United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-96-009
June 1996
Reregistration
Eligibility Decision (RED)
Furanone
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W) ____
EPA-738-F-96-009
June 1996
R.E.D. FACTS
Furanone
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1,1984r be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls heeded to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 3138, furanone.
Dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-
furanone (also known as gamma-nonalactone and gamma-undeccalactone,
respectively) are also referred to by the common name furanone. Products
containing furanones are registered for use as insecticides, insect and
mammal repellents, and mosquito larvicides.
Pesticide products containing furanones may be used used as a dog
and cat repellent; fly, cockroach and ant killer; insect repellent, insect
repellent strip, and insect repellent tablecloth; and mosquito larvicide.
Formulations include liquid ready-to-use solutions, emulsifiable
concentrates, granulars and impregnated material.
Furanone is applied by the use of impregnated table cloths,
premoistened applicator puffs, aersol sprayers, non-aerosol hand pump
sprayer, knapsack sprayers, and granules which may be applied by hand.
Use practice limitations include a label statement prohibiting
application directly to treated, finished drinking water reservoirs or drinking
water receptacles. Users also must avoid application to man-made surfaces
sensitive to mineral oils.
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Regulatory Furanone was first registered as a pesticide in the U.S. in 1983 for use
H,StOiy a, a cat repellent. Currently, there are seven furanone products, which are
registered as mixtures with the active ingredient, limonene (Case 3083)
The Agency issued a Reregistered Eligibility Decision (RED) on limonene
m September1994 One of me seven products also contains a third
ingredient, Aliphatic Petroleum Hydrocarbons.
, Human Health Toxicity
Assessment
Acute oral, dermal and inhalation toxicity studies indicate low acute
" H^T* ?• LikeWiS6' 6ye "* demal irritation studies -bo
classified the formulated product in Category IV. The product is not a skin
sensitzer. Data from the open literature on each of the two compounds
considered the furanones to be of low toxicity °rnpounds
WOuM require a 90-day ^nnal toxicity study for
may result in prolonged human dermal exposure through
repeated skin applications. The Agency has decided to waive this
requirement for the furanones based on a combination of the following-
bw exposure to furanones in the product; comparable concentrations of
tools in this product to those already used in cosmetic products (lotions
detergents, perfumes); anaturally occurring compound; and absence of
toxicity m the toxicology studies (notwithstanding limiied data)
Dietary Exposure
fn H C^ren!!yre^SteredP^^
food uses so dietary exposure is not anticipated. Although it is not a
chemical that is Generally Recognized as Safe (GRAS) by the Food and
Drug Administration (FDA), furanone is approved by FDA as a food
additive, and exposures to low concentrations are considered safe
Occupational and Residential Exposure
For the following reasons, the Agency has no concerns regarding
occupational or residential exposure to the furanones: (1) all acute studies
for the furanones indicate that they have low acute toxiciJy (categorylv)
and (2) the furanones are only in pesticide products that also contain
percentage °f furanones i
Human Risk Assessment
A8ency does not "ntidpate occupational or residential risks of
°S t0 thC fUr
. . r "«, iuicuiunea. nowever, as the ruranones
only in pesticide products that also contain limonene, the following
concerns from the limonene RED apply to the furanones.
are
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Environmental
Assessment
Human exposure to furanones/limonene may occur during application
of animal repellent granules or insect spray, or use of impregnated
tablecloths. lexicological concerns for humans from exposure to limonene
include dermal irritation and sensitization. Systemic toxicity is not
anticipated to occur at doses below the threshold for dermal irritation.
Ocular irritation also may occur if products are accidently placed in the eye
and not washed away.
The tablecloth insect repellent product containing limonene was
exempted from tolerance requirements and is not believed to cause
exposure through food. Exposure to limonene would be discontinued by
most users if dermal irritation occurred, and exposure therefore is believed
to be self-limiting. Product labeling required by the limonene RED is
intended to prevent risks of potential skin and eye irritation to users.
Environmental Fate
Environmental fate data are not required to support the low-volume,
outdoor, residential uses of the furanones. However, environmental fate
data generally are required to support aquatic nonfood uses such as the
mosquito larvicide use. A quantitative environmental fate assessment
cannot be made for the furanones at this time because no environmental fate
data have been submitted for review. The furanones are classified as
lactones, and some open literature data are available on physiochemical
; properties of lactones and their possible effect on the environment. The,
reported data indicate lactones may not be stable in alkaline environments.
Ecological Effects
j • .
Acute toxicity data indicate that the formulated product is practically
non-toxic on an acute oral and subacute dietary basis to birds, mammals,
and freshwater fish. The product is slightly toxic to freshwater
invertebrates.
Ecological Effects Risk Assessment
The furanones, when used as mosquito larvicides, are applied directly
to water. The public health larvicidal use of furanones applied at
4.16 Ibs/acre (A) to 6 inches of water results in exceedances of the level of
concern (LOC) for freshwater invertebrates. The LOG for endangered
species is exceeded when the product is applied at 1.64 Ibs/A in water 6
inches deep or less, or when it is applied at 4.10 Ibs/A in water 1 foot deep
or less.
This assessment is based on testing done on a formulated product and
tells little about the actual toxicity of the furanones as' active ingredients.
Chronic invertebrate toxicity data and basic environmental fata data would
improve the Agency's understanding and assessment of the potential risk
posed by the use of the furanones in mosquito larvicides.
