United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA738-R-97-011
January 1998
Reregistration
Eligibility Decision (RED)
TERBACIL
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-R-97-O11
January 1998
R.E.D. FACTS
Terbacil
Pesticide All pesticides sold or distributed in the United States must be regis-
Reregistration tered 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 provi-
sions of the Food Quality Protection Act of 1996, EPA considers the special
sensitivity of infants and children to pesticides, as well as aggregate expo-
sure 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 safely standard of the FQPA and can be
used without posing unreasonable risks to human health or the environ-
ment.
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 0039, Terbacil.
Use Profile
Terbacil is a selective herbicide used to control broadleaf weeds on
terrestrial food/feed crops (e.g., apples, mint/peppermint/spearmint,
sugarcane, and.ornamentals), forestry [e.g., cottonwood
(forest/shelterbelt)], terrestrial food (e.g., asparagus, blackberry, boysen-
berry, dewberry, loganberry, peach, raspberry, youngberry and straw-
berry), and terrestrial feed (e.g.,.alfalfa, sainfoin (hay and fodder), and
forage).
Formulations include a wettable powder and products are applied by
aircraft or ground equipment including boom sprayers.
Use practice limitations include prohibition of applications through
any type of irrigation system. They also prohibit grazing treated crops or
allowing hay, seeds or seed screening from treated crops to be used for food
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or feed. Grazing or feeding forage or hay from treated areas to livestock is
prohibited.
Regulatory
History
Human Health
Assessment
Terbacil was first registered for use as a herbicide in the U.S. in
1966. EPA issued a Registration Standard for terbacil in May 1982. In
August 1989 a Registration Standard (Second Round Review) was issue for
terbacil. This document reviewed data submitted in response to the 1982
Registration Standard, updated the Agency's assessment of the terbacil data
base, and included a tolerance reassessment. The Second Round Review
required additional data in the area of toxicology, environmental fate,
ecological effects, and residue chemistry. On August 3, 1996, the Food
Quality Protection Act of 1996 (FQPA) was signed into law. FQPA amends
both the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FQPA amend-
ments went into effect immediately and were considered during this
reregistration decision. Currently, there are 5 active terbacil products
registered.
Toxicity
In studies using laboratory animals, terbacil is slightly toxic by the
oral and dermal routes and has been placed in Toxicity Category IV (the
lowest of four categories) for these effects. For the inhalation route, the
Toxicity Category is III. Terbacil per se is mildly irritating to the eyes
(Toxicity Category III).
In a chronic feeding study using beagle dogs, terbacil caused increased
thyroid to body weight ratios, slight increase hi liver weights, and elevated
alkaline phosphatase levels.
Terbacil.has been evaluated for potential carcinogenic activity hi mice
and rats. Terbacil did not induce any increase hi tumor incidence in the
treated animals. Terbacil is classified hi Group E (no evidence of carcino-
genicity in animals studies) with respect to its cancer potential.
Terbacil demonstrates some evidence of causing developmental
toxicity effects in rats and rabbits. These effects are likely due to maternal
toxicity from exposure to bromacil rather than from specific developmental
toxicity of terbacil. Therefore, the Agency does not consider terbacil a
developmental toxicant.
Dietary Exposure
People may be exposed to residues of terbacil through the diet.
Generally, acute dietary margins of exposure greater than 100 tend to cause
no dietary concern. Because the endpoint of concern was a developmental
effect, the only sub-population of concern is females of child bearing age
(i.e., females, 13+years old). Presently registered commodities result hi an
MOE for females (13+ years) of 3125, which demonstrates that there is no
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cause for concern regarding acute dietary exposure from terbacil for both
existing and proposed uses.
In assessing chronic dietary risk from food, EPA estimates that
terbacil residues in food account for 12.2% of the RfD, based on existing
tolerances and assuming 100% of the crop treated. 'Incorporating the results
of the Agency's reregistration review (i.e., recommendationns to revoke
tolerances for citrus fruits and pears, and to raise tolerances on caneberries,
blueberries, peaches, apples, and sugarcane), 4.5% of the RfD is utilized.
No Codex Maximum Residue Limits (MRLs) have been established
for terbacil for any agricultural commodity. Therefore, no compatibility
questions exist with respect to U.S. tolerances. '
Occupational Exposure
An occupational exposure assessment is required for an active ingredi-
ent if (I)'certain lexicological criteria are triggered and (2) there is potential
exposure to handlers (mixers, loaders, applicators, etc.) during use or to
persons-entering treated sites after application is complete. The Toxicity
Endpoint Selection Committee found that neither dermal nor inhalation
toxicity criteria were triggered for terbacil. Therefore, no assessments are
needed for occupational exposure/risk at this time.
Human Risk Assessment
EPA conducted additional risk analyses using available data in re-
sponse to the new FQPA requirements. Based on current data require-
ments, terbacil has a complete database for developmental and reproductive
toxicity. Because the developmental NOELs were the same as those for
maternal toxiciry, arid the NOEL for systemic (parental) toxiciry was higher
than the NOEL for reproductive toxicity, these data do not suggest increased
pre- or post-natal sensitivity of children and infants to terbacil exposure.
Therefore, EPA concludes that the available toxicology data do not support
an uncertainty factor of 1000 as specified in FQPA and that the present
uncertainty factor of 100 is adequate to ensure the protection of infants and
children from exposure to terbacil. EPA estimates that terbacil residues in
the diet of infants and children account for 12.8% of the RfD and residues
in drinking water account for 81 % of the RfD. Therefore, the Agency
concludes that aggregate risks for infants and children resulting from
terbacil uses are not of concern.
In assessing aggregate risk dietary, exposure from food and drinking
water were considered. Aggregate acute dietary risk for females of child-
bearing age was calculated and the MOE= 1563. Acute dietary risk from
food alone was calculated for females of child-bearing age and the
MOE=4166 (based on tolerance levels reassessed in this RED and 100%
crop treated). In assessing aggregate chronic dietary risk, exposures from
food and drinking water were considered. The aggregate exposures account
for 27.6% of the RfD. Aggregate exposure/risk values are all below the
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level of Agency concern. This includes the acute exposure of females of
child-bearing age.
In evaluating the potential for cumulative effects, EPA compared
terbacil with other structurally similar substituted uracil compounds, such as
bromacil and lentacil, and then with other compounds producing similar
effects. A comparison of the available toxicological database for terbacil
and bromacil revealed no clear common mode of toxicity for the chemicals.
The toxicology database for lentacil was not considered because there are
currently no registered uses of lentacil. Based on the available data, the
Agency has determined that there is no clear common mode of toxicity
between terbacil and bromacil.
Environmental Ecological Effects Risk Assessment
Assessment Minimal adverse acute effects are expected for avian, mammalian, and
aquatic species from labeled uses of terbacil. Chronic effects for avian and
aquatic species cannot be evaluated at this time because of insufficient data.
However, chronic risk quotients (RQs) for mammals indicate that adverse
effects are possible from labeled uses of terbacil. There is some uncer-
tainty in assessing adverse chronic mammalian effects because the NOEL is
greater than the maximum concentration tested in rat reproduction study
design. Therefore, the highest concentration is a default toxicity endpoint
which is a conservative estimate of risk. Since terbacil is a persistent and
mobile herbicide, non-target terrestrial plants are expected to be adversely
affected from runoff and spray drift. Minimal adverse effects, however,
are expected for non-target aquatic plants. Because terbacil is used exclu-
sively on minor crops, terbacil exposure is expected to be very localized and
dependent on site specific conditions. The localized nature of terbacil use
areas is expected to limit human and ecological exposure.
Risk Mitigation To lessen the risks posed by terbacil, EPA is requiring the following
risk mitigation measures.
° Maximum label application rates should be reduced to be
representative of typical application rates.
o The Agency recommends a surface water label advisory on terbacil
because it has characteristics (persistent and very mobile) of pesticides
found in surface waters. Surface water modeling for a
Louisiana sugarcane scenario indicates terbacil may accumulate at
concentrations greater than 1 mg/L. Since terbacil is used on
vulnerable soils for surface water contamination such as the Louisiana
production area, a surface water label advisory is recommended. The
label advisory should state: "Terbacil has properties that may result in
surface water contamination via dissolved runoff and runoff erosion.
Practices should be followed to minimize the potential for dissolved
runoff and runoff and/or runoff erosion."
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Additional Data
Required
° Terbacil is more mobile and persistent than a number of herbicides
which have been found to contaminate ground water. EPA has
recommended a ground water label advisory since 1989, and continues
to recommend this. The following label language is appropriate:
"This chemical has properties and characteristics associated with chemicals
detected in ground water. The use of this chemical in areas where soils are
permeable, particularly where the water table is shallow, may result in
ground water contamination. " •
EPA is requiring the following additional generic studies for terbacil
to confirm its regulatory assessments and conclusions:
• Avian Reproduction Quail [71-4(a>]
• Avian Reproduction Duck [71-4(b)]
• Early Life-Stage Fish [72-4(a>]
• Life-Cycle Aquatic Invertebrate [72-4(b>]
• Aerobic Aquatic Metabolism [162-4]
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential .Statements of
Formula (CSFs), and revised labeling for reregistration.
Product Labeling All terbacil end-use products must comply with EPA's current pesti-
Changes Required cide product labeling requirements and with the following. For a compre-
hensive list of labeling requirements, please see the terbacil RED document,
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain terbacil, the
product labeling must be revised to adopt the handler personal protective
equipment requirements set forth in this section. Any conflicting PPE
. requirements on the current labeling must be removed;
For multiple-active-ingredient end-use products that contain terbacil,
the handler perspnal protective equipment requirements set forth in this
section must be compared to the requirements on the current labeling and
the more protective must be retained. For guidance on which requirements
are considered more protective, see PR Notice 93-7.
Minimum PPE/Engineering Control Requirements
EPA is not establishing active ingredient-specific PPE or engineering
control requirements for terbacil end-use products.
Actual end-use product PPE requirements
Any necessary PPE for each terbacil occupational end-use product will
be established on the basis of the end-use product's acute toxicity category.
Placement in labeling
The personal protective equipment must be placed on the end-use
, " product labeling in the location specified in PR Notice 93-7 and the format
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and language of the PPE requirements must be the same as is specified in
PR Notice 93-7.
Entry Restrictions
For sole-active-ingredient end-use products that contain terbacil the
product labeling must be revised to adopt the entry restrictions set forth in
this section. Any conflicting entry restrictions on the current labeling must
be removed.
For multiple-active-ingredient end-use products that contain terbacil
the entry restrictions set forth in this section must be compared to the entry
restrictions on the current labeling and the more protective must be retained.
A specific time-period hi hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
Restricted-entry interval
A 12-hour restricted-entry interval (REI) is required for uses within
the scope of the WPS on all terbacil end-use products!
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain terbacil, the
product labeling must be revised to adopt the handler personal protective
equipment requirements set forth in this section. Any conflicting PPE
requirements on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain terbacil,
the handler personal protective equipment requirements set forth in this
section must be compared to the requirements on the current labeling and
the more protective must be retained. For guidance on which requirements
are considered more protective, see PR Notice 93-7.
Minimum PPE/Engineering Control Requirements
EPA is not establishing active ingredient-specific PPE or engineering
control requirements for terbacil end-use products.
Actual end-use product PPE requirements
Any necessary PPE for each terbacil occupational end-use product will
be established on the basis of the end-use product's acute toxicity category.
Placement in labeling
The personal protective equipment must be placed on the end-use
product labeling in the location specified in PR Notice 93-7 and the format
and language of the PPE requirements must be the same as is specified in
PR Notice 93-7.
Entry Restrictions
For sole-active-ingredient end-use products that contain terbacil the
product labeling must be revised to adopt the entry restrictions set forth in
this section. Any conflicting entry restrictions on the current labeling must
be removed.
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Regulatory
Conclusion
For More
information
For multiple-active-ingredient end-use products that contain terbacil
the entry restrictions set forth in this section must be compared to the entry
restrictions on the current labeling and the more protective must be retained.
A specific time-period in hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
Restricted-entry interval
A 12-hour restricted-entry interval (REI) is required for uses within
the scope of the WPS on all terbacil end-use products.
The use of currently registered products containing terbacil in accor-
dance 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.
Terbacil products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for terbacil during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Information and Records Integrity
Branch, Information Resources and Services (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 Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-
800-490-9198; fax 513-489-8695.
Following the comment period, the terbacil RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the terbacil RED, or reregistration of individual products containing
terbacil, please contact the Special Review and Reregistration Division
(7508W), 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 Time, or 9:30 am to
7:30 pm Eastern Standard Time, seven days a week.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
SEP 3 0 1997
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case terbacil, which
includes the active ingredient (3-tert-butyl-5-ehloro-6-methyl uracil). The enclosed
Reregistration Eligibility Decision (RED) 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 also includes requirements for additional data (generic) on the
active ingredients 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
receipt 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 the 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
also 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 rule-making that may be required.
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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.
If you have questions on the product specific data requirements or wish to, meet with
the Agency, please contact the Special Review and Reregistration Division representative
Karen Jones (703) 308-8047. Address any questions on required generic data to the Special
Review and Reregistration Division representative Emily Mitchell (703) 308-8583.
Sincerely yours,
Enclosures
1 Lois A. Rossi, Director
Special Review and
Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN rDCD OR "90-DAY RESPONSE"-If generic data ar
reregistration, 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-Nn 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"-Yn« must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistratinn (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 reregistration) 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-
487-4650).
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).
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REREGISTRATION ELIGIBILITY DECISION
TERBACIL
LIST A
CASE0039
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
TERBACIL REREGKTRATION ELIGIBILITY DECISION TEAM .... i
I. INTRODUCTION . ......... .....,;..,.... 1
H. CASE OVERVIEW 2
A. Chemical Overview . . . . . ........... 2
1. UseProffie , . . , . 2
2. Estimated Usage of Pesticide 3
(1) Data Requirements . ; 4
3. Regulatory History 5
m. SCIENCE ASSESSMENT .5
A. Physical Chemistry Assessment . . ."...' 5
1. Description of Chemical ...... 5
a. Identification of the Active Ingredient 5
(1) Manufacturing-use Products , . 5
.(2) Regulatory Background 6
(3) Conclusions for Product Chemistry ............ 6
B, Human Health Assessment . ; ......... 6
1. Hazard Assessment 6
a. Acute Toxicity . . 6
b. Subchronic Toxicity . ; . 7
c. Chronic toxicity 7
d. Carcinogenicity . 9
e. Developmental Toxicity 9
f. Reproductive Toxicity . 10
g. Mutagenicity ." 10
h. Metabolism . \\
2. Toxicological Endpoint of Concern Used in Risk Assessment ... 11
a. Reference Dose ; 11
b. Carcinogenicity Classification 11
c., Other Toxicological Endpoints .:•. .... 11
(1) Acute Dietary ..;................ 12
(2) Dermal Absorption ......... ... . . 12
(3) Short and Intermediate Term Occupational 13
(4) Chronic Occupational (Non-Cancer) 13
3. Exposure Assessment 13
a. Dietary Exposure (Food Sources) 13
(1) Directions for Use . . . ..................' 14
(2) Nature of the Residue in Plants . 15
(3) Nature of the Residue in Livestock 15
(4) Residue Analytical Methods 15
(5) Multi-residue Method Testing ; ... 16
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(6) Storage Stability Data 17
(7) Magnitude of the Residue in Crop Plants 17
(8) Magnitude of the Residue in Processed Food/Feed
17
(9) Magnitude of the Residue in Meat, Milk, Poultry, and
Eggs 18
(10) Magnitude of the Residue in Water, Fish, and
Irrigated Crops 18
(11) Magnitude of the Residue in Food-Handling
Establishments . . 18
(12) Confined Accumulation in Rotational Crops 18
(13) Field Accumulation in Rotational Crops 18
b. Dietary Exposure (Drinking Water Sources) 19
(1) Groundwater 19
(2) Surface Water , . 20
4. Dietary Risk Assessment 23
a. Toxicologic Endpoints 23
b. Residue Information 23
c. Chronic Exposure/Risk (1MRC) 23
d. Acute Exposure/Dietary Risk 24
e. Drinking Water Risk (Ground Water) 25
(1) Acute Risk 25
(2) Chronic Risk 25
f. Drinking Water Risk (Surface Water - Acute) 25
g. Drinking Water Risk (Surface Water - Chronic) 26
5. Occupational Exposure and Risk Assessment 26
a. Summary of Use Patterns and Formulations 27
b. Occupational-use products and homeowner-use products
. • . . 27
c. Additional Occupational Exposure Studies . . 27
6. Food Quality Protection Act Considerations 27
a. Potential Risks to Infants and Children 27
(1) Developmental and Reproductive Effects 28
(2) Uncertainty Factor 28
(3) Aggregate Exposure/Risk 28
(4) Total dietary (food source and drinking water) ... 29
b. Cumulative Effects 30
C. Environmental Assessment '. . 31
1. Ecological Toxicity Data . 31
a. Toxicity to Terrestrial Animals 31
(1) Birds, Acute and Subacute 31
(2) Birds, Chronic 32
(3) Mammals . 32
(4) Insects 32
b. Toxicity to Aquatic Animals 33
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IV.
(1) Freshwater Fish, Acute . . 33
(2) Freshwater Fish, Chronic '........... 34
(3) Freshwater Invertebrates, Acute . . . . . 34
. (4) Freshwater Invertebrates, Chronic 34
(5) Estuarine and Marine Fish, Acute 34
(6) Estuarine and Marine Fish, Chronic 35
(7) Estuarine and Marine Invertebrates, Acute ..... 35
(8) Estuarine and Marine Invertebrate, Chronic .... 36
c. Toxicity to Plants '. 36
(1) Terrestrial .36
(2) Aquatic 38
2. Environmental Fate 39
a. Environmental Fate Assessment 39
b. Environmental Fate and Transport 40
(1) Degradation 40
(2) Mobility 44
(3) Accumulation 46
(4) Field Dissipation 46
(5) Spray Drift . . 48
c. Water Resources . 48
(1) Ground Water 49
(2) Surface Water 55
3. Exposure and Risk Characterization . . 59
a. Ecological Exposure and Risk Characterization .61
(1) Exposure and Risk to Nontarget Terrestrial Animals
, . 61
(2) Exposure and Risk to Nontarget Aquatic Freshwater
Animals .......... 64
(3) Exposure and Risk to Nontarget Plants , . ...... 66
(4) Endangered Species 70
b. Water Resources Risk Implication for Human Health ... 70
(1) Ground Water 70
(2) Surface Water . 71
4. Environmental Risk Characterization 71
5. Integrated Risk Characterization . . 72
RISK MANAGEMENT AND REREGISTRATION DECISION 77
A. Determination of Eligibility .'.... , . .77
B. Determination of Eligibility Decision . . 77
1. Eligibility Decision '...'...'.'.'.':'.'.'.'.'.'.'. ] ] 77
2. Eligible and Ineligible Uses .78
C. Regulatory Position 78
1. Food Quality Protection Act Findings .;...... 78
a. Determination of Safety for U.S. Population . 78
b. Determination of Safety for Infants and Children ...... 79
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2. Tolerance Reassessment . , . 80
a. Tolerances Listed Under 40 CFR §180.209(a) 80
b. Tolerances Listed Under 40 CFR §180.209(b) 81
c. Codex Harmonization 83
3. Tolerance Revocations and Import Tolerances 83
4. Ecological Effects : 83
5. Endangered Species Statement 84
6. Surface Water . . . 84
7. Ground Water 84
8. Occupational Labeling Rationale/Risk Mitigation 85
a. The Worker Protection Standard (WPS) 85
b. Personal Protective Equipment/Engineering Controls for
Handlers . 85
(1) Occupational-Use Products 85
(2) Homeowner Use Products 86
c. Post-Application/Entry Restrictions . 86
(1) Restricted Entry Interval 86
(2) Early Entry PPE 87
(3) WPS Double Notification Statement 88
(4) Entry Restrictions for Occupational-Use Products
(Non-WPS Uses) 88
d. Other Labeling Requirements 88
9. Spray Drift Advisory 88
V. ACTIONS REQUIRED OF REGISTRANTS 88
A- Manufacturing-Use Products 89
1. Additional Generic Data Requirements 89
2. Labeling Requirements for Manufacturing-Use Products 89
B. End-Use Products . 91
1. Additional Product-Specific Data Requirements 91
2. PPE/Engineering Control Requirements for Pesticide Handlers . 91
a. Minimum PPE/Engineering Control Requirements 91
b. Actual end-use product PPE requirements 91
c. Placement in labeling . 92
3. Entry Restrictions 92
a. Restricted-entry interval 92
b. Early-entry personal protective equipment (PPE) 92
c. Placement in labeling 92
4. Spray Drift Labeling 92
5. Other Labeling Requirements 93
6. Existing Stocks : . 96
VI. APPENDICES . 99
APPENDIX A. Table of Use Patterns Subject to Reregistration 100
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APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision ......... 112
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of TERBACEL ................ 117
APPENDIX D. Combined Generic and Product Specific Data Call-in . . 135
Attachment 1. Chemical Status Sheets 155
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions
• . . ... • . .". . 157
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions , . 161
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 169
Attachment 5. List of AH Registrants Sent This Data Call-in (insert)
Notice 171
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions . . . 172
APPENDIX E. List of Available Related Documents 178
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Tables
Table 1: Various U.S. Crops Treated Annually with Terbacil 4
Table 2: Acute Toxicity Data for Terbacil • • • • 7
Table 3: Summary of Toxicological Endpoints for Terbacil 12
Table 4: Terbacil and its Metabolites 14
Table 5: Avian Acute Oral Toxicity 31
Table 6: Avian Subacute Dietary Toxicity 31
Table 7: Mammalian Toxicity 32
Table 8: Nontarget Insect Acute Contact Toxicity 33
Table 9: Freshwater Fish Acute Toxicity 33
Table 10: Freshwater Invertebrate Acute Toxicity : 34
Table 10: Estuarine/Marine Fish Acute Toxicity 35
Table 10: Estuarine/Marine Invertebrate Acute Toxicity 35
Table 11: Nontarget Terrestrial Plant Seedling Emergence Toxicity (Tier IT) 37
Table 12: Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier n) 38
Table 13: Nontarget Aquatic Plant Toxicity (Tier n) 39
Table 14: Leaching potential of terbacil compared with some major use herbicides . . 49
Table 15: Leaching potential of terbacil compared with herbicides with similar use
patterns 50
Table 15: Data Used for GENEEC and PRZM- EXAMS Modeling 56
Table 16: Estimated Environmental Concentrations (EECs) For Aquatic Exposure . . 56
Table 17: Tier TL PRZM-EXAMS Modeling Input Parameters 57
Table 18: Tier H Maximum PRZM-EXAMS Aquatic Estimated Environmental
Concentrations for Terbacil. . 58
Table 19: Risk Presumptions for Terrestrial Animals 61
Table 20: Risk Presumptions for Aquatic Animals 61
Table 21: Risk Presumptions for Non-Target Plants 61
Table 22: Estimated Environmental Concentrations on Avian and Mammalian Food
Items 62
Table 23: Avian Acute Risk Quotients for Single Application of Nongranular Products
(Broadcast) Based on pheasant1 LC.^21,141 ppma.i 62
Table 24 : Mammalian (Herbivore/Insectivore) Acute Risk Quotients for Single
Application of Nongranular Products (Broadcast) of Terbacil 63
Table 25: Mammalian Chronic Risk Quotients for Terbacil Based on a Rat NOEL >250
ppm in a 3-generation rat study 64
Table 26: Estimated Environmental Concentrations (Ibs a.i./A) For Terrestrial and Semi-
Aquatic Plants for a Single Application 67
Table 27: Acute High Risk Quotients from a Single Application for Terrestrial and Semi-
Aquatic Plants 68
Table 28: Acute Risk Quotients for Aquatic Plants based upon a duckweed 69
Table 29: Typical Terbacil Use Rates 76
Table 30: Tolerance Reassessment Summary for Terbacil 82
Table 31: Typical Terbacil Use Rates . 90
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TERBACIL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Neil Anderson
Jihad Alsadek
Herbicide/Insecticide Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
James Hetrick
David Wells
Michael Davy
, Mah Shamim
Health Effects Risk Assessment
Jack Arthur
Melba Morrow
David Miller
Brian Steinwand
Registration Support Risk Assessment
Wesley Allen
Debbie McCall
Vickie Walters
Risk Management
Emily Mitchell
Joseph Bailey
Environmental Risk Branch I
Environmental Risk Branch JJ
Environmental Risk Branch JJ
Environmental Risk Branch IV
Risk Characterization and Analysis Branch
Registration Action Branch 1
Chemistry and Exposure Branch 2
Chemistry and Exposure Branch 1
Fungicide-Herbicide Branch
Registration Support Branch
Fungicide-Herbicide Branch
Reregistration Branch I
Reregistration Branch I
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11
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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 >
CI Cation
CNS Central Nervous System '
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System . /
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, 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
LCSO Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
; per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LDSO 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.
LDi0 Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LQC 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.
;ig/g Micrograms Per Gram
/wg/L Micrograms per liter . •
mg/L Milligrams Per Liter
MOE Margin of Exposure .•-•'.
MP Manufacturing-Use Product .
MPI Maximum Permissible Intake
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
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.
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'i 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 24® of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions
WP Wettable Powder
WPS Worker Protection Standard
IV
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ABSTRACT
This Reregistration Eligibility Decision Document (RED) addresses the reregistration
eligibility of the pesticide terbacil, which includes the active ingredient 3-tert-butyl-5-cbloro-6-
methyluracil. Products containing terbacil are registered for use as herbicides.
Terbacil was registered for use as a herbicide in the United States in 1966. This decision
includes a comprehensive reassessment of the required target data and the use patterns of currently
registered products, Terbacil is a selective herbicide, formulated as a wettable powder, and is
applied by aircraft or ground equipment on terrestrial food/feed crops (e.g., apples,
mint/peppermint/spearmint, sugarcane, and ornamentals), forestry (e.g., cottonwood
(forest/shelterbelt), terrestrial food (e.g., asparagus, blackberry, boysenberry, dewberry,
loganberry, peach, raspberry, youngberry and strawberry), and terrestrial feed (e.g., alfalfa,
sainfoin (hay and fodder), and forage). Products containing terbacil are not currently registered
for residential use.
The Agency has concluded that all uses, as prescribed in this document, will not cause
unreasonable risks to humans or the environment and therefore, all products are eligible for
reregistration.
Short and intermediate term toxicity endpoints sufficient to be of occupational concern
were not identified for terbacil. The oral and dermal LDSO and dermal irritation studies all
resulted in Category IV toxicity classifications. Inhalation and eye irritation studies gave results
to meet Category m requirements, and no dermal sensitization was found. Because of these
findings, risk assessments were not necessary for occupational exposure scenarios, and therefore,
are not factored into aggregate risk calculations.
Developmental toxicity was selected as the endpoint of concern for acute dietary risk
(NOEL of 12.5 mg/kg/day, based on the decrease in the number of live fetuses seen at the next
highest dose level in a rat study). All dietary food and drinking water sources of terbacil were
analyzed relative to this NOEL, for females of child-bearing age (i.e., 13+ years-old). Based
on these analyses, acute dietary exposure is not a concern for terbacil. Animal tests showed no
evidence of carcinogenicity for terbacil (i.e., classified as E).
To assess the potential risks to infants and children under the new Food Quality Protection
Act (FQPA), the Agency evaluated two developmental studies and one reproduction study.
Because the developmental NOELs were the same as those for maternal toxicity, and the NOEL
for systemic toxicity was higher than the NOEL for reproductive toxicity in these studies, the data •
do not suggest an increased pre- or post-natal sensitivity of children and infants exposure to
terbacil. The standard 100-fold uncertainty factor is considered by the Agency to be sufficiently
protective of infants and children, and an additional safety factor is not warranted.
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The reference dose (RfD) for terbacil is 0.013 mg/kg/day, based on increased liver
weights and serum alkaline phosphatase in dogs at the next highest dose level, and an uncertainty
factor of 100.
Chronic dietary risks from food sources (expressed as %RfD) were calculated by the
DRES model which used tolerance values for food crops before and after adjustments had been
made (e.g., recommendations are made to revoke tolerances for citrus fruits and pears, and raise
tolerances on caneberries, blueberries, peaches, apples and sugarcane). None of the scenarios
for chronic dietary risk from food sources resulted in values that concern the Agency.
Chronic dietary risks from drinking water were analyzed for surface water using the
results from a Tier Two model (PRZM), which gives values for each crop separately. Because
of conservative model parameters, it is expected to over-estimate terbacil concentrations in
drinking water. None of the scenarios exceeded 100% of the RfD. None of the aggregate risk
numbers exceeded the RfD.
Terbacil is a persistent and potentially mobile herbicide in terrestrial environments. These
environmental fate properties suggest terbacil can potentially move into both ground and surface
waters. Tier n surface modeling suggest terbacil may potentially accumulate in surface water at
concentrations from 28 to 1470 pcg/L. Further analysis of Tier n peak Estimated Environmental
Concentration (EECs) indicate the first year EEC and annual incremental concentration (slope)
were 105 and 36 ^g/L for Louisiana sugarcane; 24 and 4.3 /*g/L for New York apples; 34 and
0.00 jig/L for Georgia peaches; and 5.2 and 0.52 /ig/L for Washington apples. The peak ground
water concentration, based on the Ground Water Interactive Concentration (GWIC) screening
model, is not expected to exceed 125 jig/L. Since reliable ground and surface water monitoring
data are not available, estimated environmental concentrations of terbacil are based solely on
ground and surface water models.
All environmental fate data are fulfilled at this time. However, additional information on
the aerobic aquatic metabolism (Guideline 162-4) of terbacil is needed because terbacil is likely
to move into surface waters. These data will provide a more realistic assessment of terbacil
concentrations in surface waters.
