United States Prevention, Pesticides EPA 738-R-04-005
Environmental Protection And Toxic Substances March 2004
Agency (7508C)
Interim Reregistration
Decision (IRED)
Dicrotophos
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA 738-F-02-006
May, 2002
SERA Dicrotophos Facts
EPA has assessed the risks of dicrotophos and reached an Interim Reregistration Eligibility
Decision (IRED) for this organophosphate (OP) pesticide. Provided that risk mitigation measures are
adopted, dicrotophos' individual, aggregate risks are within acceptable levels based on assessed
benefits of use. Dicrotophos also is eligible for reregistration, once cumulative risks are considered.
EPA's next step is to consider the cumulative
risks of the OP pesticides, which share a common
mechanism of toxicity. The interim decision on
dicrotophos will not be final until these cumulative
risks also are considered. Further risk mitigation may
be warranted at that time.
Used on cotton and as a tree injection
treatment on non food bearing trees, dicrotophos use
does not result in risk concerns from residues in food
and drinking water. Low concentrations of
dicrotophos have been detected in surface waters,
but total dietary risk is at acceptable levels. Although
dicrotophos can be used as a tree injection treatment
around residential areas, the treatment should not
result in significant exposures to children and others.
Without further mitigation limiting children's and
others' exposure through food, and drinking water,
dicrotophos fits into its own "risk cup". With other
mitigation measures, dicrotophos's worker and
ecological risks will still be above levels of concern,
but the risks are balanced by strong benefits of
dicrotophos to cotton production.
The OP Pilot Public Participation Procss
The organophosphates (OPs) are a group
of related pesticides that affect the functioning of
the nervous system. They are among EPA's
highest priority for review in implementing provisions
of the Food Quality Protection Act (FQPA) of
1996.
EPA encourages the public to participate
in the review of the OP pesticides. Through a six-
phased pilot public participation process, the
Agency has released for review and comment its
preliminary and revised scientific risk assessments
for individual OPs. (Please contact the OP Docket,
telephone 703-305-5805, or see EPA's web site,
www.epa.gov/pesticides/op.)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides. The Agency will make
final decisions after considering the cumulative
risks of the OPs. (Please see
www.epa.Qov/pesticides/cumulative.htm.l
EPA is reviewing the OP pesticides to
determine whether they meet current health and safety
standards. Older OPs require decisions about their eligibility for reregistration under FIFRA. OPs
with food, drinking water, residential, and any other non-occupational exposures must be reassessed to
make sure they meet the new FFDCA safety standard, effected by the Food Quality Protection Act
(FQPA) of 1996.
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The dicrotophos interim decision was made through the OP pilot public participation process,
which increases transparency and maximizes stakeholder involvement in EPA's development of risk
assessments and risk management decisions. EPA worked extensively with affected parties to reach
the decisions presented in this interim decision document.
Uses
Dicrotophos is used as an insecticide to control flea hoppers, aphids, thrips, stink bugs and
plantbugs in cotton. Dicrotophos can also be applied by tree injection to control insects on
ornamental and non food bearing trees.
Annual domestic use is approximately 550,000 pounds of active ingredient per year. The bulk
of this use is on cotton in the southeast, Texas, and Arkanssas. Dicrotophos is not registered
for use in California and Arizona.
Health Effects
Dicrotophos can cause cholinesterase inhibition in humans; that is, it can overstimulate the
nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g., accidents
or major spills), respiratory paralysis and death. Dicrotophos causes cholinesterase inhibition at
very low concentrations and this inhibition can last for up to two weeks from a single exposure.
Risks
Dietary Risks: Exposures to dicrotophos from food alone are well within acceptable levels
for all populations. Dietary exposures from water assessed from screening level modeling
concentrations are within acceptable ranges. Extremely limited monitoring data are in the same
order of magnitude as modeled concentrations. Dicrotophos residues were frequently detected
at low levels in the monitoring studies where samples were analyzed for dicrotophos.
A tolerance has been established for cotton seed and a tolerance for cotton gin by-products has
been proposed.
Worker Risks: EPA has risk concerns for workers who mix, load, and/or apply
dicrotophos to cotton. Because of the high toxicity of dicrotophos, small amounts of exposure
will result in high levels of risk, Applicators and handlers have high risk from potential exposure
during mixing, loading and applying aerial applications of dicrotophos. The highest single
application rate for ground applications also results in risks which are of concern to the EPA;
however, this rate is considered to be necessary for adequate pest control.
Workers may enter the fields without additional protective clothing 6 days after application.
Exceptions to this 6 day re-entry interval can be made for scouts who do not spend long
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periods of time in the treated fields and for workers who are doing "low contact activities" such
as mechanical cultivating and spraying.
• Wildlife Risks: Wildlife concerns for dicrotophos are mainly for birds and mammals. While
dicrotophos may be expected to be found at low levels in surface water, dicrotophos is not as
toxic to fish and aquatic invertebrates as other OPs.
Dicrotophos was shown to be acutely toxic to birds and mammals at very low concentrations.
In fact, any dicrotophos use may result in exposures that could acutely impact individual birds
or small mammals. On a chronic basis, dicrotophos has been shown to have reproductive
effects on birds causing reduced egg production, embryo viability, hatchling production and
survival, and eggshell thickness.
Beneficial insects may also be affected by use of dicrotophos.
Risk Mitigation
To reduce risks to workers and to wildlife, the following mitigation measures are required.
To mitigate risks to agricultural workers:
• closed systems are required for mixing and loading dicrotophos
• aerial applications are prohibited after January, 2005
re-entry intervals are set at 6 days post-treatment
• To mitigate ecological risks:
• limit total seasonal use to 0.83 Ib ai/A
• limit total use prior to August 1 of any year to 0.5 Ib ai/A.
To limit all risks:
annual production is limited to the average amount produced in the years 1999-2001.
Next Steps
• Numerous opportunities for public comment were offered as this decision was being
developed. The dicrotophos IRED therefore is issued in final, without a formal public comment
period. (Please see www.epa.gov/pesticides/reregistration/status.htm or
www.epa.gov/pesticides/op). The docket remains open, however, and any comments
submitted in the future will be placed in this public docket.
• When EPA has considered the cumulative risks of the OP pesticides, the Agency will issue its
final tolerance reassessment decision for dicrotophos and may request further risk mitigation
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measures. For all OPs, tolerances will not be raised or established until cumulative risks have
been considered.
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g UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MAR 2 2 20M
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary and revised risk assessments for the organophosphate
pesticide dicrotophos. The public comment period on the revised risk assessment phase of the
reregistration process is closed. Based on comments received during the public comment period
and additional data received from the registrant, the Agency revised the human health and
environmental effects risk assessments and made them available to the public on January 10,
2000. This concluded Phase 4 of the OP Public Participation Pilot Process developed by the
Tolerance Reassessment Advisory Committee, and initiated Phase 5 of that process. During
Phase 5, all interested parties were invited to participate and provide comments and suggestions
on ways the Agency might mitigate the estimated risks presented in the revised risk assessments.
This public participation and comment period commenced on June 14, 2000, and closed on
August 14, 2000.
Based on its review, EPA has identified risk mitigation measures that the Agency believes
are necessary to address the human health and environmental risks associated with the current
use of dicrotophos. The EPA is now publishing its interim decision on the reregistration
eligibility of and risk management decision for the current uses of dicrotophos and its associated
human health and environmental risks. The reregistration eligibility and tolerance reassessment
decisions for dicrotophos will be finalized once the cumulative risks for all of the
organophosphate pesticides are considered. The enclosed "Interim Reregistration Eligibility
Decision for Dicrotophos," which was approved on April 3, 2002, contains the Agency's
decision on the individual chemical dicrotophos.
A Notice of Availability for this Interim Reregistration Eligibility Decision for dicrotophos
is being published in the Federal Register. To obtain a copy of the interim RED 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 interim RED and all supporting documents are available on the Internet. See
http:www.epa.gov/pesticides/op.
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The interim RED is based on the updated technical information found in the dicrotophos
public docket. The docket not only includes background information and comments on the
Agency's preliminary risk assessments, it also now includes the Agency's revised risk
assessments for dicrotophos (revised as of November 7, 2001), and a document summarizing the
Agency's Response to Comments. The Response to Comments document addresses corrections
to the preliminary risk assessments submitted by chemical registrants, as well as responds to
comments submitted by the general public and stakeholders during the comment period on the
risk assessment. The docket will also include comments on the revised risk assessment, and any
risk mitigation proposals submitted during Phase 5. Comments on mitigation or mitigation
suggestions were submitted by the American Bird Conservancy, the National Agricultural
Aviators Association, a private crop consultant and cotton grower from Louisiana, and Am vac
Chemical Company.
This document and the process used to develop it are the result of a pilot process to
facilitate greater public involvement and participation in the reregistration and/or tolerance
reassessment decisions for these pesticides. As part of the Agency's effort to involve the public
in the implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is
undertaking a special effort to maintain open public dockets 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.
Please note that the dicrotophos risk assessment and the attached interim RED concern
only this particular organophosphate. This interim RED presents the Agency's conclusions on
the dietary risks posed by exposure to dicrotophos alone. The Agency has also concluded its
assessment of the ecological and worker risks associated with the use of dicrotophos. 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 considering the risks for the individual organophosphates. The Agency is working towards
completion of a methodology to assess cumulative risk and the individual risk assessments for
each organophosphate are likely to be necessary elements of any cumulative assessment. The
Agency has decided to move forward with individual assessments and to identify mitigation
measures necessary to address those human health and environmental risks associated with the
current uses of dicrotophos. The Agency will issue the final tolerance reassessment decision for
dicrotophos and finalize decisions on reregistration eligibility once the cumulative risks for all of
the organophophates are considered.
This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
outline(s) further data requirements for this chemical. Note that a complete DCI, with all
pertinent instructions, is being sent to registrants under separate cover. Additionally, for
product-specific DCIs, the first set of required responses to is due 90 days from the receipt of the
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DCI letter. The second set of required responses is due eight months from the date of the DCI.
In this interim RED, the Agency has determined that dicrotophos 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 dicrotophos may pose unreasonable adverse effects to
human health and the environment, and that such effects can be mitigated with the risk
mitigation measures identified in this interim RED. Accordingly, the Agency recommends that
registrants implement these risk mitigation measures immediately. Sections IV and V of this
interim RED describe labeling amendments for end-use products and data requirements
necessary to implement these mitigation measures. Instructions for registrants on submitting the
revised labeling can be found in the set of instructions for product-specific data that accompanies
this interim RED.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by dicrotophos.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern. At that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregistration,
please contact the Chemical Review Manager, Laura Parsons at (703) 305-5776. For questions
about product reregistration and/or the Product DCI that accompanies this document, please
contact the Product Reregistration Manager, Karen Jones at (703) 308-8047.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Interim Reregistration Eligibility Decision
for
Dicrotophos
Case No. 0145
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TABLE OF CONTENTS
Executive Summary 1
I. Introduction 3
II. Chemical Overview 5
A. Regulatory History 5
B. Chemical Identification 5
C. Use Profile 6
D. Estimated Usage of Pesticide 7
III. Summary of Dicrotophos Risk Assessment 8
A. Human Health Risk Assessment 8
1. Dietary Risk from Food 8
a. Toxicity 8
b. FQPA Safety Factor 8
c. Population Adjusted Dose (PAD) 9
d. Exposure Assumptions 10
e. Food Risk Characterization 10
2. Dietary Risk from Drinking Water 11
3. Occupational and Residential Risk 12
a. Toxicity 12
b. Exposure 14
c. Occupational Handler Risk Summary 15
i) Agricultural Handler Risk 15
ii) Post-Application Occupational Risk 17
iii) Residential (Homeowner) Handler Risk 18
B. Environmental Risk Assessment 18
1. Environmental Fate and Transport 18
2. Water resource assessment 19
a. Ground water 19
b. Surface Water 19
3. Toxicity (Hazard) Assessment 20
a. Avian/Mammalian Toxicity 20
b. Toxicity to Aquatic Animals 21
c. Toxicity to Plants 22
4. Exposure and Risk Calculations 22
a. Levels of Concern 22
b. Exposure and Risk to Nontarget Terrestrial Animals 23
i) Avian Risk 23
ii) Risks to Mammals 26
iii) Risk to Insects 28
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c. Exposure arid Risk to Nontarget Aquatic Animals 28
i) Risk to Fish 28
ii) Risk to Aquatic Invertebrates 29
d. Exposure and Risk to Nontarget Plants 29
5. Ecological Incidents 30
6. Endangered Species 30
7. Risk Characterization 31
IV. Interim Risk Management and Reregistration Decision 33
A. Determination of Interim Reregistration Eligibility 33
B. Summary of Phase 5 Comments and Responses 34
C. Regulatory Position 34
1. FQPA Assessment 34
a. "Risk Cup" Determination 34
b. Tolerance Summary 35
2. Endocrine Disrupter Effects 36
3. Labels 36
4. Mitigation for Agricultural Uses 36
D. Benefits Assessment Summary 36
E. Regulatory Rationale 37
1. Human Health Risk Mitigation 37
a. Dietary Mitigation 37
i) Dietary (Food) 37
ii) Drinking Water 37
b. Occupational Risk Mitigation 38
i) Agricultural Uses 38
ii) Post-Application Risk 38
2. Environmental Risk Mitigation 39
F. Other Labeling 39
1. Endangered Species Statement 39
2. Spray Drift Management 40
V. What Registrants Need to Do 41
A. Manufacturing Use Products 43
1. Additional Generic Data Requirements 43
2. Labeling for Manufacturing Use Products 43
B. End-Use Products 43
1. Additional Product-Specific Data Requirements 43
2. Labeling for End-Use Products 43
C. Existing Stocks 44
D. Labeling Changes Summary Table 45
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APPENDIX A. FOOD/FEED USE PATTERNS SUBJECT TO REREGISTRATION FOR
DICROTOPHOS 57
APPENDIX B. DATA SUPPORTING GUIDELINE REQUIREMENTS FOR THE
REREGISTRATION OF DICROTOPHOS 59
APPENDIX C. BIBLIOGRAPHY FOR DICROTOPHOS 63
APPENDIX D. GENERIC DATA CALL-IN 71
APPENDIX E. PRODUCT SPECIFIC DATA CALL-IN 79
APPENDIX F. LIST OF REGISTRANTS RECEIVING DATA CALL-INS 91
APPENDIX G. EPA'S BATCHING OF DICROTOPHOS PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 95
APPENDIX H. TECHNICAL SUPPORT DOCUMENTS 97
APPENDIX I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 99
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA 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.
D WLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities
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and other organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HDT Highest Dose Tested
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible: Intake
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect: Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
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
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PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Q, * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
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
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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Dicrotophos TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Rebecca Daiss
Sanju Diwan
Timothy Leighton
Gary Otakie
Environmental Risk Assessment
Nicholas Mastrota
Karen McCormack
Jim Carleton
Stephanie Syslo
Use and Usage Analysis
Alan Halvorson
William Gross
BillChism
Registration Support
Marilyn Mautz
Risk Management
Cletus Mixon
Michael Nieves
Laura Parsons
Amaris Johnson
John Leahy
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for dicrotophos. The decisions outlined in this document do not
include the final tolerance reassessment decision for dicrotophos; however, some tolerance actions will
be undertaken prior to completion of the final tolerance reassessment. A single tolerance for pecans
will be revoked now, because there are no currently registered uses. The final tolerance reassessment
decision for this chemical will be issued once the cumulative risks for all of the organophosphates are
considered. The Agency may need to pursue further risk management measures for dicrotophos once
cumulative risks are considered.
The revised risk assessments are based on review of the required target data base supporting
the use patterns of currently registered products and new information received. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the
Agency issued its risk mitigation decision on dicrotophos. After considering the revised risks, as well as
mitigation proposed by Amvac Chemical Company, the technical registrant of dicrotophos, and
comments and mitigation suggestions from other interested parties such as USDA and the US Cotton
Council, EPA developed its risk management decision for uses of dicrotophos that pose risks of
concern. This decision is discussed fully in this document.
