xvEPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA 738-F-00-001
June 2000
Interim Reregistration
Eligibility Decision (IRED)
Bensulide
y S PPA Headquarters Library
Mai'-wio-3201
1200 P=nr*«'A"Hru& Avenue NW
Washington DC 20460
-------
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-00-001
June 2000
Bensulide Facts
EPA has assessed the risks of bensulide and reached an Interim Reregjstration Eligibility
Decision (ERED) for this organophosphate (OP) pesticide. With the risk mitigation measures required,
bensulide fits into its own "risk cup"- its individual, aggregate risks are within acceptable levels.
Bensulide also is eligible for reregistration, pending a full reassessment of the cumulative risk from all
OPs.
Bensulide residues in food and drinking
water do not pose risk concerns. With
mitigation limiting homeowners' and children's
exposure via home lawns and other turf,
bensulide fits into its own "risk cup." With
other mitigation measures, bensulide's worker
and ecological risks also will be below levels of
concern for reregistration.
EPA's next step under the Food Quality
Protection Act (FQPA) is to complete a
cumulative risk assessment and risk
management decision encompassing all the OP
pesticides, which share a common mechanism
of toxicity. The interim decision on bensulide
cannot be considered final until mis cumulative
assessment is complete. Further risk mitigation
may be required at that time.
EPA is reviewing the OP pesticides to
determine whether they meet current health and
safety standards. Older OPs need decisions
about their eligibility for reregistration under
FIFRA. OPs with residues in food, drinking water, and other non-occupational exposures also must be
reassessed to make sure they meet the new FQPA safety standard.
The bensulide interim decision was made through the OP pilot public participation process,
which increases transparency and maximizes stakeholder involvement in EPA's development of risk
The OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality Protection
Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
U.S. EPA Headquarters Library
Mail code 3201
1200 Pennsylvania Avenue NW
Washington DC 20460
-------
assessments and risk management decisions. EPA worked extensively with affected parties to reach
the decisions presented in this interim decision document, which concludes the OP pilot process for
bensulide.
Uses
• An herbicide, bensulide is used to control a variety of grasses and weeds in food crops (60 to
65 % of all use) including carrots, fruiting vegetables, leafy vegetables (mostly head lettuce),
dry bulb vegetables (onions), cucurbits (mostly melons), and cole crops (cauliflower, cabbage,
broccolini and broccoflower). Bensulide products may be used outdoors by homeowners on
lawns and ornamentals, and by professional lawn care operators. Bensulide may be used on
turf (primarily golf course greens and tees), on ornamentals, and for greenhouse and outdoor
uses in commercial nurseries.
Annual domestic use is low- approximately 550,000 pounds of active ingredient per year.
Health Effects
Bensulide can cause cholinesterase inhibition in humans; that is, it can overstimulate the nervous
system causing nausea, dizziness, confusion, and at very high exposures (e.g., accidents or
major spills), respiratory paralysis and death.
Risks
Dietary exposures from eating food crops treated with bensulide are below the level of concern
for the entire U.S. population, including infants and children. Drinking water is not a significant
source of exposure.
Risks are of concern for homeowners who apply bensulide, and for children entering turf areas
treated with bensulide if label directions are not followed properly.
EPA also has risk concerns for workers who mix, load, and/or apply bensulide to agricultural
sites, golf courses, and home lawns.
Chronic risks are of concern for birds and mammals; risks are posed to some aquatic species.
-------
Risk Mitigation
To mitigate risks to agricultural workers:
• for groundboom application, add respirators for mixers and/or loaders; add personal
protective equipment or use of closed systems for commercial applicators;
• for chemigation, require respirators for mixing and/or loading; and restrict this
application to California and Arizona where acreage treated is low.
To mitigate worker risks from turf use:
prohibit all handheld application methods except one (retained for spot treatment only);
prohibit treatment of large turf areas like parks and recreation areas, except golf
courses (see restrictions below for golf courses) (this measure will also reduce risks to
children and the environment);
require respirators and gloves for all remaining mixer/loader turf uses;
• require respirators for all "for hire" applications;
• require coveralls, gloves, and a respirator for application of granulars with a push
spreader.
To mitigate residential risks:
• add label language prohibiting use of any handheld application method;
* add label language directing homeowners to water in the herbicide immediately after
application, for safety reasons; and
* prohibit treatment of large turf areas, as mentioned above.
To mitigate ecological risks:
• prohibit use on large non-golf course turf sites (as mentioned above);
• restrict golf course fairway use to a single grass type (bentgrass) in certain states;
• restrict the number of fairway applications to one; and
• limit the fairway application to the fall (minimizing exposure to birds during breeding
season).
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed The Bensulide IRED therefore is issued in final (see www.epa.gov/REDs/ or
www.epa.gov/pesricides/Qp ), without a formal public comment period. The docket remains
open, however, and any comments submitted in the future will be placed in this public docket.
To effect risk mitigation as quickly as possible, time frames for making die changes required by
the Bensulide IRED are shorter than those in a usual RED. The Agency is requiring that all
-------
labels must be amended to include the above mitigation and submitted to the Agency within 90
days after issuance of this ERED.
When the cumulative risk assessment for all organophosphate pesticides is completed, EPA will
issue its final tolerance reassessment decision for bensulide and may require further risk
mitigation measures. The Agency will revoke the cottonseed tolerance because there are no
registered uses, amend a carrot tolerance, and make administrative changes to commodity
definitions now. For all OPs, raising and/or establishing tolerances will be considered once a
cumulative assessment is completed.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
JUL 1 1 2000
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 reregisteation 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 Disrupter 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
VH. 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 (BD3LIOGRAPHY) 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 TOXICrTY DATA REQWREMENTS
FOR REREGISTRATION 113
Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN 119
Appendix I. LIST OF AVARABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 121
-------
-------
BENSULIDE TEAM
Office of Pesticide Programs:
Healtfa Effects Risk Assessment
Kit Harwell
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 Toinpkins
Risk Management
Loan Phan
Jacqueline McQueen
U.S. EPA Headquarters Library
. Mai! code 3201
1200 PenrKv/ivar.ia Avenue NW
Washington DC 20460
-------
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific
(i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects
are not anticipated to occur.
D WLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
111
-------
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/1, mg/kg or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPAs 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
IV
-------
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
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier H Surface Water Computer Model
Q, * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reiegistration 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
-------
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
ug/g Micrograms Per Gram
ug/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 (RID),
VI
-------
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
Ibs 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,
1
-------
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 R.j-'jk- 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 beasulide 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.
-------
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.
Ecologic^ Rjs,k
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
-------
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 FEFRA 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
-------
TRAC identified the following science policy issues it believed were key to the implementation of FQPA
and tolerance reassessment:
Applying the FQPA 10-Fold Safety Factor
Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
Refining Dietary (Food) Exposure Estimates
Refining Dietary (Drinking Water) Exposure Estimates
Assessing Residential Exposure
Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with
a Common Mechanism of Toxicity
Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and in a
different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency 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 n provides a profile of the use and usage of the chemical. Section ID
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 FV. Section VI provides information on how to access related
documents. Finally, the Appendices lists Data Call-in (DCI) information. The revised risk assessments
-------
and related addenda are not included in this document, but are available on the Agency's web page
www.epa.gov/pesticides/op, and in the Public Docket.
II. CHEMICAL OVERVIEW
A. Regulatory History
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:
o
'S / OCH(CH-),
OCH(CHj)2 '
* Common Name:
• Bensulide:
• Chemical family:
• Case number:
• CAS registry number:
• OPP chemical code:
• Empirical formula:
• Molecular weight:
Bensulide
[S-(O,O-diisopropyl phosphorodithioate) ester of N-(2-
mercapto)benzenesulfonamide]
Organophosphate
2035
741-58-2
009801
C14H24N04PS3
397.5
-------
Trade and other names:
Basic manufacturer:
Prefar® 4-E; Prefar® 6-E; Bensumec® 4-LF; Pre-
San® Granular 7G & 12.5G; Betasan® 4-E, 3G
&12.5G
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;
bamyardgrass; 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.
-------
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 Ibs ai/acre, and the 6 Ib rate is often used.
In the southwest deserts, may be applied twice per year at up to 6 Ibs/acre, for a
maximum of 12 Ibs ai/acre/year. The ornamental use for field grown plants and
bulbs is applied at rates up to 9 Ibs 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 Ibs ai/acre per application, applied twice
per year, for a maximum of 25 Ibs 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 Ibs a.i. of bensulide are used
annually, according to Agency and registrant estimates.
-------
Table 1. Bensulide Estimated Usagejor Representative Sites
Crop
Cantaloupes
Carrots
Celery
Cole Crops (broccoli, cabbage, cauliflower)
Cucumbers (fresh and process)
Honeydew
Lettuce
Onions
Peppers (bell, hot, and sweet)
Pumpkins
Squash
Watermelons
Golf Courses
Lawn Care Operators (including residential
and landscape)
Lawn, Homeowners
Public/Go ve rnmen t
Field grown herbaceous plants and bulbs
Lbs. Active
Ingredient Applied
(Wt. Avg.)1
36,000
9,000
6,000
37.000
33.000
16,000
67,000
99,000
32,000
6,000
12,000
12,000
68,000
20,000
<100,000
1,000
< 1,800
Percent Crop
Treated (Likely
Maximum)
24%
3%
13%
10%
9%
34%
19%
23%
12%
35%
38%
9%
<2%
<1%
<2%
unknown
unknown
Percent Crop
Treated (Wt.
Avg.)
22%
2%
4%
5%
6%
18%
7%
11%
4%
19%
25%
5%
<2%
<1 %
<2%
unknown
unknown
1 Weighted Average is based on data for 1987-1996: the most recent years and more reliable data are weighted more
heavily.
in. 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.
-------
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 post-
application occupational and residential risks.
- Use of separate lexicological 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 bensulide-
treated 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.
10
-------
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 IX. 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 RID = 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 (DEEM™). 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.
11
-------
Table 2. Summary of lexicological Endpoints and Other Factors Used in the Human Dietary
Risk Assessment of Bensulide
Assessment
Acute
Dietary
Chronic
Dietary
Dose
NOAEL =
15
mg/kg/day
NOAEL =
0.5
mg/kg/day
Endpoint
Plasma ChE
inhibition
Plasma, brain
ChE
inhibition,
decreased
body weight
gain
Study
Acute rat
neurotoxicity
(MRID
43195901)
Chronic oral
dog (MRIDs
44066401,
44052704)
UF
100
100
FQPA
Safety
Factor
IX
IX
PAD
0.15
mg/kg/day
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 withbensulide-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.
12
-------
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
n 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 FV of this document.
b.
Ground Water
Bensulide is not expected to leach to ground water because its high soil sorption affinity indicates
that it wi]] bind to soil organic matter. A Tier I screening model, SCI-GROW. was used to estimate
13
-------
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 die 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
U S
Population
Females
13-19
Children
1-6
Acute PAD
(mg/kg/day)
0.15
0.15
0.15
Food
Exposure
(rag/kg/day
0.000059
0.000060
0.000122
Allowable
Water
Exposure
(mg/kg/day)
0.149941
0.14994
0.149878
Ground
Water1
(SC1-
GROW)
0.5/1.0
0.5/1.0
0.5/1.0
Surface
Water'
(ppb)
(GENEEC)
106/189
106/189
106/189
Surface
Water
(ppb)'
(PRZM-
EXAMS)
165
165
165
DWLOC
(ppb)
5248
4498
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.
: 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.
14
-------
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 n 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.
15
-------
Table 4. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S.
Population
Females
(13+,
nursing)
Non-
nursing
Infants
(<1 yr)
Chronic
PAD
(mg/kg/day)
0.005
0.005
0.005
Food
Exposure
(mg/kg/day)
0.000015
0.000019
0.000039
Allowable
Water
Exposure
(mgAg/day)
0.004985
0.004981
0.004961
Ground
Water
(ppb)1
0.5/1.0
05/1.0
0.5/1.0
Surface
Water
(ppb)'-'
(GENEEC)
19/34
19/34
19/34
Surface
Water
(ppb)'
(PRZM-
EXAMS)
158
158
158
DWLOC
174
150
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.
: t
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 lexicological endpoints, and other factors used in the occupational and
residential risk assessments for bensulide are listed below.
16
-------
Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational and Residential Risk Assessments for Bensulide
Assessment
Short-term
dermal
Intermediate-
term dermal
Short-term
inhalation
Intermediate -
term inhalation
Non-dietary
ingestion
(children)
Dose
NOAEL = 50
mg/kg/day
NOAEL - 50
mg/kg/day
Oral NOAEL=
5.5 mg/kg/day
Oral NOAEL=
0.5 mg/kg/day
NOAEL = 15
mg/kg/day
Endpoint
Plasma, brain
ChE inhibition
Plasma, brain
ChE inhibition
maternal plasma
ChE inhibition
plasma ChE
inhibition,
decreased body
weight gain.
Plasma ChE
Study
21 -day dermal rat
(MRIDs 44801 101,
44809401)
21 -day dermal rat
(MRIDs 4480 1 101,
44809401)
developmental oral rat
(MRID 00146585)
chronic oral dog
(MRIDs 44066401,
44052704)
acute rat neurotoxicity
(MRID 43 195901)
Absorption
factor
N/A
N/A
100%
100%
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
17
U.S. EPA headquarters Library
Mat! code 3201
1200 Pennsylvania Avenue NW
Washington DC 20460
-------
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:
Label:
Minimum PPE:
Maximum PPE:
Engineering controls:
Long-sleeved shirt and long pants, shoes and socks.
Long-sleeved shirt, long pants, shoes, socks, chemical resistent
gloves.
Baseline + chemical resistant gloves and a respirator.
Baseline •+ coveralls, chemical resistant gloves, and a respirator.
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, short-
term 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.