All ecological toxicity data are fulfilled except for chronic avian and aquatic toxicity
studies (Guideline 71-4 Avian Reproduction Study; Guideline 72-4 Fish Early Life Stage and
Aquatic Invertebrate Life Cycle). These data are needed because terbacil is a persistent compound
which may pose long-term exposure in terrestrial and aquatic environments. Wild mammal
toxicity study (Guideline 71-3) is reserved pending the result of avian reproduction studies
(Guideline 71-4).
Minimal adverse acute effects are expected for avian, mammalian, and aquatic species
from labeled terbacil uses. Chronic effects for avian and aquatic species cannot be evaluated
because of insufficient data. However, chronic RQs for mammals indicate adverse effects are
possible from terbacil labeled uses. The rat reproductive study shows the NOEL to be higher than
VI
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the greatest concentration tested. This concentration is below the maximum and mean predicted
residue values (Kenaga/Fletcher) on mammalian food items. Since the rat reproductive endpoint
is greater than the highest concentration tested, EPA used that concentration level as a default
toxic reproductive endpoint. This, assumption's more conservative and protective because toxic
endpoints are expected to be higher than the default NOEL level. Based on the Agency's
assessment, no evidence of carcinogenicily was detected. The Agency's mammal chronic feeding
, toxicity Studies indicate there may be increased liver and thyroid weights for rats. Since terbacil
is a persistent and mobile herbicide, non-target terrestrial plants are expected to be adversely
effected from runoff and spray drift. Minimal adverse effects, however,. are expected for non-
target aquatic plants. The fact that terbacil is used exclusively on minor crops, terbacil exposure
is expected to be very localized and dependent on site specific conditions. The localized nature
of terbacil use is expected to limit human and ecological exposure.
Before reregistering the products containing terbacil, 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 toxiciry 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.
Vll
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and 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 reregistration.
' I ' '
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration 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 etseq., 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,
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 safety standard and how it should be applied to both food and non-food
pesticide applications. The FQPA did not, however, amend any of the existing reregistration
deadlines hi section 4 of FIFRA. The Agency will therefore 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 terbacil including the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA.
The document consists of six sections. Section I is the introduction. Section n describes terbacil,
its uses, data requirements and regulatory history. -Section HI discusses the human health and
environmental assessment based on the data available to the Agency.; Section IV presents the
reregistration decision for terbacil . Section V discusses the reregistration requirements for
terbacil '. Finally, Section VI is the Appendices which support this Reregistration Eligibility
Decision. Additional details concerning the Agency's review of applicable data are available on
request.
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H. CASE OVERVIEW
A. Chemical Overview
t
The following active ingredient(s) are covered by this Reregistration Eligibility
Decision:
• Common Name: Terbacil
• Chemical Name: 3-tert-butyl-5-chloro-6-methyluracil
• Other Chemical Nomenclature: 5-chloro-3-(l,l-dimethylethyl)-6-methyl-
2,4(lH,3H)-pyrimidinedione
• CAS Registry Number: 5902-51-2
• OPP Chemical Code: 012701
• Empirical Formula: C9H13C1N2O2
• Trade and Other Names: Sinbar*, DuPont Herbicide 732, and Geonter
• Basic Manufacturer: E.I. DuPont de Nemours Company, Inc.
!
1. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of the uses of terbacil is in Appendix
**•• ^,
For Terbacil:
Type of Pesticide: Herbicide
Use Sites: Terrestrial Food and Feed Crop:
apples, mint/peppermint/spearmint, sugarcane, and ornamentals
Forestry:
cottonwood (forest/shelterbelt)
Terrestrial Food:
asparagus, blackberry, boysenberry, dewberry, loganberry, peach,
raspberry, youngberry, and strawberry
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Terrestrial Feed: .
alfalfa and sainfoin (hay and fodder), and forage
Target Pests: A broad spectrum of broadleaf weeds and grasses
Formulation Types Registered:
Wettable Powder 80% &
Wettable Powder 40%
Method and Rates of Application:
Equipment - Boom Sprayer & Aircraft
Method and Rate -
Tractor-mounted spray boom application to soil
surface and small emerged weeds and aerial
application-See APPENDIX A for detailed
breakdown
Timing - Application times vary with crops.
Use Practice Limitations: Do not apply through any type of irrigation system.
Do not graze treated crop or allow hay, seeds or
seed screenings from treated, crop to be used for
food or feed. Do not graze or feed forage or hay
from treated areas to livestock.
2. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
terbaeil. 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. Table 1 below summarizes the pesticides use by site.
3
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Table 1: Various U.S. Crops Treated Annually with Terbacil
: Site
0.00
Acres Treated
{000}
Likely
Average
Lifeely
Max
% of Crop
Treated
Likely
Average
Likely
Max
LB A,!, Applied
(DOty
Likely
Average
Likely
Max
Application
Rates
L8a.i/
acre/yr
#appl
/year
States of Most Usage
AG~SUBS
Alfalfa
Apples
Asparagus
Berries*
Mint
Peaches
Sugarcane
24,338
457
86
115
140
176
936
Ag Subtotal
50
40
1
25
100
60
125
401
70
50
3
45
110
100
175
533
0.00
9
1.
22
71
34
13
0.00
1.1
4
39
79
57
19
20
40
1
5
95
10
50
221
35
50
2
20 '
115
. 25
200
447
0.4
1.0
1.0
0.2
1.0
0.2
0.4
1
1
1
1
1
1
1
NE, OK, OR, WA
WA, NY, PA
MI
WI, OR, MI, ME
OR, WA, ID
GA, SC
LA
- , ,NQN~AG SITES
Fallow
Forest Trees
Ornamental
-
2,500
200
Non-Ag Subtotal
Grand total
2
1
1
4
405
5
2
2
9
562
0.00
1 '
0.00
1
7
1
1
9
230
10
2
2
14
461
3.5
1.0
1.0
-
-
-
-
-
-
Calculations of the above numbers may not appear to agree because they are displayed as rounded.
0 = < 500 acres treated or Ib. a.i. because of rounding to the nearest 1,000.
0% = < 0.5% because of rounding to the nearest whole percentage point.
NO OBS «« No Observations. This site is covered by EPA sources, but little or no usage is observed, or may be included with
all other pesticides. For this sites a likely maximum percent treated is included, above which the actual usage is unlikely.
- = insufficient data to determine an amount for this field/
Usage data primarily covers 1990 - 1995 for most sites and as early as 1987 for some sites.
Likely averages are based on weighted averages of data with most recent years and more reliable data weighted more heavily.
Likely maximums are an amount above which the actual usage is unlikely to exceed.
Application rates are calculated from likely averages or are based on typical rather than maximum rates.
* Other/Crop Groups
Berries includes all berries.
SOURCES: EPA data, USDA, and National Center for Food and Agricultural Policy
(1) Data Requirements
Data requested in the 1989 Registration Standard for terbacil include studies on
product chemistry, toxicological effects, ecological effects, and environmental fate. These
data were required to support the uses listed in the Registration Standard. Appendix B
includes all data requirements identified by the Agency for currently registered uses
needed to support reregistration.
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3, Regulatory History
Terbacil was registered for use as a herbicide in the United States in 1966. A
Registration Standard was issued for terbacil in May 1982. Additional data was required
in the areas of product chemistry, toxicology, environmental fate and ecological effects.
In August 1989 a Registration Standard (Second Round Review) was issued for terbacil.
This document reviewed data submitted in response to the 1982 Registration Standard,
updated the Agency's assessment of the terbacil data base, and included a tolerance
reassessment. The Second Round Review required additional data in the area of
toxicology, environmental fate, ecological effects, and residue chemistry. This
Registration Eligibility Document reflects an assessment of all data submitted in response
to the Second Round Review,
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Terbacil [3-?erf-butyl-5-chloro-6-methyluracil] is a selective herbicide
used for the control of many annual and some perennial weeds in crops.
ci
Empirical Formula:
Molecular Weight:
CAS Registry No.:
OPP Chemical Code:
C9H13C1N202
216.7
5902-51-2
012701
a.
Identification of the Active Ingredient
Terbacil is a white crystalline solid with a melting point of 175-177° C.
Terbacil is soluble in water (710 ppm) at 25° C, and is moderately soluble in
organic solvents including dimethylformamide (33.7 g/100 g), cyclohexanone (22
g/100 g), and xylene (6.5 g/100 g).
(1) Manufacturing-use Products
According to a search of the Agency's Reference Files conducted 9/9/96,
there are no terbacil manufacturing-use products (MUPs) registered under the OPP
Chemical Code 012701; however, the E.I. du'Pont de Nemours and Company,
Inc. 80% wettable powder (WP; EPA Reg. No. 352-317) is manufactured from
-------
an unregistered TGAI (95%a.i.). Only the du Pont TGAI is subject to this
reregistration eligibility decision.
(2) Regulatory Background
The Terbacil Guidance Document dated 5/82 requked additional generic
product chemistry data for terbacil; however, the Terbacil Reregistration Standard
Second Round Review (SRR) dated 3/8/89, requked that all new product
chemistry data be submitted, and reviewed data submitted in response the Guidance
Document. The Terbacil SRR required additional data concerning GLNs 61-2, 61-
3, 62-1, 63-7, 63-9, 63-11, 63-12, and 63-13 (OPPTS 830.1620, 830.1670,
830.1700, 830.7300, 830.7950, and 830.7550-7570, 830.7000, and 830.6313) for
the du Pont TGAI. No new data were submitted/reviewed under the Terbacil
Reregistration Standard Update dated 10/8/91.
(3) Conclusions for Product Chemistry
All pertinent data requirements are satisfied for the du Pont TGAI except
for a new data requirement concerning UV/visible absorption for the TGAI
(OPPTS GLN 830.7050). The registrant should submit the data required for the
terbacil TGAI, or either certify that the suppliers of beginning materials and the
manufacturing process for the TGAI have not changed since the kst comprehensive
product chemistry review or submit a complete updated product chemistry data
package.
B. Human Health Assessment
1. Hazard Assessment
The toxicology data base for terbacil is adequate and will support the
reregistration eligibility of this chemical.
a. Acute Toxicity
Terbacil 80% wettable powder (WP) has been tested in acute oral
toxicity studies with rats (Ace. Nos. 114693 and 24955) and has an acute
oral LD50 of > 5,000 mg/kg/day (Toxicity Category IV). In an acute
dermal toxicity study in rabbits, the LD50 was > 5,000 mg/kg/day
(Toxicity Category IV), with no toxic signs noted (Ace. Nos. 114693 and
24955). Technical terbacil (97.8%) was tested in an acute inhalation study
in rats (MRID 00125700), which indicated that the LC50 was > 4.4 mg/L
(Toxicity Category TH). Technical terbacil (96.1 %) was tested in rabbits'
eyes and produced only mild conjunctiva! effects, which cleared within 72
hours (Toxicity Category ffl). Although a primary dermal irritation study
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is not available on technical terbacil, the Agency had indicated to the
Registrant that if no dermal irritation was observed in a 21-day subchronic
dermal study, then the requirements for the primary dermal irritation study
would be satisfied (Tox. Doc. 003401). No dermal irritation was reported
in that study (MRID 00125785). Terbacil is not a dermal sensitizing agent
in guinea pigs (Ace. Nos. 157180). Table 2 below summarizes the values
and toxicity categories for the various acute toxicity routes.
Table 2: Acute Toxicity Data for Terbacil
Test - -
Oral LD50
Inhalation LCSO
Dermal LD30
Eye Irritation
Dermal Irritation
Dermal Sensitization
%AI
80.0
97.8
80.0
96.1
80.0
96.1
Result
> 5000 Tag/kg/day
> 4.4mg/L
> 5000 mg/kg/day r
Mild conjunctiva! irritant up to 7? hours
Not a skin irritant
Not a dermal sensitizer
i Category
IV
m
IV
m
IVs
a Based on a 21-day dermal toxicity study in rabbits.
b. Subchronic Toxicity
Subchronic oral toxicity was tested in a 90-day feeding study in rats
£MRIDs 00039009 and 00068035). A NOEL of 100 ppm (equivalent to 5
mg/kg/day) and LOEL of 500 ppm, equivalent to 25 mg/kg/day (HDT)
were established, based on increased absolute and relative liver weights,
vacuolization and hypertrophy of hepatocytes. The data requirement for
subchronic oral toxicity in a nonrodent was satisfied by a 2-year feeding
study in beagle dogs (MRID 00060851), in which a NOEL of 50 ppm
(equivalent to 1.25 mg/kg/day) and LOEL of 250 ppm (equivalent to 72
mg/kg/day) were established, based on increased thyroid to body weight
ratios, slight increase in liver weights, and elevated alkaline phosphatase
levels. , "
Subchronic dermal toxicity was tested in a 21-day study in rabbits
(MRID 125785). Terbacil (80% a.i.) was applied to prepared skin of male
and female rabbits at 5,000 mg/kg/day, 5 hours/day, 5 days/week. No
systemic toxicity was observed; mild scaling and staining were reported at
the test sites. -.'
c. Chronic toxicity,
Terbacil 80% a.i. was administered to beagle dogs (4/sex/group) in
the diet for 2 years, at doses of 50, 250, or 2,500/10,000 ppm, equivalent
-------
to 1.25, 6.25, 62.5/250 mg/kg/day (MRID 00060851). The NOEL was
50 ppm (1.25 mg/kg/day), and the LOEL was 250 ppm (equivalent to 6.25
mg/kg/day), based on increased thyroid to body weight ratios, slight
increase in liver weights, and elevated alkaline phosphatase levels. Relative
liver weights were also increased at 2,500 and 10,000 ppm in dogs
sacrificed at 1 year and 2 years.
A 2-year rat study (MRID 42987601) was supplied to the Agency
in response to the Registration Standard Data Call-in notice. In this study,
terbacil 97.4% a.i. was administered to male and female Sprague-Dawley
Crl:CD BR rats at dietary levels of 0, 25, 1500, or 7500 ppm (approximate
doses for males of 0, 0.9, 58, and 308 mg/kg/day and for females of 0,
1.4, 83, and 484 mg/kg/day). Ten animals/sex/dose were sacrificed by
study design at 12 months. Excessive mortality was observed in the control
and low dose groups, and the study was terminated at 23 months. No
clinical signs relating to dosing were reported. Body weight was
significantly reduced in males receiving 7500 ppm and in females receiving
1500 and 7500 ppm throughout most of the study. At 51 weeks, body
weight gain in males receiving 7500 ppm was 13 % lower than controls and
in females receiving 1500 ppm and 7500 ppm gains were 18% and 39%
lower than in controls. No lexicologically significant changes in
hematology parameters were observed.
Serum cholesterol was significantly increased in high dose females
at all reporting periods. A marginal increase was observed in mid-dose
females. A slight increase was observed in 7500 ppm males at 18 and 24
months but only the increase at 18 months was significant compared to
controls.
At 1500 ppm, a significant increase in the mean liver to body
weight ratio was observed in females at 12 months (16%) and at study
termination (21%). At termination, the liver weight increase was
accompanied by a marginally increased incidence of centrilobular
hepatocyte hypertrophy (minimal) and a 20% decrease in mean body
weight. At 7500 ppm, significant increases in liver to body weight ratios
were seen in both sexes at 12 and 23 months and mean liver weight in
males was 20% increased compared to controls at study termination.
Centrilobular hypertrophy as well as fatty changes were seen in both
sexes at the high dose and an increase in biliary hyperplasia was observed
in high dose females. Eosinophilic foci of cellular alteration in the liver
were increased in incidence in dosed groups of male and females with a
significant trend. However, this is of equivocal importance because it was
not accompanied by hypertrophic or hyperplastic changes or hepatocellular
8
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tumors. The systemic NOEL is 25 pjpm (0.9 mg/kg/day for males and 1.4
mg/kg/day for females) and the LOEL is 1500 ppm (56 mg/kg/day for
males and 83 mg/kg/day for females) based on the liver effects and
decreased body weight gain in females. The study was conducted at
adequate dosages as demonstrated by the decrement in body weight gain in,
both sexes. There was no evidence of increased tumor incidence in the
treated animals when compared to the controls.
d. Carcinogenicity
Terbacil has been tested in a chronic 2-year feeding/oncogenicity
study in mice (MRID 00126770) at doses of 0, 50, 1250, or 5000/7500
ppm (equivalent to 7, 179, 714/1071 mg/kg/day) The increase in dose
occurred after week 54. A systemic NOEL of 50 ppm is based on the
LOEL of 1250 ppm which resulted hi mild hypertrophy of the centrilobular
hepatocytes, and decreased pituitary weights in males. Pituitary weight
was also decreased hi high-dose females. There was an increased incidence
of lung neoplasms (adenomas and adenocarcinomas) in all treated male
mice, which was not dose-related; hi addition, these tumors were within the
range of similar tumorss observed in historical control mice. Additional
information (MRID 42031601), provided by the registrant demonstrated
that, under the conditions of this study, administration of terbacil did not
significantly increase the incidence of any proliferative hepatocellular
carcinoma, single/multiple adenomas, or foci of cellular alteration, or
combined hepatocellular adenomas and carcinomas, in either sex.
Guideline requirements for 83-2 are satisfied by this information.
Terbacil was also tested in the rat (MRID 42987601, described
under chronic feeding toxicity studies, above). Under the study conditions,
terbacil did not induce any increase in tumor incidence in the treated
animals. ,
e. Developmental Toxicity
Terbacil has been tested in rats and rabbits for its potential to
produce developmental toxicity. Rats (MRID 00039001) were fed 0, 250,
1,250 or 5,000 ppm (equivalent to 0, 12,5, 62.5 or 250 mg/kg/day) of
terbacil in the diet from days 6 through 15 of gestation. The study .was
graded core-Supplementary, because of concerns raised about an increased
number of pre-implantation losses and increased hydronephrosisln fetuses
from the treated dams. These concerns were subsequently addressed by the
registrant to the satisfaction of the Agency. The developmental NOEL was
250 ppm (12.5 mg/kg/day); the developmental LOEL of 1250 ppm (62.5
mg/kg/day) was based upon significantly decreased number of live fetuses
-------
per litter, apparently due to fetal loss occurring before or near the time of
implantation. The maternal NOEL was 250 ppm (12.5 mg/kg/day), based
on decreased body weight at 1,250 ppm (62.5 mg/kg/day).
Rabbits were given doses of terbacil of 0, 30, 200, or 600
mg/kg/day by gavage, on gestation days 7 through 19 (MRID 00150945).
The maternal NOEL was 200 mg/kg/day, based on maternal deaths (5 died
and 2 were sacrificed in extremist at the LOEL of 600 mg/kg/day. The
developmental NOEL was also 200 mg/kg/day based on decreased live fetal
weights in the high dose group (i.e., 600 mg/kg/day).
f . Reproductive Toxicity
Terbacil was tested in male and female rats at control (i.e., 0 ppm)
and dietary levels of 50 or 250 ppm (equivalent to 2.5 or 12.5 mg/kg/day),
over three generations (MRID 00060852). The first litter of each
generation was discarded, and the second litter bred to produce the next
generation. The study was reviewed for the 1982 Registration Standard,
and graded core-Supplementary, based on testing only 2 dose levels and the
use of antibiotics on the test animals during the study. In addition,
necropsy records were not available for the first litters, and the breeding
records were incomplete. After addressing these concerns (Ace. No.
249455), the study was upgraded to core-Minimum (Tox. Doc. 003401),
with a systemic NOEL of equal to or less than 50 ppm (2.5 mg/kg/day),
based on the reduction of body weight gain in male offspring at the 250
ppm dietary level. Because the weight gain appeared at late periods in the
study, and not in the early development of the offspring, this effect is not
considered to be reproductive effect. No reproductive effects were seen
at the highest dose tested, therefore, the NOEL for reproductive toxicity
was equal to, or greater than 250 ppm (12.5 mg/kg/day).
g. Mutagenicity
Terbacil technical (96.1%) was tested and found negative for
clastogenicity in a chromosomal aberration study in rat bone marrow cells,
at doses up to 500 mg/kg (MRID 00157181). It was also negative in a
CHO (HGPRT) gene mutation assay (Ace. No. 260460) when tested up
to cytotoxic levels, with and without S-9 activation (cytotoxicity > 3.0
mM without activation; > 2.75 mM with activation). Terbacil technical
was also negative for unscheduled DNA synthesis when tested up to
cytotoxic levels (5 mM) in the rat.
10
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h. Metabolism
Radiolabeled terbacil was tested in rats (MRID 40104702) in single
doses of 6.5 or 500 mg/kg; 97 to 103% of radioactivity was recovered
within 5 days: 70-86% in urine, and 28% in feces. The major metabolites
were glucuronide, sulfate, and N-acetylcysteine conjugates. The primary
metabolic"pathway is hydroxylation of the 6-methyl group to form the
alcohol, which is conjugated to form the glucuronide (35% of the dose) and
the sulfate derivatives (11%). Terbacil js also metabolized to the 5-
hydroxy intermediate, which is further conjugated to form a. sulfate
derivative (17%).
2. Toxicological Endpoint of Concern Used in Risk Assessment
a. Reference Dose
The reference dose (RfD) for systemic toxicity was determined for
terbacil as 0.013 mg/kg/day, by the.* Agency's RfD Committee in May,
1986. This was verified by the Agency's Review Committee in June,
1986. The RfD was calculated from a two-year feeding study in dogs
(MRID 00060851) in which the NOEL was 1.25 mg/kg/day (based on
increased relative liver weights and increased serum alkaline phosphatase,
seen at 7.25 mg/kg/day), and an uncertainty factor of 100. The RfD of
0.013 mg/kg/day was reaffirmed by the Agency's RfD Committee on
September 1, 1994.
b. Carcmogemcity Classification
Terbacil was classified in Group E (no evidence of carcinogenicity
in animal studies) with respect to its carcinogenicity potential.
c. Other Toxicological Endpoints
Based upon a review of the TES Committee, the database for
terbacil, a toxicology endpoint and the dose level of concern have been
identified. Findings of the TES Committee are discussed and summarized
in the Table 3 below.
11
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Table 3: Summary of
Toxicological Endpoints for Terbacil
Exposure Duration
Acute
Short-Term (1-7 days)
Occupational/Residential
Intermediate-Term (one
week to several months)
Occupational/Residential
All time periods
Chronic
Exposure Route
Ingestion
Dermal
Dermal
Inhalation
Ingestion
Endpoiiit and Toxicological Effect
Developmental NOEL (12.5 mg/kg/day): based on a decrease in
number of live fetuses seen at 62.5 mg/kg/day in a rat
developmental study.
None identified.
None identified.
None identified.
RfD (0.013 mg/kg/day) based on increased thyroid: body weight
ratio, slight increase in liver weight and elevated alkaline
phosphatase seen at 7.2 mg/kg/day in a 2-year dog study.
(1) Acute Dietary
To estimate acute dietary risk, the endpoint selected was
developmental toxicity. Female Sprague Dawley rats were
administered terbacil at dietary doses of 250, 1250, or 5000 ppm
(12.5, 62.5 or 250 mg/kg) on gestation day 6 through 15 (MRID
No. 00039001). The developmental NOEL was 250 ppm (12.5
mg/kg/day); the developmental LOEL of 1250 ppm (62.5
mg/kg/day) was based upon significantly decreased number of live
fetuses per litter, apparently due to fetal loss occurring before or
near the time of implantation. The maternal NOEL was 250 ppm
(12.5 mg/kg/day), based on decreased body weight at 1250 ppm
(62.5 mg/kg/day). A risk assessment for acute dietary exposure is
required.
It was noted that, although the compound was administered
for a period that exceeded one day, the study was selected for the
determination of acute dietary risk because it is uncertain whether
the observed developmental toxicity resulted from exposure on the
first day of dosing or resulted from cumulative exposure during the
10 day period that corresponded to organogenesis.
(2) Dermal Absorption
Dermal absorption data were not available for terbacil. It
was assumed by the TES Committee that there would be 100%
absorption.
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(3) Short and Intermediate Term Occupational
The results of a 3-week dermal study conducted with rabbits
demonstrated that at doses as high as 5000 mg/kg/day, there were
no toxic signs or histopathological lesions that could be associated
with the administration of the test material. Furthermore, in a 90-
* day feeding study with rats (doses tested: 100, 500 and 5000 ppm)
there appeared to be low toxicity associated with the administration
of the compound based on the observation of adaptive hepatic
alterations of increased liver weight and hepatic vacuolation and
hypertrophy at 500 ppm (25 mg/kg/day).
Because of these results, the TES Document stated that risk
assessments for both short and intermediate term occupational or
residential exposure are not required.
(4) Chronic Occupational (Non-Cancer)
The TES Document (12/01/94) identified no chronic toxicity
endpoints to assess chronic occupational exposure and risk. A 2-
year chronic feeding study in dogs was used for establishment of the
RfD (0.013 mg/kg/day) to evaluate dietary exposures and risk. The
lowest exposure level at which effects were seen in this study was
6.25 mg/kg/day. Because the chronic dose level at which effects
were seen is relatively high, coupled with the fact that the 2-year
duration of the study is longer than normally required for chronic
toxicity studies ( usually require only one year of dosing).
3. Exposure Assessment
a. Dietary Exposure (Food Sources)
Tolerances for residues of terbacil in/on apples, citrus, peaches,
pears, and sugarcane are currently expressed in terms of terbacil per se [40
CFR §180.209(a)]. Tolerances for residues of terbacil on other plant and
animal commodities are expressed as the combined residues of terbacil and
its metabolites, 3-rerr-butyl-5-chloro-6-hydroxymethyluracil (Metabolite
A), 6-chloro-2,3-dihydro-7-hydroxymethyl-3,3-dimethyl-5H-oxazolo (3,2-
a) pyrimidin-5-one (Metabolite B), 6-chloro-2,3-dihydro-3,3,7-trimethyl-
5H-oxazolo (3,2-a) "pyrimidin-5-one (Metabolite C), each calculated as
terbacil [40 CFR §180.209(b)]. Tolerances range from 0.1 ppm for animal
commodities, berries, and pecans to 5 ppm on forage and hay of alfalfa'and
sainfoin. No food/feed additive tolerances have been established for
13
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residues of terbacil. Adequate methods are available for the enforcement
of established tolerances, as currently defined.
The residues to be regulated in plants and animals are terbacil and
its three currently regulated metabolites. The chemical names and
structures of the terbacil residues of concern are depicted in Table 4.
Table 4: Terbacil and its Metabolites
Common Name/Chemical Name
Chemical Structure
Terbacil
3-fert-butyl-5-chloro-6-methyluracil
ci
Metabolite A
IN-G2449
3-te/t-butyl-5-chloro-6-
hydroxymethyluracil
Metabolite B
IN-W2207
6-chloro-2,3-dihydro-7-
hydroxymethyl-3,3-dimethyl-5H-
oxazolo (3,2-a) pyrimidin-5-one
KOCH,
Metabolite C
IN-T2170
6-chloro-2,3-dihydro-3,3,7-trimethyl-
5H-oxazolo (3,2-a) pyrimidin-5-one
(1) Directions for Use
A search of the Agency's Reference Files on 9/27/96
indicates that there is one terbacil end-use product (EPA Reg. No.
352-317, label dated 3/5/96) with food/feed uses registered to E. I.
du Pont de Nemours & Company Inc. This product is formulated
14
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as a 80% WP and is marketed under the trade name Sinbar®. The
following special local need (SLN) labels for use on alfalfa are
associated with this product: SLN Nos. OK920009, OR920003,
PA900003, VA900004, and WA'930007. These SLNs should be
canceled and the use directions incorporated into the federal label.
Three additional SLN labels are registered for use on grasses grown
for seed (SLN Nos. ID800009, OR800021, and WA800010).
These labels prohibit the grazing of treated fields and the feeding of
seed or crop residues from treated areas to livestock. Given the use
in only three states in the Pacific Northwest and the limited number
of varieties on which use is permitted, the Agency believes that this
restriction is appropriate in this instance.
Under the "General Information" section of the label (EPA
Reg. No. 352-317), pecans are fisted as a crop to which Sinbar®
can be applied; however, no use directions for pecans are included
on the label. The reference to pecans should be deleted from the
label. In addition, a 150-day preharvest interval (PHI) should be
specified for sugarcane and a 60-day PHI should be specified for
apples. The label instructions for asparagus should be clarified to
indicate a maximum seasonal rate of 3 Ibs a.i./A.
(2) Nature of the Residue in Plants
The qualitative nature of the residue in plants is adequately
understood based on alfalfa, blueberry, arid sugarcane metabolism
studies. The residues to be regulated in plants are terbacil and its
metabolites A, B; and C.
(3) Nature of the Residue in Livestock
The qualitative nature of the residue in animals is adequately
understood based upon acceptable ruminant and poultry metabolism
studies,, The residues of concern in animals are terbacil and its
metabolites A, B, and G. However, the Agency has determined
that based on CFR part 180.6(a)(3), there is no likelihood of finite
residues. Therefore, tolerances in these commodities are not
necessary (see "Magnitude of the Residue in Meat, Milk, Poultry,
and Eggs").
(4) Residue Analytical Methods
Adequate analytical methodology is available for data
collection and enforcing terbacil tolerances. Method I in the
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Pesticide Analytical Manual (PAM), Vol. II, is a
GLC/microcoulometric detector (MCD) method that determines
terbacil per se and has undergone a successful EPA method
validation on oranges and peaches. As metabolites A, B, and C are
not determined by Method I, this method is no longer adequate for
tolerance enforcement. .
Method n in PAM, Vol. n determines terbacil and its three
regulated metabolites in plants and has undergone a successful EPA
method validation on alfalfa. Residues are extracted into
chloroform, further purified, and then silylated for GC analysis.
Silylated residues are quantified by GC using a halogen-sensitive
microcoulometric detector. The reported limits of detection for
each analyte are 0.1 ppm in mint oil and hay and 0.04 ppm in other
plant commodities. A confirmatory GC/MSD method is also listed
in PAM Vol. H as Method A.
