United States Prevention, Pesticides EPA738-R-96-001
Environmental Protection And Toxic Substances December 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Hydroxyethyl octyl sulfide
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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 hydroxyethyl octyl
sulfide which includes the active ingredient hydroxyethyl octyl sulfide-2-(octylthio) ethanol.
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.
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 is due 90 days from the
receipt of this letter. The second set of required responses is 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 Jean
Holmes (703) 308-8008. Address any questions on generic data to the Special Review and
Reregistration Division representative Ron Kendall at (703) 308-8068.
Sincerely yours,
Lois Rossi, Division 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, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; 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 time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. 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, but are not
required to, 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).
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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
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
2-Hydroxyethyl octyl sulfide
LISTC
CASE 3103
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
2-HYDROXYETHYL OCTYL SULFIDE REREGISTRATION ELIGIBILITY TEAM . . . i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 4
III. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 4
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 7
c. Developmental Toxicity 7
d. Mutagenicity 8
e. Other Toxicological Concerns 9
2. Exposure Assessment 9
a. Dietary Exposure 9
b. Residential and Occupational Exposure 9
3. Risk Assessment 10
a. Dietary 10
b. Occupational and Residential 10
C. Environmental Assessment 10
1. Ecological Toxicity Data 10
a. Toxicity to Terrestrial Animals 10
b. Toxicity to Aquatic Animals 12
c. Toxicity to Plants 12
2. Environmental Fate 13
a. Environmental Fate Assessment 13
b. Environmental Fate and Transport 13
3. Exposure and Risk Characterization 16
a. Exposure and Risk to Nontarget Terrestrial Animals .... 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 17
A. Determination of Eligibility 17
B. Determination of Eligibility Decision 18
1. Eligibility Decision 18
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2. Eligible and Ineligible Uses 18
C. Regulatory Position 18
1. Risk Mitigation Measures/Labeling Rationale 18
V. ACTIONS REQUIRED BY REGISTRANTS 20
A. Manufacturing-Use Products 20
1. Generic Data Requirements 20
2. Labeling Requirements for Manufacturing-Use Products 20
B. End-Use Products 21
1. Additional Product-Specific Data Requirements 21
2. Labeling Requirements for End-Use Products 21
a. PPE/Engineering Control Requirements for Pesticide Handlers
21
b. Application Restrictions 21
c. User Safety Requirements 22
d. User Safety Recommendations 22
e. Use Limitations 22
C. Existing Stocks 23
VI. APPENDICES 25
APPENDIX A. Table of Use Patterns Subject to Reregistration 26
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 35
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of hydroxyethyl octyl sulfide 40
APPENDIX D. Product Specific Data Call-in 47
Attachment 1. Chemical Status Sheets 59
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 60
Attachment 3. Product Specific Data Call-In Response Forms (Form B
inserts) Plus Instructions 62
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 69
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice 75
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 76
APPENDIX E. List of Available Related Documents 82
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2-HYDROXYETHYL OCTYL SULFIDE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
John Faulkner
Gabe Patrick
William Gross
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Karen Angulo
James Breithaupt
Renee Costello
Health Effects Risk Assessment
Tom Myers
Jess Rowland
Tom Campbell
Felicia Fort
Registration Support
Lucy Markarian
Shyam Mathur
Joe Travano
Risk Management
Ron Kendall
Kathleen Depukat
Office of Compliance:
Rick Colbert
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Risk Characterization and Analysis Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 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.
LD50 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 i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
PHI Preharvest Interval
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 © 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
The U.S. Environmental Protection Agency (referred to as "the Agency") has
completed its reregistration eligibility decision of 2-hydroxyethyl octyl sulfide hereafter referred
to as hydroxyethyl octyl sulfide. This decision includes a comprehensive reassessment of the
required target data and the use patterns of currently registered products. Hydroxyethyl octyl
sulfide is an insect repellent used in recreational areas, refuse/solid waste containers (garbage
cans), compost/compost piles, household/domestic dwellings, and pet living/sleeping quarters.
The Agency has concluded that all uses as prescribed in this document, will not cause
unreasonable risks to humans or the environment and therefore, all products are eligible for
reregistration.
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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 hydroxyethyl octyl sulfide. The document consists of six sections. Section
I is the introduction. Section II describes hydroxyethyl octyl sulfide, 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
hydroxyethyl octyl sulfide. Section V discusses the reregistration requirements for hydroxyethyl
octyl sulfide. 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 Reregi strati on Eligibility
Decision:
Common Name:
Chemical Name:
Trade Names:
Hydroxyethyl octyl sulfide
2-Hydroxyethyl octyl sulfide
2(Octylthio) ethanol
MGK R-874
CAS Registry Number: 3547-33-9
OPP Chemical Code: 46301
B.
Empirical Formula:
Molecular Weight:
Basic Manufacturer:
Use Profile
C10H22OS
190
McLaughlin Gormley King Co.
The following is information on the currently registered uses of hydroxyethyl octyl
sulfide with an overview of use sites and application methods. A detailed table of these
uses is in Appendix A.
TYPE OF PESTICIDE:
MODE OF ACTION:
USE SITES:
Insect repellent/feeding depressant
Repellent-moderately negative effect on insect nervous
system.
Terrestrial nonfood crop:
Recreational areas, refuse/solid waste containers
(garbage cans).
Outdoor residential:
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Ornamental and/or shade trees, compost/compost
piles, household/domestic dwellings outdoor
premises, refuse/solid waste containers (garbage
cans)
Indoor residential:
Household/domestic dwellings, household/domestic
dwellings indoor premises, pet living/sleeping
quarters.
Indoor Food:
Household/domestic dwellings indoor food handling
areas. The Agency considers this a non-food use for
hydroxyethyl octyl sulfide as long as the following
precautionary labeling requirements are included on
the labels:
"Do not use in commercial food processing, storage
preparation or serving areas. In the home, all food
processing surfaces and utensils should be covered
or removed during treatment and thoroughly washed
before use. Cover and remove food before
treatment."
PESTS:
FORMULATION TYPES:
Ants, ticks, centipedes, flying moths, roaches, crickets,
fleas, flies, gnats, mosquitoes, silverfish, waterbugs,
spiders, and wasps.
Emulsifiable concentrate~5-9.1% and up to four other AIs
Pressurized liquid—0.1-1.5% and up to four other AIs
Formulation not identified—10-100% and up to four other
AIs
Formulation not identified/liquid—25% and two other AIs
METHODS AND RATES
OF APPLICATION: Pressurized liquid—Apply spot, contact, surface, and fog
treatments by spraying with aerosol can.
Emulsifiable concentrate—Apply with automatic or ordinary
sprayer at 0.25 gal product/gal spray.
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EQUIPMENT:
Aerosol can and Ready-to-Use Fogger.
TIMING:
USE LIMITATIONS:
Evening to late evening, nighttime, or as needed.
The following limitations apply for outdoor uses. Keep out
of lakes streams and ponds. Do not apply directly to water
or wetlands, swamps, bogs, marshes and potholes. Spray
from center when not breezy. Spray with wind if breeze is
blowing.
