&EPA
United States
Environmental Protection
Agency
Off ice of
Pesticides and Toxic Substanc
Washington OC 20460
Pesticides
July 1987
Guidance for the
Reregistration of
Pesticide Products
Containing FENITROTHION
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
FENITROTHION
AS THE ACTIVE INGREDIENT
CAS NO. 122-14-5
EPA CASE NUMBER 445
EPA Pesticide Chemical Code (Shaughnessy)
Number 105901
JULY, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
C. Regulatory History
III. Agency Assessment 8
A. Summary
B. Preliminary Health Risk Assessment
C. Environmental Profile
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 23
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 33
VI. Requirement for Submission of Generic Data 35
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existirjg stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 41
VIII,. Requirement for Submission of Revised Labeling 42
IX. Instructions for Submission 42
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA'Form 8570-27 Generic Data Exemption Statement
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I. INTRODUCTION
' EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^-, 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.
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they . ..
become aware of such information. Registrants should notify
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the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
'effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: Fenitrothion
Chemical Name: 0,0-dimethyl 0-(4-nitro-m-tolyl)
phosphorothioate
Other Chemical
Nomenclature: 0,0-dimethyl 0-(3-methyl-4-nitrophenyl)
phosphorothioate; 0,0-dimethyl 0-(4-nitro-m-
tolyl) phosphorothioate
Trade Names;
Bayer 41831; Bayer S-5660; Bayer S-1102A;
AC-47,300; C 47114; Accothion; Cytel;
Cyfen; Folithion; Sumithion; Agrothion;
Dicofen: Fenstan; Metathion E-50; Verthion;
Cekutrothion; Dybar; Fenitox; Novathion;
and Nuvanol.
CAS Registry Number: 122-14-5
EPA Pesticide Chemical Code (Shaughnessy) Number: 105901
Empirical Formula: CgH^NOsPS
Molecular Weight: 277.2
Chemical/Physical
Characteristics of a
95% technical grade: Color: yellow-brownish
Physical state: oily liquid
Odor: data gap
Specific gravity: 1.32 -1.34
Boiling point: 118 °C at 0.01 mm Hg
Melting point: 0.3 °C
Solubility: data gap
pH: data gap
Vapor pressure: data gap
Stability: data gap
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B. _J1SE-ESOEILE—
Fenitrothion is a nonsysteraic organophosphate insecticide
and acacicide federally registered for use on ornamentals; in
forests; and in and around domestic, commercial, institutional
and—industrial ar.e.as (including transportation vehicles). End-
use formulations consist of a 40% wettable powder; 4 and 8
pound per gallon emulsifiable concentrates (45.5- and 76.8%
active ingredient, respectively); and a 93% soluble concen-
trate/liquid.
There are two forestry uses registered for fenitrothion.
In one, fenitrothion, formulated as an emulsifiable concentrate,
is applied as a foliar spray to control spuce budworm on spruce
and fir tree forests using aerial equipment. The use is limited
geographically to the northeastern United States, and application
may only be made under the supervision of qualified state or
federal officials responsible for insect control programs on
forest areas. The second use is for control of southern pine
beetles in pine forests using an emulsifiable concentrate
formulation. Application is made either by spray application
to the bark of trees using hand or power operated ground applica-
tion equipment; or by a special "hack and squirt" application
technique whereby a squirt bottle is used to deliver the
insecticide into hack cuts in the tree.
Fenitrothion, formulated as 4 and 8 pound per gallon
emulsifiable concentrates, is registered for the control of
various household insect pests in and around non-food domestic,
commercial, institutional, and industrial areas (including
transportation vehicles). Application is made by coarse low
pressure spot spray and/or paint brush to infested areas.
One product, consisting of a 40% wettable powder, is registered
for residual control of adult Anopheline mosquitoes in human
dwellings. Application may only be made under the supervision
of state or federal officials responsible for malaria control.
Fenitrothion is not used in this country for mosquito control;
however, the World Health Organization (WHO) recommends its
use as a vector control agent for malaria in other countries.
The ornamental use pattern of fenitrothion includes
outdoor, greenhouse, and nursery uses. For these uses, feni-
trothion, formulated as an emulsifiable concentrate, is applied
to the plant as a foliar broadcast or spot spray using ground
application equipment.
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j
Technical fenitrothion is manufactured in Japan by the
Sumitomo Chemical Company, and is imported into the United
States by Sumitomo Chemical America, Inc. The exclusive U.S.
distribution rights are currently held by FBI/Gordon Corporation
of Kansas City, Missouri. Available usage information for the
year 1985 indicates that fenitrothion is used solely on orn-
amentals, and that the total volume used is relatively small.
Usage data further indicate that its use occurs primarily in
the North Central and North Eastern portion of the country.
Fenitrothion is probably used for control of southern pine
beetles in pine forests under the recently approved 24-c "special
local need" registrations utilizing the "hack and squirt"
method of application, although usage data are not available
for confirmation.
The Agency has currently issued 15 registrations to 4
registrants for fenitrothion-containing products. Of this
total, two products are formulation intermediates (25.02% and
80%), and one is a technical product (95%). All products are
singleactive ingredient formulations£/ with the exception of
one product, a formulation intermediate, which contains fenitro-
thion in combination with d-cis/trans alletrin and MGK 264.
For a complete listing of the formulations refer to the EPA
Index to Pesticide Chemicals 0,0-dimethyl 0-(4nitro-tolyl)
phosphorothioate dated October 31, 1986 (Appendix III). There
are 3 "special local need" registrations issued under FIFRA
section 24(c) (EPA SLN No.'s MS-860007, LA-860008 and VA-870003).
There are no intrastate products containing fenitrothion.
C. REGULATORY HISTORY
The first United States registration for the pesticide
fenitrothion was issued by the EPA on March 20, 1975 under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The registration was for control of spruce budworm in forests
under the supervision of federal or state officials responsible
for insect control programs in forest areas.
Historically, fenitrothion has been used for control of
spruce budworm in forests in the northeastern United States,
and for household and commercial pest control. These markets
have been lost, however, due to problems with bird kills
resulting from the forestry use, efficacy, and staining
problems resulting from the household and commercial use.
The Agency considers all currently registered products containing
fenitrothion in combination with solvents or diluents to be sole
active ingredient formulations. The Agency does not consider
solvents or diluents to be insecticidal and therefore, must be
declared as inerts.
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One Data Call-in has been issued on fenitrothion. The
Agency, in 1984, as pact of a program to assure the complete-
ness of the chronic toxicology data base of a chemical prior to
development of its Registration Standard, required registrants
of fenitrothion-containing products to submit a teratology study
in a species other than the rat and a chronic feeding study in
a non-rodent__sp_e_aies^ -These—s-t«44es -have been received by the
Ageno-v-^—Based on its review, the requirement for a chronic
feeding study (non-rodents) has been satisfied; the rabbit
teratology study is unacceptable and constitues a new study is
required.
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III. AGENCY ASSESSMENT
A. SUMMAR-Y-
The Agency has reviewed all data currently supporting the
registration of fenitrothion. Based on the available data, EPA
has reached the fol-lowing con c IJJLSJLOns. .The points summarized
below are presented in further detail, in the context of EPA's
science findings and additional data requirements, in Sections
B through D.
1. The Agency is concerned over the potential adverse
impact of fenitrothion on birds and aquatic organisms resulting
from the forestry use pattern. The Agency is requiring
comprehensive aquatic and terrestrial field studies to quantify
effects on aquatic and avian species to determine if the hazard
indicated by the available field evidence is ecologically
significant. The Agency is also requiring restricted-use
classification of the forestry uses on an interim basis, pending
receipt and evaluation of the required studies. Upon receipt
and evaluation of these studies, the Agency will determine
whether labeling modification or other regulatory action is
warranted.
2. Recent studies, as well as historical data, have
implicated fenitrothion along with other organophosphate pest-
icides in causing human eye effects, such as retinal degeneration
and myopia. For these reasons, the Agency is requiring special
acute and sub-chronic rat studies to determine fenitrothion's
effect on the eye. Upon receipt and evaluation of these
studies, the Agency will determine whether labeling modification
or other regulatory action is warranted.
3. Technical fenitrothion is a moderately acutely toxic
cholinesterase-inhibiting pesticide, which is placed in Toxicity
Category II for the oral and dermal route of exposure and
Toxicity Category III for the inhalation route of exposure.
Technical fenitrothion is mildly irritating to the eyes and
skin (Toxicity Category III). Results of a dermal sensitization
study using technical fenitrothion were negative. Fenitrothion
does not demonstrate acute delayed neurotoxic effects.
4. Because there are substantial chronic toxicology and
residue chemistry data gaps for fenitrothion, the Agency will
not grant any new food use registrations or new tolerances • f.or
fenitrothion until these gaps are filled.
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5. Laboratory! data show that technical fenitrothion is
potentially highly jto very highly toxic to birds, honeybees,
and aquatic invertebrates. Labeling statements are required by
this Standard. Precautions to protect potentially exposed
endangered species are required by this Standard and separately
through a Pesticide Registration (PR) Notice.
6. The Agency is unable to assess the potential for
fenitrothion to contaminate groundwater. Based on preliminary
information, fenitrothion degrades fairly rapidly in soil and
water, and therefore, may not pose groundwater concerns.
However, the environmental fate of fenitrothion is largely
uncharacterized, and additional data are needed in order for
the Agency to fully assess its fate in the environment and
potential for contaminating groundwater.
7. Residue data are not available to determine what
levels, if any, of fenitrothion are present in treated homes
as a result of application of the 40% wettable powder formu-
lation to control adult Anopheline mosquitoes. The Agency
is requiring indoor air residue monitoring data to support this
use.
8. The Agency is requiring submission of applicator
exposure data from dermal and respiratory routes of exposure
to determine whether exposure to applicators during application
may be posing health risks.
9. .An interim 24 hour reentry interval is imposed for
the greenhouse and nursery ornamental uses of fenitrothion,
until such time as the appropriate reentry data have been
submitted and evaluated.
As a result of this Registration Standard review, the
Agency has determined that certain additional or revised label
restrictions are necessary. The Agency has also identified
missing data necessary to fully evaluate the human and environ-
mental risks associated with the use of fenitrothion as an
insecticide/acaricide. These data must be developed in order
to maintain registrations of existing products or register any
new products containing fenitrothion. A summary of these data
gaps is given in Table 1. Please note that this is only a
summary and complete details can be obtained by referring to
the tables in Appendix I.
The Regulatory Position and Rationale section of this
Registration Standard discusses the Agency's position on each
of the regulatory issues concerning fenitrothion and the Required
Labeling section contains the specific wording required for
each of the labeling provisions.
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TABLE 1. SUMMARY OF DATA GAPS
(Please refer to the tables in Appendix 1 for detailed
information regarding these requirements)
Toxicology
Subchronic oral toxicity—rodent species (for plasma
cholinesterase effects)
21-day dermal—rabbit
90-day inhalation—rat —^ ......
Oncogenicity—mouse
Teratogenicity—rat and rabbit
Reproduction—rat
Mutagenicity—(point mutation assay in mammalian cells, structural
chromosomal aberration, and other genotoxic effects)
Metabolism study
Special tests—acute and subchronic tests in rats for eye effects
Environmental Fate/Exposure
Hydrolysis study
Photodegradation in water, soil and air
Aerobic soil metabolism study
Anaerobic aquatic metabolism study
Lab volatility study
Leaching and adsorption/desorption
Soil dissipation study
Forestry dissipation study
Fish accumulation study
Applicator exposure studies
.Indoor air residue exposure study
Reentry data
[A field volatility study is reserved pending the results of
the lab volatility study; a long-term field dissipation study
will not be required if residues reach 50% dissipation prior to
the next recommended application; and an aquatic nontarget
organisms study is reserved pending the results of the fish
accumulation study.]
Fish and Wildlife
Avian reproduction
Actual field testing—birds and aquatic organisms
Acute toxicity to freshwater invertebrates—typical end-use product
Fish early life stage and aquatic invertebrate life cycle
[Pending the results of the environmental fate data and other
fish and wildlife tests, a fish life cycle may be required1. ••
Aquatic organism accumulation is reserved pending the results
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\ /
Table 1. (con't)
of the lower tier tests.] ;
Plant Testing Requirements
Seed germination/seedling emergence
Vegetative vigor
Aquatic plant growth
Residue Chemistry
Residue analytical methods
Storage stability
Residue data (wheat gluten)
Product Chemistry
All product chemistry studies
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B. PRELIMINARY HEALTH RISK ASSESSMENT
!
Numerous data gaps exist for fenitrothion and few definitive
conclusions can be made pending receipt of additional data.
The following preliminary health risk assessment is based on
the data available.
1. Acute Toxicity
There are adequate acute toxicity studies on file to
support registration of technical fenitrothion. Technical
fenitrothion is moderately toxic on an acute oral, dermal, and
inhalation basis. It falls in Toxicity Category II for oral
exposure based on acute oral toxicity values of 800 and 330 mg/kg
in female and male rats, respectively. It is in Toxicity
Category II for dermal exposure based on acute dermal toxicity
values of 1200 and 890 mg/kg in female and male rats, respectively,
It is in Toxicity Category III for inhalation exposure based
on an acute inhalation toxicity value of 5.0 mg/L in rats.
Technical fenitrothion possesses low skin and eye irritation
to mammals (Toxicity Category III for both). It has not been
shown to be a dermal sensitizer. Acute delayed neurotoxicity
studies in the hen showed negative results at dose levels of
500 mg/kg.
2. Subchronic Toxicity
An acceptable subchronic rat oral toxicity has not been
submitted to the Agency. The Agency is not making this a
requirement, however, since the results from a chronic feeding
study in the rat can be translated to this subchronic feeding
study. A subchronic oral dog study is also not available, but
this study is not needed, since there is an acceptable one year
chronic dog study on file with the Agency. Since fenitrothion
may be used on sites where significant dermal exposure may be
expected to occur, e.g. in greenhouses and domestic dwellings,
the Agency is requiring a subchronic dermal toxicity study and
a subchronic inhalation study. An acceptable subchronic
neurotoxicity study has been submitted to the Agency and shows
that fenitrothion does not induce delayed neurotoxicity.
3. Chronic Toxicity and Oncogenicity
Rats and Mice; A No Observable Effect Level (NOEL) for brain
and red blood cell cholinesterase of 10 ppm was determined
based on a study in which male and female Charles River
albino rats were fed dose levels of 10,30, and 100 ppm in the
diet for 104 weeks. The test material did not affect the
wide variety of parameters examined including appearance,
behavior, survival, hematological data, urinalysis, ophthalmology,
organ weights, and gross and microscopic examination. Under..
the conditions of the study, technical fenitrothion inhibited
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erythrocyte, plasma, and brain cholinestetase activity. The
inhibiting action was more pronounced in plasma when compared
with erythrocyte and brain activity. A NOEL for plasma cholin-
esterase was not determined; therefore, a 90-day study is
required to determine the NOEL for plasma cholinesterase. No
oncogenic effects were noted at the dose levels tested in this
study. This study satifies the requirement for a chronic/
oncogenicity study in a rodent species.
An oncogenicity study in the mouse showed that fenitrothion
is not oncogenic at a concentration of 200 ppm (30.0 mg/kg).
However, the Agency has rereviewed this data, and has determined
that due to design deficiencies, the study is now considered
unacceptable.
Dogs: In a chronic feeding study in which beagle dogs were
fed technical fenitrothion at dietary levels of 0, 5, 10
or 50 ppm for 52 weeks, the test material did not affect
the wide variety of parameters examined (hematology, clinical
chemistry, urinalysis, clinical observations, ophthalmology,
body weight, food consumption, organ weights, and mortality).
