DECISION AND EMERGENCY ORDER SUSPENDING
REGISTRATIONS FOR THE FOREST,  RIGHTS-OF-WAY,
             AND PASTURE USES  OF
 2,4,5-TRICHLOROPHENOXYACETIC  ACID (2,4,5-T)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
           WASHINGTON,  D.  C.  20460
        Office of Pesticide Programs

              February 28, 1979

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                      Suspension Order


       [Registrations issued  underjthe  Federal,  Insecticide,

Fungicide,  and  Rodenticide Act (JJTI FRA\)  as  amended,  7 U.S.C.

Section  136 ej;. /  fj.s.cL*  )°f  all pesticide  products  containing!

2,4 , 5-Trichiorophenoxyacetic Acid ((2 , 4 , 5-TJ)  If or  forestry

usesj (including site preparation, conifer  release,  and brush

and  weed control),fri gh ts-of-way uses! (i ncludi ng  bru sh and

                i                 t* /
weed control), I and pasture usesl—  are  hereby suspended and

the  -sale,  distribution, or other movement  in commerce, and

the  use  of  all  such pesticide products  for the  foregoing

uses  is   rohibited,
                      	-y_V_*.^-=	=.	\
                      Douglas  Mi  Costle
                        Adrai nis tirator
       ;-:3 28  1979
D at e:
^/ Pasture is defined as  land producing  forage for  animal
consumption, harvested by  grazing, which has annual or
more  frequent cultivation,  seeding,  fertilization,  irrigation,
pesticide application, and  other similar practices  applied
to it.   Fencerows  enclosing pastures  are included  as part of
the pasture.

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          Decision and Emergency Order  Suspending
          Registrations for the Forest,
          Rights-of-way, and Pasture Uses  of
          2,4,5-Trichlorophenoxyacetic  Acid
                      C2,4,5-T)
1 *  INTRODUCTION

       During the past ten months,  the  Agency  has  been

gathering information about 2,4,5-T through its  Rebuttable

Presumption Against Registration J  RPAR) process  in order to

decide whether registration of this pesticide  should  be

continued-f 43 FR 17116, April 21,  1978) .   This review was

prompted by studies showing that 2,4,5-T and/or  its dioxin

                                                       */
contaminant, 2 , 3 , 7 , 8-tetrachlorodibenzo-p-dioxinr'{ TCDD) — ,

caused reproductive and oncogenic  effects  in test  animals.

During the public debate initiated  by  the  2,4,5-T  RPAR,  the

Agency received reports that women  living  in the vicinity of

Alsea, Oregon, had miscarriages shortly after  2,4,5-T was

sprayed in the forest areas where  they  reside.  The Agency

investigated the circumstances surrounding these reported
^/  Current methods for manufacturing  2,4,5-T  pro-
duce TCDD as a by-product of the  manufacturing process.
Although 2,4,5-T manufacturers  attempt to  remove  this
contaminant, TCDD cannot be completely removed.   An  EPA
contract laboratory has measured  the TCDD  content in 16
recently produced commercial samples of  technical grade
2,4,5-T from five different manufacturers.  The contractor
reported that the TCDD content  in these  samples  ranged from
not detectable to 0.025 ppm-^J limit of  detection:  0.01  ppm)
[excluding higher values that the contractor reported  as
doubtful] .  Therefo-re, because  TCDD is present as a  low-level
contaminant in commercial samples of 2,4,5-T,  references in
this document to "2,4,5-T" or the "pesticide product"  mean
2,4,5-T that is contaminated with TCDD.

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miscarriages  and  compared the frequency of miscarriage  in

the Alsea  area  with  comparable data from a control  area.

The Agency has  concluded that the use of 2,4,5-T over a

six-year period in the Alsea area was related to a  statisti-

cally significant  increase in the frequency of miscarriages

by women residents of  the area,  and that these miscarriages

occurred shortly  after the use of 2,4,5-T in the area where

these women lived.

       Based  on this  and other information detailed below,  I

am ordering several  emergency suspensions under FIFRA

Section 6(c).   These  emergency suspensions immediately

halt the distribution,  sale, and use of 2,4,5-T for forestry,

rights-of-way,  and pastures until the completion of  further
                            **/
administrative  proceedings.—   I am ordering emergency suspen-

sion of these uses because I find that they pose an "imminent

hazard" to humans  and  because I  also find that an "emergency"

exists because  there  is  not enough time to complete a

suspension hearing before the next spraying season.
^_/  Pasture is defined  as  land producing forage for  animal
consumption, harvested  by  grazing,  which has annual or more
frequent cultivation,  seeding,  fertilization, irrigation,
pesticide application  and  other similar practices applied  to
it.  Fencerows  enclosing pastures are included as part of
the pasture.
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II.  LEGAL AUTHORITY
     A.
       In order  to  obtain a registration for a pesticide



under the Federal Insecticide,  Fungicide, and Rodenticide



Act £ FIFRA)   [7.  U.S.C.  136 et seq.] ,  a manufacturer  must



demonstrate  that the  pesticide  satisfies the statutory



standard for registration.  That standard requires 1  among



other things) that  the  pesticide perform its intended



function without "unreasonable  adverse effects" on the



environment  [FIFRA  Section 3( c) f 5) ] .   "Unreasonable  adverse



effect on the environment" means "any unreasonable risk to



man or the environment,  taking  into account the economic,



social and environmental costs  and benefits of the use of



any pesticide"  [FIFRA Section ( bb) ] .  In effect, this



standard requires a finding that the benefits of  each use  of



the pesticide exceed  the risks  of the use.  The burden of



proving that a pesticide satisfies the registration  standard



rests with the registrant and continues for as long  as the



registration remains  in  effect  [En_vi.rj>nmj3ntaj. Defense Fund



v. Environmental_Protection Agency,  510 F.2d 1292 1297 I CADC,
                                                  J


1975) ; E_iivi££nine r^t a_l_Def_e£.§_ e_F_und v.  Env^r omn^ntal P r o t ect i on



Ag^ncjr, 465  F.2d 528,  532 I CADC, 1972) ] .  Under Section 6  of



FIFRA, the Administrator is required to cancel the registration,



or change the classification, of a pesticide whenever he



determines that  the pesticide no longer satisfies the



statutory standard  for  registration.



                             -3-

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     B.  Purpg s e and Standard fgr Suspending  a Pesticide







       The suspension provisions in Section ff(c)   of  the




statute give the Administrator authority to take  interim




action until completion of the time-consuming procedures




required to reach final cancellation decisions.   Under this




Section, the Administrator may suspend the registrations  of




a product and prohibit its distribution, sale, or  use during




cancellation proceedings upon a finding that  the  pesticide




poses an "imminent hazard" to humans or the environment.




"Imminent hazard" is defined by the statute to mean  that:







         The continued use of a pesticide during  the




         time required for cancellation proceedings




         would be likely to result in unreasonable




         adverse effects on the environment or will




         involve unreasonable hazard to the survival of




         a species declared endangered by the Secretary




         of the Interior under Public Law 94-135.









       As discussed above, "unreasonable adverse  effects




on the environment" means that the risks from use  of a




pesticide outweigh the benefits of its use.   Thus, in order




to find an imminent hazard, it is necessary to find  that  the




risks of use during the period likely to be required for




cancellation proceedings appear to outweigh the benefits.




The Administrator may not suspend a pesticide without







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having issued a notice of  his  intention to cancel  the




registration, or to change  the  classification, of  the




pesticide.







        Suspension is the Administrator's tool for  quickly




correcting  a situation which endangers public health.   The




courts have repeatedly held that "the function of  a  suspension




decision  is to make a preliminary assessment of evidenc.e,




and  probabilities, not an  ultimate resolution of difficult




issues" [Env.ir_onmen;ta 1_De_fens^e_Fund v. Environmental. Protgc-




ti.on_Ag_en££, supra, 510 F2d at  1298].  "It is enough if




there  is  a  .sub^sjbajiti^^l ii^iill0.0.^ [emphasis in original]




that serious harm will be  experienced during the year  or  two




required  in any realistic  proj ection of the administrative




. cancellation)  process" [E]lv^ronm£ri^a^_De_f_en£j3_Fund^	Jjic.! v.




Environmental Protection Agency, 510 F2d 1292, 1297, 1D.C.




Cir. 1975)  quoting from E nv i ££ n m eri t a 1_ D e_f e ns^e_ F un d _,	I_ n£ _•_  v .




Environmental Protection Agency, supra, 465 F2d 540-'. D.C.




Cir. 1972)].  Moreover, the registrant bears the burden of




proof  during a suspension  proceeding because, as indicated




above, the  burden of proof  under FIFRA always resides  with




the  proponent of registration  throughout the life  of a




registration.  I See, e.g.,  Erw^£onm^nta^_De_f£n^_Fund  v.




Environmental Protection Agency, 510 F2d at 1297;  E n v_i £ o nme n-




tal  Defense Fund v. Env^£onm£n^5ijL_Pr_oJb^£ti.£n_A^en£^, supra,




465  F2d at  532.)




                             -5-

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     C.   Types  of Suspension Proceedings







        In this  order, I have begun  emergency suspension




proceedings.   This is not the only  type  of  suspension




provided  in  FIFRA.  Section 6(c) provides  for two kinds




of suspension  proceedings:  ordinary  suspensions [FIFRA




Section 6(c)(2)]  and emergency  suspensions  [FIFRA Section




6(c)(3)].  I have chosen to discuss both  kinds of suspension




because the  procedures applicable to  each  action are inter-




twined  and because of the complexity  of  the suspension




provision as a  whole.







        (1)   Ordinary Suspensions







        The Administrator may begin  an ordinary suspension




when he finds  that action is required to prevent an "imminent




hazard."   An ordinary suspension is not  effective immediately;




instead,  the Administrator is required to  give registrants




notice  of  his  intent to suspend and to allow five days for




them to request a hearing.  Only a  registrant may request a




hearing.   If a  hearing is not requested within five days,




the suspension  order becomes final  and is  not reviewable by




a court.   If a  hearing is requested,  the Administrator is




required  to  convene an expedited proceeding at which other




interested persons can intervene.   The sole issue at a




hearing is whether an imminent hazard in fact exists.   The




procedures for  conducting the hearing, with limited exceptions







                             -6-

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discussed below,  parallel  the hearing procedures for  an




emergency suspension.   The Administrator decides whether  to




affirm his imminent  hazard determination at the conclusion




of the hearing;  if he  does,  he issues a suspension order.




This order is  accompanied  by a notice of intent to cancel




the registration, or to change the classification, of  a




pesticide (if  one has  not  previously been issued).  A  final




order on suspension  following a hearing is reviewable  in  the




Court of Appeals.







       (2)  Emergency  Suspensions







       Before  issuing  an emergency suspension order,  the




Administrator  is  required  to make two findings:  (1)  that




the pesticide  poses  an "imminent hazard" and (2) that  an




"emergency" exists.  An "emergency" exists when the situation




"does not permit  [the  Administrator] to hold a hearing




before suspending"  [FIFRA  Section 6(c)(3), 7 U.S.C. 136d(c)(3)]




The Agency interprets  this statutory provision to mean that,




if the threat  of  harm  to humans and to the environment is so




immediate that  the continuation of a pesticide use is  likely




to result in unreasonable  adverse effects - i.e. the  risks




outweigh the benefits  - during a suspension hearing,  the




registration of  any  product  for that use may be suspended
                           -7-

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           */
immediately— .

       An emergency suspension order  is  issued  without

prior notice to registrants and takes effect  immediately;

it remains in effect until the cancellation decision

if no expedited hearing is requested.  If  an  expedited

hearing is requested on the issue of  imminent hazard/ the

emergency order continues in effect until  the issuance  of  a

final suspension order. Registrants are  given five  days  to

request an expedited hearing.  The hearing stage  is to  begin

within five days of the Agency's receipt of the hearing

request.  Unlike the ordinary suspension situation/ no  party

other than the registrant and the Agency may  participate  in

the expedited hearing on the emergency order, except  to  file

briefs.  The procedures for conducting the hearing  are

otherwise the same as in an ordinary  suspension.  For both

types of suspension, the hearing is to be  conducted in

accordance with 5 U.S.C. Sections 554,.556, and 557 except that
^/  The term "emergency" is not defined by  FIFRA,  and  the
statute in the emergency suspension  section does  not
specifically require the Agency to balance  benefits against
health and environmental risk of pesticide  use.   An alter-
native reading would be that an emergency should  issue
whenever a risk could result from pesticide use during
the time for conducting a suspension hearing.  However,
for the purpose of this proceeding I have decided  to
consider the risks and benefits in ordering an emergency
suspension, just as I balance risks  and benefits  in
deciding whether to register a pesticide or to take the
pesticide off the market through a cancellation or ordinary
suspension order.  FIFRA is a risk/benefit  statute, and
I see no reason to depart from this  balancing test in
issuing emergency suspension orders.

                             -8-

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the presiding officer  need not be a certified hearing




examiner.  For  both  types  of  suspension, the presiding




officer shall have ten days from the conclusion of the




presentation of  evidence  to submit recommended findings  and




conclusions to  the Administrator.  The Administrator shall




then have seven  days to issue a final order on the issue of




suspension.







       FIFRA provides  for  a special appeal of an emergency




suspension order  to  the District Court.  If an administrative




hearing is requested,  an  emergency suspension order is




subject to immediate review in District Court by the regis-




trant or by other interested  persons with the registrant's




consent.  On the  other hand,  if no request for a hearing




before the Agency is made,  the emergency order becomes




final and is not  reviewable by any court [FIFRA Section




6(c)(2), 6(c)(3)] .   The District Court action may occur




simultaneously  with  the suspension proceeding before the




Administrator.







       The District  Court  reviews only whether the emergency




finding is supported.   The standard for review by the




District Court  is very narrow—whether the order of suspension




is "arbitrary,  capricious,  or an abuse of discretion, or




whether the order was  issued  in accordance with the procedures




established by  law"  [FIFRA Section 6(c)(4)].  If the District
                                — Q «

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 Court  finds  against  the  Agency,  it may stay the suspension




 order  until  completion  of the expedited suspension hearing.







        The District  Court order  may be appealed to the




 Appellate Court  by either the Agency or the registrant,




 depending on the outcome.  A final order on suspension,




 after  a hearing  before  the Agency, may be reviewed in the




 Court  of Appeals on  an  expedited basis even though related




 cancellation proceedings may not have been completed.







