U.S. DEPARTMENT OF COMMERCE
National Technical Information Service
PB-254 014
Criteria Document for
DDT (DDD, DDE)
Environmental Protection Agency
June 1, 1976
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PORTIONS OF THIS REPORT ARE NOT LEGIBLE.
HOWEVER, IT IS THE BEST REPRODUCTION AVAILABLE
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BIBLIOGRAPHIC DATA
SHEET
1. Report No.
EPA-440/9-76-010
3. Recipient'* Accession No.
PB-254 Q1A
4. Title and Subtitle
Criteria Document for EOT
5. Report Date
June 1. 1976
7. Authors)
Anonvmous
8* Performing Organization Repc.
No.
9. Performing Organization Name and Address
U. S., Ehraironmental Protection Agency
Office of Mater Planning and Standards
401 M Street, S.W.
D.C. 2Q46Q
10. Proieet/Taak/Work Unit No.
11. Contract/Grant No.
12. Sponsoring Organization Name and Address
Office of Water Planning and Standards
U. S. Environmental Protection Agency
401 "M: Street, S.W.
Washington. D. C. 20460
13. Type of Report ft Period
Covered
Interim
14.
15. Supplementary Notes
16. Abstracts
This document summarizes the physical/chemical properties, toocLcological
information and environmental fate and effects of COT, with emphasis on
aquatic behavior. From these data criteria are developed for .protection
of aquatic organisms and for human exposure.
17. Key Words and Document Analysis. 17a. Descriptors
Criteria
Toxicity
Aquatic animals
Aquatic biology
Human ecology
Safety factor
17b. Uentifiers/OperfEnded Terms
Toxic Pollutant Effluent Standards
Federal Water Pollution Control Act
17e. COSATI Field/Group
18."Availability Statement
Release-Unlimited
19.. Security Class (This
Report)
]21. No. of
20. Security Class (This
Pa
age
U
NCLASSIFIED
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EPA-440/9-76-010
CRITERIA DOCUMENT
DDT (DDD, DDE)
\\
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INTRCOOCTICN
CRITERIA DOCUMENTS FOR TOXIC POLLUTANTS
Scientific rationale and criteria developed pursuant to Section 307(a)
of th<; l-X'deral Water Pollution Control Act. I'. I,. 92-500. 33 U.S. C. §§ I2f>l
et scq., (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-contaminate<
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
V
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species representative of wide geographic distribution. Chronic
studies are an important consideration in establishing criteria and require
Htudies of at least one generation, i.e., one reproductive cyrlc. 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 Q.Ql when applied to acute toxic values
is thought to provide an ample margin of safety for certain chlorinated - •
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
Y'l
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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 consumerc of ao/iatic 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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An approach to criteria development is 'to provide ample protection
of the test species on the assumption that the response of these species
will he characteristic, of other associated organisms in the ;-.:j-.ia!;-.-
environment. A number of Hp«vrir.s have burn eonsidereil 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
•v
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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ff.
DDT
TABLE- OF CONTENTS
I. Preamble. .1'
II. Chemical-Physical Properties... 10
III. Toxicolcgica'' Data... :...' 12
a. Microbes '.......14
b. Primary Producers 14
c. Aquatic Invertebrates L5
d.;. Fish......... .................19
e. Bi rds "..................................... 24
f. Mammal s.......................;........ 29
g. . Human Heal th Hazard. 36
IV. Environmental Fate and Effects. ^9
V. Criteria Formulation. 46
VI; References .'. ..'. 49
Appendix A
. Appendix B
Appendix C
Appendix D
Appendix E
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Document Appen/ii x
Consolidated DDT Hearings,
Opinion, and Order of the
Administrator of June 74,
1972. 37 ?,R. 13369
(July 7, "972} . A
Environmental Defense_?und v.
Environmenta__l Protection Acency,
^89 P. 2(5 12£i7 (D.C. Cir. 1S73). B
?adt?ra 1 Redster publication and
preamble of Subpart: D of the
Environmental Protection Agency's
("EPA") Rules of Practice for
Applications Under Sections 3 and
*S to Modify Previous Canceila-cion
or Suspension Orders, 40 ?. 3. '226',
(March 13, 'i975;. C
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.DDT
I. Preamble
DDT and its derivatives are among the most widely
distributed synthetic chemicals on earth. They are found in
soils, runoff water, airr rainwater, and in the tissues of .
animals. Basic characteristics of DDT include persistence,
mobility, and a broad range of toxicological effects. These
effects are discussed in Part II of this document, and'have
been reviewed at considerable length by the Agency and
reviewing courts in the course of cancellation and
suspension proceedings under the Federal Insecticide,
.gicide, and sodenticide Act, as amended, 7 U.S.C. 9135 et
seg, (FIFRA) . pertaining to registration, reregistration
and classification procedures. For a full background of
those proceedings, including the findings of toxicity and
carcinogenicity (including the substantial risk of cancer
with respect to human beings), the following materials are
*
incorporated herein by reference, and attached hereto.as
appendices:
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Document . " Appendix
Consolidated DDT Hearings,
Opinion, and Order of the
Administrator of June 14,
1972. 37 F.R. 13369
(July 7, 1972) . . A
Environmental Defense Fund v.
Environmental Protection Agency,
489 F.2d 1247 (D.C. Cir. 1973). B
Federal Register publication and
preamble of Subpart D of the
Environmental Protection Agency's
("EPA") Rules of Practice for
Applications Under Sections 3 and
.18 to Modify Previous Cancellation
or Suspension Orders. 40 F.R. 12261
(March 18, 1975) . C
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State of Louisiana Request for
Emergency Use of DDT on Cotton;
Statement of Reasons for the
Order and Determination of the
Administrator that Reconsideration
of the Agency's Prior Order of
Cancellation of DDT for Use on .
Cotton Is Not Warranted (March 17,
1975); Order and pet-er mi nation of
the Administrator that Rf. considera-
tion of the Agency's Prior Order
of Cancellation of DDT for Use on
Cotton Is Not Warranted (March 14,
1975); Supplement to the Order and
Determination and statement of
Reasons for the Order and Deter-
mination of the Administrator that
Reconsideration of the Agency's Prior
Order of Cancellation of DDT for Use
on Cotton Is Not Warranted (April .1,
1975). 40 F.R. 15934 (April 8, 1975).
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Federal Register
Preamble to Sutpart Part A, Part 162,
40 CFR, of EPA's Regulations for the
Enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, Pertaining
to Registrationr Preregistration and Classi-
fication Procedures, U0: F.R. 28242-28267
(July 3, 1975) . ' E
By way of brief summary of the extensive proceedings and
intense scrutiny of DDT and its properties set forth in the
above-referenced materials, on October 31, 1969, the
^viron mental Defense Fund (EDF) and other environmental
ups petitioned the Secretary of Agriculturer prior to the
existence of EPA, to cancel the registration of all
pesticide products containing. DDT and to suspend those
registrations pending cancellation proceedings because of
its health hazards. In response to this petition, USDA
cancelled uses of DDT on shade trees, tobacco, around the
home, and in aquatic areas, and requested comments on other
uses. Following litigation, the Secretary in June 1970,
made further findings of toxicity of DDT.to birds, bees, and
fish. .•'.'•'•'
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Further litigation by EOF resulted in judicial remand of
DDT proceedings to the FPA Administrator who, on January 15,
1971, issued cancellation notices for all remaining
registrations of DDT products. On September 9, 1971, a
committee of experts nominated by the National Academy of
Sciences, following a lengthy investigation, reported that
DDT posed an imminent hazard to the environment, and
recommended .that all DDT use', be rapidly phased out.
t
Thereafter EPA held lengthy public hearings between
August 17, 1971, and March 16, 1972, before a hearing
examiner.
Following these hearings the Administrator on June 1U,
1972, cancelled all DDT registrations except those for
/
public health and agricultural pest quarantine use. See 37
F.R. 13369, (Appendix A).
In his decision the Administrator stated that he was
"persuaded...that the Ibpg-range risks of continued use of
DDT for use on cotton and most other crops is unacceptable
and outweighs any benefits," 1972 Order, 37 F.R. 13369.
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The Administrator found that "once dispersed, DDT is an
uncontrollable, durable chemical that persists in the
aquatic and terrestrial environments". 1972 Order, 37 F.R.
13370 par. Ill A.. He concluded that DDT was "highly
volatile" (37 F.R. 13370 h. 16) and is transported by drift
during aerial application" as well as by runoff (Id., n.
13). He further found that, "Given its insolubility in
water and its propensity to be stored in tissues, it
collects in the food chain- and is passed up to higher forms
of aquatic and terrestrial life.*1 (Id. at' 13370, par. Ill,
A, 1). The Administrator also found that DDT "can persist
in the soils for years and even decades" (Id. at 13375, par.
A, 1); that it "can persist in aquatic ecosystems" (Id.
at 13375, par. II, A, 2) ; and that "it is occasionally found
in remote areas or in ocean species, such as whales, far
from any known area of application" (Id. at 13370-71). As a
result of its persistence and mobility, the Administrator
found that DDT is "concentrated in organisms and transferred
through food webs" (Id. at 13375, par. Ill, A,1) ; that DDT
"accumulation in the food chain and crop residues results in
human exposure" (Id. at 13375, par. Ill A, 2); and that
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••^uman beings store DDT" in their tissues (Id, at 13375,
par. Ill, A, 3). .
The Administrator also found that DDT poses hazards to
• ' ? ' '
birds, fish and other animal life:
"1. DDT affects phytoplankton species' composition and the
natural balance in aquatic ecosystems.
2. DDT is lethal to many beneficial agricultural insects.
3. DDT can have lethal and sutlethal effects en useful
aquatic freshwater invertebrates, including arthropods
and molluscs. .
U. DDT is toxic to fish.
5. DDT can affect the reproductive success of fish.
6. DDT can have a variety of sublethal physiological
and behavioral effects on fish.
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7« Birds can mobilize lethal amounts of DDT residues,,
8. DDT can cause thinning cf bird eggshells and thus
impair reproductive successo" {Id0 at 13375 IV^ A* 1-8)
With respect to human health, the Administrator found
that "DDT causes tumors in laboratory animals"; -that "there
is some indication of metastasis" of such tumors; that
"tumor induction in mice is a valid warning of possible
carcinogenic properties", and that there are 8?no adequate
negative experimental studies in other mammalian species"
and that for obvious reasons one cannot run experiments on
*n beings to gather such epidemiological data,
Accordingly, the Administrator found that DDT poses a cancer
risk to man.' (Id. at 13375, par. IV, A, 9; IV, E) .
The Administrator's cancellation order was upheld by the
U.S. -Court of Appeals for the District of Columbia circuit
in 1973 (Appendix, B) . Subsequently in the spring of 1975
the State of Louisiana requested reconsideration of the 1972
Order so as to permit emergency use of DDT on cotton 0 In
denying that request, the Administrator found 'that
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Scientific data gathered since the 1972 Order strengthened
-and confirmed the Agency's prior determination that pDT is
highly toxic to a wide variety of animals and organisms,.
that it is highly persistent in the environment, that it
poses a serious risk of cancer to. man, and that humans and
other organisms should not be subjected to the hazards pcsed
by its further release into the environment. (Appendix D;
See e.g. 40 F.R. 15939-15941, 15950).
• . f ' '
Notwithstanding the cancellation of most uses of DDT
under FIFRA, pesticides utilizing DDT will continue, to be
i
croduced and formulated in this country as long as demand
them continues in other parts of the world. Therefore,
limits that protect all receiving water uses must be placed
on concentrations of DDT in effluents of plants that produce
and formulate these pesticides.
For the reasons hereinafter set forth a criterion of
0.001 ug/1 for DDT is recommended. All human contact should
be avoided, due to the demonstrated carcinogenic activity of
DDT.
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*•-- Chemical-Physical Properties
Dichlorodiphenyl trichloroethane {DDT; 2,,2-bis-(p=
chlorophenyl) - 1> 1, 1-trichlorcethane) is a whit-3
crystalline powder with a melting point of 108,5 to 109° cr
a boiling point of 185° Cff a vapor pressure at 20° c of 1«9
X 10-7 mm mercury, and a low solubility in water (1 ug/1).
Since DDT is almost insoluble in water and is readily
sorbed, it tendsr in aquatic systems to associate with
particulate material. DDT exhibits a strong affinity for
fatty tissue and, when biologically consumed, accumulates in
i
lipid fraction of aquatic organisms. Incorporation cf
DDT into aquatic organisms may occur from direct contact
with DDT-containing water or through ingestion of
particulate matter containing DDT (1). Buildup cf DDT
occurs between' lower and higher members of the food chain
« •
resulting in increasing harm to. fish and birds (2, 3} «
A degradation of DDT to ODD (I, l-dichloro-2, 2-bis
(p-chlorophenyl) ethane) occurs in the anaerobic zones of
aquatic systems (U, 5). A study in 1973 of the degradation
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o~ DDT in the anaerobic, sediments was conducted by treating
fields with DDT and then flooding. Before flooding, the
soil rapidly became anaerobic (redox-potential dropping
below -150 mV). The DDT concentration rapidly decreased
from 8.1 ug/g to 0.5 to 1.6 ug/g with a concomitant increase
in ODD concentration of from 0 to'"'«».. 2 to 5.6 ug/g. Rates of
appearance of DDD and disappearance of DDT were slower in
control plots not receiving the prganic material, indicating
that an anaerobic process was responsible for the conversion
of DDT TO DDD which also can be transformed to DDE (10, 11).
DDD, produced by the dechlorination of DDTr is also used in
agriculture and differs only slightly in its toxicological
perties and biological accumulation characteristics.
DDE, produced by the dehydrochlorination of DDT, is closely
related though not used in agriculture (3UJ. Thus, for the
purpose of this document the three compounds are considered
collectively, .arid the references to DDT are applicable
generally to DDD and DDE as well.
' When DDT was applied at 10 to 20 Ib/A, it was found in
the soil from four (6) to ten (7) years later. Vihen applied
at a rate of 100 ppm (22H kg/ha to a depth of 38 cm) to
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sandy loam soil, 39 percent of the DDT remained after 17
years (8). Soil in a Maine forest treated with DDT at 1
Ib/A showed little decrease in residues during the 9 years
after application and the investigators suggest that
residues may persist for 30 years (9). Once applied to
soil, DDT migrates to water in association with suspended
sediment (12) .
III. Toxicological Data
Toxic effects resulting from the presence of DDT 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 DDT on
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individual organisms and their food chains and is recognized
as such by the scientific community.
It should be noted that the LC50 values reported for
static tests are likely to be substantially higher than LC
values found using flow-through bioassays. For instance.
Earnest in 1970 (87) found a 96-hour TLm of 0.86 ug/1 of DDT
for Korean shrimp, Palaemon macrodactylus, using a static
f
bioassay, and a TLm of 0.17 ug/1 using an intermittent-flow
bioassay. This may explain why Katz in 1961 (88) reported a
96-hour TLm of 11.5 ug/1 for chinool< salmon, Oncorhynchus
u«;havjfy_tscha, in fresh water, while Earnest calculated a
jLue- of 4.66 ug/1 for the same species in an intermittent-
flow bioassay. These data suggest loss of toxicant in
static bioassays. Static tests in which dissolved oxygen
and toxicant concentrations 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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: A. Microbes
There is a paucity of information on the effects of DDT
on microhial systems. A study in 1974 indicated that the
Escherichia coli and Bacillus fraqilis when grown in a
medium containing 10 ug of DDT exhibited differential
responses. The E. coli strain yield was higher than in the
controls while the B. fraqilis yield was lower than in the
controls. The formation of DDD was observed in both qulture
media (13) .
B. Primary Producers
Reduction of photosynthetic activity has been reported
to occur in the presence of DDT. Phytoplankton test
L
cultures were exposed to different concentrations of DDT for
20 to 24 hours, with 14 hours of light and 10 hours of
darkness. After this exposure period, cl* labeled
bicarbonate was added and the algae illuminated for an
additional 4 to 5 hours. The amount of carbon fixed by
photosynthesis was determined by radio-assay of the filtered
cultures. The effects of DDT exposures on photosynthesis
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were determined by comparison of the rate of photosynthesis
of DDT-exposed and controlled populations* The
phytoplankton populations exposed to levels as low as 100
uq/1 fixed less CO than the control populations. This
suggests that reductions in productivity at DDT
concentrations as low as 100 ug/1 may be expected (14)•
C. Aquatic InverteLraf's
Results of static^bioassays conducted with DDT on
various invertebrates are shown in Table 1 which relates
exposure time and LC50 values for the invertebrate
anisms. It can be seen that as exposure time increases
sensitivity also increases.
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TABLE 1
LC50 Values for Various Arthropods to DDT.
Arthropod species. Exposure Time (hrs) LC50 (ug/1) Ref.
Scud (Gammarus lacustris) 24 4.7 16
" » " ' .48 2.1 16
>
" » •• 96 1.0 16
f
Stonefly (Pteronarcys californica) 24 41.0 18
'• " • « 48 19.0 18
^ ii n 96 7.0 18
" (Pteronarcella badia) 24 12.0 18
w ". 48 . 9.0 18
" » ' " 96 1.9 18
11 (Claassenia sabulosa) 24 16.0 18
" " » • 48 6.4 18
" 11 M 96 3.5 18
Gammarus lacustris is more sensitive to DDT stress as
the ambient water temperature is increased. It has been
demonstrated that as the temperature increases from 40°F to
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70°F the 2U-hour LC50 decreases from 12 ug/1 to U.7 ug/1
'16).
Additional studies comparing the toxicity of DDT and of
DDD to freshvvater invertebrates are shown in Table 2.
Table 2
Comparison of the
96-hour LC50 of DDT and DDD
for Freshwater Crustaceans
96-hour LC50
Species DDT DDD REF.
Gammarus lacustris
Gammarus fasciatus
Palaemonetes kadiakensis
Asellus brevicaudus
Orconectes nais
1.0 •• 0.64 15
0.8 0.86 15
2.3 0.68 15
U.O 10.0 15
0.2U 15
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Marine invertebrates generally exhibit the same range of
sensitivities to DDT as freshwater invertebrates, as seen in
table 3. ' • \
Table 3
\
\
i
96-hour LC50 Static Bioassay for
Toxicity of DDT to Marine Invertebrates (85)
LC50
Species (ug/1)
Sand shrimp (Crangon septemspinosa) ' 0.6
Grass shrimp (Palaemonetes pugio) • 2.0
Hermit crab (Pagurus longicarpus) 6.0
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A 28-day flow-through bioassay for the pink shrimp
Penaeus dnorarum resulted in a TL50 of 0.12 ug/1 (76).
Fiddler crabs, Uca pugilator, fed plant detritus
containing 10 ug/g DDT became disoriented and lost
coordination and equilibrium (22).
D. Fish
The available data on fish demonstrate that DDT is toxic
to many species. The sensitivity of fish and the hazards
from disruption to their food chain by DDT have been known
least since 1944 (24). The high toxicity of DDT to
goldfish was described in 1944 (25) and deaths of young fish
in waters sprayed with DDT were reported in 1946 (26).
The LC50 values of DDT tested against various species of
freshwater fish are shovm in Table 4.
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Table H
Toxicity of DDT to
Various Freshwater Fishes (27)
(Static Bioassay)
LC50
Fish Species ug/1
Largemouth bass (Microoterus salmoides) 2
Brown trout (Salmo trutta) 2
Coho salmon (Oncorhynchus Kisutch) n
Redear sunfish (Lepomis microlophers) 5
Black bullhead {Ictalurus miloe) 5
1 Rainbow trout (Salmo gairdneri) . 7
Eluegill (Lepomis macrochirus) 8
Yellow perch (Perca flavescens) 9
Carp {Cyprinus carpio) 10
Channel catfish (Ictalurus punctatus) 16
Fathead minnow (Pimephales proirelas) 19
Goldfish (Carassius auratus) 21
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Cutthroat trout, Salmo clarki, were exposed in
laboratory studies for 30 minutes once a month for one and
one-half years to nominal DDT levels of 10 ug/1, 30 ug/1,
100 ug/1, 300 ug/1 and 1,000 ug/1. At the end of the
experiment period, from 50 to 75 percent of the 636 fish in
each group were dead at the three, highest concentrations of
DDT (i.e., 1,000 uq/1, 300 ug/1 and 100 ug/1). The number
and volume of eggs produced by the trout were not reduced by
these levels of DDT, but mortality amorg sacfry was higher
at the 300 ug/1 and 1,000 ug/1 levels (28).
Some species of fish are extremely sensitive to DDT.
!
r example, the extrapolated LD50 dosages for young chinook
*
cuid coho salmon, were 27.5 and 64 ug/kg/day, respectively.
The chinook salmon, Oncorhynchus tshawytscha, appeared to be
•two to three times more sensitive to DDT than were coho
salmon (29). When Atlantic croaker, Micropogon undulatus,
were fed 2.75 ug of DDT per gram weight of fish per day for
67 days, the accumulated DDT resulted in mortality beginning
on the 1Uth day and continuing until all fish were dead by
the 67th day (30).
-------
22
I
Acute toxicity values of DDT to some estuarire fish are
seen in Table 5. Estuarine species exhibit sensitivities
similar to those seen in freshwater species.
-------
23
Table 5
Toxicity of DDT to
Various Estuarine Fishes (84)
(Static Bioassay)
• 96-hour LC50
Test Species , ug/1
Mummichog (Fundulus hetercclitus) 5.0
Striped killifish (Fundulas majalis \ I.Q
Atlantic silverside (Menidia menidia) o.A
Striped mullet (Mugil cephalus) . o.9
American eel (Angviilla rostrata) 4..Q
Bluehead '(Thalassoma bifasciatum) 7.0
Sheepshead minnows, Cynrinodon varieqatus, that survived
DDT exposures which killed most of the fish tested, tended
to have offspring more sensitive to DDT than those of the
control group. Abortion of young was observed among
mosquitofish, Gambusia affinis, that survived exposure to
-------
organochlorines at dosages that killed a portion of the
group (35) , ,
Fish survive relatively high DDT residues in their body
fats, hut residues concentrated in the eggs of mature fish
may be lethal to the developing fry. .Burdick in 1964 (33)
reported up to 100 percent loss of lake trout fry,
Salvelinus namavcush, when residues of DDT-DDD in the eggs
exceeded 4750 ug/kg. Higher losses were-not observed ^since
experiments were terminated when mortality reached 50
percent.
DDT can adversely affect fish in an indirect manner by
.reducing or destroying important elements in the fish food
.supply (80).
E. Birds
A study of the acute oral toxicity of technical grade
DDT to birds gave the results shewn in Table 6 (36), The
birds in this study were fed diets containing varying
-------
25
amounts of DDT for 5 days followed by 3 days of food
containing DDT.
-------
26
Table 6
Toxicity of DDT -to Birds
When Incorporated into Feed (36)
Weight (mean) 5-day LC50
Bird (g) (mg/kg of feed)
Blue Jay 72.& 415
House Sparrow 26.7 415
Cardinal 37.9 t 535
Eobwhite cfuail (wild) • 1U3.8 1170
Bobwhite quail (farm) . 202.4 1610
Six-week>old male and female broad-breasted white
turkeys were fed diets containing 264.6 ppm (mg/kg) o, p1
DDT or p, p1 DDT for 7 or 15 weeks (37). This dosage did
not cause any 'detectable alterations of blood pressure or
gross tissue structure changes .of the heart, aorta, liver,
testes, oviduct, ovary, thyroid or kidney. In addition, no
plasma changes were seen with regard to cholesterol, calcium
levels, albumin-globulin ratio, or lipoprotein patterns.
-------
27
A study in which DDT was administered to birds orally in
4
gelatin capsules gave the LD50 values shown in Table 7 (38).
-------
28
Table 7
Acute Oral Toxicity of DDT to Birds (38)
Bird Sex
Mallards F
Pheasants F
European quail M
Pigeons MSF
Lesser Sandhill MSF
Cranes
LD50 (single dose)
Age (mg/kg body wt.)
3 months 2240
3-4 months 1296
2 months 841
> HO'OO
Adult > 1200
The 30-day mean lethal dose for mallards was 50
mq/kg/day. Adult mallards fed 100 ppm DDT in the diet
showed a median survival time of about one year. In a 90-
*
day feeding study, 30 ppm DDT in the diet was not lethal to
either mallards or bobwhite quail.
DDT does not appear to be significant in the acute
poisoning of bird species because of the large dosages
-------
29
required to cause death. While acute toxicity is not likely
'to be significant, there is considerable evidence to suggest
that DDT decreases the reproductive capacity of some bird
species. Studies were made of mallard ducks' reproductive
ability as a function of dietary DDT, ODD, and DDE (39).
DDT at the 25 ppm dietary level induced thinning of shells
and reduced duckling survival. ODD, however, did not
interfere with reproduction. A CDT-DDE mixture (20 ppm
each) in the diet, caused eggs-hell thinning and increas-ed
embryo mortality (39).
F. Mammals .
•'";'. ; ' • - '..'. \
The acute toxicity of DDT to mammals is low. Animal
experimentation conducted over 20 years ago established that
the median lethal dose of DDT by the oral route in mg/kg
body weight is 150 to 250 for mice and rats, 150 to 300 for
cats and dogs, 300 to 500 for guinea pigs and rabbits, over
200 for monkeys, over 300 for cows and horses, and 1/000 for
sheep and goats (40). All subsequent experimentation and
use experience has confirmed the early finding of low
mammalian acute toxicity of DDT.
-------
30
In an experiment in 1972, squirrel monkeys, Siorcr.ri
sciureus, were fed py p9 DDT in peanut oil at le.vels of 50,,
Se OoS,,, 0.05 and 0 mg/kg body weight/day (43). The animals
that, were fed 50 mg/kg body weight/day. exhibited initial
clinical signs of toxicity (staggering, weight, loss,,
weakness, and loss of equilibrium). After the initial
toxicity symptoms in the group fed 50 mg/kg/day, the monkeys
began to recover. However, during the fourth week, four of
the experimental animals in the high dose group died. ' The
remaining two monkeys died during the 9th'and 1Uth week of
the experiment. None of the monkeys fed 5 mg/kg/day of EOT
died as a result of DDT intoxication,, Some were sacrificed
intervals and no discernible effects on hematological
values of plasma enzyme levels appeared,
A.study employing albino rats determined the 24-hour
LD.50 of technical grade DDT to be 118.7 mg/kg of body
weight. The chronic effect of 100 ppm DDT in the diet was
also investigated for a 6-month period. The 100 ppm level
did not adversely affect the mortality rate and growth of
the rats. No changes in physical behavior were noted. The
only significant effects were an increase in liver weight
-------
31
and a shortening of the pentabarbi tone- induced sleeping time
in the DDT fed rats
New Zealand white rabbits were fed DDT in corn oil at
the rate of 50 mg/kg/day during the seventh, eighth, and
ninth day of gestation. Fifty-seven percent of the treated
rabbits delivered prematurely (less than 28 days of
gestation). DDT increased the number of resorption sites,
r
and the weight of fetuses frvm the DDT- fed rabbits was
significantly lower. None of the control animals delivered
prior to 30 days of gestation. The same levels of DDT fed
"HI days 22 and 23 of gestation showed no effects (15).
A dose of 12 mg/kg daily in beagle dogs resulted in
subnormal reproductive activity. It was concluded from
these results that the feeding of DDT induced lasting
metabolic changes reflected in delayed estrus, reduction of
libido, stillbirths and lack of mammary development with
reduced milk production which was responsible for a high
mortality rate among the offspring (18,
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32
Gene-tic damage has also been shown to result from DDT
inqestion. The administration of 100 to 400 ppm in the diet
of mice resulted in an increased incidence of chromosomal
abnormalities in the form of deletions, stickiness, and
rarefy, ring and metacentric chromosomes (50). This study
indicated that chromosomal damage to mice occurred
frequently at dosages of 150 ppm or higher (LD50 is 550
ppm) . Since the induction of chromosomal damage is often
associated with mutagenic occurrences in mammals, DDT is a
potential mutagen. Further evidence of the mutagenic
potential comes, from in vitro studies on cell lines derived
from the kangaroo rat, where concentrations as low as 10
'1 of p, p* - isomers of DDT, ODD and DDE in the medium
caused some damage in the cells (51).
- s
In a study in 1965 of the carcinogenicity of 130
pesticides and related compounds including DDT, it was found
that DDT significantly increased the incidence of hepatorcas
in two strains of mice. When p, p' DDT was administered by
gavage (i.e. stomach tube) at a dose of 46.4 mg/kg of body
weight and at a level of 140 ppm in'the diet (140 mg/kg
food), the incidence of hepatomas in 36 treated males was 50
-------
33
percent, and 1t» percent in 36 treated females. The non-
treated controls exhibited a 7 percent incidence for a group
of 169 animals, both male and female (46).
Studies were undertaken to determine the effect, of DDT
exposure over several generations. Mice (BALD/c strain)
' • -, ' . i
were fed 2.8 to 3 ppm DDT for six months and observed for an
additional 20 months. ?. progressive increase in tumors from
the second generation onward v/as seen. In the test gr*oup of
68U mice, tumors developed at an incidence greater than in
the control group. The DDT-fed group showed a greater
Incidence of.leukemia and malignant tumors than the controls
the F1 and Fz generations with increasing incidence in
later generations (52). The accumulated DDT content in the
fatty tissue of the experimental group amounted to 7 to 11
> -.
mg/kg.
It is extremely sigificant to note that the value for
concentrations of DDT in the fatty tissue of mice is on the
same order as the DDT levels in the fatty tissue of urban
populations of human beings (53),
-------
3 a
In a definitive study by Tomatis e_t alB in 1972,, using a
second strain of mice (CF-1) given DDT in the diet at
concentrations of 2g 10^ .50 and 250 ppm for the entire life
span for two consecutive generations^, hepatic tumors
developed at all concentrations'in the male populations.,
Female populations exhibited a slight increase in numbers of
hepatic tumors following exposure to 10 and 50 ppm with a
marked increase at the 250 ppm concentration* The age at
death with liver tumors and the incidence of liver tumors
was DDT-dose-related in the exposed mice (54)„ These
results support earlier findings which used p, p' DDT on
"till another strain of mice (46).
In November 1973 a team of Russian scientists reported
the results of a multi-generation DDT feeding study in which
two*groups of A-strain mice were fed 10 and 50 ppm DDT in
the parent generation while five succeeding generations were
fed 10 ppm. DDT caused a significant increase in lung
tumors at both feeding levels in the parent groupse All of
the five succeeding generations showed an increase in lung
tumors over control animals; the increase was significant
-------
35
statistically in the second, third and fourth generations
fed 10 ppm, the only dose so tested (90J . The. finding that
CDT induced carcinogenicity at a site other than the liver
supports the results of an earlier report by a Hungarian
team which showed DDT to cause a progressively significant
increase in leukemia and other malignant tumors at several
different sites in the second through the fifth generations
of mice fed approximately 3 ppm of CDT in the diet (52).
.'"••-.. • ' ~ /
In March 197U the first study of the effects of the
long-term feeding of p,p* DDE, the principal DDT metabolite
found in all humans and in the highest quantity of all of
"a metabolites, was reported. At the only feeding level
tested (250'ppm), p,pf DDE was shown to be an extremely
potent liver carcinogen in both male and female mice, but
particularly in females in which there, was a 9815 incidence
of tumors compared to only 1% in the control animals.
Another DDT metabolite, p,p' DDD fed at the same single
»
feeding level caused a significant increase in lung tumors
(91).
-------
36
G. Human Health Hazard
Very few cases of acute DDT poisoning have occurred in
man and there is no well-documented case of fatal DDT
poisoning.
- . . .. •>
The pharamacological effects of oral doses of DDT in man
have been studied. There are some differences in the doses
*
reported to produce various effects, but the types of '
changes and their duration were.the same in all studies.
The lowest oral doses of DDT reported to produce effects in
*
.man were those used by Velbinger (42). In that study, oral
oes of 250 or 500 mg per man in suspension or oil solution
produced no effect except a variable, slight.disturbance of
the sensitivity of the mouth. Doses of 750 or 1000 mg in
solution led to disturbances of the sensitivity of the lower
part of the face, uncertainty of gait, malaise,
hypersensitivity to contact, cool moist skin, but no changes
in reflexes. Discomfort reached a peak in about 6 hours. A
dose of 1500 mg in oil solution produced prickling of the
tongue beginning about 2.5 hours after ingestion.
Disturbance of equilibrium, dizziness, confusion and tremors
-------
the extremities gradually increased. A peak reaction
characterized by malaise, headache, fatigue, and delayed
vomiting was reached about 10 hours after ingestiori and
recovery was almost complete in 24 hours.
•' -
As previously discussed, experimentation with mamnals
has led to the conclusion that DDT poses a substantial human
health hazard.
In 1972,"former EPA Administrator Ruckelshaus made the
Ttual finding that "DDT is a potential human
carcinogen." As the basis for this finding the
Administrator cited the fact -that: "Laboratory tests.
have...produced tumorigenic effects on mice when DDT was fed
to them at high levels" (Appendix D). The laboratory tests
referred to were cited as the Bionetics study in which mice
were fed 140 ppm of DDT and the Lyons study (at that time
incomplete and still in progress) in which "increased
hepatomas (liver tumors) were noted in male and female mice
fed DDT at 250 ppm."
-------
38
Nearly five months after the 1972 Order and some nine
months after the close of the DDT hearing, the first final
report of the Lyons study, referred to as "still in
progress" in the 1972 Order, was published. That report not
only showed DDT to cause a significant increase in liver
tumors in the first generation of mice fed 250 ppm DDT, as
noted in the 1972 Order, but also revealed that a similar
significant increase in liver tumors was shown in two
generations of male mice fed 50 ppm, 10 ppm and 2 ppm, the
• . r
lowest, known dosage of DDT ever tested (54) .
In September of 1973, the final results of the Lyon
•
•tudyf extended to six full generations of mice (nearly
,000 animals) fed DDT at 2, 10, 50, and 250 ppm levels,
were published. The findings in the succeeding four
generations of mice confirmed the results reported in
October 1972 in the parent and first generation treatment
group. In the male mice in all six generations DDT caused a
significant increase in liver cancer at every treatment
level including 2 ppm, the lowest dosage tested (92).
-------
Environmental Fate and Effects
Once dispersed, DDT is an uncontrollable, durable
chemical that persists in the aquatic and terrestrial
environments.,. It can evaporate from crops and soils and can
be transported adsorbed to eroding soil particles. DDT can
persist in the soil and in aquatic ecosystems and is
occasionally found in areas or in biota far from any known
area of application. As a result of its persistence and
mobility DDT accumulates in \:he food chain and crop residues
resulting in exposure of humans who also store DDT in their
tissues (Appendix A).
Movement of DDT into the aquatic ecosystem is critical
»ice, once in water, this pesticide is persistent and. .
remains toxic. Entrance into water may be accomplished by
. . • i
physical, chemical or biological transport. It is virtually
impossible to identify all the various physical factors
- • •
acting upon persistent organic chemicals such as DDT (56).
However atmospheric transport (55) and washing of
contaminated soils would be the ^most .frequent routes.
The relatively low solubility of DDT in water and its
hiqh lipid solubility tend to allow for removal from the
-------
vater column by accumulation in plant and animal fats0 Once
applied to soil, DDT migrates to water (12)„ It is very
stable, and its vapor pressure results in loss to the
atmosphere allowing for atmospheric transport (57).
DDT accumulates in sediments, living organisms and
particulate matter. Eventually, the DDT tends to reach the
water surface where it will co-distill with water to again
•' ' ' ' f .
enter the atmospheric cycle. When in air and exposed to
ultraviolet light in the region of 290 to 310 nanometers, it
will convert.to ODD and to DDE. After 4 days of
irradiation, as much as 48 percent of DDT will convert to
DE and 2 percent to DDD (58).
Eioaccumulation of DDT begins at the very lowest trophic
level. Yeast cells have been shown to take up DDT (59, 60)„
Subsequently fungi and bacteria, including species of
Streptomycetes, Bacillus, Serratea and Aqrobacterium have
been shown to bioaccumulate this pesticide (59). The
phytoplankter, chlorella, has been shown to accumulate DDT
from water (60). Thus both microbial populations and
phytoplankton, the very basis of all food webs and hence
-------
41
among the most important organisms to be protected, initiate
the bioaccumulation process of DDT.
* V . '
Use of DDT at 100 ug/1 for control of black flies in
Labrador resulted in fauna! changes, caddisfly larval
populations were reduced to zero or near zero at all
stations receiving the treatment, and the same was true for
stonefly and mayfly larva. The DDT also caused mortalities
. ' ' • /
in eastern brook trout, Salvelinus fontinalis, by
contamination of fish foods abpve maximum tolerance levels.
No significant short-term fish mortality due to direct
ntact was observed (21). .
Bioaccumulation of DDT in higher life forms is better
documented than for microbial species. Invertebrates have
been shown to accumulate DDT some 70rOOO times the level in
water. The oyster, when placed in flowing sea water
containing 0.1 ug/1 will concentrate DDT up to 70,000 times
in its tissue after 40 days (63). The hooked mussel,
Brachidontes recurvis and the hard shell clam, Mercenaria
mercenaria, both have been shown to accumulate DDT at
-------
42
factors of 1,260 times from 0.1 ug/1 to 6,000 times from 1
ug/1 respectively (63, 61) ..
Male and female lobsters, Homarus americanus, accumulate
DDT in their flesh. Females also accumulate DDT in their
eqg masses. The concentration found in the flesh of
untreated lobsters was 1 ppm, which represents a 10- to 100-
fold concentration factor above that of their natural sea
water (65). The pink shrimp, Penaeus duorarum, has been
shown to effect a 1,500-fold concentration of DDT in three
weeks when the water concentration was 0.1U ug/1 (76).
Residues of DDT were found to reach a level of more than
13 Ib/A in a Long Island saltmarsh. In sampling of the
marsh and the organisms present in the water, the
concentration of DDT was estimated to be 0.05 ug/1 in the
water, while in plankton the level was UO ppb. The highest
concentrations were detected in the scavenging and
carnivorous fish and birds. The. birds were reported to have
10 to 100 times higher DDT levels than the fish (67)'. When
applied directly to estuarine waters, DDT has been shown to
be rapidly absorbed by phytoplajikton. It was observed that
-------
43
residues in the' food web increased from a level of 1 ppb in
water to 70 ppb in phytoplankton, 15,000 ppb in fish and
800,000 ppb in the porpoise
Samples removed from a tidal marsh habitat in Florida
treated with 0.2 Ib/A of DDT were found to contain the
following levels: surface water and ditch, 0.3 to 4.0 ppm;
sediment samples, up tc 3.35 ppm (dry weight):.; vegetaticn,
up to 75 ppm (dry weight) ; ana in fish, levels ranged /from 4
3 89 ppm (wet weight) (69).
Sediments in Lake Michigan, on a wet weight basis, have
jn found to average 14 ppb DDT and DDE. Examination of
the amphipodj Pontoporeia af finis, in Lake Michigan for DDT
levels demonstrated a concentration of 410 ppb DDT and its
metabolites, i.e. a 30-fold concentration factor. Fish
removed from the lake had levels up to 10 times that found
in the amphipod while breast muscle from gulls averaged 27
times that of the lake alewives. The gull fat had a
concentration of 2,441 ppm DDT (3). Subsequent studies on
DDT levels in lake trout, Salvelinus namavcush, taken frcm
• ' * ' - • •
southern Lake Michigan from 1966^1970 averaged 18.1 ppm in
-------
.44
fish 55.8 to 68.4 cm long. Lake trout, S«. namaycushg taken
from Lakes Erie (2.2 ppm) and Superior (4.4-ppm) generally
had lower levels of DDT in their flesh (70)„
In the laboratory, rainbow trout, Salmo gairdneri, were
found to accumulate greater amounts of DDT with an increase
in temperature. When exposed to a concentration of .13 -
.17 ppb DDT, levels of 37,600f 59,300 and 68,200 ppb were
found in the fish at temperatures of 5°C, 10°c, and 1S°C,
respectively (71). In ponds containing 20 ug/1 DDT, rainbow
troutj S- oairdneri, black bullhead, Ictalurus miloe, and
crayfish, Orconect.es nais, were found to accumulate DDT to
els of 4150 ppb, 3110 ppb and 1470 ppb respectively (68).
Studies using brook trout, Salyelinus fontinalis, have
shown that a major source for accumulation of DDT can be the
food web rather than uptake from water (72). Thus the fact
that the amphipod, Daphnia magna, can concentrate DDT 16,000
to 23,000 times in water within 24 hours is important (73).
In an 'effort to precisely determine the fate of DDT, ODD
and DDE in an ecosystem, a laboratory model was constructed
-------
us
utilizing a terrestial-aquatic interface and a seven-element
food chain. Addition, of DOT to the system simulated an air
application rate to land of 1 Ib per acre. It was found
that DDT was accumulated in mosquito larva, snails and fish
as either DDT, ODD or DDE at factors ranging from 10,000 to
100,000 (74). Hence DDT and its toxic metabolites have been
shown to accumulate in aquatic -food chain organisms, thus
becoming available to higher carnivores and man*
-------
46
V. Criteria Formulation
A criterion of 0.001 ug/1 is recommended for protection
of aquatic lifee
DDT in water has been shown 'to be acutely toxic to
aquatic invertebrates at 0.12 ug/1 (84). DDT also has been
observed to accumulate in fish tissue to levels two million
• • -'
times those of the ambient water (77). Mice exposed to 2 mg/kg"
of DDT in their feed (the lowest dose tested) developed
nepatic tumors (46). Recognizing that 2 mg/kg of DDT in a
diet has been demonstrated to cause tumors in mice, the
concentration of DDT in aquatic organims should be less than
2 mg/kg to protect consumers of aquatiq organism-?. Since
bioaccumulation by factors as high as two million has been
demonstrated (77), a level of .001 ug/1 in water could
produce concentrations as high as 2 mg/kg in fish flesh.
Thus, even at a water concentration of .001 ug/1 some
adverse effects might be expected among animals preying on
aquatic organisms. '
-------
47
The 28-day LC50 for the pink shrimp, Penaeus duorarutn,
was reported to be 0.12 ug/1 (84). Use of an application
v.- •
factor of 0.01 to assure the safety of this species and any
others which may be equally sensitive, results in a
criterion of 0.001 ug/1 for the protection of aquatic life.
• In .man, tissue concentrations can reach levels which
threaten adverse physiological reactions (42), including the
*'••-.
potential for carcinogenesis. Since there is no
demonstrated "no effect11 level for carcinogens, and in light
of the bioaccumulation potential of DDT, all human exposure
should be avoided. •
-------
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f
14. Guenzi, W.D. and W.E. Beard, 1967. Anaerobic
,-
degradation of DDT to DDD in soils. Science, 156:
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. • /
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/•
Nash, P.G.. and E.A. Woolson, 1967. Persistence of
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• -. " '
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50
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•
m. Ware, G.W. and C.C. Koan, 1970. Interaction of
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51
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s -
18. Sanders, H.O, and O.B. Cope, 1968. The relative
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*
species of stoneflies. Limnol. oceanog., 13: 112.
•
19, Sanders, H.O. and O.B. Cope, 1966 . Toxicities of
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Trans. Amer. Fish. Soc., 95: 165.
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52
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•
crabs. Science, 164: 576.
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•
1 1
blu;e crab and factors affecting mortalities. South
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/
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•
Ellis, M.M., B.A. Westfall, M.D. Ellis, 1944.. Toxicity
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53
.. Allison, 0., D.J. Kallman, O.B. Cope, C.C. Van Valin,
1963. Insecticides: Effect on cutthroat trout cf
repeated exposure to DDT. Science., 1U2: 958.
29. Buhler, D.R.., M. E., Rasmusson, and W. E. Shanks, 1969.
. Chronic oral DDT toxicity in juvenile coho and
Chinook salmons Toxicol. Appl. Pharmacology, 14:
535.
30. Butler, P. A. , 1969. The significance of DDT residues in
estuarine fauna. In: M.W. Heller and G.G. Berg
(Eds.), Chemical Fallout.' C.C. Thomas,
Springfield, Illinois, 531 p.
• • -- • ' . *
33. Burdick, G.E., E.J. Harris, H. J. Dean, T.M. Walker, J.
Skea, and D..Colby, 1964. The accumulation of CDT
' . *
in lake trout and the effect on reproduction.
Trans. Amer. Fish. Soc., 93: 127.
3<». McKee, J.E. and A.W. Wolf, 1963. Water Quality
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Board, Pub. A-3.
-------
54
35. Stickler, L.F., 1968. drganochlorine pesticides in the
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. • • '
37. Simpson, C.F., N. P. Thompson and J. T. Neilson, 1972.
Effect of long-term feeding of DDT to turkeys.
Bulletin of Environmental Contamination and
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38. Tucker, R.K. and D.G. Crabtree, 1970. Handbook of
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-------
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44. Kashyap, S.K. and S.K. Gupta, 1971. Indian Jour. Med.
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' • \
45. Hart, M.M. , S. Fabro, and R. -H. Adamson, 1971.
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-------
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-------
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52. Tarjan, R. and T. Kemeny, 1969. Multigeneration studies
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55. Gaskin, D.E., G.J.D. Smith, P.W. Arnold, M.V. Louisy, R.
FranJc, M. Holdrinet, and J.W. McWade, 1974.
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-------
58
56. Peterle, T.J. , 1969. Translation of pesticide-1; in the
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••''"..' • /
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-------
59
60. Kallman, B.J. and A.K. Andrews, 1963. Reductive
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- V
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-------
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•I ' •
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-------
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Salmon (Oncorhynchus kisutch) from the Great Lakas.
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»
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-------
62
79. Johnson, H.E., and C. Pecor, 1969. Coho salmon
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Jr., and G.H, Cook, 1973. Dieldrin: Effects on
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-------
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86. Cope, O.B., 1965. The effect of pesticides en fish and
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87. Earnest, R., 1970.. Effects of pesticides on aquatic
animals in the estuarine and marine environment.
Unpublished data "In: Annual Progress Report, Bureau
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Interior. . ..'••-
88, Katz, M, 1961. Acute toxicity of some organic
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threespine stickleback. Trans. Amer. Fish. Soc.,
90(3):264-268.
89. Heath, R.G., J.W. Spann, and J.F. Kreitzer, 1969.
Marked DDE impairment of mallard reproduction in
controlled studies. Nature, 224;47.
90. Shabad, L.M., T.S. kolesnichenko, T.V. Nikor.ova, 1973.
Transplacental and combined long-term effect of DDT
-------
in five generations of A-strain mice. Int. Jour.
Cancer. 11:688.
91. Tdnatis,'L., V. Turusov, R.T. (Charles, and M. Eoicchi, 1974.
Effect of long-term exposure to l,l-Dichloro-2,2-bis
(p-chlorophenyl) ethylene, to l,l-Dichlorc—2,2-bis
(p-chlorophenyl) ethane, and to the two chemicals
combined on CF-1 mice, Jour. National Cancer Institute, 52(3):883-891.
92. Turusov, V.S., N.E. Day, L. Tomatis, E. Gati, and R.T. Charles,
1973. Tumors in CF-1 mice exposed for six consecutive
generations to DDT, Jour. National Cancer Institute, 51(3):983-997.
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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: Kishes that spend a part of their lives in seas
or lakes, hut a.s
-------
EC50: The concentration at which a specified effect is observed
under the test conditions in a specified time in fifty permit of
tin.' organisms tested. Examples of specified effects an1 hemor-
rhaging, decreased feeding, dilation of pupils, and altered
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. ' . " '
[•'low-through bioassay; An assay system in which aquatic species
are exposed to toxicants in a constantly flowing system, and where
the-toxicant is replenished continuously or diHcontinuously.
Hardness (Water): The concentration of the polyvalent metallic ions
dissolved in water. Unually it is reported as the equivalent
concentration of calcium, carhpnate (CaCO ).
.3
Hyperplasia: 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.
-------
LC25: The concentration of a toxicant that is lethal (fatal) to twonty-
five percent of the organisms tested under the test conditions in
;i
a specified time.
L(.T>0: The concentration of a toxicant which is lethal (fatal* tt>
fifty percent of the organisms tested under Urn: test conditions
in a specified lirr.t?. |» is virtually identical with TLm ami TL.r>6.
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 medium rather than the
amount ingested by or administered to the organism.
Liter (I): The volume occupied by one kilogram of water at a pressure
'o
of 760 mm of mercury and a temperaturr of 4 C. 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).
-------
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 'if
one kilogram. A gram contains 1000 milligrams.
Milligram per liter (mg/1): The concentration at which one milligram
is contained in a volume of one liter. Where the density of the
solvent 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/1): 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.
-------
Parts per thousand (o/oo): A concentration at which ow 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 bic^issa-" 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 I', or greater per meter of depth.
TLm - Median Tolerance Limit: The concentration of a test material
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.
TL50: Synonymous with TLm and virtually synonymous with LC50.
Tumorigenic: Causing or producing tumors.
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APPENDIX A
-------
JI. F. & R» Dockets Hos. 63, etc.]
CONSOLIDATED SDT HEARINGS
©pinien and Order of Jh®
Published herewith is my opinion and
ordeir Jssued June 14, 1972, concerning
the registrations of products containing
the Insecticide DDT.
Done this 30th day of June 1972.
WE&XASS D. ROCKELSHAUS,
Administrator.
STEVSSJS JWBWZBZZS. INC.. ss A&.
OPZmON O? THE ADMINISTRATOR
Before $ae Environmental Protection
Agency: In re: Stevens Industries. Inc., st
aL (Consolidated DDT Hearings) , IF. & B.
Docket No. 63 et al.
This bearing represents the culmination
of approximately 3 years of Intensive ad-
ministrative inquiry into the uses of DOT.
Fart £ sate forth the background of these
proceedings and Fart II contains a discus-
sion of the evidence and law and my factual
conclusions. 1 tun persuaded for reasons set
forth in Fart ni of this opinion that the
long-ra&ge. risks of continued use of DDT
for use on cotton &nd most other crops is
•unacceptable and outweighs any benefits.
Cancellation for all uses of DDT for crop
production and nonhealth purposes is here-
by reaffirmed and will become effective De-
cember 31, 1972, in accordance with Fart V
of this opinion and the accompanying or-
der, except that certain uses, for green pep-
pers. onions, end sweet potatoes in storage
may continue on terms and conditions set
forth in Part V of this opinion and the ac-
companying order.
I— A. Background. DDT is the familiar
abbreviation for the chemical ( 1,1,1 .trlchlo-
rophenyl ethane) , which was for many years
the most widely used chemical pesticide in
this country. DOT'S Insecticldal propertied
were originally discovered, apparently by ac-
cident, in 8939, and during World War n it
1D-5S. DDT has been used for general
caatrcS of oioaqultoas. boll weovii laf variety
02 ofch«e uaaa. Peak use of DDT occurred a>6
£&o oad of the lOoO'a aud present domes! 16
wcc og DDT in varlouo formulations aas
baon estimated at 0,000 tons por year.1 Ac-
cording to Admission 7 of the record, ap-
proximately 06 percent or 10.277.238 pounds
of domestically uocd DDT Is applied to cot-
ton, crops. The same admission Indicates
that 603.063 pounds and 037.001 pounds, or
approximately 6 percent and 0 percent of
the total formulated by 27 of tho poUUonrrs
8n thesa hearings are used respectively on
soybean and peanut crops. All other uses of
the 11,966,186 pounds amount to 158,833 of
taa total, or little over 1 percent.1
Counsel for the Agency has called to our
attention publication of the Department of
Agriculture, The Pesticide Review of 1071,
wfcica estimates "a domestic disappearance"
rate Of 25.4S7.000 pounds for DDT io. 1970.
3ae p. 28. The motion to Incorporate) this
publication is granted, as is the motion by
registrants to supplement the record, see
infra. I do not believe, however, that ibo
Pesticlda Beview figure can be accepted, on
its face, without further explanation. Stone
the rc--Jt Z rcf ih today would, U anything.
only bo reinforced by the higher figure. I
see BO need to remand.
For tSia above ..sea it appears that DDT la
sold in four different formulations: Emulsi-
Sable sprays; dust; wettable powder; and
granular form.
Public concern over the widespread uss> of
pesticides was stirred by Bachel Carson's
boots, "Silent Spring." and e, natural out-
. growth was the investigation of this popular
and •widely sprayed chemical. DDT, which
for maay years had been u&ed with apparent
safety, was. the critics alleged, a highly
dangerous substance which killed beneficial
iasects. upset the natural ecological balance,
ana collected, la the food chain, thus posing
a hazard to man, and other forms of ad-
vanced aquatic and avlan life. In 1969, the
U.S. Department of Agriculture commenced
a review of the health and environmental
hazards attendant to the use of DDT.
Certain uses of DDT were canceled by the
Department of Agriculture la 1969 sad In-
formal review of remaining uses continued
through 1670.° In early 187X. thla Agancy
commenced formal administrative review ot
DDT registrations by the cancellation, of all
registrations for DDT products and uses
pursuant .to section 4(c) of the Federal In-
secticide, Fungicide, and Bodenticlde Act
(FIFRA) 7 U.S.C. section 135 (1972).°
1 Admission 9 shows that domestic ship-
ments of DDT by its sole manufacturer,
Montrose Chemical Co., totaled 8.327,900
pounds between January 1 end August 1,
1971. Total domestic sales in 1970 were
11,963.196, as stipulated ia Admission No. 7.
The Examines- found, apparently .based on
Admission 7, that domestic use in 1970 "was
just under 12 million pounds." Exam, Roport
at 92.
0 Some discrepancy in the figures exists
since the figures given in breakdown of use
categories total 11.977,065 pounds, slightly
more than the total sold by the 27 formula-
tors who supplied figures.
°PR Notice 69-17. Among the canceled
uses were applications to treeo for control
of Dutch Elm disease, tobacco, home uses,
and aquatic uses. 34 F.R. 18827 (1969).
°Xn Environmental Defense Fund v. Buc-
kelshaus, 439 P. 2d 584 (D.C. Clr. 1971), the
court of appeals held that cancellation pro-
ceedings should be commenced whenever s
registration of a pesticide raises a "sub-
stantial question of safety" which warro&ts
further study: On Jan. IS, 1971, all uses of
annl suijo of ronnai adnuaistmtivo re-
.° TJvlr;j-6rau rw^&tr&nts hive eh&llenjred
15 o£ "Jia canceled use* of DDT nr.ti Its n»c-
tAbollu>. TDS.° taesa vsaoa of DOT ir.clud-;
applie&tiors to cotton &cKs to eont^i the
bcdl 7««v1i cad fcollwnB appllcaticna 10
rortov.3 vegetable crops, and D variety of
leoser wwa to public programs. Tho caaa tor
caacsll^tion has been presented by cc'.ir.sel
• for the Pesticides Office of tho Environ-
ments! Protection Agency ami attorneys for
the EuvUxT.mental Defense Fund which it
an Ir.tcrvunor. Other parties inclv.do SH
Lilly & Co.. whtcli hclJ o DDT r«!istTOt;c.-.
for "topoclde," a prescription dr\'.s." n. P.
Cannon ft Son. a user of DDT." and repre-
sentatives of. the chemical manufacturing
industry and various wildlife groups."
The testimony and exhibits cover in ex-
haustive fr.shlon all aspects or DDT's c'.'.emi-
cal ah reg-
istrant la allowed to continue shipment of ils
product.
0 UrJesf speciflei, discussion of DDT la this
opinion applies to TUB. DDT has three rrjijor
breaidowa products, PDA, HT22, anil DI2D-.
separate ?esl8t?sa«no czbt ios TU2 - (DDE).
» There has bsea aoaaa controveroj' ove? Eli
Lilly's etatus because it failed to appeal can-
cellation. o2 its registration trtt-nln SO aavs
03 requirsd by scctloa 4(e) of FS3^f-. For tho
purposes of this ease X beliovo they should
ba s«corded status oo parties.
° There him beoa somo question as to
•whether or not a "user" has staadlas to
appeal a caaceU&tion end %huo seek rein-
statement of D caacsleel us® area though so
regiatsaa? bos stepped fOFv7&?6 to oppeel. Ttio
some refcscniag employed by the court l£
Environmental Defense Fund 7. SucJieic-bn^,
supra, end Environmental Defense Fund v.
Hardln, -528 P. gd 1093 (B>.C. CSr. 1070). -sbscl;
accords standing %o "public interest" groups
gives "vissrs" o slgfe.6 to appsei c> caacella°
ttoa.
"The groups are: National Agricuitur&J
Caomlcals Association; National Autiucc:-.
Society; The Sierra Club; Rn«4 West fctlchijan
Env Ifoamental Action Council. As already
noted, t?ae SeCKStary of Agriculture, la addi-
tion to being a party-registrant by virtue cf
regiatratlons held by its Plaafe Begulatloa
Division, has appeared ea aa intervenor.
^'EiiG following usss are involved: For coto
ton; for military use on clothing: for pep^eru
and pimentos; for fresh market com; for pea-
aute; for cabbage, cauliSowci?, and brussel
sprouts; for tomatoos; fop lettuce; for pota-
toes; fo? sweet potatoas ia storage (Southern
St&tes only); for use in commercial grcer.-
houseo and nursorles; for beans (dry, Uma,
eanp); for bet and rodent control; for err.cr-
gouoy use for agriculture, health og quaran-
tine purposes; and for onions and garlic; ar.d
for lice control. There has bcea eonsleSerab'.e
controversy as to what uses v.-ere st Issue
during the hearing. Admission No. 2 Ee'.s
forth those uses which the DcpartrHest of
Agriculture considers essential. Men- of thc;e
uses have been canceled and no Appeal tcru
t&lcca. The uses &6 issue la this hcarlr.; t:9
only these notid ia Admission 11.
'_ 37,
, JUtY 7,
-------
"Pesticide's Office and Environmental
Fund (EDP), In prcssntlng their
against continued registration for DDT,
less aiosfc heavily oo evidence which, they
contend, eotabllcues: (1) That DDT and its
metabolites MO toslconte which persist in
pt>U end tho oquosphere; (2) that once un-
leased, DOT to an uncontrollable chemical
which eoa bs transported by teaching, ero-
oioo. runoff, nnd volatilization: |3) that, DDT
is not wnter soluble and collects In,fa6 tissue;
(4) that organisms tend Co collect and con-
centrate DDT: (B) thut tlieaq qualities result
In accumulations of DOT lu, wildlife and
humans: that once otored o? ooiioumsd. DOT
can bo toxic to both animals and humans,
and In the case of ash and wildlife Inhibit
regeneration of species: and (7) that the
benefits accruing from DDT usage are mar-
ginal, given the availability of alternative in-
escticides and pest management programs,
and also the fact that crops produced with
DDT are in ample supply. The testimony and
exhibits include numerous reports of expert
scientists who have described observed effects
o? DDT la the environment and the labors
lory.
Oroup Petitioners and the UJ3. Department
of Agriculture (TJSDA) seek to discredit the
Agency's case by citing the record of safety
DDT hes compiled throughout the years, and
polssS to the negative findings of epldemio°
logical and human feeding studies carried
oufe over the years on Industrial workers and
volunteers exposed to concentrated levels of
DDT is? In excess of that to which the aver-
age Individual Is exposed. Proponents of con-
tinued registration have also introduced
osperfe testimony to the effect thq,t DOT'S
chronic toxlclty to man or animals has not
bean established by adequate) proof. The
registrants have attacked the assumption
that laboratory data, as to affects of, exag=
gerate& doses of DDT, can provide B Bxean°
ingful basis for extrapolating effects on man
or the environment. In the alternative,
Oroup Petitioners contend that whatever
barm to the environment might be attributed
4o DOT. it results from misuse and 6ver°
losing that occurred in years past. Lastly,
Oroup Petitioners and USDA have attempted
4® prove that DDT is effective end that ito
•use is moro desirable then the organophos°
phatas which are more acutely tozio and
costly than DDT.
On April 25, the Hearing Examiner Issued
an opinion with proposed findings, conclu°
etona and orders recommending that all
"•essential" uses of DDT be retained and thafc
cancellation be lifted." The Examiner's re=
port which has findings, conclusions, and an
opinion, is attached below. The Examine?
apparently accepted in his report the
Agency's proof that DDT is a hazard to
aquatic and terrestrial wildlife and substi-
tutes exist. He found, as R "matter of fact,"
DDT can have adverse effects on beneficial
animals; that 16 Is transferred through tho
food chain; that DDT is fat soluble. Ho
concluded, however, &a D, "matter of law,"
that DDT IB neither & carcinogen nor terato°
gen. that the particular uses at Issue do not
adversely affect wildlife, that DDT uao has
rapidly declined. (Examiner's Rept. p. 93.)
Tho Pesticides OSlco of this Agency and
intervonor Environmental Defense Fund
(ED?) Sled exceptions to the Examiner's
report," challenging his application of Che
burden .of proof to this caso. hla findings of
fact, conclusions of law, and numerous evi-
dentiary rulings. Exception was also taken
to tho Examiner's application of t'uo so-
called "risk and benefit" atnndnnt of I'lFKA.
On M.iy 3, 1072, the Judicial Officer pro-
pounded by order, at my direction, a series
of questions for briefing and discussion afe
oral argument, and oral argument was held
on May 16. That argument was transcribed
and is part of this record. Oroup Petitioners,
USDA, EU Lilly, and H. P. Cannon ft Sons
have also responded to f&@ briefs on
exceptions.' ' :
II.—A. Applicable law. The basic FD7RA
schema has beon', outlined in court opinions
and Agency decisions (see EDF 7. EPA, D.O.
