United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-F-99-003
March 1999
&EPA
Reregi strati on
Eligibility Decision (RED)
Virelure
((Z)-11 -hexadecenal)
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O1W)
EPA-738-F-99-033
March 1999
R.E.D. FACTS
Vireluire
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be
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 feet sheet summarizes the information in the RED document for
reregistration case 4118, virelure.
Vifelure is an insect pheromone that attracts male artichoke plume
moths. They are either attracted to a trap, where they become entrapped and
die, or the release of the pheromone from a dispenser disrupts their mating
activity. The mode of action is non-toxic.
A manufecturing-use product and two end-use products are presently
registered for virelure. End-use products are twist-ties that are distributed
throughout the affected area.
Because of its containment, virelure's use sites are considered
terrestrial non-food. The artichoke plume moth is only a pest of artichokes;
therefore, virelure would be used hi areas where artichokes are grown.
Virelure was first registered as a pesticide in the U.S. in 1981. In
1989, there were three registered end-use products and two registered
manufacturing-use products. As of 1996, one manufecturing-use product
and two end-use products were registered; all other products were canceled
for non-payment of maintenance fees. Data on product chemistry were
received in response to a Data Call-in in 1993.
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Human Health
Assessment
Toxicity
Adequate mammalian toxicology data on virelure are available for its
use in a solid-matrix dispenser and will support a Reregistration Eligibility
Decision (RED). Oral and inhalation toxicology indicate that virelure is
practically nontoxic by these routes. Studies submitted for eye and dermal
irritation resulted in a classification of Toxicology Category m.
Environmental
Assessment
Dietary Exposure
Since there are no food uses of virelure, dietary exposure is not
expected.
Human Risk Assessment
Based on the use pattern, the potential for dermal and eye exposures to
pesticide handlers exists but is expected to be negligible. Residential
exposure is not expected based on the use pattern.
Adequate data are available to satisfy adverse risk concerns to
nontarget organisms. Virelure is practically nontoxic to terrestrial animals.
Virelure is highly toxic to freshwater invertebrates and creates an oily
surface film on water that may adversely affect organisms that utilize the
water surface. Based on its uses, studies for non-target plants are not
required.
Based on the use pattern, the potential for exposure to non-target
organisms is not expected.
Additional Data The generic database supporting the reregistration of virelure for the
Required above eligible uses has been reviewed and determined to be substantially
complete. Therefore, there are no further generic data requirements being
imposed at this time.
Product Labeling Tlie labels of all registered pesticide products containing virelure must
Changes Required comPlv witb- EPA's current pesticide product labeling requirements. In
addition:
NPDES Statement - Manufacturing-use product labels must contain the
following NPDES statement: "Do not discharge effluent containing this
active ingredient into lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specifically identified and addressed in an
NPDES permit. Do not discharge effluent containing this product to sewer
systems without previously notifying the sewage treatment plant authority.
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For guidance contact your State Water Board or Regional Office of the
EPA."
Precautionary Statement - The following statement should appear under the
"Precautionary Statement" heading on the label: "Causes slight eye and
dermal irritation. Avoid contact with eyes, skin, or clothing. Wash
thoroughly with soap and water after handling."
Environmental Hazard - The following statement should appear under the
"Environmental Hazards" heading on the label: "This product is highly toxic
to aquatic invertebrates. Do not apply directly to water or to areas where
surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water by cleaning of equipment or disposal of
equipment washwaters."
Non-Food Use - In conformity with virelure's non-food use, labels should
contain the statement: "Do not contaminate water, food or feed by storage or
disposal."
Regulatory
Conclusion
For More
information
Based on the review of the generic data for the active ingredients
virelure, the Agency has sufficient information on the health effects of
virelure and on its potential for causing adverse effects hi fish and wildlife
and the environment. The Agency has determined that virelure products,
labeled and used as specified hi the Reregistration Eligibility Decision, will
not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, the Agency concludes that, for products containing
virelure in twist-tie dispensers, all uses are eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (REID) document for virelure during a 60-day tune period, as
announced hi a Notice of Availability published hi 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.
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Printed copies of the RED and feet 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, fex 513-489-8695.
Following the comment period, the virelure RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the virelure RED, or reregistration of individual products containing
virelure, please contact Robyn Rose (703) 308-9581 or the Biopesticides and
Pollution Prevention Division (7511WC), OPP, US EPA, Washington, DC
20460, telephone
703-308-8712.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
Robyn Rose (703) 308-9581 or the Biopesticides and Pollution Prevention
Division (7511C), OPP, US EPA, Washington, DC 20460, telephone (703)
308-8712.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
revised reregistration eligibility review and decisions on the pesticide chemical case virelure
which includes the active ingredient (Z)-l 1-hexadecenal. 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 ElED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of
suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3,1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA
implementation, EPA recognizes that it will be necessary to make decisions relating to FQPA
before the implementation process is complete. In making these early case-by-case decisions,
EPA does not intend to set broad precedents for the application of FQPA. Rather, these early
determinations will be made on a case-by case basis and will not bind EPA as it proceeds with
further policy development and any rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
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If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Biopesticides and Pollution Prevention Division representative Robyn
Rose(703) 308-9581.