Under the conditions of the study, technical fenitrothion
inhibited plasma cholinesterase activity significantly in male
and female dogs at the 10 and 50 ppm levels. Red blood cell
or brain cholinesterase activities were not affected. In male
dogs, there was a mild elevation of blood cholesterol at the
highest dose. Histopathology data, recently submitted to the
Agency, indicated that the administration of fenitrothion
resulted in an increased incidence of abdominal lymph node
hemorrhage in 2/6 female dogs at 10 ppm and 2/6 females and
1/6 male dogs at 50 ppm. Abdominal lymph node hemorrhage was
not observed in males or females at 5 ppm. The systemic NOEL
for this study, based upon inhibition of plasma, is 5 ppm. The
Lowest Observable Effect Level (LOEL) is 10 ppm based on plasma
cholinesterase activity inhibition.
4. Metabolism
There are no adequate metabolism studies available for
technical fenitrothion. Preliminary data indicate that 14C
fenitrothion administered to male and female Wistar rats, male
and female rabbits, or male beagle dogs, as a single oral dose
at 15 mg/kg, was rapidly absorbed and excreted. Excretion of
l^C fenitrothion was nearly complete in 48 hours postadministra-
tion with approximately 90 and 5 per cent of the excreted dose
eliminated in the urine and feces, respectively. Expired air
from rats contained no radioactivity and 14C levels in the
tissues were not measured. No sex or species related differences
in the total excretion were apparent. In rats, a higher single
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dose (105 mg/kg) or pretreatment with unlabeled fenitrothion
for 5 days did not alter the excretion profile. Seventeen
metabolites were isolated from the rats, rabbits and dogs,
of which eight were identified. The parent compound was not
detected in the urine of any animal. In the feces, no metabolites
other than those found in the urine were present. This study
does not fulfill Agency guideline requirements because the
methodology and materials^ were poorly or
The source, age, weight, and number of anima-ls tested were
not reported in some instances. Data on the tissue distribution
of l^C were inadequate to determine the total recoveries of
dose radioactivity. Therefore, a metabolism study (low dose,
high dose, and multiple dose) is required to support registra^__
tion of fenitrothion products.
5 . Mutagenicity
The Agency has reviewed the available data on the
mutagenicity of fenitrothion and is unable to draw definitive
conclusions on its mutagenic potential. Fenitrothion is
not considered to be a potential mammalian mutagen, based on
an acceptable reverse mutation assay in Salmonella typhimurium.
To complete regulatory requirements for mutagenicity testing,
the Agency is requiring additional studies; specifically, gene
mutation in mammalian cells, structural chromosomal aberrations,
and other genotoxic effects, e.g. numerical chromosomal aberrations
or direct DNA damage/repair.
6. Teratology
A rat teratology study is required to support registration
of fenitrothion products. Based on preliminary data, fenitrothion
administered in daily oral doses up to 20 mg/kg to rats during
the gestation days 9 to 14 was found to be neither embryotoxic
or teratogenic. This study, previously considered as adequate
under the Agency's Data Call-in Program for chronic studies,
is now considered to be inadequate. The reason for this is
that the pregnant rats were treated from days 9-14 of gestation
instead of days 6-15 of gestation as called for in the Pesticide
Assessment Guidelines Subdivision F. Based upon preliminary
data from another teratology study, technical fenitrothion
administered in daily oral doses up to 20 mg/kg/day to mice
during gestation days 7 to 12 was found also to be neither
embyrotoxic or teratogenic. This study is considered to be
inadequate for the same reason as given for the rat study.
In response to the Agency's 1984 Data Call-in for feni-
trothion, a rabbit (albino) teratology study was submitted in
which treatment-related changes in maternal body weight, mortality
or behavior were noted. Fetal mortality, number of implantation
sites, resorptions, abortions, external development, f eta-1 ..
body weights, viability of young during incubation, internal
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development or skeletal development were not affected. This
study was not considered to be adequate because there were too
few litters/dose/ inadequate data was submitted, there was no
maternal toxicity and there were no historical controls. A
new rabbit teratology study was submitted in 1986, and is
determined to be unacceptable because semen from more than one
strain of rabbit was used to artificially inseminate the does.
Due to possible genetic differences in the strains of rabbits
used, it is impossible to determine whether fetal effects were
due to treatment or parental genetics. Therefore, a new rabbit
teratology study is required.
7. Reproduction
A reproduction study is required to support registration
of fenitrothion products. Results of preliminary data using
technical fenitrothion, in which rats were administered doses
of 10, 30, and 150 ppm in the diet through weaning of the first
filial generation, and 10, 30, and 100 ppm thereafter, revealed
body weight reduction at 150 ppm to the P]_ generation and 100
ppm in the ?2 generation. The lactation index was significant-
ly depressed for the filial generations at the highest dietary
levels of fenitrothion. At the 150 and 100 ppm levels, weaning
body weights of both sexes of the F^A, males of the F^B, and
both sexes of the F2A generations were significantly lower
than the control values. This study, previously considered to be
adequate under the Agency's Data Call-in Program, is now
considered to be inadequate because the study was not performed
in accordance with the Pesticide Assessment Guidelines F.
8. Ocular Effects
In Japan, organophosphates have been observed to produce
toxic effects to the eye. In the 1950's and 1960's, Japanese
workers noted extensive human poisonings by organophosphate
pesticides producing a syndrome of effects on vision ranging in
severity from myopia, which could be corrected optically, to
congestion or degeneration of the optic nerve (it is not known
if fenitrothion was one of these pesticides). These myopic
effects were later duplicated in experimental studies of
organophosphates, including fenitrothion, in dogs. In the
fenitrothion study, fenitrothion was administered to dogs for
one year at doses of 5 to 50 mg/kg twice weekly, and observed
for a year thereafter. Myopia with vertical astigmatism was
detected by measuring the shape of the refractive surface of
the eye. A reduction in acetylcholinesterase activity was the
only additional sign of toxicity. Histopathology revealed a
dose-related destruction of the ciliary muscle. In addition,
in rat studies using structurally related organophosphates,
ethyl parathion, methyl parathion and fenthion, a progression.
of effects, from functional abnormalities in electrical activity
at low acute doses to retinal degeneration at higher doses,
were noted.
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To confirm the effect of fenitrothion on the eye, the
Agency is requiring special acute and subacute rat studies.
Upon receipt and evaluation of these data, the Agency will
determine whether labeling modification or other regulatory
action is warranted.
9. Occupational Exposure Risk
The Agency is unable to fully assess the risk from use of
fenitrothion to handlers (mixers, loaders, applicators, etc.) and
persons entering treated areas after application. Fenitcothion
is a cholinesterase-inhibiting organophosphate pesticide in
Toxicity Category II and a possible cause of human occular
effects. However, exposure data on fenitrothion are unavaila-
ble and surrogate exposure data are inadequate for this
purpose. The Agency believes that exposure to handlers of
fenitrothion is possible, especially at forest sites during
hack-and-squirt application and at greenhouse/nursery ornamental
sites during foliar spray application. Exposure to persons
performing activities in treated areas of nurseries and green-
houses following application is also possible.
C. ENVIRONMENTAL PROFILE
1. Avian Species
Based on acceptable laboratory data, technical fenitrothion
is characterized as highly toxic to upland gamebirds and slightly
toxic to waterfowl on an acute oral basis. The single-dose
oral toxicity values to bobwhite quail and mallards was determined
to be 23.6 mg/kg and 1190 mg/kg, respectively. Based on acceptable
subacute dietary studies in birds, technical fenitrothion is
characterized as highly toxic to upland gamebirds and slightly
toxic to waterfowl, with a subacute toxicity value of 157 ppm
for bobwhite quail and 2482 ppm for mallards.
Avian species may be exposed to fenitrothion as a
result of its forestry use pattern, e.g. aerial treatment for
spruce budworm control and bark application for southern
pine bark beetle control. Exposure may occur through direct
contact (inhalation and dermal routes), or through ingestion
of contaminated foodstuffs (e.g. ingestion of insects by
insectivorous birds). Several reports available to the Agency
give suggestive evidence that substantial mortalities to upper
canopy birds (passerines) may have resulted from operational
spraying of fenitrothion in forests to control the spruce
budworm. In one report, as many as 2.5 million birds, mainly.
passerines, may have been killed from 1.8 million hectares
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of forest treated with fenitrothion. The forest use pattern
to control southern pine bark beetle does not have any actual
field studies to suggest hazards from this use pattern, although
insectivorous birds could be at a high risk.
The observed hazard to-birds resulting from spruce
budworra control sprayings is not consistent with the results
of acceptable laboratory toxicity information. For example,
the maximum estimated residue resulting from two treatments at
the maximum label rate for spruce budworm control (3 oz. active
ingredient per acre per treatment) assuming no degradation or
dissipation in the interval between treatments (generally 5 to
7 days) is 75 ppm on foliage. This residue concentration is
less than one-half the avian dietary acute toxicity value for
bobwhite quail (157 ppm). Residues on insects and seeds, food-
stuffs which are most attractive to small passerines, would
be less than 20 ppm. Although this information conflicts with
the reported bird mortalities, various reasons may account for
this phenomenon. For one, the species mostly affected, passer-
ines, may be more susceptible to fenitrothion than are upland
gamebirds. Secondly, the birds may have an added pesticide
susceptibilty resulting from the dermal and inhalation routes
of exposure. Finally, greater exposures could have resulted
from misapplication or overlapping spray swaths during treatment.
None of the field studies on aerial operational spraying
of fenitrothion in forests are sufficient to allow a definitive
assessment of the field effects of Eenitrothion to birds.
The studies do, however, demonstrate a definite pattern ot
adverse effects attributable to fenitrothion occuring to birds.
The exact magnitude of these impacts cannot be ascertained by
the existing data due to the limited scope of the conducted
studies and the lack of sufficient detail in the studies
concerning methods and results. For this reason, the Agency
is requiring a comprehensive field study to quantify effects
on avian species to determine if the hazard indicated by the
available field evidence is ecologically significant.
2. Aquatic Species
Sufficient information is available to characterize fenitro-
thion as moderately toxic to both warmwater and coldwater
fish, and very highly toxic to aquatic invertebrates. The
96-hour acute toxicity value for brook trout, a coldwater
species, is reported to be 1.7 ppm, and the 96-hour acute
toxicity value to bluegill, a warmwater species, is reported
to be 3.8 ppm. The 96-hour acute toxicity values for freshwater
invertebrates is reported to be 3 ppb for the amphipod Gamma-rus
fasciatus.
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Aquatic organisms may be exposed to fenitrothion from
aerial treatment for spruce budworm control and from run-off
resulting from bark treatment to control southern pine bark
beetles. Direct application to water from a single spruce
budworm treatment at the minimum rate (2 oz. a.i. per acre)
would result in 92 ppb in 6 inches of water and 15 ppb in
3 ft (.1 m) of water. The most sensitive fish (brook trout)
has a 96-hour acute toxicity value of 1.7 ppm and the most
sensitive aquatic invertebrate (G. fasciatus) has a 96-hour
acute toxicity value of 3 ppb. Based on these theoretical
calculations, aquatic invertebrates would be expected to be
substantially impacted from operational sprayings of fenitro- —
thion. This presumption is supported by several field studies
which have reported population reductions in many aquatic
invertebrate groups. Based on theoretical calculations, run-off
resulting from treatment of fenitrothion for the control of
bark beetles can also result in an exposure level greater then
1/2 the aquatic invertebrate acute toxicity value, although
actual field data are not available for confirmation.
Additional data are necessary to ascertain the exact
magnitude of the impact to aquatic invertebrates. The available
evidence is not considered adequate for assessing the magnitude
ot the observed aquatic fauna losses. For this reason, the
Agency is requiring a comprehensive aquatic study to quantify
effects on aquatic invertebrate species to determine if the
hazard indicated in the available field evidence is ecologically
significant and whether the Agency should take additional
regulatory action.
3. Restricted-Use Classification
Since the forestry uses of fenitrothion (spruce budworm
and southern pine beetle) potentially cause adverse effects on
avian and aquatic invertebrate species, the Agency is restricting
these uses to certified applicators or persons under their
direct supervision on an interim basis pending submittal and
evaluation of the required terrestrial and aquatic field studies.
4. Honey Bees
There is sufficient information to characterize fenitrothion
as highly toxic to honey bees (acute toxicity value = 0.383
ugs. per bee) when bees are exposed to direct treatment or to
dried residues on foliage. Precautionary labeling is required
for all fenitrothion products intended for outdoor applications.
5. Effects on Plants
Non-target plant data are required for pesticides with .a .
forestry use pattern. Tier I data on seed germination/seedling
emergence, vegetative vigor, and aquatic plant growth are
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required. No data are available to the Agency to satisfy
these requirements.
6. Endangered Species
The Agency has determined that the forestry use pattern
of fenitrothion may cause sufficient exposure to pose a direct
toxicity hazard to endangered and threatened terrestrial and
aquatic species. Labeling which prohibits the use of fenitrot-
hion in the range of endangered and threatened species are
required separately through a PR Notice. In addition, the
Agency is imposing additional labeling requirements through
this Standard, based on a 1981 formal biological opinion receiv-
ed by the Agency from the Office of Endangered Species (OES)
in regard to the use of fenitrothion to control southern pine
beetles. OES recommended that a statement be included under
the use directions warning against the use of fenitrothion
within 1/2 mile of red-cockaded woodpecker colonies. OES
also recommended against the use in Bastrop and Burleson Counties,
Texas without first contacting personnel of the Texas Parks and
Wildlife Service in charge of endangered species in order to
to protect the Houston toad. These recommendations have been
incorporated on product labeling for this use pattern. Formal
consultation has been reinitiated with OES to ensure that this
recommendation, and the opinion of no jeopardy for sixteen
species considered in the consultation, are still valid.
7. Environmental Fate
The Agency is unable to fully assess the environmental fate
of fenitrothion because acceptable data are lacking. Prelimin-
ary data indicate that fenitrothion degrades fairly rapidly in
soil with a half-life of less than a week in non-sterile muck
and sandy loam soils. Preliminary data also suggest that
fenitrothion is low to intermediately mobile in a variety of
soils ranging in texture from sandy loam to clay.
To assess the environmental fate of fenitrothion in
conjunction with its forestry and domestic outdoor use pattern,
the Agency is requiring the following studies: hydrolysis;
photodegradation studies in soil and water; aerobic and
anaerobic soil metabolism; aerobic soil and anaerobic aquatic
metabolism; leaching and adsorption/desorption; terrestrial
field dissipation; forestry dissipation; lab volatility; and
fish accumulation. The requirement for a field volatility study
is reserved pending the results of the lab volatility study.
A long-term field dissipation study will not be required if
residues reach 50 percent dissipation prior to the next
recommended application. The requirement for an accumulation-
study in aquatic nontarget organisms is reserved pending the
results of the laboratory fish accumulation study.
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The potential for groundwater contamination cannot be
assessed because acceptable aerobic and anaerobic degradation
data and mobility data are lacking. When acceptable environmental
fate data are received, the Agency will assess the potential
for fenitrothion to contaminate groundwater.