Clr. Slip. Op. 71-1365. P. 2d ,
May 5, 1972 (opinion of Judge I/eventual);
Stearns Hoe. Paste Co. v. SPA,. 7th Clr. Slip
Op. No. 71-1112. „„;„ P. 3d -«, , May 11,
1072: Continental Chemists Co. 7. EPA, Ttfl
Clr. Slip Op. No. 71-1828, ... P. 2d —=„,
May 11, 1S72; EDP 7. Ruckeleaaus (opinion
of Judge Bazelon), eupra; Statement 'of Rea-
sons Concerning the Registration of Products
Containing DDT. 2.4,a-T, and ' Aldrin/
Dloldrln. March 18, .1972; Xa re Hart-Karl
Undone Pellets, et aJU £F.&R. No. 6 (1071)).
Willie there la no need to trace In detail once
again the statutory scheme, & brief sum-
mary provides a useful prism fo? altering the
evidence.
1. FIFBA. The Federal Insecticide, Pungl-
clde, and Rodentlclde Act, 7 T7.S.C. section
135 (1973), establishes s strict standard foe
tho registration of pesticides. Any "economic
poison" which, cannot be used without ln°
jury to "men or other vertebrate animals,
vegetation, and useful Invertebrate .animals"
Is "mlsbranded," l° and la tharofara subject
to cancellation.14
"Exceptions have also been received In
Docfcofe 106, Xn Be Wallarsteln, Stork Bros.
Nurseries held a registration for use of DDT
on nursery plants. The Examine? secora=
mended cancellation on the grounds that
this was not on "essential" use according to
TJSDA. . ' .
"Sees. §(ai) (2) (c). (d), onfi (g), respec-
tively provide:
"The term 'misbranded' shall apply—
(s) To eny economic poison-^
a o o o 'o
(o) If the labeling accompanying it does
not contain directions for use which aso nec-
essary and tf compiled with adequate tog the
protection of the public;
(d) If the label does not contain a, warn-
ing or caution statement which may bo nec-
essary and .if compiled with adequate to
prevent Injury to living man and other
vertebrate animals, vegetation, and useful
invertebrate
"There is some confusion as to what tho
term "essential" means. By Admission No. 2
the parties stipulated that certain uses were
"essential" in tho view of USDA. No atlpula=
tlou eslsts that these uses are, in fact, essen-
tial in that no alternatives exist or that a
shortage of a crop would result without DDT.
(g) If in the case of an Insecticide, >iema-
•toc'.de. fungicide, or herbicide when used as
directed or in accordance with commonly
recognized practice it shall be Injurious to
living man or other vertebral animpla, or
vegetation, except wesds, to which it is ap-
plied. os to tho person applying such eco=>
aomle poison;
o o o o o
» Sec. 4 permits tho Administrator to can-
cel a registration "if it appears that 'the
article and Its labeling ° ° <" do not comply
with [tho Act)." Since the Act prohibits dis-
tribution of e> "misbrandcd" pesticide, sec. 3
(a) (5), the registration for a, "mlsbronded"
produce may be canceled.
•While the language of tho statute, taken
litnrtl/y. requires only a andlng of Injury to
noiitaigat sptcles, the Inquiry cannot, how-
ever, end with & simplistic application of this
pihiu statutory language. Both judicial iuiU
aU-jilnlstratlva procedairt recosulzc thivt Con-
gress Intended the application of a balancing
t*ot, tliat would measure the risks of wins ^
pv^lonlar chemlcivl agiUtist Its bencllts.10 If :v
prc«l\K:t Is "nilsbrnnded" wttliln the meixnlus
of the Act. !.«., If it Ixmra ^ tn.bcl ror use that
do*s not moot the orllortu, of section 3. it mtxy
no longpr be shipped In Interstate coinim-n-e
ftivl stocks In bund In tho criglnul pftc'icngc
may bvj seined. 7 U.S.C. section 135(g) (10T2).
!'.. Risks aiut benefits. It follows from the
ctatutury scheme and this Agency's decisions
that evidence of oacK alleged risk must be
reviewed and B conclusion reached as to
whether or not, and in, what degree, such risk
is incident to the directed use of a particular
product. The task, however. Is complicated la
tho cess of .a "persistent" pesticide by Its
possible chronic effects. The degree of persist-
ence, extent of overall usage and mobility all
bear on the amplitude or Indeed the exist-
ence of tho rlob curve.14 I believe, however. It
is useful to Isolate the alleged risks and eval-
uate each on the assumption that they are
unaffected by overall levels of use, and defer
to Por5 17 the discussion of the elgnlfl.car.ee
of tho relationship between risic and overall
uso. .
ni.—A. .Analyst? of evidence.—1. Risks—a.
Health, effects and. environmental properties.
Tiers is no dispute on this record that DOT
is & nonspecl&c chemical that kills both
target and nontarget species in the immedi-
ate ares, of application. Few chemicals, how-
ever, aro so selective that they can be used
without causing some Injury to "nontarjet"
species. Wo muct therefore proceed to the
evidence bearing on other "risks" and th9
"benefits" from using DDT.
X am convinced by a preponderance of the
evidence that, once dispersed, DDT is an un-
controUable. durable chemical that persists
in the tvqu&tlc ead terrestrial environments.
CHvois its insolubility in water and its pro-
pbuslty to be stored in tissues, it collects in
the food chain and is passed up to higher
forms of aquatic and terrestrial" Ufa. There
is ample evidence to show that under cer-
tain conditions DDT or its metabolites cnn
persist In soil for many years,1' that it will
volatilize or move along with eroding soil.11
While the degree of transportability is un-
known, evidence of record shows that it is
zs Sea EDF v. EPA (opinion of Judge Leven-
tlial), supra; EDP 7. Ruclcelshaus (cplnlon.
of Judga Bazalon). supra, DDT Statement of
Reckons, supra; sea also Statement of Rea-
sons Underlying Suspension and Cancellation
of Products Containing Mercury, 37 P.R. 0413
(Map. «9, 1973).
i" other factors bearing on risk may In-
clude nho geographical location of applica-
tion, see. e.g.. Statement of Reason,-! Underly-
ing Registrations foe Strj-chnlne, 10SO. atitl
Sooium cyanide. 37 SMI. 5718 (1072).
&lUioutfh thle may not b® (is significant whcro
the chrmlc&l Is highly volatile 00 la tho co-x>
with DDT. See also Statement of RCMORS
Underlying the Cancellation of Mlrcx, Deter-
mination and Order of tho Administrator at
7 (37 F.R. 10087, June 1. 1072).
"Method of application and typo of eo'.l
and clLnate can affect persistence In soil and
likewise runoE Into aquatic areas.
^ Registrants have made much of tho fact
that aquatic contamination and the spread
of DDT have resulted from drift during aerial
application. While tho Examiner's report
dwells ut somo length on Improved methods
of application, 1C roccgnlzes runoJT as n signif-
icant source of aquatic contixmlnntlon, even
with Improved aerial spraying techniques.
-------
7.3
occasionally found la remote Mono os in,
strofuk opocloe. such as whales, fa? from c,ay
Known nrea of application,
PotsUtonos and blomagnlflc&tion ia tho
food chain tuo, of themselves, e> cause for
concern, given the unknown and possibly
forever undeterminable long-range effects o£
DDT in man, and the environment.^ Lab-
oratory tests have, however, produced tumort-
genlc efiecta on mice when DDT wao fed
to them at high levels.*9 Most of the c&ncc?
resQarch eirpsrts who testified at this hear°
ing indicated that it was their opinion that
the tumorigenic results of tests thus fas
conducted are on indicator of carcinogenity
and that DDT should be considered a poten-
tial carcinogen.11
Croup Petitioners argue that the testi-
mony is in conflict and fasten on to the tes°
tlmony. of the Surgeon General that ot Drs.
Loomls and Butler. The Surgeon General's
statement was, however, cautious and, by
no means, carries the burden that the Oroup
Petitioners seek to place on It. In very gen°
.erei terms the Surgeon General stated: "We
J&avo no information on which to indict DDT
either ac a tumorlgen or ns a carcinogen foe
man and on the basis now available, £ can-
not conclude DDT represents an imminent
health hazard." (Tr. 1350.) This testimony,
hovraver, does not bear on the long-term
offocto of DDT, nor did tho Surgeon General
oapreas & view on what uses, apart from
health uses, would justify continued use o£
DDT. Indeed, tlis entire thrust of the Sur-
geon General's testimony was only that usa
for immediate health needs outweighs the
possible long-range effects of DDT on human
health. Group Petitioners' other witnesses,
Drs. Loomis and Butler, while men of stature
In their fields—toxicology and pathology—
and knowledgeable about cancer treatment
and diagnosis, are not specialists In cancer
research as is Dr. Samottl. Indeed, Dr. Butler
disclaimed such expertise.
Group Petitioners also take refuge under R
broad canopy of data—human feeding
studies and epldemiologlcal studies—=and
10 It Is particularly difficult to anticipate
the long-range effects of exposure to.a low
dose of a chemical. It may ta!:e many years
beforo adverse effects would tafee placs.
Diseases like cancer have an extended latency
period. Mutagenlc effects will be apparent
only in future generations. Lastly, it may be
Impossible to relate observed pathology In
man to a particular chemical because of tho
inability to Isolate control groups which EJO
not exposed in tho same degree as tho sost
of the population.
"Tumongenic effects have been noted la
a number of laboratory experiments. The
moat positive results were developed by the
Blonetlcs Study and the Lyons and ft*M<»a
tests. The Blonetlcs Study of the National
Cancer Institute fed 120 compounds to two
strains of mice. DDT was one of IX com-
pounds to produce an elevated Incidence of
tumors. The Lyons and Milan Studies of tho
International Agency for Research of the
World Health Organization is a multlgener-
atlonal study (still In progress) of 6,000 mice
of in- and out-bred strains. Increased hepa-
tomas were noted in male and female mico
fed DDT at 250 p.pjn. Matastasls to the
lungs or kidneys has been recorded in. Eve
instances.
3 Witnesses testifying to the positive cor-
relation between tumorigens and carcinogens
wero Dr. Umberto. SafflottS, Associate Scien-
tific Director for Carcinogenesls, Etiology
Area, National Cancer Institute; Dr. Marvin
Schnelderman, Associate Chief, Biometry
Branch and Associated Director for Demog-
raphy, National Cancer Institute; Dr. Samuel
Epstein, Senior Research Associate is Pathol-
ogy, Children's Cancer Bese&rcb Foundation,.
Inc.. Boston.
oapporfe tt •wltfe fcke Jaoretvalngly fnmilla?
asTfumaat ttjofc eapeauro to any 6\it3t*aqe la
(juffldoafe qusafcUlou saay cause cancor.
Noao of tko feeding studios carried out
with DDT have been designed adequately to
detect carolnogenidty, and glvaa the le-Uncy
period of cancer, theee studies would have
to bo carried out So? a much longer peii&a,
Statistical population samples los epidfini-
ologicai studies are also virtually Impossible
given the latency period for cancer end the
long-term exposure o« tho general popula-
tion. Since there la no sharp distinction bo-
twean population groups exposed to low
Uoses end hlghe? doses of DDT, adequate
control groups cannot be established. The
"everything la cancerous argument" falls bs=
cause 16 ignores tho tact that not all chemi-
cals fed to animals in equally concentrated.
doses have produced the name fcumorigenio
results. -
b. Environmental effects. The ease against
DDT involves more, however, than o, long
range hazard to. man's health. The
present i by t>*3 Agency's Pesticides
and the intervenors. 2DF, compellingly
onstrates tho ed.veraa Impact of DDT ::& flab.
and birdllfe. 6e\ .Al witnesses testified to
first-hand observed eSects of DDT on ash
and birdllfe, reporting lethal of sub-aeuta
effects on aquatic and avlan life exposed to
DDT-treatad areaa. Laboratory ovlden.ee is
also impressively abundant to show the scute
and chronic ejects of DDT oa avion animal
species and suggest that DDT impairs their
reproductive capabilities.23
The petitioner-registrant!)' assertloa that
there is no evidence of dacllnlng aquatic of
avlan populations, even if actually "Sius,. la
an attempt at confession and avoidance. -It
does not refute the basic preposition, that
DDT causes damage to wildlife species. Group
petitioners' argument that DDT' is only one
toxic substance in a polluted envlroiwaeat.
and thus, whatsve? Its laboratory effects, it
cannot be shown to be the causative &gen«
of damage in, nature, does not redeem DDT,
but only underscores the magnitude of «ffort
that will be necessary for cleaning up the
environment. Were we forced to isolate in
nature, rather than in the laboratory, the
effects o£ various toxic substances, it vould
be difficult if not impossible to make a ,iudg=
' meat as to the chronic effects of any chemi-
cal. As ou? DDT statement of March 1071
has noted: "Development of adequate test-
lag protocols and facilities is a priority un-
dertaking. But in the short term, extrapola-
tion. from amaU-scale laboratory annlyees
must err on tho side of safety." See DDT
Statement of Reasons, at 11. . •
Anally, X am persuaded that & prepoader-
ance o£ the evidence shows that DDE causes
thinning of eggshells in. certain bird species.
The evidence- presented Included both lab-
oratory data, and observational data. Thus,
results of feeding experiments were lntro=
duced to show that birds in the laboratory,
when fed DDT, produced abnormally thin
eggshells. Is, addition, researchers have also
correlated thinning of shells by comparing
the thickness of eggs found in nature with
that of eggs taken from museums. The tausc-
um eggs show little thinning, whereas eggs
takon from the wild after DDT use had be-
come extensive reveal reduced thlctaew.
Group Petitioners and "CTSDA trcue that
tho tsboiatory toadies studies, conducted
with axaggarawd dues of DDS and under
stress conditions, provida no basis for or-
•teapolating to naturo. They suggest tint the
study results axo contradictory and plnco
particular emphasis on documents which
wore not part of the original record and
tho inconsistencies in. Dr. Heath's testimony
oa brought out duvlng cross-examination.
Group Petitioners also contend that ths ob-
served phenomenon of eggshell thinniri? and
DDE residue data arc tied by a statistical
thread too slender to connect the two in
any meaningful way.
Viiwlng the evidence as a total picture, 2,
preponderance supports the conclusion this
DDE does cause eggshell thinning. Whether
os not the laboratory data above would sus-
tain this conclusion is besido the point. ?or
hero there la laboratory data and observe
tlonal data, and in addition, a selentlSc
hypothesis, which might explain the phe-
nomenon.01
B. Bsnefita=~ 1. Cotton. X era conTlnced by
the evidence that continued use of DDT is
aot necasaary to insure an adequate supply
of cotton at e, reasonable coot. Only 33 per-
cent of cotton-producing acreage is treated
with. DDT, although the approslmately
10,2T7,2E3 pounds uced tn cotton production
is a substantial volume of DDT and accounts
for most of its use. The record contains
testimony by witnesses called by rejistrante
Bad TJSDA attesting to the eQcacy ct or-
gtmophosphate chemicals as substitutes fo?
DDT and, long-range, the viability of pest
management methods, such us the dtepause
program. At present moat areas that: use
DDT combine It with an orgnccpbos?hata
and toxaphene in a'4-S-i mixture (4 ibs.
toxapheac. 3 DDT, i methyl parathion).
Some areas, however, according to the testi-
mony, which normally use DDT occasionally
apply concentrated methyl parathion in a
-------
also testimony In the record to the effect that
methyl prunthlon costs less per application
than the DDT-toxapueno formula. Nor aw
the testimony and exhibits that show cotton
In&acU rtevolop resistance to organophoa-
phftte chemicals to tho point. Th« very earn*
MhlblU moke clear that DDT 1* also subject
to resistance.1*
Group Petitioners and tISDA, while not
dlapuUiiK Uio lejser puwlstonco ot orgnuo-
phoaphntut, huv» strewed tholr demortatratBd
ncutB wxtcity. While they we toxlo to boiio-
nclnl noil ituieei.i mid non-target speciaa. por-
tlr:ul(iriy birct.i alighting Ion treated fields.
theno orgimophor.phatcB break down more
readily than DDT. They apparently arc not
transported In their toxlo stato to remote
areas, unlike DDT which has been found
far from treated areas, and consequently
do not posa the same magnitude of risk
to the aquasphere. Both testimony and ex-
hibits also demonstrate that organophos-
phates are less acutely toxic to aquatic life,
although different compounds hare different
toxlcltles. The effect of organophosphates
on non-target terrestrial life cau. unlike the
effects of DDT. also be minimized by prudent
use. Application in known nesting areas for
rare or extinct birds can be avoided.
2. Other crop and produce uses. The testi-
mony of record, while sparse, shows thnt
registered alternatives, primarily organo-
phosphates. exist for all other crop and
ornamental uses of DDT. except for storage
use on sweet potatoes to control weevils, on
heavy corn borer infestations of green pep-
pers, and perhaps onions."
3. Woncrop uses. In addition to the regis-
trations for use oil crops and in nurseries,
several registrations for noncrop uses are olao
In isaue. Admlsalon 11 lists "public n»aith
pesta—bats fend rodents," "AgrlcultunU,
•»—Continued.
iiubstdy is the difference between profit and
brcixk-oven. It la not clear whether or not
break-even includes a return to the farm
owner In terms of salary or return on his
investment. While some evidence suggests
that organophosphates are more costly, be-
cause of higher price and the need for re-
peated applications in concentrated quanti-
ties, there Is little to suggest that the> pos-
Rlblo increased variable cost from use of
organophosphates would be a disincentive
to producers. Indeed, with subsidies it Is not
clear what rote of return a cotton producer
receives for invested capital. There was a
reference made to an unidentified study
showing that the cost of using substitutes
would involve SIS million. This figure alone
baa no meaning. While later testimony sug-
gests that elimination of DDT would in-
crease variable costs per acre by 6 percent,
thla, too. Is of limited significance since the
record does not relate it to the support pro-
gram and the study looked at only a limited
area.
»I cannot accept the suggestion that we
should continue to use DDT until it is good
to the very last drop. Whatever the long-
term eQcacy of the organophosphates the
fact remains that they generally work. While
the fact of Insect resistance is Important
and underscores the need for retaining a
variety of chemicals or methods to manage
tho same pest problem, thla fact does not
Justify an avoidable us* ot •> harmful
chemical.
"Toisphene and dlAzlnon are registered
for control of cutworms but it is not clear
from the record- as to whether or not these
chemicals are registered ot effective to con-
trol cutworm infestations on onions. While
none of the parties have pointed to helpful
evidence In connection with use for con-
trolling cutworms on onions and weevils on
stored sweet potatoes, I hsvo token judicial
notlo* of the nonexlstenco of registered
alternatives.
NOTICES
Health, and Quarantine Treatments ta
Emergencies as Recommended by anil Under
Direction of Gt«,t«-FedertU Offlcla!i" ' im/i
•f abria treatment" by tho mUtt&ry.
The. record is not, unfortunately, TCll de-
veloped, aa to the scope or motuod of ivpplloa-
tlon for these uses nor a* to the ovaraU
volume applied for these purpoiea. Wtitle use
for bat and mica control U oharnctadaKl ti
ACmbwlon 11 tls a "public health u;;*." ta-
pllcctlon tor thedo purpotstvt i» not eu|K>rviMd
by public health' otticiau. Tlio brlcTj augtfait
that UM for control of bnu nnd nj;ce la »
proprietary use by tho military, even t'aongh a
privat* pcit control operator testm-xl that
use for bats was considered essential by pri-
vate operators." With respect to "Agricultural
and Quarantine" uses it is difficult to deter-
mine to what extent applications ate for
health purposes or for nuisance prevention.
With respect to all of these uses, both for
public health programs and proprietary use,
alternatives do exist. The Public Health Serv-
ice testified that DDT la no longer th* chemi-
cal of choice for controlling disease vectors.
As for mice, warfarin Is used effectively, and
fumigation, and nonchemlcal means are avail-
able for use on bats. Colonel Fowler testified
that the military has not used DDT in this
country for 3 years for mothproofing pur-
poses and stated that he was aware- of
alternatives.
C. Weight to • be accorded the examiner's
opinion. In reaching the factual conclusions
set forth In the preceding sections, I have
been mindful of Group Petitioners' argu-
ment, stressed in their briefs and at oral
argument, that tha Hearing Examlaet's ftnd-
uiga deserve particular deference is view of
his opportunity to rctolva eoiitracUcUoafl lu
testimony baaad on dsatsnnor evidence.
Nowhere does the Jteaminer stato that bin
conclusions wtre based on credibility
choices,31 Whatever extra weight, thsa, that
might b* due findings based expressly on a
credibility judgment la not appropriate In
the csso before m«. Sao, e.g., I7LRB v. Dinion.
CoO Co., 201.7. 2d 484 (2d Clr. 1BS2) where
the Examiner's report set forth his assess-
ment of the- witnesses' credibility.'*
IV. The application of tho risk-benefit teat
to the facts of record 13, by no means, simple.
We have noted in our statement of Much 18,
1971, thtt the? variables are numerous. It
should ajeo bo- bora* in mind- that thtt varia-
bles are not static in point of tlmo. Ac build-
up of a chemical occurs or 19 detected in the
environment, risk increases. Indeed, it may
be that tho samo tendency of a chemical to
persist or build up in the food chain la
present but not known about substitute
chemicals. It may aUo be that circumspect
."The only evidence as to the amount of
DDT used, for these purposes wen given by
Col. Fowler, who said the total trscd by tho
military for bat and mousa control 10 ap-
proximately 800-800 pounds.
"During oral argument counsel admitted
that tho Examiner's report did not purport to
make findings based on credibility of wit-
nesses, nor could ha point to findings which
might bo explained In. light of a credibility
contest. (Transcript of Argument, p. 3S-G8.)
The basic questions of fact in thla case, the
hazard to man and the environment, were
cost and resolved by the Examiner «? "con-
clusions of law."
"The> precedents, moreover, ma&c clear
that the Agency la frea to make Ita owt» find-
tags and that tho Examiner's, findings.und ro-
per*; only comprise part of tha record which
a court will then evaluate. FCC v. Allt-ntowa
Broadcasting Corp.. 319 U.S. 368 (1G55); Uni-
versal Camara, Corp. v. NLK2. 340. U.3. 474
(1951). Svon where on. Examiner's findings
are based on, credibility, tho Agency may
reach a contrary conclusion. S«» FCC v.
Altentoxro Broad (rating Corp, supra.
application of a chemUxvl In limited qua-
lities for those uses moat necessary choii^'-s
tho beneflt-rlalc coefficients so iva to tilt :!•-•-
ocaleo differently tLan vfh»n we weU:h njtrrc-
(ji\t« uso for all purposes r-gutnot a^grtgace
bunsflts. S«« generally HDP v. EPA (oplv.ic:-.
of Jud^s tcvonthol). supra.
A. fiur&en of -proof. Tho crux of a e.inctlla-
tlon proceeding la the E»r«y of .tli« pri«ii:r;
whan uiwd M dlrectad or liv nrvurdiince uuh
"uoroinonly raeugunud prncUro." ytfrvnm
P^o«t>horu» I'witt Co. v. 1-iPA. «n|)riv 'j-hu.
nimbly stattd, mcAn* thnt ini« AKOIH-V ',i«i
the burden of going forward to establish
tlioco rlafts which it believes to require cou-
ctUatlon." In addition, an aOlrma'.lT* aspect
of Uie Agency's cae* should be the arai'.&til-
Ity of praferabla. substltuto aeons, of con-
trolllrig the pest* that are controlled by the
canceled chemical where- tha Agency Is rely-
ing on thla fact to establish that rl^is out-
weigh benefits.« Evidence showing tts aTall-
ablllty of a registered chemical or o-.^.*r
means- of control which this Ajencj's Pesti-
cides OCcc is prepared to recocur.cnd is =.
substitute at that point !u tLne. coupled — .-.i
the Agency's proof on risk, raaies ouc a-
Thai burden of rebuttal then falls on r*j-
istrants or users. They may cither seek to ne-
gate tha proof on Hsics either by rebuttict;
the basic scientific data or by showing tiii
a> particular use Is so limited as not to en.-
* The legislative history of FIFRA, Judicial
decisions and Agency pronouncernonu aU
state that the "burden of proof" remains oa
tto registrant to demonstrate that his pnxi-
\int or.tlsncs tia roquirecien'ca for registration
tha Act. Ess a. F»:pt- 6"3 at & (&=;--.
s., first 5»sa.. lC5a>; U. Rept. I'.IS &t 4
Cong., first cess.. 1DS3); EDF v. ^i'.-V
; ED? r. Ruoiwl.ilar.ua, supra: StiVejrx:;'.
of Itcaaons, liar. 18, 1071. There has, uiilcr-
tunntJly. been a great Coal of miaur.riar-
ttondtng concerning these statemouu. Sim-
ply stated, tho burdsn of proof referred to 37
tho IcgbdoUve Ulatory is tha, burdon of per-
suasion which requires a party to establish
tho exlatenc3 of primary facts. It should not
b» coaftued with tho burden of going for-
•wurd which is generally a rule to establish
too order for the- presentation of evidence.
The turdcn of going forward may, however.
have substantive consequences. Where a P&rty
which has the burden of going forward fall;
to satisfy that burden, the facts will be ds-
ctilod against him, even though the other
party may have been responsible- for .tie
bvrdan of persuasion.
While In most legal proceedings the pcr:r
which has the burden of going forward bears
tba burden of persuasion, this la not neccs-
6u.-ily tha cfiso. On somo Issues. Ilk* con-
tributory negDssncs in some Jurisdictions. 1:
may be that onco one party has introduced
evidence to put the issno In the ca.se-, ths
otacr party bears the burden of psrsutslon
on thr.t point. In a FIFRA csnwllatlon her.r-
ln^ the proponsnt of cancellation boars th»
bordern of goinu forward, bnt decs rot brar
ti9 bnrden of pgrsuoslon.
A Walla a mero «howln(j of a high dc£ro«
of ilsk. would ma!co out & prlrna faclo casa for
ciacellation, where tho A~oacy la relrlns oa
tiia BKlstence of an, alternative rather tha=.
s.'nplj- a showing ot ridk. it should, as here.
proeent its own witnesses.
n TLls hearing was conducted under ml*'?
wtlch have since been aciended. (Soo 37 F.R.
8-WS (Hay 11, 1072)). TJnfisr tho Agency's
formsr rules registrants proceeded arst at t!-.s
bearing. Thla order of precont-.tlon. which L:
now changed, was not prejudicial in this case.
The. Agency more than discharged lis burden
to. put on, a prlma faclo cose. r^jLitrint; had
an anapla opportunity for rebuttal. At worst
this inverted presentation unnecessarily pro-
tracted. the hearing.
-------
gondo? tae Hates from widespread use o? the
chemical'. They con also esais to .- eutvona, weevils on o-iorecl
sweet potatoes, &nfi sweet peppsrs. C&'pirients
of DDT labeled *~e those uses may convince
on terms sat forta ia ?art V-A. We defap to
Part V-8, iaiits, eoaslderatlon. of the proper
timlag of cancellation of other uses in light
of tha sliort=rU3i dangers of switchiag to the
use of .orsaaophosphafces without providing
training.80 •' •
C. ^ppJteoziow- af risk-benefit to no-nerep
uses. There rssialas the question of tbo dis-
position oa tiia regteteraa health and Gov°
ernmertt uses and' other noncrop xiaea of
DDT. It should ba empha^lzod tu&t th«ze
hearings have zsrer involved the use of DDT
by other nations in tuelr health control pto=
grams. As we said Ia our DDT statstaent ot
March 1971, "this Agency •wllJ. not presume
to regulate the felt aeoessltles of other
countries." Statemcat, afe @. Indeed, the
STFHA 6ces ast apply to exports, g@ct\oa 7,
7 U.S.O. Beetles XSfl (1973).
Gives tae aJtswaatlvea «o? aiotiprooang
and cc&troi &S bate aad, mica—proprietary
governmea£ai \Jsso ef DD11—£ am persuaded
tha.t the bsaefflte efs evea more de mJaimis
thaa the rla&s. On tho other hand, publio
health aad quaraatiae progrfoae fall into a
wholly eepsrata category. £49 SDF v.
• Huclcelshsus, 439 F. Sd s>t 68-1; DDT Stats-
meat of Ksasoao ag Xi.
Wlilte alternatives also odst fo? vss la
public health quarantine procraiaa aud, in
mo=3t laataacas. DDT Is no loader th9 y>ut
ao&supervl£Cd use fo? ticis purpoiia ty
prirs.tc citUona. I asa. aeeordinsl?! rc-T'ii^i-?
o iafcol which will restrcia ladiscrtrr.i:^'.-; use
of DOT to? a vrtio variety of purp««s xisiir
tha rubric of oicloi use. Ta»t libel li=-uaTO
Js sat fosta la da erS&r scconpaaTlr-j: th:s
cplaWEU «uad Is desisaed to restrict tiip^.on;
of DDT omly to U^J. Ooveraaaesit oSciiis and
State health dep&rtaeats wto win be
Jcnowledecabls as ta the most elective raesjia
for controi aad miaUtul of the risXa of using
DDT. Thus^ ca ea tpplicatioa-by-appllca-
tion basis for ascwsary health aad quaran-
tine purposes, Usa bsnents will to maslmlzM
and outweich the ris&a.0' Cf. «3 TT.3.C. sec-
tion 4332 (1071) which zecjuixea aa environ-
mental impact efesAomaafe on ctsclng off.ci&l
pro;raaie.
V~ X tura now te the disposition of thes«
dockets ia listt of tha foregotcs P?iasipi«s.
At toe outess it chould be noted toit iec3:i»
jmjioial decisions have urged this Agency
to UBS its -assiiiSlty, ia both Saal decisions
and KuraenoioA orders, to durereiitlace be-
twoa-a uses of ttje r?ci««*-"
-------
70>
6
unions as with peoiwts.**nono are op
red. No party JIBO citod evidence of
ohowtnjj «jhs« poscenfe o£ tfao onloa-
aereano would be tbffectad by a
coucellQtlou »i DDT.
Tho evidence with reapoct to use o« DDT
os c> "dip" to protect stored awcot potatooa
ognlnet weevil Infestation Is even spottier.
Nelthur counsel for Ibo parties nor our re-
search hiM pointed us to evidence of record
ohowlng the preclso volume ot DDT use for
tbio purpose, its likely effect oa the envi-
ronment, or tho degree ot loss that might be
ouslalnsd by producers.
While 16 would bo fas easier simply to-
cancel c* not cancel tho registrations fop
these uses. X believe that environmental
problems should be parsed with a scalpel.
not a, hacksaw. Whilo EOF and my own stag
urge cancellation, on the ground that pro-
ducers can easily shift to producing dlffer-
eaS crops, there is no evidence as to how long
such transition, might require. Moreover, 16
may bo that continued use of a limited vol-
ume ot PDT in. these few areas, taken In
conjunction with aggregate volume of use
for other purposes, like health, present no
risk to the environment. Obviously much of
the stress OB the "global" environment is
reduced by curtailing overall volume of usaga
and ^e must then estimate the Impact o£
use. both en the environment as a whole,
and tSie local surroundings. Lastly, It may
well bo relevant; to examine the impact on
overall supply of a commodity. Even taough
peppers, onions, and sweet potatoes may not
bs food "staples," It may be that the other
acreage la not suited for producing these
crops. Zn that event. It will be necsssary to
determine whether or not auppllea will sftt-
lafy demand, and whether or not a, transition.
period should be fixed to permit e> market
adjustment."
It follows that additional evidence la re-
quired to determine the answers to theea
questions. In the Interim the cancellation
orders v?lll remain In effect, subject to regis-
trants o? users petitioning to present addi-
tional evidence. In that event, & stay ot&es
trill Issue ponding the determination oa
remand. If, these users or registrants can
demonstrate that a produce shortage will re=
suit end their particular use of DDT, t&lcen
•with other uses, doss not create undus stress
oa the general or local environment, par"-
tlcularly the aquasphere. cancellation should
bo lifted. If no produce shortage will result
because other acreage Is suitable for thecs
crops. It shall still be open to demonstrate
that & transitional period Is required for
switching to new crops. If the Interim us® of
DDT doss not constitute en environmental
rlsls, final orders of cancellation for these uses
will be deferred until tho transition can bo
accomplished, provided assurances aro re-
eel-red &t the hearing that formulatoro sad
users will not permit bootlegging.
3. The switch, to methyl parethton. The
need to? a transition period arises also in con-
nection with thcso uses that ere being
canceled based on the existence of methyl
par&thlon.
The record before me leaves no doubt that
the chief substitute for most uses of DDT,
methyl persthloa, Is a highly toxic chemical
and. if mlsussd, is dangerous to applicators.^
ra It is o recognized policy of common law
nuisance and also of Federal environmental
legislation to afford affected producers a
transitional period for Implementing new
requirements.
0 Hot all of the possible substitutes' £o?
DDT are equally potent. For example, trl-
chlorofon, monocrotophos, malatnloa, and
carberyl. among others, are available to con°
trol many cotton pests; carbaryl is aa all°
purpose chemlca! for most cotton pests. It is.
however, abundantly clear that methyl para-
thlon will be widely used.
This, t»a t&6> •sirtuall? unanimous opinion
e£ fell &a witnessed. The lAtfoductl^a into
UBO ot ssg&aos&osrUiakon ba.% la tJ\a p*£u,
csTissd dacithe among UESIC ?;lio &ra un-
tratsed la thoU> oppilce>tioa wi<4 ths uatl-
mony &ad oshlbieQ of record point to tike ua-
happy saperleaco df aaveral years oj> whero
four deaths cscui-rcd at the Usio . -ethyl
paratbiOB bogaa to ba unad on tobacco, crops.
Other testimony aotod tho Increnee >n non-
fatal eucidoate n&d attributed almost one-
half reported pesticide poisonUi(jo to in-a
orgauop&oapbBte group. A ourvay conducted
Kites tho organophosphates bagaa to replace
chlorinated hydrocarbons la Texas suggests
e> significantly Increased incldoa&s ot polEoa-
ings.
That the skilled and trained ua>r may
apply oyganophoephates with complete safety
Is of comSort oaly if there is an onterly tran-
sition from DDT to methyl perathtoa so as to
tea In workers BOW untutored to, the ways
o£ proper use.
Z am accordingly making this order effec-
tive as o£ Dacombsp 31, 1973, insofar e& the
cancellations oS any particular use is. pre-
dicated OB tho avallcbUlty of methyl pe&&-
thloa no a? substitute. .In tho laontlia tbaS
follow tho Dap&rtmeni aS Agriculture, and
Stats extension services and sepressutetivas
EP& wlU have time to begin educating
oskSES who TTlil havo to uca methyl
paratbloa In future growing seasons. Sucfe a>
program c&n also introduco farmerc to the
less acutely toxie organophoeph&tcs, Uks
carbaryl, wlilcfe. may be satisfactory £cr many
USC3.
VI. Fa?, from being inconsistent with tho
general congressional mandate oS F1FRA, it
period of adjustment to tr&ls, U2or& of icathyl
poratbloa as ponult a nesciod traieiUoa
where no Bubstlfcutas exist la. o, Ic^lcai ciit«
growth of a, sensibla appllcatloa cf sls!c-'occa-
at analysis. While the Icgisl&tiva hl£tcf? aces
not address the specific problem bsfaro me—
tie timing o£ eaflcoilatlon ordefs=-tho hear-
ings Uiag preceded the enactment of .FETRA
UuUc&ts tia£ cenjfesalonal concern for safety
of the f nrBi«'=useg o£ pesticides was no less
thaa Oongresaf eollcitufie for tho oavlroa-
msat. While Congress ultimately struck a,
balance thag geaeraily .places th@ rick of
negligence on the applicator,, see Stt&ms v.
EPA, supra, it did so la Ugh* of aaxoranccn
that fasmers ara^fo? tiiel? own safety as well
G£ that of the environment being trained
In props? methods of application. Sao Hear-
ings before tSss SubcommiKeo OB D^irS-
mental oversight and Coasumdr*- Holsstoon
of the House CozasjJfcteo cm Aginrulirurs,
supra, ai 64, 03."
The riflU-boaoat; equation lo a dfa&aalo
one. Timing is E, vartablo in thag equation.
Whafc njfiy, la ths long rua, bs neccBSesy to
protect tho eartronmonfe could be & short-
term throat to hum&a health. This is erectly
the C&S9 bef oro me no^1. The benefits &f uslUK
. crganophosphates are a losg-rango benefit
ef J^'3
vcs. la tie ver? ihon. rua. ii-
Icas6 «wo courts have given express
reoognitiOQ to She similarity botwtsen the
regulatory schemes la ETFRA and tho Pood,
Drug, and Cosmetic Act. Sea Weirorfi v.
Ruckelsisaus, 439 P. 3d 508 (D.C. CW. 1S7X);
Hor-Am v. He?dia, 43S F. 2eS 1133. (7to Clr.
1970) (ea b&ac). I bolleve thaS tUo trail
Congroas intended m® to follow is marked
by ite directttro to. sect-lon 340 of th» Pood,
Drug, and Cosmetic Act, 21 U.S.C. jsctlon
3i3(f)(3) (1971). which permits the Secre-
tary to set an elfective dat« f or bia orders.
While similar language has aofc boja es-
pressly iaeludsd Us PIPBA, its omtesioa «aa
hardly be considered advertent in view of
the legislative history. See 3. Bopt. Ho. 573
(38ta Cong., first session 1963); S. Sept.
Ko. 1125 (G3tto Coug., eacond sessloa 19&4).
Tbe purpose of tho 1064 amendments was to
oilzain&to registratioa under protest.
tbs ^-
raJ^ht eusu^ w.r© sha usa c: ;.j- L-^.-
hiUeti whtTB no ai'.ira.V-i'-. -i u.\_»i
le o. factc? TTO aaust rcc;:c«u w.tjb. "^.4 t^.;-_r
ti^vlironmou'al reirulu^sry tsASuvs-i, «cta,-.-i
ivid pencils?, provliAo "JcaatUr.o" rw a:.
thijuitmont to now raqdlrczn&nts.*1
WbUe impatlenca la uaacrstiiacluiile Lr. r'.e -
ui' the j>asE history o£ C.21&?, v,-o rucst ::c-.
to lulled into tb.9 belief tiiat louTstand:-!:,-
problems can be corrected by ove?i\iijiit soiu-
feloaa. Today's decision provides a deanu:T«
answer to the status, of DOT rs^lstr&wcnj
and all concerned: to this Agency, f&m^ers,
manufacturers, the Departz&ent of Agrlsu:-
turc, and extension services: all must pro-
ceed with alacrity toward the Unpiement&ticn
of this order*
• • Z, SCOPE OP CASE
£. PR Koticss 71-1. 71-3. -?i-S canceled aU
registered1 uaas ©f DD"f and TDS.
B. Appe&la hove been received by 31 Tcr-
n«!fc-ixjrs who held registrations to? forrauiat-
tag DDT or TDE. These iorznulators ap-
pstarcd at this prociedlng' By D sin?le co«c3«!.
C. Wyco, Ine. and the Wallerstsin Co. a=i
S^arfe Bro'o. Kurseries hcve also appeared b7
tuparate counosl.
D. Tho Plane Regulation Division of the
Dapavtment of Agrtctslfuro was E> party to
this hearing as & registrant and th» Daparr-
jnent was ea intervsuor as te all uses.
B. 31i Lilly 6. Co. aafi H. P. Condon As Sonj
l &3«c.':i\rarsi Charsiftcis Aasc-
datlea; Sa-rtjcr^nentri. Ssieasa Fuad; tis
Club; WcsS Ji:ch;->a» Isavlrc2=ija:i:
couooal; and National Audusos
are iatosvanor parties.
O.' The folio-Bin^ canceled uses w>re ap-
psa!sd. afe issas la. tJils be&rlog^
&nd
1. Cottoa.
3. Haaaa (eryp Unas, caap) .
3. Swe«« potatoss.
4. Peanuts.
6. Cabbage, cauliflower,
sprouts.
6. Tomatoes. .
7. Kresh niBrJset corn.
8. Oweet peppers and plrnentoes.
9. Onions.
10. Garlie.
11. ObiQfaafeJsl grceahousn.
e»r fio not b-alloTO feha% tho ScTonts c:.-.
fruit's dec'.siou la. SUMits Phosptiorous ?i.--j
Co. v. E?A, eupra, proolufiofi me fro.-n ?s:<::-.:
into occouag the Bhort-tcrni dangers '.:-.?,:
cculd result frois IncrcA^cd UBS of avav-.y;
yiaratnioa by \intralncU usrra. Stffivrna hc:;!^
IL&6 a product is not "mbhrnnilod" oirr.p;.'
because ifc can be highly cSangcroua if th»
u&er la carelosa. ThJo reosonlu? Uces not.
tcwerer, compel mo to l2coro ths tmicair
of human beings to ba nc.zlljcnt •c'here u-s
as-3 dealing wltfe tio impleineatatlon oi sr.
order that wlJl Increase uca of a highly dar.-
gerouu Qubstonce. Evea negligence can bs
av.ntmised by training.
° While ths Esaminer excluded from ev;.
desics B study of tho DDT problem tot* tb u
^'genef undertaken by a, Committee of ti:s
Kational Academy of Sciences, It la app—-
priats to cots that Committee recoramei^oi
a phace-out period for tiie same reasor-s cui-
IJr.ed in, this opinion. WTi^e I reach rr:y cor.-
ciusio.is witioui; relying on tliit report's
factual findings and recommendations. £r.a
b
-------
1.
tary only).
a. c&bpto
X.
Uses
fiousa silc® safi bafe3
B.
77 .
ing:
a c*rctnogeale rts&,
V.
. .
B. crontrol of foody lion Ire prescrlptioa
ilngo. ,
It. CHEMKTAL PHOPSRTXZS OF DOS
A. Basic Endings:
l. DDT cnn persist in eolls for years anfl
even decades.
2. DDT can persist la aquatic eccsystams.
3. Because of persistence, DDT Is subject
to transport from sites of application.
a. DDT can be transported, by drift dur-
ing aerial application.
b. DDT can vaporize from crops and soils.-
c. DDT can be attacked to eroding soil
particles.
4. DDT Is a contaminant of freshwstera,
estuaries and the open oceanr, and it Is diffi-
cult or Impossible to prevent DDT from
reaching aquatic areas and topography aon-
adjacent and remote from tas site of
application.
B. Ultimate finding:
The above factors constitute & slab to the
environment.
FOOD CHATKT AKI> HSPACS
ox. Acnvrrv
A. Basic Endings:
1. DDT is concentrated In organisms and
transferred through food webs.
a. DDT <-an b® concentrated la and teane-
forred through terrestrial Invertebrates,
mammals, amphibians, reptiles, end birds.
b. DDT can be concentrated and trans*-
ferred la freshwater and martno planSten,
Injects, molluscs, other Invertebrates, and
flah.
2. Tlie accumulation In the food • chala
and crop residues results lu hitman exposure.
3. Human bclnga atore DDT.
B. Ultimate finding:
The above factors constitute an unknown,
unqu&ntl&able risk to mnn and lower
organisms.
r?. TOXICOLOGICA2. KitVKlTa
A. Basic findings:
1. DDT aGects phytoplankton species'
composition and the natural balance la
aquatic ecosystems,
2. DDT ia lotial to znany beneficial agri-
cultural Insects.
3. DDT can have lethal and sublethal ef-
fects on useful aquatic fresh we tor inverte-
brates, Including arthopods and molluscs.
4. DDT is toxic to fish.
3. DDT can affect the reproductive suc-
cess of Ash.
8. DDT caa have a variety of aublethal
physiological and behavioral effects on fish.
7. Birds can mobilize lethal amounts of
DDT residues.
8. DDT caa CRUSO thinning of bird egg-
shells and thuc Impair reproductive success.
0. DDT Is a potential humau carcinogen.
&. Experiments demonstrate that DDT
causes tumors in laboratory animals.
b. There Is some indication of metastasis
of tumors attributed to exposure of animals
to DDT in the laboratory.
c. Responsible scientists believe tumor
induction in mice Is & valid warning of pos-
sible carcinogenic properties.
d. There are no adequate negative experi-
mental studies la other mammallaa species.
e. There Is no adequate human epldcrnlo=-
. logical date on the corclaogcnlctty of DDT.
nor Is it llfeely tliat It caa be obtained.
f. Not all chemicals show the samo tuzno?-
igenlc properties ia laboratory tests oa
animals.
to
Xo E8T to usajia taf tas ceai?e£ a?
eettots tasocs ps/ris.
3. Cotton p£fit& Bfo boeosslng
DDT.
3. Mothyl paratoion and other orzanopboe-
pMato chemicals aro elective for the control
of cotton peats.
a. Methyl parathlon an<8 orgenophosphates
are less tosle to aquatic life thoa DDT.
b. Methyl pwatbton and organopaosphates
appear to bo less "persistent" and do not
build up In the fcod chain.
c. Methyl parathion is acutely toxlo by
dermal, respiratory exposure and oral in-
gestlon.
4. By using methyl parathloa of other
means of pest control cotton producers can
generally produce satisfactory yields et ac»
cep table cost.
6. DDT la considered useful to aavo iu re-
serve for public health purposes- ia disease
vector control. . .
o. DDT .3 considered useful as & gcoth-
prooang agent.
a. DDT 1 -?ot presently used by tlja mili-
tary f 01? treatment of fabric.
b. Alternatives exist;
7. DDT is useful for public quarantine
programs.
8. Quarantine programs are administered
by public officials and are a aonproprietary
uso of DDT.
a. This Is of little use in controlling' the
overall gypsy moth, problem.
9. DDT Js useful for controlling certain in-
sects that attack the crops listed In. finding
numba? (I) O.
10. Adequate substitute chemicals* namely.
saatfayl poratiilon and other organophes-
phatejs-— for the moat part — exist for con-
trolling tiie diseaaas thafi nttacfc tio eiopa
listed in- finding numbae (I)G except:
B. Sweet potatoes;
b. Heavy Infestations of com borer attack-
ing sweat peppers grown on toe Delmarve,
Peninsula;
c. Onions attacked by cutworms.
. 11. DDT Is effective fop controlling body
lice: - . •
a. KweU, e LJndnne product, is & sub-
stitute. ' • . ,
b. Undone registrations BES .being 'se=
• viewed. '
• 12, DDT Is used for exterminating bats and
mice by tiio military.
a. Fumigation and noncheialcal methods
ceo. guard against bat infestation.
b. Warfarla la e-ffective for exterminating
house mica.
B. THtlmate findings:
1. The uso of DDT la not necessary foe tiio
production of crops listed la finding (1)7
except that it may be necessary to produce
taoso cropo listed ia finding vio (a). (b).
and (e).
2. Noncrop uses of DDT fof moinpsooaag
and to control bats and mice are proprlutory
uses for which DDT Is not necessary.
J. MATTEBS
T6> SSETHTl,
A. Basic findings:
i. Many poisonings have beea attributed
to tho usa of sietliyl parathlon.
2. Untrained users of methyl parathlou are
frequently not sufficiently careful la its use
despite label directions.
3. Methyl parathlon can be used safely.
•S. Training programs are useful in avert-
ing the negligent use of methyl parathioa.
5. Methyl parr iliion is a substitute for mos*
crop uses of DDT.
B. Ultimate ending:
i. Methyl parathlon is dangerous to users
and presents H risk to them.
§. Aa oppertii£4t7 to t--ain ucsrrs •rtU aiinl-
Bilza Voft rtcas^'tia& bss^ cicfwa t&a nusn.be:
c£ escideata,
A. Ho tosctlgas i'v? tssa o£ DDT. evea If
£oU«y»ed. eaa ovsr tha long run compieuly
ellailnato DOT'S Injury to man or other
vertebrate talmas.
3. Ho warning or caution for u:e of DDT,
evea If followed, can over tho long run pre-
vent Injory to living man &r.d other verte-
bratu animals and useful invertebrate
anis'.als.
O. Toe present total volume of usa of DDT
la -ils country for oil purposes is an un-
acceptable risk to mtin and ills environment.
D.The use of DDT tn controlled situations
in limited amounts may present less risk
than usage ia greater amounts, bet still cou-
tamlnatcs the environment.
E. The public health program and quar-
antine uses of DDT by officials, when deemed
necessary, con be judged oa r.a appllcaUcn-
by-applicatlon basis by professionals.
F. A particular official use. la en isolated
instance, may be important.
CONCLUSIONS os* LAW
1. DDT formulations when labeled -r;:tSi
directions for use in the production of those
cre-po named in Sjadi&g (I) G and for use on
bats, mice, and fabric ore> "miabranded."
r/ltiila tho meaning of section 2(z) (2) (c),
Cd). and (e). of PTPRA, 7 T7J3.C. section. 135.
Z. DDT when labeled with directions "for
use by and distribution to only tT.S. Public
Health Service officials or for distribution by
0? on approval by tea T/.S. Public Health
Service to other health service ofP.dois for
control of vector dlssases, for rise by and
distribution to tlie Public Health Service.
USDA, aad military feu qruarantlns \:£.:;
to? uso la prescrlptloa dmgs to> be dls-
paosea only on a-nthorizattoa by a certified
medical doctor" along with the caution
printed in bold type "use for any purpose not
specified or not In accordance vAth directions
and use by unauthorized' persons U disap-
proved by the Federal Government: This sub-
stance Is harmful to the environment," is not
"mlsbraaded."
AoaosnsraAToa's OROOB RscAnaiMC DDT
•Cfder. Before ths Environmental Protec-
•aon. Agency. la regard: Stsveaa Industries,
Inc., at, tU. (Consolid&tcd DDT Hearings),
XJP. *t B. Docket No. 63 et al. .
Xu accordance with the foregoing opinion.
Savings and conclusions of law, use of DDT
on cotton, beans (snap, lima, ar.d dry), pea-
nuts, cabbage, cauliflower, brussel sprouts,
tom&taes, fresh market corn, garlic, plmen-
ioso, ta.coTamerci&l greenhousss, for raoth-
proodng and control of bats and rodents
are hereby canceled as of December 31, 1972.
Uso of DDT for control of weevils on storod
aweot potatoes, grcca peppers In the Del
Jiiarra Peninsula aad cutworms on onions
are canceled unless within 30 day.i uccra or
registrants move to supplement the record
la accordance wtln Pnre V of my c>p!nlon of
today. In such event the order shall be
otayt-d, pending tiio completion of the record,
oa tufnu ar.cl conditions sot by the Hearing
Examiner: Provided. Ti>at this stay may be
dissolved If interested users or registrants do
not present the required evidence in an
expeditious fashion. At the conclusion .of
sucS. proceedings, the Issua of cancellation
shall be resolved ia accordance with my
opinion, today.
Cancellation for ussa of DDT by public
health officials ia disease eoatro! provri—..•>
and by USDA aad the military for Kenl:a
quarantine and use in prescription drugs 13
lifted.
In order to Implement this decision -o
DDT ehc.ll be shipped ia interstate cos-
Wo. 131—Pt.I
VQU 37, NO. 131—FRIDAY, JULY 7, 1972
-------
mere* or within the District of Columbia or
any American territory after December 31.
1072. wales*1 1U label bear* In a prtcnlntnt
fithton la bold type and capital tetsen. In
a manner catlsfactory to the Pesticide* Regu-
lation DlvUlon. the IoU
-------
79
APPENDIX B
-------
ENVIEONMENTAL DEF. F., IMC
Clio n» 4
thiit imposition of the death sentence
cannot stand after Furman v. Georgia,
supra, which was decided after his sen-
tencing. In the light of Furman the
Government has recognized that a sen-
tence of death under 22 D.C.Code §
2404 is illegal and has suggested that
No. 72-1711 be remanded to the District
Court for resentencing only as to Tony
Lee's three convictions for first-degree
murder. The Court agrees.
Accordingly, these cases are affirmed
in all respects and No. 72-1711 is re-
manded for resentencing.
It is so ordered.
CAROLINA CHEMICALS, INC., et al.
O J III «IMMI m(IN)
fc— * *MK^«.^^A~_^r
ENVIRONMENTAL DEFENSE FUND,
INC., ct al., petitioners,
v.
ENVIRONMENTAL PROTECTION
AGENCY and William D. Ruckelahaus,
Administrator, Respondents,
Coahoms Chemical Company, Inc.,
Interyenors.
ENVIRONMENTAL DEFENSE FUNB,
INC., Petitioners,
v.
ENVIRONMENTAL PROTECTION
AGENCY end William'D. RuckeJshajss,
Administrator, Respondents.
COAHOMA CHEMICAL COMPANY
et a!.. Petitioner,
v.
William D. RUCKELSHAUS, Administer
tor, Environmental Protection Agency,
Respondent,
EDF et a!., Intervenora.
OUN CORPORATION, Pettttoiraer,
v.
William D. RUCKELSHAUS, Admtalstra-
tor, Envimnmentel
Aerencv.
v.
William D. RUCKELSHAUS,
. tor, Envlronmsntoi Protection
Agency, Respondent
W. R. GRACE & CO. eg a,^ Petitioner^
v.
\VilUam D. RUCKELSHAtJS, Environ-
mental Protection Agency,
Respondent.
OCTAGON PROCESS, INC, Petitioner,
• • v,. \ . .
William D. RUCKELSHAUS, Administer
tor of the Environmental Protection
Agency,, Respondent.
72-1548, 72-1690, 72-2142, 72-2183,
73-1015, 73-1088, 73-2070.
United States Court ol Appeals,
District of Columbia Circuit.
Argued Nov. 5, 1973. '
Decided Dec. 13, 1973.
Petitions for review of orde? of the
Environmental Protection Agency which
cancelled almost all registrations for use
of DDT except for limited public health
and agricultural pest quarantine pur-
poses. The Court of Appeals, Wilkey,
Circuit Judge, held that such order was
supported by substantial evidence when
recot-d as a whole was considered, and
that even though ac^iora of Environmen-
tal Protection Agency would have a sub-
stantial effect on human environment,
filing of a specific report was not re-
quired under the National Environment
tal Policy Act of 1969.
Affirmed.
1. Agriculture
Provisions for judicial review under
both 1970 and 1972 Federal Insecticide,
Fungicide and Rodenticide Acts require
court to determine whether findings.of
fact of the Administrator of Environ^
mental Protection Agency are based
upon substantial evidence when consid-
ered on record as & whole. Federal In°
-------
81
sectieide. Fungicide and Kodentieide
Act, § 4(c, d), T U.S.C.A. § 135b(e, d);
Federal Environmental Pesticide Con-
trol, Act of 1970, |§ 2(bb). 3(e)(5)(D).
7 U.S.C.A. §§ 136(bb). 13Sa(e)(5)(D).
g. HefflBtto sad EmvflirD!niinrw!m6 O^SS-S
"Substantial evidence," for purposes
of reviewing findings of fact of Admin-
istrator of Environmental Protection!
Agency; means such relevant evidence as
. reasonable mind might accept as ade-
to support a conclusion. Federal
eral Insecticide, Fungicide and Rodcnti-
cide Act, §§ 2-13, 4(c. d), 7 U.S.C.A. §§
135-13§k, 135b, (c, d): Federal Environ-
mental Pesticide Control Act of 1970, §§
2(bb), 3(c)(5)(D). 7 U.S.C.A. §§ 136
(bb), 13Sa(c)(5)(D): Reorganization
lo. 3 of 1970. 5 U.S.C.A. App.
tet, § «(c, d), 1 U.S.C.A. § 135b(c, d);
Federal EnvSroiramentsl Pesticide Con-
;rol Act of 1970, §§ 2(bb). *g&3
Evea- though Administrator of En-
vironmental Protection Ageney decided
contrary'to conclusions of hearing
weight t© hearing examiner's report,
where the administrator reviewed report
of examiner and exceptions to report
filed by Environmental Protection Agen-
cy staff, the administrator decided case
on basis of record developed in the hear-
and specially prepared summaries, and
case was one where demeanor of wit-
nesses was not particularly important
and where examiner himself had n© par-
ticular expertise.
Order of Administrator of Environ-
mental Protection Ageney which can-
celled-, effective December 31, 197i, al-
most all registrations for use of DDT,
except for limited public health- and ag-
ricultural peat quarantine purposes, was
supported by substantial evidence, when
record as a whole was considered. Fed-
O23.10
Even though action of Environmen-
tal Protection Agency in ^withdrawing
DDT registrations would have a sub-
stantial effect on human environment,
filing of a specific report was not re-
quired under the National Environmen-
tal Policy Act of 1963, where lengthy
hearings were held during which public
comment was solicited, and a wide scope
of environmisntal aspects were consid-
ered, and the environmental impact of
the action, possible adverse environmen-
foetweess long and short term
uses and goals, and any irreversible com-
mitments of resources all received atten-
tion during the hearings and decision-
making process. National Environmen-
tal Policy Act of 1969, | 102(2) (C), 42
U.S.C.A. § 4332(2) (C).
an agency is engaged pri-
an examination of environ-
mental questions, and substantive and
procedural standards insure full and ad-
equate consideration of environmental
tissues, formal compliance with National
Environmental Policy Act of I960 is not
necessary, and functional compliance is
John F. Dienelt, Washington, D. C.,
with whom William A. Butler, East Se-
tauket, N. Y., was on the brief for peti-
tioners in Nos. 72-1548 and 72-1690 and
Environmental Defense Fund, Inc., and
ethers, petitioners in No. 72-2142.
Robert L. Ackerly with whom Charles
A. O'Connor, III, Washington, D. C.,
was on the brief for petitioners in Nos.
72-2142, 72-2183, 73-1015 and 73-2070.
Stephen F. Eilperin, Atty., Dept. of
Justice with whom Walter H. Fleischer,
Atty.,, Dept. o£ Justice and Blaine Field-
-------
"82
ENVIRONMENTAL DBF. F.. INC. v.
fltt- n* 4S'J V2A
ng, Atty., Environmental Protection
kgency, were on the brief for respond-
>nts. Alan S. Rosenthal, Atty., Dept. of
Fustice and Michael C. Farrar, Atty.,
Environmental Protection Agency also
entered appearances for respondents.
Charles M. Crump, Memphis, Tenn.,
ind Walking C. Johnston, Montgomery,
Ala., were on the brief for intervenors.
Before TAMM. ROBINSON and
WILKEY, Circuit Judges.
WILKEY. Circuit Judge:
Coahoma Chemical Company, the En-
vironmental Defense Fund, and other
parties seek review of the 14 June 1972
Order of the Administrator of the Envi-
ronmental Protection Agency (EPA)
which cancelled, effective 31 December
1972, almost all registrations for the use
of DDT, except for limited public health
and agricultural pest quarantine pur-
poses.1 Coahoma, along with other
producers and users, challenges the Or-
der as going too far in banning most
uses of DDT; the Environmental De-
fense Fund (EDF) challenges the Order
as not going far enough by allowing a
few uses to remain.
I. AGENCY ACTION
After a lengthy administrative review
of DDT, a potent pesticide,3 the Order
ENVIRONMENTAL PRO. AGCY. 1249
11247 (1073)
of 14 June 1972 was promulgated. The
EDF first sought cancellation of DDT
registrations under the Federal Insecti-
cide, Fungicide, and Rodenticide Act
[FIFRA] in October 1969.5 More than'
a year later, and after two coses chal-
lenging the lack of Government action
had been brought in and decided by this
court,4 on 15 January 1971 • the Admin-
istrator of EPA issued cancellation no-
tices for all registrations of insecticides
containing DDT. However, no suspen-
sion of use was required at this time.
EPA began evidentiary hearings on
DDT in August 1971. A month later an
Advisory Committee, appointed at the
request of the registrants (t. t., users
and producers) of DDT,* issued a report
confirming the hazards caused by DDT
and recommending suspension or rapid
decrease in use. In one of several pre-
liminary judicial skirmishes between the
parties, this court ordered EPA to re-
consider its decision not to suspend use
of DDT pending the outcome of the can-
cellation proceedings;1 reconsideration
resulted in no change by EPA. We lat-
er in effect gave EPA a 15 April 1972
deadline before which to conduct mean-
ingful administrative proceedings.*
The EPA hearings terminated in
March 1972, after seven months of testi-
mony from a broad spectrum of the pub-
I. Environmental Defense Fund (KUP) Ap-
ttt SO.
J. Tim chemical nnme for DDT Is 1,1.1-tri-
cldoro-2,U-bi* (pchlorophenyl) ethane. EDF
Appendix at 105.
3. 7 U.S.C. f§ 13!>-135k (1070). Orieinally
K1K11A wo* enforced mid administered by
tin- Secretary of Agriculture. However, a
rcorKiinlxution in 1070 |iliu*d responsibility in
the, Ailr.iini.ttrutor of KI'A. See Itvorunnizu-
tioh I'lun No. 3 of 1070. in A|>!*mHx to Ti-
tle 5. U.S.C.
4. Knvironmctitiil Ik'fciwe Fund v. Ilnrdin,
i:« «.'.s.App.r>.c. :wi. 4-js VM 1093
-------
125© .
83
489.FEDERAL, REPORTER, 2ei SKIUBS
Jic. and in April the Hearing Exnmincr c
filoH his Recommended Findings, Con-
tusions, and Orders."11 The Hearing?
Examiner concluded that all cancellations
notices should be withdrawn, and regis-
trations of DDT should continue, except
fop non-military mothproofing and ODD
fruit spray."
