SEPA
United States Prevention, Pesticides EPA 738-R-02-003
Environmental Protection and Toxic Substances August 2002
Agency (7508C)
Reregistration
Eligibility Decision for
Thiabendazole and Salts
738R02003
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-02-002
May 2002
SEPA R.E.D. FACTS
Pesticide
Reregistration
Thiabendazole and Salts
All pesticides sold or distributed in the United States must be registered by EPA,
based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment Because of advances in
scientific knowledge, the. law requires that pesticides which were first registered
before November 1, 1984, be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a complete
set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of Ihe Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants
and children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxiciry. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document This fact sheet
summarizes the information in the RED document for reregistration case 2760,
Thiabendazole and Salts.
Use Profile Thiabendazole is used to control a variety of fruit and vegetable diseases such as
mold, blight, rot and stains caused by various fungi. Thiabendazole is
formulated as a ready-to-use, dusts, fiowable concentrates, emulsifiable
concentrates, wettable powders, granules, and water dispersable granules. It's
registered for use as a pre-planting dust treatment to potato seed-pieces, sweet
potato seed pieces, soybean, and wheat It is also registered for use on
mushrooms and is mostly used post-harvest as a dip or spray on citrus fruits,
apples, pears, bananas, mangos, papaya, plantain, carrots, avocados, peas, and
potatoes. Thiabendazole salt uses include a ready-to-use formulation for
ornamental bulbs, elm and sycamore trees. Thiabendazoie salt is also used as a
preservative in paints, carpets, adhesives and textiles.
Thiabendazole can be applied by dipping, spraying, or application during the
waxing procedure for fruits and vegetables. Seed treatments are applied with a
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ready-mix or slurry-mix, A ready-to-use formulation is added to paints, carpets,
textiles and adhesives.
Regulatory Thiabendazole was first registered as a pesticide in the U.S. in 1969 by Merck
History ^ Company, Inc. Merck and Company, Inc. manufactured the technical
product and other companies manufactured end-use products. The primary
. registrant of end use products has been Syngenta Crop Protection, Inc. Merck
and Company, Inc. held the registration of the technical product until 1998.
Technical product was later transferred to Syngenta Crop Protection,Inc. and
retained it's name as Mertect Fungicide. Currently, 62 Thiabendazole pesticide
products are registered. A Data Call-In (DCI) was issued in 1991 for
thiabendazole requiring the submission of additional data on product chemistry,
toxicity, environmental fate and ecological effects, A subsequent DCI was issued
in 1995 requiring data to help estimate post-application exposure. The
Reregistration Eligibility Decision (RED) reflects a reassessment of all data
which were submitted in response to the DCI's,
Human Health
Assessment
Toxicity
Thiabendazole generally has been shown to have low acute dermal toxicity. It is
neither irritating to the eyes or skin nor is a dermal sensitizer. Toxicity
Categories, which range from 1 (most toxic) to 4 (least toxic), were mostly 4 for
thiabendazole. The thyroid and liver are the primary target organs of
thiabendazole. In a rat subchronic study, there were increases in liver and thyroid
weights. Also, in a chronic dog study, thiabendazole produced a similar effect in
increased liver weight
Thiabendazole generally is of low acute toxicity, however, the Agency has
classified thiabendazole as likely to be carcinogenic at doses high enough to cause
disturbance of the thyroid hormone balance. It is not likely to be carcinogenic at
doses lower than those which could cause a disturbance of this hormonal balance.
After consideration of expected exposure authorized under current EPA registered
use patterns as well as consideration of allowable dietary exposure from imported
crops treated with thiabendazole, the Agency has determined that individuals
would be exposed to levels which are far less than those sufficient to cause
cancer. The Agency is using the MOE approach for the human cancer risk
assessment Use of Pesticide Data Program (PDP) monitoring data, field trial
data, tolerance level residues and calculated livestock residues have resulted in a
MOE approach of 13,000 for the general U.S. population which is below the
Agency's level of concern. A MOE of 13,000 means that potential exposures to
humans is 13,000 times less than the exposure to rats at which no adverse effects
were observed. Rats have also demonstrated an increased sensitivity compared to
humans to thyroid induced tumors which adds an even greater comfort level to
the significance of the calculated MOE.
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Dietary Exposure
People may be exposed to residues of thiabendazole through the diet Tolerances
or maximum residue limits have been established for the following agricultural
and livestock commodities in 40 CFR§180.242: apples (post-harvest), avocados,
bananas (pre and post-harvest), banana pulp (pre and post-harvest, dry beans,
sugar beets pulp (dried/and or dehydrated), sugar beets tops (pre-harvest), sugar
beets tops, cantaloupes, carrots (post-harvest), citrus fruits (post-harvest), citrus
pulp dried (post-harvest), mangos, mushrooms, papayas (post-harvest), pears
(post-harvest), potato processing waste (pre and post-harvest), potatoes (pre and
post-harvest), rice hulls, rice rough, rice straw, soybeans, strawberries, sweet
potatoes (post-harvest to sweet potatoes only intended for use as seed), Hubbards
squash, wheat grain, wheat milled fractions (except flour), wheat straw, cattle fat,
meat byproduct, meat; eggs, poultry meat, meat byproduct; goats fat, meat
byproduct, meat; hogs fat, meat byproduct, meat; horses fat, meat, meat
byproduct; milk, sheep fat, meat byproduct and meat EPA has assessed the
Thiabendazole tolerances and found that some are acceptable, others must be
revoked. The Agency is proposing to revoke the tolerances for residues in
poultry meat, meat by products and eggs. Based upon the maximum dietary
burden for poultry and data, tolerances for residues in poultry meat, meat by
products, and eggs should be revoked. In addition, based upon the maximum
dietary burden for beef cattle and swine and data, tolerances for residues in fat of
cattle, hogs, horses, goats and sheep should be revoked.
The Agency is proposing to revoke the tolerance for thiabendazole residues in
banana pulp. The tolerance already established for bananas will include the
banana pulp. New tolerances must be established for residues in/on wet apple
pomace, citrus oil, pome fruits, wheat forage and hay. Residue data is required
before an appropriate tolerance can be determined for residues in/on wheat forage
and hay; however, sufficient data is currently available to determine the
appropriate tolerance for residues in wet apple pomace and citrus oil.
The registrant is not supporting domestic treatment of thiabendazole on sugar beet
raw agricultural commodities (RACs), grapes, rice RACs, processed fractions,
and Hubbards squash, and therefore these tolerances should all be revoked. The
Agency is proposing to revoke tolerances for residues in dried citrus pulp, potato
processing waste, and wheat milled fractions since thiabendazole does not
concentrate in potato, wheat processed fractions, and dried citrus pulp in excess of
the tolerance on whole citrus fruits.
Risk From Food
For thiabendazole, acute, chrornc, and carcinogenic dietary risk from food is not
of concern.
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Risk From Food +Drinking Water
Model estimates of potential drinking water exposure from ground and surface
water sources are not of concern for thiabendazole. Also, acute and chronic
dietary risk is below the Agency's level of concern. Therefore, risks from food
and drinking water combined are below the Agency's level of concern.
Risk From Non-dietary Exposure
There are no thiabendazole pesticide products registered for use by homeowners.
Thiabendazole-treated carpets and paints, can however, be used by homeowners.
The Agency does not believe that homeowners exposed to thiabendazole-treated
carpets are at a risk since thiabendazole is applied to the backing of carpets during
the manufacturing process and estimates are extremely conservative. Also, due to
thiabendazole's use profile, the Agency has concluded that there is a low potential
for residential exposure. The low concentrations of thiabendazole incorporated in
paints, adhesives, paper and carpet greatly reduces the potential for exposure. In
all cases, residential exposure is not expected to exceed occupational post-
application exposure and therefore would not be expected to exceed the Agency's
level of concern.
Aggregate Risk
The short- and intermediate-term aggregate risk assessment includes exposure,
from nonoccupational settings in addition to the dietary (food and water)
exposure. Two short-term (1-7 days) and intermediate term (1-6 months)
exposure scenarios were identified for the adult populations: exposure to
thiabendazole-treated carpets and paints. These two scenarios were aggregated
with the average dietary exposure since they can occur simultaneously. For
infants and children, only the carpet exposure was aggregated with average
dietary exposure. Estimated average concentrations of thiabendazole in surface
and ground water are below the Agency's level of concern.
Occupational Risk
Based on current use patterns, handlers (mixers, loaders, and applicators) may be
exposed to thiabendazole applications in agricultural and other settings. However,
the Agency has concluded that there is low potential for residential exposure.
The low concentrations of thiabendazole incorporated in paints, adhesives, paper
and carpet greatly reduces the potential for exposure. The margin of exposure
(MOE) for all residential and occupational scenarios is well below the Agency's
level of concern, and therefore risk is minimal.
Exposure and risk to workers will be mitigated by the use of PPE required by the
WPS, as required by this RED. Post-application reentry workers will be required
to observe a 12 hour Restricted Entry Interval, which is set by the WPS.
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FQPA Considerations
EPA has determined that the established tolerances for thiabendazole, with
amendments and changes as specified in this document, meet the safety standards
under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is
reasonable certainty of no harm for infants and children. The safety determination
for infants and children takes into account the possibility of increased dietary
exposure due to the specific consumption patterns of infants and children, as well
as the possibility of increased susceptibility to the toxic effects of thiabendazole
residues in this population subgroup.
Environmental
Assessment
In determining whether infants and children are particularly susceptible to toxic
effects from thiabendazole residues, EPA considered the completeness of the
database for developmental and reproductive effects, the nature of the effects
observed, and other information, for thiabendazole, the FQPA safety factor of 10
was reduced to 1 because: (1) the toxicity database includes an acceptable two-
generation reproduction study in rats and acceptable prenatal developmental
toxicity studies in rats and rabbits. These studies show no increased sensitivity to
fetuses as compared to maternal animals following acute in utero exposure in the
developmental rat and rabbit studies and no increased sensitivity to pups as
compared to adults in a multi-generation reproduction study in rats. (2) There was
no evidence of abnormalities in the development of the fetal nervous system in
the pre/post natal studies. Adequate actual data, surrogate data, and/or modeling
outputs are available to satisfactorily assess dietary and residential exposure and
to provide a screening level drinking water exposure assessment. (3) The Agency
believes that its exposure assessments will not underestimate the potential risk for
infants and children from thiabendazole. Therefore, the additional 10X factor as
required by FQPA was reduced to IX.
Ecological Effects
Thiabendzole is highly toxic to freshwater estuarine fish and freshwater/estuarine
invertebrates. Thiabendazole is practically non-toxic to birds and mammals.
Typically, birds and mammals can be exposed to pesticides applied as foliar
sprays or granulars by a variety of routes, including ingestion, dermal contact, and
inhalation. For thiabendazole, which is applied indoor as a seed treatment for
wheat, exposure to wildlife is not relevant until treated seeds are planted back in
the fields. Applications to and treatment of mushroom houses are also indoor
uses, and therefore are of minimal danger to birds and mammals. Exposure of
terrestrial wildlife from direct injection of thiabendazole and its salts into trees
may occur but is also expected to be a minimal means of exposure. Results of
avian reproduction studies on northern bobwhite quail and mallard duck yielded
results that show thiabendazole having no adverse effects on avian reproduction.
"The ecological risks due to the use of thiabendazole are considered below the
Agency's level of concern. Currently registered use patterns for thiabendazoie
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Risk Mitigation
Additional Data
Required
result in low exposures and with the relatively low toxicity of thiabendazole, no
environmental mitigation is necessary.
To lessen the risks of dietary exposure posed by thiabendazole, EPA is
requiring the following risk mitigation measures:
-To mitigate acute dietary risk to children 1-6 years of age, Syngenta
amended the label to remove the spray application to mushrooms.
To lessen the risks of occupational exposure posed by thiabendazole, EPA
is requiring the following risk mitigation measures:
-To mitigate risks to agricultural workers (applicators) during spray
application to mushroom houses:
- label language will be changed to speciiy chemical resistant gloves be
worn while applying thiabendazole to mushroom houses during spawning
only.
-To mitigate risks to agricultural workers (mixers/loaders/applicators) during
manual seed treatment:
-since this use was found to be virtually non-existent. The Agency will be
changing the label language to prohibit this use.
-To mitigate risks to agricultural workers during post-harvest
sorting/packing/culling of fruit:
-the Agency recalculated exposure numbers for workers
sorting/culling/packing after harvest based on transfer coefficiency
information that was not available at the time of the original assessment
The newer data provided an MOE of 1600, well below the Agency's level
of concern and therefore no additional risk mitigation is necessary.
EPA is requiring the following additional generic studies for thiabendazole
to confirm its regulatory assessments and conclusions:
(1) In vitro mammalian gene mutation (870.5300)
(2) In vitro chromosome aberration assay (870.5375)
(3) Chemical Identity: Revised CSF (830.1550)
(4) UV/visible absorption (830.7050)
(5) Multi-residue method testing (860.1360)
(6) Additional storage stability data for sweet potatoes (860.1380)
(7) Additional residue data for benzimidazole (free and conjugated) in/en
cantaloupe and strawberry for foliar application (860.1500)
(8) Residue data on wheat, dry beans, and soybeans (860.1500)
(9) Processing study for the processed fractions of soybeans (860.1520)
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of Formaia
(CSFs), and revised labeling for reregistration.
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Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
All thiabendazole end-use products must comply with EPA's current
pesticide product labeling requirements. For a comprehensive list of labeling
requirements, please see the thiabendazole RED document
The use of currently registered products containing thiabendazole in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment Therefore, all uses of these products are
eligible for reregistration.
Thiabendazole products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised labeling
are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for thiabendazole during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513^89-
8695.
Following the comment period, the thiabendazole RED document also will
be available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-^605-
6000.
For more information about EPA's pesticide reregistration program, the
thiabendazole RED, or reregistration of individual products containing
thiabendazole please contact the Special Review and Reregistration Division
(7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pro Eastern Standard
Time, seven days a week. Their internet address is http://npic.orst.edu.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
APR 1 3 2004
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments received
related to the preliminary and revised risk assessments for the pesticide thiabendazole. Based on
EPA's review, the Agency believes risk mitigation measures have been identified that are
necessary to address the human health risks associated with the current use of thiabendazole.
The EPA is now publishing its reregistration eligibility, risk management, and tolerance
reassessment decisions for the current uses of thiabendazole and its associated human health and
environmental risks. The enclosed " Reregistration Eligibility Decision for Thiabendazole,"
which was approved on May 1, 2002, contains the Agency's decision on thiabendazole.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for thiabendazole
is being published in the Federal Register. To obtain a copy of the RED document, please contact
the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania
Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED
and all supporting documents are available on the Internet. See http:www,epa.gov/
pesticides/reregi strati on.
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for pesticides. As part of the Agency's effort to involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets on pesticides and to engage the public in the
reregistration and tolerance reassessment processes for these chemicals. The U.S. Department of
Agriculture held a meeting in conjunction with the Agency on August 15, 2001, and provided the
Agency with information on thiabendazole usage and use/agricultural practices. The human
health and environmental risk assessments were placed in the public docket and an invitation for
public comment was announced in the Federal Register on August 30, 2001. In addition, a
second conference call was held September 27, 2001 during which the Agency presented a
summary of the risk assessments and risk management decisions for the registrants, USDA, and
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other stakeholders. Finally, the Agency held the closure conference call for thiabendazole on
March 20,2002 in order to provide all stakeholders involved with the Agency's final risk
management decisions.
Please note that the thiabendazole risk assessment and the attached RED concern only this
particular chemical. Thiabendazole is a member of the benzimidazole class of fungicides. While
current data are limited, EPA has evidence that compounds within a class may share a common
mechanism of toxicity. At this time, the Agency does not have sufficient data concerning
common mechanism issues to determine whether or not thiabendazole shares a common
mechanism of toxicity with other substances, including other benzimidazoles or other probable
human carcinogens. Therefore, for the purposes of this risk assessment, the Agency has assumed
that thiabendazole does not share a common mechanism of toxicity with any other chemicals.
This document contains a draft copy of the generic and/or a product-specific Data Call-ln(s)
(DCI) that omline(s) further data requirements for this chemical. Note that a final DCI, with all
pertinent instructions, is being sent to all applicable registrants under separate cover.
In this RED, the Agency has determined that thiabendazole will be eligible for reregistration
provided that all the conditions identified in this document are satisfied, including implementation
of the risk mitigation measures outlined in Section IV of the document. The Agency believes that
current uses of thiabendazole may pose unreasonable adverse effects to human health, and that
such effects can be mitigated with the risk mitigation measures identified in this RED.
Accordingly, the Agency recommends that registrants implement these risk mitigation measures
immediately. Sections IV and V of this RED describe labeling amendments for end-use products
and data requirements necessary to implement these mitigation measures. Instructions for
registrants on submitting the revised labeling can be found in the set of instructions for product-
specific data that accompanies this RED.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by thiabendazole.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern. At that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the proposed label changes necessary for
reregistration, please contact the Chemical Review Manager, John W. Pates, Jr., at (703)308-8195
For questions about product reregistration and/or the product DCI that accompanies this
document, please contact Moana Appleyard at (703) 308-8175.
Sincerely,
Attachments
Lois A. Rossi, Director
Special Review and
Reregistration Division
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Reregistration Eligibility Decision
for
Thiabendazole
and
Salts
Case 2670
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Table of Contents
Executive Summary v
I. Introduction 1
II. Chemical Overview 2
A. Chemical Identification 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Regulatory History 5
III. Risk Assessments for Thiabendazole .., 5
A. Human Health Risk Assessment 5
1. Toxicity of Thiabendazole 5
2. Dose Response Assessment 6
a. Summary of Endpoints Selected 6
b. Acute Dietary Endpoint 7
c. Chronic (non-cancer) Dietary Endpoint 7
d. Chronic (cancer) Dietary Endpoint 7
e. FQPA Safety Factor 7
3. Hazard Determination 8
a. Acute PAD 8
b. Chronic (Non-cancer) PAD ' 8
c. Chronic (Cancer) MOE Approach 8
4. Exposure Assumptions 9
5. Dietary Risk from Food 9
a. Acute Dietary Risk 9
b. Chronic (Non-Cancer) Dietary Risk 30
c. Chronic (Cancer) Dietary Risk 10
6. Dietary Risk from Drinking Water 11
a. Surface Water 11
b. Ground Water 12
c. Drinking Water Levels of Comparison (DWLOCs) 12
d. DWLOCs for Acute Exposure 12
e. DWLOCs for Chronic Exposure 13
1. Residential (Homeowner) and Other Non-occupational Risk 13
a. Residential Handler Risk 14
b. Residential Post-application Risk 15
8. Aggregate Risk 15
a. Acute Aggregate Risk 15
b. Short-term and Intermediate-term Aggregate Risk 15
c. Chronic (Non-cancer) Aggregate Risk 15
d. Chronic (Cancer) Aggregate Risk 16
9. Occupational Risk 16
10. Occupational Toxicity 16
a. Occupational Exposure 17
(1) Occupational Handler Risk 18
b. Post-application Risk 21
c. Human Incident Reports 22
B. Environmental Risk Assessment 22
I. Environmental Fate Characterization , 22
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a. Fate in Soil 22
b. Fate in Water 23
c. Persistence and Bioconcentration 23
d. Mobility 23
2. Drinking Water Assessment 23
3. Aquatic Exposure and Risk Assessment 23
a. Risks to Fish and Aquatic Invertebrates 24
b. Risk to Aquatic Plants 24
4. Terrestrial Exposure and Risk Assessment 24
a. Risks to Birds and Small Mammals 25
IV. Risk Management and Reregistration Decision 25
A. Determination of Reregistration Eligibility 25
B. Tolerance Reassessment 26
C. Regulatory Position 26
1. Food Quality Protection Act Findings 26
a. "Risk Cup" Determination 26
b. Determination of Safety for U.S. Population 27
c. Determination of Safety for Infants and Children 27
d. Endocrine Disruptor Effects 28
e. Cumulative Risks 28
D. Tolerances Summary 28
1. Tolerances Listed Under 40 CFR § 180.242(a) 29
2. Tolerances Listed Under 40 CFR § 180.242(a) to be Revoked 29
3. Tolerances Listed Under 40 CFR § 180.242(b) 29
4. Tolerances listed under 40 CFR § 180.242(b) to be Revoked 30
5. New Tolerances to Be Established under 40 CFR §180.242 (a) 30
6. Codex Harmonization 33
7. Residue Analytical Methods 34
E. Human Health Risk Mitigation 34
1. Dietary Risk Mitigation 34
a. Acute Dietary (Food) 34
b. Chronic (Non-cancer) Dietary (Food) 34
c. Chronic (cancer) Dietary 35
d. Dietary (Drinking Water) 35
2. Non-occupational Risk Mitigation 36
a. Non-occupational Non-cancer 36
b. Non-occupational Cancer 36
3. Aggregate Risk Mitigation 36
a. Acute Aggregate Risk 36
b. Short-term and Intermediate-term Aggregate Risk 37
c. Chronic (Non-cancer) Aggregate Risk 37
d. Chronic Cancer Aggregate Risk 37
4. Occupational Risk Mitigation 37
a. Handler Exposure 37
(1) Spray Application to Mushroom Houses 38
(2) Manual Seed Treatment 38
(3) Post-Harvest Sorter/Packers/Culling of Fruit 38
5. Environmental Risk Mitigation 38
F. Other Label Statements 39
1. Endangered Species Statement 39
V. What Registrants Need to Do 39
A. Manufacturing-Use Products 41
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1. Additional Generic Data Requirements 41
2. Labeling for Manufacturing-Use Products 41
B. End-Use Products 41
1. Additional Product-Specific Data Requirements 41
2. Labeling for End-Use Products 42
C. Existing Stocks 42
D. Labeling Changes Summary Table 42
VI. Related Documents and How to Access Them 45
VII. APPENDICES 47
Appendix A. Thiabendazole Table of Use Patterns Eligible for Reregistration
48
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 53
Appendix C. Technical Support Documents 58
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography) 60
Appendix E. Generic Data Call-In 73
Appendix F. Product Specific Data Call-In 81
Appendix G. EPA's Batching of Thiabendazole Products for Meeting Acute
Toxicity Data Requirements For Reregistration 96
Appendix H. List of Registrants Sent This Data Call-In 101
Appendix I. List of Available Related Documents and Electronically Available
Forms 103
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TH1ABENDAZOLE TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Suhair Shallal
Thurston Morton
David Jaquith
Environmental Fate Risk Assessment
Thuy Nguyen
William Erickson
Henry Nelson
Use and Usage Analysis
Istanbul Yusuf
Tara Chand-Goyal
Registration Support
Cynthia Giles-Parker
Maria Rodriguez
Risk Management
Lorilyn Montford
Mark Wilhite
Reregistration Branch IV
Reregistration Branch IV
Reregistration Branch IV
Environmental Risk Branch III
Environmental Risk Branch III
Environmental Risk Branch III
Economic Analysis Branch
Antimicrobials and Plant Pathogens Branch
Fungicide Branch
Fungicide Branch
Reregistration Branch I
Reregistration Branch I
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
DCI Data Call-in
aPAD Acute Population Adjusted Dose
CAS Chemical Abstracts Service
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking
water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to
occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EFED EPA's Environmental Fate and Effects Division
e.g. Lot. Exampli gratia (for example)
EP End-Use Product
EPA . U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory. The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HED EPA's Health Effects Division
HOT Highest Dose Tested
i.e. Lot. Id est (that is)
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test arrmals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD5n Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOC Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contamin&iit Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
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MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PR Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Q,* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
TRR Total Radioactive Residue
UF Uncertainty Factor
jjg/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
111
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uv
WHO
WP
WPS
Ultraviolet
World Health Organization
Wettable Powder
Worker Protection Standard
IV
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Executive Summary
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of thiabendazole, and its salt, thiabendazole hypophosphate, hereafter referred
to as thiabendazole. EPA has completed its review of public comments on the revised risk
assessments and is issuing its risk management decisions for thiabendazole. The decisions
outlined in this document include the final tolerance reassessment decision for thiabendazole.