C. Regulatory History
Hydroxyethyl octyl sulfide was first registered in the United States in 1962 for use
as an insect repellent. There are currently 26 pesticide products registered primarily for
homeowner use which contain hydroxyethyl octyl sulfide as an active ingredient. In
September 1992, EPA issued a Data Call-in under reregistration Phase 4 requiring the
registrant to provide appropriate chemistry, toxicology and environmental fate data on this
active ingredient. This Reregistration Eligibility Decision reflects a reassessment of all
data which were submitted in response to the Data Call-in.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: Clear, colorless to faint yellow
Physical State: Semi-viscous liquid at 25°C
Odor: Mild sweet odor
Boiling Point:
Density:
Solubility:
Vapor Pressure:
Octanol/Water
Partition Coefficient:
Stability:
288°C at 760 mm Hg
0.935 g/mL at 20°C
Soluble in most organic solvents such as acetone, methanol,
isopropanol, and petroleum ether. Also soluble in water at
0.0968 g/L
5.94x 104Torrat25°C
Kowis4,367at25°C
Stable under normal storage conditions
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B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on hydroxyethyl octyl sulfide, as a non-food use
pesticide, is adequate and will support a reregistration decision.
a. Acute Toxicity
Results of the acute toxicity studies conducted with technical grade
hydroxyethyl octyl sulfide (96.1%) are summarized below in Table 1:
Table 1 . Acute Toxicity Values of hydroxyethyl octyl sulfide
Route
Oral
Dermal
Inhalation
Eye Irritation*
Skin Irritation*
Dermal Sensitization*
Species
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD5n = > 5000 mg/kg
LD5n = > 2000 mg/kg
LC50 = >6.12 mg/L
Moderate irritant
Slight irritant
Non-sensitizer
Toxicity
Category
IV
III
IV
II
III
NA
* This study is a requirement for manufacturing-use and end-use products (40 CFR 158). The
hydroxyethyl octyl sulfide data have been generated on the TGAI and are presented here for
informational purposes.
In an acute oral toxicity study, a group of young adult Sprague-
Dawley rats (5/sex) was administered a single oral dose of undiluted
technical hydroxyethyl octyl sulfide (96.1%) at 5000 mg/kg (Limit Dose).
One female was found dead on Day 2. Clinical signs observed in both sexes
were ruffled fur, diarrhea, dark stained muzzle, and anogenital staining. By
Day 6, all rats recovered from the above conditions and appeared active
and healthy for the remainder of the 14 day observation period. No
treatment-related gross pathology was observed at termination. The acute
oral LD50 was greater than 5000 mg/kg for both sexes. This suggests
hydroxyethyl octyl sulfide is practically non-toxic via the oral route in rats
and places it in Toxicity Category IV for acute oral toxicity (MRID
41772801).
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In an acute dermal toxicity study, technical hydroxyethyl octyl
sulfide (96.1%) was applied to the intact skin of New Zealand white rabbits
(5/sex) at 2000 mg/kg (Limit Dose) for a period of 24 hours. The test
material produced well defined erythema with severe edema and eschar at
4 days. Body weight loss was seen in 4/5 males and 4/5 females on Day
7, and in 2/5 males and 4/5 females on Day 14. Decreases in body weight
gain were seen in 2/5 males and 4/5 females during the 14 day period.
While no clinical signs were seen in males, 1-4 females exhibited tremors,
lethargy, signs of diarrhea, no feces or thin appearance on Days 6 through
14. Gross necropsy revealed a lower gastrointestinal tract full of gas,
mucus and dark liquid in two males and three females. The results of this
study determined that the acute dermal LD50 was greater than 2000 mg/kg
for both sexes. This suggests that hydroxyethyl octyl sulfide is slightly
toxic via the dermal route in rabbits and places it in Toxicity Category III
for acute dermal toxicity (MRID 41772802).
In an acute inhalation toxicity study, groups of Sprague-Dawley rats
(5/sex) were exposed to aerosol concentrations of undiluted technical
hydroxyethyl octyl sulfide (96.1%) at a mean analytical concentration of
6.12 ± 0.16 mg/L (slightly excessive of the Limit-Dose) with a mass
median aerodynamic diameter (MMAD) particle size distribution of 2.0 ±
0.03 jjM for 4-hours. The results of this study determined that the acute
inhalation LC50 was greater than 6.12 mg/L (above the Limit-Dose) for
both sexes. This suggests that hydroxyethyl octyl sulfide is practically non-
toxic via the inhalation route in rats and places it in Toxicity Category IV
for acute inhalation toxicity (MRID 41772803).
In a primary eye irritation study, 0.1 mL of technical hydroxyethyl
octyl sulfide (96.1%) was instilled into the conjunctival sac of New Zealand
white rabbits (3/sex). Hydroxyethyl octyl sulfide produced mucus
discharge in one, hazy cornea in four, and conjunctival irritation in all
rabbits. Although no visible corneal opacity or iritis was noted, the positive
reading noted in five rabbits during fluorescein dye examination indicated
damage to the corneal epithelium. No ocular effects were seen by Day 14.
Since conjunctival irritation was seen in all animals and fluorescein
readings did indicate damage to corneal epithelium which was not visible
to the naked eye, the test material is considered to be a moderate eye
irritant. The results of this study determined that hydroxyethyl octyl sulfide
is a moderate eye irritant in rabbits, places it in Toxicity Category II for
eye irritation (MRID 41772804).
In a primary dermal irritation study, New Zealand white rabbits
(3/sex) received 0.5 mL of technical hydroxyethyl octyl sulfide (96.1%) on
the intact skin under 4-hour semi-occluded conditions. Treatment-related
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dermal reactions were erythema, edema and eschar formation; the average
of the 4-, 24-, 48-, and 72-hour scores was 3.63. The results of this study
determined that hydroxyethyl octyl sulfide was a slight irritant, places it in
Toxicity Category III for dermal irritation (MRID 41772805).
In a study to evaluate the dermal sensitization potential of technical
hydroxyethyl octyl sulfide (96.1%), 12 Hartley guinea pigs received dermal
applications of 0.5 mL of the test material as a 1% v/v mixture in white
mineral oil to the pre-assigned, delineated test site 3 times/week during a
3-week induction phase (total of 9 applications). Following a two-week
resting period, the animals were challenged at the same concentration.
None of the treated or naive control animals exhibited any irritation when
challenged; the average skin reaction score for the virgin site was 0.0. A
non-irritating dose (0.5 mL) of the positive control (0.1% 2-DNCB in 50%
ethanol: saline solution) produced sensitization response (erythema and
edema). Under the conditions of this study, hydroxyethyl octyl sulfide was
shown to be a non-sensitizer in guinea pigs (MRID 41772806).
b. Subchronic Toxicity
In a 21-day dermal toxicity study, New Zealand white rabbits
(5/sex/dose) were given repeated dermal applications of technical
hydroxyethyl octyl sulfide (100%) in corn oil at doses of 50, 100 or 200
mg/kg, 6 hours/day, 7 days/week for 21 days; the vehicle control group
(5/sex) received corn oil only on the same regimen. Treatment had no
adverse effect on survival, clinical signs, mean body weights, body weight
gain, food consumption, hematology, clinical chemistry, organ weights or
gross histopathology. Treatment-related skin reactions were confined
mainly to a proportion of animals receiving 100 or 200 mg/kg/day. Dermal
reactions included: skin wrinkling in 1 male at 200 mg/kg/day;
desquamation in 1 female at the vehicle control, 1 male and 1 female at 50
mg/kg/day, in 3 males and 2 females at 100 mg/kg/day, and in 5 males and
4 females at 200 mg/kg/day; and moderate to severe erythema usually in
combination with moderate edema in 1 male and 1 female at the vehicle
control and at 50 mg/kg/day, in 4 males and 0 females at 100 mg/kg/day
and in 4 males and 2 females at 200 mg/kg/day. Based on these results,
for dermal irritation the NOEL was 50 mg/kg/day and the LOEL was 100
mg/kg/day. For systemic toxicity the NOEL was > 200 mg/kg/day
(HOT); a LOEL was not established (MRID 43123301).
c. Developmental Toxicity
In a developmental toxicity study, Sprague-Dawley Crl:CD BR rats
(24/group) were orally administered technical hydroxyethyl octyl sulfide
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(96.5%) at 0, 100, 300 or 1000 mg/kg/day (Limit-Dose) during Days 6
through 15 of gestation. No maternal toxicity was seen. The slight decrease
in food consumption seen during gestation Days 9-11 in dams treated at
1000 mg/kg/day was not considered to be toxicologically significant due to
the size of the standard deviations, range of food consumed, and because
there were no corresponding decreases in either mean body weight or
weight gain. Treatment had no effect on any of the cesarean parameters.
