vvEPA
EnvironmMital Protection
AQMICV
Off feM Of
PwttcfcJw and Toxic SubtUnoM
WaAington DC 20460
June 1988
540/RS-88-094
Guidance for the
Reregistration of
Pesticide Products
Conta.,.:ng FENTHION
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
FENTHION
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 55-38-9
OPP CHEMICAL NO. 053301
EPA CASE NUMBER GS0290
JUNE 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
I. Introduction 1
II. Chemical Covered by "his Standard 4
A. Description of Chemical 4
B. Use Profile 5
III. Agency Assessment 7
A. Introduction 7
B. Preliminary Health Risk Assessment 7
C. Ecological Effects 11
D. Environmental Profile 12
E. Tolerance Reassessment 14
IV. Regulatory Position and Rationale 16
A. Regulatory Position 16
B. Required Labeling 23
V. Products Subject to This Standard 32
VI. Requirement for Submission of Generic Data .... 35
A. What are generic data? 35
B. Who must submit generic data? 35
C. What generic data must be submitted? 36
D. How to comply with DCI requirements 36
E. Testing Protocols, Standards for Conducting
Acceptable Tests, Guidance on Evaluating
and Reporting Data 38
F. Procedures for requesting a change In
testing protocol 39
G. Procedures for requesting extensions
of time 39
H. PR Notice 86-5 and Any Other requirements
Referenced or Included Within this Notice . 40
I. Existing stocks provisions upon
suspension or cancellation * 40
VII. Requirement for Submission of Product-Specific
Data 42
VIII. Requirement for Submission of Revised Labeling . . 43
IX. Instructions for Submission 44
A. Manufacturing-Use Products (Sole Active) ... 44
B. Manufacturing-Use Products (Multiple Active) . 45
C. End-Use Products (Sole Active) 46
D. End-Use Products (Multiple Active) 46
E. Intrastate Products 47
F. Addresses 47
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APPENDICES
Page
I. DATA APPENDICES 48
Guide to Tables . 49
Table A 52
Table B 89
Table C N/A
II. LABELING APPENDICES 95
Summary of Label Requirements and Table 96
40 CFR 162.10 Labeling Requirements 106
Physical/Chemical Hazards Labeling Statements . . . 115
Storage Instructions 116
Pesticide Disposal Instructions 117
Container Disposal Instructions 118
IV. BIBLIOGRAPHY APPENDICES 119
Guide to Bibliography 120
Bibliography 123
V. FORMS APPENDICES 136
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet .... 137
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement With Other Registrants for
Development of Data 138
EPA Form 8580-4 Product-Specific Data Report 139
EPA Forn 8570-27 Generic Data Exemption Statement . . . 141
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GLOSSARY OF TERMS AND ABBREVIATIONS
EEC:
ADI: Acceptable Dally Intake
a.1.: active Ingredient
CAS: Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
Median Effective Concentration - the concentration of
substance producing a specific effect or response 1n
50 percent of the test organisms.
Estimated Environmental Concentration - an estimate of
the concentration of a pesticide occurring 1n or on
various media (I.e., soil, water, vegetation) after
pesticide application.
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodentlclde Act
Median Lethal Concentration - a statistically derived
concentration of a substance that can be expected to
cause death In 50% of test animals, expressed as weight
or volume of test substance per volume of air or water
or per weight of feed (e.g., mg/1 or ppm).
Median Lethal Dose - a statistically derived single
dose that can be expected to cause death 1n 50% of test
animals when administered by the route Indicated,
expressed as weight of substance per unit weight of
test animal (e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number) - EPA's system of
tracking studies used In support of registration.
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs of the U.S. EPA
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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 PIPRA. The standards are
applicable to reregistrat ion 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 FIPRA, 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
PIPRA. 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 man
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.
1The scientific reviews and use index are available from
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161 or from the Order Desk (703) 487-4650.
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EPA's reassessment results 1n the development of a
regulatory position, contained 1n 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).
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 tfce 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 sec. 3(c)(2)(B) to require that registrants submit data to
answer our questions regarding the chemical, toxlcologlcal, 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 1n the Tables A, B, and C. of 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.
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Registrants are reminded that F1FRA sec. 6(a)(2) requires
them to submit factual Information concerning possible
unreasonable adverse effects of a pesticide at any time that they
become aware of such Information. Registrants must notify the
Agency of any Information, Including Interim or preliminary
results of studies, If that Information suggests possible adverse
effects on man or the environment. Thi.> requirement 1s
Independent of the specific time requirements Imposed by EPA for
submission of completed studies called 1n by the Agency and
continues as long as the products are registered under FIFRA.
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II.
CHEMICAL COVERED BY THIS STANDARD
Standard:
A. Description of Chemical
The following chemical 1s covered by this Registration
Common Name: Fenthion
Chemical Name: 0,0-d1methyl-0-[4-(methylth1o)-m-tolyl J
phosphorothloate.
Other Chemical: 0.0-d1methyl-0-[3-methyl-4-(methy1th1o)
Names:
Trade Names
phenyl] phosphorothloate
0,0-dimethy1-0-4-methy1th1o-m-tolyl
phosphorothloate
Baytex; Entex; Bayer 29493;
Bayer S-1752; Baydd; Lebaycld;
Spotton; Tlguvon; Mercaptophos
Chemical Class: Organophosphate
Empirical Formula:
Molecular Weight: 278.3
Molecular Structure:
s
II
CAS Registry No.: 55-38-9
Ala Registry No.: 25-540
OPP Chemical No.: 053301
Year of Initial Registration: 1965
U.S. and Foreign Producers:
Mobay Chemical Corp
(Un1ted States); and
Bayer AG (Federal
Republic of Germany).
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Physical/chemical properties of fenthlon.2
Color: Yellow-tan
Physical State: Liquid
Odor: Slight garlic odor
Melting Point: <-25°C
Boiling Point: 105°C at 0.01 mm Hg
Density: 1.250 at 20°C
Solubility: Practically Insoluble 1n water
(55 mg/1), soluble 1n methanol,
ethanol, ether, acetone, and many
other organic solvents (especially
chlorinated hydrocarbons)
Vapor Pressure: 3 x 10~5 mm Hg at 20°C
Refractive Index: ND20 1.5698
Stability: Stable up to 210°C, resistant to
alkali up to pH 9.0
B. Use Profile
Fenthlon Is a contact and systemic organophosphate
1nsect1c1de/acarlcl de registered for mosquito and Insect
control on swamps, standing water, recreation areas, alfalfa,
pasture grass, forests, barns, poultry houses, nonfood areas of
commercial buildings and restaurants, and homes; for lice control
on cattle (beef and non-lactatlng dairy) and hogs; for control
of ants, mites, leafhoppers, and aphlds on ornamentals and
flowers; for bird control; and for use on rice to control
mosquitoes (In the State of California only).
Over half of the fenthlon used In the United States 1s
for mosquito control. A substantial portion of the remainder 1s
used for control of pests on cattle with lesser amounts used on
swine and bird control. Minor use sites Include pest control 1n
homes, buildings, food-handling establishments, ornamentals, and
forest tree.
2jhe physical/chemical properties of fenthlon listed 1n this
section were obtained from Merck Index, 10th Edition.
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Fenthion 1s marketed as 1% dust (D) formulations;
2, 4, 7, and 9.67 pound Ub) active 1ngr:»-i1ent (a1) per gallon
(gal) emulsiflable concentrate formulations (EC); 2, and 4,
Ib/gal soluble concentrate/liquid (SC/L) formulations; 1, 2,
and 5 percent granular (G) formulations; and liquid-ready to use
(L-RTU) formulations ranging from 0.5 to 20 percent active
Ingredient. Both ground and aerial applications are used to
control mosquitoes and control measures are directed to both the
aquatic (larval/pupal) stages and the free-flying adult stage.
There are 51 federally registered [FIFRA Section 3]
products (3 technical, and 48 end-use) and 20 Special Local Need
[FIFRA Section 24c)] registrations containing fenthlon as a
single active Ingredient. There are also 13 federally registered
end-use products (2 formulation Intermediates and 11 end-use)
containing fenthlon In combination with one or more other active
Ingredients. There are 6 Intrastate registrations containing
fenthlon as an active Ingredient.
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III. AGENCY ASSESSMENT
A. INTRODUCTION
The Agency's preparation of this Fenthlon
Registration Standard Included a review of all data submitted, In
support of the registration of fenthlon, through September 1986.J
At the conclusion of that review, the Agency Identified those
data still needed to fully evaluate the human, environmental, and
ecological risks associated with the use of fenthlon. Registrants
with products containing fenthlon must develop and submit those
data to the Agency 1n order to maintain their current registra-
tions or to register new products containing fenthlon. A summary
of those data gaps may be found 1n Appendix I of this document.
The Agency's assessment of the available data relating to human,
environmental, and ecological effects Is set forth below.
B. PRELIMINARY HEALTH RISK ASSESSMENT
1. Acute Toxlclty
Based on the results of acceptable acute
toxldty studies, fenthlon Is considered to be 1n toxlclty
Category II (moderately toxic) for acute oral toxlclty (rat 1050
= 295.6 +_ 17.2 mg/kg (females) and 250.2 +_ 8.6 mg/kg (males)),
acute dermal toxlclty (rat 1050 = 2830 mg/kg bw (females) and
1680 mg/kg bw (males)), and acute Inhalation toxlclty (rat LCso =
approximately 0.8 mg/llter (females) and 1.2 mg/Hter (males));
and Toxlclty Category IV (minimally toxic) for eye Irritation
(rabbit) and dermal Irritation (rabbit - primary Irritation Index
= 0.4). The dermal sensltlzatlon and acute delayed neurotoxldty
potential of fenthlon cannot be determined at this time.
2. Subchronlc Toxlclty
Two supplementary subchronlc feeding studies
for the dog and rat, and one supplementary subchronlc dermal
study for the rabbit were reviewed. In the dog subchronlc
feeding study significant Inhibition of serum chollnesterase In
the 5 and 50 ppm groups and markedly reduced erythrocyte cholln-
3Data submitted In response to the Agency's Data Call-In
Letter of April 29, 1986 were not received In time to be
Included in the data base reviewed for this Standard. Data
submitted In response to the April 29, 1986 Data Call-In are
currently 1n various stages of the Agency's review process. Due
dates for data still outstanding from the April 29. 1986 Data
Call-in are Indicated on the data requirement tables as specific
calendar dates. All data submitted In support of the
registration of fenthlon since September 1986 will be evaluated
when the Agency updates this Registration Standard.
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esterase activity 1n the 50 ppm group was reported. In a similar
study In rats, Inhibition of cholInesterase activity 1n boch the
males and females at the 25 and 100 ppm levels was reported. In
the rabbit subchronlc dermal study, New Zealand white rabbits
were dosed dermally with fenthlon on a dally basis for 3 weeks.
The study reported a plasma and red blood cell chollnesterase no
observed effect level (NOEL) of <5 mg/kg/day (the lowest dose
tested) and a systemic NOEL >25 mg/kg/day (the highest dose
tested). However, because these studies were unacceptable for
filling this data requirement, the submission of acceptable
subchronlc toxlclty studies Is required.
3. Chronic Toxlclty
Chronic feeding studies Involving the dog
and the rat were reviewed and are considered to be Inadequate.
In a chronic feeding study male and feaale Beagle dogs were fed
from 0 to 60 ppm fenthlon over two years. A chollnesterase
Inhibition NOEL of 3 ppm was reported. In a similar study 1n
Wistar rats the chollnesterase Inhibition NOEL was 3 ppm and the
systemic NOEL was 15 ppm. However, because these studies were
unacceptable for filling this da La requirement, the submission of
acceptable rodent and nonrodent studies 1s required.
4. Ocular Effects (Toxic Effects on the Eye)
Organophosphate pesticides, such as fenthlon,
have been observed to produce toxic effects on the eye.
Extensive human poisoning produced a syndrome of effects on
vision ranging In severity from myopia to congestion or atrophy
of the optic nerve. Studies on dogs and rats utilizing organo-
phosphate pesticides, Including fenthlon, duplicated the effects
observed 1n humans.
Based on this Information and the lack of
specific attention to the pathology of the eye 1n the available
studies, the Agency Is requiring the submission of special
studies, In rodent and nonrodent species, on the effects of
fenthlon on the eye.
5. Oncogenidty
At this time the Agency has classified
fenthlon as an "Inadequate evidence, Group D" carcinogen based on
the review of two supplementary oncogenlclty studies for the rat
and one supplementary oncogenlclty study for the mouse. In the
first rat study groups of 50 wale and 50 female Fisher 344 rats
were fed fenthlon 1n their diets at doses of 10 and 20 ppm for
103 weeks. Another group of 25 male and 25 female Fisher 344
rats were fed diets containing 0 ppm of fenthlon for 103 weeks.
This study provided Insufficient evidence for the oncogenic
potential of fenthlon because of the low doses used; the number
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of controls; and the lack of a demonstrated toxic response. In
the rat study groups of 50 male and 50 female SPF (Ml star strain)
rats were fed diets containing fenthlon at nominal doses of 3,
15, and 75 ppm, respectively, for 24 months. No oncogenlc effect
was evident 1n SPF (bMstar strain) rats 1n this 2-year dietary
study. However, there Is no assurance that the treated rats
actually consumed the Intended amounts of fenthlon,si nee no
Individual animal food consumption data were provided. There was
also no Indication that the feed mixtures were analyzed and
monitored on a scheduled basis for reprodudbll 1 ty and stability.
In the mouse oncogenlclty study 50 male and
50 female B6C3F1 mice were fed fenthlon In their diets at doses
of 10 and 20 ppm for 103 weeks. H1stopathol ogl c findings
revealed a higher Incidence of several types of sarcomas of the
skin and subcutaneous tissue In treated male B6C3F1 mice that
appeared to be associated with the administration of fenthlon and
suggested that fenthlon was oncogenlc 1n this sex and strain of
mice. However, this study provides Insufficient evidence for the
oncogenlc potential of fenthlon because of the low doses used;
the number of controls; and the lack of a measured toxic
response. No acceptable data are available on the oncogenlc
potential of fenthlon. Oncogenlclty studies are required 1n two
species.
6. Developmental Effects (Teratogenlclty)
The Agency reviewed teratology studies for
the rat and rabbit, but only the rabbit study was found to be
acceptable. Because of the deficiencies 1n the rat study, the
Agency 1s requiring the submission of a new acceptable
teratology study 1n a second species (preferably the rat) or
submission of the following Information to update the existing
rat study:
1) An English translation of the study "Machemer, L.
and E.G. Stenger. Zur Beurtellung der Foeten 1m
teratolloglschen Experiment. Modlflkatlon der "Hllson-
Teechnlk". Arznelm. Forsch. (Drug Reseach) 21:144-
145, 1971.";
2) An English translation of the dam and litter data
for the study; and
3) An English translation of the historical control
data for Incidences of malformations for the FB 30 rats
as supplied by Bayer AS, Zentralstelle fflr Versuch-
stlere.
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In the rabbit teratology study, female and
male Chinchilla hybrid rabbits were mated 1n a 1:1 ratio twice,
If possible, by the same male as soon as possible after the
Initial mating. Mated females were randomly assigned to 4 groups
of 20 each and were administered, orally by gavage from days 6
through 18 of gestation, the following doses of fenthlon:
vehicle control (0); 2, 6 and 18 mg/kg/bw respectively. In this
study the maternal toxldty NOEL was 6 mg/kg/day; the fetotoxlc
NOEL was 2 mg/kg/day; and the teratogenlc NOEL was >_18
mg/kg/day. The Agency concluded that fenthlon does not Induce
developmental effects In rabbits.
7. Reproductive effects
A supplementary reproduction study In the rat
has been reviewed. In this study groups of 10 male and 10 female
FB3Q (stock Elberfeld) rats were fed doses of either 0, 3, 15, or
75 ppm fenthlon In their feed for 3 generations. The study
reported that chronic 1ngest1on of fenthlon by rats 1n doses up
to 75 ppm 1n feed over 3 generations did not appear to have any
adverse effects on reproduction. However, the Agency cannot
perform an adequate toxicological evaluation of the study without
the raw data set forth below. Therefore, either the raw data
from the existing study must be submitted to remedy Its
deficiencies or a new mult1-generation reproductive study Is
required.
The following specific data must be submitted
1n order for the Agency to evaluate this existing study:
1) Information on Individual dams;
2) Information on Individual litters per dose level;
3) Information on Individual pups;
4) number of pups per litter for Individual dams at
each dose level;
5) number of Utters per dose level;
6) food consumption;
7) Individual body weights for parents and progeny 1n
each generation; and
8) the pathology report Is Incomplete and has
Insufficient detail.
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8. Hutagenlclty
The Agency has acceptable gene mutation,
structural chromosomal aberrations, and other genotoxlc effects
data for fenthlon. Based on the results of the structural
chromosomal aberrations study the Agency concludes that fenthlon
1s non-mutagen1c 1n male mice up to 25 nig/kg bw (the highest dose
tested); Is moderately toxic at 25 mg/kg bw; and that the
systemic NOEL for mutagenldty 1s 10 mg/kg bw. Fenthlon produced
no mutagenlc effects 1n either the gene mutation test or the
other genotoxlc effects test. No additional mutagenldty tests
are required.
C. ECOLOGICAL EFFECTS
The available studies show that fenthlon Is
extremely hazardous, especially to birds and aquatic
Invertebrates. However, these studies do not provide sufficient
Information to quantify or evaluate ecological hazard. A
discussion of the available ecological effects Information Is
set forth below.
1. Terrestrial Organisms
Fenthlon Is very highly toxic to birds as
demonstrated by both acute and dietary studies. Acute oral
tests with mallards, bobwhlte quail, and doves resulted 1n 1050'$
of 5.94 mg/kg, <_ 4 mg/kg, and 2.5 mg/kg, respectively. Dietary
studies (8 days) with bobwhlte and mallards resulted 1n LCso's of
30 ppm and 231 ppm, respectively. The potential for secondary
toxlclty was demonstrated when kestrels were fed, and
subsequently died from, house sparrows that had been killed by an
oral dose of 10 mg/kg fenthlon. Field studies and Incident
reports demonstrate that when used as directed for mosquito and
fly control, cattle treatment, and as a bird perch avlclde,
fenthlon will cause nontarget avlan, and possibly mammalian,
mortality. Birds and mammals were found dead following an
application of fenthlon at 0.04 to 0.05 Ib. a1/A. Thus there 1s
evidence that when fenthlon Is applied even at rates as low as
0.05 Ib. a1/A, bird, and possibly mammal mortality will occur.
2. Aquatic Organisms
Available acute test results Indicate that
fenthlon Is moderately to highly toxic to fish. Acute tests with
fathead minnows and striped bass resulted In LCso's of 3.2 ppm
and 0.453 ppm, respectively. Fenthlon Is very highly toxic to
aquatic Invertebrates (48-hour LCso's of 0.62 ppb and 0.80 ppb
for Slmocephalus (Daphnld) and Daphnla pulex, respectively),
shrimp(90-nour LCso of 0.11 ana a 24-hour LCSQ of less than
0.066 ppb for pink shrimp), and mollusks (EC5y of 340 ppb).
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Fenthlon Is moderately toxic to estuarlne fish with a 96-hour
LCso of 1.6 ppm to striped mullet. Wild caught tadpoles (Rana
catesbe 1 a n a ) were not killed after 96 hours exposure to 5 ppm
fentmon, thus Indicating that fenthlon 1s no more than slightly
toxic to amphibians. Aquatic field testing has shown the use of
fenthlon to control mosquitoes may kill fish and blue crabs.
Field tests have also shown that certain aquatic Invertebrates
such as amphipods and Isopods, will be killed when fenthlon Is
applied directly to water at 0.1 Ib. al/A. and that shrimp will
be killed when fenthlon Is applied directly to water at 0.03 and
0.01 Ib. a1/A.
3. Endangered Species
There are sufficient data to Indicate that
the currently registered uses of fenthlon may affect endangered
species.
Because of Its demonstrated toxldty to
nontarget species and Its Intended use pattern, fenthlon has been
Identified by the U.S. Fish and Wildlife Service (FWS), as being
likely to jeopardize endangered species when used to control or
eradicate mosquito larvae, when used on livestock and as an
avlclde. Based on this determination, FWS specified reasonable
and prudent alternatives to avoid jeopardizing the continued
existence of the Identified species by these uses. EPA 1s
working with the FWS to develop labeling Intended to reduce or
eliminate hazard to endangered species.