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Risk Mitigation
The volume of products containing furanones that are used annually
as mosquito arvicides is low, and the percentage of furanone in me
products is also low. The low volume and low percent of furanone support
Ae conclusion that widespread adverse impacts are not likely to result from
the mojito larvicide use if continued at the amounts currently produced
It should be recognized that the risk posed to aquatic invertebrates is
m°S ^ dI
us
hor» * * ' Pr°dUCtS t0 be harmful to a^uatic invertebrates
because the target species is itself an aquatic invertebrate. The mosquho
larvicide product containing furanones would cause less harm to aquatic
ecosystems than many other products because its risk is limited to aauatic
invertebrates, whereas others pose a risk to fish and birds^well
To lessen the risks to aquatic invertebrates posed by furanones used
as mosquito larvicides EPA is imposing a production limit on fur^one for
use in mosquito larvicides of 150 gallons per year. Should the volume
produced and used and/or the percent of furanone in the product
significantly increase, the Agency would impose the following additional
data requirements to understand and assess potential risks:
161-1, Hydrolysis
161-2, Photodegradation in Water
162-3, Anaerobic Aquatic Metabolism
162-4, Aerobic Aquatic Metabolism
163-1, Leaching/Adsorption-Desorption
164-2, Aquatic Field Dissipation
72-4(b), Life Cycle Invertebrate
f 8fnCyfaIS° is requirinS Product-specific data including product
Fo , ™? 6,tOX1Clty StUdiCS' fevised C^dential Statements of
Formula (CSFs), and revised labeling for registration.
Product Labeling All furanone end-use products must comply with EPA's current
Changes Pesticide product labeling requirements and wim the folbwing Tor a
Required Pnsive Iist of Deling requirements, please see the fufanone RED
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The manufacturing use product (MP) labeling must be revised to
comply will all current EPA regulations, PR Notices and applicable
policies. The MP labeling must bear the following statement under
Direction For Use:
"Only for formulation into an [fill blank with Insecticide, Herbicide
or the applicable term which describes the type of pesticide use(s)]
for the following use(s)[fill blank only with those uses that are being
supported by the MP registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
Regulatory
Conclusion
"Directions for Use" to permit the reformulation of the product for a
specific use or all additional uses, supported by a formulation or user
group:
(a) "This product may be used to formulate products for specific use(s)
hot listed on the MP label if the formulator., user group, of grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
End-use products without the mosquito larvicide use must bear the
following statement:
. "Do not apply directly to water, or to areas where, surface
water is present or to interidal areas below the mean high-water
mark. Do not contaminate water when disposing of equipment
washwater or rinsate."
The use of currently registered products containing furanone in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all furanone
products for all uses are eligible for reregistration.
These products will be reregistered once the required product-specific
data, revised Confidential Statements of Formula, and revised labeling are
received and accepted by EPA. Products that contain active ingredients in
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addition to furanone and limonene will be reregistered when their other
active ingredients also are eligible for reregistration.
Environmental fate and chronic invertebrate toxicity data are not
available and are needed to complete the assessment of risks posed by the
. use of the furanones as mosquito larvicides. However, EPA is not requiring
additional data as long as the production of furanone for this use does not
exceed 150 gallons per year Should the volume produced and used and/or
the percent of active ingredient in the product significantly increase the
Agency may impose additional data requirements in order to develop a
more complete data base regarding these uses of furanone.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for furanone during a 60-day time period as
announced in a Notice of Availability published in the Federal RegisW To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
^™ V?oeld °perations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the REID and this fact sheet can be downloaded
7 4»e?^de5eCiaI ^^ ^ RereSistrati°n Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV or using
WWW (World Wide Web) on WVW.EPA.GOV. '
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
CEPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the furanone RED document also will
be available from the National Technical Information Service (NTIS) 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. '
For more information about EPA's pesticide reregistration program
toe furanone RED, or reregistration of individual products containing '
furanone, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
m recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN) Call toll
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
lime, Monday through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
JUL 2 4 |996
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 Furanone which
includes the active ingredients dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-
furanone. The enclosed Reregistration Eligibility Decision (RED) contains the Agenpy '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 is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the date
of this letter. Complete and timely responses will avoid the Agency taking the enforcement
action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative,
Emily Mitchell at (703) 308-8583. Address any questions on required generic data to the
Planning and Reregistration Division representative, Emily Mitchell at (703) 308-8583.
Sincerely yours
Enclosures
Lois Rossi, Division Director
Special Review
and Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with,the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DC! letter; otherwise, your product
may be suspended.
2- TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
' by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect. '
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a- Application for Reregistration (EPA Form 8570-D. Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b- Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
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, ,d- Two copies of the Confidential Statement of Formula (CSF) for earh h*<^ » A
"' 1- ......... g.