 III.   SUMMARY OF FINDINGS







     A.  Summary of  Findings on  Risks







        Numerous  studies  have clearly demonstrated that TCDD




 and/or 2,4,5-T contaminated with TCDDD can produce fetotoxic,




 teratogenic,  and carcinogenic effects in experimental animals




 which  have been  exposed  to these chemicals.  I find that




 the occurrence of these  effects  in test animals indicates




 that humans  who  are  exposed to TCDD and/or 2,4,5-T may




 experience comparable effects.







        A recent  epidemiological  study reported that women




 living in the vicinity of Alsea, Oregon { an area where




 2,4,5-T is used  for  forest management) , have a statistically




 significant  higher incidence of  spontaneous abortions




(miscarriages) than  women living in a control area.




 Specifically,  the study  shows that:







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       { 1)   The spontaneous abortion  index  for  the  Alsea




study area where 2,4,5-T is used is significiantly  higher




than the index for urban or rural control areas  where  there




is no known use of 2,4,5-T.







       C 2)   There is a significant increase  in  the  sponta-




neous abortion index in the study area relative  to  the




control area in the months of June and July:  this increase




follows by approximately two months a period  in  March  and




April when 2,4,5-T was used to control vegetation in the




forested areas in which these women live.







       (; 3)   Statistical analyses of these data  indicate that




there is a significant correlation between  the  amounts of




2,4,5-T used in the study area during the spraying  season




and the subsequent increase in the spontaneous  abortion




index in the study area.







       This relationship between exposure to  2,4,5-T




spraying and an increased incidence of miscarriages in




humans is not surprising.  This is the same  relationship




that has been demonstrated to exist in test  animals through




numerous animal studies.  While there are uncertainties




concerning the amount of 2,4,5-T and/or TCDD  to  which  the




study area women may have been exposed and  concerning  the




precise route I or routes)  of human exposure,  the statistically




significant incidence of miscarriages described  above  makes







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it reasonable for the Agency to conclude  that  these  women  in




the Alsea Study area were exposed  to  2,4,5-T.







       The Agency concludes that it is also  reasonable  to




assume that individuals may be exposed to  2,4,5-T and/or




TCDD who frequent or live in areas where  2,4,5-T is  used  in




ways and under conditions which may cause  them to experience




exposure opportunities qualitatively  similar to that experi-




enced by the Study area women.  The Agency has concluded




that 2,4,5-T use patterns involving exposure opportunities




qualitatively similar to  those experienced  by the Study




area women are the forestry, rights-of-way,  and pasture uses




of 2,4,5-T.  The Agency has identified pesticide applicators




and persons involved in pesticide  application  support




activities, and persons living in  or  frequenting areas  of




2,4,5-T use as the principal groups of individuals who  may




be exposed as a result of the forestry, rights-of-way,  and




pasture uses of 2,4,5-T.  Based upon  the  animal test data




and other information, including the  Alsea study, the Agency




has concluded that individuals exposed to  2,4,5-T and/or




TCDD may experience adverse reproductive  effects and cancer.




Accordingly, the Agency concludes  that it  is prudent to




regard individuals who may experience exposures qualitatively




similar to those experienced by the Study  area women as a




result of the forestry, rights-of-way, and pasture uses, as







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individuals who may suffer adverse reproductive effects  or




cancer as a result of these uses of 2,4,5-T.







     B .   Benefits of 2 , 4 , 5-T Use During the Cancellation




         Proceedings







       The suspended uses {. forestry, rights-of -way , and




pastures)  comprise about 74% of the estimated 9.3 million




pounds of 2,4,5-T used annually in the United States.




2,4,5-T controls a wide variety of weeds at relatively low




cost.







       I estimate that the economic impact of this suspension




action will be small.  This finding is based on several




considerations.  The inherent flexibility in the treatment




schedules permits delays in treatment during an estimated




two-year suspension period.  Alternative chemical, mechanical,




and manual control treatments are available and are being     ;




used.  The availability of these alternatives will minimize




the impacts of suspension on those acres which require




treatment during the suspension period.







     ( 1)
       The forestry use comprises 28% of 2,4,5-T use.




2,4,5-T's advantage is its ability to control a wide




sprectrum of weeds without damaging the treated trees
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       Forest managers take measures  to  control  weeds




on softwood forests on two major  occasions  during  the




approximately 50-year life of  a commercial  forest:   { 1)




the preparation stage designed to  clear  a  site of  poten-




tially damaging vegetation prior  to planting, and 1 2)




the release stage designed to  free young trees I  3  to 10




years old)  from weed and hardwood  competition in order




to promote extensive growth.







       I have found that the use  of 2,4,5-T is not  neces-




sary for site preparation.  2,4,5-T is used only 20% of  the




time.  Other chemicals, mechanical or manual  clearing




methods, or burning can be equally effective  in  giving




newly-planted trees the opportunity to grow.  The alternatives




are more expensive.  A two-year suspension  of 2,4,5-T use




for release treatments would have  no  serious  effect because




the treatments could be delayed for two  years without




impairing tree growth.  Alternatives  are generally  available




where weed growth makes treatment  necessary.  Finally, the




impact on consumers of wood products  is  likely to  be small.







     ( 3)   The Rights-of-Way Use







       2,4,5-T is used to control  woody  and herbaceous




plants on railroads, highways, electric  transmission




lines, and pipelines.  The rights-of-way use  covers 41%




of total 2,4,5-T usage.







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       Chemical, mechanical, and manual methods  of  con-
            r


trol are also used on rights-of-way acreage.   Use of



more than one method is common practice.  The  cost  of



2,4,5-T is less than chemical alternatives  for some



methods of application, more expensive  for  others.





       Many rights-of-way managers who  have  scheduled



2,4,5-T use during the suspension period  are likely to



postpone treatment entirely.  Managers  will  likely  use



alternatives when plant growth is rapid.  Even if all



acres were treated with alternatives, I estimate  that the



additional cost of treatment on rights-of-way  during



suspension would not have a significant impact on users'



revenues or operating costs.





     (. 4)   The Pa sture Us e





       Weed control in pastures is now  practiced  on only



about 1.0 million out of about 101 million  acres  of pasture-



land.  There are effective chemical and/or  mechanical



control alternatives for all weed species in all  regions.



The maj or result of suspension on pastureland  would be a



delay in treatment on much of the acreage scheduled for



treatment due to the inherent flexibility of decisions



whether to treat.  The economic impacts of  a two-year



suspension would be of little or no consequence.





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     C.  Summary of Findings on  Imminent  Hazard







    =Q 1)   The Forestry Use







       In order to find an imminent  hazard,  I  must  find




that the risks of use during the period likely to be




required for cancellation proceedings  appear to  outweigh




the benefits.  The Alsea study,  establishing a correla-




tion between use of 2,4,5-T in forest  management and




miscarriages in humans, coupled  with animal  studies  showing




similar effects, indicates that  there  is  a  substantial




likelihood that serious harm could result to persons  with




qualitatively similar exposures  from the  forestry use of




2,4,5-T.  Aerial application, a  major  forest treatment




method, may result in drift and  increased exposure  potential.




This hazard to human health clearly  outweighs  the benefits




of 2,4,5-T use during the cancellation period.   The  economic




impacts of suspension are small  because of  the flexibility




of treatment schedules and the availability  of alternatives.




Hence,  I find that an imminent hazard  exists for the  forestry




use of 2,4,5-T.







    1 2)   The Rights-of-Way Use







       For the reasons discussed below, the  use  patterns




of the rights-of-way use create  the  same, or greater,




potential for human exposure as  the  forestry use.   In broad




terms,  considerable exposure potential exists  due to  the







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large numbers of persons living near rights-of-way and  the




likelihood of drift from the widespread use of aerial




application.  Hence, the rights-of-way use results in a




hazard to human health which in my judgment outweighs the




corresponding benefits. Although rights-of-way is the




biggest 2,4,5-T use, a use moratorium during the cancellation




proceedings would not have a significant economic impact




because many rights-of-way managers are likely to postpone




treatment entirely during the suspension proceedings; if




they do treat, alternatives are available.  Therefore,  I




find that an imminent hazard exists for the rights-of-way




use during the cancellation proceedings.







     I 3)   The Pasture Use







       For the reasons discussed below, the application




of 2,4,5-T on pastures presents exposures qualitatively




similar to the forestry use, and hence the risk posed by




2,4,5-T use to human health is of concern.  The exposure




risk may be lower than for forests and rights-of-way.   The




principal application technique is spot spraying with




knapsack equipment, which has less drift potential than




aerial application. The benefits, however, are marginal at




most.  Weed control is practiced on less than 2% of pasture




acreage, showing the relative unimportance of chemical  or




other treatments.  Treatment can ordinarily be delayed  or







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dispensed with entirely.   In  any  case,  there are effective




chemical and/or mechanical  control  alternatives for all




species in all regions  of  the United States.  Thus, while




the risks to human health  from the  pasture use appear to be




lower than from the  rights-of-way and forest uses,  the




economic impact of two-year  suspension  of the pasture use is




of little or no consequence.   I find that an imminent hazard




exists for 2,4,5-T usage on  pastures because the risks




outweigh the benefits of use  during the cancellation




proceedings.







     D.  Summary of  Findings  on Emergency







       As previously discussed, I have  interpreted  the




statutory provision  on  emergency  suspensions [FIFRA Section




61 c) ( 3) ] to require  a preliminary balancing of risks against




benefits of use during  the  time for holding a suspension




hearing.  Hence, an  emergency finding involves two  issues:




I 1)  immediate intervention  is required  because there




is no time to hold a suspension hearing before the  next




period of pesticide  use; and  I 2)  the risks outweigh the




benefits during the  time for  holding the suspension hearing.




At the end of the suspension  proceeding, I have discretion




to affirm, modify, or reverse my  suspension order.







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     (1)   The Forestry Use







       There is not enough time to hold  a hearing  before




the next forest spraying season.  Much of the  year's




treatment generally occurs between March and May.   I am




advised that in some parts of the Pacific Northwest, spraying




is about to begin or has already begun.  Hence,  assuming




2,4.5-T use on forests poses unreasonable adverse  effects,




immediate action is required to stop 2,4,5-T use.







       The risks posed by 2,4,5-T forestry use clearly




outweigh the benefits of use during the  suspension  pro-




ceeding.  The Alsea epidemiological study suggests  that




persons in the vicinity of forest spray  are being  exposed  to




the potential dangers of 2,4,5-T use.  These people are




about to be exposed to almost one year's dose  of 2,4,5-T




applications in the next two months.  The emergency suspen-




sion proceeding is anticipated to run from March through




June I see discussion in Section V). Hence, by  the  time the




suspension hearing is over, it will be too late  to  halt much




of this year's spraying.







       Considering benefits, the economic consequences




from a three-month delay for the completion of suspension




proceedings are very small.  Much of the scheduled  treatment




can readily be deferred for this short a period  of  time.







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In any case, alternatives are generally available  to  prevent




reductions in tree growth where treatment  is considered




essential.







       Accordingly, I find that an emergency exists for  the




forestry uses of 2,4,5-T.  Therefore, I am ordering immediate




suspension of all 2,4,5-T registrations for these  uses of




2,4,5-T.







     ( 2)   Rights - o f-Way__U s e







       2,4,5-T is applied on rights-of-way I railways,




highways, electric transmission lines, and pipelines')




during the spring growing season, which starts  in  March  in




some parts of the country.  Additionally,  some  methods




of application on rights-of-way may be year-round. Hence,




there is not enough time to hold a hearing before  humans are




exposed to the risks to their health presented  by  this




chemical•







       The risks of 2,4,5-T use far outweigh the benefits




during the time for holding a suspension hearing.  The




potential for human exposure from the rights-of-way use




during this period is not inconsiderable even though




the use season is not limited to the March-June suspension




proceeding period.  Large numbers of people live near




rights-of-way areas, and aerial application is  an  important




application method.  On the other hand, little  economic







                           -20-

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harm will result from a three-month use moratorium.  Use  on




rights-of-way can generally be deferred for  this  short




period of time.  At any rate, alternatives are  available.




Chemical alternatives are cheaper than 2,4,5-T  for  some




application methods, including aerial application.




       Accordingly, I find that an emergency exists  for




the rights-of-way use of 2,4,5-T.  Therefore, I am  ordering




an immediate suspension of all 2,4,5-T registrations  for the




use of 2,4,5-T on rights-of-way.




    ( 3)   Pasture Use




       The application of 2,4,5-T to restrict weed  growth




on pastures is expected to occur in March in some parts




of the country and in even more areas before the  anticipated




completion of the suspension proceeding in June.  Hence,




emergency measures are required since I believe that  the




pasture use poses the risk of unreasonable adverse  effects




to human health during the suspension hearing.




       The pasture use presents the risk of  exposing  innocent




bystanders because residences are scattered  throughout




pastureland areas.  The risk to humans from  2,4,5-T  use  on




pastures may be lower than from use on forests  and  rights-of-way,




because aerial application is used on forests and rights-of-




way and not on pastureland. On the other hand,  the  benefits




                       -21-

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of use during the 3 to  4 month  suspension  period are

minimal.  Treatment can most  certainly  be postponed during

this short period.  In any  case,  there  are  effective

chemical and/or mechanical  control  alternatives for all weed

species in all regions of the  country.


       Accordingly, I find  that  an  emergency exists for the

pasture use of 2,4,5-T.  I  am  therefore ordering an immediate

suspension of all 2,4,5-T registrations for the use of

2,4,5-T on pastures.


IV.   BASIS FOR FINDINGS CONCERNING  IMMINENT HAZARD AND EMERGENCY



       In Section III of this  notice,  I have presented a

summary of my findings that an imminent hazard and emergency

exist for the forestry, pasture,  and  rights-of-way uses of

2,4,5-T.  The data, information,  and  analyses upon which

these findings are based are  detailed  below.
     A.  Fj.ndj.ngs Relating  to  Adverse  Ef^egt^.^n Test
         Animals

     C 1)  Adverse Reproductive  Effects  in  Tegt Animals
       This section presents  the  test  animal  data upon which

I relied in finding that exposure  to TCDD  and/or 2,4,5-T is

likely to result in adverse reproductive  effects in humans.

Except as specified below, these  data  were derived from

studies in which pregnant rodents  were orally exposed to


                           -22-

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TCDD and 2,4,5-T during the  second  trimester  of  gestation by




daily gavage or in which primates were  chronically  exposed




before mating.  T'he pregnant  rodents  were  sacrificed  shortly




before the scheduled birth of  the offspring,  and the  fetuses




were examined for abnormalities. The  Agency has  extracted




key data for presentation in  this report  of findings.




Experimental details and descriptions of  the  underlying data




are presented in the 2,4,5-T  RPAR notice  and  in  the published




1iterature.







