United States        Prevention, Pesticides     EPA 73Ŗ"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
 ĢS of exposure^ and practically non-toxic by inhalation (Toxicity Category IV) and
• • l! ;•?;:*!?iFaulŽ	'i^^^^^^.^.^]^?^ eye ^ta^c>Jl snidy triclopyr TEA
"S
; 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.
    S!	,*
                               Dietary Exposure/Risk
                               I    	   	,'

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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 oŖ 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
                 ^                                     	°f korafSwnfr products are less than those for
                                  agricultural or industrial use products.  No chronic residential or occupational
                         iiiJUiii I \ j" iiiiiiiiii'i!" i'ljiii'lil..;::!1'.!;,^ ĢJ^      lir^'i'liiilF1'!1 ^H? iPuoi	Sm "t T	i*1,!,;*.'!*'	'iir!,ģ,,, !,,.v:iĢiģ,i:	ii ••'•.! ,„•„,',„ i,1.	'I.	', '" „ģ' J ' „ ",. •  " "H. T   ]V,ģ*'V*f*Jti'**l'*vj.,M*j. _
  |iii;:i; im|.;r.ģ ^ I;; if-a;; ''Ji >i;' 1'r'i ^| |i: ^S^off^Ž?, are 'anticipated
   'i us: L!	Z'lil/'ilni nii%•!	: •,•::- • w r",';ģ>i:.:'.';v *:i SB^                                Because this work is ongoing, these unique
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               {• •;;"' • •'."'' :f ." • ••':§: FQiPA^ Summary^ and Findings
                                       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!°^*lŽ .P°™iS??i S^asi81^ °f toxicity for triclopyr and other substances or
               sif Ģ••'.. •-.;;.' • ::: /	.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^<^°Pyr ^.^ 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 degradation—actual
environmental concentrations would be less. Acute risks to fish were
calculated assuming direct application to shallow aquatic habitat, which is not
currently allowed—flowjng 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
eyewear—for 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.
                       7

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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:,..	°n 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-™';;^!: ;Ŗ i!;".^?8Jstration Division representative Dean Monos at (703) 308-8074.
    ' r-4	;-'	:fĨ' "' 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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 Ill IK
             comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
             You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
             §158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
             choose the second option, you must submit or cite the data for the five batches along with a
    W^'l'il	 .; (?^!^!?^8P:^^fflF^i^^^!3^ Jn 19 C?R. §158.175(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'ģ- :,,,6,  EPA'S  RE VIEWS—EPA 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
  ll-ift, 1 Wij,	'Ģ li-'iiJin
             . in*1;
              III!!""!*1

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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 Ŗ ;> . • ••;'•  •:'; =4> ................. .  . Ecolpgical Risk Mitigation  . ' ...............................  114
              —'"I ' ''';i.-.  , ' 5. ........   Ground Water ............... •- ............ ', ...... . ........  117
              S:;,;,11  ;:,' ;. ';';;, 6, L ..... ......... ..... Occupational Labeling Rationale .............. ' ......... , ...  117
              ģli ••>•• ........ - ": •• --''7.     Endangered Species Statement  ....... '...-.  ....... ,.::..... ......  121
              Ģili-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
                              ,     ,. ..... ......      ;Ģ Pse Patterns Subject to Reregistration  ....'... ! ' 134
                                                                            and.Studies
                                                                                                 ,
                                      Citations ConsidĢ,..gf..t§ 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

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       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

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                 .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

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                          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

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                   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.
ģ liilK.; r M i " in i I'1!
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    I               II III         II        II    I               I      I    I         .I'1', '   , "I '•'   "I  i .
        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                                     '      '      ''  ''. '.''•  :  °  ' ' .   "• '
                   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 §4 of FIFRA.  In addition, in light of the
 unaffected statutory deadlines with respect to  reregistration, the Agency will continue its ongoing
 reregistration program while it continues to determine how best to implement FQPA.      .

         This document presents the Agency's decision regarding the reregistration eligibility of the
 registered uses of 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.

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        	'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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           lilllr
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   !'*..,!,'  ^Common,Name;,,,,	  Triclopyr


   :Ģ     ^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| 'ģ, * h '%i|i|!|[|,j I.'ii if „ :i';;' ! ' f,,,' ''•''"]'' , /' in! • '„  , :, ,,, if,, i '" i;, |!,, i ' !ii!'!, i  '•':, •  ,'', ,,',!' ,,,/,' ', ! ,,i, i'1,, ģģ!  v^ f   ,'| ' t  ,
Ģ!!;.;i:i*', ['.'",'	Cherpical Family:   Pyridinyloxyacetic acids
     , ' , "i"1'.. i,'i!!l;.   ' .littilll1,,,!:' ,' • '"'i!. ģ,„''",-: ,<: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

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                             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

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        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                ,    '.-'.       •  °

  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 (
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              The toxicological data base on triclopyr is adequate and will support reregistration
       eligibility.
            	    I  .      ,             .          " 	   , . •ģ.. ,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.

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 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.

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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 §82-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
 §82-1 (b)] In non-rodents.
   ;:"ii,  ."   •:	'  '•  • • •, .'.,.,ni ,'•  ' ;:  . •  /:.  . • •   • "',",;., .     ••   ,; f - ;•' ,-. ••.  "; ... . •[ •    ••'•'.
   Ģ	.,"	,, ! ,	!  ,  ''M  •  • 	  '' '•  , '/ ,     .,  ;,, ,'. •'•. i   ;	  '-.. -  ': ',", •  .••..:•'	  I   .  '; .

               c.      Chronic Toxicity

  ••••;•  „;   ...• ...  '  .;  •Ŗ;  .      ' .  ' , •     ,,    ;.::;.; 3"

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        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 §83-1 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

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   F 1	iiiiiii	i,imp,"inini" iiiiiiKF'Hill'	iTjii	iiniiniK	i	:	11 Him	iiiiiiiiiiiii  	iiiri,gnui"'!"1; ttLtHtauK*nmm1'-vxn'mu1* ģ™Tiiici-!1111 <)• s;~•:•;• us11;• vwe WBR::;.Kģ ;;<:-f:* ;•' './',K	•,• ' ••
lililitlB	  i •. i 'i1;; i .I!- 'Jin;
'iiliiSii.' '"ill	tlV it ; ii"
iSii]  ;;  '',• , ,,' IM   V '• Si-',',  •;••', Ģ' _  i,	  i;iM,; ';"';,''',""," ./'r'	:;"i'l) "'1;, '" ' .''V*>'.';• l   ': ' :i:-,:.' ,: |; •! ',  •- ,  .;   •  ''''•, . ;
SB;;!!	i1,  •	:.'.•	! ,,"	•„ MS:;'.ģ.  :.".  ,..'.,.::: <.•,   •  ; ••.:.<.,,'• •.„,. • /• ,;,":  : .• .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 §83-1) 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,Ģ,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
ĢĢ:*•;• 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 ,,',ģ 'i,;.'Ģ!, ' V" ' ,' t;,;,, :ģ'  '  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 ,",'.. :;  \   ••* •:ģ 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'     "    '  '   '          '

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 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

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iiiiiii	i	'!	i	!?!	tm"	i	;mi:	n*:-	s	m	iif^w/fr"	P?	w	w:.	:	(I'^.i^r-	11	n*$ww	if	imw-wmi	Ģs	:!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, ,;;,„ģ: 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"  . Ģ  "   "' ,:	:,	,V,. V'1  '' '!'. "'!' I'  '." ...l'1.' I",-'',!'•' .. ,i:,,Ģil!   . !' : '      ' 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

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        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

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: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  "              '     '      '  _     •

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  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 14ą2 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|ea§ed,|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 , ;•; • ģ•.', .:•',''•. .., ' •  .:.'.;• ,- " - '..i '',!    <•:      :      '• i
       ••  ',	:.[•!,. •,',:.: i a.'   I  Reference Dose  „     	i    -„   ,	•
          TilHlf" !  'I "", '  " '	 . ,  r JJItl  'i	  „   n, ',i ;• ', :;,.'i,,ģ   , ,„'.  , ..i!1,1' >, ,„':"	 ,,!  "  ,i  ' "  l:; '• , ';  ,/ ',  ,   l\ .,       .      Ģ,
          	:":'  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

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       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    •     .    ••     • •      '-•••'

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           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 '   :,,  'ģ, 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.

   iĢei :• 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:  '. :'  • •  .,"•Ģ' •, 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).