E. TOLERANCE REASSESSMENT
1. Tolerances Issued
There are no domestic uses for fenitrothion on food or
feed commodities. There is one established U.S. food additive
tolerance which covers residues of fenitrothion in wheat gluten
imported from Australia arising from the stored wheat grain
treatment registered in that country (2 CFR 193.156[9]). The
tolerance level is set at 30 ppm for the combined residues of
fenitrothion, fenitrooxon, and p-nitrocresol, of which no more
than 15 ppm is fenitrothion or fenitrooxon. In Australia, a
50% EC may be applied to wheat grain to be stored at the rate
of 6.6-13.2 milligram of active ingredient per kilogram of
grain. Application is to be made at the time of conveyor belt
delivery of the grain to bulk storage facilities. Treated
grain is to be held in storage and not to be used for processing
into food for human consumption or for animal feed, until the
fenitrothion residue has decreased to below 10 ppm or until 3
months have elapsed. Codex MRLs (Maximum Residue Limits) for
fenitrothion have been established on numerous plant and animal
commodities although no U.S. tolerances exist.
2. Residue Data
The residue data reviewed in support of the fenitrothion
tolerance for wheat gluten are as follows:
a. The nature of fenitrothion residues in plants is
adequately understood based upon available rice metabolism
and degradation data. The submitted data indicate that
fenitrothion per se (I), desmethyl fenitrothion (IV), and
p-nitrocresol (VII) are the major components of the residue in
cice grain 0-9 months after postharvest treatment with fenitrothion.
Additional metabolites/degradates retaining the aryl phosphate
phosphorothioate moiety which are present in very small amounts
(i.e., collectively less tha 3% of the total l^C-residue in
the grain) were fenitrooxon (II), fenitrothion S-isomer (III),
desmethylfenitrooxon (V), and desmethyl fenitrothion S-isomer
(VI). Another metabolite/degradate, which does not contain
the phosphate moiety but which accounted for up to approximately ...
7% of the l^C-residue in rice grain was MMNB (IX). No metabolites
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are considered to be of toxicological significance at this
time.
b. Animal metabolism studies are not available for
fenitrothion. These studies are not required, since fenitrothion
is not federally registered for use on any domestic crops; and
therefore residues are not expected to enter the diet of food
animals. In the event that future federal registrations for
use of fenitrothion on plant commodities used for animal feeds
are established, or regulations covering importation of animal
products from countries in which fenitrothion is registered
for use are established, additional animal metabolism studies
may be required.
c. Analytical methodology for determining levels of
residues of fenitrothion, fenitrooxon, and p-nitroccesol in
plants is adequate for data collection and tolerance enforcement
purposes, with the exception that residues of p-nitocresol in
or on samples of wheat gluten must be subjected to analysis by
multiresidue protocols.
d. Storage stability data are required to support the
wheat gluten tolerance. Storage intervals and conditions must
be reported from the samples used to generate residue data
submitted in support of the tolerance. Data must be provided
which depict the decline in residues during the storage
intervals and under the conditions reported.
e. Data are inadequate to support the established tolerance
for fenitrothion residues in wheat gluten. Data depicting the
residues of fenitrothion, fenitooxon, and p-nitrocresol in or on
wheat grain held in storage in commercial grain silos for 90
days following an application at the time of the conveyor belt
delivery of the 50% EC at 13.2 mg active ingredient of grain,
are required. In addition, data depicting whether residues of
fenitrothion, fenitrooxon, and p-nitrocresol concentrate in
bran, flour, middlings, shorts, and gluten processed from
wheat grain bearing measurable weathered residues must be
submitted. This information must be accompanied by product
labels detailing the use instructions and limitations for
fenitrothion on wheat in Australia.
3. Acceptable Daily Intake
A provisional acceptable daily intake (PADI), based on
a one-year dog study with a No-Observable Effect Level (NOEL)
of 0.125 mg/kg/day, and using a 30-fold safety factor, is
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calculated to be 0.004 mg/kg/day. A comparision of the
published tolerance to the PADI was conducted using the TAS
Routine Chconic Analysis. Based on the analysis, a Theoretical
Maximum Residue Contribution (TMRC) for the U.S. population
was calculated to be 0.000038 mg/kg/day, which utilizes 0.94
per cent of the PADI.
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IV. REGULATORY POSITIONS AND RATIONALES
A. SUMMARY OF REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on fenitrothion the Agency has made
the following determinations:
1. No referral to Special Review is being made at this
time.
Rationale (fish and wildlife): The Agency is concerned
over the potential adverse impact of fenitrothion on birds and
aquatic organisms resulting from the forestry use pattern.
The Agency has received reports on both bird and aquatic inverte-
brate kills resulting from aerial spray operations. Terrestrial
residue analysis and run-off modeling further indicate that
these species could be exposed to potentially hazardous levels
of the pesticide. Additional data are needed before the Agency
can complete a full assessment of this hazard. For these
reasons, the Agency is requiring comprehensive aquatic and
terrestrial field studies to determine if the hazard indicated
by the available field evidence is ecologically significant.
Upon receipt and evaluation of these studies, the Agency will
determine if labeling modifications or other regulatory action
is warranted.
Rationale (eye effects): Studies available to the
Agency have implicated the organophosphates in general, and
fenitrothion in particular, in such human eye effects as retinal
degeneration and myopia. Because of this concern, the Agency
is requiring submission of special rat acute and subchronic
studies, such as electroretinograms and direct corneal measure-
ments. These data will provide additional information necessary
to confirm the potential for fenitrothion to cause retinal
degeneration and changes in corneal shape and structure in the
human eye. Pending receipt and evaluation of these studies,
the Agency will determine whether labeling modifications or
other regulatory action is warranted.
2. All forestry uses of fenitrothon are restricted for
use by certified applicators or persons under their direct
supervision on an interim basis pending submission and evaluation
of the required terrestrial and aquatic field studies.
Rationale: Section 3(d)(l)(C) of the FIFRA provides
that some or all uses of a pesticide will be classified for
restricted use if the Administrator determines that without such
restriction the pesticide "may generally cause unreasonabl-e.. .
adverse effects on the environment". For fenitrothion, the Agency
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has determined that the forestry uses (spruce budworra and
southern pine beetle) potentially cause adverse effects on
avian and aquatic species. This determination is based upon
the bird and aquatic invertebrate kills resulting from aerial
spray for spruce budworm control; and terrestrial residue
analysis and run-off modeling" indicating that these species
could be exposed to potentially hazardous levels of the pesticide.
3. The Agency has determined that endangered species label
restrictions are necessary to protect endangered and threatened
species in forest areas. Through a separate PR Notice 87-4,
the Agency is requiring endangered species labeling for all
end-use fenitrothion products registered with a forestry use
pattern. In addition, the Agency is imposing labeling require-
ments through this Standard to protect the red-cockaded
woodpecker and Houston toad.
Rationale; Fenitrothion is highly toxic to fish and.
other wildlife. The Agency is limiting the use of fenitrothion
in forests where its use has been identified to endanger or
jeopardize terrestrial and aquatic species through a separate
PR Notice 87-4. In addition, the Agency is imposing additional
labeling requirements to protect the Houston toad and. red-cockaded
woodpecker through this Standard. This is based upon a biological
opinion received from the Office of Endangered Species in 1981
regarding the use of fenitrothion to control southern pine
beetles in pine forests. OES recommended a statement be included
under the directions for use warning against the use of fenitrothion
within 1/2 mile of red-cockaded woodpecker colonies, and that
a statement be' included warning that use in Bastrop and Burleson
Counties, Texas should occur only after contacting personnel
of the Texas Parks and Wildlife Service or the U.S. Fish and .
Wildlife Service in charge of endangered species to ensure
that adequate safeguards are in place to protect the endangered
Houston toad. These recommendations have been incorporated on
labeling for this use pattern. The Agency has reinitiated
consultation with the Office of Endangered Species (OES), U.S.
Department of the Interior to ensure that this recommendation
and the opinion of no jeopardy for sixteen species considered in
the consultation, are still valid.
4. In order to meet the statutory standard for continued
registration, the Agency has determined that fenitrothion
products must bear fish and wildlife toxicity warnings.
Rationale; Labeling requirements are imposed since
available data indicate that fenitrothion is very highly toxic to
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5. The Agency is deferring decisions concerning fenitrothion
groundwater contamination until such time as the information
required by the Standard have been submitted and reviewed.
Rationale; Groundwater contamination may not be a
potential threat because preliminary data indicate rapid degra-
dation of fenitrothion (half-life of 2 to 8 hours in soil). How-
ever/ the environmental fate of fenitrothion is largely
uncharacterized, and additional data are needed in order for
the Agency to fully assess its fate in the environment. When
these, and other environmental fate data are received and
evaluated, the Agency will assess fenitrothion1s potential for
groundwater contamination.
6. The Agency is requiring special indoor air residue
monitoring studies to support fenitrothion1s use to control
adult Anopheline mosquitoes in human dwellings.
Rationale; Inhalation and dermal exposure to occupants
of treated dwellings may occur from use of the 40% wettable
powder formulation to control adult Anopheline mosquitoes.
The Agency does not have any residue data to support the safety of
this use. A special indoor air residue monitoring study is
required to support continued use of this product. The study
must be designed to evaluate any decline in air residues over
time to determine if a reentry time is appropriate.
7. No new tolerances or new food uses will be granted
until the Agency has received data sufficient to evaluate the
dietary exposure of fenitrothion.
Rationale; Residue chemistry and toxicology data
are not sufficient to allow the Agency to assess the existing
tolerance for wheat gluten. Residue analytical methods, storage
stability data, and residue data are required. The pertinent
toxicology data requirements include: mouse oncogenicity,
teratology, reproduction, metabolism, and mutagenicity. Until
these data are submitted and reviewed, the Agency cannot perform
a tolerance reassessment.
8. The Agency is requiring submission of applicator
exposure data, and is imposing an interim 24 hour reentry
interval for fenitrothion products intended for use on
greenhouse and nursery ornamentals pending receipt and
evaluation of reentry data. Protective clothing statements
as specified in Section IV.D. are required for all products
containing fenitrothion.
Rationale; In order to evaluate the risk of occupational
exposure to fenitrothion, dermal and respiratory exposure
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monitoring studies of applicators and reentry protection data
are necessary/ in addition to the toxicological studies discussed
above. Until such studies are submitted and evaluated, interim
protection of workers is necessary. Appropriate personal
protective equipment during handling of fenitrothion should
significantly reduce handler exposure risks. In addition,
prohibition of reentry without appropriate personal protective
equipment for 24 hours after application to greenhouse and
nursery sites should significantly reduce risk to early reentry
workers.
9. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing fenitrothion may be sold, distributed, formulated,
and used, subject to the terms and conditions specified in
this Standard. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency may elect not to
cancel or withhold registration even though data are missing or
are inadequate (see FIFRA sections 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory actions
are necessary.
10. The Agency has identified certain data that will
receive priority review when submitted to the Agency.
Rationale: Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may 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:
§158.135 Toxicology
Special acute and subacute rat tests for
ocular effects
§158.130 Environmental Fate
161-1 Hydrolysis
161-2 Photodegradation in water
161-3 Photodegradation on soil
161-4 Photodegradation in air
164-1 Soil dissipation
164-3 Forestry dissipation
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165-4 Fish accumulation
Applicator Exposure Studies
Indoor air residue monitoring study
§158.140 Reentry Protection
132-1 Foliar Dissipation
133-3 Dermal Exposure
133-4 Inhalation Exposure
§158.145 Wildlife and Aquatic Organisms
71-5 Actual field testing- birds and aquatic organisms
72-4 Fish Early Life Stage and Aquatic Invertebrate
Life Cycle
§158.125 Residue Chemistry
All Requirements
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, MPs
must contain fenitrothion as the sole active ingredient (solvents
or diluents are not considered to be insecticidal, and therefore,
must be declared as inerts). Registrants must comply with all
terms and conditions described in this section, including
submission of an up-to-date Confidential Statement of Formula,
submission of revised labeling, commitment to fill data gaps on
the schedule specified by the Agency and, when applicable, offer
to pay compensation as required by FIFRA sections 3(c)(l)(D) and
3(c)(2)(D).
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Each MP proposed for registration or reregistration must
be fully described with an appropriate certification of limits,
stating maximum and minimum amounts of the active and inten-
tionally added inert ingredients which are present in the product,
as well as impurities found at greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of MPs containing
fenitrothion in any Toxicity Category provided the product labeling
bears appropriate precautionary statements for the acute toxicity
category in which each product is placed.
3. Use Patterns
All MPs must be labeled for formulation into other
manufacturing-use products or into end-use products bearing
federally registered uses. Labeling must specify the sites,
which are listed in Use Patterns, Appendix III. However, no
use may be included on the label where the registrant fails to
agree to comply with the data requirement in Table A for that
use pattern.
D. REQUIRED LABELING
All MPs and EPs must bear appropriate labeling as specified
in 40 CFR 162.10, PR Notices 83-2 and 83-3, and as indicated in
this Registration Standard (as appropriate). No EP or MP con-
taining fenitrothion may be released for shipment by a registrant
or producer of that product 12 months after the registrant's or
producer's receipt of this Registration Standard, unless the
product bears an EPA-approved amended label which complies with
this Registration Standard.
»
No EP or MP containing fenitrothion may be distributed, sold,
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offered for sale, held for sale/ shipped, delivered for shipment,
or received and (having been so received) delivered or offered
to be delivered by any person 24 months after issuance of this
Registration Standard, unless the product bears an EPA-approved
amended label which complies with this Registration Standard.
1. Labeling for MPs
a. The ingredient statement for MPs must declare the
active ingredient as:
Fenitrothion: 0,0-dimethyl 0-(4-nitro-m-tolyl)
phosphorothioate
b. Labels for MPs must bear the following identifying
phrase directly beneath the product name:
"An insecticide for formulating use only."
c. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated product."
d. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide products
intended only for (list acceptable sites ) ."
NOTE: No use may be included on the label where the
registrant fails to agree to comply with the data requirements
for that use pattern.
e. If detailed instructions for formulating are not
provided on the label, the following statement must appear:
"Refer to attached Technical Bulletin for formulating
and other information."
NOTE: The technical bulletin must be submitted with the
product label for Agency review.
f. The following fish and wildlife statements are required
to appear under the "Environmental Hazards" heading:
"This pesticide is extremely toxic to aquatic invert-
ebrates. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public waters
29
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unless this product is specifically identified and addressed
in 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 EPA."
g. The following worker protective clothing statement
is required to appear on the label:
"Mixer/loaders must wear goggles or a face shield,
chemical-resistant apron, long-sleeved shirt and long pants, or
coveralls, and unlined, mid-forearm to elbow length chemical-
resistant gloves when mixing, loading, or otherwise handling
concentrate."
1. Labeling for EPs
a. The ingredient statement for EPs must declare the
active ingredient as:
Fenitrothion: 0,0-dimethyl 0-(4-nitro-m-toly1)
phosphorothioate
b. The following statement must appear on the front
panel of end-use labeling for the forestry uses (spruce bud-
worm and southern pine beetle):
"RESTRICTED USE PESTICIDE
Due to Avian Toxicity and Aquatic
Invertebrate Toxicity
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."
c. The wettable powder formulation intended for use
as a residual spray in residential dwellings to control adult
Anopheline mosquitoes must bear the following statements:
"Remove occupants, pets, birds, and cover fish
aquariums before application. Food should be removed and food
handling equipment covered during application and/or washed
after application is complete. No food handling or preparation
areas are to be sprayed. The floor area must be covered before
application and the covering disposed of in accordance with
disposal procedures specified on this label. After application
do not reoccupy until spray deposits have dried. Do not make
more than one application every three months. Before reoccupying,
open, all doors and windows and ventilate thoroughly."
d. All products (except the wettable powder formulation.)
intended for use indoors must bear the following statements:
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"Do not apply this product in edible product areas of
food processing plants, restaurants, or other areas where food
is commercially prepared or processed. Do not use in serving
areas while- food is exposed. Do not use in kitchens or food
serving areas while food is exposed. When used in dwellings,
avoid deposits which could be frequently contacted by children.