18
-------
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
19
-------
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:
(la) mixing/loading (M/L) liquids for chemigation application (350 acres, 40 acres);
(Ib) 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
Ibs 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.
20
-------
Table 6. Agricultural Uses: Remaining Risk Concerns (combined dermal & inhalation MOEs)
Scenario
(la) M/L liquids for
chemigation
(Ib) M/L liquids for
groundboom appl.
Acres
350
350
40
40
SO
80
Rate
3
6
3
6
3
6
Short-term MOE
Baseline'
1
<1
10
5
5
2.5
Current
Label2
98
49
860
430
430
215
Current label -
respirator
138
69
1210
605
605
302
Engineering Controls
356
178
3118
1559
1559
780
Long pants, long sleeve shirt, shoes, socks
' Long sleeve shirt, long pants, shoes, socks, chemical resistant gloves
Scenario
(la) M/L liquids for
chemigation
(Ib) M/L liquids for
groundboom appl.
(3) A/ sprays with
groundboom
Acres
350
350
40
40
80
80
80
Rate
3
6
3
6
3
6
6
Intermediate-term MOE
Baseline'
1
<1
10
5
5
2
83
Current
Label2
23
12
204
102
102
51
83 ""
Current label •+•
respirator
95
48
833
417
417
208
341
Engineering Controls
•'** •
197
99
1726
863
863
432
784
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
21
-------
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 short-
term 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:
(Ib) M/L liquids for groundboom application (40 acres);
(1 c) 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 andpoa 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
22
-------
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)
Scenario
(Ib) M/L liquids for
groundboom appl.
(Ic) M/L liquids for
professional turf appl.
(5) M/L/A w/low pressure
hand wand
(6) M/L/A w/high pressure
hand wand
(7) M/L/A w/backpack
sprayer
(8) M/L/A with low
pressure/high volume
turfgun
Acres
40
40
50
50
5
5
7
7
1000
gal.
5
5
7
7
5
5
7
7
Rate
7.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
0.16
7.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
Short-term MOEs
Baseline'
4
2
3
2
<1
<1
<1
<1
No data
No data
No data
No data
No data
25
15
18
11
Current
label2
344
206
275
165
133
80
95
57
6
34
20
24
14
243
146
174
104
Current label +
respirator
484
291
387
232
204
122
146
88
8
37
22
26
16
258
154
184
no
Engineering
controls
124782
748
998
599
NF3
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
23
-------
Scenario
(9) Loading and applying
w/push-type granular
spreader
(10) Loading and applying
with hand held rotary
spreader
Acres
5
5
5
5
Rate
7.5
12.5
7.5
12.5
Short-term MOEs
Baseline'
32
19
9
5
Current
label2
70
42
10
6
Current label +
respirator
73
44
15
9
Engineering
controls
NF
NF
NF
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
Scenario
(Ib) M/L liquids for
groundboom appl.
(Ic) M/L liquids for
professional turf appl.
(2) L/ granulars for
tractor-drawn spreader
appl.
(3) A/sprays with
groundboom sprayer
(4) A/ granulars with
tractor-drawn spreader
(5) M/L/ A with low
pressure handwand
(6) M/L/ A with high
pressure handwand
Acres
40
40
50
50
40
40
40
40
40
5
5
7
7
1000 gal
Rate
7.5
12.5
7.5
12.5
7.5
12.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
0.16
Intermediate-term MOEs
Baseline1
4
2
3
2
65
39
80
90.
54
<1
-------
Scenario
(7) Backpack sprayer
(8) Low pressure/high
volume turfgun
(9) Loading and applying
with push-type granular
spreader
(10) Loading and applying
with hand-held rotary
spreader
Acres
5
5
7
7
5
5
7
7
5
5
5
5
Rate
7.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
7.5
12.5
Intennediate-term MOEs
Baseline1
No data
No data
No data
No data
24
14
17
10
26
16
6
4
Current
label*
17
10
12
7
150
90
108
64
49
30
6
4
Current label +
respirator
33
20
24
14
242
145
173
104
70*
42*
.9
6
Engineering
controls
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
1 Long-sleeve shirt, long pants, shoes, socks
: Long-sleeve shin, 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 (USD A) has indicated that, in most transplanting
25
-------
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 Ibs 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.
26
-------
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
(10) L/A with hand-held rotary
method
Acres
0.5
0.5
Rate
7.5
12.5
Shon-Term MOE
S
5
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
27
-------
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 IE. 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.
28
-------
Table 9. Drinking Water Levels of Comparison for Short-term Aggregate Exposure
Population
Homeowners Who Apply
(General Pop. Handlers)
Yard work (General Pop.,
Heavy Activity)
Golfers (General Pop.,
Light Activity)
Toddlers
Total MOE
for Non-
Water
Exposures
183
482
8,257
236
Ground Water
(ppb)'
(SC1-GROW)
0.5/1.0
0.5/1.0
0.5/1.0
05/1.0
Surface Water
PPM2"1
(GENEEO
19/34
19/34
19/34
19/34
Surface Water
(ppb)'
(PRZM-EXAMS}
158
158
158
158
DWLOC
(ppb)
2,388
4,160
5.186
863
The value of 0.5 ppb is with 1 turf application/year, the 1.0 ppb value is with 2 turf applications/year.
" The value of 19 ppb is with 1 turf applicatiorvyear, 34 ppb is with 2 turf applications/year
J The value of 158 ppb is with broadcast vegetable application.
* 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 RED 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 iully 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."
include:
Several revisions have been made since the preliminary risk assessment was completed, and
- 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.
29
-------
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 (K^s ranged from 1,433 to 4,326 ml/g); however, the degradates bensulide oxon (N-[(2-
(diisopropoxyphosphinoylthio)-l-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 Ib 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 Ibs ai/acre each
on turf sites). This risk is of greater concern on large turf areas, where water fowl are attracted and
30
-------
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.
31
-------
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 Ibs 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.
32
-------
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 die 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.
-------
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
34
-------
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 psise 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*, ppm'
Tolerances Listed Under 40 CFR §180.241
Carrots
Cottonseed
Cucurbits
0.10
0.10
0.10
0.10
Revoke
0.15
Comment/
[Correct Commodity Definition]
This tolerance must be modified to
one with regional registration (TX).
Also, labels must be amended to
reflect a maximum seasonal use rate
of5tb/A.
There are currently no registered
uses of bensulide on cotton.
[Cucurbit Vegetables Group]
35
-------
Commodity
Fruiting Vegetables3
Leafy vegetables
Onions (dry bulb)
Current Tolerance.
ppm
0.10
0.10
0.10
Tolerance
Reassessment*, ppm1
0.10
0.15
0.10
Comment'
f Correct Commodity Definition]
[Fruiting Vegetables (except
cucurbits) Group]
[Leafy Vegetables (except
Brassica Vegetables) Group]
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 al!
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. l(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 Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans mat is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was
scientific 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
FTFRA and, to the extent that effects in wildlife may help determine whether a substance may have an
effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
36
-------
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 noj 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.
- Require respirators for commercial or "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.
37
-------
- 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 DEEM™
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.
38
-------
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 IE 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 Ibs 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
39
-------
standard assumptions for the chemigation use, and has indicated that the herbicide is transported and
distributed in bulk containers, not in (he 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 mat 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 me 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 IbsVacre 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 ffl 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.
40
-------
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 push-
type 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 short-
term 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.
41
-------
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 Ibs 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 Ibs 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, rnarnrnaliark, 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.
42
-------
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.
£. 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
43
U.S. EPA headquarters Library
Mail code 3201
1200 Pennsylvania Avenue NW
Washington DC 20460
-------
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
AgDRJFT 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 830.7050
Guideline 830.1800
Guideline 850.4400
Guideline 850.4225
Guideline 850.4250
N/A
Guideline 810.1000
Guideline 860.1500
(Guideline #63-13) Stability of the TGAI on exposure to metals and
metal ions
UV/visible absorption for the PAI
(Guideline #62-3) Analytical Method
(Guideline #123-2) Aquatic Plant Growth and Reproduction Study with
Duckweed and a Freshwater Diatom
(Guideline #123-1 (a)) Seedling Emergence, Tier n
(Guideline #123-l(b)) Vegetative Vigor, Tier H
(Guideline #72-4(b)) Life Cycle Invertebrate
(Guideline #90-1) Use/Usage Data
Crop Field Trials for fruiting vegetables (except cucurbits) on non-bell
peppers
Regarding the use and usage data cited above, as discussed in Section ffl, "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.
44
-------
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 Ihis 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. Flis phone number is (703) 305-5697.
45
-------
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.
46
-------
2!
«i
S !
e |
O) i
oo
•JS
41
.C
«
1
!
se Pr
ng
Manufac
SB
O)
en
=
ca
TJ
£
O"
OJ
1
_o
_o.
u
Si
=2
•3
H
Q
•£
§
1
ng
formulation into an herbicide for the
ing supported by MP registrant]."
§1
to
be
ul
in
c x>
"• **^ C '^ ii -^
" 3 o £ 3 i
c KS "-S g-13 E
p
8 S"3 ?« |!
C E 2 -S 3 3 o
t«
.S
"o
c/3 ts -3
-------
£
58
e
*•»
4*
i
0-
•~_^
s
1
cupa
fo
H
i
!
^-
1
l I
«
il
***
s
"o.
£
I
Q g
i I
s- to
pQ CU
oc
in
te
i
.1
t
£
-------
o
-Q
CS
Placement on L
DC
C
=a
^
a
H
•3
I
s
o
c.
"C
fi
o ^^ ^3
C/2 "-J3 *^3 "^ rf>
^Z) w* "Si "™™"^ •*«*
Precautionary
Statements: Hazat
Humans and Dome
Animals (Immedii
following PPE and
Safety Requiremer
o
sn
(L>
"o **
•S ^3
x ~5 o
Si 6
Si s
" w 3
c ,O i>
a *•" £-
^J CO
— ^^ C
' "* _^
•° •« 'S
o c '5
"o .2 £f
O g CL
M CL, DH
•K -1 ^
fe ^:
« u S
"Engineering Controls"
"Wlien handlers use clos
requirements listed in th
CFR170.240{d)(4-6),tl
specified in the WPS,"
no
"^
C
6
sn
c
'5b
_,
c
ca
y^
Precautionary
Statements under:
Hazards to Human
Domestic Animals
u
to
•i
3
S
8
O
C3
"o
so
'S
»•
^
SO
c
g"^
J5
CO
1
'C
f
w
s« S
S |
"ee ^
"O «
"User Safety Recommei
"Users should wash hani
toilet,"
1
*!
^ =
oo £
*» C
U 0
J« «
60 „
= -^
immediately follow!
Engineering Contrc
)g_t
1
s
H
-y
1
JQ
i>
*^
• •-j
w
t
1
*s
L
5 ci5
&1
f-e
Ifi c
J S
0 O
1§
c "*^
O ^>
22 i*
1) P
?!
«*
.SJ
||
<4_
O
•8 s
| ~ ^
1 ""
1 -1
•5 8>
^ -g
t3 "g
u2 ^
1 ^
K 3
-C P
O
CO r^
.S *
C CQ
Cq >
t Jf
f^ ^^
OT "35
tl
•2 |§
II
•S w
S
gi
il
III
3 CO O
-------
*l
«
^•r
i
1 8
I?
'
-------
•s
•3
C5
s
o
•4-i
3^
s
i
J
&ri
hfi
ed Labelini
t.
¥
gj
£
I"
W
Q
r- *>
S > ..
. juj O «<>
.1 £»—
^^ ^3 S
"o " 5
p— - ^5 3
*""* w O
'"" tfl 5b
w 3 <. •
t-> "~^ ^ X
CO »-i 4) O
E <2 5 a
2
^
u
4-*
'53 i
•»" S
§1
si
£"
<5 C3
•5 ec
0 .C
e "^
s «
cj u
o ~
ll
° ">.
^M Cw
"I H
"Do not apply this product in a way that *
or through drift. Only protected handlers
c
•£
"n.
r;, tr.
<|
2Q
• mSf
li
C ci
5
lw«
<2
cn
C
•2
S
XH
'Q
r-
O
3
T3
i
s
•n
c
"i
-Sr
E
"This product may only be applied by che
S
._§
"3
'•i
£
o
•1
4=
U
<-*
•"" ?—
5 ••§ «.
!_ CO 5
o w • 2
C/3 j"T" • "•"
font CM tj
S -^ W3
. «* TO (JJ
O O fin
ar-
n^ ^O
3 o §
rf^
S
.S
ca
1 f
1 1
H
ea -a
s -s
« 1
3 _2
I S
;£
t/5
1-2
o'l
'S 8
= ^
Q-'C
< Q
'C 2
t> Q.
< C/3
CM
1
C
"iT
D
c
CB
1
0
Ui
c,
<£
•o
•S
1
s
u
•§
1
0>
C/3
•o
X
C/3
C/" ***
c P
CO .K
o £ «
-a 3 <
g-> c — o
C iS L^ fli
O C ^^ *"*
"3 M T3 O
0 B 1 S
y ra c3 ^2
a. oo s a
1
1 g 1
1 S aS §
1 11 11
s l§ &s
•C >>i 1 CO PC
« — 3C •— ^«
.S . fe 53 °.
•g fp ,-c O o-
S ^ 5~ ? ft^"
'llS lz"
^ 5 rj ^ c"
'*™* 21 ^"^ ^i
til !i
Hi. 11
O r , ^^ •*-* f^i ' o
^ ^ U* jS S ^ U
1 S •*•§ ^ " g
fliij . -H | ,
C-.*r&-^0 « ^2 3^5
~-£ &«S JJ .. 1 S o- S 1
I-iSBg. 1 1 If i £
lj!g'?| 2 g rf SS ^ §
3 L> H 3 OU c/3 ^— *£ to (**\ ±3 "^
fljjj i 1| ll 1 1
|fi«| 1 ll|l^ | 1
^•^h$» ^ -a'«gg:U ^ x)
£11=1 -a ^ s ^^ 1 1
•s -s « «2 i « Js'S.^u o 8
§Ei3«r3 S2 t?'s§3OH S "
III-I1 1 III!! I J
JODCOU 3 ****£X < *
-^
tu
CM {/3
f ^ y
U|
.^ ^3 ™"
Ijl
tU « "- '
JJT" -fc^ . |
e. aJ <5
-------
1
e
e
S
S
SJ
w
es
S^
1
J
I
•g
e
S
a.
