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The Environmental Fate and Effects Division (EFED) and Antimicrobials Division (AD) have

completed the draft ecological risk assessment in support of the Registration Review of the
fungicide thiabendazole and the related salt, thiabendazole hypophosphite. The Antimicrobial
Division’s quantitative risk assessment for thiabendazole with respect to its antimicrobial uses is
attached as Appendix H.

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Draft Ecological Risk Assessment for the
Registration Review of Thiabendazole and
Thiabendazole Hypophosphite

Thiabendazole Thiabendazole hypophosphite


CAS No 148‐79‐8 CAS No 28558‐32‐9
USEPA PC Code: 060101 USEPA PC Code: 060102

Prepared by:
Nicholas Mastrota, Ph.D., Wildlife Biologist Diana Hsieh, Biologist
Jessica L. O. Joyce, M.S., Physical Scientist Kathryn Korthauer, Biologist

Reviewed by:
Rosanna Louie‐Juzwiak, Risk Assessment Process Leader
Elizabeth Donovan, Senior Biologist

Approved by:
Dana Spatz, Branch Chief Laura Parsons, Associate Branch Chief
Environmental Risk Branch III Risk Assessment and Science Support Branch
Environmental Fate and Effects Division Antimicrobials Division

Office of Pesticide Programs


United States Environmental Protection Agency

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Table of Contents

1 Executive Summary ...................................................................................................... 1


1.1 Overview ................................................................................................................. 1
1.2 Risk Conclusions Summary ...................................................................................... 1
1.3 Environmental Fate and Exposure Summary .......................................................... 4
1.4 Ecological Effects Summary .................................................................................... 5
2 Introduction ................................................................................................................. 5
3 Problem Formulation Update ....................................................................................... 6
3.1 Mode of Action for Target Pests ............................................................................. 7
3.2 Label and Use Characterization .............................................................................. 8
3.2.1 Label Summary ............................................................................................ 8
3.2.2 Usage Summary ........................................................................................ 15
3.2.3 Label Uncertainties ................................................................................... 15
4 Residues of Concern ................................................................................................... 16
5 Environmental Fate Summary .................................................................................... 16
5.1 Transformation Products ...................................................................................... 19
6 Ecotoxicity Summary .................................................................................................. 19
6.1 Aquatic Toxicity ..................................................................................................... 19
6.2 Terrestrial Toxicity................................................................................................. 21
6.3 Incident Data ......................................................................................................... 25
7 Analysis Plan .............................................................................................................. 25
7.1 Overall Process ...................................................................................................... 25
7.2 Modeling ............................................................................................................... 26
8 Aquatic Organism Risk Assessment ............................................................................ 27
8.1 Aquatic Exposure Assessment ............................................................................... 27
8.1.1 Modeling ................................................................................................... 27
8.1.2 Aquatic Monitoring Data........................................................................... 28
8.2 Aquatic Organism Risk Characterization .............................................................. 28
8.2.1 Aquatic Vertebrates .................................................................................. 28
8.2.2 Aquatic Invertebrates................................................................................ 29
8.2.3 Aquatic Plants............................................................................................ 32
8.3 Thiabendazole Hypophosphite (Tree Injection Use) ............................................. 33
9 Terrestrial Vertebrates Risk Assessment .................................................................... 33
9.1 Terrestrial Vertebrate Risk Characterization ........................................................ 33
9.1.1 Acute Risk .................................................................................................. 33
9.1.2 Chronic Risk ............................................................................................... 34
9.2 Thiabendazole Hypophosphite (Tree Injection Use) ............................................. 40
10 Terrestrial Invertebrate Risk Assessment ................................................................... 40
10.1 Terrestrial Invertebrate Pollinators, Tier I Exposure Estimates ............................ 40
10.2 Terrestrial Invertebrates, Non‐Pollinators ............................................................ 42
i
10.3 Thiabendazole Hypophosphite (Tree Injection Use) ............................................. 42
11 Terrestrial Plant Risk Assessment ............................................................................... 42
12 Conclusions ................................................................................................................ 43
13 Literature Cited .......................................................................................................... 44
14 Referenced MRIDs ..................................................................................................... 48
APPENDIX A. ROCKS Table ..................................................................................................... 64
APPENDIX B. Aquatic Modeling Input and Output ................................................................. 65
APPENDIX C. Example Model Output for Terrestrial Invertebrates (BeeREX Model) .............. 71
APPENDIX D. Endocrine Disruptor Screening Program (EDSP)................................................ 73
APPENDIX E. Listed Species ................................................................................................... 74
APPENDIX F. Calculated Application Rates............................................................................. 75
APPENDIX G. Analysis to Characterize Chronic Risk to Seed‐Eating Birds and Mammals ........ 76
APPENDIX H. Antimicrobial Uses Quantitative Draft Risk Assessment for Thiabendazole ...... 83
APPENDIX I. How to Use EFAST.............................................................................................. 92

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1 Executive Summary

1.1 Overview

This Draft Risk Assessment (DRA) examines the potential ecological risks associated with
registered uses of the fungicides thiabendazole and thiabendazole hypophosphite to animals
and plants. This assessment evaluates risks from outdoor uses of thiabendazole as a seed
treatment and as a treatment of roots, bulbs, tubers, and corms that are planted outdoors.
Ecological risk associated with the use of spent mushroom compost that is produced as a
byproduct of mushroom production, or from post‐harvest commodity treatment uses is
assessed qualitatively.

Thiabendazole hypophosphite is only used as an active ingredient in tree injection products to


protect trees from certain fungal diseases. Given the limited potential ecological exposure, and
per OPP guidance (USEPA 2018), ecological risk from the tree injection use was assessed
qualitatively.

The risk assessment focuses on the taxa of primary risk concern based on previously completed
risk assessments (USEPA 2016a, 2014d, 2010c, 2006), and for taxa for which additional data
have become available. Taxa of focus in this assessment are seed‐eating birds and mammals
and terrestrial invertebrates, particularly bees. Birds and mammals are a focus because of
chronic risk concerns and because of advancements of risk assessment methodology. Risk
assessments were completed for terrestrial invertebrates and updated for aquatic non‐vascular
plants because new toxicity data were submitted. For other taxa, the low risk conclusions of
previous risk assessments for conventional uses were confirmed.

The ecological risks associated with registered antimicrobial uses of thiabendazole are detailed
in Appendix H. Thiabendazole is registered as a material preservative and antifungal agent to
inhibit the growth of mold and mildew associated with odors, staining, discoloration, and
general biodeterioration on adhesive films, wallpaper adhesives, paints, stains, paper products,
plastics, rubber, and natural and synthetic fibers. The risk assessment performed for these
antimicrobial uses of thiabendazole focused on risks to aquatic organisms.

1.2 Risk Conclusions Summary

Ecological risk conclusions for conventional uses of thiabendazole are summarized in Table 1‐1.
Given the low application rates and lack of spray drift exposure associated with seed and seed
piece treatments (including corm, root, and tuber/bulbs), together with the low acute toxicity
levels and moderate mobility, RQs for ecological risks of agricultural uses of thiabendazole are

1
generally below LOCs. Consistent with previous risk assessments, all registered conventional
uses of thiabendazole are predicted to pose low acute and chronic risk to fish, aquatic
invertebrates, aquatic stages of amphibians, aquatic plants, terrestrial invertebrates, and
terrestrial plants.

Risks to terrestrial vertebrates (birds, mammals, reptiles, and terrestrial phases of amphibians)
are also expected to be low except for those animals that feed directly on treated seeds. Birds
and mammals that feed primarily on thiabendazole‐treated seeds in fields could potentially be
at risk because of sublethal effects (impaired growth and/or reproduction). Reptiles and
amphibians are not expected to be at risk because they generally do not feed extensively on
seeds. Lizards, frogs, and toads are generally predators that feed on invertebrates. Turtles can
be omnivorous but mainly graze on soft plant parts rather than seeds. Because the two
available avian reproductive studies failed to test high enough to determine a definitive LOAEC,
chronic risk to seed‐eating birds is uncertain and cannot be ruled out except for use on radish
and soybean seeds, for which the RQs are known to be below the LOC.

Chronic risk to seed eating mammals is somewhat more certain than for birds. RQs indicate
chronic risk for all seed treatment uses (RQs 2.3 to 44.2). Additional risk characterization
analysis done in this assessment neither confirmed nor refuted the potential chronic risk to
birds and mammals, but it did help to differentiate relative risk among different uses. An
analysis to estimate the area that an animal would need to forage to reach a toxicity threshold
found that the seed treatment uses posing the greatest potential exposure to birds and
mammals are alfalfa, carrot, onion, and small grains such as wheat and oat. A time‐based
analysis found that the seed treatment uses posing the greatest chronic risk to birds are
cucumber, melons, spinach, , squash, and small grains such as wheat and oat. The risk would be
low, however, for vegetable crops when the seeds are started indoors and then transplanted
into the field as seedlings. Potential effects to nontarget animals that consume thiabendazole
used to protect potato pieces and ornamental bulbs/tubers is likely limited to fossorial
(burrowing) mammals such as gophers.

Use of thiabendazole in mushroom production and post‐harvest commodity applications, and


use of thiabendazole hypophosphite as a tree injection treatment in ornamental trees, were
not modeled because there is a high level of uncertainty and assumptions that would be made
in attempting to estimate potential ecological exposures resulting from these uses. However,
because of the very limited spatial scale of these uses, any resulting ecological exposure and
potential risk would be very localized.

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Table 1‐1. Summary of Risk Quotients for Taxonomic Groups from Current Uses of
Thiabendazole
RQ Exceeding the
Exposure Risk Quotient Additional Information/
Taxa LOC for Non‐Listed
Duration (RQ) Range1 Lines of Evidence
Species
Acute <0.01 No ‐‐
Freshwater fish
Chronic <0.01 No ‐‐
Estuarine/ Acute <0.01 No ‐‐
marine fish Chronic <0.01 No ‐‐

Freshwater Acute <0.01 No ‐‐


invertebrates Chronic 0.01‐0.02 No ‐‐
Estuarine/ Acute <0.01 No ‐‐
marine
invertebrates Chronic 0.01 No ‐‐
Acute 0.01 No ‐‐
Mammals are at risk of possible chronic effects
(growth) when they feed primarily on treated
seeds. Risk is low to mammals that do not eat
seeds. Risk varies from crop to crop based on
Mammals seed treatment rate, seed planting rate, and
Chronic 2.1‐44.2 Yes seed size. RQs exceeded the LOC for all assessed
crops except radish and soybean. Risk is low
when seeds are started indoors and then
transplanted to the field. Exposure would be
reduced when seeds are planted with a precision
planter.
Acute 0.01 No ‐‐
No adverse effects were observed in avian
reproduction tests, but the study did not test to
Birds Yes
high enough exposure levels to determine if
Chronic 0.55‐11.5 (See additional
expected exposure levels could result in
information)
sublethal effects in seed‐eating birds. Risk to
birds that do not eat seeds is low.
Acute Adult <0.07 No ‐‐

Terrestrial Chronic Adult <LOC No


invertebrates ‐‐
Acute Larval <0.01 No
Chronic Larval <0.13 No
Aquatic plants N/A <0.01 No ‐‐
Terrestrial
N/A <0.1 No ‐‐
plants
1
Level of Concern (LOC) Definitions: Terrestrial Animals, Acute=0.5; Terrestrial Animals, Chronic=1.0; Terrestrial
invertebrates=0.4; Aquatic Animals, Acute=0.5; Aquatic Animals, Chronic=1.0; Plants: 1.0
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For antimicrobial uses, a screening level down‐the‐drain assessment of thiabendazole used in
pulp and paper mills was performed (Appendices H and I). Although in‐service use of consumer
products containing thiabendazole as a material preservative (i.e., paints, textiles, plastics, etc.)
may leach throughout their lifecycles, these environmental exposures are expected to be
minimal when compared to the use of thiabendazole in pulp and paper production which may
result in direct discharge of thiabendazole into waste streams. The evaluation of thiabendazole
used in pulp and paper mills indicated that freshwater fish and invertebrate acute
concentrations of concern (COCs) are exceeded 38‐291 days per year at the maximum labeled
concentration of 1250 ppm a.i.(EPA Reg No. 42750‐227), and 0‐10 days per year for at the
lower concentrations of 50 ppm a.i.(EPA Reg No. 42750‐227). Similarly, chronic COCs are
exceeded 73‐353 days per year with the maximum application rate but are reduced to 2‐74
days per year with the low rate. COCs for aquatic plants are exceeded for 3‐51 days at the
maximum labeled application rate, but not exceeded at the low application rate. Potential risks
to the aquatic receptor groups cannot be ruled out for any day in which COCs are exceeded for
the pulp and paper mill use pattern.

1.3 Environmental Fate and Exposure Summary

The residue of concern in this assessment is thiabendazole. Thiabendazole is a systemic,


generally persistent1, and slightly mobile2 fungicide. In soil, thiabendazole is persistent. In
aquatic environments, thiabendazole is considered stable to hydrolysis but degrades quickly by
photolysis. The route of aquatic exposure for thiabendazole is transfer of the compound from
seeds to soil, followed by transport to water. Extraction from seed coats of thiabendazole‐
treated seeds will be limited by the compound's high sorption, and any extracted compound
will likely bind strongly to soil. Transport to surface water would then occur primarily through
movement of entrained sediments. In surface water, thiabendazole is unlikely to persist,
especially in shallow and clear water because of the rapid aquatic photolysis, though it has
been detected in surface water monitoring samples.

Thiabendazole is not expected to degrade or sorb during wastewater treatment; therefore,


antimicrobial uses of thiabendazole that result in down‐the‐drain exposure to wastewater
treatment plants are assumed to result in 100% release of thiabendazole. More information
may be found in Appendix H.

1
Goring et al., 1975 persistence scale
2
Food and Agriculture Organization of the United Nations (FAO) mobility scale
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1.4 Ecological Effects Summary

Thiabendazole is highly acutely toxic to freshwater fish, freshwater invertebrates, and saltwater
invertebrates, but no more than slightly toxic to saltwater fish. On a chronic basis, aquatic
invertebrates are the most sensitive taxa. The NOAEC for the water flea (Daphnia magna) is
0.042 mg a.i./L, which is 7.4 times lower than the LC50. The acute‐to‐chronic ratio method was
used to estimate the NOAEC for saltwater invertebrates at 0.046 mg a.i./L. Chronic testing with
the fathead minnow (Pimephales promelas) indicates that fish are less sensitive, with a NOAEC
of 0.11 mg a.i./L. Thiabendazole has relatively low toxicity to aquatic plants and algae. The most
sensitive species is the cyanobacterium Anabaena flos‐aquae that has an IC50 of 1.4 mg a.i./L.

For terrestrial organisms, thiabendazole is classified as practically nontoxic to birds, mammals,


and bees on an acute exposure basis. With chronic exposure, thiabendazole can decrease
growth and food consumption in mammals at a dietary exposure level of 30 mg a.i./kg‐bw per
day, with a NOAEL established at 10 mg a.i./kg‐bw per day, which is equivalent to an NOAEC of
approximately 200 mg a.i./kg‐diet. Chronic toxicity testing with birds did not find any
observable chronic effects at dietary concentrations up to 400 mg a.i./kg diet.

Thiabendazole has low toxicity to terrestrial plants. In seedling emergence and vegetative vigor
studies, less than 25% inhibition was observed at 0.23 lb a.i./A, an exposure rate that is greater
than the allowable maximum application rate (0.15 lb a.i./A).

New honeybee data indicates that thiabendazole has low toxicity to the honey bee. No
significant mortality or sublethal effects were observed in acute tests with adult and larval
honey bees. Acute contact toxicity is classified as practically nontoxic. Likewise, no significant
mortality or sublethal effects were observed at any of the test levels. The highest test levels
were near or above the maximum concentrations that could occur in nature because of the
aqueous solubility of thiabendazole.

The ecotoxicological database for thiabendazole is complete with the exception of avian
reproductive toxicity. Available avian reproduction studies were inadequate for a complete risk
assessment because they did not test to high enough dietary concentrations, relative to
predicted environmental concentrations, to determine if there is chronic risk for the high
exposure levels predicted for birds that feed on treated seeds.

2 Introduction

This DRA examines the potential ecological risks associated with labeled uses of the fungicide
thiabendazole (PC Code 060101) and the related salt, thiabendazole hypophosphite (PC Code
060102) on non‐listed non‐target organisms. This document summarizes the best available
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information on the use, environmental fate, and ecotoxicity of these pesticide active
ingredients, and assesses the ecological risks associated with use of fungicide products
registered in the United States that contain these active ingredients. The general risk
assessment methodology used in this assessment is described in the Overview of the Ecological
Risk Assessment Process in the Office of Pesticide Programs (“Overview Document”) (USEPA,
2004). Methodology used for the risk assessment of the seed treatment uses of thiabendazole
is further described in Refinements for Risk Assessment of Pesticide Treated Seeds – Interim
Guidance (USEPA, 2016d). Federally listed threatened/endangered species (“listed”) are not
evaluated in this document. For additional information on listed species see Appendix E.

3 Problem Formulation Update

The Environmental Fate and Effects Division (EFED) and the Antimicrobials Division (AD)
completed a joint problem formulation for thiabendazole and thiabendazole hypophosphite in
March 2014 (USEPA, 2014a) (EPA Docket EPA‐HQ‐OPP‐2014‐0175). The problem formulation
provides the foundation for the environmental fate and ecological risk assessment being
conducted for the Registration Review process. It identifies the objectives for the risk
assessment and provides a plan for analyzing the data and characterizing the risk.

The problem formulation identified general pathways for potential aquatic exposure of
thiabendazole to nontarget organisms. Thiabendazole‐treated seeds may be a source of soil
contamination when the seeds are planted. In the terrestrial environment, the primary route of
exposure to terrestrial animals is expected to be from direct consumption of treated seeds.
Additional exposure may occur from absorption or ingestion of residues in soil. Aquatic
environments could be exposed by the transport of residues in runoff from fields planted with
treated seeds.

The original problem formulation identified two other possible routes of environmental
exposure from thiabendazole in spent mushroom culture (SMC) substrate used outdoors as a
soil amendment, and of use thiabendazole hypophosphite salt for tree injection applications to
protect ornamental trees. With the very limited spatial extent of the use of tree injection
products and SMC, these routes are expected to contribute little to the overall environmental
exposure to thiabendazole. Furthermore, confidence in any quantitative risk assessment for
these uses would be very low because of the high uncertainty associated with the available
exposure assessment methods that do not well represent these types of applications.
Therefore, these exposures were not estimated (USEPA, 2018), and ecological risks from these
uses will only be assessed qualitatively.

In the terrestrial environment, the primary route of exposure of thiabendazole to terrestrial


animals is expected to be from direct consumption of treated seeds. Additional exposure may
occur from absorption or ingestion of residues in soil.
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EFED requested an Environmental Chemistry Method (ECM) and Independent Laboratory
Validation (ILV) for water (GLN 850.6100). The ECM/ILV has been submitted. In addition, EFED
reviewed new data that were submitted subsequent to the Problem Formulation:
 Acute oral toxicity to a passerine bird (GLN 850.2100)
 Toxicity to a freshwater and saltwater diatom (GLN 850.4500)
 Toxicity to cyanobacteria (GLN 850.4550)

An acute dietary toxicity study with the canary (MRID 50103004) was classified as Acceptable. It
shows that, as with other avian taxa, thiabendazole is classified as practically nontoxic to
passerine birds on an acute toxicity basis. Acceptable data on the toxicity to freshwater and
marine diatoms were provided by two aquatic plant toxicity studies (MRID 49928201 and
49928203, D435332). A third toxicity study provided acceptable data on toxicity to
cyanobacteria (MRID 49928202, D435333). These studies show that the cyanobacteria are the
most sensitive type of nonvascular aquatic plant to thiabendazole. Because the toxicity
endpoint for cyanobacteria (EC50 = 1.42 mg a.i./L) is lower than that previously available for
nonvascular plants based on data for green algae (EC50 = 3.06 mg a.i./L), an updated risk
assessment for these plants is included in this document.

3.1 Mode of Action for Target Pests

Thiabendazole is a systemic fungicide in the benzimidazole fungicide class3. Other major


fungicides in this class include benomyl and carbendazim. Because the structure contains a
thiazole ring, thiabendazole can also be classified in the thiazole chemical class. The mode of
action of thiabendazole inhibits the mitosis of plant‐pathogenic fungi species by preventing the
polymerization of beta‐tubulins. Because dimers of beta‐tubulin and alpha‐tubulin polymerize
to form microtubule structures inside the cells, thiabendazole acts as an inhibitor of
microtubuline polymerization, terminating cell division. The Fungicide Resistance Action
Committee (FRAC) classifies thiabendazole in the B1 class (inhibitor of β‐tubulin assembly in
mitosis).

3
Alan Wood’s Compendium of Pesticide Common Names,
http://www.alanwood.net/pesticides/class_fungicides.html
7
3.2 Label and Use Characterization

3.2.1 Label Summary

Thiabendazole

Thiabendazole is used to control fungal diseases in agricultural crops and to control fungal
growth in/on various agricultural commodities, textiles, and manufactured materials. Of
greatest relevance for ecological risk are the uses as seed and seed piece treatments to protect
seeds of agricultural crops and ornamentals, uses to protect bulbs, tubers, corms, and seed
pieces from fungal disease, post‐harvest applications to non‐stored and stored commodities,
and uses to control fungal diseases in mushroom production. Use information and label
restrictions of uses are provided in Table 3‐1a and b.

As a seed treatment to prevent fungal diseases, thiabendazole is applied to seeds of a wide


variety of beans/peas, forage crops, grains, and vegetables (Table 3‐1). Thiabendazole seed
treatment products are formulated as flowable concentrate that is sprayed onto the seed. For
all crops, seeds may be treated with thiabendazole using equipment at the farm. Seeds of corn,
wheat, soybeans, beans, and peas also may be treated commercially prior to purchase by the
farmer. Thiabendazole is also used to treat seed pieces of potato and other root vegetables,
sweet potato “seed roots” (root pieces used to grow slips), and bulbs and corms of ornamental
plants. The labels of many products restrict the application rate of thiabendazole as seed
treatment to a maximum annual rate of 0.15 lb a.i./A. Some products currently do not have this
restriction or list a maximum annual application rate. However, in correspondence from one of
the technical registrants, Syngenta, they proposed to add the following language to product
labels: “do not apply more than 0.15 lb a.i./A (68 g a.i./A) per year.” As such, exposure
modeling in this assessment is based on a total annual rate of up to, or less than 0.15 lb a.i./A.

Thiabendazole may be broadcast via mechanically pressured hand sprayer onto mushrooms at
the casing, fuzzing, pinning stages, and between harvests of mushroom breaks. Thiabendazole
may be applied to mushrooms at maximum rates ranging from 4 to 8 fl. oz./1,000 ft2 (EPA Reg
Nos. 42750‐226, 100‐889). Although application of thiabendazole in mushroom culture takes
place indoors, after the mushrooms are harvested, the spent mushroom substrate on which
thiabendazole was sprayed, may be utilized as a soil amendment outdoors.

Post‐harvest uses of thiabendazole include applications to non‐stored and stored commodities,


including citrus, pome fruit (apple, pear), root and corm vegetables (potato including sweet,
carrot), tropical fruits including banana, plantain, mango, and papaya, and sugar beet.
Application methods include a dip/wash (water, wax and/or oil), thermal fogger, and drench.

8
Target concentrations are variable depending on the specific fruit or vegetable receiving the
application; labeled concentrations can range from 200 to 5,000 ppm in solution.

Thiabendazole is used as an antimicrobial pesticide as a material preservative and antifungal


agent to inhibit the growth of mold and mildew associated with odors, staining, discoloration,
and general biodeterioration on adhesive films, wallpaper adhesives, interior and exterior latex
or solvent/oil based paint films, stains, paper products, heating and cooling system filters
and/or room air cleaners/purifiers, wallboard, sealants, grout, ceiling tiles, plastics, plastic
intermediates, flexible PVC systems, polymeric products, cellulosic sponges, rubber, canvas
textiles, and carpet backing, and natural and synthetic fibers. More information regarding
antimicrobial uses may be found in Appendix H.

Thiabendazole hypophosphite

Thiabendazole hypophosphite, a salt of thiabendazole, is used as a tree injection fungicide for


control of certain fungal diseases in elms, London plane, oak, and sycamore trees. Products
containing thiabendazole hypophosphite are formulated as a soluble concentrate or a ready‐to‐
use solution. They are applied by injection into sapwood of root flares of the tree. Application
information for thiabendazole hypophosphite are summarized in Table 3‐3. The maximum
application rate for large trees >30 inches in diameter of breast height (DBH) is 0.169 lb a.i. per
5 inches of trunk diameter. For trees less than 30 inches in DBH, the maximum application rate
is 0.113 lb of active ingredient per 5 inch of trunk diameter. The rates in terms of thiabendazole
equivalence are 0.127 lb thiabendazole per 5 inches of diameter for large trees and 0.0850 lb
thiabendazole per 5 inches of diameter. Trees may be retreated once every three years.

