&EPA
United State*
Environmental Protection
Agency
Off ice of
Pesticide* and Toxic Subetance*
Washington DC 20460
March 1987
Pesticides
Guidance for the
Reregistration of
Pesticide Products
Containing Methiocarb
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
.CONTAINING
METHIOCARB
(100501)
AS THE ACTIVE INGREDIENT
Case Number 577
CAS 2032-65-7
March, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
I. Introduction 1
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment 6
A. Science Findings
B. Summary of Data Gaps
C. Tolerance Reassessment
IV. Regulatory Position and Rationale 18
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 28
VI. Requirement for Submission of Generic Data 30
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 36
VIII. Requirement for Submission of Revised Labeling 37
IX. Instructions for Submission : ...... 37
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request*, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard/
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be.taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce .the levels of impurities or contaminants-;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to,examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
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— 3 —
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL'COVERED BY THIS STANDARD '
A. Description of Chemical
Common Name: Methiocarb
Chemical Name: 4-Methylthio-3,5-xylylmethylcarbamate
Chemical Class: Carbamate
CAS Number: 2032-65-7
OPP (Shaughessy) Number: 100501
Empirical Formula: CnHi5N02S
Trade Names: Mercaptodimethur, Metmercapturon, Mesurol,
Methiocarbe, Draza, Bay 37344, and H-321
Other Chemical Names: 3,5-dimethyl-4-(methylthio)phenyl-
methylcarbamate; and 4-(methylthio)-
3,5-xylylmethylcarbamate
Physical Characteristics of Technical (T) 3125-258 and pure
methiocarb (P):
Color: White (P,T)
Physical State: Crystalline solid (P,T)
Melting Point: 119 °C (P); 121 °C(T)
Boiling Point: Not distillable
Bulk Density: 35-40 Ib/cu ft (T)
Solubility: In g/L solvent at 20 °C:
water: 3 x 10 ~2 (P)
n-hexane: 2 (P)
dichloromethane: > 200 (P)
2-propanol: 80 (P)
toluene: 70 (P)
In mg/L
water: 27 (P)
Vapor pressure: at 60 °C: 1.5 x 10~4 mbar (P)
at 20 °C: 3.8 x 10~7 mbar (T)
at 25 °C: 8.8 x 10~7 mbar (T)
Octanol/water partition coefficient: 2200
at 20 C (P)
pH - not soluble enough (T)
Stability - half life at 22 °C:
pH 4: > 1 year (P)
pH 7: < 35 days (P)
pH 9: 6 hours (P)
B. USE PROFILE
Methiocarb is a systemic carbamate registered for a variety
of agricultural and nonagricultural outdoor uses and for use in
greenhouses. A versatile pesticide, it is registered as a bird
and rodent repellent as well as an insecticide, acaricide and
molluscicide. It is used mainly as a bird repellent in corn
fields and fruit orchards, and for slug and snail control around
ornamental plants.
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Additional use sites include blueberries/ ginseng, cherries,
citrus fruits, avocados, peppers (as a seed crop), sunflowers
(as a seed crop), nonbearing deciduous fruit trees, shade trees,
ornamental turf, and as a preplant application for unspecified
agricultural crops.
The registered types of application include soil, foliar,
aerial, and broadcast. Registered formulation types include dust,
granular, wettable powder and pelleted/tableted. The wettable
powder formulations contain 75% methiocarb while the dust formu-
lations range from 18.75 to 50%, and the granular and pelleted/
tableted range from 1 to 2%.
There are currently two registered manufacturing use (MP)
products containing methiocarb as a single active ingredient.
One, a technical grade, contains 99%, the other a formulation
intermediate, contains 75%. A total of 30 end-use (EP) products
containing methiocarb are registered under section 3 of FIFRA;
29 contain methiocarb as a single active ingredient and one
contains methiocarb in combination with another active ingredient
(metaldehyde). There are a total of 65 section 24(c) registrations
with 64 containing methiocarb as a single active ingredient and
one containing methiocarb in combination with another active
ingredient (metaldehyde). There are five intrastate products,
all containing methiocarb as a single active ingredient.
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III. AGENCY ASSESSMENT
A. SCIENCE FINDINGS
1. Toxicology
The following is a summary of scientific findings based
on the available toxicology data on methiocarb.
Acute Effects
Technical methiocarb is highly acutely toxic by the
oral route (Toxicity Category I) and of relatively low acute
toxicity by the dermal route (Toxicity Category III). Available
data are not adeguate to assess acute inhalation toxicity and
are reguired. Methiocarb"s primary mechanism of toxicity is
cholinesterase inhibition .and animal studies have shown that the
chemical inhibits plasma, erythrocyte, and brain cholinesterase
activity. , :;
Chronic Toxicity and Oncogenicity Studies
In a two year feeding/oncogenicity study, 60 male and
60 female rats were treated with 0, 67, 200 or 600 ppm of
methiocarb in the diet. The effects of methiocarb administration
in this study were judged to be related to cholinesterase
inhibition. The no-observable effect level (NOEL) was determined
to be 67 ppm (3.35 mg/kg/day). Methiocarb was not oncogenic under
the conditions of this study. A second oncogenicity study (mouse)
is needed to evaluate the oncogenic potential of methiocarb. In
a dog chronic feeding study, effects which appeared to be treatment-
related included sporadic incidences of hind limb weakness and
tremor in the high dose group (240 ppm) and plasma cholinesterase
inhibition of 30 percent or greater at dose levels of 15 ppm and
above. The NOEL was determined to be 5 ppm (0.125 mg/kg/day),
based on plasma cholinesterase inhibition.
Reproduction
The available rat reproduction study is not adeguate to
assess reproductive toxicity potential. A new study is required.
Developmental Effects
Two acceptable developmental toxicity studies are available
to the Agency:
In a rat study, doses of 1, 3 and 10 mg/kg of methiocarb
were administered orally during days 6 through 15 of gestation.
although the high dose group showed evidence of weight loss, no
indication of developmental toxicity was noted. In this study, the
NOEL for maternal effects was 10 mg/kg, and the NOEL for developmental
effects was >10 mg/kg.
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In a rabbit study, the same dosages were administered on
days 6 through 18 of gestation. Again, weight loss was noted in
the high dose group, but there was no evidence of developmental
toxicity. The NOEL for maternal effects in this study was 3
mg/kg, and the NOEL for developmental effects was >10 mg/kg. No
additional data are required.
Mutagenicity
The available mutagenicity studies which consisted of the
following: Salmonella reverse mutation test; a mouse micronucleus
test; a mouse dominant lethal test; and an E_. coli DNA damage test
are not acceptable and new studies are required. Deficiencies
found in these studies included lack of a positive control (mouse
dominant lethal); use of an inappropriate positive control and
failure to demonstrate that the metabolic enzyme preparations
were active (JE. coli DNA damage); data from non-activated assays
were not reported (Salmonella reverse mutation); and micronuclei
may not have been -detected with the single sampling :time employed
(mouse micronucleus).
Metabolism
An assessment of the metabolism of methiocarb cannot be
made at this time since the available metabolism data are
insufficient. In a rat metabolism study a number of metabolites
were reported that were not clearly identified. Only one dose
level was tested and an insufficient number of animals was used.
A new metabolism study is required.
Metabolites
Methiocarb sulfoxide, a metabolite of methiocarb, is also
a cholinesterase inhibitor and in some studies has been found to
be more acutely toxic than the parent compound. The acute oral
toxicity of methiocarb sulfoxide in rats was reported to be 9 mg/
kg (males) and 7 mg/kg (females). A 30-day dog feeding study
conducted with methiocarb sulfoxide is required to assess potential
acute toxicological effects from dietary exposure to residues of
methiocarb sulfoxide in/on methiocarb-treated commodities. The
acute oral toxicities of other potential metabolites of
methiocarb (N-hydroxymethyl methiocarb; N-hydroxymethyl methiocarb
sulfone; and N-hydroxymethyl methiocarb sulfoxide) were all found
to be less than that of methiocarb.
The following summarizes results of acceptable studies
conducted with methiocarb:
Acute oral toxicity (rat) 14-30 mg/kg
Acute dermal toxicity (rabbits) > 2000 mg/kg
Acute delayed neurotoxicity (hen) Negative at 380 mg/kg
(highest dose tested)
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Chronic feeding (rat) NOEL for cholinesterase
inhibition = 67 ppm
(3.35 mg/kg/day)
Chronic feeding (dog) NOEL for cholinesterase
inhibition = 5 ppm (0.125
mg/kg/day)
Oncogenicity (rat) Not oncogenic up to
600 ppm (highest dose
tested)
Teratology (rat) Negative up to 10 mg/kg
(highest dose tested)
Teratology (rabbit) Negative up to 10 mg/kg
(highest dose tested)
The following summarizes results of studies conducted
with some of methiocarb's purported metabolites.
Acute oral toxicity (rat)
Methiocarb sulfoxide 7-9 mg/kg
N-hydroxymethyl methiocarb > 112.0 mg/kg
N-hydroxymethyl methiocarb sulfone > 112.0 mg/kg
N-hydroxymethyl methiocarb sulfoxide > 160.0 mg/kg
2. Ecological Effects
The following is a summary of scientific findings based
on the available data.
Avian Species; The Agency possesses a number-of studies
on the acute and subacute toxicity of methiocarb to avian species.
Although few are sufficient individually to meet Agency require-
ments, in the aggregate they are sufficient to characterize
methiocarb as highly toxic to avian species on an acute basis,
but only slightly toxic at most on a subacute basis. Acute
toxicities range from 2.47 mg/kg (house finch) to greater than
270 mg/kg (pheasants), with the majority of values falling below
20 mg/kg. When fed in the diet, the subacute toxicity ranges
from 1071 (mallard ducks) to >5000 mg/kg (upland game birds).
This difference between the acute and, subacute toxicities
may be due to reduced food consumption. No feed consumption
data were provided for the subacute dietary studies. Results of
pen studies suggest that certain formulations may produce a
repellency effect in some avian species. Because repellency has
not been clearly demonstrated in the available avian toxicity
studies, repellency studies are required. At present, hazard to
avian species is presumed since a lethal dose is clearly available.
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Less than one granule from the registered granular or pelletized
bait and seed treatment methiocarb products would contain the
acute toxic dose for blackbirds (3.2 mg/kg). Therefore, the use
of such products would present a hazard to birds of similar size
and sensitivity .as the blackbird. Larger birds, such as the
mallard duck, would need to ingest 6 to 20 granules to obtain an
acute toxic dose. Although repellency data suggest that medium
to large size birds may be repelled from treated granules,
repellency has not been clearly demonstrated.
Additionally, it is calculated that the application of
methiocarb 75% wettable powder at the maximum application rate
(4.0 Ib ai/A) could result in residues (960 ppm) on the avian
forage item, short grass, approaching the mallard dietary toxic
dose of 1071 ppin. Application of the product, at all application
rates could result in residues on short grass exceeding 1/5 the
dietary toxic dose (214 ppm). At the maximum application rate,
residues on forage/insects are expected to be 230 ppm. The 75%
wettable powder is applied as a spray using aerial or ground
equipment to avian food items as an avian repellent and insecticide,
Residues are therefore expected to be available to birds on a
variety of food and forage items.
Field studies are not available, however, to confirm
these estimated exposure levels from use of methiocarb 75% WP
and full-scale field testing is required. A complete assessment
of the potential risk to avian species from registered uses of
methiocarb cannot be made until both the repellency studies and
the terrestrial field studies are received and evaluated.
Reproduction studies in mallard ducks and bobwhite
quail indicate that no reproductive impairment was caused by
dosages up to 50 ppm (bobwhite quail) and 100 ppm (mallard duck).
Aquatic Species; The data indicate that technical
methiocarb is highly toxic to both coldwater and warmwater fish,
and very highly toxic to freshwater invertebrates on an acute
basis. The 96-hour acute toxicity to rainbow .trout and bluegill
sunfish were 0.436 ppm and 0.734 ppm, respectively. The 48-hour
studies on freshwater invertebrates showed an acute toxicity of
.019 mg/kg.
The available fish early life stage test is not adequate
and additional information is required. Aquatic invertebrate
life cycle data are not available and are required. The available
data on acute toxicity to estuarine and marine organisms are not
adequate and new studies are required.
Based on the available data, aquatic estimated environ-
mental concentrations resulting from the use of methiocarb
granular or pelletized formulations may pose an acute hazard for
aquatic species. The agency used a computer model to simulate
runoff from granular applications of methiocarb to turf.
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The estimated environmental concentrations (EEC) of
methiocarb in the hypothetical ponds and streams of the models
ranged from 0.2 ppb to 23.6 ppb. On the basis of methiocarb
toxicity to aquatic organisms, the EEC levels may pose an acute
hazard to both endangered and nonendangered fish and aquatic
organisms.
The EEC's were also calculated for use of the 75%
methiocarb wettable powder formulation. In shallow water, the
levels ranged from 55.1 ppb to 294 ppb. In deep water, the
levels ranged from 4.5 ppb to 24.5 ppb. On the basis of
methiocarb toxicity to aquatic species, these levels may pose an
acute hazard to both endangered and nonendangered fish and aquatic
organisms.
Though these theoretical calculations and modeling indicate
that certain uses of methiocarb may result in significant adverse
effects to aquatic species, actual field monitoring data are not
available to support this finding. Moreover the environmental
fate characteristics of methiocarb are not accurately defined by
available data. Thus the models can be used only on a limited
basis. When environmental fate for methiocarb are available, the
models can be refined to more precisely predict the EEC.
Aquatic residue monitoring studies will be required to
determine actual residues in aquatic systems exposed to runoff
and spray drift. Full scale aquatic organism field testing may
be required depending on results of the monitoring studies.
The use of methiocarb as a corn seed treatment is not expected to
result in aquatic residue levels of concern because corn is
planted at a depth of 6 cm in the ground. At this depth,
runoff into aquatic systems is likely to be minimal, and is not
likely to pose a hazard to exposed aquatic species.
Nontarget Insects: The available data are sufficient
to characterize methiocarb as highly toxic to honey bees with
high residual toxicity through 3 days posttreatment. The acute
contact toxicity for honey bees is determined to be 0.375
micrograms per bee.
Endangered Species; As described above, methiocarb may
pose a hazard to endangered birds, insects and aquatic organisms.
The U.S. Fish and Wildlife Service has reviewed other chemicals
having uses on corn or turf. The use of methiocarb on corn and
turf were found to pose potential hazards to some.endangered
species.
The Agency has developed endangered species labeling, which
will be required by separate notice once the Agency receives
concurrence from the U.S. Fish and Wildlife Service.
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3. Environmental Fate; Few adequate studies are available
to evaluate the environmental fate of methiocarb. With the
exception of a leaching study for the parent compound on one soil
type/ and rotational crop studies for grain and root crops, none
of the environmental fate data requirements to support the
registered uses of methiocarb have been fulfilled.
There are insufficient data to make a determination
regarding the potential for methiocarb to reach ground water.
Additional data are required including field dissipation and aged
leaching studies addressing all the degradates. A full battery
of environmental fate data, including hydrolysis, photodegradation,
soil metabolism, leaching, soil dissipation and crop and fish
accumulation studies are required.
4. Reentry
. The available reentry data were inadequate and studies
are required to assess the potential exposure to humans entering
areas treated with methiocarb. The sampling protocol was inadequate
and the data were too variable to adequately assess the dislogeable
residues, on the tested crop. Studies are required on foliar and
soil dissipation as well as dermal and inhalation.
B. SUMMARY OF DATA GAPS
Toxicology - generic
Acute inhalation - rats
21-day dermal toxicity
30-day feeding (dog) with methiocarb sulfoxide
Mouse oncogenicity study
Reproductive effects
Mutagenicity testing
General metabolism study
Residue Chemistry
Livestock metabolism (ruminants and poultry)
Analytical methodology for plants and animals
Data on levels of residues in: citrus fruits, cherries,
blueberries, and corn
Tolerance proposals and/or residue data to support the
following uses: avocados; pepper and sunflower seed
crops; preplant application for agricultural
crops, and non-bearing deciduous fruit trees.