Sincerely yours,
Biopesticides and Pollution Prevention Division
Enclosures
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REREGISTRATION ELIGIBILITY DECISION DOCUMENT
Virelure
LISTD
CASE 4118
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
BIOPESTICIDES AND POLLUTION PREVENTION DIVISION
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TABLE OF CONTENTS
Virelure Registration Eligibility Decision Document
(Case 4118
PC Code 120001)
VIRELURE REREGISTRATTON ELIGIBILITY DECISION DOCUMENT TEAM I
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Regulatory History 4
DDE. SCIENCE ASSESSMENT 6
E. Physical Chemistry Assessment 6
F. Human Health Assessment 7
1. Toxicology Assessment 7
2. Exposure Assessment 9
3. Human Risk Assessment 10
G. Environmental Assessment 11
1. Ecological Toxicity Data H
2. Environmental Fate 12
3. Exposure and Risk Characterization 13
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 14
H. Determination of Eligibility 14
1. Eligibility Decision '.'.'.'.'.14
2. Eligible and Ineligible Uses 14
I. Regulatory Position 15
1. Food Quality Protection Act Considerations 15
2. Tolerance Reassessment 16
3. Endangered Species Statement 16
4. Labeling Rationale 16
V. ACTIONS REQUIRED OF REGISTRANTS 17
J. Manufacturing-Use Products 17
1. Additional Generic Data Requirements 17
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VI.
2. Labeling Requirements for Manufacturing-Use Products 17
K. End-Use Products 18
1. Additional Product-Specific Data Requirements , 18
2. Labeling Requirements for End-Use Products 18
APPENDICES
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VERELURE REREGKTRATION ELIGIBILITY DECISION DOCUMENT TEAM
Office of Pesticide Programs:
Biopesticides and Pollution Prevention Division
Shanaz Bacchus
Frank W. Ellis, Jr.
Richard King
Robyn Rose
Laura Sallmen Smith
Roy Sjoblad
Freshteh Toghrol
Gail Tomimatsu
Biological and Economic Analysis Division
Margaret Cogdell
Cynthia Douchore
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FAOAVHO
FDA
FIFRA
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA
HDT
LD,
'so
LDto
LEL
LOG
LOD
LOEL
Acceptable Daily Intake. A now defunct term for reference
dose (RfD).
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL
represents a medium specific (i.e. drinking water) lifetime
exposure at which adverse, non carcinogenic health effects are
not anticipated to occur.
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a terrestrial
ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health
Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal
guidance to municipalities and other organizations when
emergency spills or contamination situations occur.
Highest Dose Tested
Median Lethal Concentration. A statistically derived
concentration of a substance that can be expected to cause
death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or
feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that
can be expected to cause death in 50% of the test animals
when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Effect Level
ill
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MATC
MCLG
mg/L
MOE
MP
MPI
MRID.
N/A
NOEC
NPDES
NOEL
NOAEL
OP
OPP
Pa
PADI
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRN
Q*i
RBC
RED
REI
RfD
RS
RUP
SLN
TC
TD
TEP
TGAI
TLC
TMRC
torr
ug/L
WP
WPS
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is
used by the Agency to regulate contaminants in drinking water
under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of
recording and tracking studies submitted.
Not Applicable
No effect concentration
National Pollutant Discharge Elimination System
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate
Office of Pesticide Programs
pascal, the pressure exerted by a force of one newton acting
on an area of one square meter.
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice.
The Carcinogenic Potential of a Compound, Quantified by the
EPA's Cancer Risk Model
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24 (c) of
FIFRA)
Toxic Concentration. The concentration at which a substance
produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic
effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1
mm high under standard conditions.
Micrograms per liter
Wettable Powder
Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency (hereafter referred to as the "Agency" or
"EPA") has completed an assessment of the potential human health risk and environmental risks
associated with the pesticidal use of the lepidopteran pheromone, (Z)-ll-hexadecenal or virelure.
Virelure is a naturally occurring lepidopteran pheromone with a non-toxic mode of action.
Virelure is used in agriculture as a sex attractant, disrupting the mating activity of the male
artichoke plume moth. Because virelure is a naturally occurring lepidopteran pheromone with a
non-toxic mode of action, it is classified as a biopesticide (biochemical).
The Agency has determined that the use of virelure, as currently registered (a pheromone
attractant and mating disrupter) for use in artichoke fields, will not cause unreasonable risk to
humans or the environment when used in accordance with label directions. An exemption from the
requirements of tolerance has been established at 40CFR 180.1153 for lepidopteran pheromones
that are naturally occurring compounds, or identical or substantially similar synthetic compounds,
designated by an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol,
aldehyde or acetate functional group and containing up to 3 double bonds in the aliphatic backbone.
This exemption pertains to only those situations when the pheromone is applied to growing crops
at a rate not to exceed 150 grams active ingredient/acre/year hi accordance with good agricultural
practices.
Although human health and ecological risk assessments indicated that virelure is generally
non-toxic and exposures are unlikely, the Agency, after a comprehensive reassessment of the
toxicology data base, has concluded that a potential for eye and dermal irritation does exist, and
thus, will be requiring additional precautionary labeling addressing this issue. The Agency also
notes that in laboratory testing situations, virelure may create an oily film on water that could
adversely affect certain aquatic invertebrates; therefore, EPA will require special precautionary
labeling statements warning against contamination of water bodies.
