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NA: Not applicable since the previous MOE exceeded
None: No Engineering Controls exist for this scenario.
* Absorbed Dermal Dose (mg/kg/day) = (daily absorb
b Dermal Absorbed MOE = NOEL (2 mg/kg/day) / d<
Additional PPE:
la Double layer of clothing with chemical resistant glo
Ib Double layer of clothing with chemical resistant glo
2a Double layer of clothing with chemical resistant glo
6 Singel layer of clothing with chemical resistant glov<
7 Double layer of clothing with chemical resistant glo\
8 Double layer of clothing with out chemical resistant
-------
i. Intermediate-term
" The risks calculated from intermediate-term exposures to thiobencarb indicate that
risks from exposures to granular formulations (loading and applying) are lower than those
from exposures to the liquid formulation/spray applications. For the granular
formulations, the MOEs exceed 100 for all scenarios (except loading to support aerial
application) with the addition of personal protective equipment. For many of the liquid
formulation/spray application scenarios, the MOEs do not reach 100, even with
engineering controls.
Granular Formulations: The Agency believes the risks resulting from
intermediate-term exposures to the granular formulation are overestimated due to the use
of the 60.2 percent dermal absorption value for the granular scenarios. In general, dermal
absorption of granular formulations has been found to be significantly lower than for
liquid formulations. Therefore, the Agency has determined that risks to handlers of
granular formulations will be adequately mitigated with the addition of personal protective
equipment.
liquid Formulations: The Agency believes that risks resulting from intermediate-
term exposures to persons handling liquid formulations are overestimated due to
limitations with the hazard i^gg^Q^ an(j tne dose-response assessment for the
intermediate-term endpoint, particularly in light of the absence of serious effects to these
target organs in either the subchronic neurotoxicity or rat chronic feeding study, which
suggest the lack of a deleterious response to thiobencarb by the kidney and/or liver. The
Agency Believes that "risks" to 1^31^ usingliquid formulations will be adequately
mitigated with the used of engineering controls and personal protective equipment.
ii. Post-Application Workers
Since no dislpdgeable foliar residue studies or concurrent dermal samples were
submitteS to me gpA for this MD to measure post-application reentry, a rough surrogate
post-application assessment was performed as a default. Only the short-term endpoint (25
mg/kg/day) was used for the risk assessment, since EPA does not anticipate that
!mermeaiate:term exposures (i.e., 7 days or more of exposure) are likely to occur for
post-application workers for these crops in early-stage development. EPA assumed in the
surrogate ''assessment' "that "dermalabsorption would be significantly lower that the 60.2
percent used in me handler assessment, since dermal exposure would be to dry residues.
The surrogate post-application risk assessment indicated that at all application rates (i.e.,
4-8 pounds active ingredient per acre), risks would be acceptable to post-application
workers entering treated areas to perform tasks, such as scouting, thinning, or hoeing,
provided entry is postponed for 24 hours following application.
32
-------
was based. on the parental/systemic .toxicity characterized as enlargement of the
centrilobular heptocytes in both generations, hepatocyte single cell, necrosis observed in
both sexes of both generations, and renal atrophic tubule consisting of regenerated
epithelium. This NOEL is supported by the identical NOEL/LOEL established in the 90-
day neurotoxicity study in rats; the NOEL was 2 mg/kg/day and the LOEL was 20
mg/kg/day based on systemic toxicity manifested as statistically significant increases in
relative liver weights of male and kidney weights of female rats.
For dermal absorption, the TESC determined the thiobencarb dermal absorption
factor was 60.2% at 10 hours based on a rat dermal absorption study. This represents an
upper bound estimate of absorption since the skin was washed approximately 1 hour prior
to dosing rather than the recommended 24 hours. However, if the study was repeated
with the skin washed 24 hours before treatment, the Agency anticipates a lower dermal.
absorption factor for both thiobencarb formulations (i.e. emulsifiable concentration and
granular).
Alternations in liver and kidney weights seen in the subchronic neurotoxicity study
were corroborated with histopathological lesions in these organs in the multi-generation
reproduction study indicating the liver and kidney to be target organs following
intermediate exposure (i.e. up to several months) to thiobencarb-inducted toxicity at 20
mg/kg/day. However, the histopathological effects observed to the liver and kidney are
not considered severe. Instead, these effects can be considered a detoxification effect to
thiobencarb following an intermediate-term exposure. The lack of renal or liver lesions
in the rat chronic feeding study provides support that the target organs'have a
detoxification reaction to thiobencarb. . . .
b. Occupational Exposure
In terms of occupational exposure, the unit exposure for mixing/loading liquids for
aerial application with a closed system (MOE = 18) is derived from four registrant
submitted studies in PHED. There are 31 replicates for hand, 16 to 22 replicates for other
dermal exposure, and 27 replicates for inhalation. From the 31 replicates in the PHED,
only 138 samples (approximately 4%) had non-detectable residues. Dermal and inhalation
exposure data are rated as high confidence based on the number of replicates and analytical
grading criteria. The Agency's confidence in the unit exposure values are high because
exposures are based on detectable residues from high confidence studies. Since detectable
residues were observed, normalizing residue estimates to half the level of quantification
or half the level of detection to account for non-detectable residues is not necessary. This
provides additional support for the Agency's exposure estimates. In addition, most of the
dermal data are from studies involving whole body dosimeters, which are generally a more
accurate monitoring method than patch dosimetry. The assumption of 350 and 80 acres
treated for aerial and groundboom applications, respectively, are acceptable based on
agricultural practices.
. 34
-------
Even though MOEs are less than 100 for several intermediate-term handler
exposure scenarios, the Agency believes that these risks are over-estimated due to
limitations with the hazard identification and dose-response assessment. The resulting
histopathological lesions to the kidney and liver in the multi-generation study, and the
absence of serious effects to these target organs in either the subchronic neurotoxicity or
rat chronic feeding study, suggest the lack of a deleterious response of thiobencarb to the
kidney and/or liver. This effect, in addition to the overestimate of dermal absorption,
indicatej | a, COnse rvative, i estimate ,r of .intermediate-term handjer i risk. Therefore, the
Agency concludes the intermediate-term handler MOEs are under-estimated and.are not
at a risk of concern.
II II :
C. Environmental Assessment
HI ' mi ' i ,'.,,. : ':;
T,he environmental assessment consists of four sections: Ecological Toxicity Data;
Environmental Fate and Transport; Ecological Exposure and Risk Assessment; and
Environmental Risk Characterization, the first section reports ecological toxicity data
from laboratory studies. The second section describes the environmental fate and
transport data from field and laboratory studies, assesses the impact to water resources,
and details the environmental fate assessment. The third section estimates ecological
exposure and assesses me effects to non-target terrestrial and aquatic organisms. The
fourth section, the Environmental Risk Characterization Section, integrates the exposure
and effects assessment to determine the extent and potential for risk to the environment.
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
An oral (LDSO) study (preferably mallard or bobwhite quail) and two subacute
dietary (LC50) studies (one species of waterfowl, preferably the mallard duck and one
species of upland game bird, preferably bobwhite quail) are required to establish the
toxicity of a pesticide to birds. Results of these tests are tabulated below.
Table 10. Avian Acute Oral Toxicity Findings (LDSO).
Species
Northern bobwhite
Northern bqbwhife
Mallard duck
% A.I.
96.9
Technical IMC 3950
r , Technical IMC 1 3950
LD5fl
(mg a.i,/kg)
>4938a
~
MRIDNo.
Author/Year
MRID 42600201
S.M. Campbell and
M.Jaber. 1992.
Ace. No. 095106
Ace. No. 095106
Toxicity
Category
Practically
nontoxic
-
-
fulfills Guideline
Requirement?
Yes
No, invalid1"
No, invalid11
'There were no mortalities in birds receiving a dose of 1938 mg ai/kg thiobencarb.
* This study wasperformed by; IndustrialBio-Test Laboratories, Inc. Data.from all studies performed by this
laboratory are considered invalid and cannot provide any information for ecological risk assessments.
35
-------
Table 11. Avian Subacute Dietary Toxicity Findings (LC50)
Specie?,
Northern bob-white
Northern bobwhite
Mallard duck
% AJ. :
"Technical"
"Technical"
"Technical"
lAo
(ppmai)
>,5620a
--
,
MRIDNo.
Auflior/Year
Ace, No. 241483. 1979.
MRID 00057224 Ace; No. 095086
MRID 00057225 Ace. No. 095106
Toxicity
Category
Practically
nontoxic
Fulfills Guideline
Requirement?
No, supplemental
No, invalidb .
No, invalid1"
1 In this range-finding test for reproductive effects, there were no treatment-related mortalities in eight birds that were
fed a diet containing 5620 ppm for eight weeks.
b This study was performed by Industrial Bio-Test Laboratories, Inc. Data from all studies performed by this
laboratory are considered invalid and cannot provide any information for ecological risk assessments.
These results indicate that thiobencarb is practically nontoxic to avian species on
an acute oral basis. A supplemental study (Ace. No. 241483), which was designed to be
a range-finding study for determining dose levels for a reproductive study, suggests that
thiobencarb is probably also practically nontoxic to the bobwhite on a subacute dietary
basis. This conclusion is uncertain, though, since the study was not designed to test
subacute dietary toxicity and because only eight birds were used in the control and each
test level rather than the recommended ten. The guideline requirements for the acute oral
testing [GLN 71-l(a)] are fulfilled. The guideline requirements for subacute dietary
testing [GLN 71-2(a and b)] are not fulfilled. The Agency requires that additional data
be submitted on the subacute dietary toxicity to a waterfowl species, preferable the mallard
duck [GLN 71-2(b)]. The Agency is not requesting additional testing with an upland game
species [GLN 71-2(a)], (MRID 42600601)
(2) Birds, Chronic
Avian reproduction studies using the technical grade of the active ingredient
(TGTA) are required when birds may be exposed to a pesticide repeatedly or continuously
through its persistence, bioaccumulation, or from multiple applications, or if mammalian
reproduction tests indicate possible adverse reproductive effects. The preferred test
species are the mallard duck and bobwhite quail. Avian reproduction studies are required
for thiobencarb because it is persistent in the terrestrial environment and may
bioaccumulate. Results of these tests are tabulated below.
36
-------
study was 20 ppm (1 mg/kg/d). In a reproductive study, parental rats receiving a dietary
concentration of ,40 ppm (2 mg/kg/d) had histopathological effects on the liver (MRIDs
40446201, 40985701). As this was the lowest concentration tested, the NOEL was < 40
ppm. Changes in body weights and mcreased 'kidney' weights were observed at 2000 ppm
(100 mg/kg/d). No reproductive effects were observed at any test concentration, yielding
a NOEL of > 2000 ppm. Based on these results, 20 ppm is considered to be a
. :conserya^e'l'NpEL for" effects'' oJtMoben'carb on" wild "mammals.' (MRIDs 42130701,
'' 00154566, "40446261, "46985761)
(4) Insects
A honey bee acute contact LDSO study using the technical grade of the active
ingredient is required when the proposed use will result in honey bee exposure. A honey
bee acute contact study is not required for this pesticide because its use sites are not
expected to result in significant exposure to bees.
b. Toxicity to Aquatic Animals
"*"'" ' '''" '- ":; ''" " '' (1) Freshwater Fish, Acute
Tfwb freshwater fish toxicity studies using the technical grade of the active
ingredient are required to establish the toxicity of'a pesticide to freshwater fish. One study
should use a coldwater species (preferably the rainbow trout), and .the other should use a
watsiv^lie]: species (preferably the bluegill sunfish). Results of these tests are given
"below.
::Table" l|. JEVesEyajerllsh Acute Toxicity Findings.
Species
Bluegill sunfish
Rainbow trout
Rainbow trout
Bluegill sunfish
Channel catfish
Bluegill sunfish
Carp
Bluegill sunfish
Rainbow trout
Channel catfish
/SBAi.'"
10*
10*
95.5
95.5
95.5
Technical
Technical
84.0b
84.0b
84.0b
La*
(mg ai/L)
0.56
1.5
1.2
2.5
2.3
2.6
2.8
1.7
1.1
2.3
MRID No.
Author/Year
MRID 00050665, 1980
MRID 00050664, 1980
U.S.D.I., Ace. No. 095106, 1973.
U.S.D.I., Ace. No. 095106, 1973.
U.S.D.I., Ace. No. 095106, 1973.
Ace. No. 095106, 1974
Ace. No. 095106, 1974
U.S.D.I., Ace. No. 095106, 1973.
U.S.D.I., Access. No. 095106,
1973.
U.S.D.I., Access. No. 095106,
1973.
Toxjcity
Category
Highly toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Fulfills Guideline,
Requirement?
Yes, for TEP only
Yes, for TEP only
No, supplemental
No, supplemental
No, supplemental
No, supplemental
No, supplemental
No, supplemental
No, supplemental
No, supplemental
"Bolero 10 G
rBolero 8 EC
38
-------
The majority of the results indicate that thiobencarb is moderately toxic to fish on
an acute basis. The sole exception was an,acute test of bluegill sunfish exposed to Bolero
10 G (10% ai) that determined the LC50 to be 0.56 ppm ai. This result is inconsistent with
the results of two other acute tests which both determined that the LC50 for the bluegill
sunfish was greater, in the range of 2.5 to 2.6 ppm ai.p. Results of tests with rainbow trout
found that LC50's for this species are slightly greater than 1, putting it in the moderately
toxic range (> 1-10 ppm)'but close to the highly toxic range (0.1-1 ppm). The Agency
.therefore concludes that thiobencarb is moderately to highly toxic to freshwater fish.
The only fully acceptable studies on the acute toxicity of thiobencarb to fish were
conducted with Bolero 10 G. These studies fulfill only the guideline requirements for
testing with a TEP [GLN 72-1 (b) and 72-l(d)]. The guideline requirements for testing
with the technical grade [GLN 72-l(a) and 72-l(c)] are not fulfilled by any particular
studies, but the group of ten acute freshwater fish studies, when considered in its entirety,
is sufficient for fulfilling these guidelines. (MRID 00050664 and 00050665, Ace. No
095106).
(2) Freshwater Fish, Chronic
'A freshwater fish early life-stage test using the TGAI is required for thiobencarb
because the end-use product may be applied directly to water or expected to be transported
to water from the intended use site (rice) and because the following conditions are met:
(1) some aquatic acute LC50 and EC50 are less than 1 mg/1, (2) EECs in water (based on
measured concentrations) were greater than 1% of acute LC50 and EC50 values,, and (3)
the half-life in water is greater than 4 days. No study with a freshwater fish species-has
been submitted. A study with a marine/estuarine species (sheepshead minnow) was
submitted (MRID 00079112), but this study does not fulfill the guideline because it failed
to determine the NOEC. The guideline for an early life-stage toxicity study with a fish
species [GLN 72-4(a)3 has not been fulfilled. However, the Agency does not request that
the registrant submit a study for this guideline. Instead, the Agency requests that the
registrant submit a core study that tests the effects of technical.thiobencarb over the life-
cycle of a fish
-------
Table 14. Freshwater Invertebrate Acute Toxicity Findings.
1
Species
I * 1 1 '
Daphnid
Daphnia magna
Daphnid
Daphnia magna
Daphnid
Daphnia magna
Scud Gammarus
,4 ' i -,V- , * If ซ '"'''
pseudolimlmaeus
Scud Gammarus^
pseudolimimaeus
Crayfish
Procambarus clariai
Apple snail
Pomacea aludosa
% AX
94.4
82.25*
10b
95.5
85*
95.5
85*
JLCJ& or ECjo
(pprn ai)
EC50= 0.10
EC50=0.17
EC50 = 0.46C
LC50 = 1.2
LCSO = 0.72
LC50= 1.0
LC50 = 2.0
LCSO = 1.85
MRIDNo.
Author/Year
MRID 00025788
Ace. No. 25788, 1978.
MRID 00079118
1980.
MRID 00050666
1980.
U.S.D.I., Ace. 095106,
1973.
U.S.D.I., Ace. 095106,
1973.
Ace. No. 095106
MRID 40031001
Toxicity
Category
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Moderately
toxic
Moderately
toxic
Moderately
toxic
Fulfills Guideline
Requirement?
Yes
Yes, forTEP
No, supplemental
No, supplemental
No, supplemental
No, supplemental
No, supplemental
ปBokro8EC
*BolerolOG
The effect used to determine the EC30 was clumping of organisms.
The results indicate that thiobencarb is highly toxic to aquatic invertebrates on an
acute basis. The guidelme requirements for testing the XQAI [72-2(a)] and the TEP [72-
2(b)] are fulfilled. (Ace. No. 25788 and MRID 00079118).
(4) Freshwater Invertebrate, Chronic
An aquatic invertebrate life-cycle test using Daphnia magna using the TGAI is
required for thiobencarb because the end-use product may be applied directly to water or
expected to be transported to water from the primary use site (rice) and because the
following conditions are met: (1) some aquatic acute LC50's and ECso's are less than 1
mg/1, (2) EECs in water (based on measured concentrations) were greater than 1 % of
acute LCjo and EC50 values, and (3) the half-life in water is greater than 4 days. Daphnia
magna is the preferred test species.
"fable 15. Freshwater Invertebrate Chronic Toxicity Findings.
Species
Daphnid
Daphnia magna
Daphnid
Daphnia magna
I ii IF| i '11 1"\ '
% A.L
I. ' i
95.2 - 95.9
96.9
NOE
1.7
66
MRIDNo.
Author/Year
Ace. No.
241483
42680401
Putt, 1993
Endpoints Affected
Reduced number of
young, adult mortality
Reduced number of
young
Fulfills Guideline
Requirement?
Yes '
No,
Supplemental1
1 This study is supplemental because measure concentrations were highly variable, the solvent was changed during the
PCS!, toฎ solvent in the solvent control was changed at a different time than in the test solutions, and chemical analysis
of the test material was not performed immediately after the solvents were changed.
40
-------
The core life-cycle toxicity study measuring the toxicity of thiobencarb to the
daphnid (Ace. No. 241483) indicates that thiobencarb concentrations as low as 3.0 Mg/L
can inhibit the reproduction in freshwater invertebrates. The MATC of derived from this
study was 1.7 //g/L. -This toxicity value was used for conducting the risk assessment
because it is the only core (i.e., fully acceptable) data available and it yielded the lowest
toxicity estimate. A second life-cycle study with daphnid (M,RIP 42680401), which was
classified supplemental due to procedural deficiencies, yielded a greater toxicity estimate
(MATC=66 jug/L).
(5) Estuarine and Marine Animals, Acute
Acute toxicity testing ,with estuarine and marine organisms (fish, shrimp, and
oysters) using the technical grade of the active ingredient is required when an end-use
product is intended for direct application to the marine/estuarine environment or is
expected to reach this environment in significant concentrations. The preferred test
organisms are the sheepshead minnow, mysid shrimp and eastern oyster.
Estuarine/marine acute toxicity testing is required for this pesticide because its use on rice
is expected to result in significant exposure to marine and estuarine environments.
Application of thiobencarb on rice fields will contaminate tailwater (i.e., water discharged
from the water management system) which may flow, into estuaries. The tables below
show the results of these tests for fish and aquatic invertebrates. '
41
-------
Table 16. Acute Toxicity Findings for Marine/Estuarine Fish.
Species
1 : , :'?!,
Sheepshead minnow
Shecpshead minnow
Sheepshead minnow
Sheepsh' cad" minnow
Califqjtiift grunion
Leuresthes tenuis
(Static tests)
California grunion
Leuresthes tenuis
(Flow-through tests)
mi
Atlantic silverside
Menidia mcnidia
(Static tests)
Atlantic silverside
Menidia menidia
(Row-through tests)
Tidewater silverside
Media peninsulae
(Static tests)
Tidewater silverside
Media peninsulae
(How-through)
)ป:3S> ..; -
A''T::
95.1
95.1
85.51
90
90
90
' 90 ^
i . h . " i
" 90"",'
90
90
LC5o (ppm)
0.66
0.9
1.4
'"">" 0.9 "ll"'
0.31 (0 d old)
0.48 (7 d old)
0.59 (14 d old)
0.50 (28 d old)
0.27 (0 d old)
0.24 (7 d old)
0.38 (14 d old)
0.33 (28 d old)
0.46 (0 d old)
0.45 (7 d old)
0.63 (14 d old)
0.75 (28 d old)
0.39 (0 d old)
0.20 (7 d old)
0.41 (14 d old)
0.68 (28 d old)
633 (o'd'old)1"
0.40 (7 d old)
0.51 (14 d old)
1. 2 (28 d old)
0.30 (Od old)
0.46 (7 d old)
0.39 (14 d old)
0.82 (28 d old)
MRID No. Author/Year
MRID 00079112, 1979.
MRID 00079110, 1979.
MRID 00079111, 1979.
Borthwick and Walsh,
1981.
Borthwick etal., 1985.
ioxicny
Category
Highly toxic
Highly toxic
Moderately toxic
Not more than
"highly toxic"
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Moderately to
highly toxic
Highly toxic
rumus umaeune
Requirement?
Yes
Yes
Yes, for TEP only
Open literature,
supplemental
Open literature,
supplemental
"Bolero 8 EC
The results indicate that thiobencarb is highly toxic to marine/estuarine fish on an
acute basis. The guideline requirements for fish are fulfilled for the TGAI [GLN 72-3 (a)]
and for |TBP, Bolero 8 EC [GLN 72-3(d), MRID ]. (MRID 00079110, 00079111,and
' ' '" ''" "''
42
i ;,., Psiti:'jit a> :. ti ,, iigi:.;:,, : > ij; ::, .1, Jth t .1 .iillllL i liii; I l! 'il:., :h.,i:-!H; .l;i!,:ii: t :. , li ..it!!!; ii ::iiilia^^^^^^^^^^^^^^^^^^^^ liailii l!liซ^^^^^^^^^^^^ iilllii li^^^ 'A si :,;..;j jii.:.:;
-------
Table 17. Acute Toxicity Findings for Marine/Estuarine Invertebrates.
Species
Eastern oyster
(embryo-larvae)
Eastern oyster
(embryo-larvae)
Eastern oyster
(embryo-larvae)
Mysid shrimp
(<1 day old)
Mysid shrimp
(6-8 days old)
Mysid shrimp
(<1 day old)
Grass shrimp
Palaemonetes
pugio
Pink Shrimp
Penaeus duorarum
White Shrimp
Penaeus setiferus
Brown shrimp
Penaeus azetecus
Ghost shrimp
Fiddler crab
Shore crab
%AJ.
95.1
85.5a
90
94.6
95.1
90
85.5"
85.5"
"Tech.
ti
EC5D(ppra)
0.56
0.32
0.9 - 9.0
0.15
0.29
, 0.33
1.0 (adults),
0.38-0.57
(juveniles) .
0.57
0.31
0.47 \-
1.1
4.4
3.6
MRID No.
Author/Year
MRID 00079114, 1979.
MRID 00079115, 1979.
EPA-600/4-81-076,
Office of Research and
Development, 1981 .
MRID 00050667, 1980
MRID 00079117, 1979,
Borthwick and Walsh,
1981.
. Ace. No. 095106, 1975
MRID 00079113
Ace. No. 095106
Toxicity
Category
Highly toxic
Highly toxic
/
Moderately to
highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Moderately
toxic
Moderately
toxic
Moderately
toxic
Fulfills Guideline
Requirement?
Yes
Yes, for TEP
Open literature,
supplemental
,Yes
No, supplemental
Open literature,
supplemental
No, supplemental
No, supplemental
No, supplemental
The results indicate that thiobencarb is highly toxic to marine/estuarine mollusks
on an acute basis. The guideline requirements for mollusks are fulfilled for the TGAI
[GLN 72-3(b)] and for a TEP, Bolero 8 EC [GLN 72-3(e)]. The results indicate that
thiobencarb is also highly toxic for marine/estuarine shrimp. The guideline requirements
for shrimp are fulfilled for the TGAI [GLN 72-3(c)]. (MRID 00079114, 00079115 and
00050667). ,
(6) Estuarine and Marine Animals, Chronic
Data from estuarine/marine fish early life-stage and aquatic invertebrate life-cycle
toxicity tests are required if the product is applied directly to'the estuarine/marine
43
-------
environment or expected to be transported to this environment from the intended use site,
and when any one of the following conditions exist: (1) the pesticide is intended for use
such that its presence in water is likely to be continuous or recurrent regardless of toxicity;
(2) any acute LC5Q or ECjp is less than 1 mg/L; (3) the EEC in water is equal to or greater
than 1% of any acute EC50 or LQo value; or (4) the actual or estimated environmental
concentration in water resulting from use is less than 0.01 of any acute ECSO or LC50 value
and any of the following conditions exist: studies of other organisms indicate the
reproductive physiology of fish and/or invertebrates may be affected, physicochemical
properties indicate cumulative effects, or the pesticide has a half-life in water greater than
4 days. The preferred test organisms are the sheepshead minnow and mysid shrimp.
Chronic testing with thiobencarb is required because it has a primary use (rice) for
which It is applied directly to water or is applied to land which is subsequently flooded
With water. In addition, concentrations of thiobencarb measured in aquatic field studies
are as great as 0.085 ppin, which is greater man"O'.'bl of the LC50 for marine/estuarine fish'
and aquatic invertebrates. Results of this test are given below.
Table 18. Estuarine/Marine Chronic Toxicity Findings
Species
1 i I '
Mysid
Grass
shrimp
Opossum
Shrimp
Mysid
J ' '"'1, ; ' V ,'! 1., '''.H '' '
Sheepshead
Minnow
% A.I.
95.1
84.7
"Technical"
Not reported
95.1
NOEC
(ppb)
ND,
EC05=
9,8b
<21C
3.2
22
ND
LOEC
)
ND
21C
6.2
, '.PI ii ||M h, .1 ,
35
150
MATC,
(ppb)
ND
<21C
4.5
28
<15Q
MRID No,
Author/Year
MRID 00079117
Ace. No.
241484, 1977.
MRID 43976801
Bailey, 1993
McKenney, 1985
1 f .' , " :' '
MRID
00079112, 1979.
Endpatnfc?
Affected
Reproduction,
survival of
offspring
Adult mortality
Survival of
offspring
Number of
young produced
Wet weight
Fulfills
Guideline-
Requirement?
No,
supplemental
No,
supplemental
No,
supplemental
Open literature,
supplemental
No,
supplemental
* ND designates that the value was not determined.
ฅ The NOEC could not determined because the control had no replication. A nonlinear regression analysis (Bruce and
Vcrstecg, 1992) was used to calculate the ECOS which can be used in lieu of the NOEC.
* Levels are highly uncertain because measured concentrations were highly variable.
The results indicate that a concentration of 150 ppb can adversely affect the growth
of juvenile fish. Concentrations less than 150 ppb may also have had adverse effects if
they had been tested. Because the study failed to determine NCDECs, the guideline
requirement for a fish early life-stage study [72-4(a)] has not been fulfilled. (MRID
00079112)
44
-------
The Agency does not request that the registrant repeat the fish early life-stage study
[GLN 72-4(a)]. Instead, the registrant is required to submit a core study that tests the
effects, of technical thiobencarb on the life-cycle of a fish (GLN 72-5). The Agency is
justified in requiring a fish life-cycle test because the end-use product is intended to be,
applied directly to water or is expected to transport to water from the intended use site
(rice), and because the EEC is greater than one-tenth of the NOEC in the invertebrate life-.
cycle test. This test should be conducted with a freshwater fish, preferable the fathead
minnow or rainbow trout. The Agency reserves the right to require a second fish life-
cycle study using a saltwater species at a later time.
Chronic toxicity of thiobencarb to crustaceans is uncertain because none of the
studies submitted to the Agency was conducted in accordance to the guidelines for this
study. Based on supplemental data, the MATCs for crustaceans range, from 4.5 to 35
ppb. Although no single study provided core data, the combination of supplemental data
from four separate studies is sufficient to characterize the toxicity of thiobencarb to
marine/estuarine crustaceans. The guideline requirement for life-cycle testing with a
shrimp or mysid [GLN72-4(b)] is thus fulfilled. (MRID 00079117 and 43976801, Ace.
No. 241484, McKenney, 1985)
(7) Aquatic Field Studies
The conclusion of high risk to aquatic organisms, based on results from laboratory
toxicity tests, triggered the requirement for aquatic field testing with thiobencarb (GLN
72-7). The following aquatic field studies have been conducted on the use of thiobencarb
on rice. * .
Table 19. Aquatic field studies on thidbencarb on rice.
Title ' , > " ^
Studies in Halls Bayou to Test the
Effects of a Pre-Emergent Herbicide,
Bolero, on Aquatic Organisms
Impact of Bolero Runoff on a '
Brackish Water Ecosystem
Thiobencarb: 'Studies on Residue
Level and Behavior in Selected
Irrigation Creeks in Agricultural Areas
in Saga Prefecture, Southwestern
Japan
Locafioa and
Date
Halls Bayou/
Chocolate Bay,
Brazonia County,
Texas 1979
Matagorda,
Texas
1982 - 1984
Saga Prefecture,
Kyushu, Japan
1975-
Reference
Ace. No.
241484
MRDDs
92182086,
92182089
Ace. No.
241476
Performed By
Harper
Environmental
Consulting
Company
Biospheric,
Inc.