9
Table 3‐1.a. Summary of the Maximum Labeled Use Patterns for Thiabendazole when Rates Are Expressed as Amount per
Hundred Pounds of Seed
Comments (e.g.
Maximum Seed Max App
Use Site/ App App geographic/application timing
Form1 Treatment Rate Rate2 MRI (d) PHI (d)
Location Type Equip restrictions, pollinator specific
(lb a.i./100 lb seed) (lbs ai/A)
language)

Seed Treatments

Seed Seed treatment,


Alfalfa FlC 0.186 0.15 NA NS 100‐889
Treatment on farm
Seed Seed treatment,
Barley FlC 0.0183 0.15 NA NS 100‐889
Treatment on farm
Brassica (Head
Seed Seed treatment,
and Stem FlC 0.112 NS NA NS OR100014
Treatment on farm
Vegetables)
Seed Seed treatment,
Clover FlC 0.279 NS NA NS OR100014
Treatment on farm
Seed Seed treatment,
Corn, Field FlC 0.279 NS NA NS OR100014
Treatment on farm
Seed Seed treatment, 30 100‐1629
Corn, Field FlC 0.0201 NS NA
Treatment on farm (forage) Disallowed in CA
Seed Seed treatment, 30 100‐1629
Corn, Pop FlC 0.0451 NS NA
Treatment on farm (forage) Disallowed in CA
Seed Seed treatment, 30 100‐1629
Corn, Sweet FlC 0.0351 NS NA
Treatment on farm (forage) Disallowed in CA
Garbanzo Seed Seed treatment,
FlC 0.0653 0.15 NA NS 100‐889
Bean/Chickpea Treatment on farm
Seed Seed treatment,
Lentil FlC 0.0328 0.15 NA NS 42750‐226
Treatment on farm
Legume
Seed Seed treatment,
Vegetables, FlC 0.0538 0.15 NA NS 42750‐226
Treatment on farm
Group 8C

10
Comments (e.g.
Maximum Seed Max App
Use Site/ App App geographic/application timing
Form1 Treatment Rate Rate2 MRI (d) PHI (d)
Location Type Equip restrictions, pollinator specific
(lb a.i./100 lb seed) (lbs ai/A)
language)
Legume Seed treatment,
Seed
Vegetables, FlC commercial or 0.0152 NS NA NS 100‐1583
Treatment
Group 8C on farm
Seed Seed treatment,
Mustard FlC 0.112 NS NA NS OR100014
Treatment on farm
Seed Seed treatment,
Oat FlC 0.109 0.15 NA NS 100‐889
Treatment on farm
Seed Seed treatment,
Pea FlC 0.0327 0.15 NA NS 100‐889
Treatment on farm
Radish,
Seed Seed treatment,
[Daikon and FlC 0.112 NS NA NS OR100014
Treatment on farm
Chinese]
Seed Seed treatment,
Rye FlC 0.103 0.15 NA NS 100‐889
Treatment on farm
Seed Seed treatment, 100‐889
Soybean FlC 0.0205 0.15 NA NS
Treatment on farm Disallowed in CA
Seed Seed treatment,
Triticale FlC 0.0833 0.15 NA NS 100‐889
Treatment on farm
Commercially treated seed has a
lower maximum treatment rate of
Seed Seed treatment,
Wheat FlC 0.125 0.15 NA 31 0.00238 lb a.i./100 lb seed.
Treatment on farm
42750‐270, 100‐889
Disallowed in CA
Pre‐Plant Root and Tuber Treatments
Treatment is typically made prior
Ornamentals Bulb or
FlC Dip tank 0.00961 lb/gal NS NA NS to storage.
(Root or bulb) Corm Dip
100‐889, 42750‐226,43410‐33

11
Comments (e.g.
Maximum Seed Max App
Use Site/ App App geographic/application timing
Form1 Treatment Rate Rate2 MRI (d) PHI (d)
Location Type Equip restrictions, pollinator specific
(lb a.i./100 lb seed) (lbs ai/A)
language)
Conveyor
Treatment prior to storage
FlC Seed pieces application 0.0343 lb/lb tubers NS NA NS
100‐889, 42750‐226
Potato system
Treatment prior to shipment
FlC Seed pieces Dip tank 0.0343 lb/gal NS NA NS
100‐889, 42750‐226
Sweet Potato
Root pieces are planted
(Root pieces Seed Root
FlC Dip tank 0.0343 lb/gal NS NA NS immediately after treatment
used to Dip
100‐889, 42750‐226
produce slips)
1
FlC = flowable concentrate.
2
When listed, the maximum limit of 0.15 lb a.i./A is the maximum amount of thiabendazole from all sources that may be applied in one year.
* Information is provided on an annual basis, unless otherwise specified.

12
Table 3‐2.b. Summary of the Maximum Labeled Use Patterns for Thiabendazole when Rate is Expressed as Amount per Seed
Comments (e.g.
Maximum Seed Max Single geographic/application
Use Site/ App App
Form1 Treatment Rate Rate MRI (d) PHI (d) timing restrictions,
Location Type Equip
(mg a.i./seed) lbs ai/A pollinator specific
language)
Brassica (Head
Seed Seed treatment, 100‐889
and Stem FlC 0.002* 0.15 NA NS
Treatment on farm *4.4 x 10‐9 lb ai/seed
Vegetables)
Bulb Seed Seed treatment, 100‐889
FlC 0.002* 0.15 NA NS
Vegetables Treatment on farm *4.4 x 10‐9 lb ai/seed
Seed Seed treatment, 0.0726*
Corn, Field FlC 0.15 NA NS 42750‐226
Treatment on farm (0.41 fl oz/80000 seeds)
*1.6 x 10‐7 lb a.i./seed
Seed Seed treatment, 0.0726*
Corn, Sweet FlC 0.15 NA NS Label inaccurately equates
Treatment on farm (0.41 fl oz/80000 seeds)
0.41 fl oz/80,000 seeds to
Seed Seed treatment, 0.0726* 0.057 mg/seed
Corn, Pop FlC 0.15 NA NS
Treatment on farm (0.41 fl oz/80000 seeds)
Cucurbit Seed Seed treatment, 100‐889
FlC 0.10* 0.15 NA NS
Vegetables Treatment on farm *2.21 x 10‐7 lb a.i./seed
Root
Seed/
Vegetables Seed treatment, 100‐889
FlC Seed Pieces 0.002* 0.15 NA NS
(except sugar on farm *4.4 x 10‐9 lb ai/seed
Treatment
beet)
Seed Seed treatment, 100‐889
Spinach FlC 0.006* 0.15 NA NS
Treatment on farm *1.33 x 10‐8 lb ai/seed
1
FlC = flowable concentrate.
() Values in parenthesis were calculated based on other information provided on the label. These values are not on the label.
* Information is provided on an annual basis, unless otherwise specified.

13
Table 3‐3. Summary of the Maximum Labeled Use Patterns for Thiabendazole hypophosphite
Max Max
Max Comments (e.g.
Single Annual
Use Site/ App App App App # MRI geographic/application timing
Form1 Rate Rate PHI (d)
Location Target Type Equip Time App/ (d) restrictions, pollinator specific
lbs ai/5 in lbs
yr* language)
of DBH ai/A/yr*
Elm, Sycamore, London Plane,
>30 in
0.169 NS NS 3 years NA Oak, >30 in diameter
diameter
Deciduous/ 100‐892, 74779‐4
Hand Elm, Sycamore, London Plane,
Broadleaf/ <30 in
SC/L Tree Injection Injection 0.113 NS NS 3 years NA Oak, <30 in diameter
Hardwood diameter
Equipment 100‐892, 74779‐4
Tree
Any
0.0563 NS NS 1 year NA Elm, 1‐year treatment
stage
1
SC=soluble concentrate; L=liquid () Values in parenthesis were calculated based on other information provided on the label. These values are not on the label.

14
3.2.2 Usage Summary

BEAD provided a screening‐level usage analysis (SLUA, 2013), which covers the reporting
timeframe of 2004 through 2011. The SLUA only considers agricultural use and indicates that on
average less than 500 pounds of thiabendazole were applied as seed treatment to potatoes,
soybeans, and wheat per year, with an average percent crop treated of less than 1%, and a
maximum percent crop treated of less than 2.5%.

3.2.3 Label Uncertainties

The labels of some seed treatment products define the seed treatment rate as a weight a.i. per
weight seed rate (lb a.i./lb seed) but do not specify a maximum annual application rate. For
these products, the maximum rate per crop cycle was estimated by multiplying the maximum
seed treatment rate by the estimated seed planting rate (seeds/acre) for the specific crops.
Seed weights and minimum and maximum seed planting rates were provided by the Biological
and Economic Analysis Division (BEAD, USEPA, 2011).

Labels of other seed treatment products describe the seed treatment rates in terms of amount
of active ingredient applied per seed (mg a.i./seed) rather than per weight of seeds. Calculating
the application rate to the field will depend upon the seed weight as well as the seed planting
rate. Seed weights and seeding rates can vary considerably for different varieties of a crop and
for crops within a crop group, and therefore the application rates for these products can vary
considerably. Most labels for these products restrict the maximum amount of a.i. that may be
applied to the field as the result of planting treated seeds to 0.15 lb a.i./A per year. When this
restriction exists, it was used to model the maximum possible application rate; however, typical
application rates could be much less. To better characterize exposure and risk, EFED also
calculated upper‐bound range of application rates for these products based on the maximum
amount of a.i. allowed per seed, the weight of a relatively small seed in that crop or crop group,
and the minimum and maximum expected seeding rates (APPENDIX F).

The product Maxim Quattro® (100‐1352) does not specify any maximum annual application
rate for use on corn. The maximum seed treatment rate is specified as 0.53 fl oz product per
seed, which is equivalent to 1.29 x 10‐7 lb a.i./A. A range of application rates for this use were
calculated by multiplying this per‐seed rate by the minimum and maximum number of seeds
expected to be planted per acre.

15
4 Residues of Concern

In this risk assessment, stressors are those chemicals that may exert adverse effects on non‐
target organisms. Collectively, the stressors of concern are termed the Residue(s) of Concern
(ROC). The ROC for this assessment is only thiabendazole because of how generally stable this
compound is in the environment. Other than aqueous photolysis, the subsequent formation of
degradation products is slow, and the field dissipation studies detected no products of
thiabendazole. In shallow and clear water, thiabendazole will degrade based on the rapid
aquatic photolysis half‐life, but in all other aquatic environments it will likely persist. Exposure
to degradation products of thiabendazole is expected to be minimal.

Thiabendazole hypophosphate is a salt and completely dissociates in water. Therefore,


thiabendazole is the only ROC for this active ingredient.

5 Environmental Fate Summary

Apart from an environmental chemistry method, there have been no additional conventional
environmental fate data submitted since the previous assessment in 2014. Pertinent physical‐
chemical and environmental fate and transport properties of thiabendazole are summarized in
Table 5‐1, and Table 5‐2, respectively. Thiabendazole is a generally persistent and slightly
mobile fungicide. Vapor pressure and Henry’s Constant indicate that thiabendazole has a low
potential to volatilize from soil and water. Environmental fate studies indicate that
thiabendazole is persistent in all soil and aqueous studies except for aqueous photolysis.
Thiabendazole is stable to hydrolysis and soil photolysis and degrades slowly in aerobic (half‐life
~ 700 days) and anaerobic soil environments (>200 days). Under anaerobic aquatic conditions,
thiabendazole showed no evidence of abiotic or biotic degradation but moved rapidly from
water phase to the sediment phase. With a half‐life of 1.2 days, aquatic photolysis appears to
be the only significant degradation pathway. Thiabendazole binds tightly to soil due to its high
soil/water partitioning coefficients (Koc > 1,000 mL/goc), thus likely limiting the amount available
for leaching into groundwater and for solution phase runoff into surface water. Terrestrial field
dissipation studies also showed thiabendazole to be persistent with no observable leaching.

The route of aquatic exposure for thiabendazole is transfer of the compound from seeds to soil,
followed by transport to water. Extraction from seed coats of thiabendazole‐treated seeds will
be limited by the compound's high sorption capacity, and any extracted residue will likely bind
strongly to soil. Transport to surface water would then occur primarily through movement of
entrained sediments. In shallow and clear water, thiabendazole is not likely to persist because
of rapid aquatic photolysis, but in all other aquatic environments it may persist and has been
detected in surface water monitoring samples.

16
Table 5‐1. Summary of Physical‐Chemical, Sorption, and Bioconcentration Properties of
Thiabendazole
Source/
Parameter Value1 Study Classification/
Comment
Molecular Weight 201.1
EPA Substance Registry Service
(g/mole) [Thiabendazole hypophosphite: 267.25]
30, pH 5
Buffered Solution (25°C) 28, pH 7 40947301
28, pH 9
Water Solubility (mg/L) Water (No Temp
22.74 48354601
Provided)
79.82, pH 4
Buffered Solution (20°C) 22.77, pH 7 48354604
23.75, pH 10
48354601
3.45 x 10‐9
Non‐volatile under field conditions
Vapor Pressure (torr)
RED (2002)
4.0 x 10‐9
Non‐volatile under field conditions
Henry’s Law constant Estimated1 from vapor pressure and
3.26 x10‐11
at 25oC (atm‐m3/mole) water solubility at 25oC.
Log Dissociation pKa1 = 4.5 48354604
Constant (pKa) pKa2 = 12.01 40947302
Log Octanol‐water 48254601
partition coefficient 48354604
1.61 Not likely to bioconcentrate
(LogKow) at 16.6oC
(unitless) significantly.
Soil‐Water Distribution Soil/Sediment KF (mL/g) /
KOC
Coefficients (Kd in KFoc(mL/goc)
L/kg‐soil or sediment) Sand 2.49 / 1,104
Sandy loam 15.97 /3,992 41170102
Organic carbon Silt loam 21.75 / 1,812 Slightly Mobile
normalized Mean: 7,343 (FAO classification system)
distribution
Clay 269.6 / 22,467
coefficients (Koc in
mL/g‐organic carbon)
Species BCF Depuration 41631801
42022701
Fish bioconcentration 3 days
Low bioconcentration potential in
factors (steady state); 86.5 96% in viscera
‐‐ edible tissue, some potential to
depuration rate (whole fish) 50% in edible
bioaccumulate in viscera but with
tissue
rapid depuration
1
All estimated values were calculated according to “Guidance for Reporting on the Environmental Fate and
Transport of the Stressors of Concern in Problem Formulations for Registration Review, Registration Review Risk
Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and Other Relevant Risk
Assessments” (USEPA, 2010a).

17
Table 5‐2. Summary of Environmental Degradation Data for Thiabendazole

Representative Half‐ Source/ Study


Study System Details
life (days)1,2 Classification/Comment

41265301
(D245780; 02/04/99)
Abiotic Ratesa of transformation were
pH 5, 7, 9 Stable
Hydrolysis extrapolated resulting in t½ (198 days
@pH 7) far beyond the length of the
study (30 days)
Aqueous pH 5, (22.5 to 23.2
o 1.2 43328305
Photolysis C) 40oN sunlight
25oC, pH 7 41297301
Soil Photolysis Stable
40oN sunlight 41397302
41791201
Aerobic Soil
25oC 688 Registration Document D245780
Metabolism
One soil
41559601
Anaerobic Soil Degradate
25oC 211
Metabolism benzimidazole detected
(max 13.7 % AR;).

Aerobic Aquatic (D169687; 12/30/92)


Study requirement waived
Metabolism 41559601

00122888
Anaerobic
00070753
Aquatic ‐‐‐ Stable
Rapidly moved from water phase to
Metabolism
the sediment phase.

A summary of terrestrial field dissipation data is provided in Table 5‐3. Dissipation half‐lives in
reviewed terrestrial field dissipation studies ranged from 833 to 1,444 days at 3 sites in the
United States. Overall, these results are consistent with the persistence predicted by the
laboratory studies and indicate that thiabendazole is persistent in all tested sites, regardless of
crop or bare soil. Thiabendazole remained in the top 12 inches of soil.

Table 5‐3. Summary of Field Dissipation Data for Thiabendazole


Maximum Leaching
System Details DT50 (days) Source
Depth (in)
WA, Loam, Winter
1,100 6 MRID 43187201
Wheat
IL, Sandy Loam,
990
Soybean 12 MRID 43187202
1,444
and Bare Ground

18
Maximum Leaching
System Details DT50 (days) Source
Depth (in)
GA, Sandy Loam,
833
Soybean 6 MRID 43187201
1,093
and Bare Ground

5.1 Transformation Products

Two major degradates: benzimidazole‐2‐carboxamide and benzimidazole were observed in an


aqueous photolysis study and in an anaerobic soil metabolism study, respectively.
Benzimidazole was analyzed in addition to thiabendazole in the field dissipation studies but was
not detected. While photodegradation resulted in the formation of benzimidazole‐2‐
carboxamide, the dissipation of thiabendazole is expected to be dependent on water condition
(e.g., sediment loading, depth, etc.) affecting sunlight penetration. For example, thiabendazole
should not persist in clear shallow water bodies, but will be more persistent in turbid and/or
deeper waters, particularly those with long hydrological residence times.

Minor transformation products include benzimidazole‐2‐carboxylic acid, which was observed in


an aqueous photolysis study, and 5‐hydroxythiabendazole and carbon dioxide, which were
observed in the aerobic soil metabolism studies.

6 Ecotoxicity Summary

This section summarizes available ecotoxicity data on the effects of thiabendazole to non‐target
animals and plants. Most of these data have been previously presented in earlier risk
assessments and in the Problem Formulation (USEPA 2014). Since the problem formulation,
new toxicity data have been submitted for acute bird toxicity, honeybees, certain nonvascular
aquatic plants, and cyanobacteria. Values that are based on newly submitted data are
designated in the tables with an N superscript.

6.1 Aquatic Toxicity

Toxicity tests of thiabendazole to aquatic organisms are summarized in Table 6‐1. The available
data indicate that thiabendazole is highly toxic to freshwater fish, based on a study with the
rainbow trout (Oncorhynchus mykiss), but no more than slightly toxic to saltwater fish on an
acute exposure basis. Thiabendazole is highly toxic to freshwater and saltwater invertebrates
on an acute exposure basis. Lifecycle testing with the waterflea (Daphnia magna) yielded the
most sensitive chronic endpoint, with adverse effects on survival and reproduction observed at
concentrations of 0.087 mg a.i./L and above. No data are available on the toxicity of
19
thiabendazole to sediment‐dwelling invertebrates. For aquatic plants, EC50 values are as low as
2.32 mg a.i./L for vascular plants and 1.42 mg a.i./L for nonvascular plants. The most sensitive
species was the cyanobacteria Anabaena flos‐aquae.

Table 6‐1. Aquatic Toxicity Endpoints Selected for Risk Estimation for Thiabendazole
Test MRID or ECOTOX
Study Toxicity Value
Substance Test Species No./ Comments
Type (mg a.i./L)
(% a.i.) Classification
Freshwater Fish (surrogates for aquatic vertebrates)
Acute toxicity is classified
as Highly Toxic. A study
Rainbow Trout
TGAI 41025005 with the bluegill found it to
Acute (Oncorhynchus 96‐h LC50 = 0.56
(99.6%) Acceptable be a much less sensitive
mykiss)
species (LC50 = 19 mg a.i./L,
MRID 424777‐01).
Fathead minnow 33‐day The LOAEC was based on a
TGAI 42508901
Chronic (Pimephales NOAEC = 0.11 25% reduction in body wet
(98.5%) Acceptable
promelas) LOAEC = 0.23 weight.
Estuarine/marine Fish (Surrogates for aquatic vertebrates)
Sheepshead
The acute toxicity level for
Minnow 41192003
Acute TGAI 96‐h LC50 > 10 saltwater fish is no more
(Cyprinodon Acceptable
(99.6%) than slightly toxic.
variegatus)
No estimation of chronic
toxicity to saltwater fish is
available. Acute‐to‐chronic
estimate could not be
Chronic ‐‐ ‐‐ ‐‐ ‐‐
calculated because the
acute and chronic
freshwater fish test species
were different.
Freshwater Invertebrates
TGAI Water Flea 00123326 Acute toxicity is classified
Acute 48‐h LC50 = 0.31
(99.8%) (Daphnia magna) Acceptable as Highly Toxic.
The LOAEC was based on a
21‐day
TGAI 00094645 33% reduction in survival
Chronic Water Flea NOAEC = 0.042
(98.5%) Acceptable and 83% reduction in
LOAEC = 0.087
offspring production
Estuarine/ marine invertebrates
Mysid
TGAI 41192002 Acute toxicity is classified
Acute (Americamysis 96‐h LC50 = 0.34
(99.6%) Acceptable as Highly Toxic.
bahia)

20
Test MRID or ECOTOX
Study Toxicity Value
Substance Test Species No./ Comments
Type (mg a.i./L)
(% a.i.) Classification
NOAEC = 0.046
Mysid Acute‐to‐chronic ratio of
(estimated by the
Chronic (Americamysis 7.38 based on the toxicity
acute to chronic
bahia) data for the waterflea.1
ratio)
Aquatic plants and algae
The LOAEC was based on a
20% reduction of frond
7‐day EC50 = 2.32 number. The study was
TGAI Duckweed 48996308
Vascular NOAEC = 0.26 supplemental because the
(99.5%) (Lemna gibba) Supplemental
LOAEC = 0.70 study design used only
three replicates per
treatment level.
Cyanobacteria, 96‐hr EC50 = 1.42 The LOAEC was based on a
Non‐ TGAI 49928202N
(Anabaena flos- NOAEC = 0.39 43% reduction in cell
vascular (99.5%) Acceptable
aquae) LOAEC = 1.1 density
TGAI=Technical Grade Active Ingredient; TEP= Typical end‐use product; a.i.=active ingredient
N
Studies submitted since the problem formulation.
1
Acute‐to‐chronic ratio for the waterflea = 0.31/0.042 = 7.38. Estimated mysid NOAEC = 0.34/7.38 = 0.046.
>Greater than values designate non‐definitive endpoints where no effects were observed at the highest level
tested, or effects did not reach 50% at the highest concentration tested (USEPA, 2011).

6.2 Terrestrial Toxicity

Thiabendazole has low acute toxicity to terrestrial vertebrates. Acute oral and subacute dietary
tests classify thiabendazole as practically nontoxic to birds and mammals. There was one
possibly treatment‐related mortality reported at 3160 mg a.i./kg‐diet in a subacute dietary
study with the bobwhite (MRID 41025003). Otherwise, no mortality was reported in any of the
submitted acute/subacute avian or mammalian studies.

In tests with chronic exposure, the laboratory rat (Rattus norvegicus) was the most sensitive
wildlife test species. A dietary concentration of 30 mg a.i./kg‐bw per day resulted in significant
reductions in food consumption and body weight gain in a two‐generational reproduction
study. Developmental effects were observed at 90 mg a.i./kg‐bw per day. This study set the
chronic mammal NOAEL at 10 mg a.i./kg‐bw per day, which is approximately equivalent to a
dietary concentration of 200 mg a.i./kg‐diet. In reproductive toxicity studies on the northern
bobwhite (Colinus virginianus) and the mallard (Anas platyrhynchos), no adverse effects were
observed in birds exposed to diets up to 400 mg a.i./kg‐diet for 22 weeks.

Thiabendazole is classified as practically nontoxic to adult honey bees with acute contact
exposure. In acute and chronic oral tests, thiabendazole caused no observable toxic effects to
21
adult or larval honey bees when exposed to the maximum dietary concentrations that could be
achieved with the limited aqueous solubility. Although these tests did not yield definitive
toxicity endpoints, they do demonstrate that thiabendazole is nontoxic at the tested exposure
levels, and, predicted in this risk assessment.

For plants, seedling emergence and vegetative vigor limit tests are available in which seeds and
young plants, respectively, were exposed to a thiabendazole formulation with 42.6% a.i. at an
application rate of 0.23 lb a.i./A. This rate is higher than the maximum rate allowed (0.15 lb
a.i./A). At this rate, reduction in emergence/survival and inhibition of growth were less than
25% (i.e., IC25 > 0.23 lb a.i./A) for all ten test species). However, the reduction of emergence and
survival were statistically significant in one test species in the seedling emergence test, and the
inhibitions of shoot length were statistically significant in three test species in the vegetative
vigor test. Therefore, the NOAEL was < 0.23 lb a.i./A for these species.

Table 6‐2. Terrestrial Toxicity Endpoints Selected for Risk Estimation for Thiabendazole
Test MRID or
Study Type Substance Test Species Toxicity Value1 ECOTOX No./ Comments
(% a.i.) Classification
Birds (surrogates for terrestrial amphibians and reptiles)
Bobwhite
Acute oral toxicity is
TGAI quail LD50 > 2,250 mg 41025002
Acute Oral classified as Practically
(99.6%) (Colinus a.i./kg‐bw Acceptable
Nontoxic
virginianus)
Bobwhite
41025003 & Subacute dietary toxicity
TGAI quail and 5‐days LC50 > 5,620
41025004 is classified as Practically
(99.6%) mallard (Anas mg a.i./kg‐diet
Sub‐acute Acceptable Nontoxic
platyrhynchos)
dietary
Canary Subacute dietary toxicity
TGAI 5‐days LC50 > 5,298 50103004N
(Serinus is classified as Practically
(99.5%) mg a.i./kg‐diet Acceptable
canaria) Nontoxic
22‐weeks
Bobwhite 00123327 & No effects were observed
TGAI NOAEC ≥ 400
Chronic quail and 00123328 in birds fed 80 or 400 mg
(98.5%) LOAEC > 400
mallard Acceptable a.i./kg‐bw.
mg/kg‐diet
Mammals
14‐day LD50 =
Laboratory rat 5070 mg a.i./kg‐bw Acute oral toxicity is
TGAI 41258201
Acute Oral (Rattus (M) classified as Practically
(98.5%) Acceptable
norvegicus) 4734 mg a.i./kg‐bw Nontoxic
(F)

22
Test MRID or
Study Type Substance Test Species Toxicity Value1 ECOTOX No./ Comments
(% a.i.) Classification
The toxicity category for
Acute 4‐hr LD50 > 6.84 mg 00100706
TGAI Laboratory rat acute inhalation toxicity is
Inhalation a.i./L Guideline
II (Warning)
LOAEL is based on 10‐16%
decrease in body weight
gain and 3‐4% decrease in
food consumption of F0
NOAEL = 10 mg males, and 7‐18%
Chronic,
TGAI a.i./kg‐bw/day 43190301 decrease in body weight
2‐generation Laboratory rat
(>99%) LOAEL = 30 mg Acceptable gain and 4‐5% decrease in
reproduction
a.i./kg‐bw/day food consumption of F1
males. The developmental
effect of reduced mean
pup weight was observed
at 90 mg a.i./kg/day.
Terrestrial invertebrates
Acute Honey bee This was a limit test. No
TGAI 48‐hr LD50 > 34 µg 48996305
contact (Apis mellifera toxic effects were
(98.8%) a.i./bee Acceptable
(adult) L.) observed at the test dose.
This was a limit test. No
Acute oral TGAI 48‐hr LD50 > 4 µg 48996305
Honey bee toxic effects were
(adult) (98.8%) a.i./bee Acceptable
observed at the test dose.
This study is classified as
supplemental because of
an error in the
NOAEC ≥2.57 µg preparation of test
a.i./bee/day solutions on Day 5 and
LOAEC >2.57 µg other guideline
a.i./bee/day deviations. The results are
50103001N
Chronic oral considered suitable for
TGAI Honey bee Supplemental
(adult) LC50 >115.2 mg only qualitative use in risk
(98.8%)
a.i/kg diet assessment. Mortality was
no more than 6.7% at any
LD50 >2.57 mg treatment level and was
a.i/bee/day diet considered incidental. No
treatment‐related
sublethal effects were
observed.
LC50 >213 mg a.i./kg
50103002N
Acute oral TGAI diet No treatment‐related
Honey bee Acceptable
(larval) 99.5(%) LD50 >7.26 µg effects were observed.
a.i./larva

23
Test MRID or
Study Type Substance Test Species Toxicity Value1 ECOTOX No./ Comments
(% a.i.) Classification
NOAEC ≥ 25 mg
a.i./kg diet
LOAEC >25 mg
a.i./kg diet

NOAEL ≥ 0.98 µg
50103003N
Chronic oral TGAI a.i./bee/day No significant effects were
Honey bee Acceptable
(larval) (99.5%) LOAEL >0.98 µg observed.
a.i./bee/day

LC50 > 25 mg a.i/kg


diet
LD50 > 0.98 mg
a.i/bee/day diet
Terrestrial and wetland plants
Dicots (tomato and
soybean): This was a limit test with a
IC25 > 0.23 lb single test level of 0.23 lb
a.i./acre a.i./A. Significant
NOAEC < 0.23 lb inhibition of shoot length
a.i./acre was observed in tomato,
Vegetative TEP Various 48996307
soybean, and ryegrass
Vigor (42.6%) species Acceptable
Monocots (11%, 13%, and 9%,
(ryegrass): respectively). No
IC25 > 0.23 lb significant inhibition was
a.i./acre observed in the other 7
NOAEC < 0.23 lb test species.
a.i./acre
This was a limit test with a
single test level of 0.22‐
Dicots (cucumber): 0.23 lb a.i./A (depending
IC25 >0.23 lb on the species). Significant
a.i./acre; inhibition of emergence
NOAEC < 0.23 lb 48996306 and survival was observed
a.i./acre Acceptable, in cucumber (22% and
Seedling TEP Various except 22%, respectively). No
Emergence (42.6%) species Monocots (all Supplemental significant inhibition was
species): for bean and observed in the other 9
IC25 > 0.23 lb soybean test species. The study
a.i./acre; was classified as
NOAEC = 0.23 supplemental for bean
lb/acre and soybean because the
greenhouse temperatures
were excessively high.
24
TGAI=Technical Grade Active Ingredient; TEP= Typical end‐use product; a.i.=active ingredient
N
Studies submitted since the problem formulation was completed.
1
NOAEC and LOAEC are reported in the same units.
>Greater than values designate non‐definitive endpoints where no effects were observed at the highest level
tested, or effects did not reach 50% at the highest concentration tested (USEPA, 2011).
< Less than values designate non‐definitive endpoints where growth, reproductive, and/or mortality effects are
observed at the lowest tested concentration.

