EPA-440/9-7G-008
CRITERIA .DOCUMENT
MDRIN/DIELDRIN
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Errata
for Mclrin/Dielclrin Criteria Document
p. 5: The first paragraph should read: Based upon the data set forth
herein, it is concluded that a criterion of 0.003 ug/1 should be
adequate for the protection of aquatic life. However, it
cannot be said that any level of aldrin or dieldrin in the
environment is safe for huirans. Therefore, all hurran exposure
should be avoided.
p. 11: Add the following to Table 2:
Sand Shrimp (Crangon septerrispinosa)
Exposure Time (hr) Method LC50 (ug/1) Ref
96 5 8 28
p. 24: Add the following to the end of the last paragraph:
In Lake Michigan in 1968 the concentration of dieldrin was
reported as 1.0 ng/1 (95). Eased on the concentration of
0.10 ng/1 in Lake Michigan alewife sarrples (68), it can be
inferred that the fish have accumulated dieldrin to levels
100,000 time the aifbient water concentration.
p. 25: The last line on this page should read: much as 100,000 tiroes
the dieldrin levels occurring in the v;ater (68.95).
p. 27: The third line, second complete paragraph should begin:
in fish (68, 95).
p. 34: Add reference belay:
95. EPA, 1972. An evaluation of DDT and dieldrin in
Lake Michigan, Ecological Research Series, EPA-R3-72-003,
P. 10.
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ALDRIN/DIELDRIN
TABLE OF CONTENTS
I. Preamble. ]
II. Chemical-Physical Properties 5
III. Toxicological Data 8
a. Mi crobes 9
b. Invertebrates g
c. Fish... ^2
d. Bi rd s j 5
e. Mammals ig
f. Human Health Hazard 19
IV. Environmental Fate and Effects 21
V. Criteria Formulation 25
VI- References 28
Appendix A
Appendix B
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INTRODUCTION
CRITERIA DOCUMENTS FOR TOXIC POLLUTANTS
Scientific rationale and criteria developed pursuant to Section 307(a)
of the Federal Water Pollution Control Act, P. L. 92-500, 33 U.S. C. §§ 1251
et seq., (1972),. for the development and establishment of effluent limitations
for toxic substances are set forth in the following chapters.
Section 307(a)(2) states inter alia that a proposed effluent standard
"..-. shall take into account the toxicity of the pollutant, its persistence,
degradability, the usual or potential presence of the affected organisms in
any water, the importance of the affected organisms and the nature and extent
of the effect of the toxic pollutant on such organisms... " Thereafter, having
considered these factors, the Administrator is to set an effluent standard
for toxic pollutants which provides an ample margin of safety.
In the development of criteria which serve as both the basis and the goal
for the establishment of effluent limits, reliance was placed on the toxicity
data derived from laboratory studies on a range of organisms including
invertebrate, vertebrate, and mammalian test species. These studies
provided extensive acute and chronic toxicity data based-on feeding experi-
ments for a wide range of aquatic organisms and consumers of aquatic
organisms. Environmental studies documenting bioaccumulation in the food
web of the toxic material by the food chain organisms and bioconcentration
by organisms directly from water provided an important component data
base upon which criteria were derived. Appropriate human toxicity data
and mammalian carcinogenic studies, where available, were used also in
developing criteria.
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Aquatic toxicity data generally are obtained by one of two basic
methods, the static and flow-through bioassay. The more traditional
static bioassay employs a tank in which the test organisms are living
and to which a given concentration of toxicant is added. Any water
loss due to evaporation is made up by the addition of fresh water. The
flow-through bioassay, which is a more recent development, reflects
more nearly the natural conditions. Concentrations of toxic substances
are constantly maintained and provide a more accurate test of sensitivity
of aquatic species. Water in a flow-through test is replenished constantly
through flushing. Comparative results using the static and flow-through
bioassays demonstrate that flow-through data yield lower toxicity values
for a pollutant than a static bioassay. This fact is demonstrated by
comparative studies as discussed in the endrin document. However,
most of the data available were developed using static bioassays.
Some toxic pollutants are extremely stable and degrade only slowly
or form persistent degradation products. Those pollutants which degrade
rapidly pose a less severe long-term hazard unless their entry to
the environment is continuous. A parent compound, e.g., aldrin, may
rapidly degrade or be altered to a more toxic form, i.e., dieldrin.
Bioconcentration of toxic pollutants is a significant consideration in
the development of criterion. The rate and degree of accumulation in
an animal and the rate of loss from the animal are factors that help
define the potential magnitude of the pollution load problem. As an
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3
example, a pollutant which bioaccumulates presents a hazard both to
aquatic systems and potentially to man or other carnivores associated
with the ecosystem. To satisfactorily manage a persistent or
non-degradable pollutant requires the maintenance of a ceiling for
ambient levels in water which will afford protection to the food chain
and the consumers of aquatic life (animals including humans). The
body burden of toxic pollutants in fish or food chain organisms may
have no outward effect on the species but will affect consumers of that food
level. As an example, the brown pelican, when feeding on endrin-contaminatec
fish may die or suffer species depletion through reproductive impairment.
Data on toxic effects of pollutants are not available for all species
that may be exposed to the toxic pollutant in these complex societies.
Such data would be necessary to ensure protection of the most sensitive
species. It is desirable to know the relative sensitivity of a wide
variety of species in order to have a better estimate of the sensitivity
of the untested, most sensitive species. Because such data are not
available on all species, the range in sensitivity of a small number of
tested species is used to provide a measure of the range of sensitivity
of all species.
The natural aquatic environment includes many kinds and life stages
of plants and animals that are intricately interrelated to form communities.
Criteria are developed to protect these interrelationships and incorporate
aquatic toxicity data for a phylogenetic cross section of organisms as well as
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4- . -
species representative of wide geographic distribution. Chronic
studies are ap.-.important consideration in establishing criteria and require
.studies of at least one generation, i.e.. one reproductive cycle. Use of
an application factor for persistent and bioaccumulated toxic pollutants
represents consideration of a safety factor. As discussed in the
National Academy of Science publication on water quality (p. 185 of
the NAS/NAE Water Quality Criteria -- 1972, GPO-5501-00520), the
.use of an application factor of 0. 01 when applied to acute toxic values
is thought to provide an ample margin of safety for certain chlorinated v
. hydrocarbon pesticides.
Ecological importance of an organism is dependent on the
role the organism plays within the ecosystem and upon its relationship
to the food chain within the aquatic community and to consumers of
aquatic life, including man. Thus, toxicity data for the top carnivores
in a given ecosystem, as well as economically important species such
as trout, salmon, menhaden and shrimp are needed for the development
of a protective criteria level. Toxicity data for organisms such as the
stonefly and Daphnia are of equivalent importance since these organisms
are a food base for higher consumers and are representative of invertebrate
species found in most waters of the United States.
Invertebrate species, such as the stonefly and the Daphnia, are an
indication of the integrity of the aquatic food chain and their presence
may be the controlling factor for the abundance of economically and
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recreationally important predators such as trout, bass or pike. While
these fish may not directly consume the Daphnia or stonefly or, in
fact, even inhabit the same waters, these lower order organisms are
representative of the food chain base supporting predators.
Criteria levels, by their nature, are developed to protect aquatic
organisms and consumers of aquatic life from direct toxic effect when
placed on contact with the toxic pollutants; and, to protect from a
more insidious and even greater danger, e.g., chronic effects.
Chronic effects take the form of reproductive failures or the poisoning
of predators consuming food organisms which have bioaccumulated levels
of toxic pollutants as in the case of the brown pelican and consuming
endrin loaded fish (see Attachment D, Endrin), and a variety of other
physiological effects as discussed in the various documents. Decreases
in aquatic organisms or consumers of aquatic life not always are coupled
to point source discharges of toxic pollutants at concentrations below
acute toxic levels; however, the addition of toxic levels which are not
acutely toxic can achieve the destruction or at least disruption of aquatic
systems by causing reproduction of failure. Hence, the need for application
factors. The relationships between discharges of toxic pollutants and
effects on important organisms of economic and environmental importance
and consumers of these organisms are well documented in the criteria
documents.
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6
An approach to criteria development is to provide ample protection
of the test species on the assumption that the response of these species
will be characteristic of other associated organisms in the aquatic
environment. A number of species have been considered in establishing
a criteria
Use of mammalian systems to determine the carcinogenic potential
of toxicants found in water follows the same principle as use of aquatic
organisms to determine toxicity to fish and other organisms. Carcinogenic
substances pose a special hazard to man through environmental exposure.
Cancer producing substances may reach man by several distinct pathways.
The following four criteria documents for aldrin/dieldrin, DDT and its
metabolites, endrin and toxaphene, represent a survey of the scientific
literature documenting the effects of these toxic pollutants to aquatic
life and consumers of aquatic life including man. A glossary of terms is
provided to define the terms used throughout the documents and will be
expanded as necessary when additional documents are added.
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ALDRIN/DIELDRIN
PREAMBLE
Aldrin and dieldrin have been two of the most widely used domestic
pesticides. They are related chemical compounds of the chlorinated
hydrocarbon family. Although aldrin is used in greater quantity than
dieldrin, aldrin quickly transforms into dieldrin in the environment.
Hence, there is concern with both compounds. The primary use of the
chemicals today is the control of corn pests, although some is used
by the citrus industry.
Aldrin use in the U. S. peaked at 19 million pounds in 1966 but
dropped to about 10. 5 million pounds in 1970. During that same period
dieldrin use decreased from 1 million pounds to about 670,000 pounds.
The decreases have been attributed primarily to increased insect
resistance to the two chemicals and to development and availability
of substitute materials (69). Actions to control the use of aldrin/dieldrin
were taken by the Environmental Protection Agency as early as 1971.
These actions are explained chronologically as follows (69).
In early 1970, based on a concern to limit dispersal of aldrin/dieldrin
in the environment, the U. S. Department of Agriculture cancelled all
registrations for these pesticides in or on aquatic areas.
On December 3, 1970, the Environmental Defense Fund, Inc.
filed a petition with the EPA requesting immediate cancellation and
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suspension of all Federal registrations of aldrin/dieldrin products
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
as amended by the Federal Environmental Pesticide Control Act of 1972,
7 U.S. C.S, §135 et seq, on the basis that these substances cause severe
environmental damage and are potential carcinogens.
On March 18, 1971, the Administrator of the EPA announced that
since the material contained in the petition and in scientific literature
raised a substantial question as to the safety of these products, the
EPA would issue notices of cancellation of all registrations of aldrin
and dieldrin products.
In response to a request by 84 companies whose products would be
affected by the cancellation order, a scientific advisory committee
reviewed the matter and issued a report in March 1972, recommending
that the following uses be disallowed; all applications by aircraft;
all foilage methods in which residues are discharged into waterways
or setting ponds; all uses in structures occupied by humans or livestock;
use on turf except as controlled by trained or licensed pest-control
operators, greenskeepers and nurserymen; any use involving application
in aquatic environments.
Because the Administrator in 1971 declined to suspend all
registrations of aldrin/dieldrin during the pendency of administrative
proceedings relating to the cancellation, the Environmental Defense
Fund petitioned for review of this decision in the D. C. Court of Appeals.
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3
In May 1972, the Court remanded the matter to EPA for further
consideration in light of the advisory committee report, which was
issued on May 28, 1972, [Environmental Defense Fund, Inc.' v EPA,
465 F. 2d 528 (B.C. Cir. 1972)].
In June 1972, an EPA order lifted cancellation of aldrin/dieldrin
for use in deep ground insertions for termite control, nursery dipping
of roots and tops of non-food plants, and mothproofing of woolen textiles
and carpets where there is no effluent discharge. These are the only
registrations being accepted as of the present date. Cancellation of
all other major uses of these chemicals was continued, and suspension
left open.
During the course of the cancellation proceedings substantial evidence
was developed indicating strongly that aldrin/dieldrin pose a severe
hazard to human health as well as to the health of other organisms, and
that it is a dangerous carcinogen. Accordingly, the Administrator
announced on August 2, 1974, his intention to suspend the registrations
and prohibit the production for use of all pesticide products containing
aldrin or dieldrin which were the subject of the still-pending cancellation
proceedings. Following a hearing before EPA's Chief Administrative
Law Judge, based upon detailed and extensive findings of fact and
conclusions, suspension was recommended on September 20, 1974, and
was then ordered by the Administrator on October 1, 1974. The
Administrator's Notice of Intent to Suspend and Findings as to an
Imminent Hazard on August 2, 1974, together with the Recommended
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4
Decision of the Administrative Law Judge of September 20, 1974,
and the Administrator's Opinion and Order on the suspension of October
1, 1!)74, wen; published in tin; Federal llrgiHtrr. Vol. :
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5
Based upon the data set forth herein, it is concluded that aldrin/
dieldrin are harmful to man and aquatic organisms even at very low
levels of concentration. It cannot be said that any level of aldrin
or dieldrin in the environment is safe, and therefore a prohibition of
any discharge is recommended.
I. CHEMICAL-PHYSICAL PROPERTIES
Aldrin (1, 2, 3, 4, 10, 10-hexachloro-l, 4, 4a, 5, 8, 8a-hexa-
hydro-1, 4-endo—5, 8 -exo - dimethanonaphthalene) and dieldrin
(1, 2, 3, 4, 10, 10-hexachloro-6, 7 -epoxy-1, 4, 4a, 5, 6, 7, 8,
8a-octahydro-l, 4 -endo -5-8- exo -dimethanonaphthalene) are chemicall;
related chlorinated pesticides which remain in their toxic form for an
indefinite period of time. Physically aldrin and dieldrin are white
o
crystalline substances with aldrin melting at 104 C and dieldrin melting
o
between 176-177 C. Both are soluble in organic solvents with dieldrin
the least soluble of the two.
Aldrin is metabolically converted to dieldrin. This epoxidation has
been shown to occur in several species including mammals and poultry
(1), houseflies (2), locusts (3), soil microorganisms (4), a large number
of Lepidoptera species (5), freshwater fish (6), a number of freshwater
invertebrates including protozoa, coelenterates, worms, arthropods,
molluscs (7), and lobsters (8). The aldrin molecule is biologically
altered in the environment to a more stable and at least equally toxic
form, dieldrin. Dieldrin is known to be metabolically degraded (9, 89);
however, its persistence in the environment is due to its extremely low
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-7 o
volatility (i.e.,. a vapor pressure of l.~78xlO mm mercury at 20 C)
o
and low solubility in water (186 ug/1 at 25-29 C) (10). In addition, dieldrin
is wxln-imely apolar. resulting in a high affinity for fa I which allows tor its
retention in animal t'ats, plant waxes and other non-polar organic matter
in the environment. The fat solubility of dieldrin results in the progressive
accumulation in the food chain which may result in a concentration in an
organism which would exceed the lethal limit for a consumer species.
The affinity of aldrin/dieldrin for animal tissue, a function of low water
solubility and the high water partitioning coefficient, shows bioaccumulation
is not affected by concentrations of aldrin/dieldrin in water. Many organ-
isms not in direct contact with contaminated water and sediment acc:umu-
lalu aldrin /dieldrin from the food supply. Thin biological concentration
results in tissue concentrations many times those found in the surrounding
environment (16). Concentrations increase in the food chain reaching the
carnivores at the "top" including man.
Dieldrin is probably the most stable insecticide among the cyclodienes
(i.e., isodrin-endrin; heptachlor - heptachlor epoxide). The time required
for 95 percent of the dieldrin to disappear from soil has been estimated to
vary from 5 to 25 years depending upon the microbial flora of the soil
(12). Dieldrin applied at 100 ppm has been shown to persist in soil for more
than 6 years (14), while at 25 ppm in a different soil type, a 50 percent loss
was found after 7 years (15). When applied to sandy soil at a rate of 100 ppm,
residues could be found 15 years later (15). Matsumura and Boush (9) found
that of 577 bacterial isolates collected from areas heavily contaminated with
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dieldrin. 10 isolates would alter dieldrin to 2 to 9 unknown metabolites.
The microbes were members of Pseudomonas. Bacillus and
Trichoderma genera. Subsequent microbiological studies have
revealed that Aerobacter aerogenes also will alter dieldrin similar to
6,7- trans-dihydroxydihdroaldrin (13). Chacko, et^al. (11) tested the ability
of 17 species of fungi and actinomycetes. Though most degraded PCNB or
DDT or both, none degraded dieldrin.
Patil and co-worker in 1972 studied the metabolic transformations of
aldrin/dieldrin by marine algae, surface film, sediments,- and water. They
found the insecticide was not degraded or metabolized in sea water or pol-
luted waters. Some marine algal populations have been shown to degrade
aldrin to dieldrin (89).
Alteration of dieldrin by bacterial systems results in the formation
of at least one acidic product (9). Once in the fatty tissue of organisms,
dieldrin remains stable (16). However, dieldrin can be mobilized from fatty
tissue; for example, when fish are placed in an environment without dieldrin,
there is an elimination from the tissue (17). The elimination rate depends
upon the diet with fasted fish eliminating dieldrin more rapidly than from
fed fish because of the utilization of fat stores (18). The dieldrin
eliminated from the tissues reenters the water and thus become available
for bioconcentration by other organisms. The movement of dieldrin among
organisms, water, and sediment is dynamic, with equilibrium attained when
the chemical concentration is constant.
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II. TOXICOLOGICAL DATA
Toxic effects resulting from the presence of aldrin/dieldrin in water
have been documented for aquatic organisms representing a wide
phylogenetic cross section and geographic distribution. While all test
organisms used may not be universally distributed in the waters of the
United States, they represent types of organisms present in fresh, marine
and estuarine systems throughout the country. Extrapolation from the
effects found in laboratory and field tests is a reliable means for predicting
effects of aldrin/dieldrin on individual organisms and their food chains and
is recognized as such by the scientific community.
It should be noted that LC50 values reported for static tests are
likely to be substantially higher than LC50 values found using flow-through
bioassays. For instance, Earnest et_ aL (93) reported both static and flow-
through 96-hr aldrin TL50 (LC50) values for two species of surf perch,
Cymatogaster aggregata and Micrometrus minimus. The former yielded a
static value of 7. 4 ug/1 and a flow-through value of 2. 26 ug/1, while
Micrometrus minimus yielded a static TL50 (LC50) of 18.0 ug/1 and a flow-
through TL50 (LC50) of 2.03 ug/1. These data suggest loss of toxicant in
static bioassays. Static tests in which dissolved oxygen and toxicant con-
centrations are measured periodically are more reliable than those in which
these parameters are not monitored. The flow-through bioassays more
accurately reflect nature, where "container wall" effects are likely to be
negligible and where the volume of water per fish is much greater.
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9
Toxicological data sho.w aldrin/dieldrin to be acutely toxic to aquatic
invertebrates(27), to fish (91,93), to birds (46), and to mammals (61).
although mammalian acute toxicity is relatively low.
a) Microbes
Information regarding the effects of aldrin/dieldrin on bacterial and
algal populations is limited. Bacterial species carrying out the conversion
of ammonia to nitrate were inhibited when aldrin concentrations were be-
tween 100,000 to 10,000, 000 ug/kg (21). Studies of the effect of dieldrin on
soil bacteria demonstrated a reduction in the numbers of bacteria at soil
pesticide concentrations of between 100 to 1000 ug/1. Recovery of bacterial
populations varied depending upon species, and required from 7 to 28 days
to reach pretreatment numbers and diversity (23). Similarly, diatom species
are able to survive concentrations of dieldrin greater than invertebrates and
vertebrates. A 50 percent reduction in the diatom population resulted from
an application of 12, 800 ug/1 dieldrin (22). However the growth rate of four
types of marine phytoplankton has been reduced 50 percent by dieldrin
concentrations ranging from about 100 ug/1 to about 500 ug/1 (32).
b) Invertebrates
Sensitivity of invertebrate organisms to aldrin-dieldrin is several
orders of magnitude greater than that of microbial organisms.
Dieldrin distributed at 1 Ib/acre in a Florida marsh resulted in a
complete annihilation of the crab population and virtual elimination of
other crustaceans (24).
REGION III LIBRARY
ENVIRONMENTAL PROTECTION AGENCY
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10
Aldrin and dieldrin toxicity to invertebrates is seen in Table 1 and
Table 2, and indicate that both compounds are extremely toxic to arthropods.
Sensitivity of the stonefly, Agroneuria pacifica, to dieldrin in a 20-day
continuous flow bioassay system was 0.2 ug/1 (37). A sensitive marine crab,
Leptodius floridanus, exhibited delay in development at concentrations of 1
and 0. 5 ug/1 dieldrin (38). At 0. 9 ug/1 dieldrin there was a 55 percent mor-
tality in commercially valuable pink shrimp, Penaeus duorarum, within 96
hours (H4). Dieldrin is more toxic than aldrin to the insect, Pteronarcys
californica. and the crustacean, Gammarus lacustris (30). Aldrin has
been shown, to be more toxic than dieldrin to the crustacea, Simocephalus
serrulatus. and Daphnia pulex (30, 31).
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11
Table 1
Acute Toxicities for Various Invertebrates Exposed to Dieldrin
Species
Exposure
Time (hr)
Stone fly
Stone fly
Stonefly
Stonefly
Stonefly
(Pteronarcella badia) 24
(Ulaassenia sabulosa) 24
(i^teronarcys caiifornica) 24
(Pteronarcys caiitornica') 48
(Pteronarcys caiifornica) 96
Method
S
S
S
S
S
S
S
F
F
F
F
S
S
S
LC50
(ug/1)
3
4.5
6
1.3
.5
1400
Amphipod (Gammarus lacustris) 24
Waterflea (Simocephalus serrulatus) 48
Waterflea (Daphma pulex) ~ 43
Grass Shrimp (Palaemonetes pugio) 96
Pink Shrimp (Penaeus duorarumT 96
Brown ShrimpTPenaeus azTecus) 24
Brown Shrimp (Penaeus aztecus) 48
Sand Shrimp (Crangon septemspihosa) 24
Sand Shrimp (Crangon septemspinosa) 48
Sand Shrimp (Crangon septemspinosa) 96
S: Static Bioassay
K- Flow-through Bioassay
Table 2
Acute Toxicity for Various Invertebrates Exposed to Aldrin
Ref.
27
27
27
27
27
29
240{EC50) 31
250(EC50) 31
8.64 . 34
0.7 34
25(EC50) 90
5. 5(EC50) 90
68 28
10 28
7 28
Species
Exposure
Time (hr)
Amphipod (Gammarus lacustris) 24
Sand Shrimp (Qrangon septemspinosa) 24
Sand Shrimp (urangon septemspinosa') 48
Hermit Crab (Pagurus longicarpusl— 24
Hermit Crab (^agurus longicarpus) 95
Stonefly (Simocephaius serruIamsT 48
Waterflea (baphnia pulelc) ~~~~ 43
Method
S
S
S
S
S
S
S
LC50
ug/1
45
30
14
300
33
Ref.
29
28
28
28
28
23(EC50) 31
28(EC50) 31
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12
c) Fish
When exposed to dieldrin at 1.35 ug/1 for four days, estuarine fish,
LeioHtomuH xanthurus, were found to have degenerative change3 in gills and
vi3ceral tissue (34). Growth rates and reproductive performance of the sailfin
molly, Poecilia latipinna. were adversely affected during a 34-week exposure
to 0.75 ug/1 dieldrin (35).
Cairns et al. (36) found that in the first two or three months of exposure
to concentrations of dieldrin ranging from 1. 8 to 10 ug/1 guppy populations
increased more among exposed groups than among controls. The authors
attributed this to decreased predation by adult fish on the young. After about
six months this population difference disappeared, apparently because the
exposed groups were less successful reproductively. Growth rates of rain-
bow trout, S. gairdneri, were reduced by dieldrin concentrations in water
of 0. 12 ug/1 and above, but eggs survived at concentrations of 52 ug/1 (42).
The LC50 for various fish species is seen in Table 3 for aldrin and in Table
4 for dieldrin.
Table 3
Toxicity of Aldrin to Various Fishes
Exposure
Species Time (hr)
Rainbow trout (Salmo gairdneri)
Jtsluegin (JLepomis macrochirusi
Goldfish (Carassius auratusl
Atlantic siiverside (Menidia menidia)
Allan lie siiverside (Menidia menidia)
Atlantic siiverside (Menidia menidia)
Juvenile White Mullett (Mugil curema)
Bluehead (Thalassoma)
Bluehead (Yhaiassoma)
Stnped miTiiish (Fundulus majalis)
Striped Killinsn (Fundulus majalis)
Striped Killifish (Fundulus majalis)
48
96
96
24
48
96
48
24
96
24
48
96
Method
U
U
U
S
S
S
F
S
S
S
S
S
LC50
ug/1
aldrin Ref.
31
5.2
28
45
20
13
2. 8 (Tim)
15
12
58
26
17
44
44
40
91
91
91
90
91
91
91
91
91
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Cont. of Table 3
13
Toxicity of Aldrin to Various Fishes
Exposure
Species Time (hr)
Striped mullet (Mugil cephalus)
Striped mullet (Mugil cephalus)
American eel (Anguiila rostrata)
American eel (Anguilla rostrata)
Mummichog (Fundulus heteroclitus)
Mummichog (Fundulus heteroclitus)
Northern runer(Sphaeroides maculatus)
Bluehead (Thalassoma bii'asciatmm
Striped Bass (Mo rone saxatilis)
Shiner perch (Cymatogaster aggregata)
Shiner Perch (Cymatogaster aggregata)
Dwarf Perch (Micrometrus minimus}
Dwarl Perch (Micrometrus minimus)
24
48
24
96
24
96
96
96
96
96
96
96
96
Method
S
S
S
S
S
S
S
S
F
S
V
S
F
JLUDU
ug/1
Aldrin Ref.
126
100
18
5
22
8
36
12
7.
7.
2.
18.
2.
91
91
91
91
91
91
91
91
2(TL50)92
4 93
26 93
0 93
03 93
S= Static Bioassay
F= Flow-through Bioassay
U= Unknown
Table 4
Toxicity of Dieldrin to Various Fishes
Exposure
Species Time (hr)
Bluegill (Lepomis macrochirus) 96
Juvenile White Mullet (MugiFcurema) 48
Shiner Perch (Cymatogaster aggregata) 96
Shiner Perch (Cymatogaster aggregata) 96
Dwarf Perch (Micrometrus minimus) 96
L>wari perch (Micrometrus minimus) 96
Atlanuc Silverside (Menidia menidia) 24
Atlantic Silverside (Menidia menidia) 96
Slnped Killiiish (Fundulus majalis) 24
Striped Killifish (Fundulus ma.]alis) 96
Bluehead (Thaiassoma bifasciatum) 96
Srripea Mullet (Mugil cephalus) " 96
American eel (Anguilla rostrata) 48
American eel (AnguiUa rostrata) 96
Mummichog (Funduius heteroclitus) 24
Mummichog (Fundulus heteroclitus) 96
Northern Puner(Sphaeroides maculatus) 96
Striped tsass (Morone saxatilis) 96
Method
U
F
F
S
F
S
S
S
S
S
S
S
S
S
S
S
S
F
LC50
ug/1
Dieldrin
2.8
7.1(TLM)
1. 50
3.7
2.44
5.00
10.
5.
9.
4.
6.
23.
4.
.9
20.
5.
34.
19. 7(TL50)
Ref.
44
90
93
93
93
93
91
91
91
91
91
91
91
91
91
91
91
92
S = Static Bioassay
F = Flow-through Bioassay
= Unknown
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14
Data on the toxicity of aldrin and dieldrin ingested by aquatic or-
ganisms indicate that the compounds can be toxic at water concentrations
of 2. 03 ug/1 and 1. 5 ug/1 respectively (93). Aldrin/dieldrin also has been
reported to alter biological mechanisms of fish. Dieldrin at 0. 36, 1. 08,
3.6, and 10. 8 ug in food fed to rainbow trout for 240 days Salmo gairdneri,
altered brain concentrations of amino acids associated with ammonia de-
toxifying mechanisms, aspartate, glutamate and alanine, as well as the
enzymes related to their metabolism (39).
The 24-hour TL50 (LC50) for rainbow trout, S. gairdneri. exposed to
aldrin has been shown to be temperature dependent and to increases with
increasing water temperature. At temperatures of 1. 6 C, 7. 2 C and 12. 7
C the 24-hour TL50 (LC50) values were 24 ug/1. 8. 1 ug/1, and 6. 8 ug/1,
respectively. Similarly, data for bluegills. Lepomis macrochirus, showed
an effect of temperature. At temperatures of 12. 7 C, 18.3 and C and 23. 8C,
the 24-hour LC50 concentrations were 36 ug/1, 16 ug/1 and 10 ug/1, respec-
tively (43). Data presented in Tables 5 and 6 illustrate that the 24-hour,
48-hour, and 96-hour TL50 (LC50) values are time and temperature related.
Dieldrin has been shown to affect adversely the ability of the freshwater
fish, Etheostoma nigrum, to withstand thermal stress when exposed to a
level of 2.3 ug/1 for 30 days (41). The mortality of those exposed to aldrin
was greater than the non-exposed population. In additon, changes in the
oxygen consumption, whole body lipid and liver condition were affected
adversely in fish after 15 days of exposure. These conditions later returned
to within normal ranges except for liver damage which progressed with time.
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15
Table 5
Effects of increasing temperature and exposure time on
the toxicity of aldrin to bluegill* (44)
Temperature LC50 (ug/1)
F (C)
24-hr. 48-hr. 96 hr.
45 (7.0) 130. 26.4 9.7
55 (12.7) 36.8 12.5 7.7
65 (18.3) 16.4 8.3 6.2
75 (23.8) 9.3 6.7 5.6
^weight of fish approximately 1 g.
Table 6
Effects of increasing temperature and exposure time on
the toxicity of dieldrin to bluegill* (44)
Temperature LC50 (ug/1)
F C
24-hr. 48-hr. 96-hr.
45 ( 7.0 ) 54 34 16
55 (12.7) 40 26 18
65 (18.3) 24 18 14.5
75 (23.8) 14 11 9.3
85 (29.4) 10 8.4 7.1
^weight of fish approximately 1 g.
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16
d) Birds
The dieldrin oral LD50 for the sharp-tailed grouse is reported to be
6. 9 mg/kg of body weight (94). Long-term feeding studies of birds have
resulted in the characterization of a variety of sub-acute and chronic toxic
effects attributable to aldrin and dieldrin, which are typical of the chlorinat-
ed hydrocarbons. Fertility among surviving female pheasants was lower
than in the control group (45). Feeding dieldrin to pheasants at G mg/ per
week for 13 weeks resulted in no mortality in the parents but the offspring
of these hens when fed a diet with 6 mg dieldrin/week for 14 weeks.showed
75 percent mortality. Visual cliff tests also showed adverse behavioral
changes in chicks Hedged from hens fed 8 mg/week for 14 weeks (45).
Pen-reared, 5 week old pheasants were fed with encapsulated aldrin at 0. 5.
1. 0, and 1. 5 mg/week for seven weeks, and another group with 0. 5 mg on
alternate days to a total dose of 1. 5 mg. Treatments of birds between the
ages of 5 and 21 weeks with either 1. 0 mg/week or 1. 5 mg total dose was
found to depress growth. Fifty percent of the birds receiving the 1.5 mg/week
dose died within 48 hours of the first treatment (46).
Dieldrin fed to Japanese quail at dietary levels of 0-40 ppm showed
a definite relationship between dosage and mortality. The highest
no-effect level as measured by growth, health or behavior was 10 ppm.
At higher doses, egg production and fertility were reduced. Hatched
chickes fed dietary levels greater than 10 ppm suffered mortalitites
within 2 or 3 days of hatching (48).
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17
The question of chlorinated hydrocarbons and their effects on avian
calcium metabolism, steroid hormone metabolism and reproduction has
been the subject of numerous investigations which have often resulted in
conflicting data. The major cause of declining predatory bird populations
in the last 20 years has been from a drastic drop in reproduction and not
in the killing of adult birds. The failures in reproduction follow a similar
pattern among the various species and involve delayed breeding or failure
to lay eggs, thinning of eggshells and subsequent breakage, and high mortal-
ity in embroys and newly hatched birds. Recent studies show persistent
organochlorine pesticides induce liver enzymes that lower estrogen levels
and result in late breeding and other related reproductive manifestations (49).
Dieldrin was fed to 43 of 78 nesting female prairie falcons by tethering
dieldrin-contaminated starlings (fed 10 ppm for 14 days) in sight of the
falcons. Birds fed more than three treated starlings averaged dieldrin
tissue levels eight times those of untested falcons. A straightline correla-
tion was found between the amount of dieldrin consumed and the residual
levels in the birds' fat and eggs. Eggshells from 34 untreated birds (egg
dieldrin 1. 9 ppm) were significantly thicker than from seven treated birds
in which egg dieldrin averaged 41. 5 ppm. At dieldrin concentrations of
less than 20 ppm in the egg, there was no difference in the thickness of
eggshells. The data establish a correlation between pesticide residues,
thin eggshells, and poor hatching success (50). Studies of male chickens,
pheasants, and quail exposed to aldrin showed the chemical to have a
feminizing effect on all three. This is thought to be due to reduced
testicular size and altered hormone metabolism (52). Reproduction of
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18
mallard ducks, pheasants, and bobwhite quail was reported reduced or
inhibited by diets containing as little as 0. 5 ppm aldrin (53).
e) Mammals
The LD50 for rats has been reported to be 54 to 56 mg/kg body weight
for aldrin and 50 and 55 mg/kg for dieldrin (61). The oral dieldrin LD50
value for the dog is reported to be 65 to 95 mg/kg (61).
Administration of single oral dose of dieldrin to rats at 30 mg/kg of
body weight resulted in impaired liver function (62). Impaired liver function
also was found to occur in a number of animals species including man (62).
Impairment of reprodution in a variety of mammalian species has been found
to result from exposure to aldrin-dieldrin. A dieldrin dietary level of 100
ppm was found to induce abortion in guinea pigs and was lethal to one-third
of the pregnant and one-half of the non-pregnant animals (64).
Dieldrin has been reported to be transferred from the mother to
blastocyst and from mother to fetus in pregnant rabbits (54). In
continuous feeding studies, neo-natal mortality in dogs and rats has been
shown to increase (55, 56). A level of 2. 5 mg/kg of 85 percent dieldrin
has been reported to produce fetal malformations in Wistar rats (57).
Repetitive oral doses of up to 15 mg/kg dieldrin administered to
pregnant sows during the last 30 days of gestation resulted in placental
transfer to. the embroys. Some degeneration of the kidneys tubules and
slight hepatic lipidosis were osberved in the sows. No lesions were
detected in the fetuses and there were no letal deaths or abortions (58).
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19
Aldrin/dieldrin has also been shown to cause cytogenetic aberration in
mice (59). In two studies comprising five long-term oral studies feeding
dieiann to u.f-i mice at various concentrations, liver enlargements and
tumors were detectable. Appearance of tumors was dose responsive since
tumors occurred 9 months following feed treatment with 10 ppm; 19 months
with 5 ppm; and 23 months with 2. 5 ppm. Further, the total groups all
experienced a decrease in survival rates. At intake rates of 1. 25 ppm and
1 ppm dieldrin, no liver enlargements were detected clinically and survival
was not affected (60).
f) Human Health Hazard
Aldrin and dieldrin are highly mobile and persistent chemicals that are
not lost by dilution or degradation in the inorganic components of the en-
vironment. The pesticides persist in the soil for several years, where
they are absorbed by the roots and transported to the aerial parts of se-
quentially planted crops, such as soybeans and corn. Many of these
products are important feed components for animals. The pesticide
residues are thus incorporated, directly and indirectly, into the milk,
meat, poultry, and soy products consumed by humans (See Appendices
A and B hereto for an extensive discussion of the human hazards).
Evidence that aldrin-dieldrin poses a cancer hazard to man is
provided by the mouse laboratory data. The carcinogencity of aldrin/
dieldrin to mouse strains other than the CF-1 studies mentioned above
(60) have been published (66). Although the liver is the principal organ
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20
affected in the mouse and was a major site of action in rats, there was
also an increase in tumorc of the lungs and other organs (66).
.Aldrin poisoning of humans may occur by ingestion, inhalation and/or
skin absorption. Severe symptons may result from ingestion or per-
cutaneous absorption of as little as 1 gram, especially in the presence of
liver disease. Renal damage, tremors ataxia, convulsions, followed by
central nervous system depression, respiratory failure and death are
symptoms resulting from acute exposure. Chronic exposures over a pro-
X
longed period may result in liver damage (66). In humans, pregnancy
has been observed to offer a degree of protection from dieldrin in-
toxication to the mother, but at the expense of the fetus which concen-
trates dieldrin Ln its tissues (65). . . \
. Chemicals known to cause cancer in man have been identified only
through epidemiological studies, either in the general public or in
occupationally exposed workers. In the case of aldrin/dieldrin.
epidemiological studies have not been possible because there are no
clear-cut differential levels of exposure and because the period of
exposure has been too short. Some cancers in man do not develop
until late in life, usually 20 years or more after initial exposure (66).
Animal studies are accepted as determining factors when assessing the
carcinogenic potential of a chemical to man.
v
Mouse and rat systems are commonly accepted experimental animal
species, both because their relatively short life span permits lifetime
testing within a reasonable period of time and because the pathological
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21
development of tumors in these species is particularly well known and
understood (66). A number of experiments have shown, as noted above,
that aldrin/dieldrin induces cancer in five different strains of mice and
perhaps in the rat. Based on these data this Agency concluded in the
FIFRA proceedings, noted above, that aldrin/dieldrin pose a serious
cancer risk and health threat to man (66).
III. ENVIRONMENTAL FATE AND EFFECTS
Movement of aldrin and dieldrin into the aquatic ecosystem is of
critical importance since, once having entered water, these chemicals
are extremely persistent and toxic. Basically, as with other organo-
chlorine pesticides,' aldrin/dieldrin enters water by one of three routes,
physical transport, chemical transport or biolgical transport. It is
virtually impossible to identify all of the various physical factors affecting
movement of persistent organic chemicals such as aldrin/dieldrin(70)
Characteristics of the soil in which aldrin and dieldrin are found
are of importance in determining the rate of movement of the pesticide.
It has been found that volatilization is one means of loss of these pesticides
from sand and moist soils with low organic content. Temperature is
another parameter of considerable importance, as it has been found that
the half-life of dieldrin in a sandy loam decreased with temperature;
however, this loss apparently is not due to volatilization (71).
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22
Aldrin and dieldrin are persistent in the environment, but aldrin
is readily converted to dieldrin in both living and non-living sites (72).
After its conversion from aldrin, dieldrin is metabolized or degraded
under a variety of circumstances, but generally at a very slow rate.
Some microorganisms, insects and mammals have been shown to
degrade dieldrin and under certain conditions. Sunlight can cause similar
degradation. Overall decomposition rates, however, are inadequate
to prevent its persistence in the biosphere (14). The photoconversion
of aldrin by ultraviolet light should be emphasized, since in nature
residues of this pesticide in sunlight could result in reactions significantly
affecting living organisms. Experimental UV irradiation of aldrin has
been shown to produce dieldrin and aldrin photoconversion isomers
almost quantitatively (73, 74). There is evidence that these isomers
are even more toxic than the original compounds when tested with insects
and fish (75). In general, although aldrin and dieldrin are not highly
reactive chemically in the environment, the reactions they undergo tend
to increase their potential for harmful biological effects (23).
A fundamental fact to be emphasized in considering organochlorine
pesticides in the biosphere is their virtual water insolubility and
high lipid solubility, which facilitates storage by fatty tissues. Aldrin
and dieldrin are preferentially soluble in living (especially lipid)
systems which almost always indicate slower metabolism and turnover
than observed in aqueous interactions (14,16). Microscopic plants
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23
and animals present highly variable responses to aldrin and dieidrin.
Although almost all of them accumulate these chemicals to some extent,
it is probable that they are relatively immune to acute lethal effects.
In algae, aldrin and dieidrin do not build up to levels seen with DDT;
however, 16, 000-fold magnification over the concentration in the medium
has been observed (76). Over 500 bacterial isolates have been studied
from soil and few of them have been found to degrade dieidrin (9). In this
study, Matsumura and Boush concluded:
(1) Dieidrin is one of the most stable and hazardous insecticides
in our environment.
(2) This persistence suggests it is of low biochemical reactivity .
(3) The potent effects of aldrin/dieidrin depend on forming physical
complexes with nervous systems of insects and mammals.
(4) Most chlorinated hydrocarbon insecticides have little effect on
bacterial and fungal growth.
(5) Many microbial changes brought about by application of these
insecticides to soil may be attributable to secondary effects.
As noted above, the extent of lipid metabolism probably is a decisive
parameter in bioaccumulation of these substances as evidenced by laboratory
studies which show concentration factors for dieidrin from water of 114,935
in snails, 7,480 in algae, 6,145 in fish, 247 in crabs and 1,015 in clam (16).
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24
Parrish (34) reported whole body residues in spot (Leiostomus xanthurus)
as much as 6,000 times water concentration in 11 to 18 days' exposure.
