United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-R-95-029
September, 1995
FACTS
Nuranone
Pesticide All' pesticides sold or used in the United States must be registered by
Reregistration 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 years ago 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 imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision Document, or RED.
This fact sheet summarizes the information in the RED for nuranone.
Use Profile
Nuranone is the sex pheromone of the female Japanese beetle, Popillia
japonica (Newman), and is used as a lure for male Japanese beetles in
conjunction with a floral lure to attract female Japanese beetles.
Terrestrial Non-Food Crop:
n Agricultural Crops/Soils and Vegetables
n Orchards and Deciduous Fruit Trees
n Grapes
Terrestrial Non-Food + Outdoor Residential:
Q Ornamental and/or Shade Trees
n Ornamental Herbaceous Plants
n Ornamental Nonflowering Plants
n Ornamental Woody Shrubs and Vines
Formulation is as impregnated material, 1-1.5 mg nuranone/dispenser.
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Equipment: package applicator (trap)
Summer (when foliage is present)
Usage
Less than 500 pounds used annually.
Use limitations: None.
Methods and Maximum Rates of Application:
As an attractant, package traps are placed to allow a
' maximum application rate of 3.53 x 10'5 pounds active ingredient per acre or
2.204 x 10'7 pounds active ingredient per one foot interval.
Regulatory Nuranone was first registered hi the United States hi 1979. A Data
History Call-In was issued hi September, 1993. There are currently five nuranone
products with an active registration. Because nuranone is an insect
pheromone, and is used hi a trap, the Agency granted reduced data
requirements appropriate for a biochemical pesticide, for the original
registration. Data on product chemistry and toxicology were received hi
• response to a Data Call-in. The Agency has since waived the requirment
for the remaining generic studies.
Human Health Toxicity
Assessment Adequate mammalian toxicology data on nuranone are available for
uses of nuranone hi a trap, and will support a Reregistration Eligibility
Decision (RED).
Dietary Exposure
Since there are no food uses of nuranone, dietary exposure is not
expected.
Occupational and Residential Exposure
Human exposure is limited to the inhalation route since the product is
only available hi the controlled-release dispenser. Exposure will be limited
if label instructions are followed. The release rate from the trap is
comparable to the release from the female Japanese beetle hi the
environment at peak pest infestations. Based on low exposure and lack of
significant lexicological concerns by the inhalation route, occupational
exposure studies are not triggered. The studies submitted for inhalation
toxicology on the technical grade active ingredient used a dosage that.
resulted in a rating of Toxicology Category HI, Based on a release rate of
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0.005 mg/hr from the end-use product, the Agency has placed inhalation
toxicity in Toxicology Category IV (>20 mg/L).
Human Risk Assessment
Applicator Exposure
The only route of exposure is inhalation, but risk characterization is
inappropriate at this time because of the low exposure, the categorization of
inhalation risk as Toxicology Category IV, and the lack of incident reports
since 1979. Therefore no additional information and/or toxicology data are
required.
Environmental
Assessment
Ecological Toxicity Data
Effects to nontarget organisms are not expected because of the specific
mode of action of nuranone as a Japanese beetle pheromone. Because
nuranone is enclosed in a plastic dispenser within the trap, no exposure to
birds, fish, or aquatic organisms is expected. Pheromones in traps are
exempted from FIFRA regulation under 40 CFR §152.25 (b), and therefore
the data requirements for ecological toxicity testing have been waived..
Environmental Fate
Environmental fate Tier n studies for biochemicals are not imposed
unless adverse effects are observed hi Tier I Environmental Expression
testing with fish and wildlife. The Agency will not impose any
environmental fate requirements for reregistration of the current registered
products containing nuranone in dispensers.
Exposure and Risk Characterization
Effects to nontarget organisms are not expected because nuranone is
specific only for Japanese beetles. Nuranone has a non-toxic mode of
action, and with lack of exposure to non-target organisms, no unreasonable
adverse effects are expected.
Additional Data The generic data base supporting the reregistration of nuranone 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
Changes Required
The labels of all registered pesticide products containing nuranone
must comply with EPA's current pesticide labeling requirements. In
addition:
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Regulatory
Conclusion
For More
Information
Use Sites - Those labels that have no use sites specified are only
conditionally eligible for reregistration until new labels are submitted with
use sites listed.