Before reregistering the products containing virelure, the Agency is requiring that a revised
Confidential Statement of Formula (CSF) and revised product labeling be submitted within eight
months of issuance of this document. After reviewing this information and finding it acceptable
hi accordance with Section 3(c)(5) of FIFRA, the Agency will reregister these products. Those
products containing virelure hi combination with other active ingredients will be eligible for
reregistration only when the other active ingredients are determined to be eligible for reregistration.
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregistration process to be completed in nine
years. There are five phases to the reregistration process. The first four phases of the process focus
on identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the
U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted to
support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from
the currently registered uses of the pesticide; to determine the need for additional data on health
and environmental effects; and to determine whether the pesticide meets the "no unreasonable
adverse effects" criterion of FIFRA.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 301 et seq., and the FIFRA, 7 U.S.C. 136 et seq. The FQPA amendments went into
effect immediately. Among other things, FQPA amended the FFDCA by establishing a new safety
standard for the establishment of tolerances. The FQPA did not, however, amend any of the
existing reregistration deadlines in section 4 of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of virelure. The document consists of six sections. Section I is the introduction.
Section n describes virelure, its uses, data requirements and regulatory history. Section HI
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for virelure . Section V discusses the
reregistration requirements for virelure. 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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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
B.
Common Name:
Chemical Name:
Chemical Class:
CAS Registry Number:
OPP Chemical Code:
Case Number:
Empirical Formula:
Virelure
(Z)-l 1-hexadecenal
Lepidopteran pheromone
53939-28-9
120001
4118
Trade and Other Names: 1. AgriSense Technical Pheromone Z-
-2. APM-ROPE™
Basic Manufacturer:
1. Thermo Triology Corporation
9145 Guilford Rd., Suite 175
Columbia, MD 21046
2. Mitsubishi International Corporation
520 Madison Ave
New York, NY 10022
Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A summary of the currently-registered use of virelure
is contained in Appendix A.
Type of Pesticide for Single Active Ingredient:
Biochemical (pheromone, attractant)
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Mode of Action:
Virelure is an insect pheromone that attracts male adult artichoke plume moths.
They are either attracted to a trap, where they become entrapped and die, or the release of
the pheromone from a dispenser disrupts their mating activity. The mode of action is non-
toxic.
Use Sites:
Terrestrial non-food crops: artichokes
Target Pest:
Platyptilia carduidactyla, artichoke plume moth
Formulation Types Registered:
In addition to the manufacturing-use product, one end-use product containing
virelure is registered. The currently registered end-use product is applied via a dispenser
twist-tied to the inside of an artichoke stalk.
Method and Maximum Rates of Application:
The end-use dispenser products are applied at rates of 400 APM-ROPE dispensers
per acre. Pheromones are generally applied at rates below 150 grams per acre per year.
Equipment:
Individual dispensers (traps or twist-ties)
Timing:
Apply after planting; either immediately before moths emerge or after an insecticide
treatment to eradicate existing moth infestations.
Use Practice Limitations:
Do not apply directly to water or wetlands
C. Estimated Usage of Pesticide
The usage would not likely exceed 500 Ibs. a.i. per year.
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D. Regulatory History
Virelure was first registered in the United States in 1981: In 1989, there were three
registered end-use products and two registered manufacturing-use products. All of these
end-use products contained (Z)-ll-hexadecenal, and one also contained (Z)-9-tetradecenal.
Both pheromones were previously included in this reregistration case. In 1991, all of the
end-use products and one of the manufacturing-use products were canceled for non-payment
of maintenance fees. April 10, 1997, BIOSYS Corporation (company number 67250)
transferred the registration of virelure to Thermo Triology (company number 70051). As
of the publication of this document two products were registered: one manufacturing-use
product containing (Z)-ll-]tiexadecenal (AgriSense® Technical Pheromone Z-ll; EPA
Registration Number 70051-32; Registered September 23,1985), and one end-use product
(APM-ROPE™; EPA Registration Number 50675-8; Registered February 8, 1996). No
registrations remain for (Z)-9-tetradecenal; thus, only (Z)-ll-hexadecenal is covered in this
document.
In 1993, a Data Call-in was issued for virelure. Data on product chemistry were
received in response to the Data Call-In. The Agency has subsequently reduced data
requirements for pheromones such as virelure, and the remaining guideline studies have
been satisfied.
A number of actions have been taken by the Agency to provide regulatory relief for
pheromones. In February of 1993, the Agency published in the Federal Register, a final
rule exempting inert materials in polymeric matrix dispensers from the requirement of a
tolerance (58 FR 64493, Inert ingredients of semiochemical dispensers; tolerance
exemption). An exemption from the requirement of a tolerance for inert ingredients of
semiochemical dispensers was subsequently published in 40 CFR 180.1122)
In March of 1994, the Agency published in the Federal Register, a final rule
exempting from the requirement of a tolerance, residues of arthropod pheromones resulting
from the use of these substances in retrievably-sized polymeric matrix dispensers with an
annual application limitation of 150 grams active ingredient per acre for pest control in or
on all raw agricultural commodities (59 FR 14757, Arthropod Pheromones Tolerance
Exemption). An exemption from the requirement of a tolerance for arthropod pheromones
was subsequently published in 40 CFR 180.1124).
On August 18, 1995, a notice was published by the Agency in the Federal Register
regarding an exemption from the requirement for a food tolerance for certain lepidopteran
pheromones when used at 150 grams active ingredient per annum (60 FR 45060). An
exemption from the requirement of a tolerance for Lepidopteran pheromones was
subsequently published in 40CFR 180.1153.
