US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision
r
PRO-** for Terbufos
When EPA concluded the organophosphate (OP) cumulative risk assessment in July 2006, all
tolerance reassessment and reregi strati on eligibility decisions for individual OP pesticides were
considered complete. OP Interim Reregistration Eligibility Decisions (IREDs), therefore, are
considered completed REDs. OP tolerance reassessment decisions (TREDs) also are considered
completed.
Combined PDF document consists of the following:
• Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and
Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the
Organophosphate Pesticides (July 31, 2006)
• Terbufos IRED
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UNITED ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C.,
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
Page 1 of 3
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(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
Page 2 of 3
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Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
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September 28, 2001
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary and revised risk assessments for the organophosphate
pesticide terbufos. The public comment period on the revised risk assessment phase of the
reregi strati on 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 September 14,
1999. Additionally, the Agency held a Technical Briefing on September 2, 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 (TRAC), 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 any estimated risks
presented in the revised risk assessments. This public participation and comment period
commenced on September 14, 1999, and closed on November 12, 1999.
Based on its review, EPA has identified risk management measures that it believes are
necessary to address the human health and environmental risks associated with the current use of
terbufos. The EPA is now publishing its interim decision on the reregi strati on eligibility of and
risk management decision for the current uses of terbufos and its associated human health and
environmental risks. The reregi strati on eligibility and tolerance reassessment decisions for
terbufos will be finalized once the cumulative risks for all of the organophosphate pesticides are
considered. The enclosed "Interim Reregi strati on Eligibility Decision for Terbufos," which was
approved on September 28, 2001, contains the Agency's decision on the individual chemical
terbufos.
A Notice of Availability for this Interim Reregi strati on Eligibility Decision for terbufos is
being published in the Federal Register. To obtain a copy of the interim RED document, please
contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200
Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic
copies of the interim RED and all supporting documents are available on the Internet. See
http:www.epa.gov/pesticides/op.
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The Interim RED is based on the updated technical information found in the terbufos
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
assessment for terbufos (revised as of September 14, 1999), and a document summarizing the
Agency's Response to Comments dated August 30, 1999. The Response to Comments
document describes new studies submitted by the chemical registrant that were used to revise the
risk assessments, and responds to comments submitted by the registrant, general public, and
other stakeholders. The docket also includes comments on the revised risk assessment, and any
risk mitigation proposals submitted during Phase 5. For terbufos, a risk mitigation proposal was
submitted by the chemical registrant, BASF Corporation (formerly American Cyanamid).
This document and the process used to develop it are the result of a pilot process to
facilitate greater public involvement and participation in the reregi strati on and/or tolerance
reassessment decisions for these pesticides. As part of the Agency's effort to involve the public
in the implementation of the 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 reregi strati on and tolerance reassessment processes for these
chemicals. This open process follows the guidance developed by the Tolerance Reassessment
Advisory Committee (TRAC), a large multi-stakeholder advisory body that advised the Agency
on implementing the new provisions of the FQPA. The reregi strati on and tolerance reassessment
reviews for the organophosphate pesticides are following this new process.
Please note that the terbufos risk assessment and the attached interim RED concern only
this particular organophosphate. This interim RED presents the Agency's reregi strati on decision
except for the decision on tolerance reassessment. This interim RED presents the Agency's
conclusions on the dietary risks posed by exposure to terbufos alone. The Agency has also
concluded its assessment of the ecological and worker risks associated with the use of terbufos.
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 the
cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire
organophosphate class of chemicals after considering the risks for the individual
organophosphates. The Agency is working towards completion of a methodology to assess
cumulative risk and the individual risk assessments for each organophosphate are likely to be
necessary elements of any cumulative assessment. The Agency has decided to move forward
with individual assessments and to identify mitigation and risk management measures necessary
to address those human health and environmental risks associated with the current uses of
terbufos. The Agency will issue the final tolerance reassessment decision for terbufos and
finalize decisions on reregi strati on eligibility once the cumulative risks for all of the
organophophates are considered.
This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
outline(s) further data requirements for this chemical. Note that a complete DCI, with all
pertinent instructions, is being sent to registrants under separate cover. Additionally, for
product-specific DCIs, the first set of required responses to is due 90 days from the receipt of the
DCI letter. The second set of required responses is due eight months from the date of the DCI.
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In this interim RED, the Agency has determined that terbufos will be eligible for
reregi strati on provided that all the conditions identified in this document are satisfied, including
implementation of the risk management measures outlined in Section IV of the document. The
Agency believes that current uses of terbufos may pose unreasonable adverse effects to human
health and the environment, and that such effects can be adequately managed with the risk
management measures identified in this interim RED. Accordingly, the Agency recommends
that registrants implement these risk management measures immediately. Sections IV and V of
this interim RED describe labeling amendments for end-use products and data requirements
necessary to implement these mitigation and risk reduction measures. Instructions for registrants
on submitting the revised labeling can be found in the set of instructions for product-specific
data that accompanies this interim RED.
Should a registrant fail to implement any of the risk management measures outlined in this
document, the Agency will continue to have concerns about the risks posed by terbufos. Where
the Agency has identified any unreasonable adverse effect to human health and the environment,
the Agency may at any time initiate appropriate regulatory action to address this concern. At
that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregi strati on,
please contact the Special Review and Reregistration Division's Chemical Review Manager,
Eric R. Olson at (703) 308-8067. For questions about product reregi strati on and/or the Product
DCI that accompanies this document, please contact Karen Jones (703) 308-8047.
Sincerely
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachment
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Interim Reregistration Eligibility Decision
for
TERBUFOS
Case No. 0109
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TABLE OF CONTENTS
Executive Summary 1
I. Introduction 5
II. Chemical Overview 7
A. Regulatory History 7
B. Chemical Identification 7
C. Use Profile 8
D. Estimated Usage of Pesticide 9
III. Summary of Terbufos Risk Assessments 10
A. Human Health Risk Assessment 10
1. Dietary Risk from Food 10
a. Toxicity 11
b. FQPA Safety Factor 11
c. Population Adjusted Dose (PAD) 12
d. Exposure Assumptions 12
e. Food Risk Characterization 13
2. Dietary Risk from Drinking Water 13
a. Surface Water 14
b. Ground Water 15
c. Drinking Water Levels of Comparison (DWLOCs) 15
3. Aggregate Risk 17
4. Occupational and Residential Risk 18
a. Toxicity 18
b. Exposure 20
c. Occupational Handler Risk Summary 22
1) Agricultural Handler Risk 22
2) Post-Application Occupational Risk 26
B. Environmental Risk Assessment 26
1. Environmental Fate and Transport 27
a. Degradation and Mobility 27
b. Field Dissipation 28
2. Risk to Birds and Mammals 28
3. Risk to Aquatic Species 29
a. Aquatic LOC Assessment 29
b. Aquatic Incidents 29
4. Endangered Species 31
IV. Interim Risk Management and Reregistration Decision 31
A. Determination of Interim Reregistration Eligibility 31
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
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2. Endocrine Disrupter Effects 38
3. Labels 38
a. Agricultural Use Exposure Reduction Measures 38
b. Homeowner Use Exposure Reduction Measures 39
D. Regulatory Rationale 39
1. Human Health Risk Mitigation 39
a. Dietary Mitigation 39
1) Acute Dietary (Food) 39
2) Chronic Dietary (Food) 40
3) Drinking Water 40
b. Occupational Risk Mitigation 41
1) Agricultural Uses 41
2) Post-Application Risk 43
c. Homeowner Risk Mitigation 43
2. Environmental Risk Mitigation 44
3. Benefits Assessment 44
E. Other Labeling 45
1. Endangered Species Statement 45
V. What Registrants Needs to Do 46
A. Manufacturing Use Products 48
1. Additional Generic Data Requirements 48
2. Labeling Requirements for Manufacturing Use Products 48
B. End-Use Products 48
1. Additional Generic Data Requirements 48
2. Labeling Requirements for End-Use Products 49
C. Existing Stocks 49
D. Required Labeling Changes Summary Table 50
VI. Related Documents and How to Access Them 61
VI. APPENDICES 62
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR
REREGISTRATION 63
Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES
USED TO MAKE THE REREGISTRATION DECISION 68
Appendix C. TECHNICAL SUPPORT DOCUMENTS 78
Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE INTERIM REREGISTRATION DECISION
(BIBLIOGRAPHY) 80
Appendix E. GENERIC DATA CALL-IN 104
Appendix F. PRODUCT SPECIFIC DATA CALL-IN 105
Appendix G. EPA'S BATCHING OF TERBUFOS PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 106
Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN 108
Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 109
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TERBUFOS TEAM
Health Effects Risk Assessment
Jeffery Dawson
William Hazel
Michael Metzger
Christina Swartz
Environmental Fate (Drinking Water and Ecological) Risk Assessment
Thomas Bailey
James Breithaupt
James Carleton
David Farrar
Use and Usage Analysis
Donald Atwood
David Brassard
Registration Support
Marilyn Mautz
Risk Management
Pam Noyes
Eric R. Olson
Mark Hartman
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic
health effects are not anticipated to occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Gr anul ar F ormul ati on
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
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LC
50
LD
50
LEL
LOG
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
NPDES
NR
OP
OPP
OPPTS
Pa
PAD
PADI
PAG
PAM
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRN
PRZM7
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.
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.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency
to regulate contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
pascal, the pressure exerted by a force of one newton acting on an area of one
square meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
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EXAMS Tier II Surface Water Computer Model
Qj* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregi strati on Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under
standard conditions.
TRR Total Radioactive Residue
UF Uncertainty Factor
Mg/g Micrograms Per Gram
Mg/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its interim risk management decisions for terbufos. The decisions outlined in this
document do not include the final tolerance reassessment decision for terbufos. At this time, no
tolerance actions are necessary for terbufos. The final tolerance reassessment decision for this
chemical will be issued once the cumulative risks for all of the organophosphates are considered.
The Agency may need to pursue further risk management measures for terbufos once cumulative
risks are considered.
The revised risk assessments are based on review of the required target data base
supporting the use patterns of currently registered products and new information received. The
Agency invited stakeholders to provide proposals, ideas or suggestions on appropriate mitigation
measures before the Agency issued its risk mitigation decision on terbufos. After considering
the revised risks, as well as mitigation proposed by BASF the technical registrant of terbufos,
and comments and mitigation suggestions from other interested parties, including the states of
North Carolina and Indiana, Defenders of Wildlife, several property owners, growers and grower
organizations, and agricultural extension agents, EPA developed its risk management decision
for uses of terbufos that pose risks of concern. This decision is discussed fully in this document.
Terbufos is an organophosphate insecticide-nematicide used to control a variety of insect
pests, first registered in 1974 to control insect pests on corn, sugar beets, and sorghum. Use data
from 1987 to 1996 indicate an average domestic use of approximately 7.5 million pounds of
active ingredient per year during that period.
Overall Risk Summary
EPA's human health risk assessment for terbufos indicates some risk concerns. Food risk,
both acute and chronic, is below the Agency's level of concern. Drinking water risk estimates
based on models, from both ground and surface water for acute and chronic exposures, is of
concern for most populations, notably infants and children. Even when potential food exposures
to terbufos are not considered, modeled concentrations of terbufos in groundwater and surface
water alone exceed the Agency's level of acute and chronic dietary risk concern based on
Estimated Environmental Concentrations (EEC's). The Agency also has some risk concerns for
handlers who handle terbufos in open bag/open cab and closed systems (i.e., Lock-N-Load
system and enclosed cabs). Terbufos is not registered for use in residential settings, and so the
Agency expects no residential/homeowner exposures.
EPA's environmental risk assessment for terbufos indicates risk concerns to non-target
organisms. The Agency is particularly concerned about risks to aquatic species, based on the
Agency's aquatic assessment, and supported by fish kill incidents associated with the use of
terbufos on corn.
To manage risks of concern posed by the uses of terbufos, EPA considered the risk
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management proposal submitted by the technical registrant, as well as comments and ideas from
other interested parties, and has decided on a number of label amendments to address the
ecological, drinking water, and worker risk concerns. Results of the risk assessments, and
required label amendments to manage those risks, are presented in this interim RED.
Dietary Risk
Acute and chronic dietary risk for food alone do not exceed the Agency's level of
concern. However, acute and chronic dietary risks are a concern when potential modeled
drinking water exposures are added to the acute and chronic dietary risk assessment. Drinking
water risks of concern are expected to be managed by the steps outlined in the discussion of
ecological risk explained below.
Occupational Risk
Occupational exposures to terbufos are not a risk concern for most handler scenarios.
However, the Agency does have risk concerns for handlers loading and applying the Counter
15G Lock-N-Load product and Counter 20CR open bag product. The Agency has determined
that risk concerns for Counter 15G can be mitigated to acceptable levels if applications are
restricted to closed cab tractors and the maximum application rate on sorghum is reduced. For
the Counter 20CR open bag product, risk concerns on sorghum can also be mitigated to an
acceptable level if there is a reduction in the maximum application rate. The Agency also has
risk concerns for workers using the Counter 20CR product in open bags under a Special Local
Need (SLN) registration in North Carolina which allows use on corn at twice the maximum
application rate of the Section 3 registration. The Agency has determined that this risk concern
can be mitigated to an acceptable level if North Carolina revises the SLN registration to permit
use of Counter 20CR in closed loading systems only (i.e., "Lock-N-Load" packaging).
EPA does not believe there is a significant potential for post-application exposures to
terbufos based on application methods, timing, and frequency. The Agency concludes that the
48 hour Restricted Entry Interval (REI) established under EPA's Worker Protection Standards
(WPS) is sufficient to protect workers who may re-enter treated areas. 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 uses of terbufos may continue.
Ecological Risk
Ecological risks to terrestrial and aquatic organisms are of concern to the Agency. The
Agency is concerned about potential adverse effects to terrestrial and aquatic organisms, based
on the Agency's assessment and fish kills associated with the use of terbufos on corn. Aquatic
incidents reported to EPA indicate that terbufos is the leading cause offish kills among
pesticides applied to corn, and is fourth in causing fish kills for any pesticide applied to any crop.
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The Agency has determined that these risks can be reduced by implementing limitations
on sales of terbufos and adding buffers to the labels. The registrant has agreed to a phased
approach that will ultimately reduce sales of terbufos by 55% by 2008 based on 2000 sales
figures. By reducing the total amount of terbufos available to be applied, the Agency expects
that risks to aquatic and terrestrial organisms will be reduced.
The buffers to be implemented are; 1) a 500 ft. vegetative buffer between treated area and
surface water on neighboring land, 2) a 500 ft. vegetative buffer between a standpipe drain outlet
and surface water on neighboring land, 3) a 66 ft. setback between the treated area and entry
points to surface water bodies on non-highly erodible soils and 300 ft. on highly erodible soils,
4) a 66 ft. setback between treated area and standpipes on terraced fields as well as 66 ft.
vegetative buffer between the tile outlet and surface water bodies, and 5) restricting loading,
rinsing, and washing equipment within 300 ft. from surface water bodies or within 50 ft. from
wells unless conducted on an impervious surface. All setbacks must be planted to a crop or
seeded with grass or other suitable cover.
In addition, the registrant has agreed to voluntarily remove from its labels the "over the
top" application on corn for European corn borer control. Banded applications on corn will also
require placing granules in a 7 inch band over the row, in front of the press wheel, and
incorporated into the soil to a depth of 1 inch. To prevent the flow of rainfall down planted
rows, the label text will read "To prevent channeling of surface water run-off, adjust the planter
row-cleaners appropriately to prevent rows lower in height than adjacent soil".
Benefits
The benefits of terbufos on corn were estimated using a comparative product
performance assessment. This assessment aimed at quantifying, to the extent possible, the
benefits derived from the use of terbufos on corn primarily for control of corn rootworm. It
relied on data from numerous product performance studies available in the open scientific
literature. These data were analyzed using statistical methods to determine the relative effects on
corn yields of using terbufos and other corn insecticides especially tefluthrin. The benefits
assessment concluded that under most conditions the alternative insecticides produced similar or
greater yields than fields where terbufos was used. Terbufos did show an advantage over the
alternatives in controlling billbugs in North Carolina and controlling corn rootworm in the
Northeast. Terbufos also performed more effectively on some secondary corn pests. However,
there are uncertainties associated with the assessment that were taken into consideration when
developing the risk management measures outlined in the IRED.
For the uses of terbufos the Agency has determined that, with the adoption of all of the
label amendments noted in this document, use 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
terbufos, as announced in a Notice of Availability published in the Federal Register. This
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interim RED document includes guidance and time frames for complying with any necessary
label changes for products containing terbufos. There is a 60-day public comment period for this
document to allow stakeholders the opportunity to review and provide comments on this
document. 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 reregi strati on eligibility decision for terbufos can be
considered final, however, until the cumulative risks for all organophosphate pesticides are
considered. The cumulative assessment may result in further required risk mitigation measures
for terbufos.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on 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
reregi strati on 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"). Reregi strati on involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on health and environmental effects;
and to determine whether the pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment of all existing tolerances. The
Agency had decided that, for those chemicals that have tolerances and are undergoing
reregi strati on, the tolerance reassessment will be initiated through this reregi strati on process. 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. Terbufos 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 reregi strati on process, it does not amend any of the existing reregi strati on
deadlines. Therefore, the Agency is continuing its reregi strati on program while it resolves the
remaining issues associated with the implementation of FQPA.
This document presents the Agency's revised human health and ecological risk
assessments; its progress toward tolerance reassessment; and the interim decision on
reregi strati on eligibility for terbufos. It is intended to be only the first phase in the reregi strati on
process for terbufos. The Agency will eventually proceed with its assessment of the cumulative
risk of the OP pesticides and issue a final reregi strati on eligibility decision for terbufos.
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
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• Refining Dietary (Food) Exposure Estimates
• Refining Dietary (Drinking Water) Exposure Estimates
• Assessing Residential Exposure
Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides
with a Common Mechanism of Toxicity
Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving
and in a different stage of refinement. Some issue papers have already been published for
comment in the Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued,
on Sept. 29, 2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from organophosphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may
be exposed to organophosphate pesticides, and the Agency expects that other types of chemicals
will be handled similarly. Generally, basic protective measures such as closed mixing and
loading systems, enclosed cab equipment, or protective clothing, as well as increased reentry
intervals will be necessary for most uses where current risk assessments indicate a risk and such
protective measures are feasible. The policy also states that the Agency will assess each
pesticide individually, and based upon the risk assessment, determine the need for specific
measures tailored to the potential risks of the chemical. The measures included in this interim
RED are consistent with the Worker Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC
for public comment on science policy issues for the organophosphate pesticides and the worker
risk management PR notice. Section II provides a profile of the use and usage of the chemical.
Section III gives an overview of the revised human health and environmental effects risk
assessments resulting from public comments and other information. Section IV presents the
Agency's interim reregistration eligibility and risk management decisions. Section V
summarizes required label changes based on the risk mitigation and risk reduction measures
outlined in Section IV. Section VI provides information on how to access related documents.
