US Environmental Protection Agency
'•£ Office of Pesticide Programs
IU
0
* Reregistration Eligibility Decision
for Coumaphos
When EPA concluded the organophosphate (OP) cumulative risk assessment in July 2006, all
tolerance reassessment and reregi strati on eligibility decisions for individual OP pesticides were
considered complete. OP Interim Reregistration Eligibility Decisions (IREDs), therefore, are
considered completed REDs. OP tolerance reassessment decisions (TREDs) also are considered
completed.
Combined PDF document consists of the following:
• Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and
Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the
Organophosphate Pesticides (July 31, 2006)
• Coumaphos TRED
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\
uj
UNITED ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C.,
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
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(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
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Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
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United States Prevention, Pesticides EPA738-R-00-010
Environmental Protection And Toxic Substances September 2000
Agency (7508C)
Reregistration Eligibility
Decision Addendum and
FQPA Tolerance
Reassessment Progress
Report
Coumaphos
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, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency has completed its review of the
available data and public comments related to the revised human health risk assessment for the
organophosphate (OP) pesticide coumaphos. Due to the relatively low volume use of coumaphos
compared to other organophosphates, the Agency determined that a technical briefing was not
necessary for this chemical. During Phase 5 of the OP pilot public participation process, all interested
parties were invited to participate and provide comments and suggestions on ways the Agency might
mitigate the estimated risks presented in the revised risk assessment. This public participation and
comment period commenced on April 26, 2000, and closed on June 26, 2000. The attached
document entitled, "Reregistration Eligibility Decision Addendum and FQPA Tolerance Reassessment
Progress Report for Coumaphos," which was approved on September 27, 2000, summarizes the
Agency's assessment of the dietary and occupational risks from coumaphos. Based on its review and
public comments, EPA has identified risk mitigation measures believed necessary to address the human
health risks associated with the current use of coumaphos. These risk mitigation measures can be found
in the attached document.
The major means by which the Agency reassesses tolerances is through its reregistration
process. Each pesticide registered prior to 1984 is subject to a comprehensive evaluation of its effects
on human health and the environment. Such an evaluation includes a determination of whether the
tolerances are safe. Since coumaphos was first registered in 1958, it is subject to reregistration. The
Agency issued a Reregistration Eligibility Decision (RED) document for coumaphos in 1996, prior to
the passage of the Food Quality Protection Act of 1996 (FQPA). However, coumaphos tolerances
are subject to reassessment in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA)
as amended by FQPA. This Act requires EPA to re-evaluate existing tolerances to ensure that children
and other sensitive populations are protected from pesticide risk. The tolerance reassessment decision
for coumaphos will be finalized once the cumulative assessment for all of the organophosphate
pesticides is complete.
The Coumaphos RED of 1996 established that the U.S. Department of Agriculture-Animal and
Plant Health Inspection Service (USD A-APHIS) uses of coumaphos were eligible for reregistration,
primarily due to the important use of this insecticide in the USD A-APHIS Cattle Fever Tick
Eradication Program and the Program's significant benefit to the U.S. economy. In addition, the
USD A-APHIS has an established cholinesterase monitoring program, in which staff are tested
periodically and prevented from handling coumaphos if cholinesterase levels reach a level of concern.
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In the 1996 RED, the Agency deferred making a regulatory decision on all uses of coumaphos other
than USD A-APHIS uses, contingent on the submission and review of coumaphos-specific handler
exposure studies. However, more recently, based on the small volume, declining trend in the use of
coumaphos as livestock and swine bedding treatments, and other information, the Agency determined
that the chemical-specific handler exposure studies previously required in the Data Call-in issued along
with the 1996 RED were no longer needed.
The attached document, in addition to reassessing coumaphos tolerances, follows-up on the 1996
RED by issuing the reregistration eligibility decision for the non-USDA uses of coumaphos. In order to
make this decision, the Agency reviewed and considered surrogate handler exposure data submitted by
the registrant and conducted an occupational risk assessment incorporating surrogate exposure data
available. The Agency has not conducted a new risk assessment for the effects of coumaphos on non-
target species (e.g., fish, birds, mammals), because we have no reason to believe our conclusions
would change since the 1996 RED.
A Notice of Availability for this Reregistration Eligibility Decision Addendum and FQPA
Tolerance Reassessment Progress Report for coumaphos is being published in the "Federal Register."
To obtain a copy of this document, please contact the OPP Public Regulatory Docket (7502C), US
EPA, Ariel Rios Building, 1200 Pennsylvania Avenue NW, Washington, DC 20460, telephone (703)
305-5805. Electronic copies of the RED Addendum and all supporting documents are available on the
Internet. See "http://www.epa.gov/pesticides/op."
The RED Addendum is based on the updated technical information found in the coumaphos
public docket. The docket not only includes background information and comments on the Agency's
preliminary risk assessment, it also includes the Agency's revised risk assessment for coumaphos
(revised as of January 13, 2000), a document summarizing the Agency's Response to Comments, and
recent revisions/addenda to the dietary (food), drinking water and occupational risk assessments. The
Response to Comments document addresses corrections to the preliminary risk assessment submitted
by the chemical registrant, as well as responds to comments submitted by the general public and
stakeholders during the comment period on the risk assessment. The docket also includes comments
on the revised risk assessment, and risk mitigation proposals submitted during Phase 5. A proposal
was submitted for coumaphos by the technical registrant, Bayer Corporation. Comments and
suggestions on risk mitigation were also submitted by Bayer Corporation.
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 the organophosphate pesticides. As part of the Agency's effort to involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets on the organophosphate pesticides and to engage the
public in the reregistration and tolerance reassessment processes for these chemicals. This open
process follows the guidance developed by the Tolerance Reassessment Advisory Committee (TRAC),
a large multi-stakeholder advisory body that advised the Agency on implementing the new provisions of
the FQPA. The reregistration and tolerance reassessment reviews for the organophosphate pesticides
are following this new process.
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Please note that the coumaphos risk assessment and the attached RED Addendum concern only
this particular organophosphate. This document presents the Agency's reregistration decision, except
for the decision on tolerance reassessment. Because the FQPA directs the Agency to consider
available information on the basis of cumulative risk from substances sharing a common mechanism of
toxicity, such as the toxicity expressed by the organophosphates through a common biochemical
interaction with cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire
organophosphate class of chemicals after completing the risk assessments 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 necessary elements
of any cumulative assessment. The Agency has decided to move forward with individual assessments
and to identify mitigation measures necessary to address the human health risk estimates associated with
the current uses of coumaphos. The Agency will issue the final tolerance reassessment decision for
coumaphos once the cumulative assessment for all of the organophophates is complete.
In this RED Addendum, the Agency has determined that coumaphos will be eligible for
reregistration 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 coumaphos may pose unreasonable adverse effects to human health, and
that such effects can be mitigated with the risk mitigation measures identified in this RED. Accordingly,
the Agency recommends that registrants implement these risk mitigation measures immediately. Section
IV of this RED describes labeling amendments for the technical, manufacturing-use and end-use
products necessary to implement these mitigation measures. Instructions for registrants on submitting
revised labeling and the time frame established to do so can be found in Section V of this document.
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 coumaphos. Where the Agency
has identified any unreasonable adverse effect to human health, 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 proposed label changes, please contact the
Chemical Review Manager, Monica Alvarez, at (703) 308-8026. For questions about product
reregistration, please contact Moanna Appleyard at (703) 308-8175.
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Reregistration Eligibility Decision Addendum and FQPA
Tolerance Reassessment Progress Report
for
Coumaphos
Case No. 0018
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TABLE OF CONTENTS
COUMAPHOS TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS iv
EXECUTIVE SUMMARY 1
I. INTRODUCTION 4
II. CHEMICAL OVERVIEW 6
A. Regulatory History 6
B. Chemical Identification 6
C. Use Profile 7
D. Estimated Usage of Pesticide 8
III. SUMMARY OF COUMAPHOS RISK ASSESSMENT 9
A. Human Health Risk Assessment 9
1. Dietary Risk from Food 10
a. Toxicity 10
b. FQPA Safety Factor 10
c. Population Adjusted Dose (PAD) 10
d. Exposure Assumptions 11
e. Food Risk Characterization 11
2. Dietary Risk from Drinking Water 12
a. Surface Water 13
b. Ground Water 13
c. Drinking Water Levels of Comparison (DWLOCs) 13
3. Aggregate Risk 14
4. Occupational Risk 15
a. Toxicity 15
b. Exposure 16
c. Occupational Handler Risk Summary 18
1) Occupational Handler Risk 19
2) Post-Application Occupational Risk 24
B. Environmental Risk Assessment 24
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 24
A. Determination of Reregistration Eligibility 24
B. Summary of Phase 5 Comments and Responses 26
C. Regulatory Position 27
1. FQPA Assessment 27
a. "Risk Cup" Determination 27
b. Tolerance Summary 28
2. Endocrine Disrupter Effects 29
D. Regulatory Rationale 29
1. Human Health Risk Mitigation 30
a. Dietary Risk Mitigation 30
1) Acute Dietary (Food) 30
2) Chronic Dietary (Food) 30
3) Drinking Water 30
b. Occupational Risk Mitigation 31
E. Label Modifications 32
F. Other Labeling Modifications 32
1. Endangered Species Statement 32
V. WHAT REGISTRANTS NEED TO DO 33
A. Manufacturing-Use Products 33
1. Additional Generic Data Requirements 33
2. Labeling for Manufacturing-Use Products 34
B. End-Use Products 34
1. Additional Generic Data Requirements 34
2. Labeling for End-Use Products 34
C. Existing Stocks 34
D. Labeling Changes Summary Table 36
VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM 44
VII. APPENDICES 45
A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION 47
B. DATA SUPPORTING GUIDELINE REQUIREMENTS FOR THE
REREGISTRATION OF COUMAPHOS 51
C. LIST OF AVAILABLE RELATED DOCUMENTS 57
D. CITATIONS SUPPORTING THE REREGISTRATION ELIGIBILITY
DECISION ADDENDUM AND FQPA TOLERANCE
REASSESSMENT PROGRESS REPORT (BIBLIOGRAPHY) 59
E. LIST OF REGISTRANTS 69
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COUMAPHOS TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Christina Jarvis
Sherrie Kinard
Alan Nielsen
Renee Sandvig
Environmental Fate Risk Assessment
Reregistration Branch
Reregistration Branch
Reregistration Branch
Reregistration Branch
Kevin Costello
James Hetrick
Environmental Risk Branch I
Environmental Risk Branch I
Use and Usage Analysis
Art Grube
Stephen Smearman
Registration Support
Economic Analysis Branch
Economic Analysis Branch
Linda DeLuise
Insecticide Branch
Risk Management
Monica Alvarez
Daniel Helfgott
Special Review Branch
Special Review Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
ARI Aggregate Risk Index
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USD A Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific
(i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects
are not anticipated to occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities
and other organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
L Liter
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square
meter.
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM7
EXAMS Tier H Surface Water Computer Model
Q !* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
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GLOSSARY OF TERMS AND ABBREVIATIONS
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard
conditions.
TRR Total Radioactive Residue
UF Uncertainty Factor
//g/g Micrograms Per Gram
//g/L Micrograms Per Liter
USD A United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
VI
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EXECUTIVE SUMMARY
Coumaphos is an organophosphate insecticide/acaricide used on livestock and swine bedding,
first registered in 1958 for the control of flies, mites, and ticks. Most recently, the Agency granted
emergency FIFRA exemptions to several States for the use of coumaphos in honey bee hives to control
varroa mites and small hive beetles. The Agency also established time-limited tolerances for
coumaphos residues in honey and beeswax associated with these emergency exemptions. Coumaphos
is a small volume use active ingredient, and its use has declined by nearly 50% since 1990.
In the Coumaphos Reregistration Eligibility Decision (RED) document of August 1, 1996, the
Agency determined that only U.S. Department of Agriculture-Animal and Plant Health Inspection
Service (USD A-APHIS) uses of coumaphos were eligible for reregistration, primarily due to the
important use of this insecticide in the USD A-APHIS Cattle Fever Tick Eradication Program and the
Program's significant benefit to the U.S. economy. In addition, the USD A-APHIS has an established
cholinesterase monitoring program, in which staff are tested periodically and prevented from handling
coumaphos if cholinesterase levels reach a level of concern. In 1996, prior to the passage of the Food
Quality Protection Act of 1996 (FQPA), the Agency deferred a regulatory decision on all uses of
coumaphos other than the USDA-APHIS dip vat use, contingent on the submission and review of
coumaphos-specific handler exposure studies. Non-USDA uses are spray and back rubber/oiler uses
of the liquid formulations and shaker can, mechanical duster and dust bag uses of the dust formulations.
This document follows up on the Coumaphos RED issued in 1996. It establishes the Agency's
reregistration eligibility and risk management decision for coumaphos uses other than USDA-APHIS
uses, for which no reregistration eligibility decision was made in the 1996 Coumaphos RED and
provides information on the reassessment of coumaphos tolerances in accordance with the Federal
Food, Drug, and Cosmetic Act (FFDCA) as amended by FQPA. This Act requires EPA to re-
evaluate existing tolerances to ensure that children and other sensitive populations are protected from
pesticide risk, progress of the FQPA tolerance reassessment for coumaphos.
