GUIDANCE- :-OP. THE
REREGISTRATION OF i-'-.f/flCIDE PRODUCTS
Fi'NA.MIFHO? ,
AS THE ACTIVE I ;JGREDJ £MT
CASE NUMDEP.t GC 033:;
CAS NUMBER: 22224-32-6
JUNE, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
540/0451
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TABLE OF CONTENTS
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APPENDICES
I. DATA APPENDICES
Guide to Tables 73
Table A 75
Table B 103
II. LABELING APPENDICES ' .
Summary of label requirements and table 109
Physical/Chemical Hazards Labeling Statements 117
Storage Instructions 118
Pesticide Disposal Instructions 119
Container Disposal Instructions 120
III. USE INDEX APPENDIX 121
I IV. BIBLIOGRAPHY APPENDICES 145
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 160
EPA Form 8580-1 FIFRA i3(c)(2)(B) Summary Sheet
EPA Form*8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
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i. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
/registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
roan and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
*The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard/
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position/ the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels; ' •
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
I In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-In (DCI) provisions
of FIFRA set:. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
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the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible
unreasonable adverse effects on man or the environment.
This requirement continues as long as the products are
registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of chemical
The following chemical is covered by this Registration
Standard:
Common name: Fenamiphos
Chemical name: O-ethyl-0-(3-methyl-4-methyl-thiophenyl)-
isopropylphosphoramidate
CAS number: 22224-92-6
OPP (Shaughnessy) number: 100601
Empirical formula: Ci3H22N03PS
Trade names: Nemacur® 15G, Nemacur® 3
Basic registrant: Mobay Chemical Company
B. Use Profile
Type of Pesticide: Systemic Nematicide/lnsecticide
Pests Controlled: Nematodes, Thrips
Registered Uses: terrestrial food crops, terrestrial
non-food sites
Predominant Uses: field and vegetable crops, orchards,
vineyards, non-bearing orchards,
nursery stock, ornamentals
Mode of Activity: Organophosphate/Cholinesterase Inhibitor
Formulation Types Registered:
85% Nemacur® Technical
72.3% Nemacur® Concentrate
Nemacur® 3 EC (3 Ib/gal emulsifiable concentrate)
Nemacur® 2 EC (2 Ib/gal emulsifiable concentrate)
Nemacur® 15 G (granular)
Nemacur® 10 G (granular)
Nemacur® 5 G (granular)
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Methods of Application: Soil TtreatLaiasinl. i>y ground spray
equipment/ by granular agpanlication equipment or by
incorporation into irrigatiaac water. Soil incorporation
or irrigation immediately afttcr toreattnnent is required.
The EC formulation is currently -a ^restricted use pesticide
and applicators must be r«T±ifiaed car \un6er direct
supervision of a certified aggplirariboar..
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III. AGENCY ASSESSMENT
A. SUMMARY
Based on the review of the available data, the Agency has
reached the conclusions set forth in this Standard. A summary
of those conclusions follows. A more detailed discussion is
contained in the remainder of this chapter.
1. The major hazard concern is the potential for acute
toxicity to humans and to fish and wildlife from exposure
to formulated fenamiphos products. Technical fenamiphos
is acutely toxic to laboratory animals, Toxicity
Category I, by the oral, dermal, and inhalation routes
of exposure. It is also very highly toxic to birds as
well as to cold and warm water fish. Fenamiphos has
also been shown to cause reproductive impairment in
waterfowl and upland game birds. Field kills (birds and
mammals) have occured in many instances in areas after
fenamiphos application. All uses of fenamiphos exceed
restricted use criteria for fish and wildlife; 1/5
the acute oral LDjQ for mammals, 1/5 the subacute dietary
I LCso for birds, and 1/10 the acute 1X50 for aquatic
organisms. The Agency has concluded that the risks to
fish and wildlife associated with unrestricted use of
fenamiphos constitute unreasonable adverse effects;
therefore, all products are being restricted.
2. Studies using both the granular and spray formulations
of fenamiphos according to label directions have shown
some avian and mammalian mortality. These studies
suggest that soil incorporation and/or irrigation
immediately following application will reduce hazards
to non-target avian and mammalian species. A terrestrial
field study is necessary to determine if the hazards
indicated by laboratory and simulated field studies are
below levels of concern for mammalian and avian species
under actual use conditions.
3. Both aerial application of fenamiphos as well as runoff
exposure pose a potential hazard to fish species indigenous
to small lakes, ponds, and streams. Aquatic contamination
from aerial application could occur when fenamiphos is
applied as a broadcast spray to crops irrigated by
interconnected waterways and could result in residues
that exceed LCso values. Estimated environmental
concentrations for runoff also exceed LCso values.
Simulated and actual field testing of aquatic organisms
is required to assess potential exposure and toxicity to
aquatic organisms.
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4. Fenamiphos is not oncogenic in rats or mice. The dietary
cholinesterase no-observable-effect level (NOEL) for
fenamiphos is 1.0 ppm for both rodents and non-rodents.
No adverse reproductive effects were observed in a
3-generation rat reproductive study. Evidence regarding
developmental effects resulting from fenamiphos are
inconclusive. Teratology studies in the rat and rabbit
are required. Fenamiphos was negative for mutagenic
effects in the test systems assayed.
5. Many of the tolerances are supported by residue data.
However, data are required for garlic, soybeans, grapes,
bananas, cocoa beans, cottonseed, peanuts, pineapple,
tobacco, and nonbearing orchard crops. The adequacy of
tolerances for residues in animal commodities will be
assessed after required animal metabolism data and
residue data for feed items are submitted and reviewed.
A provisional acceptable daily (PADI) intake has been
set at 0.00025 mg/kg/day. This is based on the
no-observable effect level (NOEL) from a 2-year dog
feeding study of 0.025 mg/kg/day (1 ppm) for cholin-
esterase inhibition, and an uncertainty factor of 100
which accounts for the lack of an acceptable teratology
study. The Theoretical Maximum Residue Contribution
(TMRC ) for the U.S. population average based on anticipated
residues and percent crop treated, is 0.00011 mg/kg/day
which corresponds to 42% of the PADI. It is possible
that resolution of the teratology data gap will allow for
a lower uncertainty factor which will result in a higher
ADI and consequently a lower percentage of the ADI
occupied by the TMRC.
6. Except for hydrolysis and photodegradation studies
in water, the available data are insufficient to fully
assess the environmental fate of fenamiphos.
Additional enviromental fate data are required.
The potential for fenamiphos to reach ground water
cannot be assessed until the acceptable environmental
fate studies are received and reviewed by the Agency.
As a result of this review, the Agency has identified data
necessary to further evaluate the environmental and human
risks associated with the use. of fenamiphos. These data
must be submitted in order to maintain registrations of
products or register new products containing fenamiphos. A
summary of these data gaps appears in Table 1. Note that
this is only a summary and complete details can be obtained
by referring to the tables in Appendix I.
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The Agency has determined that certain label restrictions
or revisions are necessary in order for fenamiphos products
to remain in compliance with FIFRA. These include:
Restricted Use Classification
Environmental Hazards Precautions
Endangered Species
Reentry Interval
Protective Clothing
Chapter IV, Section D, contains the specific wording for
each of the labeling statements and identifies the products
to which each labeling statement applies.
Chapter IV, Section A, Regulatory Position and Rationale,
discusses the Agency's position regarding fenamiphos.
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TABLE 1
SUMMARY OF DATA GAPS FOR FENAMIPHOS
(Refer to Appendix I, Data Tables, for detailed information
and due dates.)
Product ChemAstrys All
Residue ,Chemis,try;
Animal Metabolism
Residue Analytical Methods (plants and animals)
Storage Stability Data
Residue Studies
Environmental Fate:
Photodegradation (soil)
Aerobic and Anaerobic Soil Metabolism
Leaching and Adsorption/Desorption
Volatility (lab)
Soil Dissipation
Rotational Crops (confined and field)
Fish Accumulation
Spray Drift Droplet Spectrum and Field Evaluation
Reentry
Toxicology:
21-Day Inhalation (rat)
Teratology (rat and rabbit)
Mutagenicity
Metabolism
Ecological Effects:
Simulated and Actual Field Testing (birds and mammals)
Freshwater Fish Toxicity
Freshwater Invertebrate Acute Toxicity
Acute Toxicity to Estuarine and Marine Organisms
Fish Early Life Stage
Aquatic Invertebrate Life Cycle
Fish Life Cycle
Aquatic Organism Accumulation
Simulated and Actual Field Testing Aquatic Organisms
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B. PRELIMINARY RISK ASSESSMENT
Toxicological Studies - FenamiphQS. Several data gaps
exist for fenamiphos so definitive conclusions cannot be
reached for certain toxicological effects until additional
data is received and reviewed. The following assessment
is based on the data available.
1. Acute Toxicity and Irri_tation Studies. Adequate
acute studies exist to define the acute toxicity of
fenamiphos products. Technical fenamiphos is acutely
toxic, (Toxicity Category I), by the oral route
(LD5Q 2.7 mg/kg), dermal route (1*050 178.8 mg/kg),
and inhalation route (LCso 0.1 mg/L) of exposure.
Technical fenamiphos is slightly irritating to the
eye (Toxicity Category III) but is not a dermal
irritant (Toxicity Category IV). Technical
fenamiphos is not a dermal sensitizer or a
delayed neurotoxicant.
No further acute toxicity studies are required at
this time.
2. S_ubchrqni_c_ Testing,
Oral (Rodent,, N on-Rodent). Studies:
In a 90-day feeding study* fenamiphos was fed to
Wistar rats at levels of 0, 4, 8, 16, and 32 ppm for
90 days. There was no mortality at the levels fed
but cholinergic signs of toxicity were observed in
animals at the 32 ppm level. A dose-related decrease
in plasma cholinesterase values by 34 to 44 percent
was reported in female rats for dietary levels of 8,
16, and 32 ppm. Maximum cholinesterase inhibition
was observed within the first week of the study
for males and by the eighth week for female rats.
Erythrocyte cholinesterase inhibition was observed
for animals fed dietary levels of 16 and 32 ppm.
The no-observable-effect level (NOEL) for
cholinesterase inhibition is 4 ppm. No significant
difference in male or female relative organ weights
between the control and test groups was reported.
No histopathological findings were reported as being
attributed to the test material.
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In a second subchronic study , Beagle dogs were
fed dietary levels of 0, 1, 2, and 5 ppm fenaroiphos
for 90 days. A decrease in body weight gain was
reported for females at the highest dose level
(5 ppm). Plasma cholinesterase was inhibited by
more than 20 percent for dietary levels of 2 and
5 ppm with a greater than 20 percent decrease in
erythrocyte cholinesterase activity reported for
the 5 ppm level. Cholinesterase inhibition was
dose related and occurred during the fourth week
of the study. The NOEL for cholinesterase'
inhibition is 1.0 ppm.
No further subchronic oral studies are required
at this time.
Dermal Studies,. An aqueous formulation of 89.8%
technical fenamiphos was applied to New Zealand
rabbits at 0, 0.5, 2.5 and 10 mg/kg body weight
for a 6 hour exposure 5 days a week for 3 weeks.
Half of the animals were abraded. A decrease in
body weight gain was observed for both sexes at the
highest dose tested, 10 mg/kg day. A decrease in
alanine aminotransf erase was reported at the 2.5 and
10.0 mg /kg/day levels of 33 and 20 percent,
respectively, in female rabbits. Plasma and brain
cholinesterase were depressed at 2.5 and - —
10 mg/kg/day in female rabbits. Plasma and
erythrocyte cholinesterase in male rabbits and
erythrocyte cholinesterase in female rabbits were
decreased at 10 mg/kg/day. The NOEL for plasma,
erythrocyte or brain cholinesterase inhibition is
0.5 mg/kg/day.
No further subchronic dermal studies are required
at this time.
There are no 90-day subchronic dermal toxicity studies
on f enamiphos. The registered uses of f enamiphos do
not require this study.
.Studies. A 21-day inhalation study is
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required because r'enamiphos is registered for use
on tobacco.
Ne_urQtoxi_c_ity_ .S_tu_di_es_. There are no subchronic
neu r otox i city studies on fenamiphos. Fenamiphos was
negative for neurotoxicity in the acute delayed
neurotoxicity study and is without evidence of
delayed neurotoxicity in other mammalian species.
Therefore, a subchronic neurotoxicity study is not
required.
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3- Chronic Testing
Chronic .Tpxicity Studies. There are sufficient
data available to 'deffi ne the long term effects
of fenamiphos.
Fenamiphos was fed to Fischer 344 rats (50/sex/group)
for 2 years at dietary levels of 0, 2, 10, and 50
ppm. A decrease in body weight gain was reported
for the 50 ppm level accompanied by a transient
decrease in food consumption for female rats of the
high dietary level (50 ppm). Of the organs weighed,
at the termination of the study a decrease in absolute
liver weight and an increase in absolute and relative
lung weights were reported for the 50 ppm level. A
dose related decrease in plasma and erythrocyte
cholinesterase activity was observed for males and
females of all three dietary levels by the sixth
week of the study. Over the duration of the study
the plasma cholinesterase values at 2 ppm were depressed
by 6 to 38 percent in males and 22 to 42 percent in
females, while erythrocyte cholinesterase was depressed
by 2 to 7 percent in males and 3 to 11 percent in
females. Brain cholinesterase activity for males at
the low-dose level (2 ppm) was depressed by 5 percent
with the female values comparable to the control
cholinesterase values. The cholinesterase NOEL
for this study is less than 2 ppm. However,
in a concurrent subchronic rat feeding study dietary
levels of 0.36, 0.6 and 1.0 ppm were fed to male and
female rats for 90 days without effect on plasma,
erythrocyte, or brain cholinesterase values. The
rat cholinesterase NOEL for fenamiphos is 1.0 ppm.
The systemic NOEL from the two year rat study is
10 ppm.
No dose-related increase in neoplastic and non-
nepplastic histopathological lesions was observed
from feeding dietary levels of 2, 10, and 50 ppm to
male and female rats for 2 years.
Fenamiphos was fed to 8 month old Beagle dogs (four/
sex/group) at dietary levels of 0, 0.5, 1.0, 2.0,
5.0, and 10 ppm for 2 years. No effects were observed
for the following parameters at levels up to and
including 10 ppm: appearance, growth rate, food
consumption, mortality, hematology, and clinical
chemistry. No gross (including organ weights) or
histopathological changes were attributed to dietary
levels of fenamiphos. Plasma cholinesterase activity
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was depressed at the 2, 5, and 10 ppm dietary levels
with erythrocyte cholinesterase activity depressed
at the 5 and 10 ppm levels in both sexes. Brain
cholinesterase values were not determined.
In a subsequent subchronic feeding study
dietary levels of 0, 0.6, 1.0, and 1.7 ppm were fed
to 4 month old Beagle dogs (4/sex/group) for 100
days. Plasma cholinesterase activity was depressed
by 28 to 35 percent only in males fed the 1.7 ppm
level. Erythrocyte and brain cholinestera.se activity
were not affected at any of the dietary levels tested.
The cholinesterase NOEL based on a 2-year dog
feeding study is 1.0 ppm with the lowest effect
level for cholinesterase inhibition determined to be
2 ppm. The systemic NOEL based on a 2-year dog
feeding study is 10 ppm, the highest level fed.
No further chronic toxicity studies are required at
this time.
Oncogenicity> There are sufficient data available
to determine that fenamiphos is not oncogenic in
rats or mice.
Fischer 344 rats (50/sex/group) were fed dietary
levels of 0, 2, 10, and 50 ppm for 2 years. No
dose-related increase in neoplastic or nonneoplastic
histopathological lesions was observed as compared
to the control animals.
In another study, CD outbred strain albino mice
(50/sex/group) were fed dietary levels of 0, 2, 10
and 50 ppm for eighteen months. Statistically
significant increases in mean relative brain weight
and decreased body weight were reported in females
fed 50 ppm. Fenamiphos was not shown to be
oncogenic.
No further oncogenicity studies are required at
this time.
Teratology. Sufficient data are not available to
determine the teratogenicity of fenamiphos in
rabbits.
New Zealand rabbits (20 females/group) were administered
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88.8% fenamiphos orally in corn oil at doses of 0, 0.1,
0.3, and 1.0 rag/kg body weight from days 6 to 18 of
gestation. Maternal toxicity was observed at the
0.3 and 1.0 mg/kg dosage levels consisting of a
decrease in mean body weight gain accompanied by a
90 and 88 percent survival, respectively. Liver
lesions were observed at the 1.0 mg/kg level. Mean
fetal weight was slightly depressed at 1.0 mg/kg.
One dam at 0.3 mg/kg aborted one dead pup on day 25.
Two dams at 1.0 mg/kg aborted on days 26 and 28 with
eight dead pups and seven late resorptions, respec-
tively. In addition, one dead fetus was observed in
each of two litters at the high-dose during Cesarean
section. A significant increase in the incidence of
chain-fused sternebrae was noted at 1.0 mg/kg, with
a finding of five fetuses in three litters. There
was also one fetus in one litter at 0.3 mg/kg with a
finding of chain-fused sternebrae. Fenamiphos caused
an increased incidence in a minor anomaly (left
carotid artery arising from the innominate) at all
three dose levels, which was greater than the
spontaneous occurrence in the historical controls.
Although apparently compound-related, the response
did not increase in a dose-response relationship.
Owing to the physical status of all dams in the
study (evidence of ascites and pitted kidneys) a
clear relationship between compound administration
and effect cannot be established and the study is
considered supplementary. Therefore, the biological
significance of the responses observed roust be clarified.
A rabbit teratology study is required.
There are not sufficient data available to assess
the teratogenicity of fenamiphos in rats. A
rat teratology study is required.
Rep r o duct ion. An adequate study in rats assessing
the reproductive effects of fenamiphos over at least
two generations is available. Thirty-three-day
old FB30 rats (10 males/20 females/group) were fed
dietary levels of 0, 3, 10 and 30 ppm through three
generations. Dietary levels of 3 and 10 ppm had no
effect on behavior or body weight gain of the males
or females. Male rats of the F2b generation fed
30 ppm gained less weight than the control males of
the same generation. There was no difference between
the test and control animals with respect to fertility,
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litter size, average weight of pups at birth, and
lactation performance of the dams. The reproduction
NOEL is 30 ppra.
No further reproduction studies are required at
this time.
Muta_ge_n ic ity Studies_. Fenamiphos was negative when
tested in the CHO/HGPRT mutation assay and in the
dominant lethal mutation assay. Data are'-required
however, to assess direct DNA damage.
4. Metabolisjn. Studies. Data are not available
to determine the degree of tissue accumulation and
elimination in rats resulting from multiple doses
of fenamiphos. The major metabolites of fenamiphos
have been identified from single dose studies as
the sulfoxide and sulfone. However, the metabolic
pathway for the desisopropyl metabolites needs to
be defined.
A guideline multiple dose rat metabolism study is
required.
The sulfoxide, sulfone, and des-isopropyl analogs
of fenamiphos are as highly toxic as the technical
material; the phenolic metabolites are low in
acute toxicity.
5. Spec i a 1 S_tu4i e.s_.
Antidotal. Sufficient data are available to
determine the efficacy of atropine and 2-PAM in
treating fenamiphos poisoning in male and female
rats.
Atropine increased the LD5Q of fenamiphos by five
times and 2-PAM increased the LD5Q of fenamiphos by
six times the value for untreated animals. The
combination of atropine and 2-PAM were no more
protective than either compound alone.
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6. Ri.sk Assessment
0 Fenamiphos is acutely toxic to laboratory animals,
Toxicity Category I, by the oral, dermal, and
inhalation routes of exposure.
0 Fenamiphos is not a delayed neurotoxicant.
0 Fenamiphos is not oncogenic in rats or mice.
0 No dose-related increase in neoplastic and non-neoplastic
histopathological lesions was observed from feeding
dietary levels of 2, 10, and 50 ppm to male and female
rats for 2 years. No gross or histopathological
changes were attributed to feeding dietary levels of
.5 to 10 ppm to Beagle dogs for 2 years. The dietary
cholinesterase NOEL for fenamiphos is 1.0 ppm for
both rats and dogs.
0 There is not sufficient data to fully assess the
teratogenic potential for fenamiphos. Further
studies in the rat and rabbit are required.
0 No adverse reproductive effects were observed in a
3-generation rat reproductive study.
0 Fenamiphos was not mutagenic in the test systems
assayed.
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C. OTHER SCIENCE FINDINGS
Environmental Fate. Available data are insufficient to fully
assess the environmental fate of fenamiphos. Except for
data pertaining to hydrolysis and photodegradation in water,
the information discussed below is considered supplementary
and is provided from studies that did not fulfill the data
requirements for registration; the later studies must be
repeated.
1. Hydrolysis. A radiolabeled hydrolysis study demon-
strates that fenamiphos degrades with half-lives of 7 to
14 days at pH 3, >30 days at pH 9, and appears to be
stable at pH 7 when incubated in the dark at 30°C.
This data suggests that fenamiphos is relatively stable
in neutral and alkaline solutions. The primary degra-
dation product in the pH 3 solution was deaminated
fenamiphos (74-78%). Degradates identified in the
methylene chloride extracts from pH 3, 7, and 9 solutions
included fenaroiphos sulfoxide, fenamiphos sulfone,
fenamiphos phenol, fenamiphos sulfoxide phenol, and
fenamiphos sulfone phenol. No further hydrolysis
studies are required.
2. Photodegradation in Water* A radiolabeled degradation
study demonstrates that fenamiphos degrades with a half-
life of 2 to 4 hours in pH 7 buffered water irradiated
with artificial light. After 24 hours of irradiation,
fenamiphos accounted for approximately 4% of the
applied radioactivity, fenamiphos sulfonic acid phenol
for approximately 19%, fenamiphos sulfoxide for
approximately 17%r fenamiphos sulfonic acid for 6%,
and fenamiphos sulfoxide phenol for 1%. No further
water photodegradation studies are required.
3. Photodegradation in Soil. Ring-labeled fenamiphos
degraded with a half-life of <1 hour on sandy loam soil
irradiated with artificial light. After 48 hours of
irradiation, fenamiphos and the degradates fenamiphos
sulfoxide and fenamiphos sulfone accounted for approxi-
mately 12, 55, and 6% of the extractable radioactivity,
respectively. This study does not fulfill data
requirements because the material balance was incomplete;
not all the material was accounted for. Data on the
photodegradation of fenamiphos in soil are required.
4. Aerobic Soil Metabolism. Available data are
inadequate to assess the metabolism of fenamiphos
in aerobic soil. The study'does not fulfill data
requirements because the soil was not characterized
and the material balance was incomplete. Data on the
metabolism of fenamiphos in aerobic soil are required.
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5. Anaerobic Soil Me.tabolism. Data on the metabolism of
fenamiphos in anaerobic soil are required.
6. Leaching and Ads.o.rp_ti.o_n/DTe_s_orp_t_ic>n Studies. Available
data (8 studies) are inadequate to assess leaching
and adsorption/desorption. Data on leaching and
adsorption/desorption of fenamiphos are required.
7. Laboratory VQl.ati.l.ity, Studies. No data were reviewed.
Laboratory volatility Studies are required.
8. Field Volatility Studies. The data requirement is deferred
pending receipt of acceptable laboratory volatility studies.
9. Terre.s trial Field, Dissipation Studies^ Available data
Til studies) are inadequate to assess terrestrial field
dissipation. Data on the terrestrial field dissipation
of fenamiphos are required.
10. Aquatic Field Dissipation. No data were reviewed;
however, no data are required because fenamiphos has
no registered aquatic food crop, aquatic nonfood,
or aquatic impact uses.
11. F.orestjry Dis_sij>ation Studies, jqo data were reviewed;
however, no data are required because fenamiphos has
no forestry uses.
12- Long^-1erm F ieJL d Djssipation S_tudie_s_. No data were
reviewed. The data requirement is deferred pending
the receipt of acceptable field dissipation data.
13. Confined AccumulatiQn[Studi.es .on Rotational Crops.
Radio-labeled fenamiphos residues accumulated in mustard,
sugar beets, and a grain crop planted 31 and 115 days
after formulated radio-labeled fenamiphos was applied
at 6 Ib ai/A to a loamy sand soil. Parent fenamiphos
was not detected in any crop; two degradates, fenamiphos
sulfoxide and fenamiphos sulfone were detected at
0.01-0.18 and 0.01-0.23 ppm, respectively in all crops.
Radio-labeled fenamiphos residues dissipated with a
half-life of 308 to 328 days in the loamy sand soil.
This study does not fulfill data requirements because
the test substance was not analytical grade, residues
in the soil were not characterized, residues in the
crops were not adequately characterzied and meteoro-
logical data were inadequate. Therefore, data on the
accumulation of fenamiphos .in confined rotational crops
are required.
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19
14. Field Accumulation Studies on Rotational Crops.
Fenaraiphos residues were not detected in rotational
radish, snap beans, or sorghum planted approximately
364 days after fenaroiphos was applied at 1.5 and 3.0 Ib
ai/A to silty clay loam soil. Fenamiphos residues were
£0.06, £0.03, 0.01, and <0.01 in mature rotational crops
(turnips, blackeyed peas, and corn) planted approximately
30, 90, 120, and 364 days, respectively, after fenamiphos
was applied at 1.5 to 6.0 Ib ai/A to sandy soil. This
study does not fulfill data requirements because the
test substance was not characterized, the analytical
method was nonspecific, residues in soil and crops were
not characterized, and residues in the soil were not
analyzed at the time of treatment. Data on the accumu-
lation of fenamiphos in field rotational crops are
required.
15. Accumulation Studies on Irrigated Crops. Data on the
accumulation of fenamiphos in irrigated crops is
required.
16. Accumulation Studies in Fish. The one study reviewed is
inadequate. Data on the accumulation on fenamiphos in
fish are required.
, 17. Field Accumulation Studies on Aquatic Nontarget Organisms.
