cvEFA
unitM statM
Environmental Pronction
Agency
OffiMof
PAfticidu and Toxic Sufacttnow
Washington DC 20460
PastieidM
September 1986
Guidance for the
Reregistration of
Pesticide Products
Containing Phosmet
as the Active Ingredient
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GUIDANCE FOR THE
REREG1STRATION OF PESTICIDE PRODUCTS
CONTAINING
PHOSMET
AS THE ACTIVE INGREDIENT
CHEMICAL CODE: 059201
Case No. GS-0242
CAS REGISTRY NUMBER 732-11-6
SEPTEMBER 30, 1986
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Introduction 1
1. Chemical Covered by this Standard 4
1.1 Description of Chemical 4
1.2 Use Profile 5
I.3 Registration History 6
2. Agency Assessment , 7
2.1 Summary 7
2.2 Preliminary Science Findings 10
2.3 Other Science Findings 21
2.4 Tolerance Reassessment 25
3. Regulatory Position and Rationale 29
3.1 Summary of Regulatory Positions and Rationales 29
3.2 Criteria for Registration 35
3.3 Acceptable Ranges and Limits 35
3.4 Required Labeling 36
4. Products Subject to this Standard ' 42
5. Requirement for Submission of Generic Data .... 44
5.1 What are generic data? 44
5.2 Who must submit generic data? 44
5.3 What generic data must be submitted? 45
5.4 How to comply with DCI requirements 45
5.5 Procedures for requesting a change in protocol 47
5.6 Procedures for requesting extensions of time 47
5.7 Existing stocks provisions upon suspension or 48
cancellation
6. Requirement for Submission of Product-Specific Data 49
7. Requirement for Submission of Revised Labeling . . 49
8. Instructions for Submission 50
8.1 Manufacturing-use products 50
8.2 End-use products . 51
8.3 Intrastate products 52
8.4 Addresses ..... 52
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 GFR 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- Product Specific Data Report (End-Use Products)
EPA Form 8580- Formulator's Exemption Statement
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INTRODUCTION
The Registration Standards Program
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 the Federal Insecticide,
Fungicide, and Rodenticide Act (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.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme, giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
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
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 %
I. 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 environment.
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The detailed scientific review, which is not contained
in this document but is available upon request1-, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. During the review of these data, however,
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.
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 3 - "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).
The scientific reviews are available upon request from the
Information Services Section, Room 236, CM#2, 1921 Jefferson
Davis Highway, Arlington, Va. 22202 (Tel: 703-557-4453).
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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 section 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicologi-
cal, 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 section 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. You should notify the Agency
of any information, including interim or preliminary results
of studies, if those results suggest possible adverse effects
on man or the environment. This requirement continues as long
as your products are registered by the Agency.
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1. CHEMICAL COVERED BY THIS STANDARD
The Agency has conducted a review of the scientific
data base on Phosmet. This section of the Registration
Standard describes the chemical and its uses and concludes
with a brief discussion of its registration history.
1.1 DESCRIPTION OF THE CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name; Phosmet
Chemical Name; N-(mercaptomethyl) phthalimide-
S-(O,O-dimethyl phosphorodithioate)
Chemical Abstracts Service (CAS) Number; 732-11-6
OPP (Shaughnessy) Number; 059201
Empirical Formula;
Chemical Structure:
\s
II
s
NN-CH2-S-P(oCH3)j
Trade Names; Phthalofos, PMP, Imidan, Kemolate, Prolate,
R-1504, and Appa
Description of Physical Characteristics^ Information listed
below references the technical grade active ingredient unless'
specified as the pure active ingredient (PAI).
Color: Greyish-white to white
Physical state: Crystalline solid
Odor: Typical phosphorodithioate
Boiling point: Not applicable because the
technical is a solid at room temperature
Flash point: Not available in Agency files
Melting Point: 72.0°C to 72.7°C (PAI)
Solubility: 25 ppm at 20°C
Specific gravity: 1.030 at 20°C
Stability: Not available in Agency files
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'1.2 USE PROFILE
Phosmet is a broad-spectrum organophosphate insecticide/
acaricide. Phosmet's mode of activity involves cholinesterase
inhibition, a process by which the insect is poisoned primarily
by phosphorylation of acetylcholinesterase at the nerve
endings. Phosmet is used for control of a wide variety of
insects including the alfalfa weevil, boll weevil,' codling
moth, leafrollers, plum curculio, grape berrymoth, and
oriental fruit moth. Phosmet is available as a 90 percent
and 94 percent active ingredient technical product for
formulating phosmet end-use products. Technical phosmet
is produced by the Stauffer Chemical Company of Richmond,
California, under the trade names Imidan Technical (90%) and
Prolate Technical (94%). Prolate technical is purer than
Imidan technical and is primarily used in the formulation of
insecticides for control of ectoparasites on livestock and
pets, and animal drugs for control of endoparasites in live-
stock (regulated by the Food and Drug Administration). Imidan
technical is primarily used in the formulation of insecticides/
miticides for use on crop and non-crop areas. Phosmet technicals
are formulated into dusts, wettable powders, impregnated.resins,
and emulsifiable concentrate end-use products.
The vast majority of phosmet usage (over 95 percent) is
for insect control on commercial tree and vine fruit. Approxi-
mately 80 percent of the annual usage is applied to apples
throughout apple production regions in the northeastern and
western U.S., while 6 percent is applied to pears. The
remaining 9 percent of the usage on tree and vine fruits
is distributed mainly among peaches, cherries, almonds,
plums, prunes, and grapes. Other sites of phosmet use
include alfalfa, cotton, corn, nursery and ornamental plants
and shrubs, fire ant mounds, pets and livestock. Of these
sites, alfalfa usage contributes the largest annual percentage
(3-4 percent). Application rates for the major crops uses
(apples, alfalfa, and pears) range from 0.75 to 15 pounds
active ingredient per acre depending on the type of pest and
the amount of infestation. :
Phosmet is applied to terrestrial food and non-food
areas as a delayed dormant or foliar application with
aerial or ground equipment, primarily using concentrate and
semi-concentrate sprays. Livestock treatments (beef cattle
and swine) are done by dusting, spraying, or dipping. Pet
treatments include the use of a 5 percent dust or a 15
percent flea collar.
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1.3 REGISTRATION HISTORY OF PHOSMET
The organophosphate chemicals were developed as a result
of the research of Schrader in Germany just prior to World War
II. However, since these compounds were intensively studied
as chemical warfare agents, their development was not publicized
until after the end of World War II.
Phosmet was patented by Stauffer Chemical Company in 1956
and was first registered for use in the United States by Stauffer
in 1966. The formulation types currently registered include
dusts (1 percent and 5 percent active ingredient), wettable
powders (7.5, 12, 12.5, 50, and 70 percent active ingredient),
impregnated resins (15 percent active ingredient), and emulsi-
fiable concentrates (1 and 3 pound per gallon and 12.5 percent
active ingredient).
There are 24 federal section 3 registrations (8 companies
[Tobacco States Chemical Company, Stauffer Chemical Company,
Robins G.& S. Company, Zoecon Industries, Aceto Chemical Company,
Ford Chemical Service Incorporated, Zoecon Corporation, and
Unicorn Laboratories ), and 15 section 24(c) Special Local
Need registrations with phosmet as the sole active ingredient.
In addition there is one federally registered section 3
product containing phosmet in combination with another active
ingredient (other than solvents). There are no intrastate
products for phosmet.
In accordance with the Agency's ongoing Data Call-In
(DCI) Program, the Agency issued three separate DCI notices on
phosmet. A June 20, 1983 DCI notice requested certain chronic
health effects data, while two additional notices, issued June
29, 1984 and February 28, 1985, required the submission of
groundwater and reentry data respectively. The current phosmet
registrations and any future applications for registration of
products containing phosmet will be subject to the Agency's
regulatory position as set forth in this Standard.
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2. AGENCY ASSESSMENT
2.1 SUMMARY SCIENCE STATEMENT
The Agency has reviewed data submitted to support the
registration of phosmet and any other pertinent data available
in Agency files. As a result of this review, the Agency has
determined that certain changes in the conditions of regis-
tration, including specific label restrictions and submission
of missing data, are necessary to maintain current registrations
of products and support registration of new products containing
phosmet. A summary of these data gaps and label revisions
appears in Figure 1. Note that the list contains only summary
information on the data gaps and more detailed information can
be obtained by referring to Table A in Appendix 1.
Based on a review of the available data the Agency has
reached the following interim conclusions. A detailed discuss-
ion of the points summarized below is contained in section 2.2.
o Phosmet has been classified as a "tentative" Category C
(possible human) carcinogen based on the following:
Phosmet was associated with a significantly elevated
incidence of liver tumors (adenomas, and adenomas plus
carcinomas combined) in male B6C3F^ mice at the highest
dose level tested (HDT). These incidences were associated
with liver hyperplastic changes and a decrease in the
time to tumor occurrence. In female BGCSF^ mice, the
chemical was associated only with positive dose-related
trends for liver adenomas and carcinomas.
However, the Agency has some reservation in the classifi-
cation of phosmet as a Category C oncogen. The label
"tentative" Category C has been assigned until a repeat
two-year rat oncogenicity study and additional mutagenicity
studies are submitted and considered in conjunction with
the mouse oncogenicity results.
o Phosmet has moderate to low acute oral, dermal, and eye/
skin irritation toxicity. The chemical has been assigned
to Toxicity Category II due to acute oral toxicity.
Additional testing (acute inhalation and dermal sensitization)
is required to complete the acute toxicity profile for
technical phosmet. Insufficient data exist to fully assess
subchronic dermal, mutagenicity, oncogenicity and the general
metabolism of phosmet. Reentry data are necessary in order to
establish permanent worker reentry intervals.
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o Laboratory data show that phosmet is highly toxic to fish,
other aquatic organisms, and bees. The use of phosmet
as a miticide on apple and pear orchards, alfalfa, corn
and cotton may threaten endangered aquatic organisms
and two endangered insect species.
o The environmental fate data on phosmet do not meet the
Agency's current testing standards. The environmental
fate of phosmet is therefore largely uncharacterized
and the data are inconclusive and insufficient to fully
assess the fate and persistence of phosmet in groundwater
and the environment.
o Phosmet is used primarily with powered spray equipment
for overhead spraying in commercial tree and vine fruit
and nut orchards, and spraying and dusting of livestock.
Based on the potential for applicator exposure to phosmet
from these uses and the lack of dermal sensitization and
21-day dermal toxicity studies, the Agency is requiring
that protective clothing be worn by mixers/loaders and
applicators. The Agency is also requiring a special glove
permeability study.
o The Agency is requiring plant/animal metabolism and
residue data to determine the nature of the residues in
plant and animals, and to assure that all metabolites of
concern have been identified. Also required are pro-
cessing studies on apples, potatoes, plums, peaches,
grapes, field corn grain, and cottonseed to more
accurately assess dietary exposure.
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FIGURE 1
SUMMARY OF DATA GAPS AND REQUIRED LABELING
PHOSMET
Toxicology
Acute Inhalation Toxicity (rat)
Dermal Sensitization
21 Day Dermal (rabbit)
Oncogenicity (rat)
Mutagenicity Testing
General Metabolism
Ecological Effects
Acute Toxicity to Freshwater Invertebrates (on end-use product)
Acute Toxicity to Estuarine and Marine Organisms (on end-use product)
Fish Early Life Stage and Aquatic Invertebrate Life-Cycle
Field Monitoring (avian, aquatic, and mammalian)
Environmental Fate
Hydrolysis/Photodegradation Studies
Anaerobic Soil Metabolism
Mobility Studies
Field Dissipation
Accumulation (rotational crops)
Glove Permeability
Reentry
Product Chemistry/Residue Chemistry
Product Chemistry
Plant/Livestock Metabolism
Plant/Animal Residues
Storage Stability
Labeling Revisions
Protective Clothing
Reentry Restriction
Fish and Wildlife Toxicity Warnings
Endangered Species Warnings
Domestic Pet Warnings
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2.2 PRELIMINARY SCIENCE FINDINGS
This subsection summarizes the results of studies and
reports to the Agency relating to the acute and chronic
toxicity of phosmet.
2.2.1 ACUTE TOXICITY
Acute toxicity studies submitted in support of the
registration of phostnet technical satisfy the data requirements
for acute oral and dermal toxicity, primary eye and dermal
irritation, and acute delayed neurotoxicity. Phosmet, like
other organophosphates, can be absorbed by inhalation and skin
penetration. The extent of dermal absorption may be slight
however, as evidenced from the low toxicity by the dermal route.
Signs of acute intoxication to exposure are primarily related
to cholinesterase inhibition and include headache, dizziness,
weakness, loss of coordination, nausea and respiratory depression.
The acute inhalation and 21-day dermal studies are
not acceptable and must be repeated. There are no studies
available on the dermal sensitization potential of phosmet
therefore this test data must be submitted.
Acute oral toxicity: The acute oral LD5Q (lethal dose) of
technical phosmet in rats has been reported in several studies
to range from 113 milligrams (mg) per kilogram (kg) to 304
mg/kg. The acute oral LD5Q of technical phosmet in mice in
two studies ranged from 38 mg/kg to 50.1 mg/kg. The Agency
has assigned phosmet to Toxicity Category II (moderately
toxic by the oral route of exposure) based on the results of
studies conducted in the rat because the rat is the preferred
test species.
Acute dermal toxicity: The acute dermal 11)50 of technical
phosmet in rabbits has been reported in three separate studies
to be greater than 3,160 mg/kg. The Agency has assigned
phosmet to Toxicity Category III (mildly toxic by the dermal
route of exposure) based on the results of the above studies.
All three of these studies together satisfy the requirement
for an acute dermal toxicity study.
Acute inhalation toxicity: The acute inhalation LCt5o (lethal
concentration)in rats has been reported to be greater than
0.152 milligrams per liter (mg/1) after exposure for four hours.
The study was considered unacceptable because technical phosmet
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should have been tested at multiple dose levels in the form of
particulate matter as opposed to the single dose level of
phosmet in vapor form. The appropriate toxicity category
could not be determined since no deaths occurred at the
one level tested. A repeat acute inhalation toxicity study
must be submitted.
Primary eye irritation: The Agency reviewed two primary eye
irritation studies.Tn one study technical phosmet produced
mild redness when instilled in the unwashed eyes of three
rabbits at 24 hours after exposure. The eyes returned to
normal within 7 days. In the other study phosmet produced
corneal opacity, redness, chemosis, and discharge in 1 of 3
rabbits. The irritation was reversible within 7 days. The
Agency has assigned phosmet to Toxicity Category III (mild
irritation) based on these results. The two studies together
satisfy the requirement for a primary eye irritation study.
Primary dermal irritation: In a study using six albino
rabbits technical phosmet produced no irritation when applied
to intact or abraded skin on the backs of the rabbits (non-
irritant). The Agency has assigned phosmet to Toxicity
Category IV for primary dermal irritation based on these results.
This study meets the Agency requirement for a primary dermal
irritation study.
Acute delayed neurotoxicity: The Agency reviewed four
studiesin which technical phosmet was tested for its poten-
tial for causing delayed neurotoxicity. In one study phosmet,
administered to White Leghorn hens at levels up to 1000 parts
per million (ppm) for six weeks, failed to produce delayed
neurotoxicity. In a second study phosmet administered to
unspecified "birds" at levels up to 1,413 mg/kg (2 doses separ-
ated by a 3 week observation interval) failed to produce delayed
neurotoxicity. In a third study questionable positive effects
were observed at a level of 60 mg/kg. Due to the contradicting
evaluations of clinical signs and/or histopathological data by
several authors of the report, it was decided to repeat the
study. A fourth study was conducted in which no delayed neuro-
toxic effects were observed in adult hens administered phosmet
at levels up to 2,050 mg/kg, however body weight, food consumption,
and egg production were significantly decreased in the 2,050
mg/kg test group. Based upon these results, which together
meet the requirements for an acute delayed neurotoxicity study,
the Agency has determined that phosmet is not a delayed neurotoxin.
2.2.2 SUBCHRONIC TOXICITY (ORAL)
Although subchronic oral toxicity studies were conducted
in the dog and rat they were not evaluated since the chronic
feeding studies satisfy the requirement for a subchronic
feeding study-
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21-day repeated dose dermal toxicity; A repeated dose dermal
reproduction study has been conducted on phosmet technical
under the context of conducting an oral/dermal one-generation
reproduction study. Rabbits were administered phosmet either
by the oral or dermal route. Cholinesterase depression ranged
from slight to marked depending on the dose level, and some
local dermal effects (hyperkeratosis) were noted. A NOEL was
not demonstrated for cholinesterase inhibition. A 21-day
dermal toxicity study was conducted in rabbits with Imidan
50-W and Imidan 3-E but again NOELs could not be established.
A second series of 21-day dermal toxicity studies were con-
ducted with Imidan 50-W and Imidan 3-E, again, however,
NOELs could not be determined. The studies do not satisfy the
requirement for a repeated-dose dermal toxicity study. These
data are being required.
2.2.3 ONCOGENICITY STUDIES
Rat: Phosmet was administered in the diet to 25 Charles River
strain albino rats/sex/dose level at doses of 0, 20, 40, and
400 parts per million (ppm) for 2 years. The study was conducted
by Stauffer Chemical Company in the 1960"s. No tumors were
observed that were considered to be related to treatment with
phosmet. However, there appeared to be a large proportion of
rats sacrificed at the end of the study in the mid and/or high
dose groups that showed the presence of pituitary adenomas and
thyroid adenomas. The incidences of pituitary adenomas were
a) Males: 3/10 or 30%, control; 1/10 or 10%, low dose; 6/10 or
60%, mid dose; and 4/7 or 57%, high dose; and b) females 6/17
or 35%, controls; 3/13 or 23%, low dose; 5/10 or 50%, mid-
dose; and 6/12 or 50%, high dose. The incidences of thyroid
adenomas were a) Males: 0/13 or 0%, controls; 0/13 or 0%, low
dose; 2/13 or 15%, mid dose; and 2/14 or 14%, high dose; and
Females: 1/19 or 5%, controls; 2/14 or 14%, low dose; 0/19 or
0%; mid dose; and 2/16 or 13%, high dose. The Agency recognized
that the number of animals sacrificed at the end of the study
were too small to fully evaluate these tumor responses. In
addition, although the study might be considered acceptable
according to criteria for studies conducted many years ago, it
is inadequate according to modern standards in terms of the
number of surviving animals available for gross and histo-
pathological examination.
In addition, the limited data available for this study
made it difficult to determine whether or not a maximum toler-
ated dose (MTD) was tested. The toxicological effects that
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were reported at the highest dose level tested, i.e., 400 ppm,
included 1) decreases in plasma, brain and erythrocyte
cholinesterase levels of greater than 20% (the Agency recog-
nizes that changes of +_ 20% in these parameters are common
based on experimental technique), 2) weight loss ranging from
13% to 17% in males and 0% to 10% in females at various intervals
during the study, and 3) "moderate" liver cell vacuolation.
Based on these data, it was determined that the mid dose level,
i.e., 40 ppm, was a NOEL, for chronic effects (other than onco-
genicity) and that the highest dose level tested, i.e., 400
ppm, may have been close to a MTD level. In order to resolve
the issue of the potential oncogenicity of phosmet a repeat
oncogenicity study in rats is required.
Mouse; Phosmet was administered in the diet to 60 B6C3Fi
mice/sex/dose level at doses of 0, 5, 25 and 100 ppm for 2
years. Ten mice/sex/dose group underwent interim sacrifice at
12 months after the start of the study. The study was conducted
by Stauffer Chemical Company between April 1981 and May 1983.
The following chart outlines the incidence patterns of liver
tumors in male and female mice suggestive of a compound related
effect.
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Mouse Oncogenicity Data
Liver Tumor Type Dose (ppm)
& Observation Time Sex 05 25
Interim Sacrifice3
Adenoma M 0/10(0%) 1/10(10%) 1/10(10%)
Carcinoma M 0/10(0%) 0/10(0%) 1/10(10%)
Combined M 0/10(0%) 0/10(0%) 2/10(20%)
Final Killb
Adenoma M 9/49(18%) 9/50(18%) 11/50(20%)
Carcinoma M 14/49(24%) 11/50(20%) 10/50(22%)
Combined M 23/49(47%) 20/50(40%) 21/50(42%)
Total (Interim
Sacrifice & Final
Kill)
Adenoma M 9/59(15%) 10/60(17%) 12/60(20%)
Carcinoma M 14/59(24%) 11/60(18%) 11/60(18%)
Combined M 23/59(39%) 21/60(35%) 23/60(38%)
Final Killb
Adenoma F 5/48(10%) 4/50(8%) 5/48(10%)
Carcinoma F 5/48(10%) 4/50(8%) 3/48(6%)
Combined F 10/48(20%) 8/50(16%) 8/48(16%)
Total (Interim0
Sacrifice & Final
Kill
Adenoma F 5/58(9%) 4/60(7%) 5/58(9%)
Carcinoma F 5/58(9%) 4/60(7%) 3/58(5%)
Combined F 10/58(18%) 8/60(14%) 8/58(14%)
a = Interim sacrifice values were obtained at study week 52 for
mice/sex/dose level.
b = Final kill values include mice sacrificed at study week 104
all intercurrent deaths occurring after study week 52.
c = Total values include interim sacrifice value plus final kill
intercurrent deaths occurring after study week 52.
100
2/10(20%)
1/10(10%)
3/10(30%)
19/50(38%)'
13/50(26%)
32/50(64%)'
21/60(35%)!
14/60(23%)
35/60(58%)'
9/50(18%)'
9/50(18%)
18/50(36%)'
9/60(15%)
9/60(15%)
18/60(30%)
10
plus
and
T = Significant (p < 0.05) positive dose-related trend using Cohran-
Armitage Trend Test.
* = p < 0.05 compared to controls using Fisher-Exact Test.
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An elevated incidence of liver tumors was observed in both
male and female BGCSF^ mice. In the male mice, tumors were
observed both at the interim kill period (52 weeks) and at the
time of the final sacrifice (104 weeks). At the interim kill
period, there was a statistically significant (p<0.05) positive
trend for adenomas/carcinomas combined. In addition, at the
final sacrifice period, there were statistically significant
(p<0.05) positive trends for adenomas per se, and for adenomas/
carcinomas combined. The incidence of adenomas was also signi-
ficantly (p<0.05) elevated in high dose male mice, whereas the
incidence of carcinomas was not increased. When the total
number of animals for which tissues were histologically examined
at interim sacrifice plus the final kill period were evaluated,
there were also statistically significant (p<0.05) positive
trends for adenomas per se, and for adenomas/carcinomas combined.
The incidences of adenomas per se, and adenomas/carcinomas
..combined, were also significantly (p<0.05) elevated in high
dose male mice. In addition, there was evidence for liver
hyperplasia in the high dose males as indicated by the appearance
of clear cell foci both at interim sacrifice (0% controls, 0%
low dose, 0% mid dose, and 10% high dose) and at final sacrifice
(8% controls, 12% low dose, 10% mid dose, and 26% high dose).
In the female mice positive trends for tumors were observed
only at the time of final sacrifice (104 weeks) but not at the
interim kill period (52 weeks). At the final sacrifice period,
'•there were statistically significant (p<0.05) positive trends
for adenomas per se, carcinomas per se, and for adenomas/carcinomas
combined. However, none of these individual tumor types were
significantly elevated in high dose female mice., Finally,
results similar to these were obtained in female mice when the
total number of animals for which tissues were histologically
examined in the study at interim sacrifice plus the final kill
period were evaluated. Although, there was some indication of
liver hyperplasia in females at interim sacrifice when no
tumors occurred (i.e., clear cell foci occurred in 0% of control,
0% low dose, 9% mid dose, and 20% high dose females). there
were no clear cell foci observed in female livers at the final
sacrifice period when positive trend tumors were noted.
In summary, phosmet produced an increase in heptocellular
adenomas (also reflected as an increase in the incidence of
adenomas/carcinomas combined) at the highest dose level tested
(100 ppm) in male mice. No significant increase in carcinomas
occurred, indicating that there was no clear trend of progression
of benign tumors progressing to malignancy. However, there was
evidence for liver hyperplasia in male mice. There was also an
indication from the interim sacrifice results that the liver tumors
occurred in male mice with a reduced latency- Phosmet also produced
positive trends for adenomas, carcinomas, and both tumor types
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combined, in female mice, but none of these tumors were signi-
ficantly elevated at the highest dose level tested (100 ppm) ,
there was no hyperplasia, and no indication that the tumors
occurred with a reduced latency period.
The phosmet liver tumor data were compared with historical
control tumor data from the National Toxicology Program (NTP)
data base (Goodman et. al., Handbook of Carcinogen Testing,
pg. 291, 1985). For male mice the comparison indicated that
at the time of the final kill, the increased incidences of
adenomas (38%) and adenomas/ carcinomas combined (64%) seen in
high dose male mice exceeded the historical range of these
tumor types seen in the NTP studies (i.e., range of 0-24% for
adenomas, and range of 16-58% for adenomas/carcinomas combined).
For female mice the comparison indicated that at the time of
the final kill, the increased incidences of carcinomas (18%)
and adenomas/ carcinomas combined (36%) seen in high dose
female mice exceeded the historical range of tumor types seen
in the NTP studies (i.e., range of 0-15% for carcinomas, and
range of 0-20% for adenomas/carcinomas). Historical data
available from a single study in B6C3F^ mice conducted at
Stauffer Chemical Company, was of limited use because only
average tumor values not range data were available.
In the chronic mouse bioassay, the highest dose (i.e.,
100 ppm) tested appeared to approximate a MTD level in both
males and females. The effects seen at this dose included:
a) reductions of plasma and brain cholinesterase activity and
increases in liver weight in both male and females; b) microscopic
pathological changes in the livers of male mice (degeneration
and vacuolation of individual cells and foci of eosinophilic
cells) and in female mice (mid zonal degenerative vacuolation,
necrotizing inflammation, and cell necrosis of individual liver
cells); c) convulsions, stomach mucosal hyperplasia, testicular
atrophy, and perivasculitis of muscle in males; and d) inflammation
of the stomach and duodenum and myometrial atrophy of the uterus
in females.
Additional Data Utilized in the Evaluation of Oncogenic Effects;
Two year dog toxicity study; A 2-year study of phosmet was con-
ducted in purebred beagles. The chemical was administered in
the diet to 3 dogs/sex/dose level at doses of 0, 20, 40 and
400 ppm. This NOEL was 40 ppm. The LEL (lowest effect level)
was 400 ppm based upon the finding of brain and erythrocyte
cholinesterase inhibition. No unusual target organ effects were
noted.
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Metabolism studies; Three similar metabolism studies were
performed in which single oral doses of 14-C phosmet (doses
ranging from 19 to 31 milligrams per kilogram (mg/kg) were
administered to Long-Evans rats. The animals were sacrificed
3 to 5 days after dosing. Absorption from the GI tract
appeared to be rapid and fairly complete. After 72 to 96
hours, approximately 78-79% of the administered radioactivity
(RA) was eliminated in the urine and approximately 18-19% of
the RA was eliminated in the feces. The major water soluble
urinary metabolites have been tentatively identifed as
phthalamic acid (51-54%), phthalic acid (16-21%), and a
derivative of phthalic acid (7-9%). The major water soluble
metabolite tentatively identified in the feces was phthalamic
acid. No unchanged phosmet was found in the urine. Less than
0.04% of the RA was eliminated as CC>2« Tissue residues
accounted for 2.6 to 3.5% of the administered RA. There does
not appear to be any selective localization of RA in any
tissue. These data are not considered acceptable under
current standards because more rigorous methods should
have been used to identify the metabolites and more details
included to justify the results.