4. Non-target Insects
Data from honey bee acute contact toxlclty
studies Indicate that fenthlon Is highly toxic to honey bees
(contact 1050 = 0.308 ug/bee), when bees are exposed to direct
treatment. The requirement for a honey bee acute contact study Is
fulfilled. However, because the acute data Indicate high
toxlclty, a study to characterize the toxlclty of fenthlon
residues on foliage Is required.
D. ENVIRONMENTAL PROFILE
Available data are Insufficient to fully
assess the environmental fate of fenthlon.
1. Degradation
Under aerobic conditions, 14C fenthlon, at 1
ppm, degraded with a half-life of <1 day 1n nonsterlle silt loam
soil In the dark at 75% moisture and room temperature. The
major nonvolatile degradates were fenthlon sulfoxlde, 3-methyl-
4-(methylsulfonyl ) phenol, and 3-methyl-4-(methylsulf1nyl)
phenol. Fenthlon sulfone and 3-methyl-4-(methylsulfony )an1sol e
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were also identified. After 59 days, 3-methyl -4-{»iethyl sul f onyl )
phenol and 3-roethyl-4-linethyl sul fony Jam" sole were the major soil
residues. In sterilized soil, 14C fenthlon degraded with a half-
life of 14-21 days; degradates Included fenthlon sulfoxlde and 3-
raethy1-4-(methylsulflny)phenol.
Under anaerobic conditions, fenthlon, at 0.2
ppm, degraded from 1.9% to 1.0% In silt loam soil after 60 days
Incubation. The major nonvolatile degradate was 3-methyl-4-
(methylsulfonylJphenol. Fenthlon sulfoxlde, fenthlon sulfone,
3-methyl-4-(methylsulf1ny)phenol and 3-nethy1-4-(methylsulfonyJ
anisole were also Isolated.
Aged 1*C fenthion residues (uncharacterized)
were mobile In a column of loam soil leached with 22.5 Inches of
water over a 45-day period. Fenthlon sulfoxlde, fenthlon
sulfone, P«0 sulfoxlde, fenthlon phenol, 3-raethyl-4-(methyl-
sul finyJphenol, and 3-methyl-4-(methyl sul fony Jphenol were
Identified 1n the leachate. The majority of the fenthlon
residues (uncharacterized) remained in the upper 4 centimeters of
the soil column.
The bloconcentration factors for residues of
fenthion, fenthion sulfone, and fenthion oxygen analog sulfone In
carp exposed to 0.01 and 0.1 ppm fenthion were 2000x and 2300x,
respectively. About 50% depuration occurred within 40 days. All
possible degradates could not be determined since the test
substance was not radiolabeled.
2. Ground Water
The Agency reviewed the fenthlon literature
for Information pertaining to fenthion residues In drinking
water, Including ground water. No reports were found regarding
fenthion residues In water. Therefore, the Agency 1s not
proposing to regulate fenthlon for drinking water at the present
time. However, field dissipation studies with fenthlon and
monitoring for degradates,Including 3-methyl-4-(methylsulfonyl)
phenol and 3-methyl-4-(methylsulflnylJphenol, are required. The
Agency Is also requesting leaching studies with fenthion and an
aged leaching study for degradates. When the required data are
submitted, the potential of fenthlon and Its degradates to
contaminate ground water will be reassessed.
3. Reentry
Fenthlon does not meet the acute toxlclty
criteria for requiring reentry data as set forth 1n 40 CFR
section 158.390. However Incident reports 1n the Agency's files,
showing that persons treating animals with fenthlon have
experienced toxic effects, do meet the 40 CFR section 158.390
reentry data criteria. Fenthion also meets the exposure criteria
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of 40 CFR section 158.390 In that fenthion ts registered for use
on ornamentals and the agricultural practices for ornamentals
Include human tasks which Involve substantial exposure to
pesticide treated surfaces.
4. Spray Drift
There are no data available to assess the
risks to nontarget organisms caused by drift from applications
of fenthion. The Agency 1s requiring droplet size spectrum and
spray drift field evaluation tests for fenthion due to the
toxldty of the chemical, the methods of application (mist blower
or cold fogger), and the likely exposure of off-site humans and
wildlife to the pesticide. The droplet spectrum study 1s to be
performed to reflect the nozzle and other equipment types to be
used In the application of fenthion In various outdoor uses. The
spray drift field evaluation 1s to be performed to reflect the
application equipment use pattern, and typical locations of use
(Including different weather factors) In the application of
fenthion.
E. TOLERANCE REASSESSMENT
Tolerances for residues of the Insecticide
fenthion In or on various raw agricultural commodities (RACs) are
currently expressed In terms of fenthion and Its chol1nesterase
Inhibiting metabolites (40 CFR 180.214). The Agency has
evaluated the residue and toxicology data supporting these
tolerances and has determined that It does not have sufficient
data to support the currently established tolerances for residues
of fenthion. The Agency will make a more complete assessment of
the established tolerances for fenthion after the required
residue and toxicologlcal data are submitted and evaluated.
1. Residue Data
The metabolism of fenthion In plants and
animals Is not adequately understood. Available plant
metabolism data do not provide sufficient Information regarding
the determination of total residues In the treated crops, the
distribution of residues In the plant, and the efficiency of the
extraction procedures. Residues were not sufficiently Identified
In milk and tissues of livestock.
Data gaps exist for plant and animal
metabolism and storage stability. On receipt of the data
requested 1n these sections of the registration standard, the
conclusions stated above regarding the adequacy of established
tolerances are subject to change. Furthermore, since the data
required for Individual commodities are dependent on the
metabolism data, the Agency recommends that metabolism data be
obtained and submitted prior to any required residue data. The
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Agency will not assess tolerances for residues In animal
commodities until the requested animal metabolism studies are
submitted and evaluated.
Adequate gas chromatographlc/flame detection
(GC/FD) methods are available for data collection and enforcement
pertaining to residues of fenthlon and Its chol1nesterase-
1nh1b1t1ng metabolites In or on various commodities. Gas
chromatography/electron capture detector (GC/EC) methods are
available for data collection and enforcement, although these
procedures are very tedious and time-consuming.
The Codex Maximum Residue Limits (MRL)
residue definition 1s expressed as the sum of fenthlon, Its
oxygen analog, and their sulfoxldes and sulfones, expressed as
fenthlon; the current U.S. Tolerance definition 1s expressed as
residues of fenthlon and Its chol1nesterase - 1 nh1bl11ng
metabolites. Although these definitions are phrased somewhat
differently, the Agency feels that they are equivalent. A
decision regarding the potential for compatibility between the
permanent Codex MRL and the U.S. tolerances for milk and fat,
meat, meat by products of cattle and hogs will not be made until
the adequacy of the U. S. tolerances have been ascertained.
Codex MRLs have been established for residues of fenthlon 1n
rice, fat, meat, meat by products of cattle and hogs, and milk;
Mexican tolerances have been established for residues of fenthlon
1n or on rice, rice straw, alfalfa, and alfalfa hay; and Canadian
tolerances have been established for fat, meat, meat by products
of cattle, hogs, and sheep.
2. Toxicology Data
The available toxlclty data are Insufficient
for the Agency to calculate an Acceptable Dally Intake (ADI) for
fenthlon and therefore the Maximum Permissible Intake (MPI) for a
60 kg human has not been determined.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
1. Special Review
The Agency 1s not Initiating a special review
for fenthlon at this tine.
Rationale: Although the Agency's review of
ecological data shows that bird kills, due to the use of fenthlon
for mosquito control, for bird control, and for use on animals
for Insect control, have been reported, and that aquatic uses for
mosquito control may cause adverse effects to fish and aquatic
Invertebrates, additional data are needed before the Agency can
complete a full assessment of this hazard potential. Therefore,
based on the review and evaluation of all available data and
other relevant Information on fenthlon, the Agency has determined
that a special review of fenthlon 1s not supported by the
available data at this time. However, the Agency 1s requiring
additional data, I.e., an avlan reproduction study, terrestrial
and aquatic field testing. When those data have been received
and evaluated EPA will determine If It should place the chemical
1n Special Review.
2. Restricted Use
The Agency 1s classifying all fenthion end-
use products with directions for use on agricultural crops,
ornamental plants and forest trees, uncultivated agricultural and
non-agricultural outdoor areas, aquatic sites, livestock and bird
roosting areas as Restricted Use pesticides, based on avian, fish
and aquatic Invertebrate toxlclty. It Is the Agency's position
that affected products must bear appropriate restricted use
labeling 1n order to remain in compliance with FIFRA.
Rationale: The uses of fenthlon listed above
exceeds restricted use criteria. According to 40 CFR 162.11 (c)
a pesticide is a candidate for restricted use if exposure to the
pesticide will exceed l/5th the avlan LCso and l/10th the acute
LCso for aquatic organisms, or 1f use causes more than minor or
nondiscernible adverse effects. Furthermore, 1f application
procedures require specialized training and/or expertise and 1f
failure to follow the use directions In a minor way would result
In more than minor or nondiscernible adverse effects, the
pesticide nay be restricted. Although Incident data in the
Agency's files are limited, the Agency believes that even a few
reported incidents are considered significant since it is
believed that most incidents go undetected or unreported. The
incidents reported coupled with the high toxlclty of fenthlon to
birds and aquatic organisms suggests that more than minor or non-
discernible adverse effects could result from Inadvertent misuse
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and/or misapplication. In addition, most of the uses for
mosquito and bird control requires specialized training and
equipment. Thus, the Agency Is requiring that the uses of
fenthlon Identified above be classified for restricted use In
order to ensure that fenthlon 1s applied efficiently and
properly.
3. Reentry Requirements
The Agency Is establishing an Interim 24-hour
reentry Interval for the use of fenthlon on ornamentals until
adequate data have been submitted and evaluated.
Rationale: Fenthlon Is categorized as a
Toxldty Category II pesticide by the dermal route. It 1s also a
chol1nesterase Inhibitor. It Is registered for use on
ornamentals, the agricultural practices for which Involve
substantial hand labor and therefore substantial potential
exposure to fenthlon treated surfaces. The Agency believes that
a 24-hour Interim reentry Interval Is necessary to protect
workers who may enter treated areas following application.
4. Groundwater Concerns
Groundwater and drinking water monitoring
are not required for fenthlon's major metabolites at this time.
Rationale; The Agency reviewed the fenthlon
literature for Information pertaining to fenthlon residues 1n
drinking water, including groundwater- No reports were found
regarding fenthlon residues in water. The Agency Is requesting
field dissipation studies with fenthlon, with monitoring for
degradates, Including 3-methyl-4-(methylsulfonyl )phenol and 3-
methyl-4-(methylsulflnyl) phenol. The Agency 1s also requiring
leaching studies with fenthlon and an aged leaching study for
degradates.
5. Protective Clothing
The Agency 1s requiring protective clothing
for workers who mix, load or apply fenthlon, dispose of fenthion
products, repair contaminated mixing/loading and application
equipment, or reenter treated areas before the 24-hour reentry
Interval has expired.
Rationale: Generally, protective clothing
requirements for earjy reentry of workers Into treated areas
before the expiration of the reentry Interval are based on the
acute toxiclty of the active Ingredient. Fenthlon is 1n acute
Toxlclty Category II. In addition, the National Institute of
Occupational Safety and Health has evaluated cases of peripheral
neuropathy among veterinarians and allied personnel In a
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veterinary medical cl.inlc. These data suggest that fenthlon may
be Implicated In the etiology of the cases^FR Notice 50, No. 23,
4913 Issued Monday, February 4, 1985). —
Therefore, based on the Toxlclty Category of
fenthlon and Implication of fenthlon with peripheral neuropathy,
the Agency has determined I',at the protective clothing
requirements described in the "Required Labeling" section of this
document are appropriate for workers who mix, load or apply
fenthlon, repair contaminated mixing/loading and application
equipment, dispose of fenthlon products, or need to reenter
treated areas soon after application.
6. Special Ocular Effects Study
The Agency 1s requiring special studies, in
rodent and nonrodent species, on the effects of fenthlon on the
eye.
Rationale: Organophosphate pesticides have
been known to produTe toxic n r f e c t s on the eye, ranging 1n
severity from myopia to congestion or atrophy of the optic nerve.
Fenthlon studies in the Agency's files lack specific attention to
the pathology of the eye.
7- Tolerances and New Food Uses
The Aaency will not issue any tolerances for
significant new food uses*.
Rationale; Until such time as reassessment
of the present tolerances for fenthlon 1s completed, the Agency
will not issue tolerances for significant new food uses. The
Agency needs additional residue and metabolism data 1n order to
characterize the nature of residues In plants and animals. The
Agency also needs specific toxlcity data to calculate the
Acceptable Dally Intake (ADI) to perform a tolerance reassess-
ment. The Agency's calculated Theoretical Maximum Residue
Contribution (TMRC) for fenthlon, based on existing tolerances,
is .0733 mg/kg.
8. Feed Additive Tolerance for Fenthlon Residues
in or on Rice Hulls
The Agency will propose a food additive
tolerance for fenthlon and Its chol1nesterase-inh1bit1 ng
4 "New use" Is defined In 40 CFR 152.3(p). In the case of a
new food or feed use, the Agency will generally consider as
significant an increase In the Theoretical Maximum Residue
Contribution (TMRC) of greater than 1%.
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metabolites In rice hulls at 0.6 ppm. This will be done when
tolerances for fenthlon are next Issued.
Rat1onale: There 1s currently no feed
additive tolerance estaDiisned for fenthlon on rice hulls.
Although residues did not concentrate In rice bran or milled rice
processed from rice bearing measurable weathered residues they
did concentrate 1n rice hulls by a factor of 3 to 6X.
9. Tolerance for Fenthlon residues In or on
Kangeiana BrasseT
A tolerance must be proposed for residues of
fenthlon In or on rangeland grasses to support this use on
rangeland under Section 24(c) Special Local Need Registrations.
In Heu of proposing a tolerance the site "rangeland" must be
removed from the labeling. The reglstrant(s) must Inform the
Agency within 90 days which option Is selected.
Rationale; No tolerances exist for residues
of fenthlon on rangeiand.However, three 24(c) Special Local
Need Registrations (HY780005, HY780007 and WY790005) pertain to
use on rangeland as well as pasture grasses.
10. Pre-Slaughter Intervals (PSIs)
Agency policy Indicates that the maximum
allowable pre-slaughter Interval (PSI) cannot exceed 3 days.
Data are being requested to determine an adequate tolerance
level for 3 day PSI from rangeland and pasture grasses treatment
and direct animal treatments. For use on rangeland, as well as
pasture grasses, the labels must be revised to Include a
statement that livestock must be removed from the field during
spraying and not allowed to graze until 7 days after treatment.
Once the appropriate data are developed and tolerance levels are
established for a 3 day PSI, this label restriction may be
removed.
For direct animal treatments, present
labeling requires a PSI from 14-45 days. This PSI must also be
brought In line with the 3 day PSI policy of the Agency.
However, the available data precludes any decision on the
appropriateness of the established tolerances to support a
change In the PSI to less than 14 days.
Rationale; A 28 day PSI currently exists for
three Special Local Need registrations (HY780005, WY780007 and
HY790005) 1f livestock feed on treated material within seven days
of treatment or 1f they remain In the field while 1t 1s being
sprayed. Also several products currently registered for direct
animal treatment require PSIs of 14 to 45 days. This exceeds the
maximum allowable pre-slaughter Interval of 3 days and 1s
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considered Impractical. The Agency Is accepting only short PSIs
(0 to 3 days) to reduce the chance of Illegal residues 1n Mjat
products.
11. Modified Use Label Statement In Lieu of
Residue uata ror Mater, irrigated uropTi F1sh
ana shellfish
The Agency will accept the following modified
use labeling 1n lieu of residue data for water, Irrigated crops,
fish and shellfish: "Broadcast application may not be used over
aquatic sites which Include drainage ditches, stagnant and
standing water and Intermittently flooded areas adjacent to
bodies of water used for commercial fishing, shellfish
harvesting or Irrigation purposes.
Rationale: Since the current use sites
Include tidal areasand bodies of water that could be used as
Irrigation water, residue data 1n water and shellfish are
required. However, the suggested use modification labeling
would prohibit the use of fenthlon around bodies of water used
for crop Irrigation and potable water and where fish and
shellfish are grown and/or harvested thus making It unlikely
that fenthlon residues would be present In potable water,
Irrigated crops, fish and shellfish. Registrants must Inform
the Agency within 90 days whether they Intend to provide residue
data, or use the label prohibition.
12. Endangered Species Concerns
The U.S. Fish and Wildlife Service (PUS) has
determined that certain uses of fenthlon may jeopardize the
continued existence of endangered species or critical habitat of
certain endangered species. EPA 1s developing a program to
reduce or eliminate exposure to these species to a point where
use to control mosquitoes does not result In jeopardy, and will
Issue notice of any necessary labeling. Labeling for the
livestock and bird control uses will be required when FHS
responds to EPA's request for further Information.
No additional labeling Is being required at
this time. As explained below for the mosquito control use,
labeling requirements Issued In PR Notices 87-4 and 87-5 have
been withdrawn temporarily.
Rationale: In May 1987, EPA Issued PR Notices
87-4 and 87-5 1n response to FWS findings that certain
pesticides, Including fenthlon used to control mosquitoes,
jeopardized the continued existence of endangered species.
Those PR Notices directed registrants to add labeling to their
products which referred users to additional Information that, In
turn, explained limitations on use of the pesticide within the
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range of jeopardized endangered species. Subsequent to Issuance
of these PR Notices, EPA Identified a number of significant
technical errors and Inconsistencies In the Information to which
users would have been referred. Therefore, on January 26, 1988
the Agency Issued PR Notice 88-1 which withdrew PR Notices 87-4
and 87-5 pending development of a more focused program to
protect endangered species.
EPA 1s working to correct these errors prior
to requiring labeling under the cluster program to protect
endangered species. When that program 1s fully developed,
notice of any labeling necessary to protect endangered species
will be Issued. However, case by case endangered species
consultation may still result In the need for labeling and this
labeling can be required on uses not covered by the cluster
program at any time.
13. Nontarget Organism Labeling
In order to comply 1n part to the statutory
standard for continued registration, the Agency has determined
that fenthlon products must bear revised and updated labeling
for hazards to nontarget organisms. The specific statements are
given In Section IV. B. of this Standard.
Rationale: Available data show that fenthlon
Is very highly toxfcto birds, aquatic organisms, and honey
bees. Precautionary label statements relative to the potential
risks posed by fenthlon to nontarget organisms will provide
useful Information to promote practices to limit such exposure
of nontarget species to this pesticide.
14. Spray Drift Data Requirements
Droplet Spectrum and Spray Drift Field
Evaluation tests are required. The droplet spectrum study must
be performed to reflect the commonly-used nozzle and other
equipment types which are used 1n the application of fenthlon 1n
various outdoor uses. The spray drift field evaluation must be
performed to reflect the commonly-used application equipment,
use patterns, and typical locations of use (Including different
weather factors) 1n the application of fenthlon.
Rationale: The Agency Is concerned about
risks to off-site humans and wildlife caused by drift from mist-
blower and cold fogger applications of fenthlon. These tests
are required because of the toxic nature of fenthlon and because
the Methods used to apply fenthlon (mist-blower and cold fogger)
may lead to exposure of bystanders and wildlife. These tests
will Indicate the extent of possible drift of this chemical from
normal applications and the data from these tests will enable
the Agency to evaluate the potential risks from the drift.
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15. Data Identified for Immediate Review
The Agency has Identified certain data that
will receive Immediate review when submitted.
Rationale: Certain data are essential to the
Agency's assessment or Fh'is pesticide and Its uses and/or nay
trigger the need for further studies which should be Initiated
as soon as possible. The following studies have been Identified
to receive priority review as soon as they are received by the
Agency:
Section 158.240 - Residue Chemistry
171-4 - Nature of Residues (Metabolism [Plants and
Livestock]). Tiered Study.
171-4 - Residue Storage Stability. Tiered Study.
171-4 - Magnitude of the Residue (Reassessment of
residue data from direct application to
animals based on nature of residues In
livestock tissues)
Section 158.340 - Toxicology
81-7 - Tiered Study.
83-1 and 83-2 - Studies needed for calculation of an
ADI for fenthlon.
Special Testing - Ocular Effects. Needed to evaluate
potential ocular effects of fenthlon.
Section 158.440 - Spray Drift
201-1 and 202-1 - Needed to calculate human exposure
to fenthlon.
16. Continuation of Current Registrations
While the required data are being developed,
currently registered manufacturing-use products (MPs) and end-
use products (EPs) containing fenthlon may be sold, distributed,
formulated and used subject to the terms and conditions specified
1n this Standard. Registrants »ust provide or agree to develop
and provide additional data, as specified 1n the Data Appendices
1n order to maintain existing registrations.