Therefore, for maternal toxicity the NOEL was 1000 mg/kg/day (HOT);
a LOEL was not established. No treatment-related fetal external or fetal
soft tissue abnormalities were seen at any dose level. Treatment-related
skeletal variations were limited to an increase, both in the number and
percent of fetuses, as well as litters with 14th vestigial ribs at 1000
mg/kg/day when compared to controls. No treatment-related skeletal
malformations were seen. Based on these results, the NOEL for
developmental toxicity was 300 mg/kg/day and the LOEL was 1000
mg/kg/day. The LOEL was based on increased incidence of skeletal
variations (MRID 42225802).
d. Mutagenicity
In a Salmonella/Mammalian microsome reverse mutation assay,
when tested at concentrations of 0, 3, 10, 33 or 333 jig/plate in
S.typhimurium strains TA98, TA100, TA1535 and TA1538, technical
hydroxyethyl octyl sulfide (96.9%) was non-mutagenic in both the presence
and absence of rat liver activation (MRID 41784003).
In a forward gene mutation assay, technical hydroxyethyl octyl
sulfide (96.9%) gave negative results following exposure of Chinese
hamster ovary cells at 0, 0.013, 0.025 or 0.05 jig/mL in the presence of
metabolic activation and at concentrations of 0, 0.007, 0.013, 0.025 or
0.05 jig/mL in the absence of metabolic activation (MRID 41784002).
When tested in the L5178Y TK +/- mouse lymphoma assay,
technical hydroxyethyl octyl sulfide (96.9%) was non-mutagenic both with
(at concentrations ranging from 0.42 to 0.94 jiL/mL) and without (at
concentrations ranging from 0.01 to 0.05 jiL/mL) metabolic activation
(MRID 41784001).
In an in vitro primary rat hepatocyte UDS assay, technical
hydroxyethyl octyl sulfide (96.9%) at concentrations of 0, 0.001, 0.003,
0.01, 0.03, 0.05, 0.075, or 0.1 jiL/mL, did not cause a significant increase
in the net nuclear grain counts of treated hepatocytes (MRID 41802101).
e. Other Toxicological Concerns
-------
The Agency waived the requirement for a 90-Day inhalation study
in rats with hydroxyethyl octyl sulfide because of its low acute inhalation
toxicity and the lack of systemic toxicity in both the 21-day dermal study
and the developmental toxicity study.
Based upon the Agency's review of the toxicology database for
hydroxyethyl octyl sulfide, no short-term (1-7 days) or intermediate-term
(7-90 days) occupational or residential exposure toxicological endpoints of
concern were identified.
2. Exposure Assessment
a. Dietary Exposure
Based on the current use patterns and exposure profiles for
hydroxyethyl octyl sulfide, residues in/on food and/or feed are not expected
to occur. Because there is no expected dietary exposure to hydroxyethyl
octyl sulfide, a dietary exposure assessment is not required.
b. Residential and Occupational Exposure
A residential and/or occupational exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators)
during use or to persons entering treated sites after application is complete.
While products containing hydroxyethyl octyl sulfide are primarily
for homeowner use, the Agency assumes there may be a potential for
exposure to hydroxyethyl octyl sulfide in both residential and occupational
settings under the current use-patterns associated with hydroxyethyl octyl
sulfide products. The Agency identified the following two potential
exposure scenarios:
• primary handler exposure — persons handling end-use
pesticide products containing hydroxyethyl octyl sulfide as
an active ingredient;
• primary post-application exposures — persons in and near
areas where end-use pesticide products containing
hydroxyethyl octyl sulfide as an active ingredient are being
or have recently been applied.
3. Risk Assessment
-------
a. Dietary
Based on the current use patterns and exposure profiles for
hydroxyethyl octyl sulfide, residues in/on food and/or feed are not expected
to occur. Therefore, a dietary risk assessment is not required.
b. Occupational and Residential
The Agency determined that the potential handler and post
application exposure scenarios to hydroxyethyl octyl sulfide do not warrant
a quantitative risk assessment because no toxicological endpoints of concern
were identified in Section III. However, the Agency has determined that it
is prudent to require consistent use precautions to afford product users
increased protection from unnecessary exposure either during application
or immediately following applications.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to assess the hazard of hydroxyethyl octyl
sulfide to nontarget terrestrial organisms.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the acute and subacute toxicity of
hydroxyethyl octyl sulfide 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); and two subacute dietary studies (LC50) on one
species of waterfowl (preferably the mallard duck) and one
species of upland game bird (preferably bobwhite quail).
10
-------
TABLE 2: Avian Acute Oral Toxicity Findings.
Species
Northern Bobwhite
Mallard
% A.I.
100
100
LD5(1 mg/kg
> 2,250
> 2,250
Toxicity Category
Practically nontoxic
Practically nontoxic
TABLE 3: Avian Subacute Dietary Toxicity Findings.
Species
Northern Bobwhite
Mallard
% A.I.
100
100
LC5(1 ppm
> 6,554
> 6,554
Toxicity Category
Practically nontoxic
Practically nontoxic
These results indicate that hydroxyethyl octyl sulfide is
practically nontoxic to avian species on an acute oral (TABLE 2)
and subacute dietary basis (TABLE 3). The guideline
requirements are fulfilled. (MRIDs 41983001, 41983002,
41948001, and 41948002)
(2)
Insects
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. Based on the use
pattern, which includes outdoor terrestrial uses, honey bee
exposure to hydroxyethyl octyl sulfide is expected and therefore,
acute testing is required.
TABLE 4: Nontarget Insect Toxicity Findings.
Species
Honey Bee
%AI
96.3
LD50 fig/bee
56.9
Toxicity Category
Practically nontoxic
There is sufficient information to characterize
hydroxyethyl octyl sulfide as practically nontoxic to bees
(TABLE 4). The guideline requirement is fulfilled. (MRID
41982901)
11
-------
Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of hydroxyethyl octyl
sulfide 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 cold water species
(preferably the rainbow trout), and the other should use a warm
water species (preferably the bluegill sunfish).
TABLE 5: Freshwater Fish Acute Toxicity Findings.
Species
Rainbow trout
Bluegill sunfish
% A.I.
96.5
96.5
LC5(1 ppm
2.9
2.8
Toxicity Category
Moderately toxic
Moderately toxic
The results of the acute toxicity studies indicate that
hydroxyethyl octyl sulfide is moderately toxic to both cold and
warm water fish (TABLE 5). The guideline requirements are
fulfilled. (MRID 41910202 and 41910203)
(2)
Freshwater Invertebrates
The minimum testing required to assess the hazard of
hydroxyethyl octyl sulfide to freshwater invertebrates is a
freshwater aquatic invertebrate toxicity test, preferably using first
instar Daphnia magna or early instar amphipods, stoneflies,
mayflies, or midges.
TABLE 6: Freshwater Invertebrate Toxicity Findings.
Species
Daphnia magna
% A.I.
96.5
EC5(1 ppm
0.37
Toxicity Category
Highly toxic
There is sufficient information to characterize
hydroxyethyl octyl sulfide as highly toxic to aquatic invertebrates
(TABLES). The guideline requirement is fulfilled. (MRID
41910204)
Toxicity to Plants.