The Agency also published, on February 21, 1996, in the Federal Register an
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exemption from the requirement for a food tolerance for inert materials of polymeric
dispensers for pheromones (61 PR 6550 ). An exemption from the requirement of a
tolerance for acrylate polymers and copolymers was subsequently published in 40 CFR
180.1162
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) was signed into law. EPA is embarking on an intensive process, including
consultation with registrants, States, and other interested stakeholders, to make decisions
on the new policies and procedures that will be appropriate as a result of enactment of
FQPA. This process will include a more hi depth analysis of the new safety standard and
how it should be applied to both food and non-food pesticide applications. However, in
light of the unaffected statutory deadlines with respect to reregistration, the Agency will
continue its ongoing reregistration program while it continues to determine how best to
implement FQPA.
This Reregistration Eligibility Decision Document reflects a comprehensive
assessment of all data and other available information presently before the Agency.
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III. SCIENCE ASSESSMENT
E.
Physical Chemistry Assessment
1. Product Identity and Mode of Action
Virelure is a sex attractant pheromone produced by female artichoke plume
moths to attract the males. The analytical method used to identify
(Z)-ll-hexadecenal is gas chromatography (GC).
Structural Formula:
Empirical Formula:
Molecular Weight:
CAS Registry No.:
CH3(CH2)3CH=CH(CH2)9CHO
QeHsoO
238.42
53939-28-9
The physical and chemical characteristics of the technical grade active
ingredient containing 94% virelure are summarized below:
Guideline
Reference
Number
151B-17(a)
151B-17(b)
151B-17(c)
151B-17(d)
151B-17(e)
151B-17(f)
151B-17(g)
151B-17(h)
151B-17(I)
151B-17(i)
Characteristic
Color
Physical state
Odor
Melting point
Boiling point
Density, specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition
coefficient
pH
Stability
Result
(MRE> No. 420364-01)
, Colorless
Liquid
Waxy odor
Not required, because TGAI is a liquid
120-126°C
0.849 at 20°C
Insoluble in water 0.2 ppm at 25 °C;
soluble in most organic solvents
1.2X10-3mmHg
Not applicable, because the TGAI is not soluble
in water
>1.0X104kow
Not applicable, because the TGAI is not soluble
in water
Stable under normal storage without sunlight
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2. Tolerance Exemption Food/Non-Food Use
Virelure is a pheromone sex attractant that is not applied directly to
artichokes; rather, virelure is impregnated onto polymeric dispensers and/or fibers
which are ultimately twist-tied to the stalk of an artichoke plant. This compound
belongs to the class of lepidopteran pheromones which are exempted from the
requirement of a tolerance when used at application rates of less than 150 grams of
active ingredient per acre per season in or on all raw agricultural commodities (40
CFR 180.1153). Additionally, an exemption from the requirement of a tolerance
has been established for (Z)-l 1-hexadecenal (virelure) when used as a sex attractant
on artichoke plants to control the artichoke plume moth in 40 CFR 180.1069; but
this exemption is expected to be revoked due to the existence of the exemption in
40 CFR 180.1153.
F. Human Health Assessment
1. Toxicology Assessment
Adequate mammalian toxicology data are available on virelure and will
support a Reregistration Eligibility Decision.
a. Acute Toxicity
In the evaluation of the toxicology data base for a reregistration eligibility
decision for virelure, the Agency reevaluated the primary eye irritation studies
(MRID No. 41693204 and 40757204) and primary dermal irritation study (MRID
No. 41693205) and concluded that additional precautionary label statements are
necessary to adequately mitigate these risks. Refer to Section V.
All acute mammalian toxicology studies have been submitted and adequately
satisfy the requirements as set forth in 40 CFR 158.690. The following toxicology
studies were submitted to support the registration of the active ingredient:
Guideline
Reference
Number
152B-10
152B-11
152B-12
Study
Acute Oral LD50 (rat)
Acute Dermal LD50
(rabbit)
Acute Inhalation LD,n (rat)
Results
> 5 g/kg
>2g/kg
> 5 mg/L
Category
IV
m
IV
MRID Number(s)
41693201, 00096677,
40757202
41693202, 00096677,
40757201
41693203, 40757203
-------
Guideline
Reference
Number
152B-13*
152B-14*
152B-15*
152B-16*
Study
Primary Eye Irritation
(rabbit)
Primary Dermal Irritation
(rabbit)
Dermal Sensitization
Hypersensitivity
Results
None to slight
irritation
Slight to moderate
irritation
Dermal sensitizer
All incidents must
be reported to the
Agency
Category
m
m
N/A
N/A
MEJD Number (s)
41693204, 40757204
41693205
40757206
N/A
*Not required for TGAI
b. Mutagenicity
Mutagenicity studies have been submitted and satisfy the
requirements as set forth in 40 CFR 158.690. Based on the negative results
observed in the Ames assay test, and due to the known metabolism of long-
chain aldehydes, all other mutagenicity studies were waived. The following
studies were submitted to support the initial registration of the active
ingredient (Z)-ll-hexadecenal:
Guideline
Reference
Number
152B-17
Study
Ames Assay
Results
Not mutagenic
MRID Number
00085716, 00082638
c. Additional Toxicity Information
Data from subchronic toxicology studies that evaluate compounds
similar in structure to the lepidopteran pheromones have been published in
the scientific, literature (Daughtrey et al. 1990. Subchronic toxicity
evaluation of tridecyl acetate in rats. Fundam. Appl. Toxicol. 14: 104-112).