'E
o ^
O "cH
OH Vj
-4— >
1
O
i-(
13
o
£
1
.1
1
5b
£
S
"Personal Protective Equipment (PPE)
Some materials that are chemical-resista
w
o£
1 ^
C
U ^
.» ^3
||
°~ ."3
1 .1
E 5
E _o
O tr;
en ^
^ y^
S3 "^
N "^|j
= i
£
o .
E <
c w
II
g^, ^M
^-""s O
21
°5
"c ^
material as per instructions in Suppleme
options, follow the instructions for catej
u
•g
«M
cu
c^3
1
«2
ti
1 chemical-resistance category selection c
1
ts
13
1
1
1
j=
o.
1
CO
1
"3.
ex
1
* coveralls over long-sleeved shirt and 1
* chemical resistant gloves,
* chemical resistant footwear plus sock;
%
c
~c5
1
1
00
i
w
•S
'5
w
4
aD
| * a NIOSH-approved dust mist filterin;
^
<3
w
i
S
K
rt
•£
1
o.
£>
1 prefix TC-2 1C or a NIOSH-approved :
wear:
All other applicators and handlers must
X
«=
B
« Q_
kM !••
S ,0
^ £
||
?i
!•!
§ o
o =?
il
8 =
14! O"3
8,1
i .c
c .ts
la
fil
S3 P-
rf H
| .g^
g> if
_§ g ^ .S
•ao « B
S "MH S W3
m QJLJ Q ^T
tt S « •§•§
1|| £|
•a « S ** o
o i> o &
5 i- to *3 o
5—3 c c:
Jt> S "a. .0 «
*P 'P 58 S T"1
g3 1 o :§^
^ •§ -S w S
* * * £ Z
1
u3
'C
2
5
. 00
c .-.
« 2
-S «
'1 -a
si.
TC-2 1 C or a NIOSH-approved respira
repeated exposures) when applying this
fN
-------
"3
Placement on Lab
Labelin
I
g*
K
CM
C
_e
"Z
u
en
Q
0
Precautionaiy
Statements: Hazards
Humans and Domeslii
Animals (Immediately
following the PPE
requirements)
£ _
g J
O •— '
t> £
i >^
•6 ^
3 5
p 1?
t : .
^^ *T '
. SL.
E ^
•1* .«
1J!
= ^
's a
1 f
.£ ^
S 'S
"o ^
i2 5
*^« »c
§1
Bl
£3 j-n
.1 S
en ^
•C ^3
S 0
3 "3
1|
3
^T — ^
CT1
= J= "3
^ ra 3
S
g
H
I
X
"ra
S
13
2 o >> S ^
Precautionaiy
Statements: Hazards
Humans and Domesti
Animals (Immcdiatel
following PPE and U;
Safety Requirements.
V)
^ C
g 2
3 . 'S
croi S
«
1*1
C V
6-g.S
k- Cs5 3
0 -0 CT
E/1 CM S^
^ § &
5/3 » h
•^3 o ^s
s lei
{/) (j) Q^ pC
O u ^* ^
^ M W ^£?
(3 u > ^
ftO ^n ^^ ^r
In "^ ^™* r^ ^
c C -S S CU
'a ^ -g ^ ^
- > ^^ "*~* ^? W
r s = ~ -s
C/J
*O C/3
II
O p
ap S.
•£ 33
" cr
•|~
UJ £
— >_
a .j >, u
Precautionary
Statements: Hazards
Humans and Domesti
Animals (Itnmediatel
following PPE and Ui
Safety Requirements.
aj
"
_y S
""^ "^ *"
1|£
•S o •>
~" r- >
1 ~ u
u ~ •£
o U •—
f U
5 8 '8
ja *O O..
« -i w
llf
i. 3 C
1> O h*
C 1* t>
C" *^ *£•
c "2
• ™ '',."* 2^
IP
g£ (HIM "
J2 -o -§
*c/l ?5 •*•* cj
"o ej M S
-b M c fa
o 3 .2 '3
I i^s
^i "^
C G U «i
'5b ^ -S ^
* ^ i-^ ^"
^ r ^^
00 «
*o "o
11
U S.
to ^
•s-|
'i3 "
[2 •«
Vl
«
.0
1
£
0
B
(2
t
t3
on
^
M
D
u
w
_o
f**
"« §
S S
en 35
3 a*
-------
"v
i»
J
s
o
1
B
i
£
Required Labeling
e
o
•c
a
1
O
cp
'Is E ^
fo !>^ O * "•" T-_-,
bj| i>'^ 1 H
c .£3 C/D § ""* E
•& § J3 £ J= §
^ 1 D 1 b 'i
I & -s 11 ^
o ^
"Environmental Hazards"
"This chemical is toxic to fish and aquatic invertebrates. Do not apply directly to water, or t
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 appl]
when weather conditions favor drift from the treated area."
en
|a
CS
*T-<
i
M
CJ
=
.1
%
u3
'en
s
N
•S
u-
"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 i:
bees are visiting the treatment area."
is sn
"Do not apply directly to water, or to area where water is present or to intertidal areas belo
the mean high water mark. Do not contaminate water when cleaning equipment or disposinj
of equipment washwaters."
.1
1
.=
T3
1
:*-,
en
•s
IS
I
I
•3
D.
en
O
CO
g"e!
**" J3 co en
w S c c
c rn .2 .2
| •§ | '1
"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."
>^
_*;
rC
*l
"T =
SI> 0
.£ §
U *H
£Z ••»*
| $
& ca
i
"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 BOLD
FACE TYPE AND/OR RED PRINT OR OTHER METHODS TO ENSURE THE
WARNING IS PROMINENTLY DISPLAYED ON THE MATERIAL PROVIDED TO
THE RESIDENT."
•*}•
in
-------
as
o
S
O
2
BC
^C
w
A
JS
•8
I
S?
1
i
1 O O
cc c^
.a .a
-S < ^
« s a
|
aufl
•£
1
a
i«
^"S"!
«
2
1
i
SP
S3
ed
u
B.
•8
I
H
j
>-,
^5
1
&
C3
o
1
-f
1
1
CO
i
?
O
•S
S
u
8.
r/l
S
f
-------
4>
.2
1
a
S
Required Labeling
B
.S
."s-
1
Q
£
li
1
£-
0
X
*
£
1
j>>
1
u
Products Int
as
i
g
D -5
£. e s
*• y so TI
?-"S 11
^laa !1
C 0 0 0 ES ,_
.2 O "-S '•§ g J2
•*~* t^ 25 ._M rjj Q
H o g -P 53 o in
•Sa 12 £ 8 S w &
Q § £ £ c?> -S S
53o
S^5
J L_ i«
^u^S
jj k_; QQ ST
H D (- Q
< Q D -3
^ o z p
«^§^
^^ Un< ^LH ^^
t 22 ^ en
- . ^^ i ^^
55 C oS
WILL NOT WORK UNLEJ
•ETY REASONS, WATER '
ING APPLICATION FOR 1
R PETS ON TREATED ARJ
19
Siiii
Q ^H@2
§2o|s
£ ^ d <
^S3g^
£^2^S
^isln
i^fi^s
S iQ «< ^
^zii
« £r z "— J
= oi O f; j
1 o o o o
- u- oo Q u.
I
> -
.2 S
' ^ W
C8 '-S
•a -g
g-tn
CL t>
< Q*
K
^..^
fe 2 ^
{*- U M
S
cm
'2
1
o
u
§
o
1
CO
I
— 'Sb
.2
-------
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."
57
-------
58
-------
VII. APPENDICES
59
-------
60
-------
OS
ai
S
O
Es<
id
J
03
3
CO
Ci
X
a.
O
u
02
<
X
B.
&.
<
,+
a
P
c
e
1
.£
y
*«
1 £>-
§~ "" £
- S
<
1
(3 W
<« i2
I
%t w
M &
S <
u e
"So .2 •T^
•= S 2 5
^ .H « "3
« pj r^*.
S <
c
o
1<
£
8.
£
c
c
u
1
CA
Sft
| Food/Feed U
"a
p
H
1
I
— ]
?1
1 Brassica (Coh
"5
rt
ji
^E
0
c:
*-
o
*;
1
C
5
Is
£ o
J* -c
y <
5
rM
|
q
Q. u
£ T;
u >%
1
o
•o
ki a
B "3
^0 £&
•* 0
§
=
1 I
« "5
t, 1^,
c 3
£" ^ -— »
O fij eft S
.11 1 § 1
— eo a x> ca
eh o -a ad
fl =S I
£ o. i/5 c9 CJ
1 Carrots
Vi U
S 3
a u "3
1 | 1
H ^ '-
*^ '
lil
,t; is
X rfi 0
^11 -
•— C. t- <
"O in O >;
«j "" — 3!
'g "o "8 £
a I 1 I
•™~i -C *s w
HH' — C3 W
OT
P
O
§
S
E-S
^^
<
0
>^i
ad ^
f 1
T vD
-
h-i *J
| I
S =
o 2
E- f -v
SB S §
.S | Jj J
"g- 1 =1
el c. w 3
-------
"to
e
o
g
c
4
§
Z
1
s:
1 fr"^
& es .!
1
py* Q
°? i-
S
2
% «>
X 0.
« ta-
rs <
i c
list
ir*
1*
E *
£
g.
Site
Application 1')
in
2
W
I Cucurbit Vegetable!
•£ -5 _ < -B
= £ ^ u i
•c e " -S 2
3 '-» 2 -o '6
£"§!.= 1
•* a o j: s
o * E 2 c^
u fe -S £ ^
= <£ a a. .S
-22 ^^ C o L.
a S - Jo 3
1I|I §
£ &•§ £ i-
o 2 = j« =
* O u c °
&g 3 [2 |
S *3 rf . S
fi z & a §
•S < § J |
B j •= » a a
•* < i g •§ §
&- S 1 J -c
< 'i .s S u <
Cfl
S
JS
(N
I
o
vi
g. t>
^ "R
i "
i
O
vS
id ai
1 1
Tl- 0
s
3
g
o si
•B ^
I 1
1*2 11 §
.so -30 •=
— SO !3 J5 13
g & s "2 .s?
tl f 1 1
I g. sS a
&•
1
w
I Fruiting Vegetables
•3 —
| !?
| K§
1 1L
-S a = a
S I?!
8 -o S §
^ •§ € 2
i |i 1
1 S-5-s
E £ = '£
c — >> _
OM "^ ^3
i^ r- <•...
'i . B o L-
§) as S B, <~
.^T r- M t. b.
s 1 -Sac.
s -c -e p: s
r^ i2 ^ o v
U < _] n. c.
2
ss
o
^
ts
1
o
vd
s- °
|U
^ O
|
o
vO
U U
u u
i i
TC 0
c
o
?
O A
"T3 *"
W *"
2 1
1 i
SB If c
.SB -g S J
i I? 21 .§•
— E -o i E
g- 1 •= 1 1
£ i. £ & u
-------
tr.
|
c
c
O
0
(^
TS
^
E ,_
-' C* *!3
•3 e fc
t> c* c>
!*£
"5
^ -s
"5 H
S
S
X •*"
nj C.
S <
4.1 ^
•— •* 3 5
>< "5, ^ -D
S£ °
c
p
u.
a.
f~~
£i
.2
IS
1
0 <
.32
"3
re
1
<2
5
.£
I
J^
"c
o
>>
E
c
0
jp 2
'£ 5
u -S
0 <
3
0
^z
tN
S
o
vd
C. aj
S "o
JJ >>
<
s
p
y Id
f I
•^r ^o
o
s
1 1
15 ^
IJ^
^ C o C o
— Si'S^ c3
5 fe £ "S .2"
£• 1 1 I 1
£ g.5 « 5
2-
w
*H
«
C
,_
*-
"5
'§
• •-
0
fi
g
o
^^
• — '
s
s
o
_o x
<
s
p
bi kj
I f
•^r o
^^
c c.
• — T*
Seed bed preparal
Soil band and bed
(grflimdboom)
"£.
J
I
U
=0
u
"£n
E
—
ST
x^-
I.cafy Vegetables
c
?3
.2
p
(*
Is
g
J,
~
0
£>
E
c
.0
^5
P O
5 .g
5 <
E
c
x:
"^
<
s
o
M9
•5 -^
<
^
C
*C
a '^
1 |
O
O
-O S
1>
rt "c
&• S ^^
§ 2 SI g
'i 1 11 1
— £ ^5 c
II 11 i
-------
•v
c
£
o
y
o
'C
1
e
"3 c £
}il
*_.
crt O
. f-
i
X CL
<8 CL
S <
_o e
^ 1 | «
2 *
g
— _
1 £
EL.
(-
s
o
'^
1
c*
_Q
"5
s
2
o
•c
5
.2
c
iS
]5
.s
§
o
"c
o
1
|
.§> s
£ o
o .1;
y <
P
0
CM
^
O
\D
g. _o
^ >>
^: ,
c
- O
< 9
^ CO
•o 'E
£ •--
rt (*-
O ^
^ &Ti
-- n w
•" PO -ft
1 11
3 « s.
u;
S
o
—
<
p
l«
<
£
^
y
BJ M
1 1
TT O
§•
•6
S1 "g "s"
^- — o
£ c« -£9
-------
„
jjjj
l« =
"5s
i _
J s
. H
s
2
x c.
W Cw
s <
o c
"§* -s i?