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, 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                  •            .-

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J!'l! illiiKI! Id' "i
!!;' E, ' '":M
                                             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 can§* 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  -,	, • '',..  <;• .	   •..:'•<•,••:"*•	;';•!ģ,: -• i- ••<',.,•", •; .• ••, wv^n    	• ,
, .  I1.!;;,,   '••... •     . • ,  ,  .ĢV'.  . •!  • '       ,   ,
   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   .       •.•   , • .        •      ••
    =:!ģ  ^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%
§5 granular product is applied by broadcast.
," r  ii ...... i* •, „, ,,i,,ii,ii!'ii ..... ,!',  i1  ,; 'inn •"„ , , ,„ ; •' .-'  ,, • '"„• i,h •iiv  , ,,,'!'i  '• ••',:';••••,'••",!,  M ,,,„,!, i  •, .  •  , „ •"   / • v,ģ   • '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' ,;" „ Ģi! i j   ,„   ', m,'• ,, l|:' i'"  i   ," "  '•', irii1,""1 •  : / l;,, • \ r  ,'. •" '"v1 i  '.'	  {!;"ģ'   i .  „       ':'     •     i
        4.     Risk Characterization
   (ill!""i 1,    .     , 'V "  "1 :im\     , '    '  "	i;  	   ģ ' . ,': '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" "••::; ģi. 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'jiĢ; ' ; ,,  ,:;:  "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 •. '• •  ģ .'.,';/ '>• •"•"•< ,'. 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- '             .   ,          -  •'

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     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 'ģ  ,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, Ŗ99.5% 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.pģi^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

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  Table 7:  Avian Acute Oral Toxicity -Triclopyr Butoxyethyl Ester (BEE)
11 ! !!!„ v Ģ
Species
Vjģ "
t ' ^ , ģ"V "i( '
! ' i'i I"' i o ,i v i t.
Northern Bobwhite Quail
(Colinus virginianus)
Northern Bobwhite Quail
(Colinus virginiamis)
* AX ;
-, ,* ^ j. Ģ• ,
^ 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
ReqairetaĢnts
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

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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'

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 Table 11: Avian Reproduction - Triclopyr Acid
Species
hi
Northern Bobwhite Quail
(Colinus virginlanus)
Mallard Duck
(Anas platyrhynchus)
%AŖ
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<3wĢMuģ
R-eqairefflsnt? .
yes (core)
yes (core)
       Base.,,,'' ' 'ģ> /'"••-.
Acute oral LD50
Two-Generation Reproduction
Study Guideline (83-4)
\ x Badpoiat
i " 
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                            (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

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  Table 15: Freshwater Fish Acute Toxicity TricJopyr Acid
1 ' Species
Illlllll 	 l|l 	 11 II 1 > II IHtt
111 1 II II 1 ( f ĢJģ
ill 1 1 1 * ft f -t < ''I
	 1 |l| 1 11 11 I ģ 1Ģ
Rainbow trout
(Oncortynchus
myJdss)
Bluegillsunfish
(Lepomis
macrochinis)
%AX' :
v-.-".^^^ ,
•• _JĢ 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)
  !Ģ:   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 Ģ 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)
Ģ
132.9
i ToxicJiy -
Category
Practically
non-toxic
IjfiUDtoa.
Akfeor/Year
40346504
McCarty/1977
Mffls
Šsideline
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
LŖV ^
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-^ Ģ * ^ 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

       :;"':  ;''.•'•";    Ģ    ; ''• 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"°

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*tfhŖav$?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
. ($>3ģ;,ai)
6.70
8.80
11.00 •
5.90 ,
7.60
15.30
32^5 '
BCĢ 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  ,     . '      "        '..

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 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

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       [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 ;.. .:'.••  ''",;•,  ""ģ':,;:,  • .         "     •   .
  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

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         [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     .'       '         ,        '

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 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

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                     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  ,      •:;••.'.     •            .

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             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            §c ;  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                       •

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 (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  '        .   '

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 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   "    	 ,; ,..!Ģ!, 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

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"	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%tŽs.'W$pif^Ŗ^atthe pesticide has properties and characteristics similar to pesticides that are
 known to leach or have been detected in ground water; 2) movement of the parent or degradates
 7A$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 ~\
0Ŗ7$anl/g
,25-134 '/;
, ' ,nģI/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

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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' ',;;  .^Ģr,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

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       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

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                 ;, 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 •*
- ," , "" ' - AigĢaJA
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

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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||§s|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 LDĢ/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, !;

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  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
•EECģ/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

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  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 " , ,Ģ'•	 ,,   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
:Ŗ?^
,
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 '
:ģ. -
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

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 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-'ģt:'•'•;;••'$:-{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

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             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 ģ|';:::;;;,;j'*ji-;;" ;, JĢ "' (^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    	,  .     •    °
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;:' :", '' •'' ;" , : '*.

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       (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
WĢ?%1tf
Coftswaed..
•v .•
10
: w*Ģx
,,IAģ ,
($>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.aeĢ
&SaģB ;
Inseot*
0.26
Acute R
-------
               Table 41; Mammalian Acute RQ for Single Application of Triclopyr
Appf,
Rate
(lis
,Ģ^A>
9.0
6.0
3.185
1.5
%Body
Weight
Consymsd
10
10
10
10
J-J5ay
Ģ*
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"  •>•:'.. Ģ•.••,.ģ 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

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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

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                  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.
Ģ1 II:,
Site
	 II 	 h II , ' i" iljjlj * 0 <^™ •>' ',
' Method
AppSeatiOB/
ŖftŖfid!
/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. E8Cģ we bģjĢJ on one direct nppKrafcon to 6 indies of water. EEC "use rate in Ihs ae/A X 734 pbh
                                                     80

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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

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  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
($pģ 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	•:.*.•  	Ģ 	,,„„„,"	,	,   ,, 	' ,	 , ,„	  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::-,'  ,' /,; ••'  :>" •:;Ŗ(. '   "'  .' ;V\3v' .'•...'•' ';:••'ģ,  V./ģ'-.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:, „ Ģi"	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 ''. ' •.,'., :... /„![,ģ;;'  . , ,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 MHģ M *Ģi. ,t
Site
1 i1 s i in - ^ •* ',
<
"'>:'•
1 1 S f'l'vģ
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"
RaaĢff
$& 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|ģ( .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.QoŖ
$%&&•
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 . '



PĢft
$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>
A4jacĢtt
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-SĢnl-
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  . .     '   , '   !<|iiĢi,i!|i .'     '    '' iģ'i  . '.J  •   i, "" ,   Tģii" ",, '"  ,  .   ', " •  '' 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 aģtJ 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
TĢM 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"
; ,Ģ*)'
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
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Table 53: Acute RQs for Aquatic Plants for Triclopyr TEA
, -^i^ittantf&tteq^ ^
Application (Sib ae/A}
|f 	 Lli''l''lli 	 iisiivģp^hiinn i JWl! ^
	 I '" ģ*!