6.3 Incident Data

The Incident Data System (IDS) provides information on the available ecological pesticide
incidents. As of November 2018, four incidents were identified that were associated with
thiabendazole, among other pesticides. However, in each of these incidents, the observed
adverse effects were more likely because of exposure to one or more of the other pesticides,
not to thiabendazole. In incident I015152‐001, a formulator accidentally added the active
ingredient tebuconazole to a lot of the fungicide product Rival. This lot was applied to soybean,
resulting in an unregistered application of tebuconazole that was believed to have been the
cause of observed plant damage to the soybean crop. The other three incidents involving
exposure to thiabendazole were bee kills in which the bees were exposed to multiple pesticides
(I023967‐001, I029385‐001, and I0296819‐001). In each of these cases, there was exposure to
one or more insecticides that are highly toxic to honeybees. Since one or more of these highly
toxic pesticides likely caused the kill, the certainty level for thiabendazole in each of these was
unlikely. In conclusion, the individually‐reported incidents in IDS that are linked to
thiabendazole do not provide any definitive evidence that use of thiabendazole has caused
mortality to nontarget animals or damage to plants. It is noted, however, that incident reports
generally are not useful for monitoring sublethal effects in animals. There are no individually‐
reported ecological incidents in IDS for thiabendazole hypophosphite.

The search for aggregated ecological incidents in IDS identified no aggregated reports that
included plant, wildlife, or other nontarget organism incidents associated with exposure to any
product containing thiabendazole or thiabendazole hypophosphite.

7 Analysis Plan

7.1 Overall Process

This assessment uses a weight of evidence approach that relies heavily, but not exclusively, on a
risk quotient (RQ) method. RQs are calculated by dividing an estimate environmental
concentration (EEC) by a toxicity endpoint (i.e., EEC/toxicity endpoint). This is a way to
determine if an estimated concentration is expected to be above or below the concentration
associated with the effects endpoint. The RQs are compared to regulatory levels of concern
25
(LOCs). The LOCs for non‐listed species are meant to be protective of community‐level effects.
For acute and chronic risks to vertebrates, the LOCs are 0.5 and 1.0, respectively, and for plants,
the LOC is 1.0. The acute and chronic risk LOCs for bees are 0.4 and 1.0, respectively. In addition
to RQs, other available data (e.g., incident data) can be used to help understand the potential
risks associated with the use of the pesticide.

7.2 Modeling

Various models are used to calculate aquatic and terrestrial EECs (see Table 7‐1).

Table 7‐1. List of the Models Used to Assess Risk


Taxa of Exposure
Environment Exposure Pathway1 Model(s) or Pathway
Concern Media
Vertebrates/
Invertebrates
(including
sediment
Aquatic dwelling) PRZM‐VVWM with PWC
Surface water Runoff to water
version 1.522
Aquatic Plants
(vascular and
nonvascular)

Ingestion of residues
Vertebrate Dietary items T‐REX version 1.5.23
in/on treated seeds
Plants Spray drift/runoff Runoff to plants TERRPLANT version 1.2.2
Terrestrial Ingestion of residues
Bees and other
Contact in/on dietary items as a
terrestrial BeeREX version 1.0
Dietary items result of seed
invertebrates
treatment application
1
Exposure pathways are shown for when the model is applied to a seed treatment use.
2
The Pesticide in Water Calculator (PWC) is a Graphic User Interface (GUI) that estimates pesticide concentration
in water using the Pesticide Root Zone Model (PRZM) and the Variable Volume Water Model (VVWM).
PRZM‐VVWM.
3
The Terrestrial Residue Exposure (T‐REX) Model is used to estimate pesticide concentration on avian and
mammalian food items.

26
8 Aquatic Organism Risk Assessment

8.1 Aquatic Exposure Assessment

8.1.1 Modeling

The Pesticide in Water Calculator (PWC version 1.52) model was used to estimate aquatic
exposure for a seed treatment use that results from an application rate of 0.15 lb a.i./A, based
on the technical registrant Syngenta’s proposal to add this maximum annual rate on labels that
do not specify a maximum rate. This 0.15 lb a.i./A rate has not been assessed in previous risk
assessments except for the 2016 risk assessment for legume vegetables (USEPA 2016a,
D428564). PWC scenarios are used to specify soil, climatic, and agronomic inputs, and are
intended to result in high‐end water concentrations associated with a particular crop and
pesticide within a geographic region. Each PWC scenario is specific to a vulnerable area where
the crop is commonly grown. Soil and agronomic data specific to the location are built into the
scenario, and a specific climatic weather station providing 30 years of daily weather values is
associated with the location. Chemical input parameters and application timing and modeling
scenarios are detailed in Appendix B.

Seed treatments were modeled with PWC scenarios representing wheat, legumes,
ornamentals, potato, brassica, bulb vegetables, corn, cucurbits, and spinach at the depth of 1
inch below ground and an application rate of 0.15 lb a.i./A.

The maximum aquatic EECs correspond with corn seed treatment and those results are
summarized in Table 8‐1. Maximum 21‐day EECs for the other registered seed treatment uses
are summarized in Table 8‐2. Refer to Appendix B for additional information pertaining to
aquatic EECs.

Table 8‐1. Maximum Surface Water EECs for Thiabendazole


Modeling Input Modeling Output
Date App. Rate #
Seed App. 1‐in‐10‐year EEC
Run PWC of in lb App.
Treat Efficiency/ Water Column (µg/L)
Name Scenario Initial a.i./A per
ment Spray Drift
App. Year 1‐day 21‐day 60‐day
Δ
Corn4 MScornSTD.scn ‐7 0.15 1 1/0 0.95 0.67 0.63
1 inch
Refer to Appendix B for all modeled EECs
Δ – The symbol in PWC that represents the pesticide distribution linearly increases with depth at the specified
depth

27
8.1.2 Aquatic Monitoring Data

Surface water monitoring databases were assessed for potential detections of thiabendazole
and thiabendazole hypophosphate in the environment. Groundwater is not assessed in the
DRA, though it is noted that there can be interaction between surface water and groundwater
in vulnerable ecosystems. Thiabendazole was detected in four groundwater samples and is
detailed in the 2018 Drinking Water Assessment (USEPA 2018b).

There is limited surface water monitoring data for thiabendazole prior to 2014. Since 2014,
thiabendazole has been included in regular surface water monitoring by the National Water
Information System (NWIS) and stored in the USGS National Water Quality Assessment
(NAWQA) database (USGS 2015). Thiabendazole has been detected 94 times in surface water
(n=86) and effluent samples (n=8) collected from fifteen states between the years of 2014 and
2018 (as assessed October 2018). However, it should be noted that levels of detection and
quantitation were not noted for every sample. It is uncertain whether these detections are
from seeds coated in thiabendazole or non‐agricultural uses such as antimicrobial and
pharmaceutical uses.

Of the 94 samples, one detection exceeds the maximum 1‐in‐10‐year, daily estimated
environmental concentration in the water column from modeling in this assessment. The
highest concentration was detected in surface water in Georgia on April 15, 2014 at 0.115 μg/L.
All other samples were less than or equal to 0.0382 μg/L. Thiabendazole was also included in
California’s Surface Water database (SURF), but these sample detections were also included in
the NAWQA database.

The salt of thiabendazole, which is used as a tree injection fungicide in ornamental trees:
thiabendazole hypophosphite, is not included at all in the monitoring databases.

8.2 Aquatic Organism Risk Characterization

8.2.1 Aquatic Vertebrates

Previous risk assessments for conventional uses have concluded that thiabendazole poses low
acute and chronic risk to aquatic vertebrates. Nothing has changed since those risk assessments
were done that would alter the risk conclusions. To confirm the previous risk conclusions, EFED
compared the acute and chronic toxicity data to the new aquatic EECs that were modeled for
seed treatment uses at the maximum annual rate of 0.15 lb a.i./A. EFED found that all acute
and chronic RQs were <0.01 for all use sites. EFED therefore continues to conclude low risk to
aquatic vertebrates for all conventional uses.

28
8.2.2 Aquatic Invertebrates

Previous risk assessments have concluded that all uses of thiabendazole pose low acute and
chronic risk to aquatic invertebrates. Nothing has changed since those risk assessments were
done that would alter the risk conclusions.

Aquatic Risk from Seed Treatment Uses

To confirm the previous risk conclusions, EFED compared the acute and chronic toxicity data to
the new aquatic EECs that were modeled for seed treatment uses at the maximum annual rate
of 0.15 lb a.i./A. For acute risk, EFED found that all acute RQs were <0.01 for all use sites. RQs
for chronic risk to aquatic invertebrates were slightly higher and are presented in Table 8‐2.
This analysis found that chronic RQs were well below the chronic LOC of 1.0 for both freshwater
and saltwater species. EFED therefore continues to conclude that all seed uses of thiabendazole
poses low risk to aquatic invertebrates.

Table 8‐2. Chronic Aquatic Invertebrate Risk Quotients


Risk Quotients
21‐Day Average Freshwater Saltwater
Use Sites PWC Scenario
EEC1 (µg/L) NOAEC = NOAEC =
42 µg a.i./L 46 µg a.i./L
Alfalfa TXalfalfaOP.scn 0.44 0.01 0.01
Corn MScornSTD.scn 0.67 0.02 0.01
Grains (barley, oats, rye,
NDwheatSTD_+0 0.47 0.01 0.01
triticale, and wheat)
Brassica Vegetables FLcabbageSTD.scn 0.40 0.01 0.01
Potato MEpotatoSTD.scn 0.38 0.01 0.01
Root Vegetables
GAOnion_WirrigSTD.scn 0.28 0.01 0.01
(other than potato)
Cucurbit Vegetables FLcucumberSTD.scn 0.56 0.01 0.01
Legume vegetables (peas
ILbeansNMC.scn 0.57 0.01 0.01
and beans)
Spinach CAlettuceSTD.scn 0.47 0.01 0.01
Ornamental plants (root or
FLnurserySTD_V2.scn 0.25 0.01 0.01
bulb)
1
The EECs used to calculate this RQ are based on the 1‐in‐10‐year 21‐day average value from Table 8‐1.

Risk to sediment‐dwelling invertebrates were not assessed; however, EFED believes that the
risk of thiabendazole from seed treatment uses is low. As is evident by the low aquatic EECs,

29
little thiabendazole is expected to reach the aquatic environment. Factors that limit the
transport of residues to aquatic habitats include:
 Low application rates for seed treatment uses
 No movement via spray drift
 Extraction from seed coats will be limited by the compound's high sorption, and any
extracted compound will likely bind strongly to soil
 Limited transport in runoff because of the low mobility in soil
 Limited transport in because treated seeds are generally buried

Considering the low expected exposure to benthic habitats, and the low acute and chronic risk
conclusions for free‐swimming aquatic invertebrates, EFED predicts low risk to sediment‐
dwelling invertebrates.

Aquatic Risk from Mushroom Use

Although application of thiabendazole in mushroom culture takes place indoors, after the
mushrooms are harvested, the spent mushroom compost (SMC) on which thiabendazole was
sprayed may be utilized as a soil amendment outdoors. This outdoor application of spent
mushroom compost could result in release of thiabendazole into the environment. The amount
of exposure would depend on several factors, including:

 The number and timing of applications made during mushroom culture


 The amount of degradation and dissipation of residues that occurs during the
composting, sterilization, storage (“weathering”), and distribution of the SMC, prior to
being applied to soil
 The quantity, depth, and acreage at which the SMC is applied to soil
 The spatial scope of the use of SMC relative to the area of the watershed
 The degree that the residues would be sequestered through strong binding to the
organic matter in the compost and soil

EFED does not have enough information on these factors to make realistic modeling predictions
to assess possible risk to aquatic organisms. Grogan and Jukes (2003) provide some information
on the persistence of thiabendazole in mushroom casing soil during mushroom culture. They
found that residues of thiabendazole in casing soil remained high for the first 31 days after the
first application, while the mushroom were being harvested, but decreased rapidly by day 31,
when the mushroom harvest was completed and the casing soil was beginning to dry out. At
Day 35, recovered residues were only 10‐15% of the amount applied. However, as was
discussed in the response to comments on the problem formulation (DP 421319), the rapid
decrease in recovered residues between day 31 and day 35 could reflect limitation in the
30
methanol extraction after the soil had dried and residues had become tightly bound. In any
case, this information only covers the time between application and the end of the mushroom
harvest. Further degradation and dissipation may occur during the composting process, and
weathering and storage of the compost. The SMC may sometimes be “weathered” for several
months before being applied to reduce the salt content (Oregon State University Extension
Service, 2003). Finally, SMC is often sterilized with steam before being sold, and the high
temperatures of this process may accelerate degradation, or it may retard degradation by
destroying microbials that could metabolize the compound.

Another factor that is expected to limit aquatic exposure is binding of thiabendazole to organic
matter in the SMC. Grogan and Jukes (2003) states that mushroom casing soil typically contains
80% peat, which typically contains over 90% organic matter on a dry weight basis.
Thiabendazole binds tightly to soil as indicated by the high soil/water partitioning coefficients
(Koc > 1,000 mL/goc). Therefore, most of the residues in SMC are expected to remain tightly
bound and would not be mobile in surface runoff.

The spatial scope of the use of SMC is expected to be very limited. Pennsylvania is the largest
producer of fresh mushrooms in the United States, accounting for 63 percent of total white
mushroom production in the country (MFPA, 2017). California is the second highest producer of
white button mushroom, though there are many mushroom growing facilities across the
country. According to the Mushroom Farmers of Pennsylvania (MFPA), spent mushroom
substrate supports more than 230,000 acres of Pennsylvania farmland for crops such as corn,
pumpkin, tomato, and potato, and a literature review also indicates that spent mushroom
compost/substrate is used on vineyards and extensively on turf (Webster & Buckerfield, 2003;
Pennsylvania State University Extension). Mushroom farmers may also sell spent mushroom
substrate directly to municipalities, home gardeners, garden centers, landscaping companies,
and corporate clients in close proximity to mushroom growing facilities. SMC may also be a
component of potting soil mixes, casing material in the cultivation of subsequent mushroom
crops, in vermiculture as a growing medium, wetlands for remediation of contaminated soils,
bedding material for animals, animal feed, as well as mining reclamation (Rinker, 2002;
Stehouwer et al., 2012). Though there several potential off‐site many uses exist, this exposure
is expected to be mostly localized to area near mushroom growing facilities.

Though some literature suggests that some reductions in thiabendazole residues may occur
prior to application of SMC to outdoor soil, and that residues that do remain in SMC may
remain tightly bound to the organic matter based on the Koc, the extent of this is unknown
especially since thiabendazole has been detected in surface water. It is assumed that the
majority of SMC use is localized near mushroom growing facilities in Pennsylvania and
California, but the quantity and depth of SMC that would be applied is unknown. As such, EFED
does not have enough information to make realistic modeling predictions to assess possible risk
to aquatic organisms.
31
Aquatic Risk from Post‐Harvest Uses

Post‐harvest uses of thiabendazole include applications to non‐stored and stored commodities,


including citrus, pome fruit (apple, pear), root and corm vegetables (potato including sweet,
carrot), tropical fruits including banana, plantain, mango, and papaya, and sugar beet.
Application methods include a dip/wash (wax or oil), thermal fogger, and drench. Target
concentrations are variable depending on the crop (up to 5,000 ppm solution).

There is a potential for thiabendazole residues to be discharged into receiving waterbodies


from post‐harvest commodity applications. Generally, any wastewater from post‐harvest
applications are expected to move into drainage systems that are received by publicly‐owned
treatment works (POTWs), rather than surface water drains that would move directly into
receiving waterbodies. EFED notes that some product labels with post‐harvest uses include
language that prohibits discharging effluent into waterbodies or sewer systems unless prior
notification and approval in accordance with the requirements of a NPDES permit is obtained
prior to release of contaminated effluent. Consideration should be given to making this
consistent across all product labels with post‐harvest uses, as appropriate.

8.2.3 Aquatic Plants

Risk quotients were calculated for risk to aquatic plants for various seed treatment uses of
thiabendazole (Table 8‐3). For all uses, the one‐day average modeled surface water EEC was far
below the IC50 toxicity endpoint for vascular and nonvascular aquatic plants, resulting in RQs
that were less than 0.01 for all uses. Therefore, EFED concludes that all seed treatment uses of
thiabendazole pose low risk to aquatic plants.

Table 8‐3. Aquatic Plant Risk Quotients for Non‐Listed Species


Risk Quotients
1‐in‐10 Year Daily Vascular Non‐vascular
Use Sites PWC Scenario
Average EEC µg/L IC50 = 2.32 mg IC50 = 1.42 mg
a.i./L a.i./L
Alfalfa TXalfalfaOP.scn 0.63 <0.01 <0.01
Corn MScornSTD.scn 0.95 <0.01 <0.01
Grains (barley, oats, rye,
NDwheatSTD_+0 0.37 <0.01 <0.01
triticale, and wheat)
Brassica Vegetables FLcabbageSTD.scn 0.54 <0.01 <0.01
Potato MEpotatoSTD.scn 0.42 <0.01 <0.01
Root Vegetables 0.40
GAOnion_WirrigSTD.scn <0.01 <0.01
(other than potato)
Cucurbit Vegetables FLcucumberSTD.scn 0.76 <0.01 <0.01

32
Legume vegetables (peas 0.67
ILbeansNMC.scn <0.01 <0.01
and beans)
Spinach CAlettuceSTD.scn 0.65 <0.01 <0.01
Ornamental plants (root or 0.37
FLnurserySTD_V2.scn <0.01 <0.01
bulb)
The LOC for non‐listed plants is 1. The endpoints listed in the table are the endpoint used to calculate the RQ

8.3 Thiabendazole Hypophosphite (Tree Injection Use)

Thiabendazole hypophosphite, a salt of thiabendazole, is used as a tree injection fungicide for


control of certain fungal diseases in elms, London plane, oak, and sycamore trees. It is expected
to be used only sporadically for highly‐prized ornamental and shade trees, and therefore only a
small number of trees are expected to be treated within any watershed. Any potential aquatic
exposure would be primarily from residues being transported into leaves and other plant parts
that are shed and fall into a water body. Small amounts may also leach from leaves that fall
onto soil and are transported to water in runoff, but because of the low mobility of
thiabendazole, this route is expected to be very limited. EFED expects that the contamination of
a pond or other water body by these routes would be much less than those resulting from
agricultural seed treatment uses of thiabendazole. Because the agricultural seed treatment
uses do not result in expected environmental concentrations that would be toxic to aquatic
plants or animals, the smaller exposure from the tree injection use is also not expected to pose
risk to aquatic animals and plants.

9 Terrestrial Vertebrates Risk Assessment

9.1 Terrestrial Vertebrate Risk Characterization

9.1.1 Acute Risk

Because of low acute toxicity and relatively low application rates, previous risk assessments
have concluded that all uses of thiabendazole pose low acute risk to terrestrial vertebrates. The
only new data on acute vertebrate toxicity that has been submitted is a sub‐acute dietary study
with a passerine bird, the canary (MRID 50103004). As with acute and subacute tests with the
bobwhite and mallard, this study found no mortality or adverse effects when tested at the limit
dose or concentration, which in this case was 5,298 mg a.i./kg. These data show that the
previous conclusion of low acute risk also applies to passerine birds.

General upper‐bound acute risk screen for seed treatment uses of thiabendazole can be done
by comparing exposure at the maximum allowable annual rate for most uses of 0.15 lb a.i./A to
the acute oral toxicity findings. Using this maximum rate and assuming that the seeds are
33
broadcasted on the surface (a conservative assumption), the T‐REX model calculates that 1.56
mg of thiabendazole (on treated seeds) would be available on the soil surface. This is a small
fraction of the oral dose that has been shown to be nontoxic to birds and mammals in the acute
oral tests (2250 mg a.i./kg and 4734 mg a.i./kg for mammals). Because the exposure in one
square foot of surface area is much less than 0.5 times the acute oral LD50 value, the LD50‐
square‐foot risk assessment method indicates low acute risk to birds and mammals.

No incidents have been reported that indicate adverse effects to terrestrial vertebrates
attributed to exposure to thiabendazole. Since incident reports generally reflect only mortality
caused by acute toxicosis, this finding is consistent with the conclusion of low acute risk but
does not provide evidence on risk of sublethal effects from chronic exposure.

9.1.2 Chronic Risk

Chronic toxicity testing has found that the threshold for sublethal effects to the rat (i.e., the
chronic LOAEL) is 30 mg a.i./kg per day. This chronic toxicity threshold is over 150 times lower
than the acute LD50 (> 4734 mg a.i./kg‐bw). The chronic risk threshold for birds is unknown
since the avian reproductive tests with the bobwhite and mallard failed to determine the
LOAEC. These studies found no observable adverse effects at the dietary concentration of 400
mg a.i./kg‐diet, and therefore the threshold must be above that level. In the chronic rat
reproduction study, significant decreases in the body weight gain of both the parents and
offspring were observed in both the F0 and F1 generations at 30 mg a.i./kg‐bw. This dose is
approximately equivalent to the dietary dose of 600 mg a.i./kg‐diet. It is possible that similar
growth effects may occur in birds at these higher levels, but this is speculative since effects may
differ in birds.

Because the primary route of exposure for terrestrial vertebrates is expected to be from
consumption of treated seeds, previous risk assessments have focused on chronic risk to
granivores from treated seed consumption. No information on chronic toxicity or exposure
have become available since previous risk assessments were completed; therefore, the
previously‐calculated chronic RQs for thiabendazole seed treatment uses are still valid. The
chronic RQs for birds and mammals are reproduced in
Table 9‐1. For mammals, the RQs are presented for small animals because they are the most
sensitive, and because small seed‐eating rodents (mice) play an important role in many
terrestrial ecosystems.

34
Table 9‐1. Chronic RQ Values for Granivorous Birds and Mammals Eating Seeds Treated with
Thiabendazole (T‐REX v. 1.5.2)
Chronic RQ
Mammals
Use Site Birds NOAEL = 10 mg a.i./kg‐bw
NOAEC ≥400 mg a.i./kg‐diet
Small Medium
2014 Risk Assessment (DP 410836, USEPA 2014d)
Alfalfa 5.00 19.3 16.5
Barley 2.31 8.9 7.6
Oats 3.00 11.6 9.9
Rye 2.98 11.5 9.8
Triticale 3.75 14.5 12.4
Wheat 2.98 11.5 9.8
Broccoli 1.65 6.4 5.4
Cabbage 1.82 7.0 6.0
Onion 1.43 5.5 4.7
Cucumber 10.0 38.6 32.9
Muskmelon 11.5 44.2 37.8
Pumpkin 3.53 13.6 11.6
Squash, summer 3.53 13.6 11.6
Squash, winter 3.53 13.6 11.6
Watermelon 5.29 20.4 17.4
Spinach 1.50 5.8 4.9
Carrot 4.41 17.0 14.5
Radish 0.55 2.1 1.8
Parsley 3.27 12.6 10.8
Turnip 1.84 7.1 6.1
Soybean 0.60 2.3 2.0
2016 Risk Assessment (DP 428564, USEPA 2016a)
Crop Groups 6 and 7
1.38 5.31 4.54
(Beans and Peas)
Bolded values exceed the LOC for chronic risk.

For birds, the chronic RQs range from 0.55 to 11.5. The RQs indicate possible chronic risk to
seed‐eating birds for all seed treatment uses except radish and soybean. For mammals, chronic
RQs range from 1.8 to 44.2. All of the mammalian RQs exceeded the LOC of 1.0, and therefore
chronic risk to seed‐eating small mammals is indicated for all seed treatment uses.
The avian chronic RQs are uncertain because they are based on NOAEC values that were
derived from avian reproductive studies in which no adverse effects were observed at any of
35
the test concentrations. Since the studies did not identify the threshold of sublethal effects to
birds, it is uncertain if the predicted exposure to seed‐eating birds would be great enough to
cause sublethal effects to growth or reproduction. RQs above 1 therefore do not necessarily
mean that chronic risk is high. In contrast, the chronic mammalian study defined the threshold
of sublethal effects with both a NOAEL and LOAEL level, and therefore EFED has greater
confidence in the chronic risk conclusions for mammals.

Based on these previous RQ analyses, it is uncertain if sublethal effects to birds would occur
when the seed treatment rate is greater than 400 mg a.i./kg seed. For mammals, sublethal
effects are predicted when the seed treatment rate is greater than 100 mg a.i./kg seed.

Risk Characterization for Seed‐Eating Mammals and Birds

Guidance was finalized in 2016 that provides updated risk assessment methodology for better
characterizing risk to birds and mammals that may feed on treated seeds (USEPA 2016b). This
guidance provides two methods that characterizes exposure, taking into account the beneficial
effect of reduced exposure from burial or incorporation of seeds during planting. For better
characterization of chronic risk, the methodology provides equations for calculating two
theoretical parameters: 1) the foraged area of concern and 2) the foraged time of concern. The
foraged area of concern is defined as the amount of area the target species would have to
cover while foraging to consume enough pesticides from treated seeds to exceed the LOC. This
parameter is applicable to characterizing risk to birds and mammals. The foraged time of
concern is defined as the length of time that an individual animal would need to forage (at an
assumed maximum foraging rate) to consume enough pesticide from treated seeds to exceed
the LOC. Because of the lack of information on the foraging rate of granivorous mammals,
foraging time of concern method is currently applicable only for birds.

