United States Prevention, Pesticides EPA 738-R-00-003
Environmental Protection And Toxic Substances June 2000
A9ency (7508C)
Report on FQPA Tolerance
Reassessment Progress
and Interim Risk
Management Decision for
Chlorethoxyfos
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3:
33
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
Page 1 of 3
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(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
Page 2 of 3
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Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
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,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
| WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency has completed its review
of the available data and public comments related to the revised human health risk assessment for
the organophosphate pesticide chlorethoxyfos. The attached document entitled, "Report on
FQPA Tolerance Reassessment and Interim Risk Management Decision for Chlorethoxyfos"
summarizes the Agency's assessment of the dietary and occupational risk from chlorethoxyfos.
Based on its review, EPA has identified risk mitigation measures believed necessary to address the
human health risks associated with the current use of chlorethoxyfos. These risk mitigation
measures can be found in the attached document.
The major means by which the Agency reassesses tolerances is through its reregi strati on
process. Each pesticide registered prior to 1984 is subject to a comprehensive evaluation of its
effects on human health and the environment. Such an evaluation includes a determination of
whether the tolerances are safe. Since chlorethoxyfos was registered after 1984, it is not subject
to reregi strati on. However, chlorethoxyfos tolerances are subject to reassessment in accordance
with the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality
Protection Act of 1996 (FQPA). FQPA requires EPA to re-evaluate existing tolerances to ensure
that children and other sensitive subpopulations are protected from pesticide risk.
At the time chlorethoxyfos was registered, it was granted a conditional registration
contingent on the submission of dermal and inhalation toxicity studies and handler exposure
studies. The Agency decided, in addition to reassessing chlorethoxyfos tolerances, to conduct an
occupational risk assessment incorporating the results of the data submitted as a condition of
registration. These data have been reviewed and considered in the updated occupational risk
assessment.
The Agency has not conducted a new risk assessment for the effects of chlorethoxyfos on
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non-target species (e.g., fish and birds) since it believes that the conclusions reached at the time of
the initial decision to register chlorethoxyfos in 1995 remain unchanged.
The "Report on FQPA Tolerance Reassessment Progress and Interim Risk Management
Decision for chlorethoxyfos" is based on the revised human health assessment, updated technical
information, and public comments received by the Agency, all of which are available in the
chlorethoxyfos public docket. The docket includes both the preliminary and revised risk
assessment for chlorethoxyfos as well as comments on the risk assessments submitted by the
general public and stakeholders. The Agency did not receive comments on the revised risk
assessment or risk mitigation proposals during the Phase 5 Risk Management comment period
which ended October 18, 1999. The risk assessment and the documents supporting it are
available for viewing in the Office of Pesticide Programs Public Docket and can also be found on
the Agency's web page, www.epa.gov/pesticides/.
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 reregi strati on and/or tolerance
reassessment decisions for these pesticides. As part of the Agency's effort to involve the public in
the implementation of the FQPA, the Agency is undertaking a special effort to maintain open
public dockets on the organophosphate pesticides and to engage the public in the reregi strati on
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 which advised the Agency on implementing the new provisions of the
FQPA. The reregi strati on and tolerance reassessment reviews for the organophosphate pesticides
are following this new process.
Please note that the chlorethoxyfos risk assessment concerns only this particular
organophosphate. It does not address the cumulative effects of other organophosphates as a
class. Because FQPA directs 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 cholinesterase, the Agency
will evaluate the cumulative risk posed by the entire organophosphate class of chemicals after
completing risk assessments for individual organophosphates. While working to complete a
methodology to assess cumulative risk, the Agency has decided to move forward with individual
assessments and identify mitigation measures which the Agency believes are necessary. The
Agency will issue its final decision on chlorethoxyfos when the cumulative assessment for all
organophosphates has been completed.
End-use product labels must be revised by the manufacturer to adopt the changes set
forth in Section IV of this document. Instructions for registrants on submitting revised labeling
and the time frame established to do so can be found in section V of this document.
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If you have questions on this document or the proposed label changes, please contact the
Special Review and Reregi strati on Division representative, Deanna Scher at (703) 308-7043.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Enclosures
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Report on FQPA Tolerance Reassessment Progress
and Interim Risk Management Decision
for
Chlorethoxyfos
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Table of Contents
Executive Summary iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Pesticide 5
III. Overview of Chlorethoxyfos Human Health Risk Assessment 5
A. Dietary Risk from Food 6
1. Toxicity 6
2. FQPA Safety Factor 7
3. Dietary Exposure Assumptions 8
4. Food Risk Characterization 8
B. Dietary Risk from Drinking Water 8
1. Surface Water 9
2. Ground Water 9
3. Drinking Water Levels of Comparison 9
C. Aggregate Risk 10
D. Occupational Risk 10
1. Toxicity 10
2. Exposure 11
3. Handler Exposure Estimates 12
4. Post Application Risk 13
IV. FQPA Tolerance Reassessment Progress & Interim Risk Management Decision . . 13
A. Tolerance Reassessment Progress & Interim Risk Management Decision . 13
B. Summary of Phase 5 Comments and Revisions to the Risk Assessment ... 14
C. Regulatory Position 14
1. FQPA Assessment 14
a. "Risk Cup" Determination 14
b. Tolerance Summary 15
2. Endocrine Disrupter Effects 16
3. Required Label Modifications 16
D. Regulatory Rationale 17
V. What Registrants Must Do 19
A. Manufacturing Use Products 19
B. End-Use Products 19
1. Labeling Modifications for End-Use Products 19
2. Procedure and Timing for Label Amendment 23
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C. Existing Stocks 23
VI. Related Documents and How to Access Them 23
Appendix I. Bibliography 24
Appendix II: Pesticide Registration Kit 35
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CHLORETHOXYFOS TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Gary Bangs Reregistration Branch III
Steven Knizner Reregistration Branch III
Jess Rowland Reregistration Branch III
Environmental Fate (Drinking Water) Risk Assessment
Robert Matzner Fate and Monitoring Branch
Risk Management
Deanna Scher Reregistration Branch I
Stephanie Willett Reregistration Branch I
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
ChE Cholinesterase
CI Cation
CNS Central Nervous System
cPAD Chronic Popoulation Adjusted Dose
CSF Confidential Statement of Formula
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, non carcinogenic health effects are not anticipated to occur.
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
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
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
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.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
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.
ug/g Micrograms Per Gram
Mg/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
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MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
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
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
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.
WP Wettable Powder
WPS Worker Protection Standard
in
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Executive Summary
EPA has completed its review of available data and public comments, revised the preliminary
human health assessment, and developed the risk management measures set forth in this report. The
Agency invited stakeholders to provide proposals and suggestions on appropriate mitigation measures
before issuing its risk management decision on chlorethoxyfos, however, no risk mitigation proposals
were received. This "Report on FQPA Tolerance Reassessment Progress and Interim Risk
Management Decision" will not be considered final until the cumulative risk assessment of all
organophosphate pesticides is complete. The cumulative assessment may result in further risk
mitigation measures for chlorethoxyfos.
Chlorethoxyfos is a restricted use, organophosphate insecticide registered for use on field
corn, seed corn, sweet corn, and popcorn for the control of corn rootworms, wireworms, cutworms,
seed corn maggots, white grubs and symphylans. It was first registered in the United States in 1995
and is formulated into 2.5% and 5% granular end-use products (Fortress® 2.5G and 5G). Use is
limited to one application per year at planting, at a maximum rate of 0.1625 Ib ai/acre. Annual
domestic usage of chlorethoxyfos is estimated to range from 8,500 to 17,800 pounds active ingredient
for approximately 37,000 to 122,000 acres treated. Approximately 1% of all corn acreage is treated.
Overall Risk Summary
EPA's dietary (food) risk assessment for chlorethoxyfos indicates that neither the acute or
chronic risks exceed the Agency's level of concern, i.e., less than 100% of the acute or chronic PAD
is utilized for the general U. S. population and all population subgroups, including infants and children
at the 99.9th percentile of exposure.
Acute and chronic dietary risks from drinking water are also below the Agency's level of
concern. Surface water and ground water estimated environmental concentrations (EECs) do not
exceed the Agency's drinking water levels of comparison (DWLOC) for acute and chronic aggregate
dietary exposure. Aggregate risk, based on food and water exposure, does not exceed the Agency's
level of concern, therefore, no risk mitigation based on dietary risk estimates is necessary at this time.
The Agency has determined that there is potential exposure to handlers for use-patterns
associated with chlorethoxyfos. Occupational handler risk estimates are based on chemical-specific
dermal and inhalation exposure studies. The risks in all exposure scenarios do not exceed the
Agency's level of concern when the appropriate PPE and engineering controls are utilized during the
loading and application processes.
EPA did not quantitatively assess the risks to post application workers. Minimal post-
application exposure is anticipated since chlorethoxyfos is typically incorporated into the soil, is
applied at planting, is not systemic in the plant and degrades readily.
The Agency is requiring the following label changes which are intended to mitigate potential
occupational risk and/or better characterize risk from occupational exposure to chlorethoxyfos
products:
iv
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Labels must state that in addition to the PPE which loaders of the Fortress® 5G in the
SmartBox™ must wear (long-sleeved shirt, long pants, shoes plus socks, chemical-resistant
gloves), loaders must also have immediately available for use in case of an emergency: a
respirator with an organic-vapor removing cartridge or canister, a chemical-resistant apron,
and chemical-resistant footwear.
"Other handlers" must be specified on labels and must wear long-sleeved shirts, long pants,
shoes plus socks and chemical-resistant gloves.
A "double notification" statement must be added to end-use labels. Double notification
requires that workers be advised about the application both orally and by posting warning
signs at entrances to treated areas during the REI.
The PPE requirement for loaders of Fortress® 2.5G (coveralls over a long-sleeved shirt and
long pants) must be reduced to a long-sleeved shirt and long pants.
The use of eye protection while loading Fortress products is not required by the WPS based
on current toxicity values for the products. Registrants may continue to list eyewear as a user
recommendation at their option.
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I. Introduction
This report on the progress toward tolerance reassessment for chlorethoxyfos is the result of
the pilot process developed through the Tolerance Reassessment Advisory Committee (TRAC) to
facilitate greater public involvement in the ongoing FIFRA reregi strati on and/or FQPA tolerance
reassessment initiatives on pesticides. Since chlorethoxyfos was first registered in 1995, it is currently
not subj ect to the reregistration process, only to the requirements of FQPA. However, some history
and background on reregistration and FIFRA is included here for informational purposes and to
provide a discussion of the existing laws requiring action on pesticides.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984.
