vvEPA
United States Prevention, Pesticides EPA738-R-00-021
Environmental Protection And Toxic Substances March 2001
Agency (7508C)
Re registration
Eligibility Decision for
Trial late
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-00-019
March 2001
R.E.D. FACTS
Pesticide
Reregistration
Trial late
All pesticides sold or distributed in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in scientific
knowledge, the law requires that pesticides which were first registered before
November 1, 1984, be reregistered to ensure that they meet today's more stringent
standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act (FQPA) of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public to
pesticide residues from all sources, and the cumulative effects of pesticides and
other compounds with common mechanisms of toxicity The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 2695,
triallate.
Use Profile
Triallate is a pre-emergent herbicide federally registered, but restricted to use
in CO, ID, KS, MN, MT, NE, NY ND, OR, SD, UT, WA, and WY on barley,
lentils, peas (dried and succulent), triticale, wheat, and canary grass. The Agency
has found that all currently registered uses of triallate, except canary grass, are
eligible for reregistration, provided specified changes are made to the label. Canary
grass is not being supported by the registrant for reregistration and the tolerance has
been revoked. In addition, since completion of the RED, a tolerance has recently
been established for a new use of triallate on sugar beets.
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Regulatory
History
On average, about 2.3 million pounds of triallate are applied annually on 2.1
million acres. Depending on the crop, triallate formulations may be applied before
or after planting, either by ground or aerial equipment. Application is typically
made either in the fall or in the spring, before targeted weed species germinate.
Triallate was first registered as a herbicide in the U.S. in 1961. Because
triallate is a List B chemical, no Registration Standard was prepared. A Data Call-
in (DCI) was issued in 1991 requiring the submission of additional data on product
and residue chemistry, toxicity environmental fate, and ecological effects. In 1993
and 1994, two additional DCIs were issued requiring the submission of a female
mouse oncogenicity study at higher dose levels and a developmental neurotoxicity
study.
Human Health
Assessment
Toxicity
Triallate is a herbicide in the class of thiocarbamates, which includes
pebulate, molinate, EPTC, butylate, vernolate, and cycloate. As with other
chemicals in this class, neurotoxicity is the major toxic effect; however, other toxic
effects, including carcinogenicity were also observed in toxicology studies for this
compound.
Toxicity categories, which range from I (most toxic) to IV (least toxic), show
that triallate has a low order of acute oral (Toxicity Category HI); dermal (Toxicity
Category IV); and inhalation (Toxicity Category IV) toxicity. In primary irritation
studies, triallate produces slight irritation to the eye (Toxicity Category HI) and skin
(Toxicity Category IV), and is a skin sensitizer.
Triallate is classified as a Group C chemical (possible human carcinogen),
based on hepatocellular carcinomas in male mice, with a positive trend and
borderline significance in female mice, and increased incidence of renal tubular cell
adenomas in rats.
Cumulative Risk
In accordance with the FQPA, the Agency is examining whether and to what
extent some or all organophosphorous and carbamate (including, but not limited to,
methyl carbamate, N-methyl carbamate, thiocarbamate, and dithiocarbamate)
pesticides may share a common mechanism of toxicity. In contrast to other
carbamates, the Agency has a less fully developed understanding of whether the
thiocarbamates share a common mechanism of toxicity with other cholinesterase-
inhibiting or carcinogenic chemicals. As a result, the Agency has not determined if it
would be appropriate to include them in a cumulative risk assessment with other
such chemicals (e.g., the organophosphorous and carbamate pesticides).
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Therefore, for the purposes of this risk assessment, the Agency has assumed that
triallate does not share a common mechanism of toxicity with cholinesterase-
inhibiting chemicals.
Dietary Risks
Overall acute and chronic dietary (food only) risks associated with triallate
use on all registered use sites, including the proposed use of triallate on sugar beets,
are not of concern to the Agency. Acute and chronic drinking water concentrations
were also estimated to evaluate the contribution of drinking water to dietary risk.
These drinking water estimates are based on ground and surface water computer
models that predict concentrations for both parent triallate and the metabolite
TCPSA. Aggregating both food and drinking water acute and chronic (non-
cancer) risks, the dietary exposures are not of concern to the Agency.
Triallate is classified as a Group C chemical (possible human carcinogen).
Based on a linear low-dose (Qi*) approach for human cancer risk characterization,
the cancer dietary risk is 7.1 x 10"8, which is less than EPA's target of 1 x 10"6 (1 in
1 million) and, therefore, is not of concern to the Agency.
Although chronic (cancer) dietary (food only) risk is not of concern to the
Agency, aggregating the cancer dietary risk (food) with model estimated drinking
water concentrations is of concern. To address this, the registrant initiated a surface
water monitoring program to measure parent triallate and metabolite TCPSA in high
use areas with vulnerable soil conditions.
Tolerances
Tolerances [refer to 40 CFR 180.314 (c)] or maximum residue limits are
summarized below:
• Revoke 1 tolerance (lentils hay), since it is no longer considered a significant
livestock feed item.
• Add 3 new tolerances (barley hay; wheat forage; wheat hay), due to changes
toOPPTSGLN860.1000.
• The tolerance for peas will apply to lentils.
All other tolerances are to be increased, except barley grain, which will
remain the same.
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Worker Risks
There are potential occupational exposures to pesticide handlers and to
workers when applying triallate. For mixers/loaders, applicators, and flaggers, risks
for all exposure scenarios are not of concern with either personal protective
equipment (PPE) (i.e., gloves and dust/mist filtering respirators) or engineering
controls (enclosed cockpits and trucks). The addition of some of these protective
measures are necessary to reduce cancer risk to handlers.
Significant exposure to triallate during harvesting, or any other late season
activity, is not likely since triallate is applied pre-emergence. Therefore, post-
application exposure is not expected, provided that the current 12-hour restricted-
entry interval (RET) is observed.
Environmental
Assessment
Risk Mitigation
Ecological Risks
The use of triallate is not likely to pose significant risk to birds, fish, large
mammals, reptiles or nontarget insects. Levels of concern are slightly exceeded for
endangered small mammals; however, this risk is dependent upon ingestion of large
amounts of contaminated insects or seed in the diet. Levels of concern for acute
risk, based on water modeling results, are slightly exceeded for endangered aquatic
invertebrates. However, because the habitat of endangered aquatic organisms
where triallate is registered are not likely to be exposed to the high modeled
concentrations of triallate, effects to endangered aquatic invertebrates are not
expected. Additionally, levels of concern for acute risk are exceeded for terrestrial
and semiaquatic plants. Although risks to plants are greater than the level of
concern, the overall ecological risk associated with the use of triallate is low;
therefore, no additional mitigation measures to reduce estimated ecological risks are
necessary.
In order to support a RED for triallate, some risk mitigation measures are
necessary and must be implemented. To address aggregate cancer dietary risk
concerns (food and water), the registrant initiated a surface water monitoring
program to measure parent triallate and metabolite TCPSA in high use areas with
vulnerable soil conditions. A final report of this study is expected in late 2002.
Interim results indicate that surface drinking water concentrations are not of concern
to the Agency.
There are also potential occupational exposures to pesticide handlers and to
workers when applying triallate. For mixers/loaders, applicators, and flaggers, risks
for all exposure scenarios are mitigated with either personal protective equipment
(PPE) (i.e., chemical resistant gloves and dust/mist filtering respirators) or
engineering controls (i.e., enclosed cockpits and trucks).
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Additional Data
Required
EPA is requiring the following additional generic studies for triallate to
confirm its regulatory assessments and conclusions: discussion of formation of
impurities; stability to normal and elevated temperatures, metals, and metal ions;
pH; UV/Visible absorption; partition coefficient; crop field trials (wheat hay);
processed food/feed (barley); field accumulation in rotational crops; aquatic
invertebrate life-cycle (21 day); aquatic plant growth; and surface drinking water
monitoring.
The Agency also is requiring product-specific data, including product
chemistry and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
Product Labeling All triallate end-use products must comply with EPA's current pesticide
Changes product labeling requirements, with the risk mitigation measures discussed above,
Red U i red anc^uses no l°n§er eligible for reregistration should be excluded. For a
comprehensive list of labeling requirements, please see the triallate RED document.
Regulatory
Conclusion
The Agency has found that all currently registered uses of triallate, except
canary grass, are eligible for reregistration, provided specified changes are made to
the label. The use of eligible triallate products in accordance with labeling specified
in this RED will not pose unreasonable adverse effects to humans or the
environment. These products will be reregistered once the required confirmatory
generic data, product specific data, CSFs, and revised labeling are received and
accepted by EPA. Products which contain active ingredients in addition to triallate
will be reregistered when all of their other active ingredients also are eligible for
reregistration.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility Decision
(RED) document for triallate during a 60-day time period, as announced in a Notice
of Availability published in the Federal Register. To obtain a copy of the RED
document or to submit written comments, 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 RED and this fact sheet are available on the Internet.
See http://www.epa.gov/REDs or http://www.epa.gov/pesticides/.
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Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419; telephone 1-800-490-9198; fax 513-489-
8695.
Following the comment period, the triallate RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161; telephone 1-800-553-6847, or 703-605-6000.
For more information about EPA's pesticide reregistration program, the
triallate RED, or reregistration of individual products containing triallate, please
contact the Special Review and Reregistration Division (7508C), OPP, US EPA,
Washington, DC 20460; telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Telecommunications Network (NPTN). Call toll-free 1-800-
858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern
Standard Time, seven days a week. Their internet address is
htto ://ace. orst. edu/info/nptn/.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the
Agency) has completed its review of the available data and public comments received related to the
risk assessment for the thiocarbamate pesticide triallate. Based on its review, EPA has identified risk
mitigation measures that the Agency believes are necessary to address the human health and
environmental risks associated with the current use of triallate. The EPA is now publishing its
reregistration eligibility, risk management, and tolerance reassessment decisions for the current uses of
triallate, and its associated human health and environmental risks. The Agency's decision on the
individual chemical triallate which was approved on August 4, 2000, can be found in the attached
document entitled, "Reregistration Eligibility Decision for Triallate."
A Notice of Availability for this Reregistration Eligibility Decision (RED) for Triallate is published in the
Federal Register. To obtain a copy of the 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 RED and all supporting documents are
available on the Agency's web page www.epa.gov/pesticides and in the Public Docket.
This document and the process used to develop it are the result of a pilot process to facilitate greater
public involvement and participation in the reregistration and/or tolerance reassessment decisions for
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 and to engage the public in the reregistration and tolerance reassessment processes for
these chemicals. In cooperation with the U.S. Department of Agriculture, the Agency held a
teleconference on March 20, 2000, where the results of the revised human health and environmental
effects risk assessments were presented to interested stakeholders. Information discussed during the
call, such as triallate usage and occupational practices, are reflected in this RED. Also, a close-out
conference call was conducted on July 19, 2000 with many of the same participants from the March 20
conference call, to discuss the risk management decisions and resultant changes to the triallate labels.
Please note that the triallate risk assessment and the attached RED concern only this particular
thiocarbamate. While current data are limited, the thiocarbamates, including triallate, appear to be
comparatively weak cholinesterase inhibitors, and the individual chemicals are generally regulated based
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on other dissimilar toxic endpoints from each other and thus, the thiocarbamates do not appear to
exhibit a common mechanism of action within the group of chemicals. At this time, the Agency does
not believe it has sufficient reliable information concerning common mechanism issues to determine
whether or not triallate shares a common mechanism of toxicity with other cholinesterase-inhibiting or
possible human carcinogen chemicals. Therefore, for the purposes of this risk assessment, the Agency
has assumed that triallate does not share a common mechanism of toxicity with cholinesterase-inhibiting
or human carcinogen chemicals.
This document contains a generic and a product-specific Data Call-in (DCI) that outline further data
requirements for this chemical. Note that a complete DCI, with all pertinent instructions, is being sent
to registrants under separate cover. Additionally, the first set of required responses to both DCIs are
due 90 days from the receipt of the DCI letter. The second set of required responses to the product-
specific DCI are due eight months from the date of this letter.
End-use product labels must be revised by the manufacturer to adopt the changes set forth in Section
IV of this document. Instructions for registrants on submitting revised labeling and the time frame
established to do so can be found in Section V of this document. If you have questions on this
document or the label changes necessary for reregistration, please contact the Special Review and
Reregistration Division representative, Dirk Helder at (703) 305-4610. For questions about product
reregistration and/or the Product Data Call-in that accompanies this document, please contact Barbara
Briscoe at (703) 308-8177.
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Reregistration Eligibility Decision
for
Triallate
ListB
Case 2695
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Table of Contents
Glossary of Terms and Abbreviations i
Executive Summary iii
Triallate Reregistration Eligibility Decision Team vi
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 4
C. Use Profile 4
D. Estimated Usage of Pesticide 5
III. Summary of Triallate Risk Assessment 7
A. Human Health Risk Assessment 7
1. Dietary Risk from Food 7
a. Toxicity 7
b. FQPA Safety Factor 9
c. Hazard Determination 9
d. Exposure Assumptions 11
e. Dietary (Food) Risk Assessment 12
2. Dietary Risk from Drinking Water 14
3. Aggregate Risk 16
4. Occupational Risk 17
a. Occupational Toxicity 18
b. Occupational Exposure 20
B. Environmental Risk Assessment 23
1. Fate and Transport 23
2. Water Resources 24
3. Ecological Risks 25
IV. Risk Management and Reregistration Decision 26
A. Determination of Reregistration Eligibility 26
B. Regulatory Position 27
1. Determination of Safety for U.S. Population 27
2. Determination of Safety for Infants and Children 28
3. Endocrine Disrupter Effects 29
4. Cumulative Risks 29
C. Tolerance Reassessment Summary 30
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D. Human Health Risk Mitigation 34
1. Dietary Mitigation 34
2. Occupational Risk Mitigation 36
a. Handler Exposure 36
b. Post-Application Exposure 39
E. Environmental Risk Mitigation 40
F. Other Labeling 40
1. Endangered Species Statement 40
2. Spray Drift Management 41
V. What Registrants Need to Do 41
A. Manufacturing Use Products 42
1. Additional Generic Data Requirements 42
2. Labeling for Manufacturing-Use Products 44
B. End-Use Products 44
1. Additional Product-Specific Data Requirements 44
2. Labeling for End-Use Products 44
C. Labeling Changes Summary Table 45
D. Existing Stocks 52
VL APPENDICES 53
Appendix A. Table of Use Patterns Eligible for Reregistration 54
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 55
Appendix C. Technical Support Documents 59
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision 60
Appendix E. Batching of Triallate Products for Meeting Acute Toxicity Data
Requirements for Reregistration 71
Appendix F. List of Available Related Documents and Electronically Available
Forms 72
Appendix G. Generic Data Call-in 75
Appendix H. Product Specific Data Call-In 81
Appendix I. List of All Registrants Sent This Data Call-In 87
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Glossary of Terms and Abbreviations
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLN Guideline Number
HAFT Highest Average Field Trial
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LOC Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
NA Not Applicable
NAWQA USGS National Water Quality Assessment
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Glossary of Terms and Abbreviations
NPDES National Pollutant Discharge Elimination System
NR Not Required
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/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
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TCPSA 2,3,3-trichloroprop-2-ene sulfonic acid (Triallate Metabolite)
TGAI Technical Grade Active Ingredient
TRR Total Radioactive Residue
USDA United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
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Executive Summary
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of triallate, including the consideration of risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures. The Agency made its reregistration eligibility determination
based on the data required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, and published scientific literature. The Agency has found that all currently
registered uses of triallate, except for canary grass, are eligible for reregistration, provided specified
changes are made to the label. Canary grass is not being supported by the registrant for reregistration
and tolerances have been revoked.
Use Summary
Triallate is a pre-emergent herbicide federally registered, but restricted to use in CO, ID, KS, MN,
MT, ME, NV, ND, OR, SD, UT, WA, and WY on barley, lentils, peas (dried and succulent), triticale,
wheat, and canary grass (seed crop only). In addition, a tolerance petition for sugar beets is currently
pending. On average, about 2.3 million pounds of triallate are applied annually on 2.1 million acres.
Depending on the crop, triallate formulations may be applied before or after planting, either by ground
or aerial equipment. Application is typically made either in the fall or in the spring, before targeted
weed species germinate.
Dietary Risks
Triallate is a herbicide in the class of thiocarbamates, which includes pebulate, molinate, EPTC,
butylate, vernolate, and cycloate. As with other chemicals in this class, neurotoxicity is the major toxic
effect; however, other toxic effects, including carcinogenicity were also observed in toxicology studies
for this compound.
Overall acute and chronic dietary (food only) risks associated with triallate use on all registered use
sites, including the proposed use of triallate on sugar beets, are not of concern to the Agency. The
Agency based its dietary exposure assessment on a refined Tier 3-Monte Carlo probabilistic analysis
with anticipated residues and percent of crop treated data. Acute and chronic drinking water
concentrations were also estimated to evaluate the contribution of drinking water to dietary risk. These
drinking water estimates are based on ground and surface water computer models that predict
concentrations for both parent triallate and the metabolite TCPSA. Aggregating both food and drinking
water acute and chronic (non-cancer) risks, the dietary exposures are not of concern to the Agency.
Triallate is classified as a Group C chemical (possible human carcinogen), based on hepatocellular
carcinomas in male mice, with a positive trend and borderline significance in female mice, and increased
incidence of renal tubular cell adenomas in rats. The Agency utilized a low-dose (Qi*) approach to
characterize human cancer risk. Although chronic (cancer) dietary (food only) risk is not of concern to
the Agency, aggregating the cancer dietary risk (food) with model estimated drinking water
concentrations is of concern. To address this, the registrant initiated a surface water monitoring
iii
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program to measure parent triallate and metabolite TCPSA in high use areas with vulnerable soil
conditions. A final report of this study is expected in late 2002.
Worker Risks
There are potential occupational exposures to pesticide handlers and to workers when applying
triallate. For mixers/loaders, applicators, and flaggers, risks for all exposure scenarios are mitigated
with either personal protective equipment (PPE) (i.e., gloves and dust/mist filtering respirators) or
engineering controls (enclosed cockpits and trucks). The addition of some of these protective
measures are necessary to reduce cancer risk to handlers.
Significant exposure to triallate during harvesting, or any other late season activity, is not likely since
triallate is applied pre-emergence. Therefore, post-application exposure is not expected, provided that
the current 12-hour restricted-entry interval (REI) is observed.
Ecological Risks
The use of triallate is not likely to pose significant risk to birds, fish, large mammals, reptiles or nontarget
insects. Levels of concern are slightly exceeded for endangered small mammals; however, this risk is
dependent upon ingestion of large amounts of contaminated insects or seed in the diet. Levels of
concern for acute risk, based on water modeling results, are slightly exceeded for endangered aquatic
invertebrates. However, because the habitat of endangered aquatic organisms where triallate is
registered are not likely to be exposed to the high modeled concentrations of triallate, effects to
endangered aquatic invertebrates are not expected. Additionally, levels of concern for acute risk are
exceeded for terrestrial and semiaquatic plants. Although risks to plants are greater than the level of
concern, the overall ecological risk associated with the use of triallate is low; therefore, no additional
mitigation measures to reduce estimated ecological risks are necessary.
Cumulative Risk
In accordance with the Food Quality Protection Act (FQPA), the Agency is examining whether and to
what extent some or all organophosphorous and carbamate (including, but not limited to, methyl
carbamate, N-methyl carbamate, thiocarbamate, and dithiocarbamate) pesticides may share a common
mechanism of toxicity. In contrast to other carbamates, the Agency has a less fully developed
understanding of whether the thiocarbamates share a common mechanism of toxicity with other
cholinesterase-inhibiting or carcinogenic chemicals. As a result, the Agency has not determined if it
would be appropriate to include them in a cumulative risk assessment with other such chemicals (e.g.,
the organophosphorous and carbamate pesticides). Therefore, for the purposes of this risk assessment,
the Agency has assumed that triallate does not share a common mechanism of toxicity with
cholinesterase-inhibiting chemicals.