Mutagenicity assays; Phosmet was evaluated in several muta-
genicity tests. The chemical was found to be positive only
when tested in E>. typhimurium strain TA-100 without metabolic
activation. In contrast, the chemical was found to be negative
in all other tests. These tests included tests with
53. typhimurium strains TA-98, TA-1535, TA-1537 and TA-1538
with and without metabolic activation, £^. typhimurium strain
TA-100 with metabolic activation, and a reversion assay with
E. coli strains B/r WP2 hcr+ and WP2 hcr~ and a rec~ assay
with B. subtilis Hi7 Rec+ and M45 Rec~ without metabolic
activation. No mutagenicity study of phosmet was performed
in mammalian cells in culture.
Reproduction and teratology studies; Data from several
reproduction/teratology studies were considered. In a
3-generation reproduction study in rats, no adverse repro-
ductive effects occurred at the highest dose tested (HDT)
80 ppm. In a one-generation reproductive/teratology study
in rabbits, no adverse reproductive or teratological effects
occurred at the HDT (60 mg/kg). In four other teratology
studies performed in monkeys, rats (2 studies), and rabbits,
no teratologic effects were noted at HDT levels ranging from
8 to 35 mg/kg.
Structure-activity considerations; Phosmet contains the
mercaptomethylphthalimide moiety as its primary structural
configuration, A computer based search on the Chemical
Information System (CIS) generated a list of 16 additional
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chemicals that also contained this moiety. A literature
search conducted over several National Library of Medicine
databases failed to uncover any studies to indicate that any of
the 16 chemicals are carcinogenic or mutagenic. Phosmet is
also structurally similar to folpet, which contains the
phthalamide moiety, and is known to produce intestinal tumors in
mice and to be mutagenic in in vitro systems. However, folpet,
unlike phosmet, contains a side chain which is thought to
convert to thiophosgene, a highly reactive chemical believed
to be responsible for producing intestinal tumors in mice.
Weight of Evidence Considerations for Oncogenicity;
The following facts were considered to be important in a
weight of evidence determination of oncogenic potential and
classification of phosmet.
1. In male BgCsFl mice, phosmet produced a significantly
elevated incidence of heptocellular adenomas (also reflected
as an increase at the highest dose tested (i.e., 100
ppm). The adenomas occurred with a reduced latency, were
associated with evidence of liver hyperplasia, and exceeded
National Toxicology Program (NTP) historical control
incidences, but did not progress to carcinomas.
2. Phosmet was associated with significant positive
dose-related trends for liver adenomas and for liver
carcinomas in female B6C3F^ mice. The incidence of
tumors was not significantly elevated at the highest
dose tested, did not occur with a reduced latency, and
was not associated with liver hyperplastic changes.
However, the carcinomas (but not the adenomas) did
exceed the NTP historical incidence for carcinomas.
3. The highest dose tested (100 ppm in the diet) in
the chronic mouse bioassay appeared to be approximately
a maximum tolerated dose (MTD) in both males and females.
4. Phosmet was reported to be not oncogenic when admini-
stered in the diet to Charles River albino rats at doses
ranging from 20 to 400 ppm. This test however was not
considered to be an acceptable negative study by present
day standards due to the fact that only very small numbers
of animals were histopathologically evaluated after 2
years.
5. Phosmet was tested for mutagenicity in a series of
in vitro microbial assays. A positive mutagenic response
was obtained only in one bacterial strain (S^ typhimurium
TA-100) whereas negative results occurred in tests in
several other procaryote strains (j3. typhimurium TA-1535,
TA-1537, TA-1538, and TA-98; E. coli B/W WPs hcr+ and WP2
her-; and B. subtilis H17 Rec+ and M45 Rec~). The
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battery of mutagen.icity studies performed on phosmet was
limited and additional studies must be performed
(e.g., mammalian cells in culture).
6. Metabolism data for phosmet in Long-Evans rats
indicated that phosmet, which is a lipophilic molecule,
was rapidly absorbed, metabolized, and excreted primarily
in the urine. The major metabolites identified in urine
and/or feces were phthalamic and phthalic acids. No
unusual tissue localization of the compound occurred.
These data however were not considered acceptable under
current standards due to the fact that more rigorous
methods should have been used to identify the metabolites
and more details included to justify the results.
7. No teratogenic effects were reported for phosmet
in oral teratology studies in monkeys, rats, arid rabbits.
The compound has no adverse reproductive performance
effects in oral reproduction studies in rats and rabbits.
8. Sixteen structural analogues of phosmet were
identified following a computerized data base search
using the Chemical Information System (CIS). No
carcinogenity or mutagenicity studies were performed
on any of these analogues according to a National
Library of Medicine data base literature search.
Phosmet is also structurally similar to folpet, a
known oncogen (intestinal tumors) and mutagen in mice.
The oncogenicity of folpet is thought to be due to
conversion of its side chain to thiophosgene; this side
chain is not present in phosmet.
Based upon the above "weight of evidence" considerations
and the criteria* contained in the proposed Guidelines for
Carcinogen Risk Assessment (Federal Register Notice of
* These guidelines categorize the evidence on carcinogenicity
of chemicals in terms of how likely it is that the chemical
is a human carcinogen. Under this scheme, Group A, "Human
Carcinogen", is reserved for those chemicals for which there
is sufficient evidence of carcinogenicity from human epidemic-
logical studies. Group B, "Probable Human Carcinogen," is
divided into subgroups 1 and 2. Group Bl requires some human
epidemioiogical evidence. Group B2 is said to be an appropriate
categorization if there is "sufficient evidence" of the chemical's
carcinogenicity from animal studies. "Sufficient evidence" is
defined as an increased incidence of malignant tumors (or combined
malignant and benign tumors) — (a) in multiple species or strains,
(b) in multiple experiments, or (c) to an unusual degree with regard
to incidence, site or type of tumor, or age of onset. Group C,
"possible human carcinogen," is said to be appropriate if there
is, among other things, "definite malignant tumor response in a
single well conducted experiment"; that is, "limited evidence"
from animal studies. (There is also a Group D, "Not Classified,"
and a Group E that is reserved for chemicals shown to be non-
carcinogenic in animal and/or human studies.
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November 23, 1984 - 49 FR 46294) the Agency concluded that
there was limited evidence of phosmet's carcinogenicity and
phosmet should be classified as a Category C (possible human)
carcinogen. The Agency has some reservation in the classi-
fication of phosmet as a Category C oncogen because of the
lack of an acceptable oncogenicity study in a second rodent
species and acceptable mutagenicity data. Therefore, the
label "tentative" Category C has been assigned until a repeat
two-year rat oncogenicity study and additional mutagenicity
studies are submitted and considered in conjunction with the
mouse oncogenicity study.
2.2.4 CHRONIC EFFECTS (NON-ONCOGENIC)
Rat; The oncogenicity study described above also served as
a chronic feeding study because it provided results on
non-oncogenic effects in addition to oncogenic effects.
Details of this study are presented under "Oncogenicity"
above. The Agency concluded that this combined chronic
feeding/oncogenicity study satisfied the requirement for a
chronic feeding study in rats. The study results indicated
a NOEL of 40 ppm for chronic effects other than oncogenic.
Non-rodent (dog); The Agency has reviewed a non-rodent chronic
feeding study in which beagle dogs were administered technical
phosmet in the diet at levels of 0, 20, 40, and 400 ppm for 2
years. Erythrocyte and brain cholinesterase activity was
inhibited at the 400 ppm level. The "no observable effect level"
(NOEL) was demonstrated to be 40 ppm. The Agency considers
this study to have satisfied the requirement for a chronic
non-rodent feeding study.
Mutagenicity; A dominant lethal ("embryotoxicity") study was
conducted in the rabbit, however, insufficient information was
available to assess the results of the study. The requirements
for mutagenicity studies have not been satisfied.
Metabolism; The results of three metabolism studies indicate
that phosmet is rapidly eliminated with 78 percent excreted in
the urine and 19 percent in the feces within 72 hours after
administration of a single oral dose to rats. The major water
soluble urinary metabolites have been "tentatively" identified
as phthalamic acid (51 to 54%), phthalic acid (16 to 21%), and
a derivative of phthalic acid (7 to 9%). The major water
soluble metabolite "tentatively" identified in the feces was
phthalmic acid. The requirement for a metabolism study has
not been satisfied because the methods employed to identify
the metabolites lacked sufficient detail to confirm/validate
the results reported.
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Teratogenicity - rabbit; In a one-generation teratology study
technical phosmet was fed and dermally applied to New Zealand
White rabbits at dose levels of 0, 10, 30, and 60 mg/kg for
three weeks prior to and during the 18 days following mating.
Weight gain was decreased in animals fed 60 mg/kg. Cholines-
terase depression ranged from slight to marked in the 3 oral
dose groups. No teratogenic effects were noted at the 60
mg/kg dose, which was the highest dose tested (HOT). The
teratogenic NOEL was determined to be 60 mg/kg.
Teratogenicity - monkey; In this study phosmet was administered
to monkeys(Macaca mulatta) at levels of 2,0, 4.0, and 8.0
mg/kg from day 22 through 32 of gestation. Pregnancy was
terminated on the 84th day of gestation. Administration of
phosmet did not produce teratogenic effects at the HDT- The
teratogenic NOEL was demonstrated to be 8.0 mg/kg. Although
the highest dose level tested in this study was low when compared
with the rodent dose levels, the Agency concluded that because
the monkey is more closely related to humans than rodents the
dosing used here was adequate to assess the teratogenic effects.
The study satisfies the requirement for a teratogenicity study
in a second species.
Reproductive effects - rodents; In a three-generation reproduction
study technical phosmet was administered to FQ Charles River
albino rats in the diet at a level of 40 ppm. After production
of FI litters, the pups (F^-,) received either 40 or 80 ppm
doses of phosmet. This dosing regimen was maintained through
the production of the third generation, No reproductive effects
from the administration of phosmet were observed. The reproductive
NOEL was determined to be 80 ppm. This study satifies the require-
ment for a reproductive study.
2.3 OTHER SCIENCE FINDINGS
2.3.1 ECOLOGICAL CHARACTERISTICS
This subsection summarizes the toxicity of phosmet to
fish and wildlife.
Avian species; The data base used to assess the acute and
subacute toxicity of phosmet to birds is complete. Phosmet
is practically non-toxic to slightly toxic to birds. The
acute oral LD5Q for the technical grade material was determined
to be 2009 mg/kg. Subacute dietary LC5Q's (lethal concentration)
of 501 ppm, 3146 ppm, and >5000 ppm were determined for bobwhite
quail, ring-necked pheasant, and mallard ducks, respectively,
for technical phosmet. Residues on avian feed items, immediately
after application at maximum application rates (eg. apple orchards
the most common use), are expected to approximate 90 ppm.
Therefore, residues on avian food items immediately following
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applications of phosmet at maximum rates are not expected to
produce lethal poisonings, given phosmet's low systemic toxicity.
In regard to chronic effects, the level of phosmet in the
feed which produces no reproductive impairment is between 60
and 150 ppm for bobwhite quail and between 25 and 60 ppm for
mallards. The expected residue levels on avian food items noted
above, if maintained over the course of the breeding season (which
is possible since phosmet use patterns call for repeated applica-
tion) , may be sufficient to produce reproductive impairment.
Therefore the Agency is requiring actual residue monitoring
of avian feed items from the use of phosmet on apples, corn,
cotton, and alfalfa to complete an evaluation of the repro-
ductive hazard.
Mammals; The toxicity of phosmet to mammals is low (rat
LD5Q = 113 to 304 mg/kg). therefore it is unlikely that
mammals would be killed by a single application. The repro-
ductive NOEL for rats is 80 ppm. Similar to birds, mammals
such as rabbits, may be exposed to residues causing repro-
ductive effects when phosmet is applied to alfalfa and
orchards.
The Agency is requiring actual residue monitoring of
mammalian feed items from alfalfa and orchard use to complete
an evaluation of the reproductive hazards to mammals.
Insects; Studies indicate that phosmet is highly toxic to
honeybees and displays extended residual toxicity. Due to
its high toxicity, precautionary labeling is being required for
phosmet products intended for foliar application. The labeling
statement will instruct the user not to apply the product
when there is bee activity at the treatment site.
Aquatic species; Based upon laboratory data the Agency has
characterized phosmet as very highly toxic to warmwater
fish and highly toxic to coldwater fish. The chemical is also
very highly toxic to aquatic and estuarine invertebrates.
Acute 96-hour LC5Q1s of 230 parts per billion (ppb) for
rainbow trout and 70 ppb for bluegill sunfish have been deter-
mined for technical phosmet. A 48-hour £€59 (effective
concentration) of 5.6 ppb was determined for Daphnia magna
exposed to technical phosmet. Acute 96-hour LCso of 4.2 and
2.0 ppb were determined for Gammarus fasciatus. Terrestrial
residue analysis and aquatic runoff modeling indicates further
that certain use patterns of phosmet could result in exposure
of certain aquatic organisms to potentially hazardous levels
of the pesticide.
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Because of the potential toxicity of phosmet to aquatic
species, the Agency is concerned about the direct and indirect
hazards posed to the aquatic environment by repeated crop
applications of phosmet. Those terrestrial food crop uses
where aquatic contamination is of primary concern are corn/
alfalfa, cotton, and citrus where drift, runoff, and soil
erosion of phosmet to lakes, streams, ponds, other bodies of
water, and wetlands may occur. Because of these aquatic con-
tamination concerns, the Agency is requiring precautionary
labeling for aquatic organisms. In addition, the Agency is
requiring additional acute and chronic fish and invertebrate
tests and field monitoring to evaluate the potential toxicity
to these organisms from terrestrial crop applications that may
result in aquatic contamination.
Endangered species; Hazards to endangered species posed by
phosmet use on corn, cotton and other food uses have been
examined. In addition, informal consultations between EPA and
^he Office of Endangered Species (OES) have raised concerns
about the hazards to endangered species, primarily aquatic
species, from phosmet use on apples, pears, corn, cotton, and
alfalfa. Considering the high toxicity of phosmet to aquatic
organisms, the potential for aquatic contamination from
terrestrial crop applications and information obtained from
consultations with OES, the Agency has determined that endangered
species in the vicinity of apple and pear orchards, alfalfa,
corn and cotton crops, could be placed at risk. Also, two
endangered insect species in the vicinity of food crop uses of
phosmet in certain counties of California could also be threatened
Therefore, labeling statements prohibiting the use of phosmet
in certain areas will be necessary.
2.3.2 ENVIRONMENTAL FATE AND GROUND WATER
Phosmet is not expected to be persistent in the environ-
ment because preliminary data indicates a relatively short
half-life (< 11 days). However, there are many data gaps in
the area of environmental fate which precludes a complete as-
sessment of the environmental fate for this chemical. Because
of its physical-chemical properties, there is the potential for
phosmet and possibly its degradates to contaminate ground water
in some soils. The Agency requested submission of basic ground
water data on June 29, 1984, under the ground water Data Call-in
notice. Several studies were submitted/referenced in response
to the call-in, but these data were not fully acceptable or in
all cases representative of the actual environmental conditions.
Thus, the Agency is requiring the full complement of basic
groundwater studies.
Preliminary data indicate several trends of phosmet behavior
in the environment. Radio-labeled phosmet degraded on irradiated
silica gel TLC plates, with a half-life of approximately 3-8
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days. Sterilization of loam and loamy sand soils increased
the half-lives to approximately 4.5 and 12.2 days respectively,
and drying the loam soil increased the half-life to approximately
19 days, indicating that microbial degradation is a factor in
the degradation of this compound. The major degradates observed
were phthalamide, N-methoxymethyl phthalimide, phthalic acid
and N-hydroxymethyl phthalamic acid. Phosmet appears to be
moderately mobile to immobile in soils ranging in texture from
sand to silty clay loam. Mobility in soils is inversely corre-
lated with organic matter content and soil pH. In the field
phosmet dissipated in sand and sandy loam soils with a half-life
of 1-11 days. To fully assess and complete the environmental
fate profile of phosmet, the Agency is requiring hydrolysis,
soil dissipation, anaerobic soil metabolism, leaching, photo-
degradation, rotational crop and re-entry data.
2.3.3 REPORTED PESTICIDE INCIDENTS
Under section 6{a)(2) of FIFRA a registrant is required
to submit adverse effects data to EPA. The Agency has reviewed
a summary of reports of adverse effects incidents (primarily
adverse animal reactions submitted by the registrant) regarding
the use of a phosmet flea and tick dip formulation (Paramite)
on dogs and cats. Although this product is sold primarily to
veterinarians, it is also available to homeowners through
veterinarians.
The summary report included 67 incidents involving this
product in the period June 1978 through September 21, 1979.
Of these 67 incidents, 39 involved cats only, 16 involved dogs
only, 2 involved cats and dogs, 8 involved human reactions,
and 2 involved dogs and human reactions. Reported mortalities
from these incidents were 20 cats (one leukemic) and 12 dogs.
In 1979, in response to reports of adverse reactions
and deaths to house cats from the use of this product in the
Austin, Texas area, the Agency conducted a survey of veteri-
narians in that area. Veterinarians were contacted by the
Texas Epidemiological Studies Program, Texas Tech University
School of Medicine, to ascertain their experiences or awareness
of problems involving Paramite on pets. Out of 14 veterinarians
contacted, 8 reported problems, 5 experienced no difficulty
with its use, and 1 did not use Paramite. Several expressed
the opinion that the material is probably not being used properly
in those cases where problems occur. Since the summary report
and telephone survey in 1979, the Agency has received additional
complaints from pet owners regarding adverse reactions on pets.
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2.4 TOLERANCE REASSESSMENT
Tolerances have been established on a number of raw
agricultural commodities and in meat, fat and meat byproducts
(40 CFR 180.261) and in processed food (21 CFR 193.279) for
phosmet and its oxygen analog at levels ranging from 0-1 to
40.0 ppm. A listing of the established tolerances is located
at the end of this section.
The Agency has evaluated the residue and toxicology
data supporting these tolerances and reviewed all uses of
phosmet. Based on the available data the Agency has reached
the following conclusions:
2.4.1 RESIDUE DATA
EPA has evaluated the residue data supporting the existing
tolerances and has determined that the metabolism of phosmet
in plants and animals is not adequately understood and that
residue data on certain crops are inadequate.
Below is a brief summary outlining the acceptable residue
data supporting established tolerances, additional data necessary
to reassess tolerances, and revisions necessary in the current
tolerance expressions for certain commodities. It should be noted
that the adequacy of established tolerances may change after
information on the nature of the residues in plants and animals
is submitted and evaluated.
o Sufficient data are available to ascertain the adequacy
of established tolerances for residues of phosmet in or on
tomatoes, pears, apples, peaches, cherries, blueberries,
cranberries, almond hulls, sweet corn (kernels plus cob with
husks removed), field corn, corn forage and fodder, alfalfa,
cottonseed and kiwi. Insufficient crop data are available
to ascertain the adequacy of the established tolerances for
residues in or on potatoes, peas, pea forage, pea hay, citrus
fruits, apricots, nectarines, plums, tree nuts, and cottonseed
oil. The tolerance for residues in or on sweet potatoes must
be revised.
o Tolerances for residues in animal commodities cannot be
assessed at this time until the required animal metabolism
studies and all studies regarding the magnitude of residues in
or on feed items have been submitted and reviewed.
o Processing studies are required for potatoes, apples, plums,
peaches, grapes, field corn grain, and cottonseed. Data on
the fate of residues after cooking and washing of apples and
peaches must also be submitted.
o In addition to the conclusions stated above regarding
the adequacy of established tolerances, the Agency has made
the following administrative determinations: a) the tolerance
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definition for "cherries" will be amended to "cherries sour";
(b) the tolerance definition for "alfalfa" will be changed to
"alfalfa hay and forage"; (c) a food additive tolerance must
be proposed for residues in citrus oil since data indicate
that residues may concentrate up to 4X after processing
(this tolerance proposal is contingent upon the final onco-
genicity classification for phosmet - see footnote page 33).
(d) the tolerance for residues in or on alfalfa forage will
be reduced from 40 to 20 ppm since residue data indicate 20 ppm
is adequate (the tolerance for residues in or on hay should
remain at 40 ppm); (e) a crop group tolerance of 10 ppm may
be proposed for residues in or on members of the pome fruits
group; and (f) the established tolerance for residues in or
on cranberries will be revoked because there are currently
no registered uses for this crop.
2.4.2 TOXICOLOGY DATA AND ACCEPTABLE DAILY INTAKE (ADI)
The toxicology data base considered in support of
the tolerances and the ADI includes:
STUDY TYPE
RESULT
2-Year Chronic Feeding/rat
2-Year Chronic Feeding/dog
3-Generation Reproduction/rat
Teratology Study/rabbit
Teratology Study/monkey
Systemic NOEL = 40 ppm
Cholinesterase NOEL = 40 ppm
NOEL = 80 ppm
Negative @ 60 mg/kg/day
Negative @ 8 mg/kg/day
Refer to section 2.2 for specific details regarding these studies.
The Acceptable Daily Intake (ADI) and the Maximum Per-
missible Intake (MPI) are two ways of expressing the amount of
substance that the Agency believes, on the basis of the results
of data from animal studies and the application of "safety" or
"uncertainty" factors, may safely be ingested by humans without
risk of non-oncogenic adverse health effects. The ADI is
expressed in terms of milligrams (mg) of the substance per
kilogram (kg) of body weight per day (mg/kg/day). The MPI, a
related figure, is obtained by assuming a human body weight of
60 kg, and is expressed in terms of mg of substance per day
(mg/day). It was determined that the rat is the most sensitive
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species to phosmet. Therefore the ADI for humans was based
on the 2-year chronic feeding study in rats. The ADI in humans
was calculated to be 0.02 mg/kg/day and the maximum permitted
intake (MPI) equal to 1.2 mg/day with a NOEL of 40 ppm and
a safety factor of 100.
This ADI represents a revision to the previously calculated
ADI that was set using the 2-year dog feeding study with a NOEL
of 40 ppm. The NOEL on the dog study was based on cholinesterase
inhibition. A tenfold safety factor was used to arrive at an
ADI of 0.10 mg/kg/day and an MPI of 6 mg/kg for a 60 kg human.
However, according to current policy a safety factor of 10
should only be employed for cholinesterase inhibiting pesti-
cides when there is an "... adequate spread between the
NOEL for cholinesterase inhibition and the NOEL for any other
significant effect observed." In the 2-year feeding study in
rats, the NOEL for systemic effects was 40 ppm, identical to
the NOEL for cholinesterase inhibition. The systemic effects
observed were a slight decrement in body weight gain and moderate
liver cell vacuolation in males. These are significant effects;
therefore, in order to provide a sufficient safety factor for
these effects, the original ADI was decreased by a factor of 5
in order to equate to the use of a hundredfold safety factor
with the rat NOEL of 40 ppm.
Since the ADI is now set on a systemic effects for life-
time exposure with a safety factor of 100 rather than on
cholinesterase inhibition, the tolerance expression under
40 CFR 180.261 will be amended by deleting the reference to
'"cholinesterase-inhibiting" residues.
The theoretical maximum residue contribution (TMRC) is the
theoretically maximum amount of residues of a pesticide that
might be present in the human diet, based on assumptions the
Agency makes about the average human daily intake of foods con-
taining residues at the level of the established tolerances.
The TMRC to the human diet from existing tolerances for phosmet
is 1.0932 mg/day (in a 1.5 kg diet). The TMRC is equivalent
to 98.29% of the ADI employing the United States Department of
Agriculture food factors. Since virtually all of the ADI has
been used up by the TMRC and the Agency is aware of a potential
oncogenic response to phosmet, new tolerances and/or new uses
will not be approved if they contribute significantly to the
TMRC and/or result in a significant increase in the dietary
exposure.
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Sununary of Tolerances Issued for Phosmet
Tolerances (ppm)
(MRL)
Commodity United States1/
Alfalfa
Almonds, hulls
Apples
Apricots
Blueberries
Cattle, fat
Cattle, meat
Cattle, mby
Cherries
Citrus fruits
Corn, fresh (including
sweet K + 6 WHR)
Corn, fodder
Corn, forage
Corn, grain
Cottonseed
Cranberries
Goats, fat
Goats, mbyp
Goat, meat
Grapes
Hogs, fat
Hogs , mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Kiwi fruit
Nectarines
Nuts
Peaches
Pears
Peas
Peas, forage
Peas, hay
Plums (fresh prunes)
Potatoes
Sheep, fat
Sheep, mbyp
Sheep, meat
Sweet potatoes
Tomatoes
Cottonseed oil
40.0
10.0
10.0
5.0
10.0
0.2
0.2
0.2
10.0
5.0
0.5
10.0
10.0
0.5
0.1
10.0
0.2
0.2
0.2
10.0
0.2
0.2
0.2
0.2
0.2
0.2
25.0
5.0
0.1 (N)
10.0
10.0
0.5
10.0
10.0
5.0
0.1
0.2
0.2
0.2
10.0
2.0
0.2
Canada^/ Mexico^5/ International (Codex!
0.1 (N)
— —
10.0
— —
5.0
0.1 (N)
0.1 (N)
0.1 (N)
7.0
— —
— —
— —
— —
— —
— —
— —
—
— —
—
10.0
0.1 (N)
0.1 (N)
0.1 (N)
— —
—
—
1.0
— —
— —
10.0
10.0
— —
—
--
5.0
0.1 (N)
— —
— —
— —
— —
—
— —
20.0
—
10.0
5.0
10.0
1.0
1.0
1.0
—
5.0
0.2
—
—
—
—
--
--
—
—
—
—
—
—
—
—
—
15.0
5.0
0.1
10.0
10.0
0.1
—
__
__
0.5
_ _
—
__
10.0
—
residues of phosmet and its oxygen analog.
2/ Canadian tolerances are expressed in terms of residues of phosmet
~ Per se.
3/ There are no Mexican tolerances established for phosmet.
N - negligible; tolerances are set at the limit of detection.
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3. REGULATORY POSITIONS AND RATIONALES
3.1 SUMMARY OF REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on phosmet the Agency has made the
following determinations:
1. Special Review; None of the risk criteria listed in
40 CFR 154.7 have been exceeded for phosmet. Therefore,
no referral to Special Review is being made at this time.
Rationale (Humans); The data presently available for
phosmet provide only limited evidence for oncogenicity
in animals at this time. The two-year mouse study
indicated phosmet produced an increased incidence of
liver tumors only at the highest dose tested in males,
and trends for liver tumors in females, in only one
strain and species of mice and in only one experiment.
In addition, phosmet was essentially non-mutagenic
(in a limited and inadequate battery of tests) and no
positive correlations with respect to oncogenicity and
mutagenicity could be made with known structural analogues.
After the two-year rat oncogenicity and additional muta-
genicity studies are submitted and evaluated, the Agency
will reassess the oncogenicity issue and determine if
dietary and worker carcinogenicity risk assessments are
necessary.
Rationale (Non-Target Organisms): The available labora-
tory data indicates that phosmet is very highly toxic to
fish. Terrestrial residue analysis and aquatic runoff
modeling further indicate that certain use patterns of
phosmet could result in exposure of certain aquatic
organisms (including endangered species) to potentially
hazardous levels of the pesticide. The Agency has not
received any reports on fish kills associated with the
use of phosmet during its use history. Additional data
are needed before the Agency can complete a full assess-
ment of this hazard potential. After the evaluation of
required environmental fate data, chronic fish and
aquatic invertebrate data, and residue field studies,
the Agency will determine if it should initiate a public
interim review process by placing the chemical in Special
Review.
2. Tolerance Reassessment; The Agency will reassess the adequacy
of the existing tolerances after required metabolism data and
residue data have been submitted.
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Rationale; Data gaps exist for plant and animal metabolism,
storage stability, magnitude of the residues in several raw
agricultural commodities and processed food and feed items.
Upon receipt of the data required in Table A, the Agency's
conclusions with regard to the adequacy of established
tolerances are subject to change. Since the data required
for individual commodities are dependent on the metabolism
data, the metabolism data will be obtained and reviewed prior
to any required residue data.
