United States Prevention, Pesticides EPA 738-R-99-006
Environmental Protection And Toxic Substances December 1999
Agency (7508C)
&EPA Reregistration
Eligibility Decision (RED)
EPTC
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-99-011
September 1999
&EPA. R.E.D. FACTS
Pesticide
Reregistration
EPIC
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. To implement provisions of the
Food Quality Protection Act of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public
to pesticide residues from all sources, and the cumulative effects of pesticides
and other compounds with common mechanisms of toxicity. The Agency
develops any mitigation measures or regulatory controls needed to effectively
reduce each pesticide's risks. EPA then reregisters pesticides that meet the
safety standard of the FQPA and can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
0064, EPTC (S-Ethyl dipropylthiocarbamate).
Use Profile
The following active ingredient is covered by this Fact Sheet:
Common Name:
Chemical Name:
Chemical Family:
Type of Chemical:
EPTC
S-Ethyl dipropylthiocarbamate
Thiocarbamate
Herbicide
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CAS Registry Number: 759-94-4
OPP Chemical Code: 041401
Empirical Formula: C9H19NOS
Basic Manufacturer: Zeneca Ag Products
EPTC is a pre-emergence and early post-emergence thiocarbamate
herbicide used to control the growth of germinating annual weeds, including
broadleaves, grasses, and sedges. It is used in every region of the United
States in the agricultural production of a wide variety of food crops. The
heaviest usage is in the Corn Belt, Northeastern and Mid-Atlantic states,
Coastal and Northern Great Plains and in the Pacific Northwest. Highest use
states are California, Michigan, Oregon, Pennsylvania, North Dakota,
Minnesota, and Arizona. The largest markets in terms of total pounds of
active ingredient are corn, potatoes, dry beans, peas, alfalfa, and snap beans.
Usage ranges from about 10 to 20 million pounds a.i. annually. EPTC is also
available to the residential home gardener for use in vegetable and ornamental
gardens.
As with other thiocarbamate herbicides, EPTC exerts its herbicidal action
through inhibition of cuticle formation at the early stages of seedling growth.
Formulated products include emulsifiable concentrate (EC) liquids containing
up to 87.8% active ingredient and granular (G) formulations containing up to
25% active ingredient. EPTC is typically applied annually in one to three
applications, with each application ranging from about 2 to 6.1 Ibs a.i./acre
(maximum rate 7.5 to 12.2 Ibs a.i./acre for alfalfa and potatoes). EPTC can
either be applied by aerial or ground equipment or through chemigation.
Because of its chemical properties, however it is applied, it must be
incorporated into the soil immediately after application to prevent
volatilization.
Regulatory History EPTC was registered in the United States in 1958 for use as a selective
preemergent herbicide, and was originally owned by Stauffer Chemical
Company. Chemiolimpex, a technical EPTC (TGAI), was manufactured in
Hungary, and was imported into the United States by PPG Industries of
Pittsburgh, Pennsylvania. Zeneca Ag Products currently holds registrations for
several end-use products, and holds the only registration for the technical
product.
A Registration Standard for EPTC was issued in September 1993. The
Agency determined that additional generic data would have to be submitted for
evaluation in order to maintain registration. This RED reflects a reassessment
of all data which were submitted in response to the Registration Standard.
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Human Health
Assessment
Toxicity results of acute toxicity, primary eye and dermal irritation, and
dermal sensitization studies with EPIC technical material are summarized in
the RED. EPTC is moderately toxic (Toxicity Category III) via the oral and
dermal routes, and in a primary eye irritation study in rabbits, the technical
was found to be slightly irritating (Toxicity Category III). EPTC is most toxic
via the inhalation route (Toxicity Category II).
There was an increased incidence and severity of cardiomyopathy and
neuronal necrosis/degeneration in studies performed in the central and
peripheral nervous systems of both rats and dogs. The neurotoxic effects of
EPTC are consistent with effects seen in other thiocarbamates. Because of
these effects (neuronal necrosis/degeneration), and the potential for residential
exposure to infants and children from use of EPTC, the Agency's FQPA
Safely Factor Committee recommended that the lOx FQPA safety factor be
retained for all population subgroups for acute, chronic and residential
exposure assessments.
Although it appears that EPTC did not produce any significant
reproductive or developmental toxicity, there is still uncertainty regarding the
effects on the developing fetal nervous system This uncertainty is being
addressed by the requirement of a developmental neurotoxicity study in rats.
EPTC effects were also negative in two oncogenicity studies.
Occupational and Residential Exposure
Occupational and residential exposure to EPTC residues via dermal and
inhalation routes can occur during handling activities such as mixing, loading,
and applying; however, the potential for postapplication occupational exposure
is minimal. Because EPTC is applied as a soil directed spray and immediately
incorporated, or as a soil injection well before plants are mature, the potential
for postapplication dermal exposure during harvest activities is minimal. In
addition, there is a potential for inadvertent oral exposure to children from
eating EPTC-treated soil and/or granules. Based on toxicological criteria and
potential for exposure, the Agency has conducted dermal and inhalation
exposure assessments for the occupational and residential handler, and for
residential postapplication inadvertent oral ingestion soil/granulars exposure to
children.
Potential EPTC residential use sites may include a variety of shade trees,
evergreens, and annual or perennial ornamentals. EPTC is typically applied
only to bare soil once before planting or after weeding under ornamentals
followed by soil incorporation. Examples of typical usage of a granular
formulation in the home garden would include pre-planted application and
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incorporation with a rototiller, post-plant application incorporated into the
soils to a depth of 2-3 inches using a hand rake or hoe, and weed control in
established trees and shrubs by incorporation into the top 6 inches of soil In
contrast to occupational workers, individuals in residential settings are more
likely to transplant seedlings and plant seeds by hand. In addition, there is a
potential for inadvertent oral exposure to children from eating EPTC-treated
soil and/or granules.
Human Risk Assessment
Dietary Exposure
Risk from food and water combined are acceptable. And the Tier 1
acute dietary exposure analysis of EPTC, exposure (food consumption) was
compared to an acute population adjusted dose of 0.067 mg/kg/day. The acute
dietary risk analysis estimates the distribution of single day exposures for the
overall U.S. population and certain subgroups. The analysis evaluates
exposure to the chemical for each food commodity, and assumes uniform
distribution of EPTC in the food supply.
The acute dietary residue contribution at the 95th percentile occupied less
than 100% of the aPAD for any population subgroup, and therefore does not
exceed the Agency's level of concern. For non-probalistic acute dietary
exposure the Agency uses the 95th percentile. For the most highly exposed
subgroup, children 1-6, residue contribution occupied 87.5% of the aPAD.
This Tier 1 acute analysis for EPTC is a conservative upper-bound estimate
with all input residues equal to the reassessed tolerance value and the
assumption that 100% of the crop is treated nationwide.
Environmental Fate
The environmental fate data indicates that EPTC would not be persistent
under many environmental conditions, which is supported by relatively short
half-lives observed in terrestrial and low aquatic concentrations. Monitoring
data suggests that concentrations of EPTC in ground water will be less than
those found in surface water. However, the persistence of EPTC in ground
water would probably be greater than in surface water because losses due to
volatilization would be expected to be much less.
The low affinity for binding to soil and water solubility also suggest a
potential to leach, but since EPTC generally does not persist long in surface
soils, the potential to leach is greatly reduced.
Environmental Ecological Effects
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Assessment EPTC is practically non-toxic to birds and bees; slightly toxic to
mammals and fish, and moderately toxic to aquatic invetebrates, algae and an
aquatic vascular plant. Toxicity studies are unavailable for estuarine species.
Reproduction studies are not available for any species, except laboratory
mammals. Due to lack of data, acute risks to estuarine species, and
reproductive risks to birds, fish and aquatic invertebrates were not assessed.
The registrant will be required to provide additional data in order to evaluated
the potential effects of bird, aquatic and estuarine species.
EPTC is toxic to both monocot and dicot plant species. Although EPTC
is a pre-emergent herbicide, it may cause some phytotoxic damage and growth
effects on established plants. Risk quotients for granular and spray
applications suggest that EPTC poses adverse effects on non-target plants for
all uses.
Environmental Risk Characterization
Residue levels of EPTC on vegetation exceed levels of concern for high
acute risks and effect on endangered species for small mammals. Soil
incorporation reduces the amount of vegetation exposed, but the vegetation
remaining at the surface poses a potential risk to small mammals. Given the
low probability of EPTC dietary exposure to small mammals, any mortality is
unlikely to have any serious effect on the local populations of small mammals,
with the exception of an endangered species.
The level of concern is exceeded for endangered and terrestrial plants
species such as monocots and dicots. Non-target terrestrial plants in adjacent
fields or habitats are potentially at risk from spray drift from some uses and
from runoff for all registered uses. EPTC also appears to have the potential to
be transported off site via the vapor phase as it was one of a number of
residues found in more than 25 percent of the rain samples collected in three
water sheds in Minnesota. In addition, being a herbicide, EPTC may also have
an indirect effect on endangered insects by adversely affecting the plants on
which they depend.
The levels of EPTC that are likely to be atmospherically deposited into
soils or on vegetation is uncertain. The absence of reported atmospheric
deposition incidences does not preclude the occurrence of such events. The
registrant will be required to provide additional data on field volatility and
atmospheric dissipation in order to further evaluate the environmental fate of
EPTC.
Although the EPTC data base is sufficient to render a reregi strati on
eligibility decision, additional confirmatory data such as developmental
neurotoxicity, residue analytical methods-plant, and Multiresidue method
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r» • i T» /r'-L- -L-
Risk Mitigation
studies are needed to further assess the chemical's toxicity. In addition,
ecological effects and environmental fate studies are needed to fully assess the
impact of EPTC and its primary degradates on the environment.
To lessen the risks posed by EPTC, EPA is requiring the following risk
mitigation measures:
The exposure assessments indicate that occupational handlers are at risk
to dermal and inhalation exposure, and that additional protective
measures are necessary to reduce these risks. Therefore, various forms
of additional personal protective equipment (PPE) (e.g., double layer
clothing and respirators) and engineering controls (e.g., enclosed
cockpits) are necessary for certain handler scenarios to reduce the risks
to below the Agency's level of concern.
In order to mitigate risks to homeowners, the registrant will be required
to add label language which prohibit use of the belly grinder, which
contributes to the highest level of exposure, for home owner products.
The registrant will also be required to delete all residential emulsifiable
concentrate formulation uses from the EPTAM 7E label. In addition,
the registrant will be required to change the maximum rate of 15 Ibs per
acre for the Eptam 2.3 granular products to the typical rate of 5 Ibs per
acre for residential products.
Additional Data
Required
Risk quotients for granular and spray applications suggest that EPTC
poses adverse effects to small herbivorous and insectivorous mammals
for most uses and adverse effects on non-target terrestrial plants for all
uses. EPTC use could also cause adverse effects on endangered species.
As a member of the Endangered Species Task Force, the registrant will
be required to obtain information which identifies endangered and
threatened species of concern which may be found in areas adjacent to
crops treated with EPTC.
EPA is requiring the following additional generic studies for EPTC to
its regulatory assessments and conclusions.
Guideline:
870.6300
860. 1 340
860. 1360
860. 1 3 80
Developmental neurotoxicity study in the rat
Residue Analytical methods-Plant
Multiresidue Method
Storage Stability Data
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Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
860.1520
860.1500
Guideline:
850.2100
850.2300
850.1400
835.4100
835.4200
835.4300
835.8100
835.6100
850.1730
Processed Food/ Feed
Crop field Trials
Study:
Acute Avian Oral (quail/duck)
Avian Reproduction Quail/Duck
Fish Early Life Stage
Aerobic Soil
Anaerobic Soil
Aerobic Aquatic Metabolism
Field Volatility
Field Dissipation
Aquatic Organism Accumulation
Before reregistering the products containing EPTC, the Agency is
requiring that product specific data, revised Confidential Statements of
Formula (CSF), and revised labeling be submitted within eight months of the
issuance of this document. These data include product chemistry for each
registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5)
of FIFRA, the Agency will reregister a product. Those products which contain
other active ingredients will be eligible for reregi strati on only when the other
active ingredients are determined to be eligible for reregistration. All EPTC
end-use products must comply with EPA's current pesticide product labeling
requirements and. For a comprehensive list of labeling requirements, please
see the EPTC RED document.
The use of currently registered products containing EPTC 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.
EPA has determined that products containing EPTC are eligible for
reregistration. The use of eligible EPTC products in accordance with labeling
specified in this RED will not pose unreasonable adverse effects to humans or
the environment. These products will be reregistered once the required
confirmatory generic data, product specific data, CSFs, and revised labeling are
received and accepted by EPA. Products which contain active ingredients in
addition to EPTC will be reregistered when all of their other active ingredients
also are eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for EPTC during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
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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 513-489-8695.
Following the comment period, the EPTC RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 703-605-6000.
For more information about EPA's pesticide reregi strati on program, the
EPTC RED, or reregi strati on of individual products containing EPTC, please
contact the Special Review and Reregi strati on 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 Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, from 6:30 am to 4:30 pm, Pacific Standard Time, or 9:30 am
to 7:30 pm, Eastern Standard Time, seven days a week.
Their internet address is ace.orst.edu/info/nptn.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decision on the pesticide chemical case which includes the
active ingredient EPTC. The enclosed Reregistration Eligibility Decision (RED), which was
approved on September 30, 1999, contains the Agency's evaluation of the data base of this
chemical, its conclusions of the potential human health and environmental risks of the current
product uses, and its decisions and conditions under which these uses and products will be eligible
for reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that, in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
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If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Venus
Eagle-Kunst (703) 308-8045. Address any questions on required generic data to the Special
Review and Reregistration Division representative Jamil Mixon at (703) 308-8032.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number (703) 605-6000).
c. Generic or Product Specific Data Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
EPTC (S-Ethyl dipropylthiocarbamate)
CASE # 0064
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TABLE OF CONTENTS
EPTC REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Methods and Rates of Application and Target Weeds 3
D. Estimated Usage of Pesticide 5
E. Data Requirements 7
F. Regulatory History 8
III. SCIENCE ASSESSMENT 8
A. Physical Chemistry Assessment 8
1. Chemical Profile 8
2. Environmental Fate Summary 9
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 11
b. Chronic Toxicity/Carcinogenicity 11
c. Developmental & Reproductive Toxicity 11
d. Mutagenicity 12
e. Dermal Absorption 12
f. Metabolism 12
g. Other Toxicological Endpoints 12
2. Dose Response Assessment 13
a. FQPA Considerations 13
b. Cancer Classification 14
c. Reference Dose and Toxicological Endpoints 14
3. Exposure Assessment 16
a. Dietary Exposure 16
b. Dietary Exposure from Food 18
(1) Acute Dietary Exposure Assessment 19
(2) Chronic Dietary Exposure Assessment 20
c. Dietary Exposure from Drinking Water 20
d. Occupational and Non-Occupational Exposures 23
e. Occupational Exposure 24
f. Incident Reports 25
g. Residential Handler Exposure 25
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4. Risk Characterization 27
a. Dietary Risk 27
b. Occupational Handler Risk 28
c. Residential Handler Risk Characterization 35
d. Cumulative Effects 37
e. Aggregate Risk Assessment 38
C. Environmental Assessment 40
1. Ecological Toxicity Data 40
a. Toxicity to Terrestrial Animals 40
b. Toxicity to Aquatic Animals 41
c. Toxicity to Terrestrial Plants 41
2. Environmental Fate 42
a. Environmental Fate Assessment 42
b. Environmental Fate and Transport Data 44
c. Water Resources 53
3. Exposure and Risk Characterization 55
a. Ecological Exposure and Risk Characterization 56
b. Environmental Risk Characterization 64
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 67
A. Determination of Eligibility 67
1. Eligibility Decision 67
2. Eligible and Ineligible Uses 67
B. Regulatory Position 67
1. Food Quality Protection Act Findings 69
a. Determination of Safety for U.S. Population 69
b. Determination of Safety for Infants and Children 70
2. Tolerance Reassessment Summary 70
3. Codex Harmonization 76
4. Risk Mitigation 76
a. Risk Mitigation for Occupational Handler Exposure 76
b. Risk Mitigation for Residential Handler Exposure 80
c. Ecological Risk Mitigation 82
(1) Mammalian Mitigation 82
(2) Terrestrial Plant Mitigation 82
V. Actions Required of Registrant 83
A. Data Requirements 83
B. Labeling Requirements 83
C. Existing Stocks 94
VI. APPENDICES 95
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR
REREGISTRATION 97
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND
STUDIES USED TO MAKE THE REREGISTRATION
DECISION 107
Appendix C. CITATIONS CONSIDERED TO BE PART OF THE DATA
BASE SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY) 113
Appendix D. GENERIC DATA CALL-IN 135
1. EPTC Data Call-In Chemical Status Sheet 152
2. Generic DCI Response Forms Inserts Plus Instructions
153
3. Requirements Status and Registrant' Response Forms
Plus Instructions 156
Appendix E. PRODUCT SPECIFIC DATA CALL-IN 166
1. Product Specific Chemical Status Sheet 179
2. Data Call-In Response Form for the Product Specific
Data Plus Instructions 180
3. Product Specific Requirement Status and Registrant's
Response Forms Plus Instructions 183
4. EPA'S Batching of EPTC Products for Meeting Acute
Toxicity Data Requirements for Reregistration ... 190
5. List of All registrants sent this Data call-In 192
Appendix F. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 195
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EPTC REREGISTRATION ELIGIBILITY DECISION TEAM
Biological and Economic Analysis
Rafael Prieto
Jihad Alsadek
James Saulmon
Environmental Fate and Effects Assessment
Daniel Rieder
James K. Wolf
William Rabert
Science Information and Analysis Branch
Economic Analysis Branch
Herbicide & Insecticide Branch
Environmental Risk Branch III
Environmental Risk Branch III
Environmental Risk Branch III
Health Effects Division
Paula A. Deschamp
Ken W. Dockter
Stephen C. DeVito
Robert F. Fricke
Renee Sandvig
Carol Christensen
Jerome Blondell
Monica Spann
Registration Division
Jim Tompkins
Tobi Colvin-Snyder
Special Review & Reregistration Division
Mark Wilhite
Jamil Mixon
Non-Dietary Human Risk Management
Steve Merrill
Rich Dumas
Deanna Scher
Katherine Boyle
Daniel Helfgott
Reregistration Branch II
Reregistration Branch II
Reregistration Branch II
Reregistration Branch II
Reregistration Branch II
Reregistration Branch II
Chemistry & Exposure Branch I
Chemistry & Exposure Branch I
Herbicide Branch
Herbicide Branch
Reregistration Branch I
Reregistration Branch I
Product Reregistration Branch
Reregistration Branch II
Reregistration Branch I
Reregistration Branch II
Special Review Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
ChE Cholinesterase
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration.
The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., ppm, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
/-ig/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dosage
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section
24cofFIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
EPA has completed its reregi strati on eligibility assessment for the pesticide S-ethyl
dipropylthiocarbamate (EPIC) and determined that the data are adequate to support a reregi strati on
eligibility decision. This decision includes a comprehensive reassessment of the required target data
base supporting the use patterns of currently registered products. This decision considered the
requirements of the "Food Quality Protection Act of 1996" (FQPA) which amended the Federal Food
Drug and Cosmetic Act (FFDCA) and the Federal Insecticide Fungicide and Rodenticide Act
(FIFRA) the two Federal statutes that provide the framework for pesticide regulation in the United
States.
In establishing or reassessing tolerances, FQPA requires the Agency to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures for
which there is reliable information, as well as the potential for cumulative effects from a pesticide and
other compounds with a common mechanism of toxicity. The Act further directs EPA to consider
the potential for increased susceptibility of infants and children to the toxic effects of pesticide
residues, and to develop a screening program to determine whether pesticides produce endocrine
disrupting effects.
In September 1999, the Agency presented a paper on the common mechanism of toxicity of
the carbamate pesticides to the Science Advisory Panel (SAP). In that presentation, the Agency
noted that although various classes of compounds may inhibit acetyl cholinesterase, the potency,
reversibility, and related factors may influence whether or not related pesticides should be included
in a cumulative risk assessment. The Agency is currently awaiting a report from the SAP.
At this time, the Agency does not believe it has sufficient reliable information concerning
common mechanism issues to determine whether EPTC, a thiocarbamate, shares a common
mechanism of toxicity with other cholinesterase-inhibiting chemicals. Therefore, for the purposes of
this tolerance reassessment, the Agency has assumed that EPTC does not share a common mechanism
of toxicity with cholinesterase-inhibiting chemicals.
EPTC is a pre-emergence and early post-emergence thiocarbamate herbicide used to control
the growth of germinating annual weeds, and grasses in a variety of food crops. The largest market
in terms of total pounds active ingredient are corn, potatoes, dry beans, peas, alfalfa, and snapbeans
There are also registered home garden uses in vegetable and ornamental gardens. EPTC can either
be applied by ground equipment, through irrigation and aerial for granular only. Because of its
chemical properties, it must be incorporated into the soil immediately after application to prevent
volatilization.
EPTC is moderately toxic via the dermal and oral routes and is highly toxic via the inhalation
route. Also, there was an increased incidence and severity of cardiomyopathy and neuronal
necrosis/degeneration in studies performed in the central and peripheral nervous systems of both rats
and dogs. The neurotoxic effects of EPTC are consistent with effects seen in other thiocarbamates.
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Because of these effects (neuronal necrosis/degeneration), and the potential for residential exposure
to infants and children from use of EPIC, the Agency's FQPA Safety Factor Committee
recommended that the lOx FQPA safety factor be retained for all population subgroups for acute,
chronic and residential exposure assessments. Although it appears that EPIC did not produce any
significant reproductive or developmental toxicity, there is still uncertainty regarding the effects on
the developing fetal nervous system after such exposure. This uncertainty is being addressed by the
requirement of a developmental neurotoxicity study in rats. EPTC effects were also negative in two
oncogenicity studies.
Several of the residential and occupational handler scenarios exceed the Agency's level of
concern. These exposure risks are mitigated, as specified in Chapter IV of this Document, with
additional Personal Protective Equipment (PPE), engineering controls, or in the case of residential
exposure, use rate reduction and label changes. Postapplication risk estimates were conducted for
only one scenario: inadvertent soil ingestion by infants/children resulting from hand-to-mouth
behavior. The MOE estimated for this scenario is substantially less than the Agency's level of concern.
Acute and chronic risk from food do not exceed the Agency's level of concern. In both
assessments, exposure (consumption) was compared to a population adjusted dose (PAD) reflecting
retention of the FQPA lOx factor. The PAD is equal to the acute or chronic RfD divided by the
FQPA Safety Factor. The Agency considers dietary residue contributions greater than 100% of the
PAD to be of concern. Acute dietary exposure comprised 40.5% of the aPAD for the general
population, and 87.5% of the aPAD for the most highly exposed subgroup, children (1-6 years).
Chronic dietary exposure comprised 9.6% of the cPAD for the general population, and 17.4% of the
cPAD for the most highly exposed subgroup, children (1-6 years).
EPTC was rarely detected in groundwater (less than 2% of samples), but more frequently
detected in surface water monitoring data (4% to 25%). Established water concentrations of EPTC
do not exceed any Drinking Water Level of comparison (DWLOCs). The available monitoring data
support this conclusion.
Aggregate acute dietary risk estimates do not exceed the Agency's level of concern. The
aggregate acute dietary risk estimates include exposure to EPTC residues in food and water. Acute
dietary exposure from food was 87.5% of the acute PAD, and was not of concern. Based on the
available information, the Agency concludes with reasonable certainty that no harm to any population
will result from acute aggregate dietary exposure to EPTC.
Short-term aggregate and chronic aggregate risk estimates do not exceed Agency's level of
concern. Short term aggregate risk estimates for adults include exposure to EPTC residues in food,
water, and high-end non-occupational use in residential settings (applying granules by hand/spoon).
Although short-term dermal and inhalation exposures are anticipated during handling and applying
EPTC, the endpoint effect selected for inhalation risk differs from the endpoint effect selected for
dermal and oral risk. Therefore, the inhalation route of exposure does not contribute to the aggregate
risk estimate. Short-term aggregate risk estimates for infants/children include exposure to EPTC
VI
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residues in food, water, and from inadvertent oral soil ingestion resulting from hand-to-mouth
behavior. Chronic aggregate (non-cancer) risk estimates do not exceed the Agency's level of
concern. The chronic aggregate dietary risk estimates include exposure to EPTC residues in food
and water.
The environmental fate data indicates that EPTC would not be persistent under many
environmental conditions, which is supported by relatively short half-lives observed in terrestrial and
low aquatic concentrations. Monitoring data suggests that concentrations of EPTC in ground water
will be less than those found in surface water. However, the persistence of EPTC in ground water
would probably be greater than in surface water because losses due to volatilization would be
expected to be much less.
The low affinity for binding to soil and water solubility also suggest a potential to leach, but
since EPTC generally does not persist long in surface soils, the potential to leach is greatly reduced.
EPTC is practically non-toxic to birds and bees; slightly toxic to mammals and fish, and
moderately toxic to aquatic invetebrates, algae and an aquatic vascular plant. Toxicity studies are
unavailable for estuarine species. Reproduction studies are not available for any species, except
laboratory mammals. Due to lack of data, acute risks to estuarine species, and reproductive risks to
birds, fish and aquatic invertebrates were not assessed. The registrant will be required to provide
additional data in order to evaluate the potential effects of bird, aquatic and estuarine species.
Toxicity rating categories have not been established for terrestrial plants. EPTC is toxic to
both monocot and dicot plant species. Although EPTC is a pre-emergent herbicide, it may cause
some phytotoxic damage and growth effects on established plants. Risk quotients for granular and
spray applications suggest that EPTC poses adverse effects on non-target plants for all uses.
Residue levels of EPTC on vegetation exceed levels of concern for high acute risks and effect
on endangered species for small mammals. Soil incorporation reduces the amount of vegetation
exposed, but the vegetation remaining at the surface poses a potential risk to small mammals. Since
soil incorporation is necessary within the 24 hours specified on the label for good weed control,
exposed vegetation on the field surface after soil incorporation will be sparse. The scarcity of the
treated vegetation and the rapid volatilization of EPTC from the exposed vegetation in the couple
days, reduces the magnitude and possibility of risks to a short time period. The scarcity of the
vegetation in the field is less inviting for hungry mammals than vegetative areas surrounding the field,
which also lowers the probability that many small mammals will feed in the field and will be affected
by EPTC. Given the low probability of EPTC dietary exposure to small mammals, any mortality is
unlikely to have any serious effect on the local populations of small mammals, with the exception of
an endangered species.
Being a herbicide, EPTC may have an indirect effect on endangered insects by adversely
affecting the plants on which they depend. As member of the Endangered Species Task Force, the
vn
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registrant will be required to obtain information which identifies endangered and threatened species
of concern which may be found in areas adjacent to crops treated with EPIC.
Whether these levels of EPIC are likely to be atmospherically deposited into soils or on
vegetation is uncertain. The absence of reported atmospheric deposition incidences does not preclude
the occurrence of such events. The registrant will be required to provide additional data on field
volatility and atmospheric dissipation in order to further evaluate the environmental fate of EPTC.
Although the EPTC data base is sufficient to render a reregistration eligibility decision,
additional confirmatory data such as developmental neurotoxicity, residue analytical methods-plant,
and Multiresidue method studies are needed. In addition, ecological effects and environmental fate
studies are needed to fully assess the impact of EPTC and its primary degradates on the environment.
Before reregistering the products containing EPTC, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF), and revised labeling be submitted
within eight months of the issuance of this document. These data include product chemistry for each
registration and acute toxicity testing. After reviewing these data and any revised labels and finding
them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product.
Those products which contain other active ingredients will be eligible for reregistration only when
the other active ingredients are determined to be eligible for reregistration.
The exposure assessments indicate that occupational handlers are at risk to dermal and
inhalation exposure, and that additional protective measures are necessary to reduce these risks.
Therefore, various forms of additional personal protective equipment (PPE), are necessary for
certain handler scenarios to reduce the risks to below the Agency's level of concern. In order to
mitigate risks to homeowners, the registrant will be required to add label language which prohibit the
use of specific application tools, which contributes to the highest level of exposure, drop all
residential emulsifiable concentrate formulation uses, and change the maximum granular application
rate to the typical rate for residential products.
Vlll
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregi strati on process to be completed in nine years.
There are five phases to the reregi strati on process. The first four phases of the process focus on
identification of data requirements to support the reregi strati on of an active ingredient and the
generation and the submission of data to fulfill the requirements. The fifth phase is a review by the
U.S. Environmental Protection Agency (referred to as "The Agency") of all data submitted to
support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredients are eligible for reregi strati on" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregi strati on involves a thorough review of the scientific data base 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" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq. The FQPA amendments went into effect immediately. As a result, EPA is embarking on
an intensive process, including consultation with registrants, States tribes and other interested
stakeholders, to make decisions on the new policies and procedures that will be appropriate as a result
of enactment of FQPA. This process will include a more in depth analysis of the new safely standard
and how it should be applied to both food and non-food use pesticides. The FQPA does not,
however, amend any of the existing reregistration deadlines set forth in §4 of FIFRA. In addition,
in light of the unaffected statutory deadlines with respect to reregistration, the Agency will continue
its ongoing reregistration program while it continues to determine how best to implement FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of EPTC, including the risk to infants and children for any potential dietary, drinking
water, dermal, or oral exposures. The document consists of six sections. Section I is the
introduction. Section II describes EPTC, its uses, data requirements, and regulatory history. Section
III discusses the human health and environmental assessment, based on the data available to the
Agency. Section IV presents the reregistration decision for EPTC. Section V discusses the
reregistration requirements for EPTC. Finally, Section VI is the Appendices which support this RED.
Additional details concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Document:
• Common Name: EPTC
• Chemical Name: S-Ethyl dipropylthiocarbamate
• Chemical Family: Thiocarbamate
• Type of Chemical: Herbicide
CAS Registry Number: 759-94-4
OPP Chemical Code: 041401
• Empirical Formula: C9H19NOS
• Basic Manufacturer: Zeneca Ag Products
B. Use Profile
EPTC is a pre-emergence and early post-emergence thiocarbamate herbicide used to control
the growth of germinating annual weeds, including broadleaves, grasses, and sedges. It is used in
every region of the United States in the agricultural production of a wide variety of food crops. The
heaviest usage is in the Corn Belt, Northeastern and Mid-Atlantic states, Coastal and Northern Great
Plains and in the Pacific Northwest. Flighest use states are California, Michigan, Oregon,
Pennsylvania, North Dakota, Minnesota, and Arizona. The largest markets in terms of total pounds
of active ingredient are corn, potatoes, dry beans, peas, alfalfa, and snap beans. Usage ranges from
about 10 to 20 million pounds a.i. annually. EPTC is also available to the residential home gardener
for use in vegetable and ornamental gardens.
As with other thiocarbamate herbicides, EPTC exerts its herbicidal action through inhibition
of cuticle formation at the early stages of seedling growth. Formulated products include emulsifiable
concentrate (EC) liquids containing up to 87.8% active ingredient and granular (G) formulations
containing up to 25% active ingredient. EPTC is typically applied annually in a single or three
application process, with each application ranging from about 2 to 6.1 Ibs a.i./acre (max rate 7.5 to
12.2 Ibs a.i./acre for alfalfa and potatoes). EPTC can either be applied by ground equipment or
through irrigation. Because of its chemical properties, however it is applied, it must be incorporated
into the soil immediately after application to prevent volatilization.
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The following is information on the types of formulations registered with an overview of use
sites and application methods:
Types of Products % A..I.
EMULSIFIABLE CONCENTRATE 67.8 to 76.9%
MANUFACTURING PRODUCT
EMULSIFIABLE CONCENTRATE 87.8%
END USE PRODUCT
EMULSIFIABLE CONCENTRATE 72.2 to 87.8%
[72.2%, 73.4%, 74.4%,
75.2%, 76.97%, 82.6%,
87.27%, 87.80%]
GRANULAR 02.3 to 25.0%
[2.3%, 5.0%, 10.0%,
20.0%, 25.0%]
SOLUBLE CONCENTRATE/LIQUID 92.9%
TECHNICAL GRADE/END USE 98.5%
Table 1. Use sites for EPTC
Food use sites Non-food use sites Residential/public use sites
Alfalfa Citrus nursery stock Parks
Almonds Non-bearing Orange Orchards Ornamentals
Beans Non-bearing grapefruit Shade trees
Birdsfoot trefoil Evergreens Evergreens
Citrus Deciduous trees Flower Gardens
Clover Scrubs Aquatics (Drainage Systems)
Corn (field and sweet) Pine seedling nurseries Turf (Ornamental)
Cotton Ornamentals (plant, flowers) Golf Course Sand traps
Garden beets
Lespedeza
Potatoes
Safflower
Sunflower
Sugar beets
Sweet Potatoes
Tomatoes
Walnuts
C. Methods and Rates of Application and Target Weeds
EPTC may be broadcast using aerial equipment to apply premix granulars, ground boom to
spray the premixed chemical, or applied through chemigation. EPTC is highly volatile, and must be
soil incorporated either as soon as possible after application with ground equipment or through
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irrigation to effectively control weed germination. EPTC is applied primarily as a pre-plant herbicide,
but applications are also made post-plant, postemergence, and as fall fallow treatments. Other types
of treatment include band treatment and soil sidedress treatment.
Labels recommend that soil incorporation occur at the same time as application, a couple of
hours after application, or in the case of arid areas, such as eastern Oregon, within 36 hours.
According to EPTC labels, application rates on agricultural crops range from a minimum of 1.5 to
7.4 Ibs a.i./A on sweet potatoes. Application rates frequently range from 2.0 to 4.0 Ibs a.i./A for most
crops. However, application rates of 6.1 Ibs. a.i./A are registered for use on beans, corn, non-bearing
citrus, Irish potatoes, and fallow land. Labels for most uses do not indicate whether multiple
applications are permitted and what maximum annual poundages are permitted, but will have to be
corrected on the reregistered labels. The highest number of applications identified on a label is 4
applications on alfalfa. The maximum annual poundage limitation on labels is 15 Ibs. a.i./A for use
on ornamentals.
Types of Treatment
Band treatment, Broadcast, Chemigation, Directed spray, Soil band treatment, Soil broadcast
treatment, Soil incorporated treatment, Soil injection treatment, Soil sidedress treatment, Soil
treatment, Spray.
Equipment
Aircraft, By hand, Granule applicator, Gravity irrigation, Low pressure ground sprayer,
Injection equipment, Irrigation, Package applicator, Soil incorporation equipment, Soil injector
equipment, Sprayer, Spreader, Sprinkler irrigation.
Timing
At planting; Bearing; Bloom; Early postemergence; Early spring; Established plantings; Fall;
Foliar; Fruiting; June; Late fall; Late summer; Layby; Nonbearing; Nursery stock; Plant bed;
Post-thinning; Postemergence; Post-plant; Post-transplant; Pre-bedding; Pre-bloom; Pre-emergence;
Pre-plant; Preplant (Fall); Preplant (Spring); Pretransplant; Seed Crop; Spring; When needed.
Target Weeds
BROADLEAVES: annual morningglory, black nightshade, carpetweed, chrysanthemum
weed, common chickweed, common lambsquarters, common purslane, common ragweed, corn
spurry, cutleaf evening primrose, cutleaf nightshade, dead nettle, fiddleneck, Florida pusley, hairy
nightshade, henbit, lambsquarters, mugwort, nettleleaf goosefoot, prickly sida, prostrate pigweed,
puncturevine, redroot pigweed, shepherds purse, sicklepod, smartweed, tall morningglory, tumble
pigweed, velvetleaf
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GRASSES: annual bluegrass, annual ryegrass, barley (volunteer), barnyard grass, bermuda
grass, bermuda grass (seedling), crabgrass, echinochloa, fall panicum, field sandbur, giant foxtail,
goosegrass, green foxtail, Johnson grass (seedling), junglerice, Italian ryegrass, love grass, oat
(volunteer), quackgrass, red rice rescue grass, shattercane, signalgrass, stinkgrass, tall fescue, Texas
panicum, yellow foxtail, watergrass, wheat (volunteer), wild proso millet, wild oat, witchgrass, wooly
cupgrass; SEDGES: purple nutsedge, yellow nutsedge.
D. Estimated Usage of Pesticide
Table 2 summarizes the best available estimates of EPTC use. These estimates are derived
from a variety of published and proprietary sources available to the Agency. The data, reported on
an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the variability
in using data from various information sources.
Based on available pesticide survey usage information for the years of 1987 through 1996,
an annual estimate of EPTC total domestic usage averaged approximately 20 million pounds a.i. for
almost 6 million acres treated. EPTC is a broad spectrum herbicide with its largest markets in terms
of total pounds a.i. allocated to corn (56%), corn continuous (13%), dry beans/peas (8%),and
potatoes (6%). Most of the usage is in CA, MI, OR, PA, ND, MN, AZ, SC, NC, AR, MT, IL, NE,
LA, TX, KY, TN, AND CO.
Crops with the highest percentage of total U.S. planted acres treated with EPTC include
processed snap beans (59%), dry beans (32%), dry peas (29%), potatoes (25%), green peas (21%).
Table 2. Estimated
Site
Alfalfa
Almonds
Apples
Barley
Beans, Dry
Beans, Snap,
Fresh
Beans, Snap,
Proc.
Peas/Dry
Peas, Green
Beets
Acres
Grown
(000)
23,949
429
572
7,505
1,802
81
228
2,181
723
12
percentage of EPTC Treated Acres
Acres Treated
(000)
Wtd
Avg
146.9
7.3
0.7
3.3
574.3
5.9
135.6
637.9
148.4
0.04
Est
Max
293.9
14.6
1.5
14.0
794.7
9.5
184.2
837.3
209.4
0.6
% of Crop Treated
Wtd
Avg
0.6%
1.7%
0.1%
0.04%
32%
7.3%
59.4%
29 2%
20.5%
0.4%
Est
Max
1.2%
3.4%
0.3%
0.2%
44%
12%
81%
38%
29%
4.8%
LB a.i. Applied
(000)
Wtd
Avg
490
19
3
8
430
14
450
1,520
470
0.1
Est
Max
970
39
7
26
866
23
608
2,156
626
0
Average Application Rate
Ib a.i.
acre/yr
3.3
2.6
4.8
2.4
0.7
2.4
3.3
2.4
3.2
3.0
#appl
/yr
1.4
1.2
2 2
1.1
1.0
1.0
1.0
1.0
1.0
1.0
Ib a.i.
A/appl
2.3
2.2
2 2
2.2
0.7
2.3
3.3
2.3
3.1
3.0
States of
Most Usage
(% of total Ib
a.i. used
on this site)
CA WI WA AZ
MN NY 72%
CA 100%
WA 82%
NDID91%
NE MI ID CO
NY 85%
FLNY81%
WI OR 87%
MI NE CO ID
WA 82%
WI OR NY MI
FL 82%
CA 100%
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Site
Berries
Cherries
Cole Crops
Corn
Corn Continuous
Cotton
Cucurbits
Flax
Hay, Other
Idle Cropland
Lemons
Lettuce
Lots/Farmsteads
/etc
Melons
Oats/Rye
Oranges
Other Crops
Peaches
Peanuts
Pecans
Potatoes
Rice
Roots/
Tubers
Seed Crops
Seaside Acres
Sorghum
Soybeans
Sugar Beets
Sugarcane
Acres
Grown
(000)
161
128
313
72,284
27,111
12,689
285
188
33,427
7,461
63
268
24,815
368
6,133
867
2,515
212
1,610
488
1,421
2,921
244
1,516
21,802
11,280
62,879
1,415
852
Acres Treated
(000)
Wtd
Avg
0.1
0.1
0.02
2,664
629
4.2
0.1
0.8
5.2
1.8
0.4
1.5
0.5
0.2
0.4
0.3
151.9
0.2
0.3
0.02
358.0
0.1
1.2
35.3
2.0
0.1
13.6
149.9
2.5
Est
Max
3.3
0.2
0.03
5,328
1,259
8.4
0.3
2.0
16.5
151.6
0.8
3.0
1.0
0.4
2.5
0.6
284.8
1.3
1.6
0.04
439.7
0.2
6.5
129.8
4.0
0.2
42.0
273.0
11.5
% of Crop Treated
Wtd
Avg
0.04%
0.04%
0.01%
3.7%
2.3%
0.03%
0.04%
0.4%
0.02%
0.02%
0.6%
0.6%
0.002%
0.1%
0.01%
0.04%
6.0%
0.1%
0.02%
0.004%
25.2%
0.004%
0.5%
2.3%
0.01%
0.001%
0.02%
10.6%
0.3%
Est
Max
2.1%
0.2%
0.01%
7.4%
4.6%
0.1%
0.1%
1.1%
0.05%
2.0%
1.2%
1.1%
0.004%
0.1%
0.04%
0.1%
11.3%
0.6%
0.1%
0.01%
30.9%
0.01%
2.7%
8.6%
0.02%
0.002%
0.1%
19.3%
1.4%
LB a.i. Applied
(000)
Wtd
Avg
0.3
0.1
0.1
11,070
2,560
16
0.3
3
77
6
1
8
2
1
1
3
320
0.4
1
0.1
1,190
1
0
97
6
0
37
290
10
Est
Max
13
0.2
0.2
22,136
5,116
32
1
14
78
466
3
16
4
2
3
5
617
0
7
0.2
2,251
2
12
357
16
1
73
599
46
Average Application Rate
Ib a.i.
acre/yr
4.0
1.0
1.0
4.2
4.1
3.8
2.9
3.3
4.2
3.1
3.7
5.4
4.3
3.7
1.7
8.5
2.1
1.7
4.5
1.0
3.3
9.5
1.8
2.7
3.0
2.5
2.7
1.9
4.0
#appl
/yr
1.0
1.0
1.0
1.1
1.0
2.2
1.0
1.0
1.0
1.0
2.2
1.0
1.4
1.0
1.0
3.5
1.0
1.0
1.0
1.0
1.0
1.5
1.3
1.0
1.0
1.0
1.1
1.0
1.0
Ib a.i.