Finally, the Appendices lists Data Call-In (DCI) information. The revised risk assessments 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.
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II. Chemical Overview
A. Regulatory History
Terbufos was first registered in the United States in 1974 by EPA for use as a systemic
insecticide-nematicide on corn. Registrations for the use of terbufos on sugar beets and sorghum
followed in 1976 and 1982, respectively. A Registration Standard was issued in 1983 and, in
1988, a Revised Registration Standard was issued for terbufos requiring numerous studies to
support continued registration. The 1983 Registration standard was amended in February 1985
to require Restricted Use classification due to acute oral and dermal toxicity. Two Preliminary
Notifications (i.e., Grassley-Allen letters) were sent to the technical registrant, in 1988 and 1990,
identifying terbufos as a candidate for Special Review based on risks to nontarget organisms;
birds, mammals, aquatic species, and endangered species.
B.
Chemical Identification
Chemical Structure of Terbufos:
s
-S CH2 S C(CH3)3
• Common Name:
• Chemical Name:
• Chemical family:
• CAS registry number:
• OPP chemical code:
• Empirical formula:
• Molecular weight:
• Trade and other names:
• Basic manufacturer:
Terbufos
S-[[l,l-dimethylethyl) thio] O,O-di-ethyl
phosphorodithioate
Organophosphate
13071-79-9
105001
C9H21O2PS3
288.4
Counter®
BASF Corporation (technical registrant)
-------
Technical terbufos is a colorless to pale yellow clear liquid with a mercaptan-like odor.
It has a boiling point of 55 °C at 0.02 mm Hg, and a density of I.II g/rnl at 20 °C. The
solubility of terbufos in water at 25 °C is 5.4 ppm. Its solubility in acetone, acetonitrile,
benzene, chloroform, dichloromethane, ethanol, n-heptane, methylene chloride, and toluene is
reported as > 100 g/100 ml at 20 °C. Water solubilities of the two major soil/water degradates at
25 °C are 3214 mg/L and 407 mg/L for terbufos sulfoxide and terbufos sulfone, respectively.
C. Use Profile
The following information is based on the currently registered uses of terbufos.
Type of Pesticide: Systemic insecticide-nematicide
Summary of Use Sites:
Food: Terbufos is applied at-plant/at-bedding, post emergent, or at cultivation to
control many types of insect pests. Registered use sites are corn (field, sweet, and
pop), sugarbeets, and grain sorghum. Approximately 80 percent of terbufos is
applied to field corn. Terbufos is also used on imported bananas grown in South
America and Mexico.
Residential: None.
Public Health: None.
Other Nonfood: None.
Target Pests: Target pests include corn rootworms, wireworms, white grubs,
billbugs, sugarbeet root maggots, cutworms, and nematodes.
Formulation Types Registered: In addition to the technical, there are two end-
use formulations registered: a clay-based granular formulation and a polymeric
granular formulation.
Method and Rates of Application:
Equipment - Granular row planters; in front of planter's press wheel with
light soil incorporation using, for example, drag chains, tines, or
cultivators.
Method and Rate - Applied 1) at-plant/at-bedding (banded, in-furrow,
knifed-in); 2) post emergent (banded alongside plant); and 3) at
cultivation. All applications require soil incorporation.
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• The typical application rate for corn is 1.0 Ib a.i./A, and the
maximum application rate for corn is 1.3 Ibs a.i./A, applied one
time per year. A Special Local Need (SLN) registration in North
Carolina allows use on corn at up to 2.6 Ibs a.i./A, one time per
year.
The typical application rate for sugarbeets is 1.3 Ibs a.i./A and for
sorghum is 0.7 Ibs a.i./A, both limited to one application per year.
The maximum application rate on these crops is 1.96 Ibs a.i./A,
applied one time per year.
Timing - At-plant/at-bedding, post-emergent, at-cultivation
Use Classification: The registered terbufos end-use products are restricted use
products due to acute oral and dermal toxicity.
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of
terbufos, based on available pesticide usage information for 1987 to 1996. A full listing of all
uses of terbufos, 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
7.5 million pounds of Terbufos a.i. are used annually, according to Agency estimates.
Table 1. Terbufos Estimated Usage
Crop
Corn (field, pop)
Sugar Beets
Sorghum
Sweet Corn
Lbs. Active
Ingredient Applied
(Wt. Avg.)1
6,530,000
670,000
190,000
55,000
Percent Crop
Treated (Likely
Maximum)
10%
43%
4%
6%
Percent Crop
Treated (Wt. Avg.)
8%
35%
2%
5%
1 Weighted Average is based on data for 1987-1996; the most recent years and more reliable data are weighted more
heavily.
The registrant has provided the Agency with proprietary domestic sales figures for 2000.
It should be noted that while these figures are significantly lower than the Agency estimates
presented in the table above, the proportions among the crops are comparable.
III. Summary of Terbufos Risk Assessments
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Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide terbufos, as fully presented in the documents,
"Terbufos, Human Health Risk Assessment" dated September 2, 1999, and "Terbufos, Revised
EFED Reregi strati on Eligibility Decision (RED) Chapter," dated August 26, 1999. 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 terbufos were presented at a September 2, 1999, Technical
Briefing, which was followed by an opportunity for public comment on risk management. The
risk assessments presented here form the basis of the Agency's interim risk management
decision for terbufos only; the Agency must consider cumulative risks of all the
organophosphate pesticides before any final decisions can be made.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for terbufos in August 1998 (Phase 3 of the
TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessments were refined and updated. Major revisions to the human health risk assessment are
listed below:
Use of new acute and subchronic oral rat neurotoxicity studies in the acute and chronic
dietary risk assessments.
- Reduction of the FQPA Safety Factor from 3X to IX, based on reevaluation of the hazard
and exposure database, including the new acute and subchronic oral rat neurotoxicity
studies.
Use of new corn and banana residue field trial studies in the acute and chronic dietary
risk assessments, in combination with previously submitted field trial data.
- Use of new chemical specific worker exposure studies and formulation-specific 28-day
rat dermal toxicity studies in the occupational risk assessment.
- Use of separate toxicological endpoints for dermal and inhalation exposures for the
occupational assessment.
Use of the SCI-GROW and PRZM-EXAMS models and new aquatic metabolism data to
estimate potential environmental concentrations (EECs) of terbufos in drinking water
through groundwater and surface water.
1. Dietary Risk from Food
a. Toxicity
10
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The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database is sufficiently complete, and that it supports an interim reregi strati on eligibility
determination for all currently registered uses. Further details on the toxicity of terbufos can be
found in the September 2, 1999 Human Health Risk Assessment. A brief overview of the studies
used for the dietary risk assessment is outlined in Table 2 in this document.
b. FQPA Safety Factor
The FQPA Safety Factor was reduced to a IX. Based on a weight-of-the-evidence
evaluation of the hazard and exposure database for terbufos, there is no indication of increased
susceptibility of young rats or rabbits to terbufos. Therefore, the additional 10X factor as
required by FQPA was reduced to IX. Terbufos did not cause acute delayed neurotoxicity in
hens given a single oral dose of terbufos, and there was no evidence of neuropathology in the
acute, subchronic, and chronic studies in dogs or a long-term mouse study. The toxicity database
includes acceptable acute and subchronic neurotoxicity studies in rats, which were data gaps
previously. In the rat acute neurotoxicity study, no effects were observed on motor activity, but
several functional observational battery (FOB) parameters (e.g., ataxia, decreased forelimb grip
strength, tremors) were affected. No treatment-related effects were observed on motor activity
or in the FOB parameters measured in the rat subchronic neurotoxicity study. In the
developmental and reproduction studies, effects were observed in fetuses/offspring only at or
above treatment levels, which resulted in evidence of parental toxicity. The dietary food
exposure assessment does not underestimate potential exposures to infants and children from
terbufos residues in food. No exposure is expected to infants and children from residential (non-
occupational) sources because terbufos is only registered on three agricultural crops.
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human
Dietary Risk Assessment for Terbufos.
Exposure
Scenario
Acute
Dietary
Chronic
Dietary
Dose
(mg/kg/day)
NOAEL =
0.15
NOAEL =
0.005
Endpoint
Plasma ChE
inhibition in
both sexes and
clinical signs.
Plasma ChE
inhibition in
both sexes.
Study
Acute Oral
Neurotoxicity in Rats
(MRID 44672003)
Chronic 1-year and
subchronic oral
toxicity in dog (MRIDs
00263678, 40374701)
UF
500
100
FQPA
Safety
Factor
IX
IX
PAD
(mg/kg/day)
0.0003
mg/kg/day
0.00005
mg/kg/day
11
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c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical, and reflects the
Reference Dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA
safety factor (i.e., RfD/FQPA safety factor). A risk estimate that is less than 100% of the acute
or chronic PAD does not exceed the Agency's risk concern. The RfD is calculated by taking the
no observed adverse effect level (NOAEL) from an appropriate toxicity study and dividing it by
an uncertainty factor (UF) (i.e., NOAEL/UF). In the case of terbufos, the FQPA safety factor is
IX; therefore, the RfD equals the PAD.
The acute PAD for terbufos is 0.0003 mg/kg/day (0.15 mg/kg/day/500) based on plasma
ChE and clinical signs observed in the acute rat neurotoxicity study. The UF of 500 is calculated
as follows: 10X for interspecies extrapolation x 10X for intraspecies variability x 5X for
differences in sensitivity between rats and dogs. The additional UF of 5X is required based on
an analysis of plasma ChE in the rat subchronic neurotoxicity study and a 28-day oral toxicity
study in dogs. The analysis was performed to determine a species sensitivity factor that would
be appropriate to apply to the rat acute neurotoxicity study. Previously, EPA had selected results
from the 28-day dog toxicity study for the acute endpoint, which had a plasma ChE measurement
at day 7. Using the rat acute neurotoxicity study for the endpoint with a derived species
sensitivity factor provides the appropriate time-related endpoint and takes into account the
observed sensitivity between the rat and dog.
The chronic PAD for terbufos is 0.00005 mg/kg/day (0.005 mg/kg/day - 100) based on
plasma ChE observed in a 28-day oral toxicity study in dogs (NOAEL = 0.005 mg/kg/day) and a
1-year oral toxicity study in dogs.
d. Exposure Assumptions
Revised acute and chronic dietary risk analyses for terbufos 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 acute dietary analysis uses anticipated residue values from crop residue field trial
studies, and percent crop-treated figures. The chronic dietary analysis was refined using
anticipated residue values from crop residue field trial studies, and weighted average percent
crop treated figures. The dietary exposure analyses for terbufos are based largely on residue
values from field trial data below the limit of detection (LOD), between the LOD and limit of
quantitation (LOQ), or at the LOQ. The Agency considered using monitoring data from
USDA's Pesticide Data Program (PDF) and FDA enforcement monitoring data available for
terbufos on bananas and sweet corn, but determined that these data are not appropriate for use in
this risk assessment for several reasons, including that the monitoring effort did not measure all
the terbufos degradates of concern. It should also be noted that exposure from coffee beans
treated with terbufos was included in the dietary assessment because a proposal to extend the
time-limited tolerance for that commodity is currently pending.
12
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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 EPA's risk concerns. The terbufos acute dietary risk
from food alone is below the Agency's level of concern—that is, less than 100% of the acute
PAD is used. For example, for the most exposed subgroups, non-nursing infants and infants (< 1
year), the percent acute PAD values are 86% and 82%, respectively, at the 99.9th percentile of
exposure from consumption of food alone.
The chronic dietary risk from food alone is well below the Agency's level of concern.
For the most exposed subgroups, infants, the percent chronic PAD values are no more than 9%.
Both the acute and chronic dietary exposure and risks associated with terbufos are below
the Agency's level of concern. To further characterize acute dietary risk, additional analysis
were conducted indicating that bananas are the most significant contributor to the estimated
acute dietary risk from food alone. Both the acute and chronic dietary risk assessments are
considered to be refined using the data available. However, the acute and chronic analyses do
not take into consideration the potential for reduction or concentration of terbufos residues in
cooked/canned/processed bananas and sweet corn, since there are no chemical-specific cooking
studies available. EPA could refine the terbufos dietary exposure analysis if these data were
generated and could be further refined if appropriate monitoring data were available. It should
be noted that the available PDF monitoring data, while not appropriate for the purposes of
quantitative risk assessment, found no detections of terbufos or terbufos sulfone residues in over
100 samples of sweet corn. Any and all available refinements will be considered when the
cumulative assessment for all of the organophosphates is conducted.
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.
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.
In the case of terbufos, EPA is concerned about the potential for parent terbufos and its
two major degradates in water, terbufos sulfoxide and terbufos sulfone, to runoff to surface water
sources, and the potential for these degradates to leach to groundwater sources. The PRZM-
EXAMS model was used to estimate surface water concentrations, and SCI-GROW was used to
estimate groundwater concentrations. Although some monitoring data for terbufos were
13
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available, these data were deemed of limited value for several reasons, including that the
degradates of concern were typically not included as part of the analyses. Further discussion
follows below regarding the monitoring data the Agency considered for terbufos. EPA also
reviewed and considered new environmental fate data submitted on the abiotic hydrolysis and
aerobic aquatic metabolism of parent terbufos and its degradates.
a. Surface Water
The Tier IIPRZM-EXAMS screening model is used to estimate upper-bound
environmental concentrations (EECs) in drinking water derived from surface water. This model,
in general, is based on more refined, less conservative assumptions than the Tier I GENEEC
screening model. Acute modeled EECs for terbufos parent and its degradates, terbufos sulfoxide
and terbufos sulfone, in surface water range from 5.4 ppb to 13.3 ppb, depending on the crop
site. Chronic modeled EECs for terbufos parent and its degradates range from 1.3 ppb to 5.5
ppb, depending on the crop site.
The Agency also used the recently implemented Index Reservoir (IR) and Percent Crop
Area (PCA) modifications to the Tier II PRZM-EXAMS model to calculate upper-bound EECs
for terbufos and its degradates in drinking water derived from surface water. Applying the IR
and PCA modifications, acute modeled EECs for terbufos parent and its degradates, terbufos
sulfoxide and sulfone, in surface water range from 8.4 ppb to 25.5 ppb depending on the crop
site. Chronic modeled EECs for terbufos parent and its degradates, terbufos sulfoxide and
sulfone, range from 1.8 ppb to 5.9 ppb, depending on the crop site.
The surface water model assumes terbufos applications are made at the maximum rate for
each crop on the current label, using the labeled methods of application (i.e., T-banded, in-
furrow, or knifed-in). In addition, the Agency applied the standard assumption that 85 percent of
the applied end-use product granules would be found in the top two cm of the soil. Finally, half-
life inputs in the model were derived using direct measurements of terbufos parent and its
degradates from aerobic aquatic metabolism data (MRID 44862502), rather than default or
"worst-case" assumptions, which provides additional refinement to the terbufos modeling.
Monitoring for terbufos in surface water is limited and has been undertaken by U.S.
Geological Survey (USGS) in its National Water Quality Assessment (NAWQA) program and
by some states. Terbufos parent was not found above 2.25 ppb in monitoring data. The Agency
believes that the terbufos monitoring data available are limited and often not associated with
periods of terbufos use. For instance, samples were often taken throughout the year rather than
concentrating sampling during the time period when terbufos application is expected.
Furthermore, the degradates of concern, terbufos sulfoxide and sulfone, were not included in any
of the analyses. Given these limitations, the existing surface water monitoring database cannot
be used to estimate concentrations of terbufos in surface water. However, the Agency notes that
the available NAWQA data found 17 detections of parent terbufos in 5,198 samples. The
detections ranged from 0.013 ug/L to 0.56 ug/L.
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b. Ground Water
The Tier I screening model, SCI-GROW, was used to estimate drinking water
concentrations derived from groundwater. Acute and chronic EECs for terbufos parent and its
degradates, terbufos sulfoxide and sulfone, in groundwater range from 4.8 ppb to 7.4 ppb. The
groundwater modeling assumes applications are made at the maximum rate for each crop on the
current label, using the labeled methods of application (i.e., T-banded, in-furrow, or knifed-in).
The half-life inputs in the model are derived from direct measurements of terbufos parent and its
degradates from an aerobic soil metabolism study (MRID 00156853).
Monitoring of groundwater supplies for terbufos has been limited. Information on
terbufos in groundwater has been gathered by the registrant, USGS NAWQA, EPA's Pesticides
in Groundwater Database, and some states within the major use areas. These data represent
4,563 samples from 13 states, including 20 detections of parent terbufos with an additional 7
apparent detections in Iowa that are questionable or unconfirmed. Thirteen wells were also
sampled in Iowa for terbufos sulfone, but no residues were detected. Detections of Terbufos
parent in groundwater studies has ranged from 0.011 ppb up to 20.0 ppb. However, only two
detections were about 0.06 ppb. EPA has determined that the groundwater monitoring data
available to the Agency are inadequate for use in assessing groundwater exposures for several
reasons, including that the monitoring studies did not analyze for the degradates of concern.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by
food (and if appropriate, residential uses) then determines a "drinking water level of
comparison"(DWLOC) to determine whether modeled or monitoring levels exceed this level.
The Agency uses the DWLOC as a surrogate to capture risk associated with exposure from
pesticides in drinking water. The DWLOC is the maximum concentration in drinking water
which, when considered together with dietary exposure, does not exceed a level of concern.
The results of the Agency's drinking water analysis are summarized here. Details of this
analysis, which used screening models, are found in the HED Human Health Risk Assessment
dated September 2, 1999 and the EFED Environmental Risk Assessment dated August 26, 1999.
For acute risk, groundwater and surface water EECs exceed the acute DWLOCs for
infants and children (Table 3). Even if it is assumed that there are no food exposures to terbufos,
drinking water alone, based on model estimates, would result in exceedences of the risk cup,
particularly for infants and children. The table below presents the calculations for the acute
drinking water assessment.
Table 3. Summary of DWLOC Calculations for Acute Risk
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Population
Subgroup
U.S.
Population
Non-
nursing
Infants
(<1 yr)
All Infants
(<1 yr)
Children
(1-6 years)
Children
(7-12
years)
Acute PAD
(mg/kg/day)
3.0e-4
3.0e-4
3.0e-4
3.0e-4
3.0e-4
Food
Exposure
(mg/kg/day)
7.0e-5
2.6e-4
2.5e-4
1.4e-4
6.9e-5
Allowable
Water
Exposure
(mg/kg/day)
2.3e-4
4.1e-5
5.0e-5
1.6e-4
2.3e-4
Maximum
Groundwater
EECs (SCI-
GROW, total
toxic residue,
ppb)
7.4
7.4
7.4
7.4
7.4
Maximum
Surface Water
EECs (PRZM/
EXAMS, total
toxic residue,
ppb)
13.3
13.3
13.3
13.3
13.3
Maximum
Surface Water
EECs (PRZM/
EXAMS, IR &
PCA
modifications,
total toxic
residue, ppb)
25.5
25.5
25.5
25.5
25.5
DWLOC
(ppb)
8.10
0.41
0.50
1.60
2.30
For chronic risk, groundwater and surface water EEC's exceed the chronic DWLOC's for
all population subgroups, regardless of the treated crop (Table 4). Even if it is assumed that
there are no food exposures to terbufos, drinking water alone, based on model estimates, would
result in exceedences of the risk cup, particularly for infants and children. The table below
presents the calculations for the chronic drinking water assessment.