3. New Tolerances/New Uses; New tolerances and uses will be
issued only on a case-by-case basis after considering
the effects on the theoretical maximum residue concentrations
(TMRC), the maximum permitted intake (MPI), and the oncogenic
risks.
Rationale; Available residue data, including processing
data and metabolism data, are insufficient and/or lack-
ing. This lack of data prohibits the Agency from conduct-
ing a full tolerance reassessment. The Agency is also
concerned that virtually all of the ADI has been used up
by the TMRC based upon existing tolerances. The data from
the mouse oncogenicity results indicating oncogenic response
has generated additional concerns. Therefore careful con-
sideration will be given to the increase in dietary
exposure before approving new tolerances/uses.
4. Tolerance expression; The tolerance expression for phosmet
under 40 CFR 180.261 will be amended by deleting the re-
ference to "cholinesterase inhibiting" residues.
Rationale; The ADI is now set on systemic effects for
lifetime exposure rather than on cholinesterase inhibition.
5. Endangered Species Concerns; The Agency has determined that
endangered specieslabel restrictions are necessary precaution
during the time that environmental data required by this
Standard is generated and analyzed. The Agency is requiring
endangered species labeling for all end-use products intended
for use on apples, pears, alfalfa, corn, and cotton to
protect certain threatened aquatic species, and for all
end-use protects intended for terrestrial food crop use
in certain counties in California to protect the elderberry
longhorn beetle and the Delta green ground beetle. Labeling
statements will require users to obtain and review a bulletin
on use in areas where these aquatic species and insects
are found and in those areas not to use phosmet. The
Agency intends to formally consult with the Office of
Endangered Species (OES), U.S. Department of Interior
(USDI), and request a biological opinion on the potential
of phosmet use to jeopardize endangered species. To further
evaluate the hazard to aquatic organisms, including endangered
species, the Agency is requiring aquatic field monitoring
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-31-
data to assess the levels of phosmet entering the aquatic
ecosystems from phosmet use on apple orchards, corn, cotton,
and alfalfa crops. (Refer to Section 3.4 for labeling
requirements)
Rationale: The required labeling restrictions are based
upon the high toxicity of phosmet to aquatic organisms and
the potential toxicity to these endangered species from
specific terrestrial crop applications with a potential
for aquatic contamination. Based upon maximum use rates
of phosmet on apple orchards, corn, cotton and alfalfa
fields, the Agency estimated the environmental concentration
of phosmet in water from spray drift and runoff, to equal
or exceed the LC5Q for certain aquatic species. This
indicates that phosmet use may affect endangered species;
therefore endangered species labeling are required.
6. Restricted Use (Aquatic); The Agency will not restrict
certain uses of phosmet to certified applicators at this
time but has determined that precautionary labeling for
aquatic organisms is required. (Refer to Section 3.4 for
labeling requirements).
Rationale; The required labeling restrictions are
based on the high toxicity of phosmet to aquatic
organisms. Available data indicate that phosmet is
highly toxic to fish and aquatic invertebrates (in-
cluding freshwater and estuarine organisms). Analysis
of terrestrial residue and aquatic runoff modeling
(theoretical calculation) indicate that certain use
patterns of phosmet could results in a hazard to aquatic
organisms; however, the Agency has not received any reports
on fish kills following phosmet application during its
long use history. Fish, invertebrate, estuarine/marine
organisms and field monitoring data, plus environmental
fate data are required to complete the hazard assessment
for aquatLc organisms. Should additional data demonstrate
that phosmet poses risks to aquatic organisms that could
be mitigated by increased controls in application, restricted
use classification may be required.
7. Reentry Requirements; The Agency is imposing an interim
24-hour reentry interval. (Refer to section 3.4 for
labeling requirements.)
Rationale; Reentry data are required by 40 CFR 158.140
for pesticides which have use patterns likely to result
in high dermal and/or inhalation exposure to persons
entering pesticide treated fields. Phosmet is registered
for agricultural uses that could involve substantial
prolonged human exposure to the residues on foliage.
There are not sufficient data available for the Agency
to determine the extent of protection necessary to minimize
exposure to farmworkers and others who enter fields sub-
sequent to phosmet application. The crops for which foliar
dissipation data are required are those whose propagation
requires human tasks that involve substantial, prolonged
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-32-
dermal contact with pesticide treated surfaces following
foliar application of phosmet. Data to address this
concern are lacking and have been requested under the
February 28, 1985, Reentry Data Call-in Notice for phosmet.
This data is due by December 1986. Until the required
data are submitted and evaluated, an interim 24-hour reentry
interval is being required to lessen exposure to workers
entering treated fields. End-use products with directions
for use on such crops must include the label statements
required under PR Notices 83-2 and 84-1. A 24-hour reentry
interval must be included in the required written or oral
warnings given to farmworkers.
8. Protective Clothing Requirement; The Agency has deter-
mined that protective clothing be worn by mixer/loaders
and applicators. Product labels will be required to specify
that mixer/loaders wear mid-forearm to elbow length
chemical resistant gloves, a long sleeve shirt, and long
pants. Labels will require applicators to wear a long
sleeve shirt and long pants and a wide-brimmed chemical
resistant hat during upward directed foliar spraying to
fruit and nut crops. The Agency will also require that a
special glove permeability study be conducted. (Refer to
Section 3.4 for labeling requirements.)
Rationale; Phosmet is a typical organophosphate chemical
that can induce cholinesterase inhibition upon repeated
significant exposure. Protective clothing is necessary to
lessen exposure to workers and to protect against acute
toxicity and potential oncogenic risk during mixing, load-
ing and application of phosmet. The glove permeability
study will permit the Agency to evaluate dermal exposure
and risks with protective clothing.
9. Adverse Reactions In Pets; The Agency will analyze the
safety and efficacy data of a phosmet flea dip formulation
(Paramite) to determine if further regulatory action is
warranted. A warning statement indicating that improper
dilution of the product could cause serious injury to pets
is also being required during the interim. (Refer to Section
3.4 for labeling requirements).
Rationale: Complaints of animal poisoning incidents have
been received relating to the use of phosmet. It has been
alleged that phosmet causes illness and death in dogs and
cats. It is uncertain if these incidents were due to
misuse, animal stress (heat, exercise), or age or type of
dog and cat treated. As with other organophosphates,
phosmet can inhibit plasma and erythrocyte cholinesterase
activity in animals. Since there is a history of com-
plaints and reactions associated with the use of this
product on animals, existing data submittel in support of
this product's use on pets will be analyzed to determine
if the minimum effective rate is being recommended and if
it demonstrates an adequate safety margin to animals over its
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-33-
use level. If the data do not demonstrate an adequate
margin of safety to animals when used as directed, further
regulatory actions may be warranted, including labeling
direction changes, use restrictions or cancellation.
10. Cranberries; The Agency has determined that the tolerance
for cranberries should be revoked because there are no
registered uses for phosmet on cranberries. The Agency
cannot evaluate the adequacy of the tolerance on
unspecified directions for use.
Rationale; A tolerance of 10 ppm was established for
combined residues of phosmet and its oxygen analog in
or on cranberries based upon use directions proposed in
1974. Currently there are no registered uses for phosmet
on cranberries.
11. Processing data; The Agency is requiring processing data
for the following raw agricultural commodities: potatoes,
apples, plums, peaches, grapes, field corn grain, and
cottonseed.
Rationale; There are no data and/or insufficient data to
determine whether residues of phosmet concentrate when these
commodities are processed into food or feed items.*
12. Rotational Crop Label Restrictions; The Agency is not
requiring a rotational crop restriction. If required
data demonstrate that follow-up crops take up phosmet resi-
dues from soil, rotational crop restrictions or tolerances
in those unregistered crops may be necessary-
Rationale; The Agency lacks appropriate rotational crop
data at the present time to determine whether planting
food or feed crops in phosmet-treated soils would result in
illegal residues in these crops. Several factors lead the
Agency to believe that rotational crop restrictions are not
necessary to prevent illegal residues: (1) Preliminary data
indicates that the half-life of phosmet is _<^ 11 days.
Degradation in soil is primarily through hydrolysis.
Soil microorganisms and photodegradation accelerates the
process. Potatoes receive the highest application rate of
phosmet near the time of harvest. Since the tolerance for
phosmet is at or near the level of detection, this fact
suggests that plant uptake may be negligible.
*The Delaney Clause in section 409 of the Federal Food, Drug
and Cosmetic Act bars the establishment of food active regula-
tions for substances which induce cancer in man or test animals.
Phosmet has been found to produce an oncogenic response in
test animals. The Agency will be soliciting comments on Delaney
Clause issues regarding pesticides which have produced positive
oncogenic responses in chronic animal studies. This notice is
scheduled for issuance before the end of 1986.
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13. Groundwater Concerns; The Agency is not imposing a ground-
water advisory statement on phosmet labeling at this time.
Rationale; The Agency issued a grbundwater Data Call-in
(DCI) notice on June 29, 1984. The registrant cited five
studies in response to the DCI. None of the studies satis-
fied the data requirements. Since they were not conducted
in accordance with current testing guidelines, additional
data must be submitted to the Agency to satisfy these
requirements. To date, the Agency is not aware of incidents
where phosmet has contaminated groundwater. After review
of the requested data, the Agency will take appropriate
steps to protect groundwater if necessary.
14. Continuation of Registration; While data gaps are being
filled, currently registered end-use products containing
phosmet as the sole active ingredient may be sold, distri-
buted and used, subject to 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 does not normally cancel
or withhold registration simply because data are missing or
inadequate (see FIFRA section 3(c)(2)(B) and section 3(c)(7)),
unless available data indicate that use of the product is
likely to cause unreasonable adverse effects on the
environment.
Issuance of this Standard provides a mechanism for identify-
ing data needs. After receipt and review of the data the
Agency will determine if additional regulatory changes are
necessary.
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3.2 CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain phosmet as the sole active ingredient,
(solvents or diluents should be declared as inert) bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in this
section.
3.3 ACCEPTABLE RANGES AND LIMITS
3.3.1 PRODUCT COMPOSITION STANDARD
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain phosmet as the
sole active ingredient. Each MP formulation proposed for
registration must be fully described with an appropriate certi-
fication of limits, stating maximum and minimum amounts of the
active ingredient and inert ingredients which are present in
products, as well as impurities found at greater than 0.1%.
3.3.2 ACUTE TOXICITY LIMITS
The Agency will consider registration of technical grade
and MPs containing phosmet provided that the product labeling
bears appropriate precautionary statements for the acute
toxicity category in which each product is placed.
3.3.3 USE PATTERNS
To be registered under this Standard, MPs may be labeled
for formulation into end-use products (EPs) only for the
commodities listed below.
TERRESTRIAL FOOD CROP
(Agricultural CropsT
Alfalfa Lemon
Almond Nectarines
Apple Orange
Apricot Peach
Blueberry Pear
Cherry, Sour (Tart) Peas
Citrus Fruits Pecan
Corn Plum
Cotton Potato
Grapes Prune
Kiwi Fruit
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TERRESTRIAL NON-FOOD CROPS
(Ornamental Plants)
Christmas Tree Plantations
Loblolly Pine (seedlings)
Ornamental Shrubs
Ornamental and/or Shade Trees
Slash Pine (seedlings)
Western Pines
White Pines (seedlings)
(Non-Crop, Wide Area, and General Indoor/Outdoor Treatments)
Wide Area and General Outdoor Treatments
Limited to Fire Ant Control
DOhESTIC OUTDOOR
(Ornamental Plants)
Domestic Dwellings, Outdoor
INDOOR
(Agricultural Crops)
Sweet potato
(Pets and Domestic Animals)
(Animals and Their Man-Made Premises)
Beef Cattle
Dogs/Cats
Swine
The Use Index lists all registered uses, as well as
approved maximum application rates and frequencies.
3.4 REQUIRED LABELING
All MPs (and EPs if covered by Standard) must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix
II and the section below contains information on label require-
ments .
No product containing phosraet as a ingredient may be
released for shipment by the registrant after one year of
receipt of this Standard unless the product bears an amended
label which complies with the requirements of this Standard.
No product containing phosmet as an active ingredient may
be distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so received)
delivered or offered to be delivered by any person after twenty
four months from issuance of the Standard unless the product
bears an amended label which complies with the requirements of
this Standard.
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Th e following information must appear on the labeling:
3,4.1. Ingredients Statement
The ingredient statement for MPs must list the active
ingredient as:
N- (Me reap tome thy 1 )phthalimlde S-(O, O-dimethy 1 phoaphorod i. frhloate)
3.4.2. Use Pattern Statements
All MPs must state that they are intended for formulation
into end-use products for acceptable use patterns. Labeling
must specify sites, which are listed in Use Patterns, Section
3.3.3. However, no use may be included on the label where
the registrant fai l.s to comply with the data requirements i n
Table A for that use pattern.
3.4.3 Precautionary Statements
Manufacturing Use Products (MP)
1. Labels for MPs must bear the following statements under
the heading "Environmental Hazards."
This pesticide is extremely toxic to fish. Do not
discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public waters unless
this product is specifically identified and addressed in
an NPDES permit. Do not discharge effluent containing
this product into sewer systems without previously notifying
the sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office of the
EPA.
2. All MPs must bear the following protective clothing state-
ment .
When mixing/loading or otherwise handling the concentrate,
wear mid forearm to elbow length chemical resistant gloves,
long sleeve shirt, and long pants.
3. The directions for use must include the following statement:
Formulators using this product are responsible for EPA
registrations for their formulated product(s).
End-Use Products (EP)
1. All EPs for terrestrial food and non-food use and domestic
outdoor uses must bear the following statements under the
heading "Environmental Hazards";
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This pesticide is extremely toxic to fish. Do not
apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water
by cleaning of equipment or disposal of wastes.
Drift or runoff from treated areas may be hazardous
to aquatic organisms in neighboring areas.
This product is highly toxic to bees exposed to direct
treatment on blooming crops or weeds. Do not apply
this product or allow it to drift to blooming crops
while bees are actively visiting the treatment areas.
2. All EPs intended for use on apples, pears, alfalfa,
corn, cotton and for terrestrial food uses in
California must bear the following endangered species
labeling:
The use of any pesticide in a manner that may kill
or otherwise harm an endangered or threatened species
or adversely modify their habitat is a violation of
federal laws. The use of this product is controlled
to prevent death or harm to endangered or threatened
species that occur in the following counties or else-
where in their range.
Before using this pesticide in the following counties
you must obtain the EPA Cropland Endangered Species
Bulletin. The use of this pesticide is prohibited in
these counties unless specified otherwise in the Bulletin,
The EPA Bulletin is available from either your County
Agricultural Extension Agent, the Endangered Species
Specialist in your State Wildife Agency Headquarters or
the appropriate Regional Office of either the U.S. Fish
and Wildlife Service (FWS) or the U.S. Environmental
Protection Agency. THIS BULLETIN MUST BE REVIEWED
PRIOR TO PESTICIDE
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STATE (Regional office FWS)
Species
ALABAMA (Atlanta, GA.)
Slackwater darter
Alabama cave fish
Freshwater mussels
ARIZONA (Albuquerque, N.M.)
Woundf in
Gila toprainnow
ARKANSAS (Atlanta, GA.)
Freshwater mussels
Leopard darter
CALIFORNIA (Portland, OR.)
Lahontan cutthroat trout
Unarmored threespine
stickleback
COLORADO (Denver. CO.)
Colorado squawfish
KENTUCKY (Atlanta, GA.)
Freshwater mussels
MISSISSIPPI (Atlanta, GA.)
Bayou darter
NEVADA
Moapa dace
Woundf in
Pahranagat
Cui-ui
COUNTY
LAUDERDALE
LIMESTONE
MADISON
LAUDERDALE
COLBERT
JACKSON
MOHAVE
GRAHAM
CLAY
CLARK
CROSS
LAWRENCE
MARSHALL
MORGAN
SANTA CRUZ
RANDOLPH
SHARP
ST. FRANCIS
SEVIER
ALPINE
NEVADA
SIERRA
LOS ANGELES
BLANCO
DELTA
GARFIELD
MESA
BALLARD
EDMUNDSON
JACKSON
LAUREL
MARSHALL
MONO
PLACER
SANTA BARBARA
MOFFAT
RIO
ROUTT
McCRACKEN
PULASKI
ROCKCASTLE
WARREN
WAYNE
COPIA
CLARK
CLARK
LINCOLN
WAS HOE
Pahrump killifish CLARK
WHITE PINE
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-40-
STATE (Regional office FWS)
Species
NEW MEXICO (Albuquerque, N.M.)
Pecos gambusia
OHIO (Twin Cities, MN.)
Scioto madtom
OKLAHOMA (Albuquerque, N.M.)
Leopard darter
TENNESSEE (Atlanta, GA.)
Slackwater darter
Freshwater mussels
TEXAS (Albuquerque, N.M.)
Conunanche Springs
pupfish
Pecos gambusia
San Marcos gambusia
Houston Toad
Fountain darter
UTAH (Denver, CO.)
Woundfin
Colorado squawfish
VIRGINIA (Newton Corners, MA.)
Freshwater mussels
CALIFORNIA (Portland, OR)
Valley elderberry longhorn
beetle
Delta green ground beetle
COUNTY
CHAVES
EDDY
CHAMPAGNE
FRANKLIN
LOGAN
MADISON
PICKAWAY
UNION
LEFLORE
McCURTAIN
LAWRENCE
WAYNE
BLOUNT
CLAI BORNE
DECATUR
FRANKLIN
HANCOCK
HARD IN
LINCOLN
LOUDON
MARSHALL
MAURY
RHEA
ROANE
SCOTT
SEQUATCHIE
SMITH
SULLIVAN
JEFF DAVIS
REEVES
JEFF DAVIS
PECOS
HAYS
BASTROP
HAYS
REEVES
BURLESON
WASHINGTON
CARBON
DUCHESNE
EMERY
GARFIELD
GRAND
LEE
RUSSELL
SCOTT
SMYTH
SACRAMENTO
KANE
SAN JUAN
UINTAH
WAYNE
TAZEWELL
WASHINGTON
WISE
MERCED
SOLANO
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-41-
3. The following worker reentry statement must be added
to the labeling for products with directions for use on
crops whose culture requires hand labor:
Do not allow worker reentry into treated fields within
24 hours of application unless appropriate protective
clothing is worn. Protective clothing means, at least,
a hat or other suitable head covering, a long sleeved
shirt and long legged trouses or a coverall type garment
(all closely woven fabric covering the body, including
the arms and legs) shoes and socks.
4. Products with directions for use on terrestrial food and
non-food crops and domestic outdoor uses must bear the
following protective clothing statement:
When mixing/loading wear mid forearm to elbow length
chemical resistant gloves, long sleeve shirt, and long
pants. During the application wear long sleeve shirt
and long pants. Applicator must also wear a wide-
brimmed chemical resistant hat while spraying up toward
fruit and nut crops.
Any article of clothing worn while applying product
must be cleaned before re-using. Clothing should
be laundered separately from household articles.
Clothing which has been drenched or has otherwise
absorbed concentrated pesticide must be disposed
of in a sanitary landfill, incinerated, or
burned if allowed by state and local authorities.
5. Products with directions for use as livestock sprays,
livestock dips, and dog and cat dips, must bear the
following protective clothing statement:
Applicators must wear long sleeved shirt, long pants,
elbow length waterproof gloves, waterproof apron,
and unlined waterproof boots.
6. Products with directions for use as a dog or cat dip
must bear the following precautions:
Improper dilution of this product could cause serious
injury to your dog and/or cat.
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4. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in section 1.1 are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end-use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
4.1 MANUFACTURING-USE PRODUCTS
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 sections 3.3 and 3.4 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 sections 3.3 and 3.4.
4. Administrative requirements (application forms, Confiden-
tial Statements of Formula, data compensation provisions)
associated with reregistration.
1 Data requirements are listed in the three Tables in Appendix
1 of this Registration Standard. The Guide to the 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 Registration
Standard.
Table B lists product-specific data applicable to manufactur-
ing-use products. The data in Tables A and B need not be
submitted by a producer who is eligible for the formulator's
exemption of 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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Manufacturlng^use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
4.2 END-USE PRODUCTS
End-use products containing this pesticide as the
sole active ingredient*are subject tol
1 . The restrictions (if any) upon use, composition, or
packaging listed in sections 3.3 and 3.4 if they pertain
to the end-use product.
2. If eligible for the formulator's exemption2, 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 3.4.
solvents or diluents must be declared as inerts. The
Agency does not have data indicating that these solvents
are insecticidal.
End-use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption, the
date requirements listed in Tables A and C.
2 If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you
are eligible for the formulator's exemption for generic data
concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing-use product
you purchase (Table B).
Two circumstances nullify this exemption:
(1) If you change sources of active ingredient to an
unregistered product, formulate your own active
ingredient, or acquire your active ingredient from
a firm with ownership in common with yours, you
lose the exemption and become subject to the data
requirements in Table A.
(2) If no producer subject to the generic data require-
ments in Table A agrees to submit the required data,
all end-use producers lose the exemption, and become
subiect to those data requirements. EPA will inform
you if this occurs.
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2. If eligible for the formulator's exemption, the data
requirements listed in Table C.
5. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA section 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.3
5.1 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.
5.2 WHO MUST SUBMIT GENERIC DATA?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA section
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the forraulator's
exemption (FIFRA section 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 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
3 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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this aetivt ingetdttnt afttr fch§ t§suane§ of this
Standard, you will bt rtquirtd to submit ©r cite
dttt rtlivant to the us§§ of your product if, at thi time
the application is submitted, thi data have b@tn submitted
to the Ageney by currant rtgistrants. If the requirtd 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 section 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 section 6(e)).
5.3 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.
5.4 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.
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.
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-46-
3. You have attempted to enter into an agreement to jointly
develop clata^ but no other registrant has°accepted your ofter.
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:
(a) 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).
(b) 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:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA section
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.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not(or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
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-47-
5. You request that EPA amend your registration by deleting
the uses for which the data are needecfTYou 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.~~
5.5 PROCEDURES FOR REQUESTING A CHANGE IN TESTING PROTOCOL.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either 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
and await EPA approval, 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.
5.6 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
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 before the deadline for response. Once dates
have been committed to and EPA has accepted these commit-
ments, any subsequent requests for a time extension must
be submitted in writing to the Office of Compliance
Monitoring.
EPA will view failure to request an extension before
the 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. Time extensions
may be considered when ioint data development is planned,
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-48-
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not extend the tlmefrarae
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.
5.7 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 section 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
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 consistent
with the provisions of FIFRA.
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h. RKIJI1I KK.MKNT R)R SUHMISSION OK PRODUCT-SPF-CIK! C DATA
Under Its HCI authority, KPA h;i« del crrn I ned f.hal certain
produc t ~npee I I I e data art* required lo ma I n I n I n your rey I « t; ra t i onn
In effect. Prodtic t -.-ipoe i f i c data i\fi» derived f: roin lent I tip1.
UN I up, n N pec I tl c I o fim 1 1 i\ {' ed product, and , i in I I If n generic
dala. p.enerally support on I y I he r<'x, I H I rat Ion of Ihal produri, .
All Htich d.-iI'M iniiHl !)<• HuhinilliMl by thr ilftlr. <*n fip«'c I f I <-d In
Mils Ri'p.lsl r.-il ion S
IK you h.'iv«' ;i in.inn I ac f nr 1 u>;-\ifi«' prodnci , thcne data /ir<-
II. sled In Table H. II you li/ivc nn cnd-u.'ii' pfoducl;, (be d;tl(i
,inv llHtcd In Table (I. As nol r/pni:y h«n
iliH- i dcd I ba t It will no I routinely requ I re p roduc. r - nper | f | r
data tor end-tine product n at I li i n l.lm**. TherelOre, Tabl«» ('.
may not be contained in I bin Ke^ i s t ra I. I on Standard; if tbere
is no Table (! , yon are not required lo submit I be data at
Ibis (I UK* .
In order lo comply with I IIP product npeclflc dnta refjulro-
mrnt's, you iniiHl l:o I low I'be naine procedure*! HH for generic dat.a.
(Sec HecMoiiH ')./», "~> . *i , "> . 6 . and '>./.) Yf)n Hbould riof.e, howf-vr
tliMl: product chfin I M(. ry data are required Tor cvfry product., «nd
fbe only acceprable re.sponne.s are o|>rlons I (.submit: dal:«) or 6
(cancellation of7 rep, i« t; rat: ion) , llsl.ed under HPction ^.4.
Failure to comply with tbe product. -H pec I f Ic dat.a require-
ments for your products will result in suspension of the
product's registration.
7. RKQUIRKMKNT KOR SUBMISSION OF RKVLSKD LAHKI.I MG
FT. FRA requires eacb product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in section 3.4 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 3.4. EPA may issue a "Notice of Intent to Cancel"
the registration of your product under FIFRA section 6(b)(1).
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-50-
8. INSTRUCTIONS FOR SUBMISSION
8.1 MANUFACTURING-USE PRODUCTS
For manufacturing products (MUPs) containing phosmet as
the 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 . 4-
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ).
d. Evidence of compliance with data compensation
requirements of FIFRA section 3(c)(1)(D). Refer to
40 CFR 152.80-152.99.
2. Within 9 months from receipt of this document you must
submTtto the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1) .
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication of
the front panel of the label, and the intended type sizes
of the text.
d. Product Specific Data Report (EPA Form 8580-4).
4 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 )
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-51-
3. Within the times set forth injlabjle _A, you must submit
to tKe Registration Division "a~n~gerTerrrc'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.
For manufacturing-use products containing phosmet in
combination with other active ingredients(other than solvents)*.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
a. F1FRA 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.
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.
8.2 For end-use products containing phosmet 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 attachments4- (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4), if
Table C lists required product-specific data.
* Solvents or diluents such as petroleum distillates must be
declared as inerts.
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-52-
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 3 (Regulatory Position and
Rationale).
8.3 INTRASTATE PRODUCTS
Intrastate products containing phosmet either as the
sole active ingredient or in combination with othef~
active ingredients.
These products are being called in for full Federal
registration. Producers of these products are being
sent a letter instructing them how to submit an
application for registration.
8.4 ADDRESSES
The required information must be submitted to the following
address:
George T. LaRocca
Product Manager 15
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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I. DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply 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
listeHTnthe 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
Any other designations will be defined in a footnote to the table
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TGUIDE-2
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 datainitsfiles, 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 issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
Data Requirement Conposition
§158.120 Product Chemistry
Product Identity and Conposition:
61-1 - Product Identity and Disclosure
of Ingredients TGAI
61-2 - Description of Beginning Ma-
terials and Manufacturing
Process TGAI
61-3 - Discussion of Formation of
Impurities TGAI
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples TGAI
62-2 - Certification of Ingredient
Limits TGAI
62-3 - Analytical Methods to Verify
Certified Limits TGAI
Physical and Chemical Characteristics 9/
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
Must Additional
Use Does EPA Bibliographic Data be
Pattern Have Data? Citation Submitted
A,B,H,I Partially — 2/ Yes 3/
A,B,H,I No — Yes */
A,B,H,I No — Yes £/
A,B,H,I No — - Yes £/
A,B,H,I No —• Yes ]_/
A,B,H,I Partially 00112317, 00112263 Yes 8/
00126567, 00112314
A,B,H,I No — Yes
A,B,H,I No — Yes
A,B,H,I No — Yes
Timeframe
For Data
submission^
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
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TABLE A
GENERIC DATA REQUIREMENTS FDR PHDSMET
Data Requirement
Composition
Use
Pattern
Does EPA
Have Data?
