Unrttd Statw
Environmental Protection
AoMicy
Officaof
pMicidasandToxieSubrtMKM September 1988
540/RS-88-121
WMhington OC 20460
vvEPA
PaiticidM
Guidance for the
Reregistration of
Pesticide Products
Containing TERBUFOS
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
REVISED GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
TERBUFOS
AS THE ACTIVE INGREDIENT
CASE NUMBER 0109
CAS Registry Number 13071-79-9
EPA Pesticide Chemical Code (Shaughnessy)
Number 105001
SEPTEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Preliminary Risk Assessment
C. Environmental Profile
D. Pesticide Incident Reports
E. Tolerance Reassessment
IV. Regulatory Position and Rationale 20
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 30
VI. Requirement for Submittal of Generic Data 32
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant Requests Regarding Data
Requirements and Agency Responses
F. Test Protocols and Standards
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submittal of Product-Specific Data . . 38
VIII. Requirement for Submittal of Revised Labeling ...... 39
IX. Instructions for Submittal 39
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
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APPENDICES
I. DATA APPENDICES 43
Guide to Tables 44
Table A 47
Table B 69
II. LABELING APPENDICES 74
Summary of Label Requirements and Table 75
40 CFR 162.10 Labeling Requirements 85
Physical/Chemical Hazards Labeling Statements ... 90
Storage Instructions 91
Container Disposal Instructions 92
.Pesticide Disposal Instructions 93
III. BIBLIOGRAPHY APPENDICES 94
Guide to Bibliography 95
Bibliography 97
IV. FORMS APPENDICES Ill
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet .... 112
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data 113
EPA Form 8580-4 Product Specific Data Report 114
EPA Form 8570-27 Generic Data Exemption Statement . . . 116
EPA Form Certification With Respect to Citation
of Data 117
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GLOSSARY OF TERMS AND ABBREVATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
ai Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
DCI Data Call-in Notice
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment, such
as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide,, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
Ib ai/A Pounds of active ingredient per acre
LEL Lowest-Effect Level
MATC Maximum Acceptable Toxicant Concentration
MPI Maximum Permissible Intake
MRID Master Record Identification (Number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing-Use Product
NPDES National Pollution Discharge Elimination System
NOEL No-Observed-Effect Level
OPP Office of Pesticide Programs
OES Office of Endangered Species, U.S. Fish and Wildlife
Service
111
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PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
RED Reference Dose
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
This document is a revised Registration Standard for
the subject chemical, In its original Standard, issued in
June 1983, the Agency described the available data supporting
the registration of the chemical. The Agency concluded that
additional data were necessary to fully evaluate the pesticide.
The Agency also set out label language which the Agency concluded
at that time were needed to ensure that products containing the
Lciilrt remained in compliance with FIFRA.
The Agency has since received and reviewed the additional
data and has revised its scientific and regulatory conclusions
in light of those data, other information on the chemical,.
and expanded data requirements promulgated in 1984, at 40 CFR
Part 158, for registration and reregistration of pesticides
under FIFRA.
The revised Registration Standard, which supersedes the
earlier Standard, is the Agency's updated scientific assessment
of the pesticide, and the data needed to support its continued
(registration. The Agency has also reassessed the tolerances
for the pesticide; that reassessment is included in this
Registration Standard.
The Agency has also reviewed the current labeling for
products containing the pesticide, and has specified label
revisions which are necessary to remain in compliance with
FIFRA.
The detailed scientific review, which is not contained in
i;hi. s document but is available upon request 1, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient. However, during the review of these data the
Agency is also looking for potential hazards that may be associated
with the EPs that contain the ai. The Agency will apply the
provisions of this Registration Standard to EPs 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
IV - Regulatory Positions and Rationales. Based on its regulatory
position, the Agency may prescribe a variety of steps to be
scientific reviews and the EPA Compendium of Acceptable Uses
may be obtained from the National Technical Information Service,
5285 Port Royal Rd., Springfield, VA. 22161. Phone: (703) 487-4650,
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taken by registrants to maintain their registrations in compliance
with FIFRA. These steps may include:
1. Submission of data in support of product registration ;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
oC uses o£ the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the DCI provisions of FIFRA
section 3(c)(2)(B) to requice that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide. These data are
listed in the Tables A, B, and C in Appendix I. Failure to
comply with the DCI requirements enumerated in this Registration
Standard may result in issuance by EPA of a Notice of Intent to
Susp'end 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. Registrants must notify the Agency
of any information, including interim or preliminary results of
studies, if that information suggests possible adverse effects
on man or the environment. This requirement is independent of
the specific time requirements imposed by EPA for submission of
completed studies called in by the Agency and continues as long
as a product is registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common Name : Terbufos
Chemical Name: S-[[(1,1-dimethylethyl)thio]methyl]0,0-
diethyl phosphorodithioate
Other Chemical Nomenclature: S-[(tert-butylthio)methyl]
0,0-diethyl phosphorodithioate (IUPAC);
S-(t_-butylthio) methyl 0,0-diethyl-
phosphorodithioate (CA, 8th Collective
Index) ; S^-tert-butylmercaptomethyl
0,0-diethyl dithiophosphate
Trade Names: Contraven; Counter; AC 92,100; CL 92,100;
and ST-100
CAS Registry Number: 13071-79-9
EPA Pesticide Chemistry Code (Shaughnessy) Number; 105001
Empirical Formula:
Molecular Weight: 288.4
Chemical/Physical
Characteristics oE a 35% Technical Grade (T) and the
Purified Active Ingredient (PAI):
Color: clear, brownish (T)
Physical State: liquid (T)
Odor: mercaptan-like (T)
Specific gravity: 1.105 g/cm3 at 24 °C
Boiling point: 55 °C at 0,02 mm Hg (T)
Melting point: N/A; technical grade in a
liquid at room temperature (T)
Solubility: > 110 g/100 mL in acetone, benzene,
chloroform, 1,2-dichloroethene, or
ethaool at room temperature (T)
pH: Data gap
Vapor pressure (PAI): 1.15 to 6.06 x 10~4 mm Hg
at 25 °C,
4.99 to 9.78 x 10"4 mm Hg
at 35 °C,
9.41 to 16.2 x 10~4 mm Hg
at 45 °C.
Stability: It is relatively stable in water
under neutral or slightly acidic
conditions but is subject to
hydrolysis under alkaline condi-
tions. It decomposed on prolonged
heating at temperatures greater
than 120 °C (T).
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B. Use Profile
Terbufos, an organophosphate insecticide/nematocide,
is principally used as an insecticide for corn rootworms on corn.
Other uses include use as a nematocide for lesion, spiral, stunt,
sting, stubby-root, and dagger nematodes on corn; and as an
insecticide for greenbugs on grain sorghum, sugar beet root maggot
on sugar beets, and seedcorn maggots, symphylans, wireworms. mai^e
billbug, southern corn billbug, and reduction of white grubs on
corn.
Although terbufos is normally applied as a soil-
incorporated treatment using ground equipment, it may be applied
as a broadcast treatment on corn using either air or ground
equipment. This use is limited to Nebraska, New Mexico, and Iowa.
There are no indoor nor domestic uses registered for
the chemical.
There are 'two Federal registrations for products
containing terbufos: one, an MP containing 85.0 percent terbufos,
the other, ^ granular EP containing 15.0 percent ai. There are
several Special Local Need Registrations which were issued for 15
percent granular products. There are no intrastate registrations,.
and no multiple active ingredient formulations registered,
American Cyanamid Company, Agricultural Division, is
currently the sole manufacturer of the technical product and
formulates oE granular EPS in the United States.
C. Regulatory History
Terbufos was first registered for use in the United
States in 1974.
In June 1983, the Agency issued the Terbufos Registration
Standard setting forth the Agency's regulatory positions based
on available data and imposing additional data requirements to
support the continued registration of the chemical.
The Terbufos Registration Standard was amended on
February 27, 1985 to require restricted use classification
labeling for the currently registered 15 percent granular product.
This restricted use classification was based on the high acute
oral and dermal toxicity to humans.
The registrant has submitted data in response to the
Terbufos Registration Standard issued June 1983. These data
have been evaluated by the Agency. This revised Registration
Standard sets forth the results of the Agency's reassessments of
the potential hazards arising from the currently registered uses
based on these data.
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III. AGENCY FINDINGS
A. Summary
The following is a summary of findings based on the
available data. Please refer to the context of EPA's science
findings, Sections B through E of this chapter, for further
details.
1. Technical terbufos is highly acutely toxic by the
oral, dermal, and inhalation routes of exposure, placing it in
Toxicity Category I for all three routes.
Because mortality to the test animals would occur
prior to the onset of any primary eye or dermal irritation or
dermal sensitization, these effects were not evaluated for
technical terbufos, and no further data are being required.
The acute delayed neurotoxicity study in chickens
was negative for acute neurotoxic effects.
2. Terbufos is a cholinesterase inhibitor, reducing
plasma, brain, and red blood cell (RBC) cholinesterase (ChE)
activity. Based on the available dog feeding studies, the NOEL
for plasma ChE inhibition and brain/RBC ChE, are 0.00125 and
0.060 mg/kg/day, respectively.
3. Results of the available oncogenicity and mutagenicity
studies are negative. The Maximum Tolerated Dose (.MTD) was reached
in the oncogenicity studies.
4. Based on the review of a three-generation rat study
using concentrations of 0.25 and 1.0 ppm, the reproductive NOEL
for terbufos is considered to be 0.25 ppm. At the 1.0 ppm dose
level, there was an increased percentage of litters with offspring
deaths as compared with the controls. Because these effects
occurred at a dose level which is above the plasma ChE inhibition
NOEL established for regulatory purpose, an ample margin of safety
exists.
5. Based on the review of a rat teratology study,
the NOEL for.developmental effects has been tentatively set at
0.1 mg/kg/day. A teratology study in rabbits is needed to fulfill
the Guideline requirements. Based on the available rat study,
the chemical does not demonstrate a teratogenic potential.
6. Based on results of a rat metabolism study, terbufos
was rapidly excreted within 168 hours of administration. Neither
the parent compound nor its metabolites accumulated in tissues.
7. The use of terbufos poses a potential risk to
loaders and applicators; and to persons reentering treated fields
following nonsoil-incorporated broadcast application of the
chemical. The major route of exposure is dermal and the Agency
is imposing the use of additional protective clothing, a reentry
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restriction, and a prohibition against non-soil-incorporated
broadcast application on corn prior to any detasseling operations.
8. Laboratory data show that t^cbufos is highly toxic
to avian species and to fish and aquatic invertebrates. Results
of level 1 field studies demonstrate the potential for exposure
to nontarget organisms and that birds, mammals, reptiles, and
Cish may be killed by certain applications of terbufos. Level 2,
or population studies, are required for the Agency to complete
its assessment of the impacts of terbuEos to nontarget terrestrial
organisms. Aquatic organism field testing and residue monitoring
studies are required to complete its assessment of the impacts of
ter'oufos on aquatic organisms.
9. Due to the numerous gaps in residue chemistry
data, the Agency is unable to complete a tolerance reassessment
of terbufos. The toxicology data requirements to support the
tolerances have been met with the exception of a teratology study
in rabbits. The reference dose (RfD) for humans is established at
0.000125 mg/kg/ day and the TMRC is estimated to be 0,000052
mg/kg/day which is equivalent to 41.946 percent of the RfD.
10. The Agency is unable to assess the potential for
terbufos to contaminate ground water due.to the lack of pertinent
environmental (rate data.
B. Preliminary Health Risk Assessment
The following assessment is based on EPA's review of
the available data.
1. Acute Toxicity
Sufficient data are available to classify
technical teirbuEos as Toxicity Category I due to its oral and
dermal toxicity with an acute oral toxicity of 1.6 and 1.3 mg/kg
for male and female rats, respectively; and an acute dermal
toxicity of 0.81 and 0.93 mg/kg for male and female rabbits,
respectively. The available repeated (21-day) inhalation study
is sufficient to assess the acute inhalation toxicity of terbufos.
Based on the mortality observed in the female rats (2/10) and the
ChE activity depression observed in both sexes at inhalation
exposures which are approximately 2000-fold less than the require-
ments Cor Category I (£0.2 mg/L), technical terbufos is classified
as Toxicity Category I for acute inhalation toxicity. Technical
terbufos was highly toxic to rabbits in primary eye and dermal
irritation tests to the extent that all rabbits died within 72
and 24 hours, respectively. A dermal sensitization study is not
available and none is required since mortality would occur before
sensitization. In an acute delayed neurotoxicity study in hens,
there was no evidence of acute delayed neurotoxicity at the 40
mg/kg dosage level tested.
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2. Subchronic Toxicity
In a 90-day subchronic oral study, Sprague-Dawley
rats were given terbufos in the diet at 0, 0.125 (0.00625 mg/kg),
0.250 (0.0125 mg/kg), 0.50 (0.025 mg/kg) and 1.00 ppm(0.05 mg/kg).
The systemic NOEL in this study was determined to be 0.25 ppm
based on a significant increase in the liver weight associated
with an increase in the incidence of the liver extramedullary
hematopoiesis. The NOEL for ChE inhibition was determined to be
0.25 ppm. A subchronic 90-day oral study is not required in the
dog because the available chronic dog study in conjunction with
the 4-week ChE dog study are sufficient for establishing a ChE
NOEL for terbufos.
In a subchronic dermal study, rabbits were exposed
for 30 days to dosages of 0.004, 0.02, or 0.10 mg/kg of the technical
material. At the lowest effect level of 0.10 mg/kg, edema and
erythema were reported. The systemic NOEL was determined to be
0.020 mg/kg. The ChE activity was not determined.
Ninety-day dermal and inhalation studies are not
required because repeated dermal or inhalation exposure is not
expected to occur from the current registered pesticidal use of
terbufos. Since there was no evidence of a neurotoxic effect in
the available acute neurotoxicity study, the subchronic neurotoxicity
study is not required.
3. Chronic Toxicity and Oncogenicity
In a 2-year feeding/oncogenicity study, female
Long Evans strain rats were fed dosages of 0, 0.25 (0.0125 mg/kg),
1.0 (0.05 mg/kg) or 4.0 (0.2 mg/kg) ppm terbufos; male Long Evans
strain rats were fed dosages of 0, 0.25, 1.0, 4.0, or 8.0 (0.4
mg/kg) ppm. Both systemic and ChE inhibition effects were observed
at the lowest dosage tested (0.25 ppm) and were dose-related. A
NOEL could not be determined from this study. There were no
oncogenic effects observed in this study.
A 1-year rat study was conducted for purposes of
obtaining a NOEL and, though no systemic effects were noted at
any dose (the highest dose tested was 1.0 ppm), the NOEL for
plasma and brain ChE was 0.5 ppm, which was the mid-dose of the
study. The 2-year rat study, when considered in conjunction
with the 1-year rat study, satisfies the requirement for a chronic
toxicity study in a rodent species.
In an 18-month oncogenicity study, in which groups
of 65 male and 65 female Charles River CD-I mice were fed technical
terbufos at dietary levels of 0, 3.0 (0.45 mg/kg), 6.0 (0.90 mg/kg),
or 12.0 ppm(1.80 mg/kg), there was no evidence that technical
terbufos had an oncogenic effect at any of the dose levels of
this study. There was a possible slight increase in mortality as
well as a decrease in body weight gain in the high-dose group.
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In a 1-year oral study, male and female dogs were
administered terbufos in capsule form at dose levels of 0, 15,
60, 90, or 120 ug/kg/day. In this study, consistent, moderate
to large depressions in plasma ChE activity occurred in both male
and female dogs at all dose levels. Although a NOEL could not be
determined for plasma ChE, the systemic NOEL was determined to be
120 ug/kg/day (the highest dose tested) since no systemic effects
(other than ChE) were observed. This study, when taken into
consideration with the 4-week dog plasma ChE study (described
below), satisfies the requirement for a chronic toxicity study in
a nonrodent species. The NOEL for brain/RBC ChE in this study is
60 ug/kg/day.
4. ChE Inhibition
A special 4-week ChE study was conducted in dogs
to define the dose-response of terbufos for plasma ChE. In this
study, male and female dogs were administered terbufos in capsule
form at dose levels of 0, 1.25, 2.5, 5.0, or 15.0 ug/kg/day. A
plasma ChE NOEL is sfet at 1.25 ug/kg/day.
Dose-related plasma ChE inhibition was observed at
the two lower dosages of 5 and 1.25 ug/kg/day in both male and
female dogs. In males, ChE activity was approximately 80 percent
of control values during all sampling periods at 5 ug/kg/day with
10 to ,15 percent (depending on which control values are used)
inhibition at 2.5 ug/kg/day. No essential inhibition of plasma
ChE occurred at the lowest dose of 1.25 ug/kg/day. A similar
pattern of enzyme activity was observed in the females, with 20
to 30 percent inhibition at the 5 ug/kg/day dose level for weeks
1, 2, and 4, and 10 to 20 percent inhibition at the 2.5 ug/kg/day
dose levels (again depending upon whether concurrent or pretest
control values are compared). No inhibition was observed at the
lowest dose tested of 1.25 ug/kg/day.
Brain and RBC ChE activities were also evaluated
in this study. Terbufos did not depress RBC ChE activity in
either male or female dogs at any dose or sampling time period
during the study. This lack of depression upon RBC ChE is in
agreement with the lack of effects at dosages of 15 ug/kg observed
in the 1-year dog study described above. No compound-related
effect for brain ChE activity was observed in either males or
females at 15 ug/kg.
5. Metabolism
In male rats, terbufos was rapidly excreted as
the diethyl phosphoric acid and other polar metabolites (83%)
in urine within 168 hours of administration. Terbufos and its
metabolites were not noted to accumulate in tissues.