16
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Table 4. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S.
Population
Non-
nursing
infants
(<1 yr)
All Infants
(<1 yr)
Children
(1-6 years)
Children
(7-12
years)
Chronic
PAD
(mg/kg/day)
5.0e-5
5.0e-5
5.0e-5
5.0e-5
5.0e-5
Food
Exposure
(mg/kg/day)
l.Oe-6
5.0e-6
4.0e-6
2.0e-6
l.Oe-6
Allowable
Water
Exposure
(mg/kg/day)
4.9e-5
4.5e-5
4.6e-5
4.8e-5
4.9e-5
Maximum
Groundwater
EECs ( SCI-
GROW, total
toxic residue,
ppb)
7.4
7.4
7.4
7.4
7.4
Maximum
Surface Water
EECs (PRZM/
EXAMS, total
toxic residue,
ppb)
5.5
5.5
5.5
5.5
5.5
Maximum
Surface Water
EECs (PRZM/
EXAMS, IR &
PCA
modifications,
total toxic
residue, ppb)
5.9
5.9
5.9
5.9
5.9
DWLOC
(ppb)
1.70
0.45
0.46
0.48
0.49
The acute and chronic dietary risks from drinking water exposure are above the Agency's
level of concern for most subpopulations. However, there are uncertainties which lead the
Agency to expect that exposure from drinking water may not be as high as the levels used in the
development of the risk assessment. These uncertainties are described in Section IV.
3. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes). Acute and chronic aggregate risk assessments were conducted for
terbufos. Since terbufos is not registered for use in residential settings, residential exposures are
not expected, and aggregate short- and intermediate-term exposures were not estimated. Results
of the aggregate risk assessment are summarized here, and are discussed in the terbufos human
health risk assessment.
The Agency was only able to quantify food sources of dietary exposure to terbufos
because dietary exposures through drinking water have only been estimated using models.
Neither adequate groundwater or surface water monitoring data were available to estimate
potential drinking water exposures to terbufos and its degradates.
Acute Aggregate Risk Assessment: Potential acute dietary risks from food sources alone
do not exceed the Agency's level of concern. The most exposed subpopulation, non-nursing
infants, consume 86% of the acute PAD at the 99.9th percentile of exposure, based on highly
refined exposure estimates. However, when drinking water exposure concentrations, derived
17
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from groundwater and surface water models, are added to the acute dietary risk assessment, the
potential exists for acute dietary exposures through drinking water that exceed the acute
DWLOCs, resulting in acute aggregate risks of concern.
Chronic Aggregate Risk Assessment: In the case of the food component of the chronic
aggregate risk assessment, risks are well below the Agency's level of concern. No more than 9%
of chronic PAD is consumed for infants. However, based on modeled estimates of terbufos
concentrations in groundwater and surface water, the potential exists for chronic dietary
exposures through drinking water that exceed the chronic DWLOCs, resulting in chronic
aggregate risks of concern.
4. 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. Terbufos is not registered for use in residential
settings so homeowner or non-occupational exposures are not expected. Occupational handlers
of terbufos include individual farmers or growers who load and/or apply pesticides, and
professional or custom agricultural applicators. Risk for all of the potentially exposed
populations is measured by a Margin of Exposure (MOE) which determines how close the
occupational exposure comes to a No Observed Adverse Effect Level (NOAEL). Generally,
MOEs greater than 100 are considered to not exceed EPA's risk concern.
a. Toxicity
The toxicity of terbufos is integral to assessing the occupational risk. All risk
calculations are based on the most current toxicity information available for terbufos including a
28 day dermal toxicity study. The toxicological endpoints, and other factors used in the
occupational risk assessment for terbufos are listed below in Table 5a. The endpoints selected
for the dermal and inhalation risk assessments have been applied to both short-term and
intermediate-term exposure scenarios.
18
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Table 5a. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessments for terbufos
Assessment
Short-term and
Intermediate-
Term dermal
Short-term and
Intermediate-
term inhalation
Dose
Counter 15G: NOAEL
= 0.32 mg/kg/day
Counter CR: NOAEL =
2.0 mg/kg/day
NOAEL = 0.0035
mg/kg/day2
Endpoint
plasma and
brain ChE
inhibition
plasma and
RBCChE
inhibition
Red blood cell,
plasma, and
brain ChE
inhibition
Study
28-day dermal toxicity study in
rats using Counter 15G (MRID
44520501)
28-day dermal toxicity study in
rats using Counter CR (MRID
44690501)
90-day subchronic inhalation
study in rats (MRID 00258710)
Absorption
factor
NA1
100%
'A dermal absorption factor is not required for terbufos since product-specific data were available from two dermal
toxicity studies.
Calculated as follows: 0.00001 mg/L x 100% absorption x 43.5 L/hr/kg for rat strain x 8 hour duration x 1 activity
factor = 0.0035 mg/kg/day.
In acute toxicity studies, terbufos exhibits severe acute toxicity via the oral, dermal, and
inhalation routes of exposure (Table 5b). Terbufos is also considered to be a severe eye and
dermal irritant, although dermal and eye irritant assessments were not possible due to death of all
test animals within 24 hours of exposure in the eye and dermal irritation studies. The dermal
sensitization study was waived due to lethality.
Table 5b. Acute Toxicity Profile for Occupational Exposure for terbufos
Route of
Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal
Irritation
Dermal
Sensitizer
Toxicity
Category
I
I
I
I
I
NA
Category Basis
LD50 < 50 mg/kg
LD50 < 200 mg/kg
LC50 < 0.05 mg/L
Corrosive
Corrosive
NA
Study Type and Results
Acute oral toxicity study in rats,
LD50* 1.5 rag/kg
Acute dermal toxicity study in rabbits,
LD50 = 0.87 mg/L males and females
Acute inhalation study in rats,
LC50= 1.7,wg/L
Primary eye irritation study in rabbits,
all animals died within 24 hrs of exposure
Primary skin irritation study in rabbits,
all animals died within 24 hrs of exposure
Waived due to lethality
MRID No.
00029863
00258710
41538101
00044957
00044957
NA
b. Exposure
19
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Two chemical- and scenario-specific occupational exposure studies were submitted to
support the terbufos reregi strati on:
1) Exposure of farm workers to terbufos while loading Counter 15G with a Lock-N-
Load closed handling system and applying Counter 15G to corn at planting time
(closed cab applications) (MRID 44793301, Exhibit 1).
2) Exposure of farm workers to terbufos while loading Counter CR from open bags
and applying to corn at planting time (open cab applications) (MRID 44793301,
Exhibit 2).
In addition, a method validation study (MRID 44793301) was submitted to establish the
parameters for the analytical methods used in the occupational exposure studies. These studies
were reviewed and accepted by the Agency, and are being used in the terbufos occupational risk
assessment. The Agency also used the Pesticide Handlers Exposure Database (PHED) for risk
characterization purposes to evaluate occupational risks at reduced levels of personal protection
and engineering controls.
Generally, results from the occupational exposure studies indicate low exposures to
loaders and applicators when using high levels of PPE and closed loading. Terbufos was not
detected in many of the exposure scenarios for which it was monitored in the studies. A large
percentage of the exposure values were either below the limit of detection (LOD) or limit of
quantification (LOQ). Figures used to calculate unit exposure values in these cases were !/2 the
LOD or LOQ. Refer to the occupational risk assessment dated August 26, 1999, for additional
information on results from these two studies.
When conducting occupational risk assessments, EPA usually combines chemical-
specific data with PHED data to obtain a more robust data set. The terbufos worker exposure
studies, however, have not been integrated with PHED because the Agency believes physical
differences in the formulations and packaging preclude combining the data with PHED. The
terbufos studies are also unique because they represent a slightly higher level of personal
protection than is typically considered using PHED. In the study, an enclosed cab was used for
application with the windows open in an attempt to simulate open cab conditions. In PHED,
applicators in an enclosed cab only wear baseline PPE, however, in this study, applicators wore
maximum personal protective equipment.
The Agency uses a concept known as unit exposure as the basis for job scenarios used to
assess occupational exposures to pesticides. Unit exposures represent the estimated exposures a
pesticide handler would receive when making a particular application. EPA has developed a
series of unit exposures unique to each type of job scenario in PHED. For terbufos, unit
exposures were calculated by the registrant from the occupational exposure studies representing
the minimum, maximum, and geometric mean values. These values have been verified by the
Agency, and are being used in the risk assessment to represent typical to maximum exposures.
The geometric mean values (a measure of the central tendency of the data) are the closest
20
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approximation of the unit exposure values, and are the values used to determine whether the
exposures exceed the Agency's level of concern.
Anticipated use patterns, application methods, and range of application rates were
derived from the current terbufos labeling. Application rates for crops specified on the terbufos
labeling range from 1.3 to 2.0 Ibs. a.i./A. A Special Local Need (SLN) registration in North
Carolina allows use on corn up to 2.6 Ibs a.i./A.
Because chemical- and scenario-specific occupational exposure studies are available for
terbufos, the combinations of engineering controls and personal protective equipment (PPE)
evaluated in the risk assessment are slightly different than combinations typically considered by
the Agency. First, all Counter 15G is loaded using a Lock-N-Load, closed handling system,
whereas Counter CR formulation is available in both Lock-N-Load packaging and open bags.
Secondly, current terbufos labels require applicators and other handlers to wear coveralls over
long-sleeved shirt and pants, waterproof gloves, chemical-resistant footwear plus socks,
protective eye-wear, chemical-resistent headgear, a chemical-resistent apron, and a PF 10 APR
respirator. The levels of protection that form the basis for the terbufos exposure calculations are:
Baseline:
Minimum PPE:
Maximum PPE:
Engineering controls:
Long-sleeved shirt and long pants, shoes and socks. [Note:
This scenario was used only for exposure data developed
using the Pesticide Handlers Exposure Database]
Baseline + chemical resistant gloves and a dust/mist
respirator with a protection factor of 5. [Note: This scenario
was used only for exposure data developed using the
Pesticide Handlers Exposure Database]
Baseline + coveralls, chemical resistant gloves, and an air
purifying respirator with a protection factor of 10. [Note:
This scenario was used for exposure data developed using
the Pesticide Handlers Exposure Database and Counter 20
CR chemical- and scenario specific exposure monitoring
studies]
Engineering controls such as an enclosed cab tractor or
closed loading system for granulars. [Note: This scenario
was used only for exposure data developed using the
Pesticide Handlers Exposure Database]
Engineering controls + PPE: Engineering controls such as an enclosed cab tractor or
closed loading system for granulars with associated PPE
required by the WPS when engineering controls are used
(e.g., apron and chemical resistant gloves). [Note: This
scenario was used only for exposure data developed from
21
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the Counter 15 G chemical- and scenario specific exposure
monitoring studies]
A chemical can produce different effects depending on how long a person is exposed to
it, how frequently any exposures occur, and the level of exposure. For terbufos, EPA completed
occupational risk assessments for short- and intermediate-term duration, to reflect potential
exposures from 1-30 days up to several months. Some applicators may apply terbufos over a
period of weeks because they may need to cover large acreage, or they may be professional
applicators completing numerous applications within a region. A chronic risk assessment was
not conducted for terbufos because exposures of a chronic duration are not expected.
c. Occupational Handler Risk Summary
In the revised risk assessment, risks to handlers has been assessed using separate
toxicological endpoints for both dermal and inhalation exposures because the dose levels at
which effects occur differ depending on whether terbufos was deposited on the skin or inhaled.
In addition, the Agency selected two sets of dermal endpoints to assess dermal exposures
because the physical nature of each formulated product has different impacts on dermal toxicity.
A single endpoint has been selected to assess inhalation exposures for both granular formulations
because only a single study was available. The resulting risks (MOE values) were then added to
obtain an overall risk for handlers that accounted for both dermal and inhalation exposures.
These endpoints are believed to be appropriate for both short- and intermediate-term risk
assessment. All the risk calculations for handlers completed in this assessment are included in
Appendix A of the Occupational and Residential Exposure (ORE) Chapter dated August 26,
1999.
Analyses were conducted to determine the MOEs at typical and maximum application
rates, and at typical and maximum acreage-treated for the different exposure scenarios. Each of
these analyses is included in Appendix A, Tables 1-14 of the ORE Chapter. The following
tables in this document, summarize the exposure scenarios at maximum application rates and
acreage-treated.
1) Agricultural Handler Risk
For terbufos, combinations of target crops, application rates, acreage treated, and worker
scenarios were assessed for short- and intermediate-term exposures for each of the end-use
products. The Agency has some remaining risk concerns for exposure scenarios assessed for the
Counter 15G and Counter 20CR formulations when used in a manner consistent with the
parameters in the occupational exposure studies.
Counter 15G is only available in closed system packaging (i.e., Lock-N-Load) according
to the registrant, and therefore the Agency did not assess other types of packaging for the
product. The registrant used the occupational exposure study for Counter 15G, which was
conducted using tractors with enclosed cabs and open windows, to extrapolate to an open cab
application exposure scenario. The Agency does not believe this is a valid approach for
22
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assessing open cab exposures for Counter 15G given the study's reliance on unrefined protection
factors and since empirical data exist in PHED for this scenario. Instead, the Agency used this
data to assess exposures for closed cabs scenarios even though the registrant believes the study
represents open cab conditions. Current labels do not require the use of an enclosed cab during
application. The occupational exposure study for Counter 20CR was conducted with open bag
packaging and open cabs.
Based on the PHED data (maximum PPE), the Agency has risk concerns for loading and
applying Counter 15G (Table 6). However, based on the chemical specific study, the Agency
has risk concerns only for loading Counter 15G (Table 6). This study determined that applying
15G with a closed cab is not of concern.
The Counter 20CR formulation is available in open bag packaging and closed (Lock-N-
Load) packaging. For Counter 20CR in open bag and open cab, the Agency also has risk
concerns for some exposure scenarios (Table 7). There are no risk concerns when the Counter
20CR formulation is used in closed systems (Lock-N-Load) and open or closed cabs.
All the MOEs in the tables below are based on combined dermal and inhalation MOEs.
The scenario numbers correspond to the scenario numbers detailed and discussed in Appendix A
of the ORE Chapter. The current labels do not require an enclosed cab for application of
terbufos. Thus the remaining risk concerns for Counter 15G are based on the chemical specific
study for loading and PHED data (maximum PPE). For Counter 20CR, the remaining risk
concerns are based on the chemical specific study. The scenarios with remaining risk concerns
are:
(Ib) Loading Counter 15G in closed system using the North Carolina SLN 2x
rate on corn, the maximum rate/acreage on sugar beets, and the maximum
rate/acreage on sorghum.;
(2b) Applying Counter 15G in open cabs (maximum PPE) using the maximum
rate/acreage on corn, the North Carolina SLN 2x rate on corn, the
maximum rate/acreage on sugar beets, and the maximum rate/acreage on
sorghum.;
(Ic) Loading Counter 20CR in open bags using the North Carolina SLN 2x
rate on corn, the maximum rate and acreage on sugar beets, the maximum
rate and acreage on sorghum.;
Table 6 describes the short- and intermediate-term MOEs derived from PHED and
chemical specific data for Counter 15G exposure scenarios. Table 7 describes the short- and
intermediate-term MOEs derived from the Agency's use of the chemical specific worker
exposure studies for Counter 20CR.
It is notable that inhalation exposures are driving the Agency's risk concern for the
occupational scenarios in question rather than dermal exposures. In addition, the risk concern
for handlers using Counter on corn is associated with a North Carolina Special Local Need
(SLN) registration. This use on corn is twice the labeled maximum rate (2.6 Ibs a.i./A).
23
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24
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Table 6. Counter 15G, Agricultural Uses: Completed using PHED and chemical specific
data, combined dermal & inhalation MOEs.
Scenario
(Ib) Loading
Counter 15G
formulation in
lock-n-load
containers
(2b) Applying
Counter 15G
Crop Type
Corn
Sugar Beets
Sorghum
Corn
Sugar Beets
Sorghum
Rate
1.3
2.6
2.6
1.96
1.96
1.96
1.7
1.3
2.6
1.96
1.96
Acres
213
213
150
213
130
213
213
213
213
213
213
Short-Term and Intermediate-Term MOEs
Maximum PPE (PHED
data)
4.3
2.1
n.c.2
2.8
4.6
2.8
n.c.
5.3
2.7
3.5
3.5
Eng. Controls (chemical
specific data1)
105.2
52.6
75
69.8
114
69.8
81
314.4
157.2
208.6
208.6
1 For loading- Chemical-resistant apron over long pants, long sleeve shirt, shoes, socks, chemical-resistant gloves.
For applying- Enclosed cabs
2 Not calculated
Table 7. Counter CR, Agricultural Uses: Completed using chemical specific data,
combined dermal & inhalation MOEs
Scenario
(Ic) Loading
Counter CR
Formulation in
Open Bags
(2c) Applying
Counter 20 CR
Crop Type
Corn
Sugar Beets
Sorghum
Corn
Sugar Beets
Rate
1.3
2.6
1.96
1.96
1.96
1.7
1.3
2.6
1.96
Acres
213
213
213
130
213
213
213
213
213
Short-Term and Intermediate-Term MOEs
Max. PPE1 without
respirator
13.0
6.5
8.6
n.c.3
8.6
n.c.
687.0
343.5
455.7
Max. PPE1 with respirator2
128.7
64.4
85.4
140
85.4
98
5752.0
2876.0
3815.1
25
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Scenario
Crop Type
Sorghum
Rate
1.96
Acres
213
Short-Term and Intermediate-Term MOEs
Max. PPE1 without
respirator
455.1
Max. PPE1 with respirator2
3815.1
1 For loading- Apron over long pants, long sleeve shirt, shoes, socks, and chemical-resistant gloves.
For applying- Coveralls over long pants, long sleeve shirt, shoes, socks, and chemical-resistant gloves.
2 Respirator = PF 10
3 Not calculated
2) Post-Application Occupational Risk
EPA does not believe there is a significant potential for post-application exposures to
terbufos based on application methods, timing, and frequency. In addition, the Agency does not
believe there is significant potential for drift into adjoining areas such as residential areas since
the product is soil incorporated in granular form using ground equipment only. Terbufos use in
residential areas is not permitted. Given these factors, the Agency concludes that the Restricted
Entry Intervals (REIs) established under EPA's Worker Protection Standards (WPS) are
sufficient to protect workers who may re-enter treated areas. The REI for areas treated with
terbufos is 48 hours and 72 hours in areas where average annual rainfall is less than 25 inches
per years.
B.
Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For a
detailed discussion on all aspects of the environmental risk assessment, see the Environmental
Fate and Effects Division chapter, dated August 26, 1999, available in the public docket, and
supporting documents dated August 20 and August 5, responding to comments from the
registrant and other stakeholders.