In order to make the reregistration eligibility decision, the Agency reviewed and considered
surrogate handler exposure data submitted by the registrant and conducted an occupational risk
assessment incorporating surrogate exposure data available. The Agency has not conducted a new risk
assessment for the effects of coumaphos on non-target species (e.g., fish, birds, mammals), because we
have no reason to believe our conclusions would change since that time. Because EPA issued the
Coumaphos RED in 1996, before the passage of FQPA; for simplicity, we will refer to this document
as a RED Addendum.
EPA has completed its review of public comments on the revised coumaphos dietary and
occupational risk assessments and is issuing its risk management decisions for this chemical. The
decisions outlined in this document do not include the final tolerance reassessment decision for
coumaphos; however, some tolerance actions will be undertaken prior to the completion of the final
1
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tolerance reassessment. Six tolerances should be proposed for revocation because the technical
registrant, Bayer Corporation, no longer supports the use of coumaphos on sheep and goats and has
requested voluntary cancellation of these uses. The final tolerance reassessment decision for this
chemical will be issued once the cumulative assessment for all of the organophosphates is complete.
The Agency may need to pursue further risk management measures for coumaphos once the cumulative
assessment is finalized.
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 coumaphos. After considering revised risks, risk
mitigation measures proposed by Bayer Corporation, and comments from other interested parties,
including USD A-APHIS, EPA developed its risk management decision for uses of coumaphos that
pose risks of concern. This decision is discussed fully in this document.
Overall Risk Summary
EPA's human health risk assessment for coumaphos indicates some risk concerns. Food risks,
both acute and chronic, do not exceed the Agency's level of concern. Similarly, acute and chronic
exposures to coumaphos in drinking water, based on surface and groundwater screening modeling, are
not of concern. There are, however, risk concerns for workers who mix, load, and apply coumaphos
to livestock and swine bedding.
To mitigate risks of concern posed by the uses of coumaphos, EPA considered the mitigation
proposal submitted by the technical registrant, as well as comments from other interested parties, and
has decided on a number of label amendments to address worker risk concerns. Results of the risk
assessments and necessary label amendments to mitigate those risks are presented in this document.
Dietary Risk
Acute and chronic dietary risk assessments for food and drinking water indicate risks do not
exceed the Agency's level of concern; therefore, no mitigation is warranted at this time for any acute or
chronic dietary exposure to coumaphos.
Occupational Risk
Occupational exposure to coumaphos is of concern, and the Agency identified a number of
mitigation measures that need to be implemented at this time. Several applicator risk scenarios
currently exceed the Agency's level of concern [i.e., Margins of Exposure (MOEs) are less than 100 or
Aggregate Risk Indexes (ARIs) are less than 1] at baseline. EPA believes these risks can be mitigated
to an acceptable level with the following label changes: restriction of one formulation to only USD A-
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APHIS use, deletion of a method of application, limitation on the number of animals and area of animal
bedding to be treated, and addition of personal protective equipment. Therefore, with the addition of
the label restrictions and amendments detailed in this document, the Agency has determined that, until
the outcome of the cumulative risk assessment for all of the organophosphates has been decided, all
currently registered uses of coumaphos may continue, except for the uses on sheep and goats for which
the technical registrant has requested voluntary cancellation. In addition, the Agency has determined
that the non-USD A uses of coumaphos, for which no reregistration decision was made in the 1996
RED document, are eligible for reregistration when the label changes outlined in Section IV of this
document are implemented by the registrant.
The Agency is issuing this RED Addendum for coumaphos, as announced in a Notice of
Availability published in the "Federal Register." This document includes guidance and time frames for
complying with any necessary label changes for products containing coumaphos. 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 coumaphos have already been subject to numerous public comment
periods, and a further comment period for coumaphos was deemed unnecessary. Therefore, there is
no comment period for this document. With regard to complying with the risk reduction measures
outlined in this document, the Agency has shortened this time period so that the risks identified herein
are mitigated as quickly as possible. Neither the tolerance reassessment nor the reregistration eligibility
decision for coumaphos can be considered final, however, until the cumulative risk assessment for all
organophosphate pesticides is complete. The cumulative assessment may result in further risk mitigation
measures for coumaphos.
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
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, which
was August 3, 1996. FQPA also amends the 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. Coumaphos 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.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues
for which policies need to be created. These issues were refined and developed through collaboration
between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was
composed of representatives from industry, environmental groups, and other interested parties. The
TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:
Applying the FQPA 10-Fold Safety Factor
• Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
• How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
• Refining Dietary (Food) Exposure Estimates
• Refining Dietary (Drinking Water) Exposure Estimates
• Assessing Residential Exposure
• Aggregating Exposure from all Non-Occupational Sources
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• How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with
a Common Mechanism of Toxicity
• Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and in a
different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued on
September 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 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 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 required
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 document are consistent with the Worker Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for
public comment on science policy issues for the organophosphate pesticides and the worker risk
management PR notice. Section n provides a profile of the use and usage of the chemical. Section m
gives an overview of the revised human health risk assessment resulting from public comments and
other information. Section IV presents the Agency's reregistration eligibility and risk management
decision. Section V summarizes labeling changes necessary based on the risk mitigation measures
outlined in Section IV. Section VI provides information on how to access related documents. Finally,
the Appendices list the use patterns, data supporting guideline requirements and technical supporting
documents, and provide the bibliography, among other information. The revised risk assessments and
related addenda are not included in this document, but are available on the Agency's web page
"http://www.epa.gov/pesticides/op," and in the Public Docket.
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II.
CHEMICAL OVERVIEW
A. Regulatory History
Coumaphos technical was first registered in the United States in 1958 for use as an insecticide.
The first end-use product, a dust formulation, was registered the following year for the control of insects
on cattle. Coumaphos is currently registered for the control of insects, mites, and ticks on livestock and
swine bedding. Since 1999, the Agency has exempted several State agencies from the provisions of
FIFRA due to emergency conditions that required the use of coumaphos in bee hives to control varroa
mites and small hive beetles. The Agency also established time-limited tolerances for combined
residues of coumaphos and its oxygen analog, coumaphoxon, in honey and beeswax associated with
these emergency exemptions.
The Coumaphos RED, along with a DCI requiring coumaphos-specific worker exposure and
environmental fate studies, was issued in August 1996, prior to the passage of FQPA. In the 1996
RED, the Agency declared the USDA-APFflS dip vat use of coumaphos eligible for reregistration and
deferred making a regulatory determination on the non-USD A uses, pending submission of the worker
exposure data. This RED Addendum reflects a reassessment of all data submitted in response to the
1996 DCI and other available data, provides an update on FQPA tolerance reassessment progress and
announces the reregistration eligibility and risk management decision for the non-USDA uses of
coumaphos.
B.
Chemical Identification
Coumaphos:
H5C,O
OC2H5
CH
! Common Name:
! Chemical Name:
! Chemical family:
! Case number:
Coumaphos
0,0-diethylO-(3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl) phosphorothioate
Organophosphate
0018
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! CAS registry number: 56-72-4
! OPP chemical code: 036501
! Empirical formula: C14H16C1O5PS
! Molecular weight: 3628
! Vapor Pressure: lxlO"7mmHg
! Trade and other names: Asuntol, Bay 21/199, Baymix, Co-Ral, ENT-17957,
Muscatox, Resitox
! Basic manufacturer: Bayer Corporation (technical registrant)
Technical coumaphos is a tan solid with a purity of 96% and a melting point of 90-95 ° C. At
20°C, coumaphos is soluble in acetone (23.82 g/100 ml) and diethyl phthalate (21.50 g/100 ml); much
less soluble in denatured alcohol and xylene (0.9 g/100 ml in each); only slightly soluble in octanol (0.13
g/100 ml), hexane (0.07 g/100 ml), and mineral spirits (0.09g/100 ml); and insoluble in water (0.002
g/100 ml). Coumaphos is stable under normal conditions, but hydrolyzes slowly under alkaline
conditions.
C. Use Profile
The following information is based on the currently registered uses of coumaphos:
Type of Pesticide: Insecticide/Acaricide
Summary of Use Sites:
All registered uses are classified as indoor food uses.
Food: Coumaphos is used as a direct animal treatment on beef and dairy cattle, horses,
goats, sheep and swine. Predominant use is on beef cattle.
Residential: None
Public Health: None
Other Nonfood: Swine bedding
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Target Pests: Flies (face fly, horn fly), ticks, lice, mites (scabies mite) and screw
worms.
Formulation Types Registered Technical Grade Active Ingredient (96% pure),
manufacturing product (25% ai dust), end-use products (1% ai dust, 11.6% ai and
6.15% ai emulsifiable concentrates, and 42% ai flowable concentrate).
Method and Rates of Application:
Equipment - Dip vats, low and high-pressure hand wands, back rubber/oiler,
mechanical dusters, dust bags and shaker cans.
Method and Rate - Applied directly to livestock. Depending on animals treated and
formulation type, the maximum label application rates range from 0.005 to 0.025 Ibs
ai/gallon for spray or dip, 0.076 Ibs ai/gallon of oil for back rubbers, 0.000625 to
0.013 Ibs ai/animal for dust, and 0.042 Ibs ai/1,000 sq. ft. of swine bedding.
Timing - Used primarily during early spring to late summer or during the fly season.
Multiple applications to livestock and livestock areas are allowed.
Use Classification: Two liquid products, the 11.6% emulsifiable concentrate and the
42% flowable are classified as Restricted Use Pesticides (RUPs); all other products
have general classification.
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of
coumaphos, based on pesticide usage information for 1990-1999 available to the Agency. A full listing
of all uses of coumaphos, with the corresponding use and usage data for each site (cattle or other
livestock), has been completed and is included in the "Quantitative Usage Analysis for Coumaphos,"
dated August 15, 2000, which is available in the Public Docket. The data, reported on an aggregate
and site basis, reflect annual fluctuations in use patterns as well as the variability in using data from
various information sources. Approximately 71,000 Ibs a.i. of coumaphos is used annually in the
United States, according to Agency estimates.
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Table 1. Coumaphos Estimated Usage for Representative Sites
Site
Cattle
Other Live stock
Lbs. Active Ingredient Applied (Likely Average1)
59,000
12,000
Percent Livestock Treated (Likely
Average)
5.1%
1.3%
Likely averages are the EPA's estimates of what the average uses are likely to be.
Sources: U.S. Census of Agriculture; State Usage Surveys from TX, KS, NY, WY, and NV; State use recommendations; USDA,
NASS, 2000 and EPA data. Refer to the "Quantitative Usage Analysis for Coumaphos," dated August 15, 2000, prepared by
OPP Biological and Economic Analysis Division.
III. SUMMARY OF COUMAPHOS RISK ASSESSMENT
The following is a summary of EPA's revised human health risk findings and conclusions for the
organophosphate pesticide coumaphos, as fully presented in the document, "Revised Dietary and
Occupational Risk Assessment Update for the Coumaphos RED Published August, 1996," dated
January 13, 2000 and more recent revisions to the dietary (food), drinking water and occupational risk
assessments. The purpose of this summary is to assist the reader by identifying the key features and
findings of this risk assessment, and to better understand the conclusions reached in the assessment.
The risk assessments presented here form the basis of the Agency's risk management decision
for coumaphos only; the Agency must complete a cumulative assessment of the risks of all the
organophosphate pesticides before any final decisions can be made.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for coumaphos on September 2, 1999 (Phase 3 of
the TRAC process). In response to public comments and a dietary risk assessment submitted by the
technical registrant during Phase 3, the risk assessments were updated and refined. Major revisions to
the human health risk assessment are listed below:
Development of refined Tier 3 acute and chronic dietary risk assessments;
• Incorporation of refined percent livestock treated information for beef cattle, dairy
cattle and swine commodities and monitoring data for the U.S. Department of
Agriculture (USDA) Pesticide Data Program (PDF) for milk;
• Deletion of spray foam (canceled effective July 29, 1999) and wettable powder
formulations (canceled effective January 31, 2000) from the occupational exposure and
risk assessment.
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In addition to the changes made during Phase 4, the Agency recently revised the dietary (food)
risk assessment to correct an error in the residue files and revised the drinking water assessment to
include less conservative K^ and water solubility assumptions for the oxygen analog, coumaphoxon.
The Agency also developed an addendum to the revised occupational risk assessment, which provides
occupational risk estimates for different handler exposure scenarios considering current labeled
personal protective equipment. These documents are available in the OPP Public Docket for
coumaphos.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is essentially complete, and that it supports a reregistration eligibility determination for all
currently registered uses. Further details on the toxicity of coumaphos can be found in the January 13,
2000 human health risk assessment. A brief overview of the studies used for the dietary risk
assessment is outlined in Table 2 in this document.
b. FQPA Safety Factor
The FQPA Safety Factor was reduced to IX. The toxicity database includes an acceptable
two-generation reproduction study in rats, acceptable prenatal developmental toxicity studies in rats
and rabbits, and acceptable acute and subchronic neurotoxicity studies in rats. These studies show no
increased sensitivity to fetuses as compared to maternal animals following acute in utero exposure in
the developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in a
multi-generation reproduction study in rats. There was no evidence of abnormalities in the development
of the fetal nervous system in the pre/postnatal studies. Adequate actual data, surrogate data, and/or
modeling outputs are available to satisfactorily assess dietary exposure and to provide a screening level
drinking water exposure assessment. The assumptions and models used in the assessments do not
underestimate the potential risk for infants and children. Therefore, the 10X factor required by FQPA
was reduced to IX.
c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical, and reflects the Reference
Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e.,
RfD/FQPA safety factor). In the case of coumaphos, the FQPA safety factor is 1; therefore, the acute
or chronic RfD is the same as the acute or chronic PAD, respectively. A risk estimate that is less than
100% of the acute or chronic PAD does not exceed the Agency's risk concern.