Rationale: Under FIFRA, the Agency does not
normally cancel or withhold registration because data are missing
or are Inadequate [see FIFRA section 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
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which the Agency will determine If additional regulatory changes
are necessary.
B. Required Labeling
All products must bear appropriate labeling as
specified 1n 40 CFR 156.10, PR Notices 83-2, 83-3, and below.
Appendix II contains further Information on label requirements.
1. Tlroeframes for Compliance
Pesticide products containing fenthlon as an
active Ingredient may not be released for shipment by the
registrant after June 30, 1989 unless the product bears amended
labeling that complies witn tne requirements of FIFRA, as set out
In this Standard.
Pesticide products containing fenthlon as an
active Ingredient may not be distributed or sold after June 30,
1990 unless the product bears amended labeling that complies with
the requirements of FIFRA, as set out In this Standard.
In addition to the above labeling requirements,
the following Information must appear on the labeling of all
manufacturing-use and end-use products.
2. Manufacturing-Use Product Labeling
a. Ingredient Statement
The Ingredient statement must list the
active Ingredient as:
ACTIVE INGREDIENT:
Fenthlon (0.0-d1methyl-0-[4-(methylthlo)-
m-tolyl] phosphorothloate) %
INERT INGREDIENTS %
b. Use Pattern Statements
All products must state that they are
Intended for formulation Into other manufacturing-use or end-use
products for acceptable use patterns. However, no use nay be
Included on the label where the registrant falls to agree to
comply with the data requirements 1n Table A for that use
pattern.
To be registered under this Standard,
manufacturing-use products may be labeled for formulation Into
end-use products only for the commodities listed below.
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TERRESTRIAL FOOD CROP
(Agricultural Crops}
o Agricultural Crops (nonbearlng)
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
< •>
o Alfalfa
o Pasture (grasses)
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
0 Forest Trees
o Ornamental Herbaceous Plants (Including begonia,
chrysanthemum, geranium, Illy, marigold,
peony, phlox, petunia, snapdragon, verbena,
and zinnia)
o Ornamental Plants (nonbearlng)
o Ornamental Shade Trees (Including arborvltae,
ash, aspen, birch, dogwood, juniper, maple,
oak, sweetgum, and tuliptree)
o Ornamental Weedy Shrubs (Including eunonymus,
roses, and viburnum)
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
o Bird Roosting Areas
o Bridges
o Buildings, Outdoor
o Industrial Sites (pipe yards)
o Loading Docks
o Uncultivated Non-Agricultural Areas
o Rice
AQUATIC FOOD CROP
(Agricultural Crops)
AQUATIC NONFOOD
(Aquatic Sites)
o Aquatic Sites (Including catch basins, ditches,
lakes, marshes, ponds, stagnant streams,
standing water, swamps, and tidal areas)
INDOOR
(Animals and Their Man-made Premises)
o Beef Cattle
o Dairy Cattle (non-lactat1ng)
o Hogs
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(Agricultural Premises and Equipment)
o Agricultural Premises
o Beef Cattle Barns
o Dairy Barns
o Poultry Houses
(Domestic Dwellings)
o Domestic Dwellings, Indoor
o Domestic Dwellings, Outdoor
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
o Wide Area and General Outdoor Treatments
(Commercial and Industrial Uses)
o Commercial Establishments (Indoor, Inedible)
o Commercial Establishments, Outdoor
o Eating Establishments (Indoor, Inedible)
o Food Processing Plants (Indoor, Inedible)
c. Environmental Hazards Statement
The following environmental hazard
statement must appear on all manufacturing use labels:
"This pesticide 1s toxic to fish and
wildlife. Do not discharge effluent
containing this product Into lakes,
streams, ponds, estuaries, oceans, or
public waters unless this product 1s
specifically Identified and addressed 1n
an 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 Environmental Protection Agency."
2. End-Use Product Labeling
All end-use products must bear the following
labeling statements:
a. Ingredients Statement
as active Ingredients
Solvents or diluents currently declared
In the Ingredients statement must be
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Included In the total of Inert Ingredients. The Agency does not
have data Indicating that these solvents are Insectlcldal.
b. Restricted Use Statement
All end-use product containing fenthlon
as an active Ingredient with directions for use on agricultural
crops, ornamental plants and forest trees, uncultivated agricul-
tural outdoor areas, aquatic sites, livestock and bird roosting
areas must bear the following restricted use labeling statements:
"RESTRICTED USE PESTICIDE
Due to Very High Acute Toxidty to Birds. Fish and
Aquatic Invertebrates
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.
Certified applicators must also ensure that
all persons involved in these activities are
Informed of the precautionary statements."
c. Environmental Hazards
One of the following environmental
hazard statements must appear on the label of fenthlon products:
Granular (Aquatic Larvicide)
"This pesticide is toxic to shrimp,fish
and wildlife. Birds, fish, shrimp.and
crabs in treated areas may be killed. Do
not contaminate untreated water when
disposing of equipment washwaters."
Nongranular (Monaquatic Use Sites)
"This pesticide is highly toxic to
shrimp, fish and wildlife. Birds, fish,
shrimp, and crabs in treated areas may
be killed. Do not apply directly to
water or wetlands (Including swamps,
marshes, bogs, and potholes). Runoff
and drift from treated areas may be
hazardous to aquatic organisms in
adjacent aquatic sites. Do not
contaminate water when disposing of
equipment washwaters."
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Nongranular (Aquatic Use Sites)
"This pesticide Is highly toxic to
shrimp, fish and wildlife. Birds, fish,
shrimp, and crabs In treated areas may
be killed. Do not apply where these are
Important resources. Drift and aquatic
transport from treated r-eas may be
hazardous to aquatic organisms In
adjacent aquatic sites. Do not
contaminate untreated water when
disposing of equipment washwaters."
d. Personal Protective Equipment and Work
Safety
The following personal protective
equipment and work safety statements must appear on the labeling
of all products bearing the signal word "WARNING":
"USE ONL7 WHEN WEARING THE FOLLOWING
PERSONAL PROTECTIVE EQUIPMENT DURING
HIXING/LOADING, APPLICATION, REPAIR AND
CLEANING OF MIXING, LOADING, AND
APPLICATION EQUIPMENT. DISPOSAL OF THE
PESTICIDE: protective suit of one or
two pieces that covers all parts of the
body except head, hands, and feet;
chemical-reststant gloves; chemical-
resistant shoes (or chemical-resistant
shoe coverings or chemical-resl stant
boots); and a NIOSH or MSHA approved
respiratory protection device. In
addition, mixers/loaders must wear a
chemical resistant apron. During
equipment repair and cleaning, 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-sleeve shirt; long-
legged pants; chemical-resistant gloves;
chemical-resl stant apron; shoes and
socks. Goggles or face shield must be
worn when the system 1s under pressure.
All other protective clothing and
equipment required for use with open
systems must be available nearby.
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IF APPLICATION IS PERFORMED USING AN
ENCLOSED CAB OR COCKPIT, THE FOLLOWING
PROTECTIVE CLOTHING AND EQUIPMENT MAY BE
WORN AS AN ALTERNATIVE: Long-sleeve
shirt and long-legged pants; shoes and
socks. Chemical -reststant gloves must
be available 1n the cab or cockpit and
must be worn during entry to and exit
from the application vehicle. All
other protective clothing and equipment
required for use during application must
be available 1n the cab and must be worn
when exiting the cab Into treated area.
When used for this purpose, contaminated
clothing may not be brought back Into
the cab unless In an enclosure such as a
plastic bag. REMEMBER - THIS CLOTHING
IS INADEQUATE TO PROTECT YOU DURING
REPAIR AND CLEANING OF APPLICATION
EQUIPMENT AND EARLY REENTRY TO TREATED
AREAS! REFER TO PROTECTIVE CLOTHING AND
EQUIPMENT REQUIREMENTS ABOVE.
IMPORTANT! If pesticide comes 1n
contact with skin, wash off with soap
and water and contact a physician
Immediately. Always wash hands, face,
and arms with soap and water before
smoking, eating, drinking, or using the
toilet.
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
respirators. Clothing and that becomes
heavily contaminated or drenched with
fenthlon must be destroyed according to
State and local regulations. HEAVILY
CONTAMINATED OR DRENCHED CLOTHING CANNOT
BE ADEQUATELY DECONTAMINATED.
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The following personal protective
equipment and work safety statements must appear on the labeling
of all products bearing the signal word "CAUTION":
USE ONLY WHEN WEARING THE FOLLOWING
PROTECTIVE CLOTHING AND EQUIPMENT DURING
MIXING/LOADING, APPLICATION, REPAIR AND
CLEANING OF NIXING, LOADING, AND
APPLICATION EQUIPMENT, AND DISPOSAL OF
THE PESTICIDE: Wear a long-sleeved
shirt and long-legged pants, shoes,
socks and chemical-resistant gloves,
IMPORTANT! If pesticide comes 1n
contact with skin, wash off with soap
and water. Always wash hands, face, and
arms with soap and water before smoking
eating, drinking, or using the toilet.
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. Clothing worn during work
must be laundered separately from
household articles. Clothing that
becomes heavily contaminated or drenched
with fenthlon must be destroyed
according to state and local
regulations. HEAVILY CONTAMINATED OR
DRENCHED CLOTHING CANNOT BE ADEQUATELY
DECONTAMINATED.
e. Bee Precautions
The following bee precautionary
statement must appear on the label of all fenthlon products
Intended for outdoor use (except granular formulations):
"This product 1s highly toxic to bees
exposed to direct treatment on blooming
crops or weeds. Do not apply this
product or allow It to drift to blooming
crops or weeds while bees are visiting
the treatment area."
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f. Reentry
The following reentry statements must
appear on the labeling of all fenthlon products labeled for use
on ornamentals:
Reentry
"Reentry Into treated area Is prohibited
for 24 hours (1 day) after the end of
application, unless the protective
clothing specified on this label for
early reentry Is worn.
FOR EARLY REENTRY INTO TREATED AREAS
BEFORE SPRAYS HAVE DRIED LOR DUST HAS
SETTLED, as appllcablej wear all
protective clothing specified on this
label for an applicator-
FOR EARLY REENTRY INTO TREATED AREAS
AFTER SPRAYS HAVE DRIED LOR DUST HAS
SETTLED, as appllcablej wear protective
suit of one or two pieces covering all
parts of the body except head, hands,
and feet; chemical-reslstant gloves;
chemical -reslstant shoes (or chemical-
resistant shoe coverings or chemical-
resistant boots).
g. Storage and Disposal
All products must have the appropriate
storage and disposal statements on the label. Refer to Appendix
II for the appropriate statements.
h. Use Directions from EPA's Index to
Pesticide Chemicals
For avlclde uses; Applications are to
be made by persons trained Tn bird control. Local, state and
federal permits must be obtained before use. Do not use fenthlon
as a surface treatment. Use only 1n liquid-filled perches. Do
not allow fenthlon to contact skin. Not for use Inside food
storage, processing or handling premises; substance must not
contaminate foods or feeds. Do not expose this substance 1n any
manner that nay endanger nontarget birds and other animals. Keep
areas to be treated free of bird food and feed. Do not apply, or
allow to drift, to roosting areas near human habitation or non-
target animals. Install 'perches' out of reach of Irresponsible
persons. Collect and properly dispose of all dead birds and
drain substance from perches when desired control Is
achieved.
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For domestic dwelling, Indoor residual
application: Apply as a coarse spray or by paint Drusn.Treat
arouna aoors, windows, and light fixtures. Repeat as needed. Ho
not use In areas where children or pets can come Into direct
contact with treated surfaces.
For domestic dwelling, Indoor crack and
crevice treatment: Apply as a crack and crevice treatment. Uo
ifoTuse fn areas where children or pets can come Into direct
contact with treated surfaces.
For domestic dwelling, outdoor residual
application: Apply as a coarsesprayorby palntbrush.For
ants, thoroughly wet hills and runways. For house fly, spray
around windows and other surfaces frequented by pests.
For commercial and Industrial uses
((commercial estab!1shments;, inaoor , ineaiDie) (eating
establishments, indoor, inedible) and (food processing plants,
indoor, inedible)), Tn'aoor appi 1 cation": Apply as a coarse spray.
or with a paint brush, or as a cracK and crevice treatment.
For commercial establishments, outdoor
residual application: Apply as a coarse spray or oy paint brush.
For ants, thoroughly wet hills and runways. For house fly, spray
around windows and other surfaces frequented by pests.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
Identified 1n Section II.A. are subject to certain requirements
for data submission or changes 1n composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product 1s a manufacturing or end use product and
whether the pesticide 1s the sole active Ingredient or one of
multiple active Ingredients.
Products are subject to this Registration Standard as
foilows:
A. Manufacturing-use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (1f tny) upon use, composition,
or packaging listed 1n Section IV, If they pertain to the
manufacturing-use product.
2. The data requirements listed 1n Tables A and B5
3. The labeling requtremerats specified for
manufacturing-use products In Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstratlon.
5Data 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 tills Registration
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 1s eligible for the formulator's
exemption for that active Ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, In most cases, 1t will
not require the submission of product-specific data for end use
products at this time. Therefore most Registration Standards do
not contain a Table C.
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33
B. Manufactureng-use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The restrictions (1f any) upon use, composition,
or packaging listed 1n Section IV, 1f they pertain to the
manufacturing-use product.
2. The labeling requirements specified for
manufacturing-use products 1n Section IV.
3. The data requirements listed In Table A.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstratlon.
C. End-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 end-use
product.
2. If eligible for the forraulator's exemption5, the
data requirements listed in Table C (1f Included).
6If you purchase from another producer and use as the source
of your active Ingredient only EPA-reglstered 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 1n 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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34
3. If not eligible for the formulator's exemption,
the data requirements listed In Table A and the data requirements
listed 1n Table C { 1f included).
4. The labeling requirements specified for end-use
products 1n Section IV.
5. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstratlon.
0. End-use products containing this pesticide as one of
multiple acTTve ingredients are subject to:
1. The restrictions (1f any) upon use, composition,
or packaging listed in Section IV if they pertain to the end-use
product.
2. If not eligible for the formulator's exemption,
the data requirements listed In Table A and Table C (1f
included).
3. If eligible for the formulator's exemption, the
data requirements listed in Table C (1f included).
4. The labeling requirements specified for end-use
products in Section IV.
5. Adrainistrative requirements (application forras,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstratlon.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard 1s a notice Issued
u•
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36
If you are not now eligible for a formulator's
exemption, you may qualify for one 1f you change your source of
supply to a registered source that does not share ownership 1n
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 1f, 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 fall 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 da t"a"! BITE wTTI rfo~tb~esubml tti ng life data
yourself.If you use fhls 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 1n an agreement and the
other 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
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37
that you nay rely upon Its submission. The Agency will also
require adequate assurance that the person whom you state will
provide the data 1s taking appropriate steps to secure 1t. 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 11st 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 11st of the products affected (from all
members of the consortium); and
e. Identification of the specific data that the
consortium 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
otter. YOU request tnat EPA not suspend your registration foT
non-compliance with the DCiT EPA nas determined that, as a
general policy, it win 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.j
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
Development 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 mall receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share 1n the burden of
producing the data required pursuant to FIFRA sec.
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38
3(c)(2)(B) 1n the [name of active IngredlentJ Registration
Standard upon terms to be agreed or falling agreement to be
bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(111).
The remainder of your offer nay not In any way attempt to limit
this commitment. If the other registrant to whom your offer 1s
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 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 falls 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 tlmeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If
you believe thaT a data requf rement does h~6~fTor snoul d 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 1n determining that a data requirement
applies, EPA does not anticipate that many waivers will be
granted. A request for waiver does not extend the tlmeframes for
developing required data, and if your waiver request is denied
your registration may be suspended If you fall to submit the
data.
deleting
required
label.
5.
the
You
uses
to submit
request that EPA amend your registration by
for
data
which
for
the
uses
data are needed.
which
are
no 1 o
YOU
nger
are
on
not
your
6. You request voluntary cancellation of the
registration of your profluct(s) for which the data are needed.
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
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39
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, 5385 Port
Royal Road, Springfield. VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable 1f the
OECD-reconmended test standards conform to those specified In the
Pesticide Data Requirements regulation (Part 158.70). Please
note, however, that certain OECD standards (such astest
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 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.
F- 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 tlmeframe for submission of
the data, nor will extensions generally be given to conduct
studies due to submlttal of Inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data then Is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which 1s Bade as an Initial response to a section
3(c)(2)(B) request notice must be submitted 1n writing to the
Product Manager listed at the end of this section and must be
made by the 90-day deadline for response. Once dates have been
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40
committed to and EPA has accepted these commitments, any
subsequent requests for a time extension must be submitted in
writing to the Office of Compliance Monitoring at the address
given 1n 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 1s 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
tlmeframe for submission of the data. If EPA denies your request
for a time extension and you do not submit the data as requested,
EPA nay 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 1n 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 1s
suspended for failure to respond to a DCI 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 fn 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 such permission
would be consistent with the Act. The following Information must
be Included In any request for an existing stocks provision:
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41
1. Explanation of why an existing stocks
provision 1s 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
consistent with the provisions of FIFRA.
Registrants are reminded that FIFRA sec. 6(a){2)
requires them to submit factual Information concerning possible
unreasonable adverse effects of a pesticide at any time that they
become aware of such Information. Registrants should notify the
Agency of any Information. Including Interim or preliminary
results of studies. If those results suggest possible adverse
effects on man or the environment. This requirement continues as
long as the products are registered by the Agency.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under Its OCI 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 1n Table B. If you have an end-use product, the data are
listed 1n Table C. As noted earlier, the Agency has decided that
1t will not routinely require product-specific data for end-use
products at this time. Therefore, Table C may not be contained
in this Registration Standard; if there 1s no Table C, you are
not required to submit the data at this time.
In order to comply with the product specific data
requirements, 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-spec 1f1c data
requirements for your products will result 1n suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELS
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
1n 40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified 1n Section IV.D of this Registration
Standard. Applications submitted 1n response to this notice must
Include draft labeling for Agency review.
If you fall to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific Instructions
1n Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMISSION
n
A. Manufacturing-Use Products (MUPs) containing the
subject pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to tir<> .product Manager 1n 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.8
b. Confidential Statement of Formula (EPA Form
8570-4)
c. Generic Data Exemption Statement
(Formulator's Exemption Statement) (EPA Form
8570-27), 1f applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer
to 40 CFR 152.80 - 152.99.
2. Within 9 months from receipt of this document you
must submit to tne Product Manager:
a. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
b. Two copies of any required product-specific
data (see Table B).
c. Product Specific Data Report
(EPA Form 8580-4).
d. Three copies of draft labeling, as specified
1n Chapter IV.D. Required Labeling, Including
the container l abe I a¥a i~ny associated
8If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement 1s 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 1n
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.)
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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 nust Indicate the Intended colors of
the final label, clenr Indication of the
front panel of the label, and the Intended
type sizes of the text.
3. Within the times set forth 1n Table A, you must
submit to the Registration Division ail generic data, unless you
are eligible for the fornulator'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 otner active ingredients.
1. Within 90 days from receipt of this document, you
must submit to tne product Manager In the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachmentsx (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Generic Data Exemption Statement
(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 Manger:
a. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
b. Three copies of draft labeling, as specified
In Chapter IV.D. Required Labeling,
Including the cental ner label 51T3 affy
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 1n 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.
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46
3. Within the time frames set forth 1n Table A, you
must submit to the Registration LMVISIC 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 «et>urse of action.
C. End-Use Products containing the subject pesticide as,
sole active ingreaientT
1. Within 90 days from receipt of this document, you
must submit to tne Product Manager In the Registration Division:
a. Generic Data Exemption Statement
(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, 1f
required by Table C (1f Included).
b. Product Specific Data Report (EPA Form 8580-4
If Table C lists required product-specific
data.
c. Three copies of draft labeling, as specified
1n Chapter IV.D. Required labeling,
Including the conta 1 ner label a~n~a a~h~y
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. End-Use Products containing the subject pesticide In
combination with other active ingredienTsT
1. Within 9 months from receipt of this document you
must submit to tne Product Manager:
a. Three copies of draft labeling, as specified
In Chapter IV.D. Required labeling,
Including the conta i ner label OH TrTy
associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x
11 Inch paper or a mockup of the labeling
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47
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.
E. Intrastate Products containing the subject pesticide
either as sole active ingreaient or in combination witn otner
active ingredients.
Applications for full federal registration of
Intrastate products are required to be submitted no later than
July 31, 1988.
