., Kansas City, Mo.; CDL:C9731S-H)
00014015 Baychem Corporation (1972) Chemagro, Division of Baychem Corporation,
Residue Experiment; Report No. 31933. (Unpublished study received on
BTiknoTFii date under 0FGS56; submitted by Chevron Chemical Co., Richmond,
Calf.; CBL:C93266-G)
00014821 • Chevron Chemical Company (1970) Monitor Insecticide Residue Tolerance
Petition: Physical and Chemical Properties. (Unpublished study received Mar 5,
197© under ©F0956; CDL:093266-M)
GOO14923 Hay-man, E.L. (1969) Monitor by Gas Chromatography. Method dated
Oct 16,1969. (Unpublished study received Mar 5,1970 under
GF0956; submitted by Chevron Chemical Co., Richmond, Calf.;
CDL:693266-Q)
00014024 Chevron Chemical Company (19??) Monitor Insecticide Residue Tolerance
Petition: Manufacturing Process, (Unpublished study received Mar 5,1970
under 0F0956; CDL:093266-R) "
06014-025 Leary, J.B. (1969) Determination of Monitor Insecticide and the Thlone Isomer
Impurity In Technical Monitor Insecticide. Method dated Apr '23,1969.
(Unpublished study received Mar 5,1970 under ©F0956; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093266~S)
00014026 Leary, J.B. (1968) Determination of N,0,S-Trim ethyl phosphoramMothioate in
Monitor Insecticide. Method dated Jan 13,1968. (Unpublished study received
Mar 5,1970 under 0F0956; submitted fay Chevron Chemical Co., Richmond,
Calif.; CDL: 093266-T) "
00014027 Leaiy, J.B. (1968) Determination of N,0,G-Trimethyl phosphcramidothioats m
Monitor Insecticide. Method dated Jan 13,196S. (Unpublished study received
Mar S, 1970 under GF0956;1 submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:C93266-U)
00014028 Leary, J.B. (1969) Determination of Oj-S-Dlmsthyl phosphsrothloate in Monitor
99
-------
Insecticide. Method dated Dec 12,1969. (Unpublished study received Mar 5,
1970 under 0F0956; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093266-V)
00014029 Leary, J.B. (1968) Determination of Dimethyl sulfate in Monitor Insecticide.
Method dated Jun 13,1968. (Unpublished study received Mar 5,1970 under
0F0956; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:093266-W)
00014030 Leary, J.B. (1970) Determination of Methyl sulfuric acid in Monitor Insecticide.
Method dated Jan 21,1970. (Unpublished study received Mar 5,1970 under
0F0956; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:093266-X)
00014032 Leary, J.B. (1968) Determination of N, N, O, S -Tetramethyl
phosphoramidothioate in Monitor Insecticide. Method dated Jun 13,1968.
(Unpublished study received Mar 5,1970 under 0F0956; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093266-Z)
00014033 Leary, J.B. (1968) Determination of N, N, O, O-Tetramethyl
phosphoramidothioate in Monitor Insecticide. Method dated Jun 13,1968.
(Unpublished study received Mar 5,1970 under 0F0956; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093266-AA)
00014037 Chevron Chemical Company (19??) Monitor Insecticide Residue Tolerance
Petition: Name and Chemical Identity. (Unpublished study received Mar 5,1970
under 0F0956; CDL:093266-AF)
00014044 Cavalli, R.D.; Hallesy, D.W. (1968) Acute Oral Toxicity ofRE 9006 (95%) in
Rats: SOCO 14/1:87. (Unpublished study received Mar 5,1970 under 0F0956;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:093265-B)
00014049 Cavalli, R.D.; Hallesy, D.W. (1968) Acute Dermal Toxicity of Monitor
Technical: SOCO 30/1:121-8. (Unpublished study received Mar 5,1970 under
0F0956; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:093265-G)
00014063 Schoenig, G. (1968) Report to Chevron Chemical Company, Ortho Division:
Four-Day Fish Toxicity Study on Monitor (RE-9006) 75% Technical SX-171:
IBT No. A6482. (Unpublished study received Mar 5,1970 under 0F0956;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093265-W)
00014064 Jackson, G.L. (1968) Report to Chevron Chemical Company, Ortho Division:
Quail Toxicity of Monitor (RE 9006): IBT No. J6483. (Unpublished study
100
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received Mar 5,1970 under 0F0956; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif;
CDL;093265-X)
00014869 Mayberry, T.W.; Sakamoto, S.S.; Leary, J.B.: et al. (1969) Residue Data Sheet:
Broccoli (Unpublished study received Mar 5,1970 under 0F0956; submitted by
Chevron Chemical Co., Richmond, Call; CDL:093264-B)
00014070 CineresM, J.E.; Leaiy, J.B.; Sakamoto, S.S.; et al. (1969) Residue Data Sheet;
Brussels Sprouts. (Unpublished study received Mar 5,1970 under 0F0956;
submitted by Chevron Chemical Co., Richmond, Calif,; CDL:093264-1)
.©0014671 Cmsreski, J.E.; Leary, J.B.; Mayberry, T.W.; et al (1969) Residue Data Sheet:
Cabbage. (Unpublished study received Mar 5,1970 under 0F0956; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:093264-L)
¦ 00014072 Mayberry, T.W.; Sakamoto, S.S.; Leaiy, J.B.; et al. (1970) Residue Data Sheet:
Cauliflower. (Unpublished study received Mar 5,1970 under 0FO956; submitted
by Chevron Chemical Co., Richmond, Calif,; CDL:093264-R) .