10
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Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary
Risk Assessment of Coumaphos
Assessment
Acute Dietary
Chronic Dietary
Dose
2.0 mg/kg/day
(LOAEL)
0.025 mg/kg/day
(NOAEL)
Endpoint
Plasma ChE
inhibition in
females and RBC
ChE inhibition in
both male and
female rats
Plasma and RBC
ChE inhibition in
both male and
female dogs seen
at the LOAEL of
0.77 mg/kg/day
Study
Acute Oral
Neurotoxicity in
Rats (MRID
44544801)
Chronic Toxicity in
Dog (MRID
43055301)
UF
300a
100
FQPA
Safety
Factor
IX
IX
PAD
0.007
mg/kg/day
0.0003
mg/kg/day
Uncertainty factor is 300 due to an additional 3X for the lack of a NOAEL.
d. Exposure Assumptions
Revised acute and chronic dietary risk analyses for coumaphos were conducted with the
Dietary Exposure Evaluation Model (DEEM™). DEEM incorporates consumption data generated in
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-92. The dietary exposure
assessments presented in the "Revised Acute and Chronic Dietary Exposure and Risk Analyses for
Coumaphos" and in the "Revised Dietary and Occupational Risk Assessment Update for the
Coumaphos RED Published August, 1996" (both dated January 13, 2000) have been revised using the
correct residue values for pork commodities. For more details on this revision, please refer to the
memorandum entitled: "Addendum to the Acute Dietary Exposure Analysis for Coumaphos."
The Tier 3 acute dietary analysis used monitoring data for milk and percent livestock treated for
beef, milk, and pork commodities.
e.
Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population
Adjusted Dose does not exceed the Agency's risk concerns. The coumaphos acute dietary risk from
food is well below the Agency's level of concern; that is, less than 100% of the acute PAD is utilized.
For example, for the most exposed subgroups, infants (<1 year) and children (1-6 years), the percent
acute PAD values are 21% and 15%, respectively, at the 99.9th percentile of exposure.
11
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The chronic dietary risk from food alone is well below the Agency's level of concern. For the
most exposed subgroups, children (1-6 years) and children (7-12 years) the percent chronic PAD
values are 13% and 9%, respectively.
The revised Tier 3 acute and chronic dietary analyses are highly refined. Additional refinements
can be made using processing data from cooking and processing studies. These refinements will be
considered when the cumulative assessment for all of the organophosphates is conducted.
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 those risks. Modeling is
considered to be an unrefined assessment and provides a high-end estimate of risk. In the case of
coumaphos, no monitoring data for either ground or surface water were available; therefore, modeling
was used to estimate drinking water risks from these sources.
The GENEEC and SCI-GROW screening models were used to estimate surface water and
groundwater concentrations of coumaphos and its oxygen analog, coumaphoxon. This degradate is
considered in the drinking water assessment, because it is part of the tolerance expression.
The environmental fate database for coumaphos indicates that it is persistent (t1/2 >1 year) and
relatively immobile (Kd=61 to 298 ml/g; Koc=3,994 to 11,422) in soil. Since the Agency does not
have environmental fate data for coumaphoxon, it originally used the most conservative assumptions for
its persistence (t1/2 >1 year) and mobility (Koc=0.1) for drinking water assessment purposes. However,
on June 6, 2000, the Agency revised the drinking water assessment for coumaphos using a computer
estimation program (EPI version 3.04), and estimated less conservative K^ value (92.3) and water
solubility value (31.61 at 25 ° C) for coumaphoxon. Therefore, the estimated environmental
concentrations for total coumaphos (coumaphos and coumaphoxon) presented below reflect the
revised concentrations. Please refer to the document: "Revised Tier 1 Drinking Water Assessment for
Coumaphos," dated June 6, 2000 for more details.
For other model input parameters used in the drinking water assessment, the Agency used the
guidance it generated on proposed USDA land farming methods. The recommended application rate
for coumaphos spent solution from dip vat operations on non-agricultural land is 10,000 liters (L) of
coumaphos spent solution containing 10 ppb spread over a one-acre field. A conversion efficiency of
coumaphos to coumaphoxon of 10.2% was derived from available (supplemental) data on
photodegradation in water. This conversion efficiency was used to estimate a coumaphoxon
application rate of 0.02 Ibs ai/A.
12
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The Agency believes the revised environmental concentrations (EECs) are still conservative
estimates because most of the coumaphos spent solution resulting from the dip use on livestock is
collected and transported to concrete-lined evaporation pits, thereby negating any potential for
groundwater contamination.
a. Surface Water
Tier IGENEEC screening model, representing a worst-case runoff scenario for pesticides in
surface water, was used to estimate the upper-bound concentrations in surface water. Total
coumaphos (coumaphos + coumaphoxon) acute and chronic estimated environmental concentrations in
drinking water derived from surface water sources are not likely to exceed 1.86 ppb and 0.41 ppb,
respectively.
b. Ground Water
A Tier I screening model, SCI-GROW, was used to estimate total coumaphos concentrations
in ground water. This is an empirical model based on field data from prospective ground water studies.
Estimated environmental concentration of total coumaphos, representing acute and chronic exposures
to ground water, is 0.17 ppb.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by food
(and if appropriate, residential uses) and then determines a "drinking water level of
comparison"(DWLOC) 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. The DWLOC is the maximum concentration in drinking water which, when considered
together with dietary exposure, does not exceed a level of concern.
The results of the Agency's drinking water analysis are summarized herein. Details of this
analysis, which used screening models, are found in the "Revised Dietary and Occupational Risk
Assessment Update for the Coumaphos RED Published August, 1996," dated January 13, 2000. As
mentioned above, the June 16, 1999 drinking water assessment for coumaphos was revised on June 6,
2000. The revised coumaphos EECs are presented below in Tables 3 and 4. The reader is referred to
the "Revised Tier 1 Drinking Water Assessment for Coumaphos," dated June 6, 2000, for more
details.
For acute risk, potential exposure to drinking water derived from either ground or surface
water is not of concern for any population sub-group. The table below presents the calculations from
the acute drinking water assessment.
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Table 3. Summary of DWLOC Calculations for Acute Risk
Population
Subgroup
US
Population
Females
(13-50 years)
Infants (<1
year)
Acute PAD
(mg/kg/day)
0.007
0.007
0.007
Food Exposure
(mg/kg/day)
0.000525
0.000247
0.001492
Allowable
Water Exposure
(mg/kg/day)
0.006475
0.006669
0.005508
Ground
Water EEC
(Ppb)
(SCI-
GROW)
0.17
0.17
0.17
Surface Water
EEC (ppb)
(GENEEC)
1.9
1.9
1.9
DWLOC
(ppb)
227
200
55
For chronic risk, potential exposure to drinking water derived from ground water is not of
concern. Average (chronic) EECs in ground water do not exceed OPP's levels of comparison or
DWLOCs for any population sub-group.
Table 4. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S.
Population
Children (1-6
years)
Females (13-
50 years)
Chronic PAD
(mg/kg/day)
0.0003
0.0003
0.0003
Food Exposure
(mg/kg/day)
0.000013
0.000033
0.000009
Allowable
Water Exposure
(mg/kg/day)
0.000287
0.000267
0.000291
Ground
Water
EEC
(Ppb)
0.17
0.17
0.17
Surface Water
EEC
(Ppb)
(GENEEC)
0.41a
0.41
0.41
DWLOC
(ppb)
10
2.7
8.7
a The GENEEC model estimated 56-day (average) concentration is divided by a factor of 3 prior to comparison with the
DWLOCcteomc. In this case, (1.2 ppb)/3 = 0.41 ppb.
3. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes) and residential exposure to homeowners who handle pesticides or children who
incidentally become exposed to these chemicals (e.g., hand-to-mouth exposure, turfgrass ingestion) in
residential areas. Since coumaphos has no residential uses, acute and chronic aggregate risks include
exposures from food and drinking water only. Acute exposure refers to the exposure for one day and
chronic refers to that of a lifetime. Generally, all risks from these exposures must have MOEs of
greater than 100 to be not of concern to the Agency. Results of the aggregate risk assessment are
summarized herein, and are discussed extensively in the "Revised Dietary and Occupational Risk
Assessment Update for the Coumaphos RED Published August, 1996," dated January 13, 2000.
14
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Acute and chronic aggregate risks are not of concern for the Agency. When residues of
coumaphos in drinking water are considered with exposures from food uses, the resulting acute and
chronic aggregate human health risks are within acceptable levels.
4. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Residents or homeowners can be exposed to a pesticide through
mixing, loading, or applying a pesticide, or through entering or performing other activities on treated
areas. Since the only registered uses of coumaphos are on livestock and swine bedding, occupational
handlers of coumaphos are limited to individual farmers and USD A-APHIS workers who mix, load,
and/or apply the pesticide. Risk for all of these potentially 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. In the case of coumaphos, the inhalation target MOE is 300, due to
the uncertainty associated with the use of a LOAEL, and the dermal target MOE is 100.
a. Toxicity
The toxicity of coumaphos is integral to assessing the occupational risk. All risk calculations are
based on the most current toxicity information available for coumaphos, including 21-day dermal and
5-day dermal toxicity studies. The lexicological endpoints, and other factors used in the occupational
risk assessment for coumaphos are listed below.
Table 5a. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessment for Coumaphos
Assessment
Short-term dermal
Intermediate- term
dermal
Short-term
inhalation
Intermediate -term
inhalation
Dose
NOAEL = 5.0
mg/kg/day
NOAEL = 0.5
mg/kg/day
LOAEL=2.0
mg/kg/day
LOAEL=0.2
mg/kg/day
Endpoint
Brain ChE inhibition
in female rats
RBC ChE inhibition
in rats
Plasma ChE
inhibition in female
rats and RBC ChE
inhibition in male anc
female rats
RBC ChE rnhrbmon
in rats
Study
5-day dermal toxicity study in
rats (MRID 44749401)
2 1 -day dermal toxicity study
rn rats (42084901)
Acute oral neurotoxicity stud)
rn rats (MRID 44544801)
13 -week dietary study in rats
(MRID 00126527)
Absorption
factor
N/A
N/A
1 00 percent
absorption
assumed
1 00 percent
absorption
assumed
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Coumaphos technical is highly acutely toxic via the oral (toxicity category I) and inhalation
routes of exposure (toxicity category n). It is moderately toxic via the dermal route of exposure
(toxicity category HI) and is not a dermal sensitizer or irritant. Coumaphos is classified as a Group E
chemical, indicating that it is "Not Likely" to be carcinogenic in humans via relevant routes of exposure.
Table 5b. Acute Toxicity Profile for Occupational Exposure for Coumaphos
Route of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
Category Basis
LD50 > 240 mg/kg - male rat; LD50 =17 mg/kg - female rat
(MRID 001 10597)
LD50> 2400 mg/kg - male and female rats (MRID 001 10598)
1 hour inhalation LC50 = 1 .081 mg/L -male rat; 1 hour inhalation L
= 0.341 mg/L female rat (MRPD 001 10601)
Mild irritant, resolved by day 7 (MRID 001 10599)
Not irritating (MRID 001 10600)
Not a sensitizer (MRID 001 10602)
Toxicity Category
I
III
^50 II
III
IV
N/A
b. Exposure
Coumaphos-specific handler exposure data were not available, so risks to pesticide handlers
were assessed using data from the Pesticide Handlers Exposure Database (PHED) for most of the
identified occupational exposure scenarios. Since PHED does not contain data to assess exposures
resulting from loading and applying dust formulations, for informational purposes, the Agency used the
published study: "Application Exposure to the Home Gardener" (1985) to estimate dermal exposure
associated with dust application to livestock. However, the Agency believes the exposures derived
from this study are an under estimate. This is because the exposures from applying a dust formulation
to low garden vegetables will be very different from applying to livestock which are taller, mobile, and
more active.
The Occupational and Residential Exposure Task Force (ORETF) study submitted by the
technical registrant presents inhalation and dermal exposures estimates from applying dusts to garden
vegetables and could not be used to assess exposure to handlers likely to occur from the use of
coumaphos on livestock. Our concerns for the dermal exposure estimates derived from this study
were the same as our concerns were for the 1985 data. For the inhalation exposure, EPA believes the
exposures from applying dusts to relatively tall, moving livestock are likely to be significantly higher than
those resulting from the application of dusts to low-growing plants since it is likely that more dust will
reach the applicator's breathing zone during application to livestock. Therefore, the Agency had no
data to estimate inhalation exposure from loading and/or applying dust formulations.
Standard assumptions including average body weight, work day, daily animals or area treated,
and volume of pesticide were used to calculate risk estimates. The quality of the data and exposure
16
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factors represent the best sources of data currently available to the Agency for completing these kinds
of assessments. These exposure factors 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 revised
"Occupational Exposure and Risk Assessment Updating the Coumaphos RED Published August,
1996," dated December 28, 1999, 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 coumaphos labels range
from 0.005 to 0.025 pounds of active ingredient per gallon for sprays and dips, 0.076 Ibs ai/gallon of
oil for back rubbers, 0.000625 to 0.013 Ibs ai/animal for dust, and 0.042 Ibs ai/1,000 sq. ft. of swine
bedding. The Agency typically uses number of animals or area treated per day that are thought to
represent 8 solid 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 tier is represented by the baseline exposure
scenario, followed by, if required (i.e., MOEs are less than 100), increasing levels of risk mitigation,
such as personal protective equipment (PPE) and engineering controls (EC). Some of the current
labels of coumaphos products require handlers to wear long pants, long-sleeved shirt, and chemical-
resistant gloves. The levels of protection that formed the basis for calculations of exposure from
coumaphos activities include:
Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Label: Long-sleeved shirt and long pants, chemical-resistant footwear plus
socks and chemical-resistant gloves. (Note: labels of coumaphos liquid
products currently registered require this PPE)
Additional PPE: Baseline + coveralls, chemical-resistant gloves, chemical-resistant
apron and a respirator.