12
-------
Terrestrial and aquatic plant testing (seedling emergence and
vegetative vigor) was not required for hydroxyethyl octyl sulfide.
2. Environmental Fate
a. Environmental Fate Assessment
All environmental fate data requirements are now satisfied for the
outdoor, residential, terrestrial and non-food uses of hydroxyethyl octyl
sulfide. Leaching and runoff are not likely to be significant based on the
use patterns and lack of persistence in aerobic soil of both the parent
compound and metabolites (T1/2 < 2 days), and the moderate mobility in
soils with low organic material. Hydroxyethyl octyl sulfide is not
expected to undergo direct photolysis, therefore, the Agency waived the
aqueous photolysis data requirement. The Agency also waived the aged
leaching-adsorption-desorption and terrestrial field dissipation data
requirements for all uses because the parent compound and its
metabolites degrade very rapidly in aerobic soil. Should hydroxyethyl
octyl sulfide be applied using foggers in areas that are adjacent to
surface waters, there would be some potential for surface water
contamination due to drift.
b. Environmental Fate and Transport
The submitted studies are acceptable and give a consistent
understanding of hydroxyethyl octyl sulfide dissipation in the
environment. Hydroxyethyl octyl sulfide and its sulfoxide and sulfone
degradates are not likely to persist for any significant amount of time,
having half-lives of < 2 days in soil. Even though hydroxyethyl octyl
sulfide residues are moderately mobile in soil and have a relatively high
water solubility (97 ppm), ground and surface water contamination are
not likely based on the lack of persistence in soil, the limited amount of
use, and its outdoor application as a fog. However, hydroxyethyl octyl
sulfide may persist if it is applied directly to water.
(1) Hydrolysis.
Hydroxyethyl octyl sulfide is an aliphatic compound that
is stable to hydrolysis at pH 5, 7, and 9.(MRID 41982801)
13
-------
(2) Aerobic Soil Metabolism.
The half-life in an aerobic sandy loam soil was 31 hours
(1.3 days). Metabolites were the sulfone, sulfoxide, and alpha-
hydroxylated sulfone and sulfoxide compounds, which degrade
by beta oxidation to C02.
Uncharacterized residues in the soil extracts were 4.6-
25.8% of the applied dose between 4 and 24 hours after
treatment. No storage stability data are available.
Reanalysis of the soil extracts using another HPLC
column and detector resulted in greater resolution of 14C-
hydroxyethyl octyl sulfide and its metabolites. Most of the
previously uncharacterized radioactivity now appears to be from
the parent compound, based on the results from the new
methodology. The amount of parent compound increased from
53 to 81% for the 4-hour sampling interval, and from 37 to 58%
for the 16-hour sampling interval. The half-life estimate for the
parent compound increased slightly from 0.9 days (21.6 hours) to
1.3 days (31 hours). However, this is not a significant increase
in persistence.
The proportions of metabolites also changed upon
reanalysis of the soil extracts. The concentrations of the
sulfoxide and sulfone metabolites (Metabolites 1 and 2) were
higher in the early sampling intervals upon reanalysis, but
Metabolites 3 and 4 (hydroxylated sulfoxide and sulfone) were
actually lower upon reanalysis. Both the sulfoxide and sulfone
metabolites reached maximum concentrations of approximately
25% by 36-96 hours, but degraded quickly with half-lives of < 1
day. The alpha-hydroxylated sulfoxide and sulfone metabolites
never exceeded 3% of the applied compound. Total residues
increased with the new analytical methodology, and the
uncharacterized residues decreased from a maximum of 25% to a
maximum of 2%. Soil extracts were found to be stable in
storage for approximately 2 years, far longer than the study
duration (30 days).
Hydroxyethyl octyl sulfide degraded with a calculated
half-life of 31 hours (1.3 days) in sandy loam soil that had been
dosed with 10 ppm of the parent compound and aerobically
incubated at 25 +_ 1 °C in darkness for up to 30 days. The
identified metabolites were the sulfone, sulfoxide, and alpha-
14
-------
hydroxylated sulfone and sulfoxide. Beta-oxidation and
decarboxylation were the apparent degradation pathways of the
aliphatic parent compound, based on the increase in soil-bound
material and C02 in the volatility traps with increasing time
(MRIDs 42459401 and 43005501).
(3) Unaged Leaching-Adsorption-Desorption.
Parent hydroxyethyl octyl sulfide is moderately mobile in
Tiffany sand (North Dakota, 0.25% OC), Anthony sandy loam
(Arizona, 0.35% OC), and Dundee clay loam (Mississippi,
0.65% OC) soils with Freundlich Kads values of 1.5, 3.4, and
3.5, and Kdes values of 1.2, 3.3, and 1.9. However,
hydroxyethyl octyl sulfide was bound much more tightly in a
Gardena silt loam soil (North Dakota, 2.1% OC) with Freundlich
Kads and Kdes values of 14.7 and 13.7, respectively. This
indicates that soil organic carbon may bind significant amounts of
the hydroxyethyl octyl sulfide that reaches soil. Koc values were
600, 538, 971, and 700 for adsorption, and Kocdes values were
479, 292, 932, and 654. The 1/n (slope of regression isotherm)
values were 1.02, 1.07, 1.02, and 0.89 for adsorption, and 0.91,
0.74, 1.18, and 1.12 for desorption.(MRID 42208201)
(4) Aqueous Photolysis.
This data requirement was waived because the current use
patterns and label language prohibit direct application to water or
were surface water is present.
(5) Aged Leaching-Adsorption-Desorption.
This data requirement was waived for the current use
patterns because hydroxyethyl octyl sulfide and its metabolites
degrade rapidly in aerobic soil with half-lives of < 2 days.
(6) Terrestrial Field Dissipation.
This data requirement was waived for the current use
patterns because hydroxyethyl octyl sulfide and its metabolites
degrade rapidly in aerobic soil with half-lives of < 2 days.
15
-------
3. Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Terrestrial Animals
(1) Birds
Based on the above studies this chemical is practically
nontoxic to avian species on both an acute oral and subacute
dietary basis. It is unlikely that birds will ingest any residue on
avian food items (i.e. leaves, seed pods, insects) because
hydroxyethyl octyl sulfide is quick to volatilize and, therefore,
would not be available for uptake. In addition, based on the
limited use pattern of hydroxyethyl octyl sulfide products and the
lack of persistence in aerobic soil of both the parent compound
and metabolites, it is unlikely that birds will be exposed through
water. Therefore, nontarget avian species are not likely to be
adversely impacted from the currently registered uses of
hydroxyethyl octyl sulfide.
(3) Insects
Hydroxyethyl octyl sulfide is practically nontoxic to
honeybees. However, its insecticidal use suggests that there is
the potential for adverse affects to nontarget insects.
b. Exposure and Risk to Nontarget Aquatic Animals
Based on the above studies hydroxyethyl octyl sulfide displays
moderate to high toxicity to most aquatic organisms tested to date.
However, it is neither persistent nor mobile in the environment. Taking
into account the relative immobility, the rapid dissipation in soils, and
the use patterns, it is unlikely that hydroxyethyl octyl sulfide will leach
into groundwater.
There is minimal potential for contamination of surface water by
drift from the fogger application method should hydroxyethyl octyl
sulfide be applied in close proximity to surface water. It is stable to
hydrolysis, and may persist if applied directly to water. If aquatic
organisms are exposed to hydroxyethyl octyl sulfide, they may be
adversely impacted. However, the currently registered uses and existing
label restrictions minimize the risk of surface water contamination.