00014073 Sakamoto, S.S.; Leary, J.B.: Hatch, M,; et al. (1969) Reslflne Data Sheet:
Lettuce. (Unpublished study received Mar 5,1970 under GF0956; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL;093264-W)
00014074 Sakamoto, S.S.; Kslens, K.J.; Wlthsrspoon, B. (1969) Residue Data Sheet:
Cotton. (Unpublished study received Mar 5,1970 under GF0956; submitted by
Chevron Chemical Co., Richmond, Calif.; CBL:093264-AC) .
00014075 Gerber, CtaJEl., Leary, J.B., Sakamoto, S.S. (1970) Bl esidoe X^ata. Sheet: Potatoes.
(Unpublished study received Mar 5,1970 under 0F0956; submitted by Chevron
Chemical Co., Richmond, Calif,; CDL:093264-AG)
00014077 Chevron Chemical Company (1968) Metabolism of Monitor Insecticide
by Plants. (Unpublished study received Mar 5,1970 under 0F0956;
' CEL:093264-AO)
00014081 Tutass, H.O. (1968) Uptake and Translocation of Monitor Insecticide
by Tomato, Cabbage and Bean Plants. (Unpublished study received Mar 5,1970
under 0H3956; submitted by Chevron Chemical Co., Richmond. Calif.;
CDL:093264-AU)
00014085 Chevron Chemical Company (1968) Monitor Residue Analysis by Thermionic
101
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Gas Chromatography. Method RM-10 dated May 31,1968. (Unpublished study
Including letter dated Oct 17,1969 from D.E. Pack to Kenneth J. Kalens,
received Mar 5,1970 under 0F0956;CDL:093264-AY)
00014094 Fletcher, D. (1971) Report to Chevron Chemical Company, Ortho Division:
Acute Oral Toxicity Study with Monitor Technical in Bobwhite Quail: IBT No.
J261. (Unpublished study received Mar 22,1972 under 0F0956; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL: 092118-C)
00014095 Fletcher, D. (1971) Report to Chevron Chemical Company, Ortho Division:
Acute Oral Toxicity Study with Monitor Technical in Mallard Ducks: IBT No.
J262. (Unpublished study received Mar 22,1972 under OF0956; prepared by
Industrial Bio-Test laboratories, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL: 092118-D)
00014110 Wheeler, R.E. (1978) 48 Hour Acute Static Toxicity of Monitor
(SX887) to 1st Stage Nymph Water Fleas (Daphnia magna Straus).
(Unpublished study received Sep 15,1978 under 239-2404; submit-
ted by Chevron Chemical Co., Richmond, Cali£; CDL:235153-A)
00014113 Fink, R. (1977) Final Report: One-Generation Reproduction Study- Mallard
Duck: Project No. 149-104; Report No. 54030. (Unpublished study received Apr
9,1979 under 239-2404; prepared by Wildlife International, Ltd. in cooperation
with Glencoe Mills, Inc. and Washington College for Mobay Chemical Corp.,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:238015-B)
00014114 Beavers, J.B.; Fink, R. (1978) One-Generation Reproduction Study- Bobwhite
Quail-Technical Monitor: Final Reports: Report No. 66155. (Unpublished study
received Apr 9,1979 under 239- 2404; prepared by Wildlife International, Ltd. in
cooperation with Glencoe Mills, Inc. and Washington College for Mobay
Chemical Corp., submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:238015-C)
00014119 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Culiacan 2: Report No. 37305. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-D)
00014120 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Culiacan 1: Report No. 37306. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798~E)
102
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Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Culiacan 1: Report No. 37307. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Di?., Kansas City, Mo.; CDL:09379S-F)
Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los MoeMs 1: Report No. 37308. Rev. (Unpublished
study reserved Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CBL:093798-G)
Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los MoeMs 2: Report No. 37309. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Di1/., Kansas City, Mo.; CDL:09379S-H)
Bayehein Corporation (1973) Chemagro Division of Baychem Corporation
Residae Experiment; Culiaean 1: Report No. 37310. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-I)
Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Culiacan 2: Report No. 37311. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:09379S-J)
Baychem Corporation (1973) Chemagro Division of Baydisin Corporation
Residue Experiment: Los Mocfais 1; Report No. 37312. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Dir., Kansas City, Mo.; CDL:893798-K)
Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mocfcis 2: Report No. 37313. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-L)
Baychem Corporation (1973) Cfaemagro Division of Baychem Corporation
Residue Experiment; Los MoeMs It Report No. 37314. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CBL:09379S-M)
Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Moehis 2: Report No. 37315. Rev. (Unpublished
103
-------
study received Jul 20,1973 under 4F1424; submitted by Mo bay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-N)
00014130 Baychem Corporation (1973) Chemagro Division of Baycheni Corporation
Residue Experiment: Los Mochis 1: Report No. 37316. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-O)
00014131 Baycheni Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mochis 2: Report No. 37317. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL;093798-F)
00014132 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mochis 2: Report No. 37318. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-Q)
00014133 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mochis 2: Report No. 37319. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-R)
00014134 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mochis 1: Report No. 37320. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-S)
00014135 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Los Mochis 2: Report No. 37321. Rev. (Unpublished
study received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-T)
00014138 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: Culiacan 2: Report No. 37389. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-W)
00014139 Baychem Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment; Culiacan—1: Report No. 37390. Rev. (Unpublished study
received Jul 20,1973 under 4F1424; submitted by Mobay Chemical Corp.,
Agricultural Div., Kansas City, Mo.; CDL:093798-X)
104
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0001414® Baychem Corporation (1973) Chemagr© Division of Baychem Corporation
Residue Experiment: Cullacan 2: Report No. 37391. Rev. (Unpublished study
received Jul 20,1973 tinder 4F1424; submitted by Mobay Chemical Corp-.
