United States Prevention, Pesticides EPA 738-R-00-002

Environmental Protection And Toxic Substances June 2000

Agency (7508C)

Interim Reregistration

Eligibility Decision (IRED)

Bensulide
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 (hereafter referred to as EPA or

the Agency) has completed its review of the available data and public comments received related to the

preliminary and revised risk assessments for the organophosphate pesticide bensulide. The public

comment period on the revised risk assessment phase of the reregistration process is closed. Based on

comments received during the public comment period and additional data received from the registrant,

the Agency revised the human health and environmental effects risk assessments and made them

available to the public on June 16, 1999. Additionally, the Agency held a Technical Briefing on June 16,

1999, where the results of the revised human health and environmental effects risk assessments were

presented to the general public. This Technical Briefing concluded Phase 4 of the OP Public

Participation Pilot Process developed by the Tolerance Reassessment Advisory Committee, and initiated

Phase 5 of that process. During Phase 5, all interested parties were invited to participate and provide

comments and suggestions on ways the Agency might mitigate the estimated risks presented in the

revised risk assessments. This public participation and comment period commenced on June 16, 1999,

and closed on August 16, 1999.

Based on its review, EPA has identified risk mitigation measures that the Agency believes are

necessary to address the human health and environmental risks associated with the current use of

bensulide. The EPA is now publishing its interim reregistration eligibility and risk management decision

for the current uses of bensulide and its associated human health and environmental risks. The tolerance

reassessment decision for bensulide will be finalized once the cumulative assessment for all of the

organophosphate pesticides is complete. The Agency’s decision on the individual chemical bensulide

can be found in the attached document entitled, “Interim Reregistration Eligibility Decision for

Bensulide.”

A Notice of Availability for this Interim Reregistration Eligibility Decision for Bensulide is published

in the Federal Register. To obtain a copy of the Interim RED document, please contact the Pesticide

Docket, Public Response and Program Resources Branch, Field Operations Division (7506C), Office of

Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone (703) 305-5805. Electronic

copies of the Interim RED and all supporting documents are available on the Internet. See

http:www.epa.gov/pesticides/op.

The Interim RED is based on the updated technical information found in the bensulide public

docket. The docket not only includes background information and comments on the Agency’s
preliminary risk assessments, it also now includes the Agency’s revised risk assessments for bensulide

(revised as of June 16, 1999 and updated in two February, 2000 addenda), and a document

summarizing the Agency’s Response to Comments. The Response to Comments document addresses

corrections to the preliminary risk assessments submitted by chemical registrants, as well as responds to

comments submitted by the general public and stakeholders during the comment period on the risk

assessment. The docket will also include comments on the revised risk assessment, and any risk

mitigation proposals submitted during Phase 5. For bensulide, a proposal was submitted by Gowan

Company, the technical registrant. Comments on mitigation or mitigation suggestions were submitted by

an environmental organization, an agricultural extension agent, and various golf course organizations.

This document and the process used to develop it are the result of a pilot process to facilitate

greater public involvement and participation in the reregistration and/or tolerance reassessment decisions

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

Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain

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

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

developed by the Tolerance Reassessment Advisory Committee (TRAC), a large multi-stakeholder

advisory body that advised the Agency on implementing the new provisions of the FQPA. The

reregistration and tolerance reassessment reviews for the organophosphate pesticides are following this

new process. 

Please note that the bensulide risk assessment and the attached Interim RED concern only this

particular organophosphate. This Interim RED presents the Agency’s reregistration decision except for

the decision on tolerance reassessment. Because the FQPA directs the Agency to consider available

information on the basis of cumulative risk from substances sharing a common mechanism of toxicity,

such as the toxicity expressed by the organophosphates through a common biochemical interaction with

cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire

organophosphate class of chemicals after completing the risk assessments for the individual

organophosphates. The Agency is working towards completion of a methodology to assess cumulative

risk and the individual risk assessments for each organophosphate are likely to be necessary elements of

any cumulative assessment. The Agency has decided to move forward with individual assessments and

to identify mitigation measures necessary to address those human health and environmental risks that

have already been attributed to current uses of bensulide. The Agency will issue the final tolerance

reassessment decision for bensulide once the cumulative assessment for all of the organophophates is

complete. 

This document contains generic and product-specific Data Call-In (DCI) notices that outline

further data requirements for this chemical. Registrants must respond to the DCIs issued by the Agency

within 90 days of receipt of this letter.

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, Jacqueline McQueen at (703) 308-8164.

Sincerely yours,

Lois A. Rossi, Director

Special Review and 

 Reregistration Division

Attachment

Interim Reregistration Eligibility Decision

for

Bensulide

TABLE OF CONTENTS

BENSULIDE TEAM ........................................................... i

GLOSSARY OF TERMS AND ABBREVIATIONS ................................. iii

EXECUTIVE SUMMARY ...................................................... 1

I. INTRODUCTION ....................................................... 4

II. CHEMICAL OVERVIEW ................................................. 6

A. Regulatory History .................................................. 6

B. Chemical Identification ............................................... 6

C. Use Profile ......................................................... 7

D. Estimated Usage of Pesticide .......................................... 8

III. SUMMARY OF BENSULIDE RISK ASSESSMENT ........................... 9

A. Human Health Risk Assessment ...................................... 10

1. Dietary Risk from Food ........................................ 10

a. Toxicity ................................................. 10

b. FQPA Safety Factor ....................................... 11

c. Population Adjusted Dose (PAD) ............................ 11

d. Exposure Assumptions .................................... 11

e. Food Risk Characterization ................................. 12

2. Dietary Risk from Drinking Water ............................... 13

a. Surface Water ........................................... 13

b. Ground Water ........................................... 13

c. Drinking Water Levels of Comparison (DWLOCs) ............. 14

3. Occupational and Residential Risk ............................... 16

a. Toxicity ................................................. 16

b. Exposure ................................................ 17

c. Occupational & Residential Handler Risk Summary ............ 19

1) Agricultural Handler Risk ............................. 19

2) Golf Course & Other Professional Turf Use Risk .......... 21

3) Post-Application Occupational Risk ..................... 25

4) Residential (Homeowner) Handler Risk .................. 26

5) Residential Post-Application Risk ...................... 27

4. Aggregate Risk ............................................... 28
B. Environmental Risk Assessment ...................................... 29

1. Environmental Fate and Transport ................................ 30

2. Risk to Birds and Mammals ..................................... 30

3. Risk to Aquatic Species ........................................ 31

IV. INTERIM RISK MANAGEMENT AND REREGISTRATION DECISION ....... 32

A. Determination of Interim Reregistration Eligibility ........................ 32

B. Summary of Phase 5 Comments and Responses .......................... 33

C. Regulatory Position ................................................. 34

1. FQPA Assessment ............................................. 34

a. “Risk Cup” Determination ................................. 34

b. Tolerance Summary ....................................... 35

2. Endocrine Disruptor Effects ..................................... 36

3. Required Label Modifications ................................... 37

a. Agricultural and Turf Uses: Occupational and Ecological Risk

Mitigation ............................................... 37

b. Homeowner Use: Homeowner and Ecological Risk 

Mitigation ............................................... 38

D. Regulatory Rationale ............................................... 38

1. Human Health Risk Mitigation .................................. 38

a. Dietary Mitigation ........................................ 38

1) Acute Dietary (Food) ................................. 38

2) Chronic Dietary (Food) ............................... 39

3) Drinking Water ..................................... 39

b. Occupational Risk Mitigation ............................... 39

1) Agricultural Uses .................................... 39

2) Golf Course and Professional Turf Uses ................. 40

c. Homeowner Risk Mitigation ................................ 41

1) Handler Risk ....................................... 41

2) Post-Application Risk ................................ 42

2. Environmental Risk Mitigation .................................. 42

E. Other Labeling Requirements ........................................ 43

1. Endangered Species Statement .................................. 43

2. Spray Drift Management ....................................... 43

V. WHAT REGISTRANTS MUST DO ........................................ 44

A. Manufacturing Use Products ......................................... 44

1. Additional Generic Data Requirements ............................ 44

2. Labeling Requirements for Manufacturing Use Products .............. 45

B. End-Use Products .................................................. 45

1. Additional Generic Data Requirements ............................ 45
2. Labeling Requirements for End-Use Products ....................... 45

C. Existing Stocks .................................................... 46

D. Required Labeling Changes Summary Table ............................ 47

VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM ................... 57

VII. APPENDICES .......................................................... 59

Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR INTERIM

REREGISTRATION ..................................... 61

Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND 

STUDIES USED TO MAKE THE INTERIM 

REREGISTRATION DECISION ........................... 71

Appendix C. TECHNICAL SUPPORT DOCUMENTS ..................... 79

Appendix D. CITATIONS CONSIDERED TO BE PART OF THE 

DATA BASE SUPPORTING THE INTERIM 

REREGISTRATION DECISION (BIBLIOGRAPHY) .......... 81

Appendix E. GENERIC DATA CALL-IN ............................... 101

Appendix F. PRODUCT SPECIFIC DATA CALL-IN ..................... 105

Appendix G. EPA’S BATCHING OF BENSULIDE PRODUCTS FOR 

MEETING ACUTE TOXICITY DATA REQUIREMENTS 

FOR REREGISTRATION ................................ 113

Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN ....... 119

Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND

ELECTRONICALLY AVAILABLE FORMS ................. 121

i

BENSULIDE TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

Kit Farwell

Jeffery Dawson

Christina Swartz

Michael Metzger

Environmental Fate Risk Assessment

Stephanie Syslo

Nicholas Mastrota

Use and Usage Analysis

Virginia Dietrich

James Saulmon

Registration Support

Jim Tompkins

Risk Management

Loan Phan

Jacqueline McQueen
ii
iii

GLOSSARY OF TERMS AND ABBREVIATIONS

AE Acid Equivalent

a.i. Active Ingredient

AGDCI Agricultural Data Call-In

ai Active Ingredient

aPAD Acute Population Adjusted Dose

AR Anticipated Residue

ARC Anticipated Residue Contribution 

BCF Bioconcentration Factor 

CAS Chemical Abstracts Service

CI Cation

CNS Central Nervous System

cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula

CFR Code of Federal Regulations

CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In

DEEM Dietary Exposure Evaluation Model

DFR Dislodgeable Foliar Residue

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, noncarcinogenic health effects

are not anticipated to occur.

DWLOC Drinking Water Level of Comparison.

EC Emulsifiable Concentrate Formulation

EEC Estimated Environmental Concentration. The estimated pesticide concentration in an

environment, such as a terrestrial ecosystem.

EP End-Use Product

EPA U.S. Environmental Protection Agency

FAO Food and Agriculture Organization

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

FQPA Food Quality Protection Act

FOB Functional Observation Battery

G Granular Formulation

GENEEC Tier I Surface Water Computer Model

GLC Gas Liquid Chromatography

GLN Guideline Number
iv

GLOSSARY OF TERMS AND ABBREVIATIONS

GM Geometric Mean

GRAS Generally Recognized as Safe as Designated by FDA

HA Health Advisory (HA). The HA values are used as informal guidance to municipalities

and other organizations when emergency spills or contamination situations occur.

HAFT Highest Average Field Trial

HDT Highest Dose Tested

IR Index Reservoir

LC50 Median Lethal Concentration. A statistically derived concentration of a substance that

can be expected to cause death in 50% of test animals. It is usually expressed as the

weight of substance per weight or volume of water, air or feed, e.g., mg/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.

LEL Lowest Effect Level

LOC Level of Concern

LOD Limit of Detection 

LOAEL Lowest Observed Adverse Effect Level

MATC Maximum Acceptable Toxicant Concentration

MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to

regulate contaminants in drinking water under the Safe Drinking Water Act.

mg/kg/day Milligram Per Kilogram Per Day

mg/L Milligrams Per Liter

MOE Margin of Exposure 

MP Manufacturing-Use Product

MPI Maximum Permissible Intake

MRID Master Record Identification (number). EPA's system of recording and tracking studies

submitted.

NA Not Applicable

N/A Not Applicable

NAWQA USGS National Water Quality Assessment

NOEC No Observable Effect Concentration

NOEL No Observed Effect Level

NOAEL No Observed Adverse Effect Level

NPDES National Pollutant Discharge Elimination System

NR Not Required

OP Organophosphate
v

GLOSSARY OF TERMS AND ABBREVIATIONS

OPP EPA Office of Pesticide Programs

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances

Pa pascal, the pressure exerted by a force of one newton acting on an area of one square

meter.

PAD Population Adjusted Dose

PADI Provisional Acceptable Daily Intake

PAG Pesticide Assessment Guideline

PAM Pesticide Analytical Method

PCA Percent Crop Area

PDP USDA Pesticide Data Program

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval

ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million

PRN Pesticide Registration Notice

PRZM/

EXAMS Tier II Surface Water Computer Model 

Q1* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk

Model

RAC Raw Agriculture Commodity

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose

RQ Risk Quotient

RS Registration Standard

RUP Restricted Use Pesticide

SAP Science Advisory Panel

SCI-GROW Tier I Ground Water Computer Model

SF Safety Factor

SLC Single Layer Clothing

SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)

TC Toxic Concentration. The concentration at which a substance produces a toxic effect. 

TD Toxic Dose. The dose at which a substance produces a toxic effect.

TEP Typical End-Use Product

TGAI Technical Grade Active Ingredient

TLC Thin Layer Chromatography
vi

GLOSSARY OF TERMS AND ABBREVIATIONS

TMRC Theoretical Maximum Residue Contribution

torr A unit of pressure needed to support a column of mercury 1 mm high under standard

conditions.

TRR Total Radioactive Residue

UF Uncertainty Factor

μg/g Micrograms Per Gram

μg/L Micrograms Per Liter

USDA United States Department of Agriculture

USGS United States Geological Survey

UV Ultraviolet ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
1

EXECUTIVE SUMMARY

EPA has completed its review of public comments on the revised risk assessments and is issuing

its risk management decisions for bensulide. The decisions outlined in this document do not include the

final tolerance reassessment decision for bensulide; however, some tolerance actions will be undertaken

prior to completion of the final tolerance reassessment. A single tolerance will be revoked now, because

there are no currently registered uses; one tolerance will be modified, and several other commodity

definitions will be corrected. The final tolerance reassessment decision for this chemical will be issued

once the cumulative assessment for all of the organophosphates is complete. The Agency may need to

pursue further risk management measures for bensulide once the cumulative assessment is finalized. 

The revised risk assessments are based on review of the required target data base supporting the

use patterns of currently registered products and new information received. The Agency invited

stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the

Agency issued its risk mitigation decision on bensulide. After considering the revised risks, as well as

mitigation proposed by Gowan Company, the technical registrant of bensulide, and comments and

mitigation suggestions from other interested parties including the Natural Resources Defense Council,

several golf course organizations, and an agricultural extension agent, EPA developed its risk

management decision for uses of bensulide that pose risks of concern. This decision is discussed fully in

this document. 

Bensulide is an organophosphate herbicide used on a variety of weeds, first registered in 1964

for pre-emergence control of crabgrass and annual bluegrass in turf. In 1968 bensulide was registered

for weed control in food crops. Bensulide turf uses include golf courses and home lawns, and

ornamentals. Use data from 1987 to 1996 indicate an average domestic use of approximately 550,000

lbs a.i. per year.

Overall Risk Summary

EPA’s human health risk assessment for bensulide indicates some risk concerns. Food risk, both

acute and chronic, is well below the Agency’s level of concern. Similarly, drinking water risk estimates

based on screening models, from both ground and surface water for acute and chronic exposures, is not

of concern for all populations. There are, however, concerns for workers who mix, load, and apply

bensulide to agricultural sites, golf courses, and home lawns. Additionally, there are concerns for

homeowners who apply bensulide, and for children entering areas treated with bensulide if label

requirements are not followed properly. Also, EPA has identified chronic risk to birds and mammals

that exceed the Agency’s level of concern. 

To mitigate risks of concern posed by the uses of bensulide, EPA considered the mitigation

proposal submitted by the technical registrant, as well as comments and mitigation ideas from other

interested parties, and has decided on a number of label amendments to address the worker, residential,
2

and ecological concerns. Results of the risk assessments, and required label amendments to mitigate

those risks, are presented in this Interim RED. 

Dietary Risk

Acute and chronic dietary risk assessments for food and drinking water do not exceed the

Agency’s level of concern; therefore, no mitigation is warranted at this time for any dietary exposure to

bensulide. 

Occupational Risk- Agricultural Uses

Occupational exposure to bensulide is of concern to the Agency, and it has been determined that

a number of mitigation measures are required. For the agricultural uses of bensulide, several

mixer/loader/ applicator risk scenarios currently exceed the Agency’s level of concern (i.e., MOEs are

less than 100). EPA believes these risks can be mitigated to an acceptable level with the following label

restrictions: addition of personal protective equipment or the use of closed systems, and restriction of

chemigation to use only in certain states, where extensive data show that the number of acres treated is

significantly lower than the Agency’s standard assumptions. There are no re-entry risks of concern for

workers entering bensulide-treated agricultural sites. Therefore, with the addition of the label

restrictions and amendments detailed in this document, the Agency has determined that, until the

outcome of the cumulative risk assessment for all of the organophosphates has been decided, all

currently registered agricultural uses of bensulide may continue.

Occupational Risk- Turf Uses

 

Occupational exposure from the turf uses of bensulide is also of concern. Most risks to

professional applicators of bensulide on turf stem from use of high exposure, handheld equipment. 

Although the addition of respirators can adequately protect against inhalation exposure, combined

dermal and inhalation risks from most handheld equipment cannot be adequately mitigated – therefore,

all but one of the handheld application methods that have risk concerns are being prohibited. The

remaining hand-held method that has a risk concern is being retained for spot treatment only; this will

mitigate risk to an acceptable level. The treatment of large turf areas other than golf courses is also being

prohibited. This prohibition will help to mitigate not only the worker risk but also risk to children when

bensulide is not applied properly, and the ecological risk discussed below. 

For all remaining mixer and/or loader turf uses, respirators and gloves are required. For

commercial or “for hire” applicators (a group that is likely to have multiple exposures) who apply

bensulide to turf, respirators are required. For workers applying granulars with a push spreader,

coveralls, gloves and a respirator are required. 
3

Residential Risk

Risks to homeowner handlers using a handheld rotary application method (e.g., bellygrinder) to

apply granular formulations of bensulide, and post-application risks to children when bensulide is not

properly watered-in, are of concern to the Agency. The addition of label language to homeowner

products prohibiting use of any handheld application method, as well as specific language directing

homeowners to water in the herbicide as soon as possible, for efficacy and safety purposes, will mitigate

these remaining risks. 

Ecological Risk

Ecological risks are also of concern to the Agency. Turf use of bensulide poses greater risk

concerns to aquatic, terrestrial and avian species than the agricultural uses. The high turf use rates, the

persistence of the chemical, and the potential for surface water runoff all contribute to the ecological

concerns from turf. Of particular concern is the potential for chronic avian risk, especially because avian

species tend to be attracted to large turf areas (e.g., golf course fairways, parks) and may nest, feed or

forage near or on these areas.

The mitigation measures that the Agency is requiring for the turf uses are expected to mitigate the

potential for ecological risks. These measures include: prohibiting use on large non-golf course turf sites

(e.g., parks and recreational areas), restriction of the golf course fairway use to a single grass type (i.e.,

bentgrass), and to certain states where bensulide serves a limited, but important purpose, and restriction

of the number of fairway applications to one. To address at least in part the chronic avian risk, the

Agency is further requiring that the fairway application be limited to the fall, to minimize exposure to

birds during the breeding season, thereby mitigating the risk of reproductive impairment. While the

Agency recognizes that this will not alleviate the risk entirely, it will provide some degree of protection. 

For the turf uses of bensulide, the Agency has determined that, with the adoption of all of the

label amendments and clarifications noted in this document, these uses may continue until the outcome of

the cumulative assessment of all of the organophosphates has been decided.

The Agency is issuing this Interim Reregistration Eligibility Document (RED) for bensulide, as

announced in a Notice of Availability published in the Federal Register. This Interim RED document

includes guidance and time frames for complying with any required label changes for products containing

bensulide. Note that there is no comment period for this document, and that the time frames for

compliance with the required changes outlined in this document are shorter than those given in previous

REDs. As part of the process discussed by the TRAC, which sought to open up the process to

interested parties, the Agency’s risk assessments for bensulide have already been subject to numerous

public comment periods, and a further comment period for bensulide was deemed unnecessary. The

Phase 6 of the pilot process did not include a public comment period; however, for some chemicals, the

Agency may provide for another comment period, depending on the content of the risk management
4

decision. With regard to complying with the requirements in this document, the Agency has shortened

this time period so that the risks identified herein are mitigated as quickly as possible. Neither the

tolerance reassessment nor the reregistration eligibility decision for bensulide can be considered final,

however, until the cumulative risk assessment for all organophosphate pesticides is complete. The

cumulative assessment may result in further required risk mitigation measures for bensulide.

I. INTRODUCTION

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to

accelerate the reregistration of products with active ingredients registered prior to November 1, 1984. 

The amended act calls for the development and submission of data to support the reregistration of an

active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency

(referred to as EPA or “the Agency”). Reregistration involves a thorough review of the scientific

database underlying a pesticide’s registration. The purpose of the Agency’s review is to reassess the

potential hazards arising from the currently registered uses of the pesticide; to determine the need for

additional data on health and environmental effects; and to determine whether the pesticide meets the

“no unreasonable adverse effects” criteria of FIFRA. 