      ( a)   Exposure of Test  Animals  to TCDD







       TCDD produces fetotoxic  effects  such as  death




and reduced fetal size; skeletal deformities  such as  cleft




palate and clubfoot; injury  to  internal organs  such as




intestinal bleeding, intestinal lesions,  and  abnormal




kidneys; and post-partum effects such as  reduced survival.




These effects appear in several different  rodent strains and




species, occur in all of the  litters  in some  dose groups,




and occur at doses at least  as  low  as 0.01 ug TCDD/kg.   The




repeated and regular appearance of  several different  forms




of damage to test animals of  several  different  strains  and species
                                 -23-

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indicates that  TCDD  is  a teratogenic and fetotoxic  agent  in




mammals.







       ( i)  Fetotoxic  and Embryolethal Ef_f_ects_







       Fetotoxic  and embryolethal effects have been  reported




for at least  three different mouse strains, two different




rat strains,  and  one strain of subhuman primates exposed  to




TCDD during gestation.   For example, in studies using




generally low-dose regimens of TCDD, Neubert and Dillmann




reported that resorption sites (resorbed or dead embryos)




occurred in 54%  (7/13)  of the litters at 0.3 ug/kg  and  in




100% (3/3) of the litters at 9.0 ug/kg for NMRI mice,




compared to 24-32% (23/95 and 24/65) of litters exhibiting




resorptions in  control  animals which had not been exposed to




TCDD.  Sparschu  et al.  reported resorption of 100%  (110/110)




of the fetuses  in Sprague-Dawley rats exposed to 8 ug




TCDD/kg, compared to 20% resorption (63/309) of the  fetuses




from the control  animals.   Khera and Ruddick reported  100%




(77/77) resorption of  fetuses at 4 ug/kg and 36% (56/153) at




exposures of  1  ug/kg in Wistar rats, compared to 2-7%  (3/152




and 10/127) in  the control  animals.   Smith et al. reported




resorptions in  95% (18/19)  of the litters of CF-1 mice




exposed to 1.0  ug/kg, compared to 74% (25/34) in the control




animals;  despite  the high control incidence of resorptions




in this study,  the increased incidence in the experimental




                       -24-

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animals was statistically significant.




       In an abstract of a current  study,  Schantz  et  al.




 1979)  reported 57% ( 4/7) of pregnant monkeys  aborted and




one delivered a stillbirth.  Two others  on  the 50-ppt diet




failed to conceive, and  two delivered normally.  The  eight




control animals all delivered  normal infants.   Maternal




toxicity was observed in some  dose  groups  in  some  of  these




studies.







       Similar effects have been reported  at  higher dose




levels of TCDD.  Neubert and Dillmann reported that a single




dose of 45 ug/kg to NMRI mice  on day 6 produced  resorptions




in 100% ( 3/3)  of the viable litters, compared  to resorptions




in 24% (23/95)  of the control  litters.   Courtney reported




an average of 87% mortality in 6 litters of CD-1 mice orally




exposed to 200 ug/kg, compared to an average  mortality of 6%




in 15 vehicle control litters.  This investigator  also




reported an average of 76% mortality in  6  litters  of  CD-1




mice exposed subcutaneously to 200  ug TCDD, compared  to  14%




in the six litters of control  animals.   Some  of  these




studies also describe statistically significant  weight




depression in the surviving embryos I e.g.,  Sparschu et al.) .







       These and other studies also report  that  TCDD  had  no




measureable adverse effects at some dose levels  in some




strains.  For example, Khera and Ruddick report  no fetotoxic




effects at 0.125 ug/kg in Wistar rats, and  Neubert and




                         -25-

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 Dillmann report no teratogenic  effects  at  0.3  ug/kg in  NMRI

 mice.  Courtney and Moore reported  that TCDD had  no effect

 on fetal weight or embryonic mortality  at  0.5  ug/kg in  CD

 rats/ and Sparschu et al. reported  no effect at  0.03 ug/kg

 in Sprague-Dawley rats.

        Dow Chemical Company, a  2,4,5-T  registrant,  has

 recently completed a study of the effects  of TCDD on repro-

 duction in Sprague-Dawley rats  exposed  to  low  dose-levels

 of this chemical for three generations.  The registrant

 concluded that "impairment of reproduction was clearly

 evident among rats ingesting 0.01 or 0.1 ug TCDD/kg per

 day.  Significant decreases were observed  in fertility,

 litter size, gestation survival, post-natal survival,

 and postnatal body weight."  In addition,  exposure  to

 0.001 ug TCDD/kg per day, the lowest level tested in this

 study, resulted in statistically significant increases  in

 the percentage of pups dead at  birth and/or dying before  the

                                                */
 end of three weeks of life in some  generations.—
 ^/  Dow Chemical Company has claimed  that  the  results
 of this study are "trade secret" or  "confidential."
 An injunction issued on April 4, 1978,  in  the  case of
 Dow ChjamicaJ^Co^ v. CojstJLje, Civil Action No. 76-10087,
 U.S.  District Court for the Eastern  District of  Michigan
=". Northern Division) , arguably precludes EPA from dis-
 closing the data from this study at  the present  time.
 Although the relevant provisions of  PIFRA  have since
 been amended to allow disclosure of  data such  as this
 [see,  e.g., FIFRA Sections 1ff.
-------
       Although  the  experimental protocols and strains




differ for  the  several  studies cited,  in each case TCDD




significantly increased the  incidence  of resorbed embryos or




stillborn animals  relative  to the rate observed in control




animals not  exposed  to  TCDD.   The regular occurrence of




embryonic death  in studies  by different investigators in




primates and in  different rodent strains indicates that




exposure to  TCDD during mammalian gestation may result in




the death of the embryos and related maternal reproductive




failure.







       { ii)   S|ke 1 etaj. Anomaj. ies







       Skeletal  defects appear in six  studies involving four




different mouse  strains.  Courtney and Moore report the




following incidences of cleft palate in the indicated




strains exposed  to 3 ug/kg  TCDD:  71%  ( 5/7)  in litters of




C57BL/6 mice, compared  to none 1 0/23)  in the controls; 22%




( 2/9)  in litters of  DBA/2 mice compared to none { 0/23)  in




the controls; and  30% ( 3/10)  for CD-1  mice, compared to none




( 0/9)  in the controls.   Neubert and Dillmann, also using 3 ug




TCDD/kg, reported  29% ( 7/24)  of the viable litters had




fetuses with cleft palate for NMRI mice compared to 6%




( 10/160)  of  the  control litters.  Smith et al. reported




cleft palate in  71%  I 10/14)  of CF-1 mouse litters at 3




ug/kg, compared  to none (0/34)  in the  controls.







                             -27-

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       In exposures  of  shorter  duration,  Moore et al.




reported cleft palate  in  86%  (12/14)  of C57BL/6 mouse




litters exposed on days  10-13  to  3  ug/kg,  compared to none




(0/27) in the control  litters.  Neubert and Dillmann reported




cleft palate in 71%  (10/14) of  litters  of  NMRI mice exposed




to a single 45 ug/kg dose on  day  11,  compared to 6% (6/95)




of litters in the controls.







       Courtney and Moore reported  no cleft palate in any of




the litters in CD rats  exposed  to 0.5 ug/kg.  Similarly,




Khera and Ruddick, using  Wistar rats, reported that the




occurrence of the skeletal  anomalies  in the fetuses exposed




to 2.0 ug/kg was comparable to  the  rate for the untreated




animals.







       (iii)  Injury to Internal  Organs







       Exposure to TCDD produced  injury to the kidneys and




intestinal tracts of at least  five  different mouse and rat




strains.  Smith et al.  reported 28% (4/14) of litters with




kidney anomalies at 3  ug/kg in  CF-1 mice,  compared to none




(0/34) in the controls.   Moore  et al. reported 100% (14/14)




of litters with kidney  anomalies  in C57BL/6 mice exposed to




3 ug/kg on days 10-13,  compared to  none (0/27) in the




control litters.  Courtney  and  Moore  reported kidney anomalies




in 100% (10/10) of the  litters  of CD-1  mice at 3 ug/kg,




compared to 33% (3/9)  in  the  controls,  and 67% (4/6) litters







                            -28-

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with abnormal  kidneys in the CD rat  at  0.5  ug/kg as compared




to none  (0/9)  in  the control litters.   Sparschu et al .




reported hemorrhages or lesions of the  intestine of 36%




(36/99)  of  the fetuses of Spr ague-Dawley  rats  exposed




to 0.5 ug/kg,  compared to none (0/246)  in the  control




fetuses .
        b )  Ex0 su reo fT e_s_t _ An .i m_a   t o
       Cleft  palate,  high incidences of  fetal  mortality,




reduced fetal weight,  and other indicators  of  injury to




the developing fetus  have been reported  in  several studies




in which  test animals  were exposed to  2,4,5-T  contaminated




with varying  levels  of dioxin.  Some of  these  effects have




been reported in  test  rodents at maternal doses  as low as 10




mg/kg 2,4,5-T containing no detectable TCDD (limit of




detection:  0.5 ppb) .




       For  example,  Neubert and Dillman  (1972)  studied the




effects of  2,4,5-T contaminated with dioxin in NMRI mice.




Using 2,4,5-T with 0.05 ppm TCDD, these  investigators




reported  resorptions  in 57% of the litters  and cleft palate




in 71% of the litters  at 60 mg 2,4,5-T/kg,  compared to




24-32% resporptions  and 6% cleft palate  in  the controls.







                          -29-

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       Similarly, Courtney  and  Moore I 1971)  reported that

oral exposure of CD  rats  to 80  mg/kg 2,4,5-T containing 0.5

ppm TCDD led to 52%  fetal mortality per litter, compared

to 3.4% in the controls.  At this  dose, kidney anomalies

were observed in 50%  of the litters, compared to none in

the controls, but none of the fetuses had cleft palate at

any dose.  However,  subcutaneous  injection of 100 mg/kg

2,4,5-T containing 0.05 ppm TCDD  led to cleft palate

in 40% of the litters of  CD-1 mice, compared to none in the

controls.


        The Dow Chemical  Company,  a 2,4,5-T registrant,

has recently completed a  study ' Smith et al. 1978)  of

the effects of 2,4,5-T I containing less than 0.5 ppb

TCDD)  on reproduction in  Sprague-Dawley rats exposed to

2,4,5-T for three generations.   The registrant reports

that exposure of these animals  to  10 and/or 30 mg 2,4,5-T/kg

per day resulted in  statistically  significant increases

in the frequency of  stillborn rat  pups, and/or decreased

                                           */
survival of the pups  that were  born alive.—
^_/  Dow Chemical Co. has  also  requested confidentiality
for the results of this study.   The  discussion in the
footnote in Section  IV. AiXiy.'fa) £ i)  also applies to these
data.
                             -30-

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       (c)  Other Effects  in  Test  Animals







       Recently, Highman  et  al.  showed that impaired




fetal kidney development  followed  maternal treatment with




120 mg/kg of 2,4,5-T  on days  6-14  of  gestation.   The im-




paired development was  associated  with a significant




reduction in cellular  alkaline  phosphatase.  TCDD




has been found to induce  delta  aminolevulenic acid syn-




thetase (ALA) in chick  embryos  with as little as 1.5 ng/egg,




and Goldstein et al.  found a  two-fold induction of ALA in




C57BL/6 mice as a significant 2,000-fold accumulation of




porphyrins in the liver occurred when compared to controls




after treatment with  25 ug/kg of TCDD.  Abnormal porphyrin




synthesis occurred in  female  rats  when treated in a chronic




study at 0.01 ug TCDD/kg  per  day (Kociba et al.  1977).




Alkaline phosphatase  and  gamma  glutamyl transferase levels




in female rats on 0.1  ug/kg  significantly increased when




compared to controls.







     (2)  Oncogenic Effects  in  Test Animals







       (a)  Exposure  of Test  Animals  to TCDD







       The Carcinogen  Assessment Group (CAG) has concluded




that TCDD induces carcinogenic  responses in mice and rats




at exceedingly low dose levels  and that these effects,




together with data showing that  TCDD  is mutagenic, con-




stitute substantial evidence  that  TCDD is likely to be




a human carcinogen.




                          -31-

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       Dow Chemical  Company,  a 2,4,5-T registrant/  studied




the effects  of  TCDD  on male and female Sprague-Dawley




rats exposed to 0.022, 0.220,  or 2.2 ppb TCDD.   CAG




agrees with  the registrant's  conclusion that there  is  a




statistically  significant increase in the incidence of




heapatocellular carcinoma in  female rats exposed to 2.2 ppb




TCDD.  In another  study using  Sprague-Dawley rats,  Van




Miller reported that 1 ppb and 5 ppb TCDD produced  a carcino-




genic response  in  the livers  of male Sprague-Dawley rats.  .




These observations tend to confirm the registrant's observa-




tions that TCDD produces an oncogenic response  in the  livers



                             */
of male Sprague-Dawley rats.—    Further, a preliminary




report of a  not-yet-completed  National Cancer Institute




study tends  to  confirm these  observations of a  carcinogenic




response in  rats.  A contractor for the National Cancer




Institute has  reported that TCDD is carcinogenic in the rats




and mice used  in that study.




       CAG also emphasized that, at low levels,  TCDD is




a potent inducer of  aryIhydrocarbon hydroxylase,  an enzyme




system that  contains an enzyme that is known to  mediate




the formation  of epoxides,  compounds which are  potentially




active carcinogenic  metabolites.
^_/  The CAG  and  an  EPA audit found that this study  had  major

shortcomings  in  design and conduct that limited the  reliability

of the data  developed  at  dose levels lower than 1 ppb.




                          -32-

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       GAG  also  reported that TCDD is mutagenic  in  the




Ames test without  the  metabolic activation system.   Its




mutagenic activity is  exhibited by frameshift mutations




caused by intercalation between base-pairs of DNA.







       (b)  Exposure of Test Animals to 2,4,5-T







       On the  basis  of its review of 10, chronic  toxicity




studies, eight using mice and two using rats, GAG has




concluded that there is no significant evidence  in  the




completed studies  that 2,4,5-T is carcinogenic in these




species.  Specifically, GAG  reported that exposure  to  3,  10,




or 30 mg 2,4,5-T/kg  (TCDD not detectable  at detection  limits




ranging from 0.12  to 0.33 ppb) does not have carcinogenic




effects in  Sprague-Dawley rats.  Preliminary data from  a  rat




study in progress  are  also negative.  Nonetheless,  these




findings do not  negate the cancer-causing potential  of




2,4,5-T as  commercially produced since it contains  the  TCDD




contaminant.