The amended act calls for the development and submission of data to support the reregistration of
an active ingredient, as well as a review of all submitted data by the EPA. 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 during reregistration. It also requires that
EPA review all tolerances in effect on the day before the date of the enactment of the FQPA by
August 2006. FQPA amends both FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA),
but does not amend any of the existing reregistration deadlines. Therefore, the Agency is continuing
its reregistration program while it resolves the remaining issues associated with the implementation
of FQPA. The Agency is also continuing its progress toward tolerance reassessment as required by
FQPA for all of the organophosphate chemicals, whether or not they are subject to the reregistration
process. While the methodology for completion of the cumulative assessment for all of the
organophosphates is being developed, individual risk assessments and risk mitigation measures, where
appropriate, are being conducted. Although not subject to the reregistration process, the individual
dietary assessment for the organophosphate chlorethoxyfos has been completed, and will be used in
the cumulative assessment of all of the organophosphate chemicals to satisfy the requirements of
FQPA. This document presents the Agency's dietary risk assessment for chlorethoxyfos, as part of
the tolerance reassessment process.
The Agency has also revised occupational risk estimates for chlorethoxyfos. Chlorethoxyfos
end-use products were conditionally registered in 1995 pending the submission of additional studies
including dermal and inhalation toxicity studies and handler exposure studies. These data have been
reviewed and considered in the updated occupational risk assessment.
As part of the EPA's effort to involve the public in the implementation of FQPA, the Agency
is undertaking a special effort to maintain open public dockets on the organophosphate pesticides and
to engage the public in the reregistration and tolerance reassessment processes for these chemicals.
The public process was discussed by TRAC, a large multi-stakeholder advisory body which advised
1
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the Agency on implementing the new provisions of the FQPA. The reregi strati on and tolerance
reassessment reviews for the organophosphates are following this new process.
Phases 1 through 4 of the pilot process address the development and refinement of the risk
assessments. Phases 5 and 6 are concerned with the development and implementation of risk
management plans and provide opportunity for the registrants, user community, and general public
to propose risk mitigation based on the revised risk assessments. During phase 6 of the process, the
Agency prepares an interim Reregi strati on Eligibility Decision (RED) Document or a Report on
FQPA Tolerance Reassessment and Interim Risk Management Decision Document, from which risk
management will be implemented. Prior to finalizing a risk management decision, the Agency
typically arranges a conference call with USD A, growers, registrants, and other interested parties
to assess the feasibility of proposed mitigation measures.
Note that there is no comment period for this document. As part of the process developed
by the TRAC, which sought to open up the process to interested parties, the Agency's risk
assessment for chlorethoxyfos has already been subject to numerous public comment periods and a
further comment period was deemed unnecessary. A Notice of Availability for this document,
however, is being published in the Federal Register.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues
for which policies need to be created. These issues were refined and developed through collaboration
between the Agency and the 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.
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In addition to the policy issues that resulted from the TRAC process, the Agency published
in the Federal Register on August 2, 1999 a draft Pesticide Registration Notice that presents EPA's
proposed approach for managing risks to occupational users from organophosphate pesticides
(www.epa.gov/pesticides/op/pr/pdf). This notice describes the Agency's approach to managing risks
to handlers and workers of organophosphate pesticides. Generally, protective measures such as
protective clothing, closed mixing and loading systems or enclosed cab equipment as well as increased
reentry intervals will be required for most uses where current risk assessments indicate a risk and such
protective measures are feasible. The draft guidance 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
document are consistent with the draft Pesticide Registration Notice.
This document consists of six sections. Section I introduces the regulatory framework for
reregi strati on and tolerance reassessment reviews for the organophosphate pesticides. Section II
provides a profile of chlorethoxyfos use patterns and usage. Section III summarizes the human health
assessment. Section IV presents the Agency's regulatory position on this chemical. Section V
summarizes the label changes necessary to implement the measures outlined in Section V and the
procedure for label amendment. Finally, Section VI provides information on how to access all related
documents.
II. Chemical Overview
A. Regulatory History
Chlorethoxyfos was first registered in the United States in 1995 for use as an insecticide. This
interim tolerance reassessment review is the Agency's first reevaluation of chlorethoxyfos since its
initial registration in 1995.
B. Chemical Identification
Chlorethoxyfos:
CH3-CH2-O S
\ II
P-O-CH-CC13
/
CH3-CH2-O Cl
• Common Name: Chlorethoxyfos
Chemical Name: O,O-Diethyl O- (1,2,2,2-tetrachloroethyl)
phosphorothioate
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Chemical Family: Organophosphate
CAS Registry Number: 54593-83-8
OPP Chemical Code: 129006
Empirical Formula: C6HnCl4O3PS
Trade and Other Names: Fortress®
• Basic Manufacturer: E.I. du Pont de Nemours & Company
A detailed discussion on the physical properties of chlorethoxyfos can be found in the
Chlorethoxyfos human health revised risk assessment: "Human Health Risk Assessment,
Chlorethoxyfos (August 6, 1999)".
C. Use Profile
The following information is based on the currently registered uses of chlorethoxyfos.
Type of Pesticide: Insecticide
Summary of Use Sites: Terrestrial food and feed crop - corn
Food: Seed corn, field corn, sweet corn, and popcorn
Nonfood: None
Residential: No residential uses
Target Pests: Chlorethoxyfos is used to control corn rootworms, wireworms, cutworms,
seed corn maggots, white grubs and symphylans.
Formulation Types Registered: A technical grade, 88% a.i, (352-553) and two granular
end-use products, Fortress® 2.5G (352-579) and 5G (352-552), 2.5% and 5% a.i.
respectively.
Method and Rates of Application:
Equipment - Applied with ground equipment (tractor-drawn planter). The 5%
formulation is only available in a SmartBox™ , which is a completely
enclosed, tamper-proof delivery system. The 2.5% formulation is
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supplied in 50 Ib. bags for open loading.
Method and Rate - Applications are made in a T-band over the row or in the furrow. Use
is limited to one application per year, at a maximum rate of 0.1625 Ib
ai/acre.
Timing - One application per year (maximum) at planting.
Use Classification: Chlorethoxyfos is a "restricted use" chemical due to acute human, avian, and
aquatic invertebrate toxicity.
D. Estimated Usage of Pesticide
Annual domestic usage of chlorethoxyfos is estimated to range from 8,500 to 17,800 pounds
active ingredient for approximately 37,000 to 122,000 acres treated. Less than 1% of all corn
acreage is treated. 90% of all use occurs in Illinois, Indiana and Ohio.
III. Overview of Chlorethoxyfos Human Health Risk Assessment
Following is a summary of EPA's human health risk findings for the organophosphate
pesticide chlorethoxyfos, as fully presented in the document, "Human Health Risk Assessment:
Chlorethoxyfos," dated August 6, 1999. The risk assessment presented here forms the basis of the
Agency's risk management decision for chlorethoxyfos.
Using relevant data, published scientific literature, and available surrogate data, the Agency
assessed the human health risks associated with using chlorethoxyfos on corn. The residue of concern
is parent chlorethoxyfos only. Although other minor metabolites were identified, these compounds
were not included in the tolerance expression or the risk assessment based on the current use pattern.
The Agency calculated human health risks from food, water, and occupational exposures. Potential
dietary exposure to chlorethoxyfos residues may occur through the consumption of corn and through
drinking water. There are no residential or other non-occupational use sites, therefore, in quantifying
aggregate risks, the Agency only considered exposures from food and drinking water. The results
of the food and drinking water analysis indicate that acute and chronic aggregate risk is below the
Agency's level of concern.
The occupational assessment for chlorethoxyfos considered exposures that could result from
handler and post-application tasks. The risks for each handler exposure scenario do not exceed the
Agency's level of concern if PPE and engineering controls are utilized during the loading and
application processes. EPA believes that there is low potential for significant post-application
exposure because chlorethoxyfos is mainly incorporated into the soil, is applied once at planting, is
not systemic in the plant, and degrades readily. The following section outlines the results of all risk
assessments for chlorethoxyfos.
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A. Dietary Risk from Food
1. Toxicity
The Agency has reviewed all toxicity studies submitted and determined that the toxicity
database is adequate to support an interim tolerance reassessment determination for all currently
registered uses. This interim determination pertains only to chlorethoxyfos alone and does not
consider the cumulative risk from all other organophosphates.
The acute toxicity profile for the active ingredient (technical) as well as the 5% a.i. granular
end-use product (Fortress® 5G) is presented in Table I.
Table I: Acute Toxicity Profile of Chlorethoxyfos
Study Type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Toxicity Category (Technical)
I
I
I
I
I
NA (non-sensitizing)
5% a.i. end-use product (Fortress® 5G)*
p*
III
II
III
IV
NA (non-sensitizing)
* DuPont cited most of the acute toxicity studies on the 5% granular formulation for the registration of Fortress® 2.5G.
According to the registrant, the major difference between these two formulations is the reduction of active ingredient
from 5.0% to 2.5%. Therefore, the toxicity of the 2.5% formulation would probably be equal or less than the 5.0%
formulation.
**An acute oral toxicity study was conducted with Fortress® 2.5G. The results of this study placed Fortress® 2.5G in
toxicity category II for acute oral toxicity.
Chlorethoxyfos has been classified as a group D chemical, not classifiable as to human
carcinogenicity based on lack of evidence of carcinogenic potential in mice and rats. Chlorethoxyfos
was non-mutagenic both in vivo and in vitro. Further details on the toxicity of chlorethoxyfos can
be found in the August 6, 1999 Human Health Risk Assessment. The toxicology endpoints selected
for the dietary risk assessment are presented in Table II.
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Table II: Summary of lexicological Endpoints for Human Dietary Risk Assessment of Chlorethoxyfos
Assessment
Acute
Dietary
Chronic
Dietary
Dose
NOAEL =
0.06
mg/kg/day
NOAEL =
0.06
mg/kg/day
Endpoint
Plasma cholinesterase
inhibition
Overall (plasma, red
blood cell and/or brain)
cholinesterase
inhibition following
subchronic and chronic
exposures
Study
Based on day 3 of a 6-
month oral study in
dogs
Based on the
combined results of the
90-day, 6-month and 1-
year feeding studies in
dogs
UF
100
100
FQPA
Safety
Factor
IX
IX
aPAD/cPAD*
0.0006
mg/kg/day
0.0006
mg/kg/day
*The population adjusted dose (PAD) is a term that reflects the Reference Dose (RfD), either acute or chronic, adjusted
to account for the FQPA safety factor.