A/appl
4.0
1.0
1.0
3.9
4.0
1.7
2.9
3.3
4.2
3.1
1.7
5.4
3.1
3.7
1.7
2.4
2.0
1.7
4.5
1.0
3.3
6.3
1.4
2.7
3.0
2.5
2.6
1.9
4.0
States of
Most Usage
(% of total Ib
a.i. used
on this site)
MI 100%
OR 100%
PA 100%
MN IA IL SD
ND WI 80%
IAMNWIIL
NEKS 61%
AZ 92%
MI 86%
NDMN100%
OK TX ID IL
82%
CA MI 98%
AZ 100%
AZ 100%
OR IA WI LA
88%
CAMI100%
MN88%
AZ 98%
MN CA LA ID
MT 83%
CASC100%
NCI 00%
CA 100%
ID CO WA CA
OR 80%
AR 100%
CA MI OR 92%
MT IL OR 95%
NY UT CA SD
NE 80%
NE 100%
MNNCNEND
TN WY 70%
MN CA ID 82%
LA 100%
-------
Site
Summer Fallow
Sunflower
Sweet Corn,
Fresh
Sweet Corn,
Proc.
Sweet Potatoes
Tobacco
Tomatoes
Vegetables,
Bulb
Vegetables,
Other
Walnuts
Wheat, Spring
Wheat, Winter
Total
Acres
Grown
(000)
29,040
2,745
233
544
85
695
500
198
286
205
20,799
45,854
Acres Treated
(000)
Wtd
Avg
5.8
9.1
1.0
51.9
0.8
0.0
36.0
2.5
140.7
1.8
7.0
8.6
5,950
Est
Max
880.7
21.0
6.0
79.5
5.0
0.0
74.7
8.0
240.8
3.3
18.0
26.8
8,823
% of Crop Treated
Wtd
Avg
0.02%
0.3%
0.4%
9.5%
1.0%
0.002%
7.2%
1.3%
49.2%
0.9%
0.03%
0.02%
Est
Max
3.0%
0.8%
2.6%
14.6%
6.0%
0.004%
14.9%
4.0%
84.2%
1.46%
0.1%
0.1%
LB a.i. Applied
(000)
Wtd
Avg
18
33
8
230
2
0.1
83
5
400
5
12
21
19,869
Est
Max
2,690
83
48
347
15
0.2
199
15
700
9
48
76
30,647
Average Application Rate
Ib a.i.
acre/yr
3.1
3.6
7.9
4.4
3.0
6.0
2.3
1.9
2.8
2.9
1.7
2.5
#appl
/yr
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.1
1.0
Ib a.i.
A/appl
3.1
3.6
7.9
4.4
3.0
6.0
2.3
1.9
2.8
2.8
1.5
2.5
States of
Most Usage
(% of total Ib
a.i. used
on this site)
CA TX 99%
ND OH WI SD
PA 85%
81%
WIMNOR
90%
TX 100%
KYTN100%
CA 96%
OR CO 100%
WI OR NY MI
AZFL81%
CA 100%
ID CO ND 94%
OR NC NY 85%
COLUMN HEADINGS
Wtd Avg = Weighted average-the most recent years and more reliable data are weighted more heavily.
Est Max = Estimated maximum, which is estimated from available data.
Average application rates are calculated from the weighted averages
NOTES ON TABLE DATA
Usage data primarily covers 1987-1996. Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest
1000 for acres treated or Ib. a.i. (Therefore 0 = < 500) to the nearest whole percentage point for % of crop treated. (Therefore 0% = <0.5%)
0* = Available EPA sources indicate that no usage is observed in the reported data for this site,
which implies that there is little or no usage.
A dash (-) indicates that information on this site is NOT available in EPA sources or is insufficient.
* Other/Crop Groups
Cole Crops includes broccoli, Brussels sprouts, cabbage, cauliflower, mustard greens, collards, bok choy, and chard.
Cucurbits includes cucumber, squash, and pumpkin. Melons include cantaloupe, watermelon, honeydew, muskmelon, and winter melon.
Root and Tuber Crops include red beets, carrots, horseradish, parsnips, radish, rutabagas, sweet potatoes, turnips, and yams.
Vegetables, Other includes, artichokes, asparagus, okra, oriental vegetables, rhubarb, and truck garden.
Other Crops include ornamentals, popcorn, rapeseed/canola, and safflower.
Vegetable, bulb includes onions, leeks, and garlic.
SOURCES: EPA data (1987-96), USDA/NASS (1990-96), and National Center for Food and Agricultural Policy, 1992.
E. Data Requirements
The Agency requires the registrant to submit additional confirmatory studies as specified in
40 CFR Section 158. Data from these studies are necessary to further characterize the risks
associated with the uses described in this document and to confirm assumptions made in estimating
risks. Refer to section IV of this document for a complete list.
7
-------
F. Regulatory History
EPTC was registered in the United States in 1958 for use as a selective preemergent
herbicide, and was originally owned by Stauffer Chemical Company. Chemiolimpex, a technical
EPTC (TGAI), was manufactured in Hungary, and was imported into the United States by PPG
Industries of Pittsburgh, Pennsylvania. Zeneca Ag Products currently holds registrations for several
end-use products, and holds the only registration for the technical product.
A Registration Standard for the EPTC was issued in September 1983. The Agency determined
that additional generic data would have to be submitted for evaluation in order to maintain
registration. This RED reflects a reassessment of all data which were submitted in response to the
Registration Standard.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Chemical Profile
EPTC is the common name and Eptam is the Trade name for S-Ethyl di propyl thiocarbamate.
The empirical formula of EPTC is C9H19NOS and the chemical structure is shown in the figure
below. Other thiocarbamate herbicides include tri-alate, di-alate, vernolate, pebulate, molinate,
butylate, and cycloate.
o
N
.CH,
Selected physical and chemical properties of EPTC are presented in the table below. When
more than one value was available, it is presented to provided an indication of the range and
variability under different temperatures, different formulations, or from different studies
(or sources).
-------
Table 3. Selected Physical and Chemical Properties of EPTC.
Property
Empirical Formula
Molecular Weight
Density (Pure Active Ingredient, PAI)
(Technical Grade A.I., TGAI)
Aqueous Solubility
PAI
Vapor Pressure
Dissociation Constant
Octanol/Water Partition coefficient (PAI)
Henry's Law Constant
Value
C^NOS1
189.321
0.9633 g/mL1
0.9639 g/mL1
344 + 5 ppm @25'°C1
344 ppm1
370 ppm @20°C2
2.4 x 10'2 mm Hg @25°C1
1.60xlO-2mmHg@20°C2
not applicable
Kow:2.2xl03 + 0.1xl03@25°C
orLogKow: 3.341
1.7 x 10'5 m3 - atm/g-mol @25°C1
2.29 x 10'5 m3 - atm/g-mol @25°C2
6.25 x 10'4 (unitless)
1 MRID 42120801
2 EFED One-liner Database (11/15/94)
Possible soil and water degradates including EPTC sulfoxide (ESO), EPTC sulfone, N,N-
dipropylformamide, dipropylamine, and ethanesulfonic acid were identified in a photolysis study. In
terrestrial field dissipation studies only two degradates were detected in soil samples: ESO, and di-N-
propylamine. Only ESO was identified in an aerobic soil metabolism study.
2. Environmental Fate Summary
The environmental fate data base is incomplete, but is sufficient to allow for an environmental
fate assessment of parent EPTC that generally fits the pattern suggested by the monitoring data which
are available.
Soil metabolism and volatilization from soil are the most important dissipation pathways, for
EPTC in the environment. EPTC does not appear to be persistent under most conditions, but where
microbial degradation is inhibited or volatilization is restricted EPTC could be persistent. EPTC is
highly volatile (vapor pressure 1.60 x 10"2 mm Hg @20°C, Henry's Law Constant -1.7 x 10-5 m3 -
atm/g-mol @ 25°C).
B.
Human Health Assessment
1. Toxicology Assessment
Cardiomyopathy and neuronal cell necrosis were observed in studies of varying length of
treatment and in different species using EPTC. EPTC did not produce any significant reproductive
and developmental toxicity, and was negative in two oncogenicity studies.
-------
EPTC is a reversible inhibitor of Cholinesterase (ChE). Toxicology studies with EPTC did
not show any consistent pattern of ChE inhibition among different species, lengths of treatment, or
the type of ChE enzyme measured. Inhibition of plasma ChE with dose-related increases in red blood
cells and brain ChE inhibition are the typically expected results. In some studies, brain ChE activity
was inhibited without any effect on either plasma or erythrocyte ChE activities. In other studies,
erythrocyte ChE was inhibited with no inhibition of either plasma or brain ChE. Two studies which
yielded commonly expected results were a chronic dog oral dosing (capsule), study in which plasma
only was ChE inhibited, and a rabbit developmental study, in which plasma and erythrocyte ChE
were inhibited. As a class of compounds, thiocarbamates do not produce consistent ChE inhibition
profiles. A study with rats measured the inhibition of ChE by EPTC and other thiocarbamates-
cycloate, butylate, pebulate, or vernolate at doses at or near the acute median lethal doses. While
vernolate, pebulate and cycloate inhibited plasma, erythrocyte, and brain ChE to varying degrees,
butylate inhibited plasma ChE only, and EPTC inhibited only erythrocyte and brain ChE, but not
plasma ChE.
Cardiotoxicity was observed in subchronic and long-term studies, and, in general, the severity
and incidence of the lesion increased with increasing dose of EPTC. In 90-day feeding and inhalation
studies and in two chronic feeding/oncogenicity studies, all in rats histopathological evaluations
revealed myocardial degeneration. Additional studies in rats, revealed myocardial degeneration in
adult animals in two separate two-generation reproduction studies. In two chronic oral dosing studies
in the dog, degenerative changes in the cardiac muscle were observed when EPTC was administered
in a capsule, but not when administered at comparable doses in the diet. In both of the dog studies,
electrocardiograms were taken, but only one high-dose male in the capsule study had changes which
were described as "potentially" treatment-related.
EPTC, as well as other thiocarbamates (molinate, cycloate, pebulate, vernolate, and butylate),
has toxic effects on the central and peripheral nervous systems. With EPTC, there was an increased
incidence and severity of neuronal necrosis/degeneration in both the central and peripheral nervous
systems in rats and dogs. In the neurotoxicity studies in rats, dose-related increases in the incidence
of neuronal necrosis were observed in the brains after acute and subchronic exposure to EPTC. The
acute delayed neurotoxicity study in hens, however, did not reveal any delayed neurotoxicity. In both
combined chronic toxicity/oncogenicity studies in rats and in the chronic (capsule) study in dogs,
treatment-related neuromuscular lesions were observed. In all of these studies, hindquarter weakness
was observed, and at necropsy evaluation, atrophy and degeneration of the skeletal muscle was
observed. In the dog study, the lesions were described as Wallerian-type degeneration in the spinal
cords and various peripheral nerves.
Because of the neurotoxic effects (neuronal necrosis/degeneration), the Hazard Identification
Assessment Review Committee (HIARC) recommended that a developmental neurotoxicity study
in the rat be performed, and recommended that the 10X uncertainty factor, as required by FQPA, be
retained.
10
-------
a. Acute Toxicity
Results of acute toxicity, primary eye and dermal irritation, and dermal sensitization studies
with EPTC technical material are summarized in the following table. EPTC is moderately toxic
(Toxicity Category III) via the oral and dermal routes, and in a primary eye irritation study in rabbits,
the technical was found to be slightly irritating (Toxicity Category III). EPTC is most toxic via the
inhalation route (Toxicity Category II).
Table 4. Acute Toxicity of EPTC Technical Material
Study Type
81-1: Acute Oral
81-2: Acute Dermal
81-3: Acute Inhalation
81-4: Primary Eye Irritation
81-5: Primary Dermal Irritation
81-6: Dermal Sensitization
Animal
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD50 Male 1465 (1290-1663) mg/kg
Female 1712 (1324-2214) mg/kg
Combined 1599 (1294-1976) mg/kg
LD50 Male > 2000 mg/kg
Female > 2000 mg/kg
LC50 Combined 1.39 (0.97-2.00) ppm
PIS (24hr) = 2.2
Reversed within 3 days
PII = 1.4
Very slight sensitizer
Weak sensitizer (Magnus son-Kligman)
Tox Cat
III
III
II
III
IV
N/A
N/A
MRID No
00 157868
00 157869
00 157870
00 157871
00 157872
00 157873
41709201
The acute toxicity category, listed above, are for informational purposes only. The data
supporting these category may or may not meet current acceptability criteria. The acceptability
status of these data may be reassessed during product reregistration.
b. Chronic Toxicity/Carcinogenicity
EPTC is not carcinogenic. Oncogenicity studies in both rat and mice did not indicate that
exposure to EPTC resulted in an increased incidence of neoplastic lesions. This is supported by lack
of a carcinogenic effect in other long-term studies and no genetic component in reproduction and
developmental studies.
c. Developmental & Reproductive Toxicity
The developmental and reproductive toxicity of EPTC was evaluated. Studies in rat and
rabbits showed developmental and reproductive toxicity only in the presence of maternal or parental
toxicity. In a prenatal developmental toxicity study in rats, developmental toxicity (in part, decreased
fetal body weight and decreased litter size, but effects were attributed to maternal stress) was seen
in the presence of marked maternal toxicity (increased mortality and decreased body weight). In a
developmental toxicity study in rabbits, developmental toxicity (decreased fetal body weight) was
again seen in the presence of marked maternal toxicity (in part, decreased body weight and increased
mortality).
11
-------
In a two-generation reproduction study in rats, effects in the offspring were observed only at
or above treatment levels which resulted in parental toxicity. However, even though there does not
appear to be any concern about the reproductive or developmental toxicity of EPIC, based on
studies available, the neurotoxic effects (neuronal necrosis and degeneration) warrant the need for
a developmental neurotoxicity study, and therefore the retention of the 10X safety factor, as required
by the Food Quality Protection Act (FQPA).
d. Mutagenicity
EPTC has intrinsic genotoxicity which was not expressed in either the in vivo micro nucleus
test or the Drosophila sex-linked recessive lethal mutation assay.
e. Dermal Absorption
In dermal absorption studies with EPTC and other thiocarbamates, EPTC was found to
rapidly evaporate (volatilize) from warm skin. Based on a dermal absorption study in the rat which
utilized a charcoal impregnated filter to capture vapors lost from the skin, absorption of EPTC was
determined to be 5% at 10 hours.
f. Metabolism
The metabolism of EPTC was evaluated in rats using 14C-labeled EPTC. EPTC was rapidly
absorbed and excreted; there was very little bioaccumulation. Most of the radioactivity appeared in
urine, with markedly lower amounts in the feces and exhaled air. No sex differences were noted in
the absorption, tissue distribution, and excretion of EPTC.
g. Other Toxicological Endpoints
Endocrine Disrupter Effects
FQPA requires EPA to develop a screening program to determine whether certain substances
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced
by a naturally occurring estrogen, or such other endocrine effect...". EPA has been working with
interested stakeholders, including other government agencies, public interest groups, industry, and
research scientists, to develop a screening and testing program as well as a priority setting scheme
to implement this program. The Agency's proposed Endocrine Disrupter Screening Program was
published in the Federal Register of December 28, 1998 (63 FR 71541). The Program uses a tiered
approach and anticipates issuing a Priority List of chemicals and mixtures for Tier 1 screening in the
year 2000. As the Agency proceeds with implementation of this program, further testing of EPTC
and end-use products for endocrine effects may be required.
12
-------
2. Dose Response Assessment
a. FQPA Considerations
The Agency's FQPA Safety Factor Committee met on November 2, 1998 to evaluate the
hazard and exposure data for EPTC and recommended that the FQPA Safety Factor (as required by
Food Quality Protection Act of August 3, 1996) be retained in assessing the risk posed by this
chemical due to concern for:
A data gap for a developmental neurotoxicity study in rats which was identified by the
HIARC. A developmental neurotoxicity study will provide additional data regarding
functional parameter development, potential increased susceptibility, and the effects of EPTC
on the development of the fetal nervous system.
The requirement for a developmental neurotoxicity study is supported by the following:
the severe neuropathology exhibited in acute, subchronic, and chronic studies with adult
animals (acute, subchronic, and chronic exposure to EPTC produced neuronal cell necrosis
of the brain in adult rats and dogs; and axonal degeneration of the spinal cord in the adult rat);
the structure activity relationship to molinate and other thiocarbamates known to produce
neurotoxicity/neuropathology; molinate induces neurotoxicity/neuropathology after single and
multiple exposures via the oral, dermal, and inhalation routes across species. There is clear
evidence of increased susceptibility in rat fetuses following in utero exposure to molinate in
the prenatal developmental study. Increased susceptibility was demonstrated in the
developmental neurotoxicity study in rats. Molinate was also found to be a reproductive
toxicant (mice, rats, and dogs);
The Committee determined that the lOx FQPA safety factor is applicable for the following
subpopulations:
Acute Dietary Assessment: All populations which include infants and children. The FQPA
factor is appropriate for these populations due to the uncertainly regarding the effects on the
developing fetal nervous system after a single exposure to EPTC. This uncertainty is also being
addressed by the requirement of a developmental neurotoxicity study in rats.
Chronic Dietary Assessment: All populations which include infants and children. The FQPA
factor is appropriate for these populations due to the uncertainty regarding the effects on the
developing fetal nervous system after repeated exposures to EPTC. This uncertainty is being
addressed by the requirement of a developmental neurotoxicity study in rats.
Residential (Short-. Intermediate- and/or Long-Term) Assessment(s): All populations which
include Infants and Children. The FQPA factor is appropriate for these populations since the
potential for residential exposure to infants and children resulting from the use of EPTC exists and
13
-------
there is uncertainty regarding the effects on the developing fetal nervous system after such exposure.
Again, this uncertainty is being addressed by the requirement of a developmental neurotoxicity study
in rats.
b. Cancer Classification
EPTC is not carcinogenic. Oncogenicity studies in both the rat and mouse did not indicate
that exposure to EPTC resulted in an increased incidence of neoplastic lesions. EPTC has intrinsic
genotoxicity which was not expressed in either the in vivo micro nucleus test or the Drosophila sex-
linked recessive lethal mutation assay. This is supported by lack of a carcinogenic effect in long-term
studies, and no genetic component in reproduction and developmental studies.
c. Reference Dose and Toxicological Endpoints
On September 17, 1998, the Agency's Hazard Identification Assessment Review Committee
(HIARC) evaluated the toxicological endpoints selected for acute and chronic dietary, as well as for
occupational and residential (dermal and inhalation) exposure risk assessments for EPTC. On July
29, 1999, the HIARC reconsidered the short and intermediate-term inhalation endpoints selected for
occupational and residential risk assessments based on the re-evaluation of the 90-day inhalation
toxicity study in rats. The doses and toxicological endpoints selected for various exposure scenarios
are summarized in the following table.
The Reference Dose (RfD) is derived from an exposure level at which there are no statistically
or biologically significant increases in the frequency or severity of adverse effects between the
exposed population and its appropriate control, along with the application of uncertainty factors. The
percent of the RfD is calculated as the ratio of the exposure value to the RfD (exposure/RfD x 100
= % RfD).
14
-------
Table 5. Summary of Doses and Endpoints Selected for EPTC Risk Assessments
EXPOSURE
SCENARIO
Acute Dietary
Chronic Dietary
Carcinogenicity
(Dietary)
Short-Term (Dermal) a
Intermediate-term
(Dermal)
Long-Term (Dermal)
Inhalation
(Short Term)
Inhalation
(Intermediate Term less than
21 days)
Inhalation
(Intermediate Term greater
than 21 days)
Long-Term (Inhalation)
DOSE
(mg/kg/day)
LOAEL=200 (LOT)
UF=300(10x,10x,3xfor lack
ofNOAEL)
FQPA Safety Factor Retained
(lOx)
NOAEL=2.5
UF=100 (10X10)
FQPA Safety Factor Retained
(lOx)
ENDPOINT
Neuronal necrosis in the brain
STUDY
Acute Neurotoxicity in
Rat
Acute RfD = 0.67 mg/kg/day
Acute PAD = 0.067 mg/kg/day
Parental toxicity, dose-related increase in
degenerative cardiomyopathy
Two-Generation
Reproduction Study in
Rat
Chronic RfD = 0.025 mg/kg/day
Chronic PAD = 0.0025mg/kg/day
Not required. EPTC was not mutagenic and did not exhibit any oncogenic potential in a mouse
oncogenicity
study, and two combined chronic toxicity/oncogenicity studies in rat.
Oral LOAEL=200
Neuronal necrosis in the brain.
Acute Neurotoxicity in
Rat
UF = 300 (lOx, lOx, 3x for lack of a NOEL) (5.0% dermal absorption)
UF = 3000 for all non-occupational residential populations which include infants and children (FQPA
Safety
Factor Retained (lOx)
Oral NOAEL = 9
Decreased body weight and relative brain
weight and neuronal necrosis
90-Day Neurotoxicity
Study in Rat
UF = 100 (10x10) (5.0% dermal absorption)
The use pattern does not indicate the need for long-term dermal risk assessment.
NOAEL 58 ,ug/L
Myocardial degeneration observed at 21 days
in a 90-day inhalation study
90-day Inhalation Study
in Rat
UF = 100 (10x10 )(100% inhalation absorption); UF = 1000 for all non-occupational populations
NOAEL 58 ,ug/L
Myocardial degeneration observed at 21 days
in a 90-day inhalation study
90-day Inhalation Study
in Rat
UF = 100 (10x10) (100% inhalation absorption); UF = 1000 for all non-occupational populations
NOAEL = 8.3 ^g/L
Clinical signs, decreased food consumption,
brain ChEI in males, and increased
prothrombin times in females.
90-day Inhalation Study
in Rat
UF = 100 (10x10) (100% inhalation absorption); UF = 1000 for all non-occupational populations (FQPA
Safety
Factor Retained) (lOx)
The use pattern does not indicate the need for long-term inhalation risk assessment.
a = The use of a 5% dermal absorption rate is required for dermal risk assessments.
15
-------
The population adjusted dose (PAD) is an adjusted RfD reflecting the retention or reduction
of the FQPA safety factor for all populations which include infants and children. For EPIC, the acute
population adjusted dose (aPAD) and chronic population adjusted dose (cPAD) is 0.067 mg/kg/day
and 0.0025 mg/kg/day, respectively.
Because different toxic effects were observed for dermal and inhalation dose routes, a
separate margin of exposure (MOE) will be used for dermal and inhalation risk assessments.
For the short, intermediate and long term dermal, as-well-as short, intermediate and long term
inhalation, the FQPA lOx safety factor was retained for non-occupational, but not occupational
handlers.
3. Exposure Assessment
a. Dietary Exposure
In plants, EPTC is metabolized to a variety of products via several different metabolic
pathways. The major metabolic pathway of EPTC involves initial oxidation of the sulfur atom to a
sulfoxide, which is oxidized further to a sulfone. The sulfone metabolite is then conjugated with
glutathione and the resultant glutathione conjugate is sequentially metabolized to the following
cysteine; N-malonyl cysteine; S-lactic acid; and O-malonyl-S-lactic acid-conjugates: The second
metabolic pathway of EPTC is hydroxylation of the alkyl yielding the following: N-(2-
hydroxy)propyl-N-(3-hydroxy)propyl-and S-(2-hydroxy)ethyl-metabolites.
The Agency has concluded that the EPTC plant residues of toxicological concern are: EPTC,
EPTC sulfoxide; EPTC sulfone; and the EPTC conjugates (i.e. glutathione-; cysteine-N-malonyl
cysteine-S-lactic acid, and O-malonyl-S-lactic acid-conjugates). The basis for the toxicological
concern of these substances is the presence of the thiocarbamate moiety. The hydroxylated EPTC
plant metabolites also contain the thiocarbamate moiety. However, these metabolites are formed only
in low concentrations and, as such, the Agency believes these residues do not contribute significantly
to the total toxicity of EPTC.
Because of the diverse structural and physiocochemical differences between these compounds,
the Agency concurred with the registrant's position that development of a single enforcement
analytical method that can detect each of these residues was not feasible. Because development of
an enforcement analytical method for the hydroxylated metabolites was feasible, the Agency
concurred with the registrant's recommendation that EPTC and its hydroxylated metabolites be used
as marker residues of EPTC residues of toxicological concern (i.e., markers of EPTC, EPTC
sulfoxide, EPTC sulfone, and the EPTC conjugates resulting from the glutathione-S-transferase
pathway).
Therefore, tolerances for EPTC residues in or on plants represent the presence of EPTC and
its hydroxylated metabolites (free or conjugated). The ratio formed in plants of EPTC residues of
16
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toxicological concern to EPTC residues that will be used as markers varies from 1.5:1 (potatoes) to
13.2:1 (bean vines). The Agency decided that, for purposes of assessing the risks posed by EPTC,
the concentration of any marker compound residues will be multiplied by 15 to estimate the
concentration of residues of concern. This factor was selected to cover the high-end of the range of
metabolite ratios. The tolerance expression, therefore, will now consist of residues of EPTC per se
and the EPTC hydroxylated metabolites mentioned above. Hence, all EPTC tolerances have been
reassessed based on residue data for the combined residues of EPTC and its hydroxylated metabolites.
For the determination of residues of EPTC per se in or on plant commodities, the Pesticide
Analytical Manual (PAM, Vol. II, Section 180.117) lists Methods A (GLC/MC (micro colorimetric)
Method RR-50; level of detection (LOD) = 0.02-0.04 ppm, depending on the matrix) and B (a
confirmatory colorimetric procedure). The EPTC Reregistration Standard Guidance Document of
1983 concluded that the GLC/MC method is adequate for data collection and corresponding
tolerance enforcement. Hence, an enforcement analytical method for detecting EPTC per se is
available.
For the determination of hydroxylated metabolites (free or conjugated) of EPTC in or on
plant commodities, the registrant has proposed a GC/NPD method as an enforcement method. (The
level of quantification (LOQ) of each hydroxylated metabolite is 0.01 ppm.) The registrant recently
submitted to the Agency a description of the proposed method, along with preliminary recovery data.
The proposed method was reviewed by the Agency, and determined to be adequate. The Agency has
required an independent laboratory validation (ILV) of the proposed method in accordance with PR
Notice 96-1. When a successful ILV has been received and evaluated, an Agency method trial will
be conducted at the EPA Analytical Chemistry Laboratory.
For purposes of tolerance enforcement in accordance with the revised tolerance expression
(the combined residues of EPTC and its hydroxylated metabolites as markers), confirmatory data
are required to validate the proposed enforcement method for determination of the hydroxylated
metabolites. An enforcement analytical method for EPTC is currently available. The Agency believes
that field trial consistently demonstrate that residues of EPTC and the hydroxylated metabolites
present on treated commodities are non-detectable. The existing enforcement method for the parent
will be revised when the new method is available.
In animals, only a single EPTC residue of toxicological concern was found, in goats, (EPTC-
cysteine conjugate) and hens (unmetabolized EPTC) fed highly exaggerated doses of EPTC, and
in both cases the residue was formed in low concentration only. The Agency concludes, therefore,
that residues of EPTC in animal commodities represent a Category 3 situation under 40 CFR
§180.6(a): i.e., situations in which it is not possible to establish with certainty whether finite residues
will be incurred under reasonable worst-case exposure scenarios, but there is no reasonable
expectation of the occurrence of finite residues in animal commodities. Therefore, tolerances for
residues of EPTC in animal commodities need not be established.
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Residue data from crop field trials, processing studies, and livestock feeding studies have been
reviewed for the purpose of tolerance reassessment. Submitted residue data from field trial and
processing studies depict combined residues of EPTC and its three hydroxylated metabolites. These
data were obtained using analytical methods adequately validated for data collection. Storage
stability data support the integrity of the residue data for EPTC, but no data are currently available
to delineate the stability of the hydroxy metabolites in frozen plant matrices; these data have been
required. In general, field trials met the criteria for the required number of samples, and were
conducted in locations representative of the major growing regions specific to the crop tested. The
test systems utilized representative product formulations, applied at maximum rates, using application
equipment in accordance with label specifications. Residues of EPTC and its three hydroxylated
metabolites were nondetectable (<0.05 ppm) in the majority of samples of raw and processed
commodities from the submitted field trials.
The Agency is recommending revocation of tolerances for certain commodities for one or
more of the following reasons:
(1) crop groupings are obsolete or no longer applicable, thus warranting revocation of certain
crop group tolerances concomitant with establishment of tolerances for individual commodities.
(2) there are no longer significant livestock feed items for the commodity.
(3) currently there are no registered uses. Insufficient field trial data are available to reassess
the tolerances for flaxseed, citrus, and strawberries. Existing tolerances for these commodities have
been used for dietary exposure estimates.
b. Dietary Exposure from Food
The acute and chronic dietary exposure assessments were conducted using the Dietary
Exposure and Evaluation Model (DEEM™) system. DEEM can be used to estimate exposure to
constituents in foods comprising the diets of the U.S. population, including population subgroups.
The software contains food consumption data from the USDA Continuing Survey of Food Intake by
Individuals (CFSII) from 1989-1992.
For EPTC, inputs to the DEEM™ analysis include reassessed tolerances and percent crop
treated data. Tolerances published for EPTC under 40 CFR 180.117 have been reassessed (HED
Residue Chemistry Chapter, dated 9/25/98). The reassessed tolerance residue values, adjusted by a
factor of 15 to estimate the residues of concern, have been used as the basis for a DEEM™ Tier 1
analysis for acute dietary exposure, and a DEEM™ Tier 3 analysis for chronic dietary exposure. The
Tier 3 analysis used average field trial residue values (adjusted for marker compounds) and also
incorporated percent of crop treated data (BEAD Quantitative Usage Analysis for EPTC, dated
3/10/98). Where percent crop treated estimates indicated no EPTC use, a default minimum
assumption of 1% crop treated was applied.
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Where residues were nondetectable, one-half LOD (limit of detection) was assumed. Data
from processing studies indicate that residues of EPIC and its hydroxylated metabolites do not
concentrate in the processed fractions of the tested crops except sugar beet molasses (4x
concentration factor) and potato granules (1.4x). The residue file created using the DEEM ™
software for these dietary exposure analyses reflects these processing factors using a value of 1 for
adjustment factor #1 (adjustment for concentration/reduction of residues in processed commodities)
for commodities with no concentration. However, the concentration factor is reflected in the
reassessed tolerances for sugar beet molasses (e.g., the reassessed tolerance value for sugar beets is
0.1 ppm, and the reassessed tolerance value for sugar beet molasses, the processed commodity, is 0.4
ppm). Also, there is a citrus processing study that is outstanding. Because the processing study for
citrus has not been performed, all default concentration factors in the DEEM ™ software have been
retained for citrus food items.
(1) Acute Dietary Exposure Assessment
For the Tier 1 acute dietary exposure analysis of EPTC, exposure (food consumption) was
compared to an acute population adjusted dose of 0.067 mg/kg/day (FQPA Safety Factor Committee
Report, 11/18/98). The acute dietary risk analysis estimates the distribution of single day exposures
for the overall U.S. population and certain subgroups. The analysis evaluates exposure to the
chemical for each food commodity, and assumes uniform distribution of EPTC in the food supply.
As shown in Table 6, the acute dietary residue contribution at the 95th percentile occupied less
than 100% of the aPAD for any population subgroup, and therefore does not exceed the Agency's
level of concern. For non-probalistic acute dietary exposure the Agency uses the 95th percentile. For
the most highly exposed subgroup, children 1-6, residue contribution occupied 87.5% of the aPAD.
This Tier 1 acute analysis for EPTC is a conservative upper-bound estimate with all input residues
equal to the reassessed tolerance value and the assumption that 100% of the crop is treated
nationwide.
Table 6. Summary of Tier 1 EPTC Acute Dietary Exposure Analysis by DEEM.
Population
U.S. Population
All Infants <1 year
Nursing Infants <1 year
Non-nursing Infants <1 year
Children 1-6 years
Children 7- 12 years
95th Percentile
Exposure
0.027156
0.034682
0.012725
0.041815
0.058633
0.037088
% aPAD
40.53
51.76
18.99
62.41
87.51
55.36
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(2) Chronic Dietary Exposure Assessment
A chronic exposure analysis was performed using the DEEM ™ exposure modeling software.
Input values for the Tier 3 analysis include average residues from field trials and incorporated percent
of the crop treated information. Largest markets in terms of total pounds active ingredient are
allocated to corn (56%), dry beans/peas (8%), and potatoes (6%). Exposure (consumption) was
compared to the chronic population adjusted dose of 0.0025 mg/kg/day (FQPA Safety Factor
Committee Report, 11/18/98).
As shown in Table 7, the chronic dietary residue contribution occupies less than 100% of the
cPAD for all population subgroups, and therefore does not exceed the Agency's level of concern.
For the most highly exposed subgroup, children 1-6, the residue contribution occupies 17.4% of the
cPAD. This Tier 3 chronic analysis for EPTC is a refined estimate where average residues from crop
field trials and percent of crop treated data were used as inputs. For the majority of collected
samples, residues of EPTC and its hydroxylated metabolites were less than the detection limit of 0.02
or 0.04 ppm, depending on the matrix. Where residues were nondetectable, one-half the LOD was
assumed.
Table 7. Summary of Tier 3 EPTC Chronic Dietary Exposure Analysis by DEEM
Population Subgroup
U.S. Population
All Infants (<1 year)
Nursing Infants (<1 year)
Non-nursing Infants (<1 year)
Children (1-6 years)
Children (7- 12 years)
Anticipated Residue
Concentration (mg/kg/day)
0.000277
0.000281
0.000072
0.000369
0.000435
0.000340
Percent of Chronic PAD
9.6
11.3
2.9
14.8
17.4
13.6
c. Dietary Exposure from Drinking Water
The Agency has completed an analysis of available monitoring data and conducted a Tier I
screening level assessment for ground water and a Tier II assessment of surface water to estimate the
potential EPTC concentrations in ground water and surface water. Tier II modeling was used for
surface water, because the Agency's Tier I surface-water and ground-water models do not consider
volatilization. EPTC is volatile and mobile in soil and does not appear to be persistent under most
conditions. The metabolites of EPTC were not considered in the screening-level assessment due to
a lack of environmental fate data. Although limited, there are acceptable data available indicating that
metabolites of EPTC are less persistent than the parent compound.
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Surface Water Modeling:
Tier II surface water modeling was conducted for EPIC, on several major crops at high
exposure sites, using the EPA's PRZM and EXAMS models. The crops modeled were alfalfa, beans,
citrus, corn, and potatoes. They were selected, from label information, because they generally
represent the maximum application rates, number of applications, and the maximum total amount
applied. Lower concentrations were predicted for those scenarios having the lowest application rates
and the fewest number of applications.
PRZM/EXAMS output consists of estimated daily concentration in a standard water body for
the length of the simulation (typically 36 years). For each scenario, the annual peak value is the
highest daily concentration in a year, thus, there are 36 peak values. These values are sorted
(maximum to minimum) and the 90th percentile value is selected (i.e., 1-in-10-year). The range of
the 90th percentile peak EECs for the 10 scenarios was 3.67 to 41.69 |ig/L. Maximum peak
concentrations ranged from 6.35 to 57.35 |ig/L. The mean of the annual means ranged from 0.16 to
3.44 |ig/L. In general the lowest EECs were generated for beans and corn whereas the highest EECs
were for citrus. The peak (57.35 |ig/L) and mean (3.44 |ig/L) of the annual means of the citrus
scenario were used in the drinking water risk assessment.
The maximum concentrations were generated by the citrus scenario using an application rate
of 3.1 Ib/a.i. A applied three times per year with a 30 day interval between applications. Aquatic
degradation rates had to be estimated because data were not available. Agency guidance suggests
that the aquatic metabolism rate can be estimated by multiplying the aerobic soil metabolism rate by
0.5 ( multiplying the half-life by 2). As noted in the environmental fate assessment, EPTC did not
follow first-order decline so half-lives were estimated by using transformed linear regression and non-
transformed linear regression. The 90th percent upper bound on the mean aerobic soil metabolism
half-lives were 37 and 77 days for the linear and non-linear regression, respectively.
The aerobic aquatic metabolism half-lives thus were assumed to be 74 and 154 days (2 times
the aerobic soil half-life) for linear and non-linear regression, respectively. The EPTC surface water
concentrations presented above used the more conservative 154 day half-life. The half-life selected
made very little difference between the surface water concentrations for EPTC. The loss of EPTC
through volatilization was the dominant route of dissipation of EPTC in the surface water
environment. EPTC was assumed to be applied as a ground spray followed by a 2-inch soil
incorporation. Spray drift was assumed to be 1% of the pesticide applied for ground spray and zero
for granular application.
Ground Water Modeling:
The SCI-GROW (Screening Concentration in Ground Water) model was used to conduct a
Tier I ground-water assessment, although the concentration is probably over-predicted because SCI-
GROW does not consider volatilization as a route of dissipation. SCI-GROW was developed to
estimate potential ground-water concentrations for parent EPTC under hydrologically vulnerable
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conditions. The maximum EPTC concentration in ground water predicted by the SCI-GROW using
the maximum rate 6.1 Ib. a.i./ac and 2 applications was 5.89 jig/L and an average half-life of 58.5
days (In-transformed) and median Koc of 144.5. Using the average non-linear estimated half-life of
24 days, rather than 58.5 days, and with all other inputs remaining the same resulted in an estimated
ground water concentration of 1.84 |ig/L.
The persistence of EPTC in ground water would probably be greater than in surface water
since losses due to volatilization would be expected to be much less. EPTC is mobile in soil as
indicated by Kocs ranging from 136 to 266 mL/g. EPTC does not appear to be persistent, under most
conditions, but where microbial degradation is inhibited or volatilization is restricted EPTC could be
persistent (leached below the most microbially active zone).
Ground and surface water monitoring data from at least thirty states indicate that EPTC has
the potential to contaminate both ground and surface waters. Peak concentrations of EPTC in
surface water estimated by PRZM/EXAMS (6.35 to 57.35 //g/L) corresponds reasonably well with
the range of the highest surface water concentrations of EPTC observed in monitoring data (10 to
40 //g/L) although the 40 //g/L value is outside the range of the method calibration. The
concentration of EPTC in ground water estimated by SCI-GROW (1.84 //g/L) also corresponds
reasonably well with the range of the highest ground water concentrations of EPTC observed in
monitoring data (0.5 to 2.7 //g/L).
A Drinking Water Level of Comparison (DWLOC) is a theoretical upper limit on a pesticide's
concentration in drinking water in light of total aggregate exposure to a pesticide in food, drinking
water, and through residential uses. OPP uses DWLOCs internally in the risk assessment process as
a surrogate measure of potential exposure associated with pesticide through drinking water.
DWLOC values are not regulatory standards for drinking water. They do have an indirect regulatory
impact through aggregate exposure and risk assessments.
DWLOCs for Chronic (Non-Cancer) Exposure
Chronic DWLOCs were calculated based on the chronic dietary (food) exposure, default body
weights ,and water consumption figures. The Agency' s default body weights and water consumption
values used to calculate DWLOCs are as follows: 70/kg/2/L (adult male), 60 kg/2L (adult female),
and 10 kg/lL (child). To calculate the DWLOC, the chronic dietary food exposure was subtracted
from the chronic PAD using the equation
[chronic water exposure (mg/kg/day) x (body weight)]
DWLOCcteomc =
[consumption (L) x 10"3 mg/^ig]
where chronic water exposure (mg/kg/day) = [cPAD - (chronic food (mg/kg/day)]
As shown in Table 8, the drinking water estimated concentrations from modeling in ground
water (1.84 //g/L),and surface water (3.44 //g/L), are all below the Agency's DWLOCs for EPTC
for all population subgroups. Based on the available information, residues of EPTC in drinking water
do not result in an unacceptable contribution to chronic dietary exposure at this time.
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Table 8. Drinking Water Levels of Com
Population
Subgroup
Adult male
Adult Female
Infants <1 yr
Children 1-6
Non-Hispanic Black
Chronic
PAD(mg/
kg/day)
0.0025
0.0025
0.0025
0.0025
0.0025
Food
Exposure
(mg/kg/day)
0.000231
0.000229
0.000281
0.000435
0.000271
parison for Chronic Dietary Exposure.