Pastures and Rangeland
(6.0 Ib ae/A)
Appi-
Method
ss " %-
Aerial
Test Species
algae or
diatom
duckweed
algae or
diatom
BCĢ
(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
&§\
<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

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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,
hedgĢa-ows, non-
agriculture
uncultivated
areas/soils (1.5 Ib
ae/A)
Aj>i>i;
Method
Aerial
, ,^est
Species
duckweed
algae or
diatom
>BCģ
1 {ppmae)
0.63
0.07
BO***
' H0BŖ '
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!,."!''"!
ģy' IBIK 	,i,V'
                                  .j'1	".;:;,ii",:|i!;::,:1i;iii!, at	in*•W'M.'U.K!	'i?w
I	I1: I: .Ŗ	I"'," !	'nl!!!!!
                                                 , ,'"•*,„'"'!'' ::: i i,i ,r" ••'!,,' .. I1!'
         11  .... piili'BI :r ,i'"!' . i:	-:, * /-ill'1 • ,   II,	fi',,,1  'I'i ":„	, i,:"!!,',;!„,,; It	I1 ' 	 '' ,:  ,'" M"	„;ģ ,|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 ..... '""   ''    , .....    ' ..... ...... 'Wģ' '  ' 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 •'.',.,'Ģ,',:•'"' ......  " '''-"I  ,: ' •&" '; : i; / "' '•,;•. '• • ,.( •!-'"'"':" ,{•.•;'.;  ' : "V; .'.'•'* ;•..'•' ^ *;.. '  ''I,  ;'     . '•, '  "  -1'1 \' •;•. "" ••'''•. ..;,'''' '
            Acute risk to mammals                          •
                  1 ," '• V • '„ ,  IN !, ]| : ''' ' "AIM  „, ' i  !| ''''"" 'i ģ'•' , ,; a v,,", ' n  , ''' "'  |, •, ,; ;!;"/, ;', , ' • ģ  '„,,  '  ': „, y'',ģ .|,'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' ;•;:>:•.;Ģ .}-:> -\> 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'.

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.  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 '';ģ • 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	?\
               I	jĢ
               &'
               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: -;  ," ' '	',;	 .  ' ,ģ ,       „     •, •   ,  ,  ,
                             „  ijKTlBl' ••" ,„  i .''  "', '„. "', .„ i*1 :ni n'1' •!,,!  ", i  'ģi,,i,"'::,!,:: ģ|:'," i  .,„::,' ,,,,•,;"", , ll,.'!,ii |ll,."|1|; :Ģ• .;, ' ;• ]| ;,:, ģ•  . 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 •   ģiii Kiiiinii  i; ,  * , Linn • •„ i •• i ,i f-	..,,.,	 -s, „ , i  ,,..	"^ 	  ,	  * -J  '
              tnchlprppyridinol (TCP), to leach to grpundwater from triclopyr TEA or
  ':   '•:';.ģ 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!§[•."•„ 1  ; iiiiil•-.' I.'"•', i i • iV•ģ',	,i,.Sill,'•""-,'>,l.'ģ• •"!•!•,":.If• 1	'M: J• '•!" 1 * : • i is1;* '•' •:•• ; •• •"''i'•;';'•.','.-<*'•'• <	'•'• M' ;''• "" ģS ''




                                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;  4§'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, , ,| .,,,', , .    , ,, • ģi;..,  ,, 	,  , ..„.,,", ,.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.

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 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 water—resulting 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,,.	„Ģ,,, .,„,	,, ,;,,,•!	:. ,,	.,	.,„,	, ...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*.	,.Ģ ,,	,i, , ,i.n	i„,:,„!:,. ife*•	., ,	 .„ , 	*	ri	,	  iSr.,	4: „... 	Ģ	  ' ,, * „       ,,,    , 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 §180.417(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 § 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 §180.41703): 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<3EsmĢnt/ " "" ' , ', ,
fQazretitC&mmodity Definition/
,„, - s " ' Tolejraaees Listed Under 4ĢCFR §Jm4I7fa}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 §180.417(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 ....... Ģ i;i1' ' ..... SIP ' ' t; ...... '. "<• : .................. :": .: w w in1.;1. Ģ ••cf.i'i."iĢ'ifcr*1:! • i "i;;" ti- ; :i^ •': ru? "Ģģ ' "• ..... ģ ' • ;i ..... •; ...... ' ••
*fflt->5fi'1' i'l 'J.. Codex Harmonization,' '.'.''..
i'l'iilR'
                ift
                                                                                    ft:1::
         ;i,Miģ  -:,   '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,'  , •Ģ   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 	„<"ģ 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, rĢ'"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 Ģn 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
               :Ŗ 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  " *!' Ģ„ ' '"  • '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! ģ"> J'lS'i:/;1':"'!1;;;  -,,..'. I '•,]'! 1 ,".,„! .".', ,  1,1.   ' Fi  "
    I             !iģ  •'!''  ' 'H;':^., •(<Ģ;•. •  ':	'••<•'A^r.'-.	•:••,',,•:.•."!••':'!>, ģ••: ;;-•;'••, 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

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 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,                                              ;   . _   .
   Ģ. or in or around animal premises,
   Ģ on plants grown for other than commercial or research purposes, such as residential lawns
   ģ 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.):    .
   ģ 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 ,"!ģ'"!',„ ..... 'i it "I.,,, ..... '.,! r,!|.i:i, .......... , ..... , ...... H,,.^,. .,.!,„.., ..... ., , ......... . ........ ,-. ..... ,i, • v . ...... ..... ,,.i IN. „,Ģ' ....... ...ujiiMir t, ģ„ ...... • -,,,\,' , :•: 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!!§e^, %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!ĢNiiiLiJ .....  ;!!!""'! ii* ':.„' ,i l'i+!!!llil'|i| n,,,i'ģ r,;11 , .lr'i"'i ' , .;: ....... v",,!,, • n ..... <,i;; ....... ; • ..... miEiivn .ģģ y.i •,,,,"n ,a,ii",, iiii 'hi. joum"1 "".'i1111:1:!!,,., ,!•" mi ..... in .................. :: ...... • o\ ..... inn|i,, '   „ III; „ i ,,/' ; , ,,|, ,,11,'j: , ' 'I!' iHIIHI'l n  ,' ' ģ ' 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 Ģ.il:l<: ģĢ"' ' 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	:,
          Ĩ!?; 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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                      Ģi"!	:	!!,,: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   „ ģ ..... ...... ..........  ........ ......  ..... ,  < , ,. ,„ ...... ........... .   I- ....... . . ............... .„ ..........   ,     . ,   ,„   .    '       i
   \:iii::*l' ........ ilvl't '•; , , 0,;^: : . •",'Ģ( 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? ^4°?^ 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 Ģ.[.,  i/ifi •" • "n.if i   n. ' aiiiy        i1"* * ,i.i • iihiiiiiiiiiiiiiiiir i.;|:iii	: ii'iiii,	i,., n1. ' n i	;i	iĢ! rrsM1 / '."Si. mil	„ vsi" a "is'iiin.. FJ ,.!.Ģ iu~	,ģĢ-.ģ,	,.,.	'in, i'	„, ,,,:i.,	, „•  I,, ,.

Illis;! ''iW* i,  ";,:' ;Directions,fbr,Use, under the heading "Entry Restrictions."
I'miiiiB ;';.'Ģ,;;'!tis tuiii- „.,:": • iBui!, *ii	i-\ut \":t ••' •	':" ifiiiiit i, ]• ..•.•i*.aiiiji	.,,. '•' ;•." . ,a	iy ,:••:.;	ti<.,i".j:wr:.Ml'iM,lr ',"Ģ" '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	'"' Ģ:-'"   '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   -

   ģ    "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

          ģ    "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';,

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 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

 Ģ    Volume - Use high flow rate nozzles to apply the highest practical spray
 volume. Nozzles with higher rated flows produce larger droplets.      (

 Ģ    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
 Ģ    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           '

 Ž    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,           .          ,                    .

