&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-95-039
August 1995
Re registration
Eligibility Decision (RED)
Alkyl Imidazoline
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United States
Environmental Protection
Agency *
Prevention, Pesticides
And Toxic Substances
(75O8W)
EPA-738rF-95-034
August 1995
R.E.D. FACTS
Alkyl Imidazoline
Pesticide All pesticides sold or distributed in the United States must be
Reregistration registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1,1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
, complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used:
without posing unreasonable risks to human Health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
; This fact sheet summarizes the information in the RED document for
reregistration case 3010, Alkyl Imidazoline.
Use Profile
Alkyl imidazoline (l-(2-Hydroxyethyl)-2-alkyl*-2-imidazoline) is. a
microbiocide/microbiostat used in fuel and oil storage tank bottom water. It
prevents the growth of slime-forming bacteria and fungi which might
interfere with the use and quality of oils and fuels in storage tanks.
Formulations include two soluble concentrate liquid products, one with
1.19% and the other with 25.0% active ingredient. Products are loaded and
applied through a closed delivery system that has a proportioning pump or
siphon-type feeder to meter the pesticide product directly from its container
into the fuel oil as it is pumped into storage tanks. Products are not
intended for homeowner use or for use in or around residences.
Regulatory Products containing alkyl imidazoline were registered in the United
History States in 1970. Currently, 2 products are registered for use as a
microbiocide in fuel oil.
Human Health Toxicity
Assessment In studies using laboratory animals, alkyl imidazoline generally has
been shown to be of mild acute toxicity via oral and dermal routes. It has
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been placed in Toxicity Category III (indicating the next to lowest degree of
acute toxicity) for these effects. However, alkyl imidazoline is highly
corrosive and a severe eye and skin irritant. It is placed hi Toxicity
Category I (indicating the highest degree of acute toxicity) for these
effects. , ;
The appropriate toxicological endpoint for assessing short-term or
intermediate-term occupational risk for alkyl imidazoline is maternal
toxicity. Developmental toxicity studies using rats showed decreased body
weight gain, decreased food consumption, and decreased food efficiency.
Dietary Exposure
Alkyl imidazoline has no registered food uses. Application is via a
closed delivery system in industrial sites only. No dietary exposure is
expected.
Occupational and Residential Exposure
Minimal occupational and no residential exposure are expected from
the current uses of alkyl imidazoline. These products are loaded and applied
through a closed delivery system that has a proportioning pump or siphon-
type feeder to meter the pesticide product directly from the product
container into the fuel oil as it is pumped into storage tanks. Products are
used in industrial sites and are not intended for homeowner use or for use in
or around residences. ' . . -
Environmental
Assessment
Human Risk Assessment
No significant human health risk is expected from the use of alkyl
imidazoline. Based on the exposure assessment and the toxicological
endpoint of concern (developmental toxicity), the calculated risks to
handlers are well within the boundaries that the Agency considers
reasonable. Furthermore, post-application exposure to workers should be
minimal because of the dilution of the product in fuel oil bottom water and
precautions that are used to minimize exposure to fuel oil. (
Environmental Fate
EPA has not required environmental fate testing to support the
reregistration eligibility decision for alkyl imidazoline. Etecause of the
pesticides limited use pattern, only in fuel storage tanks, high dilution rate,
and use only in closed systems, alkyl imidazoline is expected to result in
minimal exposure to the environment when used according to directions on
the label. Also, alkyl imidazoline has chemical properties that suggest it will
remain in the organic phase (fuel/oil) of any mixture with water.
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Risk Mitigation
Additional Data
1 flhelina
Chnges R* qtrired
Ecological Effects
Due to its indoor non-food use pattern, us'e only in closed systems,
high dilution rates, and the high probability that it will remain in the fuel
portion of any mixture with water, EPA expects minimal environmental
exposure and has not required extensive studies on the ecotoxicology of
these alkyl imidazoline products. However, the Agency is requiring acute
toxicity studies on birds, fish, and aquatic invertebrates. The Agency will
use these data to characterize alkyl imidazoline's acute toxicity to these non-
target species in case of accidents and to determine appropriate
environmental labeling for products. '
Ecological Effects Risk Assessment
EPA has not. conducted an ecological risk assessment for alkyl
imidazoline because it is only used inside fuel storage tanks. Exposure to
the environment is expected to be negligible. If contaminated water is
pumped from tanks holding fuel treated with alkyl imidazoline, the
pesticide concentration in the water should be very low due to its high
dilution rate and its affinity to the organic (fuel) phase of the mixture.
Treated fuel must be disposed of in accordance with U.S. EPA's Resource
Conservation and Recovery Act (RCRA).
To lessen the human health risks posed by alkyl imidazoline, EPA is
requiring the following risk mitigation measures.
6 Use of PPE, personal protective equipment; and
o Continued use of closed delivery systems (historically used).
No environmental risk rnitigation measures are being imposed for
alkyl imidazoline because exposure to the environment is expected to be
negligible. : .
The generic data base supporting the reregistration of alkyl
imidazoline has been reviewed and determined to be substantially complete.
The registrant must submit three acute ecotoxicity studies to characterize
alkyl imidazoline's toxicity to fish, birds, and aquatic invertebrates. This
information is required for labeling in case of an accident or misuse of the
pesticide product or technical material.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration., .
All alkyl imidazoline end-use products must Comply with EPA's
Pesticide Product labeling re{iuirements ** with ^ following- For
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a comprehensive list of labeling requirements, please see1 the Alkyl
Imidazoline RED document. i
Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be
contained in an effluent discharged to the waters of the United States
or municipal sewer systems must bear the effluent discharge labeling
statements as described in PR Notice 93-10. i
Labeling Requirements for End-Use Products
Handler (Mixer. Loader. Applicator) PPE .'
The Agency is imposing minimum personal protective
equipment (PPE), long-sleeve shirt, long pants, chemical-resistant
gloves, shoes, and socks for the application of the currently registered
alkyl imidazoline products and is not imposing post-application entry
restrictions. If the end-use product is classified as toxicity category I
or II for eye irritation potential, protective eyewear is also required.
The requirements are based on the absence of significant lexicological
concerns for alkyl imidazoline. However, the Agency may find that
imposing the use of more protective PPE and/or other restrictions
could be necessary upon the review of toxicity data for the end-use
products during product reregistration.