No data were reviewed; however, no data are required
because fenamiphos has no forestry, aquatic noncrop,
or aquatic impact use.
18. Groundwater. The potential for fenamiphos to reach
ground water cannot be determined at this time. Of the
seven studies required under the Groundwater Data Call-in,
only two, hydrolysis and photodegradation in water, met
guideline requirements. The Agency will evaluate the
potential of fenamiphos to contaminate ground water after
it has received and evaluated the following required
data: photodegradation in air, aerobic and anaerobic
metabolism, mobility, and field dissipation. The
sulfoxide and sulfone metabolites of fenamiphos are
included in the National Survey for Pesticides in Drinking
Water, in lieu of parent fenamiphos, as the parent
readily degrades.
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20
Ecolggical. Effects. Available data are insufficient to
completely evaluate the ecological effects of fenamiphos.
Data as set forth in Appendix I, Table A are either required
or reserved pending further evaluation. The following
conclusions can be made based on available data.
!• Toxicity to Birds and Mammals.
Technica 1 JFenamipho s. Fenamiphos can be characterized
as very highly toxic to the bobwhite quail (LDso
1.6 mg/kg, LCso 38 ppm) and highly toxic to the mallard
duck (LCso 316 ppm). Results of a bobwhite quail
reproductive study demonstrated that dietary exposure of
8 ppm reduced chick survival by 31 percent with a NOEL
of 2 ppm. Results of a mallard duck reproductive study
demonstrated that dietary exposure of 16 ppm reduced
feed consumption and egg production with a NOEL of 8
ppm. These data indicate that fenamiphos causes some
reproductive impairment in both upland game birds and
waterfowl at exposure levels of 2 and 8 ppra,
respectively.
Granular 15 G. Applications of Nemacur* 15G at a rate
of 134 Ibs. ai/acre to turf, without irrigation,
resulted in 70 and 15 percent mortality to English
sparrows and bobwhite quail, respectively, when these
birds were penned on the treated area. Even with
1/2 inch irrigation immediately following application,
50 percent of the English sparrows penned on treated
plots died. Little or no hazard to penned birds was
reported when Nemacur* 15G was both soil incorporated
and unincorporated after band application (27 oz.
formulation/1,000 feet of row) and incorporated after
broadcast treatment (40 Ib. formulation/acre).
Results of these studies suggest that soil incorporation
of granules reduces hazards to avian species.
Emulsifiable Concentrate (35%). Applications of
Nemacur* 3 (35% SC) at rates of 6, 10, and 20 Ibs. ai/
acre and soil incorporated 2 to 3 inches resulted in
approximately 10% mortality to bobwhite quail. In another
small pen study with pheasants and rice birds, application
of Nemacur* 3 at 5 Ib. ai/acre on pineapples, resulted in
approximately 25% mortality to the rice birds. Both
significant avian and mammalian mortality was reported
when 26 acres of orchard were sprayed with Nemacur* 3
at a rate of 23.5 Ibs. ai/acre without soil incorporation.
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21
Results of the above studies suggest that soil incorpor-
ation and/or irrigation will somewhat reduce hazards to
non-target avian and mammalian species.
Because of study design deficiencies, none of the field
studies discussed above fulfills the data requirements.
A terrestrial field study is being required to determine
if the hazard indicated by these laboratory and field
studies are below the levels of concern for mammalian
and avian species under actual use conditions
(Appendix I, Table A).
2« Toxicity to Fish, Aquatic Invertebrates, and Estuarine/
Marine Organisms.
Technical Fenamiphos^. The lowest 96-hour LCso for bluegill
sunfish was determined to be 9.6 ppb, while the lowest
96-hour LCso for rainbow trout was 72.1 ppb. These data
suggest that fenamiphos is very highly toxic to both warm
and cold water fish. The lowest 96-hour LCsos for the
bluegill sunfish for the two major degradates of the parent
material were determined to be 2,000 and 1.173 ppb for the
sulfoxide and sulfone group. The major metabolites of
fenamiphos are considered to be moderately toxic to warm
water fish.
Granular 15 G. One study, involving two fish species, was
conducted using the 15G formulation. The 96-hour LCso
values were determined to be 151 and 563 ppb for the blue-
gill sunfish and rainbow trout, respectively. Based on
the LCso values listed above, the 15G formulation appears
to be less toxic than the technical but still highly toxic
to both warm and cold water fish.
The following additional studies are being required:
an acute LCso ^or fish using the 21 and 35% spray concen-
trate products; an acute LCso f°r freshwater invertebrates
using the technical and formulated products; an acute LCso
for estuarine and marine organisms; fish early life stage;
fish life cycle; aquatic invertebrate life cycle; acquatic
organism accumulation; and simulated and actual field
testing of aquatic organisms (Appendix I, Table A).
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22
3. Ecologicra.! Effects Hazard Assessment. Because of the
ecotoxicological and environmental Yate data gaps, there
are insufficient data to fully assess the direct and
indirect hazards of fenamiphos to nontarget fish and wildlife
species. However, there are sufficient data to make certain
preliminary statements about the acute and chronic hazards
of fenamiphos to these species.
a. Terrestrial Aazard Ass_e_s_s_ment .
(1). Granular Formulation. Exposed fenamiphos granules
pose a hazard because of their high tpxicity to both
mammalian and avian species. Field studies conducted
with fenamiphos have documented that non-target birds
and mammals can ingest lethal doses of granular
pesticides during the course of their normal feeding
activities. Agency-sponsored field studies also indicate
that bird species which typically forage the soil for
food or grit may also be exposed to soil incorporated
granules. (Also, the use of sprinkler irrigation, to
incorporate granules, may result in high levels of
fenamiphos being concentrated in small puddles or wet
spots which may also pose hazards to nontargets when
they are drinking).
The hazards to nontarget mammalian and avian species
posed by granular fenamiphos (15G) are based on the
maximum application rates of 66 to 133 pounds formulated
product (9.9 to 20.0 Ib ai/A) per acre to tobacco,
fruit trees, and ornamentals (soil and turf) and the
LD5Q for the most sensitive organisms tested. Label
directions call for the 15G formulation to be soil
incorporated 2 to 4 inches deep or irrigated into the
soil immediately following application.
Although soil incorporation may reduce the potential
for nontarget exposure, it does not eliminate it.
Studies have shown that even with the roost modern
equipment, some granules still remain on the surface.
Erbach and Tollerfson (1981) using commercially
available equipment found that 5 percent of the
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23
granules applied remained on the soil surface.
In another study/ counts conducted immediately after
incorporation revealed that both row areas (x =
70 granules/sg ft) and end row turn areas (x =
344 granules/sg ft) contained large numbers of
exposed granules.
One way of assessing the potential for this hazard,
under field conditions, is to compare the amount of
toxicant available on a square foot basis with the
acute oral LDso value(s) for the species likely to
be exposed. The closer the value is to the LDso the
greater the degree of hazard. Support for this
approach can be found in the literature. Dewitt (1966)
after conducting a quail field study concluded/ "losses
of birds may be expected if the quantity of toxicant
per square foot equals or exceeds the quantity causing
deaths of quail in short term feeding tests." Additional
support is provided by Tucker (1972) who has reported
that field kills have occurred in many instances when
the amount of toxicant applied per acre exceeded 50,000
LD5QS (equal to approximately 1 LDso per square foot).
Using the recommended application rate of 133 Ib
product/acre (95 percent soil incorporation assumed)
and the average weight of one granule/ 0.093 mg, the
number of granules per square foot has been calculated
to be 745 granules (10.43 rog ai) per square foot
(Table 2).
(a). Avian Hazards,. The primary routes of exposure
tx> avian species are expected to be from the
ingestion of granules and grit and drinking
contaminated water. Based upon the acute oral
LD5Q value for bobwhite quail (16.0 rag/kg of
15G) and the average weight of the 15G granule
(.093 mg)/ the number of granules equivalent to
the LD5Q values for six avian species has been
determined (Table 3).
When these values are compared to the average
number of granules per sq. ft. resulting from
the maximum application rate/ 745 granules/sq.
ft. (Table 3), it appears that there is little
margin for safety especially for small birds
that forage for food or grit on the soil surface.
In the case of the bobwhite quail which has the
largest LDso value of the six species in the
table (equivalent to 34.4 granules)/ the average
-------
TABLE 2
AVIAN TOXICITY/USE RATE CORRELATION
Nemacur* 15G (15% AI GRANULAR FORMULATION)
APPLICATION RATE OF 20 LB AI/ACRE (95% SOIL INCORPORATION ASSUMED
1 LB AI/ACRE)
Organism
BobMhite
quail
House
sparrow
ReoVinged
blackbird
Body
Weight
(g)
200 16
20 16
50 16
(mg prod/
kg)
.0 mg prodAg
(2.4 mg aiAg)
.0 mg prodAg
(2.4 rag aiAg)
.0 mg prodAg
(2.4 mg aiAg)
LD50
(mg prod/,
animal)-:/
3.2 mg prod/
animal
0.32 mg prod/
animal
0.80 mg prod/
animal
Quantity of
Product/
Sq. Ft. =1
69.3 mg
69.3 mg
69.3 mg
Lethal No. of
15G Granules
Required to .
Equal LD50 =*
34.4
3.4
8.6
No of granules/
Sq. Ft.
I/
745
745
745
LDsp
Equivalents/
Sq. ft.!/
21.7
217.0
86.6
IV)
-fcfc
Calculation for the Bpbwhite Quail
I/ LDso » 16.0 rag/kg prod x .2 kg » 3.2 mg prod/animal
^/ (133 Ib prod/acre) x (454,000 mg/lb) = 60,382,000 mg prod/A
(60,382,000 mg/prod/A)/(43,560 ft2/A) » 1386 mg prod/ft2 x .05 - 69. 3 mg. prod/ft.2
3/ (3.2 mg prod/animal)/(.093 mg/granule) =34.4 granules/animal
T/ (69.3 mg prod/ft*)/(0.093 mg/granule) - 745 granules/ft2
^f \ w«r • *r tl9y ^*».%x%*^ *. w^ if \*** T ^>* •••^/ ^*- *** «vi-^^* / ' -*•* ^L^VI ivi Jbv»^^ «- \-
"S/ (69.3 mg prod/ftz)/(3.2 mg prod/animal) = 21.7 LD5Q equivalents/ft
or (145 aranules/sq ft)/(34.4 qranules/LDcn) = 21.7 LOen eouivalen
5Q equivalents/ft
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25
TABLE 3
NEMACUR* 15G (15 % AI)
HAZARD TO SIX SPECIES OF NONTARGET BIRDSl/
Number of _(_1.5G) Granules
Equal to
Species
Body
Weight
(9)
Bobwhite (adult) 200
Bobwhite (14-day) 30
Animal
3.20
0.48
34.4
5.1
Robin
Mourning dove
House sparrow
Redwing blackbird
Grasshopper sparrow
80
100
20
50
13.9
1.28
1.60
0.32
.80
.22
14.0
17.2
3.4
8.6
2.3
I/ Utilizing bobwhite quail LDso of 16.0 mg/kg (15G) or 2.4 mg
ai/kg (E. Hill, Patuxant Wildlife Research Center-Personal
Communication).
2/ Weight of one 15G granule « 0.093 mg.
T/ 16.0 mg/kg (15G) x .2 kg = 3.2 rag/animal (15G) (LD50 for 15G
~~ to bobwhite quail on per body weight basis). All other values
in this column based on the assumption that each organism
has the same sensitivity as the bobwhite quail (i.e., LDso
for each organism is 16 mg/kg (15G).
4/ Number of 15G granules
Required to equal LDso » 3.2 mg/animal .(,1,5_G)_ * 34.4
7093 granule wt
or
LDso * 16 mg/kg (15G) x 15% = 2.4 mg ai/kg.
.2 kg x 2.4 mg ai/kg * .48 mg ai/animal
Number of granules
(based on ai), required ' « .48 mg ai/animal * 34.4
to equal LDso •^14 ~™9 (granule wt)
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26
number of granules per square foot equals 21.7
LDso values, suggesting a very high degree of
hazard. Again, these values suggest that the
smaller birds, for example the house sparrow
(with 217 LD5Q equivalents per square foot),
are at the greatest degree of risk. Although
these calculations clearly indicate that this
level of exposure may put birds at risk, further
exposure analysis cannot be made without
additional data; therefore simulated and actual
field testing for birds is being required via
this Registration Standard so that an accurate
determination of risk can be made.
The Agency has also compared the potential
toxicity of fenamiphos to restricted use criteria.
The avian acute oral LD$Q of 16.0 mg(15G)/kg for
the bobwhite quail exceeds the Agency's proposed
restricted use criteria for hazard to avian species
of 50 mg/kg for granular products (U.S.E.P.A.,
"Hazard Evaluation Division, Standard Evaluation
Procedure", EPA-540/9-85-001, p. 57. June 1986).
In addition, fenamiphos exceeds the restricted
use criteria for avian species set forth in
40 CFR 162.11(c)(2)(iii)(B); exposure exceeds
1/5 the subacute dietary LCso for the bobwhite
quail. The subacute dietary LCso of 179 ppm
was calculated from the acute oral LDso of
16.0 mg/kg for the 15G formulated product and
food consumption and body weight data. The
formula for calculating the LCso is as follows:
Calculated LCso * LD5o/(food consumption/body weight)
The 15G formulation contains 150,000 ppm
fenamiphos; this dietary exposure far exceeds
1/5 the LC50 (179/5).
Finally, fenamiphos exceeds the restricted use
criteria for non-target organisms outlined in
40 CFR 162.11(c)(2)(iii)(D). As discussed above
under "Toxicity to Birds", the 15G formulation
has resulted in mortality to English sparrows
and bobwhite quail, thus exceeding the criteria
of "...minor or no discernible adverse effects...".
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27
(b). Mammalian Hazards. Possible routes of exposure
to mammals from granulated formulations are
from ingestion of granules, feeding on
contaminated vegetation/ invertebrates or
drinking contaminated water. Based on body
weight and acute oral toxicity data, the number
of granules equivalent to an LDso for four
species of mammals (Rat, Eastern Cottontail,
Grey Squirrel, and Delmarva Fox), known to
frequent agricultural areas, have been
calculated (Table 4).
The average number of granules per square foot,
745, exceeds the LD5Q for all but one of the
four species, the Eastern cottontail. In the
case of the rat, the number of granules per
square foot exceeds the LD5Q by 2.6 times.
These data suggest that in terms of the available
LDso equivalents/sq. ft., small mammals are at a
greater risk than large mammals and that very
small rodents such as Microtus, Perpmyscus, and
Reit h rp_d oji t omy s are very likely to be exposed
to lethal levels of fenamiphos from the 15G
formulation.
Laboratory studies have shown that the sulfoxide
is as toxic as the parent material. Environmental
fate data show that fenamiphos and its metabolites
are picked up systeraically by plants and that
sulfoxide residue may be present in certain
soil for up to 2 years after application.
These data suggest that small mammals feeding
on contaminated vegetation are also likely to be
exposed to fenamiphos and/or its metabolites.
This is another issue that should be explored
under simulated and actual field conditions.
The above discussion clearly indicates that
mammals can be potentially exposed to fenamiphos
either from ingestion of granules or from
feeding on contaminated vegetation at levels
that may put them at risk. Further exposure
analyses cannot be made without additional
data; therefore simulated and actual field
testing for •mammals are being required via this
Registration Standard so that an accurate
determination of risk can be made.
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28
TABLE 4
fWMALIAN SPECIES SENSITIVITY PROFILE I/
NEMACUR* 15G (15% ai)
HAZARD TO POUR SPECIES OF NOWIARGET MAW1ALS
Species
Body LDcQ as
Weight Mg ai/sf
(g) Animal*/
Number of Granules
Equal to
15G
15G
Multiples of!/
^50
Equivalents/
Sq. Ft.
Rat
Adult
400
4.0
286
57
2.6
Eastern
Cottontail
Adult
Weaned young
(20 days old)
1100
85
11.0
0.85
785.7
60.7
157.1
12.1
.94
12.3
Grey Squirrel
Adult Female
Weaned Young
(10 days old)
520
200
5.2
2.0
371.4
142.8
74.2
28.5
2.0
5.2
Delmarva Fox6/
Squirrel
Adult Female
Weaned Young
(8-10 wks old)
795
454
7.95
4.54
567.8
324.2
113.5
64.8
1.3
2.3
I/ Utilizing rat LDso of 10 ngAg ai.
"2/ Weight of one 15G granule = 0.093 rag.
Weight of pesticide in one granule:
0.093 rag x 15% = 0.0139 mg ai/granule.
3/ Rat LDso = 10 mg aiAg
10 mg aiAg x 0.4 kg body wt. * 4 mg ai/animal
(LDso for Rat on per body weight basis)
All other values in this column based on the assumption that each organism has
the same sensitivity as the rat (i.e., LDso for each organism is 10 ngAg ai).
4/ Number of 15G granules * 4.0 mg ai/animal = 286 granules
required to equal LDso 0.014 rag ai/granule*
5/ Restricted Use classification criterion [40 CFR 162.11(c)(2)(iii)(B)].
6/ Weight data obtained via personal communication with Gary Taylor and Dr.
Vagan Flyger of the Delmarva Fox Squirrel Recovery Team.
7/ 745(average number of granules/sq. ft)/number of granules equal to
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29
Fenamiphos also exceeds the restricted use
classification criterion for mammals (1/5 the
acute oral 1*050) by 5 to 15 times for all four
species in Table 4, indicating that unrestricted
use of fenamiphos would constitute unreasonable
adverse effects to mammals [40 CFR 162.11(c)(2)
(iiiHA)].
(2). Emulsifiable Concentrate Formulation. As
previously discussed,results of field studies suggest
that the emulsifiable concentrate spray formulations,
even when soil incorporated, cause mortality to both
avian and mammalian species. The evidence also
suggests, however, that soil incorporation does
reduce hazard to some extent.
The extent to which avian species may be exposed
and the degree of hazard from such exposure is shown
in Tables 5 and 6. This hazard assessment for the
SEC formulation was based on exposure from the maximum
application rate of 20 Ib ai/A for fruit trees, and
ornamentals (sod and turf), and dietary subacute
toxicity data for the most sensitive species tested
(bobwhite quail LCjjQ 38 Ppm). Because label directions
call for both broadcast and band applications to be
soil incorporated immediately following application,
the application rate of 20 Ib ai/A has been adjusted
to 1 Ib ai/A to account for 95% soil incorporation.
Table 5 presents the food factor calculations and
correlation of total adjusted residues with calculated
LCso values for various species. Table 6 shows
estimated dietary concentrations and the total
estimated residues for eight species of nontarget
birds.
Comparisons between expected dietary concentrations
and LC5Q values for eight species of nontarget birds
suggest the following:
1. Small insectivorous birds such as the
Carolina wren are likely to be exposed to
the highest residues of fenamiphos and as such
are the most susceptible to hazard.
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30
2. Seed-eating birds such as the Mourning dove
are likely to be exposed to the lowest residues
of fenamiphos.
3. Residues of fenamiphos exceed NOELs for
tested avian species (2 and 8 ppm for upland
gamebirds and waterfowl, respectively) and
suggest that reproductive impairment may occur
under field conditions.
4. Mortality and or/other adverse effects
associated with cholinesterase inhibition
may occur to certain species regardless of
size.
5. Total fenamiphos residues exceed the
calculated subacute dietary LC$Q for four
species.
6. As the residue calculations in Table 6
assume 95% soil incorporation (which reduces
the application rate of 20 lb€ ai/ acre to
estimated residues of 1 Ib ai/acre), it is
apparent that failure to adequately soil
incorporate broadcast or band applications
/ will greatly increase exposure and potential
for adverse effects.
7. Total fenamiphos residues exceed 1/5
the calculated subacute dietary LC$Q for all
eight species (restricted use classification
criterion, 40 CFR 162.11 (c)(2)(ill)(B)).
In addition, the emulsifiable concentrate formulation
of fenamiphos exceeds the restricted tree classification
I criteria as set forth in 40 CFR 162.life)(2)(iii)(D).
Use of the 35% EC formulation resulted in significant
avian and mammalian mortality, thus exceeding the
criteria of "...minor or no discernible adverse
effects..."-
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31
TABLE 5
CALCULATED LC50 VALUES FOR SEVEN SPECIES OF NONTARGET BIRDSi/
SpeciesV
Body Food
Weight Consumed
(gm) (gm)
Food Cons./ Calculated
Body Weight LC5Q
Percentage (ppm) 2s
1.
2.
Bobwhite quail
(Young)
Bobwhite quail
30.0
170.00
6.0
15.20
20.0
8.94
38.0
85.0
(Adult)
3.
4.
5.
6.
7.
8.
Robin
Mourning dove
Eastern cowbird
Field sparrow
Grasshopper
sparrow
Carolina wren
81.
100.
50.
13.
13.
19.
10
00
00
90
90
00
8.
11.
7.
4.
4.
6.
11
20
00
60
60
50 i/
10.
11.
14.
33.
33.
34.
00
20
00
10
10
20
••••hall
75.9
67.9
54.3
23.0
23.0
22.2
I/ All of the calculations for calculated LCso (ppm), except for
38 ppm which is the reference LC$Q, are based upon the
assumption that each species has the same sensitivity to
fenamiphos as bobwhite quail.
2/ All species considered are adult organisms, and the body
weight and food consumption values are from Kenaga (1973),
Nice (1938), and USD1, USFWS, Circular 199, 1964.
These are the theoretical dietary levels which should cause
50% mortality (LCso) using the assumption stated in (1) above
(see Kenaga (1972 and 1973)). The procedure used is:
Food Consumption (%) x Toxicant (ppm)
Body Weig
mpt
ght
Residue Level
Toxicant (mg/kg)
Body Weight/Day
£/ The food consumption value and, consequently, the food
consumption/body weight (as %) value were developed from
Kenaga (1973)r In this article the food consumption values
for a 19.0 gm three sparrow (Spizella arborea) are given as
7.11 and 5.95 gm, the mean equaling 6.53 gm. This value is
considered suitable for use with the Carolina wren's body
weight of 19.0 gm (from Nice 1938).
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^ TABLE 6 '
DIETARY CONTAMINATION AND TOTAL ESTIMATED FENAMIPHOS RESIDUES FOR EIGHT SPECIES OF NON-TARGET BIRDS
APPLICATION RATE 20 LBS AI/ACRE (95% SOIL INCORPORATION ASSUMED = 1 LB AI/ACRE)
Calculated
Species LC50
(ppm) I/
Bobwhite 38.0
quail
(14-day)
Bobwhite 85.0
quail
(Adult)
.
Robin 75.9
Mourning 67.9
dove
1/5 Calculated Food
f f^ff\ f* *
ix.z>u Lonsumea
(ppm) 2/ Animal (%)
7.6 80%
Beetles
Weevils
Grasshoppers
etc.
17.0 27%
Beetles
Weavils
Grasshoppers
etc.
15.2 40%
Caterpillars
Beetles
Weevils
Earthworms
etc.
13.6 0%
Plant
20%
Seeds:
Ragweed
Lespedeza
Corn etc.
73%
Seeds:
Ragweed
Lespedeza
Corn etc.
60%
Seeds/
Fruits:
Cherry
Dogwood
Holly
100%
Seeds:
Corn
Maximum Expected
Residues (ppm) i/
Animal Plant
58.0ppm(k) 7/ 12.0ppm(k)
58.0 ppm(k) 12.0 ppm(k)
58.0 ppm(k) 12.0 ppm(k)
58.0 ppm(k) 12.0 ppm(k)
.
Maximum Adjusted Total Residi
Residues (ppm) ^ Both Plant
Animal Plant And Animal
46.4ppm 2.4ppm 48.8ppm
15.7 ppm 8.8 ppm 24.5 ppm
23.2 ppm 7.2 ppm 30.4 ppm
0.0 ppm 12.0 ppm 12.0 ppm
Pigweed etc.
Eastern 54.3
cowbird
(Adult)
Field 23.0
sparrow
(Adult)
10.9 52%
Grasshoppers
Beetles
Caterpillars
4.6 51%
Beetles
Grasshoppers
«• » j « ^ . _ _
48%
Seeds:
58.0 ppm(k) 12.0 ppm(k)
30.1 ppm 5.8 ppm 35.9 ppm
Bristlegrass
Oats
49%
Seeds:
Crabgrass
•» i » *
58.0 ppm(k) 12.0 ppm(k)
29.6 ppm 5.9 ppm 35.5 ppm
Caterpillars
etc
Bristlegrass
Panicgrass
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TABLE 6 (continued)
DIETARY CONTAMINATION AND TOTAL ESTIMATED FT-NAMIPHOS RESIDUES FOR EIGHT SPECIES OF NON-TARGET BIRDS
APPLICATION RATE 20 LBS AI/ACRE (95% SOIL INCORPORATION ASSUMED = 1 LB AI/ACRE)
Calculated 1/5 Calculated Food Maximum Expected Maximum Adjusted Total Residues
Species LC50 LC50 Consumed _____ L . _ JfesJL_djie_s_ Jpjgn), i/n Residues .(ppm) J^ Both Plant
(ppm) I/ (ppm) £/ Animal ( % ) Tlant Animal Plant Animal Plant And Animal
Grasshopper 23.0 4.6 61% 39% 58.0 ppm(k) 12.0 ppm (k) 35.3 ppm 4.7 ppm 40.0 ppm
sparrow Grasshoppers Seeds:
(Adult) Caterpillars Bristlegrass
t Ants Ragweed
etc. Knotweed
etc.
Carolina 22.2 4.4 99% 1% 58.0 ppm(k) 12.0 ppm(k) 57.4 ppm .1 ppm 57.5 ppm
wren Ants Seeds
(Adult) Flies Poison Ivy
Milipedes Pine
FOOTNOTES:
I/ Refer to Table 5 (Footnote 6) for an explanation of how the "calculated LCso's" were
obtained.
2/ Restricted Use classification criteria [40 CFR 162.11(c)(2)(iii)(B)].