IV
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More detailed information can be found in the technical supporting documents for triallate referenced in
this reregistration eligibility decision document. 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,
and in the Public Docket.
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Triallate Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
George Keitt
Istanbul Yusuf
Herbicide and Insecticide Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Amer Al-Mudallal
Jim Hetrick
Kevin Costello
Brian Montague
Health Effects Risk Assessment
Jose Morales
Seyed Tadayon
Michelle Centra
Julianna Cruz
Registration Support
Jim Tompkins
Risk Management
Michael L. Goodis
Kathleen Meier
Dirk Helder
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch I
Reregistration Branch HJ
Chemistry and Exposure Branch I
Reregistration Branch HJ
Reregistration Branch HJ
Herbicide Branch
Reregistration Branch U
Reregistration Branch U
Reregistration Branch U
VI
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate
the reregistration of products with active ingredients registered prior to November 1, 1984. The
amended Act calls for the development and submission of data to support the reregistration of an active
ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether or not 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 that by 2006, EPA must review all tolerances in effect on the day before the
date of the enactment of the FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act
(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.
The Food Quality Protection Act requires that the Agency consider the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity." The
Agency is examining whether and to what extent some or all organophosphorous and carbamate
pesticides may share acetylcholinesterase inhibition as a common mechanism of toxicity. In contrast to
other carbamates, the Agency has a less fully developed understanding of whether or not the
thiocarbamates share acetylcholinesterase inhibition as a common mechanism of toxicity with other
cholinesterase-inhibiting chemicals. While current data are limited, the thiocarbamates appear to be
comparatively weak cholinesterase inhibitors and are generally regulated based on other dissimilar toxic
endpoints. At this time, the Agency does not believe it has sufficient reliable information concerning
common mechanism issues to determine whether or not triallate, a thiocarbamate, shares a common
mechanism of toxicity with other cholinesterase-inhibiting or possible human carcinogen chemicals.
Therefore, for the purposes of this risk assessment, the Agency has assumed that triallate does not
share a common mechanism of toxicity with cholinesterase-inhibiting or human carcinogen chemicals.
Similarly, the Agency is examining whether and to what extent some or all pesticides that may be human
carcinogens may also share a common mechanism of toxicity. Current information on the common
mechanism of toxicity for possible or probable human carcinogens is limited, and the Agency's
understanding of this relationship needs to be further developed. As a result, the Agency has not
determined if it would be appropriate to include them in a cumulative risk assessment with other human
carcinogen chemicals.
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of triallate, including the consideration of risk to infants and children for any potential dietary,
1
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drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA. In an
effort to simplify the RED, the information presented herein is summarized. More detailed information
can be found in the technical supporting documents for triallate referenced in this RED. 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, and in the Public Docket. This document consists of six
sections. Section I is the introduction. Section n provides a profile of the use and usage of triallate,
and its regulatory history. Section m gives an overview of the human health and environmental
assessments, based on the data available to the Agency. Section IV presents the reregistration
eligibility and risk management decisions. Section V summarizes the label changes necessary to
implement risk mitigation measures outlined in Section IV. Finally, the Appendices list all related
documents and how to access them, and Data Call-in (DCI) information.
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II. Chemical Overview
A. Regulatory History
Triallate has been registered in the United States since 1961 for use as a herbicide. A Data Call-In
(DCI) was issued in 1991 for triallate requiring the submission of additional data on product and
residue chemistry, toxicity, environmental fate, and ecological effects. Because triallate is a List B
chemical, no Registration Standard was prepared. However, in 1993 and 1994, two additional DCIs
were issued requiring the submission of a female mouse oncogenicity study at higher dose levels and a
developmental neurotoxicity study, respectively. Also, the Agricultural Data Call-in (AGDCI) was
issued in 1995, requiring foliar residue dissipation data on products that are foliarly applied and transfer
coefficients to develop restricted entry intervals for workers. In response, Monsanto modified its
product label (Registration No. 524-307) to restrict use to a pre-emergent or pre-plant soil application
to remove it from the scope of the AGDCI. On March 24, 1998, following review and approval of the
changed product label, the Agency waived the guideline requirements of the AGDCI for triallate
products. This Reregistration Eligibility Decision (RED) reflects a reassessment of all data which were
submitted in response to the DCIs.
The Agency is currently reviewing a petition to establish tolerances for triallate use on sugar beets. The
decision of whether or not to grant tolerances for sugar beet use is outside the scope of this RED, and
will be made separately by the Agency. However, to assist in the decision-making process on whether
or not to grant tolerances for triallate use on sugar beets, the dietary assessment in this RED, including
the calculations of the Drinking Water Levels of Comparison (DWLOCs), includes the proposed use of
triallate on sugar beets.
Also, in an effort to promote transparency of the reregistration process and public understanding of and
participation in regulatory decisions, the Agency, in cooperation with the U.S. Department of
Agriculture (USDA), has modified the reregistration process. This modified process provides
opportunities for stakeholders to ask questions about and provide input to the risk assessment and risk
mitigation strategies, via conference calls and other formats. Consistent with this process, a conference
call was conducted on March 20, 2000 with EPA, USDA, the registrant, and other stakeholders (i.e.,
growers, commodity groups, land grant universities, and others) to discuss the basis of the calculated
risks of triallate, and the Agency's resultant risk concerns. Information discussed during the call, such
as triallate usage and occupational practices, are reflected in this RED. Also, a close-out conference
call was conducted on July 19, 2000 with many of the same participants from the March 20 conference
call, to discuss the risk management decisions and resultant changes to the triallate labels.
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B. Chemical Identification
CH
Cl
TT
0 Cl
Triallate technical is an amber to dark brown solid with a melting point of 29-30 °C, specific gravity of
1.2600-1.2624 at 35 °C, octanol/water partition coefficient (log Kow) of 4.54, and vapor pressure of
1.1 x 10"4 mm Hg at 25 °C. Triallate is slightly soluble in water (4 ppm at 25 °C), and is soluble in
methylene chloride, n-octanol, and toluene at >200 g/100 mL.
! Common Name: Triallate
! Chemical Name: S-2,3,3-trichloroallyl diisopropylthiocarbamate
! Chemical Family: Thiocarbamate
! CAS Registry Number: 2303-17-5
! OPP Chemical Code: 078802
! Empirical Formula: C10H16C13NOS
! Trade Name: Far-Go®, Buckle®, and Avadex BW®
! Basic Manufacturer: Monsanto Company
C. Use Profile
The following is information on the currently registered uses with an overview of use sites and
application methods. A detailed table of the uses of triallate eligible for reregistration is contained in
Appendix A.
Type of Pesticide
Triallate is a pre-emergent selective herbicide for general use.
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Use Sites
Triallate is federally registered, but restricted to use in Colorado, Idaho, Kansas, Minnesota, Montana,
Nebraska, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming on
barley, lentils, peas (dried and succulent), triticale, and wheat. The only non-food/non-feed use is
canary grass (seed crop only); however, canary grass is not being supported by the registrant for
reregistration and tolerances have been revoked. A tolerance petition for sugar beets is currently
pending. There are no existing or proposed residential uses for triallate products.
Target Pests
Wild oat, bromegrass, Japanese brome, cheat, downy brome, yellow foxtail, pigeongrass, green foxtail,
annual ryegrass
Formulation Types Registered
Triallate is sold in the United States under the trade names Far-Go®, Buckle®, and Avadex BW®.
The 10% granular (G) for Far-Go® and Buckle®, and the 4 Ib/gal emulsifiable concentrate (EC) for
Far-Go® are the only triallate formulations registered for food/feed uses. Although Avadex BW® is
registered in the United States, it is currently only sold in Canada. Moreover, the Buckle® granular
formulation contains 10% triallate and 3% trifluralin.
Method and Rates of Application
Triallate may be applied by groundboom, tractor-drawn spreader, fixed-wing aircraft, and soil
incorporation equipment.
Depending on the crop, triallate formulations may be applied, either by ground or aerial equipment, at
application rates of 1.0-1.5 Ib ai/acre; either before or after planting; as a surface broadcast (no-till) or
incorporated in the soil. A very small percentage of the granular triallate formulation (<1 % of total
triallate products produced) are aerially applied.
Timing of Application
Application is typically made either in the fall (70%) or in the spring (30%) before targeted weed
species germinate. Typically, the products are immediately incorporated into the soil to minimize
volatilization. However, surface application of the granular formulation is also allowed with delayed
incorporation or without incorporation in no-till systems, which helps prevent soil erosion in some
cases. The EC formulated products require immediate soil incorporation for all applications.
D. Estimated Usage of Pesticide
Table 1 below summarizes the best available estimates for the pesticide uses of triallate. These
estimates are derived from a variety of published and proprietary sources available to the Agency. 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.
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Table 1. Triallate Usage Summary
Site
Barley
CRPA
Lots, Farmsteads, etc.
Peas (dry) and lentils
Peas (green)
Summer Fallow
Wheat (spring)
Wheat (winter)
Totals
Acres
Grown
(000)
7,505
34,308
24,815
249
386
29,040
20,799
45,854
Acres Treated
(000)
Wtd
Avg
653
3
11
33
16
73
1,155
200
2,144
Est
Max
1,000
7
63
75
47
175
1,753
283
% of Crop
Treated (000)
Wtd
Avg
9
0
0
13
4
0
6
0
Est
Max
13
0
0
30
12
1
8
1
Lbs ai Applied
(000)
Wtd
Avg
710
7
11
41
16
84
1,110
270
2,249
Est
Max
1,088
14
63
94
47
196
1,684
541
Average Application
Rate
Ibai/
A/yr
1.1
2.0
1.0
1.3
1.0
1.2
1.0
1.3
#appl
/yr
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.1
Ibai/A
/app
1.1
2.0
1.0
1.3
1.0
1.1
1.0
1.2
States of Most Usage
(% of total ai used on
this site)
MT,ID,ND,WA81%
ND 97%
GA 100%
ID, WA 89%
WA, OR 96%
WA,MT91%
ND, MT, MN 90%
MT, WA 84%
CRPA = Conservation Reserve Program Acres
COLUMN HEADINGS
Wtd Avg = Weighted average—the most recent years and more reliable data are weighted more heavily. Wtd Avg % of crop treated used for chronic (cancer and
non-cancer) dietary risk assessment.
Est Max=Estimated maximum, which is estimated from available data. Est Max % of crop treated used for acute dietary risk assessment.
Average application rates are calculated from the weighted averages.
NOTES ON TABLE DATA
Usage data primarily covers 1987 - 1996.
Calculations of the above numbers may not appear to agree because they are displayed as rounded:
- to the nearest 1000 for acres treated or Ib. ai (Therefore 0 = < 500)
- to the nearest whole percentage point for % of crop treated. (Therefore 0% = < 0.5%)
SOURCES
EPA data (1987-1996), USDA/NASS (1990-1996), California (1993-1995)
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III. Summary of Triallate Risk Assessment
The following is a summary of EPA's human health and ecological risk findings and conclusions for the
thiocarbamate pesticide triallate, as presented fully in the documents: Triallate-HED Reregistration
Eligibility Document, April 18, 2000, and Reregistration Eligibility Document for Triallate
Environmental Fate and Effects Chapter, September 30, 1999. Since the completion of the
Environmental Fate and Effects Risk Assessment, the Agency made changes in its assessment of
surface water concentrations of triallate and its metabolite TCPSA. Specifically, the Agency has
included the use of the Index Reservoir (IR) and Percent Crop Area (PC A) in the Tier n PRZM-
EXAMS surface water model simulations. These changes are described in the Agency's December
22, 1999 and March 28, 2000 memoranda from the Environmental Fate and Effects Division.
The purpose of this decision document is to summarize the key features and findings of this risk
assessment in order to help the reader better understand the conclusions reached in the assessment.
While the risk assessments and related addenda are not included in this document, they are available on
the Agency's web page www.epa.gov/pesticides, and in the Public Docket.
A. Human Health Risk Assessment
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is
complete, and that it supports a reregistration eligibility determination for all currently registered uses.
Triallate has a low order of acute oral toxicity and is classified as a Toxicity Category III, based
on test results that indicate the LD50 (males) = 3612 mg/kg; LD50 (females) = 3455 mg/kg; and LD50
(combined) = 3382 mg/kg (MRID No. 44660701). The Agency has determined that only triallate and
its metabolite 2,3,3-trichloroprop-2-ene sulfonic acid (TCPSA) should be regulated and assessed for
dietary exposure in plant commodities. The Agency decided to regulate on the TCPSA metabolite
because it is present at more than 10% of the total radioactive residue (TRR) in the plant metabolism
studies, and in the absence of lexicological data for this metabolite, the same toxicity as the parent
compound was assumed.
A brief overview of the toxicity studies used for the dietary risk assessment is outlined in Table 2 in this
document. Further details on the toxicity of triallate can be found in the Hazard Characterization
section of the April 18, 2000 Human Health Risk Assessment.
Acute Dietary
For the general population, the No Observed Adverse Effect Level (NOAEL) of 60 mg/kg/day was
established based on decreased mean body weight, altered motor activity, and changes in functional
7
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observation battery (FOB) in the rat acute neurotoxicity study at the Lowest Observed Adverse Effect
Level (LOAEL) of 300 mg/kg/day. Because of the neurotoxic characteristics of triallate (altered motor
activity observed in both sexes 7 hours after treatment at the mid- and high-doses that persisted up to
14 days in high-dose females), this endpoint is considered appropriate for assessing risk in the general
population.
For the females 13-50 years population subgroup, the NOAEL of 5 mg/kg/day was established based
on increased skeletal malformations/variations in the rabbit developmental toxicity study at the LOAEL
of 15 mg/kg/day. The skeletal malformations are presumed to occur after a single exposure (dose),
and thus, are appropriate for this (acute) risk assessment. In addition, skeletal malformations
(malaligned sternebrae) were also seen in rat fetuses following in utero exposure to triallate.
Chronic (Non-Cancer) Dietary
The NOAEL of 2.5 mg/kg/day was established based on decreased survival in males and females,
decreased mean body weights in males, and increased adrenal weights in males in the 2-year chronic
toxicity/carcinogenicity study in rats at the LOAEL of 12.5 mg/kg/day. Although a 2-year chronic
toxicity study in dogs was conducted, the dose and endpoint selection is based on the rat study,
because the systemic toxicity observed is more suitable for deriving the reference dose (RfD). In the 2-
year study with dogs, the NOAEL was 1.275 mg/kg/day and the LOAEL was 4.25 mg/kg/day based
on increased hemosiderin deposition, serum alkaline phosphatase and liver weight observed in female
dogs. The Agency concluded that the dog study is not suitable for deriving the RfD, because: 1)
hemosiderin deposition is a non-specific finding and cannot be correlated to other pathological findings;
2) the alkaline phosphatase levels observed in female dogs were all within biologically normal ranges; 3)
alkaline phosphatase is a non-specific enzyme and is not indicative of liver pathology or biliraistais
unless these increases are four times higher than normal and/or accompanied with increases in liver
specific enzymes; 4) the increases in liver weights were not corroborated with histopathological lesions
in the liver, and 5) these endpoints are not suitable for regulatory purposes.
Chronic (Cancer) Dietary
Triallate is classified as a Group C chemical - possible human carcinogen. This classification is based
on the following factors: (i) hepatocellular carcinomas found in male mice at minimally adequate doses,
with a positive trend and a borderline significant increase in females at inadequate doses; (ii) the
increased incidence in male rats of renal tubular cell adenoma (a rare tumor type) above historical
control levels was considered biologically significant, although no absolute pair-wise statistical
significance was found; (iii) triallate is considered a mutagen because of positive genotoxicity results in
Salmonella typhimurium, mouse lymphoma cells and Chinese hamster cells; and (iv) triallate is
structurally related to several carcinogenic analogs, such as sulfallate, Telone n, and dichlorvos.
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b. FQPA Safety Factor
The FQPA safety factor was retained for triallate because, there is quantitative evidence of increased
susceptibility in the prenatal developmental toxicity study in rabbits; developmental effects (decreased
fetal body weight and increased incidence of malaligned sternebrae) were observed in the absence of
maternal toxicity. However, the FQPA safety factor was reduced to 3x because:
• the toxicology data base is complete;
• increased susceptibility was observed in only one species (rabbits);
• there is no quantitative or qualitative indication of increased susceptibility in the prenatal
developmental toxicity study in rats, the two-generation reproduction study in rats, or
the developmental neurotoxicity study in rats;
• there was no evidence of abnormalities to the fetal nervous system in the developmental
neurotoxicity study in rats; and
• adequate data are available or conservative modeling assumptions are used to assess
dietary food and drinking water exposure (the only components of an aggregate
exposure assessment needed for this pesticide).
The FQPA safety factor for triallate is only applicable to the females 13 -50 population subgroup
because the effects of concern (observed in the prenatal developmental toxicity study in rabbits) occur
in utero and not during post-natal exposure. Moreover, the FQPA safety factor for triallate is only
applicable to acute dietary risk assessment, because the effects of concern were observed only during
in utero exposure and are presumed to occur after a single (acute) exposure.
c. Hazard Determination
The Population Adjusted Dose (PAD) is a relatively new 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 safely factor (SF). Where the FQPA SF has been removed (equivalent to Ix),
the acute or chronic RfD is identical to the acute or chronic PAD. In the case of triallate, the FQPA SF
has been removed (equivalent to a factor of Ix), except for the acute dietary risk assessment for the
females 13-50 years population subgroup. For this subgroup, the acute PAD is adjusted to account for
the 3x FQPA SF. A risk estimate that is less than 100% of the acute or chronic PAD does not exceed
the Agency's risk concern.
Acute PAD
An acute RfD of 0.60 mg/kg/day was derived for the general population (including adult males, infants
and children), based on the NOAEL of 60 mg/kg/day in the acute neurotoxicity study and an
uncertainty factor (UF) of 100 (1 Ox for inter-species extrapolation and lOx for intra-species variation).
The FQPA SF was removed (equivalent to a factor of Ix) for this population. Consequently, the acute
PAD is identical to the acute RfD at 0.60 mg/kg/day for the general population.
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An acute RfD of 0.05 mg/kg/day was derived for the females 13-50 years subpopulation group, based
on the NOAEL of 5 mg/kg/day in the developmental toxicity study in rats and an UF of 100 (1 Ox for
inter-species extrapolation and lOx for intra-species variation). The 3x FQPA SF was retained since
the in utero endpoint is appropriate for this population subgroup (females 13-50 years). Thus, the
acute PAD is 0.017 mg/kg/day.
Chronic (Non-Cancer) PAD
A chronic (non-cancer) RfD of 0.025 mg/kg/day, based on a NOAEL of 2.5 mg/kg/day in the 2-year
chronic toxicity/carcinogenicity study in rats and an UF of 100 (lOx for inter-species extrapolation and
lOx for intra-species variation). The FQPA SF was removed (equivalent to a factor of Ix) for chronic
exposures. Consequently, the chronic PAD is identical to the chronic RfD at 0.025 mg/kg/day.
Chronic (Cancer)
Triallate is classified as a Group C chemical (possible human carcinogen), based on hepatocellular
carcinomas in male mice, with a positive trend and borderline significance in female mice, and increased
incidence of renal tubular cell adenomas in rats. A linear low-dose (Qi*) approach was used to
characterize human health risk. The unit risk, Qx* based on the hepatocellular carcinomas in male mice,
is 7.17 x 10"2 (mg/kg/day)"1 in human equivalents.
The Agency considered the female mouse study to be inadequate, because the prior dosing was judged
to be too low. The registrant has been given the option to repeat this study or to have the cancer risk
assessment based on the low-dose extrapolation model (Qi*) based on the male mice liver tumor. If
the registrant chooses to repeat the study, the decision on cancer risk assessment will be deferred until
completion and evaluation of the new study. The Agency is confident that the low-dose extrapolation
model (Qi*), based on the effects in the male mice, is a conservative enough approach to adequately
characterize triallate human health cancer risk. At this time, the registrant has chosen not to repeat this
study. Therefore, in the absence of any additional relevant data, the Qj* based on the induction of liver
tumors in the male mouse was used to assess cancer risk.
