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.

-------
                         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

-------
                        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:

-------
 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.

-------


                   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

-------
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.

-------

-------
REREGISTRATION ELIGIBILITY DECISION

                  Nuranone

                   LISTD

                  CASE 4113
            ENVIRONMENTAL PROTECTION AGENCY
              OFFICE OF PESTICIDE PROGRAMS
        BIOPESTICIDES AND POLLUTION PREVENTION DIVISION

-------
                         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

-------
      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

-------
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

-------
               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

-------
               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

-------
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

-------
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.

-------
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.

-------
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.)

-------
      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.

-------
             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

-------
%'* "* 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):

-------
;• , ' 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

-------
             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.

-------
              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

-------
      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

-------
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

-------
                  "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

-------
       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

-------
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

-------
15

-------
VI. APPENDICES
       16

-------
.  5 'M
                                                                                         al

                                                                                         a
B4J  I

«W
                                                                                                         O        O
                                                                                                         fcj        In
                                                                                                                      Si)
                                                                                                                      m

-------
I
I
    11
                                                                 00   TO
                                              BAJ •

                                              1U
                                               £ S
                                                                                             oo
     8  ,
                                                     1
                                                                 &   8.
 ss

 ss
E

g
g
                                                                             I
                                                                             CO

                                                                             I

-------
                                                                                                              C JJ JJ
                                                                                                              O tt) jj
                                                                                                              -H ^ 0)
                                                                                                              JJ U iH
                                                                                                              -H O  -
                                                                                                              « (0. (D
Microbial cl<

13
ca
rH
3
O
(3
O

jj
CO




3
-H
0).
(D
rH
Dl
5
CO

CO
O

JJ
(0
o
fl
I-t
1



g
-H
CO

ra

£


0)
CO
o
13

§
S
C
S


-a
CD
jj
ret
3
O
iH
C3
U

jj
CO
>i
W,


CD
jj
-H
CO

(H
Dl
.S
CO

fd
o

•H
JJ
S
•H
rH
3

,
JJ T CO

1 =.. .
JJ O ^
aS rH ro
rH Di Q}
i


03 ed o
CO
CD
0 . TH
•JJ i
CO CO O

0 1 -H
•H
§ S "
3s !S
SJJ >
(C -O
-H =
iH « U • jj
a o -H
(0 -H m to
jj -^

*U
^ 3
O «H
-— CJ
SttJ C
co -H"""
•O JJ (8

CO *D
O ^ 0)
•H 
jj • s S
(fl ^— &
U to JJ
•H >t CO >t
rH (0 J3 ffl
0,13 JJ E •
a — HD
< CO 
rH JJ JJ i~t
C CO U CO 3

3  w c si nj
JJ .-H X
c -a to -o
H c) 4J CD jj

f= fj o qi q
§ -H 0 JJ JJ
e jj w w
C CO IH Dl JJ
sS3 £5
                    B3-

                    a rf j= M j=
3 1^
U O
   Di
a «
L4 a:
































































txl
&- ,

05

di
cu
m; u
•H
X U-l
s *d
0)
oi a a) e co
O CO CQ P J-4
£j I VJ -H QJ D
OS 2 O E &1 O
1
to to -
C CO
Jj -H JJ
CO lj rH
.Q oija
(B
- ^ Jj
^ D)
O « -
SJJ JJ
to 0>
CO rH


^ &^
- 2^a
JK -O ffl
O JJ
o -
rH to -
ja o a
JJ C !^
•H 0) JJ
m a co
A CO
-^ x
JJ 0
CO Li JJ
A CD CO
C
oi RI ai"
ra j-> ^
J5 c «
8jj
CO
jj' - -
•H ij 0)
§^-^
•H a
Di O CO
5° .
O fH "«
rH -H O
rH O JZ
O O 0}
. . 14-4
U-l CO jj
o o» «
Dl i4
® -O 3
c -H ja
0 to
JJ. t)
.c j-i  3 CD
g<0 -H -O .Q r-C
U U-l (P fH
&• -O -H -H jJ - 'ty-
gg g-'^gg.S
OtX TO JJjJCJ-H^j
E 2toooei-j
' t

CO
•H




r-t 1
O E3
. i 3
O

S 1
0) CO
CO

•0 C to
CD 0) O


iH CO 4J Q) Dl •-

O O) 3 CO X
C QJ lj


o o o> o) js ^:
2 -H JJ JJ JJ Dl O
JJ OJ CQ (U -i-i ^H
C (0 rH rH ,C CD 	


E-1 D>CIJ OCJ O i-i-H
rtj CO CJ C ID JJ
K' tf) S S .M C
§ U
                                                »  C  CO  Q
                                                I  -H  0  EC
                                                :  s  m  a-

-------
                             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

-------
ATION(S)
 a
 i
I
|
.2
OJ

       VO cs
       5:'*



T> K O
       82
       ©
       oo
       04
       oo
                  u
                  So
                  I5


                       -  S



                \o

                3
                O





                                           \D
                                           O
                                           5




                                o

I
• pa*
S
S
E
     Q
oduct
                       .g
                       i
                           -a
                           J
                           !
                         i
i
                       P3   Cfl
                                         P5
                                       ss'

-------
TATION(S

a
i>
a)
ns
ex
c
•4;

c



a
R
"«
    So
    29
    o co
    m o\
    £2 >S
     o
    O -
                        gg

*§il
       VO
               8
               , vo
                   9
                   4



                                          Q

                                          >

                                          W
             <
             U


                                     ,1.1
                                    • •!••!
                                     JS
            o.
            I-



                        iK
                        & 9 &



                        l
    1
    £
    S
    S

      lltlj
   T*  'T1 T1 T1 T* 'T*
   PQ  PQ PQ CQ BQ P3
   1-1  T-( lH 1—I T-l l-H


                                  0 0 i9
                                       «
                                O

                                o

-------
                        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

-------
       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

-------
                               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

-------
                                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

-------
      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

-------

-------

-------

-------