Tridecyl acetate is structurally similar to virelure in that it is a long-chain
hydrocarbon having carbon numbers predominantly in the range of C10
through C14. irhe data and/or information submitted included compounds that
were from six- to sixteen- carbon unbranched alcohols, acetates and
aldehydes. The Agency's analysis of these compounds indicate that there
were no significant signs of toxicity. hi rats other than those expected with
longer-term exposure to high doses of a hydrocarbon. The findings were
indicative of am overall low degree of systemic toxicity following subchronic
oral administration of tridecyl acetate at doses up to 1 g/kg body weight. In
8
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addition, for most of the hematology parameters there were no statistically
significant differences between control and treated groups. Similarly, there
were no significant differences from control for the majority of measured
serum chemistry values. It should be noted that no significant acute toxicity
effects were observed with the primary alcohols, acetates or aldehydes
evaluated. Based on these test results, an exemption from tolerance (40 CFR
180.1153), low application rates (<150 g/a.i./acre/year), and nominal
potential exposure, the Agency has waived data requirements for
immunotoxicity. No additional information and/or data will be required for
virelure based on the use pattern.
2. Exposure Assessment
a. Dietary Exposure
An exemption from the requirements of a tolerance has been
established for residues of arthropod pheromones when used in retrievable-
sized polymeric matrix dispensers in or on the raw agricultural commodities
when applied to growing crops at a rate not to exceed 150 g/a.i./acre/year
in accordance with good agricultural practices (see 40 CFR § 180.1124).
The exemption was extended to broadcast applications for lepidopteran
pheromones on August 31, 1995 (60 FR 45060). The Agency was unable
to make a no-unreasonable-adverse effects finding for other arthropod
pheromone pesticides for use on food crops. However, based on the data
and/or information submitted to support the registration of straight chained
lepidopteran pheromones, the Agency concluded that the potential for such
residues is not a dietary hazard. This conclusion was based on: the lack of
Sec. 6(a)(2) incident reports; the low acute mammalian toxicity observed hi
the lepidopteran pheromones registered to date; the known metabolism of
long chain aldehydes; low application rates; and nominal human exposure
subsequent to application due to volatilization.
Further, this compound is not applied directly to the artichoke plants
nor is it taken up or metabolized by artichoke plants, rather it is incorporated
into dispensers or as a microencapsulated material. Therefore, dietary
exposure to this compound is expected to be minimal. Consequently, the
Agency has determined that, when used in accordance with good agricultural
practices, a food tolerance for the defined subset of lepidopteran
pheromones, which includes virelure, is not necessary to protect the public
health. Therefore, the Agency established an exemption from the
requirement of a tolerance for this group of active pesticidal ingredients
when used at less than 150 g/a.i./acre/year (40 CFR 180.1153)
-------
b. Occupational and Residential Exposure
Based on the use pattern, the potential for dermal, eye, and inhalation
exposures to pesticide handlers exists but is expected to be negligible.
Because of the lack of mammalian toxicity, as demonstrated in the battery
of acute toxicity studies and a related subchronic toxicity study, worker
exposure data to the active ingredient are not required. However, due to the
potential for dermal and eye irritation, the Agency will require appropriate
signal word and precautionary statements to mitigate any potential risk
discussed hi Section V. Residential exposure to virelure is not expected
based on the use pattern.
c. Residential, School, and Daycare Exposure
No indoor residential, school, or daycare uses currently appear on
the label. The potential of significant exposure to children other than from
dietary exposure is anticipated to be considerably less than that used in
exposing experimental animals in tests. While accidental nondietary
exposure to children could occur, any resulting health risks are expected to
be minimal based on low mammalian toxicity, nominal exposure due to high
volatility of the compound, and a history of safe use.
3. Human Risk Assessment
The potential risks to humans are considered negligible based on the
lack of significant toxicological concerns, as demonstrated in the Agency's
evaluation of the mammalian toxicology studies, low application rates, low
exposure subsequent to application due to volatilization, and known
metabolism of long-chain aldehydes. In the event that the technology for
manufacturing and/or synthesizing the compound and/or use pattern changes
such as to increase the likelihood of exposure, the Agency will continue to
evaluate the meed for additional toxicology testing on the technical grade
material.
4. Drinking Water and Risk Characterization
No significant exposure is expected from an accumulation of virelure in the
aquatic environment due to the application method (dispensers) and precautionary
label language; "Do not apply directly to water or wetlands." Based on the
available studies used in EPA's assessment of environmental risk, the Agency does
not anticipate exposure to residues of virelure in drinking water. Also, the
aforementioned label, language mitigates against exposure through drinking water.
10
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5.
Acute and Chronic Dietary Risks for Sensitive Subpopulations
Particularly Infants and Children
The Agency has concluded that the potential for pheromone residues is not
a dietary hazard to the general population, including infants and children. This
decision was based on: low acute and subchronic mammalian toxicity, known
metabolism of similar compounds, and the history of safe use of similar lepidopteran
pheromones. Also, for food uses of pheromones, the toxicity and residue data have
allowed for the conclusion that an exemption from the requirement of a tolerance is
appropriate and adequate to protect human health, including that of infants and
children.
6. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation
(Z)-ll-hexadecenal (virelure) technical pheromones are synthetic compounds
which mimic naturally occurring substances of insect origin with a non-toxic mode
of action to target pests. The low oral, dermal and inhalation toxicity is
demonstrated by the data summarized above. Based on this information, the Agency
has concluded that aggregate exposure to such lepidopteran pheromones as (Z)-ll-
hexadecenal technical pheromones over a lifetime will not pose appreciable risks to
human health. Moreover, the toxicity and exposure data are sufficiently complete
to adequately address the potential for additional sensitivity of infants and children
to residues of virelure. The Agency concludes that there is reasonable certainty of
no harm to infants and children from aggregate exposure to residues of (Z)-ll-
hexadecenal technical pheromone.
7.
Cumulative Effects
The Agency has considered available information on the cumulative effects
of such residues and other substances that might have a common mechanism of
toxicity. These considerations included the cumulative effects on infants and
children of such residues and other substances with a common mechanism of
toxicity. Since there is no significant toxicity for Lepidopteran active pheromones,
the Agency concluded that there won't be any cumulative effects.
G. Environmental Assessment
Virelure meets current eligibility requirements for reregistration. There are no
outstanding data gaps. There is sufficient background and intended use information
regarding this particular class of lepidopteran pheromones to satisfy adverse risk concerns
to nontarget organisms.
11
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1. Ecological Toxicity Data
All of the ecological effects data requirements for virelure have been
adequately fulfilled. These data indicate that virelure is not likely to cause adverse
effects in nontarget avian, fish, plant, and insect species.
Since virelure has been determined to be highly toxic to aquatic invertebrates
(Daphnia- MRID No. 41693207) and may form an oily surface film on water
(MRID No. 41693206), the Agency has concluded that special precautionary label
language will be required to mitigate risks to aquatic invertebrate species. Refer to
Section V.
The following ecological data on nontarget organisms was submitted to
support the registration of virelure:
Guideline No.
154B-6
154B-7
154B-8
154B-9
154B-10
154B-11
Study
Avian acute oral
Avian acute
dietary
Fish Toxicity-
Rainbow Trout
Invertebrate
toxicity
Nontarget Plants
Nontarget Insects
Results
Virelure did not demonstrate toxicity when administered orally to
bobwhite quail (Colinus virginianus) under reported study
conditions
Virelure was practically nontoxic to bobwhite quail (Colinus
virginianus) when administered in the diet for five days
- The virelure is practically nontoxic to rainbow trout (Salmo
gairdneri) under reported study conditions, at and above its
solubility limit of 0.2 mg/L. Beyond the solubility limit, the
compound forms an oily surface film that may likely affect
organisms that utilize the water surface.
Virelure was determined highly toxic to Daphnia under
conditions of the reported flow-through study. The LC50 was
based on nominal concentrations and, as a result, is probably
invsJid. The actual LC50 may have been between 0.58 mg/L and
the 0.20 mg/L solubility limit of the test compound. Also, the
pheromone forms an oily film potentially capable of affecting
interfacial tensions at the water surface upon which various
arachnids and insects depend.
Based on the intended use of the virelure, data or studies for non-
target terrestrial or aquatic plants are not required at this time for
reregistration.
Virelure's biological activity is highly specific to the artichoke
plume moth and as such is considered practically nontoxic to
other insects. Accordingly, no data or studies concerning
nontarget insects are required at this time for reregistration.
MRID
417181-01
417181-02
416932-06
416932-07
12
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2.
Environmental Fate
Environmental fate studies are not required for biochemical pesticides unless
adverse effects on nontarget species are observed as a result of acute testing for
ecological effects (Tier I). No adverse effects are suggested by the data as described
hi the table above. Because no adverse effects were observed hi Tier I testing on fish
and wildlife, there are no Environmental Fate Data Requirements for the
reregistration of virelure.
3. Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Terrestrial Animals
Because no adverse effects were observed hi Tier I testing on
wildlife, there is little to no risk of adverse effects on terrestrial annuals.
Virelure is impregnated hi a solid matrix dispenser and is slowly released by
volatilization, limiting its transport and resultant exposure. This dispensing
system is generally accepted as posing minimal to no exposure risk to birds
or terrestrial mammals.
b. Exposure and Risk to Nontarget Aquatic Animals
Virelure was determined highly toxic to Daphnia and practically
nontoxic to freshwater fish. Based on the intended use of the virelure,
exposure to aquatic animals is not expected. Moreover it is the Agency's
opinion that risks to aquatic species will be adequately mitigated by special
precautionary product labeling. Refer to Section V.
c. Exposure and Risk to Nontarget Plants
Based on the intended use of virelure, studies for nontarget terrestrial
or aquatic plants are not required for reregistration at this tune.
d. Exposure and Risk to Endangered Species
Virelure has a nontoxic mode of action specific to the artichoke
plume moth. There are no endangered species concerns in an agricultural
(intensive) system. Furthermore, there is limited national acreage affected,
as artichokes are a minor crop.
13
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
H. Determination of EligibiUty
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing virelure active ingredients. The Agency has
completed its review of these generic data, and has determined that the data are sufficient
to support reregistration of products containing virelure for non-food use. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of virelure, and lists me 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 virelure and to determine mat virelure can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that products containing virelure as the active ingredients are eligible for reregistration for
non-food use. The reregistration of particular products is addressed in Section V of this
document.
