United States Prevention, Pesticides EPA 738-R-00-003

Environmental Protection And Toxic Substances June 2000

Agency (7508C)

Report on FQPA Tolerance

Reassessment Progress 

and Interim Risk 

Management Decision for

Chlorethoxyfos
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 reregistration

process. Each pesticide registered prior to 1984 is subject to a comprehensive evaluation of its

effects on human health and the environment. Such an evaluation includes a determination of

whether the tolerances are safe. Since chlorethoxyfos was registered after 1984, it is not subject

to reregistration. 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
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 reregistration and/or tolerance

reassessment decisions for these pesticides. As part of the Agency’s effort to involve the public in

the implementation of the FQPA, the Agency is undertaking a special effort to maintain open

public dockets on the organophosphate pesticides and to engage the public in the reregistration

and tolerance reassessment processes for these chemicals. This open process follows the

guidance developed by the Tolerance Reassessment Advisory Committee (TRAC), a large multistakeholder advisory body which advised the Agency on implementing the new provisions of the

FQPA. The reregistration and tolerance reassessment reviews for the organophosphate pesticides

are following this new process. 

Please note that the 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.
If you have questions on this document or the proposed label changes, please contact the

Special Review and Reregistration Division representative, Deanna Scher at (703) 308-7043.

Sincerely yours,

Lois A. Rossi, Director

Special Review and 

 Reregistration Division

Enclosures
Report on FQPA Tolerance Reassessment Progress 

and Interim Risk Management Decision

for

Chlorethoxyfos
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 Disruptor 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
C. Existing Stocks ................................................ 23

VI. Related Documents and How to Access Them ............................. 23

Appendix I. Bibliography .................................................. 24

Appendix II: Pesticide Registration Kit ....................................... 35
i

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
ii

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

DRES 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.

HDT 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/l, 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

LOC 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.

μg/g Micrograms Per Gram

Fg/L Micrograms per liter

mg/L Milligrams Per Liter

MOE Margin of Exposure 
iii

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

*

1 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
iv

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 lb 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 postapplication 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:
v

• Labels must state that in addition to the PPE which loaders of the Fortress® 5G in the

SmartBoxTM 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.
1

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 reregistration and/or FQPA tolerance

reassessment initiatives on pesticides. Since chlorethoxyfos was first registered in 1995, it is currently

not subject 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
2

the Agency on implementing the new provisions of the FQPA. The reregistration 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 Reregistration 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 USDA, 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:

C Applying the FQPA 10-Fold Safety Factor

C Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments 

C How to Interpret "No Detectable Residues" in Dietary Exposure Assessments

C Refining Dietary (Food) Exposure Estimates

C Refining Dietary (Drinking Water) Exposure Estimates

C Assessing Residential Exposure

C Aggregating Exposure from all Non-Occupational Sources

C How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides

with a Common Mechanism of Toxicity

C Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates

C 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. 
3

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

reregistration 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

( 2

 P-O-CH-CCl3

' *

CH3-CH2-O Cl

• Common Name: Chlorethoxyfos

• Chemical Name: O,O-Diethyl O- (1,2,2,2-tetrachloroethyl)

phosphorothioate
4

• Chemical Family: Organophosphate

• CAS Registry Number: 54593-83-8

• OPP Chemical Code: 129006 

• Empirical Formula: C6H11Cl4O3PS

• 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 SmartBoxTM , which is a completely

enclosed, tamper-proof delivery system. The 2.5% formulation is
5

supplied in 50 lb. 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 lb

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.
6

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 Toxicity Category (Technical) 5% a.i. end-use product (Fortress® 5G)*

Acute Oral I I**

Acute Dermal I III

Acute Inhalation I II

Primary Eye Irritation I III

Primary Skin Irritation I IV

Dermal Sensitization NA (non-sensitizing) 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.
7

Table II: Summary of Toxicological Endpoints for Human Dietary Risk Assessment of Chlorethoxyfos

Assessment Dose Endpoint Study UF FQPA

Safety

Factor

aPAD/cPAD*

Acute

Dietary

NOAEL =

0.06

mg/kg/day

Plasma cholinesterase

inhibition 

Based on day 3 of a 6-

month oral study in

dogs

100 1X 0.0006

mg/kg/day

Chronic

Dietary

NOAEL =

0.06

mg/kg/day

Overall (plasma, red

blood cell and/or brain)

cholinesterase

inhibition following

subchronic and chronic

exposures

 Based on the

combined results of the

90-day, 6-month and 1-

year feeding studies in

dogs 

100 1X 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., 10x for inter

species extrapolation, 10x 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 1X 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. 
1

 For a complete listing of chlorethoxyfos tolerances, see Section IV of this document.

