United States Prevention, Pesticides EPA 73ฃ"R.98-011
Environmental Protection And Toxic Substances October 1998
Agency (7508C) __________ ___
Reregistration
Eligibility Decision (RED)
Triclopyr
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United States
Environmental Protection
Agency : - -
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-98-007
October1998
R.E.D. FACTS
TRICLOPYR
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
poshig unreasonable risks to people or the environment Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards. .
Under the Food Quality Protection Act of 1996, EPA must consider the
increased susceptibility of infants and children to pesticide residues in food, as
well as aggregate exposure of the public to pesticide residues from all sources,
and the cumulative effects of pesticides and other compounds with a common
mechanism of toxicity m establishing or reassessing tolerances.
In evaluating pesticides for reregistratioh, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects 6f each pesticide. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard
of the FQPA and can be used without posing unreasonable risks to human
health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
2710, that includes triclopyr acid, triclopyr triethylamine salt (TEA) and '
triclopyr butoxyethyl ester (BEE).
Triclopyr TEA and BEE products are used as selective herbicides to
control broad leaf weeds and brush on a variety of sites- rights-of-way,
pasture and rangelands, forests, rice, and turf, including home lawns. Triclopyr
products are formulated as soluble concentrates, emulsifiable concentrates,
liquids (pressurized and ready-to-use), granulars, wettable powders and pellets.
' ' ' . " ' " - , - f
Triclopyr TEA was first registered in 1979 as an herbicide on non-crop
areas and in forestry use for the control of broadleaf weeds and woody plants.
Triclopyr BEE was subsequently registered in 1980 for use on the same sites.
Both formulations were registered for use on turf sites in 1984. In 1985,
triclopyr BEE was registered for use on rangeland and permanent grass
pastures. Most recently (1995), triclopyr TEA was registered for use on rice
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to control broadleaf weed species. A Data Call-In Notice (DCI) was issued in
August 1991 requiring the submission of product chemistry, residue chemistry,
i ecological and environmental fate data for both TEA and BEE and
tpxicplpgical data for TEA. At the time of the RED assessments, there were
,i'2 rSli?teredproducts containing triclopyr BEE and 24 products containing
triclopyr TEA.
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Toxicity
Technical triclopyr acid was found to be slightly toxic by oral and dermal
routes and has been placed in Toxicity Category III for these effects.
Acceptable studies for acute inhalation, primary eye irritation, primary dermal
irritation and dermal sensitization were not available for the technical grade of
triclopyr acid. Available data indicate that both BEE and TEA are slightly
|y oral (Toxicity Category III) and^^ dermal (Toxicity Category III) routes
ซS of exposure^ and practically non-toxic by inhalation (Toxicity Category IV) and
l! ;?;:*!?iFaulฎ 'i^^^^^^.^.^]^?^ eye ^ta^c>Jl snidy triclopyr TEA
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; iiiiiL caus'e, d,eSP?^ s^i|^tion jjn test animals.
ii'111!' &'."; li'fhe. Agency has classified triclopyr as a Group D chemical (not'
;;;i]S This decision was based on increases,
:, ~ rat and mouse, and adrenal
i:;ii|| pj^octopmocytomas in the male rat, rwMch were considered to, be only a
marginal response, and the absence of additipn4 support from structural
analogs or genotoxiciry.
r The Reference Dose (RfD), the amount of triclopyr residues that could
be consumed daily over a lifetime without adverse effects, was established at
0.05 mg/kg/day, based on the 2:generation reproduction toxicity study in rats
with a NOEL of 5.0 mg/kg/day, the lowest; dose tested. At the next dose level
(25 mg/kg/day), an increased incidence of proximal tubular degeneration of the
kidneys was observed in PI and P2 parental rats in this study.
For the acute dietary risk assessment, the endpoint of concern was the
maternal and deveippmental NOEL of 30 mg/kg/day from a developmental
toxicity study in rabbits based on a decreased number of live fetuses and other
effects at the 100 mg/kg dose.
Becatlse( feliable pre" and Post-natal data indicate no special sensitivity of
young animals to triclopyr residues, EPA finds that an uncertainty factor of
100 (10 for interspecies differences in response, and 10 for intraspecies
differences) is adequately protective of infants and children. Therefore, for risk
assessment purposes the" c^
100, and the acute dietary risk assessments assume that a margin of exposure
(MOE) of 100 or greater is acceptable.
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Dietary Exposure/Risk
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People may be exposed to residues of triclopyr through the diet.
Triclopyr tolerances have been established for grass.forage and hay, meat, meat
byproducts, milk and eggs, and rice. EPA's tolerance reassessment indicates
only minor changes to the current tolerance expression and tolerance values
are needed, provided the label restrictions required by this RED are
implemented limiting grazing and application rates.
Calculations: using existing rriclopyr tolerances result in a, TMRC
(theoretical maximum residue contribution) which represents < 1% ofthe RfD
for the general population and < 3% of the RfD for children less than one year
old, considering food only. These small percentages of the RfD generally
indicate little concern.for dietary risk.
Chronic aggregate dietary risk estimates, including both food and an
upper bound estimate oฃ triclopyr residues in drinking water, account for 16%
of the RfD for females 13+ years, and 49% of the RfD for children ages 1 to 6.
The acute dietary (food only) MOE for the most sensitive subgroup,
females of child bearing age, is 2500. The acute aggregate dietary MOE for
the sub-population of greatest concern (pregnant females 13+) including food
and drinking water is 1250.
Both triclopyr and the insecticide chlorpyrifos produce the metabolite
3,5,6-trichloro-2-pyridinol (TCP). TCP is similar in toxicity to triclopyr and
less toxic than chlorpyrifos. EPA's aggregate assessment of the known, likely
sources of exposure to TCP from both triclopyr and chlorpyrifos uses results in
an acute MOE of 600 for females 13 + years. Aggregate chronic exposures
could account for up to 90% of the provisional RfD for TCP for non-nursing - .-
infants less than; 1 year old. Because these estimates include many upper
bound exposure assumptions and still fall within acceptable limits, EPA
believes that the risks posed by dietary exposure to tibie metabolite TCP are not
of concern. .
Occupational and Residential Exposure/Risk
<-> Dermal absorption is calculated to be < 2% based on a study with human
volunteers and a rabbit dermal absorption study. Neither occupational nor
residential risk assessments for short-term and intermediate-term dermal
exposure to triclopyr have been conducted because no adverse effects were
seen at the highest dose tested of 1000 mg/kg/day in a 21-day, dermal toxicity
study in rabbits.
Because the acute .inhalation LC50 was determined to be > 2.6 mg/L,
significant toxicity resulting from inhalation exposure would not be expected,
and a separate risk assessment for the inhalation route of exposure is not .
warranted.
Homeowner exposure to triclopyr is expected to be minimal because of
low dermal and inhalation toxicity, and because methods typically used by
homeowners do not provide significant exposure (e.g., weed stick), and
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. insize. 'Also, the percent active ingredient
^ ฐf korafSwnfr products are less than those for
agricultural or industrial use products. No chronic residential or occupational
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Reliable data indicate no special sensitivity of infants and children to
: triclopyr residues. An uncertainty factor of 100 has been applied in both the
, cjiromc 9nd.acute dietary risk^ assessrrients. Both acute and chronic aggregate-
dietary (food + drinking water) risks are well within the acceptable range for
^^^^^^^ ^ a metabolite common to both
II!' S;'!'''1'."1; v' !1::;" 'l:li';l|Sc|oj^riand chlorpyrifbs. EPA has not made a final determination regarding a
"5*""::., ',;':':". :';"'.'; '^,f!ฐ^*lฎ .PฐiS??i S^asi81^ ฐf toxicity for triclopyr and other substances or
sif ซ'.. -.;;.' ::: / .ss^l^H;!0;;!^^!^ For the purposes
::;: :,;:,":; :;;::'' E ^l^6, toleiasce rcassessmeirt^m.ti^s.IOT, EPA considered only the. risks of
triclopyr and TCP in its assessments.
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'.T^<^ฐPyr ^.^ somewhat persistent, and is mobile. The predominant
degradation pathway for triclopyr in water is photodegradation. The
Predominant degradati ra paiiway in soil is microbial degradation to the major
degradate TCP, which is both persistent and mobile.
Triclppyr acid was found to be slightly toxic to birds and practically non-
toxic to mammals, insects, freshwater fish ^ and invertebrates. Triclopyr TEA
wasPrac%Srwn^o^ to birds and estuarine/marine
| mvertebrates and practically non-toxic to freshwater fish, freshwater
invertebrates and estuarine/marine fish. Testing with BEE indicated it to be
s^g^ tox!c IS birds, moderately toxic to highly toxic to freshwater fish and
estuarine/marine invertebrates, slightly to moderately toxic to freshwater
mvertebrates, and highly toxic to estuarine/marine fisli.
Using current maximum permissible application rates (i.e., up to 12. 12
Ss/ae/A), levels of concern (LOE) are exceeded for many species. However,
calculating RQs at the revised, lower maximum rates established by the RED'
^ !; iSfflfe^^UWly chronic risk to mammals, acute risk to fish (BEE) and acute
risk to npn:target plants remain problematical.
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Factors that lessen the Agency's concern for these LOG exceedances
include several worst-case exposure assumptions that are unlikely under actual
use conditions. For example: The screening level chronic assessment is based
on 0-hour residues and does not take into account degradationactual
environmental concentrations would be less. Acute risks to fish were
calculated assuming direct application to shallow aquatic habitat, which is not
currently allowedflowjng water systems would result in rapid dissipation of
uiclopyr. Because triclopyr is an herbicide, risk to non-target plants is
anticipated. However, potential damage to non-targets will be minimized by
new spray drift management requirements and reduced application rates. Also,
the'-fegistrant, Dow Agrosciences (formerly DowElanco), has provided the
Agency with survey data indicating that typical application rates range from 0.5
to 4 Ibs ae/A, generally much lower than the maximum rates allowed by current
labels, and that more than 95% of triclopyr applications occur only once a year
or less frequently.
EPA is concerned about the potential chronic toxicity and persistence of
the triclopyr degradate, TCP, in the aquatic environment and is requiring
additional confirmatory data to better characterize the fate of TCP and its
chronic toxicity to fish, particularly salmonid species.
Risk Mitigation Measures
In order to reduce risk to non-target plants and animals, pesticide
handlers and the environment, EPA is requiring the following changes to
triclopyr use practices and labeling:
. ' . . ' -.--.' ;./..
The maximum application rate permitted on pasture and rangeland and all
other sites where cattle can be grazed will be 1 Ib/ae/A per year; for .forestry
applications the maximum will be 6, Ibs/ae/A; for all other sites the maximum
allowed rate will be 8 Ib ae/A for the BEE and 9 Ib/ae/A for the TEA.
Labels must include best management practices for spray drift.
A label statement warning users of the potential of triclopyr to leach to
ground water in certain situations is required.
A restriction against grazing lactating dairy animals until the following
season is required. All conflicting grazing instructions must be removed.
Labels must specify a 14 day PHI for grass hay, and retain the existing pre-
slaughter interval of 3 days.
An REI of 48 hours for triclopyr TEA, and 12 hours for triclopyr BEE is
established for uses within the scope of the Worker Protection Standard; early
entry PPE consisting of coveralls, chemical resistant gloves> protective
eyewearfor TEA formulations, and shoes+sox) is required. '
Homeowner reentry is restricted until sprays have dried'and dusts have
settled. "'...' ,
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For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides telecommunications Network (NPTN). Call toll-free 1-
, 800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time, Monday
through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' ' '''' ' '' ' '
WASHINGTON, D.C. 20460 '.'-
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MATT.
': ' ' . ,;' OCT 2.1 1898
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistratidn eligibility review and decisions on the pesticide chemical case triclopyr which
includes the active ingredients triclopyr acid, triclopyr triethylamine salt and triclopyr butoxyethyl
ester. The enclosed Reregistration Eligibility Decision (RED), which was approved on September
30, 1997, contains the Agency's evaluation of the data base of these.chemicals, its conclusions
regarding the potential human health and environmental risks of the current product uses, and its
decisions and conditions under which these uses and products will be eligible for reregistration.
, The RED includes the data and labeling requirements for products for reregistration. It also
includes requirements for additional generic data oh triclopyr to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the date of your
receipt of this letter. The second set of required responses is due 8 months from the date of
your receipt of this letter. Complete and timely responses will avoid the Agency taking the
.enforcement action of suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both the pesticide law (FIFRA) and the food and drug law
(EFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-^case basis and will not bind EPA as it proceeds with further policy . -
development and any rulemaking that may be required.
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If EPA determines, as a result of this later implementation process, that any of the
deienninations described in (this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this '
8355."
s * iv ra1 iv:,.. ฐn tne product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative C.P. Moran
at (703) 308-8590. Address any questions on required generic data to the Special Review and
l-';;^!: ;ฃ i!;".^?8Jstration Division representative Dean Monos at (703) 308-8074.
' r-4 ;-' :fฅ' "' Enclosures
Sincerely yours,
Loi^ A: Rossi., Director
Special Review and
nstration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION
1. DATA CALL-IN (PCD OR "90-DAY RESPONSE" -If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic' and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and. have been
granted a generic data exemption (GDE) by EPA, you are being, sent only the product specific
, response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time, extension requests
will be granted for the 90-day response. Time extension, requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data Waivers must be submitted as part of the.
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE 'V-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. 'Five copies of draft labeling which complies with the RED and current regulations .
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may? but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling [
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, 'August 1992" (available from the National Technical
Information Service, publication #PB 92-221 8 11; telephone number 703-605-6000).
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRJD) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI). . .
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must.
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
ง158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
W^'l'il .; (?^!^!?^8P:^^fflF^i^^^!3^ Jn 19 C?R. ง158.175(e). A copy of the CSF is enclosed;
ir^$'^ ,
1 ' ' '' *t:'t '' '' | J'"/'e:i;;gertification With Respect to Citation of Data and Data Matrix Complete and
Sign EPA forms 8570-3"4 arid 8570-35 for each product.
i I ''ill, ' ' "Sill1!!1" i ' L'ii " nil!!',! ; ' , ,<" , . iir , , ",, " ,,i ' ,1 ',,', i
OffiftjPWENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Commints'
pertaining to the content of the RED may be submitted to the address shown in the Federal
^_._ ^^ ;.;;.Register Notice which" announces 'the availability "of'this RRD
S.~WJ3TERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY^ AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES^
Bv U.S. Mail:
I';11'1/!,;''' lll'ilil'i i i i i i i ! ,;'; ..,' ';'-, ::V;: :f Y,;^
D'ocument Processing Desk (RED-SRRD-PRB)
!i% ;;
iiI"!"'-Washington, D.C. 20460-0001
=,=:: I ::,::':/ ''; = ;, By^eXpreSS;
,': f " ^ ' ' '
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C) '.
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
aiii iiiiiitiiiiviisa is i'ป- :,,,6, EPA'S RE VIEWSEPA will screen all submissions for completeness; those which are not
Illl |^ ^,j|. ^ p^|j|jg|e w^j j^e renirned with a request for corrections." ^EPA will try to respond to data waiver
IZ^:.^^;1;, i- ';,?ni firQe,,,e:xtgnsion requests within 60 days.' EPA will'also try to respond to all 8-month
111. If Ilil" ,,| 'ill'in- 111 !,' ' -/ ' J i :.::.'.''.." 'i i", ' " ft * " " ' ' '" ^ " *
~" wjth a, final reregistration determination within14 months after the RED has been
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REREGISTRATION ELIGIBILITY DECISION
TRICLOPYR
LISTB
' '.. . CASE 2710 -;'. .
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TABLE OF CONTENTS
* ''',' I ' :" '.-'..'. - ' '
TRICLOPYRREREGISTRATION ELIGIBILITY DECISION TEAM . . ....... . i
* - . ABSTRACT. ...... ......:........... I...,:..;..v
,'. I. INTRODUCTION...'. :..'.-.':.'.. . .r.. .'.. ....... :.; ... . ..,...:,....;..:....;.. 1
'' - " n. CASE OVERVIEW .. ...*."..:...... ..._.,._.:'.. .v.. .....],.'.,. '.2
A* Chemical Overview . . . . . .... . ... . ; v2
B. Use Profile ...:.. ....:.....,;.,. :.............. 3
C. Estimated Usage of Pesticide . .... ^.......:.........,.....;..., 4
D. Data Requirements 4
E. Regulatory History ........; ............>../....... 4
,. m. SCIENCE ASSESSMENT-. ........... . ,. ., .'. ...'.... .'. .,. . . . ... . ...'. 5
A. Physical Chemistry Assessment .',... ,.'. ..... 5
B. Human Health Assessment ........ . . .'.' . . . . . . . ... 5
1. Toxicology Assessment . . . . . 5
a. .'Acute Toxicity ........... .....'........:.....,./....,: 6
b. Subchronic Toxicity ..: :..... 8
c. Chronic Toxicity ... . . . . . 8
d. Chronic Toxicity/Carcinogenicity 10
e. Developmental Toxicity .......... .^ 11
f. Reproductive Toxicity ."',. . 13
: . g. Mutagen.icity .........-......:....... ... \ . ... : . 14_
h. Metabolism . . . ; . ...... 15
2., Dose Response Assessment . . 16
a. Reference D,ose ... .... ...:.... 16
b. Dermal Absorption .......; 16
* c. Other Toxicological Endpoints 17
d. , Cancer Classification 18
3. Exposure Assessment . . ... . ;-:... 18
a. Dietary Exposure . ............:....... 18
b. Dietary Exposure from Drinking Water ...... 22
" c. Occupational Exposure .;.,.. .... ..'...,..:... 23
4. Risk Characterization 26
a. Dietary Risk .:...... 26
b. Drinking Water Risk .27
<,',. .'.;' c. Occupational Risk . .... '.'-. . . . . . . ', 28
d. FQPA Considerations 29
' C. Environmental Assessment . . .................. 35
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I 111 111 I I III II I I I III , . '. -.-.'
1. Ecological Toxicity Data 35
a. Toxicity to Terrestrial Animals . . . . .,.,...,.' .35
b. Toxicity to Aquatic Animals 39
2. Aquatic .48
3. Environmental Fate . . ; 50
a. Environmental Fate Assessment 50
b. Environmental Fate and Transport 53
;,Cd. , Wa|er jfesources ,.,,. .,, .. .... ,.,.,,...,._ V 61
4. Exposure and Risk Characterization ; 69
a. Ecological Exposure and Risk Characterization 69
b. Environmental Risk Characterization 98
F?. ...RISKMANAGEMENT AND REREGISTRATION DECISION 107
A. Determination of Eligibility . . 107
B, Determination of Eligibility Decision 107
~':' : "-1"" : L Eligibility Decision ' 107
.- i" :,'' \'::. .";:;;::2.,. ^Eligible and Ineligible Uses 108
1 ........... ........ ' ........ ' ........ iilil!l ..... "
.. , .
ml ...... ii'i"^ ' i""cr''lt , ...... ....... ,Food Quality Protection Act Findings ............. 109
,|i;!l;;;J;:S:'^!2.'^; Tolerance Reassessment ...... ",".".'.'.' Z... /, ....... ..... ..,..-.., ....... 112
="~'':,:: --=" '.."" 'T3. ............. Benefits from Use of Triclopyr . .' . . '.". . . .;'.' .'.'.". . '.''. . .'. ......... 114
: m ฃ ;> . ;' :'; =4> ................. . . Ecolpgical Risk Mitigation . ' ............................... 114
'"I ' ''';i.-. , ' 5. ........ Ground Water ............... - ............ ', ...... . ........ 117
S:;,;,11 ;:,' ;. ';';;, 6, L ..... ......... ..... Occupational Labeling Rationale .............. ' ......... , ... 117
ปli > ........ - ": --''7. Endangered Species Statement ....... '...-. ....... ,.::..... ...... 121
ซili-v, 'i,.'.'1 !:I'S. ........................ Spray Drift ..... Management" . '.".'. . ..'.'.". . ." . . ..... . . . ."' .......... ". ..... 122
........... .................... " ..... ;:1 ............ t:l"ll)""i ..... " .....
QUIRED BY REGISTRANTS ' 122
'Sanufeturing-Use Products" ......... :: ........ ;".". 7. ... .. ..... .": '. .". .'! ...... '. ..... . . . ..... ..... .'..'...... 122
122
....... 122
,.,, - . . , -, , ,- . - .. , ..*.,.... 123
1. Additional JProduct-S'pecific Data Requirements ............. . 123
2.. ........... , ...... Labeling Requirements for End-Use Products ' ............... -. 124
'Oeeppational/Residential Labeling ................................ ; 124
' ' 133
, ,. ..... ...... ;ซ Pse Patterns Subject to Reregistration ....'... ! ' 134
and.Studies
,
Citations Considซ,..gf..tง Data Base, '." . . i . , .
, , ..... . ........ ;-. . ,,;;;; ... - ...... S,upporting the Reregistration of Triclopyr ............. 189
APPENDIX D. ....... Combined Generic and Product Specific Data Call-In . .'. . 214
'. '." " ,' ..... Attachment, , L ..... ....... Chemical .Status .Sheets ..... ....... .. ........ , ......... '. ...... 234
>EH,|! 1 - ',, I , rlllill
-------
Attachment 2. Combined Generic and Product Specific Data
Call-In Response Forms (Form A inserts) Plus
Instructions 239
Attachment 3. Generic and Product Specific Requirement Status
and Registrant's Response Forms (Form B inserts)
and Instructions . .... ... .......... 242
Attachment 4. EPA Batching of End-Use Products for Meeting
Data Requirements for Reregistration ...249
Attachment 5. List of AH Registrants Sent This Data Call-In
' ; ' , 'Notice . ..,../ ........ 255 ,
Attachment 6. Cost Share, Data Citation Forms, Confidential
Statement of Formula Form and Instructions .....257
APPENDIX E. List of Available Related Documents 271
-------
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-------
TRICLOPYR REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis ''...'
t Debby Sisco . '
John Dupuy
Frank-Hernandez
James Saulmon
Environmental Fate and Effects Assessment
Michael Davy ' -.
Andrew Brycelarid
Stephanie Syslo
David Wells
LUIS Representative
Science Information and Analysis
Branch
Economic Analysis Branch
Herbicide & Insecticide Branch
Environmental Risk Branch II
Environmental Risk Branch JJ
Environmental Risk Branch n
Environmental Risk Branch JJ
Health Effects Risk Assessment
John Redden
Yung Yang
Timothy McMahon .
William Smith
Brian Steinwand
Carol Lang
Registration Support
James Tompkins
Wesley Allen
Vicky Walter
lanBlacfcwell
Risk Management . . ,
Risk Characterization and Analysis
Branch
Toxicology Branch I ,
.Toxicology Branch II
Chemistry & Exposure Branch I
Chemistry & Exposure Branch I
Chemistry &'Exposure Branch I,
Herbicide Branch
Herbicide Branch
Herbicide Branch
Technical Review Branch
Dean Monos
Reregistration Branch JJI
-------
m..r :
vj>\,' *
i11
-------
.GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS '
;CSF
DFR
DRES
DWEL ^
EEC
EP ,
EPA
FAO/WHO
FDA
.FIFRA
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA
HOT
LC.
'50
LD<,
LEL :
LOG
LOD
LOEL
MATC
,MCLG
mg/L
MOE
MP
MPI
Acceptable Daily Intake. A now defunct term for reference dose (RfD). ' '
- Acid Equivalent , . , , .' , .
Active Ingredient ' . ';.', ,
Anticipated Residue Contribution . . ' , . ,
Chemical Abstracts Service 't , - . . , '
Cation ..'.-'' , .: '''''. ' '
Central Nervous System ..'-.:' ".'. . ,,,....
Confidential Statement of Formula ' ,
Dislodgeable Foliar Residue - , '
Dietary Risk Eyaluation'Systera , '' ' ''.' '
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e: drinking
water) lifetime'exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
Estimated Environmental Concentration.' The estimated pesticide concentration in an environment, such
as a terrestrial ecosystem. ' ' . ' \
End-Use Product. '
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health Organization ' .": '
Food and Drug Administration . ; . .1
Federal Insecticide, Fungicide, and Rodenticide Act . ' ''
Federal Food, Drag, and Cosmetic Act . .
Food Quality Protection Act ' ' , '
Functional Observation Battery'
Gas Liquid Chromatpgraphy . . '' , '. . "' -..
Geometric Mean . . '
Generally Recognized as Safe as Designated by FDA ."''
Health Advisory (HA): The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur. ' ' , .. '
Highest Dose Tested ., . ''.'.''' ' ' .'
Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of-substance per weight or
volume of water, air or feed, e.g., mg/Lmg/kg or ppm. '
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in. 50?/o-of
the test animals when Administered by the.route indicated (oral, dernial, inhalation). It is expressed as
a. weight of substance per unit weight of animal, e.g., mg/kg. . '
Lethal Dose-low. Lowest Dose at which lethality occurs. *_'[ ' ,.
Lowest Effect Level -, . , - ' '
Level of Concern _ . .
Limit of Detection .' - ' _ ;
Lowest Observed Effect Level ' . / ' , .
. Maximum Acceptable Toxicant Concentration . " . . '
Maximiun Contaminant Level Goal (MCLG) TlieMCLG is used by the Agency to regulate contaminants
in drinking water under the Safe Drinking Water Act. . ...
Micrograms Per Gram . ' . ,
Micrograms per liter . ' .
Milligrams Per Liter ., ... " " , ' .'
Mai-gin of Exposure ' ' . . - . ' ,
Manufacturing-Use Product . , ' ,
Maximum Permissible Intake , _.-. '.,.
Ill
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
MRID
N/A
NOEC
NPDES
NOEL
KOAEL
OP
OPP
Pa
PADI
PAG
PAM
PHED
PHI
ppb
ppm
PRN
Q",
RBC
RED
REI
RfD
RS
RUP
SLN
TC
TD
TEP
TLC
TMRC
tonr
WP
WPS
Caster Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No Observable Effect Concentration
National Pollutant Discharge Elimination System
No Observed Effect Level , , ;:i,i
No Observed Adverse Effect Level , . ' |
Organpptpsphate
Office of Pesticide Programs .
,1 , llj'UBf r lil ...... I"1!!1!;,!:!"!11 ....... ,,n. ''Vrli;1 ,*^T .............. .......................... ......... . ........ ........
pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion ....... ' ' ........... ....... '. ' " ' ,
Perspjiai .Protective Equipment
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified bv the EPA's Cancer Risk Model
RedBloodCeU . ' ,
Reregistration Eligibility Decision
Restricted Enlri' Interval
Reference Dose
Registration Standard
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24 (c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
^Typical End-Use Product" ...... '"" ...... " ..... ..... ........... ................... '- .......
Technical Grade Active Ingredient
'ITiin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Wettable Powder
Worker Protection Standard
"Si! J *. .. . i'l'I!"
' "
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IV
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ABSTRACT ..' . , -''.."''"'. '"'.'"",.
EPA has completed its reregistration eligibility decision:for the pesticide tricldpyr and
detennined that all uses, when labeled and used as' specified in this document, are eligible for
reregistration. This decision includes a comprehensive reassessment of the required target data base
"supporting the use patterns of currently registered products. This decision considered the
requirements of the "Food Quality Protection Act of. 1996" (FQPA) which amended the Federal Food
Drug, and Cosmetic Act and the Federal Insecticide'Fungicide and Rodenticide Act, the two Federal
.statutes that provide the framework for pesticide regulation in the United States. .FQPA became
'effective immediately upon signature and all reregistration eligibility decisions (REDs) signed
subsequent to August 3, 1996 are accordingly being evaluated under the new standards imposed by
FQPA.- - . " . ' , -.-.'" ';- .-'' .' . -. - . ' .'
,. In establishing or reassessing tolerances, FQPA requires the Agency-to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures for
which there is reliable information, as well as the potential for cumulative effects from a pesticide and
other /compounds with a'common mechanism of toxi'city. The Act further directs EPA to consider
the potential for increased susceptibility of infants and children to the toxic effects of pesticide
residues, and to develop a screening program to determine whether pesticides produce endocrine
disrupting effects. . .''.'- ''.'
Triclopyr is .a systemic herbicide used on rice, rangeland and pasture, rights-of-way, forestry
and turf, including home lawns, for control of broadleaf weeds and woody plants. There are
currently 12 registered products containing triclopyr butoxyethyl ester (BEE) and 24 products"
containing triclopyr triethylamine salt (TEA)..
' , The Agency has reassessed triclopyr food and feed tolerances under the standards of FQPA
and determined that, based on available information,' there is a reasonable certainty that no harm will
result to infants and children or to the general population from aggregate exposure to triclopyr
residues under the use conditions and limitations specified in this RED. EPA evaluated only dietary
and drinking water exposure in the aggregate assessment, since other non-occupational,exposures
to triclopyr are expected to be minimal. Calculations using existing triclopyr tolerances result in a
TMRG which represents <1% of the RfD for the general population and < 3% of the RfD for children
less than one year old, considering food only. . '
, Chronic aggregate dietary risk, including both food and an upper bound estimate of triclopyr
residues hi drinking water, accounted for 16% of the RfD for females (13+ years) and 49% of the
RfD for children ages 1 to 6. . , .
The acute dietary (food only) MOE forthe most sensitive subgroup, females of child bearing
age, is 2500, The acute aggregate dietary MOE for the sub-population of greatest 'concern (pregnant
females 13+) including food and drinking water is 1250. . ..
v
-------
Both triclopyr and the insecticide chlorpyrifos produce the metabolite 3,5,6-trichloro-2-
pyridinol (TCP). EPA conducted an assessment of the aggregate contributions of TCP from known
dietary sources using upper bound exposure estimates. The assessment indicates that, even using
exaggerated exposure assumptions, 'neither the acute nor the chronic aggregate dietary risk from the
metabolite TCP is of concern for the general population or any sub group.
ป liilK.; r M i " in i I'1!
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In reaching the determination of safety for infants and children, the Agency found that the
lojiicily data base for triclopyr is complete, based on current requirements, and that the effects
observed in pre- and post-natal studies do not indicate any increased sensitivity of infants or children
to "tpclQpyr. Therefore, the Agency has determined that an uncertainty factor of 100 (10 for
;Intercedes differences in response, and 10 for intraspecies differences) is adequately protective of
"Infants and cHildren. Thus, "for risk assessment purposes the chronic dietary (RfD) calculations
.'include a^'factor include 'a factor of 100, and the acute dietary risk assessments assume that a margin
i- linn* li';:;,,;,,tii-',-is;'!IIBI., MHI'VI:i";;:.":!'"! '!'>' i:,.K** * -.>;,:-,;,-,, ,, .r, i, ./ , , ,. , ,P
5f exposure (MOE) of 100 or greater is acceptable.
;;; The Agency has determined tiiat certain administrative revisions to the tolerance expression
and the tolerance level for "grass, hay" are required. Label amendments are required to clarify
grazing restrictions and limit maximum application rates on pasture and rangeland and other sites
where cattle can be grazed.
Ih " Mill- I ' ' '' ''. '.'' : ฐ ' ' . " '
To reduce risks to wildlife and water resources, EPA is requiring reductions in application
rates, a ground water advisory statement, and implementation of spray drift management practices.
To protect handlers, the Agency is establishing restricted'entry intervals, and specifying personal
protective equipment.
I 1 ' . '; ' ' '
Before reregistering the products containing triclopyr, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
within eight months of the issuance of this document. These data include product chemistry for each
registration and acute toxicity testing. The Agency is also requiring additional confirmatory generic
data to better characterize the fate of the triclopyr degradate TCP in the aquatic environment and its
chronic toxicity to fish. After reviewing these data and any revised labels and finding them
acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those
products which contain other active ingredients will be eligible for reregistration only when the other
active ingredients are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
', ' / ' ..'.'.- . i
In ] 988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended
to accelerate the reregisiration of,products with active ingredients registered prior to November 1,
,1984. The amended Act provides a schedule for the reregistration process to be completed in nine
years. There are five phases to me reregistration process. The first four phases of the process focus
on identification of data requirements to support the reregistration ofan active ingredient and the
generation and the submission of data to fulfill the requirements. The fifth phase is a review by the
U.S. Environmental Protection Agency (referred to as "The Agency") of all data submitted to
support reregistration. . .
FIFRA Section 4(g)(2)(A) states/that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredients are eligible for reregistration" before calling in data on
; products and'either reregistering, i products or taking "other appropriate regulatory action." Thus,
reregi strati onv involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review" is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for, additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adberse
effects" criterion of FIFRA. ,
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both.the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 3Ql.et-seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq. The FQPA amendments went into effect immediately. As a result, EPA is embarking on
an intensive process, including consultation with registrants.. States, and other interested stakeholders,
to make decisions onthe.new policies and procedures that will be appropriate as a result of enactment
of FQPA. This process will include a more in depth analysis of the new safety standard and how it
should be applied to both food and non-food use pesticides. The FQPA does not, however, amend
any of the existing reregistration deadlines set forth in ง4 of FIFRA. In addition, in light of the
unaffected statutory deadlines with respect to reregistration, the Agency will continue its ongoing
reregistration program while it continues to determine how best to implement FQPA. .
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of triclopyrincluding the risk to infants and children for any potential dietary, drinking
water, dermal or oral exposures, 'and cumulative effects as stipulated under the FQPA. The document
consists of six sections. Section I is the introduction. Section n describes triclopyr, its uses, data
requirements and regulatory history. Section in discusses the human health and environmental-
assessment based on the data available to the Agency. Section IV presents the reregistration decision'
for triclopyr. Section V discusses the reregistration requirements for triclopyr. Finally, Section VI
is the Appendices which support'this Reregistration Eligibility Decision: Additional details
concerning the Agency's review of applicable data are available on request.
-------
'EL ^ hi_ CASE OVERVIEW
..,. i;i A. ^Chemical Overyie^.
t t "I ''i"V't
It'. HI' |> ,r; i
"vThe^mipwmg act*ve inSredient(s) are covered by this Reregistration Eligibility
1=! i? I pension:
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!'*..,!,' ^Common,Name;,,,, Triclopyr
:ซ ^Chemical Name: Triclppyr[(( 3,5,6-trichloro-2-pyridmyl)oxy)acetic acid]
i ji" '',!,,'' 'f'hi ii! i' "'' i'" iii I, ' i, ii'i '!' '1' '' \ i i"1 ','': ,'i' '' i!i' "'"' ii,'''' ' i1 lit' '"'i'" I'j'i'','h'|ii ;""'ii,' '''' " '' 'I'li'' 'i'1'1 ii ,
jimi'i ,i : ' i '' "']' ,, ni| 'ป, * h '%i|i|!|[|,j I.'ii if :i';;' ! ' f,,,' ''''"]'' , /' in! ' , :, ,,, if,, i '" i;, |!,, i ' !ii!'!, i '':, ,'', ,,',!' ,,,/,' ', ! ,,i, i'1,, ปป! v^ f ,'| ' t ,
ซ!!;.;i:i*', ['.'",' Cherpical Family: Pyridinyloxyacetic acids
, ' , "i"1'.. i,'i!!l;. ' .littilll1,,,!:' ,' '"'i!. ป,''",-: ,<:ii,' ; '"i1. '"'j'l> " , i" '': " - '. !,i,,;|1,., i' / ''"''V ' ,"'',!, ' ::',! , '!:, if;, i ', , ' , ''!
." ':'" "'"CAIS Registry'Number: ' " 55335-66-3
OPP Chemical Code: 116001
Empirical Formula: C7H4C1?NO3
Basic Manufacturer: DowElanco
'V f
v. /.IS
: SB
Common Name:
CAS Registry Number:
in ii i * J
OPP Chemical Code:
Empirical Formula:
i| ,'i1 , "!!' il'l|Hii|| " ' \ I" ""1 ii 'i |l' ' 1 'i
Basic ManuiFacturer:
Triclopyr triethylamine salt (TEA)
"57213-69-1 ^ ^ " "' '"^ ' ' '
116002
c^9c4^o?;^^"''''j' '. -'
DQwElanco
Common Name:
CAS Registry Number:
I
OPP Chemical Code:
Empirical Formula:
Basic Manufacturer:
Triclopyr butoxyethyl ester (BEE)
64700-56-7 ' '" ' ' .
116004
"C13H1(;a3N04""
DowElanco
nil , in1
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B. Use Profile
The following is information on the currently registered uses with an overview of use
sites and application methods. A detailed table of these uses of active ingredients 116002
and .116004 is in'Appendix A. Currently, there are no registered uses for triclopyr acid
(active ingredient 116001). .
For 116002 and 116004:
Type of Pesticide: broad leaf herbicide,
Use Sites: . , ', -.rice,, pasture and rarigeland, rights-of-way, forestry, and turf,
including home lawns and gardens. '
Target Pests: broad leaf weeds & brush ,
Formulation Types Registered:
L Triclopyr triethylamine salt (TEA) . . ,
soluble concentrate, emulsifiable concentrate, liquid (pressurized and ready to
use), granular, formulation intermediate, wettable powder, pelleted
2. Triclopyr butoxyethyl esther (BEE)
formulation intermediate, emulsifiable concentrate, ready-to-use liquid
Method and Rates of Application:
Methods ' * '
Broadcast .
Ground (GB) , ' '.
( - Aerial (AA) , , . '
High Volume Foliar (HW)
Low Volume Foliar (LVF) '
'. . Individual Plant Treatment (IPT) . : : .
'Equipment -airplane, helicopter, ground spreader, backpack sprayers
Rates -Please refer to Appendix A for rates of application
-------
Timing - Not specified
C. Estimated Usage of Pesticide
The table below summarizes the best estimates available for the pesticide uses of triclopyr
TEA and BEE products. (Note: Data were unavailable to differentiate between usage for BEE and
TEA for the sites listed below). These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and site (crop) basis,
reflect annual fluctuations in use patterns as well as the variability in using data from various
information sources.
I'lli'i Mil)! , 1 I ' ' M ,
Table 1: Average Annual Triclopyr Usage by Site 1987-1995
i in 1 ii 1 I u ii I I-Sit
site ' ;'!
i
Pasture
Woodland
Rights of way
Rice
Railroad
Commercial/
residential use
Other
(lots and
farmsteads)
Totals
Acres grown
xtflop ,"
120,387
62,825
3.200
2,921
1,060
32,700
24,815
Acres treated
X3QOQ
327
126
75
165
90
75
66
'PeKsesofage
Treated ,
0.5%
0.2%
2.3%
5.6%
8.5%
0.2%
0.3%
Founds of AI
Applied
xiooo
292
100
85
77
45
40
34'
673
Source: US EPA proprietary sources, USDA, CA EPA, and National Center for Food and Agriculture Policy.
I!;'1 "j"
D. Data Requirements ~
s i ; ;" The Agency required the reg^stents to submit studies as specified in 40 CFR Section
158. Data from these studies are sufficient to characterize the risks associated with the uses
described in this document. See Appendix B for a complete list of data that support the
reregistration of triclopyr. "
E. Regulatory History
^ ' ; ;;;-TriHppyr TEA was first registered on May 8, 1979 as a herbicide on non-crop areas
'1:i! i' arid in forestry use for the control of broadleaf weeds and woody plants. Triclopyr BEE was
-'"- 'subsequently registered oh June 11, 1980 for use on the same sites. Both formulations were
ife!1' ' .' J?11';'1'1 !;:i!" -I eiil > i i i , i I. ' ' ' . ' ' ' ...'.::
!U ii'i
-------
registered for use on turf sites in 1984. On April 16, 1985, triclopyr BEE was registered for
use on rangeland and permanent grass pastures. Most recently (January 11, 1995), triclopyr
TEA was registered for use on .rice to control many hard to control broadleaf weed species.
An application for registration on aquatic use sites is pending. A Data Call-In Notice (DCI)
was issued in August 1991 requiring the submission of product chemistry, residue chemistry,
ecological and environmental fate data for both TEA and BEE and lexicological data for
TEA. ... . . '.".''/: ..-.'
' m. SCIENCE ASSESSMENT . ' . ' - '"'. . '.
A. , Physical Chemistry Assessment
f ' - .
Triclopyr Acid (no active products)
Empirical Formula: C7H4C13NO3
Molecular Weight: . 256.5
CAS Registry No.: 55335-06-3
Shaughnessy No.: - 116001
Triclopyr Triethylamine salt (TEA)
Empirical Formula: C13HI9C13N2O3
Molecular Weight: 371.7 " ' cl^N<^d^^^o>ffl:(CH2CH3)3+
'. CAS Registry No.: : 57213-69-1 II
Shaughnessy Np.: 116002 , '.-'. ฐ
Triclopyr Butoxvethyl Ester (BEE)
Empirical Formula: C13H16C13N04
Molecular Weight: , 356.6 ' a N -o ^ ^ ~ocfL
CAS Registry No.: 64700-56-7
.Shaughnessy No.: 116004 '' ^ '
) ' ' ~ . " "
Triclopyr is a fluffy colorless solid with a melting point of -148-150 C. Triclopyr TEA is a
grayish white granular solid with a melting point of 111-117 C. Triclopyr TEA.is slightly soluble in
toluene ( 2.7 g/100 mL) and ethyl acetate-( 2.1 g/100 mL), and practically insoluble in hexane
(O.02 g/100 mL). Triclopyr BEE is an oil-soluble liquid which is soluble in.acetontrile, methanol,
andn-hexane at^70% by weight. ^Triclopyr TEA is slightly soluble in toluene (-2,7 g/100 mL) and
ethyl acetate (-2.1 g/100 mL), and practically insoluble in hexane (
-------
The toxicological data base on triclopyr is adequate and will support reregistration
eligibility.
I . , . " , . ป.. ,o .'*' I , ' . ' , . .
a. Acute Toxicity
', H, - I ' '" I" Illiliill , 'i, , i,i , n'|. '|: , ' 'I1' n1.LI,: I,,*,, i'1":,,,;. i " 11 !", ':;i :, .' !: . , ' .'.,' , n :, ' i : , '
Acceptable studies for acute inhalation, primary eye irritation, primary dermal irritation, and
dermal sensitization were not available for the technical grade of triclopyr free acid. However, based
on the bioequivalency of the three forms of triclopyr, acute studies with the TEA or BEE form of
triclopyr are acceptable in place of the free acid. The acceptable acute toxicity studies conducted
with triclopyr indicate low toxicity with the exception of eye irritation, which was conducted with
triclopyr TEA.
The Acute Oral LD^, in male rats with the free acid form of triclopyr was 729 mg/kg and 630
mg/kg in female rats, with a Toxicity Category of ffl (MRID # 00031940). The same toxicity
categories were obtained from testing of the TEA and BEE forms of triclopyr (except eye irritation).
The Acute Dermal LDg) In rabbits using either the free acid, TEA, or BEE form of triclopyr was >
2000 mg/kg (toxicity Category HI;MRID $'s" 00056009 [free acid], 41443302 [TEA], and 40557005
[BEE]). The Acute Inhalation LC5p in male and female rats was > 2.6 mg/L using the TEA form., and
>4.8 mg/L using the BEE form with a Toxicity Category of IV (MRID #'s 41443303 [TEA] and
40557006 [BEE]). '
II ni | ,,,1,^ j/' ^jV1!!', '" jfi'lljllf" "!' ,,'i,;; ;, ,,,11;1',' ';,,:! i * : "H, ' ' '" ""i '> %. : 't!1"I!"i1' ;, ,' ;, i iv, ' , ,'|!"' '''" *.'' :, "v ..:'',"if,,,!' ' ' '!' !,' '''-. I " 'i '. ' ,'',
la a primary eye irritation study in rabbits (MRID #' 41443304) triclopyr TEA was found to
be corrosive, with cpmeal involvement present through day 21 post-dose. Using the BEE form, only
minimal eye irritation was observed (MRID # 40557007). Both triclopyr TEA and triclopyr BEE
were found to be non-irritating to the skin of white rabbits (MRID #'s 41443305 [TEA] and
40557008 [BEE]). In dermal sensitization studies in guinea pigs (MRID 5^'s 41443306 [TEA] and
40557009 [BEE]), sensitization was observed with both forms of triclopyr. It is noted that acute
toxicity studies conducted with triclopyr BEE (MRJD #'s 40557004 through 40557009) showed the
saniie''results "'as.'fhosTforticiopyr TEX, with the exception of the primary eye irritation, in which only
minimal eye irritation was observed with triclopyr'BEE.
-------
Table 2: Acute Toxicity Categories-Triclopyr Acid (Technical Grade)
2000 me/kg
Triclopyr acid TGAI study . ; .
not available '
Toxfdty
Categorf
III
III
Triclopyr acid TGAI study ,
not available '
Triclopyr acid TGAl study . \
lot available ' . .
Triclopyr acid TGAI study ' , : '
not available
Table 3: Acute Toxicity Categories Triclopyr TEA (44.4% a.i.)
Gm-deKaeMx
81-1
81-2
81-3
81-4
81-5
81-6
StoftHyyt
/ "
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Results
LD,0 = 1847 mg/kg (M+F)
LDw>20QOms/ks
LC,0 >2.6 mg/L
, Corrosive
Not irritating
sensitizer .
' ToXieity
Ciitegiarrf
III
III
- ,IV
I "
'. IV
N/A
Table 4: Acute Toxicity Categories-Triclopyr BEE (97.1% a.i.)
C^adeKneKa
81-1
81-2 .
81-3
81-4
81-5
81-6
Study Type
Acute Oral
Acute Dermal -
Acute Inhalation
Primary Eye Irritation ! '
Primary Dermal Irritation
Dermal Sensitization
%Hesslts
LD,0 = 803 mg/kg (M+F)
-LD,0 >2000 mg/fcg
LC,0>4.8mg/L
Minimally initating
, . Not irritating
sensitizer
T0xic%
Category
III
III '
IV
III
: IV-
N/A.
-------
111,
Bioequivalency
It is noted that toxicology studies conducted with triclopyr have been performed using
either the free acid, taethylamine"salt (TEA), or the butoxyethy! ester (BEE) form of triclopyr.
The issue of bioequivalency for the purpose of testing the three chemical forms of triclopyr (acid,
triethylamine salt, and butoxyethyl ester) was addressed by the registrant conducting special
studies with the triethylamine and butoxyethyl ester forms of triclopyr. These studies, which
included data on comparative disposition, plasma half-life, tissue distribution, hydrolytic cleavage
under physiological and environmental conditions for triclopyr triethylamine salt and triclopyr
butoxyethyl ester (MRID #'s 43394101, 42444701, and 42437901) were found to adequately
address the issue of bioequivalency. In addition, subchronic toxicity studies conducted with each
form supported the pharmacokinetic data in demonstrating bioequivalence. Therefore, with the
exception of the acute toxicity database (where differences in Toxicity Categories have been
nqted above), studies conducted with any one form of triclopyr have been used to support the
toxicology database as a whole^
b. Subchronic Toxicity
In a subchronic oral toxicity study (MRID # 00150378), male and female Fischer 344 rats
received dietary concentrations of triclopyr technical (98% a.i.) at doses of 0, 5, 20, 50, or 250
msf/kg/day for 13 weeks. Degeneration of the proximal tubules of the kidneys of male and female
ratg was observed In increased incidence at 20 mg/kg/day and above for both sexes. Absolute and
relative kidney weight was significantly increased in male rats at the 50 mg/kg/day dose, while
relative kidney weight was increased in male and female rats at 250 mg/kg/day. The systemic
NOEL was 5 mg/kg/day, and the systemic LOEL was 20 mg/kg/day, based on
histopathological changes in the kidneys of male and female rats. This study is acceptable
and satisfies the guideline requirement [OPPTS 870.3100; OPP ง82-l(a)] for a subchronic
toxicity study in rodents.
In a 183-day toxicity study in dogs (MRID # 00071794), male and female beagle dogs
received dietary doses of triclopyr technical at 0, 0.1, 0.5, or 2.5 mg/kg/day for 183 days (males)
or 184 days (females). There were no significant treatment related effects on body weight, food
consumption, hematology, or clinical chemistry in male or female dogs. A decreased rate of
1 phenolsulfbnthalein (PSP) excretion was observed in dogs receiving 2.5 mg/kg/day triclopyr.
This effect was later determined to be a result of competition between triclopyr and PSP for renal
excretion, and was not considered toxicplogically relevant (HED document # 008593). The
Systemic NOEL was determined to be > 2.5 mg/kg/day, and the Systemic LOEL was
determined to be > 2.5 mg/kg/day in both sexes. This study is supplementary and does not
satisfy the guidelinei requirement for a subchronic toxicity study [OPPTS 870.3151; OPP
ง82-1 (b)] In non-rodents.
;:"ii, ." : ' ' , .'.,.,ni ,' ' ;: . /:. . "',",;., . ,; f - ;' ,-. . "; ... . [ ''.
ซ .," ,, ! , ! , ''M '' ' , '/ , ., ;,, ,'. '. i ; '-.. - ': ',", ...:' I . '; .
c. Chronic Toxicity
; ; ... ... ' .; ฃ; . ' . ' , ,, ;.::;.; 3"
-------
In a 228-day toxicity study in dogs (MRID"# 00071793), male and female beagle dogs 14
months of age were administered Triclopyr technical in the diet at doses of 0, 5, 10, or 20
mg/kg/day for 228 days. At the 20 mg/kg/day .dose level, body weight gain in male dogs for
weeks 0-13 (days 0-95) was decreased 4% below control, and weight gain for the entire study
period was decreased 5% below control. For female dogs, body weight gain for weeks 0-13
(days 0-95) was decreased 27% vs control, and was decreased 20% vs control for the entire study
period. The decrease in body weight gain for female dogs was matched by a similar decrease in
food consumption for both the 0^95 day time period and the 0-228 day time period (21%
decrease). 'Food consumption in male.dogs was decreased by 12% for the 0-95 day time period
and by 2% for the entire study period. In male and female- dogs, hematological parameters at 172
days showed decreased packed cell volume (21% in both sexes), decreased hemoglobin (24% in
males, 26% in females), and decreased red cell count (16% in males, 20% in females). These
decreases were still observed in both sexes at day 225 of the study. Elevations in alkaline
,phosphatase (approximately 2-fold in males and females), SGPT (approximately 2-fold in males,
2-6-fold in females), and SGOT (approximately 2-fold) were observed in male and female dogs at
the 20 mg/kg/day dose on days 167, 176, and study termination:. Absolute and relative liver
weight in male dogs was increased 18% and 26% respectively at the 20 mg/kg/day dose, while .
relative kidney weight was increased 12% in females at the 20 mg/kg/day dose. Increased
incidence of microscopic liver pathology was noted at 20 mg/kg/day in both male and female dogs
(focal aggregates of reticuloendothelial cells containing brown pigment surrounded by degenerate
appearing hepatocytes; focal areas of eosinophilic granulomatous inflammation).
Based on the decreased body weight gain in male dogs, decreased hematological
parameters in male dogs, changes in clinical chemistry in male and female dogs, and liver
histopathology in male and female dogs, the LOEL is 20 mg/kg/day for male and female dogs.
The NOEL is 10 nig/kg/day. 'This study is classified as acceptable and, in conjunction with
MRID 41200301 (1-year-toxicity study in-dogs), satisfies the guideline requirement for a chronic
oral toxicity study in dogs [OPPTS 870.4100; OPP ง83-1 b], .
" In a one year dietary toxicity study (MRTO # 41200301), Triclopyr technical (98.9% a.i.)
was administered to male and female beagle dogs (4/sex/dose) at doses of 0, 0.5, 2.5, or 5.0
mg/kg/day. There were no significant effects of treatment on mortality, clinical signs, body
weight, or food consumption in male and female dogs at any dose level tested. Increases in urea
nitrogen and creatinine were observed at all dose levels tested. At 12 months,'urea nitrogen was
increased by 12, 37, and 68% in male dogs and by 11, 17, and 35% in female dogs. Creatinine
was increased by 30 and 40% in male dogs at the 2.5 and 5.0 mg/kg/day dose levels, and
increased by 55 and 44% in female dogs ,at 12 months. The changes in clinical chemistry at 2.5
and 5.0 mg/kg/day, while statistically significant,' do not represent a toxic response to the test
chemical,, but a physiologic response of the dog, based on the limited ability of the dog to excrete
organic acids at higher plasma concentrations. The lack of histopathologic alterations in the
kidneys of both sexes is supportive of this conclusion,,
9
-------
F 1 iiiiiii i,imp,"inini" iiiiiiKF'Hill' iTjii iiniiniK i : 11 Him iiiiiiiiiiiii iiiri,gnui"'!"1; ttLtHtauK*nmm1'-vxn'mu1* ปTiiici-!1111 <) s;~:; us11; vwe WBR::;.Kป ;;<:-f:* ;' './',K , '
lililitlB i . i 'i1;; i .I!- 'Jin;
'iiliiSii.' '"ill tlV it ; ii"
iSii] ;; '', , ,,' IM V ' Si-',', ;', ซ' _ i, i;iM,; ';"';,''',""," ./'r' :;"i'l) "'1;, '" ' .''V*>'.'; l ': ' :i:-,:.' ,: |; ! ', - , .; '''', . ;
SB;;!! i1, :.'. ! ,," MS:;'.ป. :.". ,..'.,.::: <., ; .:.<.,,' .,. / ,;,": : . .1.l;; .' ? ,'":: ', -\: ,'. . :
The Systemic NOEL is > 5.0 mg/kg/day for both sexes; the Systemic LOEL is > 5.0
'. ;;:::, This study is classified as supplementary and does not satisfy the guideline requirement
for a chronic tqxicity study in non-rodents. However, in conjunction with MRID # 00071793,
these two studies fulfill the guideline requirement (OPPTS 870.4100; OPP ง83-1) for a chronic
toxicity study in non-rodents. Therefore, the guideline requirement is satisfied.
Hill II 1 >' I ',,''''
d. Chronic Toxicity/Carcinogenicity
In a chronic toxicity/carcinogenicity study, triclopyr technical (98.0% a.i.) was
administered in the diet to groups of male and female ICR mice at dose levels of 0, 50 ppm (5.55
mg/kg/day in males, 5.09 mg/kg/day in females), 250 ppm (28.6 mg/kg/day in males, 26.5
, mg/kg/day in females) or 1250 ppm (143 mg/kg/day in males, 135 mg/kg/day in females). Main
I a test groups of 60 mice/sex/dose received diets for 95 weeks, while satellite groups of 40
; mice/sex/dose were used for sacrifice of 10 mice/sex/dose at 26 and 52 weeks of treatment at the
same dose levels (MRED # 40356601).