Typically, a rat study rather than a dog study is used to determine the acute dietary endpoint.
In the acute neurotoxicity study in rats, a NOAEL could not be established for the principal effect
because cholinesterase inhibition was seen in both sexes at the lowest dose tested at the 1-day
measurement. Inhibition at the lowest dose is a concern since chlorethoxyfos is a potent
cholinesterase inhibitor with a steep dose response curve. If the LOAEL (0.25 mg/kg/day) from the
rat study is used to derive the aPAD, then an additional uncertainty factor of 3 must be applied due
to the lack of a NOAEL, which would result in a total uncertainty factor of 300 (i.e., lOx for inter
species extrapolation, lOx for intra-species variation, and 3x for the use of LOAEL). The resulting
aPAD would be: 0.25 mg/kg/day (LOAEL)-300 (UF) = 0.0008 mg/kg/day. The aPAD calculated
using the NOAEL from the dog study was calculated to be 0.0006 mg/kg/day. Since there is
essentially no difference between the two aPADs, it is better to use a study with a NOAEL rather than
a study with a LOAEL and additional factors. In addition, a species sensitivity difference with rats
and dogs was not demonstrated for chlorethoxyfos in acute, subchronic or chronic studies. These
are the reasons why EPA selected the dog study over the rat acute neurotoxicity study.
2. FQPA Safety Factor
An uncertainty factor of 100 (the standard uncertainty factor) to account for both interspecies
extrapolation and intraspecies variability was applied to both acute and chronic dietary risk
assessments. The 10X FQPA Safety Factor was reduced to IX because; 1) there was no evidence
of increased susceptibility of rat or rabbit fetuses following in utero exposure in prenatal
developmental toxicity studies, 2) no offspring toxicity was seen at the highest dose tested in the
two-generation reproduction toxicity study and there was no evidence of abnormalities in the
development of the fetal nervous system in these studies and, 3) adequate data and modeling outputs
are available to satisfactorily assess dietary exposure and to provide a screening level drinking water
exposure assessment. The Agency believes that the assumptions and models used in the assessments
do not underestimate the potential risk for infants and children.
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3. Dietary Exposure Assumptions
Revised dietary risk analyses for chlorethoxyfos were conducted using the Dietary Exposure
Evaluation Model (DEEM™). DEEM™ incorporates consumption data generated in USDA's
Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-91.
The acute dietary risk analysis was conducted with anticipated residues set at /^ the limit of
detection (0.005 ppm) and 1% crop treated. This Tier 3 probabilistic analysis reports risk at the
99.9th percentile of exposure. One-half the limit of detection was used for chlorethoxyfos because
field trials showed no residues (<0.01 ppm) of parent in any of the corn raw agricultural commodities
analyzed, even after treatment at a lOx rate. Due to the lack of significant residues in the corn field
trials and animal metabolism studies, tolerances are not required at this time for residues in milk and
livestock tissues1.
For the chronic dietary risk assessment, the three-day average of consumption for each sub-
population was combined with the tolerance-level residue value (0.01 ppm) to determine average
exposure. A Tier 2 chronic risk assessment was conducted using 1% percent crop treated.
4. Food Risk Characterization
The acute and chronic PAD for chlorethoxyfos is 0.0006 mg/kg. The chlorethoxyfos acute
dietary risk from food is well below the Agency's level of concern. For the most exposed subgroup,
children (1-6 years), the % aPAD value is 2% at the 99.9th percentile of exposure. Similarly, the
chronic dietary risk from food is well below the Agency's level of concern. For the most exposed
subgroups, (children 1-6 years and < 1 year), the % cPAD value is 0.1%. In summary, both acute
and chronic dietary exposure and risk associated with chlorethoxyfos-treated foods are considered
to be negligible (see Table III). Therefore, further refinements to the dietary analyses are not
warranted at this time.
Table III. Risk Estimates as a Percentage of the Acute and Chronic PAD (% PAD)
Subgroups
U.S. Population
Non-nursing Infants
(less than 1 year old)
Children, 1-6 years old
Acute Tier 3 Probabilistic
Assessment*
0.5%
0.2%
2.0%
Chronic Tier 2 Assessment
<0.1%
0.1%
0.1%
99.9th percentile of exposure
B. Dietary Risk from Drinking Water
Exposure to pesticides through drinking water can occur through ground water and surface
water contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
1 For a complete listing of chlorethoxyfos tolerances, see Section IV of this document.
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and uses either modeling or actual monitoring data, if available, to estimate those risks. The residue
of concern in drinking water is the parent only. Based on environmental fate data, chlorethoxyfos
is moderately persistent in water and soil and is not expected to be mobile in soil.
To determine the maximum allowable contribution of treated water allowed in the diet, EPA
first looks at how much of the overall allowable risk is contributed by food, then determines a
"drinking water level of comparison" (DWLOC). The DWLOC is the maximum concentration of
chlorethoxyfos in drinking water which does not exceed a level of concern when considered together
with dietary exposure from food alone. Since there are no residential risks associated with
chlorethoxyfos use, only the dietary risk from food is considered for purposes of calculating the
DWLOC.
No water monitoring data are available for chlorethoxyfos. Therefore, the surface and ground
water assessments are based on modeling predictions. Modeling is considered to be an unrefined
assessment and provides a high end estimate of risk. Ground water modeling with SCI-GROW and
surface water modeling with PRZM-EXAMS were used to calculate drinking water estimated
concentrations which were then compared to the DWLOC.
1. Surface Water
Upper-bound drinking water concentrations from surface water were estimated with PRZM-
EXAMS, a Tier 2 model. This model, although considered screening level, is based on more refined
assumptions than the Tier IGENEEC model. Table IV lists the modeling results for chlorethoxyfos
in surface water based on the two current application methods.
TABLE IV. PRZM-EXAMS Modeling Results for Chlorethoxyfos in Surface Water
Application Method
In-Furrow
T-Band
Acute (High) Concentration (ppb)
0.064
0.427
Chronic (60-day) Concentration (ppb)
0.012
0.080
2. Ground Water
Drinking water concentrations from ground water were estimated with SCI-GROW, a Tier
1 assessment tool. For ground water, the maximum acute and chronic estimated concentration of
chlorethoxyfos is 0.002 ppb. This screening level model does not provide different values for acute
and chronic estimated residue levels.
3. Drinking Water Levels of Comparison (DWLOCs)
The acute and chronic DWLOC is 21 ppb for the US population and 6 ppb for children 1-6,
the most sensitive population. The acute and chronic estimated concentrations in surface and ground
water result in potential exposures that are below the Agency's level of concern.
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C. Aggregate Risk
Aggregate risk consists of the combined risk from exposure through food, drinking water,
residential, and non-occupational uses of a pesticide. For chlorethoxyfos, acute and chronic
aggregate risk is limited to food and water exposure because chlorethoxyfos is not used in residential
settings or other areas that are frequented by the general public. Generally, the combined risks from
these different exposures must be less than 100% of the acute or chronic PAD, respectively. Since
the ground and surface water estimated concentrations are substantially below the DWLOCs based
on screening models, acute and chronic aggregate (food and water) exposure to chlorethoxyfos is not
of concern for any population sub-group.
D. Occupational Risk
Occupational workers may be exposed to a pesticide through tasks such as mixing, loading,
applying a pesticide, or re-entering a treated site. EPA estimates handler risk by evaluating
occupational exposure levels, including both dermal and inhalation exposures, against the NOAEL
demonstrated in animal studies. The ratio of the estimated exposure to the NOAEL is referred to as
the Margin of Exposure (MOE). For chlorethoxyfos, MOEs greater than 100 do not exceed the
Agency's level of concern.
1. Toxicity
With the exception of the intermediate-term inhalation assessment, route-specific toxicity
studies were available and used to select the endpoints. The toxicology endpoints selected for the
occupational risk assessment are presented in Table V.
Table V: Toxicology Endpoints Selected for Occupational Risk Assessment
Assessment
Short Term (1-7 days)
Intermediate Term
(7 days - several months)
Short Term (1-7 day)
Intermediate Term
(7 days - several months)
Exposure
Route
Dermal
Dermal
Inhalation
Inhalation
Dose
Dermal NO AEL = 1.25
mg/kg/day
Dermal NO AEL = 1.25
mg/kg/day
Inhalation NOAEL =
0.00058 mg/L (0.13
mg/kg/day)
Oral NOAEL = 0.06
mg/kg/day
Endpoint
RBC
cholinesterase
inhibition (ChEI)
RBCChEI
Plasma, RBC,
and brain ChEI
Plasma ChEI
Study
21 -day dermal
toxicity study in rats
21 -day dermal
toxicity study in rats
7-day inhalation
study in rats*
6-month oral study
in dogs**
*The inhalation study duration is only 7 days and is therefore not appropriate for use as an endpoint in the intermediate
term inhalation assessment.
**Since an oral NOAEL was selected, the use of a 100% (default) inhalation absorption rate is required.
10
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2. Exposure
Chlorethoxyfos is not expected to be used on a continuous long-term basis (greater than 6
months a year) resulting in chronic exposure. Therefore, the risk assessments were conducted for
short- (1-7 days) and intermediate- (one week-several months) term occupational exposure scenarios.
EPA has determined that there are potential exposures to loaders, applicators, and other handlers
for use-patterns associated with chlorethoxyfos. The major exposure scenarios
identified for chlorethoxyfos are:
1) loading the granular formulation for ground equipment application
2) applying the granular formulation with ground equipment (tractor drawn planter)
Chemical-specific exposure studies were available for chlorethoxyfos. Anticipated use
patterns and application methods were derived from current labeling. The maximum label rate of
0.1625 Ib ai/acre and the maximum corn-planting rate estimate of 180 acres/day were assumed. This
planting estimate is based on the use of a 12- to 15-row planter set for 30-inch wide rows. The
Agency also applied standard assumptions (average body weight, hours in a work day, etc.).
Handler exposure estimates were derived from the chemical-specific studies only, which
included the use of PPE and engineering controls. Loader exposure to Fortress® 5G in the
SmartBox™ is based on the use of a long-sleeved shirt, long pants, shoes plus socks and chemical
resistant gloves. Loader exposure to Fortress® 2.5G is based on wearing coveralls over long-sleeved
shirt, long pants, shoes plus socks and chemical resistant gloves, plus an organic vapor removing
respirator with pesticide prefilter or pesticide canister. Loader exposure to Fortress® 2.5G without
coveralls was also calculated. Applicator risk from Fortress® 2.5G and Fortress® 5G is based on the
use of a closed-cab tractor while wearing baseline PPE (long-sleeved shirt, long pants, shoes plus
socks).