Labeling Requirements
The Agency is requiring the following labeling statements to be
Ipcated on all end-use products containing alkyl imidazoline that are
intended primarily for industrial or occupational use.
"Do not apply this product in a way that will contact workers or other
persons. Only protected handlers may be in the area during
application." ' ;
Engineering Controls:
"Since handlers must use closed metering systems, the handler
requirements are reduced to long-sleeve shirt, long pants, chemical-
resistant gloves, shoes, and socks."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
there are no such instructions for was.hables, use detergent and hot
water. Keep and wash PPE separately from other laundry."
User Safety Recommendations: -;
• "Users should remove clothing immediately if pesticide gets inside.
Users should wash thoroughly and put on clean clothing."
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Regulatory
Conclusion
For More
Information
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Application Method Timing and Equipment:
"The registrant must state when the preservative is added. For
example:' Alkyl imidazoline products are loaded and applied through
a closed delivery system that has a proportioning pump or siphon-type
feeder to meter the pesticide product directly from the container into
the fuel oil as it is pumped into storage tanks'."
Effluent Discharge Labeling Statements: „
Refer to Labeling Requirements for Manufacturing-Use Products
above for labeling requirements for effluent discharge.
The use of currently registered products containing alkyl imidazoline
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration. - .
Alkyl imidazoline products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and-accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for alkyl imidazoline during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet 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.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information, ,
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Alkyl Imidazoline RED document
also will be available from the National Technical Information Service
.(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
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For more information about EPA's pesticide reregistration program,
the Alkyl Imidazoline RED, or reregistration of individual products
containing alkyl imidazoline, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000. !
For information about the health effects of pesticides, or for assistance
hi recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time," Monday through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
, WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
MRT
6 1996
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 alkyl imidazolines
which includes the active ingredient l-(2-hydroxyethyl)-2-alkyl-2-imidazoline. The enclosed
Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base of
these chemicals, its conclusions of the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and products will
be eligible for reregistration. The RED includes the data and labeling requirements for
products for reregistration. It may also include requirements for additional data (generic) on
the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Moana Appleyard (703) 308-8175. Address any questions on required generic data to the
Special Review and Reregistration Division representative Alan Dixon (703) 308-8043.
Sincerely yours,
Enclosures
jis Rossi, Division Director
Special Review
and Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION EMGffilLJTY DECISION (RED)
1. DATA CALL-IN (DCI) OR "%-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later man the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 GFR §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.l75(e). A copy of
the CSF is enclosed; follow the instructions on its back.
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e< Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product. ;
-Comments
RED ma^sub^d » to 1U.-UKH.. m the F^eral
Lfwi.LuJLiiJ.Ug vv/ i«*»w WM*»«- —— w , a
Register Notice which announces the availability of this
TO RBND PRODUCT SPECIFIC PCI RESPONSES (90-PAY) AND
FOR REREGISTRATION (8-MONTH RESPONSES)
BvU.S.Maa;
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 I
1921 Jefferson Davis Hwy. • • j
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 date ,
waiver and time extension requests within 60 days. EPA will also try to respond to£ 8-
month submissions with a final ^registration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Alkyl imidazolines
LISTC
CASE3010
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ALKYLIMIDAZOLINES REREGISTRATION ELIGIBILITY DECISION TEAM ..... i
EXECUTIVE SUMMARY v
I. INTRODUCTION ... . . . . ..... ... . . . ....... 1
n. CASE OVERVIEW . . . . 2
A. Chemical Overview 2
B. Use Profile ................. .; . , . . ................... 2
C. Regulatory History 3
HI. SCIENCE ASSESSMENT .'. . . . 3
A. Physical Chemistry Assessment . . ; ..... 3
B. Human Health Assessment........... . . 4
1. Toxicology Assessment ............... ... .4
a. AcuteToxicity ................. .^ 5
b. Subchronic Toxicity ........ ..;.-.;.•... :V. .. 1..-....,. 6
c. Developmental Toxicity ......................... 6
d. Mutagenicity ...... 7
e. Toxicolpgical Endpoints for Risk Assessment . 7
f. Reference Dose . 7
g. Other Toxicity Considerations .. . . . 8
2. Exposure Assessment . . . . . . ... . . . .... .......... . ; . . . 8
a. Dietary Exposure ...... . . . .-'. ................. 8
b. Occupational and Residential 8
3. Risk Assessment . 9
a. Dietary ....;...... . . ; 9
b. Occupational and Residential .........;.......... 9
C. Environmental Assessment 11
1. Environmental Fate . * 11
2. Ecological Effects ................ ... ............. 11
a. Ecological Effects Data . . . .... ...... . . . 11
b. Ecological Effects Risk Assessment ................ 12
TV. RISK MANAGEMENT AND REREGISTRATION DECISION .......... .12
A., Determination of Eligibility 12
B. Determination of Eligibility Decision 13
1. Eligibility Decision . . . . 13
2. Eligible and Ineligible Uses ............ . . . ..... .... . 14
C. Regulatory Position . . .14
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V. ACTIONS REQUIRED OF REGISTRANTS .'. ,. /. . • .14
A. Manufacturing-Use Products 14
1. Additional Generic Data Requirements 14
2. Labeling Requirements for Manufacturing-Use Products 15
B. End-Use Products • • • /• 15
1. Additional Product-Specific Data Requirements .......... r. 15
2. Labeling Requirements for End-Use Products . . . . . 16
C. Existing Stocks . 17
VI. APPENDICES • . ..... 19
APPENDIX A. Table of Use Patterns Subject to Reregistration ....... 20
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision . . 23
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Alkylimidazolines 28
APPENDIX D. Product Specific Data Call-In 31
Attachment 1. Chemical Status Sheets 45
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions ........; 45
Attachment 3. Product Specific Requirement Status aind Registrant's
Response Forms (Form B inserts) and Instructions 48
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration .53
Attachment 5. List of All Registrants Sent This Data Call-In (insert)
Notice . • ;....•..'.....:• 54
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 55
APPENDIX E. List of Available Related Documents 61
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ALKYLIMTOAZOLINES REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and .Economic Analysis Division
Phyllis Johnson
Rafael Prieto ,
Kathleen Vinlove
Environmental Fate and Effects Division
Mary Frankenberry .