The results of these analysis are presented here. A complete presentation of these analyses is
provided in Appendix G.

Chronic Area of Concern Analysis for Mammals

The Chronic Area of Concern (CAC) is defined area that a mammal would need to forage to
consume enough seeds to reach the chronic NOAEL, assuming it ate all the exposed seeds in
that area. The results show that the seed treatment rate, seed planting rate, and planting
method have large influence on the CAC for mammals. The CAC varied greatly from 5 square
feet for small mammals feeding on rye seeds to a maximum of 134,000 square feet for medium
mammals feeding on watermelon seeds. Crops for which the CAC is small, comprising less than
10% of the mammal’s home range, are the following:

36
 Alfalfa
 Wheat, oats, and other small grains
 Onion
 Carrot

When alfalfa, wheat, oats, and other small grains are drill‐seeded, which is typical, the CAC
would be larger because fewer seeds would remain on the surface; however, the areas would
still be no greater than 2% of the home range. Since the CAC for these crops represent only a
small portion of the home range, the potential for a mammal to consume a toxic amount of
seeds is high. These results therefore support the conclusion of potential sublethal effects to
small mammals consuming treated seeds. When onions and carrots are started in greenhouses
and then transplanted to the field, however, chronic risk would be low.

The CACs are somewhat larger, but still well below the home range size (no more than 23%), for
the following crops and crop groups:

 Beans and peas (crop group 6 and 7)


 Some root crops (e.g., turnip and parsley)
 Spinach

The CACs are largest for watermelon and pumpkin. The conclusions of potential sublethal
effects to small mammals is least certain for these crops because the CACs are relatively high
and, at the high end of the range, exceeds the predicted size of the home range. Risk of
sublethal effects appears to be low for watermelon for which the CAC represents between 46%
and 329% of the home range.

Results are uncertain for all other crops included in this analysis. For some they are uncertain
because the CAC and percentage of the home range fall in a moderate range, while for others it
is because the percentages range from very low to very high values, due to extreme variation in
seed planting rates.

Chronic Area of Concern Analysis for Birds

For all crops, the CAC is no more than 45% of the bird’s home range, with several estimates
showing well less than 10% of the CAC. Therefore, the foraging area of concern analysis does
not dispute the potential for sublethal effects to seed‐eating birds for any use site. However,
the low CAC values do not necessarily confirm risk because available avian reproduction tests
did not test high enough to determine a definitive LOAEC. Testing at higher levels could find
that the NOAEC is considerably greater than 400 mg a.i./kg diet, which would mean these
calculations overestimate risk.

37
The analysis does indicate that chronic avian risk is greater for some use sites than for others.
Cucurbit vegetable crops, especially pumpkin and watermelon, have the largest CAC values,
indicating the lowest risk among the use sites. This is mainly because the seeds are planted
widely apart. At the upper range, the CAC for pumpkin and watermelon comprises 24% to 45%
of the bird’s home range. The brassica vegetable crops, broccoli and cabbage, had CAC values in
the middle of the range (up to 9‐13% of the home range), indicating moderate risk compared to
the other use sites. Small grains, legumes, root crops, alfalfa, and spinach had the lowest CAC
values (<4% of the home range), indicating greatest potential for sublethal effects.

Chronic Time of Concern Analysis for Birds

The 2016 guidance memorandum (USEPA, 2016) provides a second method for characterizing
the risk to birds that involves calculation of a second value called the chronic time of concern
(CTC). This is the estimated minimum amount of time that a bird would require to consume
enough treated seeds to reach the NOAEL. This time is then compared to the total time that a
bird would have to forage for seeds in a day, which is estimated at 8 hours.

This analysis indicates that the CTC generally is no more than 200 minutes (3 1/3 hours). The
lower range of the CTC is often less than 30 minutes. Considering that a bird can forage for up
to 8 hours a day, the CTC represents only a small fraction of the available foraging time.
Therefore, these results do not dispute the potential for sublethal effects after consuming
treated seed, for any use site. However, as with the CAC analysis, the results do not necessarily
indicate risk because the 400 mg a.i./kg diet estimate may underestimate the true NOAEC.
Furthermore, this analysis is conservative because it only accounts for the time it takes to
handle seeds while eating them but does not account for the time it can take for the bird to find
each seed.

When comparing use sites, brassica vegetables (represented by broccoli and cabbage), root
vegetables, and legumes have larger CTC values, indicating lower risk. Spinach, cucumber,
squash, melons, and small grains such as wheat and oat have smaller CTC values, indicating
greater potential for birds to reach a toxic dose by eating seeds.

Comparison of seed size to the maximum size that can be eaten by a bird shows that pumpkin,
squash, and peas are too large for small birds to eat. Beans are also too large for small and
medium size birds. These use sites therefore would have low chronic risk to these types of
birds.

Influence of Planting Method

Risk to birds and mammals will be influenced by the percentage of planted seeds that remain
on the surface of the soil and thus readily available for foraging animals. Fewer seeds remaining
38
on the surface will reduce the probability of an animal ingesting a toxic number of treated
seeds. Planting of seeds with a drill seeder will generally result in a smaller percentage of seeds
on the surface than broadcast seeding or planting methods involving mixing seeds in the top
layer of soil. Even with drill seeding, however, significant numbers of seeds may be spilled on
the surface at the end of rows where the equipment is raised out of the ground. EFED assumes
1% of seeds remain on the surface with all types of drill seeders. Snoo and Luttik (2004) showed
that use of a precision drill seeder results in far fewer seeds exposed on the surface than does
use of a standard drill seeder. The percentage of wheat seeds exposed in the center of the field
was 0.14% for precision‐drilled seed, compared to 0.61% for standard‐drilled seed. At the row
ends, the percentage of seeds exposed was 0.5% for precision‐drilled seed, compared to 3.3‐
9.2% for standard‐drilled seed.

Seeds of some crops may be sown by broadcasting on the surface followed by use of soil
incorporation equipment to mix the seeds into the upper layer of soil. EFED assumes that this
type of planting results in 15% the seeds remaining exposed on the surface. In this assessment,
this planting method was assumed as a maximum exposure scenario for all crops that have a
recommended planting depth of ½ inch or less, based on planting recommendations given by
the Penn State Extension (Sanchez, 2011). These crops also may be drill seeded, which would
reduce the number of exposed seeds, and thus would reduce risk to seed‐eating animals.

Some vegetable crops are sometimes started in greenhouse and later transplanted to the field
as seedling. When this is done, negligible exposure to terrestrial wildlife is expected because
animals would not have access to the seeds. According to information provided by BEAD
(USEPA 2011b), crops that are sometimes planted as transplants include many of the brassica
vegetables (broccoli, Brussels sprouts, cabbage, and cauliflower), muskmelon, onion, parsley,
squash, sweet potato, and watermelon.

Terrestrial Risk for Potato, Sweet Potato, and Ornamental Bulbs

Besides seed treatment uses, thiabendazole is used to protect potatoes, sweet potatoes, and
ornamental bulbs and corms. For potatoes, thiabendazole typically is applied to the harvested
potato tubers to prevent damage from fungal diseases. This includes tubers that are later cut
into seed pieces and planted. The tubers are treated prior to storage over winter, which
typically will last three months or more. Similarly, thiabendazole is used to protect bulbs and
corms of ornamental plants prior to storage over winter. The levels of residues that would
remain on the tubers, bulbs, and corms when they are planted in the spring is uncertain, but
considering the high persistence of thiabendazole, degradation over this period in these
conditions may be minimal. Generally, EFED does not expect the planted tubers, bulbs, and
corms to be eaten by as many species of wildlife as would eat seeds that remain on the surface.
Squirrels and fossorial (burrowing) mammals such as gophers would be the most likely to eat
them.
39
For sweet potatoes, thiabendazole is applied to cuttings of roots or vines, called slips, that are
used to start new plants. According to current product labels, thiabendazole is applied to the
slips just prior to planting. The slips are then grown into small plants, which are later
transplanted into agricultural fields. Sweet potato slips may be started indoors in a greenhouse,
or in an outdoor plot. Those that are planted outdoors may result in some exposure to animals
that may pull up and eat the slips, such as deer, raccoon, and some small mammals, but is
expected to be negligible exposure.

Terrestrial Risk for Mushroom Use

Thiabendazole may be applied to mushrooms during cultivation at any time from spawning up
to 12 hours prior to harvest. Because mushrooms are grown indoors, applications made during
cultivation are not expected to expose wild animals. Once the mushrooms have been
harvested, the substrate on which the mushrooms were grown are typically composted and
sold as spent mushroom compost (SMC). The SMC can be applied outdoors to cropland,
gardens, and lawns, which raises the potential for some dermal, inhalation, and dietary
exposure to terrestrial animals that feed in these areas. There is also potential for some runoff
from these areas, which could expose aquatic organisms. However, these exposure routes are
expected to be minimal because of the very limited spatial extent of this use; this route is
expected to contribute little to the overall environmental exposure to thiabendazole.

9.2 Thiabendazole Hypophosphite (Tree Injection Use)

Thiabendazole hypophosphite, a salt of thiabendazole, is used as a tree injection fungicide for


control of certain fungal diseases in elms, London plane, oak, and sycamore trees. It is expected
to be used only sporadically for highly prized ornamental and shade trees. Some exposure is
possible to terrestrial wildlife that feed on fruit, nuts, or foliage from treated trees, although it
is uncertain if this exposure would reach toxic levels. Considering the very limited scale of this
use, EFED does not expect this it to result in any more than very localized exposure to
nontarget organisms.

10 Terrestrial Invertebrate Risk Assessment

10.1 Terrestrial Invertebrate Pollinators, Tier I Exposure Estimates

Use of thiabendazole will result in limited exposure to terrestrial invertebrates because the only
outdoor uses are seed treatments and treatment of bulbs or tubers. These uses generally are
not associated with contact exposure to bees or other insect pollinators, except possibly limited

40
exposure to airborne dust that may abraded off the seed coating during planting. Considering
the low acute contact toxicity of thiabendazole to the honeybee, contact exposure to dust
during planting is expected to pose negligible risk. The primary exposure routes to insect
pollinators is dietary exposure resulting from translocation to parts of the emerging plant that
are used as food or water, including pollen, nectar, guttation fluid, and honeydew (USEPA
2014). The Bee‐REX model (Version 1.0) was used to calculate upper‐bound dietary EECs for
seed treatment applications of thiabendazole.

On‐Field Risk

A single risk assessment was conducted for all seed treatment uses based on the maximum
annual limit of 0.15 lb a.i./A that is present for on most labels of seed treatment products.
Because all outdoor uses are seed treatments, risk is only assessed for oral exposure. The Tier 1
assessment considers just the caste of bees with the greatest oral exposure (foraging adults and
larval workers).

Because of solubility limits and low toxicity of thiabendazole, the acute and chronic honeybee
toxicity tests could not be conducted to high enough dietary concentrations to yield definitive
LD50 and NOAEL values. Table 10‐1 shows the nondefinitive endpoints, expressed as “greater
than” values, along with maximum oral doses predicted by the BeeREX Model (version 1.0). The
acute LD50 is more than 2.5 times greater than the maximum EEC; therefore, acute oral
exposure route is expected to be of low risk for adult and larval bees. Likewise, because the
chronic tests determined that the chronic NOAEL is more than the maximum EEC, sublethal
effects are not expected at EECs for adult and larval bees. Therefore, EFED concludes that all
uses of thiabendazole pose low acute and chronic on‐field risk to terrestrial insect pollinators.
Additionally, relative to the currently registered uses, EFED believes that the submission of
higher tier bee data (e.g., Tier 2 and tier 3 testing) would be of low value for this assessment.

Table 10‐1. Tier 1 (Default) Oral Risk Estimation for Adult Nectar Forager and Larval Worker
Honey Bees
Max. RQ
Chronic
Use Single Bee Oral Dose1 Acute LD50
NOAEL
Pattern Appl. Caste/Task (μg a.i./bee) (μg a.i./bee)
(μg a.i./bee) Acute Chronic
Rate
Adult nectar
0.29 >4 >2.57 <LOC <LOC2
0.15 lb forager
All crops
a.i./A Larval
0.13 >7.26 >0.98 <LOC <0.13
worker
1
Maximum total dose among all modeled adult and larval bee caste predicted by the BeeREX model.
2
RQ is not presented because the chronic adult bee NOAEL should not be used for quantitative analysis.

41
Off‐Field Risk

Because on‐site risk is below the level of concern, off site risk also is below the level of concern,
and no further assessment was necessary.

10.2 Terrestrial Invertebrates, Non‐Pollinators

Little information is available on the risk of thiabendazole to terrestrial invertebrates other than
pollinator insects. However, EFED notes that the use of thiabendazole as a seed treatment,
along with its known persistence in terrestrial environments, makes prolonged exposure to soil‐
dwelling invertebrates in the vicinity of treated fields possible. There is also evidence that
thiabendazole might be hazardous to nontarget invertebrates. Thiabendazole is used as an
anthelmintic drug to treat nematodes in humans and as a veterinary anthelmintic drug for
animals (Budavari et al., 1989). It is possible that the mode of action that makes it toxic to
parasitic worms could also pose a risk to soil invertebrates, especially annelids. The 14‐day LC50
for earthworms is 437 mg a.i./kg, indicating moderate toxicity (University of Hertfordshire,
2019)

10.3 Thiabendazole Hypophosphite (Tree Injection Use)

Thiabendazole hypophosphite, a salt of thiabendazole, is used as a tree injection fungicide for


control of certain fungal diseases in elms, London plane, oak, and sycamore trees. If trees are
treated in the spring at or just prior to blooming, some residues of thiabendazole are expected
to be transported into the flowers. This could result in some exposure to bees and other insect
pollinators. However, these trees are wind pollinated and are not very attractive to bees.
Considering the relatively low acute and chronic toxicity of thiabendazole, along with the low
attractiveness, this exposure is not expected to pose significant risk to bees or other insect
pollinators.

11 Terrestrial Plant Risk Assessment

EECs for terrestrial plants were calculated using TERRPLANT v.1.2.2. Exposure was estimated for
a single application at 0.15 lb a.i./A, the maximum annual application limit stated on most
labels. Since the only outdoor uses are treatments of seeds, seed pieces, tubers, and bulbs, the
model assumes exposure only from runoff. Based the measured aqueous solubility of 28 mg/L
(MRID 40947301), the model assumed a moderate runoff fraction of 0.02. For a dry area
adjacent to the treatment area, runoff exposure is estimated as sheet runoff. Sheet runoff is
the amount of pesticide in water that runs off of the soil surface of a target area of land that is
equal in size to the non‐target area (1:1 ratio of areas). For wetlands, runoff exposure is

42
estimated as channel runoff. Channel runoff is the amount of pesticide that runs off of a target
area 10 times the size of the non‐target area (10:1 ratio of areas). Exposure from runoff was
then compared to measures of survival and growth (e.g., effects to seedling emergence and
vegetative vigor).

Normally, the seedling emergence and vegetative vigor IC25 values are entered in the
TERRPLANT model to generate terrestrial plant RQs. However, the tier‐1 studies of seedling
emergence (MRID 48996306) and vegetative vigor (MRID 48996307), the IC25 was not
determined because less than 25% inhibition was observed in all test species at the single test
rate of 0.23 a.i./A. This rate was therefore entered into the model in place of the IC25. Since this
rate is less than the actual (unknown) IC25 values, the model returns ratios that are less than the
actual RQ. The ratio returned was <0.1 for plants in dry areas and 0.13 for plants in wetland.
Therefore, the results show that the RQs are less than the LOC for terrestrial plants (1.0),
indicating low risk to terrestrial plants for all uses of thiabendazole.

12 Conclusions

Given the low application rates and lack of spray drift exposure associated with seed
treatments and tuber/bulb treatments, together with the low acute toxicity levels and
moderate mobility, ecological risks of agricultural uses of thiabendazole are generally low.
Consistent with previous risk assessments, all conventional uses of thiabendazole are predicted
to pose low acute and chronic risk to fish, aquatic invertebrates, aquatic stages of amphibians,
aquatic plants, terrestrial invertebrates, and terrestrial plants.

Risks to terrestrial vertebrates (birds, mammals, reptiles, and terrestrial phases of amphibians)
are also expected to be low except for those animals that feed primarily on treated seeds.
There is a potential for sublethal effects (impaired growth and/or reproduction) to birds and
mammals that feed extensively on thiabendazole‐treated seeds in field. (Reptiles and
amphibians are not expected to be at risk because they generally do not feed extensively on
seeds). Because the two available avian reproductive studies failed to test high enough to
determine a definitive LOAEC, the potential for sublethal effects on seed‐eating birds is
uncertain and cannot be ruled out except for use on radish and soybean seeds. Chronic LOCs
for seed‐eating mammals were exceeded for all treated seed crops. RQs indicate chronic risk
for all seed treatment uses (RQs 2.3 to 44.2).

Additional risk characterization analysis done in this assessment did not confirm or refute the
potential for sublethal effects to birds and mammals, but it did help to differentiate relative risk
among different uses. The Area of Concern analysis indicates that the area animals would need
to forage for seeds to reach a potentially toxic dose of thiabendazole, assuming they consume
exclusively treated seeds, is generally not beyond what is plausible. The analysis suggests that a
43
relatively small foraging area would be needed to pose potential effects on mammals if they fed
on treated seed of alfalfa, onion, carrot, and small grains such as wheat and oat, indicating the
greatest potential for effects with these seed treatment uses. Likewise, the Time of Concern
analysis found that the time required for an animal to reach a toxic dose is not beyond what is
plausible. The analysis found a relatively short period of foraging time would be needed to
potentially elicit sublethal effects in mammals if feeding on treated seeds of spinach, cucumber,
squash, melons, and small grains such as wheat and oat, indicating a greater potential for
effects with these seed treatment uses. These analyses assume that the seeds are directly
planted in the field. The risk would be low for vegetable crops when the seeds are started
indoors and then transplanted into the field as seedlings.

A quantitative risk assessment for the tree injection and mushroom use patterns was not
warranted due to a high degree of uncertainty in exposure and relatively small spatial scale of
these use patterns. However, a qualitative assessment of these uses concludes that they likely
pose minimal risk to terrestrial animals.

Screening level down‐the‐drain exposures from the industrial release of thiabendazole from
pulp and paper mills indicated that freshwater fish and invertebrate acute concentrations of
concern (COCs) are exceeded 38‐291 days per year at the maximum labeled concentration of
1250 ppm a.i. and 0‐10 days per year for the lower concentration of 50 ppm a.i. Similarly,
chronic COCs are exceeded 73‐353 days per year with the maximum application rate but are
reduced to 2‐74 days per year with the low rate. COCs for aquatic plants are exceeded 3‐51
days at the maximum labeled application rate, but not exceeded at the low application rate.
Potential risks to the receptor groups cannot be ruled out for any day in which COCs are
exceeded. More information regarding antimicrobial uses may be found in Appendix H.

13 Literature Cited

Armitage, J. M., & Gobas, F. A. P. C. 2007. A terrestrial food‐chain bioaccumulation model for
POPs. Environmental Science and Technology, 41: 4019‐4025.
Budavari, S., M.J. O’Neil, A. Smith, and P. E. Heckelman (Eds.). 1989. The Merk Index. Eleventh
Edition. Merk & Co. Inc. Rahway, NJ. Pp. 1462‐1463.
FAO. 2000. Appendix 2. Parameters of pesticides that influence processes in the soil. In FAO
Information Division Editorial Group (Ed.), Pesticide Disposal Series 8. Assessing Soil
Contamination. A Reference Manual. Rome: Food & Agriculture Organization of the
United Nations (FAO). Available at
http://www.fao.org/DOCREP/003/X2570E/X2570E06.htm (Accessed April 7, 2017).

44
Goring et al., 1975. Goring C.A.I., Laskowski D.A., Hamaker J.W., Meikle R.W. (1975) Principles
of Pesticide Degradation in Soil. In: Haque R., Freed V.H. (eds) Environmental Dynamics
of Pesticides. Environmental Science Research, vol 6. Springer, Boston, MA
Grogan, H. M. and A. A. Jukes. 2003. Persistence of the fungicides thiabendazole, carbendazim
and prochloraz‐Mn in mushroom casing soil. Pest Manage. Sci. 59:1225‐1231.
MFPA, 2017. Mushroom Farmers of Pennsylvania. As assessed on 7/10/2018
< http://www.pamushrooms.com/>
NAFTA. 2012 Guidance for Evaluating and Calculating Degradation Kinetics in Environmental
Media. December 2012. NAFTA Technical Working Group on Pesticides. Available at
http://www.epa.gov/oppfead1/international/naftatwg/guidance/degradation‐kin.pdf.
Oregon State University Extension Service, 2003. What is Mushroom Compost?
http://extension.oregonstate.edu/gardening/what‐mushroom‐compost
Pennsylvania State University Extension. Center for Turfgrass Science. Using Spent Mushroom
Substrate (mushroom soil) as a Soil Amendment to Improve Turf. © 2018 The
Pennsylvania State University. As assessed December 7, 2017.
https://plantscience.psu.edu/research/centers/turf/extension/factsheets/mushroom‐
soil
Rinker, D.L. 2002. Handling and Using “Spent” Mushroom Substrate Around the World.
Mushroom Biology and Mushroom Products, Sanchez et al. (eds). UAEM. ISBN 968‐878‐
105‐3.
Sanchez, E. 2011. Vegetable Planting and Transplanting Guide. Penn State Extension. Available
at: https://extension.psu.edu/vegetable‐planting‐and‐transplanting‐guide. Accessed
February 28, 2019.
Snoo, G. R. and R. Luttik, 2004. Availability of pesticide‐treated seed on arable fields. Pest
Management Sciences. 60:501‐506.
Stehouwer et al., 2012. R. Stehouwer, M. Hall, D. Beyer, M. Hautau, J. Banfill. Mushroom
Compost Feedstock Production on Degraded Mined Land Reclaimed with Spent
Mushroom Compost. The Pennsylvania State University and Berks County Cooperative
Extension. http://www.mushroomcompost.org/files/theme/mined_land.pdf
University of Hertfordshire, 2019. PPDB: Pesticide Properties Database.
https://sitem.herts.ac.uk/aeru/ppdb/en/index.htm. Accessed February 25, 2019.
USEPA. 2004 Government Printing Office. Overview of the Ecological Risk Assessment Process in
the Office of Pesticide Programs. January 23, 2004. Environmental Fate and Effects
Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. Available
at https://www.epa.gov/sites/production/files/2014‐11/documents/ecorisk‐
overview.pdf.

45
USEPA, 2006. Review of New Use for Thiabendazole (Mertect 340‐F) as a Seed Treatment on Dry
Peas. DP Barcodes 315436 and 322581. Environmental Fate and Effects Division, Office
of Pesticide Programs. April 13, 2006.
USEPA. 2009. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and
Transport of Pesticides, Version 2.1. Environmental Fate and Effects Division. Office of
Pesticide Programs. U.S. Environmental Protection Agency. Available at
hhttps://www.epa.gov/pesticide‐science‐and‐assessing‐pesticide‐risks/guidance‐
selecting‐input‐parameters‐modeling.
USEPA. 2010a Guidance for Reporting on the Environmental Fate and Transport of the Stressors
of Concern in the Problem Formulation for Registration Review, Registration Review Risk
Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and
Other Relevant Risk Assessments. January 25, 2010. Environmental Fate and Effects
Division. Office of Chemical Safety and Pollution Prevention. U.S. Environmental
Protection Agency. Available at
http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endanger
ed_species_reregistration_workgroup/esa_reporting_fate.htm.
USEPA. 2010b. WQTT Advisory Note Number 9: Temperature Adjustments for Aquatic
Metabolism Inputs to EXAMs and PE5. Memorandum From D. F. Young to Water Quality
Tech Team. September 21, 2010. Environmental Fate and Effects Division. Office of
Chemical Safety and Pollution Prevention. U.S. Environmental Protection Agency.
Available at
http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/water_qu
ality_tech_team/wqtt_temp_adjust_exams_pe5.htm.
USEPA, 2010c. Environmental Fate and Ecological Risk Assessment for the Proposed Section 3
New Use of Thiabendazole on Field corn, Sweet corn, and Popcorn. DP Barcode 363978.
Environmental Fate and Effects Division, Office of Pesticide Programs. January 6, 2010.
USEPA. 2011a. Guidance for Using Non‐Definitive Endpoints in Evaluating Risks to Listed and
Non‐listed Animal Species. Memorandum From D. J. Brady to E. F. a. E. Division. May
10, 2011. Environmental Fate and Effects Division. Office of Chemical Safety and
Pollution Prevention. U.S. Environmental Protection Agency. Available at
http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endanger
ed_species_reregistration_workgroup/esa_non_definitive_endpoints.htm.
USEPA. 2011b. Acres Planted per Day and Seeding Rates of Crops Grown in the United States.
Memorandum from the Biological and Economic Analysis Division to the Health Effects
Division and Environmental Fate and Effects Division. Office of Pesticide Programs.
March 24, 2011.
USEPA. 2012. Standard Operating Procedure for Using the NAFTA Guidance to Calculate
Representative Half‐life Values and Characterizing Pesticide Degradation. November 30,
46
2012. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S.
Environmental Protection Agency. Available at
http://www.epa.gov/oppefed1/ecorisk_ders/degradation_kinetics/NAFTA_Degradation
_Kinetics.htm.
USEPA. 2013a. Thiobendazole (060101): Screening Level Usage Analysis. Biological Economic
and Analysis Division. February 22, 2013.
USEPA. 2013b. Guidance for Using PRZM‐GW in Drinking Water Exposure Assessments.
December 11, 2012. Environmental Fate and Effects Division. Office of Pesticide
Programs. U.S. Environmental Protection Agency. Available at
http://www.epa.gov/oppefed1/models/water/przm_gw/wqtt_przm_gw_guidance.htm.
USEPA. 2013c. Guidance on Modeling Offsite Deposition of Pesticides Via Spray Drift for
Ecological and Drinking Water Assessment. Environmental Fate and Effects Division.
Office of Pesticide Programs. Office of Chemical Safety and Pollution Prevention. U.S.
Environmental Protection Agency. Available at
http://www.regulations.gov/#!docketDetail;D=EPA‐HQ‐OPP‐2013‐0676.
USEPA. 2014a. Problem Formulation for the Ecological Risk and Drinking Water Exposure
Assessments to be Conducted in Support of the Registration Review of Thiabendazole
and Its Hypophosphite Salt. DP Barcode 412248. Environmental Fate and Effects
Division. Office of Pesticide Programs. March 18, 2014.
USEPA. 2014b Development of Community Water System Drinking Water Intake Percent
Cropped Area Adjustment Factors for use in Drinking Water Exposure Assessments:
2014 Update. 9/9/14. Environmental Fate and Effects Division. Office of Chemical Safety
and Pollution Prevention. U.S. Environmental Protection Agency. Available at
https://www.epa.gov/pesticide‐science‐and‐assessing‐pesticide‐risks/development‐
community‐water‐system‐drinking‐water.
USEPA. 2014c. Guidance for Addressing Unextracted Residues in Laboratory Studies.
Memorandum From to E. F. a. E. Division. September 12, 2014. Environmental Fate and
Effects Division. Office of Pesticide Programs. Office of Chemical Safety and Pollution
Prevention. Available at
http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/environm
ental_fate_tech_team/Unextracted_Residues_in_Lab_Studies.htm.
USEPA. 2014d. EFED Risk Assessment for the Proposed New Uses of Thiabendazole as a Seed
Treatment for Several Crop Groups, and an Increased Application Rate for Soybean Seed
Treatment. DP Barcode 410836. Environmental Fate and Effects Division. Office of
Pesticide Programs. April 10, 2014.