Several revisions have been made since the preliminary risk assessment was completed,
and include:
modifications to the ecological risk assessment and characterization, including an update
of the Agency's aquatic and terrestrial incident database, based on information supplied
by states, the registrant, and other stakeholders.
• consideration of new environmental fate data submitted on the abiotic hydrolysis and
aerobic aquatic metabolism of parent terbufos and its degradates.
revisions to the estimated concentrations of terbufos and its degradates in surface water
and groundwater using the PRZM-EXAMS and SCI-GROW models;
• use of index reservoir and percent crop area modifications to the PRZM-EXAMS
modeling, and the available environmental fate data for terbufos, to estimate terbufos and
its degradates in surface water used for drinking water.
26
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EPA has used the quotient method to evaluate potential risks to nontarget organisms from
use of terbufos. Applying this method, risk quotients (RQs) have been calculated by comparing
estimated concentrations of terbufos in the environment (or EECs) to results from ecological
toxicity studies in a variety of organisms. A finding of concern results when an RQ exceeds a
level of concern (LOG), which is a value calculated based on the category of nontarget organism
and category of concern. EPA has further characterized the ecological risk to nontarget
organisms for terbufos based on terrestrial field studies and adverse aquatic and terrestrial
incidents reported to the Agency associated with the use of terbufos on corn.
1. Environmental Fate and Transport
The environmental fate database for terbufos is mostly complete, and provides a
comprehensive understanding of terbufos fate and transport in the environment.
a. Degradation and Mobility
Based on a review of the environmental fate database for terbufos, total toxic residues of
terbufos (parent + degradates) are considered to be highly mobile and persistent. Hydrolysis and
microbial degradation are the primary dissipation processes for terbufos in the environment
when it is incorporated into the soil as required by the current label. The linear metabolic half-
life of parent terbufos in aerobic soil is approximately 27 days (5.6 days for non-linear). Under
abiotic (i.e., not biological) conditions, the hydrolysis half-life for parent terbufos is 12.3 to 13.7
days in the typical range of environmental pH values (pHs 5,7, and 9). Volatilization may be a
major dissipation route for the portion of parent terbufos that remains on the soil surface after
incorporation. The relatively high vapor pressure (3.16 x 10"4 mm Hg) and the observed Henry's
Law Constant (6.58 x 10"3) suggest that some parent material will dissipate by diffusion into the
atmosphere, but that the expected amount varies depending on site conditions and application
methods.
The metabolites of toxicological concern, terbufos sulfoxide and terbufos sulfone, are
more mobile and substantially more persistent than parent terbufos. Terbufos sulfoxide and
sulfone have non-linear half-lives in aerobic soil of 116 and 96 days, respectively. These
metabolites are also mobile in all tested soils with Freundlich Kads values ranging from 0.40 to
2.93, and may reach groundwater when terbufos is used in locations where irrigation or rain
water moves through the soil profile to groundwater. In addition, terbufos parent and its
metabolites may reach surface water sources as a result of runoff events.
In the case of terbufos, EPA is concerned about the potential for parent terbufos and its
two major degradates, terbufos sulfoxide and sulfone, to runoff to surface water sources, and the
potential for the degradates to leach to groundwater sources. The PRZM-EXAMS model was
used to estimate surface water concentrations, and SCI-GROW was used to estimate
groundwater concentrations. Although some monitoring data for terbufos were available, these
data were deemed of limited value for several reasons, including that the degradates of concern
were typically not included as part of the analyses.
27
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The data inputs used in the PRZM-EXAMS model were based on results from an aerobic
aquatic metabolism study in pond water for parent terbufos and the terbufos sulfoxide and
sulfone degradates (MRID 44862502). EPA used these data to determine the expected
persistence of parent terbufos and terbufos sulfoxide and sulfone in water, and the formation rate
of terbufos sulfone from applied sulfoxide. Terbufos parent degraded with a half-life of 1.5 days
using non-linear analysis in nonsterile pond water, and reached nondetectable levels by 7 days.
Applied terbufos sulfoxide degraded with a half life of 68 days and declined to 50-62 percent by
30 days (end of study). Applied terbufos sulfone degraded with a calculated half-life of 32 days
and declined to 39-43 percent by 30 days.
EPA did not use the results from the abiotic hydrolysis study (MRID 44862501) for
estimating concentrations of terbufos in surface water since the aerobic metabolism data were
deemed to be more relevant. However, for groundwater, the hydrolysis data provided useful
information on the persistence and degradation products in the event terbufos were to reach
groundwater sources.
b. Field Dissipation
The database for field dissipation is complete. The terrestrial field data submitted
indicate that terbufos dissipated in the field with half-lives of 24 days in sandy loam in
California, and 14-40 days in loamy and sandy loam soils in Illinois and Colorado. These half-
lives are comparable to findings from the aerobic soil metabolism study discussed above (half-
life 27 days). Data from the open scientific literature (Felsot, et al., 1987) reported half-lives of
11-16 days for parent terbufos and total toxic residue half-lives of 25-28 days in silt loam and
silty clay loam soils in the field when terbufos was applied at a rate of 1.0 Ib a.i./Acre.
2. Risk to Birds and Mammals
Terbufos presents high acute and chronic risks to non-target terrestrial wildlife species.
This is based on a weight of evidence evaluation from laboratory and field studies and adverse
incidents in the field, some of which were associated with misuse/misapplication. Granular
pesticides, such as the terbufos formulations, present a unique hazard to wildlife in that the
granules may be ingested directly by birds foraging for seed and grit at or below the soil surface.
Birds and mammals may also ingest granules adhered to the surface of invertebrate prey, such as
earthworms and grubs, or through ingestion of water or food sources contaminated with terbufos.
All currently registered uses of terbufos pose acute risks of concern based on the
Agency's standard LOG criteria. Acute RQs for avian species ranges from 1.3 to 32.0 and for
mammalian species from 2.2 to 327. The ranges provided reflect differences in the application
method and rate, and size of the bird or mammal. Both acute avian and mammalian risks exceed
the Agency's LOG of 0.5, indicating potential risks of concern to terrestrial organisms. Acute
RQs associated with banded applications tend to be greater than RQs calculated for other
application methods (e.g., in-furrow) due to less efficient soil incorporation. The database to
assess risk to birds and mammals is complete.
28
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3. Risk to Aquatic Species
The Agency is concerned about potential adverse effects to nontarget aquatic species,
based on the Agency's aquatic LOG assessment, which is strongly supported by fish kill
incidents associated with the use of terbufos on corn. No aquatic field studies are available. The
basis for the Agency's aquatic risk concern is summarized below. The database to assess risk to
aquatic species is complete.
a. Aquatic LOC Assessment
Acute and chronic RQs calculated for terbufos and its degradates exceed the Agency's
level of concern. Acute and chronic RQs that exceed the Agency's acute LOC of 0.5 and
chronic LOC of 1.0, respectively, are considered to be a risk concern. The acute RQs calculated
for terbufos and its degradates using banded applications range from 3-17 for fish, and 14-60 for
invertebrates. The chronic RQs calculated for terbufos and its degradates using banded
applications range from 2-8 for fish and 113-403 for invertebrates. The ranges in RQs are due to
the different application rates and EEC values for the crops.
The Agency's consideration of the total toxic residue of terbufos (parent + degradates)
raises the acute EECs and RQs by a factor of 2.5-3X, and raises the chronic EECs and RQs by a
factor of 15 - SOX. The greater increase for the chronic results may be due to the persistence of
the degradates. As indicated above, the surface water EECs calculated by the Agency are based
on measurements obtained from an aerobic aquatic metabolism study on terbufos parent and the
terbufos sulfoxide and sulfone degradates.
Note that for application methods other than banded, the Agency's estimated exposures
equal zero. However, fish kills associated with other methods of application (i.e., in-furrow) on
corn suggest that runoff can be associated with in-furrow applications to all three labeled uses,
corn, sugarbeets, and sorghum. The PRZM-EXAMS model used by EPA to estimate
concentrations of terbufos and its degradates in surface water may not adequately represent the
availability of the pesticide for runoff under all conditions.
b. Aquatic Incidents
Terbufos is the leading cause offish kill incidents reported to EPA for any pesticide
applied to corn, and ranks fourth in fish kill incidents reported to EPA for any pesticide applied
to any crop. From 1976 to present, 96 fish kill incidents involving terbufos have been reported
to the Agency, mostly by the registrant under FIFRA 6(a)(2), adverse effects reporting
requirements. A causal relationship between terbufos and fish kills has not been fully
established in all of the incidents.
The average rate of incidents is about 4 per year, although in any given year the number
of incidents reported can fluctuate broadly. For example, 3 incidents occurred in 2000; zero
incidents were reported for 1999, 4 in 1997, and 18 incidents were reported for 1990. The
Agency does not consider the aquatic incidents involving terbufos to be an exhaustive
29
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accounting of all the incidents. The following summarizes some other key points concerning the
incidents. Refer to the environmental assessment and addenda for additional details.
All the incidents reported to the Agency are associated with the corn use, involve
all methods of application, and both granular formulations (Counter 15G and
Counter CR).
• About 85 percent of the incidents to date have occurred in the midwest, corn belt
region (Iowa, Indiana, Illinois, Nebraska, Ohio). Some incidents have occurred in
North Carolina.
Most of the incidents occurred in static water bodies ("farm ponds") ranging in
size from 2 to 20 acres; some occurred in canals feeding into rivers.
Incidents generally occurred from 2 days to 3 weeks after application.
• Incidents were reported on property not owned by the applicator/farmer, in recent
cases, and involve reports of substantial economic loss, impacts to quality of life,
pet mortality, and concerns about health of people swimming in impacted lakes
and ponds.
Individual incidents indicate a broad range of mortality; from 30 up to 90,000 fish
mortalities. On average 3,600 mortalities were reported per incident based on
data from 1976 to 1998. Nineteen incidents reported greater than 1,000
mortalities.
• 51% of the incidents were defined as highly probable or probable where terbufos
and/or its degradates were identified from water analysis of impacted surface
water bodies or there was adequate information on the application of the
chemical. 46% of the incidents were defined as possible where either no water
analysis was conducted or the water was analyzed only for the parent. In many of
these instances terbufos was the only pesticide reported as being used
near/adjacent to the incident site. 3% of the incidents were due to misapplication.
• In a limited number of cases, in the early 1990's, it appears that pasture/grass
buffer strips or setbacks did not prevent incidents.
Most of the incidents appear to be associated with normal use.
• In some of the incidents, rainfall was reported as occurring over a period of days
to weeks prior to the incident. Based on the limited weather information
provided, the Agency believes the incidents could be associated with normal
spring rain events, as opposed to unusually severe rainfall events over a short
period of time.
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4. Endangered Species
The Agency has initiated three consultations with the Fish and Wildlife Service (FWS)
on the potential effects of terbufos corn use on endangered and threatened species. To date, the
FWS has issued two Biological Opinions. In these Opinions, the FWS found jeopardy for 13
fish species, 25 aquatic invertebrate species, and 4 insect species. An additional 15 fish species
and 2 aquatic invertebrate species were expected to be affected, but not jeopardized. The FWS
also found jeopardy for one avian species due to the potential effects of reducing its aquatic food
source. These consultations and the findings expressed in the Opinions, however, are based on
old labels and application methods, less refined risk assessment procedures, and an older
approach to consultation which is currently being revised through interagency collaboration.
EPA's current assessment of ecological risks uses both more refined methods to define
ecological risks of pesticides and new data, such as that for spray drift. Therefore, the
Reasonable and Prudent Measures (RPMs) in the Biological Opinion(s) may need to be
reassessed and modified based on these new approaches.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(l) of the Endangered Species Act. The
objective of this review is to clarify and develop consistent processes for endangered species risk
assessments and consultations. Subsequent to the completion of this process, the Agency will
reassess the potential effects of terbufos use to federally listed threatened and endangered
species. At that time, the Agency will also consider any regulatory changes recommended in the
RED that are being implemented. Until such time as this analysis is completed, the overall
environmental effects mitigation strategy articulated in this document and any County Specific
Pamphlets described below which address terbufos, will serve as interim protection measures to
reduce the likelihood that endangered and threatened species may be exposed to terbufos at
levels of concern.
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 reregi strati on. The Agency has previously identified and required the submission
of the generic (i.e., an active ingredient specific) data required to support reregi strati on of
products containing terbufos active ingredients.
The Agency has completed its assessment of the occupational and ecological risks
associated with the use of pesticides containing the active ingredient terbufos , as well as a
terbufos-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 terbufos, EPA has sufficient information on the
human health and ecological effects of terbufos to make an interim decisions as part of the
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tolerance reassessment process under FFDCA and reregistration under FIFRA, as amended by
FQPA. The Agency has determined that terbufos products are eligible for reregistration
provided that: (i) current data gaps and additional data needs are addressed; (ii) the risk
mitigation measures outlined in this document are adopted, and label amendments are made to
reflect these measures; and (iii) cumulative risks considered for the organophosphates support a
final reregistration eligibility decision. Label changes are described in Section IV. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its interim
determination of reregistration eligibility of terbufos, and lists the submitted studies that the
Agency found acceptable.
Although the Agency has not yet considered cumulative risks for the organophosphates,
the Agency is issuing this interim assessment now in order to identify risk reduction measures
that are necessary to support the continued use of terbufos. Based on its current evaluation of
terbufos alone, the Agency has determined that terbufos products, unless labeled and used as
specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a
registrant fail to implement any of the risk mitigation measures identified in this document, the
Agency may take regulatory action to address the risk concerns from use of terbufos.
At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. For terbufos, if all changes outlined in this document are incorporated
into the labels, then all current risks will be adequately managed. But, because this is an interim
RED, the Agency may take further actions, if warranted, to finalize the reregistration eligibility
decision for terbufos 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 mitigation measures,
the Agency is addressing the risks from the organophosphates in as timely a manner as possible.
Because the Agency has not yet considered cumulative risks for the organophosphates,
this reregistration eligibility decision does not fully satisfy the reassessment of the existing
terbufos food residue tolerances as called for by the Food Quality Protection Act (FQPA). When
the Agency has considered cumulative risks, terbufos tolerances will be reassessed in that light.
At that time, the Agency will reassess terbufos along with the other organophosphate pesticides
to complete the FQPA requirements and make a final reregistration determination. By
publishing this interim decision on reregistration eligibility and requesting mitigation now for
the individual chemical terbufos, 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.
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B. Summary of Phase 5 Comments and Responses
When making its interim reregi strati on decision, the Agency took into account all
comments received during Phase 5 of the OP Pilot Process. These comments in their entirety are
available in the docket. The Agency received comments and a risk mitigation proposal from the
registrant, BASF Corporation. The International Banana Association also sent comments on the
risk assessment and USDA commented on ecological risks of terbufos. The Agency also
received 113 comments from various agri-business companies and associations, commodity
companies, farm bureaus, universities, extension, and state agencies, as well as private citizens,
supporting the use of terbufos. Comments opposing the use of terbufos were received from the
Defenders of Wildlife and a private citizen. The Agency also received six comments on fish kill
incidents attributed to terbufos.
BASF Corporation submitted various comments pertaining to the Occupational and
Residential Revised Risk Assessment. Some of the comments are included below and a
complete response to the comments can be found in the public docket.
Comment
BASF found acceptable MOE's in their worker exposure studies with Counter 20C. This
differs from the Agency's assessment.
Response
The Agency does not concur with BASF's findings and states that if is not clear from the
registrants letter what input values were used to calculate the risk values.
Comment
BASF objected to the Agency's use of surrogate Pesticide Handlers Exposure Database
(PHED) data instead of available high quality product specific exposure data.
Response
The Agency does not concur with this comment. The Agency did use chemical specific
data from studies completed by American Cyanamid where appropriate and used PHED data in
cases where there was a lack of chemical-specific data to calculate risks.
Comment
BASF objects to the Agency's failure to use the enclosed cab tractors with open windows
scenario as an appropriate surrogate for open cab tractors.
Response
Review of the data shows that dermal exposure in the closed cab with open windows
scenario is two orders of magnitude less than PHED exposures with open cabs. Therefore, the
Agency feels closed cab tractors with open windows is more analogous to closed cabs than open
cab tractors. This data was used to assess worker risk for enclosed cab scenarios.
Comment
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BASF states that the EPA used 180 acres per day for corn in the chlorethoxyfos
assessment, a chemical with the same use pattern as terbufos. In addition, 180 acres is an
appropriate maximum estimate given that it is likely that the exposure is shared by two people an
average of 20% of the time.
Response
The Agency has used the acreage estimates from the corn cluster analysis for several
years and cannot substantiate why a different value was used for chlorethoxyfos. However, 180
acres was included in the Occupational and Residential Exposure chapter to allow for a more
informed risk management decision.
The International Banana Association (IBA) also sent a comment pertaining to the
Agency's use assumptions for terbufos in bananas. Some of the comments are included below
and a complete response to the comments can be found in the public docket.
Comment
The IBA calculated that 10.9% of a banana crop is treated with terbufos whereas the
Agency calculated the figure to be 26%.
Response
The Agency has reviewed the IBA proposal and concluded that this is not a valid
approach for assessing percent crop treated. The dietary risk from food was not a concern for
terbufos even with the 26% figure.
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 is for this individual organophosphate, and does not
attempt to fully reassess these tolerances as required under FQPA. FQPA requires the Agency to
evaluate food tolerances on the basis of cumulative risk from substances sharing a common
mechanism of toxicity, such as the toxicity expressed by the organophosphates through a
common biochemical interaction with the cholinesterase enzyme. The Agency will evaluate the
cumulative risk posed by the entire class of organophosphates once the methodology is
developed and the policy concerning cumulative assessments is resolved.
EPA has determined that risk from exposure to terbufos is within its own "risk cup." In
other words, if terbufos did not share a common mechanism of toxicity with other chemicals,
EPA would be able to conclude today that the tolerances for terbufos meet the FQPA safety
standards. In reaching this determination EPA has considered the available information on the
special sensitivity of infants and children, as well as the chronic and acute food exposure. An
aggregate assessment was conducted for exposures through food, residential uses, and drinking
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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 terbufos "fit" within the individual risk cup. Therefore, with the exception of
corn, pop fodder, the terbufos tolerances remain in effect and unchanged until a full reassessment
of the cumulative risk from all organophosphates is considered. The tolerance for corn, pop,
fodder, has been revoked because it is no longer a significant food item.
b. Tolerance Summary
In the individual assessment, tolerances for residues of terbufos in/on plant commodities
[40 CFR §180.352] are presently expressed in terms of the combined residues of terbufos [(S>-
((1, l-dimethyl)thio)methyl) O, O-di ethyl phosphorodithioate] and its cholinesterase-inhibiting
metabolites [40 CFR §180.352(a)]. The Agency concludes that the tolerance expression should
be stated in terms of" ...terbufos... and its phosphorylated (cholinesterase-inhibiting) metabolites:
• phosphorothioic acid, ^-(t-butylthio)m ethyl O,. O-di ethyl ester;
• phosphorothioic acid, ^-(t-butylsulfmyl)m ethyl O,. O-di ethyl ester;
• phosphorothioic acid, S!-(t-butylsulfonyl)m ethyl O,. O-di ethyl ester;
phosphorodithioic acid, ^-(t-butylsulfmyl)m ethyl O,. O-di ethyl ester;
phosphorodithioic acid, ^-(t-butylsulfonyl)m ethyl O,. O-di ethyl ester;
The chemical name for terbufos specified in 40 CFR §180.352(a) is incorrect, and should be
revised to read as "phosphorodithioic acid, $>-(t-butylthio)methyl O, O-diethyl ester."