• Engineering controls: A closed mixing/loading system, for example, a farm closed mechanical
transfer system for liquids or a packaged based system. 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).
All the occupational exposure scenarios identified are of short-term duration (i.e., less than
seven days), except for mixing and loading coumaphos for cattle dip vats, which is considered a short-
term and an intermediate-term (i.e., duration is seven days to several months) occupational exposure
scenario. Most of the non-dip vat uses of coumaphos are performed by farmers on their own animals
17
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when arthropod pests become a problem. Mixing and loading liquids for dip vat operations carried out
by USD A-APHIS are not considered chronic exposures. Chronic exposures are exposures of more
than 180 days per year. USD A-APHIS employees who conduct dip vat operations are expected to
be exposed on a daily basis of no more than 60 days.
c. Occupational Handler Risk Summary
In the revised assessment, EPA assessed handler risk using different lexicological endpoints
and uncertainty factors for dermal and inhalation exposures. For coumaphos, the inhalation target
MOE for the short-term and intermediate-term exposures is 300 and the dermal target MOE for short-
term and intermediate-term exposures is 100. These risks were then combined into an Aggregate Risk
Index (ARI). This method is used when the uncertainty factors associated with dermal and inhalation
doses of concern are different and the endpoints are the same, i.e., cholinesterase inhibition. ARIs
show how close the total exposure was to the dose at which no adverse effect was observed
(NOAEL), except where no inhalation data were available. In these latter cases, only dermal MOEs
were calculated. Additionally, the risk associated with certain handler exposure tasks were combined
to represent one exposure scenario (e.g., a farmer mixing, loading and applying a spray solution to his
own livestock). All the occupational exposure scenario descriptions, assumptions and estimated risks
presented herein are included in Tables 3-9 of the revised "Occupational Exposure and Risk
Assessment Updating the Coumaphos RED Published August 1996," dated December 28, 1999.
Refer to these tables for more information on the assessment.
The following tables summarize the risk concerns after the occupational risk assessment was
revised to include the most current data and assumptions for occupational handlers. The tables
presented in this summary document outline the occupational handler risks at baseline, current PPE, and
provide the risk estimates for each of these scenarios separately with additional PPE and, in some
cases, with engineering controls to show the level of risk mitigation that could be achieved. Note that
ARIs < 1 (for combined exposure), MOEs < 100 (for dermal exposure) and MOEs < 300 (for
inhalation exposure) represent risks of concern for the Agency. More details on the description of each
occupational exposure scenario, data sources and data quality may be found in Tables 3-9 of the
revised "Occupational Exposure and Risk Assessment Updating the Coumaphos RED Published
August 1996," dated December 28, 1999.
1) Occupational Handler Risk
The Agency identified eleven major occupational handler scenarios associated with the use of
coumaphos and assessed risks for eight short-term and two intermediate-term exposure scenarios.
However, the Agency did not develop an informational risk assessment for loading dusts into dust bags
due to the lack of surrogate exposure data. The ten scenarios assessed represent twenty-three
combinations of different application methods, formulations, use rates, number of animals/area treated
for the short-term and intermediate-term exposures assessed. Seven of the nine short-term exposure
18
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scenarios and two intermediate-term exposure scenarios pose risk concerns at baseline. ARIs
presented in the tables below represent combined dermal and inhalation MOEs, except for those
exposure scenarios related to the handling of the dust formulation for which no inhalation data were
available. Dermal MOEs corresponding to the handling of dusts are presented in this document for
informational purposes only, because exposure data used to calculate these MOEs were derived from a
vegetable garden exposure scenario, which the Agency believes underestimates exposures to handlers
from dust application to livestock. The exposure scenarios of concern at baseline are listed below and
in Tables 6a and 6b; the number preceding each of them corresponds to the scenario number given in
the occupational risk assessment document.
The short-term exposure scenarios of concern at baseline are:
(la) Mixing/loading (M/L) liquids for high pressure handwand (at the application rate for
cattle/horse, handling a volume of 100 gallons/day). ARI for this exposure scenario is
0.57; the risk is driven by dermal exposure.
(Ib) M/L liquids for hydraulic type dip vats (1,800 gal/day). ARI for this exposure scenario
is 0.027; the risk is driven by dermal exposure.
(Ic) M/L liquids for swim dip vats (4,000 gal/day). ARI for this exposure scenario is 0.012;
dermal exposure drives the risk.
(3) Applying liquids for high pressure hand wand (at the application rate for cattle/horse,
handling a volume of 100 gal/day). ARI for this exposure scenario is 0.70; risk is
driven by dermal exposure.
(4) Applying dusts with a shaker can (at the application rate for cattle/horse, treating 50
animals/day; at the application rate for swine, treating 50 animals/ day; and at the
application rate for swine bedding, treating 1000 sq. ft./day). Dermal MOEs for these
exposure scenarios are 27, 55, and 41, respectively. Although the dermal MOEs were
estimated based upon exposures from the application of dusts to garden vegetables,
and are likely an underestimate, the Agency believes they provide a reasonable frame
of reference to qualitatively assess risks to applicators from applying dusts to livestock
and swine bedding. No inhalation data were available to assess risks associated with
the application of dusts to livestock.
(5) Mixing/loading/applying (M/L/A) liquids with a low pressure hand wand (at the
application rate for cattle/horse, handling 40 gal/day; and at the application rate for
swine, handling 40 gal/day). ARIs are 0.042 and 0.17, respectively; risks are driven by
the dermal route of exposure.
19
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(6) Loading/applying dust with a mechanical duster (at the application rate for cattle/horse,
treating 50 animals/day; at the application rate for swine, treating 50 animals/day; and at
the application rate for swine bedding, treating 1000 sq. ft./day). Qualitative dermal
MOEs for these exposure scenarios are 27, 55, and 41, respectively. No inhalation
data were available to assess risks associated with the application of dusts to livestock.
It should be noted that individual farmers who treat only their own cattle are more likely to have
short-term exposures (i.e., exposures of seven days or less) than other handlers, such as USDA-
APHIS staff, who operate the dip vats and could be exposed to coumaphos multiple times over the
course of one week or several months.
The intermediate-term exposure scenarios of concern at baseline are:
(Ib) M/L liquids for hydraulic type dip vats (450 gal/day), ARI=0.011;
(Ic) M/L liquids for swim dip vats (1000 gal/day), ARI=0.0048.
The risks calculated from these two exposure scenarios are driven by the dermal route of exposure.
20
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Table 6a. Coumaphos Short-Term Dermal and Inhalation Occupational Handler Risks Exceeding Levels of Concern at Baseline
Scenario
(la) M/L liquids for
high pressure
handwand
(Ib) M/L liquids for
hydraulic type dip
vats
(Ic) M/L liquids for
swim dip vats
(3) Applying liquids
for high pressure
hand wand
(4) Applying dusts
with a shaker can4
Daily
animals/
area
treated
or
amount
used
100
gal/day
1800
gal/day
4000
gal/day
100
gal/day
50
animals/
day
50
animals/
day
1000 sq.
ft./day
Animal
cattle/
horse
cattle
cattle
cattle/
horse
cattle/
horse
swine
swine
bedding
Rate
211bs
ai/1000
gal
251bs
ai/1000
gal
251bs
ai/1000
gal
211bs
ai/1000
gal
0.0013
Ibs
ai/animal
0.000625
Ibs
ai/animal
0.042 Ibs
ai/1000
sq. ft.
Short-term ARIs
Baseline1
Dermal
MOE
60
3
1
93
27
55
41
Inhalation
MOE
56,000
2,600
1,200
840
no data
no data
no data
ARI
0.57
0.027
0.012
0.70
--
—
Current Label PPE2
Dermal
MOE
7,200
-
—
260
--
—
Inhalation
MOE
56,000
—
—
840
--
~
ARI
52
—
—
1.4
--
—
Additional PPE3
Dermal
MOE
9,800
460
210
460
48
100
74
Inhalation
MOE
280,000
13,000
5,800
4,200
no data
no data
no data
ARI
87
4
1.9
3.5
--
_
—
21
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Scenario
(5) M/L/A liquids
with a low pressure
hand wand
(6) L/A dust with a
mechanical duster4
Daily
animals/
area
treated
or
amount
used
40
gal/day
40
gal/day
50
animals/
day
50
animals/
day
1000 sq.
ft./day
Animal
cattle/
horse
swine
cattle/
horse
swine
swine
bedding
Rate
211bs
ai/1000
gal
51bs
ai/1000
gal
0.0013
Ibs
ai/animal
0.000625
Ibs
ai/animal
0.042 Ibs
ai/1000
sq. ft.
Short-term ARIs
Baseline1
Dermal
MOE
4
18
27
55
41
Inhalation
MOE
5,600
23,000
no data
no data
no data
ARI
0.042
0.17
—
Current Label PPE2
Dermal
MOE
970
4,000
—
Inhalation
MOE
5,600
23,000
—
ARI
6.3
27
—
Additional PPE3
Dermal
MOE
1,100
4,700
48
100
74
Inhalation
MOE
28,000
120,000
no data
no data
no data
ARI
10
42
—
1 Long pants, long sleeved shirt, no gloves, open mixing/loading, no respirator
2 Long-sleeved shirt and long pants, chemical-resistant footwear plus socks and chemical-resistant gloves. (Note: this PPE is in some of the currently registered
coumaphos product labels)
3 Double-layer of clothing, coveralls, chemical-resistant apron and chemical-resistant gloves, dust/mist respirator
4 Dermal MOEs corresponding to the handling of dusts are presented in this document for informational purposes only. Exposure data used to calculate these
MOEs were derived from a vegetable garden exposure scenario, which the Agency believes underestimates exposures to handlers from dust application to
livestock.
22
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Table 6b. Coumaphos Intermediate-Term Dermal and Inhalation Occupational Handler Risks Exceeding Levels of Concern at
Baseline
Scenario
(lb)M/L liquids
for hydraulic type
dip vats
(Ic) M/L liquids for
swim dip vats
Daily
animals
/area
treated
or
amount
used
450
gal/day
1000
gal/day
Animal
cattle
cattle
Rate
251bs
ai/1000 gal
251bs
ai/1000 gal
Intermediate-term ARIs
Baseline1
Dermal
MOE
1
0.48
Inhalation
MOE
1,000
470
ARI
0.011
0.0048
Additional PPE2
Dermal
MOE
180
82
Inhalation
MOE
5,200
2,300
ARI
1.7
0.74
Engineering Controls 3
Dermal
MOE
—
160
Inhalation
MOE
—
6,700
ARI
—
1.5
1 Long pants, long sleeved shirt, no gloves, open mixing/loading, no respirator
2 Double-layer of clothing, coveralls, chemical-resistant apron and chemical-resistant gloves, dust/mist respirator
3 Closed mixing/loading, single layer of clothing, chemical resistant gloves.
23
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2) Post-Application Occupational Risk
The Agency determined that there is likely to be minimal exposure to people contacting treated
animals after application is complete and believes exposure is relatively lower than that to handlers.
Therefore, post-application exposure was not assessed. In addition, current labeling does not permit
contact with treated livestock immediately after application.
B. Environmental Risk Assessment
This RED Addendum does not include an environmental risk assessment for coumaphos. The
Agency did not conduct a new environmental risk assessment for the effects of coumaphos on non-
target species (e.g., fish, birds, mammals), because we have no reason to believe our conclusions
would change since the 1996 RED.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA 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.,
active ingredient specific) data to support reregistration of products containing coumaphos as an active
ingredient.
In the Coumaphos Reregistration Eligibility Decision (RED) of 1996, the Agency established
that USD A-APHIS uses of coumaphos were eligible for reregistration because the use of this
insecticide is very important to the USD A-APHIS Cattle Fever Tick Eradication Program and the U.S.
economy. USDA estimated the economic significance of the use of coumaphos to be between $1-5
billion dollars per year. With this program, USDA-APFflS has helped in preventing the re-
establishment of the cattle fever tick and its associated disease, piroplasmosis (babesiosis), into the
United States.
EPA also considered the cholinesterase monitoring program currently run by USD A-APHIS in
making the USD A-APHIS uses eligible for reregistration. As part of this program, all APHIS
employees exposed to any carbamate or organophosphate pesticide as a result of handling the pesticide
in concentrated or diluted form, reentering a treated field, or being exposed to drift are required to be
monitored for cholinesterase levels before assuming their duties to establish baseline, and every 60 days
thereafter. If cholinesterase levels in blood serum indicate a significant drop (50 percent or more from
the highest baseline result, regardless of whether it is within the normal range, males: 10.1-22.1 U/ml
and females: 8.3-20U/ml) or an abnormal result (less than 8.0 U/ml), APHIS will relieve the employee
24
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from work involving contact with the pesticide, retest the employee in 30 days and prevent the
employee from returning to work until another sample shows normal cholinesterase levels.