The level of protection employed in the handler exposure assessment is comparable to what
is currently on chlorethoxyfos end-use labels. A summary of the PPE and engineering control
requirements on current labels is provided in Table VI.
Table VI: PPE and Engineering Controls on Current Chlorethoxyfos Labels
Formulation
Fortress® 5G in
the
SmartBox™
Fortress® 2.5G
in 50 Ib. bags
Loaders
Long-sleeved shirt and long pants,
shoes plus socks, chemical resistant gloves, protective
eyewear.
Coveralls, long-sleeved shirt and long pants, shoes plus
socks, chemical resistant gloves, protective eyewear, an
organic vapor equipped with either an organic vapor-
removing cartridge or canister.
Applicators
Closed cab. Long-sleeved shirt
and long pants, shoes plus socks.*
Closed cab. Long-sleeved shirt
and long pants, shoes plus socks. *
* More protective PPE is required on labels for applicators who must exit the cab to repair or adjust the planter.
11
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3. Handler Exposure Estimates
A summary of exposure estimates for occupational handlers is included in Tables VII, VIII
and IX. For chlorethoxyfos, MOEs greater than 100 do not exceed the Agency's level of concern.
Table VII. Occupational Handler Exposure Estimates and Risk Assessment Summary: Fortress
5G in the SmartBox™
Scenario/Rate
Application
Scenario
Loader a- using a
SmartBox™
Applicator -closed-
cab tractor
Combined11
(Ib
ai/day)
29.25
29.25
29.25
Dermal
UEb
mg/lb a.i.
0.0002
0.00081
0.0010
ADDC
(mg/kg/day)
0.000084
0.00034
0.00042
Short-& interm.-
term MOEd
15,000
3,700
3,000
Inhalation
UEe
mg/day
9.6X10'5
0.0019
0.0020
ADDf
(mg/kg/day)
1.4 X10'6
2.7 X10'5
2.8 X10'5
Short-term
MOEd
93,000
4800
4600
Interm.-term
MOEd
43,000
2200
2100
Combined MOE
MOE Total8
Short-term 13,000
Interm.-term 11,000
Short-term 2100
Interm-term 1400
Short-term 1800
Interm.-term 1200
* Loader exposure reflects closed system (SmartBox™), long sleeve shirt and long pants, shoes, socks, and chemical resistant gloves. Applicator exposure
reflects long sleeve shirt, long pants, and shoes with socks.
b UE = Dermal Unit Exposure is the amount of exposure measured in terms of mg a.i./lb a.i handled
0 ADD(mg/kg/day) [dermal]: = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 Ib a.i./day / 70 kg wt;
dMOE = NOAEL/ADD; For Dermal (short-,& intermediate-term time periods)-NOAEL= 1.25mg/kg/day; For short-term inhalation-NOAEL=0.13
mg/kg/day(Based on 7-day inhalation study); For intermediate-term inhalation-NOAEL =0.06 mg/kg/day (based on an oral study, assume 100%
absorption). Inhalation NO AEL= 0.13 mg/kg/day =0.000508 mg/lX (10.31/hrsprague-Dawley inhalation rate)X( rat exposed 6hrs/day) divided by 0.236
kg (Sprague-Dawley rat body weight).
" UE = The Inhalation Unit Exposure factor is based on the respiratory rate of 29 liters/minute. Loader exposure was 0.25 hours/day (=435 liters);
applicator 7.75 hours/day (=13,485 liters). UE (loader) =(0.22 nanograms ai /liter) X (1 X10'6mg/nanogram) X 4351iters/day = 9.6X10'5 mg/dav; UE
(applicator) =(0.14 nanograms ai/liter) X (1 X10"6mg/nanogram) X 13,485 liters/day= 0.0019 nig/day.
f ADD(mg/kg/day) [inhalation] = UE is divided by avg body weight for ADD: mg/day / 70kg = mg/kg/day (The total dose).
8 MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs: 1 / (l/MOEdemlal +
l/MOE-mhatslioa ); these MOEs have a common endpoint. ' = Short-term, and2 = intermediate-term
h Loader/Applicator = 1 person performing both loading and application of the pesticide to the crop/commodity.
These estimates are based on data from a study (MRID#443998-02) which used 3.25 Ib. product/acre (equivalent to 0.1625 Ib a.i./acre)
Table VIII. Occupational Handler Exposure Estimates and Risk Assessment Summary:
Fortress 2.5G Granules with Single Layer Body Protection
Scenario/Rate
Application
Scenario
Loader" (without
coveralls)
Applicator in a
closed-cab tractor
Combined
(Ib ai/day)
29.25
29.25
29.25
Dermal
(With baseline PPE plus gloves)'
UEb
(mg/lb a.i.)
0.0023
0.0025
0.0048
ADDC
(mg/kg/day)
0.00096
0.00 10
0.0020
MOEd
1300
1200
620
Inhalation
(With OV respirator for loader)
UEe
(mg/day)
0.001
0.0047
0.0057
ADDf
(mg/kg/day)
1.4E-05
6.7 E-05
8.1E-05
Short-term
MOEd
9300
1900
1600
Interm.-term
MOE
4300
900
740
Combined MOE
MOE Total8
Short-term 1100
Interm.-term 1000
Short-term 740
Interm.-term 510
Short-term 450
Interm.-term 340
* The PPE for loaders is calculated with organic vapor removing respirator, long sleeve shirt, long pants, shoes, socks, and chemical resistant gloves
The minimum PPE for applicators in the cab is long sleeve shirt, long pants, and shoes with socks.
bUE = Unit Exposure is the amount of exposure measured in terms of mga.i./lb a.i handled
°ADD(mg/kg/day): = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 Ib a.i./day / 70 kg wt;
dMOE = NOAEL/ADD
" UE = Unit Exposure for inhalation is based upon air sampling data and is expressed in terms of nanograms (mgx 10-6) of ai per liter of air respired.
f ADD(mg/kg/day) [inhalation] = The UE factor is multiplied by the respiratory rate of 29 liters/minute. Loader exposure was 0.3 hours/day; applicator
7.7 hours. The total dose is divided by avg body weight for ADD: [(nanogram/liter * liter/min * minutes) / 70kg]
8 MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs:
1 / (1/MOEj^.j + l/MOE-mhatslioa ); these MOE have a common endpoint
The study data this is based on used 5.5 Ib of product with 5%ai, equal to 0.275 Ib ai/acre ; data were adjusted to current label application rate of 6.5
Ib. product/acre (equivalent to 0.1625 Ib a. i./acre).
12
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Table IX. Occupational Handler Exposure Estimates and Risk Assessment Summary: Fortress
2.5G Granules with Double Layer Body Protection
Scenario/Rate
Application
Scenario
Loader" (with
coveralls)
Applicator using a
closed-cab tractor
Combined
Ib ai/day
29.25
29.25
29.25
Dermal
(With Coveralls)"
UEb
(mg/lb a.i.)
0.0016
0.0017
0.0033
ADDC
(mg/kg/day)
0.00066
0.00071
0.0014
MOEd
1900
1800
910
Inhalation
(With OV respirator for loader)
UEe
(mg/day)
0.001
0.0047
0.0057
ADDf
(mg/kg/day)
1.4E-05
6.7 E-05
8.1 E-05
Short-term
MOEd
9300
1900
1600
Interm.-term
MOE
4300
900
740
Combined MOE
MOE Total8
Short-term 1600
Interm.-term 1300
Short-term 920
Interm.-term 600
Short-term 580
Interm.-term 410
" The PPE for loaders is calculated with organic vapor removing respirator, coveralls over long sleeve shirt, long pants, shoes, socks, eye protection, and
chemical resistant gloves
The PPE for applicators is calculated here with coveralls over long sleeve shirt, long pants, and shoes with socks.
b UE = Unit Exposure is the amount of exposure measured in terms of mg a.i./lb a.i handled.
°ADD(mg/kg/day): = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 Ib a.i./day / 70 kg wt;
dMOE = NOAEL/ADD
eUE = Unit Exposure for inhalation is based upon air sampling data and is expressed in terms of nanograms (mg x 10-6) of ai per liter of air respired. f
ADD(mg/kg/day) [inhalation] = The UE factor is multiplied by the respiratory rate of 29 liters/minute. Loader exposure was 0.3 hours/day; applicator
7.7 hours. The total dose is divided by avg body weight for ADD: [(nanogram/liter * liter/min * minutes) / 70kg]
8 MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs: 1 / (l/MOEiclmat +
l/MOE-mtatllioa ); these MOEs have a common endpoint
The study data this is based on used 5.5 Ib of product with 5% ai, equal to 0.275 Ib ai/acre ; data were adjusted to current label application rate of 6.5
Ib. product/acre (equivalent to 0.1625 Ib a. i./acre).
4. Post Application Risk
The Agency did not quantitatively assess the risks to postapplication workers. EPA believes
that there is low potential for significant post-application exposure since chlorethoxyfos is mainly
incorporated into the soil, is applied once at planting, degrades readily, and is not systemic in the
plant.
The restricted-entry interval (REI) is the time immediately after a pesticide application when
entry into the treated area is limited. The REI on chlorethoxyfos end-use products is 48 hours (or
72 hours where average rainfall is less than 25 inches per year).
IV. FQPA Tolerance Reassessment Progress & Interim Risk Management Decision
A. Tolerance Reassessment Progress & Interim Risk Management Decision
This interim evaluation presents the Agency's current position on products containing the
active ingredient chlorethoxyfos. The Agency has sufficient information on the human health effects
of chlorethoxyfos to make interim decisions as part of the tolerance reassessment process under
FQPA. Based on its current evaluation of chlorethoxyfos alone, the Agency has determined that
chlorethoxyfos products, labeled and used as specified in this document, will not present unreasonable
dietary and occupational adverse effects.
13
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The Agency will finalize the decision for chlorethoxyfos after evaluating the cumulative risk
of the organophosphate class. Because the Agency has not yet completed the cumulative risk
assessment for the organophosphates, this interim decision does not fully address the reassessment
of the existing chlorethoxyfos food residue tolerances as required by section 408(q) of the Food
Quality Protection Act. When the Agency has completed the cumulative assessment, chlorethoxyfos'
tolerances will be reassessed along with the other organophosphate pesticides and a final
determination will be made. Such an incremental approach to the tolerance reassessment process is
consistent with the Agency's goal of improving the transparency of the implementation of FQPA.