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6. Mutagenicity
The Agency has reviewed the available data and
results of these studies are summarized below. No additional
mutagenicity data are required.
Ames - With and without chromosomal activation,
the results were negative at concentrations
up to 1000 meg per plate.
Acute in vivo Cytogenetic Assay - Terbufos did not
appear to cause any chromosomal aberrations.
The maximum doses tested were 1.8 mg/kg in
males and 1.5 mg/kg in females (higher doses
caused mortality).
Dominant Lethal - In rats, the only apparent possible
compound-related effects on fertility were
in the high-dose group (0.4 mg/kg) where
^the number of viable implants was slightly,
'but significantly, reduced at mating 9, and
implantation efficiency was significantly
lower at mating 7 as well as suggestively
(not significant) lower during matings 8,
9, and 10.
7. Reproduction
The Agency evaluated a three-generation rat
reproduction study utilizing dosages of 0.25 and 1.0 ppm. At
the 1.0 ppm dose level, there was .an increase in the percentage
of litters with offspring death in each of three generations as
compared with the controls. A NOEL of 0.25 ppm for reproduction
effects was established for the study. No additional reproduction
data are needed.
8. Developmental Toxicity
The Agency evaluated two ca'obit teratology studies
and one rat teratology study. The rat study in which pregnant
COBS® CD female rats were orally administered technical terbufos
during days 6 through 15 of gestation at dose levels of 0, 0.05,
0.10, or 0.20 mg/kg/day is acceptable for assessing the potential
developmental toxicity of terbufos. In this study, the maternal
toxicity NOEL was established at > 0.2 mg/kg (HDT). There was
an increase (not statistically different) in the number of early
resorptions and the number of litters with two or more resorptions
at 0.1 and 0.2 mg/kg, and increased postimplantation loss at
0.2 mg/kg. The developmental toxicity NOEL was conservatively
established at 0.1 mg/kg and the LEL at 0.2 mg/kg. Of the two
available rabbit studies, one was considered invalid due to the
uncertainty as to the actual dose levels or test material admini-
stered to the rabbits during the test period. The other study
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was considered unacceptable due to inadequate numbers of litters,
excessive maternal wastage, low insemination rate and/or implanta-
tion efficiency, high variation in reported doses administered,
and questions due to apparent gavage errors. A new rabbit
teratology study is required.
9. Occupational Exposure Risk
Limited field worker exposure data were gathered
in a study utilizing aerial application of 1.0 Ib ai terbufos
per acre to corn in Nebraska. Since the dermal exposure data
collected during this study are not acceptable, primarily due
to the methodology used for assessing hand exposure, the foliar
dislodgeable residue levels (FDRs) on corn were used to calculate
the predicted levels of dermal exposure. The FDRs were used in
combination with surrogate data to give estimated dermal exposure
levels of 118 ug/hour on 3 days after application and 73 ug/hour
on 7 days after application. Utilizing an oral 4-week ChE inhibition
study in dogs with a ChE NOEL of 0.00125 mg/kg, and a safety factor
of 10, the calculated allowable exposure level for humans is
estimated to be 1.22 mg/hr for a 60 kg. person. Since exposure
to fieldworkers would be primarily by the dermal route, a dermal
toxicity study in test animals would be more appropriate for the
calculation of allowable human exposure levels and a special
21-day dermal study in rats to establish a NOEL for ChE inhibition
is being requested for this purpose.
Environmental conditions, especially rainfall,
humidity, and dew have a strong influence on the rate of dissipation
of organophosphorous pesticides such as terbufos. It is expected
that a broadcast application without soil incorporation of terbufos
in an arid environment such as the Southwestern States would
result in greater exposure to fieldworkers in those States. A
dislodgeable residue study to be conducted in New Mexico is
therefore needed to estimate fieldworker exposure in the arid
Southwest resulting from aerial or broadcast application to corn.
At present, New Mexico is the only Southwestern State in which
such a use of terbufos is registered.
The required protective clothing for workers
reentering corn fields within 7 days of broadcast application
without soil incorporation and the prohibition of nonsoil-
incorporated terbufos application prior to detasseling activities
imposed in this Registration Standard would mitigate adverse
effects to workers reentering the treated areas pending submittal
and evaluation of the special dermal study and the dislodgeable
residue study described above.
There is little potential for worker reentry
exposure in fields treated with a ground-incorporated application
of terbufos. Consequently, no reentry data or reentry interval
are required to support these uses.
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C. Environmental Profile
1. Ecological Effects
a. Terrestrial Species
Based on acceptable laboratory data, technical
terbuEos is highly toxic to upland game birds on an acute oral
basis with a single-dose oral toxicity value of 28.6 mg/kg.
Based on two acceptable subacute dietary studies in birds,
technical terbufos is highly toxic to upland game birds with
subacute toxicity values of 143 and 157 ppm.
Two acceptable avian reproduction studies were
reviewed - one conducted with the bobwhite quail, the other with
the mallard duck. The quail study showed no reproductive effects
at concentrations up to 30 ppm in the diet. In the mallard duck
study, there were no apparent effects at 1 and 5 ppm but there
was a slight reduction in embryo viability at 15 ppm. This effect
was not considered to be statistically significant.
Te'rrestrial organisms may be exposed to terbufos
directly through ingestion of granules at or near the soil surface.
Based on a granular weight of 0.1 mg, it is calculated that it
would take 27 granules of a 15 percent terbufos product to reach
the acute oral toxicity of a small bird such as a Eield sparrow
with a weight of 0.0139 kg, if such a bird had the same sensitivity
to terbufos as the bobwhite quail. However, in the available
toxicity screening studies it was found that 10 granules killed
all five redwinged blackbirds given this dose and killed two of
the five house sparrows receiving this dose. A dose of 20 granules
killed four of the five blackbirds receiving this dose. None of
the blackbirds receiving dosages of 1 and 5 granules were killed.
These results suggest that an approximate median lethal dose (the
dose that can be expected to cause death in 50% of the test animals)
for the redwinged blackbird is likely to be greater than 5 (0.075
mg terbufos), but less than 10 granules (0.15 mg terbufos) of the
15 percent terbufos product. With 0.07 kg as the bodyweight oE
the blackbird, the calculated median lethal dose would be between
1.1 and 2.1 mg ai/kg bodyweight. This would be 13 times the
median lethal dose of 28.6 mg/kg found in the previously mentioned
bobwhite quail acute oral toxicity study in which technical
terbufos was used as the test substance. Since only granules
were tested in the screening studies, it was not clear whether
this increased toxicity was due to differences in sensitivity
between the two test species or increased toxicity of the 15
percent granular formulation, or both. While results of acute
oral toxicity testing using both the technical terbufos and the
15 percent granular product indicate thai; the 15 percent formulation
is less toxic than the technical, they do not address the species
sensitivity question.
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Based on an acceptable level 1 terrestrial
field study, a 15 percent granular formulation of terbufos caused
acute mortality of terrestrial nontarget species when applied to
corn fields. In this study, 2 Ib ai/A applied at time of planting
as a soil-incorporated treatment resulted in mortalities to birds
and reptiles, while aerially broadcast unincorporated granules
applied to a maturing corn crop at one-half this rate resulted
in significant mammal, bird, and reptile acute mortality. No
secondary poisonings were observed.
Other studies reviewed by the Agency include an
additional terrestrial field study in which a 15 percent granular
terbufos product was applied to corn fields at 1 Ib ai/A and an
outdoor pen study in which ring-necked pheasants were exposed to
soil treated with the 15 percent granular product at rates equiva-
lent to 1 and 5 Ib technical terbufos/A. While results of the
field study implied minimal effects on wildlife, it was not
acceptable for use in a hazard assessment of terbufos. Deficiencies
in the study include use of maximum application rates which were
lower than the currently registered maximum rate; a limited
number of searches for dead animals, and no analysis for ChE
inhibition. While the results of the pen study also indicated
minimal hazard to the species tested, it was deficient in that
the exposure was not considered representative of the principal
route of exposure under conditions of actual use which is expected
to be dietary. Since clean food and water were provided at all
times during the study, exposure to terbufos was principally
dermal.
Based on the adverse effects observed in the
acceptable level 1 study described above, the Agency is requiring
population studies or level 2 terrestrial field studies to assess
the potential effects on populations of birds, mammals, and
reptiles and to complete its evaluation of the potential hazard
to terrestrial nontarget species.
b. Aquatic Species
Based on acceptable laboratory studies,
technical terbufos is very highly toxic to freshwater fish and to
freshwater invertebrates on an acute basis. The acute toxicity
values for freshwater fish range from 0.77 to 20.00 parts per
billion (ppb). The acute toxicity for freshwater invertebrates
(Daphnia maqna) is 0.31 ppb. Technical terbufos appears to be
highly toxic to marine/estuarine fish based on results of a
96-hour acute toxicity study on sheepshead minnow, and to marine/
estuarine invertebrates based on results of a 96-hour acute
toxicity study on mysid shrimp. These studies deviated from the
recommended protocols, however, and are not adequate to completely
characterize the acute toxicity of technical terbufos to either
of these species. There was no information available to characterize
the toxicity of technical terbufos to marine/estuarine molluscs.
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The acute toxicity studies with estuarine and marine organisms
are required because some of the crops (e.g., field corn and
sorghum) may involve use of the chemical on more than 300,000
acres in coastal counties and because use on these crops is
likely to result in runoff that may be transported to the habitats
of estuarine and marine organisms.
Based on results of an aquatic invertebrate life
cycle study using Daphnia magna, technical terbufos is extremely
chronically toxic to freshwater aquatic invertebrates with an
maximum acceptable toxicant concentration (MATC) in the parts per
trillion (ppt) range based on growth, survival, and reproduction.
The available information is not sufficient to completely charac-
terize the chronic toxicity of terbufos to fish in an early life
stage test. The available test, which was conducted with rainbow
trout, is not acceptable because it failed to meet the requirement
that at least one test level must adversely affect a life stage.
This study is required because the lowest fish acute toxicity
value (0.77 ppb) is well under 1 mg ai/L; results of the initial
modeling show the EEC in water is greater than 0.01 of the acute
toxicity; the hydrolylic half-life is greater than 4 days at 5,
7, and 9; some degradates, based on their structure, may have a
toxicity similar: to oc greater than that of the parent compound;
and due to terbufos1 broad and repeated use in corn, the chemical
is expected to be transported to water from the intended use
site.
A Daphnia magna acute toxicity study and two
96-hour fish studies using the 15 percent granular formulation
were reviewed and found acceptable. Based on the results of
these studies, the formulated product is very highly toxic to
bluegill sunfish, rainbow trout, and Daphnia magna with acute
toxicity values of 12.3, 59.7, and 6.2 ppb, respectively.
Aquatic organisms may be exposed to terbufos
through runoff of the granules or through transport of soil or
water containing residues of terbufos or its degradates. This
potential exposure has been demonstrated by reports of a fish
kill incident. During the conduct of the previously described
acceptable level 1 terrestrial field study, an aerial broadcast
application to a corn field in the Chesapeake Bay region reportedly
resulted in an estuarine fish kill. Based on the results of initial
modeling conducted by the Agency for the 1983 Terbufos Registration
Standard, aquatic EECs resulting from the soil-incorporated use
of terbufos may pose an acute hazard for freshwater and marine/
estuarine species. Potentially greater hazards are likely for
aerial applications of terbufos granules since soil-incorporated
applications typically provide less exposure than aerial broadcast
applications. The Agency used a computer model to simulate runoff
from granular applications of terbufos. The EECs of terbufos in
the hypothetical ponds of the model ranged from 7.4 ppb on day
15, immediately after the second runoff event, and declined to
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0.035 ppb by day 60. Residues sorbed to benthic sediment were
3.7 ppb on day 26 and declined to 2.1 ppb by day 60. The model
was not able to consider degradates, certain of which (based on
molecular structure) may be as toxic as terbufos itself. On the
basis of terbufos toxicity to aquatic organisms, the EEC levels
may pose an acute hazard for freshwater and marine/estaurine
species. Residue levels of concern were exceeded for 38 to
56 days out of a total of 56 days following initial pesticide
runoff. The potential chronic hazard to freshwater invertebrates
may be even greater than the acute hazard based on results of the
previously described 21-day chronic (life-cycle) study which
showed Daphnia magna to be extremely sensitive to terbufos.
Although these theoretical calculations and
modeling indicate that the use of terbufos may result in adverse
effects to aquatic species, actual field monitoring data are not
available to support this finding. Moreover, the environmental
fate characteristics of tecbufos are not accurately defined by
available data. Thus the models can be used only on a limited
basis.
Acjuatic residue monitoring studies will be
required to determine actual residues in aquatic systems exposed
to runoff and spray drift. Although these studies were previously
requested in the 1983 Terbufos Registration Standard, their initi-
ation was delayed pending the Agency's recalculation of the EECs.
Prior to the completion of this task, reports of the above described
fish kill incident demonstrating the potential exposure to aquatic
organisms under actual field use conditions became available. In
addition, several environmental fate studies previously found
acceptable do not meet current Guideline requirements and need to
be repeated.
.Based on new acute and chronic data as well as
the reported fish kills, aquatic field studies are required to
investigate the potential adverse effects to aquatic organism
populations of aquatic exposures to terbufos resulting from
drift and runoff of agricultural applications of the chemical.
These studies should be conducted on both freshwater and marine/
estuarine sites with corn as the crop.
c. Nontarget Insects
Since terbufos is registered only as a granular
formulation, no significant bee exposure is expected.
d. Endangered Species
There is sufficient information to indicate
that current registered uses of terbufos may adversely affect
endangered species. Threshold levels of concern to aquatic
endangered species (EEC > 1/20 acute toxicity value) are exceeded
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by terrestrial, soil-incorporated applications (due to runoff).
Potentially greater hazards are likely for aerial applications
of terbufos granules since soil-incorporated applications typically
provide less exposure than aerial broadcast applications.
Terbufos has been identified by the Office of
Endangered Species (OES), U.S. Fish and Wildlife Service (USFWS),
as being likely to jeopardize the continued existence of certain
endangered species when used on corn and sorghum. Based on this
determination, OES specified reasonable and prudent alternatives
to avoid jeopardizing the continued existence of the identified
species. EPA is working with USFWS and other Federal and State
agencies to implement the alternatives in a technically sound
manner.
Formal consultation will be initiated with
OES under Section 7 of the Endangered Species Act regarding the
potential exposure to endangered species resulting from the
registered use of terbufos on sugar beets.
2. Environmental Fate
Results of an acceptable hydrolysis study indicate
that terbufos degrades with a half-life of 2.2 weeks. Formaldehyde
was the major degradate detected in this study. Results of an
acceptable aerobic soil metabolism study indicate that terbufos
degrades in silt loam soil with a half-life of 26.7 days. The
major degradates detected in this study included carbon dioxide,
terbufos sulfoxide, and terbufos sulfone.
Results of a field dissipation study, classified
as supplementary, indicate that terbufos residues have a half-
life of less than 40 days in field plots of loam soil located
near Arcola, Illinois, and sandy loam soil located near Greeley,
Colorado treated with a 15 percent granular formulation at
an application rate of 1 Ib ai/A. The sampling protocol was
inadequate to accurately assess the dissipation.of terbufos
residues in field soil and a new study is required.
The available data reviewed by the Agency are not
sufficient to fulfill data requirements nor to assess the environ-
mental fate of terbufos. Four studies previously reviewed and
found acceptable under the 1983 Terbufos Registration Standard do
not meet the requirements of the Agency's current guidelines and
new studies are required. These are: anaerobic soil metabolism,
leaching, fish accumulation, and field dissipation. In addition,
several new studies are now required due to the additional method
broadcast (air or ground equipment) application without soil
incorporation which was not registered at the time of the 1983
Terbufos Registration Standard.
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Based on an inadequate data base, no definitive
conclusions can be made about the potential for terbufos to leach
to ground water. Terbufos residues were reported to occur in
well-water sampling in Iowa and Minnesota. These reports, however
have not been confirmed in the laboratory and a resampling of the
same Iowa wells a year later, in 1986, showed no detections for
terbufos or its degradates. The earlier report of the Minnesota
well detection has been attributed to a point source and not to
normal agricultural application. Because terbufos is so suscep-
tible to hydrolysis, there is some question about any laboratory's
ability to detect it or confirm a detection. Terbufos has been
identified as an unstable analyte in the National Well Water
Survey. Additional data are required to assess the mobility and
leaching characteristics of terbufos and its degradates. These
data include leaching and soil dissipation studies.
No ground water monitoring studies are required
at this time. Pending receipt and evaluation of more complete
environmental fate information, ground water monitoring studies
may be required in the future.
D. Pesticide Incident Reports
Data on occupational illness due to pesticide exposure
have been received from California, which requires that all such
physician-treated illnesses be reported to the State. There were
no physician-treated cases of terbufos poisoning from 1980 through
1986. During this same period, there were no reported hospitalized
cases of occupational terbufos poisoning. Based on a 12 percent
sample of the nation's hospitals, there were no observed cases
of hospitalization due to terbufos exposure during the time period
from 1971 through 1976. The Terbufos Registration Standard
issued in 1983 included information obtained from the Pesticide
Incident Monitoring System (PIMS), which was utilized by the
Agency prior to 1982, and which showed 31 reports involving
terbufos. The Agency concluded, as was stated in the 1983 Terbufos
Registration Standard, that carelessness and/or negligence appear
to have been important factors in most instances, and that strict
adherence to proper storage and application techniques as prescribed
in the label directions and precautions will minimize the risk of
potential adverse effects to humans and domestic animals.