Tolerances Listed Under 40 CFR S180.352(aV
The tolerances listed in 40 CFR §180.352(a) are for residues of terbufos and its
cholinesterase-inhibiting metabolites. Please note that several of the commodity definitions will
need to corrected to conform with current definitions.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR §180.352(a) for: bananas, beets, sugar, roots; beets, sugar, tops; corn, field, fodder;
corn, field, forage; corn, pop, fodder; corn, pop, forage; corn, grain; corn, sweet, (K+CWHR);
corn, sweet, forage; corn, sweet, fodder; sorghum, fodder, sorghum, forage, and sorghum, grain.
Certain commodity definitions of the above tolerances are not in accordance with the current
definitions and therefore need to be updated.
An adequate method is available for data collection and enforcement of terbufos
tolerances in or on plant commodities. The GLC/flame ionization-detection method for
determining terbufos and its phosphorylated metabolites is described in PAM, Vol. II, as Method
I. The hazardous reagent benzene is specified in this method.
Method M-1754, a modification of Method I in PAM that substitutes acetone for benzene
and methylene chloride for chloroform, underwent a successful Residue Analytical Laboratory
method validation trial and was forwarded to FDA for revision of PAM, Vol II.
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Table 8a. Tolerance Summary for Terbufos.
Commodity
Current Tolerance,
ppm
Tolerance
Reassessment*, ppm
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §352
Bananas
Beets, sugar, roots
Beets, sugar tops
Corn, field, fodder
Corn, field, forage
Corn, pop, fodder
Corn, pop forage
Corn, grain
Corn, sweet (K=CWHR)
Corn, sweet, forage
Corn, sweet, fodder
Sorghum, fodder
Sorghum, forage
Sorghum, grain
0.025
0.05(N)
0.1
0.5
0.5
0.5
0.5
0.05(N)
0.05(N)
0.5
0.5
0.5
0.5
0.05
0.025
0.05
0.1
0.5
0.5
0.5
revoke
0.05
0.05
0.5
0.5
0.5
0.5
0.05
Banana
The negligible residue residue (N)
should be deleted.
beet, sugar, roots
beet, sugar, tops
corn, field, stover
NA
corn, pop, stover
NA
The tolerance for "Corn, grain"
should be replaced with separate
tolerances for corn, field, grain
and Corn, pop, grain. The
negligible residue residue (N)
should be deleted
corn, sweet, kernel plus cob with
husks removed
The negligible residue residue (N)
should be deleted
NA
corn, sweet, stover
sorghum, grain, stover
sorghum, grain, forage
sorghum, grain, grain
* The term "reassessed" here is not meant to imply that the tolerance has been reassessed as required by FQPA, since this tolerance may
be reassessed only upon completion of the cumulative risk assessment of all organophosphates, as required by this law. Rather, it
provides a tolerance level for this single chemical, if no cumulative assessment was required, that is supported by all of the submitted
residue data.
Codex Maximum Residue Limits (MRLs) for the sum of terbufos, its oxygen analog and
their sulfoxides and sulfones, expressed as terbufos, have been established for a number of plant
and animal commodities. The Codex definition is compatible with the recommended revision to
the U.S. Tolerance definition, which specifically names terbufos, its oxygen analog, and their
sulfoxides and sulfones.
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No questions of compatibility exist with respect to commodities where: (i) no Codex
MRLs have been established but U.S. Tolerances exist; and (ii) Codex MRLs have been
established but U.S. Tolerances do not exist. Tolerances in such commodities as maize (corn),
popcorn, and sweet corn cannot currently be harmonized with CODEX tolerances; although both
U.S. and Codex tolerances in these commodities are based on the limit of detection (LOD), the
LOD under the CODEX system is 0.01 ppm, while the LOD under the U.S. system is 0.05 ppm.
Table 8b. Codex MRLs and Applicable U.S. Tolerances.
Commodity
Codex definition
Fodder beet leaves or
tops
Maize
Maize forage
Popcorn
Straw and fodder (dry)
of cereal grains
Sugar beet
Sweet corn (corn-on-
the-cob)
Reassessed U.S.
definition
beet, sugar, tops
corn, field, grain
corn, field, forage
corn, pop, grain
corn, field, stover
corn, pop, stover
corn, sweet, stover
sorghum, grain, stover
beet, sugar, roots
corn, sweet, kernel plus
cob with husks removed
MRL (Step) (rag/kg)
1 (5/8)
0.01 (5/8)
1 (5/8)
0.01 (5/8)
1(5)
0.1 (5)
0.01 (5)
Reassessed U.S.
Tolerance (ppm)
0.1
0.05
0.5
0.05
0.5
0.5
0.5
1
0.05
0.05
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program
to determine whether certain substances (including all pesticide active and other ingredients)
"may have an effect in humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may designate." Following the
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was scientific bases for including, as part of the program,
the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA
also adopted EDSTAC's recommendation that the Program include evaluations of potential
effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
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When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, terbufos may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
3. Labels
A number of label amendments, in addition to the existing label requirements, are
necessary in order for terbufos products to be eligible for reregi strati on. The Agency has
determined that these measures, in addition to the existing label requirements, will adequately
reduce risks to handlers.
Provided the following risk management measures are incorporated in their entirety into
labels for terbufos-containing products, the Agency finds that all currently registered uses of
terbufos are eligible for interim reregi strati on, pending consideration of cumulative risks of the
organophosphates. The regulatory rationale for each of the risk management measures outlined
below is discussed immediately after this list of required risk management measures.
a. Agricultural Use Exposure Reduction Measures
For agricultural use, the following measures are required, in addition to the existing
labeling requirements to address drinking water, occupational handler and ecological risks of
concern. The registrant has agreed to these measures.
Amend the North Carolina SLN registration of Counter 20CR to require the use of a
closed loading system.
• Require that the Counter 15G label be amended to indicate that applications must be
made using enclosed cab tractors.
• Reduce the application rate on sorghum from 1.96 Ibs. a.i. per acre to 1.70 Ibs. a.i.
per acre.
Require a 500 ft. vegetative buffer between treated area and surface water on
neighboring land
Require a 500 ft. vegetative buffer between a standpipe drain outlet and surface
water on neighboring land.
• Require a 66 ft. setback between the treated area and entry points to surface water
bodies on non-highly erodible soils
• Require a 300 foot setback between the treated area and entry points to surface water
bodies on highly erodible soils.
Require a 66 ft. setback between treated area and standpipes on terraced fields as
well as 66 ft. vegetative buffer between the tile outlet and surface water bodies
Restrict loading, rinsing, and washing equipment within 300 ft. from surface water
bodies or within 50 ft. from wells unless conducted on an impervious surface.
• Remove the "over the top" application for European corn borer control on corn.
Require placing granules for banded applications on corn in a 7 inch band over the
row, in front of the press wheel, and incorporated into the top 1 inch of soil.
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To prevent the flow of rainfall down planted rows, the label text will be required to
read "To prevent channeling of surface water run-off, adjust the planter row-cleaners
appropriately to prevent rows lower in height than adjacent soil".
b. Homeowner Use Exposure Reduction Measures
There are no residential uses for terbufos.
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
terbufos. 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 below the Agency's level of concern - less than 100% of
the acute PAD is used. For the most exposed subgroups, non-nursing infants and infants (< 1
year), the percent acute PAD values are 86% and 82%, respectively, at the 99.9th percentile of
exposure from consumption of food alone. No mitigation measures are necessary at this time to
address acute dietary risk from food. Dietary risk from food consumption is estimated using
anticipated residues from field trial data rather than residues from monitoring data. Anticipated
residues are generally considered to be more conservative than monitoring data in terms of
residue levels that consumers are exposed to in their diet. They represent maximum allowed
treatment parameters and do not account for any reduction in pesticide residue levels that may
occur from the time the crop is harvested until it is consumed. Additionally, the exposures are
based largely on residue values from field trial data below the limit of detection (LOD), between
the LOD and limit of quantitation (LOQ), or at the LOQ for which the Agency assumed residues
to be one half of the LOD. It should be noted that the available PDF monitoring data, while not
appropriate for the purposes of quantitative risk assessment, showed no detections of terbufos or
terbufos sulfone residues in over 100 samples of sweet corn. This suggests that the acute dietary
assessment is based on conservative exposure values that likely overstate risk.
2) Chronic Dietary (Food)
Chronic dietary risk from food alone is well below the Agency's level of concern. For the
most exposed subgroups, infants, the percent chronic PAD values are 9% or less. No mitigation
measures are necessary at this time to address chronic dietary risk from food.
3) Drinking Water
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The acute and chronic dietary risks from drinking water exposure are above the Agency's
level of concern for most subpopulations. However, there are uncertainties which lead the
Agency to expect that exposure from drinking water is unlikely to be as high as the levels used in
the development of the risk assessment. Based on these uncertainties and the anticipated impacts
on water resources from implementing the risk reduction measures contained in this document,
the Agency believes that the risks from drinking water are not of concern.
The drinking water risk assessments are based on screening level models that are
conservative in their estimates of drinking water exposure. Actual exposure is expected to be
lower than the EEC's reported in the IRED. An example of the type of assumptions used in the
model that can contribute to conservative estimates involves rainfall levels. To determine what
rainfall level to use in the model, the Agency identifies a peak rainfall level for each of 36 years
of daily rainfall data. The model then assumes that rainfall will equal the 90th percentile of these
36 annual peak values when estimating concentrations, a conservative assumption. Also, the
percent cropped area (PCA) assumption for sugar beets and sorghum used in the model is 0.87,
the default assumption. This means the model assumes that 87% of a watershed is planted with
one of these crops and that 100% of this crop is treated with terbufos, which appears unlikely to
occur especially considering that the PCA calculated for a major crop like corn using data
submitted to the Agency is 0.46.
Further, although the available NAWQA monitoring data were deemed insufficient for the
purpose of quantitative risk assessment primarily due to the failure to include metabolites of
terbufos, these data yielded surface water concentrations that were lower than the results of the
model. These levels ranged from 0.013 ppb to 0.56 ppb as compared to the model estimate for
parent terbufos of 9.39 ppm.
To provide additional perspective, it should also be noted that the maximum ground water
and surface water EEC's result from modeling terbufos use on sorghum. According to sales
figures for 2000 provided by the registrant, sorghum accounts for approximately 1% of total
terbufos use. The acute EEC's for corn which accounts for 90% of terbufos use are significantly
lower at 4.8 ppb (ground water) and 8.44 (surface water).
In addition, as explained earlier, the DWLOC is calculated based on dietary risk from food
consumption that is estimated using conservative exposure estimates (i.e. anticipated residues
from field trials, etc.). Therefore, the Agency expects that the actual exposure from food is
lower, which would result in additional space in the risk cup for residues in drinking water.
The risk reduction measures contained in this IRED, including the limitations on sales of
terbufos, reducing the maximum application rate for sorghum, increasing the depth of
incorporation of granules into the soil, removal of "over-the-top" applications, and the use of
vegetative buffer strips between treated field and water bodies and other areas where water
contamination could occur, particularly the use of a 500 foot buffer between a treated area and
water resources on nearby lands which would include such things as reservoirs, are expected to
provide improved protection of water resources from terbufos contamination. This supports the
Agency's belief that drinking water risks will be reduced to a level at which the risk cup is not
exceeded.
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Finally, the Agency is requiring surface and ground water monitoring data to confirm the
Agency's conclusions on dietary risks from drinking water. The Agency notes that drinking
water monitoring studies are either planned or underway which will inform the Agency
regarding its conclusions on levels of terbufos and its metabolites in drinking water. One of
these studies is related to the Unregulated Contaminant Monitoring Rule under which the EPA is
considering whether or not to set a drinking water standard for terbufos under the Safe Drinking
Water Act. This study is monitoring the levels of chemicals, including terbufos, in over 300
drinking water plants across the United States. The other study is being sponsored by the
American Crop Protection Association which will also monitor drinking water for pesticide
residues. In order for these studies to be used the Agency will need to confirm that samples were
taken from areas of terbufos use and during the time period when terbufos is used. Further,
monitoring for the important degradates of terbufos, terbufos sulfoxide and terbufis sulfone, will
need to be addressed.
b. Occupational Risk Mitigation
1) Agricultural Uses
EPA has risk concerns for occupational exposure scenarios assessed for the Counter 15G
product, even when used in a manner consistent with the engineering control parameters from
the occupational study. This assumes both use of a closed mixing and loading system (currently
on labels) and enclosed cabs for application (not a current label requirement). Specifically,
handlers have risks of concern when loading Counter 15G at the 2x North Carolina SLN rate on
corn and loading for sugar beets and sorghum at the maximum labeled rate (1.97 Ibs ai/acre) and
maximum acreage treated per day assumption of 213 acres. In addition, there are risks of
concern when applying Counter 15G in open cabs (maximum PPE) using the maximum
rate/acreage on corn, the North Carolina SLN 2x rate on corn, the maximum rate/acreage on
sugar beets, and the maximum rate/acreage on sorghum. The Agency also has risk concerns for
the scenario for 15G where application is made without a enclosed cab.
For application of Counter 15G, applicator risks are of concern at maximum PPE with
MOEs ranging from 2.7-5.3. When an enclosed cab is used the MOEs range from 157-208 and
are not of concern.
For loading of Counter 15G at the 2x North Carolina SLN rate on corn, the MOE is 53, a
value below the target MOE of 100. This value is based on a maximum acreage treated/day of
213 acres. However, based on survey data from North Carolina, the Agency has determined the
typical acreage treated per day to be 150 acres. The analysis conducted using this acreage
assumption results in a MOE of 75. In addition, the Agency's benefits assessment determined
there are currently no effective alternatives to terbufos for controlling billbugs in North Carolina
fields with high organic matter soil. Therefore, considering that engineering controls are in place
for this activity and there are significant benefits associated with this use, the Agency concludes
that no additional exposure reduction is warranted.
The MOEs for loading Counter 15G on sugar beets at the maximum rate (1.97 Ibs ai/acre)
and acreage (213 acres) is also below the target MOE of 100. However, based on a survey the
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Agency determined the acreage treated per day to be 130 acres for sugar beets. The analysis
conducted using this acreage assumption results in an acceptable MOE of 114.
The MOEs for loading Counter 15G on sorghum at the maximum rate (1.97 Ibs ai/acre)
and acreage (213 acres) is below the target MOE of 100. The registrant has agreed to reduce the
maximum application rate to 1.7 Ibs ai/acre which would result in a MOE of 81. This does not
reach the target MOE of 100, however, it is believed that reducing the rate further would reduce
the chemical's efficacy against sorghum pests. The primary alternative to terbufos, aldicarb, is
expensive compared to terbufos and the Agency has determined that choosing this alternative
would reduce the growers net revenues by as much as 78% if used. In addition, other
alternatives are not as efficacious in controlling wireworms, a pest of sorghum. Therefore, based
on the benefits of terbufos use on sorghum, the Agency concludes that no additional exposure
reduction is warranted.
For the Counter 20CR product, the Agency has some risk concerns when the product is
handled in open bags. Specifically, the Agency is concerned about risks to agricultural workers
handling Counter CR in open bags under the Special Local Need (SLN) registration in North
Carolina and loading for sugar beets and sorghum. There are no risk concerns when Counter CR
is handled in closed systems (Lock-N-Load) and open or enclosed cabs.
The MOE for handling Counter 20CR in open bags under the Special Local Need (SLN)
registration, which permits terbufos use on corn at twice the labeled maximum application rate,
is 64. This risk concern can be mitigated if the SLN registration is amended to require the use of
closed loading systems. The North Carolina Department of Agriculture and Consumer Services,
the department responsible for managing state registrations, and the registrant have agreed to
amend the SLN registration to make this a requirement on the label.
The MOEs for loading Counter 20CR in open bags on sugar beets at the maximum rate
(1.97 Ibs ai/acre) and acreage (213 acres) are below the target MOE of 100. As with the Counter
15G product, a survey of acreage treated per day determined the maximum to be 130 acres for
sugar beets which results in an acceptable MOE of 140.
The MOEs for loading Counter 20 CR in open bags on sorghum at the maximum rate (1.97
Ibs ai/acre) and acreage (213 acres) are also below the target MOE of 100. BASF has agreed to
reduce the maximum rate to 1.7 Ibs ai/acre which gives a MOE of 98.
Table 11 describes the necessary PPE and engineering controls to mitigate worker risks.
Table 9. Agricultural Uses: Handler Risk Concerns and Mitigation
Scenario
Loading granular in lock-n-load
containers (15G and 20 CR
formulation)
PPE
long-sleeved shirt and long pants, shoes plus
socks chemical-resistant gloves and chemical-
resistant apron
Engineering
Controls
lock-n-load
container
42
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Loading granular in open bags (20
CR formulation)
Applying 15G granular formulation
Applying 20 CR granular formulation
coveralls over long-sleeved shirt and long pants,
chemical-resistant apron, chemical resistant
gloves, chemical resistant footwear plus socks,
and OV respirator
long-sleeved shirt and long pants, shoes plus
socks
coveralls over long-sleeved shirt and long pants,
chemical resistant gloves, chemical resistant
footwear plus socks
none
enclosed cab
none
2) Post-Application Risk
There is a low potential for occupational post-application exposure when pre-emergent
insecticides are used. Terbufos is applied to the soil directly and is soil incorporated well before
the crops are mature. The timing of the application of terbufos can greatly reduce the potential
for post-application exposure. Also, most agricultural operations mechanically plant corn early
in the season, which minimizes the potential for dermal contact. Minimal exposure during
harvesting or any other late season activities is expected since terbufos is primarily applied pre-
emergent. Therefore, the Agency does not require a post-application occupational exposure
assessment (HED Exposure Science Advisory Council Policy No. 008). The REI for crops
treated with terbufos is 48 hours and 72 hours in areas where average annual rainfall is less than
25 inches per years. Early entry PPE for crops treated with terbufos is: coveralls worn over
long-sleeve shirt and long pants, chemical-resistant gloves made of any waterproof material,
chemical-resistant footwear plus socks, and protective eyewear.
c. Homeowner Risk Mitigation
Terbufos is not registered for use in residential settings.
2. Environmental Risk Mitigation
The Agency has determined that these risks can be reduced to an acceptable level taking
into consideration the benefits by a reducing the total amount of terbufos that can be applied
through imposing an annual sales cap and buffers. The registrant has agreed to a phased
approach that will ultimately reduce sales of terbufos by more than 55% by 2008 based on 2000
sales figures. By reducing the amount of terbufos applied in this way the Agency expects that
risks to aquatic and terrestrial organisms will be reduced.