»-
Data from analysis of terbacil residues in/on plants have
been collected using PAM Methods I and IE, and more recently
using an adequate GC/nitrogen-phosphorus detector (NPD) method,
which is a modification of Method II in PAM. For this GC/NPD
method, residues of terbacil and its metabolites are extracted into
chlorofbrmrwater and cleaned-up by liquid-liquid partitioning prior
to derivatization with bis(trimethylsilyl)trifluoroacetamide and
trimethylchlorosilane (BSTFA +1% TMCS). Silylated residues
are then further purified using sodium sulfate and Florisil columns
and then quantified by GC/NPD. The reported limit of detection
is 0.05 ppm for each analyte.
As Method I in PAM is no longer an acceptable enforcement
method and Method n utilizes an obsolete microcoulometric
detector, the Agency will require the registrant to submit the
GC/NPD method for a Tolerance Method Validation prior to
inclusion in PAM as an enforcement method. As the method is an
improved method, we will not require that DuPont conduct any
independent method validation.
(5) Multi-residue Method Testing
Data have been submitted pertaining to the analytical
behavior of terbacil and its regulated metabolites through FDA
Multiresidue Protocols and have been forwarded to FDA for
inclusion in PAM Vol. I. The registrant has submitted the results
of FDA Multiresidue Protocol C to the Agency (Protocols A, B,
16
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and E are not applicable) which demonstrates that terbacil and its
metabolites are completely recovered. Results from Protocol D
were not submitted, and the registrant is required to use this method
to test an appropriate commodity and submit the results for terbacil
and its regulated metabolites for inclusion in PAM.
(6) Storage Stability Data
Requirements for storage stability data are satisfied for
.purposes of reregistration. Adequate storage stability data have
been submitted for terbacil residues in RACs commodities of.
alfalfa, apples, blueberry, mint, milk, and sugarcane. These data
indicate that terbacil and metabolites A, B, and C are stable in
alfalfa at -20 C for up to 24 months, in frozen (<0 C) apples,
blueberries, and sugarcane for up to 6 months, in frozen (<0 C)
mint for up to 18 months, and in frozen milk for up to 1 month.
Storage stability data on blueberries can be translated to
caneberries, peaches, and strawberries. The Agency has also
concluded that terbacil residues are stable in frozen asparagus and
grass (forage, fodder, and hay) for up to 18 months based upon
storage stability data translated from alfalfa and mint.
(7) Magnitude of the Residue in Crop Plants
For purposes of reregistration, requirements for magnitude
of the residue in plants are fulfilled for the following crops: alfalfa,
apples, asparagus, blueberries, caneberries, grass (grown for seed),
mint, peaches, and sugarcane. Adequate field trial data depicting
terbacil residues following applications made according to the
maximum or proposed use patterns have been submitted for these
commodities. Geographical representation is adequate and a
sufficient number of trials were conducted.
(8) Magnitude of the Residue in Processed Food/Feed
The reregistration requirements for magnitude of the residue
in processed food/feed commodities are fulfilled for apple and mint.
Based on these studies, tolerances are not required on apple and
mint processed commodities.
Data are required depicting the potential for concentration
of terbacil and its metabolites in blackstrap molasses processed from
sugarcane bearing detectable terbacil residues.
17
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As the use on citrus fruits has been deleted from the label,
the requirement for a citrus processing study is no longer
applicable.
(9) Magnitude of the Residue in Meat, Milk, Poultry, and
Eggs
The requirement for a poultry feeding study has been waived
because the Agency has determined there is no likelihood of finite
residues based upon the results of the poultry metabolism study
which used a 65x feeding level.
Currently alfalfa forage and hay are the only livestock feed
items having a registered use and established tolerances (the SLN
uses on grass grown for seed prohibit the grazing or feeding of
treated forage or hay to livestock—see "Directions for Use"
section). The Agency concludes that terbacil residues in ruminant
commodities show no likelihood of finite residues. The
requirement for a ruminant feeding study is waived and the
established animal tolerances should be revoked.
(10) Magnitude of the Residue in Water, Fish, and Irrigated
Crops
Presently, terbacil is not registered for direct use on potable
water and aquatic food and feed crops; therefore, no residue
chemistry data are required under this guideline topic.
(11) Magnitude of the Residue in Food-Handling
Establishments
Terbacil is not registered for use in food-handling
establishments; therefore, no residue chemistry data are required
under this guideline topic.
(12) Confined Accumulation in Rotational Crops
Data were' required depicting the nature of terbacil residues ,
in confined rotational crops. As a result of the aerobic soil
metabolism study reviewed, the Agency considers this guideline
fulfilled. ,
(13) Field Accumulation in Rotational Crops
Since the limited rotational field trials indicated that residues
of concern can potentially be present in rotated crops planted at the
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labeled 2ryear plant-back interval at levels > 0.01 ppm, then
extensive field rotational crop studies could be required. The
Agency will instead require that these additional limited rotational
studies be performed with crops to which rotations are likely (corn,
and soybean). If residues of concern appear in these rotated crops,
then establishment of rotational crop tolerances will be required.
b. Dietary Exposure (Drinking Water Sources) <
(1) Ground water
(a) Acute Exposure
Using the Ground Water Interactive Concentration
(GWIC) screening model, the concentration of terbacil in
shallow groundwater is not expected to exceed 125 fig/L for
most uses. There are a number of uncertainties with this
model, including that the predicted ground water
concentrations are linearly extrapolated from the application
rate, with no consideration of hydrology, soil properties,
climatic conditions, agronomic practices, or volatilization.
For this reason, the estimated GWIC value from this model
can be used as an upper bound for the acute ground water
exposure assessment calculations.
If the maximum estimated GWIC level (125 ^g/L or
0.125 mg/L) is assumed, acute exposure from the ingestion
of terbacM-contaminated ground water can be calculated for
the most sensitive sub-population (60 kg female, age 13+
years) as follows:
For a 60 kilogram female, consuming 2 Liters per day
Exposure = (0.125 mg/L x 2 L/day) -5- 60 kg = 0.004
mg/kg/day
(b) Chronic Exposure
The EPA Pesticides hi Ground Water Database (EPA
734-12-92-001, September 1992) reports only 6 detects of
terbacil (ranging from 0.3 to 8.9 ^g/L) out of 288 wells
tested hi six states (i.e., California, Louisiana, Mississippi,
Oregon, Washington, and West Virginia). One reason for
v low frequency of detections of terbacil in some of the
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available ground water surveys is high minimum detection
limits. In most of the state surveys, terbacil minimum
detection limits have been 5 to 100 times higher (i.e., less
sensitive) than detection limits that have been achieved in
recent surveys for most widely used herbicides. Another
reason why terbacil should not be detected frequently in
general ground water surveys is because only a small
percentage of the overall agricultural acreage in the United
States is treated with terbacil in a given year.
While limited ground water data exist, they do give
some indication of the potential presence of terbacil in
drinking water sources, and are therefore used as
representative of actual ground water concentrations in the
chronic exposure calculations below.
' If the maximum detected level (8.9 peg/Lor 0.0089
mg/L) is assumed, chronic exposure from the ingestion of
terbacil-contaminated ground water can be calculated for the
general U.S. population and for children, as follows:
For the U.S population:
Exposure (mg/kg/day) = (0.0089 mg/L x 2 L/day) / 70 kg
= 0.00025 mg/kg/day
For a 10-kilogram child, consuming 1 Liter per day
Exposure (mg/kg/day) = (0.0089 mg/L x 1 L/day)/ 10 kg
= 0.00089 mg/kg/day
(2) Surface Water
Two environmental concentration models were used to
estimate exposure to terbacil via ingestion of surface water: a tier
one model named, GENEEC (GENeric Expected Environmental
Concentration), and a tier two model named, PRZM 2.3. Risk
calculations for surface water appear later in this section.
(a) Acute Exposure
i
GENEEC estimates expected concentrations from a
few basic chemical parameters and pesticide label
application information. GENEEC uses a chemical's
soil/water partition coefficient and degradation half-life
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values to estimate runoff from a ten-hectare agricultural
field into a one-hectare by two-meter-deep pond. GENEEC
considers reduction in dissolved pesticide concentration due
to adsorption of pesticide to soil or sediment, incorporation,
degradation in soil before wash off to a water body, direct
deposition of spray drift into the water body, and
degradation of the pesticide within the water body.
GENEEC was designed for use in ecological risk-
assessment and, therefore, it could substantially over-
estimate the actual drinking water concentrations. Because
of its conservative values, output from this model is used in
the acute exposure calculations below.
The GENEEC model gives the peak Estimated
Environmental Concentrations (EEC) of terbacil in surface
water as 0.154 ppm (0.154 mg/L). Using this value, acute
exposure from ingestion.of terbacil-contaminated surface
water can be calculated for the most sensitive subpopulation
(females, 13+years) as follows: ,
Exposure = (0.154 mg/L x 2 L/day) / (60 kg) = 0.005
mg/kg/day
(b) Chronic Exposure
PRZM 2.3, linked with a program named, EXAMS,
models pesticide concentrations in surface water associated
with usage on a given crop, in a given geographical
location. Soil and hydrologic input parameters are used,
and dissipation is projected on a yearly basis, over the
period 1948 through 1983. Volatilization, soil binding and
photodegradation predictions are used to calculate
dissipation rates. Risk calculations for chronic exposure to
terbacil-contaminated surface drinking water that appear
later in this chapter, are based on the output from the
PRZM/EXAMS model because it represents a more refined
upper bound estimate of concentrations of terbacil in surface
water than GENEEC.
PRZM/EXAMS, like GENEEC, also may
overestimate concentrations of pesticides in drinking water.
This model uses input parameters and assumptions that
represent worst case scenarios. For example,
PRZM/EXAMS models a static pond system, where
21
-------
dissipation from outflow and aerobic aquatic metabolism are
not factored in, nor is any other active degradation process
other than photodegradation. Because of the static nature
of the model, yearly concentration estimates increase with
each successive year due to accumulation. The Agency
determined the average annual incremental increases in
predicted surface water terbacil concentrations due to this
accumulation factor, for the major crop uses, e.g.,
Louisiana sugarcane (36 pig/L) and New York apples (4
For the purpose of calculating chronic exposure to
terbacil-contaminated surface drinking water, the Agency
.has chosen to use a value from analysis of the 36-year
period of terbacil use on sugarcane because this end-use
resulted in the highest predicted concentrations. The last
year of the model's 36-year analysis of sugarcane reflects
the accumulation of terbacil at an average incremental
increase of 36 jtg/L/year. The Agency believes that a more
reasonable and representative value to use is the value for
the first year of the analysis. This value is conservative
because of all the previously mentioned conservative input
parameters, and because it comes from the highest end-use
values. However, it does not incorporate the 36 /tg/L
annual accumulation factor which is unlikely to be seen in
an open system. (It should be noted that STORET data also
suggest that terbacil is not accumulating in surface water.)
The PRZM/EXAMS model gives the maximum EEC
for the first year of the 36-year sugarcane analysis as 105
Atg/L (105 ppb). Using this value, chronic exposure from
ingesting terbacil-contaminated surface drinking water can
be calculated as follows:
For the U.S population:
Exposure (mg/kg/day) = (0.105 mg/L x 2 L/day) / 70 kg
= 0.003 mg/kg/day
For a 10-kilogram child, consuming 1 Liter .per day
* \
Exposure(mg/kg/day) = (0.105 mg/L x 1 L/day) / 10 kg
= 0.0105 mg/kg/day
22
-------
4. Dietary Risk Assessment
-• / - .
a. Toxicologic Endpoints
The Reference Dose (RfD) used in the analysis is 0.013 mg/kg
bwt/day, based on a NOEL of 1.25 mg/kg bwt/day (and an uncertainty
factor of 100) from a two-year feeding study in dogs that demonstrated
increased relative liver weights, increased thyroid : body weight ratio and
elevated alkaline phosphatase as endpoints.
Terbacil is classified as a Group E carcinogen.
The endpoint for acute dietary risk assessment is a developmental
toxiciry NOEL of 12.5 mg/kg bwt/day from a dietary study in rats, based
upon a significantly decreased number of live fetuses per litter at the LOEL
of 62.5 mg/kg bwt/day.
b. Residue Information
Tolerances for residues of terbacil are expressed in terms of
terbacil per se in/on apples, pears and sugarcane and published in 40 CFR
§180.209(a). For other plant and animal commodities, tolerances are
currently expressed as the combined residues of terbacil and its metabolites
, A, B, and C in 40 CFR §180.209(b). No food/feed additive tolerances
have been established for residues of terbacil.
/ ,
c. Chronic Exposure/Risk (TMRC)
A DRES chronic exposure analysis was performed using tolerance
level residues and a 100 percent crop treated assumption to estimate the
Theoretical Maximum Residue Contribution (TMRC) for the general
population and 22 subgroups. No anticipated residue (AR) information
was used in this analysis.
Existing tolerances result in a TMRC which represents 12.2 % of the
RfD for the U.S. general population. The highest subgroup, Non-Nursing
Infants (< 1 year old) occupies 62.3% of the RfD.
Incorporating the recommendations of the Agency (i.e., to xevoke
tolerances for citrus fruits and pears, and to raise tolerances on caneberries,
blueberries, peaches, apples and sugarcane), results in a TMRC which
represents 4.5% of the RfD for the U.S. general population.. For the
highest subgroup, Non-Nursing Infants (< 1 year old), 24.6% of the RfD
is occupied. .
23
-------
The analysis for terbacil is a worst case estimate of dietary exposure
with all residues at tolerance level and 100 percent of the commodities
assumed to be treated with terbacil. For both existing published tolerances
and incorporating the changes recommended by the Agency, it appears that
chronic dietary risk from the uses supported in reregistration, is not of
concern.
d. Acute Exposure/Dietary Risk
Two acute analyses were performed showing results from all
presently registered commodities and results following the
recommendations of the Agency.
The Margin of Exposure (MOE) is a measure of how close the high
end exposure comes to the NOEL (the highest dose at which no effects
were observed in the laboratory test), and is calculated as the ratio of the
NOEL to the exposure (NOEL/exposure = MOE). Generally, acute
dietary margins of exposure greater than 100 tend to cause no dietary
concern. Because the endpoint of concern was a developmental effect, the
only sub-population of concern is females of child bearing age (i.e.,
females, 13+ years old). The NOEL used in the calculation is from an
animal study. In determining the high end exposure values below, the
formula includes the relative dose value (RDV), which is a code chosen to
cause the DRES model to create an appropriate spreadsheet of estimated
values.
Presently registered commodities result in a MOE for Females (13+
years) of 3125
High End Exposure = RDVxX
= 0.001 x 4
= 0.004
MOE = NOEL + Exposure
MOE = 12.5 mg/kg/day + 0.004 mg/kg/day. = 3125
Following the recommendations of the Agency results in a MOE of
terbacil for Females (13+ years) of 4166
High End Exposure = RDV x X
= 0.001 x 3
= 0.003 ;
MOE = NOEL -s- Exposure
24
-------
MOE = 12.5 mg/kg/day -s- 0.003 mg/kg/day = 4166
The MOE values demonstrate that there is no cause for concern regarding
the acute dietary exposure from terbacil for existing uses.
e. Drinking Water Risk (Ground Water)
(1) Acute Risk
The highest concentration of terbacil in shallow groundwater
• predicted by the Ground Water Interactive Concentration (GWIC)
: screening model (0. 125 mg/kg/day), results in an acute exposure of
0.004 mg/kg/day. Using this value, acute risk from ingestion of
terbacil-contaminated ground water, expressed as the Margin of
Exposure (MOE), can be calculated for the most sensitive sub-
population as follows:
For a female (13+ years'), weighing 60 kg. and ingesting 2 liters
per day: '
MOE = (NOEL)/(Exposure)
MOE = (12.5 mg/kg/day) / (0.004 mg/kg/day) = 3100
(2) Chronic Risk
Chronic exposure levels had previously been derived by
using the maximum detected terbacil level (0.0089 mg/L) in EPA's
Ground Water Database. Using these values^ chronic risk from the
ingestion of terbacil-contaminated ground water can be calculated
for the general U.S. population and for children, as follows:
For the U.S. population:
% RfD = (Exposure + RfD) (100)
% RfD = (0.00025 + 0.013) (100) = 2 %
For a 10-kg child: .
%RfD = (Exposure + RfD) x 100
%RfD = (0.00089 mg/kg/day * 0.013 mg/kg/day) x 100 = 7
f. Drinking Water Risk (Surface Water - Acute)
The estimate of acute exposure derived from the GENEEC model's
peak EEC of terbacil in surface water is 0.005 mg/kg/day. Using this
' - • • ' . 25 -.".'•
-------
value, acute risk from ingestion of terbacil-contaminated surface water,
expressed as the Margin of Exposure (MOE), can be calculated for the
most sensitive sub-population as follows:
For a female (13+ years), weighing 60 kg. and ingesting 2 liters
per day:
MOE = (NOEL)/(Exposure)
MOE = (12.5 mg/kg/day) / (0.005 mg/kg/day) = 2500
g. Drinking Water Risk (Surface Water - Chronic)
A chronic surface drinking water exposure value for terbacil was
derived from the first year annual maximum EEC from the
PRZM/EXAMS model for terbacil use on sugarcane. Using this estimated
. value, the upper bound chronic risk from ingesting terbacil-contaminated
surface water (expressed as %RfD) is calculated as follows:
For the U.S. population:
% RfD = (Exposure -s- RfD) (100)
% RfD = (0.003 + 0.013) (100) = 23 %
For a 10-kg child:
%RfD = (Exposure -s- RfD) x 100 - . .
%RfD = (0.0105 mg/kg/day -s- 0.013 mg/kg/day) x 100 = 81 %
In summary, the Agency usually has no concerns when less than
100% of the RfD has been used. Even using upper bound estimates, none
of drinking water scenarios analyzed abpve exceeds 100% of the RfD.
Because of this, and the fact that actual ground water monitoring data,
although limited, are not showing large amounts of terbacil present, the
Agency does not believe that drinking water sources of terbacil are of
concern.
5. Occupational Exposure and Risk Assessment
An occupational exposure assessment is required for an active ingredient
if (1) certain lexicological criteria are triggered and (2) there is potential exposure
to handlers (mixers, loaders, applicators, etc.) during use or to persons entering
treated sites after application is complete. The Toxicity Endpoint Selection
Committee found that neither dermal nor inhalation toxicity criteria were triggered
26
-------
for terbacil. Therefore, no assessments are needed for occupational exposure/risk
at this time.
a. Summary of Use Patterns and Formulations
Terbacil, 3-tert-butyl-5-cMoro-6-methyluracil, is a herbicide
formulated as a wettable powder (20 percent a.i.). Terbacil is used on
terrestrial food/feed crops (apples, mint/peppermint/spearmint, and
sugarcane), terrestrial food (asparagus, blackberry, boysenberry,
dewberry, loganberry, peach, raspberry, youngberry, and strawberry),
terrestrial feed (alfalfa, forage, and hay) and on forest trees (cottonwood).
Terbacil can be applied by aircraft and ground equipment (band treatment,
broadcast, direct sprays). The maximum application rates range from
0.264 to 3.2 LB a.i./acre, with the-lower rates generally usfed on coarse
textured soils and higher rates on fine textured soils.
b. Occupational-use products and homeowner-use products
At this time products containing terbacil are intended primarily for
occupational uses and are not registered for residential use, thus eliminating
concern for homeowner exposure.
c. Additional Occupational Exposure Studies
Data on worker exposures to terbacil have not been submitted to the
Agency. However, worker exposure studies are not required at this time
since there are no lexicological endpoints of occupational concern identified
for terbacil.
6. Food Quality Protection Act Considerations
a. Potential Risks to Infants and Children
EPA uses a weight of evidence approach in determining whether an
additional uncertainty factor is or is not appropriate for assessing risks to
infants and children; taking into account the completeness and adequacy of
the toxicity data base, the nature and severity of the effects observed in pre-
and post-natal studies, and other information such as epidemiological data.
For purposes of assessing the pre- and post-natal toxicity of terbacil,
EPA has evaluated two developmental studies and one reproduction study.
Based on current lexicological data requirements, .the data base for terbacil
relative to pre- and post-natal toxicity is complete. However, as EPA fully
implements .the requirements of FQPA, additional data related to the special
sensitivity of infants and children may be required.
27 :
-------
(1) Developmental and Reproductive Effects
(a) Developmental Toxicity
In the rat developmental toxicity study, the
developmental NOEL was 250 ppm (12.5 mg/kg/day); the
developmental LOEL of 1250 ppm (62.5 mg/kg/day) was
based upon significantly decreased number of live fetuses
per litter, apparently due to fetal loss occurring before or
near the time of implantation. The maternal NOEL was 250
ppm (12.5 mg/kg/day), based on decreased body weight at
1,250 ppm (62.5 mg/kg/day).
In the rabbit developmental toxicity study, the
maternal NOEL was 200 mg/kg/day, based on maternal
deaths (5 died and 2 were sacrificed in extremist at the
LOEL of 600 mg/kg/day. The developmental NOEL was
also 200 mg/kg/day based on decreased live fetal weights in
the high dose group (i.e., 600 mg/kg/day).
(b) Reproductive Toxicity
In a multigenerational reproductive toxicity study
with rats, the systemic NOEL of < 50 ppm (2.5
mg/kg/day) was based on the reduction of body weight gain
in males. The NOEL for reproductive toxicity was > 250
ppm (12.5 mg/kg/day).
(2) Uncertainty Factor
Because the developmental NOELs were the same as those
for maternal toxicity, and the NOEL for systemic (parental) toxicity
was higher than the NOEL for reproductive toxicity, these data do
not suggest an increased pre- or post-natal sensitivity of children
and infants to terbacil exposure. Therefore, the Agency concludes
that the available toxicology data do not support an uncertainty
factor of 1000 as specified in FQPA and that the present uncertainty
factor of 100 is adequate to ensure the protection of infants and
children from exposure to terbacil.
(3) Aggregate Exposure/Risk
Products containing terbacil are not registered for residential
use at this time. With regard to occupational risk, no dermal or
28
-------
inhalation endpoints of concern were identified and an assessment
is not needed. Therefore, the following aggregate risk
determinations are for dietary exposures only (from food and
water).
(4) Total dietary (food source and drinking water)
, Food source data are taken from the DRES Tables.
Drinking water figures are taken from calculations presented in
sections 4 f. and g. above.
Determination of Safety for U.S. Population rGhronicV
Aggregate Exposure = %RfD (food sources) + %RfD (surface
drinking water) ,
= 4.6% + 23%
= 27.6%
For 10-kg children (I to 6 years')
Aggregate Exposure = %RfD (food sources) + %RfD (surface
drinking water)
= 12.8% + 81%
= 93.8%
For females (13+ years old")
Aggregate Exposure = dietary exposure + drinking water
exposure '
= 0.003 mg/kg/day + 0.005 mg/kg/day
= 0.008 mg/kg/day
Aggregate MOE = NOEL + Aggregate Exposure
= 12.5 mg/kg/day + 0.008 mg/kg/day
= 1563
Conclusions: ,
Aggregate exposure/risk values are all below the level of
Agency concern. This includes the acute exposure of females of
child-bearing age.
29
-------
b.
Cumulative Effects
In assessing the potential risk from cumulative effects of terbacil
and other chemical substances, the Agency has considered structural
similarities that, exist between terbacil and other substituted uracil
compounds such as bromacil and lentacil.
A comparison of the available lexicological database for terbacil and
bromacil revealed no clear common mode of toxicity these chemicals. The
toxicology database for lentacil was not considered because there are
currently no registered uses of lentacil. A summary of the most prominent
clinical signs from terbacil and bromacil follows.
The following clinical signs were observed in the terbacil toxicology
database: decrease in body weight, increase in liver weights, vacuolization
and hypertrophy of hepatocytes, hypertrophy of centrilobular hepatocytes
in males, decreased pituitary weights in males and females, increase in
thyroid/body weight ratio, elevated alkaline phosphatase.
The following clinical signs were observed in the bromacil
toxicology database: decreased body weight, focal atrophy of seminiferous
tubules (testicular abnormalities), hydronephrosis, suggestive histological
evidence for antithyroid activity (cystic follicles in the thyroid and
enlargement of centrilobular cells of the liver) and a positive trend in
thyroid tumors for male rats (basis of C classification for carcinogenicity).
Based on these data, the Agency has determined that there is no
clear common mode of toxicity (thyroid or liver) between terbacil and
bromacil. With both chemicals, there is marginal evidence of liver effects
(principally enlargement of centrilobular cells). Enlargement of liver cells
is not a specific enough effect to be considered a common mode of toxicity.
The thyroid effects observed with bromacil were cystic follicles. Terbacil
induced an increase in relative thyroid weights but no increase in absolute
thyroid weights. An increase in relative weight without a corresponding
increase in absolute weight has very little meaning, especially without any
supporting histological or hormonal evidence. This conclusion was based
on the marginal liver effects noted in the databases, and .the absence of
thyroid effects in the terbacil database (with the exception of increases in
relative thyroid weights).
EPA has found no information indicating that any other chemical
has a common mode of toxicity with terbacil. Therefore, aggregate risk
assessment will indicate risks resulting only from terbacil.
30
-------
C. Environmental Assessment
1. Ecological Toxicity Data
All ecological toxicity data are fulfilled except for chronic avian and aquatic
toxicity studies (71-4 Avian Reproduction Study; 72-4 Fish Early Life Stage and
Aquatic Invertebrate Life Cycle). These data are-needed because terbacil is a
persistent compound which may pose long-term exposure in terrestrial and aquatic
environments. Wild mammal toxicity study (71-3) is reserved pending the results
of avian reproduction studies (71-4).
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
An acute oral toxicity study using the technical grade of the
active ingredient (TGAI) is required to establish the toxicity of
terbacil to birds. The preferred test species is either mallard duck
,. • .(a waterfowl) or bobwhite quail (an upland gamebird). Results of
this test are tabulated in Table 5 below.
Table 5: Avian Acute Oral Toxicity
Species
Northern bobwhite quail
(Colinus virg inianus)
%s.i>
96.1
£*>so
C»B/kg)
i>2250
Toxfc% Category
Practically non-toxic
MSBONo.
Author/Year
ace. 157177
Beavers, 1986
Sfcidy
Classification1
Core
Terbacil is practically non-toxic to avian species on an acute
oral basis. The guideline (71-1) is fulfilled. (Accession # 157177).
Two subacute dietary studies using the TGAI are required to
establish the toxicity of Terbacil to birds. The preferred test
species are mallard duck and bobwhite quail. Results of these tests
are tabulated in Table 6 below..
Table 6: Avian Subacute Dietary Toxicity
Species
Peking mallard
Pheasant
Mallard duck
(Anas platyrhynchos)
.,-%aJL
80 WP
80 WP
96
S-BayJLC^
tepmj
> 56,200
26,4262
>50003
Toxicity
Category
practically
non-toxic
practically
non-toxic ,
practically
non^-toxic
MXOD No, Author/Year
00012347 Wazeter, 1966
00012346 Wazeter, 1966
ace. 241 146 Moore, 1979
Study ,
Classification1
supplemental
(formulated product)
supplemental
(formulated product)
core
> " v — ^^ f fXT —--——"—— ^»*-»-—:j **f u««^«^L&MuijL«^ujL«.jr '7*>.**r*iisjj L/ui KM^^o UUL ouUoJ.V c£illUwJJXlC«
It is unclear if the reported concentration is based on the formulated product or on .active ingredient. The number
corrected for percent active (80%) would be 21,141 ppm.
3No mortality was observed at the 5000 ppm concentration.
31
-------
Terbacil is practically non-toxic to aviah species on a
subacute dietary basis. The guideline (71-2) is fulfilled (MRID
00012347, 00012346, Ace. 241146).
(2) Birds, Chronic
Avian reproduction studies using the TGAI are required for
terbacil because the birds may be subject to repeated or continuous
exposure to terbacil due to the persistence, especially preceding or
during the breeding season. The preferred test species are mallard
duck and bobwhite quail. There are, currently, no data from avian
reproduction studies. These studies are outstanding. The 71-4
Avian Reproduction data requirement is not fulfilled.
(3) Mammals
Wild mammal testing is required on a case-by-case basis,
depending on the results of lower tier laboratory mammalian
studies, intended use pattern and pertinent environmental fate
characteristics. In most cases, rat or mouse toxicity values obtained
from the Agency's Health Effects Division (HED) substitute for
wild mammal testing. These toxicity values are reported in Table
7 below.
Table 7: Mammalian Toxicity
Species/
Study Duration
Rat(Rattus
norvegicus)
Rat
% I
44.
80
80
Test
(type
Acute oral
3-generation
rat study
Toxicity
Value
LDSO>5,000
mg/kg
NOEL> 250
ppm
Affected Endpoints
none
The NOEL for reproductive toxicity
was > 250 ppm (12.5 mg/kg)
MRJJJNo.
Ace. #114693
and 24955
Ace. No.
249455
The results indicate that terbacil is practically non-toxic to small
mammals on an acute oral basis.
(4) Insects
A honey bee acute contact study using the TGAI is required
for terbacil because its use (apple, alfalfa, peach, caneberry,
strawberry, mint, and sugarcane) will result in honey bee exposure.
Results of this test are tabulated in Table 8 below.
32
-------
Table 8; Nontarget Insect Acute Contact Toxicity
Species •.
Honey bee
(Apis meUifera)
%a.t«
80 WP
UV
<#g/)bee)
193
Tori<% Category
practically non-toxic
MBIDKo.
Author/Year
00018842
Atkins, 1969
Study
Classification
core
The results indicate that terbacil is practically non-toxic to
bees on an acute contact basis; The guideline (141-1) is fulfilled
(MRID 00018842).
b. Toxicity to Aquatic Animals
w ,
(1) Freshwater Fish, Acute
Two freshwater fish toxicity studies using the TGAI are
required to establish the toxicity of terbacil to fish. The preferred
test species are rainbow trout (a coldwater fish) and bluegill sunfish
(a warmwater fish). Results of these tests are tabulated in Table 9
below.