sign EPA
ggSlster Notlce which announces the availability of this RED. ~ •
By U.S. MaH;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
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REREGISTRATION ELIGIBILITY DECISION
Furanone
LIST C
CASE 3138
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
FURANONE REREGISTRATIONELIGIBILITY DECISION TEAM . . .. 1
EXECUTIVE SUMMARY . v
I. INTRODUCTION 1
II. CASE OVERVIEW ....... 2
A. Chemical Overview . 2
B. Use Profile '. -.'..... . .......... '.•'. .....'. 3
C. Estimated Usage of Pesticide *'.' 4
D. Data Requirements .6
E. Regulatory History 6
HI. SCIENCE ASSESSMENT ... . 5
A. Physical Chemistry Assessment 6
B. Human Health Assessment. 9
1. Toxicology Assessment . 9
a. Acute Toxicity '...... 9
b. Subchronic Toxicity . 11
c. Chronic toxicity 12
d. Carcinogenicity 12
v e. Other Toxic Endpoints 12
f. Reference Dose 13
2. Exposure Assessment 13
s a. Occupational and Residential ..... ... . . . 13
3. Risk Assessment i 14
a. Occupational and Residential f 14
C. Environmental Assessment . . . .14
1. Ecological Toxicity Data 14
a. Toxicity to Terrestrial Animals 15
b. Toxicity to Aquatic Animals . : . 17
2. Environmental Fate Assessment 19
3. Exposure and Risk Characterization 20
a. Ecological Exposure and Risk Characterization .20
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 26
A. Determination of Eligibility ..............; . 26
B. Determination of Eligibility Decision ' ] ' 26
1. Eligibility Decision 26
2. Eligible and Ineligible Uses 27
C. Regulatory Position ^'. ........ 27
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2.
Endangered Species Statement . .............. 28
V.
ACTIONS REQUIRED OF REGISTRANTS ! 28
A. Manufacturing-Use Products 28
1. Additional Generic Data Requirements 28
2. Labeling Requirements for Manufacturing-Use Products 29
End-Use Products 3Q
1. Additional Product-Specific Data Requirements .... . . 30
2. Labeling Requirements for End-Use Products 30
Existing Stocks ,1
B.
C.
VI.
33
APPENDICES .......................
f^^SSIX A* TaWe °f Use Patterns Subject to Reregistration . . 34
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision .......... 40
Citations Considered to be Part of the Data Base Supporting the
AQ
''''''''''''''''
APPENDIX C.
Reregistration of Furanone
APPENDIX D. Generic Data Call-in
Attachment 1. Chemical Status Sheets 74
Attachment 2. Generic DCI Response Forms Inserts (TForm A) plus
Instructions 7-
Attachinent 3. Requirements Status and Registrants'Response Forms
Inserts (Form B) plus Instructions 73
APPEl^T1* t A ^ rf ***«*« ^nt this DCI ansert) . . . . . \ 83
APPENDIX E. Product Specific Data Call-In 85
Attachment 1. Chemical Status Sheet 99
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions IOQ
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 102
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 109
Attachment 5. List of Registrants) sent this DCI (Insert) 111
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 112
APPENDIX F. List of Available Related Documents ..'.'.'.'.'.'.'.'. . n8
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FURANQNE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Alan Halvorson
William Gross
Thomas C. Harris
Environmental Fate and Effects Division
Mary Powell
Nick Mastrota
James Hetrick
Health Effects Division .
John Redden
LinneaHansen
Winston Dang
Registration Division
Mark Perry
Sami Malak
Beth Edwards
Special Review and Reregistration Division
Emily Mitchell
Barbara Briscoe
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Gfoundwater Branch
Risk Characterization and Analysis Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Planning and Reregistration Branch
Planning and Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Office of Compliance Monitoring:
Phyllis Flaherty
Pesticides Enforcement Policy Branch:
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11
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ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FDA
HERA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LC™
LD,
LD10
LEL
LOG
LOD
LOEL
MATC
MCLG
Mg/g
mg/L
MOE
MP
MPI
MRID
N/A '
NOEC
NPDES
GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent
, Active Ingredient - - - . .
Anticipated Residue Contribution
Chemical Abstracts Service
Cation •
Central Nervous System • ,
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, nori carcinogenic health effects are not anticipated to
occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act , ,
Functional Observation Battery .
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose, Tested
Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.. -
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level
Level of Concern
Limit of Detection .
Lowest Observed Effect Level .
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No effect concentration
National Pollutant Discharge Elimination System
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL
NOAEL
OP
OPP
PADI
PAG
PAM
PHED
PHI
1 ppb
PPE
ppm
PRN
Q*.
RBC
RED
REI
RfD
RS
SLN
TC
TD
TEP
TGAI
TLC
TMRC
torr
FAO/WHO
WP
WPS
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate ,
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
ial °f a C°mpOUnd' Quantified ^ *e EPA's Cancer Risk Model
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Special Local Need (Registrations Under Section 24 (c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect
loxic Dose. The dose at which a substance produces a toxic effect
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
£j? °H A"*8"? Me?d t0 SUPP°rt a C°lumn of mercury 1 mm fogh «nder standard conditions
Food and Agnculture OrganizationAVorld Health Organization conoiuons.
Wettable Powder
Worker Protection Standard
IV
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision Document (RED) addresses the reregistration
.eligibility of two active ingredients: dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-
2(3H)-furanone (also known as gamma-nonalactone and gamma-undecalactone, respectively).
Both of these active ingredients are also referred to by the common name furanone. Products
containing furanones are registered for use as insecticides, repellents, mammal repellents and
mosquito larvicides.
The Agency first registered a product containing furanone in 1983 for use as a cat
repellent. Later, the Agency registered six additional products as insect toxicants, including use
as a mosquito larvicide, or repellents. At present, there are seven furanone products, which are
all registered as mixtures with the active ingredient, limonene (Case 3083). The Agency issued
a Reregistered Eligibility Decision (RED) on limonene in September 1994. One of the seven
products also contains a third active ingredient, Aliphatic Petroleum Hydrocarbons.
