Environ
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540/RS-89-dl2_
Guidance for the
ncieyib trillion OT
Pesticide Products
Containing RESMETHRIN
as the Active Ingredient
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OMB Control No.2070-0057
GUIDANCE FOR THE REREGISTRATION OF PESTICIDE
PRODUCTS CONTAINING RESMETHRIN
AS THE ACTIVE INGREDIENT
OPP Chemical No. 097801
GS 0421
CAS (DOCKET) NUMBER: 10453-86-8
December 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chemical (s) Covered by this Standard ......... 4
A. Description of Chemical ............. 4
B. Use Profile ................... 4
III. Agency Assessment ................... 6
A. Summary ..................... 6
B. Health Effects Assessment ............ 9
C. Environmental Characteristics and Effects. ... 12
D. Tolerance Reassessment ............. 15
IV. Regulatory Position and Rationale ........... 17
A. Regulatory Positions .............. 17
B. Criteria for Registration ............ 20
C. Acceptable Ranges and Limits .......... 20
D. Required Labeling ................ 22
V. Products Subject to this Standard ........... 24
VI. Requirement for Submittal of Generic Data ....... 27
A. What are generic data? ............. 27
B. Who must submit generic data? .......... 27
C. What generic data must be submitted? ...... 28
D. How to comply with DCI requirements ....... 29
E. Registrant requests regarding data
requirements and Agency responses ........ 31
F. Test protocols and standards .......... 32
G. Procedures for requesting a change in protocol.. 32
H. Procedures for requesting extensions of time . . 33
I. Data Format and Reporting Requirements ..... 33
J. Existing stocks provisions upon suspension or
cancellation .................. 34
VII. Requirement for Submittal of Product-Specific Data . . 35
VIII. Requirement for Submittal of Revised Labeling ..... 36
IX. Instructions for Submittal .............. 37
A. Manufacturing use products (sole active) .... 37
B. Manufacturing use products (multiple active) . . 38
C. End use products (sole active) ......... 39
D. End use products (multiple active) ....... 39
E. Intrastate Products ............... 40
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APPENDICES
I. DATA APPENDICES
Guide to Tables 41
Table A 44
Table B 65
II. LABELING APPENDICES 70
Summary of label requirements and table 71
40 CFR 156.10 Labeling Requirements 72
Physical/Chemical Hazards Labeling Statements 81
Storage Instructions 82
Pesticide Disposal Instructions 83
Container Disposal Instructions 84
III. BIBLIOGRAPHY APPENDICES 85
Guide to Bibliography 86
Bibliography 88
IV. FORMS APPENDICES 92
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data
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ADI
a.i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
LC50
LD50
LOT
LEL
MPI
GLOSSARY OF TERMS AND ABBREVIATIONS
An acceptable daily intake of pesticide residue based
cm -f -' :'..•••'..'.'
Active ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial or aquatic ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest dose tested in a toxicity study.
Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/l or ppm.
Median lethal dose - a statistically derived single
dose than can be expected to cause death in 50% of the
test animals, when administered by the route indicated
(oral : dermal). It is expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
Lowest dose tested in a toxicity study.
Lowest Effect Level from a toxicity test in animals.
Maximum Permissible Intake of residues.
iii
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MRID
MP
NPDES
NOEL
OPP
PADI
ppm
RfD
TMRC
Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
Manufacturing Use Product
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake is an acceptable
daily intake of pesticide residue that is based on a
limited data base.
Parts per million
Reference Dose is an estimate of a daily exposure to
the human population (including sensitive subgroups)
that is likely to be without an appreciable risk of
deleterious effects during a lifetime. The reference
dose is a replacement term for the term acceptable
daily intake (ADI).
Theoretical Maximum Residue Contribution is an
estimate of dietary exposure obtained by multiplying
residue tolerance levels for a given pesticide by the
average daily per capita food consumption figure, then
adding the exposure figure for each crop. The TMRC is
usually expressed in terms of mg/kg of food.
iv
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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.
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The detailed scientific review, which is not contained in
this document, but is available upon request,1 focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient. However, during the review of these data the Agency
is also looking for potential hazards that may be associated
with the end use products that contain the active ingredient.
The Agency will apply the provisions of this Registration
Standard to end use products if necessary to protect man and the
environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. See Section 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. Submittal of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent
to Suspend (in the case of failure to submit data).
The scientific reviews and Compendium of Acceptable ,
Uses may be obtained from the OPP Public Docket. Write to
OPP Public Docket, Field Operations Division (^7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the pesticide.
If the Agency determines that the risks of the pesticide's use
outweigh the benefits of use, the Agency may propose additional
regulatory actions, such as cancellation of uses of the pesticide
which have been determined to cause unreasonable adverse effects
on the environment.
EPA has authority under the Data Call-in (DCI) provisions of
FIFRA 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
unreasonable adverse effects of a pesticide at any time that
they become aware of such information. Registrants must notify
the Agency of any information, including interim or preliminary
results of studies, if that information suggests possible
adverse effects on man or the environment. This requirement is
independent of the specific time requirements imposed by EPA for
submittal of completed studies called in by the Agency and
continues as long as the products are registered under FIFRA. '
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II. CHEMICALS COVERED BY THIS STANDARD
A. Description of Chemicals
Resmethrin is the American National Standards Institute
(ANSI) common name for [5-(phenylmethyl)-3-furanyl] methyl
2 ,2-dimethyl-3- (2-methyl-l-propenyl) eyelopropanecarboxylate.
Resmethrin is composed of 30% cis and 70% trans isomers. The d-
trans isomer is also known as bioresmethrin (ISO). Resmethrin
is a second generation pyrethroid insecticide that is effective
on a broad spectrum of insects. Resmethrin is approximately 20
times more effective than natural pyrethrum in housefly control
and may be formulated with a synergist like most pyrethrum
products. Resmethrin is more stable than pyrethrum, but
decomposes fairly rapidly in sunlight or exposure to air.
Other identifying characteristics and codes are:
Empirical formula: C22H26°3
Molecular weight: 338.4
CAS Registry No.: 10453-86-8
OPP (Shaughnessy) No.: 097801
General Description of Chemical
Resmethrin is a waxy off-white to tan solid synthetic
pyrethroid with a chrysanthemate odor. It is insoluble in water,
10% in kerosene, and very soluble in xylene, methylene chloride,
isopropyl alcohol and aromatic hydrocarbons.
B. Use Profile
The bulk of resmethrin use is in and around households
(indoor and outdoor) and in food handling establishments. Other
uses of resmethrin include treatment of ornamentals (outdoor and
greenhouse use), commercial/industrial uses, mosquito control,
use on pets and horses (non-food use) and insect control in
uncultivated nonagricultural areas (i.e. fly control on beaches
and at recreational sites).
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Resmethrin is primarily formulated into pressurized liquids
and ready to use solutions. Refer to Table I. It is also
formulated as an emulsifiable concentrate, soluble concentrate,
and on impregnated materials. Resmethrin is most frequently
formulated with the following pesticides:
D-trans allethrin 155 products
Piperonyl butoxide 79 products
Chlorpyrifos 76 products
Tetramethrin 64 products
Pyrethrins 29 products
Allethrin 19 products
There are about 1200 products which contain resmethrin. Of
these 1200 products, only 25 products account for over 70% of the
total use of resmethrin.
Table I. Summary Listing of Registered Resmethrin Products
Registration Status
Federal SLN
Technical 7
Formulation intermediate 65
Impregnated materials 2
Emulsifiable concentrate 114 45
Soluble concentrate 50 44
Ready-to-use solution 392 3
Pressurized liquid 507 4
Totals 1137 57
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III. AGENCY ASSESSMENT
The Agency has reviewed all data in the Agency files as of
June 13, 1988 supporting the registration of resmethrin. Data
received by the Agency after this date have not been reviewed
for the purposes of this standard. This section discusses the
Agency's scientific findings and conclusions based on these
data.
A. Summary
The Agency has reviewed all available data for resmethrin
and determined that there are data gaps in the areas of
toxicology, residue chemistry, environmental fate, and ecological
effects.
A summary of these gaps appears in Table II. Note that this
list contains only summary information on the data gaps. More
detailed information relating to the issues can be found in the
Data Tables in Appendix I.
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Table II. SUMMARY OF DATA GAPS FOR RESMETHRIN
Toxicology
Acute Oral
Acute Dermal
Subchronic dermal (21-Day and 90-Day)
Mutagenicity and Genetic Toxicity (full battery of
studies including gene mutation, chromosome aberration,
and other mechanisms of mutagenicity).
General metabolism and pharmacokinetics
Residue Chemistry
Nature of the residue (metabolism)
- Plants
- Livestock
Residue analytical methods
Storage stability
Magnitude of residue — Meat/milk/poultry/eggs
Food handling establishments
Environmental Fate
Hydrolysis
Photodegradation
- water
Metabolism studies (Lab)
- aerobic soil
- anaerobic aquatic
- aerobic aquatic
Mobility
- Leaching and adsorption/desorption
- Volatility (Lab)
Dissipation (Field)
- soil
- aquatic (sediment)
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Table- II. SUMMARY OF DATA GAPS FOR RESMETHRIN - Continued)
Ecological Effects
Avian and Mammalian Testing
- Avian Dietary
- Avian Reproduction
Aquatic Testing
- Fish early life stage
- Freshwater fish LC$Q
- Acute LCso freshwater invertebrates
- Acute LCcQ estuarine and marine organisms
- Aquatic invertebrate life cycle
Nontarget Area Phytotoxicity
Tier I
- Seedling germination/seedling emergence
- Vegetation vigor
- Aquatic plant growth
Nontarget Insects
- Honeybee: toxicity of residues on foliage
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B. Health Effects Assessment
1. Acute Toxicity
Resmethrin (technical) is moderately or slightly toxic via
oral (LD50 - 750 to 4500 mg/kg), dermal (LD50 - 2500 mg/kg) and
inhalation (LC50 of > 9.49 mg/1 (4 hr. exposure)). It is not
considered to be an eye irritant (Toxicity Category IV), a
dermal irritant (Toxicity Category IV) or a skin sensitizer in
guinea pigs. No neurotoxicity testing is being required since
resmethrin is not an organophosphate.
The acute oral toxicity studies and the acute dermal
toxicity study have been classified as supplemental or invalid.
New studies are required.
2. Sut?c,h,rQnic Toxicitv
A 90-Day subchronic inhalation study in rats did not
demonstrate a definite NOEL. At the lowest dose level tested
(0.1 mg/l), there was evidence of behavioral reactions to
treatment, decreased blood levels of glucose (in males),
decreased body weights and increased serum urea levels (in
females). The atmospheric dose levels tested were 0, 0.1, 0.3,
and 1.0 mg/1 of resmethrin. Subchronic oral toxicity studies are
not being required because acceptable chronic studies satisfy
this requirement.
Resmethrin was evaluated for its potential to cause
neuropathy in rats (axonal swelling and splitting) that is
sometimes associated with pyrethroid insecticides. Resmethrin
did not induce neuropathy after dietary dose levels that are
near fatal (12,640 ppm for seven days) or subchronic dosing
(1250 ppm for 32 weeks).