Nick Mastrota
Jose Melendez
Health Effects Division
Winston Dang
Linda Kutney
Raymond Locke
Registration Division
Harold PodaU
ShyamMathur
Joanne Hayes
Marion Johnson, Jr.
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis & Coordination Branch
Ecological Effects Branch
Environmental Fate & Groundwater Branch
Occupational & Residential Exposure Branch
Risk Characterization & Coordination Branch
Toxicology Branch I
Registration Support Branch
Registration Support Branch
Registration Support Branch
Product Management Team 31
Special Review and Reregistration Division
Alan Dixon
Bruce Sidwell
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Office of General Council
Kevin Lee .
Food Safety and Regulations Section
Office of Enforcement and Compliance Assurance
Rick Colbert , Agriculture and Ecosystems Division
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct tenn 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
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are mot 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 .
LC30 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.
LD30 Median Lethal Dose. A statistically derived single dose mat can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LD,0 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 hi drinking water under the Safe Drinking Water Act.
/ig/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
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level . I .
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 j
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion ,
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q- The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC ' RedBloodCell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard ^^
SLN Special Local Need (Registrations Under, Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect. ,
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient i
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 j
WPS Worker Protection Standard j . -
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed its reregistration assessment of the
available information on the pesticide active ingredient l-(2-hydroxyethyl)-2-alkyl-2-imidazoline,
which comprises the chemical case alkyl imidazolines. The Agency has determined that the
currently registered uses of this pesticide will not cause unreasonable risk to humans or the
environment and that these uses and products containing alky! imidazolines are eligible for
reregistration.
Alkyl imidazoline is a microbiocide/microbiostat used in fuel and oil storage tank bottom
water. It is used to prevent the growth of slime-forming bacteria and fungi which might interfere
with the use and quality of oils and fuels in storage tanks. Formulations include two soluble
concentrate liquid products, one with 1.19% and the other with 25.0% active ingredient. Products
are loaded and applied through a closed delivery system that has a proportioning pump or siphon-
type feeder to meter the pesticide product directly from the product container into the fuel oil as
it is pumped into storage tanks. Products are not intended for homeowner use or for use in or
around residences.
Alkyl imidazoline has moderate oral toxicity. It is highly corrosive and is a severe eye and
skin irritant. The use patterns and application method for alkyl imidazoline products indicate the
potential for exposure to handlers is minimal. The lexicological endpoint of concern used for
human exposure risk assessment was the 15 mg/kg body weight/day LOEL based on a
developmental toxicity in rats. Because of alkyl imidazoline's limited use pattern, it is expected
that there will be minimal exposure to the environment when alkyl imidazoline is used according
to the directions on the label. Also, the chemical has properties that suggest it will remain in the
organic phase (fuel/oil) in any mixture with water.
Before reregistering products containing alkyl imidazoline, the Agency is requiring that
product specific data and revised labeling be submitted within eight months of the issuance of this
document. These data include product chemistry and acute toxicity testing for each registration.
Also, three confirmatory studies on ecotoxiciry are required to indicate appropriate environmental
precautionary labeling in case of product accidents.
The registrant must submit these acute ecotoxicity studies to characterize alkyl
imidazoline's toxicity to fish, birds, and aquatic invertebrates in case of an accident or misuse of
the pesticide product or technical material. The registrant committed to provide this information
in their Phase 2 Response, dated 10/21/89. The Agency reviewed the studies submitted to meet
these requirements and found them inadequate.
The acute avian and acute fish studies were performed by IBT laboratories. Because of
serious problems that were discovered in an audit of this laboratory, studies that they performed
are automatically invalidated. These studies must be repeated. Although it does not meet guideline
requirements, the aquatic invertebrate study submitted may be adequate for labeling purposes if
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the registrant submits additional data about the study. If this information is unavailable, a new
study must be submitted. ,
After reviewing these data and any revised labels and finding them acceptable, the Agency
will reregister a product based on whether or. not it meets the requirements in Section 3(c)(5) of
FIFRA that is whether product composition and labeling are acceptable and the product's uses
will not'cause unreasonable adverse effects to humans or the environment. Those products which
contain other active ingredients will be eligible for reregistration only when the active ingredients
in addition to alkyl imidazoline are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four phases
of the process focus on identification of data requirements to support the reregistration of an
active ingredient and the generation and submission of data to fulfill the requirements. The fifth
phase is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of
all data submitted to support reregistration.
•" - *
FIFRA Section 4(g)(2)(A) states that in Phase Five "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 alkyl imidazoline. The document consists of six sections.
Section I is the introduction. Section n describes alkyl imidazoline, its uses, data requirements
and regulatory history. Section ffl discusses the human health and environmental assessment based
on the data available to the Agency. Section IV presents the reregistration decision for alkyl
imidazoline. Section V discusses the reregistration requirements for alkyl imidazoline. 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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n.
CASE CVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision: : ~ -
• Common Name: PR-471, alkyl imidazoline
Chemical Name:
l-(2-hydroxyethyl)-2-allcyl*-2-imidazoline (*as in
fatty acids of tall oil)
CAS Registry Number: 61791-39-7
OPP Chemical Code: 046609
Average Empirical Formula:
Average Molecular Weight: 350.58
Trade and Other Names: Nalco 2210, Fuel-prep 1000
Basic Manufacturer:. Nalco Chemical Company
B. Use Profile
Type of Pesticide:
Use .Sites:
Pests:
Microbiocide/Microbiostat (slime-formiEg bacteria and
fungi)
Indoor Non-food—Fuels/Oil Storage Taiik Bottom Water
Additive i -
Slime-forming bacteria and fungi
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Formulation Types Registered:
Type: End use
Form: , _ Soluble concentrate/liquid, 1.19% and 25.0%
Methods and Rates of Application:
Types of Treatment: . Preservative treatment
i - • . L
Metering pump
Not on labels; needs to be defined by registrant.
Equipment:
Timing:
Rate of Application:
From 10 to 20 ppm active ingredient by weight based on
fuel oil
Use Practices Limitations: Use in closed systems only. Do not discharge into lakes,
streams, ponds, or public waters.