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                       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

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         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

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                                          132

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VLAPPENDICES
      133

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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            ,                                   .
                I     Greenhouse non-food      .
                J     Forestry
  • •    •    •     K    Residential
                L    Indoor food                <                                "
                M   Indoor non-food
                N  .  Indoor medical
                O    Indoor residential

   3.  Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study.  This normally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.                                              -,
                                           175

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	'	•.	I-	:!.	,	>j	;,:„;	  '	          	GUIDE TO APPENDIX C
                CONTENTS OF BIBLIOGRAPHY. Thi§ ...... 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|lhlģģ ............ ''Ģ' ..... i. : : ......... ...... •:'• .......... • ...... ģ ............ 'Ģ' Ģ ............ ........... ......... • ........... ģ ...... •• '•'• ....... • ............ ........ ...... • ....... iwi*a ..... "iiiMi, ....... ....... li "i, i ....... , ..... "• MI, .',IINTIM,,IIII, , i ....... ,,MI ....... iki'im • ..... • 1,1,1, „ ģT ..... •  • ,,.,,.  ' '' '   ..........
                          have been considered, are included.
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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
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         J           :                              ^ _               .
   (4)   Volume Identification (Accession Numbers). The final element in the trailing
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        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

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lip'iiiiiii'pi11 .iiirhi in,,,! ipi", < i1,,: flip;" i,,,   , iiLUiiiij'a	i;  „ģ,', 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 '•[•'•, Ģi"\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 ģ iiii'll'in'N , „:!': ll'llll'l'lli' ,,J!!l|!!,l""",',,lil" ,"T i"il'. ..... iģ'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^; ....... Ŗf fģ)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"ģi l! i''.1'"'11' '" " 'ģ l|i!|1""iģ'1 'll1'" 'i" iilHilllfil! ' Ģ : ..... I!.' • ..... , \, ":',''• ill "tr ;! fl1  ifil'. I ',•ģ' ' "'! '.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
~Ž: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)

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                                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
           WCL—73014.  (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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    -   'jT'.   I"; "  rt"l''  ii; - '!'• "111- •:• '•     ""l'1"1 ..... ............ "' ..... "'*1"|1II"""C ..... + ..... ...... ' ........ < ..... <: ..... i"r*ll ..... fir i' p -' ...... ...... "i ••' ............ fi ..... ihi.j ..... '1111;S;Jii!!ll;'.1; , "..  I1.".;1;  ..'  .. •. ;  . ,•' :;,   '  ;
                   .....  ™-*™
             ,                                •   BIBLIOGRAPHY        ,"
iiiiii ........ 'iiiME ........ iiiitji:  •  i'iiij.r.i <<* :t > i. •• :•,• <"!ģ i : ...... rait                   i     i   i  i    i      i  i    in i    i        ••,     •  .•'.  .:  > •: '.'"'i* i :">ģ ••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.'''3ģ5,6Trichloro-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:Ģģ
            ,'" '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 ģv 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\vĢ	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, Ģ inii: ,1,111;-ir: . .UN	^i,ri,Mjiiirģ,	 	., ., 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        •,'„:"• •"",ģ Ģ• •  ,•.,,,  ',  , 	  .  ,,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.
               ;Ģii:: ,:„;! ;„ ::,, "i ..i	..; , ,Ģ•                                       i                  ,„;,'ģ,   ,,,!•,,,

             •'.";:.-"  '^-.^f.    ""                 "        194
  Iri'jiii: I 'iSi:	," ,;,i',J,!I'
iilVIliiL'!	I'i;,!HE'11:1- s ,„'ģģ  "
            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 iĢ;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
                      U.S.A. 19 p.
                                                      196
III,  ! I	'            , I,

In I in   I          '             i 'i                      i

-------
                                BIBLIOGRAPHY
MRID
CITATION
00151963 MUazzo, D.; Batchelder, T. (1981) Evaluation of Garlon 4 Formulation in the Aquatic
          Environment: Report No. ES-426, Unpublished study prepared by Dow Chemical
          U.S.A.  21 p.                   .        .         ,   '    '

00151965 Milazzo, D.; Batchelder, T. (1981) Environmental Screening of Chemicals: Garlon 4
          Triclopyr EB Ester: Report No. ES-427. Unpublished study prepared by Dow
      /'•   Chemical U.S.A. 26 p.

00151967 .Laskowski, D.,; Bidlack, H. (1984) Anaerobic Degradation of Triclopyr Butoxyethyl
          Ester: GH-C 1697.  Unpublished study prepared by Dow Chemical U.S.A. 40 P.

00153805 Van Beek, L.; Leegwater, D. (1981) Study on the Percutaneous Absorption of
          Triclopy by the Rabbit: Part II: Single Treatment of Intact Skin: Report No. V
      .    81.472/212062: Project No. B 81/2062,Unpublished study prepared by Netherlands
          Organization for Applied, Scientific Research (TNO). 8 P.
                                              /             .              '
00153807 Van Beek, L.; Leegwater, D. (1981) Study on the Percutaneous Absorption of
          Triclopyr by the Rabbit: Part I: Single Treatment of Abraded'Skin: Report No.
          V81.322: Project No. B81/1735. Unpublished study prepared by Netherlands
          Organization for Applied Scientific Research (TNO). 8 p.

 00154713 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 U. S. A. 37 p

40055702 Mendrala, A.; Dryzga, M. (1986) The Evaluation of Triclopyr in the Rat Hepatocyte
          Unscheduled DNA Synthesis Assay: Laboratory Project ID; HET K-0420.85-031.
          Unpublished study prepared by Dow Chemical U.S.A. 25 p.    '         ,

40107701 Eisenbrandt, D.; Firchau, H.; Wolfe, E,; et al. (1987) Triclopyr: 2-year Dietary .
          Chronic Toxicity-oncogeniciry Study in Fischer 344 Rats: Final Report: Laboratory
          Project No. HET K-042085-026. Unpublished study prepared,by Dow Chemical Co.
          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.
          (also jeferenced as # 00154713)
                                         197

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Ill III
fill
             MRID
                                              BIBLIOGRAPHY
CITATION
            403,46401 Wjldlffe International Ltd. (1976) Acute Oral LD50~Mallard Duck Triclopyr
                       technical Final Report: Project No. 103-156. Unpublished study, lip.

Sfi&oĢ.' ti'f '•• '^^^^^^^M&^^^kW^),	§i§toRay Pietary LC50--B°bwhite Quail Triclopyr'
||||ii|%;|',f;' • •; Kjit;:;; ""j$.|::|lPtaHBpB,'&°r!: 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'
?Ŗ?;	™';-	"f-:;-  *< ?•*Ģ'•< 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.

lar'^'^sr "\il V^PiloeOl''^^^''^.'^'^^'^;1 Ikeda.'^;'''^'"all	(1987) Jriclppyr:'22-month Oral Chronic     	'
^.MiiiS^'if.'; '. siiii '\	:;':^i;^FP^X,a!!^	O"nc°§5ni^ty Study  in^Mice.  Unpublished study prepared by The
                       Institute of^Environmental tpxicplogy.  1465 p.

|:|;;:;  !.^!:. T*7 ; 46l5|602	l;,Ding]edine^ J. (1985) TricMoipyr1 Aciid":' An Acute Contact Toxicity Study with Honey
•	.,	:•'"::'-:	:.;,:; ,; , |:;:;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
                       ProjectlD #35252. Unpublished  study prepared by Dow  Chemical U.S.A. in
                       coppefation with Analytical Bio-Chemistry Laboratories,  Inc.  68 p.