No subchronic dermal (21-Day) data were available for
review. A study is required. No 90-Day subchronic dermal data
were available for review. A study is required because one of the
currently registered uses (Cat and Dog, Animal Treatment -
Veterinary Use Only) may result in prolonged and/or repeated
exposure to humans.
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3. Chronic Toxicity
The Agency has adequate data to characterize the chronic
effects of resmethrin.
A rodent (rat) chronic toxicity study did not establish a
definite NOEL since there was some evidence of dose related
hepatocellular hypertrophy at the lowest dosage level tested
(500 ppm or 25 mg/kg/day). This type of response in the liver is
regarded as a manifestation of the well recognized phenomenon of
hepatic microsomal enzyme system induction which is not regarded
as a serious toxicological concern. It is the Agency's opinion
that this study does not need to be repeated at a lower dosage.
The NOEL in the rat is 500 ppm. At the LEL of 2500 ppm increased
liver weight and severe pathological lesions in this organ were
observed. Further dose related increases in liver weight, liver
pathology, and also increases in thyroid weight and incidence of
thyroid cysts were observed at the 5000 ppm (HDT) level.
A dog chronic study demonstrated a NOEL of 10 mg/kg/day and
a LEL of 30 mg/kg/day. At the 30, 100 and 300 mg/kg/day levels
there were dose related increases in liver weight.
4. Oncodenicity
Resmethrin was determined not to be oncogenic for rats at
dosage levels up to and including 5000 ppm (HDT). The dose
levels tested on rats were 0 ppm, 500 ppm (25mg/kg/day) , 2500
ppm (125 mg/kg/day) and 5000 ppm (250 mg/kg/day). Additional
historical control information has been requested with respect to
the thyroid gland. Resmethrin does not produce oncogenic effects
in mice at dosage levels up to and including 1000 ppm (HDT) when
administered in the diet for 18 months. The dose levels tested on
mice were 0 ppm, 250 ppm (37.5 mg/kg/day), 500 ppm (75
mg/kg/day), and 1000 ppm (150 mg/kg/day).
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5. Developmental Toxicity and Teratoqenicity
Two acceptable teratogenicity studies for resmethrin are
available. Doses tested were: 0, 20, 40, and 80 mg/kg/day. The
teratogenic NOEL for rats was 40 mg/kg/day based on slight
increase in aberrations in skeletal findings. There was an
indefinite maternal NOEL with some decrease in food consumptions
at all dose levels tested and a body weight decrease at the 80
mg/kg/day level.
The doses tested in rabbits were 0, 10, 30, and 100
mg/kg/day. The teratogenic, maternal and fetotoxic NOELs in the
rabbit were greater than 100 mg/kg/day (HDT).
6. Reproduction*
The Agency has an acceptable multigeneration reproduction
study in the rat. A definite NOEL was not established in this
study since there were marginally statistically significant
increases in the number of pups born dead and decreases in pup
weight at weaning at the lowest dosage level tested (500 ppm or
25 mg/kg/day). The observed effects were judged to be minimal
when the low dose groups were compared with the controls. An
additional multigeneration reproduction study is not required.
7. Mutagenicity
No acceptable mutagenicity and genetic toxicity data are
available. A gene mutation study was determined to be
unacceptable in satisfying the data requirements. A full battery
of studies including a new gene mutation study, chromosomal
aberration and other mechanisms of mutagenicity are required.
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8. General Metabolism
There are no general metabolism studies available to the
Agency. A study in the rat is required.
9. Human Exposure (or Reentry)
Based on the toxicological profile of resmethrin ( low
acute toxicity, non-oncogenic, minimal reproductive and
fetotoxic effects), data on human exposure and reentry are not
required.
C. Environmental Characteristics and Effects
1. Environmental Fate
No acceptable or supplemental data on resmethrin are
available to assess the environmental fate and transport, and
potential exposure of humans and nontarget organisms. The
potential for resmethrin to contaminate groundwater is unknown.
However, based on the non-leaching characteristics of related
pyrethroid compounds and the fact that more than half of the
130,000 Ibs. of resmethrin used annually is used indoors, it is
not likely' that use of this chemical will pose appreciable risks
to groundwater. Also, in a Mobility - Column Leaching Study,
while unacceptable in meeting current EPA Guidelines,
[14C]resmethrin exhibited virtually no leaching.
The following data are needed to fully assess the
environmental fate and transport of resmethrin for its current
uses: hydrolysis, photodegradation in water, aerobic and
anaerobic aquatic and soil metabolism, leaching/adsorption-
desorption, terrestrial and aquatic field dissipation, and fish
accumulation studies.
2. Ecological Effects
There is sufficient data to assess the acute oral toxicity
of resmethrin in birds (LDso >2000 mg/kg - California quail) as
slightly toxic.
12.
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Resmethrin is very highly toxic to bluegill sunfish, LC5Q
values range from 0.75 to 2.6 ug/L, and rainbow trout with LCjy
values ranging from 0.28 to 2.4 ug/L. The most sensitive aquatic
organism is the rainbow trout, with an LC50 of 0.28 ppb. The
bluegill LC50 is 0.75 ppb.
Direct application to water is the worst case scenario for
the exposure of aquatic species. This case is likely to occur
with the labeled use of Resmethrin in mosquito control, because
listed sites include: shorelines, beaches, tidal marshes, marsh
lands, marshy areas, stagnant pools, and swamps which consist of
shallow water habitats. As indicated below, direct application
to water can be expected to have an adverse impact on aquatic
organisms.
Resmethrin Impact on Aquatic Organisms
EEC Exceedance of
Label the LC50 for Trout
Application Rate EEC^^- and
Mosquito 0.007 Ib/Acre 5.1 ppb 18x and 7x
Mosquito 0.001 Ib/Acre 0.73 ppb 2.6x and Ix
Stable flies
(at beaches 0.017 Ib/Acre 14 ppb 50x and 19x
in FL)
Chrysops
deer flies 0.05 Ib/Acre 36.7 ppb 131x and 49X
l. Expected environmental concentration for a one acre pond 6
inches deep.
2. LCso for Rainbow trout = .28 ppb and LC5Q for bluegill = .75
ppb.
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The following data were not available to assess the ecological
effects of resmethrin. These studies are required:
Avian dietary toxicity
Avian reproduction
Effects on freshwater invertebrates
Effects on estuarine and marine organisms
Fish early life stage
Aquatic plant testing
Degradate toxicity
Persistence testing
A complete hazard assessment for aquatic invertebrates,
marine/estuarine species or nontarget plants cannot be completed
until the outstanding data requirements are satisfied.
Beneficial Insects
Resmethrin is highly toxic to honey bees in a laboratory
acute contact study (LD50 - 0.063 ug/bee). No data were
available on the toxicity of foliar residues. These studies are
required.
Endangered Species
The uses of resmethrin do not present a potential hazard to
endangered birds or mammals on an acute basis. However,
resmethrin does present a potential hazard to endangered fish on
an acute basis.
Because of the toxicity of resmethrin, and the potential for
exposure, resmethrin has the potential to adversely effect
endangered species. Resmethrin was included in a previous
Consultation submitted to the U.S. Fish and Wildlife Service for
endangered species hazard assessment. However, the endangered
species hazard assessment cannot be completed without additional
information concerning the effects of resmethrin on bird
reproduction, fish early life stage, aquatic invertebrate,
marine/estuarine species, and phytotoxicity. When available, EPA
will submit any additional data concerning levels of resmethrin
that may affect these species to the U.S Fish and Wildlife
Service. If a jeopardy opinion is returned by FWS, appropriate
action will be taken by EPA to limit the use of resmethrin to
protect jeopardized species.
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d. Tolerance Reassessment
Residue Chemistry
No tolerances have been established for residues of
resmethrin in or on any plant or animal commodities. A food
additive tolerance of 3ppm (40 CFR 185.5300) has been
established for residues of resmethrin in food items resulting
from treatment of food handling establishments and storage
areas.
No Codex MRLs have been established for residues of
resmethrin in or on food or feed.
Nature of the Residue in Plants
Presently no tolerances or exemptions from the requirement
of tolerances exist for residues of resmethrin in or on plant
commodities. Data on the metabolism of resmethrin in tomatoes,
lettuce, and wheat were submitted in support of proposed uses on
cucumbers and tomatoes. These data were determined to be
inadequate. These studies will be required if products are
intended for use on agricultural food or feed crops.
Nature of the Residue in Animals
No tolerances or exemptions from the requirement of
tolerances for resmethrin residues in animal commodities have
been established. The metabolism of resmethrin in milk has been
adequately described; virtually all of the 14C-labeled
resmethrin present in milk was identified as unchanged parent
material.
However the metabolism of resmethrin in animal tissues was
not adequately understood because the studies reviewed did not
identify the total terminal residues in meat, fat, liver and
kidney. No poultry metabolism data were available for review.
Data depicting the nature of residue in ruminants and poultry
must be submitted to support the use of resmethrin in food
handling establishments.
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Residue analytical Methods
Adequate gas-liquid chromatographic/flame ionization
detection (GLC/FID) methods are available for collection of data
pertaining to residues of resmethrin per s_e_ in or on food
products and inanimate surfaces. Data for PAM I Multiresidue
Protocols I, II and III are required for resmethrin and any
metabolites of concern.
Tolerance Assessment - ADI Assessment
The RfD is 0.03 ma/ka/dav. This RfD determination is based
on the rat multi-generation reproduction study which
demonstrated minimal effects at the lowest dosage level tested
(500 ppm, 25 mg/kg/day). The LEL dosage level used for this study
was used together with uncertainty factors of 100 to account for
the inter- and intra- species differences in toxicity and an
additional 10 to account for the lack of a definite NOEL for the
study.
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationale
Based on the review and evaluation of all available data on
resmethrin, the Agency has made the following determinations.
Where label revisions are specified, language is set forth in
Section B of this Chapter.
1. The Agency is not placing resmethrin into Special Review
at this time. EPA has insufficient information to determine that
the criteria of 40 CFR 154.7 for special review are met. The
Agency will further evaluate the potential risk to aquatic
species when data required under the Standard are submitted.
Rationale; The Agency has significant concerns about the
toxicity of resmethrin to aquatic species. Resmethrin is highly
toxic to fish, and, based on its structural similarity to other
pyrethroid compounds, may also be highly toxic to aquatic
invertebrate species. The Agency is requiring additional data on
aquatic invertebrate toxicity and the fate of resmethrin in the
environment.
Theoretical calculations of exposure to aquatic species
based upon maximum application rates suggest that resmethrin may
pose a hazard to aquatic species from its agricultural and
mosquito uses. All calculated EECs for runoff from agricultural
use and direct application to aquatic sites for mosquito control
were above the LC5Q for both bluegill sunfish and rainbow trout.
Even the lowest application rate for mosquito application
theoretically equals or exceeds the LC5Q for fish.
2. The Agency is imposing restricted use classification for
certain outdoor uses of resmethrin, based upon its toxicity to
fish.