The alga, Scenedesmus obliguus. the waterflea, Daphnia magna, and
theguppy. Poecilia reticulata. have been found to accumulate dieldrin
directly from water. The average concentration factors (concentration
in organisms, dry weight, divided by concentrations in water) were 1,282
for algae, 13, 954 for D. magna, and 49, 307 (estimated) for the guppy
(79). The amount accumulated by each species at equilibrium was
directly proportional to the concentration of dieldrin in water. Accum-
ulation of dieldrin by guppies resulted from exposure to either con-
taminated water or to their food source, which was Daphnia magna (79).
The ostracod. Chlamydotheca arcuata. has been shown to accumulate
dieldrin at levels of 12, 000 to 260, 000 times that of the initial theoretical
concentration in water (77).
Studies on degradation of dieldrin by biological systems other than
microbial have been also relatively unsuccessful. Because of these find-
ings it has been concluded that ho biological systems are important in
reducing the actual toxicity of dieldrin entering their metabolism (9).
Residues of aldrin and dieldrin have been found in most molluscs,
fishes, birds and mammals studied regardless of location in the
world (19, 20). Rainwater, drinking-water, and non -potable waters in
Hawaii were sampled and found to contain dieldrin in the low parts per
trillion range (78). . .
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25
Aldrin-dieldrin intake in mammalian systems has been shown to
cause liver damage, kidney damage, and behavioral disturbances
(10, 58, 60, 62, 80).
Data from laboratory studies using mice have demonstrated that
dieldrin is a potent carcinogen (60, 10) and potential carcinogenic danger
to humans experiencing intake of low dieldrin levels from either food
or water has been established (66).
IV. CRITERIA FORMULATION
The persistence, bioaccumulation potential and carcinogenicity of
aldrin-dieldrin make avoidable human exposure unreasonably hazardous.
A chronic criterion .003 ug/1 would provide for the protection of aquatic-
life.
Aldrin-Dieldrin has been found to be toxic to aquatic organisms at
low levels. The Aldrin-Dieldrin 96-hr LC50 to fish is reported as low
as 1. 50 ug/1 for shiner perch, Cymctogaster aggregata (93). The 96-
hr LC50 for striped mullet, Mugil cephalus is 23 ug /I, (91), and for
the striped bass, Morone saxatilis the 96-hr TL50 (LC50) has been shown
to be 19.7ug/l (92).
Residue accumulation of dieldrin and aldrin is well documented.
Levels of dieldrin in fish tissue from Lake Michigan have been as
much as 100,000 times the dieldrin levels occurring in the water (68).
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26
Laboratory exposures of fish, invertebrates, and algae have indicated
that residue accumulation of aldrin and dieldrin is significant. The
reticulate sculpin (Cottus perplexus) exposed to 0.017 ug/1 dieldrin in
water for 32 days developed tissue concentrations of 50, 000 times the
water exposure level (82). The sailfin molly (Poecilia latipinna) exposed
for 34 weeks to 12, 6, 3, 1.5 and 0. 75 ug/1 dieldrin in water concentrated
dieldrin in all tissues at least 10,000 times (35). At the termination
of a 64-week exposure of the Ostracod (Chlamydotheca arcuata) to water
concentrations of aldrin at 0. 01 and 0.10 ug/1 and dieldrin at 0. 01 and
. 10 ug/1. dieldrin recovered from the tissue {dry weight basis) were
12,000 to 260,000 times the initial theoretical water concentrations (77).
In a model ecosystem study, residue accumulation factors for dieldrin
were determined, to be 114, 935 times water concentration for the snail,
7,480 times water concentration for algae, 6, 145 times water concen-
tration for fish, 2,145 times water concentration waterfleas, Daphnia, sp.,
1, 280 times water concentration for a pond weed, Elodea, and 247 times
water concentration for the crab, and 1,015 times water concentration
for the clam (16). Other bioaccumulation studies have indicated similar
uptake levels (76, 79, 83. 84).- With dieldrin at a concentration of 0. 5
ug/1, the rate of uptake by the crab larvae (Leptodius floridanus) in 18 days
was 0.191 ug/g per day from, water (85).
In long-term feeding studies, 1 mg/kg dieldrin affected reproduction
in the Hungarian partridge (86). Slight eggshell thinning was noted in
-------
27
. '• mallard ducks fed a diet containing 1.6 ppm (mg/.kg) of dieldrin (07).
'Deer were affected adversely by long-term feeding of a diet containing
'-.* •* " ' • . , .
.' _r 5 ppm (mg/kg) of dieldrin (88). . ., ';.'. •'. " •
. The highly mobile and persistent nature of'aldrin-dieldrin, as well as
•. its capability for becoming incorporated into products consumed by
• • humans, results in an imminent human health hazard in view of its
• carcinogenicity. Walker, et al. (60) demonstrated'.the tumorigenie
•:"'-: • activity of dieldrin to CF-1 mice. Levels which resulted in rumor %
"•• formation can be found in aquatic food chain organisms as a result of
bioaccumulation from water. ' ' '•".•'".'•• '•/••• '•"'•:•
: . . Bioaccumulation studies with aldrin-dieldrin have shown that tissue
'. . residues up to 100,000 times the ambient water concentration occur
in fish (68). Since the FDA tissue residue guideline for aldrin/dieldrin
is 0. 3 ug/1, water levels higher than.003 ug/1 could result in ' •
... bioaccumulation to levels above .3 ppm in fish flesh. Therefore the
-.. chronic criterion for aquatic life is set at.003 ug/1. The primary impact
•- . . of this bioaccumulation in fish and their food sources centers on the
• '• biological transport of aldrin-dieldrin to birds and mammals including man.
The chronic toxicity criterion^ of 0.003 cg/1 is based on toxicity factors
apart fruu carcincgenicity. • _ "
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28
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aldrin on young pen-reared pheasants. Jour. Wildl. Msmt
3J5:429. 6
48. Walker, A. I. T. , C. H. Neill, D. E. Stevenson and J. Robinson.
1969. The toxicity of dieldrin (HEOD) to Japanese quail (Coturnix
coturnix japonica) Toxicol. Appl. Pharmacol. 1_5:69.
49. Peakall, D. B. 1970. Pesticides and the reproduction of birds
Sci. Amer. 222:73.
50. Enderson, J. H. and D. D. Berger. 1970. Pesticides: Eggshell
thinning and lowered production of young in prairie falcons
Bio. Sci. 2£:355.
52. Lutz-Ostertag, Y. and H. Lutz. 1969. Preliminary note on the
estrogemc effects of "aldrin" on the urogenital tract of the
bird embryo. Compt. Rend. ; Res. D. 269(4): 484. Health Aspects of
Pest. Abst. No. 70-0627. H
53. Chichester, C. O. (editor). 1965. Research in pesticides.
Academic Press, New York.
54. Hathaway, D. E. , J. A. Moss, J. A. Rose and D. J. M. Williams.
1967. Transport of dieldrin from mother to blastocyst and from
mother to foetus in pregnant rabbits. European Jour. Pharmacol.
1 :167.
55. Treon, J. F. and F. P. Cleveland. 1955. Toxicity of certain
chlorinated hydrocarbon insecticides for laboratory animals with
special reference to aldrin and dieldrin. Agric. Food Chem'.
o :
56. Kitselman, C. H. 1953. Long term studies on dogs fed aldrin and
dieldrin in sublethal dosages, with reference to the histopathological
findings and reproduction. Jour. Amer. Vet. Med. Assn. 123:28.
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32
57' B°iUQC7anrd VM* ' L S> Beaulaton- R- Mestres. M. Allieu and S. Cabane.
duration of treatment.
58. Uzoukwu M. and S. D. Sleight. 1972. Effects of dieldrin in pregnant
sows. Jour. Amer. Vet. Med. Assn. 160:1641.
59. Markarjan D. W. 1966. Cytogenetic effect of some chlororganic
insecticides on the nuclei of mouse bone-marrow, cells
Geneticla. 2_;132. .
60. Walker A/ 1. T.. E. Thorpe and D. E. Stevenson. 1972. The
riT,l0gyTr0f^ldrin.(HEOD)- L Long-term oral toxicity studies
in mice. Food Cosmet. Toxicol. 1£:415.
61. Spector W. S. (ed. ) 955. Handbook of toxicology. Volume 1- Acut-
1C
NASr °W,3' qUS 8nd Ga3eS t0 Lab°-tory Animas
NAS-NRC. W.B. SaundersCo., Philadelphia, pp. 14,15,96,97.
62. Bhatia S C. S. C. Sharma and T. A. Venkitasubramaniam. 1972.
Effect of dieldrin on certain enzyme systems of rat liver Br
Jour. Exp. Pathol. _53:419.
64. Uzoukwu. M. and S. D. Sleight. 1972. Dieldrin toxicosis- Feto-
toxicosis, tissue concentrations, and microscopic and ultrastmctural
changes in guinea pigs. Amer. Jour. Vet. Res. 33_:579.
65. Nowak W. W. Lotocki. H. Szrzedzinaki. A. Strasiewicz and
J. Badurski. 1971. Dieldrin poisoning during pregnancy Pol
Tyg. Lek. 2_5:958. Health Aspects of Pest. Abst. No. 72-0532*.
66. Shell Chemical Company, et al. Recommended decision of
Administrative law Judge. "EPA FIFRA Docket Nos. 1*5 etc 39 F R
37246-37265 (October 18. 1975). Reprinted in Appendix A hereto.
68- R • -
70. Peterle T j 1959. Translocation of pesticides in the environment.
CL biological impact of pesticides in the environment --a symposium
ln S1^lficaCe °f Pesticid" in relation to
hlt n o coogcaoe
h^A* En+vf°n^ental Health Series No. 1. Proceedings Sf syrAposiurS
held August 18-20, at Oregon State Univ.. Corvallis, Oregon. Pl-210
71. White, A. W 1970. The influence of moisture, temperature, and
A^T dlf PPearance of ii^dane and dieldrin from soil.
Abstracts International. 30:5327
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33
73. Rosen, J. D. and D. J. Sutherland. 1967. The nature and toxicity
of the photoconversion products of aldrin. Bull. Environ. Contam.
and Toxicol. 2_:1.
74. Crosby, D. G. and K. W. Moilanen. 1974. Vapor-phase photo-
decomposition of aldrin and dieldrin. Arch. Environ. Contam.
and toxicol. 2_;62.
75. Georgacakis, E., S. R. Chandran, and M. A. Q, Khan. 1971.
Toxicity-metabolism relationship of the photoisomers of cyclodiene
insecticides in freshwater animals. Bull. Environ. Contam. Toxicol
6_:535.
76. Rice, C. P. and H. C. Sikka. 1973. Fate of dieldrin in selected species
of marine algae. Bull. Environ. Contam. Toxicol. 9_:116.
77. Kawatski, J. A. and J. C. Schmulbach. 1971. Accumulation of
insecticide in freshwater ostracods exposed continuously to sub-
lethal concentrations of aldrin or dieldrin. Trans. Amer Fish
Soc. :565.
78. Bevenue, A.. J. W. Hylin, Y. Kawano, and T. W. Kelley. 1972.
Organochlorine residues in water, sediment, algae and fish,
Hawaii--1970-1971. Pest. Monit. Jour. £:56.
79. Reinert, R. E. 1972. Accumulation of dieldrin in an alga (Scenedesmus
Obliqus), Daphnia magna and the guppy (Poecilia reticulataTi jour.
Fish. Res. Bd. Can. 29:1413.
80. Avar, P. and G. Czegledi-Janko. 1970. Occupational exposure to
aldrin: Clinical and laboratory findings. Brit. Jour. Ind. Med
27_:279.
82. Chadwick, G. G. and R. W. Brocksen. 1969. Accumulation of
dieldrin by fish and selected fish-food organisms. Jour. Wildl
Mgmt. 33_:693.
83. Johnson, B. T. , C. R. Saunders and H. O. Sanders. 1971.
Biological magnification and degradation of DDT and aldrin by
freshwater invertebrates. Jour. Fish. Res. Bd. Can. 28_:705.
84. Petrocelli, S. R., A. R. Hanks, and J. W. Anderson. 1973. Uptake and
accumulation of an organochlorine insecticide (dieldrin) by an
estuari.ie mollusc Rangia cuneata. Bull. Environ. Contam. Toxicol.
1£:315.
85. Epifanio, C. E. 1973. Dieldrin uptake by larvae of the crab
Leptodius floridanus. Marine Biology. 19;320.
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34
86. Neill, D. D., etal. 1969. 58th Annual Meeting Poul. Sci. Assn. 76.
87. Lehner, P. N. and A. Egbert. 1969. Dieldrin and eggshell thickness
in ducks. Nature. 224;1218.
88. Murphy, D. A. and L. J. Korschgen. 1970. Reproduction, growth,
and tissue residues of deer fed dieldrin. Jour. Wildlife Mgmt.
34:887.
89. Patil, K. C., F. Matsumura, and G. M. Boush. 1972. Metabolic
transformation of DDT, dieldrin, aldrin, and endrin by marine
microorganisms. Environ. Sci. and Tech. 6_:631.
90. Butler, Philip A.. Commercial fisheries investigation. In: '
Pesticide Wildlife Studies: A Review of Fish and Wildlife Service
Investigations During 1961 and 1962, U.S. Dept Interior, Fish and
Wildlife Service Circular 167, pp 11-25.
91. Eisler, R. 1970. Acute toxicities of organochlorine and
organophosphorus insecticides to estuarine fishes, In: Technical
Papers of the Bureau of Sport Fisheries and Wildlife, No. 46, U. S.
Government Printing Office, Wash. D.C.
92. Korn, S.,. and R. Earnest, 1974, Acute toxicity of twenty
insecticides to striped bass, Mo rone saxatilis. Calif. Fish and
Game 60: 128.
93. Earnest, R., and P. E. Benville, Jr. 1972, Acute toxicity of
four organochlorine insecticides to two species of surf perch,
California Fish and Game. 58: 127.
94. McEwen, L. C., and R. L. Brown, 1966. Acute toxicity of
dieldrin and malathion to wild sharp-tailed grouse. Jour.
Wildlife Mgmt. 30:604.
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GLOSSARY
Acutely toxic: Causing death or severe damage to an organism by
poisoning during a brief exposure period, normally ninety-six
hours or less.
Anadromous fishes: Fishes that spend a part oF their lives in seas
or lakes, hut as<-r;nd rivers and streams at certain intervals to ..
spawn. Kxamples are sturgeon, shad, salmon, trout, and
striped bass.
Application Factor: The ratio of the safe concentration to the lethal
concentration as determined for- potential aquatic pollutants
administered to species of interest.
Bioaccumulation (Hioconcentration): The phenomenon wherein elements
or compounds are stored in living organisms because elimination .
Fails to match intake.
('ureinogenir : Producing (lancer.
Catadromous Fishes: Fishes that feed and grow in Fresh water, but
return to the sea to spawn. The best example is the American
eel.
Chronically toxic: Causing death or damage to an organism by
poisoning during prolonged exposure, which, depending on the
organism tested and the test conditions and purposes, may range
from several days, to weeks, months, or years, or through a
reproductive cycle.
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36
EC50: The concentration at which a specified effect is observed
under the test conditions in a specified time? in fifty peivc-nt of
UH: or-gunisms lusted. Examples of specified HTeH.s ;irr lirmor-
rhaging, decreased feuding, dilation of pupils, and altci—d
swimming patterns.
Epilimnion: That region of a body of water that extends from the
surface to the top of the thermocline and does not have a permanent
temperature stratification.
Mow-through bioassay: An assay system in which aquatic species
arc (.-xposed to toxicants in a constantly flowing system, and where
the toxicant is replenished continuously or di.scontinuously.
Hardness (water;: rne concentration of the polyvalent metallic ions
dissolved in water. Unually it. is reported as the equivalent
concentration of calcium carbonate (CaCQ ).
:*
llyperplasia: Abnormal multiplication or increase in the number
of normal cells in normal arrangement in a tissue.
Hypolimnion: The region of a body of water that extends from the.
bottom of the thermocline to the bottom of the water body and
is essentially independent of most surface phenomena.
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37
LC25: The conc'entration of n toxicajit that is lothal (fata!) to twenty-
five percent of the organisms tested under the test conditions in
a specified time.
L(!.r>0: The ronreritralion of a loxicanl which is lethal (I'alnP to
fifty peree.nl. of the organisms tested under UK.' test condiLions
in a specified time. II is virtually identical wit.h TLui and TLT)0.
LU50: The dose of a toxicant that is lethal (fatal) to fifty percent
of the organisms tested under the test conditions in a specified
time. A dose is the quantity actually administered to the
organism and is not identical with a concentration, which is the
amount of toxicant in a unit of test m'edium rather than the
amount ingested by or administered to the organism.
Liter (I): The volume occupied by OIK.' kilogram of water at a pressure
o
of 7(>0 mm of mercury and a lempc-rature of 4 ('. A liter- is
1. 057 quart.
Methylmercury; Mercury which has been methylated, usually through.
some biological agent, such as bacteria.
Microgram per liter (ug/1): The concentration at which one millionth
of a gram (one microgram) is contained in a volume of one liter.
Where the density of solvent is equal to one, one ug/1 is equiva-
lent to one part per billion (ppb) or one microgram per kilogram
(ug/kg).
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38
Microgram per kilogram (ug/kg): The concentration at which one
millionth of a gram (one microgram) is contained in a mass of
one kilogram. A kilogram is 2. 2046 pounds.
Milligram per kilogram (mg/kg): The concentration at which one
thousandth of a gram (one milligram) is contained in a mass '>!'
one kilogram. A gram contains 1000 milligrams.
Milligram per liter (mg/l): The concentration at which one milligram
is contained in a volume of one liter. Where the density of the
solven.t is equal to one, one mg/1 is equivalent to one part per
million (ppm) or one milligram per kilogram (mg/kg).
Milliliter (ml): A volume equal to one thousandth of a liter.
Nanogram per liter (ng/l): The concentration at which one billionth
of a gram (one nanogram) is contained in a volume of one liter.
Where the density of the solvent is equal to one, one ng/1 is
equivalent to one part per trillion or one nanogram per kilogram
(ng/kg).
Neoplastic: Describing any new and abnormal growth, such as a tumor.
Part per million (ppm): A concentration in which one unit is contained
in a total of a million units. Any units may be used (e.g., weight,
volume) but in any given application identical units must be used
(e.g. , grams per million grams or liters per million liters).
Where the density of the solvent is one, one part per million is
equivalent to one milligram per liter.
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39
Parts per thousand (o/oo): A concentration at which one unit is
contained in a total of a thousand units. The rules for using
this term are the same as those for parts per million. Normally.
this term is used to specify the salinity of estuarine .or sea waters.
Piscicide: A substance used for killing fish.
Static bioassay: A bioassay in which the toxicant is not renewed during
the test.
Thermocline-: That layer in a body of water where.the temperature
difference is greatest per unit of depth. It is the.layer in which
the drop in temperature is I ?:. or greater pet-meter of depth.
Tl.ni - Median Tolerance Limit: The: concentration of a test matc.rh.I
at which fifty percent of the test animals are able to survive
under test conditions for a specified period of exposure. It is
virtually synonymous with LC50 and TL50.
TLF)0: Synonymous with TLm and virtually synonymous with LC50.
Tumorigenic: Causing or producing tumors.
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40
Appendix A
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41
NOTICES
[PRL 278-7; FtFRA Docket Nos. 145 etc.]
SHELL.CHEMICAL CO. ET Al_
Consolidated Aldrin/Dieldrin Hearing
On August 2, 1974, I Issued my Notice
of Intent to Suspend the registrations of
certain pesticide products containing
Aldrln and Dieldrin, After an adjudica-
tor? hearing, the Chief Administrative
Law Judge of this Agency on Septem-
ber 20, 1974, issued a recommended deci-
sion concerning the allegations con-
tained in that Notice of Intent to
Suspend. On October 1, 1974,1 Issued my
Opinion and Order. The three documents
are published herewith.
Dated: October 8.1974.
RUSSELL E. TRAIN,
Administrator.
• [FJ.F.R.A. Dockets Noa. 145, etc.]
SHELL CHEMJCAJ. Co. ET .VL.
NOTICE Of Cn'ENTlOiT TO SUSPEND AND
JTNDINCS AS TO AN IMMINENT HAZAJU
In the matter of Shell Chemical Company.
et aU Registrants (Consolidated Aldrln/
Dieldrin Hearing) F.U.R.A. Dockets Nos.
145 etc.
By this ordef. Issued pursuant to section
6(c) of tho Federal Insecticide. Fungicide.
and RodenUcide Act. 33 amended ("Kli'RA"),
I am hereby serving notice of my Intent to
suspend the registrations nnrt prohibit tho
production for use of all pesticide products
containing Aldrln or Dieldrin which are sub-
ject to and for which appeals wero duly filed
from the Aldriu/Dleldrtn cancellation order
Issued by the Administrator of the Environ--
mental Protection Agency on Juno 26, 1972.'
This suspension order Is effective within flve
days unless the registrants request an ex-
pedited hearing pursuant to section 6(c) (2),
with the added provision that I am per-
mitting, pursuant to section 15 (b) (2), use
or sale of existing formulated stocks of pes-
ticides containing Aldrln or Dieldrin which,
are on band as of tho effective date of tho
suspension order. Such hearing. If requested.
shall take no longer-than IS days from tho
commencement of the hearing, unless, for
good cause shown I extend that time for no
more than 5 additional days
Background. The history of prior attempts
to regulate the sale and use of Aldrln and
*In the matter of Seen Co.. et al.,
I.P.&K. Docket No. 145 etc.. FJFL. Vol.
39, No. 126. at .p. 13304 (published
June 29, 1972). For purposes of clarifi-
cation, the result of a final" order of sus-
pension will be to prohibit tho manu-
facture of Aldrln or Dloldrlu for any uso
except for the three uses permitted by the
June 28. 1972. order. Those three exempted
uses are: Restricted termite use, tho dipping
of roots and tops of non-food plants and use
In a total effluent-free mothprooong system.
S
FEDERAL RJEGISTER. VOL 39, NO. 203—FRIDAY, OCTOBER 18, 1974.
-------
D .a'Is both lengthy and involved. The
•original petition for the cancellation and
Immediate suspension of all uses of Aldrln
and Dleldrln was filed by the Environmental
T>elense Fund (HDP) on December 3, 1970.
Shortly thereafter, on March 18,1971, the Ad-
jnini.tT.-xf.nl- of EPA announced the Issuance-
~of appropriate notices of cancellation based
on a ^r.rjtng of "a substantial question as to
the safety" ot AldrLa and Dleldrla. At the
same time the Administrator concluded that
current uses of the compounds did not pose
"an imminent hazard to the public," as that
standard was Interpreted In that Order, and
he thus refrained from ordering a suspension
of the compounds pending completion of the
administrative procedure of review provided
by the governing statute, the Federal Insec-
ticide. Fungicide, and P-odentlclde Act
(PTFRA). 7 U.S.C. IS 135 et seq.. since
amended by Pub. L. 92-518. 86 Stat. 973,
Octofc-er 21. 1972 (FIPRA-&mended). The
Administrator's failure to suspend the regis-
trations prompted the filing by EDF of a peti-
tion for review In tha UjB. Court of Appeals
Jot the District of Columbia. A decision was
Issued by the Court of Appeals on May 6,
1972. "Environmental Defense Fund v. En-
vironmental Protection Agency," 465 F.2d.
828 (1972). In that decision the Court re-
manded the record to EPA for further re-
consideration of tha Issue of suspension. In
light of the judicial Interpretation of the
power of suspension enunciated In the de-
cision and the recently released Aldrln/Dlel-
drln scientific Advisory committee report.'
Tha Court specifically called upon EPA to ex-
plicate the' nature and extent of evidence
available on the carclnogeniclty of Aldrln/
Dleldrin.
On June 23, 1972, upon review of the sci-
entific advisory committee report and all
e • available data the Administrator reaf-
1 d the cancellation of nearly all Aldrln/
Dleldrln products. In addition, that same
order solicited views from, the general public
on the question of whether any of the can-
celled uses should also be suspended. Par-
ticular emphasis was given to those methods
of application and formulation (Le., aerial
application and dust formulation) presenting
the most obvious rls'i of widespread unavoid-
able dissemination of the compounds.
On December 7, 1972, the Administrator
announced that Immediate curtailment of all
aerial applications, dust formulations and
use of these products for fire ant control and
In moth proofing systems Involving effluent
discharge had been achieved through the vol-
untary cooperation of those affected Aldrln
and Dleldrln registrants. The Administrator,
in response to the Order of the Court of Ap-
peals, again re-e.tamlned the Issue of STIS-
penslon. Based on a review of the evidence
available at that tlaie the Administrator
again declined to exercise his power of sus-
pension pending the completion of the hear-
ing. His decision was based on the belief that
the current uses did not present a substantial
likelihood that serious harm would be ex-
perienced during the 12-18 months In which
the hearing was expected to be completed.
n Busts /or current re-evaluctlon of sus-
pension. In the Initial Aldrln/Dleldrin can-
cellation Order, former Administrator Wil-
liam D. Euckelshaus stated then that the
Agency would be prepared to re-evaluate the
question of suspension at any later stage In
the administrative proceedings (March 18th
Statement. 1971. p. 12). In this Agency's
brief to the U.S. Court of Appeals for the
District of Columbia filed In response to the
earlier EDF appeal on the Aldrln/Dleldrin
suspension issue, EPA readily acknowledged
•' t: 'The concept of the safety of the prod-
la an evolving one which la constantly
. -ig further refined In light of our Increas-
42
NOTICES
ing knowledge." Indeed, as the Court of Ap-'
pools emphasized In Its opinion remanding
the Aldrln/Dleldrln suspension Issue to this
Agency: "The administrative process Is a
continuing one. and calls for continuing re-
examination at significant Junctures." "En-
vironmental Defense Fund, Inc. v. Environ-
mental Protection Agency." supra, citing
"American Airlines. Inc. v. C-A.3.". 359 P. 2d
624 (en bone), cert denied 385 U.S. 843
(1966).
There Is no question but that the current
proceeding Involving the continued registra-
tion and future manufacture end use- of
Aldrln/Dleldrin products Is at a "significant
juncture." It has been estimated that the
taking of evidence alone In this hearing will
continue for another 4 or 5 months. This
means that a final Agency decision cannot be
expected until sometime In early 1975. Thus,
the time period for a final decision as pro-
jected by the Administrator In December
1972 has grown considerably. Absent this
Order there Is nothing to prevent the manu-
facturer, during the period prior to a final
decision on cancellation, from producing an
additional -estimated 10 million or more
pounds of active technical product Aldiin for
anticipated 1975 sales. This will mean that
after formulation of the technical 'product
over 50 million pounds of formulated final
products will be available for snle and pos-
sible use over the period of the next year. The
manufacturing process which would produce
the Aldrtri/Dleldrln products for sale and use
In 1975 has been scheduled, according to the
sole manufacturer. Shell Chemical Company.
to' begin on September 1. 1974. Shell haa re-
fused to delay voluntarily the manufacture
of these products until completion of the
current cancellation hearing. If after the end
of the cancellation proceeding I decide finally
to prohibit the use of these pesticides and
yet the current manufacturing cycle Is per-
mitted to be completed, the disposal of such
tremendous amounts of these chemicals will
present enormous environmental risks and
problems, discussed further below, which
must be anticipated and avoided by this ac-
tion. Once the- manufacturing process Is
completed such risks are Irrevocably created.
This proceeding Is at a "significant Junc-
ture" In another highly significant sensa In
that an Intense examination of the relevant
evidence over the post year has. brought to
light certain previously -unknown facts,
which have now been reviewed and scien-
tifically documented for the first time. On
March 22. 1974, 'this Agency's OSce of
Hazardous Materials Control, through the-
OfSce of General Counsel, completed Its
presentation of evidence both as to the risks
(human, environmental, and economic)
from continued Aldrln/Dleldrln usage, the
availability of preferable alternative com-
pounds and the projected economic conse-
quences of discontinuation.
It Is clear that a great deal of evidence
was simply not available to former Ad-
ministrator Ruckelshaus at -the tlma of his
re-evaluatlun of the suspension Issue on
December 7, 1072. A brief elaboration of such
evidence Is set forth below In Section HI of
this Order. In addition, one cannot Ignore
events of this summer such as the necessary
condemnation of more than eight million
Dleldrln contaminated chickens (some of
which accumulated levels of Dleldrln as high
as 3 ppm In the fat) In the State of Missis-
sippi. This occurrence highlights a'major
potential problem which will continue to
exist as long as these persistent, highly fat
soluble compounds continue to be used.
While the Incident In Mississippi Is unique
In Its staggering proportions, I am informed
that It Is by no means an Isolated Incident
but affects other Industries as well. Whether
these Incidents are a result of accidents or
misuse, or whether they are a direct con-
sequence of the Intense agriculture-use on
feed and food crops, does not of course alle-
viate the economic consequences which must
be borne by the a£ected Industry or . the
serious potential risks to public health. In-
deed, the regular pattern of such occurrences
would seem to indicate that as long
as Aldrln and Dleldrln continue to be used,
such continuing threats to the public
safety are Inevitable.
m Evidence in support of suspension. In
remanding the suspension Issue to EPA In
May of 1972 the Court of Appeals, as pre-
viously noted, put special emphasis on the
Issue of carclnogeniclty, asking EPA to-
elaborate on the natura and extent of such
evidence. "Environmental Defense Fund, Inc.
v. Environmental Protection Agency," supra.
at 638. Consequently a discussion of the
limited evidence available at that time, i.e.
evidence of liver tumors cause'd by Dleldrln
In a single strain of mouse, constituted the
principle rationale- supporting the Ad-
ministrator's finding of a "risk" amount-
Ing to a "substantial question of safety" but
not "a red light requiring Immediate elimina-
tion of all dleldrln residues In the dlet.">
(December 7, 1972, Order, at 10, fn. 5). The
-Administrator did not elaborate further on
the risks of other toxic effects nor the Issue of
benefits or lack thereof.
I am not required here to make an exten-
sive elaboration with findings and conclu-
sions on the multiple Issues Involved In the
cancellation proceeding. As the Court of
Appeals observed In "Environmental De-
fense Fund T. Environmental Protection
Agency." supra, at 537, "the function of the
suspension decision Is to make a preliminary
assessment of evidence, and probabilities,
not an ultimate resolution of difficult Issues."
Thus, I will outline with specificity why the
best scientific and medical evidence compels
suspension at this time.
Specifically, we have learned the following
pertinent Information: ' -
1. Since the 1970 usage of Aldrln, the last
year for which complete use figures were-
available prior to the Issuance of the Decem-
ber 1972 Suspension Order, the use of Aldrln
has actually Increased from 8.9 million to
11.8 million pounds In 1972. Thus, the con-
tinued decline In use that was anticipated
at that time has not been realized. '
2. For the most recent reporting period, of
Fiscal Tear 1973, the Food and Drug Admin-
istration, In Its market basket survey, reports
that measurable amounts of Dleldrln were-
found In composite samples of 83 percent of
all dairy products, 88 percent of all garden
fruits (except tomatoes, green peppers, cu-
cumbers), 86 percent of all meat, fish, and
poultry samples and In percentages which
range from 12 percent to 42 percent In other
food composites of grain and cereal products,
potatoes, leafy vegetables, -oils, fats and
shortening, and fruit. In the normal diet tho
majority of total Dleldrln Intake Is due to
tho residues In calry products, meat, fish,
and poultry. While actual Dleldrtn Intake
1 levels have shown a slight decline In tho
market basket survey for the years 1971 and
1972, the percentage of major food category
composites found to contain Dleldrln have
'It should be- noted prior to discussion of
the evidence that while Aldrtn use accounts
for nearly 95 percent of the total use-
of the two compounds, Aldrtn la inown ,
to break down quite, rapidly Into Its
metabolite Dleldrln. Consequently, residues
found In the environment are principally
Dleldrln residues; and' thus the hazards
of Dieldrln are- generally focused upon.
Occasionally the two are used Interchange-
ably.
FEDERAL ROISTER, VOL 39, NO. 703—FXIDAY, OCTOBER 13, 1974
-------
actually shown a steady Increase during this
same period.
In addition, air monitoring conducted by
this Agency during the years 1970-72 reveals
that Dieldrln was detected In over 85 percent
of the 3.345 air samples taken nationally, so
that respiration must be considered an addi-
tional source of human Dleldrln Intake.
3. It appears from recent data that vir-
tually every Individual la this country has
Dleldrln stored In the body. Based on the
annual national human monitoring survey
conducted, by this Agency, tissue samples
taken during therapeutic surgery or at
autopsy revealed that In 1970. 96.5 percent
of all individuals tested had detectable resi-
dues of Dleldrln In their adipose tissue, with
an average of 0.27 ppra. For the year 1971.
99.5 percent of all those sampled bad detect-
able amounts that averaged 0.29 pprn.
4. Evidence now available Indicates that
Dieldrln definitely causes significant Li-
creases of tumors In two and probably three
different strains of mice tested. Moreover,
there Is positive evidence of Increased tumor
Incidence when Dleldren was fed la low
doeses to two different strains of rats as
well. Many of these tumors have been diag-
nosed unequivocally bv eminent pathologists
as malignant. There Is further positive evi-
dence at malignancy based on metastasis to
other organs and transplantablllty Into un-
treated host animals. Dleldrln-caused tumors
in both mice and nu appear at a variety of
sites within the body. Including the liver
lungs, lymphold tissue, thyroid, uterus and
m.immary glands. These tumors have re-
sulted at highly statistically significant
levels from dietary dosages as low as 0.1 ppm
In the diet, which Is the lowest dosage ever
tested In any animal species. In short, even
the lowest levels of Dleldrin produced sig-
nificant cancerous effects. Furthermore, the
evidence Indicates that exposure to Dlsldrln
for periods as brief as several weeks is suffi-
cient to cause highly significant carcino-
genic effects In test animals.
This evidence Is considerably more exten-
sive than that Involving the single strain of
mouse discussed lu the December 7. 1972. Or-
der by the Administrator. ThU Is not to say
that a compound should not be considered
carcinogenic because the first and only evi-
dence of carclnogesilclty Is based on the re-
sults of a single experiment la a single strain
of one particular test species. Indeed, such
evidence generally raises a substantial ques-
tion of safety requiring commencement of
cancellation proceedings. Recent observations
made by scientists la the World Health Or-
ganization's International Age:icv for Cancer
Research demonstrate that It Is unlikely that
a compound shown to be carcinogenic In one
species will not similarly be carcinogenic
when adequately tested In another test spe-
cies. The more extensive data which have now
been developed on the carclaogcnlclty of
Dleldrln confirm and augment the original
data from the single strain of mouse. World
cancer experts who have testified at the can-
cellation hearings earlier this year have con-
firmed the very aerlous nature of this evi-
dence.
5. While there Is no known way of ex-
trapolating absolute conclusions from an'l-
mals to man. we do kaow that the basic
overall similarity of the experimental animal
to man from the standpoint of carc'.noge-
nlclty Is clear In principle. The principle is
accepted by U.S. Government Agencies and
private health organizations. While rccoer.ls-
Ing tha fact that exposure to oven the small-
est a.T.ouiH of a carcinogen Is no guarantee of
absolute safety, scientists at the National
Cancer Institute- have devised oue method
'or estimating the degree of cancer rlsi to a
particular carcinogen. These ostlrnates are
derived from the animal cancer test results.
43
NOTICES
Baaed upon these calculations and the neces-
sary assumptions, the present estimated aver-
age human daily dietary Irs'.aie of Dleldrln
subjects the human population to an ex-
tremely high cancer risk.
6. While most or the data with respect to
the estimated dally Intake or Aldrirs/Dleldrln
are computed on ac average basis. It Is ob-
vious that based on differences In dietary
composition somo segments of the popula-
tion will greatly exceed that average. In
fact, we have now learned from a national
dietary survey that young children, particu-
larly Infants from birth to one year of age
because of their high dairy product diets.
consume considerably more Dleidrln on a
body-weight basis than any other age seg-
ment of our population. Evidence from lab-
oratory experiments with test animals has
shown that the newborn Is generally more
sensitive to carcinogens. Therefore. Infanta
exposed to Dleldrln may be subjected to a
considerably Increased risk. It has been
shown that In humans Dleldrln Is transferred
to the fetus during pregnancy. Thus exposure
to Dleldrln begins at the earliest stages of
life.
7. Evidence based upon human sublects Is
virtually Impossible to obtain. The general
human population Is continually exposed to
a multiplicity of chemicals. A significant
"control group" Is thus Impossible to estab-
lish. Moreover, to await the twenty to thirty
years of exposure necessary to determine the
ultimate effect Is only to wait until the dam-
age to an entire generation of humans !s
complete. We reject tho-"bod7 count" ap-
proach to protection against cancer or other
such long term threats to public health. Pre-
• diction based on laboratory testing Is thus
necessary and unavoidable il public health
Is to be protected.
8. There are additional serious questions
as to other tox!cologtcal effects demonstrated
by these compounds which have a bearing on
further human and environmental risks.
•These Include, birth defects caused by Aldrin
and Dleldrln In hamsters and mice-, adverse
etfecta on learning capabilities In monkeys
fed low levels of Dleldrln, adverse reproduc-
tive effects caused by Dleldrln la male and
female dogs and mice and evidence showing
the danger posed to endangered species such
as the bald engle.
9. Finally, there Is no agricultural neces-
sity for the major use of these compounds.
It Is estimated that more than 90 percent of
the total usage of Aldrtn and Dleldrtn Is on
com. According to the most recently pub-
lished U.S. Department of Agriculture statis-
tics, less than 10 percent of the total corn
grain producing acreage In the United States
Is treated with these compounds. On the
acreage where Aldrln Is used, there are en-
vironmentally preferable substitute pesti-
cides, alternative means of pest control or
promising substitutes awaiting Federal reg-
istration.
The number ot additional uses which are
actually bel:ig defended In the hearing Is
quite small. For most of these minor uses
there also are alternative pesticides which
can be utilized. In a few specific Instances
of very minor uses, there may be no reg-
istered alternatives at this time. However.
the provision of this suspension order per-
mitting continued use of already formulated
Aldrln nr.d Dleldrln products will give some
tlmo for the registration of promising en-
vironmentally tolerable- alternatives, where
registrations do not already exist.
As was stated by a subgroup within the
U.S. Department of Agriculture review!:'»
Aldrln/Dleldrln residues In food and feed as
far back as December. 1953:
It is pertinent to cote ar. experience of
about >en years ago when It was'clearly de-
termined'by residue studies that nldrln. dlel-
drln. and heptachlor could no longer be pe--
nlttad to control grasshoppers on western
raagelaad because of meat residue problems
The search for nor.perslstent alternative In-
secticides was stimulated and an elective
organophosphorous Insecticide was found.
Thus, a serious food safety problem was
eliminated. Agriculture la general would not
suffer if aldrin-dleldrin were eliminated from
use on agricultural croas.
Having reviewed the above stated pertinent
factual data as well as all other available
pertinent data, I am persuaded that there
exists an "imminent hazard" within the
meaning of'the statute (as defined by sec-
tion 2(e) of the FIFP.A). It should be noted
that during late 1973 and early 1974 the
Agency star? presented Its evidence on the
cai-clnogenlclty of Dleldrln. During this time
the manufacturer, through counsel, had Its
full resources available for extensive cross
examination of witnesses. The manufacturer
has completed the presentation of most of Its
evtder.ee on other aspects of the case. While
earlier this year It was anticipated that the
responsive evidence on carc'.r.ogenic'.ty would
have already been completed. It cow ap-
pears that this evidence win be presented
during September and October of this vear.
The cancer experts with whom we have "con-
sulted advise us that the rebuttal evidence
thus far proffered by Shell Is unlikely to be
persuasive. Further assessment of the
substantiality of this evidence can be made
at the expedited hearing, Lf the registrants
recuiest such a hearing.
IV Effect of order and considerations given
thereto. I flnd that In light of the evidence
abovo and because of the time this hearing
will take In the future, a situation ex-.sts In
which the manuracuire of A'.drln and Dlel-
drln during the coming months-s-il! be "I'.kely
to result In unreasonable adverse ertect-s" on
man and the environment.5 In consultation
with the sole macafacturer cf Aldrln/
Dleidrln, the- Shell Chemical Company, and
Its fomvulators, a determination' shall be
made as to the precise extent of formulated
products currently on hand as of the date of
this order. Any stocks of technical grade
Aldrln and Dieldrln which have not already
been, formulated Into products may not
henceforth be formulated for use in any
product other than those uses exempted In
the June 26, 1972 order as coiiflrrr.ed In the •
December 7. i972 order.
This Agency is not unawars that certain
particular uses of pesticides can result in a
greater likelihood of unreasonable adverse ef-
fects on the environment than others. Such a
distinction, however. Is particularly dLf.cult
to make wl:h respect to the compounds
A'.drln/Dteldrtn. which are so highly persist-
ent, mobile, lipld soluble and capable of ex-
erting such a broad range of toxic eSects.
Therefore, this order effects all those regis-
tered uses for which appeals were dujy filed
Trom the. June 26, 1972 order (see footnote 1
above).
