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.
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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.)
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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
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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
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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.
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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
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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
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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
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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
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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-
-------
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-
-------
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-
-------
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-
-------
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-
-------
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-
-------
* /
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
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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
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[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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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.
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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.
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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%.
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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.
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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.
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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.
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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
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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.
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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
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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.
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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
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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
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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.
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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
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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-
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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
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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
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
-------
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
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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 .
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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).
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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.
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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
-------
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.
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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.
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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.
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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
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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.
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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,
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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.
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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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