The revised risk assessments are based on review of the required target data base supporting the
use patterns of currently registered products and new information received. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before
the Agency issued its risk mitigation decision on thiabendazole. After considering the revised
risks, as well as mitigation proposed by Syngenta, the technical registrant of thiabendazole, and
comments and mitigation suggestions from other interested parties including American
Mushroom Institute, Florida-Fruit and Vegetable Association, Dole Food, Northwest Horticultural
Council, Florida Citrus Packers and a host of other stakeholders such as state agricultural
departments, agricultural extension organizations and universities, EPA developed its risk
management decision for uses of thiabendazole that pose risks of concern. This decision is
discussed fully in this document.
Use Summary
Thiabendazole is a fungicide used on a variety of fruit and vegetables to control mold, rot,
blight and stain, mainly as a post-harvest treatment. It is also used as a seed treatment and is used
to control Dutch elm disease and as a preservative in paints, carpets, textiles, paper products and
adhesives. Thiabendazole is used medicinally as a chelating agent to bind metals; in addition, it
is administered to treat several helminth species such as roundworms in livestock and humans.
However, medicinal uses of thiabendazole are regulated by FDA, and have not been included in
this reregistration document. First registered in 1969, thiabendazole is registered for use on
bananas, carrots, citrus fruits, mushrooms, pome fruits, potatoes, soybeans, and wheat. Usage
data from 1987 -1997 indicates an average domestic use of approximately 41,000 Ibs. a.i. per
year for pre-harvest usage and approximately 109,000 Ibs. a.i. per year for post-harvest usage,
Dietary Risks
EPA's human health risk assessment for thiabendazole indicates some risk concerns. The
preliminary dietary risk assessment indicated that acute dietary food risk was above the Agency's
level of concern for children 1-6 years of age, with mushrooms driving the risk. To mitigate this
risk the registrant has modified their label to delete the use of thiabendazole as a spray application
to mushrooms, and to apply the spray application only during the spawning stage of mushroom
growth. Deletion of the spray application use of thiabendazole to mushrooms results in an
acceptable acute dietary risk for children 1-6 years of age. Chronic dietary food risk is below the
Agency's level of concern. Similarly, drinking water risk estimates based on screening models,
from both ground and surface water for acute and chronic exposures, are not of concern.
Carcinogenicity Classification
The Agency has classified thiabendazole as likely to be carcinogenic at doses high enough
to cause disturbance of the thyroid hormone balance. It is not likely to be carcinogenic at doses
lower than those which could cause a disturbance of this hormonal balance. After considering the
expected exposure authorized under EPA currently registered use patterns as well as
consideration of allowable dietary exposure from imported crops treated with thiabendazole, the
Agency has determined that individuals would be exposed to levels which are far less than those
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sufficient to cause cancer. The Agency is using the MOE approach for the human cancer risk
assessment rather than a linear approach since the mode of action for the carcinogenic effect is
known and the pesticide does not produce tumors by a mutagenic mechanism. Use of Pesticide
Data Program (PDF) monitoring data, field trial data, tolerance level residues and calculated
livestock residues have resulted in a MOE of 13,000 for the general U.S. population which is
below the Agency's level of concern. (This MOE includes the deletion of the mushroom
overspray use.) A MOE of 13,000 means that potential exposures to humans is 13,000 times less
than the exposure to rats at which no adverse effects were observed. Rats have also
demonstrated an increased sensitivity compared to humans to thyroid induced tumors which adds
an even greater comfort level to the significance of the calculated MOE, Children are not
expected to be more susceptible to thiabendazole-induced thyroid effects than adults.
Acute and chronic dietary risk assessments for food and drinking water do not exceed the
Agency's level of concern; therefore, no mitigation is warranted at this time for any dietary
exposure to thiabendazole,
Occupational Risk
Occupational exposure to thiabendazole was of concern to the Agency during the
preliminary risk assessment for two occupational scenarios: manual seed treatment and post-
harvest sorting/packing/culling of fruit. Since the preliminary assessment, several changes have
occurred based on information that was not available to the Agency during the original
assessment.
First, manual seed treatment originally showed an MOE above the Agency's level of concern.
Since the original assessment, this use was found to be virtually nonexistent in the grower
community. Therefore, the Agency will be changing the label language to prohibit manual seed
use. Also, in the original assessment, the Agency determined that the post-harvest application
exposure to sorters/packers/cullers was above the Agency's level of concern. However, since that
time the Agency has received new transfer coefficiency data that indicates a 50 fold decrease in
exposure resulting in a 50 fold increase in the margin of exposure (MOE). Originally, the Agency
believed that personal protective equipment (gloves) were necessary during this occupational
scenario in order to protect sorters/packers/cullers from thiabendazole exposure. Now, the MOE
is well below the Agency's level of concern and therefore, no mitigation is necessary at this time.
Additionally, although the registrant, Syngenta, has deleted the mushroom oyerspray application,
there is still occupational concern for applicators applying thiabendazole during the spawning
stage of mushroom growth. Therefore, the use of chemical resistant gloves (PPE) will be
necessary for applicators applying thiabendazole during the spawning stage.
Ecological Risk
Ecological risks are not of concern to the Agency. Although thiabendazole is highly toxic
to fish and aquatic invertebrates and is very persistent in soils, the Agency believes that there will
be minimal potential risk to terrestrial animals or aquatic animals resulting from the use of this
fungicide to control diseases in mushrooms, as a seed treatment, and as a post-harvest treatment.
In addition, the Agency does not expect parent thiabendazole and its degradates to enter the
drinking water resources at any significant level.
The Agency is issuing this Reregi strati on Eligibility Document (RED) for thiabendazole,
as announced in a Notice of Availability published in the Federal Register. This RED document
includes guidance and time frames for complying with any necessary label changes for products
containing thiabendazole. The Agency provided a public comment period for this chemical. The
comment period lasted 60 days. It began on July 30,2001 and closed October 1, 2001.
VI
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I.
Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or the Agency). Reregistration involves a
thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on health and environmental effects;
and to determine whether the pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment of all existing tolerances. The Agency
had decided that, for those chemicals that have tolerances and are undergoing reregistration, the
tolerance reassessment will be initiated through this reregistration process. It also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA, which was August 3,1996. FQPA also amends the FFDCA to require a safety finding in
tolerance reassessment based on factors including an assessment of cumulative effects of
chemicals with a common mechanism of toxicity. Although FQPA significantly affects the
Agency's reregistration process, it does not amend any of the existing reregistration deadlines.
Therefore, the Agency is continuing its reregistration program while it resolves the remaining
issues associated with the implementation of FQPA.
This document presents the Agency's revised human health and ecological risk
assessments; its tolerance reassessment decision; and the decision on the reregistration eligibility
ofthiabendazole.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section III gives an overview of the revised human health and environmental effects
risk assessments resulting from public comments and other information. Section IV presents the
Agency's decision on reregistration eligibility and risk management decisions. Section V
summarizes the label changes necessary to implement the risk mitigation measures outlined in
Section IV. Section VI provides information on how to access related documents. Finally, the
Appendices lists Data Call-In (DCI) information. The revised risk assessments and related
addenda are not included in this document, but are available on the Agency's web page
www.epa.gov/pesticides, and in the Public Docket.
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II. Chemical Overview
A. Chemical Identification
• Common Name:
• Chemical Name:
• Chemical family:
• Case number:
• CAS registry number:
• OPP chemical code:
• Empirical formula:
• Molecular weight:
• Trade and other names:
• Basic manufacturer:
Thiabendazole
[2-(4-thiazolyl) benzimidazole]
[2-(4-thiazolyl) benzimidazole] hypophosphite salt
Benzamidazole
2670
148-79-8
28558-32-9
060101
060102 (hypophosphite salt)
C10H7N3S
201.26
Mertec, Arbotect, Vitavax, Agrosol,, Metasol,
Sealbrite
Syngenta
Technical thiabendazole is a colorless crystalline solid with a melting point of 304-305 C,
bulk density of 25-30 cc (tapped), octanol/water partition coefficient (K^) of 240-285 at pH7,
and vapor pressure of 4 X 10'9 mm Hg at 25C. Thiabendazole is soluble in water at 0.028-0.030
mg/mL at 25C, and is soluble in several organic solvents.
B. Use Profile
The following information is based on the currently registered uses of
thiabendazole:
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Type of Pesticide
Fungicide
Use Sites:
Thiabendazole is registered for use as a pre-planting dust treatment to the following types
of seeds: potato seed-pieces, sweet potato seed-pieces, soybean, and wheat. It is also
registered for use on mushrooms for irrigation applications. In addition, thiabendazole is
registered as a spray and dip application during the waxing procedure for the following
fruits and vegetables: peas (field), peas (dried), citrus fruits, avocados, lemons, apples,
pears, bananas, mangos, papaya, plantain, carrots (root crop vegetable), potatoes, sweet
potato, beans (dried), crimson clover (forage fodder), and rice. Thiabendazole salt uses
include a ready-to-use formulation for the following non-food uses: ornamental bulbs, elm
and sycamore trees. Thiabendazole salt is also used as a preservative in paints, carpets,
adhesives and textiles.
Target Pests:
A variety of molds, mildews, rot, blight and stains caused by various fungi including
species in the following genera: Verticillium fungicola, Mycogone perniciosa,
Trichoderma harzianum, Trichoderma virdi, Aspergillus, Trichoderma spp. and more.
Formulation Types Registered:
The following thiabendazole formulation types are registered: a ready-to-use, dusts,
flowable concentrates, emulsifiable concentrates, wettable powders, granules, and water
dispersable granules. End use products are sold in the U.S. under the trade names
Mertec® LSP, Mertec® 340-F, Arbotect® 20-S, Mertec® 40, Vitavax-Plus, Vitavax Extra,
Agrosol T, Granox Plus, Metasol TK-100, Calgon Thiabendzole Dispersion, Metasol TK-
25 AD, Metasol TK-50 AD, Citrus Lustre-256, Decco Salt No. 19, Gustafson LSP,
Freshguard 500 and many more.
Method and Rates of Application:
Post harvest applications can be done by dipping, spraying, or application during the
waxing procedure for fruits and vegetables. Seed treatments are applied with a ready-mix
or slurry seed treatment. A dusting machine is also used for seed treatments. A ready-to-
use formulation is mixed into paints, carpets, adhesives and textiles. A soluble
concentrate is diluted with water for injection of dutch elm and sycamore trees.
Use rates vary widely depending on the crop/target, as follows:
For wheat seed treatment:
2.0 - 6.0 fl. oz. ai per equal amounts of water
For chickpeas treatment:
14.0 fl. oz. ai per equal amounts of water
For mushroom treatment:
0.24 - 0.61 lb.ai/1000 sq.ft.
For pome fruits (apples and pears) treatment:
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16.0 fl. oz. ai per 100 gallons of water
For potato treatment:
0.42 fl. oz. ai per gallon of water
For ornamental bulbs and corms treatment:
30 fl. oz, per 100 gallons of water
For elm and sycamore tree treatment: (minimum to maximum)
(For each 5 inches of trunk diameter, inject 1 fl. oz. ai per 40 fl. oz. of water -
For each 5 inches of trunk diameter, inject 4 fl. oz. ai per 80-160 oz. of water)
For paints, carpets, and adhesive treatment:
range from 0.04% to 0.20% diluted product per 1 gallon of adhesive, paint, or
carpet.
Use Classification:
General Use Pesticide
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of
thiabendazole, based on available pesticide usage information for 1987 -1997. A full listing of
all uses of thiabendazole, with the corresponding use and usage data for each site, has been
completed and is in the "Quantitative Use Assessment" document, which is available in the public
docket. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use
patterns as well as the variability in using data from various information sources. Approximately
150,000 Ibs. a.i. of thiabendazole are used annually, according to registrant and Agency
estimates. Table 1 below does not include all representative crops for thiabendazole. Mushrooms
have not been included in Table 1 because they are cultivated indoors, and data collected on
indoor crops contain a wide range of reporting variability.
Table 1. Thiabendazole Estimated Usage for Representative Sites
Crop :- :- •.r^12^&
Apples
Potatoes
Pears
Bananas
Grapefruit
Oranges
Wheat, Winter
Peanuts
''^I^^A^Veil&gr^^il^waj;!
15,448
76,473
76,473
14
1,591
7,559
5
2
$BStf*r<^
62% (pre-storage)
23% (post-storage)
50% (pre-storage)
90% (pre-storage)
50% (post-storage)
45% (post-storage)
75% (post-storage)
<1
<1
'Weighted Average is based on data for 1987-1997; the most recent years and more reliable data are weighted more
heavily.
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D. Regulatory History
Thiabendazole was first registered in the United States in 1969 by Merck and Company,
Incorporated, The chemical was formulated as Mertect® Antimyotic. Merck and Company, Inc.
manufactured the technical product and other companies manufactured end-use products. The
primary registrant of end use products has been Syngenta Crop Protection, Incorporated. Merck
and Company, Inc. held the registration of the technical product until 1998. The registration for
the technical product was later transferred to Syngenta Crop Protection, Inc. but retained its name
as Mertect Fungicide.
III. Risk Assessments for Thiabendazole
The following is a summary of EPA's revised human health and ecological risk findings
and conclusions for the pesticide Thiabendazole, as presented fully in the documents,
"Thiabendazole (060101) and Thiabendazole Salts (060102): A Revised HED Risk Assessment
for the Registration Eligibility Decision (RED) Document," dated June 21,2001, and "EFED
Reregistration Document for Thiabendazole. "dated February 4, 1999.
The purpose of this decision document is to summarize the key features and findings of
this risk assessment in order to help the reader better understand the conclusions reached in the
assessment. While the risk assessments and related addenda are not included in this document,
they are available on the Agency's web page at www.epa.gov/pesticides, and in the OPP Public
Docket.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for thiabendazole and its salts in July 2001
(Phase 3). In response to comments and studies submitted during Phase 3, the risk assessments
were updated and refined.
1. Toxicity of Thiabendazole
The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database for thiabendazole is complete, supports a reregistration eligibility determination
for all currently registered uses. Further details on the toxicity of thiabendazole can be found in
the HED toxicology chapter for the Reregistration Eligibility Decision document (RED) dated
October 12,1999.
Thiabendazole has low acute toxicity via the oral and dermal routes (Category III). It is
not an eye or dermal irritant nor a dermal sensitizer. Thiabendazole has little opportunity for
vaporization or aerosolization since it is used for direct injection in root flares. Therefore, there is
negligible risk of inhalation exposure to vapor or aerosol during use. Thiabendazole base is
known to have a very low vapor pressure and is not expected to contribute greatly to exposures
via the inhalation route. In primary eye and primary skin irritation studies, thiabendazole was
found to be non-toxic.
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The Agency has classified thiabendazole as "likely to be carcinogenic at doses high
enough to cause a disturbance of the thyroid hormone balance. It is not likely to be carcinogenic
at doses lower than those which could cause a disturbance of this hormonal balance." A mode of
action was established in which these tumors were attributed to interference with thyroid-pituitary
homeostasis. The MOE approach is used in this risk assessment to estimate the cancer risk.
Thiabendazole also causes increased liver weight and hepatocellular hypertrophy presumably via
induction of microsomal enzymes. However, thiabendazole is not a mutagen. In a chronic rat
study, thiabendazole induced thyroid tumors in males. There is no evidence of increased
susceptibility of rat, rabbit, or mouse fetuses to in utero exposure in developmental studies.
Acceptable genetic toxicology studies on thiabendazole indicate that it is nongenotoxic/mutagenic
in vivo and in vitro assays. Therefore, the FQPA Safety Factor committee concluded that the
safety factor could be removed for thiabendazole.
2. Dose Response Assessment
The Agency evaluated the toxicology database of thiabendazole, and established acute and
chronic endpoints and reference doses for dietary exposure. Toxicological endpoints were
selected for various exposure scenarios which are summarized in Table 2. The absorbed fraction
of each exposure was calculated in order to convert dermal and inhalation exposures to an
equivalent oral dose using a dermal absorption rate of 60% and an inhalation absorption factor of
100%. Thiabendazole has been shown to induce thyroid tumors in male and female rats. The
Agency has concluded that thiabendazole is likely to be carcinogenic at doses high enough to
cause a disturbance of the thyroid hormone balance. It is not likely to be carcinogenic at doses
lower than those which could cause a disturbance of this hormonal balance. A mode of action
was established in which these tumors were attributed to interference with thyroid-pituitary
homeostasis.
a. Summary of Endpoints Selected
A brief overview of the studies used for the dietary risk assessment is outlined in Table 2.
Table 2. Summary of Toxicological Dose and Endpoints for Thiabendazole for Use in
Human Dietary Risk Assessment
Exposure
Scenario
Acute Dietary
(females 13+)
Acute Dietary
(general
aop illation)
Dietary
Cancer
Dietary
Endpotnt
(ntg/kg/day)
NOAEL=10
LOAEL=40
LOAEL- 40
NOAEL=10
LOAEL=30
NOAEL=10
LOAEL=30
FQPA
Safety Factor
IX
IX
IX
IX
UF
100
100
100
N/A
Study/Effect
Oral Developmental Study - Rat/ decreased fetal
body weight
Oral Developmental Study - Rat/ decreased
maternal body weight seen during gestation
(general population)
Combined Chronic Toxicity-Carcinogenicity/
based on decreased body weight gains and liver
hypertrophy
Combined Chronic Toxicity-Carcinogenicity/
based on increased incidence of thyroid follicular
cell adenomas and combined
ad enomas/carcinomas .
PAD
0 1
mg/kg/day
0.1
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b. Acute Dietary Endpoint
Two acute dietary endpoints were selected for thiabendazole: one for females 13+ and the
other for the general U.S. population. A developmental toxicity study was used to establish the
acute dietary endpoint for females 13+. The endpoint (NOAEL of lOmg/kg/day) was based on
decreased fetal body weight gains presumed after a single dose of thiabendazole. The LOAEL is
40mg/kg/day. The acute dietary endpoint selected for the general U.S. population was based on a
developmental rat study as well. The endpoint (NOAEL of lOmg/kg/day) for the general U.S.
population was based on decreased maternal body weight gain seen during the gestation period.
The LOAEL is 40mg/kg/day.
c. Chronic (non-cancer) Dietary Endpoint
The chronic dietary endpoint (NOAEL of 1 Omg/kg/day) was based on decreased body
weight gains and liver hypertrophy at the LOAEL of 3Omg/kg/day. Reduced body weight gains
for the mid and high dose males and high-dose females, respectively, compared to the controls
were observed at week 103. A reduced body weight gain was also noted at this time for the mid-
dose females.
d. Chronic (cancer) Dietary Endpoint
In accordance with the Cancer Assessment Review Committee, a non-linear, MOE
approach was used to characterize human health risk. A chronic toxicity/carcinogenicity study in
rats was used. Male rats had significant increasing trends for thyroid follicular cell adenomas and
combined adenomas/carcinomas, and significant differences in the pair-wise comparisons of the
90mg/kg/day dose group. There were also significant differences in the pair-wise comparisons of
the 30mg/kg/day dose group with controls. Female rats, had significant increasing trends in
thyroid follicular cell adenomas and combined adenomas/carcinomas. The study demonstrated
that thiabendazole induces thyroid adenomas in male rats at dosages of > 30 mg/kg/day. (Point of
Departure (POD) - 1 Omg/kg/day). The systemic LOAEL is 30mg/kg/day and is based on
reduced body weight and reduced body weight gains and liver hypertrophy. The systemic
NOAEL is 1 Omg/kg/day.
e. FQPA Safety Factor
The FQPA Safety Factor was reduced to IX based on the following factors: first, the
toxicity database includes an acceptable two-generation reproduction study in rats and acceptable
prenatal developmental toxicity studies in rats and rabbits. These studies show no increased
sensitivity to fetuses as compared to maternal animals following acute in ulero exposure in the
developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in
a multi-generation reproduction study in rats. There was no evidence of abnormalities in the
development of the fetal nervous system in the pre/post natal studies. Adequate actual data,
surrogate data, and/or modeling outputs are available to satisfactorily assess dietary and
residential exposure and to provide a screening level drinking water exposure assessment.
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Second, the Agency believes that its exposure assessments will not underestimate the potential
risk for infants and children from thiabendazole. Therefore, the additional 10X factor as required
by FQPA was reduced to IX.