Finally. I have Invoked the new "Special
Rule." provision of section 15(b) (2) per-
mitting continued use of those existing
stocks of formulated, federally registered
products containing Aldrln or Dlcldrin. It is
held by many of those who have Investigated
the potential risks and problems attendant
to the disposal of consolidated stocks of some
toxic materials, such as these pesticides, th.it
It may well t>e sa-fer environmentally to dis-
pose of them through normal us« patterns
' As further defined by the statute, section
2(bb). the term "unreasonable adverse ef-
fects on the environment" can Include "any
unreasonable risk to man or the er.vl'or.rr.ent
taking into account the economic, svclal. and
environmental costs and benefits of :he use
of any pesticide."
fEDE.IAL REGISTER, VOL 39, NO. 203—FRIDAY, OC7C3E3 13, 1974
-------
44
NOTICES
th __ L to atumpt to retrieve the product from
tha retailer or mer. and then to transport.
consolidate and either bury or burn remain-
ing supplies. Absent Invoking the "Special
Sola", this latt«sr alternative la what would
' • required as present with existing formu-
.aiad stocks. Additionally. It is my under-
standing thai corn farmers have already ap-
plied. Aldrin this past spring, so that there
remains only limited usage on minor crops
• during the remainder of the current grow-
ing seasons. Permitting use of existing stocks
In these situations will not penalize farmers
who have alread7 purchased the compounds
with the erpec'.-.t'.on of using them during
the remainder oi :he growing season.
Accordingly. I Intend to order the sus-
pension of toe registrations and prohibit the
production for use of all pesticide products
containing Aldrin or Dieldrin which were
subject to and for which appeals were duly
filed from the Aldrln/DIeldrln cancellation
order Issued by the Administrator of the En-
vironmental Protection Agency on June 26,
1972 (see footnote 1, above). In the absence
of a request for an expedited hearing, this
order shall b» effective S days after receipt
by affected registrants.
Dated: August 2. 1974.
Russru. E. TRAIN.
Administrator.
[FTFRA Dockets No. .146. etc.)
SHTT.T. CTTKMTCAL COMPANT. ET AI..
STATEMENT BZGAKOrNG
DECISION
These are consolidated proceedings under
the Federal Insecticide. Fungicide, and
Rodentlclde Act. as amended (7 U.S.C. 133
e' i., 1973 Supp.). Pursuant to section 6(c)
c ; act (7 U.S.C.- 136d(c)>. the Admlnls-
tic..or. on August 2, 1G74. Issued a notice of
Intention "to suspend the registrations and
prohibit the production for use of all pesti-
cide produces containing Aldrln or Dieldrin
which are subject to and for which appeals
were duly Sled from the Aldrln/DIeldrln
cancellation order Issued by the Adminis-
trator of tbe Environmental Protection
Age=cy on June 23. 1972." > The notice of
suspension also contained detailed findings
pertaining to the question of "Imminent
hazard" as required by the act.3
"Unreasonable adverse effects on the environ-
ment" is denned in the act to mean "any un-
reasonable rlslc to man or the environment.
1 As explained In the August 2. 1974 no-
tice, a final order of suspension In these
consolidated proceedings would not Include
the 3 uses permitted by the .June 26, 1972
order, that Is, restricted termite use, the
dipping of roots and tops of nonfood plants
and use In a totally effluent-free mothproof-
Ing system. Also, the August 2, 1074 notice of
suspension permitted, pursuant to section
15(b)(2) of the act (7 U.S.C. 136m(b)(2»
the "use or sale of existing formulated stocks
of pesticides containing Aldrln or Dieldrin
which were on hand as of tbe effective date
of the suspension order."
'Section S(c)(l) of the act provides that
'"! '.tie Administrator determines that action
'3 ncressary to prevent an Imminent hazard
i-.;rir\s the tim? required for cancellation or
:hnnse in clruai'cation proceedings, he may.
br order, suspend the registration of the
p*c!!clde Irr.rr.sdlately." The term "Imminent
j-.^'.ard" Is de:'::ied to mean. In part, "u s-.tua-
'.Icti which exists when the continued use of
a nestlctde during the time required for
c llatlon proceeding would be likely to
r> . In unreasonable adverse effects on
its environment (7 U.S.C. 136(1)).
taStlng Into account the economic, social, and
environmental costs and benefits of any use
of any pesticide." (7 TJ.S.C. 138(bb)).
Shell Chemical Company, the sole manu-
facturer of the pesticides Involved, filed
timely objections to the notice of Intention
to suspend and subsequently 22 other regis-
trants also filed objections thereto.' In addi-
tion, the Secretary of Agriculture of the
United States, Environmental Defense Fund,
Inc.. the National Audubon Society, and
Florida Citrus Mutual were granted leave to
Intervene herein pursuant to 3 lS4.121(e) of
the rules of practice (38 FR 19371, 19378).
Section S(c) (l) of the statute further pror
Tides that "No order of suspension may be
Issued unless the Administrator has Issued or
at the same time Issues notice of hla Inten-
tion to cancel the registration or change the
classification of the pesticide." By PR No-
tice 71-4. da-.cd March 18. 1971, and Issued
by the Acting Director of the then Pesticides
Regulation Division, after prior piecemeal
cancellations of registrations of pesticides
containing the Insecticides aldrln and dlel-
drtn. the registrations under ths act of all
registrations of products containing aldrln
and dleldrln were cancelled. Of the 88
registrants who. In effect', appealed the can-
cellation of their registrations by PR Notice
71-4, 2 requested a public hearing and 84
registrants requested that the matter be
referred to an advisory committee selected
by the National Academy of Sciences, which
they could then do under the statute. The
cancellations Involved were not effective
pending the outcome of such appeals. The
Al-lrLn/Dleldrln Advisory Committee to the
Administrator Issued a report March 23,1972,
recommending, In part, that certain uses of
the. pesticides Involved be disallowed, that
enumerated uses thereof are "valuable and
not harmful." that further studies be con-
ducted In specified areas and that a further
review be conducted In the future.
By a Determination and Order dated
June 26, 1972. then required by the statxite,
the Admlnlatrfator aSnned the cancellation
of the registrations of all products containing
aldrln or dleldrln except with respect to those
registered uses Involving the dipping of roots
or tops of nonfood plants, subsurface ground
Insertions for termite control and mothproof-
ing by manufacturing processes which utilize
the pesticide In a closed system, which uses
the Administrator found to "pose de minimus
risks." The Administrator therein deferred
decision on the suspension, as distinguished
from the cancellation, of the aldrln and
dleldrln registrations.
Section 4c of the act (7 TJ.S.C. 135b(c))
then provided that administrative appeals
from the decision of the Administrator to
maintain cancellations In effect may be t_ken
within 60 days from the date of such deci-
sion. Appeals therefrom were taken by the
ftllng of objections thereto and request for
a public hearing by 38 registrants.
The Administrator, by a Determination
and Order dated December 7. 1972, In part,
consolidated Into the cancellation proceed-
ings petitions dealing with tolerances of al-
drln and dleldrln pursuant. In effect, to sec-
tions 406 and 40<< of the Federal Food. Drug,
and Cosmetic Act (21 TJ.S.r. 348 and 340a).
The Administrator also therein declined to
suspend the registrations lr -olved. clarified
his prior order with respect :o permitted uses
> It Is not clear that ail of the additional
legist rein ts flied timely objections and are
properly parties to these proceedings. How-
ever, respondent has failed to file motions to
dismiss In this regard and we are not In
possession of the facts to enable us to decide
this Issue.
and. In effect, lifted the cancellations of
registrations for manufacturing use only.
Oral hearing In the cancellation proceedings
commenced August 7. 1973, and was In prog-
ress when the notice of Intention to suspend
was Issued.*
On August 7. 1974°. Herbert L. Perlman,
Chief Administrative Law Judge, Environ-
mental Protectlor Agency, was appointed the
Presiding Officer In the suspension proceed-
ings. Prehcartng conferences were held Au-
gust 7. 8, 9 and 13. 1974, and the hearing
herein commenced August 14. 1974. The reg-
istrants filing objections to the notice of In-
tention to suspend subsequent to the filing of
objections by the Shell Chemical Company
were consolidated Into the proceeding Insti-
tuted by Shell pursuant to I 164.121 (f) of the
rules of practice and evidence- received In
the cancellation proceedings was Incorpo-
rated by reference Into the suspension pro-
ceedings by the agreement of the parties. In
addition, respondent did not present evi-
dence herein with respect to the matters
contained In paragraph 3 of the August 2,
1974 notice of Intention to suspend dealing
with tozlcologlcal effects of aldrln and dlel-
drln other than cancer, and ganger nosed to
endangered species.
The Administrator ordered .that the hear-
ing herein take no longer than- 15 hearing
days and the hearing closed September ' 12.
1974. The active participants ac the hearing
were represented by tbe following:
William D. Rogers, Andrew 3. Srulwtch.
David H. Lloyd and Linda Blumenfeld, At-
torneys at Law. Washington, D.C., repre-
senting Shell Chemical Company,
Raymond W. Fullerton and Richard S.
Wasserstrom, Office of the General Counsel,
United States Department of Agriculture,
representing Interveoor Secretary of Agri-
culture of the United States; and John A.
Knebel. General Counsel, United States De-
partment of Agriculture, who presented one
witness and made oral argument for this
Intervenor.
William A: Butler and Jacqueline M. War-
ren, Attorneys at Law, Washington. D.C.. rep-
resenting Intervenors Environmental De-
fense Fund. Inc. and the National Audubon
Society, and
John C. KoloJesSU. William E. P.euiauf,
Timothy L. Barker. Edward Lyle, and John
W..Lyon. Office of tbe General Counsel, En-
vironmental Protection Agency, represent-
ing respondent Assistant Administrator, En-
vironmental Protection Agency.
Subsequent to the close of hearing- the par-
ties filed briefs and I hereby submit my rec-
ommended decision within the exceedingly
short period of time provided by the rules of
practice.
FINDINGS OF FACT
1. The registrants In these consolidated
suspension proceedings are as follows:
Agway Inc.. a corporation whose address Is
Box 1333, Syracuse, New York;
AMOCO Oil Company, a corporation whose
address Is 200 East Randolph Drive. Chi-
cago, Illinois:
Arlenge Laboratories, Inc.. a corporation
whose address Is 175 Pearl S'v-it. Brooklyn.
New Tort;
Borden, Inc..*a corporation whose address Is
60 West Broad Street, P.O. Box 2478, Colum-
bus, Ohio;
4 By August 2, 1974. over 24.000 pages of
tit; iscrlpt and many thousand of pages of'ex-
hibits. Including the witnesses' direct testi-
mony, were adduced In, the consolidated can-
cellation proceedings.
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 13, 1974
-------
45
Borderland Products. Inc.. a corporation
whose address Is 560 Fulton Street, P.O.
Box 368, Buffalo, New Tori:
Bonlda Chemical Company. Inc.. a corpora-
tion whose address Is Utlca, New Tort:
C. J. Martin Company, a company whose ad-
dress 13 606 West Main Street, P.O. Box
1089. Nacogdoches. Texas;
Chevron Chemical Company, a company
whose address is 200 Bush street, Saa
Francisco. California:
Coastal Chemical Corporation, a corpora-
tion whose address Is Evans Street. Ex-
tension, P.O. Box 856, Greenville, North
Carolina;
Colorado International Corp., a corporation
whose address Is 5321 Dahlia Street. Com,.
. merco City, Colorado;
Dexol Industries, a company whose address
Is 1450 West 228th Street. Torrance, Cali-
fornia;
Farmland Industries. Inc.. a corporation
whose address Is P.O. Box 7305, Kansas
City. Missouri;
FCX Inc.. a corporation whose address la
P.O. Box 2419, Raleigh, North Carolina.
Helena Chemical Company (Mldsouth Dlvl-
: slon), a company whose address Is P.O.
Box "N", West Helena. Arkansas:
Key Laboratories. Inc.. a corporation whose
: address b Bosklns Crossing. Largo, Flor-
ida;
•' McLaughlln Gormley King Company, a com-
pany whose address Is 1715 S.E. Firth
Street, Minneapolis, Minnesota:
Riverside Chemical Company, a company
whose address la P.O. Box 17119. Memphis.
Tennessee:
Shell Chemical Company, a division of Shell
OU Company, a corporation, whose ad-
dress Is 2401 Crow Canyon Road. Saa
Ramon, California;
'•>uthern Agricultural Insecticides. Inc., a
corporation whose address Is P.O. Box 218
Palmetto, Florid a;
Etauffer Chemical Company, a company
whose address Is 1200 South 47th Street,
Richmond, California;
.Stephenson Chemical Company, Inc., a cor-
poration whose address Is P.O. Box 87188.
College Park, Georgia;
Stevens Industries. Inc., a corporation whose
1 address Is Dawson. Georgia: and
I Triangle Chemical Company, a company
| whose address Is P.O. Box 4528, 206 Lower
I Elm Street, Macon, Georgia.
I 2. The tntervenors In these consolidated
| suspension proceedings are the Secretary of
j Agriculture of the United States.- Environ-
mental Defense Fund, Inc., National
Audubon Society, and Florida Citrus Mutual.
.The respondent herein Is the Assistant
Administrator, Environmental Protection
. Agency.
3. Aldrln Is the common name of a chemi-
• cal compound approved by the International
Organization for Standardization (except In
Canada, Denmark and U.S.S.R.) and by the
British Standards Institution for a material
containing not less than 95 percent of 1,8,9,
10.11.11-hexachloro-2.3-7, 6-endo-2.7.8-exo-
tetracyclo [8.2.1.1»-«.0"] dodec-i.9-dlene. In
Canada, aldrln refers to trie pure compound.
known as HHTJN In Great Britain. It was In-
troduced In the United States In 1948 by
Julius Hyman and Company as Compound
118 under the trademark Octalene. In Decem-
ber 1949. the Insecticide was given the com-
mon name "a'.drln" by the Interdepart-
mental Committee on Pest Control of the
United States Department of Agriculture.
It has been used as a broad spectrum In-
secticide on a variety of crops aad In a wide
variety of locations and situations. Its In-
Bectlcldal action was flrst described by Llclon
•xnder patent number 2.635,977 (this was
ansferred to S.hell Development Company
i 1963), and Schmerllng had patent number
NOTICES
3.911.477 (transferred to Universal OU Prod-
ucts In. 1959). Tho physical properties of the
compound are as follows:
(a) As a pure compound. It Is a white
crystalline odorless solid, with a molecular
weight of 364.93.
(b) It has a melting point of 104-104.5'
Centigrade.
(c) Its vapor pressure Is 2.3U10-»mm of
Mercury at 20' Centigrade.
(d) It is slightly soluble In water (0.0037
mg/100 ml or 2.7x10-* grams per 100 mllLl-
llters of water).
(e) It Is llpophlllc, having a strong at-
traction for fats, and Is fat soluble.
(f) Its colublllty In various substances Is
as follows:
Pentane—3 grams per 100 mllllllters at
25'C.
Ethanol—5 grams per 100 mllllllters at
25'C.
n-Butonol—9 grams per 100 mllllllters at
25'C.
Butanone—24 grams per 100 mllllllters at
25'C.
Amylacetate—30 grams per 100 mlllllKers
at 2S'C.
Acetone—68 grams per 100 mllllllters at
25'C.
Benzene—83 grams per 100 mllllllters at
25' C.
Xylene—92 grams per 100 mllllllters at
25'C.
Ethylenedlchlorlde—105 grams per 100 mll-
1111 ters at 25'C.
Carbon Tetrachlorlde-M05 grams per 100
mllllllters at 25'C.
(g) It Is stable In the presence of organic
and Inorganic alkalies.
(h) Oxidizing agents and strong adds at-
tack the unchlorlnated ring.
(1) Upon prolonged storage, there Is a alow
formation of Hydrochloric acid (HC1) which
causes It to be corrosive.
(J) The technical product Is a tan to dark
brown solid with a melting range of about
49 to 60«C.
(k) It Is a non-systemic and persistent In-
secticide.
4. Dleldrln, a manufactured product and
a metabolic degradation product of aldrln. Is
Hhe common name approved by the Interna-
tional Organization for Standardization (ex-
cept In Canada. Denmark and the U.S.S.R.)
and by the British Standards Institution for
a material containing not less than 85 per-
cent of 1.8.9.10.11.11-hexachloro-4.5 - exo-
epoxy-2.3-7,8-endo-2,l - 7.8 - exo - tetracyclo
[ 6.2.1.l.'-«.0=-'] dodec-9-ene. In Canada dlel-
drln refers to the pure compound, known as
HEOD In Great Britain. It Is used as a broad
spectrum Insecticide and was first Introduced
In 1948 by Julius Hyman and Company as
Compound 497 under the trade name of Acta-
lox. In' December, the Insecticide was as-
signed the common name "dleldrln" by the
Interdepartmental Committee on Pest Con-
trol. It Is classified as a non-systemic and
persistent Insecticide of high contact and -
stomach activity to most Insects. U.S. patents
were granted to Soloway with the patent reg-
istration number of 2.676,131. This was trans-
ferred to the Shell Development Company In
1954. Another U.S. patent was Issued to a
Payne and Smith, patent number 2.776,301
which was transferred to Shell Development
Company In 1957. A British patent number
794.373. was assigned to N. V. Bataa'sche In
1958. Some of the physical properties are as
follows:
(a) The pure compound !s a white odorless
crystalline solid with a molecular weight o(
380.93.
(b) Its melting point Is 175-176' Centi-
grade.
(c) Its vapor pressure Is 1.78x10-' milli-
meters Of mercury (Hg) at 20' Centigrade.
(d) It Is llpophlllc, has a strong attraction
to fats, and Is fat soluble.
(e) Its solubility in various substances is
as follows:
Oil. Standard No. 10—1.3 grams per mllll-
llter at 30' C.
Hexane—2.5 grams per mllliuter at 30' C.
Methanol—3.4 grams per mllllllter at 30' C.
Acetone—35.4 grams per mllllllter at 30' C.
Benzene—38.9 grams per mlllillter at 30' C.
(f) It la slightly soluble la water. 0.188
milligrams In 100 mllllllters of water to say
It In another way, 1.88XH) —«g/loo ml.
(g) Dleldrln Is more stable than aldrln as
Indicated by Its stability when exposed or
combined with alkali and mild acids.
(h) The technical product Is buff to light
brown aake» with a setting point not below
95' C.
5. Beginning In 1950. Shell Chemical Com-
pany became the sole national distributor for
aldrln and dleldrtn and Julius flyman and
Company remained the sole manufacturer.
In May, 1952, Julius Hyman and Company
was amalgamated with Shell as the Julius
Hymau and Company Division of Shell
Chemical Corporation. From 1952 until 1967.
Shell sold only technical aldrin and dteldrln
to pesticide formulators who In turn made
It up Into emulslble concentrate, dust, wet-
table powder or granular formulations for
sale under their own company's brand name.
Beginning In 1967, Shell started selling for-
mulated product under the Shell brand
name. By 1972. only 11 percent of the total
aldrln and dleldrln sold was sold as techni-
cal product for use In non-Shell branded
formulations.
6. Aldrln and dleldrln are toxic to humans.
In the Instance of aldrln, poisoning may oc-
cur by uigestlon. Inhalation, and/or skin
absorption. Severe symptoms may result from
Ingestlon or percutaneous absorption of 1 to
3 grams, especially In the presence of liver
disease. Renal damage, tremors, ataxla. con-
vulsions followed by C.N.S. depression.
respiratory failure and death can occur from
acute exposures. Chronic exposures over a
prolonged period may cause at least hepatic
or liver damage.
7. (a) Approximately 1.5 million pounds
of aldrln were sold In 1950. the year It was
Introduced, practically all of this for use on
cotton. Sales for use on cotton continued to
account for a major portion of the total
aldrin sales until the mld-1950's when the
superior effectiveness of dleldrln against the
boll weevil became widely known. Sales for
use on cotton, particularly In the southeast,
where quick effectiveness between the many
ra.m showers Is a necessity, continued until
the mld-1960's. In 1954, cotton accounted
for 30 percent of the total sales whereas In
1963. the last year of any real cotton use.
It was less than l percent.
(b) Two ounces of aldrln per acre diluted
In dlesel oil was an effective and economical
grasshopper Insecticide and It waa adopted
for all Federal cooperative grasshopper con-
trol programs. By 1954 approximately 4 mil-
lion acres had been treated with aldrla.
Aldrln remained the Insecticide of choice un-
til the late 1950's when dleldrln at 0.5 ounce
per acre became the Insecticide of choice
and was used until the mld-1960:s. In 1954.
use for grasshopper control programs ac-
counted for approximately 16 percent of total
sales but decreased to less than 1 percent
In the early 1960's. In addition to the use
cf aldrln In the Federal grasshopper control
programs, substantial quantities' of aldrln
(and dleldrLi) were sold for use In other
Federally-sponsored programs from 1954 to
the late 1960'3. These Included eradication
programs for Japanese beetle, European
chafer, white fringed beetle, and Imported
Fire Ants. Beginning In the late 1950's,
FEDERAL »EGISTSR, VOL 39, NO. 203—FRIDAY. OCTOBER 18, 1974
-------
46
NOTICES
Irln became the compound of choice for
>t these programs, but some aldrtn was
—jttnued (or the Japanese beetle programs.
(c) Other early uses which accounted for
substantial quantities of aldiln. and later
were determined to lead to high residue In
.'oods and their by-products, sometimes used
as •vnirnAi feeds, were soil applications on
land planted to potatoes, peanuts and sugar
beets. In 1354, these uses accounted for ap-
proximately 13 percent of the total used. The
total pounds used annually remained fairly
constant at approximately one-half million
pounds through 1082. Soil use on potatoes
and peanuts wsi withdrawn In 1983 but use
on sugar beets continued until 1987.
(d) Until l.tjS. cotton was the principal
use crop for aldrln. Corn soil usage took the
lead that year ana has been the main single
use since.. A3 of 1071. the estimates showed
that corn soli usage accounted for 80 percent
of the total sales for this product. .Other end
uses, and their percent of the total were as
tollows: Termite and PCO. 14 percent; rice
seed treatment, 3 percent: citrus soil use. 1
percent; other small grains, corn and vegeta-
ble seed treatments, 1 percent; and miscel-
laneous soil applications Including on tobac-
co, vegetables. strawberrlM, 1 percent. Some
of the principal end uses of aldrln for 1954.
1S«4. 1968 and 1971 were as follows:
AU>»D» Esi> TJas ESTUIATU—ItXO Las.
1954 I9W 1983 1971
Cotton (foliage) 834 10
Com (soil) SCH 10.191 12.0S) 9.410
Orasihoppen 476 ?0
Potatoes (sell) 239
Peanuts SI I.
Citrus (soil); JS ICO Jio
•v b«tj 60
treat (eicept rice) 8 SO 110 130
3«d treatment 233 472 2S3
^n«5« beetle 13 .,„.. ...
WMle-rringeu beetle 10 ,
The end use estimate of aldrln under com
Is 8.8. 6.9 and 7.6 million pounds during
1972. 1973 ond 1974. respectively.
(e) A-contlnued gradual decline In aldrtn
sales In the future may occur as corn root-
worm resistance moves eastward through
Indiana and Ohio. Also seed corn maggot re-
sistance to aldrln may also spread outside
tho lowa-niraols area Into other corn-pro-
ducing states.
8. (a)' Dleldrtn was first used as a spray
or dust on cotton for boll weevil control. Be-
cause of Its effectiveness against all cotton
pests except the- lepldopterous species, It was
widely used In Texas and the Mississippi
Delta area. Dleldrln reo.ulred fewer appli-
cations because of Its residual effectiveness
and was applied every seven to ten days as
tho Infestations warranted. Practically all of
the 1051 Kales of dleldrln were for use on
cotton. This use peaked In 1955 when slightly
more than one million-pounds were sold for
cotton Insect control. The boll weevil became
resistant to all chlorinated Insecticides In
tbe late 1950's, and only minor quantities
were sold In the 1980's.
(b) Forage crop uses, particularly for al-
falfa weevil control when this Insect moved
Into tho northeastern United States, ac-
counted for approximately one million acres
being treated annually during the mid to
late 195O's and early 1960's. Armyrrorm. which
attach sporadically, accounted foi1 several
million acres of small grains being treited,
la tie iildwest In the early 1980's. Dleldrln
as well as aldrln was used In tie Federal
grasshopper control programs until the mld-
1900's. Other forage crop pests of lesser Im-
portance which were controlled, by foliage ap-
plications of dleldrln were chinch bugs and
grasshoppers attacking corn and small grains
and the pale Western cutworm, which at-
tacked small grains In the Rocky Mountain
states area.
(c) Dleldrln was also very effective against
houseflles and mosquitoes until these pesta
became resistant. It was also effective against
deer flies, sand flies, black flies and many
other public health pests which were Injuri-
ous and annoying to man and animals. Dur-
ing tha 1950's and Into the 1960's. dleldrln
was used both by Individuals as veil as s-late
and local agencies to control these pests.
Theso uses led to high residues of dleldrln.
In some aquatic environments.
(d) Late la the 1950's. It was found that
dleldrln was a very effective material to
pennaatntly mothproof woolen seeds, par-
ticularly carpets. If used In the hot acid dye
bath, dleldrtn would be taken Into the wool
fiber and "locked", mto the nber. Alter regis-
tration was granted, many of the woolen mills
In the United States started using dleldrln.
Approximately 250 thousand pounds of dlel-
drln were used annually until Shell Chemical
Company withdrew the registration In 1970
when It was determined that some dleldrtn
would remain In the dye bath effluent which
wus discharged Into streams and rivers.
(e) As wtth aldrln, government-sponsored
«• adlcatlon programs for Japanese beetle.
^hlte-frlnged beetle. Euroc"»n chafer. Im-
ported flre ants and alfalfa snout beet;?, too*
constdemb'.e quantities of dleldrtn from tbe
mld-1950's through the late 19SCT3. Probably
the blggrst program was for whlte-f ringed
beetle where usage has averaged more than
10O thousand pounds annually since 1955.
(f ) The overall use of dleldrln has dropped
from a peak of 3.8 million pounds la 1958 to
approximately 600 thousand pounds today.
As of 1971. the end use sales estimates showed
the following percent of the total sales for
the following uses: Termites and PCO, 44 per-
cent; fruit (foliage). 2O percent; seed treat-
ment. 14 percent: vegetables. 13 percent; and
miscellaneous uses Including on to"bacco.
sweet potatoes, etc.. 9 percent. Sales volumes
for 1954. 1964. 1968 and 1971 for- some of the
principal end uses at that point In time
were as follows:
END USE
Las
Tear
Tor
1MO."
19.M. ;
J3J3
1953
1354 —
lass •
IWfl
1657
1S53
1150 _
1WO
1961
I9S2 _ : . '
1W3 _
1964
19M
1063.
1967
1563
1J69
1070
im
1972. ... .. '.
n73(toJoJy l)
1973 estimated (to Dec. 3D .
1973 ^
1974 (la Juty 1).
Aldrta
O.ooo Ito)
1,45*
J.2SS
814
1.234
2.W3
4,372
8.4»
2.431
4.971
S.SM
8.100
9.9M
10.SS4
12.152
12.603
14.778
19,377
13.092
1X400
9,902
8. COO
11.615
11. US
8,721
00.000)
9.900
9,700
Dlrldrin
(1 ,000 Its)
0
IM
710
1.134
1.777
2.SSS
3.6M
2.S73
3.074
' 3.008
2.SM
2.764
' 2.310
2.6S5
2.0S2
1.314
1,503
1.473
1.132
1.208
749
704
110
433
(57iJ)
_
1944 1944 IW3 1971
Cotton (follsse} 757 ' 20 1_
Public heoith 92 "...
Government programs.. 133 205""l04
Fruit (fotlase) (plum corcalfo).. 202 4CS 317 "126
Mothproofuip • ; 820 153
Sranll prafiu (foliage) 175' ISO I
Email Package (borne and gar- "
don oa>) : 277 M 2
9. The domestic sales of aldrln and dleldrln
from 1950 through July 1, 1974. Including
consumer/specialty sales but excluding ealea
to the World Health Organization and tiie
Agency for International Development are
as follows:
10. The_Aldrln/Dleldrln Advisory Commit-
tee appointed by the Administrator Issued a
report March 23, 1972, which'contained'the
following conclusions and recommendations:-
Conclusions. We find evidence of human
Injury from present or past use of aldrln or
dleldrln. Nevertheless the'facts that fairly.
low levels of dleldrln can cause cancer In
mica and Interfere with . reproduction In
some blrds'are matters for concern, and point
to the need for more careful evaluation of the
hazard to man There Is clear evidence that
past usages have been deleterious to wild-
life. Several such.past usages have been vol-
untarily abandoned by Shell Co. Nevertheless.
we feel that we must strive to find alternate
methods of pest control. Including nonchem-
Icnl methods, for all compounds which lead
to persistent residues In humans or wildlife,
even when such residues are not demxrastrn-
bly harmful. How can we move towards this
objective. When aldrln or dleldrln can be
safely and economically replaced by nonper-
slstent pesticides they should be so replaced.
Several practices which can readily lead to
damaging effects upon non-target organisms
should be abandoned now In spite of the dif-
ficulty of economic replacement, Including
all applications which lead to contamination
of aqueous environments such as rice fields
and waterways.
• The direct application of aldrln or dleldrln
to soils leads to negligible teaching or other
transfer from, these solla, and environmental
contamination Is thus very small except
where substantial erosion takes place. One
of the few studies to estimate the amount
•which volatilized Indicates that 3 percent
escapes this way. and thus contaminates the
environment directly (we would like to see
more extensive data upon this point).
Rfcommerula.tiorra. The following recom-
mendations are designed to build a basts
of facts on which permanent recommencrtt-
tlons can be formulated, and to eliminate
now those uses of aldrln or dleliSrtn which
result In slgnlflcAnt envtrorowntaj contam-
ination (especially to water*-./i). We believe
that applications directly, to \MU or to ma-
terials burted In sou (e.g. ttrmlto control
In foundations, and seed b«\.fcnents when
properly applied) lead to little subsequent
movement of these Insectlclc^fia, and should
be permitted.
FEDExAl RECISm, VOC 39, NO. 203 RUDAY. OCTOBEJ 18, 1774
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47
NOTICES
In the following recommendations, we use
the term "experts" and "acknowledged au-
thorities" advisedly. The EPA must seek
contractual or other arrangements with In-
dividuals and Institutions accepted as au-
thorities by their peers In the country at
large.
1. A committee of experts In chemical
cardnogenesIs should be formed to propose
specific experiments and to agree upon suit-
able protocols to provide a arm Indication
of the extent of carcinogenic hazard. These
experiments should Include studies (In at
least two vertebrate species) on the effects on
the progeny of mothers fed dleldrln during
pregnancy and nursing, the progeny also
being fed dleldrln thereafter.
2. The economic consequences of total
withdrawal of aldrln and dleldrln should be
explored In depth: On all major crops, ac-
tual experimental studies must be performed
to.obtain new, reliable data provided by ac-
knowledged authorities, and should Include
studies with and without alternative non-
persistent pesticides, over a series, of years,
and In appropriately distributed geographical
areas.
3. The fraction of aldrln and dleldrln which
escapee by volatilization following applica-
tion to a variety of soils, under conditions of
application and treatment levels commonly
used In pest control, should be measured by
acknowledged authorities.
4. Monitoring stations should be estab-
lished In the U.S. and abroad, at which air
and water samples can bo taken at fixed
places over a series of years, and analyzed by
unambiguous procedures for oldrtn and dlel-
drln. The Intent Is to study whether the
restrictions we propose do Indeed lead to a
progressive removal of these compounds from
the environment. Agreement should also be
•ought amongst a group of experts for un-
mblguous procedures for determination of
Jdrtn and dleldrln In extracts of air. soil.
water, food and human and nonhuman tis-
sues. Such procedures should be standardized
In the U.S. and preferably Internationally as
well.
5. The following uses of aldrln or dleldrln
should be disallowed.
(a) All applications by aircraft. .
(b) All foliar spraying or dusting.
(c) Moth proofing by the hot acid dye bath
method or related methods In which residues
are discharged Into waterways or settling
ponds.
(d) All uses, whether by homeowners or
pest-control operators. In homes, barns, poul-
try operations or other structures occupied
by humans or livestock.
(e) Use upon turf (Including lawns and
non-grazing grassed areas) except as super-
vised or controlled by trained or licensed
pest-control operators, greeaskeepers and
nurserymen.
(f) Any use which Involves application to
streams, ponds, lakes, flooded areas or any
other aquatic environments.
6. Specific uses of aldrln and dleldrln which
we believe to be valuable and not harmful
Include:
(a) Direct applications to soils.
(b) Seed treatments, when the treated
seed la labelled "not for food use".
(c) Dipping of plant roots or tops during
transplantation.
(d) Treatment of foundations, by current
procedures, for termite control.
(e) Use of treated hot-caps.
7. Because our recommendations are based
upon evidence which, although the best
available. Is still not complete; we recommend
that the environmental.and economic effects
of the proposed restrictions be reviewed 5
years after their Imposition. By that time.
he completed results of recommendations
, 2, 3 and 4 should be available.
11. Cancer Is a major and Increasing cause
of death and morbidity la man. It Imposes
upon society on Immense burden of death,
suffering, and economic loss.
12. Chemical carclnogensls has two key
characteristics, Lrreverslblltty of effect, and
long latent period between Initial exposure
and manifestation of symptoms. In principle.
no dose or a chemical carcinogen Is too small
to Induce cancer In susceptible Individuals.
Some cancers do not develop until late In
life—in man. usually 20 and sometimes 30 or
40 years after Initial exposure.
13. Chemicals known to cause cancer In
man have been Identified only through
epldemlologlcal studies, either In the general
public, or la occupatlonally exposed workers.
In the case of aldrln/dleldrtn, epldemlologl-
cal studies in the general population are not
possible because there are no clearcut dif-
ferentials of exposure and because the period
of exposure has been too short. A study of
occupattonally exposed workers, carried out
by the Shell group of companies, is of no
value, from an epldemlologlcal standpoint, as
a carclnogenlclty study because the number
of workers studied was too small, the period
of observation was too short and only active
male workers were studied. As with most
chemicals. It Is therefore necessary to rely
on experiments with animals to determine
the- potential carcinogenic hazard of aldrln/
dleldrln to man.
14. The use of experiments with animals to
screen chemicals for potential carcinogenic
hazard to man Is accepted by the scientific
community and by public policy-making
agencies In the United States. Chemical cor-
clnogenesls In animals provides a very close
parallel to chemical carclnogenesls In. man.
All chemicals known to cause cancer In man
except arsenic which Is under study also
cause cancer in animals, especially rats and
mice. The pathological development of
chemically Induced tumors In animals and
In man Is very similar. However, human
populations are more variable than the
strains of animals usually used In laboratory
teats, and some Individuals are likely to be
correspondingly more susceptible.
15. Chemical carclnogenesls Is a specific
biological process which Is Induced by only
a relatively few classes of chemicals. It Is
not true that all chemicals induce cancer
at sufficiently high doses. Most, probably all,
chemical carcinogens that have been ade-
quately tested cause cancer in more than one
species of animal. It Is not true that there
are "species-specific" carcinogens. Also. It Is
not true that there are "strain-specific" car-
cinogens, but some strains of mice are espe-
cially susceptible to Induction of certain
kinds of tumor.
16. Transplantabillty of tumors and/or
metastaslzing to other organs provide proof
that chemically Induced tumors are "malig-
nant"; however, all chemical tumorigens
should be regarded as potential carcinogens.
17. Guidelines for conducting acceptable
experiments on chemical carclnogenests In
animals have been recommended by expert
professional committees. The mouse and the
rat are the preferred experimental animal
species, both because their relatively short
llfespan permits lifetime testing within a
reasonable period of time, and because the
pathological development of tumors In these
species Is particularly well known and under-
stood.
18. A number of adequately conducted ex-
periments have shown conclusively that
aldrln and/or dleldrln Induced cancer In 5
different strains of mice, and. perhaps, In the
rat.
19. Reported carclnogenlcity test3 with
aldrin and dleldrln In dogs and monkeys
were carried out for too short a period to
draw any definite conclusions, but pre-con-
cerous lesions were observed In the Uvers of
the dogs. No adequately conducted carclno-
genlclty test with aldrln or dleldrln In any
species of animal has given negative results.
20. In the experiments with mice, aldrin
and dleldrln induced cancer primarily In the
liver, but In some experiments significant
incidence of cancers of the lung and other
organs was reported.
21. Tumors produced by aldrln and diel-
drln in mice have been diagnosed by expert
pathologlsts as unequivocally malignant. In
some experiments tumors metastaslzed to
other organs, or were successfully trans-
planted to other hosts, providing further
proof of malignancy. In at least some experi-
ments, malignant tumors produced by aldrln
and dleldrln significantly shortened the life-
span of the experimental animals. In the
moot extensive series of experiments, carried
out by Shell research scientists, the Inci-
dence of liver and other tumors In mice was
clearly dose-related. A significant Increase
In the Incidence of liver and other tumors
was observed at the lowest dose tested, 0.1
ppm In the diet.
22. Even a limited exposure to aldrln/
dleldrln for only a few weeks early In life
led to a significant increase In liver tumors
In mice, despite cessation of exposure.
23. None of the reported experiments In-
volved exposure of the experimental animals
to aldrln/dleldrin prior to weaning, although
younger animals and fetuses in utero are
likely to be more susceptible to these agents.
24. Dleldrln Induces enzymes In the liver
which may activate certain environmental
carcinogens. A threshold level of dietary
dleldrln for Induction of these enzymes In
man Is not known.
25. There Is no scientific basis for the exist-
ence of a "threshold" or "no-effect" level of
exposure of an animal population to a chem-
ical carcinogen. It Is impossible to establish
a "safe" level of exposure of aldrln/dleldrin
to man.
28. Aldrin/Dieldrln have been found to be
carcinogens In the mouse as a result of ade-
quately conducted testa In laboratory con-
ditions. They pose a carcinogenic hazard to
man.
27. Many kinds of Insects spend "at least
part of their lives In the soil. Of the thou-
sands of Insects in or on our soils, only 20
or so are classed as pests of corn. Except
for a few species, they are general throughout
the corn-growing areas of the United States.
While most of the impotrant soil Insect pests
are found over broad areas, usually only one
or a few at a time are of significant eco-
nomic Importance In an Individual field.
The area, population dynamics, weather, soil
type, crop rotation and general agronomic
practices will Influence the buildup of In-
dividual destructive species.
28. A common characteristic of all soil In.
sects Is their four-stage life cycle: (I) Egg,
(2) larvae (worm or group), (3) pupae (rest-
Ing stage) and (4) adult (beetle, moth or
fly). Eggs are laid by the adult female In
areas suitable to that species. Northern corn
rootworm female beetles will lay their eggs
In cornfields. Female "click" beetles (adult
wlreworms) usually seek out grassy areas
so the young larvae will hove sufficient food.
However, In Iowa an annual species has been
. reported to lay eggs in only the bare spots In
Qelds. Where eggs are laid plays an Im-
portant role in what Insects will be present In
the spring corn crop as farmers csn plant
corn following many crops or sods. Eggs
hatch Into larvae which are commonly called
grubs, worms or maggots. With the group
called soil Insects, this Is the stage rhat usu-
ally causes the most damage except for most
notably the seed-corn beetle. Most of the
larvae, with the exception of the Northern
FEDERAL REGISTER, VOL 39, NO. 203 FRIDAY, OCTOBE* 18, 1974
-------
48
NOTICES
and Western corn rootworms, have food pref-
r *es other than. com. Most are general
n and when their main food supply Is
removed they readily adapt to corn. As larvae
mature they enter the pupal stage of growth.
Ic'3 hero they complete the change from lar-
rae to adult beetles, or moths or flies. A few
fit the adult soil Insects are also destructive.
119. .The corn, soil Insects which presently
can. or do cause Injury of economic signifi-
cance are as follows:
(a) Wtreuorna: Uelanotua ap.. Conoderua
jp. and Hori3tone>tU3 yp. and other species
of Wi« family Elaterldae. Wlreworms species
attacking corn may differ some In specific
areas but In i.-neral they all cause similar
damage to seed arid young plants. Afelanotua
ap. are most common throughout corn areas
and pose the most problems for com growers.
Most of th« damaging wlreworm species have
a life cycle from egg to adult of 2-4 years. The
life span appears to be longer (4-fl years) In
colder climates and shorter (2-3 years) In
southern areas. The Conaderta ap. is an an-
nual wlreworm laying eggs In grain stubble
which has not been second cropped. These
wlrewonns are most prevalent in the south-
eastern United States but are becoming more
of a problem In the central Corn Belt. Adult
wiraworms (click beetles)1 show a preference
for sod anas and eggs may be laid In pas-
tures, grain stubble, hay fields, weedy row
crops acd other grassy areas. When sod or
other grassy areas, are tilled for corn the
next spring, the worms feed on the corn seed
and young corn plants aa their other food
diminishes with the elimination of weeds
and grass. Because eggs are laid each year In
grassy fields, wlreworms with more than a
one-year cycle may b» present In any stage.
When populations ore heavy they may com-
pletely destroy not only the original plant-
Ing but subsequent replantlngs. Wlrewonns
like and need moist soil "id wm tend to
•* the moisture table In the ground. In
t spring they will be more of a problem
than In a dry pne. Wlrewonns will tunnel
Into newly planted seed and kill the ger-
mination. They will also bore Into the base
of young com plants below ground killing
the growing point In the corn plant. The
r.ewly-emerged plant starts to wilt and die
from the -center out and finally the entire
plant dies or produces suckers which bear
no ears. In large numbers, entire fields can
be lost. Planter box treatments and row
treatments of alfirln are not aa effective aa
broadcast applications and may not provide
adequate control under population stress.