'I! I lIMI II '.'I1 ii , -
f /L ' ' I IIII II I, " ' , ' , i
'. :1. i ill ' I1 ':.' '" ." '.' ' '.' .
- At 143 mg/kg/day in males and 135 mg/kg/day in females, body weight gain in male mice
was decreased10.1%ivs control for the 22-month study period, whik body weight ^ain in female
mice was decreased 10.6% for the 22-month study period. An increase in the incidence of thymic
enlargement was observed hi high dose male and female mice, but there Were no data on thymus
l!:;*!i'v'i;ii:Jl|r:', :::"l!" "weight. - ,
| If;,',;,;{,';;. ,,; r| , ^{ j > Af 26 weeks of treatment^ plasma BUN in male mice 'at 143 mg/kg/day was increased
J*1'11 i:ii ;! 25% vs control, while water consumption was increased an average of 25% at this dose beginning
41 iiilitilF ,1,i!'1}!;1::,;1',;;i|!li'iililiiL . ;/ ,,: ii'iiiiiiii!' ,;i;,,, ,iii1i''i,1,'"'I'l-'iiii F" ^'v in j i,ซ,i ir-.r^rir, ~\, / ,r ,,,,11 *i ,,] ;r , " ,,
:;::::,, ; , : at week 13 of the study. In female mice, kidney weight was increased 10-16% at the 135
ซซ:*; J;; ,-;; mg/kg/day dose, while urinary protein at the 135 mg/kg/day dose was also increased at week 52.
However, there were no pathology data to support a true toxic effect on the kidney of males or
females. Liver weight in male mice was increased by 17% at the 143 mg/kg/day dose level at
, week 26 only. ' .
lilllliiilliiiiliii i, I r-Mi ft ),! 'i i II ' -', '; ,!'!'' , ''::.l .i '.! ! '", , I '. i: ."'., -.",,( '.( :,, .!',,.! fl'ii,1 k , . ' , . " .
Sr iljiijjt, '" ,',1,/ff1', ' %;:i";|: ,," I,,,,,,, ",",, :, Ti'' " lli:;. ,,,,;,,,! "l-St ':,.' , T, ' ,i ,,',ป 'i,;.'ซ!, ' V" ' ,' t;,;,, :ป' ' i1 i ' ' '. , ' ", .' ''
For the chronic toxicity portion of this study, the LOEL was tentatively considered to be
oTH-r,.! "i s us 143 mg/kg/3ay in male mice and 135 mg/kg/day in female mice, based on the decreased body
! il!-' !i weight gain. The NOlEL is considered to be 28^6 mg/kg/day in male mice, and 26.5 mg/kg/day in
female mice,
-: I There were no compound-related tumors observed in male mice. Female mice had a
significant increasing trend in mammary gland adenocarcinomas at p < 0.05. There were no
significant differences in the pair-wise comparisons of the dosed groups with the controls.
I , "i ,",'.. :; \ * :ป iir'isi! .',' ' : . i i ,.,.. , ;
V ' i"," " ISMS.! -I,,,", ,",! I . i . ,
Support for the selection of the high dose in the chronic toxicity/ carcinogenicity study in
,:, mice is taken from 128-day range-finding study in which male and female mice were exposed to
111 "' '"'HI ' , n , , , , ' ' ' ' ' ' '
, , ..10' " ' ' ' '
-------
triclopyr technical in the diet at dose levels of 0, 200, 400, 800, 1600, or 3200 ppm (nominal
doses of 30, 60, 120, 240, and 480 mg/kg/day). At the 480 mg/kg/day dose, male mice were
observed with single cell necrosis of the liver,* significant increases in alkaline phosphatase, AST,
and ALT, and enlargement of the liver with dark color. Centrilobular swelling and degeneration of
hepatocytes were observed in a dose-dependent fashion at 120 mg/kg/day and above in male
mice, along with mild increases in liver enzymes at 240 mg/kg/day. (MRID #40356601).
. m a chronic toxicity/carcinogenicity study, triclopyr technical (98.0% a.i.) was
administered in the diet to groups of male and female Fischer 344 rats (50/sex/dose) for 2 years at
dose levels of 0, 3, 12, or 36 mg/kg/day. Additional groups of 10 rats/sex/dose received dietary-
exposure to triclopyr at the same dose levels for 6 and 12 months (MRID # 40107701 )..".-
Mortality in treated groups of male rats was lower than that in. the control group.
Cumulative mortality was stated as 50%, 32%, 26%, and 36% for control, low," mid, and.-high
, dose level male rats. Red cell count, hemoglobin,.and hematocrit in male rats was numerically
decreased at the high dose at 6, 12, and 24 months. Statistical significance was achieved for the
decrease in red cells at 12 months, for hemoglobin at 6 months, and for hematocrit at 6 and 12
months. Absolute and relative kidney weight was significantly increased (10-17%) at the high '
dose in male rats, with an apparent dose-related trend at 12 months. Female rats showed an
increased incidence of pigmentation of the proximal descending tubule .at all dose levels compared
to control, while male rats in the 6-month satellite group showed increased incidence of proximal
tubule degeneration at the 12 and 36 mg/kg/day dose levels compared to control.
For chronic toxicity, the NOEL was 12 mg/kg/day for males and 36 mg/kg/day for
females. The LOEL for males was,36 mg/kg/day based on marginal increases'in proximal tubular
degeneration at 6 months. ' .
There were no significant increasing trends in tumor incidence for male rats. There were
significant pair-wise differences vs control at 3 and 12 mg/kg triclopyr in the incidence of adrenal
gland benign pheochromocytomas and benign and/or malignant pheochrornocytomas combined,
and in the incidence of skin fibromas at 3 and 12 mg/kg, with p < 0.05 for all comparisons except
the incidence of pheochromocytoma (benign + combined) at 12 mg/kg, (p < 0.01 vs control).
s.
Female rats had significant increasing trends in mammary gland adenocarcinomas at p <
0.05 and in adenomas and/or adenocarcinomas combined at p < 0.01'. There was a significant-
difference in the pair-wise comparison of me 36 mg/kg/day, dose group with the controls for
mammary gland adenomas and/or adenocarcinomas combined at p < 0.05. There were no
significant pair-wise comparisons or trends for the incidence of adrenal gland pheochromocytoma
in female rats. ' , . . .
e. Developmental Toxicity
11
-------
iiiiiii i '! i !?! tm" i ;mi: n*:- s m iif^w/fr" P? w w:. : (I'^.i^r- 11 n*$ww if imw-wmi ซs :!i!F"!: 'vfv^^yv," -?!
A developmental toxicity study was conducted with the butoxyethyl ester (BEE) form of
triclopyr in rabbits^ In this study, (IvtfOD^ '4321%di;''lffi"(iocimiBirt'1# 011107), triclopyr BEE
technical (96,9% a.i.) was administered at doses of 0, 10, 30,'and. 100 mg/kg/day to pregnant
New Zealand Ijite rabbits on gestation days 6 through 18 inclusive.
Til'..'.
Maternal toxicity was evident at the 100 mg/kg dose level in the form of mortality during
test article administration. In addition, cesarean section data showed a decrease in total number of
live fetuses, live fetuses/dam, an increase in post-implantatipn loss (f> < 0.05), and an increase in
tptaf fetal Sealhs at100 mg/lcg7day. The maternal LEL = 100 mg/kg based on the increase in
mortality'at this dose. The maternal NOEL = 30 mg/kg.
Developmental toxicity was evident at the 100 mg/kg dose level in the form of a decreased
total number of live fetuses, increased total fetal deaths, increased fetal incidence of additional
steJSiebral centers, increased incidence of reduced ossification of the digital bones, and an increase
in the percentage of fetuses with 13 ribs. The developmental LOEL = 100 mg/kg, based on the
cesarean section observations of decreased total live fetuses and increased total fetal deaths, as
well as the observations of increased fetal and/or litter incidence of skeletal anomalies and variants
observed at this dose.The developmental NOEL = 30 mg/kg.
A developmental toxicity study was conducted with the triethylamine (TEA) salt of
triclopyr in rats. In this study, (MRID 43217602; HED document # 011107), triclopyr TEA
technical (46.5% a.i.) was administered to timed-mated Crl:CD(SD) BR VAF/Plus female rats on
gestation days 6 through 15 inclusive. Doses used were 0, 30, 100, or 300 mg/kg, corrected for
compound purity.
Maternal toxicity was suggested at the 300 mg/kg dose level from the increased incidence
of clinical signs (salivation) and mortality (1 death). Cesarean section data showed no
toxicologically significant alterations in any parameter in treated rats vs control. The maternal
LOEL = 300 mg/kg based on the increased incidence of salivation and mortality. The maternal
NOEL =100 mg/kg. " :" | ' '
lid ,' "I|M i,1, ;i, '."I, ,;;,ป: I ' .:"' ,,1i|li:v!!1 ' ,.'!;', , "!. |'|11;.1'1I l! -L ^ .'"'t 1 ',n J| :,i'' , ( i1''^ :' 11;''''i'lii. Til ii, .' ., ,' / :
,;i!lii;,:,':,, ' T" ' p' ' ' 'r1'1 . ' I 11.11*11' .lil" . ซ " "' ,: :, ,V,. V'1 '' '!'. "'!' I' '." ...l'1.' I",-'',!'' .. ,i:,,ซil! . !' : ' ' i ' ' \
': Developmental toxicity was evident in this study at the 300 mg/kg dose level, and included
decreased mean fetal body weight, increased fetal and litter incidence of skeletal anomalies
(reduced ossification of one or more cranial centers and sacrocaudal vertebral arches) and an
!nc|ease iri the number; of fetuses with unossified sternebrae. The developmental LOEL = 300
mg/kg based on decreased mean fetal weight, increased fetal and litter incidence of skeletal
anSinalies, and increased fetal incidence of unossified sternebrae. The developmental NOEL =
100 mg/kg.
^1,: A dev'elopmental toxicity study was conducted with the TEA salt of triclopyr in rabbits. In
this study, (MRID 43217603), triclopyr TEA technical (46.5% a.i.) was administered to pregnant
New Zealand White rabbits on gestation days 6 through 18 inclusive. Doses used were 0, 10, 30,
or 100 mg/kg, corrected for compound purity. Insemination was by natural means.
12
-------
Maternal toxicity was evident at the 100 mg/kg dose level in the form of increased
mortality during test article administration, decreased body weight gain and food efficiency, and
increased liver and kidney weights. Based on these observations, The maternal LOEL = 1.00
mg/kg based on the decreased body weight gain, decreased food efficiency, and increased liver
and kidney weight. The maternal NOEL = 30 mg/kg. . . ;
Developmental toxicity was evident at the 100 mg/kg dose level in the form of reduced
number of litters, reduced number of corpora lutea,; reduced number of total implants, reduced
total live fetuses, increased, embryonic deaths and deaths/dam, and increased pre-implantation
' loss. The developmental LOEL =100 mg/kg based on the decreased number of live implants,
decreased live fetuses, and increased embryonic deaths. The developmental NOEL = 30 mg/kg.
f. Reproductive Toxicity
In a two-generation reproductive toxicity study with the acid form of triclopyr, (MRID #
435457-01; HED document # 011882), male and female Sprague^Dawley rats (30 males/dose; 30
females/dose), received triclopyr technical (99.4% a.i.) in the diet at nominal doses of 0, 5, 25,'or
250 mg/kg/day (Pj .high dose males received 100 mg/kg/day for the first 29' days of the study).'
The PI generation received triclopyr.in the diet for 10 weeks prior to breeding. After 10 weeks,
the P! animals were mated on a 1:1 ratio . Following weaning of the Fj litters, 30 males and 30 "
females from each treatment group were selected as parents for the next generation. Selected Fj
rats were treated for 12 weeks with technical triclopyr and then.bred to produce the F2.litter.
Significant systemic toxicity was observed at the 250 mg/kg/day dose level in the Pj and
P2 parental rats, and included decreased body weight and weight gain during pre-mating for males
and females, and decreased body weight and weight gain during gestation for P: and P2 females.
.For the'Pj parental rats at 250 mg/kg/day, decreased mean litter size was observed as was mean
pup weight on days 1, 4, and 21 post-partum; an increased incidence of pup deaths was also
observed at 250 mg/kg/day ."In the P2 parental generation, decreased number of litters, mean litter
size, number of live pups, and pup weight were significantly decreased at 250 mg/kg/day. In the
F! .and F2 litters, survival at 250 mg/kg/day was significantly decreased vs. control, as was mean
litter size and body weight and weight gain.
At the 25 mg/kg/day dose, an increased incidence of degeneration of the proximal tubules
of the kidney was observed in the Pl and P2 parental rats of both sexes. The increase at 25
mg/kg/day was dose-related. . ,
, The Parental Systemic Toxicity,NOEL = 5 mg/kg/day (males and females); .the Parental
Systemic Toxicity LOEL = 25 mg/kg/day, based on increased incidence of proximal tubular '
degeneration in male .and female PI and P2 rats. ,
13
-------
:kW'i< I "lit1!1" f Ml
Khliliil l, .SKI'i. ' 'S'4
III! IK,,,
: an ,: EBi In, The Reproductive/Systemic Toxicity NOEL = 25 mg/kg/day; the Reproductive / Systemic
Toxicity LOEL = 250 mg/kg/day, based on decreased litter size, decreased body weight and
weight gain, and decreased survival in the Fl and F2 litters.
g. Mutagenicity
MI The mutagjenic potential of triclopyr has been adequately evaluated in a range of assays in
vivo and in vitro. These assays demonstrate triclopyr is non-mutagenic in vivo and in vitro. These
studies are summarized below.
In an Ames mutagenicity assay (MRID # 41732202), triclopyr BEE (98% a.i.)was found
to be non-mutagenic in the four tester strains of Salmonella typhimurium (TA98, TA100,
TA1535, and TA1537) hi the presence or absence of metabolic activation at the concentrations
tested (50-5000 fig/plate). In an in vivo micronucleus 'assay in mice, triclopyr BEE was not
clastogenic in the mouse micronucleus test at the dose levels tested (0, 60, 200, or 600 mg/kg)
[EPA MRID '4 4i7?7l'6lirin1an'unsciie'duled DNA synthesis (UDS) assay in rat hepatocytes, ''
triclopyr BEE did not cause DNA damage or inducible repair in the rat hepatocyte unscheduled
DNA synthesis assay at the concentrations oflest article used in this study (1.0-1000 Aig/ml) [
EPA MRID # 41747102].
The mutagenicity of'triclopyr technical acid was evaluated in a recombination repair
system using rec- assay mutant (HIT) and recombination repair deficient mutant (M45)'of JL
subtilis and was also tested in the reverse mutation assay using Salmonella strains TA 98 and TA
100. Concentrations 'used in .tlie rec- assay were 20-2000 Aig^isk, and 1-5000 ^.g/plate in the
reversion assay.
In the rec- assay, there was no evidence of growth inhibit] on for the repair competent or
repair deficient bacterial strains employed. In the reversion assay, there were no increases in
number of revertant colonies in the absence or presence of liver S-9 for the strains of Salmonella
employed [ EPA MRID # 00038408]. In an Ames assay, the mutagenic potential of triclopyr
technical (98.0% al) was assessed in Salmonella tester strains TA-1535, "TA-1537, TA-1538,
TA-98? and^TA-100 inthe absence and presencepf metabolic activation (rat liver S-9). .
Concentrations usel were 10, ipdo, and 10,000 ^g/plate. There were no significant increases'in
the number ofrevertant colonies for any of me tester strains employed in this study in the absence
or presence of metabolic activation [ EPA MRID # 00031939 ].
1 * S'; In a dominant lethal assay, groups of 30 male mice were maintained on dietary levels,of
, triclopyr of 0, 3, 15* or 70 mg/kg/day for 9 consecutive weeks. Immediately following treatment,
eagh male was mated to 4,untreated mature .virgin females for 7 consecutive days. Two of the 4
females iri each group were held for the dominant lethal study. Ten days following the last day of
cohabitation, females were sacrificed and uteri examined for live and dead implants. There were
no significant toxic effects observed hi treated male mice, and no significant differences in body
weights. There were no significant effects on fertility index, average number of implantations,
.;'-. , ,' '. -,;, .,: ; . : 14 " ' ' ' _
-------
average number of resorptions, average resorption rate, or average litter size in any of the
untreated female mice bred to treated males at all dose levels of triclopyr tested [ EPA MRID #
00028996]. , '.-.".' , .
In a dominant, lethal assay, triclopyr at doses of 0.7, 7.0, andJO.O mg/kg, triethylene
melamine (positive control) at a dose of 0.3 mg/kg, or negative control (corn oil plus saline) were
administered orally to separate groups of 10 male Sprague-Dawley rats. Males were sequentially
mated to 2 untreated females per week for 7 weeks. Females were killed at 14ฑ2 days after
mating. There was an apparent decrease in mating index during week 1 at the 7 and 70 mg/kg
dose levels. A trend towards an increase in average number of resorptions was evident at the 7 ,
and 70 mg/kg dose levels, but statistical significance (by t-test) was apparent only at week 4 at the
7 mg/kg dose, week 5 at the 70;mg/kg dose, and week 7 at the 70 mg/kg dose. Statistical:
comparison by t-test is not appropriate in this type of experimental design. The proportion of
females with one or more dead implantations also appeared increased at the 70 mg/kg dose level
over negative control. The ratio of dead implants to total implants was also increased at the 7 and
70 mg/kg dose levels, but the increases were numeric in most of the cases [ EPA MRID #
,00057087]. . ..' .. ' '.'- ".'''''..
In an unscheduled DNA synthesis assay, rat primary hepatocyte cultures were exposed to
triclopyr at concentrations of 5x10'3, 1.56 x 10'3, 5 x 10'4, 5 x 10'5, 1.56 x 10'5, and 5 x-10'6M
for 18 hours in the presence of 10>Ci/ml 3H-thymidine. Triclopyr failed to induce any increase in
s net nuclear grain counts at any of the concentrations tested. Hepatocyte toxicity was
demonstrated at 5. x 10'3 triclopyr (OPP 84-2; MRID #40055702).
In a host-mediated assay, triclopyr was administered orally at doses of 0, 0.7, 7.0, or 70,0 '
mg/kg to groups of 10 male IGR random bred mice, In the acute test, the indicator organism
, (Salmonella TA-1530, Salmonella G-A6, and Saccharomyces.D-3') was injected i.p. immediately
after administration of test material. In subacute tests, the indicator organism was injected 1/2
hour after the last of 5 administrations of test material (5 times at 24 hour intervals).
Intraperitoneal fluid was recovered, diluted, and plated,for determination of revertants and
recombinants. Triclopyr in this study induced no significant increases over negative control in
mutant or recombinant frequencies at the dose levels used in this study [EPA MRID #00057085].
In an in vivo cytogenetics study in rats, triclopyr was administered to groups of 5
Sprague-Dawley rats as single doses of 0.7, 7,0 , and 70.0 mg/kg, or for 5 days to additional
groups of 5 rats at the same'dose levels. In the single dose study, rats.were sacrificed at 6, ,24, and
48 hours after test administration, while in the repeated dose study, rats were sacrificed at 5 days
after the last dose. Examination of bone marrow cells for chromosomal aberrations from the acute
and subacute groups showed no cells with chromosomal aberrations [ EPA MRID # 00057086 ].
h. Metabolism
15
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,"! i i I1, , , 'I! i ' ' i ' '' 1 : ' ; . ;''': ; -' "
i
Disposition and metabolism of 14C-triclopyr acid (98.8% a.i.) was investigated in male and
female rats at a low oral dose (3 nag/kg), repeated low oral doses ( 3 mg/kg x 14 days), and a high
dose (60 mg/kg) (MRID# 41353001]. Comparisonof disposition ,data in intravenously dosed
and orally dosed rats demonstrated that triclopyr was well absorbed after oral administration.
Excretion was relatively rapid at the low dose, with a majority of radioactivity eliminated in the
urine by 24 hours. At 60 mg/kg, urinary elimination of 14C-triclopyr derived radioactivity was
dec|eaงed,|nrrjale andi,fem,ale,rats,ifrom 0-12 hours, due to apparent saturation of renal elimination
melihanisms. Fecal elimination of 14C-triclopyr derived radioactivity was a minor route of
,;j;:^;!y;j,:r '! exgptipnj as was elimination via exhaled air. No significant effect was observed on metabolism or
disposition of MC-trlclopyr from repeated low oral dosing in male or female rats.
! '" '"' Residual 14C-triclopyr derived radioactiviry was minimal in all dose groups, but measurable
levels of tissue radioactiviry were detected in perirenal farof both sexes and ovaries of female rats
which apparently increased with dose. Thus, potential accumulation of I4C-tiiclopyr derived
radioactivity may occur in these tissues.
; ffiil : Urinary metabolites of 14C-triclopyr were isolated and identified by HPLC and GC/MS.
Unmetabolized parent cnemical represented >96% of urinary radioactivity, with the remainder
accounted for by the metabolite 3,5,6-trichloro-2-pyridinol (3,5,6-TCP), and possible glucuronide
and/or sulfate conjugates of 3,5,6-TCP.
f; I IJiasma elimination following intravenous administration of 14C-triclopyr was consistent
a one-compartment model with an elimination naif-life of 3.6hr and zero-order kinetics from
0-12 hours at the 60 mg/kg dose. Kinetic parameters were optimized using SIMUSOLV modeling
software. The model showed an apparent "flip-flop" phenomenon, in which absorption at the 3
fngTkg dose was rate limiting in elimination of 14C-triclopyr derived radioactiviry, but renal
excretion was saturated and therefore, limiting in elimination of 14C-triclopyr derived radioactiviry
at the 60 mg/kg dose.
2. Dose Response Assessment
, , fijiii, ; ' ., :; ' "Si ,,,," M, \: .1 '; . -.,,1 , ;; ป.', .:',''. .., ' .:.'.; ,- " - '..i '',! <: : ' i
', :.[!,. ,',:.: i a.' I Reference Dose i - ,
TilHlf" ! 'I "", ' " ' . , r JJItl 'i n, ',i ; ', :;,.'i,,ป , ,'. , ..i!1,1' >, ,':" ,,! " ,i ' " l:; ' , '; ,/ ', , l\ ., . ซ,
:":' The Reference Dose (RfD) for triclopyr was established at 0.05 mg/kg/day, based upon
the 2-generation reproduction toxiciry study in rats (83-4, MRED # 43545701) with a NOEL of
5.0 mg/kg/day, the lowest dose tested (RfD Peer Review Report of triclopyr, January 12, 1995).
At the next dose level (25 mg/kg7day), an increased incidence of proximal tubular degeneration of
the, kidneys was observed in PI and P2 parental rats in this study. An uncertainty factor of 10 for
intejspecies differences in response and an uncertainty factor of 10 for intraspecies differences in
response was "applied. " ' "
b. Dermal Absorption
16
..Stil:i>i !k;1
-------
Percent absorbed: Blood levels and urinary excretion of triclopyr were monitored in five
human volunteers who received 3.7 mg/kg triclopyr BEE on the forearm for a duration of 8
hours. Dermal absorption from this study was calculated to be 1.65% of the applied dose
(Carmichael, N.G. Et al. (1989): Oral and Dermal Pharmacokinetics of triclopyr in Human
Volunteers.:Human Toxicol. 8r 431-437 V ' . '- . '
Also, in a rabbit dermal absorption study (Accession #259680, comprised of MRID#
00153805 and 00153807), 1.5% of an applied dose of triclopyr acid (2 g/kg) was reported to be
absorbed through the skin. This study was graded core supplementary. '
c. Other Toxicological Endpoints
The Agency's Toxicology Endpoint Selection Committee (TESC) considered the available
toxicology data for triclopyr at a meeting held on June 11, 1996. Toxicity endpoints and dose
levels of concern were identified for use in risk assessment corresponding to acute dietary.
exposure, short and intermediate term occupational or residential exposure, and chronic
occupational or residential exposure: ,
Acute Dietary
To estimate acute dietary risk a dose level of 3 0 mg/kg/day was identified as the NOEL
from a developmental toxiciry study in rabbits (MRID # 43217601) administered triclopyr BEE.
This NOEL was selected, based on toxicity noted at the next highest dose of 100 mg/kg in which
decreased number of live fetuses, increased total fetal deaths, increased resorptions, increased
fetal incidence of additional stefnebral centers, increased litter incidence of reduced ossification of
digital bones, and increased percentage of fetuses with 13 ribs was reported.
Short and Intermediate Term Occupational and Residential
In a 21-day dermal toxicity study in rabbits (MRID #422:12701), signs of systemic
toxicity were limited to decreased alkaline phosphatase in male and female rabbits at 1000
mg/kg/day and increased absolute and relative liver weight in male rabbits at 1000 mg/kg/day.
These effects were considered marginal and not of toxicological significance.
The TESC recommended that risk assessments for short- and intermediate term '
exposure were not required since the NOEL was > 1000 mg/kg/day (limit dose) in a 21-day
dermal toxicity study in rabbits. .'..-'" '
Chronic Occupational and Residential (non-cancer)
For-chronic (non-cancer) occupational or residential exposure risk assessment, a dose
level of 5 mg/kg/day was identified as the NOEL for parental/systemic toxicity in a 2-generation
reproduction toxicity study in rats (MRID #43545701). This NOEL was selected based on the
; "' 17 . '-'
-------
observation of proximal tubular degeneration of the kidneys of PI and P2 parental rats at the next
highest dose of 25 mg/kg/day.
Inhalation Exposure (any time period)
I :.. ..-. , i ,- i'!ii! 'i.'" ': ,.,.'ii" '.r.r. 'i.'L1''... "> ii'-: "i: : ;:*),,; /'tvi/.. '.,*' ,. ^ "-.;. "'. W - -I , '. '' . ,
In an acute inhalation toxicity study (MRJD # 41443303), the acute inhalation LC50 was
determined to be >2J5 mg/L in male and female rats, with a Toxicity Category of IV.
The Committee' concluded' that a separate risk assessment for this route of exposure is not
required based on the placement of trlclopyr in Toxicity Category IV. Significant toxicity
resulting from inhalation exposure is not expected.
d. Cancer Classification
As a result of the August 9, 1995 meeting of the Agency's Carcinogenicity Peer Review
Committee (CPRC), triclopyr was classified as a Group D chemical (not classifiable as to human
carcmdgeniclty). This decision was based on increases in mammary tumors in both the female rat
and. mouse, and adrenal pheochromocytomas in the male rat, which the majority of the CPRC
believed to be only marginal. Overall the majority of the CPRC felt that the animal evidence was
malginal (not entirely negative, but yet not convincing). Therefore, the consensus of the CPRC
was to classify triclopyr as a Group D chemical, based on what was considered only marginal
response and the absence of additional support from structural analogs or genotoxicity.
3. Exposure Assessment
a. Dietary Exposure From Food
The only current direct food use of triclopyr is on rice. However, triclopyr is also used
on a variety of sites, such as pasture and rangeland, where livestock graze. Thus, dietary
exposure is also possible from meat, milk and other animal products. The following is a summary
of tf|e, nature and magnitude of residues Hkely to be found in or on various food commodities, and
the methods used to detect those residues.
Plant Metabolism
The qualitative nature of the residue is adequately understood based on two studies with
[HC]triclopyr on grasses. The terminal residue of concern in/on grass and rice commodities is
triclopyr per se. No significant levels of the metabolites 3,5,6-trichlqrp-2-pyridinol (TCP) and 2-
memoxy-SjS^-trichlpropyridine were detected!
m | , Animal Metabolism
I HI II I ' ' ,'p : - Mill'
Adequate goat and poultry metabolism studies are available, the major residue in milk,
poultry and eggs is triclopyr per se. No significant levels of 2-methoxy-3,5,6-trichloropyridine
18
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were detected in an}' animal commodities. The metabolite 3,5,6-trichloro-2-pyridinol (TCP)
comprised a significant portion of the residue in meat, meat byproducts and fat but no significant
levels were detectable in any other animal commodities. .. ;
Residue Analytical Methods - Plants and Animals
' ' ' ' i ' :
Enforcement methods: Adequate methodology is available for the enforcement of
tolerances for triclopyr residues of concern in/on grass, rice and animal commodities. Two GC
methods (Methods I and n) with electron capture detection (GC/ECD) are available for the
determination of triclopyr residues of concern. Method I (Dow Chemical Co. Method ACR 77.4)
separately determines residues of triclopyr, 3,5,6-trichloro-2-pyridinol, and 2-methoxy-3,5,6-
trichloropyridine and has successfully undergone an Agency method validation using grass
commodities. The detection limits of Method I ranged from 0:01 to 1 ppm depending on the
compound being analyzed. Method E (Dow Chemical Co. Method ACR 77.2) determines
residues of triclopyr per .ye in milk, cream, and tissues, and has detection limits of 0.05-0.1 ppm.
Another GC/ECD method is available for the enforcement of tolerances of 3,5,6-trichloro-2-
pyridinol in meat; the method is listed in PAM Volume n as Method V under chlorpyrifos. All of
the above PAM II methods use diazomethane as a derivatizing.agent and benzene as a solvent. .
The Phase 4 Review stated that the registrant planned to revise the methods to substitute less
hazardous reagents. .
Data collection methods: Samples of grass commodities collected in response to
reregistration requirements were analyzed using Methods ACR 84.2 for triclopyr and ACR 84.4"
for 3,5,6Ttrichlorq-2-pyridinol. These methods differ slightly from the enforcement methods listed
in PAM Volume n, involving extraction with sodium hydroxide:water:methanol, but eliminating
the use of diazomethane and benzene. Method ACR 84.2 has undergone successful
radiovalidation using grass samples from the plant metabolism study.
Multiresidue methods: The FDAPESTD ATA database dated 1/94 (PAM Vol. I, . -. ,
Appendix I) indicates that triclopyr is completely recovered (>80%) using multiresidue method
PAM Vol. I Section 402. Data pertaining to multiresidue methods testing of triclopyr and its
metabolites through Protocols B, C, D, and E have been submitted and forwarded to FDA.-
Storage Stability
The available storage stability data are adequate for the ^registration of triclopyr uses on
grasses arid rice. Analytical data used in support of reregistration of triclopyr are supported by
available storage stability data^
Magnitude of the Residue in Plants
Adequate field trial data were submitted in conjunction with PP#1F03991 to support the
reregistration of the use on rice. . ;' -
19
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For the reregistration of triclopyr uses on grasses, the requirements for magnitude of the
residue in plants are fulfilled pending compliance by the registrant in adopting the required label
amendinents and tolerance revisions!
.fflU. i' I IF'"1 '' i,."1'1 " ;" ., I,'lil!!!' , I',1 ' :,, 'ป, 1 |! .,!,' '!' ,' ' ' i" !!' /' ,-, ,' ''' "' , '" , ' ' ,,!',
Adequate field trial .data, reflecting postemergence use of the registered 4 Ib ae/gal BEE
EC and 3 Ib ae/gal TEA SC/L formulations of triclopyr, are available from the original grass
tolerance petition (PP#1F2508); these data are sufficient to reassess the established tolerances for
an implication rate of 1 Ib ae/A. The existing tolerances of 500 ppm for triclopyr residues of
concern in/on grass forage and hay were established based on a maximum allowable rate of 1 Ib
ae/A. Adequate field trial data are not available in support of application rates higher than 1 Ib
ae/A.
I . 'i i,j'. iiii,|!iiiiuii i if ,i; i ' , ' IIP, , . ' ii '' ' j '! i '" ' i', , " ,i , ,. ',!"' ' ii<: , "
The available data indicate that the residues of triclopyr in/on grass forage collected
immediately (0-day) following a single postemergence application of a representative BEE or
TE^L trick>pyr formulation at 1 Ib ae/A are below 500 ppm. For comparison purposes, limited
field trial data reflecting application rates up to 9 Ib ae/A indicate that the maximum residues of
triclopyr in/on grass forage collected immediately (6-day posttreatment) were as high as 3333
ppin. The reassessed tolerance on grass forage will remain at 500 ppm; however, all labels must
be amended to reflect the available data that support this tolerance, i.e., the maximum yearly use
rate must be restricted to 1 Ib ae/A.
iซei : i For grass hay, the Agency allows the establishment of reasonable PHIs for the cutting of
the^hay. The available data indicate that the residues of triclopyr in/on grass hay collected 14 days
following a single postemergence application of a representative BEE or TEA triclopyr
formulation at 1 Ib ae/A will not exceed 200 ppm. The reassessed tolerance for grass hay is 200
ppm based on a 14-day PHI.
The Agency currently considers feeding restrictions and preharvest intervals (PHIs) to be
impractical for forage of pasture and rangeland grasses (Table n of the Pesticide Assessment
Guidelines, Subdivision O, Residue Chemistry, issued 9/95). Grass forage tolerances are set using
0-day posttreatment interval data. However, reasonable PHIs are allowed for the cutting of grass
hay. Accordingly, label amendments are required to remove all PHIs for grass forage and to
specify a 14-day PHI for grass hay, based on the reassessed tolerance for this commodity. The
established 3-day preslaughter interval must be retained. A restriction against grazing lactating
dairy animals until the next growing season, as currently found on triclopyr labels, must be
retained. All other grazing restrictions are unacceptable and must be removed from triclopyr
labels.
20
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Magnitude of the Residue in Processed Food/Feed
There are no processed food/feed items associated with triclopyr uses on grasses;
therefore, no grass processing data are required. An acceptable rice processing study has been.
submitted and evaluated in conjunction with a petition (PP#1F03991) for the establishment of
triclopyr tolerances for rice and poultry commodities. This study indicates that neither triclopyr
nor its TCP and 2-memoxy-3,5,6-trichloropyridine metabolites concentrate in rice processed
fractions. . . \ - .
' ' ' ' ' ' . - /'
Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
The requirements for'studies depicting magnitude* of the residue in milk, fat, meat, and
meat byproducts of livestock animals are fulfilled pending compliance by the registrant in adapting
the recommended label amendments and tolerance revisions/proposals. An acceptable poultry
feeding study has>been submitted and evaluated in conjunction with a petition (PP#1F03991) for
the establishment of triclopyr tolerances for rice and poultry commodities.
An acceptable dairy cattle feeding study has beeri submitted/evaluated in support of the
original grass tolerance petition (PP#1F2508). The existing tolerances for milk (0.01 ppm), for
fat, meat, meat byproducts except liver and kidney (0:05 ppm), andvfor liver and kidney (O'.S ppm)
are supported by these data provided the labels are amended to comply with the requirements
noted in this document. .
Nature and Magnitude of the Residue in Water, Fish and Irrigated Crops
Triclopyr is registered for use on rice. It is not currently registered for any other direct
use on water. However, data are currently under review in connection with PP#1F03935 for the
registration of triclopyr on aquatic sites. . -
Magnitude of the Residue in Food-Handling Establishments
Triclopyr is presently not registered for use in food-handling establishments; therefore, no
residue chemistry data are required under this guideline topic.
Confined/Field Rotational Crops
An adequate confined rotational crop study has been submitted to support the triclopyr
use on rice, including a rotational crop plant-back restriction of 4 months for all crops other than
rice. No further data are required in support of the existing label restriction.
21
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b. Dietary Exposure from Drinking Water
Tridopyr is not currently regulated under the Safe Drinking Water Act (SDWA),
therefore, a Maximum Contaminant Level (MCL) is not established. Public water supply systems
are not required to sample and analyze for triclopyr.
: A temporary Allowable Residue Level in Drinking Water (ARLDW) in potable water of
0.5 ppm was established under PP#6G3306 will expire in March of 1998. Petitions for the
registration of triclopyr in aquatic areas (PP#1F03935) are currently pending.
In accordance with the FQPA, the Agency is in the process of developing procedures and
methods for determining whether or not a pesticide is likely to be found in drinking water and, if
so, at what levels. Currently, hi order to assess the potential for drinking water exposure from
both ground water and surface water sources, EPA first considers the physical properties and
environmental ^fate ,gf the chemical and its ( metaboHtes, f EP^ also, considers available monitoring
data anci surface water modeling estimates. A more detailed discussion of the environmental fate,
monitoring data, and modeling results available for triclopyr can be found in section III.C.2.(c) of
this document.
It should be noted that the modeling results presented in section 331. C are worst-case
estimates of residues of triclopyr in pond waters, not in raw or finished drinking water. The
chronic (average) and acute (maximum) exposures calcuiated below using the model estimates are
not expected to occur in drinking water, but are presented as upper bound estimates for residues
of triclopyr in surface waters for use in calculating chronic and acute exposures and risks. Limited
surface water monitoring data presented in section III.C indicate that triclopyr residues may occur
in streams :trgate - .'. W T: '. :' .,"ซ' , i;.i.' ' : : . I . i ', ' ,
Chronic exposure (adult female) = 0.233 mg/L x 2 L/day *- 60 kg = 7.7 x 10"3 mg/kg/day
' ........... "i i ' I HEI ..... '.: ' ' Hi, , ' i ....... ir11,!'! " ! | : . ' , -"iUii1" i1- ', ', ...... "' :'\: ..... ... ........ i' ......... ,.,' , | i ^ ' i , ' '
Chronic exposure (child) = 0.233 mg/L x 1 L H-' 10 kg = 2.3 x 10'2 mg/kg/day
acute exposure for adult females and children calculated for use in the acute drinking
water risk equation is based on the maximum (peak) concentration of triclopyr residues from the
maximum application rate as estimated using the GENEEC model (364 ppb).
-------
, Acute exposure (adultfemale) = 0.364 mg/kg/day x 2.L/dayH- 60 kg = 1.2 x 10"2 mg/kg/day
Acute exposure (children) = 0.364 mg/kg/day x 1 L/day * 10 kg = 3.6 x 10"2 mg/kg/day
c. Occupational Exposure . r
Summary of Use Patterns and Formulations
Triclopyr is formulated as an emulsifiable concentrate (16.5 to 61.6 percent active
ingredient), a liquid-ready to use (13.6 to 16.7 percent active ingredient), a soluble concentrate
(32.5 percent active ingredient), a granular (0.18 to 0.5 percent active ingredient), and,as a
manufacturing product/liquid (61.6 to 96 percent active ingredient). Triclopyr is used for bark
treatment, broadcast, direct spray, foliar treatment, soil treatment, spot treatment and stump
.treatment. The following equipment is used to apply triclopyr: fixed-wing aircraft, helicopter,
hand held spray wand, hand held sprayer, knapsack sprayer, low volume sprayer, power sprayer, ,
groundb'oom sprayer, foliar pump sprayer, handgun, and hose-end sprayer.
Triclopyr is applied to the following sites:,terrestrial feed crops (e.g., pastures and
rangelands); terrestrial non-food sites (e.g., airports/landing fields, industrial areas, nonagricultural
outdoor buildings/structures, nonagricultural rightsrof-way/fencerows/hedge rows,
nonagricultural uncultivated areas/soils; recreational and outdoor residential (e.g., ornamental
lawns and turf); and forestry sites.: ' .-...'-
i . ' '-.-' .. . ' ' "
Occupational-use products and homeowner use products
' . ,'
' At this time, products containing triclopyr are-intended for both occupational uses and .
homeowner uses.. , ' .
Incident Reports s
A review of pesticide poisoning incident data was completed on June 26, 1996.
Numerous databases were searched for incident data for triclopyr (active ingredient 116001),
triethylamine triclopyr (active ingredient 116002), and triclopyr butoxy ethyl'ester (active
ingredient 116004). A literature review of possible human and animal adverse effects after ,
exposure to triclopyr was also conducted, although the available literature on these effects proved
to be scant. '
In summary, there were a total of 72 incident reports in the Incident Data System for
triclopyr (PC Codes 116001, 116002, and 116004); 42 reports involved humans, 20 domestic
animals and 10 environmental effects. The majority of the incidents resulted after exposure to
multiple pesticides and a causal relationship to triclopyr could not be established. Skin and eye
irritation were reported in approximately 12 humans either handling or exposed by drift to
triclopyr alone. Available evidence indicates that these effects were not severe and they are
. . : - . . 23 .-
-------
J!'l! illiiKI! Id' "i
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It,
consistent with the known toxicity of the chemical. The labeling for triclopyr products contains
warnings against contact with eyes and skin and these warnings must be retained on all products.
There were a total of 9 illnesses reported to the California Department of Pesticide
Regulation from 1982 through 1993 as a result of exposure to triclopyr alone. Seven were
incidents of eye or skin effects.
Triclopyr was Number 49 on the Top 200 Active Ingredients for which the National
Pesticide i;ele^omniunicatioiis Network (a toll-free information service supported by EPA's Office
of Pesticide Programs) received calls from 1982-1991. There were 624 calls reporting 125
incidents; 82 were in humans, 21 in animals and 22 others,.
Residential Exposure
siiii. = The Agency has determined that there are potential exposures to triclopyr during
application. These involve application of triclopyr-containing products by means of pump spray
t>01ll??> aeroso1 canง* squeeze bottles, "weed sticks," hose end sprayers, paint brush, rotary and
drop spreaders. It is unlikely that power sprayers would be used by homeowners. This sort of.
Special equipment is more apt to be used by agricultural or commercial applicators.
, Mi! > \ ' ," ,:K -, , '',.. <; . ..:'<,:"* ;';!ป,: - i- <',.,", ; . , wv^n ,
, . I1.!;;,, '... . , , .ซV'. . ! ' , ,
f:';!! The Agency does not believe that homeowner exposure or risk will be significant for the
following reasons: ,
iWii: rNo effects ..... of toxicplogical concern were observed at the highest dose tested (1000
mg/kg/day) ha a 21-day dermal toxicity study in rabbits. Dermal absorption is low (< 2%).
; * No significant toxicity resulting from inhalation exposure to triclopyr is expected. Both
triclopyr BEE (TGAI) and TEA (44.4% ai) are classified as Toxicity Category IV for effects via
the inhalation route of exposure.
-The percent ai in products intended for homeowner use is 1 ess than that in products
intended for agricultural and commercial use. Homeowner products range from 0.5 to 8.0% ai,
whereas products for the agricultural and commercial market range from 13.0 to 61.6% ai.
Application rates for homeowner products are 0.6 Ibs/ai/A or less, whereas typical agricultural
and cpmmercial rates range from 4-6 Ibs/ai/A.
, , .; ,,: ; , i . . , .
=:!ป ^All homeowner products are for outdoor use. Most homeowner product applications are
direged via spray or weed sticks (wand) at individual pest plants or limited areas. Only the 0.5%
ง5 granular product is applied by broadcast.
," r ii ...... i* , , ,,i,,ii,ii!'ii ..... ,!', i1 ,; 'inn " , , , ; ' .-' ,, '" i,h iiv , ,,,'!'i ' ',:';,'",!, M ,,,,!, i , . , " / v,ป 'I1, "
Because no toxicological endpoints of concern have been identified for short or
intermediate dermal or inhalation exposures to homeowners, no exposure or risk assessments
24
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have been conducted:, No chronic exposure is anticipated for homeowner use of triclopyr .
products. - , .
Occupational Mixer/Loader/Applicator Exposure
EPA has determined that there are potential exposures to mixers, loaders,'applicators, or
..other handlers during usual use-patterns associated with triclopyr. Based on the use patterns.12
major exposure scenarios were identified for triclopyr: (la) mixing/loading liquids for aerial
application; (Ib) mixing/loading liquids for groundboom and handgun application; (2) aerial;
application of liquids (fixed-wing); (3) aerial application of liquids (helicopter); (4) groundboom
application of liquids; (5) handgun sprayer application of liquids; (6) mixing/loading/applying , .,
liquids with a backpack sprayer; (7) mixing/loading/applying liquids with a low pressure
handwand; (8) applying liquids with an aerosol can; (9) mixing/loading/applying granulars with a -
push-type spreader; (10) mixing/loading/applying liquids with a hand pump sprayer; (11)
mixing/loading/applying liquid with a hose-end sprayer; and, (12) flagging for liquid aerial
applications. - , . ' ,"-... ; .
Short-term and intermediate-term dermal and inhalation exposure assessments are not
required because there are no toxi cological endpoints of concern. At this time,, no chroni c ri sk
assessment is required for handler exposures to triclopyr, since none of the current handler
exposure scenarios is likely to result in chronic exposure. .-'-.- . ;
Post-Application/Reentry Exposure
EPA has determined that there are potential exposures to persons entering treated sites :
after application is complete. These include exposures (1) to persons, including children, in
recreational (playground) and residential turfgrass areas (2) to workers and other persons in
commercial forests, and (3) to workers and other persons in rights-of-ways and other non-crop
areas. Because of the toxicological characteristics of triclopyr (very low dermal, and inhalation
toxi city), EPA has determined that a post-application exposure assessment is not warranted at this
time.
However, it should be noted that EPA Region 9 is working with the California
Department of Pesticide Regulation, the US Forest Service and Native American tribes in
California to determine'the potential exposure to forestry herbicides, including triclopyr, that may
be occuring to Native Americans through their use of forest plant materials. Native Americans :
use these plant materials in their diets, in the making of traditional basketry, for medicinal
purposes, and in ceremonial activities. Phase one of the joint project developed sampling and -
analytical methodologies. Phase two will determine the dissipation rate and frequency of
occurrence of three herbicides (glyphosate, hexazinone, and triclopyr) in plants of interest to
Native Americans. The objective of mis joint effort is to characterize these unique'exposure.
scenarios which, be'cause of their unique and localized nature, are not reflected in the current
assessment. .
25
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!{.: .
SIC'! '. .. . i LI'
Restricted-Entry Intervals (REIs) for all uses within the scope of the WPS are based on
the acute toxicity of the active ingredient. The toxicity categories of the active ingredient forthe
dermal toxicity, eye irritation potential, and skin irritation potential are used in determining the
WPS REI. If one or more of the three acute toxicity effects are in the Toxicity Category I, the .
REI is established at 48 hours. If none of the acute toxicity effects are in category I, but one or
more of the three is classified as category II, the REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or it, the interim REI is established at 12 hours.
Interim REIs establishedfor jriclopyr-containing products range from 12 to 48 hours. As noted
in IK Notice ^3-^~LabeHng Revisions Required by the Worker Protection Standard. EPA
Considers, during the reregistration process, all relevant active ingredient and product-specific
information to, "decjjfe Aether there is reason to shorten or lengthen the previously established
REL The REI for triclopyr is further addressed in Section IV of this document.
* -i:,1"!: ' i" r1 i1' ,;" ซi! i j , ', m,' ,, l|:' i'" i ," " '', irii1,""1 : / l;,, \ r ,'. " '"v1 i '.' {!;"ป' i . ':' i
4. Risk Characterization
(ill!""i 1, . , 'V " "1 :im\ , ' ' " i; ป ' . ,': 'i1,,:1 ,,' ' / ',. ' ' : V| ' '''!!'' I '! ''
a. Dietary Risk
i 1;!' ".' ':' "i ' '"P . " : \ r . ;' .,:.. " 1 i. ' "' ': '" ' ' ' '
Chronic Dietary Risk using TMRC
A chronic exposure analysis was performed using tolerance level residues and 100 percent
crop treated information to estimate the Theoretical Maximum Residue Contribution (TMRC) for
the general population and 22 subgroups.
"; Existing tolerances result in a TMRC which represents 0.81% of the RfD for the U.S.
general population. The sub population with the highest potential exposure, non-nursing Infants
(<1 year old) occupies 2.65% of the RfD. .
The chronic analysis for triclopyr is a worst case estimate of dietary exposure calculated .
with all residues at tolerance level and 100 percent of the commodities assumed to be treated with
"i!,!,, ' :!, , ' ' / ii'vy iir,,1,, L -,i*i:: '''i ,"",i,''i" "::; ปi. n * , .
triclopyr. Because the percent of the RfD occupied is far below 100, even using worst case
exfbsure assumptions, EPA considers the chronic dietary risk of triclopyr from food sources to be
minimal.
v",1 .. t . ' " *' .i.,ii", "'' - :, i / " ' ;' ' . ., : i1 .'.. i i ' , \
Acute Dietary Risk
' S, ' - "' ' . ', <*; !.' . . '',"'; - ' ".'.. :' -. '<,.''" ';:, '" ' .'.
. fi; >:; . ":.- %. f , . ;-,:'. >;> :'.: .:.'!<::' ; ':,,;!.,;> ->!-:; ' >"?'.;. ; . ; ' ; ' . ' '
is ; Since the tpxicological endpoint to which exposure is being compared in this analysis is a
developmental NOEL (30 mg/kg/day), pregnant females (13+ years) is the sub-population of
particular interest.
The Margin of Exposure (MOE) is a measure of how close the high end exposure comes
to the NOEL (the highest dose at which no effects were observed in the laboratory test), and is
calculated as the ratio of the NOEL to the exposure (NOEL/exposure = MOE). Generally, acute
dietary margins of exposure greater than 100 present no dietary concern. The high end MOE
-------
value of 2500 (see below) is within the acceptable range and demonstrates no acute dietary
concern. , .' '
Pregnant Females (13+ Years):
Where RDV = relative dose value >'.'',
and X = estimated 'percentage of population user-days with residue contribution exceeding X
times the RDV. . , . , ' >
Exposure = RDV x; X . ",-
= 0.01x1.2 , -' ;.
High End Exposure = 0.012 mg/kg/day
, MOE = NOEL/exposure . ' ' , .
='30.0 mg/kg/day/0.012 mg/kg/day ' " . .
MOE = 2500 ' . L; . '-'_' - ... .' ' ' .. '
b. Drinking Water Risk
The calculations presented below are based on an icuteJSfOEL = 30 mg/kg/day, and a
. chronic NOEL = 5 mg/kg/day. The.Reference Dose has been established as 0.05 mg/kg/dayl
Chronic Drinking Water Risk ' '
\ : ' - ' ' , ' ' '
For a 10 kg child consuming 1 Liter of water a day the chronic drinking water risk is calculated as
a percent of the RfD: " , .
Percent of RfD = (2.3 x 10"2 mg/kg/day -^ 0.05 mg/kg/day) X 100 = 46% . . ,. " '-'\
For a .60 kg pregnant female consuming 2 Liters of water a day the chronic drinking water risk is
calculated as a percent of the RfD:
/ . )
Percent of RfD = (7.7 x lO'3 mg/kg/day -^ 0.05 mg/kg/day) X'100 =15% , . ;
Acute Drinking Water Risk . '..>." '
For a 10 kg child consuming 1 Liter of water a day the acute drinking water riskjs calculated as a
Margin'of Exposure (MOE): .."'.' ,
MOE =-3'0 mg/kg/day - 3.6,x~ 10'2 mg/kg/day = ,825
.For-a 60 kg pregnant female consuming 2 Liters of water a day the acute drinking water risk is
calculated as a MOE:
27
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MOB = 30 mg/kg/day '* 1.2 x 10'2 mg/kg/day = 2,500
c. Occupational Risk
SJsk From Handler Exposures
Short-term and Intermediate-term Risk: No short- or intermediate-term risk
assessment was required for handler exposures to triclopyr because no toxicological endpoints of
concern were idenSled in a 21 day dermal toxicity study in rabbits at the highest dose (1000
T I'BIIMI , ' , ; ' I II.' , ,!, '" ,' '. "i'l!" i! ./-:., , ., i, i. , ,. r :. r :: , .,>. ... " . V
ml/kg/day) indicating very low toxicity via the dermal route of exposure. Furthermore., no
significant toxicity is expected from inhalation exposure. .
'.it ." ' illllllll;! I'. I " ,',,' . "" .,, II'! ' .". , i "."..| l\ ; ., '[ 1, " : .'... ,;,'': I ., > '.
Chronic Risk: At this time, no chronic risk assessment is required for handler exposures
to triclopyr, since none of the current handler exposure scenarios is likely to result in chronic
exposure.
'", .' .';";',; , '"..' . "'i'1 " ., .. ;,; " - " '' ':' .. ' '?''' j . . ' '
Risk From Post-Application Exposures
,, Short-term and Inter mediate-term Risk; No short- or intermediate-term risk
assessment was required for post-application exposures to triclopyr because there are no
toxicoiogical endpoints of concern identified at.this time.
Chronic Risk: At this time, no chronic risk assessment is required for post-application
exposures to triclopyr, since none of the current post-application exposure scenarios is likely to
result in chronic exposure.
Additional Occupational/Residential Exposure Studies
Handler Studies
( Handler exposure studies are not required at this time, since there are no toxicological
endpoints of concern identified at this time.
Post-Application Studies .
Post-application exposure studies are not required at this time, since there are no
toxicological endpoints of concern identified at this time.
d. FQPA Considerations
The Food Duality Protection Act of 1996 (FQPA) amended the FFDCA by setting, a new
safety standard for the establishment of tolerances. In determining whether a tolerance meets the
new safety standard, section 408(b)(2)(C) directs EPA to consider information concerning the
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susceptibility of infants and children to pesticide residues in food, and available information
concerning aggregate exposure to infants and children of such residues, as well as the potential for
cumulative effects from pesticide residues and other substances that have a common mechanism
of toxicity. . . , ,
The FQPA amendments to, section 408(b)(2)(C) require EPA to apply an uncertainty
(safety) factor of up to 10 fold, unless reliable data demonstrate that a lesser uncertainty factor
will be sufficiently protective of infants and children. . ^
Section 408(b)(2)(D) establishes factors that the Agency must consider in determining
whether the safety standard is met in deciding to issue or reassess tolerances. These factors
include the consideration of available information on the aggregate exposures to the pesticide
from dietary sources including drinking water as well as lion-occupational exposures such as
those derived from pesticides used in and around the home. The Agency must also consider the
potential cumulative effects of the pesticide for which a tolerance is being sought and other
substances that have a common mechanism of toxicity.