Dicrotophos is an organophosphate acaricide/insecticide used on a variety of insects, first
registered in 1964 for use on cotton and various seed crops. Use data from 1987 to 1998 indicate an
average domestic use of approximately 502,000 Ibs a.i. per year.
Overall Risk Summary
EPA's human health risk assessment for dicrotophos indicates some risk concerns. Food risk,
both acute and chronic, is well below the Agency's level of concern. Similarly, drinking water risk
estimates based on screening models, from both ground and surface water for acute and chronic
exposures, are not of concern. There are, however, concerns for workers who mix, load, and apply
dicrotophos to agricultural sites. Also, EPA has identified acute and chronic risks to birds and
mammals that are of concern, and some risk to aquatic species.
To mitigate risks of concern posed by the uses of dicrotophos, EPA considered the mitigation
proposal submitted by the technical registrant, as well as comments and mitigation ideas from other
interested parties, and has decided on a number of label amendments to address the worker and
ecological concerns. Results of the risk assessments, and the necessary label amendments to mitigate
those risks, are presented in this interim RED.
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Dietary Risk
Acute and chronic dietary risk assessments for food and drinking water do not exceed the
Agency's level of concern; therefore, no mitigation is warranted at this time for any dietary exposure to
dicrotophos.
Occupational Risk
Occupational exposure to dicrotophos is of concern to the Agency, and it has been determined
that a number of mitigation measures are necessary. For the agricultural uses of dicrotophos, several
mixer/loader/applicator risk scenarios currently exceed the Agency's level of concern (i.e., MOEs are
less than the target MOE of 300). EPA believes these risks can be reduced with the following label
restrictions: (1) reducing maximum seasonal application to 0.83 Ib ai/A from the current 1.5 Ib ai/A, (2)
prohibiting aerial applications with a ptiase-out so that no dicrotophos can be applied by air after
January 1,2005, (3) requiring closed mixing loading systems and closed cabs for handlers, and (4)
increasing REI to 6 days for postapplication workers.
Therefore, with the addition of the label restrictions and amendments detailed in this document,
the Agency has determined that, until the outcome of cumulatives risks for all of the organophosphates
has been considered, all currently registered uses of dicrotophos may continue.
Ecological Risk
Ecological risks are also of concern to the Agency.
The mitigation measures of reducing maximum seasonal application rate to 0.83 Ib ai/A, and
prohibiting aerial applications are expected to lessen, but not eliminate the risk of dicrotophos to
wildlife. Further, restricting use to 0.5 Ib ai/A prior to August 1 is expected to lessen exposure to birds
during the breeding season.
For the uses of dicrotophos the Agency has determined that, with the adoption of all of the label
amendments noted in this document, these uses may continue until the outcome of the cumulative risks
of all of the organophosphates has been considered.
The Agency is issuing this interim Reregistration Eligibility Document (RED) for dicrotophos, as
announced in a Notice of Availability published in the Federal Register. This interim RED document
includes guidance and time frames for complying with any necessary label changes for products
containing dicrotophos. Note that there is no comment period for this document, and that the time
frames for compliance with the label changes outlined in this document are shorter than those given in
previous REDs. As part of the process discussed by the TRAC, which sought to open up the process
to interested parties, the Agency's risk assessments for dicrotophos have already been subject to
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numerous public comment periods, and a further comment period for dicrotophos was deemed
unnecessary. Phase 6 of the pilot process did not include a public comment period; however, for some
chemicals, the Agency may provide for another comment period, depending on the content of the risk
management decision. With regard to complying with the risk mitigation measures outlined in this
document, the Agency has shortened this time period so that the risks identified herein are mitigated as
quickly as possible. Neither the tolerance reassessment nor the reregistration eligibility decision for
dicrotophos can be considered final, however, until the cumulative risks for all organophosphate
pesticides is considered. The cumulative assessment may result in further risk mitigation measures for
dicrotophos.
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
decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. The Act 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. Dicrotophos belongs to a group of pesticides called
organophosphates, which share a common mechanism of toxicity - they all affect the nervous system by
inhibiting cholinesterase. Although FQPA significantly affects the Agency's reregistration process, it
does not amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its
reregistration program while it resolves the remaining issues associated with the implementation of
FQPA.
This document presents the Agency's revised human health and ecological risk assessments; its
progress toward tolerance reassessment; and the interim decision on the reregistration eligibility of
dicrotophos. It is intended to be only the first phase in the reregistration process for dicrotophos. The
Agency will eventually proceed with its assessment of the cumulative risk of the OP pesticides and issue
a final reregistration eligibility decision for dicrotophos.
-------
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
• 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
Sept. 29, 2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from organophosphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may be
exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will be
handled similarly. Generally, basic protective measures such as closed mixing and loading systems,
enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be necessary
for most uses where current risk assessments indicate a risk and such protective measures are feasible.
The policy also states that the Agency will assess each pesticide individually, and based upon the risk
assessment, determine the need for specific measures tailored to the potential risks of the chemical.
The measures included in this interim JtlED 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
-------
mitigation PR notice. Section II provides a profile of the use and usage of the chemical. Section III
gives an overview of the revised human health and environmental effects risk assessments resulting from
public comments and other information. Section IV presents the Agency's interim decision on
registration eligibility and risk management decisions. Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Section VI provides
information on how to access related documents. Finally, the Appendices list Data Call-in (DCI)
information. The revised risk assessments and related addenda are not included in this document, but
are available on the Agency's web page www.epa.gov/pesticides/op, and in the Public Docket.
II. Chemical Overview
A. Regulatory History
Dicrotophos was first registered in the United States in 1964 by Shell Oil Company as a
contact systemic insecticide for use on cotton and various seed crops. In October 1972, a registration
was issued for use of an 82% product as a tree injection treatment for systemic suppression of certain
insects in ornamental and non-crop trees. In June 1982, dicrotophos was registered for use on
ornamentals as a foliar application, but was voluntarily cancelled for this use by the registrant in
November 1982. The registration for tree injection treatment is a repackaging of formulated product.
This registration is held by J.J. Mauget, Company. In October 1986, the Shell Oil company transferred
dicrotophos registrations to DuPont Corporation, and in January 1994, registrations were transferred to
Amvac Chemical Company. A Registration Standard was issued for dicrotophos in 1982. A Data-
Call-In (DCI) was issued for reregistration in 1991.
B. Chemical Identification
O C H , O
H 3C O / O
O C H,
Solubility 1.0xl06ppm
Vapor Pressure 2.2 x 10"5 mm Hg
Henry's Constant 3.1 x 1 (T1' Atm M3/Mol (Calculated)
KOC ll-187ml/g
-------
Common Name: Dicrotophos (3-hydroxy-N,N-dimethyl-cis-crotonamide,
dimethyl phosphate)
Chemical family: Organophosphate
• Case number: 0145
CAS registry number: 141-66-2
• OPP chemical code: 035201
Empirical formula: C8H,6NPO5
Molecular weight: 237.19g/mol
Trade and other names: Bidrin
• Basic manufacturer: AMVAC
Dicrotophos is a mixture of the E- and Z-isomers in which the E-isomer is pesticidally active.
Technical dicrotophos is a yellow to dark amber liquid at room temperature with a boiling point of 111-
112° C at 0.022 mm Hg (399° C at 760 mm Hg). Dicrotophos is miscible (mixable in all proportions)
with water, acetone, alcohol, acetonitrile, chloroform, methylene chloride, and xylene. Dicrotophos is
only slightly soluble in kerosene and diesel fuel.
C. Use Profile
Dicrotophos is a contact, systemic acaricide/insecticide registered for use on cotton [40 CFR
§180.299]. The only dicrotophos end-use formulation currently registered is a water-miscible
formulation (Bidrin®) which may be applied foliarly to established cotton plants or used as a tree
injection treatment for ornamental and non-food producing trees. At this time products containing
dicrotophos are registered for occupational use only. It is classified as Restricted Use and may be
purchased and used only by certified applicators or persons under their direct supervision.
Type of Pesticide: Insecticide
Summary of Use Sites: Cotton, ornamental and non-food bearing trees
Residential: There are no homeowner uses of dicrotophos. The
tree injection product may be used on residential trees,
-------
Target Pests:
Formulation Types
Registered
Equipment:
Use Rates:
Use Classification:
but it is applied by certified applicators and is not
expected to result in residential exposures.
Formulated for use on cotton. Dicrotophos is used to
control: aphids, thrips, spider mites, cotton fleahoppers,
stinkbugs, grasshoppers, boll weevils, black
fleahoppers, plantbugs (lygus), saltmarsh caterpillars,
and leaf perforators.
The only dicrotophos end-use formulation currently
registered is an 82% water-miscible formulation
(Bidrin®) which may be applied foliarly to established
cotton plants or used as a tree injection for ornamental
and non-food bearing trees.
Spray applied aerially and by groundboom equipment
for cotton. Closed 3-mL ampules with delivery tube
for tree-injection
Maximum 3 applications per growing season at a
maximum label application rate 0.5 Ib ai/A.
Restricted use
D. Estimated Usage of Pesticide
Approximately 502,000 Ibs a.i. of dicrotophos are used annually, according to Agency
and registrant estimates. The estimated average acres treated are 1,513,000 acres or 10% of cotton.
Dicrotophos is primarily used in the Mississippi Valley region.
Table 1. Quantitative Usage Assessment for Dicrotophos
Site
Cotton
Acres
Grown
(000)
15,135
Acres Treated
(000)
Wtd
Avg
1,513
Est
Max
1,98
6
% of Crop
Treated
Wtd
Avg
10%
Est
Max
13%
LB AI
AppUed
(000)
Wt
d
Avg
502
Est
Ma
X
659
Average Application
Rate
Ibai/
acre/y
r
0.33
#app
i/yr
1.4
Ibai/
A/ap
Pi
0.23
States of Most
Usage
(% of total Ib ai
used
on this site)
TX, MS, AR,
LA, TO 85%
NOTES
Sources USDA National Agricultural Statistics Service, and US EPA Proprietary Data.
Usage data primarily cover 1994 - 2000 Values are rounded to the nearest 1000 for acres or pounds and the nearest whole % for crop
treated
-------
III. Summary of Dicrotophos Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide dicrotophos, as fully presented in the documents, "HED
Risk Assessment for Reregistration Eligibility Document Chemical # 035201," dated 10/28/99 and
revised on 11/7/01, and "EFED RED Chapter for Dicrotophos," dated 10/28/98 and "Revised Surface
Water EECs (Incorporating the Index Reservoir and Percent Crop Area)" dated 10/24/01. The
purpose of this summary is to assist the reader by identifying the key features and findings of these risk
assessments, and to better understand the conclusions reached in the assessments.
These risk assessments for dicrotophos were made available to the public allowing for an
opportunity for public comment on risk management for this pesticide. The risk assessments presented
here form the basis of the Agency's risk management decision for dicrotophos only; the Agency must
consider cumulative 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 dicrotophos on January 10, 2000 (Phase 3 of
the TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessments were updated and refined. Major revisions to the human health risk assessment are listed
below: Additional studies were submitted by the registrant, were reviewed by EPA and were
incorporated into the risk assessment. These data reduced some uncertainty factors and resulted in
new endpoints. The submitted studies are (1) a prenatal developmental toxicity study in rabbits, (2)
14-day and 28-day dermal toxicity studies in rats with ChE determination, and (3) a delayed
neurotoxicity study in hens.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is mostly complete, and that it supports an interim reregistration eligibility determination for all
currently registered uses. Further details on the toxicity of dicrotophos can be found in the 11/7/01
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
Based on newly submitted studies and reevaluation of existing studies, the FQPA Safety Factor
Committee recommended that the FQPA safety factor for dicrotophos be reduced to 3x for all
population subgroups when assessing chronic dietary exposure and Ix for acute dietary exposure
(HED DOC NO 014699, date 10/24/01, B. Tarplee). This supercedes the previous recommendation
-------
from the FQPA Recommendations for the Organophosphates that lOx be retained for acute and
chronic endpoints. The FQPA committee recommended that the safety factor be reduced to 3x for all
population subgroups when assessing chronic dietary exposure because there is qualitative evidence of
increased susceptibility in the multigeneration reproduction study based on effects on rat pups being
more severe than effects on adults. However, there is no quantitative or qualitative evidence of
increased susceptibility following in utero exposure to dicrotophos in the prenatal developmental studies
in rats or rabbits. The 3x safety factor is required only for chronic dietary exposure since concern for
susceptibility seen in the multigeneration reproduction study is not considered to result from an acute
exposure. The dietary food exposure assessment does not underestimate potential exposures to infants
and children from dicrotophos residues in food. No exposure is expected to infants and children from
residential (non-occupational) sources because dicrotophos is registered for use on cotton and for tree-
injection and neither use should result in residential exposures.
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary
Risk Assessment of Dicrotophos
Assessment
Acute Dietary
Chronic
Dietary
Dose
LOAEL=
0.5 mg/kg/day
LOAEL=
0.02 mg/kg/day
Endpoint
decreased plasma,
RBC and brain ChE
activity on day 1 was
observed (a NOAEL
was not established).
decreased plasma,
RBC and brain ChE
activity in both sexes
was observed (a
NOAEL was not
established).
Study
Acute
Neurotoxicit
y -Rat
MRID
43759801
Chronic
Toxicity -
Rat
MRID
44328402
UF
300
300
FQPA
Safety
Factor
lx
3x
PAD
0.0017
mg/kg/day
0.00002
mg/kg/day
c. Population Adjusted Dose (PAD)
Acute 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 dicrotophos, the FQPA safety factor for acute dietary
exposure is 1; therefore, the acute RED equals the acute PAD. A risk estimate that is less than 100% of
the acute or chronic PAD does not exceed the Agency's risk concern.
-------
A rat acute neurotoxicity study resulted in a LOAEL of 0.5 mg/kg/day based on the decrease in
plasma, RBC and brain ChE activity observed on Day 1 (a NOAEL was not established). This dose is
appropriate since the effects were observed on Day 1 following a single dose. Also, an additional
Uncertainty Factor (UF) of 3 was applied for the use of a LOAEL for risk assessment. Uncertainty
Factor (UF): 300 (10 x for inter-species extrapolation, 10 x for intra-species variability and 3 x for lack
of a NOAEL).
Acute RiD = 0.5 mg/kg - 300 = 0.0017 mg/kg.
Acute PAD = Acute RfD - FQPA Safety Factor( 1) = 0.0017 mg/kg
Chronic PAD:
A rat combined chronic toxicity/carcinogenicity study resulted in an LOAEL of 0.02 mg/kg/day
was recommended for the endpoint because at this level decreased plasma, RBC and brain ChE
activity in both sexes was observed (a NOAEL was not established). An additional Uncertainty Factor
of 3 was applied for the use of a LOAEL for risk assessment. Uncertainty Factor (UF): 300 (10 x for
inter-species extrapolation, 10 x for intra-species variability and 3 x for lack of a NOAEL).
Chronic RfD = 0.02 mg/kg/day - 300 = 0.00007 mg/kg/day
Chronic PAD = 0.00007 mg/kg/day - FQPA Safety Factor (3) = 0.00002 mg/kg/day
d. Exposure Assumptions
The revised acute and chronic dietary (food) exposure analyses were conducted using the
Dietary Exposure Evaluation Model (E>EEM™) and revised toxiciry endpoints for dicrotophos. DEEM
incorporates consumption data generated in USDA's Continuing Surveys of Food Intakes by
Individuals (CSFII), 1989-91.
In the acute dietary assessment, exposure was compared to the acute Population Adjusted
Dose (aPAD) based on the acute reference dose (RfD) and a Ix FQPA Safety Factor. In the chronic
dietary assessment, exposure was compared to the chronic PAD based on the chronic RfD and
retention of a 3x FQPA Safety Factor. The Agency considers dietary residue contributions greater
than 100% of the PAD to be of concern. The acute and chronic analyses (Tier 3 for each analysis) are
refined estimates using anticipated residues from field trial data, and percent of crop treated data from
Biological Economic Analysis Division (BEAD). No monitoring data from USDA's Pesticide Data
Program (POP) or FDA's Surveillance Monitoring program were available for dicrotophos.
e. Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population
10
-------
Adjusted Dose does not exceed the Agency's risk concerns. Acute dietary exposures (mg/kg/day)
estimates at the 99.9th percentile were below the Agency's level of concern for all subpopulations. The
subgroup with the highest estimated exposure was children 1-6 yrs. Their exposure was estimated at
0.000004 mg/kg/day resulting in a risk estimate of 0.27% of the acute population adjusted dose
(aPAD). The general U.S. Population's acute dietary exposure and risk estimates were 0.000002
mg/kg/day and 0.12%oftheaPAD, respectively.