Th« Administrator chose to review
case personally (instead of
this as he normally would to- the
Officer),18 and after orsl argument
written briefs concluded ora
1972 that DDT was sufficiently
ous to require its use to b®. banned
most purposes. The Administrates"
Hayed the effective date of his Ordtes-
sis months, so that users of DDT c
be educated in the proper ins"ld
tiora lies in the Federa!
gteide, and J&od@fstic8d£>
of every
f sold in
the United States.20
be denied if the sub:
ily with the provisions of
not com-
Aet,1^ and
in the statute to have
IS
occurred, "if
ox an
when used as directed or in accordance
with' commonly recognized practice it
shall be injurious to living' man or other
vertebrate animals, or vegetation, except
weeds, to which it is applied, or to the
person applying such economic poisons."
formulation of this require-
ment wn» iiuorjiomtcd in the Fwlnral
Knvimnmcntnl Pi'sticicle ('ontrol Act of
1972, which ri'<|iiirps deniitl of iTKintrn-
tiom unless the sudstnncc "will perform
its- intended function %vithout unrea-
sonable adverse effects on the en-
vironment," DD and unless "when used
ora accordance with widespread and com-
co^sjiged practice it will not
cause unreasonable adverse ef-
fects 0m the environment."I0 The
FIFRA provisions further require that
the order of the Administrator cancelling
evidence of record developed at a
if a public hearing is held* and
tfa® ®i?der musfe set foptfe detailed find-
5irass ©f fac*.20
The Adrasaiatrator's Order is chal=
on two grounds: . (1.) 5s it based
substoraOal evidence in the record;
doss it eompJy with the require-
of tfe© National Environmental
PoSiey Act (NEFA)? For the reasons
explicated sra Farts II and III below, te
both questiems our answer is affirma-
tive.
MTTff TB^ffiT'Tr A 7 W C*^yV W^T17 (T\ W 'ff*7JTC<) A n
. JUDICIAL REviEw OF TIIJS AD-
established in the substan-
tive legislation are the standards for ju-
review. Once the Administrator
concerning the
registration of a pesticide, that order is
to the United States Court of
The FIFRA statute directs
the Court of Appeals to sustain the find-
9. Tlie official Jitle fop She Hearing
is now AtlminiHtpajH'e Lnw Jurfgp. Kee ST
g. 4R7ST (15172) : 5 C.F.R. 9 030.' Sub-
5ra KDP" A|t-
02. Kre Brief off Rcs>iton.
Ruchelshans, ee ol., ae 21.
JSntrironmental
10. EDF Appendix at SCO.
US. Esaraisiep'a
e 20T-S18.
03. Nee Brie2 of
De^easa Fuml, ee B!., at 30.
JO. TU.S.C. 8 133b(o) (19TO).
09. ? U.S.C. B I33h(c).
IS. 7U.M.C.gl3Tm(n)(5).
07. 'f L'.S.r. e 133(x)(2)(g).
08. ? U.S.C. S i:»fiu(cM5){C)
p. HI.
19. I U.H.C. 0 13nn(v)lR)(D). The statute
jIuKffimsj "mai?easnaiRlijQ oiivepse effc»'t»" aa
"any isat-eoatinaCils rish to man or the envi-
POBBOiaetaf, tubing into ac-'-'jiint the>
serial, QBil eaviraiimeneiil coats ami
of tliQ UKQ o£ Qny jtcgiicidc." 7 L'.S.C.
8. T T.S.C. 8 1S.%(c) (J07U).
-------
. 1251
CUo- MM J.S55 J'.SiS I2S7 H'J7:i(
ings of the Administrator wiitlhi respect based on aim extausinMifjanly voluBiisaeus
to questions of fact if "supported by record.s<) "Substantial evidence00 was
substantial evidence when considered ora lotrag ago definod by Chief Juadke
the record as a whole."8a The 1S72 Hughes as '°ra©?s thaua a raws seiratilla.
amendments furthest' elaborate the seop® It means suefe iretevasnt evMeiae® as a
of judicial review: ; i?@as®mable miw& saagM aeeigpfe as
The court shall eonsidei? al! evidieraee «s«sate to supp©!?fe a
of irEsord. Th© oi?deir of fch® Adminis- "Sated Sdisosa C© v. NL^B.83' AM stage
trafcor shall be sustained if it is sup=
ported by substantial evidence when- fe® fionsidere^l as
coiaaidered on the reEoed as a whole.QS
The two versaons provid®. standards of
review-which are somewhat different, ira
quires the court to support orders of the
Administrator which are based om sub-
a
was enacted and'effective m 21 Octob®E cnt cholcsjjafi the matt®? beea before
1972, fouir months after the Administrs- «ow.
tor issued his Order 5m question here, The Supreme Cerast has m@pg reegBtly
but well -before our judicial review, recognised in Coxasolo'v. Federal Mari-
While the parties seem to assume that time- Coramissi©® that there may b® in-
the 1970 version is controlling for pur- consistent conclusions which easa be
poses of our review,83 the 1972 statute drawss frosa the sam© yesord, each ©f
has no provision denying application which may b© supported by substantial
to judicial review of prior orders of evidence. Thus, "substantial evidence"
the Administrator. We read the X972 5s something less thara the weaghfe of
amendment as establishing a standard tee evidene®. and the possibility of
effective for judicial review sommcncins drawing two ineenaistent eaneiusaons
after 81 Octeber 1972, and therefore ap° - £rom jne g^adene© does net psweafc aa
for judicia? review under both the 1970
and 1972 language dearly require the The Supreme Court went ora t© poirafc out
eourt to determine whether the findings that the substantial evideae© teat "frees
of fact of the Adrasnistratoi? are based the reviewing ' courts ©2 tho t5m©-con=
upon substaatial evidence when consid- au?mng &n<& diffieulfe tesk ®f weighing
ered on the reeord as a .whole. Thus the evidence, J6 siv<§3 prepe? irespect to
wo must apply a traditional type of the expertise o£ the administrative tri-
stsbstantial eva'denee test, albeit one buna! and it helps pi?®mote the uniform
21. 7 II.S.U. 2 13Sb(d) (1070). Uriof o£ PeiSttewsp, CootiOESQ Clicmfa-al Co.,
-i K
22. 7 U.S.C. 8 laitoW (S«J>1>. H. t!)7-2».
„»,....,.,, „, . „., . . S3. :«>Tt U.S. 1U7. 523. G!t S.Ct. 'JOfl, 'J17. 83
23. Uriel o? 1'etitiuuer, (.'uuluunu OUeraniol ... ..,
t'ifc, oe 35; Mriefl-«f J'fciHiouei?. KDS-% as KL '**
„„ , . „, . , ^ ,,m „ : »80 U.S. •&?•»,. 48S, 71 S.Ct. 423. 4C4, 05
20. Iniriuu asveio iiioBHia oa lusoriiiga, I'Ja wit- „ ... ,_
SraHtfy laud U)tS vskibiln ' t*
ovro pliw-wl in evStleairo. Tlio tetmsatrijiij uf 2?. 3K3 U.S. K07. S 13,
-------
.1252
489 FEDERAL REPORTER. 2d
85
application of the statute." s" Other
court? have stressed that where ques-
tions involve a special expertise of an
agency, iuch as in detailed scientific
proceedings, the agency deserves special
deference front the courts, although
careful review 13 of course always
required.**
In the case at bar our task is made
somewhat simpler than the agency's by
adhering conscientiously to the proper
scope of judicial review of administra-
tive action, t. «., we as a court are con-
fronted with a problem in administra-
tive law, not in chemistry, biology, medi-
cine, or ecolofv It i." tho administra-
tive agency which has been called upon
to hear and evaluate tea ' r.ony in all sci-
entific fields relevant to its ultimate
question of permission or prohibition of
the sale and use of DDT. The EPA Ad-
ministrator had an opportunity to make
a careful study of the record of seven
months of public hearings and the sum-
maries of evidence prepared for him,30
heard oral argument, and now has ar-
rived at a decision to ban most uses of
DDT. It is hia decision which we must
review; we are not to make the same
decision ourselves. We are concerned
with how he did it and on how much evi-
dence. Since there id. no challenge to
procedure here, our problem narrows
down to whether his decision is support-
ed by substantial evidence based on the
record as a whole.
B. The Evidence
A review of the evidence in this case,
as summarized by all the briefs, indi-
cates that the situation is as described
in Consolo: there is a great mass of of-
ten inconsistent evidence which was de-
veloped at the hearing; this evidence is
28. Ibid.
29. S«e, t. 0-, Denf«ch v. United States Atom-
ic Energy Comma., 130 U.S.App.D.C. 339. 401
404 (1968).
30. The public disclosure of these summaries
IN nought under the Freedom of Information
Act, 5 U.S.C. I 002 (1970), in a companion
'substantial enough to support the con-
clusions of the Administrator, although
it possibly might support i:ontr:iry con-
clusions as well. Considering the evi-
dence in the record as a whole, we can-
not say that the Administrator's deci-
sion wns not based on substantial cvi-
dence, even if the hazardous nature of
DDT has not been proved beyond a rea-
sonable doubt. Sufficient evidence has
been adduced to show potentially groat
dangers from DDT, and the Administra-
tor's decision to cancel the DDT regis-
trations is well within his statutory au-
thority.
Specifically, the Administrator states
that DDT is hazardous because of sever-
al of its inherent properties: its persist-
ence, mobility, and lipid solubility.31 He
contends that the alternatives to DDT
do not have such properties, although he
concedes that the alternatives may be
more acutely toxic in the short nin. He
presents detailed evidence concerning
the human hazards which may arise
from DDT (carcinogenicity and muta-
genicity of DDT), and also details the
environmental hazards (effects on phy-
toplankton, beneficial agricultural in-
sects, aquatic invertebrates, fish, and
birds).3* He concludes that an unac-
ceptable risk to man and his environ-
ment is posed by continued use of
DDT.M aside from the few carefully
controlled uses concerning public health
and agricultural quarantine purposes,
which he permits.34
t
These findings and the evidence on
which they are based are vigorously
challenged by Coahoma and other DDT
users. While their evidence might be
sufficient to have allowed the Adminis-
trator to have decided the other way,
and permit DDT to continue, their evi-
•
case, Montrose Chemirnl Corti. v. Riicket-
ahnua, Nos. 73-1443 and 73-1444.
31. £cc Ilrief of Respondent, RuckclHlmus. tit
28-43.
32. See id. Ht 43-85.
33. fife ill. at SO.
34. See id. at 10>>.
-------
86
> 913?. ?., SW©. v. gXJVmOBJMSWMo PS®. A©0Y. 1253
CTGo oo 8*9 t'.gtS S2-OT (d©?38
demee • is not stu'indssjfc to vitiate the ae- ly in nn ojwraJoiB % Judge Tomm in
tufflH decissomi ©£ the Administrator MS raofc Cinderella Camst? and FtnssMras Schools,
havirag beets based on gufostatiaE evi- Inc. v. FTC, this Circuit held thafe the
denes in the resetrd as si whole. • ®K<2ra£ resord, heararajf essssaiaGi?'s-'ir(ip®Ki,
We d© not require thafe Hh© eEaR5S0S!?''s ^M ^^ ^^e BPA atefg. H© desided
fissdings be givess raors weight thaw 'm cas® ®ra tb« feaa5a @2 th<§ pe@@i?dl dsv
sreasom and in the Sight o£ judicial es- afc fcfse Marines,, oddifeteal briefe
tinl evidemce" standard is not mod5<- summarsga.30 Tte ess® appears to be
in a0y way when the Board .and om where the toaeaiaop ®2 witaisases is
exsmiwsi? disagree. We intend mo* nartieuIarSy DsapoFtaa^ and where
to recognig® that- evidence sup= toe examine!? himagl? had 00 pirticu-
' porting' a conclussotii may be less sub- lar expertise, foi? he was a coal
atantial when an ' irapartiad, expsri- mine accident spssiaHst.30 The Ad«
enced esaminetr wh© has observed the miniatvator eould derive a prefer
witnesses and lived with the case had cSatiom o£ the 'egfet ©
drawn condwaioifiis diOerent from the tion «^ ih|s ess©- by a remdasiB
Board's thara whesa he has reached the "-'coa-d. Thus we conetad® that
aarae conclusion . . . Th® sig- «5«n6 weaghfe was givsts to the examiner's
njjficance o£ his report, o£ course0 de- report. . .
pcnds largely am the importance of JK another aspest of-' the queafeiora o£
credibaSity in the particular case.33 th@ substantiality • o2 ' thQ- e.videne©t Coa=
Later, m FCC v. ASlentowR Broad- hos@a0 et ah, urgQ -that the Administer
casting Corp.30 the Court indicated that tor's ftndingg ai?@0 insmffkieBt in that
where -responsibility for decision was they are based to m larg© estenfe on data
placed on the Board, it would be 5neon= which does FJ©£ dir©et8y and spesifically
sistera't to require the Board to adopt aim relat© to the ass ©£ DDT t® eosabafe the
gjsaraineF°§ findings umJeas rejeetioitii boll' weevil asd the boSlwopsa ia the cot-
would be "'clearly erroneous." However, ton growing areas oS the Southeast/0
the Court did n©£ elaborate on the prop- It 5s true that ssmeh o£ thg evidence m
gr standard to be applied. . Subsequent* the record conesrnang dangers of DDT
3. 3-MJ U.S. 4T-J, 408. ?H .S.C». 4.10. -dCM. 8K5 osi!!o«ii ji£«ts. iiffiuiarily the fallwerasi. In
£«.K»I. -855$ (1051). ewe. nr JcusU TO% oS nil 8»DT is uswl iia tlia
8. MA U.». MM. TO 8.C». 809. l» I..K.I. 114? «H»«"«-K»wlnB O»M. m|twi»lly lha Mouth-
-
Ml. Tlios 8iijspvaimaiiai, Ntatiunal (.'ullun Conn-
37. ia«S U..S.AH«.S>.C. '15i IS?. 4U5 >'j;a SKI. ,.» „? Amerieo. ee Qt.. HUJBziraa Ira ihatr HrieK
SB.. NOT nine M. scfp
-------
1254
87
•189 FEDERAL REPORTER, 2c'
u
1:.-
does not specifically relate to this onu
area or to. tho use on cotton crops.
However, it is not necessary to have cvi-
d^nce on such .1 specific use or area in
order to be sole to conclude on the basis
of substantial evidence that the use of
DDT in general is hazardous. The Ad-
ministrator has .pointed to evidence in
the record showing that use of DDT ex-
cept in minuscule amounts in highly con-
trolled circumstances should be curtailed
because of unreasonable risks to health
and the environment.41 Reliance on gen-
eral data, consideration of laboratory ex-
periments on animals, etc., provide a
sufficient btaaia to support the Adminis-
trator's findings, even with regard t *.
each special use of D D A .
On the other hand, EDF challenges
the Administrator's decision to allow ti.se
of DDT in controlling certain public
health problems or in agricultural quar-
antines as not being based on substan-
tial evidence. Specifically EDF con-
tends that there is no need to retain
these uses of DDT, and that the usual
dangers of DDT are present in these
particular uses.42 The Administrator
finds that these uses may be necessary
to combat potential, severe public health
problems, and so DDT registrations for
these purposes should be allowed. The
necessity arises from the fact that alter-
native pesticides are also under EPA re-
view, that situations may arise where
the alternatives are not effective,43 and
that DDT must.be available. Because
the allowance of continued registration
does not mean continued use, except
where certified to be necessary, the Ad-
ministrator concludes that the benefits
of continued registration outweigh the
n'sk.s inherent in such a minuscule tisn.
This vi«'\v has support in the record as a
whnle. and thus satisfies the .substantial
evidence test.
|S] The entire Order of the Admin-
istrator is supported by substantial evi-
dence when the record as a whole is con-
sidered. Under a proper application of
the substantial evidence test, as formu-
lated by the Supreme Court and by this
Circuit, we affirm the Administrator's
Order. We stress again that from an
administrative law perspective we sim-
ply conclude that the Administrator's
Order is adequately supported by evi-
dence in the record. We do not decide
whether we, ourselves, would ban DDT.
nor should we so decide. We have, how-
ever, carefully reviewed the decision of
the Administrator, and conclude that it
should be affirmed.
III. COMPLIANCE WITH THE NA-
TIONAL ENVIRONMENTAL
POLICY ACT OF 19G9
The second challenge to the EPA's ac-
tion raised by petitioners Coahoma
Chemical Co., et a)., concerns the failure
of EPA to file a specific report under
the National Environmental Policy Act
of 1009 (NEPA). That statute requires
that
to the fullest extent possible .
all agencies of 'the Federal Govern-
ment shall . . . include in every
recommendation or report on propos-
als for legislation and other major
Federal actions significantly affecting
the quality of the human environment,
a detailed statement by the responsible
official on —(i) the environmental im-
.pact of the proposed action. . . .4*
41. Kfe notea 32-34. ituprn. .• For the KPA'jt
argument rtiiwtnl towards i-nttnn tMwtx. *rr
Brief of Respondent; Itiirkelxhniia. at SIV-OO.
42. Brief of Petitioner, EDK, nt 01-02.
43. Brief of Respondent. RnckoUhniis. at
106-107.
44. 42 U.S.C. 5 4332(2) (C) (1070). Tlie
statement Uf minimi to inclmlft conxiilr-ni-
tion of
(i) the environmental import of the pro-
posed action.
(ii) nny iiilvrrxi* environmental rffit-ts
which rnniiot IN* nvoir«>-
iion.il lie implemented.
(iii) alternative* to the ]>ro|ioxef
long-term proilnrfivlty, ami
(v) any irreversible ami irrrtriitvulili*
commitment* (if rr«oiim-i which woiiM 1m
involved in lh» prn|N>-i*l notion should it
he implemented.
Id.
-------
88
ENVIRONMENTAL DBF. T« INC. ?. ENVTEONMENTAL PRO. AGCT. 1255
Cite •* *» F.M 124T ( 1073)
This has been interpreted to require an
agency to prepare an environmental im-
pact statement whenever the agency's
proposed action will have a significant
effect on the environment.
There is little doubt but that the ac-
tion of EPA in withdrawing DDT regis-
trations will have a substantial effect on
the human environment—indeed, that
wus the very purpose of the EPA action.
The court is asked to consider two other.
somewhat interrelated questions con-
cerning NEPA. First, is the EPA an
• agency subject to the requirements of
the statute when it undertakes environ-
mental actions such as the cancellation
of DDT registrations here? Second,
has EPA in effect complied with the re-
quirements, despite the lack of a formal
NEPA impact statement?
Petitioners Coahoma Chemical Co., et
al., urge that EPA is not exempted from
the NEPA requirements. They stress
the statutory language requiring ALL
agencies to comply, and note that there
is no specific language in either NEPA
or FIFRA which exempts EPA in this
or any other set of circumstances. They
note two District Court cases which in-
dicate that all agencies, even the envi-
ronmental ones, are covered by the
NEPA requirements.43 Furthermore,
they contrast the action of Congress in
providing a specific exemption for EPA
in the Federal Water Pollution Control
Act Amendments of 1972," with the ab-
sence of a provision in the 1972 FIFRA
amendments enacted three days later.47
On the other hand, EPA contends that
NEPA does not apply to the "environ-
mentally protective regulatory activities
of the Administrator conducted under
the registration cancellation provision of
the FIFRA."« Instead, EPA believes
that the case is controlled by this Cir-
cuit's decision in Portland Cement Ass'n
v. Ruckelshaus." EPA limits its brief
to the contention that NEPA does not
apply to thit type of action, although it
states in footnote that perhaps NEPA is
not applicable to any of EPA'a environ.
mentally protective regulatory activi-
ties."
Portland Cement involved EPA's pro-
mulgation of stationary source stand-
ards for cement plants pursuant to the
Clean Air Act.81 The EPA action was
challenged in part because the agency
did not file a NEPA statement in con-
junction with the promulgation of stand-
ards. Judge Leventhal noted that
"there is a serious question whether
NEPA is applicable to environmentally
protective regulatory agencies. There is
no express exemption in the language of
the Act or Committee Reports." M We
analyzed the pertinent legislative histo-
ry, concluded that it was inconclusive,
and then looked to the purpose and poli-
cies underlying NEPA. The goal of
NEPA was of course to protect the envi-
ronment, which it did through "a broad-
45. The two cases noted by Coahoma are Kal-
ur v. Rwor, 335 F.Suvp. 1 (D.D.C.1971) [re
Corp* of Engineers], and Anaconda v. Ruck-
elslmu*. 3M F.Sup|i. W)7 (D.Colo.1972) (re
EPA]. The first of these case* was dis-
missed as moot hy thin Circuit. See Port-
land Cement Asa'o v. KuckelshauM. 158 U.S.
APD.D.C. 308, 318 n. 41. 486 F.2J 375, 383
n. 41 (11)73). The second case wan ohnervci)
by us in Portland f.'ement to have a "myopic"
view. Ibid.
46. 3T! U.H.C. i 1371 (c) (Supp. II. 107:1).
47. The FIFRA amendment* ore contained in
the Futlerul Kiivironineutal Pesticide Control
Art of 1!>72. 7 U.S.C. < 180 (Supp. II.
1U72). A similar argument was put forth in
the Portland Cement vaite, but wax dismissed
by tlte court there an providing a "hazardous
basis for inferring tbe intent of the earlier
Congress." 158 U.S.App,D.C. at 315. 488
R2d at 382. citing to United States v. South-
western Cable Co.. 302 U.S. 157. 170, 88
S.Ct. J094. 20 I*EA2d 1001 (1968).
48. Supplemental Brief of Respondent Ruckel-
shaus, at 2.
49. 158 U.S.App.D.C. 308. 486 F.2d 375 (1973).
SO. Supplemental Brief of Respondent, Rack-
etahauN, ac 2-3, n. 1. The EOF supports
the limited stand of EPA. Supplemental
Urief of Petitioner, EOF, at 13.
31. 42 U.S.C. § 1857o-6 (1970).
52.' 158 U.S.App.D.C. at 314. 480 F.2d at 381.
-------
^0^$!L •--~~-'
ly applicable measure .that only provides
a first step." M In Portland Cement we
thoughC that this goal might best be
served by exempting certain activities
fqom the forma! requirements of filing
NEPA reports. While we were not
there willing to decide whether there
was a broad exemption for all EPA en-
vironments! actions, we concluded that
the actions taken,'in that case under the
Clean Air Act were exempt frora NEPA,
because the Clean Air Act "requires the
functional eqiaavslwnfc of'a NEPA impact
statement."*8 The Clean Air Act re-
quired the Administrator to supply a
statement of reasons for his proposed
standard, which statement should set
forth ths es3viiv,..,7»er»t'' considerations,
both pro arad con, and thus the Act
seemed to "strike & workable balance
between some of the advantages and
disadvantages of full application of
for publie eesftment was provided, as was
opportunity for court
[S) The rationale w© first developed
in Portland CemenZ is applicable here as
weiSp and ara exemption from the strict
letter of the NEPA requirements is thus
appropriate. The explicit language in
gistered if tlhey wil! bo injurious to man
and his environment. The substantive
standard established by the statute
places great emphasis en tfte quality of
33. Id. at 380, 4WJ K.2it aft 383.
30. Id. at 31?. 4M F.2rl nt 3&8.
33. III. at 31J», late
in the iiroceedings mnltes the Coahomn jmsi-
tioa look snore like a rialEyisig tactic thara a
real roncera with the environment. HOCT-
CTCI?, our recent decision in Arisossa Publia:
Service Co. 7. FPC, S3? U.S-Aiip.D.C. 2?2,
2Sn, -sal F^il 32TS, J2S3(U»?3).notej? that
"the ennliriesn o£ eho jiartieo cannot excuse an
Qgeacy from coaplyiag witta its respamsibili-
tiea uadei? NBPA."
man's environment. Additionally, the
procedural standards provide full oppor-
tunity for thorough consideration of the
environmental issues, and for ample ju-
dicial review. In this particular case,
lengthy hearings were held, during
which public comment was solicited, and
a wide scope of environmental aspects
were considered. Thus the functional
equivalent of a NEPA investigation M/as
provided, for all of th« five core NEPA
issuer were carefully considered: ' the
environmental impact of the action, pos-
sible adverse environmental effects, pos-
sible alternatives, the relationship be-
tween long- and short-term uses and
goals, and any irreversible commitments
of resources—all received attention dur-
ing the . hearings and decision-making
The law requires no more.
When it is clear that the NEPA objec-
tiosas. sir® being raised' by parties who
have had ample opportunity to express
their views,87 when there has been func-
tional compliance, the Portland Cement
rationale should certainly apply, and the
agency action should be exempted from
the strict letter of NEPA requirements.
As we wrote recently, "To require a
'statement,' in addition to a decision .set-
ting forth the same considerations would
be a legalism carried to the extreme."80
Our recent decision in Arizona Public
Service Co. v. FPG,80 which requires an,,
98. ° Jnternntionnl Harvester Co. v. Ruckcl-
ohaua. 155 U.S.App.D.C. -Oil, -440.. 47S F.Uil
815, 030 o. ISO (1073). The court in Inter-
nalinnaS ] I or mater noted tlmt
thn requirements of NEPA should be xub-
jes-t to a "fou.ttnictiou of rcn.<9oiirableness.'°
Although we do not rench the question
whethe? EPA in aucomnticnlly anil com-
ploeely esemtit from NEPA, we nee little
need in requiring a NEPA statement from
QB agency u-hooe reison d'Stre is the pro-
tection o£ the environment and whose de-
cisioa OB ouapeusioB is necessarily iafused
n-itli the environmental considerations so
jieetineat to Congress in dcaisssiag the
otnttstof?
157 U.S.Ai>|».I).C. 272. 4S3 K.2J 327:5
-------
NATIONAL RLTY. ft C. CO.. INC. 7,
fit.- a» IM> V.
agency to at least file a statement of
reasons as to why an impact statement
is not necessary,** >« inapposite to the
case at bar. In Arizona Public Service
the Federal Power Commission did not
took carefully at the environmental ques-
tions, but merely concluded in one sen-
tence that there was no environmental
impact.*1 That is a far cry from the
instant case, where the whole focus of
the agency action has been on the envi-
ronmental aspects of the use of DDT.
The reason, for the failure to file a for-
mal NEPA impact statement need not be
explicitly stated here, for it is apparent
on the face of the agency's action.
[7] We conclude that where an agen-
cy is engaged primarily in an examina-
tion of environmental questions, where
substantive and procedural standards en-
sure full and adequate consideration of
environmental issues, then formal com-
pliance with NEPA id not necessary, but
functional compliance is sufficient. We
are not formulating a broad exemption
from NEPA for all environmental uxen-
cies or even for all environmentally pro-
tective regulatory actions of such agen-
cies. Instead, we delineate a narrow ex-
emption from the literal requirements
for those actions which are undertaken
pursuant to sufficient safeguards so
that the purpose and policies behind
NEPA will necessarily be fulfilled. The
EPA action here meets this standard,
and hence this challenge to the EPA ac-
tion is'rejected.
IV. CONCLUSION
On review of the decision and Order
of the EPA Administrator, we find it to
be supported by substantial evidence
based on the record as a whole. Fur-
thermore, we find that EPA has provided
the functional equivalent of a formal
NEPA report. Therefore, the two chal-
lenges raised concerning the Adminis-
trator's decision to cancel DDT registra-
tions are rejected and the Administra-
tor's action is affirmed.
, OCCUPATIONAL S. ft H. R. COMTT 1257
3d 1:37(1073)
NATIONAL REALTY AND CONSTRUC-
TION COMPANY, INO,
Petitioner,
v.
OCCUPATIONAL SAFETY AND
HEALTH REVIEW COM-
MISSION, Respondent,
Secretary of Labor, Party Respondent.
No. 72-1978.
United States Court of Appeals,
District of Columbia Circuit
Argued:.CteO4,-..1973. ;>
Proceeding on petition for review of
order of the Occupational Safety and
Health Review Commission which found
that employer committed a serious viola-
tion of the general duty clause of the
Occupational Safety and Health Act.
The Court of Appeals, J. Skelly Wright,
Circuit Judge, held that in absence of
showing of the particular steps employer
should have taken to avoid citation for
permitting employee to stand as a pas-
senger on running board of front-end
loader-at construction site, and the fea-
sibility and likely utility of those mea-
sures, finding of violation was not sup-
ported by substantial evidence.
Reversed. •<
1. Labor Relations O27
Labor Secretary's burden of proving
violations of the general duty clause of
the Occupational Safety and Health Act
includes burden of persuading the com-
mission, or its hearing examiner, by a
preponderance of the evidence. Occupa-
tional Safety and Health Act of 1970, §
5(a)(l), 29 U.S.C.A. § 654(a)(l).
2. Labor Relations O27
Reviewing court must uphold Occu-
pational Safety and Health Review Com-
mission finding of violation of general
duty clause of Occupational Safety and
Health Act supported by substantial evi-
-------
91
APPENDIX C
-------
.2 Standard Apreefnsnt a.-. s?6 out in
Sufcpart C sSiall. by a letter add-esscd to
Fiscal Assistant Sucretarv. Depart-
; of the Trewarv. U'ashl^aSoss. D.C.
20221. slirned by an -ippropriale city et-
Blal."state its agr^sneat to be bauad by
U of the grevlaisns c? the StascSr.?S
ieesent ?e6 fosth below. Copies of
applicable e5ty ordinances, regula-
irif.n:celoas. and forass al\&ll be
,jed. The letter stall als-o state the
aad address of the cfdslail 'Sfho.-a
-».»>-j;^ say eoataefe te sbt'ita
°a::d° other Information seeessary
w uuplsm jnt withholding.
Setter frorej the city official. Ebie Flac_a!
FeefieduB-pa for the wlihfsolrflng.
^he fUlng ef returns, and the payment of
tors to LhG eUy slnll conform to
ascf.l praeciees of agencies.
fdJ Pederai Form W-2. ""Wage
Tax Stateisenfeo" may be used by agencies
for the repsFtlsg of %-ithbeld teses fee eae
eifcy.
. and rcgulatloas
thereunder, for the use of pesticides con-
taining DDT (14.1-trichlorophenyl eth-
ane) on eottoa to control the tobacco
feud wonn. £?.% als© published on Feb=
yuaey 20. 1975, notice la the Psacaas, REG°
xs?£K (40 FR 6228D of informal publle
hearings with respeet to Lauisiaaa's ap-
plSesSion to be held in Baton Rouse. Lou-
islasis, on February 27-28. 3975 and la
Washlnstoa. D.C.. OH J.larch 3=3. 1975.
The objectt?e ef SPA In holding these
•aMeymal heariais "ims to prm-ide nil in<>
^eyested parties ^rffch sn epportunity ln°
Xorsnally to preseafe their views and to
allow EPA to reaeSi & deter® taatlon as
soon as nrseticafele. As Uicse Informal
heartoss pro&Tessed St became apparent
that the questions raised by the Louisi-
ana application direetly relate to the
prior cancellation determination of ths
AdKiln!3trat3r w5tis respeee go DDT. fol-
low-in:? extensive adjudieatorr h»arincs
and J^r::c:.il review. A/tor the in'-ornxal
he.nnn-.? were sr.nouneed. concern do-
%relop'?S T.-lthln SPA thnt because of
these p:-ior administrative tind judict.ii
proceed'. r.ss. lTifonr.il hearings nlcn?
may naS. Hulls' satisfy the requirements
of 'tbe FIFRA. the' AdwinlsfcnUve Fro^
ecdures Ace end due process. EPA
eoncluded shae the -law requires that
pr&gedufes fes- Jsastituted. fo?
-------
BUU
Louisiana, application and for similar
cases in the future, in order to provide
required r.nice and opportunity for
formal puohc hearings to all a:fcc:cd
parties. U the procedures were not re-
vised and the ultimate determir.atlca
were to grant the petition, co-.irt chal^
tenses to the procedures wo';M cz~ f
additional d.'luys and may «vt:i rr. uU
In reversal on procedural i;rot:i:i!«. l:\
such K situation. Louisiana would be
denied the Lcv.eflts or a f.ivor;it:!-; niU:vr
for spring cu'.Uin planting b-?r.u:::e of
procedural Irrc.ulrirHlcs. Tito li.irja. c of
thL-. notice Is to set forth the rvnired
procedures and to explain- ro:; or.s 8ur
requiring r.urij pr-Kfdures. V/lth rr ir-.-ct
to the LoMl.'.lana application this ::o'.!ce
also serves to confirm a tentative t'.zr.e
schedule announced afc the Wa.ihl::^ton.
D.C. informal hearings on March 5. 1075.
within ^hich thase procedures will
The application filed by Louisiana ia=
voivcs the requested use of DDT OB
eot:.?ro. The extensive administrative and
judicial proceedings leadln? up to final
ca-crllation o(? DDT reslstratioos 006
or.iv relate directly to the Louisiana
p-.-utinn but ubo demonstrttte the ex-
h.iu '.Jvc procceUines vhich precede Anal
EPA iti-tiotu In co::trated camvllatlon op
sv-pcn; Ion procecdinas.
Siace She respiration of DOT for
pests oa eotfon. including the tobacco
bud worm, constituted ae least T5r;. of
DOT usage subject to the cancellation
orde? of the Administrator of June 24,
2972 (37 PR 13369) and amounted to 10
ElJlloa sounds of DDT annually. the
Louisiana application for use of 2.25
aalllloE pounds in Louisiana 8s 1973
squarely presents the question of r,-hstl:?r
fehe finaJ cancellation ordes? should be
reconsidered. EPA has defcerraliud thit
any application under section 3 or sec-
tion 13 of FIF32A for the use of a pesti-
cide at a. site and on £ pesfe for which
registration has lieen finally cancelled
ar suspended by thre Adrainlstret/jr Is Ira
substance E petition for reconsideration
of such order. Kccnuse of the extensive
notice and hearing opportunities man-
zMtod by P1FRA end the Administrative
Procedures Act before a final cnr.cctla-
tion or suspension order may be i53';cd.
EPA has detennlr.ed that such orders
icr.y not be reversed or modified dthcufe
affording interested parties — who may
to faefe have participated in lengthy
cancellation proceedings — similar notice
and hearing opportunities.
Section 6 o£ FXFRA permits the Ad-
njisljtrator to issue notice of intent to
cancel a pesticide registration upon a
Sr.dirs by him that the pesticide "£en-
eril'7 causes unreasonable adverse cC-
fccti oa the emiror.ar.ent. "Such notice
Is r^xr-iired to be sent to the registrant
and made public. The registrant. or
ether person adversely affected. rr.;».y
th:n r^ucst a hcnrir.s. The fir.aJ «2e=
c ion of the Ad.t:ini»trafor Is required
to fcs sr.Ads after ths cor.clu^ion of the
hc;'.rl=». The United States Court of Ap-
p^iJj for the Diftrlct of Colunibi.i r..is
c^-;-.vxtcrt:ed tl:e eajicelUUon prcve-
du: - .* iv. rrovicMng "cxtor.sive safcsun rds"
sr.d "ei.iboratc procedural protection"
to psstlctdo rcsl-ij rants end others and.
as a result, "a subvt.int'.a! time, likely to
excr:d one year, ruay lapse between Js=
su.:r.ce of notice of cancellation and r.r.al
f- of e?.r.cell.iti^!i.. c ° °" Er.viron-
?x!cl Dtlfp-** Fund. fr.e. >?. Enctrcri~
:r.tal Prottt'.ton Ag?r.cy. 32S P..2J 373.
Nusaepeuo ccieatlSe o^udie/J and
to go7e?naea8 ogenou-s b.-\va c<
thflt DDT tea o wide >psctrura
a^ecia ca noa target plaa: and a
spsc'.es; it WCFGOSOO tho Ineldi-nco
ol cancer onfi reproductive Ccrec
and Iw Fualducra px?rolo8 In tho en7lronni«
aci3 In tha human Body lont; enough to
found f_u> in time? onU opoco (mm tt)c cngii
^S R2(S Ql 1030-57.
TO THE
co^tJiisoM OP DDT
1 1 1 The snF Petition ol Octaber
O:\ O'tnbi-r 31. !9»i9. tne Environmental
8> .'• r. -c I-'ur.il. The NiUionaJ Audubon
S> ifty. tli«? Sierra. Club and the Wesfc
?.::c!ii :;\n Environmental Actiora Coun°
51-1 r-KDP") flled a petition with the
Secretary of Agriculture rusDA"). re=
qurr-tir.s him «1) to issue notices of can=
cc!!at!on fop all pesticide products eon=
taini-." DDT. and (2) to suspend the
reeistratlons during the eancellatiOB
proceedinea. EDFs petition preclp: ated.
as tJ'.e Admlr^trator's Order natad,
"approslmatcly 3 years of inteasi-re sd=
Kiinssirur'.vc in yfte Secretary of
Response. In- response to EDP's peti=
tion. tliree things occarred. First. U3DA
cancelled four uses of DDT (oa shade
triers, tobacco, around the homo and in
aquatic areas) : second. USDA requested
coirur.ents on other DDT products: and
third. USDA took no action on the re°
quest fop suspension.
On November 25, 2969. TJSDA pub=
li-hcd a notice wfeicfe stated «34 PR
1382?) :
The depafSmoQt; ts eoaaldeFlag earace!!a=
;Uiu ot any other uses of DO? unjess IS COB
Uo shotrc. that esrcato uses ore essential La
C-.a pfotcetloa of aumaa iaeaisfe aad tTeUaro
e,r.d o:.ty thoso oses fo? whlcb there are ao
e.-?e.*;ive aafi safe cubstieuees for tijo ta°
On December 21, 198S, s reply to the
petition was senfc to EOF by the Director
of Science and Education for U3DA. stat°
ing Uvit the Department had been "con=
eemcd for some time over the potential
hazards that may resulfe from the pres-
er.ce of DDT and other persistent pesti=
cides in the environment." and listing
several aettons. Including the above can-
cellations. thafe had been taken. No spe-
cific msRtioa was made of £DF's reauesg
for su5p:cnslon,
<3) SnsiranmentG!. Defense Fund,
Inc. v. llardin l DDT 'Hi. On December
29. 3063. ED? filed a petition in the Court
of Appeals for the District of Columbia
seeking review of CSDA's failure to com°
I;:-/ fully wiUt their requests.
On May 23. 1970. in Environmental De°
/••.w Fund. Itie. v. H&din. 133 U.S. App.
DC. 391. 428 F.2d 1003 <)?70». the
Cc;srt held that EOF bad standing to
ch illcnsc the Secretary's determinations
un'lee FIFRA. that a refusal to suspend
a-.vs rcviewAble. and that the inaction
on I he suspension request was ripe for
w. Tills Cojsrfc noted thafe:
aad remanded to the Secretarj".
Elthtfp fop o frooh determination on :
question of 3Uspcrnl.ni, or for A sr.-.lcmont
re.vMtL« fop his aMent hut effi'^tlre refv
b) su>p:<«.):
(6) "DOT Irs takes and streams aos been
a facto? la fish mortality ae<2
(7) \Vhea DOT accumulates IB "rietfifos
food some hirm may bo doao to
He concluded (p. 8) that:
(S) DOT is set aa "Lrmnlneufc hozani te
human tcslt6~:
|3) -U-.ere ore some adverse effects upcn
certats ff?°«'.e3 of Hah and larlldl Ife";
(3) "ODT h.io indisputably Important and
benencU! u^es to connection with human
boalth a=d a^rteulturo. and tuere ore col yst
:« substirutcs for ell | emphasis add#d]
(•Si ODT use should be reduced to "uses
ahich arc c.ireaeiaj to Uto publie beoieh aaci
Trclf.ire": and
<5) '.'.u-re should bs "contlnuatlcn of the
review of the possible effects (featb benei';c:.-\l
of DDT."
Xn addition 6© issuing the Secretary's
statement a£ reasoas, USDA tooS other
DO. JWS
-------
,-'>,n rubrrnMerit to the filing of EDV"s
•:'.j.'l p-ti?K>n, Specifically, on February
.'."?.:ay 6 «ind August 18. 1970. in order
' protect man and tlj« environment
.cm the hazardous use. of DDT. notices
of canceUatiorj were Issued covering reg=
k: rations for a number of vegetable.
KT.-.m. fniit. forestry, livestock, nursery
and _ lava uses ol products
(5) Environmental Defense Fund. •$.
Ryc?;e!sl'.a33 (DDT in. Or. January 1,
1971. after reviewing USD.Vs S:atemen»
of Reasons, the Court rerr.ar.ded the case
a second time. EhLs time to the Adminis-
trator of the neTrly-crea:ed Environ-
zaeotal Protection Agency. vi-ho had Just
been given authority for administration
of the FIFRA. £Rairon»ficwtct Defense
v. R-jckelsheus. 112 U.S. App. D.C.
J t'.iut the S
tary's refusal to suspend or cancel nil
registrations of DDT h:ul been predi-
cated on an "incorrect Interpretation of
the controlling statute." WJ t\ 2d at 568.
Noting In particular tint the Secretary
had found that DDT :it Iar?;e dosages
caused cancer In experimental animals
and that DDT was toxic to certain birds.
bees, and fish, the Court stated that 16
^as "plain that he found a substantial
question concerning the safely of DDT."
423 F. 2d at 594-93. When such a Ques-
tion exists, this Court hold, the adaiuUs-
fcrsfive procedure must be "triggered."
Accordingly, the case was remanded to
. Ihe Administrator with instructions to
•ue natices of cancellation with respect
:he remaining uses of DDT.
(C) Tr.e Administrator's Issuance of
.ffotices of Cancellation. On January 15,
1971, the Administrator issued notices of
cancellation with respect to ail remain^
ing resist.-ations of DDT products.
Mora than 50 registrants filed objec=
feSora nr.d a request for a public hearing.
T*7© reslstrr.nts. Mont rose Chssiical
©oaapany and Crop King sought advisory
eomrriltc-e consideration. In addition to
EOl-*. s-vcml other parties intervened in
&w ht-arinsf. namely: U.*5DA. The Na-
tional A.'rricultural Chemicals Associa-
tion (fi'ACA). H. P. C:-.n:ion & Son (a
S>.-laxare food processor, only as to use
of DDT on sweet poppers) and Ell Lilly
& Company, a former registrant of one
DDT product. Montrose and Crop King
^•ere not parties to the public hearing.
(?) The Administrator's March IS,
1571 Refusal to Suspend. In response to
Court orctjr that he reconsider the quos-
MOB of suspsnsion. the Administrator is-
sued n statement of "Reasons Underlying
the Registration Decisions Concerning
yrc^ucts Containing DDT. 2,4,5-T,
Alclria and Dieldrln" on rvF.irch 18. 1971.
U set forth the reasons why the Admin=
8s:rutor deemed suspension of DDT prod-
t.?v. ;ir.nece.:3ary in view of the admin-
t--..-.;tive proceeding then ur.denvay. and
oru-.-uitcJ setieml standards relating to
pe."i:id« Ciiicellaiion and suspension.
mailers. Tr.e Administrator noted that:
•.Is <2-.-:?mi!natloh Is .vtpjiorud by tho
re of liie pres -nt i-:.'c:ts of UDT. DDT-
*t\-\£is-l l>7 vlrtxie of It.i j. it*:u;.il toslctty
;pro:o;:;-..'ii low l;ie!s 01 pxnoi-.iro. Tills
(-•> nuuSe aeufo b^t&c pcrslatcaco, mo°
bttlty. nnd btorn.ii>nini:»tloii of DOT In tho
i-nvironnicnO. Rnrn'tnliiini; t!w> rliara--tpr-
Lsitca. the fouf government conusut?.
(9) SDF s. RzcKelshavs (DDT tm.
STOP returned to Court a third time to
challenge the Administrator's refusal to
suspend. Since tv.e advisory comsaUtes
reix>rt was issued just prior to oral ar$ru=
mcnt. the case was remanded to EPA
£or further consideration of the suspea°
sion Lsue In light of the ad;1sory cora-
mittes findings.
(.10) The Admlnislretor's November I.
1971 Stalrment. Xn a statement riled with
the Court on November I. 1971. the Ad-
ministrator nsatn determined noS to sus-
pend DDT products, la reaching thafe
decision he noted that the ad%lsory com-
mittee had 'found:
DDT spreads from Its cite of application,
and Li carried throu r.oue the global bio-
ophere' (Conciuslca 2. p^je 3;i): and DDT
and Its metabolites porsiss for years In the
enviroaznenfc oad becosie concentrstad la
certain species of 2ih and wildlife, which
suffer either prcser.e o? potential dar.^cf
the?t>frora (Conclusion 3. Bisye 39). .
However, the Administrator concluded,
as the advisory committee had similarly
concluded.
ooo there will be no r.nprcc!aWi> dif-
ference In hazard to the PM'I'.I. v.hc'.iur thu
re-.;: .tratlon of DDT l« ln\-«>«!i.\i»ly s\is-
p:-nc!ed or whether It Li c.ir«-i-:i.vi m the OPAP
fin-irs. It warranted. T'.:ercl>.ro. the hann to
the public from DDT cannot be l>.-«stfaed \>y
Untncdljte suspon-iton «.« orr~»'«S to appro-
priate cancellation* UP"H tlio ofclcrif cont-
plecioa ot the csnccll»t:oa procedures.
SDV 9. Ruckehh&us (DDT IV).
With Uie administrative proceedings in
process, the Court on December ». J071.
denied EDF's sit-pensloQ petition, while
at the same time granting EOF the right
to renew its petition if the administra-
tive proceedings were no6 eespleted by
April 15. X972.
(12) Formel PuWte Hearings.
X972. before a hearJas examiner and
(Eoneluded OB Mes'eh ig, XS72. Duriag
those eis?ht moaths. 123 ^ritaesses ' te3ti=
Qed. and 3(53 exhibits were introduced
iat© evidence. The DDT isdustry pre°
sented 11 witnesses end introduced SB
exhibits: USDA, ia a duai role as regis-
trant (of two agricultural gssfe quarau=
tine products) and lafesrvenor. preseated
40 witnesses and S4 exhibits: EDF prs=
sented 13 witnesses and introduced S3
exhibits: and the EPA stag presented 4?
witnesses and introduced 132 exhibits,
The remaining ^rttaessea and exhibits
were Inti-edueed by H. P. Canaon and
EU Lilly. The transcHpe of the evidenti-
ary hearing contains more thaa 9.300
pages.
(13) The Examiner's ReeommendeS
Decision. The Hearing EKaminert rec-
ommended decision was issued OB April
25. 2972. Statins that In order to cancel
DDT. he would either have to find thafe
DDT directly causes cancer in man or
makes the "earth ualnhabitable" the
Examiner concluded that the "DDT
products to issue were aofe misbranded
under the FZFRA (? U.S.C. 13Sb(2),
(2) (2) (e)0 (d) sad (g))"; that, as ,a
matter of law. DDT use is not a earcinc-
genie, mutasenie or teratogeisic hazard
to man: and thafe DDT did nofe have a
deleterious effect oa Ssh or wildlile. Rec.
Dee. pp. 32-94.
(14) Orel Argument Before me Ad°
mlnistrator. On Rtoy 16. 19T2. the Ad-
minlstrator persoaaily heard over tliree
hours of oral argument on the exceptions
raised by tbe various parties.
(15) The Administrator's Cancellation
Or&er of June 14. 1971. On June 14. 19?2.
the Administrator issued an ordsr can-
celling alt DDT registrations except those
for public health and agricultural! pest
Quarantine use. The order established
December 31. 1973, as the elective date
of the cancellations.
At the eratsee, he stated tnat he was
"persuaded ° ° ° that the long-range
risks of ecatiauefi use of DDT for use on
cotton and most other erops Is unac°
oeptable aad ou6weis34s aa^ beaeflts."
Order at L,
The Administrator fo'ucd that DDT Is
persistent, highly mobile In the environ-
ment. biomagnifled in food chains. Red
has deleterious effects on beneficial or-
Cinlsms. The bulk of his Opinion and
Findings were concerned with the hnrm=
ful effects resulting from these proper-
ties and as3e?smcm of the asserted bene-
•33 of the w!tnfss63 were wllditfo bi
32 were catomolo;:lsw. 9 were toi!coi:>-:t <
or p!iarfn.to.'!Oirl*t.-«, S were ciiicc-r cxp.-rtsi.
C r.ori» c'.iemi-«i.'. 3 \vcfo medloAl doctor.*. 2
were eci>::oiiiiifs. and @ were
The peaxninlng v,Hnc=i:es represented
euctpllutjo sad
-------
AND KIGULATIONS
fits of the DDT uses In Issue. He fonr.d
that DDT Ls a potential human carcino-
gen and presents a re.il carcinogenic risk
to ir.:in. See Finding at 3.
He also found widespread hazards to
birds, flsh and other animal life caused
by une of DDT, specifically (iuid) :
1. DDT i/Teccs ph7topl.in!:toa species' com-
position and Itie natural balance la aqualic
ecosystem:!.
3. DOT 1s Vrhal to many beneficial agri-
cultural In.rccts.
3. DDT tan have lo:!ir\l nnd sub'.eShil ef-
fccl; on u e!uJ aTifU!: frc.^hsratcr InTerte-
bratr*. IntluC:.-!? arciiropotla and molluscs.
4. DOT 13 toxic to Qsii.
5. DDT can a~ect the reproductive success
ol C.-h.
6. DDT can hnve a raristy of subletls.-.J
physiological and behavioral effects on Esa.
7. Birds can mobilize lethal anjouats o/
ODT residues.
6. OOT can cause thinning of bird e«g~
ohells and thus Impair reproductive success.
He then found minimal benefits be=
cause adequate alternative pest control
measures were available. Finding V-10.
He ultimately concluded that almost all
uses of DDT were not safe, that the risks
of use far outweighed any benefits and
fchat it was therefore misbranded under
F1FT.A.
(16) ED? v. SPA (DDT V). Coahoma
Ch:rr.:cal Company, EDF and other par-
ties f-ji-chi renew of the Admin.vtrator'a
final cancellation order In the Court of
Appeivls. Observing that the order was
Issued "alter A Icnijthy administrative re-
Tlew. . . ." the Cours afllrmeri ri-.e deter-
mination and crdcr of Uic Administ.rat.or.
Enolror.mcn.tal Drftnse Furrl. In*, v. r.n-
Vlronmrr.tftl Protection Arrcnci'. 4S.9 F. 3d
2217, 12-;a (D.C. Cir. 197U). In so doin?
the Court rejected industry argument
ifcat:
ooo tjje Admlcfjtrator'a findings ore
S-jsu/acIer.t in that they ere based to a l2?£e
extent on data wii'.ch dees aoe directly and
E?'tlflca!!7 relate to the use of DDT to cosa-
£•»: the boll we«v!! and the bolltvorm la the
cotton growing areas of tlie Southeast.
The Court went on to find that:
It Is '.rue that much of the evidence tn the
record concerning dangers ol DDT decs cot
epcc".5f.-:!'.r relate to this one area or to tlie
tse on cotton crops. UotveTer. It Is not neces-
sary to hare erldencc on such o specific use
or area In order to bo able to conclude on the
b - :• of substantial cv'.dccTe that the use ot
r.DT In c--'"s""l Is hazardous. The AArr.lnis-
l.-'.'.-v his polnfo-1 to evidence In the rccc.-d
ah-.r, ;.-.- ti.at u.'2 of DDT except In wlniiscu'.e
orc.c-.'.n'!: In M-jhly controlled cirri.irastancr:cr orders
should only be cmntcd r. here there is
subotantlRl ne.w evidence ?.h!ch may ma-
toria!!y affect fehc order. The pro;1i!oos
of FIFRA relating to notice and
opportunity of adversely eCcctcd
to join in formal hearings: are b
drafted to permit maximum par
tlon In the cancellation prccced!:
other FcdcraJ agencies, the SMtes.
try, environmental groups, and p
eitize-ns. With such bru.ul or)porn
to participate In the ort^ln:il pmcec
tho putiilc Interest—nnd the ititerp
the pirtles who participated In .sucl
cccdinr^—rr^ulres that the Issues I
the Aiiir.lnlstratcr not he relit!
without a threshold determination
there b substantial new evidence '
may material*/ affect the prior i
This procedure does not prejudlc.
interests of parties seeking ssodiflc:
51 there la substantial new evidcr.
fonaal hearing "hould be convent
demonstrate the materiality of such
dence. Moreover, ths public Snteres
mands that public agencies not bi
quired to expead • limited resource
reconsideration of faces previously a
dicated. Public resources should EC
committed to reconsider a pr2o? flr.a
dee ualess there is substantial new
dence which may materially afiece :
order.
For the foregoing reasons. EP/
adopting a new Subpcrt D to the P.
of Practice HO CFR Part 164) set
forth the procedures to be followec
£he ease of an application under FIT
sections 3 or 18 which requests use <
Pesticide at a site and on a pest for wl:
registration has besti finally canes:
cr suspended. These revised iproccdi
require that in any such case She Aum
Istrator will Initially determine, on
basis of the application and support.
data, whether there Is substantial n
evidence which may materially ailcct!
prior order and whether such evlder
could not have been discovered by d
diligence on the part of the parties
ths original proceeding. If ife Js deu
mined that there is no such' ertdeni
then the application will be denied. IT
is determined that there Is such evident
then a formal hearing will be conver.
to detenr.ine whether such evidence m.
terially affects the prior order and r
quires Its modification. This determir.:
tion r.-iU be made on the basis of the re;
ord la the hearing and the recommend:
tlor-s of the administrative law judf
presiding over the hearing, tikir.5 In;
account the human and envrroamerr-
risks found by the Administrator In h
prior order and the cumulative Impcc
of post, present, and anticipated uses L
the future. The procedures adopted to
day also provide that la emergency cir
cumstanccs the Administrator may rui'
on the application without convening :
formal hs.irins when he determine-
that: fl) tite application presents a .<::•
u.:t:on l-nvuhing need to use lh.'» ofslicid>:
to prevent r.ti uiucccpto.blc ri-'k to tl)
hu::ian h-.-.inh. or til) fl>h tuid wIMllfo
v:hcn s':cli u.<2 would not po. the time a\-ai!ahlc to avert tho
risk to hunun health or flsh and wildlife
is insu2c!ent to pernUS convening o>
-------
KU'.Li AND
hoaruv.:: ond (1> th-r p-ibl'.c Interest re-
iu:-.*4 ti;e granting of liie requested use
• . jon 0.1 jx»islble.
•.-.jticc of the Adtr-inlstrvor's deter-
j:atioru regarding sub-itauc;al new evi-
dence will bs published in the FEOEBAL
RrGisTEX. as will noUce of findings of
etr.r~ffr.cies which require action 7/ilh-
ou'. !: earing.
ti the case of the petition by the State
of Louisiana It is anticipated that the
Administrator will make his determina-
tion as to whether substantial new evi-
dence exisu oa or about March 14J 1975.
If It Is determined that no substantial
new evidence Is presented then the peti-
tion will be denied. If it is determined
that substantial newi evidence Is pre-
sented then notice of a formal public
hearts Rill be Issued as soon as possible
and It Is anticipated that, depending on
.the date of th? Administrator's deter-
mination, the hearing would commence
on March 21. 1375. and be scheduled for
approximately five days, with the pre-
siding o'Ucer's recommendations due ap-
proximately four to tlvc days after the
hearing and a final determination by the
Admini.trator anticipated to be made
approximately four to five days there-
after. ;%V.lce of the rcvtsc-d procedures
set for.Ii In this publication and of this
tentative :irr.e schedule was given to all
parties Involved In the Informal public
hearings held in Washington. D.C.. on
March 5. 1975. Because of the March 5.
1975 notice to interested parties. Incl'ud-
'ng the State of Louisiana, the publlca-
• rt of this regulation on the eve of the
rr.inistrator's anticipated decision as
., substantial new evidence will not prej-
udice the interests of interested parties
including the State of Louisiana. All In-
terested parties received notice of these
procedures on March 5 and were encour-
aged to -ubirtit an addition?.! brief state-
ment summarizing iviuxt they maintain
to be .".liistantlal new evidence on
March 10. 1975. The Slate of Louisiana,
and c'.hrr Interested parties have sub-
mittc-1 s-i.-'.i statements.
In r»c>..';r;cn. the Louisiana application
T.-JS filed ^r''.er FIFRA section 18 pursu-
ant to - M-.l. Louisiana is required to
clio77 ti:;:i there is a pest outbreak for
which no r.lterr.atlves are available and
which v/lll result In significant economic
or health problems (40 CFR Part 168).
Loui-slar..* i-^.j questioned whether EPA
la rcTr cJrjLr.stosr the substantive stand-
ard !:;• tiiilcli its application T.-111 be eval-
us'.tct.-The procedures set forth In this
rejuliiio.n do not. horrever. change the
suba.intive rules by r.-'nich the Louisiana
application will be measured. The Issues
raised by the Louisiana application
under section 18 were adjudicated and
fuiAllr decided In the 1972 DDT cancel-
lation case. In that case the Adminis-
trator w.'.s required to n:.ike. and auule,
specific findings ar.d conclusions with re-
specr to l!is risks and bineRts associated
vi;h DDT use on cotton. Tlie Adminis-
••tor's findings and conclusions f/ere
n aCErmcd by the Court of Appeals
'.ho District of Columbia. Thus, no
showing urn!- r -in-ti ,n 13 of ft pest out-
break. of u::»vi::.ViilitV ot r.Uerr.atlvos
and of si T.::'v.i:.t e,-i::'.omlc problems
could now be n-.i-!. wirtivat substanliul
ne?r evidence. w. • prrc-.'dures set forth
In thU re;:ulat! •>- <" ;-\'\ the cppllcation
of the general r-.::.» under sectiorj 3
and 18 to s;:c -i!\.: .-.u-.v. Midi sa the Lou-
isiana application. v\:;U.h In substance
rcauest niocif.i-iiU-jn or reversal of a
prior anal or;'..;-r.
Following t:-.c -072 DOT cancellation
order. EPA per:r.-.t;rd It-nlted quantities
of DDT for tcr.-.:>-!r:-.:y u.;e to control the
pea leaf wes-.il \\r. '. (.-.'• tussock moth In
specific area*. In ::-73 and 1974 DDT
was authorUJd for u.-.u for the pea leaf
weevil In Idal-.o ;\r.d Washington. These
authorizatlor.5 c?r.--iJered the available
evidence "In li;!i: of the terms of the
June 1972 . I', iv ,-vsr. the use of DDT
ior the pea ler.f v.e-.*.:l ?vas not cancelled
by the Admir.i:-.r\Mr In his 1972 ordsr
and thus the pc-.x k:-.f r.-fevtl applications
did not in sub-:tar.tc r-jquc-it the use of
a pesticide ou a ^ :••.". and niainst a pest
which was cincci'.-'d by Anal order.
In 1974 DOT -.v:i« authorized for use
on the Douglas-fir rj-^ocSt moth in Ore-
gon. Idaho antl \v.i-Mr.;ton. That de-
cision specifically .-*-.^rcd that: "The use
of DDT for cor.'..--.', cf the tussoc- moth
was not specifically addressed In (the
1972 DDT cancellation) order, but there
Is no present re ;Utr.;tion of DDT for this
purpose." 39 FR 8H77. The u*e of DDT
on the Douglas-fir tu.'sprk moth was not
cancelled by the Administrator in his
1972 order. This use had been registered
in 1947 by the Forest Service, but the
registration was later vmhdrawn without
objection.
To the extent thnt the procedures an-
nounced in this notice may cliifer frcm
prior agency practici M observed in the
pea leaf weevil. tu.-.:.ccV: moth and other
cases. EPA has concluded that such dif-
ferences are nccc^i'atcd for the reasons
set forth In this preamble.
In accordance wi'.h 5 U.S.C. section
553. the procedures set forth In these
regulations shall take effect upon pub-
lication, without notice and public pro-
cedure thereon, because they contain
rules of agency procedure and practico
rhich are not required to be issued as
proposed rulcmaSir." Tor the reasons set
forth in this prc.-.r:-.!:>. EPA finds for
good cause that tlio effective date of
these regulations will r.ot be postponed
for 30 days after puel'.ration bccauss the
currently pending ni".jlicntion by the
State of Louisiana requests n determi-
nation as soon iis possible and EPA has
determined that these procedures should
be implemented immediately so that the
Louisiana applii'-'ti.^ nuxr be processed
In accordance v.ith them.
For the rcnsoiu sft forth herein. Title
40. Part 1C4 of the C.-cIe of F-.-ocral Reg-
ulations is hereby amend-:;! l<:. adding a
n-;w Su'opart D to read as rtillov.-s:
Dated: March 12. 1375.
E.
Administrator.
Suhpart 0—Rul«3 of Pratllc* «ft
llnjor S»ciion» 3 jnii 1.1 la MmMy Ptoleut
Cancollaliaxi or Su*p«nnon Of J«i»
Sec.
161.133 General.
1*1.131 RSVIOTT By Admlnbtntor.
Itjl.lDJ Procedures sovernln*: hexrlnz.
164.133 Emergency watTtr of heMtog.
ACTHOMTT: Sec. 23m) «:id 8 of th» Ted-
eral I.-^ecttclde. Fun-:i-:l(!c. ana Rodenr.tc!il»
Act, M amended by tfte Fed;ril £nvlror.mea-
tal Pesticidd Control Act of 1974 (38 Scat.
007).
Subpart D—Rules of Practice for Applica-
tions Under Sections 2 and IS To Modify
Previous Cancellation or Suspension
Orders
§ 164.130 General.
EPA has determined that any applica-
tion ucder section 3 or section 18 of the
Act to allow use of & pesticide at a site
and on a pest for which registration has
been finally cancelled or suspended by
the Administrator constitutes a petition
for reconsideration of such order. Be-
cause of the extensive notice and hcar-
inj opportunities mandated by FTFHA
and the Administrative Procedures Act
before a final cancellation or suspension
order may be issued. EPA has deter-
mined that such orders may not be re-
versed or modified without aCortir.;
Interested parties—who may In fact have
participated in lensthy cancellation pro-
ceedings—similar notice and hearing op-
portunities. The procedures set forth in
this Subpart D shall govern all such
applications. - *
§164.131 Review Lr Admin utrnJor.
(a) The Administrator will review ap-
plications subject to this Subpart D and
supporting data submitted by the appli-
cant to determine whether reconsidera-
tion of the Administrator's prior cancel-
lation or suspension order Is warranted.
The Administrator shall determine that
such reconsideration is warranted when
he finds that: (1) the applicant has pre-
sented substantial new evidence which
may m.itcriaUy affect the prior cancella-
tion or suspension order and which was
not available to the Administrator at
the time he made his Una] cancellation
or suspension determination and (2>
such evidence could not, through the ex-
ercise of due dlllceace. have been dis-
covered by the parties to the cancellation
or suspension proceeding prior to the is-
suance of the final order.