C. Regulatory History
Products containing l-(2-Hydroxyethyl)-2-alkyl*-2-imidazoline (*as in fatty acids
of tall oil) were registered in the United States in 1970. Currently, 2 products are
registered for use as a microbiocide in fuel oil. The company of record is Nalco/Exxon
Energy Chemicals. Two Data Call-in notices have been issued: The Antimicrobial Data
Call-in of March 4,1987, and a Registration Phase 4 Data Call-in of September 1992.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color:
Physical State:
Odor:
Boiling Point:
Density:
Hazy, dark amber
Liquid
Slight, "amine-like"
> 200°C at 20 mm Hg
0.940 ± .005 at 25°C
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Solubility:
Vapor Pressure:
Dissociation
Constant:
Octanol/Water.
Partition Coef.:
Stability:
8 mg/L (Water)
< 0.2 psi (or 10.34 mm Hg) .
7.43 (15 mole %); 10.34 (85 mole %)
28,500 |
Stable in presence of metal and metal ions at normal
temperature and temperatures up to 200°C. The
product darkens on long exposure to sunlight.
B. Human Health Assessment
i •' • .' • .
1. Toxicology Assessment
The toxicological database on the pesticide active ingredient l-(2-
hydroxyethyl)-2-heptadecenyl-2-imidazoline is adequate and will support
reregistration.
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a. Acute Toxicity
ACUTE TOXICITY DATA
Table 1.
TEST
Oral LD50- rat
(MRID No.: 42293001)
Dermal LD50 - rabbit
(MRID No.: 42293002)
Inhalation LCSO
Ocular Irritation - rabbit (one
female) (MRID No.: 42293004)*
Primary dermal irritation - rabbit
(males and females)
(MRID No.: 42293003)*
Dermal sensitization - guinea pig*
RESULTS
1948 (1259-2638) mg/kg males
1880 (1213-2546) mg/kg females
1932 (1515-2349) mg/kg combined
LD50 = > 2000 mg/kg
males and females
Waived due to corrosivity
Severe eye irritant: caused
conjunctiva! irritation with
blistering, and severe swelling at 24
hours post-treatment.
Severe skin irritant: caused
persistent erythema and eschar
formation; primary dermal irritation
index, P.LI. =5.0
Waived due to corrosivity
CATEGORY
m
m
1
I
Note: Data pertaining to primary eye irritation, and dermal sensitization are not required to support the reregistration
of the TGAI. -These data are presented for informational purposes.
, V
Alkyl imidazoline, l-(2-Hydroxyethyl)-2-alkyl*-2-imidazoline
(*as in fatty acids of tall oil), has been tested in the following acute toxicity
tests. With Sprague-Dawley rats (MRID No. 42293001), alkyl imidazoline
demonstrated an acute oral LD50 of 1948 (1259-2638) mg/kg body weight
for male rats, 1880 (1213-2546) mg/kg for female rats, and 1932 (1515-
2349) mg/kg for combined sexes. An acute dermal toxicity test with male
, , and female New Zealand White rabbits (MRID No. 42293002)
demonstrated that the, acute dermal LD50 is greater than 2000 mg/kg body
weight for both males and females.
•
Alkyl imidazoline was a severe eye irritant in a test in one female
New Zealand White rabbit (MRID No. 42293004)5 causing cornea!
opacity, iritis, conjunctiva! irritation with blistering, and extreme swelling
at 24 hours post-treatment. Although the eye irritation study was conducted
-------
with only one rabbit, which would normally make the study unacceptable,
the study was otherwise well-conducted and the results placed this corrosive
chemical in Toxicity Category I (severe eye irritant) for eye effects. It is
the Agency's opinion that additional eye irritation studies would be of little
added value and would be inhumane to the test animals.
In a study of primary dermal irritation in both male and female New
Zealand rabbits (MRID No. 42293003), alkyl imidazoline was a severe
skin irritant, causing persistent erythema and eschar formation (primary
dermal irritation index = 5.0).
b. Subchronic Toxicity ; . . , ,
Due to the use pattern of this chemical, subchronic studies were not
required or submitted. Alkyl imidazoline products are loaded and applied.
through a dosed delivery system that has a proportioning pump or siphon-
type feeder to meter the pesticide product directly from the product
container into the fuel oil as it is pumped into storage tanks. Products are
not intended for homeowner use or for use in or around residences. The
use patterns and application method for alkyl imidazoline products indicate
the potential for exposure to handlers is minimal.
c. Developmental Toxicity
Pregnant Sprague-Dawley derived CD® rats, 24 per group, were
administered Mazola® Corn Oil solutions of test material by gavage during
gestation days 6-15 (MRID No. 42293008). The doses used were 0, 15,
65, or 100 mg/kg bw/day. The purity (active ingredient content) of alkyl
imidazoline was 85±3%.
Based on the clinical signs of toxicity (excessive salivation and/or
staining of the skin/fur in the anogenital area), the Maternal Toxicity
LOELis 15 mg/kg/day (LDT) and the Maternal Toxicity NOEL is < 15
mg/kg/day. In addition, maternal body weight gain, food consumption,
and food efficiency decreases were observed at 65 and 100 mg/kg/day.
Treatment at the high-dose (100 mg/kg/day) level resulted in two maternal
deaths, with none occurring at other treatment levels.
Alkyl imidazoline had no effect on any of the developmental toxicity
parameters examined, at the three dose levels tested. No indications of any
developmental effects attributable to treatment were observed in this study.
The Developmental Toxicity NOEL is ^ 100 mg/kg/day (HOT), and the
Developmental Toxicity LOEL is > 100 mg/kg/day.
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d. Mutagenicity
Alkyl imidazoline was evaluated in a Salmonella typhimurium/Ames
plate incorporation assay in tester strains TA1535, TA1537, TA1538,
TA98, and TA100, with and without metabolic activation (S9),, at
concentrations of 0, 1.0, 3.3, 10, 33, or 100 fig/plate. None of the doses
tested induced increases in the number of reveitant colonies. Cytotoxicity
was induced at 100 jig/plate. Thus, alkyl imidazoline did not induce
mutations in Salmonella typhimurium strains when tested up to cytotoxic
levels (MRID No. 42293007).
Alkyl imidazoline did not induce chromosomal aberrations in
Chinese hamster ovary (CHO) cells when tested at concentrations of 0,
0.0013, 0.0025, 0.005, or 0.01 pi/ml without metabolic activation (S9) or
at concentrations of 0, 0.0065, 0.013, 0.025, or 0.05 /tl/rnl with metabolic
activation (S9). The chemical was tested up to cytotoxic levels (0.01
Ml/ml/-S9; 0.05jtl/ml/+S9) (MRID No. 42293005).
