United States Prevention, Pesticides EPA 738-R-95-041
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
&EPA Reregi strati on
Eligibility Decision (RED)
Tetrachlorvinphos
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
"\, Oon1^ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case
Tetrachlorvinphos. The enclosed Reregistration Eligibility Decision (RED) contains the
Agency's evaluation of the data base of this chemical, its conclusions of the potential human
health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products will be eligible for reregistration. The RED includes the
data and labeling requirements for products for reregistration. It may also include
requirements for additional data (generic) on the active ingredient to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative Jeff
Billingslea at (703) 308-8004. Address any questions on required generic data to the Special
Review and Reregistration Division representative Bill Wooge at (703) 308-8794.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
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concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Tetrachlorvinphos
LIST A
CASE 0321
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
TETRACHLORVINPHOS REREGISTRATION ELIGIBILITY DECISION TEAM . . i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Usage Data 4
D. Use Profile 5
E. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
1. Description of Chemical 5
2. Identification of Active Ingredient 6
3. Manufacturing-Use Products 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic toxicity 9
d. Carcinogenicity 10
e. Developmental Toxicity 10
f. Reproductive Toxicity 11
g. Mutagenicity 11
h. Metabolism 12
i. Dermal Absorption 12
j. Reference Dose and Cancer Potency Factor 13
k. Domestic Animal Safety 13
2. Exposure Assessment 14
a. Dietary Exposure 14
b. Occupational and Residential Exposure 21
3. Risk Assessment 26
a. Dietary Risk 26
b. Occupational and Residential Risk 29
c. Domestic Animal Safety 32
C. Environmental Assessment 32
1. Ecological Toxicity 32
a. Toxicity to Terrestrial Animals 32
b. Toxicity to Aquatic Animals 35
c. Toxicity to Plants 37
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2. Environmental Fate 37
a. Environmental Fate Assessment 37
b. Environmental Chemistry, Fate and Transport 38
3. Ecological Exposure and Risk Characterization 42
a. Exposure and Risk to Nontarget Terrestrial Animals .... 42
b. Exposure and Risk to Nontarget Aquatic Animals 45
c. Exposure and Risk to Nontarget Terrestrial, Semi-Aquatic, and
Aquatic Plants 46
d. Endangered Species 46
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 47
A. Determination of Eligibility 47
1. Eligibility Decision 48
2. Eligible Uses 48
B. Regulatory Position 49
1. Tolerance Reassessment 49
2. Human Health Risks and Eligibility 52
a. Dietary Risk 52
b. Worker Risk 53
c. Homeowner Risk 54
3. Domestic Animal Safety 54
4. Labeling Rationale/Risk Mitigation 54
5. Endangered Species Statement 56
V. ACTIONS REQUIRED BY REGISTRANTS 56
A. Manufacturing-Use Products 56
1. Additional Generic Data Requirements 56
B. End-Use Products 57
1. Additional Product-Specific Data Requirements 57
2. General Labeling Requirements for Products 57
a. All Products 57
b. Products Intended Primarily for Occupational Use 58
c. Occupational Products Used in Recreational Areas 59
d. Products with Feed-Through Uses 59
C. Existing Stocks 59
VI. APPENDICES 61
APPENDIX A. Table of Use Patterns Subject to Reregistration 63
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 87
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Tetrachlorvinphos 93
APPENDIX D. Product Specific Data Call-in 103
Attachment 1. Chemical Status Sheets 115
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Attachment 2. Product Specific Data Call-In Response Forms Plus
Instructions 117
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms and Instructions 119
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 129
Attachment 5. List of All Registrants Sent This Data Call-In Notice
135
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions ... 137
APPENDIX E. List of Available Related Documents 145
TABLES
Table 1 - Estimates of Tetrachlorvinphos Use on Livestock 4
Table 2 - Registered Tetrachlorvinphos Manufacturing-Use Products 6
Table 3 - Acute Toxicity Data 7
Table 4 - Anticipated Residues of Tetrachlorvinphos and Metabolites in Animal
Commodities 20
Table 5 - Exposure Estimates for Tetrachlorvinphos (Mixer/Loader/Applicator) .... 23
Table 6 - Exposure Scenario Descriptions for Tetrachlorvinphos 25
Table 7 - Analysis I: All Commodities with Established and Extended1 Tolerances ... 27
Table 8 - Analysis II: Only Uses Supported for Reregistration 28
Table 9 - Risk Estimates for Occupational/Residential Uses of Tetrachlorvinphos .... 30
Table 10 - Avian Acute Oral Toxicity Findings 32
Table 11 - Avian Subacute Dietary Toxicity Findings 33
Table 12 - Mammalian Acute Oral Toxicity Findings 33
Table 13 - Nontarget Insect Acute Contact Toxicity Findings 34
Table 14 - Nontarget Insect Foliar Residue Toxicity Findings 34
Table 15 - Freshwater Fish Acute Toxicity Findings 35
Table 16 - Freshwater Invertebrate Toxicity Findings 36
Table 17 - Estuarine/Marine Acute Toxicity Findings 37
Table 18 - Summary of Environmental Chemistry , Fate and Transport Data 38
Table 19 - Leaching/Adsorption/Desorption Data for Tetrachlorvinphos in 4 Soils ... 41
Table 20 - Residues on Avian and Mammalian Dietary Food Items in PPM 43
Table 21 - Tolerance Reassessment Summary 51
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TETRACHLORVINPHOS REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Douglas W. Sutherland
Ghulam Ali
Steve Jarboe
Environmental Fate and Effects Division
Sharlene R. Matten
Allen Vaughn
William R. Effland
Health Effects Division
David J. Miller
Patricia McLaughlin
Byron Backus
Kathryn Boyle
Laura E. Morris
Jennifer Wintersteen
Registration Division
John Hebert
George LaRocca
Mark Perry
Special Review and Reregistration Division
Kathy Davis
Bill Wooge
Office of General Counsel:
Jon Fleuchaus
Office of Enforcement and Compliance:
Rick Colbert
Biological Analysis Branch
Economic Analysis Branch
LUIS
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Reregistration Support Chemistry Branch
Toxicology Branch II
Toxicology Branch II
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Science Analysis Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LC
LD
LD10
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MOE
MP
MPI
MRID
N/A
NOEC
Acceptable Daily Intake. A now defunct term for reference dose (RfD) .
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested
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, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g. , mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No effect concentration
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
As required under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended in
1988, the U. S. Environmental Protection Agency has considered the reregistration eligibility for
the pesticide active ingredient tetrachlorvinphos. This eligibility consideration includes a
comprehensive reassessment of the required target data base and use patterns of currently registered
products. The Agency compared its risk assessment to current science and regulatory policies.
Where appropriate, it has imposed changes to the terms for continued registration in order to reduce
risks to human health and the environment.
The Agency has determined that the dermal application to livestock, non-food animal, general
outdoor treatment, and pet uses of tetrachlorvinphos, specified in this document, will not cause
unreasonable risk to humans or the environment and these uses are eligible for reregistration.
However, the Agency cannot make a determination regarding the reregistration eligibility of the feed-
through (oral) livestock use at this time.
The Agency has determined that all uses of tetrachlorvinphos, with the exception of oral feed-
through larvicide treatment to livestock intended for food use, will not cause unreasonable risk to
humans or the environment and these uses are eligible for reregistration. The Agency has reviewed
environmental and toxicological data to reach this decision.
Use Patterns
Tetrachlorvinphos is an organophosphate insecticide. It is currently applied dermally to
livestock to control flies and mites. Tetrachlorvinphos is used as a feed-through (oral) larvicide in
cattle, hogs, goats and horses; in cattle ear tags to control flies; in cattle feedlots; in poultry dust
boxes to control poultry mites; and in poultry houses. Tetrachlorvinphos also is used in pet sleeping
areas and pet flea collars. It is used to control nuisance and public health pests (flies) in and around
refuse sites, recreational areas, and for general outdoor treatment.
Human Health Assessment
Tetrachlorvinphos has been classified as a group C (possible human) carcinogen by the
Carcinogenicity Peer Review Committee of the Agency's Office of Pesticide Programs. It
determined the cancer potency factor (Qx*) of 1.83 x 10~3 (mg/kg/day)"1. Also, a RfD of 0.04 mg/kg
body weight/day was established based on a NOEL of 4.23 mg/kg bwt/day from a chronic rat
feeding study. There were liver histological changes and adrenal changes at 43.2 mg/kg/day (LOEL)
in male rats. An uncertainty factor of 100 was used in setting the RfD.
Because the livestock uses result in human dietary exposure, a tolerance reassessment using
Anticipated Residues (ARs) is included in this document. Confirmatory data describing the residues
in tissues resulting from the dermal livestock treatments are required for the continued registration
of tetrachlorvinphos. These data have been required from the registrant. For feed-through (oral)
larvicide use in livestock, a feed additive tolerance has been established. However, this tolerance
is barred by the Delaney clause of the Federal Food, Drug and Cosmetic Act (FFDCA) which
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provides that a food/feed additive regulation for a livestock feed additive may not be established for
a pesticide which induces cancer in man or animals. This is discussed below and in Section IV of
this document. Data would also be required for the feed-though (oral) larvicide uses; however, this
requirement has been deferred because the feed additive tolerance currently established has been
proposed for revocation under the Delaney clause of the FFDCA. The proposed revocation of the
existing FFDCA section 409 tolerance for tetrachlorvinphos was issued September 21, 1995 in the
60 FR 49141.
Some of the occupational and residential exposures to tetrachlorvinphos are of concern
because of potential cancer risks. Risks to tetrachlorvinphos handlers wearing full protective clothing
range from 5.7 x 10"8 to 1.3 x 10"5. Baseline Personal Protective Equipment (PPE) for occupational
handlers of tetrachlorvinphos end-use products are chemical resistant gloves, long-sleeved shirts and
long pants, socks, and shoes. PPE for homeowner uses (flea collars, aerosol cans for pet sleeping
areas, and dust shakers for pet treatments) are not established in this RED because they are not
warranted due to low exposure and risk. Occupational-use products containing tetrachlorvinphos
which are used on recreational areas are required to carry labeling to restrict re-entry until sprays
have dried, to limit exposure to the wet formulations.
Environmental Assessment
In the environment, tetrachlorvinphos is not persistent but its mobility increases as soil texture
becomes coarse and the organic matter content decreases. The primary route of dissipation is
through biotic degradation. Under alkaline conditions, abiotic processes (e.g., hydrolysis) are
somewhat effective. Parent tetrachlorvinphos is not available from the manure of treated animals and
is therefore not available to the environment from the feed-through (oral) larvicide uses. Based on
current product labeling, it is unlikely that serious detrimental impacts to ground or surface water
will occur from the use of tetrachlorvinphos. Confirmatory data for describing the hydrolysis of
tetrachlorvinphos have been submitted and are in review. The results of this review are not likely
to change the environmental assessment for this pesticide.
Under the use patterns described in this RED document, tetrachlorvinphos poses little acute
or chronic risk to wildlife. Exposure to the environment is expected to be minimal, especially
exposures to aquatic species because of the use patterns. Although the acute levels of concern are
exceeded for fresh water invertebrates and endangered fish and invertebrates, significant risk is
unlikely due to low exposure. Chronic exposures and risks are unlikely because of the use patterns.
Product Reregistration
Before reregistering the tetrachlorvinphos products with eligible uses, the Agency is requiring
that product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any revised
labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister a product. Those products which contain other active ingredients will be eligible for
reregistration only when the other active ingredients are determined to be eligible for reregistration.
vi
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data
submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration 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" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of tetrachlorvinphos. The document consists of six sections. Section I is the
introduction. Section II describes tetrachlorvinphos, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for tetrachlorvinphos.
Section V discusses the reregistration requirements for tetrachlorvinphos. Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: Tetrachlorvinphos
• Chemical Name: (Z)-2-chloro-l(2,4,5-trichlorophenyl) vinyl
dimethyl phosphate
• Chemical Family: Organophosphate
• CAS Registry Number: 22248-79-9 [(Z) - isomer]
22350-76-1 [(E) - isomer]
961-11-5 [mixed isomers]
• OPP Chemical Code: 083701
• Empirical Formula: C10H9C14O4P
• Trade and Other Names: Rabon*, Gardona^
• Basic Manufacturers: Fermenta Animal Health Company
Hartz Mountain Corporation
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of tetrachlorvinphos is
in Appendix A.
For Tetrachlorvinphos:
Type of Pesticide: Organophosphate insecticide
Use Sites:
TERRESTRIAL FEED: Cattle feedlots
INDOOR FOOD: Agricultural/Farm Structures/Buildings and Equipment, Cattle
Feedlots, Beef/Range/Feeder Cattle, Dairy Cattle (Lactating or Unspecified), Dairy
Goats (Lactating or Unspecified), Hog/Pig/Swine (Meat), Livestock, Poultry
(Egg/Meat), Poultry (Meat).
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INDOOR RESIDENTIAL: Cats (Adults/Kittens), Dogs/Canines (Adults/Puppies),
Household/Domestic Dwellings Indoor Premises.
INDOOR NONFOOD: Horses (Show/Race/Special/Ponies), Mink (Fur Animal),
Specialized Animals (such as racing and hunting dogs, show dogs and cats)
TERRESTRIAL NON-FOOD: Recreational Areas, Refuse/Solid Waste Sites
(Outdoor), Wide Area/General Outdoor Treatment (Public Health Use).
Pests: Fleas, ticks, lice, flies (adults and larvae), chiggers, mites, spiders, wasps,
cattle grubs
Formulation Types Registered:
Technical: 98.7% a.i.
Manufacturing use: 97.3% a.i.
Wettable powder: 50% a.i.
Dust: !%,3%a.i.
Granular: 0.18% to 7.76% a.i.
one product 97.3% a.i.
Pelleted/Tableted 0.3% to 1.25% a.i. primarily mineral blocks
for cattle/livestock.
Impregnated material: 3%, 13.7% a.i. pet collars, cattle ear tags.
Liquid, ready-to-use: 1% to 2% a.i. spray on/wipe on/backrub
materials for pets, horses, cattle.
Pressurized liquid: 1% a.i. flea and tick spray for cats.
Emulsifiable concentrate: 23 %, 24 % a.i.
Methods and Rates of Application:
Application methods include: hand application, hand and power sprayers and
dusters, free-choice mineral blocks, livestock feed supplements, poultry dust
boxes, pressurized aerosol cans, pet collars, and cattle ear tags.
Current application rates are largely indeterminate, with directions to spray
thoroughly, to cover animal completely, or to permit free access to backrubs or
mineral blocks.
Use Practice Limitations: None currently.
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C. Usage Data
This section summarizes the best estimates available for the pesticidal uses of
tetrachlorvinphos in the U.S. These estimates are derived from a variety of published and
proprietary sources available to the Agency. These data reflect variability in using data
from various information sources. Table 1, below, summarizes the amounts of
tetrachlorvinphos used by site.
Table 1 - Estimates of Tetrachlorvinphos Use on Livestock
Site
Cattle - Feed Through
Cattle - Dermal
Hogs
Horses
Poultry -Dermal
Other8
Totalh
Pounds a.i.
Per Animal3
0.1725
—
0.0661
0.1808
—
na
Active
Ingredient
Used per
Yearb
(Million Ibs)
2.1
—
0.24
0.12
—
0.44
3.05
Number of
Animals
Treated
c(Million)
12
—
4
1
—
na
12
Total
Number of
Animalsd
(Million)
96
—
111.3
2.1
—
na
211.5
Percentage
of Animals
Treated6
12.7
5-20f
3.18
31
—
na
na
na not available/applicable
a Pounds tetrachlorvinphos (a.i.) per animal was calculated using application rates to
determine the amount of tetrachlorvinphos applied to the animal.
b The total use of tetrachlorvinphos per type of livestock was obtained from an EPA
proprietary database that contains information about tetrachlorvinphos distribution in the
U.S.
c Number animals treated = Ibs active ingredient used/lbs used per animal.
d U.S. Dept. of Commerce, 1992 Census of Agriculture, Volume 1, part 51, October 1994
e Percent livestock treated = number animals treated/total number animals.
f Information was provided by Extension Entomologists from Texas A&M and the
University of Wisconsin, and faculty from Oklahoma State University.
g Information about the use of tetrachlorvinphos in livestock premises is not readily
available. Similarly, information about treated dogs and cats is not available.
h Texas and Oklahoma are assumed to be the major states of tetrachlorvinphos livestock use.
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D. Use Profile
Data required in the October 1988 Registration Standard for tetrachlorvinphos
(Guidance for the Reregistration of Pesticide Products Containing Tetrachlorvinphos)
included studies on product chemistry, ecological effects, environmental fate, and residue
chemistry. These data were required to support the uses listed in the Registration Standard
and registered at that time. Appendix B of this RED document includes all data
requirements identified by the Agency for a reregistration eligibility decision for the
currently registered uses.
E. Regulatory History
Tetrachlorvinphos (commonly referred to by the trade names Rabon and Gardona)
was initially registered for use in the United States in 1966 by the U.S. Department of
Agriculture. The original registrant of technical tetrachlorvinphos was Shell Chemical.
The registration was subsequently transferred to E. I. duPont de Nemours.
In September, 1992, duPont transferred ownership of technical tetrachlorvinphos
data to Hartz Mountain Corporation and Fermenta Animal Health Company. Hartz and
Fermenta each received their own technical grade product registrations in 1992. DuPont
voluntarily canceled its registration in December 1993. A third technical tetrachlorvinphos
product was registered to VMX Pet Products Corporation in 1993. Hartz is responsible
for supplying generic data supporting domestic pet uses and Fermenta is responsible for
supplying generic data supporting livestock uses.
Tetrachlorvinphos was registered for use on various food crops, livestock, pet
animals, and in or around buildings. However, the crop uses were voluntarily canceled
from product registrations in 1987. Currently, the primary uses of tetrachlorvinphos are
the control of manure flies in livestock applied as a feed through in the form of feed
additives; flies and mites in livestock building premises applied as dusts; and ticks and
fleas on domestic pets applied as dusts, sprays, and collars.
In October, 1988, the Agency issued a Registration Standard. In the Standard the
Agency summarized its assessment of the supporting scientific data available at that time
and identified and required the submission of additional data, as mentioned above, to
support continued registration of tetrachlorvinphos products.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Tetrachlorvinphos [(Z)-2-chloro-l-(2,4,5-trichlorophenyl)vinyl dimethyl
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phosphate] is a non-systemic organophosphate insecticide. Its molecular structure
and empirical formula are:
Tetrachlorvinphos (beta isomer)
Empirical Formula: C10H9C14O4P
Molecular Weight: 366.0
CAS Registry No.: 22248-79-9
2. Identification of Active Ingredient
Technical tetrachlorvinphos is a tan to brown crystalline solid with a
melting point of 93-98°C and a bulk density of 50-55 Ib/cu. ft. The solubility of
tetrachlorvinphos in water at 24°C is 15 ppm. Tetrachlorvinphos has limited
solubility in most aromatic hydrocarbons (i.e., 40 ppm in chloroform and
dichloromethane, 20 ppm in acetone, and 8 ppm in xylene at 0°C).
3. Manufacturing-Use Products
There are five tetrachlorvinphos manufacturing-use products (MPs)
currently registered. They are listed below in Table 2.
Table 2 - Registered Tetrachlorvinphos Manufacturing-Use Products
Formulation
98.8% T
98.7% T
98.7% T
97.3% FI
75% FI
EPA Reg. No.
62725-1
2596-131
56493-88
56493-38
56493-19
Registrant
VMX Pet Products Corp.
Hartz Mountain Corp.
Fermenta Animal
Health Company
Date Registered
11/93
9/92
10/92
8/86
8/86
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B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for tetrachlorvinphos is adequate and will
support reregistration eligibility.
a. Acute Toxicity
Acute toxicity values and categories for tetrachlorvinphos are
summarized in Table 3.
Table 3 - Acute Toxicity Data
TEST
Oral LD50-rat
Dermal LD50— rabbit
Inhalation LC50-rat
Eye irritation— rabbit1
Dermal irritation— rabbit1
Dermal sensitization— guinea pig1
RESULTS
1480 mg/kg cf;
465-965 mg/kg ?
>2g/kg
>3.61 mg/L
moderate
slight
sensitizer
CATEGORY
III
III
IV
III
IV
—
Data pertaining to primary eye irritation, dermal irritation, and dermal sensitization are
not required to support the reregistration of the TGAI. These data are presented here for
informational purposes.
From an acute oral toxicity study with rats, the LD50 was estimated
to be 1480 mg/kg for males and between 465 and 965 mg/kg for females
(GDLN 81-1; MRID # 41222504). An acute dermal toxicity study with
rabbits estimated the LD50 to be greater than 2 g/kg (GDLN 81-2; MRID
# 41222505). An acute inhalation toxicity study with rats estimated the
LC50 to be greater than 3.61 mg/L (GDLN 81-3; MRID # 138933).
A primary eye irritation study with rabbits resulted in some iritis
and redness, clearing by the third day, placing tetrachlorvinphos in Toxicity
Category III (GDLN 81-4; MRID # 41222506). In a dermal irritation
study, rabbits exhibited slight irritation, placing tetrachlorvinphos in
-------
toxicity category IV, or low toxicity, for this parameter (GDLN 81-5;
MRID #41222507).
Two dermal sensitization studies with Hartley albino guinea pigs
indicate that tetrachlorvinphos is a moderate sensitizing agent (GDLN 81-6;
MRID # 41377902, 42981001).
Tetrachlorvinphos did not cause delayed neurotoxicity in hens in
two studies. In the first study hens were dosed at 300 mg/kg for 5 days or
1.5 g/kg for 1 day. Results were negative. In the second study,
tetrachlorvinphos was orally administered to hens in 2 oral doses of 2500
mg/kg, given 21 days apart (cumulative total of 5000 mg/kg). This did not
result in delayed neurotoxicity as evidenced by in-life observations and
microscopic examinations (GDLN 81-7; MRID #s 115348, 41905901).
In an acute neurotoxicity study, Sprague Dawley rats were orally
dosed at 0, 65, 325, or 650 mg/kg. Transient neurotoxic effects were
observed in both sexes on day 0 at the two highest doses; these effects were
consistent with cholinesterase inhibition. The LOEL was 325 mg/kg and
the NOEL was 65 mg/kg. Only minor effects remained by day 7, and all
rats were normal by day 14. There was no indication of any permanent
behavioral changes or of any adverse neuropathological effects (GDLN 81-
8; MRID #42912501).
b. Subchronic Toxicity
In a 21-day dermal toxicity study, Crl:CD BR rats were given doses
of 0, 10, 100, or 1000 mg/kg/day tetrachlorvinphos which was applied 6
hours/day, 5 days/week for a total of 15 treatments over the 21 day period.
The NOEL was determined to be 100 mg/kg/day for females and 1000
mg/kg/day for males. The LOEL was 1000 mg/kg/day for females based
on decreased plasma cholinesterase activity. No other systemic effects and
no dermal effects were observed (GDLN 82-3; MRID # 41342001).
Tetrachlorvinphos was given to Sprague Dawley rats in the diet at
doses of 0, 100, 2000, or 5000 ppm (0, 4.23, 43.2, 88.5 mg/kg/day for
males; 0, 5.93, 62.7, 125.3 mg/kg/day for females) for 13 weeks. The
Agency concluded the NOEL to be 100 ppm for both sexes. The LOEL
was 2000 ppm based on reduced plasma and red blood cell (RBC)
cholinesterase activity in both sexes. At the highest dose, these effects
were seen along with reduced brain cholinesterase activity in females. Rats
treated at the two highest doses had reduced body weights and reduced
weight gains, as well as bilateral basophilic tubules of the kidneys in males,
increased fat deposition in the adrenal cortex of females, centrilobular
8
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hepatocellular hypertrophy in females and mid-dose males, and higher
adjusted adrenal weights in females. In both sexes at the two highest doses
there were thyroid follicular cell hypertrophy and higher adjusted liver
weights (GDLN 82-1; MRID # 43371201).
c. Chronic toxicity
In a one-year oral study, tetrachlorvinphos was given to beagle dogs
by capsule at doses of 0, 6.25, 500, or 1000 mg/kg/day. The systemic
NOEL was determined to be 6.25 mg/kg/day. The systemic LOEL was
500 mg/kg/day based on decreased RBC counts, hemoglobin, hematocrit,
and urine specific gravity. There were also increased mean corpuscular
volume, alkaline phosphatase, kidney weights and liver weights. At 1000
mg/kg/day, females showed increased white blood cell (WBC) count and
males exhibited increased prostate weight as well as decreased cholesterol.