Do not permit children or pets in treated areas until surfaces
are dry.
e. All products intended for wide area outdoor use,
e.g. forestry use, are required to bear the following statement:
"Do not treat areas where food or feed crops are
growing. Do not apply to potable water."
f. All products intended for outdoor use for spruce
budworm control must bear the following statements:
"This pesticide is toxic to wildlife and extremely
toxic to aquatic invertebrates. Do not apply directly to water
or wetlands (swamps, bogs, marshes, and potholes) except under
the forest canopy. Drift and runoff from treated areas may be
hazardous to aquatic organisms in neighboring areas. Do not
contaminate water by cleaning of equipment or disposal of
wastes. This product is highly toxic to bees exposed to
direct treatment or residues on blooming crops or weeds. Do
not apply this product or allow it to drift to blooming crops
or weeds if bees are visiting the treatment area."
g. All products intended for outdoor use (except for
spruce budworm control) must bear the following statements:
"This product is toxic to wildlife and extremely"
toxic to aquatic invertebrates. Do not apply directly to
water or wetlands (swamps, marshes, bogs, and potholes).
Drift and runoff from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water by
cleaning of equipment or disposal of wastes. This product is
highly toxic to bees exposed to direct treatment or residues
on blooming crops or weeds. Do not apply this product or
allow it to drift to blooming crops or weeds if bees are visiting
the treatment area."
h. The following endangered species labeling for
fenitrothion products intended for southern pine bark beetle
control must also appear on the labeling (in addition to the
requirements of the PR Notice 87-4):
"Do not use in Bastrop and Burleson Counties,
Texas without first consulting with endangered species personnel
of Texas Parks and Wildlife or the U.S. Fish and Wildlife
Service (telephone 817-334-2961) to ensure adequate safeguards -
for the endangered Houston toad. Do not use within 1/2 mile
of known red-cockaded woodpecker colonies. Contact the U.S.
Fish and Wildlife Service before using this product."
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i. The following worker protection statement must appear
on all fenitrothion product labels (excluding greenhouse and
nursery ornamental use):
"When mixing, loading, spraying or cleaning
equipment used to apply this-product wear chemical resistant
gloves, protective suits or coveralls that cover the arms,
legs, and torso, and chemical resistant shoes, boots, or shoe
covers. Chemical resistant gloves must be washed with soap
and water before removing. All clothing worn during the use
of fenitrothion must be laundered separately from household
articles. Clothing and protective gear drenched or heavily
contaminated with fenitrothion must be destroyed according
to state and local regulations. Drenched or heavily contaminated
clothing cannot be properly decontaminated. [Aircraft
operators: Pilots can wear long-sleeved shirt and long-pants
but must have a clean pair of chemical resistant gloves
available for exiting the aircraft.]"
j. The following reentry statement and protective
clothing statements must appear on all fenitrothion products
intended for use on greenhouse and nursery ornamentals:
"Reentry into treated areas is prohibited for
24 hours after the end of the application, unless the pro-
tective clothing specified on this label is worn. When mixing,
loading, spraying or cleaning equipment, or during early
reentry into treated areas, wear chemical resistant gloves,
protective suits or coveralls that cover the arms, legs, and
torso, and chemical resistant shoes, boots, or shoe covers.
Chemical resistant gloves must be washed with soap and water
before removing. All clothing worn during the use of fenitrothion
must be laundered separately from household articles. Clothing
and protective gear drenched or heavily contaminated with
fenitrothion must be destroyed according to state and local
regulations. Drenched or heavily contaminated clothing cannot
be properly decontaminated.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one -or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a jnanufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use/ composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it . ..
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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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A and B
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 formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D.. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
c. The labeling requirements specified for end use
^If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
speciiiic data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Ag.ency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in' ••
an agreement and the 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 that you may rely upon its submission.
36
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium/ a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
37
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement doesnot (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
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 timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate •
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
39
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the .data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a 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 in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granti-ng
40
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it 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
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix.II - LABELING and SUMMARY). In
addition, labeling requirements specific to products contain-ing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be .. .
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
42
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label/ clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table -A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
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C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
i
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in
8-1/2 x 11 files. The draft labeling must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type sizes
of the text. End use product labeling must comply specifically
with the instructions in Section IV (Regulatory Position
and Rationale).~
D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
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E. Addresses
The required information must be submitted to the following
address:
William H. Miller (PM 16)
Registration Division .(TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St. ,_SW
Washingt6rTrT>.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
45
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APPENDIX I
DATA APPENDICES
46
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TGUIDE-1
v GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 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
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 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
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor • -• .
I = Indoor
N/A = There are no registered use patterns for which the
data requirement aplies.
r 47
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\ TGUIDE-2
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 in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the 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 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the receipt date of the Regis-
tration Standard. The timeframes are those established either.
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
" 48
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TABLE A
GENERIC DATA REQUIREMENTS FDR FENITRDTHION
Data Requirement
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Product Ingredients:
Test
Substance
TGAI
TGAI
TGAI
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods TGAI
to Verify Certified
Limits
Physical and Chemical Characteristics:
63-2 - Color
63-3 - Physical State
TGAI
TGAI
Must Additional Timef rame
Use Does EPA Bibliographic Data be for
Patterns Have Data?^/ CitationV Submitted? Submission^/
-*
All . Yes 9 Months
All Yes 9 Months
All Yes | 9 Months
f '
All Yes 12 Months
All Yes 12 Months
All Yes 12 Months
All Yes 9 Months
All Yes 9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITRDTHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data? V
Must Additional Timeframe
Bibliographic Data be for
Citation^/ Submitted? Submission^/
§158.120 Product Chemistry (cont'd)
^
Physical and Chemical Characteristics:
(cont'd)
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
All
All
All
All
All
All
All
All
Yes
YesV
Yes4/
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Month
9 Months
9 Months
9 Months
9 Months
9 Months
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64-1 - Submittal of Samples
TGAI
TGAI
TGAI, PAI
All
All
All
Yes
Yes
ReservedV
9 Months
15 Months
(8 Months - Progress
Report)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Must Additional Timeframe
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Patterns Have Data?V CitationV Submitted? Submission^/
§158.120 Product Chemistry (cont'd)
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Required if the technical is a solid at room temperature.
Required if the technical is a liquid at room temperature.
If samples are needed, the Agency will request them.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENITRDTHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data
Must Additional Timeframe
Bibliographic Data be for
Citation Submitted? Submission*/
158.125 Residue Chemistry
171-4 Nature of the Residue
(Metabolism)
Plants
Animals
PAIRA
PAIRA
A2/
Yes
Partially
00069962
00069963
00113146
00071860
00150220
No
ReservedV
171-4 Residue Analytical
Methods
- Plant Residues
TGAI and A
metabolites
Partially
00062928
00113146
00135034
YesV 18 Months
(8 Months - Progress
Report)
171-4 Storage Stability
Data
171-4 Magnitude of the
Residue:
0 Wheat Gluten Imported
FRom Australia
TEP and A
metabolites
TEP
Partially
Partially
00150219
00150223
00113146
00150224
YesV 18 Months
(8 Months - Progress
Report)
Yes£/ 24 MonthsV
(8 Months - Progress
Report)
Ul
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Must Additional Timeframe
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data
Bibliographic
Citation
Data be
Submitted?
for
Submission^/
§158.125 Residue Chemistry continued:
I/ Due dates refer to the number of months following receipt of the Registration Standard by the registrant, unless
otherwise indicated.
2/ Fenitrothion is not federally registered for use on food or feed commodities in the United States. Data required
under §158.125 are required to support the tolerance for wheat gluten imported into this country.
3/ Residues of fenitrothion are not expected to enter the diet of food animals because there are no domestic food
uses. If future federal registrations for fenitrothion on plant commodities used for animal feeds, or regulations
covering the importation of animal products from countries in which fenitrothion is registered for use become
established, additional animal metabolism studies may be required.
4/ Residues of p-nitrocresol in or on samples of wheat gluten must be subjected to analysis by multi-residue
protocols. Protocols I-IV are available from the National Technical Information Service in Springfield, VA
under Order No. PB 203734/AS. Additional methods, validation data, and residue data may be required in the
future if the Agency finds that additional metabolites/degradation products found in plants (grain) constitute
residues of toxicological concern.
5/ Storage conditions and intervals must be reported for the samples used to generate the residue data submitted
in support of the established tolerance for fenitrothion residues in wheat gluten imported into the U.S. from
Australia. Data must also be provided which depict the decline in residues during the storage
under the conditions reported. All residue data must be accompanied by information specifying
intervals and
the storage
intervals and conditions for samples analyzed. Data must also be submitted depicting the storage stability of
residues of concern in appropriate sample substrates under the storage conditions and time intervals specified.
Metabolites other than those covered in the tolerance definition for wheat gluten were fbund to be significant
components of the terminal residue. If these residues are later determined to be of toxicological concern, then
storage stability data for these compounds will also be required. j
6/ Data depicting residues of fenitrothion, fenitrooxon, and p-nitrocresol in or on wheat grain held in storage in
commercial grain silos for 90 days following application at the time of conveyor belt delivery of the 50% EC at
13.2 mg ai/kg of grain are required. Tests must be conducted in a variety of locations under different conditions
_ (including different storage temperatures and humidity) representative of all storage situations encountered in
Australia. Data depicting whether residues of fenitrothion, fenitrooxon, and p-nitrocresol concentrate in bran,
JJ flour, middlings, shorts, and gluten processed from wheat grain bearing measurable weathered residues.are required.
_^ Data requirements for bran, flour, middlings, and shorts will be waived if it can be demonstrated that these milled
products will not be included in food items or become feed for animals from which foods are obtained and exported
from Australia to the United States.
7/ A progress report is due 8 months from receipt of this Standard. Semi-annual reports are due thereafter.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITRDTHION
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI
Photodegrada t ion
161-2 - In Water TGAI
161-3 - On Soil TGAI
161-4 - In Air TGAI
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI
Test Use
Substance Patterns
or PAIRA B,F,G,H
or PAIRA B,G
or PAIRA G
or PAIRA F
or PAIRA B,F,G,H
Does EPA
Have Data?
No
No
No
No
No
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission*,
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 27 Months 2/
162-2 - Anaerobic Soil TGAI or PAIRA N/A
162-3 - Anaerobic Aquatic TGAI or PAIRA G
162-4 - Aerobic Aquatic TGAI or PAIRA N/A
MOBILITY STUDIES;
163-1 - Leaching and Adsorption/ TGAI B,F,G,H
Desorption or PAIRA
No
Yes
(8 Months - Progress
Report)
27 Months^/
(8 Months - Progress
Report)
Partially 00126947
Yes3/
12 Months
UT
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHICN
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission*/
§158.130 Environmental Fate (continued)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD!
164-1 - Soil
' 164-2 - Aquatic (Sediment)
164-3 - Forestry
58164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
LH
Lr' 165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
TEP
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI
or PAIRA
F
F •
B,H
N/A
G
N/A
B,H
N/A
N/A
N/A
B,G
No
No
No
No
No
Yes 12 Months
Reserved^/
Yes
Yes
27 Months2/
(8 Months - Progress
Report)
27 Months2/
(8 Months - Progress
Report)
Reserved5/
1
No
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission1/
§158^130 Environmental Fate (continued)
TEP G
165-5 - In Aquatic Nontarget
Organisms
EXPOSURE STUDIES:
No
Reserved^/
Indoor Air
Residue Monitoring
Applicators
TEP
TEP
B,F,G,H,I
No
No
YesV 12 Months
(90 Days- Acceptable
Protocol)
Yes ' 6 Months
(90 Days- Acceptable
Protocol)
'!/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ The first progress report is due 8 months after receipt of this Standard. Interim reports are due semi-annually
thereafter.
3/ Acceptable data on characterization of pond sediment used in the study MRID 00126947 are required. In addition,
a study on the mobility of aged fenitrothion in soil is needed.
4/ Reserved pending the results of the laboratory volatility study.
5/ This study is required if soil residues of fenitrothion and/or its major toxic degradate(s) do not reach 50% dissipa-
tion in soil prior to the recommended subsequent application to the same sites utilized in the field dissia
6/ Reserved pending the results of the fish accumulation studies.
7/ An indoor air residue monitoring study to support the use of the 40% WP formulation in human dwellings is
required. The study must be designed to evaluate any decline in air residues over time.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENITROTHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission*/
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inalation Exposure
TEP
TEP
TEP
TEP
B,F
B,F
B,F
B,F
No
No
No
No
Yes
NoV
Yes
Yes
27 Months2/
(90 Days - Acceptable
Protocol)
(8 Months - Progress
Report)
27 Months2/
(90 days - Acceptable
Protocol)
(8 Months - Progress
Report)
27 Months2/
(90 days - Acceptable
Protocol)
(8 Months - Progress
Report)
I/ Due dates refer to the number of months following receipt of the Standard by the registrant, unless otherwise
indicated.
2/ The first progress report is due 8 months after receipt of this Standard. Interim reports are due semi-annually
thereafter.
3/ Not required because chemical is not applied as a soil application.
LH
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITRDTHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission*/
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity -
Rabbit
81-3 - Acute Inhalation Toxicity -
Rat
81-7 - Delayed Neurotoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding - Rodent
and Nonrodent (Dog)
82-2 - 21-Day Dermal - Rabbit
82-4 - 90-Day Inhalation - Rat
82-5 - 90-Day Neurotoxicity
CHRONIC TESTING;
83-1 - Chronic Toxicity - Rodent
and '-Nonrodent
TGAI B,F,G,H,I
TGAI B,F,G,H,I
TGAI B,F,G,H,I
TGAI B,F,G,H,I
TGAI F,H,I
TGAI B,F,G,H,I
TEP F,I
TGAI B,F,G,H,I
Yes
Yes
Yes
Yes
No
No
No
Yes
00061091
00071960
00062977
00069955
00069955
No
No
No
No
Yes2/
Yes
Yes
No
12 Months
9 Months
15 Months
(8 Months - Progress
Report)
TGAI F,I.
Yes
00071965
00143017
No
00
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITRDTHION
Data Requirement
§158.135 Toxicology (continued)
83-2 - Oncogenicity -
-Rat
-Mouse
83-3 - Teratogenicity - Rat
- Rabbit
MUTAGENICITY TESTING:
84-2 - Gene Mutation
Test Use Does EPA Bibliographic Must Additional Timef rame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission1/
TGAI B,F,G,H,I Yes 00071965 No
TGAI B,F,G,H,I No' Yes
(8
TGAI B,F,G,H,I No Yes
-(8
TGAI B,F,G,H,I No Yes4/
(8
TGAI B,F,G,H,I Partially 00163432 Yes5/
jf
50 MonthsV
Months- Progress
Report)
15 Months
Months- Progress
Report )
15 Months
Months- Progress
Report )
12 Months
84-3 - Structural Chromosomal
Aberration
TGAI B,F,G,H,I No
84-4 - Other Genotoxic Effects TGAI B,F,G,H,I No
Yes
Yes
(9U Days- Acceptable
Protocol)
12 Months
(90 Days- Acceptable
Protocol)
12 Months
(90 Days- Acceptable
Protocol)
(Ji
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITRQTHION
Data Requirement
§158.135 Toxicology (continued)
85-1 - General Metabolism
SPECIAL TESTS:
Ocular Effects
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission1/
PAI or
PAIRA
TGAI
B,F,G,H,I
B,F,G,H,I
No
No
Yes 24 Months^
(8 Months - Progress
Report)
YesV 9 Months
(90 Days- Acceptable
Protocol)
i/
V
V
Due dates refer to the number of months following receipt of the Registration Standard by the registrant, unless
otherwise indicated.