8

3. Dietary Exposure Assumptions

Revised dietary risk analyses for chlorethoxyfos were conducted using the Dietary Exposure

Evaluation Model (DEEMTM). DEEMTM 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 1⁄2 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 10x 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 subpopulation 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 Acute Tier 3 Probabilistic

Assessment*

Chronic Tier 2 Assessment

U.S. Population 0.5% < 0.1%

Non-nursing Infants

(less than 1 year old)

0.2% 0.1%

Children, 1-6 years old 2.0% 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
9

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 PRZMEXAMS, a Tier 2 model. This model, although considered screening level, is based on more refined

assumptions than the Tier I GENEEC 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 Acute (High) Concentration (ppb) Chronic (60-day) Concentration (ppb)

In-Furrow 0.064 0.012

T-Band 0.427 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.
10

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 Exposure

Route

Dose Endpoint Study

Short Term (1-7 days) Dermal Dermal NOAEL = 1.25

mg/kg/day

RBC

cholinesterase

inhibition (ChEI)

21-day dermal

toxicity study in rats

Intermediate Term 

(7 days - several months)

Dermal Dermal NOAEL = 1.25

mg/kg/day

RBC ChEI 21-day dermal

toxicity study in rats

Short Term (1-7 day) Inhalation Inhalation NOAEL =

0.00058 mg/L (0.13

mg/kg/day)

Plasma, RBC,

and brain ChEI

7-day inhalation

study in rats*

Intermediate Term 

(7 days - several months)

Inhalation Oral NOAEL = 0.06

mg/kg/day

Plasma ChEI 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. 
11

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 lb 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

SmartBoxTM 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 Loaders Applicators

Fortress® 5G in

the

SmartBoxTM

Long-sleeved shirt and long pants,

shoes plus socks, chemical resistant gloves, protective

eyewear.

Closed cab. Long-sleeved shirt

and long pants, shoes plus socks.*

Fortress® 2.5G

in 50 lb. bags

Coveralls, long-sleeved shirt and long pants, shoes plus

socks, chemical resistant gloves, protective eyewear, an

organic vapor equipped with either an organic vaporremoving cartridge or canister.

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.
12

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 SmartBoxTM

Scenario/Rate Dermal Inhalation Combined MOE

Application

Scenario

(lb

ai/day)

UEb

mg/lb a.i.

ADDc

(mg/kg/day) 

Short-& interm.-

term MOEd

UEe

mg/day

ADDf

(mg/kg/day) 

Short-term

MOEd

Interm.-term

MOEd

MOE Totalg

Loader a

- using a

SmartBoxTM 

29.25 0.0002 0.000084 15,000 9.6X10-5 1.4 X10-6 93,000 43,000 Short-term 13,000

Interm.-term 11,000

Applicator -closedcab tractor29.25 0.00081 0.00034 3,700 0.0019 2.7 X10-5 4800 2200 Short-term 2100

Interm-term 1400

Combinedh29.25 0.0010 0.00042 3,000 0.0020 2.8 X10-5 4600 2100 Short-term 1800

Interm.-term 1200

a

 Loader exposure reflects closed system (SmartBoxTM), 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

c

 ADD(mg/kg/day) [dermal]: = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 lb 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 NOAEL= 0.13 mg/kg/day =0.000508 mg/l X (10.3 l/hr sprague-Dawley inhalation rate) X ( rat exposed 6hrs/day) divided by 0.236

kg (Sprague-Dawley rat body weight).

e 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 435liters/day = 9.6X10-5 mg/day; UE

(applicator) =(0.14 nanograms ai/liter) X (1 X10-6 mg/nanogram) X 13,485 liters/day= 0.0019 mg/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)..

g

 MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs: 1 / (1/MOEdermal +

1/MOEinhalation ); these MOEs have a common endpoint. 

1 = Short-term, and 2 = 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 lb. product/acre (equivalent to 0.1625 lb a.i./acre)

Table VIII. Occupational Handler Exposure Estimates and Risk Assessment Summary:

Fortress 2.5G Granules with Single Layer Body Protection

Scenario/Rate Dermal

(With baseline PPE plus gloves)a

Inhalation 

 (With OV respirator for loader)

Combined MOE

Application

Scenario (lb ai/day)

UEb

(mg/lb a.i.)