           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
                       14-Labeled Triclopyr: Project Identification GH-C 1931.  Unpublished study prepared
                       by Dow Chemical U.S.A. 43 p.
              I,1,            i III  i1        „             i'	<                |
                                                     198

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                                 BIBLIOGRAPHY

MRID                          CITATION
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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40557002  The Dow Chemical Co. (1988) Triclopyr Butoxyethyl Ester: Analysis and.
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40557003  The Dow Chemical Co. (1988) Triclopyr Butoxyethyl Ester: Physical.and Chemical
        ,   Characteristics. Unpublished study. 6 p.                         •

40557004  Wall, J.; Battjes, J.; Lomax, L. (1987) Triclopyr Butoxyethyl Ester, Technical: Acute
           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.
           Unpublished study prepared by The Dow Chemical Co.  12 p.       ,
                                         199

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 Ill 111
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             MRID                           CITATION
             40557008  Wall, J. (1987) Triclopyr Butoxyethyl Ester, Technical: Primary Dermal Irritation
                        Study in New Zealand White Rabbits: Laboratory Project Study ID: K-120085-006B.
                        Unpublished study prepared by The Dow Chemical Co. 10 p.

             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  Ŗ?88) Tnciopyr ^X1 ?ster^  Pro^ct Identity ^d Composition.
                        Unpublished study  52 p.

             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
                        Chemical U.S.A.  62 p.

             41019702  McCoy, K.; Gegel, B.; Schriber, C. (1988) Solubility of Triclopyr Butoxyethyl Ester
   ,. j;;;*;;'	*ģ*•••...' Ģ,];.':	'^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	  ••, ģģ,,,!",'. |.   'i1'1	-ģ  ,,i' • .    •  • •'„       >.    i  •

 fctliJiU.]! :; :4!|bo3pl"'"'^ (^^^.;^ij^ow^^i§tott,	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.

            41219104  Chakrabarti, A,; Gennrich, S. (1988) Attempted Determination of the Vapor Pressure
=i;.!::': t. •:*';: -.;,: ;,:;:i	••	 ' j	": '•  •,'" :\ of Tricippyr TEA Salt by the Knudsen-Effusion/ Weight Loss Method:' Prpj ect ID:
                             L §8-020173. ^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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                                 BIBLIOGRAPHY
MRID
CITATION
41219106  Martin, E.| Reading, T. (1987) Triclopyr; (3,5,6-Trichloro-pyridinyloxyacetic Acid):
           Dissociation Constant Determination: Project ID: GHC-1975. Unpublished study
           prepared by Dow Chemical U.S.A. 20 p.    ,         -  ..    •

41219108  Yackovich, P.; Lardie, T.; Miller, J. (1988) Determination of Radioactivity in •
           Rotational Crops Planted One Year Following Soil Treatment with carbon
           14-Labeled Triclopyr: Project ED: GH-C 1997.  Unpublished study prepared by Dow
           Chemical U.S.A. 40 p.

41219109.  Dingledine, J. (1985) Triclopyr BE Ester: An Acute Contact Toxicity Study with
           Honey Bees: Final Report: Project Study ID: 103-240. Unpublished study prepared
           by Wildlife International Ltd.  15 p.             •

41353001  Timchalk, C.; Dryzga, M.; Kastl, P. (1988) Triclopyr: Tissue Distribution and ;   . .
           Metabolism of Carbon 14-Labeled Triclopyr in Fischer 344 Rats: Lab Project '
           Number: K/42085/40. Unpublished study prepared by The Dow Chemical Co. 76 p.

41443302  Mizell, M.; Lomax, L, (1989) Garlon 3 A (Triclopyr as Triethylamine Salt): Acute
           Dermal Toxicity Study in New Zealand White Rabbits: Lab Project Number:
           M-003724-009D. Unpublished study prepared by The Dow Chemical Co. 20 p-

41443303  Nitschke, K.; Battjes, J.; Yano, B. (1989) XRM-3724: Acute Aerosol LC50 Study in
         ,  Fischer 344'Rats: Lab Project No: M-003724-010, Unpublished study prepared by
           The Dow Chemical Cp,  20 p.                                .                 .

41443304 '  Mizell, M. (1988) Garlon 3A (Triclopyr as Triethylamine Salt): Primary Eye Irritation
           Study in New Zealand White Rabbits: Lab Project Number: M-003724-009C.
           Unpublished study prepared by The Dow Chemical Co.  14 p.

41443305  Mizell, M. <1988) Garlon 3A (Triclopyr as Triethylamine Salt): Primary Dermal
      '.     Irritation Study in New Zealand White Rabbits: Lab Project No. M-003724-009B.
           Unpublished study prepared by the Dow Chemical Co. 12 p.

41443306  Mizell, M. (1989) Garlon;3A'(Triclopyr as Triethylamine Salt): Dermal Sensitization
           Potential in the Hartley Albino Guinea Pig: Lab Project Number: M-003724-009E:
           DR-0291-2256-005E1.  Unpublished  study prepared by The Dow Chemical Co.  14
           P-"    '     '.•.'.          .       .•:•'.    '•'.-••'
                                        201


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41688301  Breslin, W: (1990) Results of a Teratology Study on DOWCO 233 in the Rat: Lab
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41714304  Woodburn, K. (1989) The Aquatic Dissipation of Triclopyr in Lake Seminole,
           Georgia: Lab Project Number: GH-C 2093.  Unpublished study prepared by Dow
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41732201  Woodbum, K.; Batzer, P.; White, F.; et al. (1990) The Aqueous Photolysis of
           Triclopyr: Lab Project Number: GH-C 2434. Unpublished study prepared by
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41732202  Samson, Y.; Gollapudi, B. (1990) Evaluation of Triclopyr Butoxyethyl Ester
         •  (Triclopyr BEE) in the Ames SalmonellaMammalian-Microsome Bacterial
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417343 01  Weseloh, J.; Stockdale, G. (1990) A Study to Determine the Effects of Tricl opyr on
           Seed Germination and Seedling Emergence: Lab Project Number: GH-P 1475:
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               "           -                '      •      .   i     • •        '    '  '  •
41734303  Krause, R. (1990) Compatibility of Construction Materials Triclopyr EB Ester   .
          •Technical: Lot MM900411: Lab Project Number: GH-C 2428: 90066.  Unpublished
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41736302  Cowgill, U.; Milazzo, D.; Landenberger, B. (1988) A Comparison of the Effect of  •
           Triclopyr Triethylamine Salt (Garlon 3 A) on Two Species of Duckweed Examined
           For Seven-Day and Fourteen Day Period: Lab Project Number: ES-DR-0003-7070-2.
       '  , Unpublished study prepared by Dow Chemical Co. 49 p.