Life Science
Research
Institute
Sponsor
Chevron
Chemical
Company
Chevron
Chemical
Company
Unknown
Fulfills Guideline
Requirements'?
No, supplemental
Yes1
No, supplemental
Following the review of this study, an additional aquatic field study was requested to monitor aquatic residues in-
other localities where rice is grown. This additional study, however, was waived in December 1993. No further field
studies are requested for thiobencarb at this time.
45
-------
iir Mile iii'ini11! liiri1!11 'j
I'SIIMl"! iriMll"! IB MrTU
ffTfni
iMilsJBayou_Study: The first field study conducted in the U.S, was in rice fields
bordering Halls Bayou, a tidally influenced, narrow stream that empties into West Bay
near Galvestpn,"Texas". TMs"sta3y"Is also referred to as me Chocolate Bay study. This
estuarine area is a complex and highly important ecosystem that supports many
commercial species. . Contaminated water was released into the bayou when rice fields
were irrigated with a.small amount of water (i.e. flushed) to moisten the soil. Also, heavy
rainfall occurring during the experiment resulted in two additional releases of
contaminated water. Sampling sites were established 500 ft downstream and 500 ft'
upstream of the point of discharge from the rice fields. Water samples collected at the
field outlets and in Halls Bayou were analyzed for residues of thiobencarb. Fish, nektonic
macroinvertebrates, benthic organisms, and phytoplanktpn were also sampled in these
areas before, during, and" after discharge'from'the nee fields. Fish and macroinvertebrates
were also held in cages in Halls Bayou to monitor their response to the discharge of
thiobencarb.
Due to poor experimental design and experimental conditions that caused excessive
stress to the caged organisms, the Agency concluded that the results of the caged tests with
fish and shrimp were invalid. They thus yield no information which can be used for risk
assessment. Other parts of the field study provided some information and were thus
classified as supplemental
The highest concentrations of thiobencarb were measured on a day when heavy
rainfall (3.23 inches) occurred on the same day that thiobencarb was applied, resulting in
an unscheduled flush overflow. Peak; thiobencarb .concentra.ti.ons were 8.9 ppm (8900 ppb)
where the tailwater exited the rice field and 690 ppb at the point, where the drainage water
entered Halls Bayou. The highest concentrations measured in the Halls Bayou on days
that were not associated with heavy rainfall were 83 ppb at the upstream station (E) and
64 ppb at the downstream station (F). The abundance of Ssh, invertebrates, and plankton
sampled at the downstream station were similar to or greater than those sampled at the
upstream station. Gillnet catches declined in only one of the two areas sampled after
discharges from the rice fields. Seine and trawl sampling indicated a decline in abundance
of fish and invertebrates occurred near the end of the study. All declines were observed
at both the upstream and downstream stations. Some differences in species composition
of fish and invertebrates were observed between the upstream and downstream stations,
and some changes in the species composition of benthic organisms were observed over
time. None of these differences, however, could be conclusively linked to the discharge
of thiobencarb.
The biological findings of the Halls Bayou study were inconclusive since there
Were no significant differences in species abundance or clear trends in the changes in
species composition between stations upstream and downstream of the point of discharge.
The upstream stations, being only 500 feet upstream of the site of discharge, were likely
close enough to be affected by contamination moving upstream as the result of tidal
mixing. Also, the abundance and composition of species were probably influenced by
46
-------
other factors, including tidal cycles, salinity changes, and release of other pesticides from
neighboring areas. Small samples sizes further limited the usefulness of this study. This
study does not provide much useful information on the effects of thiobencarb on the
estuarine environment.
Matagorda Study: A larger aquatic field study was conducted in 1982-1984 near
Matagorda,, Texas. The site consisted of a rice field that drained through a ditch into the
tidal waters of the lower Colorado River of eastern Texas. As with Hall's Bayou, this
estuarine area is a complex and highly important ecosystem that supports many
commercial species. No thiobencarb applications were made in 1982; this year provided
baseline data for the site. Baseline thiobencarb concentrations were as high as 9 ppb. In
1983 and 1984, approximately 500 acres of the field were treated with thiobencarb at a
rate of 4 Ibs ai per acre. Fields were flushed with water within 3 to 12 days after
application. Data collected from 1982 through 1984 included (1) residues of thiobencarb
in water, sediment, fish and shrimp; (2) catch per unit effort measurements of fish and
aquatic invertebrates; and (3) percentages of grass shrimp (Palaemonetes pugid) that were
gravid. While samples were collected during all three years of the study, the sampling
effort on the third year was very poor.
A control station was also planned on the Colorado River upstream of the
confluence with the drainage ditch. However, during the course of the study, the Agency
and the registrants agreed that this station could not serve as a control for the field study
because it contained preexisting residues of thiobencarb. It was therefore only possible
to compare residues and biological samples collected during 1983 and 1984 to those
collected during 1982, before the initial treatment. This represents a shortcoming of this
study since the results could have been influenced by yearly fluctuations in environmental
conditions that are unrelated to the applications of thiobencarb. Another shortcoming is
that other pesticides (ordram, basagran, machette, and propanil) were applied to fields that
drain into the test ditch during the period of this study. The toxicity of these pesticides
could have contributed to the observed effects. ,
The results of the study were:
1. Residues of thiobencarb were transported into the estuary via runoff and drift.'
Residues in water exceeded the aquatic invertebrate MATC (1.7 ppb). Maximum
residues measured in water, sediment, fish, and shrimp were 25.1 ppb, 50 ppb,
2400 ppb, and 970 ppb, respectively.
2. Although the overall population of fish was apparently not affected, marked
declines were observed during the treatment years in three species, Gambusia
affinis, Dormitator maculatus, and Poecilia latipenna.
47 .
-------
3. Several taxa of aquatic invertebrates showed substantial decline in numbers caught
per unit effort. Species richness and diversity also declined significantly during
treatment years.
4. The percentage of gravid shrimp decreased significantly in 1983 compared to
1982. The decline was aboutu 50%. at stations1and,2, and averaged 23 % for all
four stations. (Sampling was inadequate to assess the effect on the percentage of
gravid shrimp in 1984.)
5. ^)^of^&^hm&^ai^Mi0reypprtiapatronus) was observed in the area where
the field runoff entered the drainage ditch. It occurred at the point of discharge
from the drainage canal, one to two days after a post-application flush of the rice
fields. Although other pesticides that were applied that year (ordram, basagran,
!|id propanil) may have been present in the tailwater, this kill was attributed to
thiobencaEb contamination because the dead fish contained high residues of
thiobencarb (mean of 3.56 ppm).
6. Field BCF for thiobencarb were estimated to be 109X for fish and 44X for shrimp.
Declines in fish, aquatic invertebrates, and gravid shrimp cannot conclusively be
attributed to the use of thiobencarb. Nevertheless, the findings in the field were consistent
with effects demonstrated in laboratory studies. They suggest that the application of
thiobencarb to rice fields may result in significant environmental damage to the adjacent
estuarine habitat. 'Possible effects^jnclude^chronic effectsrto..sensitive fish, acute and
chronic effects to ecologically ^important aquatic invertebrates, chronic effects to grass
shrimp and possibly to commercial shrimp, and indirect detrimental effects to organisms
at higher trophic levels that depend on these organisms for food.
Japan Study: The Agency reviewed a study that measured residues of thiobencarb in creek
water after application to rice paddies in Japan. Thiobencarb was applied in the form of
7% granules at a rate of 30 kg/ha, which is equivalent to 1.9 Ib ai/A. Water samples were
taken from ten stations along creeks that flow through the rice fields and drain into the
Hayatsue River. Water sampling was conducted from March through November, with
:thioBencarb tt^^iatsl.Bemg'madelfbm^ne'lS ^^g^ j^iy 2.' The creeks served as
storage for irrigation water until May, when the water is pumped onto the fields. The
creeics resembleS large ponds during the storage period.
Very low thiobencarb concentrations (0.2 ppb or less) were reported at all stations
in March and April before applications were made. Concentrations peaked at the sampling
period of My 1, when concentrations at most stations were between 20 and 40 ppb. The
greafest concentration was measured was 40.5 ppb. Concentrations declined fairly rapidly
thereafter- the half-life of thiobencarb in creek water was estimated to be 8.8 days. This
rate of decline represents dilution as well as biological and physical degradation processes.
The Agency cannot interpret the significance of these results or extrapolate conclusions
48
-------
to other areas because of the lack of important information on the test conditions, such as
flow rates within the creeks and rainfall during the study.
A difficulty with all three of the field studies was that water flow measurements
were not made^ making it impossible to discern effects of dissipation versus dilution.
While water residues were generally short-lived, it is not clear whether thiobencarb
residues were broken down by chemical or biological forces, or they were swept away and
diluted ,by tidal flow. Because it is possible that dilution was the primary mode of
dissipation in all three studies, the rate at which thiobencarb degrades by chemical or
biological means in estuaries remains unknown. Thiobencarb residues thus may persist
longer in other areas where dilution is of less importance in the dissipation of residues.
The three biological field studies demonstrate that application of thiobencarb on
rice can- cause significant contamination to'water, sediments, and aquatic organisms in off-
site aquatic habitats.. Harm to estuarine and freshwater ecosystems is possible when
thiobencarb is used in southeastern United States. Although shortcomings of these studies
make it impossible to identify thiobencarb as the sole cause of observed adverse effects,
the studies fail to refute the Agency's presumption that the use of thiobencarb on rice
results in severe effects on aquatic ecosystems.
c. Toxicity to Plants .
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is required for
herbicides which have terrestrial non-residential outdoor use patterns and which may move
off the application site through volatilization (vapor pressure _>_1.0 x 10"5mm Hg at 25ฐC)
or drift (aerial or irrigation), and/or which may have endangered or threatened plant
species associated with the application site. Terrestrial plant testing is required for
thiobencarb because it is an herbicide with a terrestrial nonresidential use pattern (rice) and
because aerial applications may result in drift.
For the seedling emergence and vegetative vigor testing the follqwing plant species
and groups should be tested: (1) six species of at least four dicotyledonous families, one
species of which is soybean (Glycine.max), and another of which is a root crop, and (2)
four species of at least two monocoryledonous families, one species of which is corn (Zea
mays).
v
Results of Tier n seedling emergence toxicity testing on technical thiobencarb are
given below. ' f ,
49
-------
^ IIIIIH Jl :iiil
"it S'fflT'v I*'!
Table 20. Nontarget Terrestrial Plant Seedling Emergence Toxicity Findings (Tier II).
Species
Monocot Com
Monocot Oat
Monocot Onion
Monocot Ryegrass
Dicot/Root CropCarrot
Djcpt-Cabbage
Dicot-Cucumber
Dicot-Lettuce
Dicot-Soybean
Dicot-Tomato
^ i'i jtป
%AL
96.6
Parameter
Affected
Shoot length
Shoot length
Shoot length
Mortality
Shoot length
Shoot length
Shoot length
Mortality
Shoot length
Shoot length
EC^
(Ib ai/A)
>1.7
0.086
2.0
0.01,9
>3.1
0.082
>1.7
0.27
>1.7
1.1
NOBC
(Ib ai/A)
1.7
0.055
0.94
0.00511
2.1
0.071
0.16
-
0.94
0.94
MRID No.
Author/Year
MRID 41690902
Hoberg, J.R.
1990
Fulfills Guideline
. + - - -i" * ! 5-H ^
Requirement?
Yes
Yes
Yes
Yes2
Yes
Yes
Yes
No, supplemental
Yes
Yes
1 This NOEL is based on 17% mortality of plants occurring at the next higher test level, 0.011 Ib ai/A.
2 Seedling emergence data for ryegrass is upgraded from supplemental to core.
In the tier n seedling emergence test, mortality of test plants occurred in the tests
with ryegrass, cabbage, and lettuce. Mortality was the most sensitive toxic endpoint for
these species (plants tended to die shortly after emerging). Grasses appear to be
exceptionallysensitiveto tMobencarb.The most sensitive species was ryegrass, a
monocot^ for which the EC^ based on mortality (i.e. LC25) was 0.019 Ib ai/A. The most
sensitive dicot was lettuce. The lettuce EC-^ based on mortality was estimated to be 0.27
Ib ai/A, but this is not a definitive result since it was calculated from supplemental data.
The guideline requirement for seedling emergence testing [123-1 (a)] is only
partially fulfilled. Core seedling emergence data is outstanding for lettuce. Lower
dosages may need to be tested to determine the NOEC for this species. (MRID 41690902)
Results of Tier II seedling vegetative vigor toxicity testing on the technical
thiobencarb are given below.
Table 21. Nontarget Terrestrial Plant Vegetative Vigor Toxicity Findings (Tier II)
Species
Monocot- Corn
iiniiii
Monocot Oat
Monocot Onion
Monocot Ryegrass
Dicot/ Root Crop-
Carrot
Dicot-Cabbage
Dicot Cucumber
DiemLettuce
Dicot-Soybean
DicotTomato
% AX
96.6
Parameter Affected
Shoot length, shoot
weight, and root weight
Shoot weight
Shoot length
Shoot length
Shoot length, shoot
weight, and root weight
Root weight
Shoot weight and root
weight
Root weight
Shoot weight
Root weight
ECซ
(Ib ai/A)
>2.2
0.17
1.2
0.073
>2.2
1.2
a
1.3 '
1.2
1.8
NOEC
Obai/A)
2.2
0.12
0.80
0.020
2.2
1.4
<0.12
0.80
0.80
2.2
MRID No.
.Author/Year
MRID 41690902
Hoberg, J.R.
1990
Fulfills Guideline
Requirement?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
*Greater than a 25% reduction was recorded at some or all exposure levels, but the EC^ could not be determined
because no dose-response relationship was apparent.
-------
In the Tier II vegetative vigor tests, soybean was the most sensitive dicot and
ryegrass was the most sensitive monocot. The guideline requirement for vegetative testing
[123-l(b>] is fulfilled. (MRID 41690902)
(2) Aquatic
Aquatic plant testing is required for any herbicide which has Outdoor non-
residential terrestrial uses in which it may move off-site by runoff (solubility > 10 ppm
in water), by drift (aerial or irrigation), or which is applied directly to aquatic use sites
(except residential). The following species should be tested: Kirchneria subcapitata,
Lemna gibba, Skeletonema costatum, Anabaenaflos-aquae, and a freshwater diatom.
Aquatic plant testing is required for thiobencarb because it may be applied directly to
water, it may be applied aerially, and it is applied to rice paddies where it is expected to
contaminate the tailwater that leaves the field.
Results of Tier II toxicity testing on technical thiobencarb are given below.
Table 22. Nontarget Aquatic Plant Toxicity Findings (Tier II).
Species
Freshwater diatom
Navicula pelliculosa
Duckweed Lemna gibba
Green algae
Selenastrum capricomutum
Marine diatom
Skeletonema costatum
Blue-green algae
Anabaena flos-aquae
Marine diatom
Skeletonema costatum
% A,L
96.6
95.5
EC,B
Cppb>
380
770
17
73
>3100
327-459a
NOBC
(ppb)
65
140
13
18
3100 .
_.
. MRID Nb.%
Author/Ye^r
*.
MRID 41690901 Giddings, J.M.
1990
EPA-600/4-81-076, Office of
Research and Development, 1981.
Fulfills Guideline
Requirement?
Yes
Yes
Yes
Yes
Yes
Open literature,
supplemental
-50
The Tier II results indicate that green algae is the most sensitive aquatic plant
species. A thiobencarb concentration of 17 ppb ai is predicted to cause a 50% reduction
in the growth and reproduction of this species. The guideline requirement (123-2) is.
fulfilled (MRID 41690901).
2. Environmental Fate
a. Environmental Fate Assessment
Thiobencarb is generally nonpersistent in the water column but moderately
persistent in soils and sediments. Thiobencarb dissipates in the environment by binding
51
-------
to soil, by aerobic soil metabolism at the soil/H2O interface, and by aqueous photolysis in
the presence of photosensitizers. Ground water contamination is not likely from use on
the primary crop, rice, and surface water is not likely to receive significant amounts of
thiobencarb unless there is excess rainfall soon after application, leading to uncontrolled
runoff. When used on the rice, thiobencarb is more likely to be found in the soil than in
the paddy water. Furthermore, greater quantities of thiobencarb are associated with soil
when appUed preflood to soilrather than.instanding water. The parition of thiobencarb
associated with soil was approximately 10 times more when applied preflood to soil than
when applied to standing water, primarily since thiobe^^^
' '' '"''"' "" ;'' _f;, _;" Jio'floodmg. As a result,_ sensitized aqueous photolysis is expected to be more significant
as a dissipation route when thiobencarb is applied to water than when it is applied to dry
. a
-------
In two field studies in California where granules were applied into standing water,
the half-lives in flood water were 8.7 days (guideline study) and 4.5 days (literature
review, Ross and Sava,. 1986). The half-lives in hydrosol were 153 and 56 days,
respectively. The median ratios of soil:water thiobencarb residues were 5.6:1 and 6.6:1.
Thiobencarb moderately accumulated in bluegill sunfish with maximum
bioconcentration factors of 128x, 639x, and 41 Ix for edible (muscle) tissue, nonedible
tissue, and whole fish, respectively. Depuration is rapid, with 93-95% of the accumulated
[14C]residues being eliminated from the tissues in three days. The degradates 4-
chlorobenzylmethylsulfoxide, thiobencarb sulfoxide, desethylthiobencarb, and 2-
hydroxythiobencarb were identified in edible and nonedible tissue. Based on results of
crop accumulation studies, thiobencarb does not appear to accumulate in plants.
b. Environmental Fate and Transport
(1) Degradation
(a) Hydrolysis
Thiobencarb is stable1 to degradation by hydrolysis. Thiobencarb did not degrade
in sterile aqueous buffer solutions (pH 5, 7, and 9) that were incubated in darkness at 25
ฐC for 30 days. The guideline requirement (GLN 161-1) is fulfilled. (MRID 41609012)
(b) Photodegradation
In Water
Thiobencarb photodegraded, with a calculated half-life of 190 days in a
nonsensitized sterile pH 7 aqueous buffer solution at 25 ฐC. Photodegradation was more
rapid in a solution photosensitized with acetone with a half-life of 12 days. Thiobencarb
did not degrade in the dark control (non-sensitized). The photoproducts identified in the
nonsensitized and sensitized irradiated solutions were 4-chlorobenzoic acid, 4-
chlorobenzaldehyde, 4-chlorobenzyl alcohol, and N,N-diethyl-4-
(chlorobenzylthio)carbamate S-oxide (thiobencarb sulfoxide). In the non-sensitized;./
irradiated solution, no photoproduct exceeded 3.9 % of the applied. The major
photoproducts in the sensitized solutions were 4-chlorobenzoic acid and 4-
chlorobenzaldehyde, reaching maximum amounts of 56 and 29.4 % of applied,
respectively. 4-Chlorobenzyl alcohol reached 6.1-6.7 % of applied by 14-30 days and
thiobencarb sulfoxide reached a maximum amount of 5 % by 14 days, and declined to 1..1
% by 30 days. One additional degradate, O-[(4-chlorophenyl)methyl]diethyl carbamate
(bencarb), was isolated in the irradiated sensitized solution and reached 17.7 % by 21
days, and declined to 12.4 % by 30 days. The guideline requirement (GLN 161-2) is
fulfilled. (MRID 42257801)
53
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On Soil
Based on 30-day studies, thiobencarb slowly photodegraded on sandy loam soil,
irradiated under natural sunlight at Richmond, California with an extrapolated half-life of
168 days, and degraded in the dark controls with a calculated half-life of 280 days. In the
study, no volatile or non-volatile degradates exceeded 1.3 % of applied. Non-extractable
residues did not exceed 8.7 % in the irradiated samples and 5.7 % in the dark control
samples by 26 days. The guideline requirement (161-3) is fulfilled., (MRID 41215312)
Photodegradation in Air
No data were reviewed. This study was waived (4/29/91) because volatility is not
a significant dissipation route in the environment for thiobencarb.
(c) Aerobic Soil Metabolism
Thiobencarb is moderately persistent in soils in California and Louisiana that
support rice production. The calculated half-lives in three soils were 27-58 days in two
acceptable studies (MRID's 43300401, 00040925). One supplemental study (MRID
431212Q1) provided additional information that supported the results of the two acceptable
studies.""'",, , ', , '" ',, " '.' ""', "" '''",'"",'."'','."., ."" , ,",'" "
Thiobencarb appeared to degrade in a biphasic pattern with half-lives of 58 days
for 0-56 days after treatment and 137 days for 56-366 days in a Stockton Clay Adobe soil
from California (24 % sand, 30 % silt, 46 % clay, 2.2 % OC, pH 6.1). The biphasic
pattern may be a result from thiobencarb binding to soils. After the 56-day sampling
interval, the rate of degradation was significantly slower. There were six non-volatile
degradates detected in.the: study, but none of;the degradates exceeded 5.4 % of the applied
dose (3.1 ppm). The primary degradates were CO2, reaching 42.5 % of the applied by
the end of the study (366 days), and nonextractable residues, reaching 23.2 >% by the end
of the study.
The reviewer-calculated half-lives in a clay soil from Biggs, California and a silty
day loam from Crowley, Louisiana were 37 and 27 days, respectively. The clay soil (18
% sand, 26 % silt, 56 % clay, 1.13 % OC, pH 4.6, CEC 32.5 meq/lOOg) and the silty
clay loam from Crowley, LA (3 % sand, 69 % silt, 28 % clay, 0.79 % OC, pH 5.8, CEC
14P5 mga/iOOg) were representative soils from major rice growing regions of the U.S.
Evolved CO2 increased to 54-77 % by 1 year. The extractable, non-volatile degradates
did not exceed 5 % of applied, and bound residues increased to a maximum of 42 % of
applied by 1 year. (GLN 162-1, MRID 00040925)
In a supplemental guideline study using a California soil, CO2 increased to 8.6 %
of applied by 132 days, and bound residues increased to 23.3 % of applied. The soil was
a Stockton Clay Adobe (18 % sand, 27 % silt, 55 % clay, 2.0 % OC, pH 6.0). This was
54
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intended to be an aged soil mobility study, but determination of meaningful Freundlich
coefficients was not possible due to the stability of thiobencarb. Thiobencarb decreased
from 87.1 % at time zero to 57.2 % by 132 days of incubation. The calculated half-life
was 250 days. Thiobencarb slowly mineralized in soil without forming significant
quantities of non-volatile degradates. (GLN 163-1, MRID 43121201)
(d) Anaerobic Soil Metabolism
Anaerobic soil metabolism studies were not required because the registrant
submitted an anaerobic aquatic metabolism (GLN 162-3, MRID 00040925) instead. (GLN
162-2, waived)
(e) Anaerobic Aquatic Metabolism
Thiobencarb is stable under anaerobic aquatic conditions. The registrant-calculated
half-life in sediment was 1962 days (5.4 years) (MRID 43252001). In supplemental
guideline studies, the registrant-calculated half-lives were 243 days in a sediment from
Louisiana and >181 days in a sediment from California (Walker et al., 1988).
Supplemental information from open literature reported half-lives of 9-517 days in
sediment, and 31 and 82 days in non-sterile and sterile water, respectively. The 9-day
half-life in sterile sediment reported in the literature study is not consistent with the other
data that show thiobencarb to be more persistent in sterile test conditions-than in non-
sterile conditions. The guideline (GLN 162-3) is fulfilled. (MRID 43252001)
Anaerobic metabolism of thiobencarb was measured in clay sediment from the
Sacramento Valley (Stockton Clay Adobe,: 1.6 % sand, 32 % silt, 52 % clay, 2.0 % OC,
pH 6.1) and water from the Sacramento River (pH 7.1, 44 mg/L alkalinity, total hardness
of 50.4 mg/L CaCO3). The extrapolated half-life was 5.4 years (1962 days). The
percentages of total thiobencarb residues in the sediment were 66.2 % at time zero, 76.6-
86.8 % from 7-272 days, and 65 % by 363 days. Residues in water decreased from 20
% at time zero to 3.1-7.5 % from 7-272 days, and then increased to 23.3 % by 363 days.
Volatile residues did not exceed 0.9 % of applied. The degradate 4-chloro-benzoic acid
reached 14.'2 % of the radioactivity, in water at 70 days, which was only 0.3 % of the
applied. It then decreased to 1.3-12.1 % of the radiocarbon in water (<0.3 % of the
applied). No other degradate.reached 10 % of the radiocarbon in water. The guideline
requirement is fulfilled. (GLN 162-3, MRID 43252001)
In a study that was considered supplemental because of deficient material balance,
the registrant-calculated half-lives were > 181 and 243 days in clay soil (Biggs, California,
18 % sand, 26 % silt, 56 % clay, 1.13 % OC, pH 4.6, CEC 32.5 meq/lOOg) and silty
clay loam (Crowley, Louisiana, 3 % sand, 69 % silt, 28 % Clay, 0.79 % OC, pH 5.8,
CEC 14.5 meq/100g)/water systems, respectively. Non-volatile degradates and CO2 did
not exceed 3.8 .%, indicating thiobencarb partitioned primarily into the sediment.
55
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Unextracted residues increased to 42.8 % in the clay soil and 27.8 % in the silty clay loam
by 364 days. (GLN 162-3, MRID 00040925)
Walker et al. (1988) determinedthe first order biotic and abiotic degradation rate
constants for 14 pesticides (including thiobencarb) in estuarine water and sediment/water
slurry systems (sterile and npn^sterile)""'] Trie half-lives in non-steriie and sterile sediment
ranged from 9-517 days, fhe half-lives in sterile water and non-steriie water were 31.5
and 82 days, respectively. (Walker et 'al., 1988)
i ,,i' ' ' i; iiiiifiii I.;*1:,,, < , ii " , "'' i , ,ni >: \ i \ H. n iii"',,i,'iiMir1:1 ,i 'i'1" '.V' A:, , I'^'Wiii. v'LiJh1, ',': '?. \'t MI: ik'j I'l';"", ' 'i , ,. "- ,1 ',',ป ' i "
Chen et al. (1982) created a model aquatic ecosystem and applied 14C-thiobencarb
to determine its partitioning in the laboratory environment. It was not possible to calculate
a half-life because of limited sampling. By the end of the experiment (23 days),
thiobencarb partitioned mostiy into sand (23.2 % of applied) and to a lesser extent into
water aid biota (2.7 and 0.31 % of applied, respectively) . The authors attributed the low
recovery of radioactivity to volatility, photodecomposition, and microbial decomposition.
(Chenetal., 1982)
(f) Aerobic Aquatic Metabolism
Thiobencarb was stable to aerpbic aquatic metabolism in a clay soil/water system
from the rice-growing area of California. The"'guideline requirement (162-4) is fulfilled.
(MRID 42015301)
(2) Mobility
Unaged Mobility (Batch Equilibrium)
Thiobencarb was moderately mobile to immobile in five soils. Freundlich K^
values ranged from 5.4 to 20.1 in the tested soils, and Koc's ranged from 384 to 1435 (see
below Table). The unaged portion of the guideline requirement (GLN 163-1) is fulfilled.
(MRID 41215313)
Table 23. Results of aged mobility studies with thiobencarb.
Sofl Texture
:"(%OQ ; ";:;;";
Sandy Loam (0.5)
Loam (1.9)
Silty Clay (1.5)
Clay Loam (1.1)
SUt Loam (1.4)
Freundlich
Kjj,
5.4
7.3
9.3
11.3
20.1
Freundlich
Koc^
1084
384
618
1027
1435
Freundlich Kte
14.3
21.7
28.8
46.7
94.5
Freundlich
Koc*.
2860
1142
1920
4245
6750
.N (slope values) for
adsorption and desorption
0.8, 1.0
1.1, 1.1
1.1, 1.1
1.2, 1.2
1.0, 1.1
Aged Mobility
Based on batch equilibrium experiments, the degradate 4-chlorobenzoic acid was very
mobile to moderately mobile in the tested soils with Freundlich Kads of 0.7-3.3 (See below Table).
56
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Mobility generally decreased with increasing clay content, increasing organic matter content, and
increasing cation exchange capacity. The aged portion of the guideline requirement (GLN 163-1)
is fulfilled. (MRID 43150601)
I ' ' ' ' . S
Table 24. Results of aged mobility studies with thiobencarb
Soil Texture {% QC) .
Sandy Loam (0.88)
Loam (0.76)
Silt Loam (0.88)
Clay (2.0)
Ereundlich
K.ab
0.74
1.0
1.2
3.3
Freundlich
Kocaas t
84
130
140
160
Freundlich
^to
2.2-
1.9'
2.4
8.3
Freuadlich
'Koc4K
250
250
280
420
N (slope values) for
adsarptipu and desorption
1.6, 1.6
1.6, 1.5 -
1.6, 1.6
1.3, 1.2
Laboratory and Field Volatility .
Volatility testing was waived (4/29/91) since volatility is not a significant means
of dissipation of thiobencarb. (GLNs 163-2 and 163-3, waived, see also GLN 161-4)
(3) Accumulation
Accumulation in Irrigated Crops .