ADDc

 (mg/kg/day) 

MOEd UEe

 (mg/day)

ADDf

 (mg/kg/day) 

Short-term

MOEd

Interm.-term

MOE

MOE Totalg

Loadera (without

coveralls)

29.25 0.0023 0.00096 1300 0.001 1.4 E-05 9300 4300 Short-term 1100

Interm.-term 1000

Applicator in a

closed-cab tractor

29.25 0.0025 0.00 10 1200 0.0047 6.7 E-05 1900 900 Short-term 740

Interm.-term 510

Combined 29.25 0.0048 0.0020 620 0.0057 8.1 E-05 1600 740 Short-term 450

Interm.-term 340

a

 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.

b

 UE = Unit Exposure is the amount of exposure measured in terms of mg a.i./lb a.i handled

cADD(mg/kg/day): = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 lb a.i./day / 70 kg wt;

dMOE = NOAEL/ADD

e UE = 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].

g MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs:

1 / (1/MOEdermal + 1/MOEinhalation ); these MOE have a common endpoint

The study data this is based on used 5.5 lb of product with 5% ai, equal to 0.275 lb ai/acre ; data were adjusted to current label application rate of 6.5

lb. product/acre (equivalent to 0.1625 lb a.i./acre).
13

Table IX. Occupational Handler Exposure Estimates and Risk Assessment Summary: Fortress

2.5G Granules with Double Layer Body Protection

Scenario/Rate Dermal

(With Coveralls)a

Inhalation 

(With OV respirator for loader)

Combined MOE

Application

Scenario lb ai/day

UEb

(mg/lb a.i.)

ADDc

(mg/kg/day) 

MOEd UEe

 (mg/day)

ADDf

(mg/kg/day) 

Short-term

MOEd

Interm.-term

MOE

MOE Totalg

Loadera (with

coveralls)

29.25 0.0016 0.00066 1900 0.001 1.4 E-05 9300 4300 Short-term 1600

Interm.-term 1300

Applicator using a

closed-cab tractor

29.25 0.0017 0.00071 1800 0.0047 6.7 E-05 1900 900 Short-term 920

Interm.-term 600

Combined 29.25 0.0033 0.0014 910 0.0057 8.1 E-05 1600 740 Short-term 580

Interm.-term 410

a

 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.

cADD(mg/kg/day): = unit exposure (UE) from studies in mg/lb a.i. handled * 29.25 lb a.i./day / 70 kg wt;

dMOE = NOAEL/ADD

e UE = 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].

g MOE Total is based upon the following formula: the inverse of the sum of the inverses of the dermal and inhalation MOEs: 1 / (1/MOEdermal +

1/MOEinhalation ); these MOEs have a common endpoint.

The study data this is based on used 5.5 lb of product with 5% ai, equal to 0.275 lb ai/acre ; data were adjusted to current label application rate of 6.5

lb. product/acre (equivalent to 0.1625 lb 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. 
14

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 lb product at 5% ai/A=0.275 lb ai/A) to that on the current label (6.5 lb at 2.5%

ai/A = 0.1625 lb 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
15

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. 
16

Table X: Tolerance Summary for Chlorethoxyfos

Commodity Parts per million

Corn, field, forage 0.01

Corn, field, grain 0.01

Corn, field, stover (fodder) 0.01

Corn, pop, grain 0.01

Corn, pop, stover (fodder) 0.01

Corn, sweet (K + CWHR) 0.01

Corn, sweet, forage 0.01

Corn, sweet, stover (fodder) 0.01

2. Endocrine Disruptor 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 Disruptor 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 Disruptor 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

SmartBoxTM 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.
17

• "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 SmartBoxTM 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.
18

The Agency recognizes that no system is fail-safe, therefore, in addition to the PPE that

loaders of the Fortress® 5G in the SmartBoxTM 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 chemicalresistant 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 longsleeved 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. III 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".
19

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. 
20

Table XI: Summary of Labeling Changes for Chlorethoxyfos

Description Required Labeling Placement on Label

End Use Products Intended for Use on Corn

PPE Requirements* for

the granular product in

a SmartBoxTM 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 SmartBoxTM

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 TC14G), 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 
Table XI: Summary of Labeling Changes for Chlorethoxyfos

Description Required Labeling Placement on Label

21

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 SmartBoxTM system when used correctly qualifies as a closed loading system

under the WPS. 

Loaders using the SmartBoxTM 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."
Table XI: Summary of Labeling Changes for Chlorethoxyfos

Description Required Labeling Placement on Label

22

Early Entry Personal

Protective Equipment

“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"

Directions for Use,

Agricultural Use

Requirements Box

Double Notification

Statement

"Double Notification: Notify workers of the application by warning them orally and by posting

warning signs at entrances to treated areas."