Potential Risk to Infants and Children ,
In determining what safety factor is appropriate for assessing risks to infants and children,
.EPA considers all available reliable data and makes a decision using a weight-of-eviden.ce ,
approach. This approach takes into account the completeness and adequacy of the toxicity data
base, the nature of the effects observed in pre- and post-natal studies, and other information such
as epidemiological data. ;
For the purpose of assessing the pre- and post-natal toxicity of triclopyr, EPA has
evaluated three developmental and one reproduction study. The results of these studies are . ,
reported in Section ni.B.e: and ni.B.f. Based on current data requirements, these studies when
considered along with other required toxicity studies, constitute a complete data base for
evaluating pre- and post-natal effects for triclopyr. However, as EPA fully implements the ,
requirements of FQPA, additional data related to the special sensitivity of young organisms'may
be required.
The developmental and reproductive data for triclopyr indicate that developmental and
reproductive effects occurred only at doses that are the sam e as or higher than doses which
caused maternal or parental effects. Generally, the Agency would be concerned when
developmental/reproductive effects are seen at doses lower than those that cause maternal effects.
. Based on reliable data indicating no special sensitivity of young organisms to triclopyr, the
Agency concludes that an uncertainly factor of 100 is adequate for the triclopyr chronic and acute
risk assessments. . ' .
Aggregate Exposure/Risk ^ . . - .
-------
llf
";!,*'
In examining aggregate risk, FQPA directs EPA to take into account available information
coggerning exposures from the pesticide residue in food and all other exposures for which there is
re}i|t)le information,; These other sources of exposure include drinking water, and exposure from
us|| in and around the home. Triclopyr shares a common metabolite^ TCP, with the insecticide
chlorpyrifos. EPA has assessed the combined likely exposures to TCP from both triclopyr and
chlorpyrifos (below) using very high exposure assumptions, and found no risks of concern.
: [.,, i , , "":: '* jmi," , ' 'i , * '' ,i" , ' i, ' "-', '""" ,, i, , , i ,-,,,. V , i'
.lia/'i " "' i - ,' ' , I ..I'llliM,,,, i , ,' "' , i , i , ., ,ii,< ' ' : i'jiซ; ' ; ,, ,:;: "vi . : iii, i.,. " : , , ' ' 'I,!'11!'1" ' ;l In , , > , ',
Because triclopyr has food uses, specific consideration of potential risks to infants and
children, as well as cumulative and aggregate exposures, is warranted.
Aggregate Risk
Because of the toxicological characteristics of triclopyr (no dermal endpoint of concern
identified at this time), EPA determined that a post-application exposure assessment was not
necessary. Residential exposure is considered to be negligible (no dermal endpoint of concern .
identified at this time). Therefore, no significant non-occupational exposure is expected.
Exposure levels to triclopyr based on upper bound estimates of triclopyr residues in
surface wajersDerivedfrom.modeling are not expected to occur in drinking water. They are
presented here to indicate that even hi the most extreme circumstances, the total risk associated
with triclopyr residues in the diet (food + water) is below the Agency's level of concern. By
comparison, exposures to triclopyr based on available ground water monitoring data result in
chronic drinking water risks <1% of the RfD (for adults and children), and an acute MOE
>1,000,000 for females, 13+ years.
Acute Aggregate Risk
The acute aggregate dietary MOE includes potential exposure to triclopyr in food and
drinking water. It is calculated below for females 13+ years. The MOE calculation is based on a
maternal NOEL of 30 mg/kg/day selected from a developmental study in rabbits for use in acute
dietary risk calculations. Because the endpoint selected for acute dietary exposure and risk is from
a developmental study and is a maternal NOEL., the sub-population, females 13+ years, is the
sii^^oup^ofinterest^and the subject of the acute aggregate risk calculations below. The aggregate
acufe dietary MOE was calculated to be 1250. This risk assessment assumed 100% crop treated
wit| |oler|nce level residues on all treated crops consumed, and an upper bound estimate of
triclopyr residues in drinking water, resulting in a significant over-estimate of dietary exposure.
Th^ high acute aggregate dietary MOE provides assurance that there is a reasonable certainty of
no harm for the sub-population of females 13+ years as well as the general population including
infants and children.
' i iiiiii-i 'i . " ' '.!,.. ;."iffl , i.1 . ' ป .'.,';/ '> ""< ,'. li1'.;,' " ' .) ,i ',,''.' .' ";, '. ',' >,, i" - . '.' '
13+ Pregnant Females Dietary + Drinking Water
30
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Acute aggregate exposure = 0.012 mg/kg/day (food) + 0.012 mg/kg/day (water) = 0.024
mg/kg/day . - ' , _ ,,
Acute MOE (aggregate) = 30'mg/kg/day + 2.4 10"2 mg/kg/day = 1250
Chronic Aggregate Risk
Using the conservative exposure assumptions described above, the Agency finds that the
percentage of the RfD that will be utilized by aggregate exposure to residues of triclopyr for the
sub-population, females 13+ years approximates 16% and for the sub-population, non-nursing
infants (< 1 year old) approximates 49%.
Females 13+ years (pregnant) Dietary + Drinking Water.
' , , . ' .,..'
Percent of RfD (food) = 0.0003 mg/kg/day -5- 0.05 mg/kg/day x 100 = 0.6% RfD - '.
Percent of RfD (water) = (7.7 x 10'3 mg/kg/day - 0.05) X 100 =15% RfD
Chronic aggregate exposure = 0.6% (food) + 15% (water) = 15.6% RfD
Non-Nursing Infants (< 1 year old)
Percent of RfD (food) = 0.0013 mg/kg/day * 0.05 mg/kg/day x 100 = 2.6% RfD
Percent of RfD (water) = 2.3 x 10-2 mg/kg/day-^ 0.05 mg/kg/day) X 10,0 = 46% RfD
f ' -' > " ,- .
Chronic aggregate exposure = 2.6% (food) + 46% (water) = 48.6% RfD
Aggregate Risk from TCP
Triclopyr shares a common metabolite, 3,5,6-trichloro-2-pyridmol (TCP), with the
insecticide chlorpyrifos. EPA's assessment of the likely exposure and risks associated with TCP
follows. ., , '
Toxicity Endpoints >
TCP is comparable in toxicity to triclopyr. Whereas the acute toxicity endpoint for
triclopyr is 30 mg/kg/day based on a developmental study, the acute toxicity endpoint for TCP is
25 mg/kg/day, also based on a developmental study (Redden 9/97).
The chronic endpoint for triclopyr is the RfD of 0.05 mg/kg/day based on a reproductive
study in rats. A RfD has not been set for TCP but for purposes of this risk assessment, EPA
proposes that a provisional RfD of 0.03 mg/kg/day be used based on 'a 1 -year dog study with a
'." ' ' ' .31- ' . , - '
-------
JL of 3 mg/kg/day (Redden 9/97) and an uncertainty factor of 100 for intra and interspecies
variability. This RfD is 10-fold higher than the RfD of 0.003 mg/kg/day for chlorpyrifos based on
cholinesterase inhibition.
ii 'ป ,i , , 'Wl'i " "',!' ., , , ' , :, ' "',,,','
Acute Exposure
No DRES runs have been done for TCP, however, the DRES runs for tricldpyr and
chlorpyrifos can be used for this analysis. The DRES run for triclopyr indicates that 2:99.5% of
females (13+ years) are exposed to 0.012 mg/kg/day or less. The triclopyr run assumes 100%
crop treated and all residues at tolerance levels. If we assume that all triclopyr residues could be
converted to TCP (clearly a worse case assumption since TCP is considered a significant
component of the residue only in meat and meat byproducts), acute dietary exposure to TCP from
use of triclopyr is highly unlikely to exceed 0.012 mg/kg/day.
From the chlorpyrifos DRES run, ฃ99.5% of females (13+ years) are exposed to 0.016
mg^kg/day or less of chlorpyrifos. The chlorpyrifos run made use of percent crop treated and
anticipated residue information to generate a more realistic estimate of dietary exposure to .
chlorpyrifos. Assuming that all chlorpyrifos residues would be converted to TCP prior to
consumption1, acute dietary exposure to TCP from all uses of chlorpyrifos is not likely to exceed
0.016 mg/feg/day.
Realistic estimates of TCP in drinking water from use of triclopyr and chlorpyrifos are not
available. Based on modeling, an upper bound estimate of acute drinking water exposure to
triclopyr of 0.012 mg/kg/day was done for the triclopyr RED (Eiden 7/7/97). Assuming as we did
above that all triclopyr in drinking water is hydrolyzed to TCP prior to consumption, the upper
bound estimate of acute drinking water exposure to TCP is 0.012 mg/kg/day.
From the draft chlorpyrifos RED, the highest level of chlorpyrifos found in drinking water
was 2 ppm in a well associated with a house treated for termites. There is no way to know how
high TCP levels might have been under these conditions (the half-life for hydrolysis of
chlorpyrifos to TCP ranges from 4-10 weeks) without direct monitoring, but TCP levels could
possibly be higher than chlorpyrifos levels. If TCP levels were at 2 ppm, the corresponding dose
would be 0.0067 mg/kg/day.
:.'! For residential uses of chlorpyrifos, no data are available to estimate potential exposures
to TCP.
1 A toleranqe reassessment for chlorpyrifos was performed at some time after TCP was
removed from the tolerance expression for those commodities where TCP residues could be
distinguished from chlorpyrifos residues. It is apparent from the reassessment that TCP was
usually not the major component of the total residue (Knizner 9/15/94). Therefore, using
chlorpyrifos residues as a surrogate for TCP residues is unlikely to underestimate residues of TCP
in commodities.
. " .32
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Acute Aggregate Risk
Acute dietary exposure to TCP resulting from triclopyr use is unlikely to exceed 0.012
mg/kg/day, and acute dietary exposure to TCP from chlorpyrifos is unlikely to exceed 0.016
mg/kg/day. Combined dietary exposure is unlikely to exceed 0.028 mg/kg/day and the
corresponding MOE is 25 mg/kg/day f Q.028 mg/kg/day or s900.
If the upper bound estimate of 0.012'mg/kg/day for acute drinking water exposure to TCP
from uses of triclopyr is added to the dietary estimate, the combined exposure is 0.040 ;
mg/kg/day and the MOE is z 600. ' . . '
An estimate for acute drinking water .exposure to TCP from uses of chlorpyrifos is not
feasible; however, residues of TCP in drinking water from uses of chlorpyrifos would have to
exceed 6 ppm for the MOE to be less than the recommended 100. Based on the water monitoring
data for chlorpyrifos, this is likely to be a rare event.
Chronic Exposure and Risk
The DRES run for triclopyr indicates that for non-nursing infants <1 year old, chronic
dietary exposure to triclopyr is equivalent to 2.65% of the RfD of 0:05 mg/kg/day or 0.001325
mg/fcg/day. Using the worst case assumption that all triclopyr residues could be converted to
TCP, then for non-nursing infants <1 year old, chronic dietary exposure to TCP from uses of :
triclopyr would occupy 4.4% of the provisional TCP RfD of 0.03 mg/kg/day.
The' DRES run for chlorpyrifos indicates that for non-nursing infants <1 year old, chronic
dietary exposure to chlorpyrifos and TCP (before TCP was removed from the tolerance
expression for some commodities) is equivalent to 91 % of the RfD of 0.003 mg/kg/day or
0.002'73 mg/kg/day. Assuming that the total residue was converted to TCP prior to ingestion
then for non-nursing infants <1 year old, chronic dietary exposure to TCP from uses of . -
chlorpyrifos would occupy'9.1% of the provisional TCP RfD of 0.03 mg/kg/day.
For non-nursing infants <1 year old, total chronic dietary exposure is unlikely to exceed
4A% plus 9.1% or 13.5% of the provisional RfD for TCP. Based on a GENEEC estimate for
non-nursing infants < 1 year old (Eiden 7/7/97), chronic drinking water exposure to triclopyr was '
estimated to be 0.023 mg/kg/day. For non-nursing infants <1 year old, total chronic exposure
from'diet and drinking water is 0.023 + 0.00273 + 0.001325 mg/kg/day or 0.027 mg/kg/day or -
90% of the provisional RfD. Possible chronic drinking water exposure to TCP from use of
chlorpyrifos has not been included in the calculation because there are no supporting data.
Qualitatively, it is conceivable that termiticide use of chlorpyrifos may result in chronic drinking
water exposures to TCP that exceed the provisional RfD but this situation is not likely to be
common. ' ' ' . .
33
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Based on its analysis, the Agency concludes that the existing uses of triclopyr and
chlorpyrifos are unlikely to result in acute or chronic dietary risks from TCP. Based on limited
available data and modeling estimates, with less certainty, the Agency concludes that existing uses
of triclopyr and chlorpyrifos are unlikely to result in acute or chronic drinking w.ater risks from
TCP, Acute and chronic aggregate risks of concern are also unlikely to result from existing uses
of triclopyr and chlorpyrifos.
A ;.:: i, : ii-i'i , i, ' i. ,(1, , - .' '.:. :. .. . . ; , , ; , > : f, . -..
Potentially me greatest (and least certain) source of exposure to TCP is from drinking
water associated with use of chlorpyrifos as a termiticide. Risks associated with this use will be
considered in the chlorpyrifos RED. Additional restrictions on the use of triclopyr are unlikely to
have any effect in reducing aggregate risk from TCP.
Cumulative Effects
Section 4p8(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency believes that "available
information" in this context might include not only toxicity, chemistry, and exposure data, but also
Scientific policies and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances,. EPA does not at this
time, have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this issue
further through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot/process will increase the Agency's scientific understanding of this question
such that EPA will be able to develop and apply scientific principles for better determining' which
chemicals have a common mechanism of toxicity and evaluating the cumulative effects of such
chemicals. The Agency anticipates, however, that even as its understanding of the science of
common mechanisms increases., decisions on specific classes ofchemicals will be heavily
dependent on chemical specific data, much of which may not be presently available.
!"' Triclopyr shares a common metabolite, TCP, with the insecticide chlorpyrifos. EPA has
assessed the combined likely exposures to TCP from both triclopyr and chlorpyrifos (above) using
very high exposure assumptions, and found no risks of concern.
Additionally, DowElanco has submitted information to the Agency comparing the
chemical structure and toxicity of triclopyr to other related compounds including'another
pyridinyloxyacetic acid, fluroxypyr and two pyridinecarboxylic acids,, clopyralid and picloram
(MRJD 44385901). However, at this time the Agency has not yet made a final decision
concerning a possible mechanism of toxicity for triclopyr and other compounds. Therefore, for
34
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the purposes of the tolerance reassessments in this RED document, EPA has performed risk
assessments for triclopyr and TCP only. .. -
C. Environmental Assessment
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute ' '
An acute oral toxicity study using the technical grade, of the -active ingredient is required to
establish the toxicity of a pesticide to birds. The preferred test species is either mallard duck or
bobwhite quail. Results of this test are tabulated below.
Table 5: Avian Acute Oral Toxicity -Triclopyr Acid
Species -- -,'
Mallard Duck
(Anasplatyrhynchus)
%-AI,
technical
H3SB
(mg&g)
1,698
toxieity
Category
slightly toxic
MfclDJfc.
Atithor/Year ,
40346401
Dow Chemical/1 976
fyliills.pปi^be^ ;
ReguSmpfiat
yes (core)
These results indicate that triclopyr acid is slightly toxic to avian species on an acute oral
basis. The guideline requirement (71-1) is fulfilled '(MRID # 40346401).
Table 6: Avian Acute Oral Toxicity-Triclopyr Triethylamine (TEA)
" Speeias
Mallard Duck
(Anas platyrhynchys)
%AJL- '
64.7
U>^<
Wg)
20551 .
ToxTfcity ;
Category j
, practically .
non-toxic
.., MyDNo.
"AatiOr/Year
40346501
'Fink/1978
"-" ' Fialgls Guideline
Requirements
V * ' '
yes (core)
1 This a.i. value is from 3176 mg/kg x 64.7% formulation.
These results indicate that triclopyr - triethylamine (TEA) is practically non-toxic to
slightly toxic to avian species on an acute oral basis. The guideline requirement (71-1) is fulfilled
(MRID# 40346501). . ' ' " .
35
-------
Table 7: Avian Acute Oral Toxicity -Triclopyr Butoxyethyl Ester (BEE)
11 ! !!! v ซ
Species
Vjป "
t ' ^ , ป"V "i( '
! ' i'i I"' i o ,i v i t.
Northern Bobwhite Quail
(Colinus virginianus)
Northern Bobwhite Quail
(Colinus virginiamis)
* AX ;
-, ,* ^ j. ซ ,
^ y ^ ** '
96.1
62.9
' V IA.
735
849'
foxkaiy
_ Category
slightly toxic
slightly toxic
-MB|DJ^
Actbor/fear
41902002
41902003
; MfiJJs
; OuKJelme-
llecpir-enjeGfe
yes (core)
yes (core)
1 This ti. value is from 1350 mg/kg x 62.9% formulation.
: :;;:| These results indicate that triclopyr - butoxyethyl ester (BEE) is slightly toxic to avian
species on an acute oral basis. The guideline requirement (71-1) is fulfilled (MEOD # 41902003).
Data on the toxicity of the triclopyr degradate, 3,5,6-tricloro-2-pyridmol (TCP) to wildlife, are
cogently being reviewed in the context of the chlorpyrifos RED since TCP is also a degradate of
ch|orpyrifos. These data indicate that TCP is slightly toxic or practically non-toxic acutely to the
bird species tested.
Two subacute dietary studies using the technical grade of the active ingredient are
required to establish the toxicity of a pesticide to birds. The preferred test species are mallard
duck (a waterfowl) and bob white quail (an upland gamebird). Results of these tests are tabulated
below. .
Table 8: Avian Subacute Dietary Toxicity - Triclopyr Acid
-J ".
SJWJAS , s
^ ^ >
( << -. i ^ >
Cortunix Quail
Northern Bobwhite Quail
(Colinus virginfanus)
Mallard Duck
(Anas platyrJiynchus)
%M
technical
technical
99.0
iC^o (ppui)
3,272
2,934
5,620
ToXicjjy
Category
slightly toxic
slightly toxic
practically non-
toxic
\ MRIDNo,
Aether/Year
00049638
Dow
Chemical/1973
40346403
DOW
Chemical/1976
0031249
Wildlife
Int'1/1979
FMiat
(juideline
Reqairetaซnts
no,
supplemental
yes (core)
yes (core)
i;; These resultsi indicate that triclopyr acid.is slightly toxic to practically non-toxic to avian
species on a subacute dietary basis. The guideline requirement 71-2 is fulfilled (MRJD # 0031249
and 40346403).
36
-------
Table 9: Avian Subacute Dietary Toxicity-Triclopyr TEA
> f AV s
Species", ," '
Northern Bobwhite Quail
(C olinus virginianus) ,
Mallard Duck
(Anas platyrhynchus)
" %AX
64.7
.64.7
LC3fl.|ppm)J
11,622
>10,000
Toxiedty
Category
practically non-
. toxic
practically non-
toxic
MRIDNo,
Aathof/Year
403^6503
Fink/1978
40346502
Fink/1977
Fulfills
Gttideljbs
Regoirscaents
yes (core)
yes (core) -
These results indicate that triclopyr TEA is practically non-toxic to avian species on a
subacute dietary basis. The guideline requirement 71-2 is fulfilled (MRIL>.# 40346503,
40346502). ' . .. ,
Table 10: Avian Subacute Dietary Toxicity Triclopyr Butoxyethyl Ester (BEE)
Spaci^is -
^ f** y$ *" * * f
Northern Bobwhite Quail
(Colinus virginiahm)
. Northern Bobwhite Quail
(Colinus virginianus)
Mallard Duck
(Anas platyrhynchus)
Mallard Duck ,
(Anas platyrhynchus)
%Li, ,
93
96.1. /
93 , ,
96.1
LCjoCppm)
9026
. 5401
;, >io,ooo
>55401 '
Tosbity
,, Category
practically non-
toxic
- practically non-
toxic
practically non- '
toxic
practically non-..
toxic
'MMDNo/
: AutW/Tear
"" v- f
00134180
Wildlife
Int'1/1978
41905501
Lynn/1991
00134179
Wildlife
Int'I/1977
41905502
Lynn/1991
,, - FuffiLls" ^
OaMen'ae "'
^jRequjrejnejils-
yes (core)
yes (core)
yes" (core)
yes (core)
These results indicate that triclopyr BEE is practically non-toxic to avian species on a
subacute dietary basis. The guideline requirement 71-2 is fulfilled (MRED # 41905501,
41905502, 00134179, 00134180). Available data on the.degradate TCP suggest low toxicity to
birds on a subacute dietary.basis. ;
(2)
Birds, Chronic
Avian reproduction studies ,are required for triclopyr because: (1) birds may be subject to
repeated or continuous exposure to the pesticide, especially preceding or during the breeding
season; (2) the pesticide is stable in the environment to the extent that potentially toxic amounts
may persist in animal feed; (t1/2 of 8 to 18 days).' Results of these tests are tabulated below.
37'
-------
Table 11: Avian Reproduction - Triclopyr Acid
Species
hi
Northern Bobwhite Quail
(Colinus virginlanus)
Mallard Duck
(Anas platyrhynchus)
%Aฃ
98.9
. 98.9
&OBC/L0EC
f Xppin.}
NOEC 500
LOEO500
NOEC 100
LOEC 200
Badpoints
- AUbeted
N/A
number of 14 day
old survivors
MRIDHo, , ,
Author/Year
00031251
Beavers/1979
00031250
Beavers/1979
FoM5<3wซMuป
R-eqairefflsnt? .
yes (core)
yes (core)
Base.,,,'' ' 'ป> /'"-.
Acute oral LD50
Two-Generation Reproduction
Study Guideline (83-4)
\ x Badpoiat
i "
-------
(4) Insects
A honey bee acute contact study using the technical grade of the active ingredient is
required if the proposed'use will result in honey bee exposure. Results of this test are tabulated
below. , , ,
Table 13: Nontarget Insect Acute Contact Toxicity-Triclopyr Acid
.Species
, <
_.
Honey Bee
(Apis me Hi/era)
%A.I,
99.2
LDxo.Cwg/tee)
l
,>100 .
Toxieity Category
practically non-toxip
1 MRIBNo. r -
; Aaifaor/Yesr
' * "" s
40356602 ' ,
Dingledine/1985 ,
' FulfiOs.
Gajdeliije "
Reiqujri^JJient!?
yes (core)
The results indicate that triclopyr acid is practically non-toxic to bees on an acute contact
basis. The guideline requirement (141-1) is fulfilled (3VERID # 40356602). .
Table 14; Nontarget Insect Acute, Contact Toxicjty Triclopyr TEA
\ " c
' Species" s
Honey Bee
(Apis mellifera)
S4A.J,
f * :
99.2
XAa
(M^bee)
>100
Toxici
'practically non-toxic
MRlDMo.
Autiior/Yeai?
f ' *
40356602 -
Dingledine/1985
- FiflMs-
Gmdelae^
Reqairemersts .
yes (core)
The results indicate that triclopyr TEA is relatively non-toxic to.bees on an acute contact
basis. The guideline requirement (141-1) is fulfilled (MRID # 40356602). .
b. , Toxicity to Aquatic Animals ;
(1) Freshwater Fish, Acute
Two freshwater fish toxicity studies using the technical grade of the active ingredient are
required to establish the toxicity of a pesticide to fish. -The preferred test species are rainbow
trout (a cold-water fish) and bluegill sunfish (a warmwater fish). Results of these tests are
tabulated below. '
39
-------
Table 15: Freshwater Fish Acute Toxicity TricJopyr Acid
1 ' Species
Illlllll l|l 11 II 1 > II IHtt
111 1 II II 1 ( f ซJป
ill 1 1 1 * ft f -t < ''I
1 |l| 1 11 11 I ป 1ซ
Rainbow trout
(Oncortynchus
myJdss)
Bluegillsunfish
(Lepomis
macrochinis)
%AX' :
v-.-".^^^ ,
_Jซ f J '
technical
(Dowco 233)
technical
(Dowco 233)
iAjj-0
,
Rainbow trout
(Oncorhynchus mykiss)
Rainbow
teov&(Oncor}iynchus
mykiss)
Bluegill sunfish
(Lepomis macrochinis)
Blucgil] sunfish
(Lepomis maci-ochirus)
Fathead minnow
(Pimephales promelas)
Fathead minnow
(Pimephales promelas)
Fathead minnow
(Pimephales promelas)
%At
; fc' % ''
64.7
47.8
(M3724)
64.7
47.8
(M3724)
64.7
44.9
44.9
tt^fcpotf
613
(flow-
through)
240
. (flow-
lirough)
893
(flow-
through)
471
(flow-
through)
947
(flow-
through)
544
(static)
279
(flow-
through)
! T&aejrf
; Categorj'
practically
non-toxic
practically
non-toxic
practically
^on-toxic
practicalty
non-toxic
practically
non-toxic
practically
non-toxic
practically
non-toxic
M8m3%
Aafer/Year
00151956
McCarty/1978
00049637 '
Dow
Chemical/1973
00151956
McCarty/1978
00049637
Dow
Chemical/1973
00151956
McCarty/1978
00151958
Mayes/1983
00151958
Mayes/1983
Fulfills
' Guideline^
Requireraents
yes (core)
yes, (core for
formulated
product)
yes (core)
yes, (core for
formulated
product)
yes (core)
yes (core)
yes (core)
!ซ: The results indicate that triclopyr TEA is practically non-toxic to freshwater fish on an
act|e basis, the gui'del'ine requirement (72-1) is fulfilled (MRID # 00151956 and 00151958)
'' '"' ::'":i' ' ' ' ' - ' -':'- ' '' .' '-' . . , /
;';40
-------
Table 17: Freshwater Fish Acute Toxicity Triclopyr BEE
/*,,',,,,' Spates s ,,-
.> f _, - *
Rainbow trout
(Oncorhynchus mykiss)
Raiabow trout
(Oncorhynchus mykiss)
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Cbho salmon
(Oncorhyncus kissutch)
Fathead minnow
(Pimephales promelas)
Fathead minnow
(Pimephales promelas)
$*AJL~
96.98
formulated
62.9
formulated
96.98
62.9
99
96.4
96
L0ft(i?pm)
0.65 '
1.29
0.77-2.7
(24hrs)
1.46'
0.36
1.3
(2'4-hrs)
Yolk-sac
-fly:'
0.45-0.47
Juvenille '
. fiy:
' 1.4 .
2.4
(24hrs)
'2.31
(24hrs)
TOXlDJtf '
" Category ' '
highly toxic -
moderately
toxic
highly to '
moderately
' toxic
moderately
toxic
highly toxic
'moderately
Yok-sac fry:
, highly toxic ;
Juvenille fry:
moderately
' toxic
moderately
toxic .
moderately
toxic
MRIDHo- ^ -
Author/Year/' f'f
42884501
Woodbum/1 992
00134181
41971603 .
Gorzinski/1991
00134181 '
42917901
Woodbum/1 993 ,
41971604
Gozinski/1991
, 41736304
Barron/1987
00151963
Batchelder/1980
00151965
Batchelder/1981
FMlgik
; OaideKiie
Requiretnent? "
yes (core)
yes (core)
no,
supplemental
yes (core) ,
yes (core")
no, '
supplemental
no.
supplemental
no., '
supplemental
no,
supplemental
The results indicate that triclopyr BEE is moderately to highly toxic to freshwater fish on
an acute basis. The guideline requirement (72-1) is fulfilled (MRJD # 42884501, 00134181,
42917901, 41736304, 41971603, 41971604, 00151963, 00151965).
Available data on the degradate TCP from the literature and data supplied by the registrant
in the context of the reregistration of chlopyrifos sugggest slight to moderate acute toxicity to
freshwater warm- and cold-water fish species.' These data are summarized below.
41
-------
Table 18; TCP (3,5,6-TC-2-P) Acute Toxicity to Freshwater Fish
1 1 ซ 1 ft H, 1
,; 's Species
Bluegill sunfish
Rainbow trout
Rainbow trout
Coho salmon
Chum salmon
Sockeye .salmon
Chinook salmon
Pink salmon
%&
99.9%
99.9%
99.7%
99.7%
99.7%
99.7%
99.7%
99.7%
- ,LCSfi104
LOEC <162
MA.TG'
(ppm) :
130
lindjsaiats
^Affected,
length
MRIPNo.
Autbor/T'ear
00151958'
Mayes/1983
, Ffidfills
Ouidefe
, Reqairem^jits
yes (core)
iiii ! The results indicate that tricjopyr TEA may affect fish lengths at levels greater than 104
ppni. The guideline requirement (72-4) is partially fulfilled for triclopyr TEA (MRID #
00151958).
;;;';; The triclopyr degradate, TCP, is considered to be persistent in aquatic environments and
aquatic concentrations of TCP may exceed 0.01 of the LC50 for fish. Therefore, an additional
freshwater fish early lifestage toxicity study with TCP using rainbow trout (the most sensitive
species) or chum or coho salmon is required.
42
-------
(3) Freshwater Invertebrates, Acute
A freshwater aquatic invertebrate toxicity test using the technical grade of the active
ingredient is required to assess the toxicity of a pesticide to invertebrates. The preferred test
species is Daphnia magna'.Results of this test are tabulated below. ' :,
Table 20: Aquatic Invertebrate Toxicity - Tricloppyr Acid
' ' '^ Speciei- "'
Waterflea
(Daphnia Magna) -
, %'KL
99.5
LC^orBd^ ,
(ppm)
ซ
132.9
i ToxicJiy -
Category
Practically
non-toxic
IjfiUDtoa.
Akfeor/Year
40346504
McCarty/1977
Mffls
ฉsideline
Reqakemerds
yes (core)
Table 21: Aquatic Invertebrate Toxicity - Triclopyr TEA
Spates
Waterflea
Daphnia Magna
%A1 ,
44,9
LC^arBC^ !
fepm) ;
1,496
Toxicdty Category
Practically non-
toxip
MRlDNo,
Autlioj^year
00151959
Gersich/1982
Ftilffilfe
; Guideline
Reqairetti-ents
yes (core)
The results indicate that triclopyr TEA is practically noil-toxic to aquatic invertebrates on
an acute basis. The guideline requirement (72-2) is fulfilled (MRID # 00151959).
Table 22: Freshwater Invertebrate Toxicity Triclopyr BEE
.. " Species '
., s ,
Waterflea
(Daphnia magna) .
Waterflea
(Daphnia magna) ,
%AX
96,4
96.4
LฃV ^
ECsfffero)
1.7 '
(nominal cone.) ,
' 12.0 , , ,
i Tbxidtjr Catsgaty
moderately toxic
slightly toxic
' ' MRID No. i
' A-BCfeoE/Tear j
00151963
Batchelder/1980
00151965
-.Milazzo/1981 .',
Fulfils
OukMias ,
Reqwireanenfe" -
no,
supplemental
yes (core)
The results indicate that triclopyr BEE is slightly to moderately, toxic to aquatic
invertebrates on an acute basis. The guideline requirement (72-2) is fulfilled (MRID #151963
'43
-------
and 00151965). Available data suggest that the triclopyr degradate, TCP, is slightly toxic to
freshwater invertebrates on an acute basis.
(4) Freshwater Invertebrates, Chronic
An aquatic invertebrate life-cycle test is required for triclopyr because the pesticide is
intended for use such that its presence in water is likely to be continuous or recurrent. Results of
this test are tabulated below.
1 ' ' " - '
23; Freshwater Aquatic Invertebrate Life Cycle Toxicity-Triclopyr TEA
II 1 1 1 IN n n i (
Ill 1 I* II 1 (1 III I
"" " Species
i iip nin ii *
11 ^
i " < ( ,
Daphnid
(Daphnla
Ofagna)
%AX
44.9
NQECdU
OEC
$pm}
NOEC
80.7
LOEC
149.0
oMAfC
(pp?R>
110
Endpoints
Affected
total young and
mean brood
size
MRTDlfc,
.AoShor/Year
-
00151959
Gersish/1982
Fulfills
Guideline
Raqaifenteiitg
yes (core)
The results indicate thai; aquatic invertebrate reproductive impairment may occur at levels
greater than 80.7 ppm. The guideline requirement 72-4(b) is fulfilled for triclopyr TEA (MRID #
06151959).
This guideline study requirement 72-4 (b) is not needed for triclopyr BEE because a valid
fish early life-stage study 72-4(a) fulfills this data requirement.
(5) Estuarine and Marine Animals
Estuarine/marine acute toxicity testing is required for triclopyr because of forestry, rights-
of-way, rice, and turf uses. The preferred test species are sheepshead minnow, mysid shrimp and
eastern oyster. Results of these tests are tabulated below.
44
-------
Table 24: Estuarine/Marine Acute Toxicity- Triclopyr TEA
Specie
Eastern oyster (shell .
deposition)
(Crassostrea virginica)
Eastern oyster (embryo-
larvae)
.(Crassostrea virginica)
Fiddler crab
(Uca pugilator) .
Grass' shrimp
(Palaemontes pugio)
Pink shrimp
(Penaeus duorarum)
Tidewater silverside
(Menidia beryllina)
%AJL '.
46.09
43.8. v.
43.8
46.09
43.8
44.7
: LCsa/BC^Q
<$&*$
58 '
>56
<87ppm
(48hrEC50)
>1000
326
895 ';'
'130
Toxicilgi'
Category
slightly ,
100% abnormal
development at
87ppm
practically non-
toxic
(
practically non-
toxic . "
practically non-
toxic
practically non--
toxic
MRS} No,
AutliGi/Year
42646101 '
Kowalski/1992 ,
0062623
EG&G/1975 -
0062623 ,
EG&G/1975- .
,42646102 . '., .
Kowalski/1992
0062623
EG&G/1975 .
41633703
Ward/1989
Fulfills S-aideHne
Requiremeuli -
yes (core), for
formulated
product
yes (core), for
formulated
product
no, supplemental
yes (core), for
formulated
product
no, supplemental
yes (core), for
formulated -
product
The results indicate that triclopyr TEA is slightly toxic to practically non-toxic to
estuarine/marine invertebrates on an acute basis and practically non-toxic to estuarine/marine fish
on an acute basis. The guideline requirement (72-3 (d) & (e)) is fulfilled (MEUD # 42646101,
42646102,41633703,0062623).
45
-------
Table 25: Estaurine/Marine Toxicity-Triclopyr BEE
" a. JT-^ ซ * ^ Jfjffi. !.
Species
Eastern oyster
(shell deposition)
(Crassostrea virginica)
Eastern oyster (shell
deposition)
(Crassostrea virginica)
Estuarine (Grass) slirimp
(Palaemonetes pugio)
Estuarine (Grass) shrimp
(Palaemonetes pttgio)
Tidewater silverside
(Menidia beryllina)
Tidewater
silversidefft/e/wW/a
beryllina)
%A,L
96.1
62.9
(Garlon4)
96.1
62.4
(Garlon 4)
96.1
62.9
(Garlon 4)
LQa^S,
* {pptrt}
Species
0.32
2.47
1.7
0.45
0.76
Toiicitv
Category
highly toxic
highly toxic
moderately
toxic
moderately
toxic
highly toxic
highly toxic
MRID No. . ,
Aa&or/Year
41971602
Boeri/1991
41969903
Boeri/1991
41971601
Boeri/1991
41969902
Ward/1991
42053901
Ward/1991
41969901
Ward/1991
; Fulfills Guideline
Keigaiitattfittfcs
yes (core)
yes (core for
formulated
product)
yes (core)
yes (core for
formulated
product)
yes (core)
yes (core for
formulated product)
The results indicate that triclopyr BEE is moderately to highly toxic to estuarine/marine
invertebrates on an acute basis and highly toxic to estuarine/marine fish on an acute basis. The
guideline requirement (72-3 (a), (b), (c), (d), (e), & (f)) is fulfilled (MRID #41971602,
41969903,41971601,41969902,42053901,41969901).
(6) Estuarine and Marine Animals, Chronic
Chronic estuarine/marine studies are not required for triclopyr TEA and BEE because they are not
expected to be continuous or recurrent in the estuarine/marine ecosystem.
c. Toxicity to Plants
:;"': ;''.'"; ซ ; '' X1)' '''. Terrestrial' ^ ' ' : i " " "''. ' .
Terrestrial plant testing (GLN #122-1, 123-1) is required for triclopyr TEA and BEE.
These herbicides have terrestrial non-residential outdoor use patterns and may move off the
Application site by runoff or spray drift.
For seed germination, seedling emergence and vegetative vigor testing the following plant
species and groups must be tested: (1) six species of at least four dicotyledonous families, which
46
-------
should include soybean (Glycine max} and one root crop species, and (2) four species of at least
two monocotyledonous families, one of which must be corn (Zea mays}. -, . .
Tier I tests (122-1) are designed to show if the plants are inhibited at less than 25% when
compared to the control. If the plants show 25% or greater inhibition, then Tier II level testing
(123-1) is required.
Tier I results for triclopyr TEA and BEE show that except for seed germination in-corn, ,
all species tested showed greater than 25% inhibition for seed germination (MRID 41734301),'
seedling emergence (MRID 41734301), and vegetative vigor (MRID 41784401), thereby
.triggering the need for Tier II testing for all ten species. '
Results from the Tier II (Guideline 123-1) testing for triclopyr TEA of the most sensitive
species are reported below. .'._".' ' -
Table 26: Terrestrial Non-Target Plant Toxicity-Triclbpyr TEA
' Type. 6? Test
Psfspsnt 9i ,
Seed
Germination
. 45.2% triclopyr
Seedling
Emergence
45. 2% triclopyr
Vegetative
Vigor
45.2% triclopyr
Most
seaside
species-
sugar beet.
i
corn
corn
radish
onion ;
sunflower
paratneter ,
radicle length
radicle length
% emergence
and shoot
length
% emergence
and shoot
length
shoot weight
shoot length
$
BCjj
: ft si/A- -"
0.0007 ppm1
o.oi i 6 ppm1
>0.333
>1.0
0.1660;
0.0076
NpIL,,.
Tbk/A"ฐ
O.OOOZppm'
.0.0123 ppm1
0.3330 '
0.3330
0.1110
,0.0041
MRHM
^ Author/Vfear
43129801
Schwab/1993
43129801
Schwab/1993
43129801
Schwab/1993
Fulfill
Gtti-cfelfoe'
Requirement
yes, '(core)
yes (core)
yes (core)
1 The endpoints from the seed germination study are in ppm instead of Ib ai/A because the seeds
are tested in a solution rather than sprayed. ,
In seed germination studies, triclopyr TEA was most toxic to sugar beet and corn, with
EC25s of 0.0007 and 0.0116 ppm, and NOELs of 0.0002 and 0.0123 ppm, respectively.
In seedling emergence studies, triclopyr TEA was most toxic to corn and radish, with
EC25s of >0.0333 and >1 Ib ai/A, respectively. The NOEL for both corn -and radish was > 0.333
Ibai/A. ... , . . ".'-. , '.-
In vegetative vigor studies, triclopyr TEA was most toxic to onion and sunflower, with
of 0.166 and 0.0076 Ib ai/A, and NOELs of 6.111 and 0.0041 Ib ai/A, respectively. '
47
-------
ilBff"! f!f!'! If'VS'i '''IK;Si:,' '(<';;'!"!!!', I" :'!
It,hi*; g,,i.'?i -, if, '>' .. .. 1!' . ,
Results from the Tier n (Guideline 123-1) testing for triclopyr BEE of the most sensitive
species are reported below. A seedling germination study had been conducted for triclopyr BEE,
however, it was invalid; a new test is not required (based on current guidelines).
Table 27: Terrestrial Non-Target Plant Toxicity-Triclopyr BEE
" Type of Test
Percent ai
H . f i,,.,
Seedling
Emergence
62.2% Triclopyr
Vegetative Vigor
62.2% Triclopyr
Most
sensitive
species '
onion
alfalfa
onion
sunflower
parameter
shoot weight
emergence
shoot weight
shoot weight
BC^
Ifad/A '
0.0732
0.0622
0.0888
0.0089
NOEL or
IBC^
r & Hi/A
0.0030
0.0036
O.088
0.0039
MR1D# ,
A*tfhฃav$?ear
j*" f
43650001
Schwab,
1995
43650001
Schwab,
1995
FtOfflfe
Oaid&Iine ,
R^qukejae&ts
yes, core
yes, (core)
In seedling emergence studies, triclopyr BEE was most toxic to alfalfa and onion, with
; of 0.0622 and 0.0732 Ib ai/A and NOELs of < 0.0622 and 0.0030 Ib ai/A, respectively.
In vegetative vigor studies, triclopyr BEE was most toxic to sunflower and onion, with EC25s of
0.0089 and 0.0883 Ib ai/A and NOELs of 0.0039 and O.088 Ib ai/A, respectively.
, ,'. ", . J,.1; , . , 2,, Aquatic
Aquatic plant testing is required for triclopyr because aerial application and outdoor non-
residential use will expose non-target aquatic plants to triclopyr. The following species should be
tesjed at Tier II: Kirchneria siibcapitata (Selenasirum capicornutwn), Lemna gibba,
Skeletonema costatum, Andbaenaflos-aquae, and a freshwater diatom.
Results of Tier n (Guideline 123-2) toxicity testing on the technical/TEP materials are tabulated
below.
48
-------
Table 28: Non-Target Aquatic Plant Toxicity-Triclopyr TEA
Species " - -
> ^ ' ' 'f
Skeletonema costattim
Lemna gibba
Lemna gibba
Anabaenaflos-aquae
Kirchneria subcapitata
(Selenastrum
capicornutum)
Navicula pelliculosa
Selenastrum
capricornutum
>%AL
45:01%
45.01%
45.00%
45.0% ',
45.01% -
45.'0%
98.8% ,
Iriclopyr acid
fiCS(j
. ($>3ป;,ai)
6.70
8.80
11.00
5.90 ,
7.60
15.30
32^5 '
BCซ or>?OEC
^pprnaj)
"0.40
3.5 . .
3.5;
2.0
10 " . ..
8.0
7.0
^MRIDNo, '
Aafiior/Y-eaf
* ^ jf
41633707
Cowgill,1987
'41633709
Cowgill, 1987
41736302
Cowgill, 1988
41633706
Cowgill. 1987
41633705
Cowgill, 1987
41633708
Cowgill, 1987.
41736303 ,
CowgiIl/1989
Fulfills
Omde1ni;&
KeqUBrejoaeirf
yes, core
yes, core
yes, core
. yes, cor .
ye's, core
yes, core ./ ,
no,
supplemental
These results indicate that exposure levels of 8.80 or greater ppm ai triclopyr TEA may
cause detrimental effects to the growth and reproduction of vascular aquatic plant species. Algae
or diatoms may be affected from exposure levels of greater than 5,9 ppm ai triclopyr TEA or
32.45 ppm ai of triclopyr acid. The guideline requirement (123-2) is fulfilled. (MRID# 41633705,
41633706,41633707,41633708,41633709,41736302,41736303).
49
-------
Table 29: Non-Target Aquatic Plant Toxicity-Triclopyr BEE
,h 5 (dissociation constant pKa 2.93). Tlaerefore, tnciopyr anion will be the predominant
mQiety present in the environment when products containing either triclopyr BEE or triclopyr
TEA are used. Triclopyr acid/anion is somewhat persistent, but is mobile. The predominant
degradation pathway for triclopyr in water is photodegradation. The predominant degradation
pathway in soil is microbial degradation to the major degradate 3,5,6-trichioro-2-pyridinol (TCP),
which is both persistent and mobile.
,, ; Triclopyr acid is non-volatile (vapor pressure 1.26xlO"6 mm Hg) and highly soluble (water
solubility of 430 mg/L [WSSA, 1989]). Triclopyr TEA is a non-volatile, very soluble salt (vapor
50
li.;.i1!' iillilL 'If*'
-------
pressure < 1 x 10'8; solubility 4.12x10s mg/L at pH 7). Triclopyr BEE is non-volatile (vapor.
pressure 3.6 x 10"6 mm Hg) and shows relatively low solubility (6.8 ppm).
Triclopyr TEA will not persist as the salt under normal environmental conditions. In
measurements of conductance of a solution of triclopyrTEA in water as a function of time,
triclopyr TEA dissolved and dissociated completely to the acid within one minute.
Triclopyr BEE will persist in the environment as the ester for only a limited duration:
Triclopyr BEE hydrolyzed quickly to triclopyr acid in natural waters (pH 6.7; half-life of 0.5
days). Supplemental information indicates that triclopyr BEE degrades to triclopyr acid with a
half-life of about three hours when applied to silty clay loam, silt loam, and sandy loam soils. In
all three soils, less than 3.2% of the applied triclopyr BEE remained after 48 hours. This behavior
was also observed in the field. The half-life of triclopyr BEE in a terrestrial field dissipation study
was 1.1 days, while total triclopyr (BEE plus triclopyr) half-life was-10.6 days.
Triclopyr acid is a weak acid which will dissociate completely to the triciopyr anion at pHs
> 5 (dissociation constant pKa 2.93). Therefore, triclopyr anion will be the moiety present in the
environment when products containing either triclopyr BEE and triciopyr TEA are used.
Based on laboratory studies, triclopyr acid is stable to hydrolysis and anaerobic aquatic
metabolism; it degrades slowly under aerobic aquatic conditions. Triclopyr acid does not
bioaccumulate in aquatic organisms. , , ',;-''
It appears that aqueous photolysis is a predominant degradation mechanism in aquatic
media. Photodegradation of triclopyr acid was rapid; the half-life was less than 1 da}' in sterile
solutions and approximately 1 day in natural water. The major photodegradation product
observed in sterile solutions was 5-chloro-3,6-dihydroxy-2-pyridiiioloxyacetic acid (TCP); oxamic
acid was the major degradation product in natural river water.
The aquatic dissipation half-lives observed in the field are consistent with the shorter half-.
lives observed in the photolysis in water studies. In general,, results of the available studies
suggest that triclopyr acid is rapidly dissipated under aquatic conditions in the field (tK = 0.5-3.5
days hi Lake Seminole, Georgia in an Aquatic.Field Dissipation study; and 5 days in pond water in
a Forestry Field Dissipation study). Some factors that could affect the rate of dissipation in .cases
where aqueous photolysis is an important dissipation factor include vegetative-cover, type of
vegetation, depth of the plot, and suspended sediment, . . .
In soil, the predominant degradation mechanism for triclopyr acid is biotic metabolism.
Triclopyr acid degraded in aerobic soil.with half-lives of 8 to 18 days to intermediate degradates
3,5,6-trichloro-2-pyridinol (TCP) -and 3,5,6-trichloro-2-methoxypyridine (TMP); the ultimate
degradate is carbon dioxide. TCP was also observed as a minor degradate in the aerobic aquatic
metabolism study. , . -'. '
51
-------
:" * ;" |; j,^1'; Total tf ciopyr residues did not persist in field dissipation studies. When triclopyr BEE
it '" yf|| applied to bare soil in North Carolina, triclopyr BEE degraded to triclopyr acid with a half-
life of 1.1 days; total triclopyr residues dissipated with a half-life of 10.4 days. Half-lives of total
" triclopyr in bare-ground and vegetated plots in California were approximately two weeks and 33
days, respectively.
Based on adsorptipn/desprptipn studies, triclopyr acid and its major degradate TCP are
expected to be very mobile in soils. Freundlich Kads for triclopyr were 0.165-0.975 mL/g; values
for TCP were 0.53-1.95 mL/g. In the field dissipation studies, low concentrations of triclopyr
were found in soil depths of up to 45 cm, however, triclopyr did not persist.
The degradation products TCP and TMP were recovered in the terrestrial field dissipation
studies, with TCP found at higher concentrations than IMP in both the bare and vegetated soil
plots. TCP was detected up to 36 weeks after treatment in vegetated soil; it represented a
considerable amount (0.131 ppm) at 63 weeks (last test interval) in bare soil. In the forestry
studies, TCP was generally limited to the upper 30 cm of the soil, with sporadic detections in
deeper soil depths. Based on these observations it appears that TCP is persistent and mobile in
thefield, , . ,. ,, '.,,. , ,,, , , ',
The primary degradation pathway for triclopyr TEA is dissociation to the triclopyr acid
and triethanolamine. Triethanolamine is then degraded by aerobic microbial processes to CO2
(soil half-life 5.6 -13.7 days). In aquatic conditions it is stable (half life 14-18 days) and then
proceeds to rapid degradation. However, triethanolamine is stable to degradation under
anaerobic aquatic conditions (half-life > 2 years). Because of the rapid microbial degradation
urltjeif aerobic conditions, it is not expected that volatilization, photodegradation, or
bipaccumulatipn in fish will contribute significantly to the dissipation of triethanolamine.
' Trie primary degradation pathway for triclopyr BEE is hydrolysis to triclopyr acid and 2-
butoxyethanol, with hydrolysis occurring more rapidly at higher pHs. 2-Butoxyethanol is then
rapidly degraded by microbial processes (aerobic soil and aquatic) to 2-butoxy acetic acid (half-
lives of 0.375 - 0.058 days in soil; half-life of 0.6-3.4 days in a sediment/water mixture), with the
final degradate as CO2. 2-Butoxyethanol and 2-butoxyacetic acid are somewhat more persistent
ur|$er anaerobic aquatic conditions (half-lives of 1.4 and 73.3 days respectively in an anaerobic
sediment/water nurture) with the final degradate as COjj 2-Butoxyethanol (also known as
ethylene glycol monobutyl ether) has a perceptible vapor pressure (0.76 mm at 20 C; Condensed
Chemical Dictionary, 10th edition); however, because of the rapid microbial degradation, it is not
expected that volatilization will contribute significantly to the dissipation of 2-butoxyethanoI.
Because of the rapid microbial degradation, it is not expected that photodegradation or
bioaccumulation in fish will contribute significantly to the dissipation of butoxyethanol.
Triclopyr is moderately persistent, with persistence increasing as it reaches deeper soil
levels and anaerobic conditions; it is also very mobile. Because triclopyr is not expected to reach
high concentrations in ground water and it is not toxic, EF.ED concludes that it is not a.concern
: , , ;..-. , . , ' ' :.. 52 , . ' " '..
-------
for drinking water that is derived from ground water sources. However, both triclopyr BEE and
triclopyr TEA may produce TCP which is relatively mobile and persistent and has the potential to
degrade groundwater. Therefore, the Agency continues to recommend a ground water label
advisory and to keep the ground water study in reserve. Triclopyr and TCP do not adsorb to soil
" and sediment particles, and may be transported in surface runoff waters. Although, triclopyr is
not predicted to. persist in surface waters, information from two aquatic field dissipation studies
conducted on rice indicates that following application of triclopyr, TCP can persist in flood
waters. Triclopyr is not currently regulated under the Safe Drinking Water Act (SDWA);
therefore, a Maximum Contaminant Level (MCL) is not established. Public water supply systems
. are not required to sample and analyze for triclopyr.
b. Environmental Fate and Transport
(1) Degradation
Abiotic Hydrolysis
Triclopyr acid is stable to hydrolysis at pH 5, 7, and 9 in sterile buffered solutions. The
guideline requirement for triclopyr acid is fulfilled (GLN 161-1; MRID 4187960!),
The hydrolysis of triclopyr BEE is pH dependent, with rate of hydrolysis increasing with
increasing pH. Triclopyr BEE hydrolyzed in sterile buffered solutions at ptTs of 5, 7 and 9 with
Calculated half-lives of 84.0, 8.7 and 0.3 days, respectively. It hydrolyzed in natural water (Black
Creek, Chippewa, Michigan; pH 6.7) with a calculated half-life of 0.5 days. The major identified
degiradate in all cases was triclopyr acid, which is stable to hydrolysis (see above). The guideline
requirement for triclopyr BEE is fulfilled (GLN 161-1; MRID 00134174).
Photodegradation
- .*..;, \
Photodegradation in water: '
Triclopyr acid photodegraded in sterile aqueous buffered solutions (pH 7) with half-lives
of 0.6 days (8-9 hours) using natural light (August in Michigan) and 0.36 days using filtered Hg
lamps (samples irradiated continuously). The half-lives in river water using natural and artificial
light sources were 1.7 and 0.7 days, respectively. Triclopyr acid did not degrade in similar
solutions'incubated in the dark for up to 3 days. Identified degradates in both sterile solutions and
river water were 5-chloro-3,6-dihydroxy-2-pyridinyloxyacetic acid and oxamic acid; 5-chloro-3,6-
dihydroxy-2-pyridinyloxyaeetic acid was the major degradate in the sterile solutions (up to 48%
of the applied), while oxamic acid predominated in the river water (up to 16% of the applied).
The guideline requirement for triclopyr acid is fulfilled (GLN 161-2; MRIDs 4173 2201 and
42411804), , '. ". :
53
-------
[14C]TricIopyr BEE (pyridine ring labeled in the 2 and 6 position), at 1.0 ppm,
photodegraded with a registrant-calculated half-life of 6.6 days in sterile pH 5 aqueous buffer
solutions that were irradiated outdoors in California for 30 days, Triclopyr BEE was stable
( \. :,' : ' " ". . ' ' : / '. ' .', ' ,,!.'
PhotodegraSation in air:
'," *, ;.!|'| ;:' ' ' ;'iV '; ^ , ,'|:.\ip /', i ; ;;:. . '','. '. i,'Ul ! ''',,''
1 , if;!!!:! ;'.j ''. 'I1', ,' -' . .,. ', ,. a, :,",' :'.' ' ' , ',-, ,, :i ;.. .:'. ''",;, ""ป':,;:, . " .
1 No data were reviewed for photodegradation in air (GLN 161-4). The requirement for
this environmental fate study was waived due to the low vapor pressures of technical triclopyr,
triclopyr BEE, and triclopyr TEA. These are 1.26 x 10"6 Torr [WSSA, 1989], 3.6 x 10"6 Torr
pMRIDs 40557003 and 42443402], and < 1 x' 10'8 mm Hg 0VDRID 41219104], respectively. The
low vapor pressures and the small Henry's Law constants (which are indicators of the low
tendency for the material to volatilize from water; estimated to be 9.65 x 10"10, 2.47 x 10"!, and
1.J5 x 10"14 atm-m^mol"1 for trjclppyr, triclopyr BEE, and triclopyr TEA, respectively) indicate
that volatilization and subsequent photodegradation in air would not be a significant route of
dissipation for triclopyr TEA and BEE.