16
-------
c. Endangered Species
In order to lessen the exposure to endangered and/or threatened
species from drift, use of hydroxyethyl octyl sulfide near water is
restricted. Adherence to existing environmental hazards labeling should
lessen the potential for exposure and risks to endangered and/or
threatened species.
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 hydroxyethyl
octyl sulfide active ingredients. The Agency has completed its review of these generic
data, and has determined that the data are sufficient to support reregistration of all
products containing hydroxyethyl octyl sulfide. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregistration
eligibility of hydroxyethyl octyl sulfide, 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 hydroxyethyl octyl sulfide and to determine that hydroxyethyl
octyl sulfide, as specified in this document, can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing hydroxyethyl octyl sulfide as the active ingredients
are eligible for reregistration. 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, etc., and the
data identified in Appendix B. Although the Agency has found that all uses of
hydroxyethyl octyl sulfide, as specified in this document, are eligible for reregistration,
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 products
containing hydroxyethyl octyl sulfide, if new information comes to the Agency's
attention or if the data requirements for registration (or the guidelines for generating
such data) change.
B. Determination of Eligibility Decision
17
-------
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
hydroxyethyl octyl sulfide, the Agency has sufficient information on the health
effects of hydroxyethyl octyl sulfide and on its potential for causing adverse
effects in fish and wildlife and the environment. The Agency has determined
that hydroxyethyl octyl sulfide products, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, the Agency concludes that
products containing hydroxyethyl octyl sulfide for all uses are eligible for
reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of hydroxyethyl octyl sulfide,
as specified in this document, are eligible for reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
hydroxyethyl octyl sulfide. Where labeling revisions are imposed, specific language is
set forth in Section V of this document.
1. Risk Mitigation Measures/Labeling Rationale
Worker Protection
At this time all registered uses of hydroxyethyl octyl sulfide are
outside the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS). The Agency is not establishing any new entry
restrictions at this time for occupational uses of hydroxyethyl octyl
sulfide end-use products because no toxicological endpoints of concern
were identified and no additional risk mitigation measures are
warranted. However, the Agency has concluded that it is prudent to
require a continuation of current minimal label precautions to afford
product users protection from unnecessary exposure. These label
requirements are specified below in Section V and must be retained
and/or added since there may be potential for application and post
application exposure.
Personal Protective Equipment/Engineering Controls for Handlers
18
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1. If the Agency determines that regulatory action on an active
ingredient must be taken as a result of very high acute toxicity or to
certain other adverse effects, such as allergic effects or delayed effects:
* In the RED for that active ingredient, the Agency may
establish minimum or baseline handler PPE requirements
that pertain to all or most end-use products containing the
active ingredient.
* These minimum PPE requirements must be compared
with the PPE that would be designated on the basis of the
acute toxicity of the end-use product.
* The more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, etc.) must be
placed on the label of the end-use product.
2. If the Agency determines that no regulatory action must be taken
as the result of the acute effects or other adverse effects of an active
ingredient, the PPE for pesticide handlers will be based on the acute
toxicity of the end use product. For occupational-use products, PPE
must be established using the process described in PR Notice 93-7 or
more recent Agency guidelines.
The Agency has identified no toxicological endpoints of concern
for hydroxyethyl octyl sulfide that would require the establishment of
personal protective equipment (PPE) or engineering controls based on
the toxicity of the technical hydoxyethyl octyl sulfide. Therefore, as
stated above PPE for pesticide handlers will be based on the acute
toxicity of the end-use products. For occupational-use products, PPE
will be established using the process described in PR Notice 93-7 or
more recent Agency guidelines.
Aquatic Risk Mitigation/Labeling Rationale
From its assessment of the environmental fate and ecotoxicology
data for hydroxyethyl octyl sulfide and in consideration of the outdoor
fogging use, the Agency concludes that a continuation of labeling
precautions and restrictions against surface water contamination is
prudent.
Other Labeling Requirements
19
-------
Other use and safety information is being required for labeling of
end-use products to afford users a greater degree of protection. Refer to
Section V for these label requirements.
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. Generic Data Requirements
The generic data base supporting the reregistration of hydroxyethyl octyl
sulfide for the above eligible uses has been reviewed and determined to be
complete. No additional generic data are required at this time.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an [fill blank with Insecticide,
Herbicide or the applicable term which describes the type of pesticide
use(s)] for the following use(s) [fill blank only with those
uses that are being supported by MP registrant."
An MP registrant may, at his/her discretion, add one of the following statements
to an MP label under
"Directions for Use" to permit the reformulation of the product for
a specific use or all additional uses supported by a formulator or
user group:
(a) "This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
20
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grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
B. End-Use Products
To remain in compliance with FIFRA, end-use product (EP) labeling must be
revised to comply with all current EPA regulations, PR Notices and applicable policies.
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. Labeling Requirements for End-Use Products
a. PPE/Engineering Control Requirements for Pesticide Handlers
Any necessary PPE for each hydroxyethyl octyl sulfide end-use
product will be established on the basis of the end-use product's acute
toxicity. The more protective handler PPE/engineering control
requirement's must be retained. For guidance on which requirements are
considered more protective, as well as the format, the language, and the
requirements location on the end-use product label, see PR Notice 93-7.
b. Application Restrictions
For all end-use products:
"Do not apply this product in a way that will contact any
unprotected person, either directly or through drift. Keep people
and pets out of area during application."
For end-use products formulated as foggers:
"Not for indoor use."
21
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c. User Safety Requirements
For multiple active ingredient end-use products that contain
hydroxyethyl octyl sulfide, the entry restrictions set forth in this section
must be compared to the entry restrictions on the current labeling and the
more protective must be retained. A specific time period in hours or days
is considered more protective than "sprays have dried" or "dusts have
settled." The Agency is requiring the following minimum user safety
requirements for end-use products containing hydroxyethyl octyl sulfide.
For end-use product formulated as foggers:
"Allow spray to disperse for several minutes before allowing people
or pets to enter the treated area."
For all indoor end-use products:
"Do not use in commercial food processing, storage preparation or
serving areas. In the home, all food processing surfaces and utensils
should be covered or removed during treatment and thoroughly
washed before use. Cover and remove food before treatment."
For all other end-use products:
"Do not allow people or pets to touch treated surfaces until the
sprays have dried."
d. User Safety Recommendations
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"If pesticide gets inside clothing, remove clothing immediately,
wash thoroughly and put on clean clothing."
e. Use Limitations
"Do not apply directly to water or wetlands, swamps, bogs,
marshes and potholes, or areas where surface water is present or to
intertidal areas below the mean high water mark. Keep out of lakes
streams and ponds. Do not apply on food crops. Do not apply on
household pets."
22
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"The pesticide should only be applied when the potential for drift
to adjacent sensitive areas (e.g. residential areas, bodies of water,
known habitat for threatened or endangered species, non-target
crops) is minimal (e.g. when wind is blowing away from the
sensitive areas)."
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 hydroxyethyl
octyl sulfide 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.