E. Tolerance Reassessment
1. Tolerances Issued
Tolerances have been established for combined
residues of terbufos and its ChE-inhibiting metabolites in or
on the raw agricultural commodities bananas, sugar beets, corn,
and sorghum (40 CFR 180.352). No food additive tolerances have
been established for terbufos. Canadian tolerances exist on a
negligible residue basis (at less than 0.1 ppm in human food)
for sugar beets and corn. There are no Mexican tolerances and
no Codex maximum residue limits (MRLs) set for terbufos. There-
fore, no compatibility questions exist with respect to the Codex
MRL.
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The tolerance on bananas expires on Apcil 27, 1990
because of the lack of a teratology study in a second species.
Should the Agency find that the new rabbit teratology study is
acceptable, it will reassess the tolerance for bananas and, if
appropriate, will establish a permanent tolerance for this commodity,
The established tolerances for terbufos are
presently expressed in terms of terbufos and its ChE-inhibiting
metabolites without specifying the latter as phosphorylated
metabolites. The Agency will propose revising 40 CFR 180.352 by
changing the wording to read:
"...terbufos... and its phosphorylated (cholinesterase-inhibiting)
metabolites:
o Phosphorothioic acid, j5-(_t-butyl-thio) methyl
0,0-diethyl ester.
o Phosphorothioic acid, S-(t-butyl-sulfinyl)
methyl 0,0-diethyl ester.
o Phosphorothioic acid, ^-{_t-butyl-sulfonyl)
methyl 0,0-diethyl ester.
o Phosphorodithioic acid,. 3-(^_-butyl-sulf inyl)
methyl 0,0-diethyl ester.
o Phosphorodithioic acid, J3-(t_-butyl-sulfonyl)
methyl 0,0-diethyl ester."
The Agency will also propose that the "(N)"
designation be deleted from the sugar beet roots, corn grain,
and sweet corn entries under 40 CFR 180.352. This designation
indicates that the preceding tolerance level was set at the
level of detection or on a negligible residue basis. Tolerances
are no longer established on a negligible basis, and such
designations are being systematically removed from 40 CFR 180.
Because of the residue chemistry data gaps, the
Agency cannot conduct a tolerance reassessment until the required
data are submitted and reviewed.
2. Residue Data
In the Terbufos Registration Standard dated June
1983, no outstanding data gaps were identified for residue chemistry.
However, subsequent amendments to registered uses for terbufos
and addenda to the Pesticide Assessment Guidelines (Subdivision
O) for Residue Chemistry have made it necessary to reevaluate
portions of the data base previously reviewed under the June 1983
Standard. As a result, some of the original conclusions regarding
adequacy of the data and support for tolerances have been modified
in this revised Registration Standard.
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a. Metabolism
Based on an evaluation of the available plant
metabolism studies, the Agency concludes that the nature of
residues in plants is adequately understood, The major portion
(70 to 90%) of the organosoluble l^C-residues present in the
treated plant tissues was characterized. Of the phosphorylated
metabolites, terbufoxon sulfoxide and terbufos sulfoxide comprised
<. 30 percent of the residues; and terbufos sulfone and terbufoxon
sulfone comprised £ 7 percent of the residues. The major nonphos-
phorylated metabolite which comprised <_ 30 percent of the organo-
soluble 14C-residues was nonphosphorylated terbufoxon sulfone and
the minor ones which comprised £ 13 percent were nonphosphorylated
terbofoxon sulfoxide, methane (t-butysulfonyl)(t-butylsulfonyl)
and methane (t-butylsulfinyl) (methylsulfinyl).
The available poultry and ruminant feeding
studies do not meet the current Guideline requirements for data
depicting the metabolism of terbufos in livestock. The studies
were not conducted with radiolabeled material not: were the animals
dosed at a level high enough for detection of residues in the
animal tissues and milk. The available rat metabolism study
conducted with radiolabeled terbufos indicates that residues were
rapidly excreted. Fifty percent of the total amount excreted
during the study was excreted at the end of 15 hours. Less than
0.1 ppm remained in each tissue at the termination of the study.
The major metabolites consisted of S-methylated series of metabolites
Should the requested ruminant and poultry metabolism studies
reveal that the metabolism of terbufos in these animals differs
from that in rats, then a swine metabolism study would be required.
b. Analytical Methodology
An adequate analytical method, published as
method I in PAM, Vol. II, is available for the collection of data
pertaining to the combined residues of terbufos and its ChE-
inhibiting metabolites in or on sugar beet tops and roots; corn
forage and grain; and sorghum. Because the nature of the residues
in animals is not adequately understood, no conclusions can be
made regarding the adequacy of the available methods for detection
of terbufos residues of concern in animal products. Upon receipt
of the required animal metabolism studies, the adequacy of the
available methods for detection of terbufos residues of concern
in animal products will be evaluated. Adequate methodology and
validation data for each of the metabolites identified in the
plant metabolism studies are available for only a few commodities.
Validation data pertaining to recovery of the individual metabolites
listed in the revised tolerance expression proposed by the Agency,
are required for additional representative plant commodities.
Terbufos residues are detected by the Food and Drug Administration
(FDA)-U.S. Department of Agriculture (USDA) multiresidue Protocols
II and III. Additional testing is needed by multiresidue Protocol
IV. In addition, each of the phosphorylated metabolites must be
tested by all four FDA-USDA multiresidue protocols.
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c. Residue Storage Stability
Available storage stability data indicate that
residues of terbuEos and its metabolites are stable in corn grain
and corn forage stored frozen for up to 5 months. No data are
available depicting the stability of these residues in or on
other plant commodities and these data ace required. In addition,
data are required depicting the storage stability of each separate
metabolite listed in the revised tolerance expression proposed by
the Agency. The need for storage stability data pertaining to
terbufos residues of concern in animal tissues will be addressed
upon receipt and evaluation of the required animal metabolism
st ud i e s.
d. Field Residue Data
The available data on the magnitude and levels
of residue of terbufos in the individual raw agricultural commodities
are not adequate to determine the adequacy of the established
tolerances on sugar Beets, corn, and sorghum and additional data
are required.
e. Processing Data
Data are available to demonstrate that terbufos
residues will not concentrate in sugar beet processed commodities.
Processing studies are lacking for corn and sorghum and are
required.
f. Meat, Milk, Poultry, and Eggs
The available poultry and ruminant feeding
studies, described in the metabolism section, show that no detectable
residues occur in eggs, chicken tissues, milk, or cattle tissues
from animals fed exaggerated dietary levels of terbufos and its
ChE-inhibiting metabolites. However, additional animal metabolism
data are required and a determination regarding the need for and
nature of tolerances for residues in meat, milk, poultry, and
eggs will be made upon receipt and evaluation of these data.
g. FDA Monitoring and Surveillance
The FDA Revised Total Diet studies, as well
as the Surveillance and Compliance program for domestic and
imported commodities, employ methodology which is known to determine
terbufos. No findings of terbufos were reported in Total Diet
study samples collected from April 1982 to April 1986. A total
of 234 Total Diet food items were analyzed. Information obtained
from FDA's Surveillance and Compliance program for samples
collected from the 1978 fiscal year to the 1987 fiscal year
indicate that a limited number of samples of various commodities
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were found to contain residues of terbufos. Tolerance-exceeding
residues of terbufos were observed in field corn silage (1.16 ppm,
1.10 ppm). Residues of terbufos were observed in the following
domestic commodities for which no tolerances exist: meat (0.007
ppm, 0.14 ppm) and meal feed product (200 ppm); animal fat (from
a trace to 0.44 ppm) and bone meal (from a trace to 0.08 ppm);
chicken fat (0.27 ppm) and meat and bone meal (trace); and spent
malt barley (trace). One imported commodity, chaom, was found to
contain 0.04 ppm. A total of 100,824 samples were analyzed.
3. Reference Dose (RfD)
Due to the lack of pertinent data, an RfD for
terbufos residues could not be established when the Terbufos
Registration Standard was issued in 1983.
Data lacking for the chronic feeding, oncogenicity,
and teratology data requirements have been received and evaluated.
With the exception of the rabbit teratology study, which was found
to be supplemental as described under Section III A.I. of this
document, they are a.cceptable for use in determining an RfD.
Based on the plasma ChE inhibition NOEL as defined
in a 4-week dog study (0.00125 mg/kg/day) and using a safety
factor of 10, the RfD for humans is 0.000125 mg/kg/day.
The current established tolerances for residues
of terbufos and its ChE-inhibiting metabolites result in a TMRC
of 0.000052 mg/kg/day and utilize 41.946 percent of the RfD.
This value utilizes the residue values of the published tolerances
and assumes that 100 percent of the crops were treated with
terbufos.
IV. REGULATORY POSITIONS AND RATIONALES
A. Regulatory Positions
1. The Agency is not placing terbufos into Special
Review at this time. Additional data are needed to complete the
Agency's risk assessment to aquatic and avian species, including
endangered species. The Agency is conducting a comparative avian
risk assessment of various granular pesticides including terbufos.
When this assessment is completed, further regulatory action may
be taken.
Rationale; Based on a high acute toxicity of terbufos to
avian species and the current registered uses of terbufos, there
exists a ffigh potential for adverse effects to avian species from
exposure to terbufos granules at or near the soil surface. This
potential for exposure to terbufos is demonstrated from results
of level 1 studies and is confirmed by bird kill incidents. The
Agency is currently evaluating these data in the context of a
comparative risk assessment of granular pesticides which may pose
a risk to birds. When this assessment is completed, the Agency
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will determine whether further regulatory action is necessary.
Theoretical calculations indicate that the predicted
concentrations of terbufos in the aquatic environment resulting
from the registered uses of terbufos might expose aquatic species
to residue levels exceeding risk criteria for Special Review.
These calculations, however, are based upon models and may not
be indicative of actual residue levels in aquatic sites. Upon
receipt and evaluation of the full-scale aquatic organism field
study and the aquatic residue monitoring data, a determination
will be made regarding further regulatory action.
2. A level II terrestrial field study, monitoring
studies in soil, water, sediment, and fish, and an aquatic organism
field study are required to support the continued registration of
terbufos.
Rationale; These studies are needed for the completion
of the Agency's assessment of the potential risk to both avian
and aquatic species resulting from registered uses of terbufos.
Refer to Section C.3.. in Chapter III of this document for a
discussion of the potential risks based on available data.
3. The Office of Endangered Species (OES) in the U.S.
Fish and Wildlife Service (USFWS) has determined that certain uses
of terbufos, including uses on corn and sorghum, may jeopardize
the continued existence of endangered species. EPA is developing
a program to reduce or eliminate exposure to these species to a
point where use does not result in jeopardy, and will issue
notice of any necessary labeling revisions when the program is
developed. No additional labeling is required at this time.
Labeling requirements issued in PR Notices 87-4 and 87-5 have
been withdrawn pending reissuance.
In addition, the Agency is seeking OES evaluation of
the additional use of terbufos on sugar beets.
Rationale: Technical terbufos is potentially highly
toxic to birds, fish, aquatic invertebrates, mammals, and reptiles.
In May 1987, EPA issued PR Notices 87-4 and 87-5 in
response to OES findings that certain pesticides, including
terbufos, jeopardized the continued existence of endangered
species. Those PR Notices directed registrants to add labeling
to their products which referred users to additional information
that, in turn, explained limitations on use of terbufos within
the range of jeopardized endangered species.
Subsequent to issuance of these PR Notices, EPA
identified a number of significant technical errors and incon-
sistencies in the information to which users would have been
referred. Therefore, on January 26, 1988, the Agency issued
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PR Notice 88-1, which withdrew PR Notices 87-4 and 87-5 pending
development of a more focused program to protect endangered
species. EPA is working to correct these errors prior to requiring
labeling to protect endangered species. When that program is
fully developed, notice of any labeling necessary to protect
endangered species will be issued.
4. The Agency is imposing a 7-day reentry interval on
an interim basis pending submittal and evaluation of the required
reentry data and the special 21-day dermal study. This reentry
labeling restriction is being imposed for the use of terbufos
on corn as an aerial application and as a broadcast (without soil
incorporation) application.
• Rationale: Current data are not adequate to establish
a definitive reentry interval. Establishment of an interim
reentry interval is based on the high acute toxicity properties
of technical grade terbufos and the high likelihood of exposure
to terbufos residues of workers who perform activities in the
treated site specified above. Refer to Section B.9. in Chapter
III of this document- for a discussion of the available reentry
data and an assessment of the occupational exposure risk.
5. The Agency is imposing additional worker safety and
protective clothing statements for EPs containing terbufos.
Rationale: Though the Agency has had no recent reports
of terbufos poisoning incidents, it is concerned that exposure
could present a health risk to agricultural workers due to the
high acute toxicity of terbufos. These additional protective
measures are being imposed to minimize this exposure.
6. The Agency is imposing a restriction against use of
terbufos as an aerial or broadcast application on seed corn prior
to any detasseling operations.
Rationale: This restriction is based on the high
acute toxicity properties of technical grade terbufos and the
high likelihood of exposure to terbufos residue of workers who
perform detasseling activities in seed corn fields treated with
an aerial or broadcast (without incorporation) application of
terbufos.
7. A special 21-day dermal study in rats is required to
support the continued .registration of terbufos as an aerial or
broadcast application on corn.
Rationale; This study is needed for the completion of
the Agency's assessment of the potential risk to field workers
reentering fields following aerial or broadcast treatment without
soil incorporation with terbufos. Refer to Section B.8. in
Chapter III of this document for a discussion of the potential
risks based on available data.
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8. The Agency is deferring decisions concerning terbufos1
potential for contaminating ground water until information on the
environmental characteristics and fate have been submitted and
reviewed.
Rationale: The Agency is unable to complete its
assessment of the potential for terbufos to contaminate ground
water because the mobility characteristics of this chemical are
largely unknown. Soil column leaching and field dissipation
data are incomplete and additional data are required. The
limited data available appear to indicate that under most
environmental conditions terbufos would be unlikely to leach
to ground water in measurable quantities. The available data
indicate that terbufos is not hydrolytically persistent with a
half-life of 2.2 weeks.
9. In order to meet the statutory standard for continued
registration, the Agency has determined that terbufos products
must bear revised and updated fish and wildlife toxicity warnings.
Specific wording is given in Section IV.D.
*
Rationale; Available data indicate that terbufos is
highly toxic to birds, fish, aquatic invertebrates, small mammals,
and reptiles.
10. The Agency is retaining the Restricted Use classification
for the currently registered 15 percent granular product.
Rationale; The Restricted Use classification was
imposed under the 1983 Terbufos Registration Standard, as amended
on February 27, 1985, based on the high acute oral and dermal
toxicity to humans. There is no scientific basis for changing
the classification of terbufos.
11. The Agency has identified certain data that will
receive immediate review when submitted.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger the
need for further studies which should be initiated as soon as
possible.
The following studies have been identified to receive
priority review either as soon as they are received by the Agency
or as otherwise indicated below:
Data and When Reviewed Reason
Toxicology
Special 21-day Dermal Study in Rats Assessment of
reentry risk
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Data and When Reviewed
83-3 Rabbit Teratology
Environmental Fate/Exposure
(Upon receipt of all five studies)
161-2 Photodegradation in Water
161-3 Photodegradation in Soil
162-2 Anaerobic Soil Metabolism
163-1 Leaching
164-1 Soil Dissipation
165-2 Volatility (lab)
Reentry Protection
132-1 Foliar Dislodgeable Residue
Dissipation in New Mexi-co
Residue Data
171-4 Animal Metabolism in Ruminants
and Poultry
Wildlife and Aquatic Organisms
71-5 Field Testing - Mammals and
Birds
72-3 Acute Toxicity to Estuarine
and Marine Mammals (upon
receipt of both 72-3 and
72-4)
72-4 Fish Early Life Stage
*&'
72-7 Field Testing-Aquatic
Organisms
Reason
Tolerance
assessment
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Tier study
Assessment of
reentry exposure
Tiered study
Avian risk
concern
Tier study
Tier study
Aquatic organism
risk concern
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12. While data gaps are being filled, currently registered
MPs and EPs containing terbufos may be sold, distributed, formulated,
and used, subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop additional
data, as specified in the Data Appendices, in order to maintain
existing registrations.
Rationale: Even when authorized under FIFRA sections
3(c)(2)(B) and 3(c)(7) the Agency may elect not to cancel or with-
hold registration though data are missing or are inadequate.
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory actions
are necessary.
B. Criteria for Registration
To be registered or reregistered under this Standard,
products must contain terbufos, bear required labeling, and
conform to the product composition, acute toxicity limits, and
use pattern requirements listed in
this section.
C. Acceptable Ranges and Limits '
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain terbufos.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing terbufos provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The EPA Index to
Pesticide Chemicals lists all registered uses, as well as }
approved maximum application rates and frequencies.
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-Terrestrial, non-domestic, food uses on:
corn: grain sorghum- and sugar beets.
D. Labeling
In order to remain in compliance with FIFRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and this Standard, or must be revised to conform to those
specifications. Appendix II contains information on label
requirements.
No pesticide product containing terbufos may
be released for shipment by the registrant after November,
1989, unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing terbufos may be distributed
or sold after November, 1990 unless the product bears an amended
label which complies with the requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient as:
Terbufos : S-[[(1,1-dimethylethyl)thio]methyl]
0,0-diethyl phosphorodithioate %
2. Use Pattern Statements
All manufacturing-use products 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 C.3. However, no use may be included on
the label where the registrant fails to agree to comply with the
data requirements in TABLE A for that use pattern.
Labels for MPs must bear the following identifying
phrase directly beneath the product name:
"An insecticide and nematicide *j£or formulating
use only."
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In the directions for use, the following
statement regarding acceptable use patterns must appear on
MP labels:
"For formulation into end-use insecticide
and nematicide products intended only for (list
acceptable sites)."