By evaluating each organophosphate in turn and identifying appropriate risk reduction measures, the
Agency is addressing the risks from the organophosphates in as timely a manner as possible.
This interim evaluation does not limit the Agency from making further Food Quality
Protection Act determinations and tolerance-related rulemakings that may be required on this
pesticide or any other in the future. If the Agency determines, as a result of this later implementation
process, that any of the determinations described in this Report on FQPA Tolerance Reassessment
Progress and risk management document are no longer appropriate, the Agency will pursue
appropriate action, including but not limited to, reconsideration of any portion of this interim
document.
B. Summary of Phase 5 Comments and Revisions to the Risk Assessment
The availability of the revised risk assessment and supporting documents was announced
on August 18, 1999 in Federal Register Notice 64 FR 44921. Interested parties were provided a 60
day period to submit comments, including risk mitigation proposals. No submissions were received
during this public comment period.
After the revised risk assessment was made available, calculation errors in the handler
exposure estimates with the Fortress® 2.5G product were corrected by adjusting the actual study rate
of application (5.5 Ib product at 5% ai/A=0.275 Ib ai/A) to that on the current label (6.5 Ib at 2.5%
ai/A = 0.1625 Ib ai/A). The study rate was reduced by 1.8x. MOEs are not significantly different
from prior estimates of exposure. Loader exposure to Fortress® 2.5G without the addition of
coveralls (a 50% protection factor) was also calculated after the revised assessment was made
available. The new calculations are included in Section III of this document.
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this individual organophosphate. FQPA also requires the Agency to consider available information
on cumulative risk from substances sharing a common mechanism of toxicity, such as the toxicity
14
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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 chlorethoxyfos is within its own "risk cup."
In other words, if chlorethoxyfos did not share a common mechanism of toxicity with other
chemicals, EPA would be able to conclude today that the tolerances for chlorethoxyfos on corn meet
the FQPA safety standards. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as chronic and acute food
exposure. An aggregate assessment was 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 chlorethoxyfos "fit" within the individual risk cup. Therefore, the chlorethoxyfos tolerances remain
in effect and unchanged until a full reassessment of the cumulative risk from all organophosphates is
completed.
b. Tolerance Summary
Established tolerances for residues of chlorethoxyfos in/on plant commodities are currently
expressed in terms of residues of chlorethoxyfos per se. Based upon the lack of chlorethoxyfos
residues measured in field corn, popcorn, and sweet corn commodities (<0.01 ppm) and the results
of the goat metabolism study, finite transfer of chlorethoxyfos residues is not expected to meat, fat,
meat byproducts, milk, or eggs. Therefore, no tolerances on meat, fat, meat byproducts, milk, or
eggs are necessary. Residues of chlorethoxyfos are not expected to be detectable (<0.01 ppm, limit
of quantitation for each) in corn grain, corn forage and stover as a result of soil application. There
are no CODEX, Canadian, or Mexican limits established for chlorethoxyfos, therefore, no
compatibility problem exists.
This summary provides the tolerance levels for chlorethoxyfos [O,O-diethyl (1,2,2,2-
tetrachloroetyl) ester], as supported by submitted residue data. Sufficient data are available to
ascertain the adequacy of the established tolerances for the following commodities, as defined in 40
CFR § 180.486. Based upon these data, the established tolerances do not need to be amended at this
time. Note that these tolerances cannot be considered "reassessed", as required by FQPA, until the
cumulative risk assessment of all organophosphates is completed.
15
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Table X: Tolerance Summary for Chlorethoxyfos
Commodity
Corn, field, forage
Corn, field, grain
Corn, field, stover (fodder)
Corn, pop, grain
Corn, pop, stover (fodder)
Corn, sweet (K + CWHR)
Corn, sweet, forage
Corn, sweet, stover (fodder)
Parts per million
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
2. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether certain substances
(including all pesticides and inerts) "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 recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system.
EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential effects in
wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife
evaluations. As the science develops and resources allow, screening of additional hormone systems
may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP
have been developed, chlorethoxyfos may be subject to additional screening and/or testing to better
characterize effects related to endocrine disruption.
3. Required Label Modifications
The regulatory rationale for each risk management measure outlined below is discussed
immediately after this section.
The following measures, in addition to the existing label requirements, are intended to clarify
and strengthen the existing label language to help ensure that no risk will occur from proper use.
• Labels must state that in addition to the PPE that loaders of the Fortress® 5G in the
SmartBox™ must wear (long-sleeved shirt, long pants, shoes plus socks, chemical resistant
gloves), loaders must also have immediately available for use in case of an emergency: a
respirator with an organic-vapor removing cartridge or canister, a chemical resistant apron,
and chemical resistant footwear.
16
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• "Other handlers" must be specified on labels and must wear long-sleeved shirts, long pants,
shoes plus socks and chemical-resistant gloves.
• A "double notification" statement must be added to end-use labels. Double notification
requires that workers are advised about the application both orally and by posting warning
signs at entrances to treated areas during the REI.
The following label changes are intended to better characterize risk from occupational exposure to
chlorethoxyfos products:
The PPE requirement for loaders of Fortress® 2.5G (coveralls over a long-sleeved shirt and
long pants) must be reduced to a long-sleeved shirt and long pants.
The use of eye protection while loading Fortress products is not required by the WPS based
on current toxicity values for the products. Registrants may continue to list eyewear as a user
recommendation at their option.
D. Regulatory Rationale
Dietary (Food) Risk Mitigation
The Agency is not proposing mitigation for acute or chronic dietary food risks. The current
risks are not of concern based on the acute and chronic DEEM models.
Dietary (Water) Risk Mitigation
The Agency is not proposing mitigation for acute or chronic drinking water risks. Current
risks are not of concern based on the comparison of the DWLOC against the estimated concentrations
from surface and ground water modeling.
Aggregate (Food + Water) Risk Mitigation
For chlorethoxyfos, the aggregate risk is limited to food and water. No risk mitigation for
aggregate risk is necessary at this time because food and drinking water estimates indicate that the
Agency's level of concern is not exceeded for any subgroup.
Handler Risk Mitigation
Chlorethoxyfos end-use products were conditionally registered in 1995 pending the
submission of additional studies needed to refine the Agency's risk assessments. The Agency is now
requiring changes, less stringent measures in some cases, to the labeling than was required in 1995.
• Loaders using a closed system (i.e. the SmartBox™ system) must have personal protective
equipment immediately available for use in case the system fails in accordance with the
Worker Protection Standard. Current chlorethoxyfos labels do not state this requirement.
17
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The Agency recognizes that no system is fail-safe, therefore, in addition to the PPE that
loaders of the Fortress® 5G in the SmartBox™ must wear (long-sleeved shirt, long pants,
shoes plus socks, chemical resistant gloves), loaders must also have immediately available for
use in case of an emergency: a respirator with an organic-vapor removing cartridge, a
chemical-resistant apron, and chemical resistant footwear.
• On current chlorethoxyfos labels, PPE and engineering controls are only specified for loaders
and applicators. However, there are other handler tasks which involve direct contact with the
material, for example, cleaning, adjusting or repairing parts of the loading or application
equipment, disposing of pesticide containers, performing tasks as a crop advisor, or assisting
loaders and applicators in their tasks. Handlers may also have contact with residues on
application equipment during corn seed loading. Therefore, the Agency is requiring that
"other handlers" must wear a long-sleeve shirt, long pants, shoes plus socks and chemical-
resistant gloves.
Loaders of Fortress® 2.5G must currently wear coveralls over a long-sleeved shirt and long
pants. However, the MOEs in the handler exposure assessment indicate that the risk to
loaders of the Fortress® 2.5G wearing baseline PPE (long-sleeved shirt and long pants) is still
well below the Agency's level of concern. In addition, double layers are typically required
when the end-use product is in toxicity category I for acute dermal toxicity or skin irritation
potential. Fortress® 5G is in toxicity category III for acute dermal toxicity and toxicity
category IV for dermal irritation. Based on the results of the exposure assessment, the
toxicity categories of the end-use products and the fact that coveralls worn over a long-
sleeved shirt and long pants may result in heat stress, the Agency recommends that the double
layer body protection requirement for loaders of Fortress® 2.5G be reduced to single layer
body protection.
The use of eye protection while handling Fortress products is not required by the WPS based
on current toxicity values for the products (tox. cat. Ill for eye irritation). Registrants may
continue to list eyewear as a user recommendation at their option.
Post Application Risk Mitigation
The Agency is requiring post-application risk mitigation that varies from what is currently on
the labels:
• The active ingredient chlorethoxyfos is classified as toxicity category I for both acute dermal
and primary skin irritation. Either of these classifications triggers the requirement to notify
workers about the application both orally and by posting warning signs at the entrances to
treated areas. Therefore, each product label must bear the statement, "Notify workers of the
application by warning them orally and by posting warning signs at entrances to treated
areas".
18
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Other Considerations
Although the inhalation MOEs for loaders of Fortress® 2.5G are relatively high with the use
of an organic-vapor removing respirator (short-term MOE = 9,300, intermediate term MOE
= 4,300), the requirement for an organic-vapor removing respirator remains necessary. The
product essentially behaves as a fumigant (vapor pressure = 1.7 x 10 "3) during the loading
process, probably due to vapor trapped in the head-space of the bag. Significant volatilization
of the formulation was apparent during loading in the registrant-submitted study (MRID
42559222) and constituted 50% of total exposure to the loader. Consequently, the Agency
believes it is imperative that a loader wear an approved organic vapor removing respirator,
rather than a dust/mist respirator during the loading process.
Post application risk estimates were not quantitatively calculated. EPA believes that there
is low potential for significant post-application exposure because chlorethoxyfos is mainly
incorporated into the soil, is applied once at planting, is not systemic in the plant, and
degrades readily. The restricted-entry interval (REI) is the time immediately after a pesticide
application when entry into the treated area is limited. The current WPS-established REI on
chlorethoxyfos end-use products of 48 hours or 72 hours where average rainfall is less than
25 inches per year will be retained.
V. What Registrants Must Do
A. Manufacturing Use Products
The generic data base supporting the registration of chlorethoxyfos for use on corn has been
reviewed and determined to be substantially complete.
B. End-Use Products
1. Labeling Modifications for End-Use Products
Label changes are necessary to implement the measures outlined in Section IV above.
Specific language to implement these changes is detailed in Table XI.
19
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Table XI: Summary of Labeling Changes for Chlorethoxyfos
Description
I
Required Labeling
| Placement on Label
End Use Products Intended for Use on Corn
PPE Requirements* for
the granular product in
a SmartBox™ system
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant insert correct material).