The buffers to be implemented are; 1) a 500 ft. vegetative buffer between treated area and
surface water on neighboring land, 2) a 500 ft. vegetative buffer between a standpipe drain outlet
and surface water on neighboring land, 3) a 300 ft. setback between the treated area and entry
points to surface water bodies on highly erodible soils and 66 ft. on non-highly erodible soils, 4)
a 66 ft. setback between treated area and standpipes on terraced fields as well as 66 ft. vegetative
buffer between the tile outlet and surface water bodies, and 5) restricting loading, rinsing, and
washing equipment within 300 ft. from surface water bodies or within 50 ft. from wells unless
43
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conducted on an impervious surface. All setbacks must be planted to a crop or seeded with grass
or other suitable cover. Erosion potential of soils can be determined by consulting with the
National Resource Conservation Service (NRCS).
In addition, the registrant has agreed to remove from its labels the "over the top"
application on corn for european corn borer control. Banded applications on corn will also
require placing granules in a 7 inch band over the row, in front of the press wheel, and
incorporated into the soil to a depth of 1 inch. To prevent the flow of rainfall down planted
rows, the label text will read "To prevent channeling of surface water run-off, adjust the planter
row-cleaners appropriately to prevent rows lower in height than adjacent soil".
The Agency believes that the buffers and other changes in application methods described
above will reduce the likelihood that terbufos will contaminate surface water. In so doing, non-
target aquatic organisms, especially fish, would be less likely to be exposed to terbufos or its
metabolites.
The registrant has also committed to voluntarily remove use from counties where multiple,
verifiable fish kills occur in that county over a period of two or more years as the result of the
use of terbufos in accordance with the risk management measures set forth in this document.
The registrant will conduct product stewardship and educational efforts in counties where an
incident occurs to address the cause of the incident and seek to prevent a second incident which
would result in the discontinuation of use in that county.
3. Benefits Assessment
Both the preliminary and the revised human health and ecological risk assessments
identified risks of concern for occupational handlers and terrestrial and aquatic non-target
organisms. Since risks of concern in these areas are regulated under FIFRA's requirement that
the Agency consider the risks and benefits of pesticide use in making its regulatory decision, the
Agency has conducted a benefits assessment for use in determining the appropriate risk
management steps to be taken to address these risks. This assessment was aimed at quantifying,
to the extent possible, the benefits derived from the use of terbufos on corn primarily for control
of corn rootworm.
The benefits of terbufos on corn were estimated using a comparative product performance
assessment (BEAD Memo-Product Performance Assessment Methodology as Applied to
Terbufos Use on Field Corn, 12/15/2000). This assessment relied on data from numerous
product performance studies available in the open scientific literature. These data were analyzed
using statistical methods to determine the relative effects on corn yields of using terbufos and
other corn insecticides especially tefluthrin. The benefits assessment concluded that under most
conditions the alternative insecticides produced similar or greater yields than fields where
terbufos was used. Terbufos did show an advantage over the alternatives in controlling billbugs
in North Carolina and controlling corn rootworm in the Northeast. Terbufos also performed
more effectively on some secondary corn pests. However, there are uncertainties associated with
the assessment that were taken into consideration when developing the risk management
measures.
44
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The benefits assessment was reviewed by several independent external experts and the
United States Department of Agriculture. The registrant was also provided a courtesy copy. The
university researchers who provided an independent peer review of the assessment to the Agency
noted, in some instances, limitations or uncertainties that are associated with the assessment.
These include the use of yields versus root ratings in determining benefits, the use of small plot
studies to extrapolate to larger fields, and limitations of the statistical methods used to compare
and analyze the available data sets.
The Agency considered the results of the benefits assessment together with the
uncertainties present in the analysis when developing its risk reduction measures to address
occupational and ecological risks especially with regard to determining the appropriate level for
the sales limits considered to be a key aspect of risk management.
E. Other Labeling
In order to remain eligible for reregi strati on, other use and safety information need to be
placed on the labeling of all end-use products containing terbufos. For the specific labeling
statements, refer to Section V of this document
1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide
uses to affect any particular species, EPA puts basic toxicity and exposure data developed for
REDs into context for individual listed species and their locations by evaluating important
ecological parameters, pesticide use information, the geographic relationship between specific
pesticides uses and species locations, and biological requirements and behavioral aspects of the
particular species. This analysis will take into consideration any regulatory changes
recommended in this RED that are being implemented at that time. A determination that there is
a likelihood of potential impact to a listed species may result in limitations on use of the
pesticide, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice (54
FR 27984-28008, July 3, 1989) is currently being implemented on an interim basis As part of
the interim program, the Agency has developed County Specific Pamphlets that articulate many
of the specific measures outlined in the Biological Opinions issued to date. These Pamphlets are
available for voluntary use by pesticide applicators, on EPA's web site at www.EPA.gov/espp .
A final Endangered Species Protection Program, which may be altered from the interim program,
is scheduled to be proposed for public comment in the Federal Register before the end of 2001.
V. What Registrants Needs to Do
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In order to be eligible for reregi strati on, registrants need to implement the risk mitigation
measures outlined in Section IV and V, which include, among other things, submission of the
following:
A. For terbufos technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) Cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact Eric R. Olson at (703) 308-8067 with questions regarding generic
reregi strati on and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
46
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By US mail:
Document Processing Desk (DCI/SRRD)
Eric R. Olson
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Eric R.Olson
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient terbufos. registrants need to
submit the following items for each product.
(PDCI):
Within 90 days from the receipt of the product-specific data call-in
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregi strati on (EPA Form 8570-1).
Indicate on the form that it is an "application for reregi strati on";
(3) five copies of the draft label incorporating all label amendments outlined
in Table 12 of this document;
(4) a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share
offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please contact Karen Jones at (703) 308-8047 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By US mail:
Document Processing Desk (PDCI/PRB)
By express or courier service only:
Document Processing Desk(PDCI/PRB)
47
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Karen Jones Karen Jones
US EPA (7508C) Office of Pesticide Programs(7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of terbufos for the above eligible uses
has been reviewed and determined to be substantially complete. The following data gaps
remain:
• Drinking water monitoring data for both surface and groundwater sources for
terbufos and metabolite levels in corn, sorghum, and sugar beet growing regions.
This data is requested in order to confirm that the levels of these compounds are
lower than predicted in the Agency's water models (OPPTS 167-1-SS).
• Neurotoxic esterase (NTE) data on the hen to support the hen delayed neurotoxicity
study. (OPPTS 870.6100)
Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FIFRA (August 6, 1999 64FR 42945-42947, August 18
1999 64FR 44922-44923). 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. The
MUP labeling should bear the labeling contained in Table 10 at the end of this section.
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.
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A product-specific data call-in, outlining specific data requirements, accompanies this interim
RED.
2. Labeling Requirements for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in Table 10 at the end of
this section.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Interim Reregi strati on Eligibility Decision
document. Persons other than the registrant may generally distribute or sell such products for 50
months from the date of the issuance of this interim RED. However, existing stocks time frames
will be established case-by-case, depending on the number of products involved, the number of
label changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrant may distribute and sell terbufos products
bearing old labels/labeling for 26 months from the date of issuance of this interim RED. Persons
other than the registrant may distribute or sell such products for 50 months from the date of the
issuance of this interim RED. Registrants and persons other than the registrant remain obligated
to meet pre-existing Agency imposed label changes and existing stocks requirements applicable
to products they sell or distribute.
49
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D. Required Labeling Changes Summary Table
Table 10: Summary of Required Labeling Changes for Terbufos
Description
Required Labeling
Placement on Label
Manufacturing Use Products
Formulation
Instructions required on
allMUP's
"Only for formulation into an insecticide for use on corn, sugar beets, and grain
sorghum."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user group
"This product may be used to formulate products for specific use(s) not listed on the
MUP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on
the MUP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
"Environmental Hazards"
"This chemical is highly toxic to aquatic organisms (fish and invertebrates) and
wildlife. Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance contact your state Water Board or Regional
Office of the EPA"
Directions for Use
50
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Description
Required Labeling
Placement on Label
End Use Products Intended for Occupational Use (WPS)
Restricted Use Pesticide
"RESTRICTED USE PESTICIDE"
"Due to Acute Oral and Dermal Toxicity and Risks to Wildlife and Aquatic
Organisms."
"For retail sale to, and use only by Certified Applicators or persons under the direct
supervision of a Certified Applicator, and only for those uses covered by the Certified
Applicator's certification."
Top of front panel
Handler PPE
requirements (all
formulations)
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain terbufos the product label
must be revised to adopt the handler personal protective equipment (PPE)/engineering
control requirements set forth in this section. Any conflicting PPE requirements on the
current label must be removed.
For multiple-active-ingredient end-use products that contain terbufos, the handler
PPE/engineering control requirements set forth in this section must be compared with
the requirements on the current label, and the more protective language must be
retained. For guidance on which requirements are considered to be more protective, see
PR Notice 93-7.
PPE that is established on the basis of Acute Toxicity testing with the end-use products
must be compared with the active ingredient PPE specified below in this document.
The more protective PPE must be placed in the product labeling. For example, the
Handler PPE in this RED does not require protective eyewear which may be required
by the Acute Toxicity testing for the end-use product. For guidance on which PPE is
considered more protective, see PR Notice 93-7.
Precautionary
Statements Under PPE
Requirements
51
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Description
Required Labeling
Placement on Label
PPE Requirements
Established by the RED
for the polymer based
Granular Formulations
(20 CR) not marketed
in a closed loading
system (Lock 'n Load),
or any other system that
meets the specifications
of the WPS.
Note: SLN products are
not eligible for
reregi strati on if they are
not marketed in a
closed loading system.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Loaders applicators and other handlers must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical resistant gloves,
- chemical resistant footwear plus socks."
"In addition to the above, loaders and persons cleaning equipment must wear:
- chemical resistant apron
- a non-powered air purifying cartridge respirator equipped with an organic vapor (OV)
removing cartridge or canister plus an N-, R- or P- series filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" designation must be dropped.
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
52
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Description
Required Labeling
Placement on Label
PPE Requirements
Established by the RED
for the polymer based
Granular Formulations
(20 CR) marketed in a
closed loading system
(Lock 'n Load) or any
other system that meets
the specifications of the
WPS.
Note: SLN products are
only eligible for
reregi strati on if they are
marketed in a closed
loading system.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Loaders must wear:
- long-sleeved shirt and long pants,
- shoes plus socks
- chemical resistant gloves
- chemical resistant apron"
"See engineering controls for additional requirements"
"Applicators and other handlers must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical resistant gloves,
- chemical resistant footwear plus socks."
"In addition to the above, persons cleaning equipment must use a non-powered air
purifying cartridge respirator equipped with an organic vapor (OV) removing cartridge
or canister plus an N-, R- or P- series filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" designation must be dropped.
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
53
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Description
Required Labeling
Placement on Label
PPE Requirements
Established by the RED
for the clay based
Granular Formulations
(15 G) marketed in a
closed loading system
(Lock 'n Load) or any
other system that meet
the specifications of the
WPS
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Loaders and applicators must wear:
- long-sleeved shirt and long pants,
- shoes plus socks."
"In addition to the above, loaders must wear:
- chemical resistant gloves
- chemical resistant apron."
"See engineering controls for additional requirements."
"Handlers engaged in those activities for which use of an engineering control is not
possible, such as cleaning up a spill or cleaning or repairing contaminated equipment,
must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical resistant gloves,
- chemical resistant footwear plus socks,
- a non-powered air purifying cartridge respirator equipped with an organic vapor (OV)
removing cartridge or canister plus an N-, R- or P- series filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" designation must be dropped.
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
54
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Description
Required Labeling
Placement on Label
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables exist, use detergent and hot water. Keep and wash PPE
separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
immediately
following the PPE
requirements
Engineering controls for
the polymer based
Granular Formulation
(20 CR) marketed in a
closed loading system
(Lock 'n Load) or any
other closed system that
meets the specifications
of the WPS
"Engineering Controls"
"This product is formulated into a Lock 'N Load system that meets the definition of a
closed loading system in the Worker Protection Standard for Agricultural Pesticides [40
CFR 170.240(d)(4)]. In addition to wearing the required PPE specified above, loaders
must be provided and must have immediately available for use in an emergency, such as
a broken package, spill, or equipment breakdown: coveralls, chemical resistant
footwear plus socks, a non-powered air purifying cartridge respirator equipped with an
organic vapor (OV) removing cartridge or canister plus an N-, R- or P- series filter."
"When handlers use enclosed cabs, in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6),
the handler PPE requirements may be reduced or modified as specified in the WPS."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" designation must be dropped.
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
immediately
following the User
Safety Requirements
55
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Description
Required Labeling
Placement on Label
Engineering controls for
the polymer based
Granular Formulation
(20 CR) not marketed
in a closed loading
system
(Lock 'n Load) or any
other closed system that
meets the specifications
of the WPS
"When handlers use enclosed cabs, in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6),
the handler PPE requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
(Immediately
following PPE and
User Safety
Requirements.)
56
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Description
Required Labeling
Placement on Label
Engineering Controls
for the clay based
Granular Formulations
(15 G) marketed in a
closed loading system
(Lock 'n Load), that
meets the specifications
of the WPS
"Engineering Controls"
"This product is formulated into a Lock 'N Load system that meets the definition of a
closed loading system in the Worker Protection Standard for Agricultural Pesticides [40
CFR 170.240(d)(4)]. In addition to wearing the required PPE specified above, loaders
must be provided and must have immediately available for use in an emergency, such as
a broken package, spill, or equipment breakdown: coveralls, chemical resistant
footwear plus socks, a non-powered air purifying cartridge respirator equipped with an
organic vapor (OV) removing cartridge or canister plus an N-, R- or P- series filter."
"Applicators using motorized ground equipment must use an enclosed cab that meets
the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR
170.240(d)(5)] for dermal protection. In addition, such applicators must:
— wear the personal protective equipment required above for applicators;
— be provided and must have immediately available for use in an emergency
when they must exit the cab in the treated area: coveralls, chemical-resistant
gloves, chemical-resistant footwear, and a non-powered air purifying cartridge
respirator equipped with an organic vapor (OV) removing cartridge or canister
plus an N-, R- or P- series filter;
— take off any PPE that was worn in the treated area before reentering the cab,
and
— store all such PPE in a chemical-resistant container, such as a plastic bag, to
prevent contamination of the inside of the cab."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
(Immediately
following PPE and
User Safety
Requirements.)
57
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Description
Required Labeling
Placement on Label
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or
using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of
gloves before removing*. As soon as possible, wash thoroughly and change into clean
clothing."
Precautionary
Statements under:
Hazards to Humans
and Domestic
Animals immediately
following Engineering
Controls
(Must be placed in a
box.)
Environmental Hazards
"Environmental Hazards"
"This pesticide is highly toxic to fish and wildlife and has been known to cause fish
kills. Runoff may be hazardous to aquatic organisms in neighboring areas. Do not
apply directly to water or to areas where surface water is present or to intertidal areas
below the mean high-water mark. Keep out of lakes, ponds, and streams. Do not
contaminate water when disposing of equipment wastewater or rinsate. See Directions
for Use for required buffer zones or setbacks. Birds and mammals may be killed if
granules are not properly covered with soil in all areas of the treated field and in
loading areas. Cover, incorporate or clean up product that is spilled during loading or
that is visible on the soil surface in turn areas.
Do not apply in wet soil conditions that may prevent the equipment from covering
pesticide granules. Do not apply in frequently flooded areas.
Under certain field and weather conditions, terbufos and its degradates have a potential
for runoff into surface water for several weeks post-application."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
58
-------
Description
Required Labeling
Placement on Label
Restricted-Entry
Interval
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of 48 hours. The REI is 72 hours in areas where average rainfall is less
than 25 inches per year."
Directions for Use,
Agricultural Use
Requirements Box
Early Re-entry Personal
Protective Equipment
established by the RED.
"PPE required for early entry to treated areas that is permitted under the Worker
Protection Standard and that involves contact with anything that has been treated, such
as plants, soil, or water, is:
- coveralls worn over long-sleeve shirt and long pants,
- chemical-resistant gloves made of any waterproof material,
- chemical-resistant footwear plus socks, and
- protective eyewear"
Notification Statement
"Notify workers of the application by warning them orally and by posting warning
signs at entrances to treated areas."
Directions for Use,
Agricultural Use
Requirements Box
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may be in the area during application.
For any requirements specific to your State or tribe, consult the agency responsible for
pesticide regulation."
Place in the Direction
for Use directly above
the Agricultural Use
Box.
59
-------
Description
Required Labeling
Placement on Label
Other Application
Restrictions
Labels must be revised to reflect the reduced the application rate on sorghum from 1.96
Ibs. a.i. per acre to 1.70 Ibs. a.i. per acre.
Labels must be revise to reflect the following loader and applicator requirements to
minimize the potential for run-off to surface water:
"- maintain a 500 ft. vegetative buffer between treated area and surface water on
neighboring land,
- maintain a 500 ft. vegetative buffer between a standpipe drain outlet and surface water
on neighboring land,
- maintain a 66 ft. setback between the treated area and entry points to surface water
bodies on non-highly erodible soils,
- maintain a 300 ft. setback between the treated area and entry points to surface water
bodies on highly erodible soils,
- maintain a 66 ft. setback between treated area and standpipes on terraced fields as well
as 66 ft. vegetative buffer between the tile outlet and surface water bodies.
- No loading, rinsing, and washing equipment within 300 ft. from surface water bodies
or within 50 ft. from wells unless conducted on an impervious surface.
- all setbacks must be planted to a crop or seeded with grass or other suitable cover and
all vegetative buffers must be seeded with grass or other suitable cover,
"place granules in a 7 inch band over the row, in front of the press wheel, and
incorporate into the top 1 inch of soil for banded applications on corn,
'no over the top applications for European corn borer control,
'to prevent channeling of surface water run-off adjust the planter row-cleaners
appropriately to prevent rows lower in height than adjacent soil."
Place in the Direction
for Use Under
Application
Restrictions
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.
Instructions in the Labeling Required section not in quotes represents actions that the registrant must take to amend their labels or
product registrations.
60
-------
VI. Related Documents and How to Access Them
This interim Reregi strati on 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
August 7, 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 September 1, 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."