(b) Cutworms. Black* cutworm, Agrotia
ypiilon (Rottenburg); Glassy cutworm. Cyr-
modea devastator (Brace); Bronzed cutworm.
Nephilodei emmedontiu (Crawer); Dingy
cutworm, Feltid subgottiica (Haworth);
Brlstley cutworm. Lactnyolia renlgera (Ste-
phens) ; Clay-backed cutworm Agrotia gladl-
aria (Morrison): Sandhill cutworm. £uroa
deteroa (Walker). The black cutworm Is by
far the most widely found and the most
damaging. Most of the problem species are
surface feeders except for the glassy cutworm
which Is a true subterranean cutworm. Cut-
worms will generally feed on the newly-
sprouted plants. Moisture In the soil and at-
mosphere conditions help to control the feed-
Ing pattern. When the soil Is moist or wet and
nights are cool with high humidity, the cut-
worms win feed on the surface cutting off
the corn plants. As the soil dries the cut-
worms may not surface, feeding only below
ground, living In the moist soil. Much of the
life cycle and biological history of the cut-
worms Is still unknown. However, In general,
they tend to overwinter as nearly full-grown
larvae. Adult moths tend to lay eggs In grassy,
wet areas. Black cutworms not only over-
•"•'-ter as larvae but migrate Into the Corn
Belt area from the south In March and April.
Cutworm damage Is generally associated with
poorly drained river bottom land, heavy soils
and low wet spots In upland field*. It Is also
more extensively found In first year corn fol-
lowing aod or legumes. Failure to notice a
cutworm problem early may result In a lost
field or part of a field that must be replanted.
(c) WMte gruoa: ^fiyUophcga or Haehnoa-
tenna app. These are the most common grub
pests.'They are the larval form of the com-
mon May and June beetles. The beetles prefer
grassy areas such as pastures, soil bank land
and hay fields. These differ from •"""•*'
grubs by having life cycles that take 2-4 years
to complete. Three-year cycles are most com-
mon. White grubs appear most often In cam-
fields whea. sod ground or grassy areas are
spring plowed. With their 2-4 year life cycle.
they con pose a problem to the farmer more
than one year. However, the most destructive
damage occurs the first year after sod. Dam-
age comes In the form of plants wilting and
"drying up." The larvae prune the roots and
the plant literally dies of thirst.
(d) Corn Rootworma. Northern Corn Root-
worm. Diabrottcd longicomia (Say); Western
Com Rootworm. Diabrotica virgifera (La
Conte); Southern Corn Rootworm, ZHabrotica
undecimpunctate howordi (Barber). The
Northern corn rootworm Inhabits the en-
tire Corn Belt while the Western can be
found In damaging numbers In Colorado.
Nebraska, Kansas, South Dakota, Minnesota!
Iowa. Missouri, Illinois, Indiana, and Wiscon-
sin. The first Western beetles were found In
Tnrtlftrm In 1071. Southern corn rootworma
migrate north each year and ore usually
more of a problem In the southern area of
the Corn Belt or In southern corn-producing
areas. Northern and Western corn rootworm
adults lay their eggs In cornfields during
August and September. The eggs overwinter
and hatch the following spring In late May
and June. If com is present they feed and
survive. The life cycle Is broken by rotation
as Northern and Western rootworma need
com to survive. Southern corn rootworms.
on the other hand, overwinter In southern
areas and fly north each year, laying eggs In
the spring In planted cornfields. In some of
the southern corn-producing areas, two gen-
erations a year may occur. After hatching,
the larval form of the loutworm begins feed-
Ing and tunneling into roots. In severe cases
corn may wilt and die from root pruning.
Usually, however, the root pruning results in
weakened stalks that are subject to lodging
and yield reduction. Western, and. Northern
com rootworms are generally .resistant to
chlorinated hydrocarbons.
30. The Influence of previous crops on the
prevalence of sell insects In corn Is as follows:
Underground corn tas*c<3
Other major factor
Tear following meadow
1st
2d
3d
4U)
4th
Elreworms .,........— -......,.«
Sod webworms (5 species)
• White gnibg (2-3 species) „
Southern corn rootworm
Northern and western corn rootworm..
Boll TPOlstnn........
.
XX
XX
XX
X
*v
XX
x
x
X x
x
x
x
x
u
x
— XX
x
x
XXX
..
XXX
31. Registered and effective alternatives to
Aldrtn for control of rootworms In corn are
Furadan. Thlmat, Dasanlt. Dyfonate, Dlozl-
non and Mocap. Counter has a temporary
use permit and Is expected to b» registered
for rootworms and wtreworms before the
1978 crop year. Dow Chemical Company Is
presently seeking registration of Dursban.
Insecticides which control resistant root-
worm will also control nonreslstant root-
worm.
32. Dlazlnon is registered as a preplant
control method for the cutworm and an
application Is pending for Furadan. Reg-
istered and effective insecticides for post
emergent treatment are Carbary] and Dylox
baits or sprays and toxaphene sprays.
33. Registered and effective alternates to
Aldrtn for control of wlreworms In corn are
Dasanlt, Dlazlnon, Dyfonate and Furadan.
An application Is pending for registration of
Mocap. Thlmet Is labeled for reduction of
wlreworms.
34. No significant macroeconomtc or
mlcroeconomlc consequences will result
from the suspension of aldrin for use- on
com In 1975.
35. The Fuller Rose Beetle was recognized'
as a pest of Florida citrus In 1952 when
large numbers were observed in several
groves In Indian River antf St. Lucle Coun-
ties. Since that time, this pest has been col-
lected from 30 counties In the state. Its life
cycle adheres to the 4-stage pattern Inherent
In beetles consisting of the egg. larvae, pupa.-
and adult. Eggs are deposited above ground,
the hatchllng larvae drop to the ground and
enter the soil to feed for 10-11 months, a;
they mature, on roots. Pupation occurs in
the soil and adults emerge from the soil to
remain above ground feeding on the foliage.
mating, and laying eggs. It Is presently con-
sidered unlvoltlne, producing but one^gen-
eration per year. The adults feed on the
young leaves of citrus and when in great
numbers, cause serious setback of young
plants. Adults also feed on- the flowers and
on rind of young fruit, resulting In unsight-
ly peel scars when the fruit matures. Oc-
casionally, young shoots may be devoured.
The most serious Injury by the pest is pro- •
duced by the larvae which destroy the plant
roots.
38. Affected trees have sparse foliage that
may become chlorotlc and wilt. When larvae
are numerous, young plants may be killed In
a short time- or dwarfed. Older trees ore
more resistant, but do not grow well, are
unthrifty In appearance, become poor
yielders, and occasionally die. Since the
damage caused by the larvae takes place
underground. It often remains unnoticed
until the plants start to wither and 'die
back'.
37. Although the Fuller Rose' Beetle has
been collected from 30 counties In Florida,
Its economic significance is very circum-
scribed geographically. Of the 877,000 acres
of citrus In Florida, the rose beetle !s only
present In numbers sufficient to commence
to reduce yield on between 1.3,000 and 50,000
acres. The area of significant Infestation is
essentially the Indian River area- of the
Southeastern seaboard of Florida, an area
characterized by poor>lnferaal soil drainage,
'a high water table, and consequently un-
usually shallow citrus root systems. A 1955
s.udy indicated that In a typical In'Jkm
River grove, 75 percent of the feeder roots
of citrus trees were located within 18 Inches
FEDERAL RSGISTER, VOl. 39, NO. 203—FRIDAY, OCTOBER 18, 1974
-------
49
of tie top of th« rldga of sod upon which
citrus trees are usually planted in tiiat area.
CUrua tisea Tont ertand their roots Into
waterlogged soils. The result la trees distin-
guishable by particularly restricted roo* sys-
tems with unusually limited supplied of
feeder roots. These systems axe less able to
make do with decreases In root productivity
resultant from Insect damage which would
be Insignificant in other regions within the
state.
38. Less than 3 percent of the total citrus
acreage In Florida has ever been treated with
any soil Insecticide for control of any insect,
and even within the Indian River Fuller Rore
Beetle trouble region only 20 percent of the
acreage has been so treated. The Puller Rose
Beetle Is one of the -more minor citrus pests
In Florida. However. In some cases, the Fuller
Rose Beetle'is present In an area In such
numbers that citrus yields are substantially
reduced. In most of those Instances, 21/,
pound per acre treatments of aldrln twice
during a' growing season will provide ade-
quate pest control. Citrus yields are reported
to have markedly increased after Insect dam-
age and such treatment.
39. The theory behind aldrtn/dleldrtn soil
treatment for citrus beetle control la that
the chemicals should be Incorporated In the
surface of the soil surrounding citrus, creat-
ing a toxic barrier. Beetles may be killed dur-
ing two stages of their development, when
as larvae they drop from aerial regions of
vegetation and enter the soil to feed, and
when its adults they emerge from the soil
to remain above ground, feeding, mating,
and laying eggs. In a series of threshold tests
In 1957 and 1958. aldrln provided approxi-
mately 78 percent control of rose beetles.
40. Aldrln/Dleldrln Is overused on citrus
to some extent, In the sense that It Is un-
necessarily utilized. Citrus growers can tol-
erate some crop loss before pesticide appli-
cation Is economically Justified, yet before
application of these chemicals they generally
do not consciously formulate economic
thresholds for determining when aldrln/
dleldrin pays for Itself In terms of Insect con-
trol. In some Instances, and particularly In
the case of nurseries, these chemicals are
employed as preventatlves or Insurance be-
fore Insect damage Is discerned. Many
growers attempt to eradicate Insect pests
through applications of aldrtn/dleldrtn
rather than reducing them to Insignificant
levels. In certain Instances, however, the
rose beetle substantially reduces crop yields
absent the use of aldrln/dleldrln and with-
out alternative means of control. In terms of
the entire Florida citrus Industry these In-
stances are relatively rare.
41. The Coca-Cola Company, as one of
Florida's largest citrus growers, does not use
aldrtn/dleldrtn. receives fruit from groves
located In areas where root weevil Infesta-
tions occur, yet carries on profitable opera-
tions. The Company's decision not to utilize
these chemicals was s-ubstantlally the result
of worker pressure resulting from, possible
health and safety problems Involved In their
use.
42. In view of the life cycle pattern of
the rose beetle, whereby these insects gen-
erally mature from a larvae stage In the soil
Into adult weevils and then climb up weeds
or citrus trunks or branches to lay their eggs.
there Is a large potential for disruption of
the pest problems through cultural methods.
If weeds and low-hanging citrus branches
are cut down, major routes of access to the
egg-laying areas of citrus will be closed off
to the weevils. Particularly in California, cer-
tain sticky bands have been placed around
trunka and have been effective In reducing
the alternate path of weevil ascent. If the
NOTICES
adult Insects can efTectlvely be denied such
ascent, their dataage to the aerial regions of
Cltrua trees can be minimized and the In-
secta procreatlve habits and efficiency can be
stunted. Such means of pest control have
not been extensively pursued In Florida.
43. California does not recommend the use
of aldrln/dleldrta for control of the Fuller
Rose Beetle on Its very substantial citrus
acreage although such Insect also constitutes
a pest of citrus In that state. Instead, the
California spray program recommends mala-
thlon for concrol of the Fuller Rose Beetle.
and both se"ln and parathion to help with
that beetle and to control certain other lu-
sect pests of citrus. Even within Florida,
parathion and fzuthion. registered alterna-
tives, are recommended as pirt of that state's
spray and dust program. Various foliar
sprays, most of which are already used In the
Florida citrus program, some as often as 4
to 8 times a year, provide good Initial kill
of the adult weevil at Issue. Included among
these are malathlon, furadan. sevin, guthlon,
orthene, lannate. supraclde, and phosphaml-
don.
44. Suspension of the use of aldrin/dlel-
drln on citrus would not result In detrimen-
tal macroecoaomlc consequences. The need
for treatment of the Fuller Rose Beetle Is
very confined, cultural and Insecticldal al-
ternatives are available and any adverse con-
sequences will very easily become translated
into a relatively minor shift In the supply-
demand equilibrium. Nor are substantial mt-
croeconomic consequences anticipated.
45. No significant macroeconomlc or micro-
economic consequences will result from the
suspension of aldrln or dleldrln until com-
pletion of the cancellation proceedings for
all uses Involved In these suspension pro-
ceedings In addition to corn and citrus.
CONCLUSIONS
I. Carcinogenic activity of a chemical can
be detected by observation In man and by
bloassay in experimental animals. The con-
clusive detection of the carcinogenic effect of
a chemical by direct observation In man Is
extremely difficult. It may take 20. 30 or more
years for a population to respond to a new
chemical exposure with a significant Increase
of cancer cases due to the long latent period
Involved, that Is. the time between exposure
to a carcinogen and the manifestation of the
effect, namely the tumor. In addition, the
frequency of cancer In the population Is very
high, so that In order to demonstrate the ex-
istence of an Increased risk related to a given
exposure one needs a well-denned large popu-
lation with known history of exposure and
another comparable control population with-
out that exposure. In the case of materials
that become contaminants of the rvhole
population, such as dleldrln.' this approach
is almost Impossible or nonappllcable.
Consequently, in the case of a food con-
taminant such as dleldrln where the Identi-
fication of a non-exposed control popula-
tion is difficult or Impossible, the chances of
detecting a carcinogenic effect by observa-
• Surveys conducted by the Food and Drug
Administration show that dleldrln Is found
In as much as 96 percent of all meat. ash. and
poultry "composite samples" tested, and 85
percent of all dairy product "composite sam-
ples" tested. In addition, EPA surveys in-
dicate that dleldrln Is In approximately 90
percent of all air samples taken nationally
and residues of dleldrtn have been found in
virtually ail of the humans Included In the
EPA human monitoring survey. While the
FDA surveillance program found less dieldxta
present than in its mart-.et survey, the
amounts found were still significant.
ttous iu man ire extremely remote." The
human epidemlologlc study by the She!1.
group of companies involving workers at the
Pernis. Holland Plant: is admitted by the
Shell Chemical Company not to be an ade-
quate epidemiologies! study for cancer and
was clearly so described by expert epidemiol-
ogists In these proceedings. In short, this
study only examined a very small number o.'
Individuals for a period of time tot.illy in-
adequate to assess a change in cancer rlsl:
extending over most of a lifetime.
For all practical purposes, the detection
of carcinogenic activity of new chemicals is
based on animal experimentation. All chemi-
cal substances or mixtures that have been
proven carcinogenic by direct observation in
man have also been shown to be carcinogenic
In experimental animals with the exception
of arsenic which Is still under experimental
study. Because of the difficulties of epldemi-
•ologlcal studies on human carcinogenic ex-
posures, there are usually no data which
provide us with any evidence on whether
cancer in man is caused by a chemical that
has been shown to be carcinogenic in other
mammalian species.
Bloassays are always performed on a num-
ber of animals which is extremely small when
compared with the millions of humans ex-
posed to most environmental carcinogens.
Such studies can only detect carcinogenic
effects resulting in fairly high Incidences and
the number of animals used In the tests Is
the main limiting factor of the sensitivity of
the test system. The sensitivity of currently
used animal bloassay systems Is In most
Instances very limited. Therefore, any chemi-
cal which is detected as carcinogenic by such
rather Insensitive test systems represents a
warning signal of great significance.' In fact.
while It Is customary or required that more
than one species of laboratory animal be
tested for carclnogenlctty, a positive, con-
firmed finding as to one species Is of extreme
and grave importance.' This Is reflected In
the Delaney Clause or Amendment to the
Federal Food, Drug, and Cosmetic Act (21
U3.C. 348(c) (3) (A) ) which provides that no
food additive "shall be deemed to be safe
If It is found to Induce cancer when Ingested
by man or animal" and which "Is generally
Intended to prohibit the use of any additives
which under any conditions Induce Cancer In
any strain of test animal." "Bell v Ooddard "
366 F.2d 177, 181 (7th Clr. 1966). Conversely.
negative findings In carclnogeniclty tests are
of little significance In view of the Insensitlv-
Ity of the system.
II. Carcinogens are chemical, physical or
biological agents, exposure to which, of
•The detection of the great cancer "epi-
demic" caused by cigarette smoking was made
possible by the existence of a non-exposed
population living in otherwise comparable
conditions with those exposed. Also, besides
the comparison of smokers and non-smokers.
a quantitative estimate of the amount of
cigarettes smoked make It possible to Iden-
tify groups of population at different risks
1 Jager. Aldrln. Dieldrln. Endrin. and Telo-
drin: An Epldemiological and Toxlcologlcwl
Study of Long-Term Occupational Exposure
(1970).
• It should be stated at this point, perhaps,
that a relatively small number of chemicals,
700-800 or a maximum of 1.000, have proven
to be carcinogenic in laboratory animals. It Is
not true that all or most substances can cause
car.cer In laboratory animals depending upon
the dose applied.
•This Is so. In part, due to the nature of
cancer, that is. Its irreverslbillty and long
latency period following the Initial exposure
to the carcinogenic agent.
FEDERAL. REGISTER, VOL 39, NO. 203—FRIDAY. OCTOBER 18, 1974
-------
nals or humans. Increases the probability
.nductkm of tumors or neoplaslo. This may
be manifested by an Increase in the number
of individuals developing the tumor, an In-
crease In.the number of tumors In.each in-
dividual, a decrease-In'the age at which the
tumors appear, that Is. reduction In the
Intent period of tumor Induction, any com-
bination of the above effects and perhaps the
appearance of unique or unusual tumors.
It Is patent, it seems to us, that on the
basis of our current knowledge or "conven-
tional wisdom" the'evidence Is overwhelming
that aldrln ant. dleldrln are carcinogens in
the mouse." '. ..is is established by the testi-
mony of extreinely welt qualified and renown
experts la the field of corclnogenesls juch as
Drs. Samottl. Heston, Farber, Epstein and
others based on many laboratory tests of the
mouse." in fact, there are probably few pesti-
cides whose carclnogenlclty In mice »s so
thoroughly and conclusively documented.
This was. in effect, the conclusion also of
the International Association for Research in
Cancer which concluded In Volume 5, Mono-
{raph on the Evaluation of Carcinogenic Bisk
3f Chemicals to Man, as follows:
Dleldrln was tested by the oral route only
j» mlc« and rate.' The bepatocarcinogenlclty
it dleldrln in the mouse has been demon'
itrated and confirmed In several experiments.
icct some of the liver cell tumors were found
•-o metastaslze. A dose-response effect has
jeen demonstrated in both sexes with an
• '-ncreased incidence In females at the lowest
lose tested, 0.1 ppm in the diet. (Correspond-
Jig to about 0.015 mg/kg bw/day). In mice
there is no evidence of carclnogenlclty in
organs other than the liver. .
The available date, in rate have not pro-
vided evidence of carclnogenlclty at levels
up. to 60 parts per million in the diet.
rrespondlng to an intake of about 2.3
,,/kg bw/day)..-.:
The experiments in dogs and monkeys were
too limited in duration and/or group sizes to
allow any conclusion to be made.
Further, witnesses for the Shell Chemical
Company admitted at the hearing that the
incidence of liver tumors in 6 different
strains of mice evidenced statistically sig-
nificant Increases resulting from the oral
dietary administration of dleldrln and many
of the tumors in question have been dlog-
»Shell Chemical Company does not and,
in reality, cannot dispute such conclusion.
The position of Shell herein is. Instead, to
the effect, in part, that the mouse is not an
appropriate nnim«] in this connection, a con-
tention we shall consider later In these Con-
clusions. The position of the Shell Chemical
Company has been shifting on the issue of
the mouse liver tumor and Its significance
and is also not in complete agreement with
Its witnesses. This makes it extremely difficult
to prepare a decision in the very short period
of time available, the preparation of which
had to begin, therefore, prior to the filing of
briefs or even the. closing of the record, and
may be prejudicial to the other parties. Con-
sequently, this decision Is responsive to what
we had believed Shell's position to he and
also to what it now Is. We note, for example.
.that in Its brief, Shell carefully avoids the
word "cause" in connection with dleldrln and
tumor incidence contrary to what wis stated
on the record of the hearing as to Its position.
u Wlille aldrln use accounts for nearly 95
percent of the total use of the 2 compounds.
. aldrln breaks down rapidly into its metab-
olite dleldrln. Consequently, residues found
in man and the environment are principally
:drtn residues and thus the hazards of
idrln are of prime significance.
50
NOTICES
nosed as unequivocally malignant.11 ma
mice were of In-bred strains and an out-
bred and hybrid strain. The primary organ
Involved Is the liver, but there was In addi-
tion a significant Increase in tumors In the
lung and other organs In some experiments.
Further, positive dose-relationship In the-
incidence at liver tumors primarily and In
lung and other tumors was manifest. Liver
tumors metastoslzed to other organs within
the M»i>n*i« and were successfully trans-
planted and. In at least some experiments,
dleldrln shortened the latent period for
tumor Induction as well as Increasing the In-
cidence of tumors. Other evidence of dlel-
drln's carclnogenlclty in the mouse Is also
present.1*
The fact that dleldrln increased tumor
incidence in mice of naturally occurring
tumors does not alter our conclusions with
respect to the findings In the mouse or their
significance for man, to be discussed later In
them Conclusions. A3 explained by Or.
Walter EL Heston. Chief of the Laboratory of
Biology of the National Cancer Institute, a
geneticist with 36 years In cancer research In
experimental nnlmals as a basis for the prob-
lem of cancer in man and the "father" of
strains of test animals.
A carcinogen, therefore, should not be de-
nned only as something, that produces
tumors In a strain In which such tumors
never occur without the carcinogen. Such a
strain probably does not exist. A carcinogen
Is a substance that can Increase the prob-
ability that a tumor will arise. It increases
the incidence of a tumor In a strain and usu«
e ay reduces that latent period of the tumor.
IT. testing a substance for carclnogenlclty, the
aim. therefore. Is to ascertain whether it ""»
significantly Increase the Incidence of any
tumor, and the choice of strain for demon-
strating this Is usually not the'most sus-
ceptible, nor the most resistant but one with
an Intermediate genetic susceptibility.
In addition. Dr. Heston further testified that
not all strains of mice or of any other species
have the same Incidence of spontaneous
tumors and that "One cannot therefore state
categorically that the mouse-—La. all strains
of the mouse—present an unacceptably high
Incidence of spontaneous tumors." As empha-
sized by Dr. Heston. well controlled experi-
ments have been run with at least 5 strains
of mice having different Incidences of spon-
taneous liver tumors and it has been demon-
strated from all strains that aldrln and dlel-
drln are carcinogenic In mice. Dr. Heston goes
on to say that "Snowing this, and Knowing
the general biological similarity of mice and '
other mammalian species. Including man, we
can reasonably expect that In a population
of human being exposed to Aldrln/Dleldrln,
cancer of some kind will occur In some Indi-
viduals, and that these Individuals would not
have been afflicted in the absence of these
compounds."
a There Is no valid distinction between the
induction of benign or malignant tumors
in determining the carclnogenicity of a com-
pound and Shell Chemical Company and Its
pathologist witness employed at Tunstall do
not contend that there is although some of
the cancer experts testlf- Ing on behalf of
Shell appear to make such distinction.
°The evidence In these Consolidated sus-
pension proceedings went beyond the evi-
dence available to and the conclusions of the
1AHC quoted above. In addition, our conclu-
sions are not affected by the last minute re-
vised data differing from prior published
studies adduced by the Shell Chemical Com-
pany. Also, time Is lacking for an acalysL:
of each of the mouse experiments Involved
and no useful purpose would be served
thereby.
The testimony and exhibits of the addi-
tional experts In carclnogenesu presented by
respondent and the Environmental-Defense-
Fund, Inc. convincingly support the view that
the-mouse is. indeed, an appropriate test
animal for predictability to man. In short.
most chemical carcinogens that have been
adequately tested in different species show
that they can produce tumors in all, or sev-
eral of them. 'While the target organ may
very from species to species the concept of
species specific carcinogens la not well sup-
ported. The mouse Is probably the most
widely utilized test animal. Is the standard
reference test animal In recently established
and large scale programs of the United '
States Department of Health, Education and
Welfare at the National Center for Toxlcologt-
cal Research for quantltatlon of toxlcologjcal
and carcinogenic risk, and was extensively
utilized, perhaps reluctantly, by the labora-
tory of the Shell organization at Tunstall.
England." . -
The following analysis by Dr. TJmberto Saf-
flottl. Associate Director for Careinogen'esls.
Division of Cancer Cause and Prevention,
National Cancer Institute, a. world renown
expert whose Initial testimony-was cleared
and approved by this organization and
whose demeanor and knowledge during his
several days of cross-examination especially
Impressed us. Is helpful In this regard: »
The argument that certain mouse liver car-
cinogens are "species specific" was recenliy
reviewed In a paper by Tomatls et al.= on-
titled "The predictive value of mouse liver
tumour induction In carclnogenlclty. test-
ing—A literature survey." The authors
searched the literature to make a list of-
chemicals that were reported to have Induced
liver tumors in mice: 68 chemicals were In-
cluded in this list. The literature was then
examined for reports on tests of these chem-
icals in two other species, rats ""j hom-
stars. Of these 68 mouse liver carcinogens,
only 18 were reported to Induce only liver
tumors in mice, while the others pro-
duced also tumors In other organs. Of the
18 that were reported to produce only mouse
liver tumors, none was reported to> have
been adequately tested la the other two
species with negative results. Of the
68 chemicals which were reported to induce
tumors of the liver, or of the liver plus other
organs, in the mouse, only 16 were listed
as having been tested and found negative in
one of the other species (rats or ham-
sters); however, of these 16, 0 were reported
as negative in rats but were not tested in
> hamsters, one was reported as negative in
rats but was positive to hamsters. 5 were
reported as negative in hamsters but were
positive in rats. Thus only one compound.
positive in mice, was reported as having been
tested In both rate and hamsters; with
negative results: this compound is
benzo{a]anthrocene which not only causes
hepatoraas by feeding in mice, but'also
causes lung tumors, and was found to be
carcinogenic also by other routes of ad-
ministration in mice, causing tumors of the
lung, skin and bladder. Although this com-
pound was reported as negative in rats and
hamsters. It is Important to state that It
"Also significant is the l..ct that an ex-
perimental study involving approximately
25.000 mice, was established using a car-
cinogen which Is known to produce liver cell
tumors in mice as well as a variety of other
tumor types in mice and in other species.
• "In fact, much of the preceding section
O; these Conclusions was based on the testi-
mony of Dr. Snfflotti, confirmed and cor-
roborated by the testimony of many other
cancer expert witnesses.
FEDERAL 8£CISTE». VOL 39, NO. 203—KHDAY, OCTOBER 18, 1974
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51
NOTICES
•as not adequately tested In rate and ham-
»n at all. There are no reports of such
testa by chronic feeding In rats or ham-
sters, nor of any long-term tests with con-
tinuous administration In large numbers of
animals, with adequate pathology. The only
feeding study In rats on tola compound
was published In 194S *". It states that 2 out
of 3 male rats were found to have 3
hepatomas each. No hepatomas were found
In 3 females, nor In different groups of-
controls. Although Inadequate, this report
suggests the possibility of liver carclnogenlc-
Ity In rata. So the conclusion Is that no
chemical waa found to have been ade-
quately tested and shown to produce liver
tumors In mice but no tumors In the
other two most common species of test
animals. As a matter of Interest. Tomatla
et al have limited their discussion to the
correlation of test results as presented In
the literature, without any critical evaluation
of the adequacy of the tests used to enter
a classification of positive or negative Into
their tables. Such an analysis would show
that many tests la rate or hamsters, re-
ported as negative, are really quite inade-
quate and should be rejected as "negative
evidence."
The survey by Tomatls et al. Is, however.
sufficient to disprove the proposition that
the Induction of liver tumors In mice Is a
tissue response that Is not representative of
carcinogenic effects such as are seen In
other organs or other species. A few people
have proposed that the carcinogenic response
of mice is not representative of that of other
species Including man No scientific basis
could be found to support this argument."
The Report of the 1973 Joint Meeting of
the FAO Working Party of Experts on Pesti-
cide Residues and the WHO Expert Com-
mittee on Pesticide Residues, which Is not
the official view of WHO but only that of the
participants of the expert committee, stated.
In part, as follows:
• • « The Meeting agreed that there Is a
serious lock of knowledge regarding the
processes involved In the development of
liver tumors by mice and that It would be
unwise to classify a substance as a carcino-
gen solely on the basis of evidence of an In-
creased Incidence of tumors of a kind that
may occur spontaneously with such a high
frequency.
In general It was felt that If the exposure
of mice to a pesticide was associated with an
Increased risk of the development of liver
tumors, long-term feeding studies on at least
one other species should be required. Car-
clnogenlcity tests In two species other than
the mouse would be regarded as appropriate
where It was evident that man might be ex-
posed through food to a dose level close to
one that Increased the incidence of liver
tumor In mice.
utt should be pointed out at this point
that the Tomatls article further stated that
"The present review Indicates that the In-
duction of liver tumors in the mouse should
be considered as valid as the evidence ob-
tained In the rat and/or the hamster at any
site. It does not Imply that the chemical
which has been tested with negative results
In one or more species should be auto-
matically regarded as having a possible car-
cinogenic effect on man solely on the
grounds that rt Induces liver tumors tn the
mouse. Conversely neither does it imply that
negative results In the mouse muse be re-
garded as proof of safety." Aldrin and
dleldrln have not on the basis of adequately
conducted and reported experiments at
proper dose levels been tested with negative
results In the rat and do not appear to have
been tested In the hamster at all.
The meeting agreed that, although the
above 'considerations might be useful for
general guidance. It would be essential for
each pesticide to be considered and assessed
Individually.
This does not detract from the testimony of
Drs. Beston, Safflottl and others with respect
to the significance of mouse liver tumors. The
FAO/WHO report recognizes that the matters
there stated "might be useful for general
guidance" but that each pesticide should be
considered and assessed individually. It ap-
pears to us that the quoted material set out
above from the PAO/WHO report Is basically
the view of Dr. Roe.who testified on behalf
of Shell Chemical Company herein and who
was one of the Tew or, perhaps, 3 cancer ex-
perts on the expert committee. He admitted
st the hearing. In effect, that the members of
the expert committee ran determine the re-
port that Is Issued. For the reasons stated
herein for. In effect, giving little weight to
Dr. Roe'a testimony In this connection, we
similarly so regard the PAO/WHO report."
Wo Just do not believe, on the basis of this
record, that It represents the current state
of our knowledge or the accepted scientific
view. We are. Instead, Impressed by positive
findings in 5 different strains of mice with
differing incidences of spontaneous tumors.
As we stated above, inbred, outbred and hy-
brid mice were Involved In the experiments.
(See also discussion which follows on other
tumors of the mouse, and the rat). Moreover.
Shell's own experiments clearly demonstrate
how natural variability can be surmounted
and an unequivocal result be obtained. For
example, from a consideration of the fre-
quencies of malignant hepatic neoplasms, as
diagnosed by Shell's pathologlsts, it Is ap-
parent their spontaneous Incidence In control
animals la neither high nor variable, while
the dleldrln treated groups consistently show
marked and often high Incidence of such
malignancies.
Shell Chemical Company further con-
tends that a large variety of factors,
chemical and nonchemlcaJ, can greatly
alter the Incidence of tumors In the liver
In the mouse and. thereby, challenges
the appropriateness of the mouse as a
test animal and Its applicability to man.
Specifically, Shell has reference to the
fact that sex, hormones, diet «-M other
factors can influence the occurrence of
cancer In test species. This is well known
to cancer investigators and we believe
the following answer by Dr. Heston to
the matters raised by Shell witnesses
disposes of some of the contentions of
Shell's witnesses in this regard:"
• • • Besides those noted by Dr. Roe,
there are probably many other factors,
as yet undiscovered, which can affect the
Incidence of tumors, and this likelihood
applies not only to hepatomas, but also
to other tumors as well. And, given a
fundamental biological similarity be-
tween the mouse and other test species,
it is obvious that many of the factors
cited by Dr. Roe and others as influenc-
ing the incidence of tumor formation in
the mouse would have a similar effect on
other species as well. It is merely be-
cause we have studied the mouse in
greater detail than other species that
there is a greater literature concerning
spontaneous tumors in the mouse than
in other test animals.
All of Dr. Roe's discussion of factors affect-
Ing tumor Incidence, however, has absolutely
no bearing on the question of carclnoge-
nlclty. Most simply put, the question Is "Can
the administration of Aldrln/Dleldrln to test
animals result In some of their cells be-
coming malignant?"
This question Is answered by selecting two
groups of test animals which have been bred
under the same conditions and which have
similar genetic characteristics. Both groups
should be alike with respect to sex: both
groups should be tested at the same time In
Identical surroundings: both should be given
the same nutrition. In ail respects except
one, In short, the animals of both groups
should exist under the some conditions. The
only difference la that on one or more occa-
sions, one group will be exposed to a known
quantity of the compound under test and
the other will not.
Thereafter the Incidence of tumor forma-
tion and other data will be noted, and
through statistical analysts one can deter-
mine whether any Increased Incidence of
tumors has occurred in exposed animals
when compared to controls. If so, and If the
difference In Incidence Is sufficiently great.
we can reasonably attribute the Increased
Incidence to exposure to the compound
under test. We do not thereby conclusively
prove that the test compound "caused" the
elevated Incidence, as Drs. Roe. Stemberg.
Newbeme and others would require; if we
had to prove causation we could not estab-
lish any substance as carcinogenic even
today. Rather we must and do make Judg-
ments as to carctnogenlclty on the basis of
statistically-significant differences In tumor
Incidence arising from valid experiments
such as I have outlined above, and from other
information at hand.
Whether the particular strain or species
of test animal chosen has a high, medium or
low Incidence of spontaneous tumors Is there-
fore Irrelevant so long as animals are assigned
without bias to test and control groups. The
fact that diet can increase or decrease the
Incidence of tumors becomes Irrelevant to
long as both exposed and control animals
am fed the same diet. All of the other factors
cited by Dr. Roe and others similarly are
Irrelevant so long as they apply equally to
control and exposed test animals.
Does the variability In the incidence of
spontaneous tumors in the mouse make It
an Inappropriate animal for carcinogenicity
testing? Do any of the other factors cited by
Drs. Newbeme, Roe. Stevenson and Thorpe
lessen the value of the mouse In determining
possible carcinogenic threats to human
health? For the reasons I have given above,
the answer Is an emphatic no. •
" Similarly, the only cancer expert on the
Administrator's advisory committee was In-
troduced as a witness for the Shell Chemical
Company, and we feel that the record herein
totally overcomes his testimony with respect
to the significance of mouse liver tumors and
the standard by which cancer risk to man Is
determined.
" It should be noted that the Shell em-
ployee witness with overall scientific re-
sponsibility for the toxicology programs In
Shell's Tunstall laboratories testified that
the laboratory tried to eliminate environ-
mental biases as much as possible In the
various mouse tests on the carcinogenicity
of dleldrln and the record does not Indicate
any such biases In the mouse tests Involved.
Also, Dr. Heston's testimony set forth above
with respect to the Irrelevancy of the mat-
ters raised by Shell was echoed by other
cancer experts herein. Further, vtrtabllitv
In spontaneous tumor Incidence Is found not
only m the mouse, but also In other species
including man.
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 18, 1974
-------
In this connection. It Ic helpful to set forth
detail coma of the testimony of Dr. Arthur
;. Upton. Dean. School of Basic HcaUh Sci-
ences. State University of New York -nt Stony
Drool;, Net7 York, a noted cancer -rxi-vrt. He
states as follows: »
The emphasks hy .Slirll wUnev.'] thul
knowledge of mcch:tit!.t.Ti!i muui !>-• -\r(hicJ
brforo any agent ran Ije- cor.fliUj-rrn rufclr.c—
genie, oven thouch llit.i n-^ni imi iioi-n -leni-
onxtnitcd to Invlucu evrlnoRf nl.. .:i't-:t.i" lu
valid experimental 'ayiitenu, e.in i-^i? iw re-
garded us inlaleadlni', lit cMromc. In fa-.l, In
»|ilti* of A very ofm.'UI-r.iljli: Miirnnit uf rr>-
tcarrli, tho hoale iiir.rh»ni:.mj of nrtiii.i f/f
liny HliiKlu corctnuc.uii hnv- nul yet 1. :rn i-lncl-
daled. ThLi requlrnnunl u( Cincll \vji-.l'l :ul«lllivr.t whMi "m-
diica" cancer.
I would like to turn nnw lo ,1 iliv:v.'.sl»n of
the twsl.1 on which fimilniiscf cnrclno "inlclty
nrc uuido In animal c.rprrtmcnut!.-n. !n pij-
tlculnr. I would Ilka U> iidJiecs t,vm i.n.!nvMng
argument: Even If nn iMcreascd Lnclin'.ncc of
tumors Li found in test rinl'naU a,'|.:r ex-
posure to a particular compound, o".c ran net
properly assert Ui^t lhc test .15^11 1 "L-aiiMrt"
the Induction of such luicnrs; ou-> c \ii .-late
only that a statlstlc.il ur-wclution war. duinou-
straUid between bdinlncLrnlloii of 11:.- com-
putind iiid tha elcvalc-.-! lucldrncr of vi.niors.
Onu must know Uie mcclianlsnu Sy r.-h.Ui a
carcUi^fviilr. respuiixi.- I' ulicllcd liv!^''.- r>no
ran spcuk to tho qur.'.llon of "cuir--i' i.,n" or
lAbcl a teat compound n "c:urcliia;vu".
. X Jo not .tulj.tcrllir to this po.Miiiun. r>i r:\r-
iiOcuiilclly U-fllliiK tr.djy we I>3M- fic.i.'inci of
.ruluuceiilclly on pr^ci'dj- tlio.r. si;. ti'.tli::il
j:rll,Fi[ iliuvo
n* InadviiiniU), nnd 1 l/rlu-vc it tint mil; i>rr>p?r
lint Import anl innl we du NO. Olven '>nr prrs-
filt nl:iLo of knnwliulicn Cutirrrnliii; tit*
Iiicrliitiiliiino of cnrrln,,|-onlrily. 1C nuif ho
K'jinn tlino Itfforn we inn r^llnhty r-iU'ilill.ili
thn cnllrn palhwiiy from ndmliil.'ilr.ti.l.ni at n
curclnocRiitc agent to lh<: cllcltatlriti of i\ cur-
clnuertilc rnspoiiM*, To n-q\ilro U.:.'. such ft
pathway b> estahlislicU In detail U-,'>>ie nn
ii|;ciil mil be lalipllc-l "rfirrlnogrnir" «-mild
tin lit kdopt the a-.lrlrii-lliir position <•( iciinr-
Ing fncts which comt'Uile obvious v/ariitns
/Inps for huinnn heal Mi.
• A fort-moat reason why wo cannot \valt for
a full explanation of mechanisms o: onrcinc—
CeiiftMs Is because of their apparrnt multi-
plicity and Complexity. It la no Ion,;*- rcason-
Rblc to assume that cuneer results frc.n a
slucle fnctor: rather U nppein th:it rnrrl-
noccncaja Is a miilti-cnujnl. niulU-ril.aji«U
prorcsj In which cem-lis, hormonnl. i>ir.-lm!i-
nicnt.il. and other /actors piny vnr>ln;r roles
'In the ellcltatlon of a particular c-.irt.-iiio-
Ecnlc response. At this stage of our knowl-
edge It Is true thnt we run mnke somr pcii-
crnllzatlons conccrnlnR particular fsrlors.
We can e.iy, for Insfuure. that rnanmnllsn
neon.ntrs appear to ho more susceptible to
th* actlona of some cnrclnopens than older
nnl mills; but even hrru one should noli: thnt
the relationship of n£c to tumor Incidence
nppcnrs to vary with Hie lype ff IHHIOT In
mout species slurtk-d. In man. for liv.t.mfe.
Borne forma of cancrr nppoar preili.minnully
nmong children, wlilla others wldont appear
among the younq yrl Incrcnae eiponrniluUy
with nee In adult*. It li bcrnu^o o( tlir.v^ nnd
•tlitr Oinrply dlfftrrini; puttcrnj of cnurrr In-
52
NOTICES'
cldence In man and other mammalian spe-
cies that the process oi carclnogenesla ap-
pears to Involve & large number of variables
and highly complex series of Interactions.
Hence It Is doubUut that vo will understand
fully tho mechanisms nf even *^» simplest
forms of cnrctnoRenesIs In ll>» mmedlate-
future. " '
I«»ca.us« of Incomplete knowledge eoneem-
Inp mfrliniil.iiri.i, I also du nnl licllore Ulat
dlt.UMcl.lims lietwren "mrclnoifsn.i" and "eo-
carciii";;i-i\b". or between "nvu.snti»« agents"
anil "mil indue aijtnta" can bt» considered
reirvitul I'rflav when nwrtnlnlnp hazards
lo liitTT-iin hrnlth arising irom carcinogona.