41736303  Cowgill, U.; Milazzo, D. (1989) Triclopyr Acid: Evaluation of The Five Day Toxicity
           to The  Green Alga Selenastrum Capricornutum: Lab Project Number:
           ES-DR-0040-8195-8: ES-2047. Unpublished Study prepared by The Dow Chemical
           Co.  15 p.                   ,;
                                        203

-------
      ..... i; ...... Hiss':1
till illE	',1, f-	i	IS	"")> 111!"
iSLISii"Ulfi'*!,Mf .
             •ģ:••; ...... ,,; .••, .,ģ
   "iH"! 1  ' i	 •"! .'!
   •••IT  Ii,1 ,' !l
             IVffilD
                           ' *ĢH'. T1
                                     •'I.!' . ,1", :-. ISTJ!, 1 ,i'r 'i'
                                      ,„     ,   ,, .
                                    CITATION
  4l73g304
":!,  •Illllii1!!1'; 'fl
                      ,<|i ;' ": IH/.,,;" ' in ' wiilitl!	
                                                             I ,1, I1" ', ,1 I In!'' i'llJI'l ''ll'l'll'' '.IS* ģ
                                       es,   ^'Wtoplij^	P-'i'eV'aL; (iŖ89)"JPhamacokinetics And Metabolism
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  I'! !!":. I1' AlnilliTI'i'l, Ji
              lllll!!ll|||l!P'!i,il!iii " in ililii 'i
             4!747i6l
             "" 111!,! I Vfl'.'(::"*i:
lllģ^     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
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             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 ŖuDS) 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
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             41902002  Campbell, S.; Lynn,S. (1991)' Triclopyr Bee: An Acute Oral Toxicity Study With the
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             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

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                                 BIBLIOGRAPHY
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41969901  Ward, T.; Boeri, R. (1991) Garlon 4 Herbicide: Acute Flow-through Toxicity to the
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41969903  Ward, T.; Boeri, R. (1991) Garlon 4 Herbicide: Acute Flow-through Shell Deposition
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41971601  Ward, T.; Boeri, R (1991) Triclopyr Bee: Acute Flow-Through Toxicity to the  Grass
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41971602  Ward, T.; Boeri, R. (1991) Triclopyr Bee: Acute Flow-Through Shell Deposition
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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
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          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
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          26 p.        '             '    ,       .
                                        205

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ii ill iii|liiiiiii in i liiiiii iiiiiiiiiii liinii ni
iHIIll i I	I i   I	
                                I III!  Ill Nil I I III  Illlll I III!Ill II
                                               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',!,: << """:!Ŗ[
 42090403   Hamilton, T. (1991) Response to Data Call-in Notice (August 14, 1991)
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'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.
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  	>p.                  '                 '                 '    	•'	':
               jli	1, '
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                1
> '''IByQ^i n1  ' II  i ill111!  i1      	  'i     i i	            "   III1'  ' I    '' V.'••'•.I ''':''-:- .'•  ',''
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                                        ..... Response to Phase 3 Submssion on  nethylammonium Triclopyr.
                                      iiii,M,fli ..... i: ,:ģiii,,iii! • I,, ya ........ ,.i. ..... .,; ..... I,,,,,. ............ .......... i, ...... „.„, .............. . ................. „„! ........ ... .......... ..i. ,, ......... .,.,!,. ...„. ........ ..„ ,; ................ ..,, , ................. . ..... i*,, „ „   ,' ......... ....... c r ,
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                            ••  ii
•llll .1111111!::Ģ Wl'liii.: '"'IS llflBii;
i'4IKJill!Ill1' ģ ililllil'lllllli!!,:	 I'llli ,11"!:'
                                             ,                                                     .
           '] - " liliNlii'llJ'lv - i"!'.iii| ..... i ..... ,"":,ĢĢ• ,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: '"•:!' ,1ģ1:!li!*l'!!|i!i,. ".i 'lAiHiN ''iv' L ,;:,",; * , , . „., ; "  , , , ' ,  , ,  '• j
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l^"fcv>.:
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                                                                                                        y'lS'l': 'Ŗ
                                                                                                         . 'i:  :L i.
                                                                                                                 ''''I!'
                                                                                                                  iil
   IH'Mllllil'illlll'Hllli!!'., illP'Vlll1!'
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                                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,
           Formulation Science and Technology Lab. 4 p.                     -

 42090418  Hamilton, T. (1991) Response to Data Call-in Notice (August 14, 1991). Butoxyethyl
           Triclopyr: Product Chemistry; Unpublished study prepared by DowElanco,
           Formulation Science and Technology Lab. 4, p.-

 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.,
           Analytical Sciences Lab. 9 p.

 42090421  Woodbur/i, K. (1991) Response  to Phase 3 Submission on Butoxyethyl Triclopyr.
           Aquatic Organism Accumulation. Unpublished study prepared by Dow Chemical
  ,         Co., Environmental Tox & Chem Res. Lab.  10 p.

 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..
           Lab.  16.p..                                                             •

 42090424  Peterson, J. (1991) Phase IV Reregistration Response for Butoxyethyl      ,
           Triclopyr...Residue.  Unpublished study prepared by DowElanco, North American
           Environmental Chemistry Lab. 23 p.     ,

 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
           Number: K-120085-012. Unpublished study prepared by Dow Chemical Co., Lake
           Jackson Research Centen  122 p.                           .
                                       -207

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 Iii	
                                                BIBLIOGRAPHY
                                                CITATION
             42339002  Puvanesarajah, V.; Stewart, R. (1992) Metabolism of carbon-14 Triclopyr in
                         L^                                Lab Project Number: 39438. Unpublished study
                         prepared by ABC Labs, Inc.  106 p.
             4211J8Q4 Hayeas, P. (1992) Response to Review of MRID 417322-01-Triclopyr
ŖE "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 ?ģ'' III''!ģI*''' iW1 •. i 'ii. '!ģ,i, ' In   Iliffl 111"'::'!ģ''! 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;	ģ •' -,- •.'.',' • :t, i;

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                                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:
          ES-2529. Unpublished study prepared by Malcolm Pirnie, Inc. 37 p.

42721102  Hughes, 1; Alexander, M. (1993) The Toxicity of Triclopyr Butoxyethyl Ester
          (Triclopyr BEE) to Naviculapelliculosa: Lab Project Number: ES-DR-0133-7242:  .,
          ES-2530. Unpublished study prepared by Malcolm Pirnie, Inc. 37 p.

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
        •  study prepared by DowElanco and  A&L Great Lakes Labs. 228 p.

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
          prepared by Xenos Labs. 40 p.                '

42784301  Gardner, R. (1993) 3,5,6-Trichloro-2-pyridinol: Method for Chicken Tissues and
          Eggs (Supp): Lab Project Number: 86105.02. Unpublished study-prepared by Xenos
          Labs, Inc. 37 p.
                                                   . f
42821301  Havens, P. (1993) Supplemental to MRID No. 41714304:  Additional Data for Lake
          Seminole Aquatic Dissipation Study: Lab Project Number: PLH062193.  Unpublished
          study prepared by DowElanco. 10 p.
                                        209

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                                              BIBLIOGRAPHY

                                              CITATION
             42884501  Wippdburn, K.; Rick, D.; Kirk, H. (1993) Triclopyr Bee: Acute 96-Hour
                       Flow-Through Toxicity to the Rainbow Trout, Oncorhynchus mykiss Walbaum: Lab
   ;! IS*:;	&• - :•; ,|||!:: ;S:::'!:;, Ŗffiie^,,Nu:inb?r:	PPCP;?.!5:?6.!^	Unpublished study prepared by The Environmental
                 *K.vX$l&Ŗs$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:*'i1ģ!$!v S^SI'f^"::i'-:^!yer> ""^' Co°lQy> 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
                       Labs, Inc.  555 p.
            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
:ģ!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
                  North American Environmental Chemistry Lab. 82 p.
   .'•.';^;;i' '43i?960i ..... f|i Schwab^ D. (19ģ^ Evaluating the Effects of .Jridopyr TEA on fee Germination,
        °       '    "
                        mergence, and Vegetatve Vigor of Non-Target Terrestrial Plants: Final Report: Lab
               -; ••^.•'•^ ...... ;; P^ectNumben ^40874. Unpublished ..... study prepared by ABC-Lab., Inc.  168 p.
                                                     ,T\C\
                                                      Ŗj J. \J
                                                   1-; .iilMr .:i',,;i I1 ,'vS1 ģ '''..',' "   :" 'i-- '	.h1 viiiiii.;, ,'i  „ r .|,
il'BnilliUi..,1'"..I	ITIIii'lilA;1;!.";!	'Hill, li j.'
                     l'i!,,[,''	 !;"!:,!„!! Ģ, ģ! Ji'i ! Jlilliniliiiiii'i	 !li.,i' 'I1 „ " ,* n ; r,;r .„