Application Rate - All labels must give a specific maximum application
rate.
Non-Food Use - In conformity with nuranone's non-food use, labels should .
read, "Do not contaminate water, food, or feed by storage or disposal."
Based on the reviews of the generic data for the active ingredient
nuranone, the Agency has sufficient information on the health effects of
nuranone and on its potential for causing adverse effects in fish and wildlife
and the environment. The Agency has determined that nuranone products,
labeled and used as specified hi this Reregistration Eligibility Decision, will
not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, the Agency concludes that for products containing
nuranone in traps, all uses are eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision Document (RED) for nuranone during a 60-day time period, as
announced hi a Notice of Availability published hi the Federal Register. To
obtain a copy of the RED or to submit written comments, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the nuranone, RED 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 the nuranone RED or about EPA's
pesticide reregistration program, and for information about reregistration of
individual products containing this active ingredient, please contact the
Biopesticides and Pollution Prevention Division (7501W), 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
reregistration eligibility review and decisions on the pesticide chemical case nuranone which
includes the active ingredient nuranone. The enclosed Reregistratipn 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 Biopesticides and Pollution Prevention Division representative
Anne R. Leslie at (703) 308-8727. Address any questions on required generic data to the
Biopesticides and Pollution Prevention Division representative, Anne R. Leslie.
Sincerely yours,
'Janet Andersen, Director
Biopesticides and Pollution
Prevention Division
Enclosures
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail;
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7501W)
EPA, 401 M St. S.W.
Washington,.D.C. 20460^0001
By express;
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7501W)
•Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Nuranone
LISTD
CASE 4113
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
BIOPESTICIDES AND POLLUTION PREVENTION DIVISION
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TABLE OF CONTENTS
NURANONE REREGISTRATION ELIGIBILITY DECISION TEAM . i
EXECUTIVE SUMMARY . . iv
I. INTRODUCTION . i
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile , ; 2
C. Estimated Usage of Pesticide 4
D. Regulatory History '. . 4
m. SCIENCE ASSESSMENT 5
A. Physical and Chemical Properties Assessment 5
B. Human Risk Assessment ; 6
1. Toxicology Assessment . . 6
a. Acute Toxicity 6
b. Mutagenieity 7
2. Exposure Assessment . . . . 7
a. Dietary Exposure 7
b. Occupational and Residential Exposure 7
3. Risk Assessment :........ 8
C. Environmental Risk Assessment g
1. Ecological Toxicity Data . .8
2. Environmental Fate Data 8
IV. RISK MANAGEMENT AND REREGISTRATION DECISION . 9
A. Determination of Eligibility . . . 9
1. Eligibility Decision 9
2. Eligible and Ineligible Uses : . 10
B. Regulatory Position 10
1. Tolerance Reassessment '....'.. 10
2. Endangered Species Statement 10
3. Labeling Rationale . . . . 11
V. ACTIONS REQUIRED OF REGISTRANTS 12
A. • Manufacturing-Use Products .... 12
1. Additional Generic Data Requirements 12
2. Labeling Requirements for Manufacturing-Use Products 13
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B. End-Use Products 13
1. Additional Product-Specific Data Requirements 13
2. Labeling Requirements for End-Use Products 13
3. Existing Stocks 14
VI. APPENDICES 16
APPENDIX A. Table of Use Patterns Subject to Reregistration 17
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 20
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Nuranone -. • 23
APPENDIX D. List of Available Related Documents 27
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NURANONE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biopesticides and Pollution Prevention Division
PhilHutton
Anne Leslie
Tom McClintock
Sheryl K. Reilly
Robert I. Rose
Roy Sjoblad
Freshteh Toghrol
Robert Torla
Biological and Economic Analysis Division
John DuPuy
Eric Maurer
Shiva Sastry
Health Effects Division
Sue Hummel
John Abbotts
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
aj. 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 not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
OLC 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
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.
LD,,, Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act
jjg/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
NOEL No Observed Effect Level
LD.
'so
n
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOAEL No Observed Adverse Effect Level
OP • Organophosphate
OPP . Office of Pesticide Programs .
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PKN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC RedBlbodCell.