3/ This information is taken from Martin, Alexander C. et a.l.f American Wildlife and Plants:
A Guide Inc., NY 1951.
4/ Based upon a 1.0 Ib active ingredient per acre (after soil incorporation) application to
expected food times using the following references:
a. Hoerger, F.D. ; Kenaga, E.E. Pesticide Residues on Plants. Correlation of Represen-
tative Data in the Environment. EnvArpnmenta 1 Quality^ Academic Press, New York, I_:
9-28, 1972.
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TABLE 6 (continued)
DIETARY CONTAMINATION AND TOTAL ESTIMATED FENAMIPHOS RESIDUES FOR EIGHT SPECIES OP NON-TARGET BIRDS
FOOTNOTES (Continued)
b. Kenagar E.E. Factors to be Considered in the Evaluation of the Toxicity of Pesticides to Bird and
Safety, Academic Press, NY, II: 166-181, 1973.
5/ Residue values adjusted to reflect percentage of animal/plant matter consumed. Examples:
a. Bobwhite Quail, Adults: b. Robin, Adult:
58.0 ppm x 0.27 (27%) «= 15.7 ppm 58.0 ppm x 0.40 (40%) = 23.2 ppm
12.0 ppm x 0.73 (73%) = 8.8 ppm 12.0 ppm x 0.60 (60%) = 7.2 ppm
6/ Reflects total residues expected in the diet: animal or plant alone or a total of animal and plant food
tines. Examples:
a. Robin, Adult: b. Mourning Dove, Adult:
23.2 + 7.2 « 30.4 ppm total for 12.0 ppm total expected in food items
animal and plant foods consumed (i.e., 1.00 (100%) x 12.0 ppm
= 12 ppm).
I/ (k) refers to maximum expected residues as per (4)(a), and (b) above.
B/ This is the maximum expected residue value for daily pesticide burden occurring from animal items.
9/ Daily pesticide burden occurring from ingested plant item?.
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Aquatic Hazard As.sessment. Because fenamiphos has
been characterized as very highly toxic to both cold
and warm water fish species, the Agency is particularly
concerned about the direct and indirect hazard that
this material may pose to aquatic environments.
The terrestrial food crop uses where aquatic
contamination is of primary concern are citrus,
nonbearing fruit trees and tobacco where drift,
runoff, and soil erosion of fenamiphos to lakes,
streams, ponds, and other bodies of water and wetlands
may occur. Obviously, the greatest potential for
hazard to fish would occur if, during treatment,
fenamiphos was directly applied to aquatic environments.
There are no registered uses for direct application
to water. However, such a circumstance could easily
occur if fenamiphos were aerially applied as a broadcast
soil treatment to fields where citrus, orchards, and
tobacco are to be planted; and where interconnected
waterways such as ditches, canals, creeks, streams,
and ponds are used for irrigational purposes. Ground
application would, for the most part, preclude any
direct application to wetland areas. However,
contamination could still occur from runoff.
Table 7 shows the estimated environmental concen-
trations of fenamiphos that could occur from direct
application to water at the maximum accepted rate
for three sites: citrus, fruit trees,"and tobacco.
Comparing the 96-hour bluegill sunfish LCso of 9.6
ppb, the estimated exposures suggest that direct
application of fenamiphos to lentic (sluggish) bodies
of water (worst case situation) will result in
residues in six inches of water that exceed l/10th
the LC^Q by 1,250 times (1200ppb/0.96 ppb) and will
most likely cause significant adverse effects.
One-tenth the LCso for aquatic organisms is the
criteria for restricted use classification as specified
in 40 CFR 162.11(c)(2)(iii)(C).
Table 8 shows the estimated environmental concentrations
of fenamiphos in runoff for both lentic (sluggish) and
lotic (actively moving) environments. EECs for
fenamiphos from runoff have been determined for both
lentic and lotic environments using the EXAMS II
(Exposure Analysis Modeling System). To determine
these EECs, the amount of runoff from a 10 hectare
tobacco field (i.e., unit of runoff/acre from SWRRB
x 10) was foaded into a Georgia pond (lentic)/ stream
(lotic) scenario to simulate the fate of fenamiphos
in a Georgia aquatic system. The Georgia pond-stream
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36
scenario consists of a one hectare farm pond, 2
meters-deep, that is surrounded by a 10 hectare
drainage basin and drains into two streams. One is
short (100 meters-long, 3 meters-wide and .05 meter
-deep), and one is long 300 meters-long, 3 meters-
wide, and .05 meter-deepr). EECs were based on an
application rate of 20 Ibs ai/A, soil incorporated
(2-4") and/or watered-in (95% incorporation assumed).
Comparison of fish toxicity data and the EEC's in
Table 8 suggest that nontarget fish indigenous to
small ponds and streams will be exposed to fenamiphos
residues in runoff (worse case situation) that are
above the LCso value (9.6 ppb) and restricted use
classification criteria (1/10 LC50 « .96 ppb) and
will most likely cause significant adverse effects.
In order to accurately determine the potential
exposure and toxicity of fenamiphos to aquatic
environments the Agency is requiring the aquatic
toxicity tests listed in Appendix I/ Table A of
this standard which include simulated and actual
field testing of aquatic organisms.
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37
TABLE 7
ESTIMATED ENVIRONMENTAL CONCENTRATIONS3 (EBCs) (PPM) OF FENAMIPHOS IN WATER
CONTAMINATED BY DIRECT APPLICATION
ApplicatiQn Water
Rate Depth >Coprantarajbij3nb
Crop (IbTaT/A) (in.) (ppnff""""'
Fruit trees (bearing) 20.0 0.5 14.7
Citrus (bearing) 20.0 0.5 14.7
Tobacco 6.0 0.5 4.4
Fruit trees (bearing) 20.0 1.0 7.4
Citrus (bearing) 20.0 1.0 7.4
Tobacco 6.0 1-0 2.2
Fruit trees (bearing) 20.0 6.0 1.2
Citrus (bearing) 20.0 6.0 1.2
Tobacco 6.0 6.0 0.4
a/ Estimates are based upon the maximum application rate, aerially applied as a
broadcast, preplant soil treatment.
b/ The concentration values shown are based upon a nomograph developed by
DeWitt at the Patuxent Wildlife Research Center at Patuxent, Maryland.
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, TABLE 8
ESTIMATED ENVIRONMENTAL CONCENTRATIONS (EECs) (PPB)a OF FENAMIPHOS
IN LENTIC AND LOTIC SCENARIOS FROM RUNOFF
Concentration
Soil Incorporation (2-4*)
Lentic Lotic
Pond Stream I_ Streani II
(ppb) fppbf ~ (ppb) '
a) 1% runoff 14.55 10.45 7.25
b) 5% runoff 72.8 52.27 36.25
WateredHLn
a) 1% runoff 112.0 80.42 55.78 CO
i
b) 5% runoff 560.0 I 402.0 279.0
1
a/ EECs were based on an application rate of 20 Ibs ai/A, soil incorporated
(2-4") and/or watered-in (95% incorporation assumed).
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39
Endangered Species Hazard Assessment.
1). EPA has consulted with the Office of Endangered
Species of the Fish and Wildlife Service concerning
the potential adverse effects on endangered and
threatened species for the cotton and soybean uses
of fenamiphos. OES issued biological opinions which
found that these uses jeopardize the survival of the
following species.
Cotton Cluste.r Soybean Cluster
Alabama cavefish Attwater's greater
Attwater's greater prairie chicken
prairie chicken Kern primrose sphinx
Bayou darter moth I/
Comanche springs Mussels
pupfish Scioto madtorn
Foutain darter Slackwater darter
Gila topminnow
Houston toad
Leopard darter
Mussels
Pecos gambusia
San Marcos gambusia
Slackwater darter
I/ California label only. Preplant soil treatment
may result in minimal exposure to this insect.
The Agency has determined that the Endangered Species
labeling contained in Section IV.D. of this
Registration Standard is necessary to prevent
unreasonable adverse effects to endangered or
threatened species.
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40
Reentry Con^i operations. Toxicity and exposure criteria
are set forth in 40 CFR.158. If a chemical meets the
specified criteria, reentry data are required.
Fenamiphos meets the toxicity criteria in that the technical
grade of the active ingredient has an acute dermal toxicity
of less than 200 mg/kg body weight, an acute inhalation
toxicity of less than 200 mg/ra3 for a one-hour exposure,
and an acute oral toxicity of less than 50 mg/kg body weight.
Fenamiphos also meets the exposure criteria in that it is
registered for use on crops where current agricultural
practices include human tasks which involve substantial
exposure to residues of the pesticide. An interim 48-hour
reentry interval is being imposed until adequate data
have been submitted and evaluated.
Product Chejnistry,. The Agency has evaluated data which
Tdentify the ingredients, materials, and manufacturing
process and discuss the physical and chemical properties of
fenamiphos. Additional product chemistry data as identified
in Appendix I, Tables A and B, are being required.
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41
D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of
fenamiphos in a variety of raw agricultural commodities, in
meat, fat and meat byproducts (40 CFR 180.349 [a] and [b]),
and in processed food (21 CFR 193.463) and feed (21 CFR
561.232).
EPA has evaluated the residue and toxicology data
supporting tolerances, and has made the following.regulatory
determinations:
°Whether the current tolerances and food additive regu-
lations are sufficient to cover the actual residues resulting
from use (including uses registered under FIFRA sec. 24(c)
and intrastate uses).
"Whether group tolerances can be established in accor-
dance with 40 CFR 180.34(f).
"Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are necessary.
•Whether the tolerances are expressed accurately and in
/ current terminology.
The regulatory determinations resulting from EPA's
review are set out in Section IV.A. of this document,
Regulatory Positions and Rationales.
1. Residue Data.
The residue data reviewed in support of these tolerances
include the following:
a- Data on tjhte nature of the residues in both plants
and aKimaIs, ^including identification of major roetabolites
andi ,degradates of f e_r>amip_hos). The metabolites of
fenamiphos are fenamiphos sulfoxide (FSO), fenamiphos
sulfone (FSC>2)r des-isopropyl fenamiphos (DIP), des-
isopropyl fenamiphos sulfoxide (DIFSO), fenamiphos
sulfoxide phenol (FSOP), fenamiphos sulfone phenol
(FSC>2P)» and fenaraiphos phenol (FP). Tolerances for
residues of fenamiphos in food items derived from plants
are currently expressed in terms of the combined residues
of fenamiphos-and its cholinesterase-inhibiting metabolites,
fenamiphos sulfoxide and fenamiphos sulfone. Tolerances
for residues of fenamiphos in food items derived from
animals are expressed in terms of the combined residues
of fenamiphos and its sulfoxide and sulfone as well as
des-isopropyl fenamiphos, des-isopropyl fenamiphos
sulfoxide and des-isopropyl fenamiphos sulfone.
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42
b. Radiolabeled studies on .the uptake, translocation
and metabolAsm Qf_ f_enamiphos in jplants show that
metabolic pathways involve oxidation of fenamiphos to
fenamiphos sulfoxide and/or fenamiphos sulfone and
subsequent hydrolysis to fenamiphos sulfoxide phenol
and fenamiphos sulfone phenol and formation of
glucoside and other conjugates. Although the phenols
are present as significant portions of the total
residue in plants, they are not currently included in
the tolerance expression because the Agency has no
concern regarding their toxicological significance at
this time.
c. Radiolabeled studies on the metabolism _amj. translo-
_
cation of fenamiphos in cows, rats, chickens, smA jswirie
shdw "that the meta&olism off fenamiphos Tn poultry
(including eggs) and ruminants (including milk) is not
adequately understood. In addition to the known plant
metabolites, des-isopropyl fenamiphos and des-isopropyl
fenamiphos sulfoxide have been found in ruminant tissues
and milk after dosing with fenamiphos sulfoxide.
There are deficiencies in available hen, ruminant,
and swine metabolism studies. Therefore, metabolism
studies utilizing ruminants and poultry in which ring-
labeled [l^c] fenamiphos is administered are being
required. In addition tissue samples from these studies
must be analyzed using current enforcement methods.
Should the metabolism of fenamiphos in ruminants or
poultry be found to differ significantly from that in
rats, additional swine metabolism studies may be required.
d. Analytical methodology. ,f or jdeterminlng the levels o_f
residues .of ^fenamiphos in plants. and animals. Residues
of fVnamipnos "sulfoxicfe" ana fenamiphos sulYone in or on
plant and animal commodities and of des-isopropyl
fenamiphos, des-isopropyl fenamiphos sulfoxide, and
des-isopropyl fenamiphos sulfone in or on animal
commodities must be subjected to analysis by multiresidue
protocols available from the National Technical
Information Service (NTIS). Additional methods,
validation data and residue data may be required if
metabolism studies indicate additional metabolites of
toxicological concern in animals.
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43
e* g^tQirage stability data. Fenamiphos, fenamiphos
sulfoxideT and fVnaraiphos sulfone are stable in frozen
plant commodities stored up to 1,086 days. Additional
storage stability data for residues in muscle, fat,
liver, kidney, milk, and eggs are necessary because
the available data indicate poor stability in animal
tissues and products after 64-75 days of frozen storage.
Data on storage intervals and conditions of storage of
previously submitted samples must be submitted and
accompanied by fortification recovery data for all
animal commodity samples and any plant samples stored
longer than 3 years.
It should be noted that the nature of the residue
in animals has not been adequately described. If
the requested metabolism data indicate the presence
of additional residues of toxicological concern in
animal commodities, data depicting the stability of
such residues in storage will be required.
f . Data on^ ^the magnitude _am3 levels pf res. idues of
fenamiphos in _i_ndiyi_dual raw agricultural commodities,,
animal ^products, .and. I>rQcessed food and feed items.
Sufficient data are aval Table to ascertain the
adequacy of the established tolerances for residues
of fenamiphos in or on the following raw agricultural
and processed commodities: brussels sprouts, cabbage,
soybeans, grapefruit, lemons, limes, oranges, tangerines,
dried citrus pulp, citrus oil, citrus molasses, apples,
dried apple pomace, cherries, peaches, grapes, raisins,
raisin waste, raspberries, asparagus, cottonseed, okra,
peanuts, and pineapples.
Insufficient data are available to ascertain the
adequacy of the established feed additive tolerances
for residues in dried grape pomace and pineapple
bran. Also, processing studies are required for the
following commodities: soybeans, grapes (juice and
dried pomace only), cocoa beans, cottonseed, peanuts,
meat, and milk,
Sufficient documentation is not available to
ascertain the adequacy of the established tolerances
for fenamiphos residues in or on garlic, bananas, and
cocoa beans imported into the U.S. Also, additional
residue data are needed for cocoa beans.
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2- Toxicology Data.
The toxicology data considered in support of the tolerances
include:
2-year dog feeding study; NOEL = .025 mg/kg of
animal body weight/day
The Acceptable Daily Intake (ADI) and Maximum Permissible
Intake (MPI) are two ways of expressing the amount of a
substance that the Agency believes, on the basis of the
results of data from animal studies and the application of
"safety" or "uncertainty" factors, may safely be ingested by
humans without risk of non-oncogenic adverse health effects.
The ADI is expressed in terms of milligrams (mg) of the
substance per kilogram (kg) of body weight per day (mg/kg/day).
The MPI, a related figure, is obtained by assuming a human
body weight of 60 kg, and is expressed in terms of mg of
substance per day (mg/day). The Agency has calculated a
Provisional ADI (PADI) of 0.00025 mg/kg/day for fenamiphos
due to the lack of an adequate teratology study. The MPI
for fenamiphos is 0.015 mg/day.
The PADI for fenamiphos currently is based on the results
/ from a 2-year dog feeding study, from which the Agency
concluded that the no-observed-effect-level (NOEL) was seen
at 1 ppm of the substance in the animals' diet, or 0.025
mg/kg of ajiimal body weight/day. Cholinesterase inhibition
was seen at all other dose levels, 2, 5, and 10 ppm. The
PADI was derived by use of a safety factor of 100 to account
for the lack of an adequate teratology study. The NOEL
from the dog study, 0.025 mg/kg/day divided by this 100-fold
factor, yields a human PADI of 0.00025 mg/kg/day. The MPI
for a 60-kg human is 0.015 mg/day.
The theoretical maximum residue contribution (TMRC) is
the theoretical maximum amount of residue of a pesticide
that might be present in the human diet, based on assumptions
the Agency makes about the average human daily intake of
foods containing residues at the level of the established
tolerances. The TMRC for the U.S. population average based
on published tolerances only is 0.0020 mg/kg/day which occupies
812% of the PADI. Utilization of anticipated residues and
percent of crop treated lowers this estimate to 0.00011 mg/kg/
day which corresponds to 42% of the PADI.
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45
Dietary exposures for 22 subgroups of the U.S. population
have also been estimated. The two highest highest calculated
exposures (published tolerances only) were non-nursing infants
with a THRC of 0.0067 rag/kg/day which occupies 2684% of the
PADI, and children 1 to 6 years of age with a TMRC of 0.0056
rag/kg/day which occupies 2230% of the PADI. Utilization of
anticipated residues and percent of crop treated lowers
these estimates to 0.0003 mg/kg/day, which occupies 112% of
the PADI, and 0.0002 mg/kg/day, which occupies 96% of the
PADI, respectively. Since meat and milk contribute
significantly to the TMRC, it is possible that the required
processing studies that will demonstrate the effect of cooking
meat and the pasteurization of milk or the production of
infant formula on residue levels of fenamiphos and its
metabolites, may lower the estimated dietary exposure for
these two subgroups in particular in addition to the overall
U.S. population.
Since the PADI is a provisional value, it is possible that
resolution of the teratology data gap may allow for a lower
uncertainty factor which will result in a higher ADI and
consequently a lower percentage of the ADI occupied by the
TMRC.
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46
3. Tolerances issued.
Tolerances have been established for residues of
fenamiphos in a variety of raw agricultural commodities
(40 CFR 180.349 [a]), in meat, fat and meat byproducts
(40 CFR 180.349 [b]), and in processed food (21 CFR 193.463)
and feed (21 CFR 561.232).
There are no Mexican or Canadian tolerances for fenamiphos.
To permit compatibility with Codex Maximum Residue Limits
(MRLs), the Agency is; (1) reducing the tolerances for residues
in or on brussels sprouts and cabbage from 0.1 to 0.05 ppm;
(2) establishing a crop group tolerance of 0.5 ppm for residues
in or on citrus fruit (with a concomitant revocation of the
0.6 ppm tolerances for residues in or on oranges* grapefruit,
lemons, limes, and tangerines); and (3) increasing tolerances
for residues in or on peanuts from 0.02 to 0.05 ppm.
In addition, the Agency is making the following
determinations:
(1). "grape pomace" in the 21 CFR should be changed to
"grape pomace dried", the appropriate definition for
this commodity.
(2). a tolerance proposal of 0.1 ppm or feeding and
grazing restrictions must be proposed for cotton forage.
(3). Special Local Need registrations IFIFRA Sec. 24(c)]
permitting the use of fenamiphos as broadcast soil
applications to nonbearing nut trees and pears must be
canceled or supported by residue data to determine the
appropriateness of the current nonfood classification.
(4). For tobacco, data depicting pyrolysis products
derived from the active ingredient must be submitted.
Tolerances are pending for residues in or on carrots,
sugar beet roots, dried pulp and tops, sweet potatoes,
tomatoes, and dried tomato pulp, and cucurbit vegetables.
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47
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on the review and evaluation of all available data on
fenamiphos the Agency has made the following determinations.
Where it is the Agency's position that label revisions
are needed in order for a product to remain in compliance
with FIFRA, specific language is set forth in Section D
of this chapter.
1. The Agency will not, at this time, initiate a Special
Review [40 CFR Part 154] of fenamiphos. After review and
evaluation of the required studies for fish and wildlife the
Agency will reconsider the possibility of a Special Review.
Acceptable protocols for conducting the avian, mammalian, and
fish field studies must be submitted within six months of
the issuance of the standard and be accepted by the Agency
before the initiation of field work. Annual progress reports
must also be submitted for the duration of the study. The
application rates used in these studies must be the lowest
possible rates that are still efficacious as indicated by
the required efficacy data (refer to Regulatory Position 3).
Rationale; Fenamiphos is very highly toxic to birds
/I. 6 rag/kg) and mammals (LDso 2.7 mg/kg) as well as to cold
(LC5Q 72.1 ppb) and warm water (LCso 9.6 ppb) fish species.
Estimated environmental concentrations (EECs) of the granular
formulation of fenamiphos exceed the acute oral LDso for the
most sensitive avian species tested, the bobwhite quail, and
the estimated LDso values for 5 other avian species. EECs
also exceed the LDso for tne rat and the estimated LDso
values for two other mammalian species. EECs of the
emulsif iable concentrate formulation indicate that fenamiphos
residues exceed the calculated subacute dietary LCso for four
avian species.
Field studies using both granular and spray formulations of
fenamiphos according to label directions have shown some
avian and mammalian mortality. These studies also suggest
that soil incorporation and/or irrigation immediately following
application reduces hazards. However, because of design
deficiencies these studies do not meet guideline requirements;
therefore, a terrestrial field study is being required to
determine if the hazards indicated by lab and field studies
are below levels of concern for mammalian and avian species
under actual use conditions.
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48
Estimated environmental concentrations for water contaminated
by aerial application to crops and for runoff exceed the
LC5Q values for bluegill sunfish, and therefore, would cause
significant adverse effects. Thus, the following tests
are being required to fully assess the potential exposure and
toxicity of fenamiphos to aquatic environments: freshwater
fish toxicity (on EPs), freshwater invertebrate acute toxicity
(using the technical and EPs), estuarine and marine acute
toxicity, fish early life stage testing, fish life cycle,
aquatic invertebrate life cycle, aquatic organism accumulation,
and simulated and actual field testing of aquatic organisms.
2. The Agency is requiring restricted use classification
for all fenamiphos formulated products.
Rationale; Fenamiphos exceeds the restricted use criteria
set forth in 40 CFR 162.11(c)(2)(ii) and (iii). Use of
fenamiphos formulations has resulted in mortality to birds
and mammals. Fenaraiphos is acutely toxic to laboratory
animals, Toxicity Category I, by the oral, dermal, and
inhalation routes of exposure. It is also very highly toxic
to birds as well as cold and warm water fish species. Use
of fenamiphos exceeds the restricted use criteria for fish and
wildlife; calculated residues exceed 1/5 the acute oral LD5Q
for mammals, 1/5 the subacute dietary LCso for avian species, and
1/10 the acute LCso for aquatic organisms. In addition, use
of fenamiphos has resulted in mortality to birds and mammals.
/Accordingly, the Agency has determined that the risks to
humans, fish, and wildlife, associated with the unrestricted
use of fenamiphos products, constitute unreasonable adverse
effects. Restricting the use of all fenamiphos products will
reduce exposure and the potential for acute toxicity. Field
studies on birds, mammals, and aquatic organisms, are being
required to determine actual exposure levels and potential
hazard.
3. The Agency is requiring that efficacy data be submitted
to support all currently registered application rates.
Rationale; EECs based on the maximum application rate exceed
LD5Q values for birds and mammals and the LCso value for
fish. Therefore, the Agency is requiring that efficacy data
be submitted within six months of the issuance of the standard
to support the current application rates. If such data
indicate that rates could be lowered with minimal decrease in
efficacy the Agency will require that all labels be revised
to the lowest possible rates that are still efficacious.
These labeling changes would reduce environmental concentra-
tions of the pesticide while substantive data on the effects
on fish and wildlife are being collected.
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49
4. The Agency is requiring that all labels be revised as
follows:
1). Directions for broadcast spray will be deleted
for sites which currently have directions for both
band and broadcast spray.
2). All labels will prohibit the use of mist sprayers
and will direct applicators to use only coarse sprays
directed at the soil to reduce the possibility of
spray drift.
3). All labels will specifically prohibit aerial
application.
Rationale; As stated above, EECs based on the maximum
application rate exceed LDso values for mammalian and
avian species and the LCso value for aquatic organisms.
The above labeling changes would reduce environmental concen-
trations of the pesticide while substantive data on the
effects of fenamiphos on fish and wildlife are being collected.
5. The Agency is requiring endangered species labeling
on fenamiphos EPs registered for use on cotton and soybeans
in accordance with Pesticide Registration (PR) Notice 87-5
(issued Hay 1, 1987). (Refer to Chapter IV, Section D of
/this document, for exact language.)
Rationale; Fenamiphos was reviewed for endangered species
implications. In order to protect endangered species from
harm, endangered species labeling is required. (Refer to
Chapter III, Section C of this document, for a list of
the species).
6. The Agency is unable to fully assess the environmental
fate of fenamiphos and is requiring the following studies:
photodegradation (air), anaerobic and aerobic soil metabolism,
leaching and adsorption/desorption, volatility (lab), soil
dissipation, rotational crops (confined and field), fish
accumulation, and spray drift studies.
Rationale; Except for a hydrolysis study and a photodegradation
study in water, all the available environmental fate data do
not meet the guideline standards for acceptable testing.
These data are normally required under 40 CPR Part 158.130
and are necessary to assess the environmental fate and
transport and potential exposure to fenamiphos.
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50
7. The Agency will evaluate the potential of fenamiphos
to contaminate ground water after it has received and
evaluated additional required environmental fate data.
Rationale; The potential for fenamiphos to reach ground
water cannot be determined at this time. Some existing
studies, though deficient in some respects, show it does
leach to some degree. Additional data are required to fully
assess the potential for fenamiphos to reach ground water.
8. The Agency is unable to completely define the metabolism
of fenamiphos and to fully assess its teratogenic potential;
therefore, the Agency is requiring the submission of a rat
metabolism study and teratology studies in two species.
Ratiojiale; General metabolism and teratology studies
are normally required by 40 CFR Part 158.135 for products
with fenamiphos' use patterns. There are currently no
metabolism studies or rat teratology studies available and
the available rabbit teratology study does not meet guideline
requirements.