Ecological Effects
Field testing for mammals and birds
Avian repellency test
Acute toxicity for estuarine and marine organisms
Fish early life stage
Aquatic invertebrate life cycle
Aquatic residue monitoring
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Environmental Fate;
Hydrolysis
Photodegradation - water and soil
Soil metabolism - aerobic and anaerobic
Leaching and adsorption/desorption
Soil dissipation
Confined rotational crop
Fish accumulation
Reentry studies
C. Tolerance Reassessment
Tolerances have been established for residue of methiocarb
and its cholinesterase-inhibiting metabolites in or on blue-
berries, cherries, citrus fruits, corn, and peaches. The tol-
erances for blueberries and cherries are interim tolerances, due
to expire on March 31, 1989. Refer to 40 CFR 180.320.
Commodity U.S.
Blueberries 5.00
Cherries 5.00
Citrus fruits 0.02
Corn, forage 0.03
and fodder
Corn, fresh 0.03
Corn, grain 0.03
(field and
popcorn)
Peaches 15.00
Canadian
Mexican
Codex
0.05f/
(proposed)
0.053/
(proposed)
The food additive tolerances listed for methiocarb under
21 CFR 193.145 and 21 CFR 561.175 were temporary tolerances
established to cover residues in or on grape food and feed items
resulting from application of the pesticide to grapes under an
experimental use permit. These temporary tolerances and the
experimental use permit expired on December 31, 1980.
The sum of methiocarb, its sulfoxide and its sulfone.
A decision regarding the potential for compatibility
between the pending Codex and the U.S. tolerances for
citrus fruits and sweet corn cannot be made until the
adequacy of the U.S. tolerances for these commodities
has been ascertained.
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At present, the methiocarb tolerances are expressed as
residues of methiocarb and its cholinesterase inhibiting
metabolites. Heretofore, methiocarb, methiocarb sulfoxide and
methiocarb sulfone have been considered the residues of concern
in both plants and animals. A determination whether other
metabolites are considered to be of toxicological concern
cannot be made in the absence of adequate metabolism data.
The Agency will evaluate the required animal metabolism studies
on an expedited basis in order to make this determination as
soon as possible. The requirement for additional studies is
also contingent upon the results of these animal metabolism
studies. . ^
In the event that there are metabolites found in plants
that are not found in the animal metabolism studies, additional
testing may be required. Also, a determination of whether
metabolites in addition to methiocarb and its sulfoxide and
sulfone should be sought in plant residue studies as well as in
residue analytical methods, cannot be made until animal metabolism
studies have been received and evaluated. Such information may
be necessary should it be determined that metabolites other than
methiocarb's sulfoxide and sulfone are of toxicological concern.
Because of the residue chemistry and toxicology data
gaps, the Agency cannot conduct a tolerance reassessment until
the required data are submitted and reviewed.
There are several registrations for crops determined to
be food uses for which no tolerance exists. Tolerance proposals
and supportive residue data are required to support these uses
which are as follows: pepper and sunflower crops grown for seed;
avocados ; and preplant application for agricultural crops (the
crops must be specified).
Additionally, residue data and specification of the
intended fruit tree crops must be provided to support the current
registered use on "nonbearing deciduous fruit trees."
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1. Residue Data.
The residue data reviewed in support of these tolerances
include the following:
a. Data on the nature of the residues in both plants
and animals, including identification of major metabolites
and degradates of methiocarb. The residues of concern
currently included in the tolerance expression include
methiocarb, methiocarb sulfoxide and methiocarb sulfone.
The Agency can draw no conclusions about the toxicological
significance of other plant or animal metabolites at this
time.
b. Radiolabeled studies on the uptake, translocation
and metabolism of methiocarb in plants which show that
methiocarb undergoes two routes of metabolic breakdown
in plants. Methiocarb may be oxidized to the sulfoxide
(MSO) and thereafter hydrolyzed to methiocarb sulfoxide
phenol (MSOP). These metabolites may be further oxidized
and hydrolyzed to yield methiocarb sulfone (MSC>2) or
methiocarb sulfone phenol (MSC^P). A secondary metabolic
route is the hydrolysis of methiocarb to the phenol (MP).
c. Radiolabeled studies on the metabolism and translocation
of methiocarb in cows and chickens. The metabolism of
methiocarb in animals is not well understood. Available
information again suggests two pathways of metabolism.
The major route in both chickens and ruminants appears
to be hydrolysis to methiocarb phenol (MP) followed by
oxidation to methiocarb sulfoxide phenol (MSOP).
Additional metabolism studies in ruminants and poultry
are required.
d. Analytical methodology for determining the levels of
residues of methiocarb in plants and animals. Two gas
chromatographic methods have been proposed for residue
collection and enforcement for plants; however,
inconsistencies in these methods (significant variation
in recoveries and differing extraction methods) preclude
the Agency from determining that one or both are
adequate. Adequate GC methods exist for the collection
of residue data in animals, but an enforcement method must
be developed and validated. If additional metabolites of
concern are identified in metabolism studies, methods for
residue collection and enforcement must be developed.
e. Storage stability data demonstrating that residues
of methiocarb are stable in succulent crops for up to
one year and in dried grain for up to 3 months. In
animals, residues have been shown to be stable for up
to two months. No additional data are required at this
time; however, if additional metabolites of concern are
identified in metabolism studies, storage stability data
for those residues will be required.
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f. Data on the magnitude and levels of residues of
methiocarb in individual raw agricultural commodities,
animal products and processed food and feed derived
from raw agricultural commodi.ties. Available data are
insufficient to determine the adequacy of tolerances in
citrus, corn (all varieties), corn fodder and forage,
cherries, and blueberries.
Although data have been submitted in support of tolerances
in meat and milk, the Agency has not yet determined the
adequacy of these data. If additional metabolites of
concern are identified in required metabolism studies,
additional residue data may be required. Moreover,
adequate data are not available for a number of crops
that constitute significant sources of animal feed.
The Agency's determination will depend on the results
of animal metabolism studies and adequacy of data on
commodities used for animal feed.
Available data are insufficient to determine the magni-
tude of residues in processed food and feed items. No
processing studies are required at this time. However,
processing studies may be required for corn if measurable
residues are found at exaggerated rates.
Table A of Appendix I describes residue data requirements in
detail.
g. Food and Drug Administration (FDA) Monitoring Data
Total Diet Study Data
From April 1982 to January 1986, a total of 15 market
baskets were collected consisting of 72 individual
food items per market basket. Out of a total of
1080 samples analyzed throughout these years, only
one sample of orange juice from the June 1983
collection date bore measurable residues of methio-
carb or its sulfoxide. This sample bore 0.009 ppm
of methiocarb (well below the 0.02 ppm tolerance
established for citrus fruit). The analytical method
used during the collection years was capable of
determining methiocarb and its sulfoxide.
Domestic and Import Surveillance Data
No residues exceeding tolerances were found in the
FDA domestic surveillance data (1978 to present) for
crops having established tolerances for methiocarb.
15
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2. Toxicology Data
The following is a summary of toxicology data reviewed
in support of these tolerances.
a. Chronic Toxicity
A 2-year rat feeding study with a NOEL of 100
ppm or 5 mg/kg/day (the highest dose tested) for both
systemic effects and cholinesterase inhibition had
originally been used to calculate the Acceptable
Daily Intake (ADI) for residues of methiocarb. Using
a safety factor of 100, the original ADI was 0.05
mg/kg/day. This study, which is now considered a
supplementary study, had been used to support the
tolerance of 15.0 ppm for peaches and the original
25.0 ppm tolerances for blueberries and cherries.
Subsequently, both a new 2-year rat feeding study
and a 2-year dog feeding study were submitted and
found acceptable. The new rat study showed a systemic
NOEL of 600 ppm (highest dose tested) and a cholines-
terase inhibition NOEL of 67 ppm (3.35 mg/kg/day).
The lowest effect level (LEL) for cholinesterase
inhibition (red blood cell) was 200 ppm. The dosage
levels tested were 0, 67, 200, and 600 ppm.
The current ADI for residues of methiocarb is
based on the 2-year feeding study in the dog (the
most sensitive species). In this study, the NOEL was
determined to be 5 ppm based on plasma cholinesterase
inhibition and the LEL for cholinesterase inhibition
(plasma) was determined to be 15 ppm. At dose levels
of 15 ppm and above, plasma cholinesterase activity
was depressed 30% or greater. The NOEL and LEL for
systemic effects were determined to be 60 ppm (1.5
mg/kg/ day) and 240 ppm (6.0 mg/kg/day), respectively.
The highest dose tested (240 ppm) was also the NOEL
for brain and erythrocyte cholinesterase inhibition.
The dosage levels tested were 5 ppm (reduced from
15 ppm at study week three), 60, and 240 ppm.
Utilizing the NOEL of 5.0 ppm (0.125 mg/kg/day)
from the dog study and a safety factor of 10, (for
cholinesterase inhibition), the current ADI is 0.0125
mg/kg/day. Based on the established tolerances and a
daily food intake of 1.5 kg for a 60 kg individual,
the theoretical maximum residue contribution (TMRC)
of methiocarb in the daily diet is 0.003575 mg/kg/day
and the TMRC is 27.5% of the ADI.
16
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b. Methiocarb sulfoxide
The available toxicity data for methiocarb's
metabolite, methiocarb sulfoxide, are inadequate to
assess the potential acute toxicological effects
which may result from dietary exposure to sulfoxide
residues in/on methiocarb treated commodities. A
30-day dog feeding study conducted with methiocarb
sulfoxide is required. Results of this study will be
considered in the Agency's reassesment of the methiocarb
tolerances.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
1. The Agency is not placing methiocarb into Special
Review at this time. Field studies are required to completely
assess the potential risk to wildlife, including endangered
species.
Rationale;
Based on estimated concentrations of methiocarb on seeds
and in granular formulations, current registered uses of the
chemical as granular bait formulations and seed treatments
theoretically could expose terrestrial organisms to residue
levels exceeding risk criteria for special review in 40 CFR 154.7.
The information is not sufficient, however, to initiate special
review. Full field studies and repellency studies are required
to completely assess the hazard posed by these uses.
Theoretical calculations also indicate that the use of
certain methiocarb formulations 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. Aquatic residue
monitoring studies will be required to determine actual residues
in aquatic systems receiving runoff and spray drift. Upon receipt
and evaluation of the monitoring studies, a determination will be
made whether full scale aquatic organism field testing will be
required or whether regulatory action is appropriate.
2. All outdoor agricultural and commercial uses of
methiocarb are restricted for use by certified applicators or
workers under their direct supervision on an interim basis
pending submittal and evaluation of the required terrestrial
field, avian repellency and aquatic residue monitoring studies.
With the exception of the corn seed treatment use, the
outdoor uses are restricted due to avian, fish and aquatic
organisms toxicity. The corn seed treatment is restricted due
to avian toxicity. Those products previously designated as
restricted use products (EPA Reg. Nos. 4-254 and 2393-327) will
remain as such.
Rationale;
Section 3(d)(l)(C) of FIFRA provides that some or all
uses of a pesticide will be classified for restricted use if the
Administrator determines that without such restriction the pesti-
cide "may generally cause unreasonable adverse effects on the
environment."
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In the case of methiocarb, the Agency has determined that
the commercial and agricultural uses potentially cause adverse
effects on avian and aquatic species.
This determination is based on the very high acute toxicity
of methiocarb to avian, fish and aquatic species. Calculations
utilizing this high acute toxicity and the registered application
rates show that avian species could be exposed to a lethal dose
of the chemical. Calculations also show that the estimated
environmental concentrations of methiocarb residues in the aquatic
systems exposed to runoff and drift from registered uses of the
chemical may be expected to result in adverse effects to fish and
aquatic organisms.
There are no substantiated reports of widespread fish
and/or wildlife kills attributed to registered uses of methiocarb.
The lack of substantiated fish and wildlife incidents does not
serve as evidence that none have occurred. However, it does give
the Agency cause to believe that application of methiocarb products
by persons knowledgeable in use of the chemical will mitigate the
potential risk to nontarget wildlife.
By virtue of the substantially smaller area generally
treated by the individual homeowner in relation to that treated
by an agricultural or commercial user, it is not expected that
the use of methiocarb by the homeowner could cause an adverse
effect on the environment.
3. No new permanent tolerances will be granted pending
submittal and evaluation of data required to ascertain and validate
an appropriate analytical method for the enforcement of tolerances
for residues of methiocarb and any metabolites deemed to be of
toxicological concern.
Rationale; A review of the various available methods
and confirmatory procedures gives the Agency cause to question
the appropriateness of the methods available for enforcement
of methiocarb tolerances and for collection of residue data in
plant commodities.
4. No tolerances may be set for methiocarb in commodities
intended for human consumption at residue levels exceeding 5.0 ppm
At present, there is one established tolerance over 5.0 ppm
(peaches at 15.0 ppm), and the Agency will revoke this tolerance.
Rationale; Tolerances previously established for
peaches at 15 ppm, blueberries at 25 ppm, and cherries at 25 ppm
based on old studies can no longer be toxicologically supported.
The Agency's policy is not to establish tolerances at levels
greater than the NOEL.
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5. In a separate notice, endangered species labeling
will be required for the following raethiocarb uses: corn seed
treatment, bait application to corn and use on turf (golf courses
and sod farms). The notice will be issued after concurrence on
the proposed labeling from Fish and Wildlife Service, U.S.,
Department of Interior.
Rationale; The corn seed treatment, corn bait application
and turf (golf courses and sod farms) uses of methiocarb may pose
potential hazard to endangered species. In order to protect
endangered species in areas where methiocarb is used on corn and
turf, endangered species labeling will be required once the
Agency receives concurrence from the U.S. Fish and Wildlife
Service. At that time, a PR (Pesticide Registration) Notice
will be issued in order to notify registrants of the final label
requirements for endangered species. Consultation with the U.S.
Fish and Wildlife Service will be undertaken to determine whether
other uses of methiocarb will jeopardize endangered species.
6. The current label use on "non-bearing deciduous fruit
trees" must be revised to specify the fruit tree(s) intended.
Residue data must be submitted to support non-food classification
or a tolerance.
Rationale; The claim "non-bearing deciduous fruit trees"
is too broad.
Previously the use of pesticides on fruit trees (trees
which will not bear fruit within one year of application) was
considered a non-food use. Current Agency policy is that non-
bearing trees are considered a non-food use only if data
demonstrate that no detectable residues occur in the crop at the
first harvest (one year after application). If residues are
detected, then a petition for tolerance with the full range of
residue chemistry data requirements will be needed.
7. The current label use as a preplant soil application
for agricultural crops must be revised to specify the crops
intended. Tolerance proposals and supporting data are required
for any crop for which a tolerance has not been established.
Rationale; The term, "agricultural crops", is too
broad. There are no tolerances established nor residue data
available to cover such a broad use for methiocarb. The current
registered use is limited to use in Oregon under a 24(c) special
local need state registration which expires in October, 1987.
8. Tolerance proposals and supporting residue data must
be submitted to support the use of methiocarb on avocadoes and
on pepper and sunflower crops grown for seed.
Rationale; There are no tolerances established nor
residue data available to cover such uses.
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9. An avian repellency study and an aquatic residue
monitoring study are required to support the continued registration
of all current outdoor uses of methiocarb.
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 methiocarb.
Refer to Section A. 2. in Chapter II of this document for a
discussion of the potential risks based on available data.
10. The Agency is imposing a 24 hour reentry interval
on an interim basis pending submittal and evaluation of the required
reentry data. This reentry labeling restriction is being imposed
for the use of methiocarb on commercial tUrf and commercially grown
ornamentals; agricultural crops (with the exception of the seed
treatment uses), and in greenhouses.
Rationale; Current data are not adequate to establish
a definitive reentry interval. Establishment of an interim
reentry interval is based on the high acute oral toxicity properties
of technical grade methiocarb and the high likelihood of exposure
to methiocarb residues of workers who perform activities in the
treated sites specified above. It is not expected that the use
of methiocarb as a seed treatment would result in exposure to
field workers entering fields in which the treated seed has been
planted.