NOTE: No use may be included on the label where the
registrant fails to agree to comply with the data
requirements for that use pattern. Refer to Section
B; Use Profile in Chapter II for the acceptable
sites.
3. Precautionary Statements
Statements for Manufacturing-Use Products
a. The following fish and wildlife statements are
required to appear under the "Environmental Hazards" heading:
This pesticide is extremely toxic to fish and
wildlife. 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 a
National Pollution Discharge Elimination System (NPDES) permit.
Do not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant authority.
For guidance, contact your State Water Board or the Regional
Office of EPA.
Statements for End-Use Products
a. The following work safety rules and protective
clothing statments must appear on the label of end use products:
WORK SAFETY RULES
REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SENSITIVITY TO VERY SMALL DOSES OF ANY CHOLINESTERASE INHIBITOR.
Persons working with this product should have frequent blood
tests of their cholinesterase levels. If the cholinesterase
level falls below a critical point, no further exposure should
be allowed until it has been determined by means of blood tests
that the cholinesterase level has returned to normal. Before
using this product, consult the National Pesticide Telecommuni-
cation Network for recommendations regarding such blood tests,
poisoning management, emergency treatment, and other information
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regarding the toxicity of terbufos. The toll-free number for the
National Pesticide Telecommunication Network is 1-800-858-7378.
If handled indoors, provide mechanical exhaust ventilation.
Keep all unprotected persons, children, livestock, and pets
away from treated areas or where there is danger of drift.
Do not rub eyes or mouth with hands. If you feel sick in any
way, STOP work and get help right away. See First Aid (Practical
Treatment) section.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING LOADING,
APPLICATION, EQUIPMENT REPAIR, EQUIPMENT CLEANING, AND DISPOSAL
OF THE PESTICIDE.
Wear a protective suit of one or two pieces that covers all
parts of the body except the head, hands, and feet. Wear chemical-
resistant gloves and chemical-resistant shoes, shoe coverings, or
boots. > Wear goggles and a pesticide respirator approved by the
National Institute for Occupational Safety and Health (NIOSH) and
the Mine Safety and Health Administration (MSHA) at all times
except during application.
If application is performed using an enclosed cab or cockpit,
the following protective clothing may be worn as an alternate:
long-sleeved shirt and long-legged pants; shoes and socks.
Chemical resistant gloves must be available in the cab or cockpit
and must be worn while -exiting. All other protective clothing
required for use during application must be available in the cab
and must be worn when exiting the cab into treated areas.
IMPORTANT! Before removing gloves, wash them with soap and
water. Always wash hands, face, and arms with soap and water
before smoking, drinking, or toileting.
IMMEDIATELY AFTER COMPLETING WORK WITH THE PESTICIDE, take
off all clothing and shoes. Shower using soap and water. Do not
reclothe with contaminated clothing and shoes. Wash protective
clothing and protective equipment with soap and water after each
use. Respirators must be cleaned and filters replaced according
to instructions included with the respirators. Personal clothing
worn during use must be laundered separately from household
articles. Clothing and protective equipment heavily contaminated
with terbufos must be destroyed according to State and local
regulations. HEAVILY CONTAMINATED CLOTHING (CLOTHING ON WHICH
THE PRODUCT HAS SPILLED) CANNOT BE ADEQUATELY DECONTAMINATED.
4
DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED
UNLESS IN A TOTALLY ENCLOSED VEHICLE.
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b. The following reentry statement and worker
protective clothing statements must appear on all products intended
for aerial application or broadcast application to corn:
"Reentry into treated areas is prohibited for
7 days after the end of application unless the protective clothing
specified on this label for early reentry is worn."
"FOR EARLY REENTRY INTO TREATED AREAS: Use
protective suit of one or two pieces covering all parts of the
body except head, hands, and feet; chemical-resistant gloves and
chemical-resistant shoes, shoe coverings, or boots."
c. The following restriction must appear on products
intended for aerial or broadcast treatment for corn seed crops:
"Do not use prior to any detasseling operations."
d. The following environmental hazards statements
must appear on all end-use products:
"This pesticide is extremely toxic to fish and
wildlife. Birds, and mammals utilizing treated fields may be
killed."
"Do not apply directly to water or wetlands
(including swamps, marshes, bogs, and potholes). Runoff and
drift from treated areas may be hazardous to aquatic organisms
in adjacent aquatic sites. Do not contaminate water when disposing
of equipment washwaters. Cover or incorporate granules that are
spilled during mixing and loading."
6. The following statement must appear on all end-use
products containing terbufos"
"Not for use or storage in or around the home."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by an end use producer who is eligible
for the generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption3, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data require-
ments listed in. Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption,
the data requirements listed in Tables A and C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the generic data exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to the data
requirements in Table A.
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2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a generic data 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 Generic Data Exemption
Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted,'any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
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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 submittal.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the.con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
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2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant.will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data,
4. You request a waiver of the data requirement. If
you believe that a data requirement 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. The Agency will respond in writing
to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
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6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
All studies reqaired under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
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G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols. The
Agency will respond in writing to your request for protocol
approval or change.
H. 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.
EPA will view failure to request an extension before
the data submittal 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. The Agency
will respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
^Included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submittal requirement.
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J. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant 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 consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard. Responses to this Registration Standard must
include draft labeling for Agency review.
Labeling must 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. 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.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: [TERBUFOS] Registration Standard
All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
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a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
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.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table Af you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8530-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
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notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or_ the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
-41-
-------
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
-42-
-------
I. DATA APPENDICES
43
-------
-------
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.
j
^
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment
Guidelines, which are available from the National Technical
Information Service, 5285 Prot 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
44
-------
F =• Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
N/A= There are no registered use patterns for which the
data requirement applies.
•
Any other designations will be defined in a footnote to the
table. ,
4. Does EPA have data? (Column 4). This column indicates
one of three answers:
- 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 riot 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 information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the
identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a GS
number if no MRID number has been assigned. Refer to the
Bibliography Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data; this column will usually indicate NO. If column e
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not 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
45
-------
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 t
requires that data be submitted, this column indicates when
the data are- to be submitted, based on the issuance date of
the Registration 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.
46
-------
-------
Table A
Generic Data Requirements for Terbufos
Test Use
Data Requirement Substance Patterns
§158.190 Product Chemistry
Product Identity
61-2 - Description of Beginning
Materials and
Manufacturing Process
61-3 - Discussion of Formation
of Impurities
TGAI
TGAI
Analysis and Certification of Product
t
62-1 - Preliminary Analysis of
Product Samples
TGAI
All
All
Ingredients
All
Must Additional Timeframe
Does EPA Bibliographic Data Be for
Have Data?1/ Citation2/ Submitted? Submissions/
Partial 00147534 Yes_4/
No — YesV
No — Yes6/
6 Months
6 Months
12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
All
All
All
All
TGAI All
No — YesT/
No — YesJV
Ho ~ YesV
N/A No8/
Yes 00142295 No
6 Months
6 Months
6 Months
00147534
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Data Requirement
Must Additional
Test Use Does EPA Bibliographic Data Be
Substance Patterns Have Data?"1/ Citation^/ Submitted?
Timeframe
for
Submissions/
§158.190 Product Chemistry
Physical and Chemical Characteristics (cont'd)
TGAI All
63-7 - Density, Bulk Density,
or Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-12 - pH
63-13 - Stability
Other Requirements
64-1 - Submittal of Samples
TGAI or PAI All
PAI
PAI
63-11 - Octanol/Water Partition PAI
Coefficient
TGAI
TGAI
All
All
All
All
All
No
Yes
Yes
No
Yes
Partial
No
00142295
00142295
00142295
00142295
YesV
No
No
NoV
No
Yes7/f10/
Yes7/
6 Months
6 Months
6 Months
N/A
_1/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable. However, data submitted for
the technical terbufos, registered under EPA Registration No. 241-241 in response to the requests made in the
Terbufos Registration Standard dated June 1983, have been evaluated with regard to their adequacy in meeting the
, requirements of 40 CFR 158.120.
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.190 Product Chemistry Footnotes (cont'd)
2/ These data citations pertain to the technical terbufos currently registered under EPA Registration No. 241-241 and
may not be applicable to technical material which differs from that described herein.
_3/ Due dates refer to the number of months following the issuance of this Registration Standard, unless otherwise
indicated.
V Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
j>/ A detailed discussion must be submitted of all toxicologically significant impurities and' all other impurities
that are or may be present at >_ 0.1% by weight, based on knowledge of the beginning materials, chemical
reactions (intended and side) in the manufacturing process, and any contamination during and after production.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
7/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, and stability) as required
in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D must be
submitted.
_§/ Not applicable; technical product is a liquid at room temperature.
9/ Not applicable to the terbufos technical product.
10/ Required if the test substance is dispersible with water.
-------
Table A
Generic Data Requirements for Terbufos
Data
§158.
171-2
171-3
171-4
171-4
171-4
Test Does EPA
Requirement Substance Have Data?
240 Residue Chemistry
- Chemical Identity^/
- Directions for Use (See Index)
- Nature of the Residue PAIRA Yes
(Metabolism)
- Plants
- Nature of the Residue PAIRA and
(Metabolism) plant
- Animals metabolites
a. Rats Yes
b. Ruminants Partially
c. Poultry No
d . Swine No
- Residue Analytical TGAI and Partially
Methods metabolites
Must Additional
Bibliographic Data Be Timeframe for
Citation Submitted? SubmissionV
00036123,00062871, No
00069512,00079429,
00087686,00087688,
00087689,00087691,
00087692,00088210,
00131237,00133299
00087695 NO
00032636,00036241 YesJV 18 Months
Yes3/ 18 Months
ReservedV
00036123,00036127, YesjS/ 15 Months
00036129,00032646,
00036241,00036242,
00036246,00042020,
00042022,00049235,
00062872,00079431 ,
00087687,00087702,
00087704,00087724,
00088211,00129173,
00133299,00158614,
C
Lf
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe for
Submission1 /
§158.240 Residue Chemistry
171-4 - Storage Stability Data TEP and
metabolites
171-4 - Magnitude of the Residue
Crop Field Trials
- Root and Tuber Vegetables
Group
Sugar Beet Roots TEP
- Leaves of Root and Tuber
Tuber Vegetables Group
- Sugar Beet Tops TEP
- Cereal Grains Group
- Corn TEP
- Corn (processed) TEP
- Sorghum TEP
- Sorghum (processed) TEP
Partially 00042021
Partially
No
Partially
No
00039018,00042017,
00042019,00087722,
00137582,GS0109001
00079430
Yes6/
Partially 00036124,00036123, YesV
00036129
Partially 00036124
Yes13/
Yes 1V
15 Months
18 Months
18 Months
18 Months
24 Months
18 Months
24 Months
LO
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe for
Submissionl/
§158.240 Residue Chemistry
171-4 - Magnitude of the Residue
Crop Field Trials (cont'd)
- Forage, Fodder, and Straw
of Cereal Grains Group
- Corn TEP
- Sorghum TEP
171-4 - Magnitude of Residue in
Meat/MiIk/Poultry/Eggs
Partially
Partially
Partially
00039018,00042017,
00042019,00087722,
00137582,GS0109001
00079430
00032636,00036241,
00087702
YesT7/
Reserved18/
18 Months
18 Months
C\J
_1/ Due dates refer to the number of months following issuance of this Registration Standard unless otherwise
indicated.
2/ The same chemical identity data are required as under §158.120, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
_3/ Metabolism studies using ruminants and poultry must be submitted. Animals must be dosed for at least 3 days
with methylene-labeled [14c]terbufos at a level high enough to permit identification and quantification of
14c-residues. Milk and eggs must be collected twice daily during the dosing period. Animals must be
sacrificed within 24 hours of the final dose. The distribution and characterization of residues must be
determined in milk, eggs, liver, kidney, muscle, and fat. Samples from these studies must also be analyzed
using enforcement methods (including all FDA Multiresidue Protocols tl-IV]) to ascertain that the methods are
capable of adequately recovering and quantifying all residues of toxicological concern.
_4/ Data depicting the nature of terbufos residues in swine are also required if the required metabolism studies
with ruminants and poultry reveal that the metabolism of terbufos in these animals differs from that in rats.
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
5/ Residues of terbufos must be tested in representative plant commodities by multiresidue protocol IV (available
from NTIS under Order No. PB 86203734/AS). Also, each of the phosphorylated metabolites listed in the proposed
tolerance definition must be tested by all four multiresidue protocols. In addition, methodology validation data
pertaining to recovery of these individual metabolites from additional representative plant commodities are
required. Additional analytical data for detection of terbufos residues of concern in animal products may be
necessary upon receipt and evaluation of the animal metabolism data as described in footnotes three and four of
this table.
6/ Data depicting the stability of terbufos residues of concern in or on sugar beet roots and sugar beet tops are
required. Samples bearing field-weathered residues or fortified samples must be analyzed immediately after
harvest or fortification and again after storage intervals that are equivalent to those reflected in all previously
submitted and currently requested residue data. Storage conditions for the samples must also reflect previously
submitted and currently requested data. The chosen storage intervals must allow for unforeseen delays in sample
analysis. Data depicting the storage stability of each separate metabolite as listed in the proposed tolerance
definition are required. Upon receipt of the requested animal metabolism data, the need for storage stability
data pertaining to terbufos residue of concern in animal tissues will be addressed.
7/ The registrant must propose an appropriate tolerance for residues of terbufos and its cholinesterase-inhibiting
metabolites in or on sugar beet roots based on data reflecting residues of terbufos in or on sugar beet roots
harvested at normal crop maturity following at-planting application of the 15% G formulation at 4.4 Ib ai/field
A (2.7 oz ai/1000 ft of row, 20-inch row spacing) drilled in 2 inches to the side and 2 to 4 inches below the
seed. Tests must be conducted in CA(23%), MN(20%) or ND(10%), ID(15%), and NE(7%) or CO(4%) or WY(3%)
representing ca. 80% of 1985 U.S. sugar beet production (Agricultural Statistics 1986, p. 76). The registrant
must propose label amendments establishing a PHI for the postemergence banded application; this PHI must be
reflected by the residue data submitted.
8/ The registrant must propose an appropriate tolerance for residues of terbufos and its cholinesterase-inhibiting
metabolites in or on sugar beet tops based on data depicting residues in or on sugar beet tops harvested at
regular intervals through normal crop maturity following at-planting application of the 15% G formulation at 4.4
Ib ai/field A (2.7 oz ai/1000 ft of row, 20-inch row spacing) drilled in 2 inches to the side and 2 to 4 inches
below the seed. Tests must be conducted in CA(23%), MN(20%) or ND(10%), ID(15%), and NE(7%) or CO(4%) or WY(3%)
representing ca. 80% of 1985 U.S. sugar beet production (Agricultural Statistics 1986, p. 76). The registrant
must propose label amendments establishing a PHI; this PHI must be reflected in the data requested above and in
all other data used to support the tolerance.
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
£/ Data are required depicting terbufos residues of concern in or on grain from field corn planted in 30-inch rows
and harvested at normal crop maturity following application of the 15% G formulation in a band at-planting at
1.2 oz ai/1000 ft of row and incorporated postemergence in a band at 2.4 -oz ai/1000 ft of row (3.9 Ib ai/field
A seasonal use rate). Tests must be conducted in IL(17%) or IA(19%), IN(9%) or MI(3%) or OH(6%), MN(8%) or
WI(4%), and NE(11%) or KS(2%) collectively representing ca. 80% of 1985 U.S. corn production (Agricultural
Statistics, 1986, p. 32).
10/ Data are required depicting terbufos residues of concern in or on grain of field corn grown in 30-inch rows and
harvested 45 days after the last of three applications of the 15% G formulation, including a banded application
at-planting of 1.2 oz ai/1000 ft of row, a postemergence banded application at cultivation at 1.2 oz ai/1000 ft
of row, and a postemergence broadcast application of 1 Ib ai/A applied by aerial or ground equipment (seasonal
use rate of 3.6 Ib ai/field A). Tests must be conducted in IA, NE, and NM, the States having SLN registrations
that allow the postemergence broadcast applications. Alternatively, the registrant may elect to cancel the SLN
registrations for postemergence broadcast use on field corn.
11/ Data are required depicting terbufos residues of concern in or on K+CWHR from sweet corn planted in 30-inch rows «^j-
and harvested at the PHI following the last of two applications of the 15% G formulation including a banded IT)
application at-planting of 1.2 oz ai/1000 ft of row and a postemergence incorporated banded application of
2.4 oz ai/1000 ft of row (3.9 Ib ai/field A seasonal use rate). Tests must be conducted in the States of FL(7%),
IL(6%), MN(20%) or WI(20%), and OR(10%) or WA(10%) collectively representing ca. 70% of 1985 U.S. sweet corn
production for fresh market and processing (Agricultural Statistics 1986, p. 156). The registrant must propose
label amendments establishing a PHI for sweet corn K+CWR that is reflected in the data requested above. The data
requested for field corn grain will be translated to support the tolerance for popcorn grain.
12/ A processing study is required depicting terbufos residues of concern in products (starch, crude oil and refined
oil from wet milling; grits, meal, flour, crude oil and refined oil from dry milling; and grain dust) processed
from field corn grain bearing measurable, weathered residues. If residues concentrate in any product,
appropriate food/feed additive tolerances must be proposed.
13/ Data are required depicting residues of terbufos and its cholinesterase-inhibiting metabolites in or on grain
from sorghum planted in 20-inch rows and harvested at normal crop maturity following a single application of the
15% G formulation at 2.4 oz ai/1000 ft of row (3.9 Ib ai/field A). The insecticide must be drilled in at bedding
or at-planting 1 to 4 inches below and 0 to 5 inches to the side of the seed. Tests must be conducted in
KS(20%), MO(11%), NE(14%), and TX(22%), collectively representing ca. 70% of 1985 U.S. grain sorghum production
(Agricultural Statistics 1986, p. 52).