The plasma cholinesterase inhibition NOEL in both sexes was 6.25
mg/kg/day and the LOEL was 500 mg/kg/day (GDLN 83-1; MRID #
42679401).
In a two-year oral toxicity study, beagle dogs were given dietary
doses of 0, 5, 25, 125, or 2000 ppm (0, 0.13, 0.63, 3.13, 50 mg/kg/day,
respectively). The Agency concluded the NOEL was 3.13 mg/kg/day.
The LOEL was 50 mg/kg/day, based on decreased plasma cholinesterase
activity and increased relative liver and kidney weights (GDLN 83-1;
MRID #77819).
Tetrachlorvinphos was given to Porton rats at dietary levels of 0, 5,
25, 125, or 2000 ppm (0, 0.25, 1.25, 6.25, and 100 mg/kg/day,
respectively) for two years. The NOEL was determined to be 1.25
mg/kg/day. The LOEL was 6.25 mg/kg/day based on increased liver
weights in females. At the highest dose, effects included lower body
weight, lower food intake, decreased plasma cholinesterase activity in
males, decreased RBC counts and plasma cholinesterase activity in females,
decreased serum total protein, decreased serum urea, decreased male
kidney weights, increased male thyroid weights, and increased female liver
weight (GDLN 83-1; MRID # 112525).
A two-year study with Sprague Dawley rats used doses of 0, 100,
1000, or 2000 ppm tetrachlorvinphos (0, 4.23, 43.2, and 88.5 mg/kg/day
for males; 0, 5.93, 62.7, and 125.3 mg/kg/day for females) in the feed.
The Agency concluded the NOEL for systemic toxicity to be 4.23
mg/kg/day. The LOEL was 43.2 mg/kg/day, based on histological changes
in liver and adrenal glands in both sexes, reduced female weight gains, and
depression of plasma cholinesterase in females. High dose females also had
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elevated cholesterol levels. At termination there were more thyroid C-cell
adenomas for male rats in the high dose than in the controls, but this was
not statistically significant (GDLN 83-1, 83-2; MRID # 42980901).
d. Carcinogenicity
The National Cancer Institute sponsored a carcinogenicity study in
Osborne-Mendel rats using tetrachlorvinphos. The doses were 0, 4250, or
8500 ppm given in the diet for 80 weeks which was followed by
observation for 31 weeks. Increased incidences of adrenal cortical
adenomas and thyroid C-cell adenomas were found in dosed female rats.
High incidences of thyroid C-cell hyperplasia in both sexes further
indicated an effect on the thyroid (MRID # 117443).
In a carcinogenicity study with B6C3F1 mice, animals were fed
diets containing 0, 17.5, 64, 320, 1600, 8000, or 16000 ppm
tetrachlorvinphos for two years. For systemic toxicity, the NOEL was
1600 ppm (240 mg/kg/day) and the LOEL was 8000 ppm (1200
mg/kg/day), based on decreased weight gain. In female mice, there were
statistically significant increased incidences of hepatocellular carcinoma at
8000 and 16000 ppm, of combined adenomas/carcinomas at the three
highest doses, and of adenomas at the highest dose. In male mice, there
were statistically significant increases in combined incidences of
hepatocellular adenomas and carcinomas at the highest dose, and in
adenomas, carcinomas, and combined adenomas/carcinomas of the kidney
at the highest dose (GDLN 83-2; MRID # 126039).
The National Cancer Institute reported another carcinogenicity study
in B6C3F1 mice. Tetrachlorvinphos was given in the feed at doses of 0,
8000, or 16000 ppm for 80 weeks followed by 12 weeks observation.
Increased incidences of hepatocellular carcinomas and granulomatous
lesions of the liver were found in the dosed mice (GDLN 83-2; MRID #
117443).
e. Developmental Toxicity
A developmental toxicity study was conducted with Sprague Dawley
rats. Doses of 0, 75, 150, or 300 mg/kg/day were given to pregnant
females by gavage on days 6-15 of gestation. The Agency determined the
maternal toxicity NOEL to be 75 mg/kg/day. The LOEL was 150
mg/kg/day based on reduced weight gain at both the 150 and 300
mg/kg/day levels. The NOEL for developmental toxicity was 300
mg/kg/day, the highest dose tested (MRID # 42520101).
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Another developmental toxicity study with Sprague Dawley rats
tested doses of 0, 75, 150, or 300 mg/kg/day given by gavage on gestation
days 6-15. The maternal toxicity NOEL was 75 mg/kg/day. The maternal
LOEL was 150 mg/kg/day, based on reductions in weight gain and food
consumption. There were also tremors and chromodacryorrhea at this
dose. No indications of developmental toxicity were seen at the 300
mg/kg/day dose level (MRID # 40152701). These two studies together
fulfill GDLN 83-3.
New Zealand white rabbits were used in a developmental toxicity
study. Doses of 0, 150, 375, or 750 mg/kg/day were given by gavage on
gestation days 6-19. The maternal toxicity NOEL was 375 mg/kg/day.
The maternal LOEL was 750 mg/kg/day based on abortions, red vaginal
fluid, and reduced weight gain. The developmental NOEL was 150
mg/kg/day. The developmental LOEL was 375 mg/kg/day, based on
reduced numbers of viable fetuses and reduced implantations. Animals
treated at the highest dose tested (750 mg/kg/day) also showed an increased
incidence of early resorptions (GDLN 83-3; MRID # 127831).
f. Reproductive Toxicity
In a two-generation reproductive toxicity study, Sprague Dawley
rats were given 0, 100, 500, or 2000 ppm (0, 5, 25, and 100 mg/kg/day,
respectively) tetrachlorvinphos in their diets. The NOEL for systemic
toxicity was 500 ppm. The LOEL was 2000 ppm, based on reduced weight
gains in the Fx generation, increased adrenal gland weights in F0 females,
and reduced weight gains in F0 males. The NOEL for reproductive effects
was 2000 ppm, the highest dose tested (GDLN 83-4; MRID # 42054301).
A three-generation reproductive toxicity study was conducted in rats
with dietary doses of 0, 100, 330, or 1000 ppm (0, 5, 16.5, and 50
mg/kg/day, respectively). The NOEL for the study was 330 ppm. The
LOEL was 1000 ppm based on an increase in liver size in the F3 generation
weanlings. However, no effects were noted microscopically in the livers
or any of the other organs examined. No effect on fertility (number or size
of litters) was noted (GDLN 83-4; MRID # 00077802).
g. Mutagenicity
An Ames test in Salmonella typhimurium exhibited no mutagenic
effect in strains TA98, TA100, TA1535, TA1537, and TA1538, at dose
levels of 66.7, 100, 333, 667, 1000, or 3300 ug/plate with activation, or
at dose levels of 10, 33.3, 66.7, 100, 333, or 667 ug/plate without
activation (MRID # 41222508).
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A test for chromosomal aberration was conducted in Chinese
hamster ovary cells. The Agency concluded that tetrachlorvinphos was
positive for inducing chromosomal aberrations at 59.9, 79.8, and 99.8
ug/mL, but not at 29.9 or 44.9 ug/mL, in the absence of metabolic
activation. However, tetrachlorvinphos was negative for inducing
chromosomal aberrations at 12.5, 25, 37.6, or 75.1 ug/mL in the presence
of rat S9/metabolic activation (MRID # 41312901).
In another study, cultures of rat hepatocytes were dosed with 5, 7.5,
10, 15, 20, 23, 25, 27, 30, 35, or 40 ug/mL of tetrachlorvinphos.
Concentrations of 35 and 40 ug/mL were lethal. Only the cultures exposed
to doses from 10 to 30 ug/mL were analyzed for evidence of unscheduled
DNA synthesis (UDS). The results were negative. (MRID # 42156401).
(These studies fulfill GDLNs 84.)
h. Metabolism
Radiolabelled tetrachlorvinphos was given orally to CD rats as a
single low dose (5 mg/kg), as a single high dose (250 mg/kg), and in a
series of doses (5 mg/kg). It was almost completely metabolized and most
of the label was excreted in urine (46-60%) and feces (38-56%) within 48
hours of dosing. Only minor amounts were found in the tissues. Very
little unmetabolized parent compound was recovered. The metabolic
processes produced a number of different metabolites which were not all
identified. The major metabolite observed in feces was
trichlorophenylethanol with females eliminating more of this metabolite (18
- 34% total administered 14C) than males (13 - 23%) at all three dosing
levels. Trichlorophenylethandiol was also found in feces ranging from 4 -
7 % in males and 3 - 6 % in females. A major metabolite in urine,
trichloromanderic acid, was excreted in males at 19 - 26% but only 10 -
12% in females. At the high dose, females excreted more (25%) desmethyl
tetrachlorvinphos than males (11%). However, there was essentially no
difference for the low dose group with males (8%) and females (7%)
(GDLN 85-1; MRID # 41988401).
i. Dermal Absorption
A study was conducted with male CD rats using doses of 0.01, 0.1,
1, or 5 mg/cm2 radiolabeled tetrachlorvinphos, with some of each dose
group sacrificed at 0.5, 1, 2, 4, or 10 hours. Additionally, there was a
group of animals, sacrificed at 72 hours, in which the skin was washed at
10 hours. The area of the dermal application was washed to recover
unabsorbed tetrachlorvinphos. Then, the skin, urine, feces, and carcass
were analyzed for percent of total tetrachlorvinphos applied. For the group
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sacrificed at 10 hours, 84% of the total applied (0.1 mg/cm2)
tetrachlorvinphos was recovered in the wash, and 9.57% remained in the
skin, urine, feces, and carcass. This absorption value, 9.57%, is used for
assessing human risk following dermal exposure. The percent absorption
increased with the duration of exposure and generally decreased with
increasing dose. The actual quantity of tetrachlorvinphos absorbed
increased with increasing dose (GDLN 85-2; MRID # 42111501).
j. Reference Dose and Cancer Potency Factor
The Reference Dose (RfD) Committee of the Agency's Office of
Pesticide Programs, Health Effects Division (HED) selected a RfD of 0.04
mg/kg body weight/day, based on the NOEL of 4.23 mg/kg bwt/day in the
chronic rat feeding study (MRID # 42980901), discussed above. There
were liver histological changes and adrenal changes observed at 43.2
mg/kg/day (LOEL) in male rats. The Committee applied an uncertainty
factor of 100 to account for inter-species extrapolation and intra-species
variability.
The Cancer Peer Review Committee of HED classified
tetrachlorvinphos as a Group C, possible human carcinogen, based on
statistically significant increases in combined hepatocellular
ademonas/carcinomas (predominantly carcinomas) in the female B6C3F1
mouse, suggestive evidence of thyroid c-cell ademonas and adrenal
pheochromocytomas in the rat (MRID # 126039), and mutagenicity
concerns. The Agency calculated a cancer potency factor (Qx*) of 1.83 x
10"3 (mg/kg/day)"1 using the Weibull 83 time-to-tumor model. A 3/4's
scaling factor was used to convert from mouse to human equivalents.
k. Domestic Animal Safety
Domestic animal safety tests for pets are generally conducted when
cats, dogs, or other domestic animals will be exposed to a given pesticide
through direct application for pest control or to support specific label
claims for products used on pets. One cat and two dog studies were
performed using formulated tetrachlorvinphos products to check for
cholinesterase inhibition.
A 1987 dog study was performed using female beagles that wore
collars impregnated with 14.5% technical tetrachlorvinphos. The dogs
were divided into three groups: control (placebo collar), 1 collar group
(recommended usage), and 2 collar group (2x recommended usage).
Collars were kept on during pregnancy, parturition, and nursing. Collars
identical to the mothers' were placed on the puppies at 4 weeks old. The
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greatest mean measured plasma cholinesterase (ChE) inhibition (about
20-30%, which was statistically significant) occurred 12 days after these
collars were applied. There was no evidence of any significant plasma ChE
inhibition in the mothers or of any red blood cell (RBC) ChE inhibition in
either the mothers or puppies. There were no significant dose-related
differences in weight gains between the three groups of puppies,
particularly when sex ratio differences between the groups were taken into
consideration. (This study was undertaken to satisfy labeling requirements;
MRID # 40436601)
The second dog study was performed using a formulated dip
product (3.1% technical tetrachlorvinphos) applied with a sponge. Each
group was composed of 6 dogs ranging in age from 2 to 12 years. Group
I was sponged with water (control). Group II was sponged with a mixture
of 2 oz. product/1 gallon water (Ix label specified use dilution). Group III
was sponged with a mixture of 8 oz. product/1 gallon water (4x group).
Blood was taken from each animal on days -5, 0 (before treatment), 2, 7,
and 14. There was no evidence of any statistically significant reduction in
RBC and/or plasma ChE activity in any group. (GDLN 86-1; MRID #
41810102).
The cat study was organized in a manner identical to the second dog
study. Groups I, II, and III were the same, with each group composed of
6 cats ranging in age from 3 to 8 years. Blood was taken from each animal
on the same days. The results were consistent in that there was no
evidence of any statistically significant reduction in RBC and/or plasma
ChE activity in any group. (GDLN 86-1; MRID # 41810101)
2. Exposure Assessment
a. Dietary Exposure
Plant Metabolism
While there are established tolerances for tetrachlorvinphos
on certain crops, no currently registered tetrachlorvinphos end-use
product is labeled for use on any plant commodity. Therefore,
plant metabolism data were not required. The Agency has proposed
revocation of the associated tolerances as discussed in Section IV.
Animal Metabolism
The qualitative nature of the residue in ruminants following
oral dosing is adequately understood. In a goat metabolism study
14
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the major metabolites identified were free 1-(2,4,5-
trichlorophenyl)ethanol, conjugated l-(2,4,5-
trichlorophenyl)ethanol, and 2,4,5-trichloroacetophenone. The
proposed metabolic pathway in ruminants following oral
administration involves conversion of tetrachlorvinphos to
trichlorophenylethanol, which is conjugated to glucuronide or
further metabolized to trichloroacetophenone.
Also, the qualitative nature of the residue in ruminants
following dermal application is adequately understood. The major
residues identified were the parent tetrachlorvinphos, free l-(2,4,5-
trichlorophenyl)-ethanol, conjugated l-(2,4,5-
trichlorophenyl)ethanol, and 2,4,5-trichloroacetophenone.
Tetrachlorvinphos was poorly absorbed through the skin,
and most residues adjacent to the application site were not
metabolized. Residues that entered the general circulation were
extensively metabolized in tissues distal to the application site. In
the proposed metabolic pathway in ruminants following dermal
application, tetrachlorvinphos was metabolized to either l-(2,4,5-
trichlorophenyl)ethanol, which is conjugated to glucuronic acid, or
to 2,4,5-trichloroacetophenone, which is converted to 2,4,5-
trichlorobenzoic acid.
The qualitative nature of the residue in poultry following
dermal application is adequately understood. The major residues
identified were the parent tetrachlorvinphos, des-O-methyl
tetrachlorvinphos, free l-(2,4,5-trichlorophenyl)-ethanol, and 1-
(2,4,5-trichlorophenyl)-ethanediol. The metabolite 2,4,5-
trichloroacetophenone was a minor metabolite.
Tetrachlorvinphos was poorly absorbed through the skin of
poultry, and most residues adjacent to the application site were
either not metabolized or were demethylated to des-O-methyl
tetrachlorvinphos. Residues that entered the general circulation
were extensively metabolized in tissues distal to the application site.
The proposed metabolic pathway in poultry following
dermal application is similar to that of ruminants except that
l-(2,4,5-trichlorophenyl)ethanol is not conjugated, but may be
metabolized to the mandelic acid and benzoic acid derivatives via
trichlorophenylethanediol and 2,4,5-trichloroacetophenone.
15
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The metabolism of tetrachlorvinphos in ruminants and
poultry differs. The metabolites des-O-methyl tetrachlorvinphos
and l-(2,4,5-trichlorophenyl)ethanediol are found only in hens, and
the metabolite l-(2,4,5-trichlorophenyl)ethanol is found only in
goats (following both oral and dermal administration). The
difference in metabolic profiles between goats and swine, both
mammals, would be expected to be less significant than the
difference between goats and hens.
From analysis of the above animal metabolism data, the
HED Metabolism Committee has determined that the residues of
concern are tetrachlorvinphos, des-O-methyl tetrachlorvinphos, 1-
(2,4,5-trichlorophenyl)ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and l-(2,4,5-trichlorophenyl)ethanediol.
See Figure A.
Figure A. The Chemical Structures of Tetrachlorvinphos and the Metabolites of Concern.
Des-O-methyl tetrachlorvinphos
l-(2,4,5- Trichlorophenyl)-ethanol
Tetrachlorvinphos (beta
isomer)
l-(2,4,5-Trichlorophenyl)-ethanediol
2,4,5-Trichloroacetophenone
16
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Residue Analytical Methods-Plants and Animals
A gas liquid chromatography (GLC) method for the
determination of tetrachlorvinphos per se in animal commodities is
described in the Pesticide Analytical Method (PAM), Vol. II, as
Method I. Methodology to detect and quantitate the above four
tetrachlorvinphos metabolites of concern does not exist. Therefore,
new or revised methods must be developed for tolerance
enforcement and data collection purposes. The enforcement method
may determine residues of the parent and four metabolites
individually, or may convert all residues, including the parent, to
a common moiety, as long as the parent is also determined
individually. The purpose of the requirement for individual
determination of residues of tetrachlorvinphos is to allow separate
risk assessments for cholinesterase inhibition (involving parent
only) and carcinogenicity (involving parent and four metabolites).
The Agency has required these data from the registrants and has
required them to be submitted by April 30, 1996. These methods
are to be used to recalculate the anticipated residues and the risks
as discussed below.
No tetrachlorvinphos end-use products are currently
registered for use on any plant commodity. Provided existing
tolerances on crops are revoked, methods for analysis of
tetrachlorvinphos residues in plants are not required.
No data pertaining to the behavior of tetrachlorvinphos using
FDA's multiresidue protocols have been submitted. Samples from
the animal metabolism studies must be analyzed by FDA
multiresidue protocols A, B, D, and E to ascertain if the methods
are capable of accurately quantifying all residues of concern,
including the metabolites. The FDA PESTDATA database dated
of August 1993 (PAM Vol. I, Appendix II) indicates that
tetrachlorvinphos (parent) is completely recovered (>80%) using
FDA multiresidue method protocol D (Section 232.4) but is not
recovered using protocol E (Sections 211.1/231.1 and 212.1/232.1,
fatty and nonfatty matrices). The Agency has required these data
from the registrants and has required them to be submitted by April
30, 1996.
Storage Stability
All data requirements pertaining to storage stability have
been evaluated and deemed adequate, except that additional storage
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stability data are required for tetrachlorvinphos and its four
metabolites of concern in animal tissues and milk to support the
required magnitude of the residue in animal studies. The Agency
has required these data from the registrants and has required them
to be submitted by April 30, 1996. Storage stability studies have
been conducted using fortified samples of milk and animal tissues.
Residues of the tetrachlorvinphos per se are stable for 25 days at 0°
C in milk, for 31 days at 0° C in milk fat, for 3 days at room
temperature in muscle, for 4 days at room temperature in kidney,
for 5 days at room temperature in liver, and for 11 days at room
temperature in fat.
Magnitude of the Residue in Plants
Magnitude of the Residue in Processed Food/Feed
Confined/Field Rotational Crops
As stated under Plant Metabolism, no tetrachlorvinphos end-
use products are currently registered for use on any plant
commodity. Therefore, no field residue data, processing data, or
confined/field rotational crop studies were required. The existing
tolerances on crops have been proposed for revocation.
Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
Ruminant, swine, and poultry magnitude of the residue
studies have been reevaluated for reregistration. The Agency
concludes that these studies are inadequate. They failed to reflect
dosing rates representing the maximum expected combined
exposures and do not contain data for all residues of concern.
Therefore, new magnitude of the residue studies reflecting dermal
applications to cattle and poultry are required as confirmatory data.
The Agency has required these data from the registrants and they
are due by April 30, 1996.
Because the Agency cannot make an eligibility determination
for livestock oral feed-through use (refer to Section IV of this
document for more detail), the Agency has deferred the requirement
for new magnitude of the residue studies reflecting oral application
to cattle and swine.
No residue data are required for horses provided that all
applicable labels prohibit treatment of horses destined for slaughter.
The label for the 7.76% G oral larvacide formulation (EPA. Reg.
No. 56493-35) must be amended to prohibit treatment of horses
18
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destined for slaughter, or registrants must include the horse in their
magnitude of residue studies.
Anticipated Residues (ARs)
Due to the inadequate studies for magnitude of the residue
in meat/milk/poultry/eggs, available residue data are insufficient to
assess the established tolerances for residues of tetrachlorvinphos in
the fat of cattle, goats, hogs, horses, sheep, and poultry; in eggs;
and in milk fat (including negligible residues in whole milk). New
magnitude of the residue studies have been required and are due by
April 30, 1996.
The Agency used anticipated residues (ARs) to estimate
human exposures for both chronic and upper bound carcinogenic
dietary risk. The estimates (see Table 4) were developed based on
data from metabolism studies, which at the present time are the best
available residue data. Some of the AR estimates exceed the
current tolerance levels. This results from 1) the use of data from
the nature of the residue studies (metabolism) instead of the use of
data from the magnitude of the residue studies (due to their
inadequacies), and 2) use of a revised tolerance expression which
includes tetrachlorvinphos and the four metabolites of concern.
The Agency's anticipated residue estimates were further
refined using percent uses of livestock treated in the United States.
Two methods were used to estimate the percentages. For dermally-
treated cattle and poultry, percent estimates were obtained from
various sources. These percentages and sources are specified in
Table 1. Five to twenty percent of cattle are treated dermally and
about eleven percent of poultry are treated. For all other livestock,
the percents were calculated using application rates from labels.
These ranged from 3.18 percent for hogs, 12.7 percent for orally-
treated cattle, and 31 percent for horses. Until the oral (feed-
through) tolerance is revoked, it must still be considered in this
evaluation. It should be noted that these estimates are derived on
the basis of certain assumptions and therefore may have a
significant degree of uncertainty. It should be further emphasized
that these estimates were made for the purpose of data refinement
only, since magnitude of the residue data were not available. Once
the required studies have been submitted and evaluated, ARs for
tetrachlorvinphos and its metabolites will be recalculated and the
risk will be re-examined in light of this new information.
19
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Table 4 - Anticipated Residues of Tetrachlorvinphos and Metabolites in Animal Commodities
Commodity
Cattle, meat
[loin muscle, round muscle]
Cattle, fat
Cattle, mbyp
Eggs
Goats, meat
Goats, fat
Goats, mbyp
Hogs, meat
Hogs, fat
Hogs, mbyp
Horses, meat
Horses, fat
Horses, mbyp
Milk
Poultry, meat
[breast muscle, thigh muscle]
Poultry, fat
Poultry, mbyp
Sheep, meat
Sheep, fat
Sheep, mbyp
Tetrachlorvinphos
Plus Regulated
Metabolites From
Oral Nature of the
Residue Studies3
(ppm)
[<0.01, <0.01]b
0.06
0.50
n/a
<0.01
0.06
0.50
<0.01
0.06
0.50
<0.01
0.06
0.50
0.005
nac
nac
nac
<0.01
0.06
0.50
Tetrachlorvinphos
Plus Regulated
Metabolites From
Dermal Nature of
the Residue
Studies3 (ppm)
[1.87, 0.01]
0.10
0.13
0.28
1.87
0.10
0.13
1.87
0.10
0.13
1.87
0.10
0.13
0.02
[0.059, 2.90]
6.94
1.27
1.87
0.10
0.13
Refined
Residues
Using
Percent
Livestock
Treated Data
0.077
0.028
0.090
0.0308
0.387
0.160
0.630
0.012
0.005
0.020
0.000
0.000
0.000
0.005
0.192
0.763
0.140
0.000
0.000
0.000
b
c
These concentrations represent parent plus four metabolites and are to be used for chronic
and carcinogenic dietary risk evaluation.