Chronic dietary exposures (mg/kg/day) estimates are below the Agency's level of concern for
all subpopulations. The subgroup with the highest estimated exposure was children 1-6 yrs their
estimated exposure was < 0.000001 mg/kg/day resulting in a risk estimate of 0.9% of the chronic
population adjusted dose (cPAD.) The general U.S. Population's chronic dietary exposure and risk
estimates were O.000001 mg/kg/day and 0.1% of the cPAD, respectively.
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. Based on the
above-calculated acute exposure from food, an acute Drinking Water Level of Comparison
(DWLOCacute) was calculated for acute dietary exposures to dicrotophos. The DWLOC is the
concentration in drinking water which, when combined or aggregated with exposures through food,
would result in an aggregate exposure which is acceptable. In other words, it is the theoretical
concentration of a pesticide in drinking water which would be an acceptable upper limit in light of the
total aggregate exposure to that pesticide through all pathways. If model-based estimated
concentrations in ground and surface waters are less than the DWLOCacute, EPA can conclude with
reasonable certainty that aggregate exposure through food and drinking water do not exceed EPA's
level of concern.
The calculated DWLOCacute is 17 ppb (based on the most highly exposed subgroup, children
1-6). The Agency's model-based estimates for maximum concentrations in surface and ground water
are 2.56 ppb and 0.005 ppb, respectively. Surface water concentrations were estimated with the
PRZM-EXAMS/IR model and the ground water concentrations were estimated with the SCI-GROW
model. Since the model-based estimate for concentrations in surface water and groundwater are below
the DWLOCacute (17 ppb), the Agency concludes with reasonable certainty that aggregate exposure to
dicrotophos through food and surface water, and food and ground water, will not result in unacceptable
exposure and risk.
A DWLOC was also calculated for chronic dietary exposures to dicrotophos. The Agency's
revised calculated DWLOCchromc is 0.2 ppb (based on the most exposed subgroup, children 1-6).
Model-based estimates for average concentrations of dicrotophos in surface and ground water are 0.2
ppb and 0.005 ppb, respectively. Since the model-based estimate for concentrations in surface water
(0.2 ppb ) equals the DWLOCchromc of 0.2 ppb and the ground water estimate of 0.005 ppb is well
11
-------
below the DWLOC, the Agency concludes with reasonable certainty that residues of dicrotophos in
food and drinking water do not result in levels of aggregate exposure which exceed the Agency's level
of concern. It is important to note that calculated surface water values for dicrotophos are within the
range of concentrations recently detected in surface water in the Mississippi River alluvial plane.
3. Occupational and Residential Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational handlers of dicrotophos include: individual
farmers or growers who mix, load, and/or apply pesticides, and professional or custom agricultural
applicators and professional applicator; of the tree injection product. 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. However, for
dicrotophos, the lack of a NOAEL in the toxicity studies selected for the occupational risk assessment,
results in an additional 3x safely factor; therefore, MOEs greater than 300 do not exceed the Agency's
risk concern.
a. Toxicity
The toxicity of dicrotophos is integral to assessing the occupational risk. All risk calculations
are based on the most current toxicity information available for dicrotophos. The toxicological
endpoints and other factors used in the; occupational risk assessments for dicrotophos are listed below.
12
-------
Table 3. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessments for Dicrotophos
Assessment
Short-term dermal
Intermediate- term
dermal
Long-term dermal
Short-term
inhalation
Intermediate -term
inhalation
Long term
inhalation
Dose
LOAEL=
2.0 mg/kg/day
MOE=300'
LOAEL=
0.5 mg/kg/day
MOE=300
LOAEL=
0.04 mg/kg/day
MOE=300
LOAEL=
0.02 mg/kg/day
MOE=300
Endpoint
Decreased RBC
ChE activity in male
rats and decreased
plasma ChE activity
in female rats (a
NOAEL was not
established).
The values were
recommended for
the endpoint
because at this
level decreased
plasma, RBC and/or
brain ChE activity
was observed (a
NOAEL was not
established).
Study
28 Day Dermal Toxicity- Rat"
MRID 45378201
28 Day Dermal Toxicity- Rat"
MRID 45378201
28 Day Dermal Toxicity- Rat"
MRID 45378201
Acute Neurotoxicity - Rat;
MRID 43759801
Subchromc Neurotoxicity-
Rat;
MRID 43980201
Chronic Toxicity-Rat
MRID 44328402
Absorption
factor
NA
NA
NA
100%
100%
100%
' An MOE of 300 applies to occupational exposure/nsk assessment due to lack of NOAEL.
' 21 day treatment with 1 week follow-up period without treatment
Dicrotophos belongs in acute toxicity category II for dermal and eye irritation and is a strong
skin sensitizer.
Table 4. Acute Toxicity Profile for Occupational Exposure for dicrotophos
Route of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
Toxicity Category
I
II
data gap
II
IV
strong sensitizer
MRID
00261098
43893901
00261098
-
00261098
00261098
00261098
Results
LD50 = 1 1 mg/kg male
LD50 = 8 mg/kg female
LD50 = 876 mg/kg male
LD50 = 476 mg/kg female
—
Lesions reversed by 14 days
No irritation
Strong sensitizer
13
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b. Exposure
It is EPA's policy to use data from the Pesticide Handlers Exposure Database (PHED) Version
1.1 to assess handler exposures for regulatory actions when chemical-specific monitoring data are not
available. PHED was designed by a task force of representatives from the U.S. EPA, Health Canada,
the California Department of Pesticide Regulation, and member companies of the American Crop
Protection Association. PHED is a software system consisting of two parts — a database of measured
exposure values for workers involved in the handling of pesticides under actual field conditions and a set
of computer algorithms used to subset and statistically summarize the selected data. Currently, the
database contains values for over 1,700 monitored individuals (i.e., replicates).
A dicrotophos handler exposure study was submitted to PHED (i.e., Bidrin Field Exposure
Study in Post-Emergent Application on Cotton, April 7, 1986, Shell Oil Co.). A detailed description
and specific results of the study are presented in the Revised Agricultural and Occupational Exposure
Assessment Document (D241596, T. Leighton, 10/26/01). The dicrotophos-specific handler data were
combined with other data from the PHED Version 1.1 were used to assess handler exposures for
dicrotophos.
Anticipated use patterns and application method and range of application rates were derived
from current labeling. Application rates specified on dicrotophos labels range from 0.1 to 0.5 pounds of
active ingredient per acre in agricultural settings, so scenarios were evaluated at 0.1, 0.2 and 0.5 Ibs
ai/A. The Agency typically uses acres treated per day values that are thought to represent eight solid
hours of work for specific types of application equipment. In this case, the assessment is based on 200
A/day for ground equipment and 1200 A/day for aerial 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 minimum to maximum levels of protection). The lowest suite of personal protective equipment
(PPE) is baseline PPE. If required (i.e., MOEs are less than the target, 300), increasing levels of risk
mitigation (PPE) are applied. If MOEs are still less than the target, engineering controls (EC) are
applied. In some cases, EPA will conduct an assessment using PPE or ECs taken from a current label.
The levels of protection that formed the: basis for calculations of exposure from dicrotophos activities
include:
• Baseline: Long-sleeved shirt and long pants, shoes and socks.
Minimum PPE: Coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical footwear plus socks, and chemical resistant headgear
for overhead exposures.
• Maximum PPE: Coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical footwear plus socks, chemical resistant headgear for
overhead exposures, and a respirator if risk is driven by inhalation.
14
-------
• Engineering controls: Engineering controls such as a closed cab tractor for application
scenarios, and a closed mixing/loading system such as a closed
mechanical transfer system for liquids.
Current dicrotophos labels for use on cotton require: Coveralls over short-sleeved shirt and
short pants, chemical resistant gloves, chemical footwear plus socks, protective eyewear, chemical
resistant headgear for overhead exposures, and a respirator. Chemical resistant aprons are also
required when workers are cleaning equipment, mixing or loading.
For dicrotophos, both short term and intermediate term assessments were conducted for handler
risks. The short term assessment is based on exposures ranging from 1 to 30 days and the intermediate
term assessment is based on exposures ranging from 1 to 6 months. Although information is not
available to determine what percentage of applicators apply dicrotophos to cotton continuously for more
than 30 days, it is believed to be a very small segment of commercial applicators.
Chemical specific dislodgeable foliar residue (DFR) data were submitted in support of the
postapplication assessment, but worker reentry exposure data were not available. Assessments were
conducted for short and intermediate term dermal exposures for hand tasks during harvesting as well as
early and late season irrigating, scouting and hand weeding activities.
c. Occupational Handler Risk Summary
At this time products containing dicrotophos are intended for occupational use only. It is
classified as Restricted Use and may be purchased and used only by certified applicators or persons
under their direct supervision. Dicrotophos is applied to cotton during early, middle, and late season
using aerial or groundboom equipment.
Dicrotophos may also be used as a tree injection product to control insects in ornamental and
non-food bearing trees. This application is completed in a closed system by professional pest control
personnel and is not expected to result in unacceptable levels of exposure if the current label restrictions
are followed. Therefore, the risk from this use was not assessed.
i) Agricultural Handler Risk
EPA has determined that there are potential exposures to mixers, loaders, applicators, or other
handlers during usual use-patterns associated with dicrotophos. Based on the use patterns, 4 major
exposure scenarios (each assessed at 3 different application rates) were identified for dicrotophos:
• (la) mixing/loading liquid formulation to support aerial applications,
• (1 b) mixing/loading liquid formulation to support groundboom applications,
• (2) applying spray with aircraft, and
• (3) applying spray with groundboom equipment.
15
-------
The results of the short and intermediate: term handler assessments are summarized in Table 5 below.
Shaded boxes indicate where MOEs are below the target level of 300.
Table 5. Agricultural Uses: Remaining Risk Concerns (combined dermal & inhalation MOEs)
Exposure Scenario"
Application
Rate1
(Ib ai/acre)
Area
Treate
db
A/
day)
Total MOEs for Short- Term Risks
Baseline*
min PPE
(Gloves
+
Double
Layer)
max PPE
(Gloves +
Double Layer +
respirator) +
Engineering
controls
Mixer/Loader
Fixing/Loading Liquid Formulations for
•\enal Application (la)
Fixing/Loading Liquid Formulations for
jroundboom Application (Ib)
0.5
0.2
0.1
0 5
0.2
0 1
1200
1200
1200
200
200
200
0.08
0.2
0.4
0.48
1.2
2.4
11
27
54
64
160
320
13
32
65
78
190
390
Applicator
Applying Sprays with an Airplane (2)
\pplymg with a Groundboom (3)
Exposure Scenario
05
02
0.1
05
02
0.1
Application
Rate'
(Ib ai/acre)
1200
1200
1200
200
200
200
Area
Treate
db
;A/day
)
No Data; see Engineering Controls
83
210
410
100
250
NA
(500)
120
300
NA (600)
26
65
130
160
390
780
44
110
220
270
680
1,400
Intermediate - Term Exposures
Baseline
min PPE
(Gloves
+
Double
Layer)
max PPE
(Gloves +
Double Layer +
respirator) +
Engineering
controls
Mixer/Loader
Fixing/Loading Liquid Formulations for
\enal Application (la)
Fixing/Loading Liquid Formulations for
jroundboom Application ( 1 b)
0.5
02
0.1
0.5
0.2
0.1
1200
1200
1200
200
200
200
0.079
0.2
0.39
0.47
1.2
2.4
Applicator
\pplymg Sprays with an Airplane (2)
\pplying with a Groundboom (3)
05
0.2
0 1
0.5
0.2
0 1
1200
1200
1200
200
200
200
3
7.6
15
18
45
91
8
20
40
48
120
240
No Data; see Engineering Controls
27
69
140
29
73
150
76
190
380
18
46
92
110
270
550
28
69
140
200
490
980
Footnotes:
Note Baseline mitigation = lony sleeve shirt, long pants, <.hoes, and socks.
16
-------
a Application rate taken from dicrotophos label (EPA 5481-448)
b Amount handled per day values from HED's Science Advisory Council for Exposure, Policy 009.1, "Standard Values for Daily
Acres Treated in Agriculture." Health Effects Division, Office of Pesticide Programs, September 2001.
c Total MOE = 1 / dermal MOE + 1 / inhalation MOE
d. Tree injection handlers and applicators were not assessed.
ii)
Post-Application Occupational Risk
The post-application occupational risk assessment considered exposures to workers entering treated
sites in agriculture. The following potential postapplication exposures scenarios were assessed:
• workers entering treated cotton fields to perform irrigating and hand weeding tasks during the early
and late season,
• workers entering treated cotton fields to perform hand harvesting tasks,
• workers entering treated cotton fields to perform mechanical harvesting tasks, and
• handlers entering treated cotton fields to perform scouting and crop-advising tasks during the early
season and late season.
Postapplication risks are mitigated for workers using a restricted-entry interval (REI). In general, the
REI is established based on the number of days following application that must elapse before the
pesticide residues dissipate to a level where estimated worker MOE's equal or exceed 300 while
wearing baseline attire (i.e., long-sleeve shirt, long pants, shoes, and socks). Under the Worker
Protection Standard for Agricultural Pesticides (WPS) - 40 CFR Part 170, entry to perform routine
hand labor tasks is prohibited during an REI and personal protective equipment cannot be considered as
a risk reduction measure in establishing the REI.
Postapplication risks are mitigated for crop advisors/scouts using entry restrictions, not restricted-
entry intervals. Postapplication risk assessment for crop advisors/scouts for dicrotophos is based on the
individual and averaged residue measurements from a dicrotophos dislodgeable foliar residue (DFR)
study conducted in two geographical areas (Texas, and Mississippi). Results of the post application
assessment for workers and scouts are summarized in Table 6 below.
Table 6. Postapplication Exposure/Risk Estimates
DAT-
0
1
2
3
4
5
6
7
8
9
Short- & Int.-Term MOE"
hand harvesters late season
application
40.4
53.4
70.7
93.6
124
164
217
287
380
NA
workers and scouts late season
67
89
118
156
207
273
362
NA
NA
NA
workers and scouts early season
5050
NA
NA
NA
NA
NA
NA
NA
NA
NA
17
-------
DAT1
Short- & Int.-Term MOE"
hand harvesters late season
application
workers and scouts late season
workers and scouts early season
a DAT = days after application
b Short- and Intermediate-term Dermal MOE = Short- and Intermediate-Term Dermal LOAEL (2 0 mg/kg) / dermal
dose (mg/kg/day).
Results of the postapplication assessment for short- and intermediate-term dermal exposures indicate
that for hand harvesting activities, postapplication MOE's are greater than 300 at day 8; for "late-
season" irrigating, scouting, and hand weeding activities, postapplication MOEs are greater than 300 at
day 6; and for "early-season" irrigating, scouting, and hand weeding activities, MOEs are greater than
300 on day 0. Although there are no data upon which to assess exposures and risks resulting from
mechanical harvesting activities, the Agency believes that significant worker exposure may be possible
from [mechanical harvesting cotton] activity. Dicrotophos cannot be applied within 30 days of harvest
and; therefore, exposures from hand or mechanical harvesting are not of concern for the postapplication
assessment.
Current labels give the REI as 48 hours.
iii)
Residential (Homeowner) Handler Risk
Dicrotophos has no homeowner uses. The tree injection product may be used on residential trees,
but it is applied by certified applicators ,ind is not expected to result in residential exposures.
B.
Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects
Division chapter, dated 10/28/98 available in the public docket and at www.epa.gov/pesticides/OP.
The only revision to this publicly available document is a revised drinking water assessment
discussed in the dietary risk section above.