(b) If alter review of the application
and other supporting data submitted by
the applicant, the Administrator deter-
mines, in accordance with paragraph (a).
of this section, that reconsideration of
his prior order is not warranted, then
the application will be denied without
requirement for an administrative hear-
ing. The Administrator shall publish no-
tire In the FEDCSAI. RECISTF.R of the ds=
nlal briefly describing the basis for Ills
determination as soon as
Such denial shall constitute final
action.
cc) If after review of the npplie.ulon
and other supporting c'.itj. submi'.u-d by
the applicant, the Admail:.trator deter-
-------
< the date
on which the presiding olHccr shall sub- .
mithls recommendations. including 3nd- I
l-iss ol fact and conclusions, &a t.*;e Ad-/
' ailrJsirator. and (4) the date on which
a decision by the Administrator Is antic-
ipated.
§ 264.132
governin
(a) The burden of proof In the hearing
convened pursuant to 116-J.13I shall be-
on tho applicant and he sJwll proceed
'first* The issues in the hearing1 shall be
whether: (I) substantial new evidence
exists and (2) such substantial new evl°
dence requires reversal or modiScatioss
of the existing1 cancellation or suspen-
sion order. The determination of these
L-iues shall be made takin? into account
U:e human and eavlronmental risia
fo^r.d by" the Administrator in his ean=
c-.'ibtioa or suspension determination
and the cumulative effect of r.Il past and
present uses, including the requested use.
and uies which may reasonably be an-
ticipated to occur in the future as a
result of grcntinsr the requested reversal
or modification. The granting of a par-
ticular petition for use may not In itself
pose a significant risk to man or the en-
viror.-nene. but the cumulative impact of
each ecViitlonal use of the cancelled or
stispend^d pes'icsde may re-estnbl;$h. or
£crvv to malp.Uin. the si?nlfica::t rts'xs
pfi'TiousIy found bv the AdmfnSfr.-.tor.
(b) The presiding officer shall raake
r-xosunendaticns, including findings of
f«icS and conclusions and to the extent
feasible, as determined by the presiding
oiicer. the procedures at the hearing
fl-.:ll follow the Rules of Practice, set
fsrth In Subparts A afld B oi this Part
§ lS-f-133 Eines-g'-nej' waives of Iicnring.
(a) In the case of an application sub-
ject to this Subpart D which is filed under
S-*:ti?n 13 of FIFRA, end regulations
ti'c-reisdcr, and for which a hearing
L; K'.".::-:d pursnnnt to J 164.131. the
/.c:r_-.."'.:iwr m^y dispense with the re-
Tlut there fa no other feasible
solution to such risk; nnd
(3) Thnt the time available to aveit
fciie rh-: to hmnajn health or fkh '-'.'.'-I
y!-n?rj is insuScicnt to permit con-
vening E, hearing as r?Qr.lnd by ?
131:end
(4) That the? public Interest requires
4he granting of the requested use as
soon as possible.
.'b> Notice of any determ!p..it!oB
made by the Administrator pursuant te
(a) of this section s|pll be
l:*hed Is, the FtBea.\£, Rsctsrs^ as
as practicable after ^mntirs the
requested use snd shail see forth the
bisLs for the Administrator's deter-
mination
(?RBoe.73-?oaorj!ed3-S7-7S:S:43 omj '
^ ntle 4t —Public Welfare ~=~
CHAPTER JCV—FUND FOR THE IMPROVE"
WENT OF POSTSECONDARr EDUCA-
TION. DEPARTMENT OF HEALTH, ECU-
AND WtLFARE
PART xsoi—supporrr FOK
OF POSTSECOMOASY IQUeATIOiSf
Pursuant »o the authority eor.taiaed la
cuctiori -.33 of the General Education
Provisions Ace (20 U.S.C. 12uld). "Sup-
port for . provemene of postseeondary
education", a sotlce of proposed rule
malting was published la the FEDSSA&
RECJSTZR on December 2. 197-s (Vol. 30.
No. 232) . The amendments to the regula-
tions. reflected In g§ 1501.2-3. 1501^-7.
1501.9-11. would: (a) redefine the special
focus proira.23 objectives and establish
national projects competitions; (b) re-
vise the existing definitions and criteria
for the review and selection of applica-
tions and preapplic&tlons; and (c) In-
corporate appropriate sections of the
OEce of Education's General Provisions
Rcsuir.tlons (45 CFR Part lOOa) and re-
voke some corresponding provisions in
the existing1 regulations. Interested per-
sons were siven thirty (30) days in which
to submit written comments, sussjstioas,
or objections regarding the proposed
amendments.
One response was received which In-
cluded two recommendations: (1) that
the Fund Include examples of projects
that tm-e not been funded In order to
clarify the criteria for selecting pro-
posals: and (2) that the Fur.d aot In-
clude reference to "attitudes and values"
in section 1501.9 under the description of
£fae Special Focus Program, "Education
sad Certification for Competence."
Neither suggestion would appear £o call
for a change in the amend.-nrnts. In re-
sponse to the first recommendation, H
was not considered appropriate to tn=
elude in the FEDERAL RecistEr. examples
of projects which have not been funded.
The Fund's program Is disisned to gen-
erate ideas from the field; no speckle
types of project proposals are foreclosed.
In response to t!:e second rcconirscn-
dation. the mention of "attitudes and
values" as a possible goal specification Is
only sus3cstlve; applican?s nre under r.o
obLs.itlon or requirement to iuciude at-
titudes or values amor.s (he reals in-
cluded in the project pror •:>"»!• 'r- .'.l:o'.i!cl
be noted that the Fund has no spcdf.c
attitude oor value In mind as dc.-irable
Eoai specifications.
Effective date. The notice of \>
pulemaklns was transmitted to C
on December 2. J07-J pursuant to
431 of the General f.Mucntlc
visions Act <2fi 0.S.C. 12J2(a)
period see forth therein ?o
octloa has expired v
sueh action having bien taken.
fore, these criteria shall become e;
on March 18. 197S.
fFed.
(2) Federal financial assistance ur.dej
this part is also subject to the provisions
of ti::e ZX of the Education Amend-
ment? of 1072 (prohibition o( sex dls-
cr::r.:::ation». and any rejulaUons I.-'.sucd
there u^rier.
< M Ccncrel provMona
A.* ' V.-nnee under this pirt J^ subject
to i!i.- provisions set forth in P.irU lOii
nnd ICOa of this title (relating to
PEDEB.U SECIStl^, VOU ^0. MO. S3—TUESDAY. MARCH IS,
-------
98
APPENDIX D
-------
:v-\
(guested 2.25 million pounds of DDT is
accessary because:
1. Average cotton yields have declined
Etfgnfflcsatfe' to 1973-4 compared with
She average cotton, yield for the previous
(10) years when DDT was avail-
353-2]
STATE OF LOUISIANA REQUEST FOR
EMERGENCY USE OF DDT "O
Statement of Reasons for the Order
and Determination of the Administrator
that Reconsideration of the Agency's Pri-
or Order of Cancellation of DDT for Us®
on Cotton Is Not Warranted.
On January 24, 1975. the State of
Louisiana applied to the Environmental
Protection Agency (EPA) for a specific
exemption under section 18 of the Fed-
eral Insecticide, Fungicide, and Rodenti-
cide Act, as amended (FZFRA) for the
application of 2.25 million pounds of DDT
(1,1,1-trlchlorophenyl ethane) to con-
trol the tobacco budworm (.Heliothis m-
rescens F.) on approximately 450.000
acres of cotton. On February 10, 1975,
EPA published notice in the FEDERAL REG-
ISTER (40 FR 6229) of the filing of this
application and notice (40 FR 6228) of
Informal public hearings with respect to
the application to be held in Baton
Rouge, Louisiana, on February 27-28,
1976 and In Washington, D.C., on March
3-5, 1975. On March 14, 1975, I Issued a
brief Order and Determination denying
the Louisiana request and stated that a
more detailed statement would follow
on March 17, 1975. This Statement of
Reasons provides a more detailed espla=
station of the basis for my Ordep.
I. The Application. The application
fried by Louisiana states
2. in 1974, Louisiana experienced Its
worst tobacco budworm. infestation in
Mstey ant ihe budworm Is anticipated
to be a major problem in 1975;
3. Tobacco budwoTn populations ex-
hiblS resistance to must of the alternative
ragSstered pesticides which are either in-
effective, phytotoslc or unavailable in
sufficient quantities and no other alter-
aative means of control are available;
•£. Serious economic Injuries will re-
sult to cotton farmers and supportive in-
dustries from the tobacco budworm if
DP'" Is not "la'-f.c available; and
5. Rsstricwons on tiie method and
'timing of snolicatlon will pnsvat ad-
verse envlrou Cental effects.
3DL Background. The background of
•She Louisiana application and the use
£ DDT on cotton has been set forth la
Retell in the preamble to the regula-
tions promulgated by EPA on March 12,
2975, establishing a new Subpart D of
t&® Rules of Practice for Applications
BMes- sections 3 and 18 to Modify Previ-
ous Cancellation or Suspension Orders.
However, because of the importance to
(Ms case of the background information
sefe forth in that document, I feel com-
pelled to refer to that information in this
The purpose of the February 27-28
March 3-5 informal public hearings
oa the Louisiana application was to pro-
vide all interested parties with an op-
portunity informally to present their
views and to provide EPA with informa-
tion necessary in order to reach a deter-
mination as soon as practicable. As these
informal hearings progressed it became
apparent that the questions raised by
the Louisiana application directly re-
lated to the- prior anal order of the Ad-
ministrator cancelling virtually all reg-
istered uses of DDT, including use on
cotton, following extensive adjudicatory
hearings and judicial review.1 Because
of these prior administrative and judi-
cial proceedings, concern developed with-
in EPA shortly after the announcement
of the 'informal hearings that revised
procedures may be required in order to
satisfy the requirements of the FZFRA,
She Administrative Procedure Act (APA)
and due process. Following an analysis
of the question, EPA concluded that the
Xaw and the public interest required that
such revised procedures be instituted for
the Louisiana application and for simi-
lar cases in the future, in order to pro-
vide required notice and opportunity for
formal public hearings to all affected
parties where substantial new evidence
Js presented which may materially affect
a prior final order.
rhe registration.of DDT for pests on
cotton. Including the tobacco budworm,
constituted approximately 86 percent 'of
the almost 12 million pounds of DDT
used in the U.S. prior to the cancellation
order of the Administrator of June 14,
1972 (37 FR 13369) (hereinafter the
"1972 Order"), At that time DDT use on
cotton amounted to approximately 10.3
million pounds annually. The Louisiana
application seeks the use of 2.25 million
pounds in Louisiana this year, which
amounts to approximately 19 percent of
the total annual quantity of DDT used
In the U.S. prior to cancellation and ap-
proximately 22 percent of the total an-
nual quantity of DDT used on cotton in
the T7.S. prior to cancellation. Accord-
ingly, the Louisiana application squarely
presents the question of whether the
final cancellation order should be re-
considered.
EPA has determined that any applica-
tion wider section 3 or section 18 of
F1KRA for the use of a pesticide at a site
and on a pest for which registration has
been finally cancelled or suspended by
the Administrator Is In substance a peti-
tion for reconsideration of such order.
Certainly, the Louisiana application,
which requests relatively large quantities
of DDT for a use which was the primary
use prior to cancellation, Is In substance
a request for "such reconsideration. Be-
cause of the extensive notice and hearing
opportunities mandated by FIFRA and
the APA before a final cancellation or
suspension order may be issued, EPA
has determined that such orders may
not be reversed or modified withbut af-
fording interested parties—who may in
fact have participated in lengthy can-'
cellation proceedings—similar notice and
hearing opportunities where substantial
new evidence exists which warrants
such reconsideration.
Section 6 of FIFRA permits the Ad-
ministrator to issue notice of intent to
cancel a pesticide registration upon a
anding by him that the pesticide "gen-
erally causes unreasonable adverse
effects on the environment." Such no-
tice is required to be sent to the registrant
and made public. The registrant, or other
person adversely affected, may-then re-
quest a hearing. The final decision of the
Administrator is required to be made
after the conclusion of the hearing. The
United States Court of Appeals for the
District of Columbia has characterized
the cancellation procedures as providing
"extensive safeguards" and "elaborate
•procedural protection" to pesticide regis-
trants and others and, as a result, "a
substantial time, likely to exceed one
year, may lapse between issuance of no-
tice of cancellation and final order of
cancellation. ° ° "" Environmental De-
fense Fund, Inc. v. Environmental Pro-
tection Agency. 328 F. 2d 528. 533 (1972).
JUso of DDT by public health officials In
(SissaBO control programs and by othe? civil*
Scsi onfi milltoFy officials £or heoltia quar&n<»
not cancelled.
o Tbo National Cotton Council of America
contended that DDT usa on cotton accounted
for 99 percent of the total use immediately
prlo? to the 1973 Order because of the prior
cancellation of certain minor uses.
DE61STSB, VOL-46. NO. 68—TU6S9AV, AP8I8. 0, WS
-------
The application filed by Louisiana In-
volves the requested use of DDT on cot-
ton. The extensive administrative and
judicial proceedings leading up to final
cancellation of DDT registrations not
only relate directly to the Louisiana peti-
tion but also demonstrate the exhaustive
proceedings which precede final EPA ac-
tions in contested cancellation or suspen-
sion proceedings.
A. Proceedings Leading to the Final
Cancellation of DDT.
(1) The EDP Petition of October 1969.
On October 31. 1969. the Environmental
Defense Fund. The National Audubon
Society, the Sierra Club and the West
Michigan Environmental Action Counsel
(EOF) filed a petition with the Secretary
of Agriculture CUSDA), requesting him
(1) to issue notices of cancellation for
all pesticide products containing DDT,
and (2) to suspend the registrations dur-
ing the cancellation proceedings. EDF*s
petition precipitated, as the Administra-
tor's 1972 Order noted, "approximately 3
years of intensive administrative inquiry
into the uses of DDT." 1972 Order. 37
FR at 13369.
(2) The Secretary of Agriculture's
Response. In response to KDF*s petition,
three things occurred. First, tJSDA can-
celled four uses of DDT (on shade trees,
tobacco, around the home and In aquatic
areas); second, USDA requested com-
ments on other DDT products; and
third. USDA took no action on the re-
quest for suspension.
On November 25, 1969, USDA pub-
lished a notice which stated (34 FB
18827):
Tie department Is considering cancella-
tion of any other uses of DOT unless it can
be shown that certain uses are essential In
the protection of human health and, welfare
and only those uses for which there are no
effective and safe substitutes for the In-
tended us* will be continued.
On December 11, 1969, a reply to the
petition was sent to EDF by the Director
of Science and Education for USDA, stat-
ing that the department had been "con-
cerned for some time over the potential
hazards that may result from the pres-
ence of DDT and other persistent
pesticides in the environment," and list-
Ing several actions, including the above
cancellations, that had been taken. No
specific mention was made of EDF*s re-
quest for suspension.
(3) Environmental Defense Fund, Inc.
v. Hardin (DDT /). On December 29.
1969, EDF filed a petition in the Court of
Appeals for the District of Columbia
seeking review of USDA's failure to com-
ply fully with their requests.
On May 28, 1970, In Environmental
Defense Fund, Inc. v. Hardin. 428 F. 2d
1093 (1970), the Court held that EDF
had standing to challenge the Secretary's
determinations under FIFRA, that a re-
fusal to suspend was renewable, and
that the Inaction on the suspension re-
quest was ripe for review. This Court
noted that:
numerous scientific studies and several
reports to government agencies have con-
cluded that DOT has a wide spectrum of
NOTICES
harmful effect* on nontarget plant and ani-
mal species; it Increases the incidonc* in
>nim.iii Of cancer and reproductive defects;
and Its residues persist in the environment
and In the human body long enough to be
found far in time and space from the original
application. 438 F. 2d at 1094-47.
The Court remanded to the Secretary:
either for a- fresh determination on the
question of suspension, or for a statement
of reasons for his silent but effective re-
fusal to suspend the registration of DDT. If
he persists in denying suspension In the face
of the Impressive evidence presented by peti-
tioners, then the basis for that decision
should appear clearly on the record, not In
conclusory terms but In sufficient detail to
permit prompt and effective review. 438 F.
2d at 1100.
In addition, the Court ordered USDA to
decide "on the record" whether to issue
the remaining, requested' cancellation
notices or to explain the reasons for de-
ferring the decision still further. Ibid.
(4) The "Statement of Reasons" of the
Secretary and Additional Cancellations.
On June 29, 1970, the Secretary filed a
"Statement of Reasons Underlying the
Decisions on Behalf of the Secretary with
Respect to the Registrations of Products
Containing DDT." At the outset he ad-
hered to "the prior determination that
no DDT registrations should be sus-
pended at this time, and that further
action with respect to cancellations
should await completion of [USDA's
intra-agency] use-by-use evaluations
presently in progress." Statement of
Reasons at 1. He went on to make the
following findings:
• (1) that there are reports of carcinogen -
Iclty resulting from the administration of
large doses of DDT In test animals (p. 1);
(3) DDT ia persistent and accumulates In
qnlrnn.1 tlSSUeS (p. 3) I
(3) DDT is present In most forms of -ani-
mal life (Ibid.);
(4) then Is Information which suggests
that DDT Is Interfering with the reproduc-
tion of 'certain raptorial birds and may be a
contributor, among other factors, to the de-
cline of some of these species (ibid.);
(5) DDT is moderately toxic to honey bees
(Ibid.);
(6) DDT In lakes and streams has been a
factor In fish mortality and reproductive fail-
ures (ibid.); and '
(7) When DDT* accumulates In detritus
food some harm may be done to detritus feed-
ers (pp. 3-4).
He concluded (p. 8) that:
(1) DOT is not an Imminent hazard to hu-
man health;
(3) there ere some adverse effects upon
certain species of fish and wildlife;
(3) DDT has Indisputably important and
beneficial uses in connection with human
health and agriculture, and there are not
yet available substitutes for all essential uses:
(4) DDT use should b» reduced to "uses
which are essential to the public health and
welfare"; and.
(8) there would be continuation of the
review of the possible effects (both beneficial
and deleterious) of DDT.
In addition to Issuing the Secretary's
statement of reasons, USDA took other
action subsequent to the filing of EDF*8
Initial petition. Specifically, on Febru-
ary 26, May 6 and August 18.1970, in or-
der to protect man and the environment
from the hazardous use of DDT. notices
of cancellation were issued covering reg-
istrations for a number of vegetable,
grain, fruit, forestry, livestock, nursery
and lawn uses of products containing
DDT.
(5) Environmental Defense Fund v.
Ruckelshaus (DDT II). On January 7.
1971, after reviewing USDA's Statement
of Reasons, the Court remanded the case
a second time, this time to the Admin-
istrator of the newly-created Environ-
mental Protection Agency, who had just
been given authority for administration
of FIFRA. Environmental Defense Fund
V. Ruckelshaus, 439 F. 2d 584 (1971).
The Court determined that the Secre-
tary's refusal to suspend or cancel all
registrations of DDT had been predi-
cated on an "incorrect interpretation of
the controlling statute." 439 F. 2d at 588.
Noting in particular that the Secretary
had found that DDT at large dosages
caused cancer in experimental nnimaia
and that DDT was toxic to certain birds,
bees, and fish, the Court stated that it
Was "plain that he found a substantial
question concerning the safety of DDT."
439 F. 2d at 594-95. When such a ques-
tion exists, the Court held, the adminis-
trative procedure must be "triggered."
Although benefits may be balanced
against risks, the Court held that such
balancing must occur "in the full light
of a public hearing • • • [and] greater
weight should be accorded the value of
a pesticide for the control of disease,
and less weight should be accorded Its
value for the protection of a commercial
crop." 439 F. 2d at 594 (emphasis added).
Accordingly, the DDT case was remand-
ed to the Administrator with instructions
to Issue notices of cancellation with re-
spect to the remaining uses of DDT.
(6) The Administrator's Issuance of
Notices of Cancellation. In compliance
with the Court's order In DDT II, on
January 15. 1971. the Administrator is-
sued notices of cancellation with respect
to all remaining registrations of DDT
products.
More than 50 registrants filed objec-
tions and a request for a public heating.
Two registrants, Montrose Chemical
Company and Crop King sought advisory
committee consideration. In addition to
EDF, several other parties intervened in
the hearing, namely: USDA, The Na-
tional Agricultural Chemicals Associa-
tion (NACA), H. P. Cannon & Son (a
Delaware food processor, only as to use
of DDT on sweet peppers) and Ell Lilly
It Company, a former registrant of one
DDT product. Montrose and Crop King
were not parties to the public hearing.
(7) The Administrator's March 18,
1971 Refusal to Suspend..In response to
Court Order in tiDT II that he reconsider
the question of suspension, the Adminis-
trator Issued a statement of "Reasons
Underlying the Registration Decisions
Concerning Products Containing .DDT,
2,4,5-T, Aldrin and Dieldrin" on March,
18.1971. It set forth the reasons why the
Administrator deemed suspension of DDT
FEDEHAt REGISTER VOL 40, NO. ««—TUESDAY, APtlt 8, 1975
-------
101
products unnecessary In view of the ad-
ministrative proceeding then imderway,
and articulated generaS standards relafc°
ins to pesticide cancellation end susper -
aion matters. The Administrator noted-
thsfc:
This determlnattoa in supported by the no-
euro of the presant oSecto c2 DOT. DDT Is o.
hcz&n& by virtue of Its patentl&l tOKlclty E&
prolonged low levelo o£ exposure. This hazard
la made acuto by tho persistence, mobility,
and btomagnlflcstlon of DDT In tho environ-
ment. Recognizing these characteristics, tho
four government committees which have
studied the DOT problem In depth bstwaon
1883 and 1969 have all recommended .that its
uso bo phased out over £> period of tlmo.
[Footnote omitted] None he.ve recommended
on Immedlato ban. However, ths time has
como for resolution of the DDT Issue ID light
of the standards set out In the ETFRA. This
Is now being done through tho orderly aS-
mlnlstrotlvo forum provided by tno statute
In tho cancellation proceedings.
(8) Advisory Committee Report The
advisory committee requested by Crop
King and Montrose. and composed of ex-
parts nominated by the National Acad-
emy of Sciences, began deliberations
on DDT 8n May, 1971. On September 9,
1971, the committee issued its report and
recommendations. After s leagihy. dis-
cussion of the" scientific evidence of the
hazards of DDT us®, the committee
found that DDT posed an imminent h&z-
ard to the environmental and recom-
mended that all DDT uses be rapidly
phased out. Previously, four Presidential
and other scientific commissions recog-
nized the inherent hazards of DDT. "Use
of Pesticides." A Report of the Presi-
dent's Science Advisory Committee
(May. 1963); "Restoring the Quality of
Our Environment," Report of 4he En-
vironmental Pollution Panel, President's
Science Advisory Committee (November,
1965); Report of the Committee on Per-
sistent Pesticides, Division of Biology
and Agriculture, National Research
Council, to U.S. Department of Agricul-
ture (May, 1963); the Report of the
(H.E.W.) Secretary's Commission on
Pesticides and Their Relationship to
Environmental Health (Mrak Commis-
sion) (December, 1969).
(9) EDF v. Ritckelshaus (.DDT III).
EDF returned to Court a third time to
challenge the Administrator's refusal to
suspend DDT registrations. Since the ad-
visory committee report was Issued Just
prior to oral argument, the case was re-
manded' to KPA for further considera-
tion of the suspension issue In light of
the advisory committee findings.
(10) The Administrator's November 1,
1971 Statement. In a statement filed with
the Court on November J, 1971, the Ad-
ministrator again determined not to sus-
pend DDT registrations. Xn reaching
that decision he noted that the advisory
committee had found:
DDT spreads from Its alto of application
and la carried "throughout the global blc-
ophere" (Conclusion 2, page 39); end DDT
and Its metabolites persist for years In the
environment and become concentrated in
certain species of fish and wlldllfQ, w&leh
ouSer either present or potential danger
therefrom (Conclusion 3, page 36).
However, the Administrator concluded,
as the advisory committee had similarly
concluded,
000 fcaero will ba no appreciable differ-
ence In hazard to the public whether tbo
registration of DDT la Immediately sus-
jssnJeS or whether It Is cancelled In tho
noes' future. If warranted. Therefore, the
harm to the public from DDT cannot be les-
sened by immediate suspension as opposed
to approprtata cancellations upon the or-
tiorly completion of the cancellation proce-
dures.
(11) SDF v. Rucxelshaus (.DDT JV).
With the administrative proceedings in
process, the Court on December 9, 1971,
denied EDF's suspension petition, while
at the same time granting EDF the right
to renew its petition if the administra-
Qve proceedings were not completed by
April 15.1972.
f'S) Formal ^ubllc Hearings. Formal
public hea—_gs commerced on August 17,
1971, before a hearing examiner P id con-
cluded on a. ?h 16, 1972. During those
eight months, 123 witnesses" testified,
and 363 exhibits were introduced into
evidence. The DDT industry presented 17
witnesses and introduced 58 exhibits
TJSDA, ia e, dual role as registrant (of two
agricultural pest quarantine products)
sad interveaor, -presented 40 witnesses
and 94 exhibits; EDP presented 13 wit-
nesses and introduced 66 exhibits; and
the EPA staff presented 47 witnesses and
introduced 132 exhibits. The remaining
witnesses and exhibits were introduced
by H. P. Cannon and Eli Lilly. The tran-
script of the evidentiary hearing contains
more than 9.300 pages.
(13) The Examiner's Recommended
Decision. The Hearing Examiner's rec-
ommended decision was issued on April
25, 1372. Stating that in order to cancel
DDT, he would either have to flnd that
DDT directly causes cancer in man or
makes the "earth uninhabitable,"' the
Examiner concluded that the "DDT
products in issue were not misbranded
unties- the FTFRA (7 U.S.C. 135b(2), (z)
(2) (c), (d) and (g))"; that, as a matter
of law, DDT use is not a carcinogenic,
mutagenic or teratogenlc hazard to man,
aad that DDT did not have a deleterious
effect on flsh or wildlife. Recommended
Decision at 92-94.
(14) Oral Argument Before the Ad-
ministrator. After receiving extensive
written briefs, on May 16, 1972, the Ad-
ministrator personally heard over three
hours of oral argument on the exceptions
raised by the various parties.
(15) The Administrator's Cancellation
Order of June 14,1972. On June 14,1972.
the Administrator issued an order can-
celling all DDT registrations except those
for public health and agricultural pest
Quarantine use. The order established
December 31, 1972. as the eSective date
of the cancellations.
0 38 of the wltnessss wera wildlife biologists,
33 were entomologists, 8 were toxicologlsts or
pharmacologists, & wsro cancer experts, 8
wera chemlsto, 6 were modlcd doctors, 3 wore
economists, and 6 wero businessmen. The re-
maining trttnessM represented other miscel-
laneous disciplines and fields.
At the outset, he stated that he was
"persuaded ... that the long-range risks
of continued use of DDT for use on cot-
ton and most other crops is unacceptable
and outweighs any benefits." 1972 Order,
37, PR 13369.
The Administrator found that "once
dispersed, DDT is an uncontrollable, dur-
able chemical that persists in the aquatic
and terrestrial environments." 1972 Or-
der, 37 FR 13370. He concluded that DDT
was "highly volatile" <37 FR 13370 n. 16)
and "can vaporize from crops' and soils'*
(37 PR at 13373); that it "can be trans-
ported bv drift during aerial application"
(Id. at n. A, 3 (a)); and that it "can be
attached to eroding soil particles" (Id.
at n. A, 3(c)). The Administrator
also found that DDT "can persist in the
soils for rears and even decades" (Id.
at n. A, 1); that ft "can persist In aquatic
ecosystems" (Id. at H, A, 2); and that
"it is occasionally found in remote areas
or in ocean species, such as whales, far
from any known area of application" (37
FR at 13370-71). As a result of its per-
sistence and mobility, the Administrator
found that DDT is "concentrated in or-
ganisms and transferred through food
webs" (37 FR at 13375); that DDT "ac-
cumulation in the food chain and crop
residues results in human exposure" (Id.
at HI, A. 2): and that "human beings
store DDT" in their tissues (Id. at m,
A, 3).
With re-p:-t to h-iman health, the Ad-
ministrate found th-»t "DDT causes tu-
mors in laboratory animals" (Id. at IV.
A. 9t "there is some indication
of metastasis" of such tumors (Id. at
IV, A. 9(b»; thst "tumor induction in
mice is a valid wpmlng of possible car-
cinogenic properties" (Id. at IV, A, 9
(c)); that there are "no adequate nega-
tive experimental 5-tucUes in other mam-
malian species" and "no adequate human,
epidemiolo'ical data" (Id. at IV, A, 9 (d-
e)); and that "not all chemicals show
the same [labor-tory) tumorigenic prop-
erties" (Id. at IV. A. 9(f)). Accordingly,
the Administrator found that DDT poses
a cancer risk to man. (Id. at IV, A, 9;
IV, B).
The Administrator also found that
DDT poses hazards to birds, flsh and
other animal life:
I. DDT affects phytoplankton species' com-
position and the natural balance In aquatic
ecosystems.
2. DDT Is lethal to many beneficial agri-
cultural Injects.
3. DDT can have lethal and sublethal ef-
fecta on useful aquatic freshwater Inverte-
brates. Including arthropods and molltisks.
4. DDT Is to»lc to ft°h.
6. DDT can aTect the reproductive success
of fl?h.
3. DDT can have a variety of sublethal
physiological and behavioral affects on fish.
7. Birds can mobilize lethal amounts of
DDT residues.
B. DDT can cause thinnings of bird egg-
ohalls end thus Impair reproductive success.
(Id. at,IV. A. 1-8).
Concerning DDTs benefits, the Ad-
ministrator found that "DDT is useful
for the control of certain cotton insect
pests" (Id. at V,A. 1); that "cotton pests
are becommJns resistant to DDT" (Id at
FSDEKAl BEGISTE8, VOL 40, NO. 68—TUESDAY, APBIl 8. 197"
-------
V.A. 2); and that "by using methyl para-
thion or other means of pest control cot-
ton producers can generally produce
satisfactory yields at acceptable cost"
(Id. at V.A.4). With respect to alterna-
tive chemical pesticides, the Administra-
tor found that "methyl parathlon and
other organophosphata chemicals are
effective for the control of cotton pests";
that they are "less toxic to aquatic life
than DDT"; that they "appear to be
less 'persistent' and do not build up in
the food chain"; and that "methyl para-
thlon Is acutely toxic by dermal, respira-
tory exposure and oral inhalation" (Id
at V.A, 3). The Administrator concluded
that "the use of DDT was not necessary
for the production" of cotton and other
specified crops. (Id. at V.B).
(16) EOF v. EPA (.DDT V). Coahoma
Chemical Company, EDF and other
parties sought review of the Administra-
tor's final cancellation order in the Court
of Appeals. Observing that the order was
Issued "after a lengthy administrative
review" and on the basis of "an extra-
ordinarily voluminous record" the Court
found that the 1972 Order was sup-
ported by substantial evidence and af-
firmed. Environmental Defense Fund,
Inc. v. Environmental Protection Agency,
489 F. 2d 1247. 1249, 1251, 1254 (D.C. Clr.
1973). In so doing the Court rejected in-
dustry argument that:
• • • the Administrator's findings are In-
sufficient In that they are based to a large
extent on data which does not directly and
specifically relate to the use of DDT to com-
bat the boll weevil and the bollworm In the
cotton growing areas of the Southeast.
The court went on to find that:
It is true that much of the evidence'in
the record concerning dangers of DDT does
not specifically relate to this one area or to
the use on cotton crops. However, It la not
necessary to have evidence on such a specific
use or area In order to be able to conclude
on the basis of substantial evidence that
the use of DDT in general Is hazardous. The
Administrator has pointed to evidence in the
record showing that use of DDT except in
minuscule amounts in highly controlled cir-
cumstances should be curtailed because of
unreasonable risks to health and the en-
vironment. Reliance on general data, con-
sideration of laboratory experiments on ani-
mals, etc., provide a sufficient basis to sup-
port the Administrator's findings, even with
regard to each special use of DDT. 489 F. 3d
at 1353-64 (footnotes omitted).
B. The Required Procedures. In can-
cellation and suspension cases where
EPA has finally determined to cancel or
suspend a pesticide registration after ex-
haustive notice and opportunities for
hearing as mandated by FIFRA and the
APA, fairness requires that such final
orders not be modified or reversed
lightly.' Such prior orders should not be
modified or reversed without notice and
opportunity for formal public hearings.
• In addition to DDT, In each of the other
major cancellation and suspension proceed-
ings Initiated pursuant to FIFRA Section 8.
EPA has similarly provided extensive notice
and formal hearing opportunities.
The aldrln and dleldrln suspension order
issued by the Administrator on October 1,
1974, followed almost three yean of admin-
102
NOTICES
The" formal oa-the-record decision mak-
ing process imposed by PIFRA and the
APA as a necessary prerequisite to final
cancellation or suspension would be ren-
dered meaningless if the Administrator
were to modify or reverse such orders
without notice to the public, without an
opportunity for formal hearings and
without limiting his consideration to a
formal hearing record. Such an Informal
process could greatly prejudice the in-
terests of parties to the original proceed-
ings. In the original proceedings they
had the opportunity to be represented.
by counsel, to present witnesses and to
cross-examine witnesses of other parties.
They had the opportunity to argue their
cases before an Independent hearing ex-
aminer and before the Administrator. An
informal process which modified or re-
versed a final order would not provide
such opportunities, would not protect the
procedural rights of affected persons and
would undercut the statutory scheme re-
quired by FIFRA. As the Court concluded
in DOT H, "when Congress creates a pro-
cedure that gives the public a role in
deciding Important questions of public
policy, that procedure may not lightly be
sidestepped by administrators." 439 P.
2d at 594.
Formal reconsideration of prior orders
should only be granted, however, where
there is substantial new evidence which
may materially affect the order. The pro-
visions of FIFRA relating to notice and
to the opportunity of adversely affected
parties ta join in formal hearings are
broadly drafted to permit maximum par-
ticipation in the cancellation proceedings
by other Federal agencies, the States, in-
dustry, environmental groups, and pri-
vate citizens. As the Court noted in DDT
II, "the statutory scheme contemplates
that [pesticide cancellation] questions
will be explored In the full light of a
public hearing. • • •" 439 F. 2d at 594.
With such broad opportunities to par-
istratlve proceedings. The Initial cancella-
tion notice tor the major uses of aldrln and
dleldrln was Issued by the Administrator
on March 18, 1971. Formal administrative
hearings commenced on August 7, 1973. Dur-
ing the following twelve months of hearing,
249 witnesses testified, and over 38,000 pages
of transcript and exhibits were considered
and the suspension Is now before the Court
of Appeals for the District of Columbia.-
Similarly, the two administrative proceed-
. Ings currently In progress with respect to
pesticide products containing mercury and
mlrez have Involved lengthy hearings. The
notice of Intent to hold hearings on mlrex
was Issued on March 38. 1973. The formal
hearings were begun on December 3. 1973,
and have not yet concluded. To date, over
60 witnesses have testified In those hearings
resulting In a record of over 13,400 pages. As
in the aldrln and dleldrln proceedings, a
scientific advisory committee report on
mlrex was prepared prior to the commence-
ment of the formal hearings.
The cancellation of pesticide products con-
taining mercury was Issued on March 33,
1973. The formal administrative hearings
began on October 1, 1974. and are still in
progress. Forty witnesses have testified thus
far in those hearings generating a record of
over 3.400 page*. •
ticipate in tha original proceedings, the
public Interest—and the Interests of the
parties who participated in such pro-
ceedings—requires that the Issues before
the Administrator not be rellttgated with-
out a threshold determination that there
Is substantial new evidence which may
materially affect the prior order. This
procedure does not prejudice the inter-
ests of parties seeking modification. If
there is substantial new evidence,- which
may materially affect the prior order,
a formal hearing should be convened to
adjudicate whether such evidence re-
quires modification or reversal of the
prior order. On the other hand, however,
the public interest demands that public
agencies not be required to expend
limited resources on reconsideration of
facts previously adjudicated. Public re-
sources should not be committed to re-
consider a prior final order unless there
is substantial new evidence which may
materially affect such order.
For the foregoing reasons, EPA has
adopted Subpart D to the Rules of Prac-
tice (40 CFR Part 164) setting forth the
procedures to be followed in the case of
an application under FIFRA sections 3 or
18 which requests use of a pesticide at a
site and on a pest for which registration
has been finally cancelled or suspended.
These revised procedures require that in
any such case the Administrator will ini-
tially determine, on the basis of the ap-
plication and supporting data, whether
there Is substantial new evidence which
may materially affect the prior order and
whether such evidence could not have
been discovered by due diligence on the
part of the parties to the original pro-
ceeding. In any case where it is deter-
mined, as in this case, that there is no
substantial new evidence which may ma-
terially affect the prior order, then the
application will be denied.
In any case where it Is determined that
there is such evidence, then a formal
hearing will be convened to determine
whether such evidence materially affects
the prior order and requires its modifica-
tion. In such a case, the ultimate deter-
mination will be made on the basis of the
record in the adjudicatory hearing and
the recommendations of the administra-
tive law judge presiding over the hear-
ing, taking Into account the human and
environmental risks found by the Ad-
ministrator in his prior order and the
cumulative Impact of past, present, and
anticipated uses in the future.
The procedures also provide that In
emergency circumstances the Adminis-
trator may rule on the application with-
out convening a formal hearing when he
determines that: (1) The application
presents a situation involving need to
use the pesticide to prevent an unaccept-
able risk to (1) human health, or (11) fish
and wildlife when such use would not
pose- a human health hazard; and (2)
there is no other feasible alternative
solution to such risk; and (3) the time
available to avert the risk to human
health or fish and wildlife Is Insufficient
to permit convening a hearing; and (4)
the public interest requires the granting
of the requested use as soon as possible.
FEDERAL IEOISTEK, VOL 40, NO. 68—TUESDAY, APIIL 8, 1975
-------
103
This provision for dispensing with a for-
mal hear Ins does not apply to the Loulsl-
. aaa application since the use of DDT on
cotton does not Involve a need to use the
pesticide to prevent an unacceptable risk
relating to human health or fish and
.wildlife.
Xn the case of the petition by the State
of Louisiana, notice of these revised pro-
cedures and of a tentative time schedule
•within which they would operate was
given to all parties involved in the in-
formal public hearings held In Washing-
tots. D.C.. on March 5. 1975. Because of
the March 5. 1975 notice to interested
parties, Including the State of Louisiana.
formal adoption of such procedures on
the eve of my decision as to substantial
new evidence did not prejudice the In-
terests of Interested parties including the
Stats of Louisiana. All such parties re-
ceived notice of these procedures on
March 5 and were encouraged to submit
an additional brief statement summariz-
ing what they maintained to be substan-
tial new evidence on March 10.1975. The
State of Louisiana, and other Interested
parties have submitted such statements.
In addition, the Louisiana application
was filed under FTFRA section 18 pur-
suant to which Louisiana is required to
show that there Is a pest outbreak-for
which no alternatives are available and
which will result in significant economic
or health problems. 40 CFR Part 168.
Louisiana has questioned whether EPA
is now changing the substantive standard
by"which Its application will be evaluated.
The procedures adopted do not, however,
change the substantive rules by which
the Louisiana, application will be meas-
ured. The Issues raised by the Louisiana
application under section 18 were ad-
judicated and finally decided in the 1972
DDT cancellation case. In that case the'
Aministrator was required to make, and
made, specific findings and conclusions
with respect to the risks and benefits as-
sociated with DDT use on cotton. The
Administrator's findings and conclusions
were then affirmed by the Court of Ap-
peals for tSie District of Columbia in DDT
V. Thus, no showing under section 18 of
a pest outbreak, of unavailability of al-
ternatives and of significant economic
problems could now be made without
substantial new evidence. The proce-
dures adopted clarify the application of
the general rules under sections 3 and 18
to specific cases,-such as the Louisiana
application, which in substance request
modification or reversal of a prior final
order.
' These procedures are not inconsistent
with previous EPA practice. Since the
1972 Order. EPA has received approgj-
mately 44 applications under FTFRA sec-
tions 3 and 18 for the use of DDT on cot-
ton. All of these applications have been
denied summarily on the basis that they
failed to set iorth sufficient new Informa-
tion which would warrant approval In
view oS the general human and environ-
mental risks associated with such DDT
use and enumerated in the 1972 Order.
Jn addition to She 44 DOT-eottoa re-
quests, EPA has received applications fo?
uses of DDT on other crops which were
not at Issue in the prior DDT adjudica-
tory hearings. In 1973 and 1974 DDT was
authorized for use under FIFRA section
3 for the pea leaf weevil In Idaho and
Washington. These authorizations con-
sidered the available evidence "in light of
the terms of tne June 1972 [cancellation]
order ° •> °." 39 PR at 10322. However.
the use of DDT for the pea leaf weevil
was not cancelled by the Administrator
in his 1972 Order and thus the pea leaf
weevil applications did not In substance
request the use of a pesticide on a site
and against a pest which was cancelled
by final order. In fact, the pea leaf weevil
was first detected at damaging levels in
1970 and relatively little was known
about the impact of climatic and biotic
factors on its development or about re-
sistant crop strains or planting tech-
n«-
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104
iTICIS
to explore preliminarily scientific ques-
tions which may have been presented.
The HMAC panel spent Friday. March
14. reviewing the Louisiana application
and discussing the questions presented
with the EPA hearing panel and others.
The HMAC panel did not reach any con-
clusions or make any recommendations
with respect to whether there was any
imhfftftnfr'^ new evidence which may ma-
terially affect the 1972 Order. I appreci-
ate the HMAC panel's conscientious ef-
forts and in reaching my decision I have
taken into account my brief discussions
with them.
m. Hazards From The Requested Use
of DDT. Very little evidence concerning
human health and the environment was
actually presented by Louisiana during
the Informal proceedings. Certainly there
is no evidence before me that would mit-
igate the clear findings of Administrator
Ruckelshaus in 1972 with respect to en-
vironmental harm and risk to man posed
by DDT. In fact, data produced since the
1972 hearings that have been called to
my attention reaffirm and augment the
serious nature of the environmental and
human health hazards posed by DDT.
There is no dispute that the use of
2.25 million pounds of DDT in Trfffilffitu"1-
. tola year would have serious adverse en-
vironmental effects irrespective of any
good faith educational or regulatory re-
strictions that might be Imposed by
either the Federal Government or the
State of Louisiana. In its application
(La. App. at 10), Louisiana stated that:
It la recognized that the use of DDT, even-
when the precautions outlined above are
taken, will result In widespread contamina-
tion of the environment with undesirable
residues of'this chemical.
However, Louisiana adds, without sub-
stantiation, its belief that:
Even the most severe of the localized ef-~
feeta are unlikely to be of more than ex-
tremely short duration. (La. App. at 13).
I cannot agree either that the severe
effects of widespread contamination and
undesirable residues which result would
be only local or that they would be of
extremely short duration.
There are certain basic characteristics
of DDT that are indisputable. These In-
clude its persistence, mobility and broad
range of toxicologies! effects. Perhaps
the most insidious of its characteristics
is the fact that the most serious of DDT's
toxicologlcal effects are chronic or sub-
chronic and most often of an irreversible
nature. Such effects are not normally ap-
parent by routine scientific observation
until it is too late. This is cause for the
exercise of'particular vigilance and scru-
tiny in the evaluation of any request for
the use of tfr<« compound.
The particular use hi question here
would In my opinion present conditions
conducive to the widespread contamina-
tion and dispersal of DDT throughout
the environment There Is little question
but that the aerial and ground spraying
of 2.29 million pounds of DDT In the
August climatic conditions of Louisiana
would result In considerable off-target
drift and evea more significant volatil-
ization and environmental dispersion of
the compounds. There is ample evidence
in the 1972 record of the volatility and
persistence of DDT.
One of the principal restrictions pro-
posed by T.f^"**""- would limit DDT ap-
plication to one-half mile from dairies
or forage, silage, and grain crops used to
feed dairy animals. Similar type restric-
tions were proposed and explored In the
1972 hearings and it was concluded then
that such limitations simply could not
curb the environmental contamination
that follows from this type of DDT use.
Indeed, Administrator Ruckelshaus con-
cluded in 1972: "I am convinced by a pre-
ponderance of the evidence that, once
dispersed, DDT is an uncontrollable, du-
rable chemical that persists in the aqua-
tic and terrestrial environments." (1972
Order, 37 FR at 13370). Included In the
1972 General Findings were the follow-
ing:
A. No directions for uso of DDT. even If
followed, can over the long run completely
eliminate DDT's Injury to man or other
vertebrate «««m*i«
' B. No warning or caution for use of DDT.
even If followed, can over the long run pre-
vent injury to living """« and other verte-
brate animals (37 FR at 1337S, VH).
Many examples of DDT's ability to
persist and move in the environment
were presented in the 1972 hearings.
Perhaps the most dramatic example was
the discovery of DDT in the wildlife of
Antarctica, where of course it had never
been used. This continent, with its ice
shelf, lies over 600 miles from the tip
of South America, over 1,000 miles from
New Zealand, and over 2,000 miles from
the tip of South Africa, which are the
closest possible sources for its DDT con-
tamination. From these examples, one
can see the extreme unlikelihood that
any of the proposed restrictions, e.g.,
one-half mile aerial application restric-
tion around dairy farms, etc., win miti-
gate the resulting DDT contamination of
food, feed, air and human water sup-
plies as well as fish and wildlife in prox-
imate as well as distant areas.
The significance of my
-------
m
1873 a team of Rasstea
scientists reported the results of & mul&=
Beneraaca DDT feeding study IE waicfc
two groups of A-straia mice were fed
10 and 50 ppm DDT in ths parenfe sea-
eratioa while five succeeding generations
were fed 10 ppm. DDT caused a signif-
icant Increase in lung tumors at both
feeding levels in the parent groups. All
of the five succeeding generations showed'
an increase in lung tumors over control
animals; the increase was significant sta-
tistically- In the second, third and fourth
generations fed 10 ppm, the only dose
so tested. Int. J. Cancer: 11, 688-693
(1973). This finding of DDT induced car-
cinogenicity at a site other than the liver
supports the results of an earlier report
by a Hungarian team which showed DDT
feo cause a progressively significant in-
crease in leukemia and other malignant
tumors afc several different sites in the
second through the fifth generations of
mice fed approximately 3 ppm of DDT
in the diet. Fd. Cosmet. TosicaL, VoL 1,
215-222 (1969).
In March 1974 the fisst study of the
effects of the long term feeding of p,p'
DDE. the principle DDT metabolite found
in all humans and in the highest quan-
tity of all of the metabolites, was re-
ported. At the only feeding level tested
(250, ppm) rp,p DDE was shown to 03 an.
extremely effective liver carcinogen la
both male and female mice, but particu-
larly in females in which there was a
98 percent Incidence of tumors compared
to only 1 percent in the control animate.
Another DDT metabolite. p,p' ODD fed
aC the same single feeding level caused a
significant Increase in lung tumors.
Journal of the National Cancer Institute,
VoL 52. No. 3, March 1974.
In addition, evidence reviewed by me
to September 1974 that had been in-
troduced in the Aldrin/Dleldrin suspen-
sion hearing revealed the apparent
synerglstic effects on the development of
tumors in mice fed DDT and Dieldrin in
combination. (39 FR at 37268) While
such a possibility had long been feared
this was the first evidence actually dem-
onstrating such effects. Knowing that
these two compounds are stored in the
tissues of the entire population of the
U.S. and are and have been breathed and
ingested simultaneously for. years Is an
added cause for serious concern.
As I stated in my Order of March 14th
denying the Louisiana application, these
recent findings tend to reaffirm and aug-
ment the cancer hazard of DDT perceived
by Administrator Ruckelshaus in 1972.
Had the quantum of cancer evidence not
changed since 1972 there is no doubt but
that the basis for the 1972 finding of a
carcinogenic risk would still lead me to
concur completely with the seriousness of
the cancer risk expressed in the 1972
Order. (See my October 1, 1974, Order
Sospendlnf? Aldrtn/Dieldria Registra-
tions. 39 FR 37265-72). What has been
•called to my attention in these informal
proceedings by $he National Auduboa So=
eiefcy cad others concerning more recent
cancer testing does, however, convince
me thafe the cancer hazard is nog as "re-
mots" as previously thought.
ESy se<0te3 oS tfea evidence ia the reeenfe
susnensioa proceeding
to ligM certain additional fss=
tea bsastog on my present consideration.
Tee apparent DDT/Dieldria synergistic
earciaoEieaie response discussed above is
one such factor. Za addition,! notice thafe
much has been raised in the past con-
ceraiag the relevsace of carcinogenic re-
sults achieved in experiments using "high
levels" of a compound, an issue that I was
nofe faced with in the Jdrtn/Dleldria
case. The only dosage level cited in the
1972 DDT Order as producing tumori-
geaic results was 250 ppm, although
reference was made to a second study in
which it is known that 140 ppm was the
feeding level used. We now have evidence
that DDT is capable of causing a signifi-
cant Incidence of tumors in test animals
afeleve'' •? IOT^ * , 2 pom in the diet, the
lowest dosage ever tested.
For purposes c" Deference, it shoukl je
noted that in 19V <
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106
NOTICES
fish and. wildlife." Later In his 1972
Order (id. at 13373), Mr. Rur.kHshftua
reiterated this conclusion: "the Agency
and EDP have established that DDT Is
toxic to non-target insects and animals.
persistent, mobile and transferable and
that It builds up in. the food chain. No
label directions for use can completely
prevent those hazards."
I am convinced that the use of 2.25
million pounds of DDT in Louisiana this
year would result in adverse Impact on
fish and wildlife, both in Louisiana and
in surrounding areas. Since environ-
mental hazards were covered in such de-
tail in the 1972 Order and since no new
evidence has been Introduced to refute
those' fln«Mnga i hereby Incorporate by
reference those appropriate discussions
and findings from the 1972 Order which
deal with the adverse effects of DDT on
fish and wildlife.
Moreover. I am mindful of the un-
fortunate economic consequences that
have been suffered by various food and
feed industries as a result of pesticide
residues in excess of established toler-
ances or action levels. In this particular
situation the Louisiana shrimp and fish
Industries as well as beef cattle, dairy
pnA nntmai feed producing industries are
all innocent bystanders to the use of
DDT on cotton. Nonetheless, they still
run the real risk of suffering adverse
economic consequences from resulting ex-
cessive DDT residues. The uncontrol-
lable nature of the compound and past
experience teaches us the Inevitability of
finding Impermissible residues of DDT in
certain of these food and feed commodi-
ties as a result of such massive nearby
use.
IV. Need For the Requested Use of
DDT! I adopt the report of the EPA sev-
en-man review panel which is attached
as an appendix to this Statement. The
panel reached the following conclusions
with respect to the requested use of DDT:
1. Average cotton yields have declined In
the last two years as compared to the preced-
ing ten years. However, there Is no evidence
to Indicate that any meaningful conclusions
concerning the relationship of yields to the
presence or absence of DDT can be drawn
from such a comparison;
2. The tobacco tmdworm Is but one of many
factors which affect yields, and it Is quite
clear that no evidence was presented to sap-
port the proposition that the tobacco bud-
worm was the principal cause, of reduced
yields In the past two years.
3. The tobacco budworm has become a late-•
season cotton pest; however. It Is not clear
that the predominance of this pest occurred
as recently as three years ago; instead. It may
have risen to Its present status prior to 1972.
Furthermore, because of resistance problems,
it Is Just as likely that the tobacco budworm
•will remain a late-season pest whether or not
DDT or methyl parathlon or any other cur-
rently available pesticide Is used.
4. The Louisiana estimates of economic
losses totally Ignore the numerous factors
which affect cotton yields. The underlying
assumptions on which the estimates are
based are Inconsistent with actual experience
In Louisiana and are contrary to sound ana-
lytical methodology.
5. There Is DO conclusive evidence to In-
dicate whether the DDT mixture caa be ex-
pected to be effective In controlling tobacco
budworm In 1975.
6. Louisiana baa not demonstrated that all
currently registered Insecticides are Ineffec-
tive against tobacco budworm.
7. A repetition of cotton Insecticide short-
ages In 1974 la unlikely to occur la 1975.
8. It to Impossible to predict the likelihood
of a tobacco budworm outbreak in. 1973 at
this time. However, if past cotton production
practices are continued, and more sophisti-
cated production methods are Ignored, the
lllfHIhnnd of an outbreak will be rnriancM.
0. Louisiana has not taken fullest possible
advantages of Integrated pest management
techniques -which other states have found to
be of considerable benefit.
A. Economic Impact. The major prob-
lem which Louisiana wished to address
through the use of DDT In 1975 is one
of preventing additional economic loss
to cotton producers who were already
hard hit in 1973 and 1974. Estimates of
total potential economic losses have been
made by both the State and USDA. The
State estimates are derived from an
assumed continuation of estimated losses
in 1973 and 1974; the USDA estimates
from an economic model. . •
In its application, Louisiana estimated
that tobacco budworm "specifically
caused the loss of approximately 50-60
million dollars in 1974 in direct and in-
direct loss to the cotton industry" in the
State. An economic analysis Included in
the State's application estimates that
cotton producers' combined 1973-74
losses were $50,645,250 and that in-
creased unit costs arising from reduced
yields, i.e., unit costs of production, gin-
ning, and warehousing, were $17,773,500.
These estimates were based on the fol-
lowing assumptions which tend to innate
the estimated losses: (D all losses in
yields would be attributable to the un-
availability of DDT, (11) the total har-'
.vested cotton acreage was the same In
both 1973 and 1974. Oil) lint cotton
losses per acre were 111 pounds, and
(iv). that the relative efficacy of DDT
compared to alternatives, is high. This
approach overlooks other factors which
seriously affect cotton yields, such as,
weather, planting time, disease, etc. See
Report of the EPA Special Review Group
(EPA Report) at 6-D.
The USDA analysis of potential.eco-
nomic losses was $15.8 million in 1974.
Even this analysis' may be subject to
revision because it rests, hi part, on
efficacy data which the Special Review
Group found to be of questionable
validity. See EPA Report at 6 E/F.
No matter which estimate is taken, it
must be compared to total Income meas-
ures for the State to put the estimated
Impact into the perspective of the State's
economy as a whole. Estimates of farm
income and State income from 1972
show that these values were $800 million
and $14 billion, respectively. Thus, while
the estimated losses constitute approxi-
mately 7.5 percent of total farm income,
they do not appear to represent a major
upsetting factor to the total economy of
the State. The potential economic effects
must therefore be viewed In their proper
context of localized mlcroeconomic-dis-
locations. This Is not to say that such
effects are to be dismissed lightly, since
they may constitute severe burdens on
Individuals—farmers and ginners and
their employees—and gn other industries
in tbe affected parishes. Yet. even If DDT
were to achieve the results anticipated by
the State, it would have the effect of
alleviating cotton growers' economic
problems while, at the same time, impos-
ing certain health, environmental, and
economic costs on third parties. e.g..
dairy farmers, livestock producers, com-
mercial fishermen, anri so /yn The esti-
mates of potential loss discussed above
include only the direct and indirect costs
which might arise as a result cf reduced
cotton yields; there has been no allow-
ance made for the increased costs, eco-
nomic and otherwise, of n^ng DDT as
requested in the State's petition. Nor
have the offsets available by unproved
utilization of* alternative pest control
techniques or -alternative crops been
taken Into account as reductions to the
estimated gross economic loss.
One of the key assumptions made in
the petition is that the economic prob-
lems of Louisiana cotton growers are
linked to the lack of DDT. Another is
that all losses are attributable to damage
by the tobacco budworm. These assump-
tions fall under crHicftl ^T^giysi.^
To begin with, it'is necessary to ex-
amine some of the Institutional factors
that have affected the economic situa-
tion. An institutional change of immense
importance occurred in 1974 with the in-
troduction of the new cotton allotment
program. This program was part of the
1973 Agricultural Act, and It required
important changes in agricultural poli-
cies and philosophies, placing a great deal
of reliance on the free market and re-
quiring a good deal more judgment on
the part of the farmer than was required
under the previous programs. With re-
spect to cotton, the Act replaced an
across-the-board payment of 15 cents
per pound with a target price program.
Le., when the national average price for
a calendar year falls below the target
price (currently 38 cents per pound).
growers are reimbursed for the differ-
ence. In regard to the shift away from
cotton subsidies, the Special Review
Group found that cotton growers "are in
a transitional period requiring adjust-
ments not only in their production plan-
ning but also in their handling of factors
which affect cotton yields and pest con-
trol, which, in many instances, are inter-
related." See EPA Report at 6D.
Another important change made by
the Agricultural Act was the introduction
of a disaster payment program, which
economically protects farmers if they
lose more than one-third of their crop.
In t.he circumstance where farmers plant
cotton on non-allotment acres and suffer
a large yield-per-acre loss for any season.
they often are not eligible for disaster
payments. This situation was relatively
common in Louisiana last year, thus in-
creasing the farmers' economic disloca-
tion.
In the past two years, cotton price
fluctuations also worked to the growers'
disadvantage. In 1973, much of the cotton
crop was contracted. From a market
point of view, 1973 was one of the cotton'
FEDERAL REGISTEK, VOL 40. NO. 68—TUESDAY. APWl B, 1975
-------
107
Industry's better years. But sines most
growers sold their crop early to fufcusaes
speculators, the latter were the primary
BjeneSciaries of rising prices during the
year. Afc the fregtnnlng of 1974, cottoi
growers were particularly optimistic.
. JFVarecasts and expert thinking were ori-
ented toward aa extremely goad cotton
apparently relying OQ high price
mates. Zss Louisiana, acreage jumped
from 530,000 in 1913 to 665,000 in. 1974. A
large portion of this increased acreage
was planted under high risfe conditions,
since many farmers could not expect to
be covered under the disaster payments
provisions of the 1973 Act, and a good
deal of cotton was planted after the op-
timum planting time (before May 15 ia
Louisiana), thereby increasing the likeli-
hood of a late-season tobacco budworm
problem. In addition, with their 1973 ex-
perience in mind, many growers chose
not to contract; nationally, about 20
percent contracted In 1974, compared to
75 percent in 1973. Unfortunately, the
market again worked to the growers'
detriment. Toward the end of the grow-
ing season, prices fell precipitously. With
costs having increased significantly, cot~
ton growers were caught in a severe cost°
price squeeze, and many of them suffemS
serious losses.
Naturally, the economic factors thaft
have affected cotton production in Lousl-
ana In recent years Have also affected it
In other States. Furthermore, Louisiana
has not been alone in experiencing a
downward trend hi cotton yields hi the
last few years. The same thing has hap-
pened In all the Mississippi Delta cotton-
produclns States. In fact the USDA Crop
Reporting Board's report dated Janu-
ary 10,1975. shows that the other States
in this region all have experienced!
sharper declines. According to that re-
port, yields in 1974, compared to 19S&-73
averages, declined 28-29 percent to Ar-
kansas, Mississippi, and Tennessee; 38
percent to Missouri; and 7.5 percent ia
Louisiana.
In summary, 1974 was aa exceedingly
bad year for cotton producers tn Louisi-
ana and elsewhere—market prices were
Jow, costs were high, and they were faced
with adverse natural phenomena such as
whether and Insects. On the institutional!
side, the commodity market wes incor-
rectly assessed.
B. Tobacco Budworm, Louisiana's ap=-
plication indicates that the tobacco bud-
worm has reached outbreak proportions
and has become resistant to registered
insecticides.
An increase In budworm infestaMora
has been observed in recent years, partic-
ularly during August and September
when cotton Is most susceptible to in~
festatlons of this pest. Resistance to in-
secticides, including mixtures containing
DDT, has apparently played a part to
the recent predominance of this psst.
However, it Is unclear when the pre-
dominance of the budworm in the late-
season occurred. It is possible that both
an Increase in resistance combined wJtb
increased populations has been a devel-
oping tread which started in years when
DDT was used and has continued up to
the present time. The tobacco budworm
may be showing resistance to all Insecti-
cides, including DDT. In any event, the
data, furnished to the Special Review
Group, have not established when the
tobacco budworm outbreak occurred.
• Louisiana, maintained that the DDT
mixture was the only effective method
of controllinr the tobacco budworm. The
experimental testing designs used by
Louisiana make it impossible to attach
any significance to «ne claimed differ-
ences to the relative efflcacy of DDT over
other currently registered insecticides.
In fact, some of the date, submitted by
Louisiana showed that one alternative
pesticide had nearly the same effective-
ness as the- DDT-tosaphene-methyl
parathion mixture, and that certain
combinations of pesticides had a signifl-
car* '•npar*' )u • Uton yields. EPA Re-
port SF. Accordingly., alternative con-
trols for tt° tobacco bud worn* are
available.
COKCZ.U3XOH
A great; deal of consideration has been
given to all aspects of the Louisiana, ap-
plication for the use of DDT on cotton
to 1975. X.have carefully reviewed the re-
jjorfc oS th® SPA semi-man panel who
listened to the testimony presented dur-
ing the five days of informal hearings
and who read all of the written exhibits
.submitted to the hearing record. The
•written summaries of the evidence sub-
mitted by interested parties have been
read by me and discussed with my staff
and advisors. Every opportunity has been
given to the State of Louisiana to present
its case to the most favorable light pos-
sible. In accordance with Subpart D oS
SPA's Rules, and Practice for Applica-
Sons Under sections 3 and 18 to modify
Previous Cancellation or Suspension Or=
ders (40 PR 12261). 1 have reviewed the
totality of the evidence to as effort to
determine whether the applicant has
pKsssated substantial new evidence
which may materially affect the 1972
Order cancelling virtually all uses of
DDT. The 1972 Order was an Important
EPA action reached after extensive ad-
ministrative and judicial proceedings.