11. The Agency is imposing work safety and protective
clothing statements for end-use products containing from 20% to
75% methiocarb.
Rationale; These statements are reflective of
the dermal toxicity category III of these products and provide
specific guidance for persons handling methiocarb products.
There are no registered end-use products containing more than 75%
methiocarb.
12. A 30-day dog feeding study conducted with
methiocarb's metabolite, methiocarb sulfoxide, is required.
Rationale; This study is required to assess the
acute hazard potential of methiocarb sulfoxide. In some toxicology
studies, methiocarb sulfoxide was shown to be more acutely toxic
than methiocarb. The acute toxicities of both methiocarb and
methiocarb sulfoxide are associated with cholinesterase inhibition.
13. 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 as soon as they are received by the Agency:
21
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§158.125 - Residue Chemistry
171-4 - Livestock metabolism
171-4 - Analytical method for plant residues
§158.130 - Environmental Fate
162-1 - Aerobic soil metabolism
164-1 - Field dissipation studies - soil
165-1 - Confined rotational crop
§158.135 - Toxicology
81-3 - Acute inhalation
82-1 - 30-days feeding (dog) with methiocarb sulfoxide
85-1 - General metabolism
§158.140 132-1,2,3,4 - Reentry Studies
§158.145 - Ecological Effects
70-1 - Aquatic residue monitoring
70-1 - Avian repellency
71-5 - Actual field testing for mammals and birds
72-4 - Fish early life-stage and invertebrate life
cycle
14. While the required data are being developed, currently
registered manufacturing-use products (MP's) and end-use products
(EP's) containing methiocarb may be sold, distributed, formulated
and used subject to the terms and conditions specified in this
Standard. Registrants must provide or agr.ee to develop and
provide additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not
normally cancel or withhold registration simply because data are
missing or are inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory changes
are necessary.
B. CRITERIA FOR REGISTRATION
To be reregistered under this Standard, manufacturing-use
products (MP's) must contain methiocarb as the sole active
ingredient, bear required labeling, and conform to the product
composition, acute toxicity limits, and use pattern requirements
listed in this document.
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C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this.standard,
manufacturing-use products (MP's) must contain methiocarb as the
sole active ingredient. Each MP formulation proposed for
registration must be fully described with an appropriate
certification of limits, stating maximum 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 products containing methiocarb provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3. Use Pattern's
To be registered under this Standard, manufacturing-use
products may oe 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.
The use patterns currently registered for methiocarb are:
Terrestrial - food; *agricultural crops
(preplant);**avocado (soil application);
blueberry; cherry; citrus fruits (soil
application to bearing trees); **citrus fruits
(foliar application on nonbearing trees); corn
(seed treatment); **deciduous fruit trees
(nonbearing); **peppers (grown for seed);
**sunflower (grown for seed).
Terrestrial - nonfood; corn (grown for decorative
purposes); crucifers (grown for seed); ornamen-
tal plants (including ground cover, flowering
plants, shade trees, turf, woody shrubs, and vines);
ginseng *
Greenhouse - nonfood; ornamental plants
Domestic - outdoor; ornamental gardens; lawns;
around building foundations
*The agricultural crops use is currently registered as a special
Local need registration under 24(c) of FIFRA and is limited for
use in Oregon only.
** These crops, previously considered nonfood uses must be supported
by residue chemistry data for continued registration.
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D. REQUIRED LABELING
All products must bear appropriate labeling as specified
in 40 CFR 162.10, PR Notices, 83-2 and 83-3, and below. Appendix
II contains information on label requirements.
Pesticide products containing methiocarb as an active ingredient
may not be released for shipment by the registrant after
April 30, 1988 unless the product bears amended labeling which
complies with the requirement of this Standard.
Pesticide products containing methiocarb as an active ingredient
may not be distributed, sold, offered for sale, held for sale,
shipped, delivered for shipment, or received and (having been so
received) delivered or offered to be delivered by any person
after April 30, 1989 , unless the product bears amended labeling
which, approved by EPA, complies with the requirements of this
Standard.
Ingredients Statement
The ingredient statement for all methiocarb products must
list the active ingredient as:
ACTIVE INGREDIENT(S) :
methiocarb (4-methylthio-3,5-
xylyImethyIcarbamate)
1. Manufacturing-Use Products
In addition to the appropriate precautionary labeling
designated in 40 CFR 162.10, the labels of all manufacturing-use
products must contain the following statements:
0 For formulation into end-use insecticide:
molluscicide; acaricide; bird repellent;
rodent repellent [specify one or more]
products intended for [specify the
appropriate use pattern/uses listed in
section C.3 . ] .
0 This pesticide is toxic to fish and very highly
toxic to birds. Do not discharge effluent con-
taining this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless this
product is specifically identified and addressed
in an NPDES permit. Do not discharge effluent
containing this product to sewer systems without
previously notifying the sewage treatment plant
authority. For guidance, contact your State
Water Board or Regional Office of the EPA.
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2. End-Use Product Labeling
a. The following statement must appear on the front panel
of end-use labeling for use of methiocarb as a corn seed treatment.
RESTRICTED USE PESTICIDE
Due to Avian Toxicity
For retail sale to and use only by certified
applicators or persons under their direct
supervision and only for those uses covered
by the certified applicator's certification.
b. The following statement must appear on tl^e front
panel of end-use labeling for current registered outdoor commercial
and agricultural uses of methiocarb other than the corn seed
treatment use.
RESTRICTED USE PESTICIDE
Due to Avian Toxicity and Fish and Aquatic
Organism Toxicity
For retail sale to and use only by certified
applicators or persons under their direct super-
vision and only for those uses covered by the
certified applicator's certification.
c. Methiocarb products intended for outdoor use must bear
the following statement on the product label:
This product is highly toxic to bees exposed to
direct treatment or residues on blooming crops
or weeds. Do not apply this product or allow
it to drift to blooming crops or weeds if bees
are visiting the treatment area.
d. The following statements must appear on labeling for the
following specified uses:
Outdoor Uses Other Than Granular and Pelletized Bait
and Seed Treatment
This pesticide is toxic to fish and very highly toxic
to birds. Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Drift and runoff from treated
areas may be hazardous to aquatic organisms in neighboring
areas. Do not contaminate water by cleaning of equipment or
disposal of wastes.
25
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Granular or Pelletized Bait for Mollusdicide Use
This pesticide is toxic to fish and very highly toxic to
birds. Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Runoff from treated areas may be
hazardous to aquatic organisms in neighboring areas. Do not con-
taminate water by cleaning of equipment or disposal of wastes.
Seed Treatment
This pesticide is toxic to fish and very highly toxic
to birds. Cover and incorporate spills. Do not contaminate
water by cleaning equipment or disposal of wastes.
e. The following statement must appear on the labeling
for commercial turf and commercially grown ornamentals; agricultural
crops (with the exception of seed treatments); and in greenhouses.
Do not enter treated areas for 24 hours after
application unless protective clothing is worn.
f. The following protective clothing and work safety
rules must appear on labeling for end-use products containing
from 20% to 75% methiocarb.
REPEATED OR PROLONGED EXPOSURE TO CHOLINESTERASE
INHIBITORS SUCH AS ARE CONTAINED IN THIS PRODUCT
MAY CAUSE SUSCEPTIBILITY TO ADVERSE EFFECTS FROM
VERY SMALL DOSES OF ANY CHOLINESTERASE INHIBITOR.
Keep all unprotected persons, 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 of the label.
WEAR THE FOLLOWING PERSONAL PROTECTIVE EQUIPMENT
DURING MIXING, LOADING, APPLICATION, REPAIR AND
CLEANING OF MIXING/LOADING/APPLICATION EQUIPMENT,
DISPOSAL OF THE SPRAY SOLUTION, AND EARLY REENTRY
INTO TREATED AREAS BEFORE [SPRAYS HAVE DRIED or
DUST HAVE SETTLED, as applicable]: long sleeve
shirt, long pants, shoes, socks, chemical-resistant
gloves.
IMPORTANT! Always wash hands, face, and arms with
soap and water before smoking, eating, drinking, or
toileting.
(continued next page)
26
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AFTER WORK: Before removing gloves, wash them with
soap and water. Wash hands, face, and arms with soap
and water. Launder all clothing worn during use with
this product before reusing. Launder this clothing
separately from household clothing. Clothing or gloves
that have been heavily contaminated or drenched must be
destroyed according to state and local regulations.
1 HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.
g. In addition to the statements specified in item f., above,
products containing from 20% through 75% methiocarb with directions
for aerial application must bear the following label statements.
DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE IN
TOTALLY ENCLOSED VEHICLES.
Aerial applicators are not required to wear chemical
resistant gloves if in an enclosed cockpit.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and fi2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active' ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter- into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contcin the following language or its equivalent:
32
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c) (2) (B) (i'ii).
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.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
33
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
34
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All .data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
35
-------
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
36
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions/ reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
37
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
' Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any.
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your'proposed course of action.
38
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C. End Use Products containing the subject pesticide as sole
active ingredient. •. ,
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
39
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E. Addresses
The required information must be submitted to the following
address:
William H. Miller (PM 16)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
40
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TGUIDE-l
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use productv
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
'specifically named in Column 2 or in footnotos to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table
-------
42
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this, data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of twovrequired species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
(his column will usually indicate YES* In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? I/ Citation I/
Must Additional Timeframe
Data Be Submitted? for
. Submission 2/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and TGAI All
Disclosure of
Ingredients
61-2 - Description of TGAI All
Beginning Materials
and Manufacturing
Process
61-3 - Discussion of Formation TGAI All
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI All
of Product Samples
62-2 - Certification of TGAI All
Limits
62-3 - Analytical Methods TGAI All
to Verify Certified
Limits
Physical and Chemical Characteristics
63-2 - Color TGAI All
Yes
Yes
Yes
Yes
Yes 3/
Yes
6 Months
6 Months
6 Months
OsJ
12 Months
12 Months
12 Months
Yes .
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? I/ Citation I/ Data Be Submitted? for
Submission 2/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
- Physical State
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- pH
- Stability
Requirements
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
All
All
All
All
Yes
Yes
Yes
No _4/
Yes
Yes
Yes
Yes
Yes
No 5/
Yes
6 Months
6 Months
6 Months
6 Months -C*
.£*
6 Months
6 Months
6 Months
6 Months
6 Months
64-1 - Submittal of Samples
TGAI, PAI All
Reserved 6/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.120 Product Chemistry Footnotes
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
indicated.
3/ The product chemistry data submission under 62-2 must also include the following: All nitrosamines must be
identified and quantified in six samples of each product; two samples of each must be analyzed shortly after
production, 3 months after production and 6 months after production. A method sensitive to 1 ppm of N-nitroso
contaminants must be used. An upper limit must be provided (and certified) for all nitrosamines found.
4/ Not required since technical methiocarb is a solid at room temperature.
5/ Not required since technical methiocarb is not soluble enough in water.
6/ If samples are needed, the Agency will request them.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
for I/
Submission
§158.125 Residue Chemistry
171-2 - Chemical Identity 2/
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
PAIRA
(See index)
Yes
- Livestock
PAIRA
Partially
171-4 - Residue Analytical
Method
- Plant Residues
TGAI &
Metabolites
Partially
00036496,
00116555,
00124968,
00125530,
00155046,
00155055,
00155057.
00046450,
00046451,
00116555,
00125528,
00155057.
00035520,
00035522,
00035524,
00046448,
00046453,
00056045,
00115224,
00116555,
No
45*.
ON
Yes3/4/
18 months
Yes 5a/5b/
5a/ - 15 months
5b/ - Dec. 31,
1987
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHKXAFB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
for I/-
Submission
§158.125 Residue Chemistry (continued)
171-4 - Residue Analytical
Method (continued)
- Animal Residues
TGAI &
Metabolites
Yes
171-4 - Storage Stability
Data
TEP &
Metabolites
Partially
171-4 - Magnitude of the Residue
Crop Field Trials
00125530,
00125532,
00125537,
00127630,
00127632,
00127634,
00155057,
GS0577001.
00116555,
00125532,
00127630,
00154537,
00155057,
GS0577002.
00046449,
00056047,
00116555,
00125530,
00127630,
00158770.
No
y
Reserved
- Citrus Fruits Group
EP
Partially
00056044.
Yes 8/9/10/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR METHIOCARB
Data Requirement
Test
Substance
Does EPA
Have Data?
B i bliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
for I/
Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Crop Field Trials (continued)
- Stone Fruits Group ll/
o Cherries
12/
o Peaches
- Small Fruits and
Berries Group 18/
o Blueberries
Cereal Grains 23/
Group
o Corn, Fresh and
Field (Including
Popcorn)
EP
Partially
EP
Partially
TEP
Partially
00123980,
00158770.
00123980.
00127628,
00127635,
00155057,
00158770.
00035523,
00037132,
00155042,
GS0577003.
Yes 12/13/14/
15/16/
OO
Yes 19/20/21/22/
Yes 24/25/26/27_/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic Must Additional Timeframe
Citation Data Be Submitted? for I/
Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Crop Field Trials (continued)
- Forage, Fodder and
Straw of the Cereal
Grains Group 28/
o Corn Forage, Fodder TEP
and Silage
- Meat/Milk/Poultry/
Eggs —
- Miscellaneous Crops
0 Deciduous Fruit Trees TEP
(non-bearing)
0 Peppers and Sunflowers TEP
Grown for Seed
0 Avocadoes TEP
0 Agricultural Crops
(preplant application) TEP
Partially
No
No
No
No
00035523,
00037132,
00155042.
Yes 29/
Reserved 30/
Yes 31/
Yes 32/
Yes 33/
Yes 34/
\O
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.125 Residue Chemistry Footnotes
I/ Due dates refer to the number of months following issuance of the Registration Standard, unless otherwise
indicated.
2/ Refer to Product Chemistry Data Requirement tables.
3/ Metabolism studies utilizing ruminants and poultry are required. Animals must be dosed for 3 days with
ringlabeled [14C]methiocarb at a level sufficient to permit complete characterization 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 identity of residues must be determined in milk, eggs, liver,
kidney, muscle, and fat. Should the metabolism of methiccarb in ruminants and poultry be found to differ
significantly, studies of swine metabolism may be required.
4/ Samples from studies required in footnote 3 should be analyzed using the QC method described in Mobay Chemical
Company's Report No. 49078 (or an appropriate substitute which may be used for enforcement purposes) to
ascertain the usefulness of the method for enforcement purposes. C_n
O
5a/ Residues of methiccarb sulfone in or on crop samples must be subjected to analysis by the multiresidue
protocols. Protocols for methods I, II, III, and IV are available from National Technical Information
Service under Order No. PB 203734/AS.
5b/ The following must be submitted: a side-by-side comparison of the PAM II procedure (Mobay Report No. 25168),
the confirmatory method in Report No. 27147, and the method in Report No. 45089 using incurred residues.
These additional data requirements were previously imposed on the sponsor of the data in the Agency letter
dated June 12,. 1986. Therefore, the submittal due date for the data reflects the timeframe imposed in that
letter. The data due by December 31, 1986 (an explanation as to why no HC1 is used in the extraction solvent
in the method in Report No. 45089) have been submitted and are currently under evaluation by the Agency.
If it is determined that plant metabolites in addition to the sulfoxide and sulfone are of toxicological concern,
valid enforcement methods to determine such metabolites must be submitted.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.125 Residue Chemistry Footnotes (continued)
6/ If the requested animal metabolism data and toxicology data indicate metabolites of concern in addition to the
sulfoxide and sulfone/ data depicting the stability of these metabolites in frozen plant and animal tissues will
be required.
2/ Adequate gas chromatographic methods are available for collection of data pertaining to methiocarb residues of
current concern in animal tissues. Refer to footnote 4 regarding the data needed to ascertain the usefulness of
the method for enforcement purposes.