«1 S ~ ^
3 ''Z.* JD
s £
c
o
l<
o
u.
o
c.
5
15
£1
1
£
c
.5
M
C/T
_5
O
T3
0
V3
£.1
c H.
5 —
o 5
S> c 3
B S S
.2=2
c =2 o
° 1 o.
<£ £ .2
N: o -i
< a I
03'-
~ -a a
1 £ S
"? £X)
" C C
^ ^ "5
111
£
3
O
(M
<
£
O
o
g. 0
O ^.
^ C>
<
g
o
)ri
I
^
a
"B
a _
i- 1
1 |i§
ra S TJ M
— . a c •-"
ex, >. -c 3 s
» -g, = * §
M
-o
c
«»
.S
1
iH
?3
r*J
u
^
s
8
o
"c
c
c
_o
CD CS
•« Z
r S
S <
4-!
s
*
£
O
v*
g. „
(J ^
<
^
p
O w
l> I
rj- -0
I
~ t
£ "c
.18 If 1
^ to « J3 a
J S 11 f
II 11 S
c
•^
^
c*-
"
™
g |
£ -r "?
3 "— "o
•p "t^
ro
<5 o 4J; o
T ^ tn O3
-^ « c c
< S c ^
" f S
Uj 0.
CO
CM
-------
c
o
5
c
.2
•£
S
a;
Iri
|ii
MS O
. f-
1
* in
S £
2 <
t-2 ?
| | S |
S ^- ^ —
S <" ^
J
15
^o
1
s
o
s
u
1
•baccous Plants
o
c
e
13
•g
5
S
1
,tH y-
3 |
i I
§v
^
is '^
— £>
3 c
>> "^
C UJ
S 3
O i>
s ^ e
£0 « 0
•P 5 =
a -c »
u < S
12 hours
.
£
ss
^j
i
*
o ^
1 §
U T3
3 Si
e. 5 £ e
o-o 0-2
*j ££ ^3 A
C C T3 S*
c3 rt ^ "p
ft i 1
ft. 5= w U
3
m
c
1
a
as
.2
£
•— v:
2 i
"Z "^
S 1
u t>
o 3
:>* ws
o
o c
>^ —
« *O
E in
C o
'53 • —
=0 g O
I g °
^ *Z rt
5 < 2
1
c
:>^
The restricted cntr
jH
§
s
13
t>
rt
J=
*"
u
c
i>
o
-13
workers arc allowc
i
«
I
'C
«
a
S
1
•5
The following rota
_o
>•-
re
fi-
_u
.
«*
'c?
to
.s
labeled crop group
*
5
1
o
I
*— «
'•^
ts
3
£
1
o
.£
T3
C
C3
uf
C.
S
U
U
i_"
1
S
S
i
'c
1
n
Includes broccoli,!
1
o
5
"3
C3
O
^
J=
U
'3
^
a
n
J2
J3
Cllincsc mustard Ci
-------
_0
1 1 a>
J J '=" "3
= s 1 "2
— O 3 *— '
•# g"iii
£ « ^ EC
1^-11
^ — S" "-
c «^i -^: "t^
5 g 1 *.
S 5 § IT
•S 5 -K |
fHi
^ 5 S o
S o CT* ^
3 i -o S o
? §"-8 "1
5 o c ^
•^ -C -ifi ^"
* § § -2
= 2. S S
1 ir E
!§.=
. 5 & a
u y. v. -
U h t. S
1 £! 8.
Il 1 1
S ~5 "L js
- 00 M «
1 § | J? §
= 1 f &|
e c — cc P
i P ^s I
•5| f J 1
? 1 •§ 4 1
•3 y £ "; 5
S n- o R ^
~ J3 J* 13 4=
cfi ^ re o tfl
C « c 2 «
1 3- rf ^ 1
« O O C3 ^-
II §11
| 1 1 -g •=
^ U O 3 §
^ t> ^ O" -y
I^c-U
? £ § s1 -S
stiil
?l!H.
^j " p_ ^ r-
"51 V. " •£ ^
S. 3 C il 2
J71 ^ Q y 3
I «1 gf
1 1 1 i" I
?:
S
O
Z
O
S
_o
~
75
c
T3
C
I'
II
fr|
(U O
•^ y
3>
oT "
O so
c .2
O L-
ng peppers, pir
ell pepper field
2 •£>
2 s
8 «
2 "g
H
a a
•g J
2 S
o X>
II
ff
0 g.
£ &
o e.
*!
c o
C. • >
O X
C. 3
>> 0
t 'C
U ^
-^ y
y i_
T3 O
c ~
= "0
11
- U
ct 5
"E. j>
a> -C
cfl *-
S S
T3 !f
1 1
£^
"c.
3
c"
"S
^ "S
v; ™
S 0
" .2
^ '/>
S^
- c
C «
1!
-2 -^
l-g
*c i.
^ .2
mum (edible le;
•jarsley, radicch
t>
£ j=
c u
1 *
•s f
11
«. s
0 S
3 U
~ H
o 5
fr-2.
o -5
o> c
0 c
3> <£
o ra
C ^3
^ §
y y
«1
C u
5 S
^1
o ir"
3 13
cr fc
£ o
rs ^
H
t/i C
11
U
5=
o
§
n"
o
s.
u
CJ
5
o
c
cr
insy, primrose,
c.
3"
o
.31
i
13
1
E
o
u
«£
S
•^
u
•i
•3
3
0
c"
?
c
1
s-T
O
"tn
*?
^
1
3
=
1
I
|
•a
-*"
1
_-
is
1
-------
V.
1
c
o
0
•a
Ji
o
•c
U!
Or
a:
11
II
"5 -
0
a
s
sf
^ c
'd .s i ^
S' "5. °^ jo
_ £ o
2 <
.2
P
&>
CL
r™
c
"5.
c.
«, <
5.
U»
(M
P-
t/1
J
^
^
V)
53
JS:
v
olf Course
^
T3
£ O
§ — *
•58, 2 -S
S M U O
•^ ^s ^ ^ «
llllil
c. ^ c -s; o -C
> x ® — ic
o J2 ft> — Q, 2
_: n i: < re c.
S z
£ £
CM (N
CM M
rvi CM
» • b a
2J 0 S fxi
•o
i- e
•c i
i -5
E, £
1/1 JI
E||«
§ 2 g z
2 TS a «
•g s - S.
3 o =• a-
C r* ^ «*
5 1 £ .3
oo
-------
1 £
& £
H
2 5
v s
•a o -v
= a o <
55 S 5 •"§
ws o
&•*• ^>
o
•5 <
*>-> 3
ilU^?^
1:^ 1 £
2 *- K
J 2
o •£ e.
li?!
ills
II
•s 3 i-
2' c
Ili
1 I
U
l
ii
£ ~
P I
T3
C
O
fi
-------
vi
Rcstrictio n s/Corm ncnl
II
0 U
at: £
1 -
X |S
"oO .2 *?
.0 ~ 0 <
e
_g
*
M
c.
e
o
a
"5.
a.
c
1C
o
M
May not be used on park
recreational areas, or
ornamentals and ground
covers.
Do not use a bellygrinder
or any other hand-held
method when applying.
*
J3
>n
0-!
(N
d
-^ _^ —
CJ
•a
«
5.
c.
o
a
O
r-
-------
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.
71
-------
o
S
o
'5
±
"3
cr
tf
2
"3
an
_c
V*
i
>•**
C/3
CITATION(
ei
w
*s
D &
REQUIREMENT
|
3 |-
'•3 -H
•o §
0 Z
t*
»
*O
^ "i
«J 5
Z Z
C/3
I
3C
U
U-»
— .
HJ
Q
o
p^"*
o
r^
f^
sO
d
C^J
OO
o
o
;
'D
^
1
<
T
r-
0
0
Cs)
d
1^^
oo
sC
in
^^
oo
in
^—i
o
o
1
SO
"^
U
.^
1
O
i
^i
1
Q
.i
<
<
*?
r-
o
0
fM
d
>n
oo
l>
m
m
*-^
O
o
U
^^
0
Q
1
^-
I Avian Dietary Toxicit
CQ
ol
i
t^
o
0
CM
CN
d
in
oo
O
O
o
rS
Cs
U
l£
>
£i
'3
2
°?
r-
o
o
fS
d
m
oo
O
c^
vO
cc
^f
5
1- -,
c^
Ox
1—
rs
*—*
<^*i
^f
„
o
o
SO
SO
m
"*
g
.^^
'5
0
Avian Reproduction
<
^
r-
o
o
rn
CN
d
l^i
OO
o
Os
OO
O
o
SO
— ^
SO
5
t
*._
0
ro
^^
,
o
Os
CM
«^
CO
"^
d
.^^
^
^
Q
•
Avian Reproduction
ffl
'T
r~-
O
O
CO
CM
d
m
oo
sO
CO
r-
-
•"3
* ™^
c2
-------
e
n
«M
O
b.
•+*
en
B
*iZ
B
A
.b
'5
cr
3
O
G
••e
a.
5
C3
<~^.
V)
1
0
1
W H
» <
13 a.
REQUIREMENT
•0
1*
15
O 2
g
1
C O
K.
* £
o 5
Z Z
1
cs
(N
O
CN
O
O
in
r-
^
U
,3
^
Estuarine/Marine Toxicitv - N
ffl
i
r-
o
oo
rs
fS
o
rn
S
O
r-
^
U
g
rr
Estuarine/Marine Toxicity - SI
U
i
r-
oo
§
O
"'st*
CL,
0
H
Q
^
U
<
'.J
Estuarine/Marine Invertebrate
Cycle
m
i
r-
^4-^
O
IS
3
C/3
a
c
o
oc
c
'o
g
O >s
•a -a
•si
•s «
^* SH
§^ -*S
f^ c/5
^^
il
^
u
1
'J
i
P-
in
—
O
l/^
oo
ft.
O
<
1
X
q
Non-target Terrestrial Plant
Phytotoxicity
~
PO
_
o
o
r-
^f
~
o
S
^s|
r-
5
o*T
o
Tf
O
(N
[-•
^^
r.
Cu
<1
H J
o
O
X
g
o
in
O
O
fN
CN
0^
r-
a\
o
o
o
q
'o
3
s
o
>
oo
o
o
_
o
r-
oo
(S
o\
r-
o
o
o
0
Wl
r-
OS
>n
•^-
^
U
„_,
§
1 Acute Dennal Toxicitv-Rabbi
fs
•
oo
o
O
—
CD
•r-
00
O
1
^
q
Acute Inhalation Toxicitv-Rat
m
i
oo
g
m
O
oo
i
oo
§
(N
O
OO
r-
o
o
i
^
q
1
Its
en
Q
sO
i
OO
i
(N
o
oo
-------
va
o
c
o
0)
c
•4
V
tft
*•
c
a-
•a
•i^
O
0£
o
Q.
a.
W5
a
^•^
Q
Z
O
f_ ^
H
U
^
U4
«t
3 <
REQUIREMENT
J
"2 k.
'3 V
O •§
IK C
S §
o z
o
•?
^
'3 ^
> a
4> 5
Z Z
^
30
^f
— ^
ro
^-i
o
o
o
CO
vO
0
en
en
,
CN
O
en
^i
en
en
en
^
u
^
c
1
'3
Acute Delayed Neurotoxi
r-
_H
00
o
o
VO
d
r--
OO
o
ON
ON
m
•fl-
U
-H
O
OO
rf-
g
•
Combined Chronic Toxici
CarcinoRenicity
i/^t
i
en
oo
0
o
en
•^
d
r-
OO
o
NO
CM
0
ON
,
en
^f
rn
l/^
I— 1
o
o
u
3
Gene Mutation (Ames Te
^
CM
•Tl-
OO
0
•w*
w*>
d
r—
oo
^i—
o
CM
r-
"r^-
CM
^
O
NO
CM
0
0
f
o
VO
CM
O
— ^
"*
U
q
•a
H
l
1 Structural Chromosomal *
23
cs
^<
oo
-------
S
3
e
ffl
o
n
A
£
0)
•^i
S
I
09
•<—
«
CT"
w
13
S
"3
O
Dfi
C
r
g.
X"^s
en
is'
2
O
r^
<
H
U
§
gg
D fc
REQUIREMENT
£
1 .
'5 S
Q -S
-v c
O Z
g
I
3|
>• p
C 3
Z 2
p^
1
.
§
OO
CN
OO
oo
o
o
o
o
f^l
vO
0
o
U
<
•1"
1
o
Jj
o
o
VO
U
^^
Hydrolysis
~
0
(N
*f)
en
oo
O
~
i
O
<
s3
Photodegradation - Wat
vO
0
fN
in
en
oo
0
O
1— '
Q
So
2
00
oo
oo
o
o
o
o
en
en
VO
o
0
•<
Chemical Identity
(N
r-
„
o
c
v>
en
(S
O
Ov
r-
o
9
5
!^
OO
r-
>n
cs
^
S o
oo en
en — i
CS OO
CN «S
<
a
Nature of Residue - Plar
«
•<
TJ-
r-
0
o
— «
o
VO
oo
en
o
in
O
o
<;
ta
cu
"
1
Residue Analytical Metr
U
•<*
r-
0
en
~*
O
VO
OO
O
m
p-
m
v— i
Tj~
„
o
r-
in
r-
m
•<
Storage Stability
JQ
r-
o
oo
— "
o
XO
oo
-------
S
w
S
tt
*o
e
js
"5
I
c
(A
•*•»
S
c-
a*
!2
"5
d
OX)
e
c«
at
-*^
«
a
y*"S
CO
Z
0
I
2
Ui
Uj P"
H
i
S
§
ex
UJ
C*
%
i
§4!
s §
0 Z
g
«
1 -
? s
S 5
Z 2
__
O
^f
ro
r*^
f*")
^
_^
o
CN
OO
r**i
NO
f^l
^^
„
(N
0
r-
Tf
^
^1
2 g
p"3
US
i*!