The Agency has determined that all uses of furanone products, labeled and used as
specified in the RED, will not pose unreasonable risks to humans or the environment and,
therefore, are eligible for reregistratipn.
Acute toxicity tests to assess both human toxicity and toxicity to non-target organisms
were conducted on a formulated product containing : .024% dihydro-5-pentyl-2(3H)-furanone,
.049% dihydro-5-heptyl-2(3H)-furanone, and 4.015% limonene. No toxicity data are available
on the technical. .
Acute oral, dermal, and inhalation toxicity studies indicate low acute toxicity (Category
IV). Likewise, eye and dermal irritation studies also classified the formulated product in
Category IV. The product also is not a skin sensitizes Data from the open literature on each of
the two compounds considered, the furanones, indicate low toxicity.
Acute toxicity data indicate that the formulated product is practically non-toxic to birds
(oral, subacute dietary), .mammals, and freshwater fish. The product is slightly toxic to
freshwater invertebrates.
The furanones, when used jn mosquito larvicides, are applied directly to water (residential
and large scale public health use.) The public health larvicidal use of furanones applied at 4.10
Ibs/A to 6 inches of water results in exceedances of the level of concern for freshwater
invertebrates. The LOG for endangered species is exceeded when the product is applied at 1.64
Ibs/A in water 6 inches deep or less, or when it is applied at 4.10 Ibs/A in water 1 foot deep or
less. This assessment is based on testing done on a formulated product and tells little about the
actual toxicity of the furanones as active ingredients. Chronic invertebrate toxicity data (life cycle
test with a freshwater invertebrate) and basic environmental fate data
-------
would improve the Agency's understanding and assessment of the potential risk posed by the use
of the furanones m mosquito larvicides. .
i< low v°lume^Products containing furanones that are used as mosquito larvicides
£ ™ f ? P61061*3*6 of taone in the products is also low. The low volume used and low
percent of furanone support the conclusion that widespread adverse impacts are not likely to
aX~r&^^
production Hmit on furanone L use in mosqui^Scide 5 'l£££ ™ y
volume product and used and/or the percent of furanone in the pfoduct s£ficanth toae
the. Agency may impose additional data requirements to understand and assfss potentials
It should be recognized that the risk posed to aquatic invertebrates is common to most
^ ****" USe' ft 1S the natUfe °f mos^to larvicide« to be harmfu?to aquatic
because the target species is itself an aquatic invertebrate The mosquito
^^ ld CaUSC I6SS ha™ to *^c ecosysTels Z m
3qUatiC invertebra^' **ereas others pose a risksh
Before reregistering the products containing furanone, the Agency is requiring that oroduct
specific data, revised Confidential Statements of Formula (CSF) and 1 revised ?abeHn?lx ^subrnkted
within eight months of the issuance of this document. These data incluS ^producfche^ for
each lustration and acute toxicity testing. After reviewing these d fa^y ^ M ^SlTa^d
finding them actable in accordance with Section 3(c)(5) of FIFRA, the Agen^ wHl rerelTer
a product Those products which contain other active ingredients^ I™ £ TelSf for
*" Other "^ in "etermilt £ ^ ! for
VI
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process.The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of furanone. The document consists of six sections. Section I is the
introduction. Section II describes furanone, its uses, data requirements and regulatory history
Section IE discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for furanone . Section V discusses
the reregistration requirements for furanone . 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
Decision^ ^U°Wing active ingredient(s) are covered by this Reregistration Eligibility
+ Common Name: Furanone
+ Chemical Name: Dihydro-5-pentyl-2(3H)-furanone
+ Alternate Name: gamma-nonalactone
+ CAS Registry Number: 104-61-0
* OPP Chemical Code: 122301
* Empirical Formula: CgHj^
* Trade and Other Names: Doo-Not
* Basic Manufacturer: Rod Products Company
Common Name:
Chemical Name:
Alternate Name:
Furanone
Dihydro-5-heptyl-2(3H)-furanone
gamma-undecalactone
CAS Registry Number: 104-67-6
OPP Chemical Code: 122302
Empirical Formula: CnH20O2
Trade and Other Names: Doo-Not
Basic Manufacturer: Rod Products Company
-------
B. Use Profile
The following is information on the currently registered uses for furanone. A
detailed table of eligible uses as well as the methods, application rates, and use restrictions
is included in Appendix A.
For: dihydro-5-pentyl-2(3H) furanone
For: dihydro-5-heptyl-2(3H) furanone
Type of Pesticide: Insecticide/repellent, mammal repellent, mosquito larvicide
Currently registered products, containing these chemicals, have the following uses:
1) dog and cat repellent;
2) fly, cockroach and ant killer;
3) insect repellent;
4) insect repellent strip;
5) insect repellent tablecloth; and
6) mosquito larvicide (contains mineral oil).
Use Sites: Terrestrial. Non-Food & Outdoor Residential
\ ' ~ '• ' ' •
Target Pests: cats, dogs, house flies, cockroaches, ants, biting flies, mosquito
adults and larvae
Formulation Types Registered: Granular
. Liquid Ready-to-use
Impregnated Material
Emulsifiable Concentrate
. Pressurized Liquid
Percentage of the three AIs in all formulations
Active Ingredient Weight Percentage in formulations
d-Limonene 4.015%
gamma-Undecalactone 0.049%
gamma-Nonalactone 0.024%
There are no formulations that contain the furanones alone.