In the 1996 RED, the Agency deferred making a reregistration eligibility decision for
coumaphos uses other than those to control cattle fever tick by USDA-APHIS until chemical-specific
handler studies were submitted and reviewed. These handler studies were required from the registrant
in a generic Data Call-in (DCI) issued as part of the 1996 RED. However, more recently, based on
the small volume and declining trend in the use of coumaphos as livestock and swine bedding animal
treatments, the Agency determined the chemical-specific handler exposure studies were not needed.
The Agency has completed its assessment of the occupational risk associated with the use of
pesticides containing the active ingredient coumaphos, as well as a coumaphos-specific dietary risk
assessment. However, the Agency has not yet considered the cumulative effects of organophosphates
as a class. Based on a review of surrogate handler exposure data submitted by the technical registrant,
dietary and handler exposure data available to the Agency and public comments on the Agency's
assessments for the active ingredient coumaphos, EPA has sufficient information on the human health
effects of coumaphos to make a determination of reregistration eligibility for the non-USD A uses and to
make some decisions as part of the tolerance reassessment process under FQPA. Although the
Agency has not yet completed its cumulative risk assessment for the organophosphates, the Agency is
issuing this assessment now in order to identify risk reduction measures that are necessary to allow the
continued use of coumaphos. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of coumaphos, and lists the submitted
studies that the Agency found acceptable.
As a result of its assessment of the remaining risks of coumaphos alone, EPA has determined
that certain uses of coumaphos, unless amended as set forth in this document, present risks inconsistent
with FIFRA. Accordingly, EPA may commence a full risk/benefit analysis, the outcome of which may
indicate that cancellation proceedings are warranted, unless registrants agree to label changes
implementing the risk reduction measures discussed in this reregistration eligibility decision. At the time
that a cumulative assessment is conducted, the Agency will address any outstanding risk concerns.
However, the Agency may take further actions or require additional studies, if warranted, to finalize the
reregistration eligibility decision for coumaphos after assessing the cumulative risk of the
organophosphate class. Such an incremental approach to the reregistration process is consistent with
the Agency's goal of improving the transparency of the reregistration and tolerance reassessment
processes. By evaluating each organophosphate in turn and identifying appropriate risk reduction
measures, the Agency is addressing the risks from the organophosphates in as timely a manner as
possible.
Since the Agency has not yet completed the cumulative risk assessment for the
organophosphates, this reregistration eligibility decision does not fully satisfy the reassessment of the
existing coumaphos food residue tolerances as called for by the Food Quality Protection Act (FQPA).
25
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When the Agency has completed the cumulative assessment, coumaphos tolerances will be reassessed
in that light. At that time, the Agency will reassess coumaphos along with the other organophosphate
pesticides to complete the FQPA requirements and make a final reregistration determination. By
publishing this reregistration eligibility decision and requiring risk mitigation now for the individual
chemical coumaphos, the Agency is not deferring or postponing FQPA requirements; rather, EPA is
taking steps to assure that uses which exceed FIFRA's unreasonable risk standard do not remain on
the label indefinitely, pending completion of assessment required under the FQPA. This decision does
not preclude the Agency from making further FQPA determinations and tolerance-related rulemakings
that may be required on this pesticide or any other in the future.
If the Agency determines, before fmalization of this document, that any of the determinations
described herein are no longer appropriate, the Agency will pursue appropriate action, including but not
limited to, reconsideration of any portion of this document.
B. Summary of Phase 5 Comments and Responses
When making its reregistration decision, the Agency took into account all comments received
during Phase 5 of the OP Pilot Process. Comments on risk mitigation were only submitted by the
technical registrant, Bayer Corporation. These comments in their entirety are available in the docket.
A brief summary of the comments and the Agency response is noted here.
Comment. Bayer commented that submitted worker exposure studies and an upcoming environmental
fate study address each of the Agency's identified risk concerns. To address risk concerns associated
with the application of liquid and dust formulations, the registrant has submitted surrogate exposure data
from the Outdoor Residential Exposure Task Force (ORETF), which Bayer believes yield adequate
margins of safety. In addition, Bayer has deleted the use of the mechanical duster from all its dust end-
use products. Regarding the drinking water dietary risk concern presented in the Agency's "Revised
Dietary and Occupational Risk Assessment Update for the Coumaphos RED Published August, 1996,"
Bayer has conducted and will be submitting an absorption/desorption study on coumaphoxon that the
registrant believes will allow the Agency to refine the conservative assumption for the K^ of
coumaphoxon and that this value, in turn, would yield ground water EECs well below the Agency
DWLOCs.
Response. The ORETF study estimated exposure from applying dusts to a garden. The Agency
believes inhalation exposures from applying dust to livestock are likely to be significantly higher than
those resulting from applying dusts to low-growing garden plants. Livestock are tall and move while
dust application is taking place, therefore, livestock are closer to the applicator's breathing zone than
garden plants. Although the Agency has no exposure study with which to estimate the inhalation
exposure likely from applying dust to livestock and swine bedding with a shaker can or loading dust
into dust bags, EPA believes that adding a dust/mist respirator is a prudent risk reduction measure.
26
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Regarding the dietary (drinking water) risk concern, the Agency has revised the drinking water
assessment (please refer to the "Revised Tier 1 Drinking Water Assessment for Coumaphos," dated
June 6, 2000) to reflect more realistic environmental fate parameters, and estimated coumaphos
concentrations in ground water do not exceed the chronic DWLOCs. Therefore, the Agency has no
chronic aggregate (food and water) risk concerns at this time. As an additional safety measure, the
Agency and the registrant have agreed that coumaphos solution from dip vat use be disposed of in
concrete-lined pits. The Agency also encourages Bayer to submit the final study report for the
absorption/desorption study on coumaphoxon.
Comment. Bayer commented that, even though it believes adequate margins of safety exist with the
ORETF worker exposure studies, it is willing to implement several risk mitigation measures, such as
limiting the dip vat use of coumaphos to only USD A and maintaining the current label limit of 100
gallons per day for the treatment of livestock with hand held sprayers at the maximum application rate.
Response. The Agency has reviewed risk mitigation measures proposed by Bayer and determined that
these measures would adequately address the Agency's occupational risk concerns associated with the
use of coumaphos in dip vat operations and with the application of liquid formulations as spray using
hand held sprayers. However, additional measures are necessary to mitigate the remaining
occupational risk concerns. These measures are outlined in the "Label Modifications" section of this
document.
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this organophosphate. The assessment was 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 from substances sharing a common mechanism of
toxicity, such as the toxicity expressed by the organophosphates through a common biochemical
interaction with the cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the
entire class of organophosphates once the methodology is developed and the policy concerning
cumulative assessments is resolved.
EPA has determined that risk from exposure to coumaphos is within its own "risk cup." In
other words, if coumaphos did not share a common mechanism of toxicity with other chemicals, EPA
would be able to conclude today that the tolerances for coumaphos meet the FQPA safety standards.
In reaching this determination, EPA has considered the available information on the special sensitivity of
infants and children, as well as the chronic and acute food exposure. An aggregate assessment was
conducted for exposures through food and drinking water. Results of this aggregate assessment
27
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indicate that the human health risks from these combined exposures are within acceptable levels; that is,
combined risks from all exposures to coumaphos "fit" within the individual risk cup. Therefore, the
coumaphos tolerances remain in effect until a full reassessment of the cumulative risk from all
organophosphates is completed, except for those tolerances no longer supported, which will be
revoked.
b. Tolerance Summary
In the individual assessment, tolerances for residues of coumaphos in/on meat, fat, and meat
byproducts [40 CFR §180.189] are presently expressed in terms of combined residues of parent
coumaphos and its oxygen analog, coumaphoxon. The Agency has determined that no changes to the
milk, cattle, horse and hog tolerances are presently required. Six coumaphos tolerances for residues in
meat, fat, and meat byproducts of goats and sheep should be proposed for revocation, since the
technical registrant no longer supports these uses and has requested voluntary cancellation of these uses
from all its registered product labels.
Table 7. Tolerance Summary for Coumaphos
„ ,. Current Tolerance, Interim Tolerance _,
Commodity _ . . , Comment
ppm Decision , ppm
Tolerances Listed Under 40 CFR §180.189
Cattle, fat
Cattle, MBYP
Cattle, meat
Goats, fat
Goats, MBYP
Goats, meat
Hogs, fat
Hogs, MBYP
Hogs, meat
Horses, fat
Horses, MBYP
Horses, meat
Milk, fat
Sheep, fat
Sheep, MBYP
Sheep, meat
1
1
1
1
1
1
1
1
1
1
1
1
0.5
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.5
1
1
1
To be revoked
To be revoked
To be revoked
To be revoked
To be revoked
To be revoked
'Tolerances may only be reassessed upon completion of the cumulative risk assessment of all organophosphates, as required by
FQPA. The tolerances provided in this table are for this single chemical and are supported by all of the submitted residue data.
28
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The Agency will commence proceedings to revoke six tolerances for sheep and goat (fat,
MBYP, and meat tolerances for each) as soon as the registrant's request has gone through the
voluntary cancellation process, including the publication of notice in the "Federal Register," as
established by FIFRA.
On August 16, 2000, the Agency established two time-limited tolerances for combined residues
of coumaphos and its oxygen analog, coumaphoxon, in or on honey (0.1 ppm) and beeswax (100
ppm), in response to the emergency exemptions granted under section 18 of FIFRA, authorizing the
use of the pesticide in beehives. These tolerances will expire on December 31, 2002 (65 FR 49927).
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 was scientific basis for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have
an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, coumaphos may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
coumaphos. Where labeling revisions are imposed, specific language is set forth in the summary tables
of Section V of this document.
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1. Human Health Risk Mitigation
a. Dietary Risk Mitigation
1) Acute Dietary (Food)
Acute dietary risk from food is well below the Agency's level of concern. A Tier 3 acute dietary
exposure assessment was performed using DEEM™, and analysis yielded a percent acute PAD value
of 21% for the most highly exposed population subgroup, infants < 1 year, at the 99.9th percentile.
Therefore, no risk mitigation measures are necessary at this time to address acute dietary risk from
food.
2) Chronic Dietary (Food)
Chronic dietary risk from food is also well below the Agency's level of concern. A Tier 3
chronic dietary exposure assessment was performed using DEEM™ and analysis yielded a percent
acute PAD value of 13% for the most highly exposed population subgroup, children 1-6 years.
Therefore, no risk mitigation measures are necessary at this time to address chronic dietary risk from
food.
3) Drinking Water
Acute exposure to drinking water from surface or ground water sources is not of concern;
estimated coumaphos concentrations in surface and ground water do not exceed the acute DWLOCs.
No mitigation is necessary at this time to reduce risks resulting from acute drinking water exposure.
Chronic exposure to drinking water from surface water sources is not of concern. In the revised
risk assessment for coumaphos released on April 26, 2000, the Agency identified a potential chronic
risk concern from exposures to drinking water derived from groundwater sources. However, the
Agency revised the drinking water assessment to reflect more realistic environmental fate parameters,
and current estimated environmental concentrations of coumaphos in ground water do not exceed the
chronic DWLOCs for any population sub-group. The revised document: "Revised Tier 1 Drinking
Water Assessment for Coumaphos," dated June 6, 2000, is available in the OPP Public Docket for
coumaphos.
To further reduce the possibility of groundwater contamination resulting from the disposal of
bioremediated coumaphos spent solution from dip vat operations, the technical registrant agreed to
incorporate the following risk mitigation measure, in addition to existing label requirements:
• Restrict the disposal of bioremediated coumaphos spent solution from dip vat operations
to shallow, concrete-lined evaporation ponds.
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b. Occupational Risk Mitigation
To address risk from dermal and inhalation exposures for the handler scenarios presented in
Section m of this document and shown in Tables 6a and 6b of that section, the risk mitigation measures
presented below, in addition to existing label requirements and label modifications established in the
Coumaphos RED of 1996, need to be incorporated into labels.
For the liquid products:
Restrict the use of the 42% flowable product to USDA-APfflS staff enrolled in the
USDA-APHIS cholinesterase monitoring program; and
Maintain the current use restriction on the liquid formulations, limiting the number of
animals an individual may treat with hand held sprayers tolOO head per day at the
maximum application rate, and move this restriction to a more prominent place on the
labels.
At baseline, risks to handlers from mixing/loading and applying liquids for high-pressure hand
wand at the application rate for cattle/horse (ARI=0.057) and at the application rate for swine
(ARI=0.24) exceed the Agency's level of concern at a higher use rate of 1,000 gallons per day. The
Agency estimates that one gallon of dilute is used per animal. Therefore, the current label restriction on
all liquid products limiting the number of animals an individual can treat with hand held sprayers to 100
head per day at the maximum application rate needs to be maintained (200 head per day if they are
treated at /^ maximum label rate, etc.").
The use restriction of 100 head per day at the maximum application rate and at currently
required level of personal protection yields occupational risk estimates that are not of concern to the
Agency. ARIs for exposure from mixing/loading of liquids for high-pressure hand wand (scenario la)
and for exposure from applying liquids with high-pressure hand wand (scenario 3) are 52 and 1.4,
respectively. Current liquid product labels require that handlers use chemical-resistant gloves, which is
a protective equipment not considered at baseline.
For the dust products:
• Prohibit the use of mechanical dusters as a method of application for coumaphos technical,
all dust manufacturing-use products and all dust end-use products;
Require the use of a dust/mist respirator and a chemical-resistant apron on all dust product
labels; and
-------
Limit the number of animals an individual may treat with dust products by use of a shaker
can to 25 head per day and the swine bedding area treated to 1,000 sq. ft. per day.