F. Addresses
The required Information must be submitted to the
following address:
George T. LaRocca (PM 15)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
The address for submissions to the Office of Compliance
Monitoring Is:
Laboratory Data Integrity Assurance Division
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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I. DATA APPHIiblCES
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49
TGUIDE-1
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
tothe 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 tne order in which they appear In 40 CFR 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 or Fn"e~ 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
HP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named 1n 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 CFR Part 158. The following letter
designations are used for the given use patterns:
A « Terrestrial, food
B « Terrestrial, non-food
C • Aquatic, food
D * Aquatic, non-food
E = Greenhouse, food
-------
50
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined In a footnote to the
table.
4. Does EPA have data? (Column 4). This column Indicates one
of three answers:
YES - EPA has data 1n Its files that completely satisfy
thls 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 1n Its files, but such
data (To hot 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
fo" 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
1nformatlon.
5. B1 b11 ograph 1 c c 1 tat 1 on (Column 5). If the Agency has
acceptabledatafnTTsfiles, this column lists the Identifying
number of each study. This normally Is the Master Record
Identification (MRID) number, but may be a GS number 1f 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 wnetnerthe data must be submitted to the Agency. If
column 3 Indicates that the Agency already has data, this column
will usually Indicate NO. If column e 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
-------
51
TGUIDE-3
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 1n a footnote to the
table.
7. Tineframe for submission (Column 7). If column 6 requires
that data oe submitted,this column Indicates when the data are
to be submitted, based on the date of receipt of the Registration
Standard. The tlmeframes are those established either as a
result of a previous Data Call-In letter, or standardized
tlmeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
52
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission1/
Data Requirement
Part 158, Subpart C, Product Chemistry
Product Identity and Composition
61-2 - Description of Starting
Materials and Manufac-
turing 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
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
All
All
All
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
40085801 Reserved2/,3/,*/ 03/21/87
40223002
40085801 Reserved2/.3/,V 03/21/87
40223002
40223001 Reserved2/.3/,6/ 09/22/87
40085802 Reserved2/,3/,7/ 09/22/87
40085802 Reserved2/,3/.7/ 09/22/87
40085802 Reserved2/,3/,7/ 09/22/87
40085802 Reserved2/,3/,8/ 09/22/87
40085802 Reserved2/,3/,9/ 09/22/87
-------
53
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTH ION
Data Requirement
Test
Substance
Use
Patterns
Bibliographic
Does EPA Citation Must Additional
Have Data? (MRID) Data Be Submitted?
Tlmeframe
for
Submission1/
Part 158, Subpart C, Product Chemistry (cont'd)
Physical
and Chemical
Characteristics icont'd)
63-7 -
63-8 -
63-9 -
63-10 -
63-11 -
63-12 -
63-13 -
Density, Bulk Density, or
Specific Gravity
Solubility
Vapor Pressure
Dissociation Constant
Octanol /Water Partition
Coefficient
PH
Stability
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
yes
Yes
Yes
Yes
Yes
Yes
Yes
40085802
40085802
40085802
40085802
40085802
40085802
40085802
Reserved2/,3/
Reserved2/, 3/
Reserved2/,3/
Reserved2/,3/
Reserved2/,3/
Reserved2/,3/
Reserved2/,3/
09/22/87
09/22/87
09/22/87
09/22/87
09/22/87
09/22/87
09/22/87
Other Requirements;
64-1 - Submlttal of Samples
N/A
N/A
N/A
N/A
No
09/22/87
-------
54
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Part 158, Subpart C, Product Chemistry - Footnotes
*/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Comprehensive Data Call-In
letter dated April 29. 1986.
2/ Required for all technical grade fenthlon products. The 95% (EPA Reg. No. 11556-36), 93* EC (EPA Reg. No. 3125-148) and
93% (EPA Reg. No. 3125-197) products are considered technical products.
•V Data submitted 1n response to the April 29, 1986 Comprehensive Data Call-In were not received In time to be Included In
the data base reviewed for this standard. Therefore no determination has been made as to the adequacy of this data In
satisfying the data requirement. Should the data be found unacceptable after Agency review a new study 1s required
under Section 3(c)(2)(B).
V Complete Information must be provided regarding the nature of the process (batch or continuous), the relative amounts
of starting 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 starting material must be provided, along with Information regarding
the properties of each starting material used to manufacture each product.
5/ A detailed discussion of all Impurities that are or may be present at >p.l%, based on knowledge of the starting
materials, chemical reactions (Intended and side) 1n 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 present at
^0.1* (w/w), and each toxlcologlcally significant Inert. Complete validation data (accuracy, precision) must be
submitted for each analytical method used.
-------
55
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Part 158, Subpart C, Product Chemistry - Footnotes (continued)
7/ All physlcochemlcal characteristics of the technical product, or the pure active Ingredient, as required In
40 CFR 158.120 and more fully described In the Pesticide Assessment Guidelines, Subdivision 0,
must be submitted.
8/ Required If the technical chemical Is a solid at room temperature.
^/Required If the technical chemical Is a liquid at room temperature.
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56
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Test
Substance
Bibliographic Tlmeframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission1/
Sec. 158.240 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism)
- Plants
171-4 -
- Livestock
Residue Analytical Methods
- Plant and Animal Residues
171-4 - Storage Stability Data
T6AI
PAIRA
PAJRA
EP and metabolites
No
Yes
Product Label
Partially 00066832.
00075108
Partially 00115886
00154967
TGAI and metabolites Partially
00093415,
00115887,
00115889,
00115895,
00116381,
00116748,
00116750,
00116751,
00154967
Partially 00115889.
00154967
Yes*/
No
Yes5/
Yes6/,7/
18 Months
18 Months
15 Months
Yes7/,8/,9/ 18 Months
-------
57
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission*/
Data Requirement
Sec. 158.240 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
1n Plants
- Crop Field Trials
- Cereal Grains Group*0
° Rice TEP
Forage, Fodder, and
Straw of Cereal
Grains Group11/,12/
0 R1ce Straw TEP
Grass Forage, Fodder, TEP
and Hay Group
Nongrass Animal Feeds
(Forage, Fodder,
Straw, and Hay)
Group18/,19/
o Alfalfa EP
Yes
Partially
Partially
00116749
00154967
00154967
00032871,
00065775,
00065776,
00116399
Partially 00032871,
00065775,
00065776
No
Yes13/
"/,
16/.17,
30 Months
30 Months
30 Months
-------
58
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
(MRID)
Must Additional
Data Be Submitted?
Tlmeframe
for
Submission1/
Sec. 158.240 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Meat/MlIk/Poultry/Eggs TEP
Partially
- Potable Water
- Fish and Shellfish
No
No
00062094,
00071969,
00093415
00093416
00093422
00093459,
00115216
00115886,
00115889,
00115898,
00115908,
00115928,
00115932,
00116381,
00116386,
00116398,
00116748
Reserved^/
15 Months
Yes*5/
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59
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec* 158.240 Residue Chemistry - Footnotes
Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated.
2/ The same chemical Identity data required as under 158.120, with emphasis on Impurities that could constitute residue
problems. Refer to Product Chemistry Data Requirements tables (A and B).
/ The uptake, distribution, and metabolism of ring-labeled [C] fenthlon in alfalfa and a representative grass
following foliar or broadcast application at a rate sufficiently high to permit "C-resldue characterization.
Residue Identities must be conflremed by a method such as GC, HPLC, and/or mass spectrometry. Data reflecting
solvent extraction of fenthlon must also be provided. Representative samples from the required metabolism studies
must also be analyzed using accepted enforcement methods to ascertain that these methods will determine all possible
metabolites of concern.
*/ The registrant should complete and submit all plant metabolism data to the Agency for review prior to Initiation of
residue field trials and processing studies.
5/ Metabolism studies must be submitted utilizing ruminants and poultry. Animals must be dosed for at least 3 days
with ring-labeled L14CJ fenthlon at a concentration 1n the total diet that will result 1n sufficient residues 1n
tissues, milk, and eggs for characterization. Animals must be sacrificed within 24 hours of the final dosing.
Milk and eggs must be collected twice dally. l4C-res1dues 1n muscle, fat, kidney, liver, ml Ik, and eggs must be
characterized. In addition, cattle and swine must be dermal ly dosed with ring-labeled L14CJ fenthlon at a concen-
tration that will result 1n sufficient residues 1n the tissues for characterizations. Animals must be sacrificed
24 hours after treatment and residues characterized In muscle, fat, kidney, liver, and skin (swine only). Represen-
tative samples from the studies requested above must also be analyzed using accepted enforcement methods to ascertain
their validity.
6/ Residues of FSO [0,0-d1methyl-0-[4- (methyl sulflnyD-m-tolyJphosphorothloateJ and FS02 lO.O-d1methy1-0-L4-(methyl-
sulfonyDm-tolyJphosphorothloate] In or on crop samples must be subjected to analysis by multlresldue protocols.
Protocols for Methods I, II, III, and IV are available from the National Technical Information Service under Order
No. PB 203734/AS.
-------
60
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.240 Residue Chemistry - Footnotes (cont'd)
7/ Additional methods, validation data, residue data (for representative commodities), and stability of residues
in storage may be required If the metabolism studies requested in the sections entitled "Nature of the Residue
1n Plants" and "Nature of the Residue in Animals" reveal additional metabolites of toxlcological concern in
plants or animals.
The storage Intervals and conditions of samples used to support all established tolerances for residues of
fenthion and Its cholinesterase-lnhibiting metabolites must be submitted. These data must be accompanied by
data depicting the percent decline in residues of fenthion and its cholinesterase-lnhibiting metabolites at
the times and under the conditions specified. Additional stability studies are not required for: (1) fenthion
and FOSOg in cow "steak" and fat stored at 24°C for up to 6 hours; (11) fenthion in cow liver stored at 24°C
for up to 6 hours; and (ill) fenthion and FOSO 1n or on alfalfa stored at 0 to -10°F for up to 62 weeks. On
receipt of these data, the adequacy of the aforementioned tolerances will be Devaluated.
9/ All requested residue data must be accompanied by data regarding storage length and conditions of storage of
samples analyzed. These data must be accompanied by data depicting the stability of residues of fenthion and
its chol1nesterase-1nhibiting metabolites under the conditions and for the time Intervals specified, with the
exception of: (1) fenthion and FOAS02 in cow "steak" and fat stored for up to 6 hours at 24°C; (11) fenthion
in cow liver stored at 24°C for up to 6 hours; and (ill) fenthion and FOASO in or on alfalfa stored at 0 to
-10°F for up to 62 days.
If the registrant wishes to propose a crop group tolerance, then use directions must be proposed and appropriate
supporting residue data submitted for corn (fresh, sweet, and dried field), sorghum, and wheat.
If the registrant wishes to propose a crop group tolerance, then additional data must be submitted to support the
established tolerance for residues of fenthion 1n or on the representative group member rice straw.
12/ If the registrant wishes to propose a crop group tolerance, then use directions must be proposed and appropriate
supporting residue data submitted for additional representative group members (wheat, sorghum and corn).
13/ Data must be submitted depicting fenthion residues of concern in or on rice straw harvested 30 days following the
last of three applications of an EC formulation at 0.1 Ib ai/A. Tests must be conducted in California.
-------
61
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.240 Residue Chemistry - Footnotes (cont'd)
14/ Data must be submitted reflecting residues of fenthlon and Its chol1nesterase-1nh1biting metabolites In or on
Bermuda grass, bluegrass, and bromegrass or fescue (as fresh grass and hay) treated with four broadcast appli-
cations (at 21-day intervals) of a G Formulation at 0.2 Ib a1/A and, 1n separate tests, four broadcast applica-
tions (at 21-day intervals) of an EC formulation at 0.1 Ib ai/A as: (1) a mist spray by ground equipment using
both low- and high-volume application; (11) a ULV nonthermal aerosol application; and (111) an aerial application
in a conventional dilution applied at a rate of 1 gal finished spray/A. Hater must be used as a carrier and tests
must reflect a 0-day posttreatment Interval. Tests must be conducted in Arkansas (3%), Kansas (4%), Kentucky (6%),
Missouri (11%), New York (5%), Oklahoma (4%), Pennsylvania (4%), Tennessee (4%), Texas (13%), and Virginia (3%)
which produced ca. 57% of the total 1982 domestic hay crop (other than alfalfa and small grains) and which may
represent pasture grasses as well (production figures 1n parentheses obtained from the 1982 Census of Agriculture,
Vol. 1, Pt. 51, p. 330). Tests reflecting the ULV nonthermal aerosol applications must be conducted In Alabama,
Arkansas, Florida, Georgia, Louisiana, Mississippi, Tennessee, and Texas to support the Federal registration, and
in Idaho, Missouri, Oregon, Vermont, and Washington to support the uses permitted under SLN Nos. ID-800056,
MO-840002, OR-800085, UT-800010, and HA-780051.
15/ Data must be submitted depicting residues of fenthlon and Its cholinesterase-1nhibiting metabolites In or on
Bermuda grass, bluegrass, and bromegrass or fescue (as fresh grass and hay) harvested 0-days following two
aerial applications at 21-day Intervals using an oil carrier of the 9.76 Ib ai/gal EC formulation at 0.075
Ib al/A. Tests must be conducted in Hyoming.
16/ Data must be submitted depicting residues of fenthlon and its chollnesterase-inhlbiting metabolites In or on
Bermuda grass, bluegrass, and bromegrass or fescue (as fresh grass and hay) harvested on the day of the last
of four broadcast foliar applications (at 21-day Intervals) of the 7 Ib ai/gal EC formulation (by aircraft
using ULV equipment and a water carrier) at 0.1 Ib ai/A. Tests must be conducted in Oregon where this use Is
permitted.
17/ Data must be submitted depicting residues of fenthlon and its cholinesterase-1nh1biting metabolites in or on
Bermuda grass, bluegrass, and bromegrass or fescue (as fresh grass and hay) harvested on the day of the last
of four applications (made at 21-day Intervals) of the 4 Ib ai/gal EC formulation at 0.1875 Ib a1/A. Tests
roust be conducted in California where this use Is permitted.
18/ If the registrant wishes to propose a crop group tolerance, then use directions must be proposed and appropriate
supporting residue data submitted for the additional representative group member clover (Trifoilurn sppl).
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62
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.240 Residue Chemistry - Footnotes (cont'd)
W if the registrant wishes to propose a crop group tolerance, then additional data are required to support the
existing tolerance for residues of fenthlon and Its chollnesterase-lnhlbiting metabolites In or on alfalfa.
20 / Data must be submitted reflecting residues of fenthlon and Us chol1nesterase-1nh1biting metabolites In or on
fresh alfalfa and alfalfa hay harvested 0-days following the last of foliar broadcast applications (one
application/cutting) at 21-day Intervals of a G formulation at 0.2 Ib a1/A, and, 1n a separate test, an EC
formulation at 0.1 Ib a1/A. Separate tests with the EC formulation are to be made as: (1) a mist spray by
ground equipment using both high- and low-volume applications; (11) an aerial application conventionally
diluted and applied at a rate of 1 gal finished spray/A; and (111) a ULV nonthermal aerosol application.
Water must be used as a carrier. Tests reflecting a ULV nonthermal aerosol application must be conducted
In Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Tennessee, and Texas to support the Federal
registration, and In Idaho, Missouri, Oregon, Vermont, and Washington to support the uses permitted under
SLN Nos. ID-800056, MO-840002, OR-800085, UT-8000010, and WA-780051. All remaining tests must be performed
In California (7%), Iowa (7%), Mississippi (5%), Minnesota (7%), Nebraska (6%), South Dakota (6%), and
Wisconsin (13%), which, together with the neighboring States of Illinois (3%), Montana (3%), North Dakota
(3%), and Ohio (2%), collectively produced 62% of the total alfalfa crop In 1984 (production figures In
parentheses were obtained from Agricultural Statistics, 1985, p. 242).
21/ Data must be submitted depicting residues of fenthlon and Its chollnesterase-lnhlbiting metabolites In or on
fresh alfalfa and alfalfa hay harvested 0-days following the last of broadcast foliar applications at 21-day
Intervals (one treatment per cutting) of the 7 Ib a1/gal EC formulation (applied by aircraft using ULV equipment
and water as a carrier at 0.1 Ib a1/A. Tests must be conducted 1n Oregon which Is the only state where this use
Is permitted.
22/ Data depicting residues of fenthlon and Its chol1nesterase-1nh1biting metabolites In or on fresh alfalfa and
alfalfa hay harvested 0-days following the last of broadcast foliar applications (one application/cutting) at
21-day Intervals (by conventional ground and aircraft equipment) of the 4 Ib al/gal EC formulation at 0.1875
Ib a1/A. Tests must be conducted 1n California which 1s the only state where this use Is permitted.
-------
63
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.240 Residue Chemistry - Footnotes (cont'd)
23/ Currently, the nature of the residue In animals Is not adequately understood. On receipt of the data requested
1n the section entitled "Nature of the Residue 1n Animals," the appropriate nature of tolerances for residues In
animal products will be determined and, with consideration for any newly found metabolites of toxlcologlcal
concern, the adequacy of the available data regarding the magnitude of the residue 1n fat, meat, and meat
byproducts of cattle, hogs, poultry and milk will be determined.
24/ Data must be submitted depicting the nature and magnitude of the residue In raw water following treatment of
various bodies of water (I.e., lakes, ponds, marshes, etc.) with multiple applications (at 21-day Intervals) of
each of the following: (1) an RTU formulation at 1.5 ga. finished spray/A; (11) a D and G formulation (In separate
tests) at 0.2 Ib al/A; and (111) an EC formulation at 0.05 Ib ai/A. Degradation products In water should be
Identified and quantified. Should detectable residues of concern occur In water, then tolerance proposals for
Irrigated crops as well as an estimated appropriate level In water will be required. In 11eu of submitting data
the following label restriction may be Implemented: Broadcast use over aquatic areas which Include drainage
ditches, stagnant and standing water and Intermittently flooded areas around other bodies of water. Application
may not be made around bodies of water where fish or shellfish are grown and/or harvested commercially.
if detectable residues of concern are found 1n water then residue and metabolism studies 1n fish will be required.
Since the present use sites Include tidal areas, a residue study with shellfish ( a mollusk and a crustacean) will
also be required. In lieu of submitting data the following label restriction may be Implemented: Broadcast use
over aquatic areas which Include drainage ditches, stagnant and standing water and Intermittently flooded areas
around other bodies of water. Application may not be made around bodies of water where fish or shellfish are
grown and/or harvested commercially.
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64
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
B1 bl 1 ograpM c T1 mef rame
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission1/
Data Requirement
Sec. 158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Mater
161-3 - On Soil
161-4 - In Air
Metabolism studies - Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
PAIRA
PAIRA
PAIRA OR TGAI
PAIRA OR TGAI
PAIRA OR TGAI
PAIRA OR TGAI
PAIRA OR TGAI
A B C D G H
A B C D G H
A B G
A B
No
A B G H
ABC
C D G
C D
Yes
Yes
No
No
Yes
Yes 401104012/ Reserved3/
No Yes
No Yes
Yes 00114318
No
Yes
Yes
9 Months
06/19/87
9 Months
9 Months
12/20/88
12/20/88
-------
65
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Sec. 158.290 Environmental Fate
Mobility Studies
163-1 - Leaching and
Adsorptl on/
Desorptlon
163-2 - Volatility (Lab)
ICO t U*tl«*414*>< /C*J*>1
-------
66
TABLE
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec.
Data Requirement
158.290 Environmental Fate
Test
Substance
(continued)
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Tlmeframe
for
Submission1/
Accumulation Studies
165-1
165-2
165-3
165-4
165-5
Sec.
132-1
132-2
132-3
132-4
- Rotational Crops
(Confined)
- Rotational Crops
(Field)
- Irrigated Crops
- In Fish
- In Aquatic Non target
Organism
158.390 Reentry Protection
- Foliar Dissipation
- Soil Dissipation
- Dermal Exposure
- Inhalation Exposure
PAIRA
TEP
TEP
PAIRA OR TGAI
TEP
TEP
TEP
TEP
TEP
ABC
ABC
C D
A B C D G
D G
B
N/A
B
B
No
No
No
No
No
No
No
No
No
Yes
Reserved9/
fes
Yes10/
Reserved11/
Yes"/
No
Optional13/
Optional13/
39 Months
—
39 Months
12 Months
—
27 Months
—
—
—
Sec. 158.440 Spray Drift
201-1
202-1
- Droplet Size Spectrum
- Drift Field Evaluation
TEP
TEP
A B C D G H
A B C D G H
No
No
Yes14/
Yes14/
12 Months
12 Months
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67
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.290 Environmental Fate - Footnotes
Sec. 158.390 Reentry Protection - Footnotes
Sec. 158.440 Spray Drift - Footnotes
Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Data Call-in Letter
dated April 29, 1986.