Agricultural Div,, Kansas City, Mo.; CBL:09379S-Y)
001)14153 Loser, E. (1970) Snbchromc Tosicoiogieal Studies on Dogs: (Three-Month
Feeding Experiment): Report Nos. 2164; 27986. (Unpublished study received
Nov 18,1974 under 5F1571; prepared by Farbenfabrlken Bayer, A.G., submitted
by Chevron Chemical Co., Richmond, Calif.: CDL:095i75-F)
00014155 Loser, 1. (1970) Subehronic Tosfcologleal Studies on Rats: (Three-Month
Feeding Experiment): Report Nos, 2165; 28043. (Unpublished study receiyed -
Not 18,1974 under 5F1571; prepared by Farbenfabriken Bayer, A.G., submitted
¦ by Chevron Chemical Co.. Richmond, Calif,; CDL:095175-1)
00014220 Levy, J.E. (1979) The Skin Irritation Potential of Monitor Technical: Socal
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106
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00041312 Nelson, D.L.; Roncy, D.J. (1979) Acute Tosicity of Meniter%(R) Technical to
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' 00098457 Maelade, M.L. (1982) Salmonella Mammalian Microsome Mutagenicity Test
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107
©§041317
00041658
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00130823 Lamb, D.; Burke, M. (1977) Dietary Toxicity of Monitor Technical to Bobwhite
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00144428 Lamb, D.; Roney, D. (1972) Acute Oral Toxicity of Monitor to the Common
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00148952 Reagan, E. (1985) Primary Eye Irritation Study of Saf-Sol Brand Sanitizsr Lot
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§0150610 Chopade, BL (1985) Photodecomposltien of Carbon-14 Methamidophos
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00150611 Chopade, EL: Freessaan, P. (1985) Pfcotodecomposttien of Carbon-14
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109
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40007400 Fujie, G. (1986) Monitor (Methamidophos) Residue on Tomatoes: Laboratory
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40088601 Surprenant, D. (1987) Acute Toxicity of Monitor to Eastern Oysters
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40504811 Pack, D.; Verrips, I. (1988) Freundlich Soil Adsorption/Desorption Coefficients of
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40747301 Koch, D. (1988) Monitor - Magnitude of the Residue on Potatoes: Final Rept.
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40985203 Fujie, G. (1985) Dissipation of DLsIodgeable Methamidophos Residues
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41234301 Hixon, H. (1984) Effect of Methamidophos (Monitor) on Reproduction in Rats:
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41234304 Hayes, R. (1984) One-Year Feeding Study of Methamidophos (Monitor) in Dogs:
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41234305 Curren, R. (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
Monitor Technical: Project ID T5844J80. Unpublished study prepared by
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41234306 Esber, H. (1983) In Vivo Cytogenetics Study in Mice Methamidophos Technical:
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110
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4137220 Panthani, A. (1989) Methamidophos Aerobic Soil Metabolism: Laboratory
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41966302 . Cole, R, (1991) Magnitude of tie Residue on Cotton Seed Processed Parts:
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42758701 Mstiem, G.; Parker, G.; Wendt, S. (1992) Confined Accumulation
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42854701 Bigger, A.; Sigler, C. (1993) CHO/J0GPRT Mutation Assay: Monitor Technical:
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43025001 Sheets, L.; Hamilton, B. (1993) An Acute Oral Neurotoxicity Screening Study
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431979M Hamlton, B. (1994) A Snbehronic Dietary Nenrotoacity Screening Study with
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43248101 Hayes, R. (1994) Oncogenicity Study of Methamidophos Technical (MONITOR)
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Ill
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43740301 Temple, D. And D. Palmer, 1995. An Evaluation of the Effects of Monitor 4
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43906901 AstrofT, A. (1996) A Developmental Toxicity Study with Monitor Technical in the
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44040601 Hoberman, A. (1996) Oral (Stomach Tube) Developmental Toxicity Study of
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44209700 Lai, J. (1997) Validation of the Extraction Efficiency of RM-I2A-9 to Remove
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Ecological Risk Assessment
Allen, jr, B.W., M.C. Barber, S.L. Bird, LA. Burns, J.M. Cheplick, MJ. Fendley, D.R. Hartel,
C.A. Kittner, F.L. Mayer, jr., L.A. Suarez, and S.E. Wooten. 1992. PIRANHA: Pesticide and
Industrial Chemical Risk Analysis and Hazard Assessment, version 3.0. Environmental Research
Laboratory, Office of Research and Development, U.S. Environmental Protection Agency,
Athens, GA.