The doses, toxicity endpoints selected, and supporting studies for various dietary exposure scenarios
are summarized in Table 2.
10
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Table 2. Summary of Triallate Dietary Toxicity Endpoints
Exposure
Scenario
Acute Dietary
(Females
13-50 years)
Acute Dietary
(General
Population)
Chronic
(non cancer)
Dietary
Chronic
(cancer)
Dietary
Dose
(mg/kg/day)
NOAEL=5
UF=100
FQPA SF=3
Endpoint
Increased skeletal malformations/variations.
Study
(MRID No.)
Developmental- Rabbit
(43315001)
Acute RfD = 0.05 mg/kg/day Acute PAD=0.017 mg/kg/day
NOAEL=60
UF=100
FQPASF=1
Decreased mean body weight; altered motor
activity; and changes in functional observation
battery (FOB).
Acute Neurotoxicity-
Rat
(42908101)
Acute RfD=0.60 mg/kg Acute PAD=0.60 mg/kg/day
NOAEL=2.5
UF= 100
FQPASF=1
Decreased survival (• +• ) decreased mean body
weights (• ) and increased adrenal weights (• ).
Chronic Toxicity/
Carcinogenicity-Rat
(40384701)
Chronic RfD = 0.025 mg/kg/day Chronic PAD=0.025 mg/kg/day
Group C - "Possible human carcinogen" - Qi* = 7.17 x 10~2 (mg/kg/day)"1 in human
equivalents [converted from animals to humans by use of the (mg/kg body weight)'7' cross
species scaling factor).
d. Exposure Assumptions
The dietary (food) exposure analysis is a refined Tier 3 approach based on the Dietary Exposure
Evaluation Model (DEEM™). The DEEM™ analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-91 Continuing Surveys for Food Intake by Individuals
(CSFn) and accumulated exposure to the chemical for each commodity.
For all dietary analyses, anticipated residues (ARs) and percent of crop treated data were used. Since
wheat, barley, and dry peas are considered blended commodities, the ARs for chronic and acute
analyses are the same. For the purposes of this assessment, residue field trial data were used for the
chronic and acute AR calculations. USDA Pesticide Data Program (PDF) monitoring data were
available for wheat; however, these data were not used for the AR calculation for wheat, because PDF
does not analyze for the TCPSA metabolite. All of the samples analyzed by PDF reported non-
detectable residues of parent triallate. Field trial samples were analyzed for both triallate and the
TCPSA metabolite, and there were measurable residues in these. FDA monitoring data for peas are
also available. However, these data were not used in the AR calculation for peas, because very few
samples were analyzed, and analyses determined the parent compound only. All of the samples
showed non-detectable residues. Available field trial data for peas also analyzed the TCPSA
metabolite, resulting in measurable residues. For more information on the parameters and assumptions
used for assessing dietary risks, see the Dietary Exposure section of the April 18, 2000 Human Health
Risk Assessment.
11
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As noted above, the Agency is currently reviewing a petition to establish tolerances for triallate use on
sugar beets. While the decision on whether or not to grant tolerances for sugar beet use will be made
separately from this RED, to assist in that decision making process, the dietary assessment in this RED
includes the proposed use of triallate on sugar beets. Field trials on sugar beets were provided as part
of the petition, and were used to assess the contribution of triallate use on sugar beets in the dietary
exposure analysis.
e. Dietary (Food) Risk Assessment
Acute Dietary Risk
Acute dietary risk is calculated considering what is eaten in one day (in this instance, the full range of
consumption values as well as the range of residue values in food). A risk estimate that is less than
100% of the acute Population Adjusted Dose (PAD) (the dose at which an individual could be exposed
on any given day and no adverse health effects would be expected) does not exceed the Agency's level
of concern. The acute PAD is the reference dose (RfD) adjusted for the FQPA safety factor.
A probabilistic (Monte Carlo) acute dietary analysis was conducted for triallate. This analysis is highly
refined (Tier 3), and represents a realistic estimate of possible acute dietary exposure using the available
residue data. The assessment is based on all uses supported through reregistration and the proposed
use of triallate on sugar beets. The results of the acute analysis at the 99.9th percentile are presented in
Tables.
Table 3 Acute Dietary Risk (Food Only)
Population Subgroup
U.S. Population
Females (13+, nursing)
Children (1-6 years)
All infants (< 1 year)
Exposure (mg/kg/day)
0.000268
0.000305
0.000650
0.000736
% aPAD
<1
1.8
<1
<1
As indicated in Table 3, the risk estimates are significantly below the Agency's level of concern
(<100% of the acute PAD) for acute dietary exposure for all population subgroups at the 99.9th
percentile. For more information on acute dietary risk assessment, see the Dietary Exposure and Risk
Analysis section of the April 18, 2000 Human Health Risk Assessment.
Chronic (Non-Cancer) Dietary Risk
Chronic (non-cancer) dietary risk is calculated by using the average consumption values for food and
average residue values for those foods over a 70-year lifetime. A risk estimate that is less than 100%
of the chronic PAD (the dose at which an individual could be exposed over the course of a lifetime and
12
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no adverse health effects would be expected) does not exceed the Agency's level of concern. The
results of the analysis, based on the uses supported through reregistration and the proposed use of
triallate on sugar beets, are summarized in Table 4.
Table 4. Chronic (Non-cancer) Dietary Risk (Food Only)
Subgroups
U.S. Population
Females (13+, nursing)
Children (1-6 years)
STon-nursing infants (<1 year)
Exposure (mg/kg/day)
0.000001
0.000002
0.000003
0.000003
%cPAD
<1%
<1%
<1%
<1%
As indicated in Table 4, the chronic (non-cancer) dietary risk (food) does not exceed the Agency's
level of concern (<100% of the chronic PAD) for the general U.S. population and all subgroups. For
more information on chronic dietary risk assessment, see the Dietary Exposure and Risk Analysis
section of the April 18, 2000 Human Health Risk Assessment.
Chronic (Cancer) Dietary Risk
Chronic (cancer) dietary risk is calculated by using the average consumption values for food and
average residue values for those foods over a 70-year lifetime. The chronic exposure value is
combined with a linear low-dose approach (Qi*) to determine the lifetime (cancer) risk estimate.
Triallate is classified as a Group C chemical (possible human carcinogen), based on hepatocellular
carcinomas in male mice, with a positive trend and borderline significance in female mice, and increased
incidence of renal tubular cell adenomas in rats. A linear low-dose (Qi*) approach was used to
characterize human health risk. The unit risk, Qx* based on the hepatocellular carcinomas in male
mice, is 7.17 x 10"2 (mg/kg/day)"1 in human equivalents. The method to calculate cancer dietary risk for
triallate is provided below Table 5.
Table 5. Cancer Dietary Risk
Subgroup
U.S. Population
Exposure
(mg/kg/day)
0.000001
Lifetime Risk
Estimate1
7.1xlO-8
70-year Lifetime Exposure (mglkglfotf x Q,*
(7.17 x
• (o.oooooi
The Agency generally considers 1 x 10"6 (1 in 1 million) or less as negligible risk for cancer dietary
exposure. The results of this analysis indicate that the cancer dietary (food) risk of 7. 1 x 10"8,
associated with the uses supported through reregistration and the proposed use of triallate on sugar
13
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beets, is below the Agency's level of concern for food alone. For more information on chronic
(cancer) dietary risk assessment, see the Dietary Exposure and Risk Analysis section of the April 18,
2000 Human Health Risk Assessment.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground and surface water contamination.
EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or
actual monitoring data, if available, to estimate those risks. To determine the maximum contribution
from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed
by food and then determines a "drinking water level of comparison" (DWLOC) to ascertain whether or
not modeled or monitoring estimated environmental concentrations (EECs) exceed this level. EECs
that are above the corresponding DWLOC exceed the Agency's level of concern. Modeling is
generally considered to be an unrefined assessment and provides high-end estimates.
The drinking water assessment for triallate was conducted on parent triallate and its metabolite TCPSA.
TCPSA was included in the water assessment because it is included in the tolerance expression for
triallate. While monitoring data from surface and ground water sources are available on parent triallate,
none are available on the metabolite TCPSA. Given the uncertainties in TCPSA fate and transport,
and that pesticides with similar properties (high mobility and moderate persistence) are found in drinking
water, the Agency has based its drinking water assessment on the model estimates. Since the triallate
uses on spring and winter wheat are expected to yield the highest EECs in surface and ground waters,
these crop scenarios were used to predict triallate and TCPSA concentrations in ground and surface
waters. Additionally, all drinking water model estimates are based on the maximum application rate of
1.5 Ibsai/acre.
Surface Water
Surface drinking water concentrations were estimated using the PRZM/EXAMS (Tier n) computer
model with the Index Reservoir and Percent Crop Area. The Index Reservoir was developed from a
real watershed in western Illinois, and is used as a standard watershed that is combined with variables
representing characteristics of local soils, weather, and cropping practices to represent a vulnerable
watershed that could support a drinking water supply. Tier n PRZM-EXAMS modeling predicts that
the maximum total triallate residue (triallate + TCPSA) concentration in surface water is not likely to
exceed 9.45 ppb for peak (acute) concentration and 1.26 ppb for 36-year annual mean (chronic:
cancer and non-cancer) concentrations.
In comparison, non-targeted surface water monitoring data from the USGS National Water Quality
Assessment (NAWQA) program indicate that chronic concentrations of triallate (parent only) in
laboratory filtered surface waters from high use triallate areas are substantially lower than PRZM-
EXAMS predictions. The maximum time-weighted annual mean concentration of triallate (parent only)
in surface water is 0.077 ppb. Surface water data from Canadian monitoring studies on unfiltered
14
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surface waters show a similar pattern. There are no surface water monitoring data for TCPSA to
assess runoff potential from actual triallate use.
Ground Water
Ground drinking water concentrations were estimated using the SCI-GROW (Tier I) computer model.
Model simulations indicate that the maximum total triallate residue (triallate + TCPSA) concentrations
are not likely to exceed 0.21 ppb. Triallate is not reported as an analyte in the EPA Pesticides in
Ground Water Database, and there were no reported ground water detections of triallate in the
STORET database. Recent data from the non-targeted USGS NAWQA program indicate that there
have been five detections of triallate in shallow ground water. The detected concentrations ranged
between 0.001- 0.002 ppb. However, it should be noted that none of these detections were in aquifers
that are considered to be major suppliers of drinking water, nor do they reflect any treatment of
drinking water sources. Additionally, the reported NAWQA detections for parent triallate are
approximately an order of magnitude lower than the SCI-GROW model prediction (0.02 ppb).
Environmental fate data for triallate suggest that triallate is not expected to move into ground water
because of moderately high sorption affinity to soil (low mobility) and low to moderate persistence. In
contrast, TCPSA exhibits fate properties of pesticides (high mobility and moderate persistence) found
in ground water. There are, however, no ground water monitoring data for TCPSA to assess leaching
potential under actual use conditions.
The results of both surface and ground water model estimates and their comparison with the DWLOCs
are summarized in Table 6. For more information on drinking water risks and the calculations of the
DWLOCs, see the Water Exposure section of the April 18, 2000 Human Health Risk Assessment, the
Water Resource Assessment of the September 30, 1999 Environmental Fate and Effects Risk
Assessment, and the Agency's December 22, 1999 and March 28, 2000 memoranda amending the
Tier IIPRZM-EXAMS surface water model simulations.
Table 6. Drinking Water DWLOC and EEC Comparisons (Triallate + TCPSA)
Population
Subgroup
U.S. General
Population
Children
(1-6 years)
Females
(13+ nursing)
DWLOCs (ppb)
Acute
21,000
6,000
500
Chronic
Non-Cancer
875
250
750
Cancer
0.45
EECs (ppb)
Ground
Water
0.21
Surface Water
Acute
4.23
(2" incorporation)
9.45
(no incorporation)
Chronic
(Non-Cancer/Cancer)
0.57
(2" incorporation)
1.26
(no incorporation)
For acute risk, potential (peak) concentrations of triallate + TCPSA in either ground water (0.21 ppb)
or surface water for no incorporation (9.45 ppb) result in exposure that is below the Agency's level of
15
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concern for females 13+ nursing (acute DWLOC = 500 ppb), the population subgroup with the highest
risk estimate.
For chronic (non-cancer) risk, potential (average) concentrations of triallate + TCPSA in either
ground water (0.21 ppb) or surface water for no incorporation (1.26 ppb) results in exposure that is
below the Agency's level of concern for children 1-6 years old (chronic non-cancer DWLOC = 250
ppb), the most exposed population subgroup.
For chronic (cancer) risk, potential (average) concentrations of triallate + TCPSA in ground water
(0.21 ppb) result in exposure that is below the Agency's level of concern (cancer DWLOC = 0.45
ppb). However, potential concentrations in surface water (0.57 ppb for 2" incorporation and 1.26 ppb
for no incorporation) result in exposure that exceeds the Agency's level of concern for the U.S.
population (0.45 ppb). It is important to note that triallate products are typically immediately
incorporated into the soil to minimize loss by volatilization, especially for products formulated as ECs,
which require incorporation.
As discussed above, there were no surface water monitoring data for TCPSA to assess runoff potential
from actual triallate use. To address the uncertainties of the fate properties of TCPSA, and total parent
and metabolite concentrations in drinking water, the registrant initiated a three year surface drinking
water monitoring study in June 1999 to measure triallate and TCPSA concentrations. The study is
designed to measure raw and finished triallate and TCPSA residue levels at five surface drinking water
collection locations. The locations where measurements are to be taken were selected based on a
variety of factors, including high triallate use; small watersheds with a high percentage of land planted to
wheat; higher rainfall; and vulnerable soil conditions. Interim results of the surface water monitoring
data were provided to the Agency on February 16 and May 22, 2000. The preliminary results indicate
that the higher concentrations of triallate and TCPSA appear during the spring runoff, and especially in
smaller watersheds with higher rainfall. Furthermore, the results to date indicate that all raw and
finished measurements of peak and mean exposure to total parent triallate and TCPSA at all five sites
are below the cancer DWLOC (0.45 ppb). Additional monitoring data will be provided on a quarterly
basis, with a final report of the study expected in late 2002.
3. Aggregate Risk
Aggregate risk looks at the combined risk from dietary exposure through both food and drinking water,
as well as from exposures from non-occupational sources (e.g., residential uses). Generally, all risks
from these exposures must be less than 100% of the acute PAD and chronic PAD (both non-cancer
and cancer). For triallate, the aggregate risks are limited to dietary (food and water) exposure,
because there are no residential uses.
16
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Acute Dietary
Considering both the acute dietary (food) risk estimates and the surface and ground water estimated
concentrations (drinking water) for triallate, the exposure is less than 100% of the acute PAD, and
therefore, is not of concern.
Chronic (Non-Cancer) Dietary
Considering both the chronic (non-cancer) dietary (food) risk estimates and the surface and ground
water estimated concentrations (drinking water) for triallate, the exposure is less than 100% of the
chronic PAD, and therefore, is not of concern.
Chronic (Cancer) Dietary
The Agency generally considers 1 x 10"6 (1 in 1 million) or less as negligible risk for cancer. The results
of this analysis indicate that the cancer dietary (food) risk estimate of 7.1 x 10"8 associated with the uses
supported through reregistration and the proposed use on sugar beets is not of concern. The cancer
DWLOC is 0.45 ppb. The Tier H (PRZM-EXAMS) estimated average concentration of triallate +
TCPSA in surface water is 0.566 ppb (mean annual with 2" incorporation) and 1.26 ppb (mean annual
with no incorporation). Concentrations in ground water are not expected to be higher than 0.21 ppb.
The 36-year annual mean estimated concentrations in surface water exceed the DWLOCs for triallate
+ TCPSA in drinking water as a contribution to cancer aggregate exposure. However, the drinking
water component is based on model predictions, which are generally conservative in estimating
chemical concentrations in drinking water. To address this concern, the registrant initiated a three-year
surface drinking water monitoring study in June 1999 to measure raw and finished triallate + TCPSA
concentrations at five surface drinking water collection locations. Interim results of the surface water
monitoring study indicated that peak and mean exposure to total parent triallate and TCPSA at all five
sites are below the cancer DWLOC (0.45 ppb). Additional monitoring data will be provided on a
quarterly basis, with a final report of the study expected in late 2002.
4. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational handlers of triallate include individual farmers or
growers and professional applicators who mix, load, and/or apply pesticides. Dermal and inhalation
risk for all of these 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) from an animal study. For triallate, MOEs greater than 100 are not of concern. The
Agency also conducted an assessment of the cancer risk associated with triallate following exposures to
occupational handlers. Cancer risks to workers of 1 x 10"6 (1 in 1 million) and less are considered to
be negligible. For more information on the assumptions and calculations of potential risks to workers,
see the Occupational Exposure section of the April 18, 2000 Human Health Risk Assessment.
17
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a. Occupational Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is
complete. Triallate has a low order of acute toxicity via dermal and inhalation routes, and produces
slight irritation to the eyes and skin. Although triallate was not a skin sensitizer in the Buehler dermal
sensitization assay, but was shown to be a sensitizer in the guinea pig maximization sensitization test, the
Agency considers both test methods to be acceptable for assessing the potential to cause or elicit skin
sensitization reactions. Because a positive response is observed in one of the sensitization tests, triallate
is determined to be a skin sensitizer. The following is the acute toxicity profile for occupational
exposure:
Table 7: Acute Toxicity Profile
Route of Exposure
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
MRIDNo.
42192001
00121856
44591801
44581601
44308301
Results
LD50 > 5000 mg/kg
LC50 > 5.3 mg/L
Slight eye irritant
Slight dermal irritant
Dermal Sensitizer
Toxicity Category
IV
IV
III
IV
NA
For more occupational toxicity information used to assess risks to workers, see the Hazard
Characterization section of the April 18, 2000 Human Health Risk Assessment.
Dermal Endpoint
For the short- and intermediate-term dermal endpoint, an oral NOAEL of 5 mg/kg/day was selected
based on increased skeletal malformations/variations in the rabbit developmental toxicity study at the
LOAEL of 15 mg/kg/day. A 21-day dermal toxicity study in rats with a systemic toxicity NOAEL of
500 mg/kg/day and a LOAEL of 3000 mg/kg/day is available. However, the Agency selected the
developmental NOAEL from an oral study based on the following factors: 1) skeletal malformations
were seen following in utero exposure in two species, rats and rabbits; 2) concern for the differences in
the endpoints seen following oral administration in the developmental toxicity study (skeletal
malformations) and dermal administration in the 21-day dermal toxicity study (body weight loss) in the
same species (rats); 3) developmental effects were not evaluated in the dermal toxicity study (i.e., the
consequence of these effects can not be ascertained for the dermal route of exposure); and 4) concern
for exposure to pregnant workers.
A dermal absorption factor of 1% was estimated based on the results of the oral developmental toxicity
study (LOAEL= 30 mg/kg/day) in rats, and a 21-day dermal toxicity study (LOAEL= 3000
mg/kg/day) in rats. While it is not appropriate to use the 21-day dermal study as a critical study for the
risk assessment (see above), it is appropriate for use to extrapolate a dermal absorption factor, because
18
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the oral and dermal studies in the same species (rat) demonstrated the same toxic effect (decreases in
body weight gain), thus indicating dermal absorption.
Inhalation Endpoint
For the short- and intermediate-term inhalation endpoint, an oral NOAEL of 5 mg/kg/day was selected
based on increased skeletal malformations/variations in the same rabbit developmental toxicity study
that was selected for the dermal endpoint. A 7-week subchronic inhalation toxicity study in rats was
conducted, but is not appropriate for regulatory purposes because the study is classified as
supplementary due to technical difficulties (the animals may not have been uniformly exposed to the test
material).