Must Additional
Bibliographic Data be
Citation Submitted
Time frame
For Data
Submission^
§158.120 Product Chemistry (continued)
Physical and Chemical Composition
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-1 1 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
(continued)
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
A,B,H,I
A.B.H.I
A.B.H.I
A.B.H.I
A,B,H,I
A.B.H.I
A,B,H,I
A, B.H.I
A.B.H.I
No
No 10/
No
No
No ]2/
No
Yes
No
No
Yes
No 10/
Yes
Yes 21/
No J£/
Yes
00148325 No JJ/
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirement:
64-1 - Submittal of Samples
TGAI or PAI A.B.H.I No
Reserved
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TABLE A
GENERIC EftTA REQUIREMENTS FDR PHOSMET
FOOTNOTES FDR PREVIOUS PAGES
§158.120 Product Chemistry
I/ Due dates refer to number of months following receipt of this Registration Standard or as otherwise indicated.
2f Information is obtained from the product registration file for the 94% technical product.
_3/ The following information on the 90% technical (476-2178) is required: the product name, trade name (if different),
and any experimental or internal code number the company has assigned.
4_/ The following information is required: (a) details of the manufacturing process, including the relative amounts of
beginning materials; a description of the equipment used to produce the product; reaction conditions; the duration
of each step of the process; purification procedures; and quality control measures for the 90% and 94% technical
products; (b) the nama and address of the manufacturer, producer or supplier of each beginning material used to
manufacture the 90% technical. A copy of all technical specifications, data sheets, and other documents in Which
the manufacturer, producer, or supplier describes the composition and properties of each beginning material used
to manufacture the 90% technical trust also be submitted? (c) the address of the manufacturer, producer, or supplier
of each beginning material used to manufacture the 94% technical.
V A discussion of each impurity which may be present at >_ 0.1% based on knowledge of the beginning materials, all
possible chemical reactions, and any contamination is required for the 90% and 94% technical products.
6/ Five or more representative samples of the 90% and 94% technical products must be analyzed for the amount of active
~~ ingredient and each inpurity present at >_ 0.1% (w/w) using valid analytical methods.
~lI The following data are required for the 90% and 94% technical products; (a) upper and lower limits must be
~ provided, validated, and certified; (b) upper limits must be provided, validated and certified for each toxioolog-
ically significant impurity present at <0.1% (w/w); (c) upper limits must be provided, validated and certified
for each impurity present at > 0.1% (w/w).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PtDSMET
§158.120 Product Chemistry (footnotes continued)
8/ Quantitative methods to determine the phosmet and all toxicologically significant impurities for which a certified
limit must be submitted on the 90% and 94% technical products. Each method must be accompanied by validation
studies of the precision and accuracy of the method.
9/ Adequate physical/chemical property information for the 90% and 94% technical products must be submitted unless
otherwise indicated.
10/ Not required because the technical is a solid at room temperature.
11/ Data was required by the June 29, 1984 Data Call-in letter for groundwater data.
12/ Not required because the melting point of the pure form of the active ingredient is > 30 °C.
13/ If samples are needed the Agency will request them.
-------
GENERIC DATA
TARTAR A
REQUIREMENTS FOR PHOSMET
Must
Additional
Does EPA Bibliographic Data be
Data Requirement Test Substance Have Data? Citation Submitted?
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism) 2/
- Plants PAIRA Partially 00037167,
- Livestock PAIRA Partially 001122241
171-4 - Residue Analytical Method £/
- Plant Residue TGAI and Metabolites Yes 00037165,
00037168,
00056852,
00067069,
00084808,
00095485,
00112262,
00112274,
00112313,
- Animal Residues TGAI and Metabolites Yes 00112241
- Storage Stability Data TGAI and Metabolites Partially 00056850,
00112312, Yes 3/
Yes V
00037166, No 6/
00056849,
00056862,
00078567,
00087762,
00112241,
00112265,
00112296,
05004211
No £/
00056851, Yes 7/
Timeframe
For Data
Submission^
18 Months f_/
18 Months f/
15 Months
00084815, 00097846,
00112279
171-4 - Magnitude of Residue -
Residue Studies for
Each Food Use 2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
Data Requirement
Test Substance
Does EPA Bibliographic
Have Data? Citation
Must
Additional Timeframe
Data be For Data
Submitted? Submission1
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue (continued) £
- Root and Tuber Vegetable Group £/
Potatoes TEP
Sweet Potatoes
TEP
Legume Vegetable (Succulent or Dried) Group
Peas (Dry and Succulent) TEP
Foliage of the Legume Vegetables Group
Pea Vines and Hay TEP
Fruiting Vegetables Group
Tomatoes
Citrus Fruits Group
Grapefruit
Lemons
Oranges
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Yes
00094636, 00112260
00112271, 00116855
Partially 00112262
00084814
00061721, 00084814,
00112283
00081616
Yes 18 Months f_/
Yes °/ 18 Months
Yes 12/ 18 Months V
Yes
No
18 Months V
Partially 00084810, 00112283 Yes £?_/ 18 Months f_/
Partially 00084810, 00112283 Yes £V 18 Months f_/
Partially 00084810, 00112283 Yes £V 18 Months f/
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TABLE A
GENERIC DATA REQUIREMENTS FDR PBOSMET
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional Timeframe
Data be For Data
Submitted? Submission
§158.125 Residue Chemistry (continued)
- Pone Fruit Group 18/
Apples TEP
Pears TEP
- Stone Fruits Group
Apricots TEP
Cherries TEP
Nectarines TEP
Peaches TEP
Plums (fresh prunes) TEP
- Snail Fruits and Berries Group
Blueberries TEP
Cranberries TEP
Grapes TEP
Partially
Yes
Partially
Yes
Partially
Yes
Yes
Yes
Yes
00044198, 00056854,
00056858, 00093486,
00106602, 00112302
00093486, 00116602
00037173
00037174
00037173, 00093486
00037173, 00056854,
00093486, 00106602
Yes 19/ 18 Months 4/
No
Yes 21/
No 22/
Yes 23/
Yes 24/
18 Months 4/
18 Months 4/
18 Months f_/
Partially 00037174, 00093486 Yes 25/ 18 Months 4/
00084809 No
00084812, 00112283 No
00037175, 00112247 Yes 28/ 18 Months 4/
-------
TABLE A
GENERIC DATA REQUIREMENTS PDR PHOSMET
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional Timeframe
Data be For Data
Submitted? Submission
§158.125 Residue Chemistry (continued)
- Tree Nuts Group 29/
Almonds TEP
Pecans TEP
- Cereal Grains Group 31/
Corn, Field and Fresh TEP
(including sweet kernels)
plus cob with husks removed)
Partially
Yes
00044198, 00056854,
00056858, 00093486,
Yes
Partially 00084813
18 Months
Yes ^/ 18 Months £/
00084811, 00112283 Yes 32/ 18 Months 4/
Forage, Fodder, Hay, and Straw of
Cereal Grains Group 33/
Corn Forage and Fodder
TEP
Yes
00037157, 0084811 No
Non-grass Animal Feeds Group 4/
Alfalfa TEP
Yes
00056858, 00095485 No 35/
Miscellaneous ContDdities
Cottonseed
TEP
Partially
00067068, 00112245,
00112281
Yes ^/ 18 Months */
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TABLE A
GENERIC DATA REQUIREMENTS TOR PHOSMET
Data Requirement
Does EPA
Test Substance Have Data?
Bibliographic
Citation
Must
Additional
Data be
Submitted?
Ttmeframe
For Data
Submission
§158.125 Residue Chemistry (continued)
Kiwifruit
TEP
Yes
00112279
No
- Magnitude of
Meat, Milk,
Eggs
the Residue in TGAI or Plant
Poultry, arid Metabolites
Partially 00037155,
00037162,
00078568,
00112249,
00112316,
05012698
00037161, Reserved 3//
00056860,
00078570,
00112310,
00112325,
_!/ Due dates refers to number of months following receipt of this Registration Standard or as otherwise indicated.
2/ Since completion of these data requirements requires a tiered approach (metabolism -> residue analytical methods ->
~ crop field trials/storage stability/processed foods and feeds -> meat/milk/poultry/eggs), the registrants must
submit any proposed variations in the tiireframe schedule for data submissions within 90 days after receipt of this
Guidance Document. Allowances to the requirel time lines will be made only if sufficient justification is provided,
i.e., the registrant states he does not have this data and due to the seasonal nature of the crop and the tiered
approach requirement, additional time is needed to satisfy the data requirement. The Agency reserves the right to
request necessary studies earlier than the period specified in the above tables and/or proposed timeframes.
3/ Data must be submitted on the uptake, distribution, and metabolism of l^C-carbonyl or ring-labeled phosmet in
~ representative mature crops, preferably an orchard tree fruit, potatoes, and corn (grain arid forage) following
foliar applications. The identities and quantities of residues in or on mature plant parts must be determined
in order to elucidate the terminal residues. Residue identities must be confirmed by a method such as QC, HPtx:,
arid/or mass spect romet ry. Data must also be presented that reflect the extraction efficiency of the sol vent (s)
used to r<3Tove residues following application of phosmet to living plants.
Note: Representative samples from the above-described tests must also be analyzed by accepted enforcement methods
to ascertain that these methods are capable of determining all metabolites of concern.
4/ Progress reports on t-he nature of the residue and crop field trial data is required 9 months after receipt of this
~ Registra*" LOU Notice. See footnote 3.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
§158.125 Residue Chemistry (footnotes continued)
5/ Metabolism studies utilizing ruminants and poultry must be submitted. Animals must be dosed for at least 3 days
~ with 14C-ring- or carbonyl-labeled phosmet at a concentration in the total diet that will result in sufficient
residues in the tissues, milk, and eggs for characterization. Animals must be sacrificed within 24 hours of the
final dosing. Milk and eggs must be collected twice daily. i^C-Residues in muscle, fat, kidney, liver, milk, and
eggs must be characterized.
Beef cattle and swine must be dermally dosed with 14C-ring- or carbonyl-labeled phosmet at a concentration that
will result in sufficient residues in the tissues for characterization. Animals must be sacrificed 24 hours (beef
cattle and swine) and 3 days (beef cattle only) after treatment and residues characterized in muscle, fat, kidney,
and liver.
Note; Representative samples from the metabolism studies requested above must also be analyzed using accepted
enforcement methods to ascertain their validity.
6/ If the requested data regarding the nature of the residue in plants and animals reveal additional metabolites of
toxicological concern, additional analytical methods for data collection and enforcement may be required.
_?/ The storage intervals and conditions of samples used to support all established tolerances for residues must be
submitted. These data must be accompanied by data depicting the percent decline in residues at the times and
under the conditions specified. (No additional stability studies are required for plant commodities stored frozen
for up to 1 year). On receipt of these data, the adequacy of the aforementioned tolerances will be reevaluated.
All residue data requested in this Standard must be accompanied by data regarding storage length and conditions of
storage of samples analyzed. These data must be accompanied by data depicting the stability of residues under the
conditions and for the time intervals specified, with the exception of plant commodities stored frozen for _< 1 year.
Data should delineate the stability of phosmet and its oxygen analog in animal products (tissues, milk, and eggs).
Spiked samples should be stored at subfreezing temperatures for intervals approximating the storage intervals
associated with treated samples used to determine the magnitude of the residue.
It should be noted that the nature of the residue in plants and animals has not been adequately described. If the
requested metabolism data indicate the presence of additional residues of toxicological concern in plant or animal
commodities, data depicting the stability of such residues in storage will be required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FHOSNET
§158.125 Residue Chemistry (footnotes continued)
8/ A group tolerance is not appropriate at the present time for the following reasons: (a) additional data are
required to support the established tolerance for residues in or on potatoes; (b) residue data and proposed uses
are required for additional members of this group (carrots, radishes, and sugar beets); (c) the use on sweet
potatoes (postharvest) is significantly different than that on potatoes (foliar) and the tolerance for re-
sidues in or on sweet potatoes (10 ppm) is more than 5X greater than that for residues in or on potatoes (0.1 ppm).
The tolerance for residues in or on sweet potatoes is too low and must be revised on receipt of required data.
Thus, if a crop group tolerance is sought to cover foliar uses on members of this crop group, sweet potatoes must
specifically be excluded.
9/ Residue data in or on potatoes, reflecting the maximum number of foliar applications and harvested 7 days after the
last foliar application with a WP formulation at 1 Ib ai/A, must be submitted. Applications must be made with
ground, aerial, and ULV equipment, in separate tests. Tests must be conducted in ID, ME, OR, WA, and WI, which
represent the major U.S. potato production regions. The registrant must propose a maximum number of applications or
the maximum seasonal use rate and submit data supporting such use.
Data reflecting residues in granules, chips, and dried potatoes processed from potatoes bearing measurable weathered
residues must be submitted. Exaggerated rates of application may be necessary to achieve such residue levels. If
residues are found to concentrate in any of the processed ccnrodities, appropriate food/feed additive tolerances
must be proposed.
10/ Data depicting residues in or on unwashed sweet potatoes treated postharvest with the 5% D at 0.2 oz ai/50 Ib must
be submitted. Samples must be collected immediately after treatment and at regular (weekly) intervals thereafter
until residues begin to decline. An appropriate tolerance revision must be proposed.
ll/ A. group tolerance is inappropriate at the present time for the following reasons: (a) proposed use directions
and residue data for one succulent and one dried variety of beans, and soybeans, all of which are representative
crops of the "Legume Vegetables Group" must be submitted, (b) additional data are required reflecting residues
in or on peas (succulent and dried) reflecting the maximum number of foliar applications of phosmet.
12/ The registrant must propose a maximum number of seasonal applications of phosmet and appropriate data supporting
such use must be submitted. Data reflecting the maximum number of applications must be submitted using the 50% WP
at 1 Ib/A using 20 to 50 gal water/A by ground and 5 to 10 gal water/A by aerial equipment. Pea samples (peas,
pods, dry seeds and forage) must be collected 7 days after the last application, and hay samples must be collected
10 days after the last application. Tests must be conducted in WA and OR, the major U.S. pea production areas in
the Pacific Northwest (Agricultural Statistics, 1984, p. 163).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
§158.125 Residue Chemistry (footnotes continued)
13/ A group tolerance is not appropriate at the present time for the following reasons: (a) proposed use directions
must be submitted along with appropriate data for vines and hay of beans, and for forage, hay and straw of soy-
beans; (b) additional data are required reflecting residues in or on peas vines and hay.
14/ A group tolerance is not appropriate at the present time because a proposal for use and residue data in support
of such use are required for peppers, a representative comodity of the "Fruiting Vegetables Group".
IS/ Phosmst is not registered in the U.S. for use on tomatoes. Available residue data support the established
tolerance for residues of phosmet in or on phosmet-treated tomatoes grown in Mexico. Since tomatoes imported into
the U.S. from Mexico are sold exclusively on the fresh market, no data regarding the potential for concentration
of residues on processing are required. However, it should be noted that if registration of phosmet for use
on U.S. grown tomatoes is requested in the future or imported tomatoes are marketed other than for fresh market
use only, additional residue data will be required.
16/ The data do not fully support the established group tolerance for phosmet residues in or on citrus for the
following reasons (a) tests with grapefruit did not include the maximum number of applications/seasons or
the use of spray oil, and (b) tests with lemons did not include the use of multiple applications at the maximum
application rate. In addition, the data indicate that residues may concentrate up to 4x upon processing to
citrus oil.
I7/ Residue data concerning grapefruit and lenons treated with 3 foliar applications made 30 days apart with the
50% WP formulation at 0.5 Ib ai/3000 gal/A (15 Ib ai/A) tank mixed with a suitable spray oil must be submitted.
A 7-day preharvest interval must be observed. Applications must be made using ground equipment only. Tests
mast be conducted in CA (both crops) and AZ (lemons only) which represent the major production areas in which use
is permitted (Agricultural Statistics, 1974, p. 200).
A food additive tolerance at 4X the accepted tolerance for residues in or on the raw agricultural commodity must
be proposed for residues in citrus oil.
1_8/ Based on the available data for apples and pears, representative connodities for the pome fruits group, the
registrant may propose a 10 ppm tolerance for residues of phosmet and it O-analog in or on the crop group
"Pome Fruit". See footnote 20.
19_/ Data reflecting phosmet residues in or on apple products (dry pomace and juice) processed from whole apples bearing
measurable weathered residues must be submitted. If residues are found to concentrate in any of the processed
ccrmodities, appropriate food/feed additive tolerances must be proposed. Also, to obtain a more acceptable
estimate of dietary exposure, the Agency is requiring additional processing studies indicating the effects of
washing and cooking.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMETT
Residue Chemistry (footnotes continued)
20/ A crop group tolerance is not appropriate because additional data are required to support the established tolerance
for residues in or on plums.
21/ Submit residue data reflecting the maximum number of applications in or on apricots 14 days after the last foliar
application with a WP formulation at 0.75 Ib ai/100 (3 Ib ai/A). Tests must be conducted using ground equipment.
Tests must be conducted in CA which products 95.7 percent of the total commercial U.S. apricot crop (Agricultural
Statistics, 1984, p. 193). As an alternative to submission of these data, the registrant may satisfy the data
requirement for plums and propose a crop group tolerance for residues in or on members of the stone fruits group.
22/ No additional residue data are required, however the tolerance entry (40 CFR §180.261) will be amended to read
"cherries sour" rather than cherries.
23/ Data reflecting residues of concern and the maximum number of applications in or on nectarines following the last
foliar application with a WP formulation at 0.75 Ib ai/100 gal (3 Ib ai/A) must be submitted. Tests must be
conducted using ground equipment. Tests must be conducted in GA which represents virtually all of U.S. nectarine
production (Agricultural Statistics, 1984, p. 213, which presents nectarine production data for CA only). As an
alternative to submission of these data, the registrant may submit the requested data for plums and propose a
group tolerance for residues in or on members of the stone fruits group.
24/ Although sufficent data are available to ascertain the adequacy of the established tolerances, the Agency is
requiring processing studies (washing and cooking) to obtain a more accurate estimate of dietary exposure.
25/ Data must be submitted reflecting residues of concern and the maximum number of applications in or on plums and
fresh prunes following the last foliar application with a WP formulation at 0.75 Ib ai/100 gal (3 Ib ai/A). Tests
must be conducted using ground equipment. Samples must be collected 7 days after the last treatment. Tests must
be conducted in CA which represents 91 percent of the total U.S. plum and fresh prune production (1982 Census of
Agriculture, Vol. 1, Part 51, p. 365).
Fresh prunes bearing measurable weathered residues must be processed to dried prunes to determine if concentration
of residues occurs; if so, a food additive tolerance must be proposed.
26/ A group tolerance is inappropriate at the present time for the following reason: proposed use directions must
be submitted alor«g with appropriate supporting data for additional crop group members strawberries and a Rubus spp.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSMET
§158.125 Residue Chemistry (footnotes continued)
27/ Although a tolerance on cranberries was previously based upon a specific use pattern there are currently no
registered uses for phosmat on cranberries. Therefore the Agency will propose revocation of this tolerance
under the Tolerance Revocation Program.
28/ Data reflecting residues in processed grape products .including wet and dry pomace, raisins and raisin waste
processed from grapes bearing measurable weathered residues of phosmet must be submitted. If residues are found
to concentrate in any of the processed commodities, appropriate food/feed additive tolerances must be proposed.
29/ A tolerance of 0.1 ppm (negligible residue) has been established for combined residues of phosmet and its oxygen
analog in or on nuts. A tolerance of 10 ppm has been established for the same residues in or on almond hulls.
The crop group tolerance for residues in or on nuts is not supported because data submitted on walnuts are in-
adequate (only two samples reflect a post-treatment interval of less than 61 days). Refer to footnote 31 for
data needed to support a group tolerance.
3Q/ Data depicting residues in or on the nutmeats, a representative cortinodity of the tree nuts group (40 CFR 180.34),
of walnuts following phosmet treatments according to the registered use on a nut crop likely to result in the
highest residues (pecans). Tests must be conducted in CA where virtually all U.S.-grown walnuts are produced
(Agricultural Statistics, 1984, p. 240). Alternatively separate tolerances of 0.1 ppm may be proposed for residues
in or on almond and pecan nutmeats and the tolerance for residues in or on "nuts" revoked.
31/ A crop group tolerance is inappropriate at the present time for the following reason: use directions and
tolerances must be proposed for additional group members rice, sorghum, and wheat.
32/ Data depicting residues in milled products and crude and refined oil processed from field corn bearing measurable
weathered residues must be submitted. If residues are found to concentrate upon processing, appropriate food
additive tolerances must be proposed. Treatment of the raw agricultural commodity with exaggerated rates may be
necessary to obtain measurable residues prior to processing.
-------
TABLE A
GENERIC EATA REQUIREMENTS FOR PHOSMETT
Residue Chemistry (footnotes continued)
33/ A crop group tolerance is inappropriate at the present time for the following reason: use directions and tolerances
must be proposed and appropriate data submitted for residues in or on wheat forage, hay, and straw and one other
cereal grains crop.
34/ A crop group tolerance is inappropriate at the present time for the following reason: use directions and tolerances
must be proposed for one additional group member (clover).
35/ The available data indicates that residues of phosmet in or on alfalfa hay and forage following use of the
registered formulations at the maximum rates will not exceed the established 40 ppm tolerance. 40 CFR §140.261
will be amended to delete the comodity entry "alfalfa" and add separate entries for "alfalfa forage and hay."
Furthermore, the data indicate that a tolerance of 20 ppm would be adequate for alfalfa forage, if the registrant
wishes to propose such a reduction.
36/ Data must be submitted to determine the residues in meal, hulls, soapstock, crude oil, and refined oil processed
from cottonseed bearing measurable weathered residues. It may be necessary to treat with exaggerated rates to
obtain measurable residues in the raw agricultural ccranodity. If concentration occurs in meal, hulls, or
soapstock, appropriate food/feed additive tolerances must be proposed. The adequacy of the tolerance for residues
in cottonseed oil will be assessed on receipt of these data.
37/ Presently, the nature of the residue in animals is not adequately understood. On receipt of the data requested
in the section entitled "Nature of the Residue - Livestock," the appropriate nature of tolerances for residues in
animal products will be determined. The adequacy of the available data regarding the magnitude of residues in
animal products will not be determined until all requested data regarding metabolism in animals and magnitude of
residues in feed items have been received. It should be noted that the available data indicate that phosmet and
its oxygen analog transfer to the fat of ruminants sprayed with phosmet.
-------
TABLE A
GENERIC DATA REQUIREMENTS R)R PH3SMET
Data Requirement
Composition
Does EPA Have
Use Data to Satisfy Bibliographic
Pattern This Requirement? Citation
Timeframe
Most Additional For Data Sub-
Data Be Submitted missionV
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
PH3TODEGRADATION
161-2 - In Water
161-3 - On Soil
161-4 - In Mr
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
NOBILITY STUDIES:
TGAI or PAIRA A,B,H
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A.B.H
TGAI or PAIRA A
TGAI or PAIRA N/A
TGAI or PAIRA N/A
163-1 - Leaching and/or TGAI or PAIRA A,B,H
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A
A
No
No
No
No
Yes
No
No
No
No
00112304
Yes 2/
Yes 2/
Yes
Reserved
9 Months
Yes f /
Yes 2/
No
No 2/
Yes 2/
9 Months
9 Months
27 Months
12 Months
12 Months
-------
GENERIC DATA REQUIREMENTS FOR FH3SMET
Data Requirement
Composition
Does EPA Have Must Additional Timeframe
Use Data to Satisfy Bibliographic Data be For Data
Pattern This Requirement Citation Submitted Submission^
§ 1 58 . 1 30 Environmental Fate (continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP
164-2 - Aquatic (Sediment) TEP
164-3 - Forestry TEP
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term TEP
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(field)
165-3 - Irrigated Crops
165-4 - In Fish
in Aquatic Nontarget
organisms
PAIRA
TEP
TEP
A.B.H
N/A
N/A
N/A
A
N/A
TGAI OR PAIRA A,B
TEP
No
N/A
N/A
No
No
No
N/A
No
No
Yes 2/
Reserved V
Yes
Reserved _£/
N/A
No £/
No
27 Months
39 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS R)R PHDSMET
Data Requirement
Composition
Does EPA Have
Use Data to Satisfy
Pattern This Requirement
Bibliographic
Citation
Must Additional
Data be
Submitted
Timeframe
For Data
submission^
158.75 - OTHER EXPOSURE DATA
Glove Permeability
Studies
A,B
No
Yes 7/
6 months -
acceptable
protocol
14 months-
final report
-------
TABLE A
GENERIC DATA REQUIREMENTS K)R PH3SMET
KXDTNOTES TO PREVIOUS TABLE
§158.130 Environmental Fate
j_/ Due dates refers to number of months following receipt of this Registration Standard or as otherwise stated.
2f The June 29, 1984 Data Call-in (DCI) notice required registrants to submit this data under a specificed
time schedule to satisfy the groundwater data requirements. The data submitted/cited in response to the DCI
were found unacceptable except for aerobic soil studies.
j}/ Contingent upon the results of the lab volatility study.
4/ Contingent upon residue dissipation rate in aerobic soil metabolism terrestrial and field dissipation studies.
If residues from these studies do not reach 50 percent dissipation prior to subsequent treatment, a long term
soil dissipation study is required.
_5/ Required if significant residues of concern found in the confined study.
6/ Octanol/water coefficient < 1000; therefore this test is not required.
II Quantitative data must be submitted regarding the permeation and breakthrough time of chemical resistant
~~ gloves used as protective clothing and equipment for all liquid formulations. If these data are not
available, they must be generated using methods described in American Society of Testing and Materials
(ASTM) 739-81-Standard Test Method for Resistance of Protective Materials to Permeation by Hazardous
liquid Chemicals. Because this type of testing is relatively new, it is recommended that testing protocols
for permeation studies be submitted prior to initiation of any study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
Data Requirement Composition
§158.130 Environmental Fate (continued)
Subpart K Reentry
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
Does EPA Have
Use Data to Satisfy
Pattern This Requirement?
A No
A No
A No
A No
Must
Bibliographic Additional Data
Citation Be Submitted?
— Yes
— No 3/
— No V
— No V
Timeframe
For Data
Submission^/
Dec. 31, 1986 2/
I/ Due dates refers to number of months following receipt of this Registration Standard or as otherwise indicated.
_2/ The February 28, 1985 Data Call-in notice for reentry data requires foliar dissipation data by December 31, 1986.
3/ Required if agricultural practice involves human tasks that would cause substantial exposure to residues
sorbed to soil. Registrant has agreed to label potato use for machine harvest only therefore this test is not
required.
4/ Not required if acceptable foliar dissipation data are submitted.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSMET
Data
§158
Requirement Test
.135 Toxicology
Substance
Use
Patterns
Does
Have
EPA Bibligraphic
Data? Citation
Must
Additional
Data be
Submitted?
Timeframe
For Data
Submission^
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye Irritation
- Primary Dermal Irritation
- Dermal Sensit 1 zation
- Delayed Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
Yes
Yes
No
Yes
Yes
No
Yes
00043470, 00046189
00063196
00046190, 00063196
00075439
—
00063195, 00046192
00046191
—
00109652
No
, No 2/
Yes
No 2/
No
Yes
No
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PHOSMET
Data
§158
Requirement Test Substance
.135 Toxicology (continued)
Use
Patterns
Does EPA Bibligraphic
Have Data? Citation
Must
Additional
Data be
Submitted?
Timeframe
For Data
Submission
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding: TGAI
- Rodent, and
- Nonrodent (Dog)
- 21-Day Dermal - Rabbit TGAI
- 90-Day Dermal - Rabbit TGAI
- 90-Day Inhalation: TGAI
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
Yes 00076436, 00076436
Yes 00076436, 00076436
No —
No —
No —
No 3/
No 4 /
Yes
No V
No 5/
12 Months
- Rat
82-5 - 90-Day Neurotoxicity:
- Hen
TGAI
A,B,H,I No
- Mammal
TGAI
A,B,H,I No
No 6/
-------
TABLE A
GENERIC EATA REQUIREMENTS FOR
Data
§158.