The Agency had no handler exposure data to assess dermal and inhalation risks associated with
the application of coumaphos dusts to livestock and swine bedding. However, dermal risk to
applicators based on surrogate exposure studies provided a frame of reference. In the absence of data,
as a prudent safety precaution, EPA has determined that a dust/mist respirator and a chemical-resistant
apron are necessary to mitigate occupational risks from the use of coumaphos dust products.
E. Label Modifications
The Agency has determined that the coumaphos registration should be amended to mitigate risks
to handlers from use of coumaphos on livestock and swine bedding. The Agency believes the
measures presented above, in addition to existing label requirements, will reduce worker risks of
concern to acceptable levels and that unreasonable adverse effects are unlikely to result from such uses
or practices. In addition, the technical registrant agreed to implement additional risk mitigation
measures to prevent potential groundwater contamination resulting from the disposal of coumaphos
waste solution on non-agricultural land.
The technical registrant does not support the use of coumaphos on sheep and goats and has
indicated its intention to request voluntary cancellation of these two uses from all coumaphos
manufacturing-use and end-use products; therefore, the following measure needs to be incorporated
into labels:
Restrict the formulation of coumaphos products for use on beef cattle, dairy cattle, horses,
swine and swine bedding uses only.
Provided the risk mitigation measures are incorporated in their entirely into labels for
coumaphos-containing products, the Agency finds that all currently registered uses of coumaphos are
eligible for reregistration, pending a cumulative assessment of the organophosphate pesticides.
F. Other Labeling Modifications
In order to be eligible for reregistration, other use and safety information need to be placed on
the labeling of all end-use products containing coumaphos. For the specific labeling statements, refer to
Table 8 in Section V of this document.
32
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1. Endangered Species Statement
The Agency has developed a program ("The Endangered Species Protection Program") to
identify pesticides whose use may cause adverse impacts on endangered and threatened species and to
implement mitigation measures that will eliminate the adverse impacts. At present, the program
provides information to users to help them protect these species on a voluntary basis. As currently
planned, the final program will call for label modifications referring to limitations on pesticide uses,
typically as depicted in county-specific bulletins or by other site-specific mechanisms as specified by
state partners. A final program will be described in a future "Federal Register" notice. The Agency is
not imposing label modifications at this time through the RED. Rather, any requirements for product
use modification will occur in the future under the Endangered Species Protection Program.
V. WHAT REGISTRANTS NEED TO DO
A. Manufacturing-Use Products
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section IV, by submitting label amendments and meeting the data requirements
described in this section.
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of coumaphos for the above eligible uses has
been reviewed and determined to be essentially complete. The following data gap remains:
• Developmental Neurotoxicity Study, Guideline No. 870.6300
A Data Call-In Notice (DCI) sent on September 10, 1999 to registrants of organophosphate
pesticides currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18, 1999
64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity
studies; due dates are 9/2001. The technical registrant of coumaphos requested a generic data waiver
to the developmental neurotoxicity study, and the Agency denied such request in a letter dated March
10, 2000. Currently, the registrant intends to support the registration of coumaphos and has committed
to submit the required developmental neurotoxicity study. As stated in the Agency's March 10 letter to
Bayer Corporation, the DCI issued in September 1999 supercedes previous chemical-specific
determinations that may have been rendered by the Agency. The Agency acknowledges that the
revised risk assessments and supporting documents for coumaphos contain outdated statements that a
developmental neurotoxicity study in rats is not required. These statements are not correct. The
toxicology data base for coumaphos has not been completely fulfilled, and the developmental
neurotoxicity study is still required.
33
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2. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MPs) labeling should be
revised to comply with all current EPA regulations, PR Notices and applicable policies. In addition,
labeling changes are necessary to implement measures outlined in Section IV above.
The Agency is reviewing revised labeling submitted by the registrants in response to the label
changes outlined in the 1996 Coumaphos RED to determine which additional modifications are needed
to reflect the reregistration conditions specified in this RED Addendum. The Agency will contact the
registrants if label changes, other than the ones already implemented, are necessary. Therefore,
registrants do not need to submit applications for amended registrations or draft labels at this time. The
Special Review and Reregistration Division contact for product reregistration is Moana Appleyard.
Her phone number is (703) 305-5428.
B. End-Use Products
1. Additional Generic Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. This RED Addendum does
not contain a product-specific data call-in, since it was issued in the 1996 Coumaphos RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific
language to implement these changes is specified in Table 8 at the end of this section. The Agency is
reviewing revised labeling submitted by the registrants in response to the label changes outlined in the
1996 Coumaphos RED to determine which additional modifications are needed to reflect the
reregistration conditions specified in this RED Addendum. The Agency will contact the registrants if
label changes, other than the ones already implemented, are necessary. Therefore, registrants do not
need to submit applications for amended registrations or draft labels at this time. The Special Review
and Reregistration Division contact for product reregistration is Moana Appleyard. Her phone number
is (703) 305-5428.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Reregistration Eligibility Decision Addendum document. Persons
other than the registrant may generally distribute or sell such products for 24 months from the date of
the issuance of this document. However, existing stocks time frames will be established case-by-case,
34
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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 coumaphos products bearing
old labels/labeling for 12 months from the date of issuance of this RED Addendum. Persons other than
the registrant may distribute or sell such products for 24 months from the date of the issuance of this
document. Registrants and persons other than the registrant remain obligated to meet pre-existing
Agency imposed label changes and existing stocks requirements applicable to products they sell or
distribute.
35
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D. Labeling Changes Summary Table
Table 8 contains labeling changes previously identified in the 1996 Coumaphos RED and additional changes established in this RED
Addendum for coumaphos. Labeling changes from both REDs should be incorporated in their entirety into labels for coumaphos-containing
products, in order for currently registered uses of coumaphos to be eligible for reregistration. The PPE that would be established on the basis
of acute toxicity category of the end-use product must be compared to the active-ingredient-based personal protective equipment specified in
Table 8. The more protective PPE should be placed on the product labeling. For guidance on which PPE is considered more protective, see
PR Notice 93-7.
Table 8: Summary of Labeling Changes for Coumaphos
Description
Amended Labeling Language
Placement on Label
Manufacturing-Use Products
Formulation Restriction
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
"Only for formulation into an insecticide for the following use(s): beef cattle, dairy cattle,
horses, swine and swine bedding."
"This product may not be used to formulate products for use in mechanical dusters."
"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
Directions for Use
Directions for Use
36
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Table 8: Summary of Labeling Changes for Coumaphos
Description
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
Amended Labeling Language
"This pesticide is toxic to birds, fish 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."
Placement on Label
Precautionary
Statements
End-Use Products Intended for Occupational Use (Non-WPS)
Restricted Use Pesticide
Statements for the 42%
Flowableand 11. 6% EC
Products (EPA Reg. Nos.
11556-98 and 11556-23)
Use Restriction Statement
for the 42% Flowable
Product (EPA Reg. No.
11556-98)
"RESTRICTED USE PESTICIDE: Due to Acute Oral Hazard-
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"
"Use restricted to employees of the U.S. Department of Agriculture Animal and Plant
Health Inspection Service (USDA-APFflS) who are enrolled in the USDA-APfflS
cholinesterase monitoring program."
Top of Front Panel
Front panel,
immediately following
the Restricted Use
Pesticide statement
37
-------
Table 8: Summary of Labeling Changes for Coumaphos
Description
Amended Labeling Language
Placement on Label
Handler PPE Requirements
for the 42% Flowable
Product (EPA Reg. No.
11556-98)
"Some materials that are chemical-resistant to this products 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 H] "on an EPA chemical-resistance
category selection chart."
"Mixers, loaders, and others exposed to the concentrate (such as during a spill or
equipment breakdown) and all other handlers participating in dip-vat applications must
wear:
*long-sleeve shirt and long pants,
*chemical-resistant gloves,
*chemical-resistant footwear plus socks,
*chemical-resistant apron, and
*face shield or goggles.
All other handlers, including spray applicators, must wear:
*long-sleeve shirt and long pants,
*chemical-resistant gloves, and
*chemical-resistant footwear plus socks."
Precautionary
Statement Directly
below the Hazards to
Humans and Domestic
Animals
38
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Table 8: Summary of Labeling Changes for Coumaphos
Description
Amended Labeling Language
Placement on Label
Handler PPE Requirements
for the 11.6% and 6.15%
Emulsifiable Concentrate
Products (EPA Reg. Nos.
11556-23 and 11556-115)
"Some materials that are chemical-resistant to this products 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 H] "on an EPA chemical-resistance
category selection chart."
"Mixers, loaders, and others exposed to the concentrate (such as during a spill or
equipment breakdown) must wear:
*long-sleeve shirt and long pants,
*chemical-resistant gloves,
*chemical-resistant footwear plus socks,
*chemical-resistant apron, and
*face shield or goggles.
Applicators and all other handlers exposed to the dilute must wear:
*long-sleeve shirt and long pants,
*chemical-resistant gloves, and
*chemical-resistant footwear plus socks."
Precautionary
Statement Directly
below the Hazards to
Humans and Domestic
Animals
39
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Table 8: Summary of Labeling Changes for Coumaphos
Description
Amended Labeling Language
Placement on Label
Handler PPE Requirements
for all Bulk Dust Products
"Some materials that are chemical-resistant to this products 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 H] "on an EPA chemical-resistance
category selection chart."
"Loaders, applicators and other handlers must wear:
*long sleeve shirt and long pants,
*chemical-resistant gloves,
* shoes plus socks,
*chemical-resistant apron,
*a NIOSH-approved dust/mist respirator, with MSHA/NIOSH approval number prefix
TC21C or a NIOSH-approved respirator with any N* R, P, or HE filter"
Precautionary
Statements Directly
below the Hazards to
Humans and Domestic
Animals
Handler PPE Requirements
for all Ready-to-Use Dust
Products
"Some materials that are chemical-resistant to this products 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 H] "on an EPA chemical-resistance
category selection chart."
"Applicators and other handlers must wear:
*long sleeve shirt and long pants,
*chemical-resistant gloves,
* shoes plus socks,
*chemical-resistant apron,
*a NIOSH-approved dust/mist respirator, with MSHA/NIOSH approval number prefix
TC21C or a NIOSH-approved respirator with any N* R, P, or HE filter"
Precautionary
Statements Directly
below the Hazards to
Humans and Domestic
Animals
40
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Table 8: Summary of Labeling Changes for Coumaphos
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 the
other laundry."
Precautionary
Statements Directly
below the PPE
Engineering Controls or
Improved Packaging for all
Liquid Products
EPA requires that all liquid concentrate formulations be contained in "no-glug" containers,
water-soluble gel packs, or other equivalent methods approved by the Agency.
Not for placement on
label
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing 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 Directly
below the User Safety
Requirements (must be
placed in a box)
Environmental Hazards
"This pesticide is toxic to mammals, birds, fish and aquatic invertebrates.
Coumaphos washed off of wading treated livestock may be hazardous to aquatic
organisms.
Do not contaminate water when disposing of equipment washwater or rinsate."
Precautionary
Statements under
Environmental Hazards
41
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Table 8: Summary of Labeling Changes for Coumaphos
Description
Amended Labeling Language
Placement on Label
Disposal Restriction
Statement for the 42%
Flowable Product (EPA
Reg. No. 11556-98)
"Cattle Dip Solution Disposal: The Agency requires that spent dip-vat solution be
bioremediated, and recommends the bioremediation method developed by the USDA. The
treated solution must be transferred to shallow, concrete-lined evaporation ponds for further
degradation. The evaporation ponds must be constructed to prevent overflow or flooding
during wet seasons and must be lined with reinforced concrete. Dried sludge generated in
the evaporation ponds must not be applied to agricultural land and should be disposed
according to solid waste disposal regulations established by your Local and/or State
Environmental Control Agency. Questions concerning the disposal of the spent solution
should be directed to the waste representative at the nearest EPA Regional Office."
Directions for Use
under Storage and
Disposal
Re-entry Restriction for
Liquid Products
"Entry Restrictions: Do not contact or allow others to contact treated animals until their
coats are dry."
Directions for Use
under General
Precautions and
Restrictions
Re-Entry Restriction for
Dust Products
"Entry Restrictions: Do not enter treated areas or allow contact with treated animals until
dusts have settled."
Directions for Use
under General
Precautions and
Restrictions
42
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Table 8: Summary of Labeling Changes for Coumaphos
Description
Application Restriction for
all Liquid Products
Application Restriction for
all Liquid and Dust
Products
Application Restriction for
all Products
Application Restriction for
Products Applied by Hand
Held Sprayer
Application Restriction for
all Dust Products
Application Restriction for
all Dust Products
Application Restrictions
Use Deletion for all Dust
Products
Amended Labeling Language
"Do not spray in a confined, non-ventilated area."
"Do not treat areas such as drinking cups, mangers, or troughs where livestock feed.
Do not contaminate water, food, feedstuffs, food or feed handling equipment, or milk or
meat handling equipment."
"Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may in the area during application."
"Individuals must limit the number of animals they treat per day with hand held sprayers to
no more than 100, if the animals are treated at the maximum label rate, 200 if they are
treated at 1A maximum label rate, etc."
"Individuals must limit the number of animals they can treat per day with shaker can to no
more than 25 and the area of swine bedding they can treat per day to 1,000 sq. ft."
"The use of mechanical dusters is prohibited."