Bennett, R.S., R. Bentley, T. Shiroyama and J.K. Bennett. 1990. Effects of the Duration and
Timing of Dietary Methyl Parathion Exposure on Bobwhite Reproduction. Environ. Toxicol.
Chem. 9:1473-1480.
116
-------
Bennett, R.SJB.A. Williams, D.W. Schrnedding and J.K. Bennett. 1990. Effects of Dietary
Exposure to Methyl Parsthion on Egg Laying and Incubation in mallards. Environ. Toxicol.
Cherr. 10:501-507.
Bennett, R.S. and L.M. Ganio. 1991. Overview of Methods for Evaluating Effects of Pesticides
on Reproduction in Birds. U.S. EPA, Office of Research and Development, Environ. Res. Lab.,
Corvallis, OR. 106 pages.
Bertem, P.E., R.E. Chiles, Studies on the Inhalation Toxicity of Two Phosphoramidothioate
Insecticides Id Rodents and Qua!!. University of California, School ofPubiic Health, Naval
Biosciences Laboratoiy, Naval Supply Center, Oakland, California
Blus, L J., CIS. Stanley, C J. Kenny, G.W. Pendleton, T.H. Craig, EU. Craig, D.K. Halfbrd,
1989. Effects of organophosphorous Insecticides on Sage Grouse in Southeastern Idaho. J,
Wild'. Manage. 53(4): 1139-1146.
Brewer, L.W., C J. Driver, RJ. Kendall, C. Zenier, and TJB. Lacher, Jr. 1987. The Effects of
Methyl Paratfaion in Ducks and Duck Broods. Environmental Toxicology and Chemisby, Vol. 7,
pp.375-379, 1988.
Barns. L.A. 1997. Exposure Analysis Modeling System (EXAMS II): User's Guide for Version
2.97.5. Ecosystem Research Division, National Exposure Research Laboratory, Office of
Research and Development IIS. Environmental Protection Agency, Athens, GA.
Busby, D.G., L.M. White and PA. Pearce. 1990. Effects of Aerial Spraying ofFerdtrothion on
Breeding WMte-Throated Sparrows. J. Appl. Ecol. 27:743-755.
Cardozo, C. et al. 1986-present. Sampling for Pesticide Residues in California Well Water, Well
Inventory Database. Environmental Hazards Assessment Program, California Department of •
Food and Agriculture, State Water Quality Control Board.
Carsel, RJ?, J.C. Imhof£ P.R. Hummel, JM. Cheplick, and A.S. Donigan, Jr. Undated.PRZM-3,
A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil
Zones: User's Manual for Release 3.1, Draft. National Exposure Research Laboratory, Ofiice-of
Research and Development, U.S. Environmental Protection Agency, Athens, GA.
Clarke Jr., D.R., B.A. Rattner. 1987. OrtheneaToxicity to Little Brown Bats (Myotis lucifiigus):
Acetylehlorinestsrase Inhibition, Coorfinatios Loss, and Mortality. Environ. Toxicol, and Chem.
117
-------
Vol 6 pp. 705-708,
Fleming 1982. Anticholinesterase Poisoning in birds: Field Monitoring and Diagnosis of
Acute Poisoning. Environ. Toxicol. Chan. 1:27-38
Grue, C.E. 1988. Postfledging Survival of European Starlings Exposed as Nestlings to an
Organophosphorous Insecticide. Ecology 69:590-601. 1988
Haegele, MA. and R.K. Tucker. 1974. Effects of 15 Common Environmental Pollutants on
Eggshell Thickness in Mallards and Coturnix. Bull. Environ. Contam. Toxicol. 11:98-102.
Hussain, MA., R.B. Mohamad, P.C. Oloffs. 1985. Studies on the Toxicity, Metabolism, and
Anticholinesterase Properties of Acephate and Methamidophos. J. Environ. Sci. Health, B20 (1),
p. 129-147. (1985).
Juarez, L.M., J. Sanchez. 1989. Toxicity of the Organophosphorous Insecticide Methamidophos
(0,S-Dimethyl Phosphoramidothioate) to Larvae of the Freshwater Prawn, Macrobachium
rosenbergii (DeMan) and the Blue Shrimp, Penaens stylirostris Stepson, Bull. Environ.
Contam. Toxicol. (1989) 43:302-309.
Mineau, P. 1991. Cholinesterase-Inhibiting Insecticides: Their Impact on Wildlife and the
Environment
Mullins, J.A., R.F. Carsel, J.E. Car borough, and A.M. Avery. 1993. PRZM-2 User's Manual,
Version 1.0. Environmental Research Laboratory, Office of Research and Development, U.S.