Apparent analytical limit of quantification (LOQ) 0.01 ppm; l/i LOQ 0.005 ppm.
Not applicable. Not fed to poultry.
20
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Currently, tolerances for tetrachlorvinphos per se exist for
alfalfa; apples; cherries; corn, grain (sweet and pop); cranberries;
peaches; pears; tomatoes; and horse meat, fat and byproducts. The
use of tetrachlorvinphos on these fruit and vegetable commodities
has been voluntarily canceled. The use of tetrachlorvinphos on
horses used for food is prohibited by labeling. Dietary risk was
calculated both with and without these tolerances, based on the
assumption that until these tolerances are revoked, the use of
tetrachlorvinphos could still occur on imported commodities.
b. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are met and (2)
there is potential exposure to handlers (mixers, loaders, applicators) during
use or to persons entering treated sites after application is complete. These
criteria for tetrachlorvinphos and its uses are met. Therefore, the Agency
conducted a limited exposure/risk assessment for handlers of
tetrachlorvinphos using chemical-specific data and other generic data
obtained from the Pesticide Handlers Exposure Database (PHED).
Handler (Mixer/Loader/Applicators) Exposures
In an occupational setting, tetrachlorvinphos is applied by
hand application (e.g., treating cattle with dust formulation), hand
and power sprayers and dusters, free-choice mineral blocks,
granular feed supplements, dust boxes (for poultry), cattle ear tags,
pressurized aerosol cans, and pet collars.
Product label directions permit "free access" (e.g., free-
choice mineral blocks), and include specific maximum rates for
cattle/swine and other farm animal treatments. Products containing
tetrachlorvinphos intended primarily for homeowner use are for
controlling fleas on cats, dogs, and in pet sleeping areas.
Application rates for these spot treatments, when given, are to
"spray thoroughly."
The Agency has determined that there is potential exposure
to mixers, loaders, applicators, or other handlers for use patterns
associated with tetrachlorvinphos. Specifically, the Agency focused
on potential exposures arising from mixing and loading liquids,
wettable powders, and granulars, and from applications of aerosols,
dusters, pellets, power sprayers, low pressure handwands, and
impregnated material (backrubbers).
21
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The Agency required two mixer/loader/applicator (M/L/A)
exposure studies per the Registration Standard for
Tetrachlorvinphos (October 1988). Studies at one indoor site and
one outdoor site were required.
Chemical-specific M/L/A data using the product Rabon® 50
WP were generated by registrants using power sprayers for the
interior of poultry houses (MRID # 42622301). The acceptability
of this study is pending the Agency's verification of the storage
duration of the field samples versus the storage duration of the field
recovery samples. This verification is necessary to validate the
storage stability of tetrachlorvinphos.
Based on the use patterns and potential exposures described
above, EPA identified the major exposure scenarios for
tetrachlorvinphos. These exposure scenarios are presented in Table
5. Table 6 summarizes the personal protective clothing, equipment,
and other assumptions used for each exposure scenario. Protection
factors were applied, when needed, to the exposure data reported in
Table 6 to simulate personal protective equipment such as long-
sleeved shirt and long pants, and the use or absence of gloves. The
Agency relied on the results of the dermal absorption study (MRID
# 42111501, summarized previously) conducted on male CD rats,
which found a 9.57% dermal absorption rate.
22
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Table 5 - Exposure Estimates for Tetrachlorvinphos (Mixer/Loader/Applicator)
Exposure Scenario
(Scenario. #)
Dermal Exposure"
(mg/lb ai)
Inhalation Exposure1"
(mg/lb ai)
Maximum Label
Application Rate0
Daily Maxd
Treated
Daily Dermal
Dosee
(mg/kg/day)
Daily Inhalation
Dosef
(mg/kg/day)
LADD8
(mg/kg/day)
Mixer/Loader Exposure
Liquids (I)
Granules (II)
Wettable Powder (Ilia)
[gloves]
Wettable Powder (Illb)
[no gloves]
0.3
0.03
0.3
1.2
0.0004
0.0024
0.024
0.005
0.027 Ib ai/cow
0.14 Ib ai/cow
40 Ib ai/poultry
house
40 Ib ai/poultry
house
400 cattle
400 cattle
1 poultry house
1 poultry house
0.0044
0.0023
0.016
0.067
.00006
.0019
.014
.0028
1.1 x 104
1 x 10 4
5.3 x 10 4
1.2x 10 3
Applicator Exposure Only
Aerosol Can (IV)h
Dusters (V)h
Pellets (VI)
Power Sprayers (VII)
Impregnating Material (VIII)
109
No Data
No Data
0.6 (gloves)
No Data
3.5
No Data
No Data
0.006
No Data
0.00433 Ib ai/can
No Data
No Data
40 Ib ai/poultry
house
1% solution, 1
gallon per 20
linear feet
1 can
No Data
No Data
1 poultry house
No Data
0.00064
No Data
No Data
0.033
No Data
.00022
No Data
No Data
.0034
No Data
3.1 x 105
No Data
No Data
6.4 x 104
No Data
Mixer/Loader/Applicator
Low Pressure Handwand (IX)
Backpack/Knapsack (X)
103
2.6
0.039
0.03
1.41bai/A
1 .4 Ib ai/A
1 acre
1 acre
0.20
0.0048
.00078
.0006
7.1 x 10 3
1.9 x 10"
Dermal unit exposures are reported as the best fit mean to simulate workers wearing long pants, long-sleeved shirts, and no gloves. The best fit mean is the composite
total dermal exposure based on using the geometric mean for log normal distributed data, arithmetic mean for normal distributed data, and the median for all other
distribution types. The tetrachlorvinphos generated mixer/loader and applicator data are reported as the geometric mean. Protection factors were used to calculate dermal
exposure values because insufficient data are available for PPE in these scenarios. Fifty percent of the total dermal exposure is assumed to be attributed to hand exposure.
Fifty percent protection factor is applied to the dermal (non-hand) exposure for simulating long pants and long-sleeved shirts. NOTE: Worker wore chemical-resistant
gloves in MRID # 42622301.
23
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b Inhalation exposure values are reported as geometric means (log normal distribution). No adjustment has been made to simulate workers wearing dust/mist respirators.
Tetrachlorvinphos labels (56493-29, 56493-34, 56493-13).
d Values represent the maximum area which is assumed to be used in a single day to complete treatments for each exposure scenario of concern.
e The Daily Dermal Dose has been adjusted for dermal absorption based on the data presently available. The Agency assumed ten hours exposure (a typical 8 hour work
day plus time before washing any material from the skin). The value used (9.57%) is a combination of tetrachlorvinphos bound to the skin, that could not be washed off
and is therefore available for absorption, and absorbed tetrachlorvinphos. (MRID 42111501)
Daily Dermal Dose (mg/kg/day) = Exposure (mg/lb ai) X Max. Appl. Rate (Ib ail cycle) X Max. Treated X 0.0957 absorbed
70kg
f Inhalation Daily Dose (mg/kg/day) = Exposure (mg/lb ai) X Max. Appl. Rate (Ib ai/cycle) X Max. Treated
70kg"
(Assumed 100 % absorption via the inhalation pathway.)
8 LADD (mg/kg/day) = [Daily Dermal Dose + Daily Inhalation Dose(mg/kg/day)] X (Work Days Per Yr/365 Days Per Year) X (35 Yrs/70 Yrs)
h May be homeowner and/or occupational use
Exposure Scenarios
I. Liquids - Preparation of livestock, pet, and premise sprays, wipe-ons, and back-rubbers
II. Granular - Preparation of pesticide to livestock feeds
III. Wettable Powder - Preparation of dust for poultry dust boxes
IV. Aerosol Can - Application of pesticide by aerosols to dogs, cats for controlling fleas, ticks
V. Dusters - Application of dusts to livestock - manually and with dust bags, dust boxes for poultry
VI. Pellets - Application of mineral blocks or the additive to animal feeds
VII. Power Sprayers - Application of liquid to poultry houses using pressure sprayers
VIII. Impregnating Materials - Application of soluble liquid to burlap or rope backrubber
XI. Low Pressure Handwand - Application of liquid to cattle feed lots and general outdoor areas (picnic areas, recreational areas)
X. Backpack/Knapsack - Application of liquid to cattle feed lots and general outdoor areas (picnic areas, recreational areas)
24
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Table 6 - Exposure Scenario Descriptions for Tetrachlorvinphos
Exposure Scenario
(Scenario #)
Data
Source
Clothing
Scenario"
Equipment
Standard Assumptions'1
Comments"
Mixer/Loader Exposure
Liquids(I)
Granules (II)
Wettable Powders
(Ilia)
Wettable Powders
(IHb)
PHED
PHED
MRID#
42622301
PHED
Long Pants,
Long-Sleeved
Shirt, No
Gloves
Total
Deposition,
No Gloves
Single Layer
Coveralls,
Gloves
Long Pants,
Long-Sleeved
Shirt, No
Gloves
Open Mixing
Open Mixing
Open Mixing
Open Mixing
Treat cattle every 10 days for 6
months (18 treatments)
Feed to cattle every 10 days for
6 months (18 treatments)
4 Ib ai/100 gal; 1 gal/ 100 birds;
100,000 birds/facility;
treat once every 14 days for 6
months (13 treatments)
4 Ib ai/100 gal; 1 gal/ 100 birds;
100,000 birds/facility;
treat once every 14 days for 6
months (13 treatments)
Acceptable grades;
Dermal =14+ replicates;
Inhalation = 40 replicates;
High confidence in data
All grades;
Dermal = 3 to 14 replicates;
Inhalation =14 replicates;
Low confidence in data
Acceptable grades (pending verification
of storage stability);
Dermal and inhalation = 16 replicates;
High confidence in data (based on
preliminary findings)
All grades;
Dermal = 4 to 33 replicates;
Inhalation = 35 replicates;
Medium to low confidence in data
Applicator Exposure Only
Aerosol Can (IV)
Dusters (V)
Pellets (VI)
Power Sprayers (VII)
Impregnating
Material (VIII)
PHED
No Data
No Data
MRID#
42622301
No Data
Total
Deposition,
Gloves
No Data
No Data
Single Layer
Coveralls,
Gloves
No Data
Aerosol Can
No Data
No Data
Wandtype Sprayers,
Coarse Spray, Single
Nozzle, 100 ft. long
hose
Burlap or Rope
Backrubber
1 can - 1 animal treated once per
week for 6 months (26
treatments)
No Data
No Data
4 Ib ai/100 gal; 1 gal/ 100 birds;
100,000 birds/facility;
treat once every 14 days for 6
months (13 treatments)
No Data
All C grades;
Dermal and Inhalation = 15 replicates;
Medium confidence in data
No Data
No Data
Acceptable grades (pending verification
of storage stability) ;
Dermal and inhalation = 16 replicates;
High confidence in data (based on
preliminary findings)
No Data
Mixer/Loader/Applicator
Low Pressure
Handwand (IX)
Backpack/Knapsack
(X)
PHED
PHED
Long Pants,
Long-Sleeved
Shirt, No
Gloves
Long Pants,
Long-Sleeved
Shirt, Gloves
2 to 3 gallon low
pressure single wand
2 gallon Knapsack
1 acre treated once per week for
6 months (26 treatments)
1 acre treated once per week for
6 months (26 treatments)
All grades;
Inhalation = 95 replicates;
Dermal = 25 to 95 replicates;
Medium confidence in data
Acceptable grades (except for hand
exposure) ;
Inhalation = 9 replicates;
Dermal = 9 replicates;
Medium confidence in data
Clothing scenario represents actual monitored exposure data. The dermal exposure values in Table 5 have been adjusted using
protection factors to simulate long pants, long-sleeved shirt and gloves/no gloves, as noted.
Standard Assumptions based on an 8-hour work day as estimated by OREB. BEAD data were not available.
These grades are based on Quality Assurance/Quality Control data provided as part of the exposure studies. "Acceptable grades"
for dermal and inhalation studies are A and B as defined in Subdivision U Guidelines. All grades that do not meet the guidelines
are listed separately. A replicate refers to data acquired during one complete work cycle. High confidence in data indicates that
there were at least 15 replicates of Grades A and B data. Medium confidence in data indicates that there were at least 15
replicates, but that some of the data did not meet the criteria for Grades A and B data. Low confidence in data indicates that there
were less than 15 replicates of data.
25
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Post-Application Exposure
The Agency believes that there is potential exposure to
persons entering treated sites after application is complete.
As discussed above, tetrachlorvinphos meets the
toxicological criteria (classification as Group C-possible human
carcinogen) for consideration of a risk assessment. However,
because the uses are primarily to animals and in animal areas, the
potential for post-application exposure should be minimal. For
example, for indoor premise-residential use (i.e., aerosol can) the
label states that application to pets and bedding is a spot treatment.
Therefore, post-application exposure data have not been required.
3. Risk Assessment
a. Dietary Risk
An acute dietary risk assessment was not required since an
appropriate toxicological endpoint was not identified.
(1) Chronic Dietary Risk
EPA performed a chronic dietary risk assessment based on
the RfD for tetrachlorvinphos. As discussed previously, the RfD
is 0.04 mg/kg body wt/day based on a chronic rat feeding study
(MRID 42980901).
For this assessment, the Agency performed four analyses
based on different assumptions of residues available in the human
diet. Each assessment calculated the chronic dietary risk for the
overall U.S. population and 22 population subgroups. In Analysis
I (see Table 7), exposure was calculated for all commodities with
established tolerances and commodities where tolerances are to be
established. Assessment la was performed using tolerance level
residues. Tolerances for meat and meat by-product commodities do
not currently exist for cattle, hogs, goats, sheep, and poultry.
These commodities were included in this assessment by extending
the existing fat tolerances to meat and meat-by-products (i.e., the
established tolerance of 0.75 part per million for poultry fat was
used for chicken and turkey). This could result in an
overestimation or underestimation of risk, but due to data
limitations, it was the only method available to the Agency at this
time. A second assessment (Ib) was performed using anticipated
26
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residues for meat, milk, poultry, and eggs (See Table 8). Use of
anticipated residues is considered to be a more accurate estimate of
dietary exposure and therefore a more realistic scenario. However,
for this scenario, anticipated residues were not available for fruit
and vegetable commodities; therefore, it was necessary to use
tolerance level residues for fruits and vegetables in the anticipated
residue calculation. This could result in a possible overestimation
of risk.
In Analysis II, only those commodities supported by the
registrants for reregistration (orally and dermally treated livestock)
were included in the exposure assessments. Alfalfa, apples,
cherries, corn (grain, sweet and pop), cranberries, peaches, pears,
tomatoes, and horse (meat, fat, and byproducts) have been proposed
for revocation, and are not included in this Analysis. Analysis Ha
used tolerance values for residues and Analysis lib used anticipated
residue values from Table 4.
In these four analyses the Agency compared the estimated
dietary exposures to the reference dose (0.04 mg/kg bwt/day) for
a measure of dietary risk. The % RfD is a measure of how much
of the RfD has been taken up by the estimated exposure.
Table 7 - Analysis I: All Commodities with Established and Extended1 Tolerances
Assumed
Residues
Using
Tolerance
Level
Residues (la)
Using
Anticipated
Residues (Ib)
Subgroup
U.S. Population
Non-nursing Infants ( < 1 year)
Nursing Infants ( < 1 year)
Children (1-6 years)
Children (7-12 years)
Exposure
(mg/kg/day)
0.031951
0.153108
0.088606
0.082572
0.049890
%Reference
Dose
80
380
220
210
120
All other subgroups were less than 100% of the RfD
U.S. Population
Non-nursing Infants ( < 1 year)
Nursing Infants ( < 1 year)
Children (1-6 years)
0.023441
0.117466
0.079950
0.061191
59
290
200
150
All other subgroups were less than 100% of the RfD
1 Tolerances for meat and meat by-product commodities do not currently exist for cattle, hogs, goats, sheep, and
poultry. These commodities were included in this assessment by extending the existing fat tolerances to meat and
meat-by-products.
27
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Table 8 - Analysis II: Only Uses Supported for Reregistration
Assumed
Residues
Using
Tolerance
Level
Residues
(Ha)
Using
Anticipated
Residues
(lib)
Subgroup
U.S. Population
Non-nursing Infants ( < 1 year)
Exposure
(mg/kg/day)
0.009036
0.036636
%Reference
Dose
23
92
All other subgroups were less than 57% of the RfD
U.S. Population
Non-nursing Infants ( < 1 year)
Children (1 -6 years)
0.000525
0.000994
0.001100
1
2
3
All other subgroups were less than 3% of the RfD
Overall, chronic dietary risk appears to be minimal when
only uses supported for reregistration are included in the calculation
(Analyses Ha and lib).
(2) Carcinogenic Dietary Risk
The Agency also calculated the upper bound carcinogenic
risk from consumption of food commodities, using anticipated
residues of tetrachlorvinphos in animal products and tolerance levels
in vegetables and fruits, in the following equation:
Upper Bound Cancer Risk = Anticipated Dietary Exposure x Qj*
For the U.S. population, based on a Qx* of 1.83 x 1"6
(mg/kg/day)"1, the upper bound cancer risk was calculated to be 4.3
x 10"5, contributed through all the published tolerances (supported
and unsupported uses) for tetrachlorvinphos. This assumes that
100% of the fruit and vegetable commodities consumed by the U.S.
population are imported and contain tetrachlorvinphos at tolerance
levels.
However, when only commodities of supported food uses
(meat, milk, poultry, and eggs) are considered, the dietary cancer
risk is 1 x 10"6.
28
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b. Occupational and Residential Risk
A short term or intermediate term occupational or residential risk
assessment was not required since an appropriate toxicological endpoint
was not identified.
The Agency's cancer risk estimates for occupational and home uses
of tetrachlorvinphos are presented in Table 9. The Agency lacks data to
evaluate the risks in three worker exposure scenarios: dusters, pellets, and
impregnating material. The Agency believes that the uses of low-pressure
handwands and power sprayers represent worst-case exposure scenarios
(due to the nature of a spraying operation) for the current uses of
tetrachlorvinphos. Since risks to workers under these worst-case scenarios
do not exceed the Agency's level of concern, it is not likely that exposures
resulting from applications of dusts, pellets, or impregnating materials will
exceed the Agency's level of concern. The upper bound estimates of
carcinogenic risk range from 1.3 x 10~5 (low-pressure handwand/
applicator) to 5.7 x 10~8 (aerosol can/applicator).
29
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Table 9 - Risk Estimates for Occupational/Residential Uses of Tetrachlorvinphos
Exposure Scenario
(Scenario #)
Dermal Exposure"
(mg/lb ai)
Inhalation
Exposureb
(mg/lb ai)
Maximum Label
Application
Ratec
Daily Maxd
Treated
Daily
Dermal
Dose6
(mg/kg/day)
Daily
Inhalation
Dose'
(mg/kg/day)
Mixer/Loader/Applicator
LADD8
(mg/kg/day)
RISK11
Mixer/Loader Exposure
Liquids (I)
Granules (II)
Wettable Powder (Ilia)
[gloves]
Wettable Powder (Illb)
[gloves]
0.3
0.03
0.3
1.2
0.0004
0.0024
0.024
0.005
0.027 Ib ai/cow
0.141bai/cow
40 Ib ai/poultry
house
40 Ib ai/poultry
house
400 cattle
400 cattle
1 poultry house
1 poultry house
0.0044
0.0023
0.016
0.067
.00006
.0019
.014
.0028
1.1 x 104
1 x 10 4
5.3 x 10 4
1.2x 10 3
2.0 x 10 7
1.8 x 10 7
9.7 x 107
2.2 x 10 '
Applicator Exposure Only
Aerosol Can (IV)1
Dusters (V)1
Pellets (VI)
Power Sprayers (VII)
[gloves]
Impregnating Material (VIII)
109
No Data
No Data
0.6 (gloves)
No Data
3.5
No Data
No Data
0.006
No Data
0.00433 Ib ai/can
No Data
No Data
40 Ib ai/poultry
house
1% solution, 1
gallon per 20
linear feet
1 can
No Data
No Data
1 poultry house
No Data
0.00064
No Data
No Data
0.033
No Data
.00022
No Data
No Data
.0034
No Data
3.1 x 105
No Data
No Data
6.4 x 104
No Data
5.7 x 10 8
No Data
No Data
1.2x 10 6
No Data
Mixer/Loader/Applicator
Low Pressure Handwand (IX)
Backpack/Knapsack (X)
103
2.6
0.039
0.03
1.41bai/A
1 .4 Ib ai/A
1 acre
1 acre
0.20
0.0048
.00078
.0006
7.1 x 10 3
1.9 x 10"
1.3 x 10 5
3.5 x 10 7
Dermal unit exposures are reported as the best fit mean to simulate workers wearing long pants, long-sleeved shirts, and no gloves. The best fit mean is the composite
total dermal exposure based on using the geometric mean for log normal distributed data, arithmetic mean for normal distributed data, and the median for all other
distribution types. The tetrachlorvinphos generated mixer/loader and applicator data are reported as the geometric mean. Protection factors were used to calculate dermal
exposure values because insufficient data are available for PPE in these scenarios. Fifty percent of the total dermal exposure is assumed to be attributed to hand exposure.
Fifty percent protection factor is applied to the dermal (non-hand) exposure for simulating long pants and long-sleeved shirts. NOTE: Worker wore chemical-resistant
gloves in MRID # 426220301.
Inhalation exposure values are reported as geometric means (log normal distribution). No adjustment has been made to simulate workers wearing dust/mist respirators.
Tetrachlorvinphos labels (56493-29, 56493-34, 56493-13).
30
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d Values represent the maximum area which is assumed to be used in a single day to complete treatments for each exposure scenario of concern.
e The Daily Dermal Dose has been adjusted for dermal absorption based on the data presently available, the Agency assumed ten hours exposure (a typical 8 hour work
day plus time before washing any material from the skin). The value used (9.57%) is a combination of tetrachlorvinphos bound to the skin, that could not be washed off
and is therefore available for absorption, and absorbed tetrachlorvinphos.
(MRID# 42111501)
Daily Dermal Dose (mg/kg/day) = Exposure (mg/lb ai) X Max. Appl. Rate (Ib ai/cycle) X Max. Treated X 0.0957
70kg
f Inhalation Daily Dose (mg/kg/day) = Exposure (mg/lb ai) X Max. Appl. Rate (Ib ai/cycle) X Max. Treated
70kg"
(Assumed 100% absorption via the inhalation pathway)
8 LADD (mg/kg/day) = [Daily Dermal Dose + Daily Inhalation Dose(mg/kg/day)] X (Work Days Per Yr/365 Days Per Year) * (35 Yrs/70 Yrs)
h Risk = LADD (mg/kg/day) X (Q*); where Q* = 1.83 x 10'3 mg/kg/day1.
1 May be homeowner and/or occupational use
31
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c. Domestic Animal Safety
Tetrachlorvinphos may be applied directly to pets for flea control.
Based on the results of studies on cats and dogs, risks to domestic animals
from tetrachlorvinphos products are expected to be minimal.
C. Environmental Assessment
1. Ecological Toxicity
The ecotoxicological data base is adequate to characterize the toxicity of
tetrachlorvinphos to nontarget terrestrial and aquatic organisms when used on the
registered sites.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of tetrachlorvinphos to
birds, the following tests are required using the technical grade
material: one avian single-dose oral (LD50) study on one species
(preferably mallard or bobwhite quail); two subacute dietary studies
(LC50) on one species of waterfowl (preferably the mallard duck)
and one species of upland game bird (preferably bobwhite quail or
ring-necked pheasant).
(a) Avian Acute Toxicity
The Agency relied on studies (MRID # 160000)
using three avian test species. From its review of these
data, the Agency concludes that tetrachlorvinphos is
practically non-toxic to birds.
Table 10 - Avian Acute Oral Toxicity Findings
Species
Mallard duck
Ring-necked pheasant
Chukar1
% Test Material
(TGAI)
Tech.
Tech.
Tech.