Use Does EPA Bibligraphic
Requirement Test Substance Patterns Have Data? Citation
135 Toxicology - (continued)
Must
Additional Timeframe
Data be For Data
Submitted? Submission
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Testing -
2 Species:
- Rodent, and TGAI A,B,H,I Yes 00076436
- Nonrodent (Dog) A,B,H,I Yes 00076436
- Oncogenicity -
2 Species:
- Rat (preferred), and TGAI A, B.H.I Partially 00076436
- Mouse (preferred) A,B,H,I Yes 00076436
- Teratogeriicity - TGAI A,B,H, I
2 Species:
- Monkey Yes 00053821, 00062649
- Rabbit Yes 00062649, 00053821
- Reproduction - Rat TGAI A,B,H,I Yes 00081432
2 Generation
No
No
Yes
No
No£/
No 2/
No
50 Months 7/
(8 months -
progress report)
MUTAGENICITY TESTING
84-2
84-2
- Gene Mutation (Ames Test) TGAI A,B,H, I No —
- Structural Chromosomal TGAI A,B,H,I No —
Yes
Yes
9 Months
12 Months
Aberration
84-4 - other Genotoxic Effects
TGAI
A,B,H,I No
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PBOSMET
Data Requirement
Test Substance
Use Does EPA Bibligraphic
Patterns Have Data? Citation
Must
Additional Timeframe
Data be For Data
Submitted? Submission
§158.135 Toxicology - (continued)
SPECIAL TESTING:
85-1 - General Metabolism
85-2 - Dermal Penetration
86-1 - Domestic Animal
Safety
PAI or PAIRA
Choice
Choice
A,B,H,I No
A,B,H,I No
A,B,H,I Partially
00075429
00080428
00112286
00112501
Yes 24 Months
Reserved 8/
Reserved 9/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSMET
FOOTNOTES TO PREVIOUS PAGES
§158.135 Toxicology
if Due dates refers to number of months following receipt of this Registration Standard or as otherwise indicated.
2/ Collectively the studies satisfy the data requirement.
3/ A 2-year chronic toxicity/oncogenicity study in rats exists that satisfies the requirement for the 90-day rodent
feeding study.
4/ A 2-year chronic toxicity study in dogs exists that satisfies the requirement for the 90-day nonrodent feeding
study.
5/ Data base and exposure scenario do not trigger testing at this time.
6/ The acute delayed neurotoxicity and acute toxicity test did not indicate neurotoxic effects.
7/ A progress report is due 8 months after receipt of this Notice and semi-annually thereafter. A final report
is due 50 months after receipt of this Standard.
&/ Submission of data is contingent upon the results of the rat oncogenicity study. If the oncogenicity study is
~~ positive, dermal penetration studies will be required.
9/ The Agency has received adverse effects/incidents concerning the use of phosmet as a flea dip (Paramite) on
~~ domestic pets (dogs and cats). The Agency is re-examining all studies concerning the toxicity and efficacy
of this product to determine if additional data, labeling or other action is warranted regarding the continued
registration of this product.
-------
TABLE A
GENERIC DATA REQUIREMENTS K)R PH3SMET
Data Requirement
Composition
Does EPA Have Must Tiraeframe
Use Data to Satisfy Bibliographic Additional Data For Data
Pattern This Requirement? Citation Be Submitted? Submission'/
§158.145 Wildlife and Aquatic
Organisms
SPECIAL TESTING
70-1 - Residue Level Monitoring TGAI
AVIAN AND MAMMALIAN TESTING
No
Yes 2/
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral Toxicity
- Avian Subacute Dietary
Toxicity
- Upland Game Bird, and
- Waterfowl
- Wild Mammal Toxicity
- Avian Reproduction
- Upland Game Bird, and
- Waterfowl
- Simulated Field Testing
- Manmals, and
- Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
A.H.I
A.H.I
A,H
A
A
A
A
A
Yes 00084460
Yes 00034769
Yes 00034769
No
Yes 001 25786
Yes 00105999
No
No
No
No 3/
No 2.7
No V
No 3/
No 2/
No
No
6 Months -
Acceptable
Protocol
18 months -
Final Report
-------
TABLE A
GEMERIC DftTA REQUIREMENTS FDR FHC
Data
§i5S
Requiretnari:- Ccsnnos1'
.145 Wildlife and Aquatic
,tion
Use
Does EPA Have
Data to satisfy
This Requirement
Must
Bibliographic Additional Data
Citation Be SufcerittscT?
Tinssf raise
For Dats
Submiss ion
Organise a - (continued )
72-4
72-5
72-6
72-7
- Fish Early Life Stage, and
- Aquatic Invertebrate
Life-Cycle
- Fish - Life-Cycle
- Accumulation
- Simulated Field Testing
TGAI
TOA1
TGAI
TGAI
TEP
A
A
A
A
A
iST0
No
NO
NO
NO
Yes 8/
Yes £/
— Reserved £/
Reserved $/
— Reserved ^/
15 Month
15 Months
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
TEP
Partially
00054197
Reserved
-------
TABLE L
GENERIC DATA REQUIREMENTS FOR PHOS^ET
Use
Data Requirement Composition Pattern
§158.145 Wildlife and Aquatic
Organisms - (continued)
- Actual Field Testing TEP
- Manuals A
- Birds A
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity TGAI
- Coldwater Fish Species, and A,H, I
- Warmwater Fish Species A,H
72-2 - Acute Toxicity to Freshwater TGAI A,H,I
Does EPA Have Must
Data to Satisfy Bibliographic Additional Data
This Requirement? Citation Be Submitted?
No — No
No — No
Yes 00063194, 00109135 No 5/
Yes 00063194 No V
Yes 00063193, 00063194 No
Timeframe
For Data
Submission
Invertebrates
72-3 - Acute Toxicity to Estuarine
and Marine Organisms
TEP
A,H,I
No
Yes
9 Months
- Fish
- Mollusk
- Shrinp
TGAI
TGAI
TGAI
A
A
A
No
No
No
Yes 1J
— Yes I/
Yes 7/
12 Months
12 Months
12 Months
-------
TABLE A
GENERIC E&TA REQUIREMENTS FOR FHDSMET
FOOTNOTES FOR PREVIOUS PAGES
§158.145 Wildlife and Aquatic
Organisms
I/ Due dates refers to number of months following receipt of this Registration Standard or as otherwise indicated.
2f Residue level nonitoring data is required to support the registration of phosmet use on apples, corn, cotton, and
alfalfa. Data on the residue levels on foliage, seeds, insects, and other avian and mammalian feed items in
treatment areas is required. Also data on residue levels in runoff water, and in the water and sediments of re-
representative streams and ponds in or near treatment areas is required. Monitoring should begin immediately
after typical maximum-rate applications of phosmet to apple orchards, corn, cotton, and alfalfa crops. Monitoring
should continue throughout the growing season and for six months after the last application. Monitoring must be
done on a minimum of six sites selected to be representative of the various sites where the crops are grown. For
corn, the selected sites must include sites from the corn belt and from the southern States . Registrants must
submit protocols before beginning the studies.
3/ When used together, the data on the upland game bird and the waterfowl fulfill the data requirement.
4/ Data on wild mammal toxicity are not usually required. There are no special circumstances here to indicate that
data should be required.
5/ When used together, the data on the coldwater species and the warmwater species fulfill the data requirement.
6/ Acute toxicity data on the end-use product is required vihen the EC5Q of the technical grade of the active
ingredient is equal to or less than the maxiinum expected environmental concentration (MEEC) or the estimated
environmental concentration (EEC) in the aquatic environment when the end-use product is used as directed.
In this case, the ECso of the technical grade of the active ingredient is less than the EEC resulting from use
on apples, corn, cotton, and alfalfa. Therefore, data on the formulated products registered for use on these
crops are required.
7/ Data are required to support registrations for use on corn, cotton and citrus.
8/ Data are required because the pesticide use pattern is such that its presence in water is likely to be continuous or
~~ or recurrent, the U2c,0 and EC50 values for fish and aquatic invertebrates are less than 1 mg/L, and the
estimated environmental concentrations in water is greater than 0.01 of the LCso and EC5QS.
9/ The Agency reserves the option of requiring data in these categories, pending the outcome of the fish embryo- larvae,,
~~ invertebrate life-cycle, and field moriitoring tests.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR FHOSME7T
Does EPA Have Must Time frame
Use Data to Satisfy Bibliographic Additional Data For Data
Composition Pattern This Requirement? Citation Be Submitted Submission _V
Data Requirement
§158.155 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS:
141-1 - Honeybee Acute Contact TGAI A,B,G
LD50
142-2 - Honeybee - Toxicity of TEP A,B,G
Residues of Foliage
141-4 - Honeybee Subacute Feeding [Reserved]V
Study
141-5 - Field Testing for
Pollinators
TEP
A,B,G
NDNTARGET INSECT TESTING - AQUATIC INSECTS;
Yes
Yes
No
00066220
00060625
No
142-1 - Acute Toxicity To
Aquatic Insects
142-2 - Aquatic Insect Life-
Cycle Study
142-3 - Simulated or Actual Field
Testing for Aquatic
Insects
E Reserved JV
[Reserved]£/
[Reserved]^/
143-1 - NDNTARGET INSECT TESTING - [Reserved]^/
Thru PREDATORS AND PARASITES
143-2
-------
TABLE A
GENERIC E&TA REQUIREMENTS FOR PHOSMET
FOOTNOTES FOR PREVIOUS TABLE
§158.155 Norrtarget Insect
I/ Reserved pending development of test methodology.
2/ Requirement for field studies is imposed only on a case-by-case basis. Data reviewed to date do not indicate the
need for a field study.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FUR MANUFACTURING-USE PRODUCTS CONTAINING PHOSMET
Must Additional Timeframe
Use Does EPA Bibliographic Data be For Data
Composition3-/ Pattern Have Data? Citation Submitted
Data Requirement
Submission^
§158.120 Product Chemistry
Product Identity and Composition;
61-2 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Ma-
terials and Manufacturing
Process MP
61-3 - Discussion of Formation of
Impurities MP
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of Ingredient
Limits MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Physical and Chemical Characteristics 10/
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
A,B,H,I Partially
A,B,H,I Partially
A,B,H,I No
Yes
Yes V
Yes 6/
A,B,H,I No
A,B,H,I No
Yes 7/
Yes 8/
A,B,H,I Partially 00112317, 00112263 Yes 9/
00126567, 00112314
A,B,H,I No
A,B,H,I No
A,B,H,I No
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS K)R MANUFACTURING-USE PRODUCTS CONTAINING PHDSMET
Data Requirement
Use Does EPA
CompositionV Pattern Have Data?
Must Additional Timeframe
Bibliographic Data be For Data
Citation Submitted Submission^
§158.120 Product Chemistry (continued)
Product Identity and Composition:
63-7 - Density, Bulk Density, or
Specific Gravity
MP
A,B,H,I No
Yes
6 Months
63-12 - pH
MP
A.B.H.I No
Yes
6 Months
Other Requirement:
64-1 - Subnaittal of Samples
MP
A,B,H,I No
Reserved 1'/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING PHDSMET
FOOTNOTES FDR PREVIOUS PAGES
§ 158.120 Product Chemistry
_]_/ The 90% and 94% technical serve as the manufacturing-use products.
2/ Due dates refer to number of months following receipt of this Registration Standard or as otherwise indicated.
JV Information is obtained from the product registration file for the 94% technical product.
4/ The following information on the 90% technical (476-2178) is required: the product name, trade name (if different),
and any experimental or internal code number the company has assigned.
5/ The following information is required: (a) details of the manufacturing process, including the relative amounts of
~ beginning materials; a description of the equipment used to produce the product; reaction conditions; the duration
of each step of the process; purification procedures; and quality control measures for the 90% and 94% technical
products; (b) the name and address of the manufacturer, producer or supplier of each beginning material used to
manufacture the 90% technical. A copy of all technical specifications, data sheets, and other documents in which
the manufacturer, producer, or supplier describes the composition and properties of each beginning material used
to manufacture the 90% technical must also be submitted; (c) the address of the manufacturer, producer, or supplier
of each beginning material used to manufacture the 94% technical.
6/ A discussion of each impurity believed to be present at )> 0.1% based on knowledge of the beginning materials, all
possible chemical reactions, and any contamination is required for the 90% and 94% technical products.
Tj Five or more representative samples of the 90% and 94% technical products must be analyzed for the amount of active
ingredient and each impurity present at >_ 0.1% (w/w) using valid analytical methods.
S/ The following data are required for the 90% and 94% technical products: (a) upper and lower limits must be
provided, validated, and certified; (b) upper limits must be provided, validated and certified for each toxicolog-
ically significant impurity present at <0.1% (w/w); (c) upper limits must be provided, validated and certified
for each impurity present at >^ 0.1% (w/w).
9/ Quantitative methods to determine the phosmet and all toxicologically significant impurities for which a certified
limit must be submitted on the 90% and 94% technical products. Each method must be accompanied by validation
studies of the precision and accuracy of the method.
_10/ Adequate physical/chemical property information for the 90% and 94% technical products must be submitted unless
otherwise indicated.
11/ If samples are needed the Agency will request them.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSMET
Data Requirement
Test Substance
Use Does EPA Bibligraphic
Patterns Have Data? Citation
Must
Additional Timeframe
Data be For Data
Submitted? Submission^
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dental Toxicity
- Rabbit
81-3 - Acute Inhalation Toxicity
- Rat
81-4 - Primary Eye Irritation
- Rabbit
81-5 - Primary Dermal Irritation
-Rabbit
81-6 - Dermal Sensitization
-Guinea Pig
MP
MP
MP
MP
MP
MP
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
A,B,H,I
Yes
Yes
No
Yes
Yes
No
00043470, 00046189, No
00063196
00046190, 00063196, No
00075439
Yes 9 Months
00063195, 00046192 No 3/
00046191
No
Yes 9 Months
If Composition: MP= Manufacturing Use Product
2/ Due date refers to number of months following receipt of this Registration Standard or as otherwise .indicated,
3/ Collectively the studies satisfy the data requirement.
-------
II. LABELING APPENDICES
-------
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 panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 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)]
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 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 1C. 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)(1)(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)].
-------
SUMMARY.-3
Item BA, 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) ot exposure and the precautions to be taken to avoid
accident, injury or damage. [4U CFR 162. 10 ( h) ( 2 ) ( i ) J
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature ot
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162. 10(h ) (2 ) (ii ) J
Item BC. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to 1lammabi1ity ot a product
are required to appear on the label it it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results ot the tlashpoint determinations and
tlame extension tests required to be submitted tor 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 - FIFKA sec. 3(d)
requires that all pesticide formulations/uses be classified
tor either general or restricted use. Products classified
tor restricted use may be limited to use by certitied 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 tormulations/uses are to be restricted (Section IV
indicates why the product has been classified tor restricted
use); or (2) reserved any classitication 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).
It 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 ot
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.
-------
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 in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
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)
Signal 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 tront
panel or end
of label text
Bottom tront
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
jDroduct 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 tor . . .,"
"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.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
1C
ID
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
pre caut 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-
caut ionary
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
precautionary
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
-------
§ 1*2.10 Labeling requirement*.
(a) General—(.1) Content* of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
4t) The name, brand, or trademark
under which the product Is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(ill) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
-------
Environmental Protection Agency
§ 162.10
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification^) 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
couspicuousness (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.
(11) All required label text must:
(A) Be set In 8-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
aJi labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product, For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" sh&U mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if it is a part of the package as
customarily distributed or sold.
(11) Tank can and other bulk con-
tainer*— g comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device Is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
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:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(is) Claims as to the safety of the
pesticide or Its ingredients, including
statements such as '"safe," "nonpoison-
ouSp" "noninjurious/8 "harmless" or
"nontoxte to humans and pets" with
-or without sucH iTqualifying 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 (a)(6)(ii) of
this section, final printed labeling
must 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.
Has not been approved by the
Administrator through registratte or
supplemental registration SB an addi-
tional name pursuant to i lS2.8CbX4).
(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
ed by * * V ©r "Sold by • • •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents, (1) The net weight or measure
of content shall be exclusive of wrap-
peri or other materials and shall be
the average content unless explicitly
(2) If the pesticide-is a liquid, the
net content statement shall be in
terms of liquid meswsre at 68* P C20*C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurised, or is a
mixture of liquid and solid, the net
content 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, Le., "1 pound 10 ounces" rather
than "26 ounces.1"
(5) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(6) Variation above rotoiiaum con-
tent or around an average is permissi-
ble only to the extent that It repre-
•sents deviation unavoidable to good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no sfeaE-the average con-
tent of the packages in a shipment fall
below the stated a?erage ©ontent.
(e) Product registration number.
The reftefcmtion number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded bj the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set In type of & and style similar to
other print on that part of the label
on which It appears and shall run par-
allel to it The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
-------
environmental Protection Agoncy
9 1*2.10
or endorsement of the product by the
Agency.
(f) Producing establishment* regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—d) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of al! Inert Ingredi-
ents; and If the pesticide contains ar-
senic tin any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredients by the
term "inert Ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the Ingredient statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement,
(1) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the ingredient statement canst
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(11) The text of the ingredient state-
ment must run parallel with other
text on the panel oh which it appears,
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each In-
gredient shall be the accepted
common name, If there is one. fol-
lowed by the chemical name. The
common name m&y be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless auch
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cX6).
<4) Statements of percentages. The
percentage® of Ingredients shall be
stated In terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of value® auch &e "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Detcricrzticr* Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
bviuiK i equirements:
(1) In case® where It is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up tc the expiration time indi-
cated on thel&beL
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredienUs) to be listed in the
ingredient statement if he determines
that such Ingredients) may pose a
hazard to man or the environment-
-------
§ 16X10
40 CM Ch. I (7-1 -45 idifton)
(h> Warnings and precautionary
statements. Required warning* and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two group-;
those required on the front panel of
the labeling and those which raay
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below,
(1) Required front panel statements.
With the exception ©f the child
hamrd warning statement, the text re-,
quired on the front panel of the label
Is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any ©f the indicators
in the table b®low:
Hazard (nctteertore
i
IV
omLO..
Inhataton
Up to end im***»a M
UfT»«n4lncfex«ng.2
Up to and hKfeKflng 200
FromSOttvui
From J «*M X rngfrnmr.
From 200 Shru 2000—
ComMlofweNy
®f«Mi»w »MW» 80 mg/lt*.
@wn 30.000.
w«Nn7«dw
72 tours.
(i) Human hazard signal word—4A)
Toxicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxidty (&s
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison,"
(B) Toxicity Category II. AH pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category HI. All pesti-
cide products meeting the criteria of
Toxicity Category HI snail bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
such labeling is necessary to pre-
vent imrea&oa&M© adverse effects on
m&a or the environment. In no case
shall more than erne human hazard
signal word appear ®n the front panel
of a label.
CM) Child haz&rd w@.mtn$. Every pes-
ticide product label shall tear on the
front panel the statement "keep out of
reach of children," Only to cases
where the likelihood of contact with
children during distribution, market-
ing, ^storage or use is demonstrated by
the applicant to be extremely remote,
or if tbe nature of toe pesticide is such
that it is approved for use on infants
or imall cMMren, may the Administra-
tor waive fchii requirement
of pro£#©al treat-
'TosAcity Category L A
statement of practical treatment (first
aid or other) chall aopear on the front
panel of the lalbel of all pestkkta fall-
Ing teto ToiMty Category I on the
basis of ©rti, MhnfaW*** or dermal tox-
fcdty. T&e Agency ramy. however,
permit re&ionable vmj-ig&om in the
pi&oement of the statement of practi-
cal treatmmt Is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
-------
Environmental Protection Agency
§ 162.10
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiiiXA) 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 (h)(2) of this
section if they do not appear on the
front panel.
imni«, precau-
tionary statements are required indi-
cating the particular hazard, the
routes) 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.
Toridty
category
Precautionary ttatementa by todctty category
Orel. Inhalation, or dermal toxtetty
SWn and eye local «ftects
m.
IV.
Fatal (potoonoua) V swallowed (Inhaled w abeorbed
through *WnJ. Do not breathe vepor (dust or aoray
mbU. Do not get In eye*, on sun, or on clothing
[Front panel (tatement of practical treatment re-
quired.].
May be taW M ewOowed (inhaled or absorbed
through toe eWn]. Do not breath* vapors {duct or
•pray mtoU. Do not gat In eye*, -on iMn. or on
clothing. (Appropriate On* tU ctatementa required.].
HarmM IT twatowed (Inhaled or abaorbed through the
eWnJ. Avoid breathing vapor* (dutt or apray mM].
Avoid contact «*h etan (eye* or clothing]. (Appro-
priate flrat aid atatamant required.].
CNo precautionary rteHrmmi «iqulnnt J
Corrosive. cau*M eye and cWn damage (or aUn
Irritation]. Oo not oat In eyes, on aUn. or on
clothing. Weer &*&** _pr face tnictd and rubber
gtowe* whan riandSng. HamM or fatal * ewaftowed.
(Appropriate tnt aid statamant required.]
GAUMS aye (end sWn] Mtatioa Do not gat In eye*,
on sMn, or on cSc«*^. HarmU • iwa*o<»*d. (Ap-
proixiafa first $)M atatatnent fejquiredj
Avoid oontes! wM« akin, eyaa or dotting, m CM* of
eonttet immeelaMy «ueh «yoa or akin «*h plan*/ o»
water. Oat madfeai •ttantion •
(No |
inequtwt]
(il) Environmental hazards. Where a.
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damage. Examples of the
hazard statements and the circum-
-------
§ 162.10
Ch. i (7-1 -#5 idition)
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less,
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
nag/kg or less, or a subacute dietary
LCw 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 ©r mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
CE) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
acniRlte applications the label must
bear the caution "Keep out of lakes,
Do not contaminate
or d!s-
(1ID Physical or chemical hazards.
Warning statements on the fl&mnmbtt-
ity or explosive characteristics of the
pesticide are required M follows:
Rash point
(A) PWSMUW2E0 CONTAINERS
Flash point at or below 20' F; N thare to a flashback at
any valv» opening.
Flash point above 20* F and not over 80* F or H th®
flame extension la mot* than 18 In long at a
of 6 in from the flame.
AJI other pressurized containers.™.. -,,,,,..,. ..
Bitremafy ftenmabte. Contest under pressure. Keep away from
fir*, spafte, and heatad curiacm. Do rtot ptmetov or Incinerate
oontaJnar. Exposure to tompwatyras above 130* F may cau>«
bursting.
FlammaW*. Contents under prowur*. K*«p eway from h«at.
•parks, and opan Kimo. 0@ not ^nctura w lndn«ret« oontainar.
Expoaw* to samp^nt^trss etov» 130* F may caue® bursting.
Contents urntw pmegiura. (to not us« or §to*ss mar neat or cp*n
(lam«. Do m>t pur«tur« o? kndrt®rat« oonteiner. Exposura to
130* F m
(B)
At or batow 20* F..
Above 20* F and not ovw 80* F
Above eo* F and not over ISO* F
Extn»m«fy fla*nm*bto. K««p away torn fir®.
F!«mm«fe*8. K®s»p awey from J^^S and e^«n terns.
Do not w« or gtera st*w teat s»? op«n tone.
(i) Directions for Use—<1) General
reoTfircTn^nia—(i) ^ltf«9uacv an«i clar-
ify o/ direciion-s. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
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 grai
(A) If required
printed or
which ac-
p«gtidd® provided that:
by the Agency, such
matter is securely
package of the pesti-
withln the outside
wrapper or
-------
Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products In
their regular manufacturing processes,
provided that*
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of the general public except
after incorporation, into finished prod-
ucts; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxidty, methods of use.
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.KKJ) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling.*
(ill) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pestts) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application. In-
cluding instructions for dilution, if re-
quired, and type
-------
§162.11
40 CFR Gh. I (7-1 -85 E«§ifi®«)
(E) For restricted use pesticides, a,
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only fee applied under
the direct supervision of a certified ap-
plicator who is physically present,
which the Administrator determines
to be necessary for the protection of
(j) Statement of Use Classification.
By October 22.1976, all pesticide prod-
ucts must beacon their labels a state-
ment of use classification as described
in paragraphs (j) (I) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with differen-
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of § 162.10(jX2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) 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 con-
tained in the Directions for Use will be
considered a false ©r misleading state-
ment; under the statutory definition,?,
of misbranding.
(2) Restricted Use Classlflca&i&n,
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:
(f) Front panel.statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
ls in % J@2.10(hXlXiv)). and appear-
with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "Restricted Use Pesticide" shall
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
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.
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°b'
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.
-------
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 ot
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 ot storage which might adversely
affect the container ot 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 tor
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.
-------
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 E'ederal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
-------
PEST/DIS-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
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (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-Diethyl 0-pyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl O-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
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide'
Sodium fluoroacetate
P003
P070
P004
POOS
POO 6
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
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
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
60-41-3
0,0,0,0-Tetraethyl P109 3689-24-5
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate P115 7446-18-6
Thiofanox P045 39196-18-4
Toxaphene P123 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
F027
F027
F027
F027
F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ether
Dehydroabietylanmonium
pentachlorophenox ide
Erbon
0-ethyl O-(2,4,5-trichlorophenyl)
ethylphosphonoth ioate
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(Hexachlorophene)
—Potassium salt of
—Sodium salt of
—Disodium salt of
Pentachlorophenol
—Potassium salt of
—Sodium salt of
—Zinc salt of
—Zinc salt of N-alkyl
(Cig-Cl8)~1'3-propanediamine
—Pentachlorophenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorophenate (2,4,5)
Silvex
—2-Butoxyethyl ester
—Butoxypolypropoxypropyl ester
—Butoxypropyl ester
—Diethanolamine salt
—Diisopropanolamine salt
—Dime thy lamine salt
—Dipropylene glycol isobutyl
ether ester
—Ethanolamine salt
—2-Ethylhexyl ester
—Isooctyl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
67923-62-0
3247-34-5
5736-15-2
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
-------
PEST/DIS-4
—Isopropanolamine salt F027 53404-13-0
—Monohydroxylaluminum salt F027 69622-82-8
—Polypropoxypropyl ester F027 83562-66-7
—Potassium salt F027 2818-16-8
—Propylene ylycol isobutyl F027 53466-84-5
ether estor
—Sodium salt F027 37913-89-6
—Triethanolamine salt F027 17369-89-0
—Triethylamine salt F027 53404-74-3
—Triisopropanolamino salt F027 53404-75-4
—Tripropylone glycol isobutyl F027 53535-30-1
ethconut oil)
—Potassium salt F027 53535-27-6
—Sodium salt F027 25567-55-9
2,4,5-Trichlorophenol F027 95-95-4
2,4,6-Trichlorophenol F027 88-06-2
2,4,5-Trichlorophenol salt of F027 53404-83-4
2,6-bis [ (dirnethylamino)inethylj
cyclohcxanone
2,4,5-Trichlorophenol, sodium salt F027 136-32-3
2,4,6-Trichlorophenol, sodium salt F027 3784-03-0
2,4,5-Trichlorophenoxyacetic acid F027 93-79-8
—Alkyl C-12 amine salt F027 53404-84-5
—Alkyl C-13 amine salt F027 53404r-85-6
—Alkyl C-14 arnino salt F027 53535-37-8
—N,N-diethylethanolamine salt F027 53404-86-7
—Dimethylamine salt F027 6369-97-7
—N,N-dimethyllinoleylamine salt F027 53404-88-9
—N,N-dimethyloleylamine salt F027 53404-89-0
—N-oleyl-l,3-propylene F027 53404-87-8
diamine salt
—Sodium salt F027 13560-99-1
—Triethanolamine salt F027 3813-14-7
—Triethylamine salt F027 2008-46-0
—Alkyl (C3H7 - C7H9) ester F027
—Amyl ester F027 120-39-8
—Butoxyethoxypropyl ester F027 1928-58-1
—2-Butoxyethyl ester F027 2545-59-7
—Butoxypropyl ester F027 1928-48-9
—Butyl ester F027 93-79-8
—Dipropylene glycol isobutyl F027 53535-31-2
ether ester
—2-Ethylhexyl ester F027 1928-47-8
—Isobutyl ester F027 4938-72-1
-------
PEST/DIS-5
—Isopropy1 ester
—Propylene glycol isobutyl
ether ester
—Tripropylene glycol isobutyl
ether ester
4-(2,4,5-Trichlorophenoxy)butyric
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl
hydrogen sulfate [2,4,5-TES]
l,4',5'-Trichloro-2'-(2,4,5-
trichlorophenoxy)
methanesulfonanilide [Edolan U]
F027
F027
F027
F027
F027
FU27
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)]
Acetone
Acrylonitrile*
Ami t role
Benzene*
Bis ( 2-ethylhexyl ) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chloroacetaldehyde )
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-Dichlorobenzene*
Dichlorod i fluorome thane
(Freon 12®)
3 , 5-Dichloro-N- ( 1 , l-dimethyl-2-
propynyl ) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(ODD)
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
U070
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
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrotluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
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-N i trophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31J
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*
Trichloromonofluoronethane
(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
UU29
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
UU80
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
-------
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
-------
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 )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
tor recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or,- it allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. It burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
V Manufacturer may replace this phrase with one indicating
~ whether and how fiber drum may be reused.