A subchronic rodent study to determine the NOEL for plasma cholinesterase is required. An acceptable 2-year chronic
feeding dog study is available and supersedes the need for a subchronic dog study.
The first progress report is due 8 months after receipt of this Standard. Interim reports are due semi-annually
thereafter.
The rabbit teratology study submitted by Sumitomo in 1986 is considered to be invalid because semen from more than
one strain of rabbit was used to artificially inseminate does. Due to possible genetic differences in the strains
of rabbits used, it is impossible to determine whether fetal effects were due to the treatment or parental genetics.
A point mutation assay in mammalian cells is required.
An acute toxicity test in the rat is required in which cholinesterase activity (blood) and retinal activity
(electroretinography) are measured. For the acute test, the Agency recornnends a study design which includes
acute sublethal doses, tests performed pretest, at 4 days, and repeated at intervals until full recovery. Measure-
ments must include cholinesterase activity (blood) and retinal electrical activity (eletroretinography). For the
subchronic rat study (which should be combined with other subchronic oral requirements), the Agency recommends
a study design which includes 3 orally treated groups and 1 control group. Observations should be made
pre-test and at intervals for at least 90 days; the doses should be based on the results of the acute study and
previously submitted chronic study. Measurements must include cholinesterase activity (blood), retinal electrical
activity (electroretinography), ophthalmoscopic observations, fundus observations/photographs, clinical
observations of potential cholinergic signs, body weights, and histopathology of the eye (light and EM, including
intra- and extraocular muscle, optic nerve and retina). An acceptable protocol must be submitted within 90 days of
receipt of this Standard.
CN
O
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHICN
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted?
Submission-1
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING;
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
- Upland Game Bird
- Waterfowl
TGAI B,F,G,H Yes
TGAI B,F,G,H Yes
TGAI
B,F,G,H Yes
00160000
00126885
00126886
00022923
00022923
No
No
No
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
Upland Game Bird
and Waterfowl
71-5 - Simulated Field Testing and TEP
Actual Field Testing -
Mammals and Birds
N/A
G
Partially 00159565
Partially
00126929
00126919
00126920
00093939
40243801
24 MonthsV
(90 Days-Acceptable
Protocol )
YesV 48 MonthsV
(terrestrial field
study)
(90 Days-Acceptable
Protocol )
24 Months4/
(screening study)
(90 Days-Acceptable
Protocol )
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Data
§158
72-1
ON
Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
.145 Wildlife and Aquatic Organisms (continued)
- Freshwater Fish Toxicity
- Coldwater Fish Species
- Warmwater Fish Species
TGAI B,F,G,H Yes
TEP G Yes
TGAI B,F,G,H Yes
TEP G Yes
40094602
00125909
00120401
40094602
00125909
00120401
40094602
40094602
00128048
No
No
No
No
Timeframe
for
Submission^/
AQUATIC ORGANISM TESTING:
72-2
- Acute Toxicity
to Freshwater
Invertebrates
TGAI B,F,G,H Yes
40094602
00125909
00120401
No
- Unique Formulation
TEP
No
Yes
9 Months
72-3 - Acute Toxicity to TGAI
Estuarine and Marine
Organisms
72-4 - Fish Early Life Stage, TGAI
and
- Aquatic Invertebrate
Life Cycle
Partially 40228401
No
No5/
Yes6/
15 Months
(8 Months- Progress
Report)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timer rame
for
Submission
§158.145 Wildlife and Aquatic Organisms (continued)
72-5 - Fish - Life Cycle TGAI G
72-6 - Aquatic Organism
Accumulation
TGAI,PAI or G
Degradation Product
72-7 - Simulated Field Testing
and Actual Field Testing
- Aquatic Organisms
ON
TEP
No
No
Partially
0093942
0126915
0093940
U126916
0126958
0126956
Reserved7/
Reserved^/
Yes8/
48 MonthsV
(aquatic field study)
(90 Days-Acceptable
Protocol)
24 MonthsV
(screening study)
(90 Days-Acceptable
Protocol)
y
Due dates refer to the number of months following receipt of this Registration Standard by the registrant/ unless
otherwise indicated.
Required for forest uses which allow repeat applications. The submitted studies (0159665,0015966) did not specify
the percent active ingredient of the test material.
The hazard assessment for the forest uses indicate a risk to birds. A comprehensive terrestrial field study is
needed to quantify effects on avian populations for the spruce budworm use to determine if the hazard
indicated by
available field evidence is ecologically significant. A screening terrestrial field study is needed for the pine
bark beetle uses to determine if the hazard indicated by the available laboratory and exposure information will
result in significant adverse effects to birds or other vertebrates (e.g. reptiles and amphibians). Acceptable
protocols are due 90 days from receipt of this Standard. A document is available from the Agency which outlines
an acceptable approach to these studies.
A progress report is due 8 months from receipt of this Standard. Semi-annual reports are due thereafter.
The submitted data do not fulfill guideline requirements; but the forestry uses of fenitrothion do not require
marine/estuarine testing.
Data reviewed under this Standard indicate a need for chronic data for both freshwater fish and aquatic invertebrate;
e.g. the Estimated Environmental Concentration (EEC) exceeds 0.01 of the ££50*3 for both fish and aquatic inverte-
brates.
Reserved pending receipt of lower tier tests and environmental fate studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.145 Wildlife and Aquatic Organisms (continued)
8/ Hazard assessment of the forest uses (spruce budworm and pine bark beetle) indicates a risk to aquatic organisms.
A comprehensive aquatic field study to quantify effects on aquatic organisms is needed for the spruce budworm
uses to determine if the hazard indicated by available field evidence is ecologically significant. A screening
field study to qualify exposure and mortality to aquatic organisms is needed for the pine bark beetle uses to
determine if the hazard indicated by available laboratory and exposure information will result in significant
adverse effects to aquatic organisms.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITROTHION
Data Requirement Test Use Does EPA
Substance Patterns Have Data?
§158.155 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS:
141-1 - Honey Bee Acute Contact TGAI B,H Yes
LDsn
Bibliographic
Citation
00036935
05001991
Must Additional
Data be
Submitted?
No
Timeframe
for
Submission V
x
141-2 - Honey Bee - Toxicity of
Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for
Pollinators
TEP B,H
Reserved^/
TEP B,H
NONTARGET INSECT TESTING - AQUATIC INSECTS:
Yes
00126931
No
No
No3/
142-1 - Acute Toxicity to ReservedV
Aquatic Insects
142-2 - Aquatic Insect ReservedV
Life Cycle Study
142-3 - Simulated or Actual Field ReservedV
Testing for Aquatic
Insects
143-1 - NONTARGET INSECT TESTING- ReservedV
thru PREDATORS AND PARASITES
143-3
I/ Due dates.refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ Reserved pending development of test methodology.
3/
This requirement is imposed on a case-by-case basis. Data reviewed under this Standard do not indicate a need for
a field study.
4/ Reserved pending Agency decision as to whether data requirement should be established.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENITFOTHICN
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission I/
121-1 Target Area
Phytotoxicity
TIER I
TEP
No
No2/
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
Seed Germination/
Seedling Emergency
Vegetative Vigor
Aquatic Plant Growth
TIER II
Seed Germination/
Seedling Emergency
Vegetative Vigor
Aquatic Plant Growth
TIER III
Terrestrial Field
Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
G
G
G
G
G
G
G
G
No
No
No
No
No .
No
No
No
Yes
Yes
Yes
i
ReservedV
ReservedV
ReservedV
ReservedV
ReservedV
9 Months
9 Months
9 Months
I/ Due dates refer to the number f months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ Data are only required for Special Review and certain other public health situations,
3/ Reserved pending the results of lower tier tests.
O\
O\
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENITROTHION
Data Requirement
Test2/ Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?j/ Citation V Data be for
Submitted? SubmissionV
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP All
Disclosure of
Ingredients
61-2 - Description of Beginning MP All
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP All
of Impurities
Analysis and Certification of Product
Ingredients;
Yes
Yes
Yes
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3- Analytical Methods to Verify
Certified Limit
Physical And Chemical Characteristics:
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9 Months
9 Months
O\
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENITROTHION
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance^/ Patterns Have Data?2/ Citation ±/ Data be for
Submitted? SubmissionV
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-7
63-12
63-14
63-15
63-16
63-17
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
15 Months
(8 Months - Progress
Report)
63-18
63-19
63-20
Other
64-1 -
O\
CD
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements :
- Submit tal of
Samples
*
MP
MP
MP
MP
All
All
All
All
Yes
Yes
Yes
Reserved^/
9 Months
9 Months
9 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENITROTHION
Data Requirement
rest
Substance^-/
use
Patterns
Dees
Have
EPA
Data£/
Bibliographic
Citation^/
Must Additional
Data be
Submitted?
Timeframe
for
Submission^/
§158.120 Product Chemistry (continued)
I/ Formulation intermediates are also included in the category of manufacturing-use products.
2/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each manufacturing-use product. New requirements have been introduced and previously submitted
data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
4/ If samples are needed, the Agency will request them.
ON
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENITROTHION
Data
Requirement Test*/ Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Timeframe
Data be for
Submitted? Submission2/
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP All
- Acute Dermal Toxicity MP All
- Rabbit
- Acute Inhalation Toxicity MP All
- Rat
- Primary Eye Irritation MP All
- Rabbit
- Primary Dermal Irritation MP All
- Rabbit
- Dermal Sensitization MP All
- Guinea Pig
Partially 00061091
Partially 00071960
Partially 00062977
Partially 00062976
Partially 00062976
Partially 00061091
YesV
YesV
YesV
Yes2/ '
YesV
YesV
9 Months „
9 Months
9 Months
9 Months
9 Months
9 Months
I/ Formulation intermediates are also included in the category of manufacturing-use products.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Data will support technical grade formulations (97% and above). Data must be submitted to support all other
formulations.
-------
\
' 1
i
APPENDIX IV
BIBLIOGRAPHY APPENDICES
71
-------
\ BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
72
-------
BIBGUIDE-2
a. Author. Whenever t^he Agency could confidently identify
one/ the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort/ the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the .-
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the.
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
73
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenitrothion Standard
MRID CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00061091 Miyamoto, J.; Kadota, T. (1972) Toxicological Studies with Sumith-
ion. (Unpublished study received on unknown date under unknown
admin, no.; submitted by Sumitomo Chemical Co., Ltd., Baltimore,
Md.; CDL:127719-B)
00062928 Patchett, G.G. (1976) Determination of Residues of Sumithion and
Sumioxon in Crops and Soil. Method no. RRC 76-50 dated Nov 23,
1976. (Unpublished study received Dec 8, 1980 under 476-EX-100;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:
243935-E)
00062976 Saunders, D.R. (1978) Toxicity Evaluation: Sumithion 8E: Toxi-
cology Laboratory Report: T-6290. (Unpublished study received
Dec 8, 1980 under 476-EX-100; submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL:243934-A)
00062977 Leong, B.K.J. (1978) Acute Inhalation Toxicity Study in Rats:
IRDC No. 153-080. (Unpublished study received Dec 8, 1980 under
476-EX-100; prepared by International Research and Development
Corp., submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:243934-B)
00069955 Miyamoto, J.; Kadota, T.; Kagoshima, M. (1976) Acute Oral Toxicity
and Delayed Neurotoxicity of Sumithion in Hens. Rev. (Unpub-
lished study, including letter dated Aug 26, 1976 from N. I to to
J. Miyamoto, received Feb 28, 1978 under 476-EX-80; prepared by
Sumitomo Chemical Co., Ltd., Japan, submitted by Stauffer Chem-
ical Co., Richmond, Calif.; CDL:096826-D)
00069962 Hosokawa, S.; Miyamoto, J. (1974) Metabolism of 14C-labelled
Sumithion, 0,0-dimethyl 0-(3-methyl-4-nitrophenyl) phos-
phorothioate in apples. Botyu-Kagaku 39(II):49-53. (Also in
unpublished submission received Feb 28, 1978 under 476-EX-80;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:
096826-L)
74
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fem'trothion Standard
MRID CITATION
00120401 Woodward, D.; Mauck, W. (1980) Toxicity of five forest insecticides
to cutthroat trout and two species of aquatic invertebrates.
Bull. Environm. Contain. Toxicol. 25:846-854. (Submitter 69597;
also in unpublished submission received Dec 9, 1982 under 3125-
327; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
248989-0)
00125909 Schoettger, R.; Mauck, W. (1976) Toxicity of Experimental Forest
Insecticides to Fish and Aquatic Invertebrates: Submitter
63089. (Unpublished study received Jun 26, 1978 under 3125-EX-
150; prepared by U.S. Fish & Wildlife Service, Fish-Pesticide
Research Laboratory, submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:234509-T)
00126885 Fletcher, D. (1971) Report to ...: Acute Oral Toxicity Study with
Sumithion in Ringneck Pheasants: IBT No. J9993. (Unpublished
study received Mar 15, 1973 under 10308-2; prepared by Industri-
al Bio-Test Laboratories, Inc., submitted by Sumitomo Chemical
Co., Ltd., Baltimore, MD; CDL:004891-B)
00126886 Fletcher, D. (1971) Report to ...: Acute Oral Toxicity Study with
Sumithion Technical in Mallard Ducks: IBT No. J9992. (Unpub-
lished study received Mar 15, 1973 under 10308-2; prepared by
Industrial Bio-Test Laboratoeies, Inc., submitted by Sumitomo
Chemical Co., Ltd., Baltimore, MD; CDL:004891-C)
00126915 Vincent, F. (1969) Observations of the Effects of Sumithion on
Aquatic Farms: Spruce Budworm Control Project, Maine. (Unpub-
lished study received Mar 15, 1973 under 10308-2; submitted by
Sumitomo Chemical Co., Ltd., Baltimore, MD; CDL:004892-T)
00126916 Dimond, J.; Malcolm, S. (1970) Accothion and Aquatic Insects: Moni-
toring of Stream Populations. (Unpublished study received Mar
15, 1973 under 10308-2; prepared by Univ. of Maine, Dept. of En-
tomology, submitted by Sumitomo Chemical Co., Ltd., Baltimore,
MD; CDL:004892-U)
00126919 Peterson, J. (1969) The Effects of Sumithion on Birds. (Unpub-
lished study received Mar 15, 1973 under 10308-2; prepared by
U.S. Fish and Wildlife Service, submitted by Sumitomo Chemical
Co., Ltd., Baltimore, MD; CDL:004982-Y)
00126920 Peterson, J. (1970) The Effects of Accothion on Birds and Other
Fauna. (Unpublished study received Mar 15, 1973 under 10308-2";
prepared by U.S. Fish and Wildlife Service, submitted by Sumito-
mo Chemical Co., Ltd., Baltimore, MD; CDL-.004892-Z)
? 76
-------
\ . OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHJY
Citations Considered to be Part of the Data Ba;se Supporting
Registrations Under the Fenitrothion Standard
MRID_ CITATION
00126929 Fink, R.; Grimes, J. (1978) Simulated Field Study in Alfalfa with
Bobwhite Quail, Mallard Ducks, and Rabbit Utilizing Sumithion 8E
Wildlife International Ltd. Identification No. WI-546. Final
rept. (Unpublished study received Feb 6, 1979 under 476-EX-80;
prepared by Wildlife International Ltd., submitted by Stauffer
Chemical Co., Richmond, CA; CDL:097792-A)
00126931 Johansen, C.; Atkins, E. (1978) Bee Toxicology: Sumithion SEC:
TEst No. I-59-P-78. (Unpublished study received Feb 6, 1979
under 476-EX-80; prepared by Washington State Univ., Dept. of
Entomology and Univ. of California—Riverside, Dept. of Entomol-
ogy, submitted by Stauffer Chemical Co., Richmond, CA; CDL:
097792-C)
00126947 Spillner, C., Neuberger, A. (1977) Sumithion Adsorption and Desorp-
tion in Various Soils: Project 149046. (Unpublished study re-
ceived Aug 17, 1977 under 39398-3; submitted by Sumitomo Chemi-
cal America, Inc., New York, NY; CDL:231306-L)
00126956 Peterson, R.; Zitko, V. (1973) Variations in Stream Insect Drift
Associated with Operational and Experimental Contamination with
Fenitrothion in New Brunswick: Technical Report No. 439. (Un-
published study received Aug 17, 1977 under 39398-3; prepared by
Canada, Fisheries Research Board, Biological Station, submitted
by Sumitomo Chemical America, Inc., New York, NY; CDL:231306-U)
00126958 Rabeni, C.; Gibbs, K. (1976) The Effects of Sumithion on Non Target
Stream Insects in Maine, 1975: Miscellaneous Report 176. (Un-
published study received Aug 17, 1977 under 39398-3; prepared by
Univ. of Maine, Life Sciences and Agriculture Experiment Sta-
tion, Dept. of Entomology, submitted by Sumitomo Chemical Ameri-
ca, Inc. New York, NY; CDL:231306-W)
00128048 McCann, J. (1970) Accothion 8 EC: Bluegill: Test No. 306. (Un-
published study received Nov 7, 1970 under 241-EX-50; prepared
by Pesticides Regulation Div., Animal Biology Laboratory,
submitted by U.S. Environment Protection Agency, Beltsville,
MD; CDL:129845-A)
00135034 Stauffer Chemical Co. (1976) The Results of Tests on the Amount
and Nature of the Residue, and Analytical Methodology Using
Sumithion. (Compilation; unpublished study received Dec 1,
1976 under 476-EX-80; CDL:096472-A)
00143017 Griggs, L.; Jefferson, N.; Blair, M.; et al. (1984) One Year Diet-
ary Toxicity Study in Dogs: Amendment to the Final Report: 491-
011. Unpublished study prepared by International Research and
Development Corp. 320 p.