Table 9; Freshwater Fish Acute Toxicity
Species (all of testing
below are Static)
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Rainbow trout
(Oncorhynchus mykiss)
Rainbow trout
(Oncorhynchus mykiss)
Carp (48 hr.)
Japanese Goldfish (48 hr.)
Killifish (48 hr.)
Loach (48 hr.)
%a.i*
96.6
96.6
80
80
80
80
80
964t0nr:LC.p
(ppm) (nominal)
46.2
102.9
112
79
54
96
>40
Ttaddty
Category
slightly toxic
practically
non-toxic
practically
non-toxic
slightly toxic
slightly toxic
slightly toxic
slightly toxic
MRID No.
Author/Year
00390017
Smith, 1980
00390019
Summers, 1978
00025224
McCann, 1972
00025223
McCann, 1972
44150201
McCann, 1972
ace. 249455
Yoshida, 1972
ace. 249455
Yoshida, 1972
Study Classification
core
core
core,
(formulated product)
core,
(formulated product)
core,
(formulated product)
supplemental
supplemental
Since the LC50 falls in the range of 40 - 100 ppm, terbacil
ranges from slightly to practically non-toxic to freshwater fish on
an acute basis. The guideline (72-1) is fulfilled (MRID 00390017,
00390019, 00025223, 00025224, 44150201, acc.#249455).
33
-------
(2) Freshwater Fish, Chronic
A freshwater fish early life-stage test using the TGAI is
required for terbacil because the end-use product is very persistent
in the aquatic environment. There are currently no data for
assessing chronic effects to freshwater fish. A freshwater fish early
life-stage test using the TGAI is outstanding. The preferred test
species is rainbow trout. The guideline is not fulfilled.
(3) Freshwater Invertebrates, Acute
*
A freshwater aquatic invertebrate toxicity test using the
TGAI is required to establish the toxicity of terbacil to aquatic
invertebrates. The preferred test species is Daphnia magna.
Results of this test are tabulated in Table 10 below.
Table 10; Freshwater Invertebrate Acute Toxicity
Species (all of testing
below are Static)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
% a.l .
95
not
stated
not
stated
48-fcourECsj
i (ppm) (nominal]
65
68
63
Toxieity Category
slightly toxic
slightly toxic
slightly toxic
MRIDHo,
Author/Year
00390018
McCann, 1981
acc.#249455
Hall, 1981
acc.#125705
Phillips, 1981
Sftt4y
Classification
core
supplemental
supplemental
Since the ECSO falls in the range of 10-100 ppm, terbacil is
slightly toxic to aquatic invertebrates on an acute basis. The
guideline (72-2) is fulfilled (MRID 00390018, accession #249455,
accession #125705).
(4) Freshwater Invertebrates, Chronic
A freshwater aquatic invertebrate life-cycle test using the
TGAI is required for terbacil since the end-use product is intended
for use such that its presence in water is likely to be continuous or
recurrent because of the persistence of terbacil. The preferred test
species is Daphnia magna. Currently, there are no data available
from this study and it is currently outstanding. The guideline is not
fulfilled.
(5) Estuarine and Marine Fish, Acute
Acute .toxicity testing with estuarine/marine invertebrates
using the TGAI is required for terbacil because the end-use product
34
-------
is intended for application sites near coastal counties such as apple,
forestry, and alfalfa. The preferred test species is sheepshead
minnow. Results of these tests are tabulated in Table 10 below.
Table 10: Estuarine/Marine Fish Acute Toxicity
Species
Sheepshead minnow
(Cyprinodon variegatus)
iT^ ; ; '- :
%*A.
• 97.4
M-liotir
tCjo (gpm a ju)
108.5 (measured)1
Toxicity
Oategojcy
practically
non-toxic
MKBDNo.
Author/Year ,
41896100
Ward, 1990
Study
Classification
core
Test was conducted under static conditions.
Terbacil is practically non-toxic to estuarine/marine fish on
an acute basis. The guideline (72-3(a)) is fulfilled (MRID
41896100).
(6) Estuarine and Marine Fish, Chronic
An estuarine/marine fish early life-stage toxicity test using
the TGAI is reserved pending results of the freshwater fish early
life-stage toxicity test.
(7) Estuarine and Marine Invertebrates, Acute
Acute toxicity testing with estuarine/marine invertebrates
using the TGAI is required for terbacil because the end-use product
is intended for application near coastal counties such as apple,
forestry, and alfalfa. The preferred test species are mysid shrimp
and eastern oyster. Results of these tests are tabulated in Table 10
below.
Table10: Estuarine/Marine Invertebrate Acute Toxicity
Species (all tested under
static conditions)
Eastern oyster (embryo-larvae)
(Crassostrea virginica)
Fiddler crab
Grass shrimp
%alf*
84.7
84.7
84,7
Stf-aour LCgd/EC^
(ppma.y (nominal)
>4.9 (48 hr.)
>1000
56.4
Toxicity
Category ,
moderately
toxic
practically
non-toxic
slightly
toxic
MRID No.
Atithor/Year
00012333
Benfley, 1973
00012332
Benfley, 1973
00012332
Benfley, 1973
Study
Classification
core1
supplemental
core
This study was made core because the ECC was not expected to exceed 4.15 ppm a.i..
Terbacil ranges from moderately toxic to practically non-
toxic to estuarine/marine invertebrates on an acute basis. The
35
-------
guideline (72-3(b) and 72-3(c)) is fulfilled (MRID 00012332,
00012333).
(8) Estuarine and Marine Invertebrate, Chronic
An estuarine/marine invertebrate life cycle toxicity test using
the TGAI is reserved pending results from freshwater aquatic
invertebrate life cycle toxicity test.
c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative
vigor) is required because terbacil has terrestrial non-residential
outdoor use patterns and it may move off the application site
through spray drift or runoff. For seedling emergence and
vegetative vigor testing the following plant species and groups
should be tested: (1) six species of at least four dicotyledonous
. families, one species of which is soybean (Glytine max), and the
second of which is a root crop, and (2) four species of at least two
monocotyledonous families, one of which is corn (Zea mays).
Terrestrial Tier II studies are required for all low dose
herbicides (those with the maximum use rate of 0.5 Ibs a.i./A or
less) and any pesticide showing a negative response equal to or
greater than 25% in Tier I tests. Tier n tests measure the response
of plants, relative to a control, and five or more test concentrations.
Results of Tier n toxicity testing on the technical/TEP material are
tabulated in Table 11 below.
36
-------
Table 11: Nontarget Terrestrial Plant Seedling Emergence Toxicitv (Tier ID
Species
Monocot- Corn
Monocot- onion
Monocot- sorghum
Monocot- wheat
Dicot- cucumber
Dicot- pea
Dicot- rape
Dicot- soybean
Dicot- sugar beet
Dicot- tomato
Monocot - wheat
Monocot- corn
Monocot- sorghum
Dicot- sugar beet
Dicot - pea
Dicot- soybean
Dicot- tomato
Dicot- rape
Dicot- cucumber.
&«JU
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
BCjs
(Ib a.i./A>
0.0622
0.0286
0.0913
0.0299
0.0736 '
0.1173
0.0149
0.0963
0.0192
0.0180
0.0250
0.6600 '
0.1100
0.0270
17.0
15.0
0.016
0.013
0.045
EC^ Endpoiat
Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry. weight
dry weight
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
EC^/NOEC
OB*a.iJA>
0.0250
0.0125
0.0500
0.0125
0.0500
0.0286
0.0063
0.0500
0.0125
0.0125
0.0310
0.0310
0.0620
0.0150
0.5000
4.0
0.0070
0.0070
0.0070
BcyNoae
Endpoint Affected
dry weight
dry weight
dry weight
dry weight
dry weight ,
dry weight
dry weight
dry weight
dry weight
dry weight
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
MRID,Ne.%
Author/Vear
43895801
Heldrem, 1996
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
McKelvey, 1992
42336701
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
Species was upgraded; to core since EPA now accepts thiram and captan seed treatments in the testing protocol.
Study
Classification
core ,
core
core
core
core
core
core
core
core
core
core
core1
core
core
core1 !
core
core
core
core1
For Tier n seedling emergence, rape is the most sensitive
dicot (EC25= 0.013 Ib a.i./A). Wheat is the most sensitive
monocot (EC25= 0.0299 Ib a.i./A). The guideline (123-l(a)) is
fulfilled (MRID 43895801, 42336701).
37
-------
Table 12: Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier IT)
Species
Monocot- Com
Monocot- onion
Monocot- sorghum
Monocot-Wheat
Dicot- cucumber
Dicot- pea
Dicot- rape
Dicot- soybean
Dicot- sugar beet
Dicot- tomato
Monocot - wheat
Monocot- corn
Monocot- onion
Monocot- sorghum
Dicot- sugar beet
Dicot- cucumber
Dicot- pea
Dicot- soybean
Dicot- tomato
Dicot- rape
%
aX
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
EC*
0b a.i^A)
0.0297
0.0741
0.0426
0.0087
0.0058
0.0357
0.0048
0.0108
0.0176
0.0126
0.0621
>2.0
0.12
>2.0
0.0008*
0.0022
l.O4
0.0180
0.0110
0.0035
ECu EndpOint
Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight •
dry weight
dry weight
dry weight
shoot height
all parameters
shoot weight
all parameters
root weight
root weight "
shoot weight
shoot weight
root weight
total weight
ECas/KTOEC
a.i./A)
0.0250
0.0500
0.0500
0.0063
0.0031
0.0250
0.0031
0.0018
0.0063
0.0063
0.12
>2.0
0.12
>2.0
<0.00703
0.0070
0.01704
0.0150
0.0070
0.0070
MVNOEC
Ettdpoiat Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
shoot height
all parameters
shoot weight
all parameters
root weight
root weight
shoot weight
shoot weight
root weight
total weight
MRIDNo.
Author/Year
43895801
Heldreth, 1996
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
McKelvey, 1992
42336701
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
Study
Classification
core
core
core
core
core
core
core
core
core
core
core
core
core
core
supplemental
core
core
core
core
core
'The value is not statistically valijd.
'Species were upgraded to core since EPA now accepts thiram and captan seed treatments in the testing protocol.
'The results may not be accurate because they were obtained by extrapolating far outside the range of data.
''Positive rate response.
For Tier n vegetative vigor, cucumber is the most sensitive
dicot (EC25= 0.0022 Ib a.i./A). Wheat is the most sensitive
monocot (EC^ 0.0087 Ib a.i./A). The guideline (123-l(b)) is
fulfilled (MRID 43895801,42336701).
(2) Aquatic
Aquatic plant testing (tier IT) is required for terbacil because
it move off-site by runoff and by aerial spray drift. The following
species should be tested at Tier II: Kirchneria subcapitata
(Selenastrum capricomutum), Lemna gibba, Skeletonema costatum,
Anabaenaflos-aquae, and a freshwater diatom. Results of Tier n
toxicity testing on the technical/TEP material are tabulated in Tale
13 below.
38
-------
Table 13; Nontarget Aquatic Plant Toxicity (Tier D)
Species
%a.i.
EC*,
(ppma.i.)
•JSCWNOKC
(ppma.i.)
MSBEDN0W
Author/Year
Study
Classification
Vascular Plants
Duckweed Lemna gibba
96.44
0.140
0.065
43929801 Thompson, 1996
core
NEonvascBlar Plants ( , ,
Green algae
Kirchneria subcapitata
Marine diatom
Skeletonema costatum
Freshwater diatom
Navicula pellieulosa
Blue-green algae
Anabaena flos-aquae
97.4
96.44
96.9
96.44
0.018
0.140
0.011
0.120
v 0.004 '
0.081
0.007
0.06:2
42306101
Hoberg, 1990
43929802
Thompson, 1996
43909802
Hughes, 1996
43929802
Thompson, 1996
core
core
core
core
The Tier n results indicate that Navicula pellieulosa is the
most sensitive nonyascular aquatic plant. The guideline (123-2) is
fulfilled (MRID 43929802, 43909802, 42306101, 43929801).
2. Environmental Fate
i
All environmental fate data are fulfilled at this time. However, additional
information on aerobic aquatic metabolism (162-4) of terbacil is needed because
terbacil is likely to move into surface waters. These data will provide, a more
realistic assessment of terbacil concentration in surface waters.
a. Environmental Fate Assessment
Based on acceptable, supplemental, and ancillary environmental fate
data, terbacil dissipation appears to dependent on microbial-mediated
.degradation, photodegradation in water, and movement into ground and
surface waters. The relative importance of degradation and mobility in
controlling terbacil dissipation under actual use conditions cannot be fully
evaluated from the existing environmental fate data. However, the data
indicate that terbacil ,is very, persistent and potentially very mobile in
terrestrial environments. Compounds with similar environmental fate
behavior (e.g., bromacil) have been detected in ground and surface waters.
Terbacil is stable to abiotic hydrolysis and slowly degrades through
photolysis in natural and reference laboratory water samples (im= 29 to 54
days) and soil (t1/2=122 days). The photodegradation rate appears to be
dramatically enhanced by the presence of some photosensitizers (riboflavin
39
-------
and methylene blue). Major photodegradation transformation products
(>10% of applied) are . 5-chloro-6-methyluracil, 3-tert-butyl-6-
methyluracil, and 6-chloro-2,3-dihydro-3,3, 7-trimethyl-5H oxazolo (3,2-
a)-pyrimidine-5-one, tert-butyl-5-acetyl-5-hydroxyhydantoin (Compound
IT), 3-tert-butyl-5-hydroxyhydantoin (Compound HI), and 5-chloro-6-
methyl-(3l,5t)-5I-chloro-6l-methyl-5',6'-dihydro-6',2-anhydro-3t-tert-
butyluracilyluracil (Compound VI). Terbacil is persistent under aerobic
and anaerobic soil conditions (t1/2= 235 to 653 days). Minor nonvolatile
transformation products are t-butylurea and 3-t-butyl-5-chloro-6-
hydroxymethyuracil. The major volatile transformation product is CO2.
The reported laboratory degradation data indicate terbacil is persistent in
terrestrial environments.
Terbacil has a low sorption affinity to soil (1^=0.39 to 1.3 ml/g;
Koc= 44 to 61 ml/g). Therefore, terbacil is expected to be very mobile in
soil. Soil column studies also indicate that terbacil and its transformation
products can move through soil columns. Laboratory mobility studies
indicate terbacil and its transformation products are potentially mobile in
terrestrial environments.
Marginally acceptable field dissipation studies indicate terbacil, at
5 Ibs a.i./A, is persistent and mobile under actual use conditions. Field
dissipation half-lives in Delaware, Illinois, and California ranged from 204
to 252 days. The maximum depth of terbacil detection was 45 to 50 cm .
Ancillary field studies using plants as biological indicators also suggest'that
phytotoxic "terbacil residues" are persistent and mobile. Field dissipation
studies confirm that terbacil is persistent and potentially mobile under
actual use conditions.
Terbacil was bioaccumulated (< 8 jtig/g) in bluegill sunfish tissues
under static concentrations of 0.01 and 1.00>g/ml. Bioaccumulated
terbacil declined below the detection limit (<0.01 ^g/g) during a 3 day
depuration period. Terbacil is not expected to bioaccumulate in fish
tissues.
b. Environmental Fate and! Transport
(1) Degradation
(a) Abiotic Hydrolysis
Radiolabeled terbacil was stable (> 6 weeks) in pH
5, 7, and 9 buffer solutions in the dark at 25°C (Ace. No.
0001946). Ancillary data also indicate terbacil was stable
40
-------
in pH 4 to 10 buffer solutions at 25°C (Archer et d., 1981).
The hydrolysis (161-1) data requirement is fulfilled. No
additional hydrolysis data are needed at this time.
(b) Photodegradation in Water
Radiolabeled terbacil, under natural sunlight, had a
first-order photodegradation half-life of 29 days in standard
reference water, 37 days in Brandywine River Water, 54
days in the Brandywine River Water with suspended
sediment, and 3.25 days in reference water with a riboflavin
sensitizer (Rhodes, 1975). Under UV light from fluorescent
and black lights, radiplabeled terbacil had a first-order
photodegradation half-life of 44 days in standard reference
water, 82.91 days in Brandywine River Water, and 4.8
days in reference water with a riboflavin sensitizer. Major
photodegradation products (>10% of applied were 5-
chloro-6-methyluracil, 3-tert-butyl-6-methyluracil, and 6-
chloro-2,3-dihydro-3,3,7-trimethyl-5H oxazolo (3,2-a)-
pyrimidine-5-one. Radiolabeled terbacil, at 700 pg/ml,
under natural sunlight,had a first-order photodegradation
half-life of < 2 hours in non-buffered aqueous solutions (pH
3.4 to 9.2) containing methylene blue (3 /tg/ml) or
riboflavin (10 /ig/ml) photosensitizer (Archer, 1981).
Terbacil, at 250 ppm, was photolytically stable in non-
buffered aqueous solutions (pH 4-10) irradiated with a
mercury (Hg) vapor lamp at 25 °C. Rose bengal and
methylene blue were effective sensitizers in near- neutral to
alkaline non-buffered aqueous solution (pH > 6.6).
Riboflavin, at 10 /tg/ml, was an effective photosensitizer in
non buffered aqueous solutions (pH 4"to 10). Humic acid,
however, was not an effective sensitizer in aqueous
solutions. Major photodegradation products (>10% of
applied) were 3-tert-butyl-5-acetyl-5-hydroxyhydantoin
(Compound S), 3-tertrbutyl-5-hydroxyhydantoin
(Compound ID), and 5-cUoTo-6-m&±yl-(3',5")-5'-ctiioTO-6'-
methyl-5', 6' -dihydro-6', 2-anhydro-3' -tert-butyluracil
(Compound VT). Also, an unidentified photoproduct
(Compound V) was precipitated during photodegradation of
terbacil. Compound m, 3-tert-butyl-5-hydroxyhydantoin,
does not appear to be a photodegradate because it was
detected in dark controls. The Photodegradation in Water
(161-2) data requirement is fulfilled. No additional
photolysis in water data are needed at this time.
41
-------
(c) Photodegradation on Soil
Radiolabeled terbacil at 1.2 Ibs/A had an
extrapolated first-order degradation half-life of 61 days on
a Drummer silty clay loam when continuously irradiated for
15 days with a xenon arc lamp at 25°C (Accession No.
00160235). A corrected photodegradation half-life, based
on a 12 hour photoperiod, would theoretically be 122 days.
Radiolabeled terbacil was stable in the dark controls. The
degradation product, 5-chloro-6-methyluracil, was
detectable in both irradiated and dark control treatments.
However, unidentified radioactivity was detected in the
methanol soil extracts and non-extractable soil organic
matter.
In an ancillary study, radiolabeled terbacil had a
first-order degradation half-life of 46 days on a Keyport silt
loam when continuously irradiated with fluorescent
sunlamps and black light (1500 ptW/cm2) for 8 weeks
(Rhodes, 1975). Dark controls were not used in this study.
The major degradate (> 10% of applied) was 5-chloro-6-
methyluracil. •
The Photodegradation on Soil (161-3) data
requirement is fulfilled. No additional photodegradation on
soil data are needed at this time.
(d) Photodegradation in Air
The Photodegradation in Air (161-4) data
requirement is waived because terbacil has a low vapor
pressure (4.7 x 10"7 mm Hg at 29.5°C) and low Henry's
Constant (1.9 X 10'9 atm. nrVmole). The Photodegradation
in Air (161-4) data requirement is waived.
(e)
Aerobic Soil Metabolism
Radiolabeled terbacil, at 9.3 fig /g, had an
extrapolated, first-order half-life of 653 days in a Sassafras
sandy loam soil when incubated for 12 months at 25° C in
the dark (MRID 42369901). The major transformation
product (> 10% of applied) was 14C02. Minor
transformation products (< 10% of applied) were t-
butylurea and 3-tert-butyl-6-methyluracil. In an ancillary
study, radiolabeled terbacil had a half-life of 2 to 3 months
42
-------
in nonsterile soils (Fallsington sandy loam and Flanagan silt
loam) when incubated in a greenhouse (Rhodes, 1981).
Unacceptable aerobic soil metabolism data indicate
radiolabeled terbacil, at 4 jig a.i./g, had an extrapolated,
first-order half-life of 520 days in non-sterile silty clay: loam
soil when incubated for one year in the dark at 25°C (MRID
40253601). In sterile soil, terbacil had an extrapolated half-
life of 1007 days. Non-volatile, transformation products
were not identified; 14CO2 accounted for 9.7% of applied
terbacil.
Terbacil (Sinbar 80 WP), at 100 /tg/g, had an
estimated first-order half-life of 720 days in Triangle and
Boddington sandy loam soils (05013201; Marsh and Davis,
1978). Radiolabeled terbacil, at 4.5 Ibs a.i./A, had an
estimated first-order half-life of 32.5 days when incubated
in Keyport silt loam soil irradiated with 12 hoiir per day
photoperiod of UV light (mercury vapor light) for 6.5
.weeks (Rhodes, et al. 1969). The major degradate was
14CO2 (32% of applied radioactivity). Radiolabeled
terbacil, at 2.8 /*g/g, degraded to form 14CO2 (28 to 38% of
applied) in a Greenfield sandy loam soil unamended or
amended with plant residues with different carbon : nitrogen
ratios when incubated at 60% of field capacity at 22°C
(05024336, Wolf, D.A. Ph.D. dissertation; 05013204;
05016176, Wolf and Martin, 1974).
The Aerobic Soil Metabolism (162-1) data
requirement is fulfilled. No additional aerobic soil
metabolism data are needed at this time.
(f) Anaerobic Soil Metabolism
Radiolabeled terbacil,- at 9.3 jig/g, had an
extrapolated, first-order half-life of 235 days when
incubated for 90 days in anaerobic Sassafras sandy loam soil
at 25°C in the dark (MRID 42370001). Minor
transformation products (<10% of applied) were t-
butylurea and 3-tert-butyl-5-chloro-6-hydroxymethyluracil.
In an ancillary study, radiolabeled terbacil, at 2.1
jttg/g, had a half-life of > 60 days when incubated for 60
days in anaerobic mineral soils (Fallsington and Flanagan)
under greenhouse conditions (Rhodes, 1981). In an
43
-------
(2)
unacceptable study, radiolabeled terbacil, at 4 /*g/g, had an
extrapolated, first-order half-life of 178 days when
incubated in anaerobic silty clay loam soil in the dark at
25°C (MRID 40104701). Under sterile conditions,
radiolabeled terbacil was stable (t1/2 > 60 days).
Radiolabeled terbacil, at 2.8 /ig/g, did not degrade to form
14CO2 ( 0.2 % of applied) in Greenfield sandy loam soil
unamended or amended with plant residues with different
carbon: nitrogen ratios when' incubated under flooded
conditions at 22°C (05024336, Wolf, D.A. Ph.D.
dissertation; 05013204, Wolf, D.C., 1974.; 05016176,
Wolf and Martin, 1974). Terbacil (unspecified formulation),
at 8 /tg/g, degraded with a half-lives of 5 and 8 months in
a Chehalis loam soil at 31 °C and 13°C, respectively
(Zimdahl et al., 1970). Terbacil degradation was dependent
on first-order degradation kinetics.
The Anaerobic
requirement is fulfilled.
this time.
Soil Metabolism (162-1) data
No additional data are needed at
(g) Aerobic Aquatic Metabolism
Although the aerobic aquatic metabolism data are not
needed to support terrestrial uses of terbacil, environmental
fate properties of terbacil are similar to compounds
commonly detected in surface waters. Therefore, terbacil
is expected to move into surface waters from terrestrial use
sites. Aerobic aquatic metabolism data are needed to define
the rates and routes of terbacil dissipation in aquatic
environments. These data will be used to provide more
refined estimated environmental concentrations of terbacil
in surface water.
Mobility
(a) Batch equilibrium/soil column leaching
Radiolabeled terbacil, at 0.27 to 6.28 /tg/ml, had a
Freundlich adsorption coefficient of 0.39 ml/g (1^=61
ml/g; l/n=0.78) in Woodstown sandy loam, 0.71 ml/g
0^=58 ml/g; l/n=0.82) in Cecil sandy loam; 1.3 ml/g
(^=52 ml/g; l/n=0.90), 1.2 ml/g Q£ =44 ml/g;
l/n=0.97) in a Keyport silt loam (Accession No.
44
-------
00155104). The Freundlich desorption coefficient for
terbacil were 0.67 ml/g (Kx=6l ml/g; l/n=0.45) in
Woodstown sandy loam, 1.5 ml/g (Koc=71 ml/g;
l/n=0.35) in Cecil sandy loam; 2.6 ml/g (K^.^104 ml/g;
l/n=0.26), and 2.5 ml/g ^=92 ml/g; l/n=0.26) in a
Keyport silt loam. Radiolabeled terbacil had Freundlich
adsorption coefficient of 2.46 ml/g (Koc=63.6 ml/g) in a
Webster silty clay loam,, 0.38 ml/g 1^=42.2 ml/g) in a
Cecil sandy loam, 0.38 ml/g (K^.-76 ml/g) in a Glendale
sandy clay loam, and 0.12 ml/g (8^=21.4) in Eustis fine
sand (05014424, Davidison etal., 1978;05008371, Rao and
Davidison, 1979). Radiolabeled terbacil, at 1 /eg/ml, had
Freundlich adsorption coefficients ranging from 0.72 ml/g
0^=57.6 ml/g; l/n=0.73) to 1.65 ml/g (1^=84.6 ml/g;
l/n=0.97) for twelve mineral soils (05014175, Liu et al.,
1971). Terbacil had a soil TLC Rf of 0.54 for a
Woodstown sandy loam, 0.36 for a Cecil sandy loam, 0.28
for a Flanagan silt loam, and 0.27 for Keyport silt loam.
Terbacil and its minor transformation products' were
leached through 30 cm columns of Flanagan silt loam and
Sassafras sandy loam soil when eluted with 20 inches of
0.01 M CaClj (MRID 42335401). Terbacil was
predominately detected in leachate samples. Minor
transformation products (9 to 11% of applied terbacil) in the
leachate samples were t-butylurea, and 3-t-butyl-6-
methyluracil and 6-chloro-2,3-dihydro-7 (hydroxymethyl)-
3,3-dimethyl-5H-oxazolo(3,2-a)pyrimidin-5-one. In an
ancillary study, Radiolabeled terbacil, at 2 Ibs/A, was
leached (4 to 64% of applied radioactivity) through 18 inch
packed soil columns of Fallsington sandy loam and Flanagan
silt loam when eluted with 20 inches of water (Rhodes,
1981). Also, "unidentified" terbacil residues were leached
(4 to 52% of applied radioactivity) through packed soil
columns of Fallsington sandy loam and Flanagan silt loam.
Radiolabeled terbacil (73, to 90% of applied radioactivity)
was leached through 30 cm columns of surface and
subsurface Wabasso fine sand when eluted with 15.5-to-20
inches of 0.01 M CaSO4. Based on plant bioassays,
phytotoxic terbacil residues were eluted with 10 to 20 cm of
water to a depth of 27.5 to 30 cm in packed 30 cm soil
columns of Fox sandy orchard soil (05013202, Marriage et
al. 1977).
45
-------
The Batch Equilibrium/Soil Column Leaching (163-
1) data requirement is fulfilled. No additional mobility data
are needed at this time.
(b) Laboratory Volatility
The Laboratory Volatility (163-2) data requirement
is waived because terbacil has a low vapor pressure (4.7 x
10"7 mm Hg at 29.5°C) and low Henry's Constant (1.9 X
10-9 atm m3/mol).
(3) Accumulation
(a) Fish
Radiolabeled terbacil, at 0.01 and 1.00 fig/ml, was
accumulated, respectively, at concentrations of 0.11 and 7.9
in viscera, 0.02 and 1.8 /tg/g in head, 0.07 and 4.4
in the livers, and 0.02 and 1.7 /tg/g in edible tissues of
bluegill sunfish over 4 week exposure period (Accession
No. 00011947). Terbacil residues in all fish tissues
declined below the detection limit (<0.01 /ng/g) during a 3
day depuration period. Terbacil was the only radioactive
residue identified in fish tissues. The Bioaccumulation in
Fish (165-4) data requirement is fulfilled. No additional
data are needed at this time.
(4) Field Dissipation
Terbacil (Sinbar 80% wettable powder), spray or broadcast
applied at 5 Ibs a.i./A, had a first order half-life of 212 days on silt
loam soil in Delaware, 204 days on a silty clay soil in Illinois, and
252 days on a sandy loam soil in California (MRID 43585500).
Terbacil "residues" were detected (< 0.09 jtg/g) at a maximum soil
depth of 45 to 50 cm. In California and Delaware field studies, the
terbacil transformation product, 3-t-butyl-5-chloro-6-
hydroxymethyluracil, had a maximum concentration of 0.14 /*g/g
at 15 days and then declined to < 0.8 /tg/g at 60 days
posttreatment. The transformation product, 6-chloro-2,3-dihydro-
7-(hydroxymethyl)-3,3-dimethyl-5H-oxazolo[3,2-a]pyrimidin-5-
one, had a maximum concentration of 0.07 jtg/g at 60 days
posttreatment in the California study;
46
-------
In a supplemental microplot field dissipation study,
radiolabeled terbacil at 2 Ibs a.i./A had a half-life of 1 to 2 months
when incubated in the field for 4 months with a cumulative rainfall
of 18.33 inches (Rhodes, 1981). Terbacil .was detected in the 12 to
15 inch soil segment. In an unacceptable long-term field dissipation
study, terbacil (Sinbar 80% wettable powder), applied at 1.0, 2.0,
and 4.0 Ibs/A/year for 16 consecutive years, did not appear to
accumulate on a study site in Delaware. Terbacil was detected (<
l>g/g) in the surface 12 inches of soil in the 2,0 and 4.0 Ibs a.i./A
treatments. The transformation product, [6-Clair-2,3-dihydro-3,3-
dime%l-7-hydroxymelyl-5H-oxazolo(3,2-)pyrimidine-5-one], was
detected at maximum concentration of 0.06 ^g/g. Radiolabeled
terbacil, at 4 Ibs a.i./A, had an estimated first-order half-life of 131
days when incubated for 52 weeks in microplot field studies (4 inch
diameter x 12 inch depth in situ lysimeter) in a Butlertown silt loam
(Gardiner, et al. 1969) Radiolabeled residues were detected
throughout the lysimeter at 5 weeks posttreatment. The study Site
location and climatic conditions were not reported.