The 1972 Order weighed all risks and
benefits of DDT use.
I am convinced at a minimum that no
substantial aew evidence exists which
may materially affect the 1972 Order
as St relates to the cancellation of DDT
registrations for cotton. Certain evidence
presented, moreover, would indicate that
the environmental and human risks
eausclated to the 1972 Order may now
be of even greater magnitude than to
1972. In addition, I flnd that the use of
DDT on cotton to Louisiana this year is
not necessary. There 8s no substantial
evidence that DDT would be efficacious
or that alternative chemical pesticides
and other control techniques are un-
available or inefficacious.
Accordingly, 1 incorporate this state-
ment of reasons toto my Order o£
Marea 14, 197S, denying the section 18
application by the State of Louisiana for
emergency use of DDT on cotton in 1975.
Dated:-March 17,1975.
RUSSELL E. TRAIN,
Administrator.
To: Acting Deputy Assistant Administrator
for Pesticide Programs.
From: Special Review Croup.
Subject: Lo tils lane.'3 Application for Emer-
gency Exemption. •
This memorandum Is tho report of the
special review group appointed to evaluate
Louisiana's petition for an emergency exemp-
tion to us® a maximum of 2.25 million pounds
of DDT to control tobacco budworm on cot-
ton, this year.
1. Tho Issue.
Tho Issue addressed In this report is
whether:
a. The applicant has presented substantial
aew evidence which would Justify reconsid-
eration of the DDT cancellation order, Inso-
far as this requested use of DDT Is concerned,
and which was not available at tho time the
cancellation order was Issued, and
b. Whether aucfi evidence could not,
through the exercise of due diligence, have
been discovered by tha parties to the can-
cellation proceeding prior to tho issuance of
the Sncl order. ";
For tha purposes of this report, tho de-
termination to be- made on the above Issue
Is referred to as the determination off whether
there Is "substantial ne?7 evidence."
3. Background.
On June 14. 1972. after three years of In-
tensive administrative and Judicial Inquiry,
which included seven months of formal ad-'
mlnlstrative hearings under the Administra-
tive Procedure Act. the Administrator Issued
an order cancelling most DDT registrations.
Including all registrations for use of DDT to
control cotton Insects. This order was upheld
by the United States Court of Appeals for
the District of Columbia. At the time of the
Administrator's cancellation order, the pri-
mary DDT uso was for control of cotton pests
and amounted to 10 million pounds annually.
Thus, Louisiana's request to use 2.25 million
pounds In 197S represents approximately one
fourth of the amount of DDT used on cotton
ot the time of the cancellation order.
Lest year, EPA allowed two uses of DDT,
i.e., 600,000 pounds to control tussocK moth
and 10,000 pounds to control the pea leaf
weevil. Unlilce the use of DDT to control
cotton insects, which was a registered use
until the cancellation and which was a
major Issue in the cancellation proceed-
ings. Its USQ to control tussocfc moth and
pee. leaf weevil was not registered at the
time of the cancellation and was not con-
aldered In the cancellation proceedings.
3. Louisiana's application.
Louisiana Is requesting an emergency ex-
emption for the use of 3.25 million pounds
of DDT in combination with toraphene and
methyl parathton to control a possible
tobacco budworm Infestation. There would
be up to flvo applications of the DDT mix-
ture at flve-day intervals. On e, per acre
basis, each application would consist of one
pound of DDT plus two pounds ot toxaphene
and one-fourth to one-half pound of methyl
parathlon. DDT would bo applied only when
there Is o tobacco budworm infestation at
or above levels at which economic injury
would be expected to occur. Use of the DDT
mixture would not begin, until August 1975.
Farmers would be urged to tatre certain
measures to mlnlmlas use of DDT and
minimize its environmental tarpact, but for
tho most part these measures woulcJ not teo
mandatory.
FSDEOAl DE@!STER, VOL. 40, NO. 68—TUESDAY, APHIt 0, 1WS
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108
Louisiana* petition wa* delivered. •*»_
on January 34.1973. A notice of me receipt
of th* pettttoe, was published February M.
1978. along w«» a notice of public baartag
to be held on February 3T-3S) In Baton BuugB
^mfl \f*rr+i s m Washington, DC. The hear-
ings In Washington were extended to ifte.
4th and fth of March upon notice given to
Baton Bouge. Krtensive testimony wa* pre-
sanlinl by representatives of farm earlron-
mentat groan* and Federal agendas and by
various experts and Individual rlt1«niit, These
hearings were conducted by the special re-
new group for tfca purpose of gathering
information to evaluate Louisiana's petition.
5. Analytical Framework.
For purpose* of evaluating Louisiana's ap-
plication, th* major representation* were
Identified and broken down Into the follow-
ing major premises In order to understand
the' underlying assumptions on which the
retnimntiUnm were based:
A. Cotton yields have declined by an av-
erage of 131 pounds per acre In the last two
years as compared to the preceding ten.
B. Failure to control tobacco budworm baa
been the principal cause of the reduced
yield* In the past two years.
C. Th* tobacco budworm problem has
T—»•««•«« outbreak proportions In the last
three yearn ant has .become the major late-
D. The reduced yield* In the.last two years
have had a serious economic Impact.
B. The-mixture of DDT-toxaplieiie-nwthyl
patathloa was effective against the tobacco
iHjsiamui when tt wa* last used sad can
be expected to be effective this year.
r. Currently registered insecticide* are In-
•Caotive agains$ heavy Infestations of to-
ot. Then wfll be a shortage of currently
H. It is anticipated tnat tobacco bud-worm
•will be a. major problem again In 1979 and
will .significantly reduce cotton yields.
X. The requested use of DDT poses no un-
reasonable risk to human health.
J. Cotton gn/weia will use DDT In accord-
ance- with a program dealgned to control
tti use and mit^mteo rnvinnian*nttl Impact.
K. Integrated pest maaagem»nt teeh-
aicruea are uaaful but will not replace cfaera-
ioai control when oatineaka occur.
«. Analrsla.
A. Cotton yield! have declined by an av-
erage of ill pounds per acre to the last
two years as compared to the preceding ten.
B. Failure to control tobacco bndworm baa
been the principal cause of the reduced
yields in •*« paat two yean.
These statements represent a narrow view
of what has been-happening In Louisiana's
cotton-productog Industry. They overlook
t<(p^<>»Ti^ d»ta about cotton production In
Louisiana in recent years and Important
facton affecting cotton yields, .
Lontsiana'a yield data are presented in
Attachment A, which Is a reproduction of
a table included In the State's application.
Par OOP veal miCT. ino State's graphic pres-
entation of the same data Is reproduced as
Attachment B.
Then Is a serious question as to whether
tast three years uxi
has become the major- late-season oottor.
pest* • •
Lotrtslana-offlelals have untiled that then
has been a.marked change in the seasons
pattern of tobacco bndwonn Infestations
There generally are two periods of Heliothii
Infestation la cotton; the first one ocean
during June and early July, while the seeont
UegUis th* following month and continue!
until the crop ma-tore*, when It Is no longei
•vulnerable to' attack by the tobacco bud-
worm. Historically, tobaooo budworm has
been the predominant Insect during the early
infestation (which Is less serious because the
cotton plant Is stin capable of compensating
for Insect damage), while bollworm has been
predominant later in the season. According
to Louisiana's date, a shift has occurred. In,
that tobacco budworm la now predominant
during the later infestation. This shift Is
suggested by the following table, which Is a
reproduction of one appearing In Louisiana's
application; however, the absence of data for
the period 1935-1971 does not permit any In-
ferences to be drawn as to precisely when the
alleged shift occurred:
relatively cooU cloudy conditions with
slye rain during late August and September
resulted In poor growing condition* for ma-
turing th* crop and one of Va» most (word
mt legible on xerox eopy> outbreaks of boa
tot an record la Louisiana. aCany
fc*»» •tfesbpted all of their tosaaaV
of cause, to SeHetUt
of HeliatU*
firm cetton th*t wtrt
T«r
Month
U52 19C3 18M U72 1973 1074
_____ «
....... ____ ,_ (
September _ . ____ . 3*
B
2
9
« ...... a*
I 74 22
3 85 91
SS
The increased level of late-season tobacco
budworm apparently is related to the in-
crease in tobacco budworm resistance to In-
•ecttddal control. This theory has been pro-
pounded by Dr. Graves. Louisiana ^tate Uni-
versity, with respect to tobacco budworm re-
sistance to organophosphorous compounds.
B is supported by data reported by Baona
A Quarter-Century of Cotton Insects
in tfae Brazos Valley). In analysing the shift
m tobacco bndworm population levels m the
VOL. 4«, N3. ««—TUESDAY, MM «, IvTS
-------
10
Brazos Volley (Texas) . between 1982-72.
Banna stated that. at the beginning at
this period.' tobacco budworms were
highly resistant to chlorinated hydrocar-
bann but could ba controlled with high
doeas of organophosphorous Insecticides. A'"
this time bollworms hod not developed
any massive resistance. At the ond of
the period tobacco budtrorms had doveloped.
resistance to organophoaphates also; the
boUworms were resistant to chlorinated hy-
drocarbons but not to orgnnophoapnorous
materials. For the last three years, consider-
able budworm problems have occurred la
late-maturing fields.
It is emphasized that pesticide resistance
In the tobacco budworm In Texas developed
first to organociilorlne lnscctictd=s (DDT-
toxaphene) and then to org^nopfccsphorous
Insecticides (primarily methyl parathlon).
Louisiana's date do not show exactly when
the shift In tobacco budworm Infestations
occurred, but resistance to DDT-toxaphene
In Louisiana was noted by Dr. Graves In 1966.
Dr. Rousael stated that In the decade 1983-
72 the combination of DDT-toxaphene-
methyl parathlon was applied an average of
1O times psr aero per season on cotton grown
Ui Louisiana. Obviously, at this rate of use.
tho selection pressure for development of re-
slstonco by tobacco budworm to the DDT
mixture was Intense. Dr. Graves' resistance;
data, as submitted Us the State's petition,
ohotra that of the 12 sites v/here Insecticide
resistance was detected la 1972—74 sampling.
seven had relatively nigh levels of resistance
to DDT-tosaphene. Thus, the contention
that the tobacco budworm population shift
has baen very recent (after 1072) and! duo
primarily to resistance to organophosphqrovss
compounds Is not entirely supported by date,
though It could possibly be true.
In contrast, Dr.'PImentel, Cornell Univer-
sity, has noted In his testimony on the
.tobacco bud worm problem In Louisiana that
•from 1967 through 1972, -when DDT was re-
moved, you will note there Is an average de-
cline In yield par acre of cotton of ebout 30
pounds 00° Nov7, If you take the reduction
from 1972 to 1973, we have B reduction of 28
pounds. And then the reduction-from -1973 to
1874 is & reduction of 32 pounds. So that the
average reduction In yield for those last two
years Is esactly equal or similar to the re-.
ductlons In yield that you had tho previous
0 ° ° 6 or 7 years. So that I say the trend
hers as being I would agree with my col-
leagues that there Is a decline In yield, aafl
I would a^ree with Dr. Newsom that this is
probably a good deal duo to resistance of tho
budworm, if we can go by the experience that
occurred in Mexico and Texts, that this re-
sistance Is increasing and there !s & decreeso
In yield, but tbet this reduction In yield baa
not Increased following the remove! of DDT,
it has only remained constant because tho
Insects are becoming more and more resist-
ant to ell of the Insecticides used." It shoulti
be noted that more recent 1974 date, which
had not been brought to Of. Plmentel's at-
tention. Indicate that the 1B73-1974 yield re-
duction was 51 pounds. The additional re-
duction may bs due to Increasing tobacco
budworm resistance to oil Insecticides and/or
to the other factors that may aavo affected
1874 yields (seeTB).
D. The reduced yleldo in 4ha lest frEso yecro
Slave had a serious economic impcct.
In his letter transmitting Loulolana'o op°
plication, Governor Edwards estimated tha£
tobacco budworm "specifically caused tho loss
of approximately 60-30 million dollars ta
1*7-5 in direct and indirect loss to the cotton
industry" In Louisiana. An economic analysis
in the State's application ostlmotso that ctrt=
ton producero' combined 1B73-7S lossso xroso
0&C.S48.260 cud SsoS increecsd oast ccsta
arising from reduced yields,, l.o^ unit costo
oS .production, ginning, and warehousing,
were 017.773,500.
The 050,045.250 figure la an upper estimate
bcssd on five assumptions, ono of which Is a
lint'cotton price of 80 C per pound. Histori-
cally, the highest price paid to cotton pro-
ducero has bean 58.44 per pound. In 1973. the
overage price was 37.61! per pound. In 1974,
the t.verage price was 40.3un
2&tQ tno dollar value of ther economio id-.
pact oa cotton producers.
In an attempt to predict the economic Im-
pact of not using the DDT mixture this year.
a consultant to USDA has employed a model
that takes Into account a number of factors
that affect cotton yields, including amount
and timing of rainfall, cotton acreage, boll-
worm infestation, and boll rot. It was as-
sumed that use of the DDT mixture would
eove two Insecticide applications per acre and,
in accordance with the State's controlled
use program, involve $3 per aero for scout-
Ing and supervision costs. The resulting esti-
mate of the cost of not using tho DDT mix-
ture is about 016.8 million. The methodology
used here Is much sounder and more sophis-
ticated than that employed by Louisiana In
estimating 1973-74 losses. Though there has
not been time to examine the USDA model
In detail. It should be noted that the assump-
tions as to relative efficacy of the DDT mix-
ture and alternatives are based on the test-
Ing performed in Louisiana in recent years
and therefore must be considered in light of
the analysis presented in 8 E/F.
There Is no question that gome notable
changes have occurred In the economics of
cotton production over the past few years.
Starting in 1674, cotton growers no longer
receives from USDA a subsidy fortxrtton pro-
duced on their allotted acreage. Previously,
they received 16$ par pound subsidy. In tho
DDT cancellation order, the Administrator
Botetf that there was testimony that "this
subsidy Is the difference between profit and
&reck-even (but that) it is not clear whether
or not break-even includes E. return to the
farm corner in terms of salary or return on
Ills investment." The legislation repealing
ffloio subsidy ties enacted in 1973.
Tho legislation now In effect provides for
Efederal payments to cotton growers of an
amount equal to the difference between the
national avcrago market price during a cal-
endar yeas- and a so-called target price. In
X87<5, the fliat year in which this new policy
VTca in effect, cotton prices declined sharply
Sato la tsio yeos: nevertheless, because tha
esJentto-yocs1 overage wca above tho t&rgefc
prica (38""? not been
alone In experiencing a downward trend In
cotton yields in the last few years. The Bams
thing has happened in all the Mississippi
Delta cotton-producing States. In fact, the
USDA Crop Renortlng Board's report dated
January 1O. 1975. showa that the other
States In this region all have experienced
sharper declines, ranging from 28-29 percent
In Arkansas, Mississippi, and Tennessee to
38 percent in Missouri.
Whether substantial new evidence baa
been presented in the economics area 13 a
difficult question. The diaculty lies largely
In determining the materiality of evidence
concerning economic changes experienced by
cotton growers in one of several States where*
such changes have occurred. It Is clear that
the DDT cancellation order dealt with the
cotton economy as a whole. No assumptions
were made that cotton-production costs and
profits In specific areas, such as Louisiana,
were the some as those In other cotton-pro-
ducing areas or that relative cotton-produc-
tion costs and profits in the various cotton-
producing areas would remain static In the
future.
The economic outlook for any single area
obviously was not the touchstone of the
Administrator's statement that: "I am con-
vinced by the evidence that continued use of
DDT is not necessary to insure an adequate
supply of cotton at reasonable cost." The evi-
dence presented by the State of Louisiana,
^rhlcn BCS accounted for about five percent
of the Nation's total cotton production in
G2g!STEa, VOL 4©, K®. 6e~>YUES9AY, APRIJ. 8, 1973
-------
fOTICES
recent years, clearly does not Indicate that
an adequate supply of cotton will not be
available If Louisiana cotton producers are
barred from using DDT.
There Is evidence that the cost of using
(the DDT mixture wtllbe lower than the cost
of using) alternatives.. such as toxaphene-
methyl parathlon or ZPN-methyl parathlon.
Taking Into account both material and ap-
plication costs and assuming that use of the
DDT mixture will save two applications per
acre during the period of treatment for to-
bacco budworm. It Is estimated that the cost
differential would range from eight to twelve
dollars per acre: this figure must be reduced
by three dollars per acre (USDA estimate)
to cover the costs of the field scouting and
supervision contemplated by Louisiana's*
program for controlling the use of the DDT
mixture.
Of paramount importance, however. Is the
lack of sound evidence on which to. base any
prediction as to tha relative efficacy of the
DDT mixture and alternatives in 1975. In
short, any economic benefits attributed to-
the use of DDT are, at best, speculative at
this time. Even were such evidence available,
it would not demonstrate that an adequate
supply of cotton could not be produced at
a reasonable cost, either In Tioulnlana or else-
where. In this connection. It should be noted
that while other States responding to a USDA
survey In November 1974 noted the existence
of some difficulty In controlling tobacco bud-
worm Infestations, Including Insecticide
resistance problems, none of them suggested
that use of the DDT mixture would be nec-
essary this year.
E. The mixture of DDT-toxaphene-methyl
parathlon was effective against the tobacco
budworm when it was last-used and can be
expected to be effective this year.
P. Currently registered insecticides are In-
effective against heavy infestations of tobac-
co budworm.
In the DDT cancellation order, the Ad-
ministrator's factual findings as to the bene-
fits of DDT Included the following:
That DDT Is useful for the control of cer-
tain cotton insect pests.
That cotton pests are becoming resistant
to DDT.
That methyl parathlon and other organo-
phosphato chemicals are effective for the
control of cotton pests.
Efficacy
The Administrator's order cancelling DDT
• registrations suggests that other registered
pesticides were considered to be at least as
effective as the DDT mixture; In contrast.
Louisiana's application asserts that the DDT
mixture Is the only one considered effective'
against heavy Infestations of tobacco bud-
worm.
A detailed analysis of Louisiana's date is
presented in Attachment D to this report.
Very briefly, this analysis Indicates that de-
ficiencies in the experimental design of the
fasting performed at State experiments sta-
tions and gaps in the date gathered during
this testing make It Impossible to draw any
clear-cut conclusions as to the relative effi-
cacy of the- DDT mixture and other Insecti-
cides. The date derived from testing In 1973
(the last year In which the DDT mixture was
tested) do not demonstrate that alternatives
to the DDT mixture were- Ineffective; indeed.
when yields In treated vs. untreated plots are
compared, at least one of the alternatives. I.e.
chlordlmeform, appeared to be nearly as ef-
fective as the DDT mixture. Looking at all
1973-74 test results. It Is apparent that sev-
eral alternatives produced yields which were
significantly greater than yields In untreated
plots. These alternatives Included methyl
parathlon used alone and iff. combination
with toxaphene, KPN. ^*"* chlordlmeforxn; a
combination of toxaphene. methyl parathton.
and methomyl; and a chlordimeform-metho-
myl combination.
Another significant gap In Louisiana's pres-
entation is the absence of data on the extent
and duration of tobacco budworm Infesta-
tions at or above the economic Injury thresh-
old level. This point Is germane to the is-
sue1 of whether five applications of the DDT
mixture at five-day Intervals, as proposed by
Louisiana, would effectively control tobacco
budworm. Louisiana's data on the efficacy of
the DDT mixture were based on "'"• applica-
tions In one test and eleven applications In
the other.
USDA's support of the statement that no
currently registered alternatives to the DDT
mixture will effectively control tobacco bud-
worm Is based on Louisiana's 1973 test date
(the deficiencies of which are briefly de-
scribed above and delineated In greater detail
In Attachment C) and on USD A testing at
Waco, Texas, In 1072. The-.Waco test was
merely a comparison of the DDT mixture
and no treatment; It had no bearing on the
relative efficacy of the DDT mixture and al-
ternative materials.
Pesticide Resistance
Louisiana officials interpret their data on
pesticide resistance as showing that resist-
ance to pesticides other than the DDT mix-
ture occurs in all the major cotton growing
areas In the State. In 1973, however, studies
of pesticide resistance included tobacco bud-
worm samples from one site in District in
and none in Districts H, 17, VI, and VH;
togetSer these districts accounted for 74 per-
cent of the cotton acreage planted that year.
Moreover, the tobacco budworm population
sampled at the site in District m was sus-
ceptible to methyl parathlon and DDT-
toxaphene. In 1973 and 1974, tobacco bud-
worm samples were collected at only two and
four sites, respectively. In short, It Is ques-
tionable that these data are truly representa-
tive, particularly since there is general agree-
ment that resistance may vary significantly
from one location to another.
Testing for pesticide resistance generally
is performed by collecting field samples of
the Insect and exposing them in a laboratory
to various doses "of the insecticides being
tested. Dr. Graves, who performs this testing
in Louisiana, testified that "the only useful-
ness -of this data Is to find the range which
would correspond to reduction In yield with
field infestations present when control Is not
achieved." In other words, he was underlin-
ing the importance of determining the effi-
cacy of an insecticide at the same field loca-
tion from which samples for laboratory
studies of resistance are collected. This cor-
relation of laboratory data to field efficacy
data for DDT and alternatives Is supported
by date from only one location in the State
(Bed River Valley, 1973). The State appar-
ently relies on the date from this one study
to show that methyl parathlon failed to con-
trol tobacco budworm when there was a
five-fold increase In resistance, while DDT-
toxaphene remained effective when there was
a two-fold increase In resistance.
Other date presented at the recent hear-
ings on Louisiana's application raise a ques-
tion about the extent to which reliance can
be placed on Just one lab-field correlation.
USDA representatives introduced a report
(Adklsson and Nemeo, 1966. Comparative Ef-
fectiveness of Certain Insecticides for ^"""g
BoUworms and Tobacco Budworms. Tex. Agr.
Bxp. Sta. B-1048) which showed that a seven-
fold increase in resistance to DDT-toxaphene
can be associated with an Inadequate level of
Insectlcldal efficacy, Le., only 91 percent In-
sect mortality 48 hours after treatment. Of
tha 13 sites sampled In Louisiana In the
1973-74 period at which some level of Insec-
ticide rff^l/rtanT was detected, seven had
tobacco budworm populations greater than a
seven-fold level of resistance to DDT-
toxaphene.
In addition to the serious questions as to
whether Louisiana's laboratory resistance
date are representative of the major cotton-
producing areas and whether the one lab-
field correlation Is meaningful, the date on
this issue are deficient In that there are no
date on tobacco budworm resistance to DDT-
toxaphene-methyl parathlon or to methyl
parathlon In combination with ether com-
monly used insecticides nor any data on
efficacy in the • field of DDT-toxaphene vs.
DDT-toxaphene-methyl parathlon.
O. There will be a shortage of currently
registered pesticides.
It is generally recognized that there was
a shortage of cotton insecticides last year.
This shortage was due largely to raw ma-
terials shortages and Increased demand aris-
ing from Increases in cotton acreage. From
inquiries to manufacturers of Insecticides
registered for use against tobacco budworm,
it Is clear that most of them expect this
year's supplies to be about the same as last
year's. Since cotton acreage in the.tr.3. Is ex-
pected to decline from nearly 14 million
acres in 1974 to about 9.5 million this year,
a repetition of last year's shortages la
unlikely.
H. It is anticipated that tobacco bud-
womt will be a major problem again In 1975
and will significantly reduce cotton yields.
Whether a late-season outbreak of tobacco
budworm will occur again In 1975 Is uncer-
tain. There Is no predictive model which
would enable Louisiana to forecast the level
of infestation based on (factors such as over-
wintering populations, flight-range potential,
reproductive capacity, etc.
Louisiana's application does Indicate that
the second-generation tobacco budworm pop-
ulation can be surveyed, beginning about
June IS, to determine the time and areas
in which damaging populations can be ex-
pected to occur and to identify areas where
levels of resistance to currently available In-
secticides are likely to be so high that the
use of the DDT mixture will be necessary.
In contrast. Dr. Rouasel testified: "I have
no idea how to predict budworm, but I do
say and I will say that, based on the ex-
tremely mild winter we have, that our pest
problem generally In the State will probably
be more severe-. However, that can be modi-
fled with weather conditions that exist In
May, June, and July." As to the usefulness
of the second-generation field surveys. Dr.
Roussel testified that "it will not tell us that
we> will or will not have an outbreak In
August."
Dr. Kewsom testified that the "problem
In Louisiana reached crisis proportions in'
1974. It may be relatively slight, or no prob-
lem at all during 1975. Fast experiences,
however, indicate that It may be expected
to Intensify."
Though there is no method for predicting
the occurrence and magnitude of future to-
bacco budworm Infestations It seems clear
that past practices in the Louisiana cotton-
producing industry, if not altered, tend to
Increase the likelihood of an outbreak this
year:
In 1973 and 1973, about 36-38 percent of
the cotton growers In Louisiana used dia-
pause control procedures, I.e., one or two
late-season applications of methyl parathlon
to reduce the population of boll weevils go-
ing into the overwintering stage and thereby
reduce the Initial infestation level la the
KDEftAL lEOISTEt, VOL 4O, NO. 68—TUESDAY, AMR 8, 1973
-------
Ill
succeeding year. Wheib.es: Bia same percent- •
age of growers uesd diapause control pro-
cedures lost year la no8 known, but In llshft
of tho losses experienced. last yea?, it 13
liliGly that growers were less Inclined to
Incur the onpense. In on? event. It Is ?en-
orolly agreed among entomologists that dla-
paaso control Is most effective when it is
employed throughout, on Infested area.
Diapause control la related to tobacco bud-
warm control la thag it can reduce the
need for in-season- use of insecticide^ to
control boll weevil infestations and thereby
proeasvQ tobacco budworm predators and pear*
ositoldo. Since boll weevil Is on Important
pest on more toon two-thirds of Louisiana's
cotton acreage, any decline in tho uso of
diapause control will tend to hsvs a sub-
atantinl Influence on the tobacco budworaa
problem.
Bectjuso of generally favorable cllmcta end
soil, Louisiana historically has produced high
yields of cotton. Naturally, the higher the
yield Is. the higher a grower's income will be.
Until recently, therefore, cotton growing in
Louisiana; has bsen oriented toward mazl->
mom production through tho lisa of Lndotep-
min&ta or late-ssason varieties of cotton end
extensive uso of fertilizer, herbicides, sad !n°
escticldes. Until Insecticide resistance • ap-
peared in tho tobacco budworm. this prac-
tice was understandable.'' Xa 1975, teeccuso
of @ie anticipated.difficulty la .controlling
late-eaason tobacco budworra Infestations.
tho State's Ouldo for Cotton Insect Control
will mrJca the following recommensSotSc-nss
Avoic! late planting.
TJso nitrogenous fertUlzera moderately,
03la7 Insecticide applications es loss ^
possible. Apply insecticides only when in=
sects reach damaging levels.
Plant soybeans when cotton cannot bo
planted within the recommended planting
interval. I.e.. April 20-May J3.
This year will ba the first one In which tho
first, second, and fourth recommendations
have appeared In tho Guide. It Is lively that
many farmers will bo hesitant to follow these
procedures until their advisability end eco-
nomic feasibility have been clearly demon-
strated. To the extent that they Ignore these
recommendations, the potential for another
tobacco budworm outbreak will bo Increased.
X. TBe requested ass of DDT poses no un-
reasonable risk to humea. health.
Ho human health date were Included in
Louisiana's application. To the extent that
such d&ta were included In testimony at the
public hearings, the data, were almost en=
Orely dcrtvedJrom studies performed and ro=
portexS prior to the DDT cancellation action.
Additionally, the only human health Infor-
mation cited by the State of Louisiana in its
summary of "substantial new evidence" con-
sisted of quotations attributed to an EPA
official extracted irons a House Agricultural
Subcommittee hearing record. At least one
porttoa of the alleged quotation cited—4.e.
"TJroo subsequent evidence confirms that.
human rtsK Is remote and that the limited
uso In question poses no unreasonable riste
of harm to man" (Fetition^for Heconsidera-
tlon. at p. 6)—does not even appear In the
Subcommittee hearing record. None of the
brief comments made in other summary
statements is supported by any evidence that
woulfi contradict tho findings on -human
be<h that were set forth In the DDT can-
cellation order. Moreover, the recent Aldrin/
Dleldrln suspension order found that DDT
reacts with another ubiquitous environ-
mental contaminant, Dleldrln, to produce
oynerglctlc carcinogenic effects. (Order of the
Administrator, at p. 3!).
3. Cotton growera trill uso DDT In accord-*
onco with a program designed to control Jto
environmental impact.
2n tho DBT cancellation order, the Admln-
tetrator*Q ototamsnt of general findings la-
dsfiHng the following:
"No directions for uso of DDT. even if fol-
toETed. can over the long run completely elim-
inate DOT'S injury to man or other verte-
°1So warning or caution for uso of DDT,
wen if- followed, con over tho long run pro-
vent Injury to living man and other verte-
brjsto finimnin and useful invertebrate ani-
mals.'0
"The UE^ of DDT in controlled situations
to limited amounts may present less risk
than usage In greater amounts, but still con-
taminates the envli-nmont."
ESoctly what would constitute a "controlled
os limited amounts" lo not do-
'o application specifies that "no
BBT will be applied until the occurrence of
tho tobacco butStjonrs has been confirmed at
population levels at o? above the economlo
injury threshold" and describes a field sur-
vey program aod relctsd distribution control
• -
-------
112
4. A strong research component develop-
ing optimum pest nf^e*"""** strategies
•ad n»w and Innovative approaches in all
phase* at cotton production, orlo&ted toward
local or regional climatic and other require-
ments, and effective flow of Information be-
tween research and Implementation.
0. Continued governmental support, Jus-
tified by documentation of actual and po-
tential benefits to producers as well as to
society.
The •potential benefits of IPM for cotton,
insect control have been clearly demonstrated
In Texas. The crux of the IPM issue in Lou-
isiana is twofold: 1) What Is the level of
the research effort In Louisiana to develop
IPM as an alternative to complete reliance
on conventional' Inaectlddal control? and 2)
What Is the level of Implementation of these
methods by cotton producers In the State?
USDA conducted a survey of cotton-pro-
ducing States in November 1974 to determine
the extent of tobacco budworm problems and
Identify needed research on this problem.
Both Texas and Louisiana have severe tobacco
budworm problems. The difference in the re-
search recommendations of these two States
Is marked, however. Basically*. Texas said:
Screen alternative chemical, biological, or be-
havior materials; place further emphasis on
pest management; and develop Heliothia re-
sistant cotton varieties. In contrast, Loulsl-
•ana suggested: Greatly expand testing of as
many new chemicals as possible; initiate a
crash program on the development of syn-
thetic pyrethroids (a conventional Insecti-
cide); seek permission to use DDT until a
new chemical Is registered; and give top
priority to an Immediate and long-range ef-
fort on resistant varieties. In short, most of
Louisiana's suggestions were directed to-
wards furherlng the use of conventional In-
secticides.
The Inadequacies of tt\ta response to the
tobacco budworm problem are further com-
pounded by the low level of grower partici-
pation in cotton IPM programs. Most of the
currently used IPM methods require a nearly
complete participation by growers within a
large area to be effective. As an example.
Dr. Brazzel. USDA (DDT Cancellation Hear-
ing. 1973, Vol 3), stated that diapause con-
trol of the boll weevil, to be effective, would
require nearly 100 percent participation of
the cotton growers within the Infested area.
la 1973, only 38 percent of the cotton acreage
was exposed to diapause control measures
la Louisiana. Another method which has
been proven to reduce the number of in-
seotlcldal applications necessary during the
course of a cotton growing season la the use'
of field scouts to determine the need for-
insecticide treatment. In 1974, 260,000 acres.
or 40 percent of the land planted to cotton
In Tr""*«li»T"t was scouted. Dr. Glower, Pro-
fessor and Project Leader for Cotton Insect
Research, Louisiana State University (1974,
A Statement Regarding the Plan to Eradi-
cate the Boll Weevil from the United States)
la a discussion of the feasibility of XPM
techniques for use in a boll weevil eradica-
tion program stated "I personally have
worked on the trap crop principle In cot-
ton for over 10 years and feel that It offers
an excellent pest management TTux-hani.m
under T-iy^.inn. conditions. T-™i1ff1f>nft is the
first state to officially recommend it to grow-
ers." Yet, only 6,600 acres, or a """*lrmm
of 1 percent of the cotton acreage In Lou-
isiana la 1974 was planted la trap crops.
This figure, however, may be below the norm
for the State due to excessive rainfall during
the 1974 planting period.
IPM techniques, such as diapause control,
trap cropping, and the Judicious use of In-
secticide* through scouting, reduce the prob-
ability of damaging pest outbreaks Including
budwosm. Tse commercial feasi-
bility of implementing these BiftthotfB to. coa-
troi cotton Insects has been demonstrated
In other States. Furthermore. IPM may be
used to avoid tobacco budworm outbreaks
by the use of early planting and early, matur-
ing varieties of cotton. The data Indicate.
however, that the level of grower participa-
tion in cotton IPM in r-Miiniarm jj inade-
quate. '
7. Conclusions.
A. Average cotton yields have declined la
the last two yean as compared to the preced-
ing ten yean. However, there la no evidence
to indicate that any meaningful conclu-
sions concerning the relationship of yields
to the presence or absence of DDT can be
drawn from such a comparison.
B. The tobacco budworm is but one of
many factors which affect yields, and it Is
quite clear that no evidence was presented
to support the proposition that the tobacco
budworm was the principal cause of reduced
yields la the past two yean.
C. The tobacco budworm has become a
late-season cotton pest; however, it Is not
dear that the predominance of this pest
occurred as recently as three years ago: In-
stead, it may have risen to its present
status prior to 1973. Furthermore, because
of resistance problems, it Is Just as likely
that the tobacco budworm will remain a
late-season pest whether or not DDT or
methyl parathioa or any other currently
available pesticide la used.
D. The Timilnlarm estimates of economic
losses totally Ignore the numerous factors
which affect cotton yields. The underlying
assumptions on which the estimates are
based are inconsistent with actual experi-
ence In Louisiana and are contrary to sound
analytical methodology.
E. There la no conclusive evidence to In-
dicate whether the DDT mixture can be ex-
pected to be effective in controlling tobacco
budworm la 1978.
p. Louisiana has not demonstrated that
all currently registered Insecticides are la-
effective against tobacco budworm.
O. A repetition of cotton insecticide short-
ages in 1974 Is unlikely to occur In 197S.
B. It Is Impossible to predict the likeli-
hood of a tobacco budworm outbreak in 1978
at this time. However, if past cotton pro-
duction practices are continued, and more
sophisticated production methods are ig-
704
600
acretJ, tao li^aSfiiced c£ aa outbreak will
be enhanced.
I. No evidence was offered to refute the
fln^ingrc contained in the 1973 cancellation
order that DDT la a potential human car-
cinogen.
J. Advene effects to the environment can
only be minimised, not eliminated. The pro-
posed controls for minimising the adverse
effects are laudable In some respects and
i^irtng m others. The likelihood of these
controls being carried out in the spirit In
which they are proposed Is subject to ques-
tion because of the voluntary aspects of
many of the most Important controls and
the considerable administrative problems
posed by the use of 2.25 million pounds of
DDT by large numbers of fanners covering
an area which may be as large as 450,000
acres.
K. Louisiana has not taken fullest possible
advantage of Integrated pest management
techniques which other States have found to
be of considerable benefit.
ATTACHMENT A TO THB REPORT off THE SPECIAL
BBVXSW GROUP
The following table Is a reproduction of one
contained in Louisiana's application (pg. 15)
for an emergency exemption (with 1974 yield
corrected to reflect more recent data pre-
sented at the public hearings):
Tear:
1963
1964
196S
1988
1967
1968
1989
1970
1971
1973
Total
10 yr. average—
5.763
578
2 yr. average...-.....^
500
400
100
•w
TEAR
-*•
1. Uutilua Cotton Held for ttw rein 1948 through 1974 la Pounds per Ku-rate* Acre.
AttutBMt B of tilt Rtoort of tin Special Unto Snx*
SSGJSTSK, vet 40, N®. &&—TUESSAY. APIIL a,
-------
113
ATT££!H£3C377 C TO 7HC QSSPC3S OP THE
In tSUo analysis of Louisi&n&'s data on tho
efflcacy of tha DDT mixture and otho? losac-
tlttdea. tho standards used In evaluating tho
data ore Identified (underlined). and tho
findings ore related bacii to tho standards.
When a peotlcldo proposed for use In an
emergency el tuition Is ono which has baea
cancelled aftzr extensive admlnlstratlvo in-
quiry, It Is appropriate thot reasonably rlg-
orouo Btondards be applied to tho supporting
date. Otherwise, tho mcra assertion that an
emergency exists. ercn If well substantiated.
would leave EPA without any meaningful
busts for judgment as to the efiicacy of the
proposed solution. In an emergency, oven
mors than In routine pest control situations,
It la vital toot tho peat control method to
bo used be effective, particularly olnco tha
coasequonces of using an ineffective method
could be much more serious.
A. What is the pyetreatmonfc Infestation
level? If multiple pest species are Involved,
what ore tho relative proportions of the
various species during too course of the
test?
The tobacco budworm and the bollwosss
ore two closely related species belonging to
tho genus Beiiothia and are similes- in ap~
peoronco to tho naned eye. In the efficacy
data tables In Louisiana's application (pp.
27-32), presorting the results of testing to
1972-71 at experiment stations in Northeeet
and Northwest Louisiana, tho State's two
principal cotton-producing areas, neither
the pntreatment Infestation levels no? the
relative levels of tobacco budwonn and boll-
worm are specified. Comments related to
Tables 1, 3, and 5 assert that tobacco bud-
worm was the primary pest during Septem-
ber. but exact figures were not given there
or in testimony at ths recent hearings.
Proper experimental design would have In-
cluded sampling in the untreated checls
plots to determine Infestation levels and
relative proportions of tobacco budworm and
bollworm before and during pesticide test-
Ing. in the absence of such sampling dots.
the esact Impact of the tobacco budworm
and tho efficacy of the chemicals tested can-
not bo determined. All that can ba said is
that control of Heliothis was or was not
achieved.
B. Were the infestation levels before
treatment and during the testing significant?
Though pretreatenent infestation levels
were not determined, the data in Tables 1-5
for untreated cheek plots indicate heavy in-
festation pressures during tho course of the
experiments. The significance of these in-
festation pressures are manifest In the re-
ported yield differences between treated tjafl
untreated plots.
C. Old the pest Infestation occur at a
point during the development of the hosfc
plant (cotton) which resulted in & signifi-
cant impact on yield or crop quality?
As Indicated in B, it Is apparent from the
data on untreated plots that the Heltotftis
Infestations did occur during & critical period
in the development of the cotton plants,
except that the comment related to Table 1
Is that "this Infestation occurred too late
to have o maximum Impact on production,
hence inferior treatments still produced
relatively good yields."
O. Woe the experiment designed properly
to eliminate or account for the Import of
indopandsne variables, e.g., boll rot, climatic
stress, presence of other Insect pests, cad
thorofo.o clearly demonstrate the Impost
off tho incactlcldo treatment?
to* data reported la Tables 1-6 wars
fcaaa feasting using a replicated.
btaefe design. Though this dealgB
nbfc Icolaio independent veslcblea, the
UK: of tsaferaated ciiecJs plots desa make It
possible to ascoun% fo? tho impact of such
vocables. This typo cf oxperUneatal design
Is widety accepted by entomologists. & con-
ditional or multiple regression analysis
•oould have bson useful In assessing tho
relative Importance of the several variables
t7hich,' might haro aSeeted yield; no such
analysis lias beon presented.
B. Was tho uso of tho '-isectielda related
.to e, reduction la tho target insect popule.-
tlrn?
Tables 1-8 provide no data on the Impact
of any insecticide on the total Heliothia
numbers or. In particular, tobacco budworm.
Louisiana's evaluation of the Insecticides is
bessd on levels of damage to squares and
balls aid on production of seed cotton per
acre. These Indices are useful, of course, but
absence of data on numbers of Insects be-
fore e—1 -fte-3 *-' *tz~.jt odd.'1 to the diffi-
culty of evaluating efficacy against :he
tobacco budworm "nils problem la exempli-
fied by the date, i Table 1 showing that
treatment with phcsvel resulted in a lower
level cf boll damage (2 percent) than did
trottment trltto the DDT mixturo (S per-
cent): however, yield la the DDT mixture-
trentea plot WES higher. USDA's Dr. Richard
Bldway testified that in his efficacy tests ho
tries to Include estimates of the tobacco
budworm population In the test plots.
F. Can comparisons cf the efficacy of the
toafc material vs. registered standards be
mode in order to determine relative efficacy?
Tho relative efflsr.cy of the DDT mixture
vs. registered alternatives is a key question.
In the absence of direct comparisons of the
~DDT mixture to the registered alternatives
tested in 1973 and 1974 (Tables 3-5). It Is
Inappropriate to use these data to support
the contention that uss of tho DDT mixture
is essential. The logical question Ui whether
the DDT mixture ^ould hnvo been effective
la 1973 and 1274; this question cannot bo
cnstyered with Louisiana's data. It Is note-
worthy that U3DA did not Include Tables
3-3 IB Its analysis of Louisiana's application.
O. Have any of the insecticides .demon-
strated any adverse effects In terms of phyto-
toxiclty?
Louisiana officials testified tost methyl
parathlon has been found to cause delays
In maturation of cotton plants; however,
no data OB this point appear in the State's
application, to addition, a review of the sci-
entific literature indicates that no signifi-
cant phytotoxle effects were noted In a test
comparing DDT-tosaphene and DDT-methyi
porathlon.
H. Ware the variations In insect popula-
tions and dom&gs and yield estimates ona-
IVEacS statistically to determine if they were
statistically significant?
Tho only statistical analysis presented by
Louisiana Is a test of the statistical signlfi-
cmeo of yield in treated vs. untreated plots.
For tho insecticide testing performed in
1972, this analysis showed that, in addition
to tho DDT mixture, all flvo registered alter-
natives tested a& tho Northeast Louisiana
experiment st&tlon and two of five tested at
tho Bed River station in Northwest Louisi-
ana yielded significantly moro seed cotton
pas- ocro than «7aa derived frcai untreated
plots. No multiple-r&ngo type analyses were
presented: such, analyses would have per-
mitted evalQa&oa of the significance of dif-
ferences in losses damage and yields among
tao varioua chemicals tasted.
JE26 Bac.7S-SO@3 Files 4-7-73; 8:4S oraj
(FSI> 33S-1)
STATE OF LOUISIANA REQUEST
USS OF DDT ON COTTON
StEterKent of Reason; for Denial
Order and Determination of the Ad-
ministrator that Reconsideration of the
Agency's Prior Order of Cancellation of
DDT for Use on Cotton is Nat Warranted.
The history of prior administrative
and judicial proceedings Involving the
regulation and curtailment of th3 use ot
DDT is long and involved. A summary oi
those prior proceedings is contained in
the preamble of my recent promulgation
ot Subpart D of the Environmental Pro-
tection Agency's ("EPA") Rulus of Prac-
tice for Applications Under sections 3
and 18 to Modify Previous Cancellation
or Suspension Orders (40 P.R. 12261).
The culmination of those proceedings
came in June, 1972, with the issuance, by
former EPA Administrator William D.
Ruckelshtaus, of a final ordsr cancslling
virtually ali uses of DDT (37 FB 133S9) .
On February 10, 1973. EPA published
notice in the FEDERAL REGISTER (40 FR
6229) of the request by the Stats of
Louisiana, under section 18 of the Fed-
eral Insecticide, Fungicide, and Rodenti-
cide Act, as amsnded ("FIFRA"), and
regulations thereunder, for the use of
pesticides containing DDT (1,1,1-trlchlo-
rophsnyl ethane) on cotton to con-
trol the tobacco budworm. EPA also pub-
lished notice In the FEDERAL REGISTER (43
FR 6228) of informal public hearings
with respect to Louisiana's application.
The hearings were subsequently held in
Baton Rouge, Louisiana, on February 27
and 28, 1975 and in Washington, D.C., on
March 3. 4 and 5, 1975.
. On March 12, 1975, EPA announced
revised procedures with respect to ap-
plications such as Louisiana's which in
substance seek modification of prior can-
cellation orders. These proc2dures are re-
quired by virtue of the fact that modifi-
cation of a final order without a formal
hearing would i undercut the statutory
scheme of FEPEA and prejudice the
rights of parties who participated in the
lengthy cancellation hearings. A more
detailed statement of the reasons for
adopting these procedures is set forth in
tae preamble to the Rules of Practice for
Applications Under sections 3 and 13 to
Modify Previous Cancellation or Suspen-
sion Orders which I signed on March 12,
.1975, and which I Incorporate by refer-
ence herein. Prior to the holding of In-
formal hearings on Louisiana's applica-
tion, a seven-man panel of EPA technical
and administrative experts was ap-
pointed to hear the testimony presented
at the hearings, review all 'exhibits sub-
mitted by the participants, and analyze
the statements submitted by all in-
terested parties which summarize the
evidence bearing on the Louisiana peti-
tion. This panel was also charged to re-
view the whole of the data, and make &•
assssssaeaJ as to whether
K®. 6Q=TOGS9AY,, APQft 0, 1973
-------
(!) "the applicant has presented sub-
stantial new evidence which may mate-
rially affect the prior cancellation or sus-
pension order and which was not avall=
able to the Administrator at the time he
made his final cancellation or suspension
determination and (2) such evidence
could not, through the exercise of due
diligence, have been discovered by the
parties to the cancellation or suspension
proceeding prior to the issuance o£ the
flnal order." (40 CFR 184.132(a)).
The report and conclusions of the panel
wera presented to me on Thursday,
March 13.1975. The panel concluded that
Louisiana had not presented any sub-
stantial new evidence which may mate-
rially affect the 1972 Cancellation Order.
The report and conclusions of the panel
•will be published in the FEDERAL REGISTER
along with the statement of reasons to
support of my order and determination.
Having reviewed and discussed the re-
port and conclusions of the panel I have
made a separate evaluation of the factors
involved in the Louisiana situation in-
cluding consultation with the EPA staff
and summary statements flled by the
parties to the informal hearings.
Because of the extraordinary time con-
straints, necessarily present in this case
and the need to announce my determina-
tion as soon as possible in order that
Louisiana farmers can proceed with
spring planting arrangements. I am an-
nouncing my determination today and
deferring publication of the complete
statement of the basis for my determina-
tion until next Monday, March 17, 1975.
The environmental impact resulting
from the amount of DDT projected for
the Louisiana application gives me cause
for great concern. Wo evidence was pre-
sented that would refute the finding ta
1972 that DDT is a mobile, persistent
compound that is uncontrollable in the
environment even when used hi accord-
ance with strict directions for use. Thus,
the use of several million pounds of DDT
in Louisiana will likely result in wide
scale environmental contamination. The
flndlng in 1972 that DDT poses a cancer
risk for man Is still true today. In fact
scientific experimental evidence gener-
ated since the June, 1972, decision tends
to reaffirm and augment this cancer haz-
ard. In addltien to the added risks to man
end wildlife, there are various commer-
cial fish, livestock and feed industries
likely to be affected economically by the
resulting residues. I could find no new
substantial evidence that might mate-
rially change the 1972 findings.
In addition, I could find'no new sub-
stantial evidence on the benefit side of
this use of DDT. The best available evi-
dence indicates that fluctuating -weather
conditions, national overpiantlng of cot-
ton, crop subsidy, price, and other eco-
nomic factors tend to have a greater ira~
pact on reduced cotton yields in Louisi-
ana than the tobacco budworm insect.
Alternative controls are available to
Louisiana farmers. Other pesticides—for
example. Galeeron, EPEJ,, and methyl
parathloB, coupled srith proper applies
tion timing—have been shown to be ef=.
fectlve and are expected to be available
In-sufficient quantity this year. Farmers
In the Brazos Valley of Texas and the
Arkansas Delta, have controlled budworm
problems without DDT. using integrated
pest management, such as "scouting,"
and by using alternative pesticides. Early
planting also appears to reduce the sus-
ceptibility of cotton to tobacco budworm
infestation.
The record further indicates that it is
feasible to plant alternative crops that
do not have similar insect problems and
which can produce valuable food and
feed products.
Accordingly, the section 18 application
by the State of Louisiana for emergency
use of rtoT on cotton in 1975 Is denied.
A more -detailed description of the rea-
sons for this order will follow on Monday.
March 17,1975.
Dated: March 14,1975.
HWSSELS. E. TRAm,
Administrator.
(FK Dac.73-8080 Filed 4-7-75:8:46 amj
[FKL 358-3J
STATE OF LOUSSJANA REQUEST FOR!
EMERSENCT USE OF DDT ON COTT0M
Supplemental! Statements of Reasons ffo?
Supplement to the Order and_ Deter-
mination, and Statement of Reasons for
the Order and Determination of the Ad-
ministrator that Reconsideration of the
Agency's Prior Order of Cancellation of
DDT for Use on Cotton is Not Warranted.
On June 30, 1972, former Administra-
tor. Huckelshaus cancelled virtually all
Federal registrations of DDT—Including
use on cotton. (37 FR 13369) (1972
Order). That 1972 Order was then af-
firmed by the U.S. Court of Appeals for
the District of Columbia. See DDT V,
Statement at 17-18. Since that time EPA
has received and denied approximately 44
separate requests to use DDT on cotton
on the basis that considering the gen-
eral human and environmental risks as-
sociated with such DDT use, the appli-
cants failed to establish sufficient new in-
formation to warrant approval of the re-
quest. Statement at 23. On January 24,
1975, the State of Louisiana applied for a
specific exemption under section 18 of the
Federal Insecticide, Fungicide, and Ro-
denticide Act, as amended (FIFRA) for
the application of 2.25 million pounds of
DDT to control the tobacco budworm on
approximately 450,000 acres of cotton.
By "Order and Determination" of March
U. 1975,1 denied the request. A full state-
ment of my reasons was set forth In my
50 page March 17, 1975, "Statement of
Reasons for the Order and Determination
of the Administrator that Reconsidera-
tion of the Agency's Prior Order of Can-
cellation of DDT for Use on Cotton is
Not Warranted" (Statement). That
Statement summarized the extensive
prior administrative and judicial deter-
minations relating to DDT. On March 21,
1975, the State of Louisiana and the U.S.
Department of Agriculture (USDA) peti-
tioned for reconsideration of my March
14. 1975, Order and my March 17, 1975,
Statement. These pettions alleged var-
ious grounds for reconsideration includ-
ing comments contained in a report given
on March 19, 1975. to the EPA Hazard-
ous Material Advisory Committee by an
Ad Hoc Study Group (Ad Hoc GroupK1 .
F1FRA section 18 provides that "the
Administrator may, in his discretion, ex-
empt any Federal or State agency from
any. provision of this Act if he deter-
mines that emergency conditions exist
which require such exemption " I have
determined that in cases such as Loui-
siana's—where pesticide use has been
Cancelled by final order after exhaustive
proceedings involving the same issues—
this discretionary power of exemption
should, only be exercised in accordance
with appropriate procedures! Such pro-
cedures are necessary in order (1) to as-
sure that public resources will not be
wasted.in repeated administrative liti-
gation of questions which will not ma-
terially affect the prior order and for
which an opportunity for thorough ad-
Judicatory hearings has already been
provided and (2) to provide that if sub-
stantial new evidence is presented which
may materially affect the prior order the
discretionary exemption power will not
be exercised so as to modify the prior
order without giving the parties to the
original proceeding an opportunity to
participate in a formal hearing on the
particular' questions presented. These
considerations led me to adopt modifi-
cations of the Rules of Practice which.
govern such EPA hearings. See 40 CFR
164.130 (40 FR 13281).
In the case of the Louisiana petition
the State has now had a. full opportunity
to present additional Information in 5
days of public hearings held solely for
that purpose. During the February and
March, 1975, hearings on the Louisiana
application 93 witnesses were heard, 1180
pages of transcript were generated and
more than 1080 pases of exhibits were
introduced.
After these additional hearings had
been completed, I reviewed the written
summary statements flled by the par-
ties, considered the conclusions of the
EPA seven-man panel (EPA Review
Panel) which heard the testimony and
held informal discussions with my staff
and with the Ad Hoc Group. I then con-
cluded that there was no substantial new
evidence which may materially affect the
1972 Order and I denied the petition.
1 The A
-------
Af tsr reconsidering the record la this
proceeding end the petitions for resoa-
slderaticn as well as the conclusions cf
the EPA Review Panel and the comments
of the Ad Hoc Gomp, I deny the re-
quested reconsideration and stats as
basis for my denial the following:
CAWCEQ BISK TO
Second, tfesra is no new evidence which.
First, there is no new evidence which
casts doubt on the 1972 findings that
continued use of DDT poses a cancer
risk to man. Post- 1972 laboratory studies
confirm the carcinogenic properties of
DDT. Administrator Ruckelshaus found
in 1972 that "there is no adequate human
epidemiological data on the careinosen-
icity of DDT, nor is it likely that it can
ba obtained." (37 FR 13375) . There are
no post-1972 human epidemiological
studies which disprove or contradict this
finding concerning the human cancer
risk of DDT. When we deal with cancer
we deal with a matter of grave concern.
The 1872 findings did not, of course,
conclude that DDT causes cancer in
man: the 1972 findings concluded that
DDT poses a cancer risk to man. Science
provided no conclusive answers in 1972,
and no such conclusive answers to the
human cancer risk are available today.
What remains, however, Is clear and un-
contested evidence of DDT"s ability to
induce cancer in laboratory animals. As
former Administrator Ruckelshaus con-
cluded in his 1972 DDT findings (37 PR
13375, IV, A, '9(c)), and as I recently
stated in my Order suspending registra-
tions of aldrin/dieldrin, given our un-
certainty about the precise mechanisms
that cause cancer and given the lack of
adequate epidemiological studies on such
ubiquitous environmental contaminants,
"I believe that a carcinogenic reaction in
any species of test animal must bs con-
sidered sufficient to describe the test
compound as a carcinogen and so a
threat to human health." (39 FR 37270) .
In the face of laboratory data demon-
strating carcinogenesis, regulatory de-
cisions which directly affect the public
health cannot be deferred — with con-
comitant irreversible human exposure —
pending completion of epidemiological
studies which require many years, are
often of questionable significance and in
any event provide date, for making public
health decisions only after the public
health may have been irreversibly
jeopardized.'
1 The only "evidence" submitted by Louisi-
ana or 0SDA (and referred to by tho Ad Hoc
Group) on tho human health Halts associated
with DDT use la on Aprtl. 1974, quotation
from on EPA official to the effect that: "There
Is, at the present tlmo, no evidence that
DDT Is carcinogenic (or tumorgenlc) in any
fmimtvi species when administered at levels
less than two orders of magnitude higher
than the maximum dose attainable by plant
manufacturers and workers over a lifetime
of exposure." I have consulted with the offi-
cial Involved and find that he estimated the
"maximum dose" of DDT plant workers to
bo approximately 0.2S7 mg/kg/day. Two
orders of magnitude higher than that would
be 23.7 mg/kg/day. These estimate ore de-
rived from Laws, et &1, 1937. At too tlmo
tinued use of DDT poses serious risks to
fish "ad wildlife. None of the participants
in too recenfc hearings on Louisiana's
petition, presented evidence contesting
tha basic environmental findings of
former Administrator Ruckelshaus. In
the 1972 Order he found that "once dis-
persed, DDT is an uncontrollable, durable
chemical that persists us the aquatic and
terrestrial environments." 1972 Order, 37
FJB. 13370. He concluded that DDT was
"highly volatile" (37 FR 13370 n. 16) and
"can vaporizs from crops and soils" (37
FR at 13375); that it "can be trans-*
ported by drift during aerial application"
(Id. at n, A, 3 (a)); and that it "can be
attached to eroding soil particles" (Id. at
2Z, A, J (c)) dsrinistrafcor Ruckelshaus
also found tha*-. DDT "can persist 'Q the
soils for yea*. ~nd even decades' (Id.
at n. A, 1); tha« it "can persist in aquatic
ecosystems" (Id. at n. A, 2); and that "it
is occasionally found in remote areas or
in ocean species, such as whales, far from
any knowm area of application" (37 FR
at 13370-71). As a result of its persistence
and mobility, he found that DDT is "con-
centrated in organisms and transferred
through food webs" (37 FR, 13375); that
DDT "accumulation in the food chain
and crop residues results in human ex-
posure"; (Id. at m. A, 2); and that "hu-
man beings store DDT" in their tissues
(Id. at ttl, A, 3). -
These inherent characteristics of DDT
are particularly important In view of the
uncontestsd findings of Administrator
Ruckelshaus that the 1972 evidence
of tho 1973 Order tho lowest dosage which
had produced tumors In laboratory animate
weo 37.8 mg/kg/day (250 p.pjn.). Accord-
ingly, co of 1973, tumor Induction hod not
been confirmed in laboratory rsnlirvM^ at
feeding levels lower than & lovol two orders
of magnitude higher than estimated maxi-
mum plant worker intake. (MMrimmn la-
takes estimated according to Ortoleo, 1968,
wero 0.57 mg/kg/day and two orders of mag-
nitude greater than that would bo 57
mg/kg/day.) Thlo comparison Is Interesting,
bu« doss no4 cent doubt oa tho 1973 finding
of cancer risk to man. Moreover, the EPA
official In question had not, at the time of his
otatament. had an opportunity to review
posS-1972 DDT carcinogenic laboratory
studies. These studies indicate DDT tumor
induction In laboratory animals at feeding
levels ES low cs 0.3 mg/kg/day (2 p.pjn.)
(sea Statement at 32-33), a level comparable
to Low's estimated minimum Intake of plant
workers (0.287 mg/kg/day) and substantially
lower than Orteleo's estimated maximum
worker Intake (0.57 mg/kg/day).
The Louisiana petition also refers to &
November 28, 127<1, letter of Dr. Lloyd Tepper.
That letter summarized various DDT cancer
data, but did not undercut the 1973 finding
of the human cancer risk posed by DDT.
The pre-1972 data referred to by Dr. Teppor
hcd bean coosidored in tho 1972 Order. The
post-1972 data referred to by Dr. Tepper
confirm tho carclnogoncsis of DDT in the
laboratory mouso and tho positive correla-
tion between such a finding and breeder
carcinogenic effects In other species.
"compsllingly demonstrates the adverse
impact of DDT on fish and blrdlife." 1972
Order, 37 FR 13371. No new evidence has
been introduced and none has been cited
by XJSDA or Louisiana which undercuts
this prior finding.
Moreover, no evidence has been offered
by Louisiana or USDA to contest the
specific 1972 findings of adverse environ-
mental effect:
1. DDT affects phytoplankton species'
composition and the natural balance In
aquatic ecosystems.
2. DDT is lethd to many beneficial agricul-
tural Insects.
3. DDT can have lethal and • sublethal
effects on useful aquatic freshwater Inverte-
brates, including arthropods and molluscs.
4. DDT is tonic to ash.
5. DDT con cfiect the reproductive success
of fish.
6. DDT can have a variety of sublethal
physiological and behavioral effects on ash.
7. Birds can mobilize lethal amounts of
DDT residues.
8. DDT con causa thinnings of bird egg-
shells and thus Impair reproductive success.
(1972 Order. 37 PR 13371 at IV, A. 1-9).
Not only Is there no new evidence
which would reduce the environmental
hazards previously found, but Louisiana's
application for use of DDT candidly
states that: "The undesirable features of
once more applying DDT to large areas
of cropland are recognized." Louisiana
Application at 5. Many of these undesir-
able features have been recited In Loui-
siana's application which contains a brief
statement of the Louisiana, Wildlife &
Fisheries Commission. Because it was
formally adopted by the Commission
with respect to the State's requested DDT
use and because it shows the applicability
of many of the general environmental
hazards of DDT to the specific environ-
ment of Louisiana and surrounding areas,
I flnd it appropriate to quote the entire
statement as follows:
STATEMENT BY THE LOOTSIANA WILDLOTJ AND
FisunnTOi COMMISSION on EFFECTS or DDT
OW WrLDLETB
The EPA will bo petitioned to life the ban
against DDT for the control of tho tobacco
budworm and the pink boll worm in cotton
during the 1973 growing season. The Louisi-
ana Wildlife and Fisheries Commission has
been- asked to comment on the impact of
this insecticide on ash and wildlife.
There is documented evidence that DDT
(metabolites), which is one of the chlorinated
hydrocarbons, is very persistent in the en-
vironment and has been detected in high
_ concentrations In fish, birds and mammals.
Actual damage has occurred in the form of
direct mortality, reproductive failure, and
behavioral changes. DDT Is acutely toxic to
fish, shrimp, crabs, less tome to birds and
mammals. DDT applied on lend areas through
natural drainage will find its way into the
marine environment along the Louisiana
Coast. Examples of damage are listed below:
I. Mortality of Penaeld (Brown & White)
Shrimp l occurs at 0.15 ppb (parts per bil-
lion)- and bloassays conducted in Mississippi
indicate 50 percent of the freshwater
shrimp » tested over 34 hours and in four
1 American Fisheries Society, Volume 101,
No. 3.1973, Nlmmo. D. R.
"Amortcan Fisheries Society, Volume. 99,
No. 4, 1970, Page 693. Fugerson, Denzel.
Q2E-JSTG2, Vet,
0,
-------
116
••*$%
•..*$3
<3igE?esifc SccGtioas aero Silled at tho follow-
ing concaatenttons: 2.S ppb, QJ3 ppb, S.7 ppb.