In JVifriy t'.-ntliiG of cnrclni^irns today wo
are ci""'*r'\i~tl with ona (jitrutlnn: "Does ox-
po.Mirf to tur trst agent result In a nlgnlfl-
caiit Iniliirlion of tumors In ciM;ui suedes Is a confirmation of
the uimMnoKcnicity at tho U-st agent, but
It is not necessary riefore a finding of
carclr.r.c.-iilcity nnd threat to human
hcsiltli cnn be mride; and nccnllva results
In rx *i:cu!ui or even third Kperlcs of test
tuilnn! do not In my mind establish that
the test urcnt Is not a threat for human
bcliiti. Given the vnHnllun in human
susceptibility to carcinogens. I believe
it unreasonable to Ignore a flndlnj of car-
clnorti'iiir.'ty in any mammalian test spe-
cies vhon considering possible effects on
humun health."
We Iinve limited our considerations above
•with rtjpect to tho carclnogciilclty of dleldrln
to the results la the mouse nnd specifically
la tho mouse liver. We tbuite It Is clearly a
carcuioi-.cit solely on that, baals. (S*« also
Part III of'tbesa Conclusions). But. wo are
not re.s'.ncti-d by the record solely to that
organ In tho mouse or solely to that test
anlmsl. Wulle tho effects of dleldVta wera
manifested primarily In the liver of the
mou.v:, there was alao statistically significant
Increa/ves of tumors In the lung and other
organs of the mouse In some of the experi-
ments ns published and also with the newly
introduced but questionable revised data.
Erwi with the revised data, It la cleixr that
dleldrln at low feeding levels, at either 0.1
"See nl&o testimony of Dr. Samuel Kpstcln
In Ilia consolldnlcd suspension prurccUln^s
(KDP Exhibit Ko. 3 3). A3 part Ilicrvof he
atntcd:
• '•In nditltlon, on crosa-exnmlnntlon this
vltnes* (iidlrnttd that mutters such as casein
and diet wlilch reflect tumor Incidence In the
mau.iff eoutd conceivably bo similarly ctvrclno-
pcnlc In ninn under certnln eruditions. On
the baiil* of our current knowledge, we clearly
cannot alnlo with certainty that tho factors
eltrd by Shell as Influencing the occurrence
of liver tumors In the mouse cannot similarly"*
lncreo.se tumor Incidence In mab in the llrer
or elsewhere.
ppm or both tho 0.1 aJOd 1 ppm lerels. can
elerato the Incidence of tumors at sltca other
.than the UTCF and that this eleratlon U
highly significant In either males of fcmnJes
or la botn sexes, as demonstrated by Dr.
Gross, a veil qualified statistician and can-
err expert, by conventional and accepted
statistical analyiils. Thesa nadlngs trnd V>
corroborM* the cnrclnogenlclty of dleldrln
In the mouse.' as evidence*1 by the motion
of the mouM liver to dleldrln. tbo appllca.
bllltr of that Qndlnj to man and to wraken
Sl.fli's argument! baaed exclusively ou the-
liver of the mouse.
ALio. thort It esrxTloiirc wltb tho nvt. We
nre hesitantly unwilling at thtf time to find
that dleldrln Is conclusively a carcinogen
In thn rat nlthoiiRh there are Indications
that this Is so especially when the ehemjcnl
l.i tasked at.tho lower doispe.i. This Is the
CA.-
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53
NOTICES
ceptlble advanced ages after any reasonable
duration of treatment must be small and that
these patients are apparently dying of com-
peting causes before cancer develops or are
still too young to develop many cancers.
Although the study was age adjusted, the
participants therein or subjects th-jr-of were
tco young for meaningful or conclusive anal*
ysls. This Is also the view of Dr. Marvin A.
Schnelderman. Associate Director for Field
Studies and Statistics, Division of Cancer
Cause and Prevention, National Institute, a
well qualified blometrlcian. He further con-
cludes that "the data here are consistent with
the possibility that the anUconvulsants
which the epileptics received Increased the
risk of liver cancer, perhaps two or three-fold.
Thus, In the case of phenobarbltone, the
mouse may Indeed b(y) an appropriate model
for human cardnogenesis." Dr. Schneldenrmn
lists many other reasons for his similar dis-
agreement with Dr. Clemmesen. In short, we
do not believe that the non-cardnogenlclty
of phenobarbltal to m
-------
mats are not-clear, to say nnttfing of the
stabollc processes In man. Mo one as yet
can. draw any valid correlation between a
particular pattern of mfitaholl-an and the In-
duction of canc«r In any species, and any
judgments concerning carclnogenlclty or lack
tnereof baaed on metabolic patterns have
no scientific basis at this time." This obser-
vation related to the testimony of Dr. Hutsoa
adduced by SbeU with respect, la part, to
the rate of metabolism and carcinogenesls.
As observed by Dr. Farber. "Suffice it to say
that while metabolic activation Is essential
to carclnog«uek.!3, no correlation between the
degree of mev.bolle activation and carcino-
genic risie has been established by anyone
for any compound tested In any species to
date." u
IV. In the absence of conclusive evidence
derived from studies in """* for either the
safety or the carclnogenlclty of aldrln/dl-
eldrin, we are forced to make a judgment as
to the potential hazard posed by dleldrln to
man on the basis of experiments with ani-
mals. The scientific community has accepted
the results of laboratory experiments with
rodents as an Indication whether chemical
agents are likely to be carcinogenic In ""»".
as has the Congress as reflected In the De-
laney Amendment. Reliance upon ontmivi
studies Is possible primarily because the
pathological processes of tumor development
in man are very similar to those of other
TT.nrr.rrn.llan speCleS.
Sollance upon «™t»n>i studies Is supported
by experience as well as by the pathological
similarities of man and animals. Many chem *
icats which are known or suspected to be
carcinogenic In man were first Identified as
carcinogens In mice. These Include coal ant.
tobacco tar extracts, polycycllc and heterocy-
cllc aromatic hydrocarbons, estrogens, and
'arbon tetrochlorlde. Furthermore, as stated
•Her, all chemicals which are known to
.use cancer In man also have been shown to
produce cancer In laboratory animals, with
the possible exception of trivalent Inorganic
arsenic which Is still under study.
This Is not to say that the biological proc-
esses of mice and men are Identical In every
respect. Chemical carcinogens, for example.
may affect different target organs In different
species. Generally, however, there are suffi-
cient similarities in the metabolic and bio-
logic processes of experimental animals and
man to indicate that on agent causing cancer
In rodents or other experimental «jtifimi«
poses a high risk of causing cancer In man.0
The record is replete with evidence. In fact,
overwhelmed with evidence, some of which
has been set out above, that such is the case
here. We believe that this conclusion repre-
sents established traditional and "conven-
tional wisdom." The Shell Chemical Company
has strenuously and .with sophistication at-
tempted to demonstrate that "this truth"
does not apply to aldrln and dteldrin for the
reasons we have detailed above. We do not
» At the oral argument herein at the close
of the hearing. Shell Chemical Company set
forth for the first time a S stage scheme for
dleldrln Induced tumor development In the
mouse- liver and contended that.4 of those
stages were only found In the mouse. Such Is
not the case.
** Dr. Heston. a noted geneticist with much
experience, testified as follows In this regard:
Th» Stisian population Is so mica more
genetlcnllj diverse than any laboratory ani-
mals that If a chemical has been shown tc
be carcinogenic by a significant Induction of
any kind o£ tumors In any laboratory strain
or mammal, we can reasonably expect that at
least certain human beings would also re-
>oart to the chemical by developing some
nd of neoplasm.
54
NOTICES
believe that traditional wisdom or science has
been overcome thereby. Shell's presentation
with, respect to the shortcomings of the
mouse as an appropriate test ^TiifMoi nr\tt its
lack of sig»iui««.«i.nd immediacy in view of the fact that the
eatlre population of the United States Is con-
tinually exposed to these chemicals and that
dleldrln has probably accumulated la the
body tissue of almost every Individual. Dlel-
drln Is stored In human fat, circulated In the
blood, transferred across the placenta to de-
veloping fetuses and secreted la human millc.
Dleldrln Is a persistent chemical which per-
vades our diets at significant residue levels.
Additionally, man Is exposed via the air and
other routes. No useful purpose would be
served and time does not permit the listing
In great detail*> of the quantities and extent
of dleldrln found in humans, in human ma-
ternal mlllf. and In foods or describing In
detail the fact that the agricultural uses of
aldrln and dleldrln result In much of the
dietary exposure of dleldrln to """V It Is suf-
ficient to state tnat dleldrln Is found In sub-
stantial amounts In humans and In our diets
and that a significant source of that dleldrln
"See section 164.131 (g) of the rules of
practice. See also e.g.. Stearns Electric Paste
Company v Environmental Protection
Agency. 461 F. 2d 393 (7th Clr. 1973): Con-
tinental Chemlste Corporation v Ruckels-
baus. 461 F. 3d 331 (7th Clr. 1973); En-
vironmental Defense Fund. Inc. v. Buckels-
haus. 439 F. 3d 584
-------
55
NOTICES
as substitutes for aldrin and dleldrln. Shell
contends that "By Respondent' a late reversal
of Ita position with respect to heptachlor and
chlordano availability and use as a da facto
alternative to aldrin In 1979, Shell has been
severely prejudiced In presentation of Its
ease" In violation .of the notice require-
ments of 9 U.S.C. S64(b). We find no merit
to such argument."
The additional arguments advanced by
Shell Chemical Company In connection with
the availability of heptachlor and chlordane
In 1975 are all bottomed on the premise that
"the evidence demonstrates that heptachlor-
heptachlor epoxlde Is as much, or more, a
laboratory carcinogen as aldrln-dleldrln."
This la not the case at this time. Those argu-
ments must fall.
VI.' As stated earlier, our consideration of
'"Imminent hazard" with respect/to aldrin
and dleldrtn must take Into account "the eco-
nomic, social, and environmental, costs and
benefits" of these pesticides. In other words,
even with respect to "imminent hazard" a
risk-benefit analysis la required by the
statute. CP "e.g.. In re Stevens Industries,
Inc.," 2 Ei,.R. 30011 (June 2, 1972), affirmed
•Environmental Defense Fund. Inc. v. En-
vironmental Protection Agency." 489 F. 2d
'1347 (D.C. Olr. 1973): "Environmental De-
fense Fund, Inc. v. Ruckelshaus," 439 F. 2d
684-(D.C. Clr. 1971).
Prior to analysis of benefits, It must be kept
In mind that'the risk wo are dealing with.
Is that of cancer, a matter of grave concern.
"Environmental Defense Fund v. Environ-
mental Protection Agency." 46S F. 2d 528. 538
(D.C. Clr. 1973): "Environmental Defense
Fund v. Ruckelshaus. supra." Moreover, we
must seriously heed the admonition of the
Court In the latter case wherein It Is stated
that tbe Delaney Amendment to the Federal
Food, Drug, and Cosmetic Act Indicates "the
magnitude of Congressional concern about
the hazards created by carcinogenic chem-
icals, and places a heavy burden on any ad-
ministrative officer to explain the basis for
bis decision to permit the continued use of
a chemical known to produce cancer in ex-
perimental animals." 439 F. 2d 584, 696, fn.
41 (D.C. Clr. 1971).
On the other hand, we must seriously con-
aider the 1975 com crop, especially In view
of the drought this year which has some-
what diminished expectations, its Importance
and the possible effect of a ban of the use
of aldrin thereon during the time It will take
to Issue the final decision In the consolidated
.cancellation proceedings. As seen from the
Findings of Fact, aldrin use far exceeds that
of dleldrtn and the major use of aldrin Is on
corn.
Corn Is the world's principal grain used for
cattle, hog and poultry feeding and Is an
important food grain as well in certain coun-
tries. We ore extremely conscious of the im-
portance of the 1978 corn crop to protein
food production and the economy. World
grain stocks are at the lowest level In more
than 2 decades. Despite generally larger crops
elsewhere, the smaller than expected U.S.
corn crop this year due to weather conditions
will prevent rebuilding world stocks this
year. It'will be necessary to await next year's
crops before there can be hope of rebuild-
ing such' stocks.
But, we do not believe that the availabil-
ity of aldrin or lack thereof will significantly
affect the 1973 corn crop. Stated another way.
It appears to us from the record that the
necessity for aldrin In the production of that
crop and the consequence •of Ita unavail-
ability have been exaggerated.
To place our Inquiry In proper perspective,
It should be noted that aldrin Is utilized on
only approximately 8-10 percent of the acre-
age devoted to corn production and that some
of Its use thereon Is actually unnecessary.
In other words, aldrin Is often applied as
"Insurance." As with much Insurance, the
covered risk does not occur and would-not
have occurred even In the absence of the In-
surance coverage. This Is not to say that In
certain situations the need for Insecticides
Is not more apparent than In others. In ad-
dltton. there Is some evidence of record that
corn soil Insect populations are at low levels.
Dr. John Schnlttker, a former Under Secre-
tary of Agriculture of the United States who
has much experience and expertise with re-
spect to the economics and marketing of feed
grains testified on behalf of respondent In
these proceedings. He assumed, for the pur-
pose of his testimony, that the absence of
aldrin would result In a 1. 2 or 3 percent
diminution, in the corn crop and projected
the consequences of such, reductions.3
Dr. Schnlttker's testimony Indicated that
the overall economic effects of-the ban of
aldrin for use of corn depend to a great degree
on the extent of the future demand for grain
Imports which will b» placed on the United
States by other countries, as well as on a
variety of facts affecting the supply -of corn,
such as the supply of suitable land, tech-
nological developments In corn breeding and
husbandry, demand for other agricultural
products under soil and climatic conditions
to which com Is well adapted, federal farm
programs, weather conditions and fertilizer
availability. The unpredictability of sucn
factors aa weather make projections about
future com harvests In specific years ex-
tremely difficult as the recent drought In the
corn belt demonstrates. In this connection,
however. It appears to us that the reduction
of the I9T4 corn crop below expectations
would, In terms of Dr. Schnittker's analysis,
result, in effect, in shifting. In part, his
estimates and consequences for 1974 to 1976
since the same basic capability to produce a
corn stockpile from next year's crop would
remain.
Dr. Schnlttker concluded that the current
situation prevailing In the grain market Is
abnormal and short term, resulting from the
somewhat unprecedented crop shortfall of
world grain In 1972 and 1&73 which necessi-
tated a depletion of accumulated reserves. He
predicted a general reduction in the Import
of grain by all countries because "the magni-
tude of the decline) in world grain production
In 1972 appears to have been principally the
3 As Indicated above, there was no reversal
of position with respect to heptachlor and
ehlordane availability.
9 Such testimony was received 'In the can-
cellation proceedings, and his projections
were not specifically related to the 197B crop.
Nevertheless, they are valid for these suspen-
sion proceedings. In any event, we cannot
conceive of a 3, 2 or perhaps even a 1 percent
reduction in the 1975 crop by virtue of the
absence of aldrin. There Is In reality no good
basis In the record to predict such a loss
probably approximating over 60, 120 and 180
million bushels of com at the 1, a and 3 per-
cent reduction levels, respectively. (See dis-
cussion which follows).
result of events which should not be expected
to recur regularly." He further stated that
"the> analysis of agricultural production
potential and targets • • • leads to the con-
clusion that success In expanding production
Is possible and probable In most countries
and that U.S, grata exporting capacity will
not be tested every year until the end of the
1970's."
In short. Dr. Schnlttker found very little
macroeconomlo effect of even a 3 percent re-
duction In corn production, a reduction
which he considered to be well beyond any
known estimate of the actual Impact to be ex-
pected from the unavailability of aldrin. We
are in full agreement with both of these con-
clusions. This Is not to say that we are not
very concerned about possible effects of sus-
pension upon Individual fanners, a matter
we shall discuss in the next part of these
Conclusions.
While predictions and projections ore haz-
ardous for obvious reasons, It appears that
the planting of additional acres to compen-
sate for any reduced yields would nullify any
price impact at the national level and even if
no additional acres were planted to offset any
yield Impact the price of corn would Increase
by only 1.5 to 5.8 percent for the 1 and 3 per-
cent reductions.
But, as indicated by footnote 29, we do not
believe that a 3 percent reduction In yield
could result from the absence of aldrin in
1978. In fact, we seriously doubt that even a
one percent decline would result. We have
been casting about In these proceedings for a
reliable estimate of the reduction In yield
that would be attributable to a suspension or
cancellation of the use of aldrin In the pro-
duction of corn. One of the obvious problems
In this connection Is an Inability to deter-
mine what would have been the case If aldrin
had not been used. Aldrin Is In part utilized
by farmers as "Insurance" and may not have
been actually necessary at least In some very
substantial number of Instances.
We totally reject the Doane Agricultural
Service, Inc. special survey and projections
of loss adduced by the Shell Chemical Com-
pany. On Its face, It la patently exaggerated,
employs "double counting compounded." Is
based on a small sample from which amazing
projections ore made and elicited the views of
aldrin users who would not In reality,know
with any precision the effects of the absence
of aldrin and who, It seems to us, would
demonstrate a bias. Such survey, it also
seems to us, was biased In Its design, re-
sponses and presentation of the survey ques-
tionnaire and results and displayed other
weaknesses such as statistical deficiency.
Similarly, the very rough study of Dr. Freund.
which was only Intended to be a tentative
and preliminary work, cannot be relied upon
as indicated by the report Itself which states
that "the assumptions are extensively quali-
fied and for firm conclusions, more data on
many aspects of the study are needed."
It appears to us that aside from the mat-
ters mentioned above, the only economic
study offering some reliance Is that of Dr.
Herman W, Delvo, Agricultural Economist.
National Economic Analysis Division, Eco-
nomic Research Service, United States De- '
partment of Agriculture, entitled "Economic
Impact of Discontinuing Aldrin Use in Corn
Production." Issued June 1974. Dr. Delvo uses
data accumulated from the USDA 1971 Farm
Production Expenditure Survey to establish
the use pattern of aldrin In 1971. He relies on
consultations with entomologists In the Corn
Belt states to estimate overall losses In the
event that aldrin. heptachlor and chlordaoe
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 18, 1974
-------
56
.» not available for use.9 Dr. Delvo esti-
mates that the overall loss In 1971 in corn
production, would have been. 19 million
bushels for tae Cora Belt states and a total
of 21 million bushels tor the entire nation
where farmers nuke use of alternatives to
aldrin (Bus, M» footnote- 30). II farmers did
not us» alternatives, he estimates the 1971
1034 at 51 million bushels for the Corn Belt
states and a total of 93 million bushels for
the United States. Even adjusting for 1975 In-
creased acreage over 1971 acreage and con-
sidering the fact that, perhaps, use of aldrtn
for rootworm control majr have been over-
stated, the o-itlmated loss In this study
where farmt.-i utilize alternatives Is much
below one percent of estimated production
and may reach one percent If alternates. In-
cluding heptachlor and chlordane. are not
used, a situation which Is Improbable."
Confirmatory of the general conclusion of
Dr. Schnltiker. Dr. Delvo found very little In
the way of macroeconomlc effect resulting
from the absence of aldrin as an Input in
corn production. In fact, he found a 0.8 per-
cent Increase In price with use of alternative
Insecticides and a 2.2 percent Increase In
price without alternative Insecticides with
fanners showing a net gain.
On the bests of the foregoing, we cannot
And any major economic or social benefit re-
sulting from the use of aldrin on corn In
* In the consolidated cancellation proceed-
ings heptachlor and chlordane, which are
admittedly as effective as aldrtn. were we
proposed as alternatives thereto and our con-
siderations therein were limited to alterna-
tives to aldrin other than these 2 Insecticide?.
It appears, however, that approximately 3.-
000.000 and 1,000.000 pounds of technical
-atachlor and chlordane, respectively, will
available for use. on corn In 1975. We can-
-ot ignore such fact In assessing the effect of
a suspension of aldrin on the 1973 corn crop.
Consequently, Dr. Delvo's estimates must be
considerably reduced since he did not Include
heptachlor or chlordane In arriving at his
conclusion. In reality, his estimates of loss If
farmers used alternatives must be reduced.
perhaps by 20 to 40 percent or more as testi-
mony In these proceedings Indicate that
farmers would switch to heptachlor and per-
haps, chlordane. the efficacy of which Is not
In question. In addition, such estimate was
basvd on the supposition that the other al-
ternatives would not be as effective as aldrin.
This may not be so at least with respect to
newer alternatives for use against the wire-
worm. We make further observation that
many and. perhaps most farmers do not
apply aldrin as directed for heavy wtreworm
or cutworm Infestations and losses from such
infestations might not be so different with
aldrin or an alternate treatment. Also, we
note that some of the entomologists with
whom Dr. Delvo conferred have testified in
these proceedings for Shell or for respondent.
n We do not at this time know cora plant-
Ings for 197S but we assume that they should
approximate 1974 plantings and that produc-
tion estimates should be similar for both
years especially In view of the present price
of corn. In this connection, we also believe
that most farmers wilt use alternate chemi-
cals, even If more expensive than aldrin. be-
cause or (he favorable price picture and the
fact that pesticides represent a relatively
small part of the cost of production. In an/
erent. we cannot make estimates of. or on the
basis of. failure of farmers-to use alternatives.
V.v-.t Importantly, we do not necessarily agrt -
by nrtue of the above analysis that losses
woi-.ld be as high as'stated by Dr. Delvo. We
*.ave merely used his paper as a frame of ref-
•ence. We believe that Dr. Dejvo may have
verestlmated losses due to wlreworm and
cutworm damage.
NOTICES
1973 In the context of overall effect of lt»
unavailability for such use. In other words.
we could not meet the burdsh placed upon
us for continued use by the Court in "En-
vironmental Defense Fund - Ruckelshaus."
supra at footnote 41." It w.vii-j be strange.
Indeed, to allow the use of aldrin for the
197S corn crop and thereby continue to
jeopardize the health of the American people
in order to place a relatively small amount
of corn into the world stockpile. Concern
expressed for starving people abroad can be>
met or satisfied by other moans it seems to
us. if necessary.
VH, We turn now to the Impact of the
absence of aldrin upon Individual corn farm-
ers, also a matter of great concern. It must
be remembered In this connection as well
that considerable Quantities of heptachlor
and chlordane will be available In 1975 and
those farmers who feel a need for aldrin may
avail themselves of these alternates to some
extent.*3
Initially much was said of the "com soil
Insect complex" consisting of some 20 soil
insects that attack corn. Upon analysis, how-
ever, it appears that there are generally only
3 and possibly 4 Insects that can be of eco-
nomic significance with respect to damage
to corn, namely, the corn rootworm, cut-
worm, wlrewonn and. perhaps, the white
. grub. These Insects have varying degrees
of importance. Tha other soil insects attack-
ing corn are not usually even treated for
with pesticides. Shell Chemical Company did
not include them in a proposed or suggested
limitation on use offered by It In these pro-
:eedlngs and we shall confide our considera-
tion to those Insects specified above.
The corn rootworm Is by far the major corn
soil Insect pest In the Corn Belt and attacks
continuous, as distinguished from, first year
corn. Two of the 3 varieties or species of the
corn rootworm, .that is, the Western and
Northern com rootworm, are now resistant
to aldrin and.are found In much or most of
the major corn producing area of the coun-
try. There are many organophospbate and
carbamate Insecticides which effectively con-
trol the resistant'corn rootworm and alsb the
nonreslstant variety. Consequently, we do
not consider the com rootworm In our deter-
mination with respect to the need for aldrin
as this pesticide 13 not used la much of the
Corn Belt for the control of this Insect and
to the extent that It is so utilized to control
the nonreslstant com rootworm it may
readily be replaced by those chemicals em-
ployed to control the resistant variety.1*
The next major soil Insect pest of corn is
th,e cutworm and we shall discuss It below.
The wlreworm and. perhaps, the white grub
are also economically significant pests of com
but to a much lesser degree than the root-
worm or the cutworm. On the basis of the
* Shell Chemical Company In Its pretrlal
brief in- the consolidated cancellation pro-
ceedings did not. la reality, contend for a
maeroeconomle effect resulting from the ab-
sence of aldrin and several 01 the entomolo-
gists called by Shell as witnesses agreed that
its unavailability would not have such an
effect in their states.
D We do not consider ' i these suspension
proceedings, as distinguished from a, can-
collation proceeding, sucl basic questions as
biological control wlthov the use of Insecti-
cides, possible new res^tanee of insects to
aldrin,- possible resurgence of Insect popula-
tions absent aldrtn, etc.
»Respondent advances a theory that the
substitution of organophosphate and car-
bamate Insecticides for aldrin for control roceed!ng they
property must be considered as viable
alternatives.9*
Additionally, as we have stated, the wire-
worm is generally only a significant problem
to the individual farmer when certain rota-
tions are followed. Since' we are only con-
cerned herein with the 1975 com cropl'the
fanner. If he anticipates problems In the
absence of aldrin and does not care to apply
or cannot obtain one of the possible alter-
natives Including heptachlor and chlordane,
may to a large extent solve his problem by
the rotation he chooses."' For example, a
farmer may grow soybeans a second year, a
crop which is not greatly affected by the
wlreworm. or may plant sod or pasture in
soybeans rather than starting- Initially In a
corn-soybean rotation, although there Is
probably very little sod or pasture now avail-
able. However, the corn-soybean rotation Is
probably the most insect free and. does not
present a great wlreworm problem In the
rotation from soybeans back into com. We
recognize that this may somewhat restrict
some relatively few farmers, but, in the con-
text of these proceedings, such restriction Is
necessary. As much of the corn land Is in
continuous corn, we do not believe that great
number? of farmers are faced with this
choice absent the availability of aldrin in
1975.
The insect which gives us most concern In
connection with its affect upon the Individual
"We cannot, it seems to us, consider prom-
ising alternatives that are; perhaps, in the
"registration pipeline" but are not as -yet
registered. Mention should bo made, how-
ever, of section 3(f) (2) of the act (7 U.S.C.
136a(fJ (2)) which provides, to part, that "as
long as no cancellation proceedings are In
effect registration of a pesticide shall be
prtma facie evidence that the postlcult. its
labeling and packaging comply with the
registration provisions of the Act.- \Ve
should state, however, that promising Addi-
tional alternatives ore In f •? "pipeline" anrt
we surmise that they probably will be regis-
tered for the 1975 season.
* Alternatives, other than heptachlor and
chlordane. are listed In the Findings of Face.
We do not rate their respective merits. The
farmer concerned about wlreworm damage
.oust consult his state extension entomologist
for recommendations with respect to his In-
" Rotation can also solve the problem of
the blllbug and white grub to a great degree.
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY1. OCTOBER 18, 1974
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57
U the cutworm. Unlike tbe wlreworm,
in cutworm la generally a problem asao-
mtad with gcueriiphy. soil »nd weather. In
other words, Uio cutworm la an/violated gen-
etully with poorly ilrtUnrd river bottom land.
heavy tolls and low wet spots In upland fields.
and rotation docc not play a majcjr_role in
connection ihtrewitn except to some eitent
on Oral year turn following sod or legumes.
There dose not appear to now be an effec-
tive preplan! or planting lima Insecticide tot
Ui« control or tlie UlacK cutworm. nltbouRA
oeveral Inaecttclim with unknown elfeetivo-
ncia are lu tho 'registration pipeline." in-
•lend. tb« currently available allcrnstlve to
ahlrla preplan* ucntment under curn Is the
application of ;«. •' :-uieruent spray: and. baits,
that la, after Viic Insect baa actunlly ap.
peored. Phllo.io|iblcally and aa a practical
matter, this method of treatment nan tbe ad-
.vantage at treating (or Known Insect lufeaU-
tlon and the avoidance of an "Insurance"
treatment of entire flokls where the Insect
may not appear, miiy ouly attack part of a
fluid or nny appear but not In numben of
economic slgnlfiuuiica.
An entanioln;l.<.l prenented by tho Shell
Chemical Company imU others tcntlflcd that
tbe poet ouicir.viit halta ere u clfcctlvc as, or'
bettor, than, a one pound per ncro hand or
row application of aidrtn against the cut.
worm which l» not a* effective u & 3 pound
per acre, broadcast application thereof. The
lower rate of application or sldrln Is not
effective against a heavy black cutworm In-
fcatMlion, but mauy. If not moxt, of the
fanvern apply aidrtn at tho lower rate. In
other words, they nre willing to settle for lu*
than tho best Uentmcnt. Thla cho\ild bo a
factor, perliaps, in evaluating the sprays and
baits aa substitutes for akJrin and the actual
•ecesalty for any treatment. In auy event,
\e record supports the conclusion that post
..nergent treatment of blade cutworm, tbe
major cutworm pcit, with bolts Is efficacious
with post emergent sprays having lesser
effectiveness.* '
nowerer, post emergent treatments for th«
blade cutworm has several difficulties or dis-
advantages. In onler to bo effective as altar-
natives to preventive preplant or planting
time applications of aldrln. the baits or
sprays must be timely Applied. Thh requires
that tbe farmer observe his field* carefully
during aa approximate 3 to 4 weak period
when the oorn lx.-«lns to emerge. This does
. not mean tlukt all farmers need obsnrve their
fields or that those farmers with a auwicct
cutworm prolilotn ncvd observe all their
fields. It does mean that the fainter wbo
hoe had cutworm problems In the recant
.past must chock fcey survey spots in hlj sus-
poot fields. While a 6-atata cooperative
survey Is dorelopluf a scouting sys-
tem, we are nol, we believe, at the point
of hitting avBlUitla commercial scouts or
commercial scoutlnu of farmers fields for
cutworms. Bather, the Individual fanner, his
family or employees er even' high school
students could scout or wallc select portions
of corn fields In an attempt to detect early
elgns of cutworm damage. Such damage la
more readily rucogulTable than damage
fcaused by other Insects. We recognize that
tola Imposes a burden on tba farmer at
perhaps bis busy time of year.
Concomitant with early detection of cut-
worm Infestation Is the necessity for rapid
;. NOTICES
treatment wltfc balta of iprari. II tbe farmer
ooacrrea early cutworm feeding damage he
has several day* in which to apply a bait or
spray inaectlctd* to protect th« crop. The
•balU will then prevent further loss of *tand
and auy cut corn will huve- an opportunity
to rogrow. However, unrirr pitrrme dry or wet
corMTHoos, the 'bait'' Insecticides may lose
•erne of their effectiveness. An entomologist
presented by respondent testified that 75 to
80 percent of the Illinois com farmers have
.obtained good to excellent black cot-worm
control with peat emergent baits.''
As con be seen from me prior discussion,
the use of post emergent baits and sprays
in lieu of aidrtn presents extra effort and
some- additional uncertainty. We do not want
to leave the Impression, however, that cut-
worm lora Is Irreparable. Should a Held or a
portion of a died suffer sertoua cutworm
damage, tho farmer nan the option of te-
plontlng corn thoreon. In fact, thli la usually
done. It \a recognized that In tliirt «v«nt tho
farmer suffers the coati of replanting and
«uff«n» some loss of yield due to the later
planting. But, with the current price of corn.
the farmer will most Ilkriy receive a pron table
return from his corn production, which re-
turn will, of course, he reduced from what
Jie would have experience*, in fact, a farmer
may Initially plant corn later on suspect
acres and, perhaps, avoid cutworm lulury.
In thin event, he would nutter some loo of
yield due to lat» or later planting. In addi-
tion, heavier seeding Is also a valid measure
the farmer can take.
Farmers generally are. not thnt familiar
with Iho use of nost emr-rijrnt treatment* or
with scouting. There spnears to us adequate
time to prepare for such matters prior to
plantln; time In 1978 which shall probably
betrln iiroundAorU 13. J973.
We do not lightly make these nndtaRs us
we do not desire to cause additional burdens
and uncertainty to farmers who havs- a his-
tory of cutworm problems.** But. It appears
to us that there Is a relatively adequate al-
ternatlvn to aldrln In tho treatment of tho
black cutworm and therefore we cjinnot con-
clude that during 1873 aldrln use should be
continued for thla purpose In view of our
conclusions as to the risks accompanying
aldrln." We do not expect the corn farmer
"Most liatea now recommend the post
•nergent treatment as an emergency treat-
ent. It should be stated at this point that
/Iseonsla has banned the use of aldrln on
corn and that tho Illinois state recommenda-
tions do not Inculdo aldrln. Instead, the post
emergent treatment Is recommended.
"The snndhllt and glassy cutworm cnuje
special concern aa they arc .tubterranean
feeders and the bait Is prnhahlj Inadequate.
These cutworms aro nol u-tdospnuid uid there
Is sonic Indication In the record that band
treatment of Dunhau, Dyfoimle. Mocnp and
Dlazlnon could be effective u to Diem.
* Another, uncertainly presented ' for tho
record la the availability of the alternate In-
secticides In 1973. There need not be a pound
for pound displacement especially with re-
spect to post emergent treatment. Hepln-
culor and chlordane ore available. Insect pop-*
ulatlons appear to be nt low levels, rootworm
Insecticides rjlvo tome control of wlreworms
and perhaps cutworms and oltlrtn has been
overused In the past. We agree luat the situ-
ation will be tight. We olio believe, however.
that this decision will generate some addi-
tional alternate pesticides to the extent that
Is possible. Also, any existing stocks of oJolrlu.
if any, could be utilized and the Inter-
mediates contracted for by Shell could pos-
sibly be available for additional hcptachlor
production.
" Some of the parties primarily In tbe can-.
cellatloa proceedings have taken the view
that proposed alternatives need be aa effica-
cious as, and no more costly than, tbe chem-
ical at Issue. We reject aucli a standard es-
pecially whan the risk at band is aa ominous
a* cancer.
wbo haa cutworm problems to Uio this con-
clusion, we have, perhaps, imposed some
oooroua burdens upon him. The act nukes
this requirement. w« believe. If the post
emergent alternative Is not acceptable to
some farmers of bottom land, they have Ux«
option., per tisps, of plnjitlng other TMdfrops
during lhat •MaoSHTmbTwnn'ff "Soyoeana
whJcb, Is another. Important feed crop. Should
•ome of thla acrcaco be lost to corii In 1078.
U»e replacement thereof by wmc other feed.
• crop Is merely a trsdo off w» believe.
To summarljo, we cannot Justify the uiu»
of aldrln under corn In 1975 botii from •>
muCToeconoralc or mlcroeconoinlc stand-
point.
VIII. Aidrtn la also utilized for control of
the F'uller Ro?e Beetle In Florida, one of the
more minor citrus pests In that State. While
sales statistics adduced by the Shell Chem-
ical Company Indicate that this Inseetlelcto
Is sold and used OT cltnis In murh of Flor-
ida, expert wltneetoa presented by Florida
Citrus Mutual, n major grower or^nnl/ntlon.
Ustiaert thnt the economle ilgnlflcance of
the Fuller Resv 13»«tle la very elrHimxerlliert
freofrrnphlcxlly In ihut Stita. Of the 1)77000
acres of citrus in Florida, the rose beetle la
only present In numbers lulflrtpnt to com-
mence to reduce yield on between 10.000 mid
90.000 acres. The urea of I'irninfant Infesta-
tion is essentially the Indian Rlrer arcn of
the Southeastern irnljonrd of Florida, fui area,
characterized by poor Internal soil dralniVKe.
a high water table, and consequently unusu-
ally shallow cltnts root systems. L«ss thru*
S percent of the total citrus acreage in Flor-
ida lias been treated -with any soil Insecticide
for control of any Insect and even within tlie
Indian River Fuller Rose Beetlo trouble re-
gion only 30 percent of the acreage hnj beoa
so treated.
In, a tvpleal Indian River grove, approxi-
mately 73 percont of the feeder roots of citrus
trees ore located wllhlu 10 Inches of the top
of the, ridge of sou upon which citrus trees
are usually planted In that are*. Such trees
are distinguishable by particularly restricted
root systems with unusually limited sup-
plies of feeder roots. These systems are leu
able to make do wjth decreases In root pro-
ductivity r«ultlug from Imcct damage which
would be Insignificant in other regions
within the State of Florida.
.Aldrln Is overused on citrus to some extent
In that It Is unnecessarily utilized. Substan-
tial reduction In frop yields caused by lack
of treatment for tho Fuller Raie noetle 1«
relatively rare when the Industry Is consid-
ered on a whole.
Aa indicated In the Findings of Fact, cul-
tural practices offer a large potential for
disruption of pest problems caused by the
rose beetle and alternative Infectlr'.dnl follnr
sprays, most of which are already u.«od In the
Florida citrus program, some as often as 4 to
6 times a year, provide good Initial kill of the
adult weevil. The State of California docs not
recommend the use of aldrln to control the
rose beetle on lt» very substantial citrus
acreage and-a large Florida citrus grower or-
• ganlzatlon does not utilize It.
Once again, we need put the Issue with
respect to tho continued use of aldrln or
dleldrin on Florida citrus In perspective We
are presented herein In. these suspension
proceedings with the limited question of lu
continued use. during the time It voiild take
to complete proceedings relating to cancella-
tion of such chemicals. We are talking, it
seems to ns. of one split application of aldrln
or at most one annual application thereof.
It Is clear from the record that In view of
the limited area of possible need uid. In re-
ality, the limited number of orchards or
tre« Involved, tbo absence of aldrln during
the restricted p«rlod of eonaldoratlou wbulU
rtDHAl reOISTM, VOL 39. NO. JOJ—«IDAY, OCTOBER 18, 1974
-------
h. little. If any. affect upon the Florida
citrus Industry or the price for Its products.
Additionally, we see very little effect upon
the relatively «man number of possibly af-
fected growers. Cultural practices and foliar
Sprays are available to them as alternatives
:> oldrta or dleldrln." Further, we surmise
that existing stocks of these products, the
use thereof not being barred by the Adminis-
trator's August 2, 1974 notice of suspension,
may well be present In Florida to some ex-
tent. In short, we see no overriding benefit
or any great disruption from the nonavaila-
bility of aldrln or dleldrln for Florida citrus
during the- nex. growing season."
IX. Aldrln : . 1 predominantly dleldrln are
also used for seed treatment-or dressing on
many different types of seed: The record Is
not as complete with respect to the need for
these Insecticides In the treatment of some
seeds as distinguished from others or with
respect to seed treatment generally. Certain
generalizations can be made however.
Farmers will purchase seed after It has been
treated commercially, will treat the seed
themselves prior to planting, often as part
of a slurry or liquid mixture, or will add
the chemical directly to the seed In a planter
box at the time of planting. Commercial
treatm«nt of seed is more practical, tending
to provide a more even and effective distribu-
tion of relatively small quantities of Insecti-
cide, particularly In-contrast to individual
grower's applications by means of planter
boxes.
Dosages vary according to the type- of seed
treated and the seeding rate per acre. Under
normal conditions or circumstances, aldrln/
dleldrln U applied to seeds at the rate of
one-half ounce to ona ounce of the chemical
•per bushel or per 100 pounds of seed. The
cc»t or seed treatment with these Inseett-
' is relatively smalt and. In some In-
.63. is not passed on to the farmer.
Dleldrln has an effective life as a seed
dressing In soil of approximately 10 to 20
days. In warm or hot weather, seeds will
typically germinate In 4 to 8 days, but In
cool, damp weather germination may be de-
layed to a week or 10 days. Most of the seed
dressing alternatives advanced by respondent
are less persistent than dleldrln and provide
less of a margin of protection. Llndane ap-
pears to be an effective alternative but for
some criticism of a delay In germination of
the seed resulting from its use. This ap-
parently occurs if the seed has been treated
with llndane sometime, such as 3 weeks, be-
fore planting. A simple answer to this
criticism Is a planter box application of
Ilndane by the farmer at the time of plant-
ing. This process, of course, has some of the
disadvantages mentioned above.
Here too. however, we find no compelling
macroeconomle or mlcroeconomle reason
necessitating the use of aldrtn or dleldrln
see:' treatment during the period it will take
to complete the consolidated cancellation
proceedings. Several viable alternatives are
available.
°We have some hesitation or reservation
with respect to some possible disruption of
an Integrated pest management control sys-
•tem employed In Florida In the control.of
other Injects by the use of alternative foliar
sprays. We are not aware that this would
necessarily occur however. • •
"Two other weevils of lesser economic
consequence than the rose beetle were men-
tioned in the record. AU we have said with
respect to the Fuller Rose Beetle Is appllca-
b1- thereto. In addition the dlaprepes abbre-
is eradication program has available to
.Feral alternatives.
58
NOTICES
X. In the consolidated cancellation pro-
ceedings, the United States 'Department of
Agriculture defended the continued us* of
aldrln and dleldrln for certain uses la addi-
tion to those discussed above and It similarly
does so here. These Include such uses of ono
or -the other of these. Insecticides as oa
Puerto Slcon pineapples, sugarcane and
bananas, onions grown In the Tulelake TL*MI«
of Northern California, strawberries In Ore-
gon and Washington, .the Department's
quarantine program, cranberries and nursery
use.
The parties, that Is, in this connection.
USDA, respondent. Environmental Defense-
Fund, Inc. and the National Audubon So-
ciety, are. la effect, attemtping to place us
In the straltjacket of deciding the ultimata
Issues presented by the uses Involved In the
consolidated cancellation proceedings. We
refuse to be so restricted. For this reason
the briefs filed by these panics do not. In
great measure, really address the problem at
hand.