3. Hazard Determination
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the Reference Dose (RiD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). The RfD is an estimated level of daily exposure to a pesticide
residue which, over a 70-year human life span, is believed to have no significant deleterious
effects. Where the FQPA SF has been removed (equivalent to IX), the acute or chronic RfD is
equivalent to the acute or chronic PAD, In the case of thiabendazole, the FQPA safety factor has
been removed (equivalent to a factor of IX) for the acute and chronic dietary assessments.
a. Acute PAD
Reference doses were established for the two acute dietary endpoints. For the first
population subgroup (general U.S. population), an acute RfD of O.lmg/kg/day was derived based
on decreased maternal body weight seen during gestation at the NOAEL of 10 mg/kg/day in the
developmental rat study, and an uncertainty factor (UF) of 100 (lOx for interspecies extrapolation
and lOx for intraspecies variation). The FQPA Safety Factor was removed (equivalent to a factor
of IX) for this population. Consequently, the acute PAD (aPAD) is numerically equivalent to the
acute RfD at 0. Img/kg/day for this population. For the second population subgroup (Females
13+), an acute RfD of O.lmg/kg/day was derived based on decreased fetal body weight at the
NOAEL of 10 mg/kg/day in the developmental rat study, and an uncertainty factor (UF) of 100.
The FQPA was removed . Consequently, the acute PAD (aPAD) is numerically equivalent to the
acute RfD at 0.1 mg/kg/day for this population.
b. Chronic (Non-cancer) PAD
A chronic (non-cancer) RfD of 0.1 mg/kg/day was derived based on a NOAEL of 10
mg/kg/day in the 2-Year Feeding/chronic carcinogenicity study in rats with an uncertainty factor
of 100 (lOx for interspecies extrapolation and lOx for intraspecies variation). The FQPA SF was
removed (equivalent to a factor of IX) for this population. Consequently, the chronic PAD
(cPAD) is O.lmg/kg/day.
c. Chronic (Cancer) MOE Approach
The Agency has classified thiabendazole as "likely to be carcinogenic at doses high
enough to cause a disturbance of the thyroid hormone balance. It is not likely to be carcinogenic
at doses lower than those which could cause a disturbance of this hormonal balance." This
classification is by the oral route and recommends in accordance with the Cancer Assessment
Review Committee, a non-linear, MOE approach to characterize the human health risk. This
extrapolation is supported by the weight-of-the evidence which suggests that thiabendazole may
interfere with thyroid-pituitary homeostasis. Children are not expected to be more susceptible
than adults.
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4. Exposure Assumptions
Revised acute and chronic dietary risk analyses for thiabendazole were conducted with the
Dietary Exposure Evaluation Model (DEEM™). DEEM incorporates consumption data
generated in USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-91. For
the acute dietary risk assessment, the entire distribution of single day food consumption events
was combined with a distribution of residues. This is known as a (Monte Carlo) probabilistic
analysis. Risk is reported at the 99.9th percentile of exposure to obtain a distribution of exposure
in mg/kg/day. For the chronic dietary risk assessment, the three-day average of consumption for
each sub-population is combined with average residues in commodities to determine average
exposure in mg/kg/day. Use of PDF monitoring data, field trial data, and calculated livestock
anticipated residues (ARs) were used in the assessment. Generally, a dietary risk estimate that is
less than 100% of the acute or chronic Population Adjusted Dose does not exceed the Agency's
risk concerns.
5. Dietary Risk from Food
a. Acute Dietary Risk
Acute dietary risk was calculated considering what is eaten in one day and the entire
distribution of residue values in food, A risk estimate that is less than 100% of the acute
Population Adjusted Dose (aPAD) (the dose at which an individual could be exposed on any
given day and no adverse health effects would be expected) does not exceed the Agency's
concern.
PDP monitoring data, field trial data, and calculated livestock anticipated residues (ARs)
were used in the assessment. Several commodities which had PDP monitoring data contained
overtolerance residues. An analysis was conducted by lowering these overtolerance residue
values to the tolerance for the given commodity. Non-blended food forms require decompositing
the PDP composite residue values. Decompositing these values resulted in overtolerance residue
values. Overtolerance values were set back to the tolerance. For partially blended food forms
which do not require decompositing, the original overtolerance values were used as is since no
clear pattern of tolerance violation was observed.
A Monte Carlo analysis was used to estimate acute dietary risk. The Monte Carlo analysis
is a highly refined probabilistic risk assessment that takes an entire distribution of consumption
events for individuals and multiplies it by a distribution of residues to obtain a distribution of
exposures in mg/kg/day. Truncating decomposited PDP data at tolerance, and using mushroom
field trial residues from the chemigation use, resulted in risk estimates below the Agency's level
of concern. The risk estimate for children 1-6 years of age, the highest exposed population
subgroup of concern, is 77% of the aPAD, and thus is not of concern. The results of the analysis
are shown in Table 3 below.
-------
Table 3. Acute Dietary risk (Food Only)
Subgroup
Children 1-6 years of age
All infants (<1 year)
Females (13-50 years)
99.9th PcTCcniilc
Probabilistic
Exposure
(mjf/kgfday)
0.117065
0.057494 ,
0.053284
%aPAD
117
57
53
99.9th Percentile
Probabilistic
(truncating at tolerance)
Exposure
-------
6. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground and surface water
contamination. EPA considers acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is
considered to be an unrefined assessment and provides a high-end estimate of risk. To determine
the maximum contribution from water allowed in the diet, EPA first looks at how much of the
overall allowable risk is contributed by food and then determines a "drinking water level of
comparison" (DWLOC) to ascertain whether or not modeled or monitored concentrations exceed
this level. Estimated environmental concentrations (EEGs) that are above the corresponding
DWLOC exceed the Agency's level of concern.
Since no thiabendazole water monitoring data were available, the EPA estimated
thiabendazole concentrations with Tier I screening model, GENEEC for surface water sources,
and SC1-GROW for groundwater sources. These models estimate levels of thiabendazole only,
and not its degradates. The results used in both models were based on seeds treated at a
maximum application rate of 3.6 oz ai/lOOlbs seed (0.2 Ibs ai/A) and one application. Results of
the acute and chronic drinking water assessments, EECs and DWLOCs are summarized in Tables
5 and 6.
a.
Surface Water
For surface water, GENEEC was used to estimate peak (acute) and 56-day concentrations
resulting from the use of treated wheat seeds planted in the field. Treatment to wheat seed is done
indoors, but drinking water concern may arise since the treated wheat seeds are later planted in
the fields. The GENEEC program uses basic environmental fate values and pesticide label
information to estimate the EECs in a one-hectare, two-meter deep pond following the planting of
the treated seeds in a 10 ha field. Seeds are treated indoor during storage, then later planted in the
field. Based on the fate properties, if available in the field after planting, thiabendazole should
not dissolve, but will predominantly move off-site on entrained sediments into surface water.
When it reaches surface water, thiabendazole is not expected to persist, especially in shallow and
clear water, as this chemical is extremely susceptible to direct photolysis (t Vi = 29 hours). The
run-off event occurs two days after planting. GENEEC takes into account adsorption to the soil
or sediment, degradation in soil before runoff, and degradation within the water body, then
reports estimated concentrations of thiabendazole in surface water. It is not certain on how deep
the seeds will be incorporated into the ground at planting. However, for this use, GENEEC
assumes no seed incorporation. For surface water, GENEEC estimates a peak concentration of
2.4 ppb and an average 56 day concentration of 1.6 ppb. These results were based on the 3.6 oz
ai/100 Ibs, and 90 Ibs of seed planted per one acre. It is important to note that estimations based
on the typical application rate results in a much lower peak EEC (less than 0.2 ppb).
11
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b.
Ground Water
Ground water concentrations of thiabendazole were estimated using the SCI-GROW (Tier
I) computer model. The extremely high soil-water partitioning coefficients K,, values of
thiabendazole tend to reduce the potential for this chemical to leach through soils and
contaminate ground water. This was confirmed in the terrestrial field studies, where no residues
of this fungicide were detected in the layers deeper than 12 inches. Model simulations indicate
less than 0.01 ppb of thiabendazole residues in ground water, based on a maximum application
rate of 3.6 oz. ai/lOOlbs.
The results of both surface and ground water model estimates and their comparisons with
the DWLOCs are summarized in Table 5, For more information on drinking water risks and the
calculations of the DWLOCs, see the Drinking Water Exposure section of the June 21, 2001
February 4, 1999 Revised Human Health HED Risk Assessment for the Reregistration Eligibility
Decision (RED) Document for Thiabendazole, as well as the Exposure Characterization section
of the February 4, 1999 section of the EFED Reregistration document for Thiabendazole.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by
food (and if appropriate, residential uses) then determines a "drinking water level of
comparison"(DWLOC) to determine whether modeled or monitoring levels exceed this level.
The Agency uses the DWLOC as a surrogate to capture risk associated with exposure from
pesticides in drinking water. The DWLOC is the maximum concentration in drinking water
which, when considered together with dietary exposure, does not exceed a level of concern. The
Agency's default body weight and water consumption values used to calculate DWLOCs are as
follows: 70 kg/2L (adult male), 60 kg/2L (adult female), 30 kg/lL (child) and 10 kg/1 L (infant).
The results of the Agency's drinking water analysis are summarized here. Details of this
analysis, which used screening models, are found in the Revised Health Effects Division (HED)
Human Human Health Risk Assessment," dated June 21, 2001,
d. DWLOCs for Acute Exposure
Acute DWLOCs were calculated based on the acute dietary exposure and default body
weights and water consumption figures. The EECs for surface water (GENEEC) were less than
the acute DWLOCs for all subpopulations. The table below presents the calculations for the
acute drinking water assessment.
12
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Tables. Summary of DWLOC Calculations for Acute Risk
Population
Subgroup
U.S. Population
Females 13-50
Children 1-6
Acute PAD
(mg/kg/day)
0.1
0,1
0.1
Food Exposure
(mg/kg/day)
0.057
0.053
0.76'
Allowable Water
Exposure
(mg/kg/day)
0.043
0.047
0.023
Ground Water
-------
a.
Residential Handler Risk
Table 7. Summary of Toxicological Endpoints and Other Factors Used in the Residential
Risk Assessments for tbiabendazole.
Assessment
Short-term (dermal
and inhalation)
Intermediate- term
dermal and
inhalation
Dose
(mgfltg/dsy)
NOAEL= 10
LOAEL= 40
NOAEL=10
LOAEL* 40
Endpoint
Based on decreased fetal body weight
Based on reduced body weight gains
and histopathological changes in the
bone marrow, liver and thyroid
Study
Oral Developmental
Toxicity - Rat
Fourteen Week Oral
Toxicity (Feeding)
Absorption fector
60% -Dermal
100% -Inhalation
60% - Dermal
100%- Inhalation
Homeowner handler assessments are completed using a single scenario based on the use
of short-sleeved shirts and short pants (i.e., common homeowner attire during the pesticide
application season). In addition, only short-term exposures are assessed, as the Agency does not
believe homeowners who apply paints that have been treated with thiabendazole will be exposed
for more than seven days, see Table 7 and 8. Also, the Agency does not believe that
homeowners exposed to thiabendazole treated carpets are at a risk since thiabendazole is applied
to the backing of carpets during the manufacturing process and estimates are extremely
conservative. For homeowner handler exposure assessments, the Agency does not believe a
tiered mitigation approach like that used for assessing occupational handler risk is appropriate.
Homeowners often lack access to personal protective equipment (PPE) and also do not possess
expertise in the proper use of PPE. Risk for this potentially exposed population is measured by a
Margin of Exposure (MOE) which determines how close the residential exposure comes to a No
Observed Adverse Effect Level (NOAEL). Generally, MOEs greater than 100 do not exceed the
Agency's risk concern.
Due to thiabendazole's use profile, the Agency has concluded that there is a low potential
for residential exposure. The low concentrations of thiabendazole incorporated in paints,
adhesives, paper and carpet greatly reduces the potential for exposure.
Thiabendazole is used as a preservative in the backing of carpets and estimates used in the
residential assessment overestimate actual exposure. In all cases, residential exposure is not
expected to exceed occupational post-application exposure and therefore would not be expected
to exceed the Agency's level of concern.
Table 8. Homeowner Uses: Risk Concerns*
Scenario
Applying paints containing TBZ to surfaces, paintbrush
Acres
N/A
Rate
5 g/gal: 2gal/day
Short-Term MOE
290
Combined dermal & inhalation MOEs
14
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b. Residential Post-application Risk
Thiabendazole can be used in carpets, paints, textiles and paper where exposure to adults
and children may occur. Exposure may result from applying paint to homes, and sitting, laying or
walking on carpets. As a result, both toddler, child, and adult risks were considered in the risk
assessment. The calculated dermal and inhalation exposure was found to be within the following
range: 100-1000 for adults, 59-590 for toddlers and 39-390 for infants.
8. Aggregate Risk
An aggregate risk assessment looks at the combined risk from exposure through both
food, and drinking water, as well as from exposures to residential and other non-occupational
sources (in this case, exposure to thiabendazole treated carpets and paints). Generally, all risks
from these exposures must be less than 100% of the acute and chronic PADs to be considered
acceptable to the Agency. For thiabendazole acute aggregate risk, chronic aggregate risk, short-
term, intermediate-term and cancer aggregate assessments were completed. Results of the
aggregate risk assessment are summarized here, and are discussed extensively in the document
entitled, "Thiabendazole and Thiabendazole salt: A revised HED Risk Assessment for the
Registration Eligibility Decision (RED) Document." dated June 21, 2001."
a. Acute Aggregate Risk
The acute aggregate risk assessment considers a one-day oral exposure from food and
water only. The estimated maximum peak concentrations of thiabendazole in surface water is 2.4
ppb which is below the Agency's DWLOC for all population subgroups. Therefore, acute
aggregate risk estimates do not exceed the Agency's level of concern.
b. Short-term and Intermediate-term Aggregate Risk
Two short-term (1-7 days) and intermediate-term (1-6 months) exposure scenarios were
identified for the adult populations: exposure to thiabendazole-treated carpet and paints treated
with thiabendazole. These two scenarios were aggregated with the average dietary exposure
since they can occur simultaneously. For infants and children, only the carpet exposure was
aggregated with average dietary exposure. Estimated average concentrations of thiabendazole in
surface and ground water are below the DWLOCs for thiabendazole in drinking water.
Therefore, the Agency concludes with reasonable certainty that residues of thiabendazole in
drinking water when considered with other sources of exposure would not result in unacceptable
levels of aggregate exposure.
c. Chronic (Noo-cancer) Aggregate Risk
The aggregate chronic dietary risk estimates include exposure to thiabendazole residues in
food and water. No chronic residential use scenarios were identified (no contributions from paint
residues were considered). Exposure from carpet may occur, however, this exposure is expected
15
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to dissipate over time. The aggregate chronic risk would be equal to or less than that calculated
for short-term and intermediate-term aggregate risk. Exposure to combined residues of
thiabendazole and its metabolites of lexicological concern based on a Tier 3 refinement using
average residues from field trial and percent crop treated data represent 2% of the cPAD for the
most highly exposed population subgroup (children 1-6 years of age and infants < 1 year).
Exposure to all other sub-population groups represents 1% of the cPAD. The estimated average
56-day concentration of thiabendazole in surface water is 0.52 ppb. This estimated average is
below the Agency's DWLOC for exposure to thiabendazole in chinking water. Therefore,
chronic aggregate risk estimates do not exceed the Agency's level of concern.
d. Chronic (Cancer) Aggregate Risk
In accordance with the Cancer Assessment Review Committee, the Margin of Exposure
(MOE) approach was used to assess cancer dietary risk. The results of the chronic (cancer)
dietary assessment indicate an MOE of 13,000 for the general U.S. population, and is below the
Agency's level of concern.
9. Occupational Risk Mitigation
Occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of thiabendazole include:
individual farmers or growers who mix, load, and/or apply pesticides, professional or custom
agricultural applicators. Risk for all of this potentially exposed population is measured by a
Margin of Exposure (MOE) which determines how close the occupational exposure comes to a
No Observed Adverse Effect Level (NOAEL). Generally, MOEs greater than 100 do not exceed
the Agency's risk concern. For occupational risk to thiabendazole, there are no long term or
cancer exposure occupational scenarios.
10. Occupational Toxicity
The toxicity of thiabendazole is integral to assessing the occupational and residential risks.
All risk calculations are based on the most current toxicity information available for
thiabendazole, including a 21-day dermal toxicity study. The toxicological endpoints, and other
factors used in the occupational and residential risk assessments for thiabendazole are listed
below, in Table 9.
16
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Table 9. Summary of Toxicological Endpoints and Other Factors Used in the Occupational
Risk Assessments for thiabendazole.
Assessment
Short-term dermal
and inhalation
Intermediate- term
dermal and
inhalation
Dose
(ing/kg/day)
NOAEL = 10
LOAEL = 40
NOAEL=10
LOAEL=40
Eadpoint
Based on decreased fetal body
weights
Based on reduced body weight
gains and histopathological
changes in the bone marrow, liver
and thyroid
Study
Oral Developmental
Toxicity - Rat
Fourteen Week Oral
Toxicity (Feeding)
Study
Absorption fector
60% -Dermal
100%- Inhalation
60%-Dermal
100%-Inhalation
Thiabendazole has low acute, toxicity (Category III) and is neither irritating to the eyes or
skin nor is a dermal sensitizer. Acute toxicity values are summarized below in Table 10.
Table 10. Acute Toxicity Profile for Occupational Exposure for Thiabendazole
Route- of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
Toxkity Category
III
III
Waived
IV
IV
IV
MRID - :
41258201
41258202
N/A
40789806
40789807
40271701
a. Occupational Exposure
Chemical-specific exposure data were not available for thiabendazole. Baseline dermal
and inhalation exposure assessments using PHED Version 1.1 surrogate data were use, see Table
11. For scenarios not covered by PHED, it was necessary to use data from studies found in the
scientific literature so risks to pesticide handlers were assessed using data from the Pesticide
Handlers Exposure Database (PHED). The quality of the data and exposure factors represents the
best sources of data currently available to the Agency for completing these kinds of assessments;
the application rates are derived directly from thiabendazole labels. The exposure factors (e.g.,
body weight, amount treated per day, protection factors, etc.) are all standard values that have
been used by the Agency over several years, and the PHED unit exposure values are the best
available estimates of exposure. Some PHED unit exposure values are high quality while others
represent low quality, but are the best available data. The quality of the data used for each
scenario assessed is discussed in the Human Health Assessment document for thiabendazole,
which is available in the public docket.
17
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(1) Occupational Handler Risk
Occupational exposure scenarios include potential exposure to handler (mixers, loaders,
applicators) during use or to persons entering treated sites after aplication is complete.
thiabendazole is a fungicide formulated as a powder, dry flowable, or an emulsifiable concentrate.
It is also used as a ready-to-use liquid for incorporation into paints, adhesives, textiles, and paper
products. Field application of thiabendazole can be aerial (fixed wing or helicopter), ground
boom, or by chemigation. Post-harvest application can be by dipping, spraying, or application
during the waxing procedure for fruits and avocados. It can also be mixed with paints and
adhesives or incorporated in the manufacture of textiles and carpeting.
EPA has determined that there are potential exposures to mixers, loaders, applicators, or
other handlers during ususal use patterns associated with thiabendazole. Based on the use
patterns major exposure scenarios were identified for thiabendazole:
planting potatoes
observer on tractor planting potato seed pieces
• filling duster for potato seed treatment/cutting potato seed pieces
manual seed treatment at farm
commercial seed treatment
mixing/loading for post harvest treatments
exposure during post harvest handling of treated commodities
applying paints containing thiabendazole to surfaces using a paintbrush
applying paints containing thiabendazole to surfaces using an airless sprayer
application to mushroom houses
mixing/loading for mushroom houses
post-application exposure to treated carpet, textiles, or paper
tree injection
Table 11. Summary of Agricultural Risk Estimates for Short-term and Intermediate-term
Exposure Scenarios
Exposure Scenario
(Scenario*)
Baseline Daily
Dose*
(rug/kg/day)
BaseUne
MOEs*
Risk Mitigation
Measures
Additional PPEC "
Daily Dose1
(mg/kg/day)
MOEV
Mixer/Loader Exposure and Dose Levels ( includes Cutters for potato seed treatment)
Filling duster for potato seed pieces, located outside facility
(Rockv seed)
Filling duster for potato seed pieces, located outside facility
(Clean seed)
Filling duster for potato seed pieces, located inside facility
fClean seed}
0.085
0.045
0.0078
120
222
1300
NA
NA
..-" NA
NA
NA
NA
18
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•J^:;:^^
•Si:!-:^
Cutting Potato Seed Pieces, Complete Operation Inside
Cutting Potato Seed Pieces, Cutter Inside and Duster Outside
Mixing/loading for post harvest treatment of commodities
Mixing/loading for mushroom treatment
':- Ba'siiunfi^ Da^jy. •
-:;::;:;:':;:;:::iIJDSej&:S;:::;:;:::
':'£:!(:mgy&g?;day]):;£i
0.0029
0.00072
0.011
0.030
•
3400
14000
910
333
.y|;;s:i-i:;:- siMieastires! ;$:::%v |.:
!?j!: v:$U3.diiioiiial :pPE* '£• :^
••^mg^g$day^ S
NA
NA
NA
0.0024
ill
. NA
NA
NA
4200
Applicator Exposures and Pose Levels (includes Observer for Potato Treatment)
Applying paints containing TBZ to surfaces, paintbrush
Applying paints containing TBZ to surfaces, airless sprayer
Planting potato seed pieces
Observer on tractor planting potatoes
Manual seed treatment
Commercial seed treatment
Application to mushroom houses
0.034
0.018
0.0026
0.0023
0.18
No dataf
0.13
290
560
3800
430
56
No dataf
77
NA
NA
NA
NA
NA
No dataf
0.089
NA
NA
NA
NA
NA
No dataf
112
Post Harvest and Post Application Exposures and Dose Levels \
Post harvest exposure during sorting/packing/culling
Post application exposure to treated carpet, textiles, or paper -
Adult
Post application exposure to treated carpet, textiles, or paper -
Toddler
Post application exposure to treated carpet, textiles, or paper -
Infant ,
0.31
o.oi-o.r
0.02-0.17
0.03-0.26
1600
100-
1000
59-590
39-390
'NA
NA
NA
NA
NA
NA
NA
NA
a Baseline Daily Dose (mg/kg/day)=BaseIine Daily Exposure (mg/day)/Body weight (70kg)
b Dermal MOE values calculated using the following equation: MOE = NOAEL (mg/kg/day), where dermal
NOAEL=10.0mg/kg/day and an MOE of 100 is required.
c Additional PPE consists of a single layer of clothing and gloves
d Daily Dermal Dose (mg/kg/day) =[(Unit Dermal Exposure (mg/lb ai)* Max. App. Rate (Ib ai/A) *Max.