Data have been received but have not completed the Agency's review process. Therefore, no determination can be
made at this time as to the adequacy of the data In meeting this data requirement.
3/ If, at the conclusion of Agency's data review process, the data 1s found unacceptable a new study will be required
under Section 3(c)(2){B) of FIFRA.
V Studies on three other soils are required. At least one of these studies should be an aged column leaching study
(preferably on sandy loam soil) with adequate Identification of soil and leachate residues. The other studies
should be unaged adsorptfon/desorptfon with Kj values determined.
5/ Field volatility requirement Is reserved pending receipt and evaluation of acceptable laboratory volatility data. If
required, the field volatility study will be due within 15 months after notification of requirement by the Agency.
6/ Method sensitivity should be about 10 ppb for soil. The degradates Identified In the metabolism studies should be
monitored, Including 3-methyl-4-(methylsulfonyl)-phenol and 3-methyl-4-(methylsulflnyl)-phenol.
?/ Combination and tank mixes are not being addressed 1n this Standard.
8/ Long-term field dissipation data requirement 1s deferred pending receipt of acceptable field dissipation
data (164-1). If required, the long-term field dissipation study will be due within 50 months after
notification of the requirement by the Agency.
-------
68
•
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.290 Environmental Fate - Footnotes (continued)
Sec. 158.390 Reentry Protection - Footnotes
Sec. 158.440 Spray Drift - Footnotes
9/ Field crop rotation data requirement Is deferred pending receipt of acceptable confined rotational crop
accumulation data. If required, the field crop rotation study will be due within 50 months after notification
of the requirement by the Agency.
10/ The registrant should first submit an octanol/water partition coefficient.
U/ Aquatic non-target organism data requirement Is reserved pending the results of the laboratory studies of
pesticide accumulation In fish (165-4). If required, the aquatic non-target organism pesticide accumulation
study will be due within 12 months after notification of the requirement by the Agency.
12/ For ornamental use patterns, the registrant Is required to propose an acceptable reentry Interval based either upon
data: (1) on dissipation of residues (decline curve), on human exposure to those residues, and on toxlclty of the
residues or (11) on determination of that time beyond which there are no detectable dlslodgeable or Inhalable residues
remaining In the worker environment.
13/ Human exposure monitoring data may be submitted at the registrant's option. If dermal exf, -sure data are submlted,
Inhalation exposure data must also be submitted.
The spray drift droplet spectrum and field evaluation may be done together In order to evaluate the drop spectra
that are associated with actual field-use patterns.
-------
69
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
81-2 - Acute Dermal - Rat
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation -
Rabbit
81-6 - Dermal Sensltlzatlon -
Guinea Pig
81-7 - Acute Delayed
Neurotoxlclty - Hen
Subchronlc Testing
82-1 - 90-Day Feeding -
- Rodent
- Nonrodent
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A B C D G
A B C D G
A B C D G
A B C D G
A B C D G
A B C D G
A B C D G
A B C D G
A B C D G
Does EPA
Have Data?
I Yes
I Yes
I Yes
I Yes
I Yes
I Yes
I Yes
I No
I No
Bibliographic
Citation
(MRID)
00132312
401867042/
00132314
401867052/
00132317,,
401867072/
00132319
4018670842
00132319
401867092/
401867102/
402292012/
Must Additional
Data Be Submitted?
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Yes4/
Yes4/
Tlmeframe
for
Submission*/
06/19/87
06/19/87
06/:.9/8
06/19/6.
06/19/87
06/19/87
09/22/87
03/20/88
12/20/87
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70
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Sec. 158.340 Toxicology (cont'd)
Subchronlc Testing (cont'd)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxldty
Chronic Testing
83-1 - Chronic Toxlclty -
- Rodent
- Nonrodent
83-2 - Oncogen1c1ty -
- Rat
- Mouse
Test
Substance
TGAI
TPAT
luAi
TGAI
TPAT
IbAl
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A B C D G
AR p n £
D l> U U
A B C D G
An p n a
o l» U u
A B C D G
A B C D G
A B C D G
A B C D G
Does EPA
Have Data?
I Yes
T Kin
1 NO
I No
T Mn
1 NU
I No
I Partial
I No
I No
Bibliographic
Citation
(MRID)
403295012/
00081363,
00132341,
00132356,
00147245
Must Additional
Data Be Submitted?
Reserved3/
Mn
NO
Yes5/
DacopUAftO /
l\CdC* TCU /
Yes?/
Yes7/
Yes7/
Yes7/
Tlmeframe
for
Submission1/
09/22/87
15 Months
11/20/90
11/20/90
11/20/90
11/20/90
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71
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission1/
Data Requirement
Sec. 158.340 Toxicology (cont'd)
Chronic Testing (cont'd)
83-3 - Teratogenldty -
- Rat
- Rabbit
83-4 - Reproduction -
-Rat or Mouse
Mutagenlclty Testing
84-2 - Gene Mutation
84-2 - Chromosome Aberration
84-2 - Other Mechanism of
Mutagenlclty
TGAI
TGAI
TGAI
TGAI
A B C D G I
Yes 00132346 Reserved3/ 12/21/87
403294012/
A B C D G I Yes 00132347, No
404627014/
A B C D G I
Partial 00081115,
00132344
Yesfy
TGAI
TGAI
A B C D G I Yes 00132349
A B C D G I Yes 00132348
00132349
00132350
00132351
00132352
00132353
No
No
A B C D G I
Yes
00147316
No
12/28/89
-------
72
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission1/
Data Requlrenent
Sec. 158.340 Toxicology (confd)
Special Testing
85-1 - General Metabolism
85-2 - Dermal Penetration
PAI or PAIRA
PAI or PAIRA
A B C D G I Yes 001159262/ Reserved3/ 04/26/88
001163962/
001323092/
001549672/
A B C D G I
No
No
Special Testing Ocular Effects
- Acute Oral - Rat TGAI
- Subchronlc Oral - Rat TGAI
- Six-Month Oral - Dog or TGAI
Rabbit or Monkey
A B C D G I No
A B C D G I No
A B C D G I No
Yes'/
Yes*1/
9 Months
15 Months
9 Months
-------
73
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.340 Toxicology - Footnotes
V Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Data Call-in Letter
dated April 29, 1986.
2/ Data have been received but have not completed the Agency's review process. Therefore, no determination can be
made at this time as to the adequacy of the data In meeting this data requirement.
V If, at the conclusion of Agency's data review process, the data 1s found unacceptable a new study will be required
under Section 3(c)(2)(B) of FIFRA.
V Subchronlc feeding studies are not required 1f chronic feeding studies are conducted.
5/ A subchronlc Inhalation test Is required 1f use of fenthlon results 1n repeat Inhalation exposure at levels
likely to be toxic.
6/ Requirement Is contingent upon results of the acute delayed neurotoxlclty study 1n hens. If required, the study
will be due within 15 months after notification of requirement by the Agency.
?/ Registrants who conduct chronic feeding and/or oncogenlclty studies should Inform the Agency In writing .f the
dosage levels planned and their reasons for believing that the highest dose approaches or equals the Ma,.,mum
Tolerated Dose observed In subchronlc or range-finding studies, and must also consult with the Agency to determine
that the appropriate dosage levels are being used In the chronic feeding and/or oncogenlclty studies. If EPA
subsequently determines that the study was conducted using a dosage rate that was too low to assess long-term
effects, the study may be deemed not to satisfy the data requirement.
8/ Either the raw data from the existing study must be submitted to remedy Its deficiencies or a new multl-generation
reproduction study 1s required.
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74
TABLE A
GENERIC DATA REQUIREMENTS FOR FE NTH I ON
Sec. 158.340 Toxicology - Footnotes (cont'd)
9/ Acute Tests 1n Rats: (Recommended; acute sublethal doses; tests performed pretest, at 4 days and repeated at
intervals until run recovery). Observations should Include:
- chollnesterase activity (blood); and
- retinal electrical activity (electroretlnograpny).
10/ Subchronlc Study 1n Rats: (Recommended; 3 orally treated and 1 control group, 10 rats/sex/group. Observations
pretest ana at^ intervals for at least 90 days; doses based on results of acute study). Observations should Include:
- chollnesterase activity (blood* brain at termination);
- retinal electrical activity (electroretlnography);
- opthalmoscoplc observations;
- fundis observations/photographs;
- clinical observations of potential chollnerglc signs;
- body weights; and
- hlstopathology of the eye; light and EM, Including Intra- and extraocular muscle, optic
nerve and retina.
Nonrodent (Dog/Rabbit/Monkey) Study: (Recommended; 3 orally treated and 1 control group, 5 animal s/sex/group.
Observations pretest and at Intervals ror at least 6 months). Observations should Include:
- chollnesterase activity (RBC, plasma; at termination brain, oculomotor muscle, retina);
- retinal electrical activity {electroretlnography);
- corneal sensitivity;
- slit lamp blomlcroscoplc examinations;
- corneal thickness;
- corneal curvature;
- op thai moscopic /fundis observations/photographs;
- Intraocular pressure;
- refractlvlty of cornea and lens;
• clinical observations of potential ehollnerglc signs;
- body weights; and
- hlstopathology of the eye; light and EM, Including Intra- and extraocular muscle, optic
nerve and retina.
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75
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Substance1/ Patterns Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.490 Wildlife and Aquatic
Avian
71-1
71-2
71-3
organi sms
And Mammalian Testing
- Avian Acute Oral
Toxlclty
- Avian Subacute Dietary
Toxidty
- Waterfowl
- Upland Game Bird
- Wild Mammal Toxlclty
TGAI
Degradate
TGAI
Degradate
TGAI
Degradate
TGAI
A B C D G H [I]3/ Yes
A [B]5/ C D G [I]6/ No
A B C D G H [I]8/ Yes
A [B]5/ C D G [I]6/ No
A B C D G H [I]8/ Yes
A [B]5/ COG [I]6/ No
A [B]9/ C [D]1°/G No
00160000
05000975
401867014/
00062189,
401867034/
00062189,
401867024/
No
Yes7/
No
Yes7/
No
Yes7/
Yes11/
06/19/87
9 Months
06/19/87
9 Months
06/19/87
9 Months
24 Months
L M •* _ A *_
Degradate
A [B]9/ C [D]10/G No
12-Month
Progress Report)
Yes12/ 24 Months
{12-Month
Progress Report)
-------
76
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Test
Substance1/
Bibliographic Timeframe
Use Does EPA Citation Must Additional for
Patterns Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.490 Wildlife and Aquatic
organisms iconfoj
Avian And Mammalian Testing (cont'd)
71-4 - Avian Reproduction
- Waterfowl TGAI
71-5
- Upland Game Bird
Simulated and Actual
Field Testing for
Mammals and Birds
Degradate
TGAI
Degradate
TEP
A [B]13/ C D G No
[I]"/
A [B113/[C]14/D G No
[I]lS/
[BJ13/ COG No
A [B]13/[C]14/G No
A [BJ5/C D G
[I]6/
Partial 00107081*
00116380*
40247101*
40247102*
40247104*
Yes"/
Reserved16/
Yes14/
Reserved16/
24 Months
(12-Month
Progress Report)
24 Months
(IP-Month
Progress Report)
Yes17/,18/ 48 Months
(Protocols
6 Months)
(Annual
Progress Reports
each 12 months)
-------
77
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Test Use
Data Requirement Substance1/ Patterns
Sec. 158.490 Wildlife and Aquatic
organisms iconra)
Aquatic Organisms Testing
72-1 - Freshwater Fish Acute
Toxlclty
- Warmwater TGAI
TEP
Degradate
- Coldwater TGAI
TEP
Degradate
72-2 - Acute Toxlclty to Fresh-
water Invertebrates TGAI
TEP
n& ^m^e± .J** ^4t
A B C D G H
C D
A [B]9/ C D
A B C D G H
C D G
A [B]9/ C D
[I]6/
A B C D G H
C D G
A rni9/ r n
Bibliographic Tlmefranie
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
[I]19/ Yes
Partial
G [I]6/ No
[I] I9/ Yes
Partial
G No
I Yes
Partial
P Un
05000819 No
05014941
402741014/
4009460220/ Yes21/
Yes22/
40094602, No
402142014/
4009460220/ Yes21/
Yes*
40094602 No
40246401
4009460220/ Yes21/
Daea*>uaH£
-------
78
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Data Requirement
Test
Substance1/
Bibliographic
Use Does EPA Citation Must Additional
Patterns Have Data? (HRID) Data Be Submitted?
Tlmeframe
for 9
Submission^/
Sec. 158.490 Wildlife and Aquatic Organisms (cont'd)
Aquatic Organisms Testing (cont'd)
72-3 - Acute Toxlclty to
Estuarlne and Marine
Organlsms TGAI
TEP
Degradate
72-4 - F1sh Early Life Stage
and Aquatic Invertebrate
Life Cycle
72-5 - Fish Life Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing
TGAI
Degradate
TGAI
TGAI
TEP
[A]9/ [B]17/D G Partial
D G Partial
[A]9/ [B]9/ D G No
A [B]9/ C D G
A [B]9/ C D G
A [B]9/ C D G
A [B]9/ C D G
[I]6/
A [B]9/ C D G
G [I]6/
Yes
No
No
No
Partial
4024710524/ Reserved26/
4022840125/
405641014/
404955014/
4009460220/ Yes21/
Reserved23/
405641024/ Reserved27/
Reserved28/
Reserved28/
Yes29/
00107081*
00116380*
00154963
40247103*
09/22/87
12 Months
01/22/88
12 Months
09/22/90
-------
79
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Data Requirement Substance1/ Patterns Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.490 Wildlife and Aquatic Organisms (cont'd)
70-1 - Special Testing
- Residue Monitoring TEP I
- Bivalve Testing TGAI A B C D G
- Reptile and Amphibian TGAI A B D G
Testing
Sec. 158.540 Plant Protection Testing
122-1 - Seed Germination/
Seedling Emergence TGAI [B]32/D G
- Vegetative Vigor TGAI [B]32/D G
122-2 - Aquatic Plant Growth TGAI [B]32/D G
No
No
No
Yes 401104024/
Yes 401104024/
Yes 4018671 I4/
401867124/
401867134/
401867144/
401867154/
Yes31/,3-
Yes34/
Yes35/
Reserved4/
Reserved4/
Reserved4/
/ 48 Months
(Protocol
6 Months)
(12-Month
Progress Report)
18 Months
(Protocol
6 Months)
18 Months
(Protocol
6 Months)
06/19/87
06/19/87
06/19/87
-------
80
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158*490 Wildlife and Aquatic Organisms - Footnotes
sec. 158.5W Plant protection Testing - Footnotes
* Could fulfill requirement In conjunction with other test data.
i/Degradate « Major degradates of fenthlon; 3-methyl-4-(methylsulfonyl)-phenol and 3-methyl-4-(methylsulflnyl)-phenol.
2/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Data Call-In Letter
dated April 29. 1986.
3/The use of fenthlon on livestock Is categorized as an Indoor use; however, exposure to birds 1s possible. Therefore, a
study Is required for products registered for direct application on cattle and swine. Also required for manufacturing
use products which, as a technical, are solids and used to formulate all products registered for Indoor use.
4/Data have been received but have not completed the Agency's review process. Therefore, no determination can be made at
this time as to the adequacy of the data In meeting this data requirement.
^/Required only to support registrations of those formulations used to control mosquitoes and to control birds In
Industrial areas.
6/Requ1red only to support registration of those formulations that are applied directly to cattle or swine.
7/Requ1red because of series of bird kills reported by Hanson and Howell (1981) suggest that magpies were killed by feeding
on backs of cattle; In some cases, several weeks after the livestock had been treated. Since available Information
Indicates fenthlon has a relatively short half-life, It Is possible that some degradate Is toxic to birds. One avlan
dietary study must be conducted with either an upland species or a waterfowl, major degradates of fenthlon (see note
No. 1).
8/Requ1red to support registration of those formulations that are applied directly to cattle or swine. Also, one avlan
dietary test Is required with either an upland species or a waterfowl to support all registered manufacturing-use
products used to make any Indoor formulation.
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81
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.490 Wildlife and Aquatic Organisms - Footnotes (cont'd)
sec. ibH.bw Plant protection testing - Footnotes fcont'd)
9/ Required only to support registration of those formulations used for mosquito control.
^/Required only to support registration of nongranular formulations.
U/The use of fenthlon Is suspected of killing mammals (Deweese et al. 1981, MRID No. 40247101). Acute toxlclty
testing Is required to determine the toxlclty of fenthlon to mammals.
12/The use of fenthlon Is suspected of killing mammals following application at rates that would not have been
expected to cause residues lethal to mammals (Deweese et al. 1981, MRID No. 40247101). It is possible that a
degradate 1s toxic to mammals. Acute toxlclty testing 1s required to determine the toxlclty of fenthlon
degradates (see footnote No. 1) to mammals.
l3/Requ1red to support registrations of all mosquito control formulations that Involve multiple applications per
season. Also required for formulations used to control birds because bird perches are maintained regularly for
continuous control and, subsequently, extended exposure to nontarget birds.
l4/Requ1red because multiple applications are permitted.
l5/Requ1red to support registration of those formulations that are applied directly to cattle or swine because
Incidents reported by Hanson and Howell (1981) Indicate toxic effects occur for several weeks after treatment,
suggesting chronic exposure.
16/Reserved pending receipt of avlan acute and dietary test results with degradates.
17/The available field tests do not fulfill the requirements for definitive field studies. They do not provide
quantitative Information on the effects of fenthlon on birds and mammals.
18/Terrestrlal Field Studies ff ^ ^ A ... . mc
The use of tenth Ion on the following sites has been determined to cause adverse effects to terrestrial organisms.
The following chart Indicates the types of terrestrial field studies required for each use site per category. The
terms used to describe the types of studies are:
a. Preliminary field study, which Is a multlslte. multllocatlon screening study to detect acute effects to mammals
and/or birds. Hultlslte means several (8) treatment and sampling areas within each location. Location refers
-------
82
TABLE A
GENERIC DATA REQUIREMENTS FOR FE NTH I ON
Sec. 158.490 Wildlife and Aquatic Organisms - Footnotes (cont'd)
sec. ibH.sw Plant protection Testing - Footnotes fcorft'd)
to geographically or ecologically distinct portions of the range where fenthlon Is applied for each particular
use site (e.g., pasture! and mosquito control or bird control around manmade structures). The results of these
preliminary screening studies will be used to determine the need for definitive avlan and/or mammalian field
studies. The Agency can provide guidance for developing such studies.
b. Definitive field study, which Is a multlyear, multllocatlon study to quantify the effects of the particular use,
in tnis case, exposed avlan species. This would Involve studying several species with various censuslng and
population measuring techniques for several years to determine the extent of effects that have already been
demonstrated In preliminary type studies and Incident reports.
Aquatic Studies
Aquatic mesocosm studies are required for the Identified sites because of concern for hazard to aquatic organism
and fish. Aquatic mesocosm studies are field studies Incorporating multiple treatment ponds of similar size and
characteristics and multiple treatment rates. Effects to the aquatic community will be determined by measuring the
difference In success and development of biota 1n treatment ponds to control ponds.
Site
Cat. Use Site Use Type of Field Study Required
A (TERRESTRIAL FOOD)
Pastures Mosquito and other pest Preliminary mammalian study
control Definitive avlan study
Aquatic mesocosm study
B (TERRESTRIAL NONFOOD)
Nonagrl cultural areas Mosquito control Preliminary mammalian study
Definitive avlan study
Aquatic mesocosm study
Manmade structures Bird control Preliminary avlan study
-------
83
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.490 H1
-------
84
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.490 Wildlife and Aquatic Organisms - Footnotes (cont'd)
sec. 15B.5W Plant protection Testing - Footnotes fcont'd)
19/Requlred to support registration of those formulations that are applied directly on cattle or swine because
livestock may be expected to move Into waterways after being treated. Also, a test with either a coldwater
or warmwater species Is required to support manufacturing-use products used to make Indoor formulations.
?°/All studies were conducted with either a 46% or 47.5% a1 formulation. The Inerts were not Identified.
^/Formulation testing Is required of all nongranular formulations that are applied directly to water. Formulations
of similar percent active Ingredient and similar Inerts/other actives may be represented by one such formulation.
The following are the nongranular formulations applied directly to water. Testing one representative formulation
from each group 1s acceptable.