Cancer Endpoint
Triallate is classified as a Group C chemical (possible human carcinogen), based on hepatocellular
carcinomas in male mice, with a positive trend and borderline significance in female mice, and increased
incidence of renal tubular cell adenomas in rats. A linear low-dose (Qi*) approach was used to
characterize human health risk. The unit risk, Qj* based on the hepatocellular carcinomas in male mice,
is 7.17 x 10"2 (mg/kg/day)"1 in human equivalents.
An overview of the toxicity studies used for the occupational risk assessment is outlined in Table 8. For
more occupational toxicity information used to assess risks to workers, see the Hazard
Characterization section of the April 18, 2000 Human Health Risk Assessment.
Table 8. Summary of Triallate Occupational Toxicity Endpoints
Exposure
Scenario
Short- and
Intermediate-Term
(Dermal)
Short- and
Intermediate-Term
(Inhalation)
Long-Term
(Dermal and
Inhalation)
Chronic
(cancer)
Dietary
Dose
(mg/kg/day)
OralNOAEL=5
Oral NOAEL=5
Absorption
Factor*
1%
100%
Endpoint
Increased skeletal
malformations/variations .
Increased skeletal
malformations/variations .
Study
(MRID No.)
Developmental-
Rabbit
(43315001)
Developmental-
Rabbit
(43315001)
A dose and endpoint was not selected because of the current use pattern (maximum
application rate of 1 .5 Ib ai/A per year), and limited handler and re-entry worker activities.
Since long-term dermal and inhalation exposure (continuous exposure of greater than 180
days) is not anticipated, this risk assessment is not required.
Group C - "Possible human carcinogen" - Qj* = 7.17 x 10~2 (mg/kg/day)"1 in human
equivalents [converted from animals to humans by use of the (mg/kg body weight)37' cross
species scaling factor.
* Since an oral NOAEL was selected, a dermal absorption factor of 1% and an inhalation absorption factor of 100%
(default value) are used.
19
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b. Occupational Exposure
Chemical-specific exposure data were not available for triallate, so risks to pesticide handlers were
assessed using data from the Pesticide Handlers Exposure Database (PHED) Version 1.1, and
standard assumptions about average body weight, work day, daily areas treated, volume of pesticide
used, etc. The exposure factors (e.g., body weight, amount treated per day, protection factors, etc.)
are all standard values used by the Agency, and the PHED unit exposure values are the best available
estimates of exposure.
Anticipated use patterns, application methods, and range of application rates were derived from current
labeling. The daily amount treated is based on standard assumptions. Triallate can be applied with a
groundboom, tractor-drawn spreader, or a fixed-wing aircraft, and at a rate of 1.0 to 1.5 pounds active
ingredient/acre (ai/A) for liquid formulations, and 1.25 to 1.5 pounds ai/A for granules.
Occupational handler exposure assessments are conducted by the Agency using different levels of
personal protection. The Agency typically evaluates all exposures with minimal protection and then
adds additional protective measures using a tiered approach (going from minimal to maximum levels of
protection) to obtain an appropriate MOE. The lowest tier is represented by the baseline exposure
scenario (i.e., single layer clothing, socks, and shoes), followed by, if required (MOEs are less than
100), increasing levels of risk mitigation [i.e., personal protective equipment (PPE) and engineering
controls (EC)]. The current labels for triallate require handlers to wear long-sleeved shirt and long
pants, shoes plus socks, chemical-resistant gloves, and protective eyewear for liquid end-use products;
and long-sleeved shirt and long pants, and shoes plus socks for granular end-use products. The levels
of protection that formed the basis for calculations of triallate exposure from handler activities are
outlined in Table 10.
Based on the handlers activity pattern, the duration of exposure is only short-term (1-7 days) and
intermediate-term (1 week to 6 months) for occupational handlers (this is based on the fact that there
are different planting periods for the registered crops for triallate). Based on the current use pattern
(maximum application rate of 1.5 Ib ai/A per year) and handler activities, long-term (chronic) exposure
is not anticipated nor expected; therefore, a long-term (chronic) exposure risk assessment is not
required.
Handler Exposure
There are potential occupational exposures to pesticide handlers and to other workers when applying
triallate. Occupational handlers and workers are potentially exposed via dermal and inhalation routes.
The occupational dermal and inhalation risk estimates for triallate handler scenarios
(mixers/loaders/applicators) are not of concern with use of minimum personal protective equipment
(PPE) (single layer clothing with gloves) for mixers/loaders of liquid products; baseline protection
(single layer clothing) for loaders of granular products, applicators using ground equipment, and
flaggers; and engineering controls (enclosed cockpits) for aerial applicators.
20
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The inhalation risk expected from triallate exposure is minimal, because of the low acute toxicity (LC50
> 5.3 mg/L, Toxicity Category IV), moderate vapor pressure (1.1 x 10"4 mm Hg at 25 °C for the
technical grade), and low unit exposure values estimated by daily inhalation doses with baseline levels of
personal protection. However, occupational inhalation daily dose values were still calculated and
presented for this risk assessment.
EPA conducted an assessment of the cancer risk associated with triallate following exposures to
occupational handlers. The cancer risks, for the handler (dermal plus inhalation) exposures, are based
on the assumption that a private farmer applies triallate products 15 days a year and a commercial
applicator applies triallate products 30 days a year. The calculated cancer risks for all scenarios at
baseline protection (i.e., single-layer clothing) and with personal protective equipment (PPE) (i.e.,
single-layer clothing with gloves for mixers/loaders, and double-layer clothing for ground applicators)
are greater than 1 x 10"6. With the addition of engineering controls (i.e., closed mixing/loading systems,
enclosed cabs and cockpits), over half of the scenarios are either near or below 1 x 10"6.
Mixer/Loader/Applicator Risk
A description of the occupational mixer/loader/applicator scenarios and resulting risks are summarized
in Tables 9 and 10. For more information on the occupational risks, see the Risk Calculations,
Occupational Exposure section of the April 18, 2000 Human Health Risk Assessment.
Table 9. Mixer/Loader/Applicator Scenario Summary
Scenario
No.
l(a)
l(b)
2(a)
2(b)
3(a)
3(b)
4(a)
4(b)
5
6
Description
Mixer/Loader
Mixer/Loader
Mixer/Loader
Mixer/Loader
Applicator
Applicator
Applicator
Applicator
Flagger
Flagger
Product Form
Liquid
Liquid
Granules
Granules
Liquid
Liquid
Granules
Granules
Liquid
Granules
Application Method
Groundboom
Aerial
Aerial
Tractor Drawn/Mechanical Spreader
Groundboom
Aerial
Tractor Drawn Spreader
Aerial
Aerial
Aerial
Rate
(Ibs ai/A)
1.3
Acres Treated
80
350
350
80
80
350
80
350
350
350
21
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Table 10. Mixer/Loader/Applicator Risk Summary
Scenario
No.
l(a)
l(b)
2(a)
2(b)
3(a)
3(b)
4(a)
4(b)
5
6
Baseline
SLCC
SLCC
PPE
SLCC with
glovesd
SLCC with
coveralls
See Engineering Controls
SLCC
SLCC with
coveralls
See Engineering Controls
SLCC
NR
Engineering
Controls
Closed mixing
and loading
Closed cab
tractor
Enclosed
cockpit
Closed cab
tractor
Enclosed
cockpit
Enclosed
cab
Dermal MOEsa
Baseline
86
20
6800
29000
18000
PPE
11000
2500
NR
NA
25000
EngC
NR
11000
NR
NA
5000
19000
33000
NR
Inhalation MOEsa
Baseline
2100
480
340
1500
3400
PPE
NR
NA
2100
EngC
NR
8300
NR
NA
1700
3800
450
NR
Cancer Riskb
Baseline
1.5E-4
6.7E-4
3.9E-5
9.0E-6
4.5E-6
PPE
7.2E-6
3.8E-5
3.8E-5
8.8E-6
4.3E-6
NA
6.6E-6
6.3E-6
NA
l.OE-5
4.0E-6
XT A
EngC
8.5E-7
3.7E-6
7.9E-7
1.8E-7
4.7E-7
2.6E-6
1.2E-6
7.6E-7
7.8E-6
3.3E-6
a Dermal and Inhalation MOEs represents both short and intermediate-term exposure because the NOAELs are the same. Target MOE* 100.
b Cancer risk figures represent exposure to commercial applicators (30 days exposure/year). Risk to private applicators are half of commercial applicators.
0 SLC (Single Layer Clothing): includes long sleeve shirt, long pants, shoes and socks for dermal exposure; no respirator for inhalation exposure; and open
cab tractor for ground applicators.
d Gloves: 90% protection factor for chemical-resistant gloves.
NR: Not required, since less protective measures have MOEs>100.
NA: Data either not available (aerial applicators) or no measurable effect (flaggers).
Liquid end-use product labels require long-sleeved shirt and long pants; shoes plus socks; chemical-resistant gloves; and protective eyewear.
Granular end-use product labels require long-sleeved shirt and long pants; shoes plus socks.
22
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Harvester Exposure and Risk
Finally, exposure to workers through entry into agricultural fields treated with triallate was also
considered. For workers entering a treated site, restricted entry intervals (REIs) are generally
calculated to determine the minimum length of time required before workers or others are allowed to
enter after treatment. However, for triallate, the Agency believes that the potential for post-application
worker exposure is low, provided the currently required 12 hour REI is observed. The low potential
for exposure is due to the timing of applications. Triallate is applied to the soil and/or soil incorporated
pre-emergence for wheat, barley, peas, and lentils. This is well before the plants are mature, which
likely mitigates the potential for post-application exposure due to contact with treated foliage.
Significant exposure to triallate during harvesting, or any other late season activity, is not likely since
triallate is applied pre-emergent. Therefore, a post-application exposure assessment is not required.
Incident Reports
Based on reports from the OPP Incident Data System, Poison Control Centers, California Department
of Pesticide Regulation, and the National Pesticide Telecommunications Network, there were relatively
few incidents of illness due to triallate exposure. Of the incidents where exposure was reported, the
medical outcome was either minor or no symptoms had developed. Moreover, on the list of the top
200 chemicals for which the National Pesticide Telecommunications Network received calls from
1984-1991, triallate was not reported to be involved in human incidents.
B. Environmental Risk Assessment
A summary of the Agency's environmental fate and effects risk assessment is presented below. More
detailed information on the environmental and ecological risks associated with the use of triallate may be
found in the Reregistration Eligibility Document for Triallate Environmental Fate and Effects
Chapter, September 30, 1999. The complete environmental fate and effects risk assessment is not
included in this document, but is available on the Agency's web page at www.epa.gov/pesticides, and in
the Public Docket.
1. Fate and Transport
Triallate is stable to chemical degradation processes including hydrolysis, aqueous photolysis, and
photolysis on soil. The presence of environmental photosensitizers could contribute to triallate
photodegradation in natural waters. The major route of triallate degradation is aerobic soil metabolism,
with a large percentage of the chemical completely degrading to carbon dioxide (t1/2 = 18-98 days). In
a recently submitted study, triallate degraded aerobically with calculated half lives of 37 days in clay
loam at 20°C; 57 to 60 days in a sandy loam at 20°C; 58 days in silly clay loam at 20°C; and 98 days
in sandy loam 1 at 10°C. The rate of metabolism of triallate in sandy loam soil was influenced by the
temperature of the test system. Triallate metabolizes much more slowly under anaerobic conditions;
21% of the applied radioactivity was recovered as parent triallate after 30 days aerobic and 60 days
anaerobic incubation.
23
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Open literature data indicate that triallate volatilization is a route of dissipation under actual use
conditions. In a USGS review, triallate volatilization accounted for 15% of applied triallate for
incorporated triallate, and 74% of applied triallate for unincorporated triallate. In another study, 21%
of applied triallate volatilized over a 24-day period after application of granular triallate.
The batch equilibrium data indicate that triallate is not expected to be mobile. Soil column leaching
studies appear to confirm triallate's lack of mobility in soil. In an aged column leaching study, 7% of the
applied radioactivity was found in the leachate. In a recently submitted study, 17.5 % of the applied
C14-activity in the leachate was identified as the metabolite TCPSA. Triallate volatilized with a flux of
3.6 x 10"3 jig/cnf/hr from sand treated at a rate of 1.5 Ib ai/acre. Under these conditions, half of the
applied triallate would dissipate as vapor in 30 days. Virtually all of the volatilized material was parent.
Because of triallate volatility under typical use conditions, particularly with the liquid (EC) formulations,
the label instructions indicate that triallate must be incorporated into the soil immediately after spraying.
Field dissipation studies with a granular formulation suggest that triallate dissipated with half-lives of 20-
190 days in six U.S. locations (ID 60 days, SD 20 days, MT 30 days, ND 50 days, KS 85 days, and
WA 190 days).
Triallate accumulated in fish with bioconcentration factors (BCFs) of 700x in edible fish tissues, 2700x
in viscera, and 1600x in whole fish. However, depuration was >90% within 14 days after ending
exposure; therefore, triallate is unlikely to significantly bioconcentrate up the food chain.
Limited environmental fate data for the metabolite TCPSA is available. The submitted fate data for
TCPSA were derived from structural activity relationships and from a limited number of preliminary
laboratory studies. The available data indicate that the metabolite TCPSA is more mobile than the
parent triallate (Koc=35 ml/g) and is moderately persistent in soil (t1/2 = 66 days).
For more environmental fate and transport information on triallate, see the Environmental Fate
Assessment section of the September 30, 1999 Environmental Fate and Effects Risk Assessment.
2. Water Resources
Because water monitoring data for the TCPSA metabolite are not available, the Agency has relied on
computer simulation models to assess risks to aquatic organisms. The Agency used the Tier n
PRZM/EXAMS model to estimate triallate concentrations in surface water bodies. These estimated
environmental concentrations (EECs) are used to calculate exposure and risk to aquatic organisms.
The surface water model EECs were conducted for parent triallate only, because limited environmental
fate and toxicity data are available on the metabolite TCPSA. Also, the PRZM/EXAMS estimates for
potential exposure to aquatic organisms do not include the Index Reservoir (IR) and Percent Crop
Area (PC A) refinements that are part of the human drinking water assessment. The IR was developed
from a real watershed in western Illinois to be used as a standard watershed to estimate surface
24
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drinking water concentrations, and is not appropriate for use to estimate pesticide concentrations in
water bodies available to aquatic organisms. Since triallate is used mainly on small grains (spring wheat
and winter wheat), it is expected that triallate use on these grains is the highest source contribution of
triallate loading into surface and ground waters. Therefore, winter wheat and spring wheat scenarios
were used as the scenarios for aquatic exposure assessments. Depending upon the application rate and
whether or not the pesticide was incorporated, the Tier n model predicted peak (acute) concentrations
that ranged from 2.01 ppb to 5.50 ppb, and the 60-day average (chronic) concentrations ranged from
0.72 ppb to 2.49 ppb.
For more information on estimated triallate concentrations in surface water to assess risks to aquatic
organisms, see the Water Resource Assessment and Risk to Nontarget Freshwater or Estuarine
Aquatic Organisms of the September 30, 1999 Environmental Fate and Effects Risk Assessment.
Also, see the Dietary Risk from Drinking Water section of this RED for a discussion of human
drinking water concentrations and risk.
3. Ecological Risks
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity studies
using the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by
ecotoxicity values, both acute and chronic, for various species. The higher the RQ, the greater the
concern. Risk characterization provides further information on the likelihood of adverse effects
occurring by considering the fate of the chemical in the environment, communities and species
potentially at risk, their spatial and temporal distributions, and the nature of the effects observed in
studies. For more information on the ecological risks posed by the use of triallate, see the Ecological
Effects Hazard Assessment and Ecological Risk Assessment sections of the September 30, 1999
Environmental Fate and Effects Risk Assessment.
Overall, the ecological risks from triallate use are low. The use of triallate is not likely to pose
significant risk to birds, fish, large mammals, reptiles or nontarget insects. Levels of concern (LOCs)
are slightly exceeded for endangered small mammals (RQs < 0.15); however, this risk is dependent on
ingestion of high amounts of contaminated insects or seed in the diet. Because triallate products are
typically immediately incorporated into the soil following application, this potential risk may be reduced.
The likelihood of acute high risk to invertebrates is not predicted from runoff from incorporated or
unincorporated uses of triallate. However, based on Tier n water modeling results from wheat use with
delayed or no incorporation, LOCs are slightly exceeded for acute risk to endangered aquatic
invertebrates (RQs • 0.16). However, the only endangered aquatic invertebrate in the counties where
triallate is registered and potentially used is the Higgins eye pearly mussel which occurs in large rivers
such as the Mississippi. This habitat is not likely to receive high exposure modeled concentrations of
triallate due to the dilution factors associated with large river systems; therefore, triallate is not expected
to have an effect on endangered aquatic invertebrates.
25
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Nevertheless, there are a number of uncertainties which may increase the risk factors to aquatic
organisms. First, the major use areas of triallate include many areas which have wetland and pothole
habitats. For example, 7% of the total land area of the Red River Basin is covered by wetlands.
Modeled water residues are for deeper water bodies; thus, shallow water contamination of potholes,
marshes or other similar aquatic habitats might more closely approach chronic toxicity thresholds.
Prairie potholes also often serve as important feeding areas for overwintering or migrating waterfowl
which benefit from high temporal populations of aquatic invertebrates. Small grain and edible bean
crops commonly surround small prairie pothole areas.
Triallate exceeds acute risk, restricted use, and endangered species levels of concern for terrestrial
(RQs = 1.0 to 1.5) and semiaquatic plants (RQs = 5 to 15). Acute risk to aquatic plants will be
assessed upon receipt of aquatic plant studies as required under Guideline 123-2.
No ecological incidents have been reported from triallate use.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether or not products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient-specific) data required to support reregistration of products containing triallate as an
active ingredient. The Agency has completed its review of these generic data, and has determined that
the data are sufficient to support reregistration of all products containing triallate. Appendix B identifies
the generic data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of triallate.
These data were sufficient to allow the Agency to determine that triallate can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency, therefore, finds that all
products containing triallate as the active ingredient are eligible for reregistration, provided specified
changes are made to the label. Actions needed to reregister particular products are addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based on the data required for reregistration,
the current guidelines for conducting acceptable studies to generate such data, and published scientific
literature. The Agency has found that all currently registered uses of triallate, except canary grass, are
eligible for reregistration, provided specified changes are made to the label. Canary grass is not being
supported by the registrant for reregistration and tolerances have been revoked. However, the Agency
may take appropriate regulatory action if new information comes to the Agency's attention regarding the
26
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reregistation of triallate. The Agency may also require the submission of additional data (1) to support
the registration of products containing triallate, (2) if the data requirements for registration change, or
(3) if the guidelines for generating such data change.
It is important to note that the decision that all currently registered uses of triallate, except for canary
grass, are eligible for reregi station, provided specified changes are made to the label, does not include
the petition to establish tolerances for triallate use on sugar beets. As stated earlier, the decision on
whether or not to grant tolerances for sugar beet use will be made separately from this RED.
B. Regulatory Position
1. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for triallate, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general population.
In reaching this determination, EPA has considered all available information on the toxicity, use
practices and scenarios, and the environmental behavior of triallate. Since there are no residential or
lawn uses of triallate, no dermal or inhalation exposure is expected in and around the home. Therefore,
EPA has considered only acute, chronic (non-cancer), and chronic (cancer) exposures from dietary
(food and drinking water) sources in its aggregate risk assessment.
In assessing acute aggregate dietary risk, the Agency has used a NOAEL of 60 mg/kg/day in an acute
neurotoxicity study in rats for the U.S. general population, and a NOAEL of 5 mg/kg/day from a
developmental toxicity in rabbits for the females (13-50 years) population subgroup. A highly refined
(Tier 3) probabilistic (Monte Carlo) analysis, for acute dietary exposure to the residues of triallate on
registered crops and proposed use on sugar beets, was performed by the Agency. For all dietary
analyses, anticipated residues and percent crop treated information were used. The results of this
analysis indicate that the acute dietary (food) exposure for the U.S. population and all population
subgroups at the 99.9th percentile are significantly below the Agency's level of concern (<2% aPAD)
(see Table 3). To determine the contribution of drinking water to acute dietary exposure, an acute
DWLOC was calculated to be 21,000 ppb for the U.S. general population. The surface and ground
water estimated environmental concentrations (9.45 ppb and 0.21 ppb, respectively) are significantly
below the acute DWLOC (see Table 6); therefore, acute dietary exposure from both food and water
are below the Agency's level of concern.