We have stated several times In this De-
cision that we are solely presented with the
continued use of aldrln/dleldrin during a
relatively limited time frame, the time it
will take to complete the cancellation pro-
ceedings. We do not Intend to consider mat-
ters beyond that period In this Decision.
In addition, the briefs of these parties with
respect to these uses do not deal with the
significance of the availability of heptacblor
and ehlordone In 1975. For the most part;
the parties attack the Issues as If hept'achlor
and chlordane do not exist. This is absurd
»nd we have no Intention of deciding the
i.uestlons posed herein -as if they do not
9 Oat because the ".real world" situation can-
not be Ignored.
Heptachlor and chlordane were not pro-
posed as alternatives by respondent and the
Environmental Defense Fund for the reasons
explained earlier. But, these chemicals are
here and are registered for many of the uses
defended by, USDA. In reality, USDA does not
challenge or question the efficacy of these
insecticides for most of their registered uses.
In fact, it recommends the use of chlordane
In Its regulatory and control programs and
"dleldrln is reserved for those limited uses)
involving soil surface treatments • • • where
chlordane will not render the required 100
percent control. « • • This reflects Depart-
mental policy requiring that chlordane be
substituted for dleldrln wherever possible." "
We need not analyze each of the USDA
defended uses and the need for aldrln or
dleldrln thereon. Heptachlor or chlordane
are registered and effective for such crops
or uses aa pineapples; greenhouse, nurseries
and nursery turf, onions, perhaps strawber-
ries, sugarcane and apparently bananas. Ad-
ditional substitutes are also available for
some of these and other uses. Also, there are
alternatives In the "registration pipeline"
which we surmise will receive priority.
It can also be stated with respect to the
uses Involved that we see no major food sup-
ply problem and certainly no macroeconomle
effect from the lack of aldrln or dleldrln. la
M Chlordane surface application is admit-
tedly effective for nurserymen where certi-
fication Is vnnecessary. The alleged need for
dleldrln surface application in limited cir-
cumstances for certification status for a 4
year period can. surely be solved by USDA
during the limited period Involvid herein-If
only by an additional application of chlor-
dane. This circumstance should not arise
often during the limited period and we are
certain that administrative adaptability ant*
ingenuity will easily solve this temporary
problem.
fact, the cranberry industry Is currently suf-
fering from a glut or oversupply. Also, we
Bee no substantial mlcroeconomle conse-
quence from the absence of these pesticides
during the limited period at Issue. Actually.
the absence of any Insecticides In some In-
stances will not have effect for some years.
•It must be realized In this connection that
aldrln or dieldrln are not used annually
with respect to most of these crops and the
. affected growers represent a small segment
of those Industries. For example, a minimum
of S year protection Is claimed with respect
to cranberries. In short, we believe that the.
growers Involved can manage for one season,
at most without aldrln or dleldrln but with
the alternatives at hand. As to some of these
growers, a different crop rotation Is available
If they are convinced that they cannot do
without aldrln or dl«ldrtn and cultural prac-
tices are available to negate or minimize the
absence thereof. For example, flooding of
cranberry bogs can eliminate the insect pest
or peats." to addition, to the extent existing
stocks of aldrln and dleldrln are available.
they may be used.
To summarize, there clearly does not
exist any compelling reason to make aldrln
or dleldrln Available. In 197S for the uses de-
fended by USDA. We are no^. hereby saying
that our conclusions with respect thereto
will be the same In the consolidated cancel-
lation proceedings when we assume that hep-
tachlor. and. perhaps, chlordane will once
again not be considered as alternatives. We
• con foresee, for example, a possible conclu-
sion calling Tor continued use of aldrln or
dleldrln at least for a limited period of time
.while alternatives are found. The record dem-
onstrates In most Instances Inaction or inade-
quate action In this regard.
In addition to all of the uses of aldrln
and dleldrln already discussed In these
Conclusions, they are uses for which no evi-
dence has been adduced with respect to the'
benefits to be derived from, or the need
for. continued, use of these Insecticides. It
Is patent, therefore, that there exists no
basis to Judge such benefits -and that. In
the context of these proceedings, no eco-
nomic, social or environmental benefit re-
sults from the continued use of these pesti-
cides for such purposes.
XI. Shell Chemical Company, In Its ob-
jections, alleges certain'procedural defects
or Irregularities In the Issuance of the No-
tice of Intention to Suspend by the Admin-
istrator August 2. 1974. which set In motion
the Institution of these consolidated sus-
pension proceedings. First, it contends that
such notice reversed a previous decisions
by a -former Administrator that aldrln/
dleldrln was not an "Imminent hazard" al-
legedly on the basis of the same evidence
before the present Administrator. USDA
similarly, makes this argument.
In his Determination and Order of De-
cember 7. 1973, In the consolidated aldrtn/
dleldrln cancellation proceedings the prior
Administrator, in deciding not to suspend
such insecticides stated. In part, that "the •
present evidence, confined to one strain of
mouse' Is tentative evidence of a 'risk,' but
not sufficient proof that aldrln/dielorta is
a carcinogen in "human beings. If unrebut-
ted, this evidence would be A caution sig-
nal as to long-term erposuv*, but does not
amount to a red light requiring imme-
diate elimination of aU dleldrln residue in
"There- are no registered alternative
chemicals for use on cranberries. But, very
fiw, if any, growers should critically need
the chemical in 1976. Only 300 acres were
treated In Massachusetts In 1972.
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 10, 1974
-------
59
the diet." The Administrator In his Au-
gust 1, 1974. Notice of Intention to Suspend
stated that "an Intense examination of the
relevant evidence over the past year • • •
brought to light certain previously unknown
facts, which have now been reviewed and
scientifically documented for the first time."
Such facts, clearly additional to those men-
tioned by the former Administrator In his
order of December 7, 1973 and his order of
March 18, 1971. In which he also failed to
suspend the 2 Insecticides Involved, are then
briefly set forth In the August 2, 1971 no-
tice of the Administrator. They clearly form
a new and additional boats supporting and,
perhaps, requiring the notice of Intention to
suspend. Furtner, certain factual assump-
tions or predictions by the former Admin-
istrator forming the basis for his decisions
not to suspend proved to be untrue. More-
over, the Administrator could also Issue
such a suspension on the basis of an exten-
sive re-evaluation of existing Information
"•which perhaps brought its full Impact to
. the attention of the experts for the ant
time." "Bell v. Goddard. supra." at p.' 181.
Shell Chemical .Company further contends
that the Notice of Intention to Suspend "Is
fatally defective In that, on information and
belief, It was based on Improper ex parts
communications with the Office of the Ad-
ministrator by parties In the cancellation
proceeding and/or their representatives or
agents and/or Congressmen and Senators
and their staffs."" These allegations have
not been established. In any event, they are
bottomed upon Shell's contention that the
suspension proceedings are but a phase or
port of.the cancellation proceedings. Such
la not the case. We agreed that the August 2,
1974 notice was based In large part upon evi-
dence adduced In the cancellation hearing.
This does not alter our conclusions. It would
be nonsensical to suggest that the Adminis-
trator could not consider such evidence In
making his determination to suspend or that
he need hold. In effect, a public hearing on
question of whether a suspension proceed-
ing should be Instituted which would In
. turn require a public hearing, which Shell
appears to contend herein.
The Administrator, In the Issuance of the
August 2, 1974 notice, was functioning In an
accusatory capacity in Instituting or initiat-
ing an action with the further responsibility
of ultimately determining the merits of the
"charges" so presented. While what was
formerly known as the Administrative Proce-
dure Act requires the separation of the ad-
Judlcatory and prosecutortal functions in an
agency (5 U.S.C. 864
-------
60
NOTICES
•ralso creates a- hazardous situation to.
public, that should be corrected Im-
mediately to prevent serious Injury, end
which cannot be permitted to continue dur-
ing cs» pendency of odmlnlscratlve proceed*
lags. AS "imminent hazard" may be de-
j'.ored at any .point In a chain of events
vhica say ultimately result in harm to tho
.public, is la =ot necessary that the final an*
'lelpoted "Injury actually have-occurred prior
to a determination that an "Imminent haz-
'ard" rxists.
Wo need not spin any sophisticated. In-
tricate ratlonala or argument in this connec-
tion,, as was dcae by respondent so well In
the brief flier1 herein, with which we basi-
cally agree, la short, suspension to to be-
based upon potential or likely Injury and
need not be baaed upon demonstrable Injury
or certainty of future public harm. Cf. "En-
vironmental Defense Fund v. Environmen-
tal Protection Agency." 466 P. 2d 628. 040
(D.C. Clr. 1973).
Briefly, we are talking of a cancer hazard
to man. We must remember. In this regard.
the characteristics of'a chemical carcinogen
such as aldrtn/dleldrln, that Is. the scien-
tific Inability to determine a safe or thresh-
old level for man. the fact that the chemicals
are carcinogenic at the lowest doses tested.
that residues of dleldrln In laboratory spe-
cies which developed cancer from dleldrln
approximate those residues in the American
population, the Irreverslbillty of the carcino-
genic effect once set In motion by the chemi-
cal carcinogen and the long latency period
during which the disease has actually set In
acd U developing but Is not 'yet manifest
Given these characteristics, the rials of Injury
or hana from the use of the pesticides Is pres-
ent during the pendency of the cancellation
proceedings even though the effects of such
'-'-try may not be manifested for many years
line. This Is precisely what the Admln-
_ 4tor had In mind In his March 18. 1971
policy statement set forth above, we believe.
tn short, the continued use-of aldrtn and
ileldrln even during the limited period with
arnlch we are concerned presents a signifi-
cant potential of an unreasonable risk of
cancer In the American public.
In this regard. Dr. Saffiottl said the follow-
ing: It Is Ukely that Dleldrln residues will
jontamlnato a large proportion of the food
tupply of the American people for many
years to come because of post usage of this
persistent pesticide. I am clearly not advo-
cating that a large proportion of the food
supply to the American people be eliminated
because of its presently unavoidable con-
tamination with Dleldrln. At the same time,
as a scientist, I am unable to conclude that
the continuing contamination of the envi-
ronment and our food supply with Dleldrln
will not produce in some of us the develop-
ment of cancers, as it has indeed been re-
peatedly shown to do so In other mam-
malians.
We fear that we have exhausted the reader
by this time and we know we have exhausted
ourselves In Uiulag this decision within the
Impossible time constraints Imposed by the
statute and the rules of practice. We merely
further say that the registrations of aldrin
and dleldrln properly Involved herein should
be suspended In order "to prevent an- Immi-
nent hazard during the time required for
cancellation" when "talcing Into account the
economic, social, and environmental costs
and benefits of the use of" these pesticides
by reason of all that has been already said
In this Decision. To hold otherwise la to
demand a state of knowledge with respect tc
cancer which we do not possess.
Nor does the recent decision in "Reserve
V'nlng v. United States." No. 74-1291 (6th
June 4, 1074) alter this conclusion as It
ostlngulshable from the case at hand.
While there are several grounds of distinc-
tion, such as the relative absence of asbestos
in tho population of Duluth. Minnesota, os
compared with the almost universal presence
of dleldrln In humans at significant levels.
and the possible difference between an "un-
reasonable risk to man" and "demonstrable
health hazard," the major distinction, we
believe, which'was recognized by the Court
In Reserve Mining, Is the question of burden
of proof. In that cast, the Court stated that
"Plaintiffs have failed to prove that a de-
monstrable health hazard exists. This failure.
• we hasten to add, is not reflective of any
weakness which It Is within their power to
cure, but rather, given the current state of
medical and scientific knowledge. Plaintiffs'
case la based only on medical hypothesis and
Is simply beyond proof." The Court there was
not dealing with a substance Intended to be
utilized as a poison. Under the Federal In-
secticide. Fungicide, and Rodentlclde Act. as
amended, the Congress, on the contrary.
properly placed the continuous burden of
proof of safety on the registrant."
Order. The registrations Issued under the
Federal Insecticide. Fungicide, and Rodentt-
tide Act. as amended, of the pesticides aldrin
and dleldrln Involved In these consolidated.
suspension proceedings are hereby sus-
pended."
Hnaxar L, PEBUUIT.
Chief Mmtnlitrattce lam Judge.
SUTZMBSB 20.1974.
[FXF.RA. Dockets Nos. 145 etc.]
Susu. CHTMtCAi. COMPACT, rr At.
cpnnoti or THE ADMBRSTBATOB, Ttrraan-
MSTTAS. raoTEcrxoy AOENCT, ott TUB SUS-
PENSION OF ALDSO-DZZUaXH
On August 2.1974. the Environmental Pro-
tection Agency (EPA) Issued a notice of in-
tent to suspend the registrations and pro-
hibit the production for use of all pesticide
products containing Aldrin. or Dleldrln. com-
pounds manufactured exclusively by the
Shell Chemical Company (Shell). This notice.
pursuant to section 8(c) of the Federal In-
secticide, Fungicide and Rodenttclde Act
(FIFAA).> resulted In several weeks of ex-
pedited hearings before Chief Administrative
Law Judge Herbert L. Perlman, the presiding
judge at the on-going Aldrtn-Dleldrin can-
cellation hearing which began In August of
1973.» On September 23. 1974. he- transmitted
to me his recommended decision. Including'
findings of fact and conclusions, which is
attached to this decision,
**We do not agree that this burden was
not continued In the 1973 amendments 'to
the act or Is altered tn a suspension pro-
ceeding, as contended by Shell Chemical
Company. Mention should also be made of
United States v. Swing Bros. Co.. Inc.. No.
73-1008 (7th Clr. August 28. 1974) where
the Court found that DDT and dleldrln
found In processed fish at levels above FDA
actionable limits were "food additives" under
•the Federal Food. Drug and Cosmetic Act.
We are uncertain of the significance of this
case to the Issue at hand.
a In order to avoid any ambiguity we have
not made any distinction with respect to
registrations of aldrin and dleldrln held by
registrants In these proceedings which we be-.
Hove may have already been suspended by
operation of law. that is. resulting from the
untimely filing of objections. (See footnote
3.)
'The Federal Insecticide. Fungicide and
Rodentlclde Act (FIPRA). 7 U.S.C. 135 et
seq., as amended by Pub. L. 92-516, 86 Stat,
973. October 21.1972. The regulatory author'
Ity under FIFRA was transferred from tht
Department of Agriculture to EPA by Re-
organization Order No. 3,1970.
A. Characteristics and Utes of Aldrtn-ZHat-
• drin.* Aldrin Is the common name of a chem-
ical compound containing not less than 95
percent of 1.8.0.10ai.ll-hexachlorc-i3-7. 6-
endo - 2.7.8 - exo - tetrocyclo |8Ja.l".0'-7]
dodec-45-dlene; It has been used as a con-
tact and stomach insecticide on a wide variety
of crops in diverse locations and situations
since Its Introduction In the United States In .
1948. As a pure compound, it ss an odorless,
white, crystalline solid; technical compounds
can be various shades of brown; It Is llpo-
phlllo. meaning that It h«a &Q affinity for
fatty body tissue, and is fat soluble. It de-
grades or metabolizes Into Dleldrln.
Dleldrln. a closely related manufactured
product as well as a metabolic degradation
product of Aldrin, is the common name
for a mfttftrtiU containing not loss than 8S
percent of 1.8.9.10.11.n-hexachloro-4.8-
exo - epo>y-2.3-7,6-endo-2.1-7.8-exo-tetracylo
[6.2.1.1.".0"1 dodee-9-ene. The pure com-
pound is also on odorless, white, crystalline
solid with a somewhat heavier molecular
weight than Aldrin. It also Is persistent, Is
more stable and toxlo than AHrtn, and is
llpophulo.
Aldrin and Dleldrln both are acutely tozle
to humans. Poisoning may occur by Ingestlon,
inhalation, or skin absorption, and serloud
symptoms may result from the ingestlon of
as little as one gram (1/28 of an ounce).
Symptoms of acute exposures Include renal
damage, ataxla, tremors, convulsions followed
by central nervous system depression, res-
• plratory failure and death. Chronic exposures
may result In damage to the Uver and other
body organs.
During the earlier yean of Its use In the
United States. Aldrin was almost entirely lim-
ited to applications on cotton, but In the
mld-lflSO's it was replaced by Dleldrln. By
1963. cotton constituted less than one per-
cent of total use of Aldrin. As of. 1971. soil
applications for corn accounted for 80 percent
of the total Aldrin usage. Other uses Included
termite control (14 percent), rice seed treat-
ment (3 percent), citrus oil use (1 percent).
and miscellaneous applications (2 percent)-.
Production of Aldrin In the first six months
of 1974 was 9.7 million pounds, compared to
approximately 8.7 million pounds produced
for the same period In 1973. • ' •
Dleldrln. because It is more persistent, re- •
placed Aldrin on 'cotton until the boll weevil
became resistant to both these chlorinated
Insecticides la the late 1950's and early 1960X
Dleldrln also was used on house files and
mosqultos. until they too became resistant,
and on a variety of other Insect pests. The use
of Dleldrln has declined from a ni«»m»nm of
about 3.8 minion pounds In 1956 to approxi-
mately 0.8 million pounds today. The most
'The transcript of the cancellation hear-
ing already exceeds 24,000 pages, not Includ-
ing many thousands of pages of the witnesses'
statements (which ere reported-separately)
and exhibits. The suspension hearing tran-
script approaches 4.000 pages '.n length, also
not including the lengthy statements by the
witnesses and exhibits, wh^h roughly are
the same length, as the transcripts, plus more
than one thousand pages of briefs, by the.
parties. •
' These two similar compounds have some-
what different uses; but because In the en-
vironment or in the body Aldrin quickly de-
grades to the more stable Dleldrln form, the
two terms win generally be used Interchange-
ably In this opinion.
fEDERAl REGISTER. VOL 39, NO. 303—FRIDAY. OCTOBER 18. 1974
-------
61
recent accurate figure* for Dleldrtn Indicate
that In 1971 approximately 44 percent was
used tor termites, 20 percent on fruit foaage,
14 percent for seed treatment. 13 percent on
vegetables, and 9 percent for miscellaneous
uses,0ncludlng tobacco and sweet potatoes.
Combined Aldr*" and Dleldrin consump-
tion, which In 1970 was 10.7 million pounds,
rose In 1971 to 12.3 million pounds. The- es-
timate fer 1973 is approximately 11 million
pounds.
B. Definition of cancellation and suspen-
sion. Aa will be discussed more fully later,
cancellation la warranted under the FIFRA
when there Is a "substantial question of
safety" concerning a pesticide. During the
period of the administrative review process,
which often lasts several years, the manu-
facture and distribution of the product con-
tinues unaffected—a fact which may con-
tribute to the protracted nature of many
cancellation proceedings.4
Suspension Is mandated when there Is an
"Imminent hazard** to *«**» or the environ-
ment. This may be declared at any stage of
the administrative review process, either
upon receipt of new evidence or after re-
evaluation of existing evidence.* The sus-
pension order, which resembles a prelimi-
nary Injunction,* Immediately halts the pro-
duction and distribution of the pesticide and
remains In effect until the cancellation hear-
ing Is completed and a final decision is made
by the Administrator of EPA.
0. History of the cue. For almost four
years, EPA has had under consideration the
issue of Aldrln-Dleldrin. On December 3,
1970. one day after the Agency formally came
into existence. It received a petition from
the Environmental Defense Fund (EOF) re-
questing the cancellation and Immediate
suspension of all uses of Aldrln-Dleldrlru As
a result, on March 18, 1971. the Administra-
tor of EPA issued a notice of cancellation
based upon a finding of a "substantial ques-
tion as to the safety" of Aldrm and Dleldrin.'
The Administrator also concluded, however.
that the evidence then available to him did
not demonstrate "an i™min«ti* hazard to the
public". He, therefore, declined to order a
suspension of the compounds pending com-
pletion of administrative review.
EDF promptly filed a petition In the
United States Court of Appeals for the Dis-
trict of 'Columbia to review the Administra-
tor's failure to suspend' the 'registrations.
• The Administrative Law Judge noted on
several occasions during the suspension hear-
ing that the cancellation proceeding on
Aldrln-Dleldrin was characterized by a fair
amount of .footdragglng. See, e.g.. Transcript
306.
•See Bell r. Ooddard, 386 P. 3d 177, 181
(7th Clr. I960), where an administrative ac-
tion was based on reanalysls "which perhaps
brought its full impact to the attention of
the experts for the first time."
• Environmental Defense Fund v. Environ-
mental Protection Agency, 456 P. 3d 538, 538
(C-AJ3.C. 1072) (hereafter EDPv. EPA).
Not* that In Nor-Am Agricultural Prod-
ucts. Inc. v. Hardln 436 F. 2d 1151 (7th Clr.
1970). cert, denied 402 U.S. 935 (1971), the
court held that a suspension order, since it
was not a final Agency decision, was not judi-
cially revlewable under FIFRA or the Admin-
istrative Procedure Act. The Nor-Am de-
cision was .criticized in dicta in Environ-
mental Defense Fund v. Ruckelshaus. 439
F. 2d 5«4. 691-682. (C-AJJ.C. 1971) [hereafter
EDF v. Ruckelahaus).
i Statement of the Reasons Underlying the
Decision on Cancellation and Suspension of
DDT, 2,4,5,-T, and Aldrtn and Dleldrtn.
March 18, 1971.
NOTICES
The Court's decision, issued on May 8, 1972.*
remanded the record to EPA for further con-
sideration of the Issue of suspension. In light
of the judicial Interpretation of the power of
suspension enunciated In the decision and
the March 28. 1972 report of the Aldrtn-
Dleldrln Scientific Advisory Committee. The
Court specifically directed EPA to examine
the nature and extent of evidence available
on the careinogenlclty of Aldrin-Dleldrln.
Following a review of the scientific evi-
dence requested by the Court, the Adminis-
trator reaffirmed the notices of cancellation
of nearly all Aldrin-Dleldrln uses on June 26.
1972.* The order also solicited public views
as to whether any of the cancelled uses also
should be suspended, with particular refer-
ence to those methods of application and
formulation presenting the most obvious
risk of widespread, unavoidable dissemina-
tion of the compounds.
Five months later, on December 7, 1972,
the Administrator announced that the regis-
trants of Aldrin-Dleldrln had agreed volun-
tarily to eliminate several of the more con-
troversial uses of the product. Furthermore,
pursuant to the May 6,1972 Court of Appeals
order, the Administrator announced that he
had further examined the Issue of suspen-
sion and determined that the available evi-
dence still did not justify a finding of Im-
minent hazard* *
The cancellation hearing on the risks and
benefits of Aldrln-Dleldrin began on Au-
gust 7, 1973 and was still in progress a year
later when, on August 2. 1974, the Agency
Issued Its notice of Intention to suspend. On
August 7. 1974. a presiding officer, Chief Ad-
ministrative Law Judge Herbert L. Perlman,
was appointed for the suspension hearing,
which commenced on August 14, 1974 and
was to last no longer than 16 hearing days.
The hearing closed on September 12, 1974.
the recommended findings and conclusions
of Administrative Law Judge Perlman were
delivered to me on September 23. 1974. and
on September 24, the parties submitted ex-
ceptions to Judge Perlman's recommended
decision,
D. latuca and controversies. The cancella-
tion hearing, which is expected to continue
for an indefinite period, has dealt with a
broad range of questions concerning Aldrln-
Dleldrln's alleged deleterious effects on the
environment and on human beings." in con-
trast, the suspension hearing has been con-
cerned solely with whether Aldrin-Dleldrln
• EDP V. EPA. 466 F. 2d 528 (CAJJ.C. 1972).
• The Administrator exempted those regis-
tered uses Involving subsurface ground In-
sertions for termite control, mothproofing
processes using a closed system, and the dip-
ping of roots or tops of nonfood plants.
. a Testimony on environmental (non-hu-
man health) effects of Aldrin-Dleldrln has
been presented in the cancellation hearing
relating to Dleldrln residues in marine and
freshwater aquatic organisms, birds, land
tmmmnln. and soil invertebrates. Because of
its persistence and ubiquitous presence ln>
nature. It Is regarded as a particularly
troublesome potential threat to the environ-
ment. Considerable testimony has been pro-
vided relating to Its acute and chronic tox-
Iclty, transport mechanisms, bloaceumula-
tlon. and blomagnlflcation characteristics.
resistance of certain species, and various ef-
fects on the respiratory and reproductive
mechanisms of fish and terrestrial life. Theso
environmental factors, as well as other
human health hazards, although not the
subject of this suspension proceeding, will
b« carefully considered In the final Agency
decision on cancellation.
poses a cancer hazard to human beings, and
whether It provides countervailing benefits.
During the hearing, counsel for both EPA
and Shell characterized the Issues as "cancer
and corn." although Judge Perlman correctly
pointed out that the benefits also Included a
number of other crop uses." Nevertheless.
In the suspension hearing record, statements
of the parties indicate that the major con-
troversy, in fact, may be narrower than "can-
cer and com." Counsel for Shell declared at
the beginning of the bearing: "Tour Honor,
In our view the Issue Is really cancer."u
Even the presiding. officer, who properly
sought to Insure that all relevant Issues were
addressed, stated explicitly, "I mean there Is
no fooling around, the major Issue Is can-
cer." a
E. Legal background. The Administrator
la authorized by section 8(c) (1) of FIFRA "
to suspend Immediately the registration of
a pesticide pending the outcome of final can-
cellation proceedings if he determines such
action Is necessary to prevent an Imminent
hazard."
• • • the function of the suspension de-
cision la to make a preliminary assessment
of evidence and probabilities, not an .ulti-
mate resolution of difficult Issues.11
and
The suspension order thus operates to af-
ford Interim relief during the course of the
lengthy administrative proceedings.11
In accordance with the proposition that a
suspension order Is not a final determination
on the merits of cancellation, but rather a
temporary decision, the Agency has token
the position that it has a continuing re-
sponsibility to review suspension decisions.
In his order of March 18. 1971."1 then-Ad-
n counsel for Shell Chemical Company
stated, for. example, that "corn, that Is really
all we care about." Transcript. 87. See also
Transcript 123,294.
a Transcript 87.
i» Transcript 92.
"7U.3.C. 136d(c)l.
u The Department of Agriculture has eon-
tended from the beginning of the suspension
hearing that there has been an unlawful
commingling of "prosecutlve, adjudlcatlve,
and judicial functions required to be per-
formed under FTFRA." (See Transcript, p.
37.) This Is an Interesting assertion because
prior to 1970 the functions of FIFRA, In-
cluding suspension, were performed by the
Secretary of Agriculture Section 6(c) of
FIFRA clearly states that the Administrator
shall Issue the notice of Intent to suspend
and, later, make 'the suspension decision.
Shell also has repeatedly alleged that un-
lawful ex parts consultations gave rise to the
2 August 1974 Notice of Intention to Sus-
pend. I am completely convinced that any
and all consultations between me and my
staff which led to the decision to initiate
the suspension proceeding were entirely
proper and In accordance with due process
requirements, administrative law and prac-
tice, and fundamental notions of fair play
la the conduct of Agency adjudicator? pro-
ceedings and therefore find the assertions of
USDA and Shell to be unfounded.
The function of a suspension order Is not
to reach a definitive decision on the registra-
tion of a pesticide, but to grant temporary,
interim relief. The Circuit Court of Appeals
for the District of Columbia twice has stated
this view:
a EDF v. EPA, 465 Fid at 537.
"EDP v. Ruekelshaus, 436 F.2d at 589.
" 18 March 1971 Order: Reasons Underly-
ing the Registration Decisions Including
Products Containing DDT, 2,4,5-T, Aldrtn
and Dleldrtn, p. 12.
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 18. 1974
-------
..trator William D. RuckeUhaua stated
that the Agency would be prepared to reeval-
uate the question of suspension at any later
stage In the administrative proceedings. In
Its most recent suspension order. In this
proceeding, the Agency stated "The Admlnls-
; -stive process Is a continuing one. and colls
for continuing re-examination at significant
Junctures." '•
The Administrator, as noted above, mar
. suspend when he finds that an "Imminent
hazard" would result during the pendency of
cancellation proceedings. Section 2(1) of
FIFRA » d*caes the term "Imminent hazard"
as "a situation which exists when the con-
tinued us« c a pesticide during the time
required for cancellation proceedings would
be likely to result In unreasonable adverse
effects on the environment." "Unreasonable
adverse effect on the environment" Is defined
by section 2(bb) of FIFRA " as "any unrea-
sonable risk to man or the environment, talc-
ing Into account the economic, social, and
environmental coats and benefits of the use
of any pesticide."
The Circuit Court of Appeals for the Dis-
trict of Columbia has amplified the statutory
definition of imminent hazard: "But we
must caution against any approach to the
term •imminent hazard,' used In the statute,
that restricts it to a concept of crises." a
In another case, the Court declared: The
[Secretary of Agriculture) has concluded that
the most Important element of an "Imminent
hazard to the public" is a serious threat to
public health, that a hazard may bo im-
minent even If its Impact will not be appar-
ent for many years and that the public pro-
tected by the suspension provision Includes
fish and wildlife. The Interpretations all seem
Uent with the statutory language and
se.=>
Addition, the Administrator, In his order
01 March 18. 1971 specifying the criteria for
determining an "imminent hazard," stated
explicitly that suspension was warranted to'
prevent actions "which cannot be permitted
to continue during the pcndence of adminis-
trative proceedings. Imminent hazard may
be declared at any point In the- chain of
events which may ultimately result In harm
to the public." =«
In a suspension proceeding, unlike a can-
cellation action. EPA Is not required to bal-
ance possible benefits against the environ-
mental and health risks of pesticide usage.
The Court of Appeals has considered this ex-
ercise of administrative discretion by EPA
and concluded: "We do not say there Is an
absolute need for analysis of benefits." =
We are not clear that the FIPRA requires
separate analysis of benefits at the suspen-
sion stage. We ore clear that the statute em-
powers the Administrator to take account of
benefits or their absence as affecting 1m-
mlnency of hazard.?*
The Agency traditionally has considered
benefits as well as risks, however, and in my
opinion, should continue to do so. The
recommended decision of the Administrative
62
NOTICES
Law Judge contains a lengthy discussion of
the crop uses of Aldrin-Dleldrin. with their
effects and alternatives. Benefits and alterna-
tives are discussed In Part HI of this
opinion."
In deciding to suspend because of a sub-
stantial risk, of cancer In man. the Admin-
istrator Is obliged to follow expressed Con-
gressional policy of keeping carcinogenic
chemicals out of the food supply. One Court
haa pointed out that although pesticides are
not "food additives" under the Delaney
Amendment, 31 U.3.C. 348(c) (3) (A), the
Amendment does however, indicate the mag-
nitude of Congressional concern about the
hazards created by carcinogenic chemicals,
and places a heavy burden on any adminis-
trative officer to explain the basis for his deci-
sion to permit the continued use of a chemi-
cal known to produce cancer In experimental
animals.2*
The Seventh Circuit has recently held that
pesticide residues In processed foods were-
"food additives" within the meaning of other
sections of the Food. Drug and Cosmetic Act,
21 O.3.C. 321(s).» But. since the Delaney
Amendment does prohibit the setting of sofa
levels/tolerances of carcinogenic food addi-
tives, and since Aldrln-Dleldrln U present as.
residue in processed foods, the Administrator
has a particular burden to explain a, basis
for a decision permitting continued use of a
chemical known to be a carcinogenic In lab-
oratory animals.
H. THE ISSUE OF THE CASCTKOCZHICTrr Or
" Order of August 2. 1974, at p. 4, quoting
from EDP v. EPA. 465 F.2d 828 (1972).
=>7US.C. 136(1).
='7U.S.C. 136 (bb».
"ED? v. EPA. 465 F. 2d at 5-10.
a EDr" v. Ruckelshaus. 439 F. 3d at 597.
« Ord-r of ia March 1971. supra, p. 6.
51 EDc1 r. EPA. -165 F. 2d at 540.
* EOF v. EPA. 465 P. 2d at 538. If an analysis
of'benefits Is undertaken, the Courts have
!>•—'rte-J that "greater .weight should be ac-
\ line value of a pesticide for the con-
r disease, and less weight should be
.ded Its value for protection of a com-
mercial crop." EOF v. Ruckelshaus, 439 F. 2d
at 594.
A. General theories of carcinogenicity.
Ussplte tha manpower and resources which
have been devoted over several decades to
the study of cancer, scientists are stm for
from agreement on the causes, nature, and
even definition of cancer. In such aa Inquiry,
where we are acting on the frontiers of
knowledge," we must rely on the best avail-
able evidence and interpretations and be
prepared to modify our views if future scien-
tific advances show we were in error.
A carcinogenic substance, in our opinion.
la one which Increases the incidence of
benign or malignant tumors In exposed anl-
• mals, decreases the latency period between
exposure and onset of the tumor, or results
In unusual tumors."
The once-significant distinction between
tumors and cancers, or between tumorogenlc
and carcinogenic substances, has lost much
of Its validity with the Increasing evidence
that many tumors can develop into cancers.
Thus, for purposes of carclnogenlclty testing,
they should be considered synonymous.51
"It is, nevertheless, clear from the EPA
Rules of Practice 40 CJ.R. J 164.121 (g). and
from'the case law, that the burden of proof
In establishing the safety of a pesticide prod-
uct in both cancellation and suspension pro-
ceedings remains at all times with the
registrant. EOF v. EPA.-465 F.2d 528. 532 (D.C.
Cir. 1872); Neodane Company. Inc. v. En-
vironmental Protection Agency, 470 F.2d 194
(8th Cir. 1972); Stearns Electric Paste Co. 7.
Environmental Protection Agency, 439 F.2d
584. 593. n. 34 (C.A.D.C. 1971). See also Ad-
ministrator's Order of 18 March 1971.
» EOF v. Ruckeishaus. 439 F.2d at 596, note
''United States v. Vita Food Products of
Illinois. Inc.. No. 73-1008 (7th Cir. 28 August
1974).
a Industrial Union Department. AFL-CIO
v. Hodgson. 499 FJ2d 467. 474 (CJUD.C. 1974).
31 The International Association for Ra-
seorch on Cancer (IARC) defines cancer a
the Induction or enhancement of a neoplasm.
International Association for Research on
Cancer Report, p. 9.
*> IARC Report, p. 10.
Similarly, the distinction between benign and
malignant tumors, while Important to the
Individual host animal. Is not a rellablo In-
dicator of carclnogenlclty. for "In the think-
ing of moat experimentalists, the Induction
of a benign tumor Is merely n stage la a sub-
sequent occurrence of a malignancy." "
This does not mean that some cate-
gorization Is not useful to researchers.
One recognized authority has set forth
five stages of cancer development: (l) No
hyperplastlc lesions, (2) hyperplasla, (3)
hyperplastlc nodules, (4) small carci-
noma (less than 5 mm), (5) large car-
cinoma." If, for example, a pathology
study found stage-four carcinoma In the
exposed animals and the same number
of stage-two lesions In the controls, the
results would be distorted If the re-
searcher thereby concluded that the sus-
pected carcinogen had no effect. Such
differentiation is not critical to this
opinion, however, except possibly In the
later analysis of certain Aldxln-Dleldrln
tests on rats.
We have long known that cancer may
be induced by chemicals, radiation, and
even variations In the environment, but
we are still not certain of the various
mechanisms Involved. Although four
basic models have been proposed," we do'
not have a unified model explaining the
relationship between the dose and the
subsequent cancerous'response.
These theoretical concepts have a bear-
Ing on the Aldrin-Dleldrln issue, par-
ticularly as to the Question of the exist-
ence, OP non-existence, of a threshold
level of carcinogenic effect: A "no-effect"
level theoretically may exist, but It has
not been conclusively demonstrated.
and—based on the record In this case—
we certainly do not know the "no-effect"
level for Aldrin-Dieldrln. The lowest dose
tested (0.1 ppm) still produced signifi-
cant tumors In experimental animals."
I therefore agree with the finding of the '
Administrative Law Judge that "It is Im-
possible to establish a 'safe' level of ex-
posure of Aldrin-Dieldrln to man." *
" World Health Organization Reports of
Cancer, EPA Ex. 40B.
"Statement of Melvln D. Reuber. MJ3
EPA Ex. 42, p. 10.
= These models are the following: (1) Tho
"one-hit" theory, derived from extensive re-
search on atomic radiation, which holds that
a carcinogenic effect may result from a single
infortultous "hit" on a single cell by some-
form of energy, such as a chemical. (2) The
so-called loglt model, derived from chemlcM
kinetics, that there Is a slow Increase In re-
sponse as the dose Increases until anally the
effect levels off when the limited number of
chemical bonding sites are occupied. (3) Tho
so-called theory of metabolic overload, which
assumes that there Is a threshold level In each
Individual, and only when that Is exceeded
will cancer develop. (4) Tho theory that
everyone has a dldereut sensitivity to car-
cinogenic stimuli, and that as a statistical
assumption the distribution takes the form
of a bell-shaped curve. It may well be that
more than one theory Is correct, depending
on many variables, but that Is beyond tlia
scope of this opinion. In any cose, these four
i..odels produce very similar results wltliln
the 2-98 percent range.
" Shell Ex. S-3A. Tables Id & 17.
** Recommended Decision nnd Findings of
Fact and Law. Finding No. 25, p. 26.
FEDERAL RgGISTcll. VQL 37, NO. 203—FRIDAY, OCTO3ER 18. 1974
-------
63
NOTICES
Contrary to a wide-spread belief. It la not
true, that all substances are carcinogenic tf
introduced In sufficiently large <*.«•**, Cor*
clnogenletty la a relatively rare phenomenon
exhibited by only a few of the many hun-
dreds of thousand! of chemicals.** Trig** QQ*^
are administered In »n«m*i testa, not because
the researchen seek to correlate "»'«"»' re-
sponse levela to humans, but because with a
limited number of animals this methodology
Is necessary to determine groan effects.* Con-
sequently, a substance that will Induce
cancer In experimental »i compounds.
WhUe dogs have been employed for tests of
cardnogenlcity, with noteworthy success m
selected eases (bladder cardnogenlcity of
aromatic amines), the requirement of life-
time feeding makes this species too expen-
sive, in terms of time and funds, to be em-
ployed routinely. EPA Ex. 40P.
<• Although during the tn-m-ing shen argued
that mice were an Inappropriate test species,
one of the reasons for the relative, shortage of
Shell data on other species is that Shell pre-
• f erred to use mice in its own cancer experi-
ments.
« Shea Ex. 12. pp. 30-33.
M in tny ease, three of the four remaining
mice strains were especially resistant to
spontaneous llvar lesions (these were the.
strains used by Bhell) and the fourth had
only average susceptibility. This will be dis-
used in more detafl In the next section.
•EPAEx.46,p. ll.
pertinents are designed to compare the effects
of one variable—the chemical—on exposed
animals otherwise subject to the same con-
ditions.*
Some witnesses also suggested that car-
cinogens can be species-specific—that is, a
chemical substance might affect mice but
not any other species, including "itm This is
theoretically possible. But of the thousands
of compounds tested, the record Indicates
that this effect has been suggested for only
one of them.'1 and even this single exception
has been seriously challenged.** I therefore
If carcinogens are not species-specific. It
logically folliws that the demonstration of
carcinogenic effect In more than one species
Is not absolutely necessary for a amting of
carclnogenlclty.*
Most carcinogens are also not organ-
specific. In a survey by Dr. Tomatis of M
compounds known to produce liver tumors
in mice, 40 also induced tumors in a variety
of other organs.0 Furthermore, chemically-
Induced tumors in one species need not ap-
pear In the same organ In another species.0
Thus, a carcinogen which Induces liver tu-
mors in mice might, for example, produce
mammary cancers in rats and lung tumors
in men.
a Careinogenlcity of aldrtn-dielirtn in
mice. There- is no dispute that Aldrtn-Dleldrln
significantly Increases the Incidence of liver
tumors In five different strains of mice-. There
Is overwhelming scientific data supporting
this fact, and the registrants have now con-
ceded this point: The main result from the
Initial analysis wes that in all Studies there
was a highly significant dose related Increase
In the liver tumors.**
The IARC has concluded that: Dteldrtn
was tested by the oral route only in mice and
rats. The hepatocarctnogenldty of Dleldrtn
In the mouse was demonstrated and con-
firmed In several »H«««HMH»~*^ «m< some of
the liver faimom were found to metastoslze.
A dose-response effect has been demonstrated
in both sexes with an Increased i™»-M«m^ in
toe females at the lowest dose tested, 0.1
ppm in the diet.**
* EPA Ex. 8-11.
0 The exception, according to Shell, is Pne-
nobarbitone, which is supposedly carcino-
genic In mice, but not in man. Shell Ex. 14,
based on Dr. Qemmesen's study of epileptics.
Arsenic may have the obverse effect, but the
mice tests are still not conclusive. See Perl-
man. Becommended Decision, p. 41.
* Dr. Schneidennon has been quite critical
of the Clemmesen study and **>"*^ndn that a
mathematical re-analysis of his results is
•consistent with the possibility that the antl-
convulsanta which the epileptics received in-
creased the risk of liver cancer, perhaps two
or three fold." EPA Ex. 10, p. 9.
will rely on the conclusion of such organiza-
tions as the International Association for
Research on Cancer, which have rejected
species-specificity as unsubstantiated.*
•EPA Ex. 40-H. Even if apedes-spedflclty
does exist, it t»SIieUEx.8-3A.p.3.