EL DDT* lo tosie to fish." tillllng aolf tho
goOatrlng flsh exposod 90 hours at concon-
teattonc of: Bullheads, B ppb: Goldfish. 2i
3>pb; mnno'OT, IB ppb; Corp, 10 ppb; BJuo-=
EUt, 8 ps>5>: Bees, 2 ppb. .
Otho? bloaesay reports indicate a 96 hour
tliffi 60 cm blueglUs ranging from 7 to 18 ppb.
£EL DST causes thinning of egg shells and
concTqueat critical reduction In hatching
cucceoo of polleans,4 sea gulls, woodcock and
various raptors. Direct mortality to pelicans
has been attributed to DDT on birds ob-
tained from Florida and held at the RockQ-
fcdte Refuge.
XV. Robert L. Rudd states in his boob
"PeatJcldes of the Living Landscape", that
Bdf of tho reptiles and amphibians are killed
•v7&cro DDT lo used at the rate of 1 pound
that environmental contamina-
tion resulting from the aerial and ground
sjjBJlicBtiost c£ 2.25 million pounds in.
Louisiana will not be confined to Loui-
siana. (See also Statement by the Loui-
siana Wildlife & Fisheries Commission
on Affects of DDT on Wildlife at second
7. Toslclty of Crawfish — half were billed
when ospoaed to O.a ppm over 24 hour period.
High DDT residues found In fish resulted
in tho drains of Mossy and Wolf Lakes IB
Mississippi to commercial ashing and a warn-
ing to the public against eating excessive
omounto of the ashes from these lakes, effec-
tive July 8. 1971.
Completion Report F-83-2. 1970, "A Moni-
toring of Pesticide Levels and Water Quality
of the Major Drainage Ditches Entering Wolf
Lui£e, Mcresy LO&Q and Broad Leke,w RSSsols-
slppl Gomo end Fish Commission, Cotton
and Hairing.
The significance in thin action Is that di-
rect economic losses have been Incurred as
o result of DDT residues effecting the mar-
tetabttlty of commercial Ssh. The woodcock
season in New Brunswick was recently closed.
Tho stated reason being high concentrations
of DDT in muscle tissues of t&ese birds. This
is a direct recreational loas.
Adopted: January 13, 1978, by tho Loul-
olaao wildlife and Fisheries Commission,
See Louisiana Application c£ 63-93.
The Ad Hoc Group reported that it also
believed that the 1972 fladlngs of the en-
vironmental hazards of DDT are appli-
cable to the requested use of 2.25 million
pounds in Louisiana this year. Ad Hoc
Group at 4.
The Ad Hoc Group concluded, how-
ever. that "The environmental r&mifica°
tions appear to be limited to Louisiana."
Id. at 5. In support of this conclusion the
Group stated that the "area to be treated
la over 100 miles north of the Gulf of
Mexico ° ° °,M that "aH drainage ways
(for the treated area] end ap In the
Atchafalaya Hive? and Atchafalaya
Bay ° ° ° " and that none of the areas
in question "drain into the Mississippi.0
Id. I reject this conclusion of the Ad Hoc
Group. Given the volatility of DDT, its
demonstrated ability to drift during
aerial application and Its ability to move
with eroding soil particles,0 I am con-
"American Fisheries Society 1970, Volume
88. No. 1, Page 20. Mocelr, Kenneth J.
""Relations of the Brown Pelican to Ce?=
tain Environmental Pollut&nta in Louisiana.",,
•Joonen, Ted.
"American Fisheries Society X983, ^olumo
83. Xo.
-------
117
and a shift to alternative crops. Ea
laiana, this cutback Itself Is likely to cufi~
weigh all other factors In terms of eco-
nomic Impact on cotton produces and
related service Industries and thus oss
the State's economy as a whole.
The EPA Review Panel thoroughly ex-
amined all of the evidence presented dur-
ing the recent 5-day hearings. I adopted
the report of -the EPA Review Panel in
my March 17 Statement. My discussion
In the March 17 Statement sets forth
the basis for my March 14 Order. In
short, although Louisiana and other par-
ties have had ample opportunity to do
so, they have presented no substantial
evidence—new or old—to support, the
premises that the tobacco budworm prob-
lem Is new, that recognition of its oc-
currence and seriousness is new, or that
the DDT mixture is the only insecticide
that can be expected to prevent eco-
nomically significant damage arising
from a possible tobacco. budworm out-
break this year.
Louisiana and USDA now assert that
I should reconsider my decision as a re-
sult of the comments of the Ad Hoc
Group. The Group stated that "one could
not, in 1972, anticipate the rapid in-
crease in- resistance to methyl para'thion
by the tobacco budworm nor the rapid
geographical spread of resistance." Ad
Hoc Group at 2.
To accept this statement, one would
have to ignore several Important factors.
By 1970 near total resistance to methyl
parathion and all other chemicals com-
monly used for control of the tobacco
budworm had already developed in the
Tampico and Matamoros areas of Mexico
and in the Lower Rio Grande area of
Texas as a result of massive use of this
and other compounds and resulting se-
lective pressure on tobacco budworm
populations. This shift from Insecticide
susceptibility to resistance could have
been anticipated whenever chemicals
were being used intensively over a large
area.
In fact, Louisiana appears to have
anticipated such resistance. The testi-
mony of Dr. James Tynes, Louisiana Co-
operative Extensive Service, in the recent
hearings on the Louisiana application
noted that. In May and June 1971, he had
called attention to the problem of to-
bacco btxdwm resistance to methyl
pms&iion and its implications for cot-
ton production In Louisiana. In addition,
to s published (Hay 1971) article he in-
troduced into the record. Dr. Tynes had
noted that tobacco budworm resistance
to meu yl parathion had been associated
with difficulty In controlling an infesta-
tion in at least one location in Louisiana
back In 1970. It seems apparent that the
Ad Hoc Group was not aware of this
testimony.
The Ad Hoc Group's 3tatement that
the DDT-toxaphene combination is
"known to exhibit a synerglstic effect of
up to twenty-fold against moderately
DDT resistant populations" is totally ir-
relevant to the question of the efficacy
of DDT-toxaphene. It is true that com-
bining DDT and toxaphene results in a
synergistlc effect against the tobacco
budwr'— as or-ip:..ed to DDT alone.4
This comparison begs the question since
the application .««?eks the use of the x2i. T-
toxaphene mixtiL and since Louisiana's
own data indicate that tobacco budworm
resistance to the DDT-toxaphene mix-
ture was seven-fold or greater at seven
of twelve Louisiana sites sampled In
1972-74. With such tobacco budwonn
resistance levels the DDT-toxaphene mix
has been shown to be ineffective for con-
trol of this insect.
The Ad Hoc Group also stated that
"under high population pressures the re-
quested mixture offers the best chance of
successful pest management for 1975."
After hearing all the evidence in the 5-
day hearings and reviewing all exhibits.
together with the written statements and
public comments, the EPA Review Panel
concluded that there was no substantial
new evidence to support such a proposi-
tion. In my March 17 Statement Z
adopted the report and conclusions of
the EPA Review Panel. ! find no addi-
tional evidence in the Ad Hoc Group
statement and accordingly find no basis
to change my prior decision,
« « • • •
In conclusion, after reconsidering the
record in this proceeding I reaffirm my
March 14 Order in which I denied the
Louisiana application for authorization
to use 2.25 million pounds of DDT on
450,000 acres of cotton this rear. I rest
my reafflnnatlon of the prior denial on
this Supplement and on my March 14
Order and my March 17 Statement.
which I specifically adopt and incor-
porate herein by reference. There re-
mains no substantial new evidence
which may materially affect the 1972
Order with respect to the human cancer
risk posed by DDT, the environmental
hazards of DDT and the need to use DDT
on cotton.
Dated: April 1.1975.
RUSSELL E. TRAIN.
Administrator.
[PR Doc.75-9081 Filed 4-7-75:8:45 am)
'The bosls for this statement apparently
cornea from data published by Graves,
Glower, and Bradley (1987, Resistance of the
Tobacco Budworm to Several Insecticides In
Louisiana) which compared the LDSO for
tobacco budworms. exposed to several In-
secticides, collected near Transylvania, Loui-
siana, in 1966. In this test the LDSO for DDT
WES approximately 30 times greater than the
combination tosaphene-DDT (2:1).
P3S2BM 02@8S?22,
68— YU2S8AY, APQI8, fl. 1973
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118
APPENDIX E
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119
THURSDAY, JULY 3, 1975
WASHINGTON, D.C.
Volume 40 H Number 129
PART 11
WIRONMENTAL
PROTECTION
PESTICIDE PROGRAMS
Registration, Registration and
Classification Procedures
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120
Tttt* 40—Protection of Environment
CHAPTER I—ENVIRONMENTAL
PROTECTION AGENCY
SUBCHAPTER .6—PESTICIDE PROGRAMS •
[PHI. 383-41 ' ' ' -'. -
PART 162—REGULATIONS FOR THE EN-
FORCEMENT OF THE FEDERAL INSEC-
TICIDE. FUNGICIDE. AND RODENTICIDE
ACT ."- ..;«••; ,;\
Subpart A—Registration, Reregistratioit
and aassifieatfon Procedures ~ .
On October 16, 1974, notice was'pub-
lished, in the FEDERAL REGISTER (39 FR
36973)' proposing regulations- to amend
40 CPR 162 pursuant to the authority
of sections 3 and 25 of the Federal In-
secticide, Fungicide and Rodentlclde Act.
.(FIFRA), as amended', by .the Federal
Environmental Pesticide Control Act
(FEPCA). Pub. L. 92-516, 88 Stat 973,
hereinafter referred to as amended
FIFRA. The regulations shall read as
set forth below.-The Intent of this rule-
making is to revise present procedures'
for the registration, of" pesticides and
establish procedures for the rereglstra-
tlon and classification of pesticides to
conform to the provisions of the amende
ed FIFRA. . •..-'.'. ,;" ...'
- Throughout the development of these
regulations, the Agency lias taken every
opportunity to solicit public views, and'
comments. Beginning with the January
9, 1973, FEDEHAL REGISTER notice (38 FR
1142)-, the Agency stated that public
comments on the form and content of
the regulations were Invited. Moreover,
the Agency in the January 9,1973 notice-
set forljh Its "preliminary views" on
the regulations. Including registration.
Shortly thereafter, the 'Agency -held a
number of informal public hearings on
the classification and registration, pro-
visions under the amended FIFRA. Each
of the views' and comments received at
these.hearings was then considered in
the. development of an initial draft regu-
lation. , , :_,•;..•"••_, Xx-
As> the numerous draft proposals were
developed by the Agency, they were made
available to all Interested parties. Com-
ments on the drafts.were received from
State regulatory agencies, industry, trade
associations, environmental groups, other
Federal agencies,' and Individual Con-
gressmen. Further, representatives of
the Office of Pesticide Programs discussed
at length various proposals with repre-
sentatives from each of these, groups.
The comments received were considered
.In evaluating the merits of each of the
drafts and- modifications ' were- made
where appropriate. ' .
In July, 1974, following distribution
of over 2,000 copies of the complete draft
regulation the Agency held an Informal
public hearing In Washington, D.C. At
this hearing, representatives of the
Agency explained hi detail the major
provisions of the draft regulation and
the rationale behind each provision. At-
tendees made formal statements, sub-
mitted written comments and raised
specific questions on the draft which-the
officials of EPA addressed: a transcript
of the hearing was taken. After consider-
ation of the views expressed at the pub-
. . RULES AND REGULATIONS
' <• '"''"'"',• "''••;• ' ' '
lie hearing, the proposed regulations
'•were published in the FEDERAL: REGISTER
'for formal public comment.
" Many Interested parties complained
that the comment period on the proposed
regulations was- too short. After- con-
sideration.- of these complaints, the
Agency. notified all interested parties..
that comments on the regulations would
be received and. considered during the
period of preparation of the final regu-
lations. Numerous comments were in fact
received, and...considered during the
several months preceding issuance of
these regulations. In addition, during this
same period the Agency, held information
meetings, on request, with as many In-
terested parties as possible to explain the
. proposed .regulations and modifications-
under consideration. As a result, writ-
ten comments on the proposed regula-
tions were received from over 200 inter- •
ested parties. All of these comments have
•been Reviewed and are on\file with/ the-
Agency* Certain of these comments, have.
been, adopted and others were substan-
tially satisfied by editorial changes, de-
letions from.or additions to the regula-
tions. • •;"•.; -,. - ^ •
"Finally, on a. number of. occasions,
certain parties, representative Industry
groups in particular, have, complained
that they could not fully comment on
the Section 3 regulations without having
the Guidelines relating to data submis-
sions available at the? same time. These
contentions are rejected for the following
reasons.- First, beginning as early as
January, 1972, drafts of. the Guidelines
have been made available to all inter-
ested' parties. The pesticide Industry,
through Its; representatives; has not only'
had an opportunity to comment on these
various drafts over the last'two years
but has been Involved in reviewing' and'
assessing-comments and In suggesting
' modifications. Second, the regulations
establish data and . evaluation criteria •
Which are self-contained. Informed com-
ments as to the" regulations, then, did
not depend on whether or not the Guide-
lines for testing and data development
were published in the FEDERAL REGISTER-
for formal public comment at the same
time as these regulations were so pub-
lished. For these reasons. It Is believed
that'all affected parties have had a full
and' fait opportunity to comment • on.
these regulations. ,. ..
. ' : -•;. GENERAL; ..'""'
' - . -. • •' - ' -. • . s
Passage of the 1972 amendments' to'
FIFRA enacted through the Federal En-
vironmental Pesticide Control. Act1
' (FEPCA> was part of a wave of environ-
mental legislation "which, completely
overhauled Federal environmental regu-
latory authority. In ' 1970, Congress
passed the Clean Air Act* and In 1972,
along with the amendments to FIFRA,
Congress enacted substantial amend-
ments to the Federal Water-Pollution
Control Act,* ' . ./
While Federal regulation- of pesticides.
first began in 1910 and was substantially
expanded in 1947,' the 1972 amendments
completely restructured . the Federal
pesticide regulatory scheme, and rede-
fined Its thrust: FIFRA was changed
"from a labeling law Into a comprehen-
sive regulatory statute that will hence-
forth, more carefully control the manu-
facture, distribution; and use of pesti-
cides.'" As'the House Committee on
Agriculture summarized in Its Committee
Report: . ' __—-_• . .•
. The Committee found the greatest need
for revision of existing laws to' be In the
areas of. strengthening regulatory controls
on the uses'and users of pesticides, speeding
up procedures for barring pesticides found
to be undesirable; streamlining procedures
for' making -valuable.'new measures, pro-
cedures, and materials broadly available;
strengthening enforcement procedures to
protect against misuse of these biologically
effective materials; and creating an adminis-
trative and legal framework under which
continued research can produce more knowl-
edge about better ways- to use existing pesti-
cides as well as developing alternative ma-
terlaJa-and methods-of pest control.*
It is clear that Congress' primary- pur-"
pose in enacting FEPCA was to, ensure
that pesticide use wa£ subject to a
thorough environmental and' human
health hazard review/ . _ '
- In keeping with this environmental
and . human health -perspective, the
amended FIFRA established many new
. requirements for review In connection
wjth the registration process. This pre-
amble discusses the new requirements,
their implementation by these regula-
tions and the Agency's responses to com-
ments^ received on the proposed regula-
tions. _ .,_ - •
- • COMMENTS AND REVISIONS
: Section 162.2 Principal Statutory Pro-
visions. Several commenters suggested
that this entire section be deleted or that
it track the statute verbatim. The prin-
cipal 'statutory provisions of FIFRA rele-
vant to the registration, reregistration
an* classification of -pesticides are de-
scribed hi the regulations for the con-
venience of the reader who may not have
a copy of FIFRA on hand. In response
' to the comments,- several modifications
have been made in the text to track the
statute more closely. We reiterate, how-
ever, that any specific question of statu-
tory interpretation must necessarily be
186 Stat. 978, Pub. L. 92-816, 7 TJ.S.O.136.
'• Clean Air Amendments of 1970, 84 Stat.
1976*Pnb. L. 91-604,42 UJS.C. 1857.
•Water Pollution Control Amendments.of
1973, 86, Stat. 816, Pub. L. 92-600, 33 tTJS.C.
1251. ... . - -
« The Insecticide Act of 1910 prohibited the
Interstate sale of any Insecticide or fungicide
which was adulterated or misbranded; how-
ever; the Act did not require registration of
pesticides. The concern of the 1910 Act was
the effectiveness of products and deceptive
labeling. The 1947 FTFRA established a regis-
tration requirement, but authority to deny
.registration applications was not provided
until 1964. As with .the 1910 Act, the 1947
PTPRA's primary purpose was the protection
.of consumers from Ineffective products. See
Steams Electric Paste Co. v. Emkronmental
Protection Agency, 461. F. 2d 293 (7th Clr.
1972). , ...
•SLR. BEP-. No: 92-111; 92 Cong, 1 Sess. 4
(1971). - .: .
• House Report, -at 4.
T House Report, at 13, 20 and Senate Re-
port, at. 5. '
; FEDERAL REGISTER, VOL 40, NO. 129—THURSDAY, JULY 3, 1975
-------
AND REGULATIONS
based on Jb'Ir'RA.- as Amended, the pro-
visions of the substantive regulations im-
plementing it, and any judicial interpre-
tation thereof.
- Section 162.3 Definitions: Several com-
-menters indicated that It is unnecessary
to repeat in the regulations a definition
contained la rjLfr'KA. Those definitions
which appear in FTPRA and are repeated
in the regulations are either essential
to-the understanding of these regulations
or have been given further interpreta-
•tion by these regulations.
(1) Section 162.3(3) Accident, Several
commenters suggested that the Word "un-
reasonable" be added to the definition of
this term to indicate the extent of the
adverse effect upon man or the environ-
ment. These commenters misunderstand
the statutory scheme of FIFRA, as
amended. A finding of unreasonable ad-
verse-effect on the environment from use
of a pesticide is grounds for the cancel-
lation or the denial of the registration
of a pesticide. The occurrence of an ac-
cident- alone may or may not establish
that a pesticide causes an unreasonable
adverse effect on man or the environ-
ment. Such a, determination is made
after a full review and evaluation of the
evidence in each case. Where the effects
from_nse o£. a. pesticide are found, to be-
unreasonable, appropriate actions-will bs
taken by the Agency.
(2) Section 162.3 (c) Active Ingredient.
(a) Several commenters asked that the
word "attract" be deleted from § 162.3 (c)
(1). They argued that it is not included
within the statutory definition of "ac-
tive Ingredient", and furthermore that
the Agency has Included several attract-
ants .as examples In its definition of Inert
ingredient. § 162.3(t). Amended PIFRA,:
at section 2 (a) (1), defines active ingre-
dient, in part, as an ingredient which
will prevent, destroy, repel or mitigate
any pest. Where an ingredient falls with-
in this broad statutory standard, it will
be evaluated as an active ingredient. The
definition of "attractant", • within the
larger definition of "pesticide" at § 162.3"
(ff> (3), indicates which attractants are
active ingredients and which are inert
ingredients. In addition, the reader is
referred to the definition of inert ingre-
dient at § 162.3(t) and the factors, listed
at § 162.6(b)(2)(i)(C)(2), used by the
Agency to determine whether an Ingredi-
ent is active or inert To avoid the ap-
parent confusion caused by inclusion of
the word "attract" at § 162.3(c) (1), it
has been, deleted.
(b) In response to comment, and in
order to clarify the term active ingredi-
ent, in the case of a plant regulator, "bio- -
chemical" has been added to the defini-
tion at § 162.3(c) (2).
Sectioa 162.3(c)(2), as proposed,
has been transposed to § 162.6(b) (2) (i)
(C) (2).
(3) Section 162.3(j) Application of a,
Pesticide. In order to clarify that the
Agency includes placement for effect of
a pesticide within the meaning of "appli-
cation of a pesticide", this term has been
defined. The Agency feels that the defi-
nition of the term "direct application" Is
redundant and accordingly has deleted
§ 162.3(1). as proposed.
(4) Section 162.3 (t) Changed Use Pat-
tern. Questions arose' concerning the
indices the Agency will evaluate in de-
termining whether a new use is a
changed use pattern. The distinction be-
comes important in the notice provisions
of section 3(c) (4) of the Act and the reg-
ulations therernder. To clarify the Agen-
cy's" interpretation of a changed use
pattern, the term has been defined as a
significant change frctfl a use pattern
approved in connection with the regis-
tration of a pesticide product. Examples .
of "significant" changes are included in
the definition. Deletion of a significant
use pattern is also included within the
scope of this term so as to provide user
groups with .notice of these-regulatory
actions..
a: rjcticr az..-esr-
rodation Product. The Agency inter-is to
include within *** meaning of "degi-ida-
tion product" a .substance resulting from
any transformation of a pesticide. For
greater clarity the definition has been
modified to read: "by physico-chemical
or biochemical means." "Electromag-
netic" has been deleted, pursuant to
comment, to avoid redundancy..
(6) Section. 162.3(ls), proposed. De~
'layed Reaction. Several commenters ob-
jected that this term, as defined in the
proposed regulations, was too specific
and out of context compared with the
other definitions, of toxicity. After con-
sidering the matter, the Agency has con-
cluded that the term is self-explanatory
and should, therefore, be .deleted.-
. (7) Section 162.3(m) [5162.3(1)1.
Domestic Application, (aV Several comr
menters correctly pointed out that the
definition of -"domestic application" as
proposed included only application of a
pesticide in. on, or around areas asso-
ciated with the household or homelife
and excluded-use of a pesticide in many
places where people are present for pro-
longed periods of time. They urged the
addition to the category of domestic ap--
plication of the use of a pesticide in a
wide range of institutions including res-
taurants, hospitals, nursing homes, parks,
playgrounds, schools, and office buildings.
The rationale for distinguishing do-
mestic application from .non-domestic
application is based on an evaluation of
risk taking into account the degree of
competence of the user, the susceptibility
of people likely to be exposed, and the
potential for accidental exposure to in-
dividuals other than the user. In certain
situations, these factors clearly deter-
mine into which of the two classes of
application a use falls. For example, use
of a pesticide in a home is a domestic
0 Where section numbers have been changed
between the proposed regulations and these
final regulations, the Preamble refers to the
section as designated In the anal regulations.
For the benefit of the reader, the Section
number which appeared In the regulations as
proposed follows Immediately after the final
Section number In brackets, [...], as appro-
priate.
application/ while use in a factory or
commercial institution is a non-domestic
application. In other situations, however,
the Agency must carefully weigh the fac-
tors to determine whether the use should
be considered a domestic application and
thereby be subject to the more restrictive
classification criteria. Pesticides intended -
for application in patient care areas o£
health related institutions and institu-
tions where children spend time are con-
sidered by the Agency to represent, on
balance, a higher risk to the exposed pop-
ulation. Even: though the user is likely to
be competent in the use of pesticides,
population groups of particular suscepti-
bility are present in these institutions.
These groups include the aged, infirmed.
and young. Accordingly, these institu-
tions have been added to the general.
scope of the term "domestic application"
and new subparagraphs (3) and?4) have
been included to give examples of the
specific types of institutions the Agency
considers within the scope of the term.
The suggestion that use of a pesticide
in a restaurant or office building be con-
sidered a domestic^ application has been
rejected. Not only is the user of the pesti-
cide in these locations likely to be com-
petent in the use of pesticides; but, more-
over, population groups of particular sus- .
ceptibility are not likely to be present for
prolonged periods-of time, and therefore,
there is no reason to expect a higher in-
cidence of accidental exposure to third
parties. Adequate margins of safety exist
in use of pesticides in these locations-
and therefore these uses are'considered
non-domestic.
(b) Several commenters suggested that
the term "non-domestic application" be
defined. Domestic application is defined
in detail in the regulations. If a pesticide
;use does not fall within this definition,
by the very terms of the definition, it
will be a non-domestic application. The
Agency feels that definition of the term
"non-domestic application" would be re-
dundant.
• (8) Section 162.3(n) [§ 162.3(m>},
-Drift. In response to-comment, the word
"immediately" has been Inserted to quali-
fy "after application" and clarify the
confusion over the definition, as pro-
posed.The Agency does not consider the
processes of diffusion and volatilization
to be included within the term drift.
(9) Section 162.3(r) [§ 162.3(q>], Haz-
ard. As with § 162.3fa), accident, several
commenters asked that the word "unrea-
sonable" be added to this definition to in-
dicate the extent of the adverse effect on
man or the environment. For the same
reasons as explained above, in the discus-
sion of § 162.3(a), such a modification is
unacceptable. Upon the finding of haz-
ard, there must be a separate determina-
tion of whether the hazard constitutes an
unreasonable adverse effect on man or
theenvironment.
(10) Section 162.3(s) Immediate Con-
tainer. A new definition of the term "im-
mediate container" has been added to
clarify the labeling requirements of
5 162.10.
(11) Section 162.3(w) f§162.3(u)]
"Metabolite. Several commenters Icdi-
FEDEHAl RECISTEa, VOL. 40, NO. 129—THURSDAY, JUIY 3, 1975
-------
122
csfead that the definition- of metabolite as
. proposed was technically incorrect. They
urged that "or induced by" be deleted be-
csissa metabolites are not "induced by"
living organisms or by biological proe-
esses. The Agency- is in.accord and has
• deleted the same. - • - ' -•.
(12) Section 182.3(y) [§ 182.3(w>1 Wu- '
iegetiie. Several ccffimehters'-jsuggeafcsd'-
"fihaS'the definition of this termVas Inac-
curate. Zt had been defined to mean "the-
propeFty of e substance or mixture of
aubatsneea to indues-genetic or soEiatic>.
changes to subsequent generations:" The
Agency agrees and the language of this
definition has been changed to read:
"changes in the genetic complement cS
'either somatic or germinal tissue in sub-
sequent generations." . - ^ ' '•
(13). Section 182.3(bb) [§162:3(z>]
Oncogenic. Many commenters objected -to
the use of th£ term "oneogenic," request
ing that it be replaced by term "carcino-
genic." An o'ncogenic-effect-includes-. in-~-
duettos of benign or .malignant tumors.
The commenters argued that-this dis-
tinction should be maintained for regula-
tory purposes. SPA has determined' that-'
the once significant distinction between
benign and malignant tumors has .lost
much of its validity! The federaTcourt in
its review of the Agency order suspend-
ing most uses of'pesticide products con-i
taining aldrin and dieldrte recently up-
held this determination as reasonable
and within the discretion of the Admin-
istrator. EDF v. SPA, 510 P. 2d 1292. 1300
•n 21 (D.C. Cir., 1975). EPA, therefore, re-
jects the proposal that this term be de-
leted. Several modifications to the pro-
posed definition however, have been made
for greater deification. The phrase "in-
due® benign or malignant tones forma- •
tions" has been added to clarify that the..
Ageasy indeed considers both, .to bs-
)-Section. 182.3(ceX t§182.3(sa)]
- Outdoor Application. Several commenters
asked that the term "indoor application"
be defined in addition to the term "out-
door application." The term "indoor ap-'
plication"1 is not explicitly used in these,
regulations. Each pesticide use win bs
evaluated to determine if it is an outdoor
. application. If it is, additional criteria
' must bs evaluated - in determining the
appropriate use classification. If a pesti-
cide use is not' an outdoor application,
the indicators for-' domestic or non-
domestic application, as appropriate,
alone will be evaluated to determine the
appropriate use classification:
US) Section 162.3 (dd) Operated by the
same Pro&iicer. Many commentsrs sug-
gested revision of § 182,5(b) (1) C8 162.5
(a) ] which sets forth the statutory ex-
emption from the registration require-
ment for pesticides transferred between
establishments operated by the same pro-
ducer solely for packaging at the second
establishment or for use as e> constituent
part of another pesticide produced at the
second establishment, in order to clarify
~ the Agency's interpretation of. the term
"operated by the same producer," fliis
phrase-has. been defined.. The reader is
referred to fe&ie discussion of Section 162.5
(b) (X) below for a full explanation of
that Section. •
.-(IS) Section "I62:3(ff) [8182.3(ceM
..Pesticide: (a) Many commenters asked
.that the word "attracting!' and the class
of pssticifle, "attesctant" be deleted from
~i J82.3(ff). They argued that "attract-
ins" is-not included within the statutory
defiaftton of pesticide. That definition
reads to pasi: "any substance or mixture
. of substances; intended for preventing,
destroying, repelltag or mitigating" any .
pest." The Agency agrees that "attract-
ing" doss not per sgnconstitute pesticidal
activity and accordingly the word has
been deleted from the first paragraph of
§182.3(ff). |t .doss-not follow, however,
that an attraetant is hot a class of pes-^
ticide; The Agency .takes s broad: view.
of th6 definition of. pesticide. Where $
substance OE- mixture of, substances is
intended to prevent, destroy, repel or
mitigate-aoy pest, ifc-is a pesticide. If an
attraetant. falls, within this statutory
"standard, it is a pesticide. Accordingly,
"attractant" hss been retained as a class"
'of pesticide^ Section 182.3(2) (3) gives
examples of .substances which are and
which are not considered attractsnts, for
"the purposes of the Act
.. (b) The proposed regulations, at
§§162.3(2) (I)-and (4) had declared cer-'
tain devices-subject to the'Act, pursuant
to the authority conferred upon the Ad°
ministrator at-section 25(c) (4) of FXFBA,
as amended. ~& commenter correctly
pointed" out that other- classes of devices
' should b© regulated. Accordingly for pur-
poses'-of clarity and thoroughness, a new'
\ §132.15 has been added- to these regula-
tions. I3ie reference to devices in § 182.&
.- (2) (1) and (4) has been deleted.-, .The
reader is-seferred- to § 182:15 and its ex-
planation be.low. . \ -'...': ...
(c) Severe! commenters raised ques-..
tions-concerning the wording of the de°
~flnition of "pesticide". It has been sub-
stantially rewritten for. greater clarity
and. thoroughness (1) to provide more
exact usage of the terms "preventing, de-
stroying, repelling or-mitigating"; (2) to
'set forth- with specificity those classes of
pesticides we have evaluated: (3) to clar-
ify that use- of the unmodified term
"pesticide" encompasses the active ingre-
dieritt pesticide formulation, and pesticide
' product; and. (4) to "clarify that the use
for pesticidal purposes of. biological-type
and. biologically-derived substances falls
within the scope' of the Act. Tnere has
tion of the term "pesticide".
(17) Sectioa 182J(hh) [g 162.3(cc)3
Pesticide. Pro&wst. Several oommenters
argued that the phrass "commercial
product" is. the definition of "pesticide'
product", as proposed, was misleading.
The-Agency is to accord and the defini-
tion teas been rewritten. --
(18) Sectioa 162J(kk) C^162.3(hh)]
Residue. Several commeaters suggested
thst substitution of the phrase "and its
metabolites or degradation products"
for the phrase "dissimilation products".
which appearedin the definition of this
V •
term as proposed,, would be more accu-
rate. The Agency is in accord and has
. substituted the same.
(19) Section 162^imm) [§162.3UJM.
•Teratogenic. Commentess argued that
the-phrase "to produce or incite" which
appeared in the-definition of this term
as proposed is inaccurate and that it
should be deleted. The notion of produc-
ing a functional deviation is important
aaS is retained, but the word '.Induce"
has been substituted for the_ word "in-
cite". Furthermore, comment'ers argued
that use of' the word '"ordinarily" was"
amDiguous. and that the word "heredi-
table" is. improper. "Ordinarily" has been
deleted; Although "hereditable" is an.
acceptable .term,.-"heritable" has been
• inserted in its place. ' '—s^- .-
(20)- Section lB2.3(na), [§ 162.3(kk)3
TosSdty. .(a) Several- commeaters sug-
gested that the definition of toxicity be
clarified by substituting the word "patho-
logical" for. the phrase "adverse, physi-
ologldal", which appeared in the defini-
tion of this term as proposed. The
definition has bsexvrewrittsn to include
both, of these no tions. . -
(b) Several commehters argued that
the "SO days", which was proposed as. an
'indicator to differentiate subacute from
chronic.toxicity, § 102.3(nn).(2) and (3)
was' Inappropriate. The phrase has been
deleted. Instead of 90 days, the Agency
win • distinguish subacute from chronic
toxicity by evaluating results on the
basis of "one-half the life of the orga-,
nism." - - •'.-
(21). Section 162.3(oo)' [§ 162.3(11) 1
Use. (a) Many commenters objected to
the proposed definition of .the -term
"use".-They, argued that .it should be
limited to the intentional application of
a pesticide and that required supervi-
sory, disposal and storage, actions should
not be Included. While the term "use",
is not defined in the Act, it Is repeated
throughout and is- basic. to the Act's
regulatory, scheme. The term's legal
- meaning can be construed from the pro-
visions of the Act and its legislative his- '
- tory. First, the legislative history .clearly .-
establishes that the major thrust of the
1972. FJFRA was to> 'create- a statutory
mechanism to regulate the use of pesti-
cides. The '"misuse" of a pesticide was
made an Illegal act subject to civil and/
or criminal' sanctions, as appropriate.
•Second, the provisions of the statute and
. legislative history ,set foDth a Congres-
sional concern over all dimensions of
pesticide use. Pursuant to section 3(c)
(5) (B) of the Act, a pesticide cannot be
approved for registration unless the Ad-.
ministrator determines that when used,
it will not generally cause unreasonable
adverse effects on the environment.
Sections 19 and 25 (c) (3) explicitly pro-
vide for regulation of pesticide packag-
ing and the storage and disposal of pes-
ticides and pesticide containers. Ac-
cordingly, the packaging of a product
and the directions for and commonly
recognized practices of storage and dis-'
pos&l are evaluated in determining
whether or not & product caa be regis-
4®,
„-.. J
-------
tered. Section 3(d) of the Act provides
• that the use of certain pesticides shall be
restricted to application only by or un-
der the direct supervision of a certified
applicator. Therefore, both the person
applying the pesticide and the supervis-
ing certified applicator are "using" the
. pesticide. Prom the comprehensive regu-
latory scheme of the Act, it is clear that
the term "use" was not intended by Con-
gress Co be synonymous with application,
but rather was intended to-have a more
• expansive meaning which would include
the direction and supervision of an ac-
tual pesticide application, the storage
and disposal of pesticides, and any other
actions required by the.Act and these
regulations.
Some questions have arisen concerning
the implications of the definition of "use"
In these regulations with respect to the
requirement for certification of applica- -
tors. It has been suggested that the def-
inition of use in these^ regulations would
require that persons who manufacture, -
transport, store or distribute restricted
use pesticides will have to be certified,
because such persons are' "using" the
pesticides In question. This view reflects
a- misunderstanding of the structure of
the amended FIFRA,. and the scope of
the certification requirement: Section 12
(a) (2) (F> of the Act provides in per-
tinent part, that it is unlawful- to use a
restricted use pesticide "other than in
accordance with section 3(d)-. . . ." Sec-
tion 3(d) requires the administrator to
classify uses of pesticides for genera] or
restricted use, and provides that in cer-
tain circumstances he must restrict the
application of such pesticides only- to .
certified applicators (or competent in-
dividuals under their direct supervision).
Thus, the requirement for certification
is only imposed with respect to applica-
tion of restricted use pesticides. However,
the Agency observes that in order to be-;
come certified, an applicator must be de-
termined to be competent "with respect •
to the use and handling" of pesticides. A
short explanation has been included im-
mediately after the definition of "use"
In these regulations to eliminate any pos-
sible ambiguity concerning this matter.
(b) Several commen ters were confused
by the definition of the term "use" as
proposed. It has been rewritten for
greater clarity.
(22) Section 162.3(pp) [§ 162.3(mm> ]
Use Dilution. Several commenters argued
that the proposed definition of "use dilu-
tion", was misleading. The Agency rec-
ognizes that a pesticide may be applied
in different concentrations depending
upon the mode of application. The def-
inition has been rewritten accordingly.
(23) Section 162.3(qq) Use Pattern.
A new definition of "use pattern" has
been Included to clarify, in accordance
with the term "changed use pattern",
§ 162.3(k), the indices the Agency will
evaluate in determining whether a new
use is a changed use pattern.
Section 162.4 Status of Products as
Pesticides. This section sets forth the
criteria which will be evaluated to de-
termine if & product is a pesticide prod-
123
. RULES AND REGULATIONS
uct,-and therefore, within the scope of
FIFRA, as amended, and the regulations
promulgated thereunder.
(1) Section 162.4(a) Determination of
Intent of Use. Whether a substance or
.mixture of substances is a pesticide pur-
sua"t to the Act depends upon the use
for which it is reasonably Intended. A
commtnter objected to the statement "in
the regulations, as proposed, that the
intent may be either express or implied.
There is a long standing principle at law
that intent may be either express or Im-
plied. The Agency ha^ always evaluated
the express and implied intentions of the
user of &. product and will continue to
operate on the basis of this standard.
(2) Section 162.4(b) Products Con-
sidered to be Pesticides, (a) A comment-
er objected to g 162.4(b) (3), [§ 162.4(b>
(4)], arguing that a product intended
for use as a pesticide after reformulation
she—, not » -rnsidered a pesticide
product. Technical compounds ar»> cur-
rently register•-•' by the Agency. Amend-
ed FIFRA makes no distiBCtion between
products intended for use as formulated
or after reformulation, and requires
that both be registered. The comment-
er argued that reformulation may ef-
fect .significant changes in the efficacy
and hazard of the pesticide product. For
this-very reason, f 162.6(b)(l) provides
that a product registration may pertain
to only one formulation and that varia-
tions in the formulation of the pesticide
product require separate registrations,
except as-specifically provided in § 162.-
21 (a) of these regulations.
(b) Many commenters argued that
§ 162.4(b) (4) [§ 162.4(b) (5) ] as proposed
is without statutory authority. The Sec-
tion declared a product to be a pesticide
if it is intended for use both as a pesti-
cide and for other purposes and stated
that, such a product is subject to the
misbranding provisions of section 2(q)
(1) (A) of amended FIFRA, both, as to-
its pesticidal and non-pesticidal claims.
Section 2Cq) (1) (A) of the Act provides
that a pesticide is misbranded if "its
labeling bears any statement,- design or
graphic representation thereto or to its
ingredients which 'is false or mislead-
ing in any particular". (Emphasis add-
ed). The statute, therefore, clearly re-
quires that false or misleading state-
ments, concerning both the pesticidal
and non-pesticidal properties of a pesti-
cide product, constitute misbranding.
This is the longstanding interpretation
of the Agency. [See, extant 40 CFR
162.10Kb) (3) (ii)h In these final regu-
lations, for purposes of organization, the
reference to the misbranding provision
of section 2(q) (1) (A) has been deleted
from § 162.4(b) (4) and is now set forth
at § 162.10(a)(5).
(3) [Section 162.4(c)] Products Con-
sidered to be Pesticides and Drugs. Sec-
tion 162.4 (c) as proposed provided that
registration of a product considered to
be a drug as well as a'pesticide, would be
dependent on approval of the substance
by the Food and Drug Administration.
For purposes of organization, this Sec-
tion has been deleted from § 162.4 and
incorporated into 5 162.7(d) (1), Criteria
for Approval of Registration, as a new
paragraph 8 162.7(d) (1) (vi). A complete
discussion of the comments received per-
taining to this Section is found below at
the explanation of § 162.7 cixrvl).
<4> Section 162.4(icJ [i!l62.4fd>]
Products not Considered Pesticides. <•&>
Many commenters objected to the in-
terpretation of the term pesticide in
§ 162.4, as proposed. It had pro-
vided that paints and other formulated
coatings which are treated with a fun-
gicide to protect the coating itself and
which are not intended for preventing .
or destroying fungi after application to
any surface are within the meaning of
the term pesticide. Under this Inter-
pretation, only a paint treated with a
pesticide intended to protect the paint
itself while in the canister would not be-
considered a "pesticide". The comment-
ers have contended that the "Agency's
interpretation, as regards paints and
other formulated coatings, is inconsist-
ent with its. handling of other building
materials. Section 162.4(c) (3) provides
that building- materials which are treat-
"ed-with a pesticide to protect the mate-
rial itself, and for which no pesticidal
claims are.jnade as-protection of oth-
er surfaces or objects in the manufac-
ture, sale; or distribution of the product
are not considered pesticides, and there-
fore, are not subject to the registration
. requirements of amended FIFRA. After
reconsideration, EPA has interpreted the
" definition of "pesticide" as applied to
- paints and other. formulated coatings
which are treated with fungicides, in a
similar manner as all other building ma-
terials. Paints and other formulated
coatings which are treated with fungi-
cides to protect the dried coating itself
and which are not intended for protec-
tion of other surfaces are not considered
pesticides. However, paint products, in-
tended to be applied to a surface to kill
mildew organisms and paint products
formulated to kill or prevent the growth
of mold in food processing plants, dairies
and breweries are considered to be pesti-
cides and will require registration in ac-
cordance with FIFRA, as amended.
Promulgation of the regulations in this
form, represents a continuation of the
current policy.
The fungicide added to the paint.or
other formulated coating to protect the
coating itself is a pesticide and is cur-
rently registered by the EPA. These
products will continue to be so regis-
tered. Before the registration of any
pesticide is approved by EPA the appli-
cant must establish that his product un-
der use conditions^ satisfies all the re-
quirements of the Act. The Agency ac-
cordingly, before registering such a fun-
gicide for use as an additive in paints or
other formulated coatings, must make
the determination that the pesticide's
composition is such as to warrant the
claims made, it will be used without
causing unreasonable adverse effects on
man or the environment, and it other-
wise complies with the requirements
of the Act. The EPA is satisfied that a
thorough review of the fungicide, with
FEDERAL REGISTER, VOL. 40, NO. 129—THURSDAY, JULY 3, 1975
-------
124
••a view towarfi ite cs&dl vss, wffl
tag those- stafesmeats ©2 mildew resist-*
ence whish wffl nofc subject a painfe prod-
uct-to-registemfciei as a
foMotTiag tebal claims, are"
provided BO addifeisasl claims
profesefctaa of esofches surface are
etaewaere'to the Istesliag or In
. Beateteafe—treated with fungicide
to pretest the paint itself from growth.
of Eaildevj""; "Milder Resistant—This
paint conts£ns agents which inhibit the
growth of mildew on file- surf aee of this
paiafe aim"; "Dry coating-of this.paint
mildew resistant";. "Dried, paint "film •
resists mold fungcs"; "Dry enamel
coating reaiste. discoloration from mil-
dew"; "Dried film resists st&ias by
mold":* "A fungicide (or mold' control
Jagredienfe. or saildew resisting eompo- '
nsst), has been incorporated in this.'
product t© mete ite dry Sim milder *•
resistant"; "Treated with fungicide (or
specially formulated) to.resist mildew.
growth oa the paint film"; "Gives mil?
" dew-resistant coattag"; "The mfldew re-
sistance of this outside hoijao.painfe film
Tasds.es It especially- ussful for use in
high humidity areas"; -"Contains °.-° °
to protect the contents from spoilage";
"With, fungicide—Resists film, attack by.
mildesz." - ' ~ ^ '.''
(b) A commenter suggested" that s
/subsss&on ba added to explicitly state
that the term pesticide product does not
encompass a substance or mixture of
substances intended only fo£_2§peri- .
meafe&TusQ to determine its value for
pss&ddal 'purposes or its . toxietty;or
other properties, where the user expects'
ne- benefit in pest control. Such en ex-
plicit stefessjeafc is unnecessary:" The
concept is implicit''in the definition of
the term "pesticide'0" and the discussion
of Determination of Intent of Use -at
Section 182.<1(B). The concept is also in
accord withXl), tg'l62.5(a>]."
Pesticides Exempt from Registration;
Pesticides 'Transferred between Estab-
llsh-ments. (a) In accordance with see-
tion 3(b) (I) of FEFRA, as amended, this
section sets, forth the statutory esemp-
tion from the registration requirements
for a. pesticide transferred from on®
registered establishment to another
registered establishment, operated by
the same producer* solely for packag-
ing at the second establishment or for
use as a constituent part of saother-
peaticide produced at the second estab-
lishment Many commeaters asked that'
the phrase "by the same producer" be
. o? irnder contract"
fes- aMsal Bath. o£ these suggestions con-
Sicfe with the explicit- language of- the
Acfe. Sectiom l®2.5(b)(l) is B.verbatim
rendition o2 the exemption creatsd by
section3(b) (i) of the'Acfe.
The Agency believes that much of the
'comment to this Section wss genera'ted
bs^ coafiasioa es to .the- meaaiag of the
term, "operated by the same, produces."
Accordingly, the/term has been- denned
at. § 132.3 (dd). Aa .establishment pper-
&Sed by tQ© SSSJG producer. Includes one
burned, by the registrant of the pesticide
product and one. operated under coa°
tract with ths registrant of the pesticide
'product-either te package, the 'pesticide
product or USQ the pesticide as a eoa=
stituent part, of another pesticide prod-
uct,'provided thafe the flasl pastieide
product is registered' by • the transferor
establishment. The proviso clause of this
term is very important. Ife Is not enough
' thafe & coafcracfe relationship' exist be-
tween the parties. The tmasferor: estab='
iishmgnfc muafe be the oae that holds the
registration of .the final pesticide prod-
uct. Ths- Agency believes that Congress
in its use ot the term, "operated by the
same producer," has-recognised the com-
mon business practice among registrants
of contracting for the packaging or
formulation of .a, pesticide product.
(b) M»jny Questions have arisen con-
cerning the scope of section 3(b) (1) of
•the Act and § 132.5 (b) (1) of these regu-
lations. A pesticide product, when trans-
ferred from one registered establishment
to another registered •• establishment,
operated by-the same producer for the
- proposes indicated above, is exempt from
the registration requirements of the Act.
It must, however, be labeled so as to meet
the other, requirements, of the Act. A
' sentence has been added to § 133.5 (b) (1)
listing the applicable Sections of the Act.
Agency interpretation of- the similar pro-
vision in the 'Act prior to Emeadmeafe>.
(secttoa4(e) 19OT S2K&A) ...
-(2) Section 132.5(b) (3) 18 162.5(0)1
Pesticides Esemirt- from Reeistratton;*
Pesticides -Transferred, for Purposes of
Disposal. Festicides shipped solely, for
purposes of disposal pursuant to Section
IS of the Act, Part 165 of the regulations,
or an.'applicable Adsaiaistrative order
are exempt from the registration require-
ments of the Act. This provision, like the
- provision -for pesticides teaasferred be-
"t ween /establishments operated by the
•same producer, only relieves the pesti-
cide product of the registration require-
ments o£ the Act. It must still be labeled
so as.to satisfy other requirements of the
Act. A sentence h&s been added to
8 162.5 (b) (S) listing the applicable Sec-
tions ot the Act. • - ' .
(3). Section 182.5(bX(6) Pesticides Ss--
.empt from Registration; Other Bxemp~
tions. A new subsection (8) has been
included to set forth ,the regulatory as-
thority of section 25(b) .of the. Act, Ex-
emption, of Pesticides.
' Section 162.8 Registration Procedures:
All applications for new .registration,
amended ' registration, .-supplemental
registration, and ^registration must
comply with the requirements outlined
atj 162.8.
. (1> faction 162.6(a) Applicant Re-
quirements. The applicant Is responsible
for the accuracy and completeness of all
information submitted in connection
with the application. If the Agency deter-
mines that an application is not suffi-
ciently complete or that modification is
aecessary before a Saal decision on ap-
proval or denial of the application .for
registration, the applicant is notified and
allowed.a- reasonable time within which>
to resubmife the application with defi-
ciencies corrected. A comments?, in reli-
ance , on section 3(c) (6) of the Act,
argued that an applicant should be
granted only 30 days to resubmit his ap-
plication if a notice of on incomplete
application, pursuant to § 162.6(a) (5) is
issued. Section 3(c) (6) of the'Act grants
an applicant only 30 days to correct de-
ficiencies in his application if the Ad-
ministrator informs hi"i of his,int£n€~to
deny the application for registration. A
notice of an incomplete application, pur-
suant to § 162.8(a)(5), however, is not
to- be considered a denial'of registration
pursuant to section 3(c) (8) of the Act.
Therefore, the Agency may granfe the
applicant who has received notice of an
incomplete application a "reasonable
time" within which to complete his ap-
plication. In the event the applicant de-
sires to have his application treated as
having been denied, he may petition the
Administrator for issuance of a notice of •
denial pursuant to section 3(c) (6) of the
Act and § 162.7 (e)U) of-these regula-
tioasr --. . •- > ;
,(2) Section 162.6(b)(3) t§ 162,6(b>l,
Application for New.Registration, (a) At
the present time, before an application
fog registration will bs approved, the
Agency must accept- the final printed
labeling. Several commenters objected to
this policy in general. The Agency's re-
sponse to these comments is found below
at the "explanation of § 162.10(aX6>. A
new § 162.6(b) (2) (i) (A) has been added
to clarify that this policy will continue in
.effect as regards- applications for new
(b) Section 162.6(b) (2X1) (C) (2)
which indicates the factors the Agency
considers in determining whether an in-
gredient is active or iner6, appeared in
the. proposed regulations at § 162.3(c)
(2). It has been transferred to this Sec-
tion for purposes of organization.
(c) Section 162.«(b) (2) (1) (C) (3) pro-
vides that If the functional purpose of
an ingredient is not reasonably apparent
to the Agency, the Agency may request
the applicant to state the purpose of
the Ingredient In the formulation. If any .
ingredient has no functional purpose, the
'Agency may determine that either the in-
gredient must bs deleted from the for-
mulation or that the application will be
denied. Several commenters argued that
this provision Is without statutory au-
thority.- The. mandate of the Environ-
mental Protection Agency is to regulate
the introduction of pesticides' into the
environment and prevent any unreason-
able adverse effect on man or the envi-
ronment. The intentional introduction of
8,
-------
: ;' 125 _;
ROLES-AND
REGULATIONS
a, contaminant Into the environment, for
which no functional benefit can be estab-
lished, may be unreasonable and. unless
the Ingredient Is deleted from the formu-
lation, may bs grounds for denial of the
application for registration.
(d) Section 162.8(b)(2)(v), as pro-
posed, has" been deleted from these regu-
lations because its substance is. inT
corporaled within § 162.8(b) (2) (i) .
•There were many comments concerning
the data requirements of § 162.6(b)(2)
Xv>, as proposed. These are discussed in .
"ihe explanation of § 162.8(b) (3) (1).
below.
-(3) Section 162.6(b> (3) [5162.6(6)].-
Application jar Amended, Registration.
(a) Section 162-6(b) (3) CD (c) provides
for marketing .of a single registered
product under multiple brand names. It
had appeared in the proposed regula-
tions at § 162.6(c) (5) but has been in-
cluded here for purposes of organization.
A commenter asked that allowance be
made for the deletion of specific claims
fjnm a product label If by so doing no
other changes are made necessary. Such
a provision exists for the supplemental
registration, for distributor products,
g I62.6(b) (4). -An. applicant for -an -
amended registration can apply for a,
supplemental, registration of distributor-
products at the same time as he applies
for amended registration. ~
fb) Several commenters objected to
the provision at § 162.6(b) (3) (11) that
•R-naii printed labeling must be accepted
by the Agency before the, application
for amended registration will be ap-
proved. The Agency's response to this •
comment is found below at the explana-
tion of § 162.iO(a) (6).-.
(4) Section 162.6<4> [§ 182.8(d)],
Application for Supplemental Registra-
tion, of Distributor 'Products. Several
commenters argued that the regulations
. concerning supplemental registration are
too stringent.-They misunderstand, the
purpose of supplemental registration.
The Agency merely Intends to allow the
marketing of a pesticide product under
a distributor brand name. The distribu-
tor Is not empowered to formulate, pack-
age or otherwise manufacture the pesti-
cide product The requirements for sup-
plemental registration- are designed to
Insure that the pesticide product is not
(5) Section 182.6(b> (5) [§ 182.6(e) I,
Application for Reregistration. (a) Sev-
eral commenters argued that it is impos-
sible to complete by October .21. 1978
some of the long term testing required
by these regulations for the reregistra-
tion of certain pesticide products. The
Agency has always Intended.- in accord-
ance with section 3(c) (2) of the Act, to
permit sufficient time for applicants to
obtain the additional Information re-
Five Year Cancel-
lation. A new section has been added to
the regulations to include procedures for
the five year cancellation of pesticide
products as required by section S(a) (1)
of the Act. Registration of & product for
which notice c£ 5 year cancellation has
Issued will be continued In effect only
upon the determinatidn of the Adminis-
trator that the registration complies with
all the requirements of the Act and the
regulations which are promulgated there-
under and which are current at the time
of renewal..
Sactlon 1B2.1 Disposition of Applica-
g&Jrss. All applications for ne-s? reglstra-
Qoa, amended registration, supplemental
registration, and reregistration will be
processed as outlined at § 162.7.
(1) Section 162.7(b) Notice of Receipt
of Application for Registration. A uew
§ 162.7(b) has been Included to clarify
that the Agency will acknowledge receipt
of all applications and return to the ap-
plicant s notification of the date of re-
ceipt of the application by the Agency.
Section 162.6(b) (3), as proposed, had in-
dicated that such procedures would ~be
followed In the case of receipt of an ap-
plication for new registration.
(2) Section 162.7(c) [§162.7(b)],
Time for Acting with Respect to Appli-
cation. A commenter asked that the
phrase, "as expeditiously-as possible." be
deleted from this section.and that an-
other phrase be added to indicate that
the applicant will ba notified if review
will take longer than 90'days. "As expedi-
tiously as possible" Is the language of-the
statute, section- 3(c) (3). The Agency, in
fact, intends to notify the applicant of
the expected length of time .necessary to
' process the application. '
(3) Section- 162.7(d)Cl) [| 162.7.
'.(c)(l)J, AprprovaK.of Registration: Cri-
teria tor Approval. . (a) Section 162.7
.'(d) (1) (v) has- beeaV rewritten to more
closely track- the Food," Drug; and Cos-"
'metic Act requirement, for a tolerance •
or an exemption from; a tolerance.
(b) For purposes of better organiza-
tion, a new § 162.7(d) (1) (vi) has been
added to incorporate the requirement of
§ 162.4(c) as proposed-, -which made
registration of a product intended for use
as a drug as well as a pesticide dependent
on approval of the substance by the Food
and Drug Administration. Several com-
menters argued that § 162.4(c). as pro-
posed, should be deleted: and, because
the Food and Drug Administration ade-
quately regulates these products, pursu-
ant to section 25(b)(l) of the-Act, they
should be- exempt from' the provisions
of FIFRA, as amended. These comraent-
ers have failed to recognize the Congres-
sional mandate, to each Agency and the
working relationship established between
them. The language of § 162.7(d) (1) (vi)
and I 162.4CC), as proposed, reflects the
current Interagency Agreement between
..the Environmental Protection Agency
and the Food and Drug Administration,
36 PR 24235 (December 22, 1971).
-(4) Section 162.7(e) [§ 162.7(d) I, De-
nial of Registration'. This section, as pro- '
posed, granted an. applicant the oppor-
tunity to petition the Administrator to
withdraw his application. Implicit in the
concept of a petition is the discretion
of the Administrator to deny such a peti-
tion, language has been added to § 162.7
(e)(2)(ii) to explicitly state that the
Administrator may in his'discretion deny
any petition for withdrawal and proceed
to issue a notice of denial.
" Section 162.8 Data in Support of Reg-
istration
-------
126
a
2T, 19Tr the most
part-cstalogue the specific requirements
which, have been in. effect for the pasfc'
several years- The 'regulations reduce-.
uncertainty by fully Informing the ap=
plicant of' the date necessary to support
'an application for registration. EPA. be-
lieves this will increase, the efficiency of
pesticide research and, development and
result in a, shorter average duration of.
time between submittel of an application
for registration-, and a decision, regard-
ins, the application by the Agency.
The date requirements for recegistra-
Han win not pose a significant economic-
burden on many pesticide registrants..
The data requirements have been tat-"
lored to address the particular concerns
regarding pesticides' already' registered
by the Agency in light of date previously
•_ submitted to, the Agency In support of
"the initial.registration und the pesti-
cide's use history. The date .require-
ments.-for reregisteation 'can generally
-be satisfied with tests on the active in~
gradient. This fact greatly reduces the
burden on many pesticide registrants be-
cause an evaluation of one active ingre-
dient will satisfy the requirements or
many formulated pesticide products. In-,
addition, if the date have" previously
; been submitted to the Agency, as for ex-
ample in support of a tolerance, and they
me.et the intent and reliability standards
of the Registration Guidelines, no new
submission will be reared. Moreover,
9 162.8(b)<5) (11) provides that Jf'data
are required which ctnnot reasonably
be-anticipated to be compiled within tha
parted for reregistration, the Adminis-
trator may, in his discretion, classify
and reregister the pesticide product for^
s> reasonable_j>erio General, (a) Sev-
eral 'eommentsss suggested that % 162.8
b® deleted, from, the regulations and
placed in the'.Registration Guidelines.
.The purpose of the Registration Guide-
lines is to specify the'kinds of informa-
tion which wilL be required to support
the registration of a pesticide. 'Section
162.8 of these regulations does-not pre-
empt', til© Guidelines. It is Included in
these regulations to delineate the-majer
date requirements of the Registration
Guidelines and direct the- potential ap-
plicant or other interested party to the
Guidelines. Many of the date require-
'ments se£ forth in Section 162.8 &re-con-
ditional and will only be required f or
"those products which meet the indicated
conditions. .The applicant Is referred to
the Rsgiste-atiqn Guidelines to determine
the-detailed date, which are required" to
support e, specific application for regis-
tration:. The Guidelines also specify ac-
ceptable test methods and protocols to be
followed in accumulating the date.
.•••' (b). Several commenters argued tha£
the date requirements of'these regula-
tions and the Registration Guidelines,
even taking into account the conditional
nature of many of the date requirements,
are' inapplicable to certain pesticides or
pesticide products and. are not necessary
'•loss e, determination of whether .such
pesticide product.will generally cause un-
reasonable adverse effects on manor the
environment. The- Agency has attempted
to consider all pesticides in developing
the date requirements. The Agency rec-
ognizes, however, that these regulations
and the Registration Guidelines may not
have taken into account all relevant fac-
tors for. an pesticides. Accordingly, the~
proposed regulations at i 162.8(b) (2) (i>
hsd 'provided, for a waiver of date re-
.quirements upon petition of tioe appli-
cant. That precision has been modified
end a new- § I62.8(a) (3) has bsen in-
cluded to specify the detailed procedures -
and basic standard to be applied by EPA
for' waiver, of a .date requirement
' specified in.these regulations oe Che Reg-
istration-Guidelines; Waiver o2 a date re-
quirement is permissible only if the Ad-.
ministrator determines (1> that' the-
compdaition, degradability, proposed pat-
terns of use or other chemical or physical.
properties of the pesticide, relating to an
eyil&ation of the effects on m™* or the
environment, are fundamentally different
from the properties considered! by the,
Agency In establishing" the date require-
ments of these regulations or the Regis-
tration Guidelines, and therefore (2)
that the date are not necessary in order
for him to determine whether suchr spe-
cific pesticide or product will generally
cause unreasonable adverse effects on
man- or the environment.. Generally, an
applicant must initiate the process
and submit a written statement set-
ting -forth his reasons for requesting.
a waiver, from a date requirement.
In the case of reregistration, however,
the Administrator may initiate the
waiver aS'& date requirement by so
'indicating in hfa - solicitation of ap-
plications for reregistration. The Admin-
istrator, will make a written finding with
" respect to 'waiver of e date requirement. •
In the case of the approval of any ap-
plication for whic& netice of application,
was published in. the FEDERAL REGISTER ~
pursuant to § 162.6(b) (6), if: the Admin-.
istratqr determines to'waive a date re-,
qulrement, the notice of approval issued
pursuant to 8 162.7(d) (2) shall list any
data, requirement which has been'waived
and brefly state the basis for such waiver.
In the case of waiver of a date require-
ment initiated by the Administrator in
the solicitation of applications for rereg-
istration, the notice of 'solicitation shall
list any date that have bsen waived and
briefly state the basis for such .waiver.
Notice to the public of-the waiver., of a -
date requirement satisfies EPA's respon- '
slbility under" the~Act, these regulations, :
and the general principles of Adminis-
trative law to set forth the rationale
for any departure from its regulations! •
_ (c)- A co'mmenter requested that EPA
require ttie applicant for both new reg-
istration and reregistration to submit all
relevant information available from sci-
entific literature and.other sources on the
potential adverse effects of a pesticide.'
In the proposed regulations-at § 162.6(e)
(3) (vlli), ttiis provision'by its terms ap- «
piled only to reregistration, although the
Agency intended that the "requirement •
apply to- all registrations. Moreover, we
believe that this provision more properly
belongs in 1162.8. Accordingly. § 162.6 (e) -
FS9ESA!,- [JSgttTEEWOL'fl&, NO; J 2?—i-THUISBAT, JHIY 3. WS
-------
(3) (viii), as proposed, has been deleted
and a new i 162.8(a) (4) has been in-
" eluded to specifically impose upon the
applicant the responsibility to submit
any factual information which' has been
obtained by him or come to his attenti in
regarding the adverse effects of his pesti-
cide on man or the environment. Such
information- may include, but Is not
limited to, published or unpublished
laboratory studies and accident experi-
ence. . •"•'-,•
• Several commenters objected to the
policy of this section. They argued thai;
the applicant should only be responsible
for submitting his own data and not data
found in the general literature. Section
6(a)(2) of the Act and § 162.8(d) of
these regulations imposes on the regis-
trant the afarmative duty to report any
additional factual information regarding
adverse effects on man or the environ-
- ment of the pesticide. EPA interprets re-
port of scientific finding-; contained in^
the general literature as within that
.duty. This same affirmative duty is Im-
posed upon the applicant for registration
"as. well. The burden for establishing the
safety of a product is on the applicant at
-all times. He must convince the Admia~
'istrator, in part, that the pesticide wiU'
'perform, its intended function and thafe.