Directions for Use,

Agricultural Use

Requirements Box

General Application

Restrictions

"Do not apply this product in a way that will contact workers or other persons, either directly or

through drift. Only protected handlers may be in the area during application."

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.
23

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/).
24

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 Reregistration Eligibility Document. Primary sources for studies in this bibliography have

been the body of data submitted to EPA and its predecessor agencies in support of past

regulatory decisions. Selections from other sources including the published literature, in those

instances where they have been considered, are included.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of

published materials, this corresponds closely to an article. In the case of unpublished

materials submitted to the Agency, the Agency has sought to identify documents at a level

parallel to the published article from within the typically larger volumes in which they were

submitted. The resulting "studies" generally have a distinct title (or at least a single subject),

can stand alone for purposes of review and can be described with a conventional bibliographic

citation. The Agency has also attempted to unite basic documents and commentaries upon

them, treating them as a single study.

3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically

by Master Record Identifier, or "MRID” number. This number is unique to the citation, and

should be used whenever a specific reference is required. It is not related to the six-digit

"Accession Number" which has been used to identify volumes of submitted studies (see

paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the

bibliography late in the review may be preceded by a nine character temporary identifier.

These entries are listed after all MRID entries. This temporary identifying number is also to

be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists

of a citation containing standard elements followed, in the case of material submitted to EPA,

by a description of the earliest known submission. Bibliographic conventions used reflect the

standard of the American National Standards Institute (ANSI), expanded to provide for

certain special needs.

a Author. Whenever the author could confidently be identified, the Agency has chosen

to show a personal author. When no individual was identified, the Agency has shown

an identifiable laboratory or testing facility as the author. When no author or

laboratory could be identified, the Agency has shown the first submitter as the author.

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
25

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.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

26

40883711 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. 11 p.

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 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.

40883724 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-patched Repeated Insult Dermal 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-(1,2,2,2-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.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

27

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 in Lactating 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-43898, 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.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

28

41290608 Barber, G. (1989) Analytical Method for the Determination of Residues of DPX-43898 and IN-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. 38 p.

41290620 Fukuto, J.; 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 in Rabbits: 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 Insult Dermal 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 in Female Rats: Lab Project Number:

4581/431. Unpublished study prepared by du Pont de Nemours and Co. 39 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

29

41290629 Malley, L. (1988) Subchronic Oral Toxicity: 90-Day Study with IN 43898: Feeding Study in Mice:

Lab Project Number: 397/87 : 8023/001. Unpublished study prepared by du Pont de Nemours and

Co. 399 p.

41290630 Malley, L. (1989) Subchronic Oral Toxicity: Six-week Study with IN 43898: Feeding Stu dy in Mice:

Lab Project Number: 8242/001 : 142/88. Unpublished study prepared by du Pont de Nemours and

Co. 121 p.

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) in Rabbits: 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 with IN 43898: 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.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

30

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.
BIBLIOGRAPHY

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____________________________________________________

31

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 in Mice: 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. du Pont

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 with DPX-43898-26 in Rabbits: Lab Project Number:

4581-955: 236-92. Unpublished study prepared by DuPont. 16 p.

42559208 Sarver, J. (1992) Primary Dermal Irritation Study with DPX-43898-26 in Rabbits: Lab Proj. Number:

4581-955: 1-92. Unpublished study prepared by DuPont. 22 p.

42559209 Brock, W. (1992) Closed-Patch Repeated Insult Dermal 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 with DPX-43898 in Rats:

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: Supplement No. 1: Lab Project Number: 8598-001: HLR 407-87: HLR 397-87. Unpublished

study prepared by DuPont. 58 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

32

42559213 Malley, L. (1992) Subchronic Oral Toxicity: Six-week Study with IN 43898 Feeding Study in Mice:

Supplement No. 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:

Supplement No. 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 with IN 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 in Rabbits: Fortress Technical: Supplement No.

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, J.; Auletta, C. (1992) Subchronic Oral Toxicity: Six-month Ocular Study with DPX-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 Wopschall, R. (1992) Dust Produced during Shipment of Fortress 5G Insecticide: Lab Project

Number: AMR 2443-92. Unpublished study prepared by DuPont. 32 p.

42559228 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.
BIBLIOGRAPHY

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____________________________________________________

33

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.
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34

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 in Female Rats: 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.
35

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/opppmsd1/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
36

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
37

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.