The Agency made its reregistration eligibility determination based upon the data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified hi Appendix
B. Although the Agency has found that all uses of virelure 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
virelure, if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
1.
Eligibility Decision
Based on the reviews of the generic data for the active ingredients in
virelure, the Agency has sufficient information on the health effects of virelure and
on its potential for causing adverse effects in fish and wildlife and the environment.
The Agency has determined that products containing virelure, when 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 mat products containing virelure for non-food use are eligible
for reregistration.
2. Eligible and Ineligible Uses
14
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The Agency has determined that virelure, when used as a sex attractant on
artichoke plants to control the artichoke plume moth, is eligible for reregistration.
No other uses of virelure are eligible for reregistration.
I. Regulatory Position
The following is a summary of the regulatory positions and rationales for virelure.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Food Quality Protection Act Considerations
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) (Public
Law 104-170) was signed into law. FQPA amends both the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA
amendments went into effect immediately. Among other things, FQPA amended the
FFDCA by establishing a new safety standard for the establishment of tolerances.
The FQPA did not, however, amend any of the existing reregistration deadlines hi
section 4.
In determining whether a tolerance meets the new safety standard, section
408(b)(2)(C) directs EPA to consider information concerning the exposure of infants
and children to pesticides in food, available information concerning the
susceptibility of infants and children to pesticide residues in food, and available
information concerning cumulative effects on infants and children of such residues
and other substances that have a common mechanism of toxicity. Section
408(b)(2)(D) establishes factors that the Agency must consider in determining
whether the safety standard is met; these factors include the consideration of
available information on the cumulative effects of the pesticide for which a tolerance
is sought as well as other substances that have a common mechanism of toxicity and
consideration of available information on the aggregate exposure levels of the
population and of major subgroups of the population to the pesticide and related
• substances.
EPA is embarking on an intensive process, including consultation with
• registrants, States, and other interested stakeholders, to make decisions on the new
policies and procedures that will be appropriate as a result of enactment of FQPA.
This process will include a more hi depth analysis of the new safety standard and
how it should be applied to both food and non-food pesticide applications.
However, hi light of the unaffected statutory deadlines with respect to reregistration,
the Agency will continue its ongoing reregistration program while it continues to
determine how best to implement FQPA.
15
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In deciding to continue to make reregistration determinations during the
early stages of FQPA implementation, EPA recognizes that it will be necessary to
make decisions relating to FQPA before the implementation process is complete.
In making these early, case-by-case decisions, EPA does not intend to set broad
precedents for the application of FQPA to its regulatory determinations. Rather,
these early decisions will be made on a case-by-case basis and will not bind EPA as
it proceeds with further policy development and any rule-making that may be
required.
If EPA determines, as a result of this later implementation process, that any
of the determinations described in this RED are no longer appropriate, the Agency
will consider itself free to pursue whatever action may be appropriate, including but
not limited to reconsideration of any portion of this RED.
2.
Tolerance Reassessment
Lepidopteran pheromones are exempt from the requirements of a tolerance
under 40 CFR 180.1153.
3. Endangered Species Statement
Currently, the; Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse impacts
on endangered and threatened species and to implement mitigation measures that
will eliminate the adverse impacts. The program would require use restrictions to
protect endangered and threatened species at the county level. Consultations with
the Fish and Wildlife Service may be necessary to assess risks to newly listed
species or from proposed new uses. In the future, the Agency plans to publish a
description of the Endangered Species Program in the Federal Register and have
available voluntary county-specific bulletins. Because the Agency is taking this
approach for protecting endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any requirements for product
use modifications will occur in the future under the Endangered Species Protection
Program.
4. Labeling Rationale
The Agency has reexamined the toxicological database for virelure and
concluded that the current Signal Word (Caution) and Statement of Practical
Treatment are appropriate. However, due to the primary eye and dermal irritation
response, the Agency will require a revised Precautionary Statement to mitigate this
risk.
16
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The Agency has also reexamined the ecological database for virelure and
concluded the since virelure is toxic to Daphnia and forms an oily film on the
surface of water that is capable of adversely affecting certain aquatic organisms,
label language will be required to prevent application to water, effluent discharges
to water bodies, or contamination of water during equipment cleaning. Refer to
Section V. v
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.
J. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of virelure for the above
eligible uses has been reviewed and determined to be substantially complete.
According to guideline 151B-15, an updated and current CSF including
Certification of Limits must be submitted to the Agency.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an insecticide contained within a solid matrix
dispenser."
An MP registrant may, at his/her discretion, add one of the following statements to
an MP label under
"Directions for Use" to permit the reformulation of the product for
a specific use or all additional uses supported by a formulator or user
group:
(a) "This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
17
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(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Manufacturing use product labels must also contain the following NPDES
statement: "Do not discharge effluent containing this active ingredient into lakes,
streams, ponds, estuaries, oceans, or public waters unless this product is specifically
identified and addressed hi an NPDES permit. Do not discharge effluent containing
this product to sewer systems without previously notifying the sewage treatment
plant authority. For guidance contact your State Water Board or Regional Office
of the EPA."
K. 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.
According to guideline 151B-15, an updated and current CSF including
Certification of Limits must be submitted to the Agency.