: it will be used without unreasonable ad- ,.
verse effects on the environment before
the Initial decision may be made to reg-
ister the product. This duty falls on the
applicant and registrant because they
are in the better pcsition^to monitor the
literature as regards a particular pesti-
cide.
. Many commenters expressed support
' for- the Section as proposed, and asked
that penalties, as for example immediate
. cancellation or seizure, be established for
the withholding of information. The civil
and criminal penalties arising pursuant
to-sections 12(a)(2)(N) and i4 of the
Act are the statutory remedies for
achieving compliance with these- regula-
tions.
(d) Both §162.8(b)(I) (ii) and (ill),
as proposed, have been delated from
these final regulations in order to avoid
redundancy. The substance of i 162.8 (b)
UHii) is repeated at i 162.8(d). The
substance of § 162.8(b) (1) (iii) is re-
peated at §162.8(b) (4).
(3) Section 162.8(b) (2) Data Require-
ments for New Registration. Efficacy, (a)
• A commenter suggested that 8 162.8 (b)
(2) (i) be amended to require only date
necessary to support the label claims for
effective dosage and dosage range. This
suggestion must b® rejected because
without data to support the minimnna
effective dosage and effective dosage
range, the Agency can not be sure that
the correct dosage and dosage range have
been assigned for the pesticide product
use(s).
(b) In response to comment, a new
9 162.8(b) (2) Uv) has been included to
delineate the Registration Guidelines re-
quirement for date,, when appropriate, to
support the measurement of toxic effects
. &> plants or animals that are host to the
" pasts. Tais iafonnatica, when relevant,
has customarily, been required of appli-
cants for registration.
•'. 127 ' V
RULES'AND REGULATIONS
- (c) Section. 162.8(b) (2) (3>(i) would not be
available to formulators of a pesticide
product. A formulator may rely on the
data submitted by the basic manufac-
turer of the pesticide provided he com-
plies with the procedures - established
pursuant to section 3(c)U)(D> of the
.nx; i>.
(b) Sections 162.8(b) <3Mi) and
162.8(b><3. "MBXD require tLe appli-
cant to subiait data relative to .the com-
plete general chemistry of the pesticide
and the pesticide formulation, including
the complete composition-of the tech-
nical chemical, and the chemical names
and percentages of all impurities. A corn-
men ter'argued that these' Sections are
tea stringent and that the applicant
should, only b® required to submit infor-
mation relative to the composition of the
technical chemical, including the per-
centages of all impurities and the chem-
ical name of known Impurities. The
Agency recognizes that the best scien-
tific methodology may leave a percent-
age of impurity 'unidentified. As deter-
mined by the Administrator, on a case
by case basis, an application for regis-
tration may be approved where a very
small percentage of impurity, is uniden-
tified. i£ the Administrator determines
that the best available methodology has
been utilized to evaluate the pesticide
and the- pesticide formulation, and thafe
use of the pesticide will not generally
cause unreasonable adverse effects on
man or the environment.
.(c) Several commenters argued that
EPA has no authority"to require data rel-
ative to the basic manufacturing process
of the-technical chemical, % 162.8(b) (3)
UMAH2), or of the pesticide formula-
tion.' 1162.8(b) (3) (i) UKA)t2) and § 162.3(b) (3) (i)
(2) have been required by EPA prior-to
the promulgation of these regulations,
.pursuant to the authority of the 1947
PIFRA. Nothing in the legislative history -
or language of the- amended Act indi-
cates a modification of that regulatory
authority. Such data, moreover, are re-
quired before issuance of an experiment •'
tal use permit, pursuant to section" 5 of •
the Act, for use of an unregistered pes-
ticide product. 40 CFR 172.4(b) (3>,
40 PR 18780, 18784 (April 30,1975). -___
(d> Section 162.8(b) (3) U) (A) C3>_ re-
quires data on the purity of starting and
intermediate materials used in the man-
ufacturing process. Several commenters
suggested test methodology for securing
these data. These comments have been
considered in developing the Registration
Guidelines. ." - • ' _ .-
(5) Section I62.8(b) (3>(ii) Data Re-
quirements for New ^Registration. En-
vironmental Chemistry. In response- to
comment, this Section has been subs tan- •
tially rewritten, to clarify the conditions.
under which specific data relative to the
environmental chemistry of the pesticide
will-be required. Data on field stability,
' persistence,."degradation, accumulation.,- -
and mobility'are generally required only
if the pesticide is intended for outdoor
application. Information to support the
"safe disposal" of the pesticide formula -
tlon and pesticide container, as defined at
40 CFR 165.1(s), is generally required of
all pesticide products.- The applicant is
referred to the Registration Guidelines
for Uie- detailed conditions for the data
requirements and for acceptable test
methodology and protocols.
(6)' Section 162.8(b) (4) Data Require-
ments for New Registration. Product
Hazard, (a) In response to comment,
§ 162.8(b)<4> has been substantially re-
written to clarify the conditions under
which specific data relative to product
hazard will be required and to refer the
applicant to the-Registration Guidelines
for the detailed conditions for such test- •
ing. The Guidelines specify, in addition,
whether the data are to be derived from.
tests on. the active ingredient (s), the pes-
ticide formulation, or the major metab-
olite(s) degradation and/or reaction
product(s). - • • ".
As is discussed • below, no mutagenic
requirement normally exists for reregis-
tration. For purposes of new registration,
the applicant is referred to the Guide-
lines and Appendices thereto for the con-
ditions under which such testing will
ba required and for the protocols to be
followed. The Guidelines have just been
published as proposed and the Agency
especially welcomes comment concerning
this data requirement
(b) In response to comment, § 162.8
(b) (4) (i) (C) has been amended to re-
quire, instead of merely diagnostic and
antidotal information, diagnostic, first
aid. palliative, and/or antidotal informa-
tion. Commenters correctly pointed out
that the language of the proposed regula-
tions was too restrictive since tbare is no
known effective antidote for the majority
of pesticide products, following sufficient
exposure.
FEDEKAl-BEGISTEB, VOl. 40, NO. 129—THURSDAY, JULT 3,. 1975
-------
/c? RwsBtotTKtfyssm,. (a.)- Ssveral
ts asgusfi that ttes date re-
quteemeats for rerecdsfeaSion are too
oua pastiaMa to aofe eo teporteafe sa Qj©
facfe.og esposure. A/eebrdSaglsv, o tsrato= -
to- the data, requirements for- new regis- •
Other commeatsrs argued that
date, reguiremeats for reregistration
too burdensome. The date require-
ta a
'as> a. eoadfflca
(c)'S®saoas
ixuaaaas," ^T-
, UD, (iii) aad (iv)
ditional mutageaie testing wiS apt be'
re^uirefl for pHrsJcsss a£ reregistratiea,,
except where tae Agency determines
thai, for £3 individual pesticide or pesti-
cid©' ppseuefe, mutegeaie evaluation.
should ba completed, ea^parfc of tae re-
registration determination pursuant to
concerns-
We bavs indicated these usa patterns,-
chemical structures end exposure levels
for w&Ica a determination on. any 50°
tential risks to Qie aesia asad'safety
"of man or the environment Is required.
prior to registe-aaoa. Sn light o£"3i® use
history and prior registration of. these
pesticides, we have determined that eval-
uation of the.data Indicated at H
is necessary aad'suSsrienfeior fee deter-
miaation of. whether. OE not reregistrs-
tioa of the pesticide product will eaus®
chronic f&ediag_and EeprnducMve stodtss-
of t&e- ectivs' ingr'edien£(s> will bs re=
quired for pssticides wbiela need a toler-
ance : or am esEmpttoa from. too. require-
(8> Section i62.8(d) Additional Date.
Sate secttes. has beea rewritten, to em-
phastes aad clarify for. the registrant
fas submit any additional data
by the Administrator. In addi--
ttiis • regiatee=
.meafe represents s change from Sis .ep-
isting policy of requiring oaly sube-eute
th& eaviroiasasnfe, EPA realizes thafe -fall
compliance 'with the date requirements
imposed os new registrstions would ba
desirable for reresisfcsratiom -as well. By
October, 1976, however, EPA must rereg°
Ister.ia excess of 30,000^pssticide prod=
ucts. Xfe would be admialstratively lmpds=
sible to require all of these products to
satisfy the data requirements forjaew
registraaon. Five year renewals off reg-
istra&om, however, will bs- processed oa-
K staggered basis; "it Is afe this junction
thafe Sis "then current data requirements
for new regisbra&on will 'apply to all
products previously registered.,, by. the
X8ffl.ia) defines.t&® term
residua"1' to mesi
amount of a pestieide chemical
tag to or oa a raw agxlcultoaraB. co"m=
modify. or group of raw asricultaral
Js ttoat would result la. a daily
; to section ffCa) (2) of tSie
Act, to immediately submit to the Agency.
any factual information regarding ad-.
verse effects on man or the environment
'ctf-th® pesticide. Suca information in-
cludes published or unpublished.- lab-
stsdfes. (Whether as sot con-
Kegistrants of pesticide products, thafc
come within the criteria specified afi^
9132.S(e), will be required to submit such-
addiMonal data prior to reregistration
unless (1) such data have previously been-
submitted to the Agency and the data
meet the inteafe and reliability standards
specified in these regulations and the
BegJstration Guidelines, or (2).the Ad=
ministeator determines, pursuant to sec-
tion S(e) (2) of the Act and g 162.8(b)
(5) (ii> of these regulations, that the data
cannot; reasonably be -compiled within
the time for reregistration, that the pes-
ticide .otherwise satisfies the ^require-
meats of the Act and these regulations,"
and feat the pesSeide doss 'not meet or
esceed- tHE-csiteria for risk safe forth in.
8 182.H(a)(3). Sa this, latter case, the
Admiaistrator -may classify end rereg-
ister iEhe psstidde for a reasonable period
of time psading completion of the re-
quired testing. The reader is referred to
, the discussion of 8 i82.6(b> <5) (ii), &^o^e.-
(b).Section iG2.8(c) <3H1> has bees
modiflsd in response to comment to alter
the conditions under which a teratogeaie
• evalustioa of s pesticide will be required
for reregistration. The proposed regula-
tion has required the testing "if the pes-
ticide use results in significant exposure
to Women in residences enclosed working
• spaces or their immediate vicinity." The
Agency has determined that this. data
requiresienfe wss too restrictive;
~niflcant ;pn, the baste off scientific juds-
menfe of adequate safefej' data." (Ordinarily
this will add to the diet.aa amount, whicfe
will be less thaa l/2000th of the amouafe
that has besn-demoastratejd feo have- no
effect from feeding studies oa the most
sensitive '-.animal species tasted. Sues.
~tozicity studies shall usually include
at least 90-day feeding studies ia two
specie^ oS mammals." XBmphasis added-)
In the past, the Agency has frequently
considered 90-day feeding studies to be
sufficient to support the pstitioa for the
establishment of &: toleraace for negli-
gible residues. However, the Agency has
• determined that the resul&rof such. .SO-
day studies cannot always establish that
•-a residue- is tosicoiogically
accide&& experience-. F£hes& requirements
recosa&s that the registrant is in the
best position to monitor sash sources.
^ith respect to a particular pesticide;
and that additional data may ba required
where it Is appropriate in order to eval- •
uats efficacy or hazard. Moreover, file'
Agency will also take Into account evi-~
dence- submitted by other parties.
Section 162.26) Labeling Regtiifements.
.Section 162.10 implements the new label-
ing requirements of JOTKA, as amended*
A 90-day time, period, will generally ba
inadequate to confidently predict the
effects from life time exposure. Human
exposure to some chemicals such as
carcinogens- can have significant chroaic
effects evea-at very low- levels. Moreover,
as explained in the recent decision of
the Administrator suspending .the regis-
trations of pesticides coatalaiag Aldria.
and Dieldrin and in the-United Statss
Courfe of Appeals for the District of
Columbia ~ Circuit' opiaioB aSlnnins -that
decision, although no efiesfc may theo»
retically eidst, in cancer testing it Is
of tea impossible to determiae sQcfe- o
safe -level. Furthermore, the Agency is
aware of no data ts justify .waiving of
the requirement for chronic feeding and
reproductive studies fo? those pesticides
' which leave residues in food at very low
levels. Aa_ explanation of the- waiver of-
data, iequiremenfc provision appears -at
the Preamble discussion of § 162.8 (a) (3)»
(d) Section 182.8(c)(3)(iii>,.as pro-
posed, has been, deleted from these final
regulations/ The Agency is- currently
re-evaluating existing requirements for
mutagenicity testing and protocols as
part of the development of the Guide-
lines. Until this review Is completed, ad=
tive value of labels and labeling In gen- •.
®ral. Section" I2(a) (2) (G) of the Act
makes it. unlawful for a person to use •
any regisfegred' pesticide in a manner •
^mconsistent with its labeling. Several?
commenters suggested that Sse phrase -
"use inconsistent with the labeling" be
defined in these regulations. Suck, a task
would bs Impraetleerbeeaus© the phrase"
has a- different meaning la, each of sev-
eral regulatory contents. Xn order to re- ,
spond to specific questions as they arise '
and keep the public Informed of Agency •
policy in this regard, KPA,has- instituted .
s series of Pesticide Enforcement Policy.:
Statements to provide public notice of
instances in which., deviations from the
precise language of a product label will •
not subject the user to enforcement
liability. See 40 Fa 19526 (May 5, 1975).
Many changes ia labeling requirements •
were recommended by participants in
the KrsS national Symposium on Pesti-
;cide EaSjelins. June 3-4, 1974. Most of"
these suggestions have been incorporated '.
Sato these regulations, as for example
.the format changes and grouping of use .-
and warning and precautionary state-
ments. Adoption of some of the recom-
mendations, will be deferred until after
completioa. of the reregistratioa effort
because of the complexity of the provi- .
• sions and the far- reaching effects which
are to bs anticipated. Included within
this class are suggestions that nontech-
nical homeowner pesticide labels be ac-
cepted, and thai master labels for use
directions oa an active Ingredient basis
be adopted. Officials of the EPA will bs
conducting Regional Label Symposia to
secure public participattpa to tha.devel- ;
3.
-------
opment of" forthcoming standards for
pesticide labels. .
- (1) SecOeb ifi2.iO(a) (2) Prominence
and Legibility. Section. i62.10(s) (2) (IS)
(A) provides.'that aH required label texts
must be set to 6-point.or larger type.
Several commenters argued that this re-
quirement Is overly burdensome and
that it does no& provide latitude for small
products. The type size requirement is
mandatory because It improves the com-
municative value- of the label text. A
manufacturer of a small pesticide prod-
uct. In accordance with § 162.10(a) (4)
(1), Is encouraged to securely attach
labeling to the immediate container of &
pesticide product. Such labeling must
reasonably be rarpec.tpd <3> Language to
be Used. All label or labeling text must
"appear in the English language. The
proposed regulations had provided. In
addition, that when_text in another lan-
guage Is considered necessary, the com-
plete label text must appear in both''
languages. Several commenters argued
that space limitations do not always
permit complete dual language labeling.
'•'• This requirement has been deleted from
• these final regulations. The Agency may •
determine that for a particular pesticide,
additional text "In another language is"
required to protect the public. In- that
case, depending- on the nature of the
hazard of the pesticide, the complete
label text may be required In both lan-
guages, or the phrase "If you cannot
read English, do. not use' this product
untfl properly Instructed." In Qxe lan-
guage of the anticipated user of the pes-
ticide may be accepted. : .
(3) Section 162.10(a) <4)~ Placement of
•- Label, (s) Several questions arose con-
cerning g 162.10(a><4) (I), ES proposed.
These regulations are Intended to- con-
tinue EPA's present practice of requiring
• a full user-label on the outside wrapper
or container of & retail package, if the '
Immediate container of the pesticide Is
enclosed within a -wrapper or outside
. container through which the label of the •
immediate container cannot be clearly
' read. The language of Oils section has
been rewritten to clarify the Agency's
intended practice. /.'
(b) Several commenters argued thafc
the requirements at g 162.10 (ii)
.: for labeling of tank cars and other bulfe-
containers, as proposed, were inconsist-
ent with the requirements imposed by
the Department of Transportation on
these same containers. The Environmen-
tal Protection Agency is concerned with
securing uniformity of regulation. Acr
• cordlngly, this section has been rewritten
so that the EPA regulations concerning
transportation of pesticides are consist-
ent with the regulations of the Depart-
ment of Transportation concerning
transportation of hazardous materials.
-A separate subsection has been included
to specify the labeling required for pesti-
cides stored In bulk containers.
(•3) Section 162.10(&)(5) Petee of
Misleading . Statements, te) Section
162.10(a) (5) provides that a pesticide
• 129
x RULE'S AND REGULATIONS
Is misbranded if its labeling is false or
misleading In any particular, including
both • pesticidal and non-pesticidal
claims. The specific reference to non-
pesticldal claims had appeared in the
proposed regulations at § 162.4(b) (5).
Coirmenters argued that the Agency
lacks statutory authority over the non-
pesticldal claims of a pesticide product.
Our response to this comment is found
above in the discussion of 1162.4(b>.
- (b> Section 162.10(a> (5) (5) (vi). They
argued that & per se rulem&king a trade-
mark which suggests one or more, but
not all, principal active ingredients in a-
pesticide & false or. migigaxftpg statement
is aofc-in accordance with accepted prin-
ciples of trademark law. In determining
•whether or not to register a. trademark,
the Patent Office makes no determina-
tion of its legality under the FIFRA, as
amended. Therefore, registration, of a
trademark. cannot be accepted as -evi-
dence that a name Is legal under the Act.
If a name is false or misleading, it is &
violation of FEFRA, as amended, whether
or not it-has been registered as a trade-
mark. . - .'•
(d)' Several commenters" were con-
fused by § 182.10(a) (5) (s), as proposed.
It has beea rewritten to give examples of
non-numerical and/or - comparative
statements on the safety- of & pesticide
product which the Agency considers to.
be false and misleading-, within the
meaning of section 2Cq)U)(A) of the
Act.
. (5) Section 162.10(a) (6) Final Printed
Labeling. At the present time, before a
aew registration' will be approved, the
Agency requires acceptance of final
'printed labeling. These regulations con-
tinue this policy with, regard to approval
of applications for new registration,
g 162.6(b) (2), and extend the policy to
cover approval of applications for
amended registration, § 162.6(b) (3). and
approval of applications for registra-
tion, g 162.6(b) (5). Commenters gener-
ally objected to this policy. They argued
that the practice is burdensome and.
laden with delay. Some commenters
made & distinction between applications
for new registration and applications for
amended or reregistratlon, arguing that
though acceptance of final printed label-
ing, is appropriate before approval of an
application for new registration. It Is not
necessary before approval of an applica-
tion fos- amended or reregistratlon. The
Agency can make no such distinction In
-Qie ease of label review since section
3(c>(5)(B> of the Act specifically re-
-quires the Administrator to determine
that labeling is-in compliance with the
Act before registration of a product. Re-
view of the final printed labeling is.
therefore, necessary before any applica-
tion for registration is approved. EPA
will review the tinal printed labeling us
quickly as possible. If tt Is Identical to
the conditionally accepted labeling, no
appreciable delay in approval of the ap-
plication should occur.
(6) Section 162.10tg><3> Narr.es io &<.-
Used in Ingredient Statement. A com-
menter objected to the language of
§ 162.10(g) (3), as proposed, arguing
that common names are assigned. to"
active Ingredients by special natiorjil
and International, organizations such.as
the American Standards Association and
the International Standards Organiza-
' tion, and that the Ageiicy should merely
accept these names. Section 25(c) (6)' of
the Act authorizes the Administrator,
alter notice and opportunity for hear-
ing, to determine and establish suitable
names to be used in the ingredient state.-
. ment. Accordingls. the Agency will com-
pile and promulgate by regulation a. list
of acceptable common T""T"?q, Interested:
-parties will be afforded opportunity--to-
comment before adoption: of these names, .
and consideration will be given: to those
names assigned.by the special national
and international organizations. .-
(7) Section 162.10(g) (4) Statement of
Percentages. A commenter suggested .
that if the use(s) of. the pesticide is ex-
pressed as weight of active ingredient
per unit area. & statement of the weight
of active ingredient per unit volume of
the pesticide formulation should:be re-
quired in the ingredient statement be-
cause unless the precise total weight per
unit of volume is known, It is impos-
sible to determine the amount of prod-
uct to use. The Agency agrees that this
Information is' necessary In such in-
stances, and has included such a provi-
sion in 1162.10(g) (4). -
(8) Section 162.10 (g) (6) Deterioration.
(a) Section 162.10 (g) (6) (1), as proposed.
required the statement "This product is
subject to deterioration. Not for' sale or
use after [date]" on any.pesticide prod-
uct subject to significant deterioration.
Many commenters objected to the re-
quired label statement-^'This product is
subject to deterioration." They argued
that it has unnecessary negative conno-
tations since all products are subject to
some .deterioration, and that such a
statement Is not required of products,
such as film and drugs, which also may
deteriorate over time. They also main-
tained that the phrase "Not for sale or"
use after [date]" will adequately pro-
tect the public. The Agency agrees that
a statement of expiration time will ade- .
"quately protect the public and accord-
ingly these regulations have deleted the
requirement for the label statement
"This product Is subject to deteriora-
tion."
-O>) Section 162.10(g) (6) (11) provides
that the pesticide product must meet an
label claims up to the expiration time In-
PSDE3AI, RE6JSTEB..VOL 40, NO. 129—THUBSDAY, JU8.V 3. 1975
-------
dicafesd oa t&s latesL Sa^eroU commeatsrs
i fe® product from the chcanels
?• teoste offear fea date «? esB>lrsSoa ten
A KgSsfesafe sasy stobSMa: fey
msy Bpjjsaz? elssw&ere. "Hie human
S iS2.10(h) (i), child
& 182.10 (h) (1) (ii). sad
of PFBC-
162.10(h) a) (1M), most
(c) Several corasienfesrs asked that
the provision at § 182.10(h) Cl) (1) (D) .
the hamaa hazard sisnal word
OE &E Toaicity Catsgory IV
pesticides,, ^ba deleted. Tiiey correctly
pointed oafe fesfe § 162.1@Ch) (2) (D (B)
S 1@3.1©<&> (2) (S), e^=
feessM, 0 XS§.JO(ffl) (2) (fi) „
^Ssyaassi 03- cfe:^s2ssl hesagids, S 482.
lOttaXSXJM),!
«3e2>CfflBB
.
AstataSsteaSor has ao stafeatory au= •
to regutea feat the asms c£ to
tagrsjSieat appear, OH labefflsag
fcs- dets?=
jf '&:
eSde ES-S®S for^ to fee tebl® a6 8"
AifisaiaSatemto? determte^i feafr ofeitoffi! provided fesfe
? e.
BE IngredfcsaS may pass
of fee effitfteoament effijJ t&afi fee
should be gives noSee of fee-
SueS a- position contradicte! fee Admin-
teteator's teaic ' oblisBtioa usdes- fee
ameaifiefi'FJFRA of determining fee rislss
whiefe may bs gcssfi b7 a
fee mec^s
to tidessisatzsiy eoatsel ass tm-
rials. Bepsading os fee jlsla
iavolved, fee- Admiaisfemfeog Is authorized
by fee smeaded MFRA to: (D deayreu-
JsteiSoa or ccneel aa existing reglstea,-
tioa, (2) classify the pesticide far re-"
stslcted use, oe ra) require specific label .
eopdlas^, the regralafcions
fee Admlnistratoi? may re-'
fee listSag of iaest lagredleats oa
where the Ingredients msy pose
s hazard; TMs requSsisaent 'doss aofe
affect fee Administrator's authority to
require testing of Saeriis or to take other
regulator? action if the label statement
does aofe protect against fee ha^rd.
; (to) Other commeaters suggested feat
all inert ingredients be listed in fee ia-
gredienfe statemeafe or. Sa fee alternative,
thafe fecsa -Inert ingredients known to be
• hazsrdous be listed in fee ingredient
•statement and an opsn file' of all fee
• inert ingredients of each pesticide prod-
•ucfe be maintained for public -inspection.
FEFKA» as amended, does not require fee
' name of all inert ingredients to be- con-
tained. in fee libs! ingredient statement
and therefore, barring a determination
'Of hazard to man or fee environment,
the name of fee Inert ingredient (s) • of a
pesticide formulation will not be required
in fee label ingredient statement. In the
event of an accident, it often is impera-
tive for fee attending- physician to Iden-
tify fee Ingredients of fee pesticide
formulation so that appropriate medical
treatment can be provided. KEfl. Is con-
sidering Institution .of a toll free tele-
phone service to provide such informa-
tion in the case of a medical emergency.
. (10) Section 162.10(h) Warnings end
Precautionary Statements, (a) The com-
ments indicated much confusion regard^
ing. placement on the label of the warn-
ings and precautionary statements
required by this ssctioa. There are two
general categories of warnings and pre-
cautionary sfeafeamente— those res&uired to
appear oa fee front panel and those
of feg-C^oas
foe dwsfe os". m&6 OF parts per
medium fo? geo os*
argued feat us® og fees© two
of
te?
oao- scsis
ofeer.- To clarify feis Sectioa, fee
of tosicity on the basis-of L
lios: of medium has beea deleted.
(11)'- The- atimerteaJ criteria for assign-
meats are rejjuired fa? Category %V Pes-
tlsifies. There is. ao contsasiictioa be-
fcwees -feesa too sestions.
ary ' stc&esaiaxfe is xsot s huaxas,
fe' Is the «Erres6 Agency
to sen^ase the hmssaa haraiTi,
signal word "Caution" osi effl: Category
W. pesticides. "Khe nature of pesticides,
is general, is sraeh th&fe all ssusS to han-
dled wife eaetion. .
, ' - <^l>- Csj^fflsemtsrs argued tha* fee pre-
cautionary stetemeate oiutliaed - in
§ 163.10OJ) (§) (»i (M>, said (iffl) are
taeoaaplete. Tnss Sec-
ern intended merely to> 62 ffiastra- -
of -precautionary statemeata which
may be accepted. The statements should
be modified to reflect fee specific- haz-
ards oS a particular pesticide product.
Ql> Seetioa 182.10(1) Directions for
Use. Sebtioa. lS2.10(i)-(2)(2) h^! beea-
ssaeaded! to specify with greater' clarity
have bees, relaxed to
fees® Qnal resulatioaa by s factor of tea,
On fee basis of &'review, of fee use his-
tory and available scientific litsj-atee,
EPA has. detertained feat fee proposed
regulations wers "overly stringeafe and
tha'o fee public and fee environment •wBl
ba protected under fee regulations as
now published. SadWduate esposed to
peatteJdes meeting fee proposed criteria
would very. Ifeely have - experienced
dennally tozie 'effects more significant
than fe& inhalation effects. "~-
- (3) Bye effects—Several commeafcars
correcQy 'painted oufe feat pursuaafe to
the . regulatioas . as:, proposed • sui*.
stances which are corrosive to the
eye were not explicitly placed into
Tosdcity Category I. This was an error.
The Agency intended to continue its cur-
rent practices regarding assignment of a
tosieity category on fee basis of eye' ef-
fect. Language to this efiecH has accord-
ingly been included. Other commeaters.
proposed schemes which used coajunc-'
'tivitis and iritis as indicators of tozicity
for. eye efiecta, The Agency interprets
_ these conditions as wifeia fee generic
term "teritatioa,'0 which Is used in fees©
effects—As wife fee toxicity
categories for eye effects,, fee proposed
regulations regarding sldn effects did not
clearly indicate feat substances corrosive
to the skia fall toto Toxicity Category X.
Sjanguage to feat eSecfe b«»^ been in-
cluded ia feeso flnal regulations. In ad-
dition, fee_tosicity category iato which
a pesticide will fan oa fee basis of skin
effects has' besa relaxed because fee
Agency has determined feat fee more
stringent criteria coataiaed to fee pro-
possd regulations are not. necessary to
profeasfc asaSast aaticipated adverse skin
effects from pesticide use. .. -
DJreatioaa for Use of products classified
for restricted use. Section-162.10(1) (2)
-teXCD) .provides that the category or
categories. of a certified applicator to
whom use is restricted must be included
to the Directions for-Use unless the
Agency determines that fee product may
be used by any certified applicator. Sec-
tion 168.100) (2) (x) (E> provides feat a
statement that fee pesticide may be ap-
plied under the direct supervision of a
certified applicator who is noS physicallj
present at the site of application but
nonetheless" available to the person ap-
plying the pesticide, win be required in
•fee Directions for Use, unless fee Agency
(determines .that fee pesticide may only
_ be applied under, fee direct supervision
.of a certified applicator who is physically
present. '
(12) Section 162.10(J) Statement of
Use Classification. Section 162.10(j) re-
quires that by October 22,1976 an pesti-
cide products must bear the appropriate
statements of use-classification- as de-
scribed in paragraphs v(l) and. (2) of
. that section, General Use Classification.
land Bestrioted Use Classification, re-
'spectively. - . " _ • , '. . i
(a) -Section 162.10(J) (2) provides that,
'if us® of a pesticide is restricted to -a
certified applicator, fee following state-
. meat Is reijuired oa fee product label:
"For retail sale to and application only
by Certified Applicators or persons under
their direct supervision." Many com-
menters argued that this provision is
. without statutory attfeority. The legisla-
tive history of amended FTPRA clearly
indicates that Congress contemplated-
feat certain pesticides should be removed
from, the general public domain, for use
only .by certified applicators. In the pres-
entation of the bin 'on fee Senate floor
it was esplaJaed: "In order to provide
for a more finely tuaed control of.pssti-
-.cide uss, the bin provides further for the
division of pesticides into general use
3,
-------
-131
pesticides and, restricted use pesticides
o.«oo xhe sale of restricted use pesti-
cides could be limited to certified app'i-
cators who had proven their ability to
use them properly and who face loss of
certification if they use them contrary to
• regulation." 118 CONG. REC. S15894
(September 26, 1972). Moveover, the
'Agency has determined that many acci-
dents occur because of improper trans-,'
portation and storage practices. The re-
striction on sale of these restricted use
pesticides is designed to minimize the
risks from their use. A certified appli-
cator will have established his compe-
tence in proper handling, transportation
and storage techniques.
Many of the objections raised to this
Section were the result of misunder-
standings. The Agency does not intend
to preclude an individual who la properly
certified from following the common
practice of having a third party, who is
propertly instructed as to the correct
manner of storing, handling and trans-
porting the pesticide and who is properly
supervised by the certified applicator,
purchase the restricted use pesticide on
his bahalf. Such activity would be con-
sidered to be within the direct supervi-
sion of the certified applicator. The cer-
tified applicator's spouse, employee or
tenant may be within this class of com-
petent person. Moreover, the regulations "
do not require that a distributor be cer-
tified In order to purchase a restricted
use pesticide from the manufacturer. In
order to clarify this position, the phrase*
"retail sale" has been substituted for the
•word "sale," which had appeared in the
regulations as proposed.
Any product classified for restricted
use may be limited to use by or under the
direct supervision of a certified appli-
cator. Moreover, pursuant to section 3(d)
(1) (C) (11) of the Act and § 162.11(c> (5),
of these regulations, the Administrator
may additionally or alternatively impose
other regulatory restrictions. Several
commenters argued that the regulations
as proposed did not provide for appropri-
ate labeling In the case e, pesticide Is only
restricted pursuant to any other regula-
tory restriction. The language of i 162.10
(JH2H1MB) has accordingly been
amended to clarify that the requirement
for a label statement restricting sale and •
application of a pesticide to certified ap-
plicators, or persons under their direct
supervision, applies only to pesticides
whose registration so restricts them. If
any other regulatory restriction alone is
imposed on the pesticide's use, the Ad- '
mlnistrator will define the appropriate
labeling for the terms of restriction.
Several commenters argued that It Is
overly burdensome to Impose this re-
striction on sale of restricted use pesti-
cides by. October, 1976. They believe that
most applicators will not be certified by
that date. Extensive commitments have
been and are continuing to be made to
the Institution of.e fully operative certi-
fication program. If by 1978, It is evident
that an Insufficient number' of pesticide
applicators have been certified, consid-
eration will be given to amending thess
regulations.
KUliS AND REGULATJONS -
(b) The proposed regulations had pro-
vided that any pesticide for which some
uses are classified for general use and
others for restricted use must be sep-
arately labeled In accordance with speci-
fic i labeling standards, and marketed as
separate products with different regis-
tration numbers, one for the general
use(s) and the other for the restricted
use(s). Several commenters argued that
this provision Is beyond the statutory
authority of the Agency. Section 3(d) (1)
(A) of the Act specifically authorizes the
Administrator to require separate pack-
aging and labeling to distinguish the re-
stricted and the general uses of a pesti-
cide.
The purpose of this section is to prevent
pesticide misuse and accidents in the fu-
ture. In order for the provisions of
§ 1«2.10(J)(?). discussed above, to have
any pracw
-------
132
see. ?(e) (S) asuS (©»; (§)' to
whether to issue notice of
Satsafe to ccacol regtafersaon OF to hold
Kb)); (3) Sa
finaQy to cancel
see. 8(d)): «i) to
di
ess. 8;
<§> ia detamining whether & pes-
should 'tta classified for general OF
usa (FIFRA sac. 3(d) (§)). If
3, the Secretary of. Agricul-
ture's refusal to issue a cancellation no-
tice regarding all registered uses of DDT,
wWc5s TTOuld hsve set the formal admin-
istraSve heggng process in motion. Act=
ing imder. FIFRA prior to: the 1978
amendments,' the Secretory refused to
issue the notice pending further study
of the benefits of file, uses of DDT and &@
fete game determination in essh or these
diffeK-mfe contests, it would be'impos-
sible fo? EFA to perform these distinct
regulatory functions. Moreover, it is in-
eoaesJvabls that the determination
sissdefl to trigger the formal. e.dmlnis=.
teatim, rer?ie^ would be the same as
Qjafe required to make' a final determi-
aattei after such review has basn com-
ths -/determinations required-to apply-
ing &e statutory tesfe- in these different
contests woiaJd vary according' to the
of each different regulatory
f eresst f actors and criteria In determining
"uareasonsble adverse • effects OB the
environment" depending on the specific
regulatory determination involved. Those
factors and criteria which EPA has de-
termined are. relevant, to the particular
determinations pf "unreasonable adverse-
effects on the environment" are con-
tained in 8 182.11. ••/-..
B, Administrative-:anS Judicial Inter"
pretations of t^e^ Statutory. Standard;
In developing the criteria for registra-
tion, classification,- and cancellation,- the
Agency has been guided by the admin-
Ssts&tive and judicial interpretations of
•the basic statutory standard. These in-
terpretations are set" forth in orders is-
sued by ths Administrator in court de-
cisions in review'of.the Administrator's
orders. The Administrator has deter-
~ mined that in applying \ the standard
of- "unreasonable adverse effects" .for
purposes of denial or 'cancellation of.
registration, a .notice- of denial or can-
cellation or notice of Intent to'hold a
hearing to determine whether the regis-
tration should be-denied" or cancelled, as
appropriate, shall be issued when- he
has determined that a substantial ques-
tion of safety exists as to the use or con-
tinued use of the pesticide and that ap-
plicable court decisions require that such
aofclce be issued under these cirqum-
stances. ' "••• .';' /.':-^(: ••-'••'-
The Administrator has further deter-
mined that the regulatory actions speci-
fied -in this 9182.H are in accordance
with his-prior orders and court deci-
sions affirming those orders. The basis;
for these determinations is more- fully
set forth in the following discussion.
~ i. Substantial Question of Safety: $nt-=
Station of the Formal Hearing Process.
In Environmental Defense Fund, Inc. v.
.RuckelsfMUs. 439 .P. 2d 584 (D.C. Cte.
1S?1), hereinafter referred to as SDF. v,
Ritckelshaus, EDF challenged, among
found that use of DDT • .poses. a substan-
tial risfe to mas and the environment,0
The court held that KEFRA required is-
suance -.of .a- cancellation notice' when
there .was a substantial question of safety
regarding continued use of the pesticide.
and that the weighing of benefits against
such ris!s_s&ou!d occur jn a public forum:
blstojy Bupp3Kte>stho. con-
clusloffi that Congress Intended ony oubatas-
tial questloa of acfsSy to telgge? tba issusaco
of ccncQll&feiai& noticSfii, sXiiftlag to tfeQ nioa-.
uf Ednjrs? tao bxKfion oS proving tljo safety ot
nto rtJra • "'"••••'••
.
Fo? ^ajoa CongEta cs?eot«3 a procedure QioS
glvca tfeo pabilc o roto to fiecldlau impo?ton«
qucaiiouD of public jtoliey, tSict pFocednro
may- nofr llgiitly tto-stdeatappod by- tdmlnis-
tentoro. Tno caacaUcStom .fieolflloa dos> aof;
tuzTL oo.-e> sciozitl^e G£s@^i&ozit pf lu^^s^
ciono. Tno statute loovea room to b&Iancs tho
of. e, pesticide Bgaiast Its riaSfl. Tno
. is d, dolloata one, in ?7bicb gre&tsr
should ,b3 £ccorde .
*> Environmental Defense Fund v-. En-
vironmental Protection Agency, 510 F.2d 1292
(D.C. Cir. 197S), Dow Chemical Co. v. Ruc-
kelsfiaus. 477 F3d 1317, 1319 (8th Clr. 1973) \:
Environmental Defense Fund v. Environ-
mental Protection Agency. 465 P.2d 528, 533
(D.C. Cte. 1972); Steeffns "Electric Paste Co-.
v. Environmental Protection' Agency, 426
P.2d 293. 307 (7th Clr. 1972); Wellford v.
Ruckelshaus,-*£$ P^d 598, 601 (D.C. Clr.
KSSSJflE OS6ISTK1, VQi.
. 129 — THUBS9AV,
-------
,133
..ceUatiori proceedings where the only
standard "for'the issuance of cancella-
tion nonces"' Is- "substantial question of
safcgy.".4«&H2ei afc 533. '.--• '
'-" Accordingly,. to cases arising • under
prior to toe 1972. amendments,.
courts have uniformly held that
a substantial question of safety-
.' as to ose of & pesticide is found to exist, •
• provision must be made for em oppor-
tunity for balancing the- risks against
' the- benefits of- use of the .pesticide in
B-'pnblic hearing. •
Tne legislative history states that the
effect of these decisions under the pre-
1372 statute is not changed by the 1972
amendments, but rather is incorporated
to the revised statute. The Seriate Com-
mittee on Agriculture and Forestry stated
in Its report on the 1972 amendments •
to FIFRA that the amendments "carry
forward". existing law: notice of Ixxtenfc
to cancel registration must be Issued
"where a substantial question of safety
. exists." Senate Committee on Agriculfcure-
and Forestry, S. Rep. No. 92-838, 92<£
Cong. 2d Sess. 12-13 (1972); See also
•- Committee of Conference, Federal Exryl«
~ronmental Pesticide Control Act,, S. Hep..
Kb. 92-1540. 92d Cong. 2d'Sess. 32 (1972)
(."tthe amended"FIFRA3 preserrcs can- .
cellation criteria in existing' law*0), •
This view has also recognized in the
•adoption of section 16 (a) of the amended
FIFRA-which provides that the decision
.to register or not to cancel registration
shall be reviewable in district court where
a trial de nova would be conducted solely
to determine whether a substantial ques-
tion of safety existed. The Senate Agrt- .
culture Committee Report on section
18(a) stated that: ''••-.-
Whera, however, the Administrator has de-
termined no substantial, question of safety
exists which wcfrsnta formal review,' and
thus has refused to bold a hearing, review
should be by a district court since there Is no
record for the court of appeals. I&. at 13.
Thus, under the 1972 amendments,
Congress intended that "unreasonable
. adverse effects" as applied to the issuance-
of denial'and cancellation notices would
be determined by the presence of & "sub-
' stantlal question of safety." As applied
to a decision finally to deny or cancel
registration, the- determination of "un-'
reasonable adverse effects" would include,
in addition, a balancing of risks and.
benefits. .
In its April 4, 1975 decision affirming
the Administrator's order suspending
registrations of Aldrln and Dieldrin, the
United States Court of Appeals for the
District of Columbia Circuit reiterated
m Environmental Defense Fund v. Envi-
ronmental Protection Agensy, 510 P. 2d
1232 (1975), that the "substantial ques-
tion of. safety" test remains the basis for
Issuing a notice of Intent to cancel or
deny registration under the provisions of
the 1972 amendments to FIFRA. 510 F.2d-
at 1296. n 4. Citing the 1972 amendments.
to FIFRA. the Court emphasized its ear-
lier holding In EOF v. Ruchelshaus, supra
(1972) that -" ° ° FIFRA requires the
Secretary to Issue cancellation notices
and thereby initiate the administrative
process whenever there is a substantial
question about the safety of a registered
pesticide." IS. -
Where a substantial question of safety
is found to exist, the regulations provide,
in accordance with Court decisions and
legislative intent, that a notice of intent'
to- deny registration, a notice, of. intent
to cancel registration, or a notice of in-
tent, to hold & hearing to determine.
•whether the registration should be can-
celled or denied, must be issued. Follow-
ing issuance of the notice and convening
of a hearing, the regulations provide. In
accordance with court decisions and leg-
islative • intent, an opportunity for the
risks and ben??!ts from use of the pesti-
cide to bs fully considered and weighed
ia & ponlic forum." •
KEFRA makes a" procedural distinc-
tion between denials of registration and
canut-tujtion ' registration. Is the case
of a new application for registration, the •
Administratoi ~"*y grant or deny regls~
{ration. The effect of denial Is to prevent
the pesticide from being introduced into
commerce until administrative pro-
cedures—such as .section 3(c)(6) hearr
lags—have been'exhausted. In'the case
of. an erisfthng registration.- however, the
Admioisfcraioir ssay either. continue the
registration:-or cenceJ the registration.
Unless the registrant fails to request a
hearing, within 30 days, of the initial
cancellation order, cancelled registra-
tions remain In full force and effect until
after a decision has been reached on the
record by the Administrative Law Judge,
and by the Administrator if the case is
appealed to him.
Because of these Inherent differences
in. the statutory' procedures for- denial
and for cancellation, which allow COEL-
tinued use of cancelled pesticides pend-
ing a final decision following an admin-
istrative hearing, FIFRA also provides
for accelerated procedures with respect
.to cancelled pesticides. In accordance
with FIFRA section 6(c), where the Ad-
ministrator finds that "action is neces-
sary to prevent an imminent hazard
during the time required for cancellation
or change in classification proceedings
.° ° °" he may by order suspend the
registration after providing an oppor-
tunity for an expedited- hearing on the
question of "whether an imminent haz-
ard exists."
In addition, where he finds that such
an Imminent hazard exists, the Adminis-
trator may issue an emergency order sus-
pending registration effective immedi-
ately pending completion of the expe-
dited suspension hearing'.- The term
n Prior to the 1072 amendments. FIFRA
did not explicitly require th&& the risks
(costs) and benefits of use be balanced In
finally determining the registration or can-
cellation of pesticides. .However, es the Ad-
ministrator noted in the DDT order, the
balancing test bad long been established.
"Both judicial and administrative precedent
recognlza that Congress intended the appli-
cation of & balancing test, that would meas-
ure the risks of using a particular chemical
against its benefits." Order. Consolidated
DDT Hearings, Opinion and Order of the
Administrator, 37 FB 13369 (July ?, 1872).
"imminent hazard" is defined by FIFRA.
section 2(1) to mean "a situation which.
exists when the continued use- of a,pesti_-
cide during the time required for cancel-
lation proceeding(s) would be likely to
result In unreasonable adverse effects_on
the environment or will involve unrea- '
-sonable hazard to- the survival, of a spe-
cies declared. endangered by the Sec re*
tary of Interior under Pub. L. 91-135."
Thus, the statutory test of unreason-
able adverse effects which applies to de-
nials of registration and to cancellations
also applies to suspensions, and, before
a suspension order may be issued, the
cancellation, process must have been ini-
tiated. Section. 6(c)(l>. Therefore, the
regulations do- not set forth procedures
governing suspension but it is appro-
priate briefly to set forth recent case law
which will guide the Agency's determina-
tion as to the presence- of an! "imminen.tr
hazard." ' _r-
• The courts have repeatedly "cautioned
that the term 'imminent-hazard' is- not
limited to a concept of crisis: 'It Is
enough if there is -substantial likelihood
that serious harm .-will be experienced
during toe year or two -required In any
'realistic projection of the administrative .
(cancellation) process.'." Environmental
Defense Fun&^Inc. jr. Environmental Pro-
tection, Agency, 510 F.2d at 1297 (D.C.
Cir. 1975). (Emphasis In original) quot-
ing from -Environmental Defense Fund,
Inc. v. Environmental Protection Agency.
465 R2d at 540 (D.C. Clr. 1972). Of
• course, as in the cancellation proceeding,
the Administrator-does not have the bur-
den of proving that a pesticide is unsafe
since the statute and case law place
"ttlhe burden of establishing the safety
of a product requisite for compliance with
the labelling requirements ° ° ° at all
times on the applicant and registrant^'
EOF v. EPA, 510 F.2d at. 1297 (D.C. Cir.
1975); EOF V. EPA,-4e& F.2d at 540 (D.C.
Cir. 1972). .-"- _• ~. ._.--• •'•
The courts have consistently held-that
"the function of. the suspension decision
Is to make a preliminary assessment of
evidence and probabilities, not an. ulti-
mate resolution of difficult issues. We
cannot accept the proposition. ° ° ° that
• the Administrator's findings [are) insuf-
ficient because controverted by respecta-
ble scientific authority. It CisI enough
that the administrative record contain
-respectable scientific authority support-"
-ing-the Administrator." EDF v. EPA, 510
F.2d at 1298 (D.C. Cir. 1975); EOF 7.
EPA. 465 F.2d at 537 (D.C. Clr 1972).
The courts have distinguished between
cancellation and suspension by requiring
that cancellation notices Issue whenever
there Is a substantial question of safety
and defer thorough consideration of
benefits to the public forum, whereas In
the case of suspension, "the statute em-
powers the Administrator to take account
of benefits or their absence as affecting
imminency of hazard." EOF v. EPA, 465
F. 2d at 538 (D.C. Cir. 1972). Accord-
ingly, within the constraints Imposed by
FIFRA- and by case' law as explained
briefly below, the Agency intends to con-
tinue evaluating the need for suspen—
slon by taking into account, upon lssu°
FEDESAl BSaiSTEB, VQt 40, NO. !29—THUSSDAY, -JUUf 3, 197S,
-------
134
eaca of a aoQeo- of lafeaafe to cancel In ac-
eordEaeo wifc& thesa "resulatioas,,"" risfes .
and feeaefits of use, the expected length
of any csacellatJoa proceedings; any rel-,
evaat manufacture, distributing, or uss
,£ycle; and: any other pertinent factors.
2. 5*1208 cancellation of deals! pro-
ceeding bsesuso of "unreasonable ad-
versa eSects oa the environment" and
for issuing Snal orders In such proceed-
lags, ths Administrator has been guided.
by the ssaerai principles and policies de-
veloped in previous cancellation and sus-
pozisioa proceedings which, have- been..
sfflrmed by United States Courte of Ap~
psa&cide because of environ^ '
mental and human health risks waSy&iQ
essaesllaaoa of DDT. which- waa finally
decided by the Admialstrator on. Juae 14,
IfflZ *> ead subsequently aStemed by. the
United Stalss Court of Appeals for" toe
•District of Columbia Circuit on Decem-
ber 13, M73.10 : ,' . •••"•"•
la finding, that DDT should bs can- .
celled, the Administrator applied several
general principles and policies which. .
have also been applied in other proceed-
ings "and ere adopted in these regula-
tioas. Mrst, ia pw^ng the risks of ttea
use 'of a pesticide, both short- term.' and
long-term effects on man. and other-
organisms must be determined* and con-
sidered. ' - '
Second, the actual observations, of
Ions-term, chronic . effects, particularly
' OH man through epidemiological studies,
are of limited value in determining' the
restoteaBilifcy of a pesticide; since ones.
the effects are actually observed ia maa "
or the - environment, - the harm - has
already occurred and may be Irreversl-.
bl®.- Therefore. extrapolation" from Iabo= .
ratory studies oa 'animals must be util-
ized to assess risks to man or the en-
vironment. As th& Administrator, stated.
ia fee Order: . ;•'. •••• -~.;I
X6 ia pcarilcutesiy difficult to anticipate the
long-rQngo offccto c2 exposure to a lo^7 dcso-
of o chemical. IS may te&Q many yecss ba=-
f csra efive^Ep eSectei YTOulti teto plcco. Disscsoo
JlSo cancer hovo ca extended latency. Bfluto=
eSeeto will ba apparent only in fuSu^o
Scatty. K msy bo ImpcaslblQ to
obsesved. patSiolosy in mca to p=s- '
cJiemJecl bocauco cuf^tbo Inability ta>
coateol B^nsp3 wMcSs.xc?3
Administrator's decision the Court em-
phasized the expertise of ins Agency to.
health risks of the use of chemicals and
elusions reached by EPA even la the face
of convicting scientific opinioa.
.° -°' ° W12 EB'ff (SOUS* CSO COnfeOffltStJ'^ltSi D
.problem In cdmlnistratl7G> ICTT, not In chom-
'istey, blptogyr mctitclno, os ecology. Kt is tho
cdmintDtsotSvo cgoney wnlcb oao bean ceiled
upon, to besf cad o^cluoto testimony In oil
ooloatlflo flolcJo relevant to Ito ultimata ques-
tion o? parmlaaion of ptonlbltlon o>£ tbs ssslo-
Ml (2 UEO of DOT. Tuo EPA Admlalsteatoj hcd
£ja- O2>p3?tttnity to- mcio e, ccjoful study of
tbo rscoM of Savon montns of public heaslngs-
ca<2 t2iD summc^les of evldonco prepersd fa?
him. hocjti orai.&rgumQnt, cad not? nes- 1?-
rtvefi c,t c docislon to ban most uc£j of DDT.
£t la Mo decision .wnlea wo must
th& Court held that the
use of laboratory data, general data, and
rseogaittoa of the/iahereafe. chemical
characteristics of pesticides were suffi-
cient; as a meter oflaw to. determine thafe
a pesticide should not be registered.
la ao acmo fis3SB5> os tho-rest of tSa popu-
' ' ' ' "
on gsnesal ^^dato, consldeBotlon of
on fvaitwA
& oufflciania basis to ouppffri;
tos^3 fladlags, e?on "Crtta ragoiti to
apeclzi tzso ofDDT, M. E* i286. - ' - .-• - >
. FurSiermore, the Court held that the
Administrator, was not required to deter-
mine aad balance the risks and benefits
of each specific use of a pesticide to de-
termine that "the use [of a pesticide] in
.general is hazardous" and therefore can-
not ba registered or continue to be
registered." v • ' • ' ' - ' •'. ~ ' - ^
The general principles. and policies ^et
forth in the DDT cancellation opinioa
and order recently were applied and ex-
panded ia the decision of the Adminis-
trator to suspend virtually aiLuses of the
pesticides Aldrin and Dieldrla.10 As in
the CESQ of the .decision to cancel DDT,
. the decision to suspend Aldria aad
Dieldrla was based oa several years of
administrative inquiry into the risks of
Aldria and Dieldnn end maay months
-of cancellation hearings, evidence of
which was incorporated into the suspen-
.sioa| bearing: The Administrator's opia-
.ion, which Considered and was preceded
'by aa extensive recommended decision
by the Chief Administrative Law Judge "
who presided during Si© cancellation
Oa Dccexaks- 13,. 1973, the United
States Court; oS Appeals for the District
o£ GoJumbi£> affirmed the Adminlstestof'o
ogeaie stek of Aldrfa aad DieldrJa.' Be=
fore decidia? whe&er &ere wss • suffl-
eieat evidence to Sad a carcinogenic risk
supported by "substantial
0 Moreover, in reviewing ths
end O?£c? of £JlD
(D.C. Cte.
K Cs
13374-
SeoringD. Opinioa
't 37 FH, 13369
'. Environ*-
P. S& 134,7
, tmjsre, fcotnoto 19
111 Shaft Cnomied Compoay, ofe ci., Opinioa.
.onfi Osdcc? c£ ^io Adminl£7te&to?, 30 5® 37263
(Ocfe. 18, 1S7<1). . -
did rto-S osjjllcsay adoyS -Sio findings
"Is cicca-ly ImpUclt in cad Indcsd soffuesa nio
' [tho
from Aldrifl and Dieldrln, the Adminis-
trator, as did the Administrative Law
Judge in his recommended decision, set
forth the general theories for evaluating
the carcinogenicify evidence on Aldrin
and Dieldrin. First, the- Admlnlstratrr
affirmed the scientific validity and. ad-
ministrative necessity of using ezperi-.
aSental animal. data in evaluating the
risks pesticides pose to man and the en-
vironment.10 Second, as in the DDT Or-
-der, he rejected the notion that in the
face of positive laboratory data of car-
cinogenicity, regulatory decisions which
will directly affect the public health
must be'deferred-pending completion of
epidemiologlcal studies, which require
many years and in any event provide
- data for making public health decisions.'
. only after the public health may have
"been irreversibly Jeopardized. Third., the
Administrator questioned the results, of
epidemiological studies where, the chem-
ical is-environmentally ubiquitous and all .
populations have received chronic, expo-1'
sure.10 Fourth, the Administrator rejected
the distinction between "benign" and
'.•malignant" tumors and "tumorogenlc"
aad "carcinogenic substances" for pur-
poses of hazard evaluation because of
"the increasing evidence that many tu-
mors -can develop into cancers." He
• determined that' "for purposes of carcin-
. ogenicity testing, they should be consid-
ered synonymous." ° Finally, the Admin-
istrator agreed with the finding of the
Administrative Law Judge that no safe
level of exposure could be set for the
pesticides Aldrin- aad Dleldrin which had
beea demonstrated to be carcinogenic in
a.rtimgjB, even at very low levels. Accord-
ingly, the Administrator concluded that
"a substance that will induce cancer in
experimental ajnimaJg at any dose level,
no matter how high or. low, should be
treated wltax great caution,"01 • ,
Oa April 4,-1975, the Court of Appeals
_fcs> the District of Columbia in Enmron-
menial Defense Fund v. Environmental
Protection Agency, 510 P. 2d 1292, af-
firmed, the Administrator's Order and
Opinion. The Court upheld the Adminis-
trator's findings and policies set forth
above as being 'within the expertise of.
the Agency. Specifically the Court stated:.
Too 'Admlnlste-atop'Q feiluro to determine a
thfeancid level of exposure to aldrtn/dleldrln.
dc33 not. render Ms determination Improper,
tas no lias! concluded tho& tha concept of &
thrsanold exposure level h&s no prectlcea alg-
nluc&nca TThera ccffdnogoaa ore concerned.
Tnla lo due in part to the Irreverslbllity and,
long latency period oS ccJrdnogenfl. ."[W]bere
tho matter Involved Is eo csnsltive &nd fnght-
i iBden ca cancer," end tlio statute- places the
. bwdoa on the registrant to estabUsh the
ocfciy oS his product, WQ shall not, assuming
a ErabtrtoattcJ ethoxTlng of' dcnge?, require the
Admlntetestag to m&&e Impossible proofs. In
810 P.-
mcato ospllsiS.13 BBi? v.
06-1803. (3.0. Gte. 1978).
0,6 37270. ' : •. ~ ;
i principles were recently reaffirmed
by tho Admini££rato? In hio decision to den;
tho State o£ Louisiana's request fo? emo?-
geney uso of DDT 03 eottoo. Sso,
of Iteesom for Xten,is& oat
££e£ens<3ft£,'40 FS ISBSC (April C, 1978).
13 ftS.eS 37287 • .
V@L. 4®F-.
-------
reviewing administrative actions, courts
."cannot fairly demand the perfect at the
' ospsncs ot the achievable." The Admlnlatra--
tor'o • conclusion In within too scientific es-
pertlao of the agency, and Is not Infected by .
orror of law. Compare Environmental Defense
•Fund,, Inc., v. Ruckelihaus, supra, .143 U:S.
'App. D.O. at 88. 438 F. 3d a* 888.
. The validity of. extrapolation to humans
'from date, derived from testa on gvolmftlB Is
also c,.matter within the agency's expertise.'
' There traa testimony before the Administra-
tor to, support such extrapolation, end this
court has acknowledged the significance of
test animal data when cancer la Involved.
Use of tvnimai data Is particularly appropriate
where, as here, accurate epidemiologies!
studies cannot be conducted because tho vir-
tually universal euntcuJuluat'Cu c« huz£££is ^?y
residues of aldrln/dleldrln make It Impossible
to establish an uncontamlnated human con-
trol group. The long latency period of carcino-
gens further hinders epldemlojoglcei re-
search, and the ethical problems of conduct-
ing cancer experiments on human brings are
too obvious to require discussion. Although.
extrapolation of date, from mice to men may
bo quantitatively Imprecise, It Is sufficient
to establish a "substantial likelihood" that;
harm will result. [Citations omitted]. Id. at
... 1298-1299.™
:-•? '..Rnally, the Court aflu-med the Admih-
~ istrator's balancing of the- risks and
'. benefits of the use of Aldrin and Dieldrin •
in- his decision to suspend, noting- that if:'
the EPA suspends, as in the case of Al-
drin and Dieldrin, the burden is on the
proponent of registration "to establish
that continued registration poses no safe-
ty threat" or "that the benefits outweigh
the risks," Id. at 1302.
In accordance with the principles of
hazard evaluation in the exhaustive DDT
- and Aldrin/Dieldrin administrative and
court proceedings, the use of animal tesfe^
. data is the foundation for hazard evalua-"'
tion criteria for new and old pesticide
products. Such data, are used to evaluate
both the short term and the long term
effects from the use of a pesticide; there-
fore, in § 162.11, both acute and.chronic
effects criteria are set forth. The hazard
of acute effects, as is explained below,
• generally can be quantified on a com-
parative scale. The hazard of chronic
effects, however-. Is generally not subject
to precise quantification and must be
evaluated as part of a qualitative assess-
- ment of risk. In the following' sections,
the specific criteria for assessing both'
acute and chronic effects and the ration-
ale for the selection of specific criterion
are set forth.. As explained below, these
criteria serve as initial hazard indicators
which set more formal procedures in mo-
tion to determine classification, registra-
tion and cancellation. The criteria do not
impose additional data, requirements.
Data requirements are set forth in i 162.8
and the corresponding sections of the
Registration Guidelines.
C. Acute Toxicity Criteria. Several
commenters questioned the propriety of
utilizing numerical toxicity criteria as
- : . 135 '
KUIES-AND REGULATIONS .
hazard Indicators for the dual purpose of
determining whether, as an Initial mat-"
tar. a pesticide should be classified for
general or restricted use and whether e
pesticide la subject to a rebuttable pre-
sumption -against registration or con-
tinued registration. For the reasons sefe
forth below, the Administrator has deter-
mined that such toxicity criteria are valid
indicators' of presumptive'hazard and
serve the important regulator? function
.of screening those pesticides which re-
quire additional scrutiny to determine
whether they should be registered or, if
registered, whether they should be classi-
fied for general or restricted use. As dis-
cussed below. Qie. particular numerical
criteria employed vary according to the
anticipated rats of exposure, type of use.
and anticipated hazard. -
1. Existing Numerical Criteria. Numer-
ical coJdcity -ritcria • have, of course,
been used In this country and abroad.
as indicators t° hazard for many >ears.
ta 1949 Hodge devised a numerical scale
in which chemicals were classified into
groups categorized by simple descriptive
phrases—"extremely tosic," "highly tox-
ic," "moderately toxic," etc.—using the
oral LDu as the numerical criterion for
• .categorization.01-This scale was- subse-
quently modified by Gosselin to apply to
'formulations rather than technical
chemicals with the object of'preventing
poisoning, since the formulated product
had wider distribution and exposure than
the technical material. Gosselln's scale
was .further modified and expanded by
inclusion of numerical criteria (LD» or
IiCuo) representing dermal and inhala-
tion toxicity and formed the basis-.'of'
regulatory interpretations under the
1947 FIPRA, to determine the warning
(signal) words and precautionary state-
ments required to. appear on, a product
label." . ,....
' a. Use of existing toxicity categories
for. precautionary labeling. This same
method-is used for determining the ap-
propriate signal word and precautionary
statement for labeling purposes under
these regulations, although some mod-
ifications have been made to the inhala-
tion and skin and eye irritation criteria.
.Thus, numerical toxicity categories are
established for formulated products
based on dermal, inhalation, and oral
LDm or LCs» values; and qualitative de-
scriptors are used to evaluate skin and
eye effects. For instance, if a particular
formulation has a dermal LDs> of 200
mg/kg or less, it falls into the highest
a The Court also affirmed the Administra-
tor's use of mica date, la assessing the- car-
cinogenic hazard of Aldrln end Dleldrln de-
spite strenuous objection by the petitioners
that mlco ore not valid Indicators of human
carcinogens.
13 Hodge, H. C. and J. H. Sterner, Tabula-
tion of Toxicity Classes, 10 AMER. INDTJSTR.
HYO. ASSOC. Quart., 93-93 (1949).
K For a discussion of history and develop-
ment of the LDa> test, see Principles and, Pro-
cedures for Evaluating the Toxicity of House-
hold Products, NATIONAL ACADEMY OP
SCIENCES—NATIONAL RESEARCH COUN-
CIL. Publication 1138 (1964). and Loomls.
Ted A., • Essentials of Toxicology, LEA 6
FEBIGER, Philadelphia (1968). The value
obtained for the LDs> from an experiment
with a unite number of test animals Is on o
statistical basis, an estimate of the actual
tioso required to bill 50% of an exposed pop-
ulation.
toxicity-category- and'must bear on Its
label the signal word, '"Danger," and the
precautionary statement, "Fatal (Poi-
sonous) if absorbed through skin DO not
breathe dust [vapor or spray mlstl. Do
not get In eyes, on skin or on clothing."