Group Registration No. Formulation Use Site
1 5011-74 2.5% RTU Aquatic nonfood
1 5011-92 1.0% RTU Aquatic nonfood
1 10088-18 1.0% RTU Aquatic nonfood
2 400-226 1.0% Dust Aquatic nonfood
3 3125-73 25.3% EC* Aquatic nonfood
3 904-384 25.0% SC/L Aquatic nonfood
4 3125-148 9.67 lb/gal** Aquatic food (rice)
*Also Identified 1n Listing of Registered Pesticide Products as 4 lb/gal, Confidential Statement of Formula
Indicated that this Is a 50.9% al formulation. In either case, It still may be represented by, or represent,
group 3.
**If this formulation Is greater than 90% active Ingredient, 1t does not need to be tested as a formulated product.
22/F1eld testing Indicated that fish were killed by an application to water that should not have caused concentrations
lethal to fish. It Is possible that a degradate 1s more toxic than fenthlon. Acute tests with either a coldwater
or a warmwater species must be conducted using major degradates (see footnote No. 1).
23/Reserved pending results of freshwater fish tests using major degradates of fenthlon (see footnote No. 1).
24/Part1ally fulfills requirement for estuarlne fish test; fulfills requirement for shrimp test.
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85
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.490 Wildlife and Aquatic Organisms - Footnotes (cont'd)
sec. iw.wj Plant protection Testing - t-ootnotes Tcorft'd)
25/Part1ally fulfills requirement for estuaHne fish test; fulfills requirement for shrimp and oyster tests.
26/Estuar1ne Fish 96-hour test required.
27/F1sh early life stage and aquatic Invertebrate life cycle test required because uses Involve multiple
applications.
23/May be required depending on results of other tests because multiple applications/treatments permitted.
29/Requ1red unless the fish accumulation test, normally required under Section 158.290 Environmental Fate,
1s provided.
30/The available field tests do not fulfill the requirements for quantitative field studies with aquatic and
estuarlne organisms.
31/Recause of the potential for treated livestock to enter and contaminate ponds, rivers, and streams, residue
monitoring Is required. This Involves choosing at least eight sites where cattle are being treated and
where these cattle can move Into a natural waterway. Waterways must be representative of those used by
cattle, Including large ponds, streams, and rivers. Treatment must be at maximum label rates; number .f
animals treated must be typical of large-scale farming operations. Within 6 hours after treatment, cattle
must be herded Into the waterway that 1s to be sampled. Waterway must be at least 5 feet deep and cattle
must be permitted to move about freely once they enter the water. Water must be sampled as soon as cattle
enter and sampling must continue for at least 1 month. Samples In rivers or streams must also be collected
at several stations downstream, as well as at the point where the cattle are wading. Samples In ponds must
be from pond center as well as In shallower parts. The reglstrant(s) must submit a protocol for this
monitoring program within 6 months from the date of this standard.
32/Requ1red to support registration of those formulations used to control mosquitoes and formulations registered
for use on ornamentals.
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86
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.490 Wildlife and Aquatic Organisms - Footnotes (cont'd)
sec. 15B.5W Plant protection Testing - Footnotes [corft'd)
33/Stud1es to determine persistence of fenthlon and major degradates on livestock. This would Include field
residue monitoring of material collected from the back of treated livestock. Material to be sampled should
Include hair pulled (not cut) from the treated area, and Insects that may be present. This material should
be analyzed for fenthlon and Its major degradates or metabolites. Sampling should be collected dally for the
first week, and then weekly for at least 100 days. A treated cow and pig should be sacrificed to determine
residues In various parts of their body at various times (0-day, 1 week, and 1 month) following treatment.
These parts should Include back skin, various Internal organs, fat, and muscle. The purpose of these studies
Is to Identify the degradates/metabolltes present In various materials associated with livestock treatment, and
to determine the levels of these chemicals and their persistence.
3*/Bas1c toxlclty testing on freshwater bivalves and their glochldla. This would involve testing freshwater
species that would be Indicative of endangered mussels. The Agency Is requesting additional guidance from
the Fish and Wildlife Service on how these tests should be designed. Registrants are encourage to submit a
protocol before Initiating any testing.
35/Bas1c toxlclty tests on reptiles and amphibians. All amphibian Hfestages should be studied. The tested
species should be representative of endangered species that could be exposed to fenthlon. The Agency 1s
requesting further guidance from the Fish and Wildlife Service on how these test should be designed and
recommends that registrants submit protocols before Initiating the tests.
-------
87
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Bibliographic Tlmeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission1/
Data Requirement
Sec. 158.590 Nontarget Insects
NONTARGET INSECT TESTING - POLLINATORS
141-1 - Honeybee Acute Contact
Toxlclty TGAI A B
141-2 - Honeybee - Toxlclty of
Residues on Foliage TEP A B
141-4 - Honeybee Subacute
Feeding Study Reserved3/ —
141-5 - Field Testing for
Pollinators TEP A B
NONTARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxlclty to
Aquatic Insects
142-2 - Aquatic Insect
Life-cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
Reserved5/
Reserved5/
Reserved5/
NONTARGET INSECT TESTING - PREDATORS AND PARASITES
143-1
thru
143-3 -
Reserved5/
Yes
No
00036935
No
Yes*/
15 Months
No
No4/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENTHION
Sec. 158.590 Non target Insects - Footnotes
dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Data Call-In Letter dated
April 29, 1986.
2/Resldual toxlelty data are required because data from the acute test Indicate high toxlclty.
3 /Reserved pending development of test methodology.
VData reviewed to date do not Indicate the need for field testing.
^/Reserved pending Agency decision as to whether the data requirement should be established.
-------
89
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTHION
Data Requirement
Test Use
Substance1/ Patterns
Bibliographic Tlmeframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Part 158, Subpart C, Product Chemistry
Product Identity and Composition
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of Starting
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Product ingredients"
62-1 - Preliminary Analysis
of Product Samples
62-2 - Certification of
Ingredient Limits
62-3 - Analytical Methods
to Verify Certified
Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
HP
HP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
Yes
Yes
Yes
No
No
No
No
Yes
40085801 Reserved3/,4/ 03/21/87
40085801 Reserved3/,5/ 03/21/87
40085801 Reserved3/.6/ 03/21/87
Yes7/ 09/22/87
Ves8/ 09/22/87
Yes9/ 09/22/87
Yes10/ 03/21/87
40085802 Reserved3/,!0/ 03/21/87
-------
90
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTH ION
Data Requirement
Test Use
Substance1/ Patterns
Does EPA
Have Data?
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Tlmeframe
for
Submission2/
Part 158, Subpart C, Product Chemistry (cont'd)
Physical and Chemical
Characteristics icont'd)
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
- Odor
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Actl on
- FlammablHty
- ExplodablHty
- Storage Stability
- Viscosity
- Mlsclblllty
- Corrosion Characteristics
Requirements:
«* • t *_ *_ _ ^ _ & ^ _. ^ — _
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
11 /A
All
All
All
All
All
All
All
All
All
All
U/A
No
Yes
No
No
No
No
Yes
Yes
No
Yes
M/A
Yes10/
40085802 Reserved3/,10/
Yes11/
Yes12/
Yel13/
Yes1*/
40085802 Reserved3/,10/
40085802 Reserved3/, i5/
Yes10/1*/
40085802 Reserved3/,10/
M/A Mnl7/
03/21/87
03/21/87
03/21/87
03/21/87
03/21/87
03/21/87
12/21/87
03/21/87
9 Months
12/21/87
-------
91
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTHION
Part 158, Subpart C, Product Chemistry - Footnotes
Test Substance: MP - Manufacturing-Use Product (Formulation Intermediates (FI) are also Included In the category
of manufacturing-use products). The 95% (EPA Reg. No. 11556-36),93* EC (EPA Reg. No. 3125-148), 93% (EPA Reg. No.
3125-197), 10% FI (EPA Reg. Nn. 655-371) amd 20% FI (EPA Reg. No. 655-372) are considered MPs.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Comprehensive Data
Call-in letter dated April 29, 1986.
3/ Data submitted In response to the April 29, 1986 Comprehensive Data Call-in letter were not received In time to be
Included In the data base reviewed for this standard. Therefore no determination has been made as to the adequacy
of this data 1n satisfying the data requirement. Should the data be found unacceptable after Agency review a new
study Is required under Section 3(c)(2)(B) of FIFRA.
V 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, and
purpose of the active Ingredient and each intentionally added Inert must be provided. For the active Ingredients,
the following must also be provided: the product, common, and trade names; the molecular, structural, and empirical
formulas; the molecular weight or weight range; and any experimental or Internally assigned company code numbers.
V Complete Information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of starting materials and the order 1n 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 starting material must be provided, along with
Information regarding the properties of those materials.
6/ A detailed discussion of all Impurities that are or may be present at >0.1%, based on knowledge of the starting
materials, chemical reactions (Intended and side) In the manufacturing process, and any contamination during and
after production must be submitted.
7/ 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.
-------
92
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTHION
Part 158, Subpart C, Product Chemistry - Footnotes (continued)
8/ Upper and lower limits for the active Ingredient and each Intentionally added Inert, and upper limits for each
Impurity present at >0.1% (w/w) and each "toxlcologlcally significant" Impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. Limits for Impurities not associated with the active Ingredient need be provided only If
they are considered to be of toxlcologlcal significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
9/ Analytical methods must be provided to determine the active Ingredient, and each toxlcologlcally significant
Impurity and Intentionally added Inert for which certified limits are required. Each method must be accompanied
by validation studies Indicating Its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
Physlcochenrfcal characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required In
40 CFR 158.120 and more fully described In the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
Data required If the test substance Is dlsperslble In water.
12/ Data required If the product contains an oxidizing or reducing agent.
13/ Data required If the product contains combustible liquids.
14/ Data required If the product Is potentially explosive.
15/ Data required 1f the product Is a liquid.
I6/ Data required If the product Is a liquid and 1s to be diluted with petroleum solvents.
17/ If samples are needed, the Agency will request them.
-------
93
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTHION
Sec.
Data Requirement
158.340 Toxicology
Test
Substance1/
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
(MRID)
Must Additional
Data Be Submitted?
Tlmeframe
for
Submission2/
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal - Rat
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sensltlzatlon -
Guinea Pig
- Acute Delayed
MP
HP
MP
MP
MP
MP
MP
ABC
ABC
ABC
ABC
ABC
ABC
ABC
D G
D G
D G
D G
D G
D E
D E
I Yes
I Yes
I Yes
I Yes
I Yes
Yes
Yes
00132312
40186704
00132314
40186705
00132317
40186706
40186707
00132319
40186708
00132319
40186709
40186710
40229201
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
06/19/87
06/19/87
06/19/8V
06/19/8V
06/19/87
06/19/87
09/22/87
Neurotoxldty - Hen
-------
94
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENTHION
sec. 158.3W roxicoiogy - i-ootnotes" "
V Test material: MP = Manufacturing-Use Product (Formulation Intermediates are also Included In the category of
manufacturing-use products).
2/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated by calendar dates determined from the date of Issuance of the Agency's Comprehensive Data
Data Call-In letter dated April 29, 1986.
3/ If at the conclusion of the Agency's review the data 1s found unacceptable a new study will be required under
Section 3(c)(2)(B) of FIFRA.
-------
95
II. LABELING APPENDICES
-------
96
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This 1s
referred to as format 1abellIng. 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 1n
the upper part of the panel. The name of a product will not be
accepted If ft 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 1s the bottom of the front panel Immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed 1n the largest suitable
unit, e.g., "1 pound 10 ounces" rather than "26 ounces." In
addition to English units, net contents may be expressed 1n
metric units. [40 CFR 162.10(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 Reg. No."
The registration number must be set In type of a size and style
similar to other print on that part of the label on which 1t
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 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." 1s the final estab-
ment at which the product was produced, and may appear 1n any
suitable location on the label or Immediate container. It must
also appear on the wrapper or outside container of the package 1f
the EPA establishment number on the Immediate container cannot be
clearly read through such wrapper or container.
[40 CFR 162.10(f)J
-------
97
SUMMARY-2
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 CFR 162.10(g)]
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 ot 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 lb 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.
L40 CFR I62.l0(h)(l)(11 )J
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) Is required on the front panel Immediately below the
child hazard warning statement. L4UCFR 162.10(h)(l) (1) J
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxldty Category I on the basis of oral, dermal, or
Inhalation toxldty, 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. L40 CFR 162.10(h)(1)(1)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products In toxldty Categories I, II, and
III. L40 CFR I62.l0(h)(l)(111)J
-------
98
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" Is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
L40 CFR I62.l0(h)(l)(111 )J
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 1t 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. L40 CFR 162. 10(h ) ( 2) J
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. L4U CFR 16Z.10(h ) (2) (1 ) J
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. L40 CFR 162.10(h )(2) (11 ) J
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
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 1s based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. ihese
statements are to be located 1n the side/back panel precautionary
statements section, preceded by the heading "Physical /Cheml ca I
Hazards." Note that no signal word Is used In conjunction with
the flammablllty statements.
Item 9A. RESIRICIED USE CLASSIFICATION - FIFRA 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 nay 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.
-------
99
SUMMARY-4
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 rereglstratlon. During the
Agency's review of your application, your proposed classification
determination will be evaluated 1n accordance with the provisions
of 40 CFR 162.11U). You will be notified of the Agency's
classification decision.
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 CFR 162.10(h)(l)(1v).
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 1n Section I). If use 1s 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 nay label the product for Restricted use. 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.
-------
100
SUMMARY-5
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
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It 1s 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.
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 may be required 1n
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 Disposal" 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, S10R,
PEST/DIS, and CONl/DIS to determine the storage and disposal
Instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated 1n terms which can be easily read and understood by the
average person likely to sue 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. L40 CFR 162.10J
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 may not bear claims or
representations that differ 1n substance from those accepted 1n
connection with registration of the product. It should be made
part of the response to this notice and submitted for review.
-------
101
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
Z
3
4
5
6A
t>B
7
7A
7B
LABEL ELEMENT
product name
company name
and address
Net contents
EPA Reg. NO.
EPA ESt. NO.
ingredients
statement
pounds/gai ion
statement
Front panel
precautionary
statements
Keep out or Reach
of Children
(Child hazard
warning)
signal word
i
APPLICABILITY
OF REQUIREMENT
AI I products
All products
All products
All products
All products
AM products
Liquid products
where dosage Is
given as Ibs.
a1/un1t area
All products
All products
Al I products
I
PLAULMtNl
REQUIRED
front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
UN LABLL
PREFERRED
center front
Sane)
ottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
Immediately
before or
following
Reg. No.
immediately
f ol 1 owl ng
product name
Directly below
the main
Ingredients
statement
Above signal
word
immediately
below child
hazard
warnl ng
COMMENTS
if registrant is not tne producer, must
be qualified by "Packed for . . .,"
"Distributed by . . .," etc.
May be m metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other type.
nay appear on tne container instead or
the label.
Text must run parallel with otner text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
•^Note type size requirements.
-------
102
SUHHARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (cont'd)
ITEM
/C
7D
/E
8
BA
SB
LABEL ELEMENT
5Ku i i a cross-
bones and word
POISON (In red)
statement or
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
i
1 PLACEMENT
REQUIRED
Front panel
category i:
Front panel
unless refer-
ral statement
Is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None '
ON LABEL -
PREFERRED
BOW 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 aoove '
COMMENTS
nust be grouped under neaaings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
103
SUMMARY-8
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (conf d)
ITEM
BC
9A
9B
1UA
1UB
1UC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
storage ana
disposal block
Directions
for use
! APPLICABILITY
! OF REQUIREMENT
iAii pressurized
{products, others
Swlth flash
! points under
!lbO<>F
;AII restricted
iproducts
i
i
i
iAii products
i
•
i
i
i
i
i
IPR Notice 83-2
lor as determined
by the Agency
IAN products
i
i
i
i
i
i
i
i
i
i
i
*
i
;AM products
i
PLACEMEN 1 UN LABLL
RtquiRtu
None
lop center
of front
panel
immediately
following
heading of
directions
for use
in tne
directions
for use
in tne
directions
for use
None
PRthtRREU
Same as above
prereraoiy
blocked
immedi ateiy
after misuse
statement
immediately
before
specific
d1 rectl ons
for use or
at the end of
directions
for use
None
__ ______________ ________ __________
COMMENTS
Refer to Appendix 11 guide
PHYS/CHEM
includes a statement or tne xerms or
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 1n a manner
Inconsistent with Its labeling."
Must be set apart and clearly distin-
guishable from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS. and PEST/DIS for further
Information and required statements.
May be 1n metric as wen as u.5. units
-------
104
NAZAAM TO HUMANS
.fttOUIfne
. CAWTtON
IMVMONUtNTAL MAZAMM
MMBALOIICHnMOAi.
HAZAMM
to •
tar » w
PRODUCT
NAME
K
K
A01WIMOMEOCNT:,
MCMT MOMCOKNTV! <
TOTAL:
TMHHOOUOTOONTAM IM Of MNOMXON
KEEP OUT OF REACH OF CHILDREN
CAUTION
fTATCMINT OP nWCTCAL TWATMtNT
PNIYft
•« «M rA1A POM AfiOnVNAL fMOMirCNAMV ITAIIMBira
TOWN.ITATI:
ISTAlUaHMENTNO.:
MTOONn
STORAGE AND
DISPOSAL
WAJWANTYfTAnMDff
-------
105
PRECAUTIONARY STATEMENTS
MAZAROS TO HUMANS
II DOMESTIC ANMALS)
OANOER
ENVIRONMENTAL HAZARDS
PNYSttAlORCMEMCAL
NAZARD1
USE
* •
M4HTHY tTATIMENT
STORAGE AND
* DISPOSAL
RESTRICTED USE
, PESTICIDE ,
treason for clasnifytnp)
P ATO uu caw wr cwnrteo trruwnm on:
. OtWT KffCKVOIOt MO (MLY fCR WQBt
owtwo IT w* ctxnrtn AITUCAJWS
PRODUCT
NAME
ACTIVt tNMCOCNT: ,
Ml HT NWEOCNTS:,
TOTAL:
100.00%
THtf ^MOOUCT CONTAMS IBS Of PM OAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
tTATtMENT Of PRACTICAL TREATMENT
r SWALLOWED:
9 M EYES
SEE SOC PANEL PON AOOmONAL PRECAUTIONARY STATEMENTS
MFO SY SI
TOWN. STATE———.
ISTAiLBHMINTNO.SS
EPAREQISTRATONNO.:
NET CONTENTS:
CROP:
CROP?
CROPs<
CROP:
WARRANTY STATEMENT
-------
§162.8
106
40 CFR Ch. I (7-1-66 Edition)
•) Conditional rt
ition for which
tration. Any
aflreview of sderi-
tifiddata Is needed, ojjher than an
plication which thef? Agency deter-
mine* may be considered for uncoMdi-
tionalY registration upder paragmph
(d) of this section.
application for condit
tinder RIFRA sec. 3(|
reviewed and acted
in i$ 162)160 through!
treated tfs an
l registration
[7) and wAJl be
as sev forth
162.177.
(f) Deri
minlstra
rj vie wed Uhder
section if any of th
paragraph WX2) of
not met. or\if th
data to make\the
> tions.
(1) Not
making a
istration. the \ Adi
notify the appli
of the denial of
set forth the re
for the
tions. if any. whi
in order for the
proved.
(2) Opportunity ft
cant, (i) The app]
days from the
certified letter
corrective actioi
(11) The appli
Administrator
tlon. The A
discretion, de:
drawal and p;
denial in
(fX3) of
(3) FED
the appli
ciency of
the Adnilnistrato:
issue in the FKD;
of denial of
shall set forth the
basis for the denl
the name and
the
centime by weight
dierat in the prod
terus of use, and
of registration.
shall deny an ap
h
req
this
are
uired
e Ad-
(cation
of this
tents of
ion are
sufficient
letermina-
rsectioi
RECK
it fails
Promptly after
[on tb deny a reg-
InWtrator shall
rtified letter
.tlon and shall
id factual basis
and the condi-
mst be satisfied
itration to be ap-
remedy by appli-
it will have 30
receipt of the
the specified
petition the
tw his applica-
tion may, in his
petifyon for with-
a notice of
paragraph
ication. If
remedy the defi-
tlon application.
shall promptly
RBOi8TER\a notice
tlon. Such notice
>ns and Vactual
and shall contain
of the applicant.
ict name. |the name anq per-
1 each active
the proposed)
e proposed elf
cation.