Several field dissipation studies for terbacil have been
reported using chemical non-specific bioassay techniques for
detection of "terbacil residues". Although chemical non-specific
bioassays are not accepted as a reliable analytical technique, the
Agency believes that field dissipation studies using chemical non-
specific bioassays provide ancillary qualitative data on the
dissipation of "terbacil residues". Such data, however, cannot be
used to fulfill the terrestrial field dissipation (164-1) data
requirement.
'. • . " " . v
Terbacil applied at 1.6 Ibs a.i./A in a Washington orchard
soil was detected 1 year posttreatment using oats, beans, and
cucumbers as phytotoxicity indicators (05020698; Benson, 1973).
Phytotoxic terbacil residues were detected at a maximum depth of
18 to 24 inches. No rainfall data were reported. Terbacil, 2.24
kg/ha/year for 4 consecutive years, caused phytotoxic effects on
oats and beans at two years posttreatment on an acidic Camas clay
loam soil (05013351; Doughty, 1978). In contrast, phytotoxic
terbacil residues (< 0.03>g/g) were not detected on a high organic
matter, acidic, Mossy Rock silt loam amended with terbacil at 4.48
kg/ha for 4 consecutive years. Phytotoxic residues from terbacil
(unspecified source), at 2 to 16 Ibs/A, were detected 13 months
posttreatment in surface soil of Mabi clay soil planted with sugar
cane in Puerto Rico (00017711; Liu, L.C. et al. 1977). Phytotoxic
residues from terbacil (unspecified source), as a banded application
47
-------
c.
at 1.2 and 2.4 lbs/A, were detected at 7 months posttreatment on
clay loam soil in California (00028135, Isom, et al., 1969;
05019594, Isom, et al., 1970). Terbacil (unspecified formulation),
applied on the soil surface or incorporated at rates 2.24 and 4.48
kg/ha for three consecutive years, degraded with an estimated half-
life of 157 days on peach orchard sandy soil (sites unspecified)
(05013212, Skroch et al., 1971). Terbacil was detected (< 0.07
Atg/g) at a maximum soil depth of 15 to 30 cm soil following the
second and third year applications.
Terbacil applied at 4.5 kg/ha/year over three applications
was detected (< 100 /tg/L; 0.5 to 1.8% of terbacil) in subsurface
waters at 107 cm in "lysimeters" on a field plot with a Oldsmar
sand in Florida citrus orchard (05017062, Mansell et al., 1979;
05014421, Mansell et al., 1977)
The Terrestrial Field Dissipation (164-1) data requirement
is fulfilled. No additional data are needed at this time.
(5) Spray Drift
No terbacil spray drift-specific studies were reviewed.
Droplet size spectrum (201-i) and drift field evaluation (202-1)
studies were required since the different products may be applied by
aircraft and orchard airblast and due to the concern for potential
risk to flontarget aquatic organisms. However, to satisfy these
requirements the registrant in conjunction with other registrants of
other pesticide active ingredients formed the Spray Drift Task
Force. (SDTF). The SDTF has completed and submitted to the
Agency its series of studies which are intended to characterize spray
droplet drift potential due to various factors* including application
methods, application equipment, meteorological conditions, crop
geometry, and droplet characteristics. Until these data are
evaluated, the Agency is relying on previously submitted spray drift
data and the open literature for off-target, drift rates. The rates are
1% of the applied spray volume from ground applications and 5%
from aerial and orchard airblast applications at 100 feet downwind.
After its review of the new studies the Agency will determine
whether a reassessment is warranted of the potential risks from the
application of terbacil to nontarget organisms.
Water Resources
Terbacil is currently regulated under the Safe Drinking Water Act
(SDWA). EPA's Office of Water has not established a Maximum
48
-------
Contaminant Level (MCL) however it has set Health Advisories (HA's) for
terbacil residues in drinking water. The reference dose (RfD) for a 70-kg
adult was established at 0.013 mg/kg/day. The one day, ten day and
"longer-term" HA for a 10-kg child is 300 jtg/1. The "longer-term" HA
for a 70-kg adult is 900 jig/1, and the Lifetime HA has been set at 90 us/1
(US EPA, 1996).
(1) Ground Water
Terbacil has the characteristics of compounds known to
leach to ground water. (See Environmental Fate Assessment.)
Based on the environmental fate data, terbacil exceeds the mobility
and persistence triggers for the .proposed Restricted Use
Classification for ground water concerns. Currently, there are an
insufficient number of terbacil detections in ground water to
warrant a Restricted Use classification. However, future expansion
of the terbacil use areas is expected to increase the potential for
terbacil to move into ground water.
(a) Leaching Potential
There are no ground-water monitoring studies which
allow an evaluation of the leaching potential of terbacil into
ground water. The environmental fate data indicate that
terbacil may leach -into ground water because of terbacil's
persistence and potential mobility. Barrett (1995) concluded
from a generic screen of leaching potential that terbacil has
a greater leaching potential than other herbicides commonly
detected in ground water at numerous locations.
Table 14: Leaching potential of terbacil compared with some maior use herbicides
Compound
terbacil
GUS Scores
6.38 , .
Major uses
mint, apples, alfalfa
GW Concerns
Compound
terbacil
GUS Scores
6.38
GUS Scores
6.38
Maior uses
mint, apples,
GW Concerns
Compound
terbacil
GUS Scores
6.38
Major uses
mint, apples,
Major uses
mint, apples, alfalfa
GW Concerns
Compound
terbacil
GUS Scores
6.38
Major uses
mint, apples, alfalfa
GW Concerns
Compound
GW Concerns
Compound
terbacil ,
GUS Scores
6.38
Maior uses
mint, apples,
GW Concerns
Compound
terbacil
GUS Scores
49
-------
A Groundwater Ubiquity Score (GUS) score above
2.8 indicates relatively high leaching potential; a score
above 1.8 indicates moderate leaching potential. Median or
typical Koc and half-lives were selected to calculate GUS
scores. Herbicides in the upper half of this list have been
detected in numerous ground-water samples with the
exception of newer, ultra-low rate compounds for which
little monitoring of any kind has been completed to date.
"Yes" indicates a ground-water study has been required to
support registration, environmental fate and field studies
have shown high leaching potential, or there is evidence of
relatively widespread contamination of ground water from
past use; "marginal" indicates that some concerns for
leaching to ground water have been raised in registration or
reregistration but no study to support registration has been
conducted; "no" indicates that concerns for leaching to
ground water have not been identified.
Table 15; Leaching potential of terbacU compared with herbicides with similar use patterns
.Compound
terbacil
terbacil (best case)
hexazinone
metribuzin
simazine
ametiyn
asulam
diuron
2,4-D
pendimethalin
bromoxynil
trifluralin
GUS Scores
6.38
5.32
5.29
4.48
3.77
3.41
2.84
2.73
2.70
0.66
0.25
0.19
"Uses ' - ,
alfalfa, apples, mint, sugarcane
alfalfa, apples, mint, sugarcane
alfalfa, sugarcane
alfalfa, sugarcane
alfalfa, apples
sugarcane
sugarcane
alfalfa, sugarcane, apples
alfalfa, apples, sugarcane
mint, sugarcane
alfalfa, mint
alfalfa, mint, sugarcane
(b) Ground Water Monitoring Data
Based on information from the "Pesticides in Ground
Water Database", terbacil has not been detected frequently
in ground water (Hoheisel et al., 1992). The monitoring
data indicate that terbacil was detected in six wells from a
total 288 wells across six states. Terbacil was detected in a
well in Oregon at a concentration of 8.9 jtg/L and five wells
in West Virginia at a concentration range of 0.3 to 1.2
lig/L.
50
-------
The lack of detections of terbacil in ground water
may be associated with the limited geographical extent of
the terbacil use area as well as the relatively low total
environmental loading compared to other herbicides.
Additionally, ground water monitoring data has been
reported for areas with no terbacil use. For example, the
single largest groundwater monitoring program, as reported
in the "Pesticides in Ground Water Database", was
conducted in Mississippi. Forty-one percent of the
monitoring data , were taken from wells in Mississippi,
However, terbacil usage data indicate that terbacil is not
used in Mississippi (DuPont and Resources for the Future)
data. Also, the estimated annual use of terbacil, in terms of
pounds of active Ingredient, is one tenth to one hundredth
of the annual use of herbicides commonly detected in
ground water such as atrazine, alachlor, metolachlor,
cyanazine, dicamba, metribuzin, and simazine. Another
possible reason for the low frequency of detections of
terbacil in some ground-water monitoring surveys are high
limits of detection for terbacil. In most of the state surveys,
the limits of detection for terbacil has been 5 to 100 times
higher (i.e., less sensitive) than the limits of detection for
widely used herbicides. Barrett (1995) reported that limits
of detection for terbacil from the Mississippi and
Washington monitoring programs ranged from 3.5 to 4 6
(c) Comparative Leaching Assessment
The PATRIOT model was used to perform a
comparative leaching assessment of terbacil relative to a
conservative tracer, and other common herbicides.
PATRIOT is a program to run Pesticide Root Zone Model
- 2 (PRZM). PRZM is a one-dimensional, dynamic,
compartmental model that can be used to simulate pesticide
movement in unsaturated soil systems within and
immediately below the plant root zone. '
PATRIOT modeling for terbacil was conducted on
representative soils for apple production in New York and
Oregon, peaches in Georgia and sugarcane in Louisiana.
The leaching of terbacil was then compared to the potential
leaching of atrazine and bromide. Atrazine was selected
because it is a well characterized corn herbicide and is
51
-------
known to leach to ground water. Bromide was selected
because it is an anibn in aqueous environments, resists
binding, will move with the water front and is often used as
a tracer for ground water research and studies. Additional
assumptions and input from the PATRIOT modeling are
appended to the end of this document.
Hydrologic Group C soils were used for modeling of
apple production hi New York and Oregon. These soils are
less prone to leaching and have a much higher potential for
surface water runoff. PATRIOT modeling predicted that
approximately 40% of the terbacil mass applied could leach
to shallow ground water (4.5 feet) on the apple use sites.
Comparative modeling on the same soils predicted that
< 1% of atrazine could leach, while 70-87% of bromide
could leach.
Georgia peach production areas were modeled using
Hydrologic Group D soils which have the least potential for
leaching. PATRIOT modeling predicted that approximately
51% of the applied terbacil could leach to shallow ground
water. In comparison, 18% of atrazine could leach, and
59% of bromide could leach.
Ten Louisiana sugarcane soils were selected for
modeling with PATRIOT. The PATRIOT database
indicates that the Commerce (Aerie Fluvaquent) and
Patoutville (Aerie Orchraqualf) soils account the largest
acreage of sugarcane in Louisiana. These soils are
classified as Hydrologic Group C and were predicted to
have a moderate potential to leach. PATRIOT predicted
that 47-51% of the applied terbacil would leach to shallow
ground water. Several of the lower acreage Group D soils
had the highest leaching potential with 64-75% of the
terbacil mass predicted to leach. These soils only represent
a small portion of the Louisiana sugarcane production area.
Not unexpectedly, leaching is related to the amount
of precipitation received. Thus the estimates of the annual
leaching of terbacil on Group B, C, and D soils is strongly
Controlled by the rainfall, which can be highly variable.
Calculations are presented as ten year mean values to
account for variability in precipitation. Since terbacil is
persistent in soil, terbacil will probably accumulate in the
52
-------
soil and thus the total mass reaching ground water in a
particular year may exceed the total mass applied in a given
year. The mass of terbacil estimated to leach to ground
water for each year ranged from approximately 0 to 125%
of the annual application.
PATRIOT modeling was not conducted on Group A
soils because Group A soils do not appear to be
representative of the terbacil use areas. In addition, no
modeling was conducted for mint or alfalfa production
because of incomplete usage and soils data.
Figure 1 - Predicted Leaching Using PATRIOT Model (Sugarcane)
Terbacil Use on Sugarcane
Predicted Leaching using PATRIOT model
100
T3
CD
-§ 80
(0
"O
J2 60
Q.
O.
o 40
CD '
2
-------
Figure 2 - Predicted Leaching Using PATRIOT Model (Apples and Peaches)
Terbacil
Predicted Leaching using PATRIOT model
liioo
New York Aooles
Hydrologic Group C Soils
Terbacil
Atrazine
Bromide
2 80
TD
-------
water concentrations from ground water monitoring studies,
environmental fate properties (aerobic soil half-lives and
organic carbon partitioning coefficients-Kocs) and
application rates.
Results from the SCI-GRO screening model show
that the maximum chronic concentration of terbacil in
shallow groundwater is not expected to exceed 125 /tg/L for
me majority of the use sites. Uncertainties in,the SCI-GRO
are: 1) The screening model does not consider site specific
factors regarding hydrology, soil properties, climatic
conditions, and agronomic practices; 2) The screening
model does not account for volatilization; and 3) Predicted
ground water concentrations are linearly extrapolated from
.- the application rates. Drinking water standards for human
health are 1.) the childrens HA is 300 /tg/1 (ppb), 2.)the
adult "longer term" HA is 900 ppb, and 3.) the adult
lifetime HA is 90 ppb.
Although groundwater screening models indicate
terbacil could potentially contaminate shallow ground water
near specific use sites, there is a small chance terbacil
concentrations in groundwater would exceed EPA's
drinking water standards from the current terbacil use
patterns. This assessment is based on the fact that terbacil
is used in limited use areas on minor crops coupled with
relatively low environmental loading. Expanded use of
terbacil, especially on major crops, may trigger the need for
a small-scale prospective ground water study and surface
water monitoring.
(2) Surface Water
Since terbacil is applied as an aerial and ground spray, there
is potential for direct spray drift deposition into surface waters
adjoining target use sites. The drift potential for aerial and ground
spray is assumed to be equivalent to 5% of applied and 1% of
applied, respectively. Terbacil is very persistent (t1/2 = 653 days)
and potentially mobile (K^ = 54 ml/g) in terrestrial environments.
The major routes of terbacil dissipation appear to be dependent on
microbial-mediated degradation and movement into ground and
surface waters. Volatilization is not expected to be a major route
of dissipation for terbacil because it has a low vapor pressure (4.80
x 10-7 Torr) and low Henry's Constant (1.90 X 10'10 atm*m3/mole)
for terbacil. The reported environmental fate data suggest terbacil
can be dissolved in runoff waters.
55
-------
Once in surface water, the dissipation of dissolved terbacil
appears to be dependent on photodegradation. The
photodegradation half-life for terbacil is 29 days.
Photodegradation of terbacil is enhanced in the presence of some
photosensitzers. Photodegradation is expected to be a predominant
dissipation pathway in clear, shallow waters with long hydrologic
residence times. Terbacil is not expected to be found in bottom
sediments because it exhibits low soil/sediment sorption affinity
(average. K,,,. = 54 ml/g). No data are available to assess the
persistence of terbacil in aquatic environments.
The following data (Table 15) were used for input into the
GENEEC and PRZM-EXAMS modeling for terbacil:
Table 15: Data Used for GENEEC and PRZM- EXAMS Modeling
Parameter
soilK^
Aerobic soil half-life
Aerobic aquatic half-life
Photolysis Half-life (pH 7)
Hydrolysis (pH 7)
Water Solubility
Value
54ml/gl
653 days2
Source
00155104
42369901
No available data
29 *»»
Stable
710mg/l
Rhodes, 1975
0001946
EFGWB One-Liner
'MeanKoc
^trapolated half-life
3Photodegradation half-life does not reflect enhanced degradation from photosensitzers.
Table 16: Estimated Environmental Concentrations (EECs) For Aquatic Exposure
Site
Application
Method
Application
Rate
ObsaJL/A}
Initial
(PEAK)
EEC(ppb)
aaUcfay
average
EEC (ppfe)
56-day
average
EEC
-------
Tier 1 GENEEC modeling indicates that terbacil' may reach
surface waters at concentrations ranging from 19 to 154 ptg/L
(Table 19). The higher EEC's for terbacil correspond with ground
application of terbacil at rates of 3.2 Ibs a.i./A/season on
sugarcane, apples, peaches, blueberry, and poplar-Kentucky. A
more refined Tier H PRZM-EXAMS modeling for sugarcane,
peaches, and apples was used for the dietary risk assessment. More
refined modeling was not conducted for blueberries and hybrid
poplar because they have a limited production area. Tier n surface
water modeling was conducted using the following scenarios:
Table 17: Tier H PRZM-EXAMS Modeling Input Parameters
Crop
Peaches
Sugarcane
Apples
Location
Peach Co., GA
Jackson Co., LA
Washington Co., OR
Columbia Co., NY
Weather (MLKA)
P133A
O-134
A2
144B
Soil
Boswell sandy loam (D)
Commerce silt loam ®
Cornelius silt loani ®
Sharkey clay loam (D)
Soil Taxonomy
Vertic Paleudalf
Aerie Huvaquvent
Mollic Fragixeralf
Vertic Haplaquept
(. ^-Indicates Hydrologic Soil Grouping
The runoff scenarios were conducted using the standard 1:10
ratio farm pond watershed. Conservative runoff simulations were
conducted from 1948 to 1983. Actual weather data were used for
the 36 year simulation (Burns, et al. 1992); Average annual EECs
in the water column were calculated for the peak EEC (immediately
after loading), 96 hour EEC, 21 day EEC, 60 day EEC, and 90 day
,EEC. The runoff simulations were conducted for Hydrologic
Group C and D soils. Group C and D soils are considered to be
more suspectable to runoff because of lower saturated hydraulic
conductivities (K^ < 1.417 inches/hr) and/or high water tables
(SCS, 1993). The soil classification for Commerce and Sharkey
soils (e.g., aquic moisture regime) indicates the presence of
seasonally high water tables. The Environmental Fate Division
notes the Sharkey soil. classification for the New York apple
scenario was derived from an outdated soil survey manual. More
recent soil classification indicates the Sharkey soil is found in
Mississippi and Louisiana. The soil classification of the Sharkey
and Boswell soils (e.g., Vertic subgroup) contain expansive clays
(e.g., montorillonite). These soils may have extensive cracks
which serve as macropores for by-pass flow conditions. In
contrast, soil classification of the Cornelius soil indicates the
presence of a fragipan. A fragipan is expected to limit water flow
through the soil profile. These specific soil hydrological conditions
were not considered in the environmental fate modeling.
57
-------
PRZM-EXAMS EECs suggest terbacil may accumulate in
static surface waters from long-term use. (See below Figure.)
Exceedance EECs for terbacil were not calculated because there
was residue accumulation in the surface water body with successive
annual applications. Instead, the 36 year cumulative peak EECs are
reported as the representative upper bound Tier n EECs (Table 2).
The PRZM-EXAMS cumulative peak EECs were 63 jig/L (70% of
est. HA) for peaches, 1470 ^g/L (1500 % of est HA) for
sugarcane, 28 /tg/L (31% of est. HA) for western apples, and 178
fig/L (198% of est. HA) for eastern apples. Further analysis of the
Tier II peak EECs indicate the first year EEC and annual
incremental concentration (slope) were 105 and 36 jtg/L for LA
sugarcane, 24 and 4.3 /tg/L for NY apples, 34 and 0.81 ^g/L for
GA peaches; and 5.2 and 0.52 /tg/L for WA apples. The annual
incremental concentration was derived from the slope of a linear
regression models fit to Tier n peak EECs accumulation over a 36
year computer simulation period. There is uncertainty in the slope
estimates for GA peaches and WA apples because of a poor fit of
the linear regression models. Results of the simulation suggest
that surface water runoff may be an important route of dissipation
for terbacil. The model predicted accumulation of terbacil in
surface waters may be an artifact of the computer simulation for
several reasons: 1.) surface water hydrology of the pond does not
account for outflow and/or dilution processes; and 2.) aerobic
aquatic metabolism for terbacil was not considered as a route of
dissipation.
Table 18: Tier n Maximum PRZM-EXAMS Aquatic Estimated Environmental
Concentrations for Terbacil
Crop
Peaches
Sugarcane
Apples
Location
GA
LA
OR
NY
Rate
kg a.i./faa
2.554
3.400"
2.980
3.400
jPeakEEC
tepfc)
63
1470
28
178
Day 4 EEC
(PI*>
63
1460
28
177
Day 21 EEC
-------
parishes: Cameron, Point Coupee, Madison, West Feliciana,
Rapides, and Richland. The 1992 Census of Agriculture indicates
that sugarcane production in Louisiana can be found only in Point
Coupee Parish (12,583 acres or 4% of production area) and Rapides
Parish (2,336 or 0.65% of the production area). GIS analysis of
the terbacil use area in Louisiana indicates that Point Coupee is the
only parish to overlap the terbacil use area (See attached Figures).
The integration of the sugarcane production area and monitoring
data suggests STORET monitoring data for terbacil may not be
representative of the sugarcane production area. Surface water
drinking water facilities on major rivers and bayous are present in
the sugarcane production area and serve a total population of
148,200 people (ReachScan, 1991). Activated charcoal filtration
is not expected to remove terbacil from surface water because
terbacil sorption affinity (expressed as a Kj) does not appear to be
dependent on the organic carbon content of soils.
Figure 3 - PRZM-EXAMS TERBACIL (Surface Water Concentrations)
1400 -
1200 •
1000-
t 800 •
.3
^ 600 -
1
o 400 -
»
* 200 -
PRZM-EXAMS TERBACIL
Surface Water Concentrations
••
> ' *
•/~~
0 •*=
194,
-s£L
—p.
™X!~
ir*
— :
.*^^t
J/^ .
: .j
'?*"
*esHL
B 1953 1958 1963
Yeats of Application
"
^ —
1968 19:
-gn^^
73
•MEEuunw
••— -a^i
--^«
x*"1-
^^-
1978 1983
— LA Cane — -WA Apples NY Apples - — - GA Peaches
3. Exposure and Risk Characterization
A means of integrating the results of exposure and ecotoxicity data is
called the quotient method. Fortiiis method, risk quotients (RQs) are calculated
by dividing exposure estimates by ecotoxicity values, both acute and chronic.
59
-------
RQ = EXPOSURE/TOXICITY
RQS are then compared to OPP's levels of concern (LOCs). These LOCs
are criteria used by OPP to indicate potential risk to nontarget organisms and the
need to consider regulatory action. The criteria indicate that a pesticide used as
directed has the potential to cause adverse effects on nontarget organisms. LOCs
currently address the following risk presumption categories: (1) acute high -
potential for acute risk is high, regulatory action may be warranted in addition to
restricted use classification (?) acute restricted use - the potential for acute risk
is high, but this may be mitigated through restricted use classification (3) acute
endangered species - the potential for acute risk to endangered species is high,
regulatory action may be warranted, and (4) chronic risk - the potential for
chronic risk is high, regulatory action may be warranted. Currently, the Agency
does not perform assessments for chronic risk to plants, acute or chronic risks to
nontarget insects, or chronic risk from granular/bait formulations to mammalian
or avian species.
The ecotoxicity test values (i.e., measurement endpoints) used in the acute
and chronic risk quotients are derived from the results of required studies.
Examples of ecotoxicity values derived from the results of short-term laboratory
studies that assess acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and
mammals (3) EC50 (aquatic plants and aquatic invertebrates) and (4) EC25
(terrestrial plants). Examples of toxicity test effect levels derived from the results
of long-term laboratory studies that assess chronic effects are: (1) LOEC (birds,
fish, and aquatic invertebrates) (2) NOEC (birds, fish and aquatic invertebrates)
and (3) MATC (fish and aquatic invertebrates). For birds and mammals, the
NOEC value is used as the ecotoxicity test value in assessing chronic effects.
Other values may be used when justified. Generally, the MATC (defined as the
geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in
assessing chronic effects to fish and aquatic invertebrates. However, the NOEC
is used if the measurement end point is production of offspring or survival.
Risk presumptions, along with the corresponding RQS and LOCs are
tabulated in Table 19 below.
60
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Table 19: Risk Presumptions for Terrestrial Animals
Bisk Presumption
RQ
' -' - \ Blras '
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EECVLC50 or LD50/sqft or LDso/day3
EEC/LCSO or LDso/sqft or LDso/day (or LD50 < 50 mg/kg)
EEC/LCSO or LD50/sqft or LDso/day
EEC/NOEC
- " - ' Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC50 or LD50/sqft or LDso/day
EEC/LCSO or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LCSO or LD50/sqft or LD50/day
EEC/NOEC
LOC
'
0.5
0.2
0.1
1
0.5
0.2
0.1
1
me/ft2 3 mg of toxicant consumed/day
LD50 * wt. of bird
LD50 * wt. of bird
Table 20; Risk Presumptions for Aquatic Animals
Risk Presumption _
Acute High Risk
Acute Restricted Use
Acute Endangered Species,
Chronic Risk
, ^ RQ ^»
EECVLCsoorECso
EEC/LC50orEC50
EEC/LCsoorECso
EEC/MATCorNOEC
'EEC = (ppm or ppb) in water '
HfcOC
0.5
0.1
0.05
1
,v Risk Presumption
^ "" %
T«rres6rlal Plants
Acute High Risk
Endangered Species
EECVEC25
EEC/EC05orNOEC
, Aqtta1»iJ?|ant$
Acute High Risk
Endangered Species
EEC2/EC50
EEC/EC05 or NOEC
!EEC = Ibs a.i./A , . ~ — '
\ i,d'ev'
-
i
i
i
i
2EEC = (ppb/ppm) in water
a.
Ecological Exposure and Risk Characterization
(1) Exposure and Risk to Nontarget Terrestrial Animals
*
For pesticides applied as a nongranular product (e.g., liquid,
dust), the estimated environmental concentrations (EECs) on food
61
-------
items following product application are compared to LCSO values to
assess risk. The predicted 0-day maximum and mean residues of a
pesticide that may be expected to occur on selected avian or
mammalian food items immediately following a direct single
application at 1 Ib a.i./A are tabulated in Table 22 below.
Table 22: Estimated Environmental Concentrations on Avian and Mammalian Food Items
;Foo5 Items
Short grass
Tall grass
Broadleaf/forage plants, and small insects
Fruits, pods, seeds, and large insects
EEC j*m)
768
352
432
48
fcC^iMn)
21141
21141
21141
21141
! Acute RQ
(jEEC/LCa,)
- 0.04
0.02
0.02
0.00
'The LCjo for pheasant was used as a toxicity endpoint for birds because pheasant was the only agency approved species
with a measurable LC^,. All other approved species have greater LC50's when compared to pheasants.
2Since the highest rate of application did not exceed any LOG for the level of acute risk, RQ's for lower application
rates were not calculated.
There is no acute risk to birds at the highest
application rate (3.2 Ibs a.i./acre) for terbacil. A chronic
risk assessment for birds can not be made because of lack
of reproduction data.
(b) Mammals
Estimating the potential for adverse effects to wild
mammals is based upon the Environmental Fate's draft 1995
SOP of mammalian risk assessments and methods used by
62
-------
Hoerger and Kenaga (1972) as modified by Fletcher et al.
(1994). The concentration of Terbacil in the diet that is
expected to be acutely lethal to 50% of the test population
(LCjo) is determined by dividing the LDSO value (usuaUy rat
LDso) by the % (decimal of) body weight consumed. A risk
quotient is then determined by dividing the EEC by the
derived LC5o value. Risk quotients are calculated for three
separate weight classes of mammals (15, 35, and 1000 g),
each presumed to consume four different kinds of food
(grass, forage, insects, and seeds). The acute risk quotients
for 3.2 Ib a.i./A broadcast application of terbacil are
tabulated in Table 24 below.
Table 24: Mammalian (Berbivore/Insectivore) Acute Risk Quotients for Single Application
of Nongranular Products (Broadcast) of Terbacil2
Application
Kate
m Ibs a.L/^'
3.2*
3.2
3.2
Bo%
Weight
®
15
35
1000
•>f I T\ >
% Body '
Wefeiit
Consumed
95
66
15
Rat
£»*
(«£/&$
5000
5000
5000
EEC
Forage & '
Small Jnsecfc
432
432
432
EEC
-------
Table 25: Mammalian Chronic Risk Quotients for Terbacil Based on a Rat NOEL >250
ppm in a 3-generation rat study
; ^ '', %£/ '' ''I '
SIte/AjJplieatioB M«tfioa
v. v Tf ,SV "">*, < , , - ' •
Sugarcane, peach, apple,
blueberry.
Popular - Kentucky.
(ground application)
Asparagus
(ground application)
Sugarcane
(aerial application)
Alfalfa - north eastern states
(ground application)
Mint, Caneberries, Poplar -
Washington and Oregon
(aerial and ground
application)
Alfalfa
(aerial and ground
application)
Strawberry, Grass Seed -
Oregon (ground application)
'^ji^^Mi'" *
-B^-ia^a^l'':
3.2
2.4
2.0
1.8
1.6
1.2
1.0
Fwdltssas ,''"', -I
' f f f ,, :
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
jMaxiaSuKt-
m
-------
used for assessing acute and chronic risks to aquatic organisms.
Acute risk assessments are performed using peak EEC values for
single and multiple applications. Chronic risk assessments are
performed using the 21-day average EECs for invertebrates and 56:
day EECs for fish.
(a) Freshwater Fish
i
For a possible "worst case" scenario for acute risk,
a direct application of terbacil to 6 inches of water should
result in the highest possible exposure to aquatic organisms
from the labeled use of terbacil. The only scenario for
direct exposure to water would be from aerial application to
alfalfa, mint and sugarcane. A simple dilution of the
maximum rate of application for terbacil (3.2 Ib a.i./A) to
a surface acre of water at 6 inches deep is expected to yield
a maximum concentration of 2,316 ppb . Since aerial
application is assumed to have a 60% application efficiency,
aquatic organisms will be exposed to 1380 ppb. The lowest
LC5o for fish is 46.2 ppm for rainbow trout. The risk
quotient (RQ) is derived by dividing the exposure (1.4 ppm)
by the toxicity value (46^2 ppm). The RQ for freshwater
fish is 0.03 which is below the level of concern (LOG) for
fish. A chronic risk assessment cannot be completed
because of insufficient toxicity data.