]
fH
—
0
o
o
oo
^-
O
^^
Os
f">
Tt
O
^<
•*->
I
CO
1
•i
E
CJ
^
i
j^
•— <
o
o
o
oo
o
437826
^
JJ
i
!s
H
1
E
U
^
i
J^
—
o
o
o
00
ON
O
V^
o
o
fN
oo"
o
!/"&
o
o
CN|
ON
fC
ro
O
O
o
ON
„
o
437752
^"
^
1
i
u
v~^^.
M
S^
2 o
.2 3
*s.«
2 8f
U >
N^
1
J^
— <
O
o
o
NO
oe
rl
5/f 00
r*l ^N!
/» '— '
5T1 O
?71 O
S o'
i •"*
H o
,1,11111-j i/^
ffi O
oa °
*t f*^
*^ C7*>
O - TJ-
^^ ^f C'N,
C) ^5
2^ */^i w^
OO O
' r O O
"3" (N CN)
<*. ^
,,_
N^
T
~
^^
c
o
oo
o
ON
ON
'NO
Tf
—" CN!
o o
NO NO
^* r^^
r*** \o
t*) <^i
^" ^
— «N"
o o
ON O
IT) OO
I> VO
ro (^
^T ^f
*. r
O O
437642
436820
^
1C
"u
to
I
en
.2
"S3
E
c.
a
^
i
r-
o
o
o
oc
^™T
["""*
i/^i
s£;
o
ro
^
^
O
^^
—
IT*"
f^
^.
— T
o
r^
•^~
TJ*
[**-
r*^
^j-
^
o o
437559
436728
^
In
O
C-
I
C/3
I
E
2
U
^
T
j^
-^
^^
o
c
NO
oo
a
^~m
O
-fc
^r
O
I
a
ad
PQ
1
u
=4
si
W
"o5
U3
_^
O
OS
O
O
o
o
oo
r-
r-
-------
78
-------
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.
9
4.
5.
EFED Documents:
Human Health Risk Assessment, Bensulide
Acute and Chronic Dietary Exposure Analyses for the Revised HED
Reregistration Eligibility Decision Document (RED)
Revised Occupational and Residential Reregistration Eligibility
Document for Bensulide
Product Chemistry
Revised Estimated Environmental Concentrations in Ground and
Surface Water for Bensulide used on Golf Course Fairways
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
79
-------
80
-------
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. roENTTFICATION 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.
81
-------
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.
82
-------
BIBLIOGRAPHY
MRID
CITATION
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-l 1896.
Unpublished study prepared by Stauffer Chemical Co. 264 p.
83
-------
BIBLIOGRAPHY
MRJD
CITATION
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 typhirnurium: Prefar (Betasan
Technical): Report No. T-l 1917. 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.
0015 845 7 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.
84
-------
BIBLIOGRAPHY
MRID
CITATION
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 ED: 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. ED: 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.
85
-------
BIBLIOGRAPHY
MRID
CITATION
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.
86
-------
BIBLIOGRAPHY
MRID
CITATION
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 (Img/kg): Lab
Project Number: CTL/P/3288: UR0339. Unpublished study prepared by ICI Central
Toxicology Lab. 39 p.
87
-------
BIBLIOGRAPHY
MRID
CITATION
42007902 Lythgoe, R.; Jones, B. (1991) Bensulide: Excretion and Tissue Retention of a Single
Oral Dose in the Rat (lOOmg/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 (Img/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 (Img/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; Aliton, 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.
88
-------
BIBLIOGRAPHY
MRID
CITATION
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 91-08IB. 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, 1; Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Sheepshead
Minnow, Cyprinodon variegatus, Under Flow-Through Test Conditions: Lab Project
Number: F9209003D. Unpublished study prepared by Toxikon Environmental
Sciences. 24 p.
42750202 Morrow, J.; Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Eastern
Oyster, Crassostrea virginica, Under Flow-Through Test Conditions: Lab Project
Number: J9209003E. Unpublished study prepared by Toxikon Environmental
Sciences. 27 p.
42750203 Ward, G. (1993) Bensulide Technical: Acute Toxicity to the Mysid, Mysidopsis bahia,
Under Flow-Through Test Conditions: Lab Project Number: J9209003C.
Unpublished study prepared by Toxikon Environmental Sciences. 25 p.
89
-------
BIBLIOGRAPHY
MRID
CITATION
42826701 McCowan, C; Mackie, J.; Hall, B. (1982) The Adsorption and Desorption of (carbon
14)-Bensulide in Soil: Lab Project Number: 382398: 9607. Unpublished study
prepared by Inveresk Research International. 80 p.
42864201 Hawk, R. (1992) A Teratology Study in Rabbits with Bensulide ("BETASAN"):
Addendum 1: Lab Project Number: T-12093A. Unpublished study prepared by
Gowan Co. 17 p.
43121901 Beavers, J.; Trumbull, S.; Grimes, J. et al. (1993) Bensulide Technical: A Pilot
Reproduction Study with the Northern Bobwhite (Colinus virginianus): Lab Project
Number: 334-101. Unpublished study prepared by Wildlife International Ltd. 53 p.
43121902 Beavers, J.; Trumbull, S.; Grimes, J. et al. (1993) Bensulide Technical: A Pilot
Reproduction Study with the Mallard (Anas platyrhynchos): Lab Project Number:
334-102. Unpublished study prepared by Wildlife International Ltd. 51 p.
43180701 Mackie, J.; Hall, B. (1993) The Adsorption and Desorption of (carbon 14) Bensulide
Oxon in Soil: Lab Project Number: 382927: 9703. Unpublished study prepared by
Inveresk Research International. 78 p.
43180702 Mackie, J.; Hall, B. (1993) The Adsorption and Desorption of (carbon 14)
Benzenesulphonamide in Soil: Lab Project Number 382911: 9776. Unpublished study
prepared by Inveresk Research International. 77 p.
43195901 Beyrouty, P. (1994) An Acute Study of the Potential Effects of Orally Administered
Bensulide on Behavior, Neurochemistry and Neuromorphology in Rats: Lab Project
Number: 97252. Unpublished study prepared by Bio-Research Labs Ltd. 574 p.
43273901 Riach, C.; Willington, S. (1994) Bensulide Mouse Lymphoma Mutation Assay: Lab
Project Number: 754965: 10296. Unpublished study prepared by Inveresk Research
International. 58 p.
43306301 Beavers, J.; Foster, J.; Mitchell, L. et al. (1994) An Acute Delayed Neurotoxicity
Toxicity Study in Laying Hens Phase I-Acute Oral Toxicity and Evaluation of Atropine
Protection: Betasan Technical (Bensulide): Lab Project Number: 334-105.
Unpublished study prepared by Wildlife International Ltd. 25 p.
90
-------
BIBLIOGRAPHY
MRID
CITATION
43 334301 Whitehouse, J. (1994) Determination of the Magnitude of the Residues of Bensulide in
Bulb Onions Treated with Prefar 4-E: Lab Project Number: GOWN-9306:
GOWN-9306-AR: CSI-009-02. Unpublished study prepared by Compliance
Services International. 216 p.
43334302 Beavers, J.; Foster, J.; Mitchell. L; et al. (1994) Bensulide: An Acute Delayed
Neurotoxicity Study in Laying Hens: Phase n-Acute Neurotoxicity Assessment: Lab
Project Number: 334-106: 212-010. Unpublished study prepared by Wildlife
International, Inc. 119 p.
43459201 Lay, M. (1994) Bensulide: Confined Rotational Crop Study: Addendum: (Reference:
MRID #42578002): Lab Project Number: PMS 333: RR 91-08IB ADD: WIN 123.
Unpublished study prepared by Zeneca. Inc. 95 p.
43494401 Whitehouse, J. (1994) Determination of the Magnitude of Residue's of Bensulide in
Carrots Treated with Prefar 4-E: Amended Report: Lab Project Number:
GOWN-9307: GOWN-9307-MI1: GOWN-9307-OR1. Unpublished study
prepared by Compliance Services International. 122 p.
43616001 Beavers, J.; Haberlein, D.; Mitchell, L. et al. (1995) Betasan (Bensulide) Technical: A
Reproduction Study with the Northern Bobwhite: Lab Project Number: 334/103:
CHR23. Unpublished study prepared by Wildlife International Ltd. 178 p.
43616002 Beavers, J.; Haberlein, D.; Mitchell, L. et al. (1995) Betasan (Bensulide) Technical: A
Reproduction Study with the Mallard: Lab Project Number: 334/104: CHR23.
Unpublished study prepared by Wildlife International Ltd. 182 p.
43 63 8201 Humphreys, R. (1995) Determination of the Magnitude of Residues of Bensulide in
Garlic Treated with Prefar 4-E: Lab Project Number: GOWN-9323. Unpublished
study prepared by Compliance Services International. 105 p.
43665701 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Broccoli Treated with Prefar 4-E: Lab Project Number: 94004-GOWN:
94004-GOWN-OR1. Unpublished study prepared by Compliance Services
International. 111 p.
91
-------
BIBLIOGRAPHY
MRID
CITATION
43665702 Whitehouse, J. (1995) Determination of the Magnitude of Residues of Bensulide in
Green Onions Treated with Prefar 4-E: Lab Project Number: GOWN-9305:
GOWN-9305-CA1: GOWN-9305-TX1. Unpublished study prepared by
Compliance Services International. 156 p.
43672801 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Broccoli Treated with Prefar 4-E: Lab Project Number: GOWN-9308:
GOWN-9308-TX1-U: GOWN-9308-TX1-1. Unpublished study prepared by
Compliance Services Intl. 123 p.
43676402 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Leaf Lettuce Treated with Prefar 4-E: Lab Project Number:
GOWN-9302. Unpublished study prepared by Compliance Services Int'l. 160 p.
43682001 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Celery Treated with Prefar 4-E: Lab Project Number: GOWN-9304:
CSI-009-00. Unpublished study prepared by Compliance Services International. 219
P-
43682002 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Spinach Treated with Prefar 4-E: Lab Project Number: GOWN-9326:
CSI-009-02. Unpublished study prepared by Compliance Services International. 120
P-
43692501 Irving, J. (1993) Characterization of Bensulide: Lab Project Number: GCA-01.
Unpublished study prepared by DARTEC, Inc. 83 p.
43699901 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Head Lettace Treated with Prefar 4-E: Lab Project Number:
GOWN-9303: GOWN-9303-CA1: GOWN-9303-CO1. Unpublished study
prepared by Compliance Services, Int'l. 154 p.
43711301 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of the Residues of
Bensulide in Cabbage Treated with Prefar 4-E: Lab Project Number: 9324:
CSI-009-02: WRC-12358-26. Unpublished study prepared by Compliance Services
Int'l. 189 p.
92
-------
BIBLIOGRAPHY
MRID
CITATION
43711302 Whitehouse, J.; Kliskey, E. (1995) Deterniination of the Magnitude of Residues of
Bensulide in Bell Peppers Treated with Prefar 4-E: Lab Project Number: 94005:
CSI-009-02: CSI-009-00. Unpublished study prepared by Compliance Services Int'l.
159 p.
43744701 Kliskey, E. (1995) Magnitude-of-the-Residue Study for Prefar on Broccoli: Lab
Project Number: GOWN-9203: BENS-91-MR-01. Unpublished study prepared by
Compliance Services International. 96 p.
43746201 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Spinach Treated With Prefar 4-E: Lab Project Numbers: 94003-GOWN:
94003-GOWN-CA1: 94003-GOWN-CO1. Unpublished study prepared by
Compliance Services Int'l. 177 p.
43755901 Kliskey, E.; Jacobson, S. (1995) Magnitude-of-the-Residue Study for Prefar on
Cabbage: Lab Project Number: GOWN-9201: BENS-91-MR-04: CSI-0900-00.
Unpublished study prepared by Compliance Services International. 163 p.
43755902 Kliskey, E.; Jacobson, S. (1995) Magnitude-of-the-Residue Study for Prefar on
Carrots: Lab Project Number: GOWN-9202: BENS-91-MR-02: CSI-0900-00.
Unpublished study prepared by Compliance Services International. 120 p.
43764201 Kliskey, E. (1995) Magnitude-of-the-Residue Study for Prefar on Mustard Greens:
Lab Project Number: GOWN-9320: BENS-91-MR-03. Unpublished study prepared
by Compliance Services International. 171 p.
43775201 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Cantaloupe Treated with Prefar 4-E: Lab Project Number:
94006-GOWN. Unpublished study prepared by Compliance Services International.
137 p.
43782601 Whitehouse, J.; Kliskey, E. (1995) Determination of the Magnitude of Residues of
Bensulide in Cucumbers Treated with Prefar 4-E: Lab Project Number:
94001-GOWN: CSI-009-02: 94001-GOWN-TXI. Unpublished study prepared by
Compliance Services International- 212 p.
93
-------
BIBLIOGRAPHY
MRID
CITATION
43919601 Mulhern, M.; Hudson, P.; Snodgrass, E. (1992) Bensulide: 13 Week Subchronic
Dietary Toxicity Study in Rats: Lab Project Number: 7948: 451068. Unpublished
study prepared by Inveresk Research Int'l. 236 p.
43919602 Wilierton, J.; Atkinson, C; Petersen-Jones, M. (1995) Bensulide: 104 Week Dietary
Combined Chronic Toxicity and Carcinogenicity Study in Rats with 26, 52, and 78
Week Interim Kills: (Results After 52 Weeks): Lab Project Number: 11222: 451089.
Unpublished study prepared by Inveresk Research Int'l. 439 p.
43948701 Barton, S.; Hastings, M. (1996) Bensulide: Two Generation Reproduction Study in
Rats: Lab Project Number: 11430:491205. Unpublished study prepared by Inveresk
Research International. 237 p.