Environmental Protection Agency, Athens, GA.
Neil, C. et al. 1987. Second annual report: Pesticides in ground water. Maine Geological
Survey, Department of Conservation.
Neil, C. et al. 1989. Pilot study: Pesticides in ground water - Final report Maine Geological
Survey, Department of Conservation.
Smith, GJ. 1987. Pesticides Used and Technology in Relation to Wildlife: Organophosphorous
and Carbamate Compounds. U.S.Fish and Wildlfe Service Resource Publication 170. 171 pp.
Rattner, BA, DJ. Hoffman. 1984. Comparative toxicity of acephate in laboratory mice, whitefooted
mice, Mid meadow voles. Arch. Environ. Contam. Toxicol. 13:483-491.
118
-------
Rattaer, B.A., S.D. Michael. 1985. Organophosphorous insecticide induced decrease in plasma
luteinizing hormone concentration in white-footed mice. Toxicology Letters, 24:65-69.
119
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Intentionally Blank Page
120
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Apper. tlis E: Geaeric Bats Call la
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0043 Methamidophos
Chemical # and Name 101201
Methamidophos
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-101201-NNNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
7. Product Specific Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of ComDanv
AA r»u
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0043 Methamidophos
Chemical # and Name 101201
Methamidophos
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-101201-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Applicator Exposure Data Requirements (Conventional
875,1100
875.1300
835.2410
835.4400
835,6100
850.4100
850.4150
875.2400
Chemicall
Dermal exposure-outdoor
Inhalation exposure-outdoor
Environmental Fate Data Requirements (Conventional
(10,11 ,12
,13)
Chemical)
Photodegradation of parent and degradates in soil (6)
Anaerobic aquatic metabolism
Terrestrial field dissipation (7,8)
Nontarqet Plant Protection Data Requirements (Conventional
Chemical)
Terrestrial plant toxicity, Tier 1 (seeding emergence)
Terrestrial plant toxicity, Tier 1 (vegetative vigor)
Post-Application Exposure Data Requirements (Conventional
Dermal exposure
(14,15,16
,17,18)
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
TEP
TEP
TGAI or PAIRA
TGAI
TEP
TGAI
TGAI
TEP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12
12
12
24
24
12
12
24
12. Name of Company
13, Phone Number
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS; Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0043 Methamidophos
Chemical # and Name 101201
Methamidophos
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-101201-NNNNN
4. Guideline
Requirement
Number
5. Study Title
p
R
O
T
O
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
0
L
1
2
3
Product Chemistrv Data Reauirements (Conventional
Chemical)
830.6313
Stability to sunlight, normal and elevated
temperatures, metals, and metal ions
A, B
TGAI
9
830.7050
UV/Visible absorption
A, B
TGAI/PAI
8
830.7200
Melting point/melting range (1 ,2)
A, B
TGAI or PAI
9
830.7370
Dissociation constant in water (3,4)
A, B
TGAI or PAI
9
830.7550
Partition coefficient (n-octanol/water), shake flask (5)
method
Residue Chemistrv Data Reauirements for Food Uses
A, B
TGAI or PAI
9
(Conventional Chemical)
860.1850
Confined accumulation in rotational crops (9)
Terrestrial and Aauatic Nontaraet Oraanisms Data
A, B
PAIRA
24
Reauirements (Conventional Chemical)
850.1300
Daphnid chronic toxicity test
A, B
TGAI
12
850.1350
Mysid chronic toxicity test
A, B
TGAI
12
Initial to indicate certification as to information on this page
(full text of certification is on nane nn«»^
Date
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS; Please typo or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) If necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
167-1-S5
2, Case # and Name
0043 Methamidophos
Chemical # and Name 101201
Methamidophos
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-101201-NNNNN
5. Study Title
Drinking Water Monitoring
(19)
Progress
Reports
6, Use
Pattern
A, B
7. Test
Substance
TEP
8. Time
Frame
(Months)
24
9. Registrant
Response
initial to indicate certification as to Information on this page
' ill text of certification Is on page one).
Date
-------
DRAFT COPY Page 1 of2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: GDCI-101201 -NNNNN
Key: PAIRA = PAI Radio Labeled [PAIRA]; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure
Active Ingredient; TGAI or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
2 Required when the TGAI is solid at room temperature.
3 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
4 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
5 Required if the TGAI or PAI is organic and non-polar.
6 Not required when the chemical is to be applied only by soil injection or is incorporated in the soil.
7 Required for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.
8 Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. The
environmental chemistry methods must include a statement of no data confidentiality claims, i.e., non-CBI. Test standards and procedures for independent laboratory validation are available
as addenda to the guideline for this test requirement.
9 Required when it is reasonably foreseeable that a food or feed crop could be subsequently planted on the site of the pesticide application.
10 Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmocokinetics of the pesticide and/or metabolite/analog
compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.
11 Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
12 Data are required for outdoor occupational site if the product is applied outdoors.
13 Data are required for residential use sites if the product is applied outdoors.
14 Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: GDCI-101201-NNNNN
Key: PAIRA = PAI Radio Labeled [PAIRA]; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure
Active Ingredient; TGAI or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Bridging applicable residue dissipation data to dermal exposure is required.