Aerobic Soil Metabolism
Under aerobic soil metabolism conditions, triclopyr acid, at 1 ppm, degraded with half-
lives of 8 and 18 days in silty clay loam and silt loam soils, respectively. The non-volatile
degradates observed during the study were 3,5,6-trichloro-2-pyridinol (TCP) and 3,5,6-trichloro-
2-methoxypyridine (TMP); they were not persistent (maximum concentrations of 26 and 8%,
respectively, were seen after <30 days of incubation. The ultimate degradate was carbon dioxide
(at 300 days posttreatment, approximately 70 and 80% of the applied radioactivity in the silt loam
arid silty clay soils, respectively). The guideline requirement for the triclopyr acid is fulfilled
(GLN 162-1, MRID 40346304).
54
-------
[14C-l-emyl]triethylaminehydrochloride,at5.03 iig/g degraded with first order half-
lives of 5.6 and 13.7 days from a sandy loam and a silt loam soil, respectively, incubated under
aerobic conditions at 25 C for 182 days. The major degradation product was 14CO2, which was
>60% of the applied by 24 days after treatment in the sandy loam and 91 days after treatment in
the silt loam. A second degradate was observed at a maximum of 8% at 7 days after treatment in
the sandy loam and 37% at 24 days after treatment in the silt loam.' This metabolite decreased
rapidly to low (<2.5%) levels in both soils. Efforts to obtain a definitive identification for this
metabolite were unsuccessful. The guideline requirement for the TEA moiety is fulfilled.(GLN
162-1, MRID 43837501). .
Radiolabeled [14C-l-butyl] 2-butoxyethanoI, at 6 ug/g, degraded with calculated first-
order half-lives of 0.9 hours (0.375 days) from Hanford sandy loam and 1.4 hours (0.058 days)
from Commerce silt loam incubated under aerobic conditions at 25 C for 4 and 10 days,
respectively. The intermediate metabolite was 2-butoxyacetic acid, which comprised 85.1-
101.0% of the applied at 4-24 hours posttreatment It was rapidly metabolized to the major
degradation product, 14CO2, which reached a maximum of approximately 50% of the applied by
96 hours (4'days) after treatment in the Hanford sandy loam and approximately 50% of the
applied by 10 days after treatment in the Commerce silt loam. Unextracted [14C]residues were a
maximum of 19% in both soils at 4 and 10 days, respectively. The guideline requirement for the
BEE moiety is "fulfilled (GLN 162-1, MRID 43799101).
Anaerobic Soil Metabolism ,
. This data requirement is fulfilled by the 162-3 study (see below). , .
Anaerobic Aquatic Metabolism
Triclopyr BEE degraded quantitatively to triclopyr acid in less than one day
(approximately 5 hours) in two sandy loam soils incubated anaerobically (flooding plus nitrogen)
for 30 days prior to pesticide addition. Triclopyr acid was then persistent under anaerobic
conditions, decreasing to approximately 80% of the applied after 365 days'. The registrant
calculated a half-life of 1300 days; however, confidence in this value is limited because of the
extrapolation outside the duration of the study. The only identified degradate was TCP at
maximum concentrations of approximately 25% of the applied at 365 days posttreatment; the
majority of the radioactivity was associated with the floodwater. The guideline requirements for
both triclopyr acid and BEE triclopyr are fulfilled by this study (GLN 162-3; MRID
00151967). , .:_.:..
[14C-l-ethyl]Triethylamine hydrochloride (TEA-HC1), applied at a nominal
concentration of 1.36 fig/mL in water, degraded with a calculated half-life of 2 years in an
anaerobic (flooding plus nitrogen atmosphere; E^ values of-139 to -296 mV) sediment-water
system. TEA was equally distributed between the water and sediment extracts; 10-19% of the '
applied [14C] remained bound to the sediment after extraction with organic solvents. Volatiles
" ' " i . *
.'''' -^ ' ' ' 55 .' ' , '
-------
were less than 1% of the applied radioactivity through 6 months (the duration of the study). The
guideline requirement for the TEA moiety is fulfilled (GLN 162-3; MRID 43837502).
Radiolabeled [14C-1 -butyl] 2-butoxyethanoI degraded with a calculated first order half-
life of 1.4 days hi a sedimenl/water mixture (554.1 ug 2-butoxyethanol in 50 g sediment/129.9 mL
pond water) incubated under anaerobic conditions (flooded plus nitrogen atmosphere; dissolved
oxygen content 0.3 mg/L, Ey, -200 mV) at 25 C for 193 days. The intermediate metabolite,
2-butoxyacetic acid, comprised a maximum of 71.8% of the applied at 7 days posttreatment, and
declined with an observed half-life of 73.3 days. The ultimate degradation product was 14CO2,
which was 57.4% of the applied at the termination of the study (193 days after treatment).
Unextracted [l4C]residues were a maximum of 9.9% at 29 days posttreatment. The guideline "
requirement for the BEE moiety is fulfilled (GLN 162-3, MRID 43799103).
Aerobic Aquatic Metabolism
, , >,.
Triclopyr acid degraded slowly (t,/: = 142 days) in a silty clay soil:water system incubated
aefobically for 30 days. The only degradate observed was 3,5,6-trichloro-2-pyridinol (TCP) at
<5*fa of lie amount applied at 30 days; however, the study was not conducted for a sufficient
duration to adequately describe the formation and decline of the degradate TCP. Additional
information on the aerobic aquatic metabolism of TCP is required. The guideline requirement for
triclopyr acid is partially fulfilled (GLN 162-4; MRID 40479101).
[14C-l-Ethyl]triethylamine hydrochloride (TEA-HC1; nominal concentration of 1.33
ug/mL in water) did not appreciably degrade during the first 14 days after application to an
aerobic sediment-water system. By 18 days posttreatment (the next sampling interval), TEA-HC1
had decreased to approximately 5% of the initial application, In addition, up until 14 days
posttreatment, <2% of the radioactivity had been evolved as 14CO2, and < 5% was unextractable
residues. By 18 days posttreatment (the next sampling interval), >60% of the radioactivity had
evolved as 14CO2, and approximately 25% was bound to sediment. Dissolved O2 levels decreased
substantially at the beginning of the study from 6.5-6.7 ppm at 0 days after treatment to <2 ppm
at 1-7 days after treatment. The guideline requirement for the TEA moiety is partially fulfilled
(GLN.162-4, MRID 43837503).
Radiolabeled [14C-1-butyl] 2-butoxyethanol, at an application rate of 427 ug 2-
butpxyethanol added to 10 g sediment plus 106 mL water, degraded with a first order half-life of
0.6-3.4 days in a moist sediment/water mixture incubated under aerobic conditions at 25 C for
10 days. The intermediate metabolite, 2-butoxyacetic acid, comprised a maximum of 53.9% of
the applied at 3 days posttreatment, and declined with an observed half-life of approximately 1
day. The ultimate degradation product was 14CO2, which was 69.0% of the applied at 10 days
after treatment Unextracted [I4C]residues were a maximum of 9.9% at 10 days posttreatment.
The guideline requirement for the BEE moiety is partially fulfilled (GLN 162-4, MRID
43799106).
56
-------
c. Mobility
Mobility studies are not required for the TEA or BEE; moieties because of their rapid
degradation in soils.; ."..'
Adsorption/desorption studies i
:Based on adsorption/desorption studies usirig sand, sandy loam, silt loam, and clay loam
soils, imaged triclopyr acid was very mobile. Freundlich Kads values ranged from 0.165 to 0.975
mL/g; Kocs were 25-384'mL/g. Adsorption was not correlated with CEC or organic carbon
content. The guideline requirement for unaged triclopyr acid is fulfilled (GLN 163-1; MRID
40749801).
Supplemental information from this same study indicate that triclopyr acid residues were
also very mobile after 15 and 30 days aging periods. Estimated Koc values for the degradate
3,5,6-trichloro-2-pyridinol (TCP) ranged from 14 to 86 mL/g (MRID 40749801)...
3,5,6-Trichloro-2-pyridinol (TCP), a major-degradate of triclopyr, was very mobile in
sand, sandy loam, silt loam, 'arid clay loam soils with Freundlich K3ds.values of 0.53-1.95 mL/g.
The guideline requirement for aged triclopyr acid is fulfilled (GLN 163-1; MRID 42493901).
Volatility studies
No laboratory volatility (GLN 163-2) or field volatility (GLN. 163-3) studies were
reviewed for triclopyr derivatives (there are no end use products containing triclopyr acid). The
requirement for this environmental fate study was waived due to the low vapor pressures of
technical triclopyr, triclopyr BEE, and triclopyr TEA (1.26 x 10"6 Torr [WSSA, 1989], 3.6 x 10"6'
Torr [MRIDs 40557003 and 42443402], and < 1 x 10'8 mm Hg [MRID 41219104], respectively).
The low vapor pressures and the small Henry's Law constants (which are indicators of the low
tendency for the material to volatilize from water; estimated to be 9.65 x 10"10, 2.47 x 10'7, and -
1:15 x 10'14 atm-m3 mol'1 for triclopyr, triclopyr BEE, and triclopyr TEA, respectively) indicate
that volatilization would not be a significant route of dissipation for triclopyr derivatives.
(1) Accumulation
No fully acceptable laboratory bioaccumulation in fish (GLN 165-4) or accumulation in
aquatic non-target organisms (GLN 165-5) studies have been reviewed for triclopyr derivatives.
However,, the requirement for these environmental fate studies were waived for triclopyr
TEA due to its low octanol/water partition coefficient (Kovv< 5, MRID 41219101). In addition,
since triclopyr BEE degrades rapidly to the acid in natural waters (half-life 0.5 days; MRID
00134174), it can also be assumed to not bioa'ccumulate. Information contained in supplemental
studies (Acc.nos. 073872 and 229782) showed that only slight bioaccumulation (<10x) was
. .' ' - - 57 , :;.'. .
-------
observed for triclopyr acid and its degradate TCP. The data requirement has therefore also been
waived for triclopyr BEE.
(2) Field Dissipation
' Field dissipation studies are not required for triclopyr acid since there are currently no
registered end use products containing triclopyr acid.
Terrestrial - Triclopyr BEE
Triclopyr BEE was applied at 8.1 Ib ae/A (Garlon 4, 44.3% EC) to a bareground plot of
sandy loam soil in.North Carolina. Triclopyr BEE degraded to triclopyr acid with a registrant-
* calculated half-life of 1.1 days from the 0- to 7.5-cm soil 'depth. Triclopyr BEE was detected only
in the 0- to 7:5-cm depth and only until 7 days posttreatmerit. Total triclopyr (triclopyr BEE plus
' '' triclopyr acid) dissipated from the 0- to 7.5-cm soil depth with a registrant-calculated half-life of
: "': .: 10.6 days. Total triclopyr was detected at up to 0.14 ppm in the 15- to 30-cm depth at 4 weeks
posttreatmeni; at all later sampling intervals, concentrations were 0.02 ppm. Total triclopyr
was detected in the 30- to 45-cm depth at 7 days posttreatment at 0.04 ppm, declined to 0.03
ppm at 2 weeks posttreatment, and was not detected thereafter. Total triclopyr was not detected
at depths greater than 45 cm.
Two degradates were monitored and recovered from the soil samples. 3,5,6-Trichloro-2-
pyridinol (TCP, pyridinol) was 0.04-1.40 ppm immediately posttreatment and 0.11-0.49 ppm at 7
f days in the 0-to 7.5-cm soil depth. TCP was first detected in the 7.5-to 15-cm depth at 3 days
"" po^rlrealment at up to 0.11 ppm and was: present at up to 6.13 ppm at 7 days. At two weeks ,
;: ~ posttreatment, the 0- to 15-cm segments contained up to 0.18 ppm TCP, increased to 0.33 ppm at
4 weeks, and then Decreased to 0.06-(X09 ppm at 8 weeks. TCP then decreased slowly in the 0-
15^ cm soil depth to 0.02-0.03 at 52 weeks posttreatment. TCP was not detected below the 30-
crfi soil depth. 3,5,6-Trichloro-2-methoxypyridine CTMP, methoxypyridine) was 0.15-0.35 ppm
immediately posttreatment and 0.05-0.17 ppm at 7 days in the 6- to 7.5-cm soil depth. TCP was
first detected In the 7.5-to 15-cm depth at 3 days posttreatment at up to 0.05 ppm and was
present at up to 0.04 ppm at 7 days. At two weeks posttreatment, the 0- to 15-cm segments
contained up to 0.08 ppm IMP, increased to 0.09 ppm at 4 weeks, and then decreased to 0.03-
O.Q5 ppm at 8 weeks. TCP then decreased slowly in the 0-15 cm soil depth to 0.02 at 52 weeks
posttreatment. TMP was not detected below the 30-cm soil depth. (GLN 164-1, (MRID
43033401)." ' ! ' "" '. ':' ' '' " '
11 i งc ; Total tnclopyr (triclopyr BEE plus triclopyr acid) dissipated with an observed half-life of
approximately 2 weeks in the 0- to 6-inch depth of a bare ground loam soil plot located in
California that was treated with triclopyr butoxyethyl ester (TBEE; Garlon 4, 44.3% ae EC) at
6.4 Ib ae/A. In the upper 6 inches of a "native short grass"-covered plot at the same site, total
triclopyr dissipated with an observed half-life of 4-8 weeks and a "best fit" registrant-calculated
half-life of 33 days. Two degradates were recovered from the soil: 3,5,6-trichloro-2-pyridinol
, T||II , , r o
JO
-------
(TCP; pyridinbl) and 3,5,6-trichloro-2-methoxypyridme (TMP; methoxypyridine). In the upper 6
inches TCP was a maximum of 0.067 ppm at 28 weeks in the unvegetated soil plot; TMP was a
0.05 ppm at all test intervals. In general,, neither triclopyr nor its degradates were detected
below the 6-inch soil depth. TCP and TMP residues generally averaged 0.01 ppm in soil
segments collected from both the unvegetated and grassed plots below the 6-inch soil depth at all
sampling intervals, with only one exception. (MRIDs 42730601 and 44039301). The guideline
requirement for the use of triclopyr BEE on terrestrial field sites is fulfilled with these studies
(GLN 164-1, MRID 43033401, and MRIDs 42730601 and 44039301). '.:"'.
Aquatic - Triclopyr TEA
' - ' '"';.,
Triclopyr (applied as the TEA salt at 27-30 Jb ae/A) dissipated with half-lives of < 1 day in
the surface and bottom water of plots (660 x 500 feet) located in Banks Lake, Washington,
following surface (boat) and aerial (helicopter) application. The degradate 3,5,6~trichloro-2-
pyridinol (TCP,) was not detected (<0.05 ppm) in surface (1-foot depth) or bottom (3 feet above
the'bottom) waters at any sampling interval. Triclopyr and TCP were not detected in the
sediment (<0.10 ppm and <0.05 ppm. respectively) at any interval., Samples were not analyzed
for the degradate 3,5,6-trichloro-2-methoxypyridine (TMP; methoxypyridine). This study was
declared scientifically sound, but it could not be used to fulfill data requirements because
sustained high winds (10-15 mph, gusting to 20 mph) occurred immediately posttreatment. This
was not representative of conditions that normally occur, and the atypical weather conditions
possibly accelerated the dissipation and degradation of the test substance (MRID 41714305).
Triciopyr acid (applied as the TEA salt at 27-30 Ib ae/A) dissipated with calculated half-
lives of 0.5'and 3.5 days in the surface, waters of 10-acre plots located in the Spring Creek arm of
Lake Seminole, Georgia, following surface and aerial applications, respectively. The-plots were
approximately 65-75% covered with vegetation at time of application. The degradate 3,5,6-
trichloro-2-pyridinol (TCP) was detected at 0.06-0.18 ppm in surface (1-foot depth) and bottom
(3 feet above the bottom) waters 1- to 8 hours after, application, but was not detected (<0.05 ,ppm)
in surface or bottom water after 1 day posttreatment. Triclopyr was detected at up to 0.64 ppm
in the sediment layer (up to 5-10 cm deep)' immediately posttreatment, but was <0.10 ppm
(detection limit) at all other sampling intervals; TCP was not detected in the sediment (<0.05
ppm) at any interval. Samples were not analyzed for the degradate 3,5,6-trichiorb-2-
methoxypyridine (TMP; methoxypyridine). Different rates of dissipation may have been due to ,
water movement through the plots (the plot receiving the surface application was open on all
sides and was < 0.5 miles from the main channel, while the plot receiving the aerial application
was bounded on two sides by land and was 0.5-1.5 miles from the main channel.. The guideline
requirement for use of triclopyr TEA on aquatic weeds is partially fulfilled (GLN 164-2; MRIDs
41714304 and 42821301). . '; ~
Triclopyr dissipated with observed half-lives of less than 12 days in the soil and less than 8!
days in the flood waters of rice plots that were treated twice at 0.375 Ib ae/A each time with the
triethylaniine salt of triclopyr (3,5,6-trichloro-2-pyridiyIoxyacetic acid). In May-June, 1994, rice
' - . \
>' . 59 ' . '
-------
plots in Louisiana and Arkansas were treated at the 3-tp-4 leaf stage (not flooded at time of
ap|lication) and.at1/2-inch internode elongation (28 days after the first application; flooded). In
the flood waters (plots flooded 5 days after first application), triclopyr dissipated with a "best fit"
calculated half-life of 7.6 days at the AR site and 2.2 days at the LA site. At both sites, maximum
residues of triclopyr in the flood water were found immediately after the second, direct
application; calculated half-lives for dissipation following the second application were 1.8 days at
the, AR site and 3.4 days at the LA site. Triclopyr residues in the flood water by the end of the
flood period were 0.015 ug/mL at the Arkansas site and 0.006 ug/mL at the Louisiana site. In the
top 3 inches of the soil, triclopyr dissipated with a "best fit" registrant-calculated half-life of 7.6 '
days at the AR site and 2.9 days at the LA site. Soil concentrations were lower following the
sedond, flooded application; calculated half-lives for triclopyr in the top 3 inches of flooded soil
following the second application were 11.6 days at the AR site and 11.7 days at the LA site.
Triclopyr residues in the soil by the end of the flood period were 0.026 ug/g at the Arkansas site
and < LOQ (0.01 ppm) at the Louisiana site.
Two degradates, 3,5,6-trichloro-2-pyridinol (TCP; pyridinol) and 3,5,6-trichloro-2-
methoxypyridine (TMP; methoxypyridine), were recovered from the water and the soil. The
concentrations of pyridinol and methoxypyridine were greater in the flood waters following the
secohd application of triclopyr TEA. Concentrations of pyridinol were approximately ten times
greater than those of methoxypyridine at all sampling intervals. TCP persisted in the flood water
of rice fields for up to 59 days following the second application of triclopyr TEA; TMP dissipated
mofe rapidly. Pyridinol was found deeper in the soil in Arkansas than in Louisiana (down to 12
inches versus 9 inches); however, at all times, concentrations in the lower depths were near the
limit of quantisation (0.01 ppm). The guideline requirement for the use of triclopyr TEA on rice is
fulfilled. (GLN 164-2; MRIDs 43955901 and 44198101).
V ',. .Forestry
J'S'.i H I " ,; ,..!ซ!, I ,1 ', '" fi1! 1 i,1', , ' ' ,"J " "I I'"1'1' ' " ' '"' tV,1' , " '"I1,:"1'' ,, i,,. , ', v1': " > 1'. ' '
Triclopyr BEE was aerially applied at a nominal rate of 3.84 kg ae/ha (Garlon 4, 480 g
ae/L EC) to forested sites (trembling aspen and balsam poplar) in Ontario, Canada. Residues
were recovered from water as triclopyr BEE, from sediment as triclopyr acid, and as total
triclopyr (triclopyr BEE plus triclopyr) from foliage, soil, litter, aquatic plants, and fish. The
degradate 3,5,6-trichloro-2-pyridinol (TCP) was detected on the foliage and in the soil, litter,
aquatic plants and fish; TCP was not detected in water at any time. The degradate 2-methoxy-
3,5,6-trichloropyridine (methoxypyridine) was detected only in the soil, and then only rarely at or
near the detection limit (0.01 ppm).
I Total triclopyr in foliage was >500 ppm at day 6; it decreased to approximately 200 ppm
and stayed there for the next 29 days (last sampling interval), but variable data thereafter
prevented calculation of a half-life. Total triclopyr (triclopyr BEE plus triclopyr) and TCP
dissipated from the soil with half-lives of 26 and 85 days, respectively; in the soil, total triclopyr
and TCP were detected as deep as 90 cm, and 2-methoxy-3,5,6-trichloropyridine was detected as
deep as 30 cm.
60
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Triclopyr BEE present due to overspray of the stream and transported between sampling
locations in stream water hydrolyzed to trielopyr acid in a matter of hours (4-6 hours); the
maximum observed concentration of trielopyr BEE was 0.35 ppm. Total trielopyr in aquatic
plants decreased with a half-life of 4-11 days; TCP was very low. Total triclo'pyr depurated from
fish with a half-life of 0.6 days;- the maximum observed concentration of total trielopyr was 43
ppm in whole fish at day 0. No quantifiable levels of trielopyr BEE or TCP were found in
sediment; trielopyr acid was not seen after day 3. (MRIDs 41445001 and 44039302)
Triclopyr BEE was. aerially applied by helicopter to clearcut timberland in southwest
Washington at a rate of 6 Ib ae/A (Garlon 4; 4 Ib ai/gallon EC) in 1991. Total trielopyr
.residues (trielopyr BEE + trielopyr) and its degradates 3,5,6-trichloro-2-pyridinol (TCP) and
355,6-lricUoro-2-methoxypyridine (TMP) were detected on the foliage, leaf litter, pond sediment,
and in scarified and litter-covered soil; only total trielopyr residues and TCP were found in stream
sediment. Samples were not specifically .analyzed for trielopyr BEE. Only total trielopyr residues
were detected in the pond and stream waters. The registrant estimated half-lives.for total
trielopyr residues to be 96 days in exposed soil, and 37 days in unexposed soil. In the litter
covered soil, there were sporadic detections of trielopyr acid through the 12-30 inch soil depth
(approximately 30-76 cm); there were no detections below 30 inches throughout the study.. TCP
was detected through the 12-18 inch (30-46 cm) depth; there were no detections below 18 inches
throughout the study. TMP was detected at up to approximately 0.4 ppm in the 0- to 6-inch soil
depth, up to, 0.05 ppm in the 6- to 12-inch soil depth, and was not detected below 12 inches in the
litter covered or the scarified soils. Total trielopyr in foliage was 206-475 ppm at day 0;.the
estimated half-life for total trielopyr residues was 15 days. Other half-lives were 5 days in pond
water, 24 days in pond sediment, and 20 days in leaf litter. The guideline requirement is fulfilled
(GLN 164-3; MRIDs 41445001 and 44039302, and 43011601 and 44039301).
(3) Spray Drift.
No spray drift data are required for the trielopyr acid because the registrant is not
supporting the registration of :any typical end use products containing the acid. No TEA- or
BEE-triclopyr-specific studies were reviewed. Droplet size spectrum (GLN 201-1) and drift field
evaluation (GLN 202-1) studies are required for trielopyr derivatives, since the different
formulations may be applied by aircraft and it is estimated that there will be detrimental effects to
non-target organisms due to drift. However, to.satisfy these requirements the registrant in
conjunction with other registrants-of other pesticide active ingredients formed the Spray Drift
Task Force (SDTF). The SDTF has completed and submitted to the Agency its series of studies
which are intended to characterize spray droplet drift potential due to various factors, including
application methods, application equipment, meteorological conditions, crop geometry, and
droplet characteristics. The Agency is evaluating these studies. In the interim and for this
assessment of trielopyr derivatives, 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
61
-------
" i"'
rtit;;
applications. After review of the new studies the Agency will determine whether a reassessment
is warranted of the potential risks of the application of products containing triclopyr TEA or BEE
ii > ..... ' ' v; >!t[ -,!. ; *,,"' '''-'ih ..... ;:*! " l!': '.;'.': :;; ","'>:' '! ,;,':. :?.',,',"' ?fV ' :i '"';,/' ' M"~ : K ,' ' , V -, ' .'ii: v
d. Water Resources
triclopyr TEA and BEE are the forms applied, both readily form the acid. The acid
arid its degradate TCP are of concern in the ground water assessment. Triclopyr acid is
somewhat persistent, with persistence increasing as it reaches deeper soil levels, where there are
anaerobic conditions; it is also very mobile. TCP is both mobile and persistent. Pesticides with
similar properties have been found in ground water. Due to the environmental fate characteristics
of triclopyr acid, the Agency believes this chemical has a potential, to leach to ground water.
;|if"
id! 11:
! 4't
"'
(1)
Ground Water
Ii! Ill1' Si!' '
TJie Qffice, gf Pesticide jPrpgrams (OPP) evaluates the persistence and mobility of each
pesticide for ground water concerns. If the data indicate that the parent and/or degradates are
pef iistent and mobile, then a small-scale prospective ground water study may be requested. The
basic triggering criteria include:1) weight of the evidence from laboratory and field dissipation
s%tฎs.'W$pif^ฃ^atthe pesticide has properties and characteristics similar to pesticides that are
known to leach or have been detected in ground water; 2) movement of the parent or degradates
7A$P, csntfm^er^j^ough the soil profile or plow layer in a field dissipation study or; 3) reports
of detections in ground water from other monitoring studies and information about toxicity. In
adjitipn, use patterns, application rates, timing of application, potential acreage treated, depth to
ground water, soil types, hydraulic gradient, and climate are also evaluated as part of the
triggering criteria.
Persistence, mobility, and detections in ground water are also used to evaluate a chemical
to determine whether its use should be restricted. A pesticide may be recommended for restricted
use for ground water concerns if it exceeds one or more characteristics for each of the three
factors (persistence, mobility, and detections).
Persistence and Mobility
Triclopyr was evaluated for persistence and mobility in relation to its potential to leach to
ground water. Below is a summary of that evaluation.
62
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Table 30: Mobility and Persistence of Triciopyr Relative to Restricted Use Criteria
factors
', f>,^f.
Persistence
\
Mobility
Cteasferistjc'....
*
Field dissipation half-life
Lab-derived aerobic soil
metabolism half-life
Hydrolysis half-life ,
Photolysis half-life
(soil) " ' .
Soil adsorption: K^ ,
Soil adsoiption: Koc.
Depth of leaching in field ,
'dissipation study , .
Rfestri-cted'ase
- Criteria
> 3 weeks or
> 3 weeks or .
< 10% in 30 days--,
< -or
< 10% in ,30 days
and
5 ml/g or
500'ml/gor
.. , . 75 cm
Triolopyr
BEE
0.2 wks :'-
aid)
18, 172,
5,000%
in 30 days
NA
45 cm
, Tri-cfopvr -
"TEA.
NA
' l-.l, 2:6 wks-
(8, 18 d.)
SM>la ' -
'NA
, 0.165 ~\
0ฃ7$anl/g
,25-134 '/;
, ' ,nปI/g :
* TCP
(degradaie)
> 3 weeks .
i ' > I year
s f *C- f
\" StabJe -
< 1 day
0,53-1.95 :
-isl/g
??^4^
Jid/g
46, 90 cm '
NA indicates No Acceptable data
Ground Water Detections
To date, there has been limited monitoring for triclopyr in ground water in the United
States. The "Pesticides in Ground Water Database" (Hoheisel et al., 1992) reports sampling for
triclopyr in Maine, Texas, Virginia, and .Vermont A total of 379 wells were reported sampled in
four states and 5 wells were found to contain triclopyr residues. One well in Texas contained
0.58 ppb triclopyr and four wells in Virginia were found to contain 0.006 to 0.018 ppb .-of
triclopyr., A summary of this is presented below.
63
-------
lllWI!!;! " ' J1;!"
.":.;. Ta ,,"ii,
III; !,|'(,i:,;I j|';',;;., ,1, Table 31: Summary of Ground Water Detections
J'ilii"" i HI'!1:1-1 i" ft"' , *
.,' Factor "
Detections
^ * *'\ ^^, s *" "* -j
, Characteristic
Number of wells per state with
detections
Number of counties with detections
> 10% of reference point
- HestrfetedXJse Criteria
25 wells in 4 or more
states or
3 counties at > 10% of
MCI, or HAL
departed Detsetfoas
5 wells in 2 states
NoMCLorHA
Established
fii'Jl1111"'
.111!.;:'
General Conclusions on Ground-Water Quality
Although the environmental fate data are incomplete, triclopyr exceeded the triggers for
mobility and persistence used to recommend restricted use based on ground water concerns.
Triclopyr does not meet the detection triggers for recommending restricted use because of limited
Monitoring data. To date, there has been limited monitoring for triclopyr residues in ground
water in the United States (Hoheisel, et al., 1992). Three hundred and seventy-nine wells were
reported as sampled for triclopyr. Five detections of triclopyr residues in ground water have been
reported in two states. All were very low, the maximum concentration reported was 0.58 ppb.
Ground Water Reference Points
ill I i , .;:" , s.;'t ,' " ' ,
I,;, ., Triclopyr is currently not regulated under the Safe Drinking Water Act (SDWA). EPA's
Office of Water has not estab'Ushed^a.iyjia^iJim Contaminant Level ,(MCL) or a Drinking Water
Lifetime Health Advisory Level (HAL) for triclopyr in drinking water. An estimated HAL can be
calculated from the;Reference pose, EF^DL estimates(,|Jief Lifetime 44ult HA for triclopyr to be
3f>0 ppb. Public water supply systems are not required to sample and analyze for triclopyr.
Field Dissipation Study Summaries
A field dissipation study conducted hi North Carolina found triclopyr residues at 30-40
ppb in the 30-45 cm soil sampling interval at 7 days and 2 weeks after treatment. In the same
stupy, TCP residues were found at 30 ppb at the 30-45 cm soil sampling interval at 8 weeks after
tre||rflien^ A California field dissipation study found the majority of the triclopyr residues in the
0-6 inch sampling interval, however mere were also detections of the degradate TCP in all five
composite samples at the 24-30 inch depth. Residues in these deeper samples ranged from 50 to
120 ppb. This data suggests there may be limited leaching of triclopyr and TCP under some
conditions, however, this evidence is not strong enough to require a ground water study.
64
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(2) Surface Water
.Information froiri acceptable environmental fate studies discussed previously indicates
triclopyr is non-persistent in surface waters (aquatic field dissipation half-lives of 0.5 and 3.5 days
for surface and aerial applications, respectively for Lake Seminole, Georgia). In aqueous
environments, triclopyr TEA salt dissolves rapidly (less than one minute) to triethanolamine and
triclopyr acid, and triclopyr acid then dissociates to form the triclopyr anion (pKa = 2.93).
Laboratory studies indicate triclopyr is non-persistent .(aqueous photolysis half-life of 8-9 hours
for pH 7 sterile buffered solution; half-lives in river water ranging from 0.7-1.7 days). In aqueous
systems, the hydrolysis of triclopyr BEE is base-catalyzed and varies from stable at acidic
conditions (half-life of 84 days in sterile pH 5 solution) with decreased stability (half-life of 7
hours) observed under basic (pH 9) conditions. In natural waters, triclopyr BEE hydrolyzed
rapidly (half-life of 0.5 days at pH 6.7) to triclopyr acid.
Triclopyr acid is stable to abiotic hydrolysis at pH 5, 7, and 9; however, photolytic
.degradation in aquatic environments is rapid. The vapor pressure and Henry's Law, constant
indicate triclopyr should "not readily volatilize from surface water environments. Based on the
Freundlich adsorption coefficients (Kads range: 0.165-0.975 mL/g), triclopyr does not adsorb to
soil and sediment particles, and may be transported in surface runoff waters. However, triclopyr
is not predicted to persist in surface waters because of the rapid photolytic degradation in aquatic
environments. , s
. \ -
Monitoring information is not available frdm,Storet, however there is partially acceptable
and supplemental information from two forestry studies. Limited .surface water monitoring data
for triclopyr in stream and pond water was reported in a southwest Washington forestry
dissipation field study (3VCRID #43011601). At 3 days post-treatment, triclopyr was measured at
23.2-25.1 ^g/L in stream water which was not directly treated. These data suggest triclopyr was
transported to the stream location through spray drift associated with the aerial application.
Triclopyr and its degradates TCP and IMP were not detected (detection limit of 10 //g/L acid
equivalents) at any other sampling intervals in the stream .water. Two sediment samples contained
10.7rl4.9^g/Kg at 3 days post-treatment. Triclopyr was measured in sediments at 26.4 and 12.6
jUg/Kg at 4 weeks and 3 months, respectively. For the pond water that was directly oversprayed
with triclopyr, concentrations were 1.99-2.10 mg/L immediately posttreatment, 0.492 -0.776
mg/L at 7 days, .0.0345-0.0380 mg/L at 4. weeks, and <0.0100 mg/L (detection limit) from 3-8
months. In the pond sediment, triclopyr was 0.467-0.830 mg/Kg immediately posttreatment,
0,613-1.55 mg/Kg at 3 days post-application, 0.369-1.22 mg/Kg at 14 days, and 0.270-0.334
mg/Kg at 4 weeks.
Triclopyr BEE was aerially applied at a nominal rate of 3.84 kg ae/ha(Garlon 4,480 g
ae/L EC) to forested sites (trembling aspen and balsam poplar) in Ontario, Canada. Residues
were recovered from water as triclopyr BEE, from sediment as triclopyr acid, and as r) from
foliage, soil, litter, aquatic plants, and fish. The degradate 3,5,6-trichloro-2-pyridinol (TCP) was
detected on the foliage and in the soil, litter, .aquatic plants and fish; TCP was not detected in
, . ,'"'65"' . - , - -
-------
fr. '*Ff: i wi'.. '<>!!.": II! ':',,:.':;" 'I',;';:'I!'.' v^1!':.;..,i* \\:-':;''.; ''i^:-^:;.' I-!'''
f' ',;; .^ซr,st.any time. The degradate 2-methoxy-3,5,6-trichloropyridine (metiioxypyridine)was
detected only in the soil, and then only rarely at or near the detection limit (0.01 ppm).
Triclopyr BEE present due to overspray of the stream and transported between sampling
locations in stream water hydrolyzed to triclopyr acid in a matter of hours (4-6 hours); the
maximum observedconcentration of triclopyr BEE was 0.35 ppm. Total triclopyr in aquatic
plants decreased with a half-life of 4-11 days; TCP was very low. No quantifiable levels of
, or TCP were found in sediment; triclopyr acid was not seen after day 3.
In a supplemental journal article (Thompson et al., 1995) the environmental fate and
ecological effects of triclopyr BEE were studied in a first-order forest stream in Ontario, Canada.
Maximum concentrations of tiiciopyr BEE in stream water samples were 0.848 and 0.949 /zg/mL
at |jyo saipplmg locations at 10 and 20 minutes after direct injection into the stream. Triclopyr
BEE dissipated rapidly, with stream water concentrations decreasing to below 0.1 ,ug/mL within
60-70 minutes following injection. The study authors concluded flowing water systems such as
the forested watershed monitored iiq this study would result in rapid dissipation of triclopyr BEE
and triclopyr acid.
Expected Aquatic Concentrations
The Agency calculated generic EECs using the GETSferic Expected Environmental
Concentration Program (GENEEC). These generic EECs are designed as a coarse screen and
estimate expected concentrations from a few basic chemical parameters and pesticide product
label application information. These estimated environmental concentrations are then used as an
estimate of the exposure to nontarget aquatic animals in a first-tier screen for risk assessment
(section C.3.(a)(2)).
GENEEC is a model designed to mimic a PRZM-EXAMS simulation. It uses a chemical's
soil/water partition coefficient and various degradation and metabolic half-life values to estimate
nmofTfrorn a, lO-hectare field into_ai|iii-hecfare,water bqdy, 2 meters deep. GENEEC calculates
generic estimated environmental concentration (GEEC) values that are used for both acute and
chronic risk assessments. It considers reduction in dissolved pesticide concentration due to soil
incorporation, degradation in soil before a rainfall event, adsorption of pesticide to soil or
sediment, and degradation of the pesticide within the water body. It also accounts for direct
deposition of spray drift onto the water body.
.; Input values were obtained from studies submitted to the Agency and the open literature
and are discussed earlier in this document. The Agency assumed all applications were a single
application at the maximum use rate for a site, with no soil incorporation. Spray drift at 100 feet
downwind is assumed tp be 1% of the application rate for ground applications and 5% of the
application rate for aerial applications. ,
66
-------
Because the TEA salt dissociates to the triclqpyr acid and TEA within one minute of
dissolving* in water, it is expected that only the acid will be present in runoff from areas treated
with triclopyr TEA. It is therefore appropriate to use the chemical and environmental fate data
for triclopyr acid in the GENEEC program. The K0? was estimated from the arithmetic mean of
high and low values for triclopyr acid; the value for the aerobic soil metabolism half-life was the
longer of the two available.
The following data were used for input into the GENEEG Program for the TEA salt: -.
- Soil Organic Carbon Partitioning Coefficient (Koc): 204.
- Aerobic soil metabolism half-life: 18 days. ,
- Aerobic aquatic metabolism half-life: 142 days.
- Photolysis Half-life (at pH 7): 0.6 days. ;-
- Water Solubility: 440 ppm. . .
Table 32: Estimated Environmental Concentrations (EEC) for Triclopyr TEA
-",'",".,> Ground Appli-caffon. , '' ' "
RATE
(Ifos ae/A)
1.0 '
3.158
9.0
12.12
PEAK EEC (ppb)
30
95 >
270
364
DAY 21 EEC (ppb)
25
80
227
305
Day 56 EEC (ppb)
19
61
... 173
233
, Aerial Application ' - -, , ,
6.0
186
156
119
The environmental fate data set is incomplete for the BEE ester; no data were available for
either the aerobic soil or aerobic aquatic metabolism half-life. However, it was possible to
generate GENEEC values by making the worst-case assumption that triclopyr BEE was stable to
aerobic soil metabolism. The Koc was a reported estimate for triclopyr BEE (Meylan and
Howard, 1992). . . :
67
-------
;, sill*
The following values were used for input into the GENEEC Program for the BEE ester:
- Soil Organic Carbon Partitioning Coefficient (Kop): 560
- Aerobic soil metabolism half-life: Stable (GE^EC input = 0)
- Aerobic aquatic metabolism half-life: No available data (GENEEC input = 0)
-Abiotic hydrolysis half-life (at pH 7): 8.7 days.
- pBotoiysis Half-life: 6.6 days.
- Water Solubility: 6.84ppm.
Table 33: GENEEC Aquatic Estimated Environmental Concentrations for Triclopyr BEE
" ' III! ' ' I '
! * ^* * ^/*i'j*v ' / '*- '" ' *
A ':;.,.,,,,," \ I,,-" v, i,x,\ , ^rotind AppIicatHMi
RATE (Ibs ae/A)
1.0
3.0
8.0
12.0
i i [ f Jl-jj *w j jv & ,v,v Stiff j < f *
- ," , "" ' - AigซaJA
1.5
8.0
PEAK EEC (ppb)
19
57
152
228
ipli(iation
30
160
In order to run GENEEC, a minimal input data set is required. An essential data input is
the aerobic soil metabolism half-life. Since this value was not available for the BEE, the EECs, in
the above table reflect the assumption that triclopyr BEE was stable to aerobic soil metabolism.
We know from other laboratory and field data that triclopyr BEE degrades in soil to triclopyr with
a half-life of less than a day (half-life of 3 hours in laboratory soil, supplemental info from MRID
00134174; half-lift^ of 1.1 days in field" soil, MRID 43033401)! These observations would indicate
that the predicted peak EEC values for triclopyr BEE listed above are higher than what would be
expected to occur in the environment.
In addition, as calculated above, any decrease in the estimated aquatic concentrations of
triclopyr BEE with time would be due only to abiotic hydrolysis and photodegradation. We know
that triclopyr BEE hydrolyzed to triclopyr acid/anion very rapidly in natural waters in the dark
(half-life of 0.5 days, 3VDEUD 00134174); therefore, it is not expected that there will be any
triclopyr BEE remaining in the model water body after only a few days. Therefore, the 21- and
56-day GEEC values generated during the running of GENEEC with the above parameters were
not reported in the table above.
68
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4. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Risk Quotients (RQs) and the Levels of Concern (LOCs):
Risk characterization integrates the results of the exposure and ecotoxicity data to
evaluate the likelihood of adverse ecological effects. The means of integrating the results of
exposure and ecotoxicity data is called the quotient method. For this method, risk quotients are
calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic.
RISK QUOTIENT = EXPOSURE
ECOTOXICITY ,
Risk quotients are then compared to OPP established levels of concern. These LOCs are
criteria used.by OPP to indicate'potential risk to nontarget organisms and the need to consider"
regulatory action. More specifically, the criteria indicate that a pesticide, when used as directed,
has the potential to cause adverse effects on nontarget organisms. LOCs currently address the
following risk presumption categories:
o acute high risk - potential for acute.risk is high; regulatory action may be warranted in addition
to restricted use classification . '
0 acute restricted use - the potential for acute risk is high, but this may be mitigated through
restricted use classification
o acute endangered species - the potential for acute risk to endangered species is high; ,
regulatory action may be warranted .
o chronic risk - the potential for chronic risk is high; regulatory action may be warranted ;
Currently, 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. ' - -
The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic.
risk quotients are derived from the results of required studies. Examples of ecotoxicity values
derived from the results of short-term laboratory studies which assess acute effects are:
- LC50 (fish .and birds) '
- LD50 (birds and mammals)
- EC50 (aquatic plants and invertebrates) ' <''
- EG25 (terrestrial plants)
- EC05 or NOEC (endangered plants)
69
-------
Ml lllllll 111III III III II11 III
'IS''!!','!"SI"ill"'1"* 1 "rWi'M'l-1-;"!1 Vfl III!I'!,!!"!'1 IflUW Til! I!
,'i: " , ';, .,..'./iit i . IF sr, 1- v I1 ;;|
; .;,;; ;; Examples of toxicity test effect levels derived from the results of long-term laboratory
studies which assess chronic effects are:
- LOEC (birds, fish, and aquatic invertebrates)
- NOEC (birds, fish and aquatic invertebrates)
- MATC (fish and aquatic invertebrates)
Generally, for birds and mammals, the NOEC value is used as the ecotoxicity test value in
.;' ; assessing chronic effects. Other values may be used when justified Generally,, the MATC
(defined as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in
;'./ .' as||งs|ng; chronic effects to fish and[aquatic invertebrates. However, if the measured end point is
reproduction or survivability then the NOEC is used.
I",;,;!'['!, ;'; I';! I'!' Risk presumptions, along with the corresponding risk quotients and levels of concern, are
'' "Ti!" '"it , tabulated below. ' ,", \. ',, . ," ,.' ' , "",',. ".
Table 34; Ecological Risk Presumptions, Risk Quotients and Levels of Concern
Risk BresumptioH
** s ** ? * *v '
&isk {Quotient
Level of Concern
Birds
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC'/LC,n or LDw/sqfF> or LD,n/day3
EECfi.Cn or LD50/sqft or L.D50/day (or
LD,0<50mg/kg)
EEC/LC<0 or LD50/sqft LD,n/day
EEC/NOEC
0.5
0.2
0.1
1
Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC,0 or LD50/sqft or LD,n/day
EEC/LCs0 or LD50/sqft or LD^/d'ay (or
LD,0<50mg/kg).
EEC/LC,0 or LD50/sqft or LDซ/day
EEC/NOEC'
0.5
0:2
0.1
1
abbreviation for Estimated Environmental Concentration; designated as ppm in avian/mammalian food items
LDW* v-lof bird
* mg of toxicant consumed/dav
LDJO*wt.ofbird
70
illlllllllilii!!!'!','!::!' illllii; Mali, !;
-------
Table 35; Aquatic Animals Risk Presumptions and Levels of Concern
~ $8sk Presumption
Acute High Risk
Acute Restricted Use '
Acute Endangered Species
Chronic Risk
'' Ei&kQaotteirf
EEC'/LC^orpC,,,
EEC/LC,0orEC<0 , '
EEC/LC,0orEC,n ' '
EEC/MATC or NOEC '
JueveJ of .Ooseeoj
0.5 .
0.1
0.05
1
1 abbreviation for Estimated Environmental Concentration; designated ppb/ppm in water
Table 36: Terrestrial and Semi-Aquatic Plant Risk Presumptions and LQCs
K.jsfc'Fxs5timp1;ba
Acute.HighRisk
Acute Endangered Species
Sjsk Quotient % " "" ,
EEC^C,, ...-.-
EEC/EC0,orNOEC ' . /
L^Vel -qf
Coiicern
1 -
U
' Aquatic- Plants . ' .'".
Acute High Risk '
Acute Endangered Species
EECป/ECW ' ' ' .'
EEC/EC05orNOEC -
1
l '
1 abbreviation for Estimated Environmental Concentration; designated Ib ae/A
2 abbreviation for Estimated Environmental Concentration; designated ppb/ppm in water
(1). Exposure and Risk to Nontarget Terrestrial Animals
For pesticides, such as triclopyr TEA and BEE, applied as a non-granular product (e.g.
liquid, dust), the estimated' environmental concentrations (EEC) on food items following product
application are compared to LC50 values to assess risk. The predicted 0-day maximum and mean
residues of a pesticide that may be expected to occur on selected avian or mammalian food items
immediately following a'direct single application at 1 Ib ae/A are tabulated below.
71
-------
Table 37: Predicted Environmental Concentrations on Terrestrial Foods
" 'I i 1 "i !',',', ,'i'^K ,&" " fe -. , '>f
FGoa Items
j II vc s ' ..
Short grass
Tall grass
Broadleaf/forage plants, and small insects
Fruits, pods, seeds, and large insects
SEC(ppm)
Prej^cledMaximitni Residue
240.
110
135
15
- EEC (ppffi)
Predicted Mean Residue ,
85
36
45
7
1 Predicted maximum and mean residues are based upon a 1 Ib ae/a application rate and are based on Hoerger and Kenaga (1973) as
modified by Fletcher et a! (1994).
'' ,,'"("" :' VM n,,,'': k ,!,! , ' '
r For pesticides, such as triclopyr TEA, applied as a granular formulation, the estimated
environmental concentrations (EEC) following product application is compared to LD50s/ft2
values to assess risk. Birds may be exposed to granular pesticides by intentionally or
inadvertently ingesting granules when foraging for food or grit. They also may be exposed by
other routes, "such as by walking on exposed granules or drinking water contaminated by granules.
The risk quotient for granular pesticides is calculated by dividing the milligrams active ingredient
per square foot (mg ai/ft2) by the LD50 mg/ai/bird. Risk quotients are calculated by using a 178-
gram bobwhite quail (Dunning 1984).
1 " , ,ซ' ,, i ,,,,'.'i , " ', P! 'I i"::'!! ' '" ,,;,"' I.',. ,JI',il|;.i ' " . ' . '",.,. ' .. ,,'|..i, '. "' ' . . ', ' ' ; !, "i; .. I ' . ;
(a). Birds
AcuteRisk
The acute risk quotients (RQ) for broadcast applications of non-granular products are tabulated
below.
I-?if '! '!
VIE '.:-
."' '.',(:: : -,.',':
''Mil .'M'!',I ;, "
1 |,:.||!>", "MI. mi!':; 11,,,; j:> i ,,,i
i M; .i', i 11 .iii j. 1.:,,.; !ii, sii j"i i '!iij; ,ii,;, i,. in '"jjii. iiiiiiiiiiiiliii, gir,. AW I'liiii,',;' ii1:1 'fi
-------
Table 38: EECs and Dietary Risk Quotients with Triclopyr TEA for Birds
:ฃ?^
,
Short
Grass
Long
Grass
Broad
leaf
Plants
and
Small
Insects
Fruits,
Pods,
Seeds,
Large
Insects
ESC
RQ '
.J.-O'&sa&A
240
-.110
135
15
0.04
0.01
0.02 '
0.00
>
EEC-
is &s
360
165
202
22 .
i RQ
ae/A
0.07
0.03
0.04 .
0.00
EEC
*
M85 lfeae/A -^
757
;347
426
47
0.14 .
0.06
0.08
0.01
"EEC f
m-
&DIbs ae/A
1440
660,
810
90 '
0.27
0.12
0.15
0.02
'EEC
Rq
JWJb.** '
2160-
990
1215
135
0.40
0.18
0.23
0.02
EEC '
:ป. -
12.12 $s ae/A
2908
1333
1636
'
181
0.54
0.25
0.31
0.03
Notes: ' ' . ' ''
EECs are given in parts per million,(PPM). - -
EECs reflect maximum predicted residues b'ased on 1 Ib ae/A application rate , based on hoerger and Kenage (1973) as modified by
Fletcher, et al. (1994). .-.., . ' '. , ", .'-'".
Most sensitive bird species (quail) LG50= 11,622 ppm = 5357 ppmae . ' ' '
Factor for conversion of ai to ae is 0.7125 , based upon the percentages of active ingredient to acid equivalents specified on product
labels. ' . . ' ,
To calculate acid equivalents: "; . . '
11,622 (LC50 most sensitive species) x 0.647 (% ai in formulated product) x 0.7125 =-- 5357 ppm ae.
>. - ' /
The results for triclopyr TEA applications indicate the following : -
o Acute levels of concern (^LOC) were exceeded only for birds feeding on- short grass
with application of 12.12. Ib ae/A. , ; . '
o LOCs are exceeded for endangered species of birds at rates > 3.185 Ib ae/A for birds
that feed on short grass and >6.0 Ib ae/A for birds feeding on long grass, broadleaf plants,
and small insects.
oLOCs are exceeded for restricted use candidate at rates of application >6.0 Ib ae/A.
73
-------
Table 39; EECs and Dietary RQs for Birds with Triclopyr BEE
> | ^ ood Items
Short Grasses
Long Grasses
Broadleaf
Plants and
Small Insects
Fruits, Pods,
Seeds, Large
Insects
EEC
HQ
l.Olbsae/A
240
110
135
15
0.06
0.03
0.03
0.00
EEC
M
1.51bsae/A
360
165
202
22
0.09
0.04
0.05
0.01
'BBC'
RQ
8,0 Ibs ae/A
1920
880
1080
120 '
0.49
0.23
0.27
0.03
\ "BEO
&Q -:
12.0 Ibs ae/A
2880
1320
1620
180
0.74
0.34
0.42
0.05
Notes: , , .. . ,
EECs are given in parts per million (ppm).
LC50 = 5401 ppm, equivalent to 3884 ppm ae.
^i^iicted majdmum residues are based upon a 1 Ib ae/a application rate and are based on Hoerger and Kenaga (1973) as
modified by Fletcher etai (1994). .'
Factor for conversion of ai to ae is 0.7192, based upon the ratio of percentages of active ingredient to acid equivalents as
specified on product labels.
The results for triclppyr BEE applications indicate the following:
.:, i.1' , ,':; '.. tl!':.';.. .... >-lr-i; ::J': i'' ^.WiV.*.' r-'ปt:'';;'$:-{ii^'":4il l< '' \ ' V v
o No acute levels of concern for avian species, on an acute dietary basis, are exceeded at
<1.5 Ibs ae/A application rates.
o The 8 Ibs ae/A use rate exceeds the level of concern for restricted use on short grasses',
long grasses, and broadleaf plants/small insects. Additionally, triclopyr BEE exceeds the
levels of concern on short grasses, long grasses, and broadleaf plant's/small insects for
acute risk to endangered avian species.
\ ' ; ' .
o The 12 lbs"ae/A use rate on short grasses exceeds the level of concern for high acute
risk to non-target avian species. Additionally triclopyr BEE concentrations on long
'~2"'", I grasses, broadleaf plants and small insects exceed the level of concern for restricted use
;; i criteria. Tjiclppyr BEE concentrations on short and long grasses, broadleaf plants and
" :: small insects exceed the levels of concern for acute risk to endangered avian species.
-HiMl . ' i,"'!'>;, - '.i'i . i until f '.' ' ;'.;' i :: "il ' ' :\ . ' i1- ; )?' ": :- ,;1"1..1 (.:' !"'.. ";i." .1 ..' S"'1"' ; r , ..!?. ,.
Acute Exposure to Birds from Granular Formulation of Triclopyr TEA
'T. ". The granular formulation of triclopyr TEA is used at 0.54 ib ae/A on turf (based on LUIS
report) as a weed and feed formulation that is broadcast applied. The most sensitive single dose
74
-------
LD50 for triclopyr TEA was'2055 (3176 mg/kg x 64.7% formulation) mg ai/kg (1464 mg ae/kg)
for the mallard duck.
The weight of a mallard duck is 1.082 kg (Dunning, 1984). LD50 in mg ae/birdis 1,584 mg
ae/bird as shown below. ._'
' LD50= 1464 mg ae/kg ^ , ..-.".'.-
. 1.082 kg = mallard weight ,
1464 mg ae/kg x 1.082 kg/bird = 1,584 mgae/mallard duck
The milligrams per square foot is calculated as follows:. ' ..
0.54 Ibae/A for turf x (453590 mg/lb -43 560"fl?/A) = 5.6 mg/ft2 .
The single dose LD50 per square foot is calculated as follows: ' ' "
5.6 mg/ft2/(1464 mg ae/lcg^x L082 kg/bird) = 0.004 LD50/ft2 per mallard bird
The single dose LD50/ft2of.0.004 does not exceed any level of concern.
Chronic Risk for TEA and BEE ; '
The chronic list quotients for broadcast applications of non-granular products are
tabulated below.
75
-------
Table 40: EECs and Chronic RQs with Triclopyr TEA for Birds
'II I
Food Items
Short
Grasses
Long
Grasses
Broadleaf
Plants and
Small
Insects
Fruits,
Pods,
seeds,
Large
Insects
EEC
RQ
l.Olbsae/A
240
110
135
15
2.4
1.1
1.35
0.15
EEC
RQ
1.51bsae/A
360
165
202
22
3.6
1.65
2.0
03.
EEC
&Q
3.185 Ibs ae/A
758
347
426
47
7.6
3.5
4.3
0.5
EEC
RQ
6.0 Ibs ae/A
1440
660
810
90
14.4
6.6
8.1
0.9
EEC
RQ
9.0 Ibs ae/A
2160
990
1215
135
21.6
9.9
12.2
1.35
EEC
RQ
12.12 Ibs ae/A
2908
1333
1636
181
29.1
13.3
16.4
1.8
;::::'=: ; "':': :":' ' Notes: "" ' '
"' \',\" ' '_ "; BECs arc given as parts per million (ppm).