4) Hearing rights. Within 30
fallowing publication of the denial
le FEDERAL REGISTER, the applicant <
interested painty with the writtef
tuthorlzatlon of the
lest a hearing
>) of the Act
chfcpter. If no h
quested, the denial
tive kt the end of th
6n the
that:
(1) Ha& been ob
come to his attenl
(2) Insofar as
previously been
Agency,
become
eAg
tlon.
secttofc 10 o,
after the
e dat*. call
it
ientliic
part of
for that
cept as
the Act.
itration of
for In the
ether with
brmatlon as
relevant -to
e available
bj applicant.
>r registration, re-
Lent of a regis-
3(c)(5) shall
iiiired by the
ic whether his ap-
[pprovied under this
shall \ubmit with
factual informa-
rerse effects of the
Lvironment or man
ed by
Ion; and
is aware.
submitted
or has
not
.the
Informatk
not be
jublished laboj
(dent expei
U8 FR 34C
shall include. Vbut
to. publishedxor
itory studies and
0 162.10 Labeling requirenienta.
(a) General—<1) Contents of the
label Every pesticide products shall
bear a label containing the'informa-
tion specified by the Act and the regu-
lations in this Part. The contents of_a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
122
-------
Environmental Protection Agency
107
162.10
scribed in paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
tiii) The net contents as prescribed
in paragraph (d) of this section:
(iv) The product registration
number as prescribed in paragraph (e)
of this section:
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se*:"
curdy attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank can and other bulk con-
tainers—
-------
§ 162.10
108
purposes other than as a pesticide or
device;
-------
C/ivironmentol Protection Agency
109
§ 162.10
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
* uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—<1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert Ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement.
-------
§ 162.10
110
40 CFR Ch. I (7-1-S6 Edition)
the label: "Not .i>? -aaie or use after
(date]."
(ID The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed In the
ingredient statement if he determines
that such ingredients) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxlcologlcal
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type. size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard MtoHon
Toxic
•tegorta
\
rv
in
nhata
iLC.
Up to and indudng SO
me/kg.
Up to and Indudng .2
rag/Mar.
Up to and IndudJng 200
From SO ttwu 500 mo/kg
From .2 tvu 2 mg/tlar_
From
From £00 tvu 9000 mg/
From 2. tvu 20 mg/Mer_
From 2JOOO tvu 20,000_
Greater tien
hen 20
Greater ttan 20JOOO.
Skini
Corroarve: oomeal
opecMy not reversMe
^^M^Mft T f^m^
wmn / oeys.
Corroe)ye___—_
Comeal opacity
reversible wttrin 7
w T 4<«MM
f f ovy*.
Severe (RtMlon at 72
tain.
hours.
72 hours.
(1) Human hazard signal word—
-------
Environmental Protection Agency HI
162.10
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may. however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categoric*. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXillXA) of
,this section. "The* applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
S« « of label from pane) «t square
MCfteS
5 and under
Above s to »0 _ _
Above 10 to 15
Above IS to 30
(Varan
Pa
Requred
vgnal
word, •«
capitals
^
10
12
14
11
nts
"Keep Out
Of reactl Of
Chrfdren"
fj
6
10
12
(2) Other required warnings and pre-
cautionary statements The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be- modified or ex-
panded to reflect specific hazards.
Tobdty
category
nary statements by tOAicily category
Oral, inhalation, or derma) taxfctty
Skin and eye local effects
II
Ml.
IV
tn n I • n r»rM^t iff ^K^^KjLite&^uf •*»—A.—•— .^ ^^ — *. _ — .^L. — ^
(pOVOnOUB) • 9IWOVPM iWltWOO Qf •MOrDM
tfvough aUn}. Do not bmtto vapor (dust or spray
fflittj. Do ooft QOt *i ojfOit on 0Un« or on cfoftinQ
(Monl ponof stdwnonl of practical trMtrnonl f^-
quired.).
be latH M awtfowed Cinhalad or absorbed
through the akin]. Oo not braatfta vapor* {duct or
apray mist]. Oo not gat In eyea. on akin, or on
clothing. lAppropricle lint aid •UlemenU required.).
Hamtfuf if vwaffov^d dnhafetf or abaorbed tfvough the
afcinl Avoid bmetNng vapor* {duet or aprav miatl.
AvowJ contact «Mh akin leyea or dotrengl. f Appro-
priate first aid statement requfeed.].
fNo preceutenary statements required.)
Conceive, cauaei eye and akin damage [or skin
irritation). Oo not eat in eyea. on akin, or on
clothing. Wear goggle* or face shield and robber
gloves when handbig. Harmful o{ fate) 1 swsJtowed.
{Appropriate first aid statement required.)
Causes eye (and skin) irritation. Oo not get in eyas,
on skin, or on clothing. Harmful V t» slowed. {Ap-
propriate first aid statement oequired.)
Avoid contact with skin, eyes or clothing. In case of
contact immediately flush eyea or skin with plenty of
water. Get medical attention tf MUton persists.
[No precautionary statements required.) -~
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
127
-------
§ 162.10
112
40 CFR Ch. I (7-1-86 Edition)
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
•This Pestidfle is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes.
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazard*.
Warning statements on Che flaznmabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flaart point
Raqukad
(A) PRCMUMZED COMTV
Ftaah point at or Mow 20* F; If thara to • flaahback at
any valva opaning.
Raah point above 20* F and not ovar atr F or IT tha
Kama axtansbn to mora than 10 In long at a dbtanea
of 6 in from tna llama.
Al othar pranurizad eontakwra
Exframaly flammabta. Contents under praaaura. Kaap away
in. aparka, and haatad aurfaoaa. Do not punctura or indn
oontanar. Eipoaura to tamparaturaa abova 130* F may c
aparka. and opan Kama. Do not punctura or Incinarata oontainar.
Expoaura to tamparaturaa abova 130* F may cauaa bursting.
Contanti unbar praaaura. Do not uaa or aton naar naat or opan
flama. Do not punctura or kidnarala oontainar. Ei^naura to
tamparafaraa abova 130* F may cauaa buraflnQ.
(B)
COMTAMKM
At or eatow 20* F.
Abova 20* F and not ovar «T F_
Abova SO* F and not ovar ISO* F.
Extramaty flammaWa. Kaap away tram flra. aparka. and haatad
Ftammabla. Kaap away from haat and opan flama.
Do not uaa or atora naar haat or opan flama.
(i) Direction* for Ite-U) General
requirements—(i) Adequacy and clar-
ity of direction*. Directions for use
must be stated in terms which can .be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(li) Placement of directions for u»e.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a referen.ce to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections In the enclosed circular"~and
(C) The Administrator determines
that it Is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
128
-------
Environmental Protection Agency 113
§ 162.10
Lions for use may be omitted from la-
beling of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
(!) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product Involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
^he hands of tlje general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(/) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that
<1) There is information readily
available to the formulators on the
composition, toxicity, methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
(2) The label dearly states that the
product is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.KKJ) immedi-
ately under the heading "Directions
for Use."
(il) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(ill) The site(8) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pestts) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application. In-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in 1162.1(KhXlXJv))
(x) Any limitations or restrictions on
use required to prevent unreasonable'
adverse effects, such as: -
(A) Required Intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
129
-------
§162.11
114
40 CFR Ch. I (7-1-86 Edition)
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
-------
115
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or 1f there 1s a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
1f the flame extension
1s more than 18 Inches
long at a distance of
6 Inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CUNTAlNLKb
II. 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 Incine-
rate 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.
-------
116
STOR-1
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 1s 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 1n
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 1n original container and placement In
locked storage areas.
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PEST/DIS-1
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 Toxlclty Category I on
the basis of oral or dermal toxldty, or Toxlclty Category I or
II on the basis of acute Inhalation toxldty must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rlnsate 1s 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."
3. The 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 1n 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 1s 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 1n trash."
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CONT/DIS-1
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 dlsposalstatements:
Container Type
jNon-aerosoi products
!(bottles, cans, jars
Non-aerosol products
(bags)
Aerosol products
Statement
;uo not reuse container (bottle, can, jar).
)!R1nse thoroughly before discarding 1n trash.
;uo not reuse bag. Discard bag in trasn.
iKepiace cap ana discard containers in
{trash. Do not Incinerate or puncture.
2. All other products
Instructions, based on container
Container Type
oust bear container
Type, listed below:
Statement
dlsposal
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
paper and
plastic bags
compressed gas
cylinders
jTrlple rinse (or equivalent). Then offer
Ifor recycling or reconditioning, or puncture
land dispose of 1n a sanitary landfill, or by
[other procedures approved by state and local
{authorities.
jinpie rinse (or equivalent), men otter
!for recycling or reconditioning, or puncture
Sand dispose of In a sanitary landfill, or
{Incineration, or, 1f allowed by state and
Ilocal authorities, by burning. If burned,
{stay out of smoke.
irnpie rinse (or equivalent), men dispose
|of 1n a sanitary landfill or by other
{approved state and local procedures.
icompieteiy empty liner by snaking and
{tapping sides and bottom to loosen clinging
{particles. Empty residue Into application
{equipment. Then dispose of Uner 1n a
{sanitary landfill or by Incineration 1f
{allowed by state and local authorities.
ilf drum Is contaminated and cannot be
{reusedv, dispose of In the same manner.
{completely empty bag into application
{equipment. Then dispose of empty bag 1n
{a sanitary landfill or by Incineration,
{or, If allowed by State and local
{authorities, by burning. If burned, stay
{out of smoke.
iReturn empty cylinder tor reuse (or
{similar wording).
*7 Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
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IV. BIBLIOGRAPHY APPENDICES
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120
Guide to Use of This Bibliography
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA 1n
arriving at the positions and conclusions stated elsewhere
In the Standard.. Primary sources for studies 1n 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.
UNITS OF ENTRY. The unit of entry 1n 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.
IDENTIFICATION OF ENTRIES. The entries In this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number 1s unique to the citation, and
should be used at any time specific reference Is required.
It 1s not related to the six-digit "Accession Number" which
has been used to Identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further explanation. 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 1s needed.
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.
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121
a. Author. Whenever the Aq^ncy could confidently
Identify one, the Agency iias 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 1n the past, the trailing parentheses
Include (1n addition to any self-explanatory text)
the following 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 1s defaulted to the
submitter, this element Is omitted.
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122
(4) Volume Identification (Accession Numbers).
The final element 1n 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 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
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123
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00032871 Morris, R.A. (1980) Addition to Synopsis of Fenthlon: Baytex)
Residue Chemistry on Alfalfa and Pasture Grass. (Unpublished
study received Jun 16, 1980 under 3125-73; prep- "»d In
cooperation with Chemom'cs Industries, submitted by Mobay
Chemical Co., Kansas City, Mo.; CDL:242690~A)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxlclty of
Pesticides and Other Agricultural Chemicals to Honey Bees:
Laboratory Studies. By University of California, Dept. of
Entomology. ?: UC, Cooperative Extension. (Leaflet 2287;
published study.)
00062094 Chemagro (1976) [Residues of Fenthlon In Swine TissueJ: Report No.
36071. (Compilation; unpublished study Including report no.
48661, received Aug 2, 1977 under 11556-37; submitted by
Bay vet, Shawnee Mission, Kans.; CDL:230979-1)
00062189 Heath, R.G.; Spann, J.W.; Hill, E.F.; et al. (1972) Comparative
Dietary Toxlcltles of Pesticides to Birds. By U.S. Fish and
Wildlife Service, Patuxent Wildlife Research Center. Washing-
ton, D.C.: USFWS. (Special scientific report—wildlife no. 152;
Chemagro report no. 33423; available from: U.S.Government
Printing Office, Washington, D.C.; 1971 0—460-531; published
study; CDL:092011-Y)
00065775 Mobay Chemical Corporation (19/5) Synopsis of Fenthlon: (Baytex):
Residue Chemistry on Alfalfa and Pasture Grass. (Compilation;
unpublished study received Feb 18, 1977 under 3125-73;
CDL:228621-A)
00065776 Olson, T.J. (1968) Determination of Residues of Fenthlon In Rice
Grain by Thermionic Emission Gas Chromatography: Report No.
20417. Method dated Oct 21, 1968. (Unpublished study recelveded
Feb 18, 1977 under 3125-73; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:228621-B)
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121
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00066832 Arthur, B.W. (1958) Metabolism and Stability of Bayer 29493 In
Several Biological Systems: Report G-505; Report No. 5153.
(Unpublished study received Apr 25, 1960 under unknown admin.
no.; prepared by Alabama Polytechnic Institute, Dept. of Zoology
Entomology, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:110563-F)
00071969 Johnson, J.C.. Jr.; Bowman, M.C. (197?) Responses from cows fed diets
containing Fenthlon or Fenltrothlon. Journal of Dairy Science
55(6):777-782. (Also In unpublished submission received Dec 1, 1976
under 476-EX-80; submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:096471-D)
00075108 Nlessen, H.; Tletz, H.; Frehse, H. (1962) On the occurrence of
biologically active metabolites of the active Ingredient S 1752
after application of Lebaycld. Pflanzenschutz-Nachrlchten
15(3):125-147. (Submitter report no. 12571; also In unpublished
submission received Jul 22, 1966 under 7F0531; submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:090641-AA)
OU081115 Loser, E.; Lorke, ? (1969) Bay 29493: Generation Tests on Rats:
Report No. 1400; 25761. (Unpublished study received May 11,
1971 under 11556-1; prepared by Farbenfabriken Bayer AG, West
Germany, submitted by Bay vet, Shawnee Mission, Kans.; CDL:
100920-AA)
00081363 Doull, J.; Root, M.; Cowan, J.; et al. (1963) Chronic Oral
Tox1c1ty of Bayer 29493 to Male and Female Dogs: Submitter
10853. (Unpublished study received Mar 19, 1963 under 3125-
73; prepared by Univ. of Chicago, Depts. of Pharmacology and
Pathology, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:051134-BH)
00093415 Mobay Chemical Corporation (1966) Fenthlon: Analytical, Residue, and
Flavor Information on Backllne Application to Cattle. Includes
method dated Aug 18, 1965. (Compilation; unpublished study,
Including report nos. 16,509, 16,913, 16,951..., received
Jul 22, 1966 under 7F0531; CDL:090637-A; 090636; 090638)
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125
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00093416 Mobay Chemical Corporalton (1966) Fenthlon: Analytical, Residue, and
Flavor Information on Backline Application to Cattle: Supplement
c No. 1. Compilation; unpublished study received Jul 22, 1966 under
7F0531; CDL:090637-B)
00093422 Mobay Chemical Corporation (1966) Analytical, Residue and Flavor
Information on Application of Fenthlon to Cattle. (Compilation;
unpublished study, Including report nos. 17015, 17062, 17362...,
received Jul 22, 1966 under 7F0531; CDL:090638-B)
00093459 Mobay Chemical Corporation (1966) Fenthlon Residues In Milk and
Cattle. Includes method dated Mar 31, 1966. (Compilation;
unpublished study, Including rept. nos. 17445, 17887, 18067...,
received Jul 22, 1966 under 7F0531; CDL:090642-B)
00107081 Darsle, R.; Lake. R.; Kutz, F.; et al. (1962) Studies of Baytex
Toxlclty to Certain Salt Marsh Waterblrds: Submitter 11053J.
(Unpublished study received Sep 2, 1966 under 7F0531; prepared
by Univ. of Delaware, submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:092064-0)
00114318 Puhl, R.; Hurley, J. (1978) The Metabolism and Degradation of
Baytex-r1ng-l-13,14C on Soil: Report No. 66758. (Unpublished
study received Aug 30, 1982 under 3125-73; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:248330-A)
00115216 Bayvet (1973) [Analyses for Residues of Fenthlon In Swlnej.
(Compilation; unpublished study received Sep 14, 1982 under
11556 34; CDL:248407-A)
00115886 Mobay Chemical Corp. (1965) Fenthlon: Metabolic, Analytical
and Residue Information on In feed Application to Cattle.
(Compilation; unpublished study received 1965 under 7F0531;
CDL:092819-A)
00115887 Mobay Chemical Corp. (19/0) LFenthlon Residues In Milk, Eggs,
Poultry Tissues and Alfalfa HayJ. (Compilation; unpublished
study received on unknown date under 9F0811; CDL:093129-A)
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126
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00115889 Mobay Chemical Corp. (1973) Fenthlon: Analytical and Residue
Information on Backllne Application to Swine. (Compilation;
unpublished study received Feb 19, 1974 under 4F1472; CDL:
093919-A)
00115895 Bayvet (1970) Fenthlon: Analytical and Residue Information on
Spotton Application to Cattle. (Compilation; unpublished study
received Mar 14. 1972; Jun 20, 1972 under 11556-37; CDL:102518-A)
00115898 Crawford, C.; Nelson, D. (1970) Safety of Tlguvon Spotton to Cattle
at Five Times the Recommended Rate: Report No. 28085. (Unpub-
lished study received Nov 14, 1974 under 11556-37; prepared by
Chemagro Corp., submitted by Bayvet, Shawnee Mission, KS;
CDL:102520-B)
00115908 Bayvet (1974) [Fenthlon Residue Determination 1n Various ProductsJ.
(Compilation; unpublished study received Sep 3, 1975 under
11556-37; CDL:195118-A)
00115918 Simmons, C. (1975) Leaching Characteristics of Baytex on Aged Soil:
Report No. 45653. (Unpublished study received Sep 13, 1976 under
unknown admin, no.; submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:225820-H)
00115926 Brady, U.; Arthur, B. (1961) Metabolism of 0,0-d1methy1 0-L4-(meth-
ylth1o)-M-tolyl! phosphorothloate by white rats. Journal of
Economic Entomology 54(6):1232-1236. (Submitter 6782; also In
unpublished submission received Sep 13, 1976 under unknown
admin, no.; submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:225821-B)
00115928 Mobay Chemical Corp. (1968) LDetermination of Residues of Fenthlon
(Baytex) In Various Products. (Compilation; unpublished study
received Sep 13, 1976 under unknown admin, no.; CDL:225821-D)
00115932 Thornton, J. (1977) To Determine Possible Tissue Residues Resulting
from Dermal Backllne Application of Lysoff: Report No. 54691.
(Unpublished study received Aug 2, 1977 under 11556-48; submit-
ted by Bayvet, Shawnee Mission, KS; CDL:230980-A)
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127
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
HRID CITATION
00116380 Elder, J.; Henderson, C. (1969) Pesticides Field Appraisal: Field
Appraisal of ULV Baytex Mosquito Control Applications on Fish
and wndiffer Mobay 24528. (U,S. Fish and Wildlife Service,
D1v. of Wildlife Services, D1v. of Fishery Services and Ohio,
Dept. of Natural Resources, D1v. of Wildlife; unpublished study;
CDL:007010-A)
00116381 Mobay Chemical Corp. (1969) Fenthlon: Analytical and Residue
Information on Backllne Application to Cattle. (Compilation;
unpublished study received Jul 9, 1969 under 3125-238; CDL:
007184-A)
00116386 Chemagro (1972) [Fenthlon: Residues 1n Cattle]: Report No. 33149.
(Unpublished study received Jun 6, 1972 under 11556-34; submitted
by Bayvet, Shawnee Mission, KS; CDL:014018-B)
00116396 Schaefer, C.; Dupras, E. (1970) The effects of water quality,
temperature and light on the stability of organophosphorus lar-
vlcldes used for mosquito control. Pages 67-75, In Proceedings
and Papers of the Thirty-Seventh Annual Conference of the Cali-
fornia Mosquito Control Assn., Inc; Jan 27-29, 1969. LS.l.!:
The Assoc. (Also In unpublished submission received Aug 3, 1970
under 1F1019; submitted by Mobay Chemical Corp., Kansas City,
MO; CDL:091069-C)
00116398 Mobay Chemical Corp. (1968) Fenthlon: Analytical and Residue In-
formation: Dairy Barn and Poultry House Spray. (Compilation;
unpublished study received Jun 5, 1969 under 9F0811; CDL:
091401-A)
00116399 Chemagro Corp. (1969) Recovery of Fenthlon from Alfalfa and Pasture
Grass: Report No. 24609. (Unpublished study received on unknown
date under 9F0774; CDL:098672-A)
00116748 Mobay Chemical Corp. (1967) [Study: Fenthlon Residue 1n Selected
ProductsJ. (Compilation; unpublished study received Jul 22,
1966 under 7F0531; CDL.-095237-1)
00116749 Chemagro Corp. (1967) [Study: Fenthlon Residue In Selected
ProductsJ. (Compilation; unpublished study received on unknown
date under 9F0811; CDL:098470-A)
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128
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00116750 Chemagro Corp. (1968) (.Study: Fenthion Residue In RlceJ. (Compil-
ation; unpublished study received on unknown date under 9F0774;
CDL:098659-A)
00116751 Chemagro Corp. (1968) Supplement No. 2 to Brochure Entitled:
Fenthion—Metabolic, Analytical, and Residue Information on
Spray and Granular Application to Alfalfa and Rangeland Grasses.