-------
' OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fenitrothion Standard
MRID CITATION
00150219 Taylor, R. (1980) Frozen Stability Studies on Sumithion, Sumioxion,
Aminosumithion, and 3-methyl-4-nitrophenol in Tissues and Milk:
T-10416. Unpublished study prepared by Harris Labs, Inc.
190 p.
00150220 Mihara, Y.; Okuno, Y.; Mikami, Y.; et al. (1979) Supplementary
Metabolism Study of Fenitrothion in Female Goat: Final Report:
HT-70-0101-3. Unpublished study prepared by Sumitomo Chemical
Co., Ltd. 16 p.
00150223 Taylor, R. (1980) Frozen Stability Studies on Sumithion Sumioxon
and 3-Methyl-4-nitrophenol in Poultry Tissue and Eggs: Projects
Nos. T-1149 & T-1150. Unpublished study prepared by Harris
Labs., Inc. 135 p.
00150224 McKay, J. (1981) Letter sent to E.R. Butts dated Jan 28, 1981:
Analytical data from Sumithion stored grain study: Project
No. 149046. 9 p.
00159565 Beavers, J. (1979) One-generation Reproduction Study - Mallard
Duck: Sumithion Technical: Final Report: Project No. 144-112.
Unpublished study prepared by Wildlife International Ltd. 31 p.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US Fish and Wildlife
Service: Resource Publication 153. 91 p.
00163432 Suzuki, H.; Miyamoto, J. (1983) Mutagenicity Tests of Sumithion
with Nitro Reductase-defective Bacteria: HT-30-0259. Unpublish-
ed study prepared by Sumitomo Chemical Co., Ltd. 13 p.
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated
pesticides to worker honey bees (Apis niellifera). Plant
Pathology 27(1):38-40.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40228401 Mayer, F. (1986) Acute Toxicity Handbook of Chemicals to Estuarine
Organisms: EPA/600/X-86/231. Prepared by US EPA Environmental
Research Laboratory, Gulf Breeze, Fl. 275 p.
40243801 Pearce, P.; Peakal 1, D. Erskine, A. (1976) Impact on forest birds of
the 1975 spruce budworm spray operation in New Brunswick. Canadian
Wildlife Service Progress Notes No. 62, March, 1976. 7 p.
78
-------
APPENDIX V
FORMS APPENDICES
79
-------
OMB Approval No. 2000-0468 (Expires 12-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
£PA REGISTRATION NO.
PRODUCT NAME
APPLICANTS 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 refwenced
Guidance Document, I am responding in the following manner:
D1. 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, OECO
Chemicals Testing Programme, I enclose the protocols that I will use:
Attach separate page with a list of the data requirements your company
agrees to satisfy.
D 2. 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
Attach list of data requirements
D 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:
I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D S. I request voluntary cancellation of the leaiuiaUmi of this product (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8S80-K10-82I
80
-------
OMB Approval No. 20004468 (Expires: 12-31-831
(To qualify, 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
items or data:
3. My firm has ottered 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
to the following firm(s) on the following date(i):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 858O-6 (1O-82)
81
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting jpoint
Boiling point
Density, bulk-
density/ or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
82
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81--3
81--4
81--5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flaromability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity^ rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
83
-------
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 requirement for submission of "generic"'data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental 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 in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 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 .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: *
(Typed)
84
EPA Form 8570-27
-------
APPENDIX II
LABELING APPENDICES
85
-------
,, SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panelr preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 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 it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients..
The preferred location is immediately below the product name.'
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
T 86
-------
\ SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY .STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table..below shows the minimum type
size requirements for var-ious size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the.
label, in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item. 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
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.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back • ..
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h ) (2)].
87
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. SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals/ precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h) (2 ) (i ) ]
Item 8B. ENVIRONMENTAL.HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2) (ii ) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on.the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED 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 may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-------
\ , SUMMARY-4
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)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section. • ..
89
-------
> SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and 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,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted i.n connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
90
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
.5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Sigpal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
\
PREFERRED
Center front
panel
Bottom 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
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer,' must
be qualified by "Packed for . . ., "
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
1
i
All front panel precautionary statements
must be grouped together, preferably
blocked. ;
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precau t ionary
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 toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
.
••
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
.aDOMESnCANMALS
CAUTION
ENVKONMENTAL HAZARDS
PHYSICAL OR CHEMCAL
HAZARDS
D«ECTK>N8 FOR USE
I b • MoMM 4 FtdMl to* to
Mt product to •
•Mtthtwhig.
RE-ENTRY STATEMENT
VO
CROP:
CROP:.
.CROP:
PRODUCT
NAME
ACTIVE NOREDCNT: ,
MERT MQREDENT8:,
TOTAL;
100.00%
THIS PRODUCT CONTAMS IBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
CAUTION
STATEMENT OF PRACTICAL TREATMENT
F SWALLOWED:
F M EYES
SEE 8DE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFOBY===
TOWN. STATE
ESTABUSHMENTNO.:
EPAREOISTRATlONNa:
NET CONTENTS:
CROP:
STORAGE AND
DISPOSAL
CNSPOSAL:
WARRANTY STATEMENT
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
It OOME8TB ANMAL8)
CANOE*
ENVIRONMENTAL HAZARDS
PHYSICAL OR CHEMICAL
HAZARDS
DIRECTIONS FOR USE
I k • «toMen ef F««nl hv to UM
Ms preduol to • mm* tneomUKnl
RE-ENTRY STATEMENT
fl Aoofcrttot
|M r^ffffM^Hr^y
cn
STORAGE AND
' DISPOSAL
STORAGE:
CROP:
RESTRICTED USE
PESTICIDE ,
(reason for classIfylnp)
ICK BglAIL flVuJB TO AND IBE ONLT BY CBntnCD APPUCKIOS OR
rsssac igffla? 1HSIR Diaacr surenvmoH AND ONLY rcR nose
UJB3 COVERED BY THE CEHTiriBD APPUCAIDR'S CERTIPICATICT4
PRODUCT
NAME
ACTIVE NQREDCNT:
MERT MOREOIENTS:,
TOTAL:
%
tt
100.00%
THIS PRODUCT CONTAMS LBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
STATEMENT OF PRACTCAL TREATMENT
v SWALLOWED:
FMHALED=
f M EYES
SEE SCC PANEL FOR ADOmONAL PRECAUTIONARY STATEMENTS
MFO BY
TOWN. STATE ==
ESTABLISHMENT NO.
EPA REGISTRATION NO.
NET CONTENTS:
WARRANTY STATEMENT
-------
Chapter I—environmental Protection Agency
§ 102.10
data
except
(1)
mltted
t obtained the data from anothi
(Identify): applicant copied
a publication: applicant obi
y of the data from EPA). / of
The applicant shall submit
lication a statement that
evaluation of the propertl
and safety of the form
product, may not consider any
supporting the appi
e following data:
data the applicant
(2)
safety of
enta,
end-usei
(3)
regulations.
, EPA under;
data
?e product's
, than to the
:and
[tolerances.
sub-
ph (b) of
to the
ingredl-
xety of the
ixemptio:
;ed um
Cosme
Pood. Drug.
(e) If the ap
item of data hi
section was
pense of) anoth
ly submitted the
predecessor. USD,
ary 1. 1970. to sui
for registration,
permit, or
use to an
reregistration (
and the origina/ data
reached wit
amount
any com;
ood additive
and other
the Federal
Act.
that any
ted under this
y (or at the ex-
who original-
to EPA (or its
on or after Janu-
an application
tal use
t adding a new
itration. or for
the applicant
Emitter have
ent on the
terms \t payment of
that \rnay be pay-
section
able
3(cxiXDXii)/wlth regardXto approval
of the application), the applicant shall
submit to EPA a statement that he
has furnlsMed to each SUC)A identified
original daca submitter
(DA notification of the applicant's
Intent to Apply for registration, includ-
ing the yropoeed product
(2) Aa offer to pay the
penaation. with regard to the
of the/ application, to the
by FIFRA sections 3(c)
CX2XO):.
An identification of the it
to which the offer applies:
(4) An offer to commence nego4
to ascertain the amount
of compensation to be paid:
f(5) The applicant's name,
I telephone number.
If the applicant's product con
any active Ingredient other
that are present solely
incorporation into the
formulation, of one or/more
pesticide
from another
pplicant shall
as to
application
vledgment
, section 3i
lucer,
comply
ingre-
con-
for pur-
X1XD) the
other
purcl
then the1
with i 16
dlent, and
tain an
poses of
application re!
ing registratii
if it were based
consideration of)
Q> xil data
dted by the applii
the registration:
(2) Each other
Agency's files w!
(1) Concerns the
of any such active
(U) Is one of the types
EPA would require to be
scientific renew by EPA
cant sougm the Initial
under FIFRA Section 3(c)A) of a
product j«nth composition andMntend-
ed uses/dentical to those proposed for
the applicant's product, undeX the
data /equlrements In effect on\ the
date/EPA approves the applicant's
present application.
-------
5 162.10
tlv) The product registration
number as prescribed In paragraph (e)
of thh section;
<») The producing establishment
number as prescribed In paragraph (I)
of this section;
tvl) An Ingredient statement as pre-
scribed in paragraph »g) of this sec-
tion;
The use classification^) 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
consplcuoiisness (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-polnt 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 mls-
brandlng provisions of the Act. "se-
curely 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
TIM* 40—Protection of Environment
wiapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such ouMde wrapper or con-
tainer. If It Is a part of the package as
customarily distributed or sold.
(II) Tan* can and other bulk con-
tainer*— Transportation. While a
pesticide product Is In transit, the ap-
propriate provisions of 49 CFR Parts
170-1«9. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
» rylng them, define the bask Federal
requirements. In addition, when any
registered pesticide product Is trans-
ported In a tank car. tank truck or
other mobile or portable bulk contain
er. a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
remain In the custody of the user, a
copy of the label of labeling. Including
all appropriate directions for use. shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
(5) Fal»e or misleading statements.
Pursuant to section 2(qMlMA) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1162.15. to mlsbranded If Its labeling to
false or misleading In any particular
Including both pestlcldal and non-pes-
tlcldal claims. Examples of statements
or representations In the labeling
which constitute mlsbrandlng Include:
(DA false or misleading statement
concerning the composition of the
product;
(II) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device; •., . i
(Iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device Is recommended or endorsed by
Chapter I—Environmental Protection Agency
§ 1*2.10
any agency of the Federal Govern-
ment;
(vl) The name of a pesticide which
contains two or more principal active
Ingredients If the name suggests one
or more but not all such principal
active Ingredients even though the
names of the other Ingredients are
stated elsewhere In the labeling;
(vll) A true statement used In such a
way as to give a false or misleading Im-
pression to the purchaser;
(vlll) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(Ix) Claims as to the safety of the
pesticide or Its Ingredients. Including
statements such as "safe," "nonpolson-
ous." "nonlnjurloiis." "harmless" or
"nontoxlc to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural Ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling. (I) Except
as provided In paragraph (aXflMll) of
this section, final printed labeling
thu.it be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product to sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 1162.8(bX4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant Is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label. It must
be qualified by appropriate wording
such as "Packed for * • V "Distribut-
ed by * • •." or "Sold by to show
that the name to not that of the pro-
ducer. .- -
(d) Net weight or measure of con-
lenls. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide Is a liquid, the ;
net content statement shall be In '
terms of liquid measure at 68" F (20"C)
and shall be expressed In conventional ~
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide Is solid or semlso-
lld. viscous or pressurized, or Is a mix-
ture of liquid and solid, the net con-
tent statement shall be In terms of
weight expressed as avoirdupois •.
pounds and ounces.
(4) In all cases, net content shall be
stated In terms of the largest suitable ;
units. I.e., "1 pound 10 ounces" rather
than "26 ounces."
(B) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(6) Variation above minimum con-
tent or around an average to permissi-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
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-
-------
CO
91*1.10
allel to It The registration number
and the required Identifying phrwe
shall not appear hi such a manner as
to suggest or Imply recommendation
or endorsement of-the product by the
Agency.
it) Producing ettabUthmentt 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 hi 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.
-------
§ 161.10
cat treatment b some reference such
as "See statement of practical treat-
ment on back panel" appear* on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categoric*. The
statement of practical treatment la not
required on the front panel except aa
described in paragraph (hHlNlllKA) 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 (hXJ) of Mils
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:
40-TrolMHon of fnvwotHMtif Chopl.r I—f nvlronm.nlai Protection Agency
Stool MM tart I
Afcoo* tOto 19-
AtxxwIStoM-
Ow'30
10
II
(2) Other required warntnpt and pre-
cautionary itatement*. The warnings
and precautionary statements aa 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 human* and domeitic
animal*. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
routeCs) 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.
Oat.
frnwofi (Mil. Do not brwfto
•Ml. Da not 9* k» o^o. en
(Front pflnvf irtatanitnt ol
Idu* or «ny
itt\ oron cM*«
•tar bo M* •
trough •* •*<). Da not I
•prey nMI. Do no) f* ki •»••. OH i
ctatftof. tAppraprMo avt dd olaJwponli
Mil.
**•!. i
I l*m or IDIOT "**l.
contort iriti okki |o|M or eMhkigl.
pridoMoMfMMMrti*oj>VeAI. .