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24© of EIERA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a'column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP .Wettable Powder
WPS Worker Protection Standard
ill
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as the "Agency" or
"EPA") has completed its reregistration assessment of the available information on the pesticide
active ingredient nuranone. Nuranone is the sex pheromone of the female Japanese beetle,
Popilliajaponica (Newman), and is used as a lure for male Japanese beetles in conjunction with
a floral lure to attract female Japanese beetles.
The Agency considers that nuranone, when used around a crop is a non-food use because
it is placed in traps rather than applied to the crop. The Agency has determined that the uses of
nuranone in dispensers, as currently registered, will not cause unreasonable .risk to humans or the
environment, and these uses are eligible for reregistration. The Agency is requiring a new or
revised Confidential Statement of Formula (CSF) and an amended label for each product, but
additional generic or specific product chemistry studies are not required for the technical grade
active ingredient (TGAI).
Data requested in the September, 1993 Data Call-In for nuranone includes product
chemistry, toxicology, and some ecological effects data. The Agency has received data in ah1
categories except for lie ecological effects studies.
Prior to reregistration of the end-use products containing nuranone, the specific data,
revised Confidential Statements of Formula and revised labels are to be submitted within
eight months of the issuance of this document. These data include product chemistry for
each registration. After review of these data and any revised labels and upon finding them
acceptable in accordance with Section 3(c)(5) of Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), the Agency will reregister a product. Those products which contain other active
ingredients will be eligible for reregistration only if the other active ingredients are
registered.
IV
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I. INTRODUCTION
In 1988, the Federal Insecticide., Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the feregistration of products with active ingredients registered prior to November
1,1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of nuranone. The document consists of six sections. Section I is the
introduction. Section II describes nuranone, its uses, data requirements and regulatory history.
Section HI discusses lie human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for nuranone. Section V discusses
the reregistration requirements for nuranone. 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:
Common Name:
nuranone
Chemical Name:
(R,Z>5-(l-decenyl)dihydro-2(3H)-furanone
Chemical Family:
furanone
• CAS Registry Number: 64726-91-6
Case No.:
4113
OPP Chemical Code: 116501
Empirical Formula: C14H24O2
Trade and Other Names: JAPONILURE, Furanone
Basic Manufacturer:
Nitto Denko, Osaka, Japan;
ACE, Alleritown, PA
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. This information is current as of 6/16/95. A detailed
table of these uses of nuranone is in Appendix A.
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Type of Pesticide for Single Active Ingredient:
BIOCHEMICAL (PHEROMONE, ATTRACTANT)
Additional Type of Pesticide for Multiple Active Ingredient:
FLORAL LURE
Mode of Action:
Attracts adult beetles to a trap (a bag); these beetles can then be killed by
physical or mechanical means. The traps are multiple active ingredient products
that contain a floral lure in a separate dispenser.
Use sites:
TERRESTRIAL NON-FOOD CROP:
Registrants need to specifiy type of orchards, fruit trees, vegetables and soils.
* AGRICULTURAL CROPS/SOILS AND VEGETABLES
* ORCHARDS AND DECIDUOUS FRUIT TREES
* GRAPES
TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
* ORNAMENTAL AND/OR SHADE TREES
* ORNAMENTAL HERBACEOUS PLANTS
* ORNAMENTAL NGNFLOWERING PLANTS .
* ORNAMENTAL WOODY SHRUBS AND VINES
Target Pests for Single Active Ingredient:
Popillia japonica (Newman), Japanese beetle
Types/Formulations Registered:
END USE PRODUCT
IMPREGNATED MATERIAL
0.13 to 0.47% a.i. per dispenser
Types of Treatment:
Attractant treatment (beetles are attracted into trap
where they may die or be killed mechanically.)
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Equipment: Package applicator (trap)
Timing: Summer (when foliage is present)
Use Limitations: None.
Methods and Maximum Rates of Application:
As an attractant, package traps are placed to allow a maximum application
rate of 3.53 x 10'5 pounds active ingredient per acre or 2.204 x 10'7 pounds active
ingredient per one foot interval. See Appendix A for other rates.