Compilation; unpublished study received on unknown date under
9F0774; CDL:098670-A)
00132309 Mobay Chemical Corp. (1982) Baytex: Residue Chemistry on Fruits
(Grapefruit, Oranges and Mangoes): Brochure No. 1128; Document
No. AS 83-2312. (Compilation; unpublished study received Oct
14, 1983 under 4E2983; CDL:072021-A)
00132312 DuBols, K.; K1noshHa, F. (1970) The Acute Oral and Dermal Toxlclty
of Two Samples of Bay 29493: LRats, Rabbitsj: LSubmltterJ 28579.
(Unpublished study received Oct 14, 1983 under 4E2983; prepared
by Univ. of Chicago, Toxlclty Laboratory, submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:072022-C)
00132314 Mihall, F.; Lorke, D. (1978) S 1752 (Lebaydd Active Ingredient):
Determination of Percutaneous Toxlclty: Report No. 7604; 66257.
(Unpublished study received Oct 14, 1983 under 4E2983; prepared
by Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:072022-E)
OU132317 Thyssen, J.; Lorke, D. (1978) S 1752 (Active Ingredient of Lebay-
dd): Acute Inhalation Toxlclty: LRatsJ: Report No. 7842; 66646.
(Translation; unpublished study received Oct 14, 1983 under
4E2983; prepared by Bayer AG, W. Ger., submitted by Mobay Chemi-
cal Corp., Kansas City. MO; CDL:072022-I)
00132319 Thy s sen, J.; Lorke, D. (1982) S 1752 (Fenthion, Lebaydd Active In-
gredient): Test for Irritant Effect on Skin or Mucous Membrane:
[RabbitsJ: LSubmltterJ 82764. (Unpublished study received Oct
14, 1983 under 4E2983; prepared by Bayer AG, W. Ger., submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:072022-K)
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129
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00132341 Hoffmann. K.; Helscher. C.; Lorke, D. (1975) Fenthlon: Chronic
Toxlclty Study on Dogs (Two-year Feeding Experiment): Report No.
5737; 49503. (Unpublished study received Oct 14, 1983 under
4E2983; prepared by Bayer AG. W. Ger., submitted by Mobay
Chemical Corp.. Kansas City. MO; CDL:072022-AH)
0132344 Loser. £.; Lorke, D. (1969) Bay 29493: Generation Tests to Rats:
Report No. 1400; 25761. (Unpublished study received Oct 14.
1983 under 4E2983; prepared by Farbenfabrlken Bayer AG, W. Ger.,
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
072022-AK)
00132346 Macherner, L.; Lorke. D. (1978) S 1752 (Fenthlon. Lebaydd Active
Ingredient): Evaluation for Embryotoxic and Teratogenlc Effects
in Orally Dosed Rats: Report No. 7580; 66258. (Unpublished
study received Oct 14, 1983 under 4E2983; prepared by Bayer AG,
W. Ger., submitted by Mobay Chemical Corp., Kansas City. MO;
CDL:072022-AM)
00132347 Becker. H.; Mueller, E.; Llnd. H.; et al. (1982) Embryotoxidty and
Teratogenlcity Study on S 1752 In Rabbits: RCC Project 004961;
84007. Final rept. (Unpublished study received Oct 14, 1983
under 4E2983; prepared by Research & Consulting Co. Ltd.,
Switz., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:072022-AN)
00132348 Herbold, B.; Lorke, D. (1980) S 1752: Fenthlon—Lebaydd Active In-
gredient: Salmonella/Microsome Test for Detection of Polnt-muta-
genlc Effects: Report No. 9088; 80434. (Unpublished study re-
ceived Oct 14, 1983 under 4E2983; prepared by Bayer AG. W. Ger..
submitted by Mobay Chemical Corp.. Kansas City, MO; CDL:
072022-AO)
00132349 Inukal, H.; lyatomi, A. (19/6) Fenthlon: Mutagenlclty Test on Bac-
terial Systems: Report No. 30; 82760. (Unpublished study re-
ceived Oct 14. 1983 under 4E2983; prepared by NITOKUNO. Japan.
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
072022-AQ)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MR ID CITATION
00132350 SMrasu. Y.; Morlya, M.; Kane da, Y. (1979) Report of the Mutageni-
clty Study of FentMon: (.Submitter! 82763. (Unpublished study
received Oct 14, 1983 under 4E2983; prepared by Institute of En-
vironmental Toxicology, submitted by Mobay Chemical Corp., Kan-
sas City, MO; CDL:072022-AS)
00132351 Oesch, F. (1977) Ames Test for Lebaycld (Fenthlon): 82762. (Unpub-
lished study received Oct 14, 1983 under 4E2983; submitted by
Mobay Chemical Corp., Kansas City, MO; CDL:072022-AT)
000132352 Machemer, L.; Lorke, D. (1978) S 1752 (Fenthlon; Lebaycld Active
Ingredient): Dominant Lethal Study on Male Mice To Test for Mu-
tagenlc Effects: Report No. 7449; 66144. (Unpublished study re-
ceived Oct 14, 1983 under 4E2983; prepared by Bayer AG, W. Ger.,
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
072022-AU)
00132353 Herbold, B.; Lorke, D. (1980) S 1752: Fenthlon—Lebaycid Active In-
gredient: Mlcronucleus Test on Mouse To Evaluate S 1752 for Mu-
tagenie Potential: Report No. 9577; 80318. (Unpublished study
received Oct 14, 1983 under 4E2983; prepared by Bayer AG, W.
Ger., submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
072022-AV)
00132356 Rosenblum, I. (1980) A Safety Evaluation of Fenthlon (S1752) in
Rhesus Monkeys ...: LSubmitter! 68789. Final rept. (Unpub-
lished study received Oct 14, 1983 under 4E2983; prepared by
Albany Medical College, Institute of Comparative and Human Toxi-
cology, submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
072022-AY)
00147245 Rosenblum, I. (1980) A Safety Evaluation of Fenthlon (S1752) in
Rhesus Monkeys (Macaca mulata): Final Report: Report No. 68789.
Unpublished study prepared by The Albany Medical College of Union
University. 117 p.
00147316 Herbold, B. (1983) E.1752 Pol Test on E. coll to Evaluate for Po-
tential DNA Damage: Report No. 11919. Unpublished study pre-
pared by Bayer AG. 12 P.
00154963 US Environmental Protection Agency (19/6) Determining and Monitoring
the Toxlcity of Baytex to P1nk Shrimp at Sanlbel Island, Florida:
Report No. 65762. Unpublished report. 43 p.
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131
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
00154967 Mobay Chemical Corp. (1984) Residue and Metabolism Data: Baytex.
Unpublished compilation. 553 p.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxidty of
pesticides to wildlife: Second edition. US Fish and Wildlife
Service: Resource Publication 153. 91 p.
05000819 Korn, S.; Earnest, R. U974) Acute toxidty of twenty Insecticides to
striped bass Morone saxatills. California Fish and Game
60(3):128-131.
05000975 Tucker, R.K.; Haegele, M.A. (1971) Comparative acute oral toxlclty
of pesticides to six species of birds. Toxicology and Applied
Pharmacology 20(l):57-65.
05014941 Pickering, Q.H.; Henderson, C. (1966) The acute toxlclly of some
pesticides to fish. Ohio Journal of Science 66(5):508-513.
40085801 Talbott, T. (1987) Product Chemistry of Baytex Technical for Use
Only 1n the Manufacture of Economic Poisons: Baytex Liquid Con-
centrate Insecticide. Unpublished study prepared by Mobay Corp.
30 p.
40085802 Talbott, T. (1987) Product Chemistry of Baytex Technical for Use
Only 1n the Manufacture of "Economic Poisons: Baytex Liquid Con
centrate Insecticide. Unpublished compilation prepared by Mobay
Corp. 87 p.
40094602 Johnson, W.; Flnley, M. (1980) Handbook of Acute Toxlclty of
Chemicals to Fish and Aquatic Invertebrates: Resource Publication
137. US Fish and W1ld7Jfe Service, Washington, D.C. 106 p.
40110401 Christopher, R.; Lane, J. (19871 Aqueous Photolysis of Baytex In
Sterile Buffered Solution: Project ID: BX-01-86. Unpublished
study prepared by Mobay Corp. 27 p.
40110402 Ciarletta, J. (1986) Pytotoxlclty (sic) Responses from Fenthlon/
Diesel 011 Mixtures Applied as Foliar and Seed Treatments to
Ten Plant Species: Report No.: 94272. Unpublished compilation
prepared by Mobay Corp. 14 p.
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132
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
HRID CITATION
40186701 Stubblefleld, W. (1987) Baytex (technical grade)—Acute LD50 to
BobwMte Quail: Report No. 94418: Study No. 86-015-06. Unpub-
lished study prepared by Mobay Corp. 27 p.
40186702 Stubblefleld, W. (1987) Baytex Technical: Subacute Dietary LC50 to
Bobwhlte Quail: Report No. 94420: Study No. 86-175-09. Unpub-
lished study prepared by Mobay Corp. 29 p.
40186703 Stubblefleld. W. (1987) Baytex Technical: Subacute Dietary LC50 to
Mallard Ducks: Report No. 94424: Study No. 86-175-08. Unpub-
lished study prepared by Mobay Corp. 30 p.
40186704 Elgenberg, D. (1987) Acute Oral Toxldty of Baytex Technical 1n
Albino Rats: Report No. 94466: Study No. 87-011-01. Unpublished
study prepared by Mobay Corp. 21 p.
40186705 Elgenberg, D. (1987) Acute Dermal Toxlclty of Baytex Technical 1n
Albino Rabbits: Report No. 94467: Study No. 87-023-01. Unpub-
lished study prepared by Mobay Corp. 19 p.
40186706 Shlotsuka, R. (1987) Acute Inhalation Toxldty Study with Baytex
Technical In Rats: Report No. 94313: Study No. 86-041-26.
Unpublished study prepared by Mobay Corp. 33 p.
40186/07 Moore, K. (1987) A Liquid Chromatographlc Method for the Determi-
nation of FentMon (Baytex) 1n Inhalation Chamber Atmospheres:
Report No. 94312. Unpublished study prepared by Mobay Corp.
15 p.
40186708 Elgenberg, D. (1987) Primary Eye Irritation of Baytex Technical 1n
Albino Rabbits: Report No. 94307: Study No. 86-333-07. Unpub-
lished study prepared by Mobay Corp. 16 p.
40186709 Elgenberg, D. (1987) Primary Dermal Irritation of Baytex Technical
In Albino Rabbits: Report No. 94308: Study No. 87-323-01. Un-
published study prepared by Mobay Corp. 16 p.
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133
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
40186710 Flucke, W. (1987) Study of Skin Sensltlzatlon Effect on Guinea
Pigs: (Maximization Test of Magmas on and KHgman): Report No.
94394: Bayer Report No. 15428. Unpublished study prepared by
Bayer AG. 41 p.
40186711 Forbls, A. (1986) Acute Toxlclty of Baytex to Selenastrum caprl-
cornutum Prlntz: Final Report #35314. Unpublished Mobay report
No. 94419 prepared by Analytical Bio-Chemistry Laboratories,
Inc. 165 p.
40186712 Hughes, J. (1987) The Toxlclty of Baytex Technical, Lot No. ... to
Anabaena flos-aquae: Laboratory Project ID: 1059-01-1100-4.
Unpublished Mobay report No. 94428 prepared by Malcolm Plrnle,
Inc. 40 p.
40186713 Hughes, J. (1986) The Toxlclty of Baytex Technical, Lot No to
Skeletonerca costatum: Laboratory Project ID: 1059-01-1100-2.
Unpublished Mobay report No. 94429 prepared by Malcolm Plrnle,
Inc. 40 p.
40186714 Hughes, J. (1987) The Toxlclty of Baytex Technical, Lot No to
Lemma gibba: Laboratory Project ID: 1059-01-1100-3. Unpublished
Mobay report No. 94430 prepared by Malcolm P1rn1e, Inc. 38 p.
40186715 Hughes, J. (1986) The Toxlclty of Baytex Technical, Lot No.... to
Navlcula pelllculosa: Laboratory Project ID: 1059-01-1100-1.
Unpublished Mobay report No. 94461 prepared by Malcolm Plrnle,
Inc. 40 p.
40194201 Christopher, R.; Lane, J. (1987) Leaching Characteristics of Aged
Soil Residues of Baytex: Project No.: BX-02-87. Unpublished
study prepared by Mobay Corp. 40 p.
40214201 Swlgert, J. (1986) Acute Flow-through Toxlclty of Baytex to Rainbow
Trout (Salmo galrdnerl): Final Report #35313. Unpublished Mobay
report 94470 prepared by Analytical Bio-Chemistry Laboratories,
Inc. 149 p.
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134
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
MRID CITATION
40223001 Talbott. T. (1987) Product Chemistry of Baytex Technical for Use
Only 1n the Manufacture of Economic Poisons: Baytex Liquid Con-
centrate Insecticide: BR 1543. Unpublished compilation prepared
by Mobay Corp. 96 p.
40223002 Talbott. T. (1987) Product Chemistry of Baytex Technical for Use
Only 1n the Manufacture of Economic Poisons: Baytex Liquid Con-
centrate Insecticide: Supplement 1: BR 1542. Unpublished study
prepared by Mobay Corp. 12 p.
40228401 Mayer, F. (1986) Acute toxlclty handbook of chemicals to estuarlne
organisms: EPA/600/X-86/231. Prepared by US EPA Environmental
Research Laboratory, Gulf Breeze, FL. 275 p.
40229201 Flucke, W.; Kallner, G. (1987) E 1752: (Common Name: Fenthlon, the
Active Ingredient of Baytex): Acute Neurotoxldty Studies on
Hens following Oral and Dermal Administration: Bayer Report No.:
15088; Mobay ACD No.: 91341. Unpublished study prepared by
Bayer AG. 86 p.
40246401 Forbls, A. (1987) Acute Flow-through Toxlclty of Baytex to Daphnia
magna: ABC Final Report #35598. Unpublished Mobay Report 94576
prepared by Analytical B1o-Chem1stry Laboratories, Inc. 179 p.
40247101 DeWeese, L.; McEwen, I.; Debllnger, R.; et al. (1981) Mosquito
control with chemicals and the Impacts on wildlife. P. 23-25
In West Central Mosquito and Vector Control Association Pro-
ceedings; February 4 & 5, 1981, Boulder, CO.
40247102 Powell, G.; DeWeese, L.; Lamont, T. (1981) A field evaluation of
frogs as a potential source of secondary organophosphorus In-
secticide poisoning. Can. J. Zool. 60:2233-2235.
40247103 Clark, J.; Duke. T. (1983) Effects of Mosquito Control Applications
of the Pesticide Fenthlon on Nontarget Estuarlne Organizations:
Preliminary Report: No. SR-105. US EPA Environmental Research
Lab, Gulf Breeze, FL. 87 p.
40247104 Powell, G. (1984) Reproduction by an altrlclal songbird, the red-
winged blackbird, 1n fields treated with the organophosphate
Insecticide fenthlon. J. Applied Ecology 21:83-95.
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135
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevlnphos Standard
HRID CITATION
40247105 Borthwlck, P.; Clark. J.; Montgomery, R. (1985) Field confirmation
of a laboratory-derived hazard assessment of the acute toxldty
of fenthlon to pink shrimp (Penaeus duorarum): Special Technical
Publication. Aquatic Toxicology and Hazard Assessment: ASTM
891. P. 177-189.
40274101 Swigert, J. (1987) Acute Flow-through Toxlclty of Baytex to Blue-
gill Sunflsh (Leponls macrochlrus): Final Report #35597. Un-
published Mobay report 94632 prepared by Analytical Bio-Chemis-
try Laboratories, Inc. 175 p.
40329401 Kowalskl, R.; Clemens, G.; Bare, J.; et al. (1987) A Teratology
Study with Fenthlon (Baytex Technical) 1n the Rat: Report No.
MDT0029: Toxicology Report No. 935. Unpublished Mobay Report
No. 94815 prepared by Miles Laboratories. 192 p.
40329501 Bailey, D. (1987) 21-Day Dermal Toxiclty Study In Rabbits with
Baytex Technical: HLA Study No. 339-118. Unpublished Mobay re-
port no. 94822 prepared by Hazleton Laboratories America, Inc.
157 p.
40462701 Clemens, G.; Bare, J.; Hartnagel, R. (1987) A Teratology Study 1n
the Rabbit with Fenthlon (Baytex Technical): Rept. No. MTD0039.
Unpublished study prepared by Miles Inc. 143 p.
40495501 Surprenant, D. (1988) Acute Toxiclty of Technical Grade Fenthlon
(Trade Name Baytex) to Sheepshead Minnow (Cyprlnodon varlegatus)
under Flow-through Conditions: Report #87-9-2506: Study #274.
0587.6152.505. Unpublished study prepared by Sprlngborn Life
Sciences, Inc. 31 p.
40564101 Surprenant, D. (1988) Acute Toxiclty of Technical Grade Fenthlon
(...) to Eastern Oysters (Crassostera vlrglnlca) Under Flow-
through Conditions: Study No. 274-0587-6153-504. Unpublished
study prepared by Sprlngborn Life Sciences, Inc. 35 p.
40564102 Surprenant, D. (1988) The Toxiclty of Technical Grade Fenthion
(...) to Rainbow Trout (Salmo gairdnerl) Embryo and Larvae: Stu-
dy No. 274.0587.6154.121. Unpublished study prepared by Spring-
born Life Sciences, Inc. 51 p.
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136
V. FORMS APPENDICES
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137
Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
EPA REGISTRATION NO.
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme. I enclose the protocols that I will use:
O2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
Q 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product. (Tim option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
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138
Form Appro»d. OMB No. 20700057. Exptiw 11-3M8.
f7b qu§lffy. certify ALL four items)
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 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 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
herns 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) if final agreement on all terms could not be reached otherwise. This offer was made
tntthe following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4,'Wy 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 8S80-6 (10-821
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139
OMB Approval No.
2070-0057
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
"Registration
Guideline No.
sec. 158. izo
PRODUCT
CHEMISTRY
61-1
61-2
61-3
6Z-1
62-2
62-3
63-2
63-3
63-4
63- b
63-6
63-7
63-8
63-9
63-1U
63-11
Name of Test
identity of
Ingredients
statement of
composition
Discussion or
formation of
Ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
color
Physical state
Odor
Melting point
Boiling point
Density. DUIK-
denslty. or
specific gravity
solubility
Vapor pressure
Dissociation
constant
uctanoi /water
partition
coefficient !
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
citing MKIU
Number or
EPA Accession
Number
i submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
63-12
EPA Form 8580-4
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140
OMB Approval No.
2070-0057
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT (confd)
Date
Guidance Document for
Registration
Guideline No.
sec. 158. izu
PRODUCT
CHEMISTRY
(confd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63- ZO
63-21
Sec. 158. 13b
TOXICOLOGY
81-1
81-Z
81-3
81-4
81-5
81-6
81-/
Name of Test
stabi i i ty
oxidizing/reducing
reaction
Fl ammabi 1 1 ty
Expiodabi nty
storage stabi nty
viscosity
Ml SCI D1 1 1 ty
corrosi on
characteristics
Dielectric break-
down voltage
Acute oral
toxlclty, rat
Acute dermal
toxlclty, rabbit
Acute inhalation,
toxlclty, rat
Primary eye
Irritation, rabbit
primary dermal
Irritation
Dermal sensltlza-
tlon,
Acute Delayed
neurotoxlclty, hen
lest noti
required
for my
product
listed
above
(check
below)
•
I am complying with
data requirements by
citing MRID i
Number or
EPA Accession
Number
submit-
ting
Data
(At-
tached)
I
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4 (confd)
-------
•Al
OMB Approval No. 2070-0057
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 requlrenent 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 FIFRA
Section 3, and which 1s purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (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 1n 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 Form 8570-4. The registered
source(s) of the above named active Ingredient In my product(s) Is/are
and their registration number(s) Is/are .
fly firm will apply for an amendment to the registration prior to changing the source
of the active Ingredient 1n our product.
(4) I understand, and agree on behalf of my firm, that If at any time any portion of
this Statement 1s no longer true, or If my firm falls to comply with the undertakings made
1n this Statement, my firm's product's registration may be suspended under FIFRA Section
3{c)(2)(B).
(5) I further understand that 1f 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 reglstrant(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 1n 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
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