9. Available residue chemistry and toxicology data are
insufficient to permit the Agency to conduct a full tolerance
reassessment.
Rationale'; Data gaps exist for animal metabolism, storage
stability* analytical methods, and magnitude of residues in
some raw agricultural commodities and processed food and
feed items. Thus, upon receipt of the data required in
Table A, the Agency's conclusions with regard to the adequacy
of established tolerances are subject to change.
10. The Agency is not requiring additional residue data
on the following raw agricultural commodities or proceseed
feed items; brussels sprouts, cabbage, soybeans, grapefruit,
lemons, >imes, oranges, tangerines, dried citrus pulp, citrus
oil, citrus molasses, apples, dried apple pomace, cherries,
peaches, grapes, raisins, raisin waste, raspberries,
asparagus, cottonseed, okra, peanuts, and pineapples.
Rationale; The Agency has determined that the available
residue data adequately support the established tolerances
for these raw agricultural commodities.
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11. The Agency is requiring English language translation
of product labels for garlici bananas, and cocoa beans
imported into the U.S.
Rationales Insufficient documentation is available to
ascertain the adequacy of the established tolerances for
fenamiphos residues in or on garlic, bananas, and cocoa beans
imported into the U.S. The Agency will be able to determine
from current English translation labels if overseas application
rates result in residues that exceed established tolerances.
12. The Agency is requiring data to determine the pyrolysis
products of fenamiphos in tobacco products and the level of
residues in tobacco smoke.
Rationales Residue data previously submitted for residues of
fenamiphos in or on tobacco indicate that the combined
residues of fenamiphos and its sulfoxide and sulfone in or
on cured tobacco exceed 0.1 ppm following application at the
registered rate. Therefore, the Agency is requiring these
data to. assess the human exposure to fenamiphos residues in
tobacco products.
13. The Agency is; (1) reducing tolerances for residues in
or on Brussels sprouts and cabbage from 0.1 to 0.05 ppm,
(2) establishing a crop group tolerance of 0.5 ppm for
residues in or on citrus fruit (with a concomitant revocation
of the 0.6 ppm tolerance for residues in or on oranges,
grapefruit, lemons, limes), and (3) increasing tolerances for
residues in or on peanuts from .02 to .05 ppm.
Rationale: These actions will permit compatibility with
CODEX MRLs.
14.. The Agency is requiring the submission of residue data
supporting broadcast soil application of fenamiphos to
nonbearing nut trees and pears (FIFRA Section 24(c)).
Rationale; The data are required to assess the current
non-food classification of this use. Alternatively, the
registrant may cancel this use.
15. The Agency is requiring a tolerance proposal of 0.1 ppm
for cotton forage.
Rationale; Based on available data the Agency has
(Jetermined that a tolerance of 0.1 ppm would be appropriate.
Alternatively, the registrant may amend use directions
to include grazing and feeding restrictions for cotton forage.
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16. The Agency is requiring reentry data for fenamiphos.
In order to maintain compliance with FIFRA an interim
48-hour reentry interval requirement for fenamiphos must
be placed on the labels of all fenamiphos end-use products
until the required data are submitted and evaluated and
any change in this interim reentry interval is announced.
Rationale; Fenamiphos meets both the acute toxicity and
exposure criteria specified in 40 CFR 158.140 for reentry
data. Until these data are received and evaluated an
interim 48-hour reentry interval will serve to reduce
exposure of field workers to this chemical.
17. While data gaps are being filledf currently registered
manufacturing use products (MPs) and end use products (EPs)
containing fenamiphos as the sole active ingredient may be
sold, distributed, formulated and used, subject to the terms
and conditions specified in this Standard. Registrants must
provide or agree to develop additional data, as specified in
the Data Appendices, in order to maintain existing regis-
trations.
Rationale: Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or
are inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory
changes are necessary.
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B. CRITERIA POR REGISTRATION
To be registered or reregistered under this Standard,
products must contain fenamlphos as the sole active
Ingredient, bear required labeling, and conform to the product
composition, acute toxicity limits, and use pattern requirements
listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain fenamlphos
as the sole active ingredient. Each MP formulation proposed
for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert Ingredients which are
present in products, as well as impurities found at greater
than 0.1J.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing fenamlphos
provided that the product labeling bears appropriate precaution-
ary statements for the acute toxicity category in which each
product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The EPA Index to
Pesticide Chemicals lists all registered uses, as well as
approved maximum application rates and frequencies.
-Terrestrial, non-domestic, food uses on;
apples, asparagus, brussels sprouts, cabbage,
cherries, citrus citrus, cotton, grapes, okra,
peach, peanuts, pineapple, raspberry, soybeans
-Terrestrial, non-domestic, non-food uses on;
non-bearing orchards, nursery stock (forest
trees and ornamentals), tobacco
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D. LABELING
Products subject to the requirements of this Registration
Standard may not be released for shipment after
August 1, 1988, unless the product bears amended labeling
which complies with the requirements of this Standard.
[Exception: Endangered species labeling which must be on
products released for shipment after February 1, 1988 and on
all products after February 1, 1989 as specified in Pesticide
Registration (PR) Notice 87-5.] After reviewing data to be
submitted under this Standard, the Agency may impose additional
label requirements.
Products subject to the requirements of this Registration
Standard may not be distributed, sold, offered for sale,
held for sale, shipped, delivered for shipment, or received
and (having been so received) delivered or offered to be
delivered by any person after August 1, 1988, unless the
product bears amended labeling which complies
with the requirements of this standard.
1. Manufacturing-Use Product Statements
a. Ingredients Statement
/ The ingredient statement for MPs must list the active
ingredient as:
0-ethyl-0-(3-methyl-*l-methyl-thiophenyl)isopropyl-
phosphoramidate
b. Use Pattern Statements
All manufacturing-use products roust state that they
are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify sites,
which are listed In Use Patterns, Section C.3. However,
no use may be included on the label where the registrant
fails to agree to comply with the data requirements in
TABLE A for that use pattern.
c. Precautionary Statements
This pesticide is toxic to fish and wildlife. Do
not discharge effluent containing this product
Into lakes, streams, ponds, estuaries, oceans, or
public water unless this product Is specifically
identified and addressed in the NPDES permit.
Do not discharge effluent containing this product
to sewer systems without previously notifying
the sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office
of the EPA.
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2. End-Use .Product Statements
a. Ingredients Statement
The ingredient statement for EPs must list the
active ingredient as:
O-ethyl-0-(3-roethyl-4-methyl-thiophenyl)isopropyl-
phosphoramidate
b. Precautic?nary St.at erne n t s
RESTRICTED USE PESTICIDE
For sale to and use only by a certified applicator
for uses authorized by his certification, or by
persons under his direct supervision.
Do not reenter treated area for 48 hours unless
appropriate protective clothing is worn.
USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING
AND EQUIPMENT DURING MIXING/LOADING, APPLICATION,
REPAIR AND CLEANING OF MIXING, LOADING AND APPLICATION
EQUIPMENT, DISPOSAL OF THE PESTICIDE, AND EARLY
REENTRY INTO TREATED AREAS: protective suit of one or
two pieces covering all parts of the body except
head, hand, and feet; chemical resistant gloves; _
chemical-resistant shoes (or chemical-resistant shoe
covers or chemical-resistant boots); and a NIOSH- or
MSHA- approved respirator. In addition, mixer/loaders
must wear a chemical-resistant apron. During equipment
repair and cleaning, the respirator need not be
worn. During early reentry after sprays have dried
or dust has settled and vapors have dispersed, the
respirator need not be worn.
IF MIXING/LOADING IS PERFORMED USING A CLOSED SYSTEM,
THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY BE
WORN AS AN ALTERNATIVE: long-sleeved shirt and long-
legged pants; chemical-resistant gloves; chemical-
resistant apron; shoes and socks. Goggles or face
shield must be worn if the system is under pressure.
IF APPLICATION IS PERFORMED USING AN ENCLOSED CAB,
THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY
BE WORN AS AN ALTERNATIVE: long-sleeved shirt and
long-legged pants; shoes, and socks. Chemical-
resistant gloves must be available in the cab and must
be worn when exiting. This clothing is inadequate
to protect you during equipment repair or cleaning,
reentry, or pesticide disposal work.
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IMPORTANT! If pesticide comes In contact with skin,
wash off with soap and water. Always wash hands,
face, and arms with soap and water before smoking,
eating, drinking, or toileting.
AFTER WORK: Before removing gloves, wash them with
soap and water. Take off all work clothes and shoes.
Shower using soap and water. Wear clean 'clothes.
Do not reuse contaminated clothing. Personal
clothing worn during work must be laundered
separately from household articles. Store protective
clothing separately from personal clothing. Clean
or launder protective clothing after each use.
Respirators must be cleaned and filters replaced
according to instructions included with the
respirator. Protective clothing and equipment
that becomes heavily contaminated or drenched must
be destroyed according to state and local
regulations. HEAVILY CONTAMINATED OR DRENCHED
CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED.
0 Formulations other than granular:
This pesticide is toxic to fish and wildlife.
Drift and runoff from treated areas may be
hazardous to aquatic organisms in neighboring
areas. Do not apply directly to water or
wetlands (swamps, bog, marshes, and potholes).
Do not contaminate water by cleaning of
equipment or disposal of wastes.
Do not use mist sprayers. Use only coarse sprays
directed at soil to eliminate spray drift.
Aerial application of this product is prohibited.
0 Granular formulations:
This pesticide is toxic to fish and wildlife.
Cover, Incorporate, or pick up spilled granules
at row ends or turn areas. Runoff from treated
areas may be hazardous to aquatic organisms in
neighboring areas. Do not apply directly to
water or wetlands (swamps, bogs, marshes, and
potholes). Do not contaminate water by cleaning
of equipment or disposal of wastes.
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The following Information on endangered species must appear
on the labeling of all EPs registered for use on soybeans
and cotton. Statement "A" is to be used only on product
labels if Statement "B" is not on the product label, but
instead, in the product labeling. [EXCEPTIONS: Products
used directly on humans or pets; in, on or around any
structure, vehicle, article, surface, or area associated
with the household, including but not limited to areas such
as out-buildings, non-commercial greenhouses, pleasure
boats, and recreational vehicles, or in any preschool or
day care facility, and which are labled only for such
uses are exempt from the labeling requirements to protect
endangered species].
A. "Refer to product labeling for use restrictions to
protect ENDANGERED SPECIES."
B. "ENDANGERED SPECIES RESTRICTIONS
The following restrictions apply to use of this product
after February 1, 1988.
Before using this pesticide on cotton and soybeans in
the counties listed below, you must obtain the
PESTICIDE USE BULLETIN FOR PROTECTION OF ENDANGERED SPECIES
for the county in which the product is to be used. The
bulletin is available from your County Extension Agent,
State Fish and Game Office or your pesticide dealer.
*R manne
.._-_-.. . ... _.
PESTICIDE USE BULLETIN FOR PROTECTION OF ENDANGERED SPECIES
is a violation of Federal laws."
ALABAMA
COLBERT, GREENE, JACKSON, LAMAR LAUDERDALE, LIMESTONE,
MADISON, MARSHAL, MORGAN, PICKENS, AND SUMTER
ARIZONA
GRAHAM, MARICOPA, MOHAVE,.PIMA, FINAL, AND SANTA CRUZ
ARKANSAS
BENTON, CLAY, CLARK, CROSS, LAWRENCE, LEE, POINSETTE,
POLK, RANDOLPH, SHARP, AND ST. FRANCIS
CALIFORNIA
COLUSA, IMPERIAL, INYO, LOS ANGELES, MERGE, MODOC,
ORANGE, RIVERSIDE, SAN BERNARDINO, SAN DIEGO,
SANTA BARBARA, STANISLAUS, SUTTER, AND VENTURA
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FLORIDA
ALACHUA, BAKER, BRADFORD, BREVARD, BROWARD, CHARLOTTE,
CITRUS, CLAY, COLLIER, COLUMBIA, DADE, DE SOTO,
DIXIE, DUVAL, PLAGLER, GADSDEN, GILCHREST, GLADES,
HARDEE, HENDRY, HERNANDO, HIGHLANDS, HILLSBOROUGH,
INDIAN RIVER, JEFFERSON, LAFAYETTE, LAKE, LEE, LEON,
LEVY, MADISON, MANATEE, MARION, MARTIN, MONROE, NASSAU,
ORANGE, OKEECHOBEE, OSCEOLA, PALM BEACH, PASCO,
PINELLAS, POLK, PUTNAM, ST. JOHNS, ST. LUCIE, SARASOTA,
SEMINOLE, SUMTER, SUWANNE, TAYLOR, UNION, VOLUSIA, AND
WAKULIA
GEORGIA
BRANTLEY, BRYAN, BULLOCH, BURKE, CAMDEN, CANDLER,
CHARLTON, CHATHAM, EFFINGHAM, EMANUEL, EVANS,
GLASCOCK, GLYNN, JEFFERSON, JENKINS, JOHNSON,
LIBERTY, LONG, MCINTOSH, PIERCE, RICHMOND, SCREVEN,
WARE, WASHINGTON, AND WAYNE
KANSAS
CLARK, COMANCHE, MEADE, AND STAFFORD
KENTUCKY
/ BALLARD, BUTLER, EDMUNDSON, GREEN, HART, JACKSON,
LAUREL, LIVINGSTON, MARSHALL, MCCRACKEN, MCCREARY
PULASKI, ROCKCASTLE, TAYLOR, WARREN, AND WAYNE
MISSISSIPPI
CLAIBORNE, COPIAH, HINDS, ITAWAMBA, LOWNDES, MONROE,
AND NOXUBEE
MISSOURI
BARRY, BENTON, CAMDEN, CHRISTIAN, DALLAS, GREENE,
HICKORY, JASPER, LAWRENCE, MILLER, NEWTON, OSAGE,
POLK, ST. CLAIR, STONE, AND WEBSTER
MONTANA
GARFIELD, MCCONE, SHERIDAN, AND VALLEY
NEBRASKA
BOYD, BROWN, BUFFALO, BUTLER, CASS, CEDAR, COLFAX,
DAWSON, DODGE, DOUGLAS, HALL, HAMILTON, HOLT,
HOWARD, KEARNEY, KEYA PAHA, KNOX, MERRICK, NANCE,
PHELPS, PLATTE, POLK, ROCK, SARPY, AND SAUNDERS
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NEVADA
CLARK
NEW MEXICO
CRAVES, DEBACA, AND EDDY
NORTH CAROLINA
EDGECOMBE, NASH, AND PITT
NORTH DAKOTA
BANSON, BOTTINEAU, BURKE, BURLEIGH, DIVIDE, DUNN, EDDY,
EMMONS, POSTER, KIDDER, LOGAN, MCHENRY, MCINTOSH,
MCKENZIE, MCLEAN, MERCER, MORTON, MOUNTRAIL, NELSON,
OLIVER, PIERCE, RAMSEY, RANVILLE, ROLETTE, SHERIDAN,
SIOUX, STUTSMAN, TOWNER, WARD, WELLS, AND WILLIAMS
OHIO
PICKAWAY
OKLAHOMA
DELAWARE, MCCURTAIN, AND PUSHMATAHA
OREGON
/ LAKE
SOUTH CAROLINA
AIKEN, BARNWELL, BEAUFORT, BERKELY, CHARLESTON,
COLLETON, DORCHESTER, GEORGETOWN, HAMPTON, HORRY,
JASPER, AND MARION
SOUTH DAKOTA
CLAY, HAAKON, HUGHS, POTTER, STANLEY, SULLY, UNION,
WALWORTH, YANKTON, AND ZIEBACH
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2.
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions upon use, composition, or
packaging listed in Section IV.
2. If eligible for the forraulator's exemption3, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the forroulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
* Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential "Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the othrer registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other "registrant has .accepted
your offer. You requestthat EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4• You request awaiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recoramended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
P. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
-------
67
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and t
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
roust be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX. E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you .must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H . PR Notice 86-5 and Any Other Requirements Referenced or
included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DC I request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
-------
68
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F. and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
-------
69
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs)containing the subject
pesticide as sole active ingredient.
1. Within90days from receipt of this document, you
must submit tothe Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.^
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 if on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring. )
-------
70
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text.on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90. days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
-------
71
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement -(.EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with othe"r
a c t i ve ing re die n t's.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
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72
E. Addresses
The required information must be submitted to the following
address:
Lois Rossi (PM 21)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 N St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
-------
APPENDIX I
DATA TABLES
-------
73
TGUIDE-l
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CPR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI « Technical grade of the active ingredient
PAI « Pure active ingredient
PAIRA - Pure active ingredient, radio labeled
TEP « Typical end use formulation
MP « Manufacturing use product
EP - End use product
Any other test substances, such as metabolites, will be
specifically naiied in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column Indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CPR Part 158. The following
letter designations are used for the given use patterns:
A
B
C
D
E
P
G
H
I
Terrestrial, food
Terrestrial, non-food
Aquatic, food
Aquatic, non-food
Greenhouse, food
Greenhouse, non-food
Forestry
Domestic outdoor
Indoor
Any other designations will be defined in a footnote to the table,
-------
74
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152» Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also Indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
To" fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whetherthe datamust be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually Indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually Indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations '
will be explained In a footnote to the table.
7. Tlroeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted,-based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-In letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF FENAMIPHOS
Does EPA Must Additional Time Frame
Have Data to Data Be Submitted For
I/ Satisfy This Bibliographic Under FIFRA Section Data
Data Requirement Composition Requirement? 2/ Citation 2/ 3(c)(2)(B)? Submission
158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning Mater-
ials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
No
No
No
No
No
No
i
! No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
3/
Yes
I/
Yes
5/
Yes
y
Yes
Yes
y
Yes
yy
Yes
yy
Yes
y
Yes
6 months
6 months
12 months
•».
CJ
6 months
6 months
6 months
6 months
6 months
6 months
(continued, footnotes follow.)
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF FENAMIPHOS
Data Requirement
I/
Conposition
Does EPA
Have Data to
Satisfy This 2
Requirement? "
Bibliographic
( y
Citation
158.120 Product Chemistry, (continued)
63-8 - Solubility
63-9 - Vapor Pressure
i
63-10 - Dissociation Constant
63-11 - Octanol/Vfater Partition
Coefficient
•
63-12 - pH
63-13 - Stability
Other Requirements:
64-1 - Submit tal of samples
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
N/A
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7
V
Yes
Yes
V
Yes
6/9/
Yes
6/10/
Yes
Yes
No
Time Frame
For
Data
Submission
6 months
6 months
6 months
6 months
6 months
6 months
ON
I/ Compositions TGAI » technical grade of the active ingredient; PAI » pure active ingredient.
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have .been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
-------
TABLE A GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF FENAMIPHOS
3/ Conplete information must be provided regarding the nature of the process (batch or continuous), the
relative amounts of beginning materials and the order in which they are added, the chemical equations for
each intended reaction, equipment used to produce each intermediate and the final product, reaction
conditions, the duration of each step of the process, purification procedures, and quality control measures.
In addition, the name and address of the manufacturer, producer, or supplier of each beginning material must
be provided, along with information regarding the properties of each beginning material used to manufacture
each product*
4/ A detailed discussion of all impurities that are or may be present at X).1%, based on knowledge of the begin-
ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Conplete validation data (accuracy, precision) must be submitted for each
analytical method used*
6/ Physicocnemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, Kg^, pH, and stability) as required in 40 CFR 158.120 and
more fully described in the Pesticide Assessment Guidelines, Subdivision D must be submitted.
7/ Data needed if the technical chemical is a solid at room temperature.
8/ Data needed if the technical chemical is a liquid at room temperature.
9/ Required if the technical chemical is organic and non-polar. ^j
1_0/ Required if the test substance is dispersible with water.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PENAMIPHOS
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Blblioqraphlc
Citation
Must Additional
Data Be
Submitted?
Time Frame
for
Submission
S158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
TGAI
Yes
(See Index)
PAIRA
Yes
- Livestock
PAIRA & Plant
Metabolites
Partially
00036831
00036837
00038506
00041025
00041027
00041028
00041030
00045595
00045612
00052504
00052509
00052510
00094349
00117405
00119223
00134943
00035114
00036830
00041206
00134943
No
CO
yy
Yes 4/
Reserved
18 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Time Frame
for
Submission
$158.125 Residue Chemistry
171-4 - Residue Analytical
Method
- Plant and animal
residues
TGAI &
Metabolites
Partially
171-4 - Storaqe stability
data
PAI and metabolites
Partially
00025103
00025115
00052495
00052526
00105945
00112903
00112904
00118794
00119223
00121865
00128729
00036839
00045605
00052494
00056049
00112903
00117753
00118794
00119223
00152195
Yes
15 months
6/T/B/
Yes
NO
18 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test
Substance
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Time Frame
for
Submission
5158.125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group II - Bulb Vegetables Group
0 Crop 1 Garlic TEP
- Crop Group 12 - Brassica Leafy Vegetables Group
0 Crop 1 Brussels TEP
sprouts !
Partially
Yes
0 Crop 2 Cabbage
TEP
Yes
00103094
00153468
00036826
00036829
00038522
00052508
00118790
00036827
00118790
00119223
00152195
00154528
Yes
6 Months
No
CO
CD
No
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data Be for
Submitted?Submission
5158.125 Residue Chemistry
-171-4 Magnitude of the Residue
- Crop Group 13 - Legume Vegetables Group"
0 Crop 1 Soybeans EP
— Processed Food/Feed
Partially
Crop Group 14 - Citrus Fruits Group
0 Crop 1 Grapefruit
0 Crop 2 Lemons
14/
00038507
00038508
00109257
00154503
00154528
Yes
ll/
24 months
Yes
Yes
0 Crop 3 Limes
Yes
00038510
00038511
00056049
00101570
00038509
00038510
00049668
00056049
00101570
00038510
00038511
No
CO
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FfNAMIPHOS
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Biblioqraphic
Citation
Must Additional
Data Be
Submitted?
Time Frame
for
Submission
S158.125 Residue Chemistry
-171-4 Magnitude of the Residue
- Crop 9roup 14 - Citrus Fruits Group continued
— Crop 4 Oranges
Yes
00036841
00036842
00038510
00038511
00049668
00056049
00098611
00117406
00134808
00154528
No
CO
— Crop 5 Tangerines
Yes
00038504
No
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data Be for
Submitted? Submission
S158.125 Residue Chemistry
-171-4. Magnitude of the Residue
Group 15 Pome Fruits
0 Crop 1 Apples
Yes
Group 16 Stone Fruits
0 Crop 1 Cherries
Crop 2 Peaches
16/
Yes
Yes
Group 17 Small Fruits and Berries
0 Crop 1 Grapes EP
— Processed Food/Feed
12/
Partially
00029106
00112904
00118794
00029106
00112903
00112904
00118794
00029106
00112904
00118794
00028849
00076988
00098611
00105945
00154528
No
No
No
Yes
IB/
CD
24 months
Crop 2 Raspberries
EP
Yes
00087556
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TABLE A
GENERIC DATA REQUt REMENTS FOR FENAMIPHOS
Data Requirement
Tost
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
ji58.jL.25 Residue Chemistry,
-171-4. Magnitude of the Residue
- Crop Field Trials
-Miscellaneous Connedities
0 Asparagus
0 Bananas
Yes
Partially
00128729
00025103
00025112
00025114
00075270
Must Additional
Data Be
Submitted?
No
Yes
19/
Time Frame
for
Submission
6 months
0 Cocoa beans
— Processing Study
EP
TEP
Partially 00165546
Yes
24 months
6 months
20/
18 months
22/
Cottonseed
EP
Partially
00052511
00052518
00055868
00117754
00118790
00154528
Yes
24 months
6 months
24/
OO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Test
Data Requirement Substance
5158. 125 Residue Chemistry
-Miscellaneous Commodities
0 Okra
0 Peanuts EP
— Processed Pood/Peed
0 Pineapple EP
— Processed Food/Peed
0 Tobacco PAIRA
»
Nonbearing Orchard
Crops EP
Meat/Mi Ik/Poultry/
Eggs - Feeding studies
Use Does EPA Bibliographic
Patterns Have Data? Citation
Yes 00106037
Partially 00052501 .
00052525
00078888
Partially 00079585
00117406
00121866
00134943
00157805
Partially 40211201
40220001
No
Partially 00118794
Must Additional
Data Re
Submitted?
No
25
Yes
26/
Yes
Yes
28/ 29/
Yes
30/
Reserved
Time Frame
for
Submission
24 months
24 months
18 months
00
LP
18 months
Meat/Milk - Processing
Studies
00119223
EP
No
Yes
3J/
24 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
S158.125 Residue Chemistry - Continued
FOOTNOTES
V Refer to Product Chemistry Data Requirement tables.
2/ Metabolism studies using ruminants and poultry are required. Animals must be dosed with ring-labeled
fenamiphos for 3 days at a level sufficient to make residue identification and quantification possible. Milk and
egqs must be collected twice daily during the dosing period. Animals must be sacrificed within 24 hours of the
final dose. The distribution and identity of residues must be determined in milk, eggs, liver, kidney,
muscle, and fat.
<
3/ Samples from the studies requested above must also be analyzed using current enforcement methods to
ascertain the validity of these methods.
4/ Should the metabolism of fenamiphos in ruminants or poultry be found to differ significantly from that
in rats, additional swine metabolism studies will be required.
5/ Residues of fenamiphos sulfoxide (FSO) and fenamiphos sulfone (FSO2) in or on plant and animal commodities and
of des-isopropyl fenamiphos, des-isopropyl fenamiphos sulfoxide and des-isopropyl fenamiphos sulfone in animal
commodities must be subjected to analysis by the multi-residue protocols. Protocols for methods I, II
III, and IV are available from National Technical Information Service under Order No. PB 203734/AS. CD
ON
6/ Storage stability data providing definition of storage conditions and intervals under which the combined
residues of fenamiphos, FSO, and FSO2 "ill remain stable in muscle, fat liver, kidney, milk, and eggs.