INo proeouftmorf HQIIIIIIIOI n**ooM
9Un MI OyO lOCV
•toon «hon horaMng. HcnnM or Mat • MnNoMd.
or* lond o»ki| ti»»iun Do no) g* ki opo*.
•M ^fct. iv nit ^faffrirM. fr^M^M 0 ••^•fawwf. t Jto
OM^OTMOT cMNhg. ki en* ol
iV «noh oyo» or oM» »«i phmly el
oltanMon V krftrton pwMv.
^^^^_ ^HBA^rfl
mwB ivqpr^o.1
Od miiditol
IHOI
(II) IMvtronmental Jtazantt. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired staling the nature of the
hazard and the appropriate precau-
tions to* avoid potential accident.
Injury or damage. Examples of the
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 LDn 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 I/CM 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 avlan acute oral LOM of 100
mg/kg -or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
§ 162.10
"This pesticide Is extremely tnxlc to
wildlife (fish)" Is required.
(E) For uses Involving foliar applica-
tion to agricultural crops, fores!*, or
shade trees, .or for mosquito abate-
ment treatments, pesticides in*!- !.r.
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." ,
(III) Fhysical or chemical hazards.
Warning statements on the flammnbll-
Ity or explosive characteristics of the
pesticide are required as follows:
f^-'?!^. _____________ r.
***"••*
Rnh poM of or botov XT F: • «MNioeli «•
•nf nltw opOTlng.
FlnnpaM ODOM WFandnotOMrotrForltio
•onw mmlan to mor* »Mn I* ki long M • <«Monc*
ol 8 hi horn •» Itamo.
tuning.
unrtw pr***ur*.
Do nr4 piwinliiMi or .
HTiovw IIW f mwy
Irom
. j 9m. nvf
•pMrfifl, •no optn MMVW. Oo *wjl pimctw O*
EvfXMtv* to lamp«r«lw«* flbow* 130* F
ConMnH uncfar pr« IWF.
(B) NOHracssuntzro COMMMCM
Cirtoum .
•wtaen.
... Fkvnmnbh). K*op ow«» (row two* ond op*n •
. Da not u*o or dor* now html or open Item*
U) Direction* for V*e—(1) General
requirements—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the
averag'e person likely to use or to su-
pervise 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.
(II) Placement of direction* 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 reference 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) Exception* to requirement for
direction for use—(A} Detailed direc-
tions for use may be omitted from la-
beling of pesticides which arc Intended
for use only by manufacturers of prod-
ucts other than pesticide products In
their regular manufacturing processes.
provided that:
-------
§ 162.10
CD
O
(1) The label clearly shows that the
product Is Intended for use only In
'manufacturing processes and specifies
the typets) of products Involved.
(2) Adequate Information such as
technical data sheets or bulletins, to
available to the trade specifying the
type of product Involved and Its
proper use In manufacturing process-
es;
Immediately below the state-
ment of use classification, the state-
ment "It to a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
(Ill) The slte.>
(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.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) (Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who to not phys-
ically present at 3.tos s5i2
Chapter I—Environmental Protection Agoncy
§162.11
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who to physically present.
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Vie Clarification.
By October 22. 1976. all pesticide prod
ticta mail bear on their labels a state-
ment of use classification as described
In paragraphs (JX1) and <2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In Into sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use.
(1) General Ute Classification. Pesti-
cide products bearing directions for
uscKs) classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use, will be
considered a false or misleading state-
ment under the statutory definitions
of mlsnrandlng.
(2) Restricted Ute Classification.
Pesticide products bearing direction
for use(8) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set In type
of the name minimum sizes as required
for human hazard signal words (see
table In 1162.10(hXlXlv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to mak<* It unlikely to
be overlooked under customary condi-
tions of purchase and use. the stale
mcnt "Restricted Use Pesticide." shall
appear.
(B) Directly below this statement on
the front panel, a nummary statement
of the terms of restriction Imposed as
a precondition to rcglsl.ratlnn shall
appear. If use to restricted to certified
applicators, the following statement Is
required: "For retail sale to aiul use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certlflratlnn." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. I Reserved I
140 PR 383*8. July 3. 1975: 40 PR 3332*.
An*. I. 1975; 40 PR 38571. Au«. 31. 1075. m>
amended »l 43 PR 578(1. Frb 0. 10781
fZ.ll Criteria far drlrrmlnntlonx of i
••nimble »d»»n»*
teria for Issuance of Notife of
Intent*, to Deny Registration,
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
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 incinerate
container. Exposure to
temperatures above 130'°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
101
-------
\ . 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 is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
102
-------
\ 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 disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type,Listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse(or equivalent)T Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke. ...
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^-, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording) •
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
103
-------
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 (see list in this Appendix) or are assigned
to Toxicity Category I on the basis of oral or dermal toxicity,
skin or eye irritation potential, or Toxicity Category I or II
on the basis of acute inhalation toxicity must bear the following
pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a violation
of Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
3. The labels of all products, except those intended for domestic
use, containing active or inert ingredients that are Toxic Hazardous
Wastes (see list in this Appendix) or meet any of the criteria-.
in 40 CFR 261, Subpart C for a hazardous waste must bear the
following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according
to label instructions, contact your State Pesticide or Environ-
mental 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 conta-iner
in several layers of newspaper and discard in trash."
104
-------
PEST/DIS-2
P003 107-13-1
P070 116-06-3
P004 309-00-2
POOS 107-18-6
P006 1302-45-0
POOS 504-24-5
P010 7778-39-4
P011 1303-28-2
P012 1327-53-3
P021 . 592-01-8
P022 75-15-0
P024 106-47-8
P030
P031 506-77-4
P037 60-57-1
P039 298-04-4
P040 297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA # and CAS »
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldriri
Allyl alcohol
Aluminum phosphide
4-Amiriopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
0,0-Diethyl S- [2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Di.ethyl 0-pyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
105
-------
PEST/DIS-3
Strychnine and salts P108
0,0,9,0-Tetraethyl P109
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill
Thallium sulfate P115
Thiofanox . , P045
Toxaphene P123
Warfarin (>0.3%) P001
Zinc phosphide (>10%) P122
57-24-9
60-41-3
3689-24-5
107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CFR 261.31]
2-Chloroethy1 2- ( 2,4,6-trichloro-
phenoxy) ethyl ether
Dehydroabietylammonium
pentachlorophenoxide
Erbon
0-ethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(Hexachlorophene)
—Potassium salt of
—Sodium salt of
—Disodium salt of
F027 5324-22-1
F027 35109-57-0
F027 136-25-4
F027 327-98-0
F027 70-30-4
F027 67923-62-0
F027 3247-34-5
F027 5736-15-2
Pentachlorophenol F027
—Potassium salt of F027
—Sodium salt of F027
— Zinc salt of F027
— Zinc salt of N-alkyl F027
(C16~C18)--]- ,3-propanediamine
—Pentachlorophenyl laurate F027
Potassium trichlorophenate (2,4,6) F027
Potassium trichlorophenate (2,4,5) F027
Silvex F027
—2-Butoxyethyl ester F027
—Butoxypolypropoxypropyl ester F027
—Butoxypropyl ester F027
—Diethanolamine salt F027
—Diisopropanolamine salt F027
—Dimethylamine salt F027
—Dipropylene glycol isobutyl F027
ether ester
—Ethanolamine salt F027
—2-Ethylhexyl ester F027
—Isooctyl ester F027
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
106
-------
PEST/DIS-4
— Isopropanolamine salt F027
—Monohydroxylaluminum salt F027
—Polypropoxypropyl ester F027
—Potassium salt F027
—Propylene glycol isobutyl F027
ether ester
—Sodium salt - F027
—Triethanolamine salt F027
—Triethylamine salt F027
—Triisopropanolamine salt F027
—Tripropylene glycol isobutyl F027
ether ester
Sodium 2-(2,4,5-trichlorophenoxy) F027
.ethyl sulfate
Tetrachlorophenols F027
—Alkylamine*amine salt (as in F027
fatty acids of coconut oil)
—Potassium salt F027
—Sodium salt F027
2,4,5-Trichlorophenol F027
2,4,6-Trichlorophenol F027
2,4,5-Trichlorophenol salt of F027
2,6-bis[(dimethylamino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt FU27
2,4,6-Trichlorophenol, sodium salt F027
2,4,5-Trichlorophenoxyacetic acid F027
—Alkyl C-12 amine salt F027
—Alkyl C-13 amine salt F027
—Alkyl C-14 amine salt F027
—N,N-diethylethanolamine salt F027
—Dimethylamine salt F027
—N,N-dimethyllinoleylamine salt F027
—N,N-dimethyloleylamine salt F027
—N-oleyl-l,3-propylene F027
diamine salt
—Sodium salt F027
—Triethanolamine salt F027
—Triethylamine salt F027
—Alkyl (C3H7 - C7H9) ester F027
—Amyl ester F027
--•Butoxyethoxypropyl ester F027
—2-Butoxyethyl ester F027
—Butoxypropyl ester F027
—Butyl ester F027
—Dipropylene glycol isobutyl F027
ether ester
—2-Ethylhexyl ester F027
—Isobutyl ester F027
53404-13-0
69622-82-8
83562-66-7
2818-16-8
53466-84-5
37913-89-6
17369-89-0
53404-74-3
53404-75-4
53535-30-1
3570-61-4
25167-83-3
53535-27-6
25567-55-9
95-95-4
88-06-2
53404-83-4
136-32-3
3784-03-0
93-79-8
53404-84-5
53404-85-6
53535-37-8
53404-86-7
6369-97-7
53404-88-9
53404-89-0
53404-87-8
13560-99-1
3813-14-7
2008-46-0
120-39-8
1928-58-1
2545-59-7
1928-48-9
93-79-8
53535-31-2
1928-47-8
4938-72-1
107
-------
PEST/DIS-5
—Isopropyl ester F027
—Propylene glycol isobutyl F027
ether ester
—Tripropylene glycol isobutyl F027
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027
hydrogen sulfate [2,4,5-TES]
1,4',5'-Trichloro-2'-(2,4,5- F027
trichlorophenoxy)
methanesulfonanilide [Edolan U]
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
108
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)J
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis ( 2-ethylhexyl )phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
(chloroacet aldehyde)
Chlordane/ technical*
Chlorobenzene*
4-Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1 , 3 , 4-metheno-
2H-cyclobuta [c,d]-pentalen-2-one
(Kepone, chlordecone)
1 , 2-Dibromo-3-chloropropane ( DBCP )
Dibutyl phthalate
S-2,3-(Dichloroallyl diisopropyl-
thiocarbamate ) (diallate,Avadex)
o-Dichlorobenzene*
p-Di chlorobenzene*
Dichlorodif luorome thane
(Freon 12®)
3,5-Dichloro-N-(lf l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(DDD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2,4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1 , 3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane )
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzilate)
RCRA #,
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U07U
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS #
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6 • -
510-15-6
*Proposed for deletion by TCLP proposal
109
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene ,
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol Jmethanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*
Resorcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Trichloromonofluoromethane
(Freon 11®)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
no
-------
PEST/DIS-8
2,4, 5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U248 81-81-2
Xylene U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
111
-------
APPENDIX III
USE INDEX APPENDIX
112
-------
EPA Compendium of Acceptable Uses
0, 0-DI METHYL D- (4-NITRO-M-TOLYL.) PHOSPHOROTHIOATE
TABLE OP CONTENTS
Si te Name Page
TERRESTRIAL NONFOOD CROP £
(Ornamental Plants and Forest Trees) £
GREENHOUSE NONFOOD CROP 4
(Ornamental Plants and "Forest Trees) 4
DOMESTIC OUTDOOR 5
(Household) 5
FORESTRY 6
(Ornamental Plants and Forest Trees) 6
INDOOR &
(Animals and Their Man-made Premises) 8
(Household) 8
(Wide Area and General Indoor/Outdoor Treatment) 9
(Commercial and Industrial Uses) 10
Aircraft (Areas other than edible product areas) 10
Azalea £
Birch £
Boxwood £
Buses (Areas other than edible product areas) 10
Coleus £
Commercial, Industrial and Institutional Areas
(Areas other than edible product areas) 10
Crape Myrtle £
Domestic Dwelling (Outdoor) 5
Domestic Dwellings, Indoor 8
Domestic Dwellings, Indoor S
E1 m £
Euonynius • £
F i r £
Fir &
Gardenia £
Green Ash £
Greenhouse Ornamentals 4.
Hackberry £
Hemlock £
Holly £
Iris £
Japanese Andromeda , £
Juniper £
Oak £
Pet Pr ern i ses 8
Pine £
P i ne 3
Pine 7
Poplar £
Privet £
Pyracantha ' ' £
Railroad Cars (Areas other than edible product areas) 1O
Rhododendron £
Roses £
Issued: 7-0£-86 III-1O5901-1 ] ] 3
Provisional Update: 6-18-87
-------
EPfl Cornoend i urn of ftcceotable Uses
0, O-DIttJETHYL 0- <4-NITRO-l"-TOLYL) PHOSPhOROTHIORTE
TflBi-E OP CONTENTS
Site Name Page
Spruce £
Spruce 6
Sweet gum £
Tax us - £
Trailers (ftreas other than edible product areas) 10
Trucks (ftreas other tnan edible oroauct areas) 1C
Tuliptree 2
Vessels
-------
EPA Cornpend turn of Acceptable Uses
C105901 0, 0-DII^ETHYL 0-(4-NITRO-M-TOLYL) PHOSPHOROTHIOflTE*
TYPE PESTICIDE; Insecticide, ftcaricide
FORttULflTIDNS;
Tech (95%)
PI (£5.0£%, SO'/.)
WP (40%)
EC (4 Ib/gal, 8 Ib/gal)
SC/L (93'/.)
GENERAL WARNINGS AND LIMITATIONS; The use of the following formula-
tions is limited to professional applicators: WP (40%), EC <4
Ib/gal, 8 lb/ gal), SC/L (93%). When mixing, loading, spraying or
cleaning equipment used to apply fenitrothion, wear chemical resis-
tant gloves, protective suits or coveralls that cover the arms,
lens, and torso, and chemical resistant shoes, boots, or shoe cov-
ers. Aircraft operators: Pilots can wear long-sleeved shirt and
long pants but must have a clean pair of chemical resistant gloves
available for exiting the aircraft.
BEE; CAUTION; Fenitrothion is highly toxic to bees exposed to di-
rect treatment or residues on blooming crops or weeds. Do not ap-
ply fenitrothion or allow it to drift to blooming crops or weeds if
be€?s are visiting the treatment area.
Agricultural Crop Tolerances (other than those listed in the text):
Wheat, gluten (postharvest in Australia) 15 pprn
*Fenitrothion
Surnithion
Issued: 7-02-86 111-105901-1 j | 5
Provisional Update: 6-18-87
-------
EPA Compendium of Accent able Uses
0,0-D1METHYL 0-(4-NITRO-fl-TQLYL5 PHCSPHOROTHIOflTE
Site ana_Pest Dosages and Tolerance. Use, Limitations
Formu.l.at ion (s)
TERRESTRIAL. NONFOOD CROP
(0 r n a rn e n•cal Plants and Forest Trees)
/SAOiici^A Azalea
/3502SAA Birch
/34031AS Boxwood
/31071-A Coleus
/34046AA Crape Myrtle
/35049AA Elm
/34053AA Euonymus
/35051AA Fi.r
/34063AA Gardenia
/35065-.fi Green Ash
/35067RP Hackberry
/35068AA Hemlock
/34070SA Holly
/311£6SA Iris
/34078AA Japanese flndromeda
/35073AR Juniper
/35093fifi Oak
/35098fta Pine
/35101Aft Poplar
/34088flci Privet
/34058PO Pyracantha
/34118flfi Rhododendron
/341£0ftft Roses
/35116AP Spruce
/35118PR Sweetgum
/35130ftfl Tax us
/35120AR Tuliptree
/35128AA Willow
/32000CR
IQAXARA ftndrorneda lace
bug
ITAPftGA flzalea leaf-
miner
IOAHAKA Balsam gall
midge
ISBEAMA Birch leafminer
INASCSA Black vine wee-
vil
IRAXAFft Blistergall
psy1 lid
(Hackberry
psyllid)
Reentry into treated areas is
orohibitec for £4 hours after the
end of the application, unless
the protective clothing is worn.