8/ Data depicting methiocarb residues of concern in or on oranges, lemons, and grapefruit harvested 1 year after the
last of four foliar applications (by ground equipment) of the 75% WP at 1.5 Ib ai/A/application on nonbearing
citrus trees. An adequate residue analytical method must be used for collection of data. Tests on oranges must
be conducted in FL(69%) and CA(29%) (State production percentages follow abbreviations parenthetically); grapefruit
tests must be conducted in FL(76%), CA(14%), and TX(6%); and lemon tests must be conducted in CA(81%) and AZ(19%)
(Agricultural Statistics, 1985, p. 198). Data must be submitted within 30 months of Agency notification of an
approved residue analytical method. {j
9/ If the method in Mobay Report No. 45089 is found to be invalid, data are required depicting methiocarb residues
of concern in or on oranges, lemons, and grapefruit harvested after the last of two broadcast soil applications
(by ground equipment) with the 2% G or the 2% P/T formulations (in separate tests) at 0.94 Ib ai/A using an
adequate residue analytical method for data collection. Tests must be conducted in CA where use of these
formulations is permitted under EPA SLN's CA780040, CA780116, CA780158, CA790146, and CA790249. Alternatively,
if the method in Report No. 45089 is found to be valid, it must be ascertained that the method has been validated
at the tolerance level of 0.02 ppm. (Presently, the lowest fortification level tested is 0.05 ppm.) Data must
be submitted within 18 months of Agency notification of an approved residue analytical method.
Testing with the 2% formulation at 0.94 Ib. a.i./A as described in the proceeding paragraph would suffice for
residue testing required to support the existing 1% granular formulations registered under Section 3 of FIFRA.
This Section 3 registered product has an application rate of up to 0.5 Ib. a.i./A applied as a soil application
and may be applied in states other than California. Testing with the 1% granular formulation would be needed
should registrants choose not to support the 2% granular formulation. Tests must then be conducted on oranges
in Florida and California; on grapefruit in Florida, California and Texas; and on lemons in California and Arizona.
All residue data must be collected using an adequate analytical method. Data must be submitted within 18 months
of Agency notification of an approved analytical method.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.125 Residue Chemistry Footnotes (continued)
10/ Residues must be determined in pulp (dehydrated), molasses, oil, and juice processed from citrus fruit bearing
measurable weathered residues. If residues are found to concentrate in any of these processed products, appropriate
food/feed additive tolerances must be proposed. It may be necessary to use exaggerated rates to obtain measurable
residues in the raw agricultural commodity. Data must be submitted within 36 months of Agency notification of an
approved residue analytical method.
_11/ The following additional items would be needed to support a crop group tolerance should such a tolerance be
sought. Use directions must be proposed, and appropriate supporting residue data submitted for the additional
representative group members peaches and plums (fresh prunes).
12/ Because both methods used to collect data are currently being evaluated, data requirements will be contingent upon
the adequacy of the methods. If the Mobay method designated in Report No. 25168 is judged adequate then data
requirements in 13/ below must be met. If the method designated in Report No. 45089 is judged adequate and that
in Report No. 25168 is inadequate, the data requirements in 14/ below must be met. If both methods are judged
inadequate, then data requirements in 15/ and 16/ below must be met. (_
13/ The 24(c) registrants must propose reduced use rates, reduced seasonal use rates, and/or an increased PHI, and
submit appropriate supporting data front studies conducted in CA, UT, NY, and WA. These data must be submitted
within 18 months of Agency notification of an approved residue analytical method. Also, the section 3 registrants
must provide the gal/A applied in Mobay Report No. 31440. Information on the gal/A applied has been submitted and
is currently under evaluation by the Agency.
14/ Data depicting residues of concern in or on cherries harvested 7 days following the last of three foliar applications
of the 75% WP formulation at 4 Ib ai/A/application. Applications must begin when cherries begin to ripen and must
be repeated at 7-day intervals. The tests must reflect full cover sprays applied using ground equipment and, in
separate tests, aerial sprays in > 5 gal/A. Tests must be conducted in CA, NY, UT, and WA to support the uses
permitted under SLN's CA770034, NY770003, UT790001, and WA770015. The data will also support EPA SLN No. CA770161.
Data must be submitted within 18 months of Agency notification of an approved residue analytical method.
15/ Data depicting residues of concern in or on cherries harvested 7 days following the last of three foliar applications
of the 75% WP formulation at 4 Ib ai/A/application. Applications must be made when cherries begin to ripen and
must be repeated at 7-day intervals. The tests must reflect full cover sprays applied using ground and aerial
equipment, in separate tests, using a minimum of 5 gal/A. Tests must be conducted in CA, NY, UT, and WA (EPA
SLN Nos. CA770034, NY770003, UT790001, and WA770015). Data must be submitted within 18 months of Agency notification
of an approved residue analytical method.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.125 Residue Chemistry Footnotes (continued)
16/ Data depicting residues of concern in or on cherries harvested 3 days after a single foliar application of the
75% WP at 1.5 Ib ai/A using both ground and aerial equipment in separate tests. Ground applications should be
made using 300 ga]/A and aerial applications should be made in a minimum of 5 gal/A. Tests on sweet cherries
must be conducted in WA(37%) and MI(18%), and those on tart cherries must be conducted in MI(77%) and NY(10%)
which produced 48% and 87%, respectively, of the 1984 sweet and tart cherry crops (Agricultural Statistics, 1985,
p. 194). Data must be submitted within 18 months of Agency notification of an approved residue analytical method.
17/ There is an established tolerance for peaches, and the cited data were submitted in support of the tolerance.
However, the adequacy of these data cannot be determined since there are currently no existing Use Directions for
peaches.
18/ The following additional items would be needed to support a crop group tolerance should such a tolerance be sought.
Use directions must be proposed, and appropriate supporting residue data submitted for one additional representative
group member (cranberries). It is noted that tolerances for the following additional crop members of this group
have been proposed: grapes, raspberries, and strawberries.
19/ Because both methods used to collect data are currently being evaluated, data requirements will be contingent
upon the adequacy of the methods. If the Mobay method designated in Report No. 45089 is judged adequate, then
data requirements in 20/ below must be met. If the method in Report No. 25168 is judged adequate, then data
requirements in 21/ below must be met. If neither method is found to be adequate, then data requirements in
22/ below must be met.
20/ The 24(c) registrants must propose reduced use rates, reduced seasonal use rates, and/or an increased PHI and
sutmit appropriate supporting data. Data must be submitted within 18 months of Agency notification of an
approved residue analytical method.
21/ The 24(c) and section 3 registrants must propose reduced use rates, reduced seasonal use rates, and/or an
increased PHI and submit appropriate supporting data. Data must be submitted within 18 months of Agency
notification of an approved residue analytical method.
CJl
LrJ
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.125 Residue Chemistry Footnotes (continued)
22/ Data depicting methiccarb residues of concern in or on blueberries harvested on the day of the last of three
foliar applications of the 75% WP at 2 Ib ai/A. Applications roust be made using ground and aerial equipment, in
separate tests, at treatment intervals of 7 days. An adequate residue analytical method must be used. Tests must
be conducted in AR, IN, NH, NY, OR, PA, VT, and WA to support appropriate SLN registrations. Data must be submitted
within 18 months of Agency notification of an approved residue anlytical method.
23/ The following additional items would be needed to support a crop group tolerance should such a tolerance be
sought. Use directions must be proposed, and appropriate supporting residue data submitted, for additional
representative group members (sorghum and wheat). It is noted that a tolerance for rice grain has been proposed.
24/ Because both methods used to collect data are currently being evaluated, data requirements will be contingent,
in part upon the adequacy of the methods. If the method designated in Report No. 45089 is judged adequate,
data requirement in 25/ below must be met. If the method in Report No. 25168 or neither method is deemed
adequate, data requirement in 26/ below must be met.
25/ Data depicting adequate recovery of methiccarb residues of concern from corn grain fortified at 0.03 ppm, using
the method in Report No. 45089. Data must be submitted within 18 months of Agency notification of an approved
residue analytical method.
26/ Data depicting methiccarb residues of concern in or on corn grain (field and popcorn) and fresh corn (including
sweet corn kernels and cobs) harvested after the following application schedule: seed treatment with a D >
formulation at 0.5 Ib ai/100 Ib seed; and one broadcast application per season of a WP formulation at 0.1 Ib
ai/20 Ib. cracked corn (carrier)/A. Tests must reflect an 80-day PHI. Tests must be conducted in DE, IN, MD, MI,
NY, OH, PA, VA, and WV (where bait uses are registered). All residue data must be collected using an adequate
analytical method. Data must be submitted within 18 months of Agency notification of an approved residue
analytical method.
27/ If the method in Report No. 45089 is deemed adequate, no processing studies are required. However, if the method
is deemed ^inadequate, the field trails requested in 26/ should include exaggerated rates (10 to 25X). If no
measurable residues occur at exaggerated rates, no processing data will be required. Data must be submitted
within 24 months of Agency notification of an approved residue analytical method.
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TABLE A
GENERIC DATA REQUIREMENTS FDR METHIOCAFB
§158.125 Residue Chemistry Footnotes (continued)
28/ The following additional items would be needed to support a crop group tolerance should such a tolerance be
sought. Use directions must be proposed and appropriate supporting residue data submitted for additional
representative group members (wheat and one additional cereal grain). It is noted that a tolerance for rice
straw has been proposed.
29/ Data depicting methiocarb residues of concern in or on corn forage and fodder, harvested after the following
application schedule: seed treatment with a D formulation at 0.5 Ib ai/100 Ib seed and one broadcast application
per season of a WP formulation at 0.1 Ib ai/20 Ib cracked corn (carrier)/A. Fodder samples must reflect an 80-day
PHI and forage samples must be collected at intervals following the bait application or at a pregrazing interval
to be proposed by the registrant. Residue data must be collected using an adeguate analytical method which has
been validated to 0.03 ppm. Tests must be conducted in DE, IN, MD, MI, NY, OH, PA, VA, and WV (where bait uses
are registered). Data must be submitted within 18 months of Agency notification of an approved residue
analytical method.
C7I
30/ There are no tolerances established for these commodities. Because there are numerous data gaps concerning the
magnitude of the residue in feed items of animals, as well as the nature of the residue in animals, no determination
may be made at the time regarding the adequacy of the available data nor the need for the establishment of
tolerances for these commodities.
31/ Residue data and specification of the intended fruit tree crops must be provided to support the current registered
use on non-bearing deciduous fruit trees (trees which will not bear fruit within 1 year of application). Refer to
171-12(d) regarding food use/non-food use determination for non-bearing crop use. All residue data must be
collected using an adeguate analytical method. Data must be submitted within 18 months of Agency notification of
an approved residue analytical method.
32/ Tolerance proposals and supportive residue data are required to support the uses on pepper and sunflower crops
grown for seed. All residue data must be collected using an adequate analytical method. Data must be submitted
within 18 months of Agency notification of an approved residue analytical method.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCAPB
§158.125 Residue Chemistry Footnotes (continued)
33/ Tolerance proposal and supportive data are required to support current use on avocadoes. The current use on this
crop is a soil application with a restriction not to allow formulation to come in contact with edible portions of
plants. All residue data must be collected using an adequate analytical method. Data must be submitted within
18 months of Agency notification of an approved residue analytical method.
34/ The agricultural crops must be specified. Tolerance proposals and supportive data are required to support those
crops for which no methiocarb tolerances exist. The current use is a 24(c) for use in Oregon only. All residue
data gathered must be collected using an adequate analytical method. Data must be submitted within 18 months of
an approved residue analytical method.
en
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCAPB
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be Submitted? for
Submission I/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
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
Adsorption/
Desorption
163-2 - Volatility
(Lab)
TGAI or PAIRA A,B,F,H No
TGAI or PAIRA A,B,F No
TGAI or PAIRA A No
TGAI or PAIRA No
TGAI or PAIRA A,B,F,H No
TGAI or PAIRA A No
TGAI or PAIRA No
TGAI or PAIRA No
TGAI or PAIRA A,B,F Partially 5/ 00145802
TEP
No
Yes
Yes
Yes
No 3/
Yes
Yes
No _4/
No 4/
Yes
No 3/
9 Months
May 1987 2/
May 1987 2/
27 Months
27 Months
August 1987 2/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Time frame
Data Be Submitted? for j
Submission
§158.130 Environmental Fate (continued)
163-3 - Volatility TEP
(Field)
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Agaatic
(Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil,
Long-Term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
TEP
TEP
TEP
TEP
TEP
A,B,H
PAIRA A
TEP
No
No
No
No
No
No
.No
Partially
GS0577004
GS0577005
No 3/
Yes
No 4_/
No 4_/
No 6/
Reserved 7/
Yes
Reserved 8/
November 1988 2/
en
CO
November 1989 2/
165-3 - Irrigated Crops
TEP
No
-No 4_/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Use
Patterns
Does
Have
EPA
Data?
Bibliographic
Citation
Must
Data
Additional
Be Submitted?
Timeframe
for
Submission
V
§158.130 Environmental Fate (continued)
165-4 - In Fish TGAI or PAIRA A,B
165-5 - In Aquatic TEP
Nontarget
Organisms
No
No
Yes
No 4/
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.130 Environmental Fate Footnotes (continued)
I/ Due dates refer to the number of months following issuance of the Registration Standard, unless otherwise
indicated.
2: / These data requirements were previously imposed as part of the Agency's Call-in Notice of August 1986. Therefore,
these sutmittal due dates reflect the timeframes imposed in that Call-in Notice.
V Not required based on the low vapor pressure of methiccarb.
4_/ The 162-4 and 165-3 data requirements were imposed under the Agency's Data Call-in Notice of August 1986. It has
subsequently been determined that they (as well as the 162-3, 164-2, 164-3 and 165-5) are not required
becau the current registered uses do not include any aquatic, forestry, or aquatic impact use sites.
5_/ This study (MRID No. 00145802) is acceptable to fulfill the data requirement for the parent compound for one
soil type only.
6/ Tank mix data requirements are not being imposed by this Standard.
7/ Soi-l long-term study is reserved pending the results of aerobic soil metabolism and field dissipation studies. ON
~ . O
8/ Additional data requirements are reserved pending results of the confined data required under 165-1.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.
Data Requirement
135 Toxicology
Test
Substance
Use Does EPA
Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data Be Submitted? for
Submission l/:
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
—
A,B,F,H Yes
A,B,F,H Yes
A,B,F,H No
— Yes 2/
00036477, 00083437 No
00036478 No
Yes 6 Months _^
-- No
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding -
Rodent
Non-rodent
- 30-Day Feeding -
Non-rodent ( Dog )
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation
- 90-Day Neurotoxicity
TGAI
TGAI
Methiocarb
Sulfoxide
TGAI
— ..
—
—
A No
A No
A,B,F,H No
A,B,F,H No
— No
— No
— No
No 3/
No 3/
Yes 7/ 6 Months
(approved
protocol) .
Yes 6 Months
No 4/
No 5/
No 6/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.
Data Requirement
135 Toxicology (continued)
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic Must Additional Timeframe
Citation Data Be Submitted? for
Submission I/
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity -
Rodent
Nonrodent
- Oncogenicity Study -
Rat
Mouse
- Teratogenicity -
Rat
Rabbit
- Reproduction -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A,B,F,H
A,B,F,H
A,B,F,H
Yes
Yes
Yes
No
Yes
Yes
No
00115226 No
00128939, No
00149362
00115226 No
Yes 8/ 50 Months
ON
00124617 No fV>
00143213 No
Yes 39 Months
MUTAGENICITY TESTING
84-2
84-2
84-2
- Gene Mutation
- Chromosome Aberration
- Other Mechanisms of
TGAI
TGAI
TGAI
A,B,F,H
A,B,F,H
A,B,F,H
No
No
No
*
Yes 9 Months
Yes 12 Months
Yes 12 Months
Mutagenicity
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be Submitted? for
Submission I/
§158.135 Toxicology (continued)
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety 5/
85-3 - Dermal Absorption 5/
PAIRA
No
Yes
24 Months
ON
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.135 Toxicology Footnotes (continued)
V Due dates refer to the number of months following issuance of the Registration Standard, unless otherwise
indicated.
2/ Not required because methiocarb is not an organophosphate. Nonetheless, there is an adequate study available
(MRID No. 83438) which is negative for acute delayed neurotoxicity.