Max. Water
Exposure
(mg/kg/day)
0.00227
0.00227
0.00222
0.00207
0.00223
DWLOC^^
(Mg/L)
78
68
20
20
76
PRZM-
EXAMS
C"g/L)
2.44
3.44
3.44
3.44
3.44
SCI-
GROW
(Mg/L)
1.84
1.84
1.84
1.84
1.84
DWLOCs for Acute Exposure
Acute DWLOCs were calculated based on the acute dietary (food) exposure, default body
weights, and water consumption figures. The Agency' s default body weights and water consumption
values used to calculate DWLOCs are as follows: 70/kg/2 L (adult male), 60 kg/2 L (adult female),
and 10 kg/lL (child). To calculate the acute DWLOC, the acute dietary food exposure was
subtracted from the acute PAD using the equation
DWLOCj^te = [acute water exposure (mg/kg/day) x (body weight)]
[consumption (L) x 10"3 mg/Aig]
where acute water exposure (mg/kg/day) = [aPAD - acute food (mg/kg/day)].
As shown in Table 9, the drinking water estimated concentrations in ground water (1.84
Mg/L) and surface water (57.35 //g/L) are below the Agency's DWLOCs for EPTC. The Agency
concludes that based on the available information, modeled residues in drinking water do not exceed
the Agency's level of concern for contribution to acute dietary exposure at this time.
Table 9. Drinking Water Levels of Comparison for Acute Dietary Exposure.
Population
Subgroup
Adult Male
Adult Female
Infants <1 yr
Children 1-6
Acute
PAD
0.067
0.067
0.067
0.067
Food Exposure
(mg/kg/day)
0.027156
0.027156
0.041815
0.058633
Water Exposure
mg/kg/day
0.039844
0.039844
0.025185
0.0084
DWLOCacnte
(Mg/L)
1395
1195
252
84
PRZM EXAMS
(Mg/L)
57
57
57
57
SCI-GROW
(Mg/L)
2.00
2.00
2.00
2.00
d. Occupational and Non-Occupational Exposures
Occupational and residential exposure to EPTC residues via dermal and inhalation routes can
occur during handling activities such as mixing, loading, and applying; however, the potential for
postapplication occupational exposure is minimal. Because EPTC is applied as a soil directed spray
and immediately incorporated, or as a soil injection well before plants are mature, the potential for
post-application dermal exposure during harvest activities is minimal. In addition, there is a potential
for inadvertent oral exposure to children from eating EPTC-treated soil and/or granules. Based on
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toxicological criteria and potential for exposure, the Agency has conducted dermal and inhalation
exposure assessments for the occupational and residential handler, and for residential postapplication
inadvertent oral ingestion soil/granulars exposure to children.
e. Occupational Exposure
Occupational Handler Exposure Scenarios
The Agency has identified 12 major exposure scenarios for which there is potential for
occupational handler exposure during mixing, loading, and applying products containing EPTC to
agricultural crops and to non-agricultural use sites. These occupational scenarios reflect a broad
range of application equipment, application methods, and use sites. The scenarios were classified as
short-term (1-7 days) and intermediate-term (1 week to several months) based primarily on the
frequency of exposure. A long term exposure duration is not expected, because applications are
typically made only once per year or for application well spaced in time. The estimated exposures
considered baseline protection (long pants and a long-sleeved shirt, shoes and socks, no gloves, and
an open cab or tractor), additional personal protective equipment (PPE, which includes a double layer
of clothing and gloves and/or a dust/mist respirator), and engineering controls (closed mixing/loading
systems for liquids and granulars and enclosed cabs/trucks).
Occupational Handler Exposure Data Sources and Assumptions
The registrant submitted a biological monitoring study conducted with cycloate. Although
the Agency agreed that acceptable data from monitoring studies conducted with cycloate could be
used to estimate exposure of other thiocarbamates, data from the submitted study were not used in
this risk assessment. In the study, an EC formulation was mixed, loaded and applied using
groundboom spray equipment mounted on either open- or closed-cab equipment. The study was not
used in this assessment because an inadequate number of replicates were completed for each exposure
scenario and replicates used varying PPE, equipment and/or engineering controls and the subjects
wore a varying range of protective clothing during handling and application activities. Data on upper
arms, forearms, thighs, lower legs, and hands are missing and would have to be extrapolated from
other scenarios in the study. PHED mixer/loader/applicator data sets for ground application of liquid
formulations better represents the registered EPTC uses and the resulting scenario-specific handler
exposures.
Occupational Postapplication Exposure
The current restricted entry interval (REI) for EPTC is 12 hours, with the exception that if
the product is soil-injected or soil-incorporated, the Worker Protection Standard, under certain
circumstances, allows workers to enter the treated area if there will be no contact with anything that
has been treated.
EPTC is applied is a soil-directed herbicide that must be thoroughly incorporated immediately
following application through mechanical means or watering-in. It is applied as a pre-plant application
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and as a post-emergent application to established plants. Post-emergent applications include crops
such as tomatoes and beans, where hand labor activities involving contact with the soil subsurface
such as staking are common. For post-emergent applications to ornamentals in nurseries, there are
no restrictions on the timing of transplanting/harvesting the ornamentals following application. For
all crops, labeling instructions direct users to use shallow cultivation (i.e., mechanical or hand
raking/hoeing) after application to control weeds that escape control.
No product-specific postapplication exposure data were available for EPIC, therefore a
surrogate range-finder postapplication assessment was conducted. The surrogate assessment
assumed that 20 percent of the EPIC applied was available for transfer (i.e., dislodgeable) at 12
hours following application/incorporation. A transfer coefficient of 1000 cm^/hr would be
appropriate for tasks that would involve contact with the soil subsurface, such as hoeing, raking,
staking, thinning, irrigating, and transplanting (ornamentals). An eight hour work day and the
maximum EPIC application rate of 15 pounds active ingredient per acre was used. Using the high
end assumptions in this surrogate assessment, the margin of exposure at 12 hours after
application/incorporation was over a thousand.
Therefore, the EPA is establishing a 12-hour restricted-entry interval for all uses of EPIC.
The labeling should state that the REI does not begin until EPTC has been appropriately incorporated
as directed. The WPS exception allowing unrestricted entry to treated areas following application
and appropriate incorporation provided the soil subsurface will not be contacted should be cited on
the labeling using the standard language for soil incorporation.
f. 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) data bases for reported incident
information for EPTC. Of the 19 cases submitted to the California Pesticide Illness Surveillance
Program (1982-1995), 17 involved use of EPTC alone and were judged to be responsible for the
health effects. When the acute toxicity data for individual products are reviewed, the Agency will
impose the appropriate eyewear based on the toxicity category. Additional dermal protective
equipment, such as double layers or chemical resistant aprons, will be required based on the EPTC risk
assessment, for some handler and applicator scenarios as discussed in section IV of this document.
g. Residential Handler Exposure
Potential EPTC residential use sites may include a variety of shade trees, evergreens, and
annual or perennial ornamentals. EPTC is typically applied only to bare soil once before planting or
after weeding under ornamentals followed by soil incorporation. Examples of typical usage of a
granular formulation in the home garden would include pre-planted application and incorporation
with a rototiller, post-plant application incorporated into the soils to a depth of 2-3 inches using a
hand rake or hoe, and weed control in established trees and shrubs by incorporation into the top 6
25
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inches of soil In contrast to occupational workers, individuals in residential settings are more likely
to transplant seedlings and plant seeds by hand. In addition, there is a potential for inadvertent oral
exposure to children from eating EPTC-treated soil and/or granules.
Residential handler exposure to EPTC residues via dermal and inhalation routes can occur
during handling, mixing, loading, and applying activities. The exposure duration of these activities
was classified as short-term (1-7 days), because EPTC is usually applied only once per year up to 3
applications well-spaced in time.
Residential Handler Exposure Scenarios
The Agency has determined that there is potential exposure to residential mixer, loader, and
applicators during the usual use patterns associated with EPTC. Based on the use patterns, four
major residential exposure scenarios were identified for EPTC. These involve loading/applying
granulars with a push-type spreader, a belly grinder spreader, by hand/spoon, or applying granulars
with a shaker can.
Residential Handler Exposure Data Sources and Assumptions
Residential handler exposure assessments were completed by the Agency assuming an
exposure scenario for homeowners wearing the following attire: short sleeved shirt, short pants, shoes
and socks, and no gloves or respirator. PHED values used to estimate daily unit exposure values
were taken from the Draft Standard Operating Procedures (SOPs) for Residential Exposure
Assessments (December 1997).
The area treated per day was assumed to be 10,000 square feet for a push type spreader,
1,000 square foot for belly grinder spreader, and 151bs lOoz for shaker can and hand/spoon
application. Calculations were made using the maximum application rates for crops as stated on the
available EPTC labels. Application rates represent the range of exposure levels associated with the
various use patterns.
Because no exposure data sets for application with a granular shaker can are available in
PHED, the unit exposure data for granular application using a belly grinder was utilized for the
granular shaker can scenario. Exposure estimates for the belly grinder is considered representative
of shaker can because both are held at approximately the same height during application. The entire
container (15 Ib. 10 oz.) is assumed to be applied in one day.
Residential Postapplication Exposure Scenarios
The Agency has determined that there is a potential for non-occupational postapplication
exposure from use by the residential handler, and from commercial use of EPTC in parks, recreational
areas, and golf courses (sand traps). The Agency believes that postapplication dermal exposure at
these sites is minimal for the following reasons: 1) use on golf courses is limited to sand traps, 2)
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EPTC is volatile and dissipates quickly; and 3) it is soil incorporated, making very little available at
upper soil layers. Thus, a quantitative assessment of the potential exposure to adults and children
from these sources is not needed.
The Agency has also determined that there is a potential for inadvertent oral exposure to
children from eating EPTC-treated soil and/or granules. Although there is little exposure potential
for children's ingestion of EPTC granules, it is the Agency's policy to routinely conduct screening
level assessments for this scenario, when a granular pesticide may be applied in residential settings.
The scenarios likely to result in postapplication exposures are as follows:
A. Ingestion of granules in treated areas (toddler);
B. Incidental ingestion of soil from pesticide-treated residential areas (toddler);
Data Sources and Assumptions for Postapplication Exposure Calculations.
The equations and assumptions used for each of the scenarios were taken from the Draft
Standard Operating Procedures (SOPs) for Residential Exposure Assessments guidance document,
and are given below. The following general assumptions were made for all scenarios:
On the day of application, it was assumed that 100 percent of the application rate is
available from the soil as dislodgeable residue.
• For children ages 1-6 the assumed soil ingestion rate is 100 mg/day.
• The assumed ingestion rate for dry pesticide formulations (i.e., granules) is 0.23
grams/day for toddlers age 3 years. This is based on the assumption that if 5.0
pounds of product were applied to a 1,000 square feet of land, the amount of product
per square foot would be 2.3 g/ft2. The toddler would consume one-tenth of the
product available in a square foot.
Toddlers (age 3 years), representing the 1 to 6 year old age group, are assumed to
weigh 15 kg.
4. Risk Characterization
a. Dietary Risk
The aggregate acute dietary risk estimates include exposure to EPTC residues in food and
water. Exposure (food only) to combined residues of EPTC and its metabolites of toxicological
concern based on an upper-bound analysis using tolerance-level residues, and assuming 100% of crop
treated, represents 87.5% of the acute PAD for the most highly exposed population subgroup
(children 1-6 years). Exposure to all other groups represents less than 62.4% of the acute PAD.
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Using conservative screening-level models, the estimated maximum peak concentrations of EPTC in
surface water is 57 //g/L. This estimated peak concentration is slightly less than the Agency's
drinking water level of comparison for exposure to EPTC in drinking water as a contribution to
aggregate acute dietary risk. Based on the available information, the Agency concludes that acute
dietary exposure to EPTC does not exceed the Agency's level of concern.
Chronic (non-cancer) aggregate risk estimates also do not exceed the Agency's level of
concern. The aggregate chronic dietary risk estimates include exposure to EPTC residues in food
and water. No chronic residential use scenarios were identified. Exposure (food only) to combined
residues of EPTC and its metabolites of toxicological concern based on a Tier 3 refinement using
average residues from field trial and percent of crop treated data, represents 17.4% of the chronic
PAD for the most highly exposed population subgroup (children 1-6 years). Exposure to each of the
other groups represents less than 14.8% of the chronic PAD for that group. Using conservative
screening-level models, the estimated maximum of EPTC in surface water is 3 //g/L. * This estimated
average concentration is less than the Agency's drinking water level of comparison for exposure to
EPTC in drinking water as a contribution to aggregate chronic dietary risk. Based on the available
information, the Agency concludes that chronic dietary exposure to EPTC does not exceed the
Agency's level of concern for any population.
b. Occupational Handler Risk
Because different endpoint effects were selected for the assessment of dermal and inhalation
risks, separate risk assessments were conducted for dermal and inhalation exposures. MOEs for
occupational handlers were derived based upon comparison of dermal exposure estimates against
either a LOAEL of 200 mg/kg/day for short-term exposure or a NOAEL of 9 mg/kg/day for
intermediate-term exposure (table 4). Both the short and intermediate-term LOAEL/NOAELs were
from neurotoxicity studies in the rat (oral administration). A dermal absorption factor of 5% was
applied to dermal exposure estimates. MOEs were also derived based upon comparison of inhalation
exposure estimates against a NOAEL of 58 mg/m3 (15.1 mg/kg/day) for exposure from 1 to 21 days
in duration (table 4), and against a NOAEL of 8.3 mg/m3 (1.26 mg/kg/day) for exposures greater
than 21 days in duration. The uncertainty factors and target MOEs for occupational workers are 300
for short-term dermal risk, 100 for intermediate-term dermal risk, and 100 for short- and
intermediate-term inhalation risk. MOEs below this level would represent a risk concern for the
Agency.
A summary of the short-term and intermediate-term risk estimates for baseline, additional
PPE, and engineering controls is presented in Tables 9, 10, and 11. Except for scenario 9, which
include chemical resistant gloves, baseline dermal unit exposure represents long pants, long sleeved
shirt, shoe and sock, no gloves, open mixing/loading, open cab tractor. Additional PPE for all dermal
scenarios includes double layer of clothing (50% protection factor for clothing) and chemical resistant
gloves. Depending on the scenario, engineering controls include closed mixing/loading, single layer
clothing, chemical resistant gloves, chemical resistant apron, respirator, closed cockpit.
28
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Three short-term and seven intermediate-term scenarios require PPE to mitigate dermal and
inhalation risks from handling and/or applying EPTC-containing products. PPE is required to
mitigate risk from dermal exposure during mixing/loading EC formulations for chemigation and
ground application, and for mixing/loading/applying EC formulations using hand-held equipment
(a low pressure handwand).
Short-Term Risk Characterization
The estimates for short-term dermal and inhalation risks have not been combined because
dermal and inhalation endpoint effects are different. Target MOE's for short term occupational
dermal risk equals 300, and MOE's for intermediate dermal risk equal 100. Target MOE's for short
and intermediate occupational inhalation risk both equal 100.
Dermal exposures reflecting baseline protective clothing result in MOEs that exceed the
Agency's level of concern for only three of 12 short-term scenarios, in which MOEs ranged from 69
to 190, Table 4). For these three scenarios, (la) mixing/loading EC formulations for chemigation;
(Ib) mixing/loading EC formulations for ground application; and (8) mixing/loading/applying EC
formulations to the soil with a low pressure handwand, additional PPE (double layer of clothing and
chemical resistant gloves) are required to mitigate exposure/risk. Baseline and/or PPE exposure
assessments were not performed for two scenarios because methodologies other than mechanical
mixing/loading/applying are not feasible. Engineering controls are required to mitigate dermal
exposure for scenarios (Ic) mixing/loading EC formulation for impregnation of dry bulk fertilizer
(closed system) and (7) applying granular with aerial equipment. Provided that EPTC short-term
dermal exposures are mitigated for the above specified exposure scenarios with PPE and/or
engineering controls, MOEs for dermal exposure/risk do not exceed Agency's level of concern.
Inhalation exposures reflecting baseline protective clothing for all assessed exposure scenarios
do not exceed the Agency's level of risk concern; MOEs were greater than 290 (Table 10). Short-
term baseline and/or PPE exposure assessments were not performed for two scenarios, because
application methodologies other than mechanical mixing/loading/applying are not feasible. Therefore,
engineering controls, which include closed system or enclosed airplane cockpit, are required to
mitigate inhalation exposure for these two scenarios (Ic) mixing/loading EC formulation for
impregnation of dry bulk fertilizer (closed system), and (7) applying granular with aerial equipment.
MOEs with engineering controls are greater than 520.
Intermediate-Term Risk Characterization
The estimates for intermediate-term dermal and inhalation risks have not been not combined
because dermal and inhalation endpoint effects are different. Target MOE for dermal and inhalation
is 100.
Dermal exposures reflecting baseline protective clothing result in MOEs that exceed the
Agency's level of concern for seven of 12 scenarios. For these seven scenarios, (la) intermediate-
term, (Ib), (Id), (5), (8), (11), and the MOEs ranging from 3 to 84 require additional PPE (double
29
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layer of clothing and chemical resistant gloves) to mitigate exposure/risk. Provided that EPTC
intermediate-term dermal exposures are mitigated for the above specified exposure scenarios with
PPE, MOEs ranging from 150 to 5,600 do not exceed the Agency's level of concern. Baseline and/or
PPE exposure assessments were not performed for two scenarios, because application methodologies
other than mechanical mixing/loading/applying are not feasible. Therefore, engineering controls are
required to mitigate dermal exposure for scenarios: (Ic) mixing/loading EC formulation for
impregnation of dry bulk fertilizer (closed system), and (7) applying granular with aerial equipment.
Although engineering controls for these two scenarios decrease dermal exposure, the estimated MOE
of 60 for mixing/loading EC formulation for impregnation of dry bulk fertilizer (closed system)
exceeds the Agency's level of concern.
Inhalation exposures reflecting baseline protective clothing result in MOEs that exceed the
Agency's level of concern for only three of 12 intermediate scenarios, in which MOEs ranged from
40 to 90. For these three scenarios [(la) mixing/loading emulsifiable concentrate for chemigation;
(2b) loading granular for aerial application; and (4) applying dry bulk fertilizer in drop type tractor
drawn spreaders at 500 acres per day for all application rates], additional PPE (organic vapor
respirator) are required to mitigate exposure/risk. Provided that EPTC intermediate-term inhalation
exposures are mitigated for the above specified exposure scenarios with PPE, MOEs ranging from
210 to 320 do not exceed the Agency's level of concern. Baseline and/or PPE exposure assessments
were not performed for two scenarios because application methodologies other than mechanical
mixing/loading/applying are not feasible. Therefore, engineering controls are required to mitigate
inhalation exposure for these two scenarios, (Ic) mixing/loading EC formulation for impregnation
of dry bulk fertilizer (closed system), and (7) applying granular with aerial equipment. Although
engineering controls for these two scenarios decrease inhalation exposure, estimated MOEs are 75
or 83 still exceed the Agency's level of concern.
A number of issues must be considered when interpreting the results of the occupational
short- and intermediate-term risk assessment. For example, the acres treated per day may vary
depending on the crop and application equipment as follows:
10 acres for commercial ornamental settings using mechanical applications, and 1 acre for hand held
equipment, except the push type granular spreader that cover 5 acres;
40 acres for citrus groves rights-of-way sprayer application;
80 acres for drop-type tractor drawn spreader and groundboom applications in an agricultural setting;
350 acres for non-forestry aerial and chemigation applications (including flaggers supporting aerial
applications).
For impregnation of dry bulk fertilizer, the total amount of treated fertilizer that can be applied
in one day is constant (i.e. the application rate and the area treated vary inversely). For example, 500
acres per day can be treated when fertilizer is applied at a rate of 200 Ibs per acre. At a rate of 700
Ibs of fertilizer per acre, only 143 acres can be treated in one work day. The number of pounds that
30
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can be mixed and loaded in one day was estimated by the number of 10-ton trucks that can be loaded
per hour by one individual. Assuming that five, 10-ton trucks could be filled with treated fertilizer
per hour, and that an individual works for eight hours, then 40 trucks (400 tons, or 800,000 Ibs)
could be loaded per work day.
It must be noted that the unit exposure values for mixing/loading emulsifiable concentrate for
impregnation on dry fertilizer were taken from PHED and do not reflect the actual use of the
pesticide. The PHED data was determined by loading and mixing fertilizer from bags, not
mechanically mixing and loading fertilizer into trucks. For non-agricultural uses, if more than an acre
is being treated, the Agency assumes that a push type spreader is typically used for applying a
granular or that a rights-of-way sprayer is typically used for applying a liquid. For application to golf
course sandtraps, which are believed to occupy an area equivalent to the area of greens, the treated
area is assumed to be about 125,000 sq. ft. using a push type spreader, and 43,560 sq. ft. using a belly
grinder spreader.
31
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Table 10. Summary of Occupational Handler Dermal Risk for EPTC at Baseline, with PPE, and Engineering Controls
Exposure Scenario
(Scenario #)
Short-Term MOE = 300
Baseline
PPE
Engineering
Controls
Intermediate Term MOE = 100
Baseline
PPE
Engineering
Controls
Input Parameters and
Potential Mitigation
Measures
MIXER/LOADER EXPOSURE
Mixing/Loading
Emulsifiable Concentrate for
Chemigation (la)
Mixing/Loading
Emulsifiable Concentrate
for Ground Application (Ib)
Mixing/Loading
Emulsifiable Concentrate
for Impregnation on Dry
Bulk Fertilizer (Closed
System) (Ic)
Mixing/Loading
Emulsifiable Concentrate
for Handgun (Hydraulic
Sprayer) Application (Id)
Loading Granular in Drop-
Type Tractor Drawn
Spreader (2a)
Loading Granular with
Aerial Equipment (2b)
69
200-1,600
N/A
400
69,000
24,000
12,000
34,000
N/A
N/A
N/A
N/A
N/A
N/A
68,000
N/A
N/A
N/A
3
9-72
N/A
18-72
3,100
1,100
529
1,500
N/A
3,100
N/A
N/A
N/A
N/A
60-430
N/A
N/A
N/A
The number of acres
treated/day (350) is a major
driver for this exposure
A 6 Ib a.i./A max rate and the
number of acre treated/day
(80) for ag crops (other than
citrus, cotton, ornamentals)
results in the highest exposures.
Additional mitigation can be
achieved by reduction in the
amount handled/day or
additional information on this
use.
A 6 Ib a.i./A max rate and the
number of acres treated (40)
for non-bearing citrus results in
the highest exposures.
N/A
N/A
APPLICATOR EXPOSURE
Applying Spray to the Soil
with a Groundboom Sprayer
(3)
Applying Dry Bulk
Fertilizer
in Drop Type Tractor
Drawn Spreader (4)
Applying Spray to the Soil
with Handgun
(Rights-of-Way Sprayer)
Application (5)
Applying Granular with a
Drop-Type
Tractor Drawn Spreader (6)
Applying Granular with
Aerial Equipment (7)
42,000
9,000
900
59,000
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
125,000
2,000
420
40-160
2,700
N/A
N/A
N/A
180-720
N/A
N/A
N/A
N/A
N/A
N/A
5,600
N/A
N/A
A 6 Ib a.i./A max rate and the
number of acres treated (40)
for non-bearing citrus results in
the highest exposures.
N/A
N/A
MIXER/LOADER/APPLICATOR EXPOSURES
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil with a Low Pressure
Hand Wand (8)
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil with a Backpack
Sprayer (9)
190-470
7,500
50,000
N/A
N/A
N/A
8-21
340
2,300
N/A
N/A
N/A
Exposure is activity driven; the
unit exposure value for
handheld equipment is high.
Low confidence in hand/dermal
baseline and PPE data; no PF
applied.
N/A
32
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Exposure Scenario
(Scenario #)
Loading/ Applying Granular
with a Push-Type Spreader
(10)
Loading/ Applying Granular
with a Belly Grinder
Spreader (11)
Short-Term MOE = 300
Baseline
1,300
1,900
PPE
N/A
N/A
Engineering
Controls
N/A
N/A
Intermediate Term MOE = 100
Baseline
58-300
84-250
PPE
230
150
Engineering
Controls
N/A
N/A
Input Parameters and
Potential Mitigation
Measures
A 15 Ib a.i./A max rate on
ornamentals results in the
highest exposures.
A 15 Ib a.i./A max rate on
ornamentals results in the
highest exposures.
FLAGGER EXPOSURE
Flagging Granular
Applications (12)
72,000
N/A
N/A
3,200
N/A
N/A
N/A
Table 11. Summary of Short-Term
Engineering Controls
Occupational Handler Inhalation Risk for EPTC at Baseline, with PPE, and
Exposure Scenario
(Scenario #)
Short Term MOE = 100
Baseline
PPE
Engineering
Controls
Input Parameters and Potential Mitigation
Measures
MIXER/LOADER EXPOSURE
Mixing/Loading Emulsifiable
Concentrate for Chemigation
(la)
Mixing/Loading Emulsifiable
Concentrate for Ground
Application (Ib)
Mixing/Loading Emulsifiable
Concentrate for Impregnation
on Dry Bulk Fertilizer (Closed
System) (Ic)
Mixing/Loading Emulsifiable
Concentrate for Handgun
(Hydraulic Sprayer)
Application (Id)
Loading Granular in Drop-
Type tractor Drawn Spreader
(2a)
Loading Granular with Aerial
Equipment (2b)
630
1,800
N/A
3,700
1,300
440
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
520
N/A
N/A
N/A
Exposure is driven by the amount handled;
more acreage can be treated by chemigation
than with vehicles.
The highest application rate and 200 Ib
fertilizer/day results in the highest exposure.
Exposure is driven by the amount handled;
more acreage can be treated via aircraft than
with ground vehicles.
APPLICATOR EXPOSURES
Applying Spray to the Soil
with a Groundboom Sprayer
(3)
Applying Dry Bulk Fertilizer
in Drop Type Tractor Drawn
Spreader (4)
Applying Spray to the Soil
with Handgun
(Rights-of-Way Sprayer)
Application (5)
Applying Granular with a
Drop-Type Tractor Drawn
Spreader (6)
Applying Granular with
Aerial Equipment (7)
3,000
290
1,100
1,600
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
580
The 6 Ib/A rate results in the greatest
exposure.
Alfalfa 350A - low confidence in hand/dermal
& inhalation data.
MIXER/LOADER/APPLICATOR EXPOSURES
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil with a Low Pressure
Hand Wand (8)
2,300
N/A
N/A
33
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Exposure Scenario
(Scenario #)
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil with a Backpack
Sprayer (9)
Loading/ Applying Granular
with a Push-Type Spreader
(10)
Loading/ Applying Granular
with a Belly Grinder
Spreader (11)
Short Term MOE = 100
Baseline
2,300
2,200
1,100
PPE
N/A
N/A
N/A
Engineering
Controls
N/A
N/A
N/A
Input Parameters and Potential Mitigation
Measures
FLAGGER EXPOSURE
Flagging Granular
Applications (12)
5000
N/A
N/A
Baseline inhalation unit exposure represents no respirator. Application rates are based on the maximum application rates listed on the EPTC
labels. Amount handled per day are from EPA estimates of acres treated, or square feet treated in a 8-hour work day
Table 12. Summary of Intermediate-Term Occupational Handler Inhalation Risk for EPTC at Baseline, with PPE, and
Engineering Controls.
Exposure Scenario
(Scenario #)
Intermediate Term MOE = 100
Baseline
PPE
Engineering
Controls
Input Parameters and Potential Mitigation
Measures
MIXER/LOADER EXPOSURE
Mixing/Loading Emulsifiable
Concentrate for Chemigation
(la)
Mixing/Loading Emulsifiable
Concentrate for Ground
Application (Ib)
Mixing/Loading Emulsifiable
Concentrate for Impregnation
on Dry Bulk Fertilizer (Closed
System) (Ic)
Mixing/Loading Emulsifiable
Concentrate for Handgun
(Hydraulic Sprayer)
Application (Id)
Loading Granular in Drop-
Type tractor Drawn Spreader
(2a)
Loading Granular with Aerial
Equipment (2b)
90
260
N/A
530
170
64
450
N/A
N/A
N/A
N/A
320
N/A
N/A
75-350
N/A
N/A
N/A
Exposure is driven by the amount handled;
more acreage can be treated by chemigation
than with vehicles.
The highest application rate and 200 Ib
fertilizer/day results in the highest exposure.
Exposure is driven by the amount handled;
more acreage can be treated via aircraft than
with ground vehicles.
APPLICATOR EXPOSURES
Applying Spray to the Soil
with a Groundboom Sprayer
(3)
Applying Dry Bulk Fertilizer
in Drop Type Tractor Drawn
Spreader (4)
Applying Spray to the Soil
with Handgun
(Rights-of-Way Sprayer)
Application (5)
Applying Granular with a
Drop-Type Tractor Drawn
Spreader (6)
430
40-300
160
230
N/A
210
N/A
N/A
N/A
N/A
N/A
N/A
The 6 Ib/A rate results in the greatest
exposure.
34
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Exposure Scenario
(Scenario #)
Applying Granular with
Aerial Equipment (7)
Intermediate Term MOE = 100
Baseline
N/A
PPE
N/A
Engineering
Controls
83
Input Parameters and Potential Mitigation
Measures
Alfalfa 350A - low confidence in hand/dermal
& inhalation data.
MIXER/LOADER/APPLICATOR EXPOSURES
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil with a Low Pressure
Hand Wand (8)
Mixing/Loading/Applying
Emulsifiable Concentrate to
the Soil a with Backpack
Sprayer (9)
Loading/ Applying Granular
with a Push-Type Spreader
(10)
Loading/ Applying Granular
with a Belly grinder Spreader
(11)
340
340
320
160
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
FLAGGER EXPOSURE
Flagging Granular
Applications (12)
720
N/A
N/A
Baseline inhalation unit exposure represents no respirator. Application rates are based on the maximum application rates listed on the EPTC labels.
Amount handled per day are from EPA estimates of acres treated, or square feet treated in a 8-hour work day.
C.
Residential Handler Risk Characterization
Because different endpoint effects were selected for the assessment of residential dermal and
inhalation risks, separate risk assessments were conducted for dermal and inhalation exposures.
MOEs for residential handlers were derived based upon comparison of dermal exposure estimates
against a LOAEL of 200 mg/kg/day for short-term exposure. The short-term LOAEL is from a
neurotoxicity study in the rat (oral administration). Therefore, the absorbed fraction of each dose was
calculated in order to convert to an equivalent oral dose using a dermal absorption factor of 5%.
MOEs were also derived based upon comparison of inhalation exposure estimates against a NO AEL
of 58 mg/m3 which translates to 15.1 mg/kg/day. The uncertainty factors and target MOEs for
residential populations (including the lOx FQPA safety factor) are 3000 for short-term dermal risk
and 1000 for short-term inhalation risk.
Details of the residential handler short-term dermal and inhalation risk estimates are shown
in th following table. Dermal exposures do not exceed the Agency's level of concern for three of the
four residential handler scenarios. Application of granular formulations with a push-type spreader,
by hand/spoon, and by shaker can result in margins of exposure (MOEs) ranging from 5,700 to
81,000. Application with a belly grinder spreader, however, results in an MOE of 2,200 which
exceeds the Agency's level of concern. In order to be eligible for reregi strati on the registrant will be
required to drop the residential handler use of the belly grinder spreader. Inhalation exposures do
not exceed the Agency's level of concern for any residential handler scenario; MOEs ranged from
15,000 to 150,000.
35
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Table 13. Residential Handler Short-term Dermal and Inhalation Risk to EPTC at Baseline.
Exposure Scenario
(Scenario. #)
Crop/Use
Baseline Dermal
Daily Dose
(mg/kg/day)"
Short-
term
MOE"
Baseline Inhalation
Dally Dose
(mg/kg/day)c
Short-term
MOE"
MIXER/LOADER/APPLICATOR EXPOSURE
Loading/ Applying Granular with a Push- Type
Spreader (1)
Loading/ Applying Granular with a Belly
grinder Spreader (2)
Loading/ Applying Granular by Hand/Spoon (3)
Applying Granular Shaker Can (4)
Ornamentals
Ornamentals
Ornamentals
Ornamentals
0.0025
0.090
0.040
0.03
81,000
2,200
5,700
7,100
0.00010
0.0010
0.0008
0.0003
150,000
15,000
20,000
47,000
1 Daily Dermal Dose (mg/kg/day) = (Daily Dermal Exposure (mg/day) / Body Weight (70 kg)) x Absorption Factor (5%).
b Short-term Dermal MOE = LOAEL (200 mg/kg/day) / Daily Dermal Dose (mg/kg/day). The acceptable MOE value is 3000.
c Daily Inhalation Dose (mg/kg/day) = Daily Inhalation Exposure (mg/day) / Body weight (70kg).
d Short-term Inhalation MOE = NOAEL(15.1 mg/kg/day) / Daily Inhalation Dose (mg/kg/day). The acceptable value is 1000.
Residential Postapplication Risk Characterization
Details of the postapplication risk estimates are presented in the following table. Incidental
ingestion of EPTC treated soil is not a risk concern for toddlers playing in treated areas. However,
the estimated ingestion of granules in treated areas by a toddler based on standard assumptions from
the Draft Residential SOPs results in an MOE of 570 which greatly exceeds the Agency's level of
concern. While it is the Agency's policy to routinely conduct screening level assessments for
incidental ingestion of granules from treated areas, the Agency believes a toddler's exposure to EPTC
granules may be outside the scope of concern because of the small formulation particle size.
Based on information provided by the registrant on the particle density of the 2.3% a.i.
granular EPTC formulation, the Agency believes that there is little exposure potential for children's
ingestion of EPTC granules. The particle size is relatively small and if used according to label
directions and soil incorporated, it is unlikely that EPTC granules would be accessible to a child. The
Agency estimates that fewer than 50 EPTC granules, if eaten, would result in adverse effects.
However, the Agency also recommends that the potential for children's exposure to EPTC granules
be further minimized by an additional labeling which states," Keep off sidewalks, driveways, patios,
or similar surfaces.
36
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Table 14. EPTC Residential Post-Application Scenarios and Estimated Risks.
Exposure Scenario
(Scenario #)
Eating Granules in
Treated Areas
Soil Ingestion in
Treated Areas
Receptor
Toddler
Toddler
Application Rate Per
Treatment (AR) (Ibs a.i./A)
5.0
5.0
SR,
Og/g)"
-
38
IgR (g/day)
or (mg/day)b
0.23
100
F (a.i.)
0.023
-
BW(kg)
15
15
ADD
(nig/kg/day)1
0.35
0.00025
MOE"
570
790,000
' Soil residue Og/g) = [AR (Ibs a.i./A) * fraction a.i. retained on soil (1.0/cm) * 4.54E+8 /ig/lb * 2.47E-8 A/cm2 * 0.67 cmVg soil]
b Ingestion rate: g/day for granular ingestion, and mg/day for incidental soil ingestion.
0 Average daily dose (ADD) (mg/kg/day)
Granular ingestion: = [F * IgR (g/day) * 1,000 mg/g] / [BW (kg)]; and
Incidental soil ingestion: = [SRI (//g/g) * IgR (mg/day) * g/1,000,000 //g] / [BW (kg)].
d MOE = LOAEL (200 mg/kg/day) / ADD.
d.
Cumulative Effects
Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that have
a common mechanism of toxicity." The Agency believes that "available information" in this context
might include not only toxicity, chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and conducting cumulative risk
assessments. For most pesticides, although the Agency has some information that may be used for
determining whether a pesticide shares a common mechanism of toxicity with any other substances,
EPA does not at this time have the methodologies to resolve the complex scientific issues concerning
common mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this
issue further through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot process will increase the Agency's scientific understanding of this question such
that EPA will be able to develop and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative effects of such chemicals. The
Agency anticipates, however, that even as its understanding of the science of common mechanisms
increases, decisions on specific classes of chemicals will be heavily dependent on chemical specific
data, much of which may not be available at present.
The Agency is examining whether and to what extent some or all organophosphate and
carbamate (including, but not limited to, methyl carbamate, N-methyl carbamate, thiocarbamate, and
di thiocarbamate) pesticides may share acetyl cholinesterase inhibition as a common mechanism of
toxicity. In contrast to the methyl and N-methyl carbamates, the Agency has a less fully developed
understanding of whether the thiocarbamates share acetyl cholinesterase inhibition as a common
mechanism of toxicity with other cholinesterase-inhibiting chemicals. While current data are limited,
the thiocarbamates appear to be comparatively weak cholinesterase-inhibitors and are generally
regulated based on other toxic endpoints. As a result, the Agency has not determined if it would be
appropriate to include them in a cumulative risk assessment with other such chemicals (e.g., the
organophosphate and carbamate pesticides) [see the August 31, 1999, EPA Memorandum entitled
September 1999 Meeting of the FIFRA Science Advisory Panel: Working Documents for the Session:
"Proposed Guidance for Conducing Cumulative Hazard Assessments for Pesticides that Have a
37
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Common Mechanism of Toxicity" and "The Car hamate Pesticides and the Grouping of Carbamate
with the Organophosphate Pesticides"}. Also see 40 CFR section 180.3(e)(5), which presents the
Agency's initial grouping of chemicals that would be considered together for the purpose of tolerance
reassessment. This grouping includes some carbamate pesticides but not thiocarbamate pesticides
as members of the class of acetyl cholinesterase-inhibiting compounds.
In September 1999, the Agency presented a paper (cited above) on the common mechanism
of toxicity of the carbamate pesticides to the SAP. In that presentation, the Agency noted that
although various classes of compounds may inhibit acetyl cholinesterase, the potency, reversibility,
and related factors may influence whether or not related pesticides should be included in a cumulative
risk assessment. The Agency is currently awaiting a report from the SAP.
At this time, the Agency does not believe it has sufficient reliable information concerning
common mechanism issues to determine whether EPTC, a thiocarbamate, shares a common
mechanism of toxicity with other cholinesterase-inhibiting chemicals. Therefore, for the purposes of
this tolerance reassessment, the Agency has assumed that EPTC does not share a common mechanism
of toxicity with cholinesterase-inhibiting chemicals.
e. Aggregate Risk Assessment
Aggregate exposure assessments for EPTC consist of dietary exposure (food and drinking
water routes) and residential exposure (dermal for homeowner applicators, and incidental oral
exposure for toddlers resulting from hand-to-mouth behavior.) Aggregate risk assessments were
conducted for acute (1 day), short-term (1-7 days), and chronic (lifetime) exposure.
Acute Aggregate Risk
Acute aggregate risk estimates do not exceed the Agency's level of concern. The aggregate
acute dietary risk estimates include exposure to EPTC residues in food and water and does not
include dermal and incidental oral exposure. Exposure (food only) to combined residues of EPTC
and its metabolites of toxicological concern based on an upper-bound analysis using tolerance-level
residues and assuming 100% of crop treated, represents 87.5% of the acute PAD for the most highly
exposed population subgroup (children 1-6 years). Exposure to all other groups represents less than
62.4% of the acute PAD. Using conservative screening-level models, the estimated maximum peak
concentrations of EPTC in surface water is 57 //g/L. This estimated peak concentration is less than
the Agency's drinking water level of comparison for exposure to EPTC in drinking water as a
contribution to aggregate acute dietary risk. Based on the available information, the Agency
concludes with reasonable certainty that no harm to any population will result from acute dietary
exposure to EPTC.
Short-Term Aggregate Risks
Short-term aggregate risk estimates do not exceed Agency's level of concern. Short term
aggregate risk estimates for adults include exposure to EPTC residues in food, water, and high-end
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exposure estimates for non-occupational use in residential settings (applying granules by hand/spoon).
Although short-term dermal and inhalation exposures are anticipated during handling and applying
EPTC, the endpoint effect selected for inhalation risk differs from the endpoint effect selected for
dermal and oral risk. Therefore, the inhalation route of exposure does not contribute to the aggregate
risk estimate. Short-term aggregate risk estimates for infants/children include exposure to EPTC
residues in food, water, and from inadvertent oral soil ingestion resulting from hand-to-mouth
behavior.
In the case of EPTC, the doses, endpoints, and uncertainty factors selected for short-term
dermal and non-dietary inadvertent oral exposure are the same as those selected for the acute dietary
oral (food and water) exposures. Thus, calculation of the short-term DWLOC is as follows:
Solving for the short-term (ST) water exposure and the DWLOcs f°r infants/children and adults, we have:
Where, the Acute PAD = 0.067 mg/kg/day, given the information above on exposure, then
Adult Male Short-term water exposure = 0.067 mg/kg/day - [(0.00026769 + 0.04) mg/kg/day] = 0.026731 mg/kg/day
DWLOCS = [0.026731 mg/kg/day x 70 kg bwt] -f- [2 L/day x 1 E-3 mg/,ug] = 937 //g/L (ppb)
Children 1-6 Short-term water exposure = 0.067 mg/kg/day - [0.000516 +0.0003 mg/kg/day = 0.066315 mg/kg/day
DWLOCS = [0.066234 mg/kg/day x 10 kg bwt] -f- [1 L/day x 1 E-3 mg///g] = 663 ng/L (ppb)
As shown in the following table, the drinking water estimated concentrations in both ground
water (Sci-Grow estimated 1.84 //g/L) and surface water (PRZM-EXAMS estimated 3.44 //g/L
annual average) are below the Agency's DWLOCs for EPTC for all populations. Therefore, there
are no concerns for short-term aggregate exposure.