16 Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog
compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for a back-calculation to the total internal dose.
17 Data are required for residential sites if post-application exposures are likely.
18 Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.
19 Monitoring program of community drinking water systems from surface water sources in areas where methamidophos is used.
-------
Intentionally Blank Page
128
-------
Appendix F: Product Specific Data Call In
129
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0043 Methamidophos
Chemical # and Name 101201
Methamidophos
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-101201-NNNN
4. EPA
Product
Registration
5. 1 wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
7. Product Specific Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Siqnature and Title of Company's Authorized Representative
9. Date
10. Name of ComDanv
-------
United Stales Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMD Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print In Ink. Please read carefully the attached instructions and supply the information requested on this form,
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2, Case # and Name
0043 Methamidophos
EPA Reg, No. NNNNNN-NNNNN
Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-101201 -NNNN
4. Guideline
Requirement
Number
8, Study Title
Progress
Reports
6. Use
Pattern
7, Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.1600
830.1620
830.1650
830.1670
830,1700
830,1750
830.1800
830.6302
830.6303
830.6304
Product Identity and composition (1)
Description of materials used to produce the product (2)
Description of production process (3)
Description of formulation process (4)
Discussion of formation of impurities (5)
Preliminary analysis (6,7,8)
Certified limits (9,10)
Enforcement analytical method (11)
Color (12)
Physical state (13)
Odor (14)
A, B
A, i
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, Imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
11, Date
13. Phone Number
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection
OMB Approval 2070-0107
Agency Washington, D.C. 20460
OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
2. Case # and Name
3.
Date and Type of DCI and Number
SAMPLE COMPANY
0043 Methamidophos
DD-MMM-YYYY
NO STREET ADDRESS
PRODUCT SPECIFIC
NO CITY, XX 00000
EPA Reg. No. NNNNNN-NNNNN
ID# PDCI-101201-NNNN
4. Guideline
Requirement
Number
5. Study Title
P
R
O
T
O
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
0
L
1
2
3
830.6313
Stability to sunlight, normal and elevated (15,16)
temperatures, metals, and metal ions
A, B
TGAI
8
830.6314
Oxidizing or reducing action
(17)
A, B
MP/EP
8
830.6315
Flammability
(18)
A, B
MP/EP
8
830.6316
Explodability
(19)
A, B
MP/EP
8
830.6317
Storage stability of product
(20)
A, B
MP/EP
8
830.6319
Miscibility
(21)
A.B
MP/EP
8
830.6320
Corrosion characteristics
(22)
A, B
MP/EP
8
830.6321
Dielectric breakdown voltage
(23)
A, B
MP/EP
8
830.7000
pH of water solutions or suspensions
(24 ,25)
A, B
TGAI/MP/EP
8
830.7050
UVA/isible absorption
A, B
TGAI/PAI
8
830.7100
Viscosity
(26)
A, B
MP/EP
8
830.7200 .
Melting point/melting range
(27 ,28)
A, B
TGAI
8
Initial to indicate certification as to information on this page
Date
-------
United States Environmental Protection
OMB Approval 2070-0107
Agency Washington, D.C. 20460
OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
2. Case # and Name
3.
Date and Type of DCI and Number
SAMPLE COMPANY
0043 Methamidophos
DD-MMM-YYYY
NO STREET ADDRESS
PRODUCT SPECIFIC
NO CITY, XX 00000
EPA Reg. No. NNNNNN-NNNNN
ID# PDCI-101201-NNNN
4. Guideline
Requirement
Number
5. Study Title
P
R
0
T
0
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
o
L
2
3
830.7220
Boiling point/boiling range
(29 ,30)
A, B
TGAI
8
830.7300
Density/relative density
(31 ,32)
A, B
TGAI/MP/EP
8
830,7370 .
Dissociation constant in water
(33 ,34)
A, B
TGAI or PAI
8
830.7550
Partition coefficient (n-octanol/water), shake flask (35)
method
A, B
TGAI/PAI
8
830.7570
Partition coefficient (n-octanol/water), estimation by (36)
liquid chromatography
A, B
TGAI/PAI
8
830.7840
Water solubility: Column elution method, shake flask (37)
method
A, B
TGAI or PAI
8
830.7860
Water solubility, generator column method (38)
A, B
TGAI or PAI
8
830.7950
Vapor pressure
(39 ,40)
A, B
TGAI or PAI
8
Toxicoloav Data Reauirements (Conventional Chemical)
870.1100
Acute Oral Toxicity
(41 ,42)
A, B
TGAI/MP/EP
8
870,1200
Acute dermal toxicity
(43 ,44 ,45)
A, B
TGAI/MP/EP
8
870.1300
Acute inhalation toxicity
(46)
A, B
TGAI/MP/EP
8
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
DRAFT COPY
Page 4 ot 4
United States Environmental Protection
Agency Washington, D.C. 20460
OMB Approval 2070-0107
OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
2. Case # and Name
3.