1.
Environmental Fate and Transport
The environmental fate database for dicrotophos is essentially complete. The major
routes of dissipation for dicrotophos in the environment are microbial-mediated degradation in soil and
movement into surface and very shallow ground waters.
Laboratory studies showed that hydrolysis and photolysis are not major degradation pathways for
dicrotophos.
18
-------
Laboratory soil metabolism studies showed that dicrotophos degraded rapidly under aerobic and
anaerobic conditions. Under aerobic conditions, the soil half-life of dicrotophos was 2.7 days in a
Hanford sandy loam soil (pH 5.7). The major soil metabolite was N,N-dimethylacetoacetamide which
was present at 20% of applied after 5 days incubation and then declined to 1.0% after 14 days. Under
anaerobic conditions, dicrotophos degraded with a half-life of 7 days in a Hanford sandy loam soil. The
major degradates were N,N-dimethylacetoacetamide and the hydroxy derivative of N,N-
dimethylacetoacetamide, which accounted for 48% and 13% of the applied after 33 days postflooding.
Adsorption/desorption studies showed that dicrotophos was mobile in sand, sandy loam, silt loam
and clay soils with Freundlich K^ values ranging from 11-187. The major degradate, N,N-
dimethylacetoacetamide, was also highly mobile in both sand and sandy loam soils. Dicrotophos is not
expected to be volatile with a vapor pressure of 7.0 x 10"5 mm Hg at 20°C.
In supplemental terrestrial field studies in Mississippi and Georgia, dicrotophos dissipated with a
half-life of 2.2 days. The formation and decline of degradates were not addressed in these field studies.
2. Water resource assessment
Water modeling was conducted to determine potential exposure to aquatic animals. The modeling
results are summarized here. Refer to the EFED chapter for an in-depth discussion of the water models.
a. Ground water
The SCI-GROW II model was used to estimate a screening concentration of dicrotophos under
"worst case" conditions. SCI-GROW provides a screening concentration, an estimate of likely ground
water concentrations if the pesticide is used at the maximum allowed label rate in areas with ground
water exceptionally vulnerable to contamination. Results from this model indicate that the maximum
estimated concentration of dicrotophos in ground water is not expected to exceed 0.0048 ppb for the
majority of use sites.
b. Surface Water
The Agency used PRZM-EXAMS to calculate refined Estimated Environmental Concentrations
(EECs). The Pesticide Root Zone Model (PRZM, version 3.1) simulates pesticides in field runoff, while
the Exposure Analysis Modeling System (EXAMS, version 2.97-5) simulates pesticide fate and
transport in an aquatic environment (one hectare body of water, two meters deep). Estimates were
generated for dicrotophos from use on cotton grown on a Loring silt loam in the southern Mississippi
Valley. These estimates differ from the drinking water EEC's since the maximum possible application
rate and minimum interval were used instead of the typical rate and interval used in drinking water
assessment. Also, the ecological aquatic EECs were estimated with the farm pond and not the Index
Reservoir amendment. EEC's are tabulated below.
19
-------
Table 7: Estimated Environmental Concentrations (EECs) of Aquatic Exposure for Use of
Dicrotophos on Cotton
Analytical
Model
PRZM/EXAMS
Application
Method
Aerial spray
Application
Rate
(Ibs ai/A)
0.5
# of Application
(Interval
between
Applications)
3 (5 days)
Peak EEC
(ppb)
21.3
21 -day
Average
EEC (ppb)
8.51
60-day
Average
EEC (ppb)
3.46
These values reflect an aerial application of dicrotophos which may result in direct spray drift
deposition into surface waters adjoining target use sites. The drift potential for aerial and ground spray is
assumed to be equivalent to 5% of applied and 1% of applied, respectively.
The PRZM-EXAMS upper 10th percentile peak EEC was 21.26 ppb, while the yearly upper tenth
percentile was 0.614 ppb. Although dicrotophos could reach surface water, it does not appear to
persist.
3. Toxicity (Hazard) Assessment
a. Avian/Mammalian Toxicity
Dicrotophos is classified as very highly toxic to birds and to other terrestrial wildlife, particularly
mammals on an acute oral basis. Dicrotophos has been shown to be very highly toxic to several species
of birds on an acute basis with LD50 values ranging from 2.0 to 9.6 mg/kg. On a subacute basis with
dicrotophos mixed in the diet for five days, LD50 values ranged from 13 to 144 ppm. These subacute
values are considered to be highly to veiy highly toxic to several species.
Table 8. Acute Oral Toxicity to Birds
Species
Acute Oral (Singh
Canada Goose (Branta canadensis) (MRID 00160000)
California quail (male)
(Callipepla californica) (MRID 00160000)
House sparrow (male)
(Passer domesticus) (MRID 00160000)
Subacute dietary1 (five
Japanese quail
(Coturnix coturmx japonica) (MRID 00022923)
LD5. (mg/kg)
' dose by gavage)
2.28
1.89
3.00
days of treated feed)
32
Toxicity Category
Very highly toxic
Very higly toxic
Very highly toxic
Very highly toxic
' Test organisms observed an additional three days while on untreated feed.
Chronic effects to birds measured by avian reproduction studies show reproductive effects at low
levels.
20
-------
Table 9. Reproductive Toxicity to Birds
Species/
Study Duration
Northern bobwhite
(Colinus virgmianus)
(MRID 44005502)
Mallard duck
(Anas platyrhynchos)
(MRID 44005501)
NOEC (ppm
ai)
0.50
1.0
3.0
LOEC (ppm
ai)
1.5
3.0
10
LOEC Endpoints
Egg production and food consumption
Female body weight
Egg production, embryo viability,
hatching production and survival, egg
shell thickness, and male body weight
Wild mammal testing is not required for dicrotophos. Rat toxicity values obtained from the Agency's
Health Effects Division (HED) substitute for wild mammal testing. Acute and chronic rat toxicity data
relevant to ecological effects show that dicrotophos is very highly toxic to small mammals on an acute
oral basis. Dicrotophos appears to be slightly less toxic to mammals than to birds. Dicrotophos affects
mammalian reproduction at dietary concentrations of 5 ppm and greater (MRID 00013446). Chronic
mammalian effects are body weight gain and fasciculation development, female fertility and offspring
survival.
Dicrotophos is also highly toxic to honeybees (MRID 05001991); residues on foliage have been
found to remain toxic to bees and other beneficial insects for 2 to 16 days (MRIDs 05009353 and
05013577).
b. Toxicity to Aquatic Animals
Dicrotophos has been shown to be moderately to slightly toxic to fish with 96-hour LC50s ranging
from 6-84 ppm (MRID 40098001). Chronic data were not required based on the acute toxicity to
freshwater and estuarine fish. Dicrotophos is, however, very toxic to aquatic invertebrates and therefore
may indirectly affect fish by reducing the food supply offish and aquatic animals.
Toxicity of dicrotophos to freshwater and estuarine/marine aquatic invertebrates is presented in the
table below. The preferred test species for these tests were more sensitive to dicrotophos than other
tested organisms. The Agency notes also that the tests conducted with the scud and stonefly might
underestimate toxicity because they were not conducted with the most sensitive life-stage.
21
-------
Table 10. Acute Toxicity to Aquatic Invertebrates
Species,
Study Type
EC» (ppb ai)
48-hr 1 96-hr
Toxicity Category
Freshwater
Waterflea
(Daphnia magna), Flow-through
(MRID 43787901)
12.7
--
Very highly toxic
Estuarine/Marine
Mysid
(Americamysis bahia)
(MRID 44956501)
--
0.077
Very highly toxic
Chronic data for freshwater invertebrates show that growth was the most sensitive endpoint to
dicrotophos testing (MRID 44956501). The NOAEC for growth was 0.99 ppb with a LOAEC of 1.7
ppb. Reproduction NOAEC was 2.8 ppb. Chronic tests show that an estuarine/marine invertebrate is
less sensitive than the tested freshwater invertebrate. Based on measured concentrations, dicrotophos
inhibited the growth of mysids at concentrations of 6.15 ppb and greater. The NOAEC for growth was
3.09 ppb, reproduction of mysid was impaired at a concentration of 45.4 ppb.
c. Toxicity to Plants
Toxicity to terrestrial and aquatic plants are not required for dicrotophos because it is not a herbicide
and there is no information indicating that its use might result in phytotoxicity problems.
4. Exposure and Risk Calculations
a. Levels of Concern
Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the
likelihood of adverse ecological effects. The Agency calculates risk quotients (RQs) by dividing
exposure estimates by acute and chronic ecotoxicity values:
RQ= EXPOSURE/TOXICITY
RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used by OPP to
indicate potential risk to nontarget organisms and the need to consider regulatory action. The criteria
indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget
organisms. Risk presumptions, along with the corresponding LOCs, are given in the table below:
22
-------
Table 11. Risk Presumptions for Terrestrial and Aquatic Animals
Risk Presumption
Acute High Risk there is potential for acute risk; regulatory action may
be warranted in addition to restricted use classification,
Acute Restricted Use -there is potential for acute risk, but may be
mitigated through restricted use classification,
Acute Endangered Species -endangered species may be adversely
affected; regulatory action may be warranted,
Chronic Risk -there is potential for chronic risk; regulatory action may be
warranted.
LOG
terrestrial animals
0.5
0.2
0.1
1
LOC
aquatic animals
0.5
0.1
0.05
1
b. Exposure and Risk to Nontarget Terrestrial Animals
i) Avian Risk
Screening Level Acute Avian Risk
The acute risk quotients for broadcast applications of emulsifiable concentrate (EC) products are
given in Table 12.
Table 12. Avian Acute Risk Quotients for Single Application of Dicrotophos as an EC Product,
Based on a Japanese Quail LCsn of 32 ppm.
Site
(application method)
Use Rate
(Ibs ai/A)
No. of
Applications
Food Items
Maximum EEC
(ppm)
Acute RQ
(EEC/LC50)
Cotton
Cotton
0.5
0.5
1
3
Short grass
Tall grass
Broadleaf
plants/Insects
Seeds
Short grass
Tall grass
Broadleaf
plants/Insects
Seeds
120
55
68
7.5
160
74
92
11
3.80
1.70
2.10
0.23
5.00
2.30
2.90
0.34
The risk quotients for both single and multiple broadcast applications of dicrotophos exceed the
avian acute high risk LOC for all wildlife food types except seeds. Therefore, terrestrial residues of
dicrotophos are expected to pose a high risk of causing mortality to birds. Acute risk is not predicted
23
-------
for birds that are strictly seed eaters, but they also could be at risk if they receive significant exposure
through other routes. The risk quotients for all food categories exceed the LOCs for consideration of
restricted use registration (0.2) and risk to threatened and endangered species (0.1).
Refined avian assessment
Based on the above screen which indicated acute risk to birds and field studies where acute avian
effects were seen, a refined risk assessment was conducted for three model species: the Canada goose,
the northern bobwhite quail, and the marsh wren.
These species represent large herbivorous waterfowl (Anatidae), medium-sized game birds
(Phasianidae), and small insectivorous songbirds (Passeriformes), respectively. The toxicity of the
bobwhite was assumed to be equivalent to the California quail (Callipepla californica), and toxicity of the
marsh wren was assumed to be equivalent to the house sparrow (Passer domesticus). Food
consumption rates for these species were approximated based on information provided in the EPA
Wildlife Exposure Handbook (EPA/600/R-93/187a). The diet for the bobwhite was assumed to be
composed of 25% insects, which is near the upper bound for adult bird. Risk for bobwhite chicks,
however, would be greater since their diet is nearly all insects. Estimates of maximum and average
residue levels of dicrotophos on wildlife food was based on the model of Hoerger and Kenega (1972),
as modified by Fletcher et al. (1994). Toxicity and exposure data were combined to estimate the
number of doses equivalent to the LD50 that the bird is predicted to consume in a single day
("LD50/day").
Table 13. Refined Assessment of Avian Acute Risk Quotients Based on LD50s of Three
Surrogate Birds
'JS. ' • & '"'•
<# Of -£*'>'
*Appl|-Jr;:'
cations 7
' '''"";'!suCi
1 app at
0.5 Ib ai
3 apps at
0.5 Ib ai
Model
Organism
Canada
goose
Quail
Small
passerine
Canada
goose
Quail
Small
passerine
LDW
mg/kg
2.28
1.89
3.00
2.28
1.89
3.00
Diet
Short grass
75% seeds &
pods
25% small insects
Small insects
Short grass
75% seeds &
pods
25% small insects
Small insects
%BW
Consumed
per Day
3.1
7.3
97.5
3.1
7.3
97.5
EEC (ppm)
Max.
120
23
68
160
31
92
Ave
43
8.3
23
58
11
30
Acute RQ
Max Ave
1.63
0.89
22.10
2.18
1.21
29.90
0.58
0.32
7.48
0.79
0.42
9.75
24
-------
Table 13. Refined Assessment of Avian Acute Risk Quotients Based on LDsos of Three
Surrogate Birds
•>--- '•:
-:.*$f,
. m.s t't- •
mt^ ;•
:;^gp)i- ,',
aljStit'ons' ••
Model
Organism
LDso
mg/kg
Diet
%BW
Consumed
per Day
EEC (ppm)
Max. 1 Ave
Acute RQ
Max Ave
exceeds acute high, acute restricted and acute endangered species LOCs.
* exceeds acute restricted and acute endaneered soecies LOCs.
Refined risk quotients for the Canada goose and a small passerine both exceed the LOG for high
(0.5) risk for single and multiple applications, even if average residues are assumed. The refined RQs
for quail also exceed the LOG for high risk when maximum residues are used, and is only slightly below
the acute risk LOG when average residues are used. All of the RQs exceed the LOCs for consideration
of restricted use (0.2) and risk to threatened and endangered species (0.1). These results confirm the
first tier assessment in concluding that use of dicrotophos on cotton poses an acute risk of killing many
different types of birds, and poses a risk to threatened and endangered birds, even with a single
application. These conclusions of acute risk drawn from the refined assessment have high certainty.
Chronic Risks to Birds
Avian chronic risk quotients are given in Table 14. Chronic risk was assessed using two
approaches. In the first approach, "maximum" risk quotients were calculated by dividing the bobwhite
NOEC by the maximum EECs for wildlife food items. This approach is a conservative screen in which
exposure is assumed to be at peak residue levels which occur immediately after the last application. For
multiple applications, residues were assumed to dissipate between applications at a half-life of 2.7 days.
In the second approach, "30-day mean" risk quotients were calculated by dividing the bobwhite NOEL
by the mean EECs for a 30-day period, beginning with the day of the first application. Residues were
assumed to dissipate during this 30-day period with a half-life of 2.7 days.
Any risks indicated by 30-day mean risk quotients are highly certain because a 30-day exposure
period is long enough to produce chronic effects in birds similar to those observed in the laboratory.
Most of the observed chronic effects result in reproduction effects.
Table 14. Avian Chronic Risk Quotients for Use of EC Products of Dicrotophos on Cotton,
Based on a Bobwhite NOEC of 0.5 ppm
UseRate
()bs ai/A)
05
Number of
Applicatio
n
1
Food Items
Short grass
EEC (ppm)
Maximum
120
30-Day
Mean'
18
Chronic RQ (EEC/NOEC)
Maximum 30-Day
Mean'
240 36
25
-------
Table 14. Avian Chronic Risk Quotients for Use of EC Products of Dicrotophos on Cotton,
Based on a Bobwhite NOEC of 0.5 ppm
UseRate
(Ibs ai/A)
0.5
Number of
Applicatio
n
3
Food Items
Tall grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insec ts
Tall Grass
EEC (ppm)
Maximum
55
68
7.5
160
74
92
11
30-Day
Mean'
8 1
10
1.1
53
24
30
3.3
Chronic RQ (EEC/NOEC)
Maximum 30-Day
Mean'
110
140
16
320
150
180
22
16
20
2.2
110
48
60
6.6
Both the maximum and the 30-day risk quotients indicate that use of dicrotophos on cotton at a rate
of 0.5 Ib ai/A will result in chronic risk to birds. The risk quotient values, even when 30-day mean EECs
were used, suggest that the occurrence of chronic effects is probable, despite the minimal persistence of
dicrotophos.
ii)
Risks to Mammals
Acute Risk to Mammals
Estimating the potential for adverse effects to wild mammals is based upon EEB's draft 1995 SOP of
mammalian risk assessments and methods used by Hoerger and Kenaga (1972) as modified by Fletcher
et al. (1994). The concentration of dicrotophos in the diet that is expected to be acutely lethal to 50%
of the test population (LC50) is determined by dividing the LD50 value (usually rat LD50) by the %
(decimal of) body weight consumed. A risk quotient is then determined by dividing the EEC by the
derived LC50 value. Risk quotients are calculated for three separate weight classes of mammals (15,
35, and 1000 g), each presumed to consume four different kinds of food (grass, forage, insects, and
seeds). The acute risk quotients for the most sensitive mammal, the 15 g animal, are given in Table 15.