Rationale; Resmethrin meets the criteria for restricted use
based on acute fish toxicity. All products with outdoor use
patterns for mosquito abatement and insect control at
uncultivated nonagricultural sites ( i.e. beaches, parks,
campsites woodlands, atheletic fields, golf courses, swamps,
tidal marshes, refuse and waste sites, residential areas and
municipalities) are classified as Restricted Use because of
their high toxicity to fish. These products will be required to
bear appropriate labeling.
3. The Agency is not requiring the use of protective
clothing or establishment of reentry intervals for resmethrin.
Rationale; Based on available toxicological information,
there are no concerns with human exposure which will require
personal protective clothing and specific field reentry
intervals.
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4. The Agency is not requiring the addition of a
groundwater advisory statement to resmethrin labels.
Rationale; Although the potential for resmethrin to
contaminate groundwater is unknown, it is not likely that the
use of this chemical will pose an appreciable risk to
groundwater because:
A. Almost half of the 130,000 Ibs. of resmethrin produced
annually is used indoors.
B. Other structurally similar pyrethroid compounds do not
leach.
Also, the mobility data reviewed, while unacceptable in meeting
current EPA Guidelines, indicated that that resmethrin does not
leach and remains near the soil surface.
5. The available residue chemistry data are insufficient to
permit the Agency to conduct a full tolerance reassessment.
However, the toxicology data base is relatively complete.
The Agency will grant tolerances for food uses if adequate
residue data are submitted to support the tolerance request.
Rationale; Data gaps exist depicting the nature of residue
in representative food products resulting from the contamination
of resmethrin treatments in food handling and storage areas; the
nature of residue (metabolism) in plants and livestock;
analytical residue methods; and storage stability.
6. The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain of the data being required by the
Agency are essential to resolve risk concerns, or may generate
the need for further studies which should be initiated as soon as
possible. The following studies have been identified to receive
priority review as soon as they are received by the Agency:
158.150 Wildlife and Aquatic Organisms
0 These studies will permit the Agency to determine
whether resmethrin exceeds the risk criterion for
special review.
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158.290 Environmental Fate
0 These studies are tiered studies that may require
the generation of additional studies and will be
used to determine whether resmethrin exceeds the
risk criteria for special review.
8. Continuation of registration. While data gaps are being
filled, currently registered manufacturing use products (MPs) and
end use products (EPs) containing resmethrin may be sold,
distributed, formulated and used, subject to the terms and
conditions specified in this Standard. Registrants must provide
or agree to develop additional data, as specified in the Data
Appendices, in order to maintain existing registrations.
Rationale: Under FIFRA, the Agency 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 and labeling changes arising from available data.
Required data will be reviewed and evaluated, after which the
Agency will determine if additional regulatory actions are
necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain resmethrin, bear required labeling, and
conform to the product composition, acute toxicity limits, and
use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this pesticide.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as impurities
found at greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing this pesticide provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each product
is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the use patterns listed below. The EPA compendium of
Acceptable Uses (for availability, see page 1) lists all
registered uses, as well as approved maximum application rates
and frequencies.
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Domestic! Indoor Household
This use pattern includes applications to control insects in
indoor areas of single family homes,mobile homes, townhouses,
condominiums and apartments.
Domestic:Outdoor Household
This use pattern includes applications to all exterior
portions of the house including foundations, door and window
frames, screens, eaves, porches, patios, garage areas, outdoor
sheds, etc. This use pattern also includes treatment of the
yards surrounding the dwelling for household pests. This use
pattern specifically excludes all treatments to structures
against standard pest such as termites and to yards for pests
whose only damage is to the vegetation (e.g. sod webworms, gypsy
moths).
Indoor Food Handling Establishments (Edible product areas)
This use pattern includes food processing plants, eating
establishments (e.g. restaurants), supermarkets, and food
warehouses. An edible product area of food handling
establishments include areas for receiving, serving, storage,
preparing and processing.
Greenhouse ornamental
This use pattern includes application to ornamental plants
in commercial and retail greenhouses. It does not include use on
food crops grown in greenhouses.
Mosquito Control
This use pattern includes application to specific sites for
the control of mosquitos, flies, and midges. Resmethrin may be
applied under this use pattern to the following sites: parks,
campsites, woodlands, athletic fields, golf courses, swamps,
tidal marshes, refuse and waste sites, residential areas and
municipalities. It may not be applied to agricultural sites.
Animal Treatment
This use pattern includes applications to animal premises
(i.e., barns, stables, kennels) and direct applications to
livestok (non-food) and pets for control of fleas, flies and
ticks.
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D. LABELING
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after December 31, 1989,
unless the product bears an amended label which complies with the
requirements of this standard.
No pesticide product containing this pesticide may be
distributed or sold after December 31, 1990 unless the product
bears an amended label which complies with the requirements of
this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the active
ingredient as:
ACTIVE INGREDIENT
Resmethrin %
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed in
the EPA Compendium of Acceptable Uses. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in TABLE A for that use
pattern.
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3. Precautionary Statements
Manufacturing Use Product:
"This pesticide is highly toxic to fish. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans or public water unless this product is
specifically identified and addressed in a NPDES permit. Do not
discharge effluent containing this product into sewer systems
without previously notifying the sewage treatment plant
authority. For guidance contact your State Water Board or
Regional Office of the EPA.w
Outdoor Use
1. Mosquito abatement and pest control treatments at
nonagricultural sites.
"This pesticide is highly toxic to fish. Drift and runoff
from treated sites may be hazardous to fish in adjacent waters.
Consult your State's Fish and Wildlife agency before treating
such waters."
2. Other than mosquito abatement or pest control treatments
at nonagricultuaral sites.
"This pesticide is highly toxic to fish. Do not apply
directly to water or wetlands (swamps, bogs, marshes, and
potholes). Drift and runoff from treated sites may be hazardous
to fish in adjacent waters. Do not contaminate water when
disposing of equipment washwaters."
4. Restricted Use:
All products labeled for mosquito abatement and pest control
treatments at nonagricultural sites (i.e. beaches, parks,
campsites, woodlands, athletic fields, golf courses, swamps,
tidal marshes, refuse and waste sites, and municipalities) are
classified RESTRICTED USE and must bear the following
restricted-use classification:
"RESTRICTED USE CLASSIFICATION
Due to acute fish 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."
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V. !?V ;' •••"•''' •-• •• ^'iVi' -"• ','••'.•,»:'C; :.«'J, ,,'.110 •
All.products containing one or more of the pesticides -
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B.2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
2Data 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 Registration
Standard. Table B lists product-specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the
generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products. The Agency has decided that, in most cases, it will
not require the submittal of product-specific data for end-use
products at this time. Therefore, most Registration Standards
do not contain a Table C.
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B. Manufacturing use products containing this pesticide as one
Of mi i, 1 t i. n 1 «» arf.lvp i nrrroHi «T»+-e a«-« ^.,^4«^*- •(--,=
1. The data requirements listed in Table A.
2. • 'The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption,3 the data
requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
3If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the generic data exemption for generic data
concerning that active ingredient (Table A) and product-specific
data for the registered manufacturing use product you purchase
(Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required data, all
end-use producers lose the exemption, and become subject to the
data requirements in Table A.
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End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
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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 registration of products
containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having
that formulation type. These are classed as generic data, and
are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 152.85) to submit generic
data in response to a DCI notice if the registrant who supplies
the active ingredient in his product is complying with the data
request.
Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
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If you are granted a generic data exemption, you rely on the
efforts o.f 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.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply to a
registered source that does not share ownership in common with
your firm. If you choose to change sources of supply, the
Confidential Statement of Formula must identify the new
source(s) and you must submit a Generic Data Exemption
Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal or citation of the required
data not later than the date upon which current registrants of
similar products are required to provide such data. See FIFRA-
sec. 3(c)(7)(A). If you thereafter fail to comply with the
condition of that registration to provide data, the registration
may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
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D. How to comply with DCI 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 submittal. The Agency will
also require adequate assurance that the person whom you state
will provide the data is taking appropriate steps to secure it.
The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or a
mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The request
must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the consortium
will be generating or submitting.
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The Agency will assign a number to the consortium, which
should be used on all data submitted 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 DCI. 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 Development
of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must, at a
minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec. 3(c)(2)(B) in
the [name of active ingredient] Registration Standard upon terms
to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) .
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you may
qualify for this option. In order for you to avoid suspension
under this method, you may not later withdraw or limit your
offer to share in the burden of developing the data.
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_.. ....
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
requirement applies, EPA does not anticipate that many waivers
will be granted. A request for waiver does not extend the
timeframes for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data. The Agency will respond in writing to
your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required to
submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting the
requirement.
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I". frroU--:oi: . -'
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. All testing must be
conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70). Please
note, however, that certain OECD standards (such as test
duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
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.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
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You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions generally be given to conduct studies
due to submittal of inappropriate protocols. The Agency will
respond in writing to your request for protocol approval or
change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate the
data than is allowed by EPA's schedule, you may submit a request
for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future claim
that there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity or
adequacy of funding, since the Agency believes that with proper
planning these can be overcome. The Agency will respond in
writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including, but
not limited to, requirements referenced or included in this
Notice or contained in PR Notice 86-5 (issued July 29, 1986).
All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the
submittal requirement.
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J. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the registrant
is not consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale or
distribution; and
2. Demonstration that such a provision would be consistent
with the provisions of FIFRA.
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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
requirements, you must follow the same procedures as for generic
data. See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or
VI.D.6. (cancellation of registration).
Failure to comply with the product-specific data
requirements for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and
its uses. General labeling requirements are set out in 40 CFR
156.10 (see Appendix II - LABELING and SUMMARY). In addition,
labeling language specific to products containing this pesticide
is specified in Section IV.D of this Registration standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2
x 11 files. Draft labeling must indicate the intended colors of
the final label, clear indication of the front panel of the
label, and the intended type sizes of the text.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Resmethrin Registration Standard
All submittals in response to this Registration Standard are
non-fee items, including 90-day responses, protocols and waiver
requests, data, and revised labeling. Submittals must be clearly
identified as being in response to the Registration Standard.
Under no circumstances may Registration standard responses be
combined with other types of filings for which fees are
required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3) , if
applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data (See
Table B).
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c. Three copies of draft labeling, including the container
. label and any associated supplemental labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3), if
applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the generic
data exemption. If for any reason any test is delayed or aborted
so that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
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C. End Use Products containing the subject pesticide as sole
active ingredient.
1,
submit:
2.
submit:
Within 90 days from receipt of this document, you must
Generic data exemption Statement (EPA Form 8580-3), if
applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
Confidential Statement of Formula (EPA Form 8570-4).
Within 9 months from receipt of this document you must
a. Two copies of any product-specific data, if required by
Table C.
b. Product Specific Data Report (EPA Form 8580-4) , if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
D. End Use Products containing the subject active ingredient as
one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3) , if
applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
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b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the
producer after July 31, 1988.