7/ The storage intervals and conditions of storage of samples used to support all established tolerances
for residues of fenamiphos must be submitted. If plant comrodity samples were frozen for > 3 years,
these data must be accompanied by data depicting the percent decline in residues at the time and under
the conditions specified. On receipt of these data, the adequacy of the aforementioned tolerances
will be reevaluated.
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
5158.125 Residue Chemistry - Continued
FOOTNOTES •-*
§/ All residue data requested in this Standard must be accompanied by data regarding storage intervals and
conditions o£ sample storage. These data must be accompanied by fortification recovery data depicting
the stability of fenamiphos residues of concern in appropriate sample substances under the conditions
and for the time intervals specified.
9/ If the registrant desired a crop group tolerance. Use directions must be proposed, and appropriate
supporting residue data submitted for the additional representative group member onion (green and bulb).
IP/ Information must be provided detailing the mediansims employed to regulate the use of fenamiphos on garlic
grown in all countries which export to the U.S. Such information must include an English language
translation of all product label(s).
If the registrant desires a crop group tolerance use directions must be proposed, and appropriate
supporting residue data submitted for additional representative group members (broccoli and mustard greens).
12/ If the Registrant desires a crop group tolerance, use directions must be proposed and appropriate
supporting residue data submitted for the additional representative group members (beans and peas).
13/ Residue data for dust (grain), soybean hulls, meal, crude oil, and refined oil processed from soybeans bearing
measurable weather residues are required. Exaggerated rates may be necessary to achieve these residue levels.
If residues concentrate in these processed products, appropriate food/feed additive tolerances will have to be
proposed* ,
14/ Based on the available residue data and the use pattern for citrus, a group tolerance of 0.5 pom for residues
in or on citrus fruits appears to be appropriate and will permit compatibility with the Codex MRL.
IS/ If the registrant desires a crop group tolerance, use directions must be proposed and appropriate
supporting residue data submitted for the additional representative group members (pears).
16/ If the registrant desires a crop group tolerance, use directions trust be proposed and appropriate
supporting residue data submitted for the additional representative group member (plums, fresh prunes).
IT/ If the registrant desires a crop group tolerance, use directions must be proposed and appropriate
supporting residue data submitted for additional representative group members (cranberry, blueberry,
and strawberry).
18/ Data depicting fenamiphos residues of concern in juice and dehydrated grape pomace processed from grapes
bearing measurable, weathered residues are required. Upon receipt of the requested data, the established tolerance
for residues in grape pomace may have to be revised. Also, if the data indicate a potential for concentration
in juice, an appropriate food additive tolerance must be proposed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
§158.125 Residue Chemistry - Continued
19/ Approved labels (use directions) from all countries In Which the product Is marketed must be submitted.
Information must be provided detailing the mechanisms employed to regulate the use of fenamlphos on
bananas for the U.S. market. Such Information must Include an English language translation of the
product label(s).
20/ Data depleting the potential for concentration of residues In roasted beans, cocoa powder, and chocolate
processed fron cocoa beans bearing measurable, weathered residues are required. If the data Indicate a potential
for residue concentration In any of these commodities, appropriate food additive tolerances must be proposed.
21/ Information must be provided detailing the mechanisms employed to regulate the use of fenandphos on cocoa
trees grown In all countries from Which cocoa beans are Imported Into the U.S. Such Information must
Include English language translation of the product label(s).
22/ Residue data must be submitted In which crops were treated at maximum permitted label rates and harvested
within 1 day of treatment and at regular Intervals thereafter. Tests must be conducted In representative
countries In which use Is permitted and the crop Is exported to the U.S.
23/ Data depleting residues of concern from meal, hulls, soapstock, crude oil, and refined oil processed fron oo
cottonseed bearing measurable weathered residues. Exaggerated rates may be necessary to achieve these oo
residue levels.
2V The reglstrant(s) must propose a tolerance of 0.1 ppm for residues of fenamlphos In or on cotton forage.
Alternatively, the reglstrant(s) may amend the use directions to Include feeding restrictions for cotton
forage.
25/ Data depleting combine] residues of fenamlphos and Its sulfoxide and sulfone metabolites In meal, crude
oil, refined oil, and soapstock derived from nuts bearing measurable weathered residues. If concentration
of residues occurs during processing, the registrant must propose appropriate food/feed additive tolerances.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
S158.125 Residue Chemistry. - Continued
-FOOTNOTfcS- "~
26/ Data from a processing study depicting the combined residues of fenamiphos and its sulfoxide and sulfone
metabolites in pineapple juice and dried pineapple bran processed from whole pineapple fruit (excluding
crown) bearing measurable weathered residues. If the requested data indicate a concentration of residues
in pineapple juice and/or a concentration factor in dried pineapple bran greater than 33, then appropriate
food and/or feed additive tolerances must be proposed.
27/ Pyrolysis products derived from the active ingredient must be characterized and the level of residue
in tobacco smoke must be quantified. (Weathered residues of (14C1 fenamiphos must be used for identification
of pyrolysis products).
28/ Residue data for tree nuts grown from nursery stock which had been treated with single applications of the
~~ 15% G or 3 Ib/gal EC formulation at 18 Ib ai/A are required. The tests must be conducted in California.
Alternatively r the registrant may elect to cancel this use permitted under Section 24 (c) Special Local Need
registrations.
Residue data for pears grown from nursery stock which had been treated with the 15% G or 3 Ib/gal EC
formulation at 20 Ib ai/A are required. The tests must be performed in Oregon. Alternatively, the registrant
may elect to cancel this use permitted under Section 24 (c) Special Local Need registrations.
30/ We note that the nature of the residue in animals is not adequately understood and outstanding data gaps
exist for many processed feed items. Upon receipt of the data requested in the sections "Nature of the
Residue in Animals" and "Magnitude of the Residue in Animals", the established tolerances will be
assessed, and the adequacy of the available data regarding the magnitude of residues will be determined with
consideration for any additional metabolites of toxico logical concern.
31/ Processing studies are required that demonstrate the effect of cooking (meat) and pasteurization or production
of infant for mi la (milk) on residue levels of fenamiphos and its sulfoxide and. suit one as well as des-isopropyl
fenamiphos, des-isopropyl fenamiphos sulfoxide, and des-isopropryl fenamiphos sulfone. A protocol should be
submitted for Agency approval prior to initiation of the study.
CO
v°
-------
^ TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
$158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA A,B
Photodeqradation
161-2 - In water TGAI or PAIRA A,B
161-3 - On soil TGAI or PAIRA A
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA A,B
162-2 - Anaerobic Soil TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA A,B
Adsorption Absorption
163-2 - Volatility (Lab) TEP A
163-3 - Volatility (Field) TEP A
Yes
Yes
No
No
No
No
No
No
No
No
No
00079270 No
00133402 No
Yes
No1'
Yes
Yes
I/
No
I/
No
Yes
Yes
Reserved
9 Months
27 MontJ§
27 Months
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test
Substance
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
158.142 Spray Drift
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
TEP
TEP
A,B No
No
No
No
A No
A No
A No
No
A,B No
No
A,B No
A,B No
Yes
V
No
No
I/
Reserved
Yes
Yes
Yes
Yes
NO
Yes
27 Months
50 Months
39 Months
50 Months
39 Months
12 Months
6 Months
6 Months
-------
A
GENERIC DATA REQUIREMENTS FOR FENAMIPHDS
5158.130 Environmental Fate - Continued I
I/ Not required based on the use pattern of fenamiphos.
2/ Reserved pending results of the laboratory volatility study.
3/ Tank mix data requirements are not being imposed by this standard.
4/ Soil( long term stud/ is reserved pending the results of aerobic soil metabolism and field dissipation
studies.
S/ The spray drift droplet spectrum and field evaluation may be done together in order to evaluate the
droplet spectrums that are associated with actual field use patterns.
\O
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPB06
Date Requirement
5158.135 Toxicoloov
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
81-7 - Delayed
Neurotoxicity - Hen
SUBCHRDNIC TESTING:
82-1 - 90-Day Feeding:
- Rodent, and
- Non-rodent (Dog)
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A
A
Does EPA
Have Data?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation
00033831
00037962
00154492
00082111
00082111
00148464
00057606
•
00117403
00119240
00133475
00117403
00154493
Must Additional
Data be
Submitted
No
No
No
No
No
No
No
No
No
Time Frame
for
Submission
\O
82-2 - 21-Oay Dermal - Rabbit TGAI
A,B,G
Yes
00154497
No
-------
TABLE A
GENERIC DATA RBQUIRRMEms FOR FENAMIPHOS
Data Requirement
$158.135 Toxicology. - Continued
SUBCHRDNIC TESTING CONT'D:
82-3 - 90-Day Dermal - Rabbit
82-4 - 21-Day 'Inhalation:
- Rat
82-5 - 90-Day Neurotoxicity:
CHFONIC TESTING:
83-1 - Chronic Toxicity -
2 species:
- Rodent, and
MMM Kin ^n«* §• 1 fVw \
— Non-rodent \uocj)
83-2 - Oncorjenicity -
2 species:
- Rat (pref erred )r and
- Mouse (preferred)
83-3 - Teratoqenicity -
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat
Test
Substance
TGAI
TGAI
TGAI
TGAI
•W5AT
IVjfti
TGAI
TGAI
TGAI
TGAI
TGAI
Use Dees EPA
Patterns Have Data?
— No
— No
-- No
A Yes
AVAfl
xes
A Yes
A Yes
A No
A No
A Yes
Bibliographic
Citation
—
00161361
00133475
nnm7Qfi*»
uuvjj iy\jj
00154493
00161361
00098614
--
00121286
00037979
Must Additional
Data be
Submitted?
No^
y
Yes
y
No
No
Mo
WO
No
No
Yes
Yes
No
Time Frame
for
Submission
12 Months
vC
4*
15 Months
15 Months
2-qeneration
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement Test Use
Substance Pattern
S158.135 Toxicoloqy - Continued
MLTTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI A,B,G
— / — structural cnromosomai TGAI A»B»G
Aberration
84-4 - Other Genotoxic Effects TGAI A,B,G
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A
85-2 - Antidotal TGAI A,B,G
Does EPA Bibliographic
Have Data? Citation
Yes 00159027
Yes 00086981
No
Partially 00041022
00041023
00052527
00033831
Yes 00082807
Must Additional Time Frame
Data be for
Submitted? Submission
No
No
Yes 12 Month;
Yes 24 Mon
No vo
en
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FKNAM1PHOS
SI58.135 .ToxioolggVLr Continued
I/ The registered uses do not require a 90-day dermal study.
2/ A test with duration of 21 days is required if product is used on tobacco.
3/ Fenamiphos was negative for neurotoxicity in the acute delayed neurotoxicity study (81-7) and is without evidence
of neurotoxicity in other manualian test species.
4/ Additional testing is required to assess direct DMA damage.
5/ A Guideline multiple-dose rat metabolism study is required.
O\
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
SJL5_fl •JL4JL, Reentry Protection
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
A,B
A,R
No
No
No
No
Yes
Yes
3
Yes"
3
Yes"
y
27 Months
27 Months
27 Months
27 Months
I/ For each end-use, the Registrant is required to propose an acceptable reentry interval based either upon;
data on dissipation of residues (decline curve), human exposure to those residues, and toxicity of
the residues; or upon a determination of that time beyond which there are no detectable dislodgeable or
inhalable residues remaining in the worker/occupant environment. If the Registrant has. reason to believe
that an end-use will not cause exposure to residues, a request for waiver from this data requirement should
be submitted.
2/ Soil dissipation data are required only for uses where workers will be exposed directly to substantial
quantities of soil during their work, e.g. for use on cotton where hand harvesting will be performed.
3/ Human exposure monitoring data nust be submitted if the Registrant wishes to use the "allowable exposure method" of
determining reentry intervals. If exposure studies are submitted, both dermal exposure and inhalation exposure must
be submitted. If exposure studies are not submitted, human exposure (and reentry intervals) would be estimated Erom
dislodqeable residues as explained in Subdivision K.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHDS
Data Requirement
S158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing
- Mammals, and
- Birds
- Actual Field Testing
- Mammals, and
- Birds
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
Use
Pattern
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
Yes 00121289
Yes 00025959
Yes 00025958
N/A
Yes 00121291
Yes 00121290
No
No •
No
No
Must Additional
Data be
Submitted?
No
No
No
y
No
No
No
y
Yes
Yes
y
Yes
y
Yes
Time Frame
for
Submission
NO
09
48 months
48 months
48 Mont^
48 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data
$158
Requirement
.145 Wildlife and
Aquatic Organisms - Cont
Test
Substance
inued
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
AQUATIC ORGANISM TESTING
72-1
-
72-2
- Freshwater Fish Toxicity
- Coldwater Fish Species,
and
- Warmwater Fish Species
- Coldwater Fish Species
- Warmwater Fish Species
- Warmwater Fish Species
- Acute Toxicity to
Freshwater Invertebrates
TGAI
TGAI
TEP
(21 & 35% EC)
TEP
(21 6 35% EC)
Sulfoxide
deqradate
Sulfone
deqradate
TGAI
TEP
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Yes 00114012
Yes 00025962
Partial 00114012
Partial 00114012
Yes 00025962
00114015
Yes 00025962
No 00025960
No
No
I/
Yes
Yes
No
No
Yes
«/
Yes
9 Months
9 Months
vO
9 Months
9 Months
(21 6 35%)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPH06
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
$158. 145 Wildlife and
AQUATIC
Aquatic ^Qjrganjlsns - Continued
\
ORGANISM TESTING
72-3 - Acute Toxicity to
72-4 -
72-5 -
Estuarine and Marine
Organisms 5/
- Fish TGAI A,B No 00094220 Yes
- Mollusk TGAI A,B No 00094220 Yes
- Shrimp TGAI A,B No 00094220 Yes
y
Fish Early Life Stage, TGAI A,B No Yes
and
- Aquatic Invertebrate TGAI ArB No Yes
Life-Cycle
Fish - Life-Cycle TBP A,B No Yes
12 Months
12 Months
12 Months
15 Months
15 Months
27 Months
0
o
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
5158.145 WildUfe and
T " Ajjuatjtc Qr^aniams - Continued
72-6 - Aquatic Organism TEP
Accumulation
- Crustacean
- Fish
— Insect Nymph
- Mollusk
72-7 - Simulated Field Testing TEP
- Aquatic Organisms
%
- Actual Field Testing TEP
-Aquatic Organisms
A,B
No
Yes
A,B
A,B
No
No
Yes
I/
Yes
2/
12 Months
12 Months
12 Months
12 Months
48 Months
48 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENAMIPHOS
5158* 145 Wi Idlife and Acpjatijc Organisms - Continued
I/ The Agency will use acute toxicology data to satisfy this requirement.
2/ Actual field testing with birds and manuals is required as per 40 CFR 158.145 with a typical granular formulation.
Initial sites to be tested, based on application rates and wildlife usage information, include tobacco, citrus, sod
and turf (broadcast applications). The application rates to be used are the lowest rates that are still
efficacious as indicated by the required efficacy data (Appendix I, Table B, S 158.160). Initial testing must include
a stud/ of dietary exposure and thorough carcass searching to determine whether there is pesticide induced mortality,
and if so, its extent. Examination of the citrus use must also determine, by nest survey, whether avian breeding is
disrupted, and collect complete natality, mortality, emigration, and immigration data. It must be determined, by
mark-recapture techniques, whether mammalian populations are also affected. Also required is a field study of band
application of the 15G formulation in fruit trees at 20 Ib ai/A, with carcass searching as above. Multiple sites
are required for all use patterns studied. Additional field testing is reserved pending results of these studies
and additional environmental fate testings. Cancellation of any of the above use patterns would obviate the need
for testing of these uses. However, since further studies are pending the results of the above initial testing,
other sites may be required to be substituted. The Agency requires protocols for conducting the studies be submitted
for review within 6 months of the issuance of the standard and accepted by the Agency prior to initiation of field
work. The study is due 48 months from publication of this Registration Standard but annual progress reports must be
submitted for the duration of the study. A guidance document is available from the Agency which outlines an — *
acceptable approach to these studies and the Agency encourages registrants to consult with Agency staff for assistance^
if required. ^
3/ Accepted studies were conducted on the 15G, but additional studies must be conducted on the
35 and 21% spray concentrate products. Estimated EECs from recommended application rates exceed
the LC values.
4/ Product is highly toxic fungicide and Estimated Environmental Concentrations (EECs) are likely to exceed 48-hour
for the technical material.
5/ To support citrus, cotton, and peanut uses (crops exceeding 300,000 acres in coastal counties)
and tobacco of which 56% is treated with fenamiphos.
6/ Test required because I£5Q values for warm- and coldwater fish species were less than 1 mg/L
LC50 values.
T/ The Agency requires protocols for conducting the studies be submitted for review within 6 months of the issuance
of the standard and accepted by the Agency prior to initiation of field work. The study is due 48 months from
publication of this Registration Standard but annual progress reports must be submitted for the duration of the
study. A guidance document is available from the Agency which outlines an acceptable approach to these studies and
the Agency encourages registrants to consult with Agency staff for assistance, if required. The application rates
to be used are the lowest rates that are still efficacious as indicated by the required efficacy data
(Appendix T, Table n §158.160).
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING FENAMIPHOS
Does EPA Must Additional Time Frame
Have Data to Bibliographic Data Be Submitted For
I/ Satisfy This 2/ 2/ Under FIFRA Section Data
Data Requirement Composition Requirement? Citation 3(c)(2)(B)7 Submission
158.120 Product Chemistry
Product Identity and Composition
6T-1 - Product identity andlJisclosure MP No
of Ingredients
61-2 - Description of Beginning Mater- MP No
ials and Manufacturing Process
•1-3 - Discussion of Formation of MP No
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product MP No
Samples
62-2 - Certification of Ingredient MP No
Limits
62-3 - Analytical Methods to Verify MP No
Certified Limits
N/A
N/A
N/A
N/A
N/A
N/A
y
Yes
V
Yes
y
Yes
Yes
y
Yes
y
Yes
6 months
6 months
6 months
_^
O
12 months
12 months
12 months
(continuedr footnotes follow.)
-------
TABLE B. PRDOUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING FBNAMIPHOS
Does EPA Must Additional Time Frame
Have Data to Bibliographic Data Be Submitted For
I/ Satisfy This2/ 2/ Under FIFRA Section Data
Data Requirement ^ ^Composition Requirement? Citation 3(c)(2)(B)7 Submission
158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
,
63-14 - Oxidizing or Reducing Action
63-15 - Flammability
63-16 - Explodabtlity
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64-1 - Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A
Nd
Nd
Nd
Nd
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
9/10/
Yes
2/il/
Yes
9/12/
Yes
9/13/
Yes
Yes
9/14/
Yes
9/15/
Yes
Yes
No
6 months
6 months
6 months
6 months
6 months
6 months — *
0
6 months •**
6 months
15 months
6 months
6 months
15 months
(continued, footnotes follow).
-------
TABLE B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING FENAMIPHOS
I/ Composition: MP * Manufacturing Use Product.
2/ Not applicable* Although product chemistry data may have been submitted in the past, the Agency has determine
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data mist be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration. Chemical Abstracts (CAS) Registry Number, an
purpose of the active ingredient and each intentionally added inert must be provided. For the active ingredien
the following must also be provided: the product name, trade name, and coiimjn name; the molecular, structural,
and empirical formulas; the molecular weight or weight range; and any experimental or internally assigned compa
code nurnbers.
4/ Complete information mist be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
V A detailed discussion of all impurities that are or may be present at >0.1%, based on knowledge of the begin-
^ ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted.
6/ Five or more representative samples must be analyzed for the amount of active Ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
-------
TABIJ5 B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING FENAMIPHOS
I/ Upper and lower limits for the active Ingredient and each intentionally added inert, and upper limits Tor each
"~ Impurity present at X).l% (w/w) and each "toxlcologlcally significant" :lmpurity present at
-------
TAKE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURINO-USE PRODUCTS CONTAINING PENAMIPHOS
Data
S158.
Requirement Test
Substance
.135 Toxicology
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxlclty - Rat
- Acute Dermal Toxlcity
- Rabbit
- Acute Inhalation Toxlclty
- Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irrl cation - Rabbit
- Dermal Senslttzatlon -
MP
MP
MP
MP
MP
MP
A,B,G
A,B,G
A,B,G
A,B,0
A.B.O
A,B,0
Yes
No
No
No
No
No
0033831
0037962
015M92
00082111
00082111
00148464
No
No
*
No
No
No
No
Guinea Pig
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS F0R END-USE PRODUCTS CONTAINING PENAMIPHOS
Data Requirement
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
S.158..160. Product Performance
96-10 - Nematicides
TEP
A,B,G
No
Yes
6 Months
O
00
-------
APPENDIX II
LABELING
-------
109
SUMMARY-l
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if It is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor Is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3* NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
Immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CPR I62.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
tfeg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
labe.L on which It appears and must run parallel to It. The
registration number and the required Identifying phrase must
not appear in such a manner as to suggest or Imply recommendation
or endorsement of the product by the Agency.
[40 CPR I62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
In any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the Immediate
container cannot be clearly read through such wrapper or container.
[40 CPR I62.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The Ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight.of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CPR I62.10(g)]
-------
no
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active Ingredient
must be Indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
In Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point . . 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use Is unlikely. [40 CFR I62.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) Is required on the front panel Immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(!)(!)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxiclty Category I on the basis of oral, dermal,
/or Inhalation toxiclty, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear In*Immediate proximity to
the word POISON. [40 CFR 162.10(h)(!)(!)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products In toxiclty Categories I,
II, and III. [40 CFR 162.10(h)(l)(iii)3
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or liack) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iil)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR I62.10(h)(2)].
-------
1U
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required Indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident. Injury or damage. £40 CPR I62.10(h)(2)(1)3
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, Injury, or damage. [40 CPR I62.10(h)(2)(ll)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - PLAMMABILITY
Precautionary statements relating to flammablllty of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammabllity statements.
Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be Imposed by regulation).
/
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any Information and
rationale with your application for rereglstration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CPR I62.11(c). You will be notified of
the Agency's classification decision.
-------
112
SUMMARY-.*
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table In 40
CPR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of .restriction must
appear (Including the reasons for restriction if specified
in Section 1). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
1 If you do so, you may Include on the label uses that
are unrestricted,.but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
rereglstratlon, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this-product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements nay be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These Instructions must be grouped and
appear under the heading "Storage and Disposal11 in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated In terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CPR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which Is to accompany the product
are termed collateral labeling. Such labeling nay not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
HEM
I
2
3
-------
SUMMARY-7
HEM
7C
7D
7E
8
HA
HB
Skull & cross-
bones and word
POISON (In red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
%
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or Inhala-
tion toxlclty
All products
In Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
In Categories
I, II, and III
All products
PLACEMENT ON LABEL
KEQUiREb
Front panel
Category I:
Front panel
unless refer-
ral statement
Is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREhTiKHKD
Both In close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings In
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards Include bee
caution where applicable.
-------
SlHMARY-8
HEM
8C
9A
9B
10A
10B
IOC
fljfl|jfli|j IVU^iPldPl JL
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
%
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
fKfcJf'fcKHKU
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement Is:
"It Is a violation of Federal law
to use this product In a manner
Inconsistent with Its labeling.11
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
Information and required statements.
May be in metric as well as U.S. units
-------
M7
PHYS/CHEM-l
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or If there Is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
If the flame extension
Is more than 18 Inches
long at a distance of
6 Inches from the
valve opening.
C. All Other Pressurized
Containers
Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. 'Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
118
STOR-l
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
Intended solely for domestic use need not Include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
Instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might Include
positioning of the container In storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs,
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement In
locked storage areas.
-------
119
PEST/DIS-I
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those Intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active Ingredients that are Acute Hazardous
Wastes or are assigned to Toxiclty Category I on the basis of oral or
dermal toxlclty, or Toxiclty Category I or n on the basis of acute
Inhalation toxlclty must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rlnsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label Instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance.11
3. Tiie labels of all products, except those Intended for domestic use,
containing active or Inert Ingredients that are Toxic Hazardous Wastes
or meet any of the criteria In 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:.
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
/ spray mixture, or rlnsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label Instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those Intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products Intended for domestic use only must bear the following
disposal statement: "Securely wrap original container In several layers
of newspaper and discard In trash."
-------
120
CONT/DIS-l
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Sor.tainer Type Statement
Non-aerosol proBucts
(bottles, cans, Jars)
Non-aerosol products
(ba-s)
Aerosol products
Do not reuse container (bottle, can, Jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers In
trash. Do not Incinerate or puncture.
2. All other products must bear container disposal Instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Elastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or
Incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of In a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner In a
sanitary landfill or by incineration If
allowed by state and local authorities.
If drum is contaminated and cannot be
reused1, dispose of In the same manner.