-------
III. USE INDEX APPENDIX
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHrHALIMIDE S-(0,0-D1METHYL PBOSPBORODITHIOATE)
TABLE OF CONTENTS
Site Name __ Page
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
Alfalfa 3
Almond 4
Apple 5
Apricot 6
Blueberry 7
Cherry, Sour (Tart) 7
Citrus Fruits 8
Corn 8
Cotton 9
Grapes 10
Kiwi Fruit 10
Lemon 11
Nectarines 11
Orange 11
Peach 12
Pear 12
Peas 13
Pecan 14
Plum 14
Potato 15
Prune 14
TERRESTRIAL NON-FOOD CROP 15
(Ornamental Plants and Forest Trees) 15
Christmas Tree Plantations 15
Loblolly Pine (seedlings) 15
Ornamental Shrubs 16
Ornamental and/or Shade Trees 16
Slash Pine (seedlings) 15
Western Pines 17
White Pines (seedlings) 15
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 17
Wide Area and General Outdoor Treatments17
DOilESTIC OUTDOOR 17
(Ornamental Plants and Forest Trees) 17
Domestic Dwellings, Outdoor 17
INDOOR 18
(Agricultural Crops) 18
Sweet Potato 18
(Pets and Domestic Animals) 18
(Animals and Their Man-Made Premises) 18
Beef Cattle 18
Cats 21
Dairy Cattle (non-lactating) 22
Dogs 24
Issued: 7-22-85 III-059201-i
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
TABLE OF CONTENTS
Site Name Page
Swine 26
Issued: 7-22-85 III-059201-ii
-------
EPA Compendium of Acceptable Uses
c059201 N-(MERCAPTOMETHYL)PKTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)*
TYPE PESTICIDE: Insecticide, Acaricide
FORMULATIONS;
Tech (90%, 94%)
D (1%V 5%)
WP (7.5%, 12%, 12.5%, 50%, 70%)
Impr (15%)
EC (1 Ib/gal„ 3 Ib/gal, 11.6%, 12.5%)
F1C (5 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; Do not plant any food or feed crop in
rotation within 1 month after last application unless it is a registered
use for phosmet. Crops registered for use with phosmet may be planted
immediately following last application. Do not use water containing phos-
met residues to irrigate crops used for food or feed which are not regis-
tered for use with phosmet.
Phosmet is incompatible with alkaline materials such as spray lime, lime
sulfur, and bordeaux mixtures. These materials will reduce the insecti-
cidal activity. Insecticidal activity may also be reduced when the water
in the spray solution has a pH of 7 or higher. The pH of the spray solu-
tion may be corrected by the addition of a suitable buffering or acidify-
ing agent for optimum insecticidal activity.
Protective Clothing Statements (Terrestrial Food Crop, Terrestrial Nonfood
Crop, and Domestic Outdoor);
When mixing/loading wear mid forearm to elbow length chemical resistant
gloves, long sleeve shirt, and long pants. During the application wear
long sleeve shirt and long pants. Applicator must also wear a wide-
brimmed hat during upward directed spraying to fruit and nut crops. Do
not allow worker reentry Into treated fields within 24 hours of applica-
tion unless appropriate protective clothing is worn.
Bee Caution;
Phosmet is highly toxic to bees exposed to direct treatment on blooming
crops or weeds. Do not apply phosmet or allow it to drift to blooming
crops or weeds while bees are actively visiting the treatment area.
Agricultural Crop Tolerances (other than those listed in the text):
Cranberries 10 ppm
Nuts 0.1 ppm
Tomatoes 2 ppm
Livestock Tolerances:
Goats (fat, meat, meat byproducts) 0.2 ppm
Horses (fat, meat, meat byproducts) 0.2 ppm
Sheep (fat, meat, meat byproducts) 0.2 ppm
Endangered Species Restrictions;
The use of any pesticide in a manner that may kill or otherwise harm an
endangered or threatened species or adversely modify their habitat is a
violation of federal laws. The use of phosmet is controlled to prevent
death or harm to endangered or threatened species that occur in the fol-
lowing counties or elsewhere in their range.
*phosmet
Prolate
Imidan
Issued: 7-22-85 III-059201-l
Provisional Update: 7-15-86
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALD1IDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
GENERAL WARNINGS AND LIMITATIONS (continued)
Before using this pesticide in the following counties you must obtain the
EPA Cropland Endangered Species Bulletin. The use of this pesticide is
prohibited in these counties unless specified otherwise in the Bulletin.
The EPA Bulletin is available from either your County Agricultural Exten-
sion Agent, the Endangered Species Specialist in your State Wildlife Agen-
cy Headquarters or the appropriate Regional Office of either U.S. Fish and
Wildlife Service (FWS) or the U.S. Environmental Protection Agency. THIS
BULLETIN MUST BE REVIEWED PRIOR TO PESTICIDE USE.
SPECIES
STATE
COUNTY
Alabama cavefish
Bayou darter
Colorado squawfish
Cui-ui
Freshwater mussels
Gila topminnow
Lahontan cutthroat trout
Leopard darter
Moapa dace
Pahranagat
Pahrump killifish
Slackwater darter
Unarmored threespine
stickleback
Woundfin
AL
MS
CO
NV
AL
AR
KY
AZ
CA
AR
NV
NV
NV
AL
CA
AZ
NV
Lauderdale
Copia
Blanco, Delta, Garfield, Mesa,
Moffat, Rio and Routt
Washoe
Colbert, Jackson, Marshall and
Morgan
Clay, Clark, Cross, Lawrence,
Randolph, Sharp and St. Fran-
cis
Ballard, Edmundson, Jackson,
Laurel, Marshall, McCracken,
Pulaski, Rockcastle, Warren
and Wayne
Graham and Santa Cruz
Alpine, Mono, Nevada, Placer
and Sierra
Sevier
Clark
Lincoln
Clark and White Pine
Lauderdale, Madison and Lime-
stone
Los Angeles and Santa Barbara
Mohave
Clark
Definition of Termg;
Tbls/tsp actual* (Tn dose column) - A hypothetical quantity computed by
multiplying the number (or equivalent number) of tablespoons/teaspoons of
product by the concentration of phosmet in the formulation.
^ (in dose column) - Exact computation of actual dosage is not possible
because of the lack of weight/volume information on the label. Extrapola-
tion from other formulations reveals that the dosage from this label
appears to fall within the range shown by formulations with known
weight/volume ratios.
j? (in dose column) - Computed from tablespoons/teaspoons dosage.
Parenthized pest name - Claims for pest control limited to suppression of
population are indicated by entirely parenthesized pest name.
Issued: 7-22-85
III-059201-2
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL) PHTHALIMIDE S-( 0,0-DIMETHYL PROSPHORODIIH10A!i,L)
Site and Pest
Dosages and Tolerance, Use, Limit at i_&nj3
Formulatlonf =0
23001AA
10ABANA
INASBWJ
INASBWC
INASBTJ
INASBTC
K1EAKA
IRAFAJA
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Unless otherwise specified^
aircraft or by ground equipment including concentrate and semiconcen-
trate equipment. When concentrate and semiconcentrate sprays are useds,
use proportionately lower volumes of water. In CA apply a minimum of 2
pounds per acre on mature pome and stone fruit trees and 1^75 pounds
per acre on cherries.
Alfalfa
Alfalfa blotch
leafminer
Alfalfa weevil
(adults)
Alfalfa weevil
(larvae)
Egyptian alfalfa
weevil (adults)
Egyptian alfalfa
weevil (larvae)
Meadow spittlebug
Potato leafhopper
40 ppm
7 day preharvest/pregrasing interval
through 1 pound per acre for foliar
application in areas other than AZ,
CA and NV.
14 day preharvest /pregrazing inter-
val through 0,75 pound per acre for
foliar application in AZt CA, and
NV.
Do not make more than 1 application,
per cutting.
Do not apply during bloom.
Apply wettable powder formulations
in 5 to 10 gallons of water per acre
by aircraft and in 10 to 50 gallons
of water per acre (20 to 50 gallons
of water per acre in dense stands)
by ground equipment. Apply emulsi-
fiable concentrate formulation in a
minimum of 10 gallons of water per
acre by ground equipment. Use di-
luted emulsion within 3 hours after
forming. Do not apply any sprays
with a spreader-sticker.
1 Ib/A Use limited to areas other than A2 :.
(50%, 70% WP) CA and NV.
Foliar application. For alfalfa
blotch leafminer and meadow spittle-
bug, apply at first sign of infests-
tion. For alfalfa weevil and
__
tian alfalfa weevil;, apply when lar-
vae are actively feeding or during
periods of adult activity. For
potato leafhopper in the Northeast
and North Central States.
Issued: 7-22-85
III-059201-3
-------
INASBWA
INASBVC
INASBTC
IRACAIA
/03001AA
ITAMABA
ITAMABA
IRAKBYA
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Alfalfa (continued)
Alfalfa weevil
Alfalfa weevil
(larvae)
Egyptian alfalfa
weevil (larvae)
Pea aphid
Almond
Peach twig borer
Peach twig borer
San Jose scale
Dosages and Tolerance, Use, Limitations
Formulation(s)
1 Ib/A Foliar application. Apply when lar-
(3 Ib/gal EC) vae are actively feeding.
0.75 Ib/A Use limited to AZ, CA and NV.
(50% UP) Foliar application. Apply when lar-
vae are actively feeding.
0.75 Ib/A Use limited to AZ, CA and NV.
(50% WP) Foliar application. Tank mix with
dimethoate.
1 Ib/A Use limited to areas other than AZ,
(50% WP) CA and NV.
Foliar application. Tank mix with
dimethoate.
0.1 ppm (N) (nuts)
10 ppm (almonds, hulls)
30 day preharvest interval through
6 pounds per acre for foliar appli-
cation. For bearing almonds, make
only 1 foliar application per sea-
son.
Foliar application. Apply as a full
cover spray when Infestation starts.
0.5 lb/100
gal
[max 3 Ib/A]
(50% WP)
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment.
Tank mix with a suitable horticul-
tural oil.
Issued: 7-22-85
III-059201-4
-------
/fi/iOOlAA
TPACA:'A
IOBMAOA
FIBULA
[TAi'i'A.;LA
[I.AVA.'.A
ITBCBSA
ITAXAIA
IUBPAZA
ITBUAVA
ITBUALA
IMASAVA
ITBUAPA
IRACBQA
IQAMATA
ILAVBEA
EPA Compendium of Acceptable Uses
N-CKKRCAPTOMETlfYDPHTHALIKIDE S-(0,0-DIKETHYL PHOSPHORODITHIOATE)
Site and Peat
Dosages and Tolerance, Use, Limitations
Apple ,-ipMd
Applo maggot
Cod] Inp raoth
Elm spanworm
f European red rriite)
r^u< 1 1 roe ]r..-:r-
roller
Green frultworm
Gypsy moth
Japanese beetle
Obliquebanded leaf-
roller
Orange tortrlx
Plum curculio
Redbanded leaf-
roller
Rosy apple aphid
(Tarnished plant
bug)
(Twospotted spider
mite)
0.5-0.75 lb/
]00 gal
frvrx 4 Th //•/
c
j OA , 7 O/!
10 ppm
7 dsv s re1" -? rv_-st Ir. ••^'•val tv>rou?v i
pounds per acre for foliar applica-
tion.
Foliar application. Apply as a full
cover spray. For heavy infestations
ijse the higher rat1ATA
ITAPABA
ITBUBJA
Apple aphid
Apple maggot
Codling moth
Elm spanworm
European red mite
Fruittree leaf-
roller
Green fruitworm
Gypsy moth
Japanese beetle
Obliquebanded leaf-
roller
Orange tortrix
Plum curculio
Redbanded leaf-
roller
Redhuraped cater-
pillar
Rosy apple aphid
Tarnished plant bug
Tentiform leafminer
Tufted apple bud
moth
0.25-0.5 lb/
100 gal
[350-400
gal/A]
(50% UP)
Use limited to the northeast.
Foliar application. Do not apply
to early Macintosh or Wealthy
varieties. Repeat as needed.
TanV. mix with nethomyl.
Issued: 7-22-85
III-059201-5
-------
ILA VBEA
IRAFB/U
IRAilBYA
[RAFBAA
/05001AA
IOBMAQA
ILAVASA
ITBUCJA
TTAMABA
INASAVA
ITBUAPA
ILAVBEA
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Apple (continued)
Pest list continued from previous page.
Twospotted spider
raite
White apple leaf-
hopper
San Jose scale 0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
White apple leaf-
hopper
Apricot
Apple maggot
(European red mite)
Oriental fruit moth
Peach twig borer
Plum curculio
Redbanded leaf-
roller
(Twospotted spider
mite)
0.525-0.7 lb/ Use limited to MI.
100 gal Foliar application.
(70% WP) pyrethrins.
Tank mix with
0.5-0.75 lb/
100 gal
[max 3.15
Ib/A]
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
or
0.083-0.125
oz#/gal
(12.5% EC)**
0.45 tbls
actual*/gal
(7.5% WP)
5 ppm
14 day preharvest interval through
3.15 pounds per acre for foliar ap-
plication.
Foliar application. Apply as a full
cover spray. For heavy infestations
use the higher dosage rate. Repeat
as needed. Usually suppresses Euro-
pean red mite and twospotted spider
mite when used in a seasonal pro-
gram.
Delayed dormant and foliar applica-
tion.
Formulated with captan.
Issued: 7-22-85
III-059201-6
-------
EPA Compendium of Acceptable Uses
N-(MERGAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
ITAItABA
:RAKBYA
Site and Pest
Apricot (continued)
Peach twig borer
San Jose scale
'01009AA
Blueberry
Dosages and Tolerance, Use, Limitations
Formulat ion( s'i
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% UP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
10 ppra
3 dav preharvest interval through 1
pound per acre for foliar applica-
tion.
IOBMAPA
ITBMAGA
INASAVA
/05002AA
Blueberry maggot i lb/150-200 Use limited to the Northeastern
IOBMALA
ILAVASA
INBUAGA
INBPAZA
ITAMABA
INASAVA
ILAVBEA
Cranberry fruitworm
Plum curculio
Cherry, Sour (Tart)
Cherry fruit fly
(European red mite)
Fruittree leaf-
roller
Japanese beetle
Peach twig borer
Plum curculio
(Twospotted spider
mite)
gal/A United States.
(50% UP) Foliar application. A second ap-
plication may be made when indicated
by insect infestations and local or
state spray programs.
10 ppm (cherries)
7 day preharvest interval through
1.75 pounds per acre for foliar ap-
plication.
Foliar application. Apply as a full
cover spray. Repeat as needed. For
cherry fruit fly, fruittree leaf-
roller, and plum curculio in the
Northeast. Usually suppresses Euro-
pean red mite and twospotted spider
mite when used in a seasonal pro-
gram.
0.5-0.525 lb/
100 gal
[max 1.75
Ib/A]
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
0.45-0.72 lb/ Delayed dormant and foliar applica-
gal tion.
(7.5%, 12% Formulated with captan or zineb and
WP) captan.
Issued: 7-22-85
III-059201-7
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulat!on(s)
LTAMABA
:RAKBYA
Cherry, Sour (Tart) (continued)
Peach twig borer 0.5-0.525 lb/ Use limited to the Pacific Coast
San Jose scale 100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
''0200GAA
Citrus Fruits (foliar treatment)
'28005AA
Corn
LNAMBHJ
Corn rootworms
(adult)
5 ppm (citrus fruit)
This use occurs on Special Local
Need (24-C) labeling. Refer to ap-
propriate labeling for use informa-
tion and limitations.
0.5 ppm (corn, fresh (inc. sweet
K+CV7HR)
0.5 ppm (corn, grain)
10 ppm (corn, fodder)
10 ppm (corn, forage)
14 day preharvest Interval through
0.5 pound per acre for foliar appli-
cation.
0.25-0.5 Ib/A Use limited to the Corn Belt.
(50% WP) Foliar application. Apply In 2 to
5 gallons of water per acre by air-
craft and in 20 to 50 gallons of
water per acre by ground equipment.
Apply when beetles are present in
sufficient numbers to warrant treat-
ment for protection of the silk from
adult feeding.
Issued: 7-22-85
III-059201-8
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
/28007AA
Site and Pest
Cotton
[WAS AHA
Boll weevil
Dosages and Tolerance, Use, Limitations
Formulatton(s)
0.1 ppm (cottonseed)
0.2 ppm (cottonseed oil)
21 day preharvest interval through
1 pound per acre for foliar applica-
tion.
Do not apply more than 10 pounds per
acre per season.
Do not graze or feed forage to live-
stock.
Do not apply in Claiborne and Copiah
counties, MS; Lauderdale and Madison
counties, AL; and Laurence county,
TN.
Do not apply within 1 mile of any
coastal or estuarine waters. Do not
apply within 100 feet of other aqua-
tic habitats.
0.5 Ib/A
[3-5 gal/A
by aircraft]
or
0.25-0.5 Ib/A
[5-20 gal/A
by ground
equipment]
(50% WP)
0.75-1 Ib/A
(50% WP)
Use limited to areas other than the
San Joaquin Valley, CA.
Foliar application. Apply to over-
wintering generations. Make the
first application at the one-third
square stage and the second appli-
cation 5 to 7 days later. When ap-
plying by ground equipment, use the
higher rate for heavy infestations.
Use limited to areas other than the
San Joaquine Valley, CA.
Foliar application. Apply in 3 to
5 gallons of water per acre by air-
craft and in 5 to 20 gallons of
water by acre by ground equipment.
For first, second, and third genera-
tion, apply at 3 to 7 day intervals
depending upon weevil populations
and weevil migration. Use the high-
er rate for heavy infestations.
Check infestations regularly.
Issued: 7-22-85
III-059201-9
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
/010UAA
Grapes
ITBUCWA
IRAFAOA
IKBPAZA
Grape berry moth
Grape leafhopper
Japanese beetle
ITBMATA
ITBUBCA
Grape leaffolder
Omnivorous leaf-
roller
Dosages and Tolerance, Use, Limitations
Formulation1' s)
10 ppm
7 day preharvest interval through
1.5 pounds per acre (dust) or 1
pound per acre (wettable powder) for
foliar application.
14 day preharvest interval through
1.5 pounds per acre (wettable pow-
der) for foliar application.
Do not apply when fruit or cover
crops are in bloom.
Spray or dust both sides of each
row and spray the tops of the vines
for thorough coverage.
1-1.5 lb/200 Delayed dormant and foliar applica-
gal/A tion. For use in the east. For
(50%, 70% WP) grape berry moth, apply prebloom,
postbloom, first, and later cover
sprays, as needed. For grape leaf-
hopper, apply when most nymphs hatch
(generally coincides with grape
berry moth). For Japanese beetle,
use the higher rate.
or
0.375 tbls
actual*/gal
(12.5% WP)
1.5 Ib/A Use limited to CA.
(5% D) Foliar application. Apply between
egg hatch and pupation.
1 lb/200 Foliar application. For use in the
gal/A west. Apply between egg hatch and
(50%, 70% WP) pupation.
or
0.375 tbls
actual*/gal
(12.5% WP)
0.45-0.6 tbls Delayed dormant and foliar applica-
actual*/gal tion.
(7.5%, 12% Formulated with captan or zineb and
WP) captan.
/06018AA
Kiwi Fruit (soil treatment)
25 ppm
This use occurs on Special Local
Need (24-C) labeling. Refer to ap-
propriate labeling for use informa-
tion and limitations.
Issued: 7-22-85
111-059201-10
-------
/020G4AA
/02006AA
IRAHAGA
IRAKAZA
/05003AA
IOBMAQA
ILAVASA
ITBUCJA
ITAMABA
INASAVA
ITBUAPA
ILAVBEA
ITAMABA
IRAKBYA
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Lemon
Orange
Dosages and Tolerance, Use, Limitations
Formulation( s1)
5 ppm (citrus fruits)
7 day preharvest interval through
15 pounds per acre for foliar appli-
cation.
Do not make more than 3 applications
per season.
Brown soft scale
California red
scale
0.5 lb/100
gal
[max 15
1VA]
(50% VIP)
Nectarines
Apple maggot
(European red mite)
Oriental fruit moth
Peach twig borer
Plum curculio
Redbanded leaf-
roller
(Twospotted spider
mite)
0.5-0.75 lb/
100 gal
[max 3 Ib/A]
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
or
0.083-0.125
oz///gal
(12.5% EC)**
0.45 tblB
actual*/gal
(7.5% WP)
Peach twig borer
San Jose scale
Use limited to AZ, CA, and TX.
Foliar application. Apply as a full
cover spray. Hake up to 3 applica-
tions per season. Allow 30 days
between applications. Tank mix with
a suitable horticultural spray oil.
5 ppm
14 day preharvest interval through
3 pounds per acre for foliar appli-
cation.
Do not tank mix with propargite on
late maturing nectarines as fruit
injury may result.
Foliar application. Apply as a full
cover spray. For heavy infestations
use the higher rate. Repeat as
needed. Usually suppresses European
red mite and twoapotted spider mite
when used in a seasonal program.
Delayed dormant and foliar applica-
tion.
Formulated with captan.
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
Orange
Issued: 7-22-85
See Lemon cluster.
III-059201-11
-------
/OSOO^AA
EPA Compendium of Acceptable Uses
N-(MERCAPTOIIETHYL)PHTHALD1IDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Peach
Dosages and Tolerance, Use, Limitations
ForTr.ulP.t: ion'' s ^
10 ppm
1- day preharvest interval through
3 pounds per acre for foliar appli-
cation.
ILAVASA
INBPAZA
ITBUCJA
ITAMABA
IN'ASAVA
IQAM.ATA
ILAVBEA
ITAMABA
IRAKBYA
/04003AA
IRACAUA
ITBUCSA
ITANAHA
ILAVASA
INBUAGA
ITAXAIA
IRAXALA
INASAVA
ITBUAPA
IRACBOA
(European red mite)
Japanese beetle
Oriental fruit moth
Peach twig borer
Plum curculio
Tarnished riant bug
(Twospotted spider
mite)
Peach twig borer
San Jose scale
Pear
Apple aphid
Codling moth
Elm spanworm
(European red mite)
Fruittree leaf-
roller
Gypsy moth
Pear psylla
Plum curculio
Redbanded leaf-
roller
Rosy apple aphid
Foliar application. Apply as a full
cover spray. For heavy infestations
use the higher rate. Tlepeat as
needed. Usually suppresses European
red mite and twospotted spider mite
wher used in a seasonal program.
Do not use emulsifiable concentrate
on peaches that are to be dried.
0.5-0.75 lb/
100 gal
[max 3 Ib/A]
(50", 70J; WP)
or
0.375-1 this •'
gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
or
0.083-0.125
oz///gal
(12.5% EC)**
0.45-0.6 tbls Delayed dormant and foliar applica-
actual*/gal tion.
(7.5%, 12% Formulated with captan or zineb and
WP) captan.
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
10 ppm
7 day preharvest interval through 5
pounds per acre for foliar applica-
tion.
0.5-0.75 lb/
100 gal
[max 5 Ib/A]
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5% EC)**
or
Foliar application. Apply as a full
cover spray. For heavy infestations
use the higher dosage rate. Repeat
as needed. Usually suppresses Euro-
pean red mite and twospotted spider
mite when used in a seasonal pro-
gram. For elm spanworm, gypsy moth,
and fruittree leafroller in the
Northeast.
Issued: 7-22-85
111-059201-12
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DH-ffiTHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
FormulationC s)
IQAMATA
ILAVBEA
?eai (continued)
Pest list continued from previous page.
(Tarnished plant 0.083-0.125
bug) oz#/gal
(Twospotted spider (12.5% EC)**
mite)
0.45-0.6 tbls Delayed dormant and foliar applica-
actual*/gal tion.
(7.5', 12* Fornulated with cap tan or zineb an I
EC) captan.
IRAKBYA
San Jose scale
/28016AA
Peas
INASDPA
INAGADA
Pea leaf weevil
Pea weevil
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
0.5 ppm (peas)
10 ppm (peas, forage)
10 ppm (peas, hay)
7 day preharvest/pregrazing interval
through 1 pound per acre for foliar
application (peas and peas, forage).
10 day preharvest interval through
1 pound per acre for foliar applica-
tion (peas, hay).
0.75-1 Ib/A
(50% UP)
Use limited to the Pacific Northwest
states.
Foliar application. Apply in 5 to
10 gallons of water per acre by air-
craft and in 20 to 50 gallons of
water per acre by ground equipment.
Apply between emergence and early
pod formation when adult populations
are present but before eggs are
laid.
Issued: 7-22-85
111-059201-13
-------
/05005AA
/05004AA
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIKIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation^ s')
^ecan
HicV.ory shuckvorm
Pecan nuc case-
bearer
Pecan vee-il
Q.75 lb/100
gal
0.1 ppm (N) vnuts)
14 day rreharvest interval through
0.75 pound per 100 gallons for foli-
ar application.
Do not graze livestock on cover
crops grown in treated pecan groves.
Foliar application. Apply as a f'^11
cover spray when infestation starts.
Repeat as needed. For pecar. weevil,
repeat 2t 7 day intervals. ~or
pecan nut casebearer in TX.
5 pptn (plums (fresh prunes))
7 day preharvest interval through 3
pounds per acre for foliar applica-
tion.
IOBMACA
ITBUCSA
ILAVASA
ITBCCJA
ITAMABA
INASAVA
ITBDAPA
ITBDAIA
ILAVBEA
ITBUCSA
ITAMABA
IRAKBYA
Apple maggot
Codling moth
(European red mite)
Oriental fruit moth
Peach twig borer
Plum curculio
Redbanded leaf-
roller
Redhumped cater-
pillar
(Twospotted spider
mite)
Codling moth
Peach twig borer
San Jose scale
Foliar application. Apply as a full
cover spray. For heavy infestations
use the higher rate. Repeat as
needed. Usually suppresses European
red mite and twospotted spider mite
when used in a seasonal program.
0.5-0.75 lb/
100 gal
[max 3 Ib/A]
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
or
0.083-0.125
oz#/gal
(12.5% EC)**
0.45-0.6 tbls Delayed dormant and foliar applica-
actual*/gal tion.
(7.5%, 12% Formulated with captan or zineb and
WP) captan.
0.5 lb/100 Foliar application. Apply by ground
gal equipment. For use in CA.
[max 3 Ib/A]
(50% WP)
0.5-0.525 lb/ Use limited to the Pacific Coast
100 gal States.
(50%, 70% WP) Delayed dormant application. Apply
for thorough coverage by ground
equipment. Tank mix with a suitable
horticultural oil.
Issued: 7-22-85
111-059201-14
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
/14CI5AA
IXAKC:A
IMA";? A
INAMCFA
IRAFAJA
Potato
Colorado potato
beetle
Poir-ito flea beetle
Colorado potato
beetle
Potato flea beetle
Potato leafhopper
Dosages and Tolerance, Use, Limitations
Fonnulatlor.' ?*>
0.1 ppm
7 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Use limited to areas other than CA.