C. Estimated Usage of Pesticide
Nuranone is registered for grapes, all fruits and vegetables, and orchards,
as well as ornamental trees, shrubs and herbaceous plants. Use of this product on
agricultural or food crops is considered a non-food use because the product is
placed in traps rather than applied to the crop. A review of in-house proprietary
and non-proprietary usage data from 1990-1992 confirms that nuranone is not used
directly on any of the food crop sites.
The Agency examined available data to support in-house estimates that the
usage of nuranone is not likely to exceed 500 Ibs. a.i. per year.
D. Regulatory History ,
Nuranonewas registered in the United States in 1979 for use as an insect attractant
for Japanese beetles.
There are currently five nuranone products with an active registration. All
products contain in one dispenser, technical grade nuranone, (R,Z)-5-(l-Decenyl)dihydro-
2-(3H)-furanone, and in a separate dispenser, a floral lure consisting of varying amounts
of eugenol, geraniol, and 2-phenylethyl propionate.
Because nuranone is an insect pheromone, and is used in a trap, the Agency
granted reduced data requirements appropriate for a biochemical pesticide, for the original
registration. A Data Call-In was issued in September, 1993 for nuranone requiring
additional product chemistry, toxicology, and ecological effects data to assess the
potential for toxicity as a result of exposure to this compound.
Data on product chemistry and toxicology were received. The Agency has since
waived the requirement for the remaining generic studies.
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This Reregistration Eligibility Decision reflects an assessment of all data and other
available information before the Agency.
ffl. SCIENCE ASSESSMENT
A. Physical and Chemical Properties Assessment
Nuranone, R,A-5(l-decenyl)-dihydro-2(3H)-furanone is a pheromone, a sex
attractant naturally produced by the female Japanese beetle to attract the male. The
structural formula is:
H.
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
Nuranone
C14H24O2
224
64726-91-6
116501
Below are physical chemistry characteristics of technical nuranone:
-" 'Gtitf^ateT/
' IfamSer
151B-17(a)
151B-17(b)
151B-17®
151B-17(d)
151B-17(e)
151B-17(f)
V f f f ^ f f •.""
Color
Physical State
Odor
Melting Point
Boiling Point
Density
-; -;;-ri^r' ^- :
_. ff f ff fff ffff f f t
Clear (colorless)
Oily liquid
No characteristic odor;
Slightly organic odor .
Not applicable
135-136 °C ©0.25-0.30 mmHg;
1 10 °C@ 0.005 mmHg
0.904 g/L
0.9387 g/L @ 25°C
' MM* ^.
'
425071-03
425071-03
425071-03
CA416144-01
425071-01-C
416144-03
416144-03
425010-02
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%'* "* v^'??1
Gwdeira&Bsferd&tpe \ V\
Naaibe* » ,"?»
151B-17(g)
151B-17(h)
1516-17(1)
151B-17Q)
151B-17(k)
151B-17(1)
151B-17(o)
151B-17 ':-
Insoluble in water; soluble in
aliphatic and aromatic
hydrocarbons.
Solubility in water @
25°C<0.01%
Very low
Not applicable
7.6
Stable to heat and light
FlashPoint >200°C
Stable to heat (at 50°C for 30
days); and light (48 hours in sun)
Not Corrosive
1.00
jm>& /
,
416144-03
425010-02
416144-03
416144-03
425010-02-
416144-03
416144-03;
Ca416144-01
4-25010-02
416144-03
416144-03
B. Human Risk Assessment
1. Toxicology Assessment
Adequate mammalian toxicology data on nuranone are available for uses
of nuranone in a trap, and will support a Reregistration Eligibility Decision
(RED).
a. Acute Toxicity
'Certain acute mammalian toxicity studies are required under 40
CFR 158.690. The following table summarizes the data requirements and
data received (studies were performed on the TGAI):
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;• , ' f'.
Guideline ?%<
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
s* \^8tofy, -I
Acute oral toxicity
(rat)
Acute dermal toxicity
(rabbit)
Acute Inhalation
(rat)
Primary eye irritation
Primary dermal irritation
Hypersensitivity incidents
Kes«M;
Data waiver
request
Data waiver
request
> 1.35 mg/L
aerosol to rats
Data waiver
request
Data waiver
request
Will report
: t&fegniry "
(Waived)
(Waived)
m
(Waived)
(Waived)
To be reported
$dp»&^ ' , ;
N/A
N/A
50879, 50880
N/A
N/A
N/A
b. Mutagenicity
Guideline; No. 152B-17, Mutagenicity (Ames Assay). A study,
MRID # 50881 was submitted but not reviewed. The study reported
negative results. The data requirement was waived.
c. Incident Data
No incidents have been reported since the initial registration in
1979. .