Alkyl imidazoline did not induce unscheduled DNA synthesis in
primary rat hepatocyte cultures treated up to eytotoxic levels (0.03 /tl/ml),
as determined by radioactive tracer procedures (nuclear silver grain
counts). Dose levels used were: 0, 0.001, 0.003, 0.006, 0.01, and 0.03
/tl/ml (MRID No. 42293006).
e. Toxicological Endpoints for Risk Assessment
Less-Than-Lifetime Toxicity Considerations
No acute or chronic dietary risk assessment is required since alkyl
imidazoline is not a food-use chemical and no significant endpoint has been
identified in the available toxicity studies. The appropriate lexicological
endpoint for assessing short-term or intermediate-term occupational risk for
alkyl imidazoline is the 15 mg/kg body weight/day LOEL for maternal
toxicity (decreased body weight gain, decreased food consumption, and
decreased food efficiency) which was observed in the rat developmental
toxicity study (MRID No. 42293008).
f.
Reference Dose
The RfD was not established due to insufficient data. However, it
is not essential to establish a RfD since alkyl imidazoline is not used on
food. This class of chemicals has not been reviewed by the Food and
-------
Agriculture Organization (FAO) and World Health Organization (WHO)
Joint Meeting on Pesticide Residues (JMPR).
g. Other Toxicity Considerations
All other toxicity studies have been waived for this chemical due
either to its use pattern or corrosivity. ;
* '
2. Exposure Assessment
,' ! "
a. Dietary Exposure
Alkylimidazoline has no registered food uses. Application is via a
closed delivery system in industrial sites only. No dietary exposure is
expected. •
b. Occupational and Residential
Alkyl imidazoline, is used as a preservative and fungicide to inhibit
slime-forming bacteria and fungi growth in fuel oil storage tank bottom
water. Formulations include two soluble concentrate liquid products, one
, with 1.19 % and the other with 25.0 % active ingredient,
Alkyl imidazoline products are loaded and applied through a closed
delivery system that has a proportioning pump or siphon-type feeder to
meter the pesticide product directly from the product container into the fuel
oil as it is pumped into storage tanks. Products are not intended for
homeowner use or for use in or around residences.
- . I ; • ' '• : :: •.
The use patterns and application method for alkyl imidazoline
products indicate the potential for exposure to handlers is minimal. Based
on the exposure assessment and the toxicological endpoint of concern,
calculated risks to handlers resulted in margin of exposures (MOEs) greater
than 100. Furthermore, post-application exposure to workers should be
minimal because of the dilution of the product in fuel oil bottom water and
precautions that are used to minimize exposure to fuel oil. No additional
exposure data are required.
(1) Mixer/loader/applicator Exposure
The amount of alkyl imidazoline-in the storage fuel depends
upon the end-use dilution. Potential for exposure to handlers and
workers is believed to be minimal because of the use of a closed
8
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delivery system for loading and application as recommended by the
product labels. The only possible exposure is during coupling and
uncoupling of the loading valve or during transfer of the end-use
product container to the metering pump. Primary exposures are
expected to be limited to the dermal and inhalation routes.
(2) Post-Application Exposures
There are several types of potential exposures to persons
after application. Potential for exposure exists (through both
dermal and inhalation routes) to industrial/manufacturing workers
immediately after alkyl imidazoline use and to workers exposed to
fuel oil containing alkyl imidazoline. These exposures could come
from dermal contact with fuel treated with alkyl imidazoline and or
from breathing the vapors or combustion gases from fuel treated
with alkyl imidazoline.
Since the amount of diluted alkyl imidazoline in oil/fuel
mixtures is minimal (40 to 80 ppm), adverse effects from dermal
and inhalation exposure are expected to be minimal. '
Based on the existing use pattern of alkyl imidazoline, post-
application exposure data are not needed.
3. ' Risk Assessment
a. Dietary
Alkyl imidazoline has no food uses. No dietary risk is expected.
b. Occupational and Residential
The registrant, Nalco Chemical Company, is a participant of the
Chemical Manufacturers Association (CMA) Antimicrobial Exposure
Assessment Study. The unit exposure,(UE) derived from this study's
Maximum Credible Sum (MCS) can be applied to, this exposure assessment
.method.
"Nalco 2210" (EPA Reg. 1706-101) containing 25 percent active
ingredient (alkyl imidazoline) is added to fuel oil to achieve a concentration
of 40 to 80 ppm. Assuming 10,000 gallons of oil/fuel are treated with
"Nalco 2210," a total of 0.8 gallons of product must be added to achieve
the highest label-allowed concentration. Assuming one gallon of "Nalco
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2210" weighs 8.5 pounds, and 25 percent of each gallon is active
ingredient, a total of 1.7 pound of active ingredient would be handled per
10,000 gallons of oil/fuel. Since the application methods are limited to
closed delivery metering pump systems, the CMA exposure study for
liquid-pump application and pour liquid methods can be used to estimate
daily exposure to applicators, as summarized in the following tables.
The estimated Actual Daily Exposure (ADE) is 0.21 ug/kg/day when
closed delivery systems are used and all routes of exposure are included,
and 3.97 ug/kg/day when an open pouring liquid system is applied. These
correspond to margin of exposures (MOEs) of 71,428 and 3,788
respectively.
To provide a quantified comparison between the estimate of the
toxicological endpoints and exposure for handlers, the Agency uses the
following equation for calculating the MOE:
MOE = Toxicological endpoint (mg/kg/day)
Daily exposure (ing/kg/day)
i ,„ .
The Agency believes that an MOE greater than 100 indicates an acceptable
risk. For both methods the MOE for alkyl imidazoline is at least an order
magnitude greater than 100 and therefore represents an acceptable risk.
Table 2. Pump Liquid Application
; r & 4 ;^tpoo& ' ;:- -s<^;r^y:^ *
Setting
Preservative
UE*
(ug/lb ai)
7.5
Ibai/
used
1.7
BW**
(kg)
60
Actual Daily
Exp(ug/kg/day)
0.21
* UE «= Unit Exposure was derived from CMA Study (Amended report, 1992) with gloves, inner parameters
only.