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This

Act amends FIFRA to require tolerance reassessment during reregistration. It also requires that by

2006, EPA must review all tolerances in effect on the day before the date of the enactment of the

FQPA, which was August 3, 1996. FQPA also amends the FFDCA to require a safety finding in

tolerance reassessment based on factors including an assessment of cumulative effects of chemicals with

a common mechanism of toxicity. Bensulide belongs to a group of pesticides called organophosphates,

which share a common mechanism of toxicity - they all affect the nervous system by inhibiting

cholinesterase. Although FQPA significantly affects the Agency’s reregistration process, it does not

amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its reregistration

program while it resolves the remaining issues associated with the implementation of FQPA. 

This document presents the Agency’s revised human health and ecological risk assessments; its

progress toward tolerance reassessment; and the interim reregistration eligibility decision for bensulide. 

It is intended to be only the first phase in the reregistration process for bensulide. The Agency will

eventually proceed with its assessment of the cumulative risk of the OP pesticides.

 The implementation of FQPA has required the Agency to revisit some of its existing policies

relating to the determination and regulation of dietary risk, and has also raised a number of new issues

for which policies need to be created. These issues were refined and developed through collaboration

between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was

composed of representatives from industry, environmental groups, and other interested parties. The
5

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. 

In addition to the policy issues that resulted from the TRAC process, the Agency published in

the Federal Register on August 12, 1999 a draft Pesticide Registration Notice that presents EPA’s

proposed approach for managing risks from organophosphate pesticides to occupational users. This

notice describes the Agency’s baseline approach to managing risks to handlers and workers of

organophosphate pesticides. Generally, basic protective measures such as closed mixing and loading

systems, enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be

required for most uses where current risk assessments indicate a risk and such protective measures are

feasible. The 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 RED are consistent with that draft Pesticide

Registration Notice. 

This document consists of six sections. Section I contains the regulatory framework for

reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for

public comment on science policy issues for the organophosphate pesticides and the worker risk

management PR notice. Section II provides a profile of the use and usage of the chemical. Section III

gives an overview of the revised human health and environmental effects risk assessments resulting from

public comments and other information. Section IV presents the Agency's interim reregistration eligibility

and risk management decisions. Section V summarizes required label changes based on the risk

mitigation measures outlined in Section IV. Section VI provides information on how to access related

documents. Finally, the Appendices lists Data Call-In (DCI) information. The revised risk assessments
6

S

P

S

OCH(CH3)

2

OCH(CH3)

2

N

H

S

O

O

and related addenda are not included in this document, but are available on the Agency's web page

www.epa.gov/pesticides/op, and in the Public Docket.

II. CHEMICAL OVERVIEW

A. Regulatory History

Bensulide was first registered in the United States in 1964 for pre-emergence control of

crabgrass and annual blue grass on turf. In 1968 bensulide was registered for weed control in food

crops.

B. Chemical Identification

BENSULIDE:

! Common Name: Bensulide

! Bensulide: [S-(O,O-diisopropyl phosphorodithioate) ester of N-(2-

mercapto)benzenesulfonamide]

! Chemical family: Organophosphate

! Case number: 2035

! CAS registry number: 741-58-2

! OPP chemical code: 009801

! Empirical formula: C14H24NO4PS3

! Molecular weight: 397.5
7

! Trade and other names: Prefar® 4-E; Prefar® 6-E; Bensumec® 4-LF; PreSan® Granular 7G & 12.5G; Betasan® 4-E, 3G

&12.5G

! Basic manufacturer: Gowan Company (technical registrant)

Pure bensulide is a colorless solid with a melting point of 34.4°C. Technical bensulide is a

viscous amber liquid at temperatures above 34°C and a solid below this temperature. Bensulide is

soluble in water at 25 ppm at 20°C and is miscible with acetone, ethanol, 4-methylpentan-2-one, and

xylene.

C. Use Profile

The following information is based on the currently registered uses of bensulide. 

Type of Pesticide: Herbicide.

Summary of Use Sites:

Food: Bensulide is used for preemergent control of annual grasses and broadleaf weeds

in agricultural crops (60-65% of all use). Current registered use sites are: carrots,

fruiting vegetables, leafy vegetables (mostly head lettuce), dry bulb vegetables (onions),

cucurbits (mostly melons), and cole crops (cauliflower, cabbage, broccoli, broccolini,

broccoflower). 

Other agricultural sites: Used on field grown herbaceous plants and field grown bulbs. 

Residential: Products containing bensulide are intended for outdoor homeowner use on

lawns and ornamentals, and application by professional lawncare operators to lawns,

ornamentals, parks, and recreation areas.

Public Health: None.

Other Nonfood: Terrestrial non-food crops (i.e., turf, primarily golf course greens and

tees).

Target Pests: Weeds include annual bluegrass; annual broadleaf; annual grasses;

barnyardgrass; burning nettle; canarygrass; crabgrass; etc. 

Formulation Types Registered: In addition to the technical, there are two end-use

formulations: a granular formulation and an emulsifiable concentrate.
8

Method and Rates of Application:

Equipment - Groundboom, tractor drawn spreader, drip or sprinkler irrigation

(chemigation), low pressure handwand, high pressure handwand, backpack sprayer, low

pressure/high volume turfgun, push spreader, hand-held rotary spreader (bellygrinder).

Method and Rate - Soil incorporated, applied preemergent or preplant. 

• Agricultural use rate is typically 5-6 lbs ai/acre, and the 6 lb rate is often used. 

In the southwest deserts, may be applied twice per year at up to 6 lbs/acre, for a

maximum of 12 lbs ai/acre/year. The ornamental use for field grown plants and

bulbs is applied at rates up to 9 lbs ai/acre, one time per year. Applied by

groundboom or with sprinkler and chemigation systems. 

• Turf use rates are typically 7.5 to 12.5 lbs ai/acre per application, applied twice

per year, for a maximum of 25 lbs ai/year.

Timing - preemergence; preplant.

Use Classification: Bensulide is a general use product, registered for a variety of

terrestrial food crops, terrestrial non-food crops, and outdoor residential uses.

D. Estimated Usage of Pesticide

This section summarizes the best estimates available for many of the pesticide uses of bensulide,

based on available pesticide usage information for 1987 through 1996. A full listing of all uses of

bensulide, with the corresponding use and usage data for each site, has been completed and is in the

“Quantitative Use Assessment” document, which is available in the public docket. The data, reported

on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the variability

in using data from various information sources. Approximately 550,000 lbs a.i. of bensulide are used

annually, according to Agency and registrant estimates.
9

Table 1. Bensulide Estimated Usage for Representative Sites

Crop Lbs. Active

Ingredient Applied

(Wt. Avg.)1

Percent Crop

Treated (Likely

Maximum)

Percent Crop

Treated (Wt.

Avg.)

Cantaloupes 36,000 24% 22%

Carrots 9,000 3% 2%

Celery 6,000 13% 4%

Cole Crops (broccoli, cabbage, cauliflower) 37,000 10% 5%

Cucumbers (fresh and process) 33,000 9% 6%

Honeydew 16,000 34% 18%

Lettuce 67,000 19% 7%

Onions 99,000 23% 11%

Peppers (bell, hot, and sweet) 32,000 12% 4%

Pumpkins 6,000 35% 19%

Squash 12,000 38% 21%

Watermelons 12,000 9% 5%

Golf Courses 68,000 <2% <2%

Lawn Care Operators (including residential

and landscape)

20,000 <1% <1 %

Lawn, Homeowners <100,000 <2% <2%

Public/Government 1,000 unknown unknown

Field grown herbaceous plants and bulbs <1,800 unknown unknown

1 Weighted Average is based on data for 1987-1996; the most recent years and more reliable data are weighted more

heavily.

III. SUMMARY OF BENSULIDE RISK ASSESSMENT

Following is a summary of EPA’s revised human health and ecological risk findings and

conclusions for the organophosphate pesticide bensulide, as fully presented in the documents, “Bensulide

Revised HED Chapter for the Reregistration Eligibility Decision Document,” dated June 15, 1999 (and

addenda thereto), and “Revised EFED Chapter for Bensulide,” dated June 14, 1999 (and addenda

thereto). The purpose of this summary is to assist the reader by identifying the key features and findings

of these risk assessments, and to better understand the conclusions reached in the assessments.
10

These risk assessments for bensulide were presented at a June 16, 1999 Technical Briefing,

which was followed by an opportunity for public comment on risk management for this pesticide. The

risk assessments presented here form the basis of the Agency’s risk management decision for bensulide

only; the Agency must complete a cumulative assessment of the risks of all the organophosphate

pesticides before any final decisions can be made.

A. Human Health Risk Assessment

EPA issued its preliminary risk assessments for bensulide in August, 1998 (Phase 3 of the

TRAC process). In response to comments and studies submitted during Phase 3, the risk assessments

were updated and refined. The first five revisions noted below occurred as a result of comments

received during Phase 3 and prior to the technical briefing for bensulide. During Phase 6 of the TRAC

process; that is, after all public comment periods were over, the Agency incorporated the last point

noted below into the risk assessment. The last revision was done as a result of an internal policy change. 

Major revisions to the human health risk assessment are listed below:

- Use of a 21-day dermal toxicity study to determine a dermal NOAEL for use in the

occupational and residential risk assessment.

- Use of data from a transferable and total turf residue study in the assessment of postapplication occupational and residential risks.

- Use of separate toxicological endpoints for dermal and inhalation exposures for the

occupational and residential handler assessments.

- Addition of exposure scenarios to the occupational handler risk assessment based on registrant

comments regarding bensulide use on golf courses. 

- Consideration of exposure to children from non-dietary ingestion after contact with bensulidetreated turf.

 - Use of GENEEC instead of PRZM-EXAMS to estimate environmental concentrations

resulting from turf uses, for use in the drinking water assessment.

1. Dietary Risk from Food

a. Toxicity

The Agency has reviewed all toxicity studies submitted and has determined that the toxicity

database is complete, and that it supports an interim reregistration eligibility determination for all currently

registered uses. Confirmatory data are being required and are included in section V of this document. 
11

Further details on the toxicity of bensulide can be found in the June 16, 1999 Human Health Risk

Assessment and subsequent addenda. A brief overview of the studies used for the dietary risk

assessment is outlined in Table 2 in this document.

b. FQPA Safety Factor

The FQPA Safety Factor was reduced to 1X. The toxicity database includes an acceptable

two-generation reproduction study in rats and acceptable prenatal developmental toxicity studies in rats

and rabbits. These studies show no increased sensitivity to fetuses as compared to maternal animals

following acute in utero exposure in the developmental rat and rabbit studies and no increased sensitivity

to pups as compared to adults in a multi-generation reproduction study in rats. There was no evidence

of abnormalities in the development of the fetal nervous system in the pre/post natal studies. Adequate

actual data, surrogate data, and/or modeling outputs are available to satisfactorily assess dietary and

residential exposure and to provide a screening level drinking water exposure assessment. The

assumptions and models used in the assessments do not underestimate the potential risk for infants and

children. Therefore, the additional 10X factor as required by FQPA was reduced to 1.

c. Population Adjusted Dose (PAD)

The PAD is a relatively new term that characterizes the dietary risk of a chemical, and reflects

the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety

factor (i.e., RfD/FQPA safety factor). In the case of bensulide, the FQPA safety factor is 1; therefore,

the acute or chronic RfD = the acute or chronic PAD. A risk estimate that is less than 100% of the acute

or chronic PAD does not exceed the Agency’s risk concern. 

d. Exposure Assumptions

Revised acute and chronic dietary risk analyses for bensulide were conducted with the Dietary

Exposure Evaluation Model (DEEMTM). DEEM incorporates consumption data generated in USDA’s

Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-91. 

The Tier I acute dietary analysis used tolerance levels and assumed 100% of the registered

commodities were treated. It is noted that bensulide residues have never been detected in field trials. 

The chronic dietary analysis used tolerance level residues and was refined with weighted average percent

crop treated data. FDA monitoring data was not used to refine the assessment, given the low chronic

dietary risk estimates based just on the tolerance-level residues and percent crop treated information.
12

Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary

Risk Assessment of Bensulide

Assessment Dose Endpoint Study UF FQPA 

Safety

Factor

PAD

Acute

Dietary

NOAEL =

15

mg/kg/day

Plasma ChE

inhibition

Acute rat

neurotoxicity

(MRID

43195901) 

100 1X 0.15

mg/kg/day

Chronic

Dietary

NOAEL =

0.5

mg/kg/day

Plasma, brain

ChE

inhibition,

decreased

body weight

gain

Chronic oral 

dog (MRIDs

44066401,

44052704) 

100 1X 0.005

mg/kg/day

e. Food Risk Characterization

Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population

Adjusted Dose does not exceed the Agency’s risk concerns. The bensulide acute dietary risk from food

is well below the Agency’s level of concern –that is, less than 100% of the acute PAD is utilized. For

example, for the most exposed subgroups, children (1-6 years) and infants (<1 year), the % acute PAD

values are less than 1% at the 95th percentile of exposure. The 95th percentile is reported here, because

a Tier I deterministic assessment was conducted. A probabilistic assessment was not conducted at this

time because the results of the Tier I assessment were so low. 

Similarly, the chronic dietary risk from food alone is well below the Agency’s level of concern. 

For the most exposed subgroups, the % chronic PAD values are also less than 1%. In summary, both

acute and chronic dietary exposure and risk associated with bensulide-treated foods are considered to

be well below the Agency’s level of concern, even when tolerance-level residue values are used. 

Refinements to the dietary analyses can be made using monitoring data for the chronic dietary

analysis, and a probabilistic assessment for acute dietary analysis; however, given the low dietary risk

estimates based on tolerance level residues and percent crop treated information, the Agency

determined that further refinements are not warranted at this time. Refinements will be considered when

the cumulative assessment for all of the organophosphates is conducted.
13

2. Dietary Risk from Drinking Water

Drinking water exposure to pesticides can occur through ground water and surface water

contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses

either modeling or actual monitoring data, if available, to estimate those risks. Modeling is considered to

be an unrefined assessment and provides a high-end estimate of risk. In the case of bensulide, no

monitoring data for either ground or surface water were available; therefore, modeling was used to

estimate drinking water risks from these sources. 

The GENEEC and PRZM-EXAMS models were used to estimate surface water

concentrations, and SCI-GROW was used to estimate groundwater concentrations. All of these are

considered to be screening models, with the PRZM-EXAMS model being somewhat more refined than

the other two. 

Based on environmental fate data, bensulide is very persistent but not mobile in soil. There is

uncertainty as to the fate of bensulide degradates in soil; however, based on the persistent qualities of the

bensulide parent, the degradates are also expected to persist. 

a. Surface Water

Based on its environmental fate characteristics, bensulide has the potential to be transported in

water and on suspended sediment in runoff to surface waters. In its initial assessment, EPA used a Tier

II PRZM-EXAMS screening model to estimate the upper-bound bensulide concentrations in drinking

water derived from surface water for the agricultural as well as the turf uses. This model, in general, is

based on more refined, less conservative assumptions than the Tier I GENEEC screening model. 

However, since this assessment was completed, the Agency has determined that the scenario used in

PRZM-EXAMS does not have the appropriate parameters to accurately model turf runoff; therefore,

the GENEEC model was used to model turf uses. PRZM-EXAMS continues to be used for agricultural

uses.

The updated environmental concentrations for the turf uses using the GENEEC model are found

in the 2/10/00 memo entitled, “Revised Estimated Environmental Concentrations in Ground and Surface

Water for Bensulide used on Golf Course Fairways.” The memo presents two scenarios for the turf use:

one scenario modeled the high use rate and the maximum number of applications (i.e., 2) per year

currently allowed on the label, the other modeled the high use rate and one application per year, to

reflect proposed mitigation for ecological effects discussed in Section IV of this document.

 

b. Ground Water

Bensulide is not expected to leach to ground water because its high soil sorption affinity indicates

that it will bind to soil organic matter. A Tier I screening model, SCI-GROW, was used to estimate
14

drinking water concentrations derived from ground water. There were two modeled scenarios: the first

used maximum application rates, maximum number of applications allowed per year, irrigation, and very

shallow ground water to simulate “high-end” exposures. The second differed in that it used only one

application per year, to reflect proposed mitigation for ecological effects discussed in Section IV of this

document. 

c. Drinking Water Levels of Comparison (DWLOCs)

To determine the maximum allowable contribution of water-containing pesticide residues

permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by food

(and if appropriate, residential uses) then determines a “drinking water level of comparison”(DWLOC)

to determine whether modeled or monitoring levels exceed this level. The Agency uses the DWLOC as

a surrogate to capture risk associated with exposure from pesticides in drinking water. The DWLOC is

the maximum concentration in drinking water which, when considered together with dietary exposure,

does not exceed a level of concern. 

The results of the Agency’s drinking water analysis are summarized here. Details of this analysis,

which used screening models, are found in the HED Human Health Risk Assessment, dated June 16,

1999 and the memo entitled, “Addendum to HED Chapter for the Reregistration Eligibility Decision

Document. New Estimated Water Concentrations from EFED,” dated 2/11/00. 

For acute risk, the potential drinking water exposure derived from either ground or surface

water is not of concern for all populations. That is, the environmental concentrations resulting from both

the agricultural uses and turf uses (at either 1 application per year or two applications per year) are well

below the DWLOCs. The table below presents the calculations for the acute drinking water assessment.

Table 3. Summary of DWLOC Calculations for Acute Risk

Population

Subgroup

Acute PAD

(mg/kg/day)

Food

Exposure

(mg/kg/day

)

Allowable

Water

Exposure

(mg/kg/day)

Ground

Water1

(ppb)

(SCIGROW)

Surface

Water2

(ppb)

(GENEEC)

Surface

Water 

(ppb)3

(PRZMEXAMS)

DWLOC

(ppb)

U.S.

Population 0.15 0.000059 0.149941 0.5/1.0 106/189 165 5248

Females 

13-19 0.15 0.000060 0.14994 0.5/1.0 106/189 165 4498

Children 

1-6 0.15 0.000122 0.149878 0.5/1.0 106/189 165 1499

1

 The value of 0.5 ppb is with 1 turf application, the 1.0 ppb value is with 2 turf applications per year.

2

 The value of 106 ppb is with 1 turf application, 189 ppb is with 2 turf applications per year. 

3

 The value of 165 ppb is with broadcast vegetable application.
15

For chronic risk, potential exposure to drinking water derived from groundwater is not of

concern for all populations. Groundwater estimates are well below the DWLOC regardless of whether

one or two turf applications per year are applied. Also, potential exposure to drinking water derived

from surface water resulting from the turf uses is not of concern, when either one or two applications per

year are used. In either case, the environmental concentrations are below the DWLOC.

For chronic risk from the agricultural uses of bensulide, potential exposure to drinking water

derived from surface water results in estimated environmental concentrations that are higher than the

DWLOCs for two groups: females (13+, nursing) and non-nursing infants (< 1 year). For the general

U.S. population, environmental concentrations are not of concern; that is, they are less than the

DWLOC. For the group “females 13+, nursing,” the estimated environmental concentration is only

slightly higher than the DWLOC, and the difference is considered to be insignificant. For the group

“non-nursing infants,” the estimated environmental concentration is approximately three times higher than

the DWLOC. 

Even though the DWLOC is exceeded for some populations, the Agency has determined that

this chronic drinking water risk estimate from the agricultural uses of bensulide is not of concern. In

making this determination, the Agency considered the fact that PRZM-EXAMS is a Tier II model, and

is considered to be a screening-level assessment. The results, even though they exceed in some cases,

are considered to be health-protective because the estimated drinking water exposures are based on

conservative modeling estimates and are expected to be higher than those actually found in drinking

water. Also, bensulide is used on agricultural crops primarily in the Southwestern United States, where

the climate is dry and rainfall is low. In these areas, surface water run-off is not expected to occur in

significant amounts. The table below presents the calculations for the chronic drinking water assessment.
16

Table 4. Summary of DWLOC Calculations for Chronic Risk

Population

Subgroup

Chronic

PAD

(mg/kg/day)

Food

Exposure

(mg/kg/day)

Allowable

Water

Exposure

(mg/kg/day)

Ground

Water

(ppb)1

Surface

Water

(ppb)2 ,4

(GENEEC)

Surface

Water

(ppb)3

(PRZMEXAMS)

DWLOC

(ppb)

U.S.

Population 0.005 0.000015 0.004985 0.5/1.0 19/34 158 174

Females

(13+,

nursing)

0.005 0.000019 0.004981 05/1.0 19/34 158 150

Nonnursing

Infants 

(<1 yr)

0.005 0.000039 0.004961 0.5/1.0 19/34 158 50

1

 The value of 0.5 ppb is with 1 turf application/year, the 1.0 ppb value is with 2 turf applications/year.

2

 The value of 19 ppb is with 1 turf application/year, 34 ppb is with 2 turf applications/year.

3

 The value of 158 ppb is with broadcast vegetable application.

4 GENEEC values have been adjusted per SOP 99-5 to obtain a long-term average estimate. This SOP is cited and

discussed in more detail in the February 11, 2000 addendum to the HED chapter available in the public docket.