-------
Method and Rates of Application:
Equipment -
Method and Rate -
Use Practice Limitations:
Hand, pre-moistened applicator puffs, aerosol
sprayers, non-aerosol hand pumped sprayers,
hydraulic ground sprayers, aircraft, compressed air
sprayers and knapsack.
Furanone may be applied by the use of impregnated
table cloths, premoistened applicator puffs, aersol
sprayers, non-aerosol hand pumped sprayer,
knapsack sprayers, and the granules may be applied
by hand by .sprinkling from the bag.
Some product labels do not provide adequate
information to calculate rates; however, for those
that can be calculated they are as follows:
granules are applied at rates of 0.002 Ib ai/1000
square feet, and for the emulsifiable concentrate for
mosquito larvae control, the rates range from 0 0393
to 0.0984 Ibai/acre.
Product labels do not give specific timing of
application of this product. The language reads-
. "when needed."
Do not apply directly to treated, finished drinking
water reservoirs or drinking water receptacles.
Avoid application to man-made surfaces sensitive to
mineral oils.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
furanone. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop' basi7
reflect annual fluctuations m use patterns as well as the variability in using data from
various information sources.
-------
."..-.. The table below summarizes the pesticides use by site.
Estimated Typical Annual Usage of Furanone (Dihydro-5-pentyl-2(3HMuranone and 5-HeDtvIdihvdrn-2ttHVf,,rannn.>l
Drainage systems
Eating establ incl servg areas
Flooded areas, intermittent
Food marktg/storg/distr facils
Food proc/hndl/stor pits/areas
Garbage dumps/manure
Households, indoor/outdoor
Human body/hair/clothg/footwr
Lakes/ponds/impounded water
Omarri herbaceous plants/lawns
Omam ponds/fountains/aquaria
Paved areas
Recreation areas
Refuse/solid waste containers
Swamps/marshes/bogs/stdg water
Wide area/gen indr/outdr trtmt
TOTAL
Site
Available
(000)
na
na
na
na
na
na
90.000H
250.000P
na
30.000A
na
na
na
na
na
na
na
Site Treated
(000)
na
na •
OOH
<2SOP
na
<30A
na
na
(%)
<1
<1
<1
<1
<1
<1
<1
<1
<1
<1
<1
<1
<1
<1
-------
probably considerably less than one percent of available recreation areas, however measured are
treated with furanone.
D. Data Requirements
Data requested in the Phase IV Data Call-in Notice(s) for furanone (dihydro-5-
pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-furanone) include studies on product
chemistry and environmental fate. These data were required to support the uses listed
in the Phase IV Data Call-in Notice(s), dated July 27,1992. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed to support
reregistration. v*
E. Regulatory History
The Agency first registered a product containing furanone in 1983 for use as a
dog and cat repellent. Later, the Agency registered six additional products as insect
toxicants, including use as a mosquito larvicide, or repellents. At present, there are seven
furanone products, which are all registered as mixtures with the active ingredient
hmonene (Case 3083). The Agency issued a Reregistration Eligibility Decision (RED)
on hmonene in September 1994. One of the seven products also contains a third active
ingredient, Aliphatic Petroleum Hydrocarbons.
The compounds dihydro-5-heptyl-2(3H)-furanone (also known as gamma-
undecalactone) and dihydro-5-pentyl-2(3H)-furanone (also known as gamma-
nonalactone) are compounds that appear on the 'GRAS' ("generally recognized as safe")
list of the Expert Panel of the Flavoring Extract Manufacturers' Association of the United
States (FEMA). These same compounds are not on the FDA 'GRAS' list but are
approved as food additives by the FDA. '
IH. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The following physical/chemical property information was extracted from MRID
No. 240229307 (Product Chemistry) and is supplied as background material, and from
two monographs in Food and Cosmetics Toxicology (FD Cosmet Toxicol Vol 12 889
and 921 1975). '
The data for the active ingredients were extracted from the Food Chemicals Codex
f ** ^ °n pages 456> 457> 844> 845>553 ™d 554. The first active, dihydro-5-heptyl-
2(3H)-furanone, is referred to as Undecanoic acid, 4-hydroxy, gamma-lactone by the
registrant. The active ingredient product name is gamma-Undecalactone. The second
active dihydro-5-pentyl-2(3H)-furanone (on submitted material this active ingredient is
-------
referred to as: 2(3H)-furanone dihydro-5-pentyl; MW=156.25) is synonymous to gamma-
Nonalactone (active ingredient product name).
dihydro-5-heptyl-2(3H)-furanone Properties
o
o
o
o
o
o
o
o
o
o
o
o
M.W. - 184.31
Color - colorless to yellow
Odor - strong fruity odor suggestive of peach
Melting point - liquid, not applicable
Sqlubility - 60% alcohol in water - 20% soluble
70% alcohol in water - 33% soluble
Insoluble in water
Stability - stable under all normal conditions
Octanol/water partition coefficient - not available
Physical state - liquid
Density - 0.942 - 0.945
Vapor Pressure - not available
pH - not available
Structural Formula: CH3(CH2)6 CH CH2CH2
O-
•c=o
Extracted from Food and Cosmetics Toxicology Volume 13, 921,1975.