Thiobencarb was detected (detection limit of 0.07 ppm) in the tops,of table beets
grown in plots of clay soil in California that were sprinkler-irrigated five times at 8- to 13-\
day intervals with water containing thiobencarb (Bolero 8 EC, 85 % emulsifiable
concentrate) at approximately 200 ppb.' Thiobencarb was not detected (detection limit of
0.01 ppm) in either the beet foot or in tomato fruits grown under similar conditions. In
addition, the potential degradate 4-chlorobenzylmethyl sulfone was not detected in beet
tops or roots, or in tomato fruits. In the 0- to 6-inch depth of the treated soil,, parent
thiobencarb and the degradate thiobencarb sulfoxide were 0.04-0.13 and _<_0.02 ppm,
respectively, at all sampling intervals. There was no apparent pattern of accumulation or
decline of either parent thiobencarb or the degradate. (GLN 165-3, MRID 43148201) .
Bioaccumulation in fish
Thiobencarb residues accumulated in juvenile bluegill sunfish exposed to
[14C]thiobencarb at 0.05 mg/L, with maximum bioconcentration factors of 128x, 639x,
and.411x for edible (muscle) tissue, nonedible tissue, and whole fish, respectively. The
degradates 4-chlorobenzylmethylsulfoxide, thiobencarb sulfoxide, desethylthiobencarb,
and 2-hydroxythiobencarb were identified in edible and nonedible tissue. By day 3 of the
depuration period, 93-95% of the accumulated [14C]residu.es were eliminated from the
tissues. The guideline requirement (GLN 165-4) is fulfilled. (MRID 42460401)
57
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c. Field Dissipation
(a) Terrestrial Field Dissipation
The registrant has submitted sufficient information on terrestrial field dissipation
(164-1) to do an environmental fate assessment for the 40,000 acres of vegetables in
Florida. Considering the small acreage of this use, the aquatic field dissipation study for
rice in Louisiana provided adequate information on the fate of thiobencarb under terrestrial
conditions, in addition to aquatic conditions. Therefore, terrestrial field dissipation data
are reserved for any future terrestrial uses of thiobencarb.
(b) Aquatic Field Dissipation
III III III II I ; ' , . ' , -"
In two field studies in California where granules were applied into standing water,
the half-lives in water were 8.7 days in the guideline study (MRID 43404005) and 4.5
days in the literature study (Ross and Sava, 1986). The soil half-lives determined in the
two studies were 153 and 56 days, respectively. The median amounts of thiobencarb in
soil were 5.6 and 6.6 times higher than in water, respectively. No leaching was observed
below 6 inches of depth. GLN. 164-1, MRID 42003404. The guideline is only partially
satisfied since the registrant did not provide storage stability of samples and since the
movement of water in the CA guideline study (MRID 43404005) was not described in
detail.
Thiobencarb dissipated with an observed half-life of approximately 6 days in silty
clay loam soil in Louisiana that had been planted to rice. The plot was flooded at 7 days
postfreainent; thiobencarb dissipated from the floodwater with a registrant-calculated half-
life of 5.8 days. Thiobencarb^ was not detected in the soil below 10 centimeters. The
degradates l-(((4-cMorophenyl)memyl)sulfonyl)-N,N-diemyiformamide (thiobencarb
sulfoxide) and 4-chlorobenzyl-methylsulfone were detected primarily in the upper 5 cm
of the soil and in the floodwater. (MRID 42003404)
Thiobencarb (10 G) was applied in one application by air at 4 Ibs ai/A to flooded
plots of Anita clay loam (28 % sand, 26 % silt, 46 % clay, 2.47 % OC, pH 6.1, CEC of
46). Soil cores were taken to 30 cm (1 foot) of depth throughout the study at 0-551 days
after treatment. There was one 8-foot core taken at 153 days, which was divided into
segments ranging from 5 cm at the surface to 30 cm at lower depths. Water samples were
taken at 0-92 days after treatment. Water samples were also collected from the fallow
field replicates from days 15-21 and day 27.
The half-life in soil was 20 days for the 0-92 day (flooded) sampling periods, and
was 153 days when all sampling intervals (0-551 days) were considered. The half-life in
water was 4.8 days when the 0-33 day sampling intervals were considered. (MRID
43404005)
58
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Ross and Sava (1986) studied two commercial rice fields in the Sacramento Valley.
of CA. Thiobencarb was applied at 4 Ibs ai/A using fixed-wing aircraft into standing
water when rice plants had not yet emerged (1-3 leaf growth stage). Water was held at
10.4 inches of depth for 6 days with no inflow or outflow (stagnant water). After 6 days,
the field was rapidly drained to 6.8 inches of depth with intermittent inflow and outflow!.
Water temperatures averaged 28 ฐC (82ฐ.F) for 30 days. Water, soil, and vegetation
samples were collected from four pads within each rice field. The pads were located at
the field inlet and outlet and two randomly-chosen points in between. Samples were taken
at -1, 0, 2, 4, 8, 16, and 32 days after application near the pads and where the water flow
was slower. The dynamics of herbicide dissipation were examined using a split plot
analysis or variance (ANOVA). Air, water, soil, and vegetation were analyzed using GC.
Thiobencarb was predominantly distributed between water (34.5 %) and soil (43
%), with less than 1% associated with air and vegetation. Thiobencarb water
concentrations at 0, 2, 4, 6, 8, 16, and 32 days after treatment were 79. 567, 576, 515,
367, 56, and 8 mg/L, respectively. Soil concentrations of thiobencarb were 3250 288o'
3350, 3860, 2020, 2260, and 2330 /zg/kg (ppb), respectively. Thiobencarb air
concentrations atO, 1, 2, and 3 days after treatment were 1.4, 0.9, 0.8 and 0.43 mg/m3,
respectively.; The calculated half-life in air was 2.2 days. The evaporative flux rates were
37, 8, 16, and 6 ng/cm2 h"1 at 0, 1, 2, and 3 days'after treatment, respectively.
Thiobencarb vegetative concentrations were 78, 691, 1750, 1360, 1280, 796 and 169
mg/kg ,(ppb), respectively, leading to a calculated half-life of 8,5 days using, natural
logarithm data. Concentrations in water, soil, and vegetation were significantly higher in
the holding period than in the postholding period. Water and vegetation concentrations
were stable in the holding period and only declined with time during the postholding
period. In contrast, soil concentrations did not change during either period. The mass
balance (including air, water, soil, and vegetation) increased from 41 % at 0 days after
treatment to 67-70 % by 2-6 days after treatment and then decreased to 26-27 % by 16-32
days after treatment. '
The guideline requirement (GLN 164-2) is only partially fulfilled. This guideline
can fulfilled if the field, dissipation study conducted in Louisiana (MRID 42003404) is-
upgraded by the submittal of more detailed information on the water management used at
the study site and the storage stability of the test samples. (GLN 164-2, MRID 41722504 '
42003404, 43404005).
(1) Spray Drift (Droplet Size Spectrum/Drift Field
Evaluation)
No thiobencarb specific studies were reviewed. Droplet size spectrum (GLN 201-
1) and drift field evaluation (GLN 202-1) studies are required for thiobencarb, since the
different formulations may be applied by aircraft and it is estimated that there will be
detrimental effects to non-target terrestrial and semi-aquatic plants due to drift. However,
to satisfy these requirements the registrant, in conjunction with other registrants of other
59
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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. During 1996 the Agency plans to evaluate these studies. In the interim,
and for this assessment of thiobencarb, the Agency is relying on previously submitted
spray drift data and the open literature for off-target drift rates. The estimated drift rates
at 100 feet downwind of the treated sites are 1 % at the applied spray volume from ground
applications and 5% from aerial applications. After review of the new studies the Agency
will determine whether a reassessment is warranted of the potential risks of the application
of thiobencarb products.
d. Water Resources
(1) Ground Water
The Office of Pesticide Programs (OPP) evaluates the persistence and mobility of
eac.h pesticide for ground water concerns. If the data indicate that the parent and/or
degradates are persistent and mobile, then a small-scale prospective ground water study
may be requested. The basic triggering criteria include: weight of the evidence from
laboratory and field dissipation studies indicating that the pesticide has properties and
characteristics similar to pesticides that are known to leach or have been detected in
ground water; movement of the parent or degradates 75-90 cm through the soil profile or
plow iayer in a field dissipation study; reports of dTetecSons in ground water from other
mQn|tQr|ng studies and information about toxicity. In addition, use patterns, application
rates, timing of application, potential acreage treated, depth to ground water, soil types,
hydraulic gradient, and climate are also evaluated as part of the triggering criteria.
!
Persistence, mobility, and detections in ground water are also used to evaluate a
chemical to determine whether its use should be restricted for ground water concerns. A
pesticide may be recommended as a candidate for restriction if it exceeds one or more
criteria for each of the three factors (persistence, mobility, and detections).
(a) Persistence and Mobility
Thiobencarb was evaluated for persistence and mobility in relation to its potential
to leach to ground water. Below is a summary of that evaluation.
60
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Table 24. Mobility and Persistence of Thiobencarb Relative to Restricted Use Criteria
Factor
Persistence
Mobility
1
2
' 3
4
5
6
7
Characteristic
Field dissipation half-life
Lab-derived aerobic soil
metabolism half-life
Hydrolysis half-life
Photolysis half-life (Soil)
Soil adsorption: Kd
Soil adsorption: K^
Depth of leaching in
field dissipation study
Restricted Use
- Criteria
> 3 weeks
> 3 weeks
< 10% in 30 days
< 10% in 30 days
< or = 5 ml/g
< or = 500 ml/g
75 cm
"" Reported Values* ,
8, 21.9 weeks (56, 153 days)b
3.9 -8.3 weeks (27 - 58 days)
Stable
50% in 168 days (calculated)
5.4 -20.1 ml/g .
384,618, 1024 - 1435 ml/g ,
15cmb
b Because thiobencarb is used almost exclusively on rice, no terrestrial field dissipation studies were submitted by the
registrant. Aquatic field dissipation studies were conducted to address this use. The half-lives reported are aquatic- field
dissipation for soil. Refer to Section C.2.b. of the Agency RED chapter for additional data.
(b) Degradates and Binding
The aerobic metabolism studies found that, after one year, the degradation to
carbon dioxide and binding of residues to soil were significant pathways for dissipation
of thiobencarb (see Section C.2.b.). Carbon dioxide accounted for 42-77% of the applied
and bound residues accounted for 23-42% of the applied. Literature data reported that the
thiobencarb in the soil slowly mineralized without forming significant quantities of non-
volatile degradates. This will significantly reduce the amount of thiobencarb available to
leach through the soil profile. ,
(c) Ground Water Detections
The Agency has limited monitoring information for thiobencarb in ground water
in the United States. The "Pesticides in Ground Water Database" (Hoheisel et al., 1992)
reports sampling for thiobencarb in 270 wells in California and 65 wells in Missouri.
Two detections of thiobencarb in ground water were reported in Missouri, these were very
low (0.2 - 0.3 ppb). A summary of this is presented below.
Criterion
Detections
Detections
Characteristic
Number of wells per state with detections
Number of counties with detections >
10 % of reference point
Restricted tfse Criteria
25 wells in 4 or more states or
3 counties at > 10% of MCL or
HAL
.Reported Detections
2 wells in 1 state'
No MCL or HA
Established
61
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"I":1 " :'' ' "I1.""."." .'.." '.!!'.' (d) Restricted Use
Thiobencarb met the persistence and mobility triggers for classification as a restricted use
chemical for ground-water concerns, but not the detections triggers. The Agency believes that
ground water concerns do not warrant use restrictions.
(e) Ground Water Reference Points
There is no MCL established for thiobencarb residues in drinking water. The lifetime
Health Advisory for thiobencarb also has not yet been established, but an estimated Health
Advisory can be calculated from the Reference Dose. The Agency has established the RfD of
thiobencarb at 0.01 mg/kg/day.
The Agency estimated the lifetime HA for thiobencarb to be 70 ppb. This was calculated
from the Reference Dose as follows:
Assumed: Adult with.body weight of;701 kg consuming 2 L water/day
RfD for thiobencarb...=. 0,01 mg/kg/day
RSC = Relative source contribution, assumed to be 20%
DWEL = (RfD) ("70 kg) = (0.01 mg/kg/day) x 70 kg = 0.35 mg/L
(2L/d) (2L/d)
Lifetime HA = DWEL x RSC = 0.35 mg/L x 0.20 = 0.07 mg/L = 70 ฃtg/L (ppb)
(f) Ground Water Concerns
Thiobencarb is slightly persistent in water, generally not very mobile, tends to bind
to soil organic matter, and doesn't desorb. The Agency has estimated the Lifetime Health
Advisory for thiobencarb residues in drinking water to be 70 ppb. Thiobencarb also has
low acute '^mammalian toxicity. Based on the limited data available and very low
concentrations found in ground water, there is no indication that thiobencarb
concentrations in ground water would exceed the estimated HA of 70 ppb.
The principle use of thiobencarb is rice in the lower Mississippi Valley and the
Central Valley of California. Rice fields are usually underlain by a clay layer to restrict
water movement through the soil and help contain the water in the flooded field. This clay
layer will significantly limit the amount of leaching that occurs in the rice fields.
Although thiobencarb does exceed several of the criteria for restricted use, the
Agency does not consider thiobencarb to be a candidate for restricted use due to ground
water concerns. The Agency does not consider thiobencarb to be a concern in ground
wafer, nor a human health concern from residues in drinking water that are derived from
ground water.
62
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(2) Surface Water
Environmental fate information indicates thiobencarb is. nonrpersistent4 in the
water column (aquatic field dissipation half-lives ranging from approximately 6 to 9 days).
It is stable to degradation from abiotic hydrolysis; however, degradation via aqueous
photolysis with photosensitizes was shown in the laboratory studies. The vapor pressure
and, Henry's Law constant.indicate thiobencarb will not volatilize readily from surface
water environments. Based on the FreundlicTi adsorption coefficients (Kads range: 5.42-2(3
ml/g), thiobencarb adsorbs to soil and sediment particles and may be transported on
entrained sediment in surface runoff. Partitioning of thiobencarb onto soil or sediment
was demonstrated in three aquatic field dissipation studies where, thiobencarb
concentrations on soil were approximately 5 to 64 times greater than water concentrations.
However, the results of field monitoring studies indicate thiobencarb can be transported
primarily via dissolution in runoff water if sufficient rainfall occurs immediately foUowing
field application. In surface waters, thiobencarb dissipates principally by binding to
sediment, and degrading by sensitized aqueous photolysis. Mineralization is also known
to occur at the soil-water interface in rice fields. This is aerobic degradation.
Thiobencarb has the potential to contaminate surface water from releases of rice paddy
water which closely follow field application, or from spray drift associated with aerial or
ground spray application.
Thiobencarb is not currently regulated under the Safe Drinking Water Act
(SDWA); therefore, a Maximum Contaminant Level (MCL) is not established. It is
classified as category m for oral acute toxicity. The estimated .lifetime Health Advisory
level (HA) is 70 mg/L using the Reference Dose of 0.01 mg/kg/day. Public water supply
systems are not required to sample and analyze for thiobenearb.
In the EPA Office of Water's STORET database, thiobencarb detections in surface
waters were reported for .filtered water samples only (detections limits varied from 0.002-
0.008 mg/L). Detections qf thiobencarb were listed'for 8 states: California, Georgia,
Maryland, North Carolina, Oregon, Oklahoma, Texas, and Washington.5 Thirty-nine
positive detections were reported for 3,130 samples (approximately 1 %) with a maximum:'-':-'X-
concentration of 0.24 mg/L (7/22/92 and 8/26/92; Klamath Falls, OR) and a mean-'?
concentration of 0.10 mg/L. Whole (i.e., unfiltered) water samples did not find detectable .
levels of thiobencarb. Surface water concentrations for the field monitoring studies are
several orders of magnitude greater (approximately 100 to 3000 times larger) 6than the
detections reported in the, STORET database. The sources of this variation are not known;
4 Based on the criteria established by McEwen and Stephenson (1979,), ''.".
The Agency does not know why thiobencarb was detected in these states since, with the exception of California',: ''. !X'"'".:""
registered uses of thiobencarb should not occur within these states. ' '" "'"'' '
63
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however, the filtered sample results (0.7 mm filters) in the STORET data suggest very low
concentrations of thibb'encafb in the aqueous phase of surface water samples. This finding
is consistent with the partitioning of'thibbencarH onto sediment which would lower the
concenfiations in the aqueous phase. It is not clear whether the results from the field
monitoring studies were determined from filtered or unfiltered water samples. Additional
surface water monitoring data are described in Section 3a(2)(b).
Aquatic EEC modeling for rice uses was not conducted because the Agency
currently does not gave a" computer simulation" model which will estimate these
concentrations. For the lettuce, endive and celery uses, the GENEEC model was used to
complete a Tier 1 exposure assessment (Table I). The range of aquatic EECs was 140
mg/L for the 6 Ib a.i. application rate and 180 mg/L for the 8 Ib a.i. application rate. The
,^,g^l ^^.gg^v ฃ-..ฃ j^Qj-Q-y'^gyj- for eac'Epound increase in thiobencarb.
Comparison of the initial EECs with the 21-day and 56-day EECs indicates thiobencarb
dissipates in the pond water at an approximate rate of 0.4-0.6 mg/L/day.
Increased transport time to the water intakes will allow greater binding of
thiobencarb to suspended solids and/or sediments. Any thiobencarb that may reach surface
water will be predominantly bound with suspended solids and sediments. Standard
coagulation and flocculation processes used in these plants should remove most of the
suspended solids an"3 'sediments ""frbm""the water |" thereby removing most of the potential
risk of thipbencarb in drinldng water. ' i '
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
(1) Background Information
III 111 I ^1 I II I l || || || '.,..:,,' '. ": .; .
Risk Quotients and the Levels of Concern
Levels of Concern (LOCs) are criteria used to indicate potential risk to nontarget
organisms. Exceeding the criteria indicate that a pesticide, when used as directed, has the
potential to cause undesirable effects to nontarget organisms. Two general categories of
LOG (acute and chronic) exist for each of the four nontarget fauna! groups, and one
category (acute) exists for each of two nontarget floral groups. To determine if an LOG
has been exceeded, a risk quotient is derived and compared to the LOG. A risk quotient
is calculated by dividing an appropriate exposure estimate, e.g. the estimated
environmental concentration (EEC), by the appropriate toxicity test effect level. The
acute effect levels are: ;
:!':,""' :'*!-I ':': -r EC^'(terrestrialplants)
.-?+ EC50 (aquatic plants and invertebrates)
LC50 (fish and birds)
64 ...
rVr li1 >,'!', -.fit", I!1!;! , "iriHM
-------
~ LD50 (birds and mammals)
~ ECOS or NOEC (endangered plants)
The chronic effect levels are the: '
NOEC (avian and mammal reproduction studies)
NOEC or MATC for aquatic species.
When the RQ exceeds the LOG for a particular category, risk is presumed. Risk
presumptions, along with the corresponding LOCs, are tabulated below.
Table 26. Risk Quotients and LOCs for Animals
Endpoinr
Risk Quotient (RQ)
LOCT
Birds
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic High Risk
Chronic Endangered Species
EEC/LC50 or LD50/sq. ft or LD50/day
EEC/LCSO or LD50/sq. ft or LDso/day (or LD50 < 50
mg/kg)
EEC/LC50 or LD50/sq. ft LDso/day
EEC/NOEC
EEC/NOEC
0.5
0.2
- 0.1
1
1
' " Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
EEC/LCSO or LD50/sq. ft or LD50/day
EEC/LCSO or LD50/sq. ft or LD50/day (or LD50 < 50
mg/kg) ,
EEC/LCSO or LD50/sq. ft or LD50/day
Aquatic Animals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic High Risk
Chronic Endangered Species
EEC/LCSO or EC50
EEC/LCSO or ECSO ,
EEC/LC50 or EC50
EEC/MATC or NOEC
EEC/MATCorNOEC
0.5
0.2 .
0.1
0.5
0:1
0.05
1
1
Table 27. Risk Quotients and LOCs for Plants
Endpoint
.Risk Quotient {.KQ)
Terrestrial and Semi-Aquatic Plants
Acute Plants
Acute Endangered Species
EEC/EC^
EEC/EC05 or NOEC
Aquatic Plants
Acute Plants
Acute Eridangered Species
EEC/EC50,
EEC/EC05 or NOEC . ' '
LOG
1
. 1
1
1
65
-------
I.,'.''''ซ" ' IIL :|ii
At this time, The Agency has no procedures for assessing chronic risk to plants,
acute or chronic risks to nontarget insects, or chronic risk from granular/bait formulations
to mammalian or avian species.
Thiobencarb Use Patterns Addressed in Risk Assessment
The majority of thiobencarb use (95%) is to control terrestrial and aquatic weeds
in rice production. The maximum label use rate on rice is 4 Ib ai/A, and the average rate
is approximately 3 Ib ai/A. Application may be by aircraft or ground equipment. For
rice grown in the Gulf Coast and Mississippi River Valley, thiobencarb is usually applied
as a liquid (EC formulation) to nonflooded fields. "Dry-seeded" rice is frequently grown
in this area, in which seeds are sowed and grown in dry seed beds for several weeks
before flooding. If there is no rainfall, fields are irrigated with a small volume of water .
(i.e. flushed) to'promoteseed germination. Some rice in this area is "water-seeded",
meaning that seeds are applied to water in flooded fields. In this part of the country,
thiobencarb is usually applied to fields before they are flooded. Fields are then flooded
for seeding with rice. These floods are normally dropped temporarily after seeding to
allow rice seedlings to grow, resulting in a discharge of water. In California, the majority
of rice grown is water-seeded with a continuous flood. Unlike the southern region,
thiobencarb in California is almost always applied as a granule to water in flooded fields.
A small percentage of rice farmers in California use "piii-point flood" culture, in which
case thiobencarb may be applied as a liquid to dry-ground before fields are flooded.
California state regulations prevent rice farmers from discharging tailwater from rice
fields for 4 to 30 days after application.
Additionally, a relatively small amount of thiobencarb is used on lettuce, endive,
and celery. Registrations for these uses are restricted to Florida. The maximum label rate
is 6 Ib ai/A for lettuce and endive "and 8 Ib ai/A for celery Application is by boom
sprayers. '""" " "' '
(2) Exposure and Risk to Nontarget Terrestrial Animals
(a) Birds
Liquid Applications- Acute and Chronic Risk
For thiobencarb products applied as a liquid to soil, risk is assessed by comparing
LG;o v?!16? to estimated residues (i.e. EECs) on dietary food items immediately following
application. The table below giv&faepi^cied'Q^iay maximum and mean residues of
thiobencarb that are expected to occur on selected avian or mammalian dietary food items.
66
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Table 28. Maximum EECs on Avian and Mammalian Food Items for Uses of Thiobencarb.
Use Site ' \
Rice
Lettuce and Endive
Celery
Maximum Application
- Rate(lbsa.i./A)
4
'6
.- 8
..Maximum. EEC (ppm)
Short gras$
960
1440
1920
.Long grass
440
660
880
Broadleaf. plants and insects
540
810
1080
Fruit
60
90
120
, In an avian dietary LC50 test with the northern bobwhite (Ace. No. 241483), no
mortality occurred at the maximum test level, 5620. ppm. Environmental concentrations
are predicted to be much less than 5620 ppb. The acute risk to birds from all uses of
thiobencarb is minimal. No acute effects to threatened and endangered species are
expected. ,
The chronic risk quotients for liquid applications are given below.
Table 29. Avian Chronic Risk Quotients (RQs) for Liquid Applications Based on a
Mallard Duck NOEC and Maximum EECs.
Crop
Rice
Lettuce and
Endive
Celery '
Maximum-
Application Rate
(Ibs a-i/A) -
4
6
8
Pood Items
Short grass
Long grass
Broadleaf plants and insects
Fruit
Short grass
Long grass
Broadleaf plants and insects
Fruit '
Short grass
Long grass
Broadleaf plants and insects
Fruif
Maximum
EEC
(ppm)' I
960
440
540
60 .
1440
660
, 810
90
1920
880
1,080
120
NOEC
{ppm)"
100
100
100
100
100
100
100
100
100
100 .
100
100
Chronic RQ.
(EECVNOEC)
9.6
4.4
5.40
0.6
14.4
6.6
8.10
0.9
19.2
8.8
10.80
1.2
Number of
Bays EEC
> NOEC
29
19
, 21
0
34
24
26
0
37
27
30
, 3
In addition to the magnitude of the RQs, chronic risk can be assessed by estimating
the duration .when EECs are expected to be high enough to possibly cause effects in birds.
This duration is based on the magnitude of the initial EEC and the rate-of dissipation. The
dissipation of thiobencarb from foliage was estimated from data collected in a biological .
field study conducted at Halls Bayou, Texas (Ace..No. 241484). Thiobencarb residues,
were measured from broadleaf weeds and sedges collected 12 m downwind of the edge of
the field on 0, 7, 14, and 21 days after application. The calculated foliage half-lives for
broadleaf weeds and sedges were 5.4 and 8.6 days, respectively. These values are
67
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consistent with those estimated for other pesticides (Willis and McDowell, 1987). The
more protective value of 8.6 days was used in the risk assessment. Assuming a first-order
rate of dissipation, EECs are predicted to exceed the> mallard NOEC for up to 37 days,
depending on the use rate and type of plant.
" ' "' ", :!! ':,' $' : ' ,
Most of the chronic risk quotients exceed the LOG of 1 for use on rice, lettuce,
endive, and celery. The use rate would have to be reduced to 0.4 Ib/A, one-tenth the
currentpaximum label rate for rice, to reduce all of the chronic RQs to below,the LOG.
Furthermore, the maximum'BECs'for''all food'types except fruit exceed the mallard
NOEC for relatively long durations, generally three weeks or more. These results indicate
that all uses of thiobencarb pose a risk of causing chronic effects to birds and may cause
chronic adverse effects to threatened and endangered bird species.
Granular ApplicationsAcute Risk
A granular formulation is used only when thiobencarb is applied to flooded rice
fields. Most of the granules will fall onto the water surface and sink to the bottom. These
granules would not b"e accessible to many birds, although they possibly could be ingested
by waterfowl and sandpipers which feed off the bottoms of the flooded fields. A small
portion of the granules may fall on levees built around and within rice fields or get caught
in emerging rice plants. These granules could be available for birds to consume. Some
exposure of granular pesticides to birds is therefore expected, but the overall degree of
exposure is probably less than when thiobencarb is applied on dry fields.
iThiobencarb^has, very low acute foxicity to birds.. In an acute single-dose test with
the northern bobwhite, a dose of 1938 mg ai/kg Bwt resulted in no mortality or overt signs
of toxicity (MRID 42600201). The Agency expects that the risk of acute effects to birds
from exposure to granular thiobencarb is minimal.
Granular ApplicationsChronic Risks
The Agency currently does not have a procedure for assessing the chronic risk
posed by granular applications.
(b) Mammals
ii i i , . '' ' .
Acute hazard to small mammals was addressed using the acute oral LD50 value for
the rat converted to an estimated LC50 value for dietary exposure. The estimated LC50 was
derived using the following formula:
LC50 = LD50 x body weight (g) / food consumed per day (g)
68
-------
Acute risk to mammals was assessed by calculating RQs for three representative
species: the meadow vole, the field mouse, and the least shrew. Estimated mammalian
LC50 values for these three species of small mammals are presented below:
Table 30. Estimated Small Mammal Dietary Exposure (Based oh an LDSO = 1080 mg/kg).
Small Mammal \
Meadow vole
Adult field mouse
Least shrew
Body Weight '(g)
46
13
5
Percent of Weight Eaten
Per Day
61 %
16 %
110 %
Pood Consumed i
Per Day
-------
Table 32. Mammalian Chronic Risk Quotients (RQs) for Liquid Applications Based on a Rat NOEC
and Maximum EECs.
Crop
Maximum
Application Rate
(Ibsa.i./A) ;
Food Items
Maximum
EEC
NOEC
Short grass
960
20
48
48
Rice
Long grass
440
20
22
38
Broadleaf plants and insects
540
20
27
41
Fruit
60
20
14
Lettuce
and
Endive
Short grass
1440
20
72
Long grass
660
20
33
43
Broadleaf plants and insects
810
20
41
46
Fruit
90
20
19
Short grass
1920
20
96
57
Celery
Long grass
880
20
44
47
Broadleaf plants and insects
1080
20
54
50
Fruit
120
20
22
All of the chronic RQ for mammals exceed the LOG of 1 for use on rice, lettuce,
endive, and celery. Except for exposure on fruit, all RQs are very high (22 or greater).
Also, EECs on wildlife foods are expected to persist at levels greater than the mammalian
NOEC for many days. These results indicate that all uses of thiobencarb pose a risk of
causing chronic effects to mammals and may cause chronic adverse effects to threatened
and endangered species of mammals.
The specific responses of the tested organisms in the study yielding the 20 ppm
NOEL were reduced weight gain and food consumption, food efficiency, and increased
blood urea nitrogen at 100 ppm, the next highest test level above 20 ppm. In another
study, no reproductive effects were observed at dietary concentrations as high as 2000
ppm. Thus the chronic risk to mammals relate to growth and physiology. Available data
do not suggest high risk of reproductive impairment to mammals at any application level.