3. Occupational and Residential Risk

Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a

pesticide, or re-entering treated sites. Residents or homeowners can be exposed to a pesticide through

mixing, loading, or applying a pesticide, or through entering or performing other activities on treated

areas. Occupational handlers of bensulide include: individual farmers or growers who mix, load, and/or

apply pesticides, professional or custom agricultural applicators, and lawncare and turf management

professionals who treat either individual areas (e.g., a golf course superintendent who is responsible for

his own course) or “for hire” handlers who treat multiple areas, and who may be exposed over multiple

days. Residential handlers include homeowner applicators treating their own lawns. Bensulide exposure

to adults and children can also occur from exposure to treated lawns or other turf areas. Risk for all of

these potentially exposed populations is measured by a Margin of Exposure (MOE) which determines

how close the occupational or residential exposure comes to a No Observed Adverse Effect Level

(NOAEL). Generally, MOEs greater than 100 do not exceed the Agency’s risk concern.

a. Toxicity

The toxicity of bensulide is integral to assessing the occupational and residential risk. All risk

calculations are based on the most current toxicity information available for bensulide, including a 21-day

dermal toxicity study. The toxicological endpoints, and other factors used in the occupational and

residential risk assessments for bensulide are listed below. 
17

Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human

Occupational and Residential Risk Assessments for Bensulide

Assessment Dose Endpoint Study Absorption

factor

 Short-term

dermal

NOAEL = 50

mg/kg/day

Plasma, brain

ChE inhibition

21-day dermal rat 

(MRIDs 44801101,

44809401) 

N/A

Intermediateterm dermal NOAEL = 50

mg/kg/day

Plasma, brain

ChE inhibition

21-day dermal rat

(MRIDs 44801101,

44809401)

N/A

Short-term

inhalation

Oral NOAEL=

5.5 mg/kg/day

maternal plasma

ChE inhibition 

developmental oral rat

(MRID 00146585)

100%

Intermediate -

term inhalation

Oral NOAEL=

0.5 mg/kg/day

plasma ChE

inhibition,

decreased body

weight gain. 

chronic oral dog

(MRIDs 44066401,

44052704)

100%

Non-dietary

ingestion

(children) 

NOAEL = 15

mg/kg/day

Plasma ChE acute rat neurotoxicity

(MRID 43195901) 

N/A

b. Exposure

Chemical-specific exposure data were not available for bensulide, so risks to pesticide handlers

were assessed using data from the Pesticide Handlers Exposure Database (PHED), and standard

assumptions about average body weight, work day, daily areas treated, volume of pesticide used, etc. to

calculate risk estimates. The quality of the data and exposure factors represents the best sources of data

currently available to the Agency for completing these kinds of assessments; the application rates are

derived directly from bensulide labels. The exposure factors (e.g., body weight, amount treated per day,

protection factors, etc.) are all standard values that have been used by the Agency over several years,

and the PHED unit exposure values are the best available estimates of exposure. Some PHED unit

exposure values are high quality while others represent low quality, but are the best available data. The

quality of the data used for each scenario assessed is discussed in the Human Health Assessment

document for bensulide, which is available in the public docket. 

Anticipated use patterns and application methods, range of application rates, and daily amount

treated were derived from current labeling. Application rates specified on bensulide labels range from 3

to 6 pounds of active ingredient per acre in agricultural settings, and from 7.5 to 12.5 pounds of active
18

ingredient per acre on turf. The Agency typically uses acres treated per day values that are thought to

represent 8 solid hours of application work for specific types of application equipment. However, as the

registrant supplied different values on acres treated per day for chemigation (40 acres of field typically

applied per day by an applicator versus 350 acres potentially applied per day by an applicator) and golf

courses (7 acres of greens and tees as opposed to 40 acres for an entire golf course), the Agency

included these values in its assessment.

Occupational handler exposure assessments are conducted by the Agency using different levels

of personal protection. The Agency typically evaluates all exposures with minimal protection and then

adds additional protective measures using a tiered approach to obtain an appropriate MOE (i.e., going

from minimal to maximum levels of protection). The lowest tier is represented by the baseline exposure

scenario, followed by, if required (i.e., MOEs are less than 100), increasing levels of risk mitigation

(personal protective equipment (PPE) and engineering controls (EC)). The current labels for bensulide

require handlers to wear long pants, a long-sleeved shirt, and chemical-resistant gloves. The levels of

protection that formed the basis for calculations of exposure from bensulide activities include:

• Baseline: Long-sleeved shirt and long pants, shoes and socks.

• Label: Long-sleeved shirt, long pants, shoes, socks, chemical resistent 

gloves.

• Minimum PPE: Baseline + chemical resistant gloves and a respirator.

• Maximum PPE: Baseline + coveralls, chemical resistant gloves, and a respirator.

• Engineering controls: Engineering controls such as a closed cab tractor or closed loading

system for granulars or liquids. Engineering controls are not applicable

to handheld application methods; there are no known devices that can

be used to routinely lower the exposures for these methods.

 For handlers, both short-term and intermediate-term assessments were conducted for

bensulide, to reflect exposures of either 1-7 days, or one week to several month durations, respectively. 

For bensulide, which is applied as a preemergent or preplant herbicide no more than twice a year, shortterm exposures are typically associated with private or individual growers or turf management

professionals who treat their own fields or turf sites. Intermediate-term exposures would be more

representative of commercial agricultural applicators, or “for hire” turf applicators, who would have

multiple exposures through treatment of agricultural or turf areas over the course of seven days or more. 

MOEs for all short and intermediate-term scenarios may be found in the June 16, 1999 Human Health

Assessment for Bensulide.

For the residential handler risk assessment, all application of bensulide by homeowners to turf is

considered to be short-term, and assumes that no protective clothing is used. A recently submitted turf

transferable residue (TTR) study was used in the residential assessment, to better define the amount of

residues on bensulide-treated turf. All residential MOEs are discussed in the Human Health Assessment

for bensulide. 
19

Finally, exposure to workers through entry into agricultural fields treated with bensulide, and

post-application exposure to homeowners entering or playing on lawns treated with bensulide were also

considered. 

c. Occupational & Residential Handler Risk Summary

In the revised assessment, risks for handlers were assessed using separate toxicological

endpoints for both dermal and inhalation exposures. The resulting risks (MOE values) were then added

in order to obtain an overall risk for each applicator that accounted for both dermal and inhalation

exposures. Additionally, where it was logical, the risks associated with certain job functions were

combined (e.g., a grower mixing/loading and then applying a spray solution to their own crops). Dermal

and inhalation risks are mitigated using different types of protective equipment, so it may be acceptable

to add a pair of gloves and not a respirator, and vice versa. All of the risk calculations for handlers

completed in this assessment are included in Appendix A of the HED chapter, dated June 16, 1999. 

For agricultural uses of bensulide, three different exposure scenarios were assessed. For

occupational uses on turf and ornamentals, 10 exposure scenarios were assessed. Residential use by

homeowners accounted for the remaining 2 exposure scenarios. Within each of the scenarios, further

analyses were conducted to determine the MOE at minimum and maximum application rates, and at

maximum and typical acreage, where applicable. Each of these analyses is included in Appendix A,

Tables 1-10 of the HED chapter. Tables 1 through 6 of Appendix A in the HED chapter illustrate how

the calculations were performed to define the MOEs for handlers in this risk assessment. Tables 7 and 8

provide summaries of the MOE values calculated for each route of exposure, dermal and inhalation,

respectively, in the risk assessment. Tables 9 and 10 provide the information that is key to interpreting

the overall results of the risk assessment because they contain the overall risks calculated using several

combinations of personal protection. The reader is referred to these tables for more information on this

comprehensive assessment. 

The following tables summarize the risk concerns after all assessments were revised using the

most current data and assumptions for occupational handlers, based on combined dermal and inhalation

exposures. The tables presented in this summary document outline the risks that remain of concern at

baseline (i.e., those scenarios that have MOEs < 100), and provides the risk estimates for each of these

scenarios at the existing label requirements, with PPE, and with engineering controls, to show the level to

which these risks can be mitigated. Note that the scenarios that are not of concern at baseline (i.e.,

MOEs > 100) are not reported in this document, but may be found in the comprehensive worker risk

tables in Appendix A of the HED chapter.

1) Agricultural Handler Risk

As stated above, the exposure scenarios with risks of concern at baseline are reported below,

along with the risks for each of these scenarios at the current label, with PPE, and/or with engineering
20

controls. The risk summary presented in this document focuses only on the scenarios that remain of

concern after all revisions to the assessment were made. Again, the scenarios that were not of concern

once all refinements were made are not reported here, but can be found in the comprehensive worker

risk tables in Appendix A of the HED chapter. The scenario numbers listed below correspond to

scenario numbers detailed and discussed in Appendix A of the HED chapter. For the agricultural uses

of bensulide, eight combinations of differing rates, acreages, and application methods for short-term and

intermediate-term exposures were assessed; of these, 2 have remaining risk concerns for short-term and

intermediate-term exposures, and one, applying sprays with a groundboom sprayer, has a risk concern

for intermediate-term exposure only. All MOEs in the tables below are based on combined dermal and

inhalation risks. The scenarios with remaining risk concerns at baseline are:

(1a) mixing/loading (M/L) liquids for chemigation application (350 acres, 40 acres);

(1b) M/L liquids for groundboom application (80 acres);

(3) applying sprays with a groundboom sprayer (80 acres).

 It should be noted that intermediate-term inhalation exposures are the main risk drivers for all

scenarios. One scenario, mixing/loading liquids for chemigation on 350 acres, at the maximum rate of 6

lbs ai/acre, is of concern for dermal exposure. (See Appendix A/Table 7).

As previously explained, bensulide is used on agricultural sites as a pre-emergent/pre-plant

herbicide. Some applicators, particularly growers who treat only their own fields, are more likely to

have short-term exposures – that is, exposures of seven days or less. Other applicators, especially

custom applicators who apply bensulide professionally to multiple fields, may be more likely to apply

bensulide over the course of 1 week or several weeks. These professional applicators may have

intermediate-term exposures that would result in risks of concern when using the personal protective

clothing specified on the label, and when the Agency’s standard assumption value of 350 acres treated/

day is used. 
21

Table 6. Agricultural Uses: Remaining Risk Concerns (combined dermal & inhalation MOEs)

Short-term MOE

Scenario Acres Rate Baseline1 Current

Label2

Current label +

respirator

Engineering Controls

(1a) M/L liquids for

chemigation 

350 3 1 98 138 356

350 6 <1 49 69 178

40 3 10 860 1210 3118

40 6 5 430 605 1559

(1b) M/L liquids for

groundboom appl.

80 3 5 430 605 1559

80 6 2.5 215 302 780

1

Long pants, long sleeve shirt, shoes, socks

2 Long sleeve shirt, long pants, shoes, socks, chemical resistant gloves 

Intermediate-term MOE

Scenario Acres Rate Baseline1 Current

Label2

Current label +

respirator

Engineering Controls

(1a) M/L liquids for

chemigation

350 3 1 23 95 197

350 6 <1 12 48 99

40 3 10 204 833 1726

40 6 5 102 417 863

(1b) M/L liquids for

groundboom appl.

80 3 5 102 417 863

80 6 2 51 208 432

(3) A/ sprays with

groundboom 

80 6 83 83 341 784

1

Long pants, long sleeve shirt, shoes, socks

2 Long sleeve shirt, long pants, shoes, socks, chemical resistant gloves 

2) Golf Course & Other Professional Turf Use Risk

As with the agricultural scenarios reported above, the turf exposure scenarios with risks of

concern at baseline, once all refinements were made, are reported below, along with the risk estimates

with increasing levels of protection. The turf scenarios that do not have risks of concern (i.e., MOEs >

100) are not reported here, but can be found in the comprehensive tables in Appendix A of the HED

chapter. The turf scenarios discussed in this section are for professional application to turf, including golf
22

course application, home-lawn application, and application to other turf sites, including recreational areas

and parks. Homeowners applying bensulide to lawns are discussed later in this document. The scenario

numbers listed below correspond to scenario numbers detailed and discussed in Appendix A of the

HED chapter. For these turf uses of bensulide, the Agency assessed 27 combinations of rates,

acreages, and application methods for short-term and intermediate-term exposures. Each combination

was assessed at baseline, existing label requirements, with PPE and with engineering controls. For shortterm exposures, 21 combinations had risks of concern at baseline once all refinements had been made;

for intermediate-term exposures, 21 combinations also had risks of concern for combined dermal and

inhalation exposure. Five more scenarios did not have sufficient data to assess the risks; the remaining

turf scenario -applying sprays with a groundboom sprayer at the low application rate- had acceptable

MOEs at baseline, and is therefore not reported in the table below. Different acreage values were

chosen to reflect different use patterns: 40 acres reflects treatment of an entire 18-hole golf course; 7

acres represents application to greens and tees only. A 5 acre value is used to represent a high-end

acreage value for home lawn application by a professional or “for hire” applicator, and 50 acres was

used to estimate professional handler risk (i.e., mixing/loading liquids) from exposure on other turf sites,

including parks and recreational areas.

 

The exposure scenarios included:

(1b) M/L liquids for groundboom application (40 acres);

(1c) M/L liquids for professional turf (50 acres)

(2) loading granulars for tractor-drawn spreader application (40 acres);

(5) Mixing/loading/applying (M/L/A) with a low pressure handwand (5 or 7 acres);

(6) M/L/A with a high pressure handwand (1000 gallons);

(7) M/L/A with a backpack sprayer (5 or 7 acres);

(8) M/L/A with a low pressure/high volume turfgun (5 or 7 acres);

(9) Loading and applying with a push-type granular spreader (5 acres);

(10) Loading and applying with a hand-held rotary spreader (5 acres). 

Most scenarios are of particular concern for intermediate-term inhalation exposure. High

exposure, handheld application methods pose both dermal and inhalation concerns, even with short-term

exposures. Exposure from these methods often cannot be mitigated with additional protective

equipment like a respirator; also, as noted in the table below, mitigation through the addition of

engineering controls is not feasible for these application methods. 

Bensulide is used on turf grass as a pre-emergent/pre-plant herbicide, and may be applied up to

two times/year for crabgrass and poa annua control. Some applicators, particularly those who treat

individual areas like single golf courses, may have short-term exposures of seven days or less. Other

applicators, like “for hire” applicators who apply bensulide professionally to multiple golf courses or

large turf areas, may be more likely to apply bensulide over a 1 week or several week period, and thus
23

need additional levels of personal protection beyond those required by an individual with short-term

exposures.

The risks of concern for golf course and other turf uses are summarized below: 

Table 7. Golf Course & Other Turf Uses: Remaining Risk Concerns (combined dermal &

inhalation MOEs)

Short-term MOEs

Scenario Acres Rate Baseline1 Current

label2

Current label +

respirator 

Engineering

controls

(1b) M/L liquids for

groundboom appl.

40 7.5 4 344 484 124782

40 12.5 2 206 291 748

(1c) M/L liquids for

professional turf appl.

50 7.5 3 275 387 998

50 12.5 2 165 232 599

(5) M/L/A w/low pressure

handwand

 5 7.5 <1 133 204 NF3

 5 12.5 <1 80 122 NF

 7 7.5 <1 95 146 NF

 7 12.5 <1 57 88 NF

(6) M/L/A w/high pressure

handwand

1000

gal.

 0.16 No data 6 8 NF

(7) M/L/A w/backpack

sprayer

 5 7.5 No data 34 37 NF

 5 12.5 No data 20 22 NF

 7 7.5 No data 24 26 NF

7 12.5 No data 14 16 NF

(8) M/L/A with low

pressure/high volume

turfgun

5 7.5 25 243 258 NF

5 12.5 15 146 154 NF

7 7.5 18 174 184 NF

7 12.5 11 104 110 NF
Short-term MOEs

Scenario Acres Rate Baseline1 Current

label2

Current label +

respirator 

Engineering

controls

24

(9) Loading and applying

w/push-type granular

spreader

5 7.5 32 70 73 NF

5 12.5 19 42 44 NF

(10) Loading and applying

with hand held rotary

spreader

5 7.5 9 10 15 NF

5 12.5 5 6 9 NF

1 Long-sleeve shirt, long pants, shoes, socks 

2 Long-sleeve shirt, long pants, shoes, socks, chemical resistent gloves

3 N/F = Not Feasible

Intermediate-term MOEs

Scenario Acres Rate Baseline1 Current

label2

Current label +

respirator

Engineering

controls

(1b) M/L liquids for

groundboom appl.

40 7.5 4 82 333 690

40 12.5 2 49 200 414

(1c) M/L liquids for

professional turf appl.

50 7.5 3 65 266 552

50 12.5 2 39 160 331

(2) L/ granulars for

tractor-drawn spreader

appl.

40 7.5 65 66 488 3270

40 12.5 39 40 293 1962

(3) A/sprays with

groundboom sprayer

40 12.5 80 80 327 753

(4) A/ granulars with

tractor-drawn spreader

40 7.5 90 92 607 484

40 12.5 54 55 365 290

(5) M/L/A with low

pressure handwand

 5 7.5 <1 27 128 NF3

 5 12.5 <1 16 77 NF

 7 7.5 <1 19 91 NF

7 12.5 <1 12 55 NF

(6) M/L/A with high

pressure handwand

1000 gal 0.16 No data 2 6 NF
Intermediate-term MOEs

Scenario Acres Rate Baseline1 Current

label2

Current label +

respirator

Engineering

controls

25

(7) Backpack sprayer 5 7.5 No data 17 33 NF

5 12.5 No data 10 20 NF

7 7.5 No data 12 24 NF

7 12.5 No data 7 14 NF

(8) Low pressure/high

volume turfgun

5 7.5 24 150 242 NF

5 12.5 14 90 145 NF

7 7.5 17 108 173 NF

7 12.5 10 64 104 NF

(9) Loading and applying

with push-type granular

spreader

5 7.5 26 49 70* NF

5 12.5 16 30 42* NF

(10) Loading and applying

with hand-held rotary

spreader

5 7.5 6 6 9 NF

5 12.5 4 4 6 NF

1

 Long-sleeve shirt, long pants, shoes, socks 

2 Long-sleeve shirt, long pants, shoes, socks, chemical resistant gloves

3 N/F = Not Feasible

* For these scenarios, MOEs of 122 and 73, respectively, can be achieved with a double layer of clothing, chemical

resistent gloves, and a respirator. 

3) Post-Application Occupational Risk

The post-application occupational risk assessment considered exposures to workers entering

treated sites in agriculture as well as exposures that can occur as a result of turf management activities.

All of the post-application risk calculations for handlers completed in this assessment are included in

Appendix B of the HED chapter.

For agricultural uses, the Agency does not consider post-application exposure problematic due

to the cultivation practices that are anticipated with the pre-plant/pre-emergence use of bensulide on the

labeled agricultural crops. Therefore, the Agency has determined that the current label requirement of

12 hours is adequate.

In making this determination, the Agency has considered all available use information and current

labeling. It does have some reservations, however, with regard to workers in transplanting operations. 

The United States Department of Agriculture (USDA) has indicated that, in most transplanting
26

operations, mechanical planters are used to place transplants in the soil and therefore workers are not

exposed to bensulide. EPA agrees that workers are not likely to be exposed to soil directly through

transplanting, but may contact bensulide through exposure to soil remaining on the transplant wheel. To

better define this exposure, EPA is requesting information on this cultural practice in a Data Call-In that

is being issued along with this Interim RED.

For turf uses, there is potential for post-application exposure to workers performing turf

management activities (golf course greens keepers and landscaping personnel). Risk estimates were

calculated using actual measured values derived from the turf transferable residue study, which accounts

for watering-in of bensulide. Watering-in is required by labels for efficacy of the herbicide. 

Following the watering-in of bensulide, MOEs are greater than 100 (i.e., not of concern) on the

day of application, even when professionals are conducting high exposure activities (e.g., heavy

weeding) following the highest application rate (MOE = 480). Even if the watering-in was not as

extensive as the 0.5 inches achieved in the study (i.e., using the pre-watering in data), MOEs are still

greater than 100 on the day of application, even when professionals are conducting high exposure

activities following the highest application rate. Therefore, post-application risk from bensulide use on

turf is not of concern.

4) Residential (Homeowner) Handler Risk

For homeowner handler exposure assessments, the Agency does not believe a tiered mitigation

approach like that used for assessing occupational handler risk is appropriate. Homeowners often lack

access to personal protective equipment (PPE) and also do not possess expertise in the proper use of

PPE. As a result, homeowner handler assessments are completed using a single scenario based on the

use of short-sleeved shirts and short pants (i.e., common homeowner attire during the pesticide

application season). In addition, only short-term exposures were assessed, as the Agency does not

believe homeowners who apply bensulide will be exposed to bensulide for more than 7 days. The

exposure scenarios included:

(9) M/L/A with push-type granular spreader (0.5 acres);

(10) M/L/A with hand-held rotary spreader (0.5 acres).

The labels for homeowner products allow homeowners to use a push-type granular spreader or

a hand-held rotary spreader (e.g., bellygrinder) to mix, load, and apply bensulide, and allow use rates of

up to 12.5 lbs a.i. per application, which is recommended for heavy weed pressure. The labels also

instruct homeowner handlers to “sprinkle the area with water for 10-15 minutes after application.....”

Risk estimates indicate that, when short-term dermal and inhalation exposures are combined, the

Agency has no concerns for homeowners who load and apply bensulide with a push-type granular

spreader. MOEs for this scenario are 305 and 183 for the low and high-use rate, respectively.
27

However, the Agency has concerns for homeowners who load and apply bensulide with a hand-held

rotary spreader (e.g., bellygrinder). Combined short-term dermal and inhalation exposures result in

MOEs of less than 10. Risks for homeowner handlers using a hand-held rotary spreader are in the table

below. 