-------
dihydro-5-pentyl-2(3H) furanone Properties
o
o
o
o
o
M.W. - 156.25
Color - colorless to yellow
Odor - strong odor suggestive of coconut
Melting point - liquid, not applicable
Solubility - 50% alcohol in water - 20% soluble
60% alcohol in water - 33% soluble
Insoluble in water
Stability - stable under all normal conditions
Octanol/water partition coefficient - not available
Physical state - liquid
Density - 0.958 - 0.966
Boiling point - 243 °C
Vapor Pressure - not available
pH - not available
Structural Formula: CH3(CH2)4 CH CH2CH2
Extracted from Food and Cosmetics Toxicology Volume 13, 889,1975.
o
o
o
o
o
o
o
o
-------
B.
Hunian Health Assessment
1. Toxicology Assessment
The lexicological data base on furanones is adequate to support
reregistration eligibility for dihydro-5-pentyl-2(3H)-furanbne (PC CODE: 122301
synonymous to gamma-Nonalactone) and dihydro-5-heptyl-2(3H)-furanone (PC
CODE: 122302 synonymous to gamma-Undecalactone).
a. Acute Toxicity
ACUTE TOXICITY DATA FOR FURANONES
'tfeS? ' " ""
Oral LDSO-rat, Monogram Animal Repellent #100(Limonene) '
Dermal LD50— rabbit, Monogram Animal Repellent
#100(Limonene)J
Inhalation LC50— rat, Monogram Animal Repellent
tflOOCLimonene)1
Eye irritation-rabbit, Monogram Animal Repellent
fllOOCLimonene)1
Dermal irritation—rabbit, Monogram Animal Repellent
#100(Limonene)'
Dermal sensitization— Guinea pig, Monogram Animal Repellent
#100(Limonene)1
&ESTILTS
LD50 > 5 gm/kg
LD50 of dry formulation
> 5 gm/kg
LC50 > 5 mg/1, using
particle size of 297
microns or less.
PIS - Washed = 0.0. PIS -
Unwashed = 0.0
PIS = 0.0
Primary Irritation Score
No sensitization using -
draize technique
"CATEGORY
IV
IV
IV
IV
IV
—
containing furanones also contain limonene.
It should be noted that only acute studies On formulations were
conducted to support the reregistration of gamma-Undecalactone and
gamma-Nonalactone. There are no toxicity data available on the technical.
Toxicity data on the two compounds which comprise the furanones are
available from the open literature and are discussed below:
The following was extracted from two monographs that appeared
in Food and Cosmetics Toxicology (FD. Cosmet. Toxicol. Vol. 12, pp 889
and 921, 1975).
-------
gamma Nonalactone:
"The acute oral LD50 in rats and guinea pigs was reported as 9 78
and 3.44 g/kg, respectively (Jenner, Hagan, Taylor, Cook &
Fitzhugh, 1964). The acute oral LD50 in rats was reported as 6 6
g/kg (5.8-7.4 g/kg) (Moreno, 1972a). The acute dermal LD50 in
rabbits exceeded 5 g/kg (Moreno, 1972b)."
Based on this information the toxicity category established in both
rat studies, for nonalactone, would be IV for acute oral toxicity The
toxicity category based on the guinea pig acute oral LD50 study would be
III for nonalactone.
"Nonalactone applied full strength to intact or abraded rabbit skin
for 24 hr under occlusion was slightly irritating (Moreno, 1973b)
Tested at 10% in petrolatum. It produced no irritation after a 48 hr
closed-patch test on human subjects (Kligman 1972) A
maximization test (Kligman, 1966: Kligman & Epstein, 1975) was
carried out on 25 volunteers. The material was tested at a
concentration of 10% in petrolatum and produced no sensitization
reactions (Kligman, 1972)."
gamma Undecalactone:
"The acute oral LD50 in rats was reported as 18.5 g/kg (Jenner
Hagan, Taylor, Cook & Fitzhugh. 1964). Fatty infiltration of liver
parenchymal cells occurred in rats fed 13-115 mg gamma-
undecalactone for 5-9 days (Shillinger, 1950)."
"Gamma-Undecalactone tested at 2% in petrolatum produced no
irritation after a 48-hr closed-patch test on human subjects
(Kligman, 1971). A maximization test (Kligman, 1966; Kligman
& Epstein, 1975) was carried out on 25 volunteers. The material
was tested at a concentration of 2% in petrolatum and produced no
sensitization reactions (Kligman, 1971)."
The acute oral LDSO in rats for undecalactone would be classified
as toxicity category IV. The studies on undecalactone are classified as
Supplementary as they are from the open literature.
However, they offer valuable information for the evaluation of the
toxicity of the furanones because these data indicate that the two
compounds that make up the furaaones are of low acute toxicity
10
-------
b. Subchronic Toxicity
In an open literature study (Fd Cosmet. Toxicol. Vol. 3, pp. 563-
569. Pergamon Press 1965) gamma-Undecalactone and gamma-
Nonalactone were two of 23 flavoring compounds that were examined in
subchronic feeding studies.
Fifteen female FDRL and fifteen male FDRL rats were fed the
following for 90 days: females were fed 14.6 mg/kg body weight/day
gamma-undecalactone and 62.8 mg/kg body weight/day gamma-
nonalactone; males were fed. 16.5 and 72.5 mg/kg body weight/day
gamma-undecalactone and gamma-nonalactone, respectively.