(b) Freshwater Invertebrates
For a possible "worst case" scenario for acute risk,
a direct application of terbacil to 6 inches of water should
result in the highest possible exposure to aquatic organisms
from the labeled use of terbacil. The only scenario for
direct exposure to water would be from aerial application to
alfalfa, mint and sugarcane. A simple dilution of the
maximum rate of application for terbacil (3.2 Ib a.i./A) to
a surface acre of water at 6 inches deep is expected to yield
a maximum concentration of 2,316 ppb. Since aerial
application is assumed to have a 60% application efficiency,
aquatic organisms will be exposed to 1,380 ppb. The lowest
LC50 for aquatic invertebrates is 65 ppm for Daphnia
magna. The risk quotient (RQ) is derived by dividing the
exposure (1.4 ppm) by the toxicity value (65 ppm). The
calculated RQ for freshwater fish is 0.02 which is below
the levels of concern (LOG) for aquatic invertebrates. A
65
-------
complete chronic risk assessment cannot be completed
because of insufficient toxicity data.
(c) Estuarine and Marine Animals
In order to estimate risk to estuarine and marine
animals, the toxicity values for estuarine/marine animals are
compared to, the toxicity of freshwater aquatic animals.
Estuarine/marine fish is less sensitive to terbacil than the
freshwater fish. The estuarine/marine aquatic invertebrates
have similar toxicity values to the freshwater invertebrates.
Based on the risk quotients for freshwater fish and
invertebrates, it is assumed the LOCs will not be exceeded
for estuarine/marine animals from the labeled use of
terbacil. A chronic risk assessment cannot be completed
because of insufficient toxicity data.
(3) Exposure and Risk to Nontarget Plants
(a) Terrestrial and Semi-aquatic
Terrestrial plants may be exposed to pesticides from
runoff, spray drift or volatilization. Plants in semi-aquatic
areas are those that inhabit low-lying wet areas that may be
dry at certain times of the year. The Environmental Fate
Division's runoff scenario is: (1) based on a pesticide's
water solubility and the amount of pesticide present on the
soil surface and its top one inch (2) characterized as "sheet
runoff' (one treated acre to an adjacent acre) for terrestrial
. plants (3) characterized as "channelized runoff' (10
treatedacres to a distant low-lying acre) for semi-aquatic
plants and (4) based on % runoff values of 0.01, 0.02, and
0.05 for water solubility of < 10 ppm, 10-100 ppm, and
> 100 ppm, respectively. Spray drift exposure from ground
application is assumed to be 1 % of the application rate.
Spray drift from aerial, airblast, forced-air, and chemigation
applications is assumed to be 5% of the, application rate.
EECs are calculated for the following application methods:
(1) unincorporated ground applications, (2) incorporated
ground application, and (3) aerial, airblast, forced-air, and
chemigation applications. Formulae for calculating EECs
for terrestrial plants inhabiting areas adjacent to treatment
sites and EECs for plants in semi-aquatic areas are in an
addendum. Estimated environmental concentrations for
66
-------
terrestrial and semi-aquatic plants are tabulated in table 26
below.
Table 26: Estimated Environ]
Aquatic Plants for a Single A
Sfce/AgpiifcatiOB % ^ ''"' ,
M&h6& £ate t£Jg$f&tit>i%ita.B£*£st£r
rffsff f f
«,,,,,-'
Sugarcane, peach, apple, blueberry
Popular- Kentucky (Unincoiporated Ground)
3.2
Asparagus (Unincorporated Ground) 2.4
Sugarcane (Unincorporated Ground) 2.0
Sugarcane (Aerial) 2.0
Alfalfa- Northeast States (ground) 1.8
Mint, caneberries Poplar- Washington,
Oregon (Unincorp. Ground) 1.6
Mint (aerial) 1.6
Alfalfa (Aerial) 1.2
Alfalfa (Unincorporated Ground) 1.2
Strawberry (Unincorporated Ground). 1.0
Grass Seed- Washington (Ground) 0.6
Strawberry (Ground) 0.4
mental Concentrations (Ibs a.i./A) For Terrestrial and Semi-
pplication
•wBuUBUJlJSt
Snc»Tp<»,
fi^&frt^
0
0
0
0
0
0
0
0
0
0
, o
0
BunoB
'Vkh»
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
' Steeds
XiHWf£r
$bs
a.UA|
0.16
0.12
0.10
0.06
0.09
0.08
0.05
0.04
0.06
0.05
0.03
0.02
CliiutneSze
dSttrwS
^M./A?
1.60
1.20
1.00
0.36
0.90
0.80
0.30
0.24
0.60
0.50
0.30
0.20
ftift
4-J&S
£*-«&
0.03
0.02
0.02
0.10
0.02
0.02
0.08
0.06
0.01
0.01
0.01
0.00
: "TofaiioBiateg'
•to AdgaeeBt:
. A*#.m&$'"
•Ktta^«*Jirtft)
. 0.19
.0.14
0.12
0.16
0.11
0.10
0.13
0.10
0.07
0.06
0.04
X0.02
Total £oafif+
»rfft)
1.63.
1.22
1.02
0.46
0.92
0.82
0.38
0.30
0.61
0.51
0.31
0.20
The ECjs value of the most sensitive species in the
seedling emergence study is compared to runoff plus drift
exposure to determine the risk quotient (EEC/toxicity
value). The EC^ value of the most sensitive species in the
vegetative vigor study is compared to the drift exposure to
determine the acute risk quotient. EECs and acute high risk
quotients for terrestrial and semi-aquatic plants based on a
single application are tabulated in Table 27 below.
67
-------
Table 27: Acute High Risk Quotients from a Single Application
Aquatic Plants Based On a (rape) Seedling Emergence EC25
(cucumber) Vegetative Vigor EC25 of 0.0022 Ib aa./A
for Terrestrial and Semi-
of 0.013 Ib a.i./A and a
'$£&$,"
Htmte
Aqwrfic
Sugarcane, peach, apple,
blueberry (Ground) 3.2
0.013
0.0022
0.03
0.19
1.63
14.62
125.38
13.64
Asparagus (Ground) 2.4
0.013
0.0022
0.02
0.14
1.22
10.77
93.85
9.09
Sugarcane (Ground) 2.0
0.013
0.0022
0.02
0.12
1.02
9.23
78.46
9.09
Sugarcane (Aerial) 2.0
0.013
0.0022
0.10
0.16
0.46
12.31
35.38
45.45
Alfalfa- Northeast
(Ground) 1.8
0.013
0.0022
0.02
0.11
0.92
8.46
70.77
9.09
Mint, canebenies
(Ground) 1.6
0.013
0.0022
0.02
0.10
0.82
7.69
63.08
9.09
Mint (Aerial) 1.6
0.013
0.0022
0.08
0.13
0.38
10.00
29.23
36.36
Alfalfa (Aerial) 1.2
0.013
0.0022
0.06
0.10
0.30
7.69
23.08
27.27
Alfalfa (ground) 1.2
0.013
0.0022
0.01
0.07
0.61
5.38
46.92
4.55
Strawberry (ground) 1.0
0.013
0.0022
0.01
0.06
0.51
4.62
39.23
4.55
Grass Seed- Washington
(Ground) 0.6
0.013
0.0022
0.01
0.04
0.31
3.08
23.85
4.55
Strawberry (Ground) 0.4
0.013
0.0022
0.00
0.02
0.20
1.54
15.38.
0.00
The results indicate that for a single application,
acute risk and endangered species levels of concern are
exceeded for terrestrial and semi-aquatic plants (including
endangered species) for all registered application rates of
terbacil. Currently, the Agency does not perform
assessments for chronic risk to terrestrial and semi-aquatic
plants. The NOEC or EC05 (if NOEC is unavailable) value
of the most sensitive species in the seedling emergence study
is compared to runoff plus drift exposure to determine the
endangered species risk quotient. The NOEC or EC05
value of the most sensitive species in the vegetative vigor
study is compared to the drift exposure to determine the
endangered species risk quotient. Since the LOCs for non-
target plants are exceeded at all rates of application, it is
assumed that the labeled use of terbacil may affect
endangered species of plants.
(b) Aquatic
Exposure to nontarget aquatic plants may occur
through runoff or spray drift from adjacent treated sites or
directly from such uses as aquatic weed or mosquito larvae
control. An aquatic plant risk assessment for acute risk is
68
-------
usually performed for aquatic vascular plants from the
surrogate duckweed Lemna gibba. Non-vascular acute
aquatic plant risk assessments are performed using either
algae or a diatom, whichever is the most sensitive species.
An aquatic plant risk assessment for endangered species is
usually performed for aquatic vascular plants from the
surrogate duckweed Lemna gibba. , To date there are no
known non-vascular plant species on the endangered species
list. Runoff and drift exposure is computed from
GENEEC. The risk quotient is determined by dividing the
pesticide's initial or peak concentration in water by the plant
EC$o value. Acute risk quotients for vascular and non-
vascular plants are tabulated in Table 28 below.
Table 28: Acute Risk Quotients for Aquatic Plants based upon a duckweed (Lemna gibba)
ECso of 0.140 ppm a.i. and a nonvascular plant (Navicula pefficulosa) EC^ of 0.011 ppm a i
For endangered species, the L. gibba NOEC of 0.065 own a.L.
WX&SZrimy&^'Sttfret ' '''
%>lwartl&»4ttjfejiax^ ,- „ ' \i
Sugarcane, peach, apple, blueberry and
Poplar- Kentucky (Ground)
3.2
Asparagus (Ground)
2.4
Sugarcane (Ground)
2.0
Sugarcane (Aerial) ,
2.0 >
Alfalfa- Northeast (Ground)
1.8
Mint, caneberries (Ground)
Poplar- Washington, Oregon
1.6
Mint (aerial)
1.6
Alfalfa (Aerial)
^•2
Alfalfa (Ground)
Strawberry, Grass Seed - Oregon (Ground)
1.0 .
Grass Seed - Washington (Ground)
0.6
Strawberry (Ground)
0.4
:%edffeg- -• , '
duckweed
algae or diatom
duckweed
algae or diatom
duckweed .
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
Igae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
uckweed
ilgae or diatom
"»s¥"
lyu^-
&m
0.140
0.01]
0.14C
0.011
0.14C
0.011
0.14C
0.011
0.140
0.011
0.140
3.011
31140
3.011
).140
).011
).140
).011
).140
):011
).140
).011
1.140
l.Oll
^C
^>
0.065
,
0.065
• — _
0.065
0.065
0.065
0.065
0.065
.
0.065
0.065
0.065
0.065
0.065
Endanger^
Species »q
$BCftiQ8C
2.37
L77
1.48
1.46
-— .
1.32
1.15
1.17
' .....
0.86
_ —
0.88
— _
0.74
0.43
0.29
— _
: $3a-ferg!et
'$te&tM)>
i-CEBCyiSSC^),
1.10
14.00
0.82
10.45
0.69
8.73
0.68
8.64
0.61
7.82
0.54
6.82
0.54
6.91
0.40
5.09
0.41
5.18
0.34
4.36
0.20
2.55
0.14
1.73
69
-------
The LOG for non-target aquatic vascular plants are
exceeded at all application levels. The LOG for algae or
diatoms are not exceeded at any level of rate of application.
The LOG for endangered species of aquatic plants are
exceeded at 1.6 Ib a.i./A application rate or higher. (Non-
vascular endangered species are not known to exist at this
time).
(4) Endangered Species
Endangered species LOCs are exceeded for mammals
(chronic basis) and non-target terrestrial/ aquatic plants. The
Endangered Species Protection Program is expected to become final
in the future. Limitations in the use of terbacil will be required to
protect endangered and threatened species, but these limitations
have not been defined and may be formulation specific. The Agency
anticipates that a consultation with the Fish and Wildlife Service
will be conducted in accordance with the species-based priority
approach described in the Program. After completion of
consultation, registrants will be informed if any required label
modifications are necessary. Such modifications would most likely
consist of the generic label statement referring pesticide users to use
limitations contained in county Bulletins.
b. Water Resources Risk Implication for Human Health
The Agency concludes that terbacil can potentially move into
ground and surface waters. However, the fact that terbacil is used
exclusively on minor crops with very localized site conditions is expect to
limit the potential ecological and human exposure;
(1) Ground Water
In general, the soils in the terbacil use area are classified as
Hydrologic Group B soils. However, terbacil use areas with
potentially vulnerable groundwater are expected to be associated
with mint production in the Pacific Northwest and Midwest (TL and
IN) as well as the sugarcane production in Louisiana and southern
Florida. The sugarcane production area of Louisiana also has a
high concentration of Hydrologic Group C/D soils which are prone
to runoff. Additionally, the sugarcane production areas are
expected to have GW/SW interactions because of the presence of
high water tables.
70
-------
PATRIOT modeling suggest that terbacil could contaminate
very shallow ground water (2.5 to 5 feet) at high concentrations.
The SCI-GRO screening model predicts that the maximum chronic
concentration of terbacil in shallow groundwater (1Q-30 feet) is not
expected to exceed 125 pg/L for the majority of the use sites.
(2) Surface Water
The water resource assessment for terbacil indicates that
terbacil can move into ground and surface waters. The maximum
GENEEC EEC for terbacil was 154 jig/L for sugarcane, apples,
and peaches at application rates of 3.2 Ibs a.i./A.
Tier n surface water assessments were focused on the major
productions areas for sugarcane, peaches, and apples., These
growing areas are located: 1) Pacific Northwest Region (OR and
WA) for apples/peaches ; 2) Mid-Atlantic Region (NY) for apples;
3) southern Piedmont Region (GA) for peaches; and 4) Mississippi
River Delta Region (LA) for sugarcane. Tier II surface water
assessments indicate that terbacil can potentially accumulate in the
"farm pond" runoff scenario. Cumulative 36 year Tier IIPRZM-
EXAMS concentrations ranged from 28 jig/L for' apples in
Washington to 1470 /ig/L for sugarcane in Louisiana. Further
analysis of Tier n EECs indicate the first year EEC and annual
incremental concentration (slope) were 105 and 36 ^g/L for LA
sugarcane; 24 and 4.3 /tg/L for NY apples; 0.00 and 0.81 /ag/L for
GA peaches; and, 5.2 and 0.52 pg/L for WA apples. Predicted
terbacil accumulation in the "farm pond" runoff scenario may be
high because some potential routes of dissipation (e.g.>
metabolism, dilution, etc.) have not been taken into account in the
surface water modeling. Drinking water derived, from surface
waters is expected have concentrations less than the farm-pond
scenario.
4. Environmental Risk Characterization
f • ' ' • .
The risk analysis indicates terbacil is a persistent and potentially mobile
herbicide in terrestrial environments. These environmental fate properties also
suggest that terbacil can potentially move into both ground and surface waters. The
available ground and surface water monitoring data are not representative of the
terbacil use area. Hence, estimated environmental concentrations of terbacil are
based solely on ground and surface water models. .
71
-------
Tier II surface modeling suggest terbacil may potentially accumulate in
surface water at concentrations ranging from 28 to 1470 /tg/L. Further analysis of
Tier II peak EECs indicate the first year EEC and annual incremental
concentration (slope) were 105 and 36 /ag/L for LA sugarcane; 24'and 4.3 jtg/L
for NY apples; 0.0 and 0.81 /ig/L for GA peaches; and 5.2 and 0.52 /ag/L for
WA apples . The annual incremental concentration was derived from the slope of
a linear regression models fit to Tier II peak EECs accumulation over a 36 year
computer simulation period. The peak ground water concentration, based on the
SCI-GRO screening model, is not expected to exceed 125 /*g/L.
Minimal adverse acute effects are expected for avian, mammalian, and
aquatic species from labeled uses of terbacil. Chronic effects for avian and aquatic
species cannot be evaluated at this time because of insufficient data. However,
chronic RQs for mammals indicate that adverse effects are possible from labeled
uses of terbacil. There is some uncertainty • in assessing adverse chronic
mammalian effects because the NOEL is greater than the maximum concentration
tested in rat reproduction study design. Therefore, the highest concentration is a
default toxicity endpoint which is a conservative estimate of risk. Since terbacil
is a persistent and mobile herbicide, non-target terrestrial plants are expected to
be adversely affected from runoff and spray drift. Minimal adverse effects,
however, are expected for non-target aquatic plants. Because terbacil is used
exclusively on minor crops, terbacil exposure is expected to be very localized and
dependent on site specific conditions. The localized nature of terbacil use areas is
expected to limit human and ecological exposure.
Additional data are needed for a complete risk assessment. Chronic toxicity
studies (71-4 Avian Reproduction Study ; 72-4 Fish Early Life Stage and Aquatic
Invertebrate Life Cycle) are needed to assess chronic risk to avian and aquatic
organisms. Wild mammal toxicity study (71-3) is reserved pending a review of
avian reproduction studies. Aerobic aquatic metabolism data (162-4) are needed
to assess the rates and routes of terbacil dissipation in aquatic environments.
5. Integrated Risk Characterization
Analysis of the use characterization information indicate terbacil is used in
localized regions across the United States. These regions have varying potentials
for runoff because of the agronomic/ horticultural practices, climatic conditions,
and site characteristics. Since terbacil is used exclusively on perennial crops
(except sugarcane), a continuous ground cover or minimal soil tillage is expected
which should reduce the potential for runoff. Climatic data indicate the range in
average precipitation can range from 10 to 70 inches in Washington and Oregon
to 45-65 inches hi LA. Additionally, soil data indicate the terbacil use areas are
predominately Hydrologic Group B soils. Hydrologic Group D soils, however,
are a dominate soil type in the sugarcane production area of LA. In comparison
72
-------
to other terbaca use sites, the runoff potential for terbaca is expected to be greater
in the sugarcane production area. Aerial applications of terbacil is limited to mint,
alfalfa, and sugarcane. These uses are expected to pose the greatest drift potential
of terbacil. Based solely on terbacil use data, approximately one-half of the total
terbacil use area is associated with mint production in the Pacific Northwest,
Indiana, and Illinois. Since the Pacific Northwest region is a major production
area which has relatively low rainfall (east of Cascade Mountains), spray drift of
terbacil may be an important route of dissipation in this region (Grant, Yakima,
and Adams Counties in Washington ; Crook and Jefferson Counties hi Oregon).'
Acceptable environmental fate laboratory and field data indicate that
terbacU is persistent (t1/2=653 days) and mobae (£ =54 ml/g) in terrestrial
environments. The predominant routes, of terbaca dissipation are dependent on
microbial-mediated degradation, photodegradation in water, and movement into
ground and surface waters. Since terbaca is expected to move and potentially
accumulate into surface waters, aerobic aquatic metabolism data are needed for a
more complete environmental fate assessment.
Ground and surface water modeling indicates that terbaca can potentially
move into surface waters and shaaow ground water. The available ground and
surface water monitoring data cannot be used to estimate terbaca concentrations
because it is not representative of the terbaca use areas. Therefore, estimated
concentrations are based solely on ground and surface water models. Since
terbaca is used exclusively on minor crops with very localized site conditions, the
Agency concludes the ground and surface water exposure estimates for terbaca are
site specific and, therefore, are not representative of national exposure estimates.
Preliminary surface water modeling indicates that terbacil can move into
surface water at high concentrations. The maximum GENEEC EEC for terbaca
was 154 jig/L for sugarcane, apples, and peaches at application rates of 3 2 Ibs
a.i./A. More refined PRZM-EXAMS modeling indicate terbaca may potentiaay
accumulate in the surface water (e.g., "farm-pond") from year to year. Some
possible reasons for terbaca accumulation in surface water are as foaows: 1.) The
"farm-pond" runoff scenario is a static pond with no adjustment for water outflow
or dilution; and 2.) Aerobic aquatic metabolism was not considered as a route of
dissipation for terbaca in surface water. Since terbaca accumulation in surface
water was observed in surface water modeling, a probabilistic assessment of
terbacil concentration was not conducted. Instead, the 36 year cumulative
PRZM-EXAMS, EECs for terbaca were used as the representative EECs for
sugarcane, apples, and peaches. The cumulative EECs were 1470 /tg/L
forsugarcane in LA, 178 /*g/L for apples in NY, 28 Mg/L for apples in OR, and
63 Mg/L for peaches in GA. These EECs are considered to be very conservative
because they represent 36 years of a continuous cropping regime.
73
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Since the cumulative EECs represent a 36 year accumulation period, a
correction of the cumulative EECs would be needed to determine the annual
accumulation. This type of refinement would allow a direct comparison between
PRZM-EXAMS and GENEEC EECs. Tier II peak EECs indicate the first year
EEC and annual incremental concentration (slope) were 105 and 36 /*g/L for LA
sugarcane; 24 and 4.3 jig/L for NY apples; 0.0 and 0.81 pg/L for GA peaches;
and, 5.2 and 0.52 /tg/L for WA apples . The annual incremental concentration
was derived from the slope of a linear regression models fit to Tier II peak EECs
accumulation over a 36 year computer simulation period. STORET monitoring
data also indicate terbacil was not detected in surface water. There is, however,
uncertainty in the representativeness (or overlap) of the STORET surface water
monitoring data for terbacil use areas. For example, only 5 % of the sugarcane
production area in LA is represented by the STORET monitoring data.
Therefore, most of the surface water monitoring samples in LA were not collected
within the sugarcane production area,
Terbacil exhibits environmental fate properties similar to herbicides
commonly detected in ground water. A generic GW vulnerability screen (GUS)
and more refined PATRIOT modeling indicate that terbacil has a very high
potential to leach into ground water. The GUS comparison score, based solely on
persistence and mobility, exceeds the GUS score of most herbicides commonly
detected in groundwater (e.g., dicambia, fluometuron, atrazine). Based on ground
water vulnerability screening tools, terbacil is expected to be more mobile than
most herbicides commonly detected in ground water (e.g., atrazine, dicamba,
alachlor). PATRIOT modeling suggest that terbacil could reach shallow ground
water (4.5 feet) at high concentrations. SCI-GRO screening model predicts the
maximum chronic concentration of terbacil in shallow groundwater (10 to 30 feet)
is not expected to exceed 125 jtg/L for the majority of the use sites.
Avian species are expected to have minimal acute adverse effects from the
labeled uses of terbacil. Since no chronic data are available for avian species, a
complete chronic avian toxicity assessment cannot be completed at this time.
Avian reproduction studies are necessary because terbacil is a very persistent
herbicide which is applied during the avian reproduction season (early spring).
Additionally, the RQ for chronic adverse effects to mammals at maximum potential
exposure Kenaga values suggest chronic LOG (RQ=1.0) exceedances may occur.
It is generally assumed birds are more sensitive than mammals. Therefore,
chronic toxicity data (71-4 Avian Reproduction Study) for bobwhite quail and
mallard duck are needed for a more complete chronic toxicity assessment of
terbacil.
Minimal acute adverse effects are expected to mammalian species. Since
there are no acute LOG exceedances. However there are chronic exceedances for
74
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mammals (including endangered species) feeding'on short grasses, tall grasses,
broadleaf plants, and insects, at application rates greater than 1.2 Ibs a.i./acre.
The chronic LOC's for mammals are uncertain at this time. The rat
reproductive study shows the NOEL to be higher than the greatest concentration
tested. This concentration is below the maximum and mean predicted residue
values (Kenaga/Fletcher) on mammalian food items. Since the rat reproductive
endpoint is greater than the highest concentration tested, we must use that
concentration level as a default toxic reproductive endpoint. Based on the
Agency's assessment, no evidence of carcinogenicity was detected. The mammal's
chronic feeding toxicity studies indicate there may be increased liver and thyroid
weights at doses between 50 and 250 ppm for dogs, and 1500 ppm for rats. Since
birds generally are more sensitive than mammals to pesticides, the wild mammal
toxicity study (71-3) will be held in reserve pending the review of avian
reproduction studies.
Freshwater aquatic species are expected to have minimal acute adverse
effects from labeled terbacil uses. A chronic risk assessment for aquatic species
can not be made because of insufficient data. Early fish life cycle and aquatic
invertebrate life cycle (72-4) studies are necessary because terbacil is a mobile and
persistent herbicide that may accumulate in surface water bodies.
^ Since estuarine/marine species and freshwater have similar toxicity,
minimar adverse effects are expected. Since terbacil is a persistent and mobile
herbicide with the potential for accumulation in terrestrial environments, it is
, anticipated that non-target plants will be exposed to terbacil via runoff. In
addition, non-target plants are expected to be exposed to terbacil from spray drift
applications on sugarcane, mints, and alfalfa. At all rates of applications, terbacil
can adversely effect non-target plants from a combination of runoff and drift.
Based on the runoff exposure model, the LOG exceedances for channelized runoff
ranges from 15 to 125X. The LOG exceedance for sheet runoff range from 1.5
to 14.6X. The LOG exceedance for spray drift can range from 27.3 to 45.5X and
4.6 to 13.6X for aerial and ground spray application, respectively.
Mitigation options for labeled terbacil uses are associated with rate
reductions (reduce rate from maximum rate to typical rate) coupled with label
advisories for spray drift, groundwater, and surface water. Table 29 below lists
typical terbacil application rates.
75
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Table 29: Typical Terbacil Use Rates
. f f f f vf V> ff *
,,,; ^ f, *,<: '..» >, , :
' - .."•-; '*"£w»< "v ' " , - A
' ,<\v~>, s-< -**'",- i
' t&eSate ', / , f';
' Maxbwsai
^'ITj^ie^ ',.,;
4$i*Bca&*A$ .. ..
Maximum
Alfalfa-AgplicaSoabyAiraswBlias"^fbu,Bfd , ' >
U.S.
NEU.S.
SLN'S: (PA, VA)
(WA, OR) Seedling Alfalfa
(MM) Aerial Use
(OK)
Supplemental Aerial Use
Apples, Peaches-Broadcast and Banded
Asparagus-Broadcast
Blueberries-Broadcast and Banded; Ground Only
Caneberries-Broadcast, Ground Only
Mint-Ground and Air°
M/2LB/A/YR
2 1/4 LB/A/YR
1/2 LB/A/YR
1 1/2. LB/A/YR
1 1/2 LB/A/YR
2 1/4 LB/A/YR
1 1/2 LB/A
4 LB/A/YR
3 LB/A/YR
4 LB/A/YR
2 LB/A/YR
2 LB/A/YR
1 to 1 1/2
1 1/2
1/2 LB
1 1/2 LB
1 1/2 LB
1 1/2-2 LB
1 1/2
2-4*
1.5-2.5"
2-3 LB
2LB
2LB
2
2
2
1
1
2
1
.1
2
1
1
1
*$$$£&"
f
1
1-2
2
1
1
1-2
1
1
1-2
. 1
1
1
Sugarcatte-Briwdcastaad'Baaded, Ground «n.d Air*, -- , ~ - -' - - , " ' ;
(LA)
(TX)
(HD
(PR)
Strawberries-Banded, Ground Only;
Recommended by Supplemental Label Only
4 LB/A/YR
4 LB/A/YR
2 1/2 LB/A
2 1/2 LB/A
1/2 Ib/A
1 1/2-24/10
1-2 LB
1-2 1/2 LB
1-2 1/2 LB
1/2 LB
3
2
1
1
1
2
2
1
1
1
3^bridsPopSEars-Baad^€hx>«ndOaiy ' - .. ,
SLN'S: (OR, WA)
2 LB/A
2LB
1
1
Grass Seed-Broadcast^ Ground Only;. Forage Seserictioa ' " '
SLN (ID)
SLN (OR)
SLN (WA-East of Cascades)
1LB/A
1 1/4 LB/A/YR
1 LB/A/YR
1LB
1 1/4 LB
1LB
1
1
1
1
1
1
'Based on organic matter
bA single use application
"Aerial use is limited
Since terbacil is persistent and mobile herbicide, terrestrial non-target plants can be
adversely impacted from spray drift and runoff at all application rates. Additionally, terbacil
exhibits properties of pesticides commonly detected in surface and ground waters. Analysis of
the usage data indicate that typical application rates of terbacil are generally lower than the
maximum labeled application rates. For example, the typical application rate for sugarcane is
approximately one-third of the maximum application rate. Maximum label application rates
should be more representative of typical application rates. Standard label advisories for spray
drift, ground and surface waters are recommended to alert users of potential environmental
impacts from terbacil. Other mitigation factors taken into account are : 1.) the limited
76
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geographical extent of the current terbacil use area and 2.) Labeled terbacil application rates are
determined according to the soil organic matter content. These factors are expected to limit
potential ground and surface water contamination. However, the use of terbacil on major crops
would require a re-evaluation of the water resource assessment. Specifically, expanded use of
terbacil may trigger the need for a small-scale prospective ground water study and surface water
monitoring.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing terbacil as the active ingredient. The Agency
has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing terbacil. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of terbacil, and lists the. submitted studies that
the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of terbacil and to determine that terbacil can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency, therefore,
finds that all products containing terbacil as the active ingredient are eligible for
reregistration. The reregistration of particular products is addressed in Section V of this
document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of terbacil 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 terbacil, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.
B, Determination of Eligibility Decision
1.
Eligibility Decision
Based on the reviews of the generic data for the active ingredient terbacil,
the Agency has sufficient information on the health effects of terbacil and on its
77
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potential for causing adverse effects in fish, wildlife, and the environment. The
Agency has determined that terbacil products, labeled and used as specified hi this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment. Under the Food Quality Protection Act of
1996, the Agency has determined that a reasonable certainty of no harm will result
to infants and children or to the general population from aggregate exposure to
terbacil. Therefore, the Agency concludes that products containing terbacil for all
uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of terbacil are eligible for
reregistration subject to conditions imposed hi this RED.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for terbacil
issues. Where labeling revisions are imposed, specific language is set forth hi Section V
of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for terbacil meet
the safety standards under the FQPA amendments to section 408(b)(2)(D)
for the general population. In reaching this determination, EPA has
considered available information on aggregate exposures (both acute and
chronic) from non-occupational sources, food and drinking water, as well
as the possibility of cumulative effects from terbacil and other chemicals
with a similar mechanism of toxicity.