The Agency also conducted a Tier 3 analysis for chronic (non-cancer) dietary (food) exposure to
triallate on registered crops and the proposed use on sugar beets. A NOAEL of 2.5 mg/kg/day was
established from a 2-year chronic toxicity/carcinogenicity study in rats. Based on the results of this
analysis, the chronic dietary (food) risk estimates associated with triallate use patterns are significantly
below the level of concern for the U.S. population and all relevant subgroups (<1% cPAD) (see Table
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4). The DWLOC calculated to assess the drinking water contribution to chronic dietary exposure is
875 ppb for the U.S. general population. The surface and ground water estimated environmental
concentrations (1.26 ppb and 0.21 ppb, respectively) are significantly below the chronic DWLOC (see
Table 6); therefore, chronic (non-cancer) dietary exposure from both food and water are below the
Agency's level of concern.
For cancer dietary risk assessment, the Agency has estimated the cancer dietary (food) risk to be 7.1 x
10"8 for uses supported through reregistration and the proposed use of triallate on sugar beets (see
Table 5). Because the Agency generally considers 1 x 10"6 or less to be negligible for dietary cancer
risk, the risk of cancer from dietary exposure to triallate is below the Agency's level of concern. The
DWLOC calculated to assess the drinking water contribution to cancer dietary exposure is 0.45 ppb.
While ground water estimated environmental concentrations (0.21 ppb) are below the cancer
DWLOC, the total triallate residue concentrations in surface water following spring application to wheat
(1.26 ppb for non-incorporation) exceed the cancer DWLOC (see Table 6). Given the generally
conservative nature of the drinking water screening models; indications from available monitoring data
for parent triallate that suggest that the risk of drinking water exposure is less than that predicted by
model simulations; and the initiation of a surface water monitoring program by the registrant to measure
actual concentrations of triallate and its metabolite TCPSA from vulnerable drinking water sources, no
additional mitigation measures are deemed necessary at this time to protect the U.S. general population.
2. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for triallate, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children.
The safety determination for infants and children considers the factors noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the specific
consumption patterns of infants and children, as well as the possibility of increased susceptibility to the
toxic effects of triallate residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects from
triallate residues, EPA considered the completeness of the database for developmental and
reproductive effects, the nature of the effects observed, and other information. For triallate, the FQPA
safety factor of 10 was reduced to 3. The FQPA safety factor of 3 is only applicable to the females
(13-50 years) population subgroup, because the effects of concern (observed in the prenatal
developmental toxicity study in rabbits) occur in utero and not during post-natal exposure. Moreover,
the FQPA safety factor for triallate is only applicable to the acute dietary risk assessment, since the
effects of concern were observed only during in utero exposure. The FQPA safety factor does not
apply to occupational exposure, and no registered residential uses exist at this time.
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EPA estimates that for registered uses of triallate and its proposed use on sugar beets, the residues of
triallate in the diets of infants and children account for less than 1% of both the acute and chronic (non-
cancer) PAD (see Table 3 and 4). Additionally, the residues in drinking water are significantly below
the acute DWLOC (6000 ppb) and chronic DWLOC (250 ppb) for the children (1-6 years)
population subgroup (see Table 6). The Agency, therefore, concludes that acute and chronic (non-
cancer) aggregate risks for infants and children resulting from triallate uses are not of concern.
3. 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 recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP have been
developed, triallate may be subject to additional screening and/or testing to better characterize effects
related to endocrine disruption.
4. Cumulative Risks
The Food Quality Protection Act requires that, when considering whether to establish, modify, or
revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity." The
Agency is examining whether and to what extent some or all organophosphorous and carbamate
(including, but not limited to, methyl carbamate, N-methyl carbamate, thiocarbamate, and
dithiocarbamate) pesticides may share acetylcholinesterase inhibition as a common mechanism of
toxicity. In contrast to the methyl and N-methyl carbamates, the Agency has a less fully developed
understanding of whether or not the thiocarbamates share acetylcholinesterase inhibition as a common
mechanism of toxicity with other cholinesterase-inhibiting chemicals. While current data are limited, the
thiocarbamates appear to be comparatively weak cholinesterase inhibitors and are generally regulated
based on other toxic endpoints. As a result, the Agency has not determined if it would be appropriate
to include them in a cumulative risk assessment with other such chemicals (e.g., the organophosphorous
and carbamate pesticides) [see the August 31, 1999, EPA Memorandum entitled September 1999
29
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Meeting of the FIFRA Science Advisory Panel: Working Documents for the Session: "Proposed
Guidance for Conducing Cumulative Hazard Assessments for Pesticides that Have a Common
Mechanism of Toxicity" and "The Carbamate Pesticides and the Grouping of Carbamate with the
Organophosphorous Pesticides"].
In September 1999, the Agency presented a paper (cited above) on the common mechanism of toxicity
of the carbamate pesticides to the Science Advisory Panel (SAP). In that presentation, the Agency
noted that although various classes of compounds may inhibit acetylcholinesterase, the potency,
reversibility, and related factors may influence whether or not related pesticides should be included in a
cumulative risk assessment.
Similarly, the Agency is examining whether and to what extent some or all pesticides that may be human
carcinogens may also share a common mechanism of toxicity. Current information on the common
mechanism of toxicity for possible or probable human carcinogens is limited, and the Agency's
understanding of this relationship needs to be further developed. As a result, the Agency has not
determined if it would be appropriate to include them in a cumulative risk assessment with other human
carcinogen chemicals.
At this time, the Agency does not believe it has sufficient reliable information concerning common
mechanism issues to determine whether or not triallate, a thiocarbamate, shares a common mechanism
of toxicity with other cholinesterase-inhibiting or possible human carcinogen chemicals. Therefore, for
the purposes of this risk assessment, the Agency has assumed that triallate does not share a common
mechanism of toxicity with cholinesterase-inhibiting or human carcinogen chemicals.
C. Tolerance Reassessment Summary
The established tolerances [40 CFR §180.314, (a)] for residues of triallate in/on plant commodities are
currently expressed in terms of triallate per se (parent only). The triallate tolerance expression will be
revised in order to reflect the Agency's determination that triallate and its TCPSA metabolite should be
regulated and assessed for dietary exposure in plant commodities. The Agency decided to regulate on
the TCPSA metabolite because it is present at more than 10% of the total radioactive residue (TRR) in
the plant metabolism studies. Tolerances are to be expressed as triallate for the combined residues of
the herbicide triallate (S-2,3,3-trichloroallyl diisopropylthiocarbamate) and its metabolite TCPSA
(2,3,3-trichloroprop-2-ene sulfonic acid) in or on the following commodities: barley, peas, and wheat.
No tolerances have been established for animal or processed food/feed commodities. A total of nine
tolerances will be reassessed as part of this RED.
The Agency has updated the list of raw agricultural and processed commodities and feedstuffs derived
from crops (Table 1, OPPTS GLN 860.1000). As a result of changes to Table 1 (OPPTS GLN
860.1000), triallate tolerances for certain commodities which have been removed from Table 1
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(OPPTS GLN 860.1000) need to be revoked, and some commodity definitions must be corrected. A
summary of triallate tolerance reassessments is presented in Table 11.
Tolerances Listed Under 40 CFR §180.314 (a)
All tolerances listed under 40 CFR §180.314 (a) will be moved to §180.314 (c) with the revised
tolerance expression to specify regional registration of triallate, and §180.314 (a) General will be
reserved. Uses of the registered granular (G) and emulsifiable concentrate (EC) formulations of
triallate, when applied according to label directions, are permitted only in the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT, WA, and WY.
Sufficient data have been submitted to reassess the established tolerances for the following plant
commodities, as defined: barley, grain; barley, straw; peas; peas, forage; peas, hay; wheat, grain; and
wheat, straw. The available data from field trials reflecting the maximum registered use patterns suggest
that the combined residues of triallate and its TCPSA metabolite will exceed the currently established
tolerance level of 0.05 ppm for most of the above commodities.
The established tolerances for the following commodities, as defined, will be revoked: lentils; and
lentils, hay. Lentils are classified as peas in accordance with 40 CFR §180.l(h), and adequate data are
available for peas.
New Tolerances to be Established Under 40 CFR §180.314 (c)
As a result of changes in Table 1 (OPPTS GLN 860.1000), field residue data and tolerances are
required for barley hay, wheat forage, and wheat hay. The required data for wheat hay may be
translated to barley hay, because the registered uses of triallate on barley and wheat are identical.
Adequate data are available for wheat forage to initiate establishment of a tolerance, and these data are
the basis for tolerance establishment.
The available wheat processing data indicate that the combined residues of triallate and TCPSA did not
concentrate in flour but concentrated in bran (2.5x) and shorts (2.0x). These fractions were processed
from whole wheat grain bearing nondetectable residues of triallate (<0.01 ppm) and detectable residues
of TCPSA (0.03 ppm) following treatment at 1.7x the maximum registered rate. The highest average
field trial (HAFT) (combined residues) of wheat grain from trials reflecting Ix treatment is <0.02 ppm.
Based on this FLAFT and the observed concentration factors, the maximum expected combined
residues are <0.05 ppm for bran (2.5 x <0.02) and <0.04 ppm for shorts (2.0 x <0.02 ppm). These
maximum expected residues are equal or less than the reassessed tolerance of 0.05 ppm for wheat
grain. Therefore, tolerances for the combined residues of triallate and TCPSA in wheat bran and shorts
are not needed.
The reregistration requirements for limited/extensive field rotational crop studies have not been fulfilled.
Depending on the outcome of these required studies, rotational crop tolerances may be required.
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The expected dietary burdens of triallate to beef/dairy cattle and poultry animals were recalculated
following tolerance reassessment of livestock feed items. There is no reasonable expectation of finite
residues (Category 3 of 40 CFR §180.6); therefore, tolerances are not required for milk, eggs, and
animal tissues.
Pending Active Tolerance Petition
PP#8F2128: Monsanto has proposed the establishment of regional tolerances for the combined
residues of triallate and its TCPSA metabolite in/on sugar beet roots at 0.1 ppm, sugar beet foliage at
0.5 ppm, and dried sugar beet pulp at 0.2 ppm. The decision of whether to establish the proposed
tolerances for sugar beets will be made separately from this RED.
Table 11. Tolerance Reassessment Summary for Triallate
Commodity
Established
Tolerance 1
(ppm)
Reassessed
Tolerance 2
(ppm)
Comments
[Correct Commodity Definition]
Tolerance Listed Under 40 CFR §180.314 (c)
Barley, grain
Barley, straw
Lentils
Lentils, hay
Peas
Pea, succulent}
-"eas
Pea, dry]
-"eas, forage
Pea, field, vines]
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05
0.3
Transferred to
Peas
Revoke
0.2
0.2
0.5
The available data, reflecting the maximum registered use
pattern, indicate that residues of triallate and its TCPSA
metabolite were <0.01 ppm each in/on barley grain.
The available data, reflecting the maximum registered use
patterns, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.26 ppm in/on barley
straw. Remove the "(N)" (negligible residues) designation to
conform to Agency practice.
Since a tolerance for peas is established, the tolerance for
lentils should be revoked. According to 40 CFR §180.1(h), the
established tolerance for peas will apply to lentils. Remove the
"(N)" (negligible residues) designation to conform to Agency
practice.
Lentil forage and hay are no longer considered significant
livestock feed items and have been removed from Table 1
(OPPTS GLN 860. 1000). Remove the "(N)" (negligible
residues) designation to conform to Agency practice.
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.12 ppm in/on the
seed and pods of succulent peas and <0.02 ppm in/on the seed
and pods of dried peas. Remove the "(N)" (negligible
residues) designation to conform to Agency practice.
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.39 ppm in/on the
vines of succulent peas and 0.27 ppm in/on the vines of dried
peas. Remove the "(N)" (negligible residues) designation to
conform to Agency practice.
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Commodity
Peas, hay
Pea, field, hay]
Wheat, grain
Wheat, straw
Established
Tolerance 1
(ppm)
0.05 (N)
0.05 (N)
0.05 (N)
Reassessed
Tolerance 2
(ppm)
1.0
0.05
1.0
Comments
[Correct Commodity Definition]
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.73 ppm in/on the
straw of succulent peas and 0.36 ppm in/on the straw of dried
peas. Remove the "(N)" (negligible residues) designation to
conform to Agency practice.
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.04 ppm in/on wheat
grain. Remove the "(N)" (negligible residues) designation to
conform to Agency practice.
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.94 ppm in/on wheat
straw. Remove the "(N)" (negligible residues) designation to
conform to Agency practice.
New Tolerances Needed Under 40 CFR §180.314 (c)
Barley, hay
Wheat, forage
Wheat, hay
--
--
--
TBD3
0.5
TBD3
The requested data for wheat hay will be translated to barley
hay.
The available data, reflecting the maximum registered use
pattern, indicate that the maximum combined residues of
triallate and its TCPSA metabolite were 0.42 ppm in/on wheat
forage.
Additional data are needed.
Tolerances to be Established Under 40 CFR §180.314 (c) Pending Petition
Sugar Beet, root
Sugar Beet, top
Sugar Beet, pulp
—
-
--
0.1
0.5
0.2
Petition PP#8F2128 pending. No additional data are needed.
1 The established tolerance is expressed in terms of triallate per se.
2 The reassessed tolerance is expressed in terms of the combined residues of triallate and its TCPSA metabolite.
3 TBD = To be determined. Establishment of tolerance(s) cannot be made at this time because additional data are
required.
Codex Harmonization
No maximum residue limits for triallate have been established by Codex for any agricultural
commodities. Therefore, there are no issues regarding compatibility with respect to U.S. tolerances.
Residue Analytical Methods
Plants: The current PAM Vol. n method is a GC/ECD method (designated as Method A) which is
used for analysis of residues of triallate per se in/on lentils, peas, and grain and straw of barley and
wheat (Pesticide Reg. Sec. 180.314). PAM Vol. n reports the sensitivity of the method (LOQ) as
0.02 ppm.
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In conjunction with an ongoing petition (PP#8F2128) for the regional registration of triallate on sugar
beets, the registrant has proposed a GC/ECD method (designated as Method RES-099-96, Version
No. 2) for tolerance enforcement purposes. The method determines residues of triallate and its
TCPSA metabolite. Because this method has been subjected to a successful independent laboratory
validation and has also been validated in an Agency study at Beltsville, MD, the Agency concludes that
Monsanto's GC/ECD method (designated as Method RES-099-96, Version No. 2) is adequate for
data gathering and enforcement purposes. This method has recently been submitted and forwarded to
FDA for evaluation and inclusion in PAM Volume n.
Animals: An enforcement method for determination of residues of triallate and its TCPSA metabolite
is not required because tolerances for eggs, milk, and animal tissues have not been established and are
not required for reregistration purposes.
D. Human Health Risk Mitigation
1. Dietary Mitigation
A dietary exposure analysis from food using the Dietary Exposure Evaluation Model (DEEM™) was
completed for a refined Tier 3 approach for acute, chronic (non-cancer), and chronic (cancer) dietary
exposure. The DEEM™ analysis evaluated the individual food consumption as reported by respondents
in the USDA 1989-91 Continuing Surveys for Food Intake by Individuals (CSFII) and accumulated
exposure to the chemical for each commodity. For all analyses, anticipated residues and percent of
crop treated data were used.
The drinking water assessment for triallate was conducted on parent triallate and its metabolite TCPSA.
Although monitoring data from surface and ground water sources are available on parent triallate, none
are available on the metabolite TCPSA. Given the uncertainties in TCPSA fate and transport, and that
pesticides with similar properties (high mobility and moderate persistence) are found in drinking water,
the Agency has based its drinking water assessment on the model estimates.
Acute Dietary (Food)
The percent acute population adjusted doses (PADs) are significantly below the Agency's level of
concern at the 99.9th percentile of exposure for the females 13+ subgroup (<2% aPAD) and for the
general population (<1% aPAD) (see Table 3). Therefore, no mitigation measures are necessary at this
time to address acute dietary risk from food.
Chronic (Non-cancer) Dietary (Food)
Chronic dietary risk from food is also well below the Agency's level of concern. All chronic (non-
cancer) %PADs for all subgroups were less than 1% (see Table 4). Therefore, no mitigation measures
are necessary at this time to address chronic dietary risk from food.
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Cancer Dietary (Food)
The Agency generally considers 1 x 10"6 (1 in 1 million) or less to be negligible risk for cancer. The
results of this analysis indicate that the cancer dietary risk of 7.1 x 10"8, associated with the uses
supported through reregistration of triallate and its proposed use on sugar beets, is below the Agency's
level of concern (see Table 5). Therefore, no mitigation measures are necessary at this time to address
cancer dietary risk from food.
Drinking Water
As explained earlier in this document, model estimates (EECs) of potential drinking water exposure
from ground water sources do not exceed the acute or chronic (non-cancer and cancer) DWLOC
values, and therefore, are below the Agency's level of concern. Similarly, potential drinking water
exposure from surface water sources do not exceed the acute or chronic (non-cancer) DWLOC
values, and also do not pose a concern to the Agency. However, potential exposure from surface
drinking water sources does exceed the Agency's level of concern for chronic (cancer) dietary risk (see
Table 6).
As discussed, the Agency's primary concern with potential contamination of drinking water through
surface run-off is from spring application of triallate to wheat fields that is not incorporated into the soil.
Because no monitoring data of the metabolite TCPSA are currently available, the Agency has relied on
model predictions of both parent triallate and TCPSA to evaluate the level of pesticide concentrations
in drinking water. Based on Tier n PRZM/EXAMS modeling predictions using the Index Reservoir
(IR) and Percent Crop Area (PCA), and at the maximum application rate (1.5 Ibs ai/acre), the surface
water estimated concentrations of cumulative triallate residues slightly exceed the cancer DWLOC (see
Table 6).
Surface Water Monitoring Study
To address this concern, the registrant initiated a surface drinking water monitoring program in June
1999 to measure triallate and TCPSA concentrations. It is a three-year program designed to measure
actual raw and finished triallate and TCPSA residue levels at five select surface drinking water
collection locations. The locations where measurements are to be taken were selected based on a
variety of factors, including high triallate use; small watersheds with a high percentage of land planted to
wheat; higher rainfall; and vulnerable soil conditions. The five sites selected are: Peck, ID; Lewiston,
ID; Cut Bank, MT; Chester, MT; and Mnot, ND. Other sites may be added as more confirmatory
data may be needed or new use sites added.
Interim results of the surface water monitoring data were provided to the Agency on February 16 and
May 22, 2000. The preliminary results indicate that the higher concentrations of triallate and TCPSA
appear during the spring runoff, and especially in smaller watersheds with higher rainfall. However, the
results to date indicate that all raw and finished measurements of peak and mean exposure to total
parent triallate and TCPSA at all five sites are below the cancer DWLOC (0.45 ppb). Additional
monitoring data will be provided on a quarterly basis, with a final report of the study expected in late
2002.
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Tier IIPRZM-EXAMS modeling with the IR and PC A is intended for use as a screening estimate to
evaluate pesticide residue concentrations in surface drinking water sources. That is, the model
estimates are generally expected to be higher than most actual residue values measured in areas where
a particular crop is grown. While surface water modeling estimates for pesticide residues are not
always more conservative than monitoring measurements, it is expected that monitoring data from the
surface water monitoring program already underway will continue to indicate that actual concentrations
of total triallate and TCPSA in surface drinking water sources are below the cancer DWLOC. This
expectation is based, in part, on USGS NAWQA and Canadian monitoring studies, which indicate that
chronic concentrations of triallate (parent only) in filtered surface waters from high use triallate areas are
substantially lower than PRZM-EXAMS predictions.