2. Labeling Requirements for End-Use Products
Precautionary Statement
To mitigate the risk of eye and skin irritation, the following statement must
appear under the Precautionary Statement: "Causes slight eye and dermal irritation.
Avoid contact with eyes, skin, or clothing. Wash thoroughly with soap and water
after handling."
Environmental Hazards
To mitigate exposures to freshwater invertebrates, precautionary label
language for products containing virelure must include the following statement
under the "Environmental Hazards" heading: "This product is highly toxic to
aquatic invertebrates. Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high water mark. Do not
contaminate water by cleaning of equipment or disposal of equipment washwaters."
Worker Protection Standard
18
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According to Pesticide Regulation (PR) Notice 93-7, "Labeling Revision
Required by the Worker Protection Standard (WPS)," WPS does not apply to
attractants used in insect traps. Since virelure is expected to be used in a solid
matrix device, it is exempt from WPS labeling requirements.
Storage and Disposal
In conformity with virelure's use, labels must read "Do not contaminate
water, food, or feed by storage or disposal."
19
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VI. APPENDICES
20
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21
-------
APPENDIX A. Use Pattern Subject To Reregistration
The manufacturing-use product (AgriSense® Technical Pheromone Z-ll) is registered to
be used only for manufacturing or formulating registered biochemical pesticide products or devices.
The end-use product (APM-ROPE™) is currently labeled to contain 7.04% (Z)-ll-hexadecenal.
The APM-ROPE™ is to be applied as a twist-tie dispenser loosely attached around the inside of the
stalk of the artichoke plant either immediately before moths emerge or after an insecticide treatment
to eradicate existing moth infestations at a rate of at least 400 per acre.
22
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r
23
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APPENDIX B. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Virelure
24
-------
25
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case virelure covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to virelure in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J.Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been assigned.
Refer to the Bibliography appendix for a complete citation of the study.
26
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MRID
BIBLIOGRAPHY
CITATION
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Heliothis—2 Component... in the Ames Salmonella/Microsome
Plate Test: LBI Project No. 20988; Genetics Assay No. 5194.
(Unpublished study received Feb 13, 1981 under 36638-EX-4;
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Albany International Co., Needham Heights, Mass.;
CDL:()99916-E)
Jagannath, D.R.; Goode, S. (1980) Mutagenicity Evaluation of
Heliothis-2 Component: 94.1% Z-11-hexadecenal, 5.9% Z-9-
tetradecenal plus 1 % Banox 20BA hi the Ames
Sahnonella/Microsome Plate Test: LBI Project No. 20988. Final
rept. (Unpublished study received Aug 7, 1981 under 36638-10;
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Albany International Co., Needham Heights, Mass.;
CDL:245801-G)
Herculite Products, Incorporated. (1982). Chemical Study of
Hercon (R) Disrupt (R) /Artichoke Plume Moth. (Compilation;
unpublished study received March 17, 1982 under 8730-34; CDL:
070717-A.
Hathom, S. (1988) (Z)-ll-Hexadecenal (APM-ROPE): Acute
Dermal Toxicity Studies in Rats. Unpublished study prepared by
Hazleton Labs America, Inc. 20 p.
Hathom, S. (1988) (Z)-ll-Hexadecenal (APM-ROPE): Acute Oral
Toxicity Studies in Rats. Unpublished study prepared by Hazleton
Labs America, Inc. 13 p.
Hathom, S. (1988) (Z)-ll-Hexadecenal (APM-ROPE): Acute
Inhalation Toxicity Studies in Rats — LC50 (4 Hour Exposure).
Unpublished study prepared by Hazleton Labs America, Inc. 51 p.
Hathoirn, S. (1988) (Z)-ll-Hexadecenal (APM-ROPE): Primary
Eye Irritation Study in Rabbits. Unpublished study prepared by
Hazleton Labs America, Inc. 21 p.
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Unpublished study prepared by Hazleton Labs America, Inc. 31 p.
Glaza, S. (1989) Acute Dermal Toxicity Study of Z-ll
Hexadecenal in Rabbits: Final Report: Lab Project Number: HLA
81102697. Unpublished study prepared by Hazleton Labs
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Pheromone Z-ll in the Rat: Final Report: Lab Project Number:
652-226. Unpublished study prepared by Hazleton Labs America,
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Glaza, S. (1990) Primary Eye Irritation Study of Z-ll-
Hexadecenal in Rabbits: Final Report: Lab Project Number: HLA
81102698. Unpublished study prepared by Hazleton Labs
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Hexadecenal hi Rabbits: Final Report: Lab Project Number: HLA
81102699. Unpublished study prepared by Hazleton Labs
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Acute Oral Toxicity Study with the Bobwhite: Final Report: Lab
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_
31
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INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Laura Sallmen Smith at (703) 308-8716.
All responses to this Notice for the generic data requirements should be submitted to:
Robyn Rose, Entomologist
Biopesticides and Pollution Prevention Division (7511C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Virelure
32
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The following is a list of available documents for virelure that my further assist you in
responding to this Reregistration Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format:
1.
Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special Review
and Reregistration Information System at 703-308-7224. They also are available
on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or using ftp on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV., or
contact Robyn Rose at (703)-308-9581.
PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for virelure.
The following documents are part of the Administrative Record for virelure and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1.
The Label Review Manual.
2. EPA Acceptance Criteria
33
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