_3/ 90-day feeding studies are not being required because there are adequate chronic studies available.
4/ Not required because existing use-patterns as described in this document do not result in repeated skin
contact for an extended period of time.
V These data are not required for the current use patterns.
_ps
6/ Not required because methiocarb is not an organophosphate.
7/ No effect levels and lowest effect levels for plasma, erythrocyte, and brain cholinesterase inhibition must be
determined. The protocol must be submitted for evaluation prior to initiation of the study. The study must be
submitted within 18 months of acceptance of the protocol by the Agency.
8/ Registrants who conduct chronic feeding and/or oncogenicity studies should inform the Agency in writing of the
dosage levels planned and their reasons for believing that the highest dose approaches or equals the Maximum
Tolerctted Dose observed in subchronic or range finding studies, and must also consult with the Agency to determine
that the appropriate dosage levels are being used in the chronic feeding and/or oncogenicity studies. If EPA
subsequently determines that the study was conducted using a dosage rate that was too low to assess long-term
effects, the study may be deemed not to satisfy the data requirement.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data Be Submitted? for I/
Submission
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP A,B,F No
132-2 - Soil Dissipation TEP A,B,F No
133-3 - Dermal Exposure TEP- A,B,F No
133-4 - Inhalation Exposure TEP A,B,F No
Yes December, 1987
Yes December, 1987
Yes December, 1987
Yes December, 1987
I/ Methiocarb was subject to a special call-in notice for reentry data dated May 27, 1986. These due dates reflect
the time frames imposed in that call-in notice.
Ul
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be Submitted? for
Submission I/
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Acute Oral TGAI
Toxicity
71-2 - Avian Subacute Dietary
A. Upland Game Bird TGAI
B. Waterfowl TGAI
71-3 - Wild Mammal Toxic ity TGAI
71-4 - Avian reproduction
A. Upland Game Bird TGAI
B. Waterfowl TGAI
71-5 - Simulated or Actual TEP
Field Testing for
Mammals and Birds
A,B,F,H Yes
A,B,H
A,B,F,H
A,B
A,B,H
A,B,H
A,B,H
Yes
Yes
No
Yes
Yes
No
GS0577006
00022923
00022923
00128119
00128119
No
No
No
No 2/
No
No
ON
Yes V 6 Months
(Acceptable Pro-
tocol)
70-1 - Special Test, Avian
Repellency
TGAI
A,B,H
No
Yes V April, 1988 ll/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data Be Submitted? for
Submission I/
§158.145 Wildlife and Aquatic Organisms (continued)
AQUATIC ORGANISMS TESTING
72-1 - Freshwater Fish Toxic ity
A. Warmwater TGAI A,B,H Yes 00150628
TEP A,B,H Yes 10/
B. Coldwater TGAI A,B,F,H Yes 00150628
TEP A,B,F,H Yes 10/
No
No
No
No
72-2 - Acute Toxicity to TGAI
Aquatic Invertebrates
72-3 - Acute Toxic ity to Estuarine
and Marine Organisms
Fish
Shrimp
Oysters
72-4 - Fish and Early Life-Stage
and Aquatic Invertebrate
Life Cycle
Fish
Invertebrates
72-5 - Fish Life Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual TEP
Field Testing for
Aquatic Organisms
A,B,F,H Yes
00127638
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
NO
No
NO
Partial
No
No
No
00155967
A,B
No
No
Yes 5_/
Yes 5_/
Yes 5/
ON
August 1987 ll/
August 1987 ll/
August 1987 ll/
Yes j6/ November 1987 ll/
Yes November 1987 ll/
Reserved 7/
No 2_/
Reserved 8/
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be Submitted? for
Submissionl/
70-1 - Special Test, Aquatic
Residue Monitoring
TEP
A,B
.No
Yes 9/ April 1988 ll/
CO
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.145 Wildlife and Aquatic Organisms Footnotes
V Due dates refer to the number of months following issuance of the Registration Standard, unless otherwise
specified.
2/ Not currently a requirement.
'' Terrestrial field studies as described below will be required to support registered uses of methiocarb.
To support registration of granular and pelletized bait products; A study must be conducted using the 2%
granular bait formulation at the maximum label rate (0.94 ai/A) and the maximum number of minimally spaced
repeat applications. The purpose of this study will be to determine whether the use of these products could
result in wildlife kills. Studies conducted at maximum application rates on citrus in California using ground
equipment or as a preplant soil application in Oregon using aerial equipment would be acceptable. Seven treat-
ment fields and a control field should be selected for study. Treatment fields should be at least 50 acres in
size. The study will require 1 year of observations. A 3- to 4-month pretreatment period of baseline observa-
tions should be included in the study design. During the baseline study period, observations of the abundance
and distribution of bids and all other nontarget species within the study areas should be recorded, during the
treatment period, methiocarb must be applied using the maximum number of minimally-spaced repeat applications.
Posttreatment mortality and toxic symptoms among all nontarget species must be observed and recorded. Blood,
brain, and carcass analysis for residues and cholinesterase inhibition should be conducted. Soil, vegetation,
and nontarget insects should be monitored for methiocarb residues. Carcass search efficiency must also be
determined and documented. A study protocol must be submitted for review prior to initiation of the study.
To support registration of methiocarb dust, and corn treatment and cracked corn bait, and other methiocarb seed
treatments; A field study to determine the wildlife population reduction hazard from the use of cracked corn
treated with methiocarb as a molluscide is required. This study must also be conducted to support the use of
methiocarb seed corn treatment and other seed treatments used to repel birds. A primary objective of this
study will be to determine the hazard to birds from the use of methiocarb cracked corn mollusicide and seed
treatment to repel birds. The study will require the selection of a study site typical of corn-growing regions
(i.e., Illinois or Iowa). Within the geographical site at least two treatment plots and two control plots
should be selected for study. These plots should be at least 150 acres in size. The study will require 2
years of observations. During the first year, baseline observations should include observation of the abundance
and distribution of birds and other nontarget organisms present within the study areas. All test sites (biotic
and abiotic components) should be screened for pesticide residues during the first year of the study. No
methiocarb should be applied during the first year. During the second year, methiocarb cracked corn slug bait
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.145 Wildlife and Aquatic Organisms Footnotes (continued)
should be used at the maximum rate (0.1 lb/10 Ib cracked corn/A), with the maximum number of minimally-spaced
repeat applications. Observations of the abundance and distribution of all nontarget species within the study
areas should be recorded. Blood, brain, and carcass analysis for residues and cholinesterase inhibition should
be conducted. Birds and nontarget species exhibiting toxic sublethal symptoms should be sampled and monitored
for continued toxic symptoms, eventual recovery or death, and pesticide residues, as well as cholinesterase
inhibition. Soil, vegetation, nontarget insects, and water should be monitored for residues resulting from
application of methiocarb. Carcass search efficiency must also be determined and documented. A protocol must
be submitted for review prior to study initiation.
To support registration of methiocarb 75% WP (all uses). A field study will be required to support all uses
of methiocarb 75% wettable powder. The purpose of this study will be to measure wildlife mortality associated
with the use of methiocarb 75% wettable powder as an avian repellent and insecticide. Studies conducted at the
maximum application rate (4.0 Ib ai/acre) on blueberries and cherries would be acceptable. Two geographically
different sites should be selected and cherry-growing sites in the States of California and Michigan should be
selected. At each geographic site, seven treatment plots and a control plot of at least 50 acres in six should
be selected. The study will require 1 year of observation. A 3 to 4 month pretreatment period of baseline
observation should be included in the study design. During the baseline study period, observations of the
abundance and distribution of birds and all other nontarget species within the study areas should be recorded.
During the treatment period, methiocarb must be applied using the maximum number of minimally-spaced repeat
applications. Posttreatment mortality and toxic symptoms among all nontarget species must be observed and
recorded. Blood, brain, and carcass analysis for residues and cholinesterase inhibition should be conducted.
Soil, vegetation, and nontarget insects should be monitored for methiocarb residues. Carcass search efficiency
must also be determined and documented. A study protocol must be submitted for review prior to initiation of >
the study.
V Avian repellency studies should be conducted according to ASTM guidelines for comparative acute and long-term
oral or gustatory avian repellency studies (ASTM Designation E657-78). A protocol for this study has been
received and is currently under evaluation by the Agency.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.145 Wildlife and Aquatic Organisms Footnotes (continued)
5_/ Required to support the use of this product on corn, turf, fruit crops, and other uses associated with coastal
counties.
6/ The study partially fulfills the requirement. If data describing water temperatures in each test tank are submitted
and show that no significant variance in temperature occurred in any of the tanks, the study may be upgraded.
7/ A requirement for this study is reserved pending the results of the fish early life stage study.
8/ Requirements for aquatic field studies are reserved pending the results of aquatic residue monitoring studies.
9/ Residue data on methiocarb and its major metabolites are required in order to determine exposure levels in
receiving waters adjacent to use sites. Residues in water resulting from the use of granular or pelletized
baits, treated corn and seeds, and the 75% wettable powder must be described. These studies could be conducted
simultaneously with the terrestrial field studies cited in footnote 3 required to support each use. Residue
monitoring studies must incorporate the following design characteristics: 1) The percentage of the drainage
area under treatment should be provided. Topographical maps showing the relationship of the sampling sites to
untreated areas within each watershed should be specified. 2) Soil characteristics of the fields being monitored J
should be specified. 3) Analytical methodology used to measure the residues of methiocarb must be given. The *
chemical detection of residues must be quantified by the most sensitive methodology available. 4) In addition
to water samples, the hydrosoil (top 0.5 inch only) must be sampled at all stations. 5) Sampling stations at
each site should-be located in adjacent bodies of water (i.e., drainage ditches, waterways, and canals).
Runoff from fields should also be measured. A protocol for this study has been received and is currently
under evaluation by the Agency.
10/ Though the available studies(MRID No. 00036484) have been found to be acceptable, they are not required to
support continued registration of the current uses of methiocarb because a) methiocarb is not registered for
direct application to water, and b) aquatic residues resulting from the registered uses are not expected to
exceed the acute toxicity level of the technical material to fish.
ll/ These data requirements were previously imposed as part of the Agency's Call-in Notice of August 1986. Therefore,
these submittal due dates reflect the timeframes imposed in that Call-in Notice.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be Submitted?
§158.155 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS;
141-1 - Honeybee Acute
Contact Toxicity
141-2 - Honeybee - Toxicity
of Residues on
Foliage
TGAI
TEP
141-4 - Honeybee Subacute
Feeding Study
141-5 - Field Testing
for Pollinators
Reserved I/
TEP
NONTARGET INSECT TESTING - AQUATIC INSTECTS;
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect
Life Cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
143-1 - NONTARGET INSECT TESTING-
thru PREDATORS AND PARASITES
143-3
Reserved 3/
Reserved 3/
Reserved 3/
Reserved 3/
A,B
A,B
A,B
Yes
Yes
00036935
00060625
No
No
ro
No
No 2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIOCARB
§158.155 Nontarget Insect Footnotes
V Reserved pending development of test methodology.
2/ This data requirement is imposed only on a case-by-case basis. Data reviewed under the Standard do not indicate the
need for a field study.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHIOCARB
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? I/ Citation I/
Must Additional Timeframe
Data Be Submitted? for
Submission 2/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity MP
and Disclosure
of Ingredients
61-2 - Description of MP
Beginning
Materials and
Manufacturing
Process
61-3 - Discussion of MP
Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary MP
Analysis
62-2 - Certification MP
of Limits
62-3 - Analytical Methods - MP
to Verify Certified
Limit
All
All
Yes
Yes
All
Yes
All
All
All
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHIOCARB
Data Requirement
Test
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data? Citation V Data Be Submitted? for
Submission 2/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
- Color
- Physical State
- Odor
- Density, Bulk
Density, or
Specific Gravity
- pH
- Oxidizing or
Reducing Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
All
All
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
.Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months . <-n
6 Months
6 Months'
15 Months
6 Months
6 Months
15 Months
Characteristics
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHIOCARB
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation I/
Must Additional
Data Be Submitted?
Timeframe
for 2/
Submission
§158.120 Product Chemistry (continued)
Other Requirements;
64-1 - Submittal of Samples MP
All
Reserved 3/
V Although product chemistry data may have been submitted in the past/ the Agency has determined that these data
must be resubmitted for each manufacturing-use product. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
indicated.
3/ If samples are needed, the Agency will request them.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHIOCARB
§158.
ACUTE
81-1
81-2
81-3
31-4
81-5
81-6
Data Requirement
135 Toxicology
TESTING:
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Test
Substance
MP
MP
MP
MP
MP
MP
Does EPA Bibliographic Must Additional
Have Data?!/ Citation Data Be Submitted?
Yes 3/
Yes 3/
Yes
Yes
Yes
Yes
Timeframe
for
Submission 2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Guinea Pig
I/ Although product specific toxicity data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each manufacturing-use product.
2/ Due dates refer to the number of months following issuance of this Registration Standard.
3/ If the MP is a technical grade active ingredient, refer to the Toxicology Table A for data requirements which
may have been satisfied.
-------
78
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel/ preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address/ or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g./ "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, "net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label/ preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)J
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR I62.10(g)]
-------
79
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations/ the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.lO(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i )]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.lO(h)(l)(iii)l
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h ) (2 ) ] .
-------
80
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR I62.10(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)(iiJ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-------
81
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All.uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h).(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
.in Section I). If use is restricted to certified applicators/
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not-all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
82
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the .producer, must
be qualified by "Packed for . . . , "
"Distributed by., . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
CD
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
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
C
-1
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
. Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
" 150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by^ the Agency
All products
All products
PLACEMENT CM LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Imnediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
oo
Ul
-------
©'
.
I
m
PIUCAUTQXAflY STATEMENTS
HAJAflOS 10 HUMANS
II DOUfStC AW1MAISI
OANOf«
rut/wtojLir N t Ai M47Aftn*
i
RESTRICTED USE I
PESTICIDE 4©
. for rtttll til' to and wit »«ilr »r Cortuitd Appllcilori 1
or ftriaii vitdtr t*«tlr dlritl iupir«lila* fd only for I
Ihotf »t»« co«»r»< by tht CirtUIrd Appllcttort Ctrtlfl- I
tltlon, . • 1
CROP •
00
«t
STORAGE AND
DISPOSAL
cnrv _
PRODUCT
NAME
ACTIVE MORETCNT . %
HT-RT MOMEDCNTS ____________ t
TOTAt 1OOOO«
ms PRODUCT CONTAM9 1*9 Of PEH OA1XON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
act see
~l&
rcm AoomcmAi P«CAIITONAHT STATEMENTS
TOWN, sS ATE "
5ft(STABt.l$HMENT NO =
EPA nertisTHAtio*! NO
NET CONTENTS:
••—^
6i
s^^
©
©
CROP:
WAMUMTY STATEMENT
OO
ON
-------
rn| c MilO'MOi JMHUI
.,«/.noS IO IHIM«»$
il IXK'ISIC »»ui|Si
C AIM ION
on C"(uCM
ci
to «M
n( ( xin«
II >r
't Nl
5TORAGE AMD
DISPOSAL
PRODUCT
NAME
»Cl(vt
IOIM
tins rnuouct COMIAMS ins fx rinn*no»i
KEEP OUT OF REACH OF CI IILDREN
CAUTION
StAtfUCiM Of rn»ric»» I "I • I MI ill
• untie n
f OS S«H
f ffl f T| S
*pniic'«nr
n»
s'»n«iS'«M|wi NO =
Nil CONIfHl?:
?A
cnor
Cno"
COOP
CO
-------
Chapter I—Environmental fVotodicn Agency
§ 162.70
5ant obtained the data Jrom anoihe
(identify); applicant .copied da*
frbm a publication: applicant obtained
a ippy of the data from EPA).
(a) The applicant shall submit j/ith
his application a statement that SPA.