-------
I.DATA APPENDICES
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply
to the pesticide in all products, including data
requirements for which a "typical formulation" is the
test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table c contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Prot Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food B = Terrestrial, non-food
C = Aquatic, food D = Aquatic, non-food
E = Greenhouse, food F= Greenhouse, non-food
41
-------
- TGUIDE-2
G * Forestry .; _: _______ :.: ijat •'
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
- EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such
data do not fully satisfy the data requirement. In
some cases , the Agency may possess data on one of two
required species or may possess data on one test
substance but not all. The term may also indicate that
the data available to EPA are incomplete. In this
case, when the data are clarified, or additional
details of the testing submitted by the original data
submitter, the data may be determined to be acceptable.
If this is the case, a footnote to the table will
usually say so.
EIQ - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
42
-------
TGUIDE-3
6. Must additional data be subruttfid? (Column 6). This column
.
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column e indicates that the Agency
has only -partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not
have the data, EPA will not require its submission because of
the unique characteristics of the chemical; because data on
another chemical can be used to fulfill the data requirement; or
because the data
requirement has been waived or reserved. Any such unusual
situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column t requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-In letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
43
-------
TABLE A. GENERIC DMA REQUIREMENTS FOR TOE TECHNICAL GRADE OF THE ACTIVE INGREDIENT: RESMETHRIN1.
Does EPA
have data to
Must additional
data be submitted Time Frame
Test satisfy this
Data Requirement Substance2 requirement?3
158.190 Product Qiemistry
PrOfiuc/t Identity and Composition
61-2. Description of Beginning Mater-
ials and Manufacturing Process
61-3. Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1. Preliminary Analysis of Product
Samples
Physical and Chemical Characteristics
63-2. Color
63-3. Physical State
63-4. Odor
63-5. Melting Point
63-6. Boiling Point
63-7. Density, Bulk Density or
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Specific Gravity
63-8. Solubility TGAI or PAI
63-9. Vapor Pressure TGAI or PAI
63-10. Dissociation Constant TGAI or PAI
63-11. Octanol/Water Partitioning PAI
coefficient
63-12. pH
63-13. Stability
fttlrer Reouirements:
64-1. Submittal of Samples
TGAI
TGAI
N/A
No
No
No
No
NO
No
No
No
No
No
No
No
No
No
No
N/A
Bibliographic
Citation3
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
under FIFRA Sec. For Data
3(c)(2)(B>? Sabnission
Yes4
Yes5
Yes6
Yes7
Yes7
Yes7
7n
,«, »8
7 Q
Yes7'9
Yes7
Yes7
Yes7
Yes7
Yes7
Yes7*10
Yes7
No
•
9 months
9 months
•Z months
-•'
•) months
} months
^ months
) months
^ months
) months
months
months
v months
months
• months
months
(Continued, footnotes follow).
-------
TABLE A. (Continued).
1. All currently registered technical products are also manufacturing-use products; therefore, additional
data requirements pertaining to these products are listed in Table B.
2. TGAI = technical grade of the active ingredient. PAI = purified active ingredient.
3. Not applicable. Although product chemistry data may have been submitted in the past, the ? vency 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.
4. complete information must be provided regarding the nature of the process (batch or continvMas), the
relative amounts of beginning materials anrf the order in which they are added, the chemical equations for
each intended reaction, equipment used to produce each intermediate and the final product, reaction
conditions, duration of each step of the process, purification procedures, and quality control measures. In
addition, the name and address of the manufacturer, producer, or supplier of each beginning materi-4 used in
the manufacture of each product must be provided, along with information regarding the propertied of those
materials.
5. A detailed discussion of all impurities that are or may be present at >0.1%, including nit:• ^samines,
based on knowledge of the beginning materials, chemical reactions (intended and side) in the man acturing
process, and any contamination during and after production must be submitted.
6. Five or more representative samples must be analyzed for the amount of active ingredient and each
impurity for which certified limits are required. Complete, detailed descriptions of the analytic methods
used must be submitted along with statements of their precision and accuracy. Reports of preliminary
analyses should include for each sample the identity of each ingredient for which analysis was (.'nducted,
the quantity that was found, and the mean and relative standard deviation of reported analytical results.
7. Data must be submitted on physicochemical characteristics (color, physical state, odor, melt: 3 point,
boiling point, specific gravity, solubility, vapor pressure, dissociation constant, partition co ficient,
pH, and stability) as required in 40 CFR 158.190 and more fully described in the Pesticide 2 sessment
Guidelines, Subdivision D. See Table B for additional requirements for data on physi( ihemical
characteristics of technical products that are also manufacturing-use products.
-------
TABLE A. (Continued).
Guidelines, Subdivision D. See Table B for additional requirements for data on physicochemical
characteristics of technical products that are also manufacturing-use products.
8. Data on melting point are required if the technical chemical is a solid at room temperature.
9. Data on boiling point are required if the technical product is a liquid at room temperature.
10. Data on pH are required if the test substance can be diluted or dispersed in water.
-------
TABLE A.
DMA REQUIREMENTS FOR RESMETHRIN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
frame
for
submission1
158.240 Residue Chemistry
171-2. Chemical Identity2
171-3. Directions for use
171-4. Nature of the residue
(Metabolism)
- Plants
FAIRA
(See Index)
Partially 00128626.
Yes3
Ik ncnths
171-4.
171-4.
171-4.
171-4.
171-4.
Nature of the residue
(Metabolism)
- Livestock
Residue analytical
methods
Storage stability
Magnitude of residue in
Meat/Mi iVPoultry/Bggs
Food Handling
Establishments
FAIRA and Partially
plant metabo-
lites
UGH. and Partially
metabolites
1EP and No
metabolites
TGAI or plant No
metabolites
FAIRA and/or Partially
plant metabo-
lites
00159388.
00077182. 00123575.
00129282.
N/A.
N/A.
00123575. 00129282.
Yes4,5
Yes6,7
Yes8
Reserved9
Yes"*,11
18 months
B
15 months
15 months
18 ontns
ft*
12 healths
l. Data must be submitted within the indicated time frame, based on the date of this Guidance Docur-nt.
-------
TABLE A. Footnotes (Continued).
2. The same chemical identity data are required as under 158.150-158.190, with emphasis on impurities that
could constitute residue problems. Refer to Product Chemistry Data Requirements tables.
3. The Agency has assumed that the metabolism/degradation of a pesticide in food handling establislwnts
will result in metabolites similar to those in growing plants. The requirements for degradation studies to
support the established food additive tolerance for residues resulting from treatment of food handling
establishments are detailed in footnote 11.
4. Metabolism studies utilizing ruminants and poultry. Animals must be dosed orally for a minimum f 3
days with 2-furan-labeled [14C]resmethrin and carboxy-labeled [14C]resmethrin, in separate tests, at levels
sufficient to make residue identification and quantification possible. Eggs must be collected twia a day
during the dosing period. Animals must be sacrificed within 24 hours of the final dose. The distri jtion
and identity of residues must be determined in eggs, liver, kidney, muscle, and fat. Samples from ft ase ;
studies must also be analyzed using proposed enforcement methods to ascertain that the methods are capable
of adequately recovering and identifying all residues of toxicological concern. , i
5. Data depicting the nature of resmethrin residues in swine are also required if the required met* >lism
studies with ruminants and poultry reveal that the metabolism of resmethrin in these animals differs from
that in rats.
6. Representative l-od samples bearing residues of resmethrin must be analyzed by multiresidue prot~ »ls I,
II, III which are available from the National Technical Information Service under Order No. PB 20373 AS.
7 The results of a successful confirmatory trial of the Penick Corp. GLC method designated no. 104'
(revised), conducted by an independent laboratory, must be submitted for representative food samples
Results of at least one set of samples per caimodity (a total of six samples, including two control . mples,
two control samples fortified at the tolerance level, and two control samples fortified at 2-5 times he
tolerance level) must be submitted. No more than three sets of samples per conmodity may be tested r:
achieve successful recovery rates of 70-120% with negligible interference compared to the establish*
tolerance(s). For additional details of data requirements, refer to PR Notice 88-5, Tolerance Btforc nent
Methods - Independent Laboratory Confirmation by Petitioner.
8 Storage intervals and conditions must be supplied for all required and previously submitted data 3r
?ood product sampies. This information must be accoipanied by data depicting the percent decline in i sidues
o^esmethrin^nderthe storage conditions and for the intervals specified. Fortified samples of
C^ r^resentative food conmodities must be analyzed iimediately after fortification and again after stoi ie
-------
TMLE A. Footnotes (Continued).
intervals that are equivalent to those reflected in all previously submitted and currently requested data
The chosen intervals must allow for unforseen delays in sample storage. For additional guidance on
conducting storage stability studies, the Registrant is referred to an August 1987 Position Document on the
Effects of Storage on Validity of Pesticide Residue Data available from NITS under order no. F688U2362/AS.
9. Following receipt and evaluation of the required plant metabolism/degradation and animal metabolism
data, storage stability data, and residue data for feed items, specific data requirements for livestock
feeding studies will be determined.
10. Data depicting the nature of the residue in representative food products from typical food ha tiling
establishments resulting from known contamination by [14C] resmethrin. Tests conducted must repres it the
range of normal heating and processing procedures following fortification with the [14C]resmethrir it
typical stages where contamination resulting from treatment of the establishment premises might oc •- ir.
Characterization of residues must be conducted in samples representing the range of normal shelf 3 . : e for
the food products. Alternatively,, adequate characterization of residues in plant metabolism studi •; may be
conducted. Should the studies of the nature of the residue reveal the presence of degradation products of
concern other than resmethrin per ss, analysis for such residues must also be included in residue
11. Data depicting the magnitude of residues of concern in food products resulting from the appliv it ion of
normal and exaggerated rates of representative SC/L and EC formulations of resmethrin in food serv.-«, food
manufacturing, and food processing establishments (two representative types of each food handling
establishment as listed in Table 1 of Subdivision O of the Pesticide Assessment Guidelines). Cone ±ed
tests must be representative examples of worst-case scenarios for potential residue contamination : food
products which might include, but are not limited to, some of the following: (i) particulate aeros " contact
with packaged products or unwrapped fresh produce present and/or on display at the time of resmetlu ji
treatment- (ii) contact of packaged foods with treated surfaces, such as flour sacks stacked on treated
floor surfaces in storage areas; (iii) accidental treatment of food work surfaces and subsequent c ftact of
food before surfaces are cleaned; (iv) treatment occurring near stacks of new or cleaned product c.>itainers
that are filled without being cleaned; and (v) distribution of residues in continuous process fooc
from treatment of ends and tailings, conveyor lines, boots, etc. , when operation is shu. down.
tuations in grocery stores and restaurants must include a representative range of foods .«* as
Eaked cereal products, raw and cooked meats, and fresh fruits and vegetables.