Move the Application Restrictions section to the beginning of the Directions for Use section
The use of mechanical dusters are no longer supported by the technical registrant and will
be deleted from all dust products.
Placement on Label
Directions for Use
under Application
Restrictions
Directions for Use
under Application
Restrictions
Directions for Use
under Application
Restrictions
Directions for Use
under Application
Restrictions
Directions for Use
under Application
Restrictions
Directions for Use
under Application
Restrictions
Beginning of Directions
for Use
Not for placement on
label
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 Required section appearing in quotations represent the exact language that must appear on the label.
Instructions in the Labeling Required section not in quotes represents actions that the registrant must take to amend their labels or product registrations.
43
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VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM
This Reregistation Eligibility Decision Addendum is supported by documents that are presently
maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays
from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
September 2, 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 April 26, 2000.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op/."
44
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VII. APPENDICES
45
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Page Intentionally Blank
46
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Appendk A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
Site
Application Type
Formulation
%AI
Max. Single
Application
Rate
(Ib ai/gal)
Max.#
Apps
Restrictions/Comments
Food Uses
Beef and Non-Lactating Dairy Cattle
Dip vat treatment
Spray treatment
Spray treatment
Spray treatment
Backrubber treatment
Backrubber treatment
Dust bag treatment
4.2 Ib/gal
Flowable
4.2 Ib/gal
Flowable
1.0 Ib/gal
EC
0.5 Ib/gal
EC
1.0 Ib/gal
EC
0.5 Ib/gal
EC
1% ai bulk dust
0.025 Ib/gal
0.021 Ib/gal
0.029 Ib/gal
0.02 Ib/gal
0.076 Ib/gal
fuel oil
0.038 Ib/gal
fuel oil
N/A
2/year
6/year
Not
specified
6/year
Not
specified
Not
specified
Not
specified
Use of this formulation is restricted
to USDA- APHIS staff enrolled in
the USDA-APHIS Cholmesterase
Monitoring Program. Animals
should not be dipped more than
twice per year unless additional
treatments are required by APHIS
Veterinary Services
Regulations/Memoranda for Animal;
included in the Federal Eradication
Programs.
Individuals must limit the number of
animals they treat per day with hanc
held sprayers to no more than 1 00, i]
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hanc
held sprayers to no more than 1 00, i]
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hanc
held sprayers to no more than 1 00, i]
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
47
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Site
Application Type
Shakercan treatment
Shakercan treatment
Formulation
%AI
1% ai bulk dust
1% ai shaker can
Max. Single
Application
Rate
(Ib ai/gal)
0.0013 Ib
ai/animal
0.0013 Ib
ai/animal
Max.#
Apps
12/year
12/year
Restrictions/Comments
Individuals must limit the number of
animals they may treat with shaker
can to no more than 25 head per day
Individuals must limit the number of
animals they may treat with shaker
can to no more than 25 head per day
Lactating Dairy Cattle
Spray treatment
Spray treatment
Dust bag treatment
l.Olb/gal
EC
0.5 Ib/gal
EC
l%ai bulk dust
0.00241b/gal
0.01 Ib/gal
N/A
Not
specified
6/year
Not
specified
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, il
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
48
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Site
Application Type
Formulation
%AI
Max. Single
Application
Rate
(Ib ai/gal)
Max.#
Apps
Restrictions/Comments
Horses
Spray treatment
Spray treatment
Spray treatment
4.2 Ib/gal
Flowable
l.Olb/gal
EC
0.5 Ib/gal
EC
0.021 Ib/gal
0.029 Ib/gal
0.02 Ib/gal
6/year
Not
specified
6/year
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
49
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Site
Application Type
Formulation
%AI
Max. Single
Application
Rate
(Ib ai/gal)
Max.#
Apps
Restrictions/Comments
Swine
Spray treatment
Spray treatment
Shaker can treatment
Bedding treatment
Shakercan treatment
l.Olb/gal
EC
0.5 Ib/gal
EC
l%ai bulk dust
1% ai bulk dust
1% ai shaker can
0.005 Ib/gal
0.005 Ib/gal
0.000625 Ib
ai/animal
0.042 Ib
ai/lOOOsq.
ft.
0.000625 Ib
ai/animal
Not
specified
6/year
6/year
6/year
6/year
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they treat per day with hand
held sprayers to no more than 1 00, if
the animals are treated at the
maximum application label rate, 200
if they are treated at 1A maximum
label rate, etc.
Individuals must limit the number of
animals they may treat with shaker
can to no more than 25 head per day
Individuals must limit the number of
animals they can treat per day with
shaker can to no more than 1 ,000 sc
ft per day.
Individuals must limit the number of
animals they may treat with shaker
can to no more than 25 head per day
50
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Appendix B. DATA SUPPORTING GUIDELINE REQUIREMENTS FOR THE
REREGISTRATION OF COUMAPHOS
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within case #0018 (coumaphos) covered by this RED Addendum. It contains generic data
requirements that apply to coumaphos in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidance, which are available from
the National technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 (703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use
patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has
been assigned. Refer to the Bibliography appendix for a complete citation of the study.
51
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Page Intentionally Blank
52
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REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
New Guideline Old
Number Guideline
Number
830.1600
830.1670
830.1700
830.7370
830.7550
830.6313
61-2A
61-2B
62-1
63-10
63-11
63-13
ECOLOGICAL
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Dissociation Constant
Octanol/Water Partition
Coefficient
Stability
EFFECTS
850.2500 71-5B Actual Field Study
None 72-4A Fish-Early Life Stage
None 72-4B Estuarine/Marine Invertebrate
Life Cycle
TOXICOLOGY
870.3200 82-2 21-Day Dermal - Rabbit/Rat
None 82-5(b) 90-Day Neurotox-Mammal
All 41117401, 41117403, 41778502, 42378501
All 41117401, 41117403, 41778502, 42378501
All 42258601, 42675001, 42675003
All Waived
All 41778501
All 41778502
N/A Waived, 42512603, 42512604
A 43066301
A 43116601
L 42084901, 42666401, 44749401
All 44775901
53
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REQUIREMENT
USE PATTERN CITATION(S)
870.4100 83-1B Chronic Feeding Toxicity -
Non-Rodent
870.3800 83-4 2-Generation Reproduction -
Rat
870.5375 84-2B Structural Chromosomal
Aberration
ENVIRONMENTAL FATE
835.2120 161-1 Hydrolysis
835.2240 161-2 Photodegradation - Water
835.2410 161-3 Photodegradation - Soil
835.4400 162-3 Anaerobic Aquatic Metabolism
835.1240 163-1 Leaching/Adsorption/Desorptio
n
None 166-3 Ground Water-Irrigation
Retrospe
RESIDUE CHEMISTRY
860.1300 171-4B Nature of Residue - Livestock
171-4D
860.1340
860.1380
171-4E
Residue Analytical Method -
Animals
Storage Stability
43055301
43061701
41847501, 42254501
A 00263038
A 42764101, 43022101, 43103901
N/A 42920301,43167401
A Waived
A 42084901,42097401
N/A N/A
A 42097402,42323402
A 42097403, 42323401, 43123401
A 43569801, 43569802, 43569803, 43569804,
43569805, 43569806, 43569807, 43569808,
43569809, 43569810
54
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REQUIREMENT
USE PATTERN CITATION(S)
860.1480 171-4J Magnitude of Residues -
Meat/Milk/Poultry
/Egg
N/A
N/A
OTHER
None 231
None 232
Estimation of Dermal Exposure
Estimation of Inhalation
Exposure
None 70-1-SS Aquatic Monitoring
None 81-8-SS Acute Neurotox
870-6200 81-8 Neurotox Scrn Batt-Acu
870-6200 82-7 Neurotox Scrn Batt-Sub
870-6300 None Developmental Neurotox
A
A
All
A
A
A
Waived
Waived
42512601, 42512602
44544801
44544801
44775901
Data Gap
55
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Page Intentionally Blank
56
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Appendk C. LIST OF AVAILABLE RELATED DOCUMENTS
These documents are available from the Public Docket Office or at the following web site:
www.epa.gov/pesticides/op/coumaphos.htm
5) Hazard Assessment of the Organophosphates
6) FQPA Safety Factor Recommendations for the Organophosphates
7) Frequently Asked Questions
8) Federal Register Notice Vol. 65, Number 81, Pages 24468-24469 (Comment period ending
June 26, 2000)
9) Federal Register Notice Vol. 64, Number 170, Pages 48164-48165 (Comment period
ending November 1, 1999)
10) Transmittal Letter to Bayer Corporation Regarding the Preliminary Risk Assessment
11) Preliminary Dietary and Occupational Risk Assessment
12) Revised Dietary and Occupational Risk Assessment
13) Preliminary Acute and Chronic Dietary Exposure and Risk Analyses
14) Addendum to the Acute and Chronic Dietary Exposure and Risk Analysis
15) Revised Acute and Chronic Dietary Exposure and Risk Analyses
16) Addendum to the Acute Dietary Exposure Analysis for Coumaphos
17) Preliminary Occupational Exposure and Risk Assessment
18) Revised Occupational Exposure and Risk Assessment
19) Addendum to the Occupational Exposure and Risk Assessment
20) Tier 1 Drinking Water Assessment for Land Farming of Bioremediated Coumaphos from Cattle
Dips
21) Revised Tier 1 Drinking Water Assessment for Coumaphos
22) Report of the FQPA Safety Factor Committee
23) Report of the Hazard Identification Assessment Review Committee
24) Percent Dairy Cattle Treated with Coumaphos
25) Quantitative Usage Analysis for Coumaphos
26) Coumaphos Summary
27) Overview of Coumaphos Revised Risk Assessments
28) Registrant's Response to EPA's Letter Transmitting the Preliminary Risk Assessment
29) EPA's Response to the Registrant's Error Comments
30) HED's Response to Public Comments
31) EPA's Response to Public Comments
57
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Page Intentionally Blank
58
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Appendix D. CITATIONS SUPPORTING THE REREGISTRATION ELIGIBILITY
DECISION ADDENDUM AND FQPA TOLERANCE REASSESSMENT
PROGRESS REPORT (BIBLIOGRAPHY)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This 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 for studies in this bibliography have been
the body of data submitted to EPA and its predecessor agencies in support of past 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, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger 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 the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the
review may be preceded by a nine character temporary 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 the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA, by
a description of the 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 the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
59
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b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (1999), the Agency
was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a 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 following 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.
60
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BIBLIOGRAPHY
MRID CITATION
00110597 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for Coumaphos
Compound: Report No. 72212. (Unpublished study received on unknown date under
11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-B)
00110598 Shmidl, I; Kohlenberg, M.; Rainey, L. (1981) Dermal LD50 Evaluation for
Coumaphos Technical Compound: Report No. 72216. (Unpublished study received
on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission, KS;
CDL:248200-C)
00110599 Shmidl, I; Kohlenberg, M.; Rainey, L. (1981) Eye Irritation Evaluation for Coumaphos
Technical in Rabbits: Report No. 72213. (Unpublished study received on unknown
date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-D)
00110600 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Primary Dermal Irritancy of Coumaphos
Technical to Rabbits: Report No. 72205. (Unpublished study received on unknown
date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-E)
00110601 Sangha, G.; De Jong, M.; Lamb, D.; et al. (1982) Acute Inhalation Toxicity Study with
Coumaphos Technical in Rats: Study No. 81-041-14, Report No. 72398.
(Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-F)
00110602 Shmidl, J.; Kohlenberg, M.; Hess, L. (1982) Dermal Sensitization Evaluation of
Coumaphos Technical in Guinea Pigs: Report No. 72452. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-G)
00115167 Kruckenberg, S. (1981) Acute Delayed Neurotoxicity of Coumaphos in
Hens~81-Chicken-02: [Submitter] 72206. (Unpublished study received Sep 23,
1982 under 11556-11; prepared by Kansas State Univ., Veterinary Medical Center,
Dept. of Pathology, submitted by Bayvet, Shawnee Mission, KS; CDL:248397-A)
00126527 Porter, M.; Jasty, V.; Bare, J.; et al. (1983) Subchronic (13 Week) Oral Toxicity
Evaluation of Coumaphos in the Rat: Bayvet Report No. 72586. (Unpublished study
received Mar 21, 1983 under 11556-11; prepared in cooperation with Miles
Laboratories, submitted by Bayvet, Shawnee Mission, KS; CDL:249746-A)
61
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BIBLIOGRAPHY
MRID CITATION
00131684 Clemens, G.; Hartnagel, R. (1983) Study of the Toxicity of Coumaphos: m. Teratology
(Segment H) Study in the Rat: Report No. 8; 72754. (Unpublished study received Oct
18, 1983 under 11556-11; prepared by Mies Laboratories, Inc., submitted by Bayvet,
Shawnee Mission, KS; CDL:251532-E)
00159928 Waggoner, T. (1986) Hydrolysis of ?Carbon 14* Coumaphos in Sterile Buffered
Aqueous Solutions: Report No. 73320. Unpublished study prepared by Pharmacology
and Toxicology Research Laboratory. 118 p.
263038 See MRID #159928
41117401 Shoup, R. (1989) Rabon Oral Larvicide Manufacturing Base: Product Identity and
Composition. Unpublished study prepared by Fermenta Animal Health Co. 16 p.
41117403 Shoup, R. (1989) 75% Rabon Insecticide Wettable Powder: Product Identity and
Composition. Unpublished study prepared by Fermenta Animal Health Co. 16 p.