If you want more options, follow the instructions for category [insert A,B,C,D,E,F,G,or H] on an
EPA chemical-resistance category selection chart.
Loaders, applicators and other handlers must wear:
~ Long-sleeved shirt and long pants
~ Shoes plus socks
~ Chemical resistant gloves (except for applicators)"
See Engineering Controls for additional requirements.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements* for
the granular product
(not in a SmartBox™
system)
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant insert correct
materials). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart.
Loaders, applicators and other handlers must wear:
~ Long-sleeved shirt and long pants
~ Shoes plus socks
~ Chemical resistant gloves (except for applicators)
~ Loaders must also wear a respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-
14G), or a NIOSH approved respirator with an (OV) cartridge, or
- a canister with any *N,R,P or HE prefilter"
See Engineering Controls for additional requirements.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
20
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Table XI: Summary of Labeling Changes for Chlorethoxyfos
Description
Required Labeling
Placement on Label
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other
laundry."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(immediately following the
PPE requirements)
Engineering Controls
"IMPORTANT: the SmartBox™ system when used correctly qualifies as a closed loading system
under the WPS.
Loaders using the SmartBox™ system must:
--wear the PPE specified above for loaders
~ in addition to wearing the required PPE, have immediately available for use in case of an
emergency: chemical-resistant apron, chemical-resistant footwear, and a NIOSH-approved
respirator with 1) an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or 2) a canister approved for pesticides
(MSHA/NIOSH approval prefix TC-14G), or 3) an organic vapor (OV) cartridge or canister with
any N*, R, P, or HE prefilter.
Applicators must be in enclosed cabs and must:
--wear the PPE specified above for applicators,
-in addition to wearing the required PPE, have available for use: coveralls, chemical-resistant
gloves, and protective eyewear if it is necessary to exit the cab and contact pesticide-treated
surfaces in the treated area,
--remove PPE that was worn in the treated area before reentering the cab, and
--store all PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination
of the inside of the cab. "
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(immediately following
PPE and User Safety
Requirements.)
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly
and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of the
gloves before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
Restricted-Entry
Interval
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of
48 hours. The REI is 72 hours where average rainfall is less than 25 inches per year."
21
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Table XI: Summary of Labeling Changes for Chlorethoxyfos
Description
Early Entry Personal
Protective Equipment
Double Notification
Statement
General Application
Restrictions
Required Labeling
"PPE required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, such as plants, soil, or
water, is:
~ coveralls
~ chemical resistant gloves
~ shoes plus socks"
"Double Notification: Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated areas."
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
Placement on Label
Directions for Use,
Agricultural Use
Requirements Box
Directions for Use,
Agricultural Use
Requirements Box
Directions for Use directly
above the Agricultural Use
Box.
* PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective
PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.
Instructions in the Labeling Required section not in quotes represent actions that the registrant must take to amend their labels or product registrations.
22
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2. Procedure and Timing for Label Amendment
Registrants must submit applications for amended registration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of each revised label,
and a description on the application, such as, "Responding to Interim Tolerance Reassessment
Evaluation and Risk Management Document." Registrants should send applications for amendment
to the appropriate following address within 90 days after receipt of this document.
Document Processing Desk (APPL)
Office of Pesticide Programs
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
Attn: Dr. William Sproat
Insecticide Branch (7505C)
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Report on FQPA Tolerance Reassessment and Interim Risk
Management Decision. Persons other than the registrant may generally distribute or sell such
products for 24 months from the date of the issuance of this Report on FQPA Tolerance
Reassessment Progress and risk management decision. 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.
VI. Related Documents and How to Access Them
This report is supported by documents that are presently maintained in the OPP docket. The
OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
It is open Monday through Friday, excluding legal holidays from 8:30 AM to 4:00 PM.
The docket initially contained the preliminary risk assessment and related documents as of
January 15, 1999. On March 15, the first public comment period closed. EPA then considered
comments, revised the risk assessment, and placed the revised risk assessment in the docket on
August 18, 1999. All documents, in hard copy form, may be viewed in the OPP docket room or
viewed or downloaded via the Internet (http://www.epa.gov/pesticides/).
23
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Appendix I. Bibliography
GUIDE TO BIBLIOGRAPHY
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregi strati on Eligibility Document. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in those
instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional bibliographic
citation. The Agency has also attempted to unite basic documents and commentaries upon
them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to
be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for
certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
24
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evidence contained in the document. When the date appears as (19??), the Agency
was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted
to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
25
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BIBLIOGRAPHY
MRID
CITATION
4088371 1 Sarver, J. (1987) Acute Oral Toxicity Study with IN 43898 in Male and Female Rats: Laboratory
Report No. 282-87. Unpublished study prepared by E. I. Du Pont de Nemours and Co., Inc. 26 p.
40883712 Wilborn, W.; Klingensmith, J. (1986) Acute Oral Toxicity of SD 208304 in the Rat: Du Pont Report
No. WRC RIR-459. Unpublished study prepared by Shell Development Co. 42 p.
40883713 Yankavitch, C.; Malley, L.; Stevens, D. (1986) Acute Oral Toxicity of SD208304 Technical in the
Mouse: Laboratory Project ID WTP 356. Unpublished study prepared by Shell Development Co.
61 p.
40883715 Brock, W. (1987) Acute Dermal toxicity Study of IN 43898 in Rabbits: Haskell Laboratory Report
No. 506-87. Unpublished study prepared by E. I. Du Pont de nemours and co., Inc. 25 p.
40883716 Valentine, R. (1987) Acute Inhalation Toxicity Study with IN 43898 in Rats: Laboratory Project ID
679-87. Unpublished study prepared by E. I. Du Pont de Nemours and Co., Inc. 44 p.
40883717 Valentine, R. (1987) Eye Irritation Test in Rabbits of IN 43898: Laboratory Study ID 4581-488.
Unpublished study prepared by Du Pont de Nemours and Co., Inc. 15 p.
40883718 Brock, W. (1988) Primary Dermal Irritation Study with IN 43898 in Rabbits: Laboratory Project ID
607-88. Unpublished study prepared by E. I. Du Pont de Nemours and Co., Inc. lip.
40883720 Sarver, J. (1988) Acute Oral Toxicity Study with IN 43898-16 in Male and Female Rats: Laboratory
Project ID 489-88. Unpublished study prepared by Du Pont de nemours & Co., Inc. 25 p.
40883721 Brock, W. (1988) Acute Dermal Toxicity Study of IN 43898-16 in Rabbits: Laboratory Project ID
491-88. Unpublished study prepared by Du Pont de Nemours & Co., Inc. 17 p.
40883722 Brock, W. (1987) Approximate Lethal Dose (ALD) by Skin Absorption of IN 43898-4 in Rabbits:
Laboratory Project ID 4581-496. Unpublished study prepared by Du Pont de Nemours & Co. 9 p.
40883723
40883724
Brock, W. (1988) Primary Eye Irritation Study with IN 43898-16 in Rabbits: Laboratory project ID
239-88. Unpublished study prepared by Du Pont de Nemours & Co., Inc. 19 p.
Brock, W. (1988) Primary Dermal Irritation Study with IN 43898-16 in Rabbits: Laboratory Project
ID 324-88. Unpublished study prepared by Du Pont de Nemours & Co., Inc. 12 p.
40883725 Brock, W. (1988) Closed-patchedRepeatedlnsultDermal Sensitization Study (Buehler Method) with
IN 43898-16 in Guinea Pigs: Laboratory Project ID 474-88. Unpublished study prepared by Du Pont
de Nemours and Co., Inc. 22 p.
40883726 Arce, G. (1987) Mutagenicity Testing of Phosphorothioic Acid,
O,ODiethyl-O-(l,2,2,2-Tetrachloroethyl) Ester in the Salmonella typhimurium Plate Incorporation
Assay: HLR 257-87. Unpublished study prepared by E. I. Du Pont de Nemours and Co., Inc. 20 p.
26
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BIBLIOGRAPHY
MRID
CITATION
40883727 Bentley, K. (1988) Mutagenicity Evaluation of Fortress Technical in the CHO/HPRT Assay: HLR
Report No. 316-88. Unpublished study prepared by E. I. Du Pont de Nemours and Co., Inc. 20 p.
40883728 Jannasch, M; Sawin, V. (1986) Genetic Toxicity Assay of SD 208304: Gene Mutation Assay in
Mammalian Cells in Cultures L5178Y, Mouse Lymphoma Cells: Laboratory Project ID WTP 355.
Unpublished study prepared by Westhollow Research Center. 31 p.
40883729 Vlachos, D. (1988) Mouse Bone Marrow Micronucleus Assay of Fortress Technical (IN 43898):
Haskell Report No. 340-88. Unpublished study prepared by E. I. Du Pont De Nemours and Co., Inc.
19 p.
40883730 Bentley, K. (1988) Assessment of Fortress Technical in the in vitro Unscheduled DNA Synthesis
Assay in Rat Primary Hepatocytes: Laboratory Project ID 259-88. Unpublished study prepared by
E. I. Du Pont de Nemours and Co., Inc. 19 p.
40883731 Vlachos, D. (1988) In vitro Evaluation of Fortress Technical (IN 43898) for Chromosome
Aberrations in Human Lymphocytes: Haskell Laboratory Report No. 234-88. Unpublished study
prepared by E. I. du Pont de Nemours and Co., Inc. 24 p.
40898702 Maedgen, J. (1986) Acute Delayed Neurotoxicity Study in Hens with SD-208304: Project ID:
3545-84. Unpublished study prepared by Stillmeadow, Inc. 79 p.
40898703 Malley, L. (1988) Subchronic Oral Toxicity: 90-Day Study with IN 43898 Feeding Study in Dogs:
Project ID; Haskell Laboratory Report No. 189-88. Unpublished study prepared by E.I. du Pont de
Nemours & Co., Inc. 353 p.
40898704 Dickie, B. (1986) Five-Week Dietary Feeding Study in Dogs of SD 208304 (Technical): HLA Study
No. 6160-108; Shell Protocol No. WTP 362; HLA Protocol TP 6154. Unpublished study prepared
by Hazleton Laboratories America, Inc. 293 p.
40898705 Alvarez, L. (1988) Teratogenicity Study of IN 43898 (Fortress Technical) in Rats: Project ID:
306-88; Medical Research No. 8145-001. Unpublished study prepared by E.I. du Pont de Nemours
and Co., Inc. 191 p.