LDSO
> 2000 mg/kg
> 2000 mg/kg
> 2000 mg/kg
Conclusions
practically non-toxic
practically non-toxic
practically non-toxic
1 Study is supplemental because chukar is not a recommended species for this test.
32
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These results show that tetrachlorvinphos is
practically non-toxic to birds. The guideline requirement
for the avian acute oral LD50 study is fulfilled. (MRID #
160000)
(b) Avian Subacute Dietary Toxicity
Table 11 - Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
% Test Material
96
96
LCSO
>5000 ppm
>5000 ppm
Conclusions
practically nontoxic
practically nontoxic
On a subacute dietary basis, tetrachlorvinphos is
practically nontoxic to birds. Two studies, one on the
mallard duck and one on the bobwhite quail produced LC50s
> 5000 ppm (MRID # 22923).
(2) Birds, Chronic
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive toxicity. These conditions
do not apply to the current registered uses of tetrachlorvinphos,
therefore, avian reproduction studies are not required at this time.
(3) Mammals
Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent environmental
fate characteristics. Data to describe toxicity to wild mammals
were not required for tetrachlorvinphos.
Table 12 - Mammalian Acute Oral Toxicity Findings
Species
Rat
LDso(mg/kg)
1480
Conclusion
slightly toxic
33
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The available mammalian data indicate that
tetrachlorvinphos is slightly toxic to small mammals on an acute
basis.
As stated in our discussion of the toxicological database
above, on a chronic basis, a three-generation reproduction study
with rats produced a reproductive NOEL of 330 ppm and an LOEL
of 1000 ppm. (MRID # 77802)
(4)
Insects
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. The minimum data
required to establish the acute toxicity to honey bees is an acute
contact LD50 study with the technical material. Through the general
outdoor treatments, some exposure to honey bees is expected,
therefore, these data were required for tetrachlorvinphos.
Table 13 - Nontarget Insect Acute Contact Toxicity Findings
Species
Apis mellifera
% Test Material
Technical
LDso
1.37 jig/bee
Conclusion
highly toxic
There is sufficient information to characterize
tetrachlorvinphos as highly toxic to bees. The guideline
requirement is fulfilled (MRID # 36935).
When data from the acute study provide an LD50 < 11
/xg/bee, a foliar residue toxicity study is required.
Table 14 - Nontarget Insect Foliar Residue Toxicity Findings
Species
Apis mellifera
% Test Material
21bEC
Conclusion
At 1 Ib a.i./A, 3 hour old residues caused 4% mortality
Results from this study indicate that tetrachlorvinphos foliar
residues remained toxic to honey bees for less than 3 hours. The
honey bee foliar residue testing requirement is fulfilled (MRID #
5000837).
34
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b. Toxicity to Aquatic Animals
(1) Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater
fish, the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies. One study
should use a coldwater species (preferably the rainbow trout), and
the other should use a warmwater species (preferably the bluegill
sunfish).
Table 15 - Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Bluegill sunfish
Channel catfish1
% Test Material (TGAI)
75 (formulated product)
94
94
LCSO
0.43 ppm
0.53 ppm
>0.5 ppm
Conclusions
highly toxic
highly toxic
highly toxic
1 Study is supplemental, because an LC50 was not determined.
The results of the two 96-hour acute toxicity studies indicate
that tetrachlorvinphos is highly toxic to both cold- and warmwater
fish. The guideline requirement for acute toxicity testing of the
technical ingredient on freshwater fish (warmwater) is fulfilled
(MRID # 40098001). However, the requirement for testing the
technical pesticide on coldwater fish has not been satisfied. Because
of mitigating factors (data are available for other fish species, end
use product data are available for rainbow trout, and the likelihood
that exposure is minimal), the Agency is not requiring this study.
Formulated product testing on fish has been required
because the LC50 values of the technical pesticide is less than the
EEC in the aquatic environment. The results of the 96-hour acute
toxicity study with rainbow trout as the test species and with a 75 %
formulated product indicate that tetrachlorvinphos is highly toxic to
freshwater fish (MRID # 40098001).
(2) Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a
pesticide is a freshwater aquatic invertebrate toxicity test, preferably
35
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using first instar Daphnia magna or early instar amphipods,
stoneflies, mayflies, or midges.
Table 16 - Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% Test Material (TGAI)
99
LCSO
1.9ppb
Conclusions
very highly toxic
There is sufficient information to characterize
tetrachlorvinphos as very highly toxic to aquatic invertebrates. The
guideline requirement is fulfilled (MRID #41257101).
An aquatic invertebrate life cycle test is required when a
product is applied directly to water or is expected to be transported
to aquatic sites and 1) exposure of aquatic organisms will be
continual or recurrent; or 2) the lowest EC50 is 1 mg/L or less; or
3) the EEC in water is equal to or greater than 0.01 of any EC50; or
4) if the EEC is less than any EC50 and the product has reproductive
effects on, or cumulative effects in aquatic organisms, or has a half-
life in water greater than 4 days.
For tetrachlorvinphos, the laboratory EC50 value is less than
1 mg/L. No acceptable aquatic invertebrate life cycle data are
available for tetrachlorvinphos. The requirement was previously
reserved pending review of the manure dissipation study. Because
no parent compound was found in manure following the feed-
through study, data from an aquatic invertebrate life cycle study are
not required.
(3) Estuarine/Marine Animal Toxicity
Acute toxicity testing with marine and estuarine organisms
is required when an end-use product is intended for direct
application to the marine and estuarine environment or is expected
to reach this environment in significant concentrations. The uses of
tetrachlorvinphos are unlikely to result in exposure to the marine
and estuarine environment.
The requirements under this category include a 96-hour LC50
for an estuarine fish, a 96-hour LC50 for shrimp, and either a 48-
hour embryo-larvae study or a 96-hour shell deposition study with
oysters.
36
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Table 17 - Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster embryo larvae
Pink Shrimp
Spot
% Test Material
(TGAI)
94
94
94
LCSO
> 1000 ppb
280 ppb
> 1000 ppb
Conclusions
moderately toxic
very highly toxic
moderately toxic
2.
There is sufficient information to characterize
tetrachlorvinphos as highly toxic to marine and estuarine shrimp.
No studies were required to fulfill this guideline. However, the
submitted studies were reviewed and are considered supplemental.
(MRID # 40228401)
c. Toxicity to Plants
Terrestrial and aquatic plant testing is not required for
tetrachlorvinphos. Non-target plant testing is only required for insecticides
if there are reported incidents of adverse effects to non-target plants, which
there are not for tetrachlorvinphos.
Environmental Fate
Environmental fate data requirements are fulfilled except for hydrolysis
(161-1). The submitted hydrolysis study is partially acceptable; information on the
fate of tetrachlorvinphos is acceptable for acidic (pH 5) and neutral (pH 7)
conditions. Clarification has been required from the registrant to characterize the
[14C] residues in the pH 9 solutions at the 21- and 30-day sampling intervals. The
clarification will be used to assess the fate of the primary degradates of
tetrachlorvinphos which form during alkaline hydrolysis. The Agency believes the
clarification regarding the alkaline (pH 9) hydrolysis study will supply
confirmatory data and the attached environmental fate assessment will not change
appreciably with the confirmatory data. Sufficient data for a comprehensive
qualitative environmental fate assessment of tetrachlorvinphos are available and are
summarized below.
a.
Environmental Fate Assessment
Based on the current information in the environmental fate data base
required for reregistration of tetrachlorvinphos, the Agency considers
tetrachlorvinphos to be non-persistent and has a mobility that varies from
37
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mobile in coarse-textured, low organic matter soils to relatively immobile
in fine-textured soils with 2-3% organic matter. The principal route of
dissipation for tetrachlorvinphos is through biotic processes such as
microbially-mediated metabolism (aerobic soil metabolism half-life of 4.4
days). Abiotic processes such as hydrolysis are more effective at degrading
tetrachlorvinphos under alkaline (t1/2@pH9 = 10 days) conditions; however,
hydrolytic degradation is relatively ineffective at neutral to acid pH
conditions (t1/2 @PH 7 = 30 days; ^2 @pH 5 = 57 days). Based on the
submitted batch equilibrium studies, the mobility of tetrachlorvinphos
varies from mobile (Kds ranged from 0.6-4.0 mL/g) in coarse-textured soils
(e.g., sands, sandy loams with < 1 % organic matter) to relatively immobile
(Kds ranged from 8.2-13.7 mL/g) in fine-textured soils (e.g., loams, silty
clays with 2-3% organic matter). Under simulated field conditions, parent
tetrachlorvinphos was not detected in manure which had been collected
from a beef cow treated with tetrachlorvinphos as a feed additive. Based
on the environmental fate assessment for tetrachlorvinphos, the use of
tetrachlorvinphos will not, according to current product labeling, create
serious detrimental impacts to either ground water or surface water
environmental media.
b. Environmental Chemistry, Fate and Transport
Table 18 - Summary of Environmental Chemistry , Fate and Transport Data
GUIDELINE #
161-1
162-1
163-1
164-A-SS
DATA REQUIREMENT
Hydrolysis
Aerobic soil metabolism
Mobility
Dissipation of Residue in
Livestock Manure
SUMMARY
Hydrolysis is more rapid under alkaline conditions (partially
acceptable study).
ti/2epH9: 10 days < t1/2@pH7: 30 days < t1/2(8pH5: 57 days
Nonpersistent; t1/2 = 4.4 days (Blackoar loam); acceptable study
1/2 < 8 days (medium loam) ; supplemental study
Varies from mobile (Kds: 0.6-4.0 mL/g) in coarse- textured soils
(e.g., sands, sandy loams with < 1% organic matter) to relatively
immobile (Kds: 8.2-13.7 mL/g) in fine- textured soils (e.g., loams,
silty clays with 2-3 % organic matter)
Tetrachlorvinphos administered to a beef cow as a feed additive
was not detected in manure which had weathered under simulated
field conditions.
(1) Hydrolysis (161-1)
Hydrolysis data at pH 5 and 7 indicate that hydrolysis is
more rapid under alkaline conditions. Tetrachlorvinphos was
38
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shown to degrade via hydrolysis with the most rapid hydrolytic
degradation occurring under alkaline conditions (t1/2 ~
(approximately) 10 days at pH 9; t1/2 ~ 30 days at pH 7; \/2 ~ 57
days atpH 5).
The study by Blumhorst (1991) was found partially
acceptable for fulfilling the hydrolysis data requirement. The
portions of this study conducted at pH 5 and 7 are acceptable.
Tetrachlorvinphos degraded with a half-life of 10.3 days in a sterile
pH 9, 0.01 M aqueous buffer solution that was incubated in the
dark at 25°C; the hydrolytic half-lives were 29.8 and 57.3 days for
pH 7 and 5 solutions, respectively, that were incubated under
similar conditions. Two major degradates, 1-oxo-1-[2,4,5-
trichlorophenyl]-2-hydroxyethane and l-(2,4,5-trichlorophenyl)
vinyl dimethyl phosphate (TVDP) (or its cyclic isomer, CTVDP),
were identified in the treated buffer solutions. The TVDP/CTVDP
isomers were identified only in the pH 9 test solutions with
maximum concentrations of «28% of the applied radioactivity at 21
days which decreased to ~ 15% of the applied at 30 days. During
the study, material balances ranged from 97.6-101.8% of the
applied. (MRID # 41929101)
In order for the pH 9 test solution data to contribute towards
the fulfillment of the hydrolysis data requirement, the registrant
must clarify the discrepancies between the UV and radioactivity
detection and must conclusively identify [14C] residues present in
the methylene chloride extracts of the 21- and 30-day pH 9
solutions. The clarification will be used to assess the fate of the
primary degradates of tetrachlorvinphos which form during alkaline
hydrolysis. The Agency believes that clarification regarding the
alkaline (pH 9) hydrolysis study will simply supply confirmatory
data. The registrant has submitted additional hydrolysis data
(MRID # 43663501) to upgrade the existing study, and these data
are in review. The overall environmental fate assessment will not
change appreciably with the addition of this confirmatory data.
(2) Aerobic Soil Metabolism (162-1)
Tetrachlorvinphos degraded rapidly with a calculated half-
life of 4.4 days, in Blackoar loam soil (MO; fine-silty, mixed,
mesic Fluvaquentic Haplaquolls) that was incubated in the dark at
22 + 2 °C and 75% of 0.33 bar moisture capacity. Five degradates
were identified. For carbon dioxide, approximately 9% of the
applied remained at 302 days post-application. For 2-chloro-l-
39
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(2,4,5-trichlorophenyl)ethanol, a maximum of 14.1% of the applied
remained at 7 days post-treatment, decreasing to approximately
0.40% by 60 days post-treatment. For l-(2,4,5-
trichlorophenyl)ethanol, a maximum of 28.3% of the applied
remained at 4 days post-treatment, decreasing to approximately 1 %
of the applied by 302 days post-treatment. For 2,4,5-
trichloroacetophenone, a maximum of 50.7% of the applied
remained at 60 days post-treatment, decreasing to 19.1% by 302
days post-treatment. For 2,4,5-trichlorobenzoic acid and one or
more dichlorobenzoic acid isomers, a maximum of 17.4% of the
applied remained at 99 days post-treatment, and decreased to 14.4%
of the applied at 302 days post-treatment. In the sterile soil system,
tetrachlorvinphos monomethyl ester was the only degradate detected
(concentrations remaining ranged from approximately 0.6% of the
applied at 3 days post-treatment to a maximum of approximately
4% of the applied at day 31) (MRID #42082401). This study may
be upgraded to acceptable by providing information on the aerobic
metabolism of phenyl-labeled tetrachlorvinphos in a Blackoar loam
soil; however, no further information is required. The information
provided in this study and in the study described below provide
adequate aerobic soil metabolism data.
A study by Beynon and Wright (1968) provides
supplemental data on the aerobic soil metabolism of
tetrachlorvinphos in a "medium" loam soil. In this study, vinyl
carbon-labeled [14C] tetrachlorvinphos (purity unspecified), at 13.4
ppm, degraded with a half-life of < 8 days. Two major degradates,
each accounting for <28% of the applied in the medium loam soil,
were identified as l-(2,4,5-trichlorophenyl)-2-chloroethan-l-ol
(maximum of 28% of the applied at day 16, decreasing to 18% of
the applied at 30 days) and l-(2,4,5-trichlorophenyl)ethan-l-ol
(maximum of -25% of the applied at day 16 and 30). Additional
minor degradates detected were l-chloroacetyl-2,4,5-
trichlorobenzene (<5% at all sampling times), 2,4,5-
trichloroacetophenone (maximum of 9% at day 30), and l-(2,4,5-
trichlorophenyl)ethane-diol (< 1 % at all sampling times). The
distribution of the unextractable radioactivity ranged from 23 % of
the applied at day 8 to a maximum of 33 % of the applied at day 30.
Data on the clay loam, sandy loam, and peat soil textures were not
acceptable because only one sampling period (day 30) was
conducted. New data for the three soils (clay loam, sandy loam,
peat) are not needed, however, because the other two soils tested
(Blackoar loam and "medium" loam) showed tetrachlorvinphos is
not persistent (half-lives of 4-8 days). (MRID # 77821)
40
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(3) Leaching/Adsorption/Desorption (163-1)
Results of the batch equilibrium tests indicates
tetrachlorvinphos is mobile (Kd <1.0) in sandy loam, slightly
mobile (Kd <5.0) in sand, and relatively immobile (£ >5.0) in
loam and silty clay soils. Reported Freundlich Kads_des values were
0.60-0.69 for sandy loam (pH = 8.0; Kom = 1038-1195), 4.04-5.09
for sand (pH = 5.6; Kom = 871-1097), 8.18-9.04 for loam (pH =
6.1; Kom = 522-577), and 13.7-13.8 for the silty clay soil (pH =
5.6; Kom = 1074-1081). Data collected during the batch
equilibrium tests suggests that sorption of tetrachlorvinphos
probably results from binding to soil organic matter and/or clay.
Table 19 - Leaching/Adsorption/Desorption Data for Tetrachlorvinphos in 4 Soils
Soil
Texture
sand
sandy loam
loam
silty clay
Clay
(%)
4
7
14
40
Organic
Matter (%)
0.8
0.1
2.7
2.2
CEC
(meq/lOOg)
2.0
8.1
10.1
21.1
Kads
(mL/g)
4.04
0.60
8.18
13.7
Kdes
(mL/g)
5.09
0.69
9.04
13.8
T^
ads,om
(mL/g)
871
1038
522
1074
T^
des,om
(mL/g)
1097
1195
577
1081
This study (Blumhorst, 1990) is acceptable and can be used
to fulfill the Mobility by Leaching/Adsorption/Desorption data
requirement. However, the Kds determined in this study may
overestimate the mobility of tetrachlorvinphos because of
uncertainty regarding the soil/testing solution equilibration time.
During preliminary testing, the degradation of tetrachlorvinphos
after 24 and 48 hours necessitated establishing a study equilibration
time of 4 hours. However, it could not be determined if
tetrachlorvinphos had established equilibrium between the soil and
water phases at the time of sampling. (MRID # 41681301)
(4) Dissipation of Residues in Livestock Manure (164-A-SS)
The standard guideline data requirement Terrestrial Field
Dissipation was replaced with the special study Dissipation of
Residues in Livestock Manure because tetrachlorvinphos is used
primarily as a feed additive for controlling flies associated with
livestock, leaving tetrachlorvinphos residues in the feces. The
manure dissipation study (Krautter, 1993) was required to assess the
41
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dissipation of tetrachlorvinphos under simulated field conditions.
The study measured tetrachlorvinphos and its residues present in
manure from a treated beef cow. The manure from treated cows
may be applied to agricultural fields prior to planting food crops.
Parent tetrachlorvinphos was not isolated in the compost
samples at any sampling interval. Total residues of
tetrachlorvinphos [beta isomer, (Z)-2-chloro-l-(2,4,5-
trichlorophenyl)vinyl dimethyl phosphate] did not decline during 6
months of storage from composted manure collected throughout
treatment from a cow treated orally at 70.4 mg a.i./100 pounds/day
for 14 days. There were several degradates identified in the
compost samples. Sixty-nine percent of the radioactivity at day 0
was found in l-(2,4,5-trichlorophenyl)-ethanol and approximately
40% of the recovered radioactivity at 3 and 6 months sampling
times. Seven percent of the radioactivity was recovered as 1-
(2,4,5-trichlorophenyl)-2-chloroethanol at day 0, but not detected
at 3 and 6 months sampling times. Approximately 10% of the
recovered radioactivity was detected as 2,4,5-trichlorobenzoic acid
at the 6 month sampling time. Eight additional degradates were
isolated from the manure at 0.3 to 5.3 ppm (maximum
concentrations of 10% of the recovered radioactivity) but were not
identified. The unidentified compounds were not characterized
following attempted extraction with strong acid (6N HC1) or strong
base (6N NaOH) extractants. Unextracted radioactivity was 9.2%
and 23 % of the recovered radioactivity at the Day 0 and 6 month
sampling times, respectively. (MRID # 42848501)
3. Ecological Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Terrestrial Animals
Given the use patterns of tetrachlorvinphos, exposure of nontarget
terrestrial organisms to tetrachlorvinphos will be minimal. The uses most
likely to result in exposure would be the general outdoor and agricultural
premise treatments. The maximum application rate for such uses is 1 Ib
a.i./A.
The Agency's acute toxicity level of concern for an avian or
mammalian species is a risk quotient value greater than or equal to 0.5.
The risk quotient (RQ) is calculated from the preliminary estimated
environmental concentration (EEC) divided by the lowest LC50 value for
birds and mammals. There is a potential for acute risk if the risk quotient
is greater than or equal to 0.5.
42
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The maximum concentration of residues of tetrachlorvinphos which
may be expected to occur on selected avian or mammalian dietary food
items following a single foliar application at two application rates is
provided in the table below:
Table 20 - Residues on Avian and Mammalian Dietary Food Items in PPM
Use Sites
Range Grasses (short)
Fruit/Vegetable Leaves
Forage and Insects
Seeds
Fruits
Application rates (Ib a.i./A)
0.75
180
95
44
9
6
1.0
240
125
58
12
7
* Residue data are from the Kenaga nomograph. Most current reference is Fletcher et. al., 1994.
(1) Birds
Avian acute oral or subacute dietary risks are not expected
for tetrachlorvinphos. Residues found on dietary food items
following a single application of tetrachlorvinphos may be
compared to LC50 values to predict hazard.
Tetrachlorvinphos is practically nontoxic to birds, as
indicated by tests conducted on the representative test species,
mallard duck, ring-necked pheasant, and chukar. Acute LD50 and
LC50 values are >2000 mg/kg and >5000 ppm, respectively.
The highest expected environmental concentration is 240
ppm on short range grasses for the maximum application of 1.0 Ib
of active ingredient per acre (see Table 20).
EEC = 240 ppm = .05
LC50 5000 ppm
This suggests that tetrachlorvinphos is unlikely to be of risk to
birds, from acute oral or subacute dietary exposure.
43
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Because exposure to birds is not expected to be repeated or
continuous, chronic effects are not anticipated.
Nonendangered or endangered omnivorous bird species, and
bird species that eat only seeds, only insects, or only fruit are also
unlikely to be affected (risk quotients less than 0.1).
(2) Mammals
Acute toxicological data show tetrachlorvinphos to be
slightly toxic to mammals on an acute basis (rat LD50 = 1480
mg/kg) (MRID # 41222504). In the absence of mammalian LC50
data, hazard assessment will be based on the LD50 value, as follows.
Using the relationship (pesticide residue in the diet (ppm) *
food consumption (kg)/body weight (kg) = mg pesticide/kg/day)
(Lehman, 1959), one can determine the amount of daily dietary
residue needed to obtain the LD50 of an organism. For example:
i The food consumption and body weight for a young rat are
typically 0.01 kg and 0.1 kg, respectively. Therefore, a
young rat consumes food at a rate of 10 % of its body
weight on a daily basis.
ii The LD50 for tetrachlorvinphos to rats is 1480 mg/kg. This
represents an LC50 of 148 mg/animal (1480 mg/kg * 0.1 kg
= 148 mg/animal).
iii To obtain an LD50 of 148 mg/animal a dietary residue of
14,800 ppm is required:
ppm * food consumption (kg)/body weight (kg) =
mg/kg/day
ppm * 0.01 kg/0.1 kg = 1480 mg/kg/day
ppm = 14,800
The high risk LOG for terrestrial organisms is 0.5. When
the acute risk quotient (RQ) (RQ = EEC/LC50) reaches, or exceeds,
this value (0.5) high risk is presumed. For tetrachlorvinphos, a
terrestrial EEC of 7400 ppm is required to obtain 0.5 (RQ = 7400
ppm/14,800 ppm = 0.5).
44
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As can be seen in the residue table above (Table 20),
residues at this level will not be found, even following application
at the highest rate. Thus, significant acute hazard to mammals is
not expected. (Reference: Lehman, A. J. 1959. In: Appraisal of
the Safety of Chemicals in Foods, Drugs, and Cosmetics.
Association of Food and Drug Officials of the United States.
Austin, Texas.)
(3) Insects
Significant risk to non-target insect species is not expected
from use of tetrachlorvinphos. For nontarget insects, the honeybee
is the representative test species; with an acute contact LD50 value
of 1.37 /xg/bee, tetrachlorvinphos is highly toxic to honeybees.
However, registered uses of this pesticide are unlikely to result in
significant exposure to bees. Hence, an insignificant risk is
expected to nontarget insects as a result of exposure to
tetrachlorvinphos.
b. Exposure and Risk to Nontarget Aquatic Animals
Given the use information available for tetrachlorvinphos, exposure
of nontarget aquatic organisms to tetrachlorvinphos will be minimal. The
uses most likely to result in exposure would be the general outdoor and
agricultural premise treatments. Aquatic organisms may be exposed to
tetrachlorvinphos via runoff from agricultural premises (e.g., feedlots).
The maximum rate for such uses would be 1 Ib a.i./A.
Minimal acute risk to aquatic animals is expected. Moreover,
chronic risk to aquatic animals is not anticipated because of the relatively
low potential for chronic exposure.
The freshwater EEC following application at 1 Ib a.i./A would be
30.5 ppb.