       CAG's review  of the design and conduct of other




studies disclosed  that testing in mice is inadequate




because the maximum  tolerated dose may not have  been used




in some of  the studies in which mice showed no carcino-




genic response,  and  because  there were significant  defects




in the design  and  execution  of a study for which the authors




                         -33-

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initially  reported a statistically significant  increase




in tumors  in  female mice.
     B •                tt °kt oHum an s
        ( a )   General  Discussion







        In  response  to the 2,4,5-T RPAR notice,  a  group




of eight women  informed the Agency that they  lived  within 12




miles of Alsea,  Oregon, where 2,4,5-T is used in  forest




management  and  that  they had experienced a total  of  13




miscarriages  between 1972 to 1977.  In their  letter,  the




women presented information showing that most of  their




miscarriages  occurred eight to ten weeks after  conception




and followed  by four or six weeks the date of the spring




application  of  2,4,5-T in the forest areas in which  these




women reside. The women indicated their belief  that  this




information  suggested that the unusually high number  of




miscarriages  in their group was related to the  use  of




2,4,5-T.




        The  effects which these women reported were  comparable




to the  embryolethal  and fetotoxic effects observed  in




test animals  that have been exposed to 2,4,5-T  and/or TCDD.




Moreover,  because embryos are particularly susceptible  to




the harmful  or  lethal effects of fetotoxic or teratogenic




agents  during the early stages of pregnancy, the  occurrence




of these miscarriages within approximately two  months of the use




                          -34-

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of 2,4,5-T in the Alsea area  suggested  a possible  relationship

between the use of the pesticide and  the miscarriages

reported for this group of women.   For  these  reasons,  the

Agency began an epidemiological study to determine  if  the

occurrence of the spontaneous abortions in  the  entire  Alsea

area\ parts of three counties comprising about  1,600 square

miles)  bore any relation to the use of  2,4,5-T  in  the

area. To answer this question, the  Agency gathered  informa-

tion and data from hospitals  on the occurrence  of  spontaneous

abortions in the Alsea Study  area and compared  these

data to comparable data from  a rural  area where  there  was

little or no known use of 2,4,5-T or  other  dioxin-contaminated

phenoxy herbicides I Control area) .  Data on spontaneous

abortions from an Urban area  near Alsea were  also  reviewed

for the study.

       The Agency's preliminary analysis of the  data generated

through this study indicates  that:

                                          */
       ( 1)   The spontaneous abortion  index— \ hospitalized

miscarriages per 1,000 births) for  the  Alsea  Study  area

where 2,4,5-T was used was significantly greater than  the

index for the Urban and Control areas where there  was  little

or no known use of 2,4,5-T;
^_/  The investigators determined the  spontaneous  abortion
index by relating the number of hospitalized  spontaneous
abortions to the number of live births, corresponding  to
month of conception.  The ratio derived in  this way  is
expressed as abortions/1,000 births,  related 'to month  of
conception, and permits comparison between  areas  of  different
total population size. The index is based on  a five-month
moving average for births to correspond with  monthly miscarriages
for terms up to 20 weeks£ about five  months) .

                           -35-

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        (2)  There  was  a dramatic increase in the spontaneous




abortion index for  the  Study area relative to the Urban  and




Control areas in the months  of June and July; this  increase




followed, by approximately  two months, a period in  March  and




April when 2,4,5-T  was  used  to control vegetation in  the




forested Study area; and







        (3)  Statistical anlyses of these data indicate




that there was a significant correlation between the  amounts




of 2,4,5-T used in  the  Study area during the spraying




season  and the subsequent  increase in the spontaneous




abortion index in  the  Study  area.







        In conclusion,  the  Agency's systematic survey  of




the occurrence of  spontaneous abortions in an area  of




2,4,5-T use indicates  that  there was an unusually high number




of spontaneous abortions in  the area, and that the  incidence




of spontaneous abortions may reasonably be related  to the




use of  2,4,5-T in  the  area.  The data further indicate that




the miscarriage experiences  which the eight Alsea women




reported to the Agency  were  representative of the experiences




of the  larger population of  women living in the Study area.




The data and information which provide the basis for  these




conclusions are summarized  below.




        (b)  Results  and Analysis




        Comparison  of the spontaneous abortion indices




for the Study, Urban,  and  Control areas for the period from




                         -36-

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1972 through  1977  shows  that  women living in the Study area




where 2,4,5-T is used  were  more  likely to experience




spontaneous abortions  than  women living in either the




Urban or Control areas (Table 1).   The six-year spontaneous




abortion index  averaged  80.8  for the Study area, compared to




averages of 43.8 and 65.4 for the  Urban and Control areas,




respectively.




       In addition  to  this  general elevation in the Study




area spontaneous abortion index,  there was a striking




increase in the Study  area  index for the months of June and




July.  During June, the  index in the Study area was 130.4,




compared to 44.9 and 46.0 in  the Urban and Control areas,




respectively.   For  July, the  indices were 105.4 for the




Study area, compared to  14.6  and 55.3 for the Urban and




Control areas,  respectively.  These data are presented




graphically in  Figure  A.




       The increased spontaneous abortion indices in the




Study area during June and  July  are particularly significant




when viewed in  terms of  data  on  the use of 2,4,5-T in the







                       -37-

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           * /
Study area.—   Spraying records  for  the  Alsea  area for  the

study period indicate that  2,4,5-T use occurs  primarily

between March 1 and April 30;  substantially  lower amounts of

the pesticide are used during  May and  still  lower amounts

are used during July and August £ Figure  B) .   Examination of

this information on the use of 2,4,5-T in  light  of data on

the increased incidence of  spontaneous abortions reveals
^_/  The preliminary report  inadvertently  included  3,530
pounds of silvex as 2,4,5-T in  the  estimates  of  usage  in
the Study area*  Conceptually,  this  flaw  is not  signifi-
cant:  1)  since its effect  would  merely modify  slightly
the very significant correlation  coefficient  between
herbicide use and miscarriages; 2)  the nature of the
relationship between time of  application  and  the mis-
carriages is expected to remain unchanged;  and  silvex
contains TCDD and could be  expected  to result in the same
effect.
    Nonetheless, the Agency immediately had the  analysis
rerun to determine whether  specific  change  in numerical
estimates result.
    Corrected 2,4,5-T use remained  significantly correla-
ted with miscarriages occurring 2-3  months  laterC r=.72;
p<.01) .  Combined silvex and  2,4,5-T spray  data  were also
correlated with miscarriages  since  both compounds  could
be hypothesized to cause the  observed effect  due to  a
common TCDD contaminant.  This  analysis also  showed  strong
correlation between use of  herbicides containing TCDD  and
miscarriages as would be expected on the  basis  of  animal
studies f r=.69; p<.02) .
    The relative insensitivity  of the correlation  to
changes in quantity further demonstrates  the  inherent
strength of the relationship  between the  basic  use pat-
tern and miscarriages occurring approximately 2  months
later.

                            -38-

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Table 1.  Monthly Spontaneous Abortion Index for the Study,
          Urban, and Control Areas  (Oregon, 1972-1977)_
Month | Study^ Area 1 Urban Area 1 Control Area
January
February
March
April
May
T«June
1
1 July
.... .,•*., . ., . _ .,
August
September
October
November
December
48.1
82.2
93.8
61.9
89.9
130.4"
105.4
88.1
46.0
76.2
76.7
70.3

73.9
49.3
43.9
47.0
50.8
r~ 44.9
14.6
r
31.8
49.6
54.8
19.6
45.6

lAverage I 80.8 I 43.8
1 1
82.0
28.1
48.1
97.5
63.2
46.0
55.3
79.8
85.3
50.5
54.3
94.5

Average 1
1
68.0
53.2
61.9
68.8
68.0
73.8 f
1
58.4 I
66.6
60.3
60.5
50.2
70.1

65.4 I 63". 3 Tl
- " - - | |
                            -39-

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Figure A.  Plot of Monthly Spontaneous  Abortion Index for

               the Study, Urban,  and  Control Areas
 130



 120




 110



 100



  90


x

£ so
c
H

c 70
O


t! 60
o
ja

* 50



  40



  30



  20




  10 -
                                         » .  •  Study Area


                                         o~—-e>  Urban Area


                                         A—_>  Control Area
              A
               tt)
              fc,
                  M
                  «
                  £
e   ^
9   y
                               Month
Q,
V
o
o
>   o
O   4)
Z   Q
                                 -40-

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Figure B.  Pounds of 2,4,5-T Sprayed in Alsea Basin
               Accumulated by Respective Month, 1972 through 1977,
               Compared with Abortion Index for the Same Period
                                         Pounds Sprayed
130 -
1A M
20

110 -

100 .

90
X
-S 80 -
c
H
c 70 .
O
•H
tJ 60 .
O
A
* 50 -

40 -


30 -
20
10 -








/A
/
/
/
/

/
;







\
\
\
\
\
V











^






i
/
i
i
i
i









i

,
/
/














\
\
\
\
\














iriii
C J3 M M > C ^






^
\

\
N
\
\
\
\
\
\

- Acortion inaex








/
/
f

\!
r





,-n








- 5


0
o
o
!-<
- 4 x
4J
C
0)
J
OJ
tive Ingredi
o
rt;
- 2 ««
0
in
c
3
0
1

~T 1 I I r
•I O> 0* -P > °
3 < to O Z O
                             Month
                               -41-

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that this increase  occurs  approximately two months after the




period of annual  application of  2,4,5-T in the Alsea area.







       More refined analysis of  these data on total abortions




and total 2,4,5-T use  by month during the period from 1972




to 1977 indicates that there was a statistically significant




correlation between the abortion index in the Study area




and the amount of 2,4,5-T  used there.  That is, when the




increased spontaneous  abortion index was compared to the




amount of 2,4,5-T used each  month in the areas where the




women resided, the  peak in the abortion index followed the




peak in the spray pattern  by approximately two months. This




two-month lag time  corresponds to the time predicted on the




basis of the initial reports from the eight Alsea women.




Because this correlation is  statistically significant




(p<0.01), there is  strong  reason to suspect that the sponta-




neous abortion increase was  related to the use of 2,4,5-T.




       In view of the  laboratory data establishing that




2,4,5-T and its contaminant  TCDD have embryolethal effects




in test animals and the susceptibility of the young embryo




to fetotoxic and teratogenic agents,  the increased spontaneous




abortion index in an area  of 2,4,5-T use may reasonably be




interpreted to be a consequence  of the exposure of women




residents of the area  to the 2,4,5-T used for forest







                         -42-

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           * /
management.—'
      ( 2 )  MS.X^^.E—Li^iZ.J __ and Vietnam


        ( a )
       On July  10,  1976,  an accident at the ICMESA chemical

plant in the Seveso  region of  Italy released 2 to 10 pounds

of TCDD over a  wide  area.   Hundreds of animals died, many

area residents  reported  skin disorders, and an area of

110 hectares was  evacuated.   The most pertinent reports on

this incident are provided by  Reggiani (1977), Tuchman-Duplessis

(1977), and Whiteside  (1977;  1978).


      There is  an apparent consensus that the reproductive

epidemiology of Seveso,  as presented, does not provide

firm evidence of  increased risk of spontaneous abortions or

congenital malformations  following the explosion.  The
^/  The Alsea  experience  may  not be an isolated incident.
Reports of people  adversely  affected by exposure to phenoxy
herbicides and/or  TCDD  have  frequently appeared in medical
and scientific  journals.   Recent summaries appear in IARC,
NRCC, and U.S.  Air  Force  documents on phenoxy herbicides  and
dioxins.  Further,  as  a result of the 2,4,5-T RPAR, the
Agency recently  received  numerous accounts of human health
effects attributed  to phenoxy herbicides and/or TCDD.  These
have been summarized in a document included in the record.
The cumulative  effect of  these reported incidents suggests
that people who  live and/or work in areas of 2,4,5-T use  may
experience adverse  health effects.

                            -43-

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Agency does  not  believe,  however, that those investigations



provide sufficient  evidence of the .at!j3e_n£e_ of  increased




teratogenic  risk  in humans, either for dioxin  in  general  or




among the women  of  Seveso in particular.  There are  three




reasons for  this  conclusion:  (1) deficiencies in the




available data;  (2)  methodologic deficiencies  in  the treatment




and interpretation  of  the data which are available;  and




(3) suggestive indications in the available data  that  there




may actually have been an increase in teratogenic risk in




the area after the  incident.




      Major  points  which  illustrate deficiencies  in  the




available data include:   reproductive data in  the area




"either do not exist or  are deliberately underreported"




(Reggiani 1977);  baseline rates for spontaneous abortions




and congenital malformations in the area prior to the




incident are not  available; less than complete cooperation




was obtained from local physcians and less than complete




registration of  pregnant  women was attained (623  pregnant




women were registered,  but 2,513 deliveries were  recorded in the




area for July  1976  to  May 1977; registration was  thus  about




25%); while  34 women obtained therapeutic abortions  in the




area, it is  estimated  that more than 2 times that number




obtained them  legally  or  illegally elsewhere (Whiteside




estimates the  number to  be 4 times as many); and  the




conventional pitfalls  of  reproductive epidemiology could  not




                           -44-

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be avoided 1 e.g./  dependence  on hoj3p_i^eQ^£e_d^ spontaneous



abortions for numerators  and  hcsataizd births for
denominators and  different  gestational cohorts for spontaneous



abortions and births  occurring in the same calendar period)  .





       Major points which  illustrate methodologic deficiencies



in the treatment  and  interpretation of the available data



include:  estimates of  the  total amount of dioxin released



ranged from 650 g ^Reggiani 1977)  to 11 kg fcwhiteside) , to



130 kg=>Na_tur_e  11/28/76) ;  estimates of exposure per person


                   2                                   2
varied from 29  ug/m   ( Tuchman-Duplessi s)  -to 5,620 ug/m



( Reggiani 1977)  ;  exposure  was characterized by geographic



           reproductive data were gathered by geographic



     vict^ raising questions whether the zones were contiguous



with the districts; spontaneous abortion rates were grouped



in 6-month intervals, but  congenital malformation rates for



1976 were grouped in  12-month intervals which could have



masked an effect  expected  to be relatively acute or with a



2-3 month lag period; and  the rates listed as "totals" for



the two groups  of districts in Table 13 ( ^n Reggiani 1977)



appear to be .avejr^ge^s of the district rates and as such are



invalid and cannot be interpreted;  the lack of chromosomal



abnormalities in  the  products of therapeutic abortions is



overemphasized  since  dioxin could conceivably produce a



teratogenic effect without  producing a concomitant mutagenic





                           -45-

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effect;  and  the  wide  interspecies variation seen in .I
 studies  should  not automatically be applied to teratogenic




 effects  because it is  known that very low doses are teratogenic




 in  the rat I e.g.,  0.01  ug/kg)  and dioxin doses which caused




 teratogenic  effects in  rhesus monkeys were apparently as low




 as  2.5,  50,  and 500 nanograms/kg.