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                                 BIBLIOGRAPHY
 MRID
                       CITATION
 43217601
 Bryson, A. (1994) Triclopyr Butoxyethyl Ester: A Study of the Effect on Pregnancy
 of the Rabbit: Lab Project Number: DWC 650/643/931352. Unpublished study
 prepared by Huntingdon Research Centre Ltd.  153 p.
 43217602  Bryson, A. (1994) Triclopyr Triethylarnine Salt: A Study of the Effect on Pregnancy
           of the Rat: Lab Project Number: DWC 645/646/931358. Unpublished study prepared
           by Huntingdon Research Centre Ltd. 171 p.
 43217603
Bryson, A. (1994) Triclopyr Triethylamine Salt: A Study of the Effect on Pregnancy
of the Rabbit: Lab Project Number: 642/641/659/931914. Unpublished study
prepared by Huntingdon Research Centre Ltd. 181 p.
 43230201  Weinberg, J.; Hugo, J.; Martin, ML; et al. (1994) Evaluation of the Toxicity of
           Triclopyr Butoxyethyl Ester to the Early Life Stages of the Rainbow Trout,
           Oncorhynchus mykiss Walbaum: Lab Project Number: DR/013 3/7242:
           DECO/ES/2699. Unpublished study prepared by The Environmental Toxicology &
           Chemistry Research Lab.  47 p;
43442601
Weinberg, J.; Hugo, J.; Miller, J; (1994) Evaluation of the Acute Toxicity of Garlon 4
Herbicide to the Bluegill, Lepomis macrochirus Rafmesque: Lab Project Number:
DECO-ES-2854. Unpublished study prepared by The Dow Chemical Co. 25 p.  ''
43442602  Weinberg, J.; Hugo, J.; Miller, J. (1994) Evaluation of the Acute Toxicity of Garlon 4
           Herbicide to the Rainbow Trout, Oncorhynchus mykiss Walbaum: Lab Project
    •   •,    Number: DECO-ES-2853. Unpublished study prepared by The Dow Chemical Co
           25 p.
                                                . '    _                    . >.    - '  •- •
43545701  Vedula, U.; Breslin, W.; Kropscott, B.; et al. (1995) Triclopyr: Two-Generation
           Dietary Reproduction Study in Sprague-Dawley Rats: Lab Project Number:
           K-042085-048: K-042085-048P1: K-042085^048GO.  Unpublished study prepared by
           Dow Chemical Co. 1065 p.                   '

43650001  Schwab, D. (1995) Evaluating the Effects of Triclopyr BEE on the Seedling   -
        .   Emergence and Vegetative Vigor of Non-Target Terrestrial Plants: Lab Proj ect
           Numbers: 41964: RES94090. Unpublished study prepared by ABC Labs., Inc. 152 p.

43675801  Jones, K. (1995) Triclopyr Butoxyethyl Ester: A Study of the Effect on Pregnancy'of
           the Rat:. Lab Project Number:  DWC 644/932299: DWC 649/932299: DWC
                                        211


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                                BIBLIOGRAPHY
MRID
CITATION
           Triclopyr in a Northern USA Forest System:" MRID 43011601: Lab Project Number:
           GH-C 4074: RES94Q45/RES94046/RES94154. Unpublished study prepared by
           DowElanco's Global Environmental Chemistry Lab. 22 p.

44039302  Havens, P. (1995) Response to EPA Review EFGWB#92-0111:"Dispersal and
           Degradation of Triclopyr within a Canadian Boreal' Forest Ecosystem Following an
           Aerial Application of Garlon 4:"'MRID 41445001: Lab Project Number: GH-C  ".
           2314A. Unpublished study prepared by DowElanco Environmental Fate Lab. 15 p.

 44198101  Phillips, A.; Poletika, N.; Lindsay, D. (1996) Frozen Storage Stability of
           3,5,6-Trichloro-2-Methoxypyridine in.Soil Stored in Acetate Liners: Lab Project
           Number: ENV94015.01. Unpublished study prepared by DowElanco.  44 p.

44329901   Concha, M.; Kennard, L. (1997) Photodegradation of (2,6-(carbon 14))Triclopyr
 •          in/on Soil by Natural 'Sunlight: (Final Report): Lab Project Number: 647W-1: 647W:
           ENV 97064. Unpublished study prepared by PTRL West, Inc. 110 p..

44385901   Eisenbrandt, D. (1997) Triclopyr-Mechanism of Toxicity. Unpublished report
           prepared and submitted by DowElanco. •   ;  .

PP#1F2508  Petition submitted by DowElanco (1996) In support of tolerances for triclopyr on,
           grass forage and grass  hay. See also MRID 43 919900.

           Nelson, J.; Rekeweg, M.; Gragg, E.; Pierce R. (1997). Biological and Economic  ,
           Assessment of Benefits from use of Triclopyr, Herbicides for Vegetation Management.
         .  Unpublished report prepared and submitted by DowElanco.  138 p.
                                        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 § 158.70). When using the OECD protocols,
 they should be modified as appropriate .so'that the data generated by the study will satisfy the
 requirements of 40 CFR § 158. Normally, the Agency will not extend_deadlines for complying
 with data requirements .when the studies were not conducted in accordance with acceptable
 standards, the OECD protocols are available from OECD, 2001 L Street, N.W., Washington,
 D.C. 20036 (Telephone number 202-785-6323; Fax telephone 'number 202-785-0350).

   All new studies and proposed protocols submitted in response to  this Data Call-In Notice must
 be in accordance with Good Laboratory Practices [40 CFR Part 160].                '

 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
  111 IE iiiR/ijinii!!!11!1!!!'*!*11'" iģj"'i|!! si i •• "'*!!!!!!!i!:ģfi! !S^ HH^          '^HH^            'ii!!:::!!1!11'sjiiiici1 .pii!!1';""!!1 ""'i!!"!'!f!!!!""' ''fi!*1!11!!' 'I'!1*!1"11! *i I1*!' If15 f- ft •?•?! I1!!!!' *!' !l!!" Ĩ' • il*-!" !•	'ai>: il!!!!J!!! 'I1* ;ii'' -ii yjl1 '!"'ll|!>'r	!|l!' •" 1"''';'''l>;1''':>l ^"'•'• •''!''
  ; 'i| 'ijiijlljl'li'l J!|l|''UJ'li1 Jl "III,, <"t ji; •;; ff\ \ /igililif'ViEf liiiiii llllllllilllllll'illlFllllllllllillllllllllllllll      Hllllllllllllll Illiilllfllllllllllllllil'illllllllllllllI'lJUII! IliHHii" HI llllliiil'illlllilliHi'ln.'!!!'1:;1'!!!!! 'Jil !	! Till i!1 'BIHiUFlr 'ii,ig;Ullillill JllliUIII'l Fill.nil"!:!'!',! Ji"!, Siili a. Diflll1; ni!!liii"i"!i! nil il! IViHI'linllllJirH 'X'lllllllHĢ' V/t, 'i' "• i!ģmii!J!l! ,'IIIIHi1 <"' .'• I f. Ill, Nlllu	:< , 'f , ,1, •",;' > :'" -,!"':"!' "Hi'111,
              1, Generic Data Requirements
                                                                              I:,1!	lSHW};)|f!i*j,ii!r..i;il
                                                                                                         ••	."	III!,
                              II	Kill!	Klfti	BWSUM	VK.iii
                                                                                    ':|j!;i!,1lill',i;;i,,i1i:li,lll'1!'liJi!VJ!1;J
  ^Illlll	4IIIB'	     ^              ,    		S!W^^^^                                    	Itvli^i!^              'Hi^:,	Ŗ
              Two forms apply to generic data requirements, one or both of which must be used in
  =Ŗ::Ŗ=	iresjjpnding to tEe Agency, depending upon your response.  These two forms are the Data-Call-in
  —=~—	' 6Ģr,Ģ^^r.^ ffĢ^, Ģ^a +CQ r>^,,;m™^^ g——g ^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	Ŗ	;	||	Ŗ	H	^	^ T	
             .e Requirements Status and Registrant's Response Forms also must be submitted if you do not
ummu	Ģ'ii!'ģ||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
•iii in iii linn •
 ^^
     IIH
             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!".',	Mģ
  •':=          	^^^^.^..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^ [Ŗ *'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	!,,Ģ!	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!|lĢ 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
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 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	FĢfSBss^JĢi-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*	'"Ĩ	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            °                                    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
          ^.iĨe	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	•	"Ģ"Ģ	y	r11'	'"	Ģ	'""	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™^^^^^^        "ģ""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 \fģv 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
                                        I,1 „; 11	.iUtt'! 'Z ,„:';  i l	i, j: I!"!; -J •'!ģ" Wd Ģiiw "|:,M'- "n1: ;:•:!:;	is" T r,, •-,'- !ii
                                       i	r;i ,1,1! „ i^n' 11 ::L	iniiii' in ''rr1; niiJi in,, 'n^iniw      'in	iii'ji'
'i ....... If ti ,.:.'.
              ' Sill!
                          ! ...... .u1.!1.'iaiil'!;K'i::.,Ģ
	," i,JH	61, IBS;;,; -;' li j;,,!J ?;!! tillSlliiS Ir: V,V':' s??"!1* !	IS"' S!;;::i:!S \ ''•.,,";
               ill!!1!!
                             'lit