In Iti evaluation of the properties/effi-
cacyAand safety of the fonnyuated
end-uie product, may not consider any
data its supporting the application.
except the following data:
(1) The data the applicant has sub-
mitted u EPA under paragraph (b) of
this section:
(2) Other data pertaining to the
safety of we product's actwe ingredi-
ents, rather than to the sqnety of the
end-use procuct: and
(3) Existink tolerances, food additive
regulations. Vexemptions/ and other
clearances Issued underf the Federal
Food. Drug, and Cosmetic Act.
(e) If the applicant Knows that any
item of data hf payment of
any compensation that\may be pay-
able under FOTflA section
3 product con-
LaiVs any active InRTedient ott-.er than
those that are present solely becadse
of thV Incorpcraticn Into the product,
durink formulation, of one or/more
other Vegistered pesticide products
purcbHSbd from another p/oducer.
then the\appllcant shall ols^ comply
with } 162*^-5 as to such ac/ive Ingre-
dient. andVne application/shall con-
tain an acknowledgment that for pur-
poses of FTFliA section 3e regarded as
if It were based ui the/Administrator's
consideration of )\he/ollowlng data:
(1) All data submitted or specifically
cited by the appu/qant in support of
the registration; i
(2) Each othec'itei
Agency's files wtiich:
(I) Concerns line pr
of any such active :
(11) Is one hi the types Vf data that
EPA would/equire to be submitted for
scientific review by EPA lAthe appli-
cant sought the initial registration
under PIFRA Section 3(cX6) of a
product/with composition andMntend-
ed use/ identical to those proposed for
the iippUcant's product, unde
data/requirements in effect onthe
EPA approves the applicant's
prsent application.
. 3. 8. and 3S of FIFRA. aa amended.^
. 136et«e«.>
(44 FR 27953. May 11.1979)
6 162.10 Labciinc requirement*.
(a) General—U) 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 »how clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion:
(11) The name and address of the
producer, registrant.. or person for
whom produced as prescribed in para-
graph (c) of this section:
(ill) The net contents as prescribed
In paragraph (d) of this section:
-------
§ 162.10
(Iv) The product registration
number as prescribed In paragraph (e)
of this section:
(v) The producing establishment
number as prescribed In paragraph (f)
of this section:
(vl) An Ingredient statement as pre-
scribed In paragraph Claims as to the safety of the
pesticide or Its Ingredients. Incluc Ing
statements such as "safe," "nonpolson-
ous." "nonlnjurlous." "harmless" or
"nontoxlc to humans and peU" with
or without such a qualifying phrase as
"when used an directed"; and
(x> Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
.
§ 167.10
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the Inhel shall he con
sldered as the name and address of (he
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 (he 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 mrnjrurr nf con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall t»»
the average content unless explicitly'
stated as a minimum quantity.
(2) If the pesticide Is a liquid. t.he
net content statement shall be In
terms of liquid measure at ««' F (20'C>
and shall be expressed In conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide Is solid or semlsn-
lld. viscous or pressurized, or Is a mix-
ture of liquid and solid, the net con-
tent statement shall be In terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall he
* stated In terms of the largest miltable
units. I.e.. "1 pound 10 ounces" rather
than "26 ounces."
(8) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(0) Variation above minimum con-
tent 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 In 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 regiitratian number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set In type of a sice and style similar to
other print on that part of the label
on which It appears and shall run par-
OO
-------
§ 167.10
sllet to It. The registration number
and the required Identifying phrase
shall not appear In such a manner u
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishment* regia-
(radon number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear In any
suI table location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient ttatement—{l) Gener-
al The label of each pesticide product
mu.it bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "Active Ingredi-
ents" and the Inert Ingredients by the
term "Inert Ingredients." or the singu-
lar lorms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent The
statement "Inert Ingredients, none" ls
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the Ingredient statement Is a
complete analysts of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of Ingredient statement
(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
rend, the Ingredient statement must
also appear on such outside container
or wrapper. If the slr,e or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
Till*
»f Invlr»nm«nt
(II) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Name* to be used In ingredient
statement. The name used for each In-
gredient shall be the accepted
common name. It there to 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, the chemical
name alone shall be used. In no CUM
will the use of a trademark or propri-
etary name be permitted unless* such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cX6).
(4) Statement* of percentage*. The
percentages of Ingredients shall be
stated In terms of welght-to-wetght
The sum of percentages of the active
and the Inert Ingredient* shall be 100.
Percentages shall no't be expressed by
a range of values such as "32-25%.' If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the Ingredient
statement
(6) Accuracy of tinted percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
[date)."
(II) The product must meet alt label
claims up to the expiration time Indi-
cated on the label.
(7) /ner£ ingredients. The Adminis-
trator may require the name of any
Chapter I—Environmental Protection Agency
$ 162.10
Inert Ingredlent(s) to be listed In the
Ingredient statement If he determines
that such IngredlenUs) may pose a
hazard to man or the envlronmcn*.
(h> Warning! and prrcotiM* nary
statements. Required warnings and
precautionary statements concr nlng
the general areas of loxlcott glcal
hazard Including hazard to chit Iren.
environmental hazard, and physic at or
chemical hazard fall Into two groups;
those required on the' front panel of
the labeling and those which may
appear elsewhere. RpeelHr require-
ments concerning content, placement.
type sfr.e. and prominence are irlvrn
below.
(1) Required front nnnrl utalrmrnt*.
With the exception, of Ihr rhlld
hazard warning statement. Ihr text re-
quired on the front panel of Ihr label
In determined by the Toxlrlly Catego-
ry of the pesticide. The category Is as-
Signed on the basin of (he highest
hazard shown by any of the inrllmtors
In the table below:
Hmr
On* U>.
MmMtai 1C- .
Own* 10»
SMidMcH
Up « ml hdurfkig m
Ut> to Ml Mdudtag »
mglta.
mg/kg
CorratlM-. «n
fJOCCMy *^l rw^wWii
Prom M> (hni 900 fng/kQ
Ffom y ttvu f mo/Dor...
rtem no ihni MOO
*«o»*tr»
From WO Ifcru Win mg/
'•
Frem ?. Ihru 90 mg/Ww
From J.OOO Urn JO.OOO.
Mo co"i*ol ooocMy:
Mtanon fOww^JN.
"9
rv
tvwan wm «»^'
?n
(I) Human ftozanf signal word—I At
ToTicitv Category I. All pesticide prod-
ucts meeting the criteria of Toxlclty
Category I shall bear on, the front
panel the signal word "Danger." In ad-
dition If the product was assigned to
Toxlclty Category I on the basis of Its
oral. Inhalation or dermal toxlclty (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) Toxicitv Category II. All pesti-
cide products meeting the criteria of
Toxlclty Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicltv Category III. All pesti-
cide products meeting the criteria of
Toxlclty Category HI shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxtcitv Category IV. All pesti-
cide products meeting the criteria of
Toxlclty Category IV shall beer on the
front panel the signal word "Caution."
(R) U.if of signal word!. Use of any
signal word(s) associated with a higher
Toxlclty Category Is not permitted
except when the Agency determines
that such labeling Is necessary to pre
vent unreasonable adverse efferl.1 on
man or the environment. In no rase
shall more than one. human hazard
signal word appear on the front panel
of a label.
(II) Child hatard warning. Kvery pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only In rases
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.
(ill) Statement of practical trtal-
merit—(A) Toxicltv Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides full-
Ing Into Toxlclty Category I on the
basis of oral. Inhalation or dermal tox-
lclty. The Agency may. howover,
permit reasonable variations In (he
placement of the stal.emrnl nf prartl-
CD
-------
§ U7.10
cnl treatment Is some reference such
M "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 not
required on the front panel except as
described In paragraph (h Hi Mill MA) of
this section. The applicant may. how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label In
accord with paragraph *. en Hdn, er en cMNnrj
he ritri I V^VOVMO [Muled or Aeorbod
»r«un>< tie «*<). Oo not breofte •». O" nan, or on
MarrnM i jnHu.*!) (MiiUf) or ebtorbed vnuori «•
->-i A«okf nrMOtoQ •««»» (duel er em« "*"1
- (Apero-
prOM DrM Hd mt^nnl raoj»ed ).
il. Oo not frt h etree. en ekkv er
k WMT oogo^e er kjee erMW^en) Mt
en
Mbber
or Met • etn*r««l
(A*.
«TM «d eMement(equtodl
•Ml ^ttL •*•• tV dBrtrJjVA. fcl ^H>ff Of
eMMr *Mh efee « •»> «Oi punr, oi
IUM.1
(II) Environmental haitants. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Examples of the
hazard statements and the circum-
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 to* 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.
(O If a pesticide Intended for out-
door use contains an active Ingredient
with an avlan acute oral LDM of 100
mg/kg or less, or a subncule dietary
LCM of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that uxe of the
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide Is extremely toxic »o ,
wildlife (fish)" Is required.
(R> For uses Involving foliar applica-
tion to agricultural crops, forest*, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic lo
pollinating Insect* 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. On not rnnlamlnaio
water by cleaning of equipment or dis-
posal of wastes."
(Ill) rhynical or rhernicat harartts.
Warning statements on the flRmmnhll
Ity or explosive characteristics of ihf
pesticide are required as follows:
(A) Pmtstmrto
n«n peM M or brioo JO" F; • ton h • Itonhic* >l
FlMh noMitaM W r «nd not o>»> «V F or • th.
of 8 hi from Ifw florm.
Fi»«v lnr*np**)l*
lo lMnfwrati*T»« ahfrwo 'lo' r *»*»v '••»«•
EMpOwUrtt IQ l«rffp«r»hw« «bO*« 110' F *n*>v CMi-** htjuttnrj
AXK*. 00 not pundw 9 Incitvmibi contBlrw. Ferwvwsr* in
. MffvmMw tbow* 130* F nwy CMIM bur^imq
(B)
Abo** w t end not ow KT r
Aboo* XT f *nd not OMT ISO* F
*WtM*«.
Oo net UM or nor* n*v hMt or on-m fi.mw
(I) rXrection* /or U»e—(1) General
fTVttirrment*—(I) Adequacy and clar-
ity o/ direction*. Directions for use
must be stated In terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal Injury and to prevent
unreasonable advene effects on the
environment.
(II) Placement of direction* for ute.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pestlcfo'e product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
-------
§ U2.10
(/) The label clearly showa that the
product Is Intended for use only In
manufacturing processes and specifies
the lype [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
Pr©9oeO!en
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.
(F) 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. 1076. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (JXI) and (2) of this sec-
lion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted use(s)
except that. If a product has both re-
stricted usn(s) and general use(s). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of 5 182.IO(JK2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "Oeneral
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 Direction!) for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Vae Classification,
Pesticide products bearing direction
for use
may be. Staling that theVippllnant or
registrant/has the opportunity to
submit evidence In rebutUJ of such
presumption In accordance ^llh para-
graph i^X<3) of this section, "roe appli-
cant jp registrant shall have ftfrty-flve
(48)>9ays from the date such nralw is
sen/ to submit evldenee In rebuthal of
tha prenumptlon; provided,
lat for good cause shown the Admin-
fstrator may grant an additional sl
notice of
pursuant
Art. or a
ro
-------
93
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A* Flashpoint at or below
20°F; or if there is .a
flashback at any .valve
opening.
B. Flashpoint above 20*F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80 °F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture 'or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
94
STOR-l
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
95
PEST/DIS-l
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."
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96
CONT/DIS-l
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
( bags )
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Glass containers
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment, then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused*, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
EPrt index' to Pfest icide 'Chemicals
4-(NETHYLlH10)-3,5-XYLYL METHYLCftRBfiMftTE
TflBLE OF CONTENTS
Site Name Page
Agricultural Crops £
Avocado iE:
Blueberry 3
Cherry A
Citrus Fruits £
Citrus Fruits (nonDearing) 5
Corn (grown for decorative purposes) . 8
Corn (including field, sweet, and popcorn) 6
Crucifers (grown for seed) 7
Deciduous Fruit 7rees (nonbearing) 5
Dichondra 9
Ginseng 7
Ornamental Flowering Plants . S
Ornamental Ground Cover 9
Ornamental Lawns and Turf 9
Ornamental Plants 10
Ornamental Plants 11
Ornamental Plants (tropical ornamentals, nursery
stock) 1O
Ornamental and/or Snaae Trees 9
Ornamental and/or Snade Trees (seed treatment for
nursery stock) 10
Ornamental woody Shrubs 9
Ornamental Wooay Shrubs and vines • 9
Peooers (grown for seed) 7
Sunflower (grown for seed) 8
97
Issued: S-0£-86 111-100501-a ;
-------
EPt-l Inocx to Pesticide Cnemi
clOOiJOi 4-
WP (75%)
wflftMlNGS ftND LIMITATIONS; ftil outdoor uses of methiocaro
(except homeowner uses) are classified as RESTRICTED USE PESTI-
CIDES. Certain t>0 percent dust formulations are RESTRICTED USE
PESTICIDES. #* fi 75 percent wettable powder formulation (Registra-
tion number uO31£5-OO£8fl) is only for agricultural use, or for sale
to, use, ana storage by commercial applicators, and other service
persons. Do not use the & percent granular or pel leted/taaleted
formulations on or around plants grown for food. Do not apply the
75 percent wettable powder formulation with oil.
For the dusts and wettable powder formulations, wear protective
clothing, natural rubber gloves, goggles, and a suitaole masK or
respirator. Do not enter treated fields for £4 hours following
treatment. Consult a State flgricultural Extension Service regard-
ing protective information.
Observe all warnings and limitations for the other active ingredi-
ent on the multiple active ingredient label ana the Si-Ns.
Dosages are given in active ingredient.
Bee Caution; Methiocarb is highly toxic to bees exposed to direct
treatment or residues on blooming crops or weeds. Do not apply
methiocarb or allow it to drift to blooming crops on weeds if bees
are visiting the treatment area.
agricultural Crop Tolerances (other than those listed in the text):
Peaches - 15 ppni
Definition of Terms ;
Fitoi - Multiple active ingredient (s)
&i-N - Special Local Needs C£4(C)D
**Refer to fluxiliary Documentation.
*rnetniocarD (BSI)
3, 5-di methyl-A- (met hy 1th io) Dhenol methyl car barnate
Mesuroi _ _
98
Issued: 5-O£-66 11I-1GG5O1-1
-------
Inoex to Pesticide Ciiernicais
A-(MtTHYLTrilQ)-3, S-
Site anfl Pest
Dosaoes and ToJerar.ce, Use, Li mi tat ions
r ormu 1 at i ori is)
•'DOD CROP
(agricultural £roos..L
Hqricultural Crops
IGDRftCfl
IGDflOBft
Slugs
Snai1s
CSLND
up to O. 8
Ib/fl
(£* G)
/OfcOOlftfl
/OEOOOttR
flvocado
Citrus Fruits
IGDflflBft
Snails
CSLN3
up to O. SA
Ib/ft
(£54 G)
(£>4 P/T)
No tolerance established.
SLN: IH cay preDlant interval
Through 0.8 pouna per sere.
SLN - Use limited to CR.
PreDlant soil application. ftpply
bait uniformly over areas to be
treated by ground equipment or
aircraft. Repeat as needed up to
14 days prior to planting.
O.0£ ppm (citrus fruits)
No tolerance established (avoca-
do) .
SLN: No preharvest interval
through O.94 pound per acre for
soil application.
Do not make more than £ applica-
tions per season. Do not allow
formulation to corne in contact
with edible portions of plants.
SLN - Use limited to CR.
Soil application. Ppply by
ground equipment between rows.
Apoly when needed and repeat &
weeks later.
CSLN3 CMftlD SLN - Use limited to Cft.
O. 38-O.5 Ib/R Soil application. Rpply by
(1% G) ground equipment between rows.
ftpply when foliage and fruit is
relatively dry but soil is wet
following irrigation.
Formulated with rnetaldehyde.
fllso see Citrus Fruits
ing) cluster.