** BW - Body Weight
Actual Dailv Exoosure (ue/ke/day) = (UE X Ib ai/used) / BW
Margin Of Exposure (MOE) = LOEL/ADE = 15,000/0.21 = 71,428
for pump liquid application. Based on a 15 mg/kg body weight/day LOEL which was
observed in the rat developmental toxicity study (MRID.No, 422930Q8).
10
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Table 3. Open Pouring Liquid Application Method
/ i . ' '/ ',- ', *; ">>' * ••- ' "- ""'-„;»?" /''''„„'>
Setting
Preservative
UE*
(ug/lb ai)
140
Ibai/
used
1.7
BW**
(kg)
60
Actual Daily
Exp(ug/kg/day)
3.97 >
* UE = Unit Exposure was derived from CMA Study (Amended report, 1992) with gloves, inner parameters
only. Based on CMA study, one replicate exposed to chemical during work for Cooling Tower without gloves
had Unit Exposure = 47,930 ug/lb a.i. handled.
** BW = Body Weight
Actual Daily Exposure (ug/kg/day) = (UE X Ib ai/used) / BW
Margin Of Exposure CV1OE) = LQEL/ADE = 15,000/3.97 = 3,778
for open pouring method. Based on a 15 mg/kg body weight/day LOEL which was observed in the rat
developmental toxicity study (MRIP No.42293008). .
C. Environmental Assessment
1. Environmental Fate ,
The Agency has not required any environmental fate testing, including
hydrolysis, to support the reregistration eligibility decision for alkyl imidazoline.
Because of its limited use pattern, only in fuel storage tanks, high dilution rate and
use only in closed systems it is expected that there will be minimal exposure to the
environment when alkyl imidazoline is used according to the directions on the
label. Also, the alkyl imidazoline has properties that suggest it will remain in the
organic phase (fuel/oil) of any mixture with water. '
2. Ecological Effects
a. Ecological Effects Data
Due to its indoor non-food use pattern, use only in closed systems,
high dilution rates and the high probability that it will remain in the fuel
portion of any mixture with water, the Agency expects minimal
environmental exposure and has not required extensive studies on
ecotoxicology of these alkyl imidazoline products. However, the Agency
is requiring acute toxicity studies on birds, fish, and aquatic invertebrates.
11
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The Agency will use these data to characterize alkyl imidazoline1 s acute
toxicity to these non-target species in case of accidents and to determine
appropriate environmental labeling for products.
The registrant committed to provide this information in their Phase
2 Response, dated 10/21/89. The Agency reviewed the studies submitted
to meet these requirements and found them inadequate.
The acute avian and acute fish studies were performed by ffiT
laboratories. Because of serious problems that were discovered in an audit
of this laboratory, all studies it performed are automatically invalidated.
These studies must be repeated.
Although it does not meet guideline requirements, the aquatic
invertebrate study may be adequate for labeling purposes if the registrant
submits additional data about the study. If this information is unavailable,
a new study must be submitted.
b. Ecological Effects Risk Assessment
The Agency has not conducted an ecological risk assessment for
alkyl imidazoline because it is only used inside fuel storage tanks.
Exposure to the environment is expected to be negligible. If contaminated
water is pumped from tanks holding fuel treated with alkyl imidazoline, the
pesticide concentration in the water should be very low due to its high
dilution rate and its affinity to the organic (fuel) phase of the mixture.
Treated fuel must be disposed of in accordance with the U.S.
Environmental Protection Agency's Resource Conservation and Recovery
Act (RCRA).
The need for precautionary labeling statements will be determined
after receipt and review of the ecotoxicity studies noted above.
IV. RISK MANAGEMENT AND KEREGISTRATION 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
12
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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 alkyl imidazoline as an active ingredient.
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 alkyl imidazoline.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of alkyl imidazoline, 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 alkyl imidazoline and to determine that products containing alkyl
imidazoline can be used without resulting in unreasonable adverse effects to humans and
the environment. The Agency therefore finds that all products containing alkyl imidazoline
as the active ingredient are eligible for reregistration. The reregistration pf 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 mat all uses of alkyl imidazoline 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 alkyl imidazoline, 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 , .
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient alkyl
imidazoline, the Agency has sufficient information on the health effects of alkyl
imidazoline and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that alkyl imidazoline 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 alkyl imidazoline for all
registered uses are eligible for reregistration.
13
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2. Eligible and Ineligible Uses
The Agency has determined that all registered uses of alkyl imidazoline are
eligible for reregistration.
1 '..(,••• ~ •''"•
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for alkyl
imidazoline. Where labeling revisions are imposed, specific language is set forth in
Section V of this document. . !.',',
The Agency is imposing only minimal PPE, user safety requirements, and safety
recommendations for the use of alkyl imidazoline products. This is due to low worker
exposure from the use of closed delivery systems and the absence of significant
toxicological concerns for alkyl imidazoline. However, the Agency may find that imposing
the use of more protective PPE and/or other restrictions could be necessary upon review
of toxicity data for the end-use products during product reregistration.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of alkyl imidazoline for
the above eligible uses has been reviewed and determined to be substantially
complete. Required additional data are discussed below:
The registrant must submit three acute ecotoxicity studies to characterize
alkyl imidazoline's toxicity to fish, birds, and aquatic invertebrates in case of an
accident or misuse of the pesticide product or technical material.
•i i
The acute avian and acute fish studies were performed by E3T laboratories.
Because of serious problems that were discovered in an audit of this laboratory,
all studies it performed were automatically invalidated (data reported by these
studies cannot be used). These studies must be repeated. ,
14
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Although it does not meet guideline requirements, the aquatic invertebrate
study may be adequate for labeling purposes if the registrant submits additional
data about the study. If this information is unavailable, a new study must be
submitted.
~N . , '".."•,
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems
must bear the effluent discharge labeling statements as described in PR Notice
93-10. .
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
; product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific date requirements are listed in Appendix F, 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 5) and if not, commit
to conduct new studies. If a registrant believes that previously submitted date 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.