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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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           	^LĢSWBJH^ĢKMTWtfS	!iS^^^^^                	              '  '
            B •,' •K.wwjiuwjih'i	sis ''Siui!i|iii . i 'iftuMi	•,	IE..!	EEiitii1 EWC*	K.iu.^rwif awiĢa,:!ģf tw ai	tr i;:i	BII	ivii^^^^ • ģ• 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,<ģ
	i	i	Ģi™w(Ģ
    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 857°-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 pŖpŖf 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	Ģl	JIN I'	  	  IIII  .   	
 'tiiff&glstrant must also inform Ŗf>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"miŖ	me. reqiurecf'datei! in the specified time frame. In such cases,
i;™-,thŖ 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   °   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
                                        229

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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' '\§mfwģ'ifp,1: iiig jiil:	i; i ijiij Ģi iii; i j ąr 'ģ^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.
                Ĩ?!= 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.
	•	ģ;	•	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                            °
     :;::=";:•; 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
     '™ . ....... '.':"§JEf§i5Si'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 ģ• fģ'	-1 iii	' 't j	' i i: f ii>:	i • -i; '-vk • •I-B S:, •: iĢi';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	,.'': *'Ģ:" (>,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
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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
                                                     ir'"" f',;:"311
                                                       236
                                                                                                      ,', "i , H!,1.! "I	,,   '•,",• ''III1

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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

-------
                                               !1i"i"iiw^                                                   ':::' z ' ii"T"!::J^:Jil"''il,' ii:S
    ::iiiK
    ;uiiiia^^^^^^^^^^     	iiK^^^^
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                                   ^                                   ...... WOTfrf ..... ;:,
                                                                                         .
                                                         ciiiui! i Ģi;i t! i, u Ģ MI . :'. ( ii iir jii ifciwrt IL .......... n, ..... 1:0 in * , *ii WE iii/i ; IM , 1011 lii , ' i, > ,,iiii ..... ,„•: ' ;,:, : M . ' i ,. i,
                                                    THE DATA CALL-
                             juct Specific Data Call-In

                       IBiģ^^^^	SI 'i* JBffWtf, .I W^^^^^^^      '	I!!1!! VM t>	KtiftWKHii WlHt'H i' ,"!fc •!1"!' ' W: • 11 11, i", ,0 ;;i< ..'"•, r. •  :" , ;• '•; • ,	: ,

                                   [^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.

           ,!Ģ •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- °f ,!i§! ,a,5$!ye. ^5§r?I^?ni tn,al y..°u use,m, y°ur PT°^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:
.M'™,',::.'1'' " \:<:fiji
i1ii'i;:; s.:'"'
'•*i	i"'.::' WW:


                                                   suiiiiiiiiM^^^^^^^^^^^^      	>iiiiii::Riiv!;raiiipi'a	ifiiviiin	iiiiuri-1< JģK it::~iv,!1	"MI- ,tx : <
                                                   THE DATA CALL-IN RESPONSE FORMS
        •       !!!:!'

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               BIB!'!'1. A!"1;1',, i|	H't'f If* I"1
                                  iii:1 tj,i,: 1 1 ..'j, 'ģ:-;< :i!:- '
                                                         ivii:ii:i;ii^ ..... i ........ ilium : 't ueii lU:, iii 'iii'i' ...... n
                   Si V1? ;fI1'": 4''; "5	jiii '•:'.'  .V', ?; •:' .1": *? 1	H.

-------
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
           ResgQn§eJForni 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


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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	ģ'IiI1!!!!;;":,!!!!i!!biffDtfft Uililil1'	,iMifciW!'>,:. i'! ','',1111":',Ģ ,'''.' fc i!',:f:•,'.•" y• . •  .>••'.'
   jljjIIPj, jMIjillRii:;;:!1!, IhillF, llll'lli1" n: W | At ill ,1 i (llllii;lli!!ĢiPli|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!!! ģ! 'fffSHf^ '.jPli Vi,! W1 jflnWjjji U. i1 [ i'lSillllPlpHjiP'P' • 'V; j;1:"'!!!.,: ģI!H'" •'!*",,: i, •" i!.: ,i ',,, n: ' '! •! '",' r .3	',
i=^^^^^^^                              	QEJPJ^BMCm
lili;lJiJŖf3S^^	
       an effort to reduce the time, resources and number of animals needed to fulfill the acute
        lifillli!', Ģ'i|	IKi,,"!ll| IIP',
                     date requirements for reregistration of Ŗroducts 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'Ŗ!|!pfi3J	etc.), and labeling ^e.g., signal word, precautionary labeling, etc.).

-—;;ąŖŖ™:::::,.: 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 pŖpartiŖipating 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|!|Ģ!!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,,§igjQificanfly 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!!>;:' iģ•;< :*':; 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

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                       !!!!!!!!• SISES                                                                                                                                                                                                                       ? <:V"*   ;I|T!  '  ill1?'81';!!''Ji'lS1!.  '"ii'if"''"';1 \^
                       iiSi*^                                                                                                                                                                                                                         <<'>l(:i>;'i!:;::i!!:;  '"::'.  •'',:;!                   '  .i:*!-!'"  '•'.ii':::
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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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499-409
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%
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... 1.15%
... 61.6%
... 96%
... 35.3%
... 1.70%
... 0.57%
- ... 2.0%
... 4.5%
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solid/stick

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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

  .f.  Flashpoint must be in degrees Fahrenheit and flame extension in inches.
                -       '              -'              '                                  \
   g.       For all active ingredients, the EPA. Registration Numbers for the currently registered
           source products must be reported under column 12.                        ...

   h.       The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
           common names for .the trade names must be reported.

   i.     ,   For the active ingredients, the percent purity of the source products must be reported
           under column 10 and must be exactly the same as on the source product's label.
  j.        All the weights in columns 13.a. and 13.b.  must be in pounds, kilograms, or grams. In.
           no case will volumes be accepted. Do not mix English and metric system units (i.e.,
           pounds and kilograms).                                         v'

   k.       All the items under column 13.b.  must total 100 percent.

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   m.       The upper and lower certified limits for ail active and inert ingredients must follow the
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           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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               g
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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 AdobeŽ 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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