(nonbear-
Issued: 5-O£-86
III-10O501-£
99
-------
EPP Inoex to Pesticide Chemicals
- (M£THYi_THlO> -3. 5-XYL.YL
Site aria Pest
Do sajq e. s__an G Tolerance, Use, Limit at ions
For mui at ion (s)
VIVZPQM
VlVRBBft
VIWBftftft
VIVZBEfl
VIVOBBfl
VIVUftHfl
Bait into re
oriole
Biue jays
Cedar Max
Finches
Crackles
Red Minced
black bird
Robin
Star1 ings
5 pprn (interim)
7 day preharvest interval tnrougn
3.O pounds per acre per season
for foliar application.
SLN! No preharvest interval
through b. 0 oouncis oer ao-^e oer
season for foliar application.
1.5 Ib/ft Use limited to areas other tnan
(75% WP) Ctt. Use expires march 31, iy6B.
003125-00£88 Foliar application. Repellent.
ftpply by ground eauioment or air-
craft in: a rninimurn of ti gallons
per acre. flpply as berries beqin
to ripen and repeat as needed to
maintain repellency with at least
7 days betMeen applications.
CSLN3
1.5-2.0 IP/ft
(75% WP)
SLN - Use limited to ftR, IN, NH,
NY, OR, Pft, VT, and Wfl.
IQBMRPft
Blueberry mag
got (adult)
0.75-1.3 Ib/P Use limited to areas other tnan
(75% WP) Cft. Use expires March 31, 1988.
Foliar application. fipply by
ground equipment or aircraft in a
minimum of 5 gallons per acre.
Ppply in accordance with local
conditions using the higher rate
when population aensities are
high. Repeat at rninimurn 7 day
intervals as needed.
*CSLND SLN - Use limited to fiR, IN, Nh,
O. 75-1.5 Ib/tt NY, Pft, and VT.
(75% WP)
*Refer to Auxiliary Documentation.
Issued: 5-O2-66
I I 1-100501-3
100
-------
EPH inaex to Pesticide Chemicals
4-dv,E"lh.YLTriiO)-3, 5-XYLYL METHYL.CAKBAMMTE
bite ana Pest Dosages ana , Tolerance, Use, Limitations
£ orrriu i at i on (s)
/ 05001=: Art
Cnerry
VIVFBAA
VIVRBBA
VIwBAAA
VIV/ZAGA
VIVOBBA
VIWfciAAA
V1VUAAA
Blue jays
Cedar wax
Finches
GracKles
Robin
Sparrows
Starlinns
1.5 Ip/A
or
O.3 IP/100
pal
(75% WP)
003l£5-00£a8
£.0-4.0 Ib/A
(75% WP)
5 pprn (interim)
14 day preharvest interval
through 3.0 pounds per acre per
season for foliar application.
3 oay preharvest interval through
1.5 pounds per acre for l foliar
application per season.
SLN: 7 day preharvest interval
through 4.0 pounds per acre for
foliar application. Do not make
more than 3 applications per sea-
son. Do not graze or feed cover
crops grown in treated areas.
Use limited to areas other than
CA. Use expires March 31, I9ti8.
Foliar application. Apply by
ground eauiprnent in 300 gallons
per acre or by aircraft in a min-
imum of 5 gallons per acre. Ap-
ply as cherries begin to ripen
and repeat as needed with a mini-
mum of 7 days between applica-
tions.
SLN - Use limited to CA, NY, UT,
and UA.
Foliar application. Repellent.
Apply by ground eduipment as full
coverage spray or by aircraft in
a minimum of 5 gallons per acre.
Apply as cherries begin to ripen.
Use the higher rate for larger or
denser trees or both.
IOBMAL.A
IL.AVASA
ICAVAYA
INASAVA
Cherry fruit
fly
European red
mite
McDaniel spider
rn i t e
Plum curculio
O.75-I.O Ib/A Use limited to areas other than
or CA. Use expires March 31, 1988.
O.£5-O.33 lb/ Foliar application. Apply py
lOO gal ground equipment in 300 gallons
(75% WP) per acre or by aircraft in a min-
imum of 5 gallons per acre. Ap-
ply as needed with a minimum of 7
days between applications.
Issued: 5-O2-86
III-1O05O1-4
01
-------
EPP. Inoex to Pesticiae Cneriiical
4- (mETHVL-THlO) -3, 5-XYLYi_ K
bite ana Pest
Dosages ano Tolerance,
Form u i a 1 1 OKI (s)
us e , i_ i rn i t a 1 1 o n s
(cent inuea)
*CSi_NJ
0. 75-1. 0
1OO gal
Crnax. 400
gai/WD
(75% wP)
- use limited to NY.
ID/ Foliar appl icat ion. (nooly the
hipn rate as an eradicative treat-
ment for heavy pest populations
ana for p!i urn curcuj._io. P^aly tne
low rate in seasonal spray pro-
grams. Repeat as neeaea. ror
cnerry fruit fly and plurn curcu-
i10, consult a State Agricultural
Extension Service regarding the
number and timing of sprays in
seasonal spray programs.
*Refer to Auxiliary Documentation.
/020000ft
C11rus Fruits (nonbearino)
Deciduous Hruit Trees (non-
Dear me)
IRACABA
Pphids
mites
O. OS pprn (citrus fruits)
No tolerance estaDlisned (deci-
duous fruit trees).
ttpply through £>. 0 pounds per acre
per season for foliar applica-
t ion.
Do not make more than 4 apalica-
tions per season.
Uo not apply to trees that will
near fruit within i year of appli-
cat ion.
O. 375-O. 75 Foliar application. ftppiy spray
lb/50 gal/P until thoroughly wet. Repeat as
(75* WP) needed.
OO3 125-00288
IGDAACA
1GDAOBP
Slups
SnaaIs
1.5 lb/50
gal/ft
WP)
Also see ftvocado cluster.
Issued: 5-O£-66
111-100501-5
102
-------
EPft Inoex to Pest i'cide -Lhemicals
4-(METHYi_7Hia;-3, 5-XYLYL r^TKY
S,i_te arid Pest
To 1 erance.,. L'se,_ _ ui nn t at_i_or:&
Formal at ion-(s)
Q.9.TJ2 (including field, sweet,
and poocorn)
VIVZftBft
VKGrtBDft
VIHEBHft
VKGGDGfl
Blackbirds
Mice CSi_N3
Pheasant
Pra i r i e vo1e
ISDftftCft
IGDftftBft
Slugs
Snai1s
O.£5-0.5 lb/
1O,0 lb seea
or
1.5-4.5 oz/bu
(18.75%, 5054
D)
OO3125-OO3O9
or
*1.l£5-6.0
oz/lOO lb
seed
t75* WP)
O07501-00088
CSLND
O. 1 lb/£0 lb
cracked
corn/ft
(SOX'D)
(75* WP)
O. 03 porn (fresn Concluding sweet
(K+CWHR)D)
(fonder)
(forage)
(grain, field)
(grain, poo)
l£O day (5O percent dust) or 80
oay (75 percent wettablet powder)
orenarvest interval througn O. 1
pound per £0 pounds cracked corn
per acre for bait application.
ftpply 1 bait application per sea-
son.
Seea treatment through O. 5 pound
per 10O pounds of seed.
Treated seeds must not be left ex-
posed on soil surface or be used
for food, feed or oil purposes.
The formulations may be ohytotox-
ic to corn under cool, wet grow-
ing conditions.
For seed treatment and bait appli-
cation, refer to appropriate
labeling for Endangered Species
Restrictions.
*RESTRICTED USE PESTICIDE (5O per-
cent dust).
Seed treatment. Repellent. ftp-
ply the dusts to seed in the hop-
per or a container. ftpply the
high rate for pheasants or prai-
rie voles. ftpply the wettaole
powder as a slurry using 1.185 to
£.£5 ounces per hundred pounds
seed for blackPirds and 3.0 ,to
b.0 ounces for pheasants and
prairie voles.
SLN - Use limited to Dt, IN, MD,
MI, NY, GH, Pfl, Vft, and WV.
Bait application. ftpply as a
broadcast application to the soil
surface when snai1 or slug damage
becomes apparent. The crackea
corn may be moistened for applica-
tion of the wettable powder.
Issued: 5-OS-86
*Refer to Auxiliary Documentation
103
111-1OO501-6
-------
E-'M Inoex to Pesticioe Chemicals
4- (PitTHYLTHiO) -3, 5-XYu.YL f>El H.YLCRRBRMRTE
bite ana Pest
Dosages ane Tolerance, Use, Lirni_z_at ions
*-ormu 1 at i on (s)
/£ti053BR
Cruci *ers (grown for seed)
No tolerance estaoiisnec.
SLN: 7 day prehsrvest interval
through £. 0 pouncs per acre tor
foliar application. Do not make
more than £ applications.
Do not use foliage as fee:! for
11 vestock.
Seeds from treated plants must
not be consumed by nurnans or ani-
mals.
Birds
CSL.N3
£. O Ib/H
WP)
/£601300
Ginseng
IGDRftCR
Sluas
CSLND
O.3£ os/l,OOO
sq. ft
(£% P/T)
NC86OO03
UI86OOO£:
SLN - Use limited to CM.
Follar application. Heoellent.
ftpply a maximum of £ post bloom
sprays in 35 to 5O gallons by
ground equipment or in 1O gallons
by aircraft.
N. F.
l£ month prenarvest interval
througn 0.3£ ounce per 1,OOO
square feet.
BLN - Use limited to NIC and WI.
Broadcast soil application. Hp-
piy by hand held eouiprnent or
powered ground equipment. Begin
applications in the spring when
the mulch layer is moist and re-
peat in 6 week intervals as neec-
ed.
/SB017BO
Peppers (nrown for seed)
No tolerance established.
Si_N: 7 day preharvest interval
through 4.0 pounds per acre for
foliar application.
Do not apply more than £ sprays
per year.
Do not use oeopers as feed for
humans or livestock.
Vlttftftftrt
Birds
CSLND
£.0-4.0 lb/0
(75* WP)
SLN - Use limited to Ventura
County, CO.
Foliar application. Repellent.
Make £ applications by aircraft
in a minimum of 1O gallons per
acre.
104
Issued: S-0£-66
III-100b01-7
-------
Index to Pesticide Chemicals
4-
-------
£PA Incfcx to Pesticice Cnernieals
4- (*it i nY'_Tr«lu-) -j. t..-XYi_Yi_ Mt'l HYL-CPRBnVift" E
bite ana
L>os_a_aes_.ano 'i ol erance. _yset t-.^.Il!1 JL5_a.t i oy:s
F o r fii u i a T; i o n (s ;•
/330O9AA
UC^ttftA
IGDflftCft
IGDPftBP
IIFflfiEP
i ants
Ornament a A »»OQGV bnrubs and
V i nes
Do not use on or around 3lan~s
crown for fooc.
Wpoiy in f)ower oeas, csroeris,
Diantec oorcers, preenr.ouses,
under qreennouse benches, ana
around buiicing founcations.
For ornarnentai lawns ana tar-*
(coif courses ana sod farms).
refer to aoDrooriate laoeiinc
tor
*
-------
c^r) Index to Pesticide Cnermcals
•H- IKETH/LTHIQ) -3, b-XYi_Yl_ ttETHYLCP-RBflMPTE
and •Pest
P.£5 3J3es_an.a' Tolerance^ Use, Li m1tat ior-s
Formui at.ion (s)
Ornamental Plants
/ Sc'OOOCH
Slugs
Snai li
L"Si_N3
U.y?5 ib/100
gal
(75* WP) •'••
CSLND
l.S lb/100
gal
(75% WP)
£L.\ - Lise limited to Dr<.
use iimitec to commercial prowers
or orofessional aoolicators only.
Fonsr application. Ppsiy as a
full coverage spray. Repeat as
neeciec. Unoer oreennouse corci-
tions treat only a few olants ana
ODserve for varietal sensitivity
Defore treating the entire
ino.
/32000DR
Ornamental Plants
-------
i£PA Inaex -to Pesticide C.-ienucals
4- (!*£.'! i-iYi_ThilQ) -J, 5-XYLYL (*.£ TttY
bite and Pest Dosages and Tolerance, use, Limitations
F ormu 1 at i on ( = )
A.Q IH'JI f'1 RI'JceL J- _ H I art s_ar-i9 Forest ...Trees).
Ornamental Plants
Refer to T£RRc.S'l RIftL NGN^GOD CROP, (Urnarnentai
Plants and Forest Trees), Dicnoridra cluster,
Ornamental Flowering Plants cluster, and Orna-
mental Plants, for use ano limitation informa-
tion.
T^NK
900 1 5OO tter i a 1 H p p 1 1 cation
Refer to
T£R_gc£STftlQL FOOD CROP
(ftgri cultural Crops)
Pgricultural Crops CSL.NJ, Blue-
berry, Cherry, Crucifers (grown
for seed) CSLND, Peppers (grown
for seed) LSLND, Sunflower (grown
for seed) LSLN3
T£RKE_&UiIftl. NUNf-'CJDD CROP
(Ornamental Plants and Forest 'trees)
Corn (grown for decorative pur-
poses) CSi_ND
Issued: 5-02-6& 111-100501-11
108
-------
t£^rt kncex to.. l-ost iL.-i'-te f:rierniceis
4-(!*ETriYi_Ti-iHJ)-JI, 5-XYi_YI_ f»i£'l nVu.CPK
Listing of Registered Pesticide Products by Formulation
&oy-=(. OOOi 'jrj'A tecnmcal chemical
4- (rnetnyith io) -3, 5-xy iy i methyl car-hamate (10O501)
O03l£5-OUi=:5&
&075. C)UOi£' 7 b% f or rnu 1 at_i on i nt ermeo i at e
4- unethyithio) -3, 5-xylyi rnethylcarDamate (100501)
«rOib. 7503 ifa. 7S% dust
4- (rnetnylthio) -3, 5-xylyl rnethylcaroarnate (100501)
007B3£-00004*
*jacket currently unavai 1 able "for review
-------
EPP Index to Pestinoe C
4- -3, b-XY!_YL_ Mt':>VLL;nKtfW
Listing of Wen i stereo pesticide Products by Formulation (cor-t inuea
&• 0 V iii . 00 0 b /_5 V-__w E r. .£_ >.' 0' V ij 0 1 ~ O 0 '.' & o
y CT 81 0001*
IIMBlOOiiO 1NBAOO07 ME84000S
lviD84000£ KI?yOOiO*
NH840U03 NY7700O3 ^
NYB40OOS Uh8400O£ OR80O067 OR8 10036
PftBlOOl6 PW840007 UT790O01 VHa40003
VTtilOOOE1 WQ77O015 WM?y0017* WP800064
WV840OO£
*jacket currently unavailable for review
State Laoei Registrations
Cft Rec. NO.
OO5481-O38D7 OO6973-03601 O11656-OS774
Fl_ Keg. No.
OOO557 -
PR Rep. No.
0341 £0-09500
Issued: 5-0£-66 111-1O05O1-13 1 jQ
-------
EPft index to ^est icice cnerr. icals
c i x ri-
i_ i s v i ri 5 c.-f' f-icrzive Irig^ecien* (s;- .-'ounc
Report Lhemicai
Cnernicai
_ Lore _____
Common Name
_ ^ source)
EPfi ^c
.' C.TO in o r i / J -> g : v \ c B : Name
053UO1
me-caiceiyce
— use Common (\arne
Issuec: 5-O£-6fc
1 1 1-lOGbOl-1^
' ' '
-------
EPfi I no ex to Pesticiee Cnen
4-(M£TrlYi_TH10)-3, Ib-
ftux i i iary Document at ion
registration numoers OO£393-00337 (SO/. D, b/7/78 sta/via) ana
OOO004-OO£5H (bO% D, £/£/7B stamp) nave Restricted Use Pesticide on
tne label. Tne other 50% D iaoeis, 0031c:5-OO309
anc OO7501-OOO89
ao not have this
(staiv.a 7/17/Bfc),
restriction.
ana tne IB. 73*
(stamp i/liv83;
D istarno 8/30/63)
Tne fiche cooy (aatec 8/30/83) for OO783S-OOOO4 (18.75% D) was used
for the report.