GranularAcute Risks
A granular formulation is used only when thiobencarb is applied to flooded rice
fields. Most of the granules will fall onto the water surface and sink to the bottom. These
granules probably would not be accessible to most mammals. The active ingredient of
',,!!,' ill,!1 i . , ,"n i "'P. II Mllii; Illf", ,ihi,l, ,'f I ''Ik,, I1 1 "Ill',I 'IIHI II'IMIIII I III ,'i, 'i" 'ill,, '" ,lii, I,' ,,,! ,, II il 'I,' ' 'II, I'I' ill , " , " I , I
these granules would disperse into the water, and mammals could then be exposed by
drinking""this water. But, considering the large degree of dilution that would take place
and the low mammalian tpxicity of "tibdbbehcafb," this would pose minimal risk to
mammals. The primary route of exposure to mammals from granular thiobencarb
probably would be from ingestion of granules that fall on the levees within and around the
",11!-*!!
ir.K
-------
To be protective, the values were selected to maximize calculated exposure estimates.
GEECs based on runoff from a single application on a 10-hectare field to a 1-
hectare x 2-meter deep water body are given below.
Table 33. Generic Estimated Environmental Concentrations (GEECs) for Aquatic Exposure.
Use Site
Celery (FL)
Lettuce and
Endive (FL)
Application Method
Ground, unincorporated
Ground, unincorporated
Maximum Application
Rate(}bsa.L/A) \
8
6
Number of
Applications
1
1 .
Initial (Peak)
EEC(pp-b) !
186
140
21-day EEC
)
173
130
56-day EEC
fepb)
157
118
(b) Measured Aquatic Concentrations
The Agency used aquatic concentrations measured in field studies and monitoring
projects to estimate the exposure of aquatic organisms from use of thiobencarb on rice.
Measured water concentrations were available from two biological field studies performed
in Texas (MRID 92182086 and 92182089, Ace. No. 241484), two environmental fate field
studies performed in Louisiana and California (MRID 42003404 and 43404005),
monitoring data.from California (MacCoy et al., 1995, MRID 43359700), and studies
reported in the open literature (Ross and Sava, 1986; Watanabe et al., 1982). While data
from all of these sources were reviewed, the risk assessment for dry-seeded rice in the
Southeast was based primarily on data from the,two biological field studies and the risk
.assessment for water-seeded rice in California was based on data from the monitoring
programs. These sources were most relevant because they provided measured
concentrations of thiobencarb residues in off-site bodies of water, rather than in the rice
fields themselves.
Dry-Seeded Rice in the Southeast
The two biological field studies provide examples of residues that can result in
slow-moving bodies of water that receive drainage from surrounding dry-seeded rice fields
where thiobencarb is applied. The Agency considers both Halls Bayou and the canal
studied near Matagorda, Texas to be representative of small brackish waterways that occur
in the rice-growing region of the Gulf Coast. These field studies will also be used in the
risk assessment to represent freshwater habitats of the Mississippi Valley since no study
specific to this region is available. The 1978 Stream Evaluation Map for the state of
Texas categorizes the section of Hall's Bayou where the field study was located as
Category I, a "highest-valued fishery resource". The drainage ditch in the Matagorda
study was a 120-130 ft wide permanently flooded canal that is also considered to be a
biologically significant habitat. Biological sampling in both studies found these waterways
are abundant and diverse in fish and invertebrate life.
The greatest exposure from dry-seeded rice culture probably results from the first
flush or heavy rainfall that occurs after thiobencarb has been applied. Pesticide residues
72
-------
in the soil are dissolved in this water as it passes over the field and then discharged into
an aquatic habitat. As demonstrated in the Hall's Bayou field study, unplanned flushes
resulting&6in''fairtfall" usually resultiri greater residues'in off-site aquatic habitats than do
planned flushes. Planned flushes usually occur one to two weeks after application,
allowing much of the pesticide to bind to the soil. Furthermore, since rice farmers
normally try to use the minimal amount of water required to adequately wet the soil, little
water is normally discharged in a planned flush. On the other hand, rainfall may occur
soon after the pesticide is applied, and if it is intense, may result in a large volume of
water beiTig discharged from'the'field.
The biological field study that collected water samples from Halls Bayou, Texas
[see section C.l.b(7)], provides an example of a near worst-case scenario. . Halls Bayou
is a long narrow waterway that meanders through rice-growing areas in the Texas coastal
plane. During the field study, a very heavy rainfall event (3.23 inches in 24 hours)
happened to occurred on the same day that thiobencarb was applied, resulting in unplanned
release of water from rice fields. The measured concentrations of thiobencarb in samples
taken this day were as great as 8900 ppb in the field outflow and 690 ppb at the point
Where a ditch draining from the fields discharged into Hall's Bayou. Heavy rainfall of this
magnitude is common in the Gulf Coast region, often occurring several times in the same
location during the spring. However, the Agency believes that these thiobencarb
concentrations represent near the upper bound of concentrations that are likely to occur
in aquatic habitats for the following reasons: 1) rainfall occurred on the same day that
pesticide is applied; 2) in the area of the field study. Halls Bayou was surrounded by rice
fields; and 3)galls 'Bayou isa" relatively"small" w"a|e^^y "With" "little flow or tidal flushing,
resulting in little dilution of water draining from rice fields.
The aquatic residues measured at other times during the Halls Bayou study, as well
as those measured in a drainage ditch in the biological field study conducted near
Matagorda, Texas [see section C.l.b(7)], provide examples of situations that would result
in exposures that are moderately high, put more typical. Other than the concentrations
measured after the intense rainfall event of the 19th of April, the greatest thiobencarb
concentrations were measured in samples taken on 7 April following several planned
flushes in the region during the previous week. Samples taken that day at two sites in the
Bayou near the point of discharge of water draining from the rice fields were 83 and 64
ppb. Measured residues were 40 and 48 ppb in two samples taken on 6 April, and 33 ppb
in a sample taken on 8 April. Residues remained at a concentration of 10 ppb or greater
through April 12, when sampling was ceased.
Aquatic residues measured in the study near Matagorda study were less than those
measured at Halls Bayou. The greatest measured residues (average of two replicate
samples) was 20 ppb in I983""and"21'ppb in 1984. Residues were commonly between 1
and 15 ppb for a few days following applications of thiobencarb aid/or flushing of fields.
73
-------
regions. Unlike in California, thiobencarb is primarily applied to water-seeded rice in
these regions by applying a liquid to soil before the fields are flooded. This use is similar
to dry-seeded rice in terms of expected environmental exposure. Therefore, the
concentrations measured for dry-seeded rice in the biological field studies was also used
to represent exposures from water-seeded rice in the southeastern regions.
Water-seeded Rice in California
The Agency used surface water monitoring data to approximate the concentration
of thiobencarb likely to be found in water in areas of'California where water-seeded rice
is grown. Two recent sources of data on thiobencarb were available. One was a US
Geological Survey Open-file Report on the monitoring of dissolved pesticide
concentrations in the San Joaquin River and Sacramento River in 1991 through 1993
(MacCoy et al., 1995). The other source of data, was monitoring of thiobencarb
concentrations in waterways that drain rice growing areas in the Sacramento River Valley.
This data was submitted to the EPA by Valent U.S.A. Corporation under the 6(a)(2)
provisions of FIFRA.
Approximately three years of routine water monitoring of the San Joaquin River
at VernaliSj California and of the Sacramento River at Sacramento, California (MacCoy
et al., 1995) found that thiobencarb concentrations were always low, below 0.05 ppb. For
most of the sampling period, thiobencarb residues were not detected or were below 0.025
ppb. The only exception was a 10-12 period during May and June of 1993 when
measured residues, generally were greater than 0.1 ppb. Peak residues were 0.53 ppb in
the San Juaquin River and 0.70 ppb in the Sacramento River.
/
Monitoring conducted by the California Environmental Protection Agency and
submitted by the Valent U.S.A. Company found that levels of thiobencarb in some of the
waterways draining into the Sacramento River were occasionally greater than in the river
itself. Concentrations were always below 1 ppb in the Butte Slough, but frequently
greater than 1 ppb in the Colusa Basin Drain (Table 34). A peak concentration of 37 ppb
was recorded in the Colusa Basin Drain.
Table 34. Thiobencarb concentrations measured in waterways flowing into the Sacramento River,
California '
Date Sampled
5-3-94
5-5-94
5-9-94
5-12-94
5-16-94
Water Sampling Locations
CBD1
,_
r-
0.212
CBD5
, not detected
0.18
0.49
0.42
37.4
SSI
,
'
0.34
BS1
o.io :
0.09
0.06
0.07
0.11
75
-------
Date Sampled
5-19-94
5-22-94
5-26-94
5-30-94
6-2-94
$$$4 '."".'
-94
6:13,-94 ..
6-16-94
6-20-94
6-23-94
6-27-94
4:30-94 ,
7-4-94
7-7-94
Water Sampling Locations
CBD1
0.103
3.34
0.8
0.46
0.28
0.58
15.8
6,2
4-74
-
CBD5
0.768
',. ,:,/^0^,r" "..,..:
;': ; ; 0.9*92
0.66
4
0.5
0.38
0.34
0.284
0.42
0.11
0.51
0.63
0.28
0.21
SSI
0.40
0.26
0.19
0.12
nd
0.10
0.08
0.08
0.10 .
i" '
/
BS1
0.09
0.08
0.11
0.18
0.12
nd
0.10
nd
0.08
nd
0.53
nd
nd
0.12
0.18
(nd ป not detected)
Vegetables in Southern Florida
Very limited information, is available on thiobencarb concentrations in southern
Florida. The National Water Quality Assessment Program (NAWQA), being conducted
by the US Geological Survey, is currently collecting water samples in southern Florida
and analyzing them for pesticides, including thiobencarb. One sampling station is located
in an area that is drained by agricultural land in Palm Beach County where most of the
Florida use of thiobencarb is located. This Station is on the HUlsborro canal along the
southern border of the Loxahatchee National Wildlife Refuge, and thus would provide
indication if thiobencarb is entering this important wetland habitat.
To date, testing for thiobencarb has only been completed for approximately 16
Samples that were taken in the fall of 1996 into the winter of 1997. Thiobencarb was not
detected in these samples. The minimum detection level of thiobencarb is 0.002 /^g/L.
However, it is premature to draw any conclusions from these data. For one thing, these
data do not yet include sampling for the spring, the time when most applications of
thiobencarb are made. Interpretation of the NAWQA monitoring data should be postponed
until the collection, quality control, and analysis of the data have been completed.
76
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(c) Freshwater Fish
The risk of acute effects to freshwater fish from the use of thiobencarb on rice is
uncertain. The maximum residue measured in Halls Bayou when heavy rainfall occurred
on the day .of application was 690 ppb. This exceeded the lowest LC50 determined for
freshwater fish, 560 ppb for the bluegill sunfish, indicating a high risk to freshwater fish.
This conclusion is supported by a fish killed observed in the Matagorda study which was
attributable to thiobencarb exposure. Several other supplemental studies, however, found
that the LC50 for various freshwater fish is greater, in the range of 1.1 to 2.8 ppm. Based
on these supplemental data, the acute risk of thiobencarb would be minimum to low.
Furthermore, other aquatic residues measured in the Halls Bayou, as well as all of those
measured in the Matagorda study, were well below even the lowest LG50 of 560 ppb.
Therefore, the acute risk of thiobencarb to fish is uncertain. If there is an acute risk, it
apparently would be limited to high exposure situations in,which heavy rainfall occurs
soon after application discharges contaminated water into a small water body where it
would not be greatly diluted.
Measured aquatic residues from monitoring in California were no greater than 37
ppb. As this is well below levels that are expected to cause acute effects, use of
thiobencarb on rice in California is expected to pose minimal acute risk to freshwater fish.
No acute effects on threatened and endangered species are expected.
For other uses of thiobencarb, acute risk quotients for freshwater fish are given
Table 35. .
Use Site
Celery (FL)
Lettuce and endive (FL)
Use Rate (LB/ A)
8
6
kC5fr (ppb)
560
560
EEC Initial
-------
The maximum residue measured in Halls Bayou after a heavy rainfall was 690 ppb,
which was 6.9 times greater than the acute EC50 for Daphnia magna, 100 ppb. Residues
measured in Halls Bayou on another day that was not associated with a heavy rainfall
event wife 83 and 6,4 ppb. Risk quotients calculated based on these values are 0.83 and
0.64, respectively, which are greater than the. LOG for presumption of high risk, 0.5.
Aquatic residues measured in the Matagorda study were less and do not indicate a high
risk to acute aquatic invertebrates. These results indicate that the risk to freshwater
invertebrates posed by use of thiobencarb on rice in the southeastern regions range from
low to high, depending;_on the^wea&er^andloc^ conditions.^ High risk probably is limited
to aqualc habitats near the"discharge of taiiwater and during times when heavy rainfall
occurs soon after thiobencarb is applied.
Measured aquatic residues from monitoring in California were no greater than 37
ppb. An acute risk quotient based on this value is 0.37, which is less than the LOG of
0.5. Therefore, use of thiobencarb on rice in California is expected to pose minimal acute
nsjcto ||esJMa|$r inyerjg^ for freshwater invertebrates,
in general, there is still a concern for threatened and endangered species.
Based on a chronic toxicity study with the Daphnia magna, thiobencarb is
predicted to cause chronic effects in freshwater invertebrates when concentrations remain
near or above 1 to 2 ppb for an extended period of days. Aquatic residues measured
during the two biological field studies indicate that this condition will commonly occur in
areasWhere.iMobencarbjs^applied. For example, of the 24 samples analyzed from Area
II of Halls Bayou between 24 March and 30 April, all but two had thiobencarb
concentrations greater than 2 ppb. Even in the Matagorda study, where residues were
generally lower, measured residues equal or exceeded 1 ppb for 9 consecutive days in
1983 and 7 consecutive days in 1984. During periods of peak exposure, residues were 12
to 406 times greater than the MATC for Daphnia magna. These findings indicate that use
of thiobencarb on riceJin the southeast regions poses a definite high risk of causing chronic
effects to freshwater invertebrates. Adverse effects to freshwater invertebrates are
expected to occur frequently.
Use of thiobencarb on water-seeded rice in California is predicted to pose less of
a chronic risk to aquatic invertebrates than in the southern rice-growing regions. Water
sampling from the Sacramento River and San Juaquin River show that thiobencarb
concentrations never exceeded 1 ppb, the NOEC for Daphnia magna. The majority of
readings were less than 0.05 ppb. In contrast, concentrations in smaller waterways
c
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For uses other than rice, acute and chronic risk quotients for freshwater
invertebrates are given below.
Table 36. Risk Quotients (RQs) for Freshwater Invertebrates Based on a Daphnid ECSO and a
Daphnid MATC
Use Site
Celery (FL)
Lettuce and endive (FL)
LC50
(ppb}
100
100
MAJC
(Ppb)
1.7
1.7
EEC Initial
(ppb)
186
140
EEC 21-Day
(ppb)
173
130 .
Acute RQ
(EEC/LCyo)
1.86
1.40
Chronic RQ
I CEEC/MATC)
101.76
76.47
Acute and chronic risk quotients, exceed the LOG for high risk. These results
indicate that use of thiobencarb on vegetables in Florida, at the maximum label rate, poses
a risk to freshwater invertebrates due to both acute and chronic effects. Because the
chronic risk quotients are extremely high, chronic effects on invertebrates are expected to
be severe. , .
(e) Estuarine and Marine Animals
Based on aquatic residues measured in the biological field study at Halls Bayou,
use of thiobencarb on dry-seeded rice can result in concentrations of thiobencarb of 690
ppb. This represents a near worst-case scenario when heavy rainfall occurs immediately
after thiobencarb is applied. Concentrations this great would exceed the acute LC50 for
the mysid (150 ppb) and eastern oyster (320 ppb), and would be close to the LC50 for the
sheepshead minnow (660 ppb). They would also approach or exceed the LC50 values that
Borthwick et al. (1985) reported for the Atlantic silverside, tidewater silverside, and
California grunion. These findings indicate that the use of thiobencarb on rice in the
southeast regions poses a high acute risk to estuarine fish, crustaceans (including shrimp),
and mollusks at times of high exposure resulting from heavy rainfall occurring soon after
.application.
Other than the one measurement of 690 ppb, however, concentrations in Halls
Bayou were not greater than 83 ppb. Furthermore, two years of sampling in the
biological field study near Matagorda found that residues reached a maximum of 21 ppb.
Using the exposure value of 83 ppb, the risk quotients for fish, mollusks, and shrimp are
0.13, 0.26, and 0.55, respectively. This indicates that, under conditions other than those
described above, the acute risk is minimal to fish and mollusks. The RQ still exceeds the
LOG, however, for high risk for shrimp and other crustaceans.
The measured concentration of 690 ppb, representing a high exposure associated
with heavy rainfall, indicates a high chronic risk to fish and crustaceans. In addition, a
high chronic risk to crustaceans exists even for exposures measured not associated with
heavy rainfall. The MATC from chronic, studies with,crustaceans found MATCs that
ranged from 4.5 to 35 ppb. Water concentrations measured near Matagorda exceed the
lower bound of this range,' and those'measured at Halls Bayou exceed even the upper
79
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bound of this range. The lower end of the .range was sometimes exceeded for several
consecutive, days in both of the biological field studies (for example, 8 days in Area II of
:,H,al|s,, ;B;aypu, 4 davsn_ at Station^ 1 on the_ canal in the Matagorda study in 1984). It is
therefore clear that use of thiobencarb on rice in the southeastern regions poses a high
chronic risk to shrimp and other aquatic crustaceans.
Chronic risk to fish is less certain. A test concentration of150 ppb caused reduced
growth in the sheepshead minnow. High exposures of thiobencarb, such as the 690 ppb
measured at Halls Bayou, will exceed this level, but probably for only short periods of
time, Monitoring data show that peaks in aquatic residues usually last for only a day or
two (Fig. 1). Under typical conditions, maximum exposures would be considerably less
than l5Gppb. For water^seeded.rice, thipbencarb concentrations are expected to exceed
150 ppb in the field, but it is not known if they would exceed 150 ppb in off-site aquatic
habitats 5 The available data thus indicate that thiobencarb has the potential to cause
chronic effects on estuarine fish in the southern growing region. However, the level of
this risk is highly uncertain because a chronic NOEC has not been determined.
In California, the only estuarine habitats that are likely to be exposed to significant
residues of thiobencarb are bays near San Francisco that receive water from the
Sacramento River and San Juaquin River. All of the rice-growing region in California is
drained by these two rivers. Stringent regulation requiring the retainment of floodwater
from rice fields have greatly reduced concentrations of thiobencarb occurring in the
Sacramento-San Joaquin Delta since 1985 (Bailey, 1993). Monitoring data show that
between 1991 and 1993 thiobencarb concentrations in these rivers are always less than 1
ppb, and are usually below 0.1 ppb (MacCoy et al., 1995). This level of exposure would
not be expected to cause any significant acute or chronic effects to any estuarine fish or
invertebrate. Because concentrations in the bays would be no greater than concentrations
in the rivers that feed them, the risk assessment indicates that use of thiobencarb on rice
in California poses minimal acute and chronic risk to marine/estuarine fish and
invertebrates (including shrimp and mollusks). For uses other than rice, the acute and
chronic risk quotients for three estuarine and marine organisms are given below.
Table 37.
MATC
Risk Quotients (RQs) for Freshwater Fish Based on a Daphnid ECSO and a Daphnid
Use Site
I
Celery
(PL)
Lettuce and
endive
ป . .:;,
Test organism
Sheepshead minnow
Eastern oyster
Mysid
Sheepshead minnow
Eastern oyster
Mysid
LC5&
(Ppb)
660
320
150
660
320
150
MAtC
(ppb)
<150
ND
4.5 - 35
<150
ND
4.5 - 35
EEC Initial
(ppb)
186
186
186
140
140
140
21 -or 56-Day
EEG (ppb)
157
113 . ,
173
118
130
130
Acute RQ
(EEC/LCJO)
0.28
0.58
1.24
0.21
0.44
0.93
Chronic RQ
(EEC/MATC)
>1.04
4.9-38
>0.79
3.7-29
fdfish.
EEC is used for assessing risk to aquatic invertebrates whereas the 56-day EEC is used for assessing risk
80
iiiiiiiiijiiiiiiiii ..... iiiiiiiiiiiiiiit/jijii:.:!.,
i, ....... iBiiiij'jiii: iiiiiii ....... is
,: iiJiM^^^ flii'.iiH ;
-------
These results indicate that use of thiobencarb on vegetables in Florida, at the
maximum label rate, poses a high acute risk to marine/estuarine oysters, shrimp, and other
aquatic invertebrates. The RQ for chronic effects to shrimp and other marine/estuarine
invertebrates is imprecise because only supplemental data are available. Nevertheless,
based on the range of findings from the four available supplemental studies, it is clear that
the RQ for these organisms is well above the LOG of 1, signifying a high chronic risk.
The acute RQ for marine estuarine fish in Florida is less than the LOG of 0.5,
indicating the acute risk is not high, but it is greater than the LOG of 0.1., indicating that
restricted use may be applied. This risk quotient also indicated that threatened and
endangered species of fish may be adversely affected.
Definitive chronic RQs could not be determined for marine/estuarine fish because
the only available chronic fish study failed to determine an NOEC. However, since,
adverse effects were observed at a test concentration of 150 ppb, it is certain that both the
NOEC and MATC would have been less than this value if lower concentrations .were
tested. The chronic fish RQ may therefore be expressed as a "greater than" value. At the
rate of 8 Ib/A, the maximum use rate for celery, the RQ is greater than 1.0, signifying a
high chronic risk. At the rate of 6 Ib/A, the maximum use rate for lettuce and endive, the
RQ is greater than 0.79. Since this value is not much less than the LOG of 1, use at this
rate may also pose a high chronic risk to fish. These findings thus indicate that the use
of thiobencarb on vegetables in Florida may pose a high chronic risk to fish. An
additional fish life-cycle study (GDLN 72-5) is needed to confirm this risk.
(4) Exposure and Risk to Nontarget Plants
(a) Terrestrial and Semi-aquatic
The Agency does separate risk assessments for two categories of nontarget plants,
terrestrial and semi-aquatic. Non-target terrestrial plants inhabit non-aquatic areas which
are generally well drained. Non-target semi-aquatic plants inhabit low-lying areas that are
usually wet, although they may be dry during certain times of the year. Both the
terrestrial and semi-aquatic plants are exposed to pesticides from runoff, drift, and
volatilization. They differ, however, in that terrestrial plants are assumed to be subjected
to sheet runoff, whereas semi-aquatic plants are assumed to be subjected to channelized
runoff. ..-
The Agency assumes .that runoff will expose nontarget plants to a fixed percentage
of the application rate. This percentage is estimated based on the water solubility of the
active ingredient:
Water Solubility
< lOppm
10 - 100 ppm
% Runoff Assumed
1%
2%
81
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> 100 ppm
5%
Since the water solubility of thiobencarb at 20ฐCis 27.5 ppm, the percent runoff
is assumed to be 2%. For non-target terrestrial plants, The Agency assumes a scenario
in which plants are exposed from sheet runoff. A treated site of 1 acre is assumed to drain
into an adjacent area of 1 acre where terrestrial plants may be impacted. In the scenario
used for non-target semi-aquatic plants, exposure from runoff is assumed to be from
channelized runoff. A tteated site of 10 acres is assumed to drain into a distant low-lying
area of 1 acre where semi-aquatic plants may be impacted.
Exposure from spray drift was also assumed to be a fixed percentage of the
appEcafion rate. Spray drift exposure is assumed to be 1 % and 5 % of the application rate
for ground and aerial applications, respectively.
Formulae for Calculating EECs
Terrestrial plants inhabiting areas adjacent to treatment sites
Unincorporated ground application:
gjinoff Loading = maximum application rate (Ibs ai/acre) x runoff value
Drift Loading = maximum application rate x 6.01
Total Loading = runoff (Ib ai/acre) + drift (Ib ai/acre)
Aerial applications:
Runoff Loading = maximum application rate (Ibs ai/acre) x 0.6 (assumed application efficiency)
x runoff value
Drift = maximum application rate (Ibs ai/acre) x 0.05
Total Loading = runoff (Ib ai/acre) + drift (Ib ai/acre)
Semi-aquatic plants inhabiting wet low-lying areas
i
Unincorporated ground application:
Runoff Loading = maximum application rate (Ibs ai/acre) x runoff value x 10 acres
Drift Loading = maximum application rate x 0.01
Total Loading = runoff (Ib ai/acre) 4- drift (Ib ai/acre)
:, ' ' " " " I I I I I II I I ' . '',..';
Aerial applications:
Runoff = maximum application rate (Ibs ai/acre) x 0.6 (60% application efficiency assumed) x
runoff value x 10 acres
Drift = maximum application rate (Ibs ai/acre) x 0.05
Total Loading = runoff (Ib ai/acre) + drift (Ib ai/acre)
Use of thiobencarb on rice is not expected to result in significant exposure to
nontarget terrestrial and semiaquatic plants from runoff. Rice fields are always bordered
by a dike or temporary berm which would prevent runoff from leaving the field. These
structures do have a gate or opening for the release of water from the field, but this-water
is normally channeled into a stream or river. Outflow from rice fields will therefore not
82
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normally enter dry-land and wetland habitats where terrestrial and semiaquatic plants
occur, respectively.
f . i
Nontarget plants also may be exposed from spray drift. The Agency calculated
risk quotients by dividing the EECs by the vegetative vigor EC25 for the most sensitive of
the test species. Spray drift, and thus exposure to nontarget plants, will be negligible
when thiobencarb is applied as a granule. The, Agency assumes that spray drift from
liquid (EC) formulations of thiobencarb results in EECs that are 5% and 1% of the
application rate for aerial and ground applications, respectively! When applied at the
maximum label rate of 4 Ib/A, the EECs for nontarget plants are thus 0.2 Ib/A for aerial
applications and 0.04 Ib/A for ground applications. The EC^ for vegetative vigor of the
. . most sensitive test species, ryegrass, is 0.073 Ib/A. The risk quotients are 2.7 for drift
from aerial applications and 0.55 for drift from ground applications. These results
indicate that spray drift from aerial liquid application of thiobencarb to rice poses a high
riskto nontarget plants. Risk to nontarget plants is minimal from all ground applications
and aerial applications of granules to rice.
For uses other than rice, exposure to nontarget terrestrial and semiaquatic plants
has a runoff component as well as a spray drift component. Only ground applications are
permitted for these uses. Estimated environmental concentrations for terrestrial and semi-
aquatic plants are given below.
Table 38. Estimated Environmental Concentrations (EECs) For Terrestrial and Semi-Aquatic
Plants
Use Site '
Celery (FL)
Lettuce and
endive (FL)
UiSe Rate
ObaS/A)
8
6
Riiaoff
Value
0.02
0.02
Runoff Loading
Sheet Runoff
(Ibai/A)
0.16
0.12
Channelised
Runoff (Jbai/A)
1.60
1.20
Spray Drift
Loading
-------
lillFininil in ill!!'llimi l.j MUW!TSIWS
-------
from the Sacramento River and San Juaquin River show that thiobencarb concentrations
never exceeded 1 ppb. Thiobencarb concentrations in these rivers are not expected to
approach levels toxic to algae. In contrast, concentrations measured in smaller waterways
that feed into the Sacramento River occasionally approached or exceeded the algae EEC
of 17 ppb (Table B). These results indicate that the use of thiobencarb in California poses
some risk of affecting algae in the smaller waterways, but minimal risk to algae in the
larger.rivers. . - .
The EC50 for duckweed is 770 ppb. This indicates that the toxicity of thiobencarb
to vascular aquatic plants is low relative to the aquatic EECs for rice. However, the
Agency believes that the phytotoxic'ity test with duckweed poorly represents the toxicity
of thiobencarb to many aquatic vascular plants. The seedling emergence, studies indicate
that grasses are highly sensitive to thiobencarb. Duckweed is not a good surrogate for
aquatic grasses and sedges. Duckweed is a dicot with primitive vascular structure,
whereas aquatic grasses and sedges are monocots with advanced vascular structure.
Furthermore, the primary phytotoxic effect of thiobencarb is inhibiting shoot growth of
immature plants. The aquatic plant test with duckweed does not address toxicity through
this mode of action. The Agency was unable to perform a reliable risk assessment for the
effects on emerging vascular aquatic plants. However, since thiobencarb is used to control
the growth of aquatic weeds in rice fields, the Agency assumes that thiobencarb residues
discharged into aquatic habitats poses a risk of. killing emerging seedlings of vascular
aquatic plants that are sensitive to thiobencarb. The risk appears to be greatest to aquatic
grasses. Risk to mature aquatic vascular plants is predicted to be minimal. '
For other uses of thiobencarb, risk quotients for-aquatic plants are given below.
Table 40. Risk Quotients (RQs) for Aquatic Plants Based on a the EGSO of Green Algae
(Selenastrum capricornutum)
Use Sit&
Celery (FL)
Lettuce and endive (FL)
Use Kate (LB/A)
f8
6
Test Species
Green algae
Green algae
; BCift(ppb)
. 17
17
EEC (ppb)
186
140
RQ (EEC/EC50)
10.9
8.2
These results indicate that use of thiobencarb on vegetables in Florida at the
maximum label rate poses a high risk to nonvascular aquatic plants. As with use on rice,
the Agency assumes that thiobencarb residues that may reach aquatic habitats by drift and
runoff pose a risk of killing emerging seedlings of vascular, aquatic plants that are sensitive
to, thiobencarb.