Since there are no residential or lawn uses of terbacil, no dermal or
inhalation exposure is expected in and around the home.
In assessing acute dietary risk from food, the endpoint selected was
developmental toxicity. Because the endpoint of concern is a
developmental effect, the only sub-population of concern is females of
child-bearing age (i.e., females, 13+ years old).
In assessing chronic dietary risk from food, EPA estimates that
terbacil residues in food account for 12.2 % of the RfD, based on existing
tolerances and assuming 100% of the crop treated. Incorporating the
results of the Agency's reregistration review (i.e., to revoke tolerances for
78
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citrus fruits and pears, and to raise tolerances on caneberries, blueberries,
peaches, apples, and sugarcane), 4.5% of the RfD is utilized (using
tolerance levels and assuming 100% crop treated).
In assessing aggregate risk, dietary exposures from food and
drinking water were considered. Aggregate acute dietary risk for females
of child-bearing age was calculated and the MOE=1563. Acute dietary
risk from food alone was calculated for females of child-bearing age and
the MOE=4166, (based on tolerance level? reassessed in this RED and
100% crop treated).
In assessing aggregate chronic dietary risk, exposures from food
and drinking water were considered. The aggregate exposures account for
27.6% of the RfD.
In evaluating the potential for cumulative effects, EPA compared '
terbacil with other structurally similar substituted uracil compounds, such
as bromacil and lentacil, and then with other compounds producing similar
effects. A comparison of the available toxicological database for terbacil
and bromacil revealed no clear common mode of toxicity for the chemicals.
The toxicology database for lentacil was not considered because there are
currently no registered uses of lentacil. Based on the available data, the
Agency has determined that there is no clear common mode of toxicity
between terbacil and bromacil.
b. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for terbacil meet
the safety standard under the FQPA amendment to 'section 408(b)(2)(C) for
infants and children. The safety determination for infants and children
considers the factors noted above for the general population, but also takes
into account the possibility of increased dietary exposure due to the specific
consumption patterns of infants and children, as well as the possibility of
increased susceptibility to the toxic effects of terbacil residues ha this
population subgroup.
In determining whether or not infants and children are particularly
susceptible to toxic effects from terbacil residues, EPA considered the
completeness of the database for developmental and reproductive effects,
the nature of the effects observed, and other information.
Based on current data requirements, terbacil has a complete
database for developmental and reproductive toxicity. Because the
developmental NOELs were the same as those for maternal toxicity, and
79
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the NOEL for systemic (parental) toxicity was higher than the NOEL for
reproductive toxicity, these data do not suggest an increased pre- or post-
natal sensitivity of children and infants to terbacil exposure.
Therefore,EPA concludes that the available toxicology data do not support
an uncertainty factor of 1000 as specified in FQPA and that the present
uncertainty factor of 100 is adequate to ensure the protection of infants and
children from exposure to terbacil.
,EPA estimates that terbacil residues in the diet of infants and
children account for 12.8% of the RfD and residues in drinking water
account for 81% of the RfD. Thus, the aggregate exposure from all
sources of terbacil account for 93.8% of the RfD. Therefore, the Agency
concludes that aggregate risks for infants and children resulting from
terbacil uses are not of concern.
In deciding to continue to make reregistration determinations during
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 to its
regulatory determinations. Rather, these early decisions 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 hi this RED are no longer
appropriate, the Agency will consider itself free to pursue whatever action
may be appropriate, including but not limited to reconsideration of any
portion of this RED.
2. Tolerance Reassessment
A summary of the terbacil tolerance reassessment and recommended
modifications in commodity definitions is presented in Table 30.
a. Tolerances Listed Under 40 CFR §180.209(a)
Sufficient data are available to ascertain the adequacy of the
established tolerances on apples, peaches, and sugarcane. The tolerance on
peaches should be increased to 0.2 ppm to reflect the combined limit of
detection for terbacil and its three regulated metabolites (each at 0.05
ppm). Tolerances on apples and sugarcane should be increased to 0.3 ppm
and 0.4 ppm, respectively, based upon the available residue data. Data
80
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from the apple processing study indicate that tolerances are not required for
any regulated processed apple commodity (i.e., apple juice and wet
pomace). The tolerance on pears and citrus fruits will be revoked since
terbacil is no longer used on these commodities
b. Tolerances Listed Under 40 CFR §180.209(b)
Sufficient data are available to ascertain the adequacy of the
established tolerances on caneberries, blueberries, alfalfa (forage and hay),
asparagus, mint, and animal commodities. The tolerance on caneberries
and blueberries should be increased to 0.2 ppm to reflect the combined
limit of detection for terbacil and its three regulated metabolites (each at
0.05 ppm). Data from the mint processing studies also indicate that a
tolerance is not required for mint oil (the only regulated processed
commodity of mint). Additional residue data are required for strawberries.
The available data indicate that tolerances on alfalfa forage and hay
should.be lowered from 5 ppm to 1 and 2 ppm, respectively, and that the
tolerance on asparagus should be increased from 0.2 ppm to 0.4 ppm.
The Agency has determined that residues of terbacil in animal
commodities will be based on CFR part 180.6(a)(3). There is no likelihood
of finite residues of terbacil hi animal commodities once tolerances on
alfalfa forage and hay are reduced to 1 and 2 ppm, respectively. Once the
lower alfalfa tolerances are established, terbacil tolerances on all animal
commodities should be revoked.
Tolerances on pecans, and sainfoin should be revoked as uses on
these commodities have been canceled.
81
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Table 30: Tolerance Reassessment Summary for Terbacil
aa***w» „; . , /,;
<**»g*^
jkJSS^
S&^^U* f':~ '-', '
' , -- ^ " T«terattcesfisteatwaer4&CfB.^iaU09(a)*f
Apples
Citrus fruits
Peaches
Pears
Sugarcane
, , - °
Alfalfa, forage
Alfalfa, hay
Asparagus
Blueberries
Caneberries (blackberries,
boysenberries, dewberries,
loganberries, raspberries, and
youngberries)
Cattle, &t
Cattle, mbyp
Cattle, meat
Goat, fat
Goat, mbyp
Goat, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk, fat (=0.1 ppm in whole
milk)
Mint, hay, peppermint
Mint, hay, spearmint
Pecans
Sainfoin, forage
Sainfoin, hay
Sheep, fat
Sheep, mbyp
Sheep, meat
Strawberries
0.1
0.1
0.1
0.1
0.1
' TofejpaeeS
5.0
5.0
0.2
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1 ,
0.1
0.5
2.0
2.0
0.1
5.0
5.0
0.1
0.1
0.1
0.3
Revoke
0.2
Revoke
0.4
feted tinder 40 CFK4;
1
2
0.4
0.2
0.2
Revoke
2
2
Revoke
Revoke
Revoke
TBD"
The available data indicate that the tolerance should be
increased.
No registered uses.
Tolerance should be increased as the combined LOD for
residues of concern is 0.2 ppm.
No registered uses.
The available data indicate that the tolerance should be
increased.
jSQJlf&ifSj'i ,
The available data support lowering the tolerances on
alfalfa forage and hay.
The available data indicate that the tolerance should be
increased.
If the required data indicate that residues are similar on
blueberries and caneberries. The registrant can propose a
single tolerance for the berries crop group, and separate
tolerances on blueberries and caneberries could be
revoked.
The Agency has determined that terbacil residues in
animal commodities will represent a 180.6(a)(3) situation
once tolerances on alfalfa forage and hay are reduced to 1
and 2 ppm, respectively. Once the lower alfalfa
tolerances are established, terbacil tolerances on all
animal commodities should be revoked.
No registered uses.
No registered uses.
See above comments under cattle.
IR-4 is supporting this use and is currently developing
residue data.
'Since the Agency is recommending that the tolerance expressions be unified to include Terbacil and Metabolites A,
B, and C, these two CFR sections should be combined at the time of tolerance reassessment.
"TBD = To be determined. Tolerance cannot be determined at this time because additional data are required.
82
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c. Codex Harmonization
No Codex Maximum Residue Limits (MRLs) have been established
for terbacil for any agricultural commodity. Therefore, no compatibility
questions exist with respect to U.S. tolerances.
3. Tolerance Revocations and Import Tolerances
Several food/feed uses of terbacil have been voluntarily canceled Once a
pesticide use is no longer registered in the United States, the related pesticide
residue tolerance and/or food/feed additive regulation generally is no longer
needed. It is EPA's policy to propose revocation of a tolerance, and/or food/feed
additive regulation, following the deletion of a related food use from a registration
or following the cancellation of a related food-use registration EPA has the
responsibility under the Federal Food, Drug, and Cosmetic Act (FFDCA) to
revoke a tolerance/regulation on the grounds that the Agency cannot conclude-that
the tolerance/regulation is protective of the public's health.
The Agency recognizes/however, that interested parties may want to retain
a tolerance and/or food/feed additive regulation in the absence of a U S
registration, to allow legal importation of food into the U.S. To assure that all
food marketed in the U.S. is safe, under FFDCA, EPA requires the same technical
chemistry and toxicology. data for such import tolerances (tolerances without
related U.S. registrations) as are required to support U.S. food use registrations
and any resulting tolerances. See 40 CFR Part 158 for EPA's data requirements
to support domestic use of a pesticide and establishment and maintenance of a
tolerance and/or food/feed regulation. In addition, EPA requires residue
chemistry data (crop field trials) that are representative of growing conditions in
exporting countries in the same manner that EPA requires representative residue
chemistry data from different U.S. regions to support domestic use of the pesticide
and the tolerance and/or regulation. Additional guidance on the Agency's import
tolerance policy will be published in an upcoming Federal Register Notice.
Parties interested in supporting an existing terbacil tolerance as an import
tolerance should ensure that all of the data noted above are available to EPA during
its further assessments of existing tolerances and regulations, so that the Agency
may determine whether maintenance of the tolerance and/or regulation would be
protective of the public's health.
4. Ecological Effects
Minimal adverse acute effects are expected for avian, mammalian and
aquatic species from labeled uses of terbacil. Chronic effects for avian and "aquatic
species cannot be evaluated at this time because of insufficient data However
83
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chronic RQs for mammals indicate that adverse effects are possible from labeled
uses of terbacil. There is some uncertainty in assessing adverse chronic
mammalian effects because the NOEL is greater than the maximum concentration
tested in rat reproduction study design. Therefore, the highest concentration is a
default toxicity endpoint which is a conservative estimate of risk. Since terbacil
is a persistent and mobile herbicide, non-target terrestrial plants are expected to
be adversely affected from runoff and spray drift. Minimal adverse effects,
however, are expected for non-target aquatic plants^ Because terbacil is used
exclusively on minor crops, terbacil exposure is expected to be very localized and
dependent on site specific conditions. The localized nature of terbacil use areas is
expected to limit human and ecological exposure.
5. Endangered Species Statement
The Agency has developed a program (the "Endangered Species Protection
Program") to identify pesticides whose use may cause adverse impacts on
endangered and threatened species, and to implement mitigation measures that will
eliminate the adverse impacts. At present, the program is being implemented on
an interim basis as described in a Federal Register Notice (54 FR 27984-28008,
July 3,1989), and is providing information to pesticide users to help them protect
these species on a voluntary basis. As currently planned, the final program will
call for label modifications referring to required limitations on pesticide uses,,
typically as depicted ha county-specific bulletins or by other site-specific
mechanisms as specified by state partners. A final program, which may be altered
from the interim program, will be described hi a future Federal Register Notice.
The Agency is not imposing label modifications at this time through the RED.
Rather, any requirements for product use modifications will occur hi the future
under the Endangered Species Protection Program.
6.
Surface Water
The Agency recommends a surface water label advisory on terbacil because
it has characteristics (persistent and very mobile) of pesticides (e.g. atrazine, etc.)
hi surface waters. Surface water modeling for a Louisiana sugarcane scenario
indicate terbacil may accumulate at concentrations greater than 1 mg/L. Since
terbacil is used on vulnerable soils for surface water contamination such as the
Louisiana production area, a surface water label advisory is required. The label
advisory must state: "Terbacil has properties that may result in surface water
contamination via dissolved runoff and runoff erosion. Practices should be
followed to minimize the potential for dissolved runoff and/or runoff erosion."
7.
Ground Water
Terbacil is more mobile and persistent than a number of herbicides which
have been found to contaminate ground water. EPA recommended a ground water
label advisory be placed on the terbacil label hi 1989 and in 1995. The Agency
84
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continues to recommend a ground water label advisory. The following label
language is appropriate: "This chemical has properties and characteristics
associated with chemicals detected in ground water. The use of this chemical in
areas where soils are permeable, particularly where the water table is shallow,
may result in ground-water contamination."
Ground and surface water monitoring studies for terbacil are not considered
necessary at this time and are placed in reserve. If terbacil .use should expand in
the future or the use pattern changes significantly, a small-scale prospective study
or a limited monitoring program may become necessary. Additionally, a surface
water monitoring program may be needed with expanded use on major crops.
8. Occupational Labeling Rationale/Risk Mitigation
a. 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 within the scope of the WPS. Uses
within the scope of the WPS include all commercial (non-homeowner) and
research uses on farms, forests, nurseries, and greenhouses to produce
agricultural plants (including food, feed, fiber plants, trees, turfgrass,
flowers, shrubs, ornamentals, and seedlings). Uses within scope include
not only uses on plants, but also uses on the soil or planting medium the
' plants are (or will be) grown in.
All currently registered uses of terbacil are within the scope of the
Worker Protection Standard for Agricultural Pesticides.
b. Personal Protective Equipment/Engineering Controls for
Handlers
(1) Occupational-Use Products
For each end-use product, PPE/engineering control
requirements for pesticide handlers will be set during reregistration
in one of two ways:
1. If EPA determines that no regulatory action must be taken
as the result of the acute effects or other adverse effects of
an active ingredient, the PPE for pesticide handlers will be
' based oh the acute toxicity of the end-use product. For
occupational-use products, PPE will be established using the
85
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c.
process described in PR Notice 93-7 or more recent EPA
guidelines.
2. If EPA determines that regulatory action on an active
ingredient must be taken as the result of very high acute
toxicity or certain other adverse effects, such as allergic
effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc):
* In the RED for that active ingredient, EPA may
establish minimum or "baseline" handler PPE or
engineering-control requirements that pertain to all
or most occupational end-use products containing
that active ingredient.
* These minimum PPE requirements must be
compared with the PPE that would be designated on
the basis of the acute toxicity of each end-use
product.
* The more stringent choice for each type of PPE
(i.e., bodywear, hand protection, footwear,
eyewear, etc.) must be placed on the label of the
end-use product.
The Agency has determined that there are no special
lexicological concerns about terbacil to warrant the establishment
of active-ingredient-based handler PPE/engineering-control
requirements. Handler PPE requirements for terbacil products are
to be based on the acute toxicity of individual end-use products.
(2) Homeowner Use Products
There are no homeowner uses registered for terbacil.
Post-Application/Entry Restrictions
(1) Restricted Entry Interval
Under the Worker Protection Standard (WPS), interim
restricted entry intervals(REIs) for all uses within the scope of 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
86
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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 H, 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 REIs
established by the Agency prior to the promulgation of the WPS:
(1) product-specific REIs established on the basis of adequate data,
and (2) interim REIs that are longer than those that would be
established under the WPS. .
i •
The interim WPS REI in effect until now for occupational
use products that contain terbacil and are within the scppe of the
WPS is 12 hours. During the reregistration process EPA found no
reason to lengthen the previously established REI.
(2) Early Entry PPE
The WPS establishes very specific restrictions on entry by
workers to areas that remain under a restricted-entry interval if the
entry involves contact with treated surfaces. Among those
restrictions are a prohibition of routine entry to perform hand labor
tasks and the requirement that personal protective equipment be
worn. Personal protective equipment requirements for persons
who must enter areas that remain under a restricted-entry interval
are based on the toxicity concerns about the active ingredient. The
requirements are set in one of two ways.
1.
2.
If EPA determines that no regulatory action muk be taken
as the result of the acute or other adverse effects of an
active ingredient, it establishes the early-entry PPE
requirements on the basis of the acute dermal toxicity, skin
irritation potential, and eye irritation potential of the active
ingredient.
If EPA determines that regulatory action on an active
ingredient must be taken as the result of very high acute
toxicity or to certain other adverse effects, such as allergic
effects or delayed effects (cancer, developmental toxicity,
reproductive effects), it. may establish early-entry PPE
87
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d.
requirements that are more stringent than would be
established otherwise.
Terbacil is classified as category IV for acute oral, acute
dermal and dermal irritation, and category III for acute inhalation
toxicity and for eye irritation. EPA has determined that no
regulatory action must be taken due to acute effects or other adverse
effects of terbacil. Therefore the PPE required for early entry is the
rninimum early-entry PPE permitted under the WPS: coveralls,
chemical-resistant gloves, shoes and socks.
(3) WPS Double Notification Statement
The WPS double notification requirement is imposed if the
active ingredient is classified as toxicity category I for acute dermal
toxicity or skin irritation potential. Since neither of these
classifications apply to terbacil, double notification is not required
for terbacil end-use products.
(4) Entry Restrictions for Occupational-Use Products (Non-
WPS Uses)
There are no non-WPS uses registered for terbacil.
Other Labeling Requirements
For the specific labeling statements, refer to Section V of this
document.
9. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop the
best spray drift management practices. The Agency is now requiring interim
measures that must be placed on product labels/labeling as specified in Section V.
Once the Agency completes its evaluation of the new data base submitted by the
Spray Drift Task Force, a membership of U.S. pesticide registrants, the Agency
may impose further refinements in spray drift management practices to further
reduce off-target drift and risks associated with this drift.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
88
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A. Manufacturing-Use Products
,1. Additional Generic Data Requirements
The generic data base)supporting the reregistration of terbacil for the above
eligible uses has been reviewed and determined to be substantially complete. The
following studies are required to be conducted on the generic active ingredient.
Aerobic Aquatic Metabolism [162-4]
Avian Reproduction Quail [71-4(a)J -
Avian Reproduction Duck [71-4(b)]
Early Life-Stage Fish [72-4(a)]
Life-Cycle Aquatic Invertebrate [72-4(b)]
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be, revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into a herbicide for the following use(s) [terrestrial
food/feed crops (e.g., apples, mint/peppermint, and sugarcane), forestry
(e.g., cottonwood (forest/shelterbelt), terrestrial food (e.g., asparagus,
blackberry, boysenberry, dewberry, loganberry, peach, raspberry'
youngberry and strawberry), and terrestrial feed (e.g., alfalfa, sainfoin
(hay and fodder), and forage)] being supported by MP registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the reformulation
of the product for a specific use or all additional uses supported by a formulator
or user group:
(a) "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)."
(b) "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)." ,
Other labeling requirements include:
89
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(a) Maximum label application rates should be reduced to be
representative of typical application rates. Table 31 below lists
typical terbacil application rates.
Table 31; Typical Terbacil Use Rates
, *',ZJrv> /- < '.
•, 1*,,*&',',':\ '0*8^' - '- „„ ~i
, - ~r«< *,*-;*-,- , <;..;% , ; ',' ' \
Alfalfa-Application by Air as well as ground
U.S.
NEU.S.
SLN'S: (PA, VA)
(WA, OR) Seedling Alfalfa
(NM) Aerial Use
(OK)
Supplemental Aerial Use
Apples, Peaches-Broadcast and Banded
Asparagus-Broadcast
Blueberries-Broadcast and Banded; Ground Only
Caneberries-Broadcast, Ground Only
Mint-Ground and Air0
Sugarcane-Broadcast and Banded,
Ground and Air1
(LA)
CTX)
(HI)
(PR)
Strawberries-Banded, Ground Only; Recommended by
Supplemental Label Only
Hybrid Poplars-Banded Ground Only
SLN'S: (OR, WA)
Grass Seed-Broadcast; Ground Only; Forage Restriction
SLN (ID)
SLN (OR)
SLN (WA-East of Cascades)
; tfeeltafe
'"Mwfowm "\
1 1/2 LB/A/YR
2 1/4 LB/A/YR
1/2 LB/A/YR
1 1/2 LB/A/YR
1 1/2 LB/A/YR
2 1/4 LB/A/YR
1 1/2 LB/A
4 LB/A/YR
3 LB/A/YR
4 LB/A/YR
2 LB/A/YR
2 LB/A/YR
4 LB/A/YR
4 LB/A/YR
2 1/2 LB/A
2 1/2 LB/A
l/21b/A
2 LB/A
1LB/A
1 1/4 LB/A/YR
1 LB/A/YR
typteH.
1 to 1 1/2
11/2
1/2 LB
1 1/2 LB
11/2LB
1 1/2-2 LB
1 1/2
2-4'
1.5-2.5"
2-3 LB
2LB
2LB
1 1/2-
24/10
1-2 LB
1-2 1/2 LB
1-2 1/2 LB
1/2 LB
2LB
1LB
1 1/4 LB
1LB
'%PJw8tl
-------
should be followed to minimize .the potential for dissolved runoff
and/or runoff erosion."
(c) '"This chemical has properties and characteristics associated with
chemicals detected in ground water. The use of this chemical in
areas where soils are permeable, particularly where the water table
is shallow, may result in ground-water contamination."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria and if not, commit to conduct new studies.
If a registrant believes that previously submitted data meet current testing
standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each
product.
2. PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain terbacil, the
product labeling must be revised to adopt the handler personal protective
* equipment requirements set forth in this section. Any conflicting PPE requirements
on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain terbacil, the
handler personal protective equipment requirements set forth in this section must
be compared to the requirements on the current labeling and the more protective
must be retained. For guidance on which requirements are considered more
protective, see PR Notice 93-7.
a. Minimum PPE/Engineering Control Requirements
EPA is not establishing active ingredient-specific PPE or
engineering control requirements for terbacil end-use products.
b. Actual end-use product PPE requirements
Any necessary PPE for each terbacil occupational end-use product
will be established on the basis of the end-use product's acute toxicity
category.
91,
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c. Placement in labeling
The personal protective equipment must be placed on the end-use
product labeling in the location specified in Pk Notice 93-7 and the format
and language of the PPE requirements must be the same as is specified in
PR Notice 93-7.
3. Entry Restrictions
For sole-active-ingredient end-oise products that contain terbacil the
product labeling must be revised to adopt the entry restrictions set forth in this
section. Any conflicting entry restrictions on the current labeling must be removed.
i \
For multiple-active-ingredient end-use products that contain terbacil the
entry restrictions set forth in this section must be compared to the entry restrictions
on the current labeling and the more protective must be retained. A specific time-
period in hours or days is considered more protective than "sprays have dried" or
"dusts have settled."
a. Restricted-entry interval
A 12-hour restricted-entry interval (REI) is required for uses within
the scope of the WPS on all terbacil end-use products.
b. Early-entry personal protective equipment (PPE)
The PPE required for early entry to treated areas that is permitted
under the Worker Protection Standard arid that involves contact with
anything that has been treated, such as plants, soil, or water, is:
Coveralls over short-sleeve shirt and short pants
Chemical-resistant gloves
Shoes and socks
c. Placement in labeling
The REI must be inserted into the standardized REI statement
required by Supplement Three of PR Notice 93-7. The PPE required for
early entry must be inserted into the standardized early-entry PPE
statement required by Supplement Three of PR Notice 93-7.
4. Spray Drift Labeling
The following aerial drift reduction advisory information must be contained
in the product labeling:
92
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AERIAL SPRAY DRIFT MANAGEMUCT
Drift at the Application Site js €he Responsibility of the Applicator,
The interaction qf sway eq^tae»t-and-weatfeeT-i»lated factors detgrjuia& tie' potential' for spray
drift. The applicator is responsible for considering all these factors when making decisions.
,'"' " ,« •> ^ '" w' , s ^ '
The following dri& management abatements must be followed to avoid off-targei movement
from'aerial applcations to agricultural field crops. These regmrements do not apply to forestry
=,-publicnealth^ses or to—«—-«--'- * < - •
the distaape of fh^oitfer most Rozzjies oa the boom nmst not exceed 3/4 the leagth &£ the
or rotor. ' % i- - ^ — -
ys pbmt bacfewad parallel with ike air streasa and never' be poimed
more ffcam 45 degrees '\ % ^ "
Where slates nave
^
'
e applicator snoidd be familkr with and-tate kto'accoaat the'informatioii covered in.
the- Aeiial Drilt Rectedfoa Advisory^ , - - '.. - ,
5. . Other Labeling Requirements
The Agency is requiring the following labeling statements to be located on
all end-use products containing terbacil that are intended primarily for occupational
use,
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."
User Safety Requirements:
"Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product's concentrate.
Do not reuse them. Follow manufacturer's instructions for
cleanmg/maintaining PPE. If no such instructions for washables,
93
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use detergent and hot water. Keep and wash PPE separately from
other laundry."
User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
• "Users should remove PPE immediately after handling this product.
As soon as possible, wash thoroughly and change into clean
clothing."
Engineering Controls:
"When handlers use closed systems, or .enclosed cabs or aircraft in a
manner that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the
handler PPE requirements may be reduced or modified as specified in the
WPS."
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).
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.
94
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• 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.
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.
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.
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.)
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.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to
produce larger droplets to compensate for evaporation. Droplet
evaporation is most severe when conditions are both hot and dry.
95
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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.
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).
6. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this
Reregistration Eligibility Decision (RED). Persons other than the
registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell
terbacil products bearing old labels/labeling for 26 months from the date
of issuance of this RED. Persons other than registrant may distribute or
sell such products for 50 months from the date of the issuance of this
RED. Registrants and persons other than registrants remain obligated to
meet pre-existing Agency imposed label changes and existing stock
requirements applicable to products they sell or distribute.
96
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VI. APPENDICES
97
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. GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case TERBAGIL covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to TERBACIL hi all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 GFR Part 158. the reference numbers accompanying each test refer to the test
protocols set hi the Pesticide Assessment Guidelines, 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.
109
-------
110
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of
TERBACIL
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-2A
61-2B
62-1
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-11
63-12
63-13
63-17
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
PH
Stability
Storage stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42199001, 00012366, 00142302
42199001, 00012366
00012364, 00067336, 00142302
00011958
00011958
00011958
00011958
42335302, 00011958
00011958
42335303,00011958
00125692
42335302
42335301
42335301
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - ALL
Quail/Duck
71-2A Avian Dietary - Quail ALL
72-1A Fish Toxicity Bluegill ALL
72-1C Fish Toxicity Rainbow Trout ALL
72^2A Invertebrate Toxicity ALL
72-3A Estuarine/Marine Toxicity - AB
Fish
00157177
00012346, 00012347, 241146
00390019, 00025224
00390017, 00025223, 44150201
00390018, 249455,125705
41896101, 41896100
111
-------
Data Supporting Guideline Requirements for the Reregistration of
TERBACIL
REQUIREMENT
USE PATTERN
CITATION(S)
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
123-1A Seed Germination/Seedling
Emergence
123-1B Vegetative Vigor
123-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity -
Rat
81-4 Primary Eye Irritation -
Rabbit
81-6 Dermal Sensitization -
Guinea Pig
82-1A 90-Day Feeding - Rodent
82-1B 90-Day Feeding - Non-rodent
82-2 21-Day Dermal - Rabbit/Rat
83-1A Chronic Feeding Toxicity -
Rodent
83-1B Chronic Feeding Toxicity -
Non-Rodent
83-2A Oncogenicity - Rat
AB 00012332,00012333
AB
00012332
ALL 43895801,42336701
ALL 43895801,42336701
ALL 43929802, 43909802, 42306101,
43929801
AB 00018842
ALL 00150946,114693, 24955
ALL 00130945,114693, 24955
ALL 00125700
ALL 00157179
ALL 00157180
ALL 00068035,00039009
ALL 00060851
ALL 00125785,00148006
AB 42987601
AB 00060851
AB 42987601
112
-------
Data Supporting Guideline Requirements for the Registration of
TERBACIL
REQUIREMENT
USE PATTERN
CITATIONS
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity -
Rabbit
83-4 2-Generation Reproduction -
Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other GenotoxicEffects
85-1 General Metabolism
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorpt
ion
164-1 Terrestrial Field Dissipation
165-2 Field Rotational Crop
165-4 Bioaccumulation in Fish
AB 42031601,00126770
ALL 00050467,00039001
ALL 00150945
ALL 00060852
ALL 00155103,00150943
ALL 00157181,00150944
ALL 00150939,00155103
AB 40104702
ALL 0001946,41136301
ALL 00011946
ALL 001600235
ALL 05024336, 05013204, 05016176,
42369901
ALL 42370001,05024336,05013204,
05016176
ALL 05013202,42335401,00155104,
05014424, 05008371, 05014175
ALL 43585500, 05017062, 05014421
AB 42369901
ALL 00011947
113
-------
Data Supporting Guideline Requirements for the Reregistration of
TERBACIL
REQUIREMENT
USE PATTERN
CITATION(S)
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method -
Plants
171-4E Storage Stability
Nongrass Animal Feeds
-Alfalfa forage & hay
Pome Fruits Group
-Apples
ALL 44080101, 43909801, 00011965,
00012014, 05002415, 05013194,
05013216, 05013598
ALL 42809401, 42717101, 00011950,
00011957
ALL 42740301, 42740302, 42740303,
42740304,42465202
ALL 00011952,00150369,42885201
AB 00011959, 00130415, 00144089,
00149202, 42335601
AB 44048901, 00070784, 00012015,
00012402, 00149184, 00157178
Miscillaneous Commodities
-Asparagus
-Mint hay/Peppermint
-Surgarcane
Berries Group
-Blueberries
-Caneberries
-Strawberries
AB 00028524,42465201
AB 00012067, 00012103, 42335501
AB 00012179, 00012180, 00157178,
44048903
AB 00012039, 05013352, 44177101
AB 05015405, 00390015, 44177102
AB 00012097
. Stone Fruits
-Peaches
AB
00012402, 00128574, 00149184
114
-------
Data Supporting Guideline Requirements for the Registration of
TERBACIL
REQUIREMENT
USE PATTERN
CITATIONS
Grass Grown Soley for Seed
-Grass Forage/Fodder/Hay
AB
42692501
171-4L Processed Food
-Apples
-Mint
-Sugarcane
AB 00012067,44048902
AB 00012067, 00012103, 42345201
AB 00012179, 00012180, 44048904
115
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116
-------
GUIDE TO APPENDIX C
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 suppdrt of past regulatory decisions. Selections from other sources
including the published literature, hi those instances where they have been considered,
are included. • •* •
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. '
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.