Body weight, food consumption, haematological and blood
chemical determinations were made on 8 rats of each sex after 6 weeks of
dosing, and in all rats at 12 weeks. The study was terminated after 90 days
and tiie rats were necropsied. Liver and kidney weights were recorded for
all rats. The following organs from half me animals in each group were
taken for histological examinations: liver, kidneys, stomach, small and
large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle,
brain, spinal cord, bladder, adrenals/thyroid, pituitary, gonads, salivary
glands, and lymph nodes. '
The study authors conclusions are presented below and the Agency
agrees with their assessment:
"No significant gross pathological change was observed at
autopsy in any rats...Several of the animals in the groups
receiving the lactones (L,M,N)..:.show various degrees of
.. ~ . mild thyroid hyperplasia but this observation was also noted
in the .corresponding control groups and is not uncommon
finding in these laboratories."
"90-Day feeding studies in groups of rats receiving dietary
doses of any of 23 different flavouring matters at levels
corresponding to at least 100 times the maximum estimated
human dietary levels, revealed no evidence of adverse toxic
effects."
Since this is an open literature study it must be core graded
Supplementary. However, it supplies useful information in evaluating
the potential hazard of the furanones in that compounds making up the
11
-------
furanones did not demonstrate a hazard following subchronic oral
administration.
c. Chronic toxicity •
The following was extracted from two monographs that appeared
in Food and Cosmetics Toxicology (FD. Cosmet. Toxicol Vol 12 DD 889
and 921, 1975). ' .'.
Nonalactone:
"...In another study 0.1-0.5% fed to groups of 20 male and
female rats in the diet for 2 yr produced no effects (Bar &
Griepentrog. 1967)."
Undecalactone:
"...Groups of 20 male and 20 female rats were fed diets
containing 0.1 or 0.5% gamma-undecalacone for 2 yr
without any specific adverse effects (Bar & Griepentroe
1967)." 5'
These studies are classified as Supplementary as they appear in
the open literature. However, they offer valuable information for the
determination of the toxicity of the furanones in that the compounds
making up the furanones did not demonstrate a hazard following chronic
oral exposure.
d. Carcinogenicity
No effects were observed in a 2 year rat study where rats were
administered 0.10% to 0.5% furanones in their diet (Bar F U
Griepentrog. F. (1967)).
e.
Other Toxic Endpoints
The Agency has determined that a 90-day dermal toxicity (safety)
study would be required for a product that may result in prolonged human
dermal exposure through repeated skin applications. The Agency has
decided to waive the requirement for the 90-day dermal toxicity for the
furanones based on the following : a combination of low exposure to
furanones in the product; comparable concentrations of tanols in this
product to those already used in cosmetic products (lotions, detergents
12
-------
perfumes); naturally occurring compound and absence of toxicity in the
toxicology studies (notwithstanding limited data). Also, although not a
FDA GRAS chemical, furanone is approved by FDA as a food additive
and exposures to low concentrations are considered safe.
f. Reference Dose
There are no registered food uses for the furanones. The Agency's
Peer Review Committee has not considered the furanones. The Joint
FAO/WHO Expert Committee on Food Additives established an
unconditional ADI of 0-1.25 mg/kg for undecalactone and nonalactone.
2. Exposure Assessment
a. Occupational and Residential
For the following reasons the Agency has no concerns for
occupational or residential exposure to the furanones: 1) the acute battery
for the furanones indicate toxicity category IV; and 2) the furanones are
only in formulations containing limonene and the percentage in
formulations is less than 1%.
However, there is a concern that repeated high dose dermal
exposure to limonene may cause dermal sensitization based on a two week
preliminary study for a rat 90 day dermal toxicity study. The data
demonstrated that dermally applied technical limonene at 500, 1000, or
1500 mg/kg/day produced excessive dermal irritation after 1-3 days of
dermal application. No overt treatment related systemic toxicity or clinical
signs were observed.
Since these effects occur after repeated high dose administration
of limonene, for purposes of reregistration, the following from the
Limonene RED, applies to the tanol derivatives:
"The primary toxicological concerns for humans are dermal
irritation and/or sensitization from dermal exposure at high
concentrations. Systemic toxicity is not expected to occur
from pesticide uses since dermal irritation, which occurs at
high doses, results in self-discontinuation of product use."
13
-------
Thus, since the most noted dermal effect would be self limiting
dermal irritation resulting from the limonene and not the furanones the
Agency does not anticipate occupational or residential risks of concern
from exposure to the furanones.
3. Risk Assessment
a. Occupational and Residential
For the reasons discussed above, the Agency does not anticipate
occupational or residential risks of concern from exposure to the
furanones. However, as the furanones are only in formulations containing
hmonene, the following from the limonene RED applies to the furanones:
"Human exposure may occur during application of animal
repellent granules or insect spray, or use of impregnated
tablecloths. The tablecloth product containing limonene to
repel insects was exempted from tolerances. Toxicological
concerns for humans from exposure to limonene are dermal
irritation and sensitization. Systemic toxicity is not
anticipated to occur at doses below the threshold for dermal
irritation. Exposure to limonene would be discontinued if
dermal irritation occurred and therefore self-limiting.
Ocular irritation may also occur if products are accidently
placed in the eye and not washed away."
"Additional precautionary statements on label are required
to reduce adverse effects."