43975701 Kemman, R. (1996) Determination of Three-Year Storage Stability of Bensulide and
Its Oxygen Analog in RAC's: Eighteen Month Interim Study Report (Unaudited): Lab
Project Number: GOWN-9325. Unpublished study prepared by Compliance Services
Int'l. 132 p.
44052701 Dean, I.; Jackson, F. (1994) Bensulide: Oral (Dietary) Maximum Tolerated Dose
Study in Dogs: Lab Project Number: 7960: 652568: IRI652568. Unpublished study
prepared by Inveresk Research International. 54 p.
44052702 Dean, I.; Jackson, F. (1993) Bensulide: 4 Week Oral (Dietary) Dose Range Finding
Study in Dogs: Lab Project Number: 7984: 652573: IRI 652573. Unpublished study
prepared by Inveresk Research International. 55 p.
44052703 Dean, I.; Jackson, F. (1995) Bensulide: 13 Week Oral (Dietary) Toxicity Study in
Dogs: Lab Project Number: 11053: 553622: IRI 553622. Unpublished study
prepared by Inveresk Research International. 166 p.
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:
5497B. Unpublished study prepared by Inveresk Research International. 44 p.
94
-------
BIBLIOGRAPHY
MRID
CITATION
44066401 Smith, D.; Dean, I. (1996) Bensulide 52 Week Oral (Dietary) Chronic Toxicity Study
in Dogs: Lab Project Number: 11478: 555022. Unpublished study prepared by
Inveresk Research. 228 p.
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
Kills: Bensulide: Lab Project Number: 451089: 11482. Unpublished study prepared
by Inveresk Research. 1327 p.
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
Project Number: 354994: 10293. Unpublished study prepared by Inveresk Research
International. 44 p.
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 Mulhem, M.; Finch, J. (1993) 13 Week Dietary Dose Range Finding Study in Mice:
Lab Project Number: 451052: 7950: ERI451052. Unpublished study prepared by
Inveresk Research International. 146 p.
44161105 Willerton, J.; Atkinson, C.; Petersen-Jones, M. (1996) 78 Week Dietary
Carcinogenicity Study in Mice with 52 Week Interim Kill: Bensulide: Lab Project
Number: 451073: 11378. Unpublished study prepared by Inveresk Research
International. 697 p.
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.
Unpublished study prepared by Inveresk Research. 46 p.
44223 801 Gorder, G. (1997) Bensulide: Tomato Metabolism: Storage Data: Addendum 1: Lab
Project Number: RR 91-094B ADDENDUM 1: PMS 330. Unpublished study
prepared by Western Research Center. 75 p.
95
-------
BIBLIOGRAPHY
MRID
CITATION
44297001 Kemman, R. (1997) Prefar 4-E (Bensulide) Herbicide Field Soil Dissipation Study
Following Pre-plant Treatment to Cabbage: (Final Report): Lab Project Number:
GOWN-9319: BENS-9I -SD-03. Unpublished study prepared by Compliance
Services International. 201 p.
44486901 Mansell, P. (1998) Bensulide Technical: Reproduction in the Mallard Duck: Lab
Project Number: OWN 3: OWN 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 capricornut jm (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 fios-aqiae (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 pellicuiosa: (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 Deterrnining the Effects of
Test Substances to the Saltwater Diatom, Skeletonema costtfum: (Bensulide
Technical): Lab Project Number: 44604. Unpublished study prepared by ABC
Laboratories, Inc. 30 p.
44720406 Kranzfelder, J.; Stuerman, L. (1998) Static Toxicity Test foi 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.
96
-------
BIBLIOGRAPHY
MRID
CITATION
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
prepared by ABC Laboratories, Inc. 265 p. {OPPTS 875.2100}
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-OO1: 007714-99-0002-TX-OO. 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-OO 1:
007714-99-0002-TX-OOO. 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.
97
-------
BIBLIOGRAPHY
CITATION
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. Preparec 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 ED 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, 00028828,00(45415. 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 90-3123. 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, 00028828,00(45415. Bensulide
Magnitude of the Residue on Squash: Lab. Study ID No. RR 90-32IB. 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.
98
-------
BIBLIOGRAPHY
CITATION
Aurelius, L.A. 1989. Testing for pesticides in Texas well water. Texas Department of
Agriculture. Austin, TX.
Barrett, M. to Merenda, J. 30 June 1997. Proposal for Method to Determine
Screening Concentration Estimates for Drinking Water Derived from Ground Water
Sources. USEPA, Office of Pesticide Programs, Washington, D.C.
Bellrose, F.C. 1980. Ducks. Geese, and Swans of North America. 3rded.
Stackpole Books, Harrisburg, PA. 540 pp.
Fletcher, J.S., I.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.
Gowan, 1997a. Letter M. Rice, USEPA, 08 May 1997, discussing pending meeting
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.
McCorkle, P.M., J.E. Chambers, and J.D. Yarbrough. 1977. Acute toxicities of
selected herbicides to fingerling channel catfish, Ictalurus punctatus. Bull. Environ.
Contam. Toxicol. 18:267-270.
99
-------
Odanaka, Y., T. Taniguchi, Y. Shiinamura, K. lijiina, Y. Korna, T. Takechi, and O.
Matano. 1994. Runoff and leaching of pesticides in golf ccoirse. J. Pesticide Sci.
19:1-10.)
Shellenberger, T.E., G.W. Newell, R.M. Bridgman, and J. Barbaccia. 1965. A
subacute toxicity study of JV-(2-mercaptoethyl) benzenesulfonamide S-(O,O-
diisopropyl phosphorodithioate) and phthalimidomemyl-0,O-dimethyl
phosphorodithioate with Japanese quail. Toxicol. Appl. Phirmol. 7: 550-558.
U.S.E.P.A. 1975. DDT: A Review of Scientific and Economic Aspects of the
Decision to Ban Its Use as a Pesticide. U.S. Environmental Protection Agency. EPA-
540/1-75-022. Washington, D.C.
U.S.E.P.A., 1992. EPA Pesticides in Ground Water Database, A Compilation of
Monitoring Studies: 1971-1991 National Summary. Office of Pesticide Programs,
Washington, D.C.
100
-------
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.
101
-------
H
O
rH
01
cr
rd
a.
$*
d
0
U
b
**•
oi
a
&
•"**
_^>
p-i-- """
om n
«-O 01
oo u
•D i • •-
oi oo a.
> IK. r*- x
O OO Ul
t f^> !V
! Q. —
1 £ - CO
f f C >
t y o
S- CB O.
O Z &
u- S «
o
*J*
2
ntal Protectic
D.C. 20460
:N RESPONSE
ft! •""
2 ** •
tates Environrc
Washington
DATA CALL-
CO
•d
(D
4-1
-H
D
I
E
o
"*"
eft
.c
4rf
O
5
1
±—
C
o
n
1
L.
O
£
01
Ji
X
1
•2
a
4-1
u
3
4-*
CA
C
•a
tv
^
u
a
CB
4)
lease read carefully th
a.
^
c
«- X
c.
4-> »
C CO
Q. u
L. C
O
«4-
i:
4-* CA
6? *^
» Cl
<0 Of
0* .C
A.
*• 0
EA C
z o
Q —
5 is
K a
IA ai
K CO
"" -3.
i
o
X *->
•^ H
^ Q5
i w
£ w
a rh
a ^
ro
H
Q) 0
•O 00
•H O\
:ase # and Name
2035 Bensul
Chemical # and Name 00
Bensulide
CM
O
0
CO 0
en o
» Wo
111*
3 a 9 x
^O ^"*
c o E-1
• CJ W -
1 a c* H
g-o< co u
|§ o o
S CO 23 a
^^
a
4-1
ID
o
'o
VI
"g
i.
a.
'"
CO
a
0
u
(.
01
•o
T! "o
C oi e»
3 "5 i;
A ij^j (g fl)
UJ 0) 4J QJ —
f CO L. W
C 4J ~- C
IB OI 3 0
«ii-£ » i;
•- o) BC to
— C s •—
4J 4J O D)
U IB TO 0>
3 en en Oi oe
•n 4^ .^
5 o C 4J-D s
e_ 4J o> ••- C •
Q. E " eg oi
0) 9 C c«
X 41 1, HI ttl C
1 ^ 3 E 2 &
• co IT *- *5 at
.O 01 O 4^ 01
Fi — L. H- eyi ce
£ cy CA
a) a. j; 4J
a. c n «
i a> *• S -
.c eo t— *^
£ ** 01 '5 CB
x,e IT i-
efl t~ 4^ w 4^
•— M et en
•^ c s •—
4J 4-> O O>
u a p u
3 « cfl « ee
•B 4J— l
O 0 C 4J-D S
Q.** S'« CB 0>
01 01 C «
XOI t- 01 IA C
I c. .- 3 O
ai 3 E ~ Q-
• eg a1 u a at
a o> o *• oi
r^— I--*- in ex
u-p
— *T3
i- 4-» CU
tt> CB "•'
CO**
01 »" >^
CA ai E U) en
- CB L. 3 C
6b. 1 agree to sat
Data requirements
on the attached fo
"Requirements Stat
Registrant's Respo
o ^r •*
I am claiming a Generic
a Exemption because I
lin the active ingrediel
n the source EPA regis-
tion number listed beloi
. 5
§
OI
en
a
»
^t
. c
« c
11
ft
«i
i^
u
U QJ
sl
*-§
01 &.
L.
rm and all attachments
leading statement may b
epresentative
O CA K
*"s "P
VI 01
f O —
** 01 0
o -2 5
a x IA
!P. ¥
*j '^ a CB
C * S Q.
18- S
Cji 4) u
10 x£ *•
•w C CD O
01 *-— ^
-C CB O. **
I 4^ « '^
4J CB 01 c. TJ
« ^ W 01 C
ej ** T7 T3 cs
»e- X— 3 oi
'--**• X t-
w •— o x: 3
C- 4-» E 4-« +*
01 t--« O IB
ej oi u A c
. ° w t. -^
«0 — — o en
4i
^
S
2E
01
O
Q.
^
Contact
1
u
«*-
o
n
X
o
-------
T-t
«W
0
H
(U
<7
(0
&
r- r~ X
0 o o til
i w p)
a *n
* £ i
£ -l CO
1— 1
.. n
w c
a: o
O -H
)-H Jj
g 1
e •
(0 0)
M ^
M
0
V
13 c;
SH
S w
s o
fn
i-i
0
00
cri
""l jj
ri to
CO z
1 S '
a J-Q *
*o ^c
i ^ «
»m S 3
ro "^ "^
fli 6 D)
a 0 S C
Q oj u S
Oi
VO
rH
0
J_^
0
o
o
co o
W o
H o
Q W. /v'
in pn K
llax
S CLJ S x
" u w -
| W >H
5 w a; H
C J H H
g-CU CO U
'« S
&< oo
g CQ a &
~
z
Jj
n a:
-H D)
9i C
4) O
K a,
0}
«n K
0)
•H ft)
^a
0
JJ C
n a
HI jj
H ja
• 3
r- M
C
0] £1
D JJ
u> Q.
n
CQ
O JJ
mo "
o a
o-aOHOUOJ
m
•a
3
Ul
Ul
C JJ
•- 1 C
^H 6]
01 E
•a m
S-H D
3 J3
O1 £
• Q) 3
tf) CO K) CD CO Q CD CO 05
OOOOOO OOO
E £ E E S £ E E E
H «H H rH H rH CNt H
rH
^H u u u u u a
>>
o
0)
0}
O
x
01
Ol C
0 l< O
g JJ V to
O 19 E MM
-H JH D £ J <
el* o bi ^ !? H
TS x u c o p;
V Q 19 jj rj O O
i— 1 r"t V "*•. 41 r-4 g
UAUW-H rH^JJOl
^ > aiT5a!*'Q,B:!3^
i>
i
O
J2
- (6
Q) .£
3 0}
IH -H
jj C
3
v a
nj o
i «
I!
o c
(0 4)
ft) 4J >
«-( 93 flj
18 m ^
•a c >i
10 T3 1)
E S &
M <-H V
On o!
E -O
n 01
-^ W N
J3 O -H
JJ >4
v o
en r
0 rf jJ
19 3
U
-------
tH
4-1
O
H
3 (U-HO) 4JCQ4J nJi — ijj
Cm -H a-H co x! E 3
•HO rHftfE -HOU^5
4-)0(C rH4J 54-14-)
ns ^ (U rH CQ JJ E
d) £ M NH co Cn ns (u
XCO 0) XrHCU fOCSrH
4J >-l JJ rH .Q -H M
•H 73 fti CQ 4-1 O JJ
0* CTfli Cii'HCli UQJCX!
4-1 o\° CU 3 3 £1 0) -H 3 -H 4J
r-i s-i^; oau jjo1
Td- U MOJX UCUCUrH
CUO CU3 tJlMd) (CMrH-H
M 43 Q 01 M 3 O
3O JJ — 0 CD acUCQCQ
JJ TS CO OJ CU MO
CD r-tC JJtTtCQ rHtC OjT!
TJrHrHnS -H 3 (C X(U
4JO1! — IO 3rH jJTiflJ
DflJ 34J OflJfO r-H-CM
M -H U - O rH 1
rHO OT) 4J r*1 -HrH~(1)(C MMrHtO
TSC 3D J J3M O(U&i
DC1) C4J PQCTlE-f 4-iQiE-"-H CD -H (OJJ
3M C4J H4J'3 CJlM
tj1 O< -H -H O -H T5 M C JJ (1)
CD rHO W3CUE (D-H N
MCQ CU-H >MM3 XJJOI-H
0> TJX U-l-Hg 4JCCQM
CU -H -HO O 3 -H M (ti QJ 0)
M4J 34J SdJCTX- 3rHj3jJ
(0-H CD MXIDfdtQ 4-(£l|JJO
M 4JE-|JJM£rH 01 as
n33 roc M O T3CXSM
'roi' !CrH SoMXi'S OM-HJ:
3-H E-"G< EtiliitOJJrH S-U3CJ
-^
M CO
— - CO
CN ^* I
mil H
i m (H i
CN CN r- O
VD H iH
-------
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.