In addition, the label must bear a state-
ment of practical treatment on the front
panel. See § 162.10(1): Pew commenters
questioned the continuation of this sys-
tem, as modified, for labeling determina-
tions . " • • •• •'•'"'
b. Existing toxicity categories for ci&s-"
sificdtion of pesticides. In enacting the
comprehensive 1972 amendments to
. FTFRA, Congress recognized that these
long-standing label requirements had not
been adequate, stariSing alone, to pro-
tect the pesticide user or other persons
from the adverse effects of exposure to
acutely toxic pesticides. Accordingly, sec-
tion 3(d) of the amended Act directs the
Administrator to classify -pesticides
either for general use or for restricted
use. Pesticides classified for. restricted use
will be restricted to use by certified ap- "
plicators or subject- to other regulatory
restrictions. '-.*?•'••
.... Section 3(d) (1)'.(C)(i) of the Act
'specifically requires the Administrator to
restrict a pesticide's use to certified ap-
plicators U the pesticide Is classified for
restricted use based'on its acute dermal
or inhalation toxicity. As discussed above,
the.established method for determining
acute toxicity is based upon laboratory
procedures that establish doses lethal to
50% of the test animals This method
was utilized prior to the 1972 amend-
ments to protect the user through label-.-
ing. Accordingly, the Administrator con-
cluded that it was reasonable to apply the
same system, including equivalent nu-
merical criteria, when determining as an
initial matter that a pesticide was too
hazardous to be classified for general use.
Established as hazard indicators, the
toxicity categories serve expressly that
function in the classification scheme by
acting as an initial screen for classifica-
tion. An applicant, however, as discussed
elsewhere in this preamble, is provided
the opportunity to demonstrate to-the
Administrator that a pesticide which
meets the toxicity criteria for restricted
use should nevertheless be classified for
general use because its labeling, formula-
tion, packaging-, or method of use could
reasonably be expected to minimize-the
likelihood of hazard.
The classification scheme is further re-
fined in that more stringent criteria are
set for pesticides registered for domeEtlo
use (in and around homes and certain
areas of educational and health related
institutions) than for non-domestic use.
Specifically, If a pesticide formulation
intended for domestic use falls into tox-
icity category I or H, it is considered a
candidate for restricted use: if the for-
mulation is intended for non-domestic
use, it is considered a candidate for re-
stricted use if its dermal or inhalation
toxicity or skin or eye effects places it in
toxicity category I. These toxicity cate-
gories are used explicit? in § 162.11 (c) (2)
which specifies criteria for classifying
pesticides for reregistration. The sama
Q56ISTES, VO!. 40, NO. 129—THURSDAY, JULY 3, 1975
-------
. criteria are used if * l'3:"(c) U) which
specifies criteria for clamrfylng newly reg-
istered pestidde*, Further protection to
the user Is provided by classification cri-
' terta in these sections based on chronic
' or delayed toxic-effects, discussed infra,
-and by »18341(0, (3) and (4> which
require consideration; of adequacy of la-
~ baling, use history., accident data, and
other appropriate factors.
~ 3. Additional Numerical Criteria for
• Protection Against Hazards-not covered.
by Existing Categorisation. The UX and
LCo criteria used to define the toxicity
categories are. the experimental values.
determined for the formulated product.
The degree of acute toxicity of the for-
- - .mulated product Is determined in order
tor protect users from accidental exposure
. during handling and storage. However.
•. .human exposure to pesticides also occurs
•during and after application of the pesti-
cide!. These activities Involve.. In. many
cases, the application.of. a substance that.
has- been diluted .from a concentrated
formulation. Therefore, to protect appli-
cators and other exposed persons, Inelud-
"-- ing children, .from hazardous exposure-to.
\ pesticides during and after use. It is nec-
essary to-apply munerical criteria based
on thetoxteitiy of the pesticide a* diluted
• for use. Depending .on the degree of dihiT-
, -tion, suoh criteria*'may be more-. OP less
stringent than those Imposed on the
formulated product. In addition; three
criteria have been Included for pesticides
Intended for outdoor application to pror
''"• tect" against hazards to wildlife. TJiecri-
'„- teria are based on the amount of active
.'ingredient which will remain after the
•"... application of the use diluted product. :
'•:•• Three' steps are involved In the. setting
' :.of these numerical criteria: (1) determi-
. ! nation of the principal types of exposure
'. which pose hazards; (11) estimation of
* exposure levels encountered under condl^
. • tions of use of the- product or of similar
'products; and (ill), application-of a-safety
"'"*"' factor to provide a margin of safety for
individuals 'exposed to these levels. .
....-The purpose of the following, discus-
sion is to explore each one of these steps
in detail in order fully to.explain the
Agency's choice as to a particular num-
~ber. The discussion Immediately below
~ sets forth general principles of exposure
to acutely toxic pesticides and describes
the anticipated hazard of-such exposure
-- , "as developed from field surveys and nu-y
-nacrous publications. The next section
discusses the selection of appropriate
safety factors to address the anticipated-
hazard. '•"• .;•'- .-" • •-... — -;-.-
The final section explains the Agency's
choice of criteria. Including an explana-
tion of why, in a particular case, the gen-
's«ral principles of exposure, hazard, and
^- Election of safety facts were or were'not
••utilized. • .
exposure posing- denum-
136
RULES AND REGULATIONS
eral use. Published surveys " suggest that
pesticide poisonings constitute a signifi-
cant amount of aU chemical poisonings
in the tfaited States- and that most In-
cidents of human poisonings by pesticides
fall into one of two categories: pr><««r>Tri»m»
.with, pesticide applicators experiencing
. the highest rate and manufacturing
workers experiencing the least number.1*
These estimates have not been corrobo-
rated by the Agency; however, we have
determined that they Indicate the scope
. of the hazard arising from pesticide use.
In. the case of wildlife, • most docu-
mented/cases of substantial Immediate'
-damage1 refer to poisoning of ™Mtmmi«
and birds feeding on contaminated food
-or on treated baits, or to kills of fish and
other aquatic .organisms resulting from
-contamination of shallow waters." Tox-
* Report of the Secretary?* Commission of
Pesticides and their Relationship to Environ-
mental Health, UJ& DEFT. HEALTH. EDUCA-
TION. AND- WELPAHB, 304-319 - (December
1969); Davlea, J. B,-«t ai. Epidemiology and
Chemical Diagnosis . of Organophosphate
Poisoning, In "Pesticide Symposium" (W. B.
Deichmann and J. L. RadoTOfcl, eda)." tad.
'MediPnWlsmnff Co., Miami (1969), Lande. 3.
.a. An Epidemiological Study of Pesticide Ex.-
potura in Allegheny County, Pennsylvania,
29 ARCH, ENVIHeN. HEALTH, 9O-9» (1974).
Hayes, W. JU Pesticides and Human Toxic-
ity, 160 ANN..N.T. ,ACAD. SCI,. 40 (1969).
Hayes, W. J-, Epidemiology and General Man-
agement of Poisoning by Pesticides, 17 PEDI-
ATRIC CLINIO8 OP WORTH AMERICA, .639
(1970>-..L1seU*, F.^S..- Epidemiology of Poison-
ing try Chemicals, 34 JOURNAL OP ENVTB.
HEALTH. 603 (1973); and Whtttocr, N. W,.
Keil. J. E.. and Sandtter, 3. H, Pesticide Mor-
bidity in South Carolina, Revisited, 88 JOUR-
NAL OP THE SOUTH CAROLINA MEDICAL
ASSN, 109 (1973).. .. ^^ • ".
"Hayea, Pesticides 'and Human Toxicity,
supra 40-45. .Hayes: reports that,-ror Cali-
fomls. one of tow statee wltlt' a mandatory
accident reporting system, pesticide work'
Injuries for 1960-63 ranged from 837rl,013.
For the same period approximately 20 per-
cent of tne deaths caused by pesticides oc-
curred from occupational exposure. For the
period 1964-67. California had reported an
pnmmi average of 1400 occupational poison-
ings, Hayes. Epidemiology and General Man-
agement of • Poisoning by Pesticides, supra
•ftt 634. • • •'..-;' :••- ..--• '.-:-.
"Report of the.Secretary's Commission on
Pesticides and their Relationship- to Envi-
ronmental Health, UJS. DEFT. OP HEALTH,
• EDUCATION, AND WELFARE (Dee. 1969) pp.
177-323. ... . -.'- .- .;.- .- - ::..
Icity to nontarget insects and other
beneficial invertebrates is often of sig-
nificance " but is difficult to prevent by
mean* of classification.
b. Estimating exposure levels lor crit-
ical types of exposure. The most impor-
tant determination -for assessing the
hazard posed by an acutely toxic pesti-
cide is the estimated exposure level
likely to result from normal use. If that
level Is sufficient to produce an adverse
effect, exposure must be limited through
Improved application techniques and the
use of. protective clothing, and- other
proper safety procedures. Even the most
acutely toxic pesticide can probably be
used-safely if the applicator follows
proper use and safety procedures to
avoid a hazardous exposure. Conversely.
a dose of a much less acutely toxic pesti-
cide can result in severe injury through
avoidable accident or Improper negli-
gent application techniques and proce-
dures. In amending the Act, Congress
found that substantial numbers of users
of pesticides did not follow label direc-
tion* and overused and misused pesti-
cides. Congress, through Section 4. of the
amended Act, addressed these problems
by requiring that only applicators who--
have demonstrated competence be al-
lowed to use acutely toxic pesticides. Ap-
plicators can be certified under the pro-
- visions of Section 4 if they have dem-
. onstrated their competence to use acutely
toxic pesticides safely by avoiding dan-
gerous exposure to themselves and other
nontarget organlsms^Accordingly, in de-
termining the classification criteria for
acute toxlclty. It is essential that EPA
estimate the amount of exposure likely
to be experienced by both the applicator
and by other persons, inriiirfing by-
standers and children, as a consequence
of. Improper application. If .the exposure
levels would result in toxic doses or doses
that have unreasonably small 'margins
. of safety, the pesticide should be clas-
sified for restricted use. . *
The .exposure an applicator will re-
ceive in handling or applying a pesticide
or the exposure any Individual -wfll re-
' ceive as a result of the pesticide's appli-
cation can then be related to the LCM
and- LD» doses obtained In laboratory
experiments to determine the approxi-_
mate .danger associated with that level
of exposure. Exposure during, applica-
tion Is largely to the product as diluted
for .use. Accordingly, the use-dilution
LDn'has been added as a classification
- screening measure* The numerical cri-
x terion is computed! as explained below:
.-
FEDSUL REGISTER; .VOt, 40.-NO. 129—THURSDAY, JULY 3, 1975
-------
•.:.•-$.'•:*?:•£.'•
..*'' -- ~.'&-r"f .. i -
2 others, Wolfe et eL° tabu-
•Xatsd over 8© esposure studies involving
more -Siaa-. S.OOO measurements of 232-
posoru to. 23 •> psUclde chemicals in s
vasie^ of-formulafetoas and under., e,
vmriety .of- methods of application. .Sa.
msnfe sgadies tha dermal and. respiratory
- esposures te -th©
-measured.- ead. ths -use. d&uttaa. was
'.sfefeaL K;sii oT~th© active-ingredienfe as
^measured by-Wolfe, e& eL was esssKsefi
':• to bs residues of 'the use-dflutEd product
'Si«& tha-raM© of the residue to the dita.=
tioa rat© would give an accurate meas-^.
TTXTQ of exposure to the use-diluted prod-
;:acfe;-ZS fast, hc~sver, the, measured
"aefive. ingredient, residue resulted from
:: total exposure, to • the applicator from
Bofeh exposure to the use-diluted peoducfe
sad th® formulated product. "Hierefore,.
-:-£he ratio of active ingredient residuQ to
-dilution rate- overestimates the- -amounfe
-o£- exposure attributable to the use-di=
Iratsd producfe, Thus, a facto:? is included
.-amount of total exposure arising soleSy
• feoHs application-- of the us©~ditat2d
proiaefe, Th© espoaure- - studies cifeed
-•aSsovo do sot include date, necessary fosr
;'eomputisg-. this • factor.: However, based
- os.. feaowiedge: of. . the . es&vJSea •
•were esaZysed' tar- the expssu
iis value Js esSmated to b® two.12 The
rat£s of measured exposure to the use-
diluted producfe. were then computed.
according to the following equation:
• •_." - - ^" sa "...- -.T-' _'•"•'.
• . . - - -B>X10-° '-'-' •_•-: • ' .
where E = exposure rato to 6aa uso-filSuted.
-' -• ' ' • produce (mg/Sir) . . .,.
."•-•"•? a.'= rato o£ dilution (%) '• ' -~ • '
'.'•• S2 = measured vsluo of exposure pats
:"'-" , -.- . "to ootiTO- IngrodJeng •
Por outdoor spray applications, most- of
' the dermal exposures measured by Wolfe
e£ cl. and computed by the above equa-
tion fell into the range 3-50 g/hr.; cal-
eulaisd sis the rate of deposition of the
'diluted product .falling on the. skin, of
\ o Wolfe. E. K,. W. Durham, KS& 3. F.
dtesag. Exposure} of-iaorlcers to pssUddea.
AKCH." ENV3ROU. EESLTE, 822
Wotfo, H. B^ 3. P: Armsteong. D. C.
oafi a. W. Comor, Exposure o/
p2s«to4 *In&o&? esftoswre. Far. fewer data,
• are available ©a exposure levels to indoor
users oS pesHeidas. AlQiouga Wolfe et &L
(1967) Sisted.only two SndooF-studies,
one of these Involved a case is." which
indoor house spraying results^ in dermal
andTespiratory exposure to the active
ingredient of- 1,755 and,7.1 mg/hr re-
spectively—some 2-3 times larger than
the- highst 2gur«s listed to- the Wolfe
studies^'ES resulting from, outdoor use,:
suggesttas thafc indoor usss may restslt
in higher rstes of exposure,-both to ap-
plicators and to others exposed to ths
^pesticides. However, the fact that pesti-
cides are usually sprayed indoors only
for short periods decreases the hazard.
Accordingly," it is unlikely that typical
indoor exposures would approach those
experienced by outdoor users working for
a full day. This finding- Is supported by.
•accident date^hich-'do. nofe indicate-" a."
substantial frequency of poisonings from.
indoor use other then, accidental inges-
tioas by children.13 "Sliere is Indirect evi-
dence'from residue monitoring that-in- .
door uses are responsible for a sub-
stantial portion .of the average person's
exposure- to • pesticides.0 - but such lorr
level exposure would lavolve subacute or
chronic fcoxie-eEecfe rather than acute-
poisoning. Chronic tosdcity hazards are"
addressed uader the criteria of 5.162.11
(e> (1) end (2), No criterion Is included
for dermal exposure to the use-diluted
product in domestic situations.
- uv> Respiratory exposures. The meas-
urements summarized by Wolfe et o£
suggest that ia most.cases dermal exr
posures greatly- exceed respiratory~ex-;
posures, often by a factor of 50 or more,*1
The largest reported, respiratory expo-
.sure was only 1.4 g/hr, to a spray'formu- .
lation, and even in this case it is not clear
that, a substantial, part-of, the material
was -in; droplets -small enough, to enter
tha-lungs. "Accordingly, It seems likely
thafe -respiratory 'exposure would be of
much. less 'signifleance-' to applicators
thass'dermal exposures. According to ac-
•ssident summaries; the principal, hazards
posed by respiratory exposures would be-
1 to ssaaU children and to asthusatlcs.1* •'•'•
• -(?> 'Acci&ente}, esposure to children.
When pesticides are used-ln domestics
situations, there Is "the possibility that
. the pesticides may be accessible to chil-
dren or pets. As discussed above,, poison- • •
ing- statistics indicate that the possibility
is frecently realized since approximate-
ly 80 percent of all poisonings involve
young children. Labeling is of no value in
preventing accidents If the child can gain
access, to the pesticide- product. Studies "
of domestic accidents reveal several ge'nr
era! characteristics of pesticide accidents .
aSecting. children. For children, under 2
years old, exposure is generally by Inges-
tion, particularly from bait pesticides,"
motte bans and rodenUcidea used ire in-.-
door treated, areas. For children aged 2-5
years. • oral exposure, particularly ..to'
F, If of -the 10 mg cctJve
dopooiWon. onl7 3 mg resulted Ii-oai czposuro
ts> ttio Xiao-diluted product, fritii Gio otliss?
S mg resulting from cspoaura ta tho TCS°
diluted formulattoo, then tho T7o?tscE TTCO
ezposad to 3 Qg=100 mg of- uao=cllluto£3
.03 .
product. Tho letter enamplo roflccto ttio in°
troduction of c, fCiCtcr o? 6wo to occouafc fo?
tho feet th&t tho oiecsured deposition ccc-ujs
to wos-kora. who In the oourso o? thel? normcj
~2>ctlvl«c3. oro oxjjO3E-d to botto diluted aad
wadllutcd producto. • ..' .
a Wolfav H. K-, 3. S5. Armstrang. D. C. Sfcalff.
ciifi S. W. Oosaep, fhe Use of Protective
CZoffiteg erafi Equipment for Prevention of
Ssposrvsfo to Pesticides, PROCEEDINGS OP
THE S7A-SZONA3U -OOWFEKENCS ON
CLOTHXNO ASJE> SAPET
FOK 3?23TXCH>E WOEKSRS, 163
(1972).
Wolfe, et el., ep. clt. (19S7, 1972).
, et eJ, op. clt. (1S72).
sureo rafer to cctlva lagredlent
, 006 to tho uso dilutioQ exposure
ia £ho preceding filacuaaloa.
.
Badomaki, J, D2lclrmon".' W. B. and CU- -.
zap," K-S.. Pesticide Concentrations In tfie
Li-aaf, Brain an& Adipose Tissue of Terminai-
Eospital Patients, 3 PD. COSMET. TOXICOL,
202-220 (1968). --' .^. ,' -..-
01 Howover, It must- bo noted tnafr & p«stl- ;
eido Is more rapidly end completely absorbed
through the respiratory routs them through
the* dermal route and therefore a small" ex-
posure may b& toxlcologtcaUy slgnlflcait.
Where Indoor spraying Is-continued over 'a
long period of time, exposure may be quite
oSgalficont. Poy esomplo, -Wolfe et al. h'STe
reported that: °[I]a tbo cesa of DDT . . .
Indoor houso spraying OTS about 4. tlmea as
h&sardous CG Sagging for airplane dusting
of fruig orchards, approKlme,tely 7 times as
hazardous as outdoor house spraying, end
over 30 times as hazardous as operating an air
blase'spray machine In & fruit orchard."
Woifo et al.. Exposure of Workers to Pestfc-".
Sides, supra 66 623. • _ • " -.".••>
oj^j^de, S. Aft, Spi&3H»totoffisoJ Study of
Pestiei&e~ Exposures to Allegheny County,
PennoytvcniE., 39 AHCE, SJ^reTBBOJf. HEALTH—
CO (1974). ' V .-.. ' .•:••-..:>{*'.
-
B26IST6B,
3.
-------
138
ANB REGULATIONS
pesticides. Is vwy significant, as is
eye and dermal exposure from all types
of formulations bat particularly from
dost or granule formulations.'* Exposure
for children aged 2-6 occurs in all areas
of pesticide use." both Indoors and out-
doer*.- - •• . • .. .••;-. ±L.~ ••-•••
It i» difficult to estimate the precise
'degree of exposure of small children to-
pesticides, but thsre is evidence from
documented incidents of fatal
-------
139 *
..-' doses -when plotted on logarithmic-prob-
. ability paper..The slope of the line varies
., "according to the -test organism and the
... nature of the toxicant. From a cross-sec-
tton of existing dose-response data.lt has
—been, estimated that a typical slope is 4.5
• gn-obits per -log cycle, and a minimum
. stop® about 2 problts per. log cycle. The
: latter situation corresponds to a very
• ^variable test population with some Indl-
Viduals displaying high sensitivity to the .
' toxicant. From this model it can be esti-
mated that a dose or_exposure 10 times
lower titars the IJDso or LCm would be ex-
pected to lead to a mortality rate, of
about 0.01 percent under typical slope
conditions, but .to-a mortality-rate of 4
percent under minimum, slope conditions.
A dose-response 5 times lower than the
LD» or. LCd would be expected to lead •
to mortality rates of aboufJU percent
and 10 percent respectively. These figures
are used as the basis for selecting a, safety
factor of S-10 for setting the classifica-
tion criteria for protecting wildlife. These
factors would be expected to provide an
ample margin of safety for a typical
species, but only marginal protection to
.the-most variable species. Even larger
. safety factors than 10 would be desirable..
to ensure protection of species in which.
~ even & single death is of special concern,",
for instance the death o£ an endangered -
species. '••'•• ' '
(iv) A /actor to allow 'differences on
sensitivity between test attimals and man.
• A safety factor of 10 is commonly applied
to extrapolate from test animals to man
on the basis that the variability of hu-
man sensitivity is greater than the vari-
ability of test animal sensitivity. Where
precise data are. available on toxicity to
humans—from accident records on pres-
ently registered products—the use. of
smaller factors may be justified.
d. Selection of over all safety factors to
prevent unreasonable adverse effects.
-Each of the safety factors discussed
above is individually desirable to protect
against .hazards posed by extreme and
unusual exposure. However, if efl the
safety factors are applied independently,
the process might simply serve- to pro-
tect against extremes of extremes. It is .
Impossible to devise criteria that could
eliminate all hazards for pesticide use,
and the statutory standard does not con-
template such stringent criteria. The
criteria sleeted must provide aginst un-
reasonable-adverse effects, not all ad-
verse effects. Therefore, it is necessary to
- select safety criteria that will reduce the
'probability of injury to an acceptable
level, considering the number of individ-
ual persons and the populations of im-
portant wildlife at significant risk, the
probable frequency of sensitive indivld-
•oals within the populations, and She
probability of above-average exposure.
Accordingly, safety factors between 3 and
10 have been used to provide protection
against unreasonable adverse effects for
the principal types of hazards discussed
above. The precise safety factors used in-
setting numerical criteria, and the ra=
SonalQ for selecting them, are set fort&
8n the next sections.
.- 3. Numerical Criteria for Use Classifi-
cation, a. General numerical criteria for
use classification. The Administrator has
determined that pesticide formulations
which tel' into Tosdcity Categories m
and IV will.hbt generally cause unreason-
able hazards if handled and used by un-
trained persons. In addition, pesticide
formulations which fall into Toxicity
Category n will generally not cause un-
reasonable adverse effects if used by the
normally more skillfu' applicators who
apply pesticides in nondomestlc situa-
tions. However, for the reasons given
above, the Administrator has determined
that additional numerical criteria besides
the tozicity categories of the>formulated
pesticide are needed t*f protect against
certain adverse effects. ;•- .
b. Additional numerical criteria for
useclr°rificatir-». ".) Acute oral toxicity.
As shown atu>e, cnildrex* may be- ex-
pected to lugesu, under-certain c. ndi-
tions, pesticide, stored or used in do-
mestic situations at doses up to 0.5 g/kg.
.This is predicated on the assumption that
the child gains access to., the pesticide
chemical mixture. If, however, the pesH-
cide-formulation is specially packaged ia>
s. container that is "child-resistant"' in
the sense that- childrenunder 5 y^ars
cannot normally gain:access in a rea-
sonable amount of. time, the possibility of
exposure is minimized; Accordingly, no
criterion is given for acute oral LDs> on
the formulated product. The Agency will
be publishing regulations shortly, pursu=
•ant to the authority ol section 25 (c) (3>
of- the Act, concerning1 standards for
packaging of the 'formulated pesticide
product. '"•."' -~ . • :' —
- A criterion Is provided in these regula-
tions, however,, to protect the child, from
ingestion of the product in domestic ap-
plication sites after it has been diluted
for use; Normally, the container in which
a pesticide is held when diluted for use is
accessible to children. A safety factor of
3 is applied Jx> the 0.5 g/kg exposure
figure. The resulting criterion is an acute
oral LDo of 1.5 g/kg on the product as
diluted for use. The products that have
an acute oral use dilution LBa below-
this- figure "will bs candidates for re-
stricted use classification." A relatively
few safety factor of 3 is justified because
accident .data can be used to supplement
toxicity. criteria ia Identifying product
°Becaus3 16 la difficult fco measure the
toxicity of materials sfc very high doses, tho
Guidelines es currently proposed specify fchafi
Numerical tozlclty measures ere not required
if tha orci or dermal LDM exceed 5 g/fcg. Ffe?
the purpose of determining whether a prod-
uct meats the numeric^ criteria derived la
this traction, is will be permissible to
estimate the LDM of & pesticide- product from
measurements of toslctty made of higher
concentrations. For example, the LDM of a
product as diluted for use may be estimated
OB -XT, where X IB the XJDM of tho formulated
product nod 7 is the factor by which the
formulation is diluted for use. In cases where
tho LDg, of the formulated produce exceeds
8 g/fcg. Its tojdclty may be estimated In tho
cos-responding way from too LDa of the active
Sagredleafe,.
uses that should be classified for re-
stricted use. --.""• . -.-•-:
Ui) Acute dermal toxicity. As shown
above, applicators and others may be ex-
posed to doses of the use-diluted pesticide
in spray or mist formulations as high,
as 16 g/kg/day, -when the pesticides are
applied by unskilled or careless applica-
tors. Since the exposure an unskilled
applicator may experience Is known from
the field studies conducted by Wolfe
et al., & precise LDs, criterion can be
selected to adequately protect applicators
receiving such exposure levels. Apply-.
ing the minimum safety factor of 3 to an
acute dermal LDjo of 16vg/kg/day would-
- result in an- LD value of 48 g/kg/day.
However, LDc, values and LD values are
based on experimental a^m-iai exposure
of 24 hours. Since applicators normally
are only exposed up to a maximum of 8
hours, using experimental data based
on a continuous 24 hour exposure em-
ploys a safety factor to protect humans
who are only exposed for' Yz the time.
Moreover, Durham, et oZ.,-has shown
that bathing afte^exposure results in a-
rapid decrease in dermal absorption • of
-pesticides. Therefore;. - since the • parr:
cent of pesticide dermally absorbed-is,
partially a function, of ..time the actual-
absorption .of. the -' pesticide- may be .
-much less than the indicated dermal
exposure if the applicator washes after
application.0- Accordingly, an acute
dermal LD» criterion of 18 g/kg/day has
been selected; it takes into account an
approximate safety factor of three. ''
A safety factor of 3 is justified by the
following considerations: (a) the safety
,factor is applied to file high range- of
exposure values measured in actual 2aid
studies; (b) accident data can be utilized '
to supplement numerical criteria to
.identify pesticides whose use. should be
restricted. However, a safety factor looser
than 3 would not be appropriate since
measurements of actual exposure in the •
field Indicate that toxic doses may be ap-
proached under conditions of widespread
and commonly recognized practice of
use.' . . , • .-•• • ..* • . - :.-[
For reasons stated above,.this criterion
is applied only to pesticides used la non-
domestic situations. Although domestic
indoor applications at times may invcive-
totenss exposures, this fact Is more than,
offset by tie short periods of indoor ex- .
posure normally experienced by non-pro-
fessional applicators. The dermal and in-- .-
halation toxicity criteria of the Toxicity
Categorization Scheme are sufficient to.
protect unskilled persons exposed indoors
against acute effects of pesticides in
Categories EC or IV.
(ill) Hazards to terrestrial wildlife.
The principal hazard to terrestrial wild-
life occurs from contamination of their
food with pesticides. To afford a measure
of protection for mammalian species,
pesticides intended for outdoor use which
result in residues exceeding one-fifth of
Q Durham. E. P. Wolfe, HB^ ond Elliot,
3. W. Absorption and. ZseretioK of Parathtan.
&5 Sjn-eymen. 24 ARCH. EOTTROW. HEALTH,
SSI (1S72). . -. , ...... _ ---.-.
BieiSTEB, VOL 46, W©. ?29-=?HUKSSAV/JU!,Y 3, WS-
-------
RUtiS ANO REGULATIONS
the acute oral LD* witt be candidates for
restricted use. The Agency realizes that
certain situations exist in which Vie sub-
acute dietary LC» may be a more appro-
priate standard ™*^ mommnHaji toxicity.
However, given the difficulties in obtain-
ing such, data for meaningful: mam-
malian indicator species the criterion em-
ploys the more readily obtainable acute
oral LD» Acceptable protocols for ob-
taining subacute dietary LCu data are
available, however, to represent toxicity ™
to avtan species. Accordingly, pesticides
intended for outdoor use which, result in
residues exceeding one-fifth of the sub-
acute dietary Ld, will' also be candidates
for restricted use. The criteria also spec-
ify that the residues axe to be computed .
'immediately after application, the time
' of maximum residues. Since these resi-
dues may degrade over -time, an addi-
tional safety factor is thereby incorpo-
rated. • . •':.'.. ;' -. .•..„ ---
The choice of a slightly higher safety
factor for aquatic, wildlife than for ter-
restrial wildlife Is based on the fact that
birds aiid mammals, unlike aquatic wild-
life, have the ability to at least partially
limit their exposure to pesticides by mov-
_ iz^r out of treated areas or by switching
to alternative fpods; moreover, some ani-
mals-cease feeding when they start to ex- ~
L^erience toxic symptoms.
'.ivy Hazards 'to aquatic organisms.
'-...-> principle hazard £o aquatic orga-
- "jlsras occurs when pesticides are applied
;,irectly to shaJovr water, especially when.'
~?:?lie«S by unskilled persons in contra-
• i£ic;:. ai; 2ciei directions for "use and
-.-.^xiuttLOZiazy sSateznen'is. A measure of*
as likely expos-are is the average ccacen-
^•atton of 'the :;33^cide when applied to a
^ater body 6 iaelias deep. A saf eiy factor,
•& 5_w«iuld F^yf--*3 an adequate Margin
~. Is A the mc4rt saadtlve
. -:'.caal. factor "of 2 la'ap-
., terrestrial WilcJfs, ac- .
-•- nave no meara of es-
a",
xrater
.. species
' tea for
cpato
aiders,
Bussed
tng tfc
e: — ^si
tfe- ;• r:
for ^3b
:r& Aff&inst Rsyistrat&f:, y? Re-
Besides - •'.••.-.23 a.- .. tox-
• . /:, for • mrl.-JI' isfc, _/-a
•". fcavs'alsc '
-.::.:: ^ •>.
_•- -ste.rec! c?
yate tox-
rfvsd for'
rdal or
- c.on-
a*.
is: rtv-
,. i of
ay Acute Orel ToxlcUy. No acute oral
toziclty criterion is included for deter-*
mining a rebuttable presumption against
registration. Such a. criterion,was- in-
c. :dad in the propped regulation
[$ 182.1Kb) (2) (1) (D) ] and was the sub-
ject ot a number of comments. The
Agdner has concludcc* that trained, com-
petent Applicators will be able to mini-
mize the hazards to children by adhering
to general safety procedures and specific
label directions for use. If based upon the
use and accident history data of the
product, or similar products, the Admin-
istrator determines that even when used
by trained applicators the pesticide
causes or -will cause unreasonable ad»
verse effects on man or the environment,
the pesticide will be denied registration
or cancelled In accordance with S 162.11-
(a) (6) of these regulations..
;/- <2> Dermal Toxicity Criteria. All pes-
ticides In Toxicity Category I will be
candidates for restricted use classlflca- .
tion and unless it is shown that the risk
from- use of the pesticide is not as great
as indicated by this criteria for risk, use
of the-pesticide wilLbe restricted to cer-
tified applicators. Yet as the literature
cited above indicates, even skilled appli-
cators may receive potentially lethal ex-
posure to the highly concentrated and
toxic formulated pesticide and to. the
use-diluted pesticide. Accordingly, acute
dermal toxicity criteria for both the for-
mulated and use-diluted pesticide are in-
cluded to determine if there is-;a rebutta-
ble presumption against initial or con-
tinued registration. For the formulated
product, a criterion of an acute dermal
LCa. of 40 mg/kg 'or less has been
selected. Products, meeting this criterion
have ah LD» that is %th that of the LD»
ol {&& non-domestic use pesticides, tnd
i/jjuii tCTo±.' of tha f-i\s of • the domestic
use pesticide initially classified for re-
stricted use because of dermal toxicity.
* Clearly, the K££3ln of safe exposure for
sucls-pesttci:fi£, ii- extremely amaii uid
sxich pesticides Erost receive particular
scrutiny before the Administrator can
determine that the pesticide will not gen-
erally cause unreasonable adverse ef-
J»a- acute dermal LC0 of' 6/g/kg sri-
teiion for tha use-dHutica of pesticides
tors; ^^te-" as :i i^i^i yi asacay, has been
s€J£-'^sci cc .-^vs i;vss '^ & ^eSyuttafcle ^irg—
si L- riioffi. n '"Vi. registratior. iLsed
u; ••:.. :•>.:, resciu..«-' the Wolfs, m .(^, ex-
aSscusseoi above wiiici ln-^
.'.iitiolpated it
^cators. These;
> skilled applicator can ez^pe-
.i" o g/kg/d£,y 0* exposurt) to
product. For the same
pi. ^TO ^'
d__-. •.. i '
tc s-- ^3
tb?;. —
n ...-• -
t£. -ise
1" toxis 52si- lii
.^.4ctea'vS2i;-.^
^sjs by skilled,
,ua»s alga.
Oife apcde
m7! fes csr.Tto'Cc. "-.
It
ol Traaa-
also
i'^o tei -^i
iy toxis^ material. 1'ae
res&lcted ua>
K.
ioentlce^ '
iiii with oa acute
^- leaa, which eiosely .^
'ft criterto o2 4S aa^/'ig.
&aa eotabUslied » iil-
'•' ^ Agencyj to indicate
~
reasons discussed above in the explana-
tion of the dermal classification crite-
rion, this criterion incorporates a safety
factor of 3.
(3) Inhalation Toxicity Criterion. An
inhalation toxicity criterion of an LCa>
of £40 mg/1 or less has been selected
to give rise to a rebuttable presumption
against registration. Pesticides meeting
this criterion have an LCn that is ysth
the LCw of the non-domestic use pesti-
cides which are candidates for restricted
use because of inhalation toxicity.
(4) Wildlife Toxicity Criteria. Based
upon the considerations discussed in the
determination of classification criteria,
the following; criteria have been selected
to safeguard wildlife by giving rise to a
rebuttable presumption against registra-
tion: _ -••_ . .. . -. .
If a peafBfclde's Ingredient (a), metabo-
lite (s), or degradation pioduct(s):
(1) Occurra* a residue Immediately fol-
lowing application In or on the feed of. a
TTv«jnTT>aii»T» species representative of .the
species likely to be exposed to such feed In
amounts equivalent to the average dally In-
take of such representative species, at levels
equal to or greater than the acute oral
T.r>^ measured in Tnn.Tr
-------
141
.'..'-' -i; Sereeninig Criteria, for Classification* •
'•• Jrne chronie effects criteria which indi-
.'- cats es aaSnlttel matter that the pesti-
cide will bs classified for restricted use
• ayg qualitative te, nature. Chronic toJdc-
Ity.effects caanot easily be evaluated on
6 comparative quantitative seals, as can.
£&Q ecuts-toslcSty LDo and I/Co values.
, Chronic effects .by definition are. those
caused by-repeated and prolonged -ex-
posure. The- chronic- hazard of & pesti-
cide is, moreover, & function of its chemi-
cal and environmental, characteristics
• such as porsiatence, mobility, sad poten-
tial for biomagniflcatioa in food chains,
end bioaccmnulation ia htsman tissue.
Humana and other organisms wUS gen,=
erally be exposed to pesticides which are
highly persistent, mobile and-biooccumu-
IsQm Tho major issue regarding pestX- -
cides with these properties is whether the
. pesticide should ba registered. Classiflca-
t£on of & pesticide use1 as restricted In all
likelihood will not reduce the threat of
exposure to large populations. Accord-
ingly, whfla § 162.11 te) authorizes the
classification decision to ba based on as
evaluation of .chronic tosdclty effects,
J-such, -pesticides will bs- classified-as-re=
'"-BtElcted use- only where restetetioB of use •
- . to. a certified applicator cooXd-. be- antici-
'•-' pated- to-- limifc the exposure-- or-Lwher& s"
•regulation could b& promulgated pur- "
suant to § lS2-li(e> (3) -with restrictions .
to control the-exposure. i_ " "."•"-
2; Screening Criterie for Sebuttable
Presumption. Section 162.11 (a) (3) (ii)
sets forth three basic risk criteria for the
determination of-chronic effecte which
if met or exceeded by "a pesticide's in-
gredient (s>, metabolite(s-), or degrada-
tion, product (s)," give rise to a rebutta-'
ble presumption, against registration os
continued registration. Section 162.11 (a)
(3) (II) (A) provides that such s pre-
sumption shan. arise for any pesticide
Which Induces "oncogenie effects hi ex-
perimental mammalian species or in man
as a result of oral, inhalation, or. dermal
resposure; or Induces mutagen'.e- effects...
as determined by multitest evidence."
With respect, to oncogenie effects,, this
criterion, incorporates • the policy and
principles established in the DDT 'can-.
cellation proceeding and' the' Aldrin/
Dieldrin suspension proceeding. -
.-•Positive oncogenlc. effects in man
would obviously trigger very serious
scrutiny. However, as noted above, such,
results are rarely available'because of
the long latency period of tumor induc-
tion, because of frequently encountered
widespread contamination which makes
it impossible to establish an racon=
laminated control group and because of
the ethical and legal problems associated
with conducting cancer research on hu-
mans."3 Because of the difficulties of ob=
•taining reliable immaa cancer data, the
oncogenie criterion refers to positive-on-
cogenlc effects la ™*vi or "in experi-
mental mammalian species." °Hie use of
«inimftH test data to evaluate hum&Ji
can<*er risks has been widely accepted
by the scientific community and by pub-
lic - policy-making agencies. Moreover,
'such data are particularly- appropriate
because the relatively short life span of
test o-CTtewJ.? allows for tes&ng for the.
entire latency period »ad because of our
relatively well-developed understanding
of the pathological development of tu-
mors is mice and rats. When compared
to the millions of. people who. may. be
exposed to the pesticide, the number of.
«iTitm«iiin used in. .oncogenie tests is ex-
tremely small, As in the case of acuts
toxici&y .testing, the variability of Jiu--
man response to carcinogens Is generally
greater tha_ that; of tts test animals.
Accordingly, a* noted" above, a-jrisitive-
.oncogenie effi '. in any test animal Is
sufficient te- characterize the pesticide
ss posing- a, cancer risk to. man. By the
same; reasoning, negative results from.
oncogenie animal tests have only limited
significance and thus should normally -
fes- superseded by positive, results. The
; number and sensittvity-'df toe test aal- .
msls ss compared to the general human
population are the principal -reasons for
. this limited utility.^ .'".•• ^. ....'. ' ...-
The Administrator in- his AldrJa/
Dieldrin suspension, order also specifically
concluded that because of these inherent
limitations of animal testing "a sub-
stance that will induce cancer in expert- •
mental animals at any dose level, no
: matter howlxigh. or low, should be treated
with great caution." M The Court of Ap-
peals unanimously affirmed this finding.
As noted above, negative results &re of
'limited- value and although & nc-effec&
level may theoretically exist, ife is fre-
quently impossible to establish, with suffl-
cieni confidence to Justify sanctioning
.widespread human exposure,^ -. . • •
» Sea Consolidated- DOT Hearings, Opinion
and Order of the Administrator 37 PR 13369,
13371; Shell Chemical Company, et at,. Find-
Lags of Fact and Conclusions (PIFRA Dockets
No. 145 etc.). 38 FR 37349. 37233, 37234;
Opinion and Order of the Administrator on
Suspension of Aldrln-Dleldrln. 39 FR 37263.
37270; EOF V. EPA 510 P. 2d at 1299; Supple-
mental Statement of Reasons for Denial—
Steto of Louisiana Request for Emergency
Uso of DDT OB Cotton, 00 FR 13949, 1S950.
generally; Consolldetsfi'DDTP Hear-
ings; Opinion and Order o£'t£iQ Admlnlstrf^
tor; 37 PR afc 13371; Shell Chemical Company.
•03 aL Findings o£ Pac-6 end, Conclualon^ 39
FR c&. 37352, 37294; Shell Chemical Com-
pany, at ei. Oplnioa. of. the Admlnlstrstor,
89 FR Es6 3728&-70; EOF V. SPA, S10 F. 2d a6
1299; Statement of Reasons end' Supple-
mental Statement o£ Reasons for Danl&l—
Stoto of 'Louisiana Request for Emergency
T7SQ'of DDT on Cotton, Administrator Aldrin/Dieldrin Findings,
39 FR c& 37268: • •
07 This Vlevr t?as mirrored In the-recently
published- "Report' of the Committed for
Wording:Conference} on Principles of Proto-
cols for Evaluating Chemicals In the Environ-
ment." "[The term no-eCece level] Is statis-
tically meaningless end therefore of limited
value since It merely metma th&t no- effect
-•CTCS observed In studies using c, group of.
animals of particular size. Such on observa-
tion Is completely compatible with the pres-
ence of an adverse effect, which In further
'studies with l&rger sample sizes or with dif-
ferent types of observation might lead to a
positive outcome." Environmental Studies
Board National Academy of Engineering and
Committee on Toxicology. National Research
Council. Principles for Evaluating Chemicals
in the ETMrintmment, (1973).
•Moreover as an."additional outgrowth.
of the Aldrin/Dieldrta proceedings- and
as explained previously in the discussion
of §162J(bb), the term "oncoffenic" is
used in the regnlatloas because the Ad-
ministrator had determined that the dis-
tinction between "benign" and "malig-
nant" tumors is not meaningful . in
determining the hazard of cancer to man
on the.basis of tests conducted on. a
laboratory species, given the "incrsasizs
evidence that many tumors can dSTeiep-
into" cancers."-He has determined that
."for purposes of carcinogenlcity testing;
they should be considered synonymous.""
—_• in making the determination that the
rebuttable presumption is activated be-
cause of & finding, of chronic effects, the
Agency will take Into consideration the
type of effect, the-statistical significance
of the findings and whether the tests
ware conducted in. accordance with the
' material requirements for valid tests as
recognized by experts- ia the field. Where
testing produces positive chronic effects
but such effects-are not statistically sig-
"nificant^or such tests were not conducted
in accordance with the material require-
ments, for .mild, tests- as recognized by
'expert-ia the £teld,'additional statistical
analysis,, titetological or other.pa,thologi-
"-csX Eeview, or testing may bs required
•eves though; the rebuttable presumption
.!may not have been-.triggered bytha
initiai test results. . -- - - -;—
While neither the DDT cancellation
proceeding'nor the Aldrin/Dieldrin sus-
pension, proceeding considered the haz-
ards to man. from exposure to mutagenic
substances, governmental agencies and
scientific groups .which are . currently
weighing the hazards of'introducing
potentially mutagenic substances into
the environment stress the inherent risk:
to man.0 Furthermore, on the basis, of
tests on microblal' systems,, there Is.In-
creasing, evidence indicating & correla-
tion between carcinogenesis and rrruta-
genesis.^ At this time without additional
"corroborative evidehcei however,, there
•is no single animal test protocol which
has been demonstrated as a sufficiently
reliable Indicator of,asubstance's rauia-'
genie hazard to man to give rise-to a.-
jrebuttable presumption against registra-
tion, or continued registration. There-
fore, the mutagenic.criterion requires a
showing o£ positive results in more than
one test system before, regulatory action,
other than requiring additional testing,
. caa be justified. The Guidelines for reg-
istering pesticides set forth the condi-
tions under which, mutagenic testing; is
required and the Appendix.to the Guide-
lines sets forth acceptable test protocols.
It is not the policy of EPA to ban all
pesticides which produce oncogenie or
•ra Administrator's Aldrtn/Dleldrin Findings,
39 FR at 37287 (October 18. 1974); EOF v.
SPA, 510 F. 2d at 1300 (D.C. Clr. 1975).
D Principles for Etaliuiting chemicals in
the Environment, supra: The Testing of
Chemicals for Carcinoyenicity, Mutagenicity,
Teratogenicity, published by the Minister of
Health and Welfare, C^""*^ (September.
1973); and BnvinrnmerRtaX Mwtagenle Baz~-
eti*, 187SCIENCE603 (1973). . .
0 Principles, supra, at 147.. ... •
. FEBEBAt BE6ISTER, VOL. 40, NO. 129—THUBSBAY, JULY 3. 1975
-------
142
: KHJES AND REGULATIONS
mutagenic effects. Rather,, the cost of
control, the levels of exposure, and the
beneflU of use must also be taken In ac-.
count in any final regulatory decision.
This Bittern 152,11 establishes a frame-
work for arriving at these decisions with
a full opportunity for the public and
other Interested parties to participates
The second criterion, for chronic ef-
fects set forth in 1162Jl(a) (3)
(2) Uu> at the Act provides that any
pesticide .which is "highly toxic to man"
is miittmjvtfti ifnium the label beats "a
anticipated to be exposed, taking, into
account ample margins of. safety." The
dosage to be tested win. be. specified in
"the Registration Guidelines. In deter r
mining the levels at which positive test
results will give rise to a rebuttable pre-
sumption the Administrator must take
into account ample margins; of safety
and evaluate «mn«ng other things: the
statistical reliability of. the test data; the
degree of varying sensitivity estimated
for exposed populations, and the' nature
of the chronic effect: produced. Chem-
icals have been found . to produce
deleterious effects after prolonged and
repeated exposure to many organs and
functions of the body including
lungs, central nervous system, hema-
topoletic- system, metabolism, kidneys,
reproductive systems and others. There-
fore; If -adverse effects of such a -nature"
^wfll bexproduced by exposure. to a pestt-
' clde at any" level up to a level exceeding .
possible: human exposure taking into ac-
count ample margins of safety, it is ap-
propriate that the regulations provide a-
rebuttable presumption against registra-
. tion or continued registration of the pes-
ticide. The pesticide's potential for pro-
ducing such effects is determined from
studies required pursuant to g 142.8 of
these regulations, the- Guidelines., and*
the Appendix to the. Guidelines, or other
test evidence available to the Agency.. — .
• The proposed regulation also provided
that a presumption against registration
would arise if evidence* of teratogenic
* potential was found, irrespective of level
. of exposure in test animals. - However,
the- Agency has determined with respect
.to teratogenic effects, that the dose at~
which the effect was observed in expert- •
mar^^i nntmn.7.1 and the dose to which.
xbumans may be exposed must be consld-
' ered before- a rebuttable presumption
against registration arises. Therefore,
evaluation for teratogenic effect is In-
corporated in. the criterion at 1 162.11 (a)
The final criterion set forth in } 162.11
(a) (3) (11> (C) establishes a. criterion to
protect against significant reductions in-
local. regional, or national populations of
non- target organisms or fatality to mem-
bers of endangered species. In the DDT
cancellation decision, the Administrator
found that DDT can reasonably be an-
ticipated to result hi such chronic effects
on non-target organisms and included .
statement of a practical treatment (first
aid or otherwise) in case of poisoning by
the pesticide."* Accordingly, where
there is no practical treatment in the case
of po (3) (ill) has been modified to
clarify that an emergency treatment.
statement is only required for treatment
of>~ acute poisonings from a--' single
exposure. •" ',.*-•--
F. Rebuttal of- Screening Criteria for
Use Classification and-. •• Presumption
Against Registration. As is discussed
above, the. criteria set forth in {{ 162.11
.(a) (3). and 182O1CO (I) and (2) are
intended as screening ™»«»naT the. need for "specialized ap-
paratus, protective equipment or mate-
rial" normally not available to the gen-
eral public; and (5) the effect of: failure
to follow directions for use ux causing
.delayed or chronic adverse effects. Fur-
thermore, the use- and accident history
of a pesticide or a similar pesticide will
bear on the evaluation and application
of these criteria to the classification de- -
dsion of a, particular pesticide. These
criteria were contained in the proposed
-regulations and have not been mnriiflad
They were- selected as representing the
-factors that would determine the degree
that an mmiriiTart appllcator"could be ex-
pected to follow label directions for use
and required safety procedures. They re-
quire a weighing of the complexity of use
of a pesticide to accordance with label-
instructions, the likelihood ttmt instruc-
tions commonly will be followed, and the
adverse effects likely to-result If the label
instructions are not followed. Secondly,
the applicant or registrant may submit
data or arguments nrmiiftngipg ^H*. find-
ing of the Agency that.the criteria have
been- met or may be able to establish
that the formulation, packaging or
method of use of the product is such as
•to eliminate the hazardous route of ex-
posure. For example, a pesticide which
meets the criteria for restricted use clas-
sification on the basis of dermal risk may
be marketed as a granular formulation
rather than as a liquid formulation and
thereby 'reduce the hazards of dermal"
exposure; So too, if the formulation of
- the pesticide is extremely toxic while Its
use dilution is not, the pesticide may be
packaged as a "dosed system" to prevent
hazardous exposure during mi-ring And
fourthly, the applicant or registrant may
demonstrate that the benefits from un-
restricted use of the pesticide outweigh
the risks of unrestricted use of the pesti-
cide. All these determinations are in ac-
cordance with the statutory mandate of
section 3(d> of the Act, that the Admin-
istrator determine whether general use
classification of the pesticide will cause
"unreasonable adverse effects on the en-
vironment." • • •
In addition to the screening criteria,
} 162.11(c) (4) provides that "if the
.Agency determines.that based on human
toxicologies! data, use history, accident
data, monitoring data, or such other evi-
dence as the Administrator Identifies,
.the product use(s) may pose a serious--
hazard to man or the environment,
which can be prevented by classification
• for restricted use," the use will be classi-
fied restricted. Thus, although based on
the screening criteria a pesticide would •
be a candidate for general use classifies-.
- tion. it could be classified for restricted
•A registered pesticide which la mis-
branded la in violation of section 8(b)' and
must b» canc*nou. f -i application lot » new
reglatratlon/must bo denied pursuant to sec-
tion 3(o) (6) and (6) If "tts labeling and
other material required/to be submitted [do
not] comply with the requirements of this
. _. *• 5 .
Act."
\
"This language has,been Interpreted by
the Eighth Circuit Court of Appeals to mean
the uses and practices commonly followed
which are not approved on the label and la-
beling. Southern National Manufacturing
Co. tile. T. Xnvtronmental Protection Agency,
470 P. 2d 194 (1972). .
FEDERAL REGISTER, VOL 40,. NO. 129—THURSDAY, JULY 3. 1975
-------
-143
TISS on ihe basis ..of other evidence
able-ta the AdministratoE. • ..
'- Ksa3l5r,.cs part of the classifl
, Iia2,U(c)(5) provides.
.
fc. osy product use classified fop re-
etsfi'csa sad limited to application
v by or under tha direct supervision of a
applicata? may "additionally a?
".h2.ve other restrictions im-
lsaos. A commeater argued.
"otlses- resteictions" authorised
T..-&5-s£stta 3(dXiHC) (u) o£the Aet.and
- -'prOTided fos by this Section of the-.reg-
Tgfetioas can be imposed only in liea. of,.
aofe to addi&an to, as certified applicator
: restsicticsn. However, such, an interprefca-
- fe&offi: coafiicts- with tixe legislative his-
tory o£ this provision. "Section 3(d) (4)
, :(O(SU establishes a system to. assure
y c, £aH .sad fair consideration of alterne-
• £Jve or additional restrictions which the
--Administrato? may wish to impose." Sen-
••"•'• ata-Agriculture Committee Report; at 21.
v-The restrictions cited in the regulation
"•.are intended merely as examples of. the
. -fcypa- of restrictions which may be 1m-
- 'posed under this authority.
:.--:sbovi£;-.& rebuttable.. presumption arises;
jUagalast registration or eontmued..regis-
'"•/ teaSoa of any pesticide which, meets
-------
AW
' E.
en to the balaneQ oS
- stetsi ead fesaefiteL Bssed os a rseom-
benefits appear to- 006= •
sisls, toe Admtaistrstor may-
•'deeida to teraa & section 6) (3) notice
. cad fe&essby taifiste a, forzaaS adjudica^..
tory feca&sg where Sxs beaeSt/risfe.bal.-.
lie fasom for purposes of msfeSas s flael
ES te esaeellaSEB,
the resiseraafc to submit evidence
aaSte E£ too asms time a^he ua=
to' rebut the -presumption,
. witis respect -to. denials of
of e aotJce of deaial pursussafe
to sos^oa 3(e)-(6) , upon the. determine,-
the applicant has felled to re-=
the presumptioa as to risk. Ths
eorosspoad to the heastoff
S(b) (1) . Based on a preliminary
' sfecommendfition fcha^'beneats ap=
.to outweigh riskff, the Adiaiaistra-
tor may decide, es provided la the reg?
ulBfAoas to issue a notice of intent to hold
& fonaal adjudicator? hearing similar to
e section 8(b) (2) proceeding. The au-
SSiorl^y for toe regulations to provide for
axisrebrrespondlag sectioa 6(b) (2) pro* .
eeeding for denials of registrations rests
-cm Sis general authority of sections 25
(s>'«. 21 ead 6 of the Act. _. .. ' .-•:->
.-liio^foregolas procedures preserve toe
requSremente established by courts and
toe'Ac&thafe weighing of risks aad~bsne°
flSs^iay not' interfere with initiation of
' the forma! administrative process/where
& substsatiaJ Question; of safety exists,
- and yet provides the flexibility necessary.
fas informed, fair and- open Agency de~
' ' v '" '
or taat it would not
otherwise serve toe public .weltea. - As &
'genssaS rule SPA plaas to withdraw toe
aoties K thi
us® of toe
end if thsrQ- is no party . waling, to par-
ticipate to the'heaxtos who wffl ssgu©
.a ssctloa ®fb) (1) 'hesriag. In order
stssS' Feeoza=
will foJIowithis
misussr scarce
rule- so' ES aofc to
resources osr sufe=>
unnecessary'- es=
agres ' that: .4he '.pesticide should bs
registered. ... .-. .•- . :\"-r -•"
• With respect to:~toe fins! risk/benefit'
/detsraainatlcs uade? say of the'forego=
statute, Qie-
reeogalze thsi.£~ toe Admlaistrator may
fiad. ffiafe .the feaaeats-oS uss outweigh
toe risks even "where tois risfe Is detsr-
mSied to posa' & substantial question of
safety. Moreover, ;ls sfelMag toe balance,
certata risks aad certain benefits mu^t bsr
given more; weight thass others. As the
courfe statsd Ja BDF v...
. process to c, dsllcsto ono to
greats? TTeigtit aHooie b& cccorded t&e vduo
o2 e, pesticide' for tbo control of dieacso, cad
less wolgist sJiould bo Eccofdse lta_TOiuo tor
tho psotsctlon o£ & commercl&I' crop.. 438 F.
'' "
Section 132.14 Farms of plant and
Animci Life and -Viruses declared to
•pests. Section 25 , and S(b) (1), toe bur-
den of proof es to all issues rests square-
ly with toe applicant or registrant, as toe
case may be. K toe. hearing Is a section.
S(b) (2) proceeding or toe equivalent for
desolate of1 registration, ' toe burden . of
proof as to risks rests, with toe appllcaag
or registrant. The- Agency will put Into
evidence toe preliminary stafi recom~
mendations as to benefits, aqd ali- other
evidence from toe parties to toe proceed-
ing will be considered in 'arriving at e,
final determination as to whether bene-
fits esceed risks. •• - ••••"'.
The regulation provides for toe 'with-
drawal of toe notice of Intent to hold &
hearing' -prior to toe commencement of
toe hearing if toe Administrator deter-
mines that there is "InsuSclent public
to toe proceediag to warrant
Sectioa 162.13 Bevtcea. Subject to the.:
Act. Section 25 (c) (4)"of toe Act author-
izes the Administrator to specify those-
devices which- are subject to toe provi-
sions of paragraph 2(q) (1) or section 7
of the Act. The- proposed regulations at
§• 182.3 (ff) (1) and (4) had declared cer- ,
tain, devices subject to toe Act For pur-
poses of clarity and thoroughness, anew
§ 132.15 has been added to. these regula-
tions to specify in detail those'devices
which faU_wltoin toe purview . of
amended FIPBA..The Agency realizes
that certain instruments and contriv-
ances are marketed in conjunction with
s pesticide; in these cases.such products
will, be considered as pesticides rather-
than as devices. Devices deemed to be
subject to the .Act Include, but. are not
limited, to, instruments for toe purpose
of trapping, destroying, repelling' or
otherwise mitigatl?1? any form of plant
or animal life and Viruses declared to be'
pests at §132.14, except those instru-
ments' which the Administrator 7 deter-
mines either (1) to be adequately regu°
latsS by another Federal Agency, or (2)
to be of s& character which is unnecessary
to be subject to this Act la order to carry
out toe purposes of thisAct. ' •
Instruments of a character unneces-
sary to be subject to this Act Include (1)
fehos's which depead for their eSeetive-
ness more upoa the performance of toe
person using toe device thaa .oa toe per- •
foraaace of the device Itself, aad (2)
tocss which operate to eatrsp vertebrate
animals. Products generally failing with-
to thesa two- categories include refc."and
mouse traps, fly swatters, tillage; equip- .
meat for weed control aad fish traps; -
Eastrumeats -declared to be devices
subject to a 2(ci> (1) and section 7 of this
Act include but are not limited to: (A)
certain ultraviolet light systems, .ozone-.
generators, water alters and. air filters
(except those containing substances or "
,mtetures-of substances which are pestl- •
cides). aad ultrasonic devices, for which
claims, are made- to kill, inactivate, ea-
trap,-'or suppress toe growth of fungi,
bacteria, or viruses in-various sites; (B)
certain high frequency sound generators,
.carbide cannons, foils, aad rotating de-
vices, for which claims are made to repel
blrdsr (C) black light traps, .flytraps,
electronic-and best screens, fly ribbons,
aad~~8y- paper, for which claims are made
to kill or entrap certain insects; and (D)
mole thumpers, sound repellents, foils,
and -rotating devices, for which claims
are made to repel certain mammals. The
Administrator will designate such pro-
visions of paragraph 2(q) (1) and sec-
tion-7 of the Act toJbe applicable~fc> de-
vices as he finds necessary to effectuate
the purposes M toe Act. - '
"• Section 162.17 Cg 162.163 Registra-
tion Requirement for Intrastate Prod-
ucts. This section of the regulations has
" been rewritten to clarify toe language"
and incorporate much of toe'enforce-
ment policy that appeared in toe pream-
ble of toe regulations as~proposed. The
applicant for .registration must comply'
with toe data requirements for new reg-"
• istratioa provided however that the re-
• qulrement for. efficacy; • data may ' be
waived on the basis of the recommenda-
tion of a State agricultural, experimen-
tal Station or other Federal or State
agency' authorized by law to- conduct
•pesticide research. In addition, toe Ad-
^ministrator may initiate the waiver of
-otoer data requirements,-in accordance
with the standard of § 132.8(s) (3), in.
hlff-notlce to toe applicant to submit a
.'full application for federal registration.
'To ease toe transition from State to:
Federal registration, these applications
will be handled in a group of like prod-
-ucts rather than as individual products.
If toe applicant complies with toe pro-
- cedures of this section, pending the final
registration decision, either approving
or denying, toe registration application,
he may continue to sell or distribute the
product solely within intrastate com-
merce subject to the requirements of
paragraph (f) of this sec£ion.,This pol-
icy is in accordance with section 3(c) (2)
: of toe Act. .. -.'•"•
Section 182.21 [§ 162.15] Rules con-
cerniiiff certain pesticides. This section
is intended as an open-ended section to
include regulations' toe Agency promul-
DBSISTDK,
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;V-'i4S
'gates 1m th© future affecting reglstrstioE
.--or clffissJflcaHo-a 'of specific pesticides, ln-
• -Deluding' assy -other regulatory resfaric-
'i ttosjs imposed' pursuant to section 3(d>
•^-~«l> [SectSosx 132.21 (a>]
^•phosphorous. paste products. This sec-
/eZon. ss proposed,, provided thsfe pesti-
?c5de- products containing phosphorous
/pasts would.' bs> denied registration for
"i-aso- ja.;. oav dr around thg. home.' The
Assc-Koffi has besm deleted tfrora these final'
•Regulations. Pesticide products confcain-
•- Jag phcsphoroiB paste wfll be reviewed
la. accordance with all the provisions of
these regulations.
? :(2J Section 182.21(a> [gl62.150s>3
* Reqvxrementiof separate reffistre.tion:
• (a) Several cbmmenters asked thafe £hs
''provision afe g 162.21 (a) (1) regarding
^'separate registrations for certain fer--
.; tJSlzor-peaticlde-combinatians b® eistend-
i'ed alternatively either to include aJS
' registration, requirements or to encocx-
•pess all fertilizer-pesticide • combina-
- Sons. Neither of these suggestions Is
1 acceptable,- Whether separate registra-
tion of a fertilizer-pesticide combination
' is necessary to carrjuiut the purposes of
Lt&e Act must be deterzsiaed'ois & case
&3T ease basis. Wlthia the dises'££ica
' c£ the Administrator,, i£ the percentage
r of fertilizer components vary and the
application rate of the pesticide remains
.constant, the fertilizer-pesticide com-
binations may be registered as a single
" product, provided that the range pro-
Erased would aot require modification In
the labeling. The intent of this Section is
to lessen the administrative burden on
the Agency and the registrant, where
"of policy has as yet been polished in the
S-'EDEaaE, REGXSSES. The Agency Seels that
these regulations are a more appropriate
place of delineating tha permissible
.
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