Apply in sufficient water for thor-
ough coverage.
0./5-1 Ib/A Foliar application. For use in the
Northeast.
(50% WP)
Prune
1 Ib/A Foliar application.
(50%, 70% WP)
See Plum cluster.
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
/30005AA
Christmas Tree Plantations
/30097AA
/30104AA
/30135AA
Loblolly Pine (seedlings)
Slash Pine (seedlings)
White Pines (seedlings)
INASBRA
INASCVA
Pales weevil
Pitch-eating weevil
4% top dip
[5 gal/
10,000
seedlings]
(50%, 70% WP)
This use occurs on Special Local
Need (24-C) labeling. Refer to ap-
propriate labeling for use informa-
tion and limitations.
Wear rubber gloves during treating
and planting. Some slight needle
burn and first year growth reduction
may occur following treatment to
loblolly pine.
Foliar application. Dip treatment
down to and including the root col-
lar only. Avoid coverage of roots.
Dip loose enough to allow the sus-
pension to penetrate the bundles.
Swish the tops for 10 to 15 seconds.
Drain and allow the seedlings to dry
before planting. The addition of
an extender may help under high
rainfall conditions.
Issued: 7-22-85
111-059201-15
-------
,'35u _.-AA
/3Anr .~ «,_•_
/630C.-.JA
IRAC: -_a
IRAC3"A
~S..\r.<~" '
TRACE L* A
ISBEA.'3
ILAVASA
IRAWAAA
IRAZALA
TNBUAGA
ITCHADA
ILAVBEA
ITAUAEA
INAMDAC
ITANAHA
ITAXAIA
INBPAZA
ITBDAIA
ITANAVA
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation/' s)
Ornamental and/or Shade Trees
Ornamental Shrubs ("boose B cool calm period, r-refera-
bly in the early morning or evening.
Do not apply if rain is expected or
before plant surfaces are dry. Do
not use on Washington hawthorne.
0.25-0.5 lb/ Foliar application. Apply ror thor-
Anl*5 aphid
f-eecM blight aphid
;!aple aphids
- : : - -r'.id?
Woolly apple aphid
Birch leafminer
European red mite
Mealybugs
Pine bark adelgid
Fruittree leaf-
roller
Mimosa webworm
Twospotted spider
mite
Birch leafminer
Eastern tent cater-
pillar
Elm leaf beetle
(larvae)
Elm spanworm
Gypsy moth
Japanese beetle
Redhumped cater-
pillar
Spring cankerworm
100 gal
or
50 Sal by
mist blower
or
0.042-0.083
oz#/gal
(1 Ib/gal EC)
0.5 lb/100
gal
or
50 gal by
mist blower
or
0.042 oz/gal
(1 Ib/gal EC)
0.75 lb/100
gal
or
50 gal by
mist blower
or
0.125 oz#/gal
(1 Ib/gal EC)
0.5-0.75 lb/
100 gal
(50%, 70% WP)
or
0.375-1 tbls
actual*/gal
[max 10 gal/
tree]
(12.5%, 50%
WP)
ough coverage when pests first ap-
pear. Spreader-stickers nay be
Foliar application. Apply for thor-
ough coverage. For heavy infesta-
tions use the higher rate. For
birch leafminer, elm spanworm, gypsy
moth, and spring cankerworm in the
northeast. Repeat as needed.
Issued: 7-22-85
111-059201-16
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
T l»i"J u -*A
ITA:;ACA
IT AS A LA
ITA'JAGA
ITANAVA
/30124AA
ITBUDDA
/680000A
ISASAYA
Dosages and Tolerance, Use, Limitations
Formulation(?)
Grn.vnental and/or Shade Trees cluster (contii'ued)
0.5-0.75 lb/
100 gal
or
50 gal by
mist blower
or
0.083-0.125
02r/gal
ulc. leaf beetle
Elrr. spanworm
Fall cankerworm
Fall webworm
Forest tent cater
pillar
-vps" noth
J^rariese beetle
'-•:~.r--d-will
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
/14018EA
INASBGA
INDOOR
(Agricultural Crops)
Sweet Potato
Sweet potato weevil 0.1-0.2 oz/
50 Ib
(5% D)
10 ppm
Wash sweet potatoes in clean water
before marketing.
Stored commodity treatment. Make 1
application as soon as possible be-
fore storage. Thoroughly cover all
surfaces using suitable dusting
equipment.
(Pets and Domestic Animals)
(Animals and Their Han-Made Premises)
General Warnings and Limitations: Applicators must wear long sleeved
shirt, long pants, elbow length waterproof gloves, waterproof apron, and
unlined waterproof boots.
/53001IA
Beef Cattle
0.2 ppm (cattle (fat, meat, and meat
byproducts))
21 day preslaughter interval for 5
percent animal dust bag treatment;
0.04 ounce per animal for animal
dust treatment; 2.5 pounds per 100
gallons animal dip treatment (0.24
to 0.3 percent dip replenishment);
1 gallon per animal, 0.25 percent
animal spray treatment; and 1 fluid
ounce of 6 percent animal pour on
treatment per 100 pounds of body-
weight.
3 day preslaughter interval through
0.5 pound per 100 gallons animal
dip treatment (0.03 to 0.06 percent
dip replenishment) and 1.25 pounds
per 100 gallons spray.
Do not treat sick or debilitated
animals. Place a board baffle be-
hind the dust bags if they are used
near feed or water. Do not use
within a few days before or after
treatment with or exposure to cho-
linesterase inhibiting drugs, pesti-
cides or chemicals. Be sure free
access to drinking water is avail-
able to cattle prior to dipping.
Do not dip animals that are over-
Issued: 7-22-85
111-059201-18
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOKETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance8 Use, Limitations
Formulation(s)
Beef Cattle (continued)
IOAWABA
IMAAADA
Cattle grubs*
Lice
IOAWABA
ILAMAGA
IOAUADA
IMAAADA
ILAMAHA
Cattle grubs*
Cattle tick
Horn fly
Lice
Southern cattle
tick
heated. Do not treat calves less
than 3 months of age, except in
federal eradication programs. Hand
dipping of young animals will pre-
vent the animal from swallowing the
dip emulsion.
6% pour on Animal pour on treatment. Apply
[1 fl.oz/100 down the center line of the animals'
Ib body- back. For cattle grubs, treat as
weight] soon as possible after the heel fly
(1 Ib/gal EC) season, before the grub larvae reach
the gullet or spinal canal. Rapid
kill of large numbers of larvae in
these tissues may cause toxic side
effects such as bloat, salivation,
staggering and paralysis. Treat for
other pests any time of the year ex-
cept when cattle grubs are in the
gullet or spinal canal. Repeat at
7 to 10 day intervals as needed.
0.25% spray
[1 gal/ani-
mal and pro-
portionately
smaller
quantities
for younger
animals]
(1 Ib/gal EC)
Animal spray treatment. Apply with
a high pressure spray, taking care
to wet the skin. Apply to the point
of runoff. For cattle grubs, treat
as soon as possible after the heel
fly season, before the grub larvae
reach the gullet or spinal canal.
Rapid kill of large numbers of lar-
vae in these tissues may cause toxic
side effects such as bloat, saliva-
tion, staggering and paralysis.
Treat for other pests any time of
the year except when cattle grubs
are in the gullet or spinal canal.
Repeat at 7 to 10 day intervals as
needed.
Issued: 7-22-85
111-059201-19
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHAL,IMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Beef Cattle (continued)
IOAUABA
ILAMAGA
ILASADA
IMAAADA
ILAMAHA
Cattle grubs*
Cattle tick
Itch mite
Lice
Southern cattle
tick
IOAUAEA
IOAUADA
(Tace fly)
Horn fly
IOAUAEA
IOAUADA
IMAAADA
(Face fly)
Horn fly
Lice
0.2% dip Animal dip treatment. Add super
and phosphate to control the pH of the
0.24% dip re- emulsion. For cattle grubs, treat
plenishment as soon as possible after the heel
(1 Ib/gal EC) fly season, before the grub larvae
reach the gullet or spinal canal.
Rapid kill of large numbers of lar-
vae in these tissues may cause toxic
side effects such as bloat, saliva-
tion, staggering and paralysis.
Treat for other pests any time of
the year except when cattle grubs
are in the gullet or spinal (banal.
Repeat at 7 to 10 day intervals a«
needed. Replenish the dip each time
the vat's volume is reduced by 0.25
of its initial volume. Change the
vat dip emulsion each time 1 of the
following occurs: 1) when the vat
has been charged for 60 daysj 2)
when dip becomes too foujj 3) if the
number of animals dipped equals the
number of gallons In, the initial
volume,
O.OJ. pz/a4ult Animal dust treatment. Apply to
animal act! upper portions of back, neck, and
proportion-- poll. Rub in lightly. Repeat as
ate^ly small- needed.
er quant i--
ties for
younger ani-
mals]
(1% D)
dust bag Animal dust bag treatment. Forced
(1% D) Use; Put dust in dust bags and hang
in barn door exits or alleyways
leading from animal buildings. Hang
near salt or mineral blocks or
watering holes. Protect dust bags
from weather. Free Choice Use;
Place dust bags in loafing sheds,
holding pens, feedlots, near water-
ing holes or other areas where cat-
tle gather.
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Beef Cattle (continued)
IOAUADA
Horn fly
IMAAADA
Lice
/54002IA
Cats
IMNAAAA
ILAAACA
Fleas
Ticks
dust bag Animal dust bag treatment. Suspend
(5% D) dust bags near salt boxes, loafing
sheds or near feed and water facili-
ties. For mandatory use, suspend
dust bags across a gate between pas-
ture and water or between pasture
and feeding areas. Hang the dust
bags at a height so that the lower
portions hit the head, shoulders,
and backline of the animal.
0.005 oz/100 Animal dust treatment. Apply to
Ib body-
weight
[max 0.04
oz/animal]
(1% D)
upper portions of back, neck, and
poll. Rub in lightly. Repeat as
needed.
* - The use of phosmet to control
cattle grubs is considered a new
animal drug use requiring a new
animal drug application with FDA.
This use is no longer regulated by
EPA.
Refer to Dairy Cattle (non-lactating) for addi-
tional use and limitation information.
Improper dilution of emulsifiable
concentrate dip can cause serious
injury to cats. Do not treat
kittens under 8 weeks of age.
0.5 fl.oz Animal treatment. Dip or sponge on
11.6% EC/gal emulsion until the skin IB wet. Al-
(11.6% EC) low the emulsion to dry on the ani-
mal. Repeat at 7 day intervals as
needed. Controls fleas for up to 9
days and ticks for up to 16 days.
Issued: 7-22.-S5
111-059201-21
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDK S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest Dosages and Tolerance, Usej Limitations
~Formulation(s)
/50001 LA Dairy Cattle (non-lac tat ing)
/53001IA 28 day prefreshening interval
through 2.5 pounds per 100 gallons
dip (0.25 to 0.3 percent dip re-
plenishment) and 1.25 pounds per
100 gallons spray. If freshening
should occur within the 28 day pe-
riod after treatment, that milk must
be destroyed. Do not apply to ani-
mals simultaneously or within a few
days before or after treatment with
or exposure to cholinesterase in-
hibiting drugs, pesticides, or chem-
icals. Consult a veterinarian at
the first sign of adverse reaction.
Do not treat sick, convalescent, or
stressed animals or calves less than
3 months old. Be sure free access
to drinking water is available to
cattle prior to dipping. Do not
dip excessively thirsty or over-
heated animals. Following dipping,
allow animals adequate space and
ventilation to thoroughly dry. Do
not allow animals to become crowded
or overheated. Although claims for
cattle grubs are not made for the 5
pound per gallon flowable concen-
trate formulation, it is important
to treat cattle before or after gruh
larvae are in the gullet or spinal
canal. Killing of larvae in these
tissues may cause host-parasite
reactions such as bloat, salivation,
staggering, and paralysis. Consult
a veterinarian, extension livestock
specialist, or extension entomolo-
gist regarding timing of treatment
to avoid host-parasite reactions.
DIP VAT PROCEDURE. Prior to charg-
ing the vat, empty out the old con-
tents and thoroughly clean the vat.
Add water and mix the desired dilu-
tion thoroughly with a compressed
air device or other suitable means.
Restir vat contents prior to each
use.
DIP VAT REPLENISHMENT. During the
dipping operation, each time the
vat's volume is reduced by 12.5 to
Issued: 7-22-85 111-059201-22
-------
EPA Compendium of Acceptable Uses
K-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DXMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Dairy Cattle (non-lactating) (continued)
ILAMAGA
ILAMAHA
Cattle tick
Southern cattle
tick
ILAMAGA
IOAUADA
ILAMADA
Cattle tick
Horn fly
Gulf Coast tick
IMAAADA
Lice
0.5 lb/100
gal dip
and
0.03-0.06%
dip replen-
ishment
(5 Ib/gal
F1C)
0.5 lb/100
gal spray
(5 Ib/gal
F1C)
1.25 lb/100
gal spray
(5 Ib/gal
F1C)
0.83 lb/100
gal spray
(5 Ib/gal
F1C)
25 percent of its initial volume,
replenish the vat at the initial
charge dilution. For evaporation
add additional water accordingly.
For added water due to rainfall,
merely replenish the vat with phos-
met at the initial charge dilution.
If overflow occurs either analyze
for phosmet content and adjust ac-
cordingly or dispose of vat contents
and recharge.
VAT MAINTENANCE. Phosmet concentra-
tion test kits may be used to main-
tain the vat dilution. If no test
kit is available the vat should be
emptied, cleaned, and recharged
each time the following occurs:
1) When the vat has been charged
for 120 days.
2) When the dip becomes too foul.
3) If the number of animals dipped
equals twice the number of gal-
lons of the initial bath volume
within the 120 day limit.
Animal dip treatment.
use.
For general
Animal spray treatment. Apply as a
high pressure spray, taking care to
wet the skin. Apply to the point
of runoff.
Issued: 7-22-85
111-059201-23
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Dairy Cattle (non-lactating) (continued)
ILAMADA
Gulf Coast tick
IOAUADA
Horn fly
ILASADA
Itch mite
B'AAADA
Lice
/54003IA
IMNAAAA
ILASAAA
ILAAACA
Fleas
(Sarcoptc mange
mites)
Ticks
Animal dip treatment. For feedlot
use. Repeat at 7 to 10 day inter-
vals as needed. Treatment for itch
mite may be made any time of the
year except when cattle grub larvae
are in the gullet or spinal canal.
Treatment for itch mite may be made
any time 7 to 10 days following
cattle grub treatment. For control
of itch mite make 2 applications 10
to 14 days apart.
1.25 lb/100
gal dip
and
0.1-0.15% dip
replenish-
ment
(5 Ib/gal
F1C)
0.625 lb/100
gal dip
and
0.06-0.075%
dip replen-
ishment
(5 Ib/gal
F1C)
2.5 lb/100
gal dip
and
0.25-0.3% dip
replenish-
ment
(5 Ib/gal
F1C)
0.83 lb/100
gal dip
and
0.075-0.1%
dip replen-
ishment
(5 Ib/gal
F1C)
Improper dilution of emulsifiable
concentrate dip can cause serious
injury to dogs.
flea collar Animal treatment. Buckle collar
(15% Impr) around dogs' neck. Collar should
be worn losely to prevent irrita-
tion. Allow 2 to 3 fingers between
the collar and neck. Cut off excess
length. When first worn check for
irritation. Remove at the first
Issued: 7-22-85
111-059201-24
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest
Dogs (continued)
IMNAAAA
ILAAACA
Fleas
Ticks (including
American dog tick
and brown dog
tick)
ILASAAA
Sarcoptic mange
mites
Dosages and Tolerance, Use, Limitations
Formulation(s)
sign of irritation. Do not use on
sick or convalescing dogs or puppies
under 12 weeks of age. Remove col-
lar when bathing. Controls fleas
and ticks for up to 7 months and
aids in control for an additional 3
months. Aids in the prevention of
^arcoptic mange mites for up to 8
weeks. Replace when effectiveness
diminishes.
0.025 g/lb of Animal treatment. Apply liberally
bodyweight over the animal beginning at the
(5% D) head and rub thoroughly into the
hair to the skin. Treat legs and
feet and minimize treatment around
the eyes and face. Do not treat
puppies under 12 weeks of age.
Controls fleas for up to 21 days
and ticks for up to 14 days.
1 fl.oz 11.6% Animal treatment. Dip or sponge on
EC/gal emulsion until the skin is wet. Al-
(11.6% EC) low the emulsion to dry on the ani-
mal. Repeat at 7 day intervals as
needed. Do not treat puppies under
8 weeks of age. Controls fleas and
ticks for up to 16 days.
0.025 g/lb Animal treatment. Treat entire dog
bodyweight paying particular attention to in-
(5% D) fected areas and rub thoroughly into
hair to the skin. Make 3 applica-
tions at 7 day intervals. If no
improvement is observed in 21 days,
consult a veterinarian.
1 fl.oz 11.6% Animal treatment. Dip the dog until
EC/gal the skin is wet and allow to shake
(11.6% EC) dry. Do not rinse. If no improve-
ment is seen within 14 days, consult
a veterinarian. If the dog becomes
reinfested, retreatment may be need-
ed.
Issued: 7-22-85
111-059201-25
-------
IMAAATA
EPA Compendium of Acceptable uses
N-(MERCAPTO*ETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Site and Pest Dosages and Tolerance, Use, Limitations
FcmulationC s)
0.2 ppm (hogi (fat, meat, and neat
byprc iucts)
1 day preslaujhter interval through
0.01 ounce per aniaal for animal
dust treatment.
Lice
0.005-0.01 Animal dust treatment. Apply to the
oz/animal backline and lightly rub in. Repeat
(1". D) at 10 to 14 day intervals or as
needed.
9001500
AAAAAAA
9900300
AAAAAM
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
All sites
Tank Mix
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa, Almond, Apple, Apricot,
Cherry Sour (Tart), Lemon, Necta-
rine, Orange, Peach, Pear, Plum,
Prune
Issued: 7-22-85.
111-059201-26
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOHETHYL)PHTHALIMIDE S-(0,0-DIKETHYL PHOSPHORODITHIOATE)
Listing of Registered Pesticide Products by Formulation
°C" technical chsrsical
K-(mercaptomethyi)phthaliraide ;.-(.0, 0-dirae thyl pnosphorodithioate;
(059201)
000476-02178*
*currently unavailable for review
£094.0001 94% technical chemical
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
000476-02177
17 dust
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
002724-00278
&005.0003 5% dust
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
000400-00353 000476-02058 000476-02116 002724-00226
002724-00277 028293-00015
&007.5006 7.5% wettable powder
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201) plus captan (081301)
000226-00249
&012.0006 12% wettable powder
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201), zineb (014506) plus captan (081301)
000842-00109
&012.5006 12.5% wettable powder
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
000476-02161
&050.0006 .50% wettable powder
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
000476-01917 000476-02112 002749-00162** 020954-00014
**suspended
&070.0006 70% wettable powder
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
000476-02158
Issued: 7-22-85
111-059201-27
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Listing of Registered Pesticide Products by Formulation (continued)
&015.0010 15% impregnated materials
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithloate)
(059201)
002724-00279
5.101.0012 1 Ib/gal emulsifiable concentrate
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201) plus aromatic petroleum distillate (006601)
000476-02043* 002724-00169* 002724-00262*
*currently unavailable for review
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201) plus petroleum distillate (063503)
000476-02167 000476-02217
&103.0012 3 Ib/gal emulsiftable concentrate
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201) plus xylene range aromatic solvent (086803)
000476-02033
&211.6012 11.6% emulsifiable concentrate
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
002724-00169
&212.5012 12.5% emulsifiable concentrate
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
010370-00031**
**suspended
S105.0014 5 Ib/gal flowable concentrate
N-(mercaptomethyl)phthalimide S-(0,0-dimethyl phosphorodithioate)
(059201)
002724-00321
Issued: 7-22-85
111-059201-28
-------
EPA Compendium of Acceptable Uses
N-(MERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIMETHYL PHOSPHORODITHIOATE)
Appendix A-l
Listing of Active Ingredient( ?) Found in ConMnation '?ith the Report Che~.'csl:
Chemical Ccmraon Name EPA Acceptable
(source) Common /Chemical Name
006601 — aromatic petroleum distillate
081301 — captan
063503 — petroleum distillate
086803 — xyle-i3 -ange aromatic solvent
014506 — zineb
— Use EPA Acceptable Common /Chemical Name
Issued: 7-22-85 111-059201-29
-------
EPA Compendium of Acceptable Uses
N-(I'ERCAPTOMETHYL)PHTHALIMIDE S-(0,0-DIfETHYL PHOSPHORODITHIOATE)
Appendix A-2
Listing of A:tiv~ Ingredient( s) irhi-h "ay " ; Included in 1j.r.:- J'ixes
Chemical Co—ion Name EPA Acceptable
Code (source) Comaon/Chemical ?Iame
035001 — dimethoate
090301 -- methomyl
065001 — pyrethrias
— Use EPA Acceptable Common/Chemical Name
Issued: 7-22-85 111-059201-30
-------
IV. BIBLIOGRAPHY APPENDICES
-------
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.
-------
BIBGUIDE-2
a. Author. Whenever the 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.
-------
OFFICE OF PESTICIDE PROGRAM
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00046189 McCabe, J.; Howe11, A.; Jones, B.; et al. (1949?) Toxicity Studies
with Rats: T-6304. (Unpublished study received May 20, 1980
under 476-2178; submitted by Stauffer Chemical Co., Richmond,
Calif.r CDL:242478-0)
00046190 Jones, B.; Howell, A.; Barker, L. (1949?) Acute Rabbit Dermal Tox-
icity: T-6304. (Unpublished study received May 20, 1980 under
476-2178; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:242478-E)
00046191 Brookins, M. (1965?) Primary Skin Irritation: T-6304. (Unpublished
study received May 20, 1980 under 476-2178; submitted by Stauf-
fer Chemical Co. , Richmond, Calif.; CDL:242478-F)
00046192 Brookins, M. (1965?) Ocular Irritation: T-6304. (Unpublished study
received May 20, 1980 under 476-2178; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:242478-G)
00053821 Courtney, K.D. (1968) Teratological Investigation in Macaca mu-
latta of Captan, Imidan and Thalidomide. (Unpublished study
including letters dated Jan 10, 1968 from K.D. Courtney to Geof-
frey VJbodard and Jan 12, 1968 from G. Vfoodard to A.B. Lindquist,
received Jul 29, 1970 under unknown admin, no.; prepared by Bio-
netics Research Laboratories, Inc., submitted by Chevron Chemi-
cal Co. , Richmond, Calif.; CDL:107817-L)
00054507 Stauffer Chemical Company (1971) Imidan Environmental Studies.
(Unpublished study received Dec 30, 1976 under 476-EX-73; CDL:
229164-H)
00056850 Stauffer Chemical Company (19??) Frozen Storage Stability of Imidan
on Apple Samples. (Unpublished study received Feb 10, 1964
under 6G0455; CDL:090497-O)
00056851 Stauffer Chemical Company (19??) Storage Stability of Imidan Ex-
tracts of Crop Samples. (Unpublished study received Feb 10,
1964 under 6G0455; CDL:090497-P)
00056852 Stauffer Chemical Company (19??) Efficiency of the Benzene Extrac-
tion Procedure. (Unpublished study received Feb 10, 1964 under
6G0455; CDL:090497-Q)
00056854 Stauffer Chemical Company (19??) Translocation of Imidan in Apples
and Peaches. (Unpublished study received Feb 10, 1964 under
6G0455; CDL:090497-T)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00056858 Stauffer Chemical Conpany (1964) Crop Residue Samples. (Reports
by various sources; unpublished study received on unknown date
under 6G0455; CDL:090497-X)
00056860 Batchelder, G.H.; O'Connor, M. (1965) Imidan Residue Data from
Cattle Feeding Study at UC, Davis, RR-65-84. (Unpublished study
received on unknown date under 6G0455; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:090497-Z)
00056862 Batchelder, G.H.; O'Connor, M. (1965) Imidan Residue Data from
Cattle Spray Study at USDA, Corvallis: RR-65-83. (Unpublished
study received on unknown date under 6G0455; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:090497-AB)
00056864 Ford, I.M. (1964) The Metabolism of Imidan C-14 in the Rat: Report
No. 481. (Unpublished study received Feb 10, 1964 under 6G0455;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:
090497-AE)
00056865 Ford, I.M.; Menn, J.J.; Meyding, G.D (1965) Metabolism of C14 N-
(Mercaptomethy 1) Phthal inri.de S- (0,0-Dimethylphosphorodithioate)
(Imidan): Part I: Balance Study in the Rat. (Unpublished study
received on unknown date under 6G0455; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:090497-AF)
00056866 Msnn, J.J.; McBain, J.B.; Adelson, B.J; et al. (1964) Degradation
of N-(niercaptcnethyl)phthalimide-S-(O,O-dimethyl) phosphoro-
dithioate) (Imidan) in Soils. (Unpublished study received
Feb 10, 1964 under 6G0455; submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL:090497-AG)
00060625 Johansen, C.; Hutt, R. (1962) Bee Poisoning Investigations, 1962:
Report No. 10617. (Unpublished study received Mar 27, 1974 un-
der 4F1485; prepared by Washington State Univ., submitted by
Chemagro Corp., Kansas City, Mo.; CDL:092011-E)
00061721 Stauffer Chemical Company (1976) Summary of Crop Residue Data for
Imidan on Dry Pea Hay. (Compilation; unpublished study received
Jun 29, 1976 under 476-1917; CDL-.228288-A)
00062648 Fabro, S.; Smith, R.L.; Williams, R.T. (1965?) Embryotoxic Activity
of Some Pesticides and Drugs Related to Phthalimide. (Unpub-
lished study received Sep 20, 1967 under unknown admin, no.;
prepared by St. Mary's Hospital Medical School, Dept. of Bio-
Chemistry, England, submitted by Stauffer Chemical Co., Rich-
mond, Calif.; CDL:140130-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00062649 Kidwell, C; Holme, I.; Horn, H. J,; et al. (1966) Imidan: Oral Com-
pared to Derml Administration to the Ifebbits Effect on Repro-
duction. (Unpublished study received Sep 20, 1967 under un-
known admin, no.; prepared by Wbodard Research Corp., submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:140130-C)
00063192 Staples, R.E.; Kellam, R.G; Haseman, J.K. (1976) Developmental
toxicity in the rat after ingestion of gavage of organophosphate
pesticides (Dipterex, Imidan) during pregnancy. Environmental
Health Perspectives 13(Feb) 1133-140. (Also in unpublished
submission received Apr 18, 1978 under 476-1917; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:234110-O)
00063193 Sanders, H.O. (1972) Toxicity of Some Insecticides to Four Species
of Malacostracan Crustaceans. By U.S. Fish and Wildlife Serv-
ice, Fish-Pesticide Research Laboratory. Washington, D.C.:
USFWS. (Technical Papers 66; published study; CDL:234110-E)
00063194 Julin, A.M.; Sanders, H.O. (1977) Toxicity and accumulation of the
insecticide Imidan in freshwater invertebrates and fishes.
Transactions of the American Fisheries Society 106(4):386-392.