When mixing, loading, spraying or
cleaning equipment, or during
early reentry into treated areas,
wear chemical resistant gloves,
protective suits or coveralls
that cover the arms, legs, and
torso, anc chemical resistant
shoes, boots, or shoe covers.
0.5-1 lb/100 Foliar application. Apply as a
gal broadcast or spot spray to the
(8 Ib/gal EC) point of runoff. Repeat at 7 day
intervals as heeded.
Issued: 7-02-86
111-105901-2
116
-------
IRflXfllP.
IRftWSJft
IRP.HBEB
IRfiCDTP.
ILAVCKA
ISACAMA
ISAOACA
ITANACA
ITABAIA
ITAUAGA
IQAXAFA
INAMCVA
ITBCBVA
IRAEAKA
INASCYA
INASBRA
IRARAFB
IRACCKA
JSBEAIA
1RAEACA
EPft Compendium of Acceptable Uses
0,0-DIIflETHYL 0-(4-N1TRO-M-TOLYL) PHOSPHGROTHIOftTE
Site and Pest
Dosages and Tolerance, use. Limitations
Forniu 1 at i on (s)
fisalea cluster (continued)
Pest list continued from previous page.
ITBUftSft
I RP.CCJfl
Boxwood psyllid
Citrus mealybug
Citrus whitefly
Cottony taxus
scale
(crawlers)
Crapernyrt le
aphid
Elm leaf beetle
Eot et ranych us
spider mites
European pine
sawfly
European spruce
sawfly (pine
sawfly>
Fall cankerworm
Fal1 webworm
Forest tent
caterpi1lar
Hawthorn lace
bug
Imported willow
leaf beetle
Iris borer
Ivy aphid
Meadow spittle-
bug
Northern pine
weevi1
Pales weevil
Pa1merworm
Redpine scale
(crawlers)
Rose aphid
Roses1ug
Saratoga
spittlebug
Southern red
rn i t e
Spruce budworm
Tuliptree aphid
Issued: 7-02-86
III-105901-3
117
-------
EPft Compendium of Acceptable Uses
0,0-DIMETHYL 0- (4-N ITRO-M-TQLYL) PHOSPHOROTHIOflTE
/35098fifi
Site and Pest
Pine
INBQfiOft
Southern
beetle
pine
Dosages and Tolerance, Use, . uimitat ions
Formu1 ati on(s)
Do not use this chemical in
Bastrop and Burleson couties, T/,
without first consulting witn
endangerec species personnel of
Texas Parks and Wildlife or .the
U.S. Fish and Wildlife Service
(telephone 817-334-2961) to en-
sure adequate safeguards for the
endangered Houston toad. Do no~
use within l/£ mile of known rec-
cockaded woodpecker colonies.
Apply spray to individual trees
using hand or power operated
ground application equipment.
1% finished Bark Application. Preventive
spray Treatment. flpply thoroughly to
(8 Ib/gal EC) the point of runoff. Apply from
the grounc level to the first
limbs in early spring or anytime
trees are threatened by infesta-
tion from nearby infested trees.
Repeat at 90 day intervals during
summer and early fall or as lone
as threat of attack exists.
I'/, finished
spray
(8 Ib/gal EC)
Bark application. Remedial Trea~~
ment. Apoly to the point of run-
off. Apply to infested portions
of trees or all sides of logs and
limbs cut from infested trees.
Make application after beetle at-
tack has occurred but prior to
beetle emergence.
GREENHOUSE NONFOOD CROP
(Ornamental Plants and Forest Trees)
/3£OOOCA Greenhouse Ornamentals
Refer to TERRESTRIAL NONFOOD CROP, (Ornamental
Plants and Forest Trees), Azalea cluster, for
pests and use limitations.
Issued: 7-OE-S6
III-105901-4
118
-------
EPft Compendium of flcceptable Uses
f
0,0-DINETHYu 0-(4-NITRO-M-TOLYL> PHOSPHOROTHIOftTE
Site and Pest Dosages and Tolerance. Use, Limitations
Formalat ion(s)
DOMESTIC OUTDOOR
(Hoiisenold.)
/630030ft Domestic Owe 11 inn (Outdoor)
Flies IV. finished Outdoor application. Spray out-
Mosquitoes spray side surfaces of windows and door
(4 Ib/gal EC) frames, and other areas where
these pests may enter the home.
Ptlso, spray dark corners and lo-
calized resting areas (such as un-
oer eaves) or porches, patios and
garages where these pests may con-
gregate. Repeat as necessary.
Dilute with water or deodorized
kerosene (or equivalent grade
oil).
ISftSPtftfl Pints I'/, finished Outdoor treatment. Spray trails,
spray nests and points of entry. Spray
(4 Ib/gal EC) on ants where possible. Repeat
as necessary.
Issued: 7-02-86 111-105901-5 | ]
-------
EPfl Compendium of ftcceptable^ Uses
0,0-D I METHYL 0-<4-NITRQ-M-TQLYL) PHOSPHQROTHIOPlTE
Site and Pest
Dosages and Tolerance. Use, Limitations
Forrnu 1 at i on (s)
FORESTRY
(Ornamental Plants and t-crest Trees)
/30043ftfi
/3006400
ITBURSC
ITBUftSC
RESTRICTED USE PESTICIDE.
This pesticide is toxic to wild-
life and extremely toxic to aqua-
tic inverteprates. Do not apply
directly to water or wetlands
(swamps, bogs, marshes, and pot-
holes) except under the forest
canopy. Drift and runoff from
treated areas may be hazardous to
aquatic organisms in neighboring
areas. Do not contaminate water
by cleaning of equipment or dis-
posal of wastes.
Use limited to the northeastern
United States. Apply under the
supervision of qualified person-
nel responsible for pest control
programs and after a careful pest
population forecast is made on
the infested forest area. Apply
at the peak of fourth instar lar-
val development. Mix in suffi-
cient water or solvent so as to
apply 10 to 20 ounces of"finished
spray per acre by aircraft.
Spruce budworrn 0.125-0.188 Foliar application. Make 2 appli-
(3-4th instar) Ib/A cations 4 to 6 days apart.
(8 Ib/gal EC)
SC/L)
Spruce budworm
(4-5th instar)
1 application Foliar application. When making
0.188 Ib/fi 2 applications allow 4 to 6 days
or between treatments.
2 applica-
tions 0.125-
0.188 Ib/ft
(8 Ib/gal EC)
(9354 SC/L)3
Issued: 7-02-86
III-105901-6
120
-------
EPfl Compendium of Acceptable Uses
0,0-DItfETHYL 0-(4-NITRO-M-TDLYL) PHOSPHOROTHIOflTE
Site arid Pest Dosages and Tolerance. Use, Limitations
Formalat ion(s)
Pine
INBQflOfi
Southern
beetle
pine £% finished
spray
(8 Ib/gal EC)
1% finished
spray
<8 Ib/gal EC)
CSLN:
£ ml of 8
Ib/gal per
inch of tree
d i arnet er at
breast
height
-------
EPfl Compendium of flcceptable Uses
0,D-DIMETHYL 0-<4-!MITRO-M-TOLYL> PHOSPHQROTHIOflTE
Site and Pest
Dosages and Tolerance. Use, Limitations
Forrnulat ion (s)
INDOOR
/540OOJP
IMNftflftfl
/630010ft
/70O01JC
/70002JC
/77000JC
/7OOO5JC
/7OOO6JC
/70034JC
ISflSflflfl
ILftttflZfi
ISBftftftfl
INftBBDfl
IVftftftBft
INBUftTfl
IVftHflfta
IMDfiflflfl
IMPBflBfl
IMNflflftft
ILflBftBfl
IJCflflftfl
General Warnings and Limitations; when used in dwellings, avoid d?
posits which could be freauently contacted by children. Do not
permit children or pets "in treated areas until surfaces are dry.
Do not use in kitchens or food serving areas while food is exposed,
Solvents used in eniulsi f iable concentrate formulations may stain
rubber, and asphalt materials such as tiles and
Do not apply to carpets due to possibility of
spotting of wallpaper and fabrics. Emulsifiable
be diluted with oil.
certain plastic,
floor coverings.
staining. flvoid
concentrates may
(flnirnals and Their Man-made Premises)
Pet Premises
Brown dog tick
Fleas
1% finished
spray
<4, 3 Ib/gal
EC)
Enclosed premises treatment.
Spot treat infested areas such as
pet beds and resting quarters,
nearby cracks and crevices, along
and behind baseboards, window and
door frames and localised areas
of floor coverings. Old bedding
of pets should be removed and re-
placed with clean fresh bedding
after treatment.
(Household)
Domestic Dwellings. Indoor
ftnts
Brown dog tick
Cent ipedes
Cigarette
beetle
Cockroaches
Confused flour
beetle
Crickets
Earwigs
Firebrats
Fleas
Grain mite
Mi 11ipedes
Issued: 7-02-86
154 finished
spray
(4, 8 Ib/gal
EC)
Indoor treatment. ftpply as a
coarse spot spray or apply with &
paint brush to baseboards, stor-
age areas, around water pipes,
behind and under refrigerators,
cabinets, sinks and stoves, under-
side of pallets and similar areas
where pests may hide or enter.
Inspect treated area 14 to 28
days after initial application.
111-105301-8
122
-------
EPft Compendium of Recent able Uses
0,C-DIMETHYL C-(4-NITRC-M-TOLYL) PHOSPHOROTHIOfiTE
i
Site and Pest
IMPBftCft
IIFRflEH
IKflflflftfl
IKflDflflP
/630O5GR
Dosaaes and Tolerance, Use, limitations
Formal at ion(s)
Domestic Dwellings. Indoor (continued)
Pest list continued from previous aage.
Scorpions
Si 1verfish
Sowbugs
Spiders
Tarant uias
(Wide flrea ana General Indoor/Outdoor Treatment)
Domestic Dwellings. Indoor
lORMflJJ
flnopheles
mosquitoes
(adults)
40 ml of 5'/.
finished
spray sq. rn
or
1 kilogram/8
liters/£00
sq. rn
C2 grn/sq. mH
(40-/.
Do not make more than 1 applica-
tion every 3 months. Do not ap-
ply in food areas.
For use only by or under the su-
pervision of state or federal of-
ficials responsible for malaria
control. fipply residual spray to
wail surfaces. Remove occupants,
pets, birds, and cover fish aquar-
iums before application. Food
should be removed and food han-
dling equipment covered during.ap-
plication and or washed after ap-
plication is complete. No fooc!
handling or preparation areas are
to be sprayed. The floor must be
covered before application and
the covering disposed of in accor-
dance with disposal procedures
specified on labeling. flfter
application do not reoccupy until
spray deposits have dried. Do
not make more than 1 application
every 3 months. Before reoccupy—
ing, open all doors and windows
and ventilate thoroughly.
Issued
7-OS-86
I 11-105901-9
123
-------
EPfl Comoend iurn of flcceotable Uses
0,0-DIMETHYL 0-(4-NITRO-M-TOLYL) PHGSPhuROTHIOftTE
Site and Pest Dosages and Tolerance, Use, Limitations
Forrnulat ion (s)
(Commercial and Industrial Uses)
/70001JZ Aircraft (ftreas other than
edible product areas)
/7000iJC Buses (ftreas other than edible
product areas)
/77000JC Commercial, Industrial and
Institutional ftreas (flreas
other than edible product
areas)
/70005JC Railroad Cars (Areas other than
edible product areas)
/7000SJC Trai lers (ftreas other than
edible product areas)
/7000SJC Trucks (ftreas other than edible
product areas)
/70034JC Vessels (ftreas other than
edible product areas)
Refer to INDOOR, (Household), Domestic Dwell-
ings, Indoor, for pest and use information.
Issued: 7-02-86
111-105901-10
124
-------
EPA Compendium of Pcceotabie Lses
0,0-DIMETHYL 0-(4-NITRQ-M-TQLYL) PHCjSPHCRQTHIORTE
Site and Pest Dosages ana Tolerance. 'Jse. -iriiitat..ior.s
Formalat ion(5)
QEEiRiflL. MOTHPROOFING QND THNK i^iix PPPLICQTIQNS
S00150!J fterial flpolicatiori
q
Refer to
FORESTRY
(Ornamerital Plants and Forest Trees)
Fir, Spruce
125
Issued: 7-02-86 111-1059O1-11
-------
EPfl Commend i urn of ftcceotable Uses
0, 0-DItt£THYL 0- (4- N ITRO-M-TOLYL) PHOSPH.ORGTHIOfiTE
Listing of Registered Pesticide Products by Formulation
&095. 000 '. 95'/. tecnnical chemical
D,0-dimethyl 0- (4-nitro-rn-toly 1) phosphorotn ioate (105901)
039398-00004
&025. 02C£. £5. 02% f orrnu 1 at ion intermed i at e
0, 0-airnethyl 0-(4-nitro-rn-toly 1) ohosphorothxoate (105901),
d-cis/trans allethrin (004005), heavy aromatic naphtha (006602)
plus N-octyl bicycloheptenedicarboximide (057001)
039398-00024
&080. OOOi: SO'/, f ormu 1 at i on i nt errned i at e
0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate (105901) plus
aromatic petroleum distillate (006601)
039398-00023
&040.000? 40% wettable powder
0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate (105901)
039398-00009
&104.001Z: 4 Ib/qal ernulsifiable concentrate
0,0-dimethyl 0-(4-nitro-rn-tolyl) phosphoroth ioate (105901) plus
aromatic petroleum distillate (006601)
039398-0002S
0,0-dirnethyl 0-(4-nitro-m-tolyl) phosphorothioate (105901) olus
xylene range aromatic solvent (086803)
000655-00751
& 106. 00 1 £• 8 Ib/nal ernulsi f iable concentrate
0, 0-dirnetnyl 0-(4-nitro-rn-tolyl) phosphorothioate (105901)
039398-00003
0, 0-dirnethyi 0-(4-nitro-m-tolyl) phosphorothioate (105901) plus
xylene range aromatic solvent (086803)
000655-00740 004816-00667 039398-00012 039398-00013
O3939S-00015
(039398-00015) Lft860008 MS860007
&293.0015 93% soluble concentrate/1iguid
0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate (1059O1)
039398-00007 039398-00011
Issued: 7-02-86 111-105901-12
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EPft Compendium of Acceptable Uses
0,0-DIMETHYL 0-(4-NITRO-M-TOLYL) PHCSPHGROTHIOflTE
fippendix fl-1
Listing of Octive Ingredient(s) Found in Combination with the
Report Chemical
Chemical Common Name
Code (source)
O06501 aromatic petroleum derivative
solvent
006601 aromatic petroleum distillate
004005 d-cis/trans allethrin
O06&02 heavy aromatic naphtha
057001 MGK £64
086803 xylene range aromatic solvent
i=.P£l Accept able
Common/Che r,i i c al N a rn e
N-octyl bicyclo-
heptenedicarboxirnide
— Use Common Name
Issued: 7-02-86
111-105901-13
127
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