14/ A processing study is required depicting terbufos residues of concern in flour, starch, and grain dust processed
from sorghum grain bearing measurable weathered residues. If residues concentrate in any product, appropriate
food/feed additive tolerances must be proposed.
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
j_5/ Data are required depicting terbufos residues of concern in or on forage and fodder of field corn grown in 30-inch
rows and harvested 30 days after application of the 15% G formulation banded at-planting at 1.2 oz ai/1000 ft of
row and incorporated postemergence in a band at 2.4 oz ai/1000 ft of row (seasonal use rate of 3.9 Ib ai/field
A). Tests must be conducted in IL(17%) or IA(19%), IN(9%) or MI(3%) or OH(6%), MN(8%) or WI(4%), and NE(11%) or
KS(2%) collectively representing ca. 80% of 1985 U.S. corn production (Agricultural Statistics 1986, p. 32).
16/ Data are required depicting terbufos residues of concern in or on forage and fodder of field corn grown in 30-
inch rows and harvested 45 days after the last of three applications of the 15% G formulation, including a banded
application at-planting of 1.2 oz ai/1000 ft of row, a postemergence banded application at cultivation of 1.2 oz
ai/1000 ft of row, and a postemergence broadcast application of 1 Ib ai/A applied by aerial or ground equipment
(seasonal use rate of 3.6 Ib ai/field A). Tests must be conducted in IA, NE, and NM, the States having SLN
registrations that allow the postemergence broadcast applications. Alternatively, the registrant may elect to
cancel the SLN registrations for postemergence broadcast use on field corn.
17/ Data are required depicting residues of terbufos and its cholinesterase-inhibiting metabolites in or on forage
and fodder of sorghum grown in 20-inch rows and harvested at the PHI/PGI following a single application of the K2
15% G formulation at 2.4 oz ai/1000 ft of row (3.9 Ib ai/field A). The insecticide must be drilled in at bedding
or at-planting 1 to 4 inches below and 0 to 5 inches to the side of the seed. The registrant must propose label
amendments establishing a PGI/PHI that is reflected in the data requested above. Tests must be conducted in
KS(20%), MO(11%), NE(14%), and TX(22%), collectively representing ca. 70% of 1985 U.S. grain sorghum production
(Agricultural Statistics 1986, p. 52). '
18/ Upon receipt of the required animal metabolism data, the need for and nature of tolerances for residues of
terbufos and its cholinesterase-inhibiting metabolites in meat, milk, poultry, and eggs will be reevaluated.
-------
Table A
Generic Data Requirements for Terbufos
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data Be Submitted?
Timeframe for
Submissionl/
§158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Mobility Studies:
163-1 - Leaching and
Absorption/
Desorption
163-2 - Volatility (lab)
163-3 - Volatility
PAIRA A Yes 00087694
PAIRA A Partial 000161567
PAIRA or TGAI A No
PAIRA or TGAI A No.
PAIRA A Yes 00156853
PAIRA or TGAI A No
PAIRA or TGAI — No
PAIRA or TGAI — No
PAIRA A NO
TEP A No
TEP A No
No
Yes2/
YesjJ/
Yes_3/
No
YesV
NoV
No6/
YesV
Yes£/
Reserved 9/
9 Months
9 Months
9 Months
27 Months
12 Months
12 Months
LO
(field)
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Test Use Does EPA Bibliographic
Data Requirement Substance Pattern Have Data? Citation
§158.290 Environmental Fate
Dissipation Studies - Field:
164-1 - Soil TEP A No
164-2 - Aquatic (Sediment) TEP — No
164-3 - Forestry TEP — No
1 64-4 - Combination and — No —
Tank Mixes
164-5 - Soil, Long-Term TEP — No
Accumulation Studies:
165-1 - Rotational Crops PAIRA A Yes 00087692
(Confined)
165-2 - Rotational Crops TEP A Partial 000161568
(Field) • 000161569
165-3 - Irrigated Crops TEP — No
165-5 - In Fish PAIRA/TGAI A No
163-5 - In Aquatic TEP — No
Must Additional Timeframe for
Data Be Submitted? Submissionl/
YesH)/ 27 Months
No6/
NoJM/
NoJ_2/
Reservedl 3/
No
Yes^j4/ 50 Months
NoJIS/
Yesj_6/ 12 Months
No5/
Nontarget
Organisms
Monitoring Studies;
Soil, Water, Sediment,
and Fish
TEP
No
Yes17/
6 Months
(acceptable
protocol)
ID
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.290 Environmental Fate Footnotes
I/ Due dates refer to the number of months following issuance of this Registration Standard unless otherwise
indicated.
2/ Full information is needed on light source spectral characteristics, use and effect of filters, and comparison
with natural sunlight. Also, the T 1/2 of the dark control vis a vis the hydrolysis T 1/2 and the pH of the
solutions is needed before the study can be accepted.
_3/ This study is required to support the current method of nonsoil-incorporated, broadcast (ground or aerially)
application of the granular formulation.
j4/ The study must be repeated due to low residue recoveries (material balance); also, the study should use terbufos
i^C-labeled in two sites to detect all degradates. The study is needed so that all the degradates present are
known and can be looked for in the field dissipation study.
5/ This study is not required to support the current use pattern which does not include aquatic, forestry, or
aquatic impact uses.
6/ This study is not required to support the current use pattern which does not include aquatic or aquatic impact
uses.
7/ This study must be repeated due to low residue recovery for the aged and imaged studies (< 60% of applied). Such
poor recovery prevents us from knowing if significant amounts of residues leached. An aged column leaching study
using sand or loamy sand plus one other representative soil is required. Samples must be analyzed for both terbufos
and its sulfone and sulfoxide degradates.
8/ This study is required unless the vapor pressure of the TEP (granular formulation) is less than ICT^ mmHg.
9/ This study is reserved pending the results of the lab volatility study.
10/ This study is required because of the many deficiencies of the reviewed studies, an important one being that the
first sampling was taken 40 days posttreatment, by which time > 85% of terbufos dissipated. This deficiency is
important because of the lack of information we have on leaching, and its relatively long aerobic soil half-life
for parent/degradates. Samples were only taken to a depth of 6 inches and residues were present at the 3 to 6
inch depth. Samples must be analyzed for both terbufos and its sulfone and sulfoxide degradates.
ll/ This study is not required to support the current use pattern which does not include forestry uses.
12/ There are no current registered combination or tank mixes for terbufos.
13/ The requirement for this study is reserved pending the results of the field dissipation study (§164-1).
14/ The two studies may be acceptable provided sample storage stability data are supplied.
15/ This study is not required to support the current use pattern which does not include aquatic uses.
16/ This study must be repeated because the treated soil was aged 30 days before adding water and fish, the test
material exceeded 1/10 LC50, and a flow-through system was not used to maintain a level concentration of
terbufos. The study is required to determine if accumulation in fish occurs since terbufos is very toxic to fish
and the corn/sorghum use has the potential to reach fish in ponds.
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.290 Environmental Fate Footnotes (cont'd)
17/ The objective of this monitoring requirement is to measure actual residues of terbufos and metabolites in treated
fields and in ponds adjacent to fields where terbufos is used.
The majority of terbufos marketed is used for corn rootworm control and it seems likely that environmental concerns
will arise in the corn growing areas of the U.S. The application sites chosen should possess a known application
history and be adjacent to ponds. Geographic areas for sampling should include: corn belt States, plain States,
and lake States.
Soil in treated fields should be monitored before and after application of terbufos. Pond water, sediment, and
fish should be monitored before and after fields are treated with terbufos. The scheme of monitoring (where,
when, how) should reflect the attempt to measure maximum residues. Fish samples should be analyzed for choline-
sterase inhibition, as well as terbufos residues. Baseline cholinesterase levels in fish brains should be
established both in the ponds at the treatment sites and in an area without any history of anticholinesterase
pesticide use (e.g., ponds near pastureland, but not where hay is harvested). The pH-stat technique as described
by Coppage (1971) should be used. Metabolites as well as parent levels should be monitored (Cook, et al., 1976).
Additional information on this type of field study can be found in Tagatz, et al., (1974) and Coppage and Braidech
(1976). Treatment rates should be at highest label rate for that site and crop. Normal agricultural practices
should be followed, including repeated applications, if appropriate. If possible, some sites with a history of
terbufos treatment should also be chosen.
The monitoring protocol (including analytical methodology) must be submitted to the Agency, prior to initiating
the study.
-------
Table A
Generic Data Requirements for Terbufos
Data
§158.
Acute
81-1
81-2
81-3
81-7
Test
Requirement Substance
340 Toxicology
Testing:
- Acute Oral - Rat TGAI
- Acute Dermal - Rabbit TGAI
- Acute Inhalation - Rat TGAI
- Acute Delayed Neuro- TGAI
toxicity - Hen
Use Does EPA Bibliographic Must Additional Timeframe for
Pattern Have Data? Citation Data Be Submitted? Submission V
\
A Yes 00037467*, 00037471* No
000351 21**, 00029863**,
A Yes 00144805 No
A Yes 00144806 No£/
A Yes 00037472,00045379 No
Subchronic Testing:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding
- Rodent TGAI
- Nonrodent TGAI
- 21 -Day Dermal TGAI
- 90 -Day Dermal TGAI
- 90-Day Inhalation TGAI
- 90-Day Neurotoxicity TGAI
A Yes 00109446,00037469 No
A No No3/
A Partial 00085169 YesjV 12 Months
A No NoV
A No No6/
A No NoV
o
VO
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Timeframe for
Data Be Submitted? Submission"!/
§158.340 Toxicology
Chronic Testing:
83-1 - Chronic Toxicity
83-2
83-3
83-4
- Rodent
- Nonrodent
- Oncogenicity Study
- Rat
- Mouse
- Teratogenicity
- Rat
- Rabbit
- Reproduction
3-Generation
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A '
A
Yes
Yes
Yes
Yes
Yes
No
Yes
00045378,00049236
40089602
40374701,00161572
00045378,00049236
40089603
00147533
00085172,00037473
No8/
Nq9/
No
No
No
Yes
No
Mutagenicity Testing:
84-2
84-2
84-2
- Gene Mutation
- Chromosomal Aberration
- Other Mechanisms of
TGAI
TGAI
TGAI
A
A
A
Yes
Yes
Yes
00063209
00161570
00161571
No
No
No
15 Months
Mutagenicity
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
Test Use Does EPA Bibliographic Must Additional Timeframe for
Data Requirement Substance Pattern Have Data? Citation Data Be Submitted? Submissionl/
§158.340 Toxicology
Special Testing;
85-1 - General Metabolism PAI or PAIRA A Yes 00087695 No
85-2 - Domestic Animal Choice A No — No10/
Safety
CNJ
jy Due dates refer to the number of months following issuance of this Registration Standard unless otherwise \O
indicated.
2/ A 21-day repeated inhalation study fulfills the acute requirements.
3/ This study is not required because a long-term study is available.
4/ The available 21-day dermal study in rabbits is acceptable. However, an additional 21-day dermal study to be
conducted with rats is required to support the registered use of terbufos as a nonsoil-incorporated application
(using aerial or ground equipment) to corn. Red blood cell and serum cholinesterase levels should be measured
after the first dose and at study termination (21 days after the start of the study) in order to establish a
cholinesterase NOEL. In addition, brain cholinesterase levels should be measured at the time of terminal
sacrifice (21 days). Selection of dose levels is at the discretion of the registrant.
5/ This study is not required to assess the dermal exposure associated with the current pesticidal use of terbufos.
6/ This study is not required. It is unlikely that the current pesticidal use of terbufos will involve repeated
inhalation, i.e., as granular formulations.
]_/ This test is not required because the results of the acute delayed neurotoxicity test were negative.
8/ The 1-year rat study (40089602) combined with the 2-year rat study (00045378 and 00049236) satisfy this 83-1
data requirement for the rodent.
9/ A 4-week dog study submitted to establish a NOEL for plasma cholinesterase inhibition (40374701) combined
with the 1-year dog study (0016175) satisfies this 83-1 data requirement for the nonrodent.
W/ Testing is not required based on current registered uses. However, depending on the extent of future use in feed
items and whether or not tolerances would be requested in meat and milk, a combined study can be performed for
both residues and' domestic animal safety determinations.
* Data citations 00037467 and 00037471, combined, satisfy this data requirement for the technical material registered
under EPA Registration No. 241-241.
** Data citations 00035121 and 00029863 satisfy this data requirement for the technical material currently pending
under EPA File Symbol 2749-UEL.
-------
Table A
Generic Data Requirements for Terbufos
Test Use Does EPA Bibliographic
Data Requirement Substance Pattern Have Data? Citation
Must Additional Timeframe for
Data Be Submitted? Submission1/
§158.390 Reentry Protection
132-1
132-2
133-3
133-4
- Foliar Dissipation TEP A Partial 00137760
- Soil Dissipation TEP A No
- Dermal Exposure TEP A Partial 00137760
- Inhalation Exposure TEP A Partial 00137760
Yes2/ 27 Months
NoV
NoV
NO4/
§158.440 Spray Drift
201-1 - Droplet Size Spectrum TEP A
202-1 - Drift Field Evaluation TEP A
No
No
No
V
\0
1/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
indicated.
2/ The submitted study is acceptable for use in the estimation of field worker exposure to terbufos residues
~~ from application of the pesticide when applied in parts of the U.S. other than in California and the arid
southwest. A dislodgeable residue dissipation study to be conducted in New Mexico is required to support
continued use as an aerial or broadcast treatment in the southwestern States, i.e., where rainfall is less
than 25 inches/year.
3/ Soil dissipation data are not required for the current registered use of terbufos which does not include
uses on crops such as potatoes or peanuts where hand harvesting will be performed.
4/ Human-exposure monitoring data may be submitted at the registrant's option. If dermal exposure data are
submitted, inhalation exposure data must also be submitted.
5/ These studies are not required to support the current application of turbufos as a granular formulation.
-------
Table A
Generic Data Requirements for Terbufos
Data Requirement
Test
Substance
Use Does EPA
Pattern Have Data?
Bibliographic Must Additional Timeframe for
Citation Data Be Submitted? Submission1/
§158.490 Wildlife and Aquatic Organisms
Avian and Mammalian Testing;
71-1 - Acute Avian Oral TGAI
Toxicity
71-2 - Avian Subacute Dietary
- Upland Game Bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
Upland Game Bird
and Waterfowl
71-5 - Simulated Field Testing
and Actual Field
Testing
- Mammals and'Birds TEP
72-1 - Freshwater Fish Toxicity
- Coldwater Fish TGAI
Species TEP
A
A
Yes
TGAI
TGAI
TGAI
TGAI
A
A
N/A
A
Yes
Yes
—
Yes
Partial
Yes
Yes
00106551
00161573,00161574
00085178,00087726,
00085180,00145854,
00085179,00085183,
00131477
00087718,00037483
GS0109003
No
00087717,00160387 No
00035120 No
No
Yes2/
No
No
December 31, 1989
(1st Annual
Report)3/
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Table A
Generic Data Requirements for Terbufos (cont'd)
Test Use Does EPA Bibliographic Must Additional Timeframe for
Data Requirement Substance Pattern Have Data? Citation Data Be Submitted? Submissionl/
§158.490 Wildlife and Aquatic
72-1 -
Aquatic
72-2 -
72-3 -
72-4 -
72-5 -
72-6 -
Organisms
Freshwater Fish Toxicity (cont'd)
- Warmwater Fish
Species
Organism Testing:
Acute Toxicity to
Freshwater
Invertebrates
Acute Toxicity to
Estuarine and Marine
Organisms
Fish Early Life Stage
- Aquatic Invertebrate
Life Cycle
Fish - Life Cycle
TGAI A Yes 00087718,00037483,
00085176
TEP A Yes GS01 09002
TGAI A Yes 00101495,00085176
TEP A Yes GS01 09004
TGAI A No
TGAI A No
TGAI A • Yes 00162525
TGAI A No
Aquatic Organisms TGAI, PAI, or A No
No
No
No
No
Yes4/ 12 Months
Yes 15 Months
No
ReservedV
Yes 1 2 Months
Accumulation Degradation
Product
72-7 - Simulated Field
Testing and Actual
Field Testing
- Aquatic Organisms
TEP
No
Yes6/
6 Months
(Protocol)
in
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.490 Wildlife and Aquatic Organisms Footnotes »
_!_/ Due dates refer to the number of months following issuance* of this Registration Standard, unless otherwise
indicated.
2/ These data are sufficient to satisfy the Level I field study requirement. A Level II field study is required to
qualify the potential effects on populations of birds, mammals, and reptiles, based on the adverse effects detected
in the Level I study. The Level II study must be conducted on corn to support the current registered uses on
corn. Field studies for other use patterns are reserved, pending an evaluation of the results of the corn study and
an analysis of applicability to support other crop uses. In the event the corn use is dropped, the study must be
conducted on sorghum.
3/ The submittal due dates were set in the Agency letter of June 3, 1987 to American Cyanamid Co. and were subsequently
extended in the Agency's letter of May 9, 1988 to the company.
1st Annual Report December 31, 1989
2nd Annual Report* December 31, 1990 ^Q
3rd Annual Report* December 31, 1991 \O
Final Report** December 31, 1992
*A determination may be made at this time to conclude the study, in which case a final report will be due
3 months after notification.
**This due date applies if the study has not been determined to be concluded by earlier reviews.
4/ Though terbufos appears to be at least very highly toxic to both sheepshead minnow and mysid shrimp in the available
studies, they are not acceptable because of deviation from recommended protocols and must be repeated.