Table 15. Mammalian (15 g animal) Acute Risk Quotients for Applications of Dicrotophos,
Based on a rat LDSO of 9 mg/kg
Site
(application
method)
Cotton
Use Rate
(Ibs ai/A)
0.5
#. of
Apps
1
Food Items
Short grass
Broadleaf
plants/small insects
% body
weight
consumed
95
95
Maximu
mEEC
(ppm)
120
68
Acute RQ
(EEC/LC50)
12.67
7.18
26
-------
Table 15. Mammalian (15 g animal) Acute Risk Quotients for Applications of Dicrotophos,
Based on a rat LDsn of 9 mg/kg
Site
(application
method)
Cotton
Use Rate
(Ibs ai/A)
0.5
#. of
Apps
3
Food Items
Large insects
Seeds
Short grass
Broadleaf
plants/small insects
Large insects
Seeds
% body
weight
consumed
95
21
95
95
95
21
Maximu
mEEC
(ppm)
7.5
7.5
160
92
11
11
Acute RQ
(EEC/LC50)
0.79
0.18
16.89
9.71
1.16
0.26
Risk quotients exceed the acute risk LOG (0.5) for most herbivorous and insectivorous mammals
(all except larger mammals that feed on larger insects). Risk quotients for granivorous mammals do not
exceed the high risk LOG, but do exceed the endangered species LOG (0.1) for small and medium
mammals.
For three applications, acute risk quotients exceed the high acute risk LOG (0.5) for most
herbivorous and insectivorous mammals (all except larger mammals that feed on larger insects). Risk
quotients for granivorous mammals do not exceed the high risk LOG, but do exceed restricted use LOG
(0.2) for small mammals, and the endangered species LOG (0.1) for small and medium mammals.
Ghronic Risk to Mammals
Chronic risk quotients for mammals are presented in Table 16. These risk quotients are based on
the NOAEL of 2.0 ppm that was established in a 3-generational rat reproduction study. While a short-
term exposure to the peak concentration possibly could cause chronic effects, exposure over a longer
duration would have a greater certainty of causing these effects. Therefore, chronic risk to mammals
was also assessed based on average EEC's for a 30-day period, beginning with the day of the first
application, as well as on peak EEC's.
Table 16. Mammalian Chronic Risk Quotients for Use of EC Products of Dicrotophos on
Cotton, Based on a Rat NOAEL of 2 ppm
Use rate
(Ibs ai/A)
0.5
#of
Applications
1
Food Items
Short grass
Tall grass
EEC (ppm)
Maximu
m
120
55
30-Day
Mean1
18
8.1
Chronic RQ
(EEC/NOAEL)
Maximu
m
60
28
30-Day
Mean'
9.0
4.1
27
-------
Table 16. Mammalian Chronic Risk Quotients for Use of EC Products of Dicrotophos on
Cotton, Based on a Rat NOAEL of 2 ppm
Use rate
(Ibs ai/A)
0.5
#of
Applications
3
Food Items,
Broadleaf
plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf
plants/Insects
Seeds
EEC (ppm)
Maximu
m
68
7.5
160
74
92
11
30-Day
Mean'
10
1.1
53
24
30
3.3
Chronic RQ
(EEC/NOAEL)
Maximu
m
34
3.8
80
37
46
5.5
30-Day
Mean1
5.0
0.55
27
12
15
1.7
Both the maximum and the 30-day risk quotients indicate that use of dicrotophos on cotton at a rate
of 0.5 Ib ai/A will result in chronic risk to mammals. The risk quotient values were high even when 30-
day mean EECs were used, suggesting that the occurrence of chronic effects in mammals is highly
certain.
iii)
Risk to Insects
Currently, the Agency does not conduct quantitative risk assessments for nontarget insects .
However, acute toxicity testing show that dicrotophos is highly toxic to honeybees (LD50=0.076 fig/bee,
MRID 05001991). Dicrotophos residues on foliage have been found to remain toxic to bees and other
beneficial insects for 2 to 16 days. Therefore, use of dicrotophos on cotton is expected to pose a high
risk to honeybees and other nontarget insects, especially when it is applied to flowering cotton plants.
c. Exposure and Risk to Nontarget Aquatic Animals
i) Risk to Fish
As a conservative screen, risk quotients were calculated based on three aerial applications at the
maximum use rate (0.5 Ib ai/A) with a 5-day interval between applications resulting in RQ's <0.01.
These RQ's are much lower than all levels of concern and therefore, the Agency concludes that this use
poses minimal risk to all fish, including endangered species. Chronic risk has not been assessed because
data on the chronic toxicity of dicrotophos to fish is not available.
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ii) Risk to Aquatic Invertebrates
Acute risk quotients are given in Table 17.
Table 17. Risk Quotients for Acute Effects on Aquatic Invertebrates from Use of
Dicrotophos on Cotton
Habitat Type
Freshwater
Marine and
estuarine
Test Species
Waterflea
Mysid
LC50
(ppb)
12.7
77
Peak EEC1
(ppb)
21.3
21.3
Acute RQ
(EEC/LC50)
1.68
0.28
'Based on three applications at the maximum application rate of 0.5 Ib ai/A.
For freshwater species, the risk quotient for use of dicrotophos on cotton at the maximum
application rate exceeds the levels of concern for acute high risk, restricted use, and endangered species.
Therefore, the Agency concludes that this use poses an acute risk to freshwater invertebrates. For
marine and estuarine invertebrates, the risk quotient is less than the level of concern for acute risk (0.5),
but exceeds the level of concern for restricted use and endangered species. Therefore, the Agency
concludes that this use does not pose acute risk to marine and estuarine species, but does pose enough
risk that effects on threatened and endangered species is a concern.
The chronic risk quotients are given in Table 18.
Table 18. Risk Quotients for Chronic Effects on Aquatic Invertebrates from Use of
Dicrotophos on Cotton
Habitat type
Freshwater
Marine and estuarine
Test Species
Daphnia magma
Mysid
MATC
Cppb)
1.3
4.36
2 1 -Day Average EEC'
(ppb)
8.51
8.51
Chronic RQ
(EEC/MATC)
6.55
1.95
'Based on three applications at the maximum application rate of 0.5 Ib ai/A.
For freshwater and marine and estuarine species, the risk quotients for use of dicrotophos on cotton
at the maximum application rate exceed the level of concern for chronic risk. Therefore, the Agency
concludes that this use poses a chronic risk to marine and freshwater invertebrates. No chronic data are
available for freshwater invertebrates. However, the Agency concludes that chronic risk to freshwater
species exists because acute toxicity indicates that freshwater invertebrates are more sensitive to
dicrotophos than are marine and estuarine invertebrates.
d. Exposure and Risk to Nontarget Plants
A risk assessment was not conducted for nontarget plants because dicrotophos is an insecticide and
there is no indication that it is phytotoxic. Risk to nontarget plants is assumed to be minimal.
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5. Ecological Incidents
From 1982 to present several ecological incidents involving dicrotophos poisoning were entered into
the OPP Incident Data System. Some of these incidents are linked to apparent mis-use or intentional
poisoning, in other incidents, dicrotophos was recovered from carcasses, but the source was unknown.
The absence of additional documented incidents involving non-targeted terrestrial organisms does
not necessarily mean that such incidents do not exist. Mortality incidents must be seen, reported,
investigated, and submitted to the Agency in order to be recorded in the database. Incidents may not be
noted because the carcasses decayed in the field, were removed by scavengers, or were in out-of-the-
way or hard-to-see locations. Poisoned birds may fly off-site to less conspicuous areas before dying.
An incident also may not be reported to appropriate authorities capable of investigating it.
6. Endangered Species
Endangered species LOCs are exceeded for acute and chronic risks to birds, mammals and
freshwater and estuarine invertebrates. At this time there are no federally listed estuarine invertebrates.
Dicrotophos was included in the fbnnal Section 7 consultation with the US Fish and Wildlife Service
(USFWS) for the cotton cluster review in 1983. The Biological Opinion stated that this use of
dicrotophos would jeopardize the continued existence of the Attwater's greater prairie chicken, the
Aleutian Canada goose, the Kern primrose sphinx moth, the valley elderberry longhorn beetle and the
delta green ground beetle.
Dicrotophos was also included in the reinitiated Biological Opinion of 1989 from the USFWS. In
this opinion, the USFWS found jeopardy to 14 species of freshwater fish, one freshwater crustacean
and four bird species for its uses on cotton. Reasonable and Prudent Alternatives were given for each
jeopardized species. Reasonable and Prudent Measures were also given for twelve non-jeopardized
species to minimize incidental take of these species. These consultations and the findings expressed in
the Opinions, however, are based on old labels and application methods, less refined risk assessment
procedures and an older approach to consultation which is currently being revised through interagency
collaboration.
When the regulatory changes recommended in this IRED are implemented and the ecological effects
and environmental fate data are submitted and accepted by the Agency, the Reasonable and Prudent
Alternatives and Reasonable and Prudent Measures in the Biological Opinion(s) may need to be
reassessed and modified based on the new information.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the National
Marine Fisheries Service under section 7(a)(l) of the Endangered Species Act. The objective of this
review is to clarify and develop consistent processes for endangered species risk assessments and
consultations. Subsequent to the completion of this process, the Agency will reassess the potential
effects of dicrotophos use to federally listed threatened and endangered species. At that time the
Agency will also consider any regulator/ changes recommended in the IRED that are being
implemented. Until such time as this analysis is completed, the overall environmental effects mitigation
strategy articulated in this document and any County Specific Pamphlets described in Section IV which
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address dicrotophos, will serve as interim protection measures to reduce the likelihood that endangered
and threatened species may be exposed to dicrotophos at levels of concern.
7. Risk Characterization
Like other OP pesticides, dicrotophos exhibits acute toxicity due to irreversible inhibition of
cholinesterase enzymes. Significant inhibition of brain and blood cholinesterases have been observed in
rats administered dicrotophos at doses as small as 0.5 mg ai/kg (MRID 43759801). As with humans,
exposure of wildlife to cholinesterase inhibiting pesticides disrupts normal neuromuscular control. Death
can occur rapidly, due primarily to respiratory failure. Organophosphate exposure can also result in
chronic effects in animals such as reproduction impairment and delayed neuropathy. Dicrotophos,
however, has relatively low toxicity to aquatic organisms compared to most insecticides. The primary
risk from the use of dicrotophos is acute and chronic effects in terrestrial vertebrates.
Monocrotophos is a highly toxic metabolite that can be formed by demethylation of dicrotophos and
is included in the tolerance expression for dicrotophos. Laboratory studies on the degradation of
dicrotophos do not indicate that monocrotophos forms in soil or water in any significant quantities.
Animal metabolism studies indicate that monocrotophos is not formed in significant amounts in the
metabolism of dicrotophos by animals. However, monocrotophos is a metabolite in plants since a
metabolism in cotton study found monocrotophos at harvest. These data are deemed to be unreliable
and the amount of monocrotophos that forms in or on foliage soon after application is currently not
known (Memorandum, April 2, 1997).
Terrestrial Organisms
An extensive amount of data are available which show that dicrotophos is very highly toxic to a wide
variety of birds and mammals. Reproductive impairment has been observed in both birds and mammals
at dietary concentrations between 1.5 and 5 ppm.
These avian and mammalian risk assessments are not believed to be conservative. There are
several reasons why the risk assessment may underestimate risk. Compared to animals in the
laboratory, animals in the wild might be more susceptible because they are exposed to multiple stressors
in addition to the chemical (e.g. extreme environmental conditions, predation pressure, and disease).
Furthermore, animals in the wild are likely to be exposed to pesticides through routes other than in the
diet (e.g., via drinking water, dermal absorption, and inhalation). And even though dicrotophos
degrades fairly rapidly, with a calculated half life of 2.7 days, residues may persist at toxic levels for
more than two weeks. Therefore, there appears to be a risk of mortality to all birds that feed in cotton
fields treated with dicrotophos, although the risk is most certain for songbirds.
Birds are known to make use of cotton fields for food and cover. Field studies conducted in cotton
fields in Alabama (MRID 40917001) and Arizona (MRID 40873701) both concluded that birds were
"diverse and had high species richness and abundance" in the test fields. Passarines (songbirds) were
the most common type of bird using cotton fields in both studies. Quail and doves were also fairly
common in cotton fields in Arizona. Bird use of cotton fields was higher in Arizona than in Alabama.
More birds are likely attracted to cotton fields in the Southwest because the irrigated fields provide
dense vegetative cover that is scarce elsewhere in the desert environment. In addition, cotton fields in
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the Southwest frequently occur along rivers, and the associated riparian habitats that are favored by
birds. Additional information on the use of cotton field by birds is provided by Gusey and Maturgo
(1973). Data for Georgia indicate that there is medium to high use of cotton by songbirds for feeding
during the summer months. In addition., data for Georgia, South Carolina, and Texas indicate medium to
high use of cotton by quail for feeding, nesting, and brood rearing.
Overall, songbirds and quail are likely to be the most frequently exposed birds in cotton treated with
dicrotophos. The risk assessment indicate that many songbirds are highly vulnerable to acute poisoning
by dicrotophos due to their small size and insectivorous feeding habit. The risk assessment indicate that
adult quail are somewhat less vulnerable but still at risk of acute poisoning. The vulnerability of young
quail, which are mostly insectivorous, is likely to be similar to that of songbirds. The field studies confirm
that use of dicrotophos on cotton can cause mortality of both quail and songbirds.
In addition to the acute risk, dicrotophos poses a risk of causing impairment of avian reproduction.
Risk quotients for chronic effects on birds, based on 30-day time-averaged residues, were 2.2 to 36 for
a single application, and 6.6 to 110 for three applications. Laboratory data show that the egg
production of the Northern bobwhite is reduced at dietary concentrations as low as 1.5 ppm. Peak
environmental concentrations on wildlife food items are predicted to be as high as 120 ppm. and
residues of dicrotophos are expected to remain at chronically adverse concentrations for several weeks.
With this level and duration of exposure, the probability of impairment of reproduction of birds feeding in
and around treated cotton fields is very high. Impaired reproduction and increased mortality of young
and old birds will work together to adversely affect population of birds around treated cotton fields.
Although studies have shown that dicrotophos is slightly less toxic to mammals than it is to birds,
dicrotophos is still very highly toxic to small mammals. Mammalian reproduction is affected at dietary
concentrations of 5 ppm and higher.
Acute toxicity testing show that dicrotophos is highly toxic to honey bees. Dicrotophos residues on
foliage have been found to remain toxic to bees and other beneficial insects for 2 to 16 days. Therefore,
use of dicrotophos on cotton is expected to pose a high risk to honeybees and other nontarget insects,
especially when it is applied to flowering cotton plants.
Aquatic organisms
Surface water models (PRZM-EXAMS) indicate that dicrotophos may reach surface waters at a
peak concentration of 37-21 ppb, but levels do not appear to accumulate. Ground water modeling
using the SCI-GROW II model show that dicrotophos is not expected to pose a significant ground
water problem (0.0048 ppb). NAWQA data indicate that in the cotton growing region of the
Mississippi Embayment, dicrotophos was the most frequently detected insecticide analyzed in 1996 and
1997. While the detections were at low concentrations, these monitoring data clearly support the
modeling estimates indicating that dicrotophos may be found in water sources.