47
USEPA. 2016a. Risk Assessment for the Proposed New Uses of Thiabendazole as a Seed
Treatment on Legume Vegetables (Crop Groups 6 and 7). DP Barcode 428564.
Environmental Fate and Effects Division. Office of Pesticide Programs. March 29, 2016.
USEPA. 2016b. Refinements for Risk Assessment of Pesticide Treated Seeds – Interim Guidance.
Memoeandum from Donald Brady, Dirctor, the Environmental Fate and Effects Division
(EFED) to the staff of EFED. March 31,2016.
USEPA. 2018. PRD and EFED Efforts to Meet Registration Review Goals by Ensuring Effective
Planning Dialogue and Collaboration. Memorandum from the Environmental Fate and
Effects Division (EFED) and the Pesticide Re‐evaluation Division (PRD) to the staff of
EFED and PRD. March 9, 2018.
USEPA. 2018b. United States Environmental Protection Agency, Drinking Water Assessment for
the Registration Review of Thiabendazole, October 11, 2018. DP Barcode: 449263.
USEPA and Health Canada. 2013 Guidance for Selecting Input Parameters for Modeling
Pesticide Concentrations in Groundwater Using the Pesticide Root Zone Model. Version
1. October 15, 2012. Environmental Fate and Effects Division. Office of Pesticide
Programs. U.S. Environmental Protection Agency. Available at
http://www.epa.gov/oppefed1/models/water/przm_gw/wqtt_przm_gw_input_guidanc
e.htm.
USEPA, Health Canada, and California Department of Pesticide Regulations. 2014. Guidance for
Assessing Pesticide Risk to Bees. June 19, 2014. Environmental Fate and Effects Division.
Office of Pesticide Programs. U.S. Environmental Protection Agency. Available at
https://www.epa.gov/sites/production/files/2014‐
06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf.
USGS. 2015. National Water‐Quality Assessment Program (NAWQA). U.S. Geological Survey.
Available at http://water.usgs.gov/nawqa/.
Webster & Buckerfield, 2003. K. Webster, J. Buckerfield. Spent Mushroom Compost for
Viticulture. The Australian & New Zealand Grapegrower & Winemaker. Annual Technical
Issue, 2003.

14 Referenced MRIDs

A. Environmental Fate and Chemistry


161-1 Hydrolysis
MRID Citation Reference

48
122852 Wolf, F. (1972) Letter sent to Buck dated Aug 29, 1972: TBZ sugar beets pesticide: Project
No. 5734 0360. (Unpublished study received Jan 28, 1972 under 2F1237; submitted by
Merck & Co., Inc., Rahway, NJ; CDL:094101-D)
123315 WARF Institute, Inc. (1976) Environmental Chemistry: Hydrolysis of Radiolabelled
Thiabendazole in Aqueous Solutions. (Unpublished study received Aug 4, 1977 under 618-
75; submitted by Merck & Co., Inc., Rahway, NJ; CDL:232424-C)

WARF Institute, Inc. (1976) Environmental Chemistry: Photochemical Degrada-tion of


123316 Thiabendazole. (Unpublished study received Aug 4, 1977 under 618-75; submitted by
Merck & Co., Inc., Rahway, NJ; CDL:232424-D)
146781 Warf Institute, Inc. (1976) Environmental Chemistry Hydrolysis of Radiolabeled
Thiabendazole in Aqueous Solutions: Report a. Un- published report. 128 p.
41265301 Kabler, K.; Dykes, J. (1989) Hydrolysis as a Function of pH at 25 Degrees| C of Carbon
14|-Thiabendazole: ABC Final Report #37636. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 309 p.
92183026 Vanden Heuvel, W. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41265301.
Hydrolysis a Function of pH at 25° of [Carbon-14]- pH at 25° of [Carbon-14]-
Thiabendazole: Project 37636. Prepared by Analytical Bio-Chemistry Laboratories Inc.. 10
p.
161-2 Photodegradation - Water
MRID Citation Reference

146780 Warf Institute, Inc. (1976) Environmental Chemistry Photochemical Degradation of


Thiabendazole: Report b. Unpublished report. 74 p.
123316 WARF Institute, Inc. (1976) Environmental Chemistry: Photochemical Degradation of
Thiabendazole. (Unpublished study received Aug 4, 1977 under 618-75; submitted by
Merck & Co., Inc., Rahway, NJ; CDL:232424-D)
41258203 Kabler, K.; Dykes, J. (1989) Determination of the Photolysis Rate of [Carbon - 14]-
See Thiabendazole in pH 5 Buffered Solution at 25 °C: Project ID 37637. Unpublished study
41265101 prepared by Analytical Bio-Chemistry Laboratories, Inc. 743 p.
41265101 Kabler, K.; Dykes, J. (1989) Determination of the Photolysis Rate of (Carbon - 14)-
Thiabendazole in pH 5 Buffered Solution at 25 [Degree] C.: ABC Final Report #37637.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 576 p.
43328305 Flynn, J. (1994) Determination of the Aqueous Photolysis Rate of (carbon 14)-
Thiabendazole: Final Report: Lab Project Number: 41285. Unpublished study prepared by
ABC Labs, Inc. 82 p.
92183027 Vanden Heuvel, W. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41265101.
Determination of the Photolysis Rate of [Carbon-14]- Thiabendazole in pH 5 Buffered
Solution at 25 [degrees]: [Carbon-14]- Thiabendazole Project 37637. Prepared by
Analytical Bio-Chemistry Laboratories. 11 p.
161-3 Photodegradation - Soil
MRID Citation Reference

49
70750 Chib, J.S.; North, S.P.; Harrison, S.L. (1980) Chloramben (3-Amino- 2,5-dichlorobenzoic
Acid) Hydrolytic Degradation Studies: Project No. 00010121/780A. (Unpublished study
received Feb 18, 1981 under 264-138; submitted by Union Carbide Agricultural Products
Co., Inc., Ambler, Pa.; CDL:244443-C)
120017 Merck, Sharp & Dohme (1971) Results of Tests on the Amount of Residue Remaining;
Including a Description of Analytical Methods: (Thiabendazole). (Compilation;
unpublished study received Aug 13, 1972 under 2F1237; CDL:091094-A)
123324 Schroeder, C. (1978) Photodegradation of Thiabendazole in Soil. (Unpublished study
received Jul 5, 1978 under 618-75; prepared by WARF Institute, Inc., submitted by Merck
& Co., Inc., Rahway, NJ; CDL:235632-B)
41397301 Dykes, J.; Kabler, K. (1990) Determination of the Photolysis Rate of Carbon-14
Thiabendazole on the Surface of Soil: (Revised Final Report): Lab Project Number:
37638. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 602 p.
41397302 Dykes, J. (1990) Determination of the Photolysis Rate of Carbon 14|-Thiabendazole on
the Surface of Soil Supplemental Data: Lab Project Number: 376381. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 32 p.
92183037 Vanden Heuvel, W. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41397301 and
Related MRIDs 41397302. Determination of the Photolysis Rate of [Carbon 14]-
Thiabendazole on the Surface of Soil: Project 37638. Prepared by Analytical Bio-
Chemistry Laboratories, Inc. 11 p.
162-1 Aerobic Soil Metabolism
MRID Citation Reference

123321 WARF Institute, Inc. (1976) Environmental Chemistry: Metabolic Fate of Radiolabeled
Thiabendazole in Soil: (Soil Metabolism): Report d. (Unpublished study received Aug 4,
1977 under 618-75; submitted by Merck & Co., Inc., Rahway, NJ; CDL:232423-A)
146782 Warf Institute, Inc. (1976) Metabolic Fate of Radiolabeled Thiabendazole in Soil (Soil
Metabolism): Report d. Unpublished report. 145 p.
41791201 Daly, D.; Williams, M. (1991) Aerobic Soil Metabolism of Carbon-14Thiabendazole: Final
Report: Lab Project Number: 37639. Unpublished study prepared by Analytical Bio-
Chemistry Laboratories, Inc. 1876 p.
162-1 Aerobic Soil Metabolism
MRID Citation Reference

122888 Steele, J.; Lechnir, R. (1979) Environmental Chemistry: Thiabendazole--Anaerobic


Aquatic Metabolism. Interim rept. C. (Unpublished study received Jul 31, 1979 under
618-75; prepared by Raltech Scientific Services, Inc., submitted by Merck & Co., Inc.,
Rahway, NJ; CDL:098855-A)

50
123321 WARF Institute, Inc. (1976) Environmental Chemistry: Metabolic Fate of Radiolabelled
Thiabendazole in Soil: (Soil Metabolism): Report d. (Unpublished study received Aug
4, 1977 under 618-75; submitted by Merck & Co., Inc., Rahway, NJ; CDL:232423-A)
123325 Schroeder, C. (1978) Effects of Soil Microflora and Algae on Thiabendazole.
(Unpublished study received Jul 5, 1978 under 618- 75; submitted by Merck & Co.,
Inc., Rahway, NJ; CDL:235633-A)
146782 Warf Institute, Inc. (1976) Metabolic Fate of Radiolabeled Thiabendazole in Soil (Soil
Metabolism): Report d. Unpublished report. 145 p.
41791201 Daly, D.; Williams, M. (1991) Aerobic Soil Metabolism of Carbon 14|-Thiabendazole:
Final Report: Lab Project Number: 37639. Un- published study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 1876 p.
162-2 Anaerobic Soil Metabolism
MRID Citation Reference

146782 Warf Institute, Inc. (1976) Metabolic Fate of Radiolabeled Thiabendazole in Soil (Soil
Metabolism): Report d. Unpublished report. 145 p.
41559601 Daly, D.; Williams, M. (1990) Anaerobic Soil Metabolism of Carbon-14Thiabendazole:
ABC final Report 37640. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 1062 p.
162-3 Anaerobic Aquatic Metabolism
MRID Citation Reference

122888 Steele, J.; Lechnir, R. (1979) Environmental Chemistry: Thiabendazole--Anaerobic


Aquatic Metabolism. Interim rept. C. (Unpublished study received Jul 31, 1979 under
618-75; prepared by Raltech Scientific Services, Inc., submitted by Merck & Co., Inc.,
Rahway, NJ; CDL:098855-A)
ACC244423 Thiabendazole Anaerobic Aquatic Metabolism, Report (final), Jan. 14, 1981, by
Raltech Scientic Services for Merck and Co., Rathway, NJ, Accession NO. 244423.
163-1 Leaching (Adsorption/Desorption)
MRID Citation Reference

70748 Chib, J.S.; North, S.P.; Harrison, S.L. (1980) Chloramben (3-Amino- 2,5-
dichlorobenzoic Acid) Adsorption and Desorption Studies: Project No. 10121/1080.
(Unpublished study received Feb 18, 1981 under 264-138; prepared in cooperation
with A & L Agric. Lab., Inc., submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL:244443-A)
70749 Chib, J.S.; North, S.P.; Harrison, S.L. (1980) Chloramben (2,5-Di- chloro-3-
aminobenzoic Acid) Leaching Studies: Project No. 00010121/780B. (Unpublished
study received Feb 18, 1981 un- der 264-138; prepared in cooperation with A & L
Agricultural Laboratories, Inc., submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL:244443-B)
51
117800 Lauber, J. (1970) Letter sent to B. Greenwald dated Jan 20, 1970: Soil study with
thiabendazole--review of Erwin and Borum study. (Unpublished study received Apr 21,
1970 under 0F0881; submitted by Merck & Co., Inc., Rahway, NJ; CDL:091522-A)
120631 Aharonson, N.; Kafkafi, U. (1975) Adsorption, mobility, and persistence of
thiabendazole and methyl 2-benzimidazolecarbamate in soils. J. Agric. Food Chem.
23(4):720-724. (Also In unpublished submission received Sep 27, 1979 under 4581-
340; sub- mitted by Agchem Div., Pennwalt Corp., Philadelphia, PA; CDL: 099006-L)
121795 Erwin, D.; Borum, D. (1970) Persistence of Thiabendazole in Soil. (Unpublished study
received 1970 under 0F0881; prepared by Univ. of California--Riverside, Dept. of
Plant Pathology, submitted by Merck & Co., Inc., Rahway, NJ; CDL:093178-B)
123300 Steele, J. (1979) Environmental Chemistry: Partition of Thiabendazole between Water
and Soils. (Unpublished study received Jul 31, 1979 under 618-75; prepared by
Raltech Scientific Serv- ices, Inc., submitted by Merck & Co., Inc., Rahway, NJ; CDL:
098856-A)
-- Mobility of Thiabendazole Aerobically Aged in Soil and Photodegraded Thiabendazole
Collin Schroeder and John Steele, WARF Institute, Inc.
123317
WARF Institute, Inc. (1976) Environmental Chemistry: Soil Leaching Study: Column
Method Radiolabeled Thiabendazole. (Unpublished study received Aug 4, 1977 under
618-75; submitted by Merck & Co., Inc., Rahway, NJ; CDL:232424-E)

146783 Warf Institute, Inc. (1976) Soil Leaching Study: Column Method Radio Labelled
Thiabendazole: Report c. Unpublished report. 90 p.
-- Thiabendazole Aerobically Aged in soil and Photodegraded Thiabendazole.
123323 Schroeder, C. (1978) Soil Mobility of Thiabendazole Aerobically Aged in Soil and
Photodegraded Thiabendazole. (Unpublished study received Jul 5, 1978 under 618-
75; prepared by WARF Institute, Inc., submitted by Merck & Co., Inc., Rahway, NJ;
CDL: 235632-A)
41170102 Dykes, J. (1989) "Soil Adsorption/Desorption with Thiabendazole": Project ID: Final
Report No. 37635. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 339 p.
92183038 Vanden Heuvel, W. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41170102.
Soil Adsorption/Desorption with Thiabendazole: Project 37635. Prepared by Analytical
Bio-Chemistry Labs. 12 p.
164-1 Terrestrial Field Dissipation
MRID Citation Reference

98889 Chevron Chemical Company (1979) Residue Data from Soil in Which Potato Tubers
Were Grown from Seed Pieces Treated with Orthocide-mertect 10-0.5 Seed
Protectant|. (Compilation; unpublished study received Sp 18, 1979 under 239-2474;
CDL:241044-A)

52
123301 Steele, J. (1979) Thiabendazole: Combined Field Dissipation and Water Dispersal
from Rice Paddies. (Unpublished study received Jul 31, 1979 under 618-75; prepared
by Raltech Scientific Services, Inc., submitted by Merck & Co., Inc., Rahway, NJ;
CDL: 098857-A)
123322 WARF Institute, Inc. (1976) Environmental Chemistry: Field Dissipation Studies:
Thiabendazole: Report e. (Unpublished study received Aug 4, 1977 under 618-75;
submitted by Merck & Co., Inc., Rahway, NJ; CDL:232423-B; 235632)
-- Supplement to Thiabendazole Field Dissipation Studies Collin Schroeder and John
Steele WARF Institute. Inc.
43187201 Jacobson, B. (1994) Terrestrial Field Dissipation for Thiabendazole in Wheat: Lab
Project Number: 618-360-92530: 37853-3. Unpublished study prepared by Qualls
Agricultural Labs. and ABC Labs., Inc. 178 p.
43187202 Jacobson, B. (1994) Terrestrial Field Dissipation for Thiabendazole in Soy-beans:
Lab Project Number: 618-360-92516: 38043. Unpublished study prepared by Agri-
Growth Research, Inc. and ABC Labs., Inc. 187 p.
43187203 Jacobson, B. (1994) Terrestrial Field Dissipation for Thiabendazole in Soybeans: Lab
Project Number: 618-360-92678: 38042. Unpublished study prepared by Research
Options, Inc. and ABC Labs., Inc. 177 p.

164-2 Aquatic Field Dissipation


MRID Citation Reference

122856 Interregional Research Project No. 4 (1974) Environmental Study on Thiabendazole|.


(Unpublished study received 1974 under 4E1478; CDL:095866-A)
123301 Steele, J. (1979) Thiabendazole: Combined Field Dissipation and Water Dispersal from
Rice Paddies. (Unpublished study received Jul 31, 1979 under 618-75; prepared by
Raltech Scientific Services, Inc., submitted by Merck & Co., Inc., Rahway, NJ; CDL:
098857-A)
164-5 Long-Term Soil Dissipation
MRID Citation Reference

146784 Warf Institute, Inc. (1976) Field Dissipation Studies: Thiabendazole: Report e.
Unpublished report. 337 p.
146785 Steele, J.; Schroeder, C.; Morton, S. (1977) Supplement to Thiabendazole Field
Dissipation Studies: Report e: Mertect 340-F. Unpublished report prepared by Warf
Institute, Inc. 241 p.
165-1 Confined Rotational Crop
MRID Citation Reference

53
42367801 Halls, T.; Sanson, D. (1992) Carbon-14 Thiabendazole Confined Accumulation on
Rotational Crops: Lab Project Number: 37727. Unpublished study prepared by ABC
Labs, Inc. 134 p.
-- Rotational Crop Residue studies. Report F summary
165-4 Bioaccumulation in Fish
MRID Citation Reference

41631801 Hirsch, M. (1990) Bioconcentration of Thiabendazole(2-(4-Thiozolyl) -1H-Benzimida-


zole) in Bluegill Sunfish, Lepomis macrochirus: Final Report: Lab Project Number: EN-
456-GWN004-1. Unpublished Study prepared by Eastman Kodak Co., Health and
Environ. Laboratories. 235 p.
42022701 Hirsch, M. (1991) Bioconcentration of Thiabendazole (2-(4-thiazolyl)-1H-
Benzimidazole) in Bluegill Sunfish, Lepomis macrochirus: Lab Project Number:
GWN009: 90-0313. Unpublished study prepared by Eastman Kodak Co. 267 p.
123320 WARF Institute, Inc. (1976) Environmental Chemistry: Accumulation and Dissipation of
Thiabendazole in Catfish. (Unpublished study received Aug 4, 1977 under 618-75;
submitted by Merck & Co., Inc., Rahway, NJ; CDL:232425-C)
Non-Guideline Study
MRID Citation Reference

97322 Hine, R.B.; Johnson, D.L.; Wenger, C.J. (1969) The persistency of two benzimidazole
fungicides in soil and their fungistatic activity against phymatotrichum omnivorum.
Phytopathology 59(Jun):798-801. (Also in unpublished submission received Dec 29,
1969 under 0F0936; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
Del.; CDL:093241-C)
121796 Lauber, J. (1970) Letter sent to B. Greenwald dated Jan 16, 1970: Soil study with
thiabendazole--review of articles by Hine et al. (Unpublished study received 1970 under
0F0881; submitted by Merck & Co., Inc., Rahway, NJ; CDL:093178-C)
123319 WARF Institute, Inc. (1974) Environmental Chemistry: Effect of Thiabendazole on Soil
Microorganisms. (Unpublished study received Aug 4, 1977 under 618-75; submitted by
Merck & Co., Inc., Rahway, NJ; CDL:232425-B)

123325 Schroeder, C. (1978) Effects of Soil Microflora and Algae on Thiabendazole.


(Unpublished study received Jul 5, 1978 under 618- 75; submitted by Merck & Co.,
Inc., Rahway, NJ; CDL:235633-A)
B. Ecological Effects Bibliography
71-1 Avian Single-Dose Oral Toxicity
MRID Citation Reference

54
123313 Fink, R.; Beavers, J.; Brown, R. (1977) Acute Oral LD50--Bobwhite Quail:
Thiabendazole: Project No. 105-119. Final rept. (Un- published study received Dec 5,
1977 under 618-88; prepared by Wildlife International Ltd. and Washington College,
submitted by Merck & Co., Inc., Rahway, NJ; CDL:232421-G)
137948 Fink, R.; Beavers, J.; Brown, R. (1977) Acute Oral LD50--Mallard Duck: Thiabendazole:
Project No. 105-118. Final rept. (Un- published study received Dec 5, 1977 under 618-
88; prepared by Wildlife International Ltd. and Washington College, submitted by Merck
& Co., Inc., Rahway, NJ; CDL:232421-H)
41025002 Grimes, J.; Jaber, M. (1989) Technical Thiabendazole: An Acute Oral Toxicity Study
with the Bobwhite: Final Report: Project. No. 105-138. Unpublished study prepared by
Wildlife International Ltd. 26 p.
92183004 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41025002. Technical
Thiabendazole: An Acute Oral Toxicity Study with the Bobwhite: Project No. 105-138.
Prepared by Wildlife International. 9 p.
122900 Fink, R.; Beavers, J.; Brown, R. (1978) Acute Oral LD50--Mallard Duck: Mertect LSP:
Project No. 105-126. Final rept. (Unpublished study received May 24, 1978 under 618-
84; prepared by Wildlife International Ltd. and Washington College, submitted by Merck
& Co., Inc., Rahway, NJ; CDL:234030-A)
123308 Fink, R.; Beavers, J.; Brown, R. (1977) Acute Oral LD50--Bobwhite Quail--Arbotect 20-
S: Project No. 105-115. Final rept. (Unpublished study received Dec 5, 1977 under 618-
88; prepared by Wildlife International Ltd. and Washington College, submitted by Merck
& Co., Inc., Rahway, NJ; CDL:232421-A)

71-2 Avian Dietary Toxicity


MRID Citation Reference

47899, Knott, W.B.; Johnston, C.D. (1968) Thiabendazole: Safety Evaluation on Bobwhite
117805 Quail. (Unpublished study received Aug 7, 1974 under 5F1537; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, N.J.; CDL:094556-G)
CDL:091522-F)
122827, Fink, R. (1973) Eight-day Dietary LC50--Mallard Ducks: Thiabendazole: Project No.
47900, 105-101. Final report. (Unpublished study received Oct 18, 1973 under 618-65;
107425 prepared by Truslow Farms, Inc., submitted by Merck & Co., Inc., Rahway, NJ;
CDL:008742-A)
122901 Fink, R.; Beavers, J.; Brown, R. (1978) Acute Oral LD50--Bobwhite Quail: Mertect LSP:
Project No. 105-125. Final rept. (Unpublished study received May 24, 1978 under 618-
84; prepared by Wildlife International Ltd. and Washington College, submitted by Merck
& Co., Inc., Rahway, NJ; CDL:234030-B)
122902 Fink, R.; Beavers, J.; Brown, R. (1978) – Eight-Day Dietary LC50-- Bobwhite Quail:
Mertect LSP: Project No. 105-123. Final rept. (Unpublished study received May 24,
1978 under 618-84; prepared by Wildlife International Ltd. and Washington College,
submitted by Merck & Co., Inc., Rahway, NJ; CDL:234030-C)

55
122903 Fink, R.; Beavers, J.; Brown, R. (1978) Eight-day Dietary LC50-- Mallard Duck: Mertect
LSP: Project No. 105-124. Final rept. (Unpublished study received May 24, 1978 under
618-84; prepared by Wildlife International Ltd. and Washington College, submitted by
Merck & Co., Inc., Rahway, NJ; CDL:234030-D)
123309 Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-- Mallard Duck: Arbotect
20-S: Project No. 105-116. Final rept. (Unpublished study received Dec 5, 1977 under
618-88; prepared by Wildlife International Ltd. and Washington College, submitted by
Merck & Co., Inc., Rahway, NJ; CDL:232421-B)
123310 Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-- Bobwhite Quail:
Arbotect 20-S: Project No. 105-114. Final rept. (Unpublished study received Dec 5,
1977 under 618-88; prepared by Wildlife International Ltd. and Washington College,
submitted by Merck & Co., Inc., Rahway, NJ; CDL:232421-C)
123314 Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-- Bobwhite Quail:
Thiabendazole: Project No. 105-117. Final rept. (Unpublished study received Dec 5,
1977 under 618-88; prepared by Wildlife International Ltd. and Washington College,
submitted by Merck & Co., Inc., Rahway, NJ; CDL:232421-I)

41025003 Grimes, J.; Jaber, M. (1989) Technical Thiabendazole: A Dietary LC50 Study with the
Bobwhite: Proj. No. 105-136. Unpublished study prepared by Wildlife International Ltd.
29 p.
41025004 Grimes, J.; Jaber, M. (1989) Technical Thiabendazole: A Dietary LC50 Study with the
Mallard: Proj. No. 105-137. Unpublished study prepared by Wildlife International Ltd. 28
p.
92183005 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41025003. Technical
Thiabendazole, A Dietary LC50 Study with the Bobwhite: Project No. 105-136. Prepared
by Wildlife International. 9 p.
92183006 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41025004. Technical
Thiabendazole, A Dietary LC50 Study with the Mallard: Project No. 105-137. Prepared
by Wildlife International. 9 p.
71-4 Avian Reproduction
MRID Citation Reference

123327 Fink, R.; Beavers, J.; Brown, R. (1978) One-generation Reproduction Study--Bobwhite
235974 Quail: Thiabendazole 98.5% Technical: Project No. 105-120. Final rept. (Unpublished
study received Nov 21, 1978 under 618-75; prepared by Wildlife International Ltd. and
Washington College, submitted by Merck & Co., Inc., Rahway, NJ; CDL:235974-A)
123328 Fink, R.; Beavers, J.; Brown, R. (1978) One-generation Reproduction Study--Mallard
Duck: Thiabendazole 98.5% Technical: Project No. 105-121. Final rept. (Unpublished
study received Nov 21, 1978 under 618-75; prepared by Wildlife International Ltd. and
Washington College, submitted by Merck & Co., Inc., Rahway, NJ; CDL:235974-B)
72-1 Acute Toxicity to Freshwater Fish
MRID Citation Reference

56
47897 Knott, W.B.; Johnston, C.D. (1968) Thiabendazole: Safety Evaluation on Bluegill Sunfish.
(Unpublished study received Aug 7, 1974 under 5F1537; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, N.J.; CDL: 094556-E)

Knott, W.; Johnston, C. (1968) Thiabendazole: Safety Evaluation on Rainbow Trout.