-------
Table A
Generic Data Requirements for Resmethrin
H^nSa to Mist Additional —
Data Re*™, *ZZ~ JS™, ^ftJE «2!S?»* ™*™*™°* WS
Sec. 158.290 Environnrajtal Fate
DfiqrafVfit ion -^turtles - Lab
161-1 - Hydrolysis TGAI or FAIRA B,D,E, No
F,H,I
Fhotodeciradax ion
161-2 - In Water TGM or FAIRA B,D No
161-3 - On Soil TGAI or FAIRA - No
161-4 - In Air TGAI or FAIRA - No
MPtflfrolisro SfVKliflS - Lab
162-1 - Aerobic Soil TGAI or FAIRA B,E,F No
162-2 - Anaerobic Soil TGAI or FAIRA - No
162-3 - Anaerobic Aquatic TGAI or FAIRA D No
162-4 - Aerobic Aquatic TGAI or FAIRA D No
ftobilit,y Studies
Yes c .nonths
Yes g months
No
No
Yes r months
No
Yes^/ 2" months
Yesi/ 2. months
LH 163-1 - Leaching and
£3 Adsorpt ion/Desorpt ion
TGAI or FAIRA B,D,E,F,H No
Yes
1 months
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Data Requirement
Sec. 158.290 Environmental Fate
163-3 - Volatility (Field)
Dissipation S.tVK3l€? ~ Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Test
Substance
(cont'd)
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Use Satisfy This
Patterns Requirement?
E,F No
B,H No
D No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Yes
Yesl/
No
No3/
Yimeframe
Er Data*/
(mission
27 months
27 months
Tank Mixes
164-5 - Soil, Long-Term
TEP
No
Reserved^/
Aroimulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
PAIRA
TEP
TEP
TGAI or PAIRA B,D
No
No
No
No
No
No
No
Yes
12 months
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Test
Use
Data Requirement
Sec. 158.390 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation
Sec. 158.440 Sorav Drift
202-1 Drift Field Evaluation
202-1 Drift Size Spectrum
TGAI
TIM
TGM
TiAI
TGAI
TGAI
B
B
Does EPA
Have Data to
Satisfy This
No
No
No
No
No
No
Bibliographic
citation
Hist Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
'
Reserved^/
Reserved^/
Ln
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Sec. 158.290 Environmental Fate
Footnotes
I/ The aquatic data requirement is being imposed for the use of resmethrin on beaches, marsh lands, etc.
2/ Resmethrin does not have a terrestrial food use to require field volatility data.
J/ This requirement is not being imposed at the present tune.
4/ Tliis data requirement is deferred pending evaluation of the aerobic soil metabolism, leaching and dissipation data.
5/ This data requirement is reserved pending the evaluation of the fish accimulation study.
fi/ Available toxicological data do not trigger human exposure concerns under present Qiidelines.
I/ Spray drift data requirements are reserved pending evaluation of the outstanding invertebrate toxicity >ta.
cn
-------
Table A
Generic Data Requirements for Resmethrin
Data
158.:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Subcl
82-1
T
Reoui, rejnerit Su
140 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
ironic Testing
- 90-Day Feeding -
Rodent
M-Mn-rrvlent
Does EPA
Have Data t<
est use Satisfy Thi.-
TGAI All No
TGAI All No
TGAI All Yes
TGAI All Yes
TGAI All Yes
TGAI All Yes
TGAI No
TGAI A,E No
TGAI A,E No
Must Additional
3 Data Be Submitted Timeframe
s Bibliographic Uhder FIFWV Section For Data
? Citation 3{c)(2)(B)? ^llmi'rfiifln
00123346 Yes ^ months
00123347
00123490
00133890 Yes * months
00158477 No
00028466 No
00028466 No
00158478 NO
Nol/
No2/
No2/
CD
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Data Requirement
158.340 Toxicology
SuJDciirQnic Testing (cont'd)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation - Rat
82-5 - 90-Day Neurotoxicity -
Test
Substance
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data to
Use Satisfy This
Patterns Requirement?
All No
No
E,F,I Yes
Yes
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3 (c ) ( 2 ) (B) ?
Yes
Yes3/
00158476 NO
00025552, 00025553, No
Timeframe
Tor Data
12 months
15 months
Rat
Chronic Testing
83-1 - Chronic Testing
-Rodent
-Dog
TOM
TGM
A,E
A,E
Yes
Yes
00025554
00085870, 00108828
00147770, 00147771,
00158495
00157961
NO
83-2 - Qncogenicity
-Rat
-Mouse
83-3 -Teratogenicity
-Rat
TCM
TGM
A,E
A,E
All
Yes 00085870, 00108828,
00147770, 00147771,
00158495
Yes 00083319
Yes 00028453
NO
No
-------
U1
ON
Table A
Generic Data Requirements for Resmethrin (cont'd)
Test
Use
Does ETA
Have Data to
Satisfy This
158.340 Toxicology
Chronic Testing (cont'd)
83-4 - Reproduction - Rat
Mutagenicitv Testing
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for Data
^ «- -«• ion 3(cH2)(B)?- Submission
TGAI
A,E
Yes 00081276, 00124308
00124122, 00107885
84-2 -
84-2 -
84-4 -
Special
85-1 -
Gene Mutation
Chromosome Aberration
Other Mechanisms of
Mutagenicity
Testing
General Metabolism
TGAI
TGAI
TGAI
EM or
FAIRA
All
All
A,B
A,E
No 00057853
No
No
No
Yes
Yes
Yes
Yes
months
I months
l months
I months
I/ Since resmethrin is not an organophosphate, this study is not required.
2/ The availability of acceptable chronic feeding studies in rats and dogs eliminates the need to require chese
subchronic feeding studies.
3/ 90-Day subchronic dermal studies are required because veterinary use products may result in daily expc ire to
hurans (i .e. Tninal care taJniciaTS vfto dip an^tr stHipso animals).
4/ Additional information regarding historical control data for spontaneous development of thyroid tunors ias been
requested of the registrant as of May 1988.
-------
Table A
Generic Data Requirements for Resmethrin
Test
Substance
Does EEA Have
Data to Satisfy Most Additional
This Require- Data Be Submitted Timeframe
Use ment? (Yes, Bibliographic Under FIFRA section tor Data
Pattern No. Partially) Citation 3(c)(2)(B)? , Sutmission
Sec. 1SB.490 -Mi
Avian and Manualian Testing
71-1 -Avian Acute Oral Toxicity
- Upland game bird TGAI
71-2 - Avian Dietary LC5o
- Upland Game Bird TGAI
- Waterfowl
B,D,G
Yes
B,D,[F,I]*/G No
TGAI B,D,[F,I]1/G No
00160000
NO
Yes2/
Yes2/
i months
9 months
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Actual Field Testing
for Birds and
Mammals
TGAI B,D,G
TGAI B,D,G
TEP B,D,G
Yes
No
No
Yes*/
I months
cn
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Does EPA Have
Data to Satisfy Must Additional
This Require- Data Be Submitted t&neframe
Test Use ment? (Yes, Bibliographic Under FIFRA Section For Data
Substance Pattern No. Partially) Citation 3JcJ
esin
72-1 - Freshwater Fish LC50
- Warmwater TGAI
TEP
- Coldwater TGAI
TEP
72-2 - Freshwater
Invertebrate LC50 TGAI
TEP
72-3 - Estuarine and Marine TGAI
rh-nani
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Does EPA Have
Data to Satisfy Must Additional
This Require- Data Be Submitted Wireframe
Test Use ment? (Yes, Bibliographic Under FIFRA Section fbr Data
Sec. 158.490 -Wildlife and Asiatic Organisms
-marine/estuarine TGAI B,D,G No Reservedlfl/
Fish
Invertebrates
72-5 Fish Life Cycle TGAI B,D,G No
72-6 Aquatic Organism
Accumulation TGAI B,D,G No
72-7 Simulated or actual
Field Testing -
Aquatic Organism TEP B,D,G No
Sec. 158.540 Plant Protection
121-1 Target Area
PhvtQtoxicitV TEP B,D,G No
c/i
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
Data Requirement
Sec. 158.540 -Wildlife and Adi
Non-Taraet Area Phytotoxicitv
Tier I
122-1 Seed Germination/
Seedling Emergence
122-1 Vegetative Vigor
122-2 Aquatic Plant Growth
Tier II
123-1 Seed Germination/
Seedling Emergence
123-1 Vegetative Vigor
123-2 Aquatic Plant Growth
Tier III
124-1 Terrestrial Field
124-2 Aquatic Field
Test
latic Orcranis
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
Use
Pattern
(TV?
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
Does EPA Have
Data to Satisfy
This Require-
ment? (Yes,
No. Partiallv)
No
No
No
No
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(cH2)(B)?
Yesi^/
Yesl^y
Yes!*/
Reservedlsy
Reservedly/
Reserved^/
No*/
Nb5/
Tfetneframe
Fc-r Data
.^-bmission
V ?nonths
* months
f months
O
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
I/ Required to support the manufacturing use product that is reformulated into end use products.
2/ Required for all registrations with outdoor uses.
3/ The wild mammal test is not presently a requirement.
4/ Avian reproduction studies on bobwhite and mallard are required for technical Resmethrin because the mosquito use
would subject birds to repeated exposure during the breeding season.
5/ Not currently a requirement.
fi/ Tests using the soluble concentrate liquid, either 4%, 1.51 Ib/gal, or 3.34 Ib/gal for mosquito abat ^nent are
required to support the mosquito and other pest control uses at aquatic sites.
2/ Acute aquatic toxicity studies on aquatic invertebrates using the formulated product may be required .hen the
product will be introduced directly into water, or when the maximum expected environmental concentratior (MEET) or
estimated environmental concentration (EEC) exceeds the I£5p of the technical material. The presently r- istered uses
for mosquito abatement include direct application to shorelines, beaches, tidal marshes, marsh lands, nt\ shy areas,
stagnant pools, and swamps. Also, the lowest labeled application rate for mosquito abatement results in < i EEC
greater than the LC50 for fish—the only aquatic organism with toxicity data on file.
-------
Table A
Generic Data Requirements for Resmethrin (cont'd)
fi/ Acute toxicity studies of the technical grade material are required for hazard evaluation, because of existing
registration for mosquito control on and adjacent to marine and estuarine sites.
3/ Acute toxicity of soluble concentrate liquid, either 4%, 1.51 Ib/gal, or 3.34 Ib/gal registered for moscuito
abatement are required for hazard evaluation because of existing registration for mosquito control on and adjacent
to marine and estuarine sites.
Chronic toxicity studies using marine/estuarine fish and invertebrates will be reserved pending the ov v :ome of
the lower tiered tests on marine/estuarine species, the freshwater early life stage, and the 21 day Daphn: '-. life-
cycle toxicity study.
H/ Deferred to Environmental Fate requirements.
12/ Testing of the soluble concentrate liquid, either 4%, 1.51 Ib/gal, or 3.34 Ib/gal for mosquito abatemfVc are
reserved pending the results of acute testing.
13/ All Tier I data on Nontarget Area Fnytotoxicity are required for pesticides used in forest and natural
grasslands.
Aquatic Plant Growth data are required as special testing (Section 70-1) for the mosquito abatement uj because
that use involves application of resmethrin to aquatic habitats.
I5/ Reserved pending results of Tier I studies.