Dicrotophos applied to cotton is likely to reach freshwater habitats and estuarine habitats along the
southern Atlantic Coast and the Gulf Coast. This exposure is not predicted to harm fish. Risk quotients
indicate a risk of acute effects to freshwater invertebrates, but not to marine or estuarine invertebrates.
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Risk quotients indicate risk of chronic effects to marine and estuarine invertebrates. Although the
Agency has no data on the chronic effects of dicrotophos to freshwater invertebrates, chronic risk is
assumed since acute risk is predicted. Although some of the risk quotients for aquatic invertebrates
indicate risk, the risk to aquatic environments does not appear to be particularly great relative to other
insecticides.
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim 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 is eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
active ingredient specific) data required to support reregistration of products containing dicrotophos
active ingredients.
The Agency has completed its assessment of the occupational and ecological risks associated with
the use of pesticides containing the active ingredient dicrotophos, as well as a dicrotophos-specific
dietary risk assessment that has not considered the cumulative effects of organophosphates as a class.
Based on a review of these data and public comments on the Agency's assessments for the active
ingredient dicrotophos, EPA has sufficient information on the human health and ecological effects of
dicrotophos to make interim decisions as part of the tolerance reassessment process under FFDCA and
reregistration under FIFRA, as amended by FQPA. The Agency has determined that dicrotophos is
eligible for reregistration provided that: (i) current data gaps and additional data needs are addressed;
(ii) the risk mitigation measures outlined in this document are adopted, and label amendments are made
to reflect these measures; and (iii) cumulative risks considered for the organophosphates support a final
reregistration eligibility decision. Additionally, if any party produces data to show, conclusively, that any
of these risk mitigation measures are unnecessary, the Agency will consider these data and will revise the
risk mitigation requirements accordingly. In particular, several stakeholders expressed interest in
developing exposure data to refine risk estimates for aerial mixer/loader/applicators. However, at this
time, the Agency has no data to further refine/revise the worker assessment for dicrotophos; therefore,
the mitigation measures are required. Label changes are described in Section IV. Appendix B identifies
the generic data requirements that the Agency reviewed as part of its interim determination of
reregistration eligibility of dicrotophos, and lists the submitted studies that the Agency found acceptable.
Although the Agency has not yet completed the cumulative risk assessment for the
organophosphates, the Agency is issuing this interim assessment now in order to identify risk reduction
measures that are necessary to support the continued use of dicrotophos. Based on its current
evaluation of dicrotophos alone, the Agency has determined that dicrotophos products, unless labeled
and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly,
should a registrant fail to implement any of the risk mitigation measures identified in this document, the
Agency may take regulatory action to address the risk concerns from use of dicrotophos.
At the time that a cumulative assessment is completed, the Agency will address any outstanding risk
concerns. For dicrotophos, if all changes outlined in this document are incorporated into the labels, then
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all current risks will be mitigated, though not eliminated. But, because this is an interim RED, the Agency
may take further actions, if warranted, to finalize the reregistration eligibility decision for dicrotophos
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.
Because 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 dicrotophos food residue tolerances as called for by the Food Quality Protection Act (FQPA).
When the Agency has completed the cumulative assessment, dicrotophos tolerances will be reassessed
in that light. At that time, the Agency will reassess dicrotophos along with the other organophosphate
pesticides to complete the FQPA requirements and make a final reregistration eligibility determination.
By publishing this interim decision on reregistration eligibility and requesting mitigation measures now for
the individual chemical dicrotophos, 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 finalization of the RED, that any of the determinations described in
this interim RED are no longer appropriate, the Agency will pursue appropriate action, including but not
limited to, reconsideration of any portion of this interim RED.
B. Summary of Phase 5 Comments and Responses
When making its interim reregistration decision, the Agency took into account all comments received
during Phase 5 of the OP Pilot Process. These comments in their entirety are available in the docket.
A brief summary of the comments and the Agency response is noted here.
Comments were received from four- sources: the American Bird Conservancy, the National
Agricultural Aviator Association, a crop consultant from Wisner, LA and Amvac Chemical Corporation.
The American Bird Conservancy stated that since dicrotophos is very likely to cause avian effects, use
should be cancelled. The National Ag Aviators and the private crop consultant asked that the Agency
consider the importance of dicrotophos to cotton production. Amvac Chemical asked that various
points in the risk assessment be reconsidered. All comments have been considered in depth before
reaching this regulatory decision.
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
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organophosphate. The assessment is for this individual organophosphate, and does not attempt to fully
reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food
tolerances on the basis of cumulative risk 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 dicrotophos is within its own "risk cup." In other
words, if dicrotophos did not share a common mechanism of toxicity with other chemicals, EPA would
be able to conclude today that the tolerances for dicrotophos 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
indicate that the human health risks from these combined exposures are considered to be within
acceptable levels; that is, combined risks from all exposures to dicrotophos "fit" within the individual
risk cup. Therefore, the dicrotophos tolerances remain in effect and unchanged until a full reassessment
of the cumulative risk from all organophosphates is considered.
b.
Tolerance Summary
In the individual assessment, tolerances for residues of dicrotophos in/on plant commodities [40
CFR §180.241] are presently expressed in terms of dicrotophos and its plant metabolite,
monocrotophos. The field trial data submitted to support the cottonseed and cotton gin byproducts
tolerances are adequate.
The Agency is recommending that the tolerance for residues in/on cottonseed be increased to 0.2
ppm and that tolerance for residues of dicrotophos in/on cotton gin byproducts be established at 2 ppm.
The Agency will commence proceedings to revoke the pecan tolerance; however, the establishment of
the cotton gin byproduct tolerance and raising the cottonseed tolerance will be deferred, pending the
outcome of the cumulative assessment.
Table 19. Tolerance Summary for Dicroto
Commodity
Current
Tolerance, ppm
phos
Tolerance
Reassessment*,
ppm
Comment
Tolerances Listed Under 40 CFR §180.241
cotton seed
cotton gin by-products
pecans
0.05
--
0.05
0.2
2.0
Increase because field trial data
indicate current tolerance is too
low
Tolerance to be established
propose revocation
* The term "reassessed" here is not meant to imply that the tolerance has been reassessed as required by FQPA, since
this tolerance may be reassessed only upon completion of the cumulative risk assessment of all organophosphates, as
required by this law. Rather, it provides a tolerance level for this single chemical, if no cumulative assessment was
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required, that is supported by all of the submitted residue data.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were
scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA
and, to the extent that effects in wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening
Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, dicrotophos may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
3. Labels
Provided the following risk mitigation measures are incorporated in their entirety into labels for
dicrotophos-containing products, the Agency finds that all currently registered uses of dicrotophos are
eligible for reregistration, pending consideration of cumulative risks of the organophosphates. The
regulatory rationale for each of the mitigation measures outlined below is discussed immediately after this
list of mitigation measures. These mitigation measures will reduce, but not eliminate risk; however, the
Agency believes the benefits of use outweigh the risks.
4. Mitigation for Agricultural Uses
The following mitigation is necessary to reduce risks to agricultural workers and wildlife:.
• prohibit aerial application with a phase-out so that no aerial applications after January 1, 2005,
• require engineering controls such as closed cabs and closed mixing/loading systems,
reduce total seasonal applications to 0.83 Ibs ai/A and restrict use to 0.5 Ib ai/A prior to August 1;
maximum single application rate is to remain at 0.5 Ib ai/A,
• require a 6 day re-entry interval, and
• impose a production cap limiting the amount of dicrotophos produced annually to the average of the
amount produced in the last three years (1999-2001).
D. Benefits Assessment Summary
A benefits assessment was required for dicrotophos based on worker risk and ecological risk to
birds. The entire document: "Biological Assessment of Dicrotophos Use on Cotton" dated February 7,
2002 can be found in the dicrotophos docket. This assessment is summarized here.
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Dicrotophos is mainly used to contol aphids, fleahoppers, plant bugs, thrips, and stinkbugs on
cotton. Of these pests, aphids and thrips can be controlled with a number of other pesticides.
Fleahoppers and stinkbugs are not effectively controlled by other pesticides or the alternatives are
significantly more expensive. And there are no effective alternative methods to control plant bugs.
Current average total seasonal use of dicrotophos is 0.31 to 0.39 Ib. ai/acre for these key pests.
According to USDA statistics, approximately 13% of the total acres of cotton were treated with
dicrotophos between 1994 and 1999. The US Cotton Council estimated that up to 24% of the total
acres of cotton are treated with dicrotophos based on their 2001 Survey data.
Based on current use patterns, the Agency believes that a rate of 0.3 Ib. ai/acre of dicrotophos will
provide acceptable control of the key cotton pests with minor impacts on grower yields. In some cases a
late season application of an additional 0.5 Ib. ai/acre may be necessary for difficult to control pests to
avoid yield losses. The Agency believes that cotton growers will reserve dicrotophos for difficult to
control insects such as plant bugs, stink bugs, and flea hoppers and that restricting total maximum
seasonal applications to 0.83 Ib ai/A is reasonable and will not significantly impact cotton production.
E. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the current use of
dicrotophos. Where labeling revisions are warranted, specific language is set forth in the summary tables
of Section V of this document.
1. Human Health Risk Mitigation
a. Dietary Mitigation
i) Dietary (Food)
Acute and chronic dietary risk from food alone is well below the Agency's level of concern. No
mitigation is required.
ii) Drinking Water
Drinking water risk estimates based on screening level models for ground and surface waters are
also below the Agency's level of concern. No mitigation is required for dietary risk from drinking water.
Limited monitoring data collected by the USGS are comparable to the screening level estimates
generated by the screening level modeling assessments indicating that the screening level estimates are not
conservative. Based on the limited monitoring data which showed the dicrotophos was detected
frequently at low levels in the one NAWQA study which included it as an analyte, the Agency believes
that dicrotophos may contaminate water sources. The Agency believes that elimination of aerial
applications, limiting the amount which can be applied early season, and the production cap will ensure
that dicrotophos residues in surface water do not increase significantly.
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b. Occupational Risk Mitigation
i) Agricultural Uses
The highest risks for mixer/loaders/applicators of dicrotophos are associated with aerial
applications; therefore eliminating aerial applications removes the handler scenarios of greatest concern.
Risks to mixers, loaders and applicators for aerial applications are of concern with short term MOEs of
26-220 even when engineering controls are factored into the assessment. According to USDA statistics,
most dicrotophos is currently applied by ground equipment so the aerial prohibition does not pose an
undue burden on users; for more details, see the Benefits Assessment in Section IV D.
Aerial applications are being prohibited with a phase-out. The registrant has agreed to immediately
amend their labels to inform the user that aerial applications are not to be allowed after January 1,2005.
This amendment may be in the form of a sticker which is placed on all labels to be printed after the
amendment approval until new labels requiring rate changes and other amendments are approved.
The prohibition of aerial applications should also reduce the amount of dicrotophos that will be
handled and may reduce the likelihood of intermediate exposures. Intermediate-term MOEs range from
18-140 when engineering controls are included..
For handlers involved in ground applications, the use of engineering controls such as closed
mixing/loading systems and closed cabs is necessary to reduce risks from dermal and inhalation
exposures. Mixers and loaders must use a closed system that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)], for dermal
protection. The system must be capable of removing the pesticide from the shipping container and
transferring it into mixing tanks and/or application equipment. At any disconnect point, the system must be
equipped with a dry disconnect or dry couple shut-off device that is warranted by the manufacturer to
minimize drippage to not more than 2 mL. per disconnect point.
Use at the 0.5 Ib ai/A application rate results in risks that are of concern with short term MOEs of
160 for mixer/loader and 270 for applicators and intermediate term MOEs of 110 for mixer loaders and
200 for applicators. MOEs of 300 and greater are considered to be not of concern. However, allowing
the 0.5 Ib rate is necessary for controlling certain late season pests for which there are no alternative
controls. For more details, see the benefits summary in Section IV D.
ii) Post-Application Risk
Re-entry intervals for irrigating and hand-weeding should be set at 6 days postapplication. Current
REIs are set at 2 days, however MOEs are not at the target MOE of 300 until 6 days posttreatment.
This assessment assumes the 0.5 Ib ai application rate and that workers will be exposed for 8 hours/day
which is an upper bound for some activities.
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2. Environmental Risk Mitigation
The currently registered use of dicrotophos on cotton poses acute and chronic risks to birds,
mammals and aquatic invertebrates. The mitigation measures that are expected to lower expected risks
to wildlife from use of dicrotophos on cotton are: (1) prohibit aerial applications, (2) reduce total
seasonal applications to 0.83 Ibs ai/A and restrict the amount that can be used before August 1 to 0.5 Ibs
ai/A, and (3) a production cap to ensure that dicrotophos use does not increase due to restrictions placed
on other cotton insecticides. These measures will reduce, but will not eliminate risks to wildlife from
dicrotophos use.
Eliminating aerial applications will reduce drift to wildlife areas adjacent to the field and will also
lower the amount of area which may be treated at one time. Lowering the seasonal maximum application
rate from 1.5 to 0.83 Ib ai/A and restricting the amount that can be applied prior to August 1 to 0.5 Ib
ai/A is also expected to lower exposure to avian species. Restricting the amount allowed prior to August
1 reduces the amount of dicrotophos avian species are exposed to at a time they are most vulnerable, i.e.,
during the breeding season. This mitigation allows the cotton grower to retain the 0.5 Ib ai/A rate of
dicrotophos for a single application which may be necessary for some populations of late season plant
bugs for which there are no alternative controls. For more details, see the benefits assessment in Section
IVD.
Allowing the 0.5 Ib rate results in risks that are of concern for terrestrial avian and mammalian
species as well as freshwater aquatic invertebrates. A single application of 0.5 Ib ai/A results in acute
avian RQs ranging up to 3.8 and chronic avian RQ's of up to 240. But, the reduction from three
applications at 0.5 Ib ai/A to a maximum of one application at 0.5 Ib ai/A will result in lower overall risk
to wildlife.
Capping annual production at the average of the production of the last three years ensures that
dicrotophos use will not increase dramatically when restrictions are placed on other cotton insecticides.
F. Other Labeling
hi order to remain eligible for reregistration, other use and safety information need to be placed on
the labeling of all end-use products containing dicrotophos. For the specific labeling statements, refer to
Section V of this document.
1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that address these impacts. The Endangered Species Act requires federal agencies
to ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA
puts basic toxicity and exposure data developed for REDs into context for individual listed species and
their locations by evaluating important ecological parameters, pesticide use information, the geographic
relationship between specific pesticide uses and species locations, and biological requirements and
39
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behavioral aspects of the particular species. This analysis will take into consideration any regulatory
changes recommended in this RED that are being implemented at this time. A determination that there is
a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other
measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/or the
National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3,1989) is currently being implemented on an interim basis. As part of the interim
program, the Agency has developed County Specific Pamphlets that articulate many of the specific
measures outlined in the Biological Opinions issued to date. The Pamphlets are available for voluntary
use by pesticide applicators on EPA's website at www.epa.gov/espp. A final Endangered Species
Protection Program, which may be altered from the interim program, is scheduled to be proposed for
public comment in the Federal Register in the first half of 2002.
2. Spray Drift Management
The Agency is in the process of developing more appropriate label statements for spray, and dust
drift control to ensure that public health, and the environment is protected from unreasonable adverse
effects, hi August 2001, EPA published draft guidance for label statements in a pesticide registration
(PR) notice ("Draft PR Notice 2001-X" http://www.epa.gov/ PR_Notices/#2001). A Federal Register
notice was published on August 22, 2001 (http://www.epa.gov/fedrgstr) announcing the availability of
this draft guidance for a 90-day public comment period. After receipt, and review of the comments, the
Agency will publish final guidance in a PR notice for registrants to use when labeling their products.
Until EPA decides upon, and publishes the final label guidance for spray, and dust drift,
registrants (and applicants) may choose to use the statements proposed in the draft PR notice.
Registrants should refer to, and read the draft PR notice to obtain a full understanding of the proposed
guidance, and its intended applicability, exemptions for certain products, and the Agency's willingness to
consider other versions of the statements.