(Also in unpublished submission received Apr 18, 1976 under
476-1917; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:234110-F)
00063195 Castles, T.R.; Howell, A.; Jones, B.; et al. (1977) Toxicity
Evaluation: Toxicology Laboratory Report T-6123. (Unpublished
study received Apr 18, 1978 under 476-1917; submitted by Stauf-
fer Chemical Co., Richmond, Calif.; CDL:234110-H)
00063196 Dean, W.P. (1977) Acute Toxicity Studies in Rabbits and Rats:
Study No. 153-051. (Unpublished study received Apr 18, 1978
under 476-1917; prepared by International Research and Develop-
ment Corp., submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:234110-1)
00063197 Leong, B.K.J. (1977) Acute Inhalation Toxicity Study in Albino
Rats—Saturated Atmosphere: Study No. 153-051. (Unpublished
study received Apr 18, 1978 under 476-1917; prepared by Inter-
national Research and Development Corp., submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:234110-^J)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00046189 McCabe, J.; Howe 11, A.; Jones, B.,- et al. (1949?) Toxicity Studies
with Rats: T-6304. (Unpublished study received May 20, 1980
under 476-2178; submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:242478-D)
00046190 Jones, B.; Howell, A.; Barker, L. (1949?) Acute Rabbit Dermal Tox-
icity: T-6304. (Unpublished study received May 20, 1980 under
476-2178; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:242478-E)
00046191 Brookins, M. (1965?) Primary Skin Irritation: T-6304. (Unpublished
study received May 20, 1980 under 476-2178; submitted by Stauf-
fer Chemical Co., Richmond, Calif.; CDL:242478-F)
00046192 Brookins, M. (1965?) Ocular Irritation: T-6304. (Unpublished study
received May 20, 1980 under 476-2178; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:242478-G)
00053821 Courtney, K..D. (1968) Teratological Investigation in Macaca mu-
latta of Captan, Imidan and Thalidomide. (Unpublished study
including letters dated Jan 10, 1968 from K.D. Courtney to Geof-
frey Woodard and Jan 12, 1968 from G. Woodard to A.B. Lindquist,
received Jul 29, 1970 under unknown admin, no.; prepared by Bio-
netics Research Laboratories, Inc., submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:107817-L)
00054507 Stauffer Chemical Company (1971) Imidan Environmental Studies.
(Unpublished study received Dec 30, 1976 under 476-EX-73; CDL:
229164-H)
00056850 Stauffer Chemical Company (19??) Frozen Storage Stability of Imidan
on Apple Samples. (Unpublished study received Feb 10, 1964
under 6G0455; CDL:090497-O)
00056851 Stauffer Chemical Company (19??) Storage Stability of Imidan Ex-
tracts of Crop Samples. (Unpublished study received Feb 10,
1964 under 6G0455; CDL:090497-P)
00056852 Stauffer Chemical Company (19??) Efficiency of the Benzene Extrac-
tion Procedure. (Unpublished study received Feb 10, 1964 under
6G0455; CDL:090497-Q)
00056854 Stauffer Chemical Company (19??) Translocation of Imidan in Apples
and Peaches. (Unpublished study received Feb 10, 1964 under
6G0455; CDL:090497-T)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered Co be Part of the Data Base Supporting
Registrations Under the phosmet Standard
MRID CITATION
00056858 Stauffer Chemical Company (1964) Crop Residue Samples. (Reports
by various sources; unpublished study received on unknown date
under 6G0455; CDL:090497-X)
00056860 Batchelder, G.H.; O'Conno'r, M. (1965) Imidan Residue Data from
Cattle Feeding Study at UC, Davis, RR-65-84. (Unpublished study
received on unknown date under 6G0455; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:090497-Z)
00056862 Batchelder, G.H.; O'Connor, M. (1965) Imidan Residue Data from
Cattle Spray Study at USDA, Corvallis: RR-65-83. ( Unpublished
study received on unknown date under 6G0455; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL.-090497-AB)
00056864 Ford, I.M. (1964) The Metabolism of Imidan C-14 in the Rat: Report
No. 481. (Unpublished study received Feb 10, 1964 under 6G0455;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:
090497-AE)
00056865 Ford, I.M.; Menn, J.J.; Meyding, G.D (1965) Metabolism of C14 N-
( MercaptomethyDPhthalimide S-( O,0-Dimethylphosphorodithioate )
(Imidan): Part I: Balance Study in the Rat. (Unpublished study
received on unknown date under 6G0455; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:090497-AF)
00056866 Menn, J.J.; McBain, J.B.; Adelson, B.J; et al. (1964) Degradation
of N-( mercaptomethyl)phthalimide-S-( O,0-dimethyl) phosphoro-
dithioate) (Imidan) in Soils. (Unpublished study received
Feb 10, 1964 under 6G0455; submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL:090497-AG)
00060625 Johansen, C.; Hutt, R. (1962) Bee Poisoning Investigations, 1962:
Report No. 10617. (Unpublished study received Mar 27, 1974 un-
der 4F1485; prepared by Washington State Univ., submitted by
Chemagro Corp., Kansas City, Mo.; CDL:092011-E)
00061721 Stauffer Chemical Company ( 1976) Summary of Crop Residue Data for
Imidan on Dry Pea Hay. (Compilation; unpublished study received
Jun 29, 1976 under 476-1917; CDL:228288-A)
00062648 Fabro, S.; Smith, R.L.; Williams, R.T. (1965?) Embryotoxic Activity
of Some Pesticides and Drugs Related to Phthalimide. ( Unpub-
lished .study received Sep 20, 1967 under unknown admin, no.;
prepared by St. Mary's Hospital Medical School, Dept. of Bio-
Chemistry, England, submitted by Stauffer Chemical Co., Rich-
mond, Calif.; CDL:140130-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00062649 Kidwell, C; Holme, I.; Horn, H.J.; et al. (1966) Imidan: Oral Com-
pared to Dermal Administration to the Rabbit: Effect on Repro-
duction. (Unpublished study received Sep 20, 1967 under un-
known admin, no.; prepared by Woodard Research Corp., submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:140130-C)
00063192 Staples, R.E.; Kellam, R.G; Haseman, J.K. (1976) Developmental
toxicity in the rat after ingestion of gavage of organophosphate
pesticides (Dipterex, Imidan) during pregnancy. Environmental
Health Perspectives 13(Feb):133-140. (Also in unpublished
submission received Apr 18, 1978 under 476-1917; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:234110-D)
00063193 Sanders, H.O. ( 1972) Toxicity of Some Insecticides to Four Species
of Malacostracan Crustaceans. By U.S. Fish and Wildlife Serv-
ice, Fish-Pesticide Research Laboratory. Washington, D.C.:
USFWS. (Technical Papers 66; published study; CDL:234110-E)
00061 4 Julin, A.M.; Sanders, H.O. (1977) Toxicity and accumulation of the
insecticide Imidan in freshwater invertebrates and fishes.
Transactions of the American Fisheries Society 106(4):386-392.
(Also in unpublished submission received Apr 18, 1976 under
476-1917; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:234110-F)
00063195 Castles, T.R.; Howell, A.; Jones, B.; et al. (1977) Toxicity
Evaluation: Toxicology Laboratory Report T-6123. (Unpublished
study received Apr 18, 1978 under 476-1917; submitted by Stauf-
fer Chemical Co., Richmond, Calif.; CDL:234110-H)
00063196 Dean, W.p. (1977) Acute Toxicity Studies in Rabbits and Rats:
Study No. 153-051. (Unpublished study received Apr 18, 1978
under 476-1917; prepared by International Research and Develop-
ment Corp., submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:234110-I)
00063197 Leong, B.K.J. (1977) Acute Inhalation Toxicity Study in Albino
Rats—Saturated Atmosphere: Study No. 153-051. (Unpublished
study received Apr 18, 1978 under 476-1917; prepared by inter-
national Research and Development Corp., submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:234110-J)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00066220 Atkins, E.L., Jr.; Anderson, LoD. ; Kellum, D.; et al. (1976)
Protecting Honey Bees from Pesticides. ?; Univ. of California,
Div. of Agricultural Sciences. (Leaflet 2883; also in unpub-
lished submission received Mar 20, 1980 under 432-502; sub-
mitted by Penick Corp., Lyndhurst, N.J.; CDL:243536-B)
00067068 Stauffer Chemical Company (1980) Imidan 50-WP on Cottonseed: Summa-
ry of Crop Residue Data. (Compilation; unpublished study re-
ceived Dec 31, 1980 under 476-1917; CDL:244021-B)
00067069 Adelson, B.J.; McKay, J.C.; Schwab, G.W. (1973) Determination of
Residues of Imidan and Imidan Oxygen Analog. Method no.
WRC 73-43 dated Jun 19, 1973. (Unpublished study received Dec
31, 1980 under 476-1917; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:244021-C)
00075425 Fogleman, R.W. (1960) Acute Oral Administration—Rats. (Unpub-
lished study received Apr 8, 1976 under 476-2167; prepared by
Hazleton Laboratories, Inc., submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:233439-B)
00075426 Ford, I.M. (1962) Acute Oral Administration—Rats: Project 20-0240-
32. Final rept. (Unpublished study received Apr 8, 1976 under
476-2167; prepared by Hazleton Nuclear Science Corp., submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL-.233439-C)
00075427 Ford, I.M. (1963) Imidan 323-B: Acute Oral, LD-50--Rats: Report
No. 345. (Unpublished study received Apr 8, 1976 under 476-
2167; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:233439-D)
00075429 Meyding, G.D. (1963) Imidan, Technical: Acute Oral, LD-50—Rats:
Report No. 307. (Unpublished study received Apr 8, 1976 under
476-2167; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:233439-F)
00075433 Meyding, G.D. (1965) Imidan, Technical: Acute Oral Subcutaneous &
Intraperitoneal Toxicity in Rats & Mice: Report No. 65-2. (Un-
published study received Apr 8, 1976 under 476-2167; submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:233439-^J)
00075439 Meyding, G.D. (1960) Acute Dermal Application; Acute Eye Applica-
tion. (Unpublished study received Apr 8, 1976 under 476-2167;
prepared by Hazleton-Nuclear Science Corp., submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:233439-P)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00075996 Stauffer Chemical Conpany (1975) Chemistry of Imidan(R)/Pro-
late. (Conpilation; unpublished study received Apr 20,
1976 under 476-2167; CDL:231210-A)
00076436 Lobdell, B.J.; Johnston, C.D. (1966) Imidan: Safety Evaluation
by Two-year Feeding Studies in the Rat and the Dog. (Unpub-
lished study, including letter dated Jul 21, 1966 from C.D.
Johnston to A.B. Lindquist, received Sep 10, 1966 under 7F0523;
prepared by Wbodard Research Corp., submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:090622-B)
00078567 McGuire, W.C.; McKay, J.; Meyding, G.D. (1969) Stability, Efficacy,
Tissue Residues and Toxicity of Prolate Used in Cattle Dip-
ping Vats. (Unpublished study received Feb 6, 1970 under un-
known admin, no. ; submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:129280-D)
00078568 McKay, J.C. (1969) Letter sent to W. McGuire dated Feb 12, 1969:
Prolate Dip Vat Residue Data. (Unpublished study received Feb
6, 1970 under unknown admin, no.; submitted by Stauffer Chemical
Conpany, Richmond, Calif.; CDL:129280-E)
00078570 Stauffer Chemical Company (1963) Imidan and Prolate Residues in
Dairy Cows. (Conpilation; unpublished study received Feb 6,
1970 under unknown admin, no.; CDL:129280-H)
00080552 Hill, R. (1963) 21 Day Subacute Dermal Toxicity Evaluation: Techni-
cal Report: Lab No. 2H7275. (Unpublished study received Aug 25,
1965 under 7F0523; prepared by Diablo Laboratories, Inc., sub-
mitted by Stauffer Chemical Co., Richmond, Calif.; CDL-.097514-S)
00080554 Meyding, G.D.; Horton, R.J. (1965) Imidan: 21-day Sub-acute Dermal
Toxicity in Rabbits: Richmond Report No. 65-74. (Unpublished
study received Aug 25, 1965 under 7F0523; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL-.097514-U)
00080556 Johnston, C.D. (1963) Imidan: An Evaluation of Safety of Imidan in
the Rat and the Dog: Final Supplement. (Unpublished study re-
ceived Aug 25, 1965 under 7F0523; prepared by Wbodard Research
Corp., submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:097514-Y)
00081426 Johnston, C.D. (1962) Imidan: An Evaluation of Safety of Imidan
in the Rat and the Dog. (Unpublished study received Sep 10,
1965 under 6G0506; prepared by Vfoodard Research Corp., submit-
ted by Stauffer Chemical Co., Richmond, Calif.; CDL:090595-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
ID CITATION
00081429 Johnston, C.D.; Cronin, M.T.I. (1963) Further Evaluation of the
Safety of Imidan in the Rat. (Unpublished study received
Sep 10, 1965 under 6G0506; prepared by Wbodard Research Corp.,
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:
090595-E)
00081431 Johnston, C.D.; Cronin, M.T.I. (1963) Imidan: Demyelination Study
in the Chicken. (Unpublished study received Sep 10, 1965
under 6G0506; prepared by Wbodard Research Corp., submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:090595-H)
00081432 Woodard, G. (1965) Letter sent to C.O. Persing dated May 20, 1965
Three-generation rat reproduction study with Imidan. (Un-
published study received Sep 10,, 1965 under 6G0506; prepared
by Wbodard Research Corp., submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:090595-1)
00081616 Stauffer Chemical Conpany (1981) Summary of Residue Data for Imidan
50-WP on Tomatoes. (Compilation; unpublished study received
Aug 28, 1981 under 1E2565; CDL-.070294-A)
00084808 Bowman, M.C.; Beroza, M. (1966) Determination of Imidan and Imidox-
on in sweet corn by gas chromatography with flame photometric
detection. Journal of the Association of Official Analytical
Chemists 49(6):1154-1157. (Also in unpublished submission re-
ceived 1974 under 4F1464; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:093901-C)
00084809 Stauffer Chemical Company (1973) Summary of Imidan Residue Data for
Blueberries. (Compilation; unpublished study received 1974 un-
der 4F1464; CDL:093901-D)
00084810 Stauffer Chemical Company (1972) Residue of Imidan on Grapefruit,
Lemons and Oranges. (Compilation; unpublished study received
1974 under 4F1464; CDL:093901-E)
00084811 Stauffer Chemical Company (1974) Summary of Imidan Residue Data on
Corn. (Compilation; unpublished study received 1974 under
4F1464; CDL:093901-F)
00084813 Stauffer Chemical Conpany (1973) Residue of Imidan on Almonds,
Filberts, Pecans and Walnuts. (Compilation; unpublished study
received 1974 under 4F1464; CDL:093901-fl)
00084814 Stauffer Chemical Conpany (1973) Sunmary of Imidan Residue Data on
Peas. (Cortpilation; unpublished study received 1974 under
4F1464; CDL:093901-1)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00084815 Mckay, J.C. (1973) Letter sent to R.L. Riggs dated Nbv 30, 1973:
Storage stability of Imidan on blueberries and milo. (Unpub-
lished study received 1974 under 4F1464; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:093901-K)
00087762 Adelson, B.J.; Schwab, G.W. (1973) The Determination of Pro-
late and Prolate Oxygen Analog in Animal Tissues, Milk
and Cream. Method no. WRC 73-10 dated Aug 23, 1973. (Unpub-
lished study received Dec 18, 1981 under 2724-262; prepared by
Stauffer Chemicals, submitted by Zoecon Industries, Inc., Dal-
las, Tex.; CDL:246472-£>)
00093486 Stauffer Chemical Conpany (1966) The Results of Tests on the Amount
and Nature of the Residue, and the Analytical Methodology:
Imidan. (Conpilation; unpublished study received Aug 3, 1966
under 7F0523; CDL:090623-A)
00093487 McBain, J.B.; Menn, J.J. (1966) Fate of C14-N-Mercaptomethyl-
phthalimide S-(0,0-Dimethylphosphorodithioate) (Imidan)
in Water, Rats and Insects. (Unpublished study received Aug 3,
1966 under 7F0523; submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:090623-B)
00094636 Washington (1981) Residues of Imidan in Potatoes. (Compilation;
unpublished study received Feb 16, 1981 under WA 81/58; CDL:
246673-A)
00095485 Stauffer Chemical Company (1968) Residue Summary: Imidan 50WP on
Alfalfa. Includes method dated Apr 24, 1968. (Conpilation;
unpublished study, including FSDS nos. B-0102, B-0104, B-0106
..., received Apr 8, 1969 under 476-1917; CDL:003820-A)
00097846 McKay, J.C. (1972) Letter sent to R.L. Riggs dated May 31, 1972:
Imidan—citrus frozen: Storage stability. (Unpublished study
received 1974 under 4F1464; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:093901-J)
00105999 Fletcher, D.; Jenkins, D.; Thorn, V.; et al. (1982) Report to
Stauffer Chemical Conpany: Toxicity and Reproduction Study
with Imidan Technical in Mallard Ducks: BIAL No. 81 DR 2. (Un-
published study received Jun 21, 1982 under 476-1917; prepared
by Bio-Life Assoc., Ltd., submitted by Stauffer Chemical Co.,
Richmond, CA; CDL:247797-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00106602 Stauffer Chemical Company (1975) Summary of Crop Residue Data Sup-
porting Registration of Captan: Imidan 16:12-WP. (Compilation;
unpublished study received Mar 21, 1975 under 476-2172; CDL:
028453-D)
00109135 Bellies, R.; Scott, W.; Knott, W. (1965) Imidan Safety Evaluation
on Fish and Wildlife (Mallard Ducks, Rainbow Trout). (Unpub-
lished study received Sep 12, 1965 under 6G0506; prepared by
Woodard Research Corp., submitted by Stauffer Chemical Co.,
Richmond, CA; CDL:090593-D)
00109652 Sprague, G. (1982) Acute Delayed Neurotoxicity Study with Imidan
Technical in Adult Hens: T-10910. (Unpublished study received
Aug 16, 1982 under 476-2177; submitted by Stauffer Chemical
Co., Richmond, CA; CDL:071044-A)
00112241 Stauffer Chemical Co. (1970) Prolate: Tissue Residue Studies, Bio-
chemistry and Analytical Methodology. (Compilation; unpublished
study received Feb 12, 1970 under 476-2058; CDL:003895-A)
00112245 Stauffer Chemical Co. (1965) Study: Imidan Residue on Cotton.
(Compilation; unpublished study received on unknown date under
476-1917; CDL-.017095-B)
00112247 Stauffer Chemical Co. (1969) Study: Imidan Residue on Grapes.
(Compilation; unpublished study received Feb 10, 1972 under 476-
2116; CDL:018039-B)
00112249 Stauffer Chemical Co. (1974) Omental Fat Residues from Cattle Dip-
ped in 0.3% Prolate Immersion Vat. (Compilation; unpublished
study received Mar 25, 1974 under 476-2043; CDL-.025567-B)
00112260 Stauffer Chemical Co. (1968) The Results of Tests on the Amount
and Nature of the Residue, and the Analytical Methodology for
... Prolate, Imidan. (Compilation; unpublished study received
Oct 18, 1968 under 9F0769; CDL-.091325-B)
00112262 Interregional Research Project No. 4 (1972) The Results of Tests on
the Amount and Nature of the Residue, and Analytical Methodolo-
gy: Imidan. (Compilation; unpublished study received Dec 23,
1972 under 3E1328; CDL:092272-A)
00112263 Stauffer Chemical Co. (1965) Chemical Study: Imidan. (Ccnpila-
tion; unpublished study received Jun 22, 1966 under 6G0506; CDL:
092792-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00112265 Stauffer Chemical Co. (1967) Study: Imidan Residue in Specific
Crops. (Cortpilation; unpublished study received Feb 27, 1967
under 7F0523; CDL:092810-A)
00112271 Stauffer Chemical Co. (1971) Imidan: Itesidues in Potatoes and
Other Crops. (Compilation; unpublished study received Jan 21,
1971; Dec 9, 1970 under OF0978; CDL:093286-A)
00112274 Adelson, B.; McKay, J. (1972) Determination of Residues of Imidan
and Imidan Oxygen Analog: WRC 72-46. (Unpublished study re-
ceived Oct 25, 1972 under 3E1328; prepared by Stauffer Chemical
Co., submitted by Interregional Research Project No. 4, New
Brunswick, NJ; CDL:093558-A)
00112279 Stauffer Chemical Co. (1978) The Results of Tests on the Amount
and Nature of the Residue, and Analytical Methodology: Imidan.
(Compilation; unpublished study received Aug 2, 1978 under
8E2102; CDL:097256-B)
00112281 Stauffer Chemical Co. (1979) The Results of Tests on the Amount and
Nature of the Residue, and Analytical Methodology: Imidan.
(Compilation; unpublished study received Mar 15, 1979 under 476-
1917; CDL:098023-A)
00112283 Stauffer Chemical Co. (1974) Imidan Residue Data on Specified
Crops. (Compilation; unpublished study received Jan 27, 1975
under 4F1464; CDL:098090-A)
00112288 Ray, D. (1964) Imidan RP4-RCT-116: Acute Oral LD50—Rats: Report
#507. (Unpublished study received on unknown date under 6G0455;
submitted by Stauffer Chemical Co., Richmond, CA; CDL:098119-G)
00112296 Stauffer Chemical Co. (1962) Residue Studies of Specific Pesti-
cides. (Compilation; unpublished study received Mar 5, 1963
under unknown admin, no.; CDL:122546-A)
00112302 Lindquist, A. (1963) Imidan Residue Data. (Unpublished study re-
ceived 1963 under unknown admin, no.; submitted by Stauffer
Chemical Co., Richmond, CA; CDL:125182-A)
00112304 McBain, J.; Hoffman, L.; Menn, J. (1973) Environmental Behavior of
Imidan, ..-: ARC-B-40. (Unpublished study received Jan 2, 1974
under 476-1917; submitted by Stauffer Chemical Co., Richmond,
CA; CDL:131494-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosraet Standard
MR10 CITATION
00112310 Stauffer Chemical Co. (1966) Consolidated Report of Prolate Resi-
due Data. (Compilation; unpublished study received Feb 1, 1966
under unknown admin, no.; CDL:123665-A)
00112312 Mann, J.; McBain, J. (1963) Metabolism of Imidan, a Heterocyclic
Organophosphorus Insecticide in Cotton Plants. (Unpublished
study received May 9, 1963 under unknown admin, no.; submitted
by Stauffer Chemical Co., Richmond, CA; CDL:123666-B)
00112313 Stauffer Chemical Co. (1962) Imidan: Residues in Apples and Other
Crops. (Compilation; unpublished study received Jan 28, 1963
under unknown admin, no.; CDL:123666-C)
00112314 Zoecon Industries, Inc. (1978) Zoecon 1% Phosmet Dust for Control
of Hog Lice. (Compilation; unpublished study received Sep 7,
1978 under 2724-EX-14; CDL:235049-A)
00112316 Stauffer Chemical Co. (1973) Supplemental Application of Prolate
1-E: NADA #44-757. (Compilation; unpublished study received Oct
23, 1973 under 476-2043; CDL.-221950-A)
00112317 Stauffer Chemical Co. (1976) Chemical Study: Imidan Technical:
Project No. 149625. (Compilation; unpublished study received
Nov 16, 1976 under 476-2178; CDL:227419-&)
00112325 Zoecon Industries, Inc. (1978) Starbar GX-118: Chemical Study.
(Compilation; unpublished study received Dec 11, 1978 under
2724-262; CDL:237796-A)
00116855 Stauffer Chemical Co. (1968) The Results of Tests on the Amount and
Nature of the Residue, and Analytical Methodology: Imidan.
(Compilation; unpublished study received on unknown date under
OF0978; CDL:091682-B)
00125786 Fletcher, D.; Jenkins, D.; Debevec, K.; et al. (1982) Report to
Stauffer Chemical Co.: Toxicity and Reproduction Study with
Imidan Technical in Bobwhite Quail: BLAL 1*3. 81 QR 2; Study
T-10817. (Unpublished study received Feb 15, 1983 under 476-
1917; prepared by Bio-Life Assoc., Ltd., submitted by Stauffer
Chemical Co., Richmond, CA; CDL:249520-A)
00126567 Zoecon Industries, Inc. (1983) Chemistry Data: Zoecon RF-224
Phosmet Flowable for Control of Scabies Mite, Cattle Lice and
Hornflies. (Compilation; unpublished study received Mar 3, 1983
under 2724-EX-31; CDL:249788-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosmet Standard
MRID CITATION
00148321 Spillner, C: Cramer, E. (1981) Adsorption and Desorption Studies
of Imidan in Soil: MRC-81-06; MRC-B-113 (PMS-113). Unpublished
study prepared by Stauffer Chemical Co. 29 p.
00148322 Spillner, C.; Cramer, E.; Neuberger, A.; et al. (1982) Mobility of
Imidan and Metabolites in Soil: MRC-82-07; PMS-115. Unpublished
study prepared by Stauffer Chemical Co. 36 p.
00148323 Lesh, M. (1980) Stauffer Chemical Co. Residue Report: FSDS No. A-
13589, 1-8. [Imidan 50-W in Soil]. Unpublished study prepared
by Stauffer Chemical Co. 17 p.
00148324 Lesh, M. (1980) Stauffer Chemical Co. Residue Iteport: FSDS No. A-
17727-31: A-18559: A-18563: A-18148: 50-W]. Unpublished study
prepared by Stauffer Chemical Co. 19 p.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide
residues to four kinds of bees. Environmental Entomology
1(3):393-394.
05004211 Bowman, M.C.; Beroza, M. (1967) Temperature-programmed gas
chromatography of 20 phosphorus-containing insecticides on 4
different columns and its application to the analysis of milk
and corn silage. Journal of the Association of Official
Analytical Chemists 50(6)-.1228-1236.
05009345 Croft, B.A.; Nelson, E.E. (1972) Toxicity of apple orchard
pesticides to Michigan populations of Amblyseius fallacis.
Environmental Entomology 1(5):576-579.
05012698 Johnson, J.C., Jr.; Bowman, M.C. (1968) Fate of Bidrin and Imidan
when fed in silage to lactating dairy cows. Journal of Dairy
Science 51(8):1225-1228.
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V. FORMS APPENDICES
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FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
'RODUCT NAME
APPLICANT'S NAME
I DATE GUIDANCE DOCUMENT ISSUED
With respect to tne requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in tne referenced
Guidance Document, I am responding in the following manner.
_ 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from lor are no:
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to tne Cnemicals Group, OECC
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2HB)lii) to satisfy the following date
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification of Attempt to Enter Into in Agreement with Other Registrants for Development of Data" win.
respect to the following data requirements:
D 4. I request that you emend my registration by deleting the following uses (this option is not evailable to applicants tor new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not evailable to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1
-------
Appendix II-4
OME Approval 2070-0057 (expires 5/31/86)
(To qualify, certify &AJ. four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1.. I 3m 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:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY DUMBER
(This firm_c-" group of firms is referred to below as "my firm".)
Ej 2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm wouki prefer to -sntar
agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required j
. .-. , ..... „ ,, ,_ emu auuMiii LUC uaid aa iei|uueu uy mai iiuuu
into an agreement with one or more other registrants to develop jointly, or
items or data:
3. My firm lies offered in writing to inter into such in agreement Copies of the offers are attached. That offer was irrevocable and indeed nc? drier la be
bound by art arbitration decision under FIFRA Section 3(c)(2){B)(iii) if final agreement on all terms could not be rmhed ottteraiiss. This pffen oas made t
to the fDiluting firm(s) on the following dite(s): I
NAME OF FIRM
However, none of those firm(s) accepted my offer.
DATE OF OPFEK
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firmt named in paragraph (3) above
have agrsed 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(cH2)(B). (This statement \
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request. *
TVPED NAME
SIGNATURE
DATE
-------
EpA Reg. No.
Guidance Document for
PRODUCT SPECIFIC DATA REPORT
Date
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 point
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
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
53-19
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
Flartmability
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
-------
FORMULATOR'S EXEMPTION STATQ»JT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name-and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify thats
(1) This product contains the active ingredient(s): -__ -
(2) Each active ingredient listed in paragraph CD is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration nunber and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Fonr. No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (I) is/are listed below:
Active ingredient Source; Product name and Reg. No.
Signature
oate Title
EPA Form (April 1985)
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