Although environmental fate data suggest that parent triallate is not expected to move into ground
water, in contrast, TCPSA exhibits fate properties (high mobility and moderate persistence) of
pesticides commonly found in ground and surface waters. Therefore, all triallate product labels should
be amended to incorporate the following advisory:
Ground Water Label Advisory
"Triallate has a degradation product with properties and characteristics associated with chemicals
detected in ground water. The use of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground water contamination."
Surface Water Label Advisory
"Under some conditions, the triallate degradate TCPSA may have a high potential for runoff into
surface water (primarily via dissolution in runoff water). These include poorly draining or wet soils with
readily visible slopes toward adjacent surface waters, frequently flooded areas, areas over-laying
extremely shallow ground water, areas with in-field canals or ditches that drain to surface water, areas
not separated from adjacent surface waters with vegetated filter strips, and areas over-laying tile
drainage systems that drain surface water."
Pending review of the final report of the surface drinking water monitoring study for triallate and
TCPSA, no mitigation measures to address drinking water concerns, beyond the ground and surface
water label advisory, are warranted at this time.
2. Occupational Risk Mitigation
a. Handler Exposure
Dermal and Inhalation
There are potential occupational exposures to pesticide handlers and to workers when applying
triallate. Occupational handlers and workers are potentially exposed via dermal and inhalation routes.
The occupational dermal and inhalation risk estimates for triallate handler scenarios
36
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(mixers/loaders/applicators) are not of concern with use of minimum personal protective equipment
(PPE) (single layer clothing with gloves) for mixers/loaders of liquid products; baseline level of
protection (single layer clothing) for loaders of granular products, applicators using ground equipment,
and Saggers (see Tables 9 and 10). These same levels of protective clothing are currently required on
triallate product labels for the given scenarios.
To calculate occupational exposure, the Pesticide Handler Exposure Database (PHED) was used,
because there is no chemical-specific data which reflects the actual use patterns of triallate. For aerial
applicators, the PHED provides estimated exposures for enclosed fixed-wing aircraft only; therefore,
the calculated dermal and inhalation exposure and risks for aerial applicators are based on engineering
controls (i.e., enclosed cockpits). During a March 20, 2000 conference call with EPA, USD A, the
registrant, and other stakeholders (i.e., growers, commodity groups, land grant universities, and others)
to discuss the basis of the calculated risks of triallate, it was determined that there are very few aerial
applicators of triallate products, and that those that do aerially apply triallate already utilize engineering
controls in the form of enclosed cockpits. Based on this information, the Agency believes that the
impact and burden for aerial applicators to be in enclosed cockpits will be negligible. For these
reasons, the Agency has determined that enclosed cockpits for aerial applicators are necessary on
triallate product labels.
Cancer
By policy, EPA considers non-dietary (including occupational) cancer risks of 1 x 10"6 (1 in 1 million)
and less to be negligible. Based on the Agency's experience, risks typically outweigh benefits for risks
greater than 1 x 10"4. For risks between 1 x 10"4 and 1 x 10"6, the Agency generally examines
occupational risks to determine whether or not the benefits of use outweigh the risks, and will seek
ways to mitigate unacceptable risks. This policy allows for the consideration of a wide range of factors
in making a risk management decision for occupational risks. These factors may include: risk to
individuals, number of people exposed, weight of scientific evidence regarding carcinogenicity, lower
risk alternatives, and benefits associated with the pesticide under review. EPA will seek to reduce the
individual risks to the greatest extent feasible, preferably to 1 x 10"6 or less. The goal is to ensure that
there is a adequate level of protection from exposure to pesticide for workers. Through the
reregistration process and taking benefits into account, additive protective clothing or equipment or
changes in application methods may be necessary.
EPA conducted an assessment of the carcinogenic risk associated with triallate following exposures to
occupational handlers. The calculated cancer risks for all scenarios at baseline protection (i.e., single-
layer clothing) and with personal protective equipment (PPE) (i.e., single-layer clothing with gloves for
mixers/loaders, and double-layer clothing for applicators using ground equipment) are greater than 1 x
10"6. With the addition of engineering controls (i.e., closed mixing/loading systems, enclosed cabs and
cockpits) most scenarios are either near or below 1 x 10"6 (see Tables 9 and 10).
37
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Consistent with EPA's policy to reduce individual cancer risks to the greatest extent feasible, preferably
to 1 x 10"6 or less, the following additional personal protective equipment (PPE) is necessary for
triallate handlers: chemical-resistant gloves for mixers/loaders of liquid end-use products; a dust/mist
filtering respirator for loaders of granular end-use products; and flaggers to be in enclosed truck cabs.
The Agency views these additional protective clothing and equipment as feasible and effective in
reducing cancer risks to triallate handlers. Furthermore, these measures are industry standards for
similar formulations, and in some cases already being utilized by individual growers. Although the
cancer risks with these additional protective measures are still above 1 x 10"6, additional PPE or the
benefits of the use of the pesticide compared with the cost of further protective measures, such as
engineering controls (i.e., closed mixing and loading systems and enclosed tractor cabs), are viewed to
outweigh the limited estimated further risk reductions.
To summarize, the following protective measures are necessary to mitigate risks to handlers and other
workers with triallate end-use products:
Liquid end-use products
Mixers, loaders, applicators*, flaggers*, and other handlers must wear:
• Long-sleeved shirt and long pants
• Shoes plus socks
In addition, mixers, loaders, and equipment cleaners and handlers exposed to the concentrate must
wear chemical-resistant gloves.
Granular end-use products
Loaders, applicators*, flaggers* and other handlers must wear:
• Long-sleeved shirt and long pants
• Shoes plus socks
In addition, loaders must wear:
• A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter. (Note that if
a product contains oil or has instructions that would allow concurrent application with an oil-
containing material, registrants must remove the "N" in the respirator statement.)
* See engineering controls below for additional requirements.
Engineering Controls
• Aerial applicators must be in an enclosed cockpit.
• Flaggers must be in an enclosed cab.
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Since completing the occupational risk assessment for triallate handlers, the Agency revised its policy
on the standard values for the number of acres that can be treated in a single day by various types of
agricultural equipment. When assessing exposure scenarios that include high acre crops, such as wheat,
the standard acres aerially treated has been increased from 350 to 1200 acres per day. The policy also
provides for modification of this value when more detailed information regarding the
geographical/cultural characteristics of the crop is available. Based on various sources, including
information from the registrant, aerially treating 1200 acres of wheat fields with triallate is considered a
high end value. Typically, aerial applicators treat approximately 500 acres of wheat with triallate in a
day, due to wind restrictions. Applicators are generally only able to apply early and/or late in the day
when the wind conditions are acceptable. Even using 1200 acres, the dermal and inhalation MOEs for
handlers, based on the added levels of protection for some scenarios (i.e., gloves for mixers/loaders of
liquid products; dust/mist filtering respirator for loaders of granular products; enclosed cockpits for
aerial applicators; and enclosed truck cabs for flaggers) are still above the target MOE of 100.
Therefore, no additional levels of protection other than those listed above are necessary.
The revised policy also notes that the use of high end acres treated per day values (i.e., 1200 acres per
day for aerial application to wheat and other field crops) may not be appropriate for intermediate-term,
long-term or cancer exposures, depending on the use pattern of the chemical being assessment. When
there are risks of concern for these exposure durations, such as cancer risk concerns for triallate,
chemical specific use information should be obtained. Based on the Agency's understanding of triallate
use practices and additional information from the registrant, for commercial aerial applicators that are
likely to apply to as much as 1200 acres in a day, it is expected that they will apply for approximately 6
to 10 days per year. For aerial applicators that may apply the typical amount of 500 acres per day, it is
estimated that they will apply for approximately 10 to 20 days per year. As noted earlier, the triallate
occupational cancer risk assessment is based on commercial applicators being exposed for 30 days per
year (and private applicators are assumed to be exposed for 15 days per year) and applying to 350
acres per day. This additional use practice information appears to indicate that the total exposure per
year to commercial aerial applicators is comparable for high end and typical acreage applications, and
is consistent with the cancer risk estimates provided in Table 10. Therefore, the triallate occupational
risk assessment accurately assesses cancer risks to aerial applicators of triallate, and no additional
levels of protection other than those listed above are necessary.
b. Post-Application Exposure
For triallate, the Agency believes that the potential for post-application worker exposure is low, given
the currently required 12 hour restricted entry interval (REI). The potential for exposure is low because
of the timing of applications. Triallate is applied to the soil and/or soil incorporated pre-emergence for
wheat, barley, peas, and lentils. This is well before the plants are mature, which likely mitigates the
potential for post-application exposure due to contact with treated foliage. Significant exposure to
triallate during harvesting, or any other late season activity, is not likely since triallate is applied pre-
39
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emergent. Therefore, no further mitigation measures, beyond the current 12 hour REI, to protect
harvesters are necessary.
E. Environmental Risk Mitigation
Overall, the ecological risk from triallate use is low. The use of triallate is not likely to pose significant
risk to birds, fish, large mammals, reptiles or nontarget insects. However, levels of concern (LOCs) are
slightly exceeded for endangered small mammals (RQs < 0.15); however, this risk is dependent on
ingestion of high amounts of contaminated insects or seed in the diet. Because triallate products are
typically incorporated into the soil after application, and is required for the EC formulation products, the
potential risk is expected to be lower. Based on Tier n water modeling results from wheat use, LOCs
are slightly exceeded for acute risk to endangered aquatic invertebrates (RQ < 0.16). However,
because the only endangered aquatic invertebrate in the counties where triallate is registered and
potentially used occurs in large rivers, such as the Mississippi, it is not expected that they will be
exposed to the high modeled concentrations of triallate, due to the dilution factors with a large river
system. Therefore, it is determined that triallate will have no effect on endangered aquatic invertebrates.
Triallate also exceeds acute high risk, restricted use, and endangered species triggers for terrestrial
(RQs < 1.5) and semiaquatic plants (RQs < 15). Acute risk to aquatic plants will be determined upon
receipt of aquatic plant studies as required under Guideline 123-2.
Although risks to plants are greater than the LOG, the overall ecological risk associated with the use of
triallate is low; therefore, no additional mitigation measures to reduce estimated ecological risks are
necessary.
F. Other Labeling
In order to remain eligible for reregistration, other use and safety information need to be placed on the
labeling of all end-use products containing triallate. 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 will eliminate the adverse impacts. At present, the program is being implemented on an
interim basis as described in a Federal Register notice (54 FR 27984-28008, July 3, 1989), and is
providing information to pesticide users to help them protect these species on a voluntary basis. As
currently planned, but subject to changes as the final program is developed, the final program will call
for label modifications referring to required limitations on pesticide uses, typically as depicted in county-
specific bulletins or by other site-specific mechanisms as specified by state partners. A final program,
which may alter from the interim process, will be described in a future Federal Register notice. The
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Agency is not requiring label modifications at this time through the RED. Rather, any requirements for
product use modifications will occur in the future under the Endangered Species Protection Program.
2. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, State Lead
Agencies for pesticide regulation, and other parties to develop the best spray drift management
practices. The Agency is proposing interim mitigation measures for aerial applications that should be
placed on product labels/labeling as specified in Section V of this document. The Agency has
completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership
of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the
AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast, and
ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in
spray drift management practices to reduce off-target drift and risks associated with aerial as well as
other application types where appropriate. In the interim, labels should be amended to include the
following spray drift related language for products that are applied outdoors in liquid sprays (except
mosquito adulticides), regardless of application method: "Do not allow this product to drift."
V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation measures
outlined in Section IV and V, which include, among other things, submission of the following:
For products containing triallate. registrants need to submit the following items for each product within
eight months of the date of the product-specific DCI:
(1) an application for reregistration (EPA Form 8570-1, filled in, with a description on the
application, such as, "Responding to Reregistration Eligibility Decision" document);
(2) five copies of the draft label incorporating all label amendments outlined in Table 13 of this
document;
(3) responses to the generic and/or product specific DCIs as instructed in the enclosed DCIs;
(4) two copies of the Confidential Statement of Formula (CSF); and
(5) a certification with respect to data compensation requirements. Note that the first set of
required responses for the product-specific DCI is due 90 days from the receipt of the DCI.
The second set of required responses is due eight months from the date of the DCI. For
questions about product reregistration and/or the product-specific DCI, please contact Barbara
Briscoe at (703) 308-8177.
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For the generic PCI the following items are due:
(1) DCI response form, due 90 days from the receipt of the DCI;
(2) Registrant response form, due 90 days from the receipt of the DCI;
(3) the actual generic data in response to the DCI.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistation of triallate for the eligible uses has been reviewed
and determined to be substantially complete. The following confirmatory data are required:
Table 12: Generic Data Requirements
Guideline Test Name
Discussion of formation of impurities
Stability to normal and elevated temperatures, metals,
and metal ions
PH
UV/Visible Absorption
Partition coefficient (w-octanol/water), shake flask
method
Crop field trials (wheat hay)
Processed food/feed (barley)
Field accumulation in rotational crops
Aquatic invertebrate life-cycle (21 days) study
Aquatic plant growth studies
Surface drinking water monitoring study
New Guideline No.
OPPTS 830.1670
OPPTS 830.6313
OPPTS 830.7000
OPPTS 830.7050
OPPTS 830.7550
OPPTS 860.1500
OPPTS 860.1520
OPPTS 860.1900
NA
NA
OPPTS 835.7200
Old Guideline No.
61-2(b)
63-13
63-12
NA
63-11
171-4(k)
171-4(1)
165-2
72-4(b)
123-2
NA
Chemistry Studies
Pertinent product chemistry data requirements remain unfulfilled for the Monsanto 94% T/TGAI
concerning discussion of formation of impurities, stability, pH, UV/visible absorption, and octanol/water
partition coefficient (OPPTS 830.1670, 830.6313, 830.7000, 830.7050, and 830.7550). The
registrant must submit the data required in the attached data summary tables for the 94% T/TGAI, and
either certify that the suppliers of beginning materials and the manufacturing process for the triallate
technical product have not changed since the last comprehensive product chemistry review or submit a
complete updated product chemistry data package.
No additional data are required for wheat straw. Although a tolerance has not been established for
wheat forage, adequate data are available for this wheat raw agricultural commodity (RAC). Wheat
hay has now been included in Table 1 (OPPTS GLN 860.1000) as a significant livestock feed item.
Therefore, data depicting residues of triallate and its TCPSA metabolite in/on the hay of spring and
42
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winter wheat harvested following a single pre-emergence soil application of representative G and EC
formulations at 1.5 Ib ai/A are required. Separate (or side-by-side) field trials should be conducted for
each registered formulation. The trials must be conducted in the states of CO, ID, KS, MN, MT, NE,
NV, ND, OR, SD, UT, WA, and WY where regional registration is currently permitted. Wheat hay
samples should be analyzed within the storage intervals for which residues have been demonstrated to
be stable under frozen storage conditions. The registrant is required to propose tolerances for wheat
hay when acceptable data have been submitted and evaluated.
No additional data are required for barley straw. Barley hay has now been included in Table 1
(OPPTS GLN 860.1000) as a significant livestock feed item. The requested wheat hay data may be
translated to barley hay since the registered uses of triallate on barley and wheat are identical. The
registrant is required to propose a tolerance for barley hay when acceptable wheat hay data have been
received and evaluated.
A barley processing study utilizing an exaggerated application rate (or a rate equivalent to the maximum
theoretical concentration factor) is required. If the exaggerated field trial should result in non-
quantifiable residues of triallate and its TCPSA metabolite in/on the RAC (barley grain), then the
harvested RAC samples need not be processed, and tolerances for barley processed commodities will
not be required. However, if the exaggerated rate should produce quantifiable residues in/on the RAC,
then the harvested RAC samples should be processed into pearled barley, flour, and bran according to
method(s) simulating commercial practices. Each processed fraction should be analyzed for triallate
residues of concern.
Because triallate and TCPSA were detected in rotational crop commodities, the registrant is required to
conduct limited field rotational crop studies. The limited field trials are to be conducted on
representative crops of the root and tuber vegetables, leafy vegetables, and small grains at two sites per
crop for a total of six trials. The six trials are to be conducted on crops which the registrant intends to
have as rotational crops on the product labels. Samples are to be analyzed for residues of triallate and
TCPSA. If these limited field trials indicate that quantifiable triallate residues of concern will occur, then
extensive field rotational crop trials and rotational crop tolerances will be required. The need for
rotational crop restrictions will be determined following submission and evaluation of the required field
rotational crop studies.
Environmental Fate and Ecological Effects
Triallate ecotoxicity data are not sufficient in certain areas. An adequate battery of aquatic plant tests
(all 5 studies) is required to be conducted for this chemical. The registrant has attempted to provide
some limited aquatic plant data (one species), however this does not fulfill this data requirement.
Chronic testing of aquatic invertebrates is only partially acceptable as no determination of potential
effects to growth can be made. Presently, no exposure to estuarine habitats and organisms has been
considered due to triallate's exclusive use in the north central region of the United States. Future use
petitions involving crops which may expose estuarine organisms should be accompanied by acute and
chronic testing of estuarine fish and invertebrates (Guidelines 72-3 and 72-4).
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To address concerns regarding triallate concentrations in surface drinking water collection locations, the
registrant is required to conduct a surface drinking water monitoring study that measures raw and
finished triallate and TCPSA concentrations. The locations where measurements are to be taken shall
be based on factors that include high triallate use; small watersheds with a high percentage of land
planted to wheat; higher rainfall; and vulnerable soil conditions. Interim results of the surface water
monitoring data were provided to the Agency on February 16 and May 22, 2000. The preliminary
results indicate that the higher concentrations of triallate and TCPSA appear during the spring runoff,
and especially in smaller watersheds with higher rainfall. However, the results to date indicate that all
raw and finished measurements of peak and mean exposure to total parent triallate and TCPSA at all
five sites are below the cancer DWLOC (0.45 ppb). Additional monitoring data will be provided on a
quarterly basis, with a final report of the study expected in late 2002.
The Agency has evaluated the need for confirmatory environmental fate data for TCPSA. Because the
supplemental environmental fate data indicate it is highly mobile and moderately persistent in soil and
aquatic environments, the Agency believes that repeating the aerobic soil metabolism and
adsorption/desorption studies will not provide data that will alter the current environmental fate
assessment of TCPSA. Therefore, the Agency believes that confirmatory fate data for TCPSA are not
needed at this time.
2. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MUP) labeling should be revised to
comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling must
bear the labeling contained in the table at the end of this section, including the deletion of triallate use on
canary grass.
B. End-Use Products
1. Additional Product-Specific 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.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific language
to incorporate these changes is specified in Table 13 at the end of this section.
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C. Labeling Changes Summary Table
Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
One of these statements may
3e 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
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
The use on canary grass is
not being supported for
reregistration by the
registrant.
This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
This product may be used to formulate products for any additional use(s) not listed on the MP label
if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
:'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."
Delete the use on canary grass.
Directions for Use
End Use Products Intended for Occupational Use (all uses within the scope of WPS)
Handler PPE requirements for
emulsifiable concentrate (EC)
formulations that are
established by the RED and
aased on the active
ingredient.a
'Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are [registrant inserts correct material]. If
you want more options, follow the instructions for category [registrant insert A,B,C,D,E,F,G,orH] on
an EPA chemical-resistance category selection chart." a
'Mixers, loaders, applicators*, flaggers*, and other handlers must wear:
• Long-sleeved shirt and long pants
• Shoes plus socks
In addition, mixers, loaders, equipment cleaners, and other handlers exposed to the concentrate must
wear chemical-resistant gloves.
See engineering controls below for additional requirements"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
Handler PPE requirements for
janular (G) formulations that
are established by the RED
and based on the active
ingredient.a
'Personal Protective Equipment (PPE)"
'Loaders, applicators*, flaggers*, and other handlers must wear:
• Long-sleeved shirt and long pants
• Shoes plus socks
In addition, loaders must wear:
• A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter" b
'* See engineering controls below for additional requirements"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety Requirements
'Discard clothing or other absorbent materials that have been drenched or heavily contaminated with
this product's concentrate. Do not reuse them."
'Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
•equirements
Engineering Controls
'Engineering Controls"
'Pilots must use an enclosed cockpit that meets the requirements listed in the Worker Protection
Standard (WPS) for Agricultural Pesticides [40 CFR 170.240(d)(6)]."
:'Flaggers must be in an enclosed cab that meets the definition in the Worker Protection Standard for
Agricultural Pesticides for dermal protection and in addition to wearing the required PPE specified
above, have immediately available for use in case they must leave the cab: coveralls, chemical-
resistant gloves, and chemical-resistant footwear."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following PPE and User
Safety Requirements.)
User Safety
Recommendations
'User Safety Recommendations"
'Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
'Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing."
:'Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to
Humans and Domestic
Animals immediately
following Engineering
ontrols
(Must be placed in a
box.)
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Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
Environmental Hazards
'Environmental Hazards"
'Do not apply directly to water, or to areas where water is present or to intertidal areas below the mean
high water mark. Do not contaminate water when cleaning equipment or disposing of equipment
washwaters."
'•round Water Advisory
'Triallate has a degradation product with properties and characteristics associated with chemicals
detected in ground water. The use of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground water contamination."
Surface Water Advisory
'Under some conditions, the triallate degradate TCPSA may have a high potential for runoff into
surface water (primarily via dissolution in runoff water). These include poorly draining or wet soils
with readily visible slopes toward adjacent surface waters, frequently flooded areas, areas over-laying
extremely shallow ground water, areas with in-field canals or ditches that drain to surface water, areas
not separated from adjacent surface waters with vegetated filter strips, and areas over-laying tile
drainage systems that drain surface water."
Precautionary Statements
under Environmental
Hazards
Restricted-Entry Interval
For WPS products as required
ay Supplement Three of PR
Notice 93-7
'Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12
hours."
"Do not enter or allow others to enter the treated area (except those persons involved in the
incorporation) until the incorporation is complete following application."
Early Re-entry Personal
Protective Equipment for
Products subject to WPS as
required by Supplement Three
of PR Notice 93-7.
:'PPE required for early entry to treated areas that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated, such as plants, soil, or water, is:"
"coveralls
chemical-resistant gloves, such as or made out of any waterproof material
shoes plus socks"
Directions for Use,
Agricultural Use
Requirements Box
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."
'Do not allow this product to drift."
Place in the Direction for
Use directly above the
Agricultural Use Box.
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Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
Spray Drift language that
must be placed on each
product that can be applied
aerially:
'Aerial Spray Drift Management"
'Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of
many equipment-and-weather-related factors determine the potential for spray drift. The applicator
and the grower are responsible for considering all these factors when making decisions."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
'The following drift management requirements must be followed to avoid off-target drift movement
from aerial applications to agricultural field crops. These requirements do not apply to forestry
applications, public health uses or to applications using dry formulations.
1 .The distance of the outermost nozzles on the boom must not exceed 3/4 the length of the wingspan
or rotor.
2.Nozzles must always point backward parallel with the air stream and never be pointed downwards
more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the Aerial Drift
Reduction Advisory Information."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"Aerial Drift Reduction Advisory"
'This section is advisory in nature and does not supersede the mandatory label requirements."
'INFORMATION ON DROPLET SIZE
'The most effective way to reduce drift potential is to apply large droplets. The best drift management
strategy is to apply the largest droplets that provide sufficient coverage and control. Applying larger
droplets reduces drift potential, but will not prevent drift if applications are made improperly, or under
unfavorable environmental conditions (see Wind, Temperature and Humidity, and Temperature
Inversions)."
Directions for Use
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Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
The following language must
be placed on each product
that can be applied aerially:
'CONTROLLING DROPLET SIZE
' ! Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with
higher rated flows produce larger droplets.
! Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many nozzle types
lower pressure produces larger droplets. When higher flow rates are needed, use higher flow rate
nozzles instead of increasing pressure.
! Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
! Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream produces
larger droplets than other orientations and is the recommended practice. Significant deflection from
horizontal will reduce droplet size and increase drift potential.
! Nozzle Type - Use a nozzle type that is designed for the intended application. With most nozzle
types, narrower spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream
nozzles oriented straight back produce the largest droplets and the lowest drift."
Directions for Use
The following language must
3e placed on each product
:hat can be applied aerially:
'BOOM LENGTH"
Tor some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or rotor
length may further reduce drift without reducing swath width."
Directions for Use
The following language must
3e placed on each product
:hat can be applied aerially:
'APPLICATION HEIGHT"
'Applications should not be made at a height greater than 10 feet above the top of the largest plants
unless a greater height is required for aircraft safety. Making applications at the lowest height that is
afe reduces exposure of droplets to evaporation and wind."
Directions for Use
49
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Table 13. Summary of Labeling Changes for Triallate
Description
Amended Labeling Language
Placement on Label
The following language must
be placed on each product
that can be applied aerially:
'SWATH ADJUSTMENT"
'When applications are made with a crosswind, the swath will be displaced downwind. Therefore, on
the up and downwind edges of the field, the applicator must compensate for this displacement by
adjusting the path of the aircraft upwind. Swath adjustment distance should increase, with increasing
drift potential (higher wind, smaller drops, etc.)"
Directions for Use
The following language must
be placed on each product
:hat can be applied aerially:
'WIND"
'Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including droplet
size and equipment type determine drift potential at any given speed. Application should be avoided
below 2 mph due to variable wind direction and high inversion potential. NOTE: Local terrain can
influence wind patterns. Every applicator should be familiar with local wind patterns and how they
affect spray drift."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"TEMPERATURE AND HUMIDITY
:'When making applications in low relative humidity, set up equipment to produce larger droplets to
compensate for evaporation. Droplet evaporation is most severe when conditions are both hot and
dry."
Directions for Use
The following language must
3e placed on each product
:hat can be applied aerially:
'TEMPERATURE INVERSIONS
'Applications should not occur during a temperature inversion because drift potential is high.
Temperature inversions restrict vertical air mixing, which causes small suspended droplets to remain in
a concentrated cloud. This cloud can move in unpredictable directions due to the light variable winds
common during inversions. Temperature inversions are characterized by increasing temperatures with
altitude and are common on nights with limited cloud cover and light to no wind. They begin to form
as the sun sets and often continue into the morning. Their presence can be indicated by ground fog;
however, if fog is not present, inversions can also be identified by the movement of smoke from a
ground source or an aircraft smoke generator. Smoke that layers and moves laterally in a concentrated
cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and rapidly
dissipates indicates good vertical air mixing."
Directions for Use
50
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Table 13. Summary of Labeling Changes for Triallate
Description
The following language must
be placed on each product
that can be applied aerially:
Other Use/Application
Restrictions.
Amended Labeling Language
"SENSITIVE AREAS"
The pesticide should only be applied when the potential for drift to adjacent sensitive areas (e.g.
residential areas, bodies of water, known habitat for threatened or endangered species, non- target
crops) is minimal (e.g. when wind is blowing away from the sensitive areas)."
:'Application is limited to one per growing season and must not exceed 1.5 pounds of active
ingredient per acre."
Placement on Label
Directions for Use
Directions for Use under
General Precautions and
restrictions and/or
Applications Instructions
a PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
b Note that if a product contain oil or has instructions that would allow concurrent application with an oil-containing material, registrants must remove the "N" in
the respirator statement.
51
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D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from the
date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the registrant
may generally distribute or sell such products for 50 months from the date of the issuance of this 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 registrants may distribute and sell triallate products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant
may distribute or sell such products for 50 months from the date of the issuance of this RED.
Registrants and persons other than registrants remain obligated to meet pre-existing label requirements
and existing stocks requirements applicable to products they sell or distribute.
52
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VI. APPENDICES
53
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Appendix A. Table of Use Patterns Eligible for Reregistration
Application Timing
Application Type
Application Equipment
Formulation
[EPA Reg. No.]
Max Single
Application Rate
(Ib ai/A)
Max No. of
Applications/
Season
Max Seasonal
Rate (Ib ai/A)
Preharvest
Interval (Days)
Use Limitations
Barley
Fall or spring
Pre-emergence soil
incorporated
Ground/Aerial
10% G
[524-291]
[524-292]
[524-375]
4 Ib/gal EC
[524-145]
1.5
1
1.5
Not Required
(NR)
Use limited to the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT,
WA,andWY.
Lentils
Spring
Pre-emergence soil
incorporated
Ground/Aerial
10% G
[524-292]
4 Ib/gal EC
[524-145]
1.5
1
1.5
NR
Use limited to the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT,
WA,andWY.
Peas (Including Green, Field, Chickpeas, and Garbanzo Beans)
Spring
Pre-emergence soil
incorporated
Ground/Aerial
10% G
[524-292]
[524-375]
4 Ib/gal EC
[524-145]
1.5
1
1.5
NR
Use limited to the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT,
WA,andWY.
Triticale
Spring
Pre-emergence soil
incorporated
Ground/Aerial
10% G
[524-292]
4 Ib/gal EC
[524-145]
1.5
1
1.5
NR
Use limited to the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT,
WA,andWY.
Wheat
54
-------
Application Timing
Application Type
Application Equipment
Fall or spring
Pre-emergence soil
incorporated
Ground/Aerial
Formulation
[EPA Reg. No.]
10% G
[524-291]
[524-292]
[524-375]
4 Ib/gal EC
[524-145]
Max Single
Application Rate
(Ib ai/A)
1.5
Max No. of
Applications/
Season
1
Max Seasonal
Rate (Ib ai/A)
1.5
Preharvest
Interval (Days)
NR
Use Limitations
Use limited to the states of CO, ID, KS,
MN, MT, NE, NV, ND, OR, SD, UT,
WA,andWY.
55
-------
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 reregistration for active ingredients
within the case covered by this RED. It contains generic data requirements that apply 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, 2, & 3). The data requirements are listed in the order of
Old Guideline Number and 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 4). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use
patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 5). 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 (MRID) 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.
56
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Old Guideline
Number
(61-2b)
(63-11)
(63-12)
(63-13)
none
(71-1)
(71-2)
(71-4)
(72-1)
(72-1)
(72-2)
(72-2)
(72-4)
(72-4b)
(123-1)
(123-la)
(123-2)
(141-1)
(141-2)
New
Guideline
Number
830.1670
830.7550
830.7000
830.6313
830.7050
850.2100
850.2200
850.2300
850.1075
850.1075
850.1010
850.1010
850.1400
none
850.4250
850.4225
none
850.3020
850.3030
Requirement
PRODUCT CHEMISTRY
Discussion of formation of impurities
Partition coefficient (n-octanol/water),
shake flask method
PH
Stability to normal and elevated
temperatures, metals, and metal ions
UV/Visible Absorption
ECOLOGICAL EFFECTS
Avian acute oral toxicity - bobwhite quail
Avian dietary toxicity test
Avian reproduction test
Fish acute toxicity test - bluegill
Fish acute toxicity test - rainbow trout
Aquatic invertebrate acute toxicity,
freshwater - daphnia magna (21 day study)
Aquatic invertebrate acute toxicity,
freshwater - daphnia magna
Fish early-life stage toxicity test - rainbow
trout
Aquatic invertebrate life-cycle (21 day)
study
Vegetative vigor
Seedling emergence
Aquatic plant growth studies
Honey bee acute contact toxicity
Honey bee toxicity of residues on foliage
Use Pattern
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Citation(s)
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
ACC244201 / MRID 3035
40730602,
40730603
44700701
ACC 24 196 11 MRID
29471,
ACC 245 191 /MRID 76892
ACC 245 191 /MRID 76891
41896601
41895601,
ACC 24 1961 /MRID 29470
44660901
Data Gap
42471701
42471801
Data Gap
42304301
44700801
TOXICOLOGY
(81-1)
870 . 1 1 00 [Mammalian acute oral - rat
A,B
00109746,44660701
57
-------
Old Guideline
Number
(81-2)
(81-3)
(81-4)
(81-5)
(81-6)
(81-7)
(81-7)
(81-8)
(82-1)
(82-2)
(82-4)
(82-7)
(83-1)
(83-la)
(83-2)
(83-2)
(83-2)
(83-3)
(83-3)
(83-4)
(83-6)
(84-2)
(84-2)
(84-2)
New
Guideline
Number
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6100
870.6200
870.3100
870.3200
none
870.6200
870.4100
870.4100
870.4200
870.4200
870.4200
870.3700
870.3700
870.3800
870.6300
870.5395
870.5300
870.5385
Requirement
Acute dermal - rabbit
Acute inhalation - rat
r'rimary eye irritation - rabbit
r'rimary dermal irritation - rabbit
Dermal sensitization - guinea pig Buehler
Test
Acute delayed neurotoxicity - hen
Mammalian acute oral - rat (1 day dietary-
neurotoxicity)
Acute neurotoxicity - rat
90-Day feeding - rat
21 -Day dermal -rat
Subchronic inhalation (6 hr/day 5
days/week for 7 weeks) - rat
Subchronic neurotoxicity - rat
Chronic toxicity - dogs
Mammalian chronic dietary - rat
Chronic toxicity/
carcinogenicity - rat
Chronic toxicity/
carcinogenicity - mice
Chronic toxicity/
carcinogenicity - hamster
Developmental toxicity - rat
Developmental toxicity - rabbit
2-Generation reproduction study - rat
Developmental neurotoxicity - rat
Cytogenetics / In vivo mouse
micronucleus assay
Gene mutation / In vitro mammalian cell
assay in mouse lymphoma cells
Cytogenetics / In vivo hamster
micronucleus assay
Use Pattern
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Citation(s)
42192001
00121856
44591801
44581601
00132879
00132874,
40072104
42908101
42908101
00115639,44767501
41487001
40072105,
00132878
44694501,
43021601
00029455,
40730604
40384701,44767501
40384701,
41116901
00132859
00151790,
00159797
00114260,
41706906
00114261,
43315001
00144308,
00132880
44710501
44591701
00083644,
41091007
00114263
58
-------
Old Guideline
Number
(84-2)
(84-2)
(84-2)
(84-2)
(85-1)
(85-1)
New
Guideline
Number
870.5100
870.5550
870.5550
870.5900
870.7485
870.7485
Requirement
Gene mutation in Salmonella typhimurium
Other mutagenic mechanisms / In vivo 1 In
vitro unscheduled DNA synthesis in
primary rat hepatocytes
Other mutagenic mechanisms / In vitro
unscheduled DNA synthesis in primary
rat hepatocytes
Other mutagenic mechanisms / In vitro
sister chromatid exchange in Chinese
tiamster ovary cells
General metabolism - rat
General metabolism - rat
Use Pattern
A,B
A,B
A,B
A,B
A,B
A,B
Citation(s)
00088624
44701001
40730601
00121859
00138159
40072106
ENVIRONMENTAL FATE
(161-1)
(161-2)
(161-3)
(162-1)
(162-2)
(163-1)
(163-2)
(163-3)
(164-1)
(165-2)
(165-4)
none
835.2120
835.2240
835.2410
835.4100
835.4200
835.1230
835.1410
835.8100
835.6100
860.1900
850.1730
835.7200
Hydrolysis study
Photodegradation in water
Photodegradation on soil
Aerobic soil metabolism
Anaerobic soil metabolism
Leaching and adsorption /desorption
studies
Laboratory volatility from soil
Field volatility
Terrestrial field dissipation
Field accumulation in rotational crops
Laboratory studies of pesticide
accumulation in fish
Surface drinking water monitoring study
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00144567
00144567, 41541301
00144567,41892301
00144567,92187028,
44611302,44715601
00144567,92187054,
44611302
00144567,44611302
42651101
Majewski and Capel, 1995
00145426
Data Gap
41497601,43021201
Data Gap
RESIDUE CHEMISTRY
(171-4k)
(171-41)
860.1500
860.1520
Crop field trials (wheat hay)
Processed food/feed (barley)
A,B
A,B
Data Gap
Data Gap
59
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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.
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/
60
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for studies in this bibliography have been
the body of data submitted to EPA and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the published literature, in those instances
where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The
Agency has also attempted to unite basic documents and commentaries upon them, treating
them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the
review may be preceded by a nine character temporary identifier. These entries are listed after
all MRID entries. This temporary identifying number is also to be used whenever specific
reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA, by
a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for certain
special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
61
-------
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.
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.
62
-------
MRID # CITATION
29455 Drescher, W.; Mastalski, K.; Fletcher, D.; et al. (1979) Status Report to Monsanto
Company: Two-Year Chronic Oral Toxicity Study with Triallate Technical in Beagle
Dogs: IBT No. 8580-10581. (Unpublished study including letters dated Nov 21, 1979
and Feb 12, 1980 from M.G. Robl to F.C. Meyer, Mar 4, 1980 from B.Y. Cockrell to
Myron S. Weinberg and Mar 10, 1980 from M.S. Weinberg to George Levinskas,
report nos. MSL-0458 and MSL-0986, undated method and addendum, received
Mar 17, 1980 under 524-124; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL:242057-A)
83644 Brusick, DJ. (1977) Mutagenicity Evaluation of CP 23426 in the Mouse Lymphoma
Assay: LBI Project No. 2684. Final rept. (Unpublished study received Mar 30, 1978
under 524-124; prepared by Litton Bionetics, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:233353-B)
88624 Brusick, DJ. (1977) Mutagenicity Evaluation of CP 23426: LBI Project No. 2683.
Final rept. (Unpublished study received Mar 30, 1978 under 524-124; prepared by
Litton Bionetics, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:233353-C)
109746 Auletta, C.; Rinehart, W. (1979) Acute Oral Toxicity study in Rats: [Triallate]: Project
No. 4919-77. (Unpublished study received Oct 16, 1979 under 524-145; prepared
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington, DC; CDL:241271-J)
114260 Alvarez, L.; Kier, L.; Folk, R. (1982) Triallate-a Teratology Study in the Rat: Study
No. 800320/ML 80-493. Final rept. (Unpublished study received Sep 8, 1982 under
524-124; submitted by Monsanto Co, Washington, DC; CDL:248293-A)
114261 Schardein, 1; Laughlin, K.; Blair, M.; et al. (1982) Teratology Study in Rabbits
(IR-80-087): 401-146. (Unpublished study received Sep 8, 1982 under 524-124;
prepared by International Research and Development Corp, submitted by Monsanto
Co, Washington, DC; CDL:248293-B)
114263 Blazak, W. (1982) An Evaluation of the Mutagenic Potential of Triallate Employing the
in vivo Cytogenetics Assay in Syrian Golden Hamsters: SRI Project LSC-2537-1;
Monsanto Study No. SI-80-478/ML-80-142. Final rept. (Unpublished study
received Sep 8, 1982 under 524-124; prepared by SRI International, submitted by
Monsanto Co, Washington, DC; CDL:248294-B)
115639 Stout, L.; Thake, D.; Folk, R. (1982) Three Month Feeding Study of Triallate
Technical in Male and Female Sprague-Dawley Rats: Report No. MSL-2458. Final
63
-------
MRID # CITATION
rept. (Unpublished study received Oct 5, 1982 under 524-124; submitted by
Monsanto Co., Washington, DC; CDL:248539-A)
121856 Velasquez, D.; Roloff, M.; Folk, R. (1982) Acute Toxicity of Triallate Administered by
Inhalation to Sprague-Dawley Male and Female Rats: Job/Project No.