(5) Endangered Species
The above risk assessment indicates that use of thiobencarb on rice poses a risk to-
threatened and endangered species (TES) of birds, mammals, fish, and aquatic
invertebrates (including crustaceans and mollusks). The greatest risk is from chronic
effects, although some risk of acute effects exists for all of these animals except birds.
85
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Use of thiobencarb on rice also poses a risk to T & E Species of plants. All types of
applications, may harm aquatic plants, whereas only aerial applications of liquid
formulations are expected to harm terrestrial and semiaquatic plants when thiobencarb is
used according to label directions.
Use of thiobencarb on lettuce, endive, and celery in Florida may harm all types of
threaten^(ipriendanjer^ispecies (birds,/mammals, fish, aquatic invertebrates, and all
types 6f plants). 'in'IPSf.'the'USFWiS declared jeopardy from use on Florida vegetables
to the Snail Kite, but not to the Wood Stork or Bald Eagle; the jeopardy opinion for the
Snail Kite was reversed to non-jeopardy in 1987 after additional data were available.
In 1988, the USFWS determined that use of thiobencarb on rice in Arkansas may
jeopardize the fat pocket pearly mussel (Potamilus capax}. The current label for Bolero
SEC contains use prohibitions to protect this species. These use prohibitions apply to the
Arkansas counties of Mississippi, Poinsett, Cross, St. Francis and Lee where the Fat
Pocketbook Mussel is known to occur. Comparable warnings would be appropriate where
Use on Hce can expose other threatened 'and endangered'mussels. In 1987, the USFWS
determined that, because thiobencarb is not as toxic to the apple snail as to other aquatic
invertebrates, it is not expected to jeopardize the Everglades kite.
The Endangered Species Protection Program currently includes use limitations to
protect mussels associated with certain rice areas. In some cases, (e.g., Arkansas), label
requirements exist; in other areas, voluntary use limitations are being expressed in county
bulletins being distributed to pesticide users until the program becomes final. California
and Florida have state-initiated plans that would be expected to protect any listed species
in those states. Additional use Imitations for other species and areas are expected, but
these have not yet been defined and may be formulation specific. Some use limitations
could be 2evelbped by "lie Agency, but additional consultations with the USFWS may be
necessary. Registrants will be informed if any label changes are necessary.
4. Risk Characterization
a.
Extent of Use
The Biological and Economical Assessment Division estimates that approximately
1,190,000 Ib of thiobencarb active ingredient are applied on rice annually. Use on rice
is divided into three general areas: the Gulf Coast (Texas and Louisiana), the Mississippi
River Valley (Arkansas, Mississippi, Louisiana, and Missouri) and the Sacramento and
San Joaquin River Valleys in California. A small amount of rice is also grown in Palm
Beach and Hendry Counties, Florida.
A much smaller use of thiobencarb is on celery, lettuce, and endive in Florida.
The estimatedannual use of thiobencaib on these crops is approximately 30,000 Ib ai. The
majority of these crops are grown in Palm Beach County.
- ' -' ''""<:'"''" ' ';.-.^"i- 86 ;;''""":"' '::'' ''':
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b. Summary of Risk Assessment
, i _ ''.'..
Thiobencarb poses a risk not only to nontarget plants (as do most herbicides) but
also potentially significant risk to many aquatic habitats and terrestrial wildlife. The
ecological risks of the various uses are summarized below.
Use of liquid formulations pose some acute risk to mammals. The acute risk to
birds is minimal.
Use of liquid formulations pose a high chronic risk to birds and mammals. The
chronic risk from granular formulations could not be assessed.
Use of tbiobencarb on rice in the southeast US poses a high risk of chronic effects
to freshwater and estuarine aquatic invertebrates, including shrimp and mollusks.
There is also likely a high risk of chronic effects to fish, but additional data are
needed to confirm this. This use of thiobencarb also poses a high risk of acute
effects to fish and aquatic invertebrates in certain high-exposure situations.
Use of thiobencarb on rice in California poses a risk of causing chronic effects to
aquatic organisms in the smaller drains and waterways, but not in the larger rivers.
Its use poses minimal risk of acute effects to fish and aquatic invertebrates
Minimal risk of both acute and chronic effects is expected for all estuarine
organisms in California.
Spray drift from aerial application of liquid thiobencarb on rice poses a high risk
to nontarget terrestrial and semiaquatic plants. Drift of granular thiobencarb and
- spraying of liquid thiobencarb applied with ground equipment pose minimal risk
to these plants.
All uses of thiobencarb on rice may pose a risk of killing emerging seedlings of
aquatic plants, especially aquatic grasses. Use of thiobencarb on rice may pose a
risk to aquatic algae in the southeast US and in smaller drains and waterways in
California.
Use of thiobencarb on celery, lettuce, and endive in Florida poses a high risk of
causing chronic effects to fish, freshwater invertebrates, and estuarine
invertebrates, including shrimp. Additionally, this use poses a high risk of
causing acute effects to freshwater and estuarine invertebrates, including oysters
and shrimp.
Use of thiobencarb on celery, lettuce, and endive in Florida poses a high risk to
terrestrial plants, semiaquatic plants, and algae. It may also pose a risk to
emerging seedlings of vascular aquatic plants. , . .
87 "
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c. Impacts to Water Resources
(1) Ground Water
Although thiobencarb does exceed several of the criteria for the proposed ground
water restricted use rule, the Agency does not consider thiobencarb to be a candidate for
restrictelluse due to ground water concerns. The Agency does not consider use of
th|obencarb to be a concern in ground water, nor a human health concern from residues
in drinldng wafer that are derived from ground water.
(2) Surface Water
Detectionsi of^ thiobencarb in water samples were relatively rare in the STORET
database of the Office of Water, EPA. Thirty-nine positive detections were reported for
3,130 samples, with a maximum concentration of 0.24 mg/L and a mean concentration of
0.10 mg/L. Surface water concentrations measured in biological field studies were several
orders of magnitude g^j^f than this. The field study measurements were taken in surface
water that was"11]uaame(!kMy~adja<^i^'to rice fields and were taken soon after thiobencarb
was applied. This suggests that high levels of contamination of thiobencarb in surface
water is limited to local areas and for brief time periods.
Ulilike the fltered sample 'results" reportedin STORET, results reported in the
biological field studies may have been from uriiiltered samples. As thiobencarb tends to
partition more into sediment than water, the presence of suspended sediment in the water
samples may have contributed to higher concentrations being reported in the field studies
than in the STORET database.
Aquatic EEC mDeling for lettuce, endive and celery uses estimated relatively high
levels of contamination in surface water. The range of aquatic EECs was 140 mg/L for
the 6 Ib a.i. application rate and 180 mg/L for the 8 Ib a.i. application rate. Thiobencarb
is expected to 'dissipate in pb"ii3!"water at an approximate rate of 0.4-0.6 mg/L/day.
d. Environmental Fate and Risk Characterization
(1) Rice in Southeastern United States
iii"1 ' III * II i1
(a) Terrestrial Ecosystems
The main risk from tMobencarb to terrestrial vertebrates (birds, mammals, reptiles,
and terrestrial stages of ampnlbians7) is from reproductive and chronic pathological effects.
1 No data were available for reptiles or amphibians; therefore, risk to these organisms is inferred from the assessment
of risk to birds and mammals.
-------
The risk assessment for mammals determined that there is also a risk of acute mortality
from all uses of thiobencarb. However, maximum acute RQs for mammals range from
less than approximately 0.5 for use on rice to slightly greater than 1 for use on celery.
These RQs are much smaller than those for risk of chronic effects to these organisms. In
general, the impact to terrestrial ecosystems from acute effects is expected to be of little
significance, whereas the impact from chronic effects is considered to be of greater
significance.
Use of thiobencarb in the southeast is expected to harm terrestrial vertebrates by
causing chronic physiological effects and, in the case of birds, impairing reproduction.
The levels that cause chronically toxic effects in both birds and mammals were quite low
for a pesticide that is used at high rates (4 to 8 Ib ai/A). Furthermore, thiobencarb does
not degrade rapidly in the terrestrial environment. The combination of these factors result
in EECs remaining at levels that may cause chronic effects for several weeks (Tables B and
C). While reproductive and other sublethal effects may result from short-term exposures
(one week or less), there is higher certainty that these longer-term exposures will cause
these effects. Also, the longer exposure in the environment allows greater opportunity for
more organisms to be exposed.
The Biological and Economic Analysis Division (BEAD) estimates the typical use
rate of thiobencarb on rice is 3 Ib ai/A. Compared to the maximum label rate, use at this
rate would decrease exposure levels, and thus the risk quotients, by 25%. Chronic risk
quotients for birds and mammals would still be great enough to indicate a high chronic
risk. .
The timing of application of thiobencarb on rice in the southeast region is from
March through June. This corresponds with the breeding season of birds and mammals.
Avian reproduction studies have shown that thiobencarb may decrease the number of eggs
laid or chicks hatched at dietary concentrations that are similar to environmental
concentrations expected in some wildlife food. It thus appears likely reproduction could
be impaired in birds that feed in rice fields that have been sprayed with thiobencarb.
For the reasons" stated above, the chronic risk to terrestrial organisms is
characterized as "high".. It is not characterized as "very high" because thiobencarb is only
moderately persistent in terrestrial environments and its bioaccumulation is only moderate.
Also, except for flooded fields in Louisiana, the use of rice fields by wildlife is not
expected to be great during the spring in the Southeast (Gusey and Maturgo, 1973):
Another threat to terrestrial ecosystems in the southeast region is the potential harm
to nontarget plants. In this area, thiobencarb is usually applied in a liquid EC formulation
which may be sprayed from either aerial or ground equipment. Spray drift from aerial
applications are predicted to pose a high risk to some nontarget terrestrial and semiaquatic
plants. This may degrade the quality of habitat close to rice fields. This risk may be
minimized by applying thiobencarb with ground equipment. "
. > 89
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^
*!""'
(b) Aquatic Ecosystems
1
Acute Risk to Pish and Invertebrates
Rice is grown along the Gulf coasts of Texas, Mississippi, and Alabama, often in
areas extending many miles inland, as well as in Palm Beach and Hendry counties in
Florida. Data from the U.S. NationalCHmatolpgical Data Center (USNCDC) indicates
that rainfall in this area is typically around 60 inches per year and that storms of three
inches or more occur about once per month. The rice farmer cannot always retain this
.vqlumijjf,,Fa|eฃos;the paddy8. Therefore farmers might apply thiobencarb one day and
be forced to releasejtthrough the drain gate the next due to unforeseen heavy rains.
Discharges from rice fields following heavy rain events are expected to result in
several hundred parts per billion of thiobencarb for short durations in some small estuaries
and streams. Mpnitgring data is available (Section C.l.b.7) showing that these discharges
can raise water concentrations in.biologically productive estuaries to levels exceeding the
<*iM^.'sl2r ^ and a(luatic invertebrates. In general, the Agency would expect fish Mils
arid invertebrate Mils due to acute exposure to be localized and to be confined to bodies
of water near rice fields that have little flow or tidal flushing.9 During the Matagorda
study, there was a fish Mil involving menhaden in such an area. The flesh residues of
thiobeuearb in these fish indicate that thiobencarb may have caused the Mil. However,
since other pesticides were being used in the area, it is not certain that thiobencarb was the
?ฐle cauงe, The Agency Miows of no other fish Mils that have been linked to thiobencarb.
There is no evidence to suggest that acute risk to fish is a major, widespread problem.
;<:' Mi SOU ,!' ' ''. :' M.'1,,:(.)".!!! *. I]1'1* I:'1'. IK SiJirSi1""-1!,!1"! ;!'ซ' i:,:. , u", *'Jt,l'iซ: iSClDL,1!1! MK.**ri<'.M '..>' ','1 '.< : '
The acute toxicity of thiobencarb to aquatic invertebrates is about the same as that
for fish. Some .acute mortality of crustaceansandoyster larvae may occur in localized
.^areas neari rice'.fields where high levels of contamination may occur after heavy rainfall.
Tn? to:^ityio ฐ*er invertebratessuch as corals and jellyfishes (phylum: coelenterata),
rotifers (phylum: rotifera; protozoan like organisms which are abundant in freshwater) has
not been determined.
The ric* plant is particularly sensitive to flooding when, the stem is long and thin soon after germination. At that
time the farmer would try to maintain the water level between. 4 to 8 inches. (Personal comm., Dr. Steve Linscombe
LSTJ). :' '
In the
Grulf Coast, % difference between high iand low tides is only about two feet, which is quite small compared to California
or the Northeastern ..... Coast. ,, ............................ ....... i ........................ _ ............ '.,-'..
Subphylum Crustacea, which is comprised of such common animals as shrimps, amphipods (scuds), and copepods,
is the most numerous of the marine planktonic animals.
'' ..... :"::" "' " :''' ''' : '' : 90 ...........
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Rice is also grown in the Mississippi River Valley. Rainfall data from Little Rock, '
Arkansas, which is near that state's rice growing area, indicate that the rain may also be
heavy in this area; however, the rainfall patterns are somewhat more predictable than in
the Gulf area. Because unpredictable spring thunderstorms are less numerous in this
region than on the Gulf Coast (Dr. Robert Rohli, personal communications, LSU), acute
risk to aquatic life resulting from heavy rainfall events would be less here than in the Gulf
Coast area.
Chronic Risk to Fish and Invertebrates ,
Exposure to thiobencarb poses extremely high chronic risk to aquatic organisms,
especially for estuarine and freshwater crustaceans in the Gulf Coast region. As
mentioned above, heavy rains may result in thiobencarb concentrations in aquatic habitats
which greatly exceed chronic toxicity levels of Crustacea. Monitoring data from Halls
Bayou found concentrations in water at the point of inflow from ricefield drainage of
several hundred ppb. This far exceeds the EC^ for chronic effects11 of around 10 ppb for
the mysid, and the chronic MATC for the opossum shrimp of 4.5 ppb. High levels are
expected to persist long enough in some areas to cause chronic effects. Clearly, the
chronic risk to shrimp and other crustaceans is very high and there is potential for high
impact on these populations (See Risk to Economically Important Organisms, below).
There are also many other types of invertebrates that are important components of the
estuarine ecosystem^ such as worms (annelids), jellyfishes, and rotifers. The chronic
toxicity of thiobencarb has not been tested in these species, but it quite possible that
thiobencarb would negatively affect their reproduction as it does, to crustaceans.
Many species of estuarine crustaceans and other invertebrates are potentially
vulnerable to the chronic toxicity of thiobencarb. For example, there are over 100 species
of shrimp alone in the Gulf. These creatures would presumably be very .vulnerable when
they are in.estuaries and bayous surrounded by rice fields. For reasons not fully
explained, young shrimp mass in the estuaries and streams of the Gulf Coast in the Spring.
This is the time when thiobencarb is being applied (see below). Also at great risk are
many other- crustacean species which are year-round residents in estuaries, including
mysids, young blue crabs, many grass shrimp (Palaemonetes sp), amphipods (scuds), and . '
isopods (saltwater species related to the garden "sow bug"), these invertebrates serve '
an important ecological role because they form a fundamental component of the food web. ." :
They are important fprage for young fish which use estuaries as feeding grounds. Fish '';.-:'
whose food web would thus be at stake include drums (e.g., redfish and croaker) and
flounder. . ' '
Thiobencarb may also harm freshwater in the Southeast. A study submitted to
fulfill a test requirement of the Health Effects Division (Guideline Number 171-4f, MRID .
The EC05 for chronic effects is the concentration that, based on effects observed in laboratory tests, is predicted
to cause a 5% reduction in the reproductive parameters in mysid. This level was estimated using nonlinear regression.
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43404003) provides information that is useful for assessing ecological impacts to these
habitats. This study measured residues of thiobencarb in natural freshwater habitats
receiving discharges from rice fields in Arkansas and Texas. In both areas, thiobencarb
was appile^ at ajppToHmaMy'ffie'maximum" laB'el'"rate 6'f"4"lb ai/A. In the Arkansas,
residue levels measured in Bayou Bartholomew remained low, less than 1 ppb. In Texas,
however, much greater residues were measured in West Bernard Creek. Residues
measured at one sample point (EB1) remained greater than 1 ppb for 30 consecutive days.
At another sample point (EB3), residues were at or greater than 4 ppb for 18 consecutive
days. The concentration profiles in West Bernard Creek were also characterized by peaks
of higher residues levels that were associated a flush and a rainfall event. During these
peaks, concentrations of 20 to 42 ppb were measured for one to three consecutive days.
As the reproduction of the waterflea, Daphnia magna, has been shown to be adversely
affected by 21-day exposures as low as 3 ppb, it is clear that the chronic risk to
invertebrates in West Bernard Creek would be high. Thus, this study corroborates our
conclusion that the use of thiobencarb on rice in the Gulf coast area poses a high risk to
freshwater invertebrates; andthef eby could "cause serious harm to freshwater ecosystems.
Risk to Economically Important Organisms
Pink shrimp (Penaeus duroaruni), brown shrimp (Penaeus aztecus), and white
shrimp (Penaeus setiferous) make up the bulk of the commercial shrimp harvest in the
United States. (These and other species in the family Penaeidae are commonly referred
to as "penaeids".) The largest harvests are of the brown shrimp. In total, hundreds of
millions of tons of shrimp are taken by U.S. ships in the Gulf of Mexico. Overall the
shrimp industry is worth billions of dollars to the economy of this country12.
,<: aill j In !': ' ; t "?; ;',. :ซ Hit" , fill- r'
Mi !ซli ii-W'f HI ill. * I W-'XXl if '> ', 'Vit'lKfSf, \ ..... ปl !:' ; i1?; ..... ISMSai '. '
The natural history of the three commercial shrimp species puts them into a
position to receive maximal concentrations of thiobencarb. They breed offshore with each
of the females shedding thousands of demersal (sinking) eggs. After hatching, the shrimp
larvae and postlarval stages are planktonic. The postlarvae utilize multiple stimuli,
including diminished salinity and variations in light, to position themselves in currents so
as to be carried into estuaries. In the estuaries they metamorphose to become benthic
(bottom dwelling) juvenile shrimp. Some young shrimp are particularly at risk because
they migrate for miles up streams that feed the estuaries, even into freshwater13. Given
that these streams would often be surrounded by rice farms, there is a great hazard to these
young shrimp.
"Rice growers typically apply thiobencarb beginning in April and ending around
June. The young sensitive stages of the commercial shrimp may be exposed to release of
, , ป 12
Economic information provided by Mr. Larry Simpson Director of the Gulf States Marine Fisheries Commission,
Ocean Springs, MS.
Information provided by Dr. T. Minello, National Marine Fisheries Service, Galveston, TX.
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thiobencarb in tailwaters, particularly around June, > when the arrival of the planktonic
larvae begins-in-the estuaries of the Gulf. The exposure of young commercial shrimp
would probably continue beyond June as thiobencarb is considered to be at least
moderately persistent in some conditions. In habitats with high turbidity or deep water,
the lack of penetration of light could make the rate of photolysis considerably slower than
was measured in the laboratory. In these environments, thiobencarb might remain
associated with sediments and organic matter on the bottom for several weeks. Being that
the juvenile shrimp are benthic, they would be exposed to these contaminated sediments.
The case regarding chronic toxicity to penaeid shrimp is considered strong.
However, there is some uncertainty in that the exposures observed in the field are of
shorter duration than those in chronic laboratory tests. Even the shortest chronic marine
crustacean tests are 28 days long. Monitoring data from all site (other than the flooded
paddies, themselves) do not show continuous aquatic residues in the range of the mysid
LCos (approximately 9 ppb) for a duration this long. On the other hand, it is impossible
to know whether the full 28 days are required for adverse effects to occur. Therefore, it
is prudent to assume, exposure to shrimp and other crustaceans represent a high risk of
chronic effects.
Risk to Aquatic Plants
The risk of thiobencarb to aquatic plants is uncertain. Although highly toxic to
nontarget plants, thiobenearb appears to act mainly through preventing seed germination
and/or early seedling growth. The reproduction of some aquatic plants, especially, annuals
that reproduce mainly through seeds, may be at risk. This may cause some damage to
vegetation growing along the edge of waterways where thiobencarb is discharged.
Thiobencarb is quite toxic to some algae including the very important green algae."
There is a high risk of thiobencarb causing some effects, but our current algae toxicity
studies cannot be used to judge whether the effects would have permanent impacts on algae
populations.
(2) Rice in California
(a) Terrestrial Ecosystems
f" ' s
In the California rice-growing region, thiobencarb is applied mainly in granular
form to flooded rice fields. This use of granular thiobencarb is not expected to pose a
significant acute risk to birds and mammals. Because of the relatively low toxicity to
mammals, the mass of granules required to equal an LD50 substantially reduces the
likelihood of significant'acute risk to mammals. For example, based on the rat oral-LD50
of 1080 mg ai/kg, a 100-g mammal has a 50% probability of being killed if it ingests
approximately 110 mg of active ingredient in one day. Since thiobencarb granules contain
10% active ingredient, this is equivalent to ingesting 1.1 g of granules in one day. This
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is much more than a mammal of that size would be expected to ingest incidentally while
foraging. Furthermore, most of the granular product would land in standing water and
thus would not be available to mammals foraging on land. There is also some use of
liquid thiobencarb in California for rice grown with pin-point flood culture. The acute
risk from this use would be similar to that for the southeastern region, that is, there would
be an acute risk to mammals but not to birds.
*
All uses of thiobencarb in California potentially pose a high risk of causing
reproductive and chronic physiological effects in terrestrial vertebrates. The
characterization of chronic risk from the use of liquid thiobencarb in California is identical
to that described above for the Southeast.: For use of granular thiobencarb on flooded rice
fields, a quantitative assessment of chronic risk could not be .performed; however, the
Agency considers that exposure of terrestrial vertebrates to granular thiobencarb poses a
Chronic risk. The numerous waterfowl and wading bird species that breed in flooded rice
fields of California14 could be adversely affected if they are exposed . The active
ingredient should rapidly dissipate from the pesticide granules once it enters a body of
water. Therefore, granules that fall in the flood water should not pose a hazard to
terrestrial organisms. However, some granuies ^Q WJQJ fall on the ground and in
vegetation on levees and around the edges of rice paddies. Birds may intentionally ingest
these granules for grit. Many birds pick up grit, which helps to grind food in the gizzard.
Birds and.other terrestrial animalsmay also ingest granules, contaminate food items, and
contaminated soil when foraging for food on the levees and field edges. Birds, mammals,
reptiles, and amphibians that live in the water would also be exposed to thiobencarb
dissQlyeJ in the: watej thrQugh dermal absorption and by drinking, although1 the
" concentrations in water are expected to be relatively low.
.'ซ;<" ! . '"' , 111 I I 111 I I I II I I Mill I .1 .ป.' ' ' ' , . ; ' , '. '
The granular formulation of thiobencarb uses a clay carrier. Best and Gionfriddo
(1994) found that house sparrow were less likely to ingest granules made of clay, corncob,
or gypsum than those made of silica. However, further studies under different conditions
Showed conflicting results. Stafford et al. (199S) found that the hazard to house sparrows
was no greater for silica granules than for clay granules. Compared to clay granules,
granules made from corncobs were found to pose less risk to house sparrows when
abundant food was provided (Stafford et. al, 1996), but greater risk when food was
restricted (Stafford and Best, 1997). The relative hazard of clay, silica, and corncob
granules is dependent on soil moisture and weather conditions, and thus cannot be
generalized. There is not sufficient evidence to conclude that the use of clay as a granular
carrier either increases or decreases the hazard of granular thiobencarb to birds compared
to if silica or corncob carriers were used.
Walerfbwl species that breed in. the California rice-growing region include the mallard, wood duck, cinnamon teal,
northern shoveler, gadwall, redhead, ruddy duck, pied-billed grebe and eared grebe. Breeding wading birds include the
great egret, snowy egret, green-backed heron, black-crowned night heron, Virginia rail, sora rail, common moorhen,
American coot, black-necked stilt, and American avocet.
-------
Avian reproductive effects observed in laboratory tests were associated with long-
term exposure to thiobencarb for approximately 20 weeks. Exposure in the wild via
ingestion of granules likely would be for a much shorter duration. Thiobencarb is applied
only once a year, and rainfall will cause the active ingredient to wash out of the granules
and cause the granules to become incorporated into the soil. These factors would cause
the exposure from granules to be relatively short-lived. Some hazard would remain from
ingestion of contaminated soil and vegetation, but these routes of exposure are likely less
important than direct ingestion of granules. It is thus uncertain if the exposure from
granular applications of thiobencarb would be long enough or great enough to cause
reproductive impairment in birds. ,
The predominance of the use of the granular formulation in California reduces the
risk of harming nontarget terrestrial and semiaquatic plants. Granules generally will fall
rapidly from the air without drifting to off-site habitats. Also, as discussed in the risk
assessment, the presence,of levees around rice fields precludes exposure from runoff into
terrestrial habitat. The Agency therefore assumes minimal exposure, and hence minimal
risk, to nontarget terrestrial and semiaquatic plants from the use of granular thiobencarb
in California. Aerial application of liquid thiobencarb on rice with pin-point flooding is
predicted to pose a high risk to these plants; however, this is currently a minor type of use
in California. . -
(b) Aquatic Ecosystems
The state of California has vast acreage of rice in the Sacramento River Basin and
some acreage in the San Joaquin River Basin. The State has imposed mandatory holding
periods before treated water from farms can be discharged. Holding periods are practical
in California because rainfall is quite low and emergency discharges of flood water are
generally unnecessary. Monitoring of California waterways indicate that water
concentrations of thiobencarb rarely reach toxic levels in agricultural drains and never
approach toxic levels in the Sacramento and San Joaquin Rivers. Therefore, the Agency
concludes that risk to aquatic habitats in California is limited to these agricultural drains
in areas with intensive rice production.
(3) Vegetables in Florida
(a) Terrestrial Ecosystems
Thiobencarb is registered for use on celery, lettuce, and endive in Florida, the
maximum use rate for these crops is 50-100% greater than that for rice. The risk posed
to terrestrial and aquatic organisms is likewise greater. Although these uses are limited
in area, the risks they pose to local terrestrial and aquatic ecosystems are extremely high.
Use of thiobencarb on lettuce, celery, and endive poses a risk of causing acute
effects to mammals.' This risk is somewhat more significant for these crops than for rice.
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11
.The riskisii(highest for use^on celery, for which the maximum EEC on food items exceeds
the estimated rat LCsq. Nevertheless, since the RQs are not very large (about 1 or less),
this risk is characterized as low to moderate.
In contrast, the risk of reproductive and chronic effects to terrestrial vertebrates
is very high. On lettuce, chronic RQs are as high as 14 for birds and 72 for mammals.
RQs are even greater for celery, as high as 19 for birds and 57 for mammals. Because
thiobencarb is moderately persistent in the terrestrial environment, the high risk from a
single ฃpp|jcatiOE fe ppg^^gjj to 'pjifsfst foj^oae to two months (Tables E and H). The
long duration of this exposure increases the certainty that chronic effects will occur, and
also provides a greater opportunity for more organisms to be exposed.
Birds, mammals, and reptiles will likely be exposed as they feed in and around
these fields, The greatest exposure would likely be to resident ducks and geese and
herbivorous small mammals. Because thiobencarb is applied during the spring, these
animals would be exposed during the time of breeding. Therefore, serious impairment of
reproduction may occur.
For the above reasons, the Agency characterizes the chronic risk to terrestrial
vertebrates frpm use of thiobencarb on celery, lettuce, and endive as very high.
se of thiobencarb on celery, lettuce, and endive is expected to result in little
exposure to nontarget plants from spray drift because aerial application is not allowed on
these crops. Nevertheless, the risk assessment indicates that spray drift from ground
applications of thiobencarb on celery at 8 Ib ai/A poses a risk of harming the vegetative
vjgpr of nontarget plants. As the RQ was very close to 1, this risk is considered to be of
minor importance.
The primary mode of action of thiobencarb in controlling weeds is killing weeds
before they emerge. Not surprisingly, then, thiobencarb poses a high risk to emerging
seedlings of nontarget plants. Unlike use on rice, use of thiobencarb on vegetable crops
in Florida may contaminate soil in off-site terrestrial habitats through runoff. Seedling
emergence" phytotbxicity studies have shown that some plants, especially grasses, are
highly sensitive to thiobencarb at the seedling stage. The primary endpoint affected
appears to be mortality of the plant rather than just reduction in growth. Furthermore, the
EECs are 5 to 44 times greater than the level predicted to kill 50% of seedlings (i.e. the
LC50) of sensitive plants. These results indicate that thiobencarb will kill most or all of
the emerging seedlings of sensitive plants exposed to levels equivalent to the EEC.
The exposure to nontarget terrestrial and semiaquatic plants is predicted to occur
more from runoff than from spray drift. The exposure from runoff may be overestimated
because thiobencarb has a high potential to bind to soil over time. The model used in the
risk assessment does not take this soil binding into account. If rainfall occurs within a day
or two after application, then exposure from runoff would be great and the high risk
' i *\I'JL\ .:.'l'.1Jii.,!M.7|1fl>t, rjii1
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predicted by the risk quotients probably would be accurate. If rainfall does not occur for
"several days, however, then much of the chemical would be bound to the soil at the -site
of application and would not be transported by runoff. The Agency still believes that a
high risk to these plants exists because the RQs are quite high and because heavy rain is
frequent and unpredictable in Florida.