Table 8. Homeowner Uses: Risk Concerns (combined dermal & inhalation MOEs)1

Scenario Acres Rate Short-Term MOE

(10) L/A with hand-held rotary

method

0.5 7.5 8

0.5 12.5 5

1 Shorts, short-sleeved shirt.

5) Residential Post-Application Risk

Bensulide can be used on home lawns, golf courses, and on other turf areas where exposure to

adults and children may occur. Exposure may result from entering the area, performing yard work,

playing or performing other recreational activities (e.g., golfing) on the treated areas. As a result, both

toddler and adult risks were considered in the risk assessment.

Risks were calculated using actual measured values derived from a bensulide-specific turf

transferable residue (TTR) study, which accounts for watering-in of bensulide in a controlled setting and

use of 0.5 inches of water to thoroughly water in the granules. Post-application risks for adults in

residential settings were calculated for individuals involved in light exposure activities such as golfing and

also in heavy exposure activities such as heavy yard work.

Using the results of the TTR study, MOEs for adults were calculated to be greater than 100 on

the day of application (MOE = 480) even when completing high exposure activities following the highest

application rates. If the watering in was not as extensive as the 0.5 inches achieved in the study, MOEs

are still greater than 100 on the day of application (MOE = 150) even when people are conducting high

exposure activities following the highest application rate. Therefore, the Agency is not concerned about

post-application exposure for residential adults, including golfers.

Post-application risks for toddlers in a residential setting were calculated for individuals involved

in heavy exposure activities (e.g., hard play), and at the minimum and maximum application rates for

bensulide using the bensulide TTR study. Also, risks from non-dietary ingestion (e.g., a child grabbing a

handful of turf and mouthing it, or a child putting dirty hands in its mouth) of bensulide were calculated.

Following the watering-in of bensulide, the MOEs for dermal exposures were greater than 100

on the day of application at the highest application rate for toddlers in high exposure activities (e.g., hard

play) over a long duration. If bensulide was used at the highest labeled application rate, and if the

watering in was not as extensive (i.e., less than 0.5 inches), the MOE for dermal exposure is 74 and
28

therefore of concern to the Agency. The risks associated with non-dietary ingestion are not of concern

to the Agency. Both prior to and following watering in of bensulide, MOEs for non-dietary ingestion are

well above 100, based on guidance from the Agency’s current standard operating procedures (SOPs)

for residential exposure assessment. It should be noted here that the Agency’s SOPs for residential

exposure assessment will be updated sometime this year; once this occurs, it is expected that the risks

will decrease even further using the new methodology.

4. Aggregate Risk

An aggregate risk assessment looks at the combined risk from dietary exposure (food and

drinking water routes) and residential exposure (dermal exposure, inhalation exposure for homeowner

applicators, and incidental oral exposure for toddlers who mouth grass). Aggregate exposure risk

assessments for bensulide were conducted for acute (1-day), short-term (1-7 days), and chronic

(lifetime) exposure. Generally, all risks from these exposures must have MOEs of greater than 100 to

be not of concern to the Agency. Results of the aggregate risk assessment are summarized here, and are

discussed extensively in the June 16, 1999 HED chapter, as well as in the February 11, 2000 addendum

to the HED chapter. 

 Acute aggregate exposure, by definition, consists only of food and drinking water exposure. 

Chronic aggregate exposure consists only of food and drinking water, because there is no chronic

residential exposure to bensulide. Risk estimates indicate that acute aggregate exposure to bensulide is

not of concern. Similarly, chronic aggregate exposure is not of concern (see drinking water discussion in

Section III. B. 2. (c) of this document). 

Short-term aggregate exposure to bensulide consists of food, residential exposure (dermal,

inhalation, and non-dietary oral), and drinking water. Short-term aggregate exposure is not of concern

when bensulide is watered-in thoroughly and consistently, provided that a homeowner uses a push-type

drop spreader, rather than a hand-held rotary applicator. 

A summary of the short-term aggregate exposures is shown in Table 9 below. The first column,

“Total MOE for Non-Water Exposures,” includes the combined risk estimates from food (the % PAD

has been converted to an MOE so that food and residential exposures could be added together;

methodology for this conversion is found in the HED chapter) and residential exposures for each

population. As shown, the combined food and residential MOEs are not of concern; that is, MOEs are

>100 for all populations. For drinking water, the environmental concentrations for either ground or

surface water are significantly below the DWLOC, which is the maximum allowable concentration that

will not exceed the Agency’s level of concern. Therefore, even when drinking water is added to the

food and residential exposures, the short-term aggregate exposure is not of concern.
29

Table 9. Drinking Water Levels of Comparison for Short-term Aggregate Exposure

Population

Total MOE

for NonWater

Exposures

Ground Water

(ppb)1

(SCI-GROW)

Surface Water

ppb)2, 4

(GENEEC)

Surface Water

(ppb)3

(PRZM-EXAMS)

DWLOC

(ppb)

Homeowners Who Apply

(General Pop. Handlers) 183 0.5/1.0 19/34 158 2,388

Yard work (General Pop.,

Heavy Activity) 482 0.5/1.0 19/34 158 4,160

Golfers (General Pop.,

Light Activity) 8,257 0.5/1.0 19/34 158 5,186

Toddlers 236 05/1.0 19/34 158 863

1

The value of 0.5 ppb is with 1 turf application/year, the 1.0 ppb value is with 2 turf applications/year.

2

The value of 19 ppb is with 1 turf application/year, 34 ppb is with 2 turf applications/year

3

The value of 158 ppb is with broadcast vegetable application.

4 GENEEC values have been adjusted per SOP 99-5 to obtain a long-term average estimate. This SOP is cited and

discussed in more detail in the February 11, 2000 addendum to the HED chapter available in the public docket.

B. Environmental Risk Assessment

A summary of the Agency’s environmental risk assessment is presented below. For detailed

discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects

Division chapter, dated 6/14/99, available in the public docket. Since this document was completed, the

Agency made changes in its approach to estimating environmental concentrations (ECs) for turf uses.

This change, and the resulting risk quotients (RQs) are discussed fully in the 2/17/00 document entitled,

“Addendum to the Bensulide RED: Revised Risk Assessment and Risk Characterization for Risk to

Aquatic Organisms from Use on Turf.” 

Several revisions have been made since the preliminary risk assessment was completed, and

include:

- Use of data from a turf residue study to assess exposure to terrestrial wildlife.

- Use of aquatic toxicity data to characterize risk to aquatic species. 

- Use of GENEEC instead of PRZM-EXAMS to estimate environmental concentrations from

the turf uses, for use in drinking water and ecological assessments. 
30

1. Environmental Fate and Transport

 Although the environmental fate data base for bensulide is not complete, information from

acceptable laboratory studies indicates bensulide is persistent. Neither abiotic hydrolysis nor photolysis

are major degradation processes in water or on soil surfaces. The main route of dissipation of bensulide

appears to be aerobic soil metabolism with a reported half-life of 1 year, based on laboratory studies.

Under aerobic conditions, it appears that mineralization of bensulide to carbon dioxide and

immobilization as unextractable residues are the major mechanisms of dissipation in the soil. Under

anaerobic soil conditions, bensulide did not degrade. Based on the lack of degradation under laboratory

conditions, it is predicted that bensulide will be extremely persistent in anaerobic terrestrial ecosystems. 

Information from acceptable laboratory studies indicates that bensulide is not mobile in the four

soils tested (Kocs ranged from 1,433 to 4,326 ml/g); however, the degradates bensulide oxon ( N-[(2-

(diisopropoxyphosphinoylthio)-1-ethyl]- benzenesulfonamide) and benzenesulphonamide ranged from

mobile to highly mobile in the same four test soils. Bensulide has the potential to be transported both

dissolved in water and on suspended sediment in runoff to surface waters where, based on laboratory

data, it is expected to persist. Bensulide has the persistence characteristics of chemicals found capable

of leaching to ground water; however, based on other environmental fate characteristics (i.e., high

sorption capacity) and supporting groundwater modeling, bensulide is not expected to leach to ground

water. 

The environmental fate assessment developed from the results of the laboratory studies has not

been confirmed by acceptable field dissipation information. In eight unacceptable field dissipation

studies reportedly using bensulide at 6 and 12.5 lb ai/A, the half-life of bensulide was reported to range

from 8-34 days in studies conducted in California, and from 91-210 days in studies conducted in

Mississippi. However, in none of the studies was a consistent decline of parent compound observed. 

None of the studies are acceptable, because the application rate could not be confirmed and bare

ground plots were not used for confirmation of application. The study plots had been planted to turf,

and no mention was made of how the turf and thatch in the samples were separated from the soil or of

any attempt to extract residues from the turf or thatch. The registrant is currently conducting a new field

dissipation study that will be completed by mid-2000. Preliminary review of interim data from that study

have confirmed the Agency’s fate assessment of bensulide.

2. Risk to Birds and Mammals

The most significant risk from bensulide use is chronic avian risk due to eggshell thinning. 

Eggshell thinning caused by bensulide in laboratory studies is similar to the effects of the organochlorines

DDT and DDE, but with approximately 10 times less potency; that is, 10 times greater concentration of

bensulide is necessary to produce an effect equal in magnitude. Chronic risk from bensulide approaches

that of DDT because bensulide is used at such high rates (two applications of up to 12.5 lbs ai/acre each

on turf sites). This risk is of greater concern on large turf areas, where water fowl are attracted and
31

where they tend to feed and forage. These risks are increased by bensulide’s persistence in soil (greater

than 200 day soil half-life) and multiple applications.

Gowan Company, the registrant for bensulide, submitted data on residues on grass to aid the

Agency in its assessment of dietary exposure to terrestrial wildlife. These data were collected in

conjunction with a total turf residue study used in the human health assessment. (For more details on this

study, refer to the EFED chapter, Addendum 2). The study shows the amount of the bensulide residues

on grass that would be removed by irrigation, which is required within 36 hours after application. The

Agency is able to conclude that irrigation will remove approximately one-third of the initial residues on

short grass foliage, which means a reduction in exposure to birds and mammals. However, when the

risk assessment was updated to reflect the new data, results still indicate that the turf uses pose a high

risk of causing reproductive impairment in birds. The Agency has calculated risk quotients for birds;

these are presented and discussed fully in the 6/14/99 EFED chapter.

Bensulide also poses chronic risk to mammals through residues on wildlife food items (if sprayed

directly), risks that are increased by the stability and persistence of bensulide in the environment. The

high persistence of bensulide also increases the opportunity for routes of avian and mammalian exposure

other than in the diet. The Agency is particularly concerned with exposures from the large turf uses

(primarily from golf course use). There is currently no acceptable field dissipation study for bensulide. 

However, Agency review of an interim report of an ongoing field dissipation study conducted by the

registrant confirms bensulide’s fate properties, particularly its persistence.

3. Risk to Aquatic Species

 Most turf uses pose some risk to aquatic species. The Agency has recently updated its risk

characterization for risk to aquatic organisms from turf use in a 2/17/00 memo entitled, “Addendum to

the Bensulide RED: Revised Risk Assessment and Risk Characterization for Risk to Aquatic Organisms

from Use on Turf.” This update was conducted to reflect a change in the model used to estimate the

environmental concentrations of bensulide, and results indicate a reduction in the overall level of risk

predicted for aquatic organisms, although some high risks still exist. The memo also discusses the impact

of the risk mitigation currently being proposed for use on golf course fairways; that is, the reduction in

the total number of applications from 2 times/year to 1 time/year.

In general, the acute levels of concern for bensulide are exceeded for freshwater fish, including

those for threatened or endangered species and for freshwater invertebrates. For estuarine and marine

fish and nonendangered aquatic plants, turf poses a high acute risk at two applications per year;

restricting the use to one application per year mitigates the high acute risk. Also, high acute risk to

estuarine and marine invertebrates exists. Bensulide poses low chronic risk to freshwater fish, and high

chronic risk to freshwater invertebrates. 
32

Agricultural uses pose less risk because the use is generally in drier areas of the country where

surface run-off is less likely, and use rates are lower (3 to 6 lbs ai/acre).

IV. INTERIM RISK MANAGEMENT AND REREGISTRATION DECISION

A. Determination of Interim Reregistration Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant

data concerning an active ingredient, whether products containing the active ingredient is eligible for

reregistration. The Agency has previously identified and required the submission of the generic (i.e., an

active ingredient specific) data required to support reregistration of products containing bensulide active

ingredients. 

The Agency has completed its assessment of the occupational and ecological risks associated

with the use of pesticides containing the active ingredient bensulide, as well as a bensulide-specific

dietary risk assessment that has not considered the cumulative effects of organophosphates as a class. 

Based on a review of these data and public comments on the Agency’s assessments for the active

ingredient bensulide, EPA has sufficient information on the human health and ecological effects of

bensulide to make an interim determination of reregistration eligibility and to make some interim decisions

as part of the tolerance reassessment process under FQPA. Although the Agency has not yet

completed its cumulative risk assessment for the organophosphates, the Agency is issuing this interim

assessment now in order to identify risk reduction measures that are necessary to allow the continued

use of bensulide. Appendix B identifies the generic data requirements that the Agency reviewed as part

of its determination of interim reregistration eligibility of bensulide, and lists the submitted studies that the

Agency found acceptable.

As a result of its assessment of the remaining risks of bensulide alone, EPA has determined that

certain uses of bensulide, unless amended as set forth in this document, present risks inconsistent with

FIFRA. Accordingly, EPA may commence a full risk/benefit analysis, the outcome of which may

indicate that cancellation proceedings are warranted, unless registrants agree to label changes

implementing the risk reduction measures discussed in this reregistration eligibility decision. At the time

that a cumulative assessment is conducted, the Agency will address any outstanding risk concerns. For

bensulide, if all changes outlined in this document are incorporated into the labels, then all risks will be

mitigated and no outstanding risk concerns for this individual chemical will remain. But, because this is

an Interim RED, the Agency may take further actions, if warranted, to finalize the reregistration eligibility

decision for bensulide after assessing the cumulative risk of the organophosphate class. Such an

incremental approach to the reregistration process is consistent with the Agency’s goal of improving the

transparency of the reregistration and tolerance reassessment processes. By evaluating each

organophosphate in turn and identifying appropriate risk reduction measures, the Agency is addressing

the risks from the organophosphates in as timely a manner as possible. 
33

Because the Agency has not yet completed the cumulative risk assessment for the

organophosphates, this reregistration eligibility decision does not fully satisfy the reassessment of the

existing bensulide food residue tolerances as called for by the Food Quality Protection Act (FQPA).

When the Agency has completed the cumulative assessment, bensulide tolerances will be reassessed in

that light. At that time, the Agency will reassess bensulide along with the other organophosphate

pesticides to complete the FQPA requirements and make a final reregistration determination. By

publishing this reregistration eligibility decision and requiring risk mitigation now for the individual

chemical bensulide, the Agency is not deferring or postponing FQPA requirements; rather, EPA is taking

steps to assure that uses which exceed FIFRA’s unreasonable risk standard do not remain on the label

indefinitely, pending completion of assessment required under the FQPA. This decision does not

preclude the Agency from making further FQPA determinations and tolerance-related rulemakings that

may be required on this pesticide or any other in the future. 

If the Agency determines, before finalization of the RED, that any of the determinations

described in this Interim RED are no longer appropriate, the Agency will pursue appropriate action,

including but not limited to, reconsideration of any portion of this Interim RED.

B. Summary of Phase 5 Comments and Responses

When making its interim reregistration decision, the Agency took into account all comments

received during Phase 5 of the OP Pilot Process. As stated previously, a mitigation proposal was

received from Gowan Company; details of this proposal are discussed in the next section. Several other

comments on mitigation were also received from 1.) an agricultural extension agent in the southwestern

United States; 2.) Natural Resources Defense Council (NRDC); 3.) the Golf Course Superintendents

Association of America (GCSAA); and 4.) members of the golf course industry. These comments in

their entirety are available in the docket. A brief summary of the comments and the Agency response is

noted here.

1.) Comment. A weed scientist/agricultural extension agent from the University of California, Imperial

County, commented that he would like the current agricultural use pattern of bensulide to continue. He

also supplied use and usage-type information for minor use crops grown in the Imperial Valley.

Response. This comment provided no specific mitigation suggestions. It did, however, provide valuable

use and usage data, some of which had already been used to update the risk assessments.

2.) Comment. The National Resources Defense Council provided general comments on the

organophosphates, and specific comments on bensulide. With regard to bensulide-specific comments on

mitigation, NRDC recommends removing the residential uses, because of a special concern for toddlers. 
34

Response. With regard to bensulide-specific mitigation, NRDC commented only on the residential risk

to children. The Agency has reviewed NRDC’s suggestion that the residential use of bensulide be

removed, especially because of risk to toddlers. The Agency notes that the risk for both adults and

toddlers are not of concern if label directions are followed; therefore, there is no risk basis for removing

this use from the label. However, the Agency is requiring that the directions for use on the current

language be clarified and expanded, to ensure that bensulide is used properly and safely. 

3.) Comment. The Golf Course Superintendents Association of America commented that restricting the

use of bensulide to greens and tees, as well as making the chemical Restricted Use, would not pose a

burden on the golf industry. GCSAA did indicate, however, that reducing rates would severely reduce

the efficacy of bensulide and therefore render it unsuitable for use on golf courses. 

4.) Comment. Two golf course superintendents in Dublin, Ohio wrote that bensulide is needed for

bentgrass greens, tees, and fairways.

Response to Comments 3 and 4. The Agency reviewed these comments, and determined that the use

on greens and tees could remain unchanged from current practices. The use on fairways will be

restricted to certain states and to one grass type, to satisfy the niche use of this chemical. The fairway

use will be restricted, however, from two applications per year to one application per year in the fall, to

partially alleviate the Agency’s ecological concerns with regard to avian risk. Requiring that bensulide be

a restricted use chemical was determined to be unnecessary at this time. 

C. Regulatory Position

1. FQPA Assessment

a. “Risk Cup” Determination

As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with

this organophosphate. The assessment was for this individual organophosphate, and does not attempt to

fully reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food

tolerances on the basis of cumulative risk from substances sharing a common mechanism of toxicity, such

as the toxicity expressed by the organophosphates through a common biochemical interaction with the

cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the entire class of

organophosphates once the methodology is developed and the policy concerning cumulative

assessments is resolved. 

EPA has determined that risk from exposure to bensulide is within its own “risk cup.” In other

words, if bensulide did not share a common mechanism of toxicity with other chemicals, EPA would be

able to conclude today that the tolerances for bensulide meet the FQPA safety standards. In reaching

this determination EPA has considered the available information on the special sensitivity of infants and
35

children, as well as the chronic and acute food exposure. An aggregate assessment was conducted for

exposures through food, residential uses, and drinking water. Results of this aggregate assessment

indicate that the human health risks from these combined exposures are considered to be within

acceptable levels; that is, combined risks from all exposures to bensulide “fit” within the individual risk

cup. Therefore, the bensulide tolerances remain in effect and unchanged until a full reassessment of the

cumulative risk from all organophosphates is completed. 

b. Tolerance Summary

In the individual assessment, tolerances for residues of bensulide in/on plant commodities [40

CFR §180.241] are presently expressed in terms of the combined residues of bensulide and its oxygen

analog. Following evaluation of plant metabolism studies, the Agency has determined that the bensulide

residues that warrant regulation in plant commodities are those that are currently regulated. 

Adequate data are available to reassess the established tolerances for the following commodities: 

cucurbits, carrots, leafy vegetables, peppers and onions (dry bulb). EPA recommends that tolerances for

cucurbits, and leafy vegetables be revised from 0.1 ppm to 0.15 ppm to account for the instability of

bensulide per se in/on these commodities as evidenced in a nonconcurrent storage stability study. In

addition, the established tolerance for carrots must be revised to a tolerance with regional registration. 

The established tolerance for cottonseed should be revoked because there are currently no registered

uses of bensulide on cotton.

A tolerance must be proposed for the Brassica (cole) vegetables group; the Agency

recommends the registrant propose a tolerance of 0.15 ppm. Also, some minor modifications to the

tolerance expression must be made. A bensulide tolerance summary is presented below and in Table 5

of the HED chapter. 

 Table 10. Tolerance Summary for Bensulide.

Commodity Current Tolerance,

ppm

Tolerance

Reassessment*, ppm1

Comment/

[Correct Commodity Definition]

Tolerances Listed Under 40 CFR §180.241

Carrots 0.10 0.10

This tolerance must be modified to

one with regional registration (TX). 

Also, labels must be amended to

reflect a maximum seasonal use rate

of 5 lb/A. 

Cottonseed 0.10 Revoke There are currently no registered

uses of bensulide on cotton.

Cucurbits 0.10 0.15 [Cucurbit Vegetables Group]
Commodity Current Tolerance,

ppm

Tolerance

Reassessment*, ppm1

Comment/

[Correct Commodity Definition]

36

Fruiting Vegetables30.10 0.10 [Fruiting Vegetables (except

cucurbits) Group]

Leafy vegetables 0.10 0.15 [Leafy Vegetables (except

Brassica Vegetables) Group]

Onions (dry bulb) 0.10 0.10

Tolerance to be Proposed

Brassica (Cole) Leafy

Vegetables Group -- 0.152

[Brassica (Cole) Leafy

Vegetables]

1

 Existing tolerances have been reassessed in light of the submitted 3-year storage stability study for bensulide and

bensulide oxon.

2

 The registrant should propose a tolerance of 0.15 ppm for Brassica (Cole) Leafy Vegetables.

3

 Labels must be amended to restrict use to bell peppers only, unless three non-bell pepper field trials are conducted. 

* The term “reassessed” here is not meant to imply that the tolerance has been reassessed as required by FQPA,

since this tolerance may be reassessed only upon completion of the cumulative risk assessment of all

organophosphates, as required by this law. Rather, it provides a tolerance level for this single chemical, if no

cumulative assessment was required, that is supported by all of the submitted residue data. 