Completely empty bag Into application
equipment. Then dispose of empty bag In
a sanitary landfill or by incineration,
or, If allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
APPENDIX III
USE INDEX
-------
EPA Index to Pesticide Chemicals
ETHYL 3-METHTL-4-(>ttTHTLTHIO)PBENTL 1-(KZTHYLETHYL)
PHOSPHOLAMIDATE (9CA)
TABU 07 CONTENTS
Site Haae Page
TERRESTRIAL fOOD OLOP , 2
(Agricultural Crops) 2
Apple 2
Brussels Sprouts (transplanted) 2
Cabbage (direct seeded and transplanted) 3
Cherry 2
Citrus ' 3
Cotton 4
Crapes . 4
Okra .- ' 5
Peach • 2
Peanuts 7
Pineapple 6
laspberry 8
Soybeans 6
•
TERRESTRIAL BONFOOD PLOP 9
(Agricultural Crops) 9
Apple (nonbearlnf/nursery stock) 9
Cherry (nonbearlng/nursery stock) 9
Citrus (nonbearlnf /nursery stock) 10
Prult Trees (nonbearlnf/nursery stock) 10
Crapes (nonbearing/nursery stock) ^ 10
Hut Trees (nonbearlnf/nursery stock) 10
Peach (nonbearing/nursery stock) 9
Pears (nonbearlnt/nursery stock) 11
Tobacco 11
(Ornaaeotal Plants and Porest Trees) 13
AJuga, 'Metallic*' (nursery stock) 13
Anthurlum 13
Azalea (nursery stock) 13
lenttrats 14
Beraudagrass 14
lluegrass 14
Boxwood (nursery stock) 13
Cacti (nursery stock) 13
Centlpedegrass 14
Qeastls (nursery stock) 13
Cotoneaster (nursery stock) 13
English Ivy, 'Baltic* (nursery stock) 13
Euonyaus (nursery stock) 13
Pirethorn (nursery stock) 13
Plovering Cherry (nursery stock) 13
Flowering Crab (nursery stock) • 13
Gardenia (nursery stock) 13
Hibiscus (nursery stock) 13
Holly (nursery stock) 13
Iris (bulbs) * 14
Issued: 4-14-86 HI-100601-1
-------
122
EPA Index to Pesticide Chemicals
ETHYL 3-METHYt-4-(METHYI.THIO)PHENYL l-(METHYLETBYL)
PHOSPBORAMIDATE (9CA)
TABLE OF CONTENTS
Site Ha»e Page
Iris (nursery stock) 13
Japanese Aadroneda (nursery stock) 13
Juniper (nursery stock) 13
Leatherleaf Pern IS
Lily (bulbs) 14
Karcissus (bulbs) 14
Ornamental Plover Bulbs . 15
Ornamental Trees (nursery) ' 15
Ornamental Woody Vines (nursery) 15
Pachysandra (nursery stock) . • 13
Periwinkle (nursery stock) •" 13
Pine (nursery stock) 13
Plantain-Lily, 'Crandiflora* (nursery stock) 13
Protaa 15
Uhododendron (nursery stock) 13
lose (nursery stock) 13
Sedua (nursery stock) 13
Spruce (nursery stock) 13
Viburnum (nursery stock) 13
Tew» (nursery stock) 13
Yucca (nursery stock) 13
Issued: 4-14-86 XII-100601-ii
-------
123
EPA Index to Pesticide Cheaicals
•100601 ETHYL 3-METHYL-4-(lfETHYLTHIO)?HElfTL l-(METHYLETHYL)
PBOSFBORAMIDATE (9CA)*
TTPE PESTICIDE; Keaaticide, Insecticide
FORMULATIONS;
Tech (85Z)
?I (72.31)
C (5X. 101, 151)
EC (2 Ib/gai. 3 Ib/gal)
GENERAL WARNINGS AMD LDCTATIOHS; The 2 and 3 pound per gallon eaulsifi-
•ble concentrate formulations are KCSTB1CTED DSC PESTICIDES. Mixer/load-
ers must veer protective coveralls, rubber or meoprene boots, rubber or
aeoprene gloves, .end goggles or fece shields ahen handling -products con-
taining this cheaical. Any person coming in direct contact vith treated
water, and/or treated soil prior to incorporation or irrigation, must wear
protective coveralls', rubber or neoprene boots and rubber or aeoprene
gloves. Do not grace treated areas or feed cover crops grown in treated
areas to livestock.
Dosage rates are given in active ingredient.
Agricultural Tolerances (other than those listed in the text):
Asparagus
Bananas
Cocoa beans
Garlic
Crape fruit
Lemons
Limes
Oranges
Tangerines
0.02 ppa
0.1 ppa
0.02 ppa
0.5 ppa
0.6 ppa
0.6 ppa
0.6 ppn
0.6 ppn
0.6 ppa
Livestock Tolerances:
Cattle, fat
Cattle, meat
Cattle, mbyp
Coats, fat
Coats, meat
Coats, mbyp
Bogs, fat
Bogs, meat -
Bogs, mbyp
Borses, fat
Borses, meet
Boraes, mbyp
Milk
Sheep, fat
Sheep, meat
Sheep, mbyp
Definition of Ter
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppm
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
0.05 ppa
ms:
SLN - Special Local Reeds
*fenaaiphos
Meaacur
Issued: 4-14-86 III-100601-1
-------
124
EPA Index to Pesticide Chemicals
1THYL 3-METHYL-«-(METHYLTHIO)PHEHYL l-(HETHYLETHYL)
FHOSPHORAMDATE (?CA)
Site and Pest
TERRESTRIAL FOOT CROP
(Agricultural Crops)
Dossges and Tolerance, Use, Liaitatieni
Fornulstion(s)
/04001AA
/04001DA
/05002AA
/05002DA
/05004AA
/05004DA
0.25 ppa (apple, cherry, peach)
For all areaa except CA.
Do not apply within 72 days of har-
vest for apples, or within 45 days
of harvest for peaches or cherries.
Do vet apply more than 20 pounds per
year per planting aite. Avoid con-
tacting foliage with the apray mix-
ture or with the granular material.
Hem*todes
10-20 Ib/A
(10X, 15X G)
Soil treat
Band application:
Apply specific dosage (in 20 to 40
003125-00237 gallons of water for the spray) as
(3 Ib/gal EC) apray or granules to the aoil aur-
003125-00283 face with equipment properly cali-
brated to apply fenamiphos in a band
covering the feeder root aystea of
the tree. Incorporate immediate 2
to 4 inches deep. Broadcast appli-
cation is accomplished siaiiar to
that described above, but is uni-
formly applied to the entire orchard
area to be treated.
/13006AA
RA&AAAA
Brussels Sprouts (transplanted) 0.1 ppa
Vematodes
1.65-3.3 ox/
1,000 ft of
row
or
4.0-6.0 Ib/A
(151 C)
Soil treataent. Band application;
Apply apecific dosage in ounces per
1,000 feet of row in front of the
planting shoe as a 12 to 15 inch
band. Incorporate the granules into
the aoil to a depth of 2 to 6 inch-
003125-00236 es. Broadcast application; Distri-
bute the granules uniformly over the
entire area to be treated. For both
the band and broadcast treatments,
use the high rate in fields with
high nematode population, or in
fields having a history of serious
tode damage.
Issued: 4-14-86
II1-100601-2
-------
125
EPA Index to Pesticide Chemical*
ETHYL 3-«THYL-4-(METHYLTHIO)PHENYI. l-(METHYLETHYL)
PHOSPHORAMIDATE (9CA)
Site and Pest
Dossies and Tolerance, Pse, Limitations
Pormulation(s)
/13007AA
HABAAAA
Cabbage (direct aeeded and tram- 0.1 ppm
planted)
Veaatodes
1.65-3.3 or/
1,000 ft of
row
or
4.0-6.0 Ib/A
(151 C)
/02000AA
/
KABAAAA
Soil treatment. Band application:
Apply apecifie dotage in ounces per
1,000 feet of row in front of the
planting ahoe at a 12 to 15 inch
band. Incorporate t*»e granules into
the aoil to a depth of 2 to 6 inch-
003125-00236 as. Broadcast application: Distri-
bute the granules uniformly over the
entire area to be treated. For both
the band and broadcast treatments,
use the high rate in fields with
high nematode population, or in
fields having a history of serious
nematode damage.
See Apple cluster.
0.6 ppm
for use in AZ and TX only.
Do not apply within 160 days of har-
vest. Do not apply acre than once
per aeason.
Neastodes
10-20 Ib/A
(101, 15Z C)
003125-00237
(3 Ib/gal EC)
003125-00283
Soil application. Band treatment;
Apply apecifie dosage (in 20 to 40
gallons of water for the apray) as
apray or granules to the aoil sur-
face with equipment properly cali-
brated to apply fenamiphos in a band
cantered on the rov and applied out-
ward to the driplina. (Example:
To treat trees planted on 20 foot
centers with a 10 foot band centered
on the rov, apply 0.5 the broadcast
rate.) Broadcast application is ac-
compliahed similar to that described
above, but is uniformly applied to
the entire area of the orchard. For
both the broadcast and the band ap-
plications, follow immediately and
incorporate 2 to 3 inches into the
aoil or apply sufficient irrigation
water for incorporation (0.5 to 1
inch for dry conditions).
lasued: 4-14-86
III-100601-3
-------
126
EPA Index to Pesticide Chemical§
ETHYL 3-METHTL-4-(MBTHYLTHIO)PHEHYL l-(METHYLETHYL)
PBOSPBORAMIDATE (9CA)
/2100LAA
•AJAAAA
IMOAAAA
Site and Pest
Cotton
Nematodes
Thrips
DCAAAA
Thrips
/01020AA
VABAAAA
Crapei
Rematodes
Dosages and Tolerance, Pee, Limitation*
Formulation(a)
0.05 ppn (cotton aeed)
Soil application. In farrow/cover-
ing aoil; Apply apecific doaage (as
granule* or apray) per 1,000 feet
of row in furrow or band in covering
•oil behind the aeed drop. Band;
Apply apecific doaage per 1,000 feet
of row (as granules or apray) in a
6 to 12 inch band ever the row. In-
corporate thoroughly to insure uni-
form distribution. Dae the highest
recommended rates in fielos with a
history of nematode problems.
Soil application. In furrow/cover-
ing soil; Apply apecific dosage (as
granules or apray) per 1,000 feet
of row in furrow or band in covering
aoil behind the aeed drop and in
front of the covering devices.
1.0-2.2 Ib/A
on 40 in.
row apacing
or
1.2-2.7 ox/
1,000 ft of
row
(10Z, 15Z C)
003125-00237
(3 Ib/gal CO
003125-00283
0.75-1.0 Ib/A
on 40 in.
row apacing
or
0.9-1.2 ox/
1,000 ft of
row
(10Z, 15Z C)
003125-00237
(3 Ib/gal EC)
003125-00283
0.1 ppm
9.0-18.0 Ib/A Soil application (for use east of
(3 Ib/gal EC) the tocky Mountains). Broadcast;
003125-00283 Apply apecific dosage in 20 to 40
gallons of apray aolution per acre
to the aoil with auitable ground
equipment and incorporate 2 to 4
inches deep. Band; Use proportion-
ally less fenamiphoa per acre.
Treated band should center on vine
row with a minimum vidth of 50 per-
cent of the row apacing. Ineoporate
immediately. (If the band is half
the row vidth, use 0.5 the rate.)
9.0-18.0 Ib/A Soil application (for use west of
(3 Ib/gal EC), the locky Mountains). Broadcast;
With ground injection equipment, ap-
ply apecific dosage per acre in 20
to 40 gallons of aolution 2 or more
inches balow the aoil aurface.
Issued: 4-14-86
II1-100601-4
-------
127
EPA Index to Pesticide Chevied•
E"THYL 3-KETm-4-(METHYLTHIO)PHENYL l-(KETHYLETHYL)
PHOSPHORAMIDATE (9CA)
Site and Pest
Crapes (continued)
15015AA
Okra
Dosages end Tolerance. Dae, Limitations
Porraulation(s)
Band; With ground injection equip-
ment, apply specific dosage per acre
in 20 to 40 gallons 2 or ecre inches
below the coil surface. Center the
treated band on tbe vine row using
a minimum band width equal to 50
percent of the row spacing (with a
band width equaling 50 percent of
the row'spacing, use 0.5 the broad-
east rate).
0.3 ppm
For all areas except CA.
When band applications are sude to
narrow row crops, do not use band
widths that will allow the treated
areas to overlap.
VABAAAA
Mematodes
2.1-2.5 Ib/A
(151 C)
Soil application. Broadcast. Dis-
tribute uniformly over the entire
Peach
003125-00236 area to be treated and ieaediately
incorporate to a depth of 2 to 6
inches by disking or tilling.
2.2-2.76 ot/A Band. Apply specific dosage in
(152 C) ounces per 1,000 feet of rev in
front of the planter shoe as a 12
to 15 inch band. Incorporate the
granules into the soil to a depth
of 2 to 6 inches.
See Apple cluster.
Issued: 4-14-86
II1-100601-5
-------
128
EPA Index to Pesticide Cheaicals
ETHYL 3-METHYL-4-(METHYLTHIO)PHENYL l-(METHYLETHYL)
PBOSPRORAHIDATE (9CA)
Site and Pest
Dosages and Tolerance, Psc, LJMJ tat ions
Formulation(a)
/06013AA
Pineapple
(for use in HI only)
HEOBCAA
KHBBAA
0.3 ppa
Do not apply within 30 days before
. harvest. Do not use green forage
and fodder for aniaal feed. Do not
.apply acre than 40 pounds fenamiphos
per acre per plant crop or More than
20 pounds per acre per ratoon crop.
Kenatodes 0.5-3.0 Ib/A Plant crop; Soil or water treat-
(Meloidogyne spp.) (3 Ib/gal EC) vent. Apply apecific dosage in 50
Hen*todes 003125-00283 to 250 gallons per acre as a broad-
(Rotylenehulus east apray or through drip irriga-
app. J tion. Applications May begin i«me-
diatcly after planting. Make addi-
tional applications at intervals of
1 to 3 wraths as needed.
Katoon crop; Soil or water treat-
vent. Apply specific dosage in 50
to 250 gallons per acre as a broad-
cast spray or through drip irriga-
tion. Application May begin imme-
diately after crop harvest. Make
additional applications at intervals
of 1 to 3 Months as needed.
(for use in PR only)
Do not apply within 7-1/2 Months
before harvest. Do not use green
forage and fodder for animal feed.
Do not apply More than 20 pounds
fenaaiphos per acre per aeaaon, re-
gardless of the method of applica-
tion used.
1ABAAAA
Keaatodes
5-10 Ib/A Plant ero
(3 Ib/gal EC) apecific
mi
doi
Soil treatMent. Apply
osage in 50 to 250 gallons
per acre as a broadcast apray. Be-
gin application 1 to 3 Months after
planting. Make additional applica-
tions at intervals of 3 to 6 Months
as needed. (Mote: A preplant aoil
application of fenaaiphos 15 percent
granular, or a aoil fuaigant applied
according to label directions,
should be Made in addition to post-
plant broadcast applications of fen-
aaiphos.) Katoon cropt Soil treat-
Ment. Apply apecific dosage in 50
to 250 gallons per acre as a broad-
lasued: 4-14-86
XII-100601-6
-------
129
EPA Index to Pesticide Chemicals
ETHYL 3-METHYL-4-(HETHYLTHIO)PHENTL l-(METHYLETHYL)
PHOSPHORAMIDATE (9CA)
Site and Pest
Dosages and Tolerance, Pie, Limitation*
Pornulation(s)
Pineapple (continued)
/28015AA
Peanuta
4UBAAAA
Kematodea
cast apray. MaVe firat applications
immediately following crop harvest.
Make additional applications at in-
tervals of 3 to 6 tenths as needed.
0.02 ppe (peanuta) ' •
0.4 ppn (peanut hulls)
when band applications are used on
narrow row crops, do not use band
• widths that vill allow treated areas
to overlap.
1.65-2.8 at/ Preplant aoil treatment. land ap-
1,000 ft of plication. Apply apecific dosage
row in front of the planter ahoe as a
or 12 to 18 inch band. Incorporate the
1.5-2.55 Ib/A granules into the aoil to a depth
on 36 in. of 2 to 6 inches. Use the higher
row rates in fields with high popula-
(10Z. 151 C) tions of nematodea or in fields
003125-00237 having a history of aerious nema-
(3 Ib/gal EC) tode damage.
003125-00283
3.0-5.1 Ib/A Preplant aoil treatment. Broadcast
(101, 152 G) application. Distribute the gran-
(3 Ib/gal EC) ules of apray uniformly over the en-
tire area to be treated and thor-
oughly incorporate. Use the higher
rates in fields with high popula-
tions of neiuatodes or in fields
having a history of aerious nematode
damage. Plant crop in the usual
manner.
laaued: 4-14-86
III-100601-7
-------
130
EPA Index to Pesticide Chemicals
EXUXL 3-METHIL-4-(M£THTLTEIO)PHENTL 1-QfETRTLETBTL)
JHOSFBORAMZDATE (9CA)
/01006AA
Site and Pest
Baspberry
•ABAAAA
Rematodes
Doaages and Tolerance. Use. Limitations
Formulation(s)
0.1 ppm
For all araaa azcept CA.
Do not apply within 6 •oaths *f nsr-
Teat. Do not apply more than twice
per year.
6-12 Ib/A Soil treatment. Broadcast applies-
(3 Ib/gal EC) tion. Apply •pacific dosage per
003125-00283 act* as a broadcast frpray to estab-
llsbad planting* during the period
October 1 to December 31 when ade-
.- .• quate rainfall can be expected. Ap-
ply in sufficient water to insure
uniform distribution (15 to 100 gal-
lons of spray mixture per acre).
Direct epray to the aoil aurface and
the base of the plant. Dae the high
rate in fields with high populations
of nematodes or in fields having a
history of aerioua nematode damage.
/28023AA
f
Soybeans
(for all areas except CA)
0.05
When band applications are used on
narrow row crops, do not use band
widths that will allow treated areas
to overlap.
•ABAAAA
Bematodes
1.19-3.3 oc/
1.000 ft of
row
or
1.1-3.0 Ib/A
on 36 in.
row
(101, 15X C)
Freplant aoil treatnent. Band ap-
plication. Apply specific dosage
in front of the planter shoe as a
•pray or granular application on a
12 to 18 inch band. Incorporate the
product into the aoil to a depth of
2 to 6 inches. Use the higher rates
in fields with high populations of
003125-00237 mematodea or in fields having a hia-
(3 Ib/gal EC) tory of serious nematode damage.
003125-00283
4.0-6.0 Ib/A Freplant aoil treatment. Broadcast
(10Z, 15Z G) application. Distribute the gran-
(3 Ib/gal EC) ules or apray uniformly over the en-
tire area to be treated and thor-
oughly incorporate. Uae the higher
rates in fields with high popula-
tions of nematodes or in fields
having a history of serious nematode
Issued: A-U-86
III-100601-8
-------
131
EPA Index to Pesticide Chemicals
ETHYL 3-METHYL-4-(MrrHYLTHIO)PHEMYL l-(HETHTLETHYL)
PHOSPHORAMIDATE (9CA)
Site and Pest Possges and Tolerance. Use, Limitations
" Pormulation(s)
Sovbeans (continued)
damage. Plant crop in the usual
manner.
(for uae in CA only) -1ften band applications are used on
narrow rov crops, do not use band
widths that will allow treated areas
to overlap.
1ABAAAA Kemstodes 1.0-4.12 ot/ Preplant eoil treatment, land ap-
1,000 ft of plication. Apply specific dosage
row in front of the planter shoe as a
or •pray or granular application on a
0.9-3.75 Ib/A 12 to 16 inch band. Incorporate the
on 36 in. product into the soil to a dpeth of
row 2 to 6 inches. Use the higher rates
(152 C) in fields with high populations of
(3 Ib/gal EC) aematodea or in fields baring a his-
tory of serious ncmatode damage.
4.0-6.0 Ib/A Preplant soil treatment. Broadcast
(15Z G) application. Distribute the gran-
(3 Ib/gal EC) ules or apray uniformly over the en-
tire area to be treated and thor-
oughly incorporate. Use the higher
rates in fields with high popula-
tions of nematodes or in fields
having a history of serious nematode
damage. Plant crop in the usual
amnner.
TERRESTRIAL 1ONFOOD CROP
(Agricultural Crops)
/0400IDA Apple (nonbe*riag/nursery stock)
/OS002DA Cherry (nonbtaring/nursery stock)
/05004DA Peach (nonbearing/nursery stock)
tefer to TERRESTRIAL POOD CROP. (Agricultural
Crops), Apple cluster, for use and limitation in-
formation.
Issued: 4-14-86 III-100601-9
-------
132
EPA Index to Pesticide Chemicals
ETHYL 3-METHYL-4-(METHYLTHIO)FIEHYL l-(METHYLETHYL)
PHOSPHORAMIDATE (9CA)
Site and Pest
Dosages and Tolerance, Pse, Limitations
Pornulation(a)
/02000DA
/28038DA
/01014DA
•ABAAAA
Citrus (nonbearing/nuraery stock)
Fruit Trees (nonbearing/nuraery
Apply to trees that will not bear.
fruit within 12 Months after appli-
cation. Do not apply more than once
per plantinf aite per year.
Reaatodes
(SLN] SUT - Use limited to CA.
9-18 Ib/A Soil treatment. Apply specific doa-
(151 C) age per treated acre over the entire
(3 Ib/gal EC) area as a broadcast treatment using
%- ground injection equipment to place
the material 2 inches below the aoil
•urfaee. For band, apply as above,
proportionately to the band width
(a minimum of 50 percent of the row
width). Incorporate thoroughly by
sprinkler irrigation.
Crapes (nonbesring/nursery stock)
Apply to vines that will not bear
fruit within 12 months after the
application.
Kefer to Citrus (nonbearing/nursery atock) cluater
for use and limitation information.
/03000DA
Hut Trees (nonbearing/nuraery
atock)
H.F.
Apply to trees that will not bear
fruit within 12 months after appli-
cation. Do not apply more than once
per planting aite per year.
HAJAAAA
Nenatodes
(SLN] SLR - Use limited to CA.
9-18 Ib/A Soil treatment. Apply apecific dos-
(15Z C) age per treated acre over the entire
(3 Ib/gal EC) area aa a broadcaat treatment using
ground injection equipment to place
the material 2 inches below the aoil
aurface. For band, apply as above,
proportionately to the band width
(a minimum of 50 percent of the row
width). Incorporate thoroughly by
aprinkier irrigation.
lasued: 4-14-86
111-100601-10
-------
133
EPA Index to Pesticide Chemical*
ETHYL 3-METHYL-4-(METHYLTHIO)PHEim. l-(METHYLETHYL)
PBOSPROftAMIDATE (9CA)
Site and Pest
Dosages and Tolerance, Pie. Limitations
Pornulation(s)
/04003PA
Pears (nonbearing/nursery stock) II.P.
•ABAAAA
Neastodes
26003AA Tobacco
•ABAAAA
Hematodea
WEOBCAA
toot-knot nematode
Apply to trees that will not bear
fruit vithin 12 months after appli-
cation. Do not apply sjore than 20
pounds per planting aite per year.
[SLN] SIX - Use limited to OR.
10-20 Ib/A Soil treatment. Apply specific dos-
(15Z C) age per treated acre over the entire
(3 Ib/gal EC) area as a broadcast treatment or
proportionately to a 4 to 6 foot
'* • band ever the orchard rov. Incorpo-
rate thoroughly by apriakler irriga-
tion.
H.P.
Hot for use on ahadegrovn tobacco.
4.0-6.0 Ib/A Freplant toil treatment. Broadcast
(15Z C) application. Distribute the gran-
003125-00236 ules or epray uniformly over the en-
(3 Ib/gal EC) tire area to be treated smd i&corpo-
003125-00283 rate to a depth of 2 to 4 inches by
disking or tilling to ins-ore uniform
distribution. (Use a minimum of 20
gallons per acre for the eaulsifi-
able concentrate formulation.) Use
the higher rates in fields with high
populations of nemstodes or in
fields having a history of aerious
nematode damage. Plant crop in the
usual manner.
(SLR) SLN - Dae limited to GA. MD, «C. EC,
2.0-3.0 Ib/A and VA.
(2 Ib/gal EC) At planting aoil treatment. Dilute
1 gallon of the product in 10 to 50
gallons of water and apply uniformly
to the area to be treated. Dae the
higher rate in fields with high
populations of nematodes or in
fields having a history of aerious
nematode damage. Bed-up over the
row and plant crop in the usual
manner.
Formulated with 0.0-4iethyl 0-(P-
(methylsulfinyl)phenyl phosphoro-
thioate.
Issued: 4-14-86
111-100601-11
-------
134
EPA Index to Pesticide Chemicals
ETHYL 3-METHYL-4-(METHTLTHIO)PHENYL l-(METHYLETHYL)
PROSPRORAMIDATE (9CA)
Site and Pest
Tobacco (continued)
Possjes and Tolerance, Use, Limitation*
Pornulation(s)
May be tank mixed with metalaxyl and
several herbicides. Tank mixing is
not approved for KD and VA has ap-
proved tank mixing for metalaxyl
only.
tSLH]
2.0-3.0 Ib/A
<5X C)
VEFBBBB
Tobacco cyst nema-
tode
SLR - Use limited to GA, MD, SC, and
VA.
At planting soil application. Apply
uniformly to the area to be treated.
Use the higher rate in fields with
high populations of nematodes or in
fields having a history of serious
oouttode damage. Bed-up over the
rov and plant crop in the usual
manner.
Formulated with 0,0-diethyl 0-(P-
(methylsulfinyl)phenyl phosphoro-
thioate.
[SLN] SIX - Use limited to TA.
2.0-3.0 Ib/A At planting aoil treatment. Dilute
(2 Ib/gal EC) 1 gallon of the product in 10 to 50
gallons of water and apply uniformly
to the area to be treated. Use the
higher rate in fields with high
populations of nematodes or in
fields having a history of aerious
ncmatode damage, ted-up over the
row and plant crop in the usual
manner.
Formulated with 0,0-diethyl 0-(P-
(methylsulfinyDpheoyl phosphoro-
thioate.
Kay b« tank mixed with metalaxyl.
lasued: 4-16-86
111-100601-12
-------
/31021AA
•ABAAAA
|T31069AA
V34022AA
IT34031AA
|T34042AA
/34039AA
/34053AA
/34058AA
/35056AA
/35055AA
734063AA
734069AA
734070AA
731126AA
734078AA
/35073M
/31128AA
/34106AA
/33103AA
/35098AA
/34118AA
734120AA
/33125AA
/35116AA
/34137AA
/35130AA
/34143AA
RABAAAA
135
IPA Index to Pesticide Chemicals
ETHYL 3-METHTL-4-(METHTLTH10)PHENYL l-dffTHTLFTHYL)
nOSPHORAKXDATE (9CA)
Site and Pett
Dossies and Tolerance. Pse. Limitations
PormulationCa)
(Ornamental Plant* and Perest Trees)
Anthuriun
It emit odes
Do not apply more than twice during
any 12 Booth period.