For purposes of complying with the deadlines for label submission outlined in this document,
registrants (and applicants) may elect to adopt the appropriate sections of the proposed language below,
or a version that is equally protective, for their end-use product labeling.
For products applied outdoors as liquids (except mosquito adulricidesl:
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas, nontarget
crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals."
"For ground boom applications, apply with nozzle height no more than 4 feet
above the ground or crop canopy, and when wind speed is 10 mph or less at the
application site as measured by an anemometer. Use (registrant to fill in
blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572
definition for standard nozzles or VMD for spinning atomizer nozzles."
40
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On all product labels:
"The applicator also must use all other measures necessary to control drift."
Otherwise, registrants should use the following standard language:
For products that are applied outdoors in liquid sprays (except mosquito adulticidesV regardless
of application method, the following must be added to the labels:
"Do not allow this product to drift."
The Agency recognizes that the above option does not address other application types.
Registrants may therefore wish to adapt some variation of the old, and proposed new language for their
particular products, depending on their application methods.
V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation measures
outlined in Section IV and V, which include, among other things, submission of the following:
A. For dicrotophos technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact Amaris Johnson at 703-305-9542 with questions regarding generic reregistration
and/or the DCI. All materials submitted in response to the generic DCI should be addressed:
By US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Amaris Johnson Amaris Johnson
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
41
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B. For products containing the active ingredient dicrotophos. registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined
in Table [insert table number] of this document;
(4) a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); arid
(6) the product-specific data responding to the PDCI.
Please contact Karen Jones at 703-308-8047 with questions regarding product reregistration
and/or the PDCI. All materials submitted in response to the PDCI should be addressed:
By US mail: By express or courier service only:
Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)
Karen Jones Karen Jones
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
42
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of dicrotophos for the above eligible uses has
been reviewed and determined to be substantially complete. The following data gaps remain:
GL-830-7050 UV/Visible Absorption
GL-870-1300 Acute Inhalation
GL-870-3465 90 day Inhalation - rat
Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate pesticides
currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18 64FR44922-44923).
DCI requirements included acute, subchronic, and developmental neurotoxicity studies; due dates are
November, 2003. Registrant responses are under review.
2. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices and applicable policies. The MUP
labeling should bear the labeling contained in Table 20 at the end of this section.
B. End-Use Products
1. Additional Product-Specific 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. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
A product-specific data call-in, outlining specific data requirements, accompanies this interim RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Table 20 at the end of this
section.
43
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C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this Interim Reregistration Eligibility Decision document. Persons other
than the registrant may generally distribute or sell such products for 50 months from the date of the
issuance of this interim RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other factors. Refer to
"Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register, Volume 56, No. 123,
June 26, 1991.
The Agency has determined that registrant may distribute and sell dicrotophos products bearing
old labels/labeling for 26 months from the date of issuance of this interim RED. Persons other than the
registrant may distribute or sell such products for 50 months from the date of the issuance of this interim
RED. Registrants and persons other than the registrant remain obligated to meet pre-existing label
requirements and existing stocks requirements applicable to products they sell or distribute.
44
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VI. Related Documents and How to Access Them
This interim Registration Eligibility Document is supported by documents that are presently
maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2,1921 Jefferson
Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays from 8:30 am
to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of January
10,2000. 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 June 14, 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."
54
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APPENDICES
55
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CJ
C5
Tree injection
equipment
-------
APPENDIX B. DATA SUPPORTING GUIDELINE REQUIREMENTS FOR THE
REREGISTRATION OF DICROTOPHOS
REQUIREMENT
CITATION(S)
PRODUCT CHEMISTRY
New Guideline Old
Number Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
61-1 Product Identity and Composition
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
00126056,43772301
00013513, 00013814,
00126056,43772301,
00013513, 00013814,
00126056, 43772301
00115285,43772301
43772302
43772301
830.1800 62-3 Analytical Method
830.6302 63-2
Color
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
PH
Stability
Oxidizing/Reducing Action
00014001, 43772302
00013435,00115285,
43772303
00013435, 43772304
00013435,00115285,
43772305
43772306
43772307
43772309
43602301
43603202
43603203
43772309
43603204
00126056,43772310
00013435, 43603205
00115285
59
-------
REQUIREMENT
CITATION(S)
830.6315 63-15 Flammability
830.6316 63-16 Explodability
830.6317 63-17 Storage Stability
830.6319 63-19 Miscibility
830.6320 63-20 Corrosion characteristics
ECOLOGICAL EFFECTS
850.2100 71-1 Avian Acute Oral Toxicity
850.2200 71-2A Avian Dietary Toxicity - Quail
850.2200 71-2B Avian Dietary Toxipity - Duck
850.2300 71-4A Avian Reproduction - Quail
850.2300 71-4B Avian Reproduction - Duck
850.1075 72-1A Fish Toxicity Bluegill
850.1075 72-1C Fish Toxicity Rainbow Trout
850.1010 72-2A Invertebrate Toxicity
None 72-3A Estuarine/Marine Toxicity - Fish
None 72-3B Estuarine/Marine Toxicity - Mollusk
None 72-3C Estuarine/Marine Toxicity - Shrimp
None 72-4A Fish- Early Life Stage
None 72-4B Estuarine/Marine Invertebrate Life
Cycle
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Delayed Neurotoxicity - Hen
Acute Neurotoxicity Screen
90-Day Feeding - Rodent
TOXTCOLOGY
870.1100 81-1
870.1200 81-2
870.1300 81-3
870.2400 81-4
870.2500 81-5
870.2600 81-6
870.6100 81-7
870.6200 81-8
82-1A
870.3100
00115285
NA
00115285
00115285
00115285
00160000
00022923
00022923
44005502
44005501
40098001
40098001
43787901, 40098001
43603306
43739801
43603305
NA
43893901
00261098, 43893901
00261098
data gap
00261098
00261098
00261098
44943901,45170201
43759801
43980201
60
-------
REQUIREMENT
CITATION(S)
870.3150 82-1B
870.3200 82-2
870.3465 82-4
870.4100 83-1A
870.4100 83-1B
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
83-2A
83-2B
83-3A
83-3B
83-4
83-5
870.5140 84-2A
870.5375 84-2B
None 84-4
870.7485 85-1
OCCUPATIONAI
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
(Mammalian gene mutation)
General Metabolism
./RESIDENTIAL EXPOSURE
875.2100 132-1A
ENVIRONMENTAL
Foliar Residue Dissipation
FATE
None 160-5 Chemical Identity
835.2120 161-1 Hydrolysis
835.2240 161-2 Photodegradation - Water
835.2410 161-3 Photodegradation - Soil
835.2370 161-4 Photodegradation - Air
835.4100 162-1 Aerobic Soil Metabolism
835.4200 162-2 Anaerobic Soil Metabolism
835.4400 162-3 Anaerobic Aquatic Metabolism
835.4300 162-4 Aerobic Aquatic Metabolism
835.1240 163-1 Leaching/Adsorption/Desorption
61
00013441
45378201
data gap
44528802
44328401
44527802
44527801
00263684
45390701
44296101
44527802
43603301
43603302
43591401
43942001
44731001
43772301
00160823
00160824
00160825
NA
00115295,00160826
00160826
NA
NA
00160828, 00160829
-------
REQUIREMENT
CITATION(S)
163-2 Laboratory volatility
835.6100 164-1 Terrestrial Field Dissipation
835.1850 165-1 Confined Rotational Crop
None 165-4 Bioaccumulation in Fish
RESIDUE CHEMISTRY
860.1300 171-4A Nature of Residue - Plants
860.1300 171-4B Nature of Residue - Livestock
44824801
00115294,41114301
44101001
waived
44614701
44031201,43962401
860.1340
860.1340
860.1380
860.1480
OTHER
850.3020
171-4C Residue Analytical Method - Plants
171-4D Residue Analytical Method - Animals
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry
/Egg
141-1 Honey Bee Acute Contact
44750301
NA
44728501
waived
05000837, 05009353,
05001991
62
-------
APPENDIX C. BIBLIOGRAPHY FOR DICROTOPHOS
Buerger, T.D., R.J. Kendall, B.S. Mueller, T. DeVos, and B.A. Williams. 1991. Effects
of methyl parathion on northern bobwhite survivability. Environ. Toxicol. Chem. 10:527-
532.
Clinch, Palmer-Jones, and Forster. 1973. Effect on honey bees of dicrotophos and
methomyl applied as sprays to white clover. New Zealand Journal of Exper. Agriculture.
1: 97-99. (referenced incorrectly in chapter as MRID 05009353.)
Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation
of the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide
residues on plants. Environ. Toxicol. Chem. 13:1383-1391.
Flickinger, E.L., D.H. White, C.A. Mitchell, and T.G. Lamont. Monocrotophos and
dicrotophos residues in birds as a result of misuse of organophosphates in Matagorda
County, Texas. J. Assoc. Off. Anal. Chem. 67:827-828.
Grue, C.E. 1982. Response of common grackles to dietary concentrations of four
organophosphate pesticides. Arch. Environ. Toxicol. 11:617-626.
Grue, C. E. and B.K. Shipley. 1984. Sensitivity of nestlings to dicrotophos, an
organophosphate pesticide. Environ. Res. 35:454-465.
Gusey, W.F. and Z.D. Maturgo. 1973. Wildlife Utilization of Croplands. Environmental
Affairs, Shell Oil Company, Houston, Texas.
Hoerger, F. and E.E. Kenaga. 1972. Pesticide residues on plants: correlation of
representative data as a basis for estimation of their magnitude in the environment.
Environmental Quality and Safety. 1:9-28.
Hudson, R.H., R.K. Tucker, and M.A. Haegele. 1972. Effect of age on sensitivity: Acute
oral toxicity of 14 pesticides to mallard ducks of several ages. Toxicol. Appl. Pharm.
22:556-561.
Lee, P.W., SM. Stearns, H. Hernandez, W.R. Powell, and MV Naidu. 1989. Fate of
Dicrotophos in the Soil Environment. J. Agric. Food Chem. 37:1169-1174.
Mitchell, C.A., D.H. White, EJ. Kolbe, and R.C. Biever. 1984. Dicrotophos poisoning
of great-tailed grackles in Texas. J. Wildl. Dis. 20:256-257.
Stromborg, K.L., C.E. Grue, J.D. Nichols, G.R. Hepp, J.E. Hines, and H.C. Bourne.
63
-------
1988. Postfledging survival of European starlings exposed as nestlings to an
organophosphorus insecticide. 69:590-601.
— Thurman, EM, LR Zimmerman, EA Scribner, and RH Coupe, Jr. 1988. Occurrence of
Cotton Pesticides in Surface Water of the Mississippi Embayment. USGS Fact Sheet FS-
022-98.
USEPA, 1992. Pesticides in Groundwater Database, 1971 -1991, National Survey.
Office of Pesticides Programs, Washington, D.C.
USEPA, 1996. Drinking Water Regulations and Health Advisories, Office of Water,
Washington, D.C.
United States Geological Survey website: http://water.usgs.gov/nawqa/
Willis, G.H. and L.L. McDowell. 1987. Pesticide Persistence on Foliage. Rev. Environ.
Contain. Toxicol. 100:23-73.
00013435 Shell Chemical Company (19??) Bidrin Insecticide. (Unpublished study received Jan 28,
1966 under 201-142; CDL:000834-A)
00013444 Witherup, S.; Stemmer, K..L.; Schlecht, H. (1963) Specific Physiological Effects of Bidrin,
Vapona, and Ciodrin Insecticides in Chickens. (Unpublished study received Jan 28,1966
under 201-142; prepared by Univ. of Cincinnati, Dept. of Preventive Medicine and
Industrial Health, Kettering Laboratory, submitted by Shell Chemical Co., Washington,
D.C.; CDL:000834-J).
00013446 Eisenlord, G.; Loquram, G.S. (1965) Results of Reproduction Study of Rats Fed Diets
Containing Bidrin Insecticide Over Three Generations: Report No. 3. (Unpublished study
received Jan 28,1966 under 201-142; prepared by Hine Laboratories, submitted by Shell
Chemical Co., Washington, D.C.; CDL:000834-L).
00013511 Simkover, H.G.; Bishop, J.L. (1971) Bidrin/Citrus Wildlife Study. (Unpublished study
received Feb 3,1977 under 201-274; submitted by Shell Chemical Co., Washington,
D.C.; CDL:095828-G).
00013513 Shell Oil Company (1976) [Properties, Manufacturing Process, and Preparation of
Technical Bidrin]. (Unpublished study received Feb 3, 1977 under 201-274;
CDL:095828-L)
00013702 McEwen, L.C.; Haegele, M.A. (1968) Special Report: Effects on Wildlife of Rangeland
Grasshopper Control with Bidrin. (Unpublished study including letter dated Feb 15,1968
64
-------
from L. C. McEwen to Roger Didrickson, received Feb 15, 1968 under unknown admin.
no.; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center,
submitted by Shell Chemical Co., Washington, DC.; CDL:130006-A)
00013707 Gough, B.J.; Shellenberger, T.E.; Escuriex, L.A. (1967?) Acute Toxicity of a Series of
Organophosphate Pesticides to Bobwhite and Japanese Quail. (Unpublished study
received Sep 13, 1974 under 2724-169; prepared by Gulf South Research Institute,
submitted by Zoecon Industries, Inc., Dallas, Tex.; CDL: 128306-A).
00013814 Shell Chemical Company (1962) Manufacture of Bidrin Insecticide. (Unpublished study
received Jan 24, 1963 under 201-274; CDL: 000970-B)
00014001 Shell Oil Company (1970) Technical Data Bulletin: Summary of Basic Data for Bidrin
Insecticide: ACD: 62-2R. Rev. (Unpublished study received Nov 18, 1970 under
1F1062; CDL:093373-A)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
Environmental Pollutants to Birds: Special Scientific Report-Wildlife No. 191. (U.S.
Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00034732 Dix, K.M.; Wilson, A.B.; McCarthy, W.V. (1973) Toxicity Studies with Bidrin:
Teratological Studies in Rabbits Given Bidrin Orally: Group Research Report
TLGR.0020.73. (Unpublished study received Sep 12, 1975 under 6F1675; prepared by
Tunstall Laboratory and Sittingbourne Laboratories, submitted by Shell Chemical Co.,
Washington, D.C.; CDL:095989-H)
00115285 Shell Chemical Co. (1981) [Chemistry of Bidrin Dicrotophos]. (Compilation; unpublished
study received Oct 7,1982 under 201-142; CDL:248514-A)
00115294 Shell Chemical Co. (1973) Bidrin Insecticide Soil Dissipation Data. (Compilation;
unpublished study received Oct 7, 1982 under 201-142; CDL:248514-L).
00126056 Shell Chemical Co. (1962) [Chemistry of Bidrin]. (Compilation; unpublished study
received Jan 28, 1983 under 201-142; CDL: 249412-A)
00156063 Price, J. (1985) Toxicology of Insecticides: The Acute Oral and Percutaneous Toxicity,
Skin and Eye Irritancy and Skin Sensitizing Potential of Bidrin: Project No. SRCAMR85.
Unpublished study prepared by Shell Research Ltd, Sittingbourne Research Centre. 59 p.
(EPA Accession # 00261098)
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of pesticides to
wildlife: Second edition. US Fish and Wildlife Service: Resource Publication 153. 91 p.
65
-------
00160823 Steams, S.; Lee, P. (1986) Aqueous Hydrolysis of Carbon 14-SD3562:
RIR-22-002-86. Unpublished study prepared by Shell Agricultural Chemical Co. with
summary of environmental fate data appended. 26 p.
00160824 Stearns, S.; Lee, P. (1986) Aqueous Photolysis of Carbon 14-SD3562: RIR-22-003-86.
Unpublished study prepared by Shell Agricultural Chemical Co. 20 p.
00160825 Powell, W.; Hernandez, H.; Lee, P. (1986) Soil Surface Photolysis of Carbon 14-SD
3562: RIR-22-013-86. Unpublished study prepared by Shell Agricultural Chemical Co.
20 p.