2. Exposure Assessment
a. Dietary Exposure
Since there are no food uses of nuranone, dietary exposure is not
expected.
b. Occupational and Residential Exposure
Human exposure is limited to the inhalation route since-the product
is only available hi the controlled-release dispenser. Exposure will be
limited if label instructions are followed. The release rate from the trap
(0.0005 mg/hr/dispenser) is comparable to the release from the female
Japanese beetle in the environment at peak pest infestations. Based on low
exposure and lack of significant toxicological concerns by the inhalation
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route, occupational exposure studies are not triggered. The studies
submitted for inhalation toxicology on the technical grade active ingredient
(MRID# 50879 and 50880) used a dosage that resulted in a rating of
Toxicology Category IE. Based on a release rate of 0.005mg/hr from the
end-use product, the Agency has placed inhalation toxicity hi Toxicology
Category IV ( > 20 mg/L).
3. Risk Assessment
a. Dietary Risk
Nuranone has no food uses and therefore a dietary risk is not
expected.
b. Additional Risk Characterization
The only route of exposure is inhalation, but risk characterization
is inappropriate at this time because of the low exposure, the categorization
of inhalation risk as Toxicology Category IV, and the lack of incident
reports since 1979. Therefore no additional information and/or toxicology
data are required. In the event that the technology for manufacturing
and/or synthesizing the compound and/or the use pattern changes such as
to increase the likelihood of exposure, the Agency may reevaluate the need
for toxicology testing on the technical grade material.
C. Environmental Risk Assessment
1. Ecological Toxicity Data
Effects to nontarget organisms are not expected because of the specific
mode of action of nuranone as a Japanese beetle pheromone. Because nuranone
is enclosed in a plastic dispenser within the trap, no exposure to birds, fish, or
aquatic organisms is expected. Pheromones in traps are exempted from FIFRA
regulation under 40 CFR §152.25 (b), and therefore the data requirements for
ecological toxicity testing have been waived.
2.
Environmental Fate Data
Environmental fate Tier n studies for biochemicals are not imposed unless
adverse effects are observed in Tier I Environmental Expression testing with fish
and wildlife. The Agency will not impose any environmental fate requirements for
reregistration of the current registered products containing nuranone in dispensers.
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3. Environmental Risk Assessment
No more data are required because nuranone is specific only for Japanese
beetles. It has a non-toxic mode of action, and with a lack of exposure to non-
target organisms, no unreasonable adverse effects are expected.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
. ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing nuranone active ingredients. The Agency
has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing nuranone. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of nuranone, 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 nuranone and to determine that nuranone can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing nuranone as the active ingredients are eligible for
reregistration. The reregistration of particular products is addressed in Section V of this
document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of nuranone 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 nuranone, 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
nuranone, the Agency has sufficient information on the health effects of nuranone
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that nuranone products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose
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unreasonable risks or adverse effects to humans or the environment. Therefore,
the Agency concludes that products containing nuranone hi traps, all uses are
eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of nuranone in traps are eligible
for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
nuranone. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
1. Tolerance Reassessment
The Agency has determined that nuranone, as a pheromone in a trap, is a
non-food use, and therefore is exempt from tolerance requirements.
2. Endangered Species Statement
The Agency has no concerns about the exposure of threatened and
endangered species to nuranone because it is specific to Japanese beetles and
enclosed in a trap.
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program hi the Federal Register hi the future. 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.
10
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3. Labeling Rationale
a. Worker Protection Standard
Any Product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with
the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS)", and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7", which reflect the requirements of EPA's labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED,, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed in these notices.