1.9-3.4 ec/ Apply uniformly to the area to be
1,000 aq.ft treated and irrigate, immediately
or with a minima of 0.5 inch of water.
3.1-10.5 Ib/A
(10Z C)
OOU25-00237
Ajuts, 'Hetalliea* (nuraery atoek)
Atales (nursery atoek)
Boxvood (nuraery atock)
Cacti (nursery atoek)
Clematis (nuraery atoek)
Cotoneaster (nursery atock)
English fry. 'Baltic* (nursery
atock)
luonymus (nursery atock)
Pirethorn (nuraery atoek)
flowering Crab (nuraery atoek)
flowering Cherry (nuraery atoek)
Ca rd en ia (nursery atock)
hibiscus' (nursery atoek)
Holly (nuraery atock)
Iris (nursery atoek)
Japanese Andromeda (nuraery atoek)
Juniper (nuraery atock)
Plantain-Lily. 'Crandiflors'
(nursery atoek)
Paehysandra (nuraery atock)
Periwinkie"(nuraery atoek)
Pine (nursery atoek)
fchododendron (nuraery atoek)
Kose (nursery atock)
Sedum (nuraery atoek)
Spruce (nuraery atoek)
Viburnum (nursery atock)
Yevs (nursery atoek)
Tueea (nuraery atoek)
Do not apply more than once per year
per planting aite. le-entry inter-
val ia 48 hours unless impervious
boots and gloves are worn. In addi-
tion for a 7 day period following
completion of an application, imper-
vious gloves and boots must be worn
when entering treated fields that
are muddy.
Kemstodea
Issued: 4-14-86
18.0 Ib/A foil application. Apply uniformly
(102 C) to the area to be treated. Irrigate
003125-00237 imvediately after treatment using a
minimum of 0.5 inch of water. If
auraery atoek other than those list-
*
111-100601-13
-------
136
EPA Index to Pesticide Chemicals
«
ETHYL 3-METHTL-4-(MEi'HJLTEIO)THEN!L 1-(METHYLETHYL)
PHOSPBORAHIDATE (9CA)
Site and Pest Dosages and Tolersnee. Dse, Limitations
Formulatlen(s)
AJugs. 'Metallic*' (nursery stock) (continued)
•d are to be treated, treat a few
plants first and observe for phyto-
toxic ity before treating en a large
scale.
/33016AA lenttrass
/33017AA »eraudagrass For mse only en golf courses, eeme-
/33019AA frluegrassterles, mod farms, industrial
/33023AA Centipedegrass . grounds, parkways, and roadways.
.• . Do met use en residential lavns or
public recreational areas etber than
golf courses. Do mot apply more
than twice per year. Do not treat
newly seeded areas until the plants
have developed secondary roots.
VABAAAA Kematodes 0.233-0.467 gell application. Apply uniformly
lb/1,000 to the area to be treated and irri-
•q.ft gate immediately using a minimum of
or 0.5 inch of water,
10-20 Ib/A
/ CIO C)
003125-00237
/31126AA Iris (bulbs)
/31131AA Lily (bulbs) Bulbs may vary as to their phyto-
/31142AA Narcissus (bulbs) toxic sensitivity to fenamlphos.
Test a small number of plants if
this sensitivity is mot locally
known. Do not apply to green foli-
ate.
KABAAAA Hematodes 6.0-12.0 Ib/A Soil application. Apply at planting
er time so that the material is incor-
0.475-0.95 porated into the covering soil or
lb/100 ft - in a 10 to 12 inch hand over the row
of row after planting.
(101 6) For year old plantIns, apply over
003125-00237 the row as a fall application (Octo-
ber through December). Incorporate
with irrigation er rain water as
soon as possible after application.
Issued: 4-14-86 III-1006QL-14
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137
IPA Index to Pesticide Chemicals
ETHYL 3-«THYL-4-(METHYLTHIO)PHENYL l-(METHYLrrHYL)
PBOSPHORAMIDATE (9CA)
Site and Peit Po»«gei and Tolerance. Use, Limitations
F"ormulatien(s)
/39010AA Lestherleaf Fern
•ABAAAA Reaatodes 10.0 Ib/A Soil application. Apply uniformly
(10X C) to the area to be treated and irri-
003125-00237 gate immediately with • minimum of
•0.5 inch water.
/31005AA Ornamental Flower Bulba
Use limited to CA.
One application and 12 pounds per
/ year maximum.
i
fcABAAAA Remstodes [SIR] Soil application. Apply at planting
1 12.0 Ib/A time, ao that the material is incor-
(15Z C) porated into the covering toil or
(3 Ib/gal 1C) in a 10 to 12 inch band over the rov
after planting.
./34005DA Ornamental woody Vines (nursery)
/35000DA Ornamental Treei (nursery) Do not apply more than once per
" ' planting aite per year.
BABAAAA ; Hevstodes [SLR] SLR - Use limited to CA.
9-18 Ib/A Soil treatment. Apply apecific dos~
(1SZ G) . age per treated acre over the entire
(3 Ib/gal 1C) area as a broadcast treatment using
ground injection equipment to place
the material 2 inches below the aoil
surface. For band, apply as above,
proportionately to the band width
(a minimum of 50 percent of the row
vidth). Incorporate thoroughly by
aprinkier irrigation.
/34468AA Protea
Do not apply more than twice per
planting aite per year.
RABAAAA Reaatodes ISLR] SLR - Use limited to HI.
0.1-0.225 lb/ Postplant aoil treatment. Apply
1,000 sq.ft apecific dosage per unit area and
or incorporate mechanically into upper
4.5-9.75 Ib/A 2 to 3 inches of aoil, then irrigate
(151 C) immediately using • minimum of 0.5
inch of water.
Issued: 4-14-66 111-100601-15
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T58
EPA Index Co Pesticide Cheoical*
ETHYL 3-METHYL-4-(«THTLTHIO)PHENYL l-(METHYLETHYL)
nOSPBORAMIDATE (9CA)
Site and Pett POM get and Tolerance, P>e, limitations
PoraulatioTiCt)
AERIAL AND TAKE MIX APPLICATIONS
§900300 Tank Mix
AAAAAAA
— lefer to
TERRESTRIAL MOHTOOD CHOP
(Agricultural Crops)
Apple (noab««ring/nursery stock)
(SLR], Cherry (aonbearing/nurvery
•tock) (SIM], .Peach (aonbearinf/
- Buraery'ttoek) (SLH], Tobacco ISLU]
Isaued: 4-14-86 IIX-100601-16
-------
4065.0001
139
EPA Index to Pesticide Chemical*
ETHYL 3-METHYL-4-(HETHYLTHIO)PH£NYL 1-(METHYLETHYL)
PBOSPBCRAHIDATE (9CA)
Listing of legistered Pesticide Products by Formulation
85% technical chemical
ethyl 3-methyl-4-(methylthio)phenyl l-(««thylethyl) phospboramidate
(9CA) (100601)
003123-00269
4072.3002 72.31 formulation Intermediate
•005.0004
4015.0004
1202.0012
4203.0012
ethyl 3-methyl-4-(methylthlo)phenyl l-(methylethyl) phosphor amidate
(9CA) (100601)
003125-00333
SI granular
ethyl 3-methyl-4-(methylthio)phenyl l-(methylethyl) pbosphoramidate
(9CA) (100601) plus 0,0-diethyl 0>(P-(m«thylsnlflnyl)pheayl phosphoro-
thioate (032701)
GA790003 SC790008 TA790003
•016.0004 101
ethyl 3-m*thyl-4-(methylthio)phetjyl l-(methyletbyl) pbosphoraaldate
(9CA) (100601)
003125-00237
151 granular
•thyl 3-methyl-4-(«ethylthlo)phenyl l-<«*thylethyl) pbospboreaidate
(9CA) (100601)
003125-00236
AL820011
CA830062
GA780014
KT790002
ME780001
M07S0009
VT780002
01800064
IC790005
TX790036
HAM0055
AK800005
CE780015
CA800015
LA800003
W 17 7001 8
KS800006
VT810008
OK840034
SC800018
VT790008
WV780001
CA790185
FL780026
BI7 70002
LAS10015
KI770019
•C780002
OK780008
PA770012
TK780004
VA760033
CAB 2 001 2
CA780001
IK790002
KD790006
M0780008
W790020
01790072
SC780001
TK800007
VA790032
2 Ib/gal (ni) eamlsifiable concentrate
ethyl 3-»ethyl-4-(««thylthio)phenyl l-(methylethyl) phosphoraaddate
(9CA) (100601) plus 0,0-dltthyl 0-(P-(aethyl*ulfinyl)phcnyl phosphoro-
thioate (032701)
GA790002 KD820003 HC780036 SC790007
VA790003
3 Ih/gal (351) eaulslfiahle concentrate
ethyl 3-«tthyl-3^methylthio)ph«nyl
(9CA)"
tthylethyl) phosphor amidate
003115-00283
Issutd: 4-14-66
111-100601-17
-------
MO
EPA Index to P«tticide Chevicals
ETWL 3-METHYL-4-(METHYLTHIO)PHEHYL l-(METHYLETm)
PBOSPHORAHZDATE (9CA)
Lifting of Registered Pesticide Products by Formulation (continued)
3 Ib/gsl (351) eaulsifiable concentrate (continued)
AL820012 A1600004 CA790185 CAB20011
CA820101 CA830061 DE780014 FL780025
CA780011 CA780023 CA800016 CA840008
IL820003 IN790003 KT790001 LA800004
LA810014 MD790007 MD82000S ME780002
MS800007 HC780019 IM790021 HY780001
VT810007 OR810019 OIT780007 01790071
OK800063 01840035 PA770013 SC780009
SC790004 SC80001? TR800008 TZ79003S
UT780035 TA780003 VA780004 VA780010
KA760034 VA790033 WA840056 W780002
t
I
•
9999999 State Label Registration
•
• El leg. No.
" 037843-08571
Issued: 4-14-86 111-100601-18
-------
141
EPA Index to Pesticide Chemical*
ETHYL 3-Mrrm-4-(METHYLTHIO)FHEKYL l-(METHYLETHYL)
PBOSPHORAMIDATE (9CA)
Appendix A-l
Lilting of Active Xngredient(s) Found in Combination With the Itport Chemictl
Cheicietl Coanon W«ae EPA Acceptable
Code(source) Coaoon/Chemical V
032701 — 0,0-diethyl 0-(P-(«ethyl«ulfinyDphenyl
phocphorotbiomte
— Use CPA Acceptable CooBon/Chemical Have
laaued: 4-14-B6 111-100601-19
-------
142
EPA Index to Pesticide Chemicals
ETHYL 3-METHTL-4-(METHYLTHIO)PHElCYL l-(KETHYLETHVL)
PBOSPBOBAMIDATE (9CA)
Appendix A-2
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Cheaicsl Conaon Wane EPA Acceptable
Code (source)
SKtalaxyl
— Use EPA Acceptable Coaaon/Cheaical laae
Issued: 4-14-86 111-100601-20
-------
EPA Index to Pesticide Chemicals
3-hsinzi.-4—(nETHZi.TEIO)rofcifTL 1—(ncinii^XHii.)
FBOSPBOtAMXDATE (9CA)
auxiliary Documentation
There is a section 3 10Z granular registration (#003125—00237, stamp dated
Dec. 19, 1983), which is for non-bearing fruit (deciduous fruit trees, in-
cluding apples, cherries and peaches). It restricts the use of any fruit
forming on trees until one year after treatment. Likewise there are SLK
(special local meed, 24C registration) registrations, 30 in all, of a
similar mature. These are as follows:
1ST granulart DE78001500 XV79000200 LABI001400 MD79000600
KE78000100 MI77001900 BT78000200 -VT81000800
. 0178007200 PA77001200 VT79000800 VA78000300
VA78003200 9778000100
•
3 lb/tsl EC: DZ78001400 XL82000300 XB79000300 LABI001400
KD78000700 KE78000200 M77001800 WT78000100
•T81000700 OBSl001900 Ot79000700 PA77001300
UT79000700 TA78001000 VA78003300 W78000200
There is, however, a section 3 (101 granular) registration label (stamp
dated July 22, 1983) which is for fruit crop (including apples, cherries
and peaches) which has a FBI (pre-harvest interval) of 72 day for bearing
apples end 45 days for bearing cherries and peaches. There are also other
section 3 registrations for feaamlphos (a 15X granular bearing stamp dated
Kay 6, 1985 and a 3 pound per gallon EC bearing stamp date July 25, 1985)
which are for bearing apples, cherries and peaches having FBI's of 72 and
45 days respectively. Xt is my judgement (Mr. E*nry Jaeoby, FM 21 team
leader also agrees) that the accepted registrations on bearing fruit trees
(apples, cherries and peaches) with FBI's of 72 and 45 days, lift or coun-
termand the one year FBI restriction on the non-bearing deciduous fruit
trees. The index entry for fenamiphos has been written to reflect this
decision.
Vote: Since there ere mow section 3 registrations to cover all the SLR
registrations listed shove, it seems that it would be a prudent action to
get these off our books.
Signed:
J. Dean Bansen
Plant Pathologist
Issued: 4-14-86
ZXI-100601-m
-------
144
EPA Index to Pesticide Cheaicale
ETHYL 3-HKTHJL-4-(KETHYLTHIO)rHtwiL 1— (METBYLETBYL)
FBOSPBOtiHZDin (9CA)
Append iz A-2
Lie ting of Active Incredient(s) Which May Be Included IB Task Mixes
Chemical Comeo Haae EPA Acceptable
Code (aource) Coenon/ Chemical "Saae
113501 Betalaxrl »-(2,fr-t!i»ethylph«Byl)-R-(»«thor7«cetyl)-
alanlne» •ethyl eeter
- Dee EPA Acceptable Cowon/Chemical Baae
Xaeued: 4-14-86 ZII-1006Q1-20
-------
APPENDIX IV
BIBLIOGRAPHY
-------
145
BIBGUIDE-l
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
In the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those Instances where they have
been considered, will be Included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. .IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
1 MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to Identify volumes of submitted
studies; see paragraph 4(d)(J|) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number Is
also to be used whenever specific reference Is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
146
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, ithe Agency has chosen to show a personal author.
When no Individual was Identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took It directly
from the document. When a four-digit date Is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??)* the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial Insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
*•• final element in the trailing parentheses
identifies the EPA accession number of the volume
In which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123^56, the
first study would be 123456-A; the second, 123*56-
B; the 26th, 123^56-Z; and the 27th, 123U56-AA.
-------
T47
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
MRID CITATION
00025103 Wakefleld, M.; Orme, J.P.R.; MulUn, L.W.; et al. (1973) Determina-
tion of Residues of Nemacur and Its Metabolites 1n Bananas: Re-
port No. 36283. Rev. (Unpublished study received Dec 31, 1979
under HI 79/11; prepared by Huntingdon Research Centre, submit-
ted by state of Hawaii for Mobay Chemical Corp., Kansas City,
Mo.; CDL:241562-C)
00025112 Burrows, I.E.; Harwood, A.M.; Joyce, C.A. (1971) The Determination
of Bay 68138 (Nemacur) and Its Metabolites In Bananas: Report
No. 30164. (Unpublished study received Dec 31. 1979 under HI
79/11; prepared by Huntingdon Research Centre, submitted by
state of Hawaii for Mobay Chemical Corp., Kansas City, Mo.; CDL:
241563-G)
00025114 Burrows, I.E.; Way, D. (1971) Determination of Bay 68138 (Nemacur)
and Its Metabolites In Bananas: Report No. 30317. (Unpublished
study received Dec 31, 1979 under HI 79/11; prepared by Hunting-
don Research Centre, submitted by state of Hawaii for Mobay
Chemical Corp., Kansas City, Mo.; CDL:241563-I)
00025115 Olson, T.J. (1971) An Interference Study for the Nemacur Crop
Residue Method for Bananas: Report No. 31041. (Unpublished
study received Dec 31, 1979 under HI 79/11; prepared by Baychem
Corp., submitted by state of Hawaii for Mobay Chemical Corp.,
Kansas City, Mo.; CDL:241563-J)
00025958 Beavers. J.B.; F1nk, R.; Brown, R. (1977) Final Report: Eight-Day
Dietary LC50--Mallard Duck: Project No. 149-108. (Unpublished
study Including unofficial analytical report, received Mar 28,
1979 under 3125-236; prepared by Wildlife International, Ltd. 1n
cooperation with Washington College, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:237905-E)
00025959 Nelson, D.L.; Burke, M.A. (1977) Dietary Toxlclty of Nemacur
Technical to Bobwhlte Quail: Report No. 54042. (Unpublished
study received Mar 26, 1979 under 3125-236; submitted by Mobay
Chemical Corp., Kansas City. Mo.; CDL:237905-F)
00025960 Nelson. D.L.; Burke, M.A. (1977) Acute Toxlclty of Nemacur
Technical to Daphnla magna: Report No. 54047. (Unpublished
- study received Mar 28, 1979 under 3125-236; submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:237905-6)
00025962 Lamb, D.W.; Roney, D.J. (1977) Acute Toxlclty of Nemacur Tech-
nical, Nemacur Sulfoxide and Nemacur Sulfone to Blueglll: Report
No. 54150. (Unpublished study received Mar 28, 1979 under 3125-
236; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:
237905-1)
-------
148
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
MRID CITATION
00028849 Morris, R.A.; Olson, T.J. (1980) Synopsis of Nemacur Residue Chem-
istry on Grapes. (Unpublished study received Mar 4, 1980 under
3125-EX-173; prepared 1n cooperation with Chemonlcs Industries
and Morse Laboratories, Inc., submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:099304-A)
00029106 Mobay Chemical Corporation (1978) Addition to Synopsis of Nemacur
Residue Chemistry on Applies, Cherries and Peaches. (Unpub-
lished study received Feb 11, 1980 under 3125-236; CDL:099241-A)
00033831 Lamb, D.H.; Matzkanln, C.S. (1975) The Acute Oral Toxlclty of Nema-
cur Technical, Deslsopropyl Nemacur Sulfoxlde and Desethyl Nema-
cur: Report No. 44531. (Unpublished study received Jul 8, 1980
under 3125-236; submitted by Mobay Chemical Co., Kansas City,
Mo.; CDL:099496-C)
00035114 Bell, R.L.; Jacobs, K.; Gronberg, R.R. (1975) Nemacur Residues
1n Poultry and Eggs: Report No. 41,726. (Unpublished study re-
ceived Jul 8, 1980 under 3125-236; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:099497-H)
00036826 Chemago Corporation (1973) Chemagro Division of Baychem Corporation
Residue Experiment: 661-3942-72H; Report No. 35889. (Unpub-
lished study Including report nos. 35945, 35946, 35947..., re-
ceived May 23, 1973 under 3F1399; prepared 1n cooperation with
Analytical Biochemistry Laboratories; CDL:093747-C)
00036827 Analytical Biochemistry Laboratories (1973) Chemagro Division of
Baychem Corporation Residue Experiment: 261-3960-72H; Report
No. 35890. (Unpublished study Including report nos. 35891,
35892, 35893..., received May 23, 1973 under 3F1399; submitted
by Chemagro Corp., Kansas City. Mo.; COL:093747-D)
00036829 Chemagro Corporation (1973) Chemagro Division of Baychem Corpora-
tion Residue Experiment: KC-3947-72H; Report No. 35909. (Unpub-
lished study Including report nos. 35910, 35911, 35912..., re-
ceived May 23, 1973 under 3F1399; prepared 1n cooperation with
Analytical Biochemistry Laboratories; CDL-.093747-F)
00036830 Gronberg, R.R.; Simmons, C.E.; Shaw, H.R., II (1973) Residues of
Nemacur In Poultry Eggs and Tissue: Report No. 35995. (Un-
published study received May 23, 1973 under 3F1399; submitted by
Chemagro Corp., Kansas City, Mo.; CDL:093747-G)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
HRID CITATION
00036831 Khasawinah. A.M. (1973) Metabolism of Nemacur In Carrots: Re-
port No. 36005. (Unpublished study received May 23, 1973 under
3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:
093747-H)
00036837 Khasawinah, A.M. (1973) Metabolism of 14C-r1ng, 3H-Methylth1o
Nemacur In Snap Beans Grown in Closed Glass Chambers: Report
No. 36542. (Unpublished study received May 23, 1973 under
3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:
093747-N)
00036839 Chemagro Corporation (1970) The Effect of Frozen Storage at 0
to -10F on Nemacur Residues In Meat Tissues: Report*
No. 27083. (Unpublished study received May 23, 1973 under
3F1399; CDL:093744-B)
00036841 Chemagro Corporation (1970) Recovery of Bay 68138 from Oranges:
Report No. 27441. (Unpublished study received May 23, 1973
under 3F1399; CDL:093744-D)
00036842 Chemagro Corporation (1970) Residue Study: Bay 68138 on Navel
' Oranges: Report No. 27442. -{Unpublished study* received May 23,
1973 under 3F1399; CDL:093744-E)
00037962 Crawford, C.R.; Anderson, R.H. (1972) The Acute Dermal Toxlclty of
Nemacur Technical to Rabbits: Report No. 34216. (Unpub-
lished study received May 23, 1973 under 3F1399; submitted by
Chemagro Corp., Kansas City, Mo.; CDL:093741-A)
00037965 Loser, E. (1972) Bay 68 138: Chronic Toxlcologlcal Studies on Dogs
(Two-Year Feeding Experiment): Report No. 3561; Report
No. 34345. (Unpublished study received May 23, 1973 under
3F1399; prepared by Farbenfabrlken, AG, submitted by Chemagro
Corp., Kansas City, Mo.; CDL:093741-E)
00037979 Loser, E. (1972) Bay 68 138 Generation Studies on Rats: Report
No. 3424; Report No. 34029. (Unpublished study received May 23,
1973 under 3F1399; prepared by Farbenfabrlken Bayer, AG, submit-
ted by Chemagro Corp., Kansas City, Mo.; CDL:093742-M)
00038504 Chemagro Corporation (1971) Chemagro, a Division of Baychem Corpo-
ration, Residue Experiment: Report No. 31572. (Unpublished
study received May 23, 1973 under 3F1399; CDL:093745-A)
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150
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
HRID CITATION
00038506 Waggoner, T.B. (1972) Metabolism of Nemacur Ethyl 4-(methylth1o)-
m-toiyi Isopropylphosphoramidate and Identification of two
metabolites 1n plants. Journal of Agricultural and Food Chemis-
try 20(1):157-160. (Submitter report no. 32181; also 1n un-
published submission received May 23, 1973 under.3F1399; submit*
ted by Chemagro Corp., Kansas City, Mo.; COL:093745-C)
00038507 Chemagro Corporation (1972) Recovery of Nemacur from Soybeans:
Report No. 32929. (Unpublished study received May 23, 1973
under 3F1399; CDL:093745-D)
00038508 Chemagro Corporation (1972) Chemagro, Division of Baychem Corpora-
tion, Residue Experiment No. 509-3939-71H: Report No. 32930.
(Unpublished study Including report nos. 32931, 32932, 32933...,
received May 23, 1973 under 3F1399; CDL:093745-E)
00038509 Chemagro Corporation (1972) Chemagro, Division of Baychem Corpora-
tion, Residue Experiment No. 409-3911-71H: Report No. 32936.
(Unpublished study received May 23, 1973 under 3F1399; COL:
093745-F)
00038510 Chemagro Corporation (1972) Recovery of Nemacur from Citrus:
Report No. 33067. (Unpublished study received May 23, 1973
under 3F1399; CDU093745-G)
00038511 Chemagro Corporation (1972) Chemagro, Division of Baychem Corpora-
tion, Residue Experiment No. 409-3901-71H: Report No. 33075.
(Unpublished study Including report nos. 33076, 33077, 33078...,
received May 23, 1973 under 3F1399; CDL:093745-H)
00038522 Chemagro Corporation (1973) Chemagro Division of Baychem Corpora-
tion Residue Experiment 661-3951-72H: Report No. 35112. Rev.
(Unpublished study received May 23, 1973 under 3F1399; CDL:
093745-T)
00041022 Crawford, C.R.; Anderson, R.H. (1974) The Acute Oral Toxldty of
Two Nemacur Phenolic Metabolites and MTMC to Male and Fe-
male Rats: Report No. 39700. (Unpublished study received Oct
23, 1975 under 3125-236; submitted by Mob ay Chemical Corp.,
Kansas City, Mo.; CDL:096122-E)
00041023 Crawford, C.R.; Anderson, R.H. (1974) The Acute Oral Toxldty of
Nemacur-Sulfone and Nemacur-Sulfoxide to Rats: Report No.