• EPA Ex. 8-17, ppJO-M.
Shell's own test results confirm the above
conclusions. In exposed groups, all three
strains of mice In the seven testa had a high
Increase In the Incidence of liver tumors. The
first two tests (Study 1 and Study 2.1) are
the most meaningful because the test popu-
lations were much larger than In the other
tests and the dose levels ranged low enough
so that acutely toxic effects did not Interfere
with the development of slower tumors. The
mice tested were also from inbred, outbred,
and hybrid strains.10
The teat results show that the Increaiie 111
the Incidence of tumors was dose-related/-*
although at doses above 10 ppm this relation-
ship was diminished because of Interference
by acutely toxic effects. At the' lowest dose
level tested, 0.1 ppm. there was on Increase
In benign and i~ii;pnt«t tumors." Those
that did develop had a greater tendency to
spread to other sites in the body and espe-
cially to the lungs."
Aldrtn-Dleldrln shortened the lateucy pe-
riod In the development of tumors In both
sexes.** In one test measuring the effects of
limited exposure, the compound Increased
the Incidence of tumors after exposures aa
short as two weeks; the effects were even
more pronounced after one mouth of
exposure.'
The Incidence of malignant liver lumors
was statistically significant In almost every
test Shell performed.*1 This elevated incidence
of malignancy Is particularly Important be-
cause these strains of mice were especially
resistant to malignant uver tumors. The In-
cidence of malignancy In female controls was
almost nil and In males it woe quite low.
Exposure to Aldrln-Dleldrln and DDT ap-
parently hassynergistlc effect on the develop-
ment of tumors. Mice fed 60 ppm DDT had
some Increased Incidence of tumors. How-
ever, when mice received a diet of 6 ppm
Aldrln-Dleldrln In addition to 5O ppm DDT.
the incidence of tumors Increased sharply:
Males had 4 times and females 8 tunes as
many malignant tumors as those exposed
only to DDT. Dr. Reutoer has concluded.
It certainly Is clear from these observa-
tions that Dleldrtn and DDT have additive
effects when. It comes to cardnogenlcity.
Further, the evidence Indicates that Dleldrin
is primarily responsible for this Important
effect. Using the SO ppm group as the con-
trols the carcinogenic effect of the combined
"Study 1's population was over 1000 with
dose levels of J. 1. and 10 ppm. Study 3.1
had a population of 400 and five dose levels
of 125, 2A B.O, 10 and 20 ppm. Note that
Dr. Nathan Mantel has testified that Shell's
method of analysis Is on adoption of one he
developed, and he criticizes Shell for falling
to apply his method correctly. He states
that their analysis is insensitive to patterns
and consistencies and the effects of compet-
ing taridty at high dose levels. Because of
Its shortcomings. Dr. Mantel feels Shell's
analysis la "almost guaranteed to give non-
(Ugnlflrannn for even the strongest carcino-
gen". EPA Ex. 3-31. pp. 3-9.
• SheU Ex. S-3A. Table Data 1, Table Data
3; Transcript 986.
« Shell Ex-'S-OA, Table Data 1.
• Shell Ex. S-3A. Table Data 1, Table Data
•EPA Br. 80, pp. 12.13: EPA Bx. S-l. p. 9.
• EPA BX. 43-S, Table S.
fDEtAL KGISTOV VOL 39. NO. 203—R10AY. OCTOBEB 18, 1974
-------
!r.5 of Dleldrtn and DDT Is very highly
significant by statistical analysis.1"
Tin World Health Organization has recog-
nlzvfi that'In exposed mice there is an In-
creased risk that liver tumors will spread to
the 1^333.° Shell's test results have eon-
limed this, for at least two of their experi-
ments demonstrate a statistically significant
increase of lung tumors for both sexes. Some
'acrease In lung tumors was observed in al-
• most all their testa. Dr. Gross has testified
tint the results of the first study:
• • • leave little room for doubt that
Dleldrin at either 0.1 ppm or both the 0.1
and I ppm Ie7»ls r*"i elevate the Incidence
of tumors a* sites other than the liver
(particularly ;a the lung) and that this
elevation is highly significant In either males
or. females or In both sexes.**
D. Carcinogenic effects on rats. Bats have
been used less frequently than mice as test
populations. The quality of the tests has
varied widely, and the results have not been
uniform. For those reasons the Administra-
tive -Lav Judge concluded.
We are hesitantly unwilling at this time to
find that Dleldrln is conclusively a car-
cinogen in the rat although there are indica-
tions "«** tnls is so especially when the
chemical Is tested at the lower dosages • • •
we are certain, nevertheless that the findings
In the rat cannot be described as negative.
(Emphasis In original.) «
This caution la warranted by the serious
deficiencies In the available rat tests. Bow-
ever, it Is my conclusion, following an in-
tensive re-«xainluatlon of the statistics and
testimony presented in the recent hearing.
, that ' lucre is a strong probability that
Aldrin-Oieidrln is a carcinogen la rats- as
veil Of» mice.'"
.The tvo series of testa conducted by the
T ' and Dni$ Administration (FDA) are.
.1 Tor determining the effects of Aldrln-
Du..OriQ on rats. Exposed rats had a mark-
edly, increased Incidence of liver and other
tumors. which was especially noteworthy be-
cause the tested strains had a low rate of
natural liver tumors.
The raia doubled for rats exposed to
Aldrln and Increased by one-third for those
exposed to Dleldrln. A no-effect level was not
observed. The liver to body weight ratio lu-
creswd. and at high doses there were seri-
ous enlargements of the liver. After six
months, a dose-related decrease hi survival
rates was observed. In over 90 percent of the
01 See Shell Ex. 3-A Tables 16 and 17. For
example, the Shell Study 2.2 shows a slg-
nlfte-.uit Increase with 1.321 of the controls
and ;o.5o " of the. exposed mice developing
znaii^nact tumors- This has a very low
r'.unce probability of .000000048. Almost
turee time;* as mauy of the treated mice hod
benign or malignant tumors as did the con-
trols (EPA Ex. S-l, p. 18). However. Shell
contends that even though the Increase In
'.-.in? tiunors U very lilgh. this Increase is
incidental to the development of liver tumors
r-ncl therefore, they reason. 16 cannot be
proven to be caused by Aldrtu-Dleldrin.
•'-EPA Ex. 42. p. 20. -
u Shell Ex. S-4. p. 20.
'-EPA Ex. S-9. p. 29. Dr. Gross found
significant Increases In lung tumors, regard-
less of whether liver tumors were present,
a:;cl a decrease In the latency period. Over
three time as many (77.8%) expowd females
developed lung tumors within two weeks as
d:d th» control females. (EPA Ex. S-l. p. 9.)
c Rtrcoir.ir.ended Decision, pp. 56-07.
*Tlu> determination that Aldrln-Dleldrm
Is probably carcinogenic in two species Is
A-' -uU but not absolutely essential, to a
f g. of imminent hazard, as the data on
Hi... is su2clently strong to Justify a find-
In; of carcinogenic risk.
64
NOTICES
rats dying at high dose levels, lesions were
present."
Alter reviewing the FDA tissue slides, Or.
Reuber confirmed the Increase In tumors.
He round that at the low dose levels (13-10
ppm) there was a low Incidence of liver
tumors but on Increased Incidence of tumors
la other organs. At higher doses, there was
a- higher Incidence of liver tumors. This In-
cidence of tumors more than doubled at both
low and high dose levels. WbUo no liver
tumors were observed. In controls. 18% of
the rats at high dose levels had liver tumors."
These results are confirmed by Shell's own
test results, which show that almost twice
as many exposed rats had tumors and the
liver to bod; weight ratio among female rats
.increased at low doses.*
E. Test* on other species. Aldrln-Dleldrln
has also been tested In species other than
the mouse or the rat. Almost all these tests
have been on dogs and monkeys and are not
very useful, due to their small populations
and test durations shorter than the cancer
latency period.
There have been three dog experiments.
The populations have been small, ranging
from 1 to 3 »Ti«mt»« per dose leveh with ft
duration not exceeding two years. In spite
of these obvious test inadequacies. After two
years of exposure dogs had diffuse hyper-
plasla of the liver which "was such that
over a period of several years the dogs could
have developed carcinoma of the liver." n In
commenting on the weaknesses of the dog
testa. Dr. Saffiottt has stated that an accept-
able test:
• • • would require a duration of at
I ;ast ten years to come close to the age at
which tumors could begin to be found. For
example, benzldlne. a potent carcinogen for
the urinary bladder In man as well as dogs.
took about seven years to produce Its first
tumor In dogs. The number of anlmalii
needed for statistical evaluation of tumor
Incidences In treated and control groups la
dependent on mathematical and. not zoolog-
ical criteria, so that there is no reason to
accept experiments on groups of one or two
or five dogs any more than there Is to accept
experiments In one or two or five mice. In
conclusion, these dog studies are completely
and utterly Inadequate as carelnogenesls testa
and should be totally discarded In the con-
sideration of the carcinogenic response to
Dleldrln.™
There has been only one monkey test.
which had five monkeys at each of five dose.
levels, and six controls. The test duration
was about six years. During that time there
was some evidence of mlcroenzyme Induction,
but there were no observations made on
tumors.11 .
Dr. Safflottt has stated that: However, as
In the case of dog studies, the number of
animals used and the duration of the test
for only approximately one-fourth of the ex-
pected llfespan of this species, make this
study totally inadequate as a carclnogenesia
test.9
F. Extrapolation of animal data to man.
The ultimate Issue In this suspension pro-
ceeding is whether Aldrln-Dleldrln is car-
cinogenic In «""«- Because man's response
" EPA Ex. 33.
* EPA Ex. 42. At low doses female rats had
an especially high Incidence of liver tumors.
At high doses the Incidence of liver tumors
was'not as pronounced as should be expected
because the rats died from the toxic effects
before tumors could fully develop.
« Shell Ex. 8-13.
» EPA EX. 42, p. 38.
« EPA Ex. 40. D. 33.
"Transcript, 1082.
a EPA Ex. 40. p. 33.
the finding that a substance Is carcinogenic
In experimental animals indicates that it
to carcinogens Is similar to that of rodents.
poses a similar risk to man. Dr. Heston has
testified:
Knowing this, and knowing the general
biological similarity of mice and other mam-
tnaiinn species, including man. we can rea-
sonably expect that in a population of human
beings exposed to Aldrin-Dleldrln. cancer
of some kind will occur in some individuals.
and these Individuals- will not have been
afflicted in the -absence of these compounds
• • • The human population Is so much more
genetically diverse than any laboratory ani-
mals. that if a chemical has been shown to
be carcinogenic by a significant induction In
any laboratory strain of mammal, we can
reasonably expect that at least certain human
beings would also respond to the chemical
by developing some kind of neoplasm."
The strongest position for the- registrant
was taken by Dr. Don Stevenson, Director of
Shell's TunstaU Laboratory, who testified
that evidence of human carcinogeniclty is
only sufficient when five criteria) are met:
1. The exposed ""'•*««'« experience a higher
3. Tumors develop in mare- than one
species.
3. The development of these tumors can
be proven to be compound-related.
4. Th» animal has proven to be an ade-
quate model for extrapolating to man.
5. Human data Is available-, proving at least
one incidence of cancer that la compound-
related."
It Is no exaggeration to say that Dr. Steven-
son's demands are practically Impossible
to meet.1* Our knowledge of cancer mech-
anisms Is still Imperfect and 'it may take
many years before we understand the mech-
anisms with certainty. Furthermore, epl-
demlologlcal studies are difficult or Im-
possible to conduct on the effects of Aldrln-
Dleldrln.
It is the carcinogenic effect of Aldrtn-
Dleldrln. not the mechanism that concerns
us here. The evidence la conclusive that
Aldrln-Dleldrln is carcinogenic in mice.- It
has produced statistically significant com-
pound-related benign and malignant tumors
In the livers of five different strains of mice.
It also significantly Increases the Incidence
of lung tumors. This evidence of carclno-
gonldty Is supported by additional, although
not definitive, evidence that Aldrln-Dleldrln
has Increased the incidence of tumors In rats.
Dr. Upton, a recognized cancer expert, has
testified:
In safety testing of carcinogens today we
are concerned with one question:
Does exposure to the test agent result in
a significant Induction of tumors In ex-
posed populations as compared to controls?
If so, then the test agent has elicited a car-
cinogenic response and must therefore be
considered potentially hazardous to human
health. Whether the agent actually Is a sine
qua non of the observed response or merely
enhances a virus or some other factor found '
in the host animal is Irrelevant unless and
until we know that similar factors are not
also found in man. T/ntU we have such
knowledge, we have no basis on which to
matce distinctions between "carcinogens'*
« EPA Ex. S-ll. 8 & 7.
n Transcript 817-335.
m Dr. Stevenson's position on the necessity
of proof for two species is particularly inter-
esting, since as Director of Shell's Laboratory.
ho feels that it is no longer fruitful to do
r search on rats. Furthermore, in spite of
Shell's strong position on the necessity for
human data, the Registrant Is no longer
studying Aldrln or Dleldrin's effects on man.
FEDERAL REGISTER, VOL. 39, NO. 203—FRIDAY, OCTOBER 18. 1974
-------
65
NOTICES
and "co-carcinogens" and "causative agents"
versus "enhancing agents".
Given tola lack of knowledge concerning
mechanisms, I believe that a carcinogenic
reaction in any species of test *nim*i must
be considered sufficient to describe the test
compound as a carcinogen and so a threat
to human health. I consider that a similar
reaction in a second mammalian species la
a confirmation at the carcinogenlclty of the
test agent but it Is not necessary before a
finrtir.g Of carclnogeniGlty and threat to hu-
man health can be made; and negative re-
sults in a second or even third species of
test «n«mni do not In my mind establish
that the test agent Is not a threat for hu-
man beings. Given the variation in human
susceptibility to carcinogens, Z believe It
unreasonable to ignore a finding of cardnc-
jjeniaty In any mammalian test species
when considering possible effects on human
health."
O. Body burden and intake. There Is a
conclusive evidence that residues of Aldrln-
Dleldrln. are present in virtually every
member of the VS. population. An EPA Hu-
man Monitoring Study has established that
In 1971. 99.6 percent of the persons sampled
had Aldrln-Dleldrln residues in their adipose
• tissue.11 The compound also has been found
la the blood samples of 69 percent of the
population tested.1*
In the environment, Aldrin-Dieldrin la
most frequently present In food crops, and
the consumption of food has been man's
principal exposure to the compound. The
PDA's Market Basket Surveys have shown
that the compound is present most fre-
quently In dairy products, meat, fish, poul-
try, and fruits. Residues were round in 83
percent-IHJ percent of these products. These
particular commodities contained almost
all of the Aldrln-Dleldrln residues found in
the Market Basket Surveys. Although the
levels of these residues has fluctuated some-
what, there has been no significant decline
in their presence in recent years.19 Another
EPA Monitoring Study has found Aldrln-
Dleldrln residues in 8S percent of the air
samples taken."
There is Inconclusive evidence on the rela-
tionship between the intake of Aldrln-Dlel-
drln and body burden levels. However, It ap-
pears that the longer the exposure, the higher
the tissue level." The concentrations of Al-
drln-Dleldrln in the adipose tissues of the
general population have been found to be
comparable to the levels in mice exposed to
0.1 ppm of the compound.11 After exposure,
species eliminate the compound from their
systems at different rates. Rats excrete the
compound with a half life 4 to 6 times as
fast as mice and 13 to 28 times as fast as
humans.**
We are uncertain as to the precise effect of
Aldrin-Dieldrin on fetuses and infants • but
are concerned because their intake levels can
be over six times the so-called Acceptable
Daily Intake (ADI) level. Breast-fed babies
are particular susceptible, as virtually all
human milk has considerable Aldrln-Dleldrln
residue."
H. Epiilemiological studies. Epldemlologi-
cal studies on the corclnogenielty of Aldrln-
Dleldrln have been inadequate and Inconclu-
sive. Although It may be true that all known
human carcinogens have only been identified
through epldemlologlcal studies, the identi-
fication of the carcinogenic effects of Aldrln-
Dleldrln through such studies would be dif-
ficult because there Is no member or segment
of the human population that has not been
exposed to the compounds."
Shell has agreed that their epldemlologlcal
study does not prove that Aldrln-Dleldrln is
non-carcinogenic." Their tests detected no
effect among the subject population, even
though some mortality and morbidity was
observed,1* However no conclusion can be
drawn from these results because the teat
does not meet basic standards of accsct'.UU-
lty.*> The test population was too small, the
period of exposure was too short, and the
medical observation periods were not long
enough to approximate the expected latency
period of at least 20 years for Aldrln-Dlel-
drln.91
m. TBB USS9, BINCTIT3 AND lU-TTSNATTVES FOB
n EPA Ex. s-ie, pp 4-«.
•EPA Ex. 38, Tables I and n. EPA Ex. 5-
18. Other years deviated from these results
Insignificantly. Individual samples varied
widely from the mean of .27 ppm, with some
as high as 116.53 ppm.
n EPA Ex. 36, Table m. .
H EPA Ex. 38A, Table I and n. The average
Intake In 1973 was-.002 mg/day. (.00003mg/
kg/day). The study has been criticized for
having too small a sample and for poor
analytical methods; Its figures are unques-
tionably U.-V. (EPA Exhibit 30). (Tr. 15,281).
Although the absolute Intake values may
not be known precisely, their relative values
are evident from the study.
» EPA Ex. 37. There is evidence that this
figure may be low due to absorption In lungs
and clothing.
3 EPA Ex. 8Q.
u Transcript 397-698. Thus it may diminish
the relevance of placing the emphasis on
the intake rather than the tissue level.
» Transcript 899.
A. Relevance of thf benefits Issue. In view
of the foregoing health risks, do the benefits
" No tests have been performed on Infants
In any species to determine their level of
susceptibility. However, some scientists con-
sider it to be quite high.
•Transcript 32. The ADI (.0001 mg/kg/
day for Aldrln-Dleldrln) was established In
1966 long before the most meaningful tests
were run on mice proving the carcinogenic
effects of Aldrln-Dleldrln. Although the ADI
Is defined as a no-effect level. It is actually
a threshold level based on a rat study at 0.6
ppm In which exposed rats experienced liver
changes (Transcript 769) (Shell Ex, 4, p. 16).
"Many compounds Induced tumors of an
unusual type, which facilitated the identifi-
cation of the carcinogens. In other cases, the
tumor manifested itself in a distinct popula-
tion before there was a suspicion of corclno-
genlctty so it was easy to relate the effect
bock to the cause. These situations do not
apply to Aldrin-Dleldrln. As Dr. Gross testi-
fied: Even If Aldrln and Dleldrln were to pose
a very significant danger to humans, really
an Impressive, even a catastrophic one. we
would never know this. (Transcript 323)
- Shell S-t. p. 31: Transcript SOS.
"There was one death in the high ex-
posure group of stomach cancer, but this
death was considered insignificant. In the
same high exposure population, one worker
developed a tumor during exposure and an-
other, leukemia. It is Shell's position that
the test showed no Incidence- of enzyme in-
duction, liver injury, or the presence of al-
phabets protein. From this, they seem to
imply that this is evidence that Aldrln -Dl-
eldrln Is not carcinogenic. However, as Dr.
Farber has stated, cancer can develop with-
out these symptoms. (See EPA Ex. 3-13). Dr.
Von Roalte takes the lowest level of ex-
posure in this test, which la 17S x the ADI,
and adopts It as a no-effect level. (Transcript
p. 681.)
» EPA Ex. S-17. p. 11.
« EPA Ex. 8-10. p. 6. The average occupa-
tional exposure was 6.6 years; the average
observation period. 7.4 years; and the average
age, 47.4. There were 169 men who were ex-
posed at high does levels. (Shell Ex. S-t).
of Aldrin-Dieldrin Justify its continued use?
A related question la whether alternative pest
controls exist and will be available for the
1979 growing season. The "availability" of
alternatives assumes several factors, includ-
ing timely registration, effectiveness, ade-
quacy of supply, safety, and economy.
The following Integrated discussion per-
tains only to the possible effects of suspend-
ing Aldrln-Dleldrln for the duration of the
cancellation proceeding.
Since Aldrin-Dieldrin has been found to
be carcinogenic In mice and probably car-
cinogenic In rate, and to present a high risk
of cancer to man. It Is arguable that any use
of Aldrin-Dleldrln, however significant or
beneficial in social or economic terms, can-
not be Justified, even for the limited period
of time until the completion of the cancella-
tion proceedings.
As indicated in part I of this opinion, how-
ever, it Is appropriate that the possible bene-
fits of Aldrln-Dleldrln, or the absence of such
benefits, be considered In this proceeding.
Nevertheless, It is apparent that any benefits
attributable to Aldrin-Dleldrln must be of a
high order to affect the findings on carcliio-
genlclty.*3
The following sections, therefore, analyze
the major points raised in the hearing relat-
ing to uses, benefits, and alternatives, to
determine whether any of these benefits
Justify the continuing risk."
B. The significance of aldrtn-dieldrin uses
m corn. During the 1950's and 1960's, Aldrln-
Dleldrln became the leading insecticide for
the control of several corn pests.9* Prom that
period of widespread application. Aldrln-
Dleldrln use has declined to only about 8%
of the nation's total corn production acre-
age."1 Changes in corn production over this
period gradually have reduced reliance on
chemical Insecticides to sustain high crop
yields. These changes resulted from a variety
of factors, Including the benefits of new hy-
brids, the availability of synthetic nitrogen
fertilizer, and advanced farm management
practices.0* These changes in cultivation also
have helped to reduce- corn insect popula-
tions. Crop rotation practices and the In-
crease in soybean production in the last
decade have eliminated some of the favored
insect nesting areas.
1971..:
1'JTS
1973
1974 (preliminary)
Acres
(million!)
0 4
7.6
7.4
4.9
Percent of
U.S. com
growth with
aldrin
12.9
11.0
10.3
7.S
"EOF v. Bucfcelsnaus, 439 73A 584, 596 at
note 41.
"This evaluation does not necessarily
mean that the final decision In the cancella-
tion proceeding will be the same, for a wider
range of topics (Including other health
effects) and additional evidence on both
risks and benefits will be considered in those
hearings.
MSee EPA Brief, pp. 181-183. citing the
successes of Aldrtn-Dleldrln and Heptochlor
In the 1960's' (Decker Shell Ex. 12). Sales of
Aldrin peaked In 1966 (Shell Ex. Ill, p. 38).
and for corn use in Illinois In 1967 (EPA Ex.
60. p. 9);
" See EPA Brief, p. 207, citing 0SDA figures
(Shell Ex. S-17A) showing Aldrln use de-
clined from 13.4 million acres In 1966 (202%
of U.S. corn acres planted) to 7.6 million
acres in 1971 (10.2%). The Doane survey
shows a continuing decline alnce 1971 as fol-
lows: (EPA Ex. 3-16. p. 3).
"See EPA Brief, p. 1B3-188, citing testi-
mony by Dr. Petty (EPA Ex. SO, p. 2-3) and
Dr. Palrchlld (Shell Ex. 8-16, p. 12).
FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY, OCTOBER 18, 1974
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66
NOTICES
ho recent hearing strongly Indicated that
Incidence of significant Infestations'of
the major com soil insects today is extremely
lovtr. Per example. Dr. Petty testified that
there were no major corn Insect problems In
BUnoU in 1972." and Dr. Turpln stated that
•vtrewonn and cutworm populations In
iaduna were at a very low level." A research
team la Iowa, according to Dr. Owens, found
teas thug ten wlreworm incidents In 1972
and 1973. only two significant black cutworm
Infestations, and no white grub problems.1*
. Corn fanners, nevertheless, continue to use
large quantities of. Aldrln-Dleldrln as
prophylactic or "Insurance'' protection
against pote '.al pest damage..even where
an actual th.cat of economic injury Is not
specifically determined; In other words, the
pesticide is used even If there is no indication
that It is needed.''*
Aldrln-Dleldrln may no longer be as effec-
tive or as necessary In controlling these corn
pests as has been claimed or as bos been
assumed by Its users. These doubts are due
to the developing resistance to Aldrln-
Dleldrln by some corn pests, the current low
Incidence of corn insect Infestations on both
treated and untreated-acreage, and the lade
of recent data on the pesticide's continuing
potency.™
C. Alternatives to aldrln-dicldrtn for earn.
The most important corn Insect pest is the
rootworm. Since 1962. It has been known that
rootworms were becoming resistant to Aldrln-
Dleldrln.10*' and It Is now established that two
of. thtf three types of corn rootworms are
resistant.™ In view of the fact that other
Insecticides are available to control root-
worm.1''* and the fact that Shell apparently
does not place major Importance on the use
of Aldrln-Dleldrln for rootworm control."9
com rootworm control does not present a
r-ivlnclng need for the use of the compound '
373.
" EPA Ex. 60A, p.' 109; Transcript (Cancel-
lation) 11141-44. 1133; EPA Ex. 60, p. T.
•"Transcript (Cancellation) 11482. 11493.
11561; Indiana Survey for 1073-73, EPA Ex.
61. pp. 32-26.
•EPA Ex. 71; see also the testimony of
Dr. stockdale. Transcript (Cancellation)
32638. 22783. 22974.
'"•See. o-g., testimony of various fanners
that Aldrln has been used as Insurance
against Insect attack (Oarst, Transcript
(Cancellation) 284; Decker. Transcript 162;
Kirk. Transcript 22, 550; EPA Ex. 61. pp.
34-33).
» See testimony of Dr. Petty. EPA Ex. 61.
p. 36; Transcript 11360; EPA Ex. 60. p. 7;
Transcript 11398; and Dr. Sechrtest. Tran-
script 11794; EOF Brief HI A3. pp. 7-9.-
"» &:» EPA Brief, pp. 183-193. citing various
sources concerning what appears to be a con-
ceded fact in these proceedings. EPA Ex. 68,
pp. 3-4: Transcript 11074; EPA Ex. 60. p. 3.
""The two resistant species are Western
and Northern corn rootworm. See Recom-
mended Decision, p. 83.
"* Among the registered and recommended
alternatives listed by EPA are Furdan.
Thlmet, Dasamlt. Dyfonate.' Dlazlnon and
Mocap. Counter has a temporary use permit
and Is -expected to be finally registered for.
rootworms and wlreworms by late 1974. EPA
Brief, p. 193.
»•"• Shell apparently concedes that Aldrln-_
Dle!clr:n Is not an efficacious treatment for"
rofT-vrrms. No arguments for Its use on root-
worm; ire set forth In Shell's Brief No. V In
the cancellation proceeding or In their post-
hearing brief In the suspension proceeding.
The Chief Administrative Law Judge specifi-
cally found corn rootworm control not to be
islderatlon with respect to the need for
n-Dleldrln. Recommended Decision,
p. o3.
The black cutworm generally Inhabits
low-lying, poorly-drained river bottom land.
heavy soils, and the low. wet areas of upland
fields. The loss in crop stand and yield from
cutworm Infestation can, on occasion, be
substantial.10*
Wlreworm Is the third major com pest.
It appears to be associated with cropping
patterns where corn-Is grown after sod or
pasture, and Is primarily a problem only In
first-year corn..Thus. It Is generally not a
problem after the first year or where soy-
beans and corn are rotated.
The record Indicates that registered al-
ternatives are available for all these pests.
although Shell disputes- their effectiveness.
For corn rootworms, the alternatives Include
Dlazlnon. Mocap, Thlmet, Furadan. Dasonit,
and others. Most of these, and other chemi-
cals..also an registered as effective for con-
trol of wlreworms. Alternatives registered for
cutworms on corn Include Carbaryl. Dylox.
and Dlazlnon. with registration pending also
for Furadan.11*
Minor soil Insects, such as white grubs,
seed corn beetles, seed corn maggot, grape
colaspls. corn blllbug. Japanese beetle, Asiatic
Garden beetle, corn root aphid, corn field
ant, flea bottle larvae, or clover root borer.
.do not pose any significant economic threat
to corn production.111* Where white grubs d»
exist, some control can be obtained by
organophosphates, such as Malathlon, or
carbamates used to control rootworms; or
wlreworms."*
The record further Indicates that these
alternative pesticides should be available In
sufficient quantities for the 1978 season.
'•specially since a pound-for-pound substi-
tution for Aldrln-Dleldrln Is neither neces-
sary nor desirable."* Shell's own estimates
of available supplies Indicate significant In-
creases In production of some alternatives
and continued high production levels for
most others."1
D. Projections of corn crop reductions.
Corn production In the United States Is of
considerable Importance to the nation's econ-
omy. Fortunately, the suspension hearing
record indicates that the macroeconomle 1m- •
pact of the proposed suspension order would
be almost negligible.
The most reasonable projection10 was the
study conducted by Dr. Delvo of the XT.S.
Department of Agriculture, who predicted
that corn crop reduction could amount to as
much as 0.4% of expected production."1
"» Sechrlest, EPA Ex. 63O. p. 3.
«"EPA Brief. Table, pp. 176-177. Hepta-
chlor and Chlordane also are registered and
effective for certain applications. The Agency
does not consider them safe alternatives,
even though the scientific case against them
is not yet as complete as that against Aldrln-
Dleldrln. (See also p. 39. note 1).
139 See testimony of Dr. Turpln (EPA Ex.
61. p. 40); Transcript (Cancellation) 11141,
15330-3.
"•See EPA Ex. 60T, p. 88. showing some
control of white grubs with band applica-
tions of Dasanlt, Dyfonate. Dlazlnon. Thlmet,
and Furadan.
»»Hopefully, one result of this decision
wiu be to reduce unnecessary "insurance-
applications of Insecticides and to limit their
usage to situations where they can prevent
significant economic Injury.
111 Production of Furadan. Dyfonate, and
Mocap. among others, will be substantially
increased next year. Shell Brief, pp. n-8 to
n-13: see also EPA Brief, p. 206.
11S Judge Perlman described the Delw»
Study, despite certain problems, as "the on
economic study offering some reliance.'
Recommended Decision, p. 79.
'"Shell Ex. S-17A.
Even this-estimate may be considerably in-
flated, aa EPA witness Dr. Aspelln. pointed
out; because it (wnimn a level of wlreworm
and, cutworm Infestation considerably la ex-
cess of current field estimates.11*
A second study was conducted for Shea by
Doane Agricultural Service. The fanners' loss
estimates were ten times as high aa tha
Delvo prediction, plus another five times du»
to a claimed shifting of production from
corn to another crop.0* This projection seems
somewhat high, considering that Aldrln-
Dleldrln la used on less than 8% of the
nation's total corn" crop. Shell has conceded
that "because of certain methodological
problems and the questions concerning the
ability of farmers to make estimates, Mr.
• Wllkln's estimate, may be too high.** "•
A third study.'conducted In 1973 by Or.
Freund, assumed the simultaneous unavail-
ability not only of Aldrln-Dleldrln but also
of Chlordane and Heptachlor, and conse-
quently projected losses in the range of 0.7
to 1.8 percent. This "very rough study."
which* was clearly1 "tentative and pre-
liminary." cannot constitute a reliable basis
for'a conclusion on macroeconomle impact.10'
It is possible'that there may be no crop
reduction at all due to the lack of Aldrln-
Dleldrln. For fields with significant insect
damage to the young plantsxcrop loss can be
greatly reduced by Immediate, replanting and
treatment with an alternative pesticide.'"
This I? a common practice and may be less-
expensive overall than extensive prophylactic .
treatments used by many-formers.
2, therefore, concur in the finding of Judge
Perlman who, after reviewing the above
studies and projections, concluded: "On the
basis of the foregoing, we cannot find any
major economic or social benefit resulting.
from the use of Aldrln on corn in the con-
text of overall effect of Its unavailability for
such use." "»
E. CUrua uses of oldrtn-ileldrfn. Although
the benefits portion of the suspension hear-
"•Ibld.
. °* Shell Ex 168.
»shell Brief, p. n-19. The hearing ex-
aminer concluded. "We totally reject the
Doane Agriculture Service; ffrq. special
survey and projections of loss • •' ». On. Its
face. It la patently exaggerated, employs
'double counting compounded,' is based on a
small sample from which averaging.projec-
tions are made and elicited the views of
Aldrln users who would not in reality know
with any precision the effects of'the absence
of Aldrln and who, it seems to us, would
demonstrate a bias." Recommended Decision,
p. 79.
ut Recommended Decision, p. 79. Even
though the EPA staff believes that Hepta-
chlor and Chlordane pose a "substantial
question of safety" sufficient to initiate the
cancellation process, and therefore does not '
recommend them as alternatives, as a factual
matter these compounds will be available for
the 1973 growing season: The fact that the
Agency has not yet Initiated administrative
proceedings on Heptachlor and Chlordane Is
not. relevant to the hazards of Aldrtn-
Dleldrln. It would be extremely irresponsible
to refrain from banning the use of one
carcinogenic compound because another
compound might also have carclnogMile,
effects.
,"• Shell Brief, p. 10.
«*» Recommended Decision, p. 81. Regard-
less of minimal economic Impact at the na-
tional level, it la always possible that some
Individual farrrier3J'ma.y - bo more disail-
raatoged than others by the suspension of n
rarttculor pesticide, it Is my Interpretation
i the F1FRA. however, that these burdens on
.r.dlvldual farmers must be sevtre and wide-
spread to Justify ;xr--wing tti* entire popula-
tion to a demondt.-aced carcinogen.
HDMAL REGISTER, VOL 39, NO. 203—MIOAY. OCTOBS.U 18. 1974
-------
67
NOTICES
ing dealt almost solely with can, there are
a number of "minor" uses for which the
Department of Agriculture (TTBDA) contends
that Aldrln-Dleldrln la eiBHmtial. The most
Important of these la the use on various
'citrus pests In Florida.1*
Aldrln-Dleldrln and other inseetleides for
control of the Puller Hose Beetle are only
•used on 1-6% of citrus acreage in Florida.10
Even in the Indian River area of Florida, son
Insecticides have been applied only to some
30% of the acreage."1 As with corn. Aldrtn-
Dleldrln has been used extensively for "insur-
ance*" protection on citrus* where actual eco-
nomic risk has not been specifically deter-
mined.13'
Other Florida citrus peats include the
blue-green citrus weevil and the sugar cane
root stalk borer weevil (diaprepes) . but these-
are very limited problems, both geographi-
cally and la magnitude. Only about 1% of
Florida citrus acreage is subject to weevB
tufjMttatltfflj ?***! of ***** Aldrln^ieldrln .Is
used on somewhat more *>*«"* one-half.1"
Although fewer acres of citrus than con
are treated with Aldrin-Dleldrin. the.rate of
application per acre id considerably higher.
Whereas the rate on com is one to two
pounds per acre, the rate en euros la five
pounds. These "minor" -uses on Florida citrus.
therefore, account for 130,000 pounds of
Aldrin-Dleldrin a 'year.1** . '
Alternative foliar sprays and organophos-
soil inT*rfei^'1a questioned whether Aldrln-
Dleldrln remains effective against citrus
pests. The most recent test waa conducted
16 years ago by Dr. King, who concluded that
"1rm was only effective 70% of the tune.
P Brief, m-B, p. 52,
F. Seed treatment usoa o/.4IdXn-DieIdrm.
• Aldrln-Dleldrln Is used in seed dressing'for
many types of grain, fruit, and vegetable
seeds as a prophylactic measure.'" normally.
only two to four ounces of dressing per 100
pounds of seed is applied, either In commer-
cial seed preparations or by the farmer dur-
ing planting."* This amounts, however, to
130.000 pounds of persistent Aldrtn-Dleldrtn
entering *** environment per annum.13* This
hazard Is unnecessary, for alternative seed
itia«^|itq« are available? Dlszinon, Fif1**^11^
and BHC (in Canada) are used effectively for
this purpose. Proper cultural practices also
can reduce ***** need for seed treatment.
There Is, therefore, little or no evidence
that Aldrtn-Dleldrln seed dressing is needed
to prevent "tgr^W**"1* g»i*tfti or economic
Injury. •
Q. Other minor uses o/ AUHn-DUUrta.
Many other uses of Aldrln-Dleldrln, Includ-
ing Puerto Rlcan pineapples, sugar cane, and
H'MiflTiflfi ftni^Tia arowu in the Tulelake **«*«*"
of Northern California, strawberries in Ore-
gon and Washington, the TSDA's quarantine
program."" cranberries, and nursery stock,
are dnfended by the TJSDA in this suspension,
proceeding. Registered alternative insecti-
cides are available for these uses during the
period required for the 'completion of the
«m«.n.«nT, proceeding.^ Registration of ad-
ditional alternative Insecticides is pending.
With respect to these other uses, there Is
no oasis on the record to conclude that slg-
ntfltHmfe-yiMa^ rpf ff^ff^fffn^n mJUTJf tO ^* ftft-
tion or to individual growers would result
fiiuii tne suspension of At*^^^-^***1*^11
»See. e*. Transcript (Cancellation) 3468:
3335; 3263.
"•See Transcript (Cancellation) 23766-7;
33791.
» The M"» of • Aldrin-Dleldrin to of the cancellation
proceeding. Further evidence and further
consideration in
1. .Based on the testimony of record in the
suspension hearing and the considerations set
forth in Part n of this opinion, X have con-
cluded fl<»* the continued use of Aldrin-
Dleldrin during the time required to reach a
final decision in the cancellation proceeding
would be likely to result In unreasonable
numan health risks •"*•*, -therefore, that an
••imminent hazard** within this tmnmt^ig 'of
section 3(1) of FD7RA would result during
the pendency of the 'oanoeUatlon pp>*«*«HiTig
3. I have concluded further, based on the
testimony of record ttl^ t^^ iy%ti^rfo|^^j^n«
set forth In Part m of this opinion, that
there are. no ^QUBt4fni<*j^*t*g'bftpftfltB resulting
from the registered uses of Aldrln-Dleldrln
dif-
ferent conclusion regarding Aldrln-Dleldrln
use on citrus or seed' treatment. Such con-
clusions, however, cannot be reached on the
basis of .the suspension hearing record.
4. The effect of this decision will be to
severely restrict the amount of Aldrln-Dlel-
drln which wfll be placed into the environ-
ment during the 1875 growing season. It will
not completely curtail the vMltlgn of these
compounds into the environment, since the
use of existing stocks
-------
68
Appendix B
-------
FEDERAL REPORTER
econ
Volume 510 F.2d
in tli,
UNITED STATES COURTS OF APPEALS
UNITED STATES COURT OF CLAIMS
UNITED STATES COURT OF CUSTOMS
AND PATENT APPEALS
AND
TEMPORARY EMERGENCY.COURT OF APPEALS
ST. FAtrt. UZHV.
WEST PX7BLISHING 00.
1976
-------
1292
70
510 FKDKRAL REPORTER, 2d SERIES
I
trial, we think the witness.under exami-
nation may nut tic asked to pass upon
tin; mental condition of those artists. To
do .so raises collateral issues foreign to
tin: trial or appellant. Morwivcr, the
|i:iinline of ap|»ellanl referral to by his
witness, if they can lie niailc available,
tthniild lie exhibited to the jury for com*
purr.dn with any paintings of the well-
known artists which might In* exhibited.
Unless these precautions, with any oth-
iM1* thought appropriate by the trial
jndpj, are taken, the proceedings Iwcomc
so misleading us to l>e quite unfair to the •
jury and, therefore, to appellant We do
not question, however, the right of the
prosecution to seek to refute liy expert
testimony the appropriateness of using
the paintings of a patient in aid of diag-
nosing his mental condition.
When considered together the several
difficulties we have noted affecting the
second pha.se of the trial combine to lead
us to reverse the verdict on the insanity
iiisuu and to remand the case in that
reaped for further proceedings consist-
on! with this opinion, while affirming
the verdict reached on the first phase of
I lu* bifurcated trial.
It is so ordered.
SUPPLEMENTAL OPINION
FAIIY, Senior Circuit Judge:
The opinion of the court of April 7,
1975, 1G7 U.S.App.D.C. , 510 T2A
1283, 1288, refers to a motion of stipula-
tion proposed to be filed by counsel for
appellant correcting, as erroneous, a por-
tion of the transcript of Uie trial relied
upon by the United States as constituting
a waiver of apiiellaht's claim of right to a
separate jury. Our opinion slates, "we
have received no stipulation or motion
. . ." The fact is an order of the trial
judge correcting the record, baaed on a
stipulation of counsel for the parties, was
filed prior to argument of this case, but it
was not brought to the attention of the
court until subsequent to issuance of the
court's opinion April 7, 1975. The stipu-
lation and order confirm the analysis of
the transcript in all relevant reflects a*
made by the court in its opinion.
ENVIRONMENTAL DEFENSE FUND,
INC, and National Audubon
Society, Petitioners.
v. ...
ENVIRONMENTAL PROTECTION
AGENCY and Rumwll E. Train,
Administrator, Respondent,
Shell Chemical Company and Earl L.
Butz, Secretary of Agriculture, .
Intervenor.
SHELL CHEMICAL COMPANY,
DIVISION OF SHELL OIL
COMPANY, Petitioner,
ENVIRONMENTAL PROTECTION
AGENCY and Russell E. Train, Ad-
ministrator, Environmental Protection '
Agency, Respondents.
FLORIDA CITRUS MUTUAL,
Petitioner,
v.