Treated)/Bod Weight (70kg)]
e Derived from a literature study.
f Exposure not expected to be as low as manual seed.
19
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Exposure estimates derived in lieu of data are considered to be very conservative for the
following reasons: (1) it was assumed that all of the thiabendazole on the treated surface could be
transferred to the skin. The chemical is usually pan of a wax matrix and quantitative transfer to
the skin is unlikely; (2) the transfer coefficients for the hands were obtained from a field study in
which contact with contaminated foliage was highly probable; a conveyor belt line would be
unlikely to have such a high degree of contact (probably restricted to fingertips only). The MOE
resulting from this scenario may be mitigated to a level of lesser concern by requiring additional
PPE (double layer of clothing and chemical resistant gloves.) Provided that thiabendazole dermal
exposures are mitigated for the above specified exposure scenario with PPE, MOEs for
dermal/inhalation exposure/risk do not exceed the Agency's level of concern.
Anticipated use patterns and application methods, range of application rates, and daily
amount treated were derived from current labeling. Application rates specified on thiabendazole
labels range from 2 fluid ounces to 30 fluid ounces of active ingredient per acre in agricultural
settings. The Agency typically uses acres treated per day values that are thought to represent
eight solid hours of application work for specific types of application equipment.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protective equipment (PPE). The Agency typically evaluates all exposures
with minimal protection and then adds additional protective measures using a tiered approach to
obtain an appropriate MOE (i.e., going from minimal to maximum levels of protection). The
lowest suite of protection is baseline. If required (i.e., MOEs are less than 100), increasing levels
of risk mitigation (PPE) are applied. If MOEs are still less than 100, engineering controls (EC)
are applied. In some cases, EPA will conduct an assessment using PPE or ECs taken from a
current label. The levels of protection that formed the basis for calculations of exposure from
thiabendazole activities include:
Baseline PPE: Long-sleeved shirt and long pants, shoes and socks
Label: "Wear protective clothing and rubber gloves when handling."
Short-term and Intermediate-term occupational scenarios have been presented for
thiabendazole. Two short-term and intermediate-term scenarios require PPE to mitigate dermal
risks from handling and/or applying thiabendazole-containing products. PPE is required to
mitigate risk from dermal exposure during application in mushroom houses during the spawning
stage. Also, manual seed treatment has been identified as an occupational use scenario with
MOEs less than 100. The Agency believes that since this scenario is mostly non-existent, and has
been replaced with commercial seed treatment practices this it should be removed from the label.
The label language for manual seed treatment will be modified prohibiting its use.
One occupational scenario was not assessed by the Agency due to lack of TBZ-specific
occupational data for this method of application: Workers adding thiabendazole to paints and
carpets.
20
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Nonetheless, the Agency has qualitatively considered whether exposure is likely and
attempted to describe the level of risk from this scenario. For large paint operations, the addition
of thiabendazole to paint is done by computerized mechanical equipment. Workers are only
operating the computerized system and thiabendazole is added to the paint in an assembly line
fashion. No exposure is expected during large operations. For small paint operations,
thiabendazole is added to the paint can from water soluble bags. The paint is mixed in a kady
mill mixer. Thiabendazole is added at the end of the mixing process. Based on the Agency's
understanding of the smaller operations, workers are instructed to wear rubber aprons, gloves,
goggles and a face shield. As such, the Agency does not have a risk concern for workers adding
thiabendazole to paint.
b. Post-application Risk
Restricted-en try intervals (REIs) are calculated to determine the minimum length of time
required following an application before workers are allowed to reenter a treated area. Entry
restrictions are calculated to determine the minimum length of time required following an
application before crop workers are allowed to reenter a treated area with or without the use of
personal protective equipment to mitigate risks. REIs and entry restrictions are estimated in hours
or days.
Currently, for thiabendazole, the labels state a restricted entry interval of 12 hours.
Because thiabendazole is applied as a post-harvest dip for citrus, pome fruits, mango, bananas,
papayas, and avocados, and used as a preservative in paints and adhesives, the Agency has
concluded that there is a potential for occupational handler and post-application exposure risk. In
the preliminary risk assessment, only one of four scenarios of post-application exposure resulted
.in an MOE that exceeded the Agency's level of concern: post-harvest exposure during
sorting/packing/culling of fruit. Since the preliminary assessment, the Agency recalculated
exposure numbers for this scenario based on transfer coefficiency information that was not
available during the preliminary assessment. The newer data provided an MOE of 1600, well
above the Agency's level of concern. Given the new MOE, no mitigation through the use of
personal protective equipment will be necessary for this post-application scenario. Consequently,
because the Agency does not believe there is significant risk for post-application exposures
during son ing/packing/culling of fruit, the Agency believes that the minimum REI as established
under EPA's Worker Protection Standards (WPS) for 12 hours, is sufficient to protect workers
who may re-enter treated areas.
Occasionally, thiabendazole is applied as part of the manufacturing process for some
paper products, canvas textiles, and incorporated into carpets. Again, the Agency has no data that
addresses the potential exposure of these scenarios. Thiabendazole is applied during the
manufacturing process. Carpet would most likely yield the highest exposure. The fungicide is
applied via a trough during the manufacturing process to achieve a final level of 0.02-0.1%
(paper), 0.05-0.3% (canvas), or 0.025-0.25% (nylon carpeting). These figures are based on a
finished product weight. Since the Agency has no data that relates the weight of these products to
the surface areas that would lead to potential exposure, scientific literature measuring exposures
of individuals performing activities on carpets following actuation of a total release fogger was
21
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used. The Agency acknowledges that extrapolation from this study is highly uncertain and
requires several assumptions. For a thorough description of these assumptions and calculations
see the document entitled, "Revised Occupational and Residential Exposure Assessment and
Recommendations for The Reregistration Eligibility Decision Document for Thiabendazole
Incorporating Registrant and USDA Comments," dated September 14,2000,"
c. Human Incident Reports
The Agency has reviewed the OPP Incident Data System (IDS), the Poison Control
Center, the California Department of Food and Agriculture (Department of Pesticide Regulation),
and the National Pesticide Telecommunications Network (NPTN) databases for reported incident
information for thiabendazole. Two of three reports in the Incident Data System on thiabendazole
involve eye irritation. The Poison Control Center data for 1993-96 (400,000+ exposures to
pesticides) contains nine exposures to thiabendazole (six adults, two children under 6, and one 6-
19 year old). Only two of these exposures were reported to result in a minor medical outcome, 3
more were potentially minor or moderate but did not receive follow-up. Two had no symptoms
and two had unrelated symptoms. Only two cases were seen in a health care facility and none
was hospitalized. The California Department of Food and Agricultural data indicate that from
1982 through 1996, there were four cases of skin illness in packing/processing with
thiabendazole.
B.
Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For a
detailed discussion of all aspects of the environmental risk assessment, see the Environmental
Fate and Effects Division (EFED) chapter, dated February 4, 1999, available in the public docket,
and on the internet at www.epa.gov/pesticides . EPA issued its preliminary environmental risk
assessment for thiabendazole in February 1999. In response to comments and studies submitted
to the Agency, the risk assessment was updated and refined.
1. Environmental Fate Characterization
a. Fate in Soil
Thiabendazole is quite stable to photolysis in soil and to hydrolysis. It does not
metabolize significantly in soils, under aerobic and anaerobic conditions. Although it is shown to
be quite persistent in the environment, the Agency believes that thiabendazole will strongly bind
to soil due to its high soil/water partitioning coefficients, thus limiting the amount available for
leaching into ground water and for runoff into surface water. Three degradates were identified in
the aqueous photolysis study (benzimidazole-2-carboxamide as a major degradate; benzimidazole
and benzimidazole-2-carboxylic acid as minor degradates), two minor degradates in the aerobic
soil (bendimidazole) (see below). The only degradate that was analyzed for in the terrestrial
dissipation studies is benzimidazole, since it is the major metabolite in a soil study (anaerobic soil
metabolism). Test results showed that benzimidazole was not detected in any soil layers.
22
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b.
Fate in Water
Thiabendazole photodegrades in water. Thiabendazole, in aqueous pH 5 buffer solution
exposed to xenon lamp for 96 hours at 25°C, undergoes rapid photolytic degradation, with a half
life of approximately 29 hours. Photodegradation involves primarily the structural alteration of
the thiazole ring.
c.
Persistence and Bioconcentration
Thiabendazole appears to be extremely persistent in the environment. Extrapolated half-
lives ranged from 833-1100 days in cropped plots and from 1093-1444 days in bare-ground plots.
There was some trace levels of parent thiabendazole (up to 0.033 ppm; detection limit 0.01 ppm)
in the 6-12 inch soil depth in the study conducted on loamy sand soil cropped with wheat
(Washington) and on sandy loam soil with studies in Illinois.
d. Mobility
Based on the organic carbon normalized Freundlich values and the McCall's Mobility
Classification Scale, thiabendazole appears to have some mobility in sand (Koc=l 104 mg/L), silt
loam (Koc=l 813 mg/L), and sandy loam (Koc=3993 mg/L), but shows no mobility in clay
(Koc=22470 mg/L). The Freundlich adsorption coefficients (Kd's) are 2.76 mL/g in sand
(0.25%OC). 15.97 mL/g in sandy loam (1.2%OC), 21.75 mL/g in silt loam (1.2%OC), and 269,6
mL/f in xlY (1.2%ox). The desorption coefficients are 8.15 mL/g in sand, 19.46 mg/L in sandy
loam, 16.03 mg/L in silt loam, and 219.9 mL/g in 36 clay. No degradatewas observed.
2. Drinking Water Assessment
Thiabendazole should be of minimal threat to drinking water resources, as most registered
uses are indoors (i.e. use on mushrooms, and seeds) where leaching into ground water and runoff
to surface water is not likely to occur. The Agency believes that thiabendazole use will not
present any significant contamination to either surface water or ground water, and therefore, is
not of concern.
3. Aquatic Exposure and Risk Assessment
The GENEEC program uses basic environmental fate values and pesticide label
information to estimate the EECs in a one-hectare, two-meter deep pond following the planting of
the treated seeds in a 10 ha field. The runoff event occurs two days after planting. GENEEC
takes into account adsorption to the soil or sediment, degradation in soil before runoff, and
degradation within the water body, then reports estimated concentrations of thiabendazole in
surface water. It is not certain on how deep the seeds will be incorporated into the ground at
planting. However, for this use, GENEEC assumes no seed incorporation and a maximum seed
treatment rate of 3.6 oz ai/1 OOlbs to derive a conservative estimation. The EECs also assume that
thiabendazole is fully dissociated from the coats of the treated seeds after planting, and that there
is no spray drift.
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a. Risks to Fish and Aquatic Invertebrates
. The Agency compares risk quotients (RQs) to levels of concern (LOCs) to assess the
potential for adverse acute and chronic effects to aquatic organisms. A presumption of risk
occurs when an RQ equals or exceeds an LOG. The RQ is determined as follows:
RQ = EEC/toxicity value
For thiabendazole, the lowest LC50 (rainbow trout) is >0. Ippm but
-------
of exposure, as seed eating birds and small granivorous mammals uncover and consume the
treated seeds. It is uncertain how deep the seeds will be incorporated into the ground, however, if
the seeds were planted deep into the ground, threat to wildlife would be insignificant.
Applications to and treatment of mushrooms are also indoor uses, and therefore are of minimal
danger to birds and mammals. Exposure of terrestrial wildlife from direct injection of
thiabendazole and its salt into trees may occur but is also expected to be a minimal means of
exposure.
a.
Risks to Birds and Small Mammals
Thiabendazole is practically non-toxic to birds. (LD50s exceed 2000 mg/kg). Acute risk
for birds is not expected from the use of thiabendazole as a seed treatment for wheat or any other
crop. Chronic risk for birds is not expected, and chronic exposure should be minimal from a seed-
treatment use. In a chronic avian reproduction study it was indicated that chronic toxicity is not
likely. In a small mammal study using rats (oral study), thiabendazole was practically non-toxic.
LD50 values exceeded 2000 mg/kg. Avian reproduction studies on the northern bobwhite quail
and mallard duck yielded results that show thiabendazole having no adverse effects on avian
reproduction.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient specific) data required to support reregistration
of products containing thiabendazole as an active ingredient.
The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of products containing thiabendazole. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of thiabendazole and lists the submitted studies that the Agency found
acceptable. Data gaps are identified as generic data requirements that have not been satisfied
with acceptable data. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient thiabendazole, EPA has sufficient information on the human
health and ecological effects of thiabendazole to make decisions as part of the tolerance
reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The
Agency has determined that products containing thiabendazole are eligible for reregistration
provided that: (i) current data gaps and additional data needs are addressed; (ii) the risk
mitigation measures outlined in this document are adopted; and (iii) label amendments are made
to reflect these measures. Label changes are described in Section V.
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Based on its evaluation of thiabendazole, the Agency has determined that thiabendazole
and thiabendazole salt products, labeled and used as specified in this document, would not present
risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency may take regulatory action to
address the risk concerns from use of thiabendazole.
If all changes outlined in this document are incorporated into the labels, then all current
risks for thiabendazole will be mitigated. Certain uses of the chemical do not present risks of
concern; therefore, no label changes or amendments to the FIFRA registration are necessary at
this time.
If the Agency determines that any of the determinations described in this RED are no
longer appropriate, the Agency will pursue appropriate action, including but not limited to,
reconsideration of any portion of this RED.
B. Tolerance Reassessment
Based on the review of the generic data for thiabendazole, the Agency has sufficient
information to reassess tolerances for thiabendazole. Specific findings are discussed in the
following section. When making its reregi strati on decision, the Agency took into account all
comments received during the public comment period. These comments in their entirety are
available in the docket. A summary of the comments and the Agency response is noted in
Appendix J.
C. Regulatory Position
1. Food Quality Protection Act Findings
a.
'Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with thiabendazole.
EPA has determined that risk from exposure to thiabendazole is within its own "risk cup."
In reaching this determination EPA has considered the available information on the special
sensitivity of infants and children, as well as the chronic and acute food exposure. An aggregate
assessment was conducted for exposures through food, residential uses, and drinking water.
Results of this aggregate assessment indicate that the human health risks from these combined
exposures are considered to be within acceptable levels; that is, combined risks from all
exposures to thiabendazole "fit" within the individual risk cup. Therefore, the thiabendazole
tolerances remain in effect and unchanged.
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b. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for thiabendazole, with amendments
and changes as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no
harm for the general population. In reaching this determination, EPA has considered all available
information on the toxicity, use practices, and scenarios, and the environmental behavior of
thiabendazole. The only residential exposure to thiabendazole would be through the use of
thiabendazole treated paints and carpets. There are no other possible homeowner uses.
Therefore, EPA has considered only acute, chronic (non-cancer), and chronic (cancer) exposures
for dietary (food and drinking water) and short-term and intermediate non-occupational exposure
in its aggregate risk.
Aggregate Dietary Risks: Acute and Chronic: Acute and chronic non-cancer dietary risks (food
and water) are not of concern for any population subgroup, and no additional mitigation is
necessary.
Short-term and Intermediate-term Aggregate Risks: Short-term and intermediate-term risks
include exposure to food, water and short-term and intermediate-term non occupational risks.
The two short-term and intermediate-term risks identified are not of concern to the Agency, and
no mitigation is necessary.
c. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for thiabendazole, with amendments
and changes as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no
harm for infants and children. The safety determination for infants and children considers the
factors noted above for the general population, but also takes into account the possibility of
increased dietary exposure due to the specific consumption patterns of infants and children, as
well as the possibility of increased susceptibility to the toxic effects of thiabendazole residues in
this population subgroup.
The FQPA Safety Factor was reduced to IX based on the following factors: first, the
toxicity database includes an acceptable two-generation reproduction study in rats and acceptable
prenatal developmental toxicity studies in rats and rabbits. These studies show no increased
sensitivity to fetuses as compared to maternal animals following acute in utero exposure in the
developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in
a multi-generation reproduction study in rats. There was no evidence of abnormalities in the
development of the fetal nervous system in the pre/post natal studies. Adequate actual data,
surrogate data, and/or modeling outputs are available to satisfactorily assess dietary and
residential exposure and to provide a screening level drinking water exposure assessment.
Second, the Agency believes that its exposure assessments will not underestimate the potential
risk for infants and children from thiabendazole. Therefore, the additional 10X factor as required
by FQPA was reduced to IX.
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d. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program
to determine whether certain substances (including all pesticide active and other ingredients)
"may have an effect in humans that is similar to an effect produced by a naturally occurring
estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was scientific basis for including, as pan of the program,
the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA
also adopted EDSTAC's recommendation that EPA include evaluations of potential effects in
wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effects in humans, FFDCA authority to requrie the
wildlife evaluations. As the science develops and resources allows, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP
have been developed, thiabendazole may be subject to additional screening and/or testing to
better characterize effects related to endocrine disruption.
e.
Cumulative Risks
The Food Quality Protection Act requires that, when considering whether to establish,
modify, or revoke a tolerance, the Agency consider "available information" concerning the
cumulative effects of a particular pesticide's resides and "other substances that have a common'
mechanism of toxicity." The Agency is examining whether and to what extent benzimidazole
fungi cidal pesticides share a common mechanism of toxicity. Current information on the
common mechanism of toxicity for benzimidazole fungicides is limited, and the Agency's
understanding of this relationship needs to be further developed. As a result, the Agency has not
determined if it would be appropriate to include them in a cumulative risk assessment with other
benzimidazole fungicides or carcinogenic chemicals. Therefore, for the purposes of this risk
assessment, the Agency has assumed that thiabendazole does not share a common mechanism of
toxicity with other benzimidazole or carcinogenic chemicals.
D. Tolerances Summary
In the assessment, tolerances for residues of thiabendazole in/on plant commodities and
mushrooms [40 CFR §180.242 (a)] are presently expressed as the combined residues of
thiabendazole and 5-hydroxy-thiabendazole in animal commodities [40 CFR § 180.242 (b)J. For
purposes of tolerance enforcement, thiabendazole residues of concern have been determined to
include thiabendazole and its metabolite bendizmidazole (free and conjugated) in plant
commodities. For animal commodities, thiabendazole, 5-hydroxy-thiabendazole (tree and
conjugated), and benzimidazole have been determined to be the residues of concern in animals.
Accordingly, the tolerance definition for thiabendazole residues listed under 40 CFR 180/242 (a)
will be amended to read as follows:
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Tolerances are established for the combined residues of thiabendazole [2-(4-thiazolyl)
bendimidazole] and its metabolite benzimidazole (free and conjugated) in or on the
following raw agricultural commodities:
In addition, the tolerance definition for thiabendazole residues in animal commodjties listed under
40 CFR 180.242 (b) will be amended to read as follows:
Tolerances are established for the combined residues of thiabendazole [2-(4-thiazolyl)
benzimidazole] and its metabolite benzimidazole (free and conjugated) and benzimidazole
in or on the following raw agricultural commodities.
1. Tolerances Listed Under 40 CFR § 180.242(a)
Provided that the requested label amendments are made, sufficient data are available to
reassess tolerances for thiabendazole residues in/on apples, bananas, carrots, citrus fruits,
mushrooms, papayas, pears and potatoes. Additional data are required for cantaloupe, sweet
potato, wheat grain, wheat straw, soybean, and strawberry before the existing tolerances can be
reassessed.
Based on the current use patterns and the available residue data, the established tolerances
are adequate for thiabendazole residues in/on bananas, carrots, citrus fruits, mushrooms and
potatoes. However, additional storage stability data are required to support the sweet potato field
trial data. Available data indicate the established tolerance should be increased to 0.05 ppm on
sweet potatoes.
2. Tolerances Listed Under 40 CFR § 180.242(a) to be Revoked
The tolerances for thiabendazole residues in banana pulp should be revoked since banana
is not a regulated commodity. Tolerances should be revoked for thiabendazole residues in /on
sugar beet RACs and processed fractions, grapes, rice RACs and processed fractions, and hubbard
squash since uses on these crops are not being supported by the registrant, Syngenta. Tolerances
for residues in dried citrus pulp, potato processing waste, and wheat milled fractions should all be
revoked since thiabendazole residues do not concentrate in potato, wheat processed fractions,
dried citrus pulp in excess of the tolerance on whole citrus fruits. Under the New Tolerance
Section below, once a tolerance is established for residues in/on pome fruits, the separate
tolerances on apples and pears should be revoked.
3. Tolerances Listed Under 40 CFR § 180.242(b)
Sufficient data are available to reassess tolerances for thiabendazole residues in animal
commodities. Although benzimidazole, which is a residue of concern in animals, was not
determined in the feeding studies, data from the animal metabolism studies will be used to
calculate residue levels of benzimidazole in animal commodities for purposes of tolerance
reassessment and risk assessment. In addition, data from the ruminant feeding study were used to
reassess tolerances in hogs.
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The tolerances for meat of cattle, hogs, horses, goats, and sheep will be retained at 0.1
ppm to harmonize with Codex. Based on the aforementioned data, tolerances for thiabendazole
residues in meat by products of cattle, horses, goats, and sheep should be increased to 0.4 ppm
and that the tolerance for residues in hog, meat by products should be increased to 0.3 ppm. The
tolerance for thiabendazole residues in milk should be decreased to 0.1 ppm based on the data as
well.
4. Tolerances listed under 40 CFR § 180.242(b) to be Revoked
Based upon the maximum dietary burden for poultry (0.16 ppm) and data from the poultry
feeding study, tolerances for residues in poultry meat, meat by products, and eggs should be
revoked. In addition, based on the maximum dietary burden for beef cattle (37.6 ppm) and swine
(5.1 ppm) and the data from the ruminant feeding study, tolerances for residues in fat of cattle,
hogs, hoses, goats, and sheep should be revoked.
5. New Tolerances to Be Established under 40 CFR § 180.242 (a)
- New tolerances are needed for thiabendazole residues in/on wet apple pomace (12.0 ppm),
citrus oil (15.0 ppm), pome fruits (5.0 ppm based on group crop), and wheat forage and hay. At
the present time, sufficient data are only available to determine appropriate tolerances for residues
in wet apple pomace and citrus oil, Residue data are required before an appropriate tolerance can
be determined for residues in/ori wheat forage and hay. A summary of thiabendazole tolerance
reassessments is presented in Table 14.