117803 (Unpublished study received Apr 21, 1970 under 0F0881; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, NJ; CDL:091522-D)
117804 Knott, W.; Johnston, C. (1968) Thiabendazole: Safety Evaluation on Bluegill Sunfish.
123304, (Unpublished study received Apr 21, 1970 under 0F0881; prepared by Woodard
128222 Research Corp., submitted by Merck & Co., Inc., Rahway, NJ; CDL:091522-E)
123304 Knott, W.; Johnston, C. (1968) Thiabendazole Safety Evaluation on Bluegill Sunfish.
100340 (Unpublished study received Nov 27, 1968 under 618-66; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, NJ; CDL:100340-B)
47898 Knott, W.B.; Johnston, C.D. (1968) Thiabendazole: Safety Evaluation on Rainbow Trout.
094556 (Unpublished study received Aug 7, 1974 under 5F1537; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, N.J.; CDL:094556-F)
117803 Knott, W.; Johnston, C. (1968) Thiabendazole: Safety Evaluation on Rainbow Trout.
(Unpublished study received Apr 21, 1970 under 0F0881; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, NJ; CDL:091522-D)
122905 Vilkas, A. (1977) The Acute Toxicity of Mertect LSP to the Rainbow Trout, Salmo
gairdneri Richardson: UCES Project # 11506-42-05. (Unpublished study received May
24, 1978 under 618-84; prepared by Union Carbide Corp., submitted by Merck & Co.,
Inc., Rahway, NJ; CDL:234030-F)
122906 Vilkas, A. (1977) The Acute Toxicity of Mertect LSP to the Bluegill Sunfish, Lepomis
macrochirus Rafinesque: UCES Project #11506-42- 04. (Unpublished study received
May 24, 1978 under 618-84; prepared by Union Carbide Corp., submitted by Merck &
Co., Inc., Rahway, NJ; CDL:234030-G)
123311, Knott, W.; Johnston, C. (1971) Metasol TK-100, 20% Solution and 2-(4'Thiazolyl)
122822 Benzimidazole Safety Tests in Rainbow Trout. (Unpublished study received Dec 5, 1977
under 619-88; prepared by Woodard Research Corp., submitted by Merck & Co., Inc.,
Rahway, NJ; CDL:232418-D)
126631, Knott, W.; Johnson, C. (1971) Metasol TK-100, 20% Solution and 2-(4'Thiazolyl)-
123311 benzimidazole Safety Tests in Rainbow Trout. (Unpublished study received Mar 11, 1983
under 10445-31; pre- pared by Woodard Research Corp., submitted by Calgon Corp.,
Pittsburgh, PA; CDL:249806-G)
41025005 Beglinger, J.; O'Boyle, R. (1989) Acute Aquatic Effects of Thiabendazole on the Rainbow
Trout, Salmo gairdneri: Study No. EN-412-GWN001-2. Unpublished study prepared by
Eastman Kodak Co. 58 p.
41025006 Beglinger, J.; O'Boyle, R. (1989) Acute Aquatic Effects of Thiabendazole on the Bluegill
Sunfish, Lepomis macrochirus: Study No. EN-413-GWN001-2. Unpublished study
prepared by Eastman Kodak Co. 55 p.

57
42477701 Holmes, C.; Swigert, J.; Smith, G. (1992) Thiabendazole: A 90-hour Static Acute Toxicity
Test with the Bluegill Lepomis Macrochirus|: Lab Project Number: 105A-118A.
Unpublished study prepared by Wildlife Intl. Ltd. 42 p.
92183007 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41025006. Acute
Aquatic Effects of Thiabendazole (Sponsor Product No. 47982) on the Bluegill Sunfish
Lepomis macrochirus: Study No. EN-413-GWN001-2. Prepared by Easman Kodak,
Health and Environmental Laboratories. 12 p.
92183009 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41025005. Acute
Aquatic Effects of Thiabendazole (Sponsor Product No. 47982) on the Rainbow Trout,
Salmo gairdneri: Study No. EN-412-GWN001-2. Prepared by Eastman Kodak Co. Health
and Environmental Lab. 9 p.
72-2 Acute Toxicity to Freshwater Invertebrates
MRID Citation Reference

122904 Vilkas, A. (1978) The Acute Toxicity of Mertect LSP to the Water Flea--Daphnia magna
Straus: UCES Project # 11506-42-06. (Unpublished study received May 24, 1978 under
618-84; prepared by Union Carbide Corp., submitted by Merck & Co., Inc., Rahway, NJ;
CDL:234030-E)
123326 Vilkas, A. (1977) The Acute Toxicity of Thiabendazole Technical to the Water Flea
Daphnia magna Straus: UCES Proj. # 11506-42- 02. (Unpublished study received Jul 5,
1978 under 618-75; prepared by Union Carbide Corp., submitted by Merck & Co., Inc.,
Rahway, NJ; CDL:235634-D)
41709401 Holmes, C.; Bellantoni, D.; Peters, G. (1990) Thiabendazole: A 48-Hour Flow-through
Acute Toxicity Test with Cladoceran (Daphnia magna): Final Report: Lab Project
Number: 105A-101. Unpublished study prepared by Wildlife International Ltd. 129 p.

40789802 LeBlanc, G.; Mastone, J.; Surprenant, D. (1981) The Chronic Toxicity of Mertect
Fungicide to the Water Flea (Daphnia magna): Supplement to MRID 94645: Project ID.
BW-81-6-900. Unpublished study prepared by EG & G Bionomics. 6 p.
123312 Vilkas, A. (1977) The Acute Toxicity of Arbotect 20-S to the Water Flea Daphnia magna
Straus: UCES Project # 11506-42-03. (Unpublished study received Dec 5, 1977 under
618-88; prepared by Union Carbide Corp., submitted by Merck & Co., Inc., Rahway, NJ;
CDl:232421-F)

72-3 Acute Toxicity to Estuarine/Marine Organisms


MRID Citation Reference

41192002 Surprenant, D. (1989) Acute Toxicity of Thiabendazole to Mysid Shrimp (Mysidopsis


bahia) Under Flow-through Conditions: SLS Study No. 359.0888.6105.515: Report No.
89/1/2955. Unpublished study prepared by Springborn Life Sciences, Inc. 45 p.
41192003 Surprenant, D. (1989) Acute Toxicity of Thiabendazole to Sheepshead Minnow
(Cyprinodon variegatus) under Flow-through Conditions: SLS Study No.

58
359.0888.6106.505: Report No. 89-3-2957. Unpublished study prepared by Springborn
Life Sciences, Inc. 40 p.
41192004 Surprenant, D. (1989) Acute Toxicity of Thiabendazole to Eastern Oysters
(Crassostrea virginica) Under Flow-Through Conditions: SLS Study No.
359.0888.6107.504: Report No. 89-5-2986. Unpublished study prepared by Springborn
Life Sciences, Inc. 51 p.
92183008 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41192003. Acute
Toxicity of Thiabendazole to Sheepshead Minnow (Cyprinodon variegatus) under Flow-
through Conditions: Study No. 359.0888. 6106.505. Prepared by Eastman Kodak,
Health and Environmental Laboratories. 12 p.
92183010 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41192004. Acute
Toxicity of Thiabendazole to Eastern Oysters (Crassostrea virginica) under Flow-
through Conditions: Study #359-888.6107.504. Prepared by Springborn Like Sciences,
Inc. 12 p.
92183011 Wislocki, P. (1990) Merck & Co. Inc. Phase 3 Summary of MRID 41192002. Acute
Toxicity of Thiabendazole to Mysid Shrimp (Mysidopsis bahia) under Flow-through
Conditions: Study No. 359.0888.6105.515. Prepared by Springborn Life Sciences, INC.
12 p.
72-4 Early-Life Stage / Life-Cycle Toxicity to Fish andAquatic
Invertebrates
MRID Citation Reference

47897 Knott, W.B.; Johnston, C.D. (1968) Thiabendazole: Safety Evaluation on Bluegill
Sunfish. (Unpublished study received Aug 7, 1974 under 5F1537; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, N.J.; CDL:094556-E)
47898 Knott, W.B.; Johnston, C.D. (1968) Thiabendazole: Safety Evaluation on Rainbowq
Trout. (Unpublished study received Aug 7, 1974 unde 5F1537; prepared by Woodard
Research Corp., submitted by Merck & Co., Inc., Rahway, N.J.; CDL:094556-F)
LeBlanc, G.A.; Mastone, J.D.; Wilson, B.F. (1981) The Toxicity of Mertect Fungicide to
94644 Fathead Minnow (~Pimephales promelas~) Embryos and Larvae: Report #BW-81-5-
890. (Unpublished study received Jan 19, 1982 under 618-75; prepared by EG & G
Bionomics, submitted by Merck & Co., Inc., Rahway, N.J.; CDL: 246711-A)
94645 LeBlanc, G.A.; Mastone, J.D.; Suprenant, D.C.; et al. (1981) The Chronic Toxicity of
Mertect Fungicide to the Water Flea (Daphnia magna): Report #BW-81-6-900.
(Unpublished study received Jan 19, 1982 under 618-75; prepared by EG & G
Bionomics, submitted by Merck & Co., Inc., Rahway, N.J.; CDL: 246711-B)
97969 LeBlanc, G.A.; Mastone, J.D.; Wilson, B.F. (1982) The Toxicity of Mertect Fungicide to
Rainbow Trout (~Salmo gairdneri~) Embryos and Larvae: Report #BW-82-1-1099.
(Unpublished study received Mar 25, 1982 under 618-75; prepared by EG & G,
Bionomics, submitted by Merck & Co., Inc., Rahway, N.J.; CDL:247102-A)
Holmes, C.; Swigert, J. (1992) Thiabendazole: An Early Life-Stage Toxicity Test with the
42508901 Fathead Minnow (Pimephales promelas): Lab Project Number: 105A-111. Unpublished
study prepared by Wildlife International Ltd. 58 p.
59
40789802 LeBlanc, G.; Mastone, J.; Surprenant, D. (1981) The Chronic Toxicity of
Mertect Fungicide to the Water Flea (Daphnia magna): Supplement to
MRID 94645: Project ID. BW-81-6-900. Unpublished study prepared by
EG & G Bionomics. 6 p.
171-4A2 Nature of the Residue in Plants
MRID Citation Reference

Verma, R.K.; Vyas, S.C. (1976) Uptake, translocation and persistence of five systemic
5001172
fungicides in gram seedlings. Pesticides 10(12):21-24.
Bolkan, H.A.; Milne, K.S. (1975) Systemic uptake of four fungicides by potato plants.
5002793
Plant Disease Reporter 59(3):214-218.

850.1075 Acute Toxicity to Fish, Freshwater and Marine


MRID Citation Reference

50079102 Jeram, L. (2016) o-Phenylphenol, o-Phenylphenol, Sodium Salt, and o-Phenylphenol,


Potassium Salt: Waiver Requests: GDCI Response. Project Number: 2016/OPP,
K/001024/039, K/001024/047. Unpublished study prepared by Lanxess Corporation
and Dow Chemical Company. 11p.
850.1300 Chronic Toxicity to the Daphnid
MRID Citation Reference

50079101 Bruns (2001) Preventol Extra: Daphnia magna Reproduction Test. Project Number:
1092/A/01/DL. Unpublished study prepared by Bayer AG. 25p.
50079102 Jeram, L. (2016) o-Phenylphenol, o-Phenylphenol, Sodium Salt, and o-Phenylphenol,
Potassium Salt: Waiver Requests: GDCI Response. Project Number: 2016/OPP,
K/001024/039, K/001024/047. Unpublished study prepared by Lanxess Corporation
and Dow Chemical Company. 11p.
850.1400 Early-Life Stage Toxicity to Fish
MRID Citation Reference

50079102 Jeram, L. (2016) o-Phenylphenol, o-Phenylphenol, Sodium Salt, and o-Phenylphenol,


Potassium Salt: Waiver Requests: GDCI Response. Project Number: 2016/OPP,
K/001024/039, K/001024/047. Unpublished study prepared by Lanxess Corporation
and Dow Chemical Company. 11p.
850.3020 Acute Contact Toxicity to the Honey Bee
MRID Citation Reference

60
48996305 Kennedy, P.; Hargreaves, N. (2003) MK360 (Thiabendazole) - Acute Contact and Oral
Toxicity of Technical Material to the Honeybee (Apis mellifera) (Including Minor Report
Amendment): Final Report. Project Number: TK0119342/OCR, RJ3396B. Unpublished
study prepared by Syngenta Jealotts Hill International Research Centre. 28p.
850.3300 Modified Activated Sludge, Respiration Inhibition Test
MRID Citation Reference

49747402 Kolk, J. (1998) MK 360 B (Thiabendazole): Activated Sludge, Respiration Inhibition


Test: Final Report. Project Number: 98/227/1047, 1047/025/790, TK0283700. Study
prepared by Springborn Laboratories (Europe) AG. 45p.
850.4100 Terrestrial Plant Toxicity, Tier 1 (Seeding Emergence)
MRID Citation Reference

48996306 Martin, J. (2012) Thiabendazole - Seedling Emergence Test: Final Report. Project
Number: TK0052144/OCR, 1781/6808. Unpublished study prepared by Smithers
Viscient Laboratories. 118p.
850.4150 Terrestrial Plant Toxicity, Tier 1 (Vegetative Vigor)
MRID Citation Reference

48996307 Martin, J. (2012) Thiabendazole - Vegetative Vigor Test: Final Report. Project Number:
TK0052143/OCR, 1781/6809. Unpublished study prepared by Smithers Viscient
Laboratories. 108p.
850.4225 Seedling Emergence Toxicity, Tier II
MRID Citation Reference

48996306 Martin, J. (2012) Thiabendazole - Seedling Emergence Test: Final Report. Project
Number: TK0052144/OCR, 1781/6808. Unpublished study prepared by Smithers
Viscient Laboratories. 118p.
850.4250 Vegetative Vigor Toxicity, Tier II
MRID Citation Reference

48996307 Martin, J. (2012) Thiabendazole - Vegetative Vigor Test: Final Report. Project Number:
TK0052143/OCR, 1781/6809. Unpublished study prepared by Smithers Viscient
Laboratories. 108p.
850.4400 Aquatic Plant Toxicity Using Lemna spp.
MRID Citation Reference

48996308 Soucy, K. (2012) Thiabendazole - 7-Day Toxicity Test with Duckweed (Lemna gibba):
Final Report. Project Number: TK0052142/OCR, 1781/6811. Unpublished study
prepared by Smithers Viscient Laboratories. 68p.
61
50079102 Jeram, L. (2016) o-Phenylphenol, o-Phenylphenol, Sodium Salt, and o-Phenylphenol,
Potassium Salt: Waiver Requests: GDCI Response. Project Number: 2016/OPP,
K/001024/039, K/001024/047. Unpublished study prepared by Lanxess Corporation
and Dow Chemical Company. 11p.
850.4500 Algal Toxicity
MRID Citation Reference

49928201 Arnie, J.; Zhang, L.; Porch, J.; et al. (2016) Thiabendazole - A 96-Hour Toxicity Test
with the Freshwater Diatom (Navicula pelliculosa): Final Report. Project Number:
528P/144, TK0211514. Unpublished study prepared by Wildlife International, Ltd. 52p.
49928203 Arnie, J.; Zhang, L.; Porch, J.; et al. (2016) Thiabendazole - A 96-Hour Toxicity Test
with the Marine Diatom (Skeletonema costatum): Final Report Amendment 1. Project
Number: 528P/145, TK0211515. Unpublished study prepared by Wildlife International,
Ltd. 50p.
49928204 Zhang, L.; Martin, K.; Bodle, E. (2016) Thiabendazole: Analytical Method Verification
for the Determination of Thiabendazole in Saltwater Algal Medium: Final Report.
Project Number: 528C/193, TK0283493. Unpublished study prepared by Wildlife
International, Ltd. 37p.
850.4550 Cyanobacteria (Anabaena flos-aquae) Toxicity
MRID Citation Reference

49928202 Arnie, J.; Zhang, L.; Porch, J.; et al. (2016) Thiabendazole - A 96-Hour Toxicity Test
with the Cyanobacteria (Anabaena flos-aquae): Final Report. Project Number:
528P/143, TK0211516. Unpublished study prepared by Wildlife International, Ltd. 51p.
850.5400 Algal Toxicity
MRID Citation Reference

49146601 Batscher, R. (2004) Thiabendazole (MK360) - A 96-Hour Algal Growth Inhibition Test
with Pseudokirchneriella subcapitata (Formerly Selenastrum capricornutum): Final
Report. Project Number: 853033, 2033694, TK0185578. Unpublished study prepared
by RCC, Ltd. 46p.
Non-Guideline Studies
MRID Citation Reference

48033008 Kojima, H.; Katsura, E.; Takeuchi, S.; et al. (2004) Screening for Estrogen and
Androgen Receptor Activities in 200 Pesticides by In Vitro Reporter Gene Assays
Using Chinese Hamster Ovary Cells. Environmental Health Perspectives 112(5):
524-531.
48033010 Nishihara, T.; Nishikawa, J.; Kanayama, T.; et al. (2000) Estrogenic Activities of 517
Chemicals by Yeast Two-Hybrid Assay. Journal of Health Science 46(4): 282-298.

62
48125701 Manabe, M.; Kanda, S.; Fukunaga, K.; et al. (2006) Evaluation of the Estrogenic
Activities of Some Pesticides and their Combinations Using MtT/Se Cell Proliferation
Assay. International Journal of Hygiene and Environmental Health 209:413-421.
5008969 Blume, R.R. Residues in Cow manure- non-target effects

63
APPENDIX A. ROCKS Table

Table A1. Chemical Names and Structures of Thiabendazole and its Transformation Products

64
APPENDIX B. Aquatic Modeling Input and Output

Aquatic modeling input parameters for generating EECs are displayed in Table B‐1. All PWC
scenarios that were modeled and application information are detailed in Table B‐2. Resulting
EECs are described in Table B‐3.

Table B‐1. Aquatic Modeling Input Parameters for Thiabendazole


Parameter (units) Value (s) Source Comments
MRID
KOC (mL/g) 7,343 Average of 4 values.
41170102
Water Column
Study
Metabolism Half‐life 0 No data available.
waived
(days) at 20°C
Benthic Metabolism MRIDs
Half‐life (days) at 0 0122888, Stable
20oC 00070753
Aqueous Photolysis MRID
1.2 at 40oC One measured value for parent.
Half‐life (days)@ pH 7 3328305
Rates of transformation were extrapolated resulting
Hydrolysis Half‐life MRID
0 in t½ (198 days @pH 7) far beyond the length of the
(days) 41265301
study (30 days)
Soil Half‐life (days) at MRID A 3x factor was applied to the one soil half‐life (688 x
2,064
20oC 41791201 3)
Foliar Half‐life 0 ‐‐ No Data
Molecular Weight
201.1 Calculated ‐‐
(g/mol)
Vapor Pressure (Torr) MRID
3.45 x 10‐9 ‐‐‐
at 25oC 48354601
Solubility in Water MRID
28 25oC and pH 7
(mg/L) 40947301

Table B‐2. PWC Scenario and Application Information for Thiabendazole


Date of App. Rate in # App. Application
Seed
Run Name Use Site PWC Scenario Initial lb a.i./A per Efficiency/
Treatment
App. (kg a.i./ha) Year Spray Drift

Wheat1 NDwheatSTD_+0

Wheat2 TXwheatOP.scn
Wheat, Δ*
0.15
Oat, Rye, ‐7 1 1 inch 1/0
(0.17)
Triticale (2.54cm)

Wheat3 ORwheatOP.scn

65
Date of App. Rate in # App. Application
Seed
Run Name Use Site PWC Scenario Initial lb a.i./A per Efficiency/
Treatment
App. (kg a.i./ha) Year Spray Drift

Legume 1 MSsoybeanSTD.scn

Legume 2 NCpeanutSTD.scn

Legume 3 ORsnbeansSTD.scn

Legume 4 MIbeansSTD.scn

Legume 5 WAbeansNMC.scn

Legume 6 Legumes ILbeansNMC.scn


(Soybean, Pea, ‐7
Legume 7 Alfalfa)
PAalfalfaOP.scn

Legume 8
TXalfalfaOP.scn

Legume 9
MNalfalfaOP.scn

Legume 10
NCalfalfaOP.scn

Legume 11
CAalfalfa_WirrigOP.scn

Legume 12
ILalfalfaNMC.scn
Ornamental1 TNnurserySTD_V2.scn
Ornamental2 ORnurserySTD_V2.scn
Ornamental3 NJnurserySTD_V2.scn
Ornamentals ‐7
Ornamental4 MInurserySTD_V2.scn
Ornamental5 FLnurserySTD_V2.scn
Ornamenta16 CAnurserySTD_V2.scn

Potato1 Root
Vegetables, NCSweetPotatoSTD.scn
‐14
Potato2 Potato, Sweet MEpotatoSTD.scn
Potato
Potato3 IDNpotato_WirrigSTD.scn
Brassica1 Brassica FLcabbageSTD.scn ‐5
Bulb
Vegetable1 GAOnion_WirrigSTD.scn
Bulb Bulb Vegetable
‐7
Vegetable2 CAonion_WirrigSTD.scn
Bulb
Vegetable3 MIAsparagusSTD.scn
Corn1 Corn (field, PAcornSTD.scn
‐7
Corn2 sweet, pop) OHCornSTD.scn

66
Date of App. Rate in # App. Application
Seed
Run Name Use Site PWC Scenario Initial lb a.i./A per Efficiency/
Treatment
App. (kg a.i./ha) Year Spray Drift
Corn3 NCcornESTD.scn
Corn4 MScornSTD.scn
Corn5 ILCornSTD.scn
Corn6 INCornSTD.scn
Corn7 IAcornstd.scn
Cucurbit
Vegetables1 FLcucumberSTD.scn
Cucurbit
Vegetables2 STXmelonNMC.scn
Cucurbit Cucurbit
‐7
Vegetables3 Vegetables NJmelonStd.scn
Cucurbit
Vegetables4 MOmelonStd.scn
Cucurbit
Vegetables5 MImelonStd.scn
Spinach1 Spinach CAlettuceSTD.scn ‐7
* Δ – The symbol in PWC that represents the pesticide distribution linearly increases with depth at the specified
depth

Table B‐3. Surface Water Estimated Environmental Concentrations for Thiabendazole


1‐in‐10 year EEC
Run Name1 Use PWC Scenario Water Column (µg/L)
1‐day 21‐day 60‐day
Wheat1 NDwheatSTD_+0 0.37 0.28 0.26
Wheat, Oat,
Wheat2 TXwheatOP.scn 0.66 0.47 0.41
Rye, Triticale
Wheat3 ORwheatOP.scn 0.21 0.16 0.15

Legume 1 MSsoybeanSTD.scn 0.67 0.48 0.43

Legume 2 NCpeanutSTD.scn 0.32 0.24 0.23


Legume 3 ORsnbeansSTD.scn 0.50 0.42 0.39
Legume 4 MIbeansSTD.scn 0.45 0.36 0.33
Legume 5 WAbeansNMC.scn 0.28 0.14 0.11
Legume
Legume 6 ILbeansNMC.scn 0.67 0.57 0.54
(Soybean,
Legume 7 Pea, Alfalfa) PAalfalfaOP.scn 0.35 0.27 0.25
Legume 8 TXalfalfaOP.scn 0.63 0.44 0.41
Legume 9 MNalfalfaOP.scn 0.20 0.14 0.13
Legume 10 NCalfalfaOP.scn 0.34 0.26 0.25
Legume 11 CAalfalfa_WirrigOP.scn 0.10 0.08 0.07
Legume 12 ILalfalfaNMC.scn 0.42 0.34 0.32
Ornamental1 Ornamentals TNnurserySTD_V2.scn 0.32 0.24 0.22

67
1‐in‐10 year EEC
Run Name1 Use PWC Scenario Water Column (µg/L)
1‐day 21‐day 60‐day
Ornamental2 ORnurserySTD_V2.scn 0.13 0.09 0.09
Ornamental3 NJnurserySTD_V2.scn 0.25 0.20 0.19
Ornamental4 MInurserySTD_V2.scn 0.24 0.20 0.19
Ornamental5 FLnurserySTD_V2.scn 0.37 0.25 0.22

Ornamenta16 CAnurserySTD_V2.scn 0.12 0.06 0.04

Potato1 Root NCSweetPotatoSTD.scn 0.38 0.30 0.27


Potato2 Vegetables, MEpotatoSTD.scn 0.42 0.38 0.36
Potato,
Sweet
Potato3 IDNpotato_WirrigSTD.scn 0.14 0.13 0.13
Potato

Brassica1 Brassica FLcabbageSTD.scn 0.54 0.40 0.38


Bulb
GAOnion_WirrigSTD.scn 0.40 0.28 0.24
Vegetable1
Bulb Bulb
CAonion_WirrigSTD.scn 0.05 0.04 0.04
Vegetable2 Vegetable
Bulb
MIAsparagusSTD.scn 0.09 0.05 0.04
Vegetable3
Corn1 PAcornSTD.scn 0.40 0.31 0.29
Corn2 OHCornSTD.scn 0.49 0.38 0.35
Corn3 NCcornESTD.scn 0.36 0.29 0.26
Corn (field,
Corn4 sweet, pop) MScornSTD.scn 0.95 0.67 0.63
Corn5 ILCornSTD.scn 0.55 0.44 0.42
Corn6 INCornSTD.scn 0.48 0.39 0.36
Corn7 IAcornstd.scn 0.39 0.28 0.26
Cucurbit
FLcucumberSTD.scn 0.76 0.56 0.54
Vegetables1
Cucurbit
STXmelonNMC.scn 0.80 0.55 0.48
Vegetables2
Cucurbit Cucurbit
NJmelonStd.scn 0.35 0.24 0.22
Vegetables3 Vegetables
Cucurbit
MOmelonStd.scn 0.44 0.33 0.31
Vegetables4
Cucurbit
MImelonStd.scn 0.22 0.17 0.16
Vegetables5

Spinach1 Spinach CAlettuceSTD.scn 0.65 0.47 0.43


Maximum EECs are in bold.

68
Below is an example output summary file from a single PWC aquatic modeling simulation on
wheat.

Estimated Environmental Concentrations for thiabendazole are presented in Table 1 for the
USEPA standard pond with the NDwheatSTD field scenario. A graphical presentation of the
year‐to‐year peaks is presented in Figure 1. These values were generated with the Pesticide
Water Calculator (PWC), Version 1.52. Critical input values for the model are summarized in
Tables 2 and 3.

This model estimates that about 0.33% of applied to the field eventually reaches the water
body. The main mechanism of transport from the field to the water body is by runoff (90.6% of
the total transport) followed by erosion (9.36%).

In the water body, pesticide dissipates with an effective water column half‐life of 215.7 days.
(This value does not include dissipation by transport to the benthic region; it includes only
processes that result in removal of pesticide from the complete system.) The main source of
dissipation in the water column is photolysis (effective average half‐life = 215.7 days).