After April 21, 1994 Except-as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by the primary registrant or
any supplementally registered distributor,
After October 23, 1995, except as otherwise provided hi PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person,
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other applicable
notices.
b. Precautionary Labeling
The Agency has reexamined the toxicological data base for nuranone and
concluded that the current precautionary labeling (i.e. Signal Word, Statement of
Practical Treatment, and other label statements associated with mitigating risks)
adequately mitigate the risks associated with the use of this pheromone.
c. Application Rate
In order to remain hi compliance with FIFRA, it is the Agency's position
that the labeling of the currently registered pesticide product containing nuranone
must comply with the Agency's current pesticide labeling requirements. The
Agency has determined that labeling must be changed to give a specific maximum
application rate and specifUTdirections for replacement. Application directions
such as:
11
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"TRAP SHOULD BE SET OUT AT FIRST SIGHTING OF JAPANESE
BEETLES. PLACE TRAPS DOWNWIND OF PLANTINGS. HANG
TRAPS IN SUNNY AREAS WITH FINS 3-5 FEET ABOVE THE
GROUND. PLACE TRAPS 20-30 FEET FROM PLANTINGS AS THEY
WILL ATTRACT BEETLES TO THE FOLIAGE IF PLACED CLOSER.
SET TRAPS 10 FEET APART FOR HEAVY INFESTATIONS, 30 FEET
APART FOR LIGHT. WHEN BOTTOM IS FULL OF BEETLES,
DISPOSE OF TRAP."
are considered too general. Because no upper limit is given, excessive application
of the product may occur. A maximum application rate and frequency of replacing
pheromone must be given.
The Agency has also determined that use sites must be described on the
labeling in order to reflect the plant groups to be protected. Several labels have
no' use site specified, and these labels will .be conditionally eligible. They will
become eligible when revised labels specifying use site are approved by the
Agency.
d. Spray Drift Advisory
This is not applicable to nuranone, because it is in dispensers and not
applied directly to crops.
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 nuranone for the
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.
12
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2. Labeling Requirements for Manufacturing-^Use Products
There are currently no manufacturing use products (MP) registered.
However, in the event that a registrant wishes to register a MP in the future, to be
in compliance with FIFRA, manufacturing use product labeling must 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 a pheromone dispenser for the following use:
as an attractant in a trap."
An MP registrant may, at liis/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 the
support of such use(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding the support of such use(s)."
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 Agency is only requiring a new Confidential Statement of
Formula (EPA Form 8570-4) and amended labeling as additional product specific
data on the currently registered product. No other additional data are required at
this time.
2. Labeling Requirements for End-Use Products
Worker Protection Standard
According to Pesticide Regulation (PR) Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS)", WPS does not apply to
'13
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attractants used in insect traps. Therefore, nuranone is exempt from WPS labeling
requirements.
Maximum Application Rate
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and described in the
Pesticide Reregistration Handbook. As stated in Section IV, the Agency has
determined that labeling must be changed to give a specific maximum application
rate.
Storage and Disposal
In conformity with nuranone's non-food use, labels should read "Do not
contaminate water, food, or feed by storage or disposal."
Other Labeling Requirements
Registrants must specify on labeling the complete directions for use for
each use-pattern: site of application, type of application, timing of application,
equipment used for application, and the rate of application (dosage).
3. 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
nuranone 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.
14
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15
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VI. APPENDICES
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case nuranone covered by this Reregistration Eligibility Decision
Document: It contains generic data requirements that apply to nuranone hi 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 hi the order in
which they appear in 40 CFR Part 158.' the reference numbers accompanying each test refer
to the test protocols set hi 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 hi 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.
20
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is
unique to the citation, and should be used whenever a specific reference is required.
It is not related to the six-digit "Accession Number" which has been used to identify
volumes of submitted studies (see paragraph 4(d)(4) below for further explanation).
In a few cases, entries added to the bibliography late in the review may be preceded
by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific
reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
23
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as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are
contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Adrninistrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed
by an alphabetic suffix which shows the relative position of the study
within the volume.