Table 14. Tolerance Reassessment for Thiabendazole
Commodity
Current Tolerance,
ppm
Tolerance
Reassessment*, ppm
Comment/ [Correct Commodity
Definition]
Tolerances Listed Under 40 CFR § 180.242 (a)
Apples (post-h)
Avocados
Banana (pre&post-h)
Banana, pulp
Banana, pulp (post-h)
Beans, dry
Beets, sugar, pulp,
dehydrated
Beets, sugar, pulp, dried
10.0
10.0
3.0
0.4
0.4
0.1
3.5
3.5
Revoke
10
3.0
Revoke
0.1
Revoke
Revoke
Concomitant with establishing a 5.0 ppm
tolerance on Pome fruits, the tolerance on
apples should be revoked
Registrant is supporting avocado for
import only. Avocado
Banana
Banana pulp is not a regulated commodity
of ban ana.
Numerous SLNs registered.
Beans, dry
Technical Registrant is not supporting use.
Technical Registrant is not supporting use.
30
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Commodity
Beets, sugar, tops
Beet, sugar, without tops
Cantaloupes (post-h)
Carrots (post-h)
Citrus fruits (post-h)
Citrus, pulp, dried
(post-h)
Grapes
Lentils
Mangos
Mushrooms
Papayas (post-h)
Pears (post-h)
Potatoes (pre-&post-h)
Potatoes, processing waste
(pre-&post-h)
Rice, rough
Rice, straw
Rice, hulls
Soybeans
Squash, hubbard
Strawberries
Sweet potatoes (post-h to SP
intended only for use as
seed)
Wheat, grain
Current Tolerance,
ppm
10.0
0.25
15.0
10.0
10.0
- 35.0
10.0
0.1
10.0
40.0
5.0
10.0
10.0
30.0
3.0
10.0
8.0
0.1
1.0
5.0
0.02
1.0
Tolerance
Reassessment*, ppm
Revoke
Revoke
TBD
10.0
10.0
Revoke
Revoke
Revoke
10.0
TBD
5.0
Revoke
10.0
Revoke
Revoke
Revoke
Revoke
TBD
Revoke
TBD
0.05
TBD
Comment/ [Correct Commodity
Definition]
Registrant is supporting cantaloupe for
import only.
Carrot
Fruit, citrus, group
Data indicate that thiabendazole residues
do not concentrate in dried pulp in excess
of the 10 ppm tolerance established in/on
whole fruit.
No registered uses on grapes
Temporary tolerance expired 10/31/98
Registrant is supporting mango for import
only. Mangos
Mushroom
Registrant is supporting papaya for import
only. Papaya
Concomitant with establishing a 5.0 ppm
tolerance on Pome fruits, the tolerance on
pears should be revoked.
Potato
Data indicate that thiabendazole residues
do not concentrate in potato processed
commodities.
Technical Registrant is not supporting this
use.
Registrant is supporting seed treatment
only. Soybean, seed
No registered uses on squash.
Registrant is supporting strawberry for
import only. Strawberry
Residue data support a higher tolerance.
Sweet potato, roots
Residue data support a lower tolerance.
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Commodity
Wheat, straw
Wheat, milled fractions
(excluding flour)
Current Tolerance,
ppm
1.0
3.0
Tolerance
Reassessment*, ppm
TBD
Revoke
Comment/ [Correct Commodity
Definition]
Residue data support a lower tolerance
Data indicate that thiabendazole residues
do not concentrate in wheat processed
commodities
Tolerances listed under 40 CFR § 180.242 (b):
Cattle, meat
Cattle, fat
Cattle, meat byproduct
Milk
Hog, meat
Hog, fat
Hog, meat byproduct
Horse, meat
Horse, fat
Horse, meat byproduct
Goat, meat
Goat, fat
Goat, meat byproduct
Sheep, meat
Sheep, fat
Sheep, meat byproduct
0.1
0.1
• 0.1
0.4
0.1
0.1
0.1
0,1
0.1
0,1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Revoke
0.4
0.1
0.1
Revoke
0.3
0.1
Revoke
0.4
0.1
Revoke
0.4
0.1
Revoke
0.4
A category 40 CFR180.6(a)(3)' situation
exists for the potential of thiabendazole
resiudes in meat and fat of livestock.*
Residue data indicate that the tolerance
should be increased. Cattle, meat by
products
Tolerance should be lowered based on
data from ruminant feeding study
A category 40CFRl80.6(a)(3}' situation
exists for the potential of thiabendazole
residues in meat and fat of livestock
Residue data indicate that the tolerance
should be increased. Hog, meat
byproducts
A category 40 CFRl80.6(a)(3)' situation
exists for the potential of thiabendazole
residues in meat and fat of livestock.
Residue data indicate that the tolerance
should be increased. Horse, meat
byproducts
A category 40CFR1 80.6(a)(3}' situation
exists for the potential of thiabendazole
residues in meat and fat of livestock.*
Residue data indicate that the tolerance
should be increased. Goat, meat
byproducts.
A category 40 CFRl80.6(a)(3)' situation
exists for the potential of thiabendazole
residues in meat and fat of livestock.
Residue data indicate that the tolerance
should be increased. Sheep, meat
byproducts
32
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Commodity
Poultry, meat byproduct, and
meat
Eggs
Current Tolerance,
ppm
O.I
0.1
Tolerance
Reassessment1*, ppm
Revoke
Comment/ [Correct Commodity
Definition]
A category 40. CFR] 80.6(a)(3) situation
exists for the potential of thiabendazole
residues in poultry commodities.
Tolerances Needed Under 40 CFR § 180. 242 (a)
Apple, wet pomace
Citrus, oil
Fruit, pome, group
Wheat, forage and Wheat,
hay
None
None
None
None
12.0
15.0
5.0
TBD
Based on a 3.5x concentration factor for
wet apple pomace and HAFT residues of
3.4 ppm in/on apples
Based on an average 2.4x concentration
factor for citrus oil and HAFT residues of
5.2ppm in/on citrus fruits
Residue data support establishing a 5.0
ppm tolerance on pome fruits; the separate
tolerances on apples and pears should be
revoked
Data are required on thiabendazole
residues in/on wheat forage and hay.
* Tolerances in meat of cattle, goats, hogs, horses, and sheep are being retained to harmonize with Codex.
TBD To be determined
1 Based on animal metabolism studies (i.e. exaggerated feeding studies) these tolerances can be recommended for
revocation because they are no longer needed. When EPA establishes tolerances for residues in or on raw agricultural
commodities, consideration must be given to the possible residues of those pesticides in meat, milk, poultry, and/or
eggs produced by animals that are fed agricultural products containing pesticide residues.40CFRl 80.6(a)(3).
6.
Codex Harmonization
The Codex Alimentarius Commission has established maximum residue limits (MRLs) for
thiabendazole in/on various fruit, vegetable and animal commodities. Codex MRLs for
thiabendazole are currently expressed in terms of the parent for plant commodities and in terms of
the sum of parent and 5-hydroxy-thiabendazole for animal commodities. Once the tolerance
expressions for U.S. tolerances are modified to include residues of benzimidazole, the U.S.
tolerance definition will no longer be compatible with Codex. The following conclusions can be
made regarding efforts to harmonize the U.S. tolerances with the Codex MRLs:
(I) Once the U.S. tolerance definition is changed to include benzimidazole, the definitions of
the U.S. tolerances and Codex MRLs will be incompatible.
(II) The MRLs for banana, cereal grain, citrus fruits and milk are the only MRLs that are
numerically equivalent to the reassessed U.S. tolerances.
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7. Residue Analytical Methods
Adequate analytical methods are available for data collection and enforcing tolerances of
thiabendazole residues as currently defined. The Pesticide Analytical Manual (PAM) Vol. II
which lists several methods for determining residues of thiabendazole per se in or no plant
commodities and one method for determining residues of thiabendazole and 5-hydroxy-
thiabendazole in milk.
The registrant has proposed new HPLC/flouorometric detection methods for determining
residues of benzimidazole (free and conjugated) in/on plant commodities and residues of
thiabendazole, 5-hydroxy-thiabendazole (free and conjugated), and benzimidazole in animal
commodities. These methods are similar to the current enforcement methods. However, the new
methods employ additional clean-up procedures and utilize HPLC/fluorescence detection for
separating and quantifying residues.
E. Human Health Risk Mitigation
The following is a summary of the rationale for managing risks associated with the current
use of thiabendazole. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.
1. Dietary Risk Mitigation
a. Acute Dietary (Food)
The acute dietary risk for thiabendazole is below the Agency's level of concern for the
U.S. general population and all population subgroups, including infants and children at the 99.9th
percentile. The most highly exposed subgroup is children 1-6 years of age with 77% of the acute
Population Adjusted Dose (aPAD) occupied. The preliminary dietary risk assessment for
thiabendazole indicated that the acute dietary risk was above the Agency's level of concern for
children 1-6 years old (aPAD 117%). Mushroom overspray application was driving the risk.
Since that time, the registrant, Syngenta, has canceled the overspray mushroom application of
thiabendazole which has reduced the aPAD to 77%. Given this amendment, the acute dietary risk
is no longer of concern to the Agency, and no mitigation is necessary.
b. Chronic (Non-cancer) Dietary (Food)
Chronic (non-cancer) dietary risk is also not of concern. Chronic (non-cancer) dietary risk
for the most exposed population subgroups, all infants (<1 year) and children 1-6 years of age, is
2% of the chronic Population Adjusted Dose (cPAD). These risks are not of concern; therefore,
no mitigation measures are necessary to address chronic dietary risk from food.
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c. Chronic (cancer) Dietary
In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment, the Cancer
Assessment Review Committee has classified thiabendazole as "likely to be carcinogenic at doses
high enough to cause a disturbance of the thyroid hormonal balance. It is not likely to be
carcinogenic at doses lower than those which could cause a disturbance of this hormonal
balance." Thus, after carefully weighing expected exposure authorized under EPA label
requirements, current registered use patterns and allowed dietary exposure from imported crops
for thiabendazole are not likely to cause cancer. This classification was derived by the oral route.
An MOE approach was used and is supported by the weight-of-the-evidence that suggests that
thiabendazole may interfere with thyroid-pituitary homeostasis. The study evaluated was a 106-
week chronic toxicity/carcinogenicity study in Sprague-Dawley rats. Male rats had significant
increasing trends for thyroid follicular cell adenomas and combined adenomas/carcinomas, and
significant comparisons of the dose group and the control group (90mg/kg/day). There were also
significant differences in the pair-wise comparisons of the 30mg/kg/day) dose group for thyroid
follicular cell adenomas. In light of the systemic effects observed, dosing was considered
adequate for assessing the carcinogenic potential of thiabendazole in rats. The Cancer
Assessment Review Committee concluded that thiabendazole was carcinogenic in male and
female rats at high doses because treatment related increased incidence of thyroid follicular cell
adenomas was noted at high-dose male rats and mid-dose male rats, and high-dose female rats.
Thyroid tumors were considered to be treatment related due to the progressive nature of the tumor
and evidence of dose response. The weight-of-the-evidence indicates that thiabendazole may
interfere with thyroid-pituitary homeostasis at high doses. The Agency concluded that the thyroid
tumors in male and female rats were treatment related.
Thyroid cancer is a rare condition in the United States, occurring with an incidence of
about 4% per year of the population (based on 1997 statistics). The incidence is predominant in
older persons. In children it occurs at a rate of 1 per million. Therefore, it does not appear that
the young have a propensity for thyroid cancer. The basic elements of thyroid function and
hormone homeostasis are the same in children and adults. In the case of thiabendazole, the oral
perinatal and prenatal studies revealed no evidence of increased susceptibility of rat, rabbit or
mouse fetuses to in utero exposure. Therefore, based on the mode of action of thiabendazole,
children are not expected to be more susceptible than adults. The mode of action of
thiabendazole in animals, to the extent that it is applicable to humans, appears equally applicable
to human subpopulations. Therefore, children are not expected to be more susceptible to
thiabendazole-induced thyroid effects than adults. In conclusion, after careful examination of the
data, and expected exposure authorized under EPA label requirements and imported food, current
registered use patterns for thiabendazole are not likely to cause cancer.
d. Dietary (Drinking Water)
Model estimates (EECs) of potential drinking water exposure from ground water sources
do not exceed the acute or chronic (non-cancer and cancer) DWLOC values, and therefore, are
not of concern. Potential drinking water exposure does not exceed acute or chronic (non-cancer
35
-------
or cancer) DWLOC values, and is therefore not of concern to the Agency, No mitigation
measures are necessary to address drinking water dietary concerns.
2. Non-occupational Risk Mitigation
a. Non-occupational Non-cancer
The only non-occupational exposure expected to occur may include short-term application
of thiabendazole-treated paints by adults and exposure to thiabendazole-treated carpets by
children and infants. There are no exposure data for thiabendazole for these use patterns.
Therefore, the Agency used either surrogate data from the scientific literature, PHED and/or
modeling techniques for all of the exposure scenarios. Use information, for this reason, should be.
considered to be very conservative. For all exposure scenarios: it was assumed that all of the
thiabendazole on the treated surface could be transferred to the skin. The chemical is part of a
wax matrix and quantitative transfer to the skin is unlikely. In addition, with thiabendazole-
treated paints, the material is dispensed from either a hand-operated pump or in the form of a
pouch, and is mixed during formulation of the paint. The scenario is closed and is expected to
yield no appreciable post application exposures. The carpet exposure estimates were taken from a
spray study, and not a product that was treated during manufacture. MOEs for exposure to
thiabendazole-treated paints ranged from 290-560. The target MOE is 100 for all occupational
exposure scenarios. Since the MOEs (290-560) for exposure to thiabendazole-treated paints are
higher than the target MOE of 100 (an MOE of 100 or greater indicates a level in the acceptable
range for exposure) this risk is not of concern to the Agency, and no mitigation is necessary.
With carpet exposure, the MOEs range from 100-1000 for adults; 59-590 for toddlers; and 39-390
for infants. Since the exposure estimates were derived from a surrogate surface spray study
(thiabendazole is treated to the backs of carpets), and estimates assume that ALL residues on the
surface of the material are available for transfer; and because residues measured were surface
only, the Agency believes that use information should be considered extremely conservative.
Therefore, the Agency believes that the risks are an overestimation and no mitigation is
necessary.
b. Non-occupational Cancer
The Agency did not identify any non-occupational cancer risk scenarios and therefore, no
mitigation is necessary.
3. Aggregate Risk Mitigation
a. Acute Aggregate Risk
Estimated acute risk for thiabendazole for food is 77% of the aPAD for children 1 -6 years,
of age, and surface and ground water acute EECs are below the DWLOC for all population
subgroups. Thus, acute risk from food and water is not of concern and no mitigation is necessary.
36
-------
b. Short-term and Intermediate-term Aggregate Risk
Two short-term and intermediate-term exposure scenarios were identified for the adult
populations: exposure to thiabendazole-treated carpet and thiabendazole-treated paints. These
two scenarios were aggregated with the average dietary exposure since they can occur
simultaneously. Estimated average concentrations of thiabendazole in surface and ground water
are below the DWLOCs for thiabendazole in drinking water. Thus, short-term and intermediate-
term aggregate risk is not of concern and no mitigation is necessary.
c. Chronic (Non-cancer) Aggregate Risk
Chronic (non-cancer) aggregate risk for thiabendazole includes only food and water
exposures. Estimated risks from food for the most highly exposed subgroup, children 1-6 years
old, indicate that 2% of the cPAD is occupied by dietary (food) exposure and that surface and
ground water EECs are below the chronic DWLOC for this population subgroup. Therefore,
chronic (non-cancer) aggregate risks are not of concern, and no mitigation is necessary.
d. Chronic Cancer Aggregate Risk
In accordance with the Cancer Assessment Review Committee, the Margin of Exposure
(MOE) approach was used to assess cancer dietary risk. Use of PDF monitoring data, field trial
data, and calculated livestock anticipated residues (ARs) were used in the assessment. The results
of the chronic (cancer) dietary assessment indicate an MOE of 13,000 for the general U.S.
population, with the deletion of the mushroom overspray use. A MOE of 13,000 means that
potential exposures to humans is 13,000 times less than the exposure to rats at which no adverse
effects were observed. The MOE is based on the results observed in a rat study where
thiabendazole was shown to induce thyroid tumors in male rats and also based on mechanistic
studies showing disturbance of the thyroid-pituitary homeostasis. Rats have also demonstrated an
increased sensitivity compared to humans to thyroid induced tumors which adds an even greater
comfort level to the significance of the calculated MOE. Children are not expected to be more
susceptible to thiabendazole-induced thyroid effects than adults.
4. Occupational Risk Mitigation
a. Handler Exposure
There are potential occupational exposures to pesticide handlers via the dermal and
inhalation routes when applying thiabendazole. Scenarios assessed and corresponding risk
estimates are shown in Table 11. The footnotes indicate the level of protection (PPE) needed to
bring the risk estimate to a level that is not of concern (MOE greater than 100). Currently, for
thiabendazole, the labels state a restricted entry interval (REI) of 12 hours. The Agency does not
believe there is significant potential for post-application exposure to thiabendazole based on
application methods, timing and frequency. Therefore, the minimum Restricted Entry Interval
(REI) as established under EPA's Worker Protection Standards (WPS) for 12 hours, is sufficient
to protect workers who may re-enter treated areas.
37
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(1) Spray Application to Mushroom Houses
Spray application to mushroom houses is identified as an occupational use with MOEs
greater than 100. However, Syngenta has voluntarily canceled the overspray application of
thiabendazole on mushrooms as of October 10, 200J in order to mitigate dietary risks to children
1-6 years of age. Although this eliminated the acute dietary risk concern, there still exists an
occupational concern for the applicators. Therefore, the label language will be changed to specify
chemical resistant gloves be worn while applying thiabendazole to mushroom houses during
spawning only. No further mitigation is necessary.
(2) Manual Seed Treatment
Manual seed treatment has been identified as an occupational use with MOEs less than
100. However, manual seed treatment is virtually non-existent in current occupational operations.
The Agency believes that since this scenario is mostly non-existent, and has been replaced with
commercial seed treatment practices that it should be removed from the label. The label language
will be modified prohibiting manual seed treatment.
(3) Post-Harvest Sorter/Packers/Culling of Fruit
The Agency recalculated exposure numbers for workers sorting/packing/culling fruit after
harvest based on new transfer coefficiency information that was not available at the time of the
preliminary risk assessment. The new data provided an MOE of 1600, well above the Agency's
level of concern and therefore no additional risk mitigation is necessary for this scenario.
One occupational scenario was not assessed by the Agency due to lack of thiabendazole-specific
occupational data: Workers adding thiabendazole to paints and carpets. For large paint
operations, the addition of thiabendazole to paint is done by computerized mechanical equipment.
Occupational workers are only operating a computerized system and thiabendazole is added to the
paint in an assembly line fashion. No exposure is expected during this occupational scenario.
For small paint operations, thiabendazole is added to the paint from water soluble bags. The paint
is mixed in a kady mill mixer. Thiabendazole is added at the end of the mixing process. The
Agency has qualitatively considered whether exposure is likely and attempted to describe the
level of risk from this scenario. Based on the Agency's understanding of the smaller operations,
workers are instructed to wear rubber aprons, gloves, goggles and a face shield. Given the low
toxicity of thiabendazole, and the small amounts used in paints, the Agency does not have a risk
concern for workers adding thiabendazole to paints when the aforementioned personal protective
equipment is used.
5. Environmental Risk Mitigation
Given that the currently registered use patterns (i.e. post-harvest uses and seed treatment)
result in low exposures and the relatively low toxicity of thiabendazole, no environmental
mitigation is necessary.
38
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F.
Other Label Statements
In order to remain eligible for reregistration, other use and safety information need to be
placed on the labeling of all end-use products containing thiabendazole. For the specific labeling
statements, refer to Section V of this document
1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that will eliminate the adverse impacts. At present, the program
is being implemented on an interim basis as described in a Federal Register notice (54 FR 27984-
28008, July 3, 1989), and is providing information to pesticide users to help them protect these
species on a voluntary basis. As currently planned, but subject to change as the final program is
developed, the final program will call for label modifications referring to required limitations on
pesticide uses, typically as depicted in county-specific bulletins or by other site-specific
mechanisms as specified by state partners. A final program, which may be altered from the
interim program, will be described in a future Federal Register notice. The Agency is not
requiring label modifications at this time through the RED. Rather, any requirements for product
use modifications will occur in the future under the Endangered Species Protection Program.
V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section FV and V, which include, among other things, submission of the
following:
A. For thiabendazole technical grade active ingredient products, registrants need to
submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
39
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Please contact John W. Pates, Jr. at (703) 308-8195 with questions regarding generic
reregi strati on and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
By US mail: Bv express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
John W. Pates, Jr. John W, Pates, Jr.
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient thiabendazole. registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined in
Table 15 of this document;
(4) a completed form certifying compliance with data compensation
requirements (EPA Form 8570-31);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI,
Please contact Moana Appleyard at (703) 308-8175 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
40
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By US mail:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service onlv:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of thiabendazole for the above eligible
uses has been reviewed and determined to be substantially complete. The following data gaps
remain:
(1) In vitro mammalian gene mutation(870.5300)
(2) In vitro chromosome aberration assay (870.5375)
(3) Chemical Identity: Revised CSF (830.1550)
(4) UV/visible absorption (GLN 830.7050)
(5) Multiresidue method testing (GLN 860.1360)
(6) Additional storage stability data for sweet potatoes (GLN 860.1380)
(7) Additional residue data for benzimidazole (free and conjugated in/on cantaloupe
and strawberry for foliar application. (GLN 860.1500)
(8) Residue data on wheat, dry beans (if registrant intends to support), and soybeans
(GLN 860.1500)
(9) Processing study for the processed fractions of soybeans (GLN 860.1520)
A draft copy of the generic data call-in (DCI), outlining specific data requirements,
accompanies this RED.
2. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
MP labeling should bear the labeling contained in Table 15 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
41
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not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study master record identification (MRJD) numbers should be
cited according to the instructions in the requirement status and registrants response form
provided for each product.
A draft copy of the product-specific data call-in (PDCI), outlining specific data
requirements, accompanies this RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 15 at the end
of this section.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this RED. Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on the number
of products involved, the number of label changes, and other factors. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrant may distribute and sell thiabendazole products
bearing old labels/labeling for 12 months from the date of issuance of this RED. Persons other
than the registrant may distribute or sell such products for 24 months from the date of the
issuance of this RED, Registrants and persons other than the registrant remain obligated to meet
pre-existing label requirements and existing stocks requirements applicable to products they sell
or distribute.
D. Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table describes how language on the
labels should be amended.