'I ป|';:::;;;,;j'*ji-;;" ;, Jซ "' (^cpiatKUisarc based p^'lnclopyr acid NOEC - 100 ppm ae.
"I i''1;'' 's!!'!'';" i* ''"Predicted maximum residues are based upon a 1 Ib ae/a applieati
Fletcher etal (1994).
upon a 1 Ib ae/a application rate and are based on Hoerger and Kenaga (1973) as modified by
III
The results for triclopyr TEA applications indicate the following:
o The chronic level of concern was exceeded for > 9.0 Ibs ae/A use rates for birds feeding
i' 'i'1"." ii'Mfi "i ' <';:? .l"1.,11/.' ;"!,',' '.>'-:\. (:'. I'-M'jp, !;;'..,' ;': .'.:,~.,..i.. ,. :. , -,w , r , . ฐ
On the fruits, pods, seeds, and large insect food items. However the chronic level of
concern was exceeded for birds feeding on the other food items at all use rates. '
o Chronic risk,from granulars can not be estimated due to the uncertainties related to
exposure.' For example, no data are available to characterize the release rate of ttie
pesticide from the granular base material (carrier).
i . ii ..... i
..'.' . ,
Although, there will be an initial level of triclopyr BEE mat birds may be exposed
to, triclopyr BEE rapidly hydrolyzes to triclopyr acid/anion in the environment. Chronic
effects from a limited duration of exposure to triclopyr BEE are unknown. However, any
effects from long term exposure due to the use of triclopyr in any form is probably due to
the acid/anion. Therefore, the risk assessment will use the values for the triclopyr TEA
(equivalent to the acid/anion) to estimate the chronic risk quotients for triclopyr BEE.
An avian reproduction study is not needed for triclopyr BEE.
;, , _' i;;,)!,! i ; , ,, i i ,,k; :,_!,;: i,;;;',11'' i -"' ; , ,"T*^,V;:' :", '' '' ;" , : '*.
-------
(b). Mammals
Granular Products - Acute and Chronic Risk
The granular formulation of triclopyr TEA is used at 0.54 Ib ae/A on turf (based on use
information) as a weed and feed formulation that is broadcast applied. Mammalian data indicate
that mammals are less sensitive to triclopyr than birds. Since it was determined that there is no
risk to birds from the use of currently labeled grarmlar products of triclopyr TEA, it is reasonable
to assume that there will be no acute risk to mammal species from the use of the above granular
products.
Chronic risk from granulars can not be estimated due to the reasons stated above.
Non-granular Products - Acute Risk ".-',.
The assumptions of this analysis are:
The various forms of triclopyr are considered bioequivalent with regard to toxicity.to
mammals. Therefore, the rat LD50 of 630 mg/kg will be used to. assess acute risk to mammals for
all forms of triclopyr. ,
Estimating the potential for adverse effects to wild mammals is based on a 1-day LC50
calculated from the rat LD50. The concentration of triclopyr in the diet which is expected to be
acutely lethal to 50% of the test population (LC50) is determined by dividing the LD50 value
(usually rat LD50) by the percentage (decimal) of body weight consumedr It is assumed a young
rat consumes approximately 10% of its body weight per day (Lehman, A. J., 1959). A risk
quotient is then determined by dividing the EEC by the derived LC50 value. ,
Exposure will be based on a nomograph developed from by Hoerger and Kenaga (19,73)
as modified by Fletcher et al. (1994). : , .
Acute Assessment
The acute risk quotients for broadcast applications of non-granular products are tabulated
below.
Table 41: Mammalian Acute RQ for Single Application of Triclopyr
"Apj&
Rale
<8* '
ae/A,)
12.12
- %B0dy
Wซ?%1tf
Coftswaed..
v .
10
: w*ซx
,,IAป ,
($>pm>-
'
6300
EEC
(PPM)
Start -
Grass
2,909
EEC (PPM)
Forage...
Small
Inseefe
1.636
EEC (PPM}
FtmtPods,
Large
Ijnsecfs
182
Acute !
UQ !
Sfeart
- -Ofasa '
0.46
Acrte RQ
For.aeซ
&SaปB ;
Inseot*
0.26
Acute R
-------
Table 41; Mammalian Acute RQ for Single Application of Triclopyr
Appf,
Rate
(lis
,ซ^A>
9.0
6.0
3.185
1.5
%Body
Weight
Consymsd
10
10
10
10
J-J5ay
ซ*
Cppm)
6300
6300
6300
6300
EEC"
{EPM)
Short ,
Grass
2,160
1,440
764
360
EECCPB^f
-Forage. _
Smafl
Jfjssctg '
1,215
810
430
203
BECCEEW&
Jmt,:FQ -
Fw?t5 Pods,
L-aarge
Insects.
0.02
0.01
0.01
0.00
li lilt , ! .!:
I'll1 ill,!!1'",'!11.;!! 'h
Notes;
Calculations are based on a rat LD50 value of 630 mg/kgae.
The equation for the RQ is:
: ;. EEC - EEC
LC50 630mgae/kg/dayx( 0.10 kg body weight 1
1! 0.010 kg food consumption
III Small Mammal rherbivore/insectivore/granivore> Acute Assessment
tit! i| ' v:',;.'',-;, ': Spi .'|; :,; ' ,,; ,. ;- ; B i n;-;, ; \ R ;; nr. "[, ,'i" >:'.. ซ.,.ป i;.1,:' iJ- , -, "''T".' . ,, / . ,
o The LOG for aajte high risk for triclopyr is not exceeded at any of the rates of application.
o There were LOG exceedences for the restricted use criteria on short grass at 12 Ibs ae/A and on
forage and small insects at use rates of 6 Ibs ae/A and above.
o There were LOG exceedences for acute risk to endangered species on short grass at the use
rates of 3 Ibs ae/A and above, and on forage and small insects at use rates of 6 Ibs ae/A and
above. . i , t i 11 _, ivi>_
o There were no LOG exceedences for fruits, pods, and large insects at any currently-registered
use rate up to 12.12 Ibs ae/A.
Mammalian Non-Granular Products Chronic Risk Assessment
The chronic risk quotients for broadcast applications of non-granular products are
tabulated below.
78
-------
Table 42: Mammalian Chronic RQs for Single Application of Triclopyr
AppiiesfeJ
Bate ' ,". '"..
(IBs ae/A) -
12.12
9.0
' 6.0
3.185
'. 1.5
jEBCs
>(ppa)
Short.- -
.Orass
2,909
2,160
1,440
764
360
BBC (ppm)
borage, Small
lisects-
1,636
. 1,215
810
430
203 '
EEC (pps),
Emit, Pods,'-
Lsrge Bisects '
182
. 135
'90, :
"'48 :
23
Chrosic
RQ S&ort
'<3rass
11.64
8.64
5.76
3.06
1.44
OtfraaicEQ ,
Forage
& Small
Insects
6.54
4.86
3.24'
1.72-'
0.81
Chrome- RQ
'Fndt, Pods,
Large ,
fesecls
0.73
0.54
0.36
0.19
0.09
Notes: , ' '
Calculations are based on a rat NOEL of 25 mg ae/kg/day (250 ppm/ae)
The equation for the RQ is: .
EEC = EEC '''.."',-'
LC50 . 25 mg ae/kg/day x ( 0.1 Okg body weight }
0.010 kg food consumption
Conclusions - Small Mammal fherbivore/insectivore/grahivore) Chronic Assessment
o The results, based on chronic RQ's on short grass, indicate that for broadcast applications of
non-granular products, the chronic risk level of concern (1.0) is exceeded for small mammals at all
use rates greater than and including the 1.5 Ibsae/A use rates.,
o The results, based on chronic RQ's on forage and small insects, indicate that for broadcast
applications of non-granular products the chronic risk level of concern (1.0) is exceeded at all use
rates greater than and including the 3.185 Ibs ae/A use rates.
i - .
o There were no chronic LOG exceedences for fruits, pods, and large insects at any currently-
registered use rate up to 12.12 Ibs ae/A.
(C). Insects
Currently, the Agency has no procedure for assessing risk to nontarget insects. Results of
acceptable studies are used for recommending appropriate label precautions.
(2). Exposure and Risk to Nontarget Aquatic Animals
GENEEC: '
79
-------
The Agency calculated generic EECs using the GENeric Expected Environmental
Concentration Program (GENEEC). The resultant GEECs are used as a first tier screen for
assessing acute and chronic risks to aquatic organisms. Acute risk assessments are performed
using either 0-day GEEC values (single application) or peak (GEEC) values (multiple
application). Chronic risk assessments are performed using the 21-day GEECs for invertebrates
and 56-day GEECs for fish. However, as discussed in section C.2.c.(3) under Expected Aquatic
Concentrations, we do not expect any triclopyr BEE to remain in the water longer than a few
days. Therefore, only acute assessment can be made for the triclopyr BEE. In all cases, a single
application is assumed. GEECs are tabulated below.
Aquatic Exposure:
, Triclopyr TEA has the following aquatic uses: Drainage systems, forestry, rights-of-way and
rice; For these use patterns, EFED assumes simple dilution of the amount applied to a surface
acre of water at depths varying from 6" to 61. A 21-day and a 56-day EECs cannot be determined
for the direct application to water scenarios.
Table 43: EECs for Aquatic Exposure to Triclopyr TEA
Li:* '(|;S
.jfl ,.
iril.
ซ1 II:,
Site
II h II , ' i" iljjlj * 0 <^ >' ',
' Method
AppSeatiOB/
ฃftฃfid!
/f^pA-I^
EEC (ppni)
23 -day EEC
: (ppsi)
GENEEC
pastures, rangeland, non-ngricultural rights-
of ways, fcncerows, hedgerows,
nonagricultunil uncultivated areas/soils
non-tfiricultural rights-of-way, nonagriculniral
uncultivated areas/soils
pastures, rangeland
ornamental lawns and turf
pastures, rangeland
ground
aerial
12.12
9.0
3.158
1.5
6.0
0.364
0.270
0.095
0.045
0.185
0.305
0.277
0.080
0.0375
0.156
0.233
0.173
0.061
0.029
0.11
DIRECT APPLICATION TO 6 INCHES OF WATER
forest
drainage systems
rice
aerial
ground
ground
ground and
aerial
4.0'
12'
91.
0.3751
, 2,936
8.808
6.606
0.275
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
t. E8Cป we bปjซJ on one direct nppKrafcon to 6 indies of water. EEC "use rate in Ihs ae/A X 734 pbh
80
-------
Table 44: EECs for Aquatic Exposure to Triclopyr BEE ,
Site
I Application
Method
AgpfettQa
' , Safe
(fbs-ae/A) "
Jnittai
(PSAK)>EC
Cppra)
GENEEC
agricultural/farm-slruotures/buildings and equipment,
iencerows/hedgerows, non-agricultural rights-of-way, nqn-
' agriculture uncultivated areas/soils
pastures, rangeland
pastures, rangeland, industrial areas (outdoor), non-
agricultural rights-of-ways/fencerows/hedgerows, non-
agriculture uncultivated areas/soils
ornamental lawns and turf ;
i
non-agricultural rights-of-ways/fehcerows/hedgerows ,
/
pastures, rangeland, industrial areas (outdoor), non- '
agricultural rights-of-ways/fencerows/hedgerows, non-
agriculture uncultivated areas/soils
ground
aerial
. . aerial
12.0 .
8.0
1.5 . .
1.0
8.0
..1.5-
0.228
0.152
0.028
' 0.019
.'0.160 .. ,
. 0.03
. ' DIRECT APPLICATION TO 6 INCHES OF WATER ; ,
forest tree management/forest pest management
forest tree management/forest pest management
forest trees (all or unspecified)
drainage systems . '
streams/rivers/channeled water
aerial, ground
aerial, ground
ground
aerial/
ground
ground
3.0
8.0
12.0
1.5
8
12
2.2021
.'5.8721
8.8081
'i.i'oi1
, 6.6061 .
8.8081
1. EEC's are based on one direct application to 6 inches of water. EEC - use rate in Ibs ae/A X 734 pbb
(a)
Freshwater Fish
Acute and chronic risk quotients are tabulated below for Triclopyr TEA. 'A 21-day and a
56-day EECs cannot be determined for the direct application to water scenarios.
81
-------
1,1
I
Ill II II
I" I
III
111 I III
III" ill
' 111
lilt:, itr* I ,,:|
illijl 'Kill ','> ;,;' ..... L:y
- 'fV !?:
'able 45: Acute and Chronic RQs for Freshwater Fish with Triclopyr TEA
i' i i , i nil i i i 11 I ^ i ., , i , , *j
?ite,, . , ,
a "
pastures, rangeland, non-
agricultural rights-of ways,
feneerows, hedgerows,
nonagricultural uncultivated
areas/soils
non-agricultural rights-of-way,
nonagricultural uncultivated
areas/soils
pastures, rangeland
ornamental lawns and turf
pastures, rangeland
Appfieaton
kfifhbd
ground
aerial
"Application
Rate, in
, tbsae/A
12.12
9.0
3.158
1.5
6.0
PsakEEC
fpptaae)
0.364
0.270
0.095
0.045
0.185
Acute
S.Q
<0.05
<0.05
<0.05
<0.05
<0.05
56-day
EEC
($pป ae)'
0.233
0.173 .
0.061
0.029
0.119
Chronic
RO,
<1
<1
<1
<1
<1
DIRECT APPLICATION TO 6 INCHES OF WATER
forest
drainage systems
rice
aerial
ground
ground
ground and
aerial
4.0
12.0
9.0
0.375
2.936
8.808
6.606
0.275
<0.05
<0.05
<0.05
<0.05
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
IRIi iiH !:,<'
W Bit1:".! "'"'I ''
Note: _ ' ' ~'m [ ' [ "m ' [ '_ ' [ \ : ' . \ . , .^ ... ' .,.
Calculations based on fathead minnowLC50 = 279 ppm ai and MATC = 130 ppm ai? equivalent to 199 ppm ae and 93ppm ae,
respectively.
Factor for conversion ot'aito ae is 0.7125, based upon the ratio of percentages of active ingredient to acid equivalents as specified on
product labels . ' "'
lip ;i Jill i "iiii'i,
fell!/'1,,', :ip.
I'l: ' i,|
31 '1:
'.(.i, in. - i
'Ji|ii* fiijiv"
;,lii,l|!!'":,: "i;
"'""I
Acute
The results indicate that acute high risk, restricted use, and endangered species levels of
| "I Jinn .,;v ., fi , , in :.*. ซ ,,," , , ,, ' , , , p, ,,f: ......
concern are not exceeded for freshwater fish at registered maximum application rates of Triclopyr
TEA.
ll i I ' ' ' . ' '
Chronic
''. ''I Jli' i ' ' I *i;.'.<. " ., . ;,
i Based on the MATC from the fathead minnow early life-stage (130 ppm (mg/L)) and the
, ,i Ml Illllll I I I II I T|| J & \. rr , L|\ o //
56-day average GENEEC, no chronic risk levels of concern for freshwater fish are exceeded at
kny of these use application rates and use patterns.
82
-------
Acute risk quotients are tabulated below for Triclopyr BEE.
Table 46: Acute Freshwater Fish RQs for Triclopyr BEE
Site- ' ' ' ,
agricultural/farm structures/buildings and
equipment fencerows/hedgerows, non-
agricultural rights-of-way, non-
agriculture uncultivated areas/soils
pastures, -rangeland
pastures, rangeland, industrial areas
(outdoor), non-agricultural rights-of-
, ways/fericerows/hedgerows, non-
agriculture uncultivated areas/soils
ornamental lawns and turf
non-agricultural rights-of-
ways/fencerows/liedgerows"
pastures, rangeland, industrial areas -
(outdoor), non-agricultural rights-of-
ways/fencerows/hedgerows, non-
agriculture uncultivated areas/soils
Application
Method' ,
ground
aerial
aerial
Application
Rate
jbs ae/A'
12.0
8.0
.; 1.5
1.0
8.0
' -1-5
PeakEEC
(^pi& ae)
0.228
0.152
0.028
.0.019'-
0.160
0.03
Acute RQ -
0.91
0.61
0.11
0.08
0.64
0.1'
DIRECT APPLICATION TO 6 INCHES OF WATER
forest tree management/forest pest
management
forest tree management/forest pest
management
forest trees (all or unspecified)
drainage systems
streams/rivers/channeled water
' aerial, ground
aerial, ground
ground
aerial
ground
ground
3.0 .. '
8.0
12.0
1.5
' 8
12
' 2.2021
5.8721
; 8.8081
"l.lOl1
6.6061
8.8081
8.81
23.49
35.23
4.40
26.42
'35.23
1. EECs are based on one direct application to 6 inches of water. EEC = use rate in Ibs ae/AX 734 pbb
Notes: ' . : , ' . "''.''
Calculations based on L. macrochirus LC50 of 0,36 ppm ai, equivalent to 0.25 ppm'ae.
Factor for conversion of ai to ae is 0.7192, based upon the ratio of percentages of active ingredient to acid equivalents as
specified on product labels. . - " ' . .
83 ,
-------
''..<*
, 'ill
Acute ' ' ' '
The results indicate the acute high risk level of concern is exceeded for freshwater fish at
the ma^mum|application rates for all the forest and direct application to water uses of Triclopyr
BEE. Additionally, the 8 Ibs ae/A and 12 ae/A use rates for ground application, and the 8.0 Ibs
ae/A use rate for aerial application exceed the LOG for acute high risk.
The level of concern for risk that may be mitigated through restricted use was exceeded by
the 1.5 Ibs ae/A ground application rate, and the 1.5 Ibs ae/A aerial application rate.
The level of concern for risk to endangered species was exceeded by the 1.0 Ibs ae/A
ground application rate.
Chronic
Although there is a calculated MATC available for the BEE for rainbow trout early life-
stage (6.0388 ppm), the nature of the study design was that the organisms were continuously
exposed to BEE at a constant concentration in a flow-thru system. Because BEE will not persist
as such in the environment following a single application (see GENEEC discussion), the toxicity
level found in this study does not reflect the probable effect of BEE on organisms in the
environment. Chronic effects may be unlikely from a single application of triclopyr BEE.
However, it is possible that the triclopyr degradate, TCP, may have a chronic adverse impact on
fish species because laboratory and field data indicate that the TCP may be persistent in aqueous
environments at concetrations greater than 1% of the LC so.
.' i JH..I ," V. ' ' '' SB::-,' ,' /,; ' :>" :;ฃ(. ' "' .' ;V\3v' .'...'' ';:'ป, V./ป'-.V- ;:.. '"i:'1C.1 I , '. . ' /
(b). Freshwater Invertebrates
The acute and chronic risk quotients for triclopyr TEA are tabulated below.
84
-------
Table 47: Acute and Chronic Freshwater Invertebrate RQs for Triclopyr TEA
, , ,,'',Sjte ^ '
pastures, rangeland, non-
agricultural rights-oif ways,
fencerows, hedgerows,
nonagricultural uncultivated
. ' areas/soils
, non-agricultural rights-of-way,
nonagricuitural uncultivated
areas/soils
pastures, rangeland
ornamental lawns and turf
pastures, rangeland
Application.
Meitod
ground
aerial
Apj5Mca.ftan
Kstem
$5$ ae/A
12,12
. ..'9.0
3.158
1.5 . :
6.0''
?eak
EEC-
..(ppjUaa)
0.364
. 0.270
0.095
0.045
0.185
21-day
EEC ,
(ppm ae)
0.305
0.277 ,
0.080
0.0375. '
0.156
Acute
*&
0.05
. 0.05
0.05 '
0.05
0.05
Chronic.
. &Q ";
1.00
1.00
. 1.00
LOO
1,00
' DIRECT APPLICATION TO 6 INCHES OF WATER
forest
drainage systems
rice
aerial
ground
ground
/ground and
aerial
'4.0
12.0
9.0
0.375
2.936
8.808
6.606
0.275 .
N/A.
N/A
N/A
N/A'
0.05
0.05
0.05:
0.05
N/A
N/A
.- N/A
N/A
'Notes: . . . . . .
Calculations based on Daphnia magna LC50 = 775 ppm ai and MATC = 110 ppm ai, equivalent to 357 ppm ae and 79
ppm ae, respectively. , '
Factor for conversion of ai to ae is 0.7125, based upon the ratio of percentages of active ingredient to acid equivalents as
specified on product labels. . .;... '
Acute ' ' . . ''
The results indicate that acute high risk, restricted use, and endangered species 1 evels of
concern are not exceeded for freshwater invertebrate at registered maximum application rates of
Triclopyr TEA. . '..-.-'.'
Chronic -
Based on the MATC from the Daphnia magna aquatic mvertebrate-life-cycle study (1 TO
ppm) and the 21-day average GENEEC, no chronic risk levels of concern for freshwater
invertebrates are exceeded at any of these application rates and use patterns. ,
85
-------
M:, ซi" 1
'
''i1.
The acute risk quotients for triclopyr BEE are tabulated below:
ii ii 11 n i i i n i i
i linn i i
Table 48: Acute Freshwater Invertebrate RQs for TricJopyr BEE
II *a| &K*"''.,, , *
Site ^ ,
i ' f i - ^ ,""">
, '!,-,,<
I' ' 1 V 1 <: N ~ '
agricuIturaWann structures/buildings
and equipment, fencerows/hedgerows,
non-agricultural rights-of-way, non-
apiculture uncultivated areas/soils
pastures, rangeland
pastures, rangeland, industrial areas
(outdoor), non-agricultural rights-of-
way/fenc^rows/hedgerows, non-
agriculture uncultivated areas/soils
ornamental lawns and turf
non-agricultural rights-of-
way/fcncerows/hedgerows
pastures, rangeland, industrial areas
(outdoor), non-agricultural rights-of-
way/fencerows/hedgerows, non-
agriculture uncultivated areas/soils
AppJicalon
Me&ed
* '
ground
aerial
aerial
ApptJeaiMm
Bate
' lisse/A
12.0
8.0
' 1.5
1.0
8.0
1.5
Peek EEC
(ppra ae)
0.228
0.152
0.028
. 0.019
0.160
0.03
AcUfcj RQ
0.03
0.02
0.00
0.00
0.02
0.00
DIRECT APPLICATION TO 6 INCHES OF WATER
forest tree management/forest pest
management
forest tree management/forest pest
management
forest trees (all or unspecified)
drainage systems
streams/rivers/channeled water
aerial, ground
aerial, ground
ground
aerial
ground
ground
3.0
8.0'
12.0 .
1.5
8,0
12.0
2.202 '
5.872
8.808
1.101
6.606
8.808
0.26
0.68
1.02
0.13
0.77
1.02
Notes: ,
Calculations arc based pnJDaphnia magnet LCSO= 12.0 ppm ai; equivalent to 8.6 ppm ae.
EECs are based on one direct application to 6 inches of water. EEC = use rate in Ibs as/A X 734 pbb.
Factor for conversion of ai to ae is 0.7192, based upon the ratio of percentages of active ingredient to acid equivalents as specified on
product labels,
Acute
'~-^*-^ ,p . ,,, i||Jf| ., ,.. ,, . | .,. lf ^ , , . . ,,,_ , , ;l| | , .,,,..... ... .,, , ;,;,;,! . | ,, , , , . " '.
The results indicate that the high acute risk level of concern is exceeded for freshwater
invertebrates at the application rates of 8.0 Ibs ae/A and 12 Ibs ae/A uses rate for forest trees (all'
86
-------
or unspecified), and the 8 Ibs ae/A use rate for drainage systems and the 12 Ibs ae/A use rate for .
streams/rivers/channeled water uses.of Triclopyr BEE. ' -. , ' .
The level of concern for risk that may be mitigated through restricted use was exceeded at
the 1.5 Ibs ae/A use rate for forestry use and the 1.5 Ibs ae/A use rate on drainage systems.
Chronic ' . .
A chronic risk assessment for triclopyr BEE was not done because BEE will not persist as
such in the environment following a single application (see GENEEC discussion).
(c). Estuarine and Marine Animals
Triclopyr TEA is similar in acute and chronic toxicity to freshwater and estuarine/marine
animals. Therefore, the acute and chronic risk is presumed to be similar to that for freshwater
animals; i.e., the acute high risk, chronic risk, restricted use, and endangered species levels of
concern,are not exceeded for estuarine/marine invertebrates and fish at registered maximum
application rates of Triclopyr TEA. ,
Triclopyr BEE is similar in acute toxicity to freshwater and estuarine/marine animals.
Therefore, the acute .risk to estuarine/marine organisms from triclopyr BEE is presumed to be
similar to that for freshwater animals; i.e., the high acute risk level of concern is exceeded for
freshwater fish at the maximum application rates for all the forest and direct application to water
uses of Triciopyr BEE. . ;
A chronic estuarine/marine risk assessment for triclopyr BEE was not done because BEE
will not persist as such in the environment following a single application (see GENEEC.
discussion)." . .
(3). Exposure and Risk to Nontarget Plants
Terrestrial arid Semi-aquatic
a). Terrestrial and Semi-aquatic
Terrestrial and semi-aquatic plants may be exposed to pesticides from runoff, spray .drift
or volatilization. Semi-aquatic plants are those that inhabit low-lying wet areas that may be dry at
certain times of the year. The Agency's runoff scenario is: ',''.
' - /"
based on a pesticide's water solubility and the amount of pesticide present on the soil
, surface and its top one inch,
87
-------
I "I I 'I I ., ::.:! i,.";"!1 * - '';- , V V \I:;<;v i 'V ;:>".., .! 11 ''. ' .,'., :... /![,ป;;' . , ,f .':.. .. ' - , , : ,
characterized as " sheet runoff1 (one treated acre to an adj acent acre) for terrestri al
plants,
characterized as "chamejize4runoffl,i(10 treated acres to a distant low-lying acre) for
plants inhabiting semi-aquatic area, and
based on % runoff values of 1, 2, and 5 for water solubility of <10 ppm, 10-1.00 ppm,
ahd > 100 ppm, respectively.
Spray drift exposure from ground application is assumed to be 1% of the application rate.
Spray drift from aerial applications is assumed to be 5% of the application rate. EECs are
calculated for unincorporated ground and aerial applications. Estimated environmental
concentrations for terrestrial plants are tabulated below.
Table 49: 'EJECs'for Terrestrial and Semi-AquaticPlants for Triclopyr TEA with 5%
Runoff
I'lJIl nil i iiiitin i MHป M *ซi. ,t
Site
1 i1 s i in - ^ * ',
<
"'>:'
1 1 S f'l'vป
pasnuies, rangeland,
fencerow/hedgerows, non-
agricultural rights-of-way, non-
agriculture uncultivated
areas/soils
non-agricultural rights-of-way,
non-agriculture uncultivated
areas/soils
pastures, rangeland
ornamental lawns and turf
pastures, rangeland
forestry
drainage systems
nee
Method.
*
ground
aerial
aerial
ground
ground
aerial
ground
Appl,
Rate
0b
aefA)
9.0
3.158
1.5
6.0
4.00
12.0
9.0
0.375
0.375
Sheet
Usa-off
-------
Table SO: EECs for Terrestrial and Semi-Aquatic Plants for Triclopyr BEE with 1%
Runoff
,, ,
* ,, , Site
.
" ff ff
' r ' '/', '
agricultural/farm structures/ buildings
and equipment, fencerow/ hedgerows,
non-agricultural rights-of-way, non-
agriculture uncultivated areas/soils -
pastures, rangeiand
pastures, rangeiand, industrial areas
(outdoor), non-agricultural rights-of-
way/fencerows/hedgerows, non-
agricultural uncultivated areas/soils
ornamental lawns and turf
non-agricultural rights-of-ways,
fencertiws/hedgerows
pastures, rangeiand, industrial area&
(outdoor), non-agricultural rights-of-
ways, fencerow/ hedgerows, non-
agriculture uncultivated areas/soils
forest tree management/forest pest
management -
forest tree management/forest pest
management
forest trees (all or unspecified)
drainage systems
streams/rivers/channeled water
Me&od1
1
ground
aerial
aerial
ground
aerial
ground
ground
aerial
ground
ground
AppL,,
Rate
(it* as/A)
' .
12.0
8.0
1.5
1.0
8.0
1.5-
3.0
- 3.0
8.0
8.0
12.0
: 1.5
8.0
'12.0
, Sheet"
Raaซff
$& ae/A)
, ,
'
0.12
~-
0.08
0.02
0.01
0.05.
0.01
0.02
0.03 .
0.05,
0.08
0,12
,0.01
0.08
0.12
Clwtael
, kiia-off
(lb ae/A)
1.20
0.80
. 0.20
, 0.10
0.48
0.09
0.18
0.30
0.48
0.80
1.20
' 0.09 -
0.80
.- 1.20 ".
Dr-ift
(lb ae/A)
i
0.12
0.08
0.02
0,01
,0.40
0.08.
""
.0.15
0.03
0.40
.0.08
0.12
0.08
0.08
'0.12
Total
Loading
10
Adjacent
Area. $t>
-------
<:., MSI
Table 51: Acute RQs for Plants in Terrestrial and Semi-Aquatic Areas for Triclopyr
TEA
Jliilfil inn (iiii|iii|ii|ป( .I ii" 1
Sifc
,
in i i i j
1 t!" ''"I i
1 lil|i|lllllllllillllli|i||i||iylUIII\i fVhfft
pastures,
rangchnd,
fenccrow/hedge
rows, non-
agricultural
rights-of-way,
non-agriculture
uncultivated
ureas/soils
non-agricultural
rights-of-way,
ram-agriculture
uncultivated
areas, soils
pastures,
range-land
omumcnlal
lawns and turf
pastures,
rangeland
forestry
drainage
systems
drainage
systems
rice
rice
Apji
Method
1
ground
aerial
ground
aerial
ground
ApptRat^
JB '
! Ibsae/A
v
"
12.12
9.0
3.185
1.5
6.0
4.0
12.0
9.0
0.375
0.375
IMft
;
fotef
!"st"
sqtfa%
Area (13?
ae/A}
6.22
4.59
1.63
0.82
2.10
1.40
6.12 .
4.59
0.13
0.21
KQof
Adjwsat
Area.
3.10
2.30
0.80
0.40
2.00
1.30
3.00
2.30
0.10
0.10
5.Qoฃ
$%&&
Aspatfe-
Atea ,
26.20
19.30
6.90
3.40
8.80
5.90
25.80
19.30
0.50
0.90
feOof
Spray
Drift
to
tlant
22.20
16.70
5.60
3.70
55.60
37.00
22.20
16.70
3.70
1.00
Notes; ! \
Calculations are based on seedling emergence endpoint value for corn = 0.333 Ibs ai/A and a sunflower vegetative vigor endpoint
0.0076 Ibs ai/A, equivalent to 0.2373 Ibs ae/A and 0.0054 Ibs ae/A, respectively.
Factor for conversion of ai to ae is 0.7125 Ib ae/A, based upon the ratio of percentages of active ingredients to acid equivalents as
specified on product labels.
-------
Table 52: Acute RQs for Plants in Terrestrial and Semi-Aquatic Areas for
Triclopyr BEE
. * X f
S f
agricultural/farm
structures/buildings
and equipment,
fencerow/hedgerows,
non-agricultural rights-
of-way, non-'
agriculture
uncultivated areas/soils
pastures and rangeland
pastures, rangeland,
industrial areas
(outdoor), non- -
agricultural rights-of-
ways, fencerows,
hedgerows, non-.
agriculture
uncultivated areas/soils
ornamental lawns and
turf ' '
non-agricultural rights- ,
of-ways, fencerows
/hedgerows
pastures, rangeland,
industrial areas
(outdoor), non-
agricultural rights-of-
ways, fencerow,
hedgerows, non-
agriculture
uncultivated areas/soils
forest tree \
management/forest
pest management
forest tree.
management/forest
pest management
forest tree
management/forest
pest management
,
Appl
; Method
'
ground
aerial
ground
aerial
,
; Apf itostroa
I Rate-iaJi>5'
ae/A
! ' '-.
:
12,0
8.0
1.5
1.0
,8.0
1.5
3.0
3.0
8.0 . '
Pซft
$fo '
ae/A}^ _
f
Q.12
0.08
0.02
0.01
0.40
0.08 ,
0.15
0.03
0.40
Total
leading ft>
A4jacซtt
Area{it>
ae/A)
0.24 .
0.16
0.04
'.
0.02
0.45
0.09
0.17
'
0.06
0.45
s
t<5fel
l&a&'ng
'to Semi"
aqtiaffc
Ar*a(ib
ae/A)
1.32
0.88
0.22
0.11
0.88
0.17
"0.33
0.33 '
0.88'
i KQof %
Raneffts '
; Asf acent
; Area ,
: ^
5.40
3.60 .
0.90
0.40
10.10
2.00
3.80
1.30
10.10
RQof
Rusoff
toSeroi-
AqpsSfe
Area
29.50
19.70
4.90
2.50
19.60
3.80
7.40 .
7.40
19.60
S.Q<3ts
$pray
Drift
to
Slant
18.80
12.50
3.10 .
1.60
62.50
12.5,0
23.40
4.70 "
62.50'
91
-------
((I
'"$& , ; ':
ipllni lililiili il INI II ii ii n '^p IK ^
ii 'in'ill ill M i' "ft",
1 '' , r
A ^
forest tree
management/forest
pest management
forest trees - all or
specified
drainage systems
drainage systems
streama'rivers/channel
ed water
Appl
Method
v
''
*
ground
ground
aerial
ground
ground
Application
Kate, la Ibs
Stt'iA
..
, , \
8.0
12.0
1.5
8.0
12.0
iQrfll
i[ilj
' ae/A) ^
"*
0.08
0.12
0.08
0.08
0.12
Tata}'
lUmding to
Adjacent
Ai4a(ib-
ae/A)
'
0.16
0.08
0.09
0.16
0.24
Total
LoaiSng;,
to-Sซnl-
aqaatio
Area
ae/A)
0.88
1.32
0.17
0.88
1.32
SQOf
Ruaoffto
Adjaeest
Area
3.60
5.40
2.00
3.60
5.40
SQof
Eiraott
tp Setai-
Aquatto
Arei
19.60
29.50
3.80
19.60
29.50
RQctf
Spray
"Drift
to
Pfant .
12.50
18.80
12.50
12.50
18.80
'Notes:
Calculations are based on seedling emergence value for alfalfa of 0.0622 Ibs ai/A and a sunflower vegetative vigor endpoint value of
0.0089 Ibs ai/A, equivalent to 0.0447 Ibs ae/A and 0.0064 Ibs ae/A, respectively.
Factor for conversion of ai to ae is 0.7192 Ib ae/A, based upon the ratio of percentages of active ingredients to acid equivalents as
specified on product labels.
Terrestrial Plant Assessment
Triclopvr TEA
Ground application results indicate that acute risk and endangered plant .species' levels of
concern from riinqlf are ejcceeded |pr non-target terrestrial plants at rates of application equal to
or above 9fO Jbae^| inhabiting adjacent acreage and 1.5 Ib ae/A or higher inhabiting semi-aquatic
areas. The 1% drift from ground application exceeds LOCs to non-target terrestrial plants at
application rates of 1.5 Ib ae/A or higher and to endangered plant species at rates of 0.315 Ib ae/A
or higher.
HIM . . ' , ' !<|iiซi,i!|i .' ' '' iป'i . '.J i, "" , Tปii" ",, '" , . ', " '' i'1 ,'.,' '! ,, " I'
I" Aerial application results show LOCs for non-target plants and endangered plant species
inhabiting adjacent areas and semi-aquatic areas being exceeded at application rates of 4.0 Ib ae/A
or Mgher. Risk quotients for 5% spray drift from aerial application exceeds the LOG for non-
target and endangered species of plants at application rates of 6.315 Ib ae/A or higher.
Triclopyr BEE
; I Ground application results indicate that non-target terrestrial plant acute risk levels of
concern from runoff are exceeded at rates of application equal to or above 3.0 Ib ae/A inhabiting
adjacent acreage and 1.0 Ib ae/A or higher inhabiting semi-aquatic areas. Risk quotients using 1%
drift from ground application to non-target terrestrial plants exceed LOCs at application rates of
92
-------
1.0 Ib ae/A or higher. Endangered plant species inhabiting adjacent areas and semi-aquatic areas
may be affected at all application rates of triclopyr BEE. .
Aerial application results show LOCs from runoff being exceeded at application rates of
1.5 Ib ae/A or higher to non-target plants inhabiting adjacent'areas and semi-aquatic areas. Level
of concern to non-target plants was exceeded when 5% that was applied drifted. Endangered
plant species may be affected from aerial application of triclopyr BEE.
(b). Aquatic ,
Exposure to nontarget aquatic plants may occur through runoff or spray drift from
adjacent treated sites or directly from, such uses as aquatic weed or mosquito larvae control. An
aquatic plant risk assessment is usually made for aquatic vascular, plants from the surrogate .
duckweed Letnna gibba. Non-vascular aquatic plant risk assessments are performed using either
algae or a diatom, whichever is the most sensitive species. Runoff and drift exposure is computed
from GENEEC. For aerial application to forestry, rice, drainage systems, and rights-of-way,
direct application to six inches of water is assumed. The risk.quotient is determined by dividing
the pesticide's initial concentration in water by the plant EC50 value.
Acute risk quotients for vascular and non-vascular plants are tabulated below.
Table 53: Acute RQs for Aquatic Plants for Triclopyr TEA
Site aปtJ Rate of ,
Application $bWA} -
pastures, rangeland,
fencerow/hedgerows,
non-agrieultunil rights-
of-way, non-agriculture
uncultivated areas/soils
(12. 12 Ib ae/A)
non-agricultural rights-
of-way, non-agriculture
uncultivated areas/soils
(9.0 Ib ae/A)
pastures, rangeland
(3. 158 Ib ae/A)
Ornamental Lawns and
Turf (1.5 lbae/Ay
Appl
M-e&orf
Ground
Ground
>
Ground
Ground
TซM Species
duckweed
algae or -
diatom
duckweed
algae or
diatom .
duckweed
algae or
diatom
duckweed
EC,/;;;
(jpaae)
6:27
4.20
. 6.27,
4.20
6.27
' 4.20
6.27
EC^-or
NOEC&pm"
; ,ซ*)'
2.49
n/a
2.49
n/a
"' 2.49
n/a
: 2.49
, EEC '
(ppffi
ae), ,..
0.364
0.364
0.270
0.270
0.095 ,
0.095
0.045
A
-------
Table 53: Acute RQs for Aquatic Plants for Triclopyr TEA
, -^i^ittantf&tteq^ ^
Application (Sib ae/A}
|f Lli''l''lli iisiivปp^hiinn i JWl! ^
I '" ป*!
Pastures and Rangeland
(6.0 Ib ae/A)
Appi-
Method
ss " %-
Aerial
Test Species
algae or
diatom
duckweed
algae or
diatom
BCซ
(ppra ae)
4.20
6.27
4.20 .
EC^r'
NOEC {ppm
ae)
n/a
2.49
n/a
me -
(ppm
ae)
0.045
0.185
0.185
Acute
&ง\
<1.0
<1.0
<1.0
Bftdaag
,JR,Q3
n/a
<1.0
n/a
DIRECT APPLICATION TO 6 INCHES OF WATER
Forestry (4.0 Ib ae/A)
drainage systems (12.0
Ib ae/A)
drainage systems (9.0 Ib
ae/A)
Rice (0.375 Ib ae/A)
Aerial
ground
Ground
Ground
and
aerial
duckweed
algae or
diatom
duckweed
algae or
diatom
duckweed
algae or
diatom
duckweed
algae or
diatom
6.27
4.20
6.27
4.20
6.27
4.20
6.27
4.20
2.49
' . n/a
2.49
n/a
2.49
n/a
.2.49
n/a
2.936
2.936
8.808
8.808
6.606
6.606
0.275
0.275
<1.0
<1.0
1.4
2.1
<1.0
1.6
<1.0
<1.0
1:2
n/a
3.5
n/a
2.7
n/a
<1.0
n/a
Notes;
! Factor for conversion of ai to ae is 0.7125 Ib ae/A, based upon the ratio of percentages of active ingredients to acid
equivalents as specified on product labels.Th.e- Endangered Species RQ is calculated from the EEC/EC05 or NOEC
^'aluCi .Cdculstipns.arebased .upon a duckweed (Lemna gibba) EC50 of 8.8 ppm ai and a non vascular plant (Anabaena
jlos^quae) ECJO of 5.9 ppm ai.(equivalent to 6.27 ppm ae and 4.20 ppm ae, respectively)1
lliiilil ill ' i :!'",i>i!i
E .Itiit'''
IK'
r
Hi
I;J The Endangered Species RQ is calculated from the EEC/EC05 or the NOEC value.
* There are no listed endangered species of algae or diatoms.
'"'?''
i!'
',,: "In"!! ,. 'I1 f
../i if-: ':',
ii'ili ill-"
"94
-------
Table 54; Acute RQs for Aquatic Plants for Triciopyr BEE)1
Site and Rate Gf
Appl;dfa$WAji
" ""
-------
iiji^ii:*:}. ir': i*!"*'
WOT f? :;'. pt.
itli Hi|||< '' iii,;;!!/!]! j;,; jii''l spill,,;; ;,
Table 54: Acute RQs for Aquatic Plants for Triciopyr BEE)1
ilinl illlan1 1 1 in 'i (lip "i s" ir j 1t
Site ana Rate of
Appl (B> ae/A)
; ji!1 "tv ' *
pa^ures,
rangeland,
industrial areas
(outdoor), non-
agricultural rights-
of-ways, fencerow,
hedgซa-ows, non-
agriculture
uncultivated
areas/soils (1.5 Ib
ae/A)
Aj>i>i;
Method
Aerial
, ,^est
Species
duckweed
algae or
diatom
>BCป
1 {ppmae)
0.63
0.07
BO***
' H0Bฃ '
i {jpnae)
<0.12
n/a '
; BSC
-------
'Factor for conversion of ai to ae is 0.7192 Ib ae/A, based upon the ratio of percentages of active ingredients to acid
equivalents as specified on product labels. Calculations are based upon a duckweed rLemna gibba) ECJO of 0.88'ppm ai
and a non vascular plant (Nyviculapelliculosd) EC50 of 0.10 ppm ai (equivalent to .0.63;ppm ae and 0.07 ppm ae,-
respectively . ',"'.''''
The acute RQ is calculated from the EEC/EC50. . .
3 The Endangered Species RQ is calculated from theBEC/EC05 or NOEC value. ; ' '
4 There are no listed endangered species of algae or diatoms. .
Aquatic Plant Assessment
Triclopyr TEA - Aquatic Vascular Plants
1 , i ' . . .
The results indicate that for Triclopyr TEA, levels of concern for acute risk are exceeded
for vascular aquatic plants from the direct application to water at 12.0 Ib ae/A. The LOG for
endangered species of aquatic plants is exceeded at 9.0 Ib ae/A or higher in a direct application to
water scenario. ' - ' . .\
Triclopyr TEA - Algae and Diatoms .
The results indicate that for Triclopyr TEA, levels' of concern for acute risk to algae.and
diatoms are exceeded at application rates of 9.0 Ib ae/A or higher from direct application to water
scenario. , ' ' ' .
Triclopyr BEE - Aquatic Vascular Plants
Acute risk and endangered species levels of concern are exceeded for aquatic vascular
plants at the rates of 8.0 Ib ae/A or higher and at 1.5 Ib ae/A or higher when used in a direct
application to water scenario.
Triclopyr BEE - Algae and Diatoms , ' ' ;
. Results indicate that levels of concern for acute risk are exceeded at the rates of 8.0 Ib
ae/A or higher and at 1.5 Ib ae/A or higher when applied directly into water.
(4). Endangered Species
Endangered species LOCs are exceeded for triclopyr TEA for birds, mammals and for
aquatic and terrestrial plants. Endangered species LOCs are exceeded for triclopyr BEE for birds,
mammals, fish, aquatic invertebrates, estuarine species and aquatic and terrestrial plants.
The Endangered Species Protection Program is expected to become final in the future.
Limitations beyond those specified in this RED in the use of triclopyr may be required to protect
endangered and threatened species, but these limitations have not been defined and may be
.. ' . ' ~ . ' .97 ... ' :
-------
JIIIDI! 3:,1[
. IIEK1 lill
, , llllill! 'i,,,,'1!,."!''"!
ปy' IBIK ,i,V'
.j'1 ".;:;,ii",:|i!;::,:1i;iii!, at in*W'M.'U.K! 'i?w
I I1: I: .ฃ I"'," ! 'nl!!!!!
, ,'"*,'"'!'' ::: i i,i ,r" '!,,' .. I1!'
11 .... piili'BI :r ,i'"!' . i: -:, * /-ill'1 , II, fi',,,1 'I'i ": , i,:"!!,',;!,,; It I1 ' '' ,: ,'" M" ;ป ,|l, ,1.1: ' Hi ,,, ' , , ,, ,":, ,,', I",,1 ' , "I1!,; ,5',: :, I !, r
fonnulafion and area specific. EPA anticipates that a consultation with the Fish and Wildlife
Service will be conducted in accordance with the-species-based priority approach described in the
Pcpgram. After completion of consultation,, registrants will be informed if any required label
modifications are necessary. Such modifications would most likely consist of the generic label
sta|emen,t referring pesticide users to use limitations contained in county Bulletins.
b. Environmental Risk Characterization
Triclopyr TEA rapidly dissociates in water to the triclopyr acid/anion and triethanolamine.
.Tijclppyr_BEE rapjdi^hydjplyjzes^m the enyironment to the triclopyr acid/anion and
butoxyethanoL Both tiiethanojarnine andJ3utoxyethanoi are rapidly dissipated by microbial
degradation. Triclopyr acid is a weak acid which will dissociate completely to the triclopyr anion
atpHs > 5 (dissociation constant pKa 2.93). Therefore, triclopyr anion will be the moiety present
in the environment when products containing either triclopyr BEE or triclopyr TEA are used.
Triclopyr acid/anion is moderately persistent and is mobile. The predominant degradation
pathway for triclopyr hi water is photodegradation. The predominant degradation pathway in soil
.is microbial degradation to the major degradate 3,5,6-trichloro-2-pyridinol (TCP), which is both
persistent and mobile.
Triclopyr is moderately persistent, with persistence increasing as it reaches deeper soil
levels, where anaerobic conditions predominate; it is also very mobile. However, because
trigjppyr is not expected to reach high concentrations in ground water, the Agency concludes that
it isnpt a gQngem in drinking water that is derived from ground water. Triclopyr and TCP do not
adsorb to soil and sediment particles, and may be transported in surface runoff waters. Although,
trielopyr is not predicted to persist in surface waters,information from two aquatic field
dissipation studies conducted on rice indicates that following application of triclopyr, TCP can
persist in flood waters. Triclopyr is not currently regulated under the Safe Drinking Water Act
(SDWA);_"2ierefor^a Maximum Contaminant Level (MCL) is not established. Public water
supply systems are not required to sample and analyze for triclopyr.
Groundwater Conclusi ons
The Agency concludes that triclopyr BEE and triclppyr TEA are mobile but not
particularly persistent. The multiple potential degradation pathways (hydrolysis,
photodegradation, and aerobic soil metabolism) and its rapid degradation significantly decrease
the potential for triclopyr to reach deeper soil horizons. The principle degradate, TCP, is
relatively mobile and persistent and has the potential to contaminate ground water. If triclopyr or
its degradates reach deeper soil levels where anaerobic conditions exist, persistence will increase
and it is more likely to reach ground water. If the compounds did reach ground water, they are
not Ukeiy to reach or exceed OPP's estimate of the HA of 350 ppb for drinking water. The
degradate TCP is probably the most mobile of the compounds and the most likely to reach ground
water, but it is not expected to reach high concentrations.
98
-------
Surface Water Conclusions
. Information from acceptable and supplemental environmental fate studies indicates
triclopyr is.non-persistent in surface waters (aquatic field dissipation half-lives of 0.5 and 3.5 days
for surface and aerial applications, respectively for Lake Seminole, Georgia). However,
. information from two aquatic field dissipation studies conducted on rice indicates that following
application of triclopyr, TCP can persist in flood waters. . .
Ecological Toxicity - Characterizing risk:
Birds
Acute Risk . .
Triclopyr TEA exceeds the LOCs for high acute risk at 12.12 Ib ae/A for birds feeding on
short grass. The LOG for restricted use is exceeded at the use rates > 6.0 Ibs ae/A for birds
feeding on short grasses and the use rate of > 9.0 Ibs ae/A for birds feeding on broadleaf plants
and small insects.. The LOG for endangered bird species is exceeded at use rates ;> 3.185 Ibs ae/A
for birds feeding on short grasses and at use rates > 6.0 Ibs ae/A for bird feeding on long grasses,
broadleaf plants, and small insects. . . ' ' _
Triclopyr BEE exceeds the LOG for high acute risk for birds feeding on short grasses at
the 12.0 Ibs ae/A use rate. The LOG for restricted use is exceeded at use rates >8.0 Ibs ae/A on
short grasses, long grasses, and broadleaf plants and small insects. ,
-. The granular formulation of triclopyr TEA (0.54 Ib. a.i./A) does not exceed any level of
concern. .
Chronic risk - , .-",-. . '
Triclopyr TEA exceeds the chronic risk LOG for fruit and pod food items at the 9.0 and
12.12 Ibs ae/A use rates. For the remaining food items (short grasses, long grasses, broadleaf
plants and small insects), triclopyr TEA exceeds the LOG for chronic risk at all use rates.
Summary Of Avian Risk ' ' .
The currently-labeled use rate for triclopyr TEA granular formulation (0.54 Ibs ae/A) is
not likely to pose a risk to birds.
Acute Risk . , "
99
-------
'Ill "111 iiiVII'lilill!"!:111'!"1 li'l'l i;"illli ."'I11!' " IIIIM '"
I.H'i'.L'ftiL'j'.Ssi-;'"!''' "&~:\
sPec!es which feed on short grasses are the most suspectable to possible acute impact
from the use of triclopyr TEA and BEE at 12.0 Ib ae/A However, since the Kenaga and Hoerger
nomograph values are based on zero hour exposure and do not consider any degradative
processes, available residues of triclopyr TEA and BEE may be lower than predicted by these -
values. The foliar persistence and duration of palatability of vegetation treated with triclopyr
TEA and BEE is uncertain. '.,-,.
ill i i| I '. :' jii , ... ' /' "' '.;".. ':'; :!.;, li;I:*|- ' I .".'":, '; " , '. .'.. ' ; , 1'.J";1
Chronic Risk
1 ..... '"" '' , ..... ' ..... ...... 'Wป' ' ' I. ' I' ' ' , '., I.N " ' " Til
There is potential for triclopyr acid to cause reproductive impairment (i.e. chronic effect)
to birds when concentrations greater than 100 ppm are reached. Use of maximum residue levels
in the avian risk assessment is a first level screen, because it accounts for any uncertainty of
laboratory ecotoxicity data, lack of residue fate data on foliage, behavior of bird species in the
field, and environmental conditions. This conservative assessment" provides safety factors for bird
species not accurately represented by the test surrogate species. Although the persistence of
triclopyr acidVanion on avian food items is unknown, it is possible that environmental
concentrations will remain high enough for sufficient duration to produce chronic effect(s).
Terrestrial Mammals
The Agency determined that all three forms of triclopyr are bioequivalent for testing
purposes. (Toxicology Endpoint Selection Document 24 June 1 996). Therefore, the same rat
LD50 was used to calculate risk quotients (RQ's) for both the BEE and TEA forms of triclopyr in
the mammal risk, assessment. ^ PI( ....... ,. '^ , i(j|. . ; , _ , .. ...... ...... , IBII , , _
HI ',. :'.!';*_ V '.',.,'ซ,',:'"' ...... " '''-"I ,: ' &" '; : i; / "' ',;. ' ,.( !-'"'"':" ,{.;'.; ' : "V; .'.''* ;..'' ^ *;.. ' ''I, ;' . ', ' " -1'1 \' ;. "" '''. ..;,'''' '
Acute risk to mammals
1 ," ' V ' , IN !, ]| : ''' ' "AIM , ' i !| ''''"" 'i ป'' , ,; a v,,", ' n , ''' "' |, , ,; ;!;"/, ;', , ' ป ',, ' ': , y'',ป .|,'ii,, ' ", " ; ''i'1 " [, ' , ,,i " ' , ., ,,' ' , ! ' , ,; ' ,;
Triclopyr TEA and triclopyr BEE do not exceed any,LOC for fruits, pods, and large
insects. Triclopyr TEA and triclopyr BEE do not exceed the acute high risk LOG.
Triclopyr TEA and triclopyr BEE exceed the restricted use LOG criteria for mammals
feeding on short grasses at use rates ^6.0 Ibs ae/A, and on forage and small insects at use rates of
* 12.12 Ibsae/A.
II I I III III " JIN i i ii i i i i " ' '
Triclopyr TEA and triclopyr BEE exceed the endangered species LOG criteria for
mammals feeding on short grasses at the use rate > 3.185 Ibs ae/A and for mammals feeding on
forage and small rnsects at use rates ^6.0 Ibs ae/A.
-Chmnic risk to mammals
._...
s from the 2-generatipn rat reproduction study indicate that triclopyr TEA and
fl! ..... ' !';'"*' triclopyr BEE exceed me chronic risk LOG for mammalian species at some rates
'' ' '
100
-------
Triclopyr TEA and BEE exceed the LOCs for chronic risk to mammals feeding on short
grasses at use rates > 1.5 Ibs ae/A and on forage or small insects at u'se rates 23.185 Ibs ae/A.
Neither triclopyr TEA nor triclopyr BEE exceed the chronic LOG for mammals feeding on
fruits, pods, and large insects. /
Summary 'Of Mammali an Ri sk .
Mammal species that feed on short grasses are the most susceptible to possible acute
impact from the use of triclopyr TEA and BEE above 3.0 Ib ae/A; for chronic effects, the rate is
at or above 1.5 Ib ae/A. However, since the Kenaga and Hoerger nomograph values are based
on zero hour exposure and do not consider any degradative processes, residues of triclopyr TEA
and BEE may be lower than predicted by these values. The foliar persistence and duration of
palatability of vegetation treated with triclopyr TEA and BEE is uncertain.