15
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2. Labeling Requirements for End-Use Producfts
* >•••',• I •
Handler (Mixer, Loader, Applicator) PPE |
The Agency is imposing minimum personal protective equipment (PPE),
long-sleeve shirt, long pants, chemical-resistant gloves, shoes, and socks for the
application of the currently registered alkyl imidazoline products and is not
imposing post-application entry restrictions. If the end-use product is classified as
toxicity category I or H for eye irritation potential, protective eyewear is also
required. The requirements are based on the absence of significant toxicological
concerns for alkyl imidazoline. However, the Agency may find that imposing the
use of more protective PPE and/or other restrictions could be necessary upon the
review of toxicity data for the end-use products during product: reregistration.
Labeling Requirements
The Agency is requiring the following labeling statements to be located
on all end-use products containing alkyl imidazoline that are intended primarily
for industrial or occupational use. j '
"Do not apply this product in a way that will contact workers or other
persons. Only protected handlers may be in the area during
application."
Engineering Controls: !
"When handlers use closed metering systems, the handler
requirements may be reduced or modified to long-sleeve shirt,
long pants, chemical-resistant gloves, shoes, and socks."
User Safety Requirements: j
"Follow manufacturer's instructions for cleaning/maintaining
PPE. If there are no such instructions for washables, use
detergent and hot water. Keep and wash PPE separately from
other laundry."
I •
I » • ,
User Safety Recommendations:
"Users should remove clothing immediately if pesticide gets
inside. Users should wash thoroughly and put on clean clothing."
16
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"Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly and change into clean clothing."
Application Method Timing and Equipment:
"The registrant must state when the preservative is added. For
example: 'Alkyl imidazoline products are loaded and applied
through a closed delivery system that has a proportioning pump
or siphon-type feeder to meter the pesticide product directly from
the container into the fuel oil as it is pumped into storage
tanks'."
Effluent Discharge Labeling Statements:
Refer to subsection A. above for labeling requirements for
effluent discharge.
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 alkyl
imidazoline 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.
17
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GUIDE TO APPENDIX B
kix B contains listings of data requirements which support the reregistration for active ingredients within the
yl imidazolines covered by this Reregistratipn Eligibility Decision Document. It contains generic data
lents that apply to Alkyl imidazolines in all products, including data requirements for which a "typical
ktion" is the test substance.
The data table is organized in the following format:
ll. Data Requirement (Column 1), The data requirements are listed in the order in which they appear in 40
t158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide
ent Guidelines, which are available from the National Technical Information Service, 5285 Port Royal
[jpringfield, VA 22161 (703) 487-4650.
I. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply.
[lowing 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
J. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the
fing number of each study, This normally is the Master Record Identification (MRID) number, but may be a
imber if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of
tiy: .''.•/
23
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BIBLIOGRAPHY
MRID
CITATION
12293001
12293002
12293003
142293004
I42293Q05
J42293006
142293007
42293008
42434701
42434702
42434703
43126801
43373101
43373102
43379001
70
36
Reagan, E. (1990) Acute Oral LD50 Study of EH & S 588 in
>Sprague-Dawley Rats: Lab Project Number: 90.2075.046.
Unpublished study prepared by Food arid Drug Research Labs.
p. -' - ' ','"'• '
Reagan, E. (1990) Acute Dermal Toxicity Study of EH & S 588 in
NevrZealarid White Rabbits: Lab Project Number: 90.2075.047.
Unpublished study.prepared by Food and Drug Research Labs.
P-
Reagan, E. (1990) Primary Dermal Irritation Study of EH & S 588
:in New Zealand White Rabbits: Lab Project Number: 90.2075.049.
Unpublished study prepared by Food and Drug Research Labs.
28 p. - ' .
Reagan, E. (1990) Primary Eye Irritation Study of EH & S 588 in
New Zealand White Rabbits: Lab Project Number: 90.2075.048.
Unpublished study prepared by Food and Drug Research Labs. 30
p. : • ' ' ''.'•'"'•
Putman, D.; Morris, M. (1990) Chromosome Aberrations in
Chinese Hamster Ovary (CHO) Cells: EH & S 588: Final Report:
Lab Project Number: T9412.337. Unpublished study prepared by
Microbiological Associates, Inc. 29 p.
Curren, R. (1990) Unscheduled DNA Synthesis in Rat Primary
Hepatocytes: EH & S 593: Final Report: Lab Project Number:
T9412.380. Unpublished study prepared by Microbiological
Associates, Inc. 27 p.
San, R.; Wagner, V^ (1990) Salmdnella/Mammalian-microsome
Plate Incorporation Mutagenicity Assay (AMES Test): Final
Report: Lab Project Number: T9412. 501. Unpublished study
prepared by Microbiological Associates, Inc. 54 p.
Schroeder, R. (1992) A Teratogenicity Study in Rats with EH &S
592: Final Report: Lab Project Number: 90-3613. Unpublished _"
study prepared by Bioi/dynamics, Inc. 447 p.
White, J. (1989) Product Identity and Composition. Unpublished
study prepared by Nalco Cemicl Co. 48 p.
Mbachu, R.; Street, T. (1990) Analytical Method for
Enforcement. Unpublished study prepared by Nalco Chemical Co.
11 P- . ' ••'-.•'. ''.'•.
Mbachu, R.; Street,' T. (1990) Physical arid Chemical Properties.
Unpublished study prepared by Nalco Chemical Co. 4 p.
White, J. (1994) Product Identity and Composition: Alkyl
Imidazolines and Imidazoliam quaternaries. Unpublished study
prepared by Nalco Chemical Co. 47 p.
White, J. (1994) Physical and Chemical Properties:
(Imidazoline): Lab Project Number: PR/471. 'Unpublished study
. prepared by Nalco Chemical Co. 4 p.
Fletcher, D.,; Rausina, G. (1994) Toxicity Studies: (NALCO
2210): Lab Project Number: 651/07084: 621/07083. Unpublished
study prepared by industrial-Bio-Test Laboratories, Inc. 40 p.
White, J. (1994) Physical and Chemical Properties:
1-(2-Hydroxyethyl)-2-heptadecenyl-2-imidazoline. ,
29
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BIBLIOGRAPHY
MRID
CITATION
Unpublished study prepared by Nalco Chemical Co. 14 p.
43379002 Ward, T.-j Magazu, 0V; Boeri, R. (1994) Toxicity Studies1:
1-(2-Hydroxyethyl)-2-heptadecenyl-2-imidazoline: (Static Acute
Toxicity of EH&S 686 to the Daphnid, Daphnia magna: Ariaended
Report): Lab Project Number: 513-NA. Unpublished study
prepared by T. R. Wilbury Labs, Inc. 19 p. ,
30
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m)
It fMffF
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460 1
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 IE 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 hi this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section ffl-B); or
31
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3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section m-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).