Table 15. Drinking Water Levels of Comparison for Short-term Aggregate Exposure
Population
Adult Male
Adult Female
Children 1-6
PRZM-
EXAMS
(Mg/L)
3.44
3.44
3.44
SCI-
GROW
(Mg/L)
1.84
1.84
1.84
aPAD
(mg/kg/day)
0.067
0.067
0.067
Average Food
Exposure
(mg/kg/day)
0.000231
0.000229
0.000435
Residential
Exposure
(mg/kg/day)
0.04
0.04
0.0003
Water
Exposure
(mg/kg/day)
0.026769
0.026771
0.066315
DWLOC,hort
term
(Mg/L)
937
803
663
Chronic (Non-Cancer) Aggregate Risk
Chronic (non-cancer) aggregate risk estimates do not exceed the Agency's level of concern.
The aggregate chronic dietary risk estimates include exposure to EPTC residues in food and water.
No chronic residential use scenarios were identified. Exposure (food only) to combined residues of
EPTC and its metabolites of toxicological concern, based on a Tier 3 refinement using average
residues from field trial and percent of crop treated data, represents 17.4% of the chronic PAD for
the most highly exposed population subgroup (children 1-6 years).
Exposure to all other groups represents less than 14.8% of the chronic PAD. Using
conservative screening-level models, the estimated maximum mean of annual means of EPTC in
39
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surface water is 3.44 //g/L. This estimated average concentration is less than Agency's drinking
water level of comparison for exposure to EPIC in drinking water as a contribution to aggregate
chronic dietary risk. Based on the available information, the Agency concludes with reasonable
certainty that no harm to any population will result from chronic dietary exposure to EPIC.
C. Environmental Assessment
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
Birds
EPIC is essentially non-toxic to birds on an acute basis. In all acute and subacute tests, little
or no mortality occurred at the highest test levels. Therefore, for risk assessment purposes, acute risk
will be assessed using either an LD50 of >2,510 mg/kg (for granular formulations) or a dietary LC50
of >5,280 ppm (for spray formulations).
It is assumed that if exposure does not approach or exceed levels at which little or no
mortality occurred, acute lethal effects are unlikely.
No chronic toxicity data are available for birds. However, because EPIC may be applied
more than once per season, avian reproductive testing is required.
Mammals
EPTC does cause some acute lethal effects to mammals, with LD50 s ranging from 916 mg/kg
and up. The LD50 of 916 mg/kg is used to assess possible acute lethal risks to mammals from
granular uses.
To assess acute risk from sprays, the mammalian acute oral LD50 is used to estimate a 1-day
LC50 in ppm dietary concentration. This estimation takes into account how much a mammal eats in
one day which is expressed as a proportion (percent) of body weight. The following formula is used:
1-day LC50 (ppm) = LD,n (mg/kg)
proportion of body weight consumed per day
For example, if a small mammal (15 gram or 0.015 kg) is assumed to eat close to its body
weight per day (i.e. 0.95 [95% of its body weight), the 1-day dietary LC50 would be: 916 (LD50 in
mg/kg) 70.95 (proportion body weight consumed) = 964 ppm (1-day dietary LC50)
This value represents the concentration that would have to be in the diet of a mammal in order
to achieve the LD50 of 916 mg/kg within one day of eating. This 1-day LC50 is then compared to
estimated maximum dietary residues in the field. If estimated residues exceed /^ (0.5) the 1-day LC50,
the Agency assumes there is a high possibility of acute risk to mammals.
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Using a food consumption factor of 0.95 yields a relatively conservative estimate of a 1-day
LC50, and larger animals that eat a lower proportion of their body weight per day would have
proportionately higher 1-day LC50 values. For example, using the same LD50, a mammal that
consumes 15% of its body weight per day, would have a calculated 1-day LC50 of approximately
6,100 ppm. 916 (LD50 in mg/kg) / 0.15 (proportion of body weight) = 6,107 ppm (1-day dietary LC50).
To assess acute risk from granular formulations, the LD50 is compared with the mg a.i./square
foot. If the mg a.i./square foot exceed 1A the LD50 for an individual, the Agency assumes there is a
high potential for acute risk. In the calculation shown above, the LD50 for a 15 gram mammal was
estimated to be about 14 mg/animal (16 mg/kg X 0.015 mg animal = 13.7mg/animal).
To assess sublethal risk to mammal, the rat 2-generation reproduction study is used. The
results showed no reproductive effects or lethality at the highest test level of 800 ppm. However,
there were sublethal effects to the adult rats at 200 ppm. The effects were reduced body weight and
degenerative cardiomyopathy. While these are not reproductive effects, they are effects that could
result in adverse impacts to individuals in the field. Therefore, for assessing potential for sublethal
risks to mammals, a NOAEL of 50 ppm will be used.
Beneficial Insects
The LD50 for bees is >12.09 ug/bee. Since the LD50 s are greater than 11 ug/bee, EPTC is
relatively non-toxic to bees on an acute contact basis.
b. Toxicity to Aquatic Animals
EPTC is slightly toxic to fish, with LC50 s from several tests ranging from 14 ppm to 27 ppm.
The LC50 of 14 ppm will be used to screen for possible acute risks to fish.
EPTC is moderately toxic to aquatic invertebrates, with EC EC50 s ranging from 6.5 ppm to
66 ppm. The EC EC50 of 6.5 ppm will be used to screen for possible acute risks to aquatic
invertebrates.
While there are adequate data to assess the potential for acute risk to fish and aquatic
invertebrates, there are no chronic data for either fish or invertebrates. These tests are required, since
EPTC is applied more than once per season and is likely to get into surface water
Furthermore, many EPTC uses are in coastal counties, resulting in potential exposure to
marine species. Testing with marine fish, shrimp, and mollusks is required.
c. Toxicity to Terrestrial Plants
Ten species (four monocot and six dicot species) were tested in two kinds of terrestrial plant
tests; vegetative vigor studies, and seedling emergence studies. The toxicity test results (EC25 and
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EC05) from the most sensitive representative are used to assess risk to terrestrial plants. The EC25 is
used to assess risk to plants in general, and the EC05 is used to assess risk to endangered plant species.
The EC05 is a smaller number than the EC25 and represents a more sensitive endpoint; the goal being
to be more protective of endangered plants than for plants in general.
Usually, the plant species with the lowest EC25 is also the plant species with the lowest EC05.
However, in the case of the EPTC vegetative vigor studies, the plant test yielding the lowest EC25
(winter wheat, EC25=0.22 Ib a.i./acre) did not yield the lowest EC05(EC05=0.087 Ib a.i./acre).
Therefore, to assess possible effects to endangered species, an EC05 from velvet leaf (EC05= 0.023
Ib a.i./acre) was used.
Table 16. Showing the test results for terrestrial plants that are used in this risk assessment.
Species
Wild Oats
(monocot)
Winter wheat
(monocot)
Velvet leaf (dicot)
Test Type / effect
seedling emergence/ phytotoxicity
vegetative vigor/ phytotoxicity
vegetative vigor/ phytotoxicity
EC25lba.i./acre*
0.10
0.22
Not used
EC05 Ib a.i./acre
0.017
Not used
0.023
The vegetative vigor study results, in which foliage of actively growing plants were sprayed
with EPTC doses, are used for assessing risk to plants from foliar exposure (drift) only. The seedling
emergence study results, where seeds are grown in soil which has been treated with EPTC, are used
to assess risk from runoff and drift.
Toxicity to Aquatic Plants
To assess the potential for risk to aquatic plants, the green alga EC50 of 1.36 ppm, and the
duckweed EC50 of 5.6 ppm were used.
2.
Environmental Fate
a.
Environmental Fate Assessment
Soil metabolism and volatilization from soil and water are the most important dissipation
pathways for EPTC in the environment. Because the metabolism and volatilization of EPTC can
occur simultaneously, it is difficult to evaluate them independently. Abiotic hydrolysis, and direct
photolysis and photo degradation are not significant degradation pathways for EPTC on soil.
Although it is suspected that EPTC is degraded microbially in water, data have not been submitted
to confirm this. Environmental fate properties are summarized in table below. The primary
environmental (soil/water) degradates are EPTC-Sulfoxide and dipropylamine.
Possible soil and water degradates( including EPTC sulfoxide (ESO)(3.4% of applied), EPTC
sulfone (2%), N,N-dipropylformamide (1.9%) , dipropylamine (35.7%), and ethanesulfonic acid
(unlabeled fragment- 5.4% radioactivity) were identified in photolysis study determined to be
42
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unacceptable by the Agency due to using a light type (black light) that did not correspond to sunlight
light spectrum. In the terrestrial field dissipation studies, only two degradates were detected in soil
samples: EPTC-sulfoxide, and di-n-propylamine (dipropylamine). EPTC-sulfoxide (ESO) (maximum
= 6% of total residues, 0.36 ppm) was identified in an aerobic soil metabolism study.
Table 17. Summary of key environmental fate properties.
Fate Property
Terrestrial Field Dissipation Half-life
Henry's Law Constant
Aerobic soil metabolism half-life
Anaerobic soil metabolism half-lives
Abiotic and Direct Photolysis
Hydrolysis @ pH 5, 7, 9
Soil/Water Partition Coefficient:Kd/Koc
Value
2 to 18.8 days; mean 8.6 days
1.1 x 10'5 m3 - atm/g-mol @20°C
10.3 to 36.9 days; mean = 24. 17 days (nonlinear)
36.5 to 74.9 days; mean = 58.55 days(ln-transformed)
bi-phasic
1st phase: 12. 7 to 27.7 days
2nd phase: 73.0 to 127 days
31 to 127 days; mean = 73.1 days
Stable
Stable
0.77 to 2.99/136 to 264
A number of submissions by the registrant in addition to open literature have been used to
develop the environmental fate assessment for EPTC. These submissions were reviewed, evaluated
and summarized. The environmental fate data base is incomplete, but is sufficient to allow for an
environmental fate assessment of parent EPTC that generally fits the pattern suggested by the
monitoring data which are available.
Soil metabolism and volatilization from soil are the most important dissipation pathway, for
EPTC in the environment. EPTC is highly volatile (vapor pressure 1.60 x 10~2 mm Hg @ 20°C,
Henry's Law Constant ~1 x 10-5 m^ - atm/g-mol @ 20°C). EPTC is readily lost from the soil by
volatilisation when applied, and is not immediately incorporated into the soil. The rate at which a
chemical volatilizes from th3e soil is affected by any factors, such as soil properties, chemical
properties, and environmental conditions. Microbes attack sites on thiocarbamates which possibly
include the alkyl groups, the amide, and the ester linkages. Results from laboratory tests are
inadequate to determine the relative rates of metabolism and volatilization.
Terrestrial field dissipation studies indicate that EPTC is generally not very persistent with
dissipation half-lives ranging from 2 to 18.8 days (mean 8.6 days). However, since volatilization was
not measured during these field studies, the contribution of volatilization to the dissipation of EPTC
could not be determined. Volatilization appears to be an especially significant dissipation pathway
the first few days after application. Other studies (field and laboratory) that measured the
volatilization of EPTC, with traps, suggested that significant quantities of EPTC were lost through
volatilization. The Agency requires that the registrant submit data to assess volatilization under typical field
use conditions.
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Laboratory tests to measure the aerobic soil degradation (dissipation) rates indicated that
half-lives (In-normal transformed linear regression) of 36 to 75 days, or (DTSOs) or half-lives
(untransformed non-linear regression) of 10 to 37 days. The rate of EPTC degradation decreases
with time. By estimating the degradation rates (or half-lives) for the first or second portions (time)
of the lab studies, the half-lives range from 13 to 28 days, and 73-127 days, respectively. Anaerobic
soil metabolism studies suggest that EPTC is somewhat more persistent under anaerobic conditions
with half-lives of 31 to 127 days.
EPTC has low affinity for binding to soil (Kocs < 264) suggesting a potential to leach.
However, because EPTC generally does not persist long in soils, the potential to leach to ground
water is greatly reduced. Microbial degradation and volatilization are important dissipation pathways,
however, the rate of these processes will decrease with increasing depth below the soil surface.
Limited or no leaching of EPTC was noted in the terrestrial field dissipation studies. Few detections
of EPTC were noted in ground-water monitoring studies. In unaged leaching columns, 9 percent of
applied EPTC was found in leachate of loam and clay loam soils, and 55 and 78 percent were found
in leachate for loamy sand and sandy loam soils, respectively. In aged soil columns, an average of
22% of the parent was detected in the leachate. Less than 0.01 percent of applied radio labeled (^c)
found in the leachate was attributed to degradates. Considering the information available, the Agency
does not believe that significant levels of EPTC will reach ground water.
In a laboratory photolysis study, the identified soil degradates include EPTC sulfoxide (ESO),
EPTC sulfone, N,N-dipropylformamide, dipropylamine, and ethanesulfonic acid. In the terrestrial
field dissipation studies, two degradates were detected in soil samples: EPTC-sulfoxide, and di-n-
propylamine. The fate of the degradates is not considered adequately in this assessment due to
inadequate environmental fate data. However, limited data indicates that the EPTC degradates are
less persistent than the parent. EPTC-sulfoxide was found in an aerobic soil metabolism study to be
no greater than 6% (0.36 ppm) of applied EPTC. In a column leaching study, less than 0.01 percent
of applied radio labeled EPTC in the leachate was a degradate. Several of the field dissipation
studies provide limited information on the degradates ESO (0.23 ppm max) and di-n-propylamine
(0.074 ppm max).
The degradates dropped below the limit of detection (0.01 ppm) by 61 days after application.
The only degradate identified in the anaerobic soil metabolism study was ESO sulfoxide (0.01 ppm).
Half-lives were estimated by the registrant to be 7 and 13-14 days, respectively , for dipropylamine
and ESO. The field dissipation studies, metabolism studies, and the leaching studies suggest that the
EPTC degradates are less mobile and generally less persistent than parent EPTC, since the degradates
represent less than a percent of the applied EPTC. This conclusion is arrived at more from the weight
of evidence rather than any direction measurements. The measurement of soil/water partition (K^)
coefficients for the degradates would provide more certainty.
b. Environmental Fate and Transport Data
The registrant has suggested that the first step in the metabolic breakdown of EPTC in soils
appears to be oxidation to the sulfoxide (ESO). Additional sulfur and carbon oxidation
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(hydroxylation) leads to the formation of dipropylamine. Oxidation of the N-alkyl carbon side chain
is supported by the release of 14CO2 from EPIC, ESO, and the amine. The registrant reports that
others have proposed that a minor pathway in the metabolism is N-alkyl hydroxylation and the
subsequent dealkylation. Sulfoxidation followed by the release of carbamic acid has been proposed
as a major metabolic pathway in soil. The dealkylated products (not detected in registrants studies)
are metabolized to 14CO2 in the soil. In the terrestrial field dissipation studies, two degradates were
detected in soil samples: EPTC-sulfoxide and di-N-propylamine. Hydrolysis, photolysis, and sorption
are not significant dissipation pathways for EPTC.
Degradation
Based upon a limited number of registrant-sponsored studies, EPTC does not appear to be
subject to abiotic hydrolysis, under the conditions of these studies. Therefore, hydrolysis does not
appear to be a significant dissipation pathway for EPTC.
The potential for EPTC to degrade through hydrolysis was determined by the registrant.
Solutions of EPTC (90 ppm) were prepared with bacteria free water buffered at pH 5.0, 7.0, and 9.0.
Aliquots of each solution were transferred to individual tubes, and incubated for 3 0-day s in the dark
at 25°C and 40°C (+ 0.5°C) in water baths . Analytical results at both temperatures and at each pH
showed that no hydrolysis of EPTC (no hydrolytic loss of EPTC) occurred at either temperature or
either pH. Further there was no loss of EPTC in the Aqueous Photolysis Study.
Based upon a limited number of registrant-sponsored studies, EPTC does not appear to be
subject to direct photolysis, under the conditions of these studies. Therefore, direct photolysis does
not appear to be a significant dissipation pathway for EPTC. EPTC was determined to photolytically
stable ("no appreciable disappearance of 14C-EPTC occurred") to photolysis in water, based upon a
study determined to be acceptable and valid by the Agency.
Three studies to ascertain the direct photolysis rate of EPTC in water were submitted to the
Agency. One was determined to be acceptable, one was determined to be supplemental, and the third
was determined to be invalid. EPTC did not photo degrade in sealed quartz tubes when continuously
irradiated with a xenon lamp at 25°C for 13.8 days, in the valid, acceptable study. EPTC accounted
for 94 to 103 percent of the radioactivity in the irradiated samples, and 97 to 100 percent in the dark
controls. The registrant indicated that the 13.8 days of continuous, irradiation with the xenon arc
lamp was equivalent to 33.2 days of natural sunlight. Possible water degradates including EPTC
sulfoxide (ESO)/(3.4% of applied), EPTC sulfone (2%), N,N-dipropylformamide (1.9%),
dipropylamine (35.7%), and ethanesulfonic acid (unlabeled fragment- 5.4% radioactivity) were
identified in a photolysis study determined to be unacceptable by the Agency using a light spectrum
(black light) that did not correspond to natural sunlight.
EPTC was shown to be stable to photodegradation on soil in an acceptable study submitted
to the Agency. Therefore, photo degradation on soil does not appear to contribute significantly to
the disappearance of EPTC.
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Radio labeled (14C)EPTC applied to a loamy soil surface did not photo degrade when
continuously irradiated with a xenon lamp at 25°C for 31 days. Parent EPIC comprised 90.8 to 102
percent, and 83 to 101 percent of the applied radioactivity in the irradiated and dark control samples,
respectively. Most of the radioactivity (> 94.5% of the applied) was extracted from the sample with
acidified methanol. Approximately 0.2 percent was recovered as unextracted, 1.5 percent was
recovered from ethylene glycol and sulfuric acid traps, and 0.34 to 1.3 percent was recovered from
the KOH traps. Material balances were 99.2 to 104 percent of the initial material.
Outstanding Issues
Several questions or points needing additional clarification were identified in the Agency
review. The registrant is required to respond to these items. Issues include why there was essentially
no volatilization radioactivity study, when EPIC is so volatile. A contradiction between the analysis
of some soil properties of the Keeton sandy loam also needs to be addressed.
The Agency determined that the photolysis in air data requirement was not met by the
submission of a scientific publication (Kwok et al., 1992). The study was not long enough (single
sampling); thus, no conclusions about the atmospheric half-life could be made. The study authors
concluded that oxidation by OH" radicals are the dominant atmospheric loss processes, once EPTC
enters the atmosphere through volatilization. Study authors report that there was no atmospheric
decay of gas-phase concentrations in air in the dark over 4 hours. The data indicated that in light
EPTC would have a short atmospheric lifetime of less than 1 day, due to its reaction with OH"
radicals in the atmosphere.
In the atmosphere, EPTC will remain mostly in the vapor phase. Non validated data suggests
that the vapor phase of EPTC degrades rapidly by reacting with photochemically produced hydroxyl
radicals (half-life estimated to be 14 hrs). Physical removal from the atmosphere also occurs through
wet deposition. Thus, EPTC appears to have the potential to be transported offsite via in the vapor
phase, because it was one of a number of pesticides found in more than 25 percent of the rain
samples collected in three watersheds in Minnesota (Minnesota Dept. of Agriculture, 2/24/99
SFIREG Water Quality and Pesticide Disposal Working Committee). The Agency previously also
determined that air photolysis study was not required, at this time, but be placed in reserve, because
the study may be determined to be necessary at a future time.
The registrant conducted several studies to address the aerobic soil metabolism data
requirement. Aerobic soil metabolism of EPTC does not appear to follow the natural log (In)
transformed first-order reaction rate equation (In C(t) = In C0 - kt) very well over the entire study
duration. Instead, it appears to follow a "bi-phasic" pattern. The registrant and the Agency's
scientists previously determined two loss rates (or half-lives) of EPTC using linear regression on In-
transformed data. Thus, the steeply sloping portion of the concentration versus time curve (initial
times) was analyzed separately from the flatter portion (later times) of the curve. The steeper portion
of the curve was defined as the initial phase, and the flatter portion of the curve was defined as the
secondary.
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For this assessment, half-lives and decay rates of EPTC were determined using data from the
entire duration, of each study. The decay rate of EPTC appears to follow pseudo first-order type
kinetics throughout the study duration when nonlinear regression is applied to the untransformed
form of the equation, (C=C0e"kt ) where C0 is the initial concentration, C is concentration, t is time,
and k is the decay rate constant. The parameter k was estimated by non-linear regression of C versus
time. The decay rate constant (k) was also estimated using linear regression on the log-normal
transformed data.
Table 18. Summary of degradation rate constants and estimated half-lives for EPTC in three
soils and upper 90th confidence bounds.
Soil
Keeton sandy loam2
Sorrento loam2
Atterberry silt loam2
Keeton sandy loam3
Keeton sandy loam2
Sorrento loam2
Atterberry silt loam2
Keeton sandy loam3
"Ln-nonnal transformed First-Order" Degradation Rate Constants - k (day "*) (coefficient of
determination) and Half-life (days) for EPTC by phase duration1.
Initial1 [phase duration]
0.0547(0.96); 12.7 [0-3 Id]
0.0250 (0.97); 27.7 [7-3 Id]
0.0324(0.98); 21.4 [7-80d]
0.0254 (0.96); 27.3 [0-63d]
Secondary1 [phase duration]
0.0054(0.98); 127.4 [31-205d]
0.0095(0.98); 73.0 [31-205d]
na4; 60.8
0.0048(0.95); 143 [63-3 14d]
Data from entire duration of study included.
Pseudo First-order
Integrated average
(C(t) = C0exp(-kt)
k (days'1); Half-life (days)
0.067292 (0.96); 10.3
0.018772 (0.96); 36.9
0.030297 (0.99); 22.8
0.026070 (0.93); 26.6
Ln transformed Pseudo !st-order
In C(t) = In C0 - kt
k (days'1); Half-life (days)
0.01 170 (0.63); 59.2
0.01090 (0.95); 63.6
0.01900 (0.93); 36.5
0.00925 (0.79); 74.9
Ratea = mean + ta * (stdA/4)
Rate09 = 24. 17 + 2.353*(10.99//4) = 37.08 days (0.0187 days'1) - Non-linear
Rate09 = 58.55 + 2.353*(16.12//4) = 77.49 days (0.0089 days'1)) - Ln-transformed
1 EPTC initially declined at a faster rate followed by a slower decline rate. The registrant consider the two rate class as phase. Phase duration
represents the period of the study considered in each phase.
2 MRID Numbers 42120805 and 42120806.
3 MRID Number 40420402
4 na - Rate constant provided but appears to be the slope of a line between 2 data only.
Due to differences in soils chemical and physical properties, differences in microbial
populations, and experimental conditions, the degradation of EPTC doesn't result in a unique
degradation (dissipation) rate, but results in a range of values.
The decay rate constants, k, were used to determined the half-lives (rate = In2/half-life) or
DT50. The half-life and DT50 are equivalent when conducting a linear regression on In-transformed
data or non-linear regression on untransformed data, when using the "pseudo" first order kinetics
model. Depending upon which method was used, the half-life values ranged 10.3 to 74.9 days. The
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calculated coefficients of determination were closer to 1.00 for the non-linear regression (0.93-0.99)
compared to the transformed linear regression (0.63-0.95).
The first study was conducted to obtain information on both aerobic and anaerobic soil
metabolism. The same soil (Keeton sandy loam from CA) was used for both "redox" conditions. The
Agency determined that this aerobic soil metabolism study did not satisfy data requirements. Several
recommendations were made as to what information would need to be submitted so that the data
requirement could be fulfilled. This study was determined to provide supplemental information
concerning the metabolism and volatilization of EPTC
The registrant proposed that EPTC degraded and volatilized in aerobic soil at two rates. The
first rate suggested that EPTC degrades rapidly, with a first half-lives of 14 to 21 days (half-life 17
days) (In-normal transformation). A second, slower rate of degradation also was determined to
occurs between 30 and 63 days (half-life 47 days) after 80% of original parent had dissipated was
also suggested. The Agency noted that the data indicates that the aerobic soil half-life of EPTC
would be longer than 17 days. A half-life of 74.9 days was estimated, using all the data, assuming
that the In-normal first-order degradation rate model was correct.
The decay rate of EPTC appears to fit better a pseudo first-order type (C=C0e"kt) relationship
without transforming the data as indicated by the coefficient of determination (r2 = 0.93). The
estimated rate of decline is 0.026068 days"1 (T1/2 = 26.6 days). The half-lives were calculated from
the EPTC residues extracted from soil, and about 45% of the applied radioactivity had volatilized as
parent by day 30. Volatilization was rapid, much of the volatilization occurred during the first seven
days. Although the decline in EPTC soil residues appears to support the reported half-life of 26.6 days,
volatilization contributed more to the initial decline than aerobic soil metabolism (as measured by CO2 and
14CO2 production).
EPTC sulfoxide (ESO) was the only degradate identified by TLC, with the average
concentration reaching its highest value at 14 days (5.6% of applied, 0.33 ppm), and then decreased
to 0.07 ppm (1.2%) at 63 days. In an associated study, the registrant added two degradates of EPTC
(ESO and dipropylamine). The registrant indicated that the apparent half-life values for EPTC,
dipropylamine, and ESO were reported as 22-26 days, 7 days, and 13-14 days, respectively, in the
Bethany soil (stated to be from IL, no other data reported). These results indicate that ESO and
dipropylamine are less persistent than EPTC in the study.
Two additional aerobic soil metabolism studies submitted by the registrant were determined
to be scientifically valid and provide additional information. Half-life values were obtained in a
manner similar to that discussed for the previous study. These studies indicated that EPTC degraded
and volatilized much more rapidly in the first phase (early part of study) in three soils under an
aerobic soil environment. Half-lives ranged from between 12.7 and 27.7 days for the first phase.
Slower rates of degradation (half-lives 60.8 to 127.4) were determined in the second phase (i^s =
0.95-0.98). The EPTC sulfoxide degradate, ESO, was the only degradate identified which never
accounted for more than 6 percent (0.36 ppm) of the total residues.
48
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Half-lives for the three soils included in this study were recalculated by the Agency, using the
pseudo first-order type (C=C0e"kt ) relationship without transforming the data. The regression
equations obtained using nonlinear regression on all the untransformed data had better coefficients
of determination (i^s = 0.96 to 0.99) than the linear regression using In-transformed data (0.63 to
0.95). The recalculated half-lives (or DTSOs) ranged from about 10 to 37 days, using the non-linear
method, and 36.5 to 74.9 day, using In-transformed data and linear regression.
The Agency previously suggested that the aerobic soil half-life of EPTC (17days) may be
longer than reported, because that value combines volatilization and microbial degradation. The
Agency also determined the half-life, by excluding the amount collected in the "traps", to account
for losses from volatilization. The recalculated half-life was 46 days. Although the decline of EPTC
residues in soil was supported by the half-life (rate), volatilization contributed more to the initial
decline than aerobic soil metabolism. Aerobic metabolism may be of secondary importance in the
decline of EPTC from these soils. In these studies, the decrease in EPTC residues was primarily due
to volatilization, since 33 to 81% of applied radio activity was present as volatile parent at end of the
studies. The Agency concluded that volatilization may be an important route of dissipation in the
environment, even with incorporation.
The recommendations on how to make the studies satisfy data requirements were suggested
by the Agency in the data review. The outstanding issues included a contradiction (e.g., %organic
matter) of the analysis of soil properties associated with the Keeton sandy loam.
The registrant submitted two studies to address the anaerobic soil metabolism data
requirement. These studies were determined to be scientifically valid and therefore able to provide
additional information to the Agency. The Agency estimated the half-life as 127 days, and concluded
that the anaerobic metabolism could be quite slow. These data suggested that the volatilization of
EPTC contributed more to the initial decline of EPTC than did the anaerobic metabolism as measured
by CO2 evolution. The second study was also determined by the Agency to be scientifically valid
and adequate to provide supplemental information. The study shows that EPTC degraded and
volatilized in three soils with estimated half-lives of between 31.4 days and 83.6 days. EPTC -
sulfoxide (ESO) was the only degradate identified and never accounted for more than 0.01 ppm
No anaerobic or aerobic aquatic metabolism data have been submitted for EPTC. The Agency
requires that the registrant conduct one or more aerobic and anaerobic aquatic metabolism studies
to support the registered uses of EPTC. This requirement is due to the wide spread use of EPTC,
high application rates, its low soil partition coefficient, and detections (wide spread) in surface water
bodies. The environmental fata data and use profiles suggests that while there is a potential for EPTC
to reach surface water exists, because of degradation and volatilization it is not very persistent in an
aquatic environment. The rate of degradation in water will allow for a better understanding of the
fate of EPTC in water where volatilization is limited (e.g., still water, deep water). This data would
allow for a higher degree of certainty when assessing the fate of EPTC and its degradates on water
quality.
49
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The laboratory volatility study submitted by the registrant was acceptable and satisfied the
data requirements. EPIC (non-labeled @ 99.8% purity and Radio labeled (N-propyl-l-14C-EPTC
@ 99.4% purity and specific activity of 393 dpm/|ig) was added to a sandy loam soil. Volatile EPTC
was collected in foam plugs in the flow through system. Fifty-five percent of the total amount of
EPTC volatilized during the first two hours of the study. The rate of volatilization decreased with
time and was essentially complete within four hours, where about 76 percent of the applied
radioactivity volatilized during this period. The data also indicated that volatility is a potential major
route of dissipation of EPTC in the environment. After 25 hours, the material balance averaged 99.1
percent. Parent EPTC was the only significant residue detected in the foam traps during the study.
The registrant submitted a study conducted by the USDA to address field volatility data
requirement. The Agency reviewed the information and determined that the study partially satisfies
the data requirement. EPTC can be applied through irrigation water, or chemigation. A study
conducted by USDA researchers provides some information about the fate of EPTC when applied
via the flood irrigation of alfalfa (Cliath et al., 1980). The following was reported when EPTC was
applied in the flood-irrigation water. Of the 2.71 Ib/ac applied (average concentration 2170 ppb),
73.6 percent volatilized (2.0 Ib/ac) during the observation period of 52 hours. Seven percent (0.19
Ib/ac, concentrations ranging between 1970 to 1440 ppb during observation period) of the applied
EPTC was removed in the tailwater runoff. This suggests that EPTC concentrations in runoff water
at a treated field edge can exceed 1000 ppb. Of the 73.6 percent measured to be lost through
volatilization, 28.4 percent volatilized from water and 45.2 percent volatilized from wet soil. They
determined that for this experiment, 80.6 percent of the EPTC applied to the alfalfa was lost through
runoff and volatilization. It was concluded that losses could be reduced by reducing the amount of
irrigation water lost as tailwater. These data indicate that volatility is a potential major route of
EPTC dissipation in the environment.
In the atmosphere EPTC will remain mostly in the vapor phase. Non validated data suggests
that the vapor phase of EPTC degrades rapidly by reacting with photochemically produced hydroxyl
radicals (half-life estimated to be 14 hrs. Physical removal from the atmosphere also occurs through
wet deposition. Thus, EPTC appears to have the potential to be transported offsite via in the vapor
phase.
The Agency required additional information on the volatilization of EPTC when it is soil
incorporated in the field. In this assessment it was determined that field data should be submitted
which assesses the volatilization of EPTC under typical use condition.
Mobility
The affinity of EPTC to bind, or sorb, to four soils as reflected by the adsorption (Freundlich
Kads -0.8 to 3.0) and desorption (Kdes -2.1 to 4.8) values appears to relatively low.
50
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Table 19. Summary of four soils: selected soil properties.
Soil
Series
Keeton
Columbia
Sorrento
Atterberry
%sand
64.4
80.2
45.6
17.8
%silt
26.0
14.0
34.0
56.4
%clay
9.8
5.8
20.8
25.8
PH
7.7
7.8
6.8
5.6
%OC'
0.29
1.1
1.8
2.2
CEC
8.5
12.2
20.7
24.6
Mean (of 2)
n2
1.10
1.06
1.04
1.10
Kd(std)
0.77 (0.02)
1.61 (0.04)
2.57(0.07)
2.99 (0.07)
Koc(std)
264(8)
146 (4)
143 (4)
136(3)
1 %OC is Percent soil organic carbon.
2 n term in slope of the sorption isotherm (1/n).
Thus, considering the relatively low measured Kads and calculated Koc values obtained, EPTC
appears to have a medium to high potential for leaching. The percent EPTC in leachate and the Kds
estimated from the column leaching studies also indicated that EPTC has a high potential to leach.
Its susceptibility to volatilization and biodegradation may modify its potential to contaminate ground
water. The rates of volatilization and biodegradation will probably decrease with increasing depth
below the soil surface. Overall, the binding of EPTC appears to be relatively unimportant in the
overall dissipation reactions of herbicide. The Agency One-liner database reports a RF value of 0.56
for the Pel ton sandy loam.
Leaching/Adsorption/Desorption
The registrant conducted a batch equilibrium study to determine the Freundlich (Kads) and
desorption values (Kdes) for EPTC. The four soils considered in the experiment were the Keeton
sandy loam, Columbia loamy sand, Sorrento loam, and the Atterberry silt loam.. The calculated Kads,
assuming the Freundlich isotherm, for the four soils ranged from 0.77 to 2.99 mL/g. The calculated
Kdes for the four soils ranged from 2.08 to 4.76. The n value in the slope term (1/n) ranged from 1.05
to 1.15 for adsorption and desorption phases. EPTC adsorption by these four soils increased as soil
organic carbon increased. Thus, the Koc model appears valid (also statistically significant). For
these, soils the Koc values ranged from 136-266, with a mean of 173. Previously, the Agency
determined that this study was acceptable, and partially fulfilled the EPA data requirement
Leaching of Aged and Unaged
The registrant conducted EPTC aged and unaged leaching column experiments by applying
Radio labeled 14C-EPTC to the soil which was re-packed in soil columns. The study was determined
to be both scientifically valid, and satisfies the data requirements in conjunction with the
leaching/adsorption/ desorption study. Four soil textures (loamy sand, sandy loam, loam, and clay
loam), sieved to 1-mm, were re-packed in columns to a depth of 30 cm with a vibrator. In the aged
leaching study, an average of 22 percent of the applied parent EPTC was recovered in the leachate.
In the study, 9 percent of the applied parent was found in the leachates to the loam and clay loam
soils, and 55 and 78 percent of the parent were found in the leachates of the loamy sand and sandy
loam soils, respectively. In both the aged and unaged leaching columns, less than 0.01 percent of the
applied 14C found in the leachate were degradates (including EPTC sulfoxide). The Kd values
51
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estimated for EPTC in the four soils in this study were 0.38, 0.68, 1.82, and 1.28 for the sandy loam,
loamy sand, loam, and clay loam, respectively.
It was noted by the study authors that total recoveries (mass balance) were low (68.6 and
85.3% of applied 14C). The authors attributed the low recoveries to the volatility of the test
substance. This was determined to be a plausible explanation, since a substantial amount (up to 80%)
of the EPTC volatilized in the aerobic and anaerobic metabolism studies. Also, in the laboratory
volatility study, up to 77 percent of the applied EPTC volatilized after four hours.
Field Dissipation
Nine terrestrial field dissipation studies have been submitted by the registrant and reviewed
by the Agency. These studies were determined to be unacceptable and thus did not meet the 164-1
statutory data requirement. The Agency indicated that some, if not all, the studies could be upgraded.
Until such time that the outstanding issues are addressed, these studies provide supplemental data.
It is was also noted that although some outstanding issues remain to be addressed by the registrant,
the Agency determined that EPTC was not persistent to moderately persistent in soil.
It was also noted that EPTC did not appear to be mobile in soils, even though the Freundlich
Kds were less than 5. However, insufficient water (rain and/or irrigation) may have been applied to
the study plots for significant leaching of EPTC residues to have occurred. These studies indicated
that EPTC had dissipation half-lives of 2 to 56.8 days, with an average half-life of 12.6 days.
However, the two studies were reevaluated. The maximum field dissipation half-life, considering the
reevaluation of the two studies, resulted in a range of values from 2 to 18.8 days, with an average
half-life of 8.6 days.
Several of the studies provide limited information on the degradates EPTC sulfoxide and di-
N-propylamine. The data were not adequate to evaluate the formation and decline of degradates or
their mobility. The registrant will be required to submit data to assess volatilization under typical
field use conditions (e.g., soil incorporated, watered-in, or applied via-chemigation). This will allow
for a quantitative (or semi-quantitative) assessment of the loss of EPTC via volatilization.
ACCUMULATION
Accumulation in Rotational Crops
The Agency database indicates that EPTC in unlikely to accumulate in wheat, sugar beets, and
soybean plants, based on a valid study.
Accumulation in Irrigated Crops
Bioaccumulation of EPTC in Fish: The Agency determined that the studies submitted by the
registrant pertaining to accumulation of EPTC in fish were scientifically valid and provide
supplemental information. Studies showed that [14C]EPTC did not substantially accumulate in
52
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bluegill sunfish exposed to [14C]EPTC at 0.084 ppm in a flow-through system for 28 days. The
bioconcentration factor (BCF) in the flow-through accumulation study was 97X for viscera and 34X
for fillet.
The bioaccumulation and elimination of [14C]EPTC by bluegill sunfish was investigated in a
dynamic flow-through system (Forbis, 1987). The flow system was comprised of two aerated tanks
containing 70 liters of water. The treated tank received the [14C]EPTC (specific activity 3.41 x 109
dpm, 99% radio purity diluted to 1270 dpm/|ig) from a stock solution. The treated and control tanks
received 120 fish. The fish were exposed for 28 days to the Radio labeled material at 22 ±2 oc,
followed by depuration in EPTC free water for 14 days. Fish and water samples were collected after
4-hours, 1, 3, 7, 14, 21, and 28 days after both EPTC-treated water and the EPTC-free water.
Fish were sectioned into edible and nonedible (viscera) portions for analysis. During the
exposure period, tissue concentration in the fillet, viscera, and whole fish increased from 0.6 to 3.1
ppm, 1.9 to 9.2 ppm and 1.7 to 5.0 ppm, respectively. Recovery of [14C]EPTC residues in water,
nonedible, and edible fish tissue at sampling days 21 and 28 were, respectively, 88.6 % and 92.8%,
885 %. and 84.6% and 91.4 %, and 99.7%. Bioconcentration factors were 37X, 60X, and 110X,
respectively, in the edible, whole fish, and non-edible fish tissues. The study did not meet data
requirements because no storage stability data were submitted by the registrant. Fish samples were
frozen and stored up to 7 months before analysis
c. Water Resources
EPTC is capable of contaminating ground water and surface water, because it has been
detected in both media. This section presents a summary of the assessment of the potential of EPTC
to contaminate ground water, surface water, and drinking water from labeled uses. The assessment
includes Tier II (PRZM/EXAMS) estimates of environmental concentrations (EECs) in surface water,
for EPTC applied at the several label rates and numbers of applications to alfalfa, citrus, corn, and
potatoes. These crops represent the major uses and generally reflect the highest use rates and
amounts. Surface-water monitoring data sources available in the EPA's STORET data base and the
USGS National Water Quality Assessment Program (NAWQA) were also considered.
The potential for EPTC residues to contaminate ground water was assessed using the
ground-water concentration screening model (SCI-GROW) and monitoring data available in the
Agency's Pesticides in Ground Water Data Base (PGWDB), STORET data base, and NAWQA
studies. The purpose of this analysis is to provide an estimate of environmental concentrations of
EPTC in surface water bodies and ground water, for use in the human health and ecological risk
assessment as part of there registration process.
Ground Water
The ground-water monitoring data confirm that EPTC has the potential to contaminate
ground water. The maj ority (more than 90%) of EPTC concentrations in ground water were reported
53
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to be "0" or less than the detection limit (generally < 0.05 |ig/L). With the exception of three data
values, the maximum EPTC concentration reported in the PGWDB, for the NAWQA program, and
the STORE! database were 0.33 |ig/L, 0.45 |ig/L (<2% of the sites had detections), and 0.50 |ig/L,
respectively. Of the three samples where higher ground water concentrations were noted, the first
(2.7 |ig/L) is cited by the USGS and represents ground water at a mixer-loader site.
The remaining two concentration value were reported in STORET for a site in Alabama
(both 1500 |ig/L). There was no statement as to the source of EPTC in the STORET data base, or
an explanation as to why the values were so high. Based upon the environmental fate profile of
EPTC and the other available monitoring data, it is unlikely, if in fact these concentration data are
correct, would be the result of normal agricultural practices. EPTC is mobile in soil as indicated by
Kocs ranging from 136 to 266 mL/g. EPTC does not appear to be persistent, under most conditions,
but where microbial degradation is inhibited or volatilization is restricted, EPTC could be persistent.
Surface Water
Surface-water monitoring data confirm that EPTC contaminates surface water bodies. The
frequencies (4 to 25%) of reported EPTC detection in surface water depended on type of site or
water body sampled, and were greater than frequencies of detection (0 to 2%) in ground water
sampled in NAWQA or reported in STORET. The states with the highest frequencies of detection
in surface water correspond with the regions with greatest EPTC use. Maximum EPTC
concentrations in NAWQA depended on site type (stream, lake), and ranged from 0.037 to 40 |ig/L
(the maximum value, 40 |ig/L, was outside the range of the method calibration). In the STORET
database, concentrations in surface water ranged from 0.001 to 10.0 jig/L (streams 0.0 to 10.0 jig/L,
lakes 0.005 to 0.09|ig/L).