The ecological impact of killing emerging seedlings of nontarget.plants is largely
unknown. Frequent exposure within a given area to a herbicide of this nature'may
potentially reduce the number of sensitive plants such as annual grasses. This may alter
the composition of the plant community, which may cause unpredictable effects on the
ecosystem.
(b) Aquatic Ecosystems
Thiobencarb is used on lettuce, endive, celery and rice in Florida. The total
acreage of these crops in Florida is probably less than 40,000 acres (1992 Census of
Agriculture). Runoff to surface water will likely cause aquatic concentrations that greatly
exceed the Levels of Concern for crustaceans and perhaps fish. Given the very small
number of acres on which this pesticide is applied in Florida, risk to aquatic organisms
should be quite localized; however, the impact to aquatic habitats within these local areas
is likely to be severe.
Most of the use of thiobencarb in Florida is concentrated in Palm Beach and
Hendry Counties. These counties lie on the northern edge of The Everglades. Water
draining from agricultural fields treated with,thiobencarb may be contributing to the
degradation of water quality of northern sections of this very important habitat, including
the Loxahatchee National Wildlife Refuge in Palm Beach County. Water" samples are
being collected along the Hillsboro canal in Palm Beach counties as part of the NAWQA
Program of the USGS. Once completed, these data should indicate the degree that
thiobencarb residues are contaminating the Loxahatchee National Wildlife Program and '
the northern everglades.
(4) Threatened and endangered species
Protecting threatened and endangered species from thiobencarb will be unusually
difficult. Adverse effects are possible for many types of plants- and animals. Probably the
greatest threat from thiobencarb is to aquatic organisms in freshwater and estuarine
habitats near areas with extensive rice production, or near large celery, lettuce and endive
farms in Florida. Thiobencarb can clearly cause, direct detrimental effects to aquatic
organisms, especially small,invertebrates. Additionally, thiobencarb may reduce the
abundance of phytoplankton and zooplankton which form the base of aquatic food webs.
This may^ cause additional indirect effects to animals at higher trophic levels. It is .
therefore important that thiobencarb be prevented from contaminating occupied habitats
of threatened and endangered aquatic species. Finally, extreme care should be taken to
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prevent contamination of the habitat of threatened and endangered plants that occur in
areas of Florida where celery, lettuce, or endive is grown.
RISK MANAGEMENT AND
; , i:'!;,, : iiifi! .i;r: ':, *;<ซ!, ;ป' iv!.; '-"T -a ,ii ''.':ปป;*.si"M" iv-iii
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregisixation. 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 thiobencarb active ingredients. 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 thiobencarb. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of thiobencarb, 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 thiobencarb and to determine that thiobencarb can be used without
resulting in" unreasonable 'adverse"effete to 'Humans' and the environment. The Agency _
therefore finds that at this time all products containing thiobencarb 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 mat all uses of thiobencarb are eligible for
reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or requjje the submission 2^ ซi!i0.B^ ^al? !2 suJ?P.ort me registration of
products containing thiobencarb, 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 in this case, the
Agency has sufficient information on the health effects of thiobencarb, but has certain
limitations on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that thiobencarb products, if labeled and used
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as specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment. Under the Food Quality and Protection Act
of 1996, the Agency has determined that there is reasonable certainty that no harm will
result to infants and children or the general population from aggregate exposure to
thiobencarb. Therefore, the Agency concludes that all products containing thiobencarb
are eligible for reregistration. - " -
'2.
Eligible and Ineligible Uses
The Agency has determined that all uses of thiobencarb are eligible for
reregistration subject to conditions imposed in this RED.
C, Regulatory Position
The following is a summary of the regulatory positions and rationales for
thiobencarb. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Populations
EPA has determined that the established tolerances for thiobencarb 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
the aggregate exposures (both acute and chronic) from non-occupational sources, food and
drinking water, as well as the possibility of cumulative effects from thiobencarb and other
chemicals with a similar mechanism of toxicity.
Since there,are no residential or lawn uses of thiobencarb, no dermal or inhalation
exposure is expected in and around the home. No acute toxicity endpoints of concern have
been identified for thiobencarb.
In assessing chronic dietary risk, EPA estimates that thiobencarb residues in food
sources account for .<. 42.9 percent (%) of the RfD, and includes the highest-at-risk
subgroup, non-nursing infants. In drinking water thiobencarb residues account for 0.29
percent (%) of the RfD. Thus, the aggregate exposures from all sources of thiobencarb
(in this case, only dietary and drinking water exposures are relevant) account for 43.2
percent (%) of the RfD. Therefore, the Agency concludes that aggregate risks for.'th'e/,:,
general population resulting from thiobencarb uses are not of concern. . - r? V -I'v
" ".;' .'"*'
b. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for thiobencarb meet the safety
standard under the FQPA,amendment to section 408(b)(2)(C) for infants and children.
99
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,' ill!' Illiilp WBJ(HMMI "111!"! i*'i i{ll!
The safety determinatipn 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 toxic effects of thiobencarb residues in this population
subgroup.
to
;.. ' . toxic effects from thiobencarb residues, EPA considered the completeness of the data base
"": |,;,,, ' iij'for developmental anS'reproSuctiv'e effects, ''the""nature of "3ie effects observed, and other
"I1;1! ;' Information,
Based on current data requirements, thiobencarb has a complete data base for
"(,;!: : ,-> MI* {'.'(!' i ';-'ซ'i'Vi LWM;1' rt.:ซ 'S;T < :!*?ป s- u- ' i- r , w
developmental and reproductive toxicity. In the developmental studies, effects were seen
in the fetuses only at the same or higher dose levels than effects on the mothers. In the
reproduction study, no effects on reproductive performance were seen. EPA concludes
that it is unlikely that there is additional risk concern for immature or developing
organisms. Finally, the Agency has no epidemiological information suggesting special
sensitivity of iinfants and| children to .thiobencarb. Therefore, EPA finds that an additional
:!i ' , tm'celrMnty '"factor is no-t"warranted'fOT
EPA estimates that thiobencarb residues in the diet of infants and children account
for 42.9 percent of the RfD (29.5 for children 1-5) and residues in drinking water account
for 0.29 percent of the RfD. Thus the aggregate exposure from all sources of thiobencarb
:.. ';.' account for' 43.2 Jje^cent of the RfD"'for infants and' children. Therefore,.' the Agency
' '^ftclu^eTfnaTaggl^^^ from uses of thiobencarb'
are not of concern.
','. ._, ., ,... .. |n deciding to''continue to "make reregistiratipn Determinations during the early
stages of' FQPA' implernentaHon,1 EPA"' 'r^0"gnjggs ^l" |^" "w^j ^g necessary to make
decisions relating to FQP A 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 in 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.
:,ป;!.'.; ,f- V.'2. ""RiskMitigation ' ;
'. I,,! I s, '! i :'' III mil I '.| *. '""i,11" | | | | O
To lessen worker risk, and ecological and water quality risks posed by thiobencarb,
EPA is requiring the following mitigation measures from registrants of thiobencarb-
cdntaining products.
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To protect handlers:
For liquid formulations: mixers and loaders must used closed systems in
addition to wearing a chemical-resistant apron, chemical-resistant gloves,
long-sleeve shirt, long pants, shoes, and socks. Applicators and flaggefs
must use enclosed cabs or cockpits and wear long-sleeve shirt, long pants,
shoes, and socks. . .
- ' For granular formulations: loaders must wear a chemical-resistant apron,
chemical-resistant gloves, long-sleeve shirt, long pants, shoes, and socks.
Applicators and flaggers must wear chemical-resistant gloves, long-sleeve
shirt, long pants, shoes, and socks.
To protect-workers:
A restricted-entry interval of 24 hours is being imposed. Early entry
workers must wear coveralls, chemical-resistant gloves, shoes, and socks.
To protect non-target organisms:
Application restrictions are being mandated in the states of Louisiana and
Texas. In Louisiana, thiobencarb application will not be allowed south of
the Intracoastal Waterway. In Texas, thiobencarb application will not be
allowed within two miles inland from the shorelines of Galveston Bay,, and
not within two miles of Matagorda Bay.
Include label warnings preventing application to rice fields with
catfish/crayfish farming, and preventing application to rice fields adjacent
to catfish or crayfish ponds.
Where weather conditions permit, it is required that flood waters not be
released within 14 days.
Require that thiobencarb not be applied within 24 hours of rainfall, or
when heavy rain is expected to occur within 24 hours.
Require that thiobencarb not be mixed/loaded or otherwise handled within
100 feet of aquatic habitat.
Continue existing label warnings addressing environmental hazards, such
as restricting application aerially within one mile of the St. Francis
Floodway where the Fat Pocketbook Pearly Mussel is known ta occur.
Comparable warnings would be appropriate where use on rice can expose
other threatened and endangered mussels.
Work with the EPA to reassess in the Fall of 1998 thiobencarb use on leafy
vegetables in Florida based on the results of the currently . ongoing
environmental monitoring study for muck soils in Florida from the U.S.
Geological Survey's National Water Quality Assessment Program
(NAWQA).
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The Agency's concerns and risk mitigation measures are discussed in more
detail below.
3. Tolerance Reassessment Summary
The tolerances for plant and animal commodities listed in 40 CFR ง180.401(a) and
(b) are expressed in terms of the combined residues of thiobencarb and its metabolites
containing the chlorobenzyl and chlorophenyl moiety. A summary of thiobencarb
tolerance reassessments is presented in Table 41.
a. Tolerances Listed Under 40 CFR ง180.401(3."): Sufficient data are available to ascertain
the adequacy of the established tolerances for the following commodities listed in 40 CFR
ง180.401(a): cattle, fat; cattle, mbyp (meat byproducts); cattle, meat; eggs; goats, fat;
goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp;
horses, meat; mUk; poultry, fat; poultry, mbyp; poultry, meat; rice, grain; rice, straw;
sheep, fat; sheep, mbyp; sheep, and meat.
b. Tolerances Listed Under 40 CFR ง180.40irb'): Sufficient data are available to ascertain
the adequacy of the established tolerances with regional registration in accordance with 40
CFR ง180.l(n), for the following commodities listed in 40 CFR ง180'.401(b): celery,
endive (escarole), and lettuce.
Table 41. Tolerance Reassessment Summary for Thiobencarb.
|n . . , . / ft !'.'"i ', 'ix!' ::,r; !.".,: : :, ซ,
Commodity
Current Tolerance (ppm)
Tolerance Reassessment (ppm)
Tolerances Listed XJnder^O CIR 180.40%);
Cattle (fat, meat, mbyp)
Goat (fat, meat, mbyp)
Hog (fat, meat, mbyp)
Sheep (fat, meat, mbyp)
Poultry (fat, meat, mbyp)
Horse (fat, meat, mbyp)
Eggs
Milk
Rice, grain
Rice, straw
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.05
0.2
1.0
0.2
0.2
0.2
0.2
' 0.2
0.2
0.2
0.05
0.2
1.0
" ;TolerancesLisW Under 40 CER180.401(b):
Celery, Lettuce, Endive (escarole)
0.2
0.2
4. Codex Harmonization
III I III I I I I I I I I I I ','!' , ' ' ' ; ,'. '
No maximum residue limits (MRJLs) have been established by the Codex
Alimentarius Commission for thiobencarb residues in/on raw agricultural, animal, or
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processed commodities. Therefore, no compatibility questions exist with respect to U.S.
tolerances. ' ' '
5. Reference Dose (RfD)
The RfD/Peer Review Committee met on February 8, 1996, to discuss and
evaluate the existing and/or recently submitted toxicology data in support of the
thiobencarb reregistration and to reassess the RfD for this chemical.
The Committee recommended that the existing RfD for thiobencarb remain
unchanged. The RfD for this chemical was based on the two-year rat feeding study
(MRID# 00154506) with a NOEL of 20 ppm (1 mg/kg/day). At the next higher dose
level of 100 ppm (5mg/kg/day), decreased body weights and increased blood urea nitrogen
levels were observed. An uncertainty factor of 100 was applied to account for both inter-
species extrapolation and intra-species variability. On this basis, the RfD was calculated
by the Committee to be 0.01 mg/kg/day. ' .
6. Cancer Risk Assessment
The Agency has classified thiobencarb as a Group D chemical (not classifiable as
to human carcinogenicity). The carcinogenic potential of thiobencarb was evaluated by
the RfD/Peer Review Committee on February 8, 1996. The Committee considered the
carcinogenicity phases of the combined chronic toxicity/carcinogenicity studies in rats
(MRID# 00154506) and the carcinogenicity study in mice (MRID# 00086004) for
carcinogenic classification.
The highest dose level tested in the rat (500 ppm, or 25 mg/kg/day) was considered
to be adequate for carcinogenicity testing based on depression of cholinesterase activity
and reduced body weight gain. The highest dose level tested in the mouse (1600 ppm, or
235 mg/kg/day in males and 302, mg/kg/day in females) was considered to be adequate
based on body weight gain depression.
7. Occupational Exposure
At this time, all products containing thiobencarb are intended primarily for
occupational use (i.e. mixed, loaded, and applied by commercial applicators only;
generally not available to homeowners). No registered use is likely to involve applications
at residential sites. .
The Worker Protection Standard CWPS1
EPA's Worker Protection Standard for Agricultural Pesticides (WPS) affects all
pesticide products whose labeling reasonably permits use in the commercial or research
production of' agricultural plants on any farm, forest, nursery, or greenhouse. In general,
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WPS products had to bear WPS-complying labeling when sold or distributed after April
21, 1994, The WPS labeling requirements pertaining to personal protective equipment
(PPE), restricted-entry intervals (Rg^ ^ notification are interim. These requirements
are to be reviewed and revised, as appropriate, during reregistration and other Agency
review processes. At this time all registered uses of thiobencarb are within the scope of
the WPS.
; ........ -: ',3. .......... Handler Exposure and Risk
'
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For each end-use product, personal protective equipment and engineering control
requirements for pesticide handlers are set during reregistration as follows:
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baseline attire consisting of long-sleeve shirts, long pants, shoes, and socks. In addition,
loaders must wear a chemical-resistant apron. . .
Liquid Formulations: The Agency beEeves that risks resulting from intermediate-
term exposures to persons handling liquid formulations are overestimated due to
limitations with the hazard identification and dose-response assessment for the
intermediate-term endpoint, particularly in light of the absence of serious effects to these
target organs in either the subchronic neurotoxicity or rat chronic feeding study, which
suggest the lack of a deleterious response to thiobencarb by the kidney and/or liver.
Therefore, the Agency, drawing on its experience and expertise, has determined that risks
to handlers of liquid formulations will be adequately mitigated with the use of,engineering
controls and personal protective equipment. Mixers/loaders will be required to use closed
systems and wear chemical-resistant gloves and aprons in addition to baseline attire.
Applicators and flaggers will be required to use enclosed cabs or cockpits and wear
baseline attire.
b. Post-Application Exposure and Risk
Restricted-entry intervals, earlv-entrv PPE. and "double" notification:
The interim Worker Protection "Standard (WPS) restricted-entry intervals (REI's)
for agricultural workers are based solely on the acute dermal toxicity and skin and eye
irritation potential of the active ingredient. In addition, the WPS retains two types of
REI's established by the Agency before the promulgation of the WPS: (1) product-specific
REI's established on the basis of adequate data, and (2) interim REFs that are longer than
those that would be established under the WPS.
The WPS prohibits routine entry to perform hand labor tasks during the REI and
requires PPE to be worn for other e'arly-entry tasks that require contact with treated
surfaces.
"Double" notification is the_statement on the labels of some WPS pesticide products
requiring employers to notify workers about pesticide-treated areas orally as well as by
posting of the treated areas. The interim WPS "double" notification requirement was
imposed if the active ingredient is classified as toxicity category I for acute dermal toxicity
or skin irritation potential. '
During the reregistration process, EPA establishes REI's, early-entry PPE, and
double notification requirements based on, consideration of all available relevant
information about the active ingredient, including acute toxicity, other adverse effects,
epidemiological information, and post-application data. EPA is establishing a 24-hour REI
and the following early-entry PPE for all in-scope WPS uses of products containing
thiobencarb; coveralls, chemical-resistant gloves, socks, and shoes. EPA has determined
that double notification is not required.
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The surrogate ppst-appHcation exposure and risk assessment indicates that risks to
post-application (reentry) workers should be acceptable provided entry is postponed until
at least 24 hours following application. Since thiobencarb is applied early in the season,
when crops and weeds are small, the agency anticipates that the dermal exposures will be
relatively low. The Agency also concluded that the types of post-application tasks,
including scouting, thinning, or hoeing, performed at this point in the crop cycle are not
likely to result in intermediate-term exposures. The Agency also determined that early-
entry personal protective equipment consisting of coveralls, chemical-resistant gloves, and
socks plus shoes would" Be:"adequatelyprotective^ if workers must enter during the
restricted-entry interval as permitted under the Worker Protection Standard.
< c. Other Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the
labeling of all end-use products containing thiobencarb. For the specific labeling
statements, refer to Section V of this document.
8. Ecological Effects Risk Management
In general, the risk assessment showed various levels of concern (LOG)
regarding chronic effects to fish and freshwater invertebrates, including shrimp and
mollusks, and high risk of causing acute effects to freshwater and estuarine invertebrates.
The following is a regional account of thiobencarb risk mitigation measures for ecological
effects.
,8!!!'!
'511!
a. Southeastern United States (Texas, Louisiana)
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Study findings indicate that the use of thiobencarb on rice in the southeast regions
poses a high acute risk to estuarine fish, crustaceans (including shrimp), and mollusks at
times of high exposure resulting from'"heavy rainfall occurring soon after application.
For acute effects to aquatic invertebrates, calculated risk quotients are 0.83 and
0.64, respectively, which are greater than the LOG for presumption of high risk, 0.5.
These results indicate that the risk to freshwater invertebrates posed by use of thiobencarb
on rice in the southeastern regions range from low to high, depending on the weather and
local conditions. High risk probably is limited to aquatic habitats near the discharge of
tailwater and during times when heavy rainfall occurs soon after thiobencarb is applied.
For chronic effects to aquatic invertebrates, based on a chronic toxicity study with
the Daphnia magna, thiobencarb is predicted to cause chronic effects in freshwater
invertebrates when concentrations remain near or above 1 to 2 ppb for an extended period
of days. Aquatic residues measured during biological field studies indicate that this
condition will commonly occur in areas where thiobencarb is applied. Findings indicate
that use of thiobencarb on rice in the southeast regions poses a definite high risk of causing
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chronic effects to freshwater invertebrates. Adverse effects to freshwater invertebrates are
expected to occur frequently.
For effects to estuarine and marine organisms, based on aquatic residues measured
.in the biological field study at Halls Bayou, use of thiobencarb on dry-seeded rice can
result- in concentrations of thiobencarb of 690 ppb. This represents a near worst-case
scenario when heavy rainfall occurs immediately after thiobencarb is applied.
Concentrations this great would exceed the acute LC50 for the mysid (150 ppb) and eastern
oyster (320 ppb), and would be close to the LC50 for the sheepshead minnow (660 ppb).
They would also approach or exceed the LC50 values that Borthwick et al. (1985) reported
for the Atlantic silverside, tidewater silverside, and California grunion.
Other than the one measurement of 690 ppb, however," concentrations in Halls
Bayou were not greater than 83, ppb. Furthermore, two years of sampling in the
biological field study near Matagorda found that residues reached a,maximum of 21 ppb.
Using the exposure value of 83 ppb, the risk quotients for fish, mollusks, and shrimp are
0.13, 0.26, and 0.55, respectively.. This indicates that, under conditions Bother than those
described above, the acute risk is minimal to fish-and mollusks. The RQ still exceeds the
LOG, however, for high risk for shrimp and other crustaceans.
The measured concentration of 690 ppb, representing a high exposure associated
with heavy rainfall, indicates a high chronic risk to fish and crustaceans \ In addition, a
high chronic risk to crustaceans exists even for exposures measured not associated with
heavy rainfall. The MATC from chronic studies with crustaceans found MATCs that
ranged from 4.5 to 35 ppb.. Water concentrations measured near Matagorda exceed the
lower bound of this range, and those measured at Halls Bayou exceed even the upper
bound of this range. The lower end of the range was .sometimes exceeded for several
consecutive days in both of the biological field studies (for example, 8 days in Area II of
Halls Bayou, 4 days at Station 1 on the.canal in.the Matagorda study in-1984). It is
evident that use of'thiobencarb on rice in the southeastern regions poses a high chronic risk
to shrimp and other aquatic crustaceans. ~ ' .-,
* ' '" '
In summary, based on the results of these tests, the Agency has decided to prohibit
application of thiobencarb south of the Intracoastal Waterway in Louisiana; prohibit
application within two miles of Galveston Bay, in Texas, and within two miles'of
Matagorda Bay, in Texas; and prohibit the release of permanent flood water within 14-
days of application of thiobencarb, when feasible (depending on weather patterns).
Additionally, the Agency mandates that thiobencarb is not applied within 24 hours
of rainfall, or when heavy rain is expected to occur within 24 hours. Lastly,, the Agency
requires that thiobencarb is not mixed/loaded or otherwise handled within 100 feet of an
aquatic habitat.
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b.
Florida
[is!
Study results indicate that use of thiobencarb on vegetables in Florida, at the
maximum label rate, poses an risk to freshwater invertebrates due to both acute and
chronic effects. Because the chronic risk quotients are extremely high, chronic effects on
aquatic invertebrates may be high, depending on the environmental transport of
thipbencarb through the muck soils 'on" which" the active ingredient is applied. The risk to
aquatic habitat in Florida, primarily the nothern stretches of the Everglades and the
Loxahatchee National Wildlife Refuge, at this time is uncertain.
Study results indicate that use of thiobencarb on vegetables in Florida, at the
maximum label fate, may pose"a high acute risk'fo marine/estuarine oysters, shrimp, and
other aquatic invertebrates. The RQ for chronic effects to shrimp and other
marine/estuarine invertebrates is imprecise because only supplemental data are available.
Nevertheless, based on the range of findings from the four available supplemental studies,
it is clear that the RQ for these organisms is well above the LOG of 1, signifying a high
chronic risk. The acute RQ for marine estuarine fish in Florida is less than the LOG of
0-5, indicating the acute risk is not high, but it is greater than the LOG of 0.1, indicating
that restricted use may be applied, depending on the results of ongoing environmental
monitoring studies.
At this time, the Agency believes that the main concern for thiobencarb use on
leafy vegetables in Florida is the fate and transport of thiobencarb to aquatic ecosystems,
again, due to the pjoximity of Mobencarb application to the northern portion of the
Everglade's and""the LolcaTfiatoh'e^'l^ation^'^ndliTe'' Refuge. At this time, very limited
information is available on thiobencarb concentrations in the ground and surface water
travelling to these habitats. The National Water Quality Assessment Program (NAWQA),
currently being conducted by the U.S. Geological Survey, is collecting water samples in
southern Florida and analyzing the samples for pesticides, including thiobencarb15.
Interpretation of the NAWQA monitoring data will be delayed until the collection, quality
control, and analysis of the data have been completed in the Fall of 1998. At that time,
the Agency will reevaluate the exposure that thiobencarb poses to aquatic habitats in
Florida, and reassess the need for any risk mitigation measures for thiobencarb use in the
state of Florida.
c.
California
Granular thiobencarb is used only on rice grown ir California. , Granular
thiobencarb is estimated to pose chronic risi:"to terrestrial species, but the risk is uncertain.
1 To date, testing for thiobencarb has only been completed for approximately 16 samples that were taken in
the Fall of 1996 into the Winter of 1997. Thiobencarb was not detected in these samples. However, the Agency
believes that it is premature to draw any conclusions from these data since these data do not include sampling for the
application period for thiobencarb (April/May).
iiilr i,, III I III II I I II |l ' ' ' ' ,i ' ' '
-' ' 108
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Measured aquatic residues from monitoring in California were no greater than 37
ppb. An acute risk quotient based on this value is 0.37, which is less than the LOG of
0.5. Therefore, use of thiobencarb on rice in California is expected to pose minimal acute
risk to freshwater invertebrates. "
Use of thiobencarb on water-seeded rice in California is predicted to pose less of
a chronic risk to aquatic invertebrates than in the southern rice-growing regions. Water
sampling from the Sacramento River and San Joaquin River show that thiobencarb
concentrations never exceeded 1 ppb, the NOEC for Daphnia magna. The majority of
readings were less than 0.05 ppb. In contrast, concentrations in smaller waterways
occasionally approached or exceeded the NOEC of 1 ppb, as well as the MATC of 1.7
ppb.
The use of the thiobencarb granular formulation in California is regulated under
the Basin Plan for the Sacramento River Basin established by the California Regional
Water Quality Control Board, Central Valley Region. A performance goal of 1.5 ppb is
strictly monitored, and growers must adhere to a program of approved management
practices, including a 30-day water holding restriction.
. The Agency proposes no risk mitigation measures for granular thiobencarb use in
California.
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.
10. Endangered Species Program
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 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 in county-specific bulletins or by other
site-specific mechanisms as specified by state partners. A final program, which may be,
altered from the interim program, will be described in a future Federal Register Notice.
' 109
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The Agency is not imposing label modifications at this time through the RED. Rather,
any requirements for product-use modifications will occur in the future under the
Endangered Species Protection Program.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
/A'. 'Sanufacturing-tlse Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of thiobencarb for the above
eligible uses has been reviewed and determined to be substantially complete. For
confirmatory purposes, the following information will need to be submitted:
Dermal Penetra^on Study [GLN85-2J;
The dermal absorption factor in the current risk assessment is 60.2 percent,
observed at 10 hours!' TEfclactpr is considered by the Agency as a worst-case
scenario since the skin was washed approximately 1 hour prior to dosing rather
than the recommended 24 hours (which would allow for normal replacement of
skin oils). The Agency views this as an over-estimate of absorption, resulting in
significantly lower estimates for margin of exposure to workers, specifically
intermediate-term exposure. A new dermal penetration study is requested for the
granular and liquid thiobencarb formulations to confirm that intermediate-term
exposure to workers is acceptable.
Life-Cycle Freshwater Fish Study [GLN 72-5];
There is currently no core data on the chronic effects of thiobencarb on fish
(freshwater or saltwater). Use of thiobencarb on rice is expected to result in
extensive exposure to freshwater habitats, thiobencarb degrades slowly in water,
and the EEC for thiobencarb exceeds 1/10 the NOEC determined in a fish early
life-stage study/invertebrate life-cycle study, thus triggering the need for the study.
Avian Subacute Toxicity Study[GLN71-2(b)];
fvfo acute toxicity data are available for a waterfowl species. Therefore, an
additional study must be submitted testing the avian dietary toxicity of technical
thiobencarb to a waterfowl species, preferable the mallard. The value added of
these data is moderate. There is a chance that the mallard may be more sensitive
to thiobencarb than the bob white, and this could change the conclusion of the risk
assessment. In general, however, the acute toxicity of thiobencarb is not a major
concern.
110
iii in11 in in ill
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Avian Reproduction Study [GLN 71-4(b)]; , -
A core avian reproduction study has been submitted for an upland game species
(the bobwhite), but only a supplemental study is available for a waterfowl species
(the mallard). This supplemental data for the mallard indicates that it is the moire
sensitive species and was thus used in the risk assessment. The data requirement
for an avian reproduction study with a waterfowl is still outstanding. The
conclusion of the risk assessment is not dependent on these data since high risk
could be concluded based on the results of the core study with the bobwhite.
Seedling-Emergence Testing Study [GLN 123-1 (a)];
The guideline requirement for seedling emergence testing is currently only
partially fulfilled. The test was classified supplemental for the two most sensitive
species, lettuce and ryegrass, because there was significant mortality of plants at
the lowest test concentration. The Agency requests that additional testing be done
for these.two sensitive species using lower test concentrations that do not result in
mortality of plants. The value added of this information is moderate. It would
increase the confidence of the risk assessment on terrestrial plants. Also, this
information would be required for comparative analysis of thiobencarb with other
. herbicides. .
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 an Herbicide for the following use(s):rice weed control
in California, Louisiana, Texas, Mississippi, Missouri and Arkansas, and lettuce,'
.endive and celery weed control in Florida."
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)."
111
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1 ' < .(III : SB! ii) >i
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The reregistration requirements for magnitude of the residue in water will be
consider^ fulfilled when revisions are made to Valent's end-use product labels (EPA Reg.
Nos. 59639-79 and 59639-80) to prohibit use of treated water for livestock watering or
for drinking or irrigation for a specified time period after treatment. Based on the results
of an acceptable magnitude of residue in potable water study (MRIDs 43404003,
43404004, and 43404005), thiobencairb and thiobeiicarbsulfoxide residues in runoff and
receiving waters associated with rice fields did not fall to acceptable levels until 14 days
after treatment. ;
The use of the thiobencarb granular formulation (Boleroฎ 10G, EPA Reg. No.
59639-80) in!'California is ^^3^uncier the gasin Planfor'the Sacramento River Basin
established by the California Regional Water Quality Control Board, Central Valley
Region. A performance goal of 1.5 ppb is strictly monitored, and growers must adhere
to a program of approved management practices, including a 30-day water holding
restriction.