41290602 Ryan, D.; Fukuto, J. (1989) Metabolism of (Carbon 14)-DPX-43898 inLactating Goats: Lab Project
Number: ABC/36456: ABC/36467. Unpublished study prepared by ABC Laboratories, Inc. 176 p.
41290604 Slates, R. (1989) Residue Method for Determination of DPX-43 898, the Active Ingredient of Fortress
Insecticide and its Oxon Analog IN-34158 in Corn Grain, Green Forage and Stover by Gas
Chromatography with Mass Spectrometric Detection: Lab Project Number: AMR/1195/88.
Unpublished study prepared by du Pont de Nemours and Co. 35 p.
27
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BIBLIOGRAPHY
MRID
CITATION
41290608 Barber, G. (1989) AnalyticalMethodfortheDeterminationofResiduesofDPX-43898andIN-34158
in Corn and Processed Products: Lab Project Number: AMR/1507/89. Unpublished study prepared
by du Pont de Nemours and Co. 27 p.
41290610 Slates, R. (1989) Freezer Storage Stability of Fortress Insecticide Active Ingredient DPX-43898 in
Corn Grain, Green Forage , and Mature Fodder: Lab Project Number: AMR/1323/88. Unpublished
study prepared by du Pont de Nemours and Co. 22 p.
41290611 Slates, R. (1989) Freezer Storage Stability of Fortress Oxon Analogue IN-34158 in Corn Grain,
Green Forage, and Mature Fodder: Lab Project Number: AMR/1324/88. Unpublished study
prepared by du Pont de Nemours and Co. 22 p.
41290614 Slates, R.; Woodward, M.; Crowe, C. (1989) Magnitude of Residues of Fortress Insecticide when
Applied to Corn: Lab Project Number: AMR/1059/88. Unpublished study prepared by du Pont de
Nemours and Co. 73 p.
41290615 Slates, R.; Crowe, C.; Bollin, E. (1989) Magnitude of Fortress Insecticide Residues in Corn Over
Time: Lab Project Number: AMR/1144/88. Unpublished study prepared by du Pont de Nemours
and Co. 59 p.
41290616 Barber, G. (1989) Magnitude of Residues of DPX-43898, its Oxon Analog and Trichloroacetic Acid
in Corn Grain and Some Products Derived from Dry Milling: Lab Project Number: AMR/941/87.
Unpublished study prepared by du Pont de Nemours and Co. 3 8 p.
41290620 Fukuto, I; Pukalski, C. (1989) A Confined Rotational Crop Study Using [Carbon 14]-DPX-43898:
Lab Project Number: AMR/1180/88. Unpub. study prepared by du Pont de Nemours and Co. 65 p.
41290623 Brock, W. (1988) Acute Dermal Toxicity Study of DPX-43898-26 inRabbits: Lab Project Number:
4581/661 : 730/88. Unpublished study prepared by du Pont de Nemours and Co. 12 p.
41290624 Brock, W. (1988) Primary Irritation Study with DPX-43898-26 in Rabbits: Lab Project Number:
732/88 : 4581/661. Unpublished study prepared by du Pont de Nemours and Co. 19 p.
41290626 Brock, W. (1989) Closed-Patch Repeated InsultDermal Sensitization Study (Buehler Method) with
DPX-43898-26 in Guinea Pigs: Lab Project Number: 4581/89. Unpublished study prepared by du
Pont de Nemours and Co. 30 p.
41290627 Malley, L. (1988) Subchronic Oral Toxicity: 90-Day Study with IN-43898: 90-Day Feeding and
One-generation Reproduction Study in Rats: Lab Project Number: 407/87. Unpublished study
prepared by du Pont de Nemours and Co. 494 p.
41290628 Sarver, J. (1988) Ten-Dose Oral Subchronic Study of IN-43898 inFemale Rats: Lab Project Number:
4581/431. Unpublished study prepared by du Pont de Nemours and Co. 39 p.
28
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BIBLIOGRAPHY
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41290629 Malley, L. (1988) Subchronic Oral Toxicity: 90-Day Study with IN 43898: Feeding Study in Mice:
Lab Project Number: 3 97/87 : 8023/001. Unpublished study prepared by du Pont de Nemours and
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41290630 Malley, L. (1989) Subchronic Oral Toxicity: Six-week Study with IN 43898: Feeding Stu dy inMice:
Lab Project Number: 8242/001 : 142/88. Unpublished study prepared by du Pont de Nemours and
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41290631 Sarver, J. (1988) Ten-Dose Oral Subchronic Study of IN 43898 in Mice: Lab Project Number:
4581/431 : 552/87. Unpublished study prepared by du Pont de Nemours and Co. 39 p.
41290632 Malley, L. (1989) Determination of the Cholinesterase Activity in Rats and Mice Fed IN 43898 for
Six Weeks: Lab Project Number: HLR/407/87 :HLR/397/87 : 40/89. Unpublished study prepared
by du Pont de Nemours and Co. 184 p.
41290633 Alvarez, L. (1989) Teratogenicity Study of IN 43898 (Fortress Technical) inRabbits: Lab Project
Number: 697/88: 8156/001. Unpublished study prepared by du Pont de Nemours and Co. 135 p.
41290634 Malley,L. (1989) Combined Chronic Toxicity/Oncogenicity Study withIN43898: Two-year Feeding
Study in Rats: One-year Interim Report: Lab Project Number: 8233/001 : 690/88. Unpublished
study prepared by du Pont de Nemours and Co. 731 p.
41290635 Woodward, M. (1989) Metabolism of Radiolabeled DPX-43898 in Male and Female Rats: Lab
Project Number: AMR/853/87: MR/8198. Unpublished study prepared by du Pont de Nemours and
Co. 139 p.
41290639 Gerling, J. (1989) Simulated Granule Exposure Study of Fortress 5G: Lab Project Number:
AMR/1545/89. Unpublished study prepared by du Pont de Nemours and Co. 14 p.
41736804 Woodward,M. (1990) Metabolism of [Carbon 14]-DPX-43898 in Lactating Goats: Supplement: Lab
Project Number: AMR-962-87. Unpublished study prepared by E. I. Du Pont de Nemours and Co.,
Inc. 9 p.
41736806 Freerksen, D. (1990) Potential for Residues of DPX-43898 in Livestock Meat, Meat By-products, and
Milk: Lab Project Number: AMR1647-90. Unpublished study prepared by E. I. Du Pont de Nemours
and Co., Inc. 30 p.
41736807 Barber, G. (1989) Analytical Method for the Determination of Residues of DPX-43898 in Corn: Lab
Project Number: AMR-1546-89. Unpublished study prepared by E. I. Du Pont de Nemours and Co.,
Inc. 20 p.
41736808 Barber, G. (1989) Analytical Method for the Determination of Residues of DPX-43898 in Corn:
Supplement: Lab Project Number: AMR1546-89. Unpublished study prepared by E. I. Du Pont de
Nemours and Co., Inc. 10 p.
29
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41736809 Barber, G. (1990) Method Validation Study for DPX-43898 in Corn: Lab Project Number:
AMR-1625-90. Unpublished study prepared by McKenzie Laboratories. 53 p.
41736810 Barber, G. (1990) Method Validation Study for DPX-43898 in Corn Dry Fodder (Stover): Lab
Project Number: AMR-1732-90. Unpublished study prepared by Minnesota Valley Testing
Laboratories, Inc. 54 p.
41736813 Gilles, C.; Labare, A.; Fomenko, J. (1990) Testing of Trichloroacetic Acid through FDA
Multi-residue Protocols A-E: Lab Project Number: AMR-1483-89: 89008. Unpublished study
prepared by Biospherics, Inc. 93 p.
41736814 Labare, A.; Fomenko, J. (1990) Testing of DPX-43898 through FDA Multi-residue Protocols A-E:
Lab Project Number: AMR-1404-89: 89002. Unpub. study prepared by Biospherics, Inc. 147 p.
41736815 Slates, R.; Crowe, C. (1990) Magnitude of Residues of Fortress Insecticide when Applied to Corn:
Lab Project Number: AMR-105988. Unpublished study prepared by E. I. Du pont de Nemours and
Co., Inc. 137 p.
41736816 Slates, R.; Crowe, C. (1990) Magnitude of Residues of Fortress Insecticide when Applied to Corn
Over Time: Lab Project Number: AMR-1144-88. Unpublished study prepared by E. I. Du pont de
Nemours and Co., Inc. 57 p.
41736817 Slates, R.; Crowe, C. (1990) Magnitude of Fortress Insecticide Residues in Sweet Corn Over Time:
Lab Project Number: AMR-1385-89. Unpublished study prepared by E. I. Du pont de Nemours and
Co., Inc. 62 p.
41736818 Slates, R.; Crowe, C. (1990) Magnitude of Fortress Soil Insecticide Residues in Sweet Corn: Lab
Project Number: AMR-1384-89. Unpublished study prepared by E. I. Du pont de Nemours and Co.,
Inc. 94 p.
41736819 Barber, G. (1990) Magnitude of Residues of DPX-43898, its Oxon Analog and Trichloroacetic Acid
in Corn Grain and Some Products Derived from Wet Milling: Lab Project Number: AMR-941-87.
Unpublished study prepared by E. I. Du pont de Nemours and Co., Inc. 47 p.
41736830 Woodward, M. (1990) A Confined Rotational Crop Study Using [Carbon 14]-DPX-43898:
Supplement: Lab Project Number: AMR-1180-88. Unpublished study prepared by E. I. Du Pont de
Nemours and Co., Inc. 102 p.
41736831 Woodward, M.; Crowe, C.;Bolton,E. (1990) Rotational Crops Study with Fortress Soil Insecticide:
Lab Project Number: AMR-1153-88. Unpublished study prepared by E. I. Du Pont de Nemours and
Co., Inc. 66 p.
41736832 Stadler, J. (1990) Acute Inhalation Toxicity Study with IN 43898-54 in Rats: Lab Project Number:
4581-775: 135-90. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 77 p.
30
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41736833 Malley, L. (1989) Chronic Toxicity Study with IN 43898: One Year Feeding Study in Dogs: Lab
Project Number: 216-89: 8314-001. Unpublished study prepared by E. I. du Pont de Nemours and
Co., Inc. 766 p.
41736834 Malley, L. (1990) Oncogenicity Study with IN 43898: Eighteen-month Feeding Study inMice: Lab
Project Number: 8291-001: 16-90. Unpublished study prepared by E. I. du Pont de Nemours and
Co., Inc. 1925 p.