23
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24
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VI. APPENDICES
25
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26
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Report Run Date: 12/13/95
PRD Report Date: 07/06/95
) Time 15:27
LUIS 2.2 - Page:
APPENDIX A REPORT
Case 3103[2-(Octylthio)ethanol]
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only) otherwise)
Chemical 046301[2-Hydroxyethyl octyl sulfide]
444444444444444444444444444444444444444444444444444444
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
unless noted Max. /crop /year otherwise) /A]
otherwise) Dose cycle /crop /year
cycle
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
)))))))))))))))»:
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
PRL NA
Indoor general surface treatment, When
needed, Aerosol can
NON- FOOD/NON- FEED
PRL
NA
Use Group: INDOOR FOOD
UC * NS NS
UC
NS NS
NS NS AN NS
COMPOST/COMPOST PILES
Spot treatment, When needed, Aerosol can PRL
Spray, When needed, Aerosol can PRL
HOUSEHOLD/DOMESTIC DWELLINGS
Indoor general surface treatment, When PRL
needed, Aerosol can
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Indoor general surface treatment, When PRL
needed, Aerosol can
PRL
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
PRL
Contact and/or surface treatment,
Evening, Aerosol can
PRL
NA
NA
Contact and/or surface treatment, Late PRL
evening, Aerosol can
NA
NA
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS
UC
UC
NS NS
NS NS
NS
NS
NS AN NS
NS AN NS
NS NS NS
NS AN NS
NS NS NS
NS AN NS
NS NS NS
NS AN NS
C92, C94
27
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Report Run Date: 12/13/95 ) Time 15:27
PRD Report Date: 07/06/95
LUIS 2.2 - Page:
APPENDIX A REPORT
Chemical 046301[2-Hydroxyethyl octyl sulfide]
Case 3103[2-(Octylthio)ethanol]
±^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI . .
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Contact and/or surface treatment, When PRL
needed, Aerosol can
PRL
PRL
Directed spray, When needed, Aerosol can PRL
Fog, When needed, Aerosol can PRL
PRL
PRL
Outdoor general surface spray, When PRL
needed, Aerosol can
Outdoor premise treatment, When needed, PRL
Aerosol can
Spot treatment, Nighttime, Aerosol can PRL
PRL
Spot treatment, When needed, Aerosol can PRL
PRL
PRL
Spray, When needed, Aerosol can PRL
ORNAMENTAL AND/OR SHADE TREES
Spray, Foliar, Aerosol can PRL
con ' t )
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: OUTDOOR RESIDENTIAL (con't)
UC
UC
UC
UC
UC
UC
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
AN
NS
NS
AN
AN
AN
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS
28
-------
Report Run Date: 12/13/95 ) Time 15:27
PRD Report Date: 07/06/95
LUIS 2.2 - Page:
APPENDIX A REPORT
Chemical 046301[2-Hydroxyethyl octyl sulfide]
Case 3103[2-(Octylthio)ethanol]
±^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±*±
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI . .
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL GROUND COVER
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
Spray, Foliar, Aerosol can
ORNAMENTAL HERBACEOUS PLANTS
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
ORNAMENTAL LAWNS AND TURF
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
ORNAMENTAL NONFLOWERING PLANTS
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
ORNAMENTAL WOODY SHRUBS AND VINES
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
Spray, Foliar, Aerosol can
PATHS/PATIOS
Contact and/or surface treatment, When
needed, Aerosol can
Use Group
PRL
PRL
PRL
NA
NA
NA
UC
UC
UC
*
*
*
Use Group
PRL
PRL
NA
NA
UC
UC
*
*
Use Group
PRL
PRL
NA
NA
UC
UC
*
*
Use Group
PRL
PRL
NA
NA
UC
UC
*
*
Use Group
PRL
PRL
PRL
NA
NA
NA
UC
UC
UC
*
*
*
Use Group
PRL
NA
UC
*
: OUTDOOR
NS
NS
NS
NS
NS
NS
: OUTDOOR
NS
NS
NS
NS
: OUTDOOR
NS
NS
NS
NS
: OUTDOOR
NS
NS
NS
NS
: OUTDOOR
NS
NS
NS
NS
NS
NS
: OUTDOOR
NS
NS
RESIDENTIAL
NS
NS
NS
RESIDENTIAL
NS
NS
RESIDENTIAL
NS
NS
RESIDENTIAL
NS
NS
RESIDENTIAL
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
C92, C94
29
-------
Report Run Date: 12/13/95 ) Time 15:27
PRD Report Date: 07/06/95
Case 3103[2-(Octylthio)ethanol]
LUIS 2.2 - Page:
APPENDIX A REPORT
Chemical 046301[2-Hydroxyethyl octyl sulfide]
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
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PATHS/PATIOS (con't)
Fog, When needed, Aerosol can
Outdoor premise treatment, When needed,
Aerosol can
Spot treatment, Nighttime, Aerosol can
Spot treatment, When needed, Aerosol can
PET LIVING/SLEEPING QUARTERS
Spot treatment, When needed, Aerosol can
RECREATIONAL AREAS
Contact and/or surface treatment,
Evening, Aerosol can
Contact and/or surface treatment, Late
evening, Aerosol can
Contact and/or surface treatment, When
needed, Aerosol can
Fog, When needed, Aerosol can
PRL
PRL
PRL
PRL
NA
NA
NA
NA
Use Group: OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS NS
UC * NS NS NS NS AN
UC * NS NS NS NS NS
UC * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS AN
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN
NS
NS
NS
NS
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
NA
NA
NA
NA
NA
NA
NA
NA
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
AN
AN
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92, C94
C92, C94
C92, C94
30
-------
Report Run Date: 12/13/95 ) Time 15:28
PRD Report Date: 07/06/95
Case 3103[2-(Octylthio)ethanol]
LUIS 2.2 - Page:
APPENDIX A REPORT
Chemical 046301[2-Hydroxyethyl octyl sulfide]
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
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
RECREATIONAL AREAS (con't)
Outdoor premise treatment, When needed,
Aerosol can
Spot treatment, Nighttime, Aerosol can
Spot treatment, When needed, Aerosol can
REFUSE/SOLID WASTE SITES (OUTDOOR)
Directed spray, Evening, Aerosol can
Directed spray, When needed, Aerosol can
Outdoor general surface spray, When
needed, Aerosol can
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
UC * NS NS NS NS AN NS
UC * NS NS NS NS AN NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS AN NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS AN NS
C92, C94
C92, C94
C92, C94
31
-------
Report Run Date: 12/13/95 ) Time 15:28 LUIS 2.2 - Page: f
PRD Report Date: 07/06/95
APPENDIX A REPORT
Case 3103[2-(Octylthio)ethanol] Chemical 046301[2-Hydroxyethyl octyl sulfide]
44444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate, Maximum Number of Applications at Maximum Rate, Maximum Dose per Crop
Cycle or per Year, Minimum Interval Between Applications (Days), Restricted Entry Interval (Days), Allowed/Disallowed Geographical Areas, Use Limitations Codes.
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)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps © Max. Rate : 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"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
PRL : PRESSURIZED LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : 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, --
APPLICATION RATE
DCNC Dosage Can Not be Calculated
No Calc
W
V
U
cwt
nnE-xx
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
C92 : For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
32
-------
Report Run Date: 12/13/95 ) Time 15:28 LUIS 2.2 - Page:
PRD Report Date: 07/06/95
APPENDIX A REPORT
Case 3103[2-(Octylthio)ethanol] Chemical 046301[2-Hydroxyethyl octyl sulfide]
444444444444444444444444444444444444
USE LIMITATIONS CODES (Cont.)
C94 : Runoff from treated areas may be hazardous to aquatic organisms in neighboring areas.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
33
-------
34
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients
within the case hydroxyetheyl octyl sulfide covered by this Reregi strati on Eligibility Decision Document.
It contains generic data requirements that apply to hydroxyetheyl octyl sulfide 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.