The Agency will commence proceedings to revoke the tolerance for cotton, and to modify the

existing tolerance for carrots to a tolerance with a regional registration in Texas, as defined in § 180.1(n). 

Amendment of the commodity designations to reflect the correct commodity definitions will also be

undertaken now. The establishment of a new tolerance for the group “brassica (cole) leafy vegetables”

will be deferred, pending the outcome of the cumulative assessment. 

2. Endocrine Disruptor Effects

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to

determine whether certain substances (including all pesticide active and other ingredients) "may have an

effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such

endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine

Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was

scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in

addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommendation that the

Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use

FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an

effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and

resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor

Screening Program (EDSP).
37

When the appropriate screening and/or testing protocols being considered under the Agency’s

EDSP have been developed, bensulide may be subjected to additional screening and/or testing to better

characterize effects related to endocrine disruption.

3. Required Label Modifications

The Agency is requiring that the bensulide registration be amended to mitigate risk to 1.)

handlers from use on agricultural sites, 2.) professional handlers and homeowners handlers from use on

turf sites, and 3.) nontarget organisms, primarily from use on turf. The Agency has determined that

these measures, in addition to the existing label requirements, will reduce risks to workers, and

homeowners to an acceptable level, and that unreasonable adverse effects are unlikely to result from

such use. With regard to post-application risk to children, the Agency is requiring clarification and

strengthening of the existing label language to ensure that no risk will occur from improper use. 

Regarding ecological risks, the registrant has not agreed to modification of its labels to fully mitigate these

risks; this issue will be discussed in the appropriate section below. Provided the following risk mitigation

measures are incorporated in their entirety into labels for bensulide-containing products, the Agency

finds that all currently registered uses of bensulide are eligible for interim reregistration, pending a

cumulative assessment of the organophosphates. The regulatory rationale for each of the mitigation

measures outlined below is discussed immediately after this list of required mitigation measures. 

a. Agricultural and Turf Uses: Occupational and Ecological Risk

Mitigation

For agricultural use, the following measures are required, in addition to the existing

label requirements (long-sleeve shirt, long pants, shoes, socks, chemical resistent gloves):

– Require respirators for mixing/loading liquids for chemigation; mixing/loading liquids for

groundboom applications.

– Require respirators or closed cabs for commercial applicators applying sprays with a

groundboom sprayer.

– Limit chemigation use to California and Arizona.

For golf course and home lawn use, the following measures are required, in addition to

the existing label requirements (long-sleeve shirt, long pants, shoes, socks, chemical resistent

gloves):

– Require respirators for mixing/loading liquids; loading granulars for tractor drawn

spreader; applying granulars with tractor drawn spreader.

S Require respirators for commercialor “for hire” applicators applying sprays with a

groundboom sprayer and for commercial or “for hire” applicators applying liquids with a

low pressure/high volume turf gun.
38

– Require respirators and coveralls for application with a push-type granular spreader.

– Prohibit use of a high pressure handwand, backpack sprayer and handheld rotary

application methods. 

– Restrict the use of a low pressure handwand to spot treatments only.

– Restrict the use on fairways to one application during the fall season.

– Restrict the use on fairways to only 18 states (OH, PA, NY, MI, CT, MA, IN, IL, NJ,

WV, MN, WI, VT, NH, RI, DE, MD, and VA) and, in these states, to only bentgrass

fairways.

– Prohibit use on ornamentals, parks and recreational areas on all labels.

b. Homeowner Use: Homeowner and Ecological Risk Mitigation

The following measures are required: 

– Add a label statement prohibiting granular application with any handheld rotary methods

(e.g., prohibit bellygrinder). 

– Add a label statement in red print in front of homeowner product labels that states:

“THIS PRODUCT WILL NOT WORK IF NOT WATERED IN FOR 10-15

MINUTES. FOR SAFETY REASONS, WATER THIS PRODUCT IN AS SOON

AS POSSIBLE FOLLOWING APPLICATION FOR 10-15 MINUTES AND DO

NOT ALLOW CHILDREN OR PETS ON TREATED AREAS UNTIL DRY.”

 – Prohibit use on ornamentals, parks and recreational areas.

D. Regulatory Rationale

The following is a summary of the rationale for managing risks associated with the use of

bensulide. Where labeling revisions are imposed, specific language is set forth in the summary tables of

Section V of this document.

1. Human Health Risk Mitigation

a. Dietary Mitigation

1) Acute Dietary (Food)

Acute dietary risk from food is well below the Agency’s level of concern – a Tier 1 DEEMTM

analysis yielded percent acute PAD values that are less than 1% at the 95th percentile of exposure for

the most exposed subgroups (children 1-6 years old, and infants <1 year old). Therefore, no mitigation

measures are necessary at this time to address acute dietary risk from food.
39

2) Chronic Dietary (Food)

Chronic dietary risk from food is also below the Agency’s level of concern – percent chronic

PAD values are less than 1% for the most exposed population subgroups. Therefore, no mitigation

measures are necessary at this time to address chronic dietary risk from food.

3) Drinking Water

As explained earlier in this document, most modeled estimates of potential drinking water

exposure from both ground and surface water sources (i.e., EECs) do not exceed the acute or chronic

DWLOC values, and therefore would not be of concern to the Agency. One scenario, chronic

exposure from the agricultural uses of bensulide through surface water, exceeds the DWLOCs

somewhat for non-nursing infants. However, this estimate is considered to be an overestimate in that it

does not accurately represent what may be found in drinking water. No mitigation is necessary at this

time. 

b. Occupational Risk Mitigation

1) Agricultural Uses

To address risks from inhalation exposure for the agricultural handler scenarios discussed in

Section III of this document and shown in Table 6 of that section, the following mitigation measures are

required, in addition to the existing label requirements:

– respirators for mixing/loading liquids for chemigation;

– respirators for mixing/loading liquids for groundboom applications; 

– either respirators or closed cabs for commercial applicators applying sprays with a

groundboom sprayer.

– restrict the use of chemigation to California and Arizona

The respirators or closed cabs mitigate all inhalation MOEs to greater than 100, which eliminates

this risk concern. Table 6 shows the MOEs that are achieved for each scenario when respirators or

closed cabs are considered in the assessment.

Risks remain from dermal exposure when mixing/loading liquids for chemigation on 350 acres

per day at the maximum rate of 6 lbs ai/acre (dermal MOE = 69 with a respirator). EPA recognizes that

this may be an overestimate, however, both with the surrogate data used in the assessment and with the

assumptions regarding acres treated. For example, the Agency’s assessment analyzed the handling of

210 2.5 gallon jugs of Prefar 4-E (bensulide liquid formulation) to treat 350 acres per day. Handling

multiple open jugs has far greater exposure potential than handling fewer bulk containers to treat the

same area. The registrant, Gowan Company, has submitted extensive comments rebutting EPA’s
40

standard assumptions for the chemigation use, and has indicated that the herbicide is transported and

distributed in bulk containers, not in the standard 2.5 gallon jugs. While EPA does not agree that these

bulk containers with a single coupling device constitute a closed system, as Gowan contends, the

Agency does agree that using multiple open-pour jugs may not accurately estimate the actual handler

exposure that can occur when using bulk containers. However, it does not have a study or any other

data to better characterize this exposure scenario.

Gowan has also indicated that all chemigation with bensulide occurs in the states of Arizona and

California. The registrant has successfully shown that the acreage treated with bensulide, for Arizona

and California, is much less than the Agency standard assumption of 350 acres. Gowan submitted use

data for 1996 to 1999 to the Crop Data Management System (CDMS), a voluntary use reporting

system that records, among other things, extensive information on acreage treated and application rates. 

Approximately 4500 bensulide applications are summarized. Based on CDMS data, the median area of

a chemigation application is 15 acres. The largest field treated was 190 acres, followed by one 170-

acre field, two 157-acre fields, and 29 150-acre fields. Of the almost 4500 applications, only 73 of

these involved areas of 100 acres or more. The maximum acreage permissible to achieve a dermal MOE

of 100 or greater, when the highest rate of 6 lbs./acre is used, is 200 acres.

The Agency has determined that, in addition to requiring respirators to achieve MOEs of greater

than 100, it is also requiring a label restriction that allows chemigation only in California and Arizona,

where extensive records show that the maximum acres treated via chemigation fall below the 200-acre

limit. The addition of these label restrictions to the current label requirements ensures that the dermal

risks from chemigation use will be below the Agency’s level of concern.

2) Golf Course and Professional Turf Uses

To address inhalation risk from the golf course and professional turf use scenarios discussed in

Section III of this document and shown in Table 7 of that section, respirators are required for the

following turf uses, in addition to the existing label requirements: 

– mixing/loading liquids; 

– loading granulars for tractor drawn spreader application; 

– applying granulars with a tractor drawn spreader;

– commercial or “for hire” applicators applying sprays with a groundboom sprayer; and 

– applying liquids with a low pressure/high volume turf gun by commercial or “for hire”

applicators.

The addition of respirators to the existing label requirements will mitigate all inhalation MOEs to

greater than 100, which would eliminate this risk concern.
41

To address dermal and inhalation risks, the following risk mitigation measures are required, in

addition to the existing label requirements:

– add respirators and coveralls for application with a push-type granular spreader;

– prohibit use of handheld application methods, such as the high pressure handwand,

backpack sprayer and handheld rotary application methods (e.g., bellygrinder); and

– allow use of the low pressure handwand for spot treatments only;

– delete use on ornamentals, parks and recreational areas.

Prohibiting the handheld application methods eliminate those risks entirely. Restricting use of the

low pressure handwand to spot treatments only would eliminate the Agency’s concern with this

application method. Table 7 shows the MOEs that are achieved for each scenario when the above

measures are considered in the assessment.

Dermal and inhalation risks remain, however, for the intermediate-term exposure from the pushtype granular spreader use at the high use rate, even with the addition of a respirator, gloves and

coveralls. The MOE is 74 for intermediate-term exposure, based on application to 5 acres per day at

the high use rate of 12.5 lbs./acre. With the same protective clothing requirements and the same 5 acre

treatment area, the MOE for intermediate-term exposure at the low use rate of 7.5 lbs./acre is 122, and

is not of concern. The Agency has reviewed its assumptions used in this assessment, and has

determined that treatment of 5 acres in one day using a push-type granular spreader is excessive. 

Applications to golf courses is the only remaining large turf use that can be treated with bensulide. 

Information received from the golf course industry indicates that, if a granular product in a push-type

spreader is used to treat parts of the course (e.g., greens and tees), this would be completed over 2-3 

days. More likely is that a tractor-drawn spreader would be used for these areas. Therefore, a shortterm exposure is a more accurate representation for this particular pattern of use; short-term MOEs are

greater than 100, even at the maximum use rate. Also, using a push-type spreader to treat 5 acres per

day for more than 7 days is unlikely, even for hired applicators. Most “for hire” applicators treating

large areas of turf for this amount of time would likely choose an alternative application method or

alternate this application method with others. Therefore, the intermediate-term risk estimate is probably

highly conservative, and respirators and coveralls would sufficiently mitigate this exposure scenario to an

acceptable level.

c. Homeowner Risk Mitigation

1) Handler Risk

To address dermal and inhalation risk to homeowners loading/applying granulars with a handheld

rotary method (e.g. bellygrinder), labels will prohibit this use. This measure will eliminate the risk of

concern. Use of a push-type spreader to apply granules resulted in MOEs that did not exceed the

Agency’s level of concern; therefore this use may continue. 
42

2) Post-Application Risk

 If the current label is not followed and bensulide is not watered-in extensively after application

at the maximum application rate (12.5 lbs ai/acre), then children involved in high exposure activities are

at risk (post-application MOE = 74). To address this post-application risk to children who enter lawns

treated with bensulide, product label language will be clarified to require extensive watering-in and

complete drying of the lawn before allowing persons or pets to enter the treated area. It will also direct

users to follow directions for safety reasons. As stated, bensulide is relatively expensive compared to

other alternatives, so it is more likely that a homeowner who buys it will follow the instructions and water

the product into the grass, to ensure its efficacy. Based on the Agency’s risk assessment, if the label is

followed and bensulide is watered-in, post-application exposure is not of concern for adults (including

golfers) and children. 

In addition to strengthening the label language on homeowner products, the Agency is prohibiting

the use of bensulide on all other non-golf course turf areas, such as parks and recreational areas. These

are areas where it may be difficult to follow the label instructions to thoroughly and immediately water-in

the product, and to restrict entry of children and pets until the area is dry. Prohibition of bensulide on

these areas will eliminate exposure entirely. 

2. Environmental Risk Mitigation

Generally, the environmental risk from bensulide use is to nontarget organisms resulting from use

on large turf areas, especially golf courses. This risk is due to the high use rates (7.5 to 12.5 lbs ai/acre),

the persistence of the chemical (the soil half-life is more than 200 days, based on laboratory studies) and

multiple applications (up to two times a year). Exposure to the environment may be significant, and

because bensulide is especially toxic to birds, small mammals, and some aquatic species, risk is of

concern. 

To address the risk to nontarget avian, mammalian, and aquatic species, a number of mitigation

measures are being implemented. Prohibition of use on ornamentals, parks and recreational areas will

reduce exposure to avian and mammalian species, and eliminate the potential for surface water run-off

that could affect aquatic organisms. While the use on golf course greens and tees will continue

unchanged, the use on fairways will be restricted to use on bentgrass in certain states, and to only one

application/year in the fall. Greens and tees are not expected to contribute to avian risk, since the grass

height is so low that these areas would not be conducive to foraging, and run-off from these areas is

expected to be minimal. Use on fairways constitutes a much larger area, and may result in surface water

run-off that could impact aquatic organisms. Also, birds and mammals may be attracted to these areas,

and feed and forage there. As discussed in the ecological risk section of this document, the endpoint of

concern for birds is eggshell thinning. Therefore, the Agency is particularly concerned about bensulide

use during the avian breeding season. 
43

Thus far, Gowan has agreed to limit the use on fairways to a single application of 12.5 pounds

ai/acre per year, and limit the use to bentgrass fairways only in 18 states. However, the Agency is

requiring that this use be restricted further, to allow a single application in the fall only, so that bensulide

is not applied during avian breeding periods, which are generally during the spring. Based on Agency

discussions with golf course superintendents and the registrant, bensulide has a very limited, but

important, use on fairways. It appears to have a niche market in some areas where other alternatives

may damage the fairway grass and where cost is secondary to overall performance. However, a number

of alternatives exist, and most, if not all, are less expensive alternatives to bensulide. 

The Agency initially determined that the fairway use of bensulide should be prohibited, but after

considering comments received during Phase 5 noting the importance of the niche use of the chemical, it

is allowing the single fall application to bentgrass fairways in 18 states. As an alternative to this fairway

restriction, the registrant may prohibit fairway use in its entirety. 

E. Other Labeling Requirements

The Agency is also requiring other use and safety information to be placed on the labeling of all

end-use products containing bensulide. For the specific labeling statements, refer to Section V of this

document

1. Endangered Species Statement

Currently, the Agency is developing a program ("The Endangered Species Protection Program")

to identify all pesticides whose use may cause adverse impacts on endangered and threatened species

and to implement mitigation measures that will eliminate the adverse impacts. The program would

require use restrictions to protect endangered and threatened species at the county level. Consultations

with the Fish and Wildlife Service may be necessary to assess risks to newly listed species or from

proposed new uses. In the future, the Agency plans to publish a description of the Endangered Species

Program in the Federal Register and have available voluntary county-specific bulletins. Because the

Agency is taking this approach for protecting endangered and threatened species, it is not imposing label

modifications at this time through the RED. 

In the future, the Agency plans to publish a description of the Endangered Species Program in

the Federal Register. EPA is in the process of developing county-specific bulletins that specify measures

to protect endangered and threatened species. Although bulletins have not yet been developed for all

counties where they will be needed, EPA has completed and distributed over 300 county bulletins.

2. Spray Drift Management

The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and

State Lead Agencies for pesticide regulation and other parties to develop the best spray drift 
44

management practices. The Agency is now requiring interim mitigation measures for aerial applications

that must be placed on product labels/labeling as specified in section V . The Agency has completed its

evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S.

pesticide registrants, and is developing a policy on how to appropriately apply the data and the

AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and

ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in

spray drift management practices to reduce off-target drift and risks associated with aerial as well as

other application types where appropriate. In the interim, the following spray drift related language is

required on product labels that are applied outdoors in liquid sprays (except mosquito adulticides),

regardless of application method:

"Do not allow this product to drift"

V. WHAT REGISTRANTS MUST DO

A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of bensulide for the above eligible uses has

been reviewed and determined to be substantially complete. The following data gaps remain: 

Guideline 830.6313 (Guideline #63-13) Stability of the TGAI on exposure to metals and

metal ions

Guideline 830.7050 UV/visible absorption for the PAI

Guideline 830.1800 (Guideline #62-3) Analytical Method

Guideline 850.4400 (Guideline #123-2) Aquatic Plant Growth and Reproduction Study with

Duckweed and a Freshwater Diatom

Guideline 850.4225 (Guideline #123-1(a)) Seedling Emergence, Tier II

Guideline 850.4250 (Guideline #123-1(b)) Vegetative Vigor, Tier II

N/A (Guideline #72-4(b)) Life Cycle Invertebrate 

Guideline 810.1000 (Guideline #90-1) Use/Usage Data

Guideline 860.1500 Crop Field Trials for fruiting vegetables (except cucurbits) on non-bell

peppers

Regarding the use and usage data cited above, as discussed in Section III, “Post Application

Occupational Risk,” the Agency is requesting that the technical registrant submit further information on

practices associated with agricultural transplanting operations. Specifically, the Agency is interested in

exposure to bensulide-treated soil that remains on the transplant wheel. 
45

Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate

pesticides currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18

64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity

studies; due dates are 9/2001. Registrant responses are under review.

2. Labeling Requirements for Manufacturing Use Products

To remain in compliance with FIFRA, manufacturing use product (MUP) labeling must be

revised to comply with all current EPA regulations, PR Notices and applicable policies. 

 All registrants must submit applications for amended registration. This application should

include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all

required label amendments outlined in Table 11 of this document incorporated, and a description on the

application, such as, "Responding to Interim Reregistration Eligibility Decision” document. All amended

labels must be submitted within 90 days of signature of this document. The Registration Division contact

for bensulide is Mr. Jim Tompkins. His phone number is (703) 305-5697. 

B. End-Use Products

1. Additional Generic Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data

regarding the pesticide after a determination of eligibility has been made. Registrants must review

previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to

conduct new studies. If a registrant believes that previously submitted data meet current testing

standards, then the study MRID numbers should be cited according to the instructions in the

Requirement Status and Registrants Response Form provided for each product. A product-specific

data call-in, outlining specific data requirements, accompanies this Interim RED.

2. Labeling Requirements for End-Use Products

Labeling changes are necessary to implement measures outlined in Section IV. Specific

language to implement these changes is specified in the Table 11 at the end of this section. Registrants

must submit applications for amended registration. This application should include the following items:

EPA application form 8570-1 (filled in), five copies of the draft label with all required label amendments

outlined in Table 11 of this document incorporated, and a description on the application, such as,

"Responding to Interim Reregistration Eligibility Decision” document. All amended labels must be

submitted within 90 days of signature of this document. The Registration Division contact for bensulide

is Mr. Jim Tompkins. His phone number is (703) 305-5697.
46

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 Interim Reregistration Eligibility Decision document. Persons other

than the registrant may generally distribute or sell such products for 24 months from the date of the

issuance of this Interim RED. However, existing stocks time frames will be established case-by-case,

depending on the number of products involved, the number of label changes, and other factors. Refer to

“Existing Stocks of Pesticide Products; Statement of Policy”; Federal Register, Volume 56, No. 123,

June 26, 1991.

The Agency has determined that registrant may distribute and sell bensulide products bearing old

labels/labeling for 12 months from the date of issuance of this Interim RED. Persons other than the

registrant may distribute or sell such products for 24 months from the date of the issuance of this Interim

RED. Registrants and persons other than the registrant remain obligated to meet pre-existing Agency

imposed label changes and existing stocks requirements applicable to products they sell or distribute.
47

D. Required Labeling Changes Summary Table

Table 11: Summary of Required Labeling Changes for Bensulide

Description Required Labeling Placement on Label

Manufacturing Use Products

One of these statements

may be added to a label

to allow reformulation of

the product for a specific

use or all additional uses

supported by a formulator

or user group

“Only for formulation into an herbicide for the following use(s) [fill blank only with those uses

that are being supported by MP registrant].”

Directions for Use

“This product may be used to formulate products for specific use(s) not listed on the MP label

if the formulator, user group, or grower has complied with U.S. EPA submission requirements

regarding support of such use(s).”

“This product may be used to formulate products for any additional use(s) not listed on the

MP label if the formulator, user group, or grower has complied with U.S. EPA submission

requirements regarding support of such use(s).”

Directions for Use

Environmental Hazards

Statements Required by

the RED and Agency

Label Policies 

"This chemical is toxic to fish and aquatic invertebrates, and poses a risk to reproduction of

birds. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,

oceans or other waters unless in accordance with the requirements of a National Pollutant

Discharge Elimination System (NPDES) permit and the permitting authority has been notified

in writing prior to discharge. Do not discharge effluent containing this product to sewer

systems without previously notifying the local sewage treatment plant authority. For guidance

contact your state Water Board or Regional Office of the EPA.” (Insert any additional

chemical specific manufacturing use environmental hazards here)

Directions for Use
Description Required Labeling Placement on Label

48

End Use Products Intended for Occupational Use (WPS)

PPE Requirements

Established by the RED1

for liquid products

“Personal Protective Equipment (PPE)

Some materials that are chemical-resistant to this product are (registrant inserts correct

material as per supplements 3 of PR Notice 93-7). 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.”