24
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BIBLIOGRAPHY
MRTO
CITATION
00050873 J.T. Baker Chemical Company (19??) Preparation of Japanese Beetle
Pheromone. (Unpublished study received Aug 14, 1980 under 562- 21-
CDL:243068-A)
00050874 J.T. Baker Chemical Company (1979) Gas Chromatographic Determination of
(R,Z)-5-(l-Decenyl)dihydro-z(3H)-furanone (Synthetic Japanese Beetle
Pheromone). (Unpublished study received Aug 14, 1980 under 562-21;
CDL:243068-B)
00050879 Kane, L.E.; Gallo, M.A.; Weinberg, M.S.; et al. (1979) Evaluation of
38-RD-114: Japanese Beetle Pheromone: Acute Inhalation Toxiciry (Rat):
Snell Project # 3095. (Unpublished study received Aug 14, 1980 under
562-21; prepared by Booz, Allen & Hamilton, Inc., submitted by J.T. Baker
Chemical Co., Phillipsburg, N.J.; CDL:243068-G)
00050880 Gallo, M.A.; Weinberg, M.S.; Gagliardi, JJ. (1979) Evaluation of
8-RD-114: Japanese Beetle Pheromone: Acute Inhalation Toxicity (Rat):
Snell Project # 3095. ([Unpublished study received Aug 14, 1980 under
562-21,; prepared by Booz, Allen & Hamilton, Inc.,submitted by J.T. Baker
Chemical Co., Phillipsburg, N.J.; CDL: 243068-H)
00071692 Doolittle, R.E.; Tumlinson, J.H.; Proveaux, A.T.; et al. (1980) Synthesis of
the sex pheromone of the Japanese beetle. Journal of Chemical Ecology
6(2): 473-484. (Also — In ~ unpublished submission received Apr 8, 1981
under 20954-103; submitted by Zoecon Corp., Palo Alto, Calif.;
CDL:244838-A)
00082161 J.T. Baker Chemical Company (1979) Executive Summary. Summary of
studies 237891-B, 237891-D and 2J37891-G through 237891-J. (Unpublished
.study received Mar 26, 1979 under 562-21; CDL: 237891-A)
00086978 Lui, A. (1980) Japanese Beetle Pheromone: Analytical Analysis: Analytical
Research No. 880-014. (Unpublished study received Nov 4, 1981 under
20954-113; submitted by Zoecon Corp., Palo Alto, Calif.; CDL:246207-C)
41614401 Banfield, M. (1990) Product Chemistry: Product Identity and Composition.
Unpublished study prepared by Consep Membranes, Inc. 118 p.
41614402 Banfield, M. (1990) Product Chemistry: Analysis and Certification of
Ingredients: Lab Project Number: 6/90-JPN/AEP-3. Unpublished study
25
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BIBLIOGRAPHY
MRID
CITATION
prepared by Consep Membranes, Inc. 23 p.
41614403 Banfield, M. ; Murri, B. (1990) Product Chemistry: Physical and Chemical
Characteristics: Lab Project Number: 6/90-JPN/AEP-4. Unpublished study
prepared by Consep Membranes, Inc. 49 p. .
42501001 Anthony, C. (1992) Nuranone/(R,Z)-5-(l-Decenyl) dihydro-2
(3H)-Furanone: Analysis and Certification of Ingredients: Lab Project
Number: 00360-001. Unpublished study prepared by Case Consulting Labs,
Inc. 17 p.
42501002 Anthony, C. (1992) Nuranone/(R, Z)-S-(l-Decenyl) dihydro-2
3H)-Furanone: Physical and Chemical Properties: Lab Project Number:
00360-001. Unpublished study prepared by Case Consulting Labs, Inc. 35 p.
42507101 Conn, R. (1992) Product Identity and Composition of Japonilure (Furanone):
Product Chemistry. Unpublished study prepared by Stewart Pesticide
Registration Associates, Inc. 31 p.
42507102 Conn, R. (1992) Analysis and Certification of Product Ingredients of
Japonilure (Furanone): Product Chemistry: Lab Project Number.
Unpublished study prepared by Stewart Pesticide Registration Associates, Inc.
24 p.
42507103 Conn, R. (1992) The Physical and Chemical Characteristics of Japonilure
(Furanone): Product Chemistry: Lab Project Number. Unpublished study
prepared by Stewart Pesticide Registration Associates, Inc. 7 p.
43069301 Metzger, W. (1993) Nuranone: Product Identity and Certification of Limits.
Unpublished study prepared by United Industries, Inc. 26 p.
26
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The following is a list of available documents related to nurarione. 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 nuranone and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
Nuranone RED Fact Sheet
PR Notice 86-5 (included in this appendix)
3.
4.
5.
PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
27
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