       Suggestive  indications of a possible teratogenic




 effect in humans,  from  the available data, includes the




 congenital malformation rate increased by 570% ( about




 7-fold)  between 1976 and the first five months of 1977




liable 14,  0.13 to 0.87 per 100 live births)  I _i n Reggiani




 1977) .   The  birth  rate  dropped "sharply" following the




 explosion  and  cows aborted and produced malformed offspring




 following the explosion.  ! Whiteside) .  A local doctor




 noted  a  "marked increase" in convulsions among infants.




I convulsions could be  delayed effects of neurotoxicity ^n




 ut_ero) .  [Whiteside]) .




       £ b)   Vietnam






       A large  amount  of TCDD- contaminated herbicides




 were  used in Vietnam during 1962-1971.  Possible health




 effects  have been  reported upon retrospectively by groups




 entering Vietnam.  Tung  et al. charged that 2,4,5-T was




 responsible  for much of the Down's Syndrome seen in






                              -46-

-------
[South] Vietnam.  Crummer was quoted by Honoroff as having




observed high  incidences of children with Down's Syndrome.




Tung et al.  also  noted  a very significant increase in the




Hanoi hospitals  in  hepatic  carcinomas in the period  1962-1968




[1790/7911 cancer cases  (10%),  compared to 159/5492  (2.9%)




for the period  1955-1961].




       It  should  be remembered  that most of the accidents




reported here were  retrospective accounts.  In the cases




of Seveso  and Vietnam,  reporting was (and still is)  at




best piecemeal.   The exposed populations contained numbers




of highly mobile  persons who could not be accounted  for




adequately.
     (3)  Exposure  Analysis







       (a)  General  Considerations







       There  are  two components to any pesticide-related




risk: (1) the toxicological  properties of a chemical,




and (2) exposure  to  the  chemical.  The risk assessment is  a




summation of  the  conclusions in each of these areas. A




highly toxic  chemical  may  pose high risk even if  exposure




is low; conversely,  a  compound of  low to moderate toxicity




may pose high risks  if  exposure is high.







       Estimating probable exposure is difficult for a




                       -47-

-------
number of reasons.   While it would be inappropriate  to




attempt a definitive discussion of these problems  here,  it




is useful to.  note  a  few examples.  First, empirical  data on




exposure is less  available than is toxicology data.   Second,




there are a number of exposure pathways which require




consideration  (e.g., inhalation, dermal absorption,




ingestion of  food  residues,  and ingestion of water residues).




Third, the inherent  complexities of the dynamics of  a




chemical's movement  through  the environment create formidable




obstacles to  describing any  given exposure pathway.   For




example, the  chemical may behave differently in various




media depending 'upon a number of environmental factors which




can vary at any one  application site.  Thus, even  when some




empirical data on  a  given route of exposure is available,




there are often uncertainties concerning the applicability




of the data to situations involving conditions which  vary




from those which obtained at the study site.







       The inherent  difficulties of exposure assessment




always create  a troublesome  problem for decision makers.




These problems are of great  concern in situations  involving




chemicals which appear to pose risks even at very  low levels




of exposure.   As discussed above, the TCDD contaminant in




2,4,5-T is clearly such a chemical. For example, TCDD is




carcinogenic  in rats at. doses as low as 1 ppb and  fetotoxic




in mice at doses as  low as 0.01 ug/kg/day.




                          -48-

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       Moreover, the  complexities  of exposure assessment




are also amplified  in situations  involving persistent




chemicals.  This is because  the  length of time a chemical




persists in the environment  can  increase the opportunities




for movement of the chemical and  confound attempts to




eliminate pathways  as pathways of  concern.  Time increases




the possibilities of  variation in  enviromental factors




affecting chemical  mobility.







       The environmental  persistence of 2,4,5-T is relatively




short due to physical,  chemical,  and biological degradation




processes.  On the  other  hand, the contaminant TCDD has a




much longer persistence in soil  and is known to bioaccumulate




in fish (Matsumura  and Benezet,  1973;  Kearney et al.,
             o



1973).







       Generally, exposure assessments involve attempts at




modeling the likely exposure potential through several




pathways which are  identified as  pathways of principal




concern.  The exposure assessment  typically will involve




attempts to describe  the  movement  of the chemical from the




site of application to persons potentially at risk, using




such empirical data as are available on the presence of the




chemical at various intermediate  points in the critical




path.  Conservative assumptions  based upon such things as




knowledge about the behavior of  similar chemicals, typical




environmental conditions  affecting the use site, and




                          -49-

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the like,  are used  to  bridge inevitable gaps in the  empirical



data. The  objective, however,  is a simple one: to obtain  a



qualitative  and  (if possible)  quantitative description  of



the likelihood that a  given chemical will move from  where



it is applied to  a  given group of P.o.t^Mn^tij^lljj. exposed



individuals.





       Since 2,4,5-T first surfaced as a subject of  regula-



tory concern, determining potential exposure has been



the critical issue  on  the risk side of the regulatory



equation.  Uncertainties  about  exposure resulted in suspension



of regulatory action in  1974,  and the launching of an



ambitious  project to generate  exposure data (the "Dioxin
                                               p


Implementation Plan" or  "DIP").   Primarily because of great



difficulties encountered in developing analytical methodologies



with sufficient  sensitivity to measure the extremely low  -



levels of  TCDD which are of biological concern, the  progress



of the DIP has been disappointing.  To date, it has yielded



only fragmentary  information.





       In  my judgment, the information which has recently



come to my attention as  a result of the Alsea study  consti-



tutes a dramatic  and troubling new  point of departure



for analysis of  TCDD exposure  concerns.  As indicated above,



these data show  a striking relationship between 2,4,5-T use



and increased incidences of spontaneous abortions among



                          -50-

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women residing  in  the  use  area.   As  further developed above,

this effect is  an  effect which  one would have predicted as a

likely outcome  of  human exposure,  based upon a body of

animal data of  almost  unprecedented  conclusiveness.  The

Alsea study, to  be  sure, contained no  data showing actual

exposure.   However, concern  for  the health of humans who

may be exposed  to  2,4,5-T  and its  contaminant, TCDD,  is

heightened because  scientists have not demonstrated that

there is a level of  exposure  that  has  no adverse effects in

       */
humans.—   Thus, in  the face  of  the  highly significant

relationship which  the study  showed, and the animal data, I

conclude it is  reasonable  and in  the public interest  to assume
                                                        **/
that the women  in  the  Alsea study were exposed to TCDD.—
^/  A committe of the National  Research  Council of Canada
recently agreed with the  authors  of  the  World Health Organiza-
tion's monograph on TCDD  that  "for TCDD  a no-effect level
for man could not be established"  (NRCC  1978).
^_/  I have found it prudent to suspend  because data from
the Alsea Epidemiological Study indicates that women experi-
encing adverse reproductive effects  may  have  been exposed to
2,4,5-T. Information of this kind  concerning  a chemical's
effects on human populations is rarely  available.  Before
the Alsea Study was completed,  Agency  scientists developed
preliminary exposure analyses  for  2,4,5-T based on use
information, assumptions, and  modeling.   Since I have
information of adverse human effects correlating with the
use of 2,4,5-T, I have chosen  to  rely  on this correlation as
a basis for regulatory action,  rather  than on exposure
analyses based exclusively on  use  information and modeling.
                        -51-

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       Moreover,  I  also conclude that  it  is  prudent to




assume that  individuals who frequent or live in areas where




2,4,5-T is used  may be exposed to TCDD in ways  and under




conditions which  may cause these individuals to be exposed




in ways qualitatively similar to those experienced by the




Study area women.







       As developed below, I find that 2,4,5-T  use patterns




likely to cause  exposure opportunities similar  to the




exposure experienced by the Study area women are the forestry,




rights-of -way , and  pasture uses of 2,4,5-T.   The Agency has




identified pesticide applicators and persons involved in




pesticide application support activities,  and persons living




in or frequenting areas of 2,4,5-T use as the principal




groups of individuals who may be exposed  as  a result of the




forestry, rights-of -way , and pasture uses of 2,4,5-T.







       ( b )
        ( i )  D e s_c_r IJD t i£ n_o f__ Ar e_£







       The Alsea Study Area comprises  approximately




1,600 square miles of  Oregon's forested Coastal  Range centered




around the "Alsea  basin," an area of approximately 400




square miles.   It  is  bounded on the west  by  approximately




70 miles  of the Pacific Coast and extends  inland for distances




ranging from 10 to 35  miles. The Study area  includes all but




                        -52-

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the northern and southern  reaches  of  the Suislaw National




Forest.  Numerous  commercially  owned  and Bureau of Land




Management forested  acreages  are  interspersed throughout




this region. Mountain  elevations  of  approximately 1,000 feet




are not uncommon;  peak  elevation  is  slightly more than 4,000




feet.  The principal rivers  are the  Siletz,  Alsa, Yaquina




and the Suislaw.   Eastern  fringes  of  the area drain eastward




into the Willamette  Valley.   Maximum  runoff  is reached




generally during the winter  months as the result of storms




off the Pacific occurring  usually  as  rain.







       The Study area  is predominantly rural.  The four




largest towns have a total population of 14,450.  All




other towns/villages have  populations of less than 1,700.




Alsea has a population  of  400  (1970  census).  In addition,




many residences are  scattered  througout the  forest areas.




All of the nine women who  were  identified in the first phase




of the investigation resided,  at  the  time of pregnancy, in




rural residences located within 12 miles of  Alsea.







       ( ii )  Us^e^Pattern







       2,4,5-T is  applied  to  the  forests in  the Alsea




area almost exclusively by helicopter for control of undesir-




able vegetation such   as red  alder,  vine maple, salmonberry,




and thimbleberry.  In general,  the  compound is used in the







                        -53-

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spring ^March, April, or May) with  a  second  application




made, if needed, in middle to late  summer ( July  or  August) .




Over the six-year study period,  10,000  pounds  of 2,4,5-T was




distributed over a total area of  approximately 7,000  acres.




The usual practice was to treat  any particular site approximately




once every five years.  However,  contiguous  stands  could be




treated in succeeding years.  The spray program  spans only a




few days' time, with the duration depending  on the  number of




acres to be treated and the  weather conditions.







       To avoid contamination of  water  sources prior  to




1978, the general application policy  was to  avoid spraying




near homes and to provide for a  single  swath of  30  to




60 feet on each side of any  major stream.  In  September




1978, the Oregon Forest Practices Act created  guidelines




which prohibited spraying within  500  feet  of an  inhabited




residence or within 200 feet on  either  side  of streams with




fish and/or ones that are used for  domestic  water supplies.




However, drift and runoff could  contaminate  surface waters.







       f iii)  Population Exposed  to  the	He_rbJL£i.de	







       Population of the Alsea Region is clustered  in




several small towns; there are also isolated homes  and




farmsteads in the forest area.   Groups  which may be traversing




the forests of the Alsea Region  include residents,  workers




engaged in forest management, incidental travelers, hikers,




students, surveyors, and delivery persons.




                                 -54-

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       £ iv)  Modes of Exposure







       The major method of dispensing  2,4,5-T  in  the  Alsea




Forest Region is by helicopters.  Although  the  Oregon Forest




Practices Act prohibits spraying near  homes  or  streams,




there appears a likelihood that residents and  travelers  of




the Alsea Region might be directly exposed  to  2,4,5-T




during periods of application as a result of drift.




Drift from a helicopter flying over  a  forest canopy can




produce drift of the herbicide spray at  significant distances




from the path of the aircraft. Residents or  travelers in the




path of the spray might be doused with the  pesticide  spray.







       Exposure to the population from drift and  direct




contact is by the dermal (exposed skin)  and  inhalation




routes.  Resident populations may also incur exposure to




2,4,5-T and TCDD subsequent to application.  Waterborne




residues are a possible route of exposure;  other  possible




exposure routes include fish, wildlife,  and  other foods




produced or found in the area.  The  fact that  TCDD is




somewhat persistent and bioaccumulative  may  enhance exposure




possibilities.  Furthermore/ pesticide mixers,  loaders,




applicators, and other workers may be  exposed  to  the  pesticide







                              -55-

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      r.(c)   Comparison Between Presumed Exposure  in The
            Alsea Study Area and Possible Exposure in
            Other Use Situations
       The Alsea Study shows a significant correlation

between the use of 2,4,5-T in the Alsea area and  increased

incidence of spontaneous abortions within approximately  two

months after application.  The Agency believes  that  it is

prudent to assume that the women studied were exposed to

2,4,5-T.  While the Agency cannot determine the actual

routes of exposure, information about how 2,4,5-T is applied,

population densities, and proximity of Study area residents

to spray areas provides a basis for making assumptions about

possible chances for exposure.


       That 2,4,5-T was applied by helicopter rather than by

ground application methods in Alsea, enhanced the potential

for exposure to 2,4,5-T from drift.  Aerial application  is a

principal method for applying 2,4,5-T.  A substantial amount of

the 2,4,5-T applied in forests and on rights-of-way  is .

applied aerially.  In contrast, in pastures, application of

2,4,5-T usually is by spot treatment with knapsack spraying

equipment. This method, causing less spray distribution  than

aerial application, lessens potential exposure  from  drift.
                             -56-

-------
       Alsea inhabitants  live  in  towns  and  residences

scattered throughout forests in which 2,4,5-T  was  applied.

Effects occurred even though application  near  residences

and streams was prohibited.  The  Study  area women  who

experienced spontaneous abortions  were  residents of  the

area.  Their exposure to  2,4,5-T  may have occurred either

while they were at home or while  they were  in  nearby forest

areas. Bystanders, workers engaged in forest management,

people visiting the forests for recreational purposes,  and

others would have exposure potential similar to  the  exposure

potential of the Study area women  away  from their  homes.

Because TCDD persists in  the environment, such non-residents

may have been exposed to  2,4,5-T  and TCDD during or  for  some

unknown length of time after application  had occurred.


       The Study area women may have been exposed  to

2,4,5-T or TCDD through ingestion  of drinking  water, fish,

and wildlife.  Residents  are more  likely  to be exposed

through this route than infrequent visitors to the spray

area. Frequent visitors or workers in the area would have

exposure potential similar to  that of residents.   All  other

forest areas in which 2,4,5-T  is  used are most obviously

                          */
similar to the Study area.—
^_/  Commercial forests are  defined  as  those  lands  not
withdrawn for non-timber purposes which  are  capable  of
growing 20 cubic feet of wood  per year of  desirable  species.