EPTC is used in most regions of the United States on a variety of crops with different
application rates and methods, application intervals, and total amounts permitted to be applied. Tier
II surface water modeling was conducted for EPTC, on several major crops at high exposure sites,
using the EPA's PRZM and EXAMS models. The crops modeled were alfalfa, beans, citrus, corn,
and potatoes. They were selected from label information, because they generally represent the
maximum application rates, number of applications, and the maximum total amount applied. Lower
concentrations were predicted for those scenarios having the lowest application rates and the fewest
number of applications.
PRZM/EXAMS output consists of an estimated daily concentration in a standard water body.
For each scenario, the annual peak value is highest daily concentration in a year, thus, there are 36
peak values. These values are sorted (maximum to minimum) and the 90tn percentile value is
selected (l-in-10-year). The range of the 9Qth percentile peak EECs, for a number of scenarios was,
3.67 to 41.69 ppb. The other EECs represent the 9Qth percentile of the running mean over a
specified period of time (i.e., 96-hour, annual). The ranges for ten scenarios of the l-in-10-year, or
90tn percentile, for the non peak EECs were 96-hour (3.43 to 39.33 ppb), 21-day (2.82 to 31.16
ppb), 60-day (1.76 to 20.56 ppb), 90-day (1.33 to 16.72 ppb), and annual means (0.37 to 3.44 ppb).
54
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The range of the 9Qth percentile upper bound of the means of the annual mean of daily values for the
ten scenarios was 0.19 to 3.8 ppb. In general, the lowest EECs were generated for beans and corn,
whereas the highest EECs were for citrus.
Drinking Water
The range of peak EPTC EECs (6.35 to 57.35 |ig/L) generated by PRZM/EXAMS, for the
ten scenarios, corresponds reasonably well with the range of highest surface water concentrations of
EPTC observed (without considering data limitations or modeling short comings) in the STORET
andNAWQA (10 to 40 |ig/L). The 9Qth percentile upper-bound EPTC value for the means of annual
means of the daily EECs ranged from 0.19 to 3.80 |ig/L. Monitoring for EPTC has been conducted,
in at least thirty states. The range of the means for the ten scenarios was 0.15 to 3.44 |ig/L. The
monitoring data indicates that EPTC concentrations in surface water are generally very low (generally
less than 0.05 |ig/L, but rarely greater than 1 |ig/L). However, EPTC concentrations in surface
water have occasionally been detected at levels up to approximately 40 |ig/L. The EPTC EECs are
suggested based upon the evaluation of both the monitoring data and modeling results.
For surface water, monitoring data rarely exceeded (or reached) 10 |ig/L), and the peak EECs
generated from the modeling were similar in magnitude.. The environmental fate data indicates that
EPTC would not be persistent under many environmental conditions, an observation supported by
relatively short half-lives observed in terrestrial and aquatic environments.
Monitoring data suggests that concentrations of EPTC in ground water will be less than those
found in surface water. However, its persistence in ground water would probably be greater than in
surface water, since losses due to volatilization would be expected to be much less. SCI-GROW
estimates provide a Tier 1 screening level estimate of ground-water concentrations. The value
represents an estimate of chronic exposure for ground water (long term average rather than peak)
under vulnerable conditions. The predicted values by SCI-GROW (1.84 and 5.89 |ig/L) are generally
greater than those observed in the monitoring data, but are of similar order of magnitude as the
maximum values observed in monitoring (<0.50 |ig/L). It is recommended that 2 |ig/L and 0.5 |ig/L
be used as the estimates of acute and chronic drinking water levels for ground water. The acute and
chronic values for ground water are selected for essentially the same reason that the surface water
values were selected.
3. Exposure and Risk Characterization
The focus of this ecological risk assessment is risk to mammals and terrestrial plants. The
risk to other organisms is either negligible, or cannot be assessed with available data. Risk was
assessed for uses that represent the full range of application rates. Risk was assessed for use rates
ranging from 3 Ib a.i./acre (corn, beans and alfalfa) up to 15 Ib a.i./acre (ornamentals). The
ornamental use was included because it has an exceptionally high application rate, not because it
represents a significant usage of EPTC. For birds, fish, and invertebrates, peak rates and exposures
were used to show that there was no risk (acute data only; chronic data are lacking). For mammals,
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risk quotients for only 3 application rates are presented (3, 6 and 15 Ib a.i./acre), since these
represented the full range of uses of EPIC. For terrestrial plants, risk quotients are presented for
rates ranging from 3 to 6 Ibs a.i./acre. Risk to terrestrial plants from the ornamental use, at 15 Ib
a.i./acre, is discussed, but risk quotients for terrestrial plants are not calculated because of the high
uncertainty in estimating runoff from that usage.
There are some risks that cannot be assessed with available data. Since avian reproduction
test results are not available, potential sublethal or reproductive effects to birds cannot be assessed.
EPTC does cause sublethal effects to mammals at expected exposure levels, so it is important that
avian reproduction testing be conducted. EPTC is expected to reach water repeatedly due to multiple
applications. However, chronic testing results are not available for fish or invertebrates. These tests
would be of value to determine if EPTC causes sublethal or reproductive effects to freshwater
organisms which may affect aquatic populations.
EPTC is also used on crops that are grown in coastal counties. However, acute test results
with estuarine fish, shrimp and mollusks are not available, so risk to these organisms cannot be
assessed. The freshwater organism testing suggests that EPTC is not particularly toxic to aquatic
organisms in general. However, estuarine species can be more sensitive than freshwater organisms,
so acute tests with these organisms would be valuable. Reproductive testing with shrimp is also
required. The chronic estuarine fish study is reserved.
a. Ecological Exposure and Risk Characterization
Exposure to Terrestrial Animals
Since EPTC is applied as a spray, a granular, and by chemigation, three different methods are
used to estimate exposure to terrestrial animals.
To assess maximum exposure to terrestrial animals from sprays, the application rate in Ib
a.i./acre is multiplied by environmental concentrations in the nomograph, as shown below.
Table 20. Estimated Environmental Concentrations on Avian and Mammalian Food Items (ppm)
Following a Single Application at 1 Ib a.i./A
Food Items
Short grass
Tall grass
Broadleaf/forage plants
Fruits, pods, seeds2
EEC (ppm) Predicated Maximum Residue *
240
110
135
15
EEC (ppm) Predicted Mean ' Residue
85
36
45
7
Predicted maximum and mean residues are for a 1 Ib a.i./a application rate, and are based on Hoerger and Kenaga (1972) as modified by
Fletcher et al. (1994).
Residues on insects may be similar to that which occurs on forage, small seeds and fruits; however, neither Hoerger and Kenega nor Fletcher
obtained residue data on insects.
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The maximum residues are shown in the following table. For example, if EPTC is sprayed at 6.1
Ibs a.i./acre, the maximum residues likely on any terrestrial food items would be approximately 1,464
ppm.(6.1 (Ibs a.i./acre) X 240 (ppm after 1 Ib a.i./acre) = 1,464 ppm). For some uses, EPTC may be
applied more than one time per season. However, because of its volatility, it is expected to dissipate
between treatments, such that subsequent applications will not result in buildup on terrestrial food
items over time. So, for a given application rate, the same maximum exposure concentration is
assumed to occur whether EPTC is applied once, or several times per year.
Table 21. Estimated maximum residues on terrestrial animal vegetative food items in ppm at the rates
shown. Rates shown represent the maximum, or close to maximum, label rates.
Vegetation type
short grass
tall grass
broad leaf
seeds, small fruit
Application rate of 3 Ib a.i./acre:
beans, alfalfa
maximum
720
330
405
45
mean
255
108
135
21
6.1 Ibs a.i./acre:
potatoes, nonbearing citrus, corn
maximum
1,464
671
823
9
mean
518.5
219
274
42
15 Ibs a.i./acre:
ornamentals
maximum
3,600
1650
2025
225
mean
1,275
540
675
105
To assess exposure from granular formulations, the Agency calculated the mg of active
ingredient in a square foot. This calculation takes into account the fact that EPTC granular
formulations must somehow be soil incorporated to be effective. Thus, only a percentage of what
is applied is assumed to be available to terrestrial animals. This is done using the following formula:
mg a.i./square foot = application rate in Ibs a.i./acre X number of mg/pound X percent available
number of square feet in one acre
The mg a.i./sq ft are shown in the table 19. For a granular application of 6 Ibs a.i./acre, there
would be approximately 9.4 mg a.i./square foot.
(6 (Ibs a.i./acre) X 453,590 (mg in a pound) X 0.15 (15% available after incorporation) = 408,231
mg /acre 408,231 (mg/acre) / 43,560 (square feet per acre) = 9.37 or 9.4 mg / sq foot).
Table 22. Estimated mg a.i./square foot following granular applications of EPTC at the rates
shown*.
Application
Rates/Crops
Corresponding
coverage
3 Ibs a.i./acre:
com
4.7 mg/sq ft
4 Ibs a.i./acre: beans,
alfalfa, nonbearing citrus
6.24 mg/sq ft
6 Ibs a.i./acre: potatoes
9.4 mg/sq ft
15 Ibs a.i./acre:
ornamentals
23 mg/sq ft
* Rates shown represent the maximum label rates. In each case, soil incorporation is assumed such that only 15% of the applied
remains on or near the surface.
To determine exposure to birds and mammals from application through chemigation, the
Agency attempted to estimate the likely concentration of EPTC in the chemigation water, as shown
in table in the following table.
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Table 23. Assessment of concentrations of EPTC in chemigation water
Crop
Com
Potatoes
Beans
Alflafa
Application rate (Ib
a.i./acre)
6.1 in 0.5" to 0.75"
chemigation
3.1 to 6.1
3.1 to 3. 9
2 to 4
Concentration
53 ppm to 35 ppm
probably similar to com
probably less than com
2.17 ppm
Comment on estimation
1 Ib a.i./acre in 0.5"= 8.8 ppm 1 Ib a.i./acre in 0.75"=5.8
ppm 6.1 x 8.8 = 53. 7 ppm 6.1 x 5.8 = 35.8 ppm
uncertain because amount of water was unspecified
uncertain because amount of water was unspecified, but
rate per acre is lower than corn
measured cone in sprinkler system, Claith et al. (1980)
Initially, the predicted maximum residues are compared to the toxicity thresholds to determine
if risks are likely. If risks are likely, they are further discussed in the risk characterization. In the
case of EPTC, acute risks to birds are considered unlikely, however, mammals may be at risk as
identified in the risk discussion below.
Exposure and Risk to Birds
To assess acute exposure and risk of EPTC to birds, the Agency used two methods; one for
spray applications, the other for granular applications. Note that since chronic testing with birds was
not available, only acute risk can be assessed.
Spray Formulations
For spray applications, the upper limit concentrations on food items are compared to the
dietary LC50. If these upper limit concentrations on food items fail to exceed levels that were not
lethal in the laboratory, the Agency concludes acute risk is unlikely.
The maximum residues on avian food items from major EPTC uses is not expected to exceed
1,464 ppm (6.1 Ib a.i./acre sprayed on vegetation in treated areas). The maximum residue on food
items from any EPTC use is not expected to exceed 3,600 ppm (ornamental use of 15 Ib a.i./acre
sprayed on vegetation). These residue levels are well below the concentration which, in the
laboratory, caused little or no acute effects (5,280 ppm).
Granular Formulations
Possible risk to birds from granular formulations is determined by comparing the acute oral
LD50 for a wild bird with the number of milligrams active ingredient likely to occur in a square foot.
If the milligrams in a square foot exceed the 0.5 of the LD50, there is a high possibility of acute risks.
In the case of EPTC, the LD50 for birds is determined to be greater than 2,510 mg/kg. This translates
to a dose of about 500 mg for a 200 gram bird (2,510 mg/kg X 0.2 kg = 502 mg). Assuming only
15% of the granules that are applied remain on the surface (i.e. to which birds may be exposed), the
number of mg per square foot EPTC from the maximum granular application rate for a major usage
of EPTC would be approximately
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9.4 mg a.i./foot2 = 6 Ibs ai/A X 453.590 ppm X 15%exp. = 9.4 mg/ft2
43,560 ft2/'A
This is well below the dose level 502 mg at which little or no acute effects are expected.
Therefore, acute risk to birds is not expected from maximum exposure from spray or granular
formulations of EPTC.
Exposure and Risk to Mammals
EPTC is a risk to small mammals. Mammals are at risk from both acute effects and
subchronic effects. The risk quotients are presented below; please see the following sections for
further discussion of acute and sublethal risks to mammals.
Acute Risk to Mammals from Granulars
Table 24. Estimated mg ai/square foot following granular applications of EPTC at the rates shown and the
associated risk quotients (LD50 s per square foot) based on an LD50 of 14 mg/animal (for a 15 g mammal).
3 Ibs at/acre: corn
4.7 mg/sq ft
RQ 0.3
4 Ibs at/acre: beans, alfalfa,
nonbearing citrus
6.24 mg/sq ft
0.4
6 Ibs at/acre: potatoes
9.4 mg/sq ft
0.6
15 Ibs at/acre: ornamentals
23 mg/sq ft
1.6
0.5 = LOG for potentially high acute risk
0.2 = LOG for possible restricted use
0.1 = LOG for possible effects to endangered mammals
Rates shown represent the maximum label rates. In each case, soil incorporation is assumed
that mammals are only exposed to the 15% that remains on or near the surface.
Granular application rates of around 6 Ib ai/acre or higher may represent a risk of acute effects
to mammals. Endangered mammal species may be affected at granular application rates of 3 Ib ai/acre
or higher. Note that this calculation was based on an LD50 for a small (15 gram) mammal. Other
larger mammals would have larger LD50 s, and would be at less risk. For example, a 100 gram (0.1
Kg) mammal would have a LD50 of approximately 92 mg/animal (916 X 0.1=91.6). Even at the
highest application rate, the high acute risk LOG is not exceeded for this size mammal.
EPTC treated clay particles are very small. Analysis of the number of particles that need to
be consumed to exceed l/2 the LD50 suggest that risks to mammals by this route of exposure are
unlikely.
Acute Risk to Mammals from Sprays
All registered spray uses of EPTC represent a risk of acute lethal effects to small mammals
and may affect small endangered mammals. Without adequate mitigation measures EPTC could
potentially become a candidate for restricted use, based on acute risk to mammals. Larger mammals
(for example: a one kg mammal) that eat proportionately less of their body weight per day would be
at less risk.
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Table 25. Estimated risk quotients to mammals feeding on terrestrial animal vegetation at the rates shown
represent the maximum label rates. All LC50s extrapolated} from rat LD50 of 916 mg/kg
Risk quotient (RQ**) = EEC/LC50
EEC range (ppm)
RQs(LC50t=964ppm)0.015 Kg herbivore
RQs (LC50t=1390ppm)
0.035 Kg herbivore eats 66% body wt
daily
RQs(LC50t=6100ppm) 1.0
Kg herbivore eats 15% body wt daily
0.5 = LOG for potentially high acute risk
Application rate of 3 Ib
at/acre: beans, alfalfa
maximum
45-720
0.04-0.7
<0. 1-0.5
<0. 1-0.1
mean*
21-255
0.02-0.2
<0. 1-0.1
0.1-0.1
0. 1 = LOG for possible effects to endangered mammals
6.1 Ibs at/acre: potatoes,
nonbearing citrus, corn
maximum
91-1,464
0.09-1.5
<0.1-1.0
<0. 1-0.2
mean*
42-518
0.04-0.5
<0. 1-0.3
0.1-0.1
15 Ibs at/acre:
ornamentals
maximum
225-3,600
0.2-3.7
0.1-2.5
<0. 1-0.5
mean*
105-1,275
0.1-1.3
<0. 1-0.9
<0. 1-0.2
1 1-day LC?0=LD?0 (mg/kg) X body wt (Kg) X 100 (%)
mg/kg food % body wt eaten daily X body wt (Kg)
* Mean EECs assuming maximum application rate.
"Compare RQs with LOCs
There are risk to small herbivores (0.015 kg) which ingest 95% of their body daily. The risk
to larger herbivores (0.035 kg ingesting 66% of body weight, and 1kg ingesting 15% of body weight
are only of concern at the maximum rate for 3 Ibs a.i./a, and at mean and maximum for 6.1 and 15
Ibs a.i./a.
Acute Risk from Chemigation
The concentration of EPTC in chemigation water is not expected to be high enough to cause
acute risk to mammals or birds.
Sublethal Risk to Mammals
Please refer to the previous table showing the range of maximum and mean residues on
mammal food items. Essentially all spray uses of EPTC result in residues greater than the NOAEL
of 50 ppm, and therefore represent a potential for sublethal risks to mammals. Even mean residue
levels from maximum application rates exceed the NOAEL by sizeable margins. The endpoint for
the 50 ppm NOAEL is based on reduced body weight of the adult rat, and damage to the heart
muscle. There were no reproductive effects evident in the study at the highest test level of 800 ppm.
Thus, whatever effects were occurring to the individual adult rats did not seem to affect their
reproduction.
The estimated concentration of EPTC in corn chemigation water may reach 54 ppm, assuming
0.5 of an inch of water into which 6.1 Ib ai/acre are mixed. This barely exceeds the mammal chronic
NOAEL of 50 ppm.
Exposure and Risk to Aquatic Animals and Plants
Refined aquatic exposure modeling resulted in a maximum peak concentration of 0.04 ppm.
This is far lower than the lowest fish LC50 (14 ppm), the lowest aquatic invertebrate EC50 (6.5 ppm),
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the EC EC50 for alga (1.36 ppm), and the EC EC50 for the aquatic vascular plant, duckweed (5.6
ppm). This indicates the EPTC is unlikely to have acute (i.e. lethal) effects on aquatic animals or
plants.
Exposure and Risk to Terrestrial Plants
Being a herbicide, EPTC is observed to be a risk to terrestrial plants. Non-target plants are
exposed to EPTC moving off the treatment site by spray drift, and surface water runoff. Monitoring
studies in Minnesota found that more than 25 percent of rainfall samples contained EPTC.
Exposure to Terrestrial Plants
Exposure is estimated for two kinds of terrestrial plants; plants growing in upland soils (dry
habitats), and plants growing in wetland soils (wet habitat). Both kinds of terrestrial plants may be
exposed to EPTC from movement offsite in the form of spray drift and/or runoff.
Since EPTC sprays are only applied by ground equipment, movement offsite due to drift is
assumed to be relatively low (approximately 1% of the applied). So in the following equations, if the
method of application is a spray, the amount of drift added to the exposure is 1% of the application
rate.
In addition to considering where plants grow, exposure must be estimated to compare with
results from two kinds of plant tests; the vegetative vigor study, and the seedling emergence study.
The vegetative vigor study involves exposing only the foliage of actively growing plants. The only
route of exposure that is assumed to reach the foliage of plants is that which moves off-site as spray
drift. The seedling emergence study involves treating the soil in which seedlings grow. Both spray
drift and runoff are assumed to reach off-site soil.
Table 26. Which route(s) of ex
Study
Vegetative vigor:
EC25 (nonendangered plants) and
EC05 (for endangered plants)
Seedling emergence:
EC25 (nonendangered plants) and
EC05 (for endangered plants)
posure are compared with which test endpoints.
Plants growing in upland (dry) soils
Spray drift only (in the case of granular
formulations, no offsite foliar exposure is
expected)
Spray drift (except for granular formulations)
+ sheet Runoff
(see equation #1 below)
Plants growing in wetland soils
Spray drift only (in the case of granular
formulations, no offsite foliar exposure is
expected)
Spray drift (except for granular formulations)
+ channelized runoff
(see equation #2 below)
Runoff to plants growing in upland soils is assumed to closely resemble 'sheet runoff,' in
which unchannelized water moves from a 1-acre treated site to an immediately adjacent 1-acre site.
The following equation is used to estimate this exposure:
equation #1: exposure (Ib ai/acre) = (appl rate (Ib ai/acre) X % runoff) + drift
5 cm (depth of soil incorporation)
Runoff to plants growing in wetland soils is assumed to be channelized runoff, in which water
from a treated field (approximately 10 acres) channelizes, and drains into a lowland habitat, thus
exposing plants growing there. The following equation is used to estimate this exposure:
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equation #2: exposure (Ib a/acre) = (appl rate (Ib ai/acre) X 10 (acres') X % runoff) + drift
5 cm (depth of soil incorporation)
Table 27. The percent (%) runoff used in the equations is based on the solubility of the
chemical, using the following criteria.
Solubility
<10ppm
10 to 100 ppm
>100ppm
Percent Runoff
1%
2%
5%
Since the reported water solubility value of EPTC is 370 ppm, 5 percent runoff is assumed
for all terrestrial plant exposures.
The following table summarizes the expected off site exposure to terrestrial plants at various
application rates.
Table 28. Estimates of exposure to non-target plants offsite. EECs are in Ib ai/acre so they can be
compared with the results of terrestrial plant toxicity tests, which are either an EC2S or an ECOS in Ib
ai/acre.
EECs for Terrestrial Plants in Ib ai/acre
Use Pattern
(G=granular
S=Spray)
4.5 Ib ai/acre (G) beans
Depth of soil Incorp.
(cm)
5
Drift (0.01 [1%]; S)
(0%; G),
none
Upland (dry) soils from
sheet runoff (0.05 [5%])
+ Drift
0.045
Wetland soils from
channelized runoff
(0.05 [5%]) + Drift
0.45
Upland EEC= (4.5 Ib/a X 0.05 X 1 acre) / 5 (depth inc.) + no drift = 0.045 Ib/a
Wetland EEC=(4.5 Ib/aX 0.05 X 10 acres) / 5 (depth inc.) + no drift = 0.45 Ib/a
3 Ib ai/acre (G) com*
4 Ib ai/acre (G) alfalfa*
3.7
5
none
0.04
0.4
Upland EEC= (3 Ib/aX 0.05 X 1 acre) / 3.7 (depth inc.) + no drift = 0.04 Ib/a
Wetland EEC=(3 Ib/a X 0.05 X 10 acres) / 3.7 (depth inc.) + no drift = 0.4 Ib/a
* Applications to corn are incorporated to a depth of 3.7 cm, while applications to alfalfa are incorporated to a depth of 5 cm. Therefore, the amount
available for runoff, and subsequent exposure to plants from runoff, is approximately the same, even though the application rates in Ibs ai/acre are different.
3.1 Ib ai/acre (S) beans, 1 5
alfalfa |
0.031
(3.1X0.01)
0.062
0.34
Upland EEC= (3.1 Ib/a X 0.05 X 1 acre) / 5 (depth inc.) + 0.031 Ib/a (drift) = 0.062 Ib/a
Wetland EEC=(3. 1 Ib/a X 0.05 X 10 acres) / 5 (depth inc.) + 0.03 1 Ib/a (drift) = 0.34 Ib/a
6 Ib ai/acre (G) potatoes
5
none
0.06
0.6
Upland EEC= (6 Ib/a X 0.05 X 1 acre) / 5 (depth inc.) + no drift = 0.06 Ib/a
Wetland EEC=(6 Ib/a X 0.05 X 10 acres) / 5 (depth inc.) + no drift = 0.6 Ib/a
6. 1 Ib ai/acre (S) corn,
potatoes
7.5
0.01
0.10
0.47
Upland EEC= (6.1 Ib/a X 0.05 X 1 acre) / 7.5 (depth inc.) + 0.061 Ib/a (drift) = 0.09 Ib/a
Wetland EEC=(6.1 Ib/a X 0.05 X 10 acres) / 7.5 (depth inc.) + 0.061 Ib/a (drift) = 0.36 Ib/a
With multiple applications, for crops such as potatoes and alfalfa, the exposure to plants from
the second treatment may be higher than from a single application. However, the amount of increase
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cannot be estimated with any degree of certainty with current models and the difference will not
change the risk conclusions significantly.
Risk to Terrestrial Plants
The following table shows the risk quotients for various use patterns.
Table 29. Showing risk quotients for non-target terrestrial plants in areas adjacent to EPTC
treated sites
Use pattern
(G=granular S=Spray)
4.5 Ib ai/acre (G) beans*
3 Ib ai/acre (G) corn*
4 Ib ai/acre (G) alfalfa*
3.1 Ib ai/acre (S) beans, alfalfa*
6 Ib ai/acre (G) potatoes*
6.1 Ib ai/acre (S) corn, potatoes *
RQs for Terrestrial Plants
Drift exposure EECs compared
to vegetative vigor test results*
EEC/EC25 0.22
Ib ai/a MRID
43217101
none
none
0.14
none
0.28
EEC/EC05 0.023
Ib ai/a MRID
42120802
ending, sp.
none
none
1.3
none
2.7
Upland (dry) soils EEC
compared to seedling emergence
test results*
EEC/EC250.10
Ib ai/a
MRID
42120802
0.45
0.4
0.62
0.6
1.0
EEC/EC05 0.017
Ib ai/a MRID
42120802
ending, sp.
2.6
2.4
3.4
3.5
5.9
Wetland soils EEC compared to
seedling emergence
test results*
EEC/EC250.10
Ib ai/a
MRID
42120802
4.5
4.0
3.6
6.0
4.7
EEC/EC05
0.017 ai/a
MRID
42120802
ending, sp.
26
24
20
35
28
* Exposure from the various routes (drift and/or runoff) are compared to the terrestrial plant EC25 to determine risk to terrestrial plants in general
(nonendangered), and to the EC05 to determine possible effects to endangered plants.
This table shows that most uses of EPTC are a risk to terrestrial plants, except for some drift
exposure, which shows applications up to approximately 6 Ibs ai/acre. Some usage is at higher
application rates (ornamentals). The risk quotients could be higher; possibly over twice as high, for
a 15 Ibs ai/acre application rate. However, EECs were not calculated, because of the high degree of
uncertainty in calculating runoff exposure from this use. Endangered plants may also be affected.
Endangered Species
The level of concern is exceeded for endangered and terrestrial plants species such as
monocots and dicots . Non-target terrestrial plants in adjacent fields or habitats are potentially at risk
from spray drift from some uses and from runoff for all registered uses. EPTC also appears to have
the potential to be transported off site via the vapor phase as it was one of a number of residues found
in more than 25 percent of the rain samples collected in three water sheds in Minnesota. In addition,
being a herbicide, EPTC may also have an indirect effect on endangered insects by adversely affecting
the plants on which they depend.
As member of the Endangered Species Task Force, the registrant will be required to obtain
information which identifies endangered and threatened species of concern which may be found in
areas adjacent to crops treated with EPTC.
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b. Environmental Risk Characterization
EPIC is volatile and must be soil incorporated to a depth of 1.5 to 4 inches within a relatively
short time (within 2 to 36 hours following application) in order to be efficacious for control of weed
germination. The method of EPIC application and soil incorporation appears to have more effect
on the potential for risks expressed as risk quotients than either the use site or the use rate. Based
on the available toxicity data, all EPIC uses, except for chemigation, yield risk quotients which
exceed the levels of concern for high acute (LOG = 0.5) and sublethal risks (LOG = 1) to small
herbivorous and/or insectivorous mammals and for non-target terrestrial plant species (LOG = 1).
None of the application methods or uses appear to pose acute risks to birds, beneficial
insects, or freshwater organisms. Risks could not be assessed for acute effects on estuarine fish,
oysters, and shrimp, or for reproductive effects on birds, freshwater fish and invertebrates, and
estuarine fish and invertebrates, because toxicity studies have not been submitted to support
applications on major crops grown in coastal counties or to support multiple applications. No
information is available on the toxicity of EPTC degradates or metabolites. The half-life of one
degradate, EPTC sulfoxide, appears to be shorter than the half-life for EPTC.
Field conditions and crop growth stage for EPTC applications are dependent on the use site.
EPTC may be used at practically all stages of crop growth, including applications at pre-plant,
at-plant, pre-emergence, post-emergence, foliar application, lay-by, and a fall application. In all cases,
soil incorporation is necessary for efficacy to reduce volatilization of EPTC. The depth of soil
incorporation ranges from 1.5 to 4 inches. Since EPTC is more volatile on wet soils, the labels
recommend that soils should be dry to a depth of about 0.5 inches prior to application. Fields need
to be "cleaned" to uproot any germinated weeds prior to any EPTC application. Vegetation in the
fields at treatment may include crop residues and uprooted weeds.
Mechanical incorporation into the soil disrupts the soil surface and exposes insects and soil
organisms and leaves some vegetation on the soil surface. The amount of vegetation in the field
during spray applications may vary from abundant to sparse in "clean fields." Freshly plowed fields
attract many bird species to feed on insects and soil organisms. Mammals, such as opossums, skunks,
raccoons, field mice and foxes, may be attracted to feed in plowed fields at dusk and during the night.
The endpoint for the mammalian chronic effects based on adverse effects, and were identified
in a two-generation rat reproduction study at 200, and 800 ppm EPTC. The overall NOAEL value
for the study was 50 ppm, based on maternal effects (including decreased body weight and
degenerative cardiomyopathy) at 200 ppm.. No reproductive effects were identified at 800 ppm, the
highest test concentration. At 800 ppm, the pups had reduced body weight.
Degenerative cardiomyopathy is an abnormality in the function of the heart muscle, which
seriously reduces physical abilities of the effected animal. The Agency considers maternal effects,
such as cardiomyopathy, to be a subchronic effect. Cardiomyopathy is a cumulative effect increasing
from one exposure to next (i.e., multiple exposures are additive in their effect on the heart muscle).
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Reduced body weight and degenerative cardiomyopathy are ecologically significant because they
expected to adversely effect biological competition for food, reproductive dominance, and predator
avoidance.
In two cases, sufficient information was available on chemigation uses to assess any risk to
non-target organisms, based on EPIC concentrations in the water applied to a crop. EPIC use on
corn in the semi-arid areas of the Pacific Northwest is 6.1 Ibs a.i./A, in 0.5 to 0.75 inches of water.
Based on an application of 0.5 inch, the EPIC concentration is about 54 ppb in the chemigation
water. In a standing alfalfa field study in California's Imperial Valley (Claith etal. 1980), EPTC was
applied at a rate of 3.04 kg/ha (i.e., 2.7 Ibs ai/A) at an average concentration of 2.17 ppm in the head
ditch water, and the irrigation water flowed across the field and collected on the far side of the field.
During the 52 hour monitoring period, 28.4 percent of the total EPTC applied volatilized from water, 45.2
percent volatilized from wet soil, and 7 percent ran off the far side of the field as 1.92,1.97, 1.76 and 1.44 ppm
EPTC.
The EPTC concentrations in water bodies from chemigation for use on these two crops pose
no risk to any fish or wildlife group. In the case of alfalfa, there was no risk to non-target terrestrial
plants, because the runoff was collected in ditches at the far side of the field. Risks to non-target
terrestrial plants from the corn in the Pacific Northwest use were estimated based on spray drift and
runoff following a rain event. Risks from spray drift alone exceeded only the endangered and
threatened plant species LOG. Risks from rainfall runoff were assumed to be similar to broadcast
applications or slightly higher, if the higher soil moisture content increased the amounts of water in
the runoff.
Risk quotients from granular applications exceed the levels of concern for high acute toxicity
for small herbivorous and/or insectivorous mammals, and for high risks to non-target terrestrial
plants. Since the EPTC granules are very fine clay particles, it is unlikely that small mammals would
consume a sufficient number of granules to be affected. Granular applications of these small particles
are assumed not to be blown into adjacent habitats as is the case for spray drift. Thus, the risks from
granular formulations would appear to be limited to runoff into habitats of non-target terrestrial
plants, with concern levels slightly less than spray application, because there is no spray drift from
granular applications.
Risk quotients from broadcast spray applications exceed the Agency's levels of concern for
high acute and sublethal effects for small herbivorous and/or insectivorous mammals, and for high
risks to non-target terrestrial plants. If irrigation is used to incorporate EPTC into the soil, risks to
small mammals would be limited to the time period between application and some time after irrigation
began when the residues of wildlife food items are diluted and/or leach into the soil. Irrigation may
possibly increase the risks to non-target plants if higher soil moisture content increases runoff from
rain events. If the spray application is soil incorporated using mechanical means, EPTC concentration
levels will continue to exist on the exposed vegetation on the soil surface until the EPTC residues
volatilize or are washed into the soil by rain.
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On a per pound active ingredient per acre basis, broadcast spray applications appear to pose
the highest risks to small mammals and non-target terrestrial plants. EPIC spray applications are
likely limited to killing a few small mammals and are not expected to produced adverse effects on
mammalian reproduction or to significantly effect populations of small mammals. Except for alfalfa,
vegetation is sparse in most treated fields compared to the more lush vegetative strips adjacent to
treated fields. Also, the duration of exposure to potentially lethal residues are limited due to the high
volatility of EPTC on exposed food items and to the predilection of EPTC residues to wash off and
leach into the soil with rain. The duration of potential risks to small mammals is uncertain, because
persistence of EPTC on food items is mostly a function of local climatic conditions, such as
temperature, winds, soil moisture, and rainfall. Fate studies indicate that field dissipation half-lives
range from about 2 to 19 days.
Non-target terrestrial plants in adjacent fields or habitats are potentially at risk from spray drift
from some uses and from runoff for all registered uses. Chemigation and soil incorporation by
wetting increase soil moisture levels which may increase runoff levels. Non-target terrestrial plants
are at risk from spray drift at application rates of > 2.6 Ibs ai/A, runoff into wet habitats at all
registered use rates; and runoff into dry habitats at use rates > 2 Ibs ai/A. The level of concern for
endangered terrestrial plant species is exceeded for both monocots and dicots and the concerns need
to be addressed by the registrant.
The Agency has identified the following endangered and threatened species groupings as
potentially at risk from EPTC uses: small mammalian herbivores, small mammalian insectivores and
terrestrial plants. In consultations with the U.S. Fish and Wildlife Service in 1983-84 for the Forestry
"cluster" and again in 1989 in a re-initiation on "clusters", jeopardy to some plants were identified
in both consultations for EPTC. As member of the Endangered Species Task Force, Zeneca, is
involved in obtaining information which identifies endangered and threatened species of concern
which may be found in areas adjacent to crops treated with EPTC.
Volatility as a major route of field dissipation raises concerns about the atmospheric fate of
EPTC, its aerial transport and whether aerial deposition poses the potential for risks to small
mammals and non-target terrestrial plants. The fate of EPTC in the atmosphere and the potential for
atmospheric offsite deposition is uncertain. Based on toxicity data, aerial deposition would not
appear to be a risk to animals or aquatic habitats. But risks to non-target terrestrial plants are a
concern based of the sensitivity of a number of terrestrial plant species to seedling emergent effects
on wild oats (EC 0.10 Ibs ai/A), vegetative effects (EC ) at 0.22 Ibs ai/A, significant reduction in
dry weight (EC2j) at 0.23 Ibs ai/A for winter wheat, and ECQ5 values as low as 0.017 Ibs ai/A for wild
oats.
Whether these levels of EPTC are likely to be atmospherically deposited into soils or on
vegetation is uncertain. The absence of reported atmospheric deposition incidences does not preclude
the occurrence of such events. Zeneca reported one 6(a)2 incident in Pennsylvania in which there was
a reduction in the stand and stunted plants in alfalfa and stunted and killed tomato plants. No
additional details were provided, but EPTC was identified as the possible cause of the symptoms.
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant
data concerning an active ingredient, whether products containing the active ingredient are eligible
for reregi strati on. The Agency has previously identified and required the submission of the generic
(i.e. active ingredient specific) data required to support reregi strati on of products containing EPTC
as an active ingredient. The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregi strati on of all products containing EPTC.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregi strati on eligibility of EPTC.
These data were sufficient to allow the Agency to determine that EPTC can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing EPTC as the active ingredients are eligible for reregistration. Actions
needed to reregister particular products are addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the data required for
reregistration, current guidelines for conducting acceptable studies to generate such data and
published scientific literature. Although the Agency has found that all uses of EPTC are eligible for
reregistration, it should be understood that the Agency may take appropriate regulatory action, and/or
require the submission of additional data to support the registration of products containing EPTC,
if new information comes to the Agency's attention or if data requirements for registration (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on reviews of the generic data for the active ingredient EPTC, the Agency has sufficient
information on the health effects of EPTC and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency has determined that EPTC products, labeled and used as
specified in this Reregistration Eligibility Decision, will not pose unreasonable risks of adverse effects
to humans or the environment. Therefore, the Agency concludes that products containing EPTC for
all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of EPTC are eligible for reregistration under the
conditions specified in this RED.
B. Regulatory Position
The following is a summary of the Agency's regulatory position and rationale for managing
risks associated with the use of EPTC. Where labeling revisions are imposed, specific language is
set forth in Section V of this document.
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In order to be eligible for registration the registrant the following changes are required:
Risk to occupational handlers
The exposure assessments indicate that occupational handlers are at risk to dermal
and inhalation exposure, and that additional protective measures are necessary to
reduce these risks. Therefore, various forms of additional personal protective
equipment (PPE) (e.g., double layer clothing and respirators) and engineering controls
(e.g., enclosed cockpits) are necessary for certain handler scenarios to reduce the risks
to below the Agency's level of concern.
In order to mitigate risks to homeowners, the registrant will be required to add label
language which prohibit the use of the belly grinder, which contributes to the highest
level of exposure, for home owner products. The registrant will also be required to
delete all residential emulsifiable concentrate formulation uses from the EPTAM 7E
label. In addition the registrant will be required to change the maximum rate of 15
Ibs per acre for the Eptam 2.3 granular products to the typical rate of 5 Ibs per acre
for residential products.
Risk quotients for granular and spray applications suggest that EPTC poses adverse
effects to small herbivorous and insectivorous mammals for most uses and adverse
effects on non-target terrestrial plants for all uses. EPTC use could also cause
adverse effect on endangered species. As member of the Endangered Species Task
Force, the registrant will be required to obtain information which identifies
endangered and threatened species of concern which may be found in areas adjacent
to crops treated with EPTC.
The registrant will also be required to provide additional data as following:
Guideline: Study:
870.6300 Developmental neurotoxicity study in the rat
860.1340 Residue Analytical methods-Plant
860.1360 Multiresidue Method
860.1380 Storage Stability Data
860.1520 Processed Food/ Feed
860.1500 Crop field Trials
Guideline: Study:
850.2100 Acute Avian Oral (quail/duck)
850.2300 Avian Reproduction (quail/duck)
850.1010 Invertebrate toxicity
850.1025 Estu/mari tox mollusk
850.1035 Estu/mari tox shrimp
850.1045 Estu/mari tox fish
850.1300 Life cycle invertebrate
835.4300 Aerobic Aquatic Metabolism
835.8100 Field Volatility
835.1240 Leach/adsorption/deportation
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1. Food Quality Protection Act Findings
With EPIC, there was an increased incidence and severity of neuronal necrosis/degeneration
in both the central and peripheral nervous systems of both rats and dogs. Because of the neurotoxic
effects (neuronal necrosis/degeneration) and the potential for residential exposure to infants and
children from use of EPTC, the Agency's FQPA Safety Factor Committee recommended that the
lOx FQPA safety factor be retained for all populations which includes infants and children. The
uncertainty regarding the effects on the developing fetal nervous system after such exposure is being
addressed by the requirement of a developmental neurotoxicity study in rats.
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for EPTC, with the amendments and
changes specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty of no harm for the general
population. In reaching this determination, EPA has considered available information on the
aggregate exposures (both acute and chronic) from non-occupational sources, and food and drinking
water, as well as the possibility of cumulative effects from EPTC and other compounds that may have
a similar mechanism of toxicity.
In assessing aggregate risk, the agency considered potential dietary exposure of the general
population to EPTC residues from food and drinking water, and potential dermal and inhalation
exposure from use in residential settings. The aggregate assessment for the general population and
specific subgroups addressed food, water, and residential exposures. Short-term aggregate risk
estimates do not exceed the Agency's's level of concern.
Acute and chronic risk from food do not exceed the Agency's level of concern. Acute and
chronic dietary (food) exposure analyses were conducted using the Dietary Exposure Evaluation
Model (DEEM). In both assessments, exposure (consumption) was compared to a population
adjusted dose (PAD) reflecting retention of the FQPA lOx factor. The PAD is equal to the acute or
chronic RfD divided by the FQPA Safety Factor. The Agency considers dietary residue contributions
greater than 100% of the PAD of concern. Acute dietary exposure at the 95th percentile comprised
40.5% of the aPAD for the general population and 87.5% of the aPAD for the most highly exposed
subgroup, children (1-6 years). Chronic dietary exposure comprised 9.6% of the cPAD for the
general population and 17.4% of the cPAD for the most highly exposed subgroup, children (1-6
years). The acute analysis at the 95th percentile is a conservative, deterministic upper-bound estimate
which utilized tolerance-level input residues and assumed 100% crop treated. The chronic analysis
(Tier 3) is a refined estimate which used average field trial residues and percent of crop treated data.
Chronic (non-cancer) aggregate risk estimates do not exceed the Agency's level of concern.
The aggregate chronic dietary risk estimates include exposure to EPTC residues in food and water.