41736835 Sykes, G. (1990) Oncogenicity Study with IN 43898: Eighteen-month Feeding Study in Mice:
Supplement: Lab Project Number: 16-90: 8291-001. Unpublished study prepared by E. I. du Pont
de Nemours and Co., Inc. 46 p.
41736836 Malley, L. (1990) Reproductive and Fertility Effects with IN 43898: Multigeneration Reproduction
Study in Rats: Lab Project Number: 8478-001: 693-89. Unpublished study prepared by E. I. du Pont
de Nemours and Co., Inc. 1401 p.
41736837 Malley, L. (1990) Combined Chronic Toxicity/Oncogenicity study with IN 43898: Two-year Feeding
Study in Rats: Lab Project Number: 649-89: 8233-001. Unpublished study prepared by E. I. duPont
de Nemours and Co., Inc. 1961 p.
41736843 Gerling, J. (1989) Granule Exposure Study for Fortress 5G in Seven Midwest Locations: Lab Project
Number: AMR-1521-89. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc.
26 p.
42559207 Sarver, J. (1992) Acute Dermal Toxicity Study withDPX-43898-26 inRabbits: Lab Project Number:
4581-955: 236-92. Unpublished study prepared by DuPont. 16 p.
42559208 Sarver, J. (1992) Primary Dermal Irritation Study withDPX-43898-26 inRabbits: Lab Proj. Number:
4581-955: 1-92. Unpublished study prepared by DuPont. 22 p.
42559209 Brock, W. (1992) Closed-Patch Repeated InsultDermal Sensitization Study (Buehler Method) with
DPX-43898-26 in Guinea Pigs: Supplement No. 1: Lab Project Number: 4581-661: 142-89.
Unpublished study prepared by DuPont. 12 p.
42559210 Lochry, E. (1992) Acute Neurotoxicity Study of DPX-43898 in Rats: Revision No. 1: Lab Project
Number: 9295-001: 193-92. Unpublished study prepared by DuPont. 526 p.
42559211 Elliott, G.; MacKenzie, S. (1992) Enzyme Inhibition and Recovery Study withDPX-43898 inRats:
Lab Project Number: 9421-001: 699-92. Unpublished study prepared by DuPont. 118 p.
42559212 Malley, L. (1992) Determination of Cholinesterase Activity in Rats and Mice Fed IN 43898 for Six
Weeks: SupplementNo. 1: Lab Project Number: 8598-001:HLR 407-87 :HLR 3 97-87. Unpublished
study prepared by DuPont. 58 p.
31
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42559213 Malley,L. (1992) Subchronic Oral Toxicity: Six-week Study with IN 43 898 Feeding Study in Mice:
SupplementNo. 1: Lab Project Number: 8242-001: 142-88. Unpublished study prepared by DuPont.
58 p.
42559214 Malley, L. (1992) Subchronic Oral Toxicity: 90-day Study with IN 43898 90-day Feeding and
One-generation Reproduction Study in Rats: Supplement No. 1: Lab Project Number: 8022-001:
407-87. Unpublished study prepared by DuPont. 63 p.
42559215 Malley, L. (1992) Subchronic Oral Toxicity: 90-day Feeding Study in Rats with IN 43898
Determination of Effects on Plasma, Red Cells, and Brain Cholinesterase Activity: Lab Project
Number: 9335-001: 540-92. Unpublished study prepared by DuPont. 338 p.
42559216 Malley, L. (1992) Subchronic Oral Toxicity: 90-day Study with IN 43898 Feeding Study in Mice:
SupplementNo. 1: Lab Project Number: 8023-001: 397-87. Unpublished study prepared by DuPont.
61 p.
42559217 Lochry, E. (1992) Subchronic Neurotoxicity: 90-day Study of DPX-43898 Feeding Study in Rats:
Revision No. 1: Lab Project Number: 9304-001: 194-92. Unpublished study prepared by DuPont.
619 p.
42559218 Malley, L. (1992) Combined Chronic Toxicity/Oncogenicity Study withIN 43898 Two-year Feeding
Study in Rats: One-year Interim: Supplement No. 1: Lab Project Number: 8233-001: 690-88.
Unpublished study prepared by DuPont. 58 p.
42559219 Alvarez, L. (1992) Teratogenicity Study of IN 43898 inRabbits: Fortress Technical: SupplementNo.
1: Lab Project Nos.: 8156-001: 697-88. Unpublished study prepared by DuPont. 15 p.
42559220 Woodward, M. (1992) Metabolism of Radiolabeled DPX-43898 in Male and Female Rats:
Supplement No. 1: Lab Project Number: AMR 853-87. Unpub. study prepared by DuPont. 65 p.
42559221 Atkinson, I; Auletta, C. (1992) Subchronic Oral Toxicity: Six-month Ocular Study withDPX-43898
(Fortress Technical) Feeding Study in Dogs: Final Report: Lab Project Number: 91-3718: HLO
432-92. Unpublished study prepared by DuPont. 531 p.
42559222 Jensen, M.; Merricks, D. (1992) Chlorethoxyfos Worker Exposure Study during Application of
Fortress 5G Granular Insecticide to Corn: Lab Project Number: 1715: 2235-91. Unpublished study
prepared by Agrisearch Incorporated. 101 p.
42559223
42559228
Wopschall, R. (1992) Dust Produced during Shipment of Fortress 5G Insecticide: Lab Project
Number: AMR 2443-92. Unpublished study prepared by DuPont. 32 p.
Dulka, J. (1992) Granule Exposure Study for Fortress 5G in Seven Midwest Locations: Supplement
No. 1: Lab Project Number: AMR 1521-89. Unpublished study prepared by DuPont. 9 p.
32
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BIBLIOGRAPHY
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42559235 Slates, R. (1991) Freezer Storage Stability of Fortress Insecticide Active Ingredient DPX-43898 in
Corn Grain, Green Forage, and Mature Fodder: Supplement No. 1: Lab Project Number:
AMR-1323-88. Unpublished study prepared by DuPont. 14 p.
42559238 Slates, R.; Babicki, W. (1991) Freezer Storage Stability of Fortress Insecticide Active Ingredient
DPX-43898 and its Oxon Analogue IN-34158 in Soil: Supplement No. 1: Lab Project Number:
AMR-1244-88. Unpublished study prepared by DuPont. 12 p.
42966101 Elliot, G.; MacKenzie, S. (1992) Enzyme Inhibition and Recovery Study with DPX-43898 in Rats:
Supplemental No. 1: Lab Project Number: 9421-001: 699-92. Unpublished study prepared by
Haskell Laboratory for Toxicology and Industrial Medicine. 70 p.
43540203 Sarver, J. (1994) Acute Oral Toxicity Study With DPX-43898-149 (Fortress 2.5 G) in Male and
Female Rats: Lab Project Numbers: 9906-001: 449-94: HLR 449-94. Unpublished study prepared
by Haskell Lab. for Toxicology and Industrial Medicine (DuPont). 45 p.
43550302 Coody, P. (1992) Field Measurement of DPX-43898 (Fortress Insecticide) Runoff from a Corn
Seedbed in Central Iowa under Simulated Rainfall: (Amended Final Report) Re-Issue: Lab Project
Number: 509:1380: AMR-1898-90. Unpublished study prepared by PTRL East, Inc. and Minnesota
Valley Testing Labs, Inc. 117 p.
43550303 Coody, P. (1993) Field Measurement of DPX-43898 (Fortress Insecticide) Runoff from a Corn
Seedbed in Western Iowa under Simulated Rainfall: (Final Report): Lab Project Number: 513: 1500:
AMR-1899-90. Unpublished study prepared by PTRL East, Inc. and Minnesota Valley Testing Labs,
Inc. 144 p.
43550306 Powley, C. (1994) Chlorethoxyfos Worker Exposure Study During Application of Fortress 5G
Granular Insecticide to Corn: Supplement No. 1: Lab Project Number: AMR 2235-91: 1715.
Unpublished study prepared by Agrisearch Inc. and DuPont Agricultural Products. 34 p.
43565901 Layton, R. (1994) Chlorethoxyfos: Prediction of Potential Concentrations in Surface Water
Following Corn Planting in the Mid-Western United States: Lab Project Number: AMR 3138-94.
Unpublished study prepared by DuPont Agricultural Products. 25 p.
44234601 Mikles, K. (1997) Acute Oral Neurotoxicity Study of DPX-43898-171 Fortress in Rats: Lab Project
Number: HLR 627-96: 10694-001: 627-96. Unpublished study prepared by DuPont Haskell Lab for
Toxicology and Industrial Medicine. 343 p.
44261201 Stadler, J. (1997) Inhalation Rangefinding Study with Fortress Technical in Female Rats: Lab Project
Number: HL-1997-00228: 11114-001. Unpublished study prepared by DuPont Haskell Lab for
Toxicology and Industrial Medicine. 73 p.
33
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44301301 Merricks, D.; McNeal, H. (1997) Chlorethoxyfos Applicator Exposure Study during Application of
Fortress 5G Granular Insecticide Using the SmartBox System during Corn Planting in the Midwest:
(Final Report): Lab Project Number: 1750: AMR 3782-96. Unpublished study prepared by
Agrisearch, Inc. 97 p. Relates to letter L0000219.
44382101 Stadler, J. (1997) Fortress Technical: Repeated Dose Inhalation Toxicity Study inFemaleRats: Lab
Project Number: 11114-001: HL-1997-00229. Unpublished study prepared by E.I. du Pont de
Nemours and Co. (Haskell Lab.) 143 p.
44399802 Mullin, L. (1997) Worker Exposure Risk Assessment for Fortress 5G in the SmartBox Closed
Handling and Application System: Lab Project Number: CHLORE/GEN 3. Unpublished study
prepared by DuPont Agricultural Products. 15 p.
44414001 Foster, J.; Grimes, J.; Beavers, J. (1997) DPX-43898 (Chlorethoxyfos): A Delayed Neurotoxicity
Study in Laying Hens: (Final Report): Lab Project Number: 112-436: 4006-96. Unpublished study
prepared by Wildlife International Ltd. 199 p.
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Appendix II: Pesticide Registration Kit www.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
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
II Biopesticides and Pollution Prevention Division (BPPD) Contacts
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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' Web Site
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. Please note that EPA is currently
in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office
of Pesticide Programs. We anticipate that this publication will become available during
the Fall of 1998.
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 Web site.
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 Web site:
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
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applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for
the new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common
and trade names, company experimental codes, and other names which identify the
chemical (including "blind" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a CAS number if one has been
assigned.
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