For unincorporated ground application
1 Ib X 0.05 (5% runoff) X 10 A (from 10 acre drainage basin) = 0.5 Ib
*EEC of 1 Ib a.i. direct application to 1 A surface water body 6-feet deep
= 61 ppm
Therefore, EEC = 61 ppb X 0.5 Ib total runoff = 30.5 ppb.
45
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To estimate acute risk to aquatic animals, the Agency compared the
risk quotient (EEC of 30.5 ppb/LC50) to the level of concern value (greater
than or equal to 0.5). The ecotoxicity values used in this risk assessment
are: rainbow trout LC50 = 0.43 ppm and Daphnia magna EC 50 = 1.9 ppb.
The freshwater fish LOG is be exceeded with a risk quotient of 0.07. The
aquatic invertebrate LOG is also exceeded with a risk quotient of 16.05,
indicating a potential for acute risk to freshwater invertebrates. However,
these risks are considered to be minimal because tetrachlorvinphos is used
primarily in applications which will not result in exposure to the aquatic
environment. The only exposure of concern for tetrachlorvinphos is
possible runoff from the manure of treated farm animals. However, the
manure dissipation study (see Environmental Fate section) indicates that no
tetrachlorvinphos was found in weathered manure following feed-through
treatment. Therefore, no acute risk to aquatic organisms is anticipated.
Chronic risk to aquatic organisms is not expected because chronic exposure
is not expected.
c. Exposure and Risk to Nontarget Terrestrial, Semi-Aquatic, and
Aquatic Plants
Unless there are known reports of phytotoxicity resulting from the
use of a specific insecticide, terrestrial and aquatic plant testing are not
required. There are no known incidents of adverse effects to plants
resulting from tetrachlorvinphos use that have been reported to the Agency.
Therefore, the Agency assumes the potential risk to plants is insignificant.
d. Endangered Species
For endangered avian and mammalian species the level of concern
is a risk quotient value greater than or equal to 0.1. For endangered
aquatic vertebrate and invertebrate species, the LOG is a risk quotient value
greater than or equal to 0.05. And for endangered plant species, the LOG
is greater than or equal to 1.0.
The Agency believes significant acute and chronic risks to
endangered birds and small mammals is not expected. Chronic exposure
to birds and small mammals is not expected. For endangered aquatic
organisms, acute levels of concern are exceeded for both fish and
invertebrate species with risk quotients of 0.07 and 16.05, respectively.
However, as noted earlier in the discussion on nonendangered aquatic
species, the likelihood of exposure is so low that acute toxicity risk to
endangered aquatic organisms is expected to be insignificant. Because
chronic exposure is not expected for aquatic organisms, significant chronic
toxicity risk to aquatic organisms is not expected.
46
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The Endangered Species Protection Program is expected to become
final in 1996. Limitations in the use of tetrachlorvinphos may be required
to protect endangered and threatened species, but these limitations have not
been defined and may be formulation specific. The Agency anticipates that
a consultation with the Fish and Wildlife Service will be conducted in
accordance with the species-based priority approach described in the
Program. After completion of consultation, registrants will be informed if
any required label modifications are necessary. Such modifications would
most likely consist of the generic label statement referring pesticide users
to use limitations contained in county Bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing tetrachlorvinphos. The Agency has
completed its review of these generic data, and has determined that, based on the
information currently available, there are data to support reregistration of all products
containing tetrachlorvinphos; however; a reregistration eligibility decision on products
registered for livestock feed-through (oral) larvicide uses cannot be made at this time for
reasons discussed below. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of
tetrachlorvinphos, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of tetrachlorvinphos. The Agency has determined that except for the use
as a feed-through larvicide for livestock, tetrachlorvinphos can be used as described in this
document without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore finds that all products containing tetrachlorvinphos
as the sole active ingredient are eligible for reregistration, with the exception of those
products labeled for the livestock feed-through use. The reregistration of particular
products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, other available information,
and the data identified in Appendix B. Although the Agency has found that all uses of
tetrachlorvinphos are eligible for reregistration, with the exception of the livestock feed-
through use, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
47
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products containing tetrachlorvinphos, if new information comes to the Agency's attention
or if the data requirements for registration or the guidelines for generating such data
change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
tetrachlorvinphos, the Agency has sufficient information on the potential health
effects of tetrachlorvinphos and on its potential for causing adverse effects in
wildlife and the environment. The Agency has determined that tetrachlorvinphos
products except those with feed-through larvicide uses, labeled and used as
specified in this RED document will not pose unreasonable risks to humans or the
environment. However, the Agency cannot make a determination as to the
eligibility of the use of tetrachlorvinphos as a livestock feed-through larvicide, for
the reason discussed below. Therefore, the Agency considers that products
containing tetrachlorvinphos for all uses except the livestock feed-through use are
eligible for reregistration.
The feed additive tolerance regulations which cover residues of
tetrachlorvinphos in livestock feeds for the feed-through use have been proposed
for revocation. The Delaney clause of Section 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) prohibits the Agency from approving food or feed additive
tolerances for a chemical that induces cancer in animals or humans within the
meaning of the Delaney clause. The Agency cannot make a determination with
regard to the eligibility of the livestock feed-through use because EPA has not
made a final determination on the proposed revocation and EPA is currently
reevaluating how it will coordinate its actions under the FFDCA and FIFRA. This
issue is discussed in greater detail below in the Regulatory Position section of this
document.
2. Eligible Uses
The domestic animal and agricultural premise treatments, general outdoor/
recreational area uses, uses on horses (provided labels restrict use from horses
meant for slaughter), dermal applications to livestock, and pet uses are eligible for
reregistration.
The Agency cannot make a determination as to the eligibility of the use of
tetrachlorvinphos as a livestock feed-through larvicide, for the reason discussed
below.
48
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B. Regulatory Position
The following is the regulatory position and rationale for the reregistration
eligibility decision for tetrachlorvinphos. Where labeling revisions are imposed, specific
language is set forth in Section V of this document.
1. Tolerance Reassessment
As part of its reregistration eligibility decision, the Agency reassessed the
tolerances of tetrachlorvinphos residues in or on food or feed commodities. The
purpose of this reassessment was to determine whether the uses of currently
registered tetrachlorvinphos products are adequately and appropriately supported
by residue tolerances as required under the FFDCA. Where deficiencies are noted,
the Agency presents a course of appropriate action to resolve the deficiencies. A
summary analysis of the current tolerances is presented in Table 21 after the
following discussion.
A feed additive regulation has been established for tetrachlorvinphos for use
as an additive in the feed of beef cattle, dairy cattle, horses, and swine at the rate
of 0.00015 Ib per 100 Ib body weight per day for beef and dairy cattle and horses,
and 0.00011 Ib per 100 Ib of body weight per day for swine (40 CFR §186.950).
The chemical name of tetrachlorvinphos as specified in 40 CFR §180.252
and §186.950, "2-chloro-l-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate",
should be replaced with "(Z)-2-chloro-l-(2,4,5-trichlorophenyl)vinyl dimethyl
phosphate."
Tolerances Listed Under 40 CFR §180.252
Currently, the tolerances specified for the raw agricultural
commodities (RACs) listed in 40 CFR §180.252 are expressed in terms of
residues of tetrachlorvinphos per se. The Agency has concluded that the
tetrachlorvinphos metabolites des-O-methyl tetrachlorvinphos, l-(2,4,5-
trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and l-(2,4,5-trichloro-phenylethanediol are of
toxicological concern and should also be regulated. The tolerance
definition should therefore be revised to include the residues of these four
metabolites of tetrachlorvinphos.
The available data are insufficient to assess the established
tolerances for residues of tetrachlorvinphos in the fat of cattle, goats, hogs,
horses, sheep, and poultry; in eggs; and in milk fat (including negligible
residues in whole milk). In October, 1993, the Agency required registrants
to submit new studies reflecting oral and dermal exposure of beef cattle,
49
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dairy cattle, and hogs, and dermal exposure of poultry to tetrachlorvinphos.
The Agency required the registrants to analyze all residues of concern in
cattle, hogs, and poultry using validated analytical methods. These data are
due by April, 1996.
Currently, there are not any registered tetrachlorvinphos products
for use on plants. All uses on food or feed plant commodities were
voluntarily canceled in 1987. The established tolerances for alfalfa; apples;
cherries; field corn fodder and forage; fresh corn (kernel plus cob with
husks removed (K+CWHR)); corn grain; pop corn fodder and forage;
sweet corn (K + CWHR); sweet corn fodder and forage; cranberries;
peaches; pears; and tomatoes should therefore be revoked. The Agency
published notice of the proposed revocation in the Federal Register. Refer
to "Tetrachlorvinphos, Terbutrin, and Etridiazole; removals"; Federal
Register, Volume 59, No. 138, July 20, 1994.
Tolerances Listed Under 40 CFR §186.950
The 40 CFR §186.950 lists no tolerances, but describes the
prescribed conditions for use of tetrachlorvinphos as an additive in the feed
of beef and dairy cattle, hogs and horses for control of fecal flies in manure
of these animals.
The available data are insufficient to assess the established feed
additive regulation for residues of tetrachlorvinphos. New studies
reflecting oral and dermal exposure of beef cattle, dairy cattle, and hogs,
and dermal exposure of poultry to tetrachlorvinphos have been required.
Because of the proposal to revoke feed additive tolerances (described
below), the Agency has deferred the requirement for the submission of new
residue studies reflecting oral exposure to tetrachlorvinphos. However,
residue data for dermal uses remain required because the Agency is
concerned about residues from tetrachlorvinphos from dermal uses. All
residues of concern should be analyzed in cattle, hogs, and poultry using
validated analytical methods.
As noted previously, in 60FR 49141 published September 21, 1995,
the Agency has proposed to revoke the feed additive tolerance set at 40
CFR § 186.950 due to the Delaney clause of FFDCA. This clause
prohibits the establishment of a regulation for any food/feed additive that
is found to induce cancer in man or animals. The Ninth Circuit Court of
Appeals ruled in July 1992 that the Agency must interpret this provision
strictly. Therefore, since EPA has concluded that tetrachlorvinphos is an
animal carcinogen within the meaning of the Delaney clause, EPA has
proposed to revoke the animal feed additive tolerance. Further, under
50
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current Agency policy if a needed food/feed additive tolerance cannot be
continued, EPA will neither register nor leave in effect a registration under
FIFRA for the associated use. EPA is currently reevaluating this policy
and a decision is expected by the end of 1995. Once EPA makes a decision
on this policy and a final determination on the proposed revocation, a
determination on the eligibility of the livestock feed-through use will be
made.
Table 21 - Tolerance Reassessment Summary
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment
Tolerances listed under 40 CFR §180.252
Alfalfa
Apples
Cattle, fat
Cattle, meat
Cattle, mbyp
Cherries
Corn, field, fodder
Corn, field, forage
Corn, fresh (K+CWHR)
Corn, grain
Corn, pop, fodder
Corn, pop, forage
Corn, sweet, (K+CWHR)
Corn, sweet, fodder
Corn, sweet, forage
Cranberries
Eggs
Goats, fat
Goat, meat
Goat, mbyp
Hogs, fat
Hog, meat
Hog, mbyp
110.0
10.0
1.5
None
None
10.0
110.0
110.0
10.0
10.0
110.0
110.0
10.0
110.0
110.0
10.0
0.1
0.5
None
None
1.5
None
None
Revoke
Revoke
TBDa
TBD
TBD
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
TBD
TBD
TBD
TBD
TBD
TBD
TBD
No registered uses exist.
Additional data are required. New magnitude of the residue
studies with cattle are required because submitted studies
do not reflect dosing rates representing the maximum
expected combined exposures and do not contain data for
all residues of concern.
No registered uses exist.
Additional data are required. New magnitude of the
residue studies with cattle, poultry and hogs are required
because submitted studies do not reflect dosing rates
representing the maximum expected combined exposures
and do not contain data for all residues of concern.
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Commodity
Horses, fat
Horses, meat
Horses, mbyp
Milk, fat (N) b
Peaches
Pears
Poultry, fat
Poultry, meat
Poultry, mbyp
Sheep, fat
Sheep, meat
Sheep, mbyp
Tomatoes
Current
Tolerance
(ppm)
0.5
None
None
0.5
0.1
10.0
0.75
None
None
0.5
None
None
5.0
Tolerance
Reassessment
(ppm)
Revoke
Revoke
Revoke
TBD
Revoke
Revoke
TBD
TBD
TBD
Revoke
Revoke
Revoke
Revoke
Comment
No additional data required for horses provided all
applicable labels prohibit treatment of horses destined for
slaughter.
See comment above referring to additional data required.
No registered uses exist.
Additional data are required. New magnitude of the residue
studies with poultry are required because submitted studies
do not contain data for all residues of concern.
No registered uses exist.
No registered uses exist.
Tolerances listed under 40 CFR §186.950
Feed items (feed additive
regulation)
--
Revoke
Delaney clause Policy -
carcinogens in animal feeds
TBD = To Be Determined. Reassessment of tolerance(s) cannot be made at this time because additional data are required.
Reflecting negligible residues in whole milk.
CODEX Harmonization
There are no Codex maximum residue limits (MRLs) established or
proposed for residues of tetrachlorvinphos. Therefore, there are no issues with
respect to compatibility of U.S. tolerances with Codex MRLs.
2. Human Health Risks and Eligibility
All uses of tetrachlorvinphos, with the exception of the oral livestock
larvicide use, are eligible for reregistration. Although there are risks posed by the
carcinogenic potential of this compound from dietary and occupational/residential
exposure, these risks are considered to be within an acceptable range for regulatory
purposes.
a. Dietary Risk
Both chronic systemic, and carcinogenic dietary risks were
calculated (see Section III.B.3.). These risks appear to be minimal when
only uses supported for reregistration are included in the assessment.
52
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For the U.S. population, the upperbound carcinogenic risk was
calculated using anticipated residues for meat, milk, poultry, and eggs and
refined by percent livestock treated estimates. The carcinogenic risk for all
published and supported uses was 4.3 x 10~5. This assumes that 100% of
the fruit and vegetable commodities consumed are imported and contain
tetrachlorvinphos at tolerance levels. However, only meat, milk, poultry,
and eggs are supported for reregistration. When only these commodities
are considered the dietary cancer risk is 1 x 10"6.
When dietary risk from chronic systemic effects was assessed, the
calculated percent RfD for the U.S. population was 59%. When only the
anticipated residues from supported uses were included, the percent RfD
for the U.S. population is 1 %.
The Agency is proceeding to revoke the feed additive tolerances as
required by the Delaney clause. When these tolerances are revoked and the
uses removed from labeling, the risk will change. It is not possible to
estimate the amount that the risk would be reduced or increased since it is
possible that some users of tetrachlorvinphos would switch from a feed-
through application to a dermal application.
b. Worker Risk
Table 9, Risk Estimates for Occupational/Residential uses of
Tetrachlorvinphos, presents the upper bound carcinogenic risk for
mixers/loaders/applicators from exposure to tetrachlorvinphos products for
ten different use scenarios. The highest calculated risk is for the low
pressure handwand scenario which is 1.3 x 10"5. This is below the
Agency's 10"4 level of concern for worker exposure.
The Agency lacks data to evaluate the risks in three worker
exposure scenarios: dusters, pellets, and impregnating material. The
Agency believes that the uses of low-pressure handwands and power
sprayers represent worst-case exposure scenarios (due to the nature of a
spraying operation) for the current uses of tetrachlorvinphos. Since risks
to workers under these worst-case scenarios do not exceed the Agency's
level of concern, it is not likely that exposures resulting from applications
of dusts, pellets, or impregnating materials will exceed the Agency's level
of concern.
To minimize worker exposure and reduce the risk to handlers,
baseline PPE are set through this document: long-sleeved shirt, long pants,
socks and shoes, and chemical-resistant gloves. The Agency expects that
these PPEs will adequately protect workers from exposures to
53
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tetrachlorvinphos. The use of chemical-resistant gloves in the PPE for
applicators using low pressure handwands should further reduce the
potential carcinogenic risk.
c. Homeowner Risk
Although there is the potential for homeowner exposures to
tetrachlorvinphos, it is unlikely that homeowners would experience
significant exposure resulting from the uses described below.
impregnated flea collars for pets
Homeowners would experience transient and brief exposures
from application of these flea collars to pets.
aerosols and dust shakers
Tetrachlorvinphos products formulated as aerosols and dusts
are intended for spot applications and do not pose significant
exposure to homeowners.
Similarly, reentry exposures to homeowners from these uses,
including the pet dusts and collars are expected to be minimal. Reentry
restrictions for homeowners are not warranted.
3. Domestic Animal Safety
Tetrachlorvinphos may be applied directly to dogs and cats to control fleas.
Data submitted to describe cholinesterase inhibition from formulated products
suggests there is little risk to pets from these applications.
4. Labeling Rationale/Risk Mitigation
a. Personal Protection Equipment (PPE) Requirements
(1) PPE for Handlers (Mixer/Loader/Applicators)
Occupational Use Products
The Agency has concerns of potential carcinogenic and
chronic risk to workers from exposure to tetrachlorvinphos.
Because of this and since there are no engineering control
requirements, such as closed systems, currently on product labeling
of tetrachlorvinphos products which would mitigate exposures to
handlers, the Agency is establishing minimum or "baseline" handler
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PPE requirements for all occupational end-use products (not
intended for homeowner use) containing this active ingredient.
The minimum (baseline) PPE requirements for handlers of
all end-use products primarily intended for occupational use of
tetrachlorvinphos are: chemical-resistant gloves and long-sleeved
shirt and long pants, socks and shoes for all handlers.
These minimum PPE requirements must then be compared
with the PPE that the Agency will designate on the basis of the
acute toxicity of each end-use product. The more stringent choice
for each type of PPE (i.e., bodywear, hand protection, footwear,
eyewear, etc.) must then be placed on the label of the end-use
product to be reregistered.
(2) Handler PPE for Homeowner-Use Products
There are several products containing tetrachlorvinphos that
are intended primarily for homeowner use (impregnated pet collar,
aerosol can, and dust shaker). At this time the Agency will not
establish minimum (baseline) PPE for homeowner-use products
based on toxicity of tetrachlorvinphos per se, since the Agency
believes exposures are likely to be much less than those from
occupational uses.
b. Entry Restrictions
(1) Entry Restrictions for Occupational-Use Products
The Agency is not establishing entry restrictions for uses of
occupational-use products on livestock, poultry, or other
commercial animals, since entry restrictions for these uses are
impractical or probably unnecessary. However, for uses of
occupational-use products on recreational sites, the Agency is
establishing an entry restriction for liquid application. This
restriction requires that sprays have dried before entering treated
areas.
(2) Entry Restrictions for Homeowner-Use Products
At this time the Agency will not establish entry restrictions
for indoor homeowner-use products, since entry restrictions for
such uses as formulated for homeowner use (i.e., impregnated
collar, aerosol can, and dust shaker) are not necessary due to very
low exposure.
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c. Product Specific Labeling Changes
A label amendment is required to prohibit treatment of horses
destined for slaughter. Uses on horses for slaughter and the resulting
potential for residues in these tissues have not have not been supported with
the submission of data.
Label amendments are required in the use directions to clarify that
weights of pesticide to be added to feed refer to weights of active ingredient
and not weights of product in order to avoid confusion in dosing.
In addition, because tetrachlorvinphos is classified as a skin
sensitizer, the Agency is requiring a warning statement be placed on labels.
5. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in 1996. Because the Agency is taking this
approach for protecting endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any requirements for product
use modifications will occur in the future under the Endangered Species Protection
Program.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of tetrachlorvinphos for
the above eligible uses has been reviewed and determined to be substantially
56
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complete. However, the Agency has required the submission of additional data as
confirmatory information. Analytical methods and data to describe the residues of
tetrachlorvinphos and its regulated metabolites for cattle, hogs, and poultry are
required. These data have been required and their due dates are listed below.
Guideline No. Study Name Due Date
171-4(d) Residue Analytical Methods 4/30/96
171-40) Magnitude of the Residue 4/30/96
in Dermally-Treated Cattle and Poultry
Because of the feed additive tolerance issue with the Delaney clause the
requirement for the livestock residue data for the feed-through use oral exposure
is deferred.
Data are also required to upgrade the Mixer/Loader/Applicator study,
(MRID # 42622301). These data must supply information to verify the storage
duration of the field samples versus the field recovery samples.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
2. General Labeling Requirements for Products
a. All Products
Because tetrachlorvinphos is classified as a skin sensitizer, the
Agency requires that the following statement appear on all tetrachlorvinphos
57
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labels in the "Hazards to Humans (and Domestic Animals)" section of the
Precautionary Statements:
"This product may cause skin sensitization reactions in
certain individuals."
b. Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing tetrachlorvinphos that are
intended primarily for occupational use:
(1) Application Restrictions:
"Do not apply this product in a way that will contact
workers or other persons, either directly or through drift.
Only protected handlers may be in the area during
application."
(2) User Safety Requirements:
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for
washables, use detergent and hot water. Keep and wash
PPE separately from other laundry."
(3) User Safety Recommendations:
• "Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if
pesticide gets inside. Then wash thoroughly and put
on clean clothing."
• "Users should remove PPE immediately after
handling this product. Wash the outside of gloves
before removing. As soon as possible, wash
thoroughly and change into clean clothing."
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c. Occupational Products Used in Recreational Areas
The following entry restriction must be added to the labels of all
products used occupationally in recreational areas:
For Liquid Application:
"Do not enter or allow others to enter the treated area until sprays
have dried."
d. Products with Feed-Through Uses
All products labeled for use on horses (currently EPA Reg. No.
56493-35) must have the following restriction:
"This product is not to be used on horses destined for slaughter."
Labels of all products with directions for use as a feed-through for
livestock (currently EPA Reg. Nos. 56493-34 and 56493-35) must be
clarified so that weights of pesticide to be added to feed refer to weights of
active ingredient and not weights of product.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell
tetrachlorvinphos products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency imposed label
changes and existing stocks requirements applicable to products they sell or distribute.
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60
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VI. APPENDICES
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A — CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 1
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) &
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
BARNS/BARNYARDS/AUCTION BARNS
Enclosed premise treatment., When
needed., Knapsack sprayer.
Enclosed premise treatment., When
needed., Power sprayer.
BEEF /RANGE/FEEDER CATTLE (MEAT)
Animal treatment (back rubber) . , When
needed., Hand held sprayer.
Animal treatment (dust) ., When needed.
Dust bag.
Animal treatment (dust) ., When needed.
Rotary duster.
Animal treatment (dust) ., When needed.
Shaker can.
Fo rm ( s )
Min . Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
Effica-
only)
EC
WP
WP/D
WP/D
EC
WP
WP/D
EC
D
D
D
D
D
D
D
D
D
D
D
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
unless noted Max.
otherwise) Dose
Use Group :
3233 Ib IK sq.ft *
3333 Ib IK sq.ft *
3333 Ib IK sq.ft *
3333 Ib IK sq.ft *
3233 Ib IK sq.ft *
3333 Ib IK sq.ft *
3333 Ib IK sq.ft *
Use Group :
UC *
UC *
UC *
UC *
UC *
.00375 Ib animal *
.0075 Ib animal *
.00375 Ib animal *
.00375 Ib animal *
.00375 Ib animal *
.0075 Ib animal *
.00375 Ib animal *
Max. #
© Max .
/crop
cycle
Apps
Rate
/year
Max. Dose [ (AI
unless
noted
otherwise) /A]
/crop
cycle
/year
Min.
Interv
(days)
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
Use
Limitations
Codes
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE
CAE
CAC, CAG
CAE
CAE
CAE
CAE
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
1
NS
NS
NS
1
NS
NS
NS
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAD
CAC
CAC
CAE
CAC
CAC
CAE
CAC
CAC
63
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APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 2
SITE Application Type, Application Form(s;
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEEF /RANGE/FEEDER CATTLE (MEAT) (con't)
Animal treatment (face rubber) ., When
needed., Hand held sprayer.
Animal treatment (spray) ., Not on label.,
Knapsack sprayer.
Animal treatment (spray) ., Not on label.,
Power sprayer.
Animal treatment (spray) ., When needed.,
Knapsack sprayer.
Animal treatment (spray) ., When needed.,
Power sprayer.
Animal treatment., When needed., Knapsack
sprayer.
Animal treatment., When needed., Power
sprayer.