In the benthic region, pesticide is stable. The vast majority of the pesticide in the benthic
region (99.87%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for Thiabendazole .


Peak (1‐in‐10 yr) 0.387
4‐day Avg (1‐in‐10 yr) 0.350
21‐day Avg (1‐in‐10 yr) 0.284
60‐day Avg (1‐in‐10 yr) 0.261
365‐day Avg (1‐in‐10 yr) 0.244
Entire Simulation Mean 0.164

69
Table 2. Summary of Model Inputs for Thiabendazole.
Scenario NDwheatSTD
Cropped Area Fraction 1
Koc (ml/g) 7343
Water Half‐Life (days) @ 25 °C 0
Benthic Half‐Life (days) @ 25 °C 0
Photolysis Half‐Life (days) @ 40 °Lat 1.2
Hydrolysis Half‐Life (days) 0
Soil Half‐Life (days) @ 25 °C 2064
Foliar Half‐Life (days)
Molecular Weight 201.1
Vapor Pressure (torr) 3.45E‐9
Solubility (mg/l) 28
Henry's Constant 0.0

Table 3. Application Schedule for Thiabendazole.


Date (Days Since Type Amount (kg/ha) Eff. Drift
Emergence)
‐7 Linearly increasing to 2.54 cm 0.17 1 0
Figure 1. Yearly Peak Concentrations

70
APPENDIX C. Example Model Output for Terrestrial Invertebrates (BeeREX Model)

Table 1. User inputs (related to exposure)


Description Value
Application rate 0.15
Units of app rate lb a.i./A
Application method seed treatment
Mass of tree vegetation (kg‐wet weight) 0.1
Are empirical residue data available? no

Table 2. Toxicity data


Description Value (µg a.i./bee)
Adult contact LD50 34
Adult oral LD50 4
Adult oral NOAEL 2.57
Larval LD50 213
Larval NOAEL 0.98

Table 3. Estimated concentrations in pollen and nectar


Application method EECs (mg a.i./kg) EECs (µg a.i./mg)
foliar spray NA NA
soil application NA NA
seed treatment 1 0.001
tree trunk NA NA

Table 4. Results (highest RQs)


Exposure Adults Larvae
Acute contact NA NA
Acute dietary 0.07 0.00
Chronic dietary 0.11 0.13

71
Table 4. Daily consumption of food, pesticide dose and resulting dietary RQs for all bees
Average age (in Nectar Pollen Total dose (µg
Life stage Caste or task in hive Jelly (mg/day) Acute RQ Chronic RQ
days) (mg/day) (mg/day) a.i./bee)
1 1.9 0 0 0.000019 8.9202E‐08 1.94E‐05
2 9.4 0 0 0.000094 4.4131E‐07 9.59E‐05
Worker 3 19 0 0 0.00019 8.9202E‐07 0.000194
4 0 60 1.8 0.0618 0.00029014 0.063061
5 0 120 3.6 0.1236 0.00058028 0.126122
Larval
Drone 6+ 0 130 3.6 0.1336 0.00062723 0.136327
1 1.9 0 0 0.000019 8.9202E‐08 1.94E‐05
2 9.4 0 0 0.000094 4.4131E‐07 9.59E‐05
Queen
3 23 0 0 0.00023 1.0798E‐06 0.000235
4+ 141 0 0 0.00141 6.6197E‐06 0.001439
Worker (cell cleaning and
0‐10 0 60 6.65 0.06665 0.0166625 0.025934
capping)
Worker (brood and queen
6 to 17 0 140 9.6 0.1496 0.0374 0.05821
tending, nurse bees)

Worker (comb building,


11 to 18 0 60 1.7 0.0617 0.015425 0.024008
cleaning and food handling)

Adult Worker (foraging for pollen) >18 0 43.5 0.041 0.043541 0.01088525 0.016942

Worker (foraging for nectar) >18 0 292 0.041 0.292041 0.07301025 0.113635
Worker (maintenance of
0‐90 0 29 2 0.031 0.00775 0.012062
hive in winter)
Drone >10 0 235 0.0002 0.2350002 0.05875005 0.09144
Queen (laying 1500
Entire lifestage 525 0 0 0.00525 0.0013125 0.002043
eggs/day)

72
APPENDIX D. Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA reviews
numerous studies to assess potential adverse outcomes from exposure to chemicals.
Collectively, these studies include acute, subchronic and chronic toxicity, including assessments
of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity.
These studies include endpoints which may be susceptible to endocrine influence, including
effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual
maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For
ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess
growth, developmental and reproductive effects in different taxonomic groups. As part of the
Draft Ecological Risk Assessment for Registration Review, EPA reviewed these data and selected
the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard
database. However, as required by FFDCA section 408(p), thiabendazole is subject to the
endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide
active and other ingredients) may have an effect in humans or wildlife similar to an effect
produced by a “naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.” The EDSP employs a two‐tiered approach to making the
statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to
identify the potential of a chemical substance to interact with the estrogen, androgen, or
thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are
found to have the potential to interact with E, A, or T hormonal systems will proceed to the
next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary
based on the available data. Tier 2 testing is designed to identify any adverse endocrine‐related
effects caused by the substance, and establish a dose‐response relationship between the dose
and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October
2009 and February 2010, EPA issued test orders/data call‐ins for the first group of 67 chemicals,
which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals
identified for EDSP screening was published on June 14, 2013[1] and includes some pesticides
scheduled for registration review and chemicals found in water. Neither of these lists should be
construed as a list of known or likely endocrine disruptors. Thiabendazole is not on List 1. For
further information on the status of the EDSP, the policies and procedures, the lists of
chemicals, future lists, the test guidelines and Tier 1 screening battery, please visit our
website[2].

[1]
See http://www.regulations.gov/#!documentDetail;D=EPA‐HQ‐OPPT‐2009‐0477‐0074 for the final second list of
chemicals.
[2]
Available: http://www.epa.gov/endo/

73
APPENDIX E. Listed Species

In November 2013, the EPA, along with the Services and the United States Department of
Agriculture (USDA), released a summary of their joint Interim Approaches for assessing risks to
endangered and threatened (listed) species from pesticides. The Interim Approaches were
developed jointly by the agencies in response to the National Academy of Sciences’ (NAS)
recommendations and reflect a common approach to risk assessment shared by the agencies as
a way of addressing scientific differences between the EPA and the Services. The NAS report[1]
outlines recommendations on specific scientific and technical issues related to the
development of pesticide risk assessments that EPA and the Services must conduct in
connection with their obligations under the ESA and FIFRA.

EPA received considerable public input on the Interim Approaches through stakeholder
workshops and from the Pesticide Program Dialogue Committee (PPDC) and State‐FIFRA Issues
Research and Evaluation Group (SFIREG) meetings. As part of a phased, iterative process for
developing the Interim Approaches, the agencies will also consider public comments on the
Interim Approaches in connection with the development of upcoming Registration Review
decisions. The details of the joint Interim Approaches are contained in the white paper Interim
Approaches for National‐Level Pesticide Endangered Species Act (ESA) Assessments Based on
the Recommendations of the National Academy of Sciences April 2013 Report[2], dated
November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the
Interim Approaches to assess the potential risks of pesticides to listed species and their
designated critical habitat, this ecological risk assessment for thiabendazole does not contain a
complete ESA analysis that includes effects determinations for specific listed species or
designated critical habitat. Although EPA has not yet completed effects determinations for
specific species or habitats, this assessment assumed, for all taxa of non‐target wildlife and
plants, that listed species and designated critical habitats may be present in the vicinity of the
application of thiabendazole. This assessment will allow EPA to focus its future evaluations on
the types of species where the potential for effects exists once the scientific methods being
developed by the agencies have been fully vetted. Once the agencies have fully developed and
implemented the scientific methodology for evaluating risks for listed species and their
designated critical habitats, these methods will be applied to subsequent analyses for
thiabendazole as part of completing this registration review.

[1]
Assessing Risks to Endangered and Threatened Species from Pesticides. Available at
http://www.nap.edu/catalog.php?record_id=18344
[2]
Available at http://www2.epa.gov/endangered‐species/assessing‐pesticides‐under‐endangered‐species‐
act#report

74
APPENDIX F. Calculated Application Rates

Table F1 provides calculated application rates (lb a.i./A) for seed treatments of representative
seed treatment crops. These rates were based on the maximum seed treatment rates (mg
a.i./seed) stated on the product labels and ranges of seed planting rates provided by the
Biological and Economic Analysis Division (USEPA 2011b)

Table F1. Calculated Application Rates (lb a.i./A) of Thiabendazole on Representative Crops
Seed Treatment Seeding Rate (seeds/A)1 Appl. Rate (mg ai/A) Rate (lb ai/A)
Rate
(mg ai/seed) Min Max Min Max Min Max
Alfalfa 0.004 3,405,000 3,405,000 13,620.0 13,620.0 0.0300 0.0300
Corn, Field 0.0726 24,200 40,250 1,756.9 2,922.2 0.0039 0.0064
Corn, Sweet 0.0726 13,068 59,739 948.7 4,337.1 0.0021 0.0096
Corn, Pop 0.0726 20,000 30,000 1,452.0 2,178.0 0.0032 0.0048
Barley 0.03 1,222,000 1,300,000 36,660.0 39,000.0 0.0808 0.0860
Oats 0.03 1,305,000 1,305,000 39,150.0 39,150.0 0.0863 0.0863
Rye 0.03 1,962,000 1,962,000 58,860.0 58,860.0 0.1298 0.1298
Triticale 0.03 1,744,000 1,744,000 52,320.0 52,320.0 0.1153 0.1153
Wheat 0.03 600,000 1,350,000 18,000.0 40,500.0 0.0397 0.0893
Broccoli 0.002 8,297 210,845 16.6 421.7 3.66E‐05 9.30E‐04
Cabbage 0.002 7,260 98,010 14.5 196.0 3.20E‐05 4.32E‐04
Onion 0.002 87,120 124,528 174.2 249.1 3.84E‐04 5.49E‐04
Cucumber 0.1 4,840 139,392 484.0 13,939.2 0.0011 0.0307
Muskmelon 0.1 2,420 34,848 242.0 3,484.8 5.34E‐04 0.0077
Pumpkin 0.1 908 7,260 90.8 726.0 2.00E‐04 0.0016
Squash, summer 0.1 1,452 15,374 145.2 1,537.4 3.20E‐04 0.0034
Squash, winter 0.1 2,723 7,260 272.3 726.0 6.00E‐04 0.0016
Watermelon 0.1 605 4,356 60.5 435.6 1.33E‐04 0.0010
Spinach 0.006 196,020 653,400 1,176.1 3,920.4 0.0026 0.0086
Carrot 0.002 104,544 2,090,880 209.1 4,181.8 4.61E‐04 0.0092
Parsley 0.002 52,272 1,568,160 104.5 3,136.3 2.30E‐04 0.0069
Turnip 0.002 29,040 261,360 58.1 522.7 1.28E‐04 0.0012
Beans/Peas 0.03 50,000 250,000 1,500.0 7,500.0 3.31E‐03 0.0165
1 Seed planting rates were provided by the Biological and Economic Analysis Division (USEPA 2011b)

75
APPENDIX G. Analysis to Characterize Chronic Risk to Seed‐Eating Birds and Mammals

Risk Characterization for Seed‐Eating Mammals

Guidance was finalized in 2016 that provides updated risk assessment methodology for better
characterizing risk to birds and mammals that may feed on treated seeds (USEPA 2016b). This
guidance provides two methods that characterizes exposure, taking into account the beneficial
effect of reduced exposure from burial or incorporation of seeds during planting. For better
characterization of chronic risk, the methodology provides equations for calculating two
theoretical parameters: 1) the foraged area of concern and 2) the foraged time of concern. The
foraged area of concern is defined as the amount of area the target species would have to
cover while foraging to consume enough pesticides from treated seeds to exceed the LOC. This
parameter is applicable to characterizing risk to birds and mammals. The foraged time of
concern is defined as the length of time that an individual animal would need to forage (at an
assumed maximum foraging rate) to consume enough pesticide from treated seeds to exceed
the LOC. Because of the lack of information on the foraging rate of granivorous mammals,
foraging time of concern method is currently applicable only for birds.

Using the available chronic toxicity NOAEL for mammals (10 mg a.i./kg‐bw per day), the
maximum seed treatment rates (Table 3‐1), and seed planting rates reported by BEAD (USEPA
2011), chronic area of concern (CAC) values were calculated for seed‐eating mammals (Table
G1). These values were calculated for small and medium sized mammals since these are the
ones most likely to feed extensively on crop seeds. In this analysis, large seeds of beans, peas,
cucurbits, and spinach, which need to be planted deeply, were assumed to be planted with a
drill seeder. The standard assumption used for seeds planted with a drill seeder (or similar
precision seeder) is that 1% of the seeds will be present on the soil surface. The smaller seeds
of other crops were assumed to be broadcasted onto the soil surface, followed by light
incorporation into the soil. Planting with this method is assumed to leave 15% of the seeds
present on the soil surface.

Table G1. Area of Concern Values for Mammals Eating Seeds Treated with Thiabendazole
Area of Concern in ft2
Seed Rate
Chronic Assumed % Seeding Rate (% of Home Range)
Use Site (mg
RQ on Surface1 (seeds/acre)2 Medium
a.i./seed) Small (15 g)
(35 g)
Alfalfa 5.00 0.004 15% 3,405,000 21 (0.1%) 40 (0.1%)
Barley 1,222,000‐
2.31 0.03 15% 7‐8 (<0.1%) 14‐15 (<0.1%)
1,300,000
Oats 3.00 0.03 15% 1,305,000 7 (<0.1%) 14 (<0.1%)
Rye 2.98 0.03 15% 1,962,000 5 (<0.1%) 9 (<0.1%)0.5
Triticale 3.75 0.03 15% 1,744,000 6 (<0.1%) 10 (<0.1%)0.4
Wheat 600,000‐ 7‐1150 (<0.1%‐ 13‐2180 (<0.1%‐
2.98 0.03 15%
1,350,000 7%) 5%)
Broccoli 681‐17,308 1290‐32700
1.65 0.002 15% 8,297‐210,845
(4%‐107%) (3%‐80%)
Cabbage 1.82 0.002 15% 7,260‐98,010 1470‐19800 2770‐37300

76
Area of Concern in ft2
Seed Rate
Chronic Assumed % Seeding Rate (% of Home Range)
Use Site (mg
RQ on Surface1 (seeds/acre)2 Medium
a.i./seed) Small (15 g)
(35 g)
(9%‐123%) (7%‐91%)
Onion 87,120‐ 115‐1650 216‐3110
1.43 0.002 15%
1,254,528 (0.7%‐10%) (0.5%‐8%)
Cucumber 309‐8900 584‐16800
10.0 0.1 1% 4,840‐139,392
(2%‐55%) (1%‐41%)
Muskmelon 1240‐17800 2330‐33600
11.5 0.1 1% 2,420‐34,848
(8%‐110%) (6%‐82%)
Pumpkin 5930‐47400 11200‐89600
3.53 0.1 1% 908‐7,260
(37%‐294%) (27%‐219%)
Squash, summer 2800‐29700 5290‐56000
3.53 0.1 1% 1,452‐15,374
(17%‐184%) (13%‐137%)
Squash, winter 2800‐15800 5290‐29900
3.53 0.1 1% 2,723‐7,260
(18%‐98%) (13%‐73%)
Watermelon 9890‐71200 18700‐134000
5.29 0.1 1% 605‐4,356
(61%‐329%) (46%‐329%)
196,020‐ 1100‐3660 2070‐6920
Spinach 1.50 0.006 1%
653,400 (6.8‐23%) (5.1‐17%)
Carrot 104,544‐ 69‐1370 130‐2590
4.41 0.002 15%
2,090,880 (0.4%‐8.5%) (0.3%‐6.3%)
Parsley 52,272‐ 92‐2750 173‐5187
3.27 0.002 15%
1,568,160 (0.6%‐17%) (0.4%‐13%)
Turnip 29,040‐ 550‐4950 1040‐9340
1.84 0.002 15%
261,360 (3%‐31%) (3%‐23%)
Crop Groups 6
50,000‐ 575‐2870 1080‐5420
and 7 2.43 0.030 1%
250,000 (4%‐18%) (3%‐13%)
(Beans and Peas)
1
Seeds that require a planting depth of greater than ½ inch (Sanchez, 2011)are assumed to be drill planted,
whereas seeds that are planted more shallowly are assumed to be broadcasted and then lightly incorporated into
the soil.
2
Seed planting rates were provided by Biological and Economic Analysis Division (BEAD, USEPA, 2011).

These results show that the seed treatment rate, seed planting rate, and planting method have
a large influence on the risk posed to mammals. For some crops, only a relatively small area
need to be foraged by a seed‐eating mammal for it to reach the chronic NOAEL dose. Crops for
which the CAC is small, comprising less than 10% of the mammal’s home range, are the
following:

 Alfalfa
 Wheat, oats, and other small grains
 Onion
 Carrot

If alfalfa, wheat, oats, and other small grains are drill‐seeded, which is more typical, the CAC
would be larger because fewer seeds would remain on the surface. However, the areas would

77
still be no greater than 2% of the home range, and therefore would corroborate the conclusion
of potential sublethal effects to small mammals consuming treated seeds. When onions and
carrots are started in greenhouses and then transplanted to the field, chronic risk would be low.

The CACs are somewhat larger, but still well below the home range size (no more than 23%), for
the following crops and crop groups:

 Beans and peas (crop group 6 and 7)


 Some root crops (e.g., turnip and parsley)
 Spinach

The CACs are largest for watermelon and pumpkin. This is the result of the plants being spaced
widely, making the seed planting rates relatively small. Using the minimum planting rates, the
model predicts CACs that are over three times the size of the home range. Using the maximum
seeding rates, the CACs are 37‐61% of the home range for small mammals and 27‐46% of the
home range for medium‐sized mammals. This method makes conservative assumptions,
including that the mammal is eating solely treated seeds and no other animals are removing
seeds from the surface of the field. Considering these conservative assumptions, even the
minimum percentages suggests that consumption of a chronically toxic dose is unlikely.
Therefore, this analysis indicates chronic risk is low for mammals eating watermelon seeds.

Results are uncertain for all other crops included in this analysis. For some they are uncertain
because the CAC and percentage of the home range fall in a moderate range, while for others it
is because the percentages range from very low to very high values, due to extreme variation in
seed planting rates. Crops for which the results are uncertain include the following:

 Broccoli
 Cabbage
 Cucurbit vegetables other than pumpkin and watermelon (e.g., cucumber, squash, and
muskmelons)

Again, when crops are started in greenhouse and later transplanted to the field as seedling,
negligible exposure is expected in these cases because wild mammals would not have access to
the seeds. According to information provided by BEAD (USEPA 2011b), crops that are
sometimes planted as transplants include many of the brassica vegetables (broccoli, Brussels
sprouts, cabbage, and cauliflower), muskmelon, onion, parsley, squash, sweet potato, and
watermelon.

Risk Characterization for Seed‐Eating Birds

For birds, characterization of risk is limited by the lack of a definitive NOAEC for chronic effects.
In the avian reproduction tests conducted with the bobwhite and with the mallard, no adverse
effects were observed at test concentrations up to 400 mg a.i./kg diet. We therefore do not

78
know the chronic NOAEC; we only know that the LOAEC is greater than 400 mg a.i./kg diet and
the NOAEC cannot be lower than 400 mg a.i./kg diet. To characterize this risk as well as
possible, we used the 400 mg a.i./kg diet level in the risk characterization calculations.
However, this approach only characterizes the potential lower bound of CAC (i.e., the lower
bound of risk). While high CAC values may indicate that risk is low, low values do not necessarily
indicate that risk is high.

For birds, we calculated the area that a bird would need to forage to reach a dose equivalent to
the 400 mg a.i./kg diet test level (lower‐bound CACs), and we converted these areas to lower‐
bound percentages of the predicted home range. These results are shown in Table G2.

Table G2. Lower‐Bound Area of Concern Values for Birds Eating Seeds Treated with
Thiabendazole
Area of Concern in ft2
Seed Rate
Chronic Assumed % Seeding Rate (% of Home Range)
Use Site (mg
RQ on Surface1 (seeds/acre) Medium
a.i./seed) Small (20 g)
(100 g)
Alfalfa 5.00 0.004 15% 3,405,000 20 (<0.1%) 101 (<0.1%)
Barley 1,222,000‐ 35‐37
2.31 0.03 15% 7 (<0.1%)
1,300,000 (<0.1%)
Oats 3.00 0.03 15% 1,305,000 7 (<0.1%) 35 (<0.1%)
Rye 2.98 0.03 15% 1,962,000 5 (<0.1%) 23 (<0.1%)
Triticale 3.75 0.03 15% 1,744,000 5 (<0.1%) 26 (<0.1%)
Wheat 600,000‐
2.98 0.03 15% 0.1%‐0.2% 0.05%‐0.1%
1,350,000
Broccoli 650‐16,500 3250‐82600
1.65 0.002 15% 8,297‐210,845
(0.4%‐11%) (0.4%‐8.8%)
Cabbage 1400‐18,900 6990‐94,400
1.82 0.002 15% 7,260‐98,010
(0.9%‐13%) (0.8%‐10%)
Onion 87,120‐ 109‐1570 546‐7870
1.43 0.002 15%
1,254,528 (0.1%‐1.0%) (0.1%‐0.8%)
Cucumber 295‐8,500 1,480‐42,500
10.0 0.1 1% 4,840‐139,392
(0.2%‐5.6%) (0.2%‐4.5%)
Muskmelon 1180‐17,000 5900‐85,000
11.5 0.1 1% 2,420‐34,848
(0.8%‐11%) 1.0%‐9.1%
Pumpkin 28,300‐226,000
3.53 0.1 1% 908‐7,260 NA1
(3.0%‐24%)
Squash, summer 13,400‐142,000
3.53 0.1 1% 1,452‐15,374 NA1
(1.4%‐15%)
Squash, winter 28,300‐75,500
3.53 0.1 1% 2,723‐7,260 NA1
(3.0%‐8.1%)
Watermelon 9440‐68,000 47,200‐340,000
5.29 0.1 1% 605‐4,356
(6.3%‐45%) (5.0%‐36%)
196,020‐ 1050‐3500 5250‐17,500
Spinach 1.50 0.006 1%
653,400 (0.7%‐2.3%) (0.6%‐1.9%)
Carrot 104,544‐ 66‐1311 328‐6556
4.41 0.002 15%
2,090,880 (<0.1%‐0.9%) (<0.1%‐0.7%)

79
Area of Concern in ft2
Seed Rate
Chronic Assumed % Seeding Rate (% of Home Range)
Use Site (mg
RQ on Surface1 (seeds/acre) Medium
a.i./seed) Small (20 g)
(100 g)
Parsley 52,272‐ 87‐2620 437‐13,100
3.27 0.002 15%
1,568,160 (0.1%‐1.7%) (0.1%‐1.4%)
Turnip 29,040‐ 525‐4720 2620‐23,600
1.84 0.002 15%
261,360 (0.4%‐3.1%) (0.3%‐2.5%)
50,000‐ 2740‐13,700
Peas 2.43 0.030 1% NA1
250,000 (0.3%‐1.5%)
1
Seeds that require a planting depth of greater than ½ inch (Sanchez, 2011) are assumed to be drill planted,
whereas seeds that are planted more shallowly are assumed to be broadcasted and then lightly incorporated into
the soil.

The results show that, for all crops, the CAC is no more than 45% of the bird’s home range, with
several estimates showing well less than 10% of the CAC. Therefore, the foraging area of
concern analysis does not support a conclusion of low chronic risk to seed eating birds for any
use site. However, as stated above, the low CAC values do not necessarily indicate high risk
because further avian reproduction testing at higher levels could find that the NOAEC is
considerably greater than 400 mg a.i./kg diet, which would mean these calculations
underestimate risk. The analysis does indicate that chronic avian risk is greater for some use
sites than for others. Cucurbit vegetable crops, especially pumpkin and watermelon, have the
largest CAC values, indicating the lowest risk among the use sites. This is mainly because the
seeds are planted widely apart, and therefore more area needs to be foraged for the bird to get
a toxic dose. At the upper range, the CAC for pumpkin and watermelon comprises 24% to 45%
of the bird’s home range. The brassica vegetable crops, broccoli and cabbage, had CAC values in
the middle of the range (up to 9‐13% of the home range), indicating moderate risk compared to
the other use sites. Small grains, legumes, root crops, alfalfa, and spinach had the lowest CAC
values (<4% of the home range), indicating that very little treated seed would need to be
consumed to reach the toxicity threshold (if a definitive avian NOAEC is comparable to the
mammalian NOAEC).
The 2016 guidance memorandum (USEPA, 2016) provides a second method for characterizing
the risk to birds that involves calculation of a second value called the time of concern. This is
the estimated minimum amount of time that a bird would be required to consume enough
treated seeds to reach the NOAEL, or in this case, the dose equivalent to the 400 mg a.i./kg diet
exposure level. This time is then compared to the total time that a bird would have to forage
for seeds in a day, which is estimated at 8 hours. The analysis depends on the predicted
handling time for a bird to eat one seed, which in turn depends upon the estimated seed size.
The method also accounts for the maximum seed size that a bird of a given size can consume.
When the seed size is too large for the bird to eat, exposure to birds of that size is assumed to
be negligible. As with the CAC values, these chronic time of concern (CTC) values are lower‐
bound values. Lower‐bound CTC values for birds eating seeds of various crops are given in Table
G3.