40215. (Unpublished study received Oct 23, 1975 under
3125-236; submitted by Mobay Chemical Corp., Kansas City, Mo.,
CDL:096122-F) <
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151
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
MRID CITATION
00041025 Mobay Chemical Corporation (1975) Addition to Synopsis of Nemacur
Residue Chemistry on Various Crops. Summary of studies 096124-B
through 096124-G. Unpublished study received Oct 23, 1975 under
3125-236; CDL:096124-A)
00041027 Simmons, C.E.; Gronberg, R.R. (1975) The Fate of Carbon-14-Labeled
Nemacur and Nemacur Sulfoxide In Potatoes Processed by Pan
or French Frying: Report No. 43128. (Unpublished study received
Oct 23, 1975 under 3125-236; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:096124-D)
00041028 Puhl, R.J. (1975) The Effect of Processing on Nemacur and Me-
tabolite Residues 1n Sugar Beets: Report No. 43891. (Unpub-
lished study received Oct 23, 1975 under 3125-236; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:096124-E)
00041030 Simmons, C.E.; Thornton, J.S. (1975) The Fate of Carbon-14-Labeled
Nemacur Sulfoxide in Tomatoes Processed by Canning: Report
No. 44619. (Unpublished study received Oct 23, 1975 under 3125-
236; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:
I 096124-G)
00041206 Dow Chemical U.S.A. (1973) Seed and Pod Vegetables: Summary of Res-
idues In Soybeans, Field Beans, Green Beans, and Peas, and in
Forages of These Crops. (Unpublished study received Jan 17,
1974 under 1F1075; CDL:090832-B)
00045595 Khasawinah, A.M. (1972) Metabolism of Nemacur In Snap Beans
Grown in Closed Glass Chambers: Report No. 34992. (Unpublished
study received Aug 28, 1980 under 3125-236; submitted by Mobay
Chemical Corp., Kansas City. Mo.; CDL:243126-K)
00045605 Morse Laboratories, Incorporated (1978) The Effect of Frozen Stor-
age at 0 to -10F on Residues of Nemacur In Corn: Report
No. 66221. (Unpublished study received Aug 28, 1980 under
3125-236; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:243126-H)
00045612 Hanna, G.R.; Schermoly, M.J. (1980) Residues in Rotational Crops
following a Target Crop treated with Nemacur-ring-1,12,13,140
3 Formulation: Report No. 68575. (Unpublished study received
, Aug 28, 1980 under 3125-236; submitted by Mobay Chem-
ical Corp., Kansas City, Mo.; CDL:243126-AD)
00049668 Thornton, J.S. (1976) Effect of Processing on Residues of Nem-
acur In Oranges: Report No. 47003. (Unpublished study received
Sep 10, 1976 under 3125-236; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:095284-C)
-------
152
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamiphos Standard
MRID CITATION
00052494 Chemagro Corporation (1973) Supplement to Synopsis of Analytical
and Residue Information on Nemacur (Bay 68138) In Bananas.
Summary of study 093749-B. (Unpublished study received Hay 23,
1973 under 3F1399; CDL:093749-A)
00052495 Wakefleld, M.; Orme, J.P.R.; MulUn, L.W.; et al. (1973) Deter-
mlnation of Residues of Nemacur and Its Metabolites 1n Bananas:
FBA116/73220; Report No. 36283. Method dated Mar 21, 1973.
(Unpublished study received May 23, 1973 under 3F1399; prepared
by Huntingdon Research Centre, submitted by Chemagro Corp.,
Kansas City, Mo.; CDL:093749-B)
00052501 Chemagro Corporation (1974) Chemagro Corporation Residue Experi-
ment No. SE-3908-68H: Report No. 27032. (Unpublished study
received on unknown date under 3F1399; CDL:093748-G)
00052504 Khasawlnah, A.M. (1972) The Uptake and Metabolism of Nemacur
Soil Residues by Soybean Plants: Report No. 35012. (Unpublished
study received May 23, 1973 under 3F1399; submitted by Chemagro
Corp.. Kansas City, Mo.; CDL:093748-J)
($0052508 Analytical Biochemistry Laboratories, Incorporated (1974) Chemagro
Division of Baychem Corporation Residue Experiment: 161-3946-
72H: Report No. 36063. (Unpublished study received on unknown
date under 3F1399; submitted by Chemagro Corp., Kansas City,
Mo.; CDL:093748-Q)
00052509 Khasawlnah, A.M. (1973) Metabolism of "(R)tNemacur 1n Tomatoes: Re-
port No. 38501. (Unpublished study received on unknown date
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:093748-R)
00052510 Khasawlnah, A.M. (1973) The Metabolism of Nemacur 1n Cabbage:
Report No. 39120. (Unpublished study received on unknown date
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:093748-S)
00052511 Olson, T.J. (1974) The Effect of Alkali Refining on Nemacur
Residues 1n Cottonseed 011: Report No. 40113. (Unpublished
study received on unknown date under 3F1399; submitted by Chem-
agro Corp., Kansas City, Mo.; COL:093748-T)
00052518 Chemagro Corporation (19??) Summary Tables 6,7*8—Nemacur Residues
In Cotton Plants. (Unpublished study received May 23, 1973
under 3F1399; CDL:093743-G)
-------
153
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamiphos Standard
HRID CITATION
00052525 Thornton, J.S. (1970) A Gas Chromatographlc Method for the Deter-
mi nation of Bay 68138 and Metabolite Residues In Crops: Report
No. 25402. Includes method dated Aug 7. 1969. (Unpublished
study Including report nos. 25542. 26638, 27016..., received May
23, 1973 under 3F1399; submitted by Chemagro Corp., Kansas
City, Mo.; CDL:093743-Q)
00052526 Thornton, J.S. (1970) A Gas Chromatographlc Method for the Deter-
mination of Residues of Bay 68138 and Metabolites in Animal
Tissues and Milk: Report No. 25697. Includes method dated Sep
22, 1969. (Unpublished study Including report nos. 25744,
27011, 27012..., received May 23, 1973 under 3F1399; submitted
by Chemagro Corp., Kansas City, Mo.; CDL:093743-T)
00052527 Gronberg, R.R. (1969) The Metabolic Fate of...(Bay 68138),...(Bay
68138 Sulfoxide), and...(Bay 68138 Sulfone) by White Rats:
Report No. 26759. (Unpublished study received May 23, 1973
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:093743-U)
00055868 Mobay Chemical Corporation (1977) Addition to Synopsis of Nemacur:
Residue Chemistry on Various Crops. (Unpublished study received
Nov 19, 1979 under 3125-283; CDL-.241444-A)
00056049 Mobay Chemical Corporation (1976) Effect of Nemacur Residue
on Oranges and Lemons: Report No. 47140. (Compilation; unpub-
lished study Including report nos. 47141, 47142, 47143..., re-
ceived Sep 10, 1976 under 3125-236; CDL:095284-D)
00057606 Kimmerle, G. (1971) Nemacur P Acute Neurotoxiclty Studies on Hens:
Report No. 2829; Report No. 30772. (Unpublished study received
Mar 3, 1972 under 2E1251; prepared by Farbenfabrlken Bayer, AG,
West Germany, submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:091782-E)
00075270 Burrows, I.E.; Way, D. (1971) Determination of Bay 68138 (Nemacur)
and Its Metabolites In Bananas: Report No. 3990/71/148; Report
No. 30203. (Unpublished .study received 1974 under 4E1458; pre-
pared by Huntingdon Research Centre, England, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:093878-J)
00076988 Mobay Chemical Corporation (1981) Residue Data on Nemacur in
Grapes. (Compilation; unpublished study received Jun 1, 1981
under 3125-EX-173; CDL:245186-A)
-------
f54
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamiphos Standard
MRID CITATION
00078888 Mobay Chemical Corporation (1981) Nemacur Residues 1n Peanuts.
(Conp11at1on; unpublished study received May 4, 1981 under 3125-
236; CDL:244999-B)
00079270 Mcnamara, F.T.; Wilson, C.M. (1981) Behavior of Nemacur 1n
Buffered Aqueous Solutions: 68582. Rev. (Unpublished study re-
ceived Jul 23, 1981 under 3125-236; submitted by Mobay Chemical
Corp., Kansas City* Mo.; CDL:245613-A)
00079585 Pineapple Growers Association (1976) Supplement to Synopsis of Ne-
macur (Bay 68138) Residue Chemistry on Pineapple: Supplement
No. 3. (Compilation; unpublished study received 1976 under
38412-EX-136; CDL:229035-A)
00082111 Crawford, C.R.; Anderson, R.H. (1971) The Skin and Eye Irritating
Properties of Bay 68138 Technical to Rabbits: Report No. 29988.
(Unpublished study received May 5, 1971 under 1G1168; submitted
by Mobay Chemical Corp.. Kansas City. Mo.; CDL-.090966-0)
00082807 DuBols, K.P.; Flynn, M.; KinosMta, F. (1967) The Acute Toxlclty
and Antlchollnesterase Action of Bayer 68138: Submitter 20810.
f (Unpublished study received on unknown date under OF0982; pre-
pared by Univ. of Chicago, Toxlclty Laboratory, submitted by
Chemagro Corp., Kansas City, Mo.; CDL:098068-C)
00086981 Herbold, B.; Lorke, D. (1980) SRA 3886: Dominant Lethal Study on
Male Mouse To Test for Mutagenlc Effects: Report No. 8838;
69377. (Unpublished study received Nov 9, 1981 under 3125-237;
prepared by Bayer AG, West Germany, submitted by Mobay Chemical
Corp., Kansas City. Mo.; CDL:246210-A)
00087556 Interregional Research Project Number 4 (1981) Fenamiphos: Residue
Tolerance Petition—Rasberry. (Compilation; unpublished study,
Including published data, received Nov 17, 1981 under 2E2605;
CDL:070497-A)
00094220 U.S. Fish and Wildlife Service, Pesticide Field Station (1970) Bio-
assay Screening Test: Mobay 26522. (Unpublished study;
CDL:007178-E)
00094349 Khasawlnah, A.M. (1971) Metabolism of Nemacur Ethyl-4-
(methylthlo)-m tolyl 1 sopropy!phosphoramidate 1n Tobacco
Plants: Report No. 29142. (Unpublished study received Jul 13,
1977 under 3125-163; submitted by Mobay Chemical Corp.. Kansas
City. Mo.; CDL-.230934-B)
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155
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamiphos Standard
MRID CITATION
00098611 Mobay Chemical Corporation (1982) Addition to Synopsis of Nemacur
Residue Chemistry on Various Crops: Addition No. 10. Summary of
studies 070796-B through 070796-E. (Compilation; unpublished
study received Apr 22, 1982 under 6F1693; CDL:070796-A)
00098614 Hayes, R.H.; Lamb, D.W.; Mai11coat, D.R.; «t al. (1982) Technical
Fenamiphos (Nemacur) Oncogenlcity Study In Mice: 8037.
(Unpublished study received Apr 22, 1982 under 6F1693; submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:070797-A;
070798)
00101570 Mobay Chemical Corp. (1982) Nemacur Residue Chemistry on Various
Crops: Addition No. 11 (Carrots, Citrus) to the Brochure En-
titled: Nemacur: Analytical, Metabolic, Residue and Flavor
Information for Various Crops: Document No. AS 82-1290. (Com-
pilation; unpublished study received May 17, 1982 under 6F1770;
COL:070859-A)
00103094 Mobay Chemical Corp. (1981) Nemacur Residue Chemistry on Garlic:
, AS 82-1314. (Compilation; unpublished study received May 20,
' 1982 under 3125-263; CDL:070880-A)
00105945 Mobay Chemical Corp. (1982) Addition No. 2 to Brochure Entitled:
Nemacur Residue Chemistry on Grapes: AS 82-1688. (Compilation;
unpublished study received Jul 1, 1982 under 2F2723; COL:
070970-A)
00106037 Interregional Research Project No. 4 (1979) The Results of Tests
on the Amount of Fenamiphos Residues Remaining in or on Okra,
Including a Description of the Analytical Method Used. (Compi-
lation; unpublished study received Jul 12, 1982 under 2E2724;
CDL:070972-A)
00109257 Mobay Chemical Corp. (1982) Nemacur Residue Chemistry on Various
Crops: Addition No. 12 (Soybeans), Brochure No. 1112 to the Bro-
chure Entitled: Nemacur Analytical, Metabolic, Residue and Fla-
vor Information for Various Crops: AS 82-1815. (Compilation;
unpublished study received Jul 20, 1982 under 3125-236; CDL:
247894-A)
00112903 Mobay Chemical Corp. (1982) Nemacur Residue Chemistry on Apples,
Cherries and Peaches: Addition No. 2 to Brochure Entitled:
Nemacur Residue Chemistry on Apples, Cherries and Peaches:
AS 82-1999. (Compilation; unpublished study received Sep 1,
1982 under 3125-236; CDL:071065-A)
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156
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
MRID CITATION
00112904 Mobay Chemical Corp. (1982) Addition No. 3 to the Brochure En-
titled: Nemacur Residue Chemistry on Apples, Cherries and
Peaches: AS 82-2001. (Compilation; unpublished study received
Sep 1, 1982 under 3125-236; COL:071066-A)
00114012 Lamb, D.; Roney, D. (1972) Acute Tox1c1ty of Nemacur Technical and
Nemacur 15% Granular to Fish: Report Mo. 34014. (Unpublished
study received May 1, 1973 under unknown admin, no.; submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:120301-U)
00114015 Lamb, 0.; Roney, D. (1972) Acute Toxldty of Nemacur Sulfoxlde to
Blueglll: Report No. 35010. (Unpublished study received May 1,
1973 under unknown admin, no.; submitted by Mobay Chemical
Corp., Kansas City, MO; CDL:120301-AA)
00117403 Loser, E.; Klmmerle (1972) Bay 68138: Subchronlc Tox1colog1cal
Studies on Rats: Report No. 745; 23307. Rev. (Unpublished
study received on unknown date under 1G1168; prepared by Farben-
fabrlken Bayer AG, W. Ger., submitted by Mobay Chemical Corp.,
I Kansas City, MO; CDL:090967-D)
00117405 Mobay Chemical Corp. (1972) Amendment to Study 090968-A Entitled:
Nemacur (Bay 68138)—Analytical and Residue Information on
Pineapple (Jan 6, 1971). (Compilation; unpublished study re-
ceived on unknown date under 1G1168; CDL:090967-F)
00117406 Mobay Chemical Corp. (1971) Nemacur (Bay 68138): Analytical and
Residue Information on Pineapple. (Compilation; unpublished
study received May 6, 1971 under 1G1168; CDL:090968-A)
00117753 Mobay Chemical Corp. (1971) Nemacur (Bay 68138): Analytical, Resi-
due and Flavor Information on Tomatoes. (Compilation; unpub-
lished study received Jul 9, 1971 under 2G1179; CDL:090984-A)
00117754 Mobay Chemical Corp. (1971) Nemacur (Bay 68138): Analytical and
Residue Information on Cotton. (Compilation; unpublished study
received Jul 9, 1971 under 2G1179; COL:090985-A)
00118790 Mobay Chemical Corp. (1973) Nemacur Residues 1n Cauliflower, Broc-
coli, Potatoes, Cottonseed 011, and Various Crops. (Compila-
tion; unpublished study received May 23, 1973 under 3F1399; CDL:
093746-A)
00118794 Mobay Chemical Corp. (1976) Nemacur: Residue Chemistry on Apples,
Cherries and Peaches: Document No. AS76-1255. (Compilation;
unpublished study received Sep 10, 1976 under 3125-283; CDL:
095280-A)
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157
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenanriphos Standard
HRID CITATION
00119223 Mobay Chemical Corp. (1978) Nemacur: Residue Chemistry on Various
Crops: Document No. AS79-116. (Compilation; unpublished study
received Feb 8. 1979 under 3125-236; CDL:097788-A)
00119240 Mawdesley-Thomas, L. (1970) Pathology Report of Bay.68 138 Sub-
chronic Toxicological Studies in Rats: Submitter'23307a.
(Unpublished study received May 5, 1970 under unknown admin.
no.; prepared by Huntingdon Research Centre, Eng., submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:126894-B)
00121286 Mackenzie, K.; Dickie, S.; Mitchell, B.; et al. (1982) Teratology
Study with Nemacur in Rabbits: Study No. 81165; 82268. Final
rept. (Unpublished study received Dec 16, 1982 under 3125-283;
prepared In cooperation with Hazleton Raltech, Inc., submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:071290-B)
00121289 Lamb, D.; Carsel, M. (1982) Acute Oral LD50 of Nemacur Technical
to Bobwhite Quail: Study No. 81-015-02; 80372. (Unpublished
study received Dec 16, 1982 under 3125-283; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:071291-B)
00121290 Lamb, D.; Carsel, M.; Toll, P.; et al. (1982) Fenamiphos Repro-
duction Study with Mallard Duck: Study No. 81-675-01, 82225.
(Unpublished study received Dec 16, 1982 under 3125-283; sub-
mitted by Mobay Chemical Corp., Kansas City, MO; CDL-.071291-C)
00121291 Lamb, D.; Carsel, M.; Mall1coat, D.; et al. (1982) Fenamiphos
Reproduction Study with Bobwhite Quail: Study No. 80-675-03;
82224. (Unpublished study received Dec 16, 1982 under 3125-
283; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
071291-D)
00121865 Mobay Chemical Corp. (1982) Nemacur: Residue Chemistry on Pine-
apple: Addition No. 6 to the Brochure Entitled: Nemacur (Bay
68138): Analytical and Residue Information on Pineapple: Docu-
ment No. 82-R-2638. (Compilation; unpublished study received
Dec 16, 1982 under 3125-283; CDL:071288-A)
00121866 Mobay Chemical Corp. (1982) Nemacur: Residue Chemistry on Pine-
apple: Addition No. 5 to the Brochure Entitled: Nemacur (Bay
68183): Analtyleal and Residue Information on Pineapple: Docu-
ment No. 82-R-2637. (Compilation; unpublished study received
Dec 16, 1982 under 3125-283; CDL:071289-A)
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158
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamiphos Standard
MRID CITATION
00128729 Interregional Research Project No. 4 (1982) The Results of Tests
on the Amount of Fenanrtphos Residues Remaining 1n or on Aspara-
gus, Including a Description of the Analytical Method Used.
(Compilation; unpublished study received Jun 16, 1983 under
3E2913; CDL:071702-A)
00133402 Mobay Chemical Corp. (1983) Supplement No. 4 to Brochure Entitled:
Nemacur: The Effects on the Environment: Environmental Chemistry
(Dated February 1, 1973): Document No. AS 83-2611. (Compila-
tion; unpublished study received Dec 9, 1983 under 3125-236;
CDL:251891-A)
00133475 Mobay Chemical Corp. (1983) Ninety-day Chollnesterase Study on Rats
with Fenamiphos 1n Diet: Protocol for Study No. 83-171-01. (Un-
published study received Dec 9, 1983 under 6F1693; CDL:072226-B)
00134808 Mobay Chemical Corp. (1977) To Submit Efficacy Data (12.05) Sup-
porting Use on Citrus: Nemacur. (Compilation; unpublished
study received Aug 23, 1977 under 3125-236; COL:231387-A)
00134943 Mobay Chemical Corp. (1974) Supplement No. 1 to Brochure Entitled:
Nemacur (BAY 68138): Analytical and Residue Information on Pine-
apple Dated January 6, 1971: Document No. A576.1271. (Compila-
tion; unpublished study received Sep 10, 1976 under 3125-236;
CDL:095275-A)
00148464 Watanabe, M. (1983) Fenamiphos: Dermal Sensltization Study In the
Guinea Pigs: Report No. 252. Unpublished Mobay report 88736
prepared by Nihon Tokushu Noyaku Seizo K.K. 20 p.
00152195 Mobay Chemical Corp. (1985) [The Effect of Frozen Storage on Nema-
cur Residues In Several Crops; Nemacur Residue in Cabbages In-
cluding Revisions]. Unpublished compilation. 13 p.
00153468 Mobay Chemical Corp. (1985) [Residue Data of Fenamiphos on Garlic].
Unpublished compilation. 55 p.
00154492 Thyssen, J. (1979) SRA 3886 (Nemacur Active Ingredient) Acute Inha-
lational Toxiclty Studies: Report No.: 8210. Unpublished study
prepared by Bayer AG Institut fuer Toxikologie. 22 p.
00154493 Hayes, R. (1983) Ninety-day Chollnesterase Study on Dogs with Fe-
namiphos 1n Diet: Study Number 83-174-01. Unpublished study
prepared by Mobay Chemical Corporation. 43 p.
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159
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenamlphos Standard
MRID CITATION
00154497 Mi hail, F.; Schilde, B. (1980) SRA 3886 (Active Ingredient of Nema-
cur): Subacute Dermal Toxicity Study on Rabbits: 81-T-025. Un-
published study prepared by Bayer AG Instltut Fuer Toxlkologie.
83 p.
00154503 Mobay Chemical Corp. (1980) Nemacur Residue Chemistry on Various
Crops: Addition No. 7 (Soybeans). Unpublished compilation of
Mo bay Chemical Corp. 69 p.
00154528 Mobay Chemical Corp. (1982) [Residue Data of Nemacur on Several
Crops]. Unpublished compilation. 939 p.
Corp. 939 p.
00157805 Mobay Chemical Corp. (1985) Nemacur Residue Chemistry on Pineapple
Addition No. 7: Brochure No. 1385. Unpublished compilation.
110 p.
00159027 Yang, L.; Putrcan, D. (1985) CHO/HGPRT Mutation Assay 1n the Pre-
sence and Absence of Exogenous Metabolic Activation: Test Artl-
/ cle Nemacur: Final Report Amendment: MA Study No. T2600.332.
Unpublished study prepared by Microbiological Assoc., Inc.
25 p.
00161361 Hayes, R. (1986) Combined Chronic Tox1c1ty/0ncogen1c1ty Study of
Technical Fenamlphos (Nemacur) with Rats: Study No. 83-271-01:
Mobay Report No. 91750. Unpublished study prepared by Mobay
Chemical Corp. 1095 p.
00165546 Mobay Chemical Corp. (1381) Nemacur: Residue Chemistry on Cocoa
Beans. Unpublished compilation. 69 p.
40211201 Mobay Chemical Corp. (1974) Nemacur: Analytical, Metabolic,
Residue, and Flavor Information on Tobacco. Unpublished
compilation.
40220001 Mobay Chemical Corp. (1975) Nemacur (Bay 68138) Residue Chemistry
for Tobacco. Unpublished compilation.
-------
APPENDIX V
FORMS
-------
OMB Approval No. 2000-0468 (Expins 12-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With raspact to thi raquiramant to submit "sjamffc" data imposad by tha FIFRA action 3(C)(2)(B) notice containtd in thi rafwancad
Guidance Document, I am responding in thi following mannar
D1. I will submit dm in • tkndy minnir to satisfy thi following requirements. If the tast procedures I will tut deviate from (or art not
specified in) thi Registration Guidilirat or the ProtNOls conttimd in thi Rtports of Expirt Groups to thi Chimicili Group, OECD
Chemicals Tatting Programmi, I andosa thi protocols that I will MB:
O 2. I htvt mttrtd into an agmmant with orw or mori othir ragistrants undtr FIFRA stction 3(C)(2)(B)(ii) to atisfy thi following dati
raquiramantt. Thi ttsts, and any raquirad protocols, will ba submittid to EPA by:
NAME OF OTHER REGISTRANT
O3. I anclosi a complitid "Cartification of Attampt to Enttr Into an Agmmant with Othar Rigistrints for Otvilopmmt of Data" whh
rwpict to the following data raquiramants:
O 4. I raquast that you amind my ragistntion by dilating thi following ustt (thb option is not available to applicants for naw products):
D 6. I raquast voluntary cancttlation of thi registration of this product (This option is not availabli to applicants for naw products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form KM-I (1042)
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161
OMB Appronl No. 2000-0468 (Exoins: 12-31-83)
(To Qtafffy. certify ALL four hunt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(t) who arc subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
CPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, rf necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enttr into such an agreement Copies of the offers are attached. That offer was irrevocable end included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all tarms could not be reached otherwise. Tim offer wet mide
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 85104 (1042)
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162
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
S158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
/**
62-3
63-2
63-3
63-4
63-5
63-6
63-/
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
Ingredients
Preliminary
analysis
Certification of
Units
Analytical methods
for enforcement
limits
Color
Physical state
^>dor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
lest not
required
for my
product
listed
above
(check
below)
.
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data .
(At- '
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
1.63
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-10
63-19
. 63-20
63-21
$158.135
TOXICOLOGY
81-1
81-2
t"-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammablllty
Explodablllty
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxlclty, rat
Acute dermal
toxlcity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRJD
Number or
EPA. Accession
Number
Submit-
ting
Data
(At-
tached)
(Pbr EPA Use Only)
Accession Numbers
Assigned
-------
1 {.A CMB Approval No. 2070-0057
1 ° n Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of Intent to submit the generic data In question, on the grounds
that the product contains the active Ingredient solely as the result of the
Incorporation Into the product of another product which contains that active
ingredient, which is registered under PIFRA Section 3* and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Fbrmula(CSF) for the above-identified
product is attached to this statement. That formula statement Indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Pom No. 857(M. The
registered source(s) of the above named active Ingredient In my product(s) Is/are
and their registration number(s) is/are _____________ •
My firm will apply for an amendment to the registration prior to changing
the source of the active Ingredient in our product.
00 I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement Is no longer true, or if my firm falls to comply with
the undertakings made In this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fall to take appropriate steps to meet
requirements or are no longer In compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not In compliance and
will normally Initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, In such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: /
(Typed)
EPA Form 8570-27
-------
161
OMB Approvtl No. 200OC4S8 (Expires: 12-31-831
(To qutllfy, curtifvALL four fttrra)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who art cubject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firrm it referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
hems or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers art attached. That offer w« irrevocable and included en offer to be
bound by an arbitration decision under FIF RA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mede
to the following firm (si on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its regirtration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
f PA F»*m 85804 (1M2)
-------
161
OMB AppronlNo. 200OQ468 fExpires: 12-31-831
(To qualify. etrtlfvALL fouritfmt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of • Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
hams or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) K final agreement on all terms could not be reached otherwise. This offer wet made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the ragistration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its ragistration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 65804 (1042)
-------
1.63
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
- 63-20
63-21
S158.135
TOXICOLOGY
81-1
81-2
,"**
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flamnabllity
Explodabillty
Storage stability
Viscosity
Mlsclblllty
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxlclty, rat
Acute dermal
toxlcity, rabbit
Acute Inhalation,
toxicity, rat
Primary eye
irritation, rabbit
"Primary dermal
irritation
Dermal sensltlza-
tlon
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRJD
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
163
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
1
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Flanmability
Explodability
Storage stability
Viscosity
Miscibllity
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxlclty, rat
Acute dermal
toxiclty, rabbit
Acute inhalation,
toxicityj rat
Primary eye
Irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citlr« MRJD
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
------- |