105
-------
106
-------
* — 1
4-1
O
H
0)
01
re
ft.
r- r-
C1 CJ
*g ' ^
> r- T-
o o o
M (N CN
a .
1 s
O E
b O
rN
U
Q)
m
t**4
q
o
-H
4J 0
u \£>
a; ^. a
u o M
0 M g
M O
r \ rft
rM W
us • erf
JJ Q
C S
Q> •> H
E C i
G 0 J
O JJ J
-H C U
> -H
W co E-i
ITS <3
CQ S D
0)
4-j
4J
CO
TS
•
a
a
0)
1
S
D>
C
o
•H
y
3
C
•H
T3
-C
U
flS
JJ
JJ
c
o
W
5
s
ns
o
1
«
CJ
CL
^
C
•H X
*J t
C V]
in CJ
2u L>
^ £
0
II
*; K
QJ JJ
M C
C C
r-i "«
c-
RUCTIONS :
additiona]
H
t/! O
S 3
U
M
fo
Ǥ
"o P-i
«j ^
Q.
H E~*
"o y
c £-^
" Q
2 O
tc Q^i
1— 1 ^.
*~" i-ij
1
0.
^
fl
(TJ
a
•H
dJ
c
CJ
u
jjj
"O tl
C 0) CO
R! CL SZ JJ
W D iJ fi) ••
C *J -H C
ra ID 3 nS
>i x; o1 n
W "4- W flJ U
-4 « cd «
-H q * -H
JJ jJ 0 Oi
O * T3 OJ
3 0) 31 4) Si
0 C C U "0 =
SH 4_! CJ -H C
aj cy c eft
>- i j 3 C
JJ 0 4J O
TO JJ t> ffl
C T3 W QJ
O CP CJ D£
JJ £ X W
0) rJ ^ C *
CJ -H U QJ JJ
S^ 3 JJ E C
,15 o v« ^
^ CJ "H JJ
M JS 3 W
ns *j tT ~*^
• jj flj tn
X3 ffi C oi u
tt Q 0 s pi
U G S
•H .0
O O ^
•H O C h CJ
.-3 -^ iC 3 i3
^ jJ 51
u si a; w p
E £ c
S O JJ U
10 X X C
td E 4-> Q
t-H -H -H
(3 *C 6 iJ
• u iJ 0 <0
fl ra A U k-4
i
K C
O -H 3
- 1 si
"« JJ
3 ^4 ^ C >,
3i 3 -i -H
C O (5 *
•Jl U Q, iJ i.
U
•0 0
M _
Cu rj
S-i
•C (2
.
o c
(tl u
" S'
C3 -H
rH JJ 4J
m c
•DC 01
C "H J
s o a
i< ^-1 O
O « K
s -a
U CJ
.C O -H
JJ i-l
0 O
C 01 ^
0 -, jj
15 3
, — 3 o
-^ "4-J £ ^
J_5 -H 0 -C 3
W fcJ C AJ 4-1
ly i-i jw 0 fl
V "3 CT>
^ --H
CC -H »-l O JO
1
^
5
2
CJ
o
CM
r-l
^
fZ
O
U
^
c
a
E
C
1
o
-------
(N
0
H
0)
tn
a*
r- r-
o in
rH O
O O
TJ i '
> r- r-
O o O
h C3 CN
! !
O E
n Agency
RESPONSE
o
•H 03
-P 0 -
4J o §
O CNI CC
JH EH
eu • co
CJ H
rH CD
n} • W
4J n «
c
O J-)
^ en w
t.S B
United States En1
Wash
REQUIREMENTS STA
E
CO
JJ
o
•o
X
i-H
1
HJ
tn
c
o
o
tn
c
-H
12
jj
**-4
4)
e or print in ink. Please read car
if necessary.
\ INSTRUCTIONS: Please typ
Use additional sheet (s)
5
u a
M 2
„ M P
H u os
Q W i
° ^ i
iBI
m Q
« O *
« PC; Q
0 & M
&
Z
le
FNNNNN-NN*
'O iX UH
1C tt
g u T3 6 0 - -i
>£.UB.O ^» £ U JJ
lJ m In O ^ >. >-
1Q ^> £ 4> Qj tM O r' eft ^
rH *j £ WH rt jj tc
3 -H '4-4 ^J M-l •*-! C ' • "Hi G G)
5 iJO O O *•• fliEm iJ
U C flj O «3 -H fl
tf u c u c c n;;s.'Mi> u
T3O3O O C--4U C ffl
1 -« -H 'O -n ffl -H CQ O U O *D 0)
.C 3 M ViOJM03.CU-'H'*-tXHU-ri
*0 ^(y^O Ol^-rt w(DCO£T3
O 0-Q Q Q Q I1-UCSUO.O
Cu
O O
-------
O4
O
0>
r- [*-•
o in
!-< O
o o
"O i '
> r- r-
O o o
to cs ra
a
B I
£ O
K. r_T
u w
c g
a> o
en ft
rtj CO
u
C ttJ
o
-H CO
4_> 0 »
CD •* 2
4-) O 2
O CN K
^ EH
£X, • OT
U M
-i O
rd • K
aJ D OfS
q
CD - P
g G §
C/™, ^*
O i->
n tn w
•H c D
>-H H
United States Er
Wash
REQUIREMENTS ST£
e
V4
O
W-l
10
s:
ij
8
requested
information
£
Is
>,
a
a
3
CO
•3
C
ffi
O
^H
iJ
U
3
^
tt
C
£
10
_>
Iv
0)
i:
u
refully
<; or print in ink. Please read oa
i£ necessary.
CTIONS: Please typ
ditional shed, (s)
1 INSTRU
(Lie ad
*
^
U &
£?
! , /—I
g 0 «
0 a i
S G< 53
^1
^1
iBl
13 Q
i
0
o
CO 0
O) O
ca o
S>H cd
S 55 P
5 S D X
1 & < X
IOEH
" u w -
i w >H
2 W PC! H
- J EH w
&•&. CO U
5 2
&• i? /—i /"i
6 «« V— ' U
8 co S S
9 . Registrant
Response
|
H 1
m
- IH
00 U,
- ^
D} (0
01 u
Hl
r- a)
6. Use
Pattern
nl
0]
03 U
* ^ »M
01 0 ^
0 0.
a a^
rH
iaOHOOOJ
t
jj
•H
f
±1
to
U1
del inc
emont
3 -H cy
u g.-i
• Hi 2
<• S£ Z
CQcowcQ racQcocncoHi
OOOO OOOOOO
6ESE EEEEES
cocoooco crjcocococDco
pi f^| Pi p| Pj p| p{ p^ p, fx^
pq H ta w pq pa H w w w
Cli (X CU (X (X Oi d. ftj li Cu
2222 22222.2
OOOO OOOOOO
i^ S S 2 S 2 S 2 2 S
2222 222222
JJJJ JJ^JJJ
« « « W .WW««ttt!'Tl'T'>T'1T'
OOOO OOOOOO
pLibbtt, PL, PL, PL, &., ttj pt,
HMptlH pLlWCdWDdPtl
DPPQ QQPQPQ
UUUU OUUUUU
CQ PQ CQ PQ CQ 03 CQ PQ CQ CO
< F-4
U ff! fl
-H R; o
£ W *J **4
a; u F-I H
2 -H C U
~.. -S c 6
c w s h
C IU 0 ffl
-" >. X ij 'C I-"
iJ ij - J J< ?
U -H -H . — r! ^ S
1 .S >. JJ -2 J= -2
t- « u < U I
*-~ Ij -H- ^H iJ iJ U
>. c « — 'H « -i e -^ u
•H >. -H i* £ IB ID -i -X u x
Wija-JO^'CtTijawu 0
o — iisuso'o-Hoaj P
owro££«-^^y^^H
» s -i •-< c a, 3 n « t o
« -^ a; x r-( x ^ ••-! 0 — ! «J
a>co &, w B> s u a 3
ooo^ in^r^cpiOiH
OOOrH HrHHHCNCN
OHmf"] mmror^mm
[*-f--[>Vi) i>DV£l^VOV£) c- t> r- t> r-
CO CO CD CO CO CO
91
Jj
s
w
Ci
a
CQ
ification as to information on t.hi
ion is on page one) .
1 to indicate cerl
text of <:«rtif ical
ij <-\
•* 3
C
-------
CN
o
rH
Dl
rt
\.*4
u
0)
C
"I-!
CO
05 fd
(D IS
4J
CO
-U
CO
^
fl)
JJ
-H
D
^0
55
JJ
0-t
B
s
|K
M
H
B
— .^
o
0
M
EH
S
M
h
s
M
K
1
M
s
r-t-l
I
H
CO
a
0)
. »
fO
0
CN
i
T)
(fl
(U
CJ JJ
" 1
0 "H
3
JJ 0"
-H 41
6 H 4)
£1 >
3 us ~i
W JJ JJ
n u
^i 13 ra
i >i =
G V
13 15 r4
S3
0 Q.
X ±J H
JJ T-» K
jq IT.
- 3 <
HI 03 CX
O
U JJ -
§O JJ
C C
to 11
41 -H
•C rl TJ
1? re 4i
u cn Cn
jj jj C
D) C -1
cr r* u
ri m -H
18 Ol U
41 Q
144 Jj )>l
U 3
— 3 a
Jj rJ II
c a
5-c S
T5 4> O.
n w •*
Dl J-- U
C TO C
-r< -H O
G> 'H
41 03 T3
> H O
-•H Ji
jj in Cn
u a c
(C js -H
i- O 4)
-n C >
,£ JJ
O RJ
01 03 41
ns ?? .C
jr ct; AJ
O jV
^ y M-I
as.0
& o
(OUT!
O JJ ti
JEW
C3 G
3 2 .3
E 5! U
ii Ts
0 Ij
13 rl 4!
13 nj "
O, jj U
0 ft
^ 13 *J
too
3 H 3
'o a 'o
r< 13 U
o. a
14.
O i—i 4j
•O fH -3
C O C
4) 55 CJ
11 • (H
J-i rc
a- rj u
H 3 -H
•o p.
*J >J jj
3 *" ;;
•8 13
0 41 0.
00-
uj M —
3 3
S O -H -4
- 5 S J!
3 JJ O
3 U T3
er o c
< 6. w
1 1 1
U ID O
2
o
13
a. o
w
O C -I
O ID
•o c o
O 41 -O
14^014}
3 E
3 j? v.
JJ C O
IS 41 O
g- a i
i i i
Q n Z
S a
•o o
O >4
i2 °
O 0 tJ
c s. °
18 HI C
m J= x.
4) C O
U 4t O
U 4) 13
41 W C
H 0 1-1
USE
O, 18
O -I
- C
41
•0 13
U -H
ci cn
14-1 41
•g*
O O
rH C *O
1C O O
•H G O
id V4J
JJ tj
CG -H ^1
41 J 0
^i US O
il 3 13
41 D1 S
t-i < n
i i i
•H
a n
O 3
K T3 t
u c o
•o " •§
0 T3 JJ
0 O 3
•• u 0 O
&rt C -
!«: « o a!
» '2 c jl
Q) JJ- CJ £
•H yj --H 41
U y u T3
C U HJ *H
01 t^ 3 W
D 1) CT1 (U
, i ,
1> rf C'-» X
_2
E
0
w
§
a*
B
Pi
w
g
g
CO
M
o:
a
1
H
W
12
EQUIREMEN
a.
49
JZ
O
41
3
JJ
iX
8
o
0
c
•i-i
•a
4)
0
c
41
4'
4>
!.i
o:
c:
o
q
i:
-H
r5
'D
5;
P
" '
U]
'U
JJ
0
0
o
llj
J-
Vi C
O t
flj
ur> ^ ti
L/) O V<
r-« (M 0
co r- c
r-4 H
« • u
QO Q
-- rH
CD * O
O fH
-H •-
Jj — . . CD
y (N in
01 i H
CO r-i *
•H 03 C
S U3 fl
O Q
^ y •-
-H O "-
O r* N
iu a i
QJ
r< B y
(C E
IH
DJ Cfl O
C -rJ *"
•H IM r-
*O <3 fl
t)l l^
C ^-i fi
O 0 -
C JLJ ^
o a '
1 1 «
UJ "O -rt
JJ i- >,
Jj 0 -H
u c
X [Q
C -H >
10 • i-l
o; r- -H
K "O -«H
>. C r^
rH (B 4>
c - a
OJ (N
0 a ^
-H 01 O
Jj rH [^
O O 00
0 • *
U co
in
- H . —
•i-t r-l
JJ '• \O
13 i (0
-H (H 4>
JJ — 4J
U -H
T3 0 3
o - a
a -H -H
en
o o m
•iJ CU 0 •"•
S&i O C '
c y o CM
6 C "C -u "-*
/• 3 J5 g n
w >, o o
V. C _J -I jr
fl Ct, — i JJ
3 W C "S E
Q ^ ^ j. ^
DC flj ••"< O >0
6 -i 3 3 ^Sj,
c tr o M 10
T3 *~"
0
^
fl
JJ
c
41
a
X
41
C.
1
•rH
y
1
u
a
41
o
m
r-l
^
4)
•g
3
T)
13
41
JJ
g
0}
•o
tt
41
O
~3
m
m
g
a
c
•rl
JJ
U
"g
JJ
O
c
o
a
^
0
10
•o
41
•° •
If
C O
a to
6 FT1
O^
Ol 41
-p4
••^
O
-rl JJ
f. C.
CO 4)
< 3
(N
0
^
•a
j_j
3
CO
Jt
rH
X
01
C
T>
41
i?