“Mixers, loaders, applicators and other handlers must wear:

* long-sleeved shirt and long pants,

* chemical-resistant gloves,

* shoes plus socks

In addition, a NIOSH-approved dust-mist filtering respirator with MSHA/NIOSH approval

number prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter

must be worn by 1) mixers, loaders, 2) persons participating in chemigation, and 3)

commercial or for-hire applicators (due to risk from repeated exposures).”

Immediately

following/below 

Precautionary

Statements: Hazards to

Humans and Domestic

Animals 

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
Description Required Labeling Placement on Label

49

Engineering Controls “Engineering Controls”

“When handlers use closed systems or enclosed cabs, in a manner that meets the

requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides (40

CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified as

specified in the WPS.” 

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

gloves before removing. As soon as possible, wash thoroughly and change into clean

clothing.”

Precautionary

Statements under: 

Hazards to Humans and

Domestic Animals

immediately following

Engineering Controls

(Must be placed in a

box.)
Description Required Labeling Placement on Label

50

Environmental Hazards “Environmental Hazards”

"This chemical is toxic to fish and aquatic invertebrates. Do not apply directly to water, or to

areas where surface water is present or to intertidal areas below the mean high water mark. 

Do not contaminate water when disposing of equipment washwater or rinsate. Do not apply

when weather conditions favor drift from the treated area.”

“This product is highly toxic to bees exposed to direct treatment or residues on blooming

crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if

bees are visiting the treatment area.” 

“Do not apply directly to water, or to area where water is present or to intertidal areas below

the mean high water mark. Do not contaminate water when cleaning equipment or disposing

of equipment washwaters.”

“This product may impair reproduction in birds if used during the breeding season.” 

Precautionary

Statements immediately

following the User

Safety

Recommendations

Restricted-Entry Interval “Do not enter or allow worker entry into treated areas during the restricted entry interval

(REI) of 12 hours.”

Directions for Use,

Agricultural Use

Requirements Box

Early Re-entry Personal

Protective Equipment

established by the RED. 

“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 (such as, or made of, any waterproof material),

*shoes plus socks”
Description Required Labeling Placement on Label

51

General Application

Restrictions

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

or through drift. Only protected handlers may be in the area during application.” Place in the Direction

for Use directly above

the Agricultural Use

Box. 

Chemigation Restrictions “This product may only be applied by chemigation in Arizona and California” Directions for Use

Aerial Application and

Spray Drift Restrictions

“This product may not be applied by aircraft.”

“Do not allow this product to drift.”

Directions for Use in

General Precautions

and Restrictions

End Use Products Intended for Occupational Use (Non-WPS)

PPE Requirements

Established by the RED1

for Liquid Products

“Personal Protective Equipment (PPE)

Some materials that are chemical-resistant to this product (registrant inserts chemical resistant

material as per instructions in Supplement Three of PR Notice 93-7). 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.”

“Mixers and loaders must wear:

* long-sleeved shirt and long pants,

* chemical-resistant gloves,

* shoes plus socks

*a NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number

prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter.

Applicators and other handlers must wear:

* long-sleeved shirt and long pants.

Precautionary

Statements under

Hazards To Humans

and Domestic Animals
Description Required Labeling Placement on Label

52

PPE Requirements

Established by the RED1

for Granular Products

“Personal Protective Equipment (PPE)

Some materials that are chemical-resistant to this product (registrant inserts chemical resistant

material as per instructions in Supplement Three of PR Notice 93-7). 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.”

“ Applicators using a push type spreader and all loaders must wear:

* coveralls over long-sleeved shirt and long pants,

* chemical resistant gloves,

* chemical resistant footwear plus socks”

* a NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number

prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter.

All other applicators and handlers must wear:

* long-sleeved shirt and long pants,

* chemical-resistant gloves

* shoes plus socks

In addition to the above, for-hire applicators ( non-golf-course employees) must wear a

NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number prefix

TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter (due to risk from

repeated exposures) when applying this product to golf courses.”

Precautionary

Statements under

Hazards To Humans

and Domestic Animals
Description Required Labeling Placement on Label

53

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 

for liquid products

“Engineering Controls”

“When handlers use closed systems or enclosed cabs in a manner that meets the requirements

listed in the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR

170.240(d)(4-6), the handler PPE requirements may be reduced or modified as specified in

the WPS.” 

Precautionary

Statements: Hazards to

Humans and Domestic

Animals (Immediately

following PPE and User

Safety Requirements.)

Engineering Controls 

for granular products

“Engineering Controls”

“When handlers use enclosed cabs in a manner that meets the requirements listed in the

Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the

handler PPE requirements may be reduced or modified as specified in the WPS.” 

Precautionary

Statements: Hazards to

Humans and Domestic

Animals (Immediately

following PPE and User

Safety Requirements.)

User Safety

Recommendations

See User Safety Recommendations for WPS above. Placed in a box in the

Precautionary

Statements under

Hazards to Humans and

Domestic Animals

immediately following

Engineering Controls. 
Description Required Labeling Placement on Label

54

Environmental Hazards “Environmental Hazards”

"This chemical is toxic to fish and aquatic invertebrates. Do not apply directly to water, or to

areas where surface water is present or to intertidal areas below the mean high water mark. 

Do not contaminate water when disposing of equipment washwater or rinsate. Do not apply

when weather conditions favor drift from the treated area.”

“This product is highly toxic to bees exposed to direct treatment or residues on blooming

crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if

bees are visiting the treatment area.” 

“Do not apply directly to water, or to area where water is present or to intertidal areas below

the mean high water mark. Do not contaminate water when cleaning equipment or disposing

of equipment washwaters.”

“This product may impair reproduction in birds if used during the breeding season.”

Precautionary

Statements following

the User Safety

Recommendations

under the Heading

“Environmental

Hazards”

Watering-In/Entry

Restriction

“IMPORTANT: THIS PRODUCT WILL NOT WORK UNLESS IT IS WATERED IN

FOR 10-15 MINUTES. FOR SAFETY REASONS, WATER THIS PRODUCT IN AS

SOON AS POSSIBLE FOLLOWING APPLICATION FOR 10-15 MINUTES AND

DO NOT ALLOW CHILDREN OR PETS ON TREATED AREAS UNTIL DRY

FOLLOWING THE WATERING.”

“WATERING-IN MUST BE PERFORMED BY THE COMMERCIAL APPLICATOR

OR THE COMMERCIAL APPLICATOR MUST PROVIDE THE ABOVE

WATERING-IN INSTRUCTIONS TO THE RESIDENT IN WRITING USING BOLDFACE TYPE AND/OR RED PRINT OR OTHER METHODS TO ENSURE THE

WARNING IS PROMINENTLY DISPLAYED ON THE MATERIAL PROVIDED TO

THE RESIDENT.”

Directions for Use

Under General

Precautions and

Restrictions
Description Required Labeling Placement on Label

55

Application Restrictions “Do not apply this product in a way that will contact workers or other persons”

“For use only on golf courses (greens, tees and bentgrass fairways only) and on residential

lawns.”

“Do not use on parks, recreational areas, or other public sites.”

“Applications on bentgrass fairways is limited to following states: OH, PA, NY, MI, CT, MA,

IN, IL, NJ, WV, MN, WI, VT, NH, RI, DE, MD, VA”). “Applications on bentgrass

fairways may only be made in the Fall and are limited to one application per year.” 

“Applications to greens and tees are limited to two per year”

Note: The following sites must be removed from the label:

* fairways (unless as specified above)

* parks

* recreational areas

* ornamentals

* groundcovers

Directions For Use

under General

Precautions and

Restrictions 

Application Equipment

Restrictions (granular

products)

“This product may only by applied by tractor-drawn spreader or by push type spreader.”

Note: All other equipment (except as specified above) must be removed from the label.

Direction for Use under

General Precautions

and Restrictions

Application Equipment

Restrictions (liquid

products)

“This product may only be broadcast applied by groundboom or by low pressure/high volume

turfgun. This product may be applied by low pressure handwand for spot treatments only.”

Note: All other application equipment (except as specified above) must be removed from the

label.

Direction for Use under

General Precautions

and Restrictions
Description Required Labeling Placement on Label

56

End Use Products Intended Primarily for Use by Homeowners

Application Restrictions “Do not apply this product in a way that will contact people or pets” Directions for Use

under General

Precautions and

Restrictions

Application/Entry

Restriction

“IMPORTANT: THIS PRODUCT WILL NOT WORK UNLESS IT IS WATERED IN

FOR 10-15 MINUTES. FOR SAFETY REASONS, WATER THIS PRODUCT IN AS

SOON AS POSSIBLE FOLLOWING APPLICATION FOR 10-15 MINUTES AND

DO NOT ALLOW CHILDREN OR PETS ON TREATED AREAS UNTIL DRY

FOLLOWING THE WATERING.”

Directions for Use

under General

Precautions and

Restrictions

Statement must be in

the color red and in all

caps.

Application Equipment

Restrictions

“This product may only be applied by a push-type spreader. Hand-held rotary broadcast

spreaders are prohibited.”

Directions for Use

under General

Precautions and

Restrictions

1

 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. 

The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-

7.

2

 If the product contains oil or bears instructions that will allow application with an oil-containing material, the “N” designation must be dropped.

Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.

Instructions in the Labeling Required section not in quotes represents actions that the registrant must take to amend their labels or product

registrations.
57

VI. RELATED DOCUMENTS AND HOW TO ACCESS THEM

This Interim Reregistration Eligibility Document is supported by documents that are presently

maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921

Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays

from 8:30 am to 4 pm.

The docket initially contained preliminary risk assessments and related documents as of

September 10, 1998. Sixty days later the first public comment period closed. The EPA then

considered comments, revised the risk assessment, and added the formal “Response to Comments”

document and the revised risk assessment to the docket on July 7, 1999. 

All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or

viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op."
58
59

VII. APPENDICES
60
61

Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR INTERIM REREGISTRATION

Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

Food/Feed Uses

Brassica (Cole) Leafy Vegetables Group3

Preplant incorporated or

preemergence

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.

Carrots

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

4 lb/gal EC

6 lb/gal EC 

5.0 lb/A 1/crop

cycle

5.0 lb/A 12 hours Use limited to TX. Feeding treated carrots to

livestock is prohibited. Labels must be

amended to reflect a maximum seasonal use

rate of 5 lb/A.
Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

62

Cucurbit Vegetables Group4

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Application may be made alone or as tank mix

with ALANAP® (naptalam) for weed control

in cantaloupes, cucumbers, muskmelons, and

watermelons,. Tank mix use prohibited in CA.

Chemigation may only occur in California and

Arizona.

Fruiting Vegetables Group5

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.

Labels must be amended to restrict use to bell

peppers only unless three required non-bell

pepper field trials are conducted. 
Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

63

Garlic

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.

Seed bed preparation (fall)

Soil band and bed-up

(groundboom)

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Use limited to ID and OR. 

Leafy Vegetables (except Brassica Vegetables) Group6

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.
Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

64

Onions, Bulb

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC 

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.

Preplant (fall) 

Soil band and bed-up

(groundboom)

4 lb/gal EC 

6 lb/gal EC

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Use limited to ID and OR. 

Application through any type of irrigation

system is prohibited.

4 lb/gal EC

6 lb/gal EC

3.0 lb/A 1/crop

cycle

3.0 lb/A 12 hours Use limited to OR and WA. Application

through any type of irrigation system is

prohibited.
Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

65

Onions, Bulb (Continued)

Postplant incorporated, at

layby

Soil band treatment

(groundboom)

Chemigation

4 lb/gal EC 6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Use limited to AZ for onions grown for seed. 

Not for feed use or human consumption. 

Feeding to animals is prohibited. 

Shallots

Preplant incorporated or

preemergence 

Soil broadcast/band treatment

(groundboom)

Chemigation

4 lb/gal EC

6 lb/gal EC

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Chemigation may only occur in California and

Arizona.

Seed bed preparation (fall)

Soil band and bed-up 

(groundboom)

4 lb/gal EC

6 lb/gal EC

6.0 lb/A 1/crop

cycle

6.0 lb/A 12 hours Use limited to ID and OR. 

Application through any type of irrigation

system is prohibited.
Site

Application Type

Formulation

% AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps

Max. Seasonal

 Total

Agricultural

Reentry

Interval1 Restrictions/Comments2

66

Field Grown Herbaceous Plants

Preplant or preemergence to

flatplanted or bedded crops.

Groundboom

Chemigation

4 lb/gal EC 9.0 lb/A 1/yr 1 12 hours Chemigation may only occur in California and

Arizona.

May not be used in residential areas.

Field Grown Bulbs 

Preplant or preemergence to

flatplanted or bedded crops.

Groundboom

Chemigation

4 lb/gal EC 9.0 lb/A 1/yr 1 12 hours Chemigation may only occur in California and

Arizona.

May not be used in residential areas.

1. The restricted entry interval (REI) for the 4 and 6 lb/gal EC formulations is 12 hours, except if the product is soil-injected or soil-incorporated. Then

workers are allowed to enter the treated area if there will be no contact with anything that has been treated.

2. The following rotational crop restrictions are established for the 4 and 6 lb/gal EC formulations: carrots, cotton, and crops on the label (or crops from

labeled crop groupings) may be replanted following application, without restrictions. A 120 day plantback interval has been established for all other

crops, and the soil must be tilled to minimum of 4 inches prior to replanting.

3. Includes broccoli, broccolini, broccoflower, Chinese broccoli, broccoli raab (rapini), brussels sprouts, cabbage, Chinese cabbage (bok choy, napa),

Chinese mustard cabbage (gai choy) cauliflower, cavalo broccolo, collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, and rape greens.
67

4. Includes chayote, Chinese waxgourd (Chinese preserving melon), citron melon, cucumbers, gherkin, edible gourd (hechima, Chinese okra), muskmelons

(including muskmelon, true cantaloupe, cantaloupe, casaba, Crenshaw melon, golden pershaw melon, honeydew melon, honey balls, mango melon,

Persian melon, pineapple melon, Santa Claus melon, snake melons), pumpkins, summer squash (crookneck squash, straightneck squash, zucchini, scallop

squash, vegetable marrow, spaghetti squash, hyotan, cucuzza, balsam apple, balsam pear, bitter melon, Chinese cucumber), winter squash (including

butternut squash, calabaza, hubbard squash, acorn squash), and watermelons.

5. Includes eggplant, ground cherry, pepinos, peppers (bell peppers, chili peppers, cooking peppers, pimentos, sweet peppers), and tomatillo. However, all

labels must be amended to restrict use to bell peppers only unless three required non-bell pepper field trials are conducted. 

6. Includes arugula (roquette), cardoon, celery, Chinese celery, celtuce, chervil, chrysanthemum (edible leafed garland), corn salad, cress (garden, upland),

dandelion, dock (sorrel), endive (escarole), Florida fennel, lettuce (head or leaf), orach, parsley, radicchio (red chicory), and Swiss chard.

7. Alyssum, aster, bachelor’s button, calendula, candy-tuft, coral bell, daisy, marigold, pansy, primrose, stock, sweet pea, wallflower.

8. Daffodil, dahlia, freesia, gladiolus, narcissus, ranunculus, tulip. 
68

Site

Application Type

Formulation

%AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps/Yr

Max. Yearly

 Total

 Reentry

Interval Restrictions/Comments

Turf Uses

Golf Course–Greens and Tees

Groundboom

Tractor drawn spreader

Drop spreader 

Low pressure hand wand

3.6-12.5 lbs AI/

100 lbs. 

Granular 

4-12.5 lb/gal 

EC

12.5

12.5

2

2

25 lb/A

25 lb/A

N/A

N/A

Low pressure hand wand

may be used for spot

treatment only. 

All other hand-held

application methods are

prohibited. 
Site

Application Type

Formulation

%AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps/Yr

Max. Yearly

 Total

 Reentry

Interval Restrictions/Comments

69

Golf Course–Fairways

Groundboom

Tractor drawn spreader

Drop spreader

Low pressure hand wand

3.6-12.5 lbs AI/

100 lbs.

Granular 

4-12.5 lb/gal EC

12.5

12.5

1

1

12.5 lb/A

12.5 lb/A

N/A

N/A

May only be applied one

time in the Fall. May only

be applied to bentgrass

fairways in the following

states: OH, PA, NY, MI,

CT, MA, IN, IL, NJ, WV,

MN, WI, VT, NH, RI, DE,

MD, VA.

Low pressure hand wand

may be used for spot

treatment only. All other

hand-held methods are

prohibited. 

May not be used on parks,

recreational areas, or

ornamentals and ground

covers.
Site

Application Type

Formulation

%AI

Max. Single

Application

Rate

(lb ai/A)

Max.#

Apps/Yr

Max. Yearly

 Total

 Reentry

Interval Restrictions/Comments

70

Home Lawns

Drop spreader 3.6-12.5 lbs AI/

100 lbs.

Granular

12.5 2 25 lb N/A May not be used on parks,

recreational areas, or

ornamentals and ground

covers.

Do not use a bellygrinder

or any other hand-held

method when applying. 
71

Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES

USED TO MAKE THE INTERIM REREGISTRATION DECISION

GUIDE TO APPENDIX B

Appendix B contains listing of data requirements which support the reregistration for active

ingredients within case #2035 (bensulide) covered by this Interim RED. It contains generic data requirements

that apply to bensulide in all products, including data requirements for which a "typical formulation" is the test

substance. 

The data table is organized in the following formats:

1. Data Requirement (Column 1). The data requirements are listed in the order in which they

appear in 40 CFR part 158. the reference numbers accompanying each test refer to the test

protocols set in the Pesticide Assessment Guidance, which are available from the National

technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-

4650.

2. Use Pattern (Column 2). This column indicates the use patterns for which the data

requirements apply. The following letter designations are used for the given use patterns. 

A. Terrestrial food

B. Terrestrial feed

C. Terrestrial non-food

D. Aquatic food

E. Aquatic non-food outdoor

F. Aquatic non-food industrial 

G. Aquatic non-food residential

H. Greenhouse food

I. Greenhouse non-food

J. Forestry

K. Residential

L. Indoor food

M. Indoor non-food

N. Indoor medical

O. Indoor residential

3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column

list the identify number of each study. This normally is the Master Record Identification

(MIRD) number, but may be a "GS" number if no MRID number has been assigned. Refer

to the Bibliography appendix for a complete citation of the study.
72

APPENDIX B

Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

PRODUCT CHEMISTRY

830.1550 61-1 Product Identity and Composition All 41532001, 00163310, 00088284, 42685001

830.1600 61-2A Start. Mat. & Mnfg. Process All 00163310, 00088284

830.1670 61-2B Formation of Impurities All 00163310, 00088284

830.1700 62-1 Preliminary Analysis All 40033501, 00163299

830.1750 62-2 Certification of limits All 40033501, 00163299

830.1800 62-3 Analytical Method All DATA GAP

830.6302 63-2 Color All 41532001, 00157314

830.6303 63-3 Physical State All 41532001, 00157314

830.6304 63-4 Odor All 41532001, 00157314

830.7050 UV/Visible Absorption All DATA GAP

830.7200 63-5 Melting Point All 41532001, 00157314

830.7220 63-6 Boiling Point All 41532001, 00157314

830.7300 63-7 Density All 41532001, 42685001

830.7840

830.7860

63-8 Solubility All 41532001, 00157314

830.7950 63-9 Vapor Pressure All 41532001, 00157314
Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

73

830.7370 63-10 Dissociation Constant All 41532001, 00157314

830.7550 63-11 Octanol/Water Partition Coefficient All 41532001, 00157314

830.7000 63-12 pH All 41532001, 00157314

830.6313 63-13 Stability All DATA GAP

830.7100 63-18 Viscosity All 41532001

830.6319 63-19 Miscibility All 41532001

830.6320 63-20 Corrosion characteristics All 00157314

ECOLOGICAL EFFECTS

850.2100 71-1 Avian Acute Oral Toxicity A,C,K 00158455

850.2200 71-2A Avian Dietary Toxicity - Quail A,C,K 43616001, 00158456

850.2200 71-2B Avian Dietary Toxicity - Duck A,C,K 00158457

850.2400 71-3 Wild Mammal Toxicity A,C,K 92005011

850.2300 71-4A Avian Reproduction - Quail A,C,K 43616001, 43121901, 44486901

850.2300 71-4B Avian Reproduction - Duck A,C,K 43121902, 43616001, 43616002, 44486901

850.1075 72-1A Fish Toxicity Bluegill A,C,K 41931001, 00157316

850.1075 72-1C Fish Toxicity Rainbow Trout A,C,K 00157315, 40098001

850.1010 72-2A Invertebrate Toxicity A,C,K WAIVED

72-3A Estuarine/Marine Toxicity - Fish A,C,K WAIVED, 42750201, 40228401
Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

74

72-3B Estuarine/Marine Toxicity - Mollusk A,C,K 42750202, 40228401

72-3C Estuarine/Marine Toxicity - Shrimp A,C,K 42750203, 40228401

72-4A Fish- Early Life Stage A,C,K 44720408

72-4B Estuarine/Marine Invertebrate Life

Cycle

A,C,K DATA GAP, 44720407

850.1500 72-5 Life Cycle Fish A,C,K Data may be required depending on results of

fish-early life stage study

123-1 Non-target Terrestrial Plant

Phytotoxicity

A,C,K DATA GAP

850.4400 123-2 Aquatic Plant Growth A,C,K DATA GAP, 44720402, 44720404, 44720405,