Back rubber. Use code ATK. , When needed.,
By hand .
Back rubber. Use code ATK., When needed.,
Not applicable.
Ear tag. Use code ATO . , When needed.,
Pliers.
Enclosed premise treatment., When
needed., Knapsack sprayer.
i Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: INDOOR FOOD
D
EC
EC
EC
EC
WP
WP
WP/D
EC
WP
WP
WP/D
EC
EC
RTU
EC
IMPR
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.00375
.03988
.03988
.03984
.04167
.04
.04167
.03984
.04167
.04
.04167
.04209
.04209
.003988
.009061
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
.79764
animal
UC
animal
animal
animal
animal
animal
animal
animal
animal
animal
animal
animal
animal
UC
linear
ft
animal
Ib IK
sq.ft
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
NS
NS
10
NS
NS
NS
10
NS
NS
NS
NS
NS
NS
NS
AN
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAD
CAD
CAD
CAD
CAE
CAE
CAD
CAE
CAE
CAE
CAE
CAC
CAD
S09(0)
CAD
64
-------
Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEEF /RANGE/FEEDER CATTLE (MEAT) (con't)
Enclosed premise treatment., When EC
needed., Power sprayer.
Face rubber. Use code ATR, When needed., EC
Not applicable.
Feed through . , When needed . , By hand . G
Feed through . , When needed . , Not on FM?
label.
G
G
G
G
G
G
G
G
P/T
Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: INDOOR FOOD (con't)
NA .79764 Ib IK * NS NS NS NS NS NS
sq.ft
NA .003988 Ib linear * NS NS NS NS NS NS
ft
NA .198 Ib ton * NS NS NS NS NS NS
NA UC * NS NS NS NS 1 NS
NA NA * NS NS NS NS 1 NS
1.595E-04 Ib 100 *
Ib body wt
1.500E-06 Ib Ib *
body wt
NA 1.309E-06 Ib 100 * NS NS NS NS 1 NS
Ib body wt
1.929E-08 Ib Ib *
body wt
NA UC * NS NS NS NS 1 NS
1.543E-08 Ib Ib *
body wt
NA 1.550E-06 Ib Ib * NS NS NS NS 1 NS
body wt
NA 3.387E-07 Ib Ib * NS NS NS NS 1 NS
body wt
NA .004631 Ib 100 Ib * NS NS NS NS 7 NS
body wt
2.120E-08 Ib Ib *
body wt
NA 3.387E-07 Ib Ib * NS NS NS NS NS NS
body wt
NA .198 Ib ton * NS NS NS NS NS NS
NA UC * NS NS NS NS 1 NS
1.543E-08 Ib Ib *
body wt
Use
Limitations
Codes
CAD
CAD
CAC
C93
CAA
CAC
CAE
CAC
65
-------
Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 4
SITE Application Type, Application Form(s) Min. Appl . Max. Appl. Soil
Timing, Application Equipment — Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEEF /RANGE/FEEDER CATTLE (MEAT) (con't)
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
When needed., Power sprayer.
CALVES (MEAT)
Enclosed premise treatment., When
needed., Knapsack sprayer.
Enclosed premise treatment., When
needed., Power sprayer.
DAIRY CATTLE (LACTATING OR UNSPECIFIED)
Animal treatment (back rubber) . , When
needed., Hand held sprayer.
Animal treatment (dust) ., When needed.,
Dust bag.
Animal treatment (dust) ., When needed.,
P/T NA
P/T NA
P/T NA
P/T NA
EC NA
EC NA
EC NA
EC NA
EC NA
D NA
D NA
D NA
D NA
D NA
D NA
Use Group :
1.157E-08 Ib Ib *
body wt
4.630E-09 Ib Ib *
body wt
1.235E-08 Ib Ib *
body wt
UC *
.79764 Ib IK *
sq.ft
.79764 Ib IK *
sq.ft
Use Group :
.3233 Ib IK sq.ft *
.3233 Ib IK sq.ft *
Use Group :
UC *
UC *
UC *
UC *
UC *
UC *
.0075 Ib animal *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
Limitations Use
Disallowed Limitations
Codes
: INDOOR FOOD (con't)
NS
NS
NS
NS
NS
NS
NS NS NS 1 NS
NS NS NS 1 NS
NS NS NS 1 NS
NS NS NS NS NS
NS NS NS NS NS
NS NS NS NS NS
C93
CAA
CAC
CAD
CAD
: INDOOR FOOD
NS
NS
NS NS NS NS NS
NS NS NS NS NS
CAE
CAE
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS NS NS NS NS
NS NS NS 1 NS
NS NS NS 1 NS
NS NS NS NS NS
NS NS NS NS NS
NS NS NS NS NS
NS NS NS NS NS
CAD
CAC
CAE
CAC
CAE
Hand held duster.
Animal treatment (dust)., When needed.,
Rotary duster.
.00375 Ib animal
66
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 5
SITE Application Type, Application Form(s;
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
i Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
DAIRY CATTLE (LACTATING OR UNSPECIFIED) (con't)
Animal treatment (dust) ., When needed.,
Shaker can.
Animal treatment (face rubber) ., When
needed., Hand held sprayer.
Animal treatment (spray) ., Not on label.,
Knapsack sprayer.
Animal treatment (spray) ., Not on label.,
Power sprayer.
Animal treatment (spray) ., When needed.,
Power sprayer.
Back rubber. Use code ATK. , When needed.,
By hand .
Back rubber. Use code ATK., When needed.,
Not applicable.
Ear tag. Use code ATO . , When needed.,
Pliers.
Enclosed premise treatment., When
D
D
D
D
D
D
D
D
D
D
D
EC
EC
EC
EC
RTU
EC
IMPR
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.00375
.00375
.00375
.00375
.00375
.00375
.00375
.00375
.00375
.00375
.00375
.04985
.003988
.009061
.3191 Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group: INDOOR FOOD
animal
animal
animal
animal
animal
animal
animal
animal
animal
animal
animal
UC
UC
animal
UC
UC
UC
linear
ft
animal
IK sq.ft
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
*
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
1
NS
NS
NS
1
1
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAC
CAE
CAC
CAE
CAC
CAE
CAC
CAE
CAD
CAD
CAD
CAD
CAC
CAD
S09(0)
CAD
needed., Knapsack sprayer.
67
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 6
SITE Application Type, Application Form(s)
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
DAIRY CATTLE (LACTATING OR UNSPECIFIED)
Enclosed premise treatment., When
needed., Power sprayer.
Face rubber. Use code ATR, When needed.
Not applicable.
Feed through . , When needed . , By hand .
Feed through . , When needed . , Not on
label.
(con't)
EC
WP
WP/D
EC
EC
WP
WP/D
EC
G
FM?
G
G
G
G
G
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group :
NA .3233 Ib IK sq.ft *
NA .3333 Ib IK sq.ft *
NA .3333 Ib IK sq.ft *
NA .3191 Ib IK sq.ft *
NA .3233 Ib IK sq.ft *
NA .3333 Ib IK sq.ft *
NA .3333 Ib IK sq.ft *
NA .003988 Ib linear *
ft
NA .198 Ib ton *
NA UC *
NA NA *
.004631 Ib 100 Ib *
body wt
1.500E-06 Ib Ib *
body wt
NA 1.309E-06 Ib 100 *
Ib body wt
1.198E-07 Ib Ib *
body wt
NA UC *
1.543E-08 Ib Ib *
body wt
NA 3.387E-07 Ib Ib *
body wt
.198 Ib ton *
NA 3.387E-07 Ib Ib *
body wt
Max. tt Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
: INDOOR FOOD (con't)
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Min. Restr. Geographic Limitations
Interv Entry Allowed Disallowed
(days) Interv
[day(s) ]
NS NS
NS NS
7 NS
NS NS
NS NS
NS NS
7 NS
NS NS
1 NS
1 NS
1 NS
1 NS
1 NS
1 NS
1 NS
Use
Limitations
Codes
CAE
CAC, CAG
CAD
CAE
CAC, CAG
CAD
CAC
C93
CAA
CAC
CAE
68
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 7
SITE Application Type, Application
Timing, Application Equipment —
Fo rm ( s )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
DAIRY CATTLE (LACTATING OR UNSPECIFIED)
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
only)
(con't)
G
G
P/T
P/T
P/T
P/T
EC
WP/D
WP/D
Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: INDOOR FOOD (con't)
NA 2.120E-08 Ib Ib * NS NS NS NS 7 NS
body wt
NA 1.476E-04 Ib 100 * NS NS NS NS NS NS
Ib body wt
.001595 Ib animal *
3.387E-07 Ib Ib *
body wt
NA UC * NS NS NS NS 1 NS
1.543E-08 Ib Ib *
body wt
NA 1.929E-08 Ib Ib * NS NS NS NS 1 NS
body wt
NA 4.630E-09 Ib Ib * NS NS NS NS 1 NS
body wt
NA 1.235E-08 Ib Ib * NS NS NS NS 1 NS
body wt
NA .79764 Ib IK * NS NS NS NS NS NS
sq.ft
NA .8333 Ib IK sq.ft * NS NS NS NS 7 NS
NA .8333 Ib IK sq.ft * NS NS NS NS 7 NS
Use
Limitations
Codes
C93
CAA
CAC
CAD
CAC, CAG
CAC, CAG
When needed., Power sprayer.
EGG HANDLING ROOMS (COMMERCIAL)
Enclosed premise treatment., When
needed., Duster.
Enclosed premise treatment., When
needed., Knapsack sprayer.
Enclosed premise treatment., When
needed., Power sprayer.
HOG/PIG/SWINE (MEAT)
Animal bedding/litter treatment., When
needed., Hand held duster.
WP/D
WP/D
WP/D
Use Group: INDOOR FOOD
UC * NS NS
.08333 Ib IK
sq.ft
.08333 Ib IK
sq.ft
NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
Use Group: INDOOR FOOD
.2 Ib IK sq.ft * NS NS
CAC, CAG
CAC, CAG
CAC, CAG
69
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page
SITE Application Type, Application Form(s) Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min.
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days)
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
HOG/PIG/SWINE (MEAT) (con't)
Animal bedding/litter treatment., When
needed., Power duster.
Animal treatment (dust) ., When needed.,
Hand held duster.
Animal treatment (dust) ., When needed.,
Power duster.
Animal treatment (dust) ., When needed.,
Rotary duster.
Animal treatment (dust) ., When needed.,
Shaker can.
Animal treatment (spray) ., Not on label.
Use Group: INDOOR FOOD
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
. , EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.0075
.2 Ib
.2 Ib
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.0075
.01992
Ib animal
IK sq.ft
IK sq.ft
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
UC
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
Ib animal
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
1
14
14
14
14
14
1
14
14
14
NS
1
14
14
1
14
NS
14
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAC
CAE
CAC
CAE
CAC
CAC
CAE
CAE
CAC
CAE
CAC
CAE
CAD
Knapsack sprayer.
Animal treatment (spray)., Not on label.
Powe r sp raye r.
.01992 Ib animal
70
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) &
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
HOG/PIG/SWINE (MEAT) (con't)
Animal treatment (spray) ., When needed
Knapsack sprayer.
Animal treatment (spray) ., When needed
Power sprayer.
Fo rm ( s )
Min . Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
Effica-
only)
WP
WP
WP/D
WP
WP
WP/D
Animal treatment., When needed., Knapsack EC
sprayer.
Animal treatment., When needed., Power
sprayer.
Enclosed premise treatment., When
needed., Knapsack sprayer.
Enclosed premise treatment., When
needed., Power sprayer.
Feed through . , When needed . , By hand .
Feed through . , When needed . , Not on
label.
EC
EC
EC
WP/D
EC
EC
WP/D
G
G
G
G
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
unless noted Max.
otherwise) Dose
Use Group :
.02083 Ib animal *
.02 Ib animal *
.02083 Ib animal *
.02083 Ib animal *
.02 Ib animal *
.02083 Ib animal *
.02105 Ib animal *
.02105 Ib animal *
3233 Ib IK sq.ft *
3191 Ib IK sq.ft *
3333 Ib IK sq.ft *
3233 Ib IK sq.ft *
3191 Ib IK sq.ft *
3333 Ib IK sq.ft *
.198 Ib ton *
UC *
4.653E-05 Ib *
animal
UC *
UC *
4.653E-05 Ib *
animal
.198 Ib ton *
Max.
@ Max
/crop
cycle
# Apps
. Rate
/year
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose
[(AI
unless noted
otherwise) /A]
/crop
cycle
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
/year
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Min.
Interv
(days)
14
14
NS
14
14
NS
14
14
14
NS
NS
14
NS
NS
1
1
1
1
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use
Limitations
Codes
CAE
CAE
CAE
CAE
CAE
CAE
CAE
CAD
CAC,
CAE
CAD
CAC,
CAC
C93
CAC
CAG
CAG
71
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APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 10
SITE Application Type, Application Form(s;
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
HOG/PIG/SWINE (MEAT) (con't)
Litter and bedding treatment. Use code
AAL . , When needed., Hand held duster.
Litter and bedding treatment. Use code
AAL., When needed., Power duster.
Litter and bedding treatment. Use code
AAL., When needed., Rotary duster.
Litter and bedding treatment. Use code
AAL., When needed., Shaker can.
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
When needed., Power sprayer.
POULTRY (EGG /MEAT)
Animal equipment treatment., When
needed., Paintbrush.
Animal treatment (dust) ., When needed.,
G
G
D
D
D
D
D
D
D
EC
EC
D
D
D
D
WP
WP/D
D
i Min. Appl . Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.2 Ib
.2 Ib
.2 Ib
.2 Ib
.2 Ib
.2 Ib
.2 Ib
Use Group :
UC *
UC *
IK sq.ft *
IK sq.ft *
IK sq.ft *
IK sq.ft *
IK sq.ft *
IK sq.ft *
IK sq.ft *
.79764 Ib IK *
sq.ft
.79764 Ib IK *
2 .4
2 .4
2.4 Ib
.3
2 .4
.1
.1042
.0006
sq.ft
Use Group :
Ib IK ft *
Ib IK ft *
IK sq.ft *
Ib IK ft *
Ib IK ft *
Ib IK ft *
Ib IK ft *
Ib bird *
Max. # Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: INDOOR FOOD (con't)
NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
14
14
14
14
14
14
14
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAE
CAE
CAC
CAE
CAC
CAE
CAD
CAD
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE
CAC
CAE
CAE
CAE
Dust box.
72
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 11
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) &
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (EGG /MEAT) (con't)
Animal treatment (dust) ., When needed.
Rotary duster.
Animal treatment (dust) ., When needed.
Shaker can.
Animal treatment (spray) ., When needed
Knapsack sprayer.
Fo rm ( s )
Effica-
only)
D
D
WP
WP/D
D
D
D
D
D
D
D
D
D
D
EC
WP
Min . Appl .
Rate (AI un
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA 3.
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group :
.0006 Ib bird *
.0006 Ib bird *
.15625 Ib 100 *
birds
.15625 Ib 100 *
birds
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.0001 Ib bird *
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
*
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.0001 Ib bird *
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
988E-04 Ib bird *
.0004 Ib bird *
Max. tt Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
: INDOOR FOOD (con't)
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Min. Restr. Geographic Limitations
Interv Entry Allowed Disallowed
(days) Interv
[day(s) ]
NS NS
NS NS
NS NS
NS NS
1 NS
14 NS
14 NS
NS NS
NS NS
1 NS
14 NS
14 NS
NS NS
NS NS
14 NS
14 NS
Use
Limitations
Codes
CAC
CAE
CAE
CAE
CAC
CAC
CAE
CAE
CAC
CAC
CAE
CAE
CAD
CAE
73
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 12
SITE Application Type, Application Form(s;
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (EGG /MEAT) (con't)
Animal treatment (spray) ., When needed.,
Power sprayer.
Brush-on., When needed., Brush.
Brush- on., When needed., Paintbrush.
Dust., When needed., Rotary duster.
Enclosed premise treatment., When
needed., Brush.
Enclosed premise treatment., When
needed., High pressure sprayer.
Enclosed premise treatment., When
needed., Knapsack sprayer.
Enclosed premise treatment., When
needed., Power sprayer.
Equipment treatment., When needed.,
Paintbrush .
i Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: INDOOR FOOD
WP/D
EC
WP
WP/D
WP
D
D
WP/D
EC
EC
EC
WP
WP
WP/D
EC
EC
WP
WP
WP/D
D
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.005 gal bird
3.988E-04 Ib bird
.0004 Ib bird
.005 gal bird
.1042 Ib IK ft
.3 Ib IK ft
.0006 Ib bird
.1042 Ib IK ft
.79764 Ib IK
sq.ft
.09971 Ib IK
linear ft
.1616 Ib IK sq.ft
.3333 Ib IK sq.ft
.8 Ib IK sq.ft
.3333 Ib IK sq.ft
.09971 Ib IK
linear ft
.1616 Ib IK sq.ft
.8333 Ib IK sq.ft
.8 Ib IK sq.ft
.3333 Ib IK sq.ft
2.4 Ib IK linear
ft
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
14
14
14
NS
14
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAD
CAE
CAE
CAE
CAE
CAC, CAG
CAD
CAD
CAE
CAE
CAC, CAG
CAD
CAE
CAE
CAC, CAG
CAC
74
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 13
SITE Application Type, Application Form(s;
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (EGG /MEAT) (con't)
Equipment treatment., When needed.,
Rotary duster.
Litter and bedding treatment. Use code
AAL . , When needed., Duster.
Litter and bedding treatment. Use code
AAL., When needed., Knapsack sprayer.
Litter and bedding treatment. Use code
AAL., When needed., Power sprayer.
Litter and bedding treatment. Use code
AAL., When needed., Rotary duster.
Litter and bedding treatment. Use code
AAL., When needed., Shaker can.
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
When needed., Power sprayer.
i Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: INDOOR FOOD
D
D
WP
WP
WP/D
WP
WP/D
D
D
D
D
D
D
D
D
EC
EC
WP/D
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.3 Ib
.156
.08 Ib
1.6 Ib
.08 Ib
1.6 Ib
.3 Ib
.3 Ib
.3 Ib
.3 Ib
.3 Ib
.3 Ib
.1 Ib
.3 Ib
IK sq.ft
25 Ib 100
birds
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
IK sq.ft
.79764 Ib IK
.8081 Ib
.8333 Ib
sq.ft
IK sq.ft
IK sq.ft
.79764 Ib IK
sq.ft
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
NS
NS
NS
NS
1
14
NS
NS
NS
14
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAC
CAE
CAE
CAE
CAE
CAC
CAE
CAC
CAE
CAE
CAE
CAD
CAE
CAC, CAG
CAD
75
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 14
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) &
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (EGG /MEAT) (con't)
POULTRY (MEAT)
Animal equipment treatment., When
needed., Paintbrush.
Animal treatment (dust) ., When needed.
Dust box.
Animal treatment (dust) ., When needed.
Rotary duster.
Animal treatment (dust) ., When needed.
Shaker can.
Animal treatment (spray) ., When needed
Knapsack sprayer.
Animal treatment (spray) ., When needed
Power sprayer.
Enclosed premise treatment., When
Fo rm ( s )
Min . Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
Effica-
only)
EC
WP/D
D
WP/D
D
D
WP/D
D
D
D
D
EC
WP/D
EC
WP/D
EC
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA 3
NA 4
NA 3
NA 4
NA
unless noted Max.
otherwise) Dose
Use Group :
8081 Ib IK sq.ft *
8333 Ib IK sq.ft *
Use Group :
2 .4 Ib IK ft *
2.4 Ib IK sq.ft *
.1042 Ib IK ft *
.0006 Ib bird *
.0006 Ib bird *
.15625 Ib 100 *
birds
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.009999 Ib 100 *
birds
.988E-04 Ib bird *
.167E-04 Ib bird *
.988E-04 Ib bird *
.167E-04 Ib bird *
.79764 Ib IK *
Max.
@ Max
/crop
cycle
# Apps
. Rate
/year
: INDOOR FOOD
NS
NS
NS
NS
Max. Dose
[(AI
unless noted
otherwise) /A]
/crop
cycle
(con't)
NS
NS
/year
NS
NS
Min.
Interv
(days)
NS
NS
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
Use
Limitations
Codes
CAE
CAC, CAG
: INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
NS
NS
14
14
14
14
14
NS
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE
CAE
CAE
CAE
CAE
CAD
CAE
CAD
CAE
CAD
needed., High pressure sprayer.
Enclosed premise treatment., When
needed., Knapsack sprayer.
sq.ft
.09971 Ib IK * NS
linear ft
76
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 15
SITE Application Type, Application Form(s) Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (MEAT) (con't)
Enclosed premise treatment., When
needed., Power sprayer.
Equipment treatment., When needed.,
Paintbrush .
Litter and bedding treatment. Use code
AAL . , When needed., Electric duster.
Litter and bedding treatment. Use code
AAL., When needed., Knapsack sprayer.
Litter and bedding treatment. Use code
AAL., When needed., Mechanical duster.
Litter and bedding treatment. Use code
AAL., When needed., Power sprayer.
Litter and bedding treatment. Use code
AAL., When needed., Rotary duster.
Litter and bedding treatment. Use code
AAL., When needed., Shaker can.
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
When needed., Power sprayer.
Limitations Use
Disallowed Limitations
Codes
Use Group: INDOOR FOOD (con't)
EC NA
EC NA
EC NA
D NA
WP/D NA
WP/D NA
WP/D NA
WP/D NA
D NA
D NA
WP/D NA
D NA
EC NA
EC NA
EC NA
.1616 Ib IK sq.
.09971 Ib
linear
.1616 Ib IK sq.
.3 Ib IK sq.
.2344 Ib IK sq.
1.6 Ib IK sq.
.2344 Ib IK sq.
1.6 Ib IK sq.
.3 Ib IK sq.
.3 Ib IK sq.
.2344 Ib IK sq.
.1 Ib IK sq.
.79764 Ib
sq.
.8081 Ib IK sq.
.79764 Ib
sq.
ft * NS NS NS NS NS NS
IK * NS NS NS NS NS NS
ft
ft * NS NS NS NS NS NS
ft * NS NS NS NS 14 NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS 14 NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS NS NS
ft * NS NS NS NS NS NS
IK * NS NS NS NS NS NS
ft
ft * NS NS NS NS NS NS
IK * NS NS NS NS NS NS
ft
CAE
CAD
CAE
CAE
CAE
CAE
CAE
CAE
CAE
CAE
CAD
CAE
CAD
.8081 Ib IK sq.ft
77
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 16
SITE Application Type, Application Forn
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL)
Animal treatment (dust)., When needed., D
Hand held duster.
Animal treatment (spray)., When needed., WP/D
Knapsack sprayer.
Animal treatment (spray)., When needed., WP/D
Powe r sp raye r.
Premise treatment., When needed., EC
Knapsack sprayer.
Premise treatment., When needed., Power EC
sprayer.
Premise treatment., Not on label., EC
Knapsack sprayer.
Premise treatment., Not on label., Power EC
sprayer.
CATS (ADULTS/KITTENS)
Animal bedding/litter treatment., When PRL
needed., Aerosol can.
Animal bedding/litter treatment., When D
needed., By hand.
Animal bedding/litter treatment., When
needed., Hand held duster.
Animal bedding/litter treatment., When
needed., Mist sprayer.
Animal treatment (collar)., When needed., IMPR
By hand.
Use Group: INDOOR NON-FOOD
UC * NS NS NS
.05 Ib IK sq.ft * NS NS NS
.05 Ib IK sq.ft * NS NS NS
.3335 Ib IK sq.ft * NS NS NS
.3335 Ib IK sq.ft * NS NS NS
Use Group: TERRESTRIAL NON-FOOD
.996 Ib A * NS NS NS
CROP
NS
.996 Ib A
NS NS
NS
Use Group: INDOOR RESIDENTIAL
D
D
RTU
IMPR
IMPR
IMPR
NA
NA
NA
NA
NA
NA
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
7
120
150
60
NS
NS
NS
NS
NS
NS
78
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 17
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) &
cy Influencing Factor (Antimicrobial
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CATS ( ADULTS /KITTENS ) ( con ' t )
Animal treatment (dust) ., When needed.
By hand .
Animal treatment (dust) ., When needed.
Fo rm ( s )
Effica-
only)
D
D
D
D
D
Min . Appl .