                                -57-

-------
       The use  of  2,4,5-T to maintain rights-of-way involves

exposure potential  similar to the exposure potential

of the Study  area  women:  residents of the application area

and workers and  visitors  who frequent the area may be

exposed.


       The Agency  estimates that a considerable number of

people may be exposed  to  2,4,5-T and TCDD as a result of the

use of 2,4,5-T  in  non-urban areas to maintain rights-of-way.

Rights-of-way uses  include highways, railway lines, electric

power lines,  and pipelines.  A principal method of applying

2,4,5-T is by aircraft, which was the method of application

in the Alsea, Oregon area.
       The population  that  is  most likely to be exposed are

people who live in  the path of the spray or in the area of
      * /
drift.—   A large potential exposure group would be

comprised of people  living  along railroad tracks and along
^/  Factors which  affect  drift  include wind direction and
velocity, turbulence,  relative  humidity and air temperature,
atmospheric stability,  pesticide formulation,  application
equipment, and spray volume.  For'purposes of  this analysis,
the Agency conservatively  estimated possible pesticide drift
at 1/2 mile.  The  Agency  notes,  however,  that  pesticides
could drift farther depending on the variables listed above.
Some pesticide drift has  been reported as far  as 22 miles
from target (EPA DRAFT:  "Report  to Congress/Study - ULV," p.
95).  In addition, this  same draft report estimates that
percent of pesticide drift over  1,000 feet from the target
variously ranges from  a  low of  10% to a high of 90%.

                            -58-

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highways.  Other  groups  that  may  be exposed are those that

live in forests or plains  along power lines and pipelines.

The residents may be  exposed  to TCDD through the diet for

longer periods of time due to low levels of TCDD contam-

ination in water  and  food.  An additional potentially

exposed group are people working  in, or traveling through,

the treated area.


       Exposure : from  the use  of 2,4,5-T in pastures is
                                        ** /
likely to be lower than  the Study area.—    Pastures

are likely to be  near farmhouses  and small towns. The

populations which may be exposed  to 2,4,5-T include farm

families, other rural residents,  and workers in rural

occupations. The  predominant  method of application for

controlling brush in  pastures is  spot treatment with knapsack

spraying equipment. The  distribution of 2,4,5-T from this

technique is lower than  that  from forestry and rights-of-way

use, because this technique produces only short-range drift.

Indirect exposure due to residues in food is possible.


       Generally, persons  involved in applying pesticides

have greater exposure to the  chemicals than do residents of
**/  Pasture is defined  as  land producing forage for animal
consumption, harvested  by grazing,  which has annual or more
frequent cultivation^ seeding,  fertilization, irrigation,
pesticide application,  and  other similar practices applied to
it.  Fencerows  enclosing pastures are included as part of
the pasture.

                         -59-

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 the area in which the pesticides are used.  There is no

 reason to believe that this would not be true of 2,4,5-T.

 Therefore,  the Agency is concerned about potential exposure

 to pilots,  ground spray crews, mixers and loaders, and

 flaggers, all of whom are exposed to 2,4,5-T in the applica-

              */
 tion process.~


        For  aerial application, the ground crew, including

 mixers and  loaders of the aircraft, is the group with the

 highest potential for exposure by both dermal and inhalation

 routes, because they handle the concentrated formulations

 ("up to 41%  of 2,4,5-T acid by weight) .  The flaggers on  the

 ground are  exposed mainly by drift of the diluted spray

 deposited on their exposed skin, and to a lesser degree  by

 inhalation.  The pilots are expected to be exposed to

 smaller amounts of 2,4,5-T by dermal and inhalation routes

 because they sit in the enclosed cabin of the helicopter

 while applying the diluted herbicide spray.  For the ground

 application techniques, the applicators and mixers are the

 workers running exposure risk.  Inhalation exposure may  be

 more significant when fine mist sprayers^ for example,
 ^_/ In response to the 2,4,5-T RPAR, the American Paper
 Institute and the National Forest Products Association
 recently submitted a detailed study of aplicator exposure
 to 2,4,5-T during both areial and ground applications
•{2,4,5-T RPAR submission #1023H - 30000/26) .  The results of
 this study indicate that workers who handled the pesticide
 concentrate had the highest exposure, followed by knapsack
 sprayer applicators, mist blower drivers, helicopter pilots,
 supervisors,  and flagmen.

                               -60-

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foliar treatment)  are used  in contrast  to  stump  treatment

spraying with a coarse spray.  The  reason  for  this  is  that

smaller spray droplets are  more readily absorbed through  the

lungs.

     C.  Dete-rminatj.gn of Bene_fj.t_s

       The Agency has evaluated the potential  economic

impacts of suspending the forestry, pasture, and rights-of-way
                                      * /
uses of 2,4,5-T during 1979  and 1980.—   The consideration

of economic impacts stemming from a suspension is limited to

a two-year period because the maximum proj ected  length  of a

cancellation proceeding would be two  years. A  suspension

order remains in effect only during a cancellation  proceeding.

Thus, only the impacts which would  arise during  this period

would be at issue in a suspension.  Any  impacts which would

be caused by a suspension,  but which  would be  felt  after
                                 **/
this period, are also considered.—
^/  The emergency suspension  order will  take  effect  immediately
upon issuance of this Notice  and  remain  in  effect  during
any subsequent emergency suspension  hearings.   At  the
conclusion of the hearings, a decision will be  made  whether
to continue or remove the  suspension  order  during  the
ensuing cancellation proceedings. Ecomonic  impacts are
therefore separately evaluated  for the 3  1/2  month period
allocated for an emergency  suspension proceeding as  well  as
for the two years which may be  required  for a cancellation
proceeding.
^_/ The Agency's analysis  is  based on information  from  a
number of sources including RPAR  rebuttal comments received
by the Agency from registrants, users and other parties
during the RPAR process; and  the  USDA-States-EPA 2,4,5-T
RPAR Assessment Report ^'-February  15,  1979)  as well as other
relevant data.  Although the  2,4,5-T  Report attributes  a
role to EPA, the final report has neither been  completely
reviewed nor approved by EPA.   Therefore, although the
Agency has relied on some  portions of the report,  it cannot
and does not wish to adopt  all  portions  of  the  report as
reflecting the Agency position  on matters discussed  therein.

                            -61-

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        2,4,5-T  is  registered  for  control of woody and




herbaceous plants  on  rights-of-way,  forestry,  range,  pasture,




and  rice.  The  suspended  uses ( rights-of-way,  forestry,  and




pasture)  comprise  about 74% of  the estimated 9.3 million




pounds  of 2,4,5-T  active  ingredient  used annually in  the




U.S.  Rights-of-way usage (3.8  million pounds)  is the single




largest use,  comprising an  estimated 41% of total annual




usage;  forestry^2.6  million  pounds)  and pasture usage




{" 500,000  pounds) account  for  about 28 and 5%,  respectively,




of annual 2,4,5-T  usage.







        Economic  impacts of  suspending forestry,  pasture,




and  rights-of-way  usage of  2,4,5-T during 1979 and 1980




were evaluated  assuming all registered alternatives are




available, except  silvex  which  is  also subject to suspension.




The  analysis  often provides qualitative estimates of




impacts due to  a lack of  data to  support precise quantitative




estimates.







        Economic  impacts during  1979  and 1980 would de-




pend upon the treatment options actually selected by  users.




For  many, use of alternatives to  2,4,5-T during  1979




and  1980 would  be  optional ( i.e.,  could be delayed to a




later year) .  Other users might choose to use  alternatives




immediately.  It is not possible  to  predict with precision




which option  may be selected  by the  many potential users of




                              -62-

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2,4,5-T during the suspension period.




       The Agency's analysis indicates  that  the  suspension




of 2,4,5-T ( and silvex)  for forestry,  rights-of-way,  and




pasture uses during 1979/80 would  not  signficantly affect




U.S. production or prices of major commodities  and services




from these sectors.   Impacts on  productivity and costs




during the two years  would generally be regional in nature




but insignificant on  the national  level.   Industry impacts




would be nominal within  the context of  year-to-year variations




in economic activity  due to interaction of normal supply and




demand forces, as affected by weather,  general  monetary and




fiscal policies, international economic developments,




etc .







       Economic impacts  during the 3  1/2  month  emergency




suspension proceeding would negligible.  The only noteworthy




impact would involve  the forestry  use  in  which  spring




applications predominate in the  Northwest.  Even then, the




impacts are nominal during the 3  1/2 month suspension




proceeding.
                             -63-

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       The minimal nature  of  the  overall economic impacts




follows from:  ( a)  the  inherent  flexibility of treatment




schedules, permitting delays  in  treatment to ameliorate




negative economic impacts  of  suspension; ( b)  the existence




of chemical/ mechanical, or manual  alternatives I or combina-




tions)  which are currently being  used  on these sites,




even though they are not generally  as  cost-effective as




2,4,5-T; andr( c)  the 2,4,5-T  usage  which normally would have




occurred on the suspended  sites  represents a small fraction




of the overall industry acreage ( e.g.,  0.2 percent of




forestry acreage in the U.S.)  ;  concentrated acreages needing




treatment with alternatives during  the  suspension period




would occur only at the regional  and local level.









       Each of the suspended  uses is examined in detail




in the following discussion.







     f 1)
       There are about  500,000,000  acres of commercial
                              -64-

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       * /
       -  in the U.S. of which  1.16  million acres (0.23%)  are
forests
treated annually with 2,4,5-T.  This  herbicide can be used
                                                  * * /
at either or both of two stages in the  production—  of

conifers (softwoods):   (1) preparing sites  for reforestation

and (2) releasing young trees  from hardwood competition.

Each operation is undertaken once  in the 50 year cycle of a

softwood stand.  2,4,5-T as well as  other chemical and

non-chemical control methods may be  used individually or in

combination for site preparation and release.


       Use of 2,4,5-T for  site preparation is not critical

although it is cost  effective.   Several other chemical as well-

as non-chemical methods  are  also effective for site preparation.

Picloram and 2,4-D,  sometimes  combined, are the most effective

substitute chemicals.   2,4-D costs  less than 2,4,5-T but controls

a more limited spectrum  of weeds.


       Because the  release (weeding) operation is conducted

after the seedling  trees  are in place,  a selective herbicide

which will not harm  the  seedlings is preferred*,  This  is

particularly true  for pine;  only 2,4,5-T provides control of
^/ Commercial  forests  are defined as those lands not withdrawn
for non-timber purposes  which are capable of growing 20
cubic feet of  wood  per year of desirable species*
^_/ 2,4,5-T  is sometimes used for other forestry herbicide
operations,  including  rehabilitation or species conversion,
fuel break maintenance,  and timber stand improvement.  The
major forestry uses of 2,4,5-T are site preparation and
release, which are  the focus of this analysis.

                            -65-

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the wide  variety of competing hardwoods  without damaging the




sensitive seedling pine.  This often  critical operation is




most  effective  when performed two to  ten years after estab-




lishment  of  the stand.  If competing  hardwoods are not




suppressed,  the seedlings may be overtopped,  and stand




growth  and density may be decreased.   The benefits of weed




control for  release and site preparation of  conifer crops




are increased yields at harvest time.  For  stands receiving




no weed control for site preparation  or  release,  annual




growth  can be substantially reduced on the  most productive




sites.







        Approximately 2 million acres  of  forests currently




receive site preparation while approximately  1.5  million




acres receive release treatments.  2,4,5-T  is used for




about 20% of the site preparation (1.16  million pounds on




414,370 acres)  and about 51% of release  treatments (1.48




million pounds  on 749,320 acres).  Other  chemicals are often




used for  both practices, as well as hand, mechanical, and




prescribed burning treatment.







        Herbicides are applied by broadcast  foliage spray




(aerial and  ground)  and by individual  stem  applications.




Because it is selective and does not  injure  conifers,




2,4,5-T is the  only herbicide widely  applied  by broadcast




methods.  Broadcast foliar applications  account for 89%, and




                         -66-

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the remainding  11%  are  individual stem treatments.  Other




registered chemicals  are  applied almost entirely by stem




treatments since  they  are damaging to conifers.







       Site preparation with other chemicals generally costs




$20-50/acre, which  is  somewhat more than with 2,4,5-T




treatment.  Mechanical  methods may range from $45-$200/acre.




Prescribed burning  is  effective at $3-$14/acre in the East.




In the Pacific  Northwest,  burning costs $85-$225/acre, is




very risky and  hard to  control, and may be restricted




because of smoke  management regulations. Severe sprouting




after fires requires  1-2  release treatments in nearly all




 cases.  Mechanical or  combination methods provide the best




sites for reforestation.   They are limited, however, to




gentle terrain  and  may  cause erosion on sloping lands.  They




can sometimes be  incorporated with logging slash cleanup on




western forests,  reducing the costs of new stand establishment,




       Release  of young conifer stands from hardwood




competition can be  accomplished only by chemical or hand




methods.  Chemicals,  principally 2,4,5-T, provide some




control of sprouting  which manual methods do not.  Thus,




manual weeding  may  require two or more treatments in severe




cases.  Only two  other  chemicals, fosamine and glyphosate




(registered only  in Washington and Oregon), provide this




                        -67-

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selective control.   Their costs are $30-$250/acre.  Aerial




applications of  2,4,5-T  cost $10-$20/acre in the South  and




$10-$75 in the West.   Hand methods may be used to a limited




extent where labor  is  available,  at costs of $ 30-$200/acre




or more depending on  density and  size of hardwoods.  No




chemical other than 2,4,5-T is presently available in the




eastern U.S. where  67% of the acreage of the 2,4,5-T for




release work is  accomplished.






       Intensive management of young confier stands is




practiced primarily by public agency managers or timber




companies, rarely by  small owners.  Site preparation is




normally tied to harvest cutting  which in turn is dependent




upon marketing commitments (e.g., U.S. Forest Service)  or




company raw material  needs (industry).






       Where current  site preparation plans include 2,4,5-T,




some alternative method  will likely be used.  Costs may




increase from 20-200%  for most alternatives now available.




If budgets are inflexible, harvest cutting may be reduced




(USFS or state agencies)  in order not to accumulate acres



                          */
needing site preparation.—   Industry owners are more




likely to continue  planned harvests and absorb the increased




site preparation costs.
^/  The U.S Forest  Service  is required to reforest havested

acres within three  years  under the National Forest Manage-


ment Act of 1976.




                          -68-

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       Release  activities  are  less dependent on other




activities and  can  ordinarily  be postponed for a few




years, at the increasing  sacrifice of some future production.