-------
Table A
Generic Data Requirements for Resmethrin
Test
Use
Does EPA Have
Data to Satisfy Mist Additional
This Require- Data Be Submitted Timeframe
ment? (Yes, Bibliographic Under FIFRA Section for Data
NO. Partiallvi Citati
Sec. 158.590 Nontarget Insects
'T ~
141-1 - Honey Bee Acute TGAI B
Contact LD50
141-2 - Honey Bee - Toxicity TEP B
Residues on
Foliage
141-4 - Honey Bee Subacute Reserved^/
Feeding Study
141-5 - Field Testing for TEP B
pollinators
MTylTARGETT INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect
Life Cycle Study
142-3 - Sinulated or
Actual Field
Testing for
Aquatic Insects
Reserved^/
Reserved^/
Reserved^/
Yes
No
00142655
NO
Yesl/
15 months
No
-------
Table A
Generic Data Requirements for Resmethrin
EPA Hist Additional
Have Data to Data Be Submitted Timeframe
Test Use Satisfy This Bibliographic Under FIEWV Section For Data
Data Requirement Substance Patterns Requirement? Citation He) (2KB)? Mmlsslor
NJOTARGET INSECT TESTING ;
AND PARASITES
143-1 Reserved*/
through
143-3
•"158.590 - Nontaraet Insects Footnotes
I/ As data from acute contact test indicate high toxicity, residual toxicity data are required.
2/ Reserved pending development of test methodology.
J/ Data reviewed to date do not indicate a need for field testing.
4/ Reserved pending decision whether the data requirement should be established.
-------
TABLE B. GENERIC DMA REQUIREMENTS FOR RESMEIHRIN M*WUFACnjRING-USE PRODUCTS.
Does EPA*
have data to
Test satisfy this Bibliographic
Data Requirement Substance1 requirement?2 Citation2
158.190 Product Chemistry
Product Identity and Composition
61-1. Product Identity and Disclosure
of Ingredients
61-2. Description of Beginning Mater-
ials and Manufacturing Process
61-3. Discussion of Formation of
Impurities
Analysis and Certifirfttl^" of PrwHirt-
Ingredients
62-1. Preliminary Analysis of Product
Samples
62-2. Certification of Ingredient
Limits
62-3. Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2. Color
63-3. Physical State
63-4. Odor
63-7. Density, Bulk Density or
Specific Gravity
63-12. pH
62-14. Oxidizing or Reducing Action
62-15. Flamnability
63-16. Explodability
63-17. Storage Stability
63-18. Viscosity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must additional
data be submitted Time Frame
under FIFRA Sec. Far Data
3(0 (2) (B)? . ^omission
Yes3
Yes4
Yes5
Yes6
*«,
Yes8
Yes9
*«»
Yes9
*«,
Yes9.10
Yes9
Yes9'11
Yes9.12
Yes9
Yes9-13
•
9 months
) months
9 months
ii months
:i months
>. months
i months
i months
i months
a months
i months
i months
••> months
i months
months
M months
Ul
(Continued, footnotes follow)
-------
TABLE B. (Continued).
Data Requirement
63-19.
63-20.
Miscibility
Corrosion Characteristics
Test
Substance1
HP
MP
Does EPA
have data to
satisfy this
requirement?2
No
No
Citation2
N/A
N/A
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)?
Yes9'14
Yes9
T?ime Frame
WOT Data
Submission
9 months
15 months
Other Requirements;
64-1. Submittal of Samples
N/A
N/A
N/A
No
3
1. MP = manufacturing-use product. Since all MP are technical grade active ingredients, generic data
required by Table A will suffice to meet the requirements of Table B.
2 Not applicable. Although product chemistry data may have been submitted in the past, the .^jency has
determined that these data must be resubmitted for each pesticide. New requirements have been Produced
and previously submitted data must be updated. Therefore, bibliographic citations for the old dafc* are not
applicable.
The product name, chemical name (Chemical Abstracts Index of Nomenclature or otherwell defi c-!d name),
concentration, certified limits, Chemical Abstracts Service (CAS) Registry Nunber, and - irpose of
and each intentionally added inert must be provided for each manufac iring-use
pper certified limit must also be provided for each impurity or group of Parities
wch i- li? is required. The information on ingredient limits must be submitted c , EPA Form
8570-4 (Rev. 2/85).
materials.
-------
TABLE A. (Continued).
1. All currently registered technical products are also manufacturing-use products; therefore, additional
data requirements pertaining to these products are listed in Table B.
2. TGAI =:technical grade of the active ingredient. FAI = purified active ingredient.
i
3. Not applicable.. Although product chemistry data may have been submitted in the past, the Agency has
deteifinined that these data must be resubmitted for each pesticide. New requirements have beeft introduced
and previously submitted data must be updated. Therefore, bibliographic citations for the old <3ata are not
applicable.
i
4. Complete information must be provided regarding the nature of the process (batch or cant. >uous), the
relative amounts of beginning materials and the order in which they are added, the chemical e ations for
each intended reaction, equipment used to produce each intermediate and the final product, reaction
conditions, duration of each step of the process, purification procedures, and quality control m jsures. In
addition, the name and address of the manufacturer, producer, or supplier of each beginning mate- al used in
the manufacture of each product must be provided, along with information regarding the propert. s of those
materials.
i
5. A detailed discussion all impurities that are or may be present at >0.1%, including nitrosai. nes, based
on knowledge of the beginning materials, chemical reactions (intended and side) in the m oifacturing
process, and any contamination during and after production must be submitted.
6. Five or more representative samples must be analyzed for the amount of active ingredie : and each
impurity for which certified limits are required. Complete, detailed descriptions of the analytl al methods
used i must be submitted along with statements of their precision and accuracy. Reports of ...oreliminary
analyses should include for each sample the identity of each ingredient for which analysis wa- conducted,
the quantity that was found, and the mean and relative standard deviation of reported analytical results.
i
!
7. Data must be submitted on physicochemical characteristics (color, physical state, odor, me ing point,
boiling point,'specific gravity, solubility, vapor pressure, dissociation constant, partition coefficient,
pH, ;and stability) as required in 40 CFR 158.190 and more fully described in the Pesticidt Assessment
Guidelines, Subdivision !D. See Table B for additional requirements for data on phy—cochemical
characteristics of technical products that are also manufacturing-use products.
-------
ON
CO
TABLE B. (Continued).
12. Data are required if the product contains any potentially explosive ingredients.
13. Data on viscosity are required if the product is a liquid.
14. Data on miscibility are required if the product is an enulsifiable liquid and is to be diluted with
petroleum solvents.
-------
Table B
Product Specific Data Requirements for Manufacturing Use Products Containing Resmenthrin
Section
Data Reouirement S
JISB.
81-1
81-2
81-3
81-4
81-5
81-6
.340 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
Does EPA
Have Data t(
Test Use
For Data
UfrfitVfffVTft Patterns Requirement'
MP
MP
MP
MP
MP
MP
All No
All No
All Yes
All Yes
All Yes
All Yes
Must Additional
> Data Be Submitted Timef rame
Satisfy This Bibliographic , Under FIFRfl
> Citation 3(c)(2)(B)? ^mission
Yes*/ 9 >3nths
Yesl/ 9 ronths
00158477 NO
00028466 NO
00028466 No
00158478 NO
I/ Acceptable data derived from acute toxicity tests conducted on the TGAI will satisfy this requirement.
VO
-------
II. LABELING APPENDICES
70
-------
SUMMARY- 1
T CONTENTS
, . _
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156. 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.,11 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 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment 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 156.10(f)]
71
-------
SUMMARY- 2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front nanpi , The i n<7i'«»H i «T^* e e««-oi4-«»r<.T»*- — .--*•
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
156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. 'CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(h)(l)(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.
[40CFR 156.10(h) (1) (i)].
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON.
[40 CFR 156.10(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 156.10(h)(l)(iii)]
72
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is
re^iit-iS -•-../ -;;*•% t'.'?*-V : -X; . -•• •-' ( ^'-'.c -..-.. ,.-, _. ^ ^^
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(l)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(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 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
73
-------
SUMMARY- 4
The Regulatory Position and Rationale states whether
products containing this active inorpri|an+- =»ro oiar<^ **
'
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
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162. 11 (c). You will be notified
of the Agency's classification decision.
Classification I ng Reuirements
If your product has been classified for restricted use, the
following label requirements apply:
l. 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 156. 10(h) (1) (iv) .
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons for
restriction if specified in Section I). If use is
restricted to certified applicators, the following
statement is required: "For retail sale to and use
only by Certified Applicators or persons under
their direct supervision and only for those uses
covered by the Certified Applicator's
Certification. "
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
74
-------
SUMMARY-5
b. You may delete all restricted uses from your
la'-.ol vu-4 .• * " ' ";. ." \?i-'q '.•'•-> >
unrestricted uses.
c. You may "split" your registration, i.e.,
register two separate products with identical
formulations, one bearing only unrestricted uses,
and the other bearing restricted uses. To do so,
submit two applications for reregistration, each
containing all forms and necessary labels. Both
applications should be submitted simultaneously.
Note that the products will be assigned separate
registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
75
-------
SUMMARY- 6
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the
directions for use. This heading must be set in the same type
sizes as required for the child hazard warning. Refer to
Appendix II, STOR, PEST/DIS, and CONT/DIS to determine the
storage and disposal instructions appropriate for your
products .
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
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.
76
-------
SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
•7
7A
7B
1
LABEL FT.FMFl\rr
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
wajmino)
Signal word
APPLICABILITY
OF REOUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
filiAmit ajrssL
All products
All products
All products
i
PIACEMPNT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front
panel or end
of IflJpel text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Immediately
following
product, najftft
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
WSUmino
COMMENTS
If registrant is not the producer, must
be qualified by "Packed fc . . . ,"
"Distributed bv . . . " et'-
May be in metric units in < Idition to
U.S. units.
Must be in similar type si -^ and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel witL other text
on the panel.
f
All front panel precautionary statements
must be grouped together, i 'Sferably
blocked.
Note type size requirements
Note type size requirements
-------
SUMMARY-8
REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
o
8A
8B
TMFT. FTJFMFWT
Skull & cross-
bones and word
POISCN (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
apinfl^s
Environmental
Hazards
APPLICABILITY
OF REDUIREMENr
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
EWwEHENT
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
i 1
J]N LABFT.
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headi- js in
8A, SB, and 8C; preferably slocked.
Must be preceded by appropriate signal
word.
Environmental hazards inclu - bee
caution where arolicable.
-------
SIM1ARY-9
LABELING REOUIRB
(cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
LABEL Fr:FMFNT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
j APPLICABILITY
! OF REQUIREMENT
{All pressurized
'products, others
{with flash
j points under
!l50PF
|All restricted
{products
i
i
{All products
i
i
i
i
i
i
i
i
{PR Notice 83-2
{or as determined
by the Acrency
JAll products
i
i
i
i
i
i
i
{All products
i
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
CdVMENTS
Refer to Appendix II guidfr
PHYS/CHEM
Includes a statement of tJrct terms of
restriction. The words "F ^JTRICTED USE
Pt&ilUJjti" must be same ty a size as
sicmal word.
Required statement is:
HIt is a violation of Federal law
to use this product in i manner
inconsistent with its ^.ibeling."
Must be set apart and clear'.y distin-
guishable from other direer'ons
for use.