The reregistration requirements for nature and magnitude of the residue in fish will
be fulfilled when label revisions are made on Valent's end-use products (EPA Reg. Nos.
59639-79 and 59539:35) ^ spec,j|y ^ g^o^n^-~~-& restrictions: "Do not use on rice
paddies where commercial catfish or crayfish farming is practiced. Do not use adjacent
to catfish or crayfish ponds."
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Valent's thiobencarb end-use labels specify a 6-month plantback interval following
rice and all other crops, except celery, endive and lettuce for which rotational crop plant-
back intervals are 4-months. These currently specified plant-back intervals are
appropriate.
B. End-Use Products
1. Additional Product-Specific Data Requirements
mi i i i i mi i n i i i i i i i i i i i i i in mi ' , ' . , ;
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. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA1 s current regulations
and requirements as specified in 40 CFR ง156.10 and other applicable notices.
112
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a. PPE and Engineering Control Requirements for Pesticide
Handlers
For sole-active-ingredierit end-use products that contain thiobencarb:
Revise the product labeling to adopt the handler personal protective
equipment/engineering control requirements set forth in this section.
Remove any conflicting PPE requirements on the current labeling.
For multiple-active-ingredient end-use products that contain thiobencarb:
Compare the handler personal protective equipment/engineering control
requirements set forth in this section to the requirements on the current
labeling.
Retain the more protective requirements. (For guidance on which
requirements are considered more protective, see PR Notice 93-7.)
3.
Products Intended Primarily for Occupational Use
Active-Ingredient Specific Engineering Control Requirements
a.
EPA is establishing active-ingredient specific engineering controls for some
occupational uses of thiobencarb end-use products.
For liquid formulations: .
"Mixers and loaders are required to use closed systems. The closed system
must be used in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240(d)(4)." ' . '
"Applicators and flaggers are required to use enclosed cabs or enclosed cockpits.
The closed system must be used in a manner that meets the-requirements listed in
the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240(d)(5-6)."
4. Active-Ingredient Specific Personal Protective Equipment
Requirements
EPA is establishing active-ingredient specific personal protective equipment
requirements for all occupational uses of thiobencarb end-use products.
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For Uquid formulations:
"In addition to using closed systems, mixers and loaders must wear:
-- long-sleeved shirt and long pants,
=rchemical-resistant gloves*,.
socks plus shoes, and
.Chemical-resistant apron."
"Applicators and flaggers using enclosed cabs or cockpits must wear:
- long-sleeved shirt and long pants, and
socks plus shoes."
I Ill MI i i i i i| i i i i II il i i I ..... ! "L '. : ,, ' ' i1.
Ill 111 I I I I I I I I Ml II I I I .1 " !. 1 ,: .' ' ''.', . - i"
''tor other handling activities and in case of a spill or other emergency exposure,
handlers must wear; ' , .
coveralls over long-sleeved shirt and long pants,
-^chemical-resistant gloves*,
chemical-resistant footwear, and
chemical-resistant apron when cleaning equipment."
*Fbf the glove statement, use me statement established for thiobencarb through the
instructions in Supplement Three of PR Notice 93-7.
For granular formulations:
"Applicators and other handlers must wear:
= long-sleeved shirt and long pants,
chemical-resistant gloves*,
shoes plus socks
chemical-resistant apron when loading formulation into equipment or cleaning
.- .; "^\:. ."equipment."
*For the glove statement, use the statement established for thiobencarb through the
instructions in Supplement Three of PR Notice 93-7.
5. Determining PPE Labeling Requirements for End-use Products
Containing This Active Ingredient
The PPE that would be established on the basis of the acute toxicity category of the
end-use product must be compared to the active-ingredient specific personal protective
equipment specified above, the more protective PPE must be placed on the product
labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
114
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6. Placement in Labeling
The perso.nal protective equipment requirements 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.
t ',,-"" - '
7. Entry Restrictions
For sole-active-ingredient end-use products that contain thiobencarb:
. Revise the product labeling to adopt the entry restrictions set forth in this
section.
Remove any conflicting entry restrictions on the current labeling.'
For multiple-active-ingredient end-use products that contain thiobencarb:
Compare the entry restrictions set forth in this section to the entry
restrictions on the current labeling. "
Retain the more protective restrictions. (A specific time period in hours or
days is considered more protective than "sprays have dried" or "dusts have
' settled.")
8. Products Intended Primarily for Occupational Use
a. WPS Uses
(1) Restricted-entry interval:
A 24-hour restricted-entry interval (REI) "is required for uses within the scope of
the WPS on all thiobencarb end-use products.
(2) Early-entry personal protective equipment (PPE):
The PPE required for early entry is:
coveralls,
chemical-resistant gloves,
shoes plus socks,
b. 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
115
-------
.!,'" I1 U'Jia i "||l|!l If ! ,
into the standardized early-entry PPE statement required by Supplement Three of PR
Notice 93-7.
, ' ll'lllll! ..... .rill' '", ,. I'l ...... , i,,l. "W 'I W'NI :l .......... Hi' '"IIP: Li' , .1.
1 'EM i, 'IT iiUliilllI'lil'l' ViiVS I'llf'L'L'11 'nlii'l" VI1 li'll IHIT "iHT",.1,
Other Labeling Requirements
Application Restrictions
I I 111 I I II I I III I II I II II I I III I i ,T ' . , . ,'!' ' '' " ' ,',''
"Do not apply this product in a way that will contact workers or other persons,
either directly or indirectly or through drift. Only protected handlers may be in
the area during application. "
-Do not apply this product south of the Intracoastal Waterway in Louisiana."
f Do not apply this product within two (2) miles from the shorelines of Matagorda
Bay in Texas."
"Do not apply this product within two (2) miles from the shorelines of Galveston
Bay in Texas."
I IP I Ml III ,1 III I I I I I '."".. ;!V " ; ';' ;^| .<(/
?Do not apply this product to rice fields with catfish/crayfish farming."
"Do not apply this product on rice fields adjacent to catfish or crayfish ponds."
"When applying to rice fields, do not release permanent flood water within 14-
days of application of this product (where weather permits)."
"Avoid application of this product within 24 hours of rainfall, or when heavy rain
is expected to occur within 24 hours."
"Do not mix/load or otherwise handle this product within 100 feet of aquatic
habitat."
User Safety Requirements
1. Registrants: place the following statement on the labeling if coveralls are
required for pesticide handlers on the end-use product label:
' , '! ' ' i'|, ''' i, ,'ป!' ' j1
"Discard clothing or other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them."
2. Registrants always place the following statement on the end-use product
labeling: : "
"Follow manufacturer's instructions for cleaning/maintaining PPE. If not
such instructions for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
116
-------
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. Wash
the outside of gloves before removing.- As soon as possible, wash
thoroughly and change into clean clothing."
C. Spray Drift Labeling
The following language must be placed on each product label that can ,be applied aerially:
Avoiding spray drift at the application site is the responsibility of the appk'cator.
The interaction of many equipment-and-weather-related factors determine the
potential for spray drift. The applicator and the grower are responsible for
considering all these factors when making decisions.
The following drift management requirements must be followed to avoid off-target-
drift movement from aerial applications to agricultural field crops. These
requirements do not apply to forestry applications, public health uses or to
applications using dry formulations.
1.
2.
The distance of the outer most nozzles on the boom must not exceed
3/4 the length of the wingspan or rotor.
Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
. ป
It is recommended that the applicator should be familiar with and take into account
the information covered in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained in the
product labeling: .
[This section is advisory in nature and does not supersede the mandatory
label requirements.]
117
-------
f1:1!'1 ..... ri'
:]IIB
I" !>'1{; j ipi
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 Huniid'ityV11^^"^eniperafure Inversions).
" /'^/iivrnnDf\ฅTTTVT^"* T^TD^^TDirT7TT1 Ch tii*
Vซf\fr,L^( JL JtvV/JL/JL/JLli i vJ J^9,t^\_ffr M^SL*J f >J_I..F-*?/ *
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
Jjigher flow rates are needed, use higher flow rate nozzles instead of increasing
pressure.
Number of nozzles - Use the minimum number of nozzles that provide
uniform coverage.
Nozzle Orientation - Orienting nozzles so that the spray is released parallel
to the airstream,produces larger droplets than other orientations and is the
lecommended practice. Significant deflection from horizontal will reduce droplet
size and increase drift potential.
Illl Ill I I II I III I I I I I I I II III II III , T f'l , ' ''! ' i* , ' ' ' ' '
Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
^drpplets. Consider using low-drift nozzles. Solid stream nozzles oriented straight
back produce the largest droplets and the lowest drift.
i Maintainance of Nozzles - periodic inspection and subsequent replacement
of nozzles to ensure proper chemical application is recommended.
II II I II I I I I I II ' , i ' ' i " . '
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
118
D!" S, IV.l'i'f lt!\;;i"!:}'!!ป
-------
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.
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 endangered1 species, non-target crops) is minimal (e.g.
'when wind is:blowing away from the sensitive areas).
D. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
Eligibility Decision (RED). Persons other than the registrant may generally
distribute or sell'such products for 50 months from the date of the issuance of this
RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and
119
-------
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
thiobencarb products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency-
imposed label changes and existing stocks requirements applicable to products they
sell or distribute.
120
-------
VI. APPENDICES
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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 2665 covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to 2665 in 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 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in 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:
, i '
, 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.
129
-------
130
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
Thiobencarb
REQUIREMENT
USE PATTERN CITATIONCS)
PRODUCT CHEMISTRY
61-1 .
61-2A .
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-6
63-7
63-8 .
63-9
63-11 .
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor . '
Boiling Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
PH
Stability , '
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL.
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41609003
44507, 41609001
44507, 41609001
44507, 41609002
140158, 41609002
44507, 41609002
44507, 41609002
44507, 41609002
44507, 41609003
140158 ,
44507
140158
140158
44507
44507
44507
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1B
72-1C
72-1D
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
. Fish Toxicity Rainbow Trout- TEP .'
ALL
ALL
B, D
B, D
B,D
B, D
B, D
ALL
B, D
43121201 ,
55224
57225 .
43075401
25778 .
50665
50665
50664
50664
131
-------
Data Supporting Guideline Requirements for the Reregistration of
Thiobencarb
REQUIREMENT
USE PATTERN
CITATION(S)
72-2A Invertebrate Toxicity ALL
72-2B Invertebrate Toxicity-TEP B,D
72-3A Estuarine/Marine Toxicity - Fish B, D
72-3B Estuarine/Marine Toxicity - Mollusk B, D
72-3C Estuarine/Marine Toxicity - Shrimp B, D
72-3D Estuarine/Marine Toxicity Fish- TEP B, D
72-3E Estuarine/Marine Toxicity Mollusk - TEP B, D
72-3F Estuarine/Marine Toxicity Shrimp - TEP B, D
72-4A Early Life Stage Fish B~' D
72-4B Life Cycle Invertebrate B, D
72-6 Aquatic Organism Accumulation B, D
122-lA Seed Germination/Seedling Emergence B, D
122-1B Vegetative Vigor B[, D
122:2 Aquatic Plant Growth B, D
123-1A Seed Germination/Seedling Emergence B, D
123-lB Vegetative Vigor B, D
123-2 ASua,ti? Plant Growtn ?. P.,
TQXICC)LOGf ''' ' ' ' ''";;': " ''"; :' : ::":"''":' ::: "'' ''";'":';::
81-1 Acute Oral Toxicity - Rat ALL
81-2 Acute Dermal Toxicity - Rabbit/Rat ALL
81-3 Acute Inhalation Toxicity - Rat ALL
81-4 Primary Eye Irritation - Rabbit ALL
81-5 Primary Dermal Irritation - Rabbit ALL
81-6 Dermal Sensitization - Guinea Pig ALL
81-7 Acute Delayed Neurotoxicity - Hen ALL
8l-f-SS Acute Neurotoxicity
82-2 21~Davn Dermal - Rabbit/Rat ALL
82-4 90-Day Inhalation - Rat ALL
82-7-SS 90-Day Neurotoxicity
' ' """ ' '" ' ''' - ' ."""''-' 132
25788
40031001
79110, 79112
79114
50667,79117
79111
79115
79113
79112
42680401
133563
41690902
41690902
41690901,41690902
41690902
41690902
41690901, 41690902
42130701
42130701
40585, 134976
40581
40583, 81900
161699
42987001, 43148202
42987001
42893001
42893001
43001001
-------
Data Supporting Guideline Requirements for the Reregistration of
Thiobencarb
REQUIREMENT
83-1 A
83- IB
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
85-2 .
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism /
Dermal Penetration
USE PATTERN CITATiON(S)
ALL
ALL
ALL
ALL
. ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
154506 ' ' '
144742
154506
86004
86873, 93691,
115248
164313 :
40446201, 40985701
135285, 84131,
41174
84133, 40352401
40352401
' 42340302
41215311
ENVIRONMENTAL FATE . ' . . ' . ' . .,.
160-5
161-1
161-2
161-3
162-1
162-3
162-4
163-1
164-1
164-2
165-2
165-3 '
165-4
201-1
202-1
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Terrestrial Field Dissipation
Aquatic Field Dissipation
Field Rotational Crop *
Accumulation - Irrigated Crop
Bioaccumulation in Fish
Droplet Size Spectrum
Drift Field Evaluation
ALL
,B, D
B, D
B
B
B, D
D
B,D
B
D
B
D
B,D
B, D
B,D
41609003
41609012
42257801
41215312
43300401
43252001
42052001
43150601 ,
43404004, 42003405
43404004, 42003405
41609011
43148201
42460401
TASK FORCE
TASK FORCE
133
-------
: ,'!!. ' : :;i T"'1'" I':;1"'::,!!1!1' ! 'OMI'i*1'
Ijlrilj|i|!;, ^a||,gupporting Guideline Requirements for the Registration of
Thiobencarb
REQUIREMENT
USE PATTERN
CITATION(S)
:-; ":,-,::,: RESIDUE CHEMISTRY
M;!'l tl;;!f ! . .; ' PHI W. ' a'iSr'1""1!"!1:",!";;' : lilllli: m-K i.'M: S'VS'JW C fi! i' f f !'} ' E I ',iif;i! * rM ' <; !" I ':
Residue Analytical Method - Animal
Storage Stability
Magnitude of Residues - Potable H2O
Magnitude of Residues - Irrigated Crop
i i iiil i i
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials
iiiii i
Processed Food
V, >i .......... f-iyr
;ii: ..... ('.:.' ,!: j 1 1
-'M ...... :' .':. iWlBl!,,1!!;1 !'
, Wl, ......... l/'iC!1 'j
ALL .....
B
B,D
^'J'IM^i:'
B"
ALL
D
D
i
B
B,D
i i
ALL
4234Q301
43492301
43075402
92182073
43182501
43404003,43404004
124278
42962801, 42962802
92182080
42987002
v if
I!!!' ป i; " I I '
134
-------
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 support of past regulatory
decisions. Selections from other sources including the published literature, in 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 no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency was
unable to determine or estimate the date of the document.
c.
Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets. .
135
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Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
deipribing the earliest known submission:
(1)
(2)
(3)
(4)
Submission date. The date of the earliest known submission appears immediately
following the word "received."
A3ministratiYง 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.
III
ill;' :::!],:! ';:" ffi1,: , svch! i!!!;!S, 13 iiiS: 'ซii:P't! Irif!:';:i!:,i/; ':-siillp-ilfi!1,!!*' r i!,'!!ty.&i,'<>'; ; i:'. .'*'.,' ' " ' 1' ':i';!,
Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number follows
the symbol "CDL," which stands for "Company Data Library." This accession
number is in turn followed by an alphabetic suffix which shows the relative
position of the study within the, volume.
liEUf
!l lit!
136
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BIBLIOGRAPHY
MRID
CITATION
00025778 Beavers, J.B.; Fink, R.; Joiner, G.; et al. (1979) Final Report: One-Generation
, Reproduction Study-Mallard Duck: Project No. 162-117. (Unpublished study including
letters dated Apr 10, Apr 25, May 25, Jul 9, Jul 24, Aug 28, 1979 from J, Grimes, J.B.
Beavers, J.B. Leary, J. Grimes, J. Grimes, J. Grimes, respectively, to Francis X.
Kamienski and addendum, received Dec 11, 1979 under 239-2450; prepared by Wildlife
international, Ltd., submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
241489-G)
00025788 Wheeler, R.E. (1978) 48 Hour Acute Static Toxicity of Bolero (SX796) to 1st Stage
Nymph Water Fleas (Daphnia magna Straus). (Unpublished study received Dec 11, 1979
under 239-2450; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:241489-W)
00040581 Rittenhouse, J.R.; Narcisse, J.K. (1974) S-717: The Eye Irritation Potential of Bolero
Technical: SOCAL 653/XX: 106. (Unpublished study received Mar 18, 1976 under
239-EX-78; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:095493-P)
00040583 Rittenhouse, J.R.; Narcisse, J.K. (1974) S-718: The Skin Irritation Potential of Bolero
Technical: SOCAL 654/XX:106. (Unpublished study received Mar 18, 1976 under
239-EX-78; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:095493-R)
00040585 Narcisse, J.K. (1976) S-959: The Acute Inhalation Toxicity of Bolero Technical Vapor:
SOCAL 885/XXI:r48. (Unpublished study received Mar 18, 1976 under 239-EX-78;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:095493-T)
00041174 Shirasu, Y.; Moritani, M.; Kato, K, (1974) Test Report on Mutagenicity of
S-(4-Chloroben2yl)-N,N-diethylthiolcarbamate in Microorganisms. (Unpublished study
received Mar 18, 1976 under 239EX-78; prepared by Institute of Inbiomental
Toxicology, submitted by Chevron Chemical Co., Richmond, Calif.; CDL:095491-D)
00044507 Leary, J.B. (1976) Benthiocarb-Distribution between n-Octanol and Water: File No.
741.11. (Unpublished study received Mar 18, 1976 under 239-2449; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:095095-N)
00050664 Thompson, C.M.; Griffen, J.; Boudreau, P.; et al. (1980) Acute Toxicity of Bolero 10G
(SX-1252) to Rainbow Trout (Salmo gairdneri): S-1819: ABC Report # 26078.
(Unpublished study received Oct 23, 1980 under 239-2449; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:243574-B)
137
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BIBLIOGRAPHY
MRID
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00050667
!WI|"i"" .' 'II si
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00079113
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(SX-1252) to Bluegill Sunfish (Lepomis macrochirus): S-1820: ABC Report # 26077.
(Unpublished study received Oct 23, 1980 under 239-2449; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:243574-C)
Hollister, T.A. (1980) Acute Toxicity of Boleroฎ = Technical to Mysid Shrimp
'(Mysi^^'ba^:^^No. BP-80:9-16L oSn^ubh'shed study received Oct 23, 1980
under 239-2449; prepared by EG"&G"Bionomics^ submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:243574-E)
I ' ",','
Fletcher, D. (1974) Report to Chevron Chemical Company, Ortho Division: 8-Day
Dietary LC50 Study with Bolero in Bobwhite Quail: IBT No. 651-05214. (Unpublished
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095494-H)
Fletcher, D. (1974) Report to Chevron Chemical Company, Ortho Division: 8-Day
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(Unpublished study received Mar 18, 1976 under 239-2449; prepared by Industrial
Bio-Test Laboratories, Inc., submitted by Chevron Chemical Corp., Richmond, Calif.;
CDL:095494-I)
HeitmuUer, T. (1979) Acute Toxicity of Bolero Technical to Sheepshead Minnows
(.Cyprinodon variegatus): Report No. BP-79-9-133. (Unpublished study received Dec 11,
1979 under 239-2449; prepared by EG & G, Bionomics, submitted by Chevron
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HeitmuUer, T. (1979) Acute Toxicity of Bolero 8 EC to Juvenile Sheepshead Minnows
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1979 under 2392449; prepared by EG & G, Bionomics, submitted by Chevron Chemical
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Ward, G.S. (1979) Effects of Boleroฎ = Technical on Survival, Growth, and
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EG & G, Bionomics, submitted by Chevron Chemical Co., Richmond, Calif.;
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Heitmulier, T. (1979) Acute Toxicity of Bolero 8 EC to Fiddler Crabs (Uca pugilatof):
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138
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BIBLIOGRAPHY
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Hollister, T. (1979) Acute Toxicity of Chevron's Bolero 8 EC to Embryos-larvae of
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Hollister, T.A. (1979) Acute and Chronic Toxicity of Boleroฎ = Technical to Mysid
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11, 1979 under 2392449; prepared by EG & G, Bionomics, submitted by Chevron.
Chemical Co., Richmond, Calif.; CDL:241494-T)
Rittenhouse, J.R.; Narcisse, J.K. (1974) The Skin Irritation Potential of Bolero
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under 5G1582; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:094343-N)
Bullock, C.H. (1977) The Potential of Benthiocarb Technical and Benthiocarb Standard
to Mutate Histidine-deficient Strains of Salmonella typhimurium: SOCAL 1017/XXV:8
(S-1071). (Unpublished study received Dec 11, 1979 under 6F1763; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:099125-G)
Bootman, J.; Whalley, H.E. (1978) Boleroฎ = (Thiobencarb): Dominant Lethal Study
in Mice after Acute and Subacute Oral Administration: LSR Report No. 78/KCI38/294.
(Unpublished study received Dec 11, 1979 under 6F1763; prepared, by Life Science
Research, England, submitted by Chevron Chemical Co., Richmond, Calif-
CDL:099125-I) . '
Macrae, S.M.; Amyes, S.J.; Holmes, P.; et al. (1981) Technical Boleroฎ =: Potential
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Science Research, England, submitted by Chevron Chemical Co., Richmond, Calif.;
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Chevron Chemical Company (1981) Additional Data for the Teratology Study in Rats
with Bolero: Ortho Test No. S-1947. (Unpublished study, including letter dated Jan 11,
1982 from J.A. Parker to D.F. Dye, received Jan 15, 1982 under OF2322-
CDL:070594-A)
139
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Ill II11
MRID
BIBLIOGRAPHY
CITATION
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00133563
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00135285
00140158
00144742
Harris, S.; Holson, J.; Fite, K.; et al. (1982) Teratology Study in Rats with Bolero
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Pill III I I II III I I II I III I I II I III II I I ' ' ' . ''I . ' " ฐ
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11 !ป; JI, i|l|;:il ',1 1:,, 'I'll'' IIIIIIIIIIIIIIJ1' I, J.'J]'1!1:!;!!!!;1.1 iillll, I ,,l! ;| ""i lill'"!;',,!; "in, 'Ini !l,ii!;!l!! i 'i lilliiE" !ii,i :,i,
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Sunlight: Project ID MEF-0010. Unpublished study prepared by the Pharmacology and
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42003404
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42130701
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42340301
4234Q3Q2
424604dl
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Northern Bobwhite: Lab Project Number: 263-128. Unpublished study prepared by
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4-Chlorobenzylmethylsulfonej 4-Chloroben2ylmethylsulfoxide, and 4-Chlorobenzoic
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i
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43148202
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144
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
GENERIC DATA CALL-IN NOTICE
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam: .
This Notice requires you and other registrants of pesticide products containing the
active ingredients) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the cpntinued registration of your
product(s) containing this active ingredient(s). Within 90 days after you receive this Notice
you must respond as set forth in Section IE below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments
1 through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section DI-
B);or,
3. why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section DI-D). - . -"
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2. Data Call-in Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 4). ' - .
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
145
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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 five Attachments. The Notice itself contains
information and^instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section!
Section H
^ Section m'
Section IV
Section V
Section VI
Why You Are Receiving This Notice
Date Required By This Notice
Compliance Wiffi'Re^uiremeiiiis 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:
Attachment 1 -
Attachment 2 -
Attachments -
Attachment 4 -
Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status And Registrant's Response Form
List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
leevaluation identified additional date necessary to assess the health and safety of the continued
Hse of pjroducts containing this active ingredient(s). You have been sent this Notice because
' :^;:" : -you have iprbHuctiCs)'"contiaSing the subject active ingred"ie"nt:(s).
SECTION H. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The date required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
re required to submit the date of otherwise satisfy the date requirements
in Attachment 3, Regmremehy'Sta'tiis''^!! Registrant's Response Form.
within the time frames provided.
:! ;ป, , i III Ill iii I ii ,;.. " . . :j ,-(!,
*": ' I III I III I 146
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B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form.
within the time frames provided.
(
C. TESTING PROTOCOL ,
studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650). . _
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR ง
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 ง 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 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-
in Notice must be in accordance with Good Laboratory Practices [40 CFR Part
160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2)(E*) 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 CauVInfsX or any other agreements
entered into with the Agency pertaining to such prior Notice. Registrants must comply
with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend
their affected products. ,
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. , SCHEDULE FOR RESPONDING TO THE AGENCY
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The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days 'of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-
A and IV-B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
'--The options for responding to this Notice are: 1) voluntary cancellation, 2)
delete use(s), (3) claim generic data exemption, (4) agree to satisfy the data
requirements imposed by this Notice or (5) request a data waiver(s).
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A discussion of how to respond if you chose the Voluntary Cancellation option,
ie Deงe:iUse(s) option or the_ Generic Datajxemption option is presented below. A
s|on.of _&ง Carious ^ptions available for satisfying the data requirements of this
ys^cpjiimned in Section ffi-C. A discussion of options relating to requests for
|a|a yyaiyeis iง contained in Section in-D. ... .
There are two forms that accompany this Notice of which, depending upon your
:/:,;|esppnser6ne'or Agency/ These forms are
me Data-Call-in Response Form (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-in Response Form must be
submitted as part of every response to this Notice. Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response
Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have
questions or need assistance in preparing your response, call or write the contact
person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredienf(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a comp|ete(| pata; call-ln Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are
contained jfl Section IV-C.
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2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the
Requirements Status and Registrant's Response Form, a completed application
for amendment, a copy of your proposed amended labeling, and all other.
information required for processing the application. Use deletion is option
number 7 on the Requirements Status and Registrant's Response Form. You
must also complete a Data Call-in Response Form by signing the certification,
item number 8. Application forms for amending registrations may be obtained
from the Registration Support and Emergency Response Branch, Registration
Division, (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, must bear an
amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient(s). EPA has concluded, as an exercise
of its discretion, that it normally will not suspend the registration of a product
which Would qualify and continue to qualify for the generic data exemption in
section 3(c)(2)(D) of FIFRA. To qualify, all of the following requirements
must be met:
a. The. active ingredient(s) in your registered product must be
present solely because of incorporation of another registered product
which contains the subject active ingredient(s) and is purchased from a
source not connected with you; and, ,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula"' for each,of your products to which
this Notice applies. -
To apply for the Generic Data Exemption you must submit a completed
Data Call-in Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-in Response
Form. If you claim a generic data exemption you are not required to complete
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the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are
not in compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and
do submit the required data within the specified time. In such cases the Agency
generally will not grant a time extension for submitting the data.
C Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice., These options
are discussed in Section ni-C of this Notice and comprise options 1 through 6
on the Requirements Status and Registrant's Response Form and option 6b and
7 on the Data Call-in Response Form. If you choose option 6b or 7, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data
5. Request for Data Waivers. Data waivers are discussed in Section III-D
of this Notice and are covered by options 8 and 9 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must
sjibmit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
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C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data. Call-In Response Form that you agree to satisfy
gq^g^gj^" 0_e yoil ggjg^j. opgotl 65^d/ipfl7)",1'iiien 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, "Registrantr Response." The six options related to data
production are the first "six options" discussed under item]?1 in 'the instructions for
completing the Requirements Status and Registrant's Response Form. These six
options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
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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 in conformance
with Agency deadlines arid 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 beeii identified in
the Requirements Status and Registrant's Response Form and/or footnotes to the
form. If you wish to use a protocol which differs from the options discussed in
Section II-C of this Notice, you must submit a detailed description of the
proposed protocol and your reason for wishing to use it. The Agency may
choose to reject a protocol not specified in Section n-C. If the Agency rejects
your protocol you will be notified in writing, however, you should be aware
that rejection of a proposed protocol will not be a basis for extending the
deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will.be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratories) or
individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more
than 1 year, interim reports must be submitted at 12 month intervals from the
date you are required to commit to generate or otherwise address the
requirement for the study. In addition to the other information specified in the
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preceding paragraph, at a minimum, a brief description of current activity on
and the status of the study must be included as well as a full description of any
problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required
by this Notice and intend to seek additional time to meet the requirement(s),
you must submit a request to the Agency which includes: (1) a detailed
description of the expected difficulty and (2) a proposed schedule including
alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation
.from,the..laboratory performing the testing. While EPA is considering your
"request j"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 eyicjgngg...fflpy, be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not
specify all of the terms of the final arrangement between the parties or the
mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties
. lllฐMXSlffl2?,,lte,termง,,fif the agreement they may resolve their differences
through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development -
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If you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements of this
Notice and have been unsuccessful, you may request EPA (by selecting this
option), to exercise its discretion not to suspend your registration(s), although
you do not comply with the data submission requirements of this Notice, EPA
has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good
faith sought and continues to seek to enter into a joint data .development/cost
sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation
to the Agency proving that you have made an offer to another registrant (who
has an obligation to submit data) to share in the burden of. developing that data.