If budgets are  relatively  fixed, some of the more productive




acres will be treated  in  1979-80 where alternatives are not




too costly. Because  of  the lack of a selective herbicide




other than 2,4,5-T  for  use on  pine stands (especially in the




South and North), it is anticipated that approximately




60-70% of these  stands  in  need of release will go without




treatment during  1979-80.  In the West, about 3/4 of needed




release will be  scheduled  using other herbicides, although




full adjustments  may be delayed to the second year.









       Immediate  impacts  on users would occur in two forms:




increased costs  and  reduced future productivity.  Cost




increases for site  preparation would range from $20-$200/acre




depending on the  method chosen.  For the first year, release




costs would go  up in the  West  by $ 10-$200/acre on those acres




where young stands  are  threatened with imminent loss to




weeds, possibly  20%  of  the 246,000 acres currently released




with 2,4,5-T.   The  second  year could see the use of substi-




tutes on the entire  1/4 million acres, as budgets are




adjusted to new  costs.   Current total release costs in the




South would drop  as  many  acres (65%) are left without




treatment.  However, there would be increased release costs




                           -69-

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as release is  attempted  at  a later time, as well as produc-




tivity losses  in  the  future.







       Reduced  future productivity may be reflected in




harvest cut  adjustments  where budgets cannot accomodate




the increased  costs of alternate methods.  The U.S. Forest




Service is presently  considering proposals for about 34,000




acres of 2,4,5-T  applications on National Forests for 1979




(USFS 1979a).  Because of recent policies on the use of




2,4,5-T, these  proposals are to cover situations where no




alternative  weed  control appears feasible.  The loss of




2,4,5-T for  these situations could conceivably cause a




reduction of FY 79/80 timber sale offerings to avoid accumu-




lations of future problem areas.  However, it is not likely




to do so, as discussed below.







       Since weed control occurs early in the life of forest




stands, the  economic  consequences of reduced control are




delayed until  harvest time  30-125 years in the future.




However, substained yield management (as required on National




Forests by the  Multiple  Use-Sustained Yield Act of 1960)




requires a matching of harvest to anticipated growth of the




£nj:i_££ f.EE6.^*  Any loss in productivity due to decreased




weed control would, on National Forests, be reflected in




reduced harvests.  Obviously this effect would accumulate for




each succeeding year  of  reduced weed control.  These adjust-




                         -70-

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merits are normally made  at  10-year intervals for most

National Forests, and  may not  be  reflected in immediate

harvest reductions during a one  or two year suspension.


       Private industry  would  likely accept the losses

in ultimate harvest  as they occur in the future, with no

immediate reduction  in harvest schedules (API/NFPA rebuttal

to the RPAR on 2,4,5-T,  1978).
                                           /
       Suspension would  increase  annual control costs by

$13.5 million if all  1.16 million acres now treated with

2,4,5-T were treated with alternatives (USDA/States/EPA,

Feb. 15, 1979).  This  is an increase of $11.64 per treatment

acre.  For site preparation, the  increase in cost would

average less than this,  e.g.,  $5-$10 per acre; for release,

it would be generally  much  higher due to increased use of

the more costly manual methods,  e.g., $30-$200 per acre in

many cases.  No overall  average  cost impact can be computed

on a percentage basis  with  current information. It is

unlikely that alternative control plans would be in full

effect until the second  year of  suspension.   The first

year effects would likely be 50  to 70% of these costs($7-$10

million), with added spending  in  later years to make up for

operations postponed the first year.


       These added control  costs  due to suspension would be

                          -71-

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in addition  to  the value  of  any actual  growth losses associa-




ted with delayed  or  less  effective site preparation and/or




release treatments.  A minor  yield  loss  is projected for




loss the first  year  of  suspension  ( less than 0.2 percent of




U.S. softwood production) . This would increase in the second




year to about 0.5 percent.   These  losses in yield,  if realized would




have an estimated reduction  on  forestry income of $9.6 million




the first year  of suspension and about  three times  this amount




the second year ($29 million) under the assumptions of the USDA/




State/EPA 2,4,5-T Assessment Team  Report [USDA/States/EPA,




Feb. 15, 1979].







       The total  impact,  including both increased control




cost ( $7 to  $10 million)  and yield losses,  if realized (up




to $9.6 million)  would  be in the range  of $10 to $17 million.




( If all 2,4,5-T acres were treated with alternatives, which




is unlikely, the  total  impact would be  about $21.3  million




the first year.)  For the second year,  the  combined impact




would be more,  totalling  $36 to $39 million ($7-$10 million




plus $29 million  in  eventual yield losses) .  While  significant,




these impacts are rather  nominal within the context of overall




forestry industry of the  U.S.







       Effects  on wood  product  prices would only occur




if a decision were made by the  U.S. Forest  Service  to




curtail timber  sales in the  near future.  The limited







                          -72-

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impacts of suspension  on  production would not necessitate a




significant increase in wood  product prices.






       The economic impacts of  suspension of the forestry




use for 3 1/2 months during emergency proceedings would be




nominal even though conifer release treatments in the




Pacific Northwest, are generally  applied in the spring,




before bud break which occurs by  March.   Some such treatments




may have already been  made  and  delay of  others for two to




four months during a suspension proceeding is of little




significance.
     ( 2 )  Rights.- of_- W ay_







       2,4,5-T is  used to  control woody and herbaceous




plants on rights-of -way  (railroad,  highway, electric transmis-




sion, and pipeline) which  could interfere with the functioning




of the system (e.g., weed  encroachment on highways), threaten




the system's equipment,  and/or  interfere with inspection and




maintenance of the system.   2,4,5-T is considered to provide




longer control of  pest plants  than other control methods




without harming  grass  and  other vegetation desirable for




erosion control, wildlife  shelter,  and aesthetics.







       Chemical, manual, and mechanical methods of control




are used in various combinations on rights-of -way acres,




depending on the terrain,  availability of labor, type of




                       -73-

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equipment  and  species  type and density.  Combining control




methods is  a common  practice on rights-of-way acreage.







       A relatively  large number of acres apparently




receive no  vegetation  management.  Only about one-fourth  of




electric utilities,  railroads, pipelines, and highway




departments have  all acres in management programs.







       For  highways  and pipelines,  mechanical methods  are




used on more acres  than any other method.  Manual is used on




most acres  of  electric acreage and is frequently employed as




follow-up  treatment  to supplement chemical control.  Somewhat




less than  1/3  of  all rights'-of-way acreage are estimated  to




be treated  by  manual methods.  Chemicals other than 2,4,5-T




are more common on  railroad acreage.   Acres treated with




chemicals  are  most  likely to be acres where mechanical




control is  difficult and where other  alternatives are




expensive  or relatively ineffective.







       About 683,000 rights-of-way acres are treated with




2,4,5-T on  the average of once every  four years, or 2.7




million acres  total.  An estimated 3.8 million pounds a.e.




are used annually.   Only a small percentage of rights-of-way




vegetated  acres are  treated:  6.6% of railroad (127,000




acres), 9.4% of electric (465,000 acres), 4% of pipeline




(22,000 acres), and  0.8% of highway (68,000 acres).  Usage




is believed to be mainly in the eastern and far northwestern




parts of the continental U.S.




                             -74-

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       Other  chemicals  are also currently used on many




rights-of-way  acres/  including dicamba, 2,4-D, dichlorprop,




and picloram.   Almost 13% of the highway, 25% of electric




utilities, 45%  of  railroad,  and 5% of pipeline acreage  is




treated annually with other  chemicals (which may include




some non-herbicides).







       2,4,5-T  is  $1.00 to $3.00 more expensive per  application




than other chemicals, for aerial, selective basal,  and  stump




spray, which  account  for about 65% of annual acreage  treated.




For ground broadcast  or selective foliar treatment,  2,4,5-T




is cheaper ($2.00  to  $19.00  in one case). The major  economic




advantage of  2,4,5-T  is in the longer period of control it




is said to provide.   Generally, mechanical and manual




methods are much more expensive than chemical methods.







       With use of  2,4,5-T suspended, rights-of-way  managers




would be faced  with  two main choices:  (1) use alternative




chemicals on  acres  scheduled for treatment or (2) postpone




any treatment,to see  if 2,4,5-T would be available  the  next




year.  They would  most  likely use alternatives on at  least




some acres, in  the  Southeast and Pacific Northwest,  where




plant growth  is rapid.   The  percentage of acres treated with




alternatives  would  vary by right-of-way type and would




probably be lower  for railroads and highways, since  they




appear to be  more  flexible in treatment schedules.




                          -75-

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       If some  acres  are  not  treated during the first

year following  suspension,  they would probably be added to

scheduled treatments  in the second or third year.  It can be

assumed that many managers  would continue treating acres

each year as scheduled with alternative herbicides because

of increases in  size  and  density of pest plants.  If so,

annual costs for vegetation management for highways and

railroads would  increase  by about $133,000 and $1,845,000,

respectively, if they treat all acres with alternative

herbicides.


       Costs for electric and pipeline rights-of-way

would temporarily decrease  by an estimated $680,000 and

$28,000, respectively, each year during suspension, mainly

because of the  high proportion of aerial and selective basal

applications.   These  applications are lower in cost than

2,4,5-T but must be repeated  more often.  There would

be a net cost increase over time due to suspension only if

2,4,5-T is not  available  after the suspension period, i.e.,

if it is cancelled.


       The overall net cost increase for all rights-of-way

types due to suspension only  would be about $1.3 million per

year during the  1979-1980 period.  These changes in vegetation

management costs are  not  expected to impact industry net

revenue or operating  costs  significantly.  Increased vegeta-

tion management  costs due to  suspension would be less than

0.1 percent of  operating  expenditures for highways and

railroads.
                        -76-

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       Impacts at the  consumer  level  due to suspension

of highway and railroad  uses  are  estimated at less than

$0.03 per household per  year. This  is based upon the annual

cost impacts noted above ($2.0  million)  and the number of

households in affected regions.   No significant macro-economic

impacts would be expected  from  suspension of 2,4,5-T on

rights-of-way.


       In view of the  limited economic impacts from a

two-year suspension period,  economic  impacts during the 3

1/2 months required for  a  suspension  proceeding would be of

no economic significance on  rights-of-way.


     (3)  £££ture


       2,4,5-T is used to  control a wide variety of wood

                                 */
and herbaceous weeds in  pastures—  throughout the U.S.

Weed control in pastures is  economically sound where the

cost of control is exceeded  by  the  value of increased

forage yield due to suppression of  competitive non-forage

vegetation.  It is also  practiced for reasons of long-term

pasture maintenance and  cheaper fence maintenance.  Weed
*/ Pasture is defined  as  land  producing forage for animal
consumption, harvested by grazing,  which has annual or more
frequent cultivation,  seeding,  fertilization,  irrigation,
pesticide application  and other similar practices applied to
it.  Fencerows  enclosing  pastures  are included as part of
the pasture.

                          -77-

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control  by means  of  2,4,5-T is now practiced  annually on

about  1% of  U.S.  pasture acreage (1.0 million of  the estimated

101 million  acres of pastureland in the U.S  (48  states)).

This use includes approximately 500,000 pounds of active

ingredient of  2,4,5-T annually.  Generally,  2,4,5-T is

applied  in pastures  as a spot treatment with  backpack or

hand-held sprayers,  although some broadcast  treatments are
                                 **/
also used.   In contrast to range—, little  2,4,5-T is

aerially applied  to  pastures because landowners  rarely allow

weed infestations to become sufficiently dense to justify

aerial application.


       There appear  to be effective chemical, manual, and/or

mechanical control alternatives for all species  in all

regions, although no single set of alternatives  can be used

on all weed  species  or in all parts of the country.   Thus,

alternatives such as picloram, dicamba, undiluted 2,4-D, and

hand labor can generally provide the same level  of control

as 2,4,5-T,  although at higher rates of application and/or

higher expense.   Since equally effective alternatives are

available, no  yield  impacts are expected during  the 2-year
^/ Range is  non-pasture grazing land on which
forage is produced  through native species, or on  which
introduced species  are  managed as native species.   This
precludes land  on which regular cultural practices  of  the
nature contained in the pasture definition.

                           -78-

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suspension period. On  those  acres  where the conditions and



type of weed permit use  of  an  alternative which is not more




expensive than 2,4,5-T,  it  is  likely  that these alternatives




will be fully employed.   Here  no  negative economic impact




would be experienced.







       On those acres  where  the use of  alternatives will




cost more than scheduled 2,4,5-T  treatments,  treatment




may be delayed, dispensed with entirely,  or the more expensive




alternative employed.  Since treatments with  2,4,5-T are




generally effective for  5 to 10 years,  the timing  of control




is largely voluntary.  Therefore,  delay  during the  suspension




period may be practical  on much of the  acreage scheduled for




treatment.  Treatment  may be entirely dispensed with on




acres scheduled for 2,4,5-T  treatment which only marginally




require such treatments.







       Presently the chemical  costs of  2,4,5-T treatments




are about $2.00 per acre (or about $2.0 million on 1.0




million acres).  The chemical  cost of alternatives is




estimated at about $6.00 per acre.  Thus,  for each acre




treated with alternatives during  suspension,  the cost impact




would be $4.00.  If all  1.0  million acres were treated, the




cost impact would be $4.0 million.  Since treatment is a




given year is quite optional during the 5 to  10 year treatment




cycle on pasture, as many as one-half to  one-fourth might




defer treatment in 1979/1980.   This would reduce the impact




to $2.0 to $3.0 million  per  year  during suspension.




                          -79-

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       The economic  impacts  of  a two-year suspension of  the




pasture use of 2,4,5-1  would be of no consequence on a




national basis. It would  be  of  significance to the individual




owners or operators  whose pastures are due for immediate




treatment and on which  more  expensive alternatives must  be




used.  These impacts would be of limited local/regional




concern.







       In view of the limited economic impacts of a two-year




suspension, the economic  impacts during the 3 1/2 months




required for a suspension proceeding would be of no economic




significance .
               M ATT E R S
       This order  directs  the emergency suspension of the




forestry, r ights-of -way ,  and pasture uses of 2,4,5-T.




Registrants affected  by  emergency suspension actions may




request an expedited  hearing before the Agency.  This




section explains how  to  request an expedited hearing,




the consequences of requesting or not requesting an expedited




hearing, and the procedures  which govern an expedited




hearing in the event  one  is  requested.
                           -80-

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     A .
       ( 1 )  Who May  Request a Hearing and When the  Reguest




            Should Be  Made







       Registrants of  2,4,5-T products registered for  the




forestry, pasture, or  rights-of -way uses of 2,4,5-T may




request a hearing on these specific registered uses of




2,4,5-T within five  days  after receipt of this opinion  and




order .