.The acute and chronic risk assessments for mammals are based solely on toxicity data
using the laboratory rat. Because other types of mammals consume a greater proportion of their
body weight per day, the resultant ingestion of greater quantities of triclopyr may result in greater ,
risk to these mammals.,
/ . , -
Although the persistence of triclopyr acid/anion on avian food items is unknown, it is
possible that environmental concentrations will remain high enough for sufficient duration to
produce chronic effect(s).
Insects
Currently, the Agency has no procedure for assessing risk to nontarget insects. However,
because all forms of triclopyr are practically non-toxic to bees, it is not expected that insects will
be adversely affected by the use of triclopyr.
Non-Target Aquatic Animals
Triclopyr TEA
Triclopyr TEA exposure does not exceed any level of concern for acute or chronic risk to
aquatic (freshwater and estuarine/marine) invertebrates and fish.
, . TriclopvrBEE -
Overall the triclopyr BEE formulation is more toxic to aquatic (freshwater and
estuarine/marine) invertebrates and fish, and represents a greater potential acute risk than the
TEA formulation. Based on the similarity of-acute toxicity endpoints, risk to estuarine/marine
aquatic species is assumed to be comparable to that of freshwater species.
10L . ,
-------
,i, 1.1
'!
jiiiHe'Sji 'i i', i1, '
Exposures for non-agricultural uses (e.g. forestry, drainage, etc), based on direct
application to water, result in high acute risk to fish at use rates greater than 1.5 Ibs ae/A and for
invertebrates at use rates greater than 8.0 Ibs ae/A. In addition, triclppyr BEE may acutely affect
endangered fish and mollusks at all use rates, and may affect other aquatic invertebrate species at
use rates :>1.S Ibs ae/a. "^ " ' :'" | | :
::::: For agricultural use sites, exposures based on the 8.0 Ibs ae/A aerial application may pose
acute high risk. Additionally, exposures based on the 1.5 Ibs ae/A aerial application may acutely
affect endangered fish and mollusks at all use rates and is also a.candidate for restricted,use. For
ground applications, triciopyr poses highirisk: to fish and mollusks at the 8 Ibs ae/A and 12 Ibs.
a,t/A use rates. At all use rates, ground applications of triciopyr BEE may acutely affect
endangered fish and mollusks.
Triciopyr Degradates
The tiiclopyr degradate, TCP, is more toxic than the TEA or triciopyr acid and is similar
to fHe BEE in acute toxicity to fish.
Ill' ;;:>:.;ซ .}-:> -\> A "['; jv;;: f./.:!",,,;;'"; ," : /,:. j^'^.!;:,'.;;. -v" ;;".. . ., ' ft:' \' " ' '-.'.:.' '
Summary of Aquatic risk
iyf:''' i 'i . ; :" ':.'. ")? ' -\ ". ' ' '.. ' .
There are no concerns for acute or chronic risks to aquatic organisms from the use of
triclppyr TEA or triciopyr acid. Acute risk to fish and mqilusks (including endangered species) is
probable from direct application of the triciopyr BEE form to shallow aquatic habitats; however,
fate data suggests that exposure will be transitory. Chronic risk from triciopyr BEE is not
expected because of its short duration under environmental conditions (e.g. rapid
photodegradation and hydrolysis in aquatic systems). The Agency is requiring data to better
characterize the environmental fate and toxicity to fish of the triciopyr degradate, TCP.
Non-Target Terrestrial Plants
Triclopvr TEA '" """ " ' " :"
Acute risk and endangered plant species' levels of concern from runoff (ground
application) are exceeded at >9.0 Ib ae/A (non-target plants inhabiting adjacent acreage) and >1.5
Ib ae/A (non-target plants inhabiting semi-aquatic areas). The 1 % drift EEC from around
>j. ,1 ' " jlljillijU i | "" ', , ' nil. , .1. ! 1, "' I'.Jim |i II ilium ' VI' '^~T i ' ! I/ - O **"" ~~
application exceeds LOCs for non-target terrestrial plants at application rates of > 1.5 Ib ae/A and
to endangered plant species at rates >0.375 it> ae/A.
, , ,, ,LQCs from runoff (aerial application) are exceeded at application rates >4.0 Ib ae/A to,
non-target plants and endangered plant species inhabiting adjacent areas and semi-aquatic areas.
The 5% spray drift EEC from aerial application exceeds the LOC for non-target and endangered
species of plants at application rates >0.375 Ib ae/A or higher.
102
'.i!,',1,1" i. "i , ;-Hi
'li,,1,,'M,il/IS 'ill,1* IlliHHII'llll, iJllirW'l K, r!'!'I,!, 11'.
-------
. Triclopyr BEE , , ,
Acute risk levels and endangered plant species levels of concern from runoff (ground
application) are exceeded at rates of application >3.0 Ib ae/A (non-target plants inhabiting
adjacent acreage) and >1.0 Ib ae/A (non-target plants inhabiting semi-aquatic areas). The 1%
drift EEC from ground application exceeds LOCs to non-target terrestrial plants at application
rates >1.0 Ib ae/A or higher. Endangered plant species inhabiting adjacent areas and semiraquatic
areas may be affected at aH application rates of triclopyr BEE..
LOCs from runoff (aerial application) exceeded at application rates >1.5 Ib ae/A for higher
to non-target plants inhabiting adjacent areas and semi-aquatic areas. The 5% spray drift EEC
from aerial application exceeds the LOG for non-target plants at application rates >1.5 Ib ae/A or
higher. Endangered plant species may be affected from aerial application of triclopyr BEE at all
application rates.
Summary of Terrestrial Plants Risk , '
The BEE formulation of triclopyr poses a greater risk to non-target plants than the TEA
formulation. Spray drift from aerial application poses a greater risk to non-target plants than
runoff from ground application. Endangered plant species may be affected from all uses of
triclopyr BEE and TEA. ~;
\
Spray drift from aerial applications poses a greater acute risk to non-target plants than
runoff because foliar uptake of the chemical is more toxic than stem or root uptake. In addition,
more plant species will be exposed over a wider area since spray drift affects a greater area than
runoff. The spray drift risk quotients exceed the level of concern for risk to non-target terrestrial
plants by up to 62 times for triclopyr BEE, as compared with up to 29 times from runoff.
'Additionally, the spray drift and runoff risk quotients from triclopyr TEA exceed the acute level of
concern for non-target terrestrial plants by up to 55 times and 26 times, respectively.
There is a concern for non-target plant species that are protected under various state laws
(i.e. cacti in rangelands) and will be exposed from aerial application. . ...
The triclopyr BEE formulation is more toxic to non-target plants from runoff than
triclopyr TEA. Based on seedling emergence testing, the BEE formulation is 1000 times more
toxic to plants from runoff than the TEA formulation. However, the TEA formulation is more
mobile in a runoff scenario than the BEE formulation. Although triclopyr BEE exposure to non-
target plants is expected to be less from runoff than the TEA formulation, triclopyr BEE'poses a
greater risk to non-target plants.
For risk due to spray drift, the triclopyr TEA use on rice at a rate of 0.375 Ibs ae/A with
one ground application did not exceed the level of concern for acute risk to non-target, non-
endangered plants. However, there is an exceedence (LOC=1.0) to endangered species frorri
"''.'-. 103
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spray drift (1%) associated with ground application. In all other registered uses for both triclopyr
TEA and triclopyr BEE, the level of concern for acute risk to non-target plants and endangered
plant species due to spray drift was exceeded.
The levels o,f concern for risk to endangered plant species are exceeded for both runoff
and spray drift as a result of aerial application of triclopyr BEE. Additionally the levels of
concern for risk to endangered plant species are exceeded by 26 times from runoff and 103 times
from spray drift from aerial application of triciopyr TEA.
' ' ' ..... ' ' : !, " ' ',''''' "! "'" '7 ',,!, ' ' " i "
Non-Target Aquatic Plants
Triclopvr TEA
Only direct application of triclopyr TEA at >9 Ibs ae/A to shallow water results in LOG
exceedances (up to 1.49 times) to aquatic vascular plants and for algae/diatoms. Endangered
species of vascular plants may be affected from triclopyr TEA at rates of>9 Ib ae/A.
Triclopvr BEE
It is expected that there will be significant acute risk to aquatic vascular plants from the
..... : use of triclopyr BEE at application rates greater than 1.5 Ibs ae/A that are made directly to water.
The RQs ranged from 1.3 (at 1.5 Ib ae/A) to 10 (at 12 Ib ae/A) times.
Algae/diatoms are affected at application rates >8 Ib ae/A from runoff to water and
at >L 5 Ib ae/A from direct apphcation to water. The RQs ranged from 1.5 to 2.3 times the LOG
for triclopyr BEE runoff into water and from 1 1 to 88 times of triclopyr BEE being applied
directly to water.
. , , , Endangered species of aquatic plants may only be affected from runoff into water at >1 2
Ib ae?A and from all uses involving direct application into water.
Summary of Aquatic Plant Risk:
Aquatic exposure values did not account for rapid hydrolysis that was observed in a
forestry study (Thompson et. al. 1995) in which the BEE hydrolyzed to the acid within half a day.
Duration of exposure to triclopyr BEE that may result in acute risk is expected to be less than half
Triclopyr BEE is much more toxic to algae/diatoms than to vascular plants. However,
due to the type of testing, it is unknown whether triclopyr BEE will result in killing algae (longer
time for algae to recover) or that it will have an algastatic effect (algae will recover rapidly after
dissipation of herbicide).
104
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There is little risk to aquatic plants from the use of triclopyr TEA. Triclopyr BEE may
pose a significant risk to algae/diatoms and vascular plants if applied directly to water. 'Use sites
such as forestry may result in incidental application to water.
Available data indicate that risk from TEA, BEE use can be summarized as follow:
' Triclopvr TEA
There are no risks to fish, aquatic invertebrates, estuarine/marine species,'
birds or mammals from the currently labeled (0.54 Ib ae/A) granular
formulation of triclopyr TEA.
There exists a high potential for acute risk to birds from the use of
. triclopyr TEA at high application rates.
There is potential for chronic risk to some birds and mammals from
, triclopyr TEA, but this conclusion is uncertain due to the lack of data on
the rate of dissipation of triclopyr on food items.
" 'There are no acute or chronic risk to fish, aquatic invertebrates, or
estuarine/marine species from the use oftriclopyr TEA.
There is a high potential for acute risk to non-target plants from triclopyr
: ' . TEA. ' '''. . ,.
Criteria for restricted use is exceeded for birds and mammals from the use
of triclopyr TEA. . . . ' '
-Endangered species of birds, mammals, and plants ma}' be affected by
triclopyr TEA. ..;'
Triclopyr BEE
There are no risk to fish, aquatic invertebrates, estuarine/marine species,
birds or mammals from the currently labeled (0.54 Ib ae/A) granular
formulation of triclopyr BEE.
.. ." 'There is a.high potential for acute risk to birds from triclopyr BEE.
There is a potential for chronic risk to birds and mammals from triclopyr
. BEE, but this conclusion is uncertain due to the lack of data on the rate of.
dissipation of triclopyr on.food items. .
105
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SfljF'. , LlliS!. t ' i' i'i," <;>'!' .. !:i!':!l ..
fif1 '';ป II!K'JT- ' ! '1:i:;i[" '!l'";: I1 1311 II:T,',
V".''i ;* t'-t < fr ;;:!;:'!:'"> '
;, ' ,:': ;>..._"i, yill,; ;V,'.>;,., ;| iS };j> ;
i: !i;i:::,,;
HIIIIF I.' ' "sI.1''
iiSS'
'"!' iirt.
III! illlv v I; ,'Kl' ;''
IIP 1IIL! '";, ' .'J!' !
:!!!!ll'fi! !;!' .'[.!'
I'd
J'll'1!
1 ?\
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is
There is a high potential for transitory acute risk to fish, aquatic
invertebrates and estuarine/marine species from triclopyr BEE.
There are no chronic risk to fish, aquatic Invertebrates, or estuarine/marine
; species from the use of triciopyr BEE.
:::::: 'There is a high potential for acute risk to non-target plants from triclopyr
'BEE. ' . , , .
Criteria for restricted use is exceeded for birds, mammals, fish, aquatic
invertebrates, and estuarine/marine species from the use of triclopyr BEE.
;~ ; Endangered species of birds, mammals, fish, aquatic invertebrates,
'. ";"*;! ; estuarine/majine species, and plants may be affected by triclopyr BEE.
Tricloovr Degradates
The triclopyr degradate 3, 5, 6-trichloro-2-pyridinol (TCP) appears to be
persistent in aquatic environments.
''i'1'it i ' '" "!,:", ''' S"!1'1"' ',' /I, ' ' "i"11"'1"!"1 1;1'1''1' !' ,i i'!,'i : ", r: -; ," ' ' ',; . ' ,ป , , , , ,
ijKTlBl' " , i .'' "', '. "', . i*1 :ni n'1' !,,! ", i 'ปi,,i,"'::,!,:: ป|:'," i .,::,' ,,,,,;"", , ll,.'!,ii |ll,."|1|; :ซ .;, ' ; ]| ;,:, ป . i,1' ,, , , in ' .
Additional data are required to better characterize the fate and chronic
'
':;. ...,;. _ .fiilp'" .;!:' " f; T >;!;' [,f ,J;';^ , "''';^;-"\'::'$':''\ ''''\
Water Resources
i i IB MI 'There is potential for the major soil degradate of triclopyr,
, i , , i ปiii Kiiiinii i; , * , Linn i i ,i f- ..,,., -s, , i ,,.. "^ , * -J '
tnchlprppyridinol (TCP), to leach to grpundwater from triclopyr TEA or
': ':';.ป tia 'iBEE'. applications.
. f J ,' i *Triclopyr acid is not predicted to persist in surface waters, however, the
',":'-''* triclopyr degradate, TCP, may persist. .
A. De||rmination of Eligibility
a i'
Section 4(g)(2)(A) of FEFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active ingredient
are eligjble for reregistration. The Agency has previously identified and required the submission
of the generic (i.e. active ingredient specific) data required to support reregistration of products
containing triclopyr as an active ingredient. The Agency has completed its review of these generic
data, and has determined that the data are sufficient to support reregistration of all products
containing triclopyr Appendix B identifies the generic data requirements that the Agency
;106
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reviewed as part of its determination of reregistration eligibility of triclopyr,. 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 triclopyr and to determine that triclopyr can be used, with mitigation imposed
by this document, without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore-finds that all products containing uiclopyr as an active
ingredient are eligible for reregistration. The reregistration of particular products is addressed and
a list of additional data required for the technical formulation is contained in Section V of this
document. - ^ ..'-.
The Agency made its reregistration eligibility determination based upon the data required
for reregistration, the current guidelines for conducting acceptable studies to generate such, data,
published scientific literature, and the data identified in Appendix B. Although the Agency has
found that all uses of triclopyr are eligible for reregistration, it should be understood that the
Agency may take appropriate regulatory action, and/or require the submission of additional data
to support the registration of products containing triclopyr, if hew 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 triclopyr, the Agency
has'sufficient information on the health effects of triclopyr and on its potential for causing adverse
effects in fish and wildlife and the environment. The Agency has determined that triciopyr
products, labeled and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks of adverse effects to humans or the environment. Therefore, the Agency .
concludes that products containing triclopyr for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses are eligible for reregistration under the conditions
specified in this RED. . , ' . .
i .''.' , .
C. Regulatory Position
To lessen the human health, ecological, water and food quality risks posed by triclopyr,
EPA is requiring the following mitigation measures for triclopyr-containing products. >
To protect wildlife and non-target plants: ' .
107
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,;|ili;.Til,*;','1!ง[." 1 ; iiiiil-.' I.'"', i i iVป', ,i,.Sill,'""-,'>,l.'ป "!!,":.If 1 'M: J '!" 1 * : i is1;* '' : ; "''i';';'.','.-<*'' < '' M' ;'' "" ปS ''
maximum rate of application from the current 12 Ibs/ae/A to:
1 Ib/ae/A/year on pasture and rangeland and all sites where cattle can be grazed
6 Ibs/ae/A for forestry applications
8 Ibs/ae/A for all otheruse sites of triclopyr BEE
9 Ibs/ae/A for all other use sites of triclopyr TEA
It should be noted tliat the reduction to 1 Ib/ae/A/year on pasture and rangeland is
required because the available residue data do not support applications in excess of that amount to
pasture and rangeland. However, this reduction in maximum rate also serves to reduce the
calculated risk to the non-target organisms found in and adjacent to those areas. It should also be
noted that DowElanco has provided the Agency with a statistical analysis supporting a maximum
of 2 Ibs/ae/A for the range and pasture use, which the Agency is currently evaluating.
-3|equire labeling; to implement spray drift management practices, based on recommendations of
f'i;1;'11":!'* ;L; 4ง'Spray Drift Task Forcer'' ' "
-Specify appropriate application intervals on all product labels.
To protect water resources:
I I III II I * , , , ,j,, ii.,,,, ,,, : : n i ,,,,, i,, | ,,,,i .11, , ,| .,,,', , . , ,, ปi;.., ,, , , ...,,", ,.i,,, ; t ,
- In addition to the above mentioned measures, triclopyr labels must also bear the following
warning: "This chemical has properties and characteristics associated with chemicals detected in
groundwater. The use of this chemical in areas where soils are permeable, particularly where the
water table is shallow, may result in groundwater contamination. "
To protect food quality:
-Limit applications of triclopyr on range and pasture and all sites where cattle can be grazed to 1
Ib/ae/A/year.
-Label amendments are required to remove all Pffls for grass forage and to specify a 14-day PHI
for grass hay, based on the reassessed tolerance for this commodity.
-Retain the established 3-day preslaughter interval.
i -Retain the current restriction against grazing lactating dairy animals until the next growing
season. ' ' "" """' " ' ' _ '' ' '""" " ' '_'" i i """.'"',,"','", .'. .'. " ' ,-'
-Remove all conflicting grazing restrictions/instructions on current triclopyr labels.
Also, in conjunction with the food uses of triclopyr, registrants must develop residue analytical
methods to substitute reagents less hazardous than diazomethane and benzine.
-------
To protect homeowners: . -
-Restrict re-entry to treated areas until sprays have dried and dusts have settled.
-Retain/require label language to avoid eye and skin contact during and Rafter application.
To protect workers: . ' ,
-Establish REIs and early entry PPE , ' , '
- Add additional health and safety instructions to labels as specified in Section 5.
The following.is a summary of the Agency's regulatory' position and rationale for
managing risks associated with use of triclopyr. Where labeling revisions are imposed, specific
language is set forth in Section V.B.2 of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for triclopyr, 'with amendments and
changes as specified in this document,- meet the. safety standards under the FQPA amendments to
section 408(b)(2)(D) that there is a reasonable certainty of no harm for the general population. In
reaching this determination, EPA has considered the 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 triclopyr and other compounds that may have a
similar mechanism of toxicity.
The Agency .considers that residential exposure to triclopyr from its use on home gardens
and lawns is likely to be negligible because no dermal endpbint of concern has been identified, and
inhalation exposure is likely to be minimal. Therefore, EPA has considered only acute and
chronic exposures from dietary sources and drinking water in its aggregate risk assessment.
In assessing acute aggregate dietary risk EPA has used a maternal NOEL of 30 mg/kg/day
from a developmental study in rabbits. Because of the selected endpoint, the sub-population of
females 13+ years, is the subgroup of interest. The risk assessment assumed 100% of the crop
was treated and that there would be tolerance level residues on all treated crops, as well as an
upper bound estimate, of triclopyr residues in drinking waterresulting in a significant over
estimate of dietary exposure. Notwithstanding the extremely conservative exposure assumptions,
the aggregate acute dietary MOE was calculated to be 1250, well within the acceptable range.
. r ' , . . . - - , . '
. The Agency used the same conservative exposure assumptions described above to
estimate the chronic aggregate dietary risk from triclopyr residues in food and water. Current
. 109 ' ' . .''.'
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(. lit'
registered uses utilize only approximately 16% of Hie RfD for the general population. Therefore,
the Agency concludes that the aggregate risks of triclopyr for the general population are not of
concern.;,' ;., n '. .. "V ' ;;; ' ;.;;' ;:"",',i.'.".', ',';,."."; "I '' ;,' ' ' '-
Because triclppyr shares a common metabolite, TCP, with the insecticide chlorpyrifos,
E]PA has also considered the potential for aggregate exposure to TCP. Again, usins very
'^!!'!1!!!1'!'-!'',1' |ij||W .p. ./iv; ;,:,n ,., I,./,, ,, ./ iiijiiiti; .i,,/;.;,'.1 *&} . "wi/,** \n' .. ,,,,. ,!,; .'.,,r,,,ll,3ni!r'',l,.i Vtf,,. ซ,,, .,, ,, ,;,,,! :. ,, ., .,, , ...X ' V J
;'f If >;:. protective exposure assumptions, for the population sub group of-concern, females 13 + years, the
,,L!' ,j,.i.,' - , luiniii ,ilf,i , 1,1 i ,*i 'in*. ,.ซ ,, ,i, , ,i.n i,:,!:,. ife* ., , . , * ri , iSr., 4: ... ซ ' ,, * ,,, , V '
'";|p' Agency calcul^ated an MOE of 600 for acute aggregate dietary risks from TCP.
Tfie Agency concludes that the existing uses of triclopyr and chlorpyrifos are unlikely to result in
lEi';1 '/I C": dietary risks of concern from TCP for the general population.
Hi'.
Mil Hit,
IIill*,I
i w'
i1 :,",n
b. Determination of Safely for Infants and Children
EPA has determined that the established tolerances for triclopyr, with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 40S(b)(2)(C) that there is a reasonable certainty of no harm for infants and children. The
safety determination for infants and children considers the factors noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the
'specific consumption patterns of infants and children, as well as the possibility of increased
susceptibility to the toxic effects of triclopyr residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from triclopyr residues, EPA considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other information.
Based on the current data requirements, triclopyr has a complete database for
develppmentai and reproductive toxicity. Reliable studies cited earlier in this document indicate
no special serisitivity of young organisms to triclopyr (see Section lilb.). Therefore, the Agency
has concluded that an uncertainty factor of 100 is adequate to protect infants and children.
" EPA estimates that the residues of triclopyr in the diets of infants and children account for
approximately 3% of the RfD and residues in drinking water could account for up to an additional
46% of the RfD, using the same conservative exposure assumptions described above for the
general population. Thus the aggregate chronic dietary exposure for infants and children could
utilize up to approximately 49% of the RfD.
The Agency has also considered the potential for chronic aggregate dietary exposures to
TCP and calculated that known, likely sources of TCP could account for 90% of the provisional
RfD for TCP for the most highly exposed sub-group, non-nursing infants less than one year old.
Thjjs the Agency concludes that aggregate risks for infants and children resulting from triclopyr
uses and the combined sources of the metabolite TCP 'are not of concern.
110
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The Agency has not yet made a final decision concerning the possible common mechanism
of toxicity and the potential for cumulative effects of triclopyr and other compounds. Therefore,
for the purposes of the tolerance reassessments in this RED document, EPA has considered the
risks of triclopyr and TCP only. , , -
In deciding to continue to make reregistration determinations during the early stages of
FQPA implementations, EPA recognizes that it will be necessary to make decisions relating to
FQPA before the implementation process is complete. In making these early, case-by-case
decisions, EPA does not intend to set broad precedents for the application of FQPA to its
regulatory determinations.. Rather, these early decisions will be made on a case-by-case basis and
will not bind EPA as it proceeds with further policy development and 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. , .
Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether certain substances -
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine effect..." The Agency is
currently working with interested stakeholders, including other government agencies, public
interest groups, industry and research scientists in developing a screening and testing program and
a priority setting scheme to implement this program. Congress has allowed 3 years from the .
passage of FQPA (August 3, 1999) to implement this program. At that time, EPA may require
further testing of this active ingredient and end use products for endocrine disrupter effects.
2. Tolerance Reassessment
Tolerance Reassessment Summary
The Triclopyr Salts and Esters Phase 4 Review (4/25/91, J. Smith) has determined that a
clarification of the tolerance expression is warranted to reflect application of the butoxyethyl ester
and triethylamine salt of triclopyr. Therefore, the tolerance expression must be revised to
"residues of triclopyr... as a result of the application/use of butoxy ethyl ester of triclopyr and
triethylamine salt of triclopyr." .' . . ,
The Agency's FIED Metabolism Committee has concluded (7/15/96) that the residue to be
regulated in grass and rice commodities and milk, poultry and eggs is triclopyr per se. The
residues to be regulated in meat and meat byproducts are the combined residues of triclopyr and
111
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the metabolite 3,5,6-trichloro-2-pyridinol (TCP). A summary of tolerance reassessments, with
respect to the reregistration of triclopyr uses on grasses and rice, is presented below.
Tolerances Listed Under 40 CFR SI80.417(a):
The tolerances listed in 40 CFR ง180.417(a) are expressed in terms of the combined
residues of triclopyr and its metabolites 3,5,6-trichloro-2-pyridinol and 2~methoxy-3,5,6-
trichlprppyridine. Sufficient field trial data are available, contingent upon compliance by the
registrant in adapting the required label amendments, to ascertain the adequacy of the established
tolerances for the following commodities, as redefined according to the-Agency's metabolism
committee conclusions of 7/15/96: grasses, forage; and grasses, forage, hay. See Table 56 below
for required revisions to commodity names.
The reassessed tolerances for grass forage and hay are 500 ppm and 200 ppm. These
reassessed tolerances are contingent upon compliance by the registrant in adopting the required
label amendments (i.e., a maximum single application rate of 1 Ib ae/A, a maximum of
1 application/season, removing the PHI/POI for grass forage, a 14-day PHI for grass hay, and a
prohibition on grazing lactating dairy cattle until the next growing season).
Tolerances Listed Under 40 CFR SI80.417(b):
The tolerances listed in 40 CFR ง 180.417(b) are expressed in terms of the combined
residues of triclopyr and its metabolite 3,5,6-trichloro-2-pyridmol.
Based on the recommended changes in feeding/grazing restrictions and application rates to
grasses, adequate data are available to ascertain the adequacy of the established tolerances for the
following commodities, as defined in 40 CFR ง180.41703): meat, fat, and meat byproducts
(except liver and kidney) of cattle, goats, hogs, horses, and sheep; and liver and kidney of cattle,
goats, hogs, horses, and sheep. See table below for recommendations in revisions to commodity
names. The tolerance for milk is adequate as redefined according to the Agency's metabolism
committee conclusions of 7/15/96., i.e., to be expressed in terms of triclopyr per se.
The established tolerances for rice grain, rice straw, eggs and poultry commodities were
recently established (60 FR 4095, 1/20/95) in conjunction with PP#1F03991. These tolerances
'are adequate as redefined according to the Agency's metabolism committee conclusions of
7/15/96, i.e., to be expressed in terms of triclopyr per se.
: 112
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Table 55: Tolerance Reassessment Summary with Respect to Uses of Triclopyr on
Grasses and Rice.1
Commodity
As Cteimet!
rn-i nn M- f, jrrr. -tyry. .T , , , .
Cacreal Tolerance
, ' :
Tolerance Reassessm-eat
(ppsx)
; C<3Esmซnt/ " "" ' , ', ,
fQazretitC&mmodity Definition/
,, - s " ' Tolejraaees Listed Under 4ซCFR งJm4I7fa}V
Grasses, forage
Grasses, forage, hay
500
500
500
. . t 200 '
Redefine as triclopyr perse, ,
I'Grass, forage]
Redefine as triclopyr per se.
f Grass, hay]
Tolerances Listed Under 40 CFR ง180.417(b) 3:
Meat, fat, and meat
byproducts (except
liver and kidney) pf
cattle, goats, hogs,
horses, and sheep;
Liver and kidney of
cattle., goats, hogs,
horses, and sheep
Milk
Rice, graint
Rice, straw :
Eggs ' - ';
Meat, fat, and meat
byproducts (except
kidney) of poultry
Fish
Shellfish*. -
Water, potable
0.05
/
0.5
0.01
0.3
: 10.0 . '
,0.05
0.1 ,
0.2
0,2
.' 0.5 '
0.05 . , '
. 0.5 " .
0.01
0.3 '
' 10.0
' 0.05 '
0.1
Redefine as friclopyr per se.
Redefine as triclopyr per se.
Redefine as triclopyr per se.
Redefine as triclopyr per se.
Redefine.as triclopyr per se. .
These temporary tolerances, Which were established in conjunction with a
petition (PP#1F03935) for the registration of triclopyr in aquatic areas,
are not addressed in this RED and are not subject to reregistration.
1 Tolerance reassessments are contingent upon label amendments required in this document.
- Currently defined as triclopyr and its metabolites 3,5,6-trichloro-2-pyridinol and 2-methoxy-3,5,6-
triichloropytidine. , . -
3 Currently defined as triclopyr and its metabolite 3,5.6-trichloro-2-pyridinol.
Temporary Tolerances and Pending Tolerance Petitions:
Temporary tolerances have been established for fish and shellfish at 0.2 ppm, and a temporary
Allowable Residue Level in Drinking Water (ARLDW) in potable water of 0.5 ppm has been
established under PP#6G3306. These temporary tolerances expire in December 1998. Petitions
for the registration of triclopyr in aquatic areas (PP#1F03935) and apples (PP#2F4104) are
currently pending. , . '>
113
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tip i
1;; ..... i ...... ;;' v;1 ' IBM i ..... ? '. iTfCBSi ....... ซ i;i1' ' ..... SIP ' ' t; ...... '. "< : .................. :": .: w w in1.;1. ซ cf.i'i."iซ'ifcr*1:! i "i;;" ti- ; :i^ ': ru? "ซป ' " ..... ป ' ;i ..... ; ...... '
*fflt->5fi'1' i'l 'J.. Codex Harmonization,' '.'.''..
i'l'iilR'
ift
ft:1::
;i,Miป -:, 'lililHii.,"1]!;1 r1: t ,:' M;;.: ' i iiillllil' '.-"",";",, :i -,,?, i1." MI? ','MS:,V "i111,!;11,::!;;: .. j vii '
i$h'!r:f :=!>{ i!" \,, , !ij|jere are'.nq'l established or proposed Codex MRLs for triclopyr residues. Therefore, there are
!;|ii'i!|l|| i'' Ji !ll'j|i' , 'in,' , ซ i, ,,,,<,,
no issues of compatibility with respect to U. S. tolerances and Codex MRLs.
INK''';' ,J f ' * r | , - ' ijisl" I ''I.'!. i, >"'{ ;il; ' ,'';.1" si., filli:, :i Si;!1" ,i;;; ...!:,,;'' > i I | : I
**
mi&i <:<'} fr ;" '-1:Selective herbicides such as, triclopyr are used to control undesirable vegetation, thus
illlJlll'11 KChi . i Jti. :;/! JjllJ !|f ".'fi;',,,;. 'i'1 il^h!1!1", "I'J'I;!!,1!11 J^11 iliillll!'..i.'J[l; '.",!;:",'"''."; !;,f ." ||iiir jtiyilllli1 l,:illrtl-f i, ,. ,, , i,, ,rll , V /
^Il^'i^:;'. "i:'! '',, effiouraging desirable plant sjpecies. Selective vegetation control is less disruptive .of wildlife
habitat titian mechanical methods such as mowing, sawing and chopping. Selective vegetation
IIP Inllin,A, 'II ' i1'!1,1!.11!, / Hill'IR !:: -, V,:1! V'. IM li-'IIIIPillli nil1 "'I 'V: '"i.'l111 <"ป ii I'liii-ilr /,!! , . ; i'lMillii.;.!114.Vi'l'i ^!,? V* i,,,^, ,V , ^^^v^w. v
tnanagement reduces soil erosion compared to non-selective herbicides or clear cutting.
Overgrown or unmanaged vegetation is a fire and safety hazard along roadsides, railroads and
Utility rights-or>way. Other benefits include reduced cost of road and railway repair and increased
visit
IIIB IH'iiii'L:!-
4,
I , -'V
Ecological Risk Mitigation
-I at! '', ' ,ivv., ." ..'. , &S-. ; -i.
K.Th,e.,triplopyr ecological risk assessment shows that various levels ofxx>ncern (LOCs) were
exceeded for acute/chronic tqxicity to plants and animals. Shaded areas in the table below
itij|ca.te usesi.lh'a.t.rflay still exceed LOCs after mitigation measures are adopted.
'able 56: Summary of Potential Ecological Risks
l!|i Ililftir'"!""'1 i'iln1'!1. ' '' , i''1!'1!*]11"
1 llllilllDI ' II, rซ'"i;i > " " hll, <<
i in i i ii
j^S^^f1!':-1:;":
Birds
Mammals
Insects
Aquatic
species
"ffi^-lSiiil^gk
TEA (Non granular products)
- 12.12 Ibs ae/A on short grass
BEE (Non granular products)
- 12. 12 Ibs ae/A on short grass
High acute risk not exceeded
Not expected to adversely affect insects
BEE
Non-Ae Uses (forestry, drainage. etc.V
if^y'^v^-"-;--'-;-:-^^^'^':'^'1-:-:-:-:^-:-:-;:-:
$kL$. yss^sfmsm^m
>8.0 Ibs ae/A for invertebrates
Ag Uses
-(aerial application) 8.0 Ibs ae/A for fish
-(ground application) > 8.0 Ibs ae/A for fish
'CfemcjRjsk
TEA and BEE (Non granular products)
9 and 12. 12 Ibs ae/A
TEA and BEE (Non granular products)
^5 ly's.ae/A, oji stood grass
>S lt!j Ibs ae/A ซn forage and small insects
Not expected to adversely affect insects
Chronic risk not expected
114
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Terrestrial'
Plants.
TEA
Ground application
>9.0 Ibs ae/A from runoff from adjacent
acreage
> fjflfas ae/A for serM-a-cpati
Aerial application
BEE
Ground application
5&Q Ibs-aeMfe3m rgmpff %ia adjacent
areas
Aerial application
:ฃ tS Ifas -ae/Afor plsats jnliabiting adpceat
areas a&d semi .aqaatio, plants _
Not accessed for plants
Aquatic
Plants
TEA '
> 9.0 Ibs ae/A direct application only
BEE
>\% Ibs ae/A Direct ajppficatib-ii^'vascalar
planks)
> 8.0 Ibs ae/A from runoff (algae/diatoms)
> 1,
Not accessed for plants
EPA has worked with DowElanco to define mitigation measures including, label improvements
to reflect lower maximum application rates and implement spray drift management practices, that
will reduce calculated risk to non-target organisms. The highest application rate (12 Ibs/ae/A) -
that was used to calculate RQs will no longer be permitted. The maximum application rate
allowed on pasture, rangeland, and all other sites where .cattle are grazed will be 1 Ib/ae/A per
year. (DowElanco has requested a reconsideration of available data to allow 2 Ibs/ae/A on
pasture and rangeland). Maximum application rate for forestry will be 6 Ibs/ae/A. For all other
sites, for the BEE formulation's the maximum allowed rate will be'8 Ibs/ae/A and 9 Ibs/ae/A for
TEA formulations.
As shown in the table above, after taking into account mitigation measures, some exceedances
remain. These include: .
-chronic risk to mammals from both the BEE and TEA formulations feeding on short grasses
treated at rates in excess of 1.5 Ib/ae/A, and on forage and small insects at > 3.185 Ibs/ae/A;
-acute risk to fish species from the BEE formulation at rates in excess or 1.5 Ibs ae/A applied
to forests; and
-acute risk'to various classes of non-target plants.
Several factors lessen the Agency's concern regarding these remaining calculated exceedances:
115
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Chronic Risk to Mammals
The residue values (Kenaga & Hperger) used m EPA's screening assessment are based on 0 hour
exposures anci do not consider any degradation processes. Whether plants treated with triclopyr
remain palatable long after treatment is unknown.
ii ' , .. Hiiii '," I,:- :"' .I'-'iiii v "", :" ;' ',, ' . ,". /; : .<.', : i . '. . ,
Acute Risk to Fish
Acute risks to fish were calculated assuming direct application to shallow aqiiatic habitat.
Flowing water systems such as forested watershed would result in rapid dissipation of triclopyr.
Current registered labels, with the exception of rice, do not allow direct application to water.
Acute Risk to
Because triclopyr is an herbicide, EPA expects calculated risk quotients to exceed levels of
concern for some non-target plants. In order to minimize off-site movement of triclopyr, EPA is
requiring that spray drift management practices be implemented via triclopyr labeling.
In making a reregistration decision the Agency weighs the ecological risk against the benefits
derived from using a chemical. The risk reduction measures required in this RED, namely
reductions in application rates and requirements for spray drift management are consistent with
those imposed for other chemicals with similar risks. Because of this risk mitigation, coupled with
the benefits of vegetation management from using triciopyr, the Agency does not believe the
remaining ecological risk to be unreasonable.
5.
Ground Water
EPA's pesticides in Ground Water Database reports sampling for triclopyr in Maine, Texas,
Virginia, and Vermont. A total of 379 wells were sampled and 5 wells were found to contain
triclopyr residues. The major degradate of triclopyr, TCP, is both mobile and persistent. EPA is
requiring a label advisory warning users that under certain conditions, use of this chemical may
result in groundwater contamination. Refer to section V.B.2 for specific language.
' I: till I " *!' ซ ' '" 'i. , ', T,,, ' .i1;, - i, ' !: ,,'. " ",!' '! ''!;!' 'i '! , ' . I1 ... ; , . "i ,h " ,:,|. > ,,:' , ' ,+: ! |, ,.| ., ' " ' ,
I I Vlil'S i ': ' :-v , " .',,K", I' ''..>: ;';\."?>':: I''< ,if I"-'.,A<'W': *.:: '!" If'' .' I; , , , ' .'.' .: '.
6, Occupational Labeling Rationale
('ft" ,'" " '" "''irr ,'V; .ill, , !,. !', I! ป"> J'lS'i:/;1':"'!1;;; -,,..'. I ',]'! 1 ,".,! .".', , 1,1. ' Fi "
I !iป '!'' ' 'H;':^., (<ซ;. ': '<'A^r.'-. :,',,:.."!':'!>, ป: ;;-;', w*:. . !/
Occupational and Residential Labeling Rationale/Risk Mitigation
The Worker Protection Standard^ (WPS)
The 1992 Worker Protection .Standard for Agricultural Pesticides (WPS) established certain
worker-protection requirements (personal protective equipment, restricted-entry intervals, etc.) to
be specified on the label of all products that contain uses within the scope of the WPS. Uses
within the scope of the WPS include all commercial (non-homeowner) and research uses on
lie
-------
farms, forests, nurseries, and greenhouses to produce agricultural plants (including food, feed, and
fiber plants, trees, turf grass, flowers, shrubs, ornamentals, and seedlings). 'Uses within scope
include not only uses on plants, but also uses on the soil or planting medium the plants are (or will
be) grown in. . '
,- L, " - '
At this time some of the registered uses of triclopyr are within the scope of the Worker
Protection'Standard for Agricultural Pesticides (WPS). Uses that are outside the scope of the
WPS include use: ' -
a on pastures or rangel-ands, ; . _ .
ซ. or in or around animal premises,
ซ on plants grown for other than commercial or research purposes, such as residential lawns
ป on plants that are in ornamental gardens, parks, golf courses, and public or private lawns
and grounds and that are. intended only for decorative or environmental benefit. (However,
pesticides used on sod farms ARE covered by the WPS).
IB in a manner not, directly related to the production of agricultural plants, including, for ,
example, control of vegetation along rights-of-way and in other noncrop areas.
'' 'X'
Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators, etc.)
For each end-use product,,,PPE requirements for pesticide handlers are set during refegistration
in one of two.ways: .'.'.'
1. If EPA determines that no. regulatory .action must be taken as the result of the acute effects or
other adverse effects of an active ingredient, the PPE for pesticide handlers will be based on the
acute toxicity of the end-use product. For occupational-use products, PPE must be established
using the process described in PR. Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient must be taken as the result of
very high acute toxicity or certain other adverse effects, such as allergic effects or systemic effects
(cancer, developmental toxieity, reproductive effects, etc.): .
ป In the RED for that active ingredient, EPA may .establish minimum or "baseline" handler
. PPE requirements that pertain to all or most end-use products containing that active
ingredient. '.
a These minimum PPE requirements must be compared with the PPE that would be
, designated on the basis of the acute toxicity of the end-use product.
IB The more stringent choice for each type of PPE (i.e., body wear, hand protection, footwear,
eyewear, etc.) must be placed on the label of the end-use product. '
Personal protective equipment requirements usually are set by specifying one or more pre-
established PPE units sets of items that are almost always required together. For example, if
chemical-resistant gloves are required,'then; long-sleeve shirts, long pants, socks, and shoes are
assumed and are also included in the required minimum attire. If the requirement is for. two layers
-."'.'' 117 ' '
-------
of body protection (coveralls over a long- or short-sleeve shirt and long or short pants), the
minimum must also include (for all handlers) chemical-resistant footwear and chemical-resistant
headgear for overhead exposures and (for mixers, loaders, and persons cleaning equipment)
chemical-resistant aprons.
Occupational-Use Products
WPS and NonWPS Uses: EPA's evaluation of the dermal and inhalation toxicity of triclopyr
indicates that significant toxicity from either route of exposure is unlikely. As a result of this
evaluation, the Agency has determined m'at risks" to handlers, for both WPS and non-WPS uses,
do not warrant the establishment of active-ingredient-based minimum personal protective
equipment or engineering-control requirements that would apply to all triclopyr end-use products.
Handler PPE requirements, both WPS and non-WPS, for triclopyr are to be based solely on the
acute toxicity of individual end-use products.
Homeowner-Use Products
EPA is notpstaJjlisMngminimum (baseh'ne) handler PPE for triclopyr end-use products that are
handed primarily for homeowner use. Any PPE for homeowners will be based on the acute
toxicity of the specific end use product.
Post-Appiication/Entry Restrictions
S, ' !;,,', '; ' !
Qccupational-Use Products (WPS Uses)
." ' ' ' .1
Restricted-Entry Interval: Under the Worker Protection Standard (WPS), interim restricted-
entry intervals (RSrs) for all uses within the scope of the WPS are based on the acute toxicity of
the active ingredient. The toxicily categories of the active ingredient for acute dermal toxicity, eye
irritation potential, and skin irritation potential are used to determine the interim WPS REI. If one
or more of the three acute toxicity effects are in toxicity category I, the interim WPS REI is
established at 48 hours. If none of the acute toxicity effects are in category I, but one or more of
the three is classified as category II, the interim WPS REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or II, the interim WPS REI is established at 12 hours.
A 48-hour REI is increased to 72 hours when an organophosphate pesticide is applied outdoors in
.arid areas. In addition, the WPS specifically retains two,types of REI's established by the Agency
pripr to the promulgation of the WPS: (1) product-specific REI's established on the basis of
adequate data, and (2) interim REI's that are longer than those that would be established under the
WPS.
During the reregistiration process, EPA considers all relevant product-specific information to
decide whether there is reason to shorten or lengthen the previously established. REI.
118
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During the reregistration process, EPA determined that the restricted-entry interval for all
occupational-use products that contain triclopyr TEA and are within the scope of the Worker
Protection Standard for Agricultural Pesticides (WPS) should be 48 hours. The basis for this '
decision is that triclopyr TEA is categorized as toxicity category I (severe) for eye irritation
potential and also is classified as a skin sensitizer.
Early-Entry PPE: The WPS establishes very specific restrictions on entry by workers to
areas that remain under a restricted-entry interval, if the entry involves contact with treated
surfaces. Among those restrictions are a prohibition of routine entry td perform hand labor tasks
and a requirement that personal protective equipment be worn. Under the WPS,'these personal
protective equipment requirements for persons who must enter areas that remain under a
restricted-entry interval are based on the acute toxicity category of the active ingredient.
: During the reregistration process, EPA considers all relevant product-specific information to
decide whether there is reason to set personal protective equipment requirements that differ from
those set through the WPS.
The RED requirements for early-entry personal protective equipment are set in one of two ways:
1. If EPA determines that no regulatory action must be taken as the result of the acute effects or
1 other adverse effects of an active ingredient, it establishes the early-entry PPE requirements on
, the basis of the acute dermal toxicity category, skin irritation potential category, and eye
irritation potential category of the active ingredient.
2. If EPA determines that regulatory action on an active ingredient must be taken as the result of
very high acute toxicity or to certain other adverse effects, such as allergic effects or delayed
effects (cancer, developmental toxicity, reproductive effects), it may establish early-entry PPE
requirements that are more stringent than would be established otherwise.
Since both triclopyr TEA and BEE are classified as category IV for skin irritation potential and
El for acute dermal toxicity, and EPA has determined that no regulatory action must be taken due
. to the acute effects or other adverse effects of triclopyr, the PPE for dermal protection required
for early entry is the minimum early-entry PPE permitted under the WPS. Since triclopyr TEA is
classified as category I for eye irritation potential, protective ey.ewear is required.
WPS Double Notification Statement:
"Double" notification is the statement on the labels of some 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 is imposed if the active
ingredient is classified as toxicity category I for acute dermal toxicity or skin irritation potential.
EPA has determined that double notification is not required for triclopyr end-use products.
' 119 /
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, , , .....
...... rl'il,1' '" ,!ii#
' -1::;':: v,;.
ill.; f i
; .'. iDccupational-Use Productsr(NonWPS Uses)
Since fiPA has concerns about post-application exposures to persons after nonWPS
occupational uses of triclopyr TEA (classified as toxicity category I for eye irritation potential and
is a skin sensitizer), it is establishing entry restrictions for all nonWPS occupational uses of
triclopyr TEA end-use products. Entry will be restricted until sprays have dried and dusts have
'''JIIPW'..'^,,1 ,"!ป'"!', ..... 'i it "I.,,, ..... '.,! r,!|.i:i, .......... , ..... , ...... H,,.^,. .,.!,.., ..... ., , ......... . ........ ,-. ..... ,i, v . ...... ..... ,,.i IN. ,ซ' ....... ...ujiiMir t, ป ...... -,,,\,' , :: ipt',,, ' 'H ..... 1,1, i,,,iv :!!! ............. ..... , . u , ...... , , , .....
settled. For specific requirements, refer to Section V of this document.
Homeowner-Use Products
...... in I i ' W'l 'K.^fii : ? ' %-; '
i:;
has concerns ^ about, gpst-application exposures to persons after homeowner
; :'i|iii:i'''';^ri."ap^iciations of triclopyr ^TEACclassified as toxicity category^ I for eye irritation potential and is a
'!' ..... ''!'": .*: =;=: '"'skiE sensitizer),, it is ..... establishing entry restrictions for all homeowner uses of triclopyr TEA end-
: ; : : i : ; use products. Entry will be resfiicted until sprays have dried and dusts have settled. For specific
requirements, refer to Section V of this document.
'
recpgnizes the apparent discrepancy between establishing a 48 hour reentry interval for
.tricgpyr TEA iises Mat are covered by the "WPS and setting a seemingly lesser standard for non-
'"W^l, u^es^'inciudini homeowner ;groducte,^^^^ "urttil sprays have dried" or
'^ilM ,^^eii HWl^ili Bj6' ^^??y ^^eY?s, l1?^ ^S? ^^^l,01! !s, ,ffs!!งe^, %c,ause ?? fundamental
differences in the ..... frequency arid duration 'of &e11exi3bsu^es'1 involved'. WPS uses are generally
i,; .1 llljllill'.i'i'.fi,!:; " i, !!iii,'ii!ซNiiiLiJ ..... ;!!!""'! ii* ':.' ,i l'i+!!!llil'|i| n,,,i'ป r,;11 , .lr'i"'i ' , .;: ....... v",,!,, n ..... <,i;; ....... ; ..... miEiivn .ปป y.i ,,,,"n ,a,ii",, iiii 'hi. joum"1 "".'i1111:1:!!,,., ,!" mi ..... in .................. :: ...... o\ ..... inn|i,, ' III; i ,,/' ; , ,,|, ,,11,'j: , ' 'I!' iHIIHI'l n ,' ' ป ' I . , , ...... ........ "'''"'' ,'M' T 11 "! illllLI ...... I1!" I' ill: i; ''!! '' , II I'M! ..... I iil'jJI'i'n! r1 , In'1' " ..... I! ..... I' ..... II "1<<" u" ' ,'i ii!1'1 I il1 ซ.il:l<: ปซ"' ' V "! 11!,, ! I!*, ' ' i '!' , ' ..... , '"' '< ' > I ' i ' '''
1368^6, that,,a flpffle^wner .WQuJ.cl be ..exposed to would be much less (due to lower percent ai in
homeowner products and lower application raties^ than an agricultural worker, and the duration of
expSsure would Se shorter. ..................................... ' ...................... :
*
f. '.Other Labeling Requirements
- Th6 Agency is also requiring other use and safety information to be placed on the labeling of
i; all cpd-use products containing triclopyr. For the specific labeling statements, refer to Section V
of this document
7.
iL' ~j
Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse impacts.
The program would require use restrictions to protect endangered and threatened species at the
county level. Consultations with the Fish and Wildlife Service may be necessary to assess risks to
Jill ill :,
ฅ!?; i
',120
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newly listed species or from proposed new uses. In the future, the Agency plans to publish a
description of the Endangered Species Program in the Federal Register and have available
voluntary county-specific bulletins'. Because the Agency is taking this approach for protecting
endangered and threatened species, it 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. ' .
8. Spray Drift Management
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, whose membership consists 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.
' ' '. , i '.'. f ' ' ' . . ' '
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration of
both manufacturing-use and end-use products. .
t . " -
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of triclopyr for the above eligible uses has
been reviewed and determined to be substantially complete. The Agency is requiring additional
confirmatory data to better characterize the fate and chronic toxicity to fish of triclopyr,
specifically its 3,5,6-trichloro-2-pyridinol (TCP) degradate, in the aquatic environment. A fish
early life stage.study ( guideline 72-4) using rainbow trout coho or chum salmon is required for
TCP because aquatic concentrations of TCP may be greater than 1% of the LQ0 (1.5 ppm) for
rainbow trout (the most sensitive species). A one year duration aerobic metabolism study
(guideline 162-4) is also, required. Previous aerobic aquatic metabolism studies have not fully
characterized the degradation of TCP. The Agency encourages registrants to conduct the new
aerobic metabolism study using natural waters and sediment from native habitat for the fish
species selected for the early life stage test. . ...
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with F3FRA, 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: ,
121
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!; I.V,
,,.,4K- 'i;
i^M/'i'ti1!,!1''1 ''.iKi,:!'!'! Jiiii '
lililL-i I Jit! it "ii!l;,'i!. .
I'll II
"Tnis grodjict may bemused to^fomulateLproducts^ for specific use(sj not listed on the
'jl^, la|el ijf,ijt^i;ii|op|}u||to.r, ^ser group or grower has complied with U.S. EPA.
submission requirements regarding the support of such use(s).
"This product may be used to formulate products for any additional use(s) not listed
on the MP label if theformulator, user group or grower has complied with U.S. EPA
submission requirements regarding the support of such use(s).
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(|)f2)(B) of FMIA calls for the Agency to obtain any needed product-specific data
regarding me pesticide after a determination of'eligibiiity has been made. The product specific
data requirements are listed in Appendix D, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies.
122
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2. Labeling Requirements for End-Use Products
The following amendments are required to all labels that contain range and-pasture sites,
including lights of way, fence rows, or any area where grazing or harvesting is allowed.
(1) specify a maximum single application rate of 1 Ib. ae/A and only one application
per growing season;
(2) remove all preharvest and pregrazing intervals for grass forage except for the
existing restriction against grazing lactating dairy cattle until the next growing season;
(3) specify a 14 day PHI for grass hay; and , ' ;
(4) retain the existing pre-slaughter interval of 3 days.
Labels-for both triclopyrBEE and TEA formulations that contain forestry applications must
specify a maximum of 6 Ibs/ae/year for that site.,. ;
For all otheruses; triclopyr BEE labels must specify a maximum of 8 Ibs/ae/A/year, and
triclopyr TEA labels must specify a maximum of 9 Ibs/ae/A/year.
To protect water resources:
- In addition to the above mentioned measures, triclopyr labels must also bear the following
warning: x
"This chemical has properties and characteristics associated with chemicals detected in
groundwater. The .use of this chemical in areas where soils are permeable, particularly where the
water table is shallow, may result in groundwater contamination. " .
' For all uses except rice, labels must specify:
i '.' -
"Do not apply directly to water." . . '
Occupational/Residential Labeling
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain triclopyr, the product labeling
must be revised to adopt the handler personal protective equipment/engineering control
requirements set forth in this section. Any conflicting PPE requirements on the current labeling
must be removed. ' -',
123
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ซi"! : !!,,:i>!!i",;; ..... s , labeling section "Hazards to Humans (and domestic animals)."
;;;v"! ;;.'''*;. Entry Restrictions '
Till, lllllllJ I"1' Ml"'1',1!.',!"1.!;' !;, Hi "' lull'l"! .11 .7 ..... ,,, , i ป ..... ...... .......... ........ ...... ..... , < , ,. , ...... ........... . I- ....... . . ............... . .......... , . , , . ' i
\:iii::*l' ........ ilvl't '; , , 0,;^: : . ",'ซ( v'1: ........ ': illlii ,'!,.; i"<' ,.'" .:K t1 'i.l .'. ' ' * ': ' -, :,'.'!'.
1' ' "'" "end-use products that contain triclopyr the product labeling must
f^iv '*$ l;'-^eil^?e4 1? ^4ฐ?^ me entry restrictions set forth in this section. Any conflicting entry restrictions
ifiiiiiii'*"' ........... T'i '.; .S1':1!" .' ' iicv1 ;i1"'" ""'l|i: '' ..... ' ''iV i ...... ....... l~ .................. ,'T .......... "" ................. , .............. " ........... ................................. ................ "
on the current labeling must be removed.
'-- ' iij '- ' -For multiple-active-ingredient end-use products that contain triclopyr the entry restrictions
set forth in this section must be compared to the entry restrictions on the current labeling and the
more protective must be retained. A specific time period in hours or days is considered more
protective than "sprays have dried" or "dusts have settled." " _ :
III i
i!