61
-------
VI. APPENDICES
62
-------
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
Site
Application Type
Application
Timing
Application
Equipment
Formulation
Maximum
Single
Application
Rate, ai
Maximum
Number of
Applications
Per Season
Maximum
Seasonal
Rate, ai
Minimum
Spray
Interval
(days)
Preharvest
Interval,
(days)
Reentry
Interval
(days)
Use Directions and Limitations
Food/Feed Crop Uses
Corn, field, pop, sweet
63
-------
Site
Application Type
Application
Timing
Application
Equipment
Banded, In
furrow
At plant
Ground
Formulation
15% granular
20% granular
Maximum
Single
Application
Rate, ai
1.3 Ib/A
Maximum
Number of
Applications
Per Season
1
Maximum
Seasonal
Rate, ai
1.3 Ib/A
Minimum
Spray
Interval
(days)
NA1
Preharvest
Interval,
(days)
NA
Reentry
Interval
(days)
2 days
Use Directions and Limitations
Buffers to be implemented are; 1) a 500 ft. vegetative buffer
between treated area and surface water on neighboring land, 2) a 500
ft. vegetative buffer between a standpipe drain outlet and surface
water on neighboring land, 3) a 66 ft. setback between the treated
area and entry points to surface water bodies on non-highly erodible
soils and 300 ft. on highly erodible soils, 4) a 66 ft. setback between
treated area and standpipes on terraced fields as well as 66 ft.
vegetative buffer between the tile outlet and surface water bodies, 5)
restricting loading, rinsing, and washing equipment within 300 ft.
from surface water bodies or within 50 ft. from wells unless
conducted on an impervious surface, 6) remove the "over the top"
application for European corn borer control, 7) require placing
granules for banded applications on com in a 7 inch band over the
row, in front of the press wheel, and incorporate into the top 1 inch
of soil, and 8) the label text will be required to read "To prevent
channeling of surface water run-off, adjust the planter row-cleaners
appropriately to prevent rows lower in height than adjacent soil".
All setbacks must be planted to a crop or seeded with grass or other
suitable cover.
Require that the Counter 1 5G label be amended to indicate that
applications must be made using enclosed cab tractors.
Amend the North Carolina SLN registration of Counter 20CR to
require the use of a closed loading system.
Sorghum, grain
64
-------
Site
Application Type
Application
Timing
Application
Equipment
Banded, Knifed
In
At bedding, at
plant
Ground
Formulation
15% granular
20% granular
Maximum
Single
Application
Rate, ai
1.7 Ib/A
Maximum
Number of
Applications
Per Season
1
Maximum
Seasonal
Rate, ai
1.71b/A
Minimum
Spray
Interval
(days)
NA
Preharvest
Interval,
(days)
NA
Reentry
Interval
(days)
2 days
Use Directions and Limitations
Buffers to be implemented are; 1) a 500 ft. vegetative buffer
between treated area and surface water on neighboring land, 2) a 500
ft. vegetative buffer between a standpipe drain outlet and surface
water on neighboring land, 3) a 66 ft. setback between the treated
area and entry points to surface water bodies on non-highly erodible
soils and 300 ft. on highly erodible soils, 4) a 66 ft. setback between
treated area and standpipes on terraced fields as well as 66 ft.
vegetative buffer between the tile outlet and surface water bodies, 5)
restricting loading, rinsing, and washing equipment within 300 ft.
from surface water bodies or within 50 ft. from wells unless
conducted on an impervious surface, 6) the label text will be
required to read "To prevent channeling of surface water run-off,
adjust the planter row-cleaners appropriately to prevent rows lower
in height than adjacent soil". All setbacks must be planted to a crop
or seeded with grass or other suitable cover.
Require that the Counter 1 5G label be amended to indicate that
applications must be made using enclosed cab tractors.
Sugar beets
65
-------
Site
Application Type
Application
Timing
Application
Equipment
Banded,
Modified In
furrow, Knifed
In
At plant
Ground
Formulation
15% granular
20% granular
Maximum
Single
Application
Rate, ai
1.97 Ib/A
Maximum
Number of
Applications
Per Season
1
Maximum
Seasonal
Rate, ai
1.971b/A
Minimum
Spray
Interval
(days)
NA
Preharvest
Interval,
(days)
NA
Reentry
Interval
(days)
2 days
Use Directions and Limitations
Buffers to be implemented are; 1) a 500 ft. vegetative buffer
between treated area and surface water on neighboring land, 2) a 500
ft. vegetative buffer between a standpipe drain outlet and surface
water on neighboring land, 3) a 66 ft. setback between the treated
area and entry points to surface water bodies on non-highly erodible
soils and 300 ft. on highly erodible soils, 4) a 66 ft. setback between
treated area and standpipes on terraced fields as well as 66 ft.
vegetative buffer between the tile outlet and surface water bodies, 5)
restricting loading, rinsing, and washing equipment within 300 ft.
from surface water bodies or within 50 ft. from wells unless
conducted on an impervious surface, 6) the label text will be
required to read "To prevent channeling of surface water run-off,
adjust the planter row-cleaners appropriately to prevent rows lower
in height than adjacent soil". All setbacks must be planted to a crop
or seeded with grass or other suitable cover.
Require that the Counter 1 5G label be amended to indicate that
applications must be made using enclosed cab tractors.
Non-Food/Non-Feed Crop Uses
Corn, field grown for seed
66
-------
Site
Application Type
Application
Timing
Application
Equipment
Banded, In
furrow
At plant
Ground
Formulation
15% granular
20% granular
Maximum
Single
Application
Rate, ai
1.3 Ib/A
Maximum
Number of
Applications
Per Season
1
Maximum
Seasonal
Rate, ai
1.3 Ib/A
Minimum
Spray
Interval
(days)
NA
Preharvest
Interval,
(days)
NA
Reentry
Interval
(days)
2 days
Use Directions and Limitations
Buffers to be implemented are; 1) a 500 ft. vegetative buffer
between treated area and surface water on neighboring land, 2) a 500
ft. vegetative buffer between a standpipe drain outlet and surface
water on neighboring land, 3) a 66 ft. setback between the treated
area and entry points to surface water bodies on non-highly erodible
soils and 300 ft. on highly erodible soils, 4) a 66 ft. setback between
treated area and standpipes on terraced fields as well as 66 ft.
vegetative buffer between the tile outlet and surface water bodies, 5)
restricting loading, rinsing, and washing equipment within 300 ft.
from surface water bodies or within 50 ft. from wells unless
conducted on an impervious surface, 6) remove the "over the top"
application for European corn borer control, 7) require placing
granules for banded applications on corn in a 7 inch band over the
row, in front of the press wheel, and incorporate into the top 1 inch
of soil, and 8) the label text will be required to read "To prevent
channeling of surface water run-off, adjust the planter row-cleaners
appropriately to prevent rows lower in height than adjacent soil".
All setbacks must be planted to a crop or seeded with grass or other
suitable cover.
Require that the Counter 1 5G label be amended to indicate that
applications must be made using enclosed cab tractors.
Amend the North Carolina SLN registration of Counter 20CR to
require the use of a closed loading system.
1 NA: Not applicable
67
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE
REREGISTRATION DECISION
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregi strati on for active ingredients within the case terbufos
covered by this RED. It contains generic data requirements that apply terbufos 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
68
-------
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.
69
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
PRODUCT CHEMISTRY
New Old
Guideline Guideline
Number Number
830.1550 61-1
830.1600 61-2A
830.1670 61-2B
830.1700 62-1
830.1750 62-2
830.1800 62-3
830.6302 63-2
830.6303 63-3
830.6304 63-4
830.7050 None
830.7200 63-5
Product Identity and
Composition
Start. Mat. & Mnfg.
Process
Formation of
Impurities
Preliminary Analysis
Certification of
limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
Melting Point
All 43147501, 41297901
All 41049501
All 41049501
All 41297902
All 43147502, 41297902
All 43147503, 41297902
All 41049502
All 41049502
All 41049502
All
All 41049502
70
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water
Partition Coefficient
pH
Stability
Oxidizing/Reducing
Action
F 1 ammab i 1 i ty
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion
USE PATTERN CITATION (S)
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41049502
41049502
41049502
41049502
41049502
41049502
41049502
41049502
41049502, 43147503
41049502
41049502
41049502
41049502
41049502
41049502
characteristics
ECOLOGICAL EFFECTS
71
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
850.2100 71-1
850.2200 71-2
850.2300 71-4
None
None
71-5B
850.1075 72-1
950.1010 72-2
None 72-3A
None
None
72-3B
72-3C
None 72-4A
850.1500 72-5
Avian Acute Oral
Toxicity Test
Avian Dietary Toxicity
Test
Avian Reproduction
Test
71-5A Simulated Field Study
Terrestrial Field
Study
Fish Acute Toxicity
Aquatic Invertebrate
Estuarine/Marine
Toxicity - Fish
Estuarine/Marine
Toxicity - Mollusk
Estuarine/Marine
Toxicity - Shrimp
Fish- Early Life Stage
Life Cycle Fish
FEOTER02
00035120, 00087717, 00160387
00097892, 00161574, 00191573
FEOTER01, 00085179, 00085183,
40985501, 40993501, 41475801,
41508801, 41849201
BAOTER01, 00085178, 00085180,
00087726
FEOTER04, FEOTER05, 00037483,
00085176, 00087718
FEOTER03, 00085176
41373602, 41373603
00162524, 42381501
00162523, 41297903
00162525, 40009301, 41475802
Reserved
72
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
None
72-6
850.1950 72-7A
TOXICOLOGY
870.1100 81.1
870.1200 81-2
870.1300 81-3
870.2400 81-4
870.2500 81-5
870.2600 81-6
870.6100 81-7
870.6200 81-8
870.3100 82-1
870.3200 82-2
870.3465 82-4
Aquatic Org.
Accumulation
Simulated Field-
Aquatic Organisms
Acute Oral-Rat
Acute Dermal-Rabbit
Acute Inhalation-Rat
Primary Eye Irritation
Primary Skin
Irritation
Dermal Sensitization
Delayed Neurotoxicity
Acute Neurotoxicity
Subchronic 90 Day Oral
Toxicity
21-Day Dermal -
Rabbit/Rat
Subchronic Inhalation
Toxicity
Waived, 41373603
Waived
00029863
258710
41538101
0044957
00044957
44942302
00037472
44672003
44842302
00085169, 40374701, 44450600,
44450601, 44520501, 44690501
00258710
73
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
870.4100 83-1
870.3700 83-3A
870.3700 83-3B
870.3800 83-4
870.4300 83-5
Chronic Toxicity
D eve1opmenta1
Toxicity-Rat
Developmental Toxicity
- Rabbit
2-Generation
Reproduction - Rat
Combined Chronic
Toxicity/
Carcinogenicity
General Metabolism
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100 132-1A
870.7485 85-1
Foliar Residue
Dissipation
Dermal Passive
Dosimetry Exposure
Inhalation Passive
Dosimetry Exposure
ENVIRONMENTAL FATE
875.2400 133-3
875.2500 133-4
835.2120 161-1
Hydrolysis of Parent
and Degradates
00263678, 40374701
00147533
00147533, 40886301, 40966401
00085172, 43649402
00049236, 40089602, 40089603
42348801
Waived
44862501
74
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
835.2240 161-2
835.2410 161-3
835.2370 161-4
835.4100 162-1
835.4200 162-2
835.4300 162-4
835.1240 163-1
835-1410 163-2
835-8100 163-3
835.6100 164-1
835-6500 164-5
Photodegradation -
Water
Photodegradation -
Soil
Photodegradation - Air
Aerobic Soil
Metabolism
Anaerobic Soil
Metabolism
Aerobic Aquatic
Metabolism
Leaching/Adsorption/De
sorption
Volatility-Lab
Volatility-Soil
Terrestrial Field
Dissipation
Long-Term Soil
Dissipation
860-1900 165-2 Field Rotational Crop
00161567, 41181101
Waived
Waived
00156853
41749801
44672004, 44862502
41373604
Waived
Reserved
41883100, 44381201
Reserved
40940701
75
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
None
165-4 Bioaccumulation in
Fish
RESIDUE CHEMISTRY
860-1200 171-3 Directions for Use
860.1300 171-4B
Nature of Residue -
Livestock
41373603, 41373605
41475803, 41475804, 42576900
860.1340 171-4C Residue Analytical
Method - Plants
860.1340 171-4D Residue Analytical
Method - Animals
860.1380 171-4E Storage Stability
860.1480 171-4J
860.1500 171-4K
860.1500 171-4K
860.1500 171-4K
Magnitude of Residues
- Meat/Milk/Poultry
/Egg
Crop Field Trials
(Sugar Beets)
Crop Field Trials
(Corn-Field)
Crop Field Trials
(Sorghum)
41475804
Reserved
40940701, 41373606, 43237800,
43649401, 44464601
Reserved
41569401, 442679
41955601
41569402, 42661801
76
-------
Data Supporting Guideline Requirements for the Reregistration of Terbufos
REQUIREMENT
USE PATTERN CITATION (S)
860.1520 171-4L
860.1520 171-4L
OTHER
None 82-3SS
None 163-A-
SS
870-6200 None
870,6200 None
870-6300 None
Processed Foods (Corn,
Field)
Processed Foods
(Sorghum, Grain)
Human Incident Data
Monitoring Studies-
Soil
Neurotox Screening
Battery-Acute
Neurotox Screening
Battery-Acute
Developmental Neurotox
41955601, 43237800
41569402, 43237800
77
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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:
3. Organophosphate Pesticides: Terbufos Availability of Revised Risk
Assessment (FR Notice)
4. Human Health Risk Assessment: Terbufos
5. Terbufos Toxicology Chapter for RED
6. Terbufos: Revised Acute and Chronic Dietary Exposure Analyses for the
HED Revised Risk Assessment
7. Terbufos: Revised Probabilistic (Monte Carlo) Dietary Exposure Analysis
and Supporting Documentation
8. Terbufos: Revised Probabilistic (Monte Carlo) Acute Dietary Exposure and
Risk
9. Terbufos: Comprehensive Report of the Toxicological Endpoints Selection
Report of the Hazard Identification Assessment Review Committee
(HIARC)
10. Terbufos: Report of the FQPA Safety Factor Committee
11. The Revised Occupational and Residential Exposure Aspects of the HED
Chapter of the RED for Terbufos
EFED Documents:
78
-------
12. Terbufos: Revised EFED RED Chapter Revision of Fate and Transport and
Water Resources
79
-------
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 Reregi strati on Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources including the published literature,
in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID" number. This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies
(see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also
to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
80
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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.
81
-------
BIBLIOGRAPHY
MRID
CITATION
00029863 Consultox Laboratories (1975) Acute Oral and Percutaneous Toxicity
Evaluations. (Unpublished study received Feb 3, 1976 under 2749-425;
submitted by Aceto Chemical Co., Inc., Flushing, N.Y.; CDL:241780-A)
00035120 Krize, J.W.; Terrell, Y. (1978) Report: Avian Dietary LC50 (5-Day Dietary
Exposure) of Enlist Technical (Terbufos Technical) EPA File Symbol 2749 UEL
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00037472 Smith, J.H.; Rosselet, C.; Cannelongo, B.; et al. (1972) A Neurotoxicity Study of
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00258710 See MRID Numbers 00144805 to 00144806
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88
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Terbufos registration standard. Transmittal of 1 study.
42576901 Cheng, T. (1992) Terbufos (CL92,100): Metabolic Fate of (carbon 14)-Labeled
CL 92,100 in Milk and Edible Tissues of the Lactating Goat: Lab Project
Number: HWI 6123-174: M92A100WI1. Unpublished study prepared by
Hazleton Wisconsin, Inc. 117 p.
93
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BIBLIOGRAPHY
MRID
CITATION
42661801 Kleiner, A. (1992) CL 92,100 (terbufos/15 G): Residues of Total CL
92,100-Related Compounds in Dual Purpose Sorghum (KI; TX, 1991): Lab
Project Number: C-3851. Unpublished study prepared by American Cyanamid
Co. 52 p.
43147501 Cortes, D.; Thomson, M. (1994) Product Identity and Discussion of Formation of
Impurities for COUNTER Technical: Addendum: Lab Project Number:
CHDV/VOL/29/REPORT/2. Unpublished study prepared by American
Cyanamid Co. 44 p.
43147502 Thomson, M.; Wilson, L. (1994) Preliminary Analysis, Certification of Limits,
and Analytical Methods for Enforcement for COUNTER Technical: (Addendum):
Lab Project Number: APBR/308: APBR/307. Unpublished study prepared by
American Cyanamid Co. 95 p.
43147503 Rahaman, R. (1994) Physical and Chemical Characteristics for COUNTER
Technical: Addendum: Lab Project Number: CHDV/VOL/29/REPORT/3.
Unpublished study prepared by American Cyanamid Co. 4 p.
43237800 American Cyanamid Co. (1994) Submission of residue data in support of
registration standard for terbufos. Transmittal of 2 studies.
43237801 Cheng, T.; Zulalian, J. (1994) Terbufos (CL 92,100): Metabolic Fate of
Carbon-14 CL 92,100 Derived Residues in Tissues and Milk of Lactating Goats:
Addendum: Lab Project Number: HWI/6123/174: 6123/174. Unpublished study
prepared by Hazelton Wisconsin, Inc. 64 p.
43237802 Higham, J.; Fisher, R. (1988) CL 92100 (terbufos/15G): Residues of Total CL
92,100-Related Compounds in Sweet Corn Following Banded and Post
Applications in New York, Wisconsin, and Florida: Lab Project Number: C/3093:
C/3096: C/3109. Unpublished study prepared by American Cyanamid Co. 28 p.
43649401 Wrubel, J. (1995) Summary of Previously Submitted Terbufos Data in Partial
Fulfillment of the Requirements for Residue Commodity Storage Stability Data.
Unpublished study prepared by American Cyanamid Co. lip.
94
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BIBLIOGRAPHY
MRID
CITATION
43649402 Schroeder, R. (1989) A Two-Generation (Two-Litters) Reproduction Study With
AC 92,100 to Rats: Lab Project Numbers: 86-3128: 971-87-132. Unpublished
study prepared by Bio/dynamics, Inc. 1806 p.
44267901 York, C. (1996) Terbufos (CL 92,100): Total CL 92,100-Related Residues in
Sugar Beets After Treatment with Counter 15G Systemic Insecticide Nematicide
Applied Postemergence: Lab Project Number: RES 95-039: RES 95-040: RES
95-045. Unpublished study prepared by American Cyanamid Co. 422 p.
(OPPTS 860.1500}.
44267902 Higham, J.; Picard, G. (1996) Terbufos (CL 92,100): Validation of Method
M-2457 for the Determination of Total CL 92,100-Related Residues in Sugar
Beet Tops and Roots: Lab Project Number: RES 95-118: ABC 42332:
CT94PT01. Unpublished study prepared by American Cyanamid Co. and ABC
Laboratories, Inc. 52 p. {OPPTS 860.1340}.
44381201 Khunachak, A. (1997) CL 92,100 (Counter Systemic Insecticide Nematicide):
Freezer Storage Stability of Residues of Terbufos (CL 92,100) and its Related
Compounds (CL 94,301 and CL 94,320) in Soil: (Final Report): Lab Project
Number: RES 96-073.01: CT95PT01: 0107. Unpublished study prepared by
American Cyanamid Co. and ABC Labs, Inc. 60 p. {OPPTS 840.1100}
44450600 American Cyanamid Co. (1997) Submission of Toxicology Data in Support of the
Reregi strati on for Terbufos. Transmittal of 1 Study.