Tne following Si_N registrations have been withdrawn or cancel lee oy
California:
C<47701fcl
CH790064
CM7B0120
Cft76Ol58
cancel lea
cancel led
cancel lea
cancel led
cancel lea
withdrawn
£/££/7B
8/£9/B3
fa/£9/83
Tne oosage rates from 003l£5-00£88 on blueberry and cherry have
been reduced to bring residues down to 5 pprn (from the old toler-
ance of £5 pprn;. However, the Si_N labels have not followed suit
ana still Dear the old application rate, which by Mobay's own admis-
sion, will result in residues in excess of 5 pprn.
Regarding the corn seed treatment use from O07501-OOO8B (75'/. WP) :
A letter of conditional registration (dated 7/6/86) from the Pgency
to the registrant states that the dose for pheasant and vole repel—
lancy should be 10.5 ounces a.i./cwt seed unless the aose of 3.0-
6.0 a. i. ounces given on the label can be justified.
Registration number Q074O1—0034S (£# G) gives control for all pests
including crickets and millipedes. Other labels have the use as an
"aid to control" millipedes or crickets.
Of all slug and snail bait uses, only OG31£5-QO£3t <£'/• G) gives
directions for broadcast over foliage. .Qll other labels give "Do
not apply to foliage" directions.
\\2
Issued: 5-O£-86
III-lO05Ol-a
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor,agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered/ will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger.
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases^ entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
113
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is.followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
114
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OFFICE OF.PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;*
unpublished report)
00035520 Strankowski, K.J.; Stanley, C.W. (1978) Determination of Residues
of Mesurol and Its Toxic Metabolites in Crops: Report No.
45089. (Unpublished study including report nos. 53015,
53701 and 62625, received Jun 19, 1980 under OF2362; prepared
in cooperation with International Research & Development Corp.
and others, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:099475-B)
00035522 Strankowski, K.J.; Stanley, C.W. (1977) Determination of Residues
of Mesurol and Its Toxic Metabolites: Report No. 45089.
Includes method dated Nov 21, 1975. (Unpublished study includ-
ing report nos. 53091 and 53193, received Jun 19, 1980 under
OF2362; prepared in cooperation with Morse Laboratories, Inc.
and Chemonics Industries, submitted by Mobay Chemical Corp.,
Kansas City, Mo.;CDL:099476-B)
00035523 Nichols, S.S. (1979) Addition to Synopsis of Mesurol: Residue
Chemistry on Corn. (Unpublished study received Jun 19, 1980
under OF2362; prepared in cooperation with Analytical Biochem-
istry Laboratories and others, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:099477-A)
00035524 Strankowski, K.J.; Stanley, C.W. (1978) Determination of Residues
of Mesurol and Its Toxic Metabolites: Report No. 45089.
Includes method dated Nov 21, 1975. (Unpublished study includ-
ing report nos. 52681, 54014, 65402..., received Jun 19, 1980
under OF2362; prepared in cooperation with International Re-
search and Development Corp. and others, sutmitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:099477-B)
00036477 Crawford, C.R.; Anderson, R.H. (1973) The Acute Oral Toxicity of
Mesurol Technical to Rats: Report No. 34008. Rev. (Unpub-
lished study received Mar 26, 1975 under 5F1607; sutmitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:094391-T)
00036478 Crawford, C.R.; Anderson, R.H. (1972) The Dermal Toxicity of
Mesurol Technical and Mesurol 75% Wettable Powder to Rab-
bits: Report No. 34477. (Unpublished study received Mar 26,
1975 under 5F1607; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:094391-U)
115
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY '
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00036496 Morgan, J.G.; Parton, K. (1974) Metabolism of Mesurol in Ap-
ples: Report No. 40208. (Unpublished study received Mar 26,
1975 under 5F1607; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:094391-AO)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00037132 Chemagro Corporation (1971) Synopsis of Mesurol: Analytical and
Residue Information for Seed Treatment of Corn: (Unpublished
study received Jul 2, 1975 under 6F1652; CDL:094636-A)
00046448 Mobay Chemical Corporation (1978) Recovery of Mesurol from
Blueberries and Grapes: Report No. 65401. (Unpublished study
received May 5, 1980 under 3125-288; prepared in cooperation
with International Research and Development Corp.; CDL:099423-B)
00046449 Mobay Chemical Corporation (1978) The Effect of Frozen Storage at 0
to -10F on Mesurol Residues in Various Crops: Report No.
66101. (Unpublished study received may 5, 1980 under 3125-
288; CDL:099423-C)
00046450 Stanley, C.W.; Kottman, R.F.; Bingman, K.J. (1979) Metabolism and
Excretion of Mesurol by Poultry: Report No. 66777. (Unpub-
lished study received May 5, 1980 under 3125-288; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:099423-D)
00046451 Stanley, C.W.; Kottman, R.F.; Bingman, K.J. (1979) Radioactive Res-
idues of 14C Mesurol in Poultry: Report No. 66778. Rev.
(Unpublished study received May 5, 1980 under 3125-288; submit-
ted by Mobay Chemical Corp., Kansas City, Mo.; CDL:099423-E)
00046453 Becker, B.D. (1979) Recovery of Mesurol fron Grape Must: Re-
port No. 68215. (Unpublished study received May 5, 1980 under
3125-288; prepared in cooperation with International Research &
Development Corp., submitted by Mobay Chemical Corp., Kansas
City, MO.; CDL:099423-H)
116
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00056044 Mobay Chemical Corporation (1976) Synopsis of Mesurol Residue
Chemistry on Citrus. Summary of studies 095325-B through
095325-D. (Unpublished study received Cct 15, 1976 under 3125-
234; CDL:095325-A)
00056045 Strankowski, K.J.; Stanley, C.W. (1975) Determination of Residues
of Mesurol and Its Toxic Metabolites in Crops: Report No.
45089. Method dated Npv 21, 1975. (Unpublished study re-
ceived Get 15, 1976 under 3125-234; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:095325-B)
00056047 Chemonics (1976) The Effect of Frozen Storage at 0 to -10 on
Mesurol Residues in Orange Peel and Pulp: Report No. 49580.
(Unpublished study received 3125-234; submitted by Mobay Chemi-
cal Corp., Kansas City, Mo.; CDL:095325-D)
00060625 Johansen, C.; Hutt, R. (1962) Bee Poisoning Investigations, 1962:
Report No. 10617. (Unpublished study received Mar 27, 1974 un-
der 4F1485; prepared by Washington State Univ., submitted by
Chemagro Corp., Kansas City, Mo.; CDL:092011-E)
00083437 Lamb, D.W.; Matzkanin, C.S. (1977) A Comparison of the Acute Oral
Toxicities of Mesurol Technical to Fasted and Non-fasted
Rats: 51420. (Unpublished study received Aug 30, 1979 under
3125-234; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:098990-A)
00115224 Mobay Chemical Corp. (1982) Addition No. 2 to the Brochure En-
titled: Mesurol Residue Chemistry on Grapes: Document No. AS 82-
1702. (Compilation; unpublished study received Cct 4, 1982
under 3125-288; CDL:071113-A)
00115226 Kroetlinger, F. ; Loeser, E.; Vogel, 0. (1981) H 321: (..., the Ac-
tive Ingredient of MESUROL)—Chronic Toxicity Study on Rats—
(2-year Feeding Experiment): Bayer Report No. 10039; Mobay ACD
Report No. 69844. (Unpublished study received Cct 4, 1982 under
3125-288; prepared by Bayer AG., W. Ger., submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:071114-B)
117
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OFFICE OF .PESTICIDEPROGRAMS
REGISTRATION STANDARD)?BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00116555 Mobay Chemical Corp. (1970) Mesurol (Bay 37344): Metabolic, Analyt-
ical, Residue, and Flavor Information (Apples and Pears). (Com-
pilation; unpublished study received Sep 9, 1971 under 1G1030;
CDL:091909-A; 091907)
00123980 Mobay Chemical Corp. (1974) Mesurol: Metabolic, Analytical, Resi-
due and Flavor Information for Foliar Spray Applications on
Apples, Cherries, Peaches and Pears. (Compilation; unpublished
study received Mar 26, 1975 under 5F1607; CDL:094388-A; 094387;
094386)
00124617 Lorke, D. (1971) Mesurol Active Ingredient (Bay 37 344): Studies
on Rats for Embryotoxic and Teratogenic Effects: Report
No. 3133; 32142. (Unpublished study received Mar 26, 1975
under 5F1607; prepared by Farbenfabriken Bayer, AG, W. Ger.,
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:
094389-L)
00124968 Abdel-Wahab, A.; Ruhr, R.; Casida, J. (1966) Fate of C14-carbonyl-
labeled aryl methylcarbamate insecticide chemicals in and on
bean plants. J. Agr. Food Chem. 14(3):290-297. (Submitter
18274; also In unpublished submission received Jul 15, 1976
under 3125-EX-135; submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:227756-E)
00125528 Mobay Chemical Corp. (1977) Addition No. 1, Mesurol Residue Chem-
istry on Apples, Cherries, Peaches and Pears, to Brochure En-
titled: Mesurol—Metabolic, Analytical, Residue and Flavor In-
formation for Foliar Spray Applications on Apples, Cherries,
Peaches and Pears: Document No. AS77-1086. (Compilation; un-
published study received Jul 20, 1977 under 3125-288; CDL:
096264-A)
00125530 Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Cole
Crops: Document No. AS77-559. (Compilation; unpublished study
received May 5, 1977 under 3125-234; CDL:096118-A)
00125532 Mobay Chemical Corp. (1971) Mesurol: Analytical and Residue In-
formation for Seed Treatment of Corn. (Compilation; unpub-
lished study received Feb 14, 1973 under unknown admin, no.;
CDL: 126889^)
118
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00125537 Pfipharmecs (1957) Study of the Efficacy of Tetracycline and Terr-
amycin on Fish. (Compilation; unpublished study received
Dec 5, 1956 under PP0111; CDL:092391-B)
00127628 Mobay Chemical Corp. (1977) Addition No. 1 to Brochure Entitled:
Mesurol—Residue Chemistry on Berries: Document No. AS77-259.
(Compilation; unpublished study received Feb 25, 1977 under
3125-EX-139; CDL:096002-A)
00127630 Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Grapes:
Document NO. AS77-337. (Compilation; unpublished study re-
ceived Mar 4, 1977 under 3125-EX-140; CDL:096017nA)
00127632 Mobay Chemical Corp. (1976) Mesurol: Residue Chemistry on Arti-
chokes and Tomatoes: Document No. AS77-561. (Compilation; un-
published study received May 5, 1977 under 3125-234; CDL:
096115-A)
00127634 Mobay Chemical Corp. (1976) Mesurol: Residue Chemistry on Beans:
Document No. AS77-565. (Compilation; unpublished study received
May 5, 1977 under 3125-234; CDL:096117-A)
00127635 Mobay Chemical Corp. (1978) Addition No. 2 to Brochure Entitled:
Mesurol: Residue Chemistry on Berries (Dated Dec 1, 1976):
AS19-1643. (Compilation; unpublished study received Sep 14,
1979 under 3125-288; CDL:098964-A)
00127638 Nelson, D.; Roney, D. (1979) Acute Toxicity of Mesurol Technical
to Daphnia magna: Report No. 67264. (Unpublished study re-
ceived Sep 14, 1979 under 3125-288; submitted by Mobay Chemical
Corp., Kansas City, MO; CDL:098965-D)
00128119 Lamb, D.; Carsel, M.; Mallicoat, D.; et al. (1982) Methiocarb Re-
production Study with Bobwhite Quail: 82400. (Unpublished study
received Feb 10, 1983 under 3125-234; submitted by Mobay Chemi-
cal Corp., Kansas City, MO; CDL:071396-A)
00128939 Hoffman, K.; Schilde, B. (1980) H 321 (Mesurol Active Ingredient—
Mercaptodimethur): Chronic Toxicity Study on Dogs (Two-year
Feeding Experiment): Report No. 9626; 69364. (Unpublished study
received Jun 15, 1983 under unknown admin, no.; prepared by
Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:250497-A)
119
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00143213 Tesh, J.; Ross, F.; Seeker, R. et al. (1981) H 321 : Effects of O-
ral Administration upon Pregnancy in the Rabbit: 2. Main Study:
81/BAG013/598. Unpublished study prepared by Life Science Re-
search. 60 p.
00145802 Atwell, S.; Murphy, J. (1978) Soil Absorption and Desorption of
[Carbon 14] Mesurol: Mobay report No. 66145. Unpublished study
prepared by Mobay Chemical Corp. 14 p.
00149362 Mobay Chemical Corporation (1985) [Chronic Toxicity Study on Dogs]:
Report No. 69364: Addendum. Unpublished study. 42 p.
00150628 Lamb, D. (1981) Acute Toxicity of Technical Methiocarb (Mesurol) to
Bluegill and Rainbow Trout: Study Nos. 81-066-03 and 80-066-12:
Mobay Report No. 69407. Unpublished study prepared by Mobay
Chemical Co. 9 p.
00154537 Mobay Chemical Corp. (1982) Mesurol: Residue Chemistry on Pecans.
Unpublished compilation. 92 p.
00155042 Mobay Chemical Corporation (1981) [Residue Data for Mesurol.] Un-
published compilation. 1059 p.
00155046 Strankowski, K.; Parker, G. (1981) [Carbon-14] MESUROL Rotational
Crop Study. Unpublished Mobay report 69270. 15 p.
00155055 Strankowski, K. (1979) Metabolism of MESUROL in Rice: Report No.
66776. Unpublished study prepared by Mobay Chemical Corpora-
tion. 46 p.
00155057 Mobay Chemical Corporation (1981) [Residue Data for MESUROL]. Un-
published compilation. 793 p.
00155967 Carlisle, J. (1985) Toxicity of Methiocarb (Mesurol) Technical to
Early Life Stages of Rainbow Trout: Study No. 85-666-02: 90579.
Unpublished study prepared by Mobay Chemical Corp. 19 p.
120
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
MRID CITATION
00158770 Mobay Chemical Corp. (1986) Mesurol: Residue Chemistry on Blue-
berries and Cherries; March 13, 1986: Brochure No. 1444. Unpub-
lished compilation. 280 p.
121
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methiocarb Standard
GS0577001
Watts, R.R. 1975 Method Trial For'
Mesarol On Corn Grain. Located in
Section D of PP# 6F1652.
GS0577002
GS0577003
GS0577004
GS0577005
GS0577006
Mahijani, G.P. 1977. Results of
Method Tryout For Mesurol and its
sulfoxide metabolite in milk and
Beef Liver. Submitted under
PP# 7F1988. (EPA accession number
072301).
Mobay Chemical Corp. 1978. Chemagro
Agricultural Division Experiment:
661-1609-77D. Report No. 66573.
Located in Section D of PP# OF2362.
Mobay Chemical Corp. 1981. Addition
No. 2 to "Mesurol, the Effects on
the Environment - Environmental
Chemistry"; Vol. I. Received May 29,
1981 under PP# OF2362. (EPA Accession
Number 070111).
Mobay Chemical Corp. 1981. Addition
No. 2 to "Mesurol, the Effects on the
Environment - Environmental Chemistry";
Vol II. Received May 29, 1981 under PP#
OF2362. (EPA Accession Number 070112).
Hudson, R.H.; Tucker, R.K. Haegele, M.A.
(1984) Handbook of Toxicity of Pesticides
to Wildlife. USDI Publication 153,
Washington, D.C.
U.S. GOVERNMENT PRINTING OFIMCE: 1987-716-002/60600
122
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OMB Approval No. 2000-0468 (Expires 12-31-83)
lAppri
I
PA REGISTRATION NO.
FIFKA SECTION 3(C)(2)(6) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" datz imposed by the FIFRA section 3(C)(2)(B) notice comii.nsil in the
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or
-------
OMB Approval No. 2000-0468 (Expires: 12-31-83)
[ifTo qualify, rcrtify &LL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. ! 3fii duly autfiorizcd to represent the following firm(s) who are subject to the require-
ments- o* * Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
tc sut?TV' natfl concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT OATE
ACTrVG INGBEOIEr.'T
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm hat offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following dste(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 tc submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
rjie whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA form BS80-6 (1042)
124
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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
125
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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
Oxidiz ing/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
126
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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:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice .from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
127
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