35
-------
36
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Hydroxyethyl octyl sulfide
REQUIREMENT
71-1A Acute Avian Oral - Quail/Duck
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
MRID 41972201
MRID 41972201
MRID 41972201
MRID 41972202
MRID 41972202
MRID 41972202
MRID 41972203
MRID 41972203
MRID 41972203
MRID 41972203
MRID 41972203
MRIDs 41972203, 41983003
MRIDs 41972203, 41982802
waived
MRIDs 41972203, 41983004
waived
MRIDs 41972203, 42060001
ECOLOGICAL EFFECTS
CKM
37
MRIDs 41983001, 41983002
-------
Data Supporting Guideline Requirements for the Reregistration of Hydroxyethyl octyl sulfide
REQUIREMENT
71-2A
71-2B
72-1A
72-1C
72-2A
141-1
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Honey Bee Acute
USE PATTERN
CKM
CKM
CKM
CKM
CKM
CKM
CITATION(S)
MRID 41948001
MRID 41948002
MRID 41910202
MRID 41910203
MRID 41910204
MRID 41982901
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-2
83-3A
84-2A
84-2B
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
21-Day Dermal - Rabbit/Rat
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
CKM
CKM
CKM
CKM
CKM
CKM
CKM
CKM
CKM
CKM
MRID 41772801
MRID 41772802
MRID 41772803
MRID 41772804
MRID 41772805
MRID 41772806
MRID 43123301
MRID 42225802
MRIDs 42658801, 42658802, 42658803
MRIDs 42658801, 42658802
84-4
Aberration
Other Genotoxic Effects
CKM
MRID 42658804
ENVIRONMENTAL FATE
38
-------
Data Supporting Guideline Requirements for the Reregistration of Hydroxyethyl octyl sulfide
REQUIREMENT USE PATTERN CITATION(S)
160-5
Chemical Identity
MRID 41972201
161-1 Hydrolysis
162-1 Aerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorption
164-1 Terrestrial Field Dissipation
C
C
C
C
MRID 41982801
MRIDs 42459401, 43005501
MRID 42208201
WAIVED
39
-------
40
-------
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.
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.
41
-------
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.
42
-------
BIBLIOGRAPHY
MRID
CITATION
41772801 Gabriel, D. (1990) MGK Repellent 874 Code No. 673-90: Acute Oral Toxicity,
Single Level-Rats: Lab Project Number: 90-7122A. Un-published study
prepared by Biosearch Inc. 10 p.
41772802 Gabriel, D. (1990) MGK Repellent 874 Code No. 673-90: Acute Dermal
Toxicity, Single Level-Rabbits: Lab Project Number: 90-7122A. Unpublished
study prepared by Biosearch Inc. 13 p.
41772803 Hershman, R. (1990) MGK Repellent 874 Code No. 673-90: Acute Inhalation
Toxicity, Single Level, 4-Hour Exposure-Rats: Lab Project Number:
90-7122A. Unpublished study prepared by Biosearch Inc. 26 p.
41772804 Bielucke, J. (1990) MGK Repellent 874 Code No. 673-90: Primary Eye
Irritation-Rabbits: Lab Project Number: 90-7122A. Unpublished study
prepared by Biosearch Inc. 14 p.
41772805 Romanelli, P. (1990) MGK Repellent 874 Code No. 673-90: Primary Skin
Irritation-Rabbits: Lab Project Number: 90-7122A. Unpublished study prepared
by Biosearch Inc. 10 p.
41772806 Romanelli, P. (1990) MGK Repellent 874 Code No. 673-90: Guinea Pig
Dermal Sensitization-Modified Buehler Method: Lab Project Number:
90-7122A. Unpublished study prepared by Biosearch Inc. 20p.
41910202 Bowman, J.; Bucksath, J. (1991) Acute Flow-through Toxicity of MGK
Repellant 874 to Bluegill (Lepomis macrochirus): Lab Project Number: 39202.
Unpublished study prepared by ABC Labs, Inc. 320 p.
41910203 Bowman, J.; Bucksath, J. (1991) Acute Flow-through Toxicity of MGK
Repellent 874 to Rainbow Trout (Oncorhynchus mykiss): Lab Project No.
39203. Unpublished study prepared by ABC Labs, Inc. 316 p.
41910204 Blasberg, J.; Butzlaff, T.; Bucksath, J. (1991) Acute Toxicity of MGK
Repellant 874 to Daphnia magna under Flow-through Conditions: Lab Project
Number: 39204. Unpublished study prepared by ABC Labs, Inc. 334 p.
41948001 Grimes, J.; Lynn, S.; Smith, G. (1991) MGK Repellent 874: A Dietary LC50
Study in the Northern Bobwhite: Lab Project Number: 163-118 Unpublished
study prepared by Wildlife International Ltd. 22p.
41948002 Grimes, J.; Lynn, S.; Smith, G. (1991) MGK Repellent 874: A Dietary LC50
Study with the Mallard: Lab Project Number: 163-119. Unpublished study
prepared by Wildlife International Ltd. 22 p.
41972201 Meinen, V.; Sundquist, D. (1991) Product Identity and Composition of MGK
Repellent 874: Lab Project Number: GLP-249/61. Unpublished study prepared
by McLaughlin Gormley King Co. 140 p.
41972202 Meinen, V.; Sundquist, D. (1991) Analysis and Certification of Product
Ingredients for MGK Repellent 874. Unpublished study prepared by
McLaughlin Gormley King Co. 49 p.
41972203 Sundquist, D.; Meinen, V. (1991) Product Chemistry of MGK Repellent 874:
Physical and Chemical Characteristics: Lab Project Number: GLP-250/225.
Unpublished study prepared by McLaughlin Gormley King Co. 33 p.
43
-------
BIBLIOGRAPHY
MRID
CITATION
41982801 Gorman, M. (1991) Hydrolysis of MGK 874 as a Function of PH at 25C: Lab
Project Number: 39311. Unpublished study prepared by ABC Laboratories,
Inc. 41 p.
41982802 Laster, W. (1991) Vapor Pressure at 25C of MGK 874: Lab Project Number:
39312. Unpublished study prepared by ABC Laboratories, Inc. 210 p.
41982901 Blasberg, J. and T. Butzlaff. 1991. Final report for LX119-02 (Repellent 874)
acute contact toxicity study on honey bees in Georgia. Southern Agricultural
Research, Inc., PO Box 5126, 3025 Madison Highway, Valdosta, GA
31603-5126. LANDIS protocol number 1411-91-19-02-21F-01. Submitted by
McLaughlin Gormley King Co., 8810 Tenth Avenue N, Minneapolis, Minn.
55427.
41983001 Campell, S.; Lynn, S.; Smith, G. (1991) MGK Repellent 874: An Acute Oral
Toxicity Study with the Northern Bobwhite: Lab Project Number: 163-120.
Unpublished study prepared by Wildlife International Ltd. 28 p.
41983002 Campell, S.; Lynn, S.; Smith, G. (1991) MGK Repellent 874: An Acute Oral
Toxicity Study with the Mallard: Lab Project Number: 163-121. Unpublished
study prepared by Wildlife International Ltd. 27 p.
41983003 Pesselman, R. (1991) Water Solubility Determination of MGK Repellent 874:
Lab Project Number: HWI 6001-718. Unpublished study prepared by Hazleton
Wisconsin, Inc. 33 p.
41983004 Pesselman, R. (1991) Octanol/Water Partition Coefficient Determination of
MGK Repellent 874: Lab Project Number: HWI 6001-708. Unpublished study
prepared by Hazleton Wisconsin, Inc. 39 p.
42060001 Meinen, V. (1991) Product Chemistry of MGK Repellent 874: Physical and
Chemical Characteristics: Supplemental Information: Lab Project Number:
GLP-225. Unpublished study prepared by McLaughlin Gormley King Co. 20
P-
42208201 Williams, M.; White-Berghaus, L. (1992) Soil/Sediment
Adsorption-Desorption of MGK Repellent 874: Lab Project Number: 39435.
Unpublished study prepared by ABC Labs., Inc. 51 p.
42225802 Irvine, L. (1992) MGK Repellent 874 (R874): Rat Development Toxicity
(Teratology) Study: Lab Project Number: MCA/4/R. Unpublished study
prepared by Toxicol Labs., Ltd. 175 p.