42
-------
Table 15: Summary of Labeling Changes for Thiabendazole
Description
Amended Labeling Language
Placement on Label
Manufacturing-use Products
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by'a
formuiator or user group
'Only for formulation into fungicides for the following use{s) [fill blank only with those uses that are
seing supported by MP registrant]."
'This product may be used to formulate products for specific use(s) not listed on the MP label if the
formuiator, user group, or grower has complied with U.S. EPA submission requirements regarding support
of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label if the
formuiator, user group, or grower has complied with U.S. EPA submission requirements regarding support
of such use(s).".
Directions for Use
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries oceans or other
waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not
Precautionary Statements
under the subheading
Environmental HazardsEnd-
PPE Requirements
Established by the RED'
(All Formulations)
'Personal Protective Equipment (PPE)
'Mixers, loaders, applicators, and other handlers must wear:
* long sleeve shirt and long pants
* shoes, plus socks"
"In addition to the above, handlers making applications to mushroom houses using hand held sprayers
must wear chemical resistant gloves." (The glove statement is only required for
products labeled for use on mushrooms)
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
User Safety Requirements
(For All Products)
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
43
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Description
Amended Labeling Language
Placement on Laltel
Manufacturing-use Products
User Safety
Recommendations
Environmental Hazards
Restricted Entry Interval
( For products which include
use on mushrooms)
Early Re-entry PPE
Established by the RED.
(For products which include
use on mushrooms)
General Application
Restrictions
Other Risk Mitigation
Restrictions
"Users should wash hands before eafing, drinking, chewing gum, tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticides get inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after handling this product. As soon as possible, wash thoroughly
and change into clean clothing."
"Do not apply directly to water. Do not contaminate water by cleaning of equipment or disposal of waste."
"Do not enter or allow worker entry in(o treated areas during the restricted entry interval (REI) of 1 2
hours."
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
* coveralls,
* shoes plus socks
* chemical -resistant gloves made of any waterproof material."
"Do not apply this product in a way that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application."
Remove all manual seed treatment uses, and include the following statement:
" Manual seed treatments are prohibited."
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
Precautionary Statements
under Environmental Hazards
Directions for Use,
Agricultural Use
Requirements Box
Place in the Directions for
Use directly above the
Agricultural Use Box.
Directions for Use
1 PPE that is established on the basis of acute toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE
must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label.
Instructions in the Labeling section not in quotes represent actions that the Registrant should take to amend their labels or product
registrations.
44
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VI. Related Documents and How to Access Them
This Reregistration Eligibility Decision document is supported by documents that are presently
maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson
Davis Highway, Arlington, VA. It is open Monday through Friday, excluding federal holidays, from
8:30 am to 4:00 pm.
The docket initially contained preliminary risk assessments and related documents as of August 1,
2001. Sixty days later the first public comment period closed. The EPA then considered comments,
revised the risk assessment, and added the formal "Response to Comments" document and the revised
risk assessment to the docket on July 30, 2001.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: http://www.epa.gov/pesticides/rereeisrration.
45
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46
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VII. APPENDICES
47
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Appendix A. Thiabendazole Table of Use Patterns Eligible for Registration
$to-
Application "type
Application Timing . ' t'
Application Equipment « .
Apples
Post-Harvest
Dip, Spray, Mist
Post-Harvest
Wax Spray
Post-Harvest
Wax Spray;
Spray
Post-Harvest
Spray, Floodwater
Post-Harvest
Spray, Flood, Wax, Drench
or Slurry
Post-Harvest
Spray, Dip
Post-Harvest
Mist, Drench, Spray
Pears
Post-Harvest
Dip, Spray, Mist
Post-Harvest
Spray
Post-Harvest
Mist, Drench, Spray
Formulation^
EBPAReg, *$!
&>j;:^
- ,. >'4ti
42.3%
[100-889]
.20%
[2792-36
.20%
[5202-17]
98.5%
[5202-23]
98.5%
[5202-26]
98.5%
[43410-7]
98.5%WP
[43410-33]
42.3%
[100-889]
98.5%
[5202-17]
98.5% WP
[43410-33]
j;:MaXimtiip Siqgls -
"iAppiytionRitfr \
•;> r
f^mSf^t*^ ' '"
16 fluid oz. per 100
gallons water
1 Gallon of coating per
10,000 Apples
1 Gallon of coating per
8,000 to 1 0,000 Ibs. of
fruit
One Unit per 82.5
gallons water
One Unit (594 grams)
per 53 Gallons water
couldn't read label
1 6 fluid oz. per 100
gallons water
1 Gallon of coating per
8,000 to 10,000 Ibs. of
fruit
Y-pf^HJlJwfo^S^
fij^^" "'"'^^M^^
' , ^i^^*"*§fe!i?Fji4
Subsequent dosing
allowed
One application per
crop
One application per
crop
One application per
crop
One application per
crop
One application per
crop
Subsequent dosing
allowed
One application per
crop
«vp ' « su
£• USeXiraitatipitejr
H^%*V^X
:^|^:/f^;;M-
k'l /*t>4-s< -v 0V V
WJJff^\t V4
-Treat apples only
before or after storage
-Do not contaminate
water food or feed by
storage or disposal
-Do not contaminate
water, food or feed by
storage or disposal
-Do not contaminate
water, food or feed by
storage or disposal
-Do not contaminate
water, food or feed by
storage or disposal
-Do not contaminate
water, food or feed by
storage or disposal
Treat pears only once
-Do not contaminate
water, food or feed by
storage or disposal
48
-------
,oV ••W'*-" •>
§ rf4i*V' ,fn
'^BS'^^
w^tag^«:
*;,, ,~ ^^f^^v ,J
Post-Harvest
Spray, Floodwater
Post-Harvest
Spray, Flood,
Drench or Slurry
» ,\f 1W$w£t*SJ««
ForisMatioii||||
98.5% WP
[5202-23]
98.5%
[5202-26]
"J Ktodt^fl&S^gK i
* , «.* ***. y- WW" !-! *• '
»* AonrtPanAh*K»tf* ^
"•W^-Pr***1*11™ ^**K*J-
,5 ^TV >" i- n
* i 4 /, , * J^T / -*
One Unit per 82.5
gallons water
One Unit (594 grams)
per 53 gallons of water
. -i~^, ,, * ^ „» ^
'iMpimtHipftwjlb^
^to^ji^t£«^^
One application per
crop
One application per
crop
- ^1,-s- •§ f ™ V
iAW58*tt»w*¥'
-Do not contaminate
water, food, feed by
storage or disposal
Citrus • - - '"' '•'-"-:' "' '
Post-Harvest
Dip
Post-Harvest
Spray
Post-Harvest
Spray, Flood,
Post-Harvest
Spray, Flood
Post-Harvest
Spray, Flood, Drench
Slurry
Post-Harvest
Spray
Post-Harvest
Spray-brush Applicator
Post-Harvest
Dip, Spray
.10%
[2792-35]
98.5% WP
[2792-50]
98.5% WP
[5202-23]
98.5% EC
[5202-24]
98.5% FC
[5202-26]
5.0% SC
[8764-12]
.1%RTU
[8764-40]
98.5% SC
[8764-50
1 Gallon per 8 Ibs.
citrus
577 grams (1 bag) per
55 gallons of ready-to-
use wax formulation
One unit per 82.5
gallons of water
One unit per 55 gallons
of wax
One unit (594 grams)
per
53 gallons of water
One gallons per 250
gallons
of water
One gallon per 10,000
obs. of
fruit
15.2 oz. per 580
Gallons of
water
One application
One application
One application
One application
One application
One application
One application
-Do not contaminate
food, feed by storage
or disposal
49
-------
Sifc;-^ *'£ ' ' , -
^RMon^' ,%;•-,
MptatmTNng' *?v """
">£ i' "S P.' * %<.*•<, AC
^$tyttiQ9^|anenri> t* ^
Post-Harvest
Spray, Dip
Post-Harvest
Mist, Drench, Spray
* *£ * j, J fv
wtfbaSttiqbjtf
«^*i*««fS£ ^ ' f.-v »
PMJRB^«
Nctlfr1^^^^
98.5% WP
[43410-7]
98.5% WP
[43410-33]
i**1* '
^rMkdmipn$iiiglft
^A^^thm J^ter ^
? l I -i '
i t
tfcci^avS«ro^i
$$$W$tifal'&
»& fw.-*"5 * tiffi j Zf&^^f.f
j^ypCLiraitaiiqns
A'1 ~3 Jjt, f &&>$£$'
-^
-------
3. ", ! f f t r t_ ' f
Sitef>> *" , v«£^,
AOTHcatfojvType £ ^K^
^r = J- vr *s, j*,~j^..^
i%j>If6rii0flTiii»ing°4 •fflj*^
^plicaa^Eq^m^T^
\ a ^ J, , ' , J.
pdaaUtaMffu^
ElA Jf, fr- jtfff
FfflwjR^b:??^
I^^J'V^StST*^
VJftfSf1, '***,?&
^"dk °, •< 'V
j^C *vt£s
t,?"1'?*''1 -*t$f4l*
-Ji^V ^x<.
lf M&slmum Srode *•
|:^pUos^rfi^e /f
&•?• "'^'^v ^^1Jt ^ t , ~* ^ s*
.IM VY * '^V-^fj a l
*i TS» Sr*ir^^., =
^ ^ -T* ^ T"&£ ii -v*"1
%••*»' ?Cv 'i, i>->v|^5 /
j, +^1 ^ p-. ^ *,^ i*
«= ^ * ' r1
• &3TO>HirJR$$Je^ \
Y&4a$&^
A v *rT ' ~**£l -» s
•V^y -%t^>T*
^^ifrWfy^
J^st '*vy^?>^ ;
^ \** I
a Jpe limitations ^
T f« i ^ c j-* *1 ?* \ r ^/
^;^/^P-/V
9M^?:y
r^ vV ^f' "N i
Potatoes
Tubers
Post-Harvest
Mist, Dip, Spray
Post-Harvest
Mist, Drench, Spray
Post-Harvest
Mist
42.3% FC
[100-889]
9&.5% WP
[43410-33]
98.5% WP
[2792-50]
0.42 Fluid oz. per
gallon of water per
2,000 tubers
5.67 grams/2000 tubers
in sufficient water
Subsequent dosing
allowed
-Do not treat potatoes
after cutting
Potato and Sweet Potato Seed Pieces . ,
Pre-Harvest
Dip, Spray, Mist
Pre-Harvest
Dust
Pre-Harvest
Spray, Dip
42.3% FC
[100-889]
.5% D
[2935-417]
98.5%
[43410-7]
8 Fluid oz. per 7. 5
gallons of water
1 Ib. ofdusttolOOlbs
of cut potato seed
pieces
One application
One application
-Do not use treated
roots for food or feed
-Do not apply to
water or to areas
where surface water is
present
Seed Soybean, Wheat
Spray mist or Slurry
Slurry Seed Treatment by
machine
Slurry treatment by
machine
Ready-To-Use
30% FC
[100-890]
2.5% RTU
[400-438]
2.7% FC
[400-439]
.54% FC
[2935-497]
2.0 - 4.0 Fluid 02. per
equal amounts of water
per bushel
3 Fluid oz. per iOOlbs.
of seed
2.5 - 4.0 Fluid oz. per
IOOlbs of seed
3 Fluid oz. per bushel
One application
One application
One application
One application
-Do not use for food,
feed or oil purposes
51
-------
Slurry Treatment
1.0% FC
[7501-131]
4Fluidoz.perl001bs.
seed
One application
Ready Mix or Slurry
Treatment
30% FC
[7501-134]
4 Fluid oz. per equal
amounts of water
One application
Slurry Treatment, Mist
.34% RTU
[7501-135]
6.6 Fluid oz. per bushel
One application
Slurry Treatment, Mist
1.5%FC
[7501-166]
5 Fluid oz. perlOOlbs.
seed
One application
Ornamental Bulbs and Corms
Post-Harvest
Dip, Spray, Mist
42.3% FC
[100-889]
30 Fluid oz. per 100
gallons of water
One application
Paint, (Interior and Exterior), Wallpaper, Adhesives, Nylon Carpeting, Textiles
Conventional Blending
Methods
98.5% WP
[43410-33]
Conventional Blending
50% RTU
[47332-7]
One Syringe per one
gallon paint
Conventional Blending
50% SC
[62366-1]
10 grams (1 pouch) to 1
gallon of paint or
adhesive
52
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration
Decision
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within the Case 2670 covered by this RED. It contains generic data requirements that apply
to thiabendazole in all products, including data requirements for which a "typical fonnulation" is the test
substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. the reference numbers accompanying each test refer to the
test protocols set in the Pesticide Assessment Guidance, which are available from the
National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161
(703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MIRD) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
53
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
Thi abend azole
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
New Guideline
Number
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.7000
830.7050
830.7200
830.7300
830.7840
830.7860
830.7950
830.7370
Old Guideline
lumber
61-1
6 1-2 A
61-2B
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-12
None
63-5
63-7
63-8
63-9
63-10
Chemical Identity and
Composition
Stan. Mat. & Mnfg. Process
Description of Production Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated
temperatures, metals, and ions
pH of Water Solutions
UV/Visable Light
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
Data Gap, 00029108,
00047895, 00047980, 00051865,
00125601, 40835501, 41258204,
44724601
00029108, 00047895, 00047980,
00051865,00125601,40835501,
41258204
00029108, 00047895, 00047980,
00051865, 00125601,40835501,
41258204
00029108, 00047895, 00047980,
00051865, 00125601, 40835501,
41258204-
41083501, 41473301, 44724602
41083501,41473301
41083501
40789801
40789801
40789801
41025001,43172801
40789801
Data Gap
40789801
40789801
40947301
40789801
40947302
54
-------
Data Supporting Guideline Requirements for the
Thiabendazole
Reregistration of
REQUIREMENT
830.7550
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.1075
850.1075
850.1010
63-11
Octanol/Water Partition
Coefficient
USE PATTERN
ABCKMO
CITATION(S)
40789801
ECOLOGICAL EFFECTS
71-1
71-2A
71-2B
71-3
71 -4A
71-4B
72-1 A
72- 1C
72-2A
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ABCKMO
ABCKMO
ABCK
ABCK
ABCK
ABCK
ABCK
ABCKMO
ABCKMO
41025002,232421
41025003,232421
41025004
41258201, 100853
235974
235974
42477701,41025006,227331,
42508901
41025005,227331,
41709401,232421
TOXICOLOGY
870.1100
870.1200
870.2400
870.2500
870.2600
870.3100
870.5300
870.5375
81-1
81-2
81-4
81-5
81-6
82-1A
84-2
84-2B
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
41258201
41258202
40789806
40789807
40271701
42942801,42942802
Data Gap
Data Gap
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.1240
835.6100
161-1
161-2
161-3
162-1
162-2
162-3
163-1
164-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
ABCK
ABC
ABC
ABCK
ABC
ABC
ABCK
ABCK
41265301
43328305
41397301,41397302
41791201
41559601
41559601
41170102
43187201,43187202,43187203
55
-------
Data Supporting Guideline Requirements for the Registration of
Thiabendazole
REQUIREMENT
USE PATTERN
CITATION(S)
RESIDUE CHEMISTRY
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
860,1480
171-4A
171-4B
171-4C
171-4C
171-4M
171-4E
171-4J
860.1500 171-4K
860.1500 171-4K
Nature of the Residue - Plants
Nature of the Residue - Livestock
Residue Analytical Methods -
Plant
Residue Analytical Methods -
Animals
Multi residue Method
Storage Stability
Magnitude of Residues in Meat,
Milk, Poultry and Eggs
Meat, Meat-by-products, and fat of
cattle, goats, hogs, horses, and
sheep
Milk
Meat and Meat-by-products of
poultry
Eggs
Crop Field Trials
Cantaloupe
Strawberry
Wheat
Dry Beans
Soybeans
Crop Field Trials
Carrots
Potato
Sweet Potato
ABK
AB
ABK
ABK
ABCK
ABK
AB
ABK
ABK
41872901, 41872902, 41872903
42011701,42057901
42718401, 43328301, 43328302,
4332803, 43328307, 43547601,
43721902, 43721903, 43721904
00123329, 40271706, 40271707,
40789815,40789817,40789818,
43251501, 43251503, 43251504
Data Gap
Data Gap, 40271706,
40271707, 40789816, 40789817,
40789818, 42515802, 42568001,
42718401, 42868701, 43251502,
43251 505, 43531 001, 43547601
40789817
40789817
00123329
00123329
Data Gap
00123302,00123303
^2660302, 4353 1002, 43547601
42660301,43531002,43547601
56
-------
Data Supporting Guideline Requirements for the Reregistration of
Thiabendazole
REQUIREMENT
860.1520
860.1520
860.1850
171-4L
I71-4L
165-1
Citrus Fruits Group
Apples
Pears
Wheat, grain
Wheat, straw
Bananas
Mushrooms
Papayas
Tobacco
Processed Food/Feed
Soybeans
Apple
Processed Food/Feed
Citrus, dried pulp
Potato, processing waste
Wheat, milled fractions (Flour)
Confined Rotational Crop
USE PATTERN
AB
AB
AB
CITATION(S)
42568001, 43328306, 43328307,
43721904
42515802,43721903
42515801,43721903
42718401,43328301,43328302
42718401,43328301,43328302
42868701,43721901,43721902
42598901,43531001
00071747, 00071748, 00071749,
00071750, 00123334, 00123335
42905201
Data Gap
42515802,43721903
42568001,43328306
42660302,43531002
42718401
43 1 8720 1,431 87202, 43 1 87203,
42367801
57
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room 119, Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, VA. It is open
Monday through Friday, excluding Federal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
August 1, 2001. Sixty days later the first public comment period closed. The EPA then
considered comments, revised the risk assessment, and added the formal "Response to
Comments" document and the revised risk assessment to the docket on October 1, 2001.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
www.epa.gov/pesticides/op
These documents include:
HED Documents:
1. Shallal, Suhair (USEPA/OPPTS/HED) Memo to Beth Edwards of SRRD
on the thiabendazole Responses to Registrant's Error Corrections and
Comments. August 8, 2000.
2. Shallal, Suhair (USEPA/OPPTS/HED) Memo to Beth Edwards of SRRD
on Thiabendazole and Thiabendazole Salt, HED Risk Assessment for the
Reregi strati on Eligibility Decision (RED) Document. May 1, 2000.
3. Jaquith, David (USEPA/OPPTS/HED) Memo to Suhair Shallal on the
Occupational and Residential Exposure Assessment and
Recommendations for the Reregi strati on Eligibility Decision (RED) for
Thiabendazole. March 14, 2000.
4. Diwan, Sanjivani (USEPA/OPPTS/HED) Memo to David Nixon of HED
on the Thiabendazole Report of the Cancer Assessment Review
Committee. February 24, 2000.
5. Shallal, Suhair (USEPA/OPPTS/HED) Memo to Beth Edwards of SRRD
on the Revised HED Risk Assessment for the Reregistration Eligibility
Decision (RED) Document. September 28, 2000.
6. Morton, Thurston (USEPA/OPPTS/HED) Memo to Suhair Shallal of HED
on Thiabendazole. Revised Acute and Chronic (Non-cancer and Cancer)
Dietary Exposure and Risk Analyses for the HED Human Health Risk
Assessment. September?,2000.
58
-------
7. Morton, Thurston (USEPA/OPPTS/OPP/HED) Memo to Suhair Shallal of
HED on the Thiabendazole Revised Acute and Chronic (Non-cancer and
Cancer) dietary Exposure and Risk Analyses for the HED Human Health
Risk Assessment. December 8, 1999.
8, Morton, Thurston (USEPA/OPPTS/OPP/HED) Memo to William Sproat
of SRRD on Thiabendazole. Product and Residue Chemistry Chapters for
the Thiabendazole Reregistration Eligibility Decision (RED). December
8,1999.
9. Nixon, David (USEPA/OPPTS/OPP/HED) Memo to Suhair Shallal of
HED on Thiabendazole. The HED Toxicology Chapter for the
Reregistration Eligibility Decision Document (RED). October 12, 1999,
10. Morton, Thurston (USEPA/OPPTS/OPP/HED) Memo to Beth
Edwards/William Sproat on Thiabendazole. Anticipated Residue
Assessment for the HED Risk Assessment. October 7, 1999.
11. Guant, Patricia (USEPA/OPPTS/OPP/HED) Memo to Suhair Shallal of
HED on Thiabendazole-Report of the Hazard Identification Assessment
Review. July 21, 1999.
12. Shallal, Suhair (USEPA/OPPTS/OPP/HED) Memo to Lorilyn Montford.
A Revised HED Risk Assessment for the Reregistration Eligibility
Decision (RED) Document. June 21,2001.
13. Hummel, Sue (USEPA/OPPTS/OPP/HED) Memo to Beth Edwards.
Thiabendazole: Product and Residue Chemistry Chapters for the
Thiabendazole R.E.D. December 8, 1999.
EFED Documents:
1. Nguyen, Thuy (USEPA/OPPTS/OPP/EFED) Memo to Beth Edwards of
SRRD on EFED Reregistration Eligibility Document for Thiabendazole.
February4, 1999.
Other Related Documents:
1. Montford, Lorilyn (USEPA/OPPTS/OPP/SRRD) Overview of Revised
Risk Assessment for the Reregistration Eligibility Decision for
Thiabendazole. July 16, 2001.