Date and Type of DCI and Number
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
0043 Methamidophos
EPA Reg. No. NNNNNN-NNNNN
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-101201-NNNN
4. Guideline
Requirement
Number
5. Study Title
P
R
O
T
O
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
0
L
1
2
3
870.2400
Acute eye irritation
(47)
A, B
TGAI/MP/EP
8
870.2500
Acute dermal irritation
(48 ,49)
A, B
TGAI/MP/EP
8
870.2600
Skin sensitization
(50 ,51)
A, B
TGAI/MP/EP
8
Initial to indicate certification as to information on this page
tfnil tov* nf nariifinatinn ic nn nana r\ne*\
Date
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: PDCI-101201-NNNN .
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
3 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
4 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
5 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
6 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
7 Required for TGAIs and products produced by an integrated system.
8 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
10 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
11 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
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DRAFT COPY Page2of4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: PDCI-101201-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
17 Required if the product contains an oxidizing or reducing agent
18 Required when the product contains combustible liquids.
19 Required when the product is potentially explosive.
20 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
21 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
22 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
23 Required if the end-use product is a liquid and is to be used around electrical equipment.
24 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
25 Required if the product is dispersible with water.
26 Required if the product is a liquid.
27 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
28 Required when the TGAI is solid at room temperature.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: PDCI-101201 -NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient tTGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
35 Required if the TGAI or PAI is organic and non-polar.
36 Required if the TGAI or PAI is organic and non-polar.
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
40 Not required for salts.
41 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
42 Not required if test material is a gas or a highly volatile liquid.
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DRAFT COPY Page4of4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0043 Methamidophos
PCI Number: PDCI-101201-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient fTGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes: [the following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
43 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
44 Not required if test material is a gas or a highly volatile liquid.
45 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
46 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
47 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
48 Not required if test material is a gas or a highly volatile liquid.
49 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
50 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
51 Required if repeated dermal exposure is likely to occur under conditions of use.
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Appendix G: EPA'S Batching of Metfaamfdophos Products for Meeting Acute Toxicity Data
Requirements for Reregistratton
in an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregisteatkm of products containing Methamidoph cs as the primary active
ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiaMe concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.)* Note the Agency is not describing batched products as "substantially similar" since some
products with in a batch may not be considered chemically similar or have identical use patterns.
Using available infoimatiorL, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity date, for an individual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
batteiy of six acute toxicological studies to represent all the products witMn feat batch. It is fee
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within in a batch, or to generate all tie required acute toxicological
studies for each of their own products. If the registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If the registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base, is complete and
valid by tc-days standards (see acceptance criteria attached), the formulation tested is considered by
EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data
is referenced, the registrants must clearly identify the test material by EPA Registration Number. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the directions
given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains
two response forms which are to be completed and submitted to the Agency within 90 days of receipt.
The first form, "Date. Call-in Response," asks whether the registrant will meet the data requirements for
each product. The second form, "Requirements Status and Registrant's Response," lists the product
specific data required for each product, including the standard six acute toxicity teste. A registrant who
wishes to participate in a batch must decide whether he/she will provide the data or depend on someone
else to do so. If the registrant supplies the data to support a batch of products, he/she must select the one
of the following options: Developing data (Option 1), Submitting an existing Study (Option 4), Upgrading
an existing Study (Option 5), or Citing an Existing Study - (Option). If a registrant depends on another's
data, he/she must choose among: Cost sharing (Option 2), Offers to Cost Share (Option 3) or Citing an
Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options
1,4,5 or 6. However, a registrant should know that choosing not to participate in a batch does not
preclude other registrants in the batch from citing his/her st udies and offering to cost share (Option 3)
139
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those studies.
Five products were found which contain Methamidophos as the active ingredient. These products
have been placed into one batch and a No Batch in accordance with the active and inert ingredients
mid type of formulation.
Batch 1
EPA Reg. No.
Percent active ingredient
Formulation Type
3125-280
40.58
Solid
59639-56
40.58
Solid
No Batch
EPA Reg. No.
Percent active ingredient
Formulation Type
3125-341
74.6
Solid
3125-348
60.0
Liquid
59639-68
72.0
Solid
140
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Appends H-. List of Registrants Sent DCIs
141
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United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0043,Methamldophos
Co. Nr.
Company Name Agent For Address
City & State
Zip
264
BAYER CROPSCIENCE LP 2 T.W. ALEXANDER DRIVE
RESEARCH
NC 27709
TRIANGLE PARK
3125
BAYER CORP PO Box 4913 8400 HAWTHORN RD
KANSAS CITY
MO 641200013
59639
VALENT U S A. CORPORATION PO Box 8025 1600 RIVIERA AVENUE, SUITE 200
WALNUT CREEK
CA 94596
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Appendix I: List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
htto://www.eoa.gov/ onnrdQ01 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filed out on your
computer then printed.)