Refer to Appendix II guide". STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well aa U.S. units
-------
Criteria
PHYSICAL-CHEMICAL HAZARDS
Recruired Label Statement
I. Pressurized Containers
. .
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.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
80
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
AIT pTO'^"r"t-'S f-r tt .— --—.--- ;- , j-,. _i , » ,. ' - ' ,* i-ft' -.-( "•;... " }
about, sioidge ana tiisposai. 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.
81
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed be low rnni-q-in *-ne e^-"-*- ..~^
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 Toxic ity 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."
82
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. DOiUcoLic use pioducts must bear one o± the following
container disposal statements:
Container Type
Statement
[Non-aerosol products |Do not reuse container (bottle, can, jar).
!(bottles, cans. iars)!Rinse thoroughly before discarding in trash.
i
i
Non-aerosol products |Do not reuse bag. Discard bag in trash.
(baas)
[Aerosol products
[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,
!stav out of smoke.
Glass containers
[Triple rinse (or equivalent). Then dispose
[of in a sanitary landfill or by other
!approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
[particles.
equipment.
Empty residue into application
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.
i
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.
83
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84
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Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
Citations Of st\"\ c^nrHoe; r-/->rtp i Ae*re*r^ rp1 «'7?r;t by T^"*1 ~ ~~ ~~~s "~ ":"
tii« ^w--.w-«.i^ OiiCi cCiivJivxdluiio ;bi-ti<-c;ci «= j.aewii6ie in tue btanaard.
Primary sources for studies in this bibliography have been the
body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other
sources including the published literature, in those instances
where they have been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to
identify documents at a level parallel to the published article
from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes
of review, and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic documents
and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or MRID,
number. This number is unique to the citation, and should be used
at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify
volumes of submitted studies; see paragraph 4(d)(4) below for a
further explanation. In a few cases, entries added to the
bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for certain
special needs.
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
identified, the Agency has shown an identifiable
laboratory or testing facility as author. As a
last resort, the Agency has shown the first
submitter as author.
85
-------
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
the document. When the date appears as (19??),
the Agency was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to
the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received. "
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by. " When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the
volume in which the original submission of
the study appears. The six-digit accession
number follows the symbol "CDL," standing for
"Company Data Library." This accession
number is in turn followed by an alphabetic
suffix which shows the relative position of
the study within the volume. For example,
within accession number 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
86
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
rival. \ >h- • ''>.''. I.-.. cl *•'•'•'• •''•"ta £."•* ':o---
Registrations Under the Resmethrin Standard
MRID Citation
00025552 Schwartz, C.S. ; Becci, P.J.; Parent, R.A.; et al. (1979) Report:
Evaluation of the Neurotoxic Effects of SBP-1382 in Albino
Rats—Phase 1: FDRL Study t 6067. Includes method dated Jul 2,
1979. (Unpublished study including letter dated Nov 28, 1979
from R.W. Fogleman to B.B. Brown and Maarten devries, received
Dec 19, 1979 under 432-487; prepared by Food and Drug Research
Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J. ;
CDL:241501-B)
00025553 Cox, G.E.; Becci, P.J.; Parent, R.A.; et al. (1979) Supplementary
Report for Evaluation of the Neurotoxic Effects of SBP-1382 in
Albino Rats—Phase I: FDRL Study # 6362. (Unpublished study in-
cluding letter dated Nov 28, 1979 from R.W. Fogleman to B.B.
Brown and Maarten L. derVies, prepared by Food and Drug Research
Laboratories, Inc., received Dec 19, 1979 under 432-487; submit-
ted by Penick Corp., Lyndhurst, N.J.; CDL:241502-B)
00025554 Schwartz, C.S.; Becci, P.J.; Parent, R.A.; et al. (1979) Report:
Evaluation of the Neurotoxic Effects of SBP-1382 in Albino Rats:
Phase II: FDRL Study # 6068. (Unpublished study including let-
ter dated Nov 28, 1979 from R.W. Fogleman to B.B. Brown and
Maarten L. deVries, received Dec 19, 1979 under 432-487; pre-
pared by Food and Drug Research Laboratories, Inc., submitted by
Penick Corp., Lyndhurst, N.J.; CDL:241503-B)
00028453 Machi, R.A.; Kam, C.; Gallo, M.A.; et al. (1979) Teratologic Evalu-
ation of SBP-1382 Technical in the Albino Rat: Snell Project #
2054-066. (Unpublished study received Jan 23, 1980 under 432-
487; prepared by Booz, Allen & Hamilton, Inc., submitted by Pen-
ick Corp., Lyndhurst, N.J.; CDL:241765-A; 241766; 241768;
241769; 241770)
00028466 Weeks, M.H.; Leland, T.M.; Boldt, R.E.; et al. (1972) Toxicological
Evaluation of Pyrethroid Insecticide (5-Benzyl-3-furyl) methyl-
2,2-dimethyl-3-(2-methylpropenyl) eyelopropanecarboxylate (SBP-
1382):. Edgewood Arsenal, Md.: U.S. Army Environmental
Hygiene Agency. (Special study no. 51-127-71/72; also in unpub-
lished submission received Jul 25, 1979 under 432-547; submitted
by Penick Corp., Lyndhurst, N.J.; CDL:240934-A)
87
-------
OFFICE OF PESTICIDE PROGRAMS
Lu be Irai. u uj. ti«s jL»d.»e
Registrations Under the Resmethrin Standard
MRID Citation
00029002 Becci, P. J. ; Knickerbocker, M. ; Parent, R.A. (1979) Teratologic
Evaluation of SBP-1382 Technical in Albino Rabbits: FDRL Labora-
tory No. 6288. (Unpublished study including letter dated Jan
14, 1980 from R.W. Fogleman to Maarten L. deVries, received Jan
23, 1980 under 432-487; prepared by Food and Drug Research Labo-
ratories, Inc., submitted by Penick Corp., Lyndhurst, N.J.; CDL:
241800-A)
00057853 Brusick, D.J. (1977) Mutagenicity Evaluation of SBP-1382 Technical:
LBI Project No. 2683. Final rept. (Unpublished study received
Apr 25, 1977 under 432-432; prepared by Litton Bionetics, Inc.,
submitted by Penick Corp., Lyndhurst, N. J. ; CDL:230265-A)
00077182 Furmauer, D. (1980) GLC Procedure for the Determination of Res-
methrin (SBP-1382) Residues in Food Products. Procedure no.
1047 dated Nov 14, 1980. (Unpublished study received Jun 29,
1981 under 432-547; submitted by Penick Corp., Lyndhurst, N. J. ;
CDL:245420-A)
00081276 Schwartz, C.S.; Gephart, L. ; Becci, P. J. ; et al. (1979) The Evalu-
ation of the Effects of SBP-1382 following Dietary Administra-
tion through Three Generations in Spr ague-Daw ley Rats: Labora-
tory No. 5739. (Unpublished study received Aug 30, 1979 under
432-487; prepared by Food and Drug Research Laboratories, Inc.,
submitted by Penick Corp., Lyndhurst, N. J. ; CDL: 240984-A)
00083319 Knickerbocker, M. ; Cox, G.E. ; Parent, R.A. (1979) Evaluation of
Dietary Administration of SBP-1382 in CD-I Outbred Albino Mice
over an 85 Week Period: Laboratory No. 5270. Final rept. (Un-
published study received Aug 14, 1979 under 432-487; prepared
by Food and Drug Research Laboratories, Inc., submitted by
Penick Corp., Lynhurst, N. J. ; CDL: 239853-A; 238954; 238955;
238956; 238957)
00085870 Thompson, S.W. (1981) A Lifetime Evaluation of the Dietary Adminis-
tration of SBP-1382 to Wistar Albino Rats: Laboratory No. 5271.
(Unpublished study, including letters dated Mar 26, 1980 from
E.F. Mace to Maarten De Vries, May 13, 1981 from F.D.R. Gee to
Maarten L. De Vries, Aug 17, 1981 from M.A. Gallo to Emily F.
Hedal and Nov 9. 1981 from M.L. De Vries to Franklin D.R. Gee,
received Nov 10, 1981 under 432-487; prepared by Food and Drug
Research Laboratories, Inc., submitted by Penick Corp., Lynd-
hurst, N.J.; CDL:246214-A)
'88
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
,
Registrations Under the Resmethrin Standard
MRID Citation
00107885 Stevens, K. (1978) The Evaluation of SBP-1382 following Dietary
Administration through One Generation in Sprague-Dawley Rats:
Laboratory No. 5458. (Unpublished study received Aug 3, 1981
under 432-487; prepared by Food and Drug Research Laboratories,
Inc., submitted by Penick Corp., Lyndhurst, NJ; CDL: 245851-A;
245845; 245846; 245847; 245848; 245849; 245850; 245852)
00108828 Becci, P.; Hess, F. ; Thompson, S. (1982) A Lifetime Evaluation of
the Dietary Administration of SBP-1382 to Wistar Albino Rats:
FDRL Study No. 5271. (Unpublished study received May 27, 1982
under 432-487; prepared by Food and Drug Research Laboratories,
Inc., submitted by Penick Corp., Lyndhurst, NJ; CDL:247579-A)
00123346 Abbott, D. (1968) Acute Oral Toxicity — Rats: [SBP-1382]:
Lab. No. 69511-1. (Unpublished study received Oct 1, 1968 under
432-432; prepared by La Wall and Harrisson Research Labora-
tories, Inc., submitted by Penick Corp., Lyndhurst, NJ; CDL:
003307-E)
00123347 Abbott, D. (1968) Acute Oral Toxicity— Rats: [SBP-1382]:
Lab. No. 68327. (Unpublished study received Oct 1, 1968 under
432-432; prepared by La Wall and Harrisson Research Labora-
tories, Inc., submitted by Penick Corp., Lyndhurst, NJ; CDL:
003307-F)
00123490 Abbott, D. (1968) Acute Oral Toxicity — Rats: L & H 69255. (Unpub-
lished study received Jul 26, 1968 under 432-433; prepared by
La Wall and Harrisson Research Laboratories, Inc., submitted
by Penick Corp., Lyndhurst, NJ; CDL:050045-D)
00123575 Penick Corp. (1979) Method and Test Results: [SBP-1382]. (Compila-
tion; unpublished study received Feb 28, 1979 under 432-547;
CDL:237712-A)
00124122 Penick Corp. (1979) Reproduction and Lactation Summary and Individ-
ual Litter Tables: [E Basal Diet (Control)!: FDRL Study 5739.