44720406

123-3 Aquatic Plant Toxicity A,C,K 44720403

850.3020 141-1 Honey Bee Acute Contact A,C,K 00036935

TOXICOLOGY

870.1100 81-1 Acute Oral Toxicity-Rat A,C,K 00097921, 92005011

870.1200 81-2 Acute Dermal Toxicity-Rabbit/Rat A,C,K 41597501, 00097921

870.1300 81-3 Acute Inhalation Toxicity-Rat A,C,K 41646201

870.2400 81-4 Primary Eye Irritation-Rabbit A,C,K 41597502

870.2500 81-5 Primary Skin Irritation A,C,K 00097921, 92005012

870.2600 81-6 Dermal Sensitization A,C,K 00160075
Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

75

870.6100 81-7 Acute Delayed Neurotoxicity - Hen A,C,K 43334302, 43306301, 00131485

870.6200 81-8 Acute Neurotoxicity Screen A,C,K 43195901

870.3100 82-1A 90-Day Feeding - Rodent A,C,K 43919601

870.3150 82-1B 90-Day Feeding - Non-rodent A,C,K 44052703

870.3200 82-2 21-Day Dermal - Rabbit/Rat A,C,K 44801101, 44809401, 42162002

870.4100 83-1A Chronic Feeding Toxicity - Rodent A,C,K 43919602, 44161101, 00132002

870.4100 83-1B Chronic Feeding Toxicity - NonRodentA,C,K 44052701, 44052702, 44052703, 44066401,

44052704

870.4200 83-2A Oncogenicity - Rat A,C,K 43919602, 44161101, 00132002

870.4200 83-2B Oncogenicity - Mouse A,C,K 44161105

870.3700 83-3A Developmental Toxicity - Rat A,C,K 00146585

870.3700 83-3B Developmental Toxicity - Rabbit A,C,K 42864201, 00152845

870.3800 83-4 2-Generation Reproduction - Rat A,C,K 43948701, 00131486

870.4300 83-5 Combined Chronic Toxicity/

Carcinogenicity

A,C,K 43919602, 44161101

870.5140 84-2A Gene Mutation (Ames Test) A,C,K 00153493, 41902601

870.5375 84-2B Structural Chromosomal Aberration A,C,K 41902601, 41902602, 42479201

84-4 Other Genotoxic Effects A,C,K 43273901
Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

76

870.7485 85-1 General Metabolism A,C,K 42225401, 42007901, 42007902, 42007903,

42007904 

ENVIRONMENTAL FATE

160-5 Chemical Identity A,C,K 00163310, 00088284

835.2120 161-1 Hydrolysis A,C,K 00160074

835.2240 161-2 Photodegradation - Water A,C,K 40513401

835.2410 161-3 Photodegradation - Soil A,C,K 42162001

835.2370 161-4 Photodegradation - Air A,C,K 41532001

835.4100 162-1 Aerobic Soil Metabolism A,C,K 40460301

835.4200 162-2 Anaerobic Soil Metabolism A,C,K 40460302

835.1240 163-1 Leaching/Adsorption/Desorption A,C,K 42826701, 43180701, 43180702, 00162706

835.6100 164-1 Terrestrial Field Dissipation A,C,K 44908801

835.1850 165-1 Confined Rotational Crop A,C,K 43459201, 42578002

165-4 Bioaccumulation in Fish A,C,K 41931001

RESIDUE CHEMISTRY

171-2 Chemical Identity A 00163310, 00088284

860.1300 171-4A Nature of Residue - Plants A 44223801, 42578001, 42507901, 42350401,

42281301

860.1340 171-4C Residue Analytical Method - Plants A 92005036
Data Supporting Guideline Requirements for the Interim Reregistration of Bensulide

New Guideline

Number

Old Guideline

Number REQUIREMENT USE 

PATTERN CITATION(S)

77

860.1380 171-4E Storage Stability A 43975701, 41597503

860.1500 171-4K Crop Field Trials 

(Bulb Vegetables)

A 43665702, 43638201, 43334301

860.1500 171-4K Crop Field Trials (Carrot) A 43755902, 43494401

860.1500 171-4K Crop Field Trials (Cucumber) A 43782601 

860.1500 171-4K Crop Field Trials (Cucurbit

Vegetables)

A 43775201, 92005037, 92005038, 92005039

860.1500 171-4K Crop Field Trials (Fruiting

Vegetables)

A DATA GAP FOR NON-BELL PEPPERS;

43711302, 92005041, 92005040, 00028822,

92005033, 92005034

860.1500 171-4K Crop Field Trials (Leafy Vegetables) A 43764201, 43755901, 43746201, 43699901,

43682001, 43682002, 43676402

860.1500 171-4K Crop Field Trials (Peppers) A 43755901, 43744701, 43711301, 43665701,

43672801

OTHER

810.1000 90-1 Use/Usage Data A,B,H,I,L,M DATA GAP
78
79

Appendix C. TECHNICAL SUPPORT DOCUMENTS

Additional documentation in support of this RED is maintained in the OPP docket, located in Room

119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday,

excluding legal holidays, from 8:30 am to 4 pm.

The docket initially contained preliminary risk assessments and related documents as of August 10,

1998. Sixty days later the first public comment period closed. The EPA then considered comments, revised

the risk assessment, and added the formal “Response to Comments” document and the revised risk

assessment to the docket on June 16, 1999. 

All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or

viewed via the Internet at the following site:

www.epa.gov/pesticides/op

These documents include:

HED Documents:

1. Human Health Risk Assessment, Bensulide

2. Acute and Chronic Dietary Exposure Analyses for the Revised HED

Reregistration Eligibility Decision Document (RED)

3. Revised Occupational and Residential Reregistration Eligibility Document for

Bensulide

4. Product Chemistry

5. Revised Estimated Environmental Concentrations in Ground and Surface

Water for Bensulide used on Golf Course Fairways

EFED Documents:

a. Environmental Risk Assessment, Bensulide

b. Review of Additional Data for Bensulide (Chemical # 009801) and

Addendum of the Ecological Risk Assessment for Reregistration.

c. Updates to the Risk Assessment of the Bensulide RED, Based on Recently

Submitted Data on Persistence of Residues on Grass.
80
81

Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE

SUPPORTING THE INTERIM REREGISTRATION DECISION

(BIBLIOGRAPHY)

GUIDE TO APPENDIX D

1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies

considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the

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

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

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

where they have been considered, are included.

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

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

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

published article from within the typically larger volumes in which they were submitted. The

resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for

purposes of review and can be described with a conventional bibliographic citation. The

Agency has also attempted to unite basic documents and commentaries upon them, treating

them as a single study.

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

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

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

Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)

below for further explanation). In a few cases, entries added to the bibliography late in the

review may be preceded by a nine character temporary identifier. These entries are listed after

all MRID entries. This temporary identifying number is also to be used whenever specific

reference is needed.

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

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

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

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

special needs.

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

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

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

could be identified, the Agency has shown the first submitter as the author.
82

b. Document date. The date of the study is taken directly from the document. When the

date is followed by a question mark, the bibliographer has deduced the date from the

evidence contained in the document. When the date appears as (1999), the Agency

was unable to determine or estimate the date of the document.

c. Title. In some cases, it has been necessary for the Agency bibliographers to create or

enhance a document title. Any such editorial insertions are contained between square

brackets.

d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing

parentheses include (in addition to any self-explanatory text) the following elements

describing the earliest known submission:

(1) Submission date. The date of the earliest known submission appears

immediately following the word "received."

(2) Administrative number. The next element immediately following the word

"under" is the registration number, experimental use permit number, petition

number, or other administrative number associated with the earliest known

submission.

(3) Submitter. The third element is the submitter. When authorship is defaulted to

the submitter, this element is omitted.

(4) Volume Identification (Accession Numbers). The final element in the trailing

parentheses identifies the EPA accession number of the volume in which the

original submission of the study appears. The six-digit accession number

follows the symbol "CDL," which stands for "Company Data Library." This

accession number is in turn followed by an alphabetic suffix which shows the

relative position of the study within the volume.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

83

00028822 Nuarhart, J.; Hachadorian, K.; Bayes, G.; et al. (1971) Crop Residue Report: FSDS

No. B-1098. (Unpublished study including FSDS nos. B-1747, A-0214, B-0636...,

received Jan 25, 1972 under 476-2004; prepared in cooperation with Texas A & M

Univ. and Univ. of Kansas, submitted by Stauffer Chemical Co., Richmond, Calif.;

CDL:003867-E)

00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides and

Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By University of

California, Dept. of Entomology. ?: UC, Cooperative Extension. (Leaflet 2287;

published study.)

00088284 Stauffer Chemical Company (1976) [Composition of Betasan]. (Compilation;

unpublished study received Mar 2, 1978 under 476-2106; CDL:232972-B)

00097921 Castles, T.R. (1978) Toxicity EValuation: Betasan: Toxicology Laboratory Report

T-6389. (Unpublished study received Mar 2, 1978 under 476-2106; submitted by

Stauffer Chemical Co., Richmond, Calif.; CDL:232972-E)

00131485 Sprague, G.; Bickford, A. (1982) Acute Delayed Neurotoxicity Study with Betasan

Technical in Adult Hens: T-6490. (Unpublished study received Oct 7, 1983 under

476-2106; submitted by Stauffer Chemical Co., Richmond, CA; CDL:251475-A) 

00131486 Goldenthal, E.; Jessup, D.; Geil, R.; et al. (1978) 3 Generation Reproduction Study in

Rats: [Prefar (Betasan) Tech.]: 153-017. (Unpublished study received Oct 7, 1983

under 476-2106; prepared by International Research and Development Corp.,

submitted by Stauffer Chemical Co., Richmond, CA; CDL:251476-A)

00132002 Trutter, J.; Mossburg, P. Howard, J.; et al. (1979) 24-Month Chronic Feeding Study

in Rats: Prefar (Betasan) Technical: Project No. 132-132. Final rept. (Unpublished

study received Oct 7, 1983 under 476-2106; prepared by Hazleton Laboratories

America, Inc., submitted by Stauffer Chemical Co., Richmond, CA; CDL: 251477-A)

00146585 Minor, J. (1985) A Teratology Study in CD Rats with Betasan: T-11896. 

Unpublished study prepared by Stauffer Chemical Co. 264 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

84

00152845 Clevidence, K. (1985) A Teratology Study in Rabbits with Betasan: Final Report:

Project No. WIL-27025. Unpublished Stauffer Chemical Company's Study No.

T-12093 prepared by Wil Research Laboratories, Inc. 165 p.

00153493 Majeska, J. (1984) Mutagenicity Evaluation in Salmonella typhimurium: Prefar (Betasan

Technical): Report No. T-11917. Unpublished report prepared by Stauffer Chemical

Co. 16 p. 

00157314 Lee, K.; Yu Farina, L. (1986) Odor, Corrosion Rate, and Octanol Water Partition

Coefficient of Bensulide: Report No. RRC 86-10. Unpublished study prepared by

Stauffer Chemical Co. 20 p.

00157315 McAllister, W.; Swigert, J.; Bowman, J. (1986) Acute Toxicity of Betasan Technical to

Rainbow Trout (Salmo gairdneri): Static Acute Toxicity Report #34028: T-12395. 

Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 51 p.

00157316 McAllister, W.; Swigert, J.; Bowman, J. (1986) Acute Toxicity of Betasan Technical to

Bluegill Sunfish (Lepomis macrochirus): Static Acute Toxicity Report #34027:

T-12394. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 

47 p.

00158455 Grimes, J. (1986) Betasan Technical: An Acute Oral Toxicity Study with the Bobwhite:

Final Report: Project No. 144-136. Unpublished study prepared by Wildlife

International Ltd. 19 p. 

00158456 Grimes, J. (1986) Betasan Technical: A Dietary LC50 Study with the Bobwhite: Final

Report: Project No. 144-134. Unpublished study prepared by Wildlife International

Ltd. 16 p. 

00158457 Grimes, J. (1986) Betasan Technical: A Dietary LC50 Study with the Mallard: Final

Report: Project No. 144-135. Unpublished study prepared by Wildlife International

Ltd. 17 p.

00159322 Forbis, A.; Burgess, D.; Frazier, S. (1986) Acute Toxicity of Betasan Technical to

Daphnia magna: Static Acute Toxicity Report #34029. Unpublished study prepared by

Analytical Bio-Chemistry Laboratories, Inc. 36 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

85

00160074 Chang, L.; Lee, K. (1986) Hydrolysis Studies of Bensulide: Report No. RRC 86-50. 

Unpublished study prepared by Stauffer Chemical Co. 36 p.

00160075 Davis, M.; Mutter, L. (1986) Dermal Sensitization Test with Betasan Technical:

T-12411. Unpublished study prepared by Stauffer Chemical Co. 38 p.

00162706 Parker, D. (1986) Bensulide Selective Herbicide Soil Leaching Study: Laboratory

Project ID: PMS-203; MRC-86-10. Unpublished study prepared by Stauffer

Chemical Co. 34 p.

00163299 Stauffer Chemical Co. (1986) Product Chemistry: Betasan Technical. Unpublished

study. 292 p.

00163310 Stauffer Chemical Co. (1986) Product Chemistry: Betasan Technical. Unpublished

study. 68 p.

 00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides and

Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By University of

California, Dept. of Entomology. UC, Cooperative Extension. (Leaflet 2287;

published study.)

05001497 Sanders, H.O. (1970) Toxicities of some herbicides to six species of freshwater

crustaceans. Journal of the Water Pollution Control Federation 42(8):1544-1550.

40033501 Kahn, B. (1986) Addenda to Analysis and Certification of Product Ingredients in

Betasan Selective Herbicide: Laboratory Project. ID: RRC-86-88. Unpublished study

prepared by Stauffer Chemical Co. 17 p.

40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data

Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish & Wildlife

Service, Resource Publication 160. 579 p.

40228401 Duplicate of MRID #40098001

40460301 Subba-Rao, R. (1987) Aerobic Metabolism of Bensulide in Soil: Document No.

PMS-219. Unpublished study prepared by ICI Americas, Inc. Western Research

Center. 71 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

86

40460302 Subba-Rao, R. (1987) Anaerobic Metabolism of Bensulide in Soil: Document No.

PMS-220. Unpublished study prepared by ICI Americas, Inc. Western Research

Center. 65 p. 

40513401 Riggs, R. (1988) Bensulide--Aqueous Photolysis Study: Laboratory Project ID: RRC

88-08. Unpublished study prepared by ICI Americas, Inc. 55 p.

40534901 McKay, J. (1987) Betasan (Bensulide) 4-E Field Dissipation Study: Mississippi, 1986:

Laboratory Project ID: 87-115. Unpublished study prepared by Stauffer Chemical

Co. 69 p.

40534902 McKay, J. (1987) Betasan (Bensulide) 4-E Field Dissipation Study: California, 1986:

Laboratory Project ID: 87-109. Unpublished study prepared by Stauffer Chemical

Co. 44 p.

40534903 McKay, J. (1987) Betasan (Bensulide) 12.5-G Field Dissipation Study: Mississippi,

1986: Laboratory Project ID: 87-107. Unpublished study prepared by Stauffer

Chemical Co. 72 p.

40534904 McKay, J. (1987) Betasan (Bensulide) 12.5-G Field Dissipation Study: California,

1986: Laboratory Project ID: 87-108. Unpublished study prepared by Stauffer

Chemical Co. 48 p.

40534905 McKay, J. (1987) Prefar (Bensulide) 4-E Field Dissipation Study: California, 1986:

Laboratory Project ID: 87-112. Unpublished study prepared by Stauffer Chemical

Co. 45 p.

40534906 McKay, J. (1987) Prefar (Bensulide) 4-E Field Dissipation Study: Mississippi, 1986:

Laboratory Project ID: 87-116. Unpublished study prepared by Stauffer Chemical

Co. 57 p. 

41532001 Hillebrecht, W. (1990) Bensulide--Physical Properties: Lab Project Number: RR

90-092B: ENV-022. Unpublished study prepared by ICI Americas, Inc. 30 p.

41597501 Allen, S.; Ishmael, J. (1989) Bensulide: Acute Dermal Toxicity to the Rat: Lab Project

Number: P/2522: CR2585. Unpublished study prepared by ICI Central Toxicology

Laboratory. 27 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

87

41597502 Pemberton, M.; Ishmael, J. (1989) Bensulide: Eye Irritation to the Rabbit: Lab Project

Number: CTL/P/2520: FB4160. Unpublished study prepared by ICI Central

Toxicology Laboratory. 32 p.

41597503 Ott, K. (1989) Bensulide: Storage Stability Study: Crops and Soil: Storage Stability

Validation for Bensulide in Raw Agricultural Commodities and Soil: Lab Project

Number: RR 89-050B. Unpublished study prepared by ICI Americas Inc. 73 p.

41646201 Brammer, A. (1989) Bensulide: 4-Hour Acute Inhalation Toxicity Study on the Rat:

Lab Project Number: CTL/P/2501: HR0867. Unpublished study prepared by ICI

Central Toxicology Lab. 109 p. 

41694201 Iwata, Y. (1990) Betasan: Field Dissipation Study for Terrestrial Uses: Lab Project

Number: RR 89-044B: BETA-88-SD-02. Unpublished study prepared by ICI

Americas, Inc. 108 p.

41694202 Iwata, Y. (1990) Betasan: Field Dissipation Study for Terrestrial Uses: Lab Project

Number: RR 89-008B: BETA-88-SD-01. Unpublished study prepared by ICI

Americas, Inc. 117 p. 

41902601 James, N.; Mackay, J. (1990) Bensulide: An Evaluation in the in vitro Cytogenetic

Assay in Human Lymphocytes: Lab Project Number CTL/P/3198: SV0460. 

Unpublished study prepared by ICI Central Toxicology Lab. 32 p.

41902602 Mackay, J. (1990) Bensulide: An Evaluation in the Mouse Micro-nucleus Test: Lab

Project Number: CTL/P/3173: SM0461. Unpublished study prepared by ICI Central

Toxicology Lab. 34 p.

41931001 Akhaven, M. (1991) The Bioaccumulation of 14C-Bensulide in Bluegill Sunfish: Lab

Project Number: PMS355: RR 91-032B. Unpublished study prepared by ICI

Americas Inc. and Analytical Biochemistry Laboratories, Inc. 91 p.

42007901 Lythgoe, R.; Jones, B. (1991) Bensulide: Repeat Dose Study in the Rat (1mg/kg): Lab

Project Number: CTL/P/3288: UR0339. Unpublished study prepared by ICI Central

Toxicology Lab. 39 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

88

42007902 Lythgoe, R.; Jones, B. (1991) Bensulide: Excretion and Tissue Retention of a Single

Oral Dose in the Rat (100mg/kg): Lab Project Number: CTL/P/3289: UR0345. 

Unpublished study prepared by ICI Central Toxicology Lab. 36 p.

42007903 Lythgoe, R.; Jones, B. (1991) Bensulide: Excretion and Tissue Retention of a Single

Oral Dose in the Rat (1mg/kg): Lab Project Number: CTL/P/3287: UR0338. 

Unpublished study prepared by ICI Central Toxicology Lab. 35 p.

42007904 Jones, B.; McAsey, S.; Soames, A. (1991) Bensulide: Whole Body Autoradiography

Study in the Rat Following a Single Oral Dose (1mg/kg): Lab Project Number:

CTL/P/3286: UR0337. Unpublished study prepared by ICI Central Toxicology Lab. 

24 p.

42103201 Beguhn, M. (1991) Letter Sent to U.S. EPA dated November 22, 1991: [Providing

information on Reflex Herbicide formulation testing]. Prepared by ICI Agricultural

Products. 3 p.

42162001 Ericson, J. (1988) Bensulide: Photolysis on a Soil Surface: Lab Project Number: WRC

88-83: ENV-005. Unpublished study prepared by ICI Americas Inc, Western Res.

Ctr. 36 p.

42162002 Linsey, D.; Leah, A. (1991) Bensulide: 21-Day Dermal Toxicity to the Rat: Lab

Project Number: CTL/P/3285: LR0553. Unpublished study prepared by ICI, Alderley

Park (UK). 292 p.

42225401 Havell, M.; Lappin, G. (1992) Bensulide: Biotransformation in the Rat: Lab Project

Number: CTL/P/3565: URO324. Unpublished study prepared by ICI, Alderley Park. 

55 p.

42281301 Gorder, G.; Steginsky, C.; Allton, J. (1992) Bensulide: Carrot Metabolism: Lab

Project Number: PMS 332: PR 91-096B. Unpublished study prepared by ICI

Americas Inc. 146 p.

42350401 Gorder, G.; Saxena, A.; Marengo, J.; et al. (1992) Bensulide: Tomato Metabolism:

Lab Project Number: PMS 330. Unpublished study prepared by ICI Americas and

Battelle. 117 p.
BIBLIOGRAPHY

MRID CITATION

____________________________________________________

89

42479201 Hillebrecht, W. (1992) Evaluation in the In Vitro Cytogenetic Assay in Human

Lymphocytes (CTL/P/3198): Bensulide: Addendum #1 to MRID # 41902601,

Response to EPA Review Comments: Lab Project No. WHR-91492. Unpublished

study prepared by ICI Americas. 5 p.

42507901 Gorder, G. (1992) Response to EPA Review of Bensulide: Carrot Metabolism (MRID

#42281301): Lab Project Number: PMS 332. Unpublished study prepared by ICI

Americas, Inc. 20 p.