80
Table G3. Lower‐Bound Time of Concern Values for Birds Eating Seeds Treated with
Thiabendazole
Foraging Time of Concern in Minutes
Seed Rate
Chronic Seed Count per (% of Max Foraging Time)
Use Site (mg
RQ Pound Medium
a.i./seed) Small (20 g)
(100 g)
Alfalfa 15‐17 94
5.00 0.004 199,000 to 227,000
(3.2%‐3.6%) (20%)
Barley 5.7‐1060 17‐21
2.31 0.03 8,400 to 14,000
(1.2%‐221%) (3.5%‐4.4%)
Oats 4.5‐107 15‐17
3.00 0.03 13,000 to 18,144
(1.0%‐22%) (3.3%‐3.6%)
Rye 4.6‐33 16
2.98 0.03 18,000
(1.0%‐7.0%) (3.3%)
Triticale 4.0‐61 15‐17
3.75 0.03 15,000 to 22,680
(0.8%‐13%) (3.1%‐3.5%)
Wheat 4.5‐225 15.7‐18.4
2.98 0.03 8,000 to 18,000
(0.9%‐47%) (3.3%‐3.8%)
Broccoli 35‐48 189‐194
1.65 0.002 80,000 to 150,000
(7.3%‐10%) (39%‐40%)
Cabbage 33.9‐81.6 189‐202
1.82 0.002 45,000 to 165,000
(7.1%‐17%) (39%‐42%)
Onion 34‐82 189‐203
1.43 0.002 100,000 to 190,000
(7.1%‐17%) (39%‐42%)
Cucumber 1.3‐45 4.7‐5.4
10.0 0.1 12,000 to 18,144
(0.3%‐9.0%) (1.0%‐1.1%)
Muskmelon 1.2‐15 4.6‐4.9
11.5 0.1 16,000 to 20,800
(0.3%‐3.1%) (0.9%‐1.0%)
Pumpkin 7.5‐63
3.53 0.1 1,600 to 6,400 NA1
(1.6%‐13%)
Squash, summer 7.5‐39
3.53 0.1 1,920 to 6,400 NA1
(1.6%‐8.1%)
Squash, winter 7.5‐39
3.53 0.1 1,920 to 6,400 NA1
(1.6%‐8.1%)
Watermelon 2.7‐41,000 5.89‐9.44
5.29 0.1 4,800 to 9,600
(0.6%‐8530%) (1.2%‐2.0%)
14‐32 3.0‐6.6
Spinach 1.50 0.006 40,000 to 45,360
(3.0%‐6.6%) (14%)
Carrot 28‐35 186‐188
4.41 0.002 175,000 to 400,000
(5.8%‐7.3%) (39%)
Parsley 29‐35 186‐189
3.27 0.002 150,000 to 296,500
(6.1%‐7.4%) (39%)
Turnip 34‐35 189
1.84 0.002 167,000
(7.0%‐7.3%) (39%)
30‐343
Peas 2.43 0.030 1361 to 5,000 NA1
(6.3%‐71%)
1
NA indicates consumption of this seed is not applicable to birds of this size because the seeds are too large for
the birds to consume.

This time of concern analysis indicates that the CTC generally is no more than 200 minutes (3
1/3 hours). The lower range of the CTC is often less than 30 minutes. Therefore, assuming a bird
81
can forage for up to 8 hours a day, these results do not dismiss the potential for sublethal
effects after consuming treated seed, for any use site. However, as with the CAC analysis, the
results do not necessarily indicate risk because the 400 mg a.i./kg diet estimate may
underestimate the true NOAEC. Furthermore, this analysis is conservative because it only
accounts for the time it takes to handle seeds while eating them, but does not readily account
for the time it can take for the bird to find each seed. When comparing use sites, brassica
vegetables (represented by broccoli and cabbage), root vegetables, and legumes have larger
CTC values, indicating lower risk. Spinach, cucumber, squash, melons, and small grains such as
wheat and oat have smaller CTC values, indicating greater potential for birds to reach a toxic
dose by eating seeds.

Comparison of seed size to the maximum size that can be eaten by a bird shows that pumpkin,
squash, and peas are too large for small birds to eat. Beans are also too large for small and
medium size birds. These use sites therefore would have low chronic risk to these types of
birds. In addition, some use sites often would pose low chronic avian risk because the seeds are
typically started indoors and then transplanted as seedlings. According to information provided
by BEAD (USEPA 2011b), crops that are sometimes planted as transplants include many of the
brassica vegetables (broccoli, Brussels sprouts, cabbage, and cauliflower), muskmelon, onion,
parsley, squash, sweet potato, and watermelon.

82
APPENDIX H. Antimicrobial Uses Quantitative Draft Risk Assessment for Thiabendazole

UNITED STATES ENVIRONMENTAL PROTECTION


AGENCY
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

MEMORANDUM February 20, 2019

SUBJECT: Registration Review Quantitative Draft Risk Assessment of Potential Risks to


Nontarget Organisms from Antimicrobial Applications of Thiabendazole

PC Code(s): 060101 DP Barcode(s)/No(s): NA


Regulatory Action: Draft Risk Assessment Case No(s): 2670
Risk Assess Type: Single Chemical CAS No(s): 148‐79‐8

From: Diana Hsieh, Biologist


Kathryn Korthauer, Biologist
Risk Assessment and Science Support Branch
Antimicrobials Division (7510P)

Thru: Laura Parsons, Associate Branch Chief


Risk Assessment and Science Support Branch
Antimicrobials Division (7510P)

To: SanYvette Williams, VMO/PHS


Richard Fehir, Team Lead
Regulatory Management Branch II
Antimicrobial Division (7510P)

Margaret Hathaway, Chemical Review Manager


Pesticide Re‐Evaluation Division (PRD) (7508P)

83
1.0 Executive Summary
The Agency has conducted a quantitative ecological draft risk assessment for the
antimicrobial uses of thiabendazole. The environmental risk conclusions are summarized below.
Based on the limited waste water treatment plant (WWTP) environmental fate data for
thiabendazole, the Agency assumes that 100% of thiabendazole that enters a WWTP may be
discharged from the WWTP.
Screening level down‐the‐drain exposures were modeled for the industrial release of
thiabendazole from pulp and paper mills at a maximum labeled application rate of ~1250 ppm
a.i and a low application rate of 50 ppm a.i. Both application rates were derived from the same
label (Reg no. 42750‐227). Although ~1250 ppm a.i. is the highest registered application rate of
thiabendazole within pulp and paper mills, 50 ppm a.i. was used solely to bracket risk and is a
low application rate but not necessarily the lowest registered application rate.
The results indicated that freshwater fish and invertebrate acute concentrations of concern
(COCs) are exceeded 38‐291 days per year at the maximum labeled application rate and are
reduced to 0‐10 days per year at the low concentration. Similarly, chronic COCs are exceeded
73‐353 days per year with the maximum application rate but are reduced to 2‐74 days per year
with the low rate. COCs for aquatic plants are exceeded 3‐51 days at the maximum labeled
application rate, but not exceeded at the low application rate. Potential risks to the aquatic
receptor groups cannot be ruled out for any day in which COCs are exceeded.

2.0 Current Antimicrobial Registrations and Uses


Thiabendazole is registered for use as a material preservative and antifungal agent to
inhibit the growth of mold and mildew associated with odors, staining, discoloration, and
general biodeterioration on adhesive films, wallpaper adhesives, interior and exterior latex or
solvent/oil based paint films, stains, paper products, heating and cooling system filters and/or
room air cleaners/purifiers, wallboard, sealants, grout, ceiling tiles, plastics, plastic
intermediates, flexible PVC systems, polymeric products, cellulosic sponges, rubber, canvas
textiles, and carpet backing, and natural and synthetic fibers.
As of 2/7/19, thiabendazole was registered in 19 antimicrobial products with the following
registration numbers: 39967‐30, 39967‐33, 39967‐35, 39967‐42, 39967‐43, 39967‐47, 39967‐
65, 39967‐86, 39967‐87, 39967‐131, 39967‐132, 39967‐133, 39967‐134, 39967‐143, 39967‐147,
39967‐155, 42750‐227, 92760‐9, and 92760‐10.
In‐service use of consumer products containing thiabendazole as a material preservative
(i.e. paints, textiles, plastics, etc) may leach throughout their lifecycles. However, these
environmental exposures are expected to be minimal when compared to the use of

84
thiabendazole in pulp and paper production, which results in direct discharge of thiabendazole
into water bodies downstream from WWTPs. Therefore, the Agency has determined that paper
production has the greatest potential for environmental exposures and has chosen to evaluate
this use within this risk assessment. The Agency has chosen registration number 42750‐227 to
use as the representative label in this risk assessment as its uses result in the highest exposure
of thiabendazole at the highest concentration (~1250 ppm a.i). The minimum labeled
application rate associated with this product is 50 ppm a.i and although it may not represent
the lowest registered application rate, it was utilized to bracket risk.

3.0 Ecological Risk Assessment


3.1 Risk Estimation Methodology
Risk estimation integrates the results of the exposure and ecotoxicity data to evaluate the
potential for an active ingredient and its transformation products to cause adverse effects to
nontarget organisms. Depending on the uses being assessed, risk estimates are determined
from calculations of acute and chronic risk quotients (RQs) or, in the case of down the drain
assessments, from concentrations of concern (COCs). For this assessment, the Agency used the
Industrial Release module within the Exposure and Fate Assessment Screening Tool (E‐FAST)4
model to predict surface water exposure to thiabendazole used in paper and paperboard mills.
3.2 Industrial Release Methodology
Risks to aquatic organisms from antimicrobial chemicals with the potential to get into
flowing surface water via municipal or industrial WWTPs are analyzed using the E‐FAST. For
discharges from industrial sources (e.g., paper mills), the General Population and Ecological
Exposure from Industrial Releases Module (herein called the Industrial Release module) is used.
For antimicrobials disposed via point sources (i.e., WWTP or direct industrial discharge),
the Probabilistic Dilution Model (PDM) option is used. This option estimates the number of days
per year that the Concentrations of Concern (COC) are exceeded for nonlisted freshwater fish,
freshwater non‐benthic invertebrates, and aquatic plants. Key input data include: (1) percent
removal of active ingredient during wastewater treatment; (2) acute and chronic ecotoxicity
endpoints for each receptor group; (3) retention rate of the chemical on the paper; (4) an
estimate of environmental release to surface water in kilograms per site per day; and (5)
release site information.

4
Additional information on E‐FAST is available here: https://www.epa.gov/sites/production/files/2015‐
04/documents/efast2man.pdf

85
The Agency has conducted a high end (low flow) and an average (average flow) analysis to
determine the conditions under which exposure and potential adverse risks to freshwater
aquatic organisms may occur. The high‐end scenario is based on the upper 10th percentile of the
distribution of the ratio of 7Q10 stream flows to WWTP flows. The average case scenario is
based on the median of the distribution of the ratio of 7Q10 stream flows to WWTP flows. The
7Q10 is the lowest 7 consecutive day stream flow over a 10‐year period. For the high‐end
scenario, the ratio of stream flow to plant flow is relatively low since plant flows can contribute
considerable volume to the flow of the stream and the resulting surface water concentrations
can be relatively high. For the average case scenario, the ratio of stream flow to plant flow is
more representative of typical conditions. For more information regarding EFAST and how to
run the model see Appendix I.
It should be noted that that because EFAST is based on stream flow distribution, it is not
appropriate for estimating risk to estuarine/marine or benthic organisms. Since pulp and paper
plants do not discharge directly into estuarine/marine environments and no thiabendazole
endpoints are available for benthic organisms, no additional risk assessments were done at this
time for those organisms.
3.2.1 Key Inputs
(1) Percent removal of active ingredient during wastewater treatment

The Agency possesses three wastewater treatment (WWT) studies for thiabendazole. A
ready biodegradability study (MRID 49747401) was conducted but classified as unacceptable
due to critical flaws within the study. A simulation test (MRID 50400501) was submitted and
demonstrated negligible degradation of thiabendazole during WWT (6% total after 28 days). An
activated sorption respiration inhibition study (MRID 49747402) determined thiabendazole was
not toxic to waste water treatment organisms with an IC50 of >1000 mg/L.
The Agency does not possess an activated sorption isotherm study; however, an
estimated minimal sorption rate during wastewater treatment of 2.9% was derived based on
EPI Suite modeling. Since EPI Suite is an estimation program, the Agency has taken the
conservative estimate that 0% of thiabendazole will sorb. However, sorption of 2.9% would not
significantly change the risk estimates for thiabendazole.
Based on the lack of biodegradation and estimated lack of sorption, any release of
thiabendazole into WWTPs are assumed to result in 100% exposure of thiabendazole in aquatic
areas. Thiabendazole is not expected to inhibit microbial activity during WWT.
(2) Ecotoxicity Endpoints and Concentration of Concern (COC) Calculations
The results of the Industrial Release module are expressed as the number of days per
year that COC’s are exceeded for aquatic freshwater organisms. The Agency used the most

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sensitive ecotoxicology endpoints for surrogate species to assess risk to each aquatic receptor
group, such as freshwater fish, freshwater non‐benthic invertebrate, and aquatic plants. COCs
were determined in the following way and are expressed in µg/L (see Table 1 for specific COCs
entered into EFAST):
 Acute COCs for aquatic vertebrates and invertebrates (Non‐listed): LC50 or EC50
values from acute toxicity tests divided by 2.
 Chronic COCs for aquatic vertebrates and invertebrates (Nonlisted): NOAEC
values from chronic toxicity tests.
 COCs for Aquatic vascular plants and algae (Non‐listed): EC50 values from toxicity
tests.

Table 14‐1: Summary of COCs Calculated for Thiabendazole.

Toxicity Value (in Concentration


Taxonomic Source (Study
Surrogate Species Study Type terms of active of Concern
Group Classification)
ingredient) (COC)
41025005
Rainbow Trout Acute 96‐hr LC50 = 0.56 mg/L 280 µg/L
Freshwater (Acceptable)
(Oncorhynchus
fish Chronic (Early 33‐day NOAEC = 0.11 42508901
mykiss) 110 µg/L
Life‐ Stage) mg/L (Acceptable)
00123326
Acute 48‐hr EC50 = 0.31 mg/L 155 µg/L
Freshwater Water Flea (Acceptable)
invertebrates (Daphnia magna) 00094645
Chronic NOAEC = 0.042 mg/L 42 µg/L
(Acceptable)
Duckweed 48996308
Vascular 7‐day EC50 = 2.32 mg/L 2320 µg/L
(Lemna gibba) (Supplemental)
Aquatic
plants and Cyanobacteria,
algae 96‐hr EC50 = 1.42 49928202
(Anabaena flos‐ Non‐ vascular 1420 µg/L
mg/L (Acceptable)
aquae)

(3) Retention Rate of the Chemical on the Paper


Depending on where within the paper/paperboard making process a chemical is used,
the average retention rate on the paper or within the paper sludge can vary. Based on the
labeled directions (registration number 42750‐227), it was determined that the retention rate
of chemicals applied in wet‐end operations was the most appropriate. According to the 2009
OECD Paper Scenario’s Emissions Table (Table 4.3, OECD 2009), the quantity of chemical from
these sources going to an effluent treatment plant is approximately 10% (90% retention on
paper and paper sludge).

87
(4) Environmental Release to Surface Water (kg a.i./site/day)
To determine the maximum amount of thiabendazole (kg/site/day) that could be used in
a paper and paperboard mill, it is necessary to know the maximum amount of paper that can be
produced. The Antimicrobial Division uses the general assumption that 500 US tons of paper is
produced per site per day in pulp and paper mills. This is a conservative assumption and
represents production in a moderate sized paper mill. The total a.i used per day (kg/site/day)
was calculated using the following equation:

Total a.i. used per site per day (kg/site/day):

. . 1,000 1 1 . .
1 1 1.10231 1 10 . .

= X kg a.i./site/day

Total a.i. used at the maximum labeled rate per site per day (1250 ppm):

1250 . . 1,000 1 500 1 . .


1 1 1.10231 1 10 . .

= 570 kg a.i./site/day

Total a.i. used at the minimum labeled rate per site per day (50 ppm):

50 . . 1,000 1 500 1 . .
1 1 1.10231 1 10 . .

= 22.68 kg a.i./site/day

In order to estimate the total environmental release to surface water, the amount of a.i.
retained within/on the paper and the amount of a.i. removed during WWT must be taken into
account in the following way:

AI Released to Surface Water:


1 % 1 %

For the maximum labeled rate (1250 ppm):

AI Released to Surface Water = 570 kg/site/day x (1‐0.90) x (1 ‐ 0.00) = 57.0 kg a.i./site/day

At the minimum labeled rate (50 ppm):


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AI Released to Surface Water = 22.68 kg/site/day x (1‐0.90) x (1 ‐ 0.00) = 2.27 kg a.i./site/day

(5) Release Sites Information


In order to run EFAST, various inputs about the release sites must be determined and
are as follows:
 Days per year of release; the default assumption is 360 days.
 Standard Industrial Classification (SIC) code analysis or facility analysis; the SIC code
“Paper and Paperboard Mills” was chosen because no specific facility was being
analyzed.
 The number of use sites. Due to lack of market specific data, the Agency set the
number of use sites to one.

3.3 E‐FAST Results


The results of the module runs are expressed as number of days of exceedance of
concentrations of concern (COC) for aquatic organisms and may be found in table 2.
Table 14‐2: Days Per Year of Exceedance of COCs for Thiabendazole to Aquatic Organisms
Low Rate1 Highest Labeled Rate1
(50 ppm a.i.) (1250 ppm a.i.)
High‐End2 Average3 High‐End2 Average3
Acute
Freshwater fish
3 0 228 38
(280 µg/L)
Freshwater
invertebrates 10 1 291 58
(155 µg/L)
Chronic
Freshwater fish
18 2 316 73
(110 µg/L)
Freshwater
invertebrates 74 9 353 120
(42 µg/L)
Aquatic Plants
Duckweed
0 0 24 3
(2320 µg/L)
Cyanobacteria
0 0 51 6
(1420 µg/L)
1‐ The highest labeled application rate is from EPA registration number 42750‐227. The low application rate is the
minimum concentration on this same label.

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2‐ High‐end (i.e. low‐flow) is based on the upper 10th percentile of the distribution of the ratio of 7Q10 stream flow
to WWTP flow.
3‐ Average is based on median of the distribution of the ratio of 7Q10 stream flow to WWTP flows.

3.4 Ecological Risk Conclusions


3.4.1 Freshwater Fish and Invertebrates
The screening level evaluation of thiabendazole used in pulp and paper mills indicated
that freshwater fish and invertebrate acute concentrations of concern (COCs) are exceeded 38‐
291 days per year at the maximum labeled application rate (1250 ppm a.i., EPA Reg No. 42750‐
227), and are reduced to 0‐10 days per year at the low concentration (50 ppm a.i.). Similarly,
chronic COCs are exceeded 73‐353 days per year with the maximum application rate but are
reduced to 2‐74 days per year with the low rate. Potential risks to the receptor groups cannot
be ruled out for any day in which COCs are exceeded.
3.4.2 Aquatic Plants
COCs for aquatic plants are exceeded for 3‐51 days at the maximum labeled application
rate (1250 ppm a.i.), but not exceeded at the low application rate (50 ppm a.i.). Potential risks
to the receptor groups cannot be ruled out for any day in which COCs are exceeded.

3.5 Model Uncertainties


For this assessment the Agency has used conservative estimates. This risk assessment
could be further refined with production volume data, additional WWTP studies, additional
information on where/when thiabendazole is added during the paper making process, and
information on how many sites use thiabendazole. Additional data would have likely resulted in
reduced risks, compared to what is currently presented in this assessment.

4.0 References
MRID 00094645. LeBlanc, G.A.; Mastone, J.D.; Suprenant, D.C.; et al. (1981) The Chronic Toxicity
of Mertect Fungicide to the Water Flea (Daphnia magna): Report #BW‐81‐6‐900.
(Unpublished study received Jan 19, 1982 under 618‐75; prepared by EG & G Bionomics,
submitted by Merck & Co., Inc., Rahway, N.J.; CDL: 246711‐B)
MRID 00123326. Vilkas, A. (1977) The Acute Toxicity of Thiabendazole Technical to the Water
Flea (Daphnia magna Straus): UCES Proj. # 11506‐ 42‐ 02. (Unpublished study received
Jul 5, 1978 under 618‐75; prepared by Union Carbide Corp., submitted by Merck & Co.,
Inc., Rahway, NJ; CDL:235634‐D)

90
MRID 41025005. Beglinger, J.; O'Boyle, R. (1989) Acute Aquatic Effects of Thiabendazole on the
Rainbow Trout, Salmo gairdneri: Study No. EN‐412‐GWN001‐2. Unpublished study
prepared by Eastman Kodak Co. 58 p.
MRID 42508901. Holmes, C.; Swigert, J. (1992) Thiabendazole: An Early Life‐Stage Toxicity Test
with the Fathead Minnow (Pimephales promelas): Lab Project Number: 105A‐111.
Unpublished study prepared by Wildlife International Ltd. 58 p.
MRID 48996308. Soucy, K. (2012) Thiabendazole ‐ 7‐Day Toxicity Test with Duckweed (Lemna
gibba): Final Report. Project Number: TK0052142/OCR, 1781/6811. Unpublished study
prepared by Smithers Viscient Laboratories. 68p.
MRID 49146601. Batscher, R. (2004) Thiabendazole (MK360) ‐ A 96‐Hour Algal Growth
Inhibition Test with Pseudokirchneriella subcapitata (Formerly Selenastrum
capricornutum): Final Report. Project Number: 853033, 2033694, TK0185578.
Unpublished study prepared by RCC, Ltd. 46p.
MRID 49747401. Kolk, J. (1998) MMK 360 B (Thiabendazole): Ready Biodegradability CO2
Evolution Test (Modified Sturm Test): Final Report. Project Number: 98/229/1047,
1047/025/775, TK/0283698. Study prepared by Springborn Laboratories (Europe) AG.
43p.
MRID 49747402. Kolk, J. (1998) MK 360 B (Thiabendazole): Activated Sludge, Respiration
Inhibition Test: Final Report. Project Number: 98/227/1047, 1047/025/790, TK0283700.
Study prepared by Springborn Laboratories (Europe) AG. 45p.
MRID 50400501. Wang, N.; Schaefer, E. (2017) Thiabendazole: Biodegradation in Activated
Sludge: Final Report. Project Number: 796E/103. Unpublished study prepared by EAG
Laboratories. 84p.
U.S. EPA. 2007. Exposure and Fate Assessment Screening Tool (E‐FAST), Version 2.0,
Documentation Manual. https://www.epa.gov/sites/production/files/2015‐
04/documents/efast2man.pdf

91
APPENDIX I. How to Use EFAST

Running EFAST
E‐FAST, version 2.0, was used to determine the magnitude and frequency of exposure of aquatic
organisms to thiabendazole from its use in paper and paperboard mills. For detailed information
on the features, data, and methods on which the models in E‐ FAST, version 2.0, are based,
refer to the latest version of the Documentation Manual for E‐ FAST, version 2.0 (US EPA, 2007).
This discussion is limited to summarizing the steps required to estimate exposure of aquatic
organisms to effluent water from the industrial use of thiabendazole in paper and paperboard
mills using the General Population and Ecological Exposure from Industrial Releases module of
E‐FAST with the PDM (probabilistic dilution model) option. The user is guided through a series of
menus or pages that provide prompts indicating where the user should input data.
One of the first screens that appears when running the General Population and Ecological
Exposure from Industrial Releases module of E‐FAST is the physical/chemical and fate inputs
screen. Upon accessing this screen, the user must enter the following information:

 Chemical identification (e.g., CAS number);


 Chemical name or abbreviation;
 Bioconcentration factor (measured or estimated) (used to estimate human exposure
from ingestion of fish);
 Percent wastewater treatment removal (measured or estimated);
 Percent adsorption to wastewater treatment sludge (measured or estimated); and
 Percent drinking water treatment removal (in the absence of data, assume no
removal).
The user must also select the appropriate models for estimating exposure to aquatic organisms
(for this assessment the General Population and Ecological exposure from Industrial Releases to
Surface Water model with the option to also run the probabilistic dilution model was used).
Next, the user accesses the “Release Information Page”. This page consists of three sub‐pages
including:

 General release information;


 Select a facility; and
 Select an SIC code.
The “select a facility” subpage, which accesses a database of site‐specific information for
manufacturing facilities, is not applicable for estimating exposures from processing and

92
industrial use. To estimate exposures to aquatic organisms from surface water releases from
processing or industrial use, the user must provide input values for the “general release
information” subpage and the “select an SIC code” subpage. On the general releases
information subpage, the user must input the following:

 Type (media) of release (i.e., surface water, landfill, and/or ambient air); for this
assessment, “surface water” was used.
 Amount of chemical released in kg a.i./site/day
 Days per year of release or days per year of plant operation; for this assessment 360
days was used
 Upon being presented with a choice of selecting “SIC code analysis” or “facility
analysis”, select SIC code analysis. A menu of SIC code descriptions will appear on the
screen and the user will be prompted to select one; in this instance, the appropriate
SIC code description would be “Paper and Paperboard Mills” which includes SIC Codes
2621, 2631, and 2661.
 Input the number of paper and paperboard mills; for this assessment “1” mill was used.
 In the box, “enter release activity”, the user has the option to enter a description of
the release.
 Place a check in the box, “include PDM run”.
 Enter three values for concentrations of concern COC
 Select results for high‐end or average exposure (explained below).

Next, the user should click the box, “Release activities completed? Continue to Exposure Factors
page.” Upon clicking this box, the Exposure Factors page will appear. The information in the
exposure factors page is not used to estimate exposures to aquatic organisms but is used to
quantify human exposures from ingestion of drinking water and fish. This page includes default
values for body weight, exposure duration, averaging time, and acute and chronic drinking
water and fish ingestion rates. These values are automatically selected unless the user changes
them.
Finally, click “calculate, save results, and display results pages”. This will bring the user to the
results page. The “PDM SIC Code” tab will bring the user to the display where the “# Days
Exceeded” are presented for each COC.

Description of High‐‐End Versus Average Case Scenario

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The General Population and Ecological Exposure from Industrial Releases module of E‐FAST
uses environmental releases, stream dilution factors (i.e., the ratio of stream flow to industrial
wastewater treatment plant flows), and wastewater treatment removal efficiency to provide
both high‐end and median time‐averaged surface water concentrations of a chemical substance
immediately downstream of a discharge point. Stream flows are not single point estimates
since streams have a highly variable seasonal flow pattern. PDM uses probability distributions
as inputs and calculates the resulting probability distribution of the stream concentration.
Once a representative SIC code is selected, the model will develop a distribution of stream
dilution factors based on the ratio of stream flows to plant flows for facilities that belong to a
specified SIC code. The distribution of stream flow values used are those immediately
downstream of the facilities that belong to a specified SIC code. For this risk assessment, stream
dilution factors (SDFs) for paper and paperboard mills were based on the ratio of receiving
stream flows to facility effluent flows for those facilities included in the paper and paperboard
mills SIC code (SIC 2621, 2631, and 2661).
For the high‐end scenario which uses the 10th percentile of the ratio of the distribution of 7Q10
stream flows to the WWTP flows, results of the number of days per year that COCs are
exceeded are based on the upper 10th percentile of SDFs. For the average case scenario, which
uses the 50th percentile of the ratio of the distribution of 7Q10 stream flows to the WWTP
flows, results of the number of days per year that COCs are exceeded are based on the 50th
percentile of SDFs. For the upper 10th percentile SDFs, or high‐end scenario, the stream flow to
plant flow ratio is relatively low since plant flows can contribute considerable volume to the
flow of the stream and resulting surface water concentrations can be relatively high. For the
50th percentile SDF, the stream flow to plant flow ratio is more typical.

References
U.S. EPA. 2007. Exposure and Fate Assessment Screening Tool (E‐FAST), Version 2.0,
Documentation Manual. https://www.epa.gov/sites/production/files/2015‐
04/documents/efast2man.pdf

94

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