2. Montford, Lorilyn (USEPA/OPPTS/OPP/SRRD) Summary of Revised
Risk Assessment for the Reregistration Eligibility Decision for
Thiabendazole. July 16, 2001
59
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations' of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included,
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identity volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs,
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
60
-------
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the,bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
61
-------
BIBLIOGRAPHY
MR1D CITATION
00029108 Merck & Company, Incorporated. Basic Manufacturing Process for Formulation
Mertect 340-F. (Unpublished study received Aug 1, 1978 under 618-75;
CDL:099237-B)
00047895 Merck & Company, Incorporated, The Identity, Physical and Chemical
Properties of Thiabendazole. (Unpublished study received Aug 7, 1974 under
5F1537;CDL:094556-B)
00047980 Merck & Company, Incorporated Confidential Formula: [Thiabendazole],
(Unpublished study received May 15, 1968 under 8F0724; CDL:093034-C)
00051865 Merck & Company, Incorporated (1970) The Identity, Physical and received Jun
21, 1974 under 4F1518; CDL:094030-B)
00071747 Interregional Research Project Number 4. Residues of Thiabendazole of Papaya
following Postharvest Treatment. (Unpublished study received Jan 26, 1981
under 9E2263; CDL:099886-A)
00071748 Interregional Research Project Number 4 (1980) Residue Data: Papaya:
Thiabendazole. (Compilation; unpublished study received Jan 26, 1981 under
9E2263; CDL:099886-B)
00071749 Merck & Company, Incorporated (1969) Thiabendazole Determination in Apples.
Method dated Nov 4, 1969. (Unpublished study received Jan 26, 1981 under
9E2263; submitted by Interregional Research Project No. 4, New Brunswick,
N.J.; CDL:099886-C)
00071750 Interregional Research Project Number 4. Thiabendazole. Undated method.
(Unpublished study received Jan 26, 1981 under 9E2263; CDL:099886-D)
00123299 Interregional Research Project No. 4. Analytical Method: [Thiabendazole]. '
(Compilation; unpublished study received Mar 23, 1971 under 1E1151;
CDL:093467-A)
00123302 Interregional Research Project No. 4 (1979) The Results of Tests on the Amount
of Thiabendazole Residues Remaining in or on Carrots Including a Description of
the Analytical Method. (Unpublished study received Nov 8, 1979 under OE2292;
CDL:099085-A)
62
-------
BIBLIOGRAPHY
MRID
CITATION
00123303 Interregional Research Project No. 4 (1979) Mertect 340 F: Mold Control in
Carrots. (Compilation; unpublished study received Nov 8,1979 under OE2292;
CDL:099085-B)
00123329 Downing, G.; Olson, G.; Campbell, M; et al. (1979) Residue Assay Method and
Residue Study for Thiabendazole in Chicken Tissues and Eggs. (Unpublished
study received May 17, 1979 under 618-75; submitted by Merck & Co., Inc.,
Rahway, NJ; CDL:2385I7-A)
00123334 Interregional Research Project No. 4 (1979) The Results of Tests on the Amount
of Thiabendazole Residues Remaining in or on Papayas Including a Description
of the Analytical Method Used: (Compilation; unpublished study received Sep 5,
1979 under 9E2263; CDL:240973-A)
00123335 Interregional Research Project No. 4 (1978) [Efficacy: Thiabendazole].
(Compilation; unpublished study received Sep 5, 1979under 9E2263;
CDL:240973-B)
00125601 Merck & Co., Inc. (1968) The Name, Chemical Identity, and Composition of the
Pesticide Chemical: [Thiabendazole]. (Compilation; unpublished study received
Aug28, 1970 under 1F1031; CDL:093340-B)
100853 The Woodard Research Corporation. (1981) Toxicity Study of Thiabendazole in
Rats and Dogs over a two year period,
227331 Merck, Sharpe and Dohme Research Laboratories., Rahway, NJ R.R. Buck,
December 16, 1976. Two Applications for Registration Covering the Use of
Thiabendazole Products to Treat Dutch Elm Disease.
232421 Merck, Sharp and Dohme Research Laboratories, Rahway, NJ. R.R. Buck,
November 30, 1977. Completion of Eight Studies Conducted in Support of
Arbotect. EPA Registration No. 618-89.
235974 Wildlife International Ltd. October 31, 1978, Project No. 105-120. One
Generation Reproduction Study on Bobwhite Quail, Final Report. Sponsored by
Merck and Company, Inc.
40271701 Blaszcak, D. (1986) Thiabendazole: A Closed-patch Repeated Insult Dermal
Sensitization Study in Guinea Pigs (Modified Buehler Method): Lab Project No.:
6457-86. Unpublished study prepared by Bio/Dynamics, Inc. 18 p.
63
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BIBLIOGRAPHY
MRID
CITATION
40271706 Justin, J. (1987) Thiabendazole Determination in/on Corn By-products from
Treated Corn and Sensory/Palatability Study: Lab Project ID: ME 340-1.
Unpublished study prepared by Merck & Co., Inc. 99 p.
40271707 Predmore, L.; Justin, J. (1987) Feeding Study in Lactating Cows with
Thiabendazole: Lab Project ID: 35253. Unpublished study prepared by Merck &
Co., Inc. in cooperation with ABC Laboratories, Inc. 193 p.
40789801 Justin, J. (1988) Thiabendazole: Product Chemistry: Supplement to MRID No.
47895: Project ID. PC-MRK-3. Unpublished study prepared by Merck & Co.,
£ Inc. 30 p.
40789806 Lankas, G. (1981) Thiabendazole Veterinary (Lot ERM-211): Primary Eye
Irriatation Study in Rabbits: Supplement to MRID 100705: Project ID. TT
#81-2693. Unpublished study prepared by Merck Sharp & Dohme Research
Laboratories. 15 p.
40789807 Lankas, G. (1981) Thiabendazole Veterinary (Lot ERM-211): Primary Dermal
Irriatation Study in Rabbits: Supplement to MRID No. 100705: Project ID. TT
#81-2692. Unpublished study prepared by Merck Sharp & Dohme Research
Laboratories. 11 p,
40789815 Justin, J. Residue Analytical Methods: Supplemental to MRID No's 40271706
and 40271707. Unpublished study. 8 p.
40789816 Justin, J. Storage Stability Data: Supplement to MRID 40271706 and 40271707.
Unpublished study, 7 p,
40789817 Predmore, L. (1987) Feeding Study in Lactating Cows with Thiabendazole:
Supplement to MRJD 40271707: Project ID. 35253. Unpublished study prepared
by ABC Laboratories, Inc. and Merck & Co. 9 p.
40789818 Downing, G.; Olsen, G.; Campbell, M. (1979) Residue Assay Method and
Residue Study for Thiabendazole in Chicken Tissues and Eggs: Supplement to
MRID 123329: Project ID. CDL 23817-A. Unpublished study prepared by Merck
&Co. 8 p.
40835501 Justin, J. (1988) Thiabendazole: Product Chemistry: Supplement to MRIDs Nos:
00047895; 00047980; 00051865; 00029108; 00125601: Project ID: PCTM 61.
Unpublished study prepared by Merck & Co,, Inc. 82p.
64
-------
BIBLIOGRAPHY
MRJD
CITATION
40947301 Rose, K.; Kauppila, K. (1988) Thiabendazole: Product Chemistry: Lab ID:
159-88-0144-AS-OOI. Unpublished study prepared by Ricerca, Inc. 72 p.
40947302 Book, D.; Thomas, E. (1988) Thiabendazole: Product Chemistry: Lab ID:
1959-88-0145-AS-001. Unpublished study prepared by Rkerca, Inc. 71 p.
41025001 Justin, J. (1989) Thiabendazole: Stability of 2,-(4-Thiazolyl Benzimidazole: Proj.
ID CHEM - 89. Unpublished study prepared by Merck & Co., Inc. 10 p.
41025002 Grimes, J.; Jaber, M, (1989) Technical Thiabendazole: An Acute Oral Toxicity
Study with the Bobwhite: Final Rept: Proj. No. 105-138. Unpublished study
prepared by Wildlife International Ltd. 26 p.
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.
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.
41083501 Justin, J. (1989) Thiabendazole: Analysis and Certification of Ingredient Limits:
Project ID: PC 622623. Unpublished study prepared by Merck & Co., Inc. 50 p.
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.
41258201 Lankas, G. (1981) Thiabendazole Veterinary (Lot ERM-211): Acute Oral
Toxicity Study in Rats: Project ID 81-2691. Unpublished study prepared by
Merck Sharp & Dohme Research Laboratories. 26 p.
65
-------
BIBLIOGRAPHY
MRID
CITATION
41258202 Blaszcak, D. (1989) Thiabendazole (Batch #Dr M6 17): Acute Dermal Toxicity
Study in Rabbits: Project ID 4004-86. Unpublished study prepared by
Bio/Dynamics, Inc. 16 p.
41258204 Justin, J. (1989) Thiabendazole - Chemical Identity: Amendment to MRID No.
40789814: Project ID DC 618. Unpublished study prepared by Merck & Co., Inc.
10 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.
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.
41473301 Justin, J. (1990) Thiabendazole: Additional Product Chemistry (Supplement to
MRID 41083501). Lab Project Number: PC 622623. Unpublished study. 9 p.
41559601 Daly, D.; Williams, M. (1990) Anaerobic Soil Metabolism of Carbon
14-Thiabendazole: ABC final Report 37640. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 1062 p.
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.
41791201 Daly, D.; Williams, M. (1991) Aerobic Soil Metabolism of Carbon
14-Thiabendazole: Final Rept: Lab Project Number: 37639. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 1876 p.
41872901 Halls, T.; Sanson, D. (1991) The Metabolic Fate of Thiabendazole (TBZ) in
Wheat: Final Report #3772 4: MC-8807. Unpublished study prepared by ABC
Laboratories, Inc. 314 p.
66
-------
BIBLIOGRAPHY
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CITATION
41872902 Halls, T.; Sanson, D. (1991) The Metabolic of Fate Thiabendazole (TBZ) in
Soybeans: Final Report #37725; MC-8807. Unpublished study prepared by ABC
Laboratories, Inc. 250 p.
41872903 Halls, T.; Sanson, D. (1991) The Metabolic Fate of Thiabendazole (TBZ) in
Sugar Beets: Final Report #37726; MC-8807. Unpublished study prepared by
ABC Laboratories, Inc. 206 p.
42011701 Halls, T.; Avor, K.; Sanson, D. (1991) Metabolism of [Carbon 14]-Thiabendazole
(TBZ) in Poultry: Lab Project Number: 37728. Unpublished study prepared by
ABC Labs Inc. 116p,
42057901 Halls, T.; Avor, K.; Sanson, D. (1991) Metabolism of Carbon 14-Thiabendazole
(TBZ) in Lactating Dairy Goats: Lab Project Number: 37729. Unpublished study
prepared by ABC Laboratories, Inc. 368 p.
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.
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.
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.
42515801 Norton, J.; Armstrong, T. (1992) Determination of the Magnitude of the Residues
of the Fungicide Thiabendazole in Pome Fruit (Pears) Treated with a Dip and
Wax Treatments: Lab Project Number: 93104; 001-90-3059R: 001-90-3060R.
Unpublished study prepared by Merck Research Labs. 532 p.
42515802 Norton, J.; Armstrong, T. (1992) Determination of the Magnitude of the Residues
of the Fungicide Thiabendazole in Pome Fruit (Apples) Treated with a Dip and
Wax Treatments: Lab Project Number: 93109: 001-90-3062R: SARS-90-WA-
39G. Unpublished study prepared by Merck Research Labs. 585 p.
42568001 Norton, J.; Armstrong, T. (1992) Determination of the Magnitude of the Residues
of the Fungicide Thiabendazole in Citrus Treated with a Dip and Wax Treatment:
67
-------
BIBLIOGRAPHY
MRID
CITATION
Lab Project Number: 93064: 001-90-3049R: SARS-90-CA-34, Unpublished
study prepared by Merck Research Labs. 1959 p.
42598901 Norton, J.; Nelson, R. (1992) Determination of the Presence and Magnitude of the
Residues of the Fungicide Thiabendazole in Mushrooms Treated with MERTECT
340-F in Irrigation Water and by Direct Application: Lab Project Number: 93041:
001-90-3043R. Unpublished study prepared by Merck Research Labs, and Plant
Services, Inc. 683 p.
42660301 Norton, J. (1993) The Determination of the Presence and Magnitude of Residues
of the Fungicide Thiabendazole in Sweet Potatoes Grown from Seed Roots
Treated with Mertect 340-F: Lab Project Number: 92851: 001-90-3037R: ASA-
90-NC01. Unpublished study prepared by Agricultural Systems Associates and
Merck Research Labs, 394 p.
42660302 Norton, J,; Armstrong, T. (1993) Determination of the Magnitude of the Residues
of the Fungicide Thiabendazole in Potatoes Treated with Mertect 340-F by Mist
Application: Lab Project Number: 93036: 001-90-3031R: SARS-90-ID-32.
Unpublished study prepared by Stewart Agricultural Research Services, Inc. and
Merck Research Labs. 658 p.
42718401 Norton, J.; Armstrong, T. (1993) Determination of the Magnitude of the Residues
of the Fungicide Thiabendazole in Wheat Treated with MERTECT DF: Lab
Project Number: 93020: 3020: 001-90-3000R. Unpublished study prepared by
Strewart Agricultural Research Services, Inc. in assistance with Merck Research
Lab. 1857 p.
42868701 Norton, J. (1993) Determination of the Magnitude of Residues of the Fungicide
Thiabendazole in Green and Ripened Banana Fruit Imported from Honduras: Lab
Project Number: 93768: 001-92-3010R: 001-92-3011R. Unpublished study
prepared by Merck Research Labs and Research Designed for Agriculture. 869 p.
42905201 Chukwudebe, A. (1993) Magnitude of Thiabendazole Related Residues in Freshly
Harvested Tobacco Leaves Following Applications of 14-C Thiabendazole to
Tobacco Seedlings in Seed Beds: Lab Project Number: 93594: 3594.
Unpublished study prepared by Merck Research Lab.; American Agricultural
Services, Inc. 149 p.
42942801 Kangas, L.; Lankas, G. (1990) Thiabendazole: Fourteen-Week Oral Toxicity
Study in the Albino Rat: Lab Project Number: 84114: 89-9014, Unpublished
68
-------
BIBLIOGRAPHY
MRID
CITATION
study prepared by Bio-Research Labs, Ltd; Merck Institute of Therapeutic
Research. 487 p.
42942802 Myers, B.; Lankas, G. (1990) Thiabendazole: A 14-Week Dietary Toxicity Study
in Rats: Lab Project Number: 284-169: 90-9002. Unpublished study prepared by
Merck Sharp & Dohme Research Labs; Hazleton Labs America, Inc. 383 p.
43172801 Boatright, A. (1994) Determination of the Stability of Thiabendazole in Aqueous
Solutions of Al+3, Fe+3,and Sn+2 and in the Presence of Sunlight: Lab Project
Number: 618-67/63-13. Unpublished study prepared by Merck Research Labs,
Merck & Co., Inc. 31 p.
43187201 Jacobson, B. (1994) Terrestrial Field Dissipation for Thiabendazole in Wheat:
Lab Project Number: 618-360-92530: 37853-3. Unpublished study prepared by
Quails Agricultural Labs, and ABC Labs., Inc. 178 p.
43187202 Jacobson, B, (1994) Terrestrial Field Dissipation for Thiabendazole in Soybeans:
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.
43251501 Arenas, R. (1994) Residue Analytical Enforcement Method for Thiabendazole, 5-
Hydroxythiabendazole, and the Sulfate Conjugate of 5-Hydroxythiabendazole in
Bovine Milk: Lab Project Number: M-028.1. Unpublished study prepared by
Merck Research Lab. and Analytical Dev. Corp. 122 p.
43251502 Arenas, R. (1994) Effect of Freezer Storage on the Magnitude of the Residues of
Thiabendazole, 5-Hydroxythiabendazole, and the Sulfate Conjugate of 5- •
Hydroxythiabendazole in Raw Milk: Lab Project Number: 93857. Unpublished
study prepared by Merck Research Lab. 118 p.
43251503 Arenas, R, (1994) Residue Analytical Enforcement Method for Thiabendazole, 5-
Hydroxythiabendazole, and Benzimidazole in Chicken Egg: Lab Project Number:
M-025.1. Unpublished study prepared by Merck Research Lab. & Analytical
Dev. Corp. 120 p.
43251504 Arenas, R. (1994) Residue Analytical Enforcement Method for Thiabendazole,
5-Hydroxythiabendazole, and Benzimidazole in Animal Tissue: Lab Project
69
-------
BIBLIOGRAPHY
MRID
CITATION
Number: M-027. Unpublished study prepared by Merck Research Lab. &
Analytical Dev. Corp. 169 p.
43251505 Arenas, R. (1994) Effect of Freezer Storage on the Magnitude of the Residues of
Thiabendazole and 5-Hydroxythiabendazole in Animal Tissues: Lab Project
Number: 93897. Unpublished study prepared by Merck Research Lab. 122 p,
43328301 Johnson, N. (1994) Merck Responses to EPA Review Dated 08/04/93-
Thiabendazole-Magnitude of the Residue in Wheat and Wheat Processed
Fractions: Lab Project Number: 618-360-R/8/93: 39296: 40386. Unpublished
study prepared by Merck Research Labs. 23 p.
43328302 Norton, J. (1994) Supplemental Enzyme Hydrolysis Method Final Report:
Determination of the Magnitude of the Residues of the Fungicide Thiabendazole
in Wheat Treated with Menect DF: Lab Project Number: 618-360-93020: 93020:
39296E. Unpublished study prepared by ABC Labs, Inc. 34 p.
43328303 Cooper, J. (1994) Independent Laboratory Confirmation of the Enforcement
Method for Benzimidazole and its Conjugates in Wheat Grain and Wheat Straw
According to PR Notice 88-5 Guidelines: Lab Project Number: 618-360-41871:
41871. Unpublished study prepared by ABC Labs, Inc. 20 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.
43328306 Johnson, N. (1994) Merck Responses to EPA Review Dated
08/04/93-Thiabendazole-Magnitude of the Residue in Citrus and Citrus
Processed Fractions: Lab Project Number: 618-360-R8/93C. Unpublished study
prepared by Merck Research Labs. 50 p.
43328307 Norton, J. (1994) Determination of the Magnitude of the Residues of the
Fungicide Thiabendazole in Citrus Treated with a Dip and Wax Treatment:
Supplemental Data: Lab Project Number: SUPL.-93064: 93064: 001-90-3049R.
Unpublished study prepared by Merck Research Labs. 72 p.
43531001 Johnson, N. (1995) Merck Responses to EPA Reviews of
Thiabendazole-Magnitude of Residue Field Trials with Mushrooms: Lab Project
Number: 618-360-R/l 1161. Unpublished study prepared by Merck & Co., Inc.
28 p.
70
-------
BIBLIOGRAPHY
MRID
CITATION
43531002 Johnson, N. (1995) Merck Responses to EPA Reviews of
Thiabendazole-Magnirude of Residue in Sweet Potato, Potato, and Potato
Processed Fractions: Lab Project Number: 618-360-R/11601. Unpublished study
prepared by Merck & Co., Inc. 75 p.
43547601 Norton, J. (1995) The Determination of the Presence and Magnitude of Residues
of the Fungicide Thiabendazole in Sweet Potatoes Grown from Seed Roots
Treated with MERTECT 340-F: Amended Report: Lab Project Number: 618-360-
92851: 001-90-3037R: ASA 90 NC01. Unpublished study prepared by Merck
Research Labs. 499 p.
43721901 Arenas, R. (1995) Merck Responses to EPA Review Dated 5/16/94-Magnitude
of Residue-Thiabendazole on Bananas: Lab Project Number: 618-360-R-5/94.
Unpublished study prepared by Merck & Co., Inc. 39 p.
43721902 Norton, J. (1995) Determination of the Magnitude of Residue of the Fungicide
Thiabendazole (TBZ) in Green Banana Fruit By Post Harvest Dip Application:
Lab Project Number: 618-360-94346. Unpublished study prepared by Merck &
Co., Inc. 403 p.
43721903 Arenas, R. (1995) Merck Response to EPA Review Dated 8/4/93-Magnitude of
Residue-Thiabendazole in Apples, Pears, and Apple Processed Commodities:
Lab Project Number: 618-360-R-8/93: 3109: 001-90-3060R. Unpublished study
prepared by Merck & Co., Inc. 65 p.
43721904 Norton, J. (1995) Determination of the Magnitude of Residues of the Fungicide
Thiabendazole in/on Citrus Treated with Aqueous Dip and Wax Treatment: Lab
Project Number: 618-360-34168: 4168: 94168. Unpublished study prepared by
Merck & Co., Inc. 827 p.
44724601 Hebert, J. (1998) Product Identity of Mertect Fungicide Manufactured by Hikal
Chemical Laboratories: Final Report. Unpublished study prepared by Jellinek,
Schwartz & Connolly, Inc. 12 p.
44724602 Hebert, J. (1998) Preliminary Analysis, Certification of Ingredient Limits, and
Analytical Method for Enforcement of Limits for Mertect Fungicide: Final
Report: Lab Project Number. Unpublished study prepared by Jellinek, Schwartz
& Connolly, Inc. 8 p.
71
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72
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Appendix £. Generic Data Call-In
See attached table for a list of generic data requirements. Note that a complete Data Call-
in (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
73
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
- SAMPLE COMPANY 2670 Thiabendazole, and salts DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 0601 01 GENERIC
NO CITY. XX 00000 Thiabendazole [Q# GDCH)80101^NNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
-
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Spec fie Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification 1 certify that the statements made on this form and all attachments are true, accurate, and complete. 1 acknowledge that any g rja[e
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of ComDanv's Authorized Representative
10. Name of Company 11. Phone Number I
_____ .. __. . ^^^^•^^^^^•^^^^•^^^^^^^^^^•^^^^^^M
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMR Approval 2070-0107
OMU Approval 2070-0057
INSTRUCTIONS: Please type or print irt ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet{s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case #and Name
2670 Thiabendazole, and salts
Chemical # and Name 060101
Thiabendazole
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-060101-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.1550
830.7050
860.1360
860.1380
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
Product Chemistry Data Requirements (Conventional
Chemical)
Product Identity and composition (1)
UVA/isible absorption
Residue Chemistry Data Requirements for Food Uses
(Conventional Chemical)
Multiresidue method
Storage stability data
Crop field trials(BEAN, DRY, SEED)
Crop field trials(CANTALOUPE)
Crop field trials(SOYBEAN, SEED)
Crop field trials(STRAWBERRY)
Crop field trials(WHEAT, FORAGE)
Crop field trials(WHEAT, HAY)
(30)
(12,13,14
,26)
(17,18,19
.27)
(3 ,4 ,5 ,23)
(20 ,21 ,22
,28)
(6 ,7 ,8 ,24}
(9,10,11
,25)
A, B, C, K, M, O
A, B, C, K, M, O
A, B. C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A. B, C, K, M, O
A, B, C. K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
TEP
TEP
TEP
TEP
TEP
TEP
12
12
12
24
24
24
24
24
24
24
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY
Page 2 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS; Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
860.1500
860.1520
860.1520
870.5300
870.5375
5. Study Title
2. Case # and Name
2670 Thiabendazole, and salts
Chemical # and Name 060101
Thiabendazole
Crop field trials (2)
Processed food/feed(SOYBEAN, SEED) (15 ,16 ,29)
Processed food/feed (31 ,32)
Toxlcoloav Data Requirements (Conventional Chemical)
In vitro mammalian cell gene mutation test
In vitro mammalian chromosome aberration test
p
R
o
T
O
c
o
L
Progress
Reports
1
2
.3
6. Use
Pattern
A. B,C, K.M.O
A, B, C, K, M, O
A. B. C, K. M, 0
A,B,C.K,M(0
A.B.C. K.M.O
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-060101-NNNNN
Initial to indicate certification as to information on this page
rfull *avf nf rorfiftraHnn t -
7. Test
Substance
TEP
8. Time
Frame
(Months)
24
24
24
24
24
9. Registrant
Response
Date
^•^•^^^•^M^^M^^M^B^^
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: GDCI-060101 -NNNNN
Key: TEP = Typical End Use Product [TEPJ
Use Categories Key:
A - Terrestrial food crop K -
6 - Terrestrial feed crop M -
C - Terrestrial nonfood crop O -
Residential
Indoor nonfood use
Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Product Identity & Composition: Revised CSF (830.1550)
Additional residue data required if the registrant intends to support the following commodities: cantaloupe, strawberry, wheat, dry beans, and soybeans.