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
NA
Max. Appl.
Rate (AI
unless noted
otherwise)
Use
UC
UC
UC
UC
UC
Soil
Tex.
Max.
Dose
Group :
*
*
*
*
*
Max.
@ Max
/crop
cycle
# Apps
. Rate
/year
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
: INDOOR RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
Min.
Interv
(days)
7
7
NS
NS
7
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
Use
Limitations
Codes
CAC
CAE
Hand held duster.
Animal treatment (spray)., When needed.
Aerosol can.
Enclosed premise treatment., When
needed., Aerosol can.
Indoor premise treatment., When needed.
Aerosol can.
Indoor premise treatment., When needed.
Mist sprayer.
Sponge-on., When needed., Sponge.
DOGS/CANINES (ADULTS/PUPPIES)
Animal bedding/litter treatment., When
needed., Aerosol can.
Animal bedding/litter treatment., When
needed., By hand.
D
D
PRL
RTU
PRL
PRL
PRL
RTU
D
NA
NA
NA
NA
NA
NA
NA
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
NS
NS
NS
NS
NS
UC
NS NS
UC * NS
UC * NS
.04409 Ib animal *
NS
NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS
UC * NS NS
NS
NS
NS NS
NS NS
NS NS
NS 7
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
UC * NS
NS
79
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 18
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
DOGS/CANINES (ADULTS/PUPPIES) (con't)
Animal bedding/litter treatment., When
needed., Hand held duster.
Animal bedding/litter treatment., When
needed., Mist sprayer.
Animal treatment (collar)., When needed.
By hand.
Animal treatment (dust)., When needed.,
By hand.
Use Group: INDOOR RESIDENTIAL (con't)
Animal treatment (dust)., When needed.,
Hand held duster.
Animal treatment (spray)., When needed.
Aerosol can.
Animal treatment (spray)., When needed.
Mist sprayer.
Indoor premise treatment., When needed.
Aerosol can.
UC * NS
UC * NS
UC * NS
NS
UC * NS
NS
IMPR
D
D
D
D
D
D
D
PRL
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
60
7
7
NS
NS
7
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Indoor premise treatment., When needed.
Mist sprayer.
Sponge-on., When needed., Sponge.
HORSES (SHOW/RACE/SPECIAL/PONIES)
Animal treatment (dust)., When needed.,
Hand held duster.
UC * NS
.04409 Ib animal *
NS
NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS
80
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 19
SITE Application Type, Application Form(s) Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HORSES (SHOW /RACE/SPECIAL/PONIES) (con't)
Animal treatment (dust) ., When needed., D NA
Rotary duster.
Animal treatment (dust) ., When needed., D NA
Shaker can.
D NA
Animal treatment (spray) ., When needed., RTU NA
Sprayer.
Animal treatment (wound) ., When needed., RTU NA
By hand .
Animal treatment (wound) ., When needed., RTU NA
Cloth.
Enclosed premise treatment (spot) ., When D NA
needed., Shaker can.
Enclosed premise treatment., When D NA
needed., Rotary duster.
Enclosed premise treatment., When D NA
needed., Shaker can.
Feed through . , When needed . , Not on G NA
label.
G NA
G NA
G NA
P/T NA
Use Group: INDOOR NON-FOOD (con't)
.00375 Ib animal * NS NS NS NS NS NS
.00375 Ib animal * NS NS NS NS NS NS
.00375 Ib animal * NS NS NS NS NS NS
.001039 Ib animal * NS NS NS NS AN NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
.00375 Ib animal * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
1.852E-08 Ib Ib * NS NS NS NS 1 NS
body wt
1.543E-08 Ib Ib * NS NS NS NS 1 NS
body wt
2.395E-06 Ib Ib * NS NS NS NS 1 NS
body wt
3.809E-06 Ib 100 * NS NS NS NS NS NS
Ib body wt
UC * NS NS NS NS 1 NS
Limitations Use
Disallowed Limitations
Codes
CAE
CAE
CAE
CAE
C93
CAE
P/T
P/T
7.624E-09 Ib Ib *
body wt
9.753E-09 Ib Ib * NS NS
body wt
81
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 20
SITE Application Type, Application
Timing, Application Equipment —
Form(s) Min. Appl .
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
otherwise)
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
Codes
HORSES (SHOW/RACE/SPECIAL/PONIES) (con't)
Rub-on., When needed., By hand. RTU
Rub-on., When needed., Cloth. RTU
Wipe-on/wiper treatment., When needed., RTU
Cloth.
Wipe-on/wiper treatment., When needed., RTU
Glove.
HOUSEHOLD/DOMESTIC DWELLINGS
Spot treatment., When needed., Shaker D
can.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Indoor premise treatment., When needed., PRL
Aerosol can.
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
EC
Outdoor general surface spray., Not on
label., Knapsack sprayer.
Outdoor general surface spray., Not on
label., Power sprayer.
Manure treatment. Use site code 40001.,
When needed., Knapsack sprayer.
Manure treatment. Use site code 40001.,
When needed., Power sprayer.
EC
NA
NA
NA
Use Group: INDOOR NON-FOOD (con't)
UC * NS NS NS NS NS
UC * NS NS NS NS NS
.001039 Ib animal * NS NS NS NS AN
UC
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
49.8 Ib A * NS NS NS
49.8 Ib A
NS
NS
NS
Use Group: OUTDOOR RESIDENTIAL
NS
NS
NS
NS
NS
EC
WP
WP
WP/D
EC
WP
WP
NA
NA
NA
NA
NA
NA
NA
.83375
.8333 Ib
.8 Ib
.8333 Ib
IK
IK
IK
.83375
.8333 Ib
.8 Ib
IK
IK
Ib
sq.
sq.
sq.
sq.
Ib
sq.
sq.
sq.
IK
ft
ft
ft
ft
IK
ft
ft
ft
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
7
7
NS
7
7
NS
NS
NS
NS
NS
NS
NS
CAE
CAE
CAD
82
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 21
SITE Application Type, Application
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr.
Rate (AI Tex. ® Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
Limitations
Codes
MANURE (con't)
Feed through., When needed., Not on
label.
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Mound treatment., When needed., Shaker
can.
PET LIVING/SLEEPING QUARTERS
Animal bedding/litter treatment., When
needed., Aerosol can.
Enclosed premise treatment., When
needed., By hand.
Enclosed premise treatment., When
needed., Hand held duster.
Indoor premise treatment., When needed.,
Aerosol can.
RECREATIONAL AREAS
Outdoor general surface spray., Not on
label., Knapsack sprayer.
Outdoor general surface spray., Not on
label., Power sprayer.
Outdoor general surface spray., When
needed., Knapsack sprayer.
Outdoor general surface spray., When
needed., Power sprayer.
Outdoor premise treatment., When needed.
Knapsack sprayer.
WP/D
WP
WP/D
WP
WP
NA
NA
Use Group: OUTDOOR RESIDENTIAL (con't)
.8333 Ib IK sq.ft * NS NS NS NS
Use Group: INDOOR NON-FOOD
3.422E-07 Ib Ib * NS NS NS NS
body wt
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS
UC
NS NS
NS
UC * NS
Use Group: TERRESTRIAL NON-FOOD CROP
.996 Ib A * NS NS
.996 Ib A * NS NS
1 Ib A * NS NS
.05 Ib IK sq.ft * NS NS
1 Ib A * NS NS
1.042 Ib A * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE
CAE
CAE
83
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Report Run Date: 07/14/95 - Time 09:57
APPENDIX A - CASE 0321, [Tetrachlorvinphos] Chemical 083701 [Tetrachlorvinphos]
LUIS 2.1 - Page 22
SITE Application Type, Application Form(s)
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min . Appl .
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [ (AI
Rate (AI Tex. ® Max . Rate unless noted
unless noted Max. /crop /year otherwise) /A]
otherwise) Dose cycle /crop /year
cycle
Min . Restr . Geographic Limitations
Interv Entry Allowed Disallowed
(days) Interv
[day(s) ]
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
RECREATIONAL AREAS (con't)
Outdoor premise treatment., When needed., WP
Power sprayer.
REFUSE/SOLID WASTE SITES (OUTDOOR)
Disposal treatment., When needed., WP
Knapsack sprayer.
WP/D
Disposal treatment., When needed., Power WP
sprayer.
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
1.042 Ib A * NS
NS
NS
NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.8 Ib IK sq.ft * NS NS NS NS
NA .8333 Ib IK sq.ft * NS NS
NA .8 Ib IK sq.ft * NS NS
NS
NS
NS
NS
NS
NS
CAE
CAC, CAG
CAE
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Soil Tex. Max. Dose
Max. tt Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
F Fine
O Others
FORMULATION CODES
D DUST
EC EMULSIFIABLE CONCENTRATE
FM? FORM NOT IDENTIFIED
G GRANULAR
IMPR IMPREGNATED MATERIAL
P/T PELLETED/TABLETED
PRL PRESSURIZED LIQUID
RTU LIQUID-READY TO USE
WP WETTABLE POWDER
WP/D WETTABLE POWDER/DUST
ABBREVIATIONS
AN
NA
NS
UC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
84
-------
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to " . 0001234"
USE LIMITATIONS CODES
C93
CAA
CAC
CAD
CAE
CAG
S09
Do not apply directly to water.
Do not apply to any body of water.
Keep out of lakes, streams, and ponds.
Do not apply directly to water or wetlands.
Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).
Do not apply where runoff is likely to occur.
day(s) preslaughter interval.
NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS, DAYS, ETC.) DESCRIBED IN THE LIMITATION.
85
-------
86
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Tetrachlorvinphos covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Tetrachlorvinphos in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in 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 in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). 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 appendix for a complete citation of the study.
87
-------
88
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Tetrachlorvinphos
REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process.
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flammability
63-16 Explodability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41222501, 41222502, 43160601
41222501, 42013001
40491301, 41222501, 42013001
40924701, 41222502, 43160601, 43160602
41222502
41222502, 42013002, 42275201, 42679201, 43160601
41222503
41222503
41222503
41222503
Not Applicable
41222503
41222503
41222503
Not Applicable
41222503
41222503
41222503
Not Applicable
Not Applicable
Not Applicable
89
-------
Data Supporting Guideline Requirements for the Reregistration of Tetrachlorvinphos
REQUIREMENT
63-17
63-18
63-19
63-20
Storage stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN CITATION(S)
All
All
All
All
41222503, 42013003, 42407801
Not Applicable
Not Applicable
41222503, 42013003
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1D
72-2A
72-3A
72-3B
72-3C
141-1
141-2
Acute Avian Oral -Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Honey Bee Acute Contact
Honey Bee Residue on Foliage
B, C, K
B, C, K
B, C, K
B, C, K
B, C, K
00160000
00022923
00022923
40098001
40098001
41257101
40228401
40228401
40228401
00036935
05000837
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
All
All
All
All
All
All
41222504
41222505
00138933
41222506
41222507
41377902, 42981001
00079791, 41905901
90
-------
Data Supporting Guideline Requirements for the Reregistration of Tetrachlorvinphos
REQUIREMENT
USE PATTERN CITATION(S)
81-8 Acute Neurotoxity - Rat
82-1 90-Day Feeding - Rodent
82-3 90-Day Dermal - Rodent
83-1A Chronic Feeding Toxicity - Rodent
83-1B Chronic Feeding Toxicity - Non-Rodent
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Penetration
86-1 Domestic Animal Safety
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3 Dermal Passive Dosimetry Exposure
133-4 Inhalation Passive Dosimetry Exposure
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
162-1 Aerobic Soil Metabolism
163-1 Le aching/Ad sorption/De sorption
42912501
B, L 43371201
41342001
B, L 00112525,42980901
B, L 00077819, 42679401
B, L 00117443,42980901
B, L 00117443,00126039
B, L 40152701, 42520101
B, L 00127831
B, L 00077802, 42054301
B, C, K, L, M 41222508
B, C, K, L, M 41312901
B, C, K, L, M 42156401
B,L 41988401
42111501
40436601, 41810101, 41810102
42622301
42622301
All 41222501, 41222502, 43160601
All 41929101
B, C, K 00077821, 42082401
B, C, K 41681301
91
-------
Data Supporting Guideline Requirements for the Reregistration of Tetrachlorvinphos
REQUIREMENT
USE PATTERN CITATION(S)
164-A-SS Dissipation of Residues in Excrement
RESIDUE CHEMISTRY
171-4B
171-4
C&D
171-4E
171-4J
Nature of Residue - Livestock
Residue Analytical Method - Plants/Animals
Storage Stability
Magnitude of Residues - Meat/Milk/Poultry/Egg
B
B
B
B
42848501
00116020, 00117354, 00120147, 00120204, 42828801, 42828802,
42828803
00038458, 00077812, 00077814, 00077816, 00115939, 00116020,
00116553, 00117329, 00117340, 00117351, 00117354, 00117389,
00118265, 00120147, 00120200, 00120205, 00120206, 00120229,
00130705, 00133913, 05004211
00117329, 00117354, 00117361, 00117389, 00133913
00038458,
00117354,
00120227,
00084189,
00117389,
05006630
00115939, 00117298, 00117339, 00117340,
00118265, 00120200, 00120206, 00120225,
92
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. 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, are 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 also attempted 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 whenever a 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 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
identifying 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 standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, 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 the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (19??),
the Agency was unable to determine or estimate the date of the document.
93
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c. Title. In some cases, it has been necessary for the 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. 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," which stands 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.
94
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BIBLIOGRAPHY
MRID
CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of Environmental
Pollutants to Birds: Special Scientific Report-Wildlife No. 191. (U.S. Dept. of the Interior, Fish
and Wildlife Service, Patuxent Wildlife Research Center; unpublished report)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides and Other
Agricultural Chemicals to Honey Bees: Laboratory Studies. By University of California, Dept. of
Entomology. ?: UC, Cooperative Extension. (Leaflet 2287; published study.)
00038458 Schultz, D.R.; Rawn, D.T.; DeKay, D.E. (1973) Residues of SD 8447 in Biopsy Fat Samples
from Pigs Fed 400 and 800 PPM Stirofos in the Ration: TIR-26-005-73. (Unpublished study
received Jun 27, 1980 under OH5269; prepared by Shell Development Co., submitted by Diamond
Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:242780-G)
00077802 Eisenlord, G.; Loquvam, G.S.; Nemenzo, J.; et al. (1966) Results of Reproduction Study of Rats
Fed Diets Containing SD 8447 Insecticide over Three Generations: Report No. 28. (Unpublished
study received May 23, 1967 under 8G0665; prepared by Hine Laboratories, Inc., submitted by
Shell Chemical Co., Washington, D.C.; CDL:091166-M)
00077812 Shell Development Company (1966) Residue Determination of SD 8447 and Its Low-melting
Isomer SD 13462 in Agricultural Crops: GLC Electron Capture Method. Analytical method
MMS-71/66 dated Jan 21, 1966. (Unpublished study received May 23, 1967 under 8G0665;
CDL:091166-AE)
00077814 Shell Development Company (1966) Residue Determination of SD 8447 and Its Low-melting
Isomer SD 13462 in Agricultural Crops: GLC Phosphorus Detector Method. Analytical method
MMS-80/66 dated Dec 1966. (Unpublished study received May 23, 1967 under 8G0665;
CDL:091166-AG)
00077816 Shell Development Company (1967) Residue Determination of Acid Hydrolizable Conjugate
Metabolites from SD 8447 Treated Crops: GLC Electron-capture method. Analytical method
MMS-85/67 dated Apr 1967. (Unpublished study received May 23, 1967 under 8G0665;
CDL:091166-AI)
00077819 Doyle, R.L.; Teske, R.H.; Elsea, J.R. (1968) Two-year Dietary Administration of SD 8447 to
Dogs: P-99A. (Unpublished study received Aug 17, 1968 under 9F0739; prepared by Hill Top
Research, Inc., submitted by Shell Chemical Co., Washington, D.C.; CDL: 091273-A)
00077821 Beynon, K.I.; Wright, A.N. (1968) The Breakdown of the Insecticide Gardona (SD 8447,
2-Chloro-l-(2',4',5'-trichlorophenyl)vinyl Dimethyl Phosphate) on Plants and in Soils: WP-193-68.
(Unpublished study received Aug 17, 1968 under 9F0739; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:091273-F)
95
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BIBLIOGRAPHY
MRID
CITATION
00079791 El-sebae, A.H.; Soliman, S.A.; Elamayem, M.A.; et al. (1977) Neurotoxicity of
organophosphorus insecticides leptophos and EPN. Journal of Environmental Science and Health
B 12(4):269-288. (Also~In~unpublished submission received on unknown date under 352-338;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:236741-G)
00084189 Ivey, M.C.; DeVaney, J.A.; Me, G.W. (1981) Residues of Stirofos (Rabon-(R)ae) in Eggs of
Laying Hens Treated for Northern Fowl Mite Control by Dipping. (U.S. Dept. of Agriculture,
Science and Education Administration, Agricultural Research, Veterinary Toxicology and
Entomology Research Laboratory; unpublished study; CDL:245949-A)
00112525 Walker, A.; Hunter, C. (1967) The Oral Toxicity of the Halophenyl Vinyl Phosphate Insecticide
Gardona (SD 8447): Two Year Oral Experiment in Rats: Research Report R(T)-9-67.
(Unpublished study received Aug 17, 1968 under 9F0739; prepared by Shell Research Ltd., Eng.,
submitted by Shell Chemical Co., Washington, DC; CDL:091274-O)
00115939 Shell Chemical Co. (1972) Residue Data in Reply to EPA's July 10, 1972 Letter of Special Review
for Ciovap EC Insecticide. (Compilation; unpublished study received Sep 20, 1972 under 201-244;
CDL:000948-A)
00116020 Shell Chemical Co. (1970) Residue Data Developed from the Use of Dairy Cattle: CRabon|.
(Compilation; unpublished study received Jan 19, 1970 under 1F1090; CDL:090850-B)
00116553 Shell Chemical Co. (1971) The Results of Tests on the Amount of Residues Remaining, Including
a Description of the Analytical Methods Used: CGardona| . (Compilation; unpublished study
received Oct 12, 1972 under 2F1281; CDL:091818-B)
00117298 Miller, R.; Gordon, C. (19??) Effect of feeding Rabon to dairy cows over extended periods.
Journal of Economic Entomology 66(1): 135-138. (Also In unpublished submission received Oct
17, 1973 under 201-359; submitted by Shell Chemical Co., Washington, DC; CDL:050006-G)
00117329 Shell Chemical Co. (1969) CGardona: Residues in Milk and Other Subjects | . (Compilation;
unpublished study received on unknown date under 9F0805; CDL:093114-C)
00117339 Shell Chemical Co. (1969) Residue Data Developed from the Use of Rabon on Livestock.
(Compilation; unpublished study received Dec 13, 1970 under 1F1121; CDL:093431-C)
00117340 Shell Chemical Co. (1969) Residue Data for Rabon Metabolites in Chicken Tissues and Eggs from
California. (Compilation; unpublished study received Dec 1, 1969 under 9F0835; CDL:093538-A)
00117351 Shell Chemical Co. (1971) Analytical Methods for the Determination of the Pesticide Chemical:
CGardona | . (Compilation; unpublished study received Aug 6, 1971 under 2F1187;
CDL:093510-C)
00117354
Shell Chemical Co. (1973) Residue Data: CSD-84471
Oct 17, 1973 under 201-359; CDL: 101173-A)
(Compilation; unpublished study received
96
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BIBLIOGRAPHY
MRID
CITATION
00117361 Shell Chemical Co. (1975) Rabon Oral Larvicide Self-fed Supplement: Label Application.
(Compilation; unpublished study received Jul 22, 1975 under 201-392; CDL:220992-A)
00117389 Shell Chemical Co. (1978) CRabon: Residues in Tissue, Milk, and Fat of Cattle | . (Compilation;
unpublished study received Mar 30, 1979 under 201-407; CDL:237924-A)
00117443 U.S. National Institutes of Health (1978) Bioassay of tetrachlorvinphos for possible carcinogenicity.
By National Cancer Institute, Div. of Cancer Cause and Prevention, Carcinogenesis Program,
Carcinogen Bioassay and Program Resources Branch. Bethesda, MD: USNIH. (NCI-CG-TR-33;
CAS No. 961-11-5; DHEW publication no. (NIH)78-833; published study; CDL:238926-A)
00118265 Shell Oil Co. (1975) Residue Data in Support of the Use of Rabon Insecticide Cattle Ear Tags.
(Compilation; unpublished study received Apr 12, 1979 under TN 79/1; CDL:238024-B)
00120147 Shell Chemical Co. (1967) CDetermination of Gardona Residues in Various Products |.
(Compilation; unpublished study received Jun 12, 1968 under 9F0739; CDL:091275-A)
00120200 Shell Chemical Co. (1968) The Residue Data Developed from Test Plots Including a Description
of the Analytical Methods Used: CGardona Insecticide |. (Compilation; unpublished study received
Apr 27, 1969 under 9F0804; CDL:091388-B)
00120205 Shell Chemical Co. (1968) The Results of Tests on the Amount of Residues Remaining, Including
a Description of the Analytical Methods Used: CRabon |. (Compilation; unpublished study
received Apr 26, 1969 under 9F0805; CDL:091389-A)
00120206 Shell Chemical Co. (1969) The Results of Tests on the Amount of Residues Remaining, Including
a Description of the Analytical Methods Used: CRabon |. (Compilation; unpublished study
received Apr 26, 1969 under 9F0805; CDL:091390-A)
00120224 Sherman, M. (1964) Acute, Subacute and Chronic Toxicology Data on Rabon Insecticide to
Chickens. (Unpublished study received Oct 4, 1969 under 9F0835; prepared by Univ. of Hawaii,
submitted by Shell Chemical Co., Washington, DC; CDL:091439-B)
00120225 Yadava, C. (1969) An Investigation of the Toxicology and Residues of Rabon in Poultry. Doctoral
dissertation, Univ. of Massachusetts. (Unpublished study received Oct 4, 1969 under 9F0835;
submitted by Shell Chemical Co., Washington, DC; CDL:091439-C)
00120227 Shell Chemical Co. (1969) The Results of the Amount of Residues Remaining, Including a
Description of the Analytical Method: CRabon | . (Compilation; unpublished study received Oct
4, 1969 under 9F0835; CDL:091439-G)
00120229 Shell Chemical Co. (1969) Rabon Insecticide on Poultry. (Unpublished study received Oct 5, 1969
under 9F0835; CDL:091440-B)
97
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BIBLIOGRAPHY
MRID
CITATION
00126039 Hazleton Laboratories America, Inc. (1980) 103-week Chronic Feeding Study in Mice: SD-8447
and Original SD-8447. Final rept. (Unpublished study received Jul 31, 1980 under unknown
admin, no.; submitted by Shell Chemical Co., Washington, DC; CDL: 242976-A; 242977)
00127831 Laveglia, J.; Killeen, J.; Ignatoski, J. (1982) A Teratology Study in Rabbits with DS-36779:
Document No. 572-5TX-82-0007-003. (Unpublished study received Apr 13, 1983 under unknown
admin, no.; submitted by Diamond Shamrock Agricultural Chemicals, Cleveland, OH;
CDL:249988-A)
00130705 Ralston Purina Co. (1969) Residue Data Developed from the Use of Dairy Cattle. (Compilation;
unpublished study received Jun 17, 1983 under 602-301; CDL:251028-A)
00133913 Shell Chemical Co. (1973) Summary-Residues: CToxicity of SD 8447 in Cattle and Other
Mammals |. (Compilation; unpublished study received Dec 20, 1974 under 4H5047;
CDL:223244-B)
00138933 Coate, W.; Zoetis, T.; Hardy, R. (1983) Acute Inhalation Toxicity Study in Rats: Ralston Purina
Residual Livestock Insecticide: Project No. 2200-105. Final rept. (Unpublished study received
Jan 31, 1984 under 602-301; prepared by Hazleton Laboratories America, Inc., submitted by
Ralston Purina Co., St. Louis, MO; CDL:252343-C)
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.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide residues to four kinds of bees.
Environmental Entomology l(3):393-394.