You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data. In addition,
you must demonstrate that the other registrant, to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a
copy of your offer and proof of the other registrant's receipt of that offer (such
as a certified mail receipt). Your offer must, in addition to anything else, offer
to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required
by this Notice by submitting a Data Call-In Response Form and a Requirements
Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data
as required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of ',
the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in
the specified time frame. In such cases, the Agency generally will not grant a
time extension for submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, .you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which
predate issuance of this Notice. Do not use this option if you are submitting
data to upgrade a study. (See Option 5).
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You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
a, You must certify at the time that the existing study is submitted
that the raw data and specimens from the study are available for audit
and review and you must identify where they are available. This must
be done in accdrdance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3(7) " raw data means any laboratory worksheets, records,
memprandaj notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event
that exact transcripts of raw data have been prepared (e.g., tapes which
have been transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be substituted for the
original source as raw data. Raw data may include photographs,
microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(7),
means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the existing study
that such GLP information is available for post-May 1984 studies by
',,//' ^ncljiding_an appropriate statement on or attached to the study signed by
m- "k " anaumorized'1 official or" representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria
for the Guideline relevant to the study provided in the FIFRA
Accelerated Reregistratipn Phase;J! 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
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protocols. If,you wish to submit the study, you must, in addition to
certifying that the purposes of the PAG are met by the study, clearly
articulate the rationale why you believe the study meets the purpose of
the PAG, including copies of any supporting information or data. It has
been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data
are usually not available for such studies.
If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above:
If EPA has previously reviewed a protocol for a study you are
* submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
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If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does contain
factual information regarding unreasonable adverse effects, you must
notify the Agency of such a study. If such a study is in the Agency's
files, you need only cite it along with the notification. If not in the
Agency's files, you must submit a summary and copies as required by
PR Notice 86-5. .
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and 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.
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Do not submit additional data for the purpose of upgrading a study
ฃlalsJfM ,SS,unacceptable and determined by the Agency as not capable of being
"upgraded.
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This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency.
You must provide the MRID number of the data submission as well as the
The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
yoiff ^pwssion 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.
i^
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
toncolo|vs studies generally wi|l have been .classified as ^' core-guideline" or
"core minimum. " For ecological effects studies, the classification generally
would be a rating of "core." For all other disciplines the classification would
be "acceptable." With respect to any studies for which you wish to select this
option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency ' s
^.classification of the study.
" ''' ' ' ' ' 1 '' " '
are citing a study of which you are not the original data
ifter, you must submit a completed copy of EPA Form 8570-31,
Certification with Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a
request for a low volume/minor; usewaiverand the second is a waiver request based on
your belief that the data requirement(s) are inapplicable and do not apply to your
product.
! Low Volume/Minor Use Waiver - Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
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pesticide registrants is small. 'In determining whether to grant alow volume,
minor use waiver the Agency will consider the extent, pattern arid volume of
use, the economic incentive to conduct the testing, the importance of the
pesticide, and the exposure and risk from use of the pesticide. If an active
. ingredient(s) is used for both high volume and low volume uses, a low volume
exemption will not be approved. If all uses of an active ingredient(s) are low
volume and the combined volumes for all uses are also low, then an exemption
may be granted, depending on review of other information outlined below. An
exemption will not be granted if any registrant of the active ingredient(s) elects
to conduct the testing. Any registrant receiving a low volume minor use waiver
must remain within the sales figures in Jheir forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a waiver, a
registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered '
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years.. Include information on raw
. material cost, direct labor cost, advertising, sales and marketing, and
any other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized
plant and equipment) charged to product(s) containing the active
ingredient(s) by year for the past five years. Exclude all non-recurring
costs that were directly related to the active ingredient(s), -such as costs
of initial registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
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separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to
fulfill each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of
company sales i^mdVand'dolErej1' of "the'active ingredient(s), direct
production costs of product(s) containing the active ingredient(s)
(following the parameters in item c above), indirect production costs of
produces) containing the active ingredient(s) (following the parameters
in item d above), and costs of data development pertaining to the active
ingredient(s).
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h. A description of the importance and unique benefits of the active
ingredient(s) tousers. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals, and
.,,,,.. ,,,:, , ME^^^&tii^&i&sfeS' Focus on benefits unique to the'active"
ingredient(s), providing information that is as quantitative as possible.
If you do not have quantitative data upon which to base your estimates,
then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active
ingredient(s) in terms of its benefits, you should provide information on
any of the following factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health
significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the
request for a waiver. .
2. Request for Waiver of Data -Option 9 on the Requirements Status and
Registrant's Response Form, this option may be used if you believe that a
particular data requirement should not apply because the corresponding use is
no longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
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You must also submit the current label(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy. -
You will be informed of the Agency's decision in writing. If the
Agency determines that the data requirements of this Notice do not apply to
your product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B), If EPA determines that the data are required for vour product^.
you must choose a method of meeting the requirements of this Notice within the
time frame provided fav this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements Status and
Registrant's Response Form indicating the option chosen.
IV- CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTTCF
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-
in Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1.
2.
3.
4.
5.
Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
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. "
Failure to submit on the required schedule an adequate progress report
on a study as required by this Notice.
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
159
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Ill III 111! Ill II I I I1 III I I |H 1 ill I I 11)11 II II 1 " . ' . , 'V
terms of an agreement or arbitration concerning joint data development
or failure to comply with any terms of a data waiver).
6, Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section ni-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
: ', *'i,: ';, , ' ,* ..... ( ~ซjjj ' ,-i ..... i- ..... c. .................. otherwise take appropriate steps to meet the requirements stated
". :; ill" ;.i? .' ซ-v ; ,*' i, ii'i ..... iซ! ( ' ^'''/(j'ji 'm^tt^'Noid.ce.i "unless ...... you" commit" 'to submit and do submit the'required
'' ..................... ........... " .......... ''' 1"""' ......... "" ....... '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.
n Fi! ! PHI ','",!': ....... !,, !' .' H ...... |,i!,| ' '!': "'!'' , , ',i,'ป ' * ......... '. ' ' 'P1 Pllll! ' 'll'i'li'ii'l ' I I'll I1 I ....... Ill I I ...... ill .......... Htm ill. 'ii '' '11 .......... I T ' ' 'P II ' "I1 ''' ..... I Till"! l 1 ||f |i| ' i ' |" 'i||||||i|| "||i" 'I .......... I ' ,,i " ' " . .' i
........ i
B. BASTS FOR DETERyI^^IQ^THAT SUBMITTED STtJDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet
any of the following :
1. EPA requirements specified in the Data Call-In Notice or other
documents incorporated by reference (including, as applicable, EPA Pesticide
Assessment Guidelines, Data Reporting Guidelines, and 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, selec^^ '
animals, sex and distnbSition "of' 'animals^ 36se arid effect levels to be tested or
attained, duration of test, and, as applicable, Good Laboratory Practices.
.''KiM^R ." ,,"ซ,;':
-------
c.
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.
EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants -of existing
stocks for a suspended registration when a section 3(c)(2)(B) data request is outstanding
would generally not be consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or use existing stocks of
suspended product(s) only in exceptional circumstances. If you believe such.
disposition of existing stocks of your product(s) which may be suspended for failure to
comply with this Notice should be permitted, you have the burden of clearly
. demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a
statement of the quantity of existing stocks and your estimate of the time required for
their sale, distribution, and use. Unless you meet this burden the Agency will not
consider any request pertaining to the continued sale, distribution, or use of your -
existing stocks after suspension.
w
. If, you request a voluntary cancellation of your product(s) as a, response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will
allow persons other than the registrant such as independent distributors, retailers and
end users to sell, distribute or use such existing stocks until the stocks are exhausted.
Any sale, distribution or use of stocks of voluntarily cancelled products containing an
active ingredient(s) for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to
sell, distribute, or use existing stocks beyond a year from the date the 90 day response
161
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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
Schedulgd to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith
manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or,the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person listed in Attachment 1, the Data Call-in Chemical Status
' '
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed natarCall-][n Response Form (Attachment 2) and
a complete3 Requirements Status and Registrant' s Response Form (Attachment 3) and any
other documents required by this Notice, and should be submitted to the contact person
identified in Attachment 1. If the voluntary cancellation or generic data exemption option is
chosen, only the Data Call-in Response Form need be submitted.
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
162
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2665 DATA CALL-IN CHEMICAL STATUS SHEET
i
INTRODUCTION , .
You have been sent this Generic Data Call-in Notice because you have product(s) .
containing thiobencarb.
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 reregistratiqn of
thiobencarb. 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 thiobencarb 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 2665 are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product chemistry data on thiobencarb are needed. These data
are needed to fully complete the reregistration of all eligible thiobencarb 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 Patrick Dobak at (703) 308-8180. .
All respohsades to this Notice for the generic data requirements should be submitted to:
Patrick Dobak, 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: Thiobencarb
163
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by
the registrant as appropriate Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency. ' ' . . ,
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107
Washington,'DC 20503. '
INSTRUCTIONS
Item L
Item 2.
ItemS.
Item 4.
Item 5.
This item identifies your company name, number and address.
This item identifies the ease number, ease name, EPA chemical number
and chemical name.
This item identifies the date and type of data call-in.
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.
Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of.
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
167
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Item 6a.
Item 6b.
Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item" 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-in Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-in Notice), and
incorporate that product into all your products, you may complete this item
for all products listed on this form If, however, you produce the active
j^g^g-ฃt yo^ggj^Oj use ฃ^y"unregistered" product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Check this Item if the .data call-in is a generic data call-in as indicated in
'jftem'3' and ff'ybu are" agreeing to'satisfy the "generic data requirements"of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates how
you will satisfy those requirements:
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
"' ;"'"' '' ' ' ' "'"" " '"requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding
":;:: : ': your response "
Item 11. Enter the phone number of your company contact.
168
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170
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
1 ' ' '
Generic Data
This form is designed to be used for. registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements. ' ;
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient. . .
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly. - .
Public reporting burden for .this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of, this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223'
U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and to the
Office of Management and Budget, Paperwork Reduction Project 2070-0107, Washington D C
20503. ' ' '
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2.
Item3.
Item 4.
Item 5.
This item identifies the case number, case name, EPA chemical number and
chemical name.
This item identifies the date arid type of data call-in.
* '
This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
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
171
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submitted in connection withthe 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 J.^QJ.Q^ ^^^ to-the gg^^gme]nts gt^s and Registrant's
Response Form.
Item 6.
$::.'!?
This item identifies the code associated with the use pattern of the pesticide. A
br,ief description of each code follows:
;ill j;>:''";"'ii&ftft'IS vm it ISi" IllKMSWiftR, *:ll':; lii'.:I SIM i:- :'.?''.;. , 'I ' ,, .. . : "' -:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N,
O.
Terrestrial food
Terrestrial, feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
|||, j|" y.iji, |,i T. , f, i , | ,, f , r, ,
M'"t' iiir Aquatic'non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item?.
This item identifies the ,cpde assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
End-Use Product
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP *
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure 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 ,
172
liiiiiin^^ i
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TEP/MET
. TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
- MET
IMP
; DEGR
*See: guideline comment
Typical End-Use Product and Metabolites
. Typical End-Use Product or. Pure Active Ingredient
and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
Degradates
Item 8.
Item 9.
This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-in Notice. ' . .
\
Enter the appropriate Response Code or. Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of these options.
1.
2.
3.
(Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
the conditions for submittal of this study as outlined in the Data Call-In
Notice and that I will provide the protocol and progress reports required in
item 5 above.
(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 CalHn
Notice.
(Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement'. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
173
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4.
1:11 M.
K'M .>.'.
5.
Ill
7.
8.
in in
III nil
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(Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option,
I certify that this study meets all the requirements pertaining to the
cdhoitions for submittal of existing data outlined in the Data Call-in Notice
,j', Ijpivil^ u'lil'l".!!!!!!":11" '^1 shil'''Pi,!' ''I1 ! i* !i ill I'll: IIJ,1" HI ..'I,'"1!"!,"!":,!! '"SI I'll'ITS!?! SSi'i-hl! HIT , , ,i , i" "ป':' ' t "' , , , ' ซ ' '. ^ , *''l ' ' 1" '
and I have attached the needed supporting information along with this
response.
(Upgrading a Study) I am submitting or citing 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.
(Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
(Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
(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 'minbf'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.
Item 10.
9. (Request for" Waiver of Data) I'have"read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the
Notice governs.
This item must be signed by an authorized representative of your company. The
person signing mustincmde his/her title, and must initial and date all other pages
of this form.
174
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Item 11.
Item 12.
Enter the date of signature.
Enter the name of the person EPA should contact with questions regarding your
response. , ' .
Item 13. Enter the phone number of your company contact.
175
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176
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178
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\
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTTCP.
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
.submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section ffl below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its '
Attachments 1 through 6; or
Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section ni-B); or
Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section lE-D).
If you do n9t 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
2.
3.
179
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your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in Response Form, as
as a list of all registrants who were sent this Notice (Attachment 6).
The ; authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
Information is authorized under the Paperwork Reduction Act by 6MB Approval No. 2070-
0107 and 2070:0057 (expkation date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
infonnation and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section IE - Compliance With R^guirem^ite Of This Notice
ii'T.. i'i^teS^^^^ ......... '.. ' '.
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
, ....................... .................... ........ Effects [[[ , ............................................ . ...................... .. ; ........
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - ..... 7 List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
SECTION! WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient arid reevaluated the
data needed to support continued registeation' of the subject" active ingredient. The' Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
-------
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the. studies
required in this Notice, additional testing may be required. t
H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-G. TESTING PROTOCOL '
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR ง 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 ง 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2)CB-) 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 ffl. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
ffl-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this-Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
.181
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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.
m-B. OPTIONS FOR RBSPONblNG TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section ni-C. A discussion of options
relating to requests for data waivers is contained in Section jjf.j)
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form, and the Requirements Status and Registrant's Response Form.
Attachment 2 and Attachment 3. The Data Call-in Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and
Registrants Response Form must be submitted for each product listed on the Data Call-in
Response Form unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response Form in
Attachment 2). Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
.; '^ปa|eletailed instructions on the response options. Dp not alter the printed material. If
you Have questions or need assistance in preparing your response, call or write the contact
J "-""" "s *""" -^ \ m'Attachment l".
1,1.1! li, I,, I"1::: ' nil, !
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in n n |. i nil"!" jTiiiii 'iii,'iiii'iii,; [uiinii.':;!1!::!,:,,,,!!!!!1 ^ .? m^,'. IF in iiiii'iS'iiiiiiiHiiiii',1:',!!'!;"!!,'!',!,,,, ii"iP!i: j-BNiiiiJ!'1'' \v Misi/h ni'iiniiif1!'1",!*!!!1!1!!!'! "iUhJiiiiiiii; :i:"'iiii
1 . Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is the
libject of this Notice. If you wish to voluntarily cancel your product, you must submit a
(!omj^leted Data Call-In Response Form, indicating your election of this option. Voluntary
q numbef ฃ- --- ^ ]pata Cali-5i Response ponฃ "if you choose this option,
this is the only form that you are required to complete.
|f 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.
iiiiiiLi'i i i>< ,1',' '''.''r ' iillilll i I ' I ii mi 1 1 i ll ill i mi nil I i i i 'I liiii I 'I i ill i 1111111 I . ... ':' "' ... ,- "
2v Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice.. These options
^^is^^ui.^iti.o^jnt.Q ...... of .this ....... Notice,,, and ..... comprise options 1 through 6 on the
RejpkemeMsJStatus and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
liiii ....... ;!" i, aii'i:
. v ..... mil
182
If;;;1 i,,,
-------
3. Request for Product Specific Data Wflivars. Waivers for product specific data are '
discussed in Section IH-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen to address the
data requirement. ,
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTTCF
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or'7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide registrants to additional instructions provided in this Section. The
options are: , , '
(1) I will generate and submit data within the specified time frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) , I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and 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 in
confprmance 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-
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports. The
noted deadlines run from the date of the receipt of this Notice by the registrant. If the data are
not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements (s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
' . ' . . 183
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schedule including alternative dates for meeting such requirements on a step-by-step basis.
You 'must explain 'any| techrucal'oflaboratory difficulties and provide documentation from the
laboratory"peHormuig'tHe testing. While T3? A 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 - Registrants may only choose
this option for acute toxicity data and certainefficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data" If this is the "case"" data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
"final aj^^ggj^gnf. Jietween'ffie parHes'of the mechanism to resolve the terms. Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may
resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development - This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or ^^nd ^ 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 whb lias" in good faith sought and continues to seek to enter into a joint
data development/cost sharing program, but the other registrant(s) developing the data has
refused to accept your offer. To qualify for this option, you must submit documentation to the
Agency proving that you have made an offer to another registrant (who has an obligation to
submit data) to share ."In tfie g^en bl'developihg'tfiat 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 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 fejgis'traiit "must also inform EPA of its election of an option to develop
arid submit the data required by this Notice by submitting a Data Call-in Response Form and a
184
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Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice. '
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4, Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate issuance of,
this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
/ ' . '
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated. .
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met: , . '
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 16Q.3(j) " 'raw data1 means any laboratory
- worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
; or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3(k), means "any material derived from a test system for examination or
analysis." v
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
185
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submitting Sie 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
FesEcide 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
te PAG are met by the study, clearly articulate the rationale why you believe
I I I'Sli1!!1!,,"1!!!1!""!!'!!! ;i!"" "n... in :'. i, ," *i a ปL _vป " ""is1 r "' S"" 'i J'S A
e study meets the purpose of the PAG, including copies of any supporting
mformation or data. It has been the Agency's experience that studies completed
prior to January1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
Till 11 I ill, Jil , i , n i f ,,i i , , . .
If you submit an existing study, you must certify that the study meets all requirements
Of the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a s^^^y ^^ c5pies as requires by' PR i^o'So" e 8 6-5.
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 requkement 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: ^5 npte fEafriot all s^ies 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 confbrmance 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.
186
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This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6,-Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA,xthat study must have been previously classified by EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum."
For all other disciplines the classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
m-D REQUESTS FOR DATA WATVRRS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete-justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be
the only, opportunity to state the reasons or provide information in support of your request. If
the Agency approves your waiver request, you will not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
Agency would grant a waiver only under extraordinary circumstances. You should also be
aware that submitting a waiver request will not automatically extend the due date for the study
in question. Waiver requests submitted without adequate supporting rationale will be denied.
and the original due date will remain in force.
f
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
187
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IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
io failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FEFRA 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:
Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
I.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure ttoi submiton the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to 'suSmissibn"ofciStlbnoT existing studies or offers,
arrangements^ or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver)'. ' , ,
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section HL-C of this Notice.
ii i i "tii i11'!,; JEM.'" (jSJiVi;1/ i!,;:;;!1 jt'jii ; lie l,tm i> wiim- in si i WM: it- it i;;"ซ. ; ', i' '; v - , < s '".;"
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
Ojf jdeveioging data and provided proof of the registrant1 s receipt' of such offer or
failure of a regis&ant on wliom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in
the specified time frame.
188
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9. Failure to take any required or appropriate steps, not mentioned above at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT STTR1UTTTT?r> STUDY TS
UNACCEPTABLE' ~" ~
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-in Notice or other documents
mcorporated 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.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCP.LLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be^
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is putstanding would generally
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your productfs)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA .that granting such permission would be consistent
with the Act. You must also explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
189
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If you request a voluntary c^celiafibn'ofybuf product(s)"as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
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
deirjohstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For exafnple, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information"necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA will
consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-in Chemical Status
190
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-Tn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be
submitted to the contact ,person(s) identified in Attachment 1. If the voluntary cancellation or
generic data exemption option is chosen, only the Data Call-in Response Form need be
submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice. ,
Sincerely yours,
Lois A. Rossi, Director
'Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Pat;
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential -Statp.me
Formula Form
191
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I'!FI;I (IP1:; :,! 3 !K , IIIH i,"
./>. ', i; ;< is.;!; ifi'fE;!1 M!:", .1 11-i:. -Ii'i'/ii'i'S"!:;-:".'c-i1,;;!Kliin''.' ป,;:if'i i-'iiii',.;;vi?.s,in- IB cj;'
H |il,| '",,!''!" H! ',,'iii!.,,,! ''it1 , i lii,! IE'i1,.:,!!1 i1,,,.''!, ,, J .l
192
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THIOBENCARB DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION , '
You have been sent this Product Specific Data Call-in Notice because you have productfs)
containing thiobencarb. .
. 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 reregistration of
thiobencarb. 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 Hst of registrants receiving this DCI (Attachment 6) and
(7) the Cost Share and Data Compensation Forms in replying to this 2665 Product Specific Data
Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTTCR
The additional data requirements needed to complete the database for 2665 are contained
*? ฑe Requirements Status and Registrant's Response Attachment 3. The Agency has concluded
that additional data on 2665 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 2665 products.
INQUIRIES AND RESPONSES TO THIS NOTTCR
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact CP Moran at (703) 308-8590.
All responses to this Notice for the Product Specific data requirements should be submitted
to: . .
CP Moran
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: 2665
193
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT ^SPECmC DATA
Item 1-4. Already completed by EPA.
,t
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-in Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-in Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data exemption,
you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide
the EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such
products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
Item 7a, For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
^l iiipi!' ! I-1" .' , i. ';: i;, i.;,,. '; ,,n, i " ' ' iniliiiQiliii f i' '"iii1,,,.':, ป, ,,ป' i;,,;, f i, j 4i!' ;i;!' I,'1' Til1 iiJ ฐ.i i HI, '!''", " i',:!!1'"' i ii1 Mil .i!!!ll t1 i !> 1,,' ft is I ''"Si* ::! [ '"'.'"'i1''" i: I ffl!,!:' "V> '^ H* if ill'i:'ซ' i, : ''fcii; if* B i'',",' : ป' "il' . ':"'" i'."" i;> , ? ' . h , ' , ,' ' '
ItenYTb.
For each end use product (EUP) for which you wish to maintain registration, you
:.musf 'M^^*^"^ ^e" d"*^ requirehiientis' by responding "yes." If you are
.^questing1 a data"waiver" answer ""'yes1" nere; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
iilhililllllilh' .rfM.'lillliJilil'"!!!'''!!!1: ' 'I, hil. '!', ' f1,1 ii' i ' 'll .' ' r ' Iii ' '^ !' :'i I '
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
196
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Item 1-3
Item 4.
^TC. :FOR COMpLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3 This number must be used in the transmittal document for any data
submissions in response to this Data Gall-In Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
STSStSS?IJ1^^0^^ CฐMuCt <*?ป ^nired ^ies.
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
t
The study title associated, with the guideline reference number is identified.
The use patternฎ of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns
are covered by the data requirements. In the case of efficacy data, the required
studies only pertain to products which have the use sites and/or pests indicated.
-The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Enter only one of the following response codes for each data rPT,^0^ to
show how you intend to comply with the data requirements listed in this table
duller descriptions of each option are contained in the Data Call-in Notice.
I will generate and submit data by the specified due date (Developing Data) Bv
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data^ Call-in Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4) .
I have entered into an agreement with one or more registrants to develop data
Jr?v( CostSharmง)- l am submitting a copy of this agreement, I understand
lhat this option is available only for acute toxicity or certain efficacy data and only
if.EPAuidicates 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 By the
specified due date, I will also submit: (1) a completed "Certification With
201
-------
HI;- i :;(!
i It it ,1)1 ''
nil i in i ii i i ii i i i , in ill n i II I __ '/'.i-i'." ..... ia '
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
'(EPA ..... Form 8570-4) . \ ..... '~"_ '"' """ ' ..... ' ...... " ^ ..... ; "' ...... [ ..... " "~ "'__ ..... " ^ "' ' .....
^
1 *.**ซ' ..... .S;'1-:,
I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am inducting a copy of my offer and proof of the other registrant' s receipt
o'f mat offer. "1 "am i^u^^'i^pa^'whidi is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section ni-C.l.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
^ '.l-'.'gy'^'^^^j^^ submit an"" existing'study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
f cerHfy Sat this suidy will meet all the requirements for submittal of existing data
Outlined in Option 4 in the Data Call-In Notice (Section HI-C. 1.) and will meet the
Ittached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
"that I 'Haveae"terminedmat this study will fill the data requirement for which I have
indicated this choice. By the specified due date, I will also submit a completed
"CeS^SK^^I^St^oData CompensationRequirements" form (EPA
Form 8570-29) to show what data compensation option I have chosen. By the
specified due date, I wM also submit:'. (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two c0mpieted and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I will
Submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this
option outlined Option 5 in the Data Call-In Notice (Section DI-C.l.) apply. By
the specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
6. By the specified due date, I will cite an existing study that the Agency has
^V""ijf Classified as acceptable or an existing study that has been submitted but not
,202
-------
7.
r,Z ? I*^e Agency (Citmg an Existing Study). If I am citing another
registrant s study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option^if I am citing my own data. In either case, I will provide the MRTO or
Accession numberฎ for the cited data on a "Product Specific Data Report" form
or in a similar format.' By the specified due date, I will also submit" (1) a
completed "Cerfafication With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a Complete justification for this request
including technical reasons, data and references to relevant EPA regulations'
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant-s Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a
completed "Cerfafication With Respect To Data Compensation Requirements"
^T 857ฐ>9) ^ (2) ^ comPle
-------
TRB'S BATCHING OF PRODUCTS CONTAINING THIOBENCARB AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
i
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
Thibencarb (S-((4~Chlorophenyl)methyl) N,N-diethylthiocarbamate) 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
lid biological activity), product form (liquid, paste, solid, etc.), and labeling (e.g., signal word,
precautionary labeling, etc.).
Using available iiiformation7 batching nag been accompHshed by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch.
Registrants have the option of participating with all or some other registrants of products in theix
product's batch, to deal only their own products within a batch, or to generate all the required
acute toxicological studies for each of their own products. If a registrant chooses to generate the
data for a batch, he or 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 or she may do so
provided that the data base is complete and valid by today's standards (see the attached acceptance
criteria), the formulation tested is considered by EPA to be similar for acute toxicity, and Hie
formulation has not been significantly altered since submission and acceptance of the acute toxicity
; mav not support their product using data conducted on a product from a. different
data, R
batch! TR1B
III I H ,,'H H, " i; U'INL 'i" 'ป i,,i
not support their product
' anv new of caffffeled formnlations (that were presented to the Agency
UL,ii.^ป.. of the RED1 before data derived from them can be nsp.H tn cover other
,.,wป^i.. a batch. Regardless of whether new data is generated or existing data is referenced,
registrants mu^Tde"arlv identify the test material bv 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.
I I 11111 I I II Illl III II I I | I I I II III I III I III Illl 1 I II III II I III I I I ,"' \ i ' , , ' y ' ' ป'>! < iil"'i'1 !. ,
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 or
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 or 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 or she must
choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing
Study (Option 6). ff a"reglsttaiit"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
204
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(Option 3) those studies.
Table 1 displays the products that were batched.
Table 1.
* "" batth fr0m-cWn8 or her ซ"* aud offering to cost share
Batch
1
2
Registration Number
59639-79
. _
63588-6
59639-80
63588-5
Percent Active Ingredient
Thiobencarb 84%
Thibencarb 34%
Thibencarb ...10%
.
Thiobencarb 10%
_ .
Form
liquid
liquid
solid
' ,
solid
Table 2 displays the product that was not batched. The registrant is responsible for submittine
SiS3* t0, ^r ?S Pr0dUCt' The Te^nical Review Branch wiU not accepfrSewf
submitted on any of the batched products to support the one "No Batch" product.
Table 2.
63588-4
Percent Active Ingredient
Thiobencarb
...97.4%
205
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206
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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
fippies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c< The CSF must be signed, dated and the telephone number of the responsible party
: :: : ' ' ' must be provided!
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. .JsJii'wsigfas^ 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
! ....
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. 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.
j. 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 mix 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 aU 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.
, 208
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210
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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
anagement and Budget, Paperwork Reduction '
ease fill in blanks below:
Impany Namo
bduct Name
lertify that:
Company Number
EPA Reg. No.
S
lature of Company's Authorized Representative
le and Title (Please Type or Print)
=orm 8570-32 (5/91) Replaces EPA form 8580 which is obselete
Date
211
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212
-------
United States Environmental Protection Agency
.Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2O70-O107,
2070-0057
Approval Expires
3-31-99
lublic reporting burden for this collection of information is estimated to average 15 minutes per response including timp for
^^^
suggestions for reducing this burden to, Chief Information Policy Branch PM-233 u S '
[lease fill in blanks below.
lompany Name
roduct Name
Certify that:
Company Number
EPA Reg. No.
'
That for each study cited in support of registration or reregistration under FIFRAthat is NOT an exclusivp UQ* <**,,*, i * th
the attached
gnature
une and Title (Please Type or Print)
Date
to pay compensation to other persons, with regard to the registration or
FIFRA section 3(c)(1)(F) and 3(c)(2)(D). , ..:
gnature
arne and Title (Please Type or Print)
Form 8570-31 (4-96)
213
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Ulii
214
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The following is a list of available documents for thiobencarb that may 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 Adobeฎ 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
CP Moran at (703)-308-8590.
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 2665.
The following documents are part of the Administrative, Record for 2665 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
215
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216
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