ENVIRONMENTAL PROTECTION
AGENCY and Ruaacll E. Train, Ad-
ministrator, Environmental Protection
Agency, Respondents.
Earl L. BUTZ, Secretary of Agriculture
of the United States, Petitioner,
v.
Russell E. TRAIN, Administrator of the
Environmental Protection Agency,
Respondent.
Noa. 74-1924, 74-2113, 74-2114
and 75-1092.
• United States Court of Appeals,
District of Columbia Circuit.
Argued- Feb. 7, 1975.
Decided April 4, 1975.
On petitions for review of an order
of the Environmental Protection Agency
suspending the registration and prohibit-
ing the manufacture and sale of the pes-
ticides aldrin and dicldrin, the Court of
Appeals, Leventhal, Circuit Judge, held.
!.,
i
\'\
inter al
rationu
ported
and si
and (2
the su
parte <
onforv
Involv-
hcorii
consul
and a
cept i
suspe.
. 5
that
stock
furtl:
l.; P.
ordc
proh
. the
rat'n
port
and
Fed
Act
2.1
fln<
imt
qui
evi
da i
ic
coi
tio
at
of
al
VI
m
tl
' ii
-------
71
•4
KNVIIIO.NMKNT.tt, T). R, INC. v. ENVIHONMKNTAL PRO. A«CV. 1293
nil- •* (kill KM ISM I Illttl
itr itlia, lh:ii. (1; Lhc EPA's order WIIH a
rational exi-rri.w of ili.sriv1.ion anil sup*
|HI failed In establish that
the .tuspcni'ioii order was tainted by ex
parlc commui'ii-al.ions. from the Agency's
enforcement clnil', who were at the time
involved in a continuing cancellation
hearing; rather, there was no claim of
consultation U.a.veen the prohccutorial
und adjudi'-ativc stuff of the Agency ex-
cept on tli'.- issui; of whether to start u
suspension pn.ivi'iling.
Siis|>::ii:iii»•!)(Iin|,' the registration and
•>ri>hibiliiitf (in: iuaniifactun; and snlc of
.he pesticides aMrin and dieldrin was- a
rationale. c\cii-i--': of discretion and su|>-
^icrlcd !>y thv.- reasoning of the Agency
t.nd sulislanluii evidence in the reconl.
Federal Environmental Pesticide Control
Aet of l!>7i>, § Oc), 7 U.S.C.A. § 13(kl(c).
2. Poisons ^=»2
Knvironiti. '.i:d Protection Aycncy'a
finding thai :;'i!:-in/dieldrin presents "an
imminent ha/nnl during the time re-
quired for rain>.!lHtion" hud an adequate
evidentiary I ;i; is, including scientific
data that I he p'.stiddes were carcinoKen-
ii* in mi<-u and r.ils, and- that a causal
connection exists between the iinplunla-
liun of lh2
Within provision of the Federal En-
vironmental Pesticide Control Act per-
mitting the suspension of a registration
while a cancellation hearing is pending
when ."the Administrator determines
that action is necessary to prevent an
imminent hazard during the time re-
quired for cam-elation," the term "immi-
ncnt hiuarH" is not limited to n concept
of crisis; it in enough if there is a sub-
stantial likelihood that serious harm will
be ux|x:ru:ncuut places the burden of estab-
lishing safety on the applicant und regis-
trant. Federal Environmental Pesticide
Control Act of 1D72, § 6(c), 7 U.S.C.A. §
13Gd(c).
5. Pol.sonu «=»2
Conclusion of the Administrator of
the Environmental Protection Agency
that the pesticides aldrin and dieldrin
present an "imminent hazard" to man
because the (raticides are carcinogenic in
mice and probably carcinogenic in rats aa
well was a conclusion within the scientif-
ic expertise of the Agency and was not
infected by error of law; likewise, the
validity of extrapolation to humans from
data derived from teals on animals was a
matter within the Agency's expertise.
Federal Environmental Pesticide Control
Act of 1972, § 6(b, c), 7 U.S.C.A. §
13Gd(b, c).
6. Poisons o=»2
Although extrapolation of cancer
data from mice to man may be quantita-
tively imprecise, it is sufficient to estab-
lish a "substantial likelihood" that harm
will result from Ihc use of pesticides
found to be carcinogenic in mice. Feder-
al Environmental Pesticide Control Act
of 1972. § 6(c). 7 U.S.C.A. § 136d(c).
7. Administrative Law and Procedure
«=»502
An agency is not required to adhere
to a prior policy with iron rigidity; all
that the law requires is that it explain
the reasons fur a modification.
I
;j
i!
ir
(i
«i
i!
II
''*
SM
l*\l':.
, .1
II
s
it
a
i
1
j(
il
.
:•
•
r
i
,
't
i
! I
I1
I!
I,
?!:,
f;'
'*;'
:ii-
'••&
\..
' •:••}'•
• '.r. I
1
^
i
I
I
"-*i
i
-------
I
72
1294
510 FEDERAL KKI'OKTEK, 2d SERIES
8. Poisons <*=>2
His previous refunds on a different
record, to aus,«nd the rc,..i.stration of •
aldnn and dicl.lrin did not strip the Ad.
ministralor of the Environmental Prolec-
lion Agency ?f discretion to make a |H,li-
cy judgment that, Ixtausc of new infor-
mation elicited, the uncxjxsct.',) length ,.f
cancellation hearing nn.l a thr^il liy tl.o
manufacturer lo commence pr,Nluc«ion ,,f
the pesticide* for the 1975 souson. the-
nsk posed by the registration hud in-
creased significantly and suspension had
become necessary. Federal Environmen-
tal Pesticide Control Act of 1D72. § GH,
c), 7 U.aC.A. § 13Gd(b. c). '
9. Poisons «=»2
Record supported Environment N I
Protection ARCMcy's finding, in supporf.
of Iho suspension of the registration of
aldnn and dicldrin. of a "..utataiiii.il
likelihood" that serious harm to mn,,
would result from the continued use of
the pesticides for the treatment of ccrn
601 insect*. Federal Environmental P2
Conclusion of the Administrator of
Knvironmfint.il Protection Agency, in
-rt of order .sus|K?nrtt IKISO the
swmo cancer risk as aldrin and dieldrin
snp!K,rted the fin.linff \hat available al-
lor.-,atives were environmentally 9uit-
«l>io. Federal Environmental Pesticide
Act of l972.-§ 6(b. c). 7 U.S.C.A.
10. Polaonn
It is not nccc.ssary. to have uvideneu
on a specific use or aren in ortlcr to IK;
able to conclude on the basis of gubsUin-
Ual evidence that the use of a jwsticide
in general is hazardous and that the rcir-
istration of it should therefore be sus-
pcnded. Federal Environmental Pcsli-
cide Control Act of 1972. § 6(c}, 7 U.S
C.A. § 136d(c).
11. Poisons «=»2
Manufacturer of the sus|>cnded pc3-
Ucides aldrin and dieldrin. which- were-
shown to create a risk of cam-er in hu-
mans, failed to cst:dj|ish that the bene-
fits derived from the |>cstici,le* out-
weighed the harm done by them.
12. Poisons <=2
Responsibility to demonstrate that
the benefiu outweigh the risk is upon
the proponents of continued registration
of a chemical poison.
13. Poisons c=>2
Where the KnvironmcnUd Protec-
tion Agency declines to suspend the rcg-
15. I'oisbna o^'J
When the .-iiiliject is risk of cancer.
i-onvi-nicncc may !>e relevant but it does
"••I. weigh' heavily in determining wheth-
er the registration of certain pesticides
shMjId be su.sK-n.Jod. Federal Environ-
f:i-..-:ital PcHtici2
While a more careful exploration of
t.-ir .lyailuhiliiy of alternatives for minor
U.VM would he contemplated for the final
duir-rmination on the cnncellation vcl
"•>n <,f the rrpslration of the paslicides
i'.l'lnn and dicldrin, no such extended dis-
oussion of the rvidcncc could be demand-
-.'.I for every use of those pesticides at
ihu ciTii-rgcncj-, provisional stage involv-
ing .^sponsion of the registration. Fed-
eral Environmental Pesticide Control Act
of 1&72, § 6(b. c). 7 U.S.C.A. § 136d(b, c).
17. Poisons «=>2
Notwithstanding claim that findings
of the Administrator of the Environmen-
tal Protection Agency were too incom-
plete to be adequate for an order sus-
pending the registration of aldrin ami
I
:!
'«
-------
KXVIUONMKNT.AL D. P., INC. v
dieldrin, it was sufficient, in view of Hut
statutory time constraint under whi.-ii
the Administrator aclud, that there was
substantial evidence in the record nrul
that the reviewing court was able to dis-
• ccrn tlic fair imjwrt of .the Administra-
tor's reasoning. Federal Environmental
Pesticide Control Act of 1072, § G(c)(2) 7
U.S.C.A. § 13Gd(c)(2).
18. Administrative l.aw and Procedure
. KNVIKONMBNTAI, IMIO. AfiCY. IMK
•.2ill2K!ll'.lV.-,|
eral Knvir'iiiniunlnl Pwlicidu Control Act
of 197::, fc <5(c). 7 U.H.f:.A. <
Where the administrative record is
complex and the time for explication
brief, judicial review is conducted on Ihe
basis of the record as a whole, so that
rather conclusory findings can l»e re-
deemed by resort Ui a detailed factual
record.
19. PolsonH c=»2
Record failed to establish that Envi-
ronmental Protection Agency order sus-
pending the registration und prohibiting
the manufacture and side of the |>esli-
cides aldrin and diclilrin was* tainted by
ex partc communications from the Agen-
cy's enforcement staff, who were at the
time involved in a continuing cancella-
tion hearing; rather, there was no claim
of consultation between the Agency's
prosecutorial and adjudicalivc staff, ex-
cept on the issue of whether to start, a
suspension proceeding. Federal Environ-
mental Pesticide Control Act of 1972, §
6(b, c), 7 U.S.C.A. § 13fid(b, C).
20. Poi.sonq c=>2
In rcspert to October, 1974 Environ-
mental Protection Agency order suspend-
ing ihi! registration and prohibiting the
manufacture mid sale of the (Katici'dus
aldrin and diclilrin, that part of the or-
der exempting existing stocks of the pes-
ticides would be remanded for further
consideration, as the Agency was
presented in January of 1975 with esti-
mates that approximately five percent of
the total 1374 amount of aldrin granules
would be available for use in 1975.
• Silling by designation pursuant to 28 U S C «
293(a)
U The suspension order covered nil pesilritlr
products containing uldrin or dielUrin for '
which apiwuU had tui-n fllctl from EPA's
June 2li. 1972. notice of e.inccllutlon. Certain
for review of an ordor of the
Environmental Prolr-vlion Agency.
William A. Butler, with whom Jacque-
Hne :>f. Warren, John F. Picnelt, and
John T. Shinkle, Washington, D. C., were
on th«r t.ri<.'f for rxjlitiuncrs in No. 74-
1924.
iis a Lyons, Washington, D. C.,
with wh.-m David H. l.loyd, Andrew S.
Krulwich, and Linda F. Blumenfeld,
Washington, D. C., wen: <»n the brief, for
petitioner in No. 74-2113 also argued for
petitioner in No. 74-21M.
Raymond W. Fullerton, Atty., Dept. of
Agricul'.iinr, with whom John A. Knebcl,
Gen. ('-t, James Michael Kelly, AsaL
(Jon. Cinmsul, and Uinhard S. Wnsser-
strorn, Atty., Dept of Agriculture, wt:ro
on the brief for petitioner in No. 75-
1002.
Churl.* W. Line, III, N«w Orleans,
La., was vn the brief for petitioner in
No. 74- 2114.
Mirha.tl II. Stein, Atty., Dept, of Jus-
tice, with whom Carla A, Hills, AasL
Atly. C}...n.t Stephen F. Eilpcrin, Atty.,
Dept. of Justice, and William- E. Reu-
kauf, Atty., Environmental Protection
Agency, were on the brief for respon-
dents.
Befoev WRIGHT antl LLCVENTHAL,
Circuit .rU''.ges, and DAVIS,* Judge,
Unit.Ml Stales Court of Cluims.
Opiitiini for the Court filed by Circuit
' I.KVENTHAL.
LKVENTHAL, Circuit Judge:
This CJIA»J involves tlie validity of an
order is-simd by the Administrator of the
Environinrohibiting the manufacture
and sale ' of the pesticides aldrin and
minor usv.t— (he dlppiiiR of roots or tops of
noii-foxJ plants, subsuifaue ground insertions
for termite control, ami mothproofing by
thoso manufacturing procctsrs that utilize the .
pesticide in a closed system— were exempted
MI ;
.. r ,
•:??«
. •.•.tf.s
-------
it:
1296
510
„,„, Silr,
„
IWe
'••>*
'• THE ORDEU
» Occumlicr 3. 107n pnt' r
wl ' "* flrst
of
anc
ns
Admini.,lrator l
to cancel.
seed- rnfr lhat <
It.
greater quanittirs. [„ ,37," "5<'J ln "«uch
million pounds of aMrii, "°St •tWelv*
only about 7oocoo imi,.!!. W
-------
75
-'•'ili'iiui "Li
KNVIKONMKNTAI. t). F, INC. v. ENVIRONMENTAL Pl'lO. AfiCY. JV
me:nl of a public hearing.' When EDF
sought review in Ihi* court of Ihu refusal
lo sus|>end, we remanded for further con-
sideration in light of the Ileport of the
Advisory Committee, which was issued on
March 28, 1912. Environmental Defense
Fund. Inc. v. Environmental Protection
Agency, l.r>0 U.S.App.D.C. 348, 405 F.2d
028 (1072). After considering the lle|»ort
and further public comments, the EPA
issued an order on December 7, 1972,
which affirmed im previous decisions to
issue a notice of intent to cancel, without
interim susitension.
Cantx-llation hearings began before
Chief Administrative I«aw Judge (M.I)
Perlrnan on August 7, 1973. Twelve
months into llu> hearings, on August 2,
11)74, UK; Administrator issued a nutir:e
of intent lo sus|iend on the ground that
evidence develop! .since Dccemlier 1972
indicated that the continued use of uld-
"•n/dieldrin presented an "imminent haz-
" lo Ihe public. Shell and USDA re-
oslcd a public hearing on the su»|x.-n-
sion question. The hearing began before
ALJ Pcrlman on August 14, 1974, and
wart concluded on September 12, 1974.
ALJ Perlman recommended suspension,
and, on Oclol>er 1, 1974, the Administra-
tor susjxjndt-d the registrations.
We will first develop the general pur-
pose and validity of the order, with a
brond overview nf its reasoning and the-
aup|K>rling evidence. Then we shall turn
lo certain particular objections presented
by the parties.
II. GENERAL VALIDITY
[1] Turning first t0 the broad ques-
tion of validity raised by cases like this,
the court concludes: The EPA's order is
a rational exorcise of discretion, rather
than arbitrary agency action. It is su|>-
«. Undir the terms of I la- Act applicable ut ihe
lime, the report of the Advisory Committee
wn» lo issue before thr comim-neetnent of the
ninisiruiive hearings. $ 4(c), 78 Slat. 130 '
«). Thai provision was amended in 1972
provide that the lu ;inn« oxaminw could, at
his own o(ition or at die request of any parly,
refif rclrvnnt question* of scii-ntific fact to "a
310 f .2J—»J
ported liy'lhu iXM
and by substantial
rccaH.
A.
of the ar.'.-ncy,
evidcnoi in th<|
The .SVri/x.- nf .Imliciul Ru\-ic\v
[2) The primary challenge rnist-1 by
Shell, FCM, ami tl,,- UHDA goes to the
adequacy of the- evid.rnliury basis of the
EPA's finding that aMrin/dicldrin
presents "an imminent hazard [to :rian|
during the lirni- rvrpu'red for <-anrelh-'
lion."
[3,4] We have cautioned that the
term "imminent hai-a.-..'" is not limii.-ii to
a concept of crisis: "II is enough if there
is aulmtuntiul //A<•/!/;.„*/ that ^-ri.ms
harm will be rtcd
Committee of the Nuiionnl Academy of Scl-
7 U.S.C. (j I3r><|(d) (Supp. II,
7. If no request for a hearing i, IT)atll. lhe
suspension order takes efit-ci and is not re-
viewable by n court. § (J(r)(^. 7 U.SC S
ia6d(r)(2) (Supp. ||f ,972). A" *
•'I
:
r
11'.'
•Vj. .
(M-l •
!;:'! •
'
)li
11.
i f.
I'i
-------
76
1298
510
»BPOl«TBR. 2d SERIES
evidence when con-
on the record as a whole."
«f "substantial
support
In applying this principle to rcv.W of
a suspense decision, this court has said
me function of the suspension d ' ' '
13 vO fll&JCG A ni*ol it** i **n •••
••••»f%«= n tircurninnry &ssc$Sfncnl of
evidence, and probabilities, not an ulti-
mate resolut.on of difficult issues We
cannot accept the proposition .
that the Administrators findings ' '
[are] insufficient because controverted
by respectable scientific authority. It
VS^S*^?" ^ lh« i--
.. -••—"i«j icapvcuiUlO
«• • . , authority supporting thc Ad-
ministrator." Environmental Defense
.Fund. Inc. v. EPA, supra, 150 USApp
u.C. al 357, 4C5 F.2d at 637. '
B. Carcinogcnicity of Aldrin/DicMrin
Although the cancellation hearing en-
compasses a broad range of issues con-
^"elfviriL^r1 °f aldn'n/tlicldrin «"
L • I* ' " Cll 39 Oil llUItlllfl
DC'np, the supenaion hearing was con-
fined to whether the pesticides present a
cancer hazard to man." The Adminis-
trator concluded that aMrin/dieWrin
presented an vjlnniinctit Inward" to man
on the basis of data indicating that i; is
carcmogcnic in five trains of mi«j and
as corroboration. indications that "t>«r«
is a strong pn^nhiliLy that Aldrin-Diel-
drm is a carcinogen in ra* M w.c|,
mice. '*
1. Mice Data
Shell attacks the Administrator's re-
liance on mice data on the ground th^
thc inadequacy of present knowlc^M re-
garding cancer and the difficulty of CT
trapolating from mice to men render'ha
decision speculative.
f5J Thc Administrator's failure 10 ce-
tcrnune a threshold level of erno9t,«% .,
n Irli^ y*j "ii" •»i«'S^irv 40
minalCn" d°C'3 "^ ^^ his det*"'
minauon .mpro^r, for he has concluded
viiai me concept of u thr^sholrl
level has no practical significanrcChe-
carcinogens arc concerned. This \A "
m part to thc ir'rcvcrsibilitv
latency period of carcinogens'
as cancer," » and the
«te places the burden on the
130n(b>
- ass-minp a sulstantial show.
of_ danger, require the Administrator
to make impossible proofs. In r
admimslrativc actions, courts
fairly demand the perfect at the
of the achievable."" The AdmmUirn-
tors conclusion is within the scientific
to support a conclusion." "•
A.O. 7.
A.O. 23.
manAxJ 417 US ^L^"1^ an>l "'
3I67' «'
-------
• ?77
KNVIliONMENTAL I). F, INC v. ENVIRON.MKNTAL PRO. ACCY.
li.*e of the agency, ami is not in-
fected by error of law. Compare Envi-
ronmental Defense Fund, 1m-. v. Ruckel-
slmus. .in/in,, U2 U.S.App.L).C. at 8G 4M
F.2d at 5!Mi. ' '
[6] The validity of extrapolation to
humans from dau derived from lusts on
animals is ;dso a mailer within the agen-
cy's cx|*:rlise. There was testimony Iw-
fore the A significance' of test ani-
mal dula when cancer JK involved." Use
of animal data is particularly appropri-
ate whei-e, as here, accuralo cpidomiolou-
ii:al studies c.aiiiiot IKJ conducted Iwcause
tin; virtually 'universal contamination of
humans by residues of aldrin/dieldrin "
make it impossible to eataMiah an uncon-
tamtnaled human control group. The
long- latency period of carcinogens fur-
ther -hinder* cpidemiulogical research,
d the elliical problems of conducting
.nccr ex|K.rimcnl5 on human beings are '
too obvious lo require discussion. Al-
though cxlr:i|K>lulion of data from mice
to men may lx: quantitatively imprecise,
it is sufficient to establish a "substantial
likelihood" that harm will result. Cf.
Society of Plastic* Industry, Inc. v
OSHA. 50(1 F.2,1 1301, at 13(W (2d Cir
Jan. 31, K»7.r,).
Shell claim* that tests basc:d on mouse
data are not sulwtanlial evidence, be-
cause mouse livers are unusually suscep-
tible lo cancer. Still, Shell's data—of
statistically significant incidence of ma-
lignant liver tumors—were in strains of
mice that were, as was noted J>y the
Administrator, unusually resistant to
such tumors." In any event. Shell's ol>-
jections are outweighed by the substan-
tial evidence supjxjrting EPA's dctermi-
ls- E S: J.A. 1997 98 (u-slinuiny of Dr. Up-
ton); J.A. 9lfi (testimony of l>r. ilpstun) J A
903 (testimony of Or. Farbrr).
16. Environnii-nt;il Defense Fuml. Inc. v. Ruck-
elshaus. sii|ir.i. 142 U.S.App.D.C. at 86 n. 41
10 FJd at 5yu n. 41.
note .10 Infra and ai-conipanyln« text.
nation that mice arc not uniquely sus-
ceptible in catxinojrena, but arc, in fact,
(good predictors of carcinogenic hazard to
man. Tlio Adminiatnilnr found that ro-
. dents arc- particularly useful experimen-
tal unimals. in part Iwcau.su of the simi-
larity of their response to carcinogens to
the res|w,r,-.e nf man, their short lifcspan,
and our relatively well-developed under-
j landing of tin: imllioio^ical development
of tumors it: mice and rats. Respcctetl
nracurch in .!it.iitions such as the National
Cancer Instil ui.fi Fiavo used mien exten-
sively " |K:I:;IIIS suspension deci-
sion:!, for luv-i! "the Hcimiiustnitive proc-
ess is a c-i.i|iiiitiing one . . . [that]
rails for cni.(ii:uing reexauiitmtion at sig-
nificant junctures." Environmental De-
fense Fund, In.-, v. EPA, 5f/pr.-i, 150 U.S.
App.D.C. at :>.i;i. 4GS F.2.ir«l of 'rnuisp
-------
78
1300
510
\
W. 2d SKKIKg
Et !±E1 i?1""" lh< A" nnd' the Ad.
.
of major f,,,,
nogcn in the rat although there"
cations that this is so."** Tl
trator thought this caution
but, after "an intensive
flf I ha ***• " "" "" "*"rHtive of
AU n '"^"ded br the
ALJ, was WC|, .
T°
u I"" Ailminb.
that an "imminent h«z.
ard uxmteon the ground that «ho Ad.
mimstrator failed to establish « causal
connection between the „'*., of
con^r^^tr^ »'rr11^^"" »' U'C'
««- fc-o^ c«P,.incr S.IK irrjs±r£ sj
Ex. 38C. p. 3.
,„
* A.O.
M 57.
:;]
';:M.
• i
• II
. (t
ill
-------
^•—Whiaijuv.<;.-•' iiiii'iiiiin ••••! '•
„. F : ENV,IIONMENTAL •
Clh-Mai 135(1073) ^'
. 1301
for „ n.uch „ 80
of aldnn u.su,fe in 1971 » Other
pended use, may havc ^^
much as G percent of aWrin sales u»,l
aj'pmx.matcly half of the diofclrin u
Moreover, the PDA Market Basket
lainly
the human fat am
the years 1970-1972.1'
lesled
K1PA'., conclusion that tnc prohibition
i. IT Tmant 11..H ,,n,| transported to
the aerial parts of cro|)3> 3uch m
bcnns. which are rotated with corn.
Jfany of these product* are imjxjrtant
feed component* for animanls. The IXM-
licide residues arc thus incorporated, di-
«jUy and indirectly, into the milk, meal,
poultry, and soy products consumed by
numans. '
Shell sees inconsistency in EPA's ex-
emption from sust>en.sion of thu use of
•oil-ini|4anU.il uldrin/dieldrin as a termi
to the lop
- ._.., in lands typically sul>
to frequent disturbance throuel,
plowing nn,l disking'.
There is .sulistantiul cvi,
sufficient to .iup|Mrl the
nl Ie:isl where,
in* failed to come
huwinjf that no causal
exists. Shell did not even protest
evidence on causal connection in its ar-
SrAnrr°rthC,AU< Nor didit cont^
me ALJ s finding of a causal rclat'
ship in its objections filed with the Ad."
mimalnilor Tim At p. .
. • •"«• *!•*> s causation find-
T? •""'' '"'I'l'wl assumption of
Administrator's order. His failure t,
it on the point yields no basis
attack, especially in vicw of
of objection on this ground.
•D. Minor Uses
HO) Shell, FCM anH IKSHA i •
tlmt i*,* A • • UbDA claim
.tliat the Administrator haa failed to
show evidence of the existence of an
imminent ha^rd" and a causal connec-
ton for each suspended use of aldrin/di-
cMnn. They would place the burden 0
the agency to bring forth material on
each cron ?m^ «O-L .... .. . '
Br. a, 8.
v
y the suspension order. But
•t ia not necessary to have evidence on
t- i' 'u,a H|1Ccific U!MJ or arcu fn order
to be able to conclude on the boaw of
•ubrt.nlml evid,nco lhat Ulc ^ ?[
P|«t,dde] in Keneral is hazardou^ Bn"
vironmental Defense Fund. Inc. v EPA
TI2 16° U-S-A|'|>.D.C. at 130, 489 P^i
»t 1254. "Keliance on gunen,! daU eof
"..Icration of IalMniloiy oxpcrimc7u on
nnimab ot^» h,us l^n found to provide
• •ufffacni basis for an order cancelling
the reffwtrution of a pesticide. Id
Be. Ml. J.
O. 3; Shell Ex. 111. J.A. 1310.
,A.O. 3.
EPA Ex. S 7. J.A. MM 64.
3IuJJe £n .Sh°W dWdrin rosiduel d«rinB
•n«la24 pp,n. KPA Ex <7 (Dr. Kulx). .,
1261 9U ** EPA ^ S-IS.
I
•X
-
-------
I
..».'»•
•*•?
.. 80
•fc'WHAI._ IIKI'OKTKII. M 'ii. i • .
1 "„:"
turbcd
court.
Compare Shell Br. at 44-43.
F.2d a, sic
„
„,
. (I.
Defense FunU.
- E S-. EPA Ex. 71. JA 1121
•'. '-A. .092..03: tPA K.. «.'
-------
-••-• -.--..•, .' • •' 81
••• - -'•'.'
J*-tli^m ,. -"t'li.'. •. ji.' • ' ; ....
- 111 •• i «i »m IM, ^,,v. .j^fcijin^^K^j
. KNV1KON.M KNTAI/ D. P., INC. v.
Cite IM Sin K
We can Imnlly overturn the Administra-
tor's cnncliision that the alternative
were nileiiuatc on the ground that IK- did
not give tiun|ie(liiiK weight to conve-
nience.
Testimony that earlMiinato and orga-
nophospalc alternatives do not share the
pcnistencn, lipidsolubility, and biocon-
centmtion in animal or human tissues
characteristic of aldrin/dioldrin--ai,.|
thus do not pose the same cancer riak—L
BiipiiorU thu finding: that the aJlcrnur
lives are environmentally suitable.
2. Minor Unas
[16] USDA and PCM challenge the
Administrator's failure to provide exten-
sive riHk.lN!neni analysis for each rrop
and each geographical area for which
aldrin/dieldrin has huun suspended.
They fault the order on the grounds thai
it makes conclusory findings for minor
uses without discussing the contrary ovi-
'cnce ami tlmt it lacks substantial record
evidence lo support its rationale. How:
ever, the expedited nature of the suspen-
sion proceeding impost* limitations on
the de-give of detail that can be expce'crd
from the Administrator's findings at this
stage of the administrative process. A
more careful exploration of the availabil-
ity of alternatives for minor uses would
be contemplated for the final determina-
tion on cancellation «.•/ non, but we can-
not demand an extended discussion of
the evidence for every uso at this emer-
gency, provisional .stage.
The nrcord evidence a* to the relative
risks and In-ncfits of each use in i\ mixed
baff, but it provides substantial support
for the Administrator's conclusion. The
order cites California ex|ieriencc-wilh al-
ternative iRisticidcs that have proved <-f-
fcctive against Fuller's Uoxe Beetle, the
Florida citrus |iesl conlnilled by ald-
rin/dicldrin, and there is also evidence
thnt effective foliar sprays will IHI avail-
able for use should an emergency arise
during the aus|>cnsion periixl. Morcovt-r,
aldrin/dicldrin is used on less than 5 |>er-
ENVIUON.MKNTAI. IMcO.'AGCY.
cent of i hr total citrus acreage, and tho
Al J notitd that much of Unit use was a
kind <.-f "ju.-u in care" insurance, appliitl
even in (In- nlwemv ..f knowledge thnt
the ^-st ,-xisu» in tho rx-rtinent grove.
As to yt!|.!(- crops. Ll»: r.rcord indicates,
for CN.-inipl..-, that ••ff..-.-iivc registered ai-
ternalivr.-., ;ire available; that, in the
case of (.;.-,( -apples :i;iil cnmberrius, aid-
rin/dicl-irin offer tmil'.i-year protection,
so tho h«r.rfim of p:,sl applicsitioiw will
conlinu-; am| in!lt thv pn.-scnt oversu|».
ply in l>n: tranben-y i»:;1fk«;l diminislics
thi: j.r ..-;,,. .-,:(. f,f har-Miip from thu sus-
pcn::io»: i:i ivganl lo i|;:i
3. lli:nt:ifhlyr la itn Alternative
Shell prot-sf* lh:,t l.<-[.Uichlor/ddor-
dan.-, p.-.-,l.;.-;des that ili-.iiionstrate <:ard-
nog..T.i,-i'y in mice and are stored in hu-
man Iks-:.; in the same levels as ald-
rin/
-------
82
'
1304
aBain
to
SERIES'
cj. What impn-wei us about the »
l«n*on order umU-r review is UH,
' n"»'8tralf« «n»il,lc effort to
"Pinion lh!ll cm,,l,:usi«,|
£" .•*«",*«* Inmos «„<*
Pnrt,o^,ircinou,nici And hi*
» o» and f.ndin^ on tho other
matter, ,s adcuntc to wtfefv
his opin^Ll™ru± 1 W?^l°^UO m"tlCr" iH a'Hu«t« to M*
of U.e 3tntul,ly p,^ejn"tmi";:-''art- 'TC"Urt ««* '»« .1-cW-n v
-"ch^ -^^JiS-S-J- -1"-"^ - -Pri^y.
c.x-
s
jcct-on that the 'Administrative
"onrC\n?KrCquirca ri"'linjn of thc
on all the material ;«,„«,- and
lhc ol»-
sir l» '--c- safd explicitly
indeed
of
-*
«"l'«nt Broun* of objcc-
pension
preclu,lc
.t- •
think ,t ,ufnci«nl lh«
. 0,id,n« in
»urt is
th.
to thc extent of vacating thc
or rcmandinjj for further fin
thi, was not
the
B. Procedural Challenges
[19J We turn, finally
most anlcntly prcss,:d |,y
mcnt, am) aclnptal hy the n
I- era, that the EPA Order i, Ulin
2I£i«'»"«"fc.liumi in that memtK-r,
of the agency's cnforc,ment ,taff. who
39. A.O. I.
oe redeemed by resort to a detailed faauaj
B€Wt0n T*lev«'<"« Corp. v. FCC
l-m ' -- -
(19.0). ei-rt. «(«ifctl. 403 US. 9-»3 QI
2233. 20 UW.2d 701 (197.)
- Shell R. Dr. .t i
-------
83
(.4 ill
KNVIKONMKimi, J). F., INC. v.
Cltu an 310 K
were involved in the continuing cancella-
tion hearing aL the time. presented arjfu-
menu* to UK- Administrator favoring the
issuance of a Notice of Intent to Sus-
|N!iitl. Shell concedes that eoimnunicu-
lions between the prosectiloriaJ and ad-
juilicativu staff of an agency arc appro*
printo prior to the initial filing of nn
administrative complaint, hut argues
that this rule docs nol apply whero, as
here, the comrminications Uiko place
while another pli;ise of the "same case"
w underway. We reject Shell's conten-
tion.
Suspension and cancellation hearings
are separate proceedings in the respect,
criticul here, that the decisions in the
two proceedings arc mad« under differ-
ent legal standards." To the ex lent that
they are related, we do not find I his to
lie d bar to the kind of communications
engaged in here. It may hap|icn that
during the course of an agi-ncy proceed-
ing against two individuals the "proso-
:uting" staff discerns from the evidence
that proceedings should also IK: institut-
ed against, or the initial proceeding
broadened to include, a third individual.
The proseculorial.staff would not be de-
barred from consulting with the agency
head about these steps by the mere fact
that a related proceeding wiis already
under way. The same conclusion is ap-
plicable whore, there is no new party but
the emerging evidence indicates that a
new charge or a broadened charge is ap-
propriate.
Congress ha.i not accepted the view
that the |Kis.sil>ililios of unfairness re-
43. Scf Environmental Defense Fund. Inc. v.
KPA. supra. 150 U.S.App.D.C. ui .157. 4G3
F.2U at 537; Kiwiroiimcnlal Defense Fundj
Inc. v. Ruckelshnu.i. supra. 142 U.S.App.D.C.
HI 81. 439 K.2d at 591.
44. This view was proposed by Messrs. Me Far-
land. Stasoii and Vanderbilt. in their addiiion-
•I views that accompanied the Report of the
Attorney General'* Committee on Administra-
tive Procedure. Sec Administrative Proce-
dure In Government Agencies. Sen. Doc. No.
8. 77th Cong.. 1st Stss. 203 (1941).
, The only agency for. which this view was
made a legal requirement is the National La-
•tor Relations Board.
110 F.Jtf—«JV>
<:;u\ vx-
. i< ;t new
..|i;njion
:,ii... i of
KNVIKONMKNTAI. PHO. ,\fiCY. 13Q5
:u j;ie (i975>
quire prohibition of an ndniinislnilivc
structure that permits the j:»n«.« agency
U> issue the notic-e that begins a prix^ed-
ing and to make lh- uluusai.- iVicrwinu-
tion." It has acooptod a pr.'iginatic view
that the need for ••ffcctivc cy the
agency head ovi-r tnc comm- -nccincnl of
proceedings r-^uirt: an a'r.Jity tw con-
duct consultations in candor witJi nn in-
vestigative section on {]-.•: ifiestion
whether A notict nhnuld I.-.- i.^ucil and a
proceeding begun, .v-.d thi^ noi-^iilirfiand-
ing any residual [--i.sibilitii-s of unfair-
ncss.
In this cas»» llio :t|»i«r.cy rirsn-.irii.v.' the
inlernnl suparation m uincii-.iii.i j.-nivirkil
by Congross in its eon;:»i:i:-.ii;-n of f.-\ir-
n<::«i and pragma ti.-:n; th<-i-.. iy I1(J
of consultation li*>'.wuv:i :h(- ai'
"prosecutors" ami '.hu ug'.-nvy ^<:;
ccpt on the issue \vheMi- ••• u. :.-.>.
notice — whether to. ntart ;•. .-'
proceeding. Then: is no .- pli-j:
communication Ix-'.wcvn "pi-;-M'<-i;iHr"
and agency hum I rii::ir»!ini: IMC.- "\::^\ de-
cision in either the canco!!;^;. ;i procwd-
ing or the suspension priK.-^.!!!;^."
The Adminialr.-itor's i'ndicuMoro in the
Notice that he is "ix:rsya!c atiw.r---- effects'
on man and the environmi-::'." " do not
represent projudgnv-nt o.' \ho ::-..:riL< of
the decision to su-;vnd. Ti-.-- Adminis-
trator w»is merely makini: ;• •'•-.v-rir.ir.a-
tion to begin a sus|- ruion |.HH. . .!in^» un-
der § C(c)(l) of FII-V.A," :uv ..n-.iniL.I by
45. The Adniinistr:il:Vf Pn^;t-,|.ir.- At! S
U.S.C. 5 5W(d) (1970!. o.-.Jy p-..;,,' as
luition or advice ii, the "d.vtsi.-,!,.
mendcrl decision, or ,:s«ncy r.-vu-w.-
46, Notice of Imtnli'.Ni to .Sus;vnil. J.A. 70.
47. 7 U.S.C $ niMi;c)(l) (Su!>n. II. 1972).
Section 6(cXD pru^Jes thai .1 "r.oiic* (of
intent to suspemJ) sluU incliiii-.- lin('in^,s )>vr-
lainlne to the mn-stion of >imnn:ifiu n.izjrd.' "
Compare FTC v. Cinderella Career and Fin-
ishing Schools, Inc.. 131 U.$.App.UC, ^31.
338, 404 FJd I3U8. 1313 (l?tvS). whore this
court held that the FTC could isme » press-
release stating that it found "reason to be-
lieve" the law had h«rn viula'.itl soon after
the Issuance of a complaint.
: ;
'.:.:!•
fl:
• i.
! :
'•!'[•
;ii!i
• iCi:
1 I'-
ll'!''
-<*.
.$.
-------
'»;
.VIP
m
-A
S10 PKnKKAI. lll-1'OKTER, 2,|
lho prefatory finding required hy tht.
law. without prejudice in Iin.v way In in,.
consideration that would I*'riven U> ih..
•llatu».a:n_ _„„ , . «••»•» 1111.
•won record and l<» the result that
bo reached in lhu Ijtfu Of lhnl
Tho prominent* of conlinuwl
a* 4S£T •*•"'" *•«*«"
«^S!»',hk°s.u,T.Mi>>° l"!"i»e
Shell wiw alh,ilo,l 12 »f th« 15
ror ihe w^liM
,t ,,.v,| on|y 8^ nf
iya. and ,li,| ,mt tflkc ndv.-.ntnR,. of AU
I orlmnn'., offer lo ,x.Tmit the prc^nta-
t.on W,th,,,,i cro^xn.uin.aion of the
wntlun Hlutc,nc,,u, of witncssca that
eoW not !« heard orally within lhc al-
Uine.
r
"f uranscri|)l re »
exhibit, from the cancolh-
cnua.
.ntcresla in that the EPA
prosecutonaJ staff and EOF
in
in the cancellation proceeding.'*
Shell did not n,akc « s|,owinff that *
shortness of the duration of the suspen!
s.on heanntr precluded a fair dhporfL.
or that more time would have been nee.1.
-c
, a presentation in favor of
contmued registration. Indeed, although
C. Kxun>i>tiitn df
120) RDp ehaiwa| lhat lhc
eiaion lo exempt the sal,, „,„, „„. „,
wlmic stocks ,,f aldrin/dii-l Irin from lho
Kenerai suspension i, arbitrary and
pncious. EPA ,ms res^Mulcd -
•Iccision was based „„ „„ B
wat no ap|ir,*ial,lc and rnalwtienllj
ncvable st.xrks existed «t lhe t
the artier, and that any denial of
dural ririiLs u-a.s harmless error
counsel have informed us lhat EPA
prrsenlcd in January 1975 with
mules lhat 'ii '
the loui 107-1 nmoilnt of aMri^"^
will l>e available for usc in ,Q-c
•• • p>DA • t "»IO,
t-fA intends to invcstijratc the
further, an onj^oinp
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r
IBLIOGRAPHIC DATA
HEET
. Report No.
EPA-44Q/9-76-QQ8
3. Recipient's Accession No.
4. Tide and Subtitle
Criteria Documents for Aldrin/Dieldrin
5. Report Date
June 1, 1976
6.
7. Author(s)
Anonymous
8. Performing Organization Kept.
No.
9. Performing Organization Name and Address
U. S. Environmental Protection Agency
Office of Water Planning and Standards
401 M Street, S.W.
Washington, D.C. 20460
10. Project/Task/Work Unit No.
11. Contract/Grant No.
12. Sponsoring Organization Name aod Address
Office of Water and Standards
U. S. Environmental Protection Agency
401 M Street, S.W.
Washington. D. f. 20460
13. Type of Report & Period
Covered
Interim
14.
15. Supplementary Notes
16. Abstracts
This document summarizes the physical/chemical properties, toxicological
information and environmental fate and effects of Aldrin/Dieldrin, with
emphasis on aquatic behavior. From these data, criteria are developed for
the protection of aquatic life and for human exposure.
17. Key Words and Document Analysis. 17a. Descriptors
Criteria
Toxicity
Aquatic animals
Aquatic biology
Human ecology
Safety factor
17b. Identifiers/Open-Ended Terms
Toxic Pollutant Effluent Standards
Federal Water Pollution Control Act
7c. COSATI Field/Group
18. Availability Statement
Release unlimited
19.. Security Class (This
Report)
UNCLASSIFIED
20. Security Class (This
Page
UNCLASSIFIED
21. No. of Pages
22. Price
NTis-38 tnev. 10-731 ENDORSED BY ANSI AND UNESCO.
THIS FORM MAY BE REPRODUCED
USCOMM-OC B298-P74
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If the report contains a significant bibliography or literature survey, mention it here.
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rORM~NT1S-39~(RSV. 10-73) " USCOMM-OC 8283-P74
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