42459401 Williams, M. (1992) Aerobic Soil Metabolism of MGK Repellent 874: Lab
Project Number: 39431. Unpublished study prepared by ABC Laboratories,
Inc. 44 p.
42658801 Meinen, V. (1991) Analysis of Ethanol Dilutions Regarding L5178Y
TK+/-Mouse Lymphoma Mutagenesis Assay: Final Report: Lab Project
Number: GLP-279. Unpublished study prepared by MGK Co. 10 p.
42658802 Meinen, V. (1991) Analysis of Ethanol dilutions Regarding Chromosome
Aberrations in Chinese Hamster Ovary (CHO) Cells: Final Report: Lab Project
Number: GLP-279. Unpublished study prepared by MGK Co. 10 p.
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BIBLIOGRAPHY
MRID CITATION
42658803 Meinen, V. (1991) Analysis of Ethanol Dilutions Regarding
Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay
(Ames Test): Final Report: Lab Project Number: GLP-279. Unpublished study
prepared by MGK Co. lip.
42658804 Meinen, V. (1991) Analysis of Ethanol Dilutions Regarding Unscheduled DNA
Synthesis in Rat Primary Hepatocytes: Final Report: Lab Project Number:
GLP-279. Unpublished study prepared by MGK Co. 10 p.
43005501 Williams, M. (1993) Aerobic Soil Metabolism of MGK Repellent
874-Supplemental Report: Lab Project Number: 394311: N/163/1. Unpublished
study prepared by ABC Laboratories, Inc. 61 p.
43123301 Husband, R. (1994) MGK Repellent 874: 21 Day Dermal Toxicity Study in the
Rabbit: Lab Project Number: MCA/21/C: MCA/21/93. Unpublished study
prepared by Toxicol Laboratories, Ltd. 182 p.
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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).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 1 U.S.C. section 136a(c)(2)(B). Collection of this information
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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.
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.
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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 ©
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 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
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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
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)
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(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 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
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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).
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."
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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.
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.
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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.
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.
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.
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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).
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,
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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.
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
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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.
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
57
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58
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HYDROXYETHYL OCTYL SULFIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing hydroxyethyl octyl sulfide.
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 reregi strati on of
hydroxyethyl octyl sulfide. 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) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this hydroxyethyl octyl sulfide Product Specific
Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for hydroxyethyl octyl
sulfide are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on hydroxyetheyl octyl sulfide 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 reregi strati on of all eligible hydroxyethyl octyl sulfide
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 Jean Holmes at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Jean Holmes
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: hydroxyethyl octyl sulfide
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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.
60
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61
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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 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
62
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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 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
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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.
64
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65
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66
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67
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68
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EPA'S BATCHING OF 2-HYDROXYETHYL OCTYL SULFIDE PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing 2-Hydroxyethyl octyl sulfide 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. Not with-standing 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 registrants' 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 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.
69
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Twenty six products were found which contain 2-hydroxyethyl octyl sulfide as an active
ingredient. The products have been placed into 5 batches in accordance with the active and inert
ingredients, type of formulation and current labeling. Table 1 identifies the products in each batch.
Table 2 identifies the products that could not be batched.
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Table 1
Batch
EPA Reg. No.
% Active Ingredient
Formulation
Type
499-342
11715-27
432-526
2-hydroxyethyl octyl Sulfide 1.00
Permethrin 0.265
2-Hydroxyethyl octyl Sulfide 1.00
Permethrin 0.284
2-hydroxyethyl octyl Sulfide 1.00
Permethrin 0.28
Pressurized
Liquid
4822-161
4822-99
432-617
2-hydroxyethyl octyl sulfide l.OOd-
Trans Allethrin 0.223 Resmethrin
0.188
2-hydroxyethyl octyl Sulfide 1.00 d-
Trans Allethrin 0.222 Resmethrin
0.188
2-hydroxyethyl octyl sulfide 1.00 d-
Trans Allethrin 2.00 Resmethrin
0.0750
4822-82
4822-56
2-hydroxyethyl octyl sulfide 1.00
Methoxychlor 1.00
Piperonyl Butoxide 1.00
Pyrethrins 0.020
4822-184
4822-185
2-hydroxyethyl octyl sulfide 1.00
d-trans allethrin 0.223 Sumithrin
0.084
3282-68
3282-17
2-Hydroxyethyl octyl Sulfide 1.50
Trans Allethrin 1.08
MGKSynergist 0.500
2-Hydroxyethyl octyl
Sulfide 1.00
Piperonyl Butoxide 0.150
MGK Synergist 265 0.250
Pyrethrins 0.075
Pressurized
Liquid
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Table 2
No
Batch
EPA Reg. No.
1021-676
1021-851
1021-1241
1021-1495
1021-1541
1021-1026
1021-912
1021-1046
3282-25 *
239-2421 *
9688-50 *
% Active Ingredient
2-hydroxyethyl octyl Sulfide 94.37
2-Hydroxyethyl octyl Sulfide 50.00
MGKSynergist 12.50
Piperonyl Butoxide 7.50
1-Hydroxy ethyl octyl Sulfide 27.4
Piperonyl Butoxide 27.4
Esbiol concentrate 3.49
other isomers 0.275
2-Hydroxyethyl octyl Sulfide 25.00
d-cis-trans Allethrin 5.0
Multicide pynamin
forte 1.88
2-Hydroxyethyl octyl Sulfide 20.0
MGK 264 synergist 10.0
Piperonyl Butoxide 6.0
2-Hydroxyethyl octyl Sulfide 10.0
d-Trans allethrin 2.23
2-Hydroxyethyl octyl Sulfide 9.091
MGK 264 Synergist 2. 275
Piperonyl butoxide 1.365
Premium Pyrocide 3.412
2-Hydroxyethyl octyl Sulfide 10.00
Piperonyl Butoxide 3.31
d-Trans Allethrin 0.74
Methoxychlor 13.34
2-Hydroxyethyl Octyl Sulfide 1.50
Trans allethrin 0.1
Piperonyl Butoxide 0.05
2-Hydroxyethyl octyl
Sulfide 1.00
Resmethrin 0.2840
2-Hydroxyethyl octyl Sulfide 0.950
Piperonyl Butoxide 0.150
MGK Synergist 0.250
Pyrethrins 0.075
Formulation
Type
Liquid
tt tt
tt tt
tt tt
tt tt
tt tt
tt tt
tt tt
Pressurized
Liquid
tt tt
tt tt
72
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No
Batch
EPA Reg. No.
478-80 *
4822-309 *
475-175
% Active Ingredient
2-Hydroxyethyl octyl Sulfide 0.950
Trans Allethrin 0.1 12
Resmethrin 0.375
Permethrin 0.575
2-Hydroxyethyl octyl Sulfide 0.500
Trans Allethrin 0.1425
Permethrin 0.154
2-Hydroxyethyl octyl Sulfide 0.500
Resmethrin 0.2280
Formulation
Type
tt tt
tt tt
tt tt
* Data in category III or IV from EPA 3282-25 may be bridged to registrations marked with
asterisk, but these registrations cannot be batched.
73
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74
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ATTENTION CRM::: PLEASE NOTE:::
REMOVE THIS PAGE AND INSERT THE LIST OF
REGISTRANTS RECEIVING THIS DCI
75
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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.
76
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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 Reg. 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 of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
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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 reregistration 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 hydroxyetheyl octyl sulfide 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 Jean Holmes at (703)-308-8008.
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 hydroxyethyl octyl sulfide.
The following documents are part of the Administrative Record for hydroxyethyl octyl sulfide
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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