No chronic residential use scenarios were identified. Exposure (food only) to combined residues of
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EPTC and its metabolites of toxicological concern, based on a Tier 3 refinement, using average
residues from field trial and percent of crop treated data, represents 17.4% of the chronic PAD for
the most highly exposed population subgroup (children 1-6 years). Exposure to all other groups
represents less than 14.8% of the chronic PAD. Using conservative screening-level models, the
estimated maximum l-in-10 year annual average of EPTC in surface water is 3.44 //g/L. This
estimated average concentration is less than the drinking water level of comparison for exposure to
EPTC in drinking water as a contribution to aggregate chronic dietary risk. Based on available
information, the Agency concludes with reasonable certainty that no harm to any population will
result from chronic dietary exposure to EPTC.
b. Determination of Safety for Infants and Children
EPA has determined that established tolerances for EPTC, 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, and that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers factors noted above for the
general population, but also takes into account the possibility of increased dietary exposure due to
specific consumption patterns of infants and children, as well as the possibility of increased
susceptibility to the toxic effects of EPTC residues in this population subgroup.
During the early stages of the FQPA implementation process, EPA recognizes that it will be
necessary to make some decisions before the implementation process is complete. In making these
early, case-by-case decisions, EPA does not intend to set broad precedents regarding the application
of FQPA to its regulatory determinations. These early decisions will not bind EPA as it proceeds
with further policy development and rulemaking that may be required.
If, as a result of this later implementation process, EPA determines that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to, reconsideration of any portion of this RED.
2. Tolerance Reassessment Summary
At this time, the Agency does not believe it has sufficient reliable information concerning
common mechanism issues to determine whether EPTC, a thiocarbamate, shares a common
mechanism of toxicity with other cholinesterase-inhibiting chemicals. Therefore, for the purposes of
this tolerance reassessment, the Agency has assumed that EPTC does not share a common mechanism
of toxicity with cholinesterase-inhibiting chemicals.
Established tolerances for residues of EPTC in/on plant commodities are currently expressed
in terms of residues of EPTC per se [40 CFR §180.117]. Based on results of acceptable plant
metabolism studies, the Agency's Metabolism Committee has determined that the tolerance expression
for EPTC should be revised to regulate residues of EPTC, EPTC sulfoxide, EPTC sulfone, and
glutathione conjugate of the sulfone metabolite, and all subsequent conjugates thereof.
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The hydroxylated metabolites of EPTC (i.e., N-2-hydroxy propyl EPTC, N-3-hydroxy propyl
EPIC, and 2-hydroxymethyl EPTC) were determined not to be of toxicological concern because of
the low levels (10% of TRR) at which they are formed in plants. However, to facilitate development
by the registrant of an analytical method for enforcement purposes, the Metabolism Committee
concluded that the hydroxylated metabolites could be used as marker compounds of EPTC
metabolites mentioned in the preceding paragraph. The tolerance expression, therefore, will now
consist of residues of EPTC per se and the EPTC hydroxylated metabolites mentioned above. Hence,
all EPTC tolerances have been reassessed, based on residue data for the combined residues of EPTC
and its hydroxylated metabolites.
The Agency considers residues of EPTC in animal commodities to be a Category 3 situation
under 40 CFR §180.6(a), in which it is not possible to establish with certainty whether finite residues
will be incurred, but there is no reasonable expectation of finite residues in animal commodities. No
tolerances on animal commodities are warranted.
The Agency has recently updated the list of raw agricultural and processed commodities and
feedstuffs derived from crops. As a result of this update, EPTC tolerances for certain raw agricultural
commodities which have been removed from the livestock feeds table need to be revoked. Also,
some commodity definitions must be corrected.
Tolerances were reassessed based on residue data depicting combined residues of EPTC and
its three hydroxylated metabolites (i.e., N-(2-hydroxy)propyl; N-(3-hydroxy)propyl; S-(2-
hydroxy)ethyl metabolites). In the tolerance reassessment, a level of quantification (LOQ) of 0.05
ppm was chosen for EPTC because the LOQ is < 0.05 ppm (see section entitled GLN 860.1500:
Crop Field Trials), and the level of detection (LOD) of the enforcement analytical method is 0.02-
0.04 ppm. For each of the three hydroxylated metabolites, the LOQ of the 0.01 ppm of the proposed
enforcement method (see section entitled GLN 860.1340: Residue Analytical Methods) was used.
Hence, the minimal tolerance is 0.08 (0.05 for EPTC, plus 0.03 for the combined hydroxylated
metabolites) since this represents the minimal quantifiable amount. A summary of EPTC tolerance
reassessments is presented in Table 27. Pending independent laboratory validation of the enforcement
analytical method for the hydroxylated metabolites, the reassessed tolerances represent revised EPTC
tolerances.
Tolerances Listed Under 40 CFR §180.117
Pending submission of supporting storage stability data, sufficient field trial data have been
submitted to reassess the established tolerances for the following commodities: almond, hulls,
cottonseed, safflower seed, and sunflower seed.
Sufficient field trial data are not available to adequately reassess the established tolerances for
the following commodities: flaxseed, fruits, citrus, and strawberries.
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The majority of the established group tolerances for residues of EPTC per se are based on
obsolete crop groupings and, for many, the minimum requirements for the establishment of crop
group tolerances have not been satisfied. Therefore, the Agency is recommending the revocation of
the group tolerances listed below, concomitant with the establishment of individual tolerances for the
affected commodities. The recommendations listed below should be considered tentative in the
absence of complete supporting storage stability data for EPTC residues for which storage stability
data remain outstanding, including the hydroxylated metabolites that will be used as marker
compounds.
Sufficient data have been submitted for sugar beet roots and potatoes, which are
presently covered by the tolerance established for "vegetables, root crop." Available
data for sugar beet roots can be translated to garden beet roots, and available data for
potatoes can be translated to sweet potato. The tolerance for this obsolete group
should be deleted and individual tolerances should be established for: beet, garden,
roots, beet, sugar, roots, potato, and sweet potato.
• Sufficient data have been submitted for sugar beet tops, which are presently covered
by the tolerance established for "vegetables, leafy." Available data for sugar beet tops
can be translated to garden beet tops. The tolerance for this obsolete group should
be deleted and individual tolerances should be proposed for: beet, garden, tops
(leaves), and beet, sugar, tops (leaves).
• Sufficient data have been submitted for beans (succulent and dry) which are presently
covered by the tolerance established for "vegetables, seed and pod." The available
data for succulent beans can be translated to succulent peas. The tolerance for this
obsolete group should be deleted and individual tolerances should be established for:
bean, seed (dry), bean, succulent, and pea, succulent.
• Sufficient data have been submitted for tomatoes which are presently covered by the
tolerance established for "vegetables, fruiting." The tolerance for this group should
be deleted and an individual tolerance should be established for tomato.
• Sufficient data have been submitted for almonds and walnuts which are presently
covered by the tolerance established for "nuts." The tolerance for this obsolete group
should be deleted and individual tolerances should be established for: almond,
nutmeat, and walnut, nutmeat.
Sufficient data have been submitted for field corn grain and sweet corn (K + CWHR),
which are presently covered by the tolerance established for "grain crops." The
tolerance for this group should be deleted and individual tolerances should be
established for: corn, field, grain, corn, pop, grain, and corn, sweet (K + CWHR).
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• Sufficient data have been submitted for field corn forage and fodder (stover) and
sweet corn forage and fodder (stover), which are presently covered by the tolerance
established for "forage grasses." The tolerance for this group should be deleted and
individual tolerances should be established for: corn, field, forage; corn, field, stover;
corn, pop, stover; corn, sweet, forage, and corn, sweet, stover.
• Sufficient data have been submitted for alfalfa forage, clover forage, and hay which
are presently covered by the tolerance established for "legumes, forage." Available
data for clover forage and hay can be translated to the forage and hay of Birdsfoot
trefoil and lespedeza. The tolerance for this obsolete group should be deleted and
individual tolerances should be established for: alfalfa, forage, alfalfa, hay, Birdsfoot
trefoil, forage, Birdsfoot trefoil, hay; clover, forage; clover, hay, lespedeza, forage,
and lespedeza, hay. (Because product labels prohibit use of EPTC on cowpeas and
restrict use on peas to succulent peas, no tolerances for cowpea forage and hay or
field pea vines and hay are required.)
The established tolerance for castor beans should be revoked since the registered use of EPTC
on castor beans is more appropriately classified as a non-food use. Castor beans and oil products are
not consumed by humans or livestock; thus, a tolerance for EPTC residues of concern in/on castor
beans is not necessary.
The established tolerance for cotton, forage should be revoked since cotton forage is no
longer considered a significant livestock feed item.
The established tolerances for asparagus, small fruits, and pineapples should be revoked since
there are no registered uses of EPTC on these crops.
Tolerances to be Proposed Under 40 CFR §180.117
A tolerance for EPTC residues of concern in/on cotton gin byproducts must be established
once adequate field residue data, reflecting the maximum registered use pattern, have been submitted
and evaluated.
The available processing data for potatoes indicate that residues of EPTC and its hydroxylated
metabolites concentrate minimally (1.4-fold) in granules processed from treated potatoes. This low
degree of concentration of EPTC residues in granules does not warrant a tolerance for this processed
commodity.
The available processing data for sugar beets indicate that residues of EPTC and its
hydroxylated metabolites concentrate appreciably (4-fold) in molasses processed from treated sugar
beets. Therefore, a tolerance of 0.4 ppm for the combined residues of EPTC and its hydroxylated
metabolites in molasses must be established.
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Table 30. Tolerance Reassessment Summary for EPTC.
Commodity
Current
Tolerance, ppm 1
Reassessed
Tolerance, ppm 2
Comment
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.117
Almonds, hulls
Asparagus
Beans, castor
Cotton, forage
Cottonseed
Flaxseed
Fruits, citrus
Fruits, small
Grain crops
Grasses, forage
Legumes,
forage
Nuts
Pineapples
Safflower, seed
Strawberries
Sunflower,
seed
Vegetables,
fruiting
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
O.l(N)
0.08
Revoke
Revoke
Revoke
0.08
TBD3
TBD3
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
0.08
TBD3
0.08
Revoke
[Almond, hulls] Pending submission of supporting storage
stability data, sufficient field trial data have been submitted to
reassess the established tolerance.
There are currently no registered uses of EPTC on asparagus.
EPTC use on castor beans is classified as a non-food use.
This item is no longer considered a significant livestock feed
item (Table 1, OPPTS 860.1000).
[Cotton, undelinted seed] Pending submission of supporting
storage stability data, sufficient field trial data have been
submitted to reassess the established tolerance.
[Flax, seed] Sufficient field trial data are not available to
adequately reassess the established tolerance.
[Citrus fruits (Citrus spp., Fortunella spp.) group] Sufficient
field trial data are not available to adequately reassess the
established tolerance.
There are currently no registered uses of EPTC on small fruits.
The established tolerance should be revoked and individual
tolerances should be proposed for: com, field, grain; corn, pop,
grain; and corn, sweet (K + CWHR).
The established tolerance should be revoked and individual
tolerances should be proposed for: corn, field, forage; corn,
field, stover; com, pop, stover; com, sweet, forage; and corn,
sweet, stover.
The established tolerance should be revoked and individual
tolerances should be proposed for: alfalfa, forage; alfalfa, hay;
Birdsfoot trefoil, forage; Birdsfoot trefoil, hay; clover, forage;
clover, hay; lespedeza, forage; and lespedeza, hay.
The established tolerance should be revoked and individual
tolerances should be proposed for: almond, nutmeat; and
walnut, nutmeat.
There are currently no registered uses of EPTC on pineapple.
Pending submission of supporting storage stability data,
sufficient field trial data have been submitted to reassess the
established tolerance.
[Strawberry] Sufficient field trial data are not available to
adequately reassess the established tolerance.
Pending submission of supporting storage stability data,
sufficient field trial data have been submitted to reassess the
established tolerance.
The established tolerance should be revoked and an individual
tolerance should be proposed for tomato.
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Tolerances Listed Under 40 CFR §180.117
Commodity
Vegetables, leafy
Vegetables, root
crop
Vegetables, seed
and pod
Current
Tolerance, ppm '
O.l(N)
O.l(N)
O.l(N)
Reassessed
Tolerance, ppm 2
Revoke
Revoke
Revoke
Comment
[Correct Commodity Definition
The established tolerance should be revoked and individual
tolerances should be proposed for: beet, garden, tops (leaves);
and beet, sugar, tops (leaves).
The established tolerance should be revoked and individual
tolerances should be proposed for: beet, garden, roots; beet,
sugar, roots; potato; and sweet potato.
The established tolerance should be revoked and individual
tolerances should be proposed for: bean, seed (dry); bean,
succulent; and pea, succulent.
Tolerance To Be Established Under 40 CFR §117 (a)
Alfalfa, forage
Alfalfa, hay
Almond, nutmeat
Bean, seed (dry )
Bean, succulent
Beet, garden,
roots
Beet, garden, tops
(leaves)
Beet, sugar,
molasses
Beet, sugar, roots
Beet, sugar, tops
(leaves)
Birdsfoot trefoil,
forage
Birdsfoot, hay
Clover, forage
Clover, hay
Corn, field,
forage
Corn, field, grain
Corn, field,
stover
Corn, pop, grain
Corn, pop, stover
Corn, sweet (K +
CWHR)
Corn, sweet,
forage
Corn, sweet,
stover
—
—
—
—
—
--
--
--
—
--
--
—
—
—
--
—
--
—
—
--
--
--
0.2
0.6
0.08
0.08
0.08
0.1
0.5
0.4
0.1
0.5
0.1
0.1
0.1
0.1
0.08
0.08
0.08
0.08
0.08
0.08
0.08
0.08
The recommended tolerances are based on translation of data
from sugar beet roots and tops.
The recommended tolerances are based on translation of data
from clover forage and hay.
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Cotton gin
byproducts
Lespedeza, forage
Lespedeza, hay
Pea, succulent
Potato
Sweet potato
Tomato
Walnut, nutmeat
--
—
—
--
—
--
—
--
TBD3
0.1
0.1
0.08
0.1
0.1
0.08
0.08
The recommended tolerances are based on translation of data
from clover forage and hay.
The recommended tolerance is based on translation of data from
succulent beans.
The recommended tolerance is based on translation of data from
potatoes.
Tolerances were reassessed based on residue data depicting combined residues of EPTC and its three hydroxy metabolites (i.e., its N-(2-
hydroxy)propyl; N-(3-hydroxy)propyl; and S-(2-hydroxy)ethyl metabolites). In the tolerance reassessment a level of quantification (LOQ) of
0.05 ppm was chosen for EPTC because the LOQ is < 0.05 ppm (see section entitled GLN 860.1500: Crop Field Trials), and the level of
detection (LOD) of the enforcement analytical method is 0.02-0.04 ppm. For each of the three hydroxylated metabolites, the LOQ of the 0.01
ppm of the proposed enforcement method (see section entitled GLN 860.1340: Residue Analytical Methods) was used. Hence, the minimal
tolerance is 0.08 (0.05 for EPTC, plus 0.03 for the combined hydroxylated metabolites) since this represents the minimal quantifiable amount.
TBD = To be determined. Reassessment of tolerance(s) cannot be made at this time because additional data are required.
3.
Codex Harmonization
There are no proposed or established Codex maximum residue limits (MRLs) for residues of
EPTC in/on various plant and animal commodities. Therefore, issues of compatibility between Codex
MRLs and U.S. tolerances do not exist.
4. Risk Mitigation
a. Risk Mitigation for Occupational Handler Exposure
Based on occupational handler exposure scenarios, handlers are at risk to exposure from
EPTC. There are both short and intermediate term endpoints, but the intermediate endpoints, which
are the endpoint the Agency is using to regulate EPTC, results in risks of concern. The exposure
assessments indicate that handlers are at risk to dermal and inhalation exposure, and that additional
protective measures are necessary to reduce their exposure risks. To address this concern, various
forms of additional personal protective equipment (PPE) (e.g., double layer clothing and respirators)
and engineering controls (e.g., enclosed cockpits) are necessary for certain handler scenarios to
reduce the risks below the Agency's level of concern (see the table below for specific handler
protection requirements).
To lessen the risks to occupational handlers posed by EPTC, in addition to baseline (long
pants, long sleeve shirt, socks, and shoes), the Agency is requiring the following mitigation for EPTC
products:
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Mixers/Loaders of the emulsifiable concentrate (EC) must wear and use chemical
resistant (CR) gloves, CR apron, and CR footwear. In addition, to support
chemigation M/L must wear an organic vapor (OV) respirator.
Mixing/Loading EC for Impregnation on Dry Bulk Fertilize must wear CR gloves, CR
apron, must also use Closed System.
Loaders of granules for aerial equipment must wear an OV respirator.
Applicators of dry bulk fertilizer using a specialized truck* must wear an OV resp.
Mixers/Loaders/Applicators of the EC using hand-held equipment must wear CR
gloves.
Aerial applicators must be in an enclosed cockpit.
Loaders/Applicators of the granular using hand-held equipment must wear CR gloves.
Loader/Applicators using the Belly Grinder (hand-held broadcast spreader, must
wear double layers, CR footwear.
Occupational Handler Dermal and Inhalation Mitigation
Handler dermal exposure to EPTC is below the Agency's level of concern for some exposure
scenarios. The target MOE= 100 is achieved for exposure scenarios la, Ib, ld,5,8,10,andll, when
additional PPE such as chemical resistant gloves, footwear, apron and respirator were applied.
Where baseline PPE did not result in acceptable MOE, the Agency assessed risk using double layers
of body protection. However, since maximum PPE resulted in MOE above 1000s for some scenarios
the Agency reassessed these scenarios using CR gloves in addition to baseline PPE for all applicators
except the belly grinder. As a result, MOEs were acceptable with gloves only. The belly grinder did
not achieve an MOE greater then 100 with baseline PPE and gloves until a double layers were added.
Although there is no data to specifically assess the exposure reduction to mixers/loaders
afforded by a chemical-resistant apron (CRA), the Agency is substituting the double layer body
protection for the CRA and believes that the resulting reduction is significant. Available data
indicate that the preponderance of non-hand exposure to mixers/loaders is to the front torso.
Therefore, for mixers/loaders the use of a chemical-resistant apron is probably approximately
equivalent to double-layer body protection.
Handler inhalation exposure to EPTC for all scenarios except three were below the Agency's
level of concern. Handler inhalation mitigation is achieved for these three scenarios when an organic
vapor respirator is applied. Due to lack of data at baseline additional PPE levels, closed cockpits, will
be required for aerial applicators.
For dry bulk fertilizer applications using a specialized truck, despite the fact that the
intermediate dermal and short-term and inhalation MOE's are still unacceptable even with
engineering controls, the Agency has determined that this use pattern will remain. It would be
relatively unusual for the handler to mix the highest amount (800,000 Ibs fertilizer/day) at the
maximum rate everyday. Also, the estimates are based on surrogate data which the Agency believes
overestimates the risk.
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Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators, etc).
Personal protective equipment requirements usually are set by specifying one or more pre-
established PPE units - sets of items that are almost always required together. For example, if
chemical-resistant gloves are required, then long-sleeve shirts, long pants, socks, and shoes are
assumed and are also included in the required minimum attire. If the requirement is for two layers
of body protection (coveralls over a long- or short-sleeve shirt and long or short pants), the minimum
must also include (for all handlers) chemical-resistant footwear and chemical-resistant headgear for
overhead exposures and (for mixers, loaders, and persons cleaning equipment) chemical-resistant
aprons.
For each end-use product, PPE requirements for pesticide handlers will be based on the acute
toxicity of the end-use product. For occupational-use products, PPE is established using the process
described in PR Notice 93-7 or more recent EPA guidelines determined by comparing the PPE
requirements based on the toxicity of the active ingredient, as listed earlier, with the PPE required
based on the acute toxicity of the end-use product. The more stringent choice for each type of PPE
(i.e., bodywear, hand protection, footwear, eyewear, etc.) would apply to the end-use product. As
discussed in the risk mitigation section above, the additional PPE is needed due to EPTC's high acute
toxicity or other adverse effects, such as increased incidence and severity of neuronal
necrosis/degeneration in both the central and peripheral nervous systems of both rats and dogs, the
potential for residential exposure to infants and children.
The following table provides a detail summary of handler protective equipment that will be
required on various labels.
Table 31. Summary of Handler Personal Protective Equipment.
Exposure Scenario
Mixing/Loading Emulsifiable Concentrate for
Chemigation (la)
Mixing/Loading Emulsifiable Concentrate for
Ground Application (Ib)
Mixing/Loading Emulsifiable Concentrate for
Impregnation on Dry Bulk Fertilizer (Ic)
Mixing/Loading Emulsifiable Concentrate or
Handgun (Hydraulic Sprayer)
Application(ld)
Loading Granular with Aerial Equipment
(2b)
Applying Dry Bulk Fertilizer with
Specialized Truck (4b)
Applying Spray to the Soil with Handgun
Application (5)
Applying granulars with Aerial Equipment (7
Additional PP Required
Single layer clothing, Chemical resistant (CR)
apron, CR footwear, CR gloves, Organic
Vapor respirator (OV).
Single layer clothing CR footwear , CR
gloves, CR apron.
Single layer clothing,, CR gloves, CR apron.
Single layer clothing, CR footwear, CR
gloves, CR apron.
Single layer clothing, OV respirator
Single layer clothing, OV respirator
Single layer clothing, CR gloves
Single layer clothing
Engineering Controls
None
None
Closed System
None
None
None
None
Enclosed Airplane Cockpit
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Exposure Scenario
Mixing/Loading/Applying Emulsifiable
Concentrate to the Soil with a Low Pressure
Hand Wand (8)
Mixing/Loading/Applying Emulsifiable
Concentrate to the Soil a with Backpack
Sprayer (9)
Loading/ Applying Granular with a Push- Type
Spreader (10)
Loading/ Applying Granular with a Belly
grinder Spreader (11)
Additional PP Required
Single layer clothing, CR gloves
Single layer clothing,, CR gloves
Single layer clothing,, CR gloves
Double layer clothing, CR footwear, CR
gloves
Engineering Controls
None
None
None
None
Risk from Occupational Post-Application Exposures
The current restricted entry interval (REI) for EPTC is 12 hours, with the exception that if
the product is soil-injected or soil-incorporated, the Worker Protection Standard, under certain
circumstances, allows workers to enter the treated area if there will be no contact with anything that
has been treated.
EPTC is applied is a soil-directed herbicide that must be thoroughly incorporated immediately
following application through mechanical means or watering-in. It is applied as a pre-plant application
and as a post-emergent application to established plants. Post-emergent applications include crops
such as tomatoes and beans, where hand labor activities involving contact with the soil subsurface
such as staking are common. For post-emergent applications to ornamentals in nurseries, there are
no restrictions on the timing of transplanting/harvesting the ornamentals following application. For
all crops, labeling instructions direct users to use shallow cultivation (i.e., mechanical or hand
raking/hoeing) after application to control weeds that escape control.
No product-specific postapplication exposure data were available for EPTC, therefore a
surrogate range-finder postapplication assessment was conducted. The surrogate assessment
assumed that 20 percent of the EPTC applied was available for transfer (i.e., dislodgeable) at 12
hours following application/incorporation. A transfer coefficient of 1000 cm^/hr would be
appropriate for tasks that would involve contact with the soil subsurface, such as hoeing, raking,
staking, thinning, irrigating, and transplanting (ornamentals). An eight hour work day and the
maximum EPTC application rate of 15 pounds active ingredient per acre was used. Using the high
end assumptions in this surrogate assessment, the margin of exposure at 12 hours after
application/incorporation was over a thousand.
Therefore, the EPA is establishing a 12-hour restricted-entry interval for all uses of EPTC.
The labeling should state that the REI does not begin until EPTC has been appropriately incorporated
as directed. The WPS exception allowing unrestricted entry to treated areas following application
and appropriate incorporation provided the soil subsurface will not be contacted should be cited on
the labeling using the standard language for soil incorporation.
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Occupational (both Worker Protection Standard and non-WPS) Labeling Rationale
During the reregi strati on process, EPA considers all relevant generic and product-specific
information to decide what protections and risk mitigation is needed for all products. Products may
contain various types of occupational uses, which may or may not be covered by the Worker
Protection Standard (WPS).
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) established certain
worker-protection requirements (personal protective equipment, restricted-entry intervals, etc.) to
be specified on the label of all products that contain uses covered by the WPS. Uses covered by the
WPS include all commercial and research uses on farms, forests, nurseries, and in greenhouses to
produce agricultural plants (including food, feed, and fiber plants, trees, turf grass, flowers, shrubs,
ornamentals, and seedlings). The WPS covers not only uses on plants, but also uses on the soil or
planting medium the plants are (or will be) grown in. The WPS labeling requirements pertaining to
personal protective equipment (PPE), restricted-entry intervals (REI), and notification are interim.
These requirements are to be reviewed and revised, as appropriate, during reregi strati on and other
Agency review processes.
Post-Application/Entry Restrictions
Under the Worker Protection Standard (WPS), interim restricted-entry intervals (REIs) for
all uses covered by the WPS are based on the acute toxicity of the active ingredient. The toxicity
categories of the active ingredient for acute dermal toxicity, eye irritation potential, and skin irritation
potential are used to determine the interim WPS REI. If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours. If none of the acute
toxicity effects are in category I, but one or more of the three is classified as category II, the interim
WPS REI is established at 24 hours. If none of the three acute toxicity effects are in category I or II,
the interim WPS REI is established at 12 hours. A 48-hour REI is increased to 72 hours when an
organophosphate pesticide is applied outdoors in arid areas. In addition, the WPS specifically retains
two types of REI's established by the Agency prior to the promulgation of the WPS: (1) product-
specific REI's established on the basis of adequate data, and (2) interim REI's that are longer than
those that would be established under the WPS.
b. Risk Mitigation for Residential Handler Exposure
Residential Handlers
Residential exposure risk from EPTC result from application by home owner and commercial
handlers when applying at residential sites. Since PPE is not a viable option for residential mitigation,
and application with a belly grinder spreader results in an MOE which exceeds the Agency's level of
concern, the registrant is required to add label language that prohibits the use of the belly grinder for
home owner application.
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The low pressure hand wand application is also above the Agency's level of concern therefore,
the registrant will be required to drop the Eptam 7E home owner garden and residential emulsifiable
concentrate formulation use from the 7E label. This product must be labeled for professional use only.
To lessen EPTC dermal and inhalation exposure risk the registrant will be required to
change the residential maximum rate of 15 Ibs per acre for the Eptam 2.3 granular to the typical rate
of 5 Ibs per acre.
Accordingly, in order to be eligible for registration of homeowner products, registrants will
be required to:
Prohibit the use of the belly grinder for home owner application.
Drop all residential emulsifiable concentrate formulation use from the 7E label. Only
granular products my be registered for use by residential consumers. Any EC
products registered for such use must be canceled by the registrant.
Change the residential maximum rate of 15 Ibs per acre for the Eptam 2.3 granular
to the typical rate of 5 Ibs per acre.
These use patterns will still be permitted at residential sites when applied by licensed
occupational handlers.
Residential Post-Application
The primary unacceptable scenario to residential post-application to EPTC is toddlers or
children potentially ingesting EPTC-treated soil. While it is the Agency's policy to routinely conduct
screening level assessments for incidental ingestion of granules from treated areas, the Agency
believes a toddler's exposure to EPTC granules may be outside the scope of concern because of small
formulation particle size. Since the particle size is relatively small and if used according to label
directions and soil incorporated, it is unlikely that EPTC granules would be accessible to a child.
Nonetheless, the Agency estimates that fewer than 50 EPTC granules, if eaten, would result in
adverse effects. Therefore, the agency is requiring that the potential for children's exposure to EPTC
granulars be further minimized by additional labeling which states, " Keep off sidewalks, driveways, patios,
or similar surfaces .
Risk from Non-Occupational Post Application Exposure
Human exposure to EPTC applied in parks, around buildings, golf course sandpit would be
minimum as long as EPTC is to soil incorporation or is watered in. Therefore, the Agency has
decided to require the standard labeling requirement of, "Do not enter or allow others to enter until
sprays have dried and incorporation is complete." No changes to the registration are needed.
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c. Ecological Risk Mitigation
Residue levels of EPTC on vegetation exceed levels of concern for high acute risks and effect
on endangered species for small mammals. Soil incorporation reduces the amount of vegetation
exposed, but the vegetation remaining at the surface poses a potential risk to small mammals. Since
soil incorporation is necessary within the 24 hours specified on the label for good weed control,
exposed vegetation on the field surface after soil incorporation will be sparse. The scarcity of the
treated vegetation and the rapid volatilization of EPTC from the exposed vegetation in the couple
days, reduces the magnitude and possibility of risks to a short time period. The scarcity of the
vegetation in the field is less inviting for hungry mammals than vegetative areas surrounding the field,
which also lowers the probability that many small mammals will feed in the field and will be affected
by EPTC. Given the low probability of EPTC dietary exposure to small mammals, any mortality is
unlikely to have any serious effect on the local populations of small mammals, with the exception of
an endangered species.
(1) Mammalian Mitigation
To assess the risk associated with mammals consuming EPTC treated areas, an LD50 of 916
mg/kg is used to assess possible acute lethal dietary risks. Therefore, the concentration that would
have to be in the diet of a mammal in order to achieve the LD50 would be 916 mg/kg within one day
of eating. Since EPTC is incorporated into the soil two to four inches after application, and is highly
volatile in liquid or granular formulation, it is unlikely that a mammal will be able to consume enough
EPTC in one day to achieve the lethal does. Also, limited mortality is unlikely to have any serious
effect on the local populations of small mammals Therefore, no additional action is necessary action
at this time.
(2) Terrestrial Plant Mitigation
The level of concern is exceeded for endangered and terrestrial plants species such as
monocots and dicots . Non-target terrestrial plants in adjacent fields or habitats are potentially at risk
from spray drift from some uses and from runoff for all registered uses. EPTC also appears to have
the potential to be transported off site via the vapor phase as it was one of a number of residues found
in more than 25 percent of the rain samples collected in three water sheds in Minnesota. In addition,
being a herbicide, EPTC may also have an indirect effect on endangered insects by adversely affecting
the plants on which they depend.
As member of the Endangered Species Task Force, the registrant will be required to obtain
information which identifies endangered and threatened species of concern which may be found in
areas adjacent to crops treated with EPTC.
Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
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management practices. The Agency is now requiring interim measures for aerial applications that
must be placed on product labels/labeling as specified in Section V . The Agency has completed its
evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S.
pesticide registrants, and is developing a policy on how to apply the data and the Ag DRIFT
computer model to its risk assessments. After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target drift and risks associated with
aerial as well as other application types where appropriate. In the interim the following spray drift
related language is required on product labels that are applied outdoors in liquid sprays (except
mosquito adulticides), regardless of application method: "Do not allow this product to drift".
V. Actions Required of Registrant
A. Data Requirements
The registrant will also be required to provide additional confirmatory data as following:
Guideline:
870.6300
860.1340
860.1360
860.1380
860.1520
860.1500
Guideline:
850.2100
850.2300
850.1010
850.1025
850.1035
850.1045
850.1300
835.4300
835.8100
835.1240
Developmental neurotoxicity study in the rat
Residue Analytical methods-Plant
Multiresidue Method
Storage Stability Data
Processed Food/ Feed
Crop field Trials
Study:
Acute Avian Oral (quail/duck)
Avian Reproduction (quail/duck)
Invertebrate toxicity
Estu/mari tox mollusk
Estu/mari tox shrimp
Estu/mari tox fish
Life cycle invertebrate
Aerobic Aquatic Metabolism
Field Volatility
Leach/adsorption/deportation
B. Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the labeling of
all end-use products containing EPTC. For the specific labeling statements, refer to the table below.
A summary of EPTC labeling requirements which mitigate occupational handler risk are
stated in the following table.
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
Manufacturing Use Products
Required on all MAPS
"Only for formulation into herbicide products intended for the following use(s):" [registrants inserts uses that
are being supported by MP registrant]. " This product may not be formulated into liquid products intended for
residential consumer use."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for specific use or all
additional uses supported by
a formulator or user group.
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of
such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of
such use(s)."
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"This chemical is toxic to mammals. Do not discharge effluent containing this product into lakes, streams,
ponds estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior
to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying
the local sewage treatment plant authority. For guidance contact your state Water Board or Regional Office of
the EPA."
End Use Products Intended for Occupational Use (Label Contains WPS Uses)
RED PPE Requirements1 for
Emulsifiable Concentrate
Products:
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are listed below. If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance
category selection chart."
Mixers, Loaders and Handlers exposed to the concentrate must wear:
~ Long-sleeved shirt and long pants
~ Chemical resistant gloves such as" (registrants inserts correct gloves)
"— Chemical resistant apron
~ Chemical resistant footwear and socks
In addition to the above PPE, persons mixing and loading into chemigation systems, must wear a NIOSH
approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH
approved respirator with an (OV) cartridge, or
- a canister with any N2,R,P or HE prefilter
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
RED PPE Requirements1 for
Emulsifiable Concentrate
Products: (continued)
Applicators and other handlers exposed to the dilute must wear:
~ Long-sleeved shirt & long pants
~ Shoes plus socks
In addition to the above PPE, applicators using back-pack or hand-held equipment must wear chemical
resistant gloves such as" (registrant inserts correct gloves).
"In addition to the above PPE, applicators applying dry-bulk fertilizer with a specialized truck designed to
treat more that 80 acres, must wear a NIOSH approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH
approved respirator with an (OV) cartridge, or
- a canister with any N2,R,P or HE prefilter"
* If the product contains oil or bears instructions that will allow application with an oil-containing material,
the "N" designation must be dropped.
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are listed below. If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance
category selection chart."
Loaders, applicators (except when using a belly grinder) flaggers and other handlers must wear:
~ Long-sleeved shirt and long pants
~ Shoes plus socks
In addition to the above PPE, applicators using a push-type spreader chemical resistant gloves such as"
(registrant inserts correct gloves)
"In addition to the above PPE, loaders supporting aerial applications must wear a NIOSH approved Respirator
with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH
approved respirator with an (OV) cartridge, or
- a canister with any N2,R,P or HE prefilter
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
RED PPE Requirements1 for
Granular Products
(continued)
Applicators using a belly grinder (hand-held broadcast spreader) must wear:
~ Coveralls over long-sleeved shirt and long pants
~ Chemical resistant gloves such as (Registrant inserts correct gloves)
~ Chemical resistant footwear and socks"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist,
use detergent and hot water. Keep and wash PPE separately from other laundry."
For granular products also add:
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (immediately
following the PPE
requirements)
Engineering Controls for
Granular Products
"Engineering Controls
Aerial applicators must be in an enclosed cockpit.
When handlers use closed systems or enclosed cabs in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-5), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (immediately
following PPE and User
Safety Requirements.)
Engineering Controls for EC
Products
"Engineering Controls
Commercial (for-hire) handlers engaged in impregnating this product into dry bulk fertilizer must:
~ use a closed system that meets the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides (40 CFR 170.240(d)(4), and
~ wear the personal protective equipment required for mixers/loaders, except shoes may be substituted
for chemical-resistant footwear, and
~ have immediately available for use in case of an accident a NIOSH-approved respirator with:
~ an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or
~ a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH
approved respirator with an (OV) cartridge, or
~ a canister with any N2,R,P or HE prefilter.
When other handlers use closed systems or enclosed cabs in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-5), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (immediately
following PPE and User
Safety Requirements.)
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on
clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box.)
Environmental Hazards
"Environmental Hazards
This chemical is toxic to mammals. Do not apply directly to water, or to area where water is present or to
intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or
disposing of equipment washwaters."
Precautionary
Statements under
Environmental Hazards
Restricted-Entry Interval
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of:
12 Hours."
Directions for Use,
Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that
involves contact with anything that has been treated, such as plants, soil, or water, is:
~ coveralls
~ chemical resistant gloves
~ socks and shoes"
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or through drift.
Only protected handlers may be in the area during application."
Place in the Direction
for Use directly above
the Agricultural Use
Box.
Spray drift language that
must be placed on each
product that can be applied
aerially:
"Aerial Spray Drift Management
Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of many
equipment-and-weather-related factors determine the potential for spray drift. The applicator and the grower
are responsible for considering all these factors when making decisions."
Directions for Use
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
General Application
Restriction for products
applied as liquid sprays
(regardless of type of
application equipment)
"Do not allow this product to drift"
Place in the Direction
for use
The following language must
be placed on each product
that can be applied aerially:
"The following drift management requirements must be followed to avoid off-target drift movement from
aerial applications to agricultural field crops. These requirements do not apply to forestry applications, public
health uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the wingspan or
rotor.
2. Nozzles must always point backward parallel with the air stream and never be pointed downwards more
than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the Aerial Drift
Reduction Advisory Information."
Directions for Use
The following language must
be placed on each product
that can be applied aerially
Aerial Drift Reduction Advisory
This section is advisory in nature and does not supersede the mandatory label requirements.
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The best drift management strategy
is to apply the largest droplets that provide sufficient coverage and control. Applying larger droplets reduces
drift potential, but will not prevent drift if applications are made improperly, or under unfavorable
environmental conditions (see Wind, Temperature and Humidity, and Temperature Inversions)."
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
The following language must
be placed on each product
that can be applied aerially:
'CONTROLLING DROPLET SIZE
Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with higher rated
flows produce larger droplets.
Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many nozzle types lower
pressure produces larger droplets. When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream produces larger
droplets than other orientations and is the recommended practice. Significant deflection from horizontal will
reduce droplet size and increase drift potential.
Nozzle Type - Use a nozzle type that is designed for the intended application. With most nozzle types,
narrower spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream nozzles
oriented straight back produce the largest droplets and the lowest drift."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or rotor length may
further reduce drift without reducing swath width."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
'APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top of the largest plants unless a
greater height is required for aircraft safety. Making applications at the lowest height that is safe reduces
exposure of droplets to evaporation and wind."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be displaced downward. Therefore, on the up
and downwind edges of the field, the applicator must compensate for this displacement by adjusting the path
of the aircraft upwind. Swath adjustment distance should increase, with increasing drift potential (higher
wind, smaller drops, etc.)"
Directions for Use
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
The following language must
be placed on each product
that can be applied aerially:
"WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including droplet size and
equipment type determine drift potential at any given speed. Application should be avoided below 2 mph due
to variable wind direction and high inversion potential. NOTE: Local terrain can influence wind patterns.
Every applicator should be familiar with local wind patterns and how they affect spray drift."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift potential is high. Temperature
inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated
cloud. This cloud can move in unpredictable directions due to the light variable winds common during
inversions. Temperature inversions are characterized by increasing temperatures with altitude and are
common on nights with limited cloud cover and light to no wind. They begin to form as the sun sets and often
continue into the morning. Their presence can be indicated by ground fog; however, if fog is not present,
inversions can also be identified by the movement of smoke from a ground source or an aircraft smoke
generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions)
indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good vertical air
mixing."
Directions for Use
The following language must
be placed on each product
that can be applied aerially:
"SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent sensitive areas (e.g. residential
areas, bodies of water, known habitat for threatened or endangered species, non-target crops) is minimal (e.g.
when wind is blowing away from the sensitive areas)."
Directions for Use
End Use Products Intended for Occupational Use (Label Contains Non-WPS Uses Only)
RED PPE Requirements1 for
Emulsifiable Concentrate
Products:
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are listed below. If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance
category selection chart."
Mixers, Loaders and Handlers exposed to the concentrate must wear:
~ Long-sleeved shirt and long pants
~ Chemical resistant gloves such as (registrant inserts correct gloves)
- Chemical resistant apron
~ Chemical resistant footwear and socks
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Required Labeling
Placement on Label
RED PPE Requirements1 for
Emulsifiable Concentrate
Products: (continued)
Applicators and other handlers exposed to the dilute must wear:
~ Long-sleeved shirt & long pants
~ Shoes plus socks
~ Chemical resistant gloves when using back-back or hand-held equipment"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
RED PPE Requirements1 for
Granular Products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are listed below. If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance
category selection chart."
Loaders, applicators (except when using a belly grinder) and other handlers must wear:
~ Long-sleeved shirt and long pants
~ Shoes plus socks
~ Chemical resistant gloves such as" (registrant inserts correct gloves) "when using a push-type spreader
Applicators using a belly grinder (hand-held broadcast spreader) must wear:
~ Coveralls over long-sleeved shirt and long pants
~ Chemical resistant gloves such as" (Registrant inserts correct gloves)
" ~ Chemical resistant footwear and socks"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist,
use detergent and hot water. Keep and wash PPE separately from other laundry."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (immediately
following the PPE
requirements)
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on
clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box.)
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Environmental Hazards
Entry Restrictions for EC
Products
Restricted Interval for
Granular Products
General Application
Restrictions
Site Specific Application
Restrictions
Entry Restrictions
General Application
Restrictions
General Use Restrictions
Required Labeling
"Environmental Hazards
This chemical is toxic to mammals. Do not apply directly to water, or to area where water is present or to
intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or
disposing of equipment washwaters."
"Do not enter or allow others to enter until sprays have dried and incorporation (if required) is complete."
"Do not enter or allow other to enter the treated area (except those persons involved in the incorporation) until
the incorporation is complete following application. If the incorporation is accomplished by watering-in, do
not enter or allow others to enter the treated area until the surface is dry following the watering-in."
"Do not apply this product in a way that will contact workers or other persons, either directly or through drift.
Only protected handlers may be in the area during application."
"For professional use only. Not for use by residential consumers."