124
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Products Intended Primarily for Occupational Use
WPS Uses . .- -. ' - - ."
Restricted-entry interval:
A 48-hour restricted-entry interval (REI) is required for uses within the scope of the WPS on
all triclopyr TEA end-use products.
A 12-hour restricted-entry interval (REI) is required for uses within the scope of the WPS
on all triclopyr BEE end-use products.
Early-entry personal protective equipment (PPE):
The PPE required for early entry is:
coveralls, . .
chemical-resistant gloves, : '
shoes plus socks, and
protective eyewear.
Placement in labeling:
The REI must be inserted into the standardized REI statement required by Supplement Three
of PR Notice 93-7. The PPE required for early entry must be inserted into the standardized
early-entry PPE statement required by Supplement Three of PR Notice 93-7.
NonWPS uses ' ' . . . ; . . - '
Entry restrictions:
The Agency is establishing the following entry restrictions for nonWPS occupational uses
of triclopyr end-use products: , ''
. For liquid applications:
"Do not enter or allow others to enter the treated area until sprays have dried."
- " *
For dry applications:
"Do not enter or allow others to enter the treated area until dusts have settled."
125
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Placement in labeling:
If WPS uses are also on label Follow the instructions in PR Notice 93-7 for establishing a
Mon-Agricultural Use Requirements box, and place the appropriate nonWPS entry restrictions
-.' in that box. ' :
,^!ll |; ;,;,; ;;|| no^PS us5es are on the label, Place, the .appropriate nonWPS entry restrictions in the
I'lqi/iiBI'i ซ.[., i/ifi " "n.if i n. ' aiiiy i1"* * ,i.i iihiiiiiiiiiiiiiiiir i.;|:iii : ii'iiii, i,., n1. ' n i ;i iซ! rrsM1 / '."Si. mil vsi" a "is'iiin.. FJ ,.!.ซ iu~ ,ปซ-.ป, ,.,. 'in, i' , ,,,:i., , I,, ,.
Illis;! ''iW* i, ";,:' ;Directions,fbr,Use, under the heading "Entry Restrictions."
I'miiiiB ;';.'ซ,;;'!tis tuiii- .,:": iBui!, *ii i-\ut \":t ' ':" ifiiiiit i, ] ...i*.aiiiji .,,. '' ;." . ,a iy ,::.; ti<.,i".j:wr:.Ml'iM,lr ',"ซ" 'IAT. >L, vy i>\i K:1.,* ;. irn.i
Products Intended Primarily for Homeowner Use
JEntry restrictions:
The Agency is establishing tlie following entry restrictions for all homeowner uses of
triclopyr end-use products:
a ll. , . . .
For liquid applications:
"Do not allow people or pets to enter the treated area until sprays have dried."
For dry applications:
"Do not allow people or pets to enter the treated area until dusts have settled. "
Slliil'i 'vi ;' 'I'1 i":1' ;l"l' "" i: I inngiii ' 1 1 ii II i ' * _','',' : , i ! ' ,',
Placement in labeling:
Place the appropriate entry restrictions in the Directions for Use, under the heading
................ ....... ' ...... ......... ..... " ' ...... ' ................................. """' ............ ' ........ ........ ' ........ '
.'Jit'l "'" iglf1,i i,y;iflr!;i'' '; i'v 11|| , .
""ii";!'" ,.' . i " ''If '"' ซ:-'" 'II '
Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be located on all end-use products
containing triclopyr that are intended primarily for occupational use.
Application TRestrictions
i i " I I! I i i i "i i i i i i . r ,.;. i ,.'
"Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may be in the area during
application."
126"
,". ';, :,' ,;ii sill uiu i,i iniiiii; i: i : ; /Mir .11 i -, '! '',::::;,; ' >::;: ~ "",!', ,:,;
-------
Engineering Controls
"When handlers use closed systems, enclosed cabs, or aircraft in a.manner that meets
the requirements listed in the Worker Protection Standard (WPS) for agricultural
pesticides (40 'CFR 170,240(d)(4-6), the handler PPE requirements may be reduced
or modified as specified in the WPS."
User Safety Requirements
I- -.,.' ,. - '" '
1. Registrants: place the following user-safety requirement on the labeling only if coveralls are
required for pesticide handlers on the end-use product label:
. "Discard clothing or other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."
2. Registrants: place the following user-safety requirement on the labeling always:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions
for washables are given, use detergent and hot water. Keep and wash PPE separately
from other laundry."
User Safety Recommendations
a "Users should wash hands before eating, drinking, chewing gum, using tobacco,
or using the toilet" -i -
ป "Users should remove clotliing immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing." -
H ! "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."
Skin Sensitizer Statement
"This product may cause skin sensitization reactions in some people,"
' \_
127
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llilJ1 III!!1'!,,,,!1'1 i ill! !'
Mli
1IIU ,11111'""!l i "liJl'li
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Products Intended Primarily for Home Use
Application Restrictions
w i i M :i|! I ill I i I I ' ' . , .
"Avoid contact with eyes, .skin, or clothing during and after application."
"Do not apply this product in a way that will contact any person or pet, either directly
or through drift. Keep people and pets out of the area during application."
User Safely Recommendations
ป "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."
Registrants: place the following user-safety recommendation on the labeling only if gloves
and/or protective eyewear are required for homeowner users:
" "Users should remove protective clothing and equipment immediately after
handling this product. Wash the outside of gloves before removing. Keep and
wash protective clothing and equipment separately from other laundry."
"'
Skin Sensitizer Statement
,, ;
MThis product may cause skin sensitization reactions in some people."
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 applicator. The
interaction of many equipment and weather related factors determine the potential for
spray drift. The applicator and the grower are responsible for considering all these
factors when making decisions.
The following drift management requirements must be followed to avoid off-target
drift movement from aerial applications to agricultural rice patties.
128
"S: !"..',';.; 'Ml';,
-------
1. The, distance of the .outer most nozzles on the boom must not exceed 3/4 the
length of the wirigspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never be
pointed downwards more than 45 degrees.
Where states have more stringent regulations, they shall be observed.
The applicator should be familiar with and take into account the information covered
in the Aerial Drift Reduction Advisory Information'.
INFORMATION ON DROPLET SIZE
The most effective way to reduce'drift potential is to apply large droplets. The best
drift management strategy is to apply the largest droplets that provide sufficient
coverage and control. Applying larger droplets reduces drift potential, but will not
prevent drift if applications are made improperly, or under unfavorable environmental
conditions (see Wind, Temperature and Humidity, and Temperature inversions).
CONTROLLING DROPLET SIZE
ซ Volume - Use high flow rate nozzles to apply the highest practical spray
volume. Nozzles with higher rated flows produce larger droplets. (
ซ Pressure - Do not exceed the nozzle manufacturer's recommended pressures.
For many nozzle types lower pressure produces larger droplets. When higher flow
rates are needed, use higher flow rate nozzles instead of increasing pressure.
Number of nozzles - Use the minimum number of nozzles that provide uniform
ซ Nozzle Orientation - Orienting nozzles so that the spray is released parallel to
the airstream produces larger droplets than other orientations and is the recommended
practice. Significant defection from horizontal will reduce droplet size and increase
drift potential^
^ ' " " i '
ฎ Nozzle Type - Use a nozzle type that is designed for the intended application.
. With most nozzle types, narrower spray angles produce larger droplets. Consider
using low-drift nozzles. Solid stream nozzles oriented straight back produce the
largest droplets and the lowest drift... ,
BOOM LENGTH
, ' 129, . , .
-------
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. IVlaking
applications at the lowest height that is safe reduces exposure of droplets to
", .'."' ' U! ,in , .;.i|! "l.liHIIIIIIIP J ........ ..' ...... J'":" ..... ;'' ..... ' _' ............ '' ................ >T [[[ ..... I ............. ,JT
evaporation and wind.
I III i III I Ml i ii i ..... " ii / .i ..;".. i'.' ' , ; , ',' , ..; ,. \ ' ; I,"';" :;, "> "<*
When applications are made with a crosswind, the swath will be displaced downward.
Therefore, on the up and downwind edges of the field, the applicator must
compensate for this displacement by adjusting the path of the aircraft upwind. Swath
adjustment distance should increase, with increasing drift potential (higher wind,
...... ' 1" ''' '
, ,
i i HIM i
Ml 111 | I
WEND
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.
L " f " "'' ,' ' ' ''
TEMPERATURE AND HUMIDITY
i in i 11 .1111 i .," ji" ..
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
-------
generator. Smoke that layers and moves laterally in a concentrated cloud (under low
; wind conditions) indicates an inversion^ while smoke that moves upward and rapidly
dissipates indicates good vertical air mixing.
; SENSITIVE AREAS ' -
* *
The pesticide should only .be applied when the potential for drift to adjacent sensitive
areas (e.g. residential areas, bodies of water, known habitat for threatened or
endangered species^ non-target crops) is minimal (e.g. when wind is blowing away
from the sensitive areas). " '
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 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 triclopyr 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. .
131
-------
Ill
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132
-------
VLAPPENDICES
133
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PRO Report Date: ' 09/13/95
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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 covered by this Reregistration Eligibility Decision Document, it contains
generic jdata requirements that apply to 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 the}7
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) 605-6000. " '. ; '
i , .
2. Use Pattern (Column 2). This column indicates .the, use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food '
B Terrestrial feed .
C Terrestrial non-food,
D Aquatic food
E :. Aquatic non-food outdoor ' ' .
F Aquatic non-food industrial
G Aquatic non-food residential
H . Greenhouse food , .
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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. -,
175
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' . I- :!. , >j ;,:; ' GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. Thiง ...... bibliography contains ..... citations of all studies '
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
keregistration Higibility Document. Primary sources for studies in this bibliography have been
of data submitted to EPA and its predecessor agencies in support of past regulatory
...... ...... ' :i. '1|lhlปป ............ ''ซ' ..... i. : : ......... ...... :' .......... ...... ป ............ 'ซ' ซ ............ ........... ......... ........... ป ...... '' ....... ............ ........ ...... ....... iwi*a ..... "iiiMi, ....... ....... li "i, i ....... , ..... " MI, .',IINTIM,,IIII, , i ....... ,,MI ....... iki'im ..... 1,1,1, ปT ..... ,,.,,. ' '' ' ..........
have been considered, are included.
" 'i. :i |, VI I!!1'1 "I1 i,i llljPj ป ill "V > " , JHBil ,'' I V ,11 ..... ,il, , , L,JIIL , "jl,1 III, '!" lil^f II. i , .ilii,, T'l1 'I1 71 ' ' pi1 i ''',. .l,!,,1'1!'!!., !,'!'"ซ '" :f ป':,,'!,: i|'i ',!".. 'i1 ,''<>,.; ' j'i'i'.iil i! < , '" I , , ; ' " iป' . ' i , I < i,!< / ',,
^, ...... m m ..... '& lil i1 , i , i ' ..... 'i i mmM ..... mmm m ^^m ..... i:*.;r ..f* ' :: , i ^ "t : ' : ; ;
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
, (1) Submission dateJ The. date of the earliest known submission .appears immediately
following the word "received." -
' (2) Administrative number. The next element immediately following the word "under" is
the registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
J : ^ _ .
(4) Volume Identification (Accession Numbers). The final element in the trailing
.parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn'
followed by an alphabetic suffix which shows the relative position of the study within
the volume.
191
-------
lip'iiiiiii'pi11 .iiirhi in,,,! ipi", < i1,,: flip;" i,,, , iiLUiiiij'a i; ป,', iiei r , ipi1,1
iiiuiip'iiiiv CiJiiiiiii'1 ,"" iiiiiiiii1 'ip'i1'! ' M'V '''I'li ''Mi1:1; v
BIBLIOGRAPHY
CITATION
{.."' > 0021^6,, .'^^CS.-'Hanley, T.R., Jr.; Dabny, B. (1979) Dowco 233: Heritable Translocation
:.. " , '. =1 ..... !,; :'; '=- and" Dominant Lethal Test in the Mpuse^ , ^{iLJnpublished study received M IS, 1 979
sf '[', ซi"\i. '^'!i!^er^4r^|^;^|mttedBypcw ..... Chemical U^S"A.? Midland, Mich:; .....
T^ : =;;;;";; ;i ;:,v"cDL:241822-A) [[[
.' Jili' ""' , lliiDhill!" "I'i1',,1"' "'!'i,i..i' if ป iiii'll'in'N , :!': ll'llll'l'lli' ,,J!!l|!!,l""",',,lil" ,"T i"il'. ..... iป'1ii!ll"! , ! . ,li I '"liliill ' ','"'i
twin''.?. ..... , ..... vJiw ...... .1 0003 1249_ Beavers, IB.; FinR Brown, K-etal.' (1979) ina Report:" Eight-Day Dietary
f SJii ;'^;' ||' ;!.;':' 11 ;1^'S)^Q^93ii??to4^; ....... ฃf fป)ec!,,No. ....... 1 03-1 193 . (Unpublished study received -Apr 29,
:;;;;, ....... ;;;;;;',:::;:;; ......... ;, , ,. ,;:, ..... , , /, ;;;,. 1980 under 464-546; prepared by Wildlife International, Ltd. in cooperation with
fEl'':;i^; ::" '";:; ::; ;' ' :::; i1 '. ;:, ' ; ..... ,; .i: : .;:WasWngton College^ ^submitted by Dow^ Chemical' US A!',' 'Midland, 'Mich. ; CDL:
' " " ' ' ....... ' " ........... ; ..... " ....... ..... " ..... ' " ' " " ......... ..... " ' ..... ...... ....... ........ ...... ...... ' ' ' ' ' ' "
"K^IRIIii'll ij'iii!1 I1!, V'i ";1 iii'iil"' " ' ' ii'ltW." '!'i"ปi l! i''.1'"'11' '" " 'ป l|i!|1""iป'1 'll1'" 'i" iilHilllfil! ' ซ : ..... I!.' ..... , \, ":','' ill "tr ;! fl1 ifil'. I ',ป' ' "'! '.rll'". "V,' , '" ..J1 ,::"!!' H "M ....... :.;i|,",..i ''.''", ,' .'"I S'lJlii,1 'liT'l'liA"'1!!"1"'!. fiP1 ', , flilW HII!" ." , . l,,,''i. ,'! 'i "i1 "'I, :.,",' :( ' '
0003 1250 Beavers, J.B.; Fink, R.; Grimes, I; et al. (1980) Final Report: One-Generation
~;'^":f .^ "',;.;;:1:' \ ' ';.' ;*;;;';"; ;"; ;;,'';;l\]R^roduction' Study~MaJiard""Duck: 'Project No. "l 03-1 92"^ ..... (Unpublished study
~ฎ:ij ......... '*:: ...... - ...... ' ' ": " : ;"" '^'''riaeivel Apr 29, 1980 under 464-546; prepared by Wildlife International, Ltd.,
submitted by Dow Chemical U.S A., Midland, Mich.; CDL:242368-C)
"'*'''< ...... ;:;:;:;" ;; ......... 0003 1251 ........ Beaveirej'1IBl;llFink,R!;lllGnmes, iVeVal'.' (1979) ;pmai Report: dne-Generation
l"";,'!^?''''^' "ji , ''t1':''.r:^-'.Kepro3uction Study~Bobwhite Quaih Project No. 103-191. (Unpublished study
"'" .............. ' ............. ! ' ..... ..... " ....... ' ..... ! received Apr 29, 1 980 under 434-546; prepared by Wildlife International, Ltd.,
........... " ......... ' ..... '"'' ..... J ..... :r" ";' ......... "" ": ' ...... submitted by Dowdhemic^UlA^M ......... .
0003 1939 Richold, M.; Jones, E.; Proudlock, RJ. (1979) Ames Metabolic Activation Test To
. ~: .. Assess the Potential Mutagenic Effect of Dowco 233: DWC3 16/791 014.
(Unpublished study received Apr 29, 1980'under 464.545. prepared by Huntingdon
Research Centre, submitted by Dow Chemical U.S.A., Midland, Mich.;
, :::;:,;: ...... CDL;242367-D)
0003 1 940 Henck, J.W.; New, M. A.; Johnson, K. A. (1 979) Acute Oral Toxichy of Triclopyr.
:::: '!' '';:':' (Unpublished study received Apr 29, 1980 under 464-546; submitted by Dow
. Zi\ i. ' ;:!"Vi;Chemi,cal U.S A., Midland, Mich.; CDL:242367-E) "
IFIH >i;!li
00038408 Shirasu, Y.; Moriya, M.; Watanabe, K. (1978) Report of Mutagenicity Test on
5 Triclopyr in Bacterial Test System. (Unpublished study including Japanese text,
received Apr 29, 1980 under 464-546; prepared by Institute of Environmental
5.: '-I Toxicology, Japan, submitted by Dow Chemical U.S.A., Midland, Mich.;
"iii; " 'linCDL:2423'67-C)
-------
BIBLIOGRAPHY
MRID
CITATION
00049637 Batchelder, T.L. (1973) Acute Fish Toxicity of Dowco 233 '
/ (3,5,6Trichlorp-2-pyridyloxyacetic acid) and Two Derivitives 0sicj: Report
WCL73014. (Unpublished study received Feb 26, 1974 under unknown admin, no.;
. submitted by Dow Chemical U.S.A.; Midland, Mich.; CPL:222240-E)
00049638 Norris, J.M. (1973) Eight Day Dietary Studies .on Dowco 233 in the Mallard Duck
and Japanese Quail., (Unpublished study received Feb 26, 1974 under unknown
, . . admin, no.; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:222240-F)
00056009 Olson, K.J. (1967) lexicological Properties of 3,5,6-Trichloro-2pyridyloxy acetic
acid. (Unpublished study.received Feb 26, 1974 under unknown admin, no.; .'
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:222240-D)
00056010 Andriessen, F.G. (1973) Dowco-(R)a3 290, Dowco 286 and Dowco 233-Persistence
in Soil and Effect on Wheat. (Unpublished study received Feb 26, 1974 under
unknown admin, no.; submitted by Dow Chemical US A., Midland, Mich.;
CDL:222240-H) - '
00057085 Sibinovic, K.H. (1973) In vitro and Subacute in vivo Host-Mediated Assay for
Mutagenesis: Compound Dowco 233: LBI Project No. 2421. Final rept.
. (Unpublished study received M.ay 10, 1977 under 464546; prepared by Litton
Bionetics, Inc., submitted by Dow Chemical U.S.A, Midland, Mich.; CDL:229780-G)
00057086. Fabrizio, D.P.A. (1973) Acute and Subacute in vivo Cytogenetic Study in Rats:
Compound Dowco 233: LBI Project No. 2421. Final rept. (Unpublished study
received May 10, 1977 under 464-546; prepared by Litton Bionetics, Inc., submitted
.by Dow Chemical U.S.A., Midland, Mich.; CDL:229780-H)
00057087 Fabrizio, D.P.A. (1973) Dominant Lethal Assay for Mutagenesis: Compound Dowco
23 3: LBI Prqj ect No. 2421. Final rept (Unpublished study received May 10, 1977
under 464-546; prepared by Litton Bionetics, Inc., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:229780-I) .,.'',
00062623 Heitmuller, T. (1975) Acute Toxicity of M-3724 to Larvae of the Eastern Oyster
(-Crassostrea virginica-), Pink Shrimp (-Penaeus duorarun-), and Fiddler Crabs
(~Uca pugilator). (Unpublished study received Nov 4, 1975 under 464-EX-46;
prepared by Bionomics, EG&G, Inc., submitted by Dow Chemical U.S.A., Midland,
Mich.;CDL:233134-H) ' ,
193
-------
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..... -*
, BIBLIOGRAPHY ,"
iiiiii ........ 'iiiME ........ iiiitji: i'iiij.r.i <<* :t > i. :, <"!ป i : ...... rait i i i i i i i in i i , .'. .: > : '.'"'i* i :">ป r-..1 ::'-\;,-t\
CITATION
.
'i j11";1*;!'1,,,!, 'i w1.. ..... i'""',i iiiiii - ..... 4 .......... i11;.,'. 'Si*1 .1 I Iiiiii i i i i i i 11 i i i1 ', " *" ..... <.., , ''V , ,'i ..... i",!,!1,;.1 jj',,1/
||;;'1g
^ir?-'";i:"r-:i.'''3ป5,6Trichloro-2-pyridyioxyacetic Acid (Dowco 233 Herbicide): Subchronic Dietary
Feeding Study in Beagle Dogs. (Unpublished study received May 1, 1981 under
id by Dow'Chemcal'y^S.A.', MilandjMich.;lCDL:070043-C)
!:!3:ซป
,'" 'I1'1 , iilW1 'liiB1'1! "...I, '!!!' !!"!!' 'I1 iifl!!!ii!, ,:' M1 IJilllllllll ' i1
::::::,::: ^ 00071794 _ Quast, IF.;. Wade, C.E.; KalnmsAR.V.j etaL
, 33j6-Tiichloro-2-pyridinyioxyacetic Acid (Dowco 233 Herbicide): Supplemental
ilSli.vS'i ".'.S'i'i'-'.^T/i'SMb.ehiConi.Q Dietary Feeding Study in Beagle Dogs. (Unpublished study received May
^f!; SS ;:;; - fii1 '.1:,'^$;!' !*, 19?,1 und61" 464-554' submitted by Dow Chemical U.S.A., Midland, Mich.;
iiiii ..... rsi. ' , wii1'1 'rt. ' f" i: i" M: :, 'i ปv MI...":
R.D. (1977) Determination of Residues of 2-Methoxy-3,5,6-trichloropyridine in
1 !6?
Dow
!:,!!! ;;* , ,, ' , IIEil,i!:!' "!, >.
lll'il!' ["ilUiLli!:.'"' I'luiimll
00071803 McKellar, R.L. (1977) Determination of Triclopyr,
iiij1 iiiiiiivji1..,, ,., M !*!' , 'i ,i llli||l|iril "'i1..,'1' * ' iii1'!1 ill !" i |i '",!>":: oi'ni ii' jijPiil'iiliii; ,'i, i\vซ K.fin.iiLl1'!1 Ji.nril'l1:,,'. wi'iiA '"iinini i'i|i.|n ui.i i"ii, H iii'i MVII M oi.'.iiir, iv, ซ inii: ,1,111;-ir: . .UN ^i,ri,Mjiiirป, ., ., c, , , i ,,, ,. . ,,.,.. ,, ,.-,',,,
;;fffi^tif Yi'"" lli.ifi!;'''1.f-Sf:((3,5,6-Trichloro-2-pyridinyl)oxyacetic Acid); 3,5,6-Trichloropyridine in Grass by
Gas Chromatography. Method ACR 77.4 dated Mar 25, 1977. (Unpublished study
received May 1, 1981 under 464-554; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:070045-D)
00071805 Yackoyich, P.R; Bauriedel, W.R. (1976) Fate C14-Triclopyr Fed to Lactating Goats.
(Unpublished study received May 1, 1981 under 464-554; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:070045-F)
iiiimi1:1 I'liWLiiii1,,,, 'IE,11!!;!,; '!', ] mill 11 i in i i i n ,':" "",ป ซ ,.,,, ', , . ,,i,, .J1,,1 ,^\s.
00071806 Glas, R.D. (1977) Residues of Triclopyr, 3,5,6-Trichloro-2-pyridinol and
2-Methoxy-3.>5,6-trichloropyridine in Bovine Tissues from Calves Fed Triclopyr.
(Unpublished study receivedMay 1, 1981 under 464-554; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:070046-A)
00071808 Glas, RD. (1977) Residues of Triclopyr, 3,5,6-Trichloro-2-pyridinol and
2-Met|ipxy-3,5J6-trichloropyridine in Milk and Cream from Cows Fed triclopr.
(Unpublished study received May 1, 1981 under 464-554; submitted by Dow
Chemical U,S.A, Midland, Mich.; CDL:070046-C)
00071810 Mcl^e|ar, R.L. (1972)petermination of Residues of 3,5,6-Trichloro2-pyridinol in
"::"'; "- /Swne^issues*byGas'"Cnromato^ Melhocl ACR 72.2 dated Jan 10, 1972.
;ซii:: ,:;! ; ::,, "i ..i ..; , ,ซ i ,;,'ป, ,,,!,,,
'.";:.-" '^-.^f. "" " 194
Iri'jiii: I 'iSi: ," ,;,i',J,!I'
iilVIliiL'! I'i;,!HE'11:1- s ,'ปป "
siiu ',|, :n 11111111:11 ,,\K in i \u.
-------
BIBLIOGRAPHY
MRID
CITATION
, (Unpublished study received May 1, 1981 under 464-554; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:070046-F)
~00071811 Glas, R.D. (1977) Determination of Residues of (3,5,6-Trichloro-2
pyridinyl)oxyacetic Acid in Bovine Milk, Cream, Muscle, Liver, Kidney, and Fat by
Electron Capture Gas Chromatography. Method ACR 77.2 dated Jan 31,1977.
(Unpublished study received May 1, 1981.under 464-554; submitted, by Dow Cheical
U:S.A, Midland, Mich.; CDL:070046-G) . ,
00071812 Glas, R.D. (1977) Determination of Residues of 2-Methoxy-3,5,6-trichioro-pyridine
- in Milk and Cream by Electron Capture Gas Chromatography. Method ACR 77.8
. - ' " dated Aug 26, 1977, (Unpublished study received May 1,; 1981 under 464-554;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL.-070046-H)
00071813 Glas, R.D.(1977) Determination of Residues of 2-Methoxy-3^5,6-trichloro-pyridine
in Bovine Tissues by Electron Capture Gas Chromatography. Method ACR 77:11
dated Aug 25, 1.977. (Unpublished study received May 1, 1981 under 464-554;
submitted by Dow Chemical U.SA.i Midland, Mich.; CDL:070046-I)
- . ' . .1
00071814 McKellar, R.L. (1971) Determination of Residues of 3,5>Trichloro2:pyridmol in
Milk and Cream by Gas Chromatography. Method ACR 71.2 dated Feb 2,1971.
(Unpublished study received May 1, 1981 under 464-554; submitted by Dow
"';. Chemical U.S A., Midland,Mich.; CDL:070046-J)
00072443 Meilde, R.W. (1976) Metabolism of 3,5,6-Trichloro-2-pyridinyloxyacetic Acid
. (Triclopyr) in Grass and Soil: GS-1442. (Unpublished study received May 1, 1981
under 464-554; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:070044-I).
00127280 Bauriedel,W.; Tarr, J'. (1983) The Metabolic Fate of l,4C-triclopyr Fed to a Lactating
Goat. (Unpublished study received Apr 12, 1983 under 464-554; submitted by Dow
Chemical U.S.A., Midland, MI; CDL:071512-A)
00134173 McKellar, R. (1977) Residues of Triclopyr, 3,5,6-Trichloro-2-pyridinol and
2-Methoxy-3,5,6-trichioropyridine in Grass Treated with GARLON 3A Herbicide:
.GH-C 984. (Unpublished study received M 6, 1979 under 464-546; submitted by
Dow Chemical U.S.A., Midland, MI; CDL:238833-A)
195
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jjj||,;,;,;,,; ;;: ^p,:,,(,iirfi'r.,,,;,,:(Oti'.*,';;;;;: ;'.,;; ,; ' ;|j^;;i.;^. 'UiWJuIOGRA^HY (.f| . , j;,,,, ,, |
iii
lll: ' ' ' "1'^A>m CITATION
".Ml1"'HI i'!' W , I ' I'l'iUni'tH: i! "I!1 "'.i "i,|i' lir,,1'!!1:11!1:!:.,..1**11,"!,11",,!,'1!1 iliM.'!,,!:1 Hi,.,"': "i. " ''i.'i.! . ,! ill'.'ill,.1 ".n1
00134174 Bidlacjc, H. (1978) The Hydrolysis of'Triclppyr EB Ester in Buffered Deionized
Water Natural Water and Selected Soils: (jf^c 1106, .(Unpublished study received
Nov 13, 1979 imder 464-554; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:241362-A)
00134179 Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-Mallard Duck:
Triclopyr-ethylene Glycol Butyl Ether Ester: Project No" 103-173, Final rept.
(Unpublished study received Nov 13, 1979 under 464-554; prepared by Wildlife
International Ltd. and Washington College, submitted by Dow Chemical U.S.A.,
s\v'''^^^Si^'^^^^-^
iii:lT!fiLjiii!;i| i:i 00)34180 Fink, JL; Beavers, I; Brown, R.Q^^^^^Di^zryt LC50-Bobwhite Quail:
1 Tric^p^r-elSyie^ Final rept.
, '(unpublisneH' studf^"recaved Nov" 13,' 1979 under 464-554; prepared by Wildlife
International Ltd. and Washington College, submitted by Dow Chemical U.S.A.,
l:llllll!Mlllllllilll!!^ill' hi1 is^ioCi v iซ;fe, 'l|l>1'". i iiDiiM1
00134181 McCarly, W.; Alexander, H. (1978) Toxicity of Tiidbpyr, Ethylene Glycol Butyl
Ether Ester to Freshwater Organisms. (Unpublished study received Nov 13, 1979
under 464-554; submitted by Dow Chemical U.S.A., Midland, MI; CDL:241360-E)
00150378 Landry T.; Eisenbrandi D.; Gushow, f. (1984)""fndopyrl 13-week Dietary Toxicity
in Fischer 344 Rats. Unpublished study prepared by Dow Chemical U.S.A. 274 p.
00151956 McCarty, W.; Alexander, H. (1978) Toxicity of Triclopyr, Triethylamine Salt to
Freshwater Organisms: ES-199. Unpublished study prepared by Environmental
Research Lab., Dow Chemical U.S.A. 14 p.
00151958 Jvlayes, M.; Dill, D.; Mandoza, C,; etal. (1983) The Acute and Chronic Toxicity of
Triclpgvr Triethylaminei Salt Solulion to Fathead M^ Unpublished
study prepared by Environment Sciences Research, Dow Chemical U.S.A. 18 p.
|l ll1! i ' i l iinilil MI l i I - .
ill I'l1 li ' 'i11 i i in ll 'i ' II ":':;'_'
00^51959 Gersich F.; Mandoza, C.; Hopkins, D.; et al. (1982) The Acute and Chronic Toxicity
of Tricjppyr Triethylamine Salt Solution to Daphnia magna Straus: ES-583.
Unpublished study prepared by Environmental Sciences Research, Dow Chemical
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00153805 Van Beek, L.; Leegwater, D. (1981) Study on the Percutaneous Absorption of
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00153807 Van Beek, L.; Leegwater, D. (1981) Study on the Percutaneous Absorption of
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00154713 Bidlack, H.; Laskowski, D.;Swann, R.; et al. (1977) Comparison of the Degradation
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Unscheduled DNA Synthesis Assay: Laboratory Project ID; HET K-0420.85-031.
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40107701 Eisenbrandt, D.; Firchau, H.; Wolfe, E,; et al. (1987) Triclopyr: 2-year Dietary .
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1094 p.
40346304 Bidlack, H.; Laskowski, D.: Swann, R; et al. (1977) Comparison of the' ,
Degradation Rates and Decomposition Products of Carbon-14 Triclopyr in Aerobic
and Waterlogged Soil. Unpublished study prepared by Dow Chemical USA. 37 p.
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Ill III
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403,46401 Wjldlffe International Ltd. (1976) Acute Oral LD50~Mallard Duck Triclopyr
technical Final Report: Project No. 103-156. Unpublished study, lip.
Sfi&oซ.' ti'f ' '^^^^^^^M&^^^kW^), งiงtoRay Pietary LC50--Bฐbwhite Quail Triclopyr'
||||ii|%;|',f;' ; Kjit;:;; ""j$.|::|lPtaHBpB,'&ฐr!: 1^9^&:. I9l-l^;',ynpublished study, 'lip.
' " "' ',! "" | ' ' "!'' s "' T' ' ' ''' , ' * ' '" '" . '"* ' "' ' " i"''' '
'2.;;*;;' ;;;':*;;;;40346501 Wildlife MernatipnaJ^Lid, (1978) Acute Oral^LDSO-Mallard Duck
"' '' " ' ! "' '"* :ii::":' ':ii l"li"::' '"' ;'';iLl'ii!:iTncl6pyr-Tnemyiamme Salt: Final"Report:"Project No'. 103-174. Unpublished study'
?ฃ?; ';- "f-:;- *< ?*ซ'< 14 p. ^ .' - .
40346502 Wildlife International Ltd. .(1977) Eight-day Dietary LC50-Mallard Duck,
THclopyr-triemylamine Salt: Final Report: Project No'.'103-171. Unpublished study
40346503 Wildlife International Ltd. (1977) Eight-day Dietary LC50-Bobehitw [sic] Quail
SJEpi :i:S'!:!,:;;::!: :;:' ' ' Trfclopyr-TrieAylamine Salt: Final Report: Project No. 103-170. Unpublished study.
14 p.
40346504 McCarty, W.; Batchelder, T. (1977) Toxiciry of Triclopyr to Daphnids. Unpublished
,, ,,, ,,, if fi, , i ,:, stedy prepared by Dow Chemical. 8 p.
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^.MiiiS^'if.'; '. siiii '\ :;':^i;^FP^X,a!!^ O"ncฐง5ni^ty Study in^Mice. Unpublished study prepared by The
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., :'"::'-: :.;,:; ,; , |:;:;i;,:; ;rr;,;:P,^[ Ijpal Report: Laboratory Project ID 103-239.' Unpublished study prepared by
(_ ,i,=;--'!;i,;j|: :i;:,;;:;:,';:,i^Mi|eirIntemational, Ltd. 14 p.
40356606 iHamburg, A.; Yackovich, P.; Almond, B. (1987) The Metabolism of Carbon-14
^;:Tricipgyr in Laying Hens: Dow Laboratory Project ID GH-C-1908: ABC Laboratory
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40356607 Yackovich, P.; Lardie, T.; Miller, J.; et al. (1987) Characterization of Radioactivity in,
Rotational Crops Planted 36 and 154 Days Following Soil Treatment with Carbon
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I,1, i III i1 i' < |
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40440702 Hopkins, D. (1987) ((3,5,6-Trichloro-2-pyridinyl)oxy)acetic Acid Triethylamine Salt:
Determination of the Water Solubility: Laboratory Project ID: ES-DR-0114-8261-1.
Unpublished study prepared by Dow Chemical Co. 14 p.
40473601 Chakrabarti, A.; Germrich, S. (1.987) Vapor Pressure of Triclopyrbutoxy ethyl Ester:
Laboratory Project ID: ML-AL 87-40043. Unpublished study prepared by Dow
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40479101 Cranor, W, (1987) Aerobic Aquatic Metabolism of Carbon 14-Triclopyr: 35651.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 48 p.
40557001 The Dow Chemical Co. (1988) Triclopyr Butoxyethyl Ester: -Product'Identity and
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Certification of Product Ingredients. Unpublished compilation. 18 p.
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, Characteristics. Unpublished study. 6 p.
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Oral Toxicity Study in Fischer 344 Rats: Laboratory Project Study ID:
K-120085-006A. Unpublished study prepared by The Dow Chemical Co. 34 p.
40557005 Wall, 1; Battjes, J.; Zimmer, M. (1987).Triclopyr Butoxyethyl Ester, Technical:
Acute Dermal Toxicity in New Zealand White Rabbits: Laboratory Project Study ID:
K-120085-006D. Unpublished study prepared by The Dow Chemical Co. 17 p.
40557006 Streeter, C.; Battjes, J'.; Yano, B. (1987) Triclopyr Butoxyethyl Ester, Technical:
Inhalation Study in Fischer 344 Rats: Laboratory Project Study ID: K-120085-007.
Unpublished study prepared by The Dow Chemical Co. 22 p.
40557007 Wall, J,. (1987) Triclopyr Butoxyethyl Ester, Technical: Primary Eye Irritation Study
in New Zealand White Rabbits: Laboratory Project Study ID: K-120085-006C.
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40557008 Wall, J. (1987) Triclopyr Butoxyethyl Ester, Technical: Primary Dermal Irritation
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40557009 Wall, J. (1987) Triclopyr Butoxyethyl Ester, Technical: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Laboratory Project Study ID:
K-120085-006E Unpublished study prepared by The Dow Chemical Co. 13 p.
40557101 DowChemicdCa ฃ?88) Tnciopyr ^X1 ?ster^ Pro^ct Identity ^d Composition.
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40564901 The Dow Chemical Co. (1988) Triclopyr Triethylamine Salt Solution: Product
Identity and Composition. Unpublished compilation. 21 p.
40749801 Woodburn, K.; Fontaine, D.; Richards, J. (1988) A Soil Adsorption/ Desorption
1 Study of Triclopyr: Project ID: GHC-2017. Unpublished study prepared by Dow
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41019702 McCoy, K.; Gegel, B.; Schriber, C. (1988) Solubility of Triclopyr Butoxyethyl Ester
,. j;;;*;;' *ป*...' ซ,];.': '^in Organic Solvents: Project ID: GH-C 2131. Unpublished study prepared by Dow
i^S^lS iiM';; l;"'!''!;^ .......
jj* f J.! f ;;' ^Kfaid?, mj, R!; Swayze, K. (1989) ^ Solubility of ^Triclopy'rTriethylamine^ Salt in Organic " '.
"iJSC^fiv;'1'!1* ".': pi';-""'!": : \'':f''^^.&^::l^^tp^PTO^ectlD: GH-C 2155. Unpublished study prepared by Dow
I|JI ";f'' *''"' 'if!;1 ', ' *!!|i' |"'!':': ';; Chemical' USA!" 15 p!' ''
"i1, | ' 'lip1 ,j, J1 ,,"1',', ;" "1||!;'|i,'ii!i,,,, V fllllllf 'I1'.!'!:, '" '" ''''.'!ill iil, i.":;1"' ,'*,i,:!".i i i,, '..i,.,.'/i . ,' ., .,!,,,L , ปป,,,!",'. |. 'i1'1 -ป ,,i' . ' >. i
fctliJiU.]! :; :4!|bo3pl"'"'^ (^^^.;^ij^ow^^iงtott, w'-_'et d.X^Ssff ricippyr'A One Year Dietary
::,;,,::::: ;;::; :::; :,, , . ;: Tpxicjjy .Study^ in Beagle Dogs: Project Study ID's: K-042085-036; K-042085-36F.
i"'"! """''"!.:' *' ."" .' SI:':, ': '", Unpublished study prepared by JDow Chemicai| Co. 216 p.
41219101 Bailey, R.; Hopkins, D. (1987) ((3,5,6-Trichloro-2-pyridinyl)oxy) acetic acid,
f;!;" ; ;;" triethylamnme Salt Octahol/Water Partition Coefficient: Project ID:
ipfffiliriV!.^ ' 1* j:h'' '.\'",,E|-p||:0,|i,14^2i61p2,:v:iynpublished study^prepared by Dow Chemical Co.' 18 p.
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=i;.!::': t. :*';: -.;,: ;,:;:i ' j ": ' ,'" :\ of Tricippyr TEA Salt by the Knudsen-Effusion/ Weight Loss Method:' Prpj ect ID:
L ง8-020173. ^published studyprepared by Dow Chemical! lip.
J; ,'Hi,!. | ' , .I.Hlii!;. 1 r'H'l Jl1 I1 '
ii ,M."l',ii,.; ,!>" liniiiihi lib : u
;; 200
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41219108 Yackovich, P.; Lardie, T.; Miller, J. (1988) Determination of Radioactivity in
Rotational Crops Planted One Year Following Soil Treatment with carbon
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Dermal Toxicity Study in New Zealand White Rabbits: Lab Project Number:
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41443303 Nitschke, K.; Battjes, J.; Yano, B. (1989) XRM-3724: Acute Aerosol LC50 Study in
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P-" ' '..'. . .:'. ''.-'
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41688301 Breslin, W: (1990) Results of a Teratology Study on DOWCO 233 in the Rat: Lab
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417343 01 Weseloh, J.; Stockdale, G. (1990) A Study to Determine the Effects of Tricl opyr on
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" - ' . i ' ' '
41734303 Krause, R. (1990) Compatibility of Construction Materials Triclopyr EB Ester .
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41736302 Cowgill, U.; Milazzo, D.; Landenberger, B. (1988) A Comparison of the Effect of
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203
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till illE ',1, f- i IS "")> 111!"
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, , ,, .
CITATION
4l73g304
":!, Illllii1!!1'; 'fl
,<|i ;' ": IH/.,,;" ' in ' wiilitl!
I ,1, I1" ', ,1 I In!'' i'llJI'l ''ll'l'll'' '.IS* ป
es, ^'Wtoplij^ P-'i'eV'aL; (iฃ89)"JPhamacokinetics And Metabolism
of nclopyr Butoxyetliyi Ester In Coho Salmon: Lab l?roject Number:
ES-DR-0133-7242-5: ES-1082. Unpublished Study prepared by The Dow Chemical
Co. 31 p.
I'! !!":. I1' AlnilliTI'i'l, Ji
lllll!!ll|||l!P'!i,il!iii " in ililii 'i
4!747i6l
"" 111!,! I Vfl'.'(::"*i:
lllป^ 1!;.!l|i;i;'i"f
nil1 Dili! mill' i:ii'"'!'i:,i,, mil1: ! M/W
illi' , llllilj"1 ,' lllf!11,i i,,"1 , i,!, "I
Gollapudi, B.; Samson, Y. (1990) Evaluation of Triclopyr Butoxyethyl Ester
(Triclopyr BEE) in the Mouse Bone Marrow Micronucleus Test: Lab Project
Number: K-120085-009. Unpublished study by The Dow Chemical Co./Lake
Jackson Research Center. 30 p.
1 IS ' ,1" ' f III I III 11 II 1
MllS'f'i i1 "'SH1!:1!1'!":,
iiNi
4|747102 ggUapudi, B. (1990) Evaluation of Triclopyr Butoxyethyl Ester (Triclopyr BEE) in
il; i ;; i:; : Ijhe Rat Hepatocyte Unscheduled DNA Synthesis ฃuDS) Assay: Lab Project Number:
K-120085-008. Unpublished study prepared by The Dow Chemical Co./Lake
Jackson Research Center. 48 p.
ift.il IK:, I ,[.
i1 BB1!1 !f:! ' "'-.
41879601 Cleveland, C.; Holbroolc, D. (1991) A Hydrolysis Study of Triclopyr: Lab Project
,. sl';^1;^;^'' Mumber: ENV91023. Unpublished study prepared by DowElanco, North American
Environ."Chem! "Labi 40 p.
41902002 Campbell, S.; Lynn,S. (1991)' Triclopyr Bee: An Acute Oral Toxicity Study With the
Northern Bobwhite: Lab Project Number: ES-DRO133-7242-9. Unpublished study
prepared by Dow Chemical Co. 25 p.
41902003 Campbell,S.; Lynn,S. (1991) Garlon 4 Herbicide: An Acute Oral Toxicity Study With
the Northern Bobwhite: Lab Project Number: ESDR-0224-6186-8. Unpublished
study prepared by Wildlife International LTD. 22 p.
41905501 Lynn, G.; Smith, G.; Grimes, J. (1991) Triclopyr Bee: A Dietary LC50 Study with the
Northern Bobwhite: Lab Project Number: ES-bR-0133-7242-10. Unpublished study
prepared by Wildlife International LTD. 22 p.
41905502 Lynn, S.; Smith, G.; Grimes, J. (1991) Triclopyr Bee: A Dietary LC50 Study With the
Mallard: Lab Project No: ES-DR-0133-7242-11. Unpublished study prepared by
Wildlife International LTD. 21 p.
41961001 DixpnrWhite, H. (1990) Residues of Triclopyr, 3>5,6-Trichloro-2-pyridinol and
2-Methoxy-3,5,6-Trichloropyridine in Green Grass and Hay Following Application of
204
i ii i i
III Illllil
ill ll
-------
BIBLIOGRAPHY
MRID
CITATION
Formulation XRM-4714 Herbicide to Range and Pasture Grasses: Lab Project
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41969901 Ward, T.; Boeri, R. (1991) Garlon 4 Herbicide: Acute Flow-through Toxicity to the
Tidewater Silverside, Menidi a beryllina: Lab Proj ect Number: ES-DR-0224-6 1. 86-6 .
Unpublished study prepared by Resource Analysts, Inc. 26 p. - :
' - ' , j
41969902 Ward, T.; Boeri, R. (1991) Garlon 4 Herbicide: Acute Flow-through Toxicity to
Grass Shrimp, pugio: Lab Project No: ES-DR-02246186. Unpublished study
. prepared by Resource Analysts, Inc. 27 p.
41969903 Ward, T.; Boeri, R. (1991) Garlon 4 Herbicide: Acute Flow-through Shell Deposition
Test with the Eastern Oyster, Crassostrea yirginica: Lab Project Number:
ES-DR-0224-6 186-7. Unpublished study prepared by Resource Analysts, Inc. 26 p.
41971601 Ward, T.; Boeri, R (1991) Triclopyr Bee: Acute Flow-Through Toxicity to the Grass
Shrimp, palaemonetes pugio: Lab Project Number: ES-DR-0 133-7242- 12.
Unpublished study prepared by Resource Analysts, Inc. 27 p.
41971602 Ward, T.; Boeri, R. (1991) Triclopyr Bee: Acute Flow-Through Shell Deposition
Test with the Eastern Oyster, Crassostrea virginica: Lab Project Number:
ES-DR-0133-7242-14; Unpublished study prepared by Resource Analysts, Inc. 25
41971603 Gorzinski, S.; Lehr, K.; Piasecki, D.; et al. (1991) Garlon 4 Herbicide/Static Acute
96-Hour Toxicity to the Rainbow Trout, Oncorhynchus mykiss Waibaum: Lab
Project Number: ES-DR-022406 168-4, Unpublished study prepared by DowElanco.
33 P. '.; ' . . -. . , - ...
\ . ' - _
41971604 Gprzinski, S.; Lehr, K.; Piasecki., D.; et al. (1991) Garlon 4 Hernicide: Static Acute
96-Hour Toxicity to the Bluegill, Lepomis macrochirus Rafinesque: Lab Project
Number: ES-DR-022406 186-3. Unpublished study prepared by DowElanco. 33 p.
42053901 Ward, T.; Boeri, R. (199,1) Triclopyr BEE: Acute Flow-Through Toxicity to the
Tidewater Silverside, Menidia beryllina: Lab Project Number: ES-DR-0 1 3 3-7242-13
Unpublished study prepared by EnviroSystems Division & Resource Analysts, Inc. '
26 p. ' ' , .
205
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BIBLIOGRAPHY
MRID
CITATION
42090401 Baker, R. (1991) Response to Data-Call-in Notice (August 14, 1991)
Triethylammonium Triclopyr Product Chemistry. Unpublished study prepared by
DowElanco, Formulation Science and Technology Lab. 4 p.
IJIIl'JIlllii1":"'' IF '''111'!;1,* iii' fi'i'iiii
'
'111; Ilii;
i
ill inn11,j insi'i'iii
!::11, 'i!11! IPli!1 ;l
'::!!'! I*!!1'
K
iFlli'liiliilill!1:'.!!;,,!.1 i,', illlP!;,! 'HC 1: '
IPJIIIIIIiillllllllll'lll -IIII1' J1 I111!1]'!!!11',!,: << """:!ฃ[
42090403 Hamilton, T. (1991) Response to Data Call-in Notice (August 14, 1991)
Triethylanimomum Triclopyr Product Chemistry. Unpublished study prepared by
'"' f mil if!;,' ,,, " ^D'awEl^ncp?_ Formulation Science ''and Technology Lab 4 p
'42|p4P7i::,'Mgyes, M. (1991) Response to Phase'3 Submission 'on Triethylammonium Triclopyr
; I::;:;1'';'' .'i.;. ;;.|^<;ute^oxiat^ "Test for Freshwater Ksh-rBluegill: Lab Project Number: ES-199.
;;l|npubiished study prepared by Dow Chemical Co., Environmental Tox & Chem Res.
>p. ' ' ' ' ':
jli 1, '
IDA I
1
> '''IByQ^i n1 ' II i ill111! i1 'i i i " III1' ' I '' V.''.I ''':''-:- .' ',''
42090408 Mayes, M. (1991) Response to Phase 3 Submission on Triethylammonium
, j^(" ^ 'C ::::::Tjiclpp_yjr...Acute| Tpxidty^ Test for Freshwater Fish~Rainbow .Trout: Lab Project,
Number: ES-199. Unpublished study prepared by Dow Chemical Co., Environmental
, ':;;;:; :,:,:i:' ; ,:Tox '&"Chem Res. Lab! 9 p. '
Mmn W^iiffi^ fiSa.Kat:i ^fMtEf^-^ซ^ Stป WWM-tf-' :^: l1:.:;,-1;.
,
..... Response to Phase 3 Submssion on nethylammonium Triclopyr.
iiii,M,fli ..... i: ,:ปiii,,iii! I,, ya ........ ,.i. ..... .,; ..... I,,,,,. ............ .......... i, ...... ., .............. . ................. ! ........ ... .......... ..i. ,, ......... .,.,!,. .... ........ .. ,; ................ ..,, , ................. . ..... i*,, ,' ......... ....... c r ,
Test for Freshwater foyertebrate: Lab Project Number: ES-199.
"''Unpublished study prepared by Dow Chemical ..... Co., ^Environmental Tox,& Chem Res!
":Laix'7 ..... p. [[[ '. ...... : ...........................
ii
llll .1111111!::ซ Wl'liii.: '"'IS llflBii;
i'4IKJill!Ill1' ป ililllil'lllllli!!,: I'llli ,11"!:'
, .
'] - " liliNlii'llJ'lv - i"!'.iii| ..... i ..... ,"":,ซซ ,i!V ,1"! I Will :,',:!," V : ....... li:ii;""i::!i"rli! ...... "Eiiii."";!'.!!1"'1 ifiS'llW,,,!,: ,:'!' i!".;i i',,,1 1'1 .!,i'!i,"|1i. !!!:, ..... 'iLlWiik'l ..... " ''in:i,,i ii .li1;,,1'1,?.* !B iii11'!'1:1!':,,!'!:;:.,!/.1: '":!' ,1ป1:!li!*l'!!|i!i,. ".i 'lAiHiN ''iv' L ,;:,",; * , , . ., ; " , , , ' , , , ' j
42Q9;Q4|0 Mayes, M. (1991) Response to Phase 3 Submssion on Triethylammonium Triclopyr.
: ซ; i i ; .fiiiiFish Early Life-Stage Test-Fathead Minnow: Lab Proj ect Number: ES-582.
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l^"fcv>.:
;',i;,ii!'i; '"j::";!,.
y'lS'l': 'ฃ
. 'i: :L i.
''''I!'
iil
IH'Mllllil'illlll'Hllli!!'., illP'Vlll1!'
M. (1991) Response to Phase 3 Submission on Triethyl ammonium Trichlopyr.
:::;!,|nyertebMe,,yfe-Cycle Test (Daphnia): Lab Prpject Number: ES-583. Unpublished
study prepared by Dow Chemical Co., Environmental Tox & Chem Research Lab. 18
" "'!||i I'l,,'1',, iJ'.''!'" ป'... \ * ii ii mi in i i ; ' , '',1', "ii "i' .1 . "
kisivi.^;* ,;^2@0416 !,JPeteiso,n, J. (1991) Phase IV Reregistration Response for Triethylammonium
fI*"':ill' ':'/ 'ปit !!";i!'':f:fsTridpgyr. Ungubiished study prepared by ppwElancp, N?rth
^: * ' " "" "i:i:i!";;'": " '-livircSmentel Cneniistry Lab."" 22 p.''" "'" '''"'
-------
BIBLIOGRAPHY
MRID
CITATION
, 42090417 Baker, R. (1991) Response to Data Call-in Notice (August 14, 1991) Butoxyethyl ,
Triclopyr: Product Chemistry. Unpublished study prepared by DowElanco,
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42090418 Hamilton, T. (1991) Response to Data Call-in Notice (August 14, 1991). Butoxyethyl
Triclopyr: Product Chemistry; Unpublished study prepared by DowElanco,
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42090419 Hamilton, T. (1991) Response to Data Call-in Notice (August 14,-1991)1 Butoxyethyl
Triclopyr: Product Chemistry. Unpublished study prepared by DowElanco,
' Formulation Science and Technology Lab. 4 p. -
42090420 Hermann, E. (1991) Response to Data Call-in Notice (August 14, 1991). Butoxyethyl
Triclopyr: Product Chemistry. Unpublished study prepared by Dow Chemical Co.,
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42090421 Woodbur/i, K. (1991) Response to Phase 3 Submission on Butoxyethyl Triclopyr.
Aquatic Organism Accumulation. Unpublished study prepared by Dow Chemical
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42090422 Mayes, M. (1991) Response to Phase 3 Submission on Butoxyethyl Triclopyr.
Growth and Reproduction of Aquatic Plants Tier 2: Selenaestrum capricornutum.
. Unpublished study prepared by Dow Chemical Co., Environmental Tox & Chem.Res..
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42090424 Peterson, J. (1991) Phase IV Reregistration Response for Butoxyethyl ,
Triclopyr...Residue. Unpublished study prepared by DowElanco, North American
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42131802 Hermann, E. .(1991) Response to7: Data Call-in Notice (August 14, 1991): Subject:
Triclopyr Butoxyethyl Ester. Unpublished study prepared by Analytical Sciences Lab.
. s P. ' ;
' ., '. ... ' ' . j
42212701 Lockwood, D.; Szabo, J. (1992) Triclopyr Butoxyethyl Ester (Triclopyr Bee):. Probe
and 21-Day Dermal Toxicity Studies in New Zealand White Rabbits: Lab Project
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-207
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111 111
Iii
BIBLIOGRAPHY
CITATION
42339002 Puvanesarajah, V.; Stewart, R. (1992) Metabolism of carbon-14 Triclopyr in
L^ Lab Project Number: 39438. Unpublished study
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4211J8Q4 Hayeas, P. (1992) Response to Review of MRID 417322-01-Triclopyr
ฃE "i1;;:1 ! Z":' ::":;;":'."::":;.^PtQ^egradation"in Water:"Lab" Project Number:' PLH-63092. 'Unpublished study
Igg^i,j^i'v _,i|_.|,j,, |:ii,!,-,-, ,. ji i::j;;.Ajgp'^^j by DowEIanco 14 p.