44450601 Compton, D. (1997) A Preliminary Range-Finding Rat Dermal Toxicity Study
with AC 92100 CR: Lab Project Number: 97-2518: 971-97-125. Unpublished
study prepared by Huntingdon Life Sciences. 128 p. {OPPTS 870.3200}
44464601 Higham, J. (1997) CL 92100: Freezer Storage Stability of Residues of
Terbufos-Related Compounds (CL 94301, CL 94320, and CL 94221) in Sugar
Beet Tops and Roots: Lab Project Number: RES 97-017: CT94PT02: 0107.
Unpublished study prepared by ABC Laboratories, Inc. and American Cyanamid
Co. 52 p. {OPPTS 860.1380}
95
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BIBLIOGRAPHY
MRID
CITATION
44520501 Kelly, C. (1998) A Four-Week Rat Dermal Toxicity Study with AC 92100 15G:
Lab Project Number: 96-2487: 971-96-149. Unpublished study prepared by
Huntingdon Life Sciences. 547 p. (OPPTS 870.3200}
44629302 Khunachak, A.; Kleiner, A.; Gross, J. (1998) Crop Residue Studies: Total
Terbufos-Related Residues in Bananas After Treatment with Counter Systemic
Insecticide-Nematicide: Lab Project Number: C-2789: C-3136: RES97-062.
Unpublished study prepared by American Agricultural Services, Inc. and Centre
Analytical Laboratories, Inc. 385 p. {OPPTS 860.1340, 860.1500}
44629303 York, C.; Fletcher, P. (1998) Crop Residue Studies: Total Terbufos-Related
Residues in Corn Grain After Treatment with Counter Systemic
Insecticide-Nematicide Applied Post-Emergent or at Cultivation: Lab Project
Number: RES95-058: RES95-059: RES96-021. Unpublished study prepared by
Heartland Technologies, Inc. and ABC Laboratories, Inc. 430 p. {OPPTS
860.1500}
44672003 Mandella, R. (1998) An Acute Neurotoxicity Study with AC 92100 in the Rat Via
Oral Gavage Administration: Lab Project Number: 98-4525: 97-4517:
971-98-140. Unpublished study prepared by Huntingdon Life Sciences. 763 p.
{OPPTS 870.6200}
44672004 Kloppel, H. (1993) Degradation of (Carbon 14)-Terbufos in Water/Sediment
Systems: Lab Project Number: CYA-013/7-19. Unpublished study prepared by
Fraunhofer-Institut fuer Umweltchemie und Okotoxikologie. 57 p.
44690501 Compton, D. (1998) A Four-Week Rat Dermal Toxicity Study with AC 92100
CR: Lab Project Number: CY216: 96-2494: 97-2518. Unpublished study
prepared by Huntingdon Life Sciences. 253 p. {OPPTS 870.3200}
44793301 Higham, J.; Walls, C.; Sweeney, R. et al. (1999) Occupational Exposure and Risk
Assessment for Loaders and Applicators Handling Terbufos Products and
Supporting Worker Exposure Studies: Lab Project Number: CY-24: 9902:
EXA-99-004. Unpublished study prepared by ABC Laboratories, Inc. and
Novigen Sciences. 607 p. {OPPTS 875.1000, 875.1100, 875.1300}
96
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BIBLIOGRAPHY
MRID
CITATION
44834301 Barraj, L.; Kidwell, J. (1999) Sensitivity Analysis Considering the Acute Dietary
Exposure Estimates in the Terbufos Risk Assessment: Lab Project Number:
99-01. Unpublished study prepared by Novigen Sciences, Inc. 254 p.
44842302 Mandella, R. (1999) 13-Week Dietary Neurotoxicity Study with AC 92100 in the
Rat: Lab Project Number: 98-4521: 971-98-102. Unpublished study prepared by
Huntingdon Life Sciences. 734 p. (OPPTS 870.6200}
44862501 Martin, C.; Heim, D. (1999) (Carbon-14)-Terbufos (AC92100) and its
Sulfoxide(AC94301) and Sulfone(AC94320) Metabolites: Hydrolysis in Sterile
pH 5,7, and 9 Buffers: Lab Project Number: ENV97-017: ENV 97-017.01.
Unpublished study prepared by ABC Labs., Inc. 388 p. {OPPTS 835.2120}
44862502 Martin, C.; Xia, C. (1999) (Carbon-14)-Terbufos (AC92100) and its
Sulfoxide(AC94301) and Sulfone(AC94320) Metabolites: Degradation in Natural
Pond Water: Lab Project Number: ENV-97-018. Unpublished study prepared by
ABC Labs., Inc. 133 p. {OPPTS 835.2120, 835.4300}
97
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BIBLIOGRAPHY
CITATION
Studies Without MRID Numbers
Austin, 1981. Land Resources Regions and Major Land Resource Areas of the
United States. USDA Handbook 296, revised 1981. Washington, D.C. (Soil
Conservation Service)
Barrett, M.R., December 3, 1997. Memorandum from Joe Merenda to Larry
Dorsey of the Science Advisory Panel. U.S. EPA/OPP/EFED.
Blondell JM, Taub SR. 1999. Poisoning incidence per 1000 applications among
handlers of agricultural insecticides in California and acute dermal toxicity.
Pesticides, People and Nature 1:15-24.
DeLuca, T., Larson, J., Torma, L. and G. Algard. 1989. A Survey of
Groundwater Contamination by Pesticides in Montana, Montana Department of
Agriculture, Technical Report 89-1, August 1989.
Detroy, M. 1985. Iowa Ground-Water-Quality Monitoring Program, U.S.
Geological Survey, Open File Report 84-815, December 1985.
Detroy, M., Hunt, P., and M. Holub. 1988. Ground-Water-Quality Monitoring in
Iowa: Nitrate and Pesticides in Shallow Aquifers, U.S. Geological Survey, Water
Resources Investigations Report 88-4123.
Exner, M. and Roy Spalding. 1990. Occurrence of Pesticides and Nitrate in
Nebraska's Ground Water, University of Nebraska, Institute of Agriculture and
Natural Resources.
Felsot, A., L. Wei, and J. Wilson. 1982. Environmental chemodynamic studies
with terbufos (Counter™) insecticide in soil under laboratory and field conditions.
Journal of environmental science and health. Vol. B17(6), pp. 649-673.
Felsot, A., W.N. Bruce, andK.S. Steffey. 1987. Degradation of terbufos
(Counter™) soil insecticide in corn fields under conservation tillage practices.
Bulletin of Environmental Contamination and Toxicology Vol. 38:369-376.
98
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BIBLIOGRAPHY
CITATION
Hirsch, R.M. Alley, W.M., and Wilbur, W.B. 1988. Concepts of National Water
Quality Assessment Program. USGS Circular 1021.
Indiana Department of Environmental Management. 1988. Assessment of
Nonpoint Source Pollution of Ground Water in Indiana, July 1988.
Kelley, R.. 1985. Synthetic Organic Compound Sampling Survey of Public
Water Supplies, Iowa Department of Natural Resources, Des Moines, IA, April
1985.
Kelley, R. and Wnuk, M. 1986. Little Sioux River Synthetic Organic Compound
Municipal Well Sampling Survey, Iowa Department of Natural Resources, Des
Moines, IA, March 1986.
Kelley, R. 1986. 1986 Little Sioux River Pesticide Monitoring Report, Iowa
Department of Natural Resources, Des Moines, IA, March 1988.
Kelley, R. 1986. University of Iowa, Hygienic Laboratory, personal
communication.
Klaseus, T., Buzicky, G. and E. Schneider. 1988. Pesticides and Ground Water:
Surveys of Selected Minnesota Wells, Minnesota Department of Health and
Minnesota Department of Agriculture, February 1988.
Klaseus, T. and Hines, J. 1989. Pesticides and Ground Water: Surveys of
Selected Minnesota Wells, Minnesota Department of Health, August 1989.
Kleinbaum, D.G., L.L. Kupper, and H. Morgenstern. 1982. Epidemiological
Research. Van Nostrand Reinhold.
Knapton, R.W., and P. Mineau. 1995. Effects of granular formulations of
terbufos and fonofos applied to cornfields on mortality and reproductive success
in songbirds. Ecotoxicology 4:138-153.
Lane, L. 1987. Mississippi Pesticide Hazard Assessment Project: Annual
Progress Report No. 15, Mississippi State University, May 1987.
99
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BIBLIOGRAPHY
CITATION
Mayer, F.L. and Ellersieck, M.R. 1986. Manual of acute toxicity: interpretation
and data base for 4510 chemicals and 66 species of freshwater animals. USFWS
Resource publ. 160.
Mesko, T. and Carlson, G. 1988. Occurrence of Pesticides, Nitrates, Organic
Compounds, and Trace Elements in Ground Water and Streams, Southeastern
Missouri, 1986-87, U.S. Geological Survey Open-File Report 88-495.
Rhode Island Department of Environmental Management. 1990. Rhode Island
Private Well Survey Final Report.
Sievers, D. and Fulhage, C. 1991. Quality of Rural Well Water North Missouri
and Quality of Missouri's Agricultural Groundwater Region II Sampling,
University of Missouri, June 1991.
South Dakota Department of Environment and Natural Resources. 1993. 1992
Pesticide and Nitrogen Sampling Program and Five Year SumM., February 1993.
USEPA. 1992. Pesticides in Ground Water Database - A Compilation of
Monitoring Studies: 1971 - 1991. Office of Prevention, Pesticides, and Toxic
Substances. EPA 734-12-92-001. September 1992.
USEPA Office of Water. February 1996, Drinking Water Regulations and Health
Advisories, EPA 822-R-96-001
United States Environmental Protection Agency, Guidelines for Exposure
Assessment; Federal Register Volume 57, Number 104 (Friday May 29, 1992).
USEPA, Draft Standard Operating Procedures (SOPs) For Residential Exposure
Assessment (December 11, 1997).
USEPA, Series 875 - Occupational and Residential Exposure Test Guidelines,
Group B - Postapplication Exposure Monitoring Test Guidelines; Version 5.4;
(February 10, 1998).
USEPA, Pesticide Handlers Exposure Database, Version 1.1; (1993).
100
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BIBLIOGRAPHY
CITATION
USEPA, Exposure Factors Handbook, EPA Report 600/P-95/002Fa, August,
1997.
Terbufos: Revised Risk Assessment; (3/4/99) Chemical ID No. 105001, Case
0109, DP Barcode D253850, From William Hazel (OPP/HED/RRB-1) to Pamela
Noyes and Robert McNally (OPP/SRRD).
Various Correspondence From American Cyanamid to the EPA (letters dated
June 23, 1999; August 20, 1998; October 12, 1998; and January 15, 1999).
Authored by Mark Galley, Director U.S. Plant Regulatory Affairs or John
Wrubel, Product Registrations Manager, U.S. Plant Regulatory Affairs.
Occupational And Residential Exposure Assessment And Recommendations For
The Reregi strati on Eligibility Document For Terbufos; (May 18, 1995) Chemical
ID No. 105001, Case 0109, DP Barcode D192404, From Alan P. Nielsen
(OPP/HED/OREB) to Karen Whitby (OPP/HED/RCAB).
Current ORE Issues Related To Terbufos (Chem # 105001) RED Status; (March
4, 1998), DP Barcode D241134 and D243778 From Jeff Dawson
(OPP/HED/RRB-1) to William Hazel (OPP/HED/RRB-1).
Use and Usage Information; (7/15/99) sent by email by John Wrubel (Product
Review Manager, American Cyanamid) to Jeff Dawson U.S. EPA
(OPP/HED/RRB-1) with cc. to EPA CRM and U.S.D.A.
Quantitative Usage Analysis; (July, 1999) completed by Dhol Herzi
(EPA/OPP/BEAD).
Final Usage Analysis For Terbufos RED; (2/8/99) From Donald Atwood and
Kathy Davis (OPP/BEAD) to Pamela Noyes (OPP/SRRD).
Occupational Exposure and Risk Assessment For Loaders and Applicators
Handling Terbufos Products and Supporting Worker Exposure Studies; (3/26/99)
Authored by Joseph Higham, Richard Honeycutt, D. Larry Merricks, Rose A.
Sweeney, Cassi L. Walls, and Susan H Youngren; Completed by ABC
Laboratories of Columbia MO, HERAC of Greensboro NC, Agrisearch of
Frederick MD, Novigen Sciences of Washington DC, and American Cyanamid of
Princeton NJ.; Project ID #s include: Exhibit 1 of EPA MRID 447933-01,
101
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BIBLIOGRAPHY
CITATION
Terbufos 99-02, EXA 99-004, EXA 99-006, and RES 99-003, Sponsored by
American Cyanamid.
Exposure of Farmworkers To Terbufos (CL 92100) While Loading COUNTER
15G Systemic Insecticide-Nematicide With A Lock-N-Load Closed Handling
System And Applying COUNTER 15G To Corn At Planting Time; (3/26/99)
Authored by Joseph Higham; Completed by ABC Laboratories of Columbia MO,
Agrisearch of Frederick MD, and American Cyanamid of Princeton NJ.; Project
ID #s include: Exhibit 2 of EPA MRID 447933-01, Terbufos 99-02, EXA 99-004,
EXA 99-006, and RES 99-003, Sponsored by American Cyanamid.
Exposure of Farmworkers To Terbufos (CL 92100) While Loading COUNTER
CR Systemic Insecticide-Nematicide From A Bag And Applying COUNTER CR
To Corn At Planting Time; (3/26/99) Authored by Joseph Higham; Completed by
ABC Laboratories of Columbia MO, HERAC of Greensboro NC, and American
Cyanamid of Princeton NJ.; Project ID #s include: Exhibit 3 of EPA MRID
447933-01, Terbufos 99-02, EXA 99-004, EXA 99-006, and RES 99-003,
Sponsored by American Cyanamid.
CL92100 (terbufos): Validation of GC/FPD Determinative Methods M3153,
M3154, M3155, and M 3156 For The Determination of CL 92100 Residues In,
Respectively, Whole Body Dosimeters, Aerosol OT Handwash and Glove Wash
Solutions, Air Sampling Tubes and Face/Neck Wipes; (3/26/99) Authored by
Joseph Higham, Jill Cooper, and Rose Sweeney; Completed by ABC Laboratories
of Columbia MO, and American Cyanamid of Princeton NJ.; Project ID #s
include: Exhibit 4 of EPA MRID 447933-01, ABC Report 44703, and RES 99-
003, Sponsored by American Cyanamid.
Terbufos Updated Risk Assessment USDA Comments; (June 25, 1999)
Forwarded by Therese Murtaugh of USDA.
Terbufos (AC 92100) - Response To Registrant's Rebuttal Regarding Reference
Dose; Dust Generation/Characterization Studies; (July 5, 1996) Authored by Alan
C. Levy (OPP/HED/Tox-II) to William Hazel and Christina Swartz
(OPP/HED/RCAB). Provides cursory review of study entitled Counter CR and
Counter 15G, Dust Generation and Characterization by V Arendt (completed on
2/16/96, ID F-1356, submitted on 5/23/96).
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BIBLIOGRAPHY
CITATION
Exposure of Farmworkers To Terbufos (CL 92100) While Loading COUNTER
15G Systemic Insecticide-Nematicide With A Lock-N-Load Closed Handling
System And Applying COUNTER 15G To Corn At Planting Time; (3/26/99)
Authored by Joseph Higham; Completed by ABC Laboratories of Columbia MO,
Agrisearch of Frederick MD, and American Cyanamid of Princeton NJ.; Project
ID #s include: Exhibit 2 of EPA MRID 447933-01, Terbufos 99-02, EXA 99-004,
EXA 99-006, and RES 99-003, Sponsored by American Cyanamid.
Exposure of Farmworkers To Terbufos (CL 92100) While Loading COUNTER
CR Systemic Insecticide-Nematicide From A Bag And Applying COUNTER CR
To Corn At Planting Time; (3/26/99) Authored by Joseph Higham; Completed by
ABC Laboratories of Columbia MO, HERAC of Greensboro NC, and American
Cyanamid of Princeton NJ.; Project ID #s include: Exhibit 3 of EPA MRID
447933-01, Terbufos 99-02, EXA 99-004, EXA 99-006, and RES 99-003,
Sponsored by American Cyanamid.
CL92100 (terbufos): Validation of GC/FPD Determinative Methods M3153,
M3154, M3155, and M 3156 For The Determination of CL 92100 Residues In,
Respectively, Whole Body Dosimeters, Aerosol OT Handwash and Glove Wash
Solutions, Air Sampling Tubes and Face/Neck Wipes; (3/26/99) Authored by
Joseph Higham, Jill Cooper, and Rose Sweeney; Completed by ABC Laboratories
of Columbia MO, and American Cyanamid of Princeton NJ.; Project ID #s
include: Exhibit 4 of EPA MRID 447933-01, ABC Report 44703, and RES 99-
003, Sponsored by American Cyanamid.
Occupational Exposure and Risk Assessment For Loaders and Applicators
Handling Terbufos Products and Supporting Worker Exposure Studies; (3/26/99)
Authored by Joseph Higham, Richard Honeycutt, D. Larry Merricks, Rose A.
Sweeney, Cassi L. Walls, and Susan H Youngren; Completed by ABC
Laboratories of Columbia MO, HERAC of Greensboro NC, Agrisearch of
Frederick MD, Novigen Sciences of Washington DC, and American Cyanamid of
Princeton NJ.; Project ID #s include: Exhibit 1 of EPA MRID 447933-01,
Terbufos 99-02, EXA 99-004, EXA 99-006, and RES 99-003, Sponsored by
American Cyanamid
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Appendix E. GENERIC DATA CALL-IN
See table in docket 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.
104
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Appendix F. PRODUCT SPECIFIC DATA CALL-IN
See table in docket 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.
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Appendix G. EPA'S BATCHING OF TERBUFOS 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 reregi strati on of products containing terbufos as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
106
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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.
Three products were found which contain Terbufos as the active ingredient. These products
have been placed into three batches in accordance with the active and inert ingredients and type
of formulation.
The products in Batch 2 may be supported by citing/submitting the acute data from Batch
1.
• The products in Batch 3 may be supported by citing/submitting the acute data from Batch
1.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch
1
IEPA Reg. No.
~~| 241-241
% Active Ingredient
[Formulation Type |
85.0 (Solid 1
Batch
2
IEPA Reg. No.
~~| 241-314
% Active Ingredient
20.0
[Formulation Type |
Isolid |
Batch
3
IEPA Reg. No.
~~| 241-238
% Active Ingredient
15.0
[Formulation Type |
Isolid |
107
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Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN
1) BASF Corporation
108
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Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
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 atwilliams.nicole@epamail.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
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.gov/opprd001/forms/8570-27.pdf
109
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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 Registrants 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 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf
Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
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Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
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
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service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides. You
can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for
the new submission. The identifying number should be used whenever you contact
the Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which
identify the chemical (including "blind" codes used when a sample was submitted
for testing by commercial or academic facilities). Please provide a CAS number if
one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents
are not available electronically, but may be obtained by contacting the person listed on the
respective Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
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