5/ The need for this study is reserved pending receipt of lower tier tests and environmental fate studies.
6/ Aquatic field studies are required to support the corn use. Field studies for other use patterns are reserved,
pending an evaluation of the results for corn and an analysis of applicability to support other crop uses. For
either mesocosm or full field studies, the study design must include appropriate techniques to determine acute
mortality and effects on productivity and diversity of fish and aquatic invertebrates. A protocol for a mesocosm
or full field study must be submitted to the Agency for review. A Guidance Document is available from the Agency,
which outlines an acceptable approach to mesocosm studies. This document also provides relevant, although
general, guidance for full field studies, which, if selected in place of mesocosm studies, must include multiple
treated ponds and control ponds. The Agency encourages registrants to consult with Ecological Effects Branch
staff for guidance as needed.
-------
Table A
Generic Data Requirements for Terbufos
Test Use Does EPA Bibliographic Must Additional Timeframe for
Data Requirement _ Substance Pattern Have Data? _ Citation _ Data Be Submitted? Submissioni/
§158.590 Nontarget Insect
Nontarget Insect Testing - Pollinators :
141-1 - Honey Bee Acute TGAI A Yes 00066220 No
Contact
141-2 - Honey Bee - Toxicity TEP A No Nq2/
of Residues of
Foliage
141-4 - Honey Bee Subacute Reserved^/
Feeding Study
141-5 - Field Testing for TEP A No No2/
Pollinators
Nontarget Insect Testing - Aquatic Insects;
142-1 - Acute Toxicity to Reserved^/
Aquatic Insects
142-2 - Aquatic Insect Life Reserved^/
Cycle Study
142-3 - Simulated or Actual Reserved^/
Field Testing for
Aquatic Insects
143-1 - NONTARGET INSECT Reserved^/
thru TESTING - PREDATORS
143-3 AND PARASITES
-------
Table A
Generic Data Requirements for Terbufos (cont'd)
§158.590 Product Chemistry Footnotes
_!/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
indicated.
2/ Since the current registered uses of terbufos will not result in bee exposure, honey bee testing beyond the first
level (acute contact LD50) is not required.
3/ Reserved pending development of test methodology. Also refer to footnote^/.
4/ Reserved pending decision as to whether the data requirement should be established.
CO
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos
Test
Data Requirement Substance
§158.190 Product Chemistry
Product Identity
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning MP
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP
of Impurities
Use
Patterns
All
All
All
Does EPA Bibliographic Must Additional
Have Data?1/ Citation2/ Data Be Submitted?
No Yes4/
Partial 00147534 Yes5/
No YesjS/
Timef rame
for
Submissions/
6 Months
6 Months
6 Months
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to
Verify Certified Limits MP
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
All
All
All
All
All
All
No Yes_7/
No YesjJ/
No Yes9/
No — YeslO/
No — YeslO/
No — Yes 1 0/
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
ON
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos (cont'd)
Test
Data Requirement ' Substance
Use
Patterns
Time frame
Does EPA Bibliographic Must Additional for
Have Data?1/ Citation2/ Data Be Submitted? Submissions/
§158.190 Product Chemistry
Physical and Chemical Characteristics (cont
63-7
63-8
63-9
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1 -
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- PH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements
Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A
'd)
All
All
All
All
All
All
All
All
All
All
All
No
I/
V
No
No
No
No
No
No
No
No
YesJ_0/ 6 Months
J/ Yes 6 Months
J_/ Yes 6 Months
YesUy/H/ 6 Month
YesJK)/,J_2/ 6 Month
YesJ_0/,j_3/ 6 Months
Yes10/,14/ 6 Months
YesJHD/ 15 Months
Yes 1 0/ , 1 5/ 6 Months
YesJJV 6 Months
YesjH)/ 15 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use (cont'd)
§158.190 Product Chemistry Footnotes
\J Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ These data citations pertain to the terbufos manufacturing-use product currently registered under EPA Registration
No. 241-241 and may not be applicable to manufacturing-use products which differ from that described herein.
_3/ Due dates refer to the number of months following the issuance of this Registration Standard, unless otherwise
indicated.
_4/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number,
and purpose of the active ingredient and each intentionally added inert must be provided. For the active
ingredient, the following must also be provided: the product name, trade name, and common name; the -—
molecular, structural, and empirical formulas; the molecular weight or weight range; and any experimental f—
or internally assigned company code numbers.
S/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be providedj>.,jalong with
information regarding the properties of each beginning material used to manufacture each product.
6/ A detailed discussion of all toxicologically significant impurities and all impurities that are or may be present
at 2. 0.1%, based on knowledge of the beginning materials, chemical reactions (intended and side) in the manufac-
turing process, and any contamination during and after production must be submitted.
TJ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at _>. 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must
be provided, certified, and validated by sample analysis using analytical procedures for which accuracy and
precision data have been provided. Limits for impurities not associated with the active ingredient need be
provided only if they are considered to be of toxicological significance, regardless of the concentration at
which they are present. Certifications must be submitted on EPA Form 8570, Rev. 2-85.
9/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be
accompanied by validation studies indicating its accuracy and precision. These methods must be suitable
for enforcement of certified limits.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use (cont'd)
§158.190 Product Chemistry Footnotes (cont'd)
10/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing
action, flammability, explodability, storage stability, viscosity, miscibilty, and corrosion characteristics)
as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D
must be submitted.
11/ Required if the test substance is dispersible with water.
12/ Required if the product contains an oxidizing or reducing agent.
13/ Required if the product contains combustible liquids.
14/ Required if the product is potentially explosive.
IS/ Required if the product is a liquid.
OsJ
-------
Data Requirement
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos
Timeframe
Test Does EPA Bibliographic Must Additional for
Substance Have Data? Citation2/ Data Be Submitted? Submission 1/
§158.340 Toxicology
Acute Testing;
81-1 - Acute Oral - Rat
MP
Yes
00037467,00037471
No
K)
81-2
81-3
81-4
81-5
81-6
- Acute Dermal
- Acute Inhalation -
Rat
- Primary Eye Irritation -
Rabbit
- Primary Dermal Irritation
- Dermal Sensitization
MP
MP
MP
MP
MP
Yes 00144805
Yes 0001448063/
No
No
No
No
No
No4/
Nq4/
No4/
„*
•N-
_!/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
indicated.
2/ These data citations pertain to the manufacturing-use (MP) currently registered under EPA Registration
No. 241-241, and may not be applicable to MPs which differ from that described herein.
3/ A 21-day repeated inhalation study fulfills the acute requirements.
4/ ThesB data are not required because mortality would occur before sensitization or irritation.
-------
-------
II. LABELING APPENDICES
74
-------
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
test. 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.lO(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-
ment 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,
75
-------
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size 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 HOBD^- .The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40CFR 162.10(h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON. [40 CFR 162.10(h)(1)(i)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
[40 CFR 162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
76
-------
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)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to '
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel precautionary
statements section, preceded by the heading "Physical/Chemical
Hazards." Note that no signal word is used in conjunction with
the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use) ; or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label (s)
submitted to the Agency as part of your application must reflect
this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
77
-------
Agency's review of your application, your proposed classification
determination will be evaluated in accordance with the provisions
of 40 CFR 162.11(c). You will be notified of the Agency's
classification decision.
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) (1) (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
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
78
-------
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.
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 sue or to supervise the use of the
pesticide. When followed, directions must be adequate to protect
the public from fraud and from personal injury and to prevent
unreasonable adverse effects on the environment. [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.
79
-------
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ffVCAtmONAAV (TATtMCMTt
HAIAMMTOMUMANt
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STORAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
(reason for claanlfylnpj
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-------
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 Keg. No.
EPA Est. Nq.
Ingredients
statement
Pounds/ga 1 Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
ot 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 tront
panel
Bottom front
panel or end
of label text
Bottom tront
panel or end
of label text
Front panel
Front panel,
immediately
bet ore or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
" i
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
It 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 oxitainei instead ot
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preterably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
1 8
8A
UB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement ot
Practical
Treatment or
First Aid
Referral
statement
i
Side/back panel
precaut ionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF RETIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
1, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, 11, 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
I
r*-
oc
Must be grouped under the headings in
BA, 8B, and 8C; preferably blocked.
Must be preceded by apptopriate signal
word.
Environmental hazards include hue
caution where applicable.
-------
SUMMAKY-8
ITEM
8C
9B
1QA
1UB
, 1UC
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 UN LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading ot
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
tor use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix 11 guide
PHYS/CHEM
Includes a statement ot the terms ot
restriction. The words '"RESTRICTED USE
PESTICIDE* must be same type size as
signal word.
Required statement is:
"It is a violation ot Federal law
to use this product in a mannei
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable trom Irom other directions
tor use.
Refer to Appendix 11 guides STOR,
CONT/D1S, and PEST/DIS tor tutther
information and required statements.
May be in metric as well as U.S. units
-------
40 CFR Ch. I (7-1-87 Edition)
Environmental Protection Agency
§162.10
00
cn
§ 162.10 Labeling requirement*.
(a) General—(1) Contents of the
label. Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
(I) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
lion:
(ID The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(iii) The net contents as prescribed
m paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section:
-------
00
o\
S 162.10
purposes other than as a pesticide or
drxicr.
in i A false or misleading comparison
xuih oiher pesticides or devices:
Any statement directly or indi-
rrrtly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(4>.
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant Is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by * * V or "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-
pers or other materials and shall be
the average content unless explicitly
slated as a minimum quantity.
(2) If the pesticide is a liquid. Ihe
net content statement shall be in
terms of liquid measure at 68' F (20'C)
and shall be expressed In conventional
American unlls of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, 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, i.e.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
lent or around an average Is permissi-
ble only to the extent that It repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
Environmental Protection Agency
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
sel In type of a size and style similar lo
other print on lhat part of the label
on which it appears and shall run par-
allel lo il. The registration number
and Ihe required identifying phrase
shall nol appear In such a manner as
lo suggesl or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the rjhrase "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 Ihe
package If Ihe EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I) Gener-
al. The label of each pesticide product
must bear a statemenl which contains
the name and percentage by weight of
each active Ingredient, Ihe total per-
centage by welghl of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic In any form, a statemenl of Ihe
perccnlages 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 Ihe
lerm "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same lype size, be aligned lo Ihe same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
nol required for pesticides which con-
lain 100 percent aciive Ingredients.
Unless Ihe Ingredient stalement Is a
complete analysis of Ihe pesticide. Ihe
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement.
(I) The Ingredient stalement 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 must
also appear on such oulsidc conlainer
§162.10
or wrapper. If Ihe size or form of the
package makes it impracticable to
place the Ingredient slatement on the
front panel of the label, permission
may be granted for the Ingredient
statemenl lo appear elsewhere.
(II) The lexl of the Ingredient state-
menl musl run parallel wilh other
text on the panel on which it appears.
and must be clearly distinguishable
from and musl nol be placed in the
body of olher 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 may be used alone only
if it is well known. If no common name
has been established. Ihe chemical
name alone shall be used. In no case
will Ihe use of a Irademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administralor under Ihe
authority of seclion 25(c)(6).
(4) Statements of percentages. The
percenlages of ingredients shall be
stated in lerms 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 values such as "22-25%." If
Ihe uses of Ihe pesliclde producl are
expressed as weight of active ingredi-
ent per unit area, a stalemenl of the
weight of active ingredienl per unit
volume of Ihe peslicide formulation
shall also appear in Ihe ingredient
stalemenl.
(5) Accuracy o/ stated percentages.
The percenlages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If Ihere may be un-
avoidable variation belween manufac-
turing batches, the value staled for
each active Ingredienl shall be the
lowest percenlage which may be
presenl.
(6) Deterioration. Pesllcides which
change In chemical composilion sig-
nlflcanlly musl meel Ihe following la-
beling requirements:
(I) In cases where II is determined
that a pesticide formulation changes
chemical composition significantly.
Ihe product must bear Ihe following
stalement in a prominent position on
-------
(he label: "Not for sale or use after
(dale)."
di) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such mgredienUs) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hatard indicators
Oral ID-
inhalation LC_
Dermal L0_
Eye elf eels
b».ll ullucl>
Tokioty categories
1
Up 10 and including SO
Up 10 and including 2
trig/Met
Up 10 and including 200
mg/kg
Corrosive, cornea!
opacity nol reversible
within 7 days
Corrosive
II
From SO thru SOO mg/kg
From 2 thru 2 mg/kler
From 200 thru 2000
Corneal opacity
reversible wilhm 7
days, irritation
persisting lor 1 days
Severe irritation ai 72
hours
III
From SOO thru 5000 mg/
k«
Fiom 2 thru 20 mg/kter
From J 000 Inru 20.000
No corneal opacity.
ifntation reversible
wiirwi 7 days
Mouoialu irritation at 12
hours
IV
Greater than SOOO mg/
k8
Greater man 20 mg/htef
Creator than 20 000
No rnlalion
Mild or slight irnldlion al
72 hours
(i) Human hazard signal word—(A)
Toncity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
<-D ditlon if the product was assigned to
-•vj Toxicity Category I on the basis of its
oral, inhalation or dermal toxlcity (as
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. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall 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
that such labeling Is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(II) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only In 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 the nature of the pesticide Is such
that It is approved for use on Infants
or small children, may the Administra-
tor waive this requirement.
(iii) Statement of practical treat-
ment—{At Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icily. The Agency may, however,
permit reasonable variations In the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment Is nol
required on the front panel excepl as
described In paragraph (hXlHlllHA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment al tils option. Statements of
practical trealmenl are, however, re-
quired elsewhere on Ihe label in
accord with paragraph (h)(2) of Ihis
seclion if ihey do nol appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
menu shall be grouped logether on
the label, and shall appear with suffi-
cient prominence relative lo other
front panel lexl and graphic material
lo make them unlikely lo be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Sue oc label ironi panel n square
metes
S and under
Above 5 lo 10
Above 10 to IS
Above IS 10 30
Over 30
Points
Required
signal
wort, all
capitals
6
10
12
14
ia
Keep oul
of reach ol
Children'
6
6
e
10
12
(2) Other required warnings arid pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(I) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be immediately pre-
ceded b'y 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.
ToiiCily
category
Precautionary tuiementt by loudly category
Oral, inhalation. Of dermal louctly
Faui (poisonous) << swallowed Inhaled a absorbed
through Hun] Do not wealne vapor Idutl or spray
(null Oo not gel "* •>•* on skin, of on dolhng
IFfonl panel statement ol piKUcal treatment re-
quired I
May be latai J swallowed (whaled or absorbed
through ine skin) Oo not breathe vapors (dust of
I spray mil) Oo nol gel •< eyes, on skm. of on
doming (Appropriate toil ad »lelemenls required I
HarmM i swallowed Inhaled of absorbed through ine
skin) Avod breamng vapors Idusl of spfay nnsl)
Avoid contact «nlh skin (eyes Of clollwigl (Appro-
priate Itfsl aid statement recjuved I
(No precaubona/y statements recjuMed I
Skm and eye local eilecis
Cofioswe. causes eye and skin damagti lor ik.n
tfniaiion} Oo not gel m eyes, on skm. or on
clothing Wear goggles or lace shield and rubber
gloves when handling Hannlul or laul ii swallowed
(Appfopnaie lifsl aid statement requtfed 1
Causes eye land slun) irritation Oo nol get in eyes
on skin. Of on clolhmg Hafmlul il swallowed [Ap
prooriaie lifsl aid statement required 1
AVON] contact with skm. eyes Of clothing In case ol
contact vnmedialely llush eyes or skm with plenty ol
watef Gel medial attention il Mutation persists
[No precautionary statements required ]
(II) Environmental hazards. Where a
•hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements arc re-
quired slating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
-------
CO
CD
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC>. of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active ingredient
with an avian acute oral LD» of 100
me/kg or less, or a subacute dietary
LC,. of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(£) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(lit) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash point
Reouued le»
(A) PRCSSURUEO CONTAINERS
Rain poml at or below 20* F
any valve opening
il there is a flashback at
* tavti point abo>e 20 f ano noi ovtn bO* F or it the
llama ualwnnon is moie man tb m long at a distance
ol 6 in liom the llame
Ail olnur uressuniod conlameis
Extremely flammable Conlanls under pressure Keep away from
lira sparks and heated surfaces Do not puncture or incinerate
container Exposure to temperatures above 130* F may cause
txjr sling
FiamrnaDbe Contents under pressure Keep away Irom heal.
spa'ks anj open llame Do not puncture or incinerate container
Exposure to temperatures above 130* F may cause bursting
Contents under pressure Oo not use or store near heal or open
llame Do not puncture or incinerate container Exposure to
temperatures above 130* F may cause bursting
(B) NONpRESSuRizeo CONTAINERS
At 01 below 20' F
Above 20' F and not over BO* F
Above 80' F and not over ISO1 f
Extremely flammable Keep away I'ont lire sparks and healed
surlaces
Flammable Keep away Irom heal and open Dame
Oo not use Of store near heal or open llame
(i) Directions for Use—(I) General
requirements—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the 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 graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections In the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(Ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
U> The label clearly shows that the
product is Intended for use only in
manufacturing processes and specifies
the typeis) of products involved.
12) 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
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
(J) The label clearly states that the
product Is for use only by physicians
or veterinarians;
( The label clearly stales that the
product Is intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the lype(s) of pesticide prod-
ucts Involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack
aged is registered; and
(4) The Administrator determine*
that such directions are not necessary
to prevent unreasonable adverse ef
feels on man or the environment.
(2) Contents of Directions for Use
The directions for use shall includi
the following, under the headings • Di
rectlons for Use":
(I) The slatement of use classifica
tion as prescribed In 162.10(j) immedi
ately under the heading "Direction.1
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
slstent with Its labeling."