2. The completed fom^s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the feraes, along with any additional documents necessaiy to comply wife EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fex or e-mail any form containing 'Confidential Business Information* or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by
e-mail at wilbamjsjffieole@epa.gov. "
Hie following Agency Pesticide Registration Forms are currently available via fee internet
at fee following locations:
8570-
1
Application for Pesticide
Registration/Amendment
httD://www.eoa.eov/onDrdOO 1 /forms/8570-1 .r?df
8570-
4
Confidential Statement of Formula
httD://www.eDa.2ov/oDnrd001/&rms/8570-4.ndf
8570- '
5
Notice of Supplemental Registration of
Distributi on of a Registered Pesticide
Product
htto://www.eDa.2ov/oDDrd001/forms/8570-5.ndf
8570-
17
Application for an Experimental Use
Permit
htto://www.eDa.eov/oDDrdOO 1/forms/8570-17.ndf
8570-
25
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
htta://www.em.eov/ooordG01 /forms/8570-25 .rsdf
8570- :
27
Fomulator's Exemption Statement
httD://www.etm.eov/oi5Drd00I/forms/8570-27.ndf
143
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8570-
28
Certification of Compliance with Data
Gap Procedures
http://www.epa.gov/opprdGGI/ferms/8570-28.pdf
8570-
30
Pesticide Registration Maintenance Fee
Filing.
http://www.epa.pov/opprdOO 1 /forms/8570-3 f).pdf
8570-
32
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
httn://www.eoa.eov/onnrd001/forms/8570-32.ndf
8570-
34
Certification with Respect to Citations
of Data (PR Notice 98-5)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5,pdf
8570-
35
Data Matrix (PR Notice 98-5)
http://www.eDa.eov/opppmsdl/PR Notices/pr98-
5.pdf
8570-
36
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
httn://www.eDa.BOV./oDDDmsd 1/PR Notices/nr98-
1 'pdf
8570-
37
Self-Certification Statement for the
Physical/Chemical Properties (PR
Notice 98-1)
http://www.epa.gov/opppmsdI/PR Notices/pr98-
Pesticide Registration Kit www.cpa.gov/pesticides/Vegistratiankit/
Dear Registrant:
Fa* your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1, The Federal Insecticide, Fungicide, and Rodentieide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
£ 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
144
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PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require
the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment •
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are In PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
33. Biopesticides and Pollution Prevention Division (BPPD) Contacts
C. Antimicrobials Division Qrpnizational Structure/Contact List
d. ¦ 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
£ ' 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Date (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources of
information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United States",
PB92-221811, available through the National Technical Information Service (NTIS) at fee
following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone numbs- for NTIS is (703) 605-6000.
3. Hie National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems, This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their website.
145
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4. The National Pesticide Information Center (NPIC) can provide information on active ingredients,
uses, toxicology, and chemistry of pesticides. You can contact NPIC by telephone at (800)
858-7378 or through their website: http://npic.orst.edu..
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be complete! by OPP:
Date of receipt;
• EPA identifying number; aid
• Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the
EPA identifying file symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application for registration,
experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind" codes
used when a sample was submitted for testing by commercial or academic facilities). Please
provide a chemical abstract system (CAS) number if one has been assigned.
Documents Associated with this BED
The following documents are part of the Administrative Record for this RED document and may be
included in the EPA's Office of Pesticide Programs Public Docket.' Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science Chapters, which
include the complete risk assessments and supporting documents.
2. Detailed Label Usage Information System (LUIS) Report.
146
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REPORT DOCUMENTATION PAGE
Form Approved
OMB No. 0704-0188
"he public reporting burden for this collection of information is estimated to average t hour per response, including the time for reviewing instructions, searching existing data sources,
_ethering ard maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports
(07G4-G1S8), 17.15 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be
subject to any penally for failing to comply with a collection of information if it does not dispiay a currently valid OMB control number.
PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS.
1. REPORT DATE (DD-MM-YYYYS 2. REPORT TYPE
3. DATES COVERED iFrom - To)
4. TITLE AND SUBTITLE
INTERIM REREGISTRATION ELIGIB1LTY DECISION {!RED): METHAMIDOPHOS
5a. CONTRACT NUMBER
Sb. GRANT NUMBER
5c. PROGRAM ELEMENT NUMBER
6. AUTHOR®
Ed. PROJECT NUMBER
5e. TASK NUMBER
51 WORK UNIT NUMBER
7. PERFORMING ORGANIZATION NAMESSi AND ADDEESSfES!
8. PERFORMING ORGANIZATION
REPORT NUMBER
9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES)
OPPTS/OPP/SRRD (7508C)
1200 Pennsylvania Ave NW
Washington, DC 20480
10. SPONSOR/MONITOR'S ACRONYMS)
11. SPONSOR/MONITOR'S REPORT
NUMBERfS}
12. DiSTRlBUTIOM/AVAILAEILITY STATEMENT
13. SUPPLEMENTARY NOTES
14, ABSTRACT
15, SUBJECT TERMS
1G. SECURITY CLASSIFICATION OF:
17. LIMITATION OF
ABSTRACT
18. NUMBER ]19a, NAME OF RESPONSIBLE PERSON
OF
I
a. REPORT | b. ABSTRACT
c. THIS PAGE
J 19b. TELEPHONE NUIVTBER (Include srna code)
Standard Form 298 (Rev. 8/98}
Prescribed by ANSI Stit. Z3S.1S
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