* * ' . ' - i ' •• *
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection^of tiiis
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section H - Data Required By This Notice
Section m- 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!. 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
32
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generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient. ,
" ' /
SECTION n. DATA REQUIRED BY THIS NOTICE
H-A. DATA REQUIRED
The product specific data required by this Notice are specified hi Attachment 3,
Requirements Status and Registrant's Response Form. Depending on th& results of the studies
required hi this Notice, additional testing may be required. .
H-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.
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established. :
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
1
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 j 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)].
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY ~~. ~~~~~
33
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Unless otherwise noted herein, this Data Call-fr 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 seen 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 HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
ffl-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.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s). .
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section m-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-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'is Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options, Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-Li
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
34
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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 hi 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 ffl-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 ffl-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.
m-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), men 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 hi 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 cqst-share (Offers to Cost Share)
(4) I am submitting an existing study that has riot 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)
35
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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).
" • . i "
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 me 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 simihir 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.
36
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Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrants) developing the data has refused to
accept your offer. To qualify for mis 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 Date, 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.
; /*
y • • "
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:
37
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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 I60.3(k), means "any material
derived from a test system for examination or analysis." |
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study .fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and mat 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 {ill 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
38
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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 MPJD number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
39
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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. ;
m-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.
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.
40
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7.
8.
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).
, • *'
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ffl-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
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 Calil-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. ;
9.
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.
Failure to take any requked 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,
41
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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, reqiiirements^referenced or included in tihis 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 CANCELLED 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 cither 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.
42
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Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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.
43
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-Li 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.
r\ . ••' : • . . •
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.
,h '. .; .,. , •;/ ,'..:, , •-
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 Product Specific Data Report Form
44
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ALKYL IMroAZOLINES DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-Li Notice because you have product(s)
containing Alley! imidazolines. • -
' • • " • . •• • ,• ' • ' . • ' • /
This Product Specific Data Call-in Chemical Status Sheet contains ah overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of Alkjr
imidazolines. This attachment is tobe used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) tb
Requirements Status and Registrant's Form (Attachment. 3), (4) EPA's Grouping of End-Ue
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 Alkyl imidazolines Product Specific Data
Call-In (Attachment 7). Instructions and guidance accompany each form.
• ' ' - ' ' „ f i • .'
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the ditabase for Alkyl imidazolines are
contained in the Requirements Status and Registrant's Response Attachment 3. The Agency has
concluded that additional data on Alkyl imidazolines are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Alkyl imidazolines products. .
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Alkyl imidazolines, pleae
contact Alan Dixon at (703) 308-8043.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Moana Appleyard at (703) 308-8175.
All responses to this Notice for the Product Specific,data requirements should be submitted
tb: ' •'•.-'''• " ..
Moana Appleyard
Chemical Review Manager Team 81
Product Reregistration Branch , ' '
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
/ •= • • '"--•'•'•.:. 45 •'• ' , .
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46
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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.
47
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48
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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 guidelines 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, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (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?. 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 Documents 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 mis 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.
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 on 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
49
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committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
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 me party which is committing to submit or provide the require 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 ffl-
C. 1.) apply as well.
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 HI-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.
i , • . J
5. By the specified due date, I will submit or cite date to upgrade a study
classified by the Agency as partially acceptable and upgrade (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. Twill 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 ffl-C.l.) apply.
i , , • , • i ., - .
6. By the specified due date, I will cite an .existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
50
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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 require 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 chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NQTE;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 mat your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
51
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52
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EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING ALKYL
IMIDAZOLINE FOR PURPOSES OF 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 reregistration of end-use products containing the active ingredient
Alkyl imidazoline, the Agency considered batching end-use products. This process involves
grouping similar products 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.).
However, batching of end-use products containing Alkyl imidazoline was not possible after
considering the available information described above. Table I lists all the end-use products
containing Alkyl imidazoline. These products were either considered not to be similar for purposes
of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
each product '•' • .
Registrants must generate all the required acute lexicological studies for each of their products.
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 cited, the registrant must
clearly identify the material tested by its 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 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). Since the end-use products containing Alkyl imidazoline could not be
batched, registrants cannot choose from the remaining options: Cost sharing (Option 2) or Offers to
Cost Share (Option 3).
Table I. End-Use Products Containing ALKYL IMIDAZOLINE
EPA Reg. No.
68708-3
68708-4
% of Alkyl imidazoline
25
1.19
Formulation Type
liquid
' liquid
53
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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:
•s . ',''.'.-" - •
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.
55
-------
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
56
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&EPA
United States Environmental Protection 'Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OUB No. 2070-0108
1070-0057
Approval Expire* 3-31-96
PubDc 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.
CompuyNa
Cimpuny Number
Product Name
F.PA Rcj-.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 Rodenticlde 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):
Nam* of Flrm(a)
Date of OWer
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 (Pleaae Type or Print)
EPA Form 8570-32 (S/91) Replaces KPA Fonn 858U, which is obsolete
-------
-------
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
; reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
ig instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
(jtion of information, Send comments regarding the burden estimate or any otheraspect of this collection of information,
iling suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
[cy, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
^0106), Washington, DC 20503.
> fill in blanks below. '
any Name
ot Name
Company Number
> /
EPA Reg. No.
rthat:
|For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
3A) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
•submitter to cite that study.
|lhat for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am "the
al data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
Jjany(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
|1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
trement 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
luirements Status and Registrants'Response Form,"
(That I have previously complied with section 3(c)(1)(F) of FFRA for the studies I have cited in support of registration or
gistration under FIFRA.
Date
> and Title (Please Type or Print)
JER AL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
gistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
ure
Date
i and Title (Please Type or Print)
l 8570-31 (4-96)
-------
62
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The following is a list of available documents related to Alkyl imidazolines. It's purpose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Alkyl imidazolines and ae included in the EPA's Office
of Pesticide Programs Public Docket.
,1. Health and Environmental Effects Science Chapters
2. DetailedLabelUsageInformation System (LUIS)Report
3. Alkyl imidazolines RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingrediert
Statement
63
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64
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