I:!!' liiiiilili ?ป'' III''!ปI*''' iW1 . i 'ii. '!ป,i, ' In Iliffl 111"'::'!ป''! 1 '' "1"11 ', ' ' !" li1!,', *l ", !'. ' .,' A
-';i',i: iii i i;,:ii/ i- iiii,i.iii!, i 4 > s jiiiiiiiii :"iii, iii''. jr::' a'-, t:: rti "ft A ::.,;::, ii i r".' i it ilrjiji ,a i "K' * ii i ;*!.' ii i f i; ป ' -,- .'.',' :t, i;
-------
BIBLIOGRAPHY
MRID
CITATION
ES-2592: DECO-ES-2592. Unpublished study prepared by The Dow Chemical Co.
38,p., ; ;
42721101 Hughes, I; Alexander, M. (1993) The Toxicity of Triclopyr Butoxyethyl Ester
, (Triclopyr BEE) to Anabaena flos-aquae: Lab Project Number: ES-DR-0133-7242:
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42721102 Hughes, 1; Alexander, M. (1993) The Toxicity of Triclopyr Butoxyethyl Ester
(Triclopyr BEE) to Naviculapelliculosa: Lab Project Number: ES-DR-0133-7242: .,
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42721103 Hughes, J.; Alexander, M. (1993) The Toxicity of Triclopyr Butoxyethyl Ester
(Triclopyr BEE) to Skeletonema costatum: Lab Project Number: ES-DR-0133-7242:
(ES-2531. Unpublished study prepared by Malcolm Pirnie, Inc. 38 p.
42726701 Yackovich, Pt; Lardie, T.; Brink, D. (1993) A Metabolism Study of (carbon
14)-Labeled Triclopyr Applied to Perennial Ryegrass: Lab Project Number: GH-C
3012. Unpublished study prepared by DowElanco North American Environmental
Chemistry Laboratory. 137 p. ,
42730601 Buttler, I; Roberts, L.; Siders, L.; et al. (1993) Non-Crop Right-of-Way Terrestrial
Dissipation of Triclopyr in California: Lab Project Number: ENV91019. Unpublished
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42775001 Gardner, R. (1993) Triclopyr Method for Chicken Tissues and Eggs: Supplemental to
. Original Method: Determination of Residues of (3,5,6-Trichloro-2-pyridinyl)oxy
acetic Acid.in Bovine Milk, Cream, Muscle, Liver, Kidney, and Fat by Electron
Capture Gas Chromatography: Lab Project Number: 86105.01. Unpublished study
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42784301 Gardner, R. (1993) 3,5,6-Trichloro-2-pyridinol: Method for Chicken Tissues and
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. f
42821301 Havens, P. (1993) Supplemental to MRID No. 41714304: Additional Data for Lake
Seminole Aquatic Dissipation Study: Lab Project Number: PLH062193. Unpublished
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209
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42884501 Wippdburn, K.; Rick, D.; Kirk, H. (1993) Triclopyr Bee: Acute 96-Hour
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;! IS*:; & - :; ,|||!:: ;S:::'!:;, ฃffiie^,,Nu:inb?r: PPCP;?.!5:?6.!^ Unpublished study prepared by The Environmental
*K.vX$l&ฃs$ogy & Chemisiy Research Lab., Dow Chemical Co. 31 p.
^^^
Determine the Effects of Triclopyr on Seed Germination and Seedling Emergence:
Lafe Project Number: MLJ083093. Unpublished study prepared by DowElanco. 11
,i,,,,,i v. .,. ,,, , (T ;i, , i:i,,,i,,,,,,,,,;, ^ n^ K.j Hugo, J.- Kirkt H. (1993) Triclopyr BEE: Acute 96-Hour
ii|SWj-j|ri '.;: ;;: ^irV^i^flp^-J^flP^ Toxicity to the Bluegili, Lepomis macrochirus Rafinesque: Lab Project
= =;:';;;;:: ;: i;: '..'. ,;=!;;"?'., . r.\. ^i^HRiber: DECO-ES-2620. Unpublished study prepared by The Environmental
|^ 31 p.
4300766! Havens, P.; Shepler, K. (1993) Photodegration of (carbon 14)-Triclopyr Butoxyethyl
III !^f;^ :.',"' IliJ 'Tf 1?^-%^ !S,,^'(B,SlirelAqueous Solution at PH 5 by Natural .Sunlight: Lab Project .
Number: 330W-1: 330W: ENV91090. Unpublished study prepared by PTRL West,
'~~' ;;;;;; ; ;;; ", ~; ,;L " ;.";.., Inc. and^powElancp, Nv American Enyironmental.Chem. Lab, 103 p.
88:*'i1ป!$!v S^SI'f^"::i'-:^!yer> ""^' CoฐlQy> T.; Schuster, L!. et al. (1993) The Dissipation' and Movement of
|(ir,i, fj^'l'if ""!:' if;!; ';i ;:';!; Triclopyr in a Northern USA Forest Site Preparation Ecosystem: Lab Project
!" " Hnber: .ENV91087: PM91-2502," Unpublished study prepared by Pan-Agricultural
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43033401 Petty, D.; Gardner, R. (1993) Right-Of-Way Terrestrial Dissipation of Triclopyr in
,,,... I I,:,: : I,,'.: ,:;;';;, ,', ;^9fi feSllPS :L^,feRJect Number: ENV92049., Unpublished study prepared .by
pi If Hi $ i :-;! Ili ;:|'i-''::' ;SH pewElincp .Chemistry Lab. 125 p.'
1 '' '''
ISItJili:'" iiiff'isL.'i;!:!:;;!! ":i/';\ ilhi
:ป!li!!i!' I'lllPlll1"''I ! "'hiii,!1!
;|jr;|;.:,;L:;||, >'43122102 .Yackovich,. P.- Ng, C. (1994) A Metabolism Study of (carbon 14)-Labeled Triclopyr
||!;!;;ffi;,;'.'" MM'"' 't|h.;'^pplie3 to Perennial Ryegrass Supplemental Data to GH-C 3012, MRID #
^;p'.: :|L -' ^'^^:x::;f4272S^pl;Ta.'b" Prpj ecf Number:' "JVETSipoflS.' Unpublished'study prepared by
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ฐ ' "
mergence, and Vegetatve Vigor of Non-Target Terrestrial Plants: Final Report: Lab
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,T\C\
ฃj J. \J
1-; .iilMr .:i',,;i I1 ,'vS1 ป '''..',' " :" 'i-- ' .h1 viiiiii.;, ,'i r .|,
il'BnilliUi..,1'"..I ITIIii'lilA;1;!.";! 'Hill, li j.'
l'i!,,[,'' !;"!:,!!! ซ, ป! Ji'i ! Jlilliniliiiiii'i !li.,i' 'I1 " ,* n ; r,;r .
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43217601
Bryson, A. (1994) Triclopyr Butoxyethyl Ester: A Study of the Effect on Pregnancy
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43217603
Bryson, A. (1994) Triclopyr Triethylamine Salt: A Study of the Effect on Pregnancy
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Weinberg, J.; Hugo, J.; Miller, J; (1994) Evaluation of the Acute Toxicity of Garlon 4
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. ' _ . >. - ' -
43545701 Vedula, U.; Breslin, W.; Kropscott, B.; et al. (1995) Triclopyr: Two-Generation
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213
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
OCT 27 IS38
CERTIFIED MAIL
Dear Sir or Madam: '
This Notice requires you and other registrants of pesticide products containing the active,
ingredient identified in Attachment A of this Notice, theData Call-in Chemical Status Sheet to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your produces)
containing this active ingredient. Within 90 days after you receive this Notice you must respond as
set forth in Section in below. Your response must state: .->'.
1. How you will comply with the requirements set forth in this Notice and its Attachments 1
through 6; or '
2. Why you believe you are exempt from the requirements listed in this Notice arid in
Attachment 3 (for both generic and product specific data), the Requirements Status and
Registrant's Response Form, (see section ni-B); br ..
3. Why you believe EPA should not require your submi ssion of data in the manner specified by
this Notice (see section ni-D).
/ __ - - . -
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the; registration of your
produces) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2. All products are listed on both the generic
and product specific Data Call-In Response Forms. Also included is a list of all registrants who
were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
215
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; You are required to submit the data or otherwise satisfy the data requirements specified in the
Requirements Status and Registrant's Response Forms (Attachment 3) within the timeframes
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established. ., ,
, These EPA Guidelines are available from the National Technical information' Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (Telephone number-
703-487-4650). . ' :
Protocols approved by the Organization for Economic Cooperation and Development (OECD)
are also acceptable if the OECD recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR 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]. '
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION Mcti^fE) 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 til. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this .
Notice. The type of Data Call-in you must comply with (Generic or Product Specific) is specified
in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
IH-A. SCHEDULE FOR RESPONDING TO THE A(
The appropriate responses initially required by this Notice for generic and product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
' 217
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if II11) (ill
lllilliliiiilllil
I IIH i II In In iilllillil
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.
iiiiiiliiiiiiiiiiifiiiiLiiii'iiii'iiiiiii'iiii'iiiiiiiiii'iifiiiiii'iiiiiiiiiiiiijiiiijjjjiii 'ii;!*!''']'""'""ifill1"'1!1!!!l!11!!1!1!!1*11'111'!! !f'I!11'''!!*''1"1*1''!'!'"!" I!!1 '!i!!!iilll!l!!'!"!!! jl!!il!!ll!|l!l'!l!l!i'1;: 'ii!!!!!!:!l!!!il"i"|l|i"!iii!:i';'"!'l: |::'I1'1!!1'!1!!1"1!!1111!1'!1'i1"''"; "'I1'
SI1 if-
OPTIONS FOR RESPONDING TO THE AGENCY
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1, Generic Data Requirements
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Two forms apply to generic data requirements, one or both of which must be used in
=ฃ::ฃ= iresjjpnding to tEe Agency, depending upon your response. These two forms are the Data-Call-in
=~ ' 6ซr,ซ^^r.^ ffซ^, ซ^a +CQ r>^,,;m^^ gg ^j, |^eg^s|rail|'s Response Form, (contained in
Data Call-in Response Forms must be submitted as part of every response to this Notice.
IpllllIB JHIIIll , HIU ฃ ; || ฃ H ^ ^ T
.e Requirements Status and Registrant's Response Forms also must be submitted if you do not
ummu ซ'ii!'ป||ugjj|y fQT a Generic Data Exemption or are not requesting voluntary cancellation-of your
registrations). Please note that the company's authorized representative is required to sign the
first page of both Data Call-In Response Forms and the Requirements Status and Registrant's
Response Forms (if this form is required) and initial any subsequent pages. The forms contain
separate 3etai!ed instrucSons on tEe response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachrnent 1.
I'll! Illlllllll Ill 111 II till ill III II I I1 Illl III1 III 111 I (Ml I I1 III I 11 lM II I' I I II I ill |l 11 i '11(1
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a,' Voiuntarv Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
productfs) containing; the active ingredient Sat is the ^bject of this Notice. If you w_ish to^
voluntarily cancel your pro3uct] you must submit completed Generic and Product Specific Data
Call-In Response Forms (Attachment 2), indicating your election of this option. Voluntary
these aje the only forms that you are required to complete.
! " I ,!, '' ' /
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance p with.the Existing Stocks provisions
Of this Notice, which are contained in Section IV-C.
ft!".', Mป
':= ^^^^.^..g^^ ^ respond if you choose the Voluntary Cancellation option, the Delete
liii^^.^rl^SS^ oP^on or tEe i Generic Data Exemption option is presented below. A discussion of the
yarlous options available for satisfying the generic data requirements of this Notice is contained in
'^jSectipjiJH-C. A disc^s|on^foptions relating to requests for data_ waivers is contained in Section
I lili
,11 111
P
I" I
1(1 II ! l II III
218
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b. Use Deletion - '
You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Attachment 3), a completed
application for amendment, a copy of your proposed amended labeling, and all other information '
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements .Status and Registrant's Response Forms. You must also,
complete a Data Call-In Response Form by signing the certification, item number 8. Application
forms for amending registrations may be obtained from the Registration Support Branch,
Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-83 58.
If you choose to delete the use(s) subject to this Notice or uses subj ect to specific data
requirements, further sale, distribution, or use of your product after one year from the due date of
your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption - \
Under section 3(c)(2)(D) of F3FRA, an applicant for registration of a product is exempt from
the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is. derived exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not.suspend the registration of a product which would: qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met: " ..'.','" ,' -
. . . * i .
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient and is
purchased from a source not connected with you; ;
(ii). Every registrant who is the ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and must
remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement of
Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-In Response
Form. Attachment 2 and all supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-in Response Form. 'If you claim a generic data exemption you are not
,required to complete the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for responding to product specific data requirements.
219
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if you are granted a Generic Data Exemption, you rely on the efforts of other persons to
IP/jllll^ [ฃ *'prgvide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Data Call -In Notice, the Agency will consider that both they and you are
normaDy initiate proceedings to suspend the registrations of both your
and their produces), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.
d. Satisfying the Generic Data Requirements of this Notice
J Illllllllllllllllllll Illllllllllllllllllllll lllllllll IIIIIIH 111 I IP III 111 I lit 111 II 111 II II 111 I "I I III I II I II I I 1111 II I I
:i There are various options available to satisfy the generic .djate requirements of this Notice."
These options are discussed in Section IS-C.1. of this Notice and comprise options 1 through 6 of
item 9 in the instructions for the Requirements Status and Registrant's Response Form and item
6b gnthg Data^Can-In Response Form. If you choose item 6b_ .(agree to satisfy the generic data
^ ^..: jj^gl sugmgm"e p'afo cgfl'.jfl Response Form and me Requirements Status and
other information/data_ pertaining to the option chosen
to address the data requirement. Your response must be on the forms marked "GENERIC" in
item number 3.
::;:: i:;:::::;:,::;::::,::,:-:;;;e. Request for Generic Data Waivers.
i I JIliK iiiE .' ; ""i:' -ili,':: ',; .,:' i*1' i,',u
Waivers for generic data are discussed in Section HI-D.l. of this Notice and are covered by
8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
^^f^y^MJResppns|.Fpnn.. ff you clioose one of Sese options, you must submitboth fbrrns^ as well as any^
J11^^^^^^^^^ : .*'6tfierinformaSon7dAta pertaming to the option chosen to address the data requirement.
illlllllllP'iilllllllllllllllllllllllPI ij IlilllllHII.''^'''!!!',!!!]!!, ,11! ,11 1 i I'liilllllllihllliiJIIIiplliil1 llill"IPlllllPIIII llilJL'1: lill|llil JIHIIIIiJIiJ:"11!! , Jlilllil I !,,ซ! S* A , , *-
llillli,jliillllli li lllBlllpHJlipLiib !lilii;,'ip|ililiii!' ''ipu'li' 11! llllilllliiiii, i !:,|iI!:"i| lihllliniiviiiil ':'"!\b:iiiilliPliiiltliris:,'i,III!;:''illiilillilili"i,: ,,ii||iiiliui|ip"i,'it iii,i!!,, it'"|i>"Iji'nlPJIili;lliNliiiThiiiiliiiFni'lliif iiilitltiK'iJiw'! ill,"'liii i"' "'W.lillll!|lซ ilniiiiiillft itipf,'|i!lnl";"li;i''!i,f i"'",:''VVf ii1 i'i'',*H 4 '1"''''i'ili''.1' 1'l||i!1'''''t'1'?''*< '':iiiiiii
-------
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 fhis
form is required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If,you have questions or
need assistance in preparing your response, call or write the contact person(s) identified in
Attachment 1.
a. Voluntary Cancellation '
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
product(s) containing the, active ingredient,that is the subject of this Notice. If you wish to,
voluntarily cancel your product, you must submit a completed Data Call-in Response Form
indicating your election of this option. Voluntary cancellation is item number 5 on both the'
Generic and Product Specific Data Call-in Response Forms If you choose this option, you must
complete both Data Call-In response forms. These are the only forms that you are required to
pomplete. .
If you choose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed in Section III-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-in
Response Form. Note that the options available for addressing product specific data requirements
differ slightly from those options for fulfilling generic data requirements. Deletion of a use(s) and
the low, volume/minor use option are not valid options for fulfilling product specific data
requirements. It is important to ensure that you are using the correct forms and instructions, when
completing your response to the Reregistration Eligibility Decision document.
c. Request for Product Specific Data Waivers. , '
Waivers for product specific data are discussed in Section ni-D,2, of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-in.Response Form and
the Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on the
forms marked "PRODUCT .SPECIFIC" in item number 3V
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
221
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"1." Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy the
generic data requirements (i.e. you select item number 6b), then you must select one of the six
options on the Generic Requirements Status and Registrant's Response Form related to data
production for each data requirement Your option selection should be entered under item number
rS FซfSBss^Jซi-9, "Registtant _Resp_qnse." 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
ii!i;Response Form. These six options are listed immediately below with information in parentheses to
guide you to additional instructions provided in this Section. The options are:
ii1,; in 11 ii i in ii ii i in ii nil ii ii in nil 111 iiiiiii i ii i inn ii ill ii ii ii 111 ill ii ii i ii i ii i ii i n ill 11 ii i inn 111 nun 111 inn 1111 inn ii i i in nil i nn inn in in in i i nn n in in i in j i iiniinnii n inn i
(1) I will generate and submit data within the specified timeframe (Developing Data)
JiliilViW I' IlllJW* '"ฅ r ' T" ' 1 i 7 '" ' T STS " "" * ' ' 8 - ^ , f , ' ,
2) I have entered into an agreement with one or more registrants to develop data j omtly
" (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) Lam submitting an existing study that has not been submitted previously to the
,: -i: - , :;,;;;;,;,: ;- - - ;;" -.Agency by anyone (Submitting an. Existing Study)
^^'^"r: "(5) I am submitting or citing data to upgrade a .study classified by EPA as partially
i 1,1,i j|| acceptable and'upgradeable (Upgrading a Study)
l&KHftSM |P_(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)
in, , .,,.. , y in n i i nun nn ii iiiiiiiiiiiiiiiiii i ii i i ii ii i i ii in ii i jln ii 11 111 i i ii ii 111 i i i i i 111 i ii i I in n >\ i
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency guidelines
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
| l^jlllllll I 111 II II III /? J I ฐ V i: .11,.-
conformance with, the requirements of PR Notice 86-5. In addition, certain studies require Agency
"^apprcJval of test protocols in advance of study initiation. Those studies for which a protocol must
^.iฅe submitted have feeen.identifiedin, the Requirements Status and Registrant's Response Form
iriand/or footnotes to the form. If you wish to use a protocol .which differs from the options
;f [discussed in ^ction^n-C^oJlti^^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
speHfied in Section H-C. If the Agency rejects your protocol you will be notified in writing,
ever, you should be aware that rejection of a proposed protocol will not be a basis for
IllW1 * d:T 3 "ซ"ซ y r11' '" ซ '"" i? 3 T s""" ^ "'" '' " ''" ' ' ' "
ending the deadline for submission of data.
X pfbgress feport'must be submitted for each study within 90 days from the date you are
^ffi^ejd to commit to generate or undertake some other means to address that study requirement,
i^^^^^^ "ป""such as making an offer to cost share or agreeing to share in the cost of developing that study.
iiiiiiiiiiiiiim:!:!! i 'ii< ' iiiiiaiiinii iJi,i , < .i:r IRJII ' ,: a :'t ' -m1! Jiniiini "HUM \fปv vw t IN I'lnini; ' TIHIIII, *' H|l <
"'I"""., ....... Tliis 90-day progress report must include the date the study was or will be initiated and, for
e " ~" ' "" '
to be started" within 1 2 mo~n"ths 6T commrttnenf.' "the" name 'and address of the
........... , ................... ................ ,, ...... ......................... , ..... , aiii':;'1! . ,.,..... ..... ; '!;BI!l>i:l! ...... fl'iiMW^^^^^^ ..... linn- ...... if nun ..... ninin ........ inn*!; ....... : u1 1; '' : ....... ' & . ' '< ........ ~ ,
zisfxsxli ..... ii:::::: ....... il laboratpryfies) or individuals who are-or will be conducting the study.
222
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i r;i ,1,1! i^n' 11 ::L iniiii' in ''rr1; niiJi in,, 'n^iniw 'in iii'ji'
'i ....... If ti ,.:.'.
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ill!!1!!
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In addition, if the time frame for submission of ,a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other information
specified in the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full description of any problems encountered
since the last progress report. .
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is.allowing for the submission of completed study reports or protocols.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subj ect to receipt of a Notice of Intent to
Suspend the affected registrations). . -
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-byrstep basis: You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA'does not grant your request,
the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions will
not be given in submitting the 90-day responses. Extensions will not be considered if the request
for extension is not.made in a timely fashion; in no event shall an extension request be considered
if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required data tut
will not be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the other
registrant1 s' acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration. '
. s.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been unsuccessful, you may request
EPA (by selecting this option) to exercise its discretion not to suspend your registration(s),
although you did not comply with the data submission requirements of this Notice. EPA has
223 ' ,.
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^LซSWBJH^ซKMTWtfS !iS^^^^^ ' '
B ,' K.wwjiuwjih'i sis ''Siui!i|iii . i 'iftuMi , IE..! EEiitii1 EWC* K.iu.^rwif awiซa,:!ปf tw ai tr i;:i BII ivii^^^^ ป in v nil "f!9fS'Si!>t?V*i>< I''*''!-!"! "s "liSiiy :'>:" "IK >' , '*' /''
I'iiHHIilll' .Elillll1! 'I:
li:i":!9 |:!U.lVHIItM**I *;.
i i lini" si'.11;.
; te, s,<ป
i i ซiw(ซ
hiKiHili;; 'fiiiiiiiii'iiii
**dejenmi^ thatas 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
-^nteynto a joint data deyelogment/cost sharing program, but the other regjsjrant(s) developing
me data has rertise3 to accept the offer. To qualify for this option, you must submit
imentatipg to tEe Agency proving that you have made an offer to another registrant (who has
^^Mon^to's^mit'Ha^ to'sliare mt5ieTurHen"6?'d^ must also submit
>'^t^S^^^^^a^ ^SES^l^'ll^Z01131 857ฐ-32, Certification of Offer to Cost Share in 'the
:i"T6evel6pment o'FSata^ A^ttacEment 6. 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 pฃpฃf oftiie other registrant's receipt of that offer (such as a
certified mail receipt). Your oSer must; in ad3iSon to anytEing else, offer to share in the burden of
producing the date upon terns to be agreed to or, failing agreement, to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)ftii)' and must not qualify this offer. The other
, ; llpllllljl, , /(I I . llllllllllllllliilllllllLhJIIIIIIIIIIllillilllllllllllllllllilllLlllllllllllllillllllTil;;;, , , llilll & iJl i Sllllnlli jj i imii i,| ,J m * ! m ซl JIN I' IIII .
'tiiff&glstrant must also inform ฃf>A of its election of an option to develop and submit the data
required by this Notice by submitting a Date Call-in Response Form and a Requirements Status
"";jfoffl-|fegfctrantis ReSp0nse Form committing to develop and submit the date required by this
IF IllllliliilluBlilllllliliiiffl "'Wlilllllj
^Q^Q^^gpg^glQ^-^-g-gjr-^g option, you may not withdraw your offer to
of developing the data. In addition, the other registrant must fulfill its
to develop and" submit the data as required by this Notice. If the other registrant fails
to develpp the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant normally will be subject to initiation of suspension proceedings, unless
i'iE'yoU commit to su'Emlt^' and" 3o"su'b"miฃ me. reqiurecf'datei! in the specified time frame. In such cases,
i;-,thฃ Agency generally will not grant a time extension for submitting the data.
^^ lull".
'Option 4. Submitting an Existing Study
,, I|,,I!|L,, .., If you choose to submit an existing study in response to this Notice, you must determine that
e: study satisfies the requirements imposed by this Notice. You may only submit a study that has
been""pfeviously submitted to the Agency or previously cited by anyone. Existing studies are
g pre^fe is'suaiiceof'tnis Notice. Do not use this option if you are submitting data to
eady.^SeeOption5). ' ' " ' "" """ ""
IVllllU
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
i 11 MI i, in i in iiii i i ฐ J J J J
be repeated.
i*
=To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
.
iiii i i i i in ii mil i iiiiiiiiiiiii i i mi 11 iiiiiiiiiii in i nil i i i r in in in i i i ill i i ' ''
la. 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
224
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Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160,3, Raw
data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof,
that are the result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be substituted, for
. . the original source as raw data. 'Raw data1 may include photographs,.microfilm or
microfiche copies, computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or analysis.."
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 also must certify at the time of submission of the existing study that
such GLP information is available for post May 1984 studies by including an appropriate
statement on or attached to the study signed by an authorized official or representative of
the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline relevant to
the study provided in the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the Pesticide Assessment Guidelines
(PAG) or meets the purpose of the PAG (both documents 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 15 8.70 which states the Agency's policy regarding acceptable protocols.
If you wish to submit the study, you must, in addition to certifying that the purposes of the
PAG are met by the study, clearly articulate the rationale why you believe the study meets
the purpose of the PAG, including copies of any supporting information or data, it has been
the Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of the
criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must identify
any action taken by the Agency on the protocol and must indicate, as part of your certification,
the manner in which all Agency comments, concerns, or issues were addressed in the final
protocol and study. ,
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary: and copies as required by PR Notice 86-5.
225
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If you acknowledge on the product specific Data Call-in Response Form that you agree to
satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you must
select one of the six options'on the Requirements Status and Registrant's Response Form related
to data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are: .'... '.-,-.
(1) 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 The requirements for developing product specific data are the same
as those, described for generic data (see Section ni.C. 1, Option 1) except that normally no .
protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data -- If you enter into an agreement to cost share,
the same requirements apply to product specific data as to generic data (see SectionTJI.CJ,
Option 2). However, registrants may only choose this option for acute toxicity data and certain
efficacy data and only if EPA has indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group. The registration number of the
product for which data will be submitted must be noted in the agreement to cost share by the
registrant selecting this option. .
Option 3. Offer to Share in the Cost of Data Development The same requirements for generic
data (Section niC.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study The same requirements described for generic data (see
Section in.C. 1., Option 4) apply to this option for product specific data.
, ' ' /
Option 5. Upgrading a Study The same requirements described for generic data (see Section
in.C. 1., Option 5) apply to this option for product specific data.
227
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(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient for each
major use site. Present the above information by year for each of the past five years. '
(iii) Total direct production cost of product(s) containing the active ingredient by year for
the past five years. Include information on raw material cost, direct labor cost, advertising,
sales and marketing, and any other significant costs listed separately.
: *
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and equipment) "
charged to produces) containing the active ingredient by year for the past five years.. Exclude
all non-recurring costs that were directly related to the active ingredient, such as costs of initial
registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type of waiver
sought and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing heeded to fulfilleach of these data requirements. .
(vi) A list of each data requirement for which you are not seeking any waiver and. the ..
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales (pounds and
dollars) of the active ingredient, direct production costs of produces) containing the active
ingredient (following the parameters in item 2 above), indirect production costs of product(s)
containing the active ingredient (following the parameters in item 3 above), and costs of data
development pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active ingredient to users.
Discuss the use patterns and the effectiveness of the active ingredient relative to registered
alternative chemicals and non-chemical control strategies. Focus on benefits unique to the
active ingredient, providing information that is as quantitative as possible. If you do not have
quantitative data upon which to base your estimates, then present the reasoning used to derive
your estimates. To assist the Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide information on any of the following
factors, as applicable to your produces): (a) documentation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives, (c)
information on the breakdown of the active ingredient after use and on its persistence in the
environment, and (d) description of its usefulness against, a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination regarding a
request for a low volume/minor use waiver will result in denial of the request for a waiver.
b. Request for Waiver of Data
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-
si!; f|]i|i|ii;i:| i; i|| iiiuiiiiKij,, n' iili i'f 'i iiiiiiiiiiiiiinii{iiiiiiii:i>iiiiii IKI iiiniiHiiriiinrji js'i iiwivii; "W1 "M t iiiiiiiiiii"', i isiiiiiHii;i*r! "Jiiii 'W iliilliiiiliiiW^inBi..,::''!!!!!:!1::, iiiin'iiiiiEiiiii! ""HM1";1,!, jii:isi ID vm \ j v' '\งmfwป'ifp,1: iiig jiil: i; i ijiij ซi iii; i j ฑr 'ป^SS"1, '"li11!"!!!?11! !l!i'I ,:"!l!i',?!!!!!!' S31''!!!' I'1' i
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2. Failure to submit on the required schedule an acceptable proposed or final protocol when
such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any option
chosen to address the data requirements (e.g., any required action or information pertaining
to submissions citation of existing studies or offers; arrangements, or arbitration on the
sharing of costs or the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to comply with any
terms of a data waiver). .
6. Failure to submit supportable certifications as to the conditions of submitted studies, as
, required by Section IH-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of a
registrant on whom you rely for a generic data exemption either to: ,
a. Inform EPA of intent to develop and submit the data required by this Notice on a Data
Call-In Response Form and a'Requirements Status and Registrant's Response Form.
b. Fulfill the commitment to develop and submit the data as required by this Notice; or
c. Otherwise take appropriate steps to meet the requirements stated in this Notice, unless
you commit to submit and do submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above,,at any time
following the issuance of this Notice. ,
'231
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i in i inni 11 in i IK iiiii iiiiiiiiiiii HI i in i i inn in in i in 111)111 in I in in i i in nil in in 11 in in in i i 11 n i 11 in nil in i inn in l
IV-k. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
! ""' UNACCEPTABLE ' ' '
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
fqr 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
jlference, (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
^s^^^sGujddines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
:;~^^^^ -i^-^poirBng of required studies. Such requirements include, but are not limited to, those relating
g tesl^igalenal., test procedures, selection of species, number of _animals, sex and distribution
^,':;'ff5r animals, dose an3 effect levels to be tested or attained,,,duration of test, and, as applicable,
Gj3O,i;L|b;Q|3|ory Practices.
ฅ?!= islis i? iifl"' i i'"!if\i'&'"if"-': i' 'i"1"1" "Si' '-:'"; i. '':'' '. i";'
iliiliiia
2) EPA requirements regarding the submission of protocols, including the incorporation of any
j:1^^^^ -".changes required by the Agency following review.
ป; j ' :" ; - 3)' EPA .requirements regarding the reporting of data, including the manner of reporting, the
J^^^BM;iis "illofipleteness" of results, and the adequacy of any required supporting (or raw) data, including,
:Jirnited to, requkements referenced or included in this Notice or contained in PR 8 6-5.
i must be submitted in He form of a final report; a preliminary report will not be
considered to fulfill the submission requirement
iMMMi'>' HIM in in mi in u i i iiiiiiii 11 i n i iii( nil i n i i i n iiiiiii i i i i i i i
'..C EXISTING STOCKS OF SUSPENDED OR. CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks of
Ill III 111 I 111II IIIIIII IIIIIII I III I I 111'' ^ *! I J ฐ
:;::=";:; a pesticide product which has been suspended or cancelled if doing so would be consistent with
iSBT-J'fthe purposes of the Act.
! ............
iai ............. The Agency has determined that such disposition by registrants of existing stocks for a
Siispended registration when a section 3(c)(2)(B) data request is outstanding generally would not
be consistent with |he Act's purposes. Accordingly, the Agency anticipates granting registrants
pifinissipn to sell, distribute, or use existing stocks of suspended produces) only in exceptional
iJS-vi'i^tfuinSterwes. ...... if jou believe such .disposition of | existing stocks^ of your produces) which may be
' . ....... '.':"งJEfงi5Si'ded 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.
! = ' l^ou also must explain why an "existing stocks" provision is necessary, including a statement of
i "^'the'qu'anEty of existing stocks and your estimate of the time required for their sale, distribution,
,?!anS 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.
u request a voluntary cancellation of your product(s) as a response to this Notice and your
ct is in full compliance with all Agency requirements, you will have, under most
Qnsryeaf from the date your 90 day response to this Notice is due, to sell,
i!E^^^^^^^^^^^
lii " fflf ' !' illlllR1 if 3i.ii-1. ""I i'Hf"! IBf" lilt SIIIIJ : W '!'" i'- A' J".,1 W" 1 ' ttili!" i '"VW* '!f W JBtKWT US iil! WMK "XiSi IBS1 v SI? it i ifli'lllil f "It, i'-li1" , 'I.' :,!':' >,: ', \ A. ;' '. ir.,. i ",.'} ;,'" >",. "I:: fSiii. i .| Is/ :', ifjl
232
i lidii' ': if11 iiiii- ii iiii. - ':r;-"j J ป fป' -1 iii ' 't j ' i i: f ii>: i -i; '-vk I-B S:, : iซi';i (Vi 4 iis
fljlilf '
i* 'i..S*,.-;,;i,' v1:;*. ,v^*, e: ,. ,';, .' t
-------
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 a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the agency granting any additional time to sell,, distribute, or use existing
stocks beyond a year from the date the 90 day response was due^ unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements
' of this Notice. For example, if you decide to voluntarily cancel your registration six months before
a 3-year study is.scheduled to be submitted, all progress reports and other information necessary
to establish that you have been conducting me 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 thatFIFRA 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 j, the Data Call-in Chemical Status Sheet.
All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms (Attachment
3), for both (generic and product specific data) and any other documents required by this Notice,
and should be submitted to the contact person(s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the Generic and Product Specific
Data Call-in Response Forms need be submitted.-
233
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iiiiiiiiiiii in ini i1 INI hi "iiiiiiiiiiiiiiiiii m iniii iiiiiiiiiii
lillillil i 111 II Will I 111 111 I 1
'I ,.'': *'ซ:" (>,i ; ".<
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.
' Hi 111! 1 lilfi'iiliilllill 'I HI i Pill I 'I" I I il i1,, I'll M\
Sincerely yours,
i, Direc/or
Special Review and
Reregistration Division
Attachments
(The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-in and Product Specific Data Call-In Response Forms with
111 Instructions t , ;
3 - _Generic Data Call-in and Product Specific Data CaJl-Ip Requirements Status and
Registrant's Response Forms with Instructions
4 - EPA Batching of 3Bnd-Use Products for Meeting Acute Toxicology Data
Requirements^orReregistration ' ' '
5- LJst_of_Registeants'R^eivin"g This Notice
& - Confidential Statement of Formula. CosFShare. Citaion jof Data and Data Matrix.
Forms
..
'tpi fCt IS.' ".v-SVVii
111 in II 11111 ill
234
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TRICLOPYR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing Triclopyr. . .
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 Triclopyr . 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 Response Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting
Acute Toxicology Data Requirement (Attachment 4), (5) a list of registrants receiving this DCI
(Attachment 5) and (6) the Cost Share, Citation of Data and Data Matrix Forms in replying to this
Product Specific Data Call-in (Attachment 6). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE ''.''.
The additional data requirements needed to complete the database for are contained in the
Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on 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 products.
INQUIRIES AND RESPONSES TO THIS NOTICE. ' ,
If you have any questions regarding this product .specific data requirements and procedures
established by this Notice, please contact 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 7508C '
Office of Pesticide Programs ,
U.S. Environmental Protection Agency
- Washington, D.C. 20460 . ,
. RE:'Triclopyr
235
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BMUfiiwiM'KW,:
E;
'""'jjXj^^^ ^"'.\""'',,"'',''.',,'"'!,''" ' "''.',!'..',',,i!'J,"( *"
You have been sent this Generic Data Call-in Notice because you have product(s) containing
TriclppyE
)W ill1
iiiii
iiiiiiiii
This -Ggn.gnc_Data Call-in Chemical Status Sheet contains an overview of data required by this
notice, and point of contact for niqmriespe^ of Triclopyr. This attachment
is to be used in conjunction with (I) 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 3),
(4) a list of registrants receiving this DCI (Attachment 5), and (6) the Cost Share, Citation of Data
and Data Matrix Forms in replying to this Generic Data Call In (Attachment 6). Instructions and
guidance accompany each form.
DATA REOUIRED'BY THIS NOTICE
The additional data requirements needed to complete the generic database for are contained in
the Requirements Status and Registrant's Response. Attachment C. The Agency has concluded that
additional product chemistry data on are needed. These data are needed to fully complete the
reregistration of all eligible products.
INQUIRIES AND RESPONSES TO THIS NOTICE
Illllll I'll I UK
in iiiii iiiiiiiiin i PPI
iiiiiiiiiiii i iiiii i i nil
' ..... IN
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|f you have any questions regarding the generic data requirements and procedures established by
this Notice please contact Dean M.onos at (703) 308-8074.
llll 1 1 V n 1 1 11111 l in n i iiiiiiiii n inn 1 1 iniiii i iiiiinn i in in i i i in i i i ti 1 1 1 in i i i in mi ii in in linn ii
All responses to this Notice for the generic data requirements should be submitted to:
Dean Monos? Chemical Review Manager
Reregistration Branch HI
Special Review and Registration Division (7508C)
Office of Pesticide Programs
IXS. Environmental Protection Agency
Washington, D.C. 20460
IIIIIIIII I I II I II IIIIIIIII I' I I II II II Ml llll II II I I III
RE: Triclopyr
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-in Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-ins as part of
EPA's Reregistration Program under the Federal Insecticide, Fungicide, and Rodenticide Act. If
you are an end-use product registrant only and have been sent this DCI letter as part of a RED
document you have been sent just the product specific "Data Call-In Response Forms." Only
registrants responsible for generic data have been sent the generic data response form. The type
of Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out the
forms. . . .
EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by the
registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency. . , ,
1 -
The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering-
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to Chief, Information Policy Branch,
Mail Code 2137, 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. " " ' '
239
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THE DATA CALL-
juct Specific Data Call-In
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[^FORMS: .Thisitem identifies,your company name, number and address.
ii ii 'iLiaiuiiiiiiiiiiiiiiaii iitii iiii; i
-'"' """Item' 2. ON gp-pj FORMS: This' item identifies fae case' number, case -name, EPA.
: ~ " :"::' : ' ::" ":: ^"^emical, number and chemical name.
Item, 3. ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
; issuance is date stamped.
Item 4. ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of
your response regarding any product that you believe may be covered by this Data
iCall-In.butthat 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.
i in in 11 n in HI
Item 5, ON BOTH FORMS: Check this item for each product registration you wish to
cancel vQlgnlnily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of that
" " ' "' " 'tequesl! Since this Data C"afl-In requires both generic and product specific data, you
musTc6mplete item 5 on both Data Call-In response forms. You do not need to
complete any item on the Requirements Status and Registrant's Response Forms.
tiMLi !H^^^^^^ :: e:
H^^^^^^ ' i;i!K
,iir :. CheckAis Item ifthe^ata^Call-Inis^fbr,
generic data' as indicated in Item 3 and you are eligible for a Generic Data Exemption
^^i;L^:i^L4i'':: ^:,^;^^lior the cjEemical Iis,te<| in I|e,ni 2 an,2,,uj|i,in,|||| subject prpduct. JBy electing this
''"""" ' ll" " " "fyou'agree to tfie terms and'coiidiKoils of a GenericData" Exemption as " ".
lained in the Data Call-in Notice.
,!ซ JK^VjOU ^e eligible for or claim a Generic Data^Exemgtipn, enter the EPA registration
Iii! i.1 'J^^iss3^?F.,9S sssl iss?!61?! ?o.H!x'e- ฐf ,!iง! ,a,5$!ye. ^5งr?I^?ni tn,al y..ฐu use,m, yฐur PTฐ^ucii-
'IJit^ jH^Jypically, if you purchase an EPA-registered product from one or more other producers
^'SSlCVXhOa with respect to the incorporated product, are in compliance with this and any other
Call-in Notice), and incorporate that product into all your products, you
it yourself, or use any unregistered product (regardless of the fact that some
are:
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suiiiiiiiiM^^^^^^^^^^^^ >iiiiii::Riiv!;raiiipi'a ifiiviiin iiiiuri-1< JปK it::~iv,!1 "MI- ,tx : <
THE DATA CALL-IN RESPONSE FORMS
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Item 6b. ON THE GENERIC DATA FORM: Check -this Item if the Data Call-In is for
-generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-In.' Attach the Requirements Status and Registrant's
ResgQnงeJForni that indicates how you.will satisfy thoserequirements.
i ,- . .'.-. i
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use '
product (MUP) for which you wish.to maintain registration, you must agree to satisfy
the data requirements by responding "yes." ,
ItemTb. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products .
You.should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
is identical to another product and you qualify for a data exemption. : You must provide the
EPA registration numbers of your source(s); do not complete the Requirements .Status and
Registrant's Response form. Examples of such products include repackaged products and
Special Local Needs (Section 24c) products which are identical to federally registered
products. , ' . . '
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option 7
(Waiver Request) for each study for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
241
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and P^duct Specific "Requirements Status and
.Registrant's Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-Li's as part of EPA's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act. If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic-
data have been sent the generic data response forms. The type of Data Call-In (generic or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use
waiver. Please read these instructions carefully before filling out. the forms.
EPA has developed these forms individually for each registrant, and has preprinted these forms
to include certain information unique to this chemical. DO NOT use these forms'for any other
active ingredient. . . . -
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant .before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2137, 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.
243
-------
Item 6. ON BOTH FORMS: This item identifies the code associated with the use pattern of
the pesticide. In the case of efficacy data (product specific requirement), the required
study only pertains to products which have the use sites and/or pests indicated. A
brief description of each code follows:
r ' - _
A Terrestrial food .
B Terrestrial feed '
C Terrestrial non-food .
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial . , .
G Aquatic non-food residential .
H Greenhouse food
I Greenhouse non-food crop
J Forestry . . '
K Residential
L Indoor food -
- M Indoor non-food
N Indoor medical . . -
O Indoor residential ;, /
Item?. ON BOTH FORMS: This item identifies the code assigned to me substance that
must be used .for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PA1/PA1RA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET.
IMP
DEGR
End-Use Product ,
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active Ingredient
Pure Active Ingredient ; ,
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active Ingredient Radiolabelled.
Pure Active Ingredient Radiolabelled ;
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient Specified
Typical End-Use Product and Metabolites .'.-..
Typical End-Use Product or Pure Active Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
Technical Grade Active Ingredient or Typical End-Use Product
Metabolites
Impurities .
Degradates .
245'
-------
to submit or provide the required data; if the required study is not submitted on
time, my product may be subject to suspension. I understand that other terms
under Option 3 in the Data Call-In Notice apply as well.
However, for Product Specific Data, I understand that this option is available
only for acute toxipity or certain efficacy data and only if the Agency indicates in an '
attachment to this Data Call-In Notice that my product is similar enough to another
product to qualify for this option. . ,
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an existing
study by the specified due date that has never before been submitted to EPA.
By indicating that I have chosen this option, I certify that this study meets all
the requirements pertaining to the conditions for submittai of existing data
outlined in the Data Call-in Notice and I have attached the needed supporting
information along with this response.
Options. !- ON BOTH FORMS: (Upgrading a Study) I will submit by the specified due /
date, or will cite data to upgrade a study that EPA has classified as partially '
acceptable and potentially upgradeable. By indicating that .1 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 (MRJD) that EPA has assigned to the data that I am
citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study)"'! 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. ,lf reviewed, I am providing
the Agency's classification of tire study.
.However, for Product. Specific Data, I am citing another registrant's study: I
understand that this option is available ONLY for acute toxicity or certain efficacy
data and ONLY if the cited study was conducted on my product, an identical product
or a product which the Agency has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number (s). If I
. . cite another registrant's data, I will submit completed "Certification With Respect To
Citation of Data" and "Data Matrix" forms.
FOR THE GENERIC DATA FORM ONLY: The following three options (Numbers 7,
8, and 9) are responses that apply only to the "Requirements Status and Registrant's
Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
'247 '.'''
-------
Item 13. ON BOTH FORMS: Enter the phone number of your company contact
NOTE: You may provide additional information that does not fit on this form in a signed.letter that accompanies this your response. For example, you may
wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these
249
-------
ill1'i!l!IIIIIIPIll|l|!l!I!l:^'''IJiiBlllllii: ,niii'Ki 'J illllllNi'.!W\Ililll'KlIZnilllS^liai'l'F'iHIIKilSiSlliiini1::!!<'K :illlillllllllllllllllT I"?.JiililHi'1"!A iiJili W VKATfr WIII il'7i"!l III!,tf ^ I'lillK'liaIpiliN!:1!!;!!,!!:!,fftttto ป'IiI1!!!!;;":,!!!!i!!biffDtfft Uililil1' ,iMifciW!'>,:. i'! ','',1111":',ซ ,'''.' fc i!',:f:,'." y . .>'.'
jljjIIPj, jMIjillRii:;;:!1!, IhillF, llll'lli1" n: W | At ill ,1 i (llllii;lli!!ซiPli|ili iPI'Pnpji'ljjpniPHjP'lilisJPPniiil'il J illPlinBP < HijjF'ji. iljllllllil|i;<;|iiW illlji! 'Illnniil! "W" 'SPP'''^^'..^'^^!!!!!!!!!.^''!!'1!'''!!!'!]!,[. IBtlf .1''' "BIB W Wjj II lilillliHUjlilllililllllll'l' WMM Ijllii. jlJIi niiHjIi I!1!!! ป! 'fffSHf^ '.jPli Vi,! W1 jflnWjjji U. i1 [ i'lSillllPlpHjiP'P' 'V; j;1:"'!!!.,: ปI!H'" '!*",,: i, " i!.: ,i ',,, n: ' '! ! '",' r .3 ',
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an effort to reduce the time, resources and number of animals needed to fulfill the acute
lifillli!', ซ'i| IKi,,"!ll| IIP',
date requirements for reregistration of ฃroducts containing the active ingredients 3,5,6-
jSvjII!!^ acid pricJpjDyj^^
ioxyethyl ester, me |Agency has batched"products which can be considered similar in terms of
lty. factors considered in the sorting process include each product's active and inert
(identity,,percent composition and biological activity), product form (liquid, paste,
|^^!iriff^!r'ฃ!|!pfi3J etc.), and labeling ^e.g., signal word, precautionary labeling, etc.).
-;;ฑฃฃ:::::,.: Using available information, batching has been accomplished by the process described in'the
.pw;;"'pr55eding paragraph. Notwithstanding the batching process, the Agency reserves the right to *
|^r;i!^I,"r^;! 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
battery of six acute toxicologjcal studies to represent all the products within that batch.
ii^ i Registrants have the potion pฃpartiฃipating with all or some other registrants of products in their
acule lexicological 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
'lp|!|ซ!!1l! 'llllllnillllOIIIKIIlKllllllin lilill'lllilllllllllllllllllllll'liH'llllllllllliBlillliiillllilllllilliiiiiSi 'li iiininiiiiliiiiiiii < i m i i liiiiii ui i iiu, i Hi A , , , : , ,
^registrant chooses to rely ^p^^revipusly submitted acute toxicity data, he or she may dp so
clata base is complete and V2idby today's standards (see the attached
ia^ the formulation tested is considered by EPA to be similar for acute toxicity,
i
tipn has not been,,งigjQificanfly altered since'submission and acceptance of the
3ata" fie^'trahte'may not slajpp'ort !Teir''p1ro'dljH'u'smg "data conducted on a product "
KBfrom a different batch.. TRB must approve any new or canceled formulations (that were presented
: to Ae Agency after the publication of the RES1'before data derived from them can be used to
ir .products in a batch. Regardless of whether new data is generated or existing data is
"jiireferenceH. registrants must clearly jgentiiy the test material by gpA Registration Number. If
IIIM^ iij t:ij:iiK^^^^^^^^^^^
!M31IHan....pne cpjiifljlential sMsSiSBJ-PJ^SsEBiyls ^ipSF)" exists for.a product, the registrant must
s formulation actually tested by identifying the corresponding'CSF.
"Ii ^H^^^^ ' ai!K^^^^^^ i;i ?jm 'i , :,i';i'v!!>;:' iป;< :*':; 11:' " ,.'1'<; ;
-------
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). If a registrant does not want to participate in a
batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not
to participate in a batch does not preclude other registrants in the batch from citing his or her
studies and offering to cost share (Option 3) those studies.
! , -'.' _
Table 1 displays the batches for the active ingredients 3,5,6-Trichloro-2-pyridinyloxyacetic acid
(triclopyr), the triethylamine salt of triclopyr and triclopyr, butoxyethyl ester.
Table 1. ''.'.-..'' .
Batch
1
Registration
Number
62719-40-
62719-70
62719-251
62719-258
OK9 1000900
Percent Active Ingredient
triclopyr, butoxy ethyl ester ...61.6%
triclopyr, butoxyethyl ester ; ...61.6%
triclopyr, butoxyethyl ester ' ... 61.6%
triclopyr, butoxyethyl ester . ...61.6%
triclopyr, butoxy ethyl ester . ...61.6%
Form
liquid
liquid
liquid
liquid
liquid
2
62719-67
62719-260
triclopyr, butoxyethyl ester ...16.5%
2,4-D butoxyethyl ester ...34.4%
triclopyr, butoxyethyl ester .. ... 16.5%
2,4-D butoxyethyl ester " ... 34.4%
liquid
liquid
3
62719-176
62719-177
triclopyr, butoxyethyl ester ...16.7%
triclopyr, butoxyethy ester ...16.7%
liquid
liquid
' ,
41
23 9-25 152
-. 239-2587
triclopyr, triethylamine salt / ... 0.70%
triclopyr, triethylamine salt ...0.70%
liquid/ "
aerosol
liquid
251
-------
!!!!!!!! SISES ? <:V"* ;I|T! ' ill1?'81';!!''Ji'lS1!. '"ii'if"''"';1 \^
iiSi*^ <<'>l(:i>;'i!:;::i!!:; '"::'. '',:;! ' .i:*!-!'" ''.ii':::
^^ .......
n
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|||||||||||ii|H^
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9
228-316
62719-75,
triclopyr, triethylamine salt ...15.2%
2,4-Dichlorophenoxyacetic acid,
dimethylamine salt ...34.2%
triclopyr, triethylamine salt , , ...15.2%
2,4-Dichlorophenoxyacetic acid,
dimethylamine salt ' ...34.2%
liquid
'i
liquid
10 -
62719-92
62719-232
triclopyr, triethylamine salt ...33.0%
clopyralid - _ , ' ... 12.1%
triclopyr, triethylamine salt ...33. 0%
clopyralid , ... 12.1%
liquid
liquid
Products in batch 4 may cite data conducted on products in batch 6. . ,
2Due to the formulation of reg. no. 239-2515, this product may not share a primary eye irritation
study with the other products in batch #4. . ;
Table 2 lists the products in the "No Batch" group. These products can not be batched because
they were not considered to be similar to other the products in terms of acute toxicity. The
registrant of this product is responsible for meeting the acute toxicity data requirements for it
individually. These products may not cite acute toxicity/ irritation data derived from any other'
products in this RED. The registrant may cite pre-existing data conducted on their individual
product (or data cited in this RED for the technical product) if it exists and it meets current
Agency standards. '
Table 2.
Registration
Number
Percent Active Ingredient
Product Type
228-317
triclopyr butoxyethyl ester '.'...-16.50%
isooctyl (2-ethylhexyl) ester of
2-methyl-4-chlorophenoxyacetic
acid .' ...56.14%
dicamba . ... 3.60%
liquid
253
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538-180
17545-8
62719-87
62719-91
62719-246
62719-248
triclopyr, triethylamine salt
2,4-dichlorophenoxyacetic acid,
salt
triclopyr, butoxyethyl ester
triclopyr
triclopyr, butoxyethyl ester
triclopyr, butoxyethyl ester
triclopyr, triethylamine salt
clopyralid, triethylamine salt
triclopyr, triethlamine salt
2,4-D, dimethylamine salt
... 0.076%
dimethylamine
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... 1.15%
... 61.6%
... 96%
... 35.3%
... 1.70%
... 0.57%
- ... 2.0%
... 4.5%
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Instructions for Completing the Confidential Statement of Foiinula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the. form are required. Following are basic instructions:
a. 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. All weights reported under item 7 must be in pounds per gallon for liquids and pounds
per cubic feet for solids. x
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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). v'
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure
active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the
40 CFR 158.175 instructions. An explanation must be provided if the proposed limits
are different man standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs.become
obsolete for that specific formulation. ,
257
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United States Environmental Protection Agency
Washington, D.G. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 1.5 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
Branch, PIVI-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460: and to the Office of
Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below:
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
.My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data. " , , ..... "'.-,' . ' ...'....'. -.,..
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form arid all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obsslete
Form Approved OMB No. 2070-OOSO
261
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration
and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send
comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE
Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the completed form to this address. .
Certification with Respect to Citation of Data
Applicants/Registrant's Name, Address, and Telephone Number
Active Ingredients) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158)
EPA Registration
Number/File Symbol
Date ' ' '
Product Name
NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label,-you do not need to
submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). ' "
n
I am responding to a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should
be used for this purpose). '
SECTION I: METHOD OF DATA SUPPORT (Check one method only)
I am using the cite-all method of support, and have included with this form
a list of companies sent offers of compensation (the Data Matrix form
should be used for this purpose). ,
I am using the selective method of support (or cite-all option
under the selective method), and have included with this .form a
completed list of data requirements (the Data Matrix form must be
used). .-",-
SECTION II: GENERAL OFFER TO PAY
[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements]
I I I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
SECTION III: CERTIFICATION
I certify that this application for registration, this form for reregistration, of this Data-Call-in response is supported by al.l data submitted or cited in the
application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-alloption or cite-all option under the selective method is
indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an identical or
substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data
requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and
uses. ,'-.' ^
' I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have
obtained the written permission of the original data submitter to cite that study. , , - ' .
I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the .original data
submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for
compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have
offered (I) to pay compensation to the extent required by sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FiFRA; and (ii) to commence negotiations to determine the
amount and terms of compensation, if any, to be paid for the use of the study.
I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in
accordance with sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such
evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with
FIFRA. , - . . ;/
1 certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Date -
Typed or Printed Name arid Title
EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
-------
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The following is a list of available documents 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 are available on our website at www.epa.gov/REDs, or
contact Dean Monos at (703)-3Q8-S074,
i
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 Triclopyr.
The following documents are part of the Administrative Record for 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
269
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