41778501 Rose, W. (1990) Co-Ral 25% Dust Base (Coumaphos): Lab Project Number: 74114;
74115. Unpublished study prepared by Mobay Corp. 77 p.
41778502 Rose, W. (1990) Product Chemistry of Coumaphos Technical Grade 1: Lab Project
Number: 74111; 74113; 72899. Unpublished study prepared by Mobay Corporation.
98 p.
41847501 Putman, D. (1991) Micronucleus Cytogenetic Assay in Mice: Coumaphos Technical:
Lab Project Number: T9423/122. Unpublished study prepared by Microbiological
Associates, Inc. 36 p.
42084901 Sheets, L.; Phillips, S. (1991) Repeated Dose (21-Day) Dermal Toxicity Study with
Technical Grade Coumaphos in Rats: Lab Project Number: 91-122-IE. Unpublished
study prepared by Mobay Corp. 253 p.
42097401 Waggoner, T. (1991) Coumaphos: Adsorption/Desorption of Two Degradation
Products: Chlorferon andHOL-5461: Lab Project Number: COUM91E: COUM91D.
Unpublished study prepared by M. C. Bownam and Associates. 101 p.
42097402 Waggoner, T. (1991) Coumaphos: Nature of the Residue: Lab Project Number:
9014B. Unpublished study prepared by Southwest Bio-Labs, Inc. 138 p.
62
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BIBLIOGRAPHY
MRID CITATION
42097403 Waggoner, T. (1991) Coumaphos: Residue Analytical Methods: Lab Project Number:
MOB AY-MR-1: MOBAY-MR-1 A. Unpublished study prepared by M. C. Bowman
and Associates. 86 p.
42254501 Goethem, D. (1992) Micronucleus Cytogenetic Assay in Mice: Lab Project Number:
T9423.122. Unpublished study prepared by Microbiological Associates, Inc. 9 p.
4225 8601 Basel, C. (1992) Analysis of Five Lots of Co-Ral 25 Percent Dust Base and Five Lots
of Coumaphos Technical: Lab Project Number: 92-624-009... 127. Unpublished study
prepared by Miles, Inc. 29 p.
42323401 Waggoner, T. (1992) Coumaphos: Residue Chemistry: Residue Analytical Methods:
Lab Project Number: COUM91H: COUM91H1. Unpublished study prepared by
M.C. Bowman and Associates and Miles, Inc. 74 p.
42323402 Waggoner, T. (1992) Coumaphos: Residue Chemistry: Nature of the Residue: Lab
Project Number: 74311: COUM92E. Unpublished study prepared by M.C. Bowman
and Associates and Miles, Inc. 29 p.
42378501 Brannan, C. (1992) Supplemental Submission to MRID No. 417785-01: Product
Identity and Composition of Coumaphos Technical Grade 1. Unpublished study
prepared by Miles Inc. 10 p.
42378502 Thomas, L. (1992) Progress Report on the Identification of Substances Associated
with Coumaphos in Co-Ral 25% Dust Base/Wettable Powder and Coumaphos
Technical: Lab Project Number: 92-618-016: 92-618-023: 92-619-035. Unpublished
study prepared by Miles Inc. 25 p.
42512601 Judy, D.; Kaiser, F. (1992) Removal of Coumaphos Active Ingredient from Cattle
Hides Treated with Co-Ral Emulsifiable Liquid Insecticide (E.L.I.): Lab Project
Number: 40329. Unpublished study prepared by ABC Labs, Inc. 117 p.
42512602 Judy, D.; Kaiser, F. (1992) Removal of Coumaphos Active Ingredient from Cattle
Hides Treated with Co-Ral 25% Wettable Powder Insecticide: Lab Project Number:
40418. Unpublished study prepared by ABC Labs, Inc. 112 p.
42512603 Shmidl, J. (1992) Coumaphos: Field Testing—Birds. Unpublished study prepared by
Cornell Lab of Ornithology. 52 p.
63
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BIBLIOGRAPHY
MRID CITATION
42512604 Corn, L; Nettles, V. (1992) Coumaphos: Pilot Field Study to Evaluate Potential
Toxicologic Effects in Wild Birds by Coumaphos Applications to Livestock: Lab
Project Number: SCWDS-001. Unpublished study prepared by The Univ. of
Georgia. 51 p.
42666401 Astroff, A. (1993) Repeated Dose (21 Day) Dermal Toxicity Study with Technical
Grade Coumaphos in Rats: Supplemental To MRID 42084901: Lab Project Number:
91-122-IE. Unpublished study prepared by Miles Inc. 20 p.
42675001 Basel, C. (1993) Identification of Three HPLC Peaks of Unknown Impurities
Associated with Coumaphos: Lab Project Number: 93-633-107: 74386. Unpublished
study prepared by Bayer AG. 30 p.
42675003 Thomas, L. (1993) Analysis of 5 Lots of Co-Ral 25% Dust Base and 5 Lots of
Coumaphos Technical: Revised Report: Lab Project Number: 92-624-009:
92-619-035: 74284. Unpublished study prepared by Miles Inc. 40 p.
42764101 Dykes, J. (1993) Determination of the Aqueous Photodegradation of (carbon
14)-Coumaphos: Revised Final Report: Lab Project Number: 1224: 1224-1: 74413.
Unpublished study prepared by Analytical Development Corp. 81 p.
42764102 Dykes, J. (1993) Determination of the Aqueous Photodegradation of (carbon
14)-Coumaphos: Addendum No. 1 to Revised Final Report: Lab Project Number:
1224: 1-1224: 74413-1. Unpublished study prepared by Analytical Development
Corp. 9 p.
42920301 Dykes, J. (1993) Determination of the Photodegradation of (14-C) Coumaphos on the
Surface of Soil: Lab Project Number: ADC 1223. Unpublished study prepared by
Analytical Development Corporation. 82 p.
43022101 Kelley, I; Wood, S. (1993) Aqueous Photolysis of Coumaphos-Identification of the
Main Degradate: A Study to Supplement Miles Report 74413: Lab Project Number:
106221: CS082401. Unpublished study prepared by Miles Inc. Agricultural Div. 43
P-
43055301 Jones, R; Elcock, L.; Dass, P.; et al. (1993) Chronic Feeding Toxicity Study of
Technical Grade Coumaphos in Beagle Dogs: Lab Project Number: 91-276-JP:
74459. Unpublished study prepared by Miles, Inc. 1487 p.
64
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BIBLIOGRAPHY
MRID CITATION
43061701 Eigenberg, D.; Elcock, L. (1993) A Two-generation Dietary Reproduction Study in
Rats Using Technical Grade Coumaphos: Lab Project Number: 91-672-JI: 74460.
Unpublished study prepared by Miles, Inc. 1044 p.
43066301 Gagliano, G.; Bowers, L. (1993) Early Life Stage Toxicity of
(carbon-14)-Coumaphos to the Rainbow Trout (Oncorhynchus mykiss) Under
Flow-Through Conditions: Lab Project Number: 106245: CS842201. Unpublished
study prepared by Miles Inc. 70 p.
43103901 Kelley, L; Wood, S. (1994) Aqueous Photolysis of Coumaphos-Identification of the
Main Degradate: Lab Project Number: CS082401: 106221. Unpublished study
prepared by Miles Agricultural Division. 43 p.
43115801 Siemann, L. (1993) Product Chemistry for Coumaphos: Lab Project Number: 74462:
3537-F. Unpublished study prepared by Midwest Research Institute. 29 p.
43116601 Gagliano, G.; Fuss, M. (1994) Chronic Toxicity of (carbon 14)-Coumaphos to
Daphnia magna Under Static Renewal Conditions: Lab Project Number: CS840701:
106410. Unpublished study prepared by Miles, Inc. 57 p.
43123401 Bajzik, M. (1994) The Independent Laboratory Method Validation for the Analysis of
Coumaphos and its Oxygen Analog in Meat and Milk: Lab Project Number:
A012.005: 74473. Unpublished study prepared by Huntingdon Analytical Services.
102 p.
43167401 Dykes, J. (1994) Determination of the Photodegradation of (carbon 14)-Coumaphos
on the Surface of Soil: Characterization of Bound Residues and Radioactivity Loss:
Revision #1 to Final Research Report: Lab Project Number: 1223H-1: 74476.
Unpublished study prepared by Analytical Development Corp. 33 p.
43569801 Fought, L. (1994) Coumaphos Residues in Cattle Treated with CO-RAL 25%
Wettable Powder: Revised: Lab Project Number: 10820: KC-212-62D. Unpublished
study prepared by Miles, Inc. 7 p.
43569802 Fought, L. (1994) Coumaphos Residues in Cattle Exposed to a Backrubber Prepared
from CO-RAL Emulsifiable Livestock Insecticide: Revised: Lab Project Number:
13912: KC-201-64D. Unpublished study prepared by Miles, Inc. 9 p.
65
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BIBLIOGRAPHY
MRID CITATION
43569803 Fought, L. (1994) Coumaphos Residues in the Milk of Cattle Treated with CO-RAL
Emulsifiable Livestock Insecticide: Revised: Lab Project Number: 24050:
KC-200-68D. Unpublished study prepared by Miles, Inc. 45 p.
43569804 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
Emulsifiable Livestock Insecticide: Revised: Lab Project Number: 26083. Unpublished
study prepared by Miles, Inc. 13 p.
43569805 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
25% Wettable Powder: Revised: Lab Project Number: 26084. Unpublished study
prepared by Miles, Inc. 13 p.
43569806 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
Insecticide Pour-On: Revised: Lab Project Number: 26107. Unpublished study
prepared by Miles, Inc. 13 p.
43569807 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
25% Wettable Powder: Revised: Lab Project Number: 27484: AH-70A-743.
Unpublished study prepared by Miles, Inc. 20 p.
43569808 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
Insecticide Pour-On: Revised: Lab Project Number: 27486: AH-70A-749.
Unpublished study prepared by Miles, Inc. 13 p.
43569809 Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Dipped in a 50%
Formulation of CO-RAL Wettable Powder: Revised: Lab Project Number: 40856:
AH-74A-932. Unpublished study prepared by Miles, Inc. 25 p.
43569810 Fought, L. (1994) Coumaphos Residues in the Tissues of Cattle Treated with a 3%
Formulation of K.R.S. with CO-RAL Spray Foam Insecticide: Revised: Lab Project
Number: 50836: TR-76A-116. Unpublished study prepared by Miles, Inc. 31 p.
44252901 Niven, KJM et al. (1993) Occupational Hygiene Assessment of Sheep Dipping
Practices and Processes.
44252902 Niven, KJM et al. (1996) Occupational Hygiene Assessment of Exposure to
Insecticide and the Effectiveness of Protective Clothing During Sheep Dipping
Operations.
66
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BIBLIOGRAPHY
MRID CITATION
44296901 Lunchick, C. (1997) Reassessment of Operator Exposure and Risk for the Animal
Spray and Dip Uses of Coumaphos: Lab Project Number: 74852. Unpublished study
prepared by Jellinek, Schwartz & Connolly, Inc. 94 p.
44518501 Merricks, D. (1998) Carbaryl Mixer/Loader/Applicator Exposure Study During
Application of RP-2 Liquid (21%) to Fruit Trees and Ornamental Plants: Lab Project
Number: 1518. Unpublished study prepared by Agrisearch Inc., Rhone-Poulenc Ag
Co., and Morse Laboratories, Inc. 320 p.
44544801 Dreist, M.; Popp, A. (1998) Acute Oral Neurotoxicity Screening Study in Wistar Rats:
Coumaphos: Lab Project Number: PH-27054: T 4061287: 74961. Unpublished study
prepared by Bayer AG. 441 p.
44749401 Sheets, L.; Gastner, M. (1999) Repeated-Dose (Two-and Five-Day Exposure)
Dermal Toxicity Study with Technical Grade Coumaphos in Rats: Lab Project Number:
97-122-NT. Unpublished study prepared by Bayer Corporation. 48 p.
44775901 Dreist, M.; Popp, A. (1998) Coumaphos: Subchronic Neurotoxicity Screening Study in
Wistar Rats (Thirteen Week Administration in the Diet): Lab Project Number:
PH-28342: T 3061060: 75026. Unpublished study prepared by Bayer Ag. 485 p.
44972201 Klonne, D. (1999) Integrated Report for Evaluation of Potential Exposures to
Homeowners and Professional Lawn Care Operators Mixing, Loading, and Applying
Granular and Liquid Pesticides to Residential Lawns: Lab Project Number: OMAOO5:
OMAOO1: OMAOO2. Unpublished study prepared by Ricerca, Inc., and Morse
Laboratories. 2213 p.
45129601 Mihlan, G. J. (2000) Reassessment of Operator Exposure and Risk for the Uses of
Coumaphos. Bayer Report No. 75217. Unpublished study prepared by Bayer
Corporation. 28 p.
67
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BIBLIOGRAPHY
CITATION
The following studies do not have MRID Numbers:
Kurta, D.A. and W.M. Bode. (1985). Applicator Exposure to the Home Gardener.
American Chemical Society Symposium Series 273, Washington, DC.
Livestock Spraying Practices Survey. (1996). Bayer Animal Health. Vance
Publishing. Attachment of MRID 44296901.
68
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Appendix E. LIST OF REGISTRANTS
Technical Registrant: Bayer Corporation, Agriculture Division, Animal Health
Contact: F. Terry McNamara
Address: Bayer Corporation
P.O. Box 390
Shawnee Mission, KS 66201-0390
Telephone Number: (913) 631 -4800
69
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