05004211 Bowman, M.C.; Beroza, M. (1967) Temperature-programmed gas chromatography of 20
phosphorus-containing insecticides on 4 different columns and its application to the analysis of milk
and corn silage. Journal of the Association of Official Analytical Chemists 50(6): 1228-1236.
05006630 Oehler, D.D.; Eschle, J.L.; Miller, J.A.; Claborn, H.V.; Ivey, M.C. (1969) Residues in milk
resulting from ultra-low-volume sprays of malathion, methoxychlor, coumaphos, ronnel, or
Gardona for control of the horn fly. Journal of Economic Entomology 62(6): 1481-1483.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Intepretation and Data Base 410
Chemicals and 66 Species of Fresh-Water Animals. US Fish & Wildlife Service; Resource
Publication (160): 579 p.
40152701 Ford, W.; Killeen, J. (1987) A Teratology Study in Rats with Technical Rabon: Project ID:
1019-003; 85-0074. Unpublished study prepared by Ricerca, Inc. in cooperation with Argus
Research Laboratories, Inc. and Test Substance Analysic Laboratory. 298 p.
98
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BIBLIOGRAPHY
MRID
CITATION
40228401 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Intepretation and Data Base 410
Chemicals and 66 Species of Fresh-Water Animals. US Fish & Wildlife Service; Resource
Publication (160): 579 p.
40491301 Sheeran, P. (1987) Rabon Product Chemistry: Du Pont Report #84477 PC-1. Unpublished
compilation prepared by E.I. du Pont de Nemours & Co. 68 p.
40924701 Keeler, D. (1988) Determination of 2,3,7,8-Tertrachloro-p-dibenzodioxin and
2,3,7,8-Tetrachlorodibenzofuran in Technical Tetrachlorvinphos: Laboratory Project ID: Y2033.A.
Unpublished study prepared by Triangle Laboratories, Inc. 177 p.
41222501 Silveira, E. (1989) Technical Rabon Insecticide: Product Identity and Composition: Project ID
Y2033.C. Unpublished study prepared Du Pont de Nemours and Co. 97 p.
41222502 Silveira, E. (1989) Technical Rabon Insecticide: Analysis and Certification of Product Ingredients:
Project ID Y2033.D. Unpublished study prepared by Du Pont de Nemours and Co. 40 p.
41222503 Silveira, E. (1989) Technical Rabon Insecticide: Physical and Chemical Characteristics: Project
ID Y2033.B. Unpublished study prepared by Du Pont de Nemours and Co. 65 p.
41222504 Naas, D. (1989) Acute Oral Toxicity (LD50) Study in Albino Rats with Rabon Technical: Project
ID WIL-149001. Unpublished study prepared by WIL Research Laboratories, Inc. 69 p.
41222505 Naas, D. (1989) Acute Dermal Toxicity (LD50) Study in Albino Rabbits with Rabon Technical:
Project ID WIL-149002. Unpublished study prepared by WIL Research Laboratories, Inc. 25 p.
41222506 Naas, D. (1989) Primary Eye Irritation Study in Albino Rabbits with Rabon Technical: Project ID
WIL-149004. Unpublished study prepared by WIL Research Laboratories, Inc. 24 p.
41222507 Naas, D. (1989) Primary Dermal Irritation Study in Albino Rabbits with Rabon Technical: Project
ID WIL-149003. Unpublished study prepared by WIL Research Laboratories, Inc. 21 p.
41222508 Lawlor, T.; Valentine, D. (1989) Mutagenicity Test On Tetrachlorvinphos (TCVP); Rabon in the
Ames Salmonella?microsome Reverse Mutation Assay: HLA Study No. 10913-0-401R.
Unpublished study prepared by Hazleton Laboratories America, Inc. 35 p.
41257101 Forbis, A. (1989) Acute Toxicity of Rabon to Daphnia magna: Final Report No. 38116.
Unpublished study prepared by Analytical BioChemistry Laboratories, Inc. 176 p.
41312901 Murli, H. (1989) Mutagenicity Test on Tetrachlorvinphos (TCVP) in an in vitro Cytogenetic Assay
Measuring Chromosomal Aberration Frequencies in Chinese Hamster Ovary (CHO) Cells: Lab
Project Number: 10913/0/437. Unpublished study prepared by Hazleton Laboratories America,
Inc. 31 p.
99
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BIBLIOGRAPHY
MRID
CITATION
41342001 Naas, D. (1989) 21-Day Dermal Study in Rats with Rabon Technical: Final Report: Lab Project
Number WIL-149007. Unpublished study prepared by WIL Research Laboratories, Inc. 277 p.
41377902 Naas, D. (1989) Skin Sensitization Study in Albino Guinea Pigs with Rabon Technical: Lab Project
Number: WIL-149005. Unpublished study prepared by Wil Research Laboratories, Inc. 48 p.
41681301 Blumhorst, M. (1990) Adsorption/Desorption Studies-Batch Equilibrum for Rabon: Lab Project
Number: 149-001. Unpublished study prepared by EPL Bio-Analytical Services, Inc. 119 p.
41810101 Sharp, M. (1990) Domestic Animal Safety: Cholinesterase Test-Cats: Lab Project Number: 1077.
Unpublished study prepared by Sharp Veterinary Research. 20 p.
41810102 Sharp, M. (1990) Domestic Animal Safety: Cholinesterase Test-Dogs: Lab Project Number: 1073.
Unpublished study prepared by Sharp Veterinary Research. 19 p.
41905901 Naas, D. (1990) Acute Delayed Neurotoxicity Study in Hens with Rabon Technical: Lab Project
Number: WIL-149006. Unpublished study prepared by WIL Research Laboratories, Inc. 250 p.
41929101 Blumhorst, M. (1991) Aqueous Hydrolysis of Rabon: Lab Project Number: 149-003. Unpublished
study prepared by EPL Bio-Analytical Services, Inc. 88 p.
41988401 Hawkin, D.; Mayo, B.; Pollard, A.; et al. (1991) Rat Metabolism of Orally Administered: Ccarbon
14|Tetrachlorvinphos: Lab Project Number: 207-901645. Unpublished study prepared by
Huntingdon Research Centre Ltd. 76 p.
42013001 Silveira, E. (1991) Technical Rabon Insecticide: Product Identity and Composition: Lab Project
Number: Y2033.C. Unpublished study prepared by E. I. du Pont de Nemours and Co. 20 p.
42013002 Silveira, E. (1991) Technical Rabon Insecticide: Analysis and Certification of Product Ingredients:
Lab Project Number: Y2033.D. Unpublished study prepared by E.I. du Pont de Nemours and Co.
10 p.
42013003 Silveira, E. (1991) Technical Rabon Insecticide: Physical and Chemical Properties: Lab Project
Number: Y2033.B. Unpublished study prepared by E.I. du Pont de Nemours and Co. lip.
42054301 Barton, S. (1991) Tetrachlorvinphos: Two Generation Reproduction Study in Rats: Lab Project
Number: 438712. Unpublished study prepared by Inveresk Research International. 229 p.
42082401 Blumhorst, M. (1991) Aerobic Soil Metabolism Study of Rabon: Lab Project Number: 149-002.
Unpublished study prepared by EPL BioAnalytical Services, Inc. 190 p.
42111501 Hawkins, D.; Mayo, B.; Pollard, A.; et al. (1991) The Dermal Absorption of Carbon
14-Tetrachlorvinphos in the Rat: Lab Project Number: 208/91102. Unpublished study prepared
by Huntingdon Research Centre Ltd. 85 p.
100
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BIBLIOGRAPHY
MRID
CITATION
42156401 McKeon, M. (1992) Mutagenicity Test on Tetrachlorvinphos in the Rat Primary Hepatocyte
Unscheduled DNA Synthesis Assay: Final Report: Lab Project Number: 10913-1-447.
Unpublished study prepared by Hazleton Washington, Inc. 28 p.
42275201 Silveira, E. (1992) Technical Rabon Insecticide: Analysis and Certification of Product Ingredients:
Lab Project Number: Y2033.D. Unpublished study prepared by E.I. du Pont de Nemours and
Co., Inc. 6 p.
42407801 Silveira, E. (1992) Technical Rabon Insecticide: Physical and Chemical Characteristics:
CSupplement No. 21 : Lab Project Number: Y2033. B. Unpublished study prepared by E. I. Du
Pont de Nemours & Co. 9 p.
42520101 Hoberman, A. (1992) A Teratology Study in Rats with T-142-4: An Amendment: Lab Project
Number: 1019-003. Unpublished study prepared by Argus Research Laboratories, Inc. 88 p.
42622301 Meikle, S.; Baugher, D. (1992) Monitoring Exposure of Mixer/Loaders and Applicators Treating
Agricultural Premises with Tetrachlorvinphos (Rabon 50WP Insecticide) in Handheld Wand-type
Sprayers: Lab Project Number: 31189: 562: 62-RAB/92099. Unpublished study prepared by Orius
Associates, Inc. and PTRL East, Inc. 207 p.
42679201 Silveira, E. (1993) Technical Rabon Insecticide Analysis and Certification of Product Ingredients:
Supplement No. 3: Lab Project Number: Y2033.D. Unpublished study prepared by E.I. du Pont
de Nemours and Co. 9 p.
42679401 Tompkins, E. (1993) One Year Oral (Capsule) Toxicity Study in Dogs with Rabon
(Tetrachlorvinphos): Final Report: Lab Project Number: WIL-149009. Unpublished study
prepared by WIL Research Labs., Inc. 1079 p.
42828801 Krautter, G. (1993) The Metabolism of (carbon 14)Tetrachlorvinphos in the Lactating Goat
Following Oral Administration for 3 Consecutive Days: Lab Project Number: 542: 1508.
Unpublished study prepared by PTRL East, Inc. 131 p.
42828802 Krautter, G. (1993) The Metabolism of (carbon 14)Tetrachlorvinphos in Laying Hens Following
Dermal Application: Lab Project Number: 540: 1532. Unpublished study prepared by PTRL East,
Inc. 166 p.
42828803 Krautter, G. (1993) The Metabolism of (carbon 14)Tetrachlorvinphos in the Lactating Goat
Following Dermal Application: Lab Project Number: 541: 1531. Unpublished study prepared by
PTRL East, Inc. 127 p.
42848501 Krautter, G. (1993) The Dissipation of (carbon 14)Tetrachlorvinphos and Its Metabolites in Manure
from a Beef Cow Following Oral Administration for 14 Consecutive Days: Lab Project Number:
710: 1520. Unpublished study prepared by PTRL East, Inc. 101 p.
101
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42912501 Lamb, I. (1993) An Acute Neurotoxicity Study of Rabon in Rats: Lab Project Number:
WIL-149018. Unpublished study prepared by Wil Research Labs., Inc. 1050 p.
42980901 Mulhern, M.; Robb, D.; Perry, C.; et al. (1993) Tetrachlorvinphos: 104 Week Dietary Combined
Chronic Toxicity/Carcinogenicity Study in Rats: Lab Project Number: 7929. Unpublished study
prepared by Inveresk Research International. 1135 p.
42981001 Morris, T. (1993) Delayed Contact Hypersensitivity Study in Guinea Pigs with Technical RABON
Insecticide (Buehler Technique): Lab Project Number: 93-8055-21 (A): 93-8055-21. Unpublished
study prepared by Hill Top Biolabs, Inc. 86 p.
43160601 McKeown, K. (1994) Analysis of Gardona Samples from an Alternate Manufacturing Source:
Rabon: Lab Project Number: 1362/56: TM#0124-02. Unpublished study prepared by The Hartz
Mountain Corp. 32 p.
43160602 McKeown, K. (1994) Du Pont Analysis of Alternate Source Rabon Samples: Lab Project Number:
9859: 9878. Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc., Mobile
Manufacturing Center. 9 p.
43371201 Perry, C.; Mulhern, M.; Henderson, W. et al. (1990) Tetrachlorvinphos: 13 Week Dietary
Toxicity Study in Rats: Lab Project Number: 7258: IRI/438141. Unpublished study prepared by
Inveresk Research International. 194 p.
102
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\
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain product specific data as noted herein to the U.S. Environmental
Protection Agency (EPA, the Agency). These data are necessary to maintain the continued
registration of your product(s) containing this active ingredient. Within 90 days after you
receive this Notice you must respond as set forth in Section III below. Your response must
state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
103
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The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
104
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines 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 (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the requirements
of all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
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specific data requirements of this Notice is contained in Section III-C. A discussion of options
relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form, and the Requirements Status and Registrant's Response Form,
Attachment 2 and Attachment 3. The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and Registrant's
Response Form must be submitted for each product listed on the Data Call-in Response Form
unless the voluntary cancellation option is selected or unless the product is identical to another
(refer to the instructions for completing the Data Call-in Response Form in Attachment 2).
Please note that the company's authorized representative is required to sign the first page of the
Data Call-in Response Form and Requirements Status and Registrant's Response Form (if this
form is required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have questions or
need assistance in preparing your response, call or write the contact person(s) identified in
Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of
this Notice. If you wish to voluntarily cancel your product, you must submit a completed Data
Call-in Response Form, indicating your election of this option. Voluntary cancellation is item
number 5 on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under item
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number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide registrants to additional instructions provided in this Section. The
options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
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must be noted in the agreement to cost share by the registrant selecting this option. If you
choose to enter into an agreement to share in the cost of producing the required data but will not
be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
Notice by submitting a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is 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 do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this
Notice. Do not use this option if you are submitting data to upgrade a study. (See Option 5).
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You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact transcript may
be substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(k), means "any
material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
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If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
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III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is inappropriate,
you must attach a complete justification for the request, including technical reasons, data and
references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data
must be submitted in the format required by PR Notice 86-5). This will be the only opportunity
to state the reasons or provide information in support of your request. If the Agency approves
your waiver request, you will not be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. If the Agency denies your waiver request, you must choose an option for meeting the
data requirements of this Notice within 30 days of the receipt of the Agency's decision. You
must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver
only under extraordinary circumstances. You should also be aware that submitting a waiver
request will not automatically extend the due date for the study in question. Waiver requests
submitted without adequate supporting rationale will be denied and the original due date will
remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
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6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in
the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-in Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. 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 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain 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, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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TETRACHLORVINPHOS DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Tetrachlorvinphos.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Tetrachlorvinphos. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) a list of registrants
receiving this DCI (Attachment 5) and (6) the Cost Share and Data Compensation Forms in
replying to this Tetrachlorvinphos Product Specific Data Call-In (Attachment (6)). Instructions
and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Tetrachlorvinphos
are contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on Tetrachlorvinphos are needed for specific products. These
data are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregistration of all eligible Tetrachlorvinphos products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Jeffrey Billingslea at (703) 308-8004.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Jeffrey Billingslea
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Tetrachlorvinphos
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data exemption,
you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide
the EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such
products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
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DATA CALL-IN RESPONSE Page 1 of 1
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
Item 3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless
EPA determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In
Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all
the requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-In Notice. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Notice that my product
119
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is similar enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the required
data; if the required study is not submitted on time, my product may be subject
to suspension. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an attachment to this Data Call-in
Notice that my product is similar enough to another product to qualify for this
option. I am submitting evidence that I have made an offer to another
registrant (who has an obligation to submit data) to share in the cost of that
data. I am also submitting a completed "Certification of Offer to Cost Share
in the Development Data" form. I am including a copy of my offer and proof
of the other registrant's receipt of that offer. I am identifying the party which is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. I understand that
other terms under Option 3 in the Data Call-In Notice (Section III-C.l.) apply
as well. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing
Study). I certify that this study will meet all the requirements for submittal of
existing data outlined in Option 4 in the Data Call-In Notice (Section III-C.l.)
and will meet the attached acceptance criteria (for acute toxicity and product
chemistry data). I will attach the needed supporting information along with this
response. I also certify that I have determined that this study will fill the data
requirement for which I have indicated this choice. By the specified due date, I
will also submit a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) to show what data
compensation option I have chosen. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID
or Accession number of the study at the due date. I understand that the
conditions for this option outlined Option 5 in the Data Call-In Notice (Section
120
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III-C.l.) apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute
toxicity or certain efficacy data and only if the cited study was conducted on my
product, an identical product or a product which EPA has "grouped" with one
or more other products for purposes of depending on the same data. I may also
choose this option if I am citing my own data. In either case, I will provide the
MRID or Accession number(s) for the cited data on a "Product Specific Data
Report" form or in a similar format. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my
request. If the Agency approves my waiver request, I will not be required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies
my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30
days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option
chosen. I also understand that the deadline for submission of data as specified
by the original data call-in notice will not change. By the specified due date, I
will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
have already voluntarily canceled this product. For these cases, please supply
all relevant details so that EPA can ensure that its records are correct.
121
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122
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REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Page 1 of 2
123
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124
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REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Page 2 of 2
125
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126
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS Page 1 of 2
127
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS Page 2 of 2
128
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EPA'S BATCHING OF TETRACHLORVINPHOS PRODUCTS FOR MEETING
REREGISTRATION ACUTE TOXICITY DATA REQUIREMENTS
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing
TETRACHLORVINPHOS as the active ingredient, the Agency has batched products which
can be considered similar for purposes of acute toxicity. Factors considered in the sorting
process include each product's active and inert ingredients (identity, percent composition and
biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered chemically similar or have
identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrant's option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so. If
a registrant supplies the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant
depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should
129
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know that choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
One hundred thirty two products were found which contain TETRACHLORVINPHOS
as the active ingredient. The products have been placed into twelve batches and a "no batch"
category in accordance with the active and inert ingredients, type of formulation and current
labeling. Table 1 identifies the products in each batch. Table 2 lists the products which has
been placed in the "no batch" category. The following summarizes acute data requirement by
batch:
Q Registrants with products in Batch 1 may cite acute data on the technical product.
Q Registrants with products in Batch 2 may cite acute data on the technical product with
the exception of the eye irritation study. Since the products in this batch may be more
irritating to the eyes, an eye irritation study performed on a product in this batch is
needed.
Q Registrants with products in Batch 3 need to cite/submit all acute data on one of the
subject products.
Q Registrants with products in Batch 4 may cite acute data on the technical product.
Q All products in Batch 5 are already supported by currently acceptable acute data. The
registrant of the products in this batch should reference the existing data to support
reregistration.
Q Registrants with products in Batch 6 may cite acute data on the technical product.
Q Registrants with products in Batch 7 may cite acute data on the technical product with
the exception of the eye irritation study. Since the products in this batch may be more
irritating to the eye, an eye irritation study performed on a product in this batch is
needed.
Q Registrants with products in Batch 8 may cite acute data on the technical product with
the exception of the eye irritation study. Since the products in this batch may be more
irritating to the eye, an eye irritation study performed on a product in this batch is
needed.
Q Registrants with products in Batch 9 may cite acute data on the technical product with
the exception of the eye irritation study. Since the products in this batch may be more
irritating to the eye, an eye irritation study performed on a product in this batch is
needed.
Q Registrants with products in Batch 10 may cite acute data on the technical product.
Q Registrants with products in Batch 11 may cite acute data on the technical product with
the exception of the eye irritation study. Since the products in this batch may be more
irritating to the eye, an eye irritation study performed on a product in this batch is
needed.
Q Registrants with products in Batch 12 need to cite/submit all acute data on one of the
subject products.
Since acute data generated with the technical material can be cited in most cases, a
complete set of new acutes is only needed for products in batch 3, batch 12 and the no batch
group. If a registrant does not believe that the results of the technical data apply to a
particular end use product or group of products within a batch, product/batch specific data
may be submitted.
130
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Table 1
Batch
i
2
3
4
5
6
EPA Reg. No.
2596-131
56493-34
56493-38
56493-88
62725-1
70-191
28293-76
34704-432
47000-68
56493-13
56493-45
56493-42
56493-43
2596-49
2596-50
2596-62
2596-63
2596-83
2596-84
56493-50
56493-89
56493-90
2596-122
2596-123
2596-125
2596-126
270-164
1352-62
6482-8
11715-202
11715-203
11715-217
40833-5
65901-1
Percent Tetrachlorvinphos
99.0
97.3
97.3
98.7
98.8
50.0
50.0
50.0
50.0
50.0
50.0
23.0
Dichlorvos 5.3
23.0
Dichlorvos 5.3
13.7
13.7
13.7
13.7
14.55
14.55
13.7
13.7
13.7
0.96
0.96
1.07
1.07
2.46
0.40
0.15
0.47
0.30
2.96
0.30
0.47
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Spray
Spray
Collar
Collar
Collar
Collar
Collar
Collar
Tag
Collar
Collar
Spray
Spray
Spray
Spray
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
131
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Batch
7
8
EPA Reg. No.
70-192
70-224
299-188
572-295
2393-393
2596-78
2596-79
11715-208
19713-340
28293-13
34704-266
34704-276
34704-307
47000-66
47000-67
56493-28
56493-44
58210-3
67517-40
99-118
534-94
602-267
602-268
602-311
602-359
602-360
1304-64
1304-66
1304-68
1352-26
1352-56
1352-60
1352-61
1352-63
1990-386
1990-387
1990-517
2011-5
2011-6
Percent Tetrachlorvinphos
3.0
1.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
1.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
0.84
0.40
1.45
1.45
1.23
0.57
0.77
0.98
0.98
0.68
1.72
0.50
0.30
1.2
0.61
1.0
0.46
1.0
1.0
1.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
132
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Batch
8
EPA Reg. No.
2011-7
4089-5
6552-12
6552-13
6552-14
6552-17
7138-12
7455-32
7627-21
7627-22
7627-26
7698-7
7702-5
9078-6
9078-12
9374-8
9374-9
11715-284
12714-3
20552-2
37774-9
38110-4
38110-7
40833-4
40833-6
40833-9
40833-10
40833-11
40833-12
40833-13
41200-2
43757-1
44666-1
46911-1
55392-1
Percent Tetrachlorvinphos
1.0
1.24
1.25
0.75
1.25
0.47
0.35
1.0
0.60
0.30
0.63
1.40
1.0
0.93
0.31
0.30
0.80
0.46
1.79
0.30
4.0
1.0
1.0
0.49
0.60
1.0
1.0
1.0
0.30
1.24
1.23
1.0
1.0
0.70
0.80
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
133
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Batch
9
10
11
12
EPA Reg. No.
1352-24
3213-36
4987-5
7455-23
38092-3
39258-11
39409-1
48390-1
56493-35
99-121
67517-26
1304-63
2011-10
37774-1
40833-8
56493-29
67517-33
Percent Tetrachlorvinphos
7.76
7.76
7.76
7.76
7.76
7.76
7.76
7.76
7.76
6.60
7.76
7.76
7.76
7.76
7.76
24.0
24.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Liquid
Liquid
The following table lists products that were either considered not to be similar or the
Agency lacked sufficient information for decision making and were not placed in any batch.
The registrants of these producs are responsible for meeting the acute toxicity data
requirements separately.
Table 2 (No Batch)
EPA Reg. No.
1352-59
2596-89
2596-119
56493-27
28293-28
28293-27
56493-19
% Tetrachlorovinphos
0.18
0.99
2.8
1.0
Dichlorvos 0.23
2.0
Pyrethrins 0.09
Piperonyl butoxide, tech 0.18
N-octyl bicycloheptene 0.30
1.0
Pyrethrins 0.09
Piperonyl butoxide, tech 0.18
N-octyl bicycloheptene 0.30
Di-n-propyl iso-
cinchomeronate 0.50
75.0
Formulation Type
Solid
Spray
Liquid
Liquid
Gel
Spray
Solid
134
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LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE Page 1 of 2
135
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LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE Page 1 of 2
136
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
all common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
137
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138
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3 31 96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Keg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Name and
of Company's Authorized Representative
Date
Title (Please Type or Print)
EPA Form 8570 32 (5/91) Replaces EPA Form 8580, which is obsolete
141
-------
142
-------
United States Environmental Protection Agency
Washington, DC 20460
.^os%
USEfcJ
CERTIFICATION WITH RESPECT TO V, ^
"**/ poO"\'C*
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or reregistration
under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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The following is a list of available documents for Tetrachlorvinphos that my further assist
you in responding to this Reregistration Eligibility Decision document. These documents may
be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Jeffrey Billingslea at (703)-308-8004.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Tetrachlorvinphos.
The following documents are part of the Administrative Record for Tetrachlorvinphos and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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