       ( 2 )  How to Request a Hearing







       Registrants who request a hearing must follow




the Agency's Rules of  Practice Governing Hearings (40  CFR,




Part 164).  These procedures specify, among other things:




(1) that all requests  for a heari.ng mu'st be accompanied  by




objections that are  specif i
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     B.  Consequences of Filing a Hearing Request







       Under FIFRA Section 6( c) I 3) the emergency suspension




order becomes effective immediately and, unless stayed,




continues in effect until completion of the  expedited




hearing and issuance of a final order of suspension.   The




statute provides that where an administrative hearing  is




requested, the emergency order is subject to District  Court




review on the emergency finding.  The final  suspension order




issued by the Administrator after a hearing  may keep the




suspension in effect, modify it, or terminate it.   A final




suspension order issued following a hearing  is then reviewable




in the Court of Appeals.







       The statute provides that if a hearing is requested




on the Administrator's emergency suspension  actions regarding




2,4,5-T before the end of the  five-day notice period,  the




hearing stage is to begin within five days after receipt




of the request, unless the registrant and the Agency agree




that it shall begin at a later time. No party, other than




the registrant and the Agency, is to participate, except




that any person adversely affected may file  briefs  within




the time allowed by the Agency's rule.  Hearings on emergency




suspension, like hearings on ordinary suspension, are




subject to the provisions of subchapters II  of Title




5 of the United States Code, except that the presiding







                             -82-

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officer need  not  be  a certified hearing examiner.  The




presiding officer  has ten days from the conclusion of the




presentation  of  evidence  to submit recommendations to the




Administrator, who in turn has seven days to issue a




final order on the issue  of suspension.







     C .
       Under the  statutory scheme,  if there is no request




for a hearing on  the  Administrator's suspension actions




within the five-day notice period,  the emergency suspension




order becomes a final suspension order, which remains  in




effect until the  conclusion of the cancellation proceedings,




unless modified or vacated sooner (40CFR 164.130).  Court




review of an emergency suspension order, including the




special review before the District Court discussed in  Part




II is available only  if  an administrative hearing has  been




requested within  the  applicable five-day period [FIFRA




Section 6(c)(2),  6(c)(3)].
       EPA's rules  of  procedures for expedited hearings  are




set forth at 40  CFR Part  164,  Subpart C.  I do not know  if  a




hearing will be  requested on these suspensions.  If it is,




however, I am establishing the following procedures to




supplement the existing  regulations in governing its




conduct .




                           -83-

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       1.  A deadline  is  being  established for the comple-




tion of all hearing procedures  and the rendering of a




recommended decision under  40 CFR 164.121(j).   That dead-




line is 90 calendar days  from the first prehearing con-




ference, which shall be held in accordance with the time




requirements described below.







       2.  I am naming certain  EPA employees to serve as a




hearing panel in any hearing arising out of this notice (see




Appendix A).







       I am naming certain  additional persons  to be available




to provide technical advice and staff support  to the hearing




panel (see also Appendix  A).  If questions arise at the




hearing which persons  in  this category are uniquely qualified




to assess, they may be called on to serve on the panel




either in addition to, or in substitution for, the three




panel members named above.







       The panel will  conduct the hearing and  submit a




recommended decision to me  under 40 CFR Section 164.121(j).




None of the persons named above is subject in  the normal




course of their duties to the supervision or direction




of any employee or agent  of EPA who is a member of the




Agency trial staff named  below.   See 5 U.S.C.  Section




554(d)(2).




                          -84-

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       Since 5 U.S.C. Section 554( d) I  1) provides  that

those presiding at adj udicatory hearings may not  "con-

sult a person or party on a fact  in issue  [in  the  course

of preparing their decision] unless on notice  and  opportunity

for all parties to participate,"  neither myself nor my

appellate staff will consult with the panel or its supporting

staff on any matters involving this case from  the  date  of

notice until a recommended decision is issued.  Members of

my appellate staff are also listed  in Appendix A.  We will

conduct an independent review of  the  questions presented on

appeal of any recommended decision.   However,  in  doing  this

we will feel free to consult with the hearing  panel and the

support panel, since they will have conducted  the  initial

proceedings and brought expert knowledge to evaluating  the

record.


       The following Agency bureaus or divisions,  and

their staffs, are designated to perform all investigative

and prosecutorial functions in this case:  Office  of

                        */
the Deputy Administrator— , Office  of Toxic Substances,

the Office of General Counsel, and  the Office  of  Enforcement.
jJV  The Deputy Administrator may properly be  included  in
the trial staff since the prohibitions of 5 U.S.C.  Section
SS-tfd)  do not apply to  "the agency".  Her inclusion  is
necessary if guidance on general policy matters  is  to  be
available to the trial  staff and, to  free a high agency
official to talk to outside interested persons about the
questions involved without the constrains otherwise  imposed
by the ^x P_ar^e provisions of the APA and the Government
in the Sunshine Act.  The Deputy Administrator will  take
no part in the detailed work of preparing and presenting
the Agency's case.

                            -85-

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       From the date of  this  notice  until  any final decision,

no member of the hearing panel,  its  support staff,  my

appellate staff, or myself, shall  have  any 
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           b.  The  scheduling  of  any hearing, particularly
in its earlier stages,  involves  a balancing between the

need to conduct  an  expeditious hearing and a concern

that the hearing  not  proceed too  far before the identity

of those registrants  requesting  a hearing is established.

In arranging for  the  first  prehearing conference,  I have

attempted to accommodate  both1  interests.   The hearing

panel shall convene the first  prehearing  conference within

five days after  receipt of  the last request for a hearing

by a registrant  or  15  days  after  the issuance of my

opinion and order,  whichever comes earlier.  The 15 day

maximum should ensure  that  all registrants wishing to

participate in the  hearing  have  been given ample time

to file a hearing request after  receiving notification

of my suspension  actions.


           c.  Within  ten days from the first prehearing

conference, any  person  requesting a hearing shall submit

focused written  comments  on this  opinion  and order con-

sisting of a counterstatement  of  proposed findings on

the issue of imminent  hazard presented by 2,4,5-T together

with supporting  information.   A  narrative summary explaining

its bearing on the  case should also be included.


           d.  The  Agency trial  staff shall have seven

days thereafter  to  file supplemental information and

comments.

                             -87-

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           e.  Within five calender days from  the




filing of any supplemental information by the  Agency




staff, the panel shall convene a second prehearing




conference.  At this conference all parties  shall




appear prepared to present arguments on the  signfici-




ance and relevance of the material already presented.




This prehearing conference shall also hear all  requests




for oral presentation of direct evidence and cross-




examination, and the reasons supporting them.   At this




time each party shall present the names of witnesses




available for cross-examination on the matters  the




party is putting into issue.  The party may  list




documents (or portions thereof)  on which the potential




witness is available for cross-examination in  lieu




of filing a formal witness statement.







           f.  Within five days after the prehearing




conference is over, the panel shall issue a  hearing order




setting the schedule for oral presentation of  witnesses  and




cross-examination.







           ( 1)   Requests for oral presentation  of direct




testimony shall be granted only if it is demonstrated that




the testimony can be presented meaningfully  only in that




form; in all other cases, direct testimony shall be in




writing.







                            -88-

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            (2)   Requests  for cross-examination shall be




granted only  if  all  of  the following showings are made:







         i.   The request  concerns factual matters.  Cross-




examination will not be granted on matters of policy




or law.







         ii.  The factual matters are legitimately in




dispute in  light of  the record.







         iii.  The factual matters are material to the




decision to be made.







         iv.  Cross-examination is the most efficient




way•of resolving the dispute over these factual matters  (as




opposed to  such  alternatives as production of further




information,  or  informal  conferences).







         v. There is a  reasonable expectation that cross-




examination will resolve  the issue of material fact in a way




likely to influence  the final decision.







            g.  The testimonial phase of the hearing shall




begin three days after  issuance of the order setting the




hearing schedule.  At the hearing, the panel shall take  an




active role in the development of the record through




questioning of witnesses  and by issuing procedural orders




where necessary.




                           -89-

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           h.  At the end  of  the  initial  testimonial




phase, the hearing panel may  permit  the  introduction of




additional information  designed  to  rebut  the contentions




made by opposing parties.







           i.  The panel may  revise  any  of the procedural




provisions of this notice  other  than the  overall 90-day




deadline for rendering      a  recommended  decision the time for




which starts running after  the first pre-hearing conference.







       A discussion of  some aspects  of these procedures




follows:







       ( 1)   Deadlines







       Deadlines for completing  proceedings under FIFRA




have been twice endorsed by the  National  Academy of Sciences




[National Academy of Scienc.es, Decision  Making in the




Environmental Protection Agency,  Vol.  II,  p. 84 ( 1977) ;




National Academy of Sciences, Decision Making for Regulating




Chemicals in the Environment, p.  30  I 1975) ] .







       In addition, Congress  has  demonstrated a concern




for speedy action where suspensions  based on a potential




threat to human health  are  concerned.  It has required a




hearing on such a suspension  to  begin  five days after it is







                              -90-

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         */
requested—  , and  has  allowed ten and seven days respectively

for preparation of  the  initial and final decisions once the

hearing is over  [FIFRA  Section Si c) I 2) ] .  FIFRA was amended

in 1975 to require  consultation by EPA with the Department

of Agriculture and  a  scientific advisory panel before taking

action in many cases; suspensions based on human health

grounds/ however, were  exempted from those requirements to

allow speedy action where  speedy action was desirable

[121 Cong. Rec. H 9895-96  ( daily ed. Oct. 9, 1975) ; 121

Cong. Rec. Section  19820-21 1 daily ed. Nov. 12, 1975) ].


       Deadlines  for  completing the hearing have been

imposed in prior  suspensions.   See, e.g., ^n_£^j	Vesicol

C hemJU: aj._C p_li_e t_a 3.. , 41  F.R.7552, 7553 (Feb. 19, 1976)

[Notice of Intent to  Suspend Heptachlor and Chlordane], and

~L_n_r^ej_	P_i_b£omo^h^.oro|>3:op_an£,  42 FR 48915 (Sept. 26, 1977).

[Notice of intent to  suspend and conditionally suspend

registrations of  pesticide products].   The requirements set

forth in this order simply carry forward that practice.
^_/  I do not regard  the  procedures set forth below as
inconsistent with  this directive.   What concerned Congress
was plainly that the hearing ^tajje of Agency decision-
making begin promptly, not  that the oral hearing itself
start unconditionally in less than a week.  To interpret
the law otherwise  would  forbid the use of such accepted
aids to efficient  decisions as prehearing conferences in
precisely the cases  where  efficiency is most required.

                              -91-

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        ( 2 )   Use of a Panel







        Despite the need for speedy  action,  the issues




involved  in  suspension are complex.  Under the statute,  a




judgement  of  "imminent hazard" must  be based on considera-




tion of  costs  and risks of all types [FIFRA Sections 2(1),




2(bb)].  Given  the necessary time  constraints and the prelimi-




nary nature  of suspension as a remedy,  factual certainty may




be elusive.   "[T]he function of the  suspension decision




is to make a  preliminary assessment  of  evidence, and probabi-




lities,  not  any ultimate resolution  of  difficult issues"





I HBZiE°JlE S. S. t ji_l _ D e f_ ^B f. f.—ZEB.SL s __ iB.£ • v •  EPA» 510 F.2d. 1292,




1298 (D.C. Cir.  1975), quoting from  Envi.r_onme_nt al__De_f_e_ns_e__




           v •  EE.& ' 465 F . 2 d . 528, 537 (D.C. Cir. 1972)].
       Arriving  at even such a preliminary assessment




can present  formidable difficulties.   Considering risks,




questions  can  arise concerning the  dispersion and persistence




of the pesticide in the environment  and certain parts of  it,




the conduct  of  animal feeding studies,  the meaning of




those studies  for human health, the  validity of relevant




epidemiological  studies, the reliability of using known




human exposure  from one use pattern  as  a predictor of




potential  human  exposure in other use  patterns, and finally




on what the  upper and lower boundaries  of any risks may be




and how firmly  they are established.   Considering benefits,




                            -92-

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questions can  be  raised about the extent of use, the  availa-

bility, practicality,  and effectiveness of substitutes  both

now and in the  future,  and the range of the probable  economic

impacts of a temporary  ban on the pesticide, or some

use of it, in  the light of all these factors.


       The job  will  be  easier and better performed, if  I

am allowed to  rely directly on the talents of EPA  employees

with expert knowledge  of the technical fields involved  and

with the professional  ability to assess problems arising  in

them.  I believe  it  is  for this reason that Congress  has

provided that  those  presiding over suspension hearings  need

                         */
not be hearing  examiners— .


       (3)  Conduct  of  the Hearing


       Overuse  of cross-examination and courtroom  formali-

ties, I believe,  has made many FIFRA proceedings far  longer

than was consistent  with any rational purpose.  The overwhelm-

ing bulk of legal analyses by those who have studied  the

problem, and EPA's own  experience demonstrate that scientific

and economic issues  can be clarified by the exchange  of

written material  far more efficiently than through courtroom

hearings. I am  directing that written submissions  be  used
^_/  The fact  that  more  than one person will preside  is
of no legal significance.   Even when 5 U.S.C. Section  556
requires a hearing to  be presided over by an examiner  (or  a
person representing the Agency), it also specifies that  "one
or more" of those  qualified may preside.

                            -93-

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here to focus  the  issues  in an attempt to implement those


lessons.  At the same  time,  particularly where Congress has

explicitly called  for  formal hearings, the accompanying

rights to reasonable cross-examination and oral presentation

must be preserved.



       All three elements  of these, supplementary procedures

are meant to work  together.1   The use of a panel will ensure

that expert knowledge  is  indeed brought to the task of

making a decision. The provision for preliminary written

submissions will allow that panel to screen the issues and

narrow the formal  part of  the hearing down to those that

are legitimately in dispute and suited to adjudicatory

resolution. Finally, setting a schedule for decision will

help ensure that the potential gains in efficiency reprejj

ted by the first two reforms aro^reaaized in
                          Douglas  M.  costie
                          Administrator
          f ES  2 8 1979
Dated:
                             -94-

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       APPENDIX A
HEARING PANEL

Charles Gregg, Chairperson
Wi11i am Brungs
Robert Coughlin
TECHNICAL SUPPORT PANEL

Robert Chapman, M.D.
Neil Chernoff
Arnold Kuzmack
Dr. James Lichtenberg
ADMINISTRATIVE APPELLATE PANEL

Ronald L. McCallum
Charles R. Ford
Dr. Edwin H. Clark
Ms. Mary Ann Massey
Dr. Richard M. Dowd
Dr. Stephen J. Gage

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