00160826 Hernandez, H.; Stearns, S.; Lee, P. (1986) Aerobic Soil Metabolism of SD 3562:
RIR-22-006-86. Unpublished study prepared by Shell Agricultural Chemical Co. 26 p.
00160827 Hernandez, H.; Stearns, S.; Lee, P. (1986) Anaerobic Soil Metabolism of SD 3562:
RIR-22-011-86. Unpublished study prepared by Shell Agricultural Chemical Co. 31 p.
00160828 Steams, S.; Hernandez, H.; Lee, P. (1986) Soil Adsorption and Desorption of SD 3562:
RIR-22-001-86. Unpublished study prepared by Shell Agricultural Chemical Co. 32 p.
00160829 Hernandez, H.; Steams, S.; Lee, P. (1986) Soil Thin-layer Mobility of SD 3562 and Its
Soil Degradates: RIR-22-010-86. Unpublished study prepared by Shell Agricultural
Chemical Co. 15 p.
00161578 Koehler, S. (1986) Developmental Toxicity of Technical Bidrin Insecticide in Sprague
Dawley Rats: WIL-93006. Unpublished Shell Development Co. Project No. 61586
prepared by Wil Research Laboratories, Inc. 360 p. (EPA Accession # 00263684).
00162751 Stevenson, J. (1968) Laboratory studies on the acute contact and oral toxicities of
insecticides to honeybees. Ann. appl. Biol. 61:467-472.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide residues to four kinds of
bees. Environmental Entomology l(3):393-394.
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker honey
bees ('-Apis mellifera~L_). Plant Pathology 27(1):38-40.
05004148 Bartlett, B.R. (1964) The toxicity of some pesticide residues to adult Amblyseius hibisci'
with a compilation of the effects of pesticides upon phytoseiid mites. Journal of Economic
Entomology 57(4):559-563.
66
-------
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base
for 410 Chemicals and 66 Species of Freshwater Animals. US Fish & Wildlife Service,
Resource Publication 160. 579 p.
40873701 Palmer, D.; Krueger, H.; Jaber, M. (1988) Dicrotophos: An Evaluation of its Effects upon
Wildlife on and around Cotton Fields in Southwestern Arizona: Wildlife International Ltd
Project No. 112-181. Unpublished study prepared by Wildlife International Ltd. 345 p.
40917001 Sheeley, D.; Dingledine, J.; Krueger, H.; et al (1988) Dicrotophos: An Evaluation of Its
Effects upon Wildlife on and Around Cotton Fields in Southeastern Alabama: Proj. No.
112-180; AMR 1246-88. Unpublished study prepared by Wildlife International Ltd. 326
P-
41114301 Lee, P. (1989) Field Soil Dissipation Study with Dicrotophos: Project ID:
AMR-1189-88. Unpublished study prepared by E.I. duPont de Nemours and Co., Inc.,
and En-Cas Analytical Laboratories. 95 p.
43591401 San, R.; Clarke, J. (1995) L5178Y/TK(+/-) Mouse Lymphoma Mutagenesis Assay with
a Confirmatory Assay: Technical Dicrotophos: Final Report: Lab Project Number:
G94AW39.702001. Unpublished study prepared by Microbiological Associates, Inc. 45
P-
43603201 Braden, G. (1995) Water Solubility of BIDRIN Insecticide. Unpublished study prepared
by AMVAC Chemical Corp. 9 p.
43603202 Braden, G. (1995) Solubility of BIDRIN Insecticide in Selected Organic Solvents.
Unpublished study prepared by AMVAC Chemical Corp. 22 p.
43603203 Gonzalez, J. (1995) Vapor Pressure of BIDRIN Technical Insecticide. Unpublished
study prepared by AMVAC Chemical Corp. lip.
43603204 Gonzalez, J. (1995) Partition Coefficient (n-Octanol/Water) for BIDRIN Insecticide: Lab
Project Number: KOW 003-1. Unpublished study prepared by AMVAC Chemical
Corp. 20 p.
43603205 Gonzalez, J. (1995) Stability of BIDRIN Technical Insecticide at 50 (degrees) C: Lab
Project Number: STO-003/005. Unpublished study prepared by AMVAC Chemical
Corp. 19 p.
43603301 San, R.; Wyman, M. (1994) Salmonella Plate Incorporation Mutagenicity Assay (Ames
Test) with a Confirmatory Assay: Technical Dicrotophos: Final Report: Lab Project
Number:G94AW39.501001. Unpublished study prepared by Microbiological
Associates, Inc. 55 p.
67
-------
43603302 Putman, D.; Young, R. (1994) Micronucleus Cytogenetic Assay in Mice: Technical
Dicrotophos: Final Report: Lab Project Number:G94AW36.122. Unpublished study
prepared by Microbiological Associates, Inc. 33 p.
43603305 Jones, F.; Davis, J. (1995) Dicrotophos Technical: Acute Toxicity to the Mysid
(Mysidposis) Under FlowThrough Test Conditions: Lab Project #: J9407001G.
Unpublished study prepared by Toxikon Environmental Sciences. 48 p.
43603306 Jones, F.; Davis, J. (1995) Dicrotophos Technical: Acute Toxicity to the Sheepshead
Minnow (Cyprinodon variegatus) Under Flow-Through Test Conditions: Lab Project
Number: J9407001E. Unpublished study prepared by Toxikon Environmental Sciences.
48 p.
43759801 Rattray, N. (1995) Dicrotophos: Acute Neurotoxicity Study in Rats: Lab Project
Numbers: CTL/P/4486: AR5795: Y08547/002. Unpublished study prepared by Zeneca
Central Toxicology Lab. 259 p.
43772301 Brady, K. (1995) Product Identity and Composition of BIDRIN Insecticide.
Unpublished study prepared by AMVAC Chemical Corp. 33 p.
43772302 Brady, K. (1995) Preliminary Analysis of BIDRIN Insecticide. Unpublished study
prepared by AMVAC Chemical Corp. 11 p.
43772303 Brady, K. (1995) Color of BIDRIN Insecticide. Unpublished study prepared by
AMVAC Chemical Corp. 6 p.
43772304 Brady, K. (1995) Physical State of BIDRIN Insecticide. Unpublished study prepared by
AMVAC Chemical Corp. 6 p.
43772305 Brady, K. (1995) Odor of BIDRIN Insecticide. Unpublished study prepared by
AMVAC Chemical Corp. 6 p.
43772306 Gonzalez, J. (1995) Melting Point of BIDRIN Insecticide. Unpublished study prepared
by AMVAC Chemical Corp. 7 p.
43772307 Braden, G. (1995) Boiling Point of BIDRIN Insecticide. Unpublished study prepared by
AMVAC Chemical Corp. 11 p.
43772308 Brady, K. (1995) Density of BIDRIN Insecticide. Unpublished study prepared by
AMVAC Chemical Corp. 7 p.
43772309 Brady, K. (1995) Dissociation Constant of BIDRIN Insecticide. Unpublished study
68
-------
prepared by AMVAC Chemical Corp. 5 p.
43 772310 Braden, G. (1995) pH of BIDRIN Insecticide. Unpublished study prepared by AMVAC
Chemical Corp. 13 p.
43787901 Davis, J.; Cunningham, F. (1995) Dicrotophos Technical: Acute Toxicity to the Water
Flea (Daphnia magna) Under Flow-Through Test Conditions: Lab Project Number:
J9407001D. Unpublished study prepared by AMVAC Chemical Corp. and Toxicon
Environmental Sciences. 56 p.
43893901 Davis, J.; Cunningham, F. (1996) Dicrotophos Technical: Chronic Toxicity to the Mysid
(Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: J9407001H:
J9503013. Unpublished study prepared by Toxikon Environmental Sciences.88 p.
43980201 Homer, S. (1995) Dicrotophos: Subchronic Neurotoxicity Study in Rats: Lab Project
Number: PR0997: CTL/P/4692. Unpublished study prepared by Zeneca Central
Toxicology Lab. 329 p.
44005501 Cameron, D. (1996) Dicrotophos: Mallard Duck Dietary Reproduction and Preliminary
Studies: Lab Project Number: AVC 6: AVC 6/960138. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 259 p.
44005502 Cameron, D. (1996) Dicrotophos: Bobwhite Quail Dietary Reproduction and Preliminary
Studies: Lab Project Number: AVC 5: AVC 5/960137. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 313 p.
44296101 Moxon, M. (1997) Dicrotophos: Multigeneration Study in the Rat: Lab Project Number:
CTL/P/5129: RR0689. Unpublished study prepared by Zeneca Central Toxicology Lab.
2206 p. (Relates to L0000169, L0000025)
44328401 Homer, S. (1997) Dicrotophos: 1 Year Oral Toxicity Study in Dogs: Lab Project
Number: CTL/P/5103: PD1008. Unpublished study prepared by Central Toxicology
Lab. 606 p.
44527801 Milbum, G. (1998) Dicrotophos: Two Year Oncogenicity Study in Mice: Lab Project
Number: CTL/P/5503: PM0992. Unpublished study prepared by Zeneca Central
Toxicology Laboratory. 2481 p.
44527802 Allen, S. (1998) Dicrotophos: Two Year Dietary Toxicity and Oncogenicity Study in Rats:
Lab Project Number: CTL/P/5391:PR0986: CO/94/4533. Unpublished study prepared
by Zeneca Central Toxicology Laboratory. 3955 p.
69
-------
44943901 Frey, L.; Beavers, J.; Martin, K. et al. (1999) A Delayed Neurotoxicity Study in Laying
Hens Phase I—Acute Oral Toxicity and Evaluation of Atropine and 2-PAM Protection:
Lab Project Number: 246-111: 246/092998/CNT.I/SUB246. Unpublished study
prepared by Wildlife International Ltd. 74 p.
44956501 Hahne, R. (1999) Chronic Toxicity of Dicrotophos Technical-During the Complete
Life-Cycle of Daphnia magna Under Flow-Through Test Condititons: Lab Project
Number: 44978. Unpublished study prepared by ABC Laboratories, Inc. 46 p.{OPPTS
850.1300}
45099501 Gledhill, A. (1999) Dicrotophos: In Vivo Dermal Penetration Study in the Rat: Lab
Project Number: CO8064: Y08547/006: Y08547/008. Unpublished study prepared by
Zeneca Central Toxicology Laboratory. 102 p.
45170201 Frey, L.; Beavers, J.; Martin, K. et al. (2000) Dicrotophos: A Delayed Neurotoxicity
Study in Laying Hens Phase II-Acute Neurotoxicity Assessment: Lab Project Number:
246-112. Unpublished study prepared by Wildlife International, Ltd. 162 p. {OPPTS
870.6100}
45343601 Johnson, I, (2000) Dicrotophos: 14 Day Dermal Toxicity Study in the Rat with
Cholinesterase Determination: Lab ProjectNumber: LR0589: CTL/LR0589:
CTL/LR0589/REG/REPT. Unpublished study prepared by Zeneca Central Toxicology
Lab. 156 p.
45378201 Noakes, J. (2001) Dicrotophos: 21/28 Day Dermal Toxicity Study in Rats: Lab Project
Number: CTL/LR0588: LR0588. Unpublished study prepared by Zeneca Central
Toxicology Lab. 1173 p. {OPPTS 870.3200}
45390701 Moxon, M. (2001) Dicrotophos: Prenatal Developmental Toxicity Study in the Rabbit:
Lab Project Number: CTL/RB0865: RB0865: CTL/RB0865/REG/REPT. Unpublished
study prepared by Zeneca Central Toxicology Lab. 575 p. {OPPTS 870.3700}.
70
-------
APPENDIX D. GENERIC DATA CALL-IN
See attached table for a list of generic data requirements. Note that a complete Data Call-
in (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
71
-------
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See attached table for a list of product-specific data requirements. Note that a complete
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APPENDIX G. EPA'S BATCHING OF DICROTOPHOS PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing Dicrotophos the primary active ingredient, the
Agency has batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.).
Note the Agency is not describing batched products as "substantially similar" since some products with in
a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity data for an individual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other registrants,
or only their own products within in a batch, or to generate all the required acute toxicological studies for
each of their own products. If the registrant chooses to generate the data for a batch, he/she must use one
of the products within the batch as the test material. If the registrant chooses to rely upon previously
submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by to-
days standards (see acceptance criteria attached), the formulation tested is considered by EPA to be
similar for acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is
referenced, the registrants must clearly identify the test material by EPA Registration Number. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-in Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend
on someone else to do so. If the registrant supplies the data to support a batch of products, he/she must
select the one of the following options: Developing data (Option 1), Submitting an existing Study (Option
4), Upgrading an existing Study (Option 5), or Citing an Existing Study (Option ). If a registrant depends
on another's data, he/she must choose among: Cost sharing (Option 2), Offers to Cost Share (Option 3)
or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1, 4, 5 or 6.
95
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However, a registrant should know that choosing not to participate in a batch does not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Three products were found which contain Dicrotophos as the active ingredient. These three
are technical products (EPA Reg. Nos. 5481-447, 5481-448 and 7946-11). Therefore, acute toxicity
data on one product may support all three.
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APPENDIX H. TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of November 10,
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 June 14, 2000.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via
the Internet at the following site:
www.epa.gov/pesticides/op
These documents include:
HED Documents:
1. Dicrotophos (List A, Reregistration Case No. 0145). HED Risk Assessment for Reregistration
Eligibility Document (RED) Chemical No 035201. November 7,2001
2. Dicrotophos (List A, Reregistration Case No. 0145). HED Risk Assessment for Reregistration
Eligibility Document (RED) Chemical No 035201. DP Barcode D264754. April 5, 2000
EFED Documents:
1. EFED RED Chapter for Dicrotophos. (Chemical # 035201). October 28, 1998.
2. Revised Surface Water EECs (Incorporating the Index Reservoir and Percent Crop Area) October
24,2001.
Biological and Economic Analysis Division Documents
1. Biological Assessment of Dicrotophos Use on Cotton. February 7, 2002.
2. Dicrotophos Use on Cotton - Information Matrix of 2000 versus 2002 Responses. Appendix to the
Biological Assessment of Dicrotophos Use on Cotton from February 2002.
97
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APPENDIX L
LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out
on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information1 or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by
e-mail at williams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product.
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing.
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
httD://www.eDa.eov/oDordOO 1 /forms/8570- 1 .pdf
htrn://www.ena.eov/onnrd001/forms/8570-4.Ddf
httrj://www,eDa.eov/opprd001/forms/8570-5.pdf
htttx/Avww.eDa.EOv/oDDrdOO 1 /forms/8570- 1 7.odf
httD://www.eDa.EOv/opDrd001/forrns/8570-25.pdf
httr>://www.eDa.eov/oDDrd001/forrns/8570-27.Ddf
htro://www.eDa.Eov/oDDrd001/forms/8570-28.pdf
hrtD://www.eDa.eov/om>rd001/forms/8570-30.Ddf
httr>://www.eDa.eov/opprdOOI/forms/8570-32.pdf
99
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8570-35
8570-36
8570-37
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties
(PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice 98-1)
httD://www.ena.eov/ODDDmsdl/PR Nottces/nr98-5.cdf
tittD://www.epa.eov/or>ppmsdl/PR Notices/pr98-l .pdf
httD://www.epa.eov/ODDDmsdl/PR Notices/pr98-l .cdf
Pesticide Registration Kit
•'yww.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following pertinent
forms and information needed to register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and
Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require
the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
100
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4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat
reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
Before submitting your application for registration, you may wish to consult some additional sources of
information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United States",
PB92-221811, available through the National Technical Information Service (NTIS) at the
following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at
(800) 858-7378 or through their website: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to
be completed by OPP:
1. Date of receipt;
2. EPA identifying number; and
3. Product Manager assignment.
101
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Other identifying information may be included by the applicant to link the acknowledgment of receipt
to the specific application submitted. EPA will stamp the date of receipt and provide the EPA
identifying file symbol or petition number for the new submission. The identifying number should be
used whenever you contact the Agency concerning an application for registration, experimental use
permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind" codes
used when a sample was submitted for testing by commercial or academic facilities). Please provide
a chemical abstract system (CAS) number if one has been assigned.
102
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