Required for indoor uses which are direct postharvest treatments of raw agricultural commodities {e.g.. fungicidal waxes or stored grain fumigants).
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
Required for indoor uses which are direct postharvest treatments of raw agricultural commodities {e.g., fungicidal waxes or stored grain fumigants).
Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from toe agricultural use pattern on which the tolerance is established.
Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).
Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).
Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: GDCI-060IOI-NNNNN
Key: TEP = Typical End Use Product [TEPJ
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood croo
K - Residential
M - Indoor nonfood use
O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form,]
15 Data on the nature and level of residues tn processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
16 Required if indoor use could result in pesticide residues in or on food or feed.
17 Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).
18 Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
19 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
20 Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumkjants).
21 Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
22 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
23 Additional residue data required for soybeans. (860.1500)
24 Addtional residue data required on wheat. (860.1500)
25 Additional residue data required on wheat. (860.1500)
26 Additional residue data required on dry beans (if registrant intends to support). (860.1500)
27 Additional residue data required for benzimidazole (free and conjugated in/on cantaloupe and strawberry) for foliar application. (860.1500)
28 Additional residue data required for benzimidazole (free and conjugated in/on cantaloupe and strawberry) for foliar application. (860.1500)
29 Processing study required for the processed fractions of soybeans. (860.1520)
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCl Number: GDCt-060101-NNNNN
Key: TEP = Typical End Use Product [TEP]
Use Categories Key.
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood crop
K - Residential
M - Indoor nonfood use
O - Residential Indoor use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.J
30 Additional storage stability data required for sweet potatoes. (860.1380)
31 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
32 Required if indoor use could result in pesticide residues in or on food or feed.
-------
oo
o
-------
Appendix F. Product Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete
Data Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate
cover.
81
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case* and Name 3. Date and Type of DC! and Number
SAMPLE COMPANY 2670 Thiabendazole, and salts DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 060102 PRODUCT SPECIFIC
NO CITY. XX 00000 Thiabendazole hypophosphite |Q# pDCWB01Q24|NNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. (wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain (he active ingredient
from the source EPA regis-
tration number listed below.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
1 agree to satisfy the EUP ,
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification (certify that the statements made on this form and all attachments are true, accurate, and complete. 1 acknowledge that any g Dale
knowingly false or misleading statement may be punishable by Tine, imprisonment or both under applicable law.
Signature and Title of Comoany's Authorized Representative
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
2670 Thiabendazole, and salts
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060102-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Chemical)
Product Identity and composition
0)
Description of materials used to produce the product (2)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(3)
(34)
(4)
(5 .6 ,7)
(8)
(9)
(14)
(16)
(17)
B, C, D. E, F, G, H. I, J,
K, L
B, C, D, E. F, G, H, I, J.
K, L
B.C.D.E.F.G.H.I. J,
K. L
B, C. D, E, F, G, H, I, J,
K, L
B, C, D, E.F.G. H, I.J,
K, L
B, C, D, E, F, G, H, I, J,
K,L
B.C.D.E.F.G.H.I. J,
K.L
B, C, D, E. F, G. H, I, J,
K, L
B.C.D.E.F.G.H.I. J.
K,L
B.C.D.E.F.G.H.I, J,
K, L
B.C.D.E.F.G.H.I.J,
K.L
EP; MP; TGAI
EP; MP; TGAI
TGAI
MP/EP
EP; MP; TGAI
TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
MP or EP
EP; MP; TGAI
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form,
Use additional sheets) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7300
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
2670 Thiabendazole, and salts DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060102-NNNN
EPA Reg. No. NNNNNN-NNNNN
Oxidizing or reducing action (10)
Flammability (11)
Explodabilrty (12)
Storage stability of product
Miscibilrly (13)
Corrosion characteristics
Dielectric breakdown voltage (15)
pH of water solutions or suspensions (18 ,19)
UVA/isible absorption
Viscosity (20)
[tensity/relative density (21 ,22)
Toxicoloov Data Reauirements (Conventional Chemical)
p
R
O
T
O
C
O
L
Progress "
Reports
1
2
3
6. Use
Pattern
B. C, D, E, F. G, H. ,J,
K. L
B, C. D, E, F,G, H, .J.
K.L
B, C, D, E. F, G, H. .J,
K.L
B. C. D. E. F, G. H, ,J,
K.L
B, C, D. E, F, G, H, ,J,
K.L
B, C. D. E. F, G, H, ,J.
K.L
B.C.D.E, F.G.H, ,J,
K,L
B, C, D, E. F, G. H. ,J.
K.L
B. C, D, E, F, G, H, .J,
K.L
B. C. D. E. F, G. H, I, J.
K.L
B, C, D, E, F, G, H, , J,
K, L
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
EP; MP; TGAI
TGAI & PA1
MP or EP
EP; MP; TGAI
8. Time
Frame
(Months)
B
B
B
8
8
B
B
8
B
B
B
9. Registrant
Response
Date
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Acute Oral Toxicity
Acute dermal toxicity
Acute inhalation toxicity
Acute eye irritation
Acute dermal irritation
Skin sensitization
2. Case # and Name 3. Date and Type of DCI and Number
2670 Thiabendazote, and salts DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060102-NNNN
EPA Reg. No. NNNNNN-NNNNN
(27 .28)
{23 ,24 ,25)
(26)
(29)
(30 ,31)
(32 ,33)
P
R
O
T
O
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
B.C.D, E, F.G, H, ,J,
K,L
B.C. D. E, F.G. H. ,J.
K, L
B. C, D. E. F, G. H, ,J,
K, L
B, C.D, E, F,G, H, ,J,
K,L
B,C.D,E,F,G,H, I.J,
K.L
B. C, D, E, F, G, H. , J.
K, L
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
EP; MP; TGAI
EP; MP; TGAt
EP; MP; TGAI
MP or EP
MP or EP
MP or EP
8. Time
Frame
(Months)
8
B
8
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
Page 1 g_f_3_
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060I02-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP or EP = Manufacturing-Use Product or End-Use Product; MP/EP = Manufacturing-Use
Product. Pure Active Ingredient; TGAf = Technical Grade Active Ingredient [TGAI]; TGAf & PAI = Technical Grade of the Active Ingredient or Pure Active ingredient
Use Categories Key:
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
D - Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J -
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
Forestry use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE fonn.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
3 Data must be provided in accordance with the "Description of Production Process" Section.(158.162}
4 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
5 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
3 Required for TGAIs and products produced by an integrated system.
7 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
9 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
10 Required if the product contains an oxidizing or reducing agent
11 Required when the product contains combustible liquids.
12 Required when the product is potentially explosive.
13 Required if Hie product is an emulsifiable liquid and is to be diluted with petroleum solvents.
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
15 Required if the end-use product is a liquid and is to be used around electrical equipment.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060102-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active ingredient; MP or EP = Manufacturing-Use Product or End-Use Product; MP/EP = Manufacturing-Use
Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI); TGAI & PAI = Technical Grade of the Active Ingredient or Pure Active ingredient
Use Categories Key:
B - Terrestrial feed crop
C - Terrestrial nonfood crop
D - Aquatic food crop
E - Aquatic nonfood outdoor use M -
F - Aquatic nonfood industrial use I -
G - Aquatic non-food residential J -
Greenhouse food crop
Greenhouse nonfood crop
Forestry use
K • Residential
L - Indoor food use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
16 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e.. if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Required if the product is dtspersible with water.
19 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
20 Required if the product is a liquid.
21 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
22 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
23 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
24 Not required if test material is a gas or a highly volatile liquid.
25 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
26 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or parttculate).
27 Not required if test material is a gas or a highly volatile liquid.
28 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152,170(b) or special review
consideration under Section 154.7(a)(1).
29 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 3 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060102-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP or EP - Manufacturing-Use Product or End-Use Product; MP/EP = Manufacturing-Use
Product. Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & PAI = Technical Grade of the Active Ingredient or pure Active ingredient
Use Categories Key:
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
D - Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J -
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
Forestry use
Footnotes: [The following notes are referenced tn column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
30 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
31 Not required if test material is a gas or a highly volatile liquid.
32 Required if repeated dermal exposure is likely to occur under conditions of use.
33 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
34 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
-------
United States Environmental I'roleUion
Agency Washington. IXC. 20460
DATA CALL-IN IU SPONSK
(i\1H A
OMH A
viil .'II7II-IMU7
INSTRUCT IONS' Please type or piint in ink Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1 Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case tt and Name
2670 Thiabendazote, and salts
Chemical # and Name OG0102
Thiabenclazole hypophosphtte
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060102-NNNN
4. EPA
Product
Registration
5 I wish to
cancel this
product regis-
tration volun-
tarily
6 Generic Data
6a I am claiming a Genetic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
liation number listed below.
6h I agiee to satisfy Generic
Data requirements as indicated
on the allachod form entitled
"Requirements Status and
Registrant's Response"
7 Product Specific Data
7a My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirement
Status and Registrant's
Response."
7b My product is an F_UP and
I agree to satisfy the EUP
requirements on the attached
form entilled "Requirements
Status and Registrant's
Response"
NNNNNN-NNNNN
8 Certification I certify thai the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
^cngl»ature and Title of Company's Authorized Representative^.
9 Date
10 Name of Company
11 Phone Number
-------
DRAFT COPY
Page 1 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
2670 Thiabendazole, and salts
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DC) and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060101-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Chemical)
Product Identity and composition
(D
Description of materials used to produce the product (2)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(3)
(4)
(5)
(6 .7 .8)
0)
(10)
(15)
(17)
(18)
A, B, C. D, E,
J, K, L, M, N.
A, B, C, D, E.
J, K. L. M, N.
A. B, C, D, E,
J, K, L, M, N.
A. B. C. D. E,
J, K, L, M, N.
A. B, C, D. E,
J. K, L. M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B. C, D, E,
J, K, L. M, N,
A, B, C, D. E,
J. K. L, M, N,
A.B,C,D,E.
J, K, L, M, N.
A. B, C. D, E.
J. K, L, M, N,
A. B, C, D, E,
J, K, L. M, N,
F.G.H, I.
O
F, G. H, I,
O
F, G, H, I,
O
F, G, H, I.
O
F. G, H, I,
O
F, G, H, I,
O
F, G. H, I,
O
F, G, H, I,
O
F, G.H.I,
O
F, G. H. I.
O
F. G. H. I,
0
EP; MP; TGAI
EP; MP; TGAI
TGAI
MP or EP
EP; MP; TGAI
TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
1 ">
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-OI07
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY. XX 00000
4. Guideline
Requirement
Number
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7300
5. Study Title
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibility
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
Density/relative density
2. Case # and Name '3. Date and Type of DCI and Number
2670 Thiabendazole, and salts DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-060101-NNNN
EPA Reg. No. NNNNNN-NNNNN
(11)
(12)
(13)
(14)
(16)
(19 ,20)
(21)
(22 ,23)
Toxicoloav Data Requirements (Conventional Chemical)
Initial to indicate certification as to information on this page
(full text of certification is on page one).
P
R
0
T
O
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
A. B, C.D.E, F, G.H.I,
J.K.L.M, N.O
A, B, C, D. E, F, G, H, I,
J, K, L,M, N, 0
A, B, C. D, E, F, G,H, I,
J. K, L, M. N, O
A, B, C, D, E, F. G.H.I.
J. K, L. M, N, O
A, B, C, D, E, F.G.HJ,
J. K, L, M, N, O
A. B, C, D. E, F, G.H.I.
J, K, L, M, N,O
A,B, C, D, E, F,G, H, I,
J. K, L, M. N, O
A, B, C, D. E, F, G, H, I,
J, K, L, M, N, O
A, B,C, D, E,F, G,H, I,
J, K. L. M. N, O
A, B. C, D, E, F, G, H, I,
J.K.L.M, N.O
A,B.C.D,E,F,G,H,I,
J, K, L, M, N, O
7. Test
Substance
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
EP; MP; TGAI
TGAI & PAI
MP or EP
EP; MP; TGA!
8- Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
i
Date
t
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DRAFT COPY
Page 3 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional 3heet(s) if necessary.
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address 2. Case # and Name 3. Date and Type of DC) and Number
SAMPLE COMPANY 2670 Thiabendazole, and salts DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY. XX 00000 ID # PDCI-060101-NNNN
EPA Reg. No. NNNNNN-NNNNN
4. Guideline
Requirement
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Acute Oral Toxicity (28 .29)
Acute dermal toxicity (24 ,25 ,26)
Acute inhalation toxicity (27)
Acute eye irritation (30)
Acute dermal irritation (31 .32)
Skin sensitization (33 ,34)
p
R
O
T
0
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A. B, C, D, E, F.G.H, I,
J, K, L, M. N, O
A, B. C, D, E. F, G. H, I,
J, K. L. M, N, O
A, B.C.D.E, F.G.H, I,
J, K, L, M, N, O
A.B.C.D.E.F. G.H.I.
J. K, L, M, N, O
A. B, C, D, E, F, G, H, I,
J, K. L, M. N. O
A, B, C, D. E, F. G, H, I,
J. K, L, M. N, O
7. Test
Substance
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
MP or EP
MP or EP
MP or EP
_
8. Time
Frame
(Months)
B
B
8
8
B
8
9. Registrant
Response
Initial to indicate certification as to information on this page I Date
(full text of certification is on paqe one). . 1 1
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060101-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP or EP = Manufacturing-Use Product or End-Use Product; TGAI = Technical Grade Active
Ingredient fTGAI]; TGAI & PAI = Technical Grade of the Active Ingredient or Pure Active ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G - Aquatic non-food residential
Aquatic nonfood outdoor use H - Greenhouse food crop
Aquatic nonfood industrial use I - Greenhouse nonfood crop
J - Forestry use
K - Residential
L- Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
3 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
4 Data must be provided in accordance with the "Description of Formulation Process" Section.O 58.165)
..*!,. ' •'
5 Data must1 fee provided in accordance with the "Description of Formation of Impurities" Section(158.167)
6 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
7 Required for TGAIs and products produced by an integrated system.
8 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
9 Data must be provided in accordance with the "Certified Limits" Sectton(158.175)
10 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158-180)
11 Required if the product contains an oxidizing or reducing agent
12 Required when the product contains combustible liquids.
13 Required when the product is potentially explosive.
14 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
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DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060IOI-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP or EP = Manufacturing-Use Product or End-Use Product; TGAI = Technical Grade Active
Ingredient [TGAI]; TGAI & PAI = Technical Grade of the Active Ingredient or Pure Active ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J - Forestry use
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: fjne following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
16 Required rf the end-use product is a liquid and is to be used around electrical equipment.
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters.
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
19 Required rf the product is dispersibte with water.
20 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e.. if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
21 Required if the product is a liquid.
22 True density or specific density are required for all test substances. Data on bulk density is required for MPs lhat are solid at room temperature,
23 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
24 Not required rf test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
25 Not required if test material is a gas or a highly volatile liquid.
26 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
27 Required if the product consists of. or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
28 Not required if test material is a gas or a highly volatile liquid.
29 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
-------
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2670 Thiabendazole, and salts
DCI Number: PDCI-060101 -NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP or EP = Manufacturing-Use Product or End-Use Product; TGAI = Technical Grade Active
Ingredient [TGAI]; TGAI & PAI = Technical Grade of the Active Ingredient or Pure Active ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J - Forestry use
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
30 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
31 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
32 Not required if test material is a gas or a highly volatile liquid.
33 Required if repeated dermal exposure is likely to occur under conditions of use.
34 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
Appendix G. EPA's Batching of Thiabendazole Products for Meeting Acute Toxicity Data
Requirements For Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistratipn of products containing thiabendazole as the
active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6).
96
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If a registrant depends on another's data, he/she must choose among: Cost Sharing
(Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant
does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a
registrant should know that choosing not to participate in a batch does not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those
studies. f'j; ,
Thirty nine products were found which contain thiabendazole as the active ingredient.
These products have been placed into four batches and a "No Batch" category in accordance with
the active and inert ingredients and type of formulation. Furthermore, the following bridging
strategies are deemed acceptable for this chemical:
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch 1
EPA Reg. No.
100-963
1706-196
2792-50
2792-71
5202-23
5202-24
5202-26
8764-50
43410-7
43410-33
64864-47
% Active Ingredient
99.5
98.5
98.5
98.5
98.5
98.5
98.5
98.5
98.5
98.5
98.5 -
Batch 2
EPA Reg. No.
1706-190
1706-207 .
47332-7
62366-1
% Active Ingredient
50.0
50.0
50.0
50.0
97
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Batch 3
EPA Reg. No.
100-890
7501-134
% Active Ingredient
30,0
30.0
Batch 4
EPA Reg. No,
2935-417
34704-206
% Active Ingredient
0,5
0.5
No Batch
EPA Reg. No.
100-889
400-438
400-439
1381-162
1381-163
1381-169
1706-221
1706-222
2792-35
2792-36
2935-497
2935-498
5202-17
7501-131
% Active Ingredient
42.30
Thiabendazole: 2.50
Carboxin: 27.80
Imazalil: 2.00.
Thiabendazole: 2.70
Carboxin: 32.60
Thiabendazole: 0.35
Thiram: 12.62
Thiabendazole: 0.33
Thiram: 1 1 .64
Thiabendazole: 2,00
Maneb: 50.00
25,00
50.00
Thiabendazole: 0.10
0.20
Thiabendazole: 0.54
Lindane: 10.30
Maneb: 13.60
Thiabendazole: 1.00
Lindane: 18.75
Maneb: 25.00
Thiabendazole: 0.20
Thiabendazole: 1.00
Captan: 20.25
PCNB: 8.40
98
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No Batch
EPA Reg. No.
7501-135
7501-166
8764-12
8764-40
64864-44
64864^6
% Active Ingredient
Thiabendazole: 0.34
Thiram: 12.60
Thiabendazole: 1.50
Carboxin: 16.70
Imazalil: 1 .20
5.00
0.10
3.00
0.10
99
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100
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Appendix H. List of Registrants Sent This Data Call-In
101
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United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
100
400
1381
2792
2935
5202
7501
8764
34704
39967
40810
43410
47332
62366
64864
69691
Case # and Name: 2670,Thiabendazole, and salts
Company Name Agent For
SYNGENTA CROP PROTECTION,
INC.
CROMPTON MANUFACTURING
COMPANY. INC.
AGRILIANCE, LLC
DECCO, CEREXAGRI, INC.
WILBUR ELLIS CO.
BROGDEX COMPANY
GUSTAFSON LLC
FMC TECHNOLOGIES. INC.
LOVELAND PRODUCTS. INC.
BAYER CHEMICALS
CORPORATION
CIBA SPECIALTY CHEMICALS
CORPORATION
AGRI-CHEM. INC.
WALLA WALLA ENVIRONMENTAL.
INC.
THE VALSPAR CORPORATION REGWEST COMPANY, LLC
PACE INTERNATIONAL LLC
MONEY'S FOODS U.S. INC.
Address
POBox 18300
74 AMITY RD
PO BOX 64089
1713 S CALIFORNIA AVE
POBox 1286
1441 W. SECOND STREET
PO Box 660065
1540 LINDEN ST
POBox 1286
100 BAYER ROAD
540 WHITE PLAINS RD
622 1E MYERS BLVD.
POBox 1298
30856 ROCKY ROAD
1011 WESTERN AVENUE, SUITE 807
PO Box 351 845 INTERSTATE DRIVE
City & State
GREENSBORO
BETHANY
ST. PAUL
MONROVIA
FRESNO
POMONA
DALLAS
RIVERSIDE
GREELEY
PITTSBURGH
TARRYTOWN
MASCOTLE
WALLA WALLA
GREELEY
SEATTLE
NAPOLEON
Zip
NC 274198300
CT 065243402
MN 551640089
CA 910160120
CA 93715
CA 91766
TX 75266
CA 92507
CO 806321286
PA 15205
NY 105919005
FL 34753
WA 99362
CO 806319375
WA98104
OH 43545
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Appendix 1. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams
at (703) 308-5551 or by e-mail at williams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution
of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration
of a Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for Development
of Data
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprdOOI/forms/8570-5.pdf.
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.gov/opprd001/forms/8570-27.pdf
http://www.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf
103
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8570-34
8570-35
8570-36
8570-37
Certification with Respect to Citations of Data (in
PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in
PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice 98-1)
http://www.epa.gov/oppprasdl/PR_Notices/pr98-5.pdf,
http://www.epa.gov/opppmsdl/PR_Notices/pr98-5.pdf.
http://www.epa.gov/opppmsd 1 /PR_Notices/pr98- 1 .pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-l.pdf.
Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesticides/registrationkit/.
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2, Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsd l/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulatpr's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
104
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a.
b.
c.
d.
e.
Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPP0) Contacts
Antimicrobials Division Organizational Structure/Contact List
53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
40 CFR Part 158, Data Requirements for Registration (PDF format)
50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs1 Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road .
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently
in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the
Office of Pesticide Programs. We anticipate that this publication will become
available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides. You
can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. e du/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
105
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Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for
the new submission. The identifying number should be used whenever you contact
the Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which
identify the chemical (including "blind" codes used when a sample was submitted
for testing by commercial or academic facilities). Please provide a CAS number if
one has been assigned.
Documents Associated with this RED
The following documents are pan of the Administrative Record for this RED document and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents
are not available electronically, but may be obtained by contacting the person listed on the
respective Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
106
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