-4
1
.2
u
c
c
•H
c;
o
c
o
-H
01
CO
3
0
n
13
X
1
E
O
a
41
3
1
X
c
•a
c
c
o
^
3
O
41
i— 1
O
CJ
-
3> fl)
<*J -H
^ (0
Cl H
C (0
rX
T3 CJ.1
S g
jj ic
c u
-•H C
41
'o r
-*H jj
o: jj
£. 4!
JJ
41
r- JJ
m
r_t
8 -d
C JJ
j= ^i
41 I
JJ A
3
41 a
JJ O
144 •"
rH JJ
•c
N C
>, 41
18 T3
us '«
Di
41 C
ja M
JJ 41
K >
!s
c
41 w
s °
4? m
S1 2
M Dl
Q> rl
21
u
41 41
(9 JJ
0> Vi
O
IH JJ
O C
•«* 4J
C rH
0 > B
- O g
tj J-> ^
C U 4)
1C O.
h rl X
O Ct, 41
en 0 41
(Q
•DC O
41 O C.
r4 — 1 CJ<
4> O en
•HO 3
u -o
c o
" 'o • a
>l Dl
a iJ -H C
'S I J? CO •
U V JJ V4
•C rj o] 41 jj
a ™ V 'j *
S i 1 -5 *
1 r3 ° S 3
O <3 C *H
•. cn >H n
W O w ft)
QJ O Dt
O 0 •-
E £ '3 2-1
C U- -H ;
5 u m cr
ID
C •** -H 0 E.
-^ m .ri t i
J-i C W f3
Jj HH C.
03 S CR
S1 .H o 'E
SJ jj -H
jj < a*
|° o|
i- 01 Q U
W 10 .^
> »
jj C
U 41
IT! T3
J= C
JJ -rt
IB O
JJ 13
41
2 °
K! CL
03
•H
•H JJ
jQ -H
Rl XI
03 JJ
4) c
•W u
q o
K ID
O
QJ rl
£ U
— , o
6 ~
H O
tJ
01
4J t)
.^ Jj
JCJ
QJ
3 JJ
CO O
TJ
JJ (LI
O (0
"O 4)
O JJ
•H T)
ra D* ^
•M u Cn
C .vi a)
' 4) 13
> 4)
•-< M 4J
O • (0 C
C (0 O
e t jj £
rH -r. C
O, -H -H >* O
fl] 1fal r-l -M
jj -H O (TJ CQ
•o 2 -5 o* *2
0) H r-f q
jj D (Q O •<-<
T3 3 COO
*J O 3 JJ E
C O la
S* O T3 H ° £
71 D] O JJ m
C K 3 < -^ a1 o
.^•Hjj.-4 U fl aJ JJ 0>
C C O u-i "** " O
u cj -r4 -H -H a o ta o> u
M i-4
3333334.n; u
T.TJ'O'S'Cj^— R «
aS*G.c.aS :3S — jj'
*D fcj 0) -H
-t-H !,H -"^ ^ .— -^ S^JJ-^H
•H C -2
.^ ,H .^ .rt .H -H Sa •-* ft) C
333333 31M-H
ixp.ic:2;asfl;2!.s:--H o
o^c^^^inr-cn
en
*H
CO
(0
**
c
o
M
J*"»
Vi
0
Q)
4J
to
u
-r*
•rl
X
0
£-
ED
tj
. X
rH «
tji q
X «!
o -H
K C
re C
en h
O
C 0
-rl -H
-H CD
Q C' 41
1 28
g jj *J
Q 4^
(8
rH ^M U-JJ
§i 'ri '"
41 -a 13
rH S
i -H —4
0 cr IT
x £ £
jj jj
O 0
fl 22
S
U -H CM
^
-------
CN
O
CN
0)
«n
ns
OH
Agency
c
0
-H
Protect
20460
<-* u
(0
JJ •
s Environmen
ashington, D
State
W
rt^
4J
c
D
W
pH
f~{
CO
S
S.
REQUIRE!
0)
H T3
GUIDEL 3
Bensu]
Pi 1/1
O rn
fa 0
j"v!
DEFINITIONS
f and Name : *
-*^
>
W 0)
« CQ
9 3
^
w
c
z
E-<
0
O
to
0
fB -H . — .
U Jj jm,
jj Vi •—'
, O
0 E
C
n C
1? -H THJ
C CO -«H
(is a ^
JJ JJ -rt
ra o
3 "u &
CO 3 W
4J 5
,— i tu iL)
-H 0 -H
JJ >
(ti W D
0-1 Jj H
O -H
W (g
-H
CJ U O
fC 4)
cn o o*
z: tn
5l jj O
J2 C
ft JJ O
— -H
TJ J
-H o m
•H & JJ
Jj tj -H
2 -H
"" CO
gj f^ IM
J3 >• f?
CC j— < -H
to *ns cu *
X C JJ
C O ""i
-H cn IM
i^ U
cE >-< co
^ G3 CJ J->
-H 3 ^1
C O
jj 4-i It
1-1 O U •—
« DJ iJ —
(L> C -H O
* 0 _ f>
^H U -H
^-1 -H CM
•s •§ -g s
O 1-
o u -H a:
3 ^ D1 U
(0 &
M-i T3 V< O
O C T
3 83
n -H c
1 8 1 *
tl U O
•H O 1J -rf
•O O "H
SO Ch C>
C Id tt>
O Hf U ^
4> "O C AJ 05
iw C "O H
^ y o o
S O 3 C U
o ra g -H
j "u a ~ a
C O X -H O*
•H n *c
U M (5 ID
•H -H S C -*-1
-H S C -H
• * *5 O -O u JJ
e o on
+—. li -O •-. CJ
1> 4J O JJ U
• -a u jj 3
4-3 -5 ^ g ^ J3
fj c o o. -a
0 « '" C "
U Qj ^ fo W
rj i> ^ 3
^^ 4» £ n C ^ 4J
03 to *4 'd *" c
*H -H ™ VJ 0
fj C *O 13 JJ
OJj h E C -H
0 .r-l — i — H )M
Cl a 3 3 *J JJ
,1 c1 Cr* co w
•M iw o GJ o
-------
112
-------
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 lexicological 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 lexicological
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
113
-------
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 fouid which contain bensulide as the actiw 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 fo:: informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
Batch
1
EPA Reg. No.
10163-202
2217-777
34704-21 1
769-895
961-336
% Active Ingredient
Bensulide.. .46.0%
Bensulide... 46.0%
Bensulide...46.0%
Bensulide...46.0%
Bensulide...46.0%
.&•»
Formulation Type
liquid
liquid
liquid
liquid
liquid
Batch
2
EPA Reg. No.
10163-196
10163-200
10163-205
2217-696
56076-3
% Active Ingredient
Bensulide.. .46.0%
Bensulide...46.0%
Bensulide...46.0%
Bensulide...46.0%
Bensulide...46.0%
Formulation Type
liquid
liquid
liauid
liquid
liquid
114
-------
Batch
3
EPA Reg. No.
10163-197
33955-554
5887-135
8660-128
% Active Ingredient
Bensulide...34.8%
Bensulide...34.8%
Bensulide...34.8%
Bensulide...34.8%
Formulation Type
liquid
liquid
liquid
liquid
Batch
4
EPA Reg. No.
10163-198
34704-209
769-894
538-1 1
% Active Ingredient
Bensulide...12.5%
Bensulide...12.5%
Bensulide...12.5%
Bensulide...11.0%
Formulation Type
liquid
liquid
liquid
liquid
Batch
5
EPA Reg. No.
538-26
10163-204
34704-208
769-896
8660-127
961-338
% Active Ingredient
Bensulide...8.5%
Bensulide...7.0%
Bensulide...7.0%
Bensulide...7.0%
Bensulide...7.0%
Bensulide...7.0%
Formulation Type
solid
solid
solid
solid
solid
solid
115
-------
Batch
6*
EPA Reg. No.
538-129
538-155
538-53
9198-73
34704-216
9198-72
961-337
538-156
3234-36
% Active Ingredient
Bensulide...5.2%
Bensulide...4.78%
Bensulide...4.6%
Bensulide...4.6%
Bensulide...3.6%
Bensulide...3.6%
Bensulide...3.6%
Bensulide...3.58%
Bensulide...3.28%
Formulation Type
solid
solid
solid
solid
solid
solid
solid
solid
solid
*Batch 6 products may not share eye irritation data.
Batch
7
EPA Reg. No.
10163-199
32802-15
34704-210
769-897
869-212
% Active ingredient
Bensulide...3.6%
Bensulide...3.6%
Bensulide...3.6%
Bensulide...3.6%
Bensulide...3.6%
?•*
Formulation Type
solid
solid
solid
solid
solid
116
-------
No
Batch
EPA Reg. No.
10163-201
10163-222
2217-778
538-164
538-77
8660-126
10163-203
% Active Ingredient
Bensulide...92.0%
Bensulide...63.5%
Bensulide...7.0%
Bensulide...5.25%
Bensulide...5.1%
Bensulide...3.6%
Bensulide...3.6%
Formulation Type
liquid
liquid
solid
solid
solid
solid
solid
117
-------
118
-------
Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN
119
-------
H
4-1
O
H
0)
tn
cO
PJ
>i
u
(-(
}-i
tt>
£
rotection
20460
&
.H U
ff*
CD
t \
A-J •
d Q
t
to
>i
JJ
-H
U
ress
•a
a
O^*«-(M^
«^-C3*— O'OOlAKI'OOOrO*"
os-rNj^»or'-^u*\rofM^'O^
ro^wco^tu^N.LTii>')Lni*o>4'Orn
•«O>^-or>~o>Kivroom- Z £
O -i —
O >• < 3 >- O
uj — i— x i— o ae
— i Z — 1— < i: 111 — U
_l OU UO UJ O OZOOQ:O«tlU <-0 UJ— 1
0£ZZZ~IZ-10Z^JZUJ
«: ui < «t — LU >- < zi — < a: i—
ZCQCAU^CDdE^S^OV?
rsj
ru
CM
UJ
1—
1— 1— to
O CO V>
a: i—
< < z ™
— " => CO 3 Z
<« — 1 O» —I •—
1— O N- O O
i— u «— o u ee o
O O> —• o o -J-
C03O-T<-3OO><^^~tn (^~"^OlA
«-«> o«-w>in«-tnao«O'-
<-moxxf">xxxoxxx
«»«- •OO--OOOOOOO
«— oja.oacDfMcaQaoaN-ODcam
u
:t
u u ""
z z o
— — u
- * —JO.
to Vt O£ ^ O£
o o uj o o
Z Z IN — U
*C <3? ^^ Z
Q£ D£ -^J UJ 1/3
m m — • z ui
CO >— */) U *«
i— z >- «e z a:
Z UJ Z UJ UJ LJJ h-
^ 1— •* t»- 1— h- W
O a: a a£ *— ^
cc < o: 3 « « a
UJ Z UJ O Z — 1 Z
> z > — i a. —
O O u- U
gt u> oe ui < a- LU
a: — o uj o: O >-
U. U>U. £X [_)"-•—
— u. z
I— •• O 1- •• 1- O
Z Z Z "». Z Z
SI— X UJ < t— UJ O
1— «t O CO »- O •»»
< ,,
^" U
o z
cr
UJ CO
IM UJ to
— to i-
-1 — U
• — Of =>
O i- a. g
cj — uj uj ee
z • u. i— CL
UJ - — u • Z
t_>_-tooac:utoi— zoe uj
zaooixotoi/} o o — j to
ccz o z> z n z c»u_i=i
fl- < >— o «t a o z uj o
O CD tD O UJ OO ^" CC O O O
O *-£3OC UJO-?Ot3Q£
^ -^J GC t— *J O U AC O UJ
CA^ ozz_iz aotju^
i—
^ Q U' ^^ h— Q tA 4 ^ *^ in — 1
Socuj — a: oc o: uj 3 3 — z<
ujc^cocjQ_!>Q.i— o:x:O.-3
cao-or^stfvoeoKirvjm^va
fO^OT-Ktec^oo^oinoN*
mN.eoc\j(Mcc -o«-^oot>r>-o
O^OCMCOLT. cooorvjm>j-«o
§oc^^^C'^o»-i^»roioui
OOC3C3OOOOOOOO
-------
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/opprdQO 1 /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@eparnail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Application for Pesticide
Registration/' Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
http://www.epa.gov/opprd001/forms/8570-l.pdf.
httDi'/www.epa.gov/opprdOO 1 /forms/85 7Q-4.pdf.
htro:-; .'Www.eDa.EOv/ODnrd001 /forms;857Q-5.pdf.
hrm: vwww. epa.sov.opprdOO I/forms- 857Q- j 7,pd.f_
hrtp:.'/www.ena.cov/orinrd001 /forms/8570-25. p4f-
http:'''www.epa.eov/oT)Drd001.'formS''8570-27.pdf
121
-------
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other RegistrEnts for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98 -5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-,)
Self-Certification Statement ior the
Physical/Chemical Properties (in PR Notice
98-1)
hrtp:,Vw-tt-w.eDa.eov/oDDrd001/formS''8570-2§1E,df,
htto://www.eDa.eov/ODDrc.001/fonns'$570-30.pdf.
http:/./www.epa.j{ov/oppr(!OOJ/fonns.'8570-32.gd/.
httD://www.eDa.eov'oDDrmsdl/PR Notices/or98-5.pdf.
http://www.epa. gov/oppiimsdl/PR_Notices/pr98-5.pdf
htro://www.eDa.Bov/oDDi>msdl/PR NoticesTr98-l.pdf.
http://www.epa. fov/opp'imsd 1 /PR Notices/pr98- 1 .pdf.
Pesticide Registration Kit
Dear Registrant:
www.eoa.gov/oesticides/registrationkit.
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product witti 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)ofl996.
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 Dam with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices.
122
-------
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/Arnendment
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
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.
123
-------
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pestic des. You can contact NPTN
by telephone at (800) 858-7378 or through their Web site: .ice.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 stimp 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 lias 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
124
-------
|