(Ill) The slte(s) of application, as foi
example the crops, animals, areas, 01
objects to be treated.
(Iv) The target pest(s) associates
with each site.
(v) The dosage rate associated wit)
each site and pest.
(vl) The method of application, in
eluding instructions for dilution, if rr
quired, and type(s) of application ap
paratus or equipment required.
(vii) The frequency and timing of ap
plications necessary to obtain effectivi
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on recntr
to areas where the pesticide has beei
applied, meeting the requirement
concerning reentry provided by
-------
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who 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 be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(P) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) 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 different
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(j>(2).
(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 uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in § 162.10(h)UXiv)). and appear-
ing 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
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 PR 28268. July 3. 1975: 40 PR 32329,
Aug. I. 1975: 40 PR 36571. Aug. 21. 1975, as
amended at 43 PR 5786. Feb. 9, 1978]
89
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PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame.
Do not use or store near
heat and open flame.
None required.
90
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STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,.
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
91
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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 |Do not reuse container (bottle, can, jar).
I(bottles, cans. Jars)I Rinse thoroughly before discarding in trash.
|Non-aerosol products
I fbacrs)
Do not reuse bag. Discard bag in trash.
[Aerosol products
|Replace cap and discard containers in
I trash. Do not incinerate or puncture.
2.
All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
|Triple rinse (or equivalent). Then offer |
.Ifor recycling or reconditioning, or puncture)
jand dispose of in a sanitary landfill, or by|
j other procedures approved by state and local\
I authorities.
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
1 cylinders
V Manufacturer may
(Triple rinse (or equivalent). Then offer |
(for recycling or reconditioning, or puncture)
. jand dispose of in a sanitary landfill, or .
(incineration, or, if allowed by state and
| local authorities, by burning. If burned,
(s^ay out of smoke «_
(Triple rinse (or equivalent). Then dispose
| of in a sanitary landfill or by other
(jrpproved 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
1 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. If burned, stay
lout of smoke.
(Return empty cylinder for reuse (or
(similar wordina) .
replace this phrase with one indicating whether
and how fiber drum may be reused.
92
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PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:;
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, 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 or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or 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."
93
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III. BIBLIOGRAPHY APPENDICES
94
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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 explanation. In a few cases, entries added
to the bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is also to be
used whenever specific reference 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.
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
95
-------
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 following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship 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.
96
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00029863 Consultox Laboratories (1975) Acute Oral and Percutaneous
Toxicity Evaluations. (Unpublished study received Feb 3,
1976 under 2749-425; submitted by Aceto Chemical Co.,
Inc., Flushing, N. Y. ; CDL: 241 780-A)
00032636 Fischer, J.E. (1979) Toxicity Data Report: Report No. A79-109.
(Unpublished study received Jun 11, 1980 under 241-260;
submitted by American Cyanamid Co., Princeton, N. J. ;
CDL:099451-B)
00032646 Palochak, M.E. ,• Shapiro, R. L. (1971) Microbiology Laboratory
Report: Report No. 710903M1. (Unpublished study received
Jan 19, 1971 under 52-127; prepared in cooperation with
Hudson Laboratories, Inc., submitted by West Chemical
Products, Inc., Lynbrook, N. Y. ; CDL: 000053-A)
00035120 Krize, J.W.-; Terrel Y. (1978) Report: Avian Dietary LC50
(5-Day Dietary Exposure) of Enlist Technical (Terbufos
Technical) EPA File Symbol 2749-UEL to Mallard Duck;
Laboratory No. 8E-3451. (Unpublished study received
Mar 27, 1979 under 2749-425; prepared by Cannon Labora-
tories, Inc., submitted by Aceto Chemical Co., Inc.,
Flushing, N.Y.; CDL:241730-A)
00035121 Parke, G. S. E. ; Terrell, Y. (1976) Acute Oral Toxicity in
Rats: Compound: Enlist Technical Insecticide (Terbufos)
EPA File Symbol 2749-UEL: Laboratory No. 6E-3164.
(Unpublished study received Nov 29, 1976 under 2749-425;
prepared by Cannon Laboratories, Inc., submitted by
Aceto Chemical Co., Inc., Flushing, N.Y.; CDL:241733-A)
00036123 Caballa, S.H.; Ku, C.; Miller, P.; et al. (1975) Summary—
Metabolism of Counter (CL 92,100) in Sugar Beets. (Unpub-
lished study including project no. 2-404 and report
nos. C-698 and M-606, received Jun 10, 1975 under 5F1640;
submitted by America Cyanamid Co., Princeton, N.J.;
CDL:094445-G)
00036124 Higham, J.W.; Alvarez, C.G. ; Burhardt, C.C.; et al. (1975)
General Summary: Counter™(R) 15G Soil Insecticide Residues
in Sugar Beet Tops and Roots. (Unpublished study received
Jun 10, 1975 under 5F1640; submitted by American Cyanamid
Co., Princeton, N. J. ; CDL:094445-H)
97
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00036127 Higham, J.W. ; Peterson, R. P. (1974) CL 92,100 and 92,100
Related Compounds: Gas Chromatographic Procedure for the
Determination of CL 92,100 in Sugar Beet Tops (Greens)
and Roots. Includes method M-395 dated Mar 1, 1973.
(Unpublished study including report no. C-532, received
Jun 10, 1975 under 5F1640; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094445-K)
00036129 Peterson, R. P. ; McGinnis, R. A. (1975) Counter (CL 92,100):
Total Counter-Related Residues in Sugar Beet Dried Pulp
and Juice (Thick and Thin): Report No. C-679. Includes
method no. M-501 dated May 1, 1975. (Unpublished study
received Jun 10, 1975 under 5F1640; prepared in cooperation
with Spreckels Sugar co., submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094445-M.
00036241 Manuel, A. J. (1972) Total CL 92,100 and Its Metabolites in
Milk: Report No. C-336. Includes method M-353 dated Jul 31,
1972. (Unpublished study received Apr 9, 1973 under 3G1340;
submitted by American Cyanamid Co., Princeton, N. J;
CDL: 093581-J)
00036242 Manuel, A.J. ; Peterson, R.P.; Potts, C.R.; et al. (1972)
CL 92,100 and Its Metabolites in Cattle Fat, Muscle,
Liver and Kidney: Report No. C-337. Includes method
M-372 dated Nov 9, 1972. (Unpublished study received
Apr 9, 1973 under 3G1340; submitted by American Cyanamid
Co., Princeton, N. J.; CDL:093581-K)
00036246 American Cyanamid Company (1972) CL-92100: Determination of
Total CL-92100-Related Residues in Corn Forage and Grain.
Method M336 dated Jun 21, 1972. (Unpublished study received
Apr 9, 1973 under 3G1340; CDL: 093582-C)
00037467 American Cyanamid Company (1972) Toxicity Data: O, O-Diethyl-S
(tert-butylthiomethyl) phosphorodithioate Technical, 85.8%
AC 2162-42: Report A-72-95. (Unpublished study received
Apr 9, 1973 under 3G1340; CDL: 093584-B)
00037469 Sabol, R. J. ; Smith, J.M. ; Wilson, N. H. ; et al. (1972) A 3
and 24 Month Oral Toxicity and Carcinogenicity Study of
AC 92, 100 in Rats: Three Month Report: Project No.
71R-725. (Unpublished study received Apr 9, 1973 under
3G1340; prepared by Bio/dynamics, Inc., submitted by
American Cyanamid Co., Princeton, N. J. ; CDL: 093584-D)
93
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00037471 Kretchmar, B. (1972) Report to American Cyanamid: Acute
Oral Toxicity Studies with Two Samples in Female Albino
Rats: IBT No. A1373. (Unpublished study received Apr
9, 11973 under 3G1340; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by American Cyanamid
Co., Princeton, N. J. ; CDL:093584-G)
00037472 Smith, J.H. ; Rosselet, C.; Cannelongo, B.; et al. (1972) A
Neurotoxicity Study of AC 92,100, an Organic Phosphate
Cholinesterase Inhibitor, in Hens: Project No. 72S-788.
(Unpublished study received Apr 9, 1973 under 3G1340;
prepared by Bio/dynamics, Inc. submitted by American
Cyanamid Co., Princeton, N. J. ; CDL: 093584-H)
00037473 Smith, J.M.; Kasner, J. (1972) Status Report for American
Cyanamid Company, November 28, 1972: A Three Generation
Reproduction Study of AC 92,100 in Rats: Project No.
71R-727. (Unpublished study received Apr 9, 1973 under
3G1340; prepared by Bio/dynamics, Inc., submitted by
American Cyanamid Co., Princeton, N. J.; CDL: 093584-1)
00037483 Sleight, B.H., III (1972) The Acute Toxicity of Cycocel™(R) .
and Experimental Insecticide AC 92,100 to Bluegill
(Lepomis maclished study received Apr 9, 1973 under
3G1340; prepared by Bionomics, Inc., submitted by
American Cyanamid Co., Princeton, N. J. ; CDL: 093584-U)
00039018 American Cyanamid Company (1974) General Summary: Counter
Related Residues in Immature Corn Commodities from In-
Furrow Application of Counter™(R) 15G Soil Insecticide
at Planting. Summary of studies 094895-D through
094895-G. (Unpublished study received 1976 under 6F1657;
CDL:094895-C)
99
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00042017 American Cyanamid Company (1973) Summary—Counter-Related
Residues in Corn. (Unpublished study received May 1,
1974 under 4F1496; CDL:091452-A)
00042019 Higham, J.W. ,- Manuel, A. J.; Peterson, R. P. ; et al. (1974)
Efficacy of Counter and Other Herbicides on Corn:
Report No. C-415. Includes method M-336 dated Jun
21, 1972. (Unpublished study including report nos.
C-416 and C-425, received May 1, 1974 under 4F1496;
prepared in cooperation with Quality Control Laboratories
and others, submitted by American Cyanamid Co., Princeton,
N. J. ; CDL: 091452-C)
00042020 Higham, J.W. ; Manuel, A.J.; Congleton, W.F. ; et al. (1974)
Counter™(R) 15G: Total Counter (CL 92,100)-Related
Residues in Soybean Commodities: Immature Plant,
Harvest "Plant and Harvest Beans (Kansas and Iowa):
Report No. C-429. Includes method M-480 dated Jan 9,
1974. (Unpublished study received May 1, dustries and
Iowa State Univ., Dept. of Zoology & Entomology, submitted
by American Cyanamid Co., Princeton, N. J.; CDL: 091452-D)
00042021 Manuel, A. J. ; Elenewski, C. A. (1974) Counter (CL 92,100)
Stability of Residues in Counter-Treated Corn Grain
and Forage Samples When Stored in the Frozen State:
Report No. C-430. Includes method M-336 dated Jun 21,
1972. (Unpublished study received May 1, 1974 under
4F1496; submitted by American Cyanamid Co., Princeton,
N. J. ; CDL: 091452-F)
00042022 . Manuel, A.J. (1973) Counter (CL 92,100): Confirmatory Gas-
Liquid Chromatography Test for Counter Residues in
Corn Grain and Forage, and in Animal Tissues: Report
No. C-379. Includes method M-460 dated Sep 27, 1973.
(Unpublished study received May 1, 1974 under 4F1490;
submitted by American Cyanamid Co., Princeton, N. J. ;
CDL:091452-G)
too
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OFFICE OF PESTISCIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00045378 Smith, J.M.; Kasner, J.A. (1973) Status Report for American
Cyanamid—March 9, 1973; A Three and Twenty-Four Month
Oral Toxicity and Carcinogenicity Study of AC 92,100 in
Rats—11 Month Status of Eye Observations: Project No.
71R-725. (Unpublished study received Apr 9, 1973 under
3G1340; prepared by Bio/dynamics, Inc., submitted by
American Cyanamid Co., Princeton, N. J.; CDL: 093580-A)
00045379 Smith, J.M. ; Willigan, D. A. (1973) A Neurotoxicity Study of
AC 92,100, an Organic Phosphate Cholinesterase Inhibitor
in Hens: Project No. 72S-788. (Addendum I; unpublished
study received Apr 9, 1973 under 3G1340; prepared by
Bio/dynamics, Inc., submitted by American Cyanamid Co.,
Princeton, N. J. ; CDL: 093580-B)
00049235 Snyder, E. H. '(1975) Counterm(R) (CL 92,100): The Gas Chromato-
graphic Determination of CL 92, 100 (0,0-Diethyl) SButyl-
thiomethyl-phosphorodithioate)-Related Residue in Fortified
Barley, Green Beans, Red Beets and Wheat: Report No. C-730.
(Unpublished study received Oct 9, 1975 under 241-238; sub-
mitted by American Cyanamid Co., Princeton, N. J.;
CDL: 224099-C)
00049236 Rapp, W.R.; Wilson, N. H. ; Mannion, M.; et al. (1974) A Three
and Twenty-Four Month Oral Toxicity and Carcinogenicity
Study of AC 92,100 in Rats: Project No. 71R-725. (Unpub-
lished study received May 29, 1975 under 241-238; prepared
by Bi©dynamics, Inc., submitted by American Cyanamid Co.,
Princeton, N. J. ; CDL: 224096-A)
00062871 Peterson, R. P. (1976) Counter™^) Insecticide 15-G and Liquid
(CL 92,100): Metabolism of "14C-Labeled CL 92,100 ... in
Cabbage Plants: PD-M 13-1:1-19. (Unpublished study received
Nov 3, 1980 under 241-238; submitted by American Cyanamid
Co., Princeton, N.J. ; CDL:099682-A)
101
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00062872 American Cyanamid Company (1976) Residue Studies in Cabbage,
Broccoli and Cauliflower. (Compilation; unpublished
study received Nov 3, 1980 under 241-238; CDL:099682-B)
00063209 Allen, J.S.; Johnson, E.; Wainwright, C. (1977) Mutagenicity
Testing of Technical Counter™(R) Soil Insecticide (Terbufos)
in the Ames Test: AIR 5:419-431. Final rept. (Unpublished
study received Apr 17, 1978 under 241-241; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:234103-B)
00066220 Atkins, E.L., Jr.; Anderson, L.D.; Kellum, D.; et al. (1976)
Protecting Honey Bees from Pesticides. ?: Univ. of Cali-
fornia, Div. of Agricultural Sciences. (Leaflet 2883;
also In unpublished submission received Mar 20, 1980
under 432-502; submitted by Penick Corp., Lyndhurst,
N.J.; CDL:243536-B)
00069512 North, H.H.; Barringer, D.F.; Gatterdam, P.E.; et al. (1972)
CL 92,100 Insecticide: Fate of C™14-Labeled CL 92,100 in
Sweet Corn Plants: PDM 9:249-301. (Unpublished study
received on unknown date under 241-EX-59; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:223458-X)
00079429 Chiu, T.Y.; Lucas, L.M. (1981) Counter™^) Terbufos
(CL 92,100): 18-16:1-43. (Unpublished study received Jul
13, 1981 under 241-238; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:070186-A)
00079430 American Cyanamid Company (1980) Residue Studies with Counter(R)
15-G Soil Insecticide-Nematicide in Sorghum. (Compilation;
unpublished study received Jul 13, 1981 under 241-238;
CDL:070186-B)
00079431 Peterson, R.P.; Good, T. (1979) Counter™(R) Terbufos
(CL 92,100): Validation of GC Method M-0995 for the
Determination of Total CL 92,100-Related Residues in
Sorghum Tissues (Silage, Fodder and Grain): Report No.
C-1592. Includes method M-995 dated Jul 11, 1979.
(Unpublished study received Jul 13, 1981 under 241238;
submitted by American Cyanamid Co., Princeton, N.J.;
CDL: 070186-C)
102
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00085169 Kruger, R. ,- Feinman, H. ; (1973) 30-day Subacute Dermal
Toxicity in Rabbits of AC-92100: Laboratory No. 1611.
(Unpublished study received May 1, 1974 under 4F1496;
prepared by Food and Drug Research Laboratories, Inc.,
submitted by American Cyanamid Co., Princeton, N. J. ;
CDL:090808-J)
00085172 Smith, J.M.; Kasner, J.A. ; Wilson, N.H. ; et al. (1972) A
Three Generation Reproduction Study of Pesticide
AC 92,100 in Rats: Project No. 71R-727. (Unpublished
study received May 1, 1974 under 4F1496; prepared by
Bio/dynamics, Inc., submitted by American Cyanamid Co.,
Princeton, N. J. ; CDL: 090808-M)
00085176 Bentley, R.E. (1973) Acute Toxicity of Counter™(TM) to Blue-
gill (Lepomis macrochirus), Channel Catfish (Ictalurus
punctatusO and Crayfish (Procambarus clarkii). (Unpub-
lished study received May 1, 1974 under 4F1496; prepared
by Bionomics, Inc., submitted by American Cyanamid Co.,
Princeton, N. J. ; CDL:090808-Q)
00085178 . Labisky, R.F.; Anderson, W.L. (1973) Effects of Field Appli-
cations of Counter™(R) Soil Insecticide on Wildlife.