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 np 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 contained hi the document. When the date appears
117
-------
as (19??), the Agency was unable to determine or estimate the date of the document.
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.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (hi 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 hi 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.
118
-------
BIBLIOGRAPHY
MRID
CITATION
00003401
00011946
00011947
00011950
00011965
00012015
00012039
00012067
00012097
Gessert, R. (EPA Memorandum to R., Taylor) re: upgrading of data from 3-
generation rat reproductive study. January 20, 1983.
Rhodes, R.C. (1975) Biodegradation Studies with 2-14C-Terbacil in Water and
Soil. (Unpublished study received Nov 25, 1975 under 4F1428; prepared in
cooperation with Univ. of Delaware, College of Agricultural Sciences,
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del •
CDL:094842-A)
Rhodes, R.C. (1969?) Four Week Residue Studies with 2-14C-Terbacil and
Bluegill Sunfish. (Unpublished study received Nov 25, 1975 under 4F1428;
prepared in cooperation with Cannon Laboratories, Inc., submitted by E.I. du '
Pont de Nemours & Co., Inc., Wilmington, Del,; CDL:094842-B)
Han, J.C. (1973?) 2-14C-Terbacil Goat Metabolism Study. (Unpublished study
received Oct 1, 1974 under 4F1428, submitted by E. I. du Pont de Nemours &
Co., Inc., Wilmington, Del.; CDL:093805-B)
\
Rhodes, R.C. (1964?) Studies with 14C-Labeled Terbacil in Alfalfa.
(Unpublished study received Aug 30, 1973 under 4F1428; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:093806-J)
E.I. du Pont de Nemours and Company (1966) Results of Tests on the Amount
of Residue in Crops Grown on Treated Soil. (Unpublished study received Dec
13, 1966 under 6F0510; CDL:090603-N)
IR-4 Project at Rutgers, the State University (1973) Results of Tests on the
Amount of Residue Remaining on Treated Blueberries: (Terbacil).
(Unpublished study received Dec 19, 1975 under 6E1719; prepared in
cooperation with DuPont Co.; CDL:095364-A)
E.I. du Pont de Nemours & Company (1975) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Terbacil]. (Unpublished study received
Dec 3, 1975 under 6F1713; CDL:095184-C)
IR-4 Project at Rutgers, the State University (1972) Analytical Residues:
(Terbacil). (Unpublished study received Mar 14, 1977 under 7E1936-
CDL:097354-A)
119
-------
BIBLIOGRAPHY
MRID
CITATION
00012103 E.I. du Pont de Nemours and Company (1966) Results of Tests on the Amount
of Residue in Crops Grown on Treated Soil: [Terbacil]. (Unpublished study
received Nov 16, 1966 under 7F0549; CDL:092838-B)
00012179 E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer Residue
Data—Sugar Cane: Supplemental Information. (Unpublished study received
Apr 13, 1966 under unknown admin, no.; CDL:124198-A)
00012180 E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer (3-
—Aiterfyt—Butyl-5-cMoro-6-methyluracil) Residue Data—Sugar Cane.
(Unpublished study received Feb 9, 1966 under unknown admin, no.;
CDL:124200-A)
00012332 Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de Nemours &
Co.: Sinbar Terbacil Weed Killer, 80% Wettable Powder: Acute Toxicity of
H-8309 to Grass Shrimp 0* ~ Palaemonetes vul ~ jt-ji ~ garisju. ~ ) and Fiddler
Crab Oi~Uca pugilator/i-). (Unpublished study received Apr 11, 1974 under
352-17; prepared by Bionomics, Inc., submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL: 129203-B)
00012333 Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de Nemours &
Company, Newark, Delaware: Sinbar Terbacil Weed Killer, 80% Wettable
Powder: Acute Toxicity of H-8309 to Atlantic Oyster 0*~Crassostrea
virginica/i~). (Unpublished study received Apr 11, 1974 under 352-317;
prepared by Bionomics, Inc., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:129203-C)
00012346 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in Wildfowl
(Pheasant Chick). (Unpublished study received on Jan 11, 1978 under 352-317;
prepared by International Research and Development Corp., submitted by E.I.
du Pont de Nemours & Co., Wilmington, Del.; CDL:096709-B)
00012347 . Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in Wildfowl
(Pekin Duckling). (Unpublished study received on Jan 11, 1978 under
352-317; prepared by International Research and Development Corp.,
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:096709-C)
120
-------
BIBLIOGRAPHY
MRID
CITATION
00012364
00012366
00012402
00013286
00012424
00013287
00013288
E.I. du Pont de Nemours and Company (19??) Composition of Technical
Terbacil: Active Ingredient in Sinbar Weed Killer. (Unpublished study
received Nov 7, 1978 under 352-317; CDL:235690-A)
E.I. duPont de Nemours and Company (19??) Purity of Starting and
Intermediate Materials Used in the Terbacil Manufacturing Process.
(Unpublished study received Nov 7, 1978 under 352-317; CDL: 235690-C)
E.I. du Pont de Nemours & Company (1973) Daja Supporting the Use of
Zobar*Weed Killer in Established Apples and Peaches. Summary of studies
026721-B through 026721-Y. (Unpublished study received Oct 17, 1973 under
352-374; CDL:026721-A)
Yamane, G.M. (1968) Crop Tolerance for Hyvar X, DuPont 732, and DuPont
767 Experimental Herbicides. (Unpublished study received Mar 24, 1970
under 352-287; prepared by Pineapple Research Institute, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:00 E.I. du Pont de Nemours
& Co., Wilmington, Del.; CDL:026721-X)
Ratto, D.B. (1972) To Test Zobar I & Zobar 21 for Weed Control in Apples.
(Unpublished study received Oct 17, 1973 under 352-374; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:026721-Y)
Yamane, G.M. (1968) Crop Tolerance for Hyvar X, DuPont 732, and DuPont
767 Experimental Herbicides. (Unpublished study including incomplete letter
dated Jan 4, 1967 from G.M. Yamane to Wayne D. Grogg and letter dated Jul
29, 1968 from M.F. O'Brien to Don L. Bufgoyne, received Mar 24, 1970
under 352-287; prepared by Pineapple Research Institute in cooperation with
Dole Co. and Hawaiian Fruitpackers, submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:002922-I)
Yamane, G.M. (1968) Soil Persistency of Hyvar X. Rev. (Unpublished study
including letter dated May 3, 1968 from D.L, Burgoyne to H.L. Pease,
received Mar 24, 1970 under 352-287; prepared by Pineapple Research
Institute, submitted by E.I. du Pont de Nemours & Co., Wilmington Del •
CDL:002922-K) . ' "
121
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BIBLIOGRAPHY
MRID
CITATION
00017711 Liu, L.C.; Cibes-Viade, H.R.; Gonzalez-Ibanez, J. (19??) Persistence of
several herbicides in a soil cropped to sugarcane. Journal of Agriculture of
University of Puerto Rico ? (? ):147-152. (Also-In-unpublished submission
received Aug 20, 1976 under 39445-1; submitted by American Carbonyl, Inc.,
Tenafly, N.J.; CDL:228229-Y)
00025223 McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbicil Weed Killer: Toxicity to
Rainbow Trout]: Test No. 520. (U.S. Environmental Protection Agency,
Pesticides Regulation Div., Agricultural Research Center, Animal Biology
Laboratory, unpublished report.)
00025224 McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbacil Weed Killer: Toxicity to
Bluegill Fish]: Test No. 515. (U.S Environmental Protection Agency,
Pesticides Regulation Div., Agricultural Research Center, Animal Biology
Laboratory, unpublished report.)
00028135 Isom, W.H.; Ford, H.P.; Lavalleye, M.P.; et al. (1969) Persistance [sic] of
Herbicides hi Irrigated soils. (Unpublished study received Aug 20, 1976 under
39445-1; prepared by Sandoz-Wander, Inc., submitted by American Carbonyl,
Inc., Tenafly, N.J.; CDL:228229-X)
00028524 Interregional Research Project Number 4 (1976) (Terbacil Residue Data
Summary: Asparagus). (Unpublished study received Jun 11, 1980 under
OE2371; CDL:099449-A)
00039001 Haskell Laboratories, Rat Oral Teratology with Terbacil, received February
20, 1980, submitted by E.I. du Pont de Nemours & Company, Inc.,
Wilmington, Del.
00039009 Haskell Laboratoris, Rat 90-day feeding study hi Rats, received June 28, 1965,
submitted by E.I. du Pont de Nemours 7 Company, Inc., Wilmhigton, Del.
00060851 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Two-Year Feeding Study in
the Dog: IRDC No. 125-011. (Unpublished study received Apr 4, 1967 under
6F0510; prepared by International Research and Development Corp., submitted
by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:090602-A;
090600)
122
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BIBLIOGRAPHY
MRID
CITATION
00060852
00067336
00068035
00070784
00114693
00125700
00125705
00125785
Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Three-Generation
Reproduction Study in. the Rat: IRDC No. 125-012. (Unpublished study
received Apr 4, 1967 under 6F0510; prepared by International Research and
Development Corp., submitted by E.I. du Pont de Nemours & Co., Inc;,
Wilmington, Del.; CDL:090602-B; 090600)
Karrh, B.W. (1976) Letter sent to John E. Moss dated Oct 4, 1976 [Results of
analyses of du Pont pesticides for dimethylnittosamines (DMN)]. (Unpublished
study received.Dec 8, 1976 under 352-378; submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:230783-A)
Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1964) Ninety-day Feeding Study in
the Rat: IRDC No. 125-004. (Unpublished study received May 20, 1981 under
352-317; prepared by International Research and Development Corp.,
submitted by E.I. du Pont de Nemours & Co., Wilmington Del •
CDL:245112-D)
Stauffer Chemical Company (1980) DevrinolA(R)=4-F Selective Herbicide:
Summary of Crop Residue Data on Apples, Peaches, and Cit rus.
(Compilation; unpublished study received Dec 11, 1980 under 476-2199-
CDL:243860-A)
Haskell Laboratories, 14-day Rat Feeding Study, received June 25, 1965,
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.
Burgess, B.; Ferenz, R.; Koechert, M. (1982) Inhalation Median Lethal
Concentration (LC50): [IND-732-38]: Haskell Laboratory Report No. 351-82.
(Unpublished study received Qct 9, 1982 under 352-317; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, DE; CDL:249455-J)
Phillips, F.; Hall, C. (1981) 48-hour LC50 to Daphnia magna: [Terbacil]:
Haskell Laboratory Report No. 392-81. (Unpublished study received Oct 9,
1982 under 352-317; submitted by E.I. du Pont de Nemours & Co Inc
Wilmington, DE; CDL:249455-O) ,
Hood, D. (1966) 15-exposure Skin Absorption Studies with 3-tert-Butyl-5-
chloro-6-methyluracil: Report No. 33-66. (Unpublished study received Feb 15,
1983 under 352-317; submitted by E.I. du Pont de Nemours & Co., Inc.
Wilmington, DE; CDL:249517-A) " ,
123
-------
BIBLIOGRAPHY
MRID
CITATION
00126770 Goldenthal, E.; Roman, S.; Richter, W. (1981) 2-year Feeding Study in Mice:
[Terbacil]: 125-027. (Unpublished study received Apr 5, 1983 under 352-247;
prepared by International Research and Development Corp., submitted by E.I.
du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:249907-A; 249908;
249906) '
00130415 E.I. du Pont de Nemours & Co., Inc. (1983) Residue Data: (Terbacil and
Others on Alfelfa). (Compilation; unpublished study received 1983 under
352-317; CDL:251051-B)
00130945 Hood, D. (1965) Acute Skin Absorption Toxicity: [3-tert-Butyl-5-chloro-
6-methyluracil: Rabbits]: Haskell Laboratory Report No. 76-65. (Unpublished
study received May 1, 1981 under unknown admin, no.; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, DE; CDL:251081-C)
00138467 E.I. du Pont de Nemours & Co., Inc. (1979) 96-Hour LC50 to Bluegill
Sunfish: OUracil: Haskell Laboratory Report No. 701-78. (Unpublished study
received Oct 16, 1979 under 352-317; CDL: 241146-A)
00142302 E. I. du Pont de Nemours and Co., Inc. (1984) "Product Chemistry to Support
Terbacil Reregistration". Unpublished study. 27 p.
00144089 E.I. du Pont de Nemours and Co., Inc. (1984) Residue Data to Support
Terbacil and Its Metabolities on Alfalfa at the Increased Maximum Rate of 2
Lb/a/Yr by Split Application int he Northeast U.S. Unpublished compilation.
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Terbacil by Gavage in the Rabbit: Medical Research Project No. 4512-001:
Haskell Report No. 528-83. Unpublished study pre pared by E.I. du Pont de
Nempurs & Co., Inc., Haskell Laboratory for Toxicology and Industrial
Medicine. 73 p.
00150946 Cortina, T. (1984) Acute Oral Toxicity Study hi Rats: H #14,673: Final
Report: Project No.: 201-713. Unpublished study prepared by Hazleton
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Haskell Lab. Report No. 9-80: No. 058-783. Unpublished Review. 4 p.
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capricornutum Printz: Lab Project Number: AMR-1860-90. Unpublished study
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Metal Ions, in Sunlight and at Normal and Elevated Temperatures: Lab Project
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[carbon 14] Terbacil: Lab Project Number: AMR 2154-91: 1396: 597.
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Lee, P. (1992) Magnitude of Terbacil Residues in Mint Hay after Sinbar
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Oil after Sinbar Herbicide Application: Lab Project Number: AMR 1994-91.
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PTRL-West. 80 p.
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[carbon 14]-Terbacil: Lab Project Number: AMR 1689-90: 1403: 449.
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[carbon 14] Terbacil: Lab Project Number: AMR1688-90: 1392: 450.
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Quantitation of Terbacil and its Metabolites in Mint, Apple, Sugarcane and
Blueberries: Lab Project Number: AMR 1719-90: 234W-1: 234-W.
Unpublished study prepared by Pharmacology and Toxicology Research
Laboratory-West, Inc. 36 p.
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Screening, and Straw Following Applications of Sinbar Herbicide to Grass Seed
Crops: Lab Project Number: AMR 2138-92: 350W-1. Unpublished study
prepared by E.I. du Pont de Nemours and Co. and PTRL-West. 187 p.
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Goat: Lab Project Number: AMR-1979-91: 1335: 539. Unpublished study
prepared by PTRL East, Inc. 106 p.
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Protocols A through E: Terbacil: Lab Project Number: AMR-1836-90:
DP004-01. Unpublished study prepared by Spectralytix, Inc. 64 p.
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Protocols A through E: Terbacil: Lab Project Number: AMR-1837-90:.
DP004-02. Unpublished study prepared by Spectralytix, Inc. 64 p.
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Protocols A through E: Terbacil: Lab Project Number: AMR-1838-90:
DP004-03. Unpublished study prepared by Spectralytix, Inc. 64 p.
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Protocols A through E: Terbacil: Lab Project Number: AMR-1839-90:
DP004-04. Unpublished study prepared by Spectralytix, Inc. 64 p.
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Following Oral Administration for 5 Consecutive Days: Lab Project Number:
AMR 2330-92: 1486: 665. Unpublished study prepared by PTRL East, Inc.
114 p.
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Terbacil and its Metabolites (A,B, and C) in Apples, Mint, Sugarcane,
Blueberries, and Soil: Lab Project Number: AMR 1720-90: 235W-1: 235-W.
Unpublished study prepared by PTRL West, Inc. 70 p.
Malek, D. (1993) Combined Chronic Toxicity/Oncogenicity Study with
DPX-D732-66 (Terbacil) Two Year Feeding Study in Rats: Lab Project
Number: 9027-001: 453-93: 18260. Unpublished study prepared by E. I. du
Pont de Nemours and Co. 1430 p.
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Support of the Terbacil Registration Standard. Transmittal of 1 Study 1
Heldreth, K.; McKelvey, R. (1996) Influence of Terbacil on Seed Germination,
Seedling Emergence, and Vegetative Vigor of Several Terrestrial Plants:
Supplement No. 1: Lab Project Number: AMR 2073-91: MR 10421.
Unpublished study prepared by DuPont Agricultural Products. 414 p.
Hughes, J.; Alexander, M. (1996) DPX-D732-66: Influence on Growth and
Reproduction of Navicula pelliculosa: Lab Project Number: AMR 3723-95:
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Unpublished study prepared by Wildlife International Ltd. and DuPont Haskell
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Applications of Sinbar Herbicide at Maximum Label Rates: Lab Project
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du Pont de Nemours and Co. and PTRL-West. 85 p.
131
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132
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
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 A 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. Within 90 days after you receive this Notice you
must respond as set forth hi Section in below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data hi the manner
specified by this Notice (see section ni-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 produces) 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. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 5).
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
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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 seven 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
Section II
Section HI
Section IV.
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Inquiries and'Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions (Form A)
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status
and Registrant's Response Forms with Instructions (Form B)
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 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 produces) containing the subject active ingredients.
SECTION n. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OR DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes 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 (Telephone number
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).
AU 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].
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(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 m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
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III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and 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 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.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver (s).
A discussion of how to respond if you choose 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 generic data requirements of this Notice is
contained in Section ffl-C. A discussion of options relating to requests for data waivers is
contained in Section ni-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page of both Data Call-In Response Forms and the Requirements Status and
Registrant's Response Forms (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 hi preparing your response, call or write the
contact person(s) identified in Attachment 1.
a. 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 completed Generic and Product Specific
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Fprm(s). If you
choose this option, these are the only forms that you are required to complete.
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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.
b. 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 (Attachment 3), 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
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
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 Branch, Registration Division, Office of Pesticide Programs EPA by
calling (703) 308-8358. '
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. 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 if
the active ingredient in the product is derived exclusively, from purchased, registered pesticide
products containing the active ingredient. 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: /
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is me ultimate source of the active ingredient hi your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain hi compliance; and
(iii). 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
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you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific
data requirements.
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 requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they ,
and you are not 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.
d. Satisfying the Generic Data Requirements of this Notice
There are various, options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section in-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your, response must be on the
forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed hi Section in-D. 1. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for 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.
2. Product Specific Data Requirements
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 choose 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 hi Section ni-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
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for product specific data (contained in Attachments 2 and 3, respectively). 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 also must be submitted for
each product listed on the Data Call-in Response Form unless the voluntary cancellation option
is selected. 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.
a. , Voluntary Cancellation .
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your produces) containing the active ingredient that is the subject of mis 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 both the '
Generic and Product Specific Data Call-in Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms 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.
b- Satisfying the Product Specific Data Requirements of this Notice.
1 '
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a.and.7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specificdata
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document. ,
c.
Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-in
Response Form and the Requirements Status and Registrant's Response Form as well as any
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other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic 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 you to additional instructions
provided hi this Section. The options are:
(1) I will generate and submit data within the specified timeframe (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 upgradeable (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 hi 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 require
Agency approval of test protocols in advance of study .initiation. Those studies for which a
protocol must be submitted have been identified hi 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 hi 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 hi Section II-C. If the Agency rejects your protocol you will be
notified hi 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.
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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. 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
^formation 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 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. 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
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 registrant1 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.
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I
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 the 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, offer to share in the burden of producing the data upon terms to be agreed to
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 burden 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 normally will 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 hi 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.
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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 GFR
Part 160. As stated in 40 CFR 160.3 '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, means "any material derived from a test system for examination or
analysis."
Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must 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.
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 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 usually are 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.
c.
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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 hi 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 upgradeable, 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
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. 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 also should 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-rninimum." For ecological effects studies, the
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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. ~—~ :—
2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option 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)
(2)
(3)
(4)
(5)
(6)
I will generate and submit data within the specified time-frame (Developing
Data)
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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 - The requirements for developing product specific data are the
same as those described for.generic data (see Section ffl.C.l, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data ~ If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
m.C.l, Option 2). However, 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.
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Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section ni.C.l., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section ni.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
m.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section IILC.1., Option 6) apply to this option for product specific data.
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, and in the generic data requirements
section (ni.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
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 requirements) are not appropriate for your product.
a.
Low Volume/Minor Use Waiver
Option 8 under item 9 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 low volume pesticides to be only those active ingredients 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 is used for both high volume and low
volume uses, a low volume exemption will not be approved. If all uses of an active ingredient
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 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.
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.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:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, 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.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of produces) containing the active ingredient
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.
(iv) Total indirect production cost (elg. plant overhead, amortized plant and
equipment) charged to produces) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) 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.
(vi) 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.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, 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 in terms of its
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benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient 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.
b. Request for Waiver of Data
Option 9, under Item 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 requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
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 hi writing. If the Agency
determines that the data requirements of this Notice are not appropriate 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 product(s), 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.
2. Product Specific Data
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 product specific 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
148
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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.
SECTION IV.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE ~~ ~
IV-A NOTICE OF INTENT TO SUSPEND
• - . : - x
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.
5.
6.
7.
8.
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: ,
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).
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section IH-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
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:
149
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i. 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.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated hi 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 hi the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox 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.
rV-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.
150
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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 generally would
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 produces)
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 also must 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 canceDation of your produces) 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 distributers, 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 a 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.
151
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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.
All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and 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 Generic and
Product Specific Data Call-in Response Forms need be submitted.
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
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-in Response Forms with
Instructions
Generic Data Call-In and Product Specific Data Call-in Requirements Status
and Registrant's Response Forms with Instructions
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
3-
4-
5-
6-
Requirements for Reregistration
List of Registrants Receiving This Notice
Confidential Statement of Formula, Cost Share and Data Compensation Forms
152'
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TERBACIL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing TERBACIL.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistratibn of
TERBACIL. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant'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), (6) a list of registrants receiving this DCI (Attachment 6) and
(7) the Cost Share and Data Compensation Forms in replying to this TERBACIL Product Specific
Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA JREQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for TERBACIL are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on TERBACIL are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible TERBACIL products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Karen Jones at (703) 308-8047.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Karen Jones
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: TERBACIL
153
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TERBACIL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Terbacil.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of Terbacil. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic
Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant'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 TERBACIL Generic Data Call In (Attachment F). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Terbacil are
contained in the Requirements Status and Registrant's Response, Attachment C. The Agency has
concluded that additional product chemistry data on Terbacil are needed. These data are needed
to fully complete the reregistration of all eligible Terbacil products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Emily Mitchell at (703) 308-8583.
All responsades to this Notice for the generic data requirements should be submitted to:
Emily Mitchell, Chemical Review Manager
Reregistration Branch I
Special Review and Registration Division (H7508W)
Office of Pesticiafde Programs
U.S. .Environmental Protection Agency
Washington, D.C. 20460
RE: TERBACIL
154
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
and are to be used by registrants to respond to generic and product specific Data Call-Ins as
.part of EPA's Reregislration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI
letter as part of a RED document you have been sent just the product specific "Data Call-In
Response Forms." Only registrants responsible for generic data have been sent the generic
data response form. The type of Data Call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 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.
The 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 rnaintaining 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 suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S. W., Washington, D.C. 20460; arid to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
157
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Iteml. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. ON BOTH FORMS: This item identifies the type of Data Call-In. The date
of issuance is date stamped.
Item 4. ON BOTH FORMS: 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. ON BOTH FORMS: Check 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. Since this Data Call-In requires both generic and product specific data,
you must complete item 5 on both Data Call-In response forms. You do not
need to complete any item on the Requirements Status and Registrant's
Response Forms.
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed in Item 2 and used hi the subject product. By
electing this exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained hi 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 hi your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are hi 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
158
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are registered), you may not claim a Generic Data Exemption and you may not
select this item.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in " '• "—
Item 6b.
Item 7a.
Item 7b.
ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated hi 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.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes." .
For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
your product is identical to another product and you qualify for a data
exemption.. You must provide the EPA registration numbers of your spurce(s);
do 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.
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.
NOTE: Item 7a and 7b are not applicable for Generic Data.
159
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8. ON BOTH FORMS: 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 initialled and
dated in the space provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact. '
160
-------
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166
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Instructions For Completing The "Requirements Status and Registrant's Response
, Forms" For The Generic and Product Specific Data Call-In
Note:
You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
may wish to report that your product has already been transferred to another company or that yon have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure mat its records are correct.
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product registrant only
• and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Requirements Status and Registrant's Response Forms."1 Only registrants
responsible for generic data have been sent the generic data response forms. The type of
Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type
of DCF) on each form.
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. Please read these instructions carefully before fillingout the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient. ,. /
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The 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 suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, 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.
167
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM:, This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-in. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-in. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to this Data
Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-In 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. ON BOTH FORMS: 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 HI of the Data Call-in Notice, 90-day progress reports are required for
all studies.
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.
168
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
-Item 6.
Item 7.
ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. 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
ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product^ Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
169
-------
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active •
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-in notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the date stamped on the letter
transmitting the Reregistration Eligibility Decision document, and not from the
date of receipt. However, your response to the Data Call-In itself is due 90
days from the date of receipt.
Item 9. ON BOTH FORMS: 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.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and
submit it within the time frames specified hi 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 hi the Data Call-In Notice and that I will provide the protocols
and progress reports required hi item 5 above.
Option 2. ON BOTH FORMS: (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.
170
-------
However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency 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 be subject to suspension.
Options. ON BOTH FORMS: (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 also submitting a completed "Certification of'offer to Cost
Share in the Development of Data',' form. 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 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 apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-In Notice
that my product is similar enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date 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.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By
indicating that I have 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.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study
thathas been previously classified by EPA as acceptable, core, core
171
-------
minimum, or a study that has not yet been reviewed by the Agency. If
reviewed, I am providing the Agency's classification of the study.
However, for Product Specific Data, 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 the
Agency 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). If I cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements"
form.
FOR THE GENERIC DATA FORM ONLY; The following three options
(Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status
and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 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.
Option 9. (Request for .Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate for my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
172
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Item 10.
Item 11.
Item 12.
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" form specifying 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.
ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her tide, and must initial
and date all other pages of this form. >
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response. '
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
^
may vrah to report tfaatyour product has already been trarnfcncd to another company orthatyou tove already v
173
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EPA'S BATCHING OF PRODUCTS CONTAINING TERBACEL AS THE ACTIVE
INGREDIENT 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 reregistration of products containing the active ingredient Terbacil
(5-Chloro-3-tert-bu1yl-6-methyl-uracil), the Agency has batched products which can be
considered similar in terms of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
product form (liquid, paste, solid, etc.), and labeling (e.g., signal word, precautionary labeling,
etc.).
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute lexicological studies to represent all the products within that batch.
The registrant has several options to participate with all or some other registrants, or to deal
only their own products within a batch, or to generate all the required acute lexicological studies
for each of their own products. If a registrant cho'oses 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. TRB must
approve any new formulations (that were presented to the Agency after the publication of the
RED) before data derived from them can be used to cover other products in a batch. Regardless
of whemer 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
174
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Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1,4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other.registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Table 1 displays the batches for the active ingredient Terbacil. All active products containing
Terbacil were placed into Batch #1.
Table 1.
: - ;-,
1
. 'It^s&sfckia, f
Steber,
352-317
ID80000900
KY81001000
OK92000900
OR80002100
OR92000300
OR92001600
PA90000300
VA90000400
WA80001000
WA920024QO
WA93000700
:;, - BsF^ctA^HwiagreasK'
Terbacil go%
Terbacil go%
Terbacil ' 80%
Terbacil go%
Terbacil go%
Terbacil gO%
Terbacil 80%
Terbacil gO%
Terbacil go%
Terbacil go%
Terbacil gQ%
TerbacO gO%
"• "," ' *
':,""' Form, '"*
powder
powder
powder '
powder
powder
powder
powder
powder
powder
powder
powder
powder
175
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a.
b.
' c.
d.
e.
f.
g-
h.
i.
j.
All the blocks on the form must be filled in and answered completely.
If any block is not applicable, mark it N/A. -• .
The CSF must be signed, dated arid the telephone number of the responsible
party must be provided.
All applicable information which is on the product specific data submission
must also be reported on the CSF. v
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
all common names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mk English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
177
-------
178
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179
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180
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
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 suggestions for reducing this burden to. Chief Information Policy
Branch, PM-233, U.S. Environmental Protection Agency, 401 M St.. S.W.. Washington. DC 20460; and to the Office of
Management and Budget. Paperwork Reduction Project (2070-0106). Washington. DC 20503.
Please fill in blanks below:
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under Jhe authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
i '
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
an offer to be bound by arbitration decision under section 3(c)(2)(B){iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
Qdt6(SJ! ' . ' •
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law
Signature of Company's Authorized Representative
Name and Title (Please Type or Print)
Date
arm 8580 which is obselete
181
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-99
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 suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that: .
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1 )(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FiFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
182
-------
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The following is a list of available documents for TERBACIL that my further assist you
in responding to this Reregistration Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special Review
and Reregistration Information System at 703-308-7224. They also are available
on the Internet using WWW (World Wide Web) on WWW.EPA.GOV., or contact
Karen Jones at (703)-308-8047.
1.
PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for TERBACIL.
The following documents are part of the Administrative Record for TERBACIL 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
Chemical Status Sheet.
1. 'Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
184
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