ML-81-318/81031. Final rept. (Unpublished study received Dec 22, 1982 under
524-124; submitted by Monsanto Co., Washington, DC; CDL:071283-F)
121859 Loveday, K.; Donahue, B. (1982) In vitro Sister Chromatid Exchange Assay in
Chinese Hamster Ovary Cells Treated with Triallate Technical: Project No. 10842;
Project No. BA-81-299. (Unpublished study received Dec 22, 1982 under 524-124;
prepared by Bioassay Systems Corp., submitted by Monsanto Co., Washington, DC;
CDL:071284-B)
132859 Stout, L.; Ruecker, F.; Thake, D.; et al. (1983) Two Year Study of Triallate
Administered in Feed to Mice: Report No. MSL-3196. Final rept. (Unpublished
study received Nov 30, 1983 under 524-124; submitted by Monsanto Co.,
Washington, DC; CDL:251837-A; 25 1838; 251839)
132874 Abou-Donia, M. (1983) Effect of a Single Oral Dose of Triallate on Hens: Project No.
DU-81-266. Final rept. (Unpublished study received Nov 30, 1983 under 524-124;
prepared by Duke Univ. Medical Center, Dept. of Pharmacology, submitted by
Monsanto Co., Washington, DC; CDL:251840-B)
132878 Velasquez, D.; Thake, D.; Roloff, M.; et al. (1983) Seven-week Toxicity Study of
Triallate Administered to Male and Female Sprague-Dawley Rats by Inhalation: Report
No. MSL-3192. Final rept. (Unpublished study received Nov 30, 1983 under
524-124; submitted by Monsanto Co., Washington, DC; CDL:251840-F)
132879 Auletta, C.; Loder, C.; Daly, I; et al. (1983) A Dermal Sensitization Study in Guinea
Pigs: [Triallate]: Bio/dynamics Project No. 4265-83; Monsanto Reference No.
BD-83-020. (Unpublished study received Nov 30, 1983 under 524-124; prepared by
Bio/dynamics, Inc., submitted by Monsanto Co., Washington, DC; CDL: 251840-G)
132880 Kier, L.; Alvarez, L.; Ribelin, W.; et al. (1983) Triallate Technical: A Two Generation
Reproduction Study in the Rat: Study No. 820123. Interim rept. (Unpublished study
received Nov 30, 1983 under 524-124; submitted by Monsanto Co., Washington,
DC;CDL:251841-B)
64
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MRID#
CITATION
138159 Suba, L. (1983) Rat Metabolism Data: [Triallate]: Special Report MSL-3286.
(Unpublished study received Jan 13, 1984 under 524-124; submitted by Monsanto
Co., Washington, DC; CDL:252186-A; 252187; 252188)
144308 Kier, L.: Ribelin, W. (1984) Triallate Technical: A Two Generation Reproduction
Study in the Rat: Final Report: Report No. MSL-3651. Unpublished study prepared
by Monsanto Co. 1254 p.
144567 Sutherland, M.; Banduhn, M.; Purdum, W. (1985) The Environmental Chemistry
Studies of Triallate, N,N-Di-(l-methylethyl)-S-(2,3,3-trichloro-2-propenyl)
thiocarbamate: Report No. MSL-3527. Unpublished study prepared by Monsanto
Co. 116 p.
145426 Klein, A.; Lauer, R; Horner, L.; et al. (1985) Dissipation of Triallate and the Major
Metabolite of Triallate from Field Treated Soils after Treatment with Far-Go EC or
Avadex BW Herbicides: Project No. 7112. Unpublished study prepared by Monsanto
Co. and Analytical Biochemistry Laboratories. 148 p.
151790 Adams. R. (1984) Lifetime Chronic/Oncogenicity Study of Triallate Technical
Administered Orally to Syrian Golden Hamsters: Final Report: C-253 (BR-81-245).
Unpublished study prepared by Bio-Research Consultants, Inc. 913 p.
159797 Groya, F., comp. (1986) Addendum to the Chronic Toxicity/Oncogenicity Feeding
Study in Hamsters: R.D. No. 679: Special Report MSL-5695. Unpublished study
prepared by Monsanto Agricultural Co. 96 p.
40072104 Abou-Donia, M. (1986) Effect of a Single Oral Dose of Triallate on Hens: ?Additional
Information Relating to the Previously submitted Study: Study No. DU-81-266.
Unpublished study prepared by Duke Univ. Medical Center-Durham, North Carolina.
15 p.
40072105 Velasquez, D.; Thake, D. (1986) Seven-Week Toxicity Study of Triallate
Administered to Male and Female Sprague-Dawley Rats by Inhalation: ? Additional
Information Relating to the Previously Submitted Study: Study No. ML-82-214.
Unpublished study prepared by Monsanto Chemical Co. 7 p.
40072106 Nadeau, R.; Chott, R. (1986) The Metabolism of Triallate in the Laboratory Rat, Part
U: Identification, Characterization, and Quantification of Triallate and its Metabolite
After Oral Administration: ? Additional Information Relating to the Previously
65
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MRID#
CITATION
Submitted Study: Study No. MSL-3123. Unpublished study prepared by Monsanto
Chemical Co. 16 p.
40384701 Stout, L.; Thake, D. (1987) Chronic Study of Triallate Administered in Feed to
Sprague/Dawley Rats: R.D. No. 812: Laboratory Project No. EHL-83119.
Unpublished study prepared by Monsanto Environmental Health Laboratory. 2732 p.
40730601 Bake, 1; Mirsalis, J. (1985) Evaluation of the Potential of Triallate to Induce
Unscheduled DNA Synthesis in Primary Rat Heptocyte Cultures: Project ID
LSC-8747-2. Unpublished study prepared by SRI International. 17 p.
40730602 Hinken, C.; Grimes, J. (1986) Triallate: A Dietary LC50 Study with the Mallard:
Project ID. 139-230. Unpublished study prepared by Wildlife International LTD. 24
P-
40730603 Grimes, J.; Jaber, M. (1986) Triallate: A Dietary LC50 Study with the Bobwhite:
Project ID. 139-229. Unpublished study prepared by Wildlife International LTD. 24
P-
40730604 Reyna, M.; Thake, D. (1988) One Year Study of Triallate Administered Orally by
Gelatin Capsule to Beagle Dogs: Project ID. 85009 (MSL-7640). Unpublished study
prepared by Monsanto Agricultural Co. 336 p.
41091007 Job, M.; Mitchell, A. (1980) An Evaluation of Mutagenic Potential of Triallate
Employing the L5178Y TK+/- Mouse Lymphoma Assay: SRI Proj. LSU-7558.
Unpublished study prepared by SRI International. 15 p.
41116901 Vigneault, T. (1988) Confirmatory Efficacy Data: Low Foam Tops: Proj. ID M81134.
Unpublished study prepared by Northview Laboratories, Inc. 3 p.
41487001 Siglin, J. (1990) 21-Day Dermal Toxicity Study in Rats with Triallate: SLS Study No.:
3044.19; Monsanto Study No. SB-89-420; RD. No. 986. Unpublished study
prepared by Springborn Laboratories, Inc., Mammalian Toxicology Div. 180 p.
41497601 Burgess, D. (1989) Uptake, Depuration, and Bioconcentration of [carbon 14]-Triallate
by Bluegill Sunfish (Lepomis macrochirus), Part I. (Part H: MSL-9549): Lab Project
Number: MSL-9548. Unpublished study prepared by Monsanto Agricultural Co. 396
P-
66
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MRID#
CITATION
41541301 Detra, R., Davis, M., Zwick, T. et al. (1990) Photodegradation of [Carbon-14]
Triallate in Water under Artificial Light: Lab Project Number: SC890020: 89-12-M27.
Unpublished study prepared by Battelle. 52 p.
41706906 Kier, L. (1990) Triallate: A Teratology Study in the Rat: Addendum: Lab Project
Number: EHL 800320. Unpublished study prepared by Monsanto, Co. 51 p.
41892301 Jackson, S.; Wick, M.; Kesterson, A. (1991) Soil Surface Photolysis of [carbon
14]-Triallate in Natural Sunlight: Lab Project Number: 1334: 500. Unpublished study
prepared by PTRL East, Inc. 69 p.
41895601 McNamara, P. (1990) Triallate-the Chronic Toxicity to Daphnia magna Under
Flow-through Conditions: Lab Project Number: SB-89-122:1046. Unpublished study
prepared by Springborn Laboratories, Inc. 64 p.
42192001 Bonnette, K. (1991) Acute Dermal Toxicity Study in Rats with Triallate: Final Report:
Lab Project Number: SB-91-173. Unpublished study prepared by Springborn Labs.,
Inc. 14 p.
42304301 Hoxter, K.; Lynn, S. (1992) Triallate: An Acute Contact Study with the Honey Bee:
Lab Project Number: R. D. 1091. Unpublished study prepared by Wildlife
International LTD. 14 p.
42471701 Chetram, R. (1992) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using
Triallate: Lab Project Number: BL91-482: RD. 1125: 0612-91-2. Unpublished study
prepared by Pan-Agricultural Laboratories Inc. 205 p.
42471801 Chetram, R. (1992) Tier 2 Germination/Seedling Emergence Nontarget Phytotoxicity
Study Using Triallate: Lab Project Number: BL91-483]: 0612-91-1: RD. 1126.
Unpublished study prepared by Pan-Agricultural Laboratories Inc. 219 p.
42499701 Kimmel, E.; Montenegro, X.; Sprinkle, R. (1992) A Confined Rotational Crop Study
with carbon 14-Triallate Using Radishes (Raphanus sativus), Lettuce (Lactuca Sativa),
and Wheat (Triticum aestivum): Lab Project Number: 504 (E). Unpublished study
prepared by PTRL-West, Inc. 249 p.
42651101 Shepler, K.; Estigoy, L. (1993) Laboratory Volatility of (carbon 14)-Triallate: Lab
Project Number: 399W: 1157. Unpublished study prepared by PTRL-West, Inc. 63
P-
67
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MRID#
CITATION
42908101 Li, A.; Thake, D.; Branch, D.; et al. (1993) Acute Neurotoxicity Study of Triallate in
Sprague-Dawley Rats: Final Report: Lab Project Number: EHL 92021: EHL 92020:
ML-92-065. Unpublished study prepared by Monsanto Co., Agricultural Group. 416
P-
43021201 Heitkamp, J.; Halls, T. (1993) Characterization of (carbon 14)-Triallate Residue in
Bluegill (Lepomis macrochirus) Water and Tissue: Amended Final Report: Lab Project
Number: 37194:MSL 9549: 1213. Unpublished study prepared by Analytical
Bio-chemistry Labs, Inc. 73 p.
43021601 Li, A; Branch, D.; Thake, D.; et al. (1993) Subchronic Neurotoxicity of Triallate in
Sprague-Dawley Rats: Lab Project Number: ML-92-384: EHL 92125: RD 1199.
Unpublished study prepared by Monsanto Co., Agricultural Group. 587 p.
43315001 Li, A. (1994) Triallate Rabbit Teratology Study: Addendum: Individual Animal
Observations: Lab Project Number: RD 1258: IR-80-087. Unpublished study
prepared by International Research and Development Corp. 155 p.
44308301 Blaszcak, D. (1997) Guinea Pig Maximization Test with Triallate: (Method of
Magnusson and Kligman): Final Report: Lab Project Number: 96-1541: HU-96-252.
Unpublished study prepared by Huntingdon Life Sciences. 36 p.
44581601 Blaszcak, D. (1998) Primary Dermal Irritation Study in Rabbits with Triallate: Lab
Project Number: 96-1539: HU-96-251: 1402. Unpublished study prepared by
Huntingdon Life Sciences. 24 p.
44591701 Stegeman, S.; Kier, L. (1997) Mouse Bone Marrow Micronucleus Assay of Triallate:
Final Report Amendment 1: Lab Project Number: ML-90-375: EHL 90165: RD
1401. Unpublished study prepared by Monsanto Company (EHL). 48 p.
44591801 Blaszcak, D. (1998) Primary Eye Irritation Study in Rabbits with Triallate: Final Report:
Lab Project Number: RD 1422: 96-1540: HU-96-250. Unpublished study prepared
by Huntingdon Life Sciences. 31 p.
44611302 Oppenhuizen, M. (1983) The Comparative Environmental Chemistry Studies with
Encapsulated and Unencapsulated Triallate: Lab Project Number: RD 1426: 3229.
Unpublished study prepared by Monsanto Co. 57 p.
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MRID#
CITATION
44660701 Blaszcak, D. (1998) Acute Oral Toxicity Study in Rats with Triallate: Lab Project
Number: R.D.1439: 96-1538: HU-96-249. Unpublished study prepared by
Huntingdon Life Sciences. 84 p.
44660901 Drottar, K.; Swigert, J.; Krueger, H. (1998) Triallate: An Early Life-Stage Toxicity
Test with the Rainbow Trout (Oncorhynchus mykiss): Lab Project Number:
139A-198B: WL-96-278: RD.1438. Unpublished study prepared by Wildlife
International Ltd. 85 p.
44694501 Li, A.; Thake, D.; Branch, D. et al. (1998) Assessment of Brain Pathology in
Sprague-Dawley Rats Exposed to Triallate for Five Weeks in the Diet: Lab Project
Number: ML-94-314: 94094: RD 1443. Unpublished study prepared by
Neuroscience Associates and Monsanto Company. 258 p.
44700801 Hoxter, K.; Bernard, W.; Beavers, J. (1993) Technical Grade Triallate: A Dietary
LC50 Toxicity Study with the Honey Bee (Apis mellifera): Lab Project Number:
WL-92-264: RD 1450: 139-339. Unpublished study prepared by Wildlife
International Ltd. 17 p.
44701001 Bakke, J. (1989) Evaluation of the Potential of Triallate to Induce Unscheduled DNA
Synthesis in the In Vivo-In Vitro Hepatocyte DNA Repair Assay in the B6C3F1
Mouse: Lab Project Number: SR-89-186: RD 1403. Unpublished study prepared by
SRI International. 31 p.
44710501 Lemen, J.; Kaempfe, A.; Thake, D. et al. (1998) Developmental Neurotoxicity Study
of Triallate Administered to Pregnant/Lactating CD Rats: Lab Project Number:
ML-97-129: MSE-N 97002: RD 1451. Unpublished study prepared by Monsanto
Company. 1528 p.
44715501 Mackie, J. (1998) The Aerobic Degradation of (carbon 14)-Triallate in Natural
Sediment/Water Systems: Lab Project Number: 390990: MSL-15172. Unpublished
study prepared by Inveresk Research. 70 p.
44715502 Elliot, R; Klemm, G. (1987) The Aquatic Metabolism of Triallate in Surface Water:
Lab Project Number: MSL 6162. Unpublished study prepared by Monsanto
Company. 62 p.
44715601 Mackie, J.; Saunders, L. (1998) The Degradation of (carbon 14)-Triallate in Soil
Under Aerobic Conditions: Lab Project Number: 15908: MSL-15173. Unpublished
study prepared by Inveresk Research. 88 p.
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MRID # CITATION
44767501 Swenberg, J.; Schoonhoven, R.; Alden, C. et al. (1999) Immunohistochemical
Evaluation of Alpha2u-Globulin in Rat Kidneys from a Previously Conducted
Three-Month Study Triallate: Lab Project Number: XX-94-126: RD 1452: 98083.
Unpublished study prepared by The University of North Carolina at Chapel Hill, and
Searle, a Division of Monsanto. 41 p.
92187028 Keene, E. (1990) Monsanto Company Phase 3 Summary of MRID 00144567. The
Environmental Chemistry Studies of Triallate: Monsanto RD #618. Prepared by
Monsanto Agricultural Products Co. 13 p.
92187054 Keene, E. (1990) Monsanto Company Phase 3 Summary of MRID 00144567. The
Environmental Studies of Triallate: Monsanto RD #618. Prepared by Monsanto
Agricultural Products Co. 13 p.
ACC 241961 / MRID 29470
Thompson, C.M.; Forbis, A.D.; Oleson, F.B. (1979) Acute Toxicity of Triallate
Technical (AB-79-073) to Daphnia magna: Static Acute Bioassay Report #24012.
(Unpublished study received March 4, 1980 under 524-145; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:241961-C).
ACC 241961 / MRID 24971
Thompson, C.M., McAllister, W.A.; Griffen, J.R.; et al. (1979) Acute Toxicity of
Triallate (AB-79-072) to Bluegill Sunfish (Lepomis macrochirus): Static Acute
Bioassay Report #24011. (Unpublished study received March 4, 1980 under 524-
145; prepared by Analytical Bio Chemistry Laboratories, Inc., submitted by Monsanto
Co., Washington, D.C.; CDL:241961-D).
ACC 244201 / MRID 3035
Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Acute Oral LD50-
Bobwhite Quail: Project No. 139-184. (Unpublished study received January 29, 1981
under 524-124; prepared by Wildlife International, LTD. and Washington College,
submitted by Monsanto Co., Washington, D.C.; CDL:244201-A).
ACC 245191/MRID 76891
Thompson, C.M.; Griffen, J. (1981) Acute Toxicity of Avadex Granular (Lot No.
MUWG 0908)(AB-80-523) to Rainbow Trout: Static Acute Bioassay Report
#26883. (Unpublished study, including letter dated March 9, 1981 from R.B. Oleson
to E.G. Spurrier, received May 18, 1981 under 524-124; prepared by Analytical Bio
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MRID # CITATION
Chemistry Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:245191-A).
ACC 245191 / MRID 76892
Thompson, C.M.; Griffen, J. (1981) Acute Toxicity of Avadex Granular (Lot No.
MUWG 0908) (AB-80-524) to Bluegill Sunfish: Static Acute Bioassay Report #
26884. (Unpublished study, including letter dated March 9, 1981 from R.B. Oleson to
E.G. Spurrier, received May 18, 1981 under 524-124; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:245191-B).
ACC 245961 / MRID 80897
Smith, S.H.; O'Loughlin, C.K.; Salamon, C.M.; et al. (1981) Two-generation
Reproduction Study in Albino Rats with Metolachlor Technical: Study No. 450-0272.
Final rept. (Unpublished study received Sep 30, 1981 under 100-597; prepared by
Whittaker Corp., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:245959-
A; 245960; 245961) Pesticide Data for Prairie Surface Waters from Environment
Canada (November 6, 1997).
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Appendix E. Batching of Triallate 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 station of products containing an active ingredient, the Agency generally batches
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 is 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.
For the active ingredient triallate, end-use product batching to meet the acute toxicity requirements was
not considered necessary, due to the nature of the registered end-use products.
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Appendix F. 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
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled
out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail 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
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
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
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)
tittD: //www. eDa.gov/ODDrd001/forms/8570-l.pdf
titto: //www. eDa.aov/ODDrdOOl /forms/85 70-4. Ddf
tittoV/www. eDa.gov/ODDrd001/forms/8570-5.Ddf
tittD://www. eDa.gov/ODDrd001/forms/8570- 17. Ddf
tittD: //www. eDa.gov/ODDrd001/forms/8570-25.pdf
tittD://www. eDa.gov/ODDrd001/forms/8570-27.Ddf
tittD: //www. eDa.gov/ODDrd001/forms/8570-28.pdf
tittD: //www. eDa.gov/ODDrd001/forms/8570-30.pdf
tittD://www. eDa.gov/ODDrd001/forms/8570-32.Ddf
tittD: //www. eDa.gov/ODDDmsdl /PR Notices/Dr98-5.Ddf
tittD://www. eDa.gov/ODDDmsdl /PR Notices/Dr98-5.Ddf
tittD://www. eDa.gov/ODDDmsdl /PR Notices/Dr98-l.Ddf
tittD://www. eDa.gov/ODDDmsdl /PR Notices/Dr98-l.Ddf
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following pertinent
forms and information needed to register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
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:
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Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service
(NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program
resulting from the passage of the FQPA and the reorganization of the Office of Pesticide
Programs. We anticipate that this publication will become available during the Fall of
1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge a
fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765)
494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN
by telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the 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
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trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been assigned.
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Appendix G. Generic Data Call-In
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78
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GDCIPagelof4
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GDCIPage2of4
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GDCIPage3of4
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GDCIPage4of4
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Appendix H. Product Specific Data Call-In
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84
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PDCIPage 1 of 4
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PDCIPage2of4
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PDCIPage3of4
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PDCIPage4of4
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Appendix I. List of All Registrants Sent This Data Call-In
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Page 1 of 1
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