42578001 Gorder, G. (1992) Bensulide: Lettuce Metabolism: Lab Project Number: RR 91-095B:

PMS 331. Unpublished study prepared by ICI Americas, Inc. 127 p.

42578002 Lay, M.; Diaz, D. (1992) Bensulide: Confined Rotational Crop Study: Lab Project

Number: PMS 333: RR 91-081B. Unpublished study prepared by ICI Americas, Inc. 

95 p. 

42685001 Kahn, B. (1993) Product Identity and Disclosure of Ingredients in Betasan Selective

Herbicide: (Addendum to RRC-86-88 and RR 90-258B): Lab Project Number: RR

93-022B. Unpublished study prepared by Western Research Center, Zeneca Inc. 7

p.

42750201 Morrow, J.; Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Sheepshead

Minnow, Cyprinodon variegatus, Under Flow-Through Test Conditions: Lab Project

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42750202 Morrow, J.; Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Eastern

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42750203 Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Mysid, Mysidopsis bahia,

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42864201 Hawk, R. (1992) A Teratology Study in Rabbits with Bensulide ("BETASAN"):

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43121901 Beavers, J.; Trumbull, S.; Grimes, J. et al. (1993) Bensulide Technical: A Pilot

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43121902 Beavers, J.; Trumbull, S.; Grimes, J. et al. (1993) Bensulide Technical: A Pilot

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43180702 Mackie, J.; Hall, B. (1993) The Adsorption and Desorption of (carbon 14)

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43273901 Riach, C.; Willington, S. (1994) Bensulide Mouse Lymphoma Mutation Assay: Lab

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43306301 Beavers, J.; Foster, J.; Mitchell, L. et al. (1994) An Acute Delayed Neurotoxicity

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137 p. 

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43919601 Mulhern, M.; Hudson, P.; Snodgrass, E. (1992) Bensulide: 13 Week Subchronic

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43975701 Kemman, R. (1996) Determination of Three-Year Storage Stability of Bensulide and

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44052701 Dean, I.; Jackson, F. (1994) Bensulide: Oral (Dietary) Maximum Tolerated Dose

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44052702 Dean, I.; Jackson, F. (1993) Bensulide: 4 Week Oral (Dietary) Dose Range Finding

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44052703 Dean, I.; Jackson, F. (1995) Bensulide: 13 Week Oral (Dietary) Toxicity Study in

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44052704 Fisher, K.; Ross, L. (1995) Bensulide: Validation of Analytical Method No. 5497B for

the Analysis of Bensulide in Dog Diet; The Assessment of Diet Mixing Procedures; and

the Stability of Bensulide in Such Formulations: Lab Project Number: 10583: 354973:

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44066401 Smith, D.; Dean, I. (1996) Bensulide 52 Week Oral (Dietary) Chronic Toxicity Study

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44161101 Wilerton, J.; Atkinson, C.; Petersen-Jones, M. (1996) 104 Week Dietary Combined

Chronic Toxicity and Carcinogenicity Study in Rats with 26, 52 and 78 Week Interim

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44161102 Fisher, K.; Martin, J. (1994) Validation of Analytical Method No. 5499 for the

Analysis of Bensulide in Rodent Breeder (Rat and Mouse No. 3) Diet; The Assessment

of Diet Mixing Procedures and the Stability of Bensulide in Such Formulations: Lab

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44161103 Fleck, R.; Fisher, K. (1996) Validation of Analytical Method No. 5494 for the

Analysis of Bensulide in Rodent Dietary Formulations: Lab Project Number: 354947:

9343: 5494. Unpublished study prepared by Inveresk Research. 43 p.

44161104 Mulhern, M.; Finch, J. (1993) 13 Week Dietary Dose Range Finding Study in Mice:

Lab Project Number: 451052: 7950: IRI 451052. Unpublished study prepared by

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Carcinogenicity Study in Mice with 52 Week Interim Kill: Bensulide: Lab Project

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44206301 Fisher, K.; Brown, I. (1997) Establishment of Methodology for the Analysis of

Bensulide in Rodent Diet; the Assessment of Diet Mixing Procedures and the Stability

of Bensulide in Such Formulations: Lab Project Number: 354947: 12058: 5494B. 

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44223801 Gorder, G. (1997) Bensulide: Tomato Metabolism: Storage Data: Addendum 1: Lab

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44297001 Kemman, R. (1997) Prefar 4-E (Bensulide) Herbicide Field Soil Dissipation Study

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GOWN-9319: BENS-91-SD-03. Unpublished study prepared by Compliance

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44486901 Mansell, P. (1998) Bensulide Technical: Reproduction in the Mallard Duck: Lab

Project Number: GWN 3: GWN 3/971413. Unpublished study prepared by

Huntingdon Life Sciences Ltd. 202 p.

44720402 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test for Determining the Effects of

Test Substances to the Green Alga, Selenastrum capricornutum (Bensulide Technical):

Lab Project Number: 44601. Unpublished study prepared by ABC Laboratories, Inc. 

30 p.

44720403 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test for Determining the Effects of

Test Substances to the Blue-Green Alga, Anabaena flos-aquae (Bensulide Technical):

Lab Project Number: 44602. Unpublished study prepared by ABC Laboratories, Inc. 

29 p.

44720404 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test for Determining the Effects of

Test Substances to the Freshwater Diatom, Navicula pelliculosa: (Bensulide Technical):

Lab Project Number: 44603. Unpublished study prepared by ABC Laboratories, Inc. 

30 p.

44720405 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test for Determining the Effects of

Test Substances to the Saltwater Diatom, Skeletonema costatum: (Bensulide

Technical): Lab Project Number: 44604. Unpublished study prepared by ABC

Laboratories, Inc. 30 p.

44720406 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test for Determining the Effects of

Test Substances to Duckweed, Lemna gibba G3 (Bensulide Technical): Lab Project

Number: 44605. Unpublished study prepared by ABC Laboratories, Inc. 29 p.

44720407 Kranzfelder, J.; Stuerman, L.; Malorin, D. (1998) Life Cycle Toxcity Test of Daphnia

magna Under Flow-Through Conditions (Bensulide Technical): Lab Project Number:

44606. Unpublished study prepared by ABC Laboratories, Inc. 42 p. 
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44720408 Kranzfelder, J.; Stuerman, L.; Malorin, D. (1998) Early Life-Stage Toxicity Test of

Fathead Minnow, Pimephales Promelas Under Flow-Through Conditions (Bensulide

Technical): Lab Project Number: 44607. Unpublished study prepared by ABC

Laboratories, Inc. 42 p.

44799001 Gouker, E. (1999) Determination of Transferable and Total Turf Residues on Turf

Treated with Bensulide: Lab Project Number: 98703: 44679. Unpublished study

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44801101 Killeen, J.; Benz, G.; Eland, W. et al. (1999) A 21-Day Repeated Dose Dermal

Toxicity Study in Rats with Technical Bensulide: Establishing a No Effect Level for

Cholinesterase Inhibition: Lab Project Number: 7714-99-0002-TX-001:

7713-98-0210-TX-001: 007714-99-0002-TX-00. Unpublished study prepared by

Ricerca, Inc. 181 p.

44809401 Killeen, J.; Benz, G.; Eland, W. et al. (1999) A 21-Day Repeated Dose Dermal

Toxicity Study in Rats with Technical Bensulide: Establishing a No Effect Level for

Cholinesterase Inhibition: Lab Project Number: 7714-99-0002-TX-001:

007714-99-0002-TX-000. Unpublished study prepared by Ricerca, Inc. 181 p.

{OPPTS 870.3200}

92005011 McCall, J. (1990) Ici Americas Inc. Phase 3 Summary of MRID 00097921. 

Bensulide (Betasan): Acute Oral Toxicity to the Rat: CTL Report No. T-6389. 

Prepared by Stauffer Chemical Company. 7 p.

92005012 Parr-Dobrzanski, R. (1990) Ici Americas Inc. Phase 3 Summary of MRID 00097921. 

Bensulide (Betasan): Skin Irritation to the Rabbit: Report No. T-6389. Prepared by

Stauffer Chemical Company. 6 p.

92005033 Adelson, B.; McKay, J. (1990) Ici Americas Inc. Phase 3 Summary of MRID

00120235 and Related MRIDs 00045415. Bensulide Magnitude of the Residue on

Peppers: Laboratory Study ID No. RR 90-309B. Prepared by ICI Americas Inc. 8 p.

92005034 Adelson, B.; McKay, J. (1990) Ici Americas Inc. Phase 3 Summary of MRID

00028822 and Related MRIDs 00120235, 00045415, 00028828. Bensulide

Magnitude of the Residue on Tomatoes: Laboratory Study ID No. RR 90-268B. 

Prepared by ICI Americas Inc. 9 p.
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92005035 Adelson, B.; McKay, J. (1990) Ici Americas Inc. Phase 3 Summary of MRID

00116016 and Related MRIDs 00028828. Bensulide Magnitude of the Residue on

Carrots: Laboratory Study ID No. RR 90-318B. Prepared by ICI Americas Inc. 8 p.

92005036 Iwata, Y. (1990) ICI Americas Inc. Phase 3 Reformat of MRID 00028828 and

Related MRIDs 00121001. Betasan/Prefar Residue Analytical Method: Laboratory

Study ID No. RR 90-203B. Prepared by ICI Americas Inc. 24 p. 

92005037 Adelson, B.; McKay, J. (1990) ICI Americas Inc. Phase 3 Reformat of MRID

00028820 and Related MRIDs 00029526, 00028828, 00045415. Bensulide

Magnitude of the Residue on Cucumbers: Lab Study ID No. RR 90-324B. Prepared

by Stauffer Chemical Company. 55 p.

92005038 Adelson, B.; McKay, J. (1990) ICI Americas Inc. Phase 3 Reformat of MRID

00029526 and Related MRIDs 00028820, 00028828. Bensulide Magnitude of the

Residue on Melons: Laboratory Study ID No. RR 90-312B. Prepared by ICI

Americas, Inc. 52 p. 

92005039 Adelson, B.; McKay, J. (1990) ICI Americas Inc. Phase 3 Reformat of MRID

00028820 and Related MRIDs 00034891, 00028828, 00045415. Bensulide

Magnitude of the Residue on Squash: Lab. Study ID No. RR 90-321B. Prepared by

ICI Americas Western Research Center. 64 p.

92005040 Adelson, B.; McKay, J. (1990) ICI Americas Inc. Phase 3 Reformat of MRID

00120235 and Related MRIDs 00045415. Bensulide Magnitude of the Residue on

Peppers: Laboratory Study ID No. RR 90-310B. Prepared by ICI Americas, Inc. 40

p.

92005041 Adelson, B.; McKay, J. (1990) ICI Americas Inc. Phase 3 Reformat of MRID

00028822 and Related MRIDs 00120325, 00045415, 00028828. Bensulide

Magnitude of the Residue on Tomatoes: Lab. Study ID No. RR 90-269B. 111 p.

Studies without MRID Numbers

Atkins, E.L., Jr., L.D. Anderson, and E.A. Greywood. 1969. Effects of pesticides on

apiculture: Project No. 1499, Research report CF-7501.
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Agriculture. Austin, TX. 

Barrett, M. to Merenda, J. 30 June 1997. Proposal for Method to Determine

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Sources. USEPA, Office of Pesticide Programs, Washington, D.C.

Bellrose, F.C. 1980. Ducks, Geese, and Swans of North America. 3rd ed. 

Stackpole Books, Harrisburg, PA. 540 pp.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and

evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for estimating

pesticide residues on plants. Environ. Toxicol. Chem. Vol.13: pp.1383-1391.

Heath, R.G., J.W. Spann, and J.F. Kreitzer. 1969. Marked DDE impairment of

mallard reproduction in controlled studies. Nature (Lond.). Vol. 224: pp. 47-48.

Hoerger, F. and E.E. Kenaga. 1972. Pesticide residues on plants: correlation of

representative data as a basis for estimation of their magnitude in the environment.

Environmental Quality and Safety. Vol. 1: pp. 9-28.

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and providing bensulide usage data. Washington, D.C.

Gowan, 1997b. Notes from presentation by Gowan Company at meeting with

USEPA, Office of Pesticide Programs, 13 May, 1997. Washington, D.C. 

Niemczyk, H.D. and A.A. Krause. 1994. Behaviour and mobility of preemergent

herbicides in turfgrass: a field study. J. Environ. Sci. Health B29: 507-539.

Meister, 1995. Farm Chemicals Handbook '95. Meister Publishing Co., Willoughby,

OH. 

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selected herbicides to fingerling channel catfish, Ictalurus punctatus. Bull. Environ.

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subacute toxicity study of N-(2-mercaptoethyl) benzenesulfonamide S-(O,Odiisopropyl phosphorodithioate) and phthalimidomethyl-O,O-dimethyl

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Decision to Ban Its Use as a Pesticide. U.S. Environmental Protection Agency. EPA540/1-75-022. Washington, D.C.

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101

Appendix E. GENERIC DATA CALL-IN

See attached table for a list of generic data requirements. Note that a complete Data Call-In

(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
102
103

Requirements Status and Registrant’s RESPONSE Page 1 of 1
104

 Comments for Guideline Requirements PAGE 1 of 1
105

Appendix F. PRODUCT SPECIFIC DATA CALL-IN

See attached table for a list of product-specific data requirements. Note that a complete Data

Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
106
107

Product Specific DATA CALL-IN RESPONSE page 1 of 1
108

Product Specific REQUIREMENTS STATUS AND REGISTRANT’S

RESPONSE page 1 of 2
109

Requirements Status And Registrant's Response Page 2 of 2
110

Product Specific Footnotes and Key Definitions for Guideline Requirements 

Page 1 of 2
111

Product Specific Footnotes and Key Definitions for Guideline Requirements Page 2 of 2 
112
113

Appendix G. EPA’S BATCHING OF BENSULIDE PRODUCTS FOR MEETING

ACUTE TOXICITY DATA REQUIREMENTS FOR

REREGISTRATION

In an effort to reduce the time, resources and number of animals needed to fulfill the acute

toxicity data requirements for reregistration of products containing bensulide as the active ingredient, the

Agency has batched products which can be considered similar for purposes of acute toxicity. Factors

considered in the sorting process include each product's active and inert ingredients (identity, percent

composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,

wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary

labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since

some products within a batch may not be considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the process described in the

preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at

any time, acute toxicity data for an individual product should the need arise. 

Registrants of products within a batch may choose to cooperatively generate, submit or cite a

single battery of six acute toxicological studies to represent all the products within that batch. It is the

registrants' option to participate in the process with all other registrants, only some of the other

registrants, or only their own products within a batch, or to generate all the required acute toxicological

studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she

must use one of the products within the batch as the test material. If a registrant chooses to rely upon

previously submitted acute toxicity data, he/she may do so provided that the data base is complete and

valid by today's standards (see acceptance criteria attached), the formulation tested is considered by

EPA to be similar for acute toxicity, and the formulation has not been significantly altered since

submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or

existing data is referenced, registrants must clearly identify the test material by EPA Registration

Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant

must indicate the formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements, registrants must follow the

directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice

contains two response forms which are to be completed and submitted to the Agency within 90 days of

receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data

requirements for each product. The second form, "Requirements Status and Registrant's Response,"

lists the product specific data required for each product, including the standard six acute toxicity tests. 

A registrant who wishes to participate in a batch must decide whether he/she will provide the data or

depend on someone else to do so. If a registrant supplies the data to support a batch of products,

he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing

Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
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registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to

Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to

participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that

choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her

studies and offering to cost share (Option 3) those studies.

Forty five products were found which contain bensulide as the active ingredient. These

products have been placed into seven batches and a "no batch" category in accordance with the active

and inert ingredients and type of formulation. The following bridging strategies may be employed:

• Batch 2 may cite Batch 1 with the exception of eye and skin irritation data

• Batch 5 may rely on Batch 4 data

• Batches 6 and 7 may use the policy for granular pesticide products. However, due to the

differences in inerts in Batch 6, products within Batch 6 may not share eye irritation data. 

 

NOTE: The technical acute toxicity values included in this document are for informational purposes

only. The data supporting these values may or may not meet the current acceptance criteria.

 Batch EPA Reg. No. % Active Ingredient Formulation Type

 1 10163-202 Bensulide...46.0% liquid

2217-777 Bensulide...46.0% liquid

34704-211 Bensulide...46.0% liquid

769-895 Bensulide...46.0% liquid

961-336 Bensulide...46.0% liquid

 Batch EPA Reg. No. % Active Ingredient Formulation Type

 2 10163-196 Bensulide...46.0% liquid

10163-200 Bensulide...46.0% liquid

10163-205 Bensulide...46.0% liquid

2217-696 Bensulide...46.0% liquid

56076-3 Bensulide...46.0% liquid
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 Batch EPA Reg. No. % Active Ingredient Formulation Type

 3 10163-197 Bensulide...34.8% liquid

 33955-554 Bensulide...34.8% liquid

5887-135 Bensulide...34.8% liquid

8660-128 Bensulide...34.8% liquid

 Batch EPA Reg. No. % Active Ingredient Formulation Type

4 10163-198 Bensulide...12.5% liquid

 34704-209 Bensulide...12.5% liquid

769-894 Bensulide...12.5% liquid

538-11 Bensulide...11.0% liquid

 Batch EPA Reg. No. % Active Ingredient Formulation Type

5 538-26 Bensulide...8.5% solid

10163-204 Bensulide...7.0% solid

34704-208 Bensulide...7.0% solid

769-896 Bensulide...7.0% solid

8660-127 Bensulide...7.0% solid

961-338 Bensulide...7.0% solid
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 Batch EPA Reg. No. % Active Ingredient Formulation Type

6* 538-129 Bensulide...5.2% solid

538-155 Bensulide...4.78% solid

 538-53 Bensulide...4.6% solid

9198-73 Bensulide...4.6% solid

34704-216 Bensulide...3.6% solid

9198-72 Bensulide...3.6% solid

961-337 Bensulide...3.6% solid

538-156 Bensulide...3.58% solid

3234-36 Bensulide...3.28% solid

*Batch 6 products may not share eye irritation data.

 Batch EPA Reg. No. % Active Ingredient Formulation Type

7 10163-199 Bensulide...3.6% solid

32802-15 Bensulide...3.6% solid

 34704-210 Bensulide...3.6% solid

769-897 Bensulide...3.6% solid

869-212 Bensulide...3.6% solid
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No

Batch

EPA Reg. No. % Active Ingredient Formulation Type

10163-201 Bensulide...92.0% liquid

10163-222 Bensulide...63.5% liquid

 2217-778 Bensulide...7.0% solid

538-164 Bensulide...5.25% solid

538-77 Bensulide...5.1% solid

 8660-126 Bensulide...3.6% solid

10163-203 Bensulide...3.6% solid
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119

Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN
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Insert List–Page 1 of 1
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Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND

ELECTRONICALLY AVAILABLE FORMS

Pesticide Registration Forms are available at the following EPA internet

site:

http://www.epa.gov/opprd001/forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) 

Instructions

1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled

out on your computer then printed.)

2. The completed form(s) should be submitted in hardcopy in accord with the existing

policy. 

 3. Mail the forms, along with any additional documents necessary to comply with EPA

regulations covering your request, to the address below for the Document Processing

Desk.

 DO NOT fax or e-mail any form containing 'Confidential Business Information' or

'Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole Williams at

(703) 308-5551 or by e-mail at williams.nicole@epamail.epa.gov.

The following Agency Pesticide Registration Forms are currently available via the internet:

at the following locations:

8570-1 Application for Pesticide

Registration/Amendment

http://www.epa.gov/opprd001/forms/8570-1.pdf.

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf.

8570-5 Notice of Supplemental Registration of

Distribution of a Registered Pesticide

Product 

http://www.epa.gov/opprd001/forms/8570-5.pdf.

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf.

8570-25 Application for/Notification of State

Registration of a Pesticide To Meet a Special

Local Need 

http://www.epa.gov/opprd001/forms/8570-25.pdf.

8570-27 Formulator's Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf.
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8570-28 Certification of Compliance with Data Gap

Procedures 

http://www.epa.gov/opprd001/forms/8570-28.pdf.

8570-30 Pesticide Registration Maintenance Fee

Filing 

http://www.epa.gov/opprd001/forms/8570-30.pdf.

8570-32 Certification of Attempt to Enter into an

Agreement with other Registrants for

Development of Data 

http://www.epa.gov/opprd001/forms/8570-32.pdf.

8570-34 Certification with Respect to Citations of

Data (in PR Notice 98-5)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf.

8570-35 Data Matrix (in PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf.

8570-36 Summary of the Physical/Chemical

Properties (in PR Notice 98-1)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf.

8570-37 Self-Certification Statement for the

Physical/Chemical Properties (in PR Notice

98-1)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf.

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.
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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

b. Biopesticides and Pollution Prevention Division (BPPD) Contacts

c. Antimicrobials Division Organizational Structure/Contact List 

d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements

(PDF format)

e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF

format) 

f. 40 CFR Part 158, Data Requirements for Registration (PDF format) 

g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985) 

Before submitting your application for registration, you may wish to consult some additional

sources of information. These include: 

1. The Office of Pesticide Programs' 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. 
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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 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.

Documents Associated with this RED 

The following documents are part of the Administrative Record for this RED document and may

included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not

available electronically, but may be obtained by contacting the person listed on the respective Chemical

Status Sheet.

a. Health and Environmental Effects Science Chapters.

b. Detailed Label Usage Information System (LUIS) Report.