(Unpublished study received May 1, 1974 under 4F1496;
prepared by Illinois Natural History Survey, submitted
by American Cyanamid Co., Princeton, N. J. ; CDL:090808-T)
103
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00085179 Labisky, R.F. (1974) Responses of Confined Hen Pheasants
to Simulated Field Applications of Counter™(R) Soil
Insecticide. (Unpublished study received May 1, 1974
under 4F1496; prepared by Illinois Natural History
Survey, submitted by American Cyanamid Co., Princeton,
N. J. ; CDL-.090808-U)
00085180 Manuel, A.J. (1973) Counter"(TM) 15G Soil Insecticide;
CL 92,100 and Its Metabolites in Wildlife Tissues and
Eggs: Report No. C377. (Unpublished study received
May 1, 1974 under 4F1496; submitted by American Cyanamid
Co., Princeton, N. J. ; CDL: 090808-V)
00085183 Manuel, A.J. (1973) Counter™(TM) (CL 92,100) Related Residues
in Pheasant Muscle, Liver, Skin, Kidney and Fat: Report
No. C378. (Unpublished study received May 1, 1974
under 4FM496; submitted by American Cyanamid Co., Princeton,
N. J. ; CDL: 09 08 08-Y)
00087686 Higham, J.W.; North, H.H. (1974) Counter™(R) 15G: CL 99875
(Metabolite 13) Residue in Corn Silage and Fodder:
Report No. C-437. (Unpublished study received May 1,
1974 under 4F1496; submitted by American Cyanamid Co.,
Princeton, N. J. ; CDL: 091 409-C )
00087687 Higham, J.W. (1974) CL 99, 875: The Determination of CL 99,875
in Corn Silage and Fodder. Method M-489 dated Feb 19,
1974. (Unpublished study received May 1, 1974 under
4F1496; submitted by American Cyanamid Co., Princeton,
N. J. ; CDL:091409-D)
00087688 North, H.H.; Jenney, K. (1974) Counter"(R) Soil Insecticide:
Residue Levels and Metabolism in Sweet Corn Foliage
and Grain: Report No. 442. (Unpublished study received
May 1, 1974 under 4F1496; submitted by American Cyanamid
Co., Princeton, N. J. ; CDL: 091 409-E)
00087689 Barringer, D.F. ; Gatterdam, P.; Steller, W.A. (1973)
CL 92,100 Counter™(R) Insecticide: The Identification
of the Major Metabolites Found in Mature Sweet Corn
Plants and in Soil: PD-M 10: 423-454. Progress rept.,
Jun 27, 1972 through Mar 30, 1973. (Unpublished study
received May 1, 1974 under 4F1496; submitted by American
Cyanamid Co., Princeton, N. J. ; CDL: 091409-F)
104
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00087691 Caballa, S. ; Ku, C. ; Miller, P. (1973) Counter"^) Insecti-
cide (15-G): Metabolism of W14C-Labeled CL 92,100 in
Sugar Beets: Report No. C-405. (Unpublished study
received May 1, 1974 under 4F1496; submitted by American
Cyanamid Co., Princeton, N. J. ; CDL: 091 409-H)
00087692 Gatterdam, P.; Jenney, K. (1974) Counterm(R) Soil Insecticide:
Residue Levels in Soybeans Grown as a Follow Crop on Soil
Previously Treated with W1 4C-CL 92,100: Report No. C-422.
(Unpublished study received May 1, 1974 under 4F1496;
submitted by American Cyanamid Co., Princeton, N.J.;
CDL;091409-1)
00087694 Metabolic Studies of ™14C-labeled CL 92,100 in Hydrolytic
and Photolytic Environments: PD-M 10:959-1007. Progress
rept., Apr 5, 1973 through Oct 15, 1973. (Unpublished
study received May 1, 1974 under 4F1496; submitted by
American Cyanamid Co., Princeton, N.J. ; CDL:091409-K)
00087695 North, H.H. (1973) Counter™(R) Insecticide: Rat Metabolism
of CL 92, 100 PD-M 10:1008-1080. Progress rept., Mar
1, 1973 -through Sep 28, 1973. (Unpublished study recieved
May 1, 1974 under 4F1496; submitted by.American Cyanamid
Co., Princeton, N. J. ; CDL: 091409-L)
00087702 Manuel, A.J. (1973) CL 92,100 and Its Metabolites in Chicken
Fat, Muscle, Liver, Kidney, Skin, and Eggs: Report No.
C-372. (Unpublished study received May 1, 1974 under
4F1496; submitted by American Cyanamid Co., Princeton,
N. J. ; CDL: 091 837-B)
00087704 American Cyanamid Company (1973) CL 92,100: Determination
of Total CL 92,100 and Oxidative Metabolites in Chicken
Fat, Muscle, Skin, Liver, and Kidney by Gas Liquid
Chromatography. Method M-401 dated Mar 15, 1973.
(Unpublished study received May 1, 1974 under 4F1496;
CDL: 091837-D)
00087717 Roberts, S. ; Wineholt, R. L. (1976) 81-day Dietary LC50 Study
of Terbufos in Bobwhite Quail and Mallard Duck: Laboratory
No. 6E3165. (Unpublished study received Nov 24, 1976
under 2749-427; prepared by Cannon Laboratories, Inc.,
submitted by Aceto Chemical Co., Inc., Flushing, N.Y.;
CDL:226950-A)
00087718 Roberts, S.; Wineholt, R.L. (1976) Static 96-hour Toxicity
Study of Terbufos in Bluegill Sunfish and Brown Trout:
Laboratory No. 6E-3166. (Unpublished study received
Nov 24, 1976 under 2749-427; prepared by Cannon Labora-
tories, Inc., submitted by Aceto Chemical Co., Inc.,
Flushing, N. Y. ; CDL: 226951 -A)
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00087722 American Cyanamid Company (1972) Residue of AC 92,100 in
Corn. Includes method M-336 dated Jun 21, 1972. (Com-
pilation; unpublished study, including report nos.
C-335, 72-43, 82-47, received on unknown date under
241-EX-3; CDL:123080-E)
00087724 American Cyanamid Company (1975) [Residues of Counter(R)
15G in Corn and Popcorn], Includes method M-336 dated
Jun 21, 1972. (Compilation; unpublished study, including
report Nos. C-644, C-635, C-639 ..., received Apr 1,
1975 under 241-238; CDL:110506-B)
00087726 Wang, G.T. (1973) Letter sent to Harold H. Nau dated Jun
21, 1973: Post-mortem examination—wildlife. (Unpublished
study received on unknown date under unknown admin.
no.; submitted by American Cyanamid Co., Princeton,
N.J.; CDt:223457-A)
00088210 Chiu, T.; Lucas, L.; Goldenbaum, L. (1981) Counter"1^)
Terbufos (CL 92,100): Metabolism of Carbon-14 Labeled
CL 92,100 in Soybean: Report No. PD-M 18-19:1-65.
(Unpublished study received Dec 1, 1981 under 241-238;
submitted by American Cyanamid Co., Princeton, N.J.;
CDL:070496-A)
00088211 American Cyanamic Company (1981) General Summary: Counter
15-G. (Compilation; unpublished study received Dec 1,
1981 under 241238; CDL:070496-B)
00101495 Boudreau, P.; Forbis, A.D.; Franklin, L.; et al. (1982)
Acute Toxicity of Counter® Terbufos to Daphnia magna;
Static Acute Bioassay Report 28686. (Unpublished
study received Apr 20, 1982 under 241-238; submitted
by American Cyanamid Co., Princeton, N.J., CDL:247247-C)
00106551 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1982) Final
Report: Acute Oral LD50 — Bobwhite Quail: Counter®
Terbufos Technical: Project No. 130-133. (Unpublished
study received Apr 20, 1982 under 241-238; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:247247-B)
00109446 Daley, I.; Rinehart, W.; Martin, A. (1979) A Three Month
Feeding Study of Counter® Terbufos Insecticide in Rats:
Project No. 78-2343 (Unpublished study received ? ,
1982 submitted by American Cyanamid Co., Princeton, N.J.;
CDL: 247985-A)
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
0129173
0131237
0131477
0133299
0137582
0137760
0142295
0144805
0144806
0147533
American Cyanamid Company (1980) Metabolism and Residues:
Counter Soil Insecticide-nematicide: Rape and Mustard.
(Compilation; unpublished study received Jul 14, 1983
under 241-272; CDL:071747-C)
Mangels, G.; Goldenbaum, L. (1983) Counter Terbufos (CL 92,100)
Metabolism of Carbon-14 Labeled CL 92,100 in Wheat Grain:
Project No. 0427. (Unpublished study received Oct 3,
1983 under 241-238; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:251414-C)
Labisky, R. (1975) Responses of pheasants to simulated
field applications of counter, an organophosphate
insecticide. Journal of Wildlife Management 39(1):
174-178. (Also in unpublished submission received Oct 6,
1983 under 241-238; submitted by American Cyanamid Co.,
Princeton", NJ; CDL:251469-B)
American Cyanamid Co. (1983) Metabolism and Residues: Counter
Insecticide. (Compilation; unpublished study received
Nov 22, 1983 under 241-238; CDL:072150-A)
American Cyanamid Co. (1984) Metabolism and Residues: Counter
Soil Insecticide-nematicide in Corn Plants, Fodder and
Grain. (Compilation; unpublished study received Feb 9,
1984 under 241-238; CDL:252421-A)
Peterson, R.; Picard, G.; Higham, J.; et al. (1984) Farm
Worker Exposure Study with Aerial Application of Counter
15-G: Report No. C-2370. (Unpublished study received
Mar 21, 1984 under 241-238; submitted by American Cyanamid
Co., Princeton, NJ; CDL:252762-A)
American Cyanamid Co.
Unpublished study.
(1984) [Product Chemistry for Counter],
84 p.
Fischer, J. (1985) Rabbit Dermal LD5Q (Intact Skin): Report
No. A85-54. Unpublished study prepared by American Cyanamid
Co. 3 p.
Rusch, G. (1980) A Two Week Inhalation Toxicity Study of
Technical Counter Terbufos in the Rat: Project No. 78-
7168. Unpublished study prepared by Bio/Dynamics, Inc.
346 p.
Rodwell, D. (1985) A Teratology Study with AC 92, 100 in Rats:
Project No. WIL-35014: Final Report. Unpublished study
prepared by WIL Research Laboratories, Inc. 212 p.
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
0147534 American Cyanamid Co. (1983) Sample Identification, Purity
and Minor Component Profile [Counter Terbufos]. Unpublished
study. 28 p.
00156853 Peterson, R. (1983) Counter Terbufos (CL 92,100): Aerobic
and Anaerobic Metabolism of CL 92,100 in a Silt Loam Soil:
Project No. 0402: Report No. PD-M Volume 20-4. Unpublished
study prepared by American Cyanamid Co. 52 p.
0158614 Elenewski, C. (1983) Counter Terbufos (CL 92,100): Validation
of GC Method M-1340 for the Determination of Total CL 92,100-
related Residues in Whole Bananas: Report No. C-2260.
Unpublished study prepared by American Cyanamid Co. 13 p.
0160387 Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite with
AC 92,100: Final Report: Project No. 130-134. Unpublished
study prepared by Wildlife International Ltd. 18 p.
0161567 Mangels, G. (1986) Counter Insecticide, Terbufos (CL 92,100):
Water Photolysis: Report No. PD-M 23-19: Project No. 0112.
Unpublished study prepared by American Cyanamid Co. 29 p.
00161568 Lee, T.; Belcher, D. (1986) Counter Terbufos (CL 92,100):
Residues of CL 92,100-related Compounds in Soil and Rotational
Crops (Cabbage, Red Beets, and Wheat) from a Treated Corn
Field (Waunakee, WI, 1984) (C-1689, C-0532, C-0880, C-2642):
Report No. C-2658: Project No. 0402. Unpublished study
prepared by American Cyanamid Co. 28 p.
00161569 Lee, T.; Belcher, D. (1986) Counter Terbufos (CL 92,100):
Residues of CL 92,100-related Compounds in Soil and Rotational
Crops (Cabbage, Sugar Beets, and Wheat) from a Treated Corn
Field (York, NE, 1984) (C-1689, C-0532, C-0880, C-2642):
Report No. C-2721: Project No. 0403. Unpublished study
prepared by American Cyanamid Co. 53 p.
00161570 Putman, D. (1986) The Acute in vivo Cytogenetics Assay in Rats:
AC 92,100: Final Report: MA Study No. T4277.105002.
Unpublished study prepared by Microbiological Associates,
Inc. 44 p.
00161571 Mackenzie, K. (1986) Dominant Lethal Study with AC 92,100 in
Rats: Final Report: Study No. 6123-137. Unpublished
American Cyanamid Study No. 980-85-193 prepared by Hazleton
Laboratories America, Inc. 147 p.
108
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
00161572 Shellenberger, T. (1986) One-year Oral Toxicity Study in Purebred
Beagle Dogs with AC 92,100: Final Report: Report No. 8414.
Unpublished America Cyanamid Co. Report No. 981-84-118
prepared by Tegeris Laboratories, Inc. 836 p.
00161573 Beavers, J. (1986) Counter Technical: A One-generation
Reproduction Study with the Bobwhite (Colinus Virginianus
Final Report: Project No. 130-137. Unpublished study
prepared by Wildlife International Ltd. 129 p.
00161574 Beavers, J. (1986) Counter Technical: A One-generation
Reproduction Study with the Mallard (Anas platyrhynchos):
Final Report: Project No. 130-138. Unpublished study
prepared by Wildlife International Ltd. 129 p.
00162525 Forbis, A.; Land, C.; Bunch, B. (1986) Chronic Toxicity of CL
92,100 to'Daphnia magna Under Flow-Through Test Conditions:
ABC Final Rept. #32891. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 164 p.
40089602 Daly, I. (1987) A One-year Dietary Toxicity Study with AC 92,100
in Rats: Chronic Toxicity in Rats:- Project No. 85-2964.
Unpublished study prepared by Bio/dynamics, Inc. 1604 p.
40089603 Shellenberger, T. (1986) Chronic Dietary Toxicity and
Oncogenicity Study with AC 92,100 in Mice: Chronic Toxicity
and Oncogenicity—Mouse: Laboratory Project ID. 8422.
Unpublished study prepared by Tegeris Laboratories, Inc.
1566 p.
4034701 American Cyanamid Company (1987) 28-Day Oral Toxicity Study in
the Dog with AC 92,100: Unpublished study received Oct 14,
1987 under 241-241.
GS0109001 American Cyanamid Company. Residue Studies for the Use
of Counter® 15G As a Cultivation Time Application for
Control of Corn Rootworms. (Unpublished study re-
ceived Nov 10, 1977 under 241-238; CDL:232258)
GS0109002 U.S. Environmental Protection Agency (1975). Report on
the Toxicity of Counter® 15G to Bluegill Sunfish.
Static Jar, Test No. 894, Nov 7, 1975; (unpublished
study prepared by U.S. EPA Chemical and Biological
Investigations Branch, Beltsville, MD)
GS0109003 U.S. Environmental Protection Agency (1975). Report on
the Toxicity of Counter® 15G to Rainbow Trout. Static
Jar, Test No. 909, Dec 12, 1975; (unpublished study
prepared by U.S. EPA Chemical and Biological
109
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Revised Terbufos Standard
GS0109004 U.S. Environmental Protection Agency (1976). Report on
the Toxicity of Counter® 1 5G to Daphnia magna. Static
Jar, Test No. 922, Feb 2, 1976; (unpublished study pre-
pared by U.S. EPA Chemical and Biological Investigations
Branch, Beltsville, MD)
110
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IV. FORMS APPENDICES
1 1
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OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
Wrrtf respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document. I am responding in the following manner:
O I. I will submit data in * timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or re not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. OECO
Chemicals Testing Programme, I enclose the protocols that I will oe:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(8)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my ngistration by deleting the following uses (this option is not available to applicants for new products):
O 5. I request voluntary cancedatioa of the registration of this product (This option is not available ID applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Form 8680-1
SIGNATURE
DATE
112
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OMB A-pproval No.
Expires 11/30/89
2070-0057
(To qutlify, certify ALL fouritamtl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm if willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are atuched. That offer w*s irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2MB)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(8). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
EPA Form 8S80-6
SIGNATURE
1 13
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting 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
-
•
114
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1.
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
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
*
115
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OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
•
EPA Product Registration Number:
Registrant's Name and Address: |
i
i
I
As an authorized representative of the registrant of the product identified '
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFPA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are . .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the rectuired generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
reouirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the recruired data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EPA Form 8570-27
116
-------
2070-0060
CERTIFICATION WITH RESPECT TO CITATION OF DATA
EPA File Symbol/Reg. No. -__ Date of application
Name of Product
Applicant's Name and Address
1. This--application is supported by all data submitted or cited in the
application, in addition, if cite-all options are indicated, this application
is supported by all data in the Agency's files that concern the properties
or effects of this product or of any other product that is identical or
substantially similar, and that is one of the types of data that would be
required to be submitted if this application sought the initial registration
of a product of identical or similar composition and intended uses under
the data requirements in effect on the date of approval of this application.
2. I certify that, for each s'tudy cited in support of this application
for registration that is an exclusive use study, I have obtained the
written permission of the original data submitter to cite that study.
3. I certify that, for each study cited in support of this application
for registration that is not an exclusive use study:
I have obtained the written permission.of the original data suhroitter
to cite that study? or
I have notified in writing the companies who have submitted data I have
cited to support this application and have offered to: (a) Pay compensation
for those data in accordance with section 3(c)(l)(D) and 3(c)(2)(D) of
the Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence-
negotiations to determine which data are subject to the compensation
requirement of FIFRA and the arcount and terms of compensation due, if
any- The companies I have notified are: (Check one)
[ ] All companies listed on the Pesticide Data Submitters List for
all active ingredients contained in my product (Cite-all method or
cite-all option under Selective Method). (Also sign the General
Offer to Pay Statement below.)
{ ] Those companies who have submitted the studies which I have
cited (Selective method)
Date Signature
Title
General Offer to Pay; I hereby offer and agree to pay compensation to
other persons, with regard to the approval of this application, to the
extent required by FIFRA sec. 3(c)(l)(D) and 3(c)(2)(D).
Date Signature
Title
EPA Form (April 1985)
*U. S.COWERNItNT PRINTING Off ICE : 1998-516-002 |80043
1 17
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