End-Use Products Intended for Residential/Consumer Users Only
"Do not allow people or pets to enter treated area (except those persons involved in the incorporation) until
incorporation is complete following application. If the incorporation is accomplished by watering-in, do not
enter or allow others to enter the treated area until the surface is dry following the watering-in."
"Do not apply this product in a way that will contact people or pets."
"Not for professional use. For use by residential consumers only. "
Placement on Label
Precautionary
Statements under
Environmental Hazards
Directions for Use
Under General
Precautions and
Restrictions
Directions for Use
under General
Precautions and
Restrictions
Place on the Front
Panel and in the
Direction for Use under
General Precautions
and Restrictions
Directions for Use
Under General
Precautions and
Restrictions
Place on the Front
Panel and in the
Direction for Use under
General Precautions
and Restrictions
92
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Table 32. Summary of RED Labeling Requirements for EPTC
Description
Specific Application
Restrictions
Specific Application
Restrictions
Other use Application
Restrictions
General Labeling Restriction
Specific Use Restrictions
Required Labeling
"Do not use a belly grinder (hand-held broadcast equipment) when applying this product"
Labels must be amended to reflect that the maximum application rate of 5 Ibs a.i/acre per application for
any granular product for residential consumer ornamental garden.
For "Peas" remove limitation on peas intended for processing only. For cotton, the maximum use seasonal
use rate is 2 Ibs per AI/A.
"Keep off sidewalks, driveways, patios, or similar surfaces".
Only granular products may be registered for use by residential consumers. Any EC products registered for
such use will be voluntarily canceled by the registrant.
Placement on Label
Directions for Use
Under General
Precautions and
Restrictions
Directions for Use
Under General
Precautions and
Restrictions
! 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.
2 If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped.
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.
93
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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 EPIC products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant
may distribute or sell such products for 50 months from the date of the issuance of this RED.
Registrants and persons other than registrant remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or distribute.
94
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VI. APPENDICES
95
-------
96
-------
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
EPTC Maximum Use Table
Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Alfalfa
Pieplant
Soil incorporated
Ground
Postplant/postemergence
Irrigation
Postemergence
Ground/Aerial
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
10% G
20% G
G Rate By Region2
National=3.0-4.0;
N/PNW/W=4.0
EC Rate By Region
N/PNW/W=2.0-4.0;
SE=1.5 in SC; 3.0 in other areas
within SE;
SW=3.0;AZ/CA=2.0-4.0
EC Rate By Region
N/SW=2.0-3.0;
W/PNW=2.0-3.0;
AZ/CA=2.0-3.0
G Rate By Region
W (except NV)=2.0-3.0
1
1 per cutting for W
Region
1 per cutting or per
30-day interval
14
14
14
Application of spray formulation may be made in 10-50
gallons of water per acre (GPA). Do not apply if a grass or a
grain crop is to be planted with the legume crop.
Application may be made to established alfalfa plants by
metering the recommended dosage into the irrigation water.
Application should be followed by irrigation (flood or
sprinkler) .
Almonds
Postemergence
Irrigation
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
W=2.2-3.0;
AZ/CA=3.0
2
14
16
Application may be made after the last cultivation for the
season by metering the recommended dosage into the
irrigation water.
Beans (Succulent or Dry)
Fall treatment
Soil incorporated
Ground
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate=4.0-4.5
EC Rate=4.0-4.5
1
45
Use limited to dry beans grown in MN and ND. Application
of spray formulation may be made in 10-50 GPA. Do not
apply to the following types of beans: adzuki, cowpeas
(blackeyed peas and blackeyed beans), soybeans, lima,
mung, Garbanzo, or other flat-podded beans except Romano.
97
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Site
Application Timing
Application Type
Application Equipment
Pieplant (including bed
treatment) or at-planting
Soil incorporated
(including subsurface)
Ground
Formulation
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
Single Application Rate (Ib ai/A)
G Rate By Region
National=3.0
N/PNW=4.0
EC Rate By Region
N/PNW=3.0-4.0;
SE=1. 5-3.0;
W/SW=3.0;
AZ/CA=3.0
Maximum Number
of Applications Per
Season
1 for small white
beans or green
beans grown on
coarse textured
soils
Preharvest
Interval, Days
45
Use Directions and Limitations '
Application of spray formulation may be made in 10-50
GPA. Do not apply to the following types of beans: adzuki,
cowpeas (blackeyed peas and blackeyed beans), soybeans,
lima, mung, Garbanzo, or other flat-podded beans except
Romano. Some liquid formulations may be tanked mix with
alachlor, ethalfluralin, metolachlor, pendimethalin, and
trifluralin. Plant beans 7 days following band and broadcast
treatments to beds.
Beans (continued)
Postemergence
Layby - soil
incorporated or
subsurface injection
Ground
Postemergence
Irrigation
5%G
20% G
6 Ib/gal EC
7 Ib/gal EC
7 Ib/gal EC
GRate
2.0-6.0
EC Rate By Region
N/W/PNW=3.0-4.0;
SE/SW=3.0;
AZ/CA=3.0
EC Rate by Region
N/SE/W/SW/PNW= 3.0-4.0
1 for small white
beans or green
beans grown on
coarse textured
soils
1
45
45
Directed spray application (using 10-50 GPA) to soil should
be made at the base of the plants before bean pods start to
form. Do not apply to the following types of beans: adzuki,
cowpeas (blackeyed peas and blackeyed beans), soybeans,
lima, mung, Garbanzo, or other flat-podded beans except
Romano. Some liquid formulations may be tanked mix with
alachlor, ethalfluralin, metolachlor, pendimethalin, and
trifluralin.
Use limited to dry beans. Application of spray formulation is
metered into irrigation water after clean cultivation. Do not
apply to the following types of beans: adzuki, cowpeas
(blackeyed peas and blackeyed beans), soybeans, lima,
mung, Garbanzo, or other flat-podded beans except Romano.
Some liquid formulations may be tanked mix with alachlor,
ethalfluralin, metolachlor, pendimethalin, and trifluralin.
Beet, Garden
Preplant
Soil incorporated
Ground
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
PNW=2.0
1
14
98
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Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Beet, Sugar
Fall treatment
Soil incorporated
Ground
Preplan!
Soil incorporated
Ground
Postemergence/post-
thinning
Irrigation
Postemergence/post-
thinning
Soil incorporated or
subsurface injection
Ground
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate=4.0-4.5
EC Rate=4. 0-4.6
EC Rate By Region
IA/MN/M/NE/ND/SD
=1.5-3.0
EC Rate By Region
N/SW/PNW/W=
2.0-3.0;
AZ/CA=2.0-3.0
G Rate By Region
National=3.0
EC Rate By Region
N/PNW=1. 5-3.0;
SW=2.0-3.0; W=3.0
AZ/CA=1. 5-3.0
1
1
2forW/PNW
Regions
1
49
49
49 for PNW
49 for PNW
Application of spray formulation may be made in 10-50
GPA. Some liquid formulations may be tank mixed with
cycloate.
Application of spray formulation may be made in 10-50
GPA. Some liquid formulations may be tank mixed with
cycloate.
Application should be made into the first irrigation after the
last cultivation of the season. Some liquid formulations may
be tank mixed with cycloate.
Application should be made after first true leaves have
formed. Some liquid formulations may be tank mixed with
cycloate.
Birdsfoot Trefoil
Preplant
Soil incorporated
Ground
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate By Region
National=3. 0-4.0;
N/PNW/W=4.0
EC Rate By Region
N=3.0-4.0;
SE=3.0;
SW=3.0;
W/PNW=2.0-4.0;
AZ/CA=2.0-4.0
I4
16
Application of spray formulation may be made in 10-50
GPA. Application is prohibited if a grass or a grain crop is
to be planted with the legume crop.
Castor Beans
Postplant
Soil incorporated
Ground
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
N=2.0
1
16
Application of spray formulation may be made in 10-50
GPA.
99
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Citrus Fruits (Including Grapefruit, Oranges, and Tangerines)
Postemergence
Irrigation
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
SE/SW/W=2.6-3.0;
AZ/CA=3.0
1
14 for W Region
1 5 for all Regions
on all other labels
Application of spray formulation may be made by metering
in flood or furrow irrigation.
Citrus Fruits (Nursery Stock in Nonbearing Groves)
Postemergence
Directed spray
Ground
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate By Region
National=3. 0-6.0
EC Rate By Region
SE/SW/W=3.0-6.0;
AZ/CA=3.0-6.0
1
15
Application of spray formulation may be made after "lining
out" in 10-50 GPA.
Clover (including Ladino Clover)
Preplan!
Soil incorporated
Ground
Postemergence
Irrigation
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
G Rate By Region
National=3. 0-4.0;
N/PNW/W=4.0
EC Rate By Region
N=3.0-4.0;
SE=3.0;
SW=3.0;
PNW/W=2.0-4.0;
AZ/CA=2.0-4.0
EC Rate By Region
N/SW/PNW/W=
2.0-3.0;
AZ/CA=2.0-3.0
I4
1
15
45
Application of spray formulation may be made in 10-50
GPA. Do not apply if a grass or a grain crop is to be planted
with the legume crop.
Application should be made to established ladino clover
plants by metering the recommended dosage into the
irrigation water.
100
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Corn (Field and Sweet)
Pieplant
Soil incorporated
Ground, irrigation, or
subsurface injection
Postplant
Broadcast soil
incorporated
Ground
Preemergence
Soil incorporated
Ground
10% G
25% G
5 Ib/gal EC
6 Ib/gal EC
6 Ib/gal EC
5%G
10% G
6 Ib/gal EC
G Rate By Region
PNW=2.0
NE/MidW/S/W=4.0-6.0
EC Rate By Region
N=3.0-4.0; PNW=2.0-3.0;
E/Central/ W (except
AZ/CA)/AZ/CA = 3.0-6.0;
All regions except
AZ/CA/FL=3.2-5.6
MidW/NE/SE=2.0-3.0
G Rate By Region
N/SE=2.0-3.0
EC Rate By Region
N/SE=2.0-3.0
I4
1
1
45
45
45
Application of spray formulation may be made in 10-60
GPA. Some liquid formulations may be tank mixed with
atrazine, cyanazine, or simazine. Delay planting of com for
7-10 days following treatment.
Application of spray formulation may be made in 10-50
GPA.
Corn (Pop)
Preplant
Soil Incorporated
Ground, irrigation, or
subsurface injection
Postplant
Soil incorporated
Ground
25% G
5 Ib/gal EC
6 Ib/gal EC
6 Ib/gal EC
5%G
G Rate By Region
NE/MidW/S/W=4.0-6.0
EC Rate By Region
E/Central/ W (except
AZ/CA)/AZ/CA=
3.0-6.0;
All regions except
AZ/CA/FL=3.2-5.6
MidW/NE/SE=2.0-3.0
I4
1
45
45
Application of spray formulation may be made in 10-60
GPA. Some liquid formulations may be tanked mixed with
atrazine, cyanazine, or simazine
101
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Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Cotton
At-planting
Ground (subsurface
injection or sweep)
Postemergence
Soil incorporated
Ground (subsurface
injection or sweep)
6 Ib/gal EC
10% G
[
20% G
[
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
SE=1.5
G Rate By Region
AZ/CA=2.0
EC Rate By Region
SE/SW=2.0
1
1
30
30
Use limited to non-irrigated cotton plants. Application of
spray formulation may be made in 10-50 GPA.
Use limited to non-irrigated cotton plants. Application of
spray formulation should be made when cotton plants have 2
to 4 leaves using 10-50 GPA.
Flax
Fall treatment
Soil incorporated
Ground
Preplant
Soil incorporated
Ground
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region N=4.0-4.6
EC Rate By Region
PNW=3.0
1
I4
45
45
Use limited to flax grown in MN and ND. Application of
spray formulation may be made in 10-50 GPA.
Application of spray formulation may be made in 10-50
GPA.
Lespedeza
Preplant
Soil incorporated
Ground
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate By Region
National=3.0-4.0;
N/PNW/W=4.0
EC Rate By Region
N=3.0-4.0;
SE=3.0;
SW=3.0;
W/PNW=2.0-4.0;
AZ/CA=2.0-4.0
I4
45
Application of spray formulation may be made in 10-50
GPA. Do not apply if a grass or a grain crop is to be planted
with the legume crop.
Peas (Succulent)
Preplant
Soil incorporated
Ground
6 Ib/gal EC
7 Ib/gal EC
2.0
I4
45
Use limited to green peas grown in Western WA for
processing. Application of spray formulation may be made
in 10-50 GPA.
102
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Potatoes (Irish)
Fall treatment
Soil incorporated
Ground
Preplant/at-
planting/drag-off,
(before or after bed
formation)
Soil incorporated
Ground
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate= 4.0-4.5
EC Rate= 4.5-6.0
GRate
National=3. 0-6.0;
SE/SW/W=3.0;
N/PNW=3.0-6.0
EC Rate By Region
SE/W=1. 5-3.0
PNW=3.0-4.0
N/SW=3.0-6.0
AZ/CA=3.0
1
I4
45
45
Use limited to potatoes grown in MN and ND. Application
of spray formulation may be made in 10-50 GPA.
Application of spray formulation may be made in 10-50
GPA. Some liquid formulations may be tank mixed with
metribuzin and rimsulfuron.
Potatoes (continued)
Postemergence
Layby - soil incorporated
Ground
Postemergence
Layby - irrigation
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
GRate
National=4.0
SE/SW/W=3.0
N/PNW=3.0-4.0
EC Rate By Region
N/W=3.0-4.0;
SE=3.0;
SW/PNW=3.0-6.0;
W=3.0-4.0;
AZ/CA/TD/OR/WA=
3.0-4.0
EC Rate By Region
N/SW/SE/PNW/W=3.0
AZ/CA=3.0
ID/OR/WA=3.0-6.0
1
1
45
30 for W Region
45 for other
regions
Directed spray application to soil may be made in 10-50
GPA. Some liquid formulations may be tank mixed with
metribuzin and rimsulfuron.
Application of spray formulation may be made into the
irrigation water after clean cultivation. Some liquid
formulations may be tank mixed with metribuzin and
rimsulfuron.
103
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Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Safflower
Pieplant
Soil incorporated
Ground
Postemergence
Irrigation
5%G
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
7 Ib/gal EC
GRate
National=3.0
EC Rate By Region
N/PNW/W=3.0;
AZ/CA=3.0
EC Rate By Region
AZ/CA=3.0
I4
2
not stated 3
60
Application of spray formulation may be made in 10-50
GPA.
Use limited to AZ and CA. Application may be made using
flood, furrow, or sprinkler irrigation systems.
Strawberries
Postplant
Soil incorporated
Ground
Postemergence
Soil incorporated
Ground
5%G
5%G
4.0
4.0
1
1
not stated 3
1
Use limited to strawberries grown in KY, NY, OH, PA, and
WV. Application should be made after plants have
developed new roots and leaves (a minimum of 4 weeks after
planting).
Use limited to strawberries grown in TN. Application
should be made on well-established plants. For new beds,
application should be made 3 to 4 weeks after planting. For
old beds, application may be made after harvest when beds
are clean. Do not apply later than the first bloom, or to
plants that will be tarped or mulched.
Sunflower
Fall treatment
Soil incorporated
Ground
Preplant (spring)
Soil incorporated
Ground
10% G
20% G
6 Ib/gal EC
7 Ib/gal EC
20% G
6 Ib/gal EC
7 Ib/gal EC
G Rate=4.0-4.5
EC Rate=4. 0-4.6
G Rate By Region:
CO/KS/MN/NE/ND/SD=2.0-3.0
EC Rate By Region
CO/KS/MN/MS/ND/SD=2.2-3.0
1
I4
1
not stated 3
Use limited to sunflowers grown in MN and ND.
Application of spray formulation may be made in 10-50
GPA.
Application of spray formulation may be made in 10-50
GPA. Some liquid formulations may be tank mixed with
trifluralin.
104
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Site
Application Timing
Application Type
Application Equipment
Formulation
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Use Directions and Limitations '
Sweet Potato
Preplant-bed over/up
Soil incorporated
Ground
Postplant
Broadcast spray
Ground
6 Ib/gal EC
7 Ib/gal EC
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
SE/SW=1. 5-3.0
EC Rate By Region
SE/SW=7.0-7.5
I4
1
not stated 3
1
Application of spray formulation may be made in 10-50 GPA
Application should be made immediately after planting (or
within 2 days after planting slips or vine cuttings) using 10-
50 GPA.
Tomatoes
Postemergence layby
Soil incorporated
Ground
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
W/PNW=3.0
1
21
Use limited to Northern CA counties (Butte, Colusa, Contra
Costa, Glen, Merced, Sacramento, San Joaquin, Solano,
Stanislaus, Sutler, Yolo, and Yuba). Application of spray
formulation may be made in 10-50 GPA. Do not use where
grain will be planted within 90 days. Do not irrigate for at
least 5 days after application.
Walnut
Postemergence
Irrigation
6 Ib/gal EC
7 Ib/gal EC
EC Rate By Region
PNW/W=3.0;
AZ/CA=3.0
1
Application of spray formulation may be made into the
irrigation water during the entire irrigation period.
Fallow Land
Preplant
Soil incorporated
Ground
10% G
20% G
7 Ib/gal EC
3.0-6.0
1 4
not stated 3
AZ SLNs: For use on idle season fallow land from June to
September. Crop areas must be irrigated at least 30 days
prior to planting. Do not plant cotton or crops not listed on
the parent label within 90 days after application.
CA SLN: Use limited to Imperial, Riverside, and San
Bernardino counties of CA for use on fallow land from June
to September prior to planting of carrots, cotton, and lettuce.
Crop areas must be irrigated at least 30 days prior to
planting. Do not plant carrots, cotton, or lettuce within 90
days after application.
105
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Site
Application Timing
Application Type
Application Equipment
Site
Application Timing
Application Type
Application Equipment
Formulation
Formulation
Single Application Rate (Ib ai/A)
Single Application Rate (Ib ai/A)
Maximum Number
of Applications Per
Season
Maximum Number
of Applications Per
Season
Preharvest
Interval, Days
Preharvest/
Programing
Interval, Days
Use Directions and Limitations '
Use Directions and Limitations '
Ornamental (Commercial)
Pieplant
Postplant
Soil incorporated
2.3% G
5.1b ai/A
I4
not stated 3
Preplant broadcast. Preplan! band application. Postplant
application:
nursery cultivator or rototiller.
Ornamental(Residential)
Preplan!
Postplant
Soil incorporated
2.3% G
5.1b ai/A
I4
not stated 3
Preplant application- Rototiller. Postplant application-For
annual weed
use, hand rake or hoe or water in immediately after
application to a dept of 2 to 3 inches. Belly Grinder use for
residential application is prohibited.
The restricted entry interval is 12 hours. The label for the 5.6 Ib/gal EC formulation (EPA Reg. No. 10182-388) specifies the following rotational crop restrictions: com, soybeans,
sorghum or tobacco may be planted the spring following Preplant application; wheat may be planted 4 months after Preplant application. No other rotational crop restrictions have been
established for any other product.
Regions: E=East; N=North; SE=Southeast; SW=Southwest; W=West; MidW=Midwest; PNW=Pacific Northwest.
For single application per season labeled PLU's are not required for Preplant.
Where there was formally no maximum seasonal application rate specified, it is assumed that 1 Preplant application is sufficient.
This must be specified on label in the future.
106
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND
STUDIES USED TO MAKE THE REREGISTRATION
DECISION
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregi strati on for active
ingredients within the case EPIC covered by this RED. It contains generic data requirements that
apply EPTC in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which are available from the National
technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-
4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer
to the Bibliography appendix for a complete citation of the study.
107
-------
REQUIREMENTS
PRODUCT CHEMISTRY
61-1 (830.1550) Chemical Identity
61-2A (830.1600)
61-2B (830.1670)
62-1 (830.1700)
62-2(830.1750)
62-3 (830.1800)
63-2 (830.6302)
63-3 (830.6303)
63-4 (830.6304)
63-6 (830.7200)
63-7 (830.7300)
63-8 (830.7840)
63-9 (830.7950)
63-10 (838.7370)
63-11 (830.7550)
63-12 (830.7000)
63-13 (830.6313)
63-14(830.6314)
63-15(830.6315)
63-16 (830.6316)
63-17(830.6317)
63-18 (830.7100)
63-19(830.6319)
63-20 (830.6320)
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A (850.2100) Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
71-2A (850.2300)
71-2B (850.2200)
71-4A (850.2100)
71-4B (850.2300)
72-1A (850.1075)
USE
PATTERN
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
A,B,C,G,K
A,B,C,G,K
A,B,C,G,K
A,B,C,K
A,B,C,K
A,B,C,D,F,E
CITATION(S)
42860201
00152450,42860202
00152450,42860201
42860201,00152450
42860201
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
42120801
00144280 (Data Gap)
01311275
00144207
Data Gap
Data Gap
00131271
108
-------
72-1B (850.1075)
72-2A (850.1010)
72-3A (850.1025)
72-3B (850.1035)
72-CA(850.10$5)
72-4 (850-1350)
123-1A(850.4225)
123-16(850.4250)
123-2 (850.4250)
141-1 (850.3020)
TOXICOLOGY
81-1 (870.1100)
81-2(870.1200)
81-3(870.1300)
81-4 (870.2400)
81-5 (870.2500)
81-6 (870.2600)
81-7 (870.6100)
82-1A (870.3100)
82-16(870.3150)
82-2 (8703200)
82-3(870.3250)
82-4 (870.3465)
82-5A
82-5B (870.6201)
83-1A (870.4100)
83-1B
83-2A (870.4200)
83-2B
83-3A (870.3700)
83-3B
83-4 (870.3800)
83-6 (870.6300)
84-2A
Fish Toxicity Bluegill - TEP
Invertebrate Toxicity
Estu/mari tox mollusk
Estu/mari tox shrimp
Estu/mari tox fish
Life cycle invertebrate
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Developmental Neurotoxicity Study
Gene Mutation (Ames Test)
A,B,C,D
A,B,C,G,K
A,B,C,K
A,B,C,K
A,B,C,K
A,B,C,K
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,G,K
A,B,C,D
00021834
001312273, 00144209,42945601
(Data Gap)
Data Gap
Data Gap
Data Gap
Data Gap
42120802,
43217101
43217101
42899801,42921201
42921201,42940901
000365935
00157868
00157869
00157870
00157871
00157872
00157873
00150325
00144651
00161595
4372502
41831202
,43096001
00157870, 00154784, 41992001
00150325
42921901,43039701
43230901
00145004,00145311
00161595,40442301
40215001
4237001
00138919
40442302
0012128,00161597,
Data Gap
00152451,00152452
40420408
109
-------
84-2B
85-1 (870.7485)
Structural Chromosomal Aberration A,B,C,D
General Metabolism A,B,C,D
00152455
00085400,40614424
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A (875.2100)
132-1B (875.2200)
133-3 (875.2400)
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry Exposure
133-4 (875.2500) Inhalation Passive Dosimetry
Exposure
ENVIRONMENTAL FATE
161-1 (835.2120)
161-2 (835.2240)
161-3 (835.2410)
161-4 (835.2370)
162-1 (835.4100)
162-2 (835.4200)
162-4 (835.4300)
163-1 (835.1240)
163-2(835.1410)
163-3 (835.8100)
164-1 (860.6100)
164-5 (835.6500)
165-1(860.1850)
165-2(860.1900
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Volatility - Lab
Field Volatility
Terrestrial Field Dissipation
Long Term Soil Dissipation
Confined Rotational Crop
Field Accumulation in Rotational
A,B,C,D,H,I, J,
K
A,B,C,D,H,I, J,
K
A,B,C,D
A,B,C,D
A,B,C,D,E,F
A,B,C,D,E,F
A,B,C,J
A,B,C
A,B,C,K
A,B,C
G
A,B,C,G,K
A,B,H,I
A.B.
A,B,C,K
A,B,C,D
A,B,C,D
reserved
reserved
reserved
reserved
00141373,
42120803
4040401,
42120803
42120804
42541001
42 120805 (Data Gap, upgradable)
42120807,40430402 (Data Gap,
upgradable)
Data Gap
404420403,
42 120808 (Data Gap)
42120809
Data Gap
98250,146934,
146935,404205
42120810,42120811
00152457
Data Gap
165-4(850.1730)
166-1 (835.7100)
201-1(840.1100)
202-1 (840.1200)
Crops
Bioaccumulation in Fish A,B,C,D
Ground Water - Small Prospective A,B,C
Droplet Size Spectrum n/a
Drift Field Evaluation n/a
RESIDUE CHEMISTRY
171-4C (860.1340) Residue Analytical Method - Plants A,B,K
171-4E (860.1380) Storage Stability A,B,K
171-4F (860.1400) Magnitude of Residues - Potable H2O D,E
171-4K(860.1500) Crop Field Trials
40575101 (Data Gap, upgradable)
Satisfied by Spray Drift Task Force
Satisfied by Spray Drift Task Force
0022281,00022318 (Data Gap)
41977401,41977402 (Data Gap)
43849911
Data Gap
110
-------
Fallow fields
Root and Tuber Vegetables Group
- Beet, garden, roots
- Beet, sugar, roots
- Potato
- Sweet potato
Leaves of Root and Tuber Vegetables Group
- Beet, garden, tops (leaves)
- Beet, sugar, tops (leaves)
Legume Vegetables Group
- Bean (succulent and dry)
- Pea (succulent)
Foliage of Legume Vegetables
Group
- Bean forage and hay
- Pea vines and hay
Fruiting Vegetables (Except Cucurbits) Group
- Tomato
Citrus Group
Tree Nuts Group
- Almonds
- Walnuts
Cereal Grains Group
- Corn, field, grain and
aspirated grain fractions
A,B
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
Data Gap
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
00025035
00022249,
00022398,
00037693,
00057546,
00022150,
00025036,
00105790,
00025038
00022275,00022394,
00025033,00025037,
00037694,00037705
00067275, 43849906
00022274,00022315,
00037691,00090891,
00106797, 43849910
00025035
00022249, 00022275,00022394,
00022398, 00025033,00037693,
00037694, 00037705,00057546,
43849906
00022278, 00022312,00022369,
00022376, 00025025,00025292,
43849912-43849915
00022146, 00039198
00022272, 00022312,00022369,
00022376, 00025292,00037695,
00057547, 00057548, 00064182
00022146
00025031,43849919
00025021, 0003769 (Data Gap)
00022385, 00022399,00025034,
00078437, 43849904
00022385, 00022399,00025034,
43849905
00025032, 00098255,
41486002,41831206, 43849922
111
-------
- Corn, sweet (K+CWHR)
Forage. Fodder, and Straw of Cereal Grains Group
- Corn, field, forage and stover
- Corn, sweet, forage and stover
Non-grass Animal Feeds Group
- Alfalfa, forage and hay
- Birdsfoot trefoil, forage and
hay
- Clover, forage and hay
Miscellaneous Commodities
- Castor beans
- Cotton, seed and gin
byproducts
- Flax, seed
- Safflower, seed
- Strawberry
- Sunflower, seed
- Citrus group
860.1520: Processed Food/Feed
- Beet, sugar
- Corn, field
- Cotton, seed
- Potato
- Sunflower seed
- Tomato
171-4M (860.1360) Multiresidue Method
A,B,K 00023047,00025032, 41486002
43849920
A,B,K 00025032,00098255, 41486002
41831206, 43849922
A,B,K 00025032,41486002,43849920
A,B,K 00022145,00022311,00022386,
00025024, 41724301,41724304,
43849903
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B,K
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00025029
00025027,
00022147,
00022397,
00037698,
00022273,
00067371
00022140,
00022118,
00039203
00022276,
00057545,
Data Gap
43849907
43849921
43849916
43849911
43849909
43849918
Data Gap
, 43849901
, 00039200
, 00039200,
, 43849917
,00022314,
(Data Gap)
, 00039200,
, 00025279,
(Data Gap)
,00022316,
, 00057549,
00039201,
(Data Gap)
43849902
00039200,
43849908
112
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Appendix C. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of
a citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard
of the American National Standards Institute (ANSI), expanded to provide for certain special
needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show
a personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
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
113
-------
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.
114
-------
BIBLIOGRAPHY
MRID
CITATION
00021834 Knott, W.; Bellies, R.P. (1967) Eptam Safety Evaluation on Fish and Wildlife:
Bobwhite Quail, Rainbow Trout, and Bluegill Sunfish. (Unpublished study received
Mar 27, 1972 under unknown admin, no.; prepared by Woodard Research Corp.,
submitted by Stauffer Chemical Co., Richmond, Calif; CDL:120329-S)
00022361 Knott, W.; Bellies, R.P. (1967) Knoxweed 42 Safety Evaluation on Fish and Wildlife:
Bobwhite Quail, Rainbow Trout, and Bluegill Sunfish. (Unpublished study received
Oct 12, 1967 under unknown admin, no.; prepared by Woodard Research Corp.,
submitted by Stauffer Chemical Co., Richmond, Calif; CDL:110074-A)
00025286 McCann, J.A. (1972) [Eptam: Toxicity to Rainbow Trout]: Test No. 461. (U.S.
Agricultural Research Service, Pesticides Regulation Div., Animal Biology
Laboratory, unpublished report.)
00025287 McCann, J.A. (1970) [Eptam: Toxicity to Goldfish]: TestNo. 286. (U.S. Agricultural
Research Service, Pesticides Regulation Div., Animal Biology Laboratory,
unpublished report.)
00034683 McCann, J.A. (1970) [Eptam 6 E: Toxicity to Goldfish]: Test No. 294. (U.S.
Agricultural Research Service, Pesticides Regulation Div., Animal Biology
Laboratory, unpublished report.)
00034684 McCann, J.A. (1970) [Eptam 6 E: Toxicity to Bluegill]: Test No. 277. (U.S.
Agricultural Research Service, Pesticides Regulation Div., Animal Biology
Laboratory, unpublished report.)
00084743 Bullock, C. (1968) Thiocarbamate Herbicides-Mosquito Fish Bioassay:
Toxicologival Summary T-1272. (Unpublished study received Oct 8, 1981 under
476-2107; submitted by Stauffer Chemical Co., Richmond, Calif; CDL:246020-G)
00131271 Burgess, D.; Forbis, A. (1983) Acute Toxicity of EPTC to Bluegill Sunfish (Lepomis
macrochirus): Static Bioassay Report 30651. (Unpublished study received Oct 3,
1983 under 748-235; prepared by Analytical Bio-Chemistry Laboratories, Inc.,
submitted by PPG Industries, Inc., Barberton, OH; CDL:251432-A)
00131272 Forbis, A. (1983) Acute Toxicity of EPTC to Rainbow Trout (Salmo gairdneri):
Static Bioassay Report 30652. (Unpublished study received Oct 3, 1983 under
748-235; prepared by Analytical Biochemistry Laboratories, Inc., submitted by PPG
Industries, Inc., Barberton, OH; CDL:251432-B)
115
-------
BIBLIOGRAPHY
MRID
CITATION
00131273 Boudreau, P.; Forbis, A. (1983) Acute Toxicity of EPIC to Daphnia magna: Static
Acute Bioassay Report 30653. (Unpublished study received Oct 3, 1983 under
748-235; prepared by Analytical biochemistry Laboratories, Inc., submitted by PPG
Industries, Inc., Barberton, OH; CDL:251432-C)
00131276 Beavers, 1; Jaber, M.; Joiner, G.; et al. (1983) A Dietary LC50 in the Mallard with
EPIC: Project No. 145-114. Final rept. (Unpublished study received Oct 3, 1983
under 748-23 5; prepared by Wildlife International Ltd., submitted by PPG Industries,
Inc., Barberton, OH; CDL:251432-F)
00141373 Myers, H; Bartell, L. (1983) Hydrolysis Studies of EPIC: Report No. WRC 83-59.
Unpublished study prepared by Stauffer Chemical Co. lip.
00142894 Atkins, E. (1985) Letter sent to J. Slate dated Mar 7, 1985: (Acute contact toxicity
of Eradicane 6.7E on honey bees). Includes lab data summary sheet 657. Prepared
by Univ. of California, Riverside, Dept. of Entomology, lip.
00142895 Majeska, J. (1984) Mutagenicity Evaluation in Bone Marrow Micronucleus: Report
NO. T-l 1906. Unpublished study prepared by Stauffer Chemical Co., Environmental
Health Center. 16 p.
00142896 Vispetto, A.; Miaullis, J. (1979) Eptam Rat Metabolism: Project 148170.
Unpublished study prepared by Stauffer Chemical Co., Environmental Health Center.
27 p.
00144208 McAllister, W.; Cohle, P. (1984) Acute Toxicity of Eptam Technical to Bluegill
Sunfish (Lepomis macrochirus): Static Acute Toxicity Report #31562. Unpublished
study T-l 1450 prepared by Analytical Bio-Chemistry Laboratories, Inc. 51 p.
00144209 Forbis, A.; Burgess, D. (1984) Acute Toxicity of Eptam Technical to Daphnia magna:
Static Acute Toxicity Report #31563. Unpublished study T-l 1449 prepared by
Analytical Bio-chemistry Laboratories, Inc. 35 p.
00152457 Thomas, V.; Dennison, J. (1984) Rotational Crop Uptake of ?Radiolabeled
Carbono-Eptam Residues in Soil: MRC-84-04. Unpublished study prepared by
Stauffer Chemical Co. 19 p.
00157868 Naas, D. (1985) Acute Oral Toxicity (LD50) Study in Albino Rats with EPTC
Technical: Project No. WIL-13035: Final Report. Unpublished study prepared by
WIL Research Laboratories, Inc. 132 p.
116
-------
BIBLIOGRAPHY
MRID
CITATION
00157870 Dudek, B. (1985) Four Hour Acute Aerosol Inhalation Toxicity Study in Rats of
EPTC Technical: Report No. 420-1853. Unpublished study prepared by American
Biogenics Corp. 44 p.
00161597 Mackenzie, K. (1986) Two-generation Reproduction Study with EPTC in Rats:
Report: Study No. 6100-108. Unpublished study prepared by Hazleton Laboratories
America, Inc. 1192 p.
40215002 Ross, J. (1987) Interpretation, Exposure Assessment and Risk Assessment Based on
Monitoring Data for Agricultural Use of EPTC by the Mixer/Applicator: Lab No.:
BR-24060. Unpublished study prepared by PPG Industries, Inc. 23 p.
40222401 Knarr, R.; Iwata, Y. (1986) Application Exposure to EPTC During Ground-spray
Application of Eptam 7-E Selective Herbicide to Potato Fields. Unpublished study
prepared by Stauffer Chemical Co. 108 p.
40326302 Wiedmann, J. (1987) Genep 7E Mixer Applicator Exposure Study, Nichols Ranch,
Chico, California, 1986: Lab No.: BR 24056. Unpublished study prepared by PPG
Industries, Inc. 201 p.
40420401 Lee, K. (1987) EPTC-Photodegradation Studies in Water: Laboratory Project ID:
RRC 87-54. Unpublished study prepared by Stauffer Chemical Co. 71 p.
40420403 McBain, J. (1987) Eptam Soil Leaching Study: Document Nos. PMS-248 and
MRC-87-25. Unpublished study prepared by ICI Americas Inc. 36 p.
40420404 Cliath, M.; Spencer, W.; Farmer, W.; et al. (1980) Volatilization of S-ethyl
N,N-dipropylthiocarbamate from water and wet soil during and after flood irrigation
of an alfalfa field. Journal of Agricultural & Food Chemistry 28(3):610-613.
40420405 Curry, K. (1987) EPTAM (EPTC) 10-G Field Dissipation Study for Terrestrial Food
Crop Uses: Mississippi, 1986: Laboratory Project ID: RRC 87-81. Unpublished study
prepared by Stauffer Chemical Co. 74 p.
40420406 Curry, K. (1987) EPTAM (EPTC) 10-G Field Dissipation Study for Terrestrial Food
Crop Uses, California, 1986: Laboratory Project ID: RRC 87-82. Unpublished study
prepared by Stauffer Chemical Co. 55 p.
117
-------
BIBLIOGRAPHY
MRID
CITATION
40420407 Curry, K. (1987) Eradicane (EPIC) 6.7-E Field Dissipation Study for Terrestrial
Food Crop Uses, California, 1986: Laboratory Project ID: RRC 87-88. Unpublished
study prepared by Stauffer Chemical Co.66 p.
40420408 Zwicker, G.; Minor, J. (1987) A Two-generation Rat Reproduction Study with
EPTAM Technical: T-10123: Addendum to Final Report-Histopathology.
Unpublished study prepared by Stauffer Chemical Co. 102 p.
40442302 Gilles, P. (1987) A Teratology Study in Rabbits with Eptam Technical: T-12982:
Final Report. Unpublished study prepared by Stauffer Chemical Co. 219 p.
40575100 ICI Americas Inc. (1988) Submission of Metabolism and Accumulation Studies to
Support the Registration for Eptam. Transmittal of 2 studies.
40575101 Forbis, A. (1987) Uptake, Depuration and Bioconcentration of [Carbon 14]-Eptam
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Associates and Calcagno; CDL: 091118-F)
128
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BIBLIOGRAPHY
MRID
CITATION
00057545 Stauffer Chemical Company (1981) Eptam 7-E + Treflan 4-EC Tank Mix Applied
Preplant Incorporated to Sunflowers. (Compilation; unpublished study received Feb
13, 1981 under 476-2154; CDL: 244420-A)
00057546 Stauffer Chemical Company (1981) Eptam 7-E + Treflan 4-EC Tank Mix Applied
Postemergence Incorporated in Sugarbeets. (Compilation; unpublished study
received Feb 13, 1981 under 476-2154; CDL: 244420-B)
00057547 Stauffer Chemical Company (1979) Eptam 7-E + Treflan 4-EC Tank Mix Applied
Preplant Incorporated to Snap Beans. (Compilation; unpublished study received Feb
13, 1981 under 476-2154; CDL: 244420-C)
00057548 Stauffer Chemical Company (1980) Multiple Applications of Eptam 7-E on Snap and
Dry Beans. (Compilation; unpublished study received Feb 13, 1981 under 476-2154;
CDL:244420-D)
00057549 Stauffer Chemical Company (1980) Eptam 7-E + Amiben 2-E Tank Mix Applied
Preplant Incorporated in the Spring to Sunflowers. (Compilation; unpublished study
received Feb 13, 1981 under 476-2154; CDL:244420-E)
00064182 Ciba-Geigy Corporation (1980) [Residue of Dual 8E and Eptam 6E on Kidney Beans
and Various Other Beans]. (Compilation; unpublished study received Mar 31, 1981
under 100-597; CDL:099988-B)
00067275 Stauffer Chemical Company (1976) [Residues of Ro-neet in Sugar Beets].
(Compilation; unpublished study received Jun 22, 1977 under 476-1979;
CDL:230772-B)
00067371 Danhaus, R.G.; Mestdagh, P.; Schreurs, R.; et al. (1980) Residues of Triallate,
Trifluralin and EPTC in Oilseeds following Preemergent Applications of Far-go, Far-
go +Treflan, and Far-go + Eptam Tank Mixes: Report No. MSL-1323. Final rept.
Includes undated methods entitled: Analytical residue method for triallate and
trifluralin in oilseed crops and Analytical residue method for EPTC in flax seed.
(Unpublished
00074451 Lesh, M.R. (1979) Determination of Residues of R-33865, EPTC, Butylate and R-
25788 in Corn. Method no. RRC 79-33 dated Nov 2, 1979. (Unpublished study
received May 27, 1981 under 1F2456; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL: 070113-C)
129
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BIBLIOGRAPHY
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00078437 Stauffer Chemical Company (1981) Eptam Split Application of Almonds: Summary
of Crop Residue Data. (Compilation; unpublished study received Jul 27, 1981 under
476-2154; CDL:245620-A)
00090891 Stauffer Chemical Company (1979) [Potato Residue Data: Fonofos]. (Compilation;
unpublished study received Oct 10, 1979 under 476-2056; CDL:241112-J)
00098255 PPG Industries, Incorporated (1982) Residue Studies with PPG-1292 in Corn to
Description of the Analytical Method. Includes method dated Mar 29, 1982.
(Compilation; unpublished study received Apr 5, 1982 under 2F2666; CDL:070756-
B)
00105790 Stauffer Chemical Co. (1979) Vernam IE: Residue Data. (Compilation; unpublished
study received Mar 16, 1979 under 476-2155; CDL:237823-A)
00106797 American Cyanamid Co. (1978) Amounts of Residues of Prowl, Its Metabolite (CL
202,347) Metribuzin (Sencor or Lexone) and Eptam in or on Potatoes.
(Compilation; unpublished study received Oct 5,1978 under 241-243; CDL:097433-
A; 097434)
00152457 Thomas, V.; Dennison, J. (1984) Rotational Crop Uptake of Radio-labeled Carbon
-Eptam Residues in Soil: MRC-84-04. Unpublished study prepared by Stauffer
Chemical Co. 19 p.
40614424 Lamoureux, G.; Rusness, D. (1987) EPIC metabolism in corn, cotton, and soybean:
Identification of a novel metabolite derived from the metabolism of a glutathione
conjugate. J. of Agricultural and Food Chemistry 35(1): 1-7.