(Unpublished study received Aug 3, 1981 under 432-487; CDL:
245849-A; 245850; 245851)
89
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OFFICE OF PESTICIDE PROGRAMS
T«"pT>7vrn-rr>M 'I'T'T^Tp^P.D PTPT
i-u be jfart 01 tue Data case 5uppOi.Lj.iiy
Registrations Under the Resmethrin Standard
MRID Citation
00124308 Norwood, T. (1981) A Statistical Analysis of the Effects of Dietary
SBP-1382 on Three Generations of Sprague-Dawley Rats. (Unpub-
lished study received Aug 3, 1981 under 432-487; submitted by
Penick Corp., Lyndhurst, NJ; CDL:245845-A; 245846; 245847;
245848)
00128626 Mumma, R.; Vallejo, R.; Pitts, C. (1982) Persistence of Metabolism
of 14C-resmethrin on Greenhouse Grown Tomato Fruit, Lettuce and
Field Grown Wheat. (Unpublished study received May 25, 1983
under 432-487; prepared by Pennsylvania State Univ., Dept. of
Entomology, Pesticide Research Laboratory and Graduate Study
Center, submitted by Penick Corp., Lyndhurst, NJ; CDL:250385-A)
00133890 Green, W.; Wallace, J. (1977) Acute Dermal LD50 Toxicity Study:
SBP-1382 Technical. (Unpublished study received Oct 11, 1979
under 432-487; prepared by Bio-Toxicology Laboratories, Inc.,
submitted by Penick Corp., Lyndhurst, NJ; CDL:241126-N)
00142655 Atkins, E.; Anderson, L.; Kellum, D. et al. (1974) Protecting ho-
ney bees from pesticides. Leaflet 2883. University of Califor-
nia, Division of Agricultural Sciences. 15 p.
00147770 King, C. (1980) SBP-1382 Lifetime Rat Oral: Toxicity and Carcino-
genic Study (FDRL 5271): Study Audit Report. Unpublished study
prepared by Food and Drug Research Laboratories, Inc. 21 p.
00147771 Butler, W. (1980) Chronic Toxicity/Carcinogenicity Programme in
Rats: Test No. SBP-1382 in Diet: (Resmethrin). Unpublished
compilation prepared by Food and Drug Research Laboratories,
Inc. 5 p.
00157961 Gephart, L.; Johnson, W.; Becci, P.; et al. (1980) 180-Day Sub-
chronic Oral Dosing Study with Resmethrin (SBP-1382) in Beagle
Dogs: Laboratory No. 6289. Unpublished study prepared by Food
and Drug Research Laboratories, Inc. 553 p.
00158476 Coombs, D.; Hardy, C.; Clark, G.; et al. (1985) 90-Day Inhalation
Toxicity Study in the Rat: Resmethrin: (SBP - 1382 Technical):
SBP 6/84997- Unpublished study prepared by Huntingdon Research
Centre. 333 p.
00158477 Jackson, G.; Hardy, C. (1984) Acute Inhalation Toxicity in Rats 4-
hour Exposure: SBP-1382: SBP 4A/831042. Unpublished study pre-
pared by Huntingdon Research Centre. 34 p.
•90
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OFFICE OF PESTICIDE PROGRAMS
Citations to be Part of the Data Base Supporting
Registrations Under the Resmethrin Standard
MRID Citation
00158478 Seaber, J. (1984) Delayed Contact Hypersensitivity in the Guinea-
pig with SBP-1382 Insecticide: 84936D/SBP 10/SS. Unpublished
study prepared by Huntingdon Research Centre. 14 p.
00158495 Paul, F. (1985) Letter sent to M. deVries dated August 21, 1985:
Technical resmethrin ...: A lifetime evaluation of the dietary
administration of SBP-1382 (resmethrin) to wistar albino rats:
: Amendment and commentary:: FDRL study No. 5271. Prepared by
Food and Drug Research Laboratories, Inc. 43 p.
00159388 DeVries, M. (1986) Letter sent to A. Castillo dated May 15, 1986:
Resmethrin and/or metabolite determination in cattle resulting
from treatment with SBP-1382, 3% Multipurpose Spray Formula III,
EPA No. 432-635 for premise use of Resmethrin. Prepared by
Penick-Bio UCLAF Corp. 134 p.
00160000 Hudson, R. ; Tucker, R. ; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US Fish and Wildlife
Service: Resource Publication 153. 91 p.
40098001 Mayer, F. ; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter-
pretation and Data Base 410 Chemicals and 66 Species of Fresh-
Water Animals. US Fish & wildlife Service; Resource Publica-
tion (160) : 579 p.
'91
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V. FORMS APPENDICES
'92
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EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICU2UBI SUMMARY SHEET
APPLICANT $ MAME
DATE GUIDANCE DOCUMENT ISSUED
With rwotct to iti* nou>r«mtnt te Mbmn "itnttie" d«t» rmpo»d by t*« FlMA action )(C)(2)(II not*i conttmtd m th« r«(cfinc»d
Gwdinct Oocumtnt. I »m rnpondinf m ttif following monntr:
O 1. I Mill Mbmit d*t« m a timtiy mtnntr te atitfi (tit fflllo«nn| rtquirmriti 11 ffi« tm procidum I wiM u* dt««!t I'om (or *• not
tCKiltfd ml ttii Nttorntien Cwid«iin*i or tti« Protecaii conturwd m tfii Mtponi o* Expert Crouoi to tnt Ctiimejii Group. OECO
CfMimult T«tm| Profnmmt. I tncion tfu protoeoU thtt I wrfl «•:
Attach separate page with a list of the data requirements your
company agrees to satisfy.
O 2. I Mv« tnnrtd wito *n ifrMmtnt with on« or mor* Othtr rtforrinti undtr FIFMA •ciion )(C)(2)(l)(u> te atilty V\t lollOnnng d«U
nquinmtntv Th« ttm. ind «nr rtquirtd protocol!, will b« Mbmmtd to £'* by:
NAME 0* OTH£4 REGISTRANT
Attach list of data requirements
O 3. I tneioM i eomoitttd "Cirtifieition ef Antmpt to Entir Into in Agrttmtnt with Otn«r flifinrinu lor Otvtlopmtnt ol Otu
ruaiet to tn« following
LJ4. I nguat tntt you imind my rtgumtion by dtltting tf>» loliowiog UBI (inn option • not i«m«oit to i:aii:*nu lor n*» proeucaJ:
C S. I r*o.u«t volumwy cineilUnon of thi rtgtitntton pt (hit product. (Thii option is not ivtUibii to ipplonu tor MM producu.)
HIOICTAANT-S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
93
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EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
(To otmlify.
CERTIFICATION Of ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authonted to repreient the following firm(t) who arc aubioct to the require-
ment! of • Notice under FIFRA Section 3(c)(2)(BI contained in a Guidance Document
lo tubmit data concerning the active ingredient:
ACTIVC IMOMCOHMT
NAMf Of ft*M
fFA COMPANY NUMOBCM
(Thii firm or group of firmi it referred to be tow at "my firm".)
2. My firm is willing to develop end tubmit the data « required by that Notice, if neomary. However, my firm would prefer to enter
into en agreement with one or more other registrant* to develop jointly, or to there in the oott of developing, the following required
item* or data:
3. My firm Ka§ offend in writing to enter into each an agreement. Copiei of the offen m machtd. That offer wei irrtvocabk and included an oHir to be
bound by an erbrmnion decnion under FIFRA Section 3(eJ(2)(8)(iii) if final agreement on ell armi could not be rvocned ottierwae. Thd offer •« mao«
to th« following firm(t) on ttif following dettii):
NAMC Of PINM
DATE Of Of ft*
However, none of ity>te firm(t| accepted my offer.
4. My firm requecu that EPA not tutpcnd the regirtrat>on(») of my firm's product(«). if any of the firm* named in paragraph (3) above
have agreed to eubmit the data lifted in peragrach (21 above in accordance with the Notice. I underrtand EPA will promptly inform
me whether my firm mutt mjbmit data to avoid eutoention of iti reginration(s) under FIFRA Section 3(c)(2)(B). (Thii natement
doei not apply to applicant* for new produco.) I give EPA permiuion to dudote din oatement upon requeit.
veto MAMI
8IONATUNC
OAT«
94
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CMB Approval N
2070-0
Expires 11/30/
PRODUCT SPECIFIC DA3A REFCRT
peg Mo
Guidance Document for.
Registration
Subpart C
PtdXX.T
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
incir«;|i «=«pt s.
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Ftivsical state
Odor
Meltina point
Boilina point
Density, bulk-
density, or
specific Gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
Test not
required
for my
product
listed
above
(check
below)
I am complying with
riata reouirements bv
Citing miD
Number or
ETA Accession
Number
'
Submit-
ting
Data
(At-
tach"1)
(For EEA Use Only)
Accession Numbers
i
rU ' ' ' 1
pn ii ii
EFA Form 8580-4
'95
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CMB Approval M
2070-0"
Expires 11/30/:
Reg. Mb..
PRODUCT SPECIFIC DATA REPCRT (COnt'd)
Date
Guidance Document for
Registration
Subpart C
PRODUCT
CHEMISTRY
(ccnt'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
Ttj^roTjOGY
81-1
81-2
81-3
- -81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
r^H^fion
Flannwb/l l^tY
Explorer* t)\ \ \ ty
Storage "Ttaftilitv
Viscosity
Mj'jr'ibiiity
Corrosion
dtTarjcteristics
Dielectric break-
down voltaoe
Acute oral
toxic ity. rat
Acute dermal
toxicitv . rpfifrfi f
Acute inhalation
toxicity. rat
*" Primary "eye
r irritation. r?^t>it
Primary dermal
irritation
Dermal sensitiza-
tion.
81-7 ! Acute Delayed
! nflflNTOtoxicitv. hen
Test not
required
for my
product
listed
above
(check
below)
L
I am complying with
^StS rfTi^J rsp^snts bv
Citing MRID
Number or
EPA Accession
Number
\. — (
Submit-
ting
Data
(At-
tr^C?1?^)
-
h
(For EPA Use Only)
Accession Numbers
Assigned
™
EPA Form 8580-4 (cont'd)
'96
-------
CMB Approval No. 2070-0
Expiration Date 11/30/8
DATA EXEMPTION STATEMENT
EFA Product Registration Nlmber: _. ,. . ._.
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above
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 act:
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, desp:
our lack of intent to sutmit the generic data in question, on the grounds that the prodi
contains the active ingredient solely as the result of the incorporation into the prodi
of another product which contains that active ingredient, which is registered under FT!
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidental Statement of Formula (CSF) for the above-identif:
product is attached to this statement. That formula statement indicates, by company nar
registration number, and product name, the source of the subject active ingredient in
firm's product, or
•Die CSF dated on file with EFA is complete, current and accurate i
contains the information requested on the current CSF Form 8570-4. The register
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 sour
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion
this Statement is no longer true, or if my firm fails to comply with the undertakings ma
in this Statement, my firm's product's registration may be suspended under FIFRA Secti
3(c)(2)(B).
"(5T I further understand~~fcnat ff~my firm is granted a generic data exemption for t
product-, my- firm relies" oir the "efforts of other" persons~~to provide the Agency with't
"required generic~aata;rf~tne~regTstraritTs)~ who~Tiave~ conmotted to generate and sutmit t
required data fail to take appropriate steps to meet requirements or are no longer
compliance with this Notice's data requirements, the Agency will consider that both th
and my firm are not in compliance and will normally initiate proceedings to suspend t
registrations of my firm's product(s) and their product(s), unless my firm commits
sutmit and submits the required data in the specified time frame. I understand that,
such cases, the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature
Dated:
(Typed)
Form 8570-27
•97
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