41486002 Hillebrecht, W. (1990) Residue Data Supporting the Use of Granular Formulations
of Eradicane on Corn: Report No.: R & RA #1. Unpublished study prepared by ICI
Americas, Inc. in cooperation with Stauffer Chemical Co. 114 p.
41724301 Curry, K. (1990) Eptam 10-G Magnitude of the Residue on Alfalfa Seed Following
Broadcast Application to Established Alfalfa in California: Lab Project Number:
EPTA-89-MR-03. Unpublished study prepared by ICI Americas Inc. 73 p.
41724302 Curry, K. (1990) EPTAM 10-G Magnitude of the Residue Following Ground
Application to Established Alfalfa in California and Arizona: Lab Project Number:
EPTA-89-MR-01: RR 90-3SOB. Unpublished study prepared by ICI Americas Inc.
152 p.
130
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41724303 Curry, K. (1990) EPTAM 10-G Magnitude of the Residue on Alfalfa Seed Following
Broadcast Applications to Established Alfalfa in Arizona: Lab Project Number:
EPTA-89-MR-04: RR 90-397B. Unpublished study prepared by ICI Americas Inc.
75 p.
41724304 Curry, K. (1990) EPTAM 10-G Magnitude of the Residue Following Aerial
Applications to Established Alfalfa in California and Arizona: Lab Project Number:
EPTA-89-MR-02: RR 90-395B. Unpublished study prepared by ICI Americas Inc.
146 p.
41831206 Curry, K.; Grant, C. (1991) Eradicane 25-G: Magnitude-of-the-Residue Study on
Field Corn: Lab Project Number: RR 90-438B. Unpublished study prepared by ICI
Americas Inc. 222 p.
41977401 Herman, R. (1991) Interim Report: Storage Stability Validation for EPIC in Field
Corn Grain: Lab Project Number: EPTA-90-SS-01. Unpublished study prepared by
ICI Americas Inc. 36 p.
41977402 Mckay, J. (1991) Storage Stability Validation for EPIC in Raw Agricultural
Commodities and Soil: Lab Project Number: RRC 88-82: 005801. Unpublished study
prepared by ICI Americas Inc. 70 p.
42735901 Akhavan, M.; Gao, M. (1993) EPIC: Nature of the Residue in Corn Study: Lab
ProjectNumber: RR93-005B: PMS 348. Unpublished study prepared by Zeneca, Inc.
104 p.
42735902 Ortiz, D. (1993) EPIC: Nature of the Residue in Potatoes: Lab Project Number:
PMS351: RR 92-083B. Unpublished study prepared by Zeneca, Inc. 118 p.
42735903 Akhavan, M. (1993) EPIC: Nature of the Residue in Pinto Bean Study: Lab Project
Number:PMS350:RR93-042B. Unpublished study prepared by Zeneca, Inc. 121
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42964101 Ortiz, D. (1993) Addendum to EPIC: Nature of the Residue in Potatoes: Lab Proj ect
Number: PMS 351: RR 92-083B RES: WIN0882. Unpublished study prepared by
ZENECA Inc. 27 p.
42964102 Akhavan, M.; Gao, M. (1993) Addendum to EPIC: Nature of the Residue in Corn
Study: Lab Proj ect Number: PMS 348: RR 93-005B RES: WIN0880. Unpublished
study prepared by ZENECA Inc. 24 p.
131
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42964103 Akhavan, M.; Gao, M. (1993) Addendum to EPIC: Nature of the Residue in Pinto
Beans: Lab Project Number: PMS 350: RR93-042B RES:WIN0881. Unpublished
study prepared by ZENECA Inc. 19 p.
43609801 Ortiz, D.; Akhavan, M.; Moriarty, J. (1995) EPIC: The Nature of the Residues of
Orally Administered (N-propyl-1-(carbon 14))- EPTC in Tissues and Milk of
Lactating Goat: Lab Project Number: RR-94-075B: PMS 381: WIN 2698.
Unpublished study prepared by Zeneca Ag Products; Analytical Development Corp.;
and Colorado State University. 185 p.
43609802 Akhavan, M.; Moriarty, J.; Ortiz, D. (1995) EPTC: The Nature of the Residues of
Orally Administered (N-propyl-1-(carbon 14))- EPTC in Tissues and Eggs of Laying
Hens: Lab Project Number: RR-94-074B: PMS 380: WIN 2699. Unpublished study
prepared by Zeneca Ag Products; Analytical Development Corp.; and Colorado State
University. 179 p.
43849901 Francis, P.; Grant, C. (1995) EPTC: Magnitude of the Residue Study on Clover after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-044B: EPTC-93-MR-03:
02-CA-93-121. Unpublished study prepared by Zeneca Ag Products. 65 p.
43849902 Storoni, H. (1995) EPTC: Magnitude of the Residue Study on Safflower Seed after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-053B: EPTC-93-MR-09:
EPTC-94-MR-01. Unpublished study prepared by Zeneca Ag Products. 50 p.
43849903 Francis, P.; Grant, C. (1995) EPTC: Magnitude of the Residue Study on Alfalfa after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-052B: EPTC-92-MR-01:
EPTC-93-MR-01. Unpublished study prepared by Zeneca Ag Products. 77 p.
43849904 Francis, P.; Grant, C. (1995) EPTC: Magnitude of the Residue Study on Almonds
after Treatment with EPTAM 7-E: Lab Project Number: RR 95-055B: EPTC-93-
MR-02: 02-CA-93-111. Unpublished study prepared by Zeneca Ag Products. 69 p.
43849905 Francis, P.; Grant, C. (1995) EPTC: Magnitude of the Residue Study on Walnuts
after Treatment with EPTAM 7-E: Lab Project Number: RR 95-056B: EPTC-93-
MR-12: 18-CA-93-211. Unpublished study prepared by Zeneca Ag Products. 54 p.
43849906 Roper, E. (1995) EPTC: Magnitude of the Residue Study on Sugar Beets after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-074B: EPTC-92-MR-04:
EPTC-93-MR-10. Unpublished study prepared by Zeneca Ag Products. 60 p.
132
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43849907 Robbins, J. (1995) EPIC: Processing Study on Sugar Beets from a Trial Conducted
in Idaho During 1992: Lab Project Number: RR 95-079B: EPTC-92-PR-04: 16-ID-
92-227. Unpublished study prepared by Zeneca Ag Products. 79 p.
43849908 Francis, P.; Grant, C. (1995) EPIC: Magnitude of the Residue Study on Sunflowers
after Treatment with EPTAM 7-E: Lab Project Number: RR 95-041B: EPTC-93-
MR-11: 78-MN-93-201. Unpublished study prepared by Zeneca Ag Products. 52
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43849909 Robbins, J. (1995) EPIC: Processing Study on Sunflower Seed from a Trial
Conducted in South Dakota During 1992: Lab Project Number: RR95-067B: EPTC-
92-PR-05: 3 l-SD-92-262. Unpublished study prepared by Zeneca Ag Products. 85
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43849910 Roper, E. (1995) EPTC: Magnitude of the Residue Study on Potatoes after
Treatment with EPTAM 7-E: Lab Proj ect Number: RR 95-066B: EPTC-92-MR-03:
EPTC-93-MR-08. Unpublished study prepared by Zeneca Ag Products. 60 p.
43849911 Storoni, H. (1995) EPTC: Processing Study on Potatoes from a Trial Conducted in
Washington During 1992: Lab Proj ect Number: RR95-073B: EPTC-92-PR-03: 15-
WA-92-216. Unpublished study prepared by Zeneca Ag Products. 91 p.
43849912 Francis, P.; Grant, C. (1995) EPTC: Magnitude of the Residue Study on Snap Beans
after Treatment with EPTAM 7-E: Lab Project Number: RR 95-014B: EPTC-92-
MR-05: 56-NY-92-231. Unpublished study prepared by Zeneca Ag Products. 61 p.
43849913 Storoni, H. (1995) EPTC: Magnitude of the Residue Study on Green Beans after
Treatment with EPTAM 7-E: Lab Proj ect Number: RR 95-049B: EPTC-93-MR-07:
02-CA-93-161. Unpublished study prepared by Zeneca Ag Products. 65 p.
43849914 Storoni, H. (1995) EPTC: Magnitude of the Residue Study on Dry Beans after
Treatment with EPTAM 7-E: Lab Proj ect Number: RR 95-028B: EPTC-93-MR-05:
02-CA-93-141. Unpublished study prepared by Zeneca Ag Products. 57 p.
43849915 Storoni, H. (1995) EPTC: Magnitude of the Residue Study on Dry Beans after
Treatment with EPTAM 7-E Using Chemigation: Lab Proj ect Number: RR 95-043B:
EPTC-93-MR-06: 02-CA-93-151. Unpublished study prepared by Zeneca Ag
Products. 54 p.
133
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43849916 Robbins, J. (1995) EPIC: Processing Study on Cotton from a Trial Conducted in
Arizona During 1992: Lab Project Number: RR95-072B: EPTC-92-PR-01: 14-AZ-
92-251. Unpublished study prepared by Zeneca Ag Products. 89 p.
43849917 Francis, P.; Grant, C. (1995) EPIC: Magnitude of the Residue Study on Cotton after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-045B: EPTC-93-MR-04:
02-CA-93-131. Unpublished study prepared by Zeneca Ag Products. 67 p.
43849918 Roper,E. (1995) EPIC: Processing Study on Tomatoes from aField Trial Conducted
in California During 1993: Lab Project Number: RR95-075B: EPTC-93-PR-02: 02-
CA-93-226. Unpublished study prepared by Zeneca Ag Products. 76 p.
43849919 Roper, E. (1995) EPTC: Magnitude of the Residue Study on Tomatoes after
Treatment with EPTAM 7-E: Lab Project Number: RR 95-071B: EPTC-92-MR-06:
EPTC-93-MR-14. Unpublished study prepared by Zeneca Ag Products. 49 p.
43849920 Grant, C. (1995) Eradicane 6.7-E: Magnitude of the Residue Study on Sweet Corn:
Lab Project Number: RR95-078B: EPTC-93-MR-13: 14-CA-93-221. Unpublished
study prepared by Zeneca Ag Products. 82 p.
43849921 Barnes, J.; Meier, D.; Grant, C. (1995) Eradicane 6.7E: Residue Processing Study
on Field Corn: (Final Report): Lab Project Number: RR 95-068B FIN: EPTC-92-PR-
02: 04-IL-92-311. Unpublished study prepared by Zeneca Ag Products. 174 p.
43849922 Barnes, J.; Curry, K.; Francis, P.; et al. (1995) EPTC: Magnitude of the Residue
Study for Field Corn Forage, Fodder, and Grain after Treatment with Eradicane 6.7-
E: (Final Report): Lab Project Number: RR93-096B FIN: EPTC-92-MR-02: 40-IA-
92-301. Unpublished study prepared by Zeneca Ag Products and Zeneca
Agrochemical. 145 p.
44135301 Francis, P.; Robbins, J.; Storoni, H. (1996) EPTC: Determination of the EPTC
Hydroxy Metabolites and Their Conjugates in Crops by Gas Chromatography: Lab
Project Number: RR 96-089B: 96-089B. Unpublished study prepared by Zeneca Ag
Products. 45 p.
44299601 Bussey, R.; Fomenko, J. (1997) Evaluation of EPTC Through the FDA Multiresidue
Methods: (FinalReport): LabProjectNumber: A030.015:RR97-030B. Unpublished
study prepared by Zeneca Ag Products and Maxim Technologies, Inc. 66 p.
134
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet to
submit certain data as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration of your product(s) containing this
active ingredient(s). Within 90 days after you receive this Notice you must respond as set forth in
Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments 1 through
4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in Attachment 3,
Requirements Status and Registrant's Response Form, (see section III-B); or,
3. why you believe EPA should not require your submission of data in the manner specified by this
Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the registration of your product(s)
subject to this Notice will be subject to suspension. We have provided a list of all of your products
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subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list of all registrants
who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7U.S.C. section 136a(c)(2)(B). Collection of this information
is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107 and 2070-0057
(expiration date 3-31-99).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain specific
chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data
needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of products
containing this active ingredient(s). You have been sent this Notice because you have product(s)
containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements Status and
Registrant's Response Form. Depending on the results of the studies required in this Notice,
additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from 2001L Street, N.W., Washington,
D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3 (cY2VB^ NOTICES ISSUED BY
THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to the Agency
within 90 days after your receipt of this Notice. Failure to adequately respond to this Notice
within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend (NOIS)
affecting your products. This and other bases for issuance of NOIS due to failure to comply with
this Notice are presented in Section IV-A and IV-B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s), (3)
claim generic data exemption, (4) agree to satisfy the data requirements imposed by this Notice
or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option, the Delete
Use(s) option or the Generic Data Exemption option is presented below. A discussion of the
various options available for satisfying the data requirements of this Notice is contained in Section
III-C. A discussion of options relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form (Attachment 2) and the Requirements Status and Registrant's Response Form
(Attachment 3). The Data Call-In Response Form must be submitted as part of every response to
this Notice. Please note that the company's authorized representative is required to sign the first
page of the Data Call-In Response Form and Requirements Status and Registrant's Response
Form (if this form is required) and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the printed material. If you have
questions or need assistance in preparing your response, call or write the contact person identified
in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient(s) that is the subject
of this Notice. If you wish to voluntarily cancel your product, you must submit a completed
Data Call-In Response Form, indicating your election of this option. Voluntary cancellation
is item number 5 on the Data Call-In Response Form. If you choose this option, this is the
only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by eliminating the uses
of your product to which the requirements apply. If you wish to amend your registration to
delete uses, you must submit the Requirements Status and Registrant's Response Form, a
completed application for amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
on the Requirements Status and Registrant's Response Form. You must also complete a Data
Call-In Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and Emergency
Response Branch, Registration Division, at (703) 308-8358.
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If you choose to delete the use(s) subj ect to this Notice or uses subj ect to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for
registration of a product is exempt from the requirement to submit or cite generic data
concerning an active ingredient(s) if the active ingredient(s) in the product is derived
exclusively from purchased, registered pesticide products containing the active ingredient(s).
EPA has concluded, as an exercise of its discretion, that it normally will not suspend the
registration of a product which would qualify and continue to qualify for the generic data
exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must
be met:
a. The active ingredient(s) in your registered product must be present solely
because of incorporation of another registered product which contains the subject
active ingredient(s) and is purchased from a source not connected with you; and,
b. every registrant who is the ultimate source of the active ingredient(s) in your
product subject to this DCI must be in compliance with the requirements of this
Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current "Confidential
Statement of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form. Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-In Response Form. If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for product
specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant(s) who have committed to
generate and submit the required data fail to take appropriate steps to meet the requirements
or are no longer in compliance with this Data Call-In Notice, the Agency will consider that
both they and you are not in compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit
the required data within the specified time. In such cases the Agency generally will not grant
a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various options available
to satisfy the data requirements of this Notice. These options are discussed in Section III-C
of this Notice and comprise options 1 through 6 on the Requirements Status and Registrant's
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Response Form and option 6b and 7 on the Data Call-In Response Form. If you choose
option 6b or 7, you must submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of this Notice
and are covered by options 8 and 9 on the Requirements Status and Registrant's Response
Form. If you choose one of these options, you must submit both forms as well as any other
information/data pertaining to the option chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the data
requirements (i.e. you select option 6b and/or 7), then you must select one of the six options on
the Requirements Status and Registrant's Response Form related to data production for each data
requirement. Your option selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the first six options discussed under
item 9 in the instructions for completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in parentheses to guide registrants
to additional instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame (Developing Data),
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and ungradable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study).
Option 1. Developing Data —
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments.
All data generated and submitted must comply with the Good Laboratory Practice (GLP) rule
(40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG),
and be in conformance with the requirements of PR Notice 86-5. In addition, certain studies
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require Agency approval of test protocols in advance of study initiation. Those studies for
which a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a protocol
which differs from the options discussed in Section II-C of this Notice, you must submit a
detailed description of the proposed protocol and your reason for wishing to use it. The
Agency may choose to reject a protocol not specified in Section II-C. If the Agency rejects
your protocol you will be notified in writing, however, you should be aware that rejection of
a proposed protocol will not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost-share or agreeing to share in the cost of
developing that study. A 90-day progress report must be submitted for all studies. This 90-
day progress report must include the date the study was or will be initiated and, for studies
to be started within 12 months of commitment, the name and address of the laboratory(ies)
or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the
other information specified in the preceding paragraph, at a minimum, a brief description of
current activity on and the status of the study must be included as well as a full description
of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each registrant is subject to receipt
of a Notice of Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirement(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
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Option 2. Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of
the terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development -
If you have made an offer to pay in an attempt to enter into an agreement or amend
an existing agreement to meet the requirements of this Notice and have been unsuccessful,
you may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations,
it will not suspend the registration of a product of a registrant who has in good faith sought
and continues to seek to enter into a joint data development/cost sharing program, but the
other registrant(s) developing the data has refused to accept your offer. To qualify for this
option, you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed
or failing agreement to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of
its election of an option to develop and submit the data required by this Notice by submitting
a Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
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specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify where they
are available. This must be done in accordance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFRPart 160. As stated in 40 CFR 160.3(7) " raw data means
any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted for the
original source as raw data. Raw data may include photographs, microfilm or microfiche
copies, computer printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term "specimens", according to 40 CFR 160.3(7),
means "any material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated Reregi strati on
Phase 3 Technical Guidance and that the study has been conducted according to the
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Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to submit
the study, you must, in addition to certifying that the purposes of the PAG are met by
the study, clearly articulate the rationale why you believe the study meets the purpose
of the PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all
requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you
must identify any action taken by the Agency on the protocol and must indicate, as
part of your certification, the manner in which all Agency comments, concerns, or
issues were addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does
not meet the criteria outlined above but does contain factual information regarding
unreasonable adverse effects, you must notify the Agency of such a study. If such a
study is in the Agency's files, you need only cite it along with the notification. If not
in the Agency's files, you must submit a summary and copies as required by PR Notice
86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and ungradable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
ungradable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are ungradable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied
or corrected and why the study should be rated as acceptable to EPA. Your submission must
also specify the MRID number(s) of the study which you are attempting to upgrade and must
be in conformance with PR Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable or it must be a study which has not
yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status and
Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the
appropriateness of requiring data for low volume, minor use pesticides. In implementing this
provision EPA considers as low volume pesticides only those active ingredient(s) whose total
production volume for all pesticide registrants is small. In determining whether to grant a low
volume, minor use waiver the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the pesticide, and the exposure
and risk from use of the pesticide. If an active ingredient(s) is used for both high volume and
low volume uses, a low volume exemption will not be approved. If all uses of an active
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ingredient(s) are low volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information outlined below. An
exemption will not be granted if any registrant of the active ingredient(s) elects to conduct
the testing. Any registrant receiving a low volume minor use waiver must remain within the
sales figures in their forecast supporting the waiver request in order to remain qualified for
such waiver. If granted a waiver, a registrant will be required, as a condition of the waiver,
to submit annual sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this Notice:
a. Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient(s). If applicable to the active ingredient(s), include
foreign sales for those products that are not registered in this country but are applied
to sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Present the
above information by year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by year for each
of the past five years.
c. Total direct production cost of product(s) containing the active ingredient(s)
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient(s) by year for the
past five years. Exclude all non-recurring costs that were directly related to the active
ingredient(s), such as costs of initial registration and any data development.
e. A list of each data requirement for which you seek a waiver. Indicate the type
of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
f A list of each data requirement for which you are not seeking any waiver and
the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient(s), direct production costs of product(s)
containing the active ingredient(s) (following the parameters in item c above), indirect
production costs of product(s) containing the active ingredient(s) (following the
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parameters in item d above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active ingredient(s)
to users. Discuss the use patterns and the effectiveness of the active ingredient(s)
relative to registered alternative chemicals and non-chemical control strategies. Focus
on benefits unique to the active ingredient(s), providing information that is as
quantitative as possible. If you do not have quantitative data upon which to base your
estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient(s) in terms
of its benefits, you should provide information on any of the following factors, as
applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s) in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient(s), as opposed to its registered
alternatives, (c) information on the breakdown of the active ingredient(s) after use and
on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination regarding a
request for a low volume minor use waiver will result in denial of the request for a waiver.
2. Request for Waiver of Data -Option 9 on the Requirements Status and Registrant's
Response Form. This option may be used if you believe that a particular data requirement
should not apply because the corresponding use is no longer registered or the requirement is
inappropriate. You must submit a rationale explaining why you believe the data requirements
should not apply. You must also submit the current label(s) of your product(s) and, if a
current copy of your Confidential Statement of Formula is not already on file you must submit
a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice do not apply to your product(s), you will not be
required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data
are required for your productfsl you must choose a method of meeting the requirements of
this Notice within the time frame provided by this Notice. Within 30 days of your receipt of
the Agency's written decision, you must submit a revised Requirements Status and
Registrant's Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
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The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer, or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form: or,
b. fulfill the commitment to develop and submit the data as required by this
Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the specified
time frame.
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9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines,
Data Reporting Guidelines, and Gene Tox Health Effects Test Guidelines) regarding the
design, conduct, and reporting of required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures, selection of species, number of
animals, sex and distribution of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Federal Insecticide, Fungicide, and Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
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If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient(s) for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the Agency granting any additional time to sell, distribute, or use existing
stocks beyond a year from the date the 90 day response was due unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel your registration six months
before a 3 year study is scheduled to be submitted, all progress reports and other information
necessary to establish that you have been conducting the study in an acceptable and good faith
manner must have been submitted to the Agency, before EPA will consider granting an existing
stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide is
registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this Notice,
call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the Data
Call-In Response Form need be submitted.
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The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance (OECA),
EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
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1. EPTC Data Call-In Chemical Status Sheet
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
EPTC.
This Generic Data Call-In Chemical Status Sheet, contain an overview of data required by this
notice, and point of contact for inquires pertaining to the reregi strati on of EPTC. This attachment
is to be used in conjunction with (1) the Generic data Call-In Notice, (2) the Generic Data Call-
in Response From (Attachment 2), (3) the Requirement Status and Registration's Form (Attachment
2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), and (6) the Cost Share and Data Compensation Forms in replying to this EPTC
Generic Data Call In (Attachment F). Instruction and guidance accompany each form.
DATA REQUIREMENT BY THIS NOTICE
The additional data requirement needed to complete the generic database for EPTC are contained
in the Requirements Status and Registrant's Response. Attachment C. The Agency has concluded
that additional product chemistry data on EPTC are needed. These data are needed to fully
complete the registration of all eligible EPTC products.
INQUIRIES AND RESPONSE TO THIS NOTICE
If you have any question regarding the generic data requirements and procedures established by
this Notice, please contact Jamil Mixon at (703) 308-8032.
All response to this Notice for the generic data requirements should be submitted to:
Jamil Mixon, Chemical Review Manager
Special Review and Registration Division (7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: EPTC
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific data for
the purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide Act.
Fill out this form each time you are responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by the
registrant as appropriate Items 8 through 11 must be completed by the registrant before submitting
a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U S
Environmental Protection Agency, 401 M St, S W , Washington, D C 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number and chemical
name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data call-in. Please
note that you are also responsible for informing the Agency of your response
regarding any product that you believe may be covered by this data call-in but that is
not listed by the Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel voluntarily. If a
registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. You do not need
to complete any item on the Requirements Status and Registrant's Response Form for
any product that is voluntarily cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item 3 and if you
are eligible for a Generic Data Exemption for the chemical listed in Item 2 and used
in the subject product. By electing this exemption, you agree to the terms and
conditions of a Generic Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration
Number of each registered source of that active ingredient that you use in your
product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with this
and-any other outstanding Data Call-In Notice), and incorporate that product into all
your products, you may complete this item for all products listed on this form If,
however, you produce the active ingredient yourself, or use any unregistered product
(regardless of the fact that some of your sources are registered), you may not claim
a Generic Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in Item 3 and
if you are agreeing to satisfy the generic data requirements of this data call-in. Attach
the Requirements Status and Registrant's Response Form that indicates how you will
satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a manufacturing
use product (MUP), and if your product is a manufacturing use product for which you
agree to supply product-specific data. Attach the Requirements Status and
Registrants' Response Form that indicates how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP) as
indicated in Item 3 and if your product is an end use product for which you agree to
supply product-specific data. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an authorized representative of your
company and the person signing must include his/her title. Additional pages used in
your response must be initialed and dated in the space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding your
response.
Item 11. Enter the phone number of your company contact.
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DATA CALL-IN RESPONSE TABLE Page l of l
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND REGISTRANTS RESPONSE
FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and product-specific
data as part of EPA's reregi strati on program under the Federal Insecticide Fungicide and Rodenticide
Act. Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use waiver.
These instructions are for completion of generic data requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and has
preprinted this form with a number of items. DO NOT use this form for any other active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and chemical name.
Item 3.This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support the
product(s) being reregistered. These guidelines, in addition to requirements specified in the
Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number and whether
protocols and 1, 2, or 3-year progress reports are required to be submitted in connection with
the study. As noted in Section III of the Data Call-In Notice, 90-day progress reports are
required for all studies.
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If an asterisk appears in Item 5, EPA has attached information relevant to this guideline
reference number to the Requirements Status and Registrant's Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A brief
description of each code follows:
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 crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for testing. A brief
description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
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TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical End-Use
Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol identified
in item 2. The time frame runs from the date of your receipt of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply with each
data requirement. Brief descriptions of each code follow. The Data Call-In Notice contains
a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time frames
specified in item 8 above. By indicating that I have chosen this option, I certify that
I will comply with all the requirements pertaining to the conditions for Submittal of
this study as outlined in the Data Call-In Notice and that I will provide the protocol
and progress reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or more
registrants to develop data jointly. By indicating that I have chosen this option, I
certify that I will comply with all the requirements pertaining to sharing in the cost of
developing data as outlined in the Data Call-In Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with one or
more registrants to develop data jointly. I am submitting a copy of the form
"Certification of Offer to Cost Share in the Development of Data" that describes this
offer/agreement. By indicating that I have chosen this option, I certify that I will
comply with all the requirements pertaining to making an offer to share in the cost of
developing data as outlined in the Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has never before
been submitted to EPA. By indicating that I have chosen this option, I certify that this
study meets all the requirements pertaining to the conditions for Submittal of existing
data outlined in the Data Call-In Notice and I have attached the needed supporting
information along with this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that EPA has
classified as partially acceptable and potentially ungradable. By indicating that I have
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chosen this option, I certify that I have met all the requirements pertaining to the
conditions for submitting or citing existing data to upgrade a study described in the
Data Call-In Notice. I am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I am citing as
well as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously classified by
EPA as acceptable, core, core minimum, or a study that has not yet been reviewed by
the Agency. I am providing the Agency's classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements concerning low
volume-minor use data waivers in the Data Call-In Notice and I request a low-volume
minor use waiver of the data requirement. I am attaching a detailed justification to
support this waiver request including, among other things, all information required to
support the request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data waivers
other than low volume minor-use data waivers in the Data Call-In Notice and I
request a waiver of the data requirement. I am attaching an identification of the basis
for this waiver and a detailed justification to support this waiver request. The
justification includes, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages of
this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Requirements Status And Registrants Responsecinsert Requirements
Status and registrants response here 1 of 2
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Requirements Status And Registrants Responsecinsert Requirements status and
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VT - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION! WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
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The product specific data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required in this
Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development (OECD)
are also acceptable if the OECD-recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD protocols, they
should be modified as appropriate so that the data generated by the study will satisfy the requirements
of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED BY THE
AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(sX or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION IE. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
HI-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must be
submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to
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Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to
comply with this Notice are presented in Section IV-A and IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or (c)
request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A discussion of options relating to requests
for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response, one
or both must be used in your response to the Agency. These forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and Attachment 3.
The Data Call-In Response Form must be submitted as part of every response to this Notice. In
addition, one copy of the Requirements Status and Registrant's Response Form must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation option is
selected or unless the product is identical to another (refer to the instructions for completing the Data
Call-In Response Form in Attachment 2). Please note that the company's authorized representative is
required to sign the first page of the Data Call-In Response Form and Requirements Status and
Registrant's Response Form (if this form is required) and initial any subsequent pages. The forms
contain separate detailed instructions on the response options. Do not alter the printed material. If
you have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5 on
the Data Call-In Response Form. If you choose this option, this is the only form that you are required
to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions of
this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various options
available to satisfy the product specific data requirements of this Notice. These options are discussed
in Section III-C of this Notice and comprise options 1 through 6 on the Requirements Status and
Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response Form.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling product
specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are discussed
in Section III-D of this Notice and are covered by option 7 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms as well
as any other information/data pertaining to the option chosen to address the data requirement.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the six
options on the Requirements Status and Registrant's Response Form related to data production for
each data requirement. Your option selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the first six options discussed under item 9
in the instructions for completing the Requirements Status and Registrant's Response Form. These
six options are listed immediately below with information in parentheses to guide registrants to
additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and ungradable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and in
the attachments. All data generated and submitted must comply with the Good Laboratory Practice
(GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines
(PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not submitted
by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the affected
registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing the
testing. While EPA is considering your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your request, the original deadline remains.
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Normally, extensions can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting the 90-day
responses. Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after the lapse of
the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the group. The
registration number of the product for which data will be submitted must be noted in the agreement to
cost share by the registrant selecting this option. If you choose to enter into an agreement to share in
the cost of producing the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be submitting the data. You must also provide EPA with
documentary evidence that an agreement has been formed. Such evidence may be your letter offering
to join in an agreement and the other registrant's acceptance of your offer, or a written statement by
the parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms. Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development ~ This option only applies to acute
toxicity and certain efficacy data as described in option 2 above. If you have made an offer to pay in
an attempt to enter into an agreement or amend an existing agreement to meet the requirements of this
Notice and have been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with the data submission
requirements of this Notice. EPA has determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product of a registrant who has in good faith
sought and continues to seek to enter into a joint data development/cost sharing program, but the
other registrant(s) developing the data has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another registrant
(who has an obligation to submit data) to share in the burden of developing that data. You must also
submit to the Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment 7. In addition, you must demonstrate that the other registrant to
whom the offer was made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that offer (such as a
certified mail receipt). Your offer must, in addition to anything else, an offer to share in the burden of
producing the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must
also inform EPA of its election of an option to develop and submit the data required by this Notice by
submitting a Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails to
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develop the data or for some other reason is subject to suspension, your registration as well as that of
the other registrant will normally be subject to initiation of suspension proceedings, unless you
commit to submit, and do submit the required data in the specified time frame. In such cases, the
Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to be
repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFRPart 160. As stated in 40 CFR
160.3(j)" 'raw data' means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and activities of a
study and are necessary for the reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data have been prepared (e.g., tapes
which have been transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original source as raw data.
'Raw data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40 CFR 160.3(k), means
"any material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
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for consideration if the registrant believes that the study clearly meets the purpose of
the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition
to certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of the
criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in the Agency's files, you need only cite
it along with the notification. If not in the Agency's files, you must submit a summary and copies as
required by PR Notice 86-5.
Option 5. Upgrading a Study ~ If a study has been classified as partially acceptable and
ungradable, you may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the requirement is not satisfied,
you may still be required to submit new data normally without any time extension. Deficient, but
ungradable studies will normally be classified as supplemental. However, it is important to note that
not all studies classified as supplemental are ungradable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the contact person listed in
Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply information
to correct all deficiencies in the study identified by EPA. You must provide a clearly articulated
rationale of how the deficiencies have been remedied or corrected and why the study should be rated
as acceptable to EPA. Your submission must also specify the MRID number(s) of the study which
you are attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade a
study, but has not yet been reviewed by the Agency. You must provide the MRID number of the data
submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all data
submissions intended to upgrade studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with each of those criteria as well as a
certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies ~ If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable toxicology studies generally will
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have been classified as "core-guideline" or "core minimum." For all other disciplines the
classification would be "acceptable." With respect to any studies for which you wish to select this
option you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements described
in the instructions for completing the Data Call-In Response Form and the Requirements Status and
Registrant's Response Form, as appropriate.
HI-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data
must be submitted in the format required by PR Notice 86-5). This will be the only opportunity to
state the reasons or provide information in support of your request. If the Agency approves your
waiver request, you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data requirements
of this Notice within 30 days of the receipt of the Agency's decision. You must indicate and submit
the option chosen on the Requirements Status and Registrant's Response Form. Product specific data
requirements for product chemistry, acute toxicity and efficacy (where appropriate) are required for
all products and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the due date for
the study in question. Waiver requests submitted without adequate supporting rationale will be
denied and the original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to FIFRA
section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to Suspend
include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and Gene Tox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to test material, test procedures, selection of species, number of animals, sex and distribution
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of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks of
a pesticide product which has been suspended or cancelled if doing so would be consistent with the
purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of clearly
demonstrating to EPA that granting such permission would be consistent with the Act. You must also
explain why an "existing stocks" provision is necessary, including a statement of the quantity of
existing stocks and your estimate of the time required for their sale, distribution, and use. Unless you
meet this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and your
product is in full compliance with all Agency requirements, you will have, under most circumstances,
one year from the date your 90 day response to this Notice is due, to sell, distribute, or use existing
stocks. Normally, the Agency will allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use such existing stocks until the stocks are
exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products containing an
active ingredient for which the Agency has particular risk concerns will be determined on case-by-
case basis.
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Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the Agency granting any additional time to sell, distribute, or use existing
stocks beyond a year from the date the 90 day response was due unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements of
this Notice. For example, if you decide to voluntarily cancel your registration six months before a 3
year study is scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner must have
been submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data exemption
option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (oc) of the Office of Pesticides and Toxic Substances
(OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of Formula
Form
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EPTC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing EPTC.
This Product Specific Data Call-In Chemical Status Sheet contain an overview of data required
by this notice, and point of contact for inquires pertaining to the reregi strati on of EPTC. This
attachment is to be used in conjunction with (1) the Products Data Call-In Notice, (2) the Products
Specific Data Call-In Response From (Attachment 2), (3) the Requirement Status and Registration's
Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) a list of
registrants receiving this DCI ( Attachment 6) and (7) the Cost Share and Data
Compensation Forms in replying to this EPTC Product Specific Data Call-In (Attachment 7)
Instructions and guidance accompany each form.
DATA REQUIREMENT BY THIS NOTICE
The additional data requirement needed to complete the generic database for EPTC are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on EPTC are needed for specific product. These data are needed
to fully complete the registration of all eligible EPTC products.
INQUIRIES AND RESPONSE TO THIS NOTICE
If you have any question regarding the generic data requirements and procedures established by
this Notice, please contact Venus Eagle-Kunst at (703) 308-8045.
All response to this Notice for the generic data requirements should be submitted to:
Chemical Review Manager
Product Registration Branch
Special Review and Registration Branch (7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: EPTC
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this option, you will
not have to provide the data required by the Data Call-In Notice and you will not have to
complete any other forms. Further sale and distribution of your product after the effective date
of cancellation must be in accordance with the Existing Stocks provision of the Data Call-In
Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your product is
identical to another product and you qualify for a data exemption, you must respond with "yes"
to Item 7a (MUP) or 7B (EUP) on this form, provide the EPA registration numbers of your
source(s); you would not complete the "Requirements Status and Registrant's Response" form.
Examples of such products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you must
agree to satisfy the data requirements by responding "yes." If you are requesting a data
waiver, answer "yes" here; in addition, on the "Requirements Status and Registrant's
Response" form under Item 9, you must respond with Option 7 (Waiver Request) for
each study for which you are requesting a waiver. See Item 6 with regard to identical
products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily
canceled this product. For these cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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DATA CALL-IN RESPONSE Table # 2 page 2 of 2
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND REGISTRANT'S
RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1 -3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3. This
number must be used in the transmittal document for any data submissions in response
to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's continued
registration are identified. These guidelines, in addition to the requirements specified in the
Notice, govern the conduct of the required studies. Note that series 61 and 62 in product
chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is (are)
identified. For most product specific data requirements, all use patterns are covered by the data
requirements. In the case of efficacy data, the required studies only pertain to products which
have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the product as
formulated for sale and distribution is the test substance, except in rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8 months after
issuance of the Reregi strati on Eligibility Document unless EPA determines that a longer time
period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show how you
intend to comply with the data requirements listed in this table. Fuller descriptions of each
option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for Submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA Form
8570-29) and (2) two completed and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this option
is available only for acute toxicity or certain efficacy data and only if EPA indicates in an
attachment to this Notice that my product is similar enough to another product to qualify
for this option. I certify that another party in the agreement is committing to submit or
provide the required data; if the required study is not submitted on time, my product may
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be subject to suspension. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA Form
8570-29) and (2) two completed and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data and
only if EPA indicates in an attachment to this Data Call-In Notice that my product is
similar enough to another product to qualify for this option. I am submitting evidence
that I have made an offer to another registrant (who has an obligation to submit data) to
share in the cost of that data. I am also submitting a completed "Certification of Offer
to Cost Share in the Development Data" form. I am including a copy of my offer and
proof of the other registrant's receipt of that offer. I am identifying the party which is
committing to submit or provide the required data; if the required study is not submitted
on time, my product may be subject to suspension. I understand that other terms under
Option 3 in the Data Call-In Notice (Section III-C. 1.) apply as well. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed and
signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that this
study will meet all the requirements for Submittal of existing data outlined in Option 4
in the Data Call-In Notice (Section III-C. 1.) and will meet the attached acceptance
criteria (for acute toxicity and product chemistry data). I will attach the needed
supporting information along with this response. I also certify that I have determined
that this study will fill the data requirement for which I have indicated this choice. By
the specified due date, I will also submit a completed "Certification With Respect To
Data Compensation Requirements" form (EPA Form 8570-29) to show what data
compensation option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by the
Agency as partially acceptable and ungradable (Upgrading a Study). I will submit
evidence of the Agency's review indicating that the study may be upgraded and what
information is required to do so. I will provide the MRID or Accession number of the
study at the due date. I understand that the conditions for this option outlined Option
5 in the Data Call-In Notice (Section III-C. 1.) apply. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies of
the Confidential Statement of Formula (EPA Form 8570-4).
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6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study). If I am citing another registrant's study, I understand that this
option is available only for acute toxicity or certain efficacy data and only if the cited
study was conducted on my product, an identical product or a product which EPA has
"grouped" with one or more other products for purposes of depending on the same data.
I may also choose this option if I am citing my own data. In either case, I will provide
the MRID or Accession number(s) for the cited data on a "Product Specific Data
Report" form or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format required by P.R. Notice 86-5].
I understand that this is my only opportunity to state the reasons or provide information
in support of my request. If the Agency approves my waiver request, I will not be
required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency
denies my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30 days of
my receipt of the Agency's written decision, submit a revised "Requirements Status and
Registrant's Response" Form indicating the option chosen. I also understand that the
deadline for submission of data as specified by the original data call-in notice will not change.
By the specified due date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily
canceled this product. For these cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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Requirements Status And Registrant's Response Page 1 of 5
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Requirements Status And Registrant's Response Page 2 of 5
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDANCE REQUIREMENTS Page 3 of 5
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDANCE REQUIREMENTS Page 4 of 5
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4. EPA'S Batching of EPTC Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregi strati on of products containing EPTC 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. Not with-standing the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA
to be similar for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data
is referenced, registrants must clearly identify the test material by EPA Registration Number. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she
must select one of the following options: Developing Data (Option 1), Submitting an Existing Study
(Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or 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.
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Thirteen products were found which contain EPTC as the active ingredient. These products have
been placed into two batches and a "no batch" category in accordance with the active and inert
ingredients and type of formulation.
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.
10182-220
10182-223*
10182-226
19713-101
34704-701
% Active Ingredient
EPTC. ..87.8%
EPTC... 82. 6%
EPTC.. .87.8%
EPTC... 87.27%
EPTC.. .87.8%
Formulation Type
liquid
liquid
liquid
liquid
liquid
Batch
2
EPA Reg. No.
4-156
192-187
769-872
829-225
10182-172
% Active Ingredient
EPTC. ..2. 3%
EPTC.. .2.3%
EPTC. ..2. 3%
EPTC.. .2.3%
EPTC. ..2. 3%
Formulation Type
solid
solid
solid
solid
solid
No Batch
EPA Reg. No.
10182-199
10182-217
10182-388
% Active Ingredient
EPTC. ..20%
EPTC.. .98.5%
EPTC. ..67.8%
Formulation Type
solid
liquid
liquid
*A product specific eye irritation study for 10182-223 is required.
Products in Batch 2 may cite 10182-199.
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5. List of All registrants sent this Data call-In
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Insert List-Page 1 of 1
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Appendix F. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/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 hardtop in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.
http://www.epa.gov/opprd001/forms/8570-17.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
http://www.epa.gov/opprd001/forms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
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8570-36
8570-37
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/opppmsdl/PR Notices/pr98-l .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/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
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e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program
resulting from the passage of the FQPA and the reorganization of the Office of Pesticide
Programs. We anticipate that this publication will become available during the Fall of
1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge
a fee for subscriptions and custom searches. You can contact NPIRS by telephone at
(765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTNby telephone at (800) 858-7378 orthrough their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for the
new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or tolerance
petition.
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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.
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Documents Associated with this RED
Precautionary Statements: Hazards to Humans and Domestic Animals
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
a. Health and Environmental Effects Science Chapters.
b. Detailed Label Usage Information System (LUIS) Report.
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