C. Environmental Assessment
1. Ecological Toxicity Data
The term "furanones" will be used to refer to the two related chemicals
covered by this RED: dihydro-5-pen1yl-2(3H)-furanone and 5-heptyldihydro-
2(3H)-furanone. All of the formulated products containing these furanones also
contain a third active ingredient, limonene. All of the toxicity data for furanones
are tor one formulated product, Doo-Not Dog & Cat Repellent (Reg No 45987-
1), containing the three active ingredients in the following concentrations'
14
-------
PC Code "
122301
122302
079701
...£ - Nam^ % '"
Dihydro-5-pentyl-2(3H)-furanone
5-heptyldihydro-2(3H)-furanone
Limonene
' %Ll
0.024%
0.049%
4.015%
The other registered formulations containing furanones contain the same
set of active ingredients as Doo-Not in identical concentrations, although
Rodspray Mosquito Larvicide (Reg. No. 45987-6) also contains 22.94% white
mineral oil as a fourth active ingredient.
There are adequate data to assess Hie hazard of the formulated product
Doo-Not, as well as otiier products that contain furanones in identical
concentrations as Doo-Not and have low-volume minor uses. Only the six basic
studies are required for these use patterns because they are expected to result in
low exposure to the environment. The mosquito larvicide use is exceptional in
that it may result in relatively large exposures to aquatic habitats. An additional
chronic aquatic invertebrate study on the technical grade of the active ingredient
is needed to clarify the Agency's understanding and assessment of the potential
nsk posed by the use of furanone as a mosquito larvicide.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
To establish the toxicity of furanones to birds, the following
tests are required using the technical grade material: one avian
single-dose oral (LD^ study on one species (preferably mallard or
bobwhite quail); two subacute dietary studies (LC50) on one species
bf waterfowl (preferably the mallard duck) and one species of
upland game bird preferably bobwhite quail). Data that have been
submitted for these three tests have been with a formulated product,
not the technical grade material. The following tables show the
results of these tests.
15
-------
.• -*»$
Species
Northern
Bobwhitc
^%k-J ,' -"X;>
V.A.I.-
4.0 15% 079701
0.024% 122301
0.049% 122302
)•,, '^ v "A»*t«AHrti»<^r«(j;j1o^jciry^»dssg$ '''' j.
LDj, mg/kg
>2000
MRIDNo.
Author/Year
109340
Bottoms, J. (1982)
Toxicity Category
The formulated product is
practically nontoxic
Active mgreaients are listed by their Shaughnessey numbers. ' '
Fulfills Guideline
Requirement
Yes, for the formulated
product Doo-Not Dog
Repellent
^ v tJJ^T^J
Species
Northern
Bobwhitc
Mallard
^S?%
%A.I,
4.0 15% 079701
0.024% 122301
0.049% 122302
4.0 15% 079701
0.024% 122301
0.049% 122302
\ %>S, '"" "••"
itCff ppm
>5000
>5000
;«% '" ' ' "'" "";;iN'JNM|....iu mi, M..i....ni,,,,,,,M.u.,m, I.M.I,,., M,,,,,,,,,,..|
MRIDNo.
Author/Year
109342
Bottoms, J. (1982)
109341
Bottoms,!. (1982)
Toxicity Category
The formulated product is
practically nontoxic
The formulated product is
practically nontoxic
Active ingreaicms are listed by their Shaughnessey numbers. ' l
Fulfills Guideline
Requirement
Yes, for the
formulated product
Doo-Not Dog
Repellent
Yes, for the
formulated product
Doo-Not Dog
Repellent
These results indicate that the formulated product Doo-Not
Dog Repellent is practically nontoxic to avian species on an acute
oral and subacute dietary basis (MRID 109340-109341). However,
since this product contains only a .small percent of active
ingredient, it cannot be inferred from these results that furanones
are practically nontoxic. If the furanones caused all of the toxicity
of the formulated product, an estimated acute oral LD50 of the
furanones for avian species would be >1.46 mg ai/kg and an
estimated subacute dietary LC50 would be >3.65 ppm ai. These
results tell little about the actual toxicity of the furanones as active
ingredients. Furanones may fall into any of five toxicity
classifications.
(2) Mammals
Wild mammal testing is required on a case-by-case basis
depending on the results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent environmental
fate characteristics.
16
-------
The oral rat LD50 for Dpo-Not Dog & Cat Repellent (Reg.
No. 45987-1) is. >5 g/kg (Accession No. 245190). This result
indicates tiiat Ihis formulated product is practically nontoxic, but it
tells little about the toxitity of furanones as active ingredients. If
all of the toxicity of the formulated product was caused by the
furanones, an estimated acute oral LD50 of the furanones for avian
species would be >3.65 mg ai/kg. Furanones thus may fall into any
of five toxicity classifications.
Toxicity to Aquatic Animals
(1) Freshwater Fish
. ' ' ' p '
To establish the toxicity of'a pesticide to freshwater fish, the
minimum data required on the technical grade of Ihe active
ingredient are two freshwater fish toxicity studies.' One study
should use a coldwater species (preferably the rainbow trout), and
the other should use a warmwater species (preferably the bluegill
sunfish). Data that have been submitted for these two tests have
been with a formulated product, not the technical grade material.
The following table shows the results of these tests.
>-, ,,,. . -v
Species
Rainbow trout
- Fathead minnow
HA*
4.0 15% 079701
0.024% 122301
0.049% 122302
4.0 15% 079701
0.024% 122301
0.049% 122302
'" \ '" "
LCj, ppm a.i.
569*
1490*
^',L*\0.42 ppm a.i. for the rainbow trout and >1.1 ppm a.i. for the
fathead minnow. These results tell little about the toxicity of the
furanones as active ingredients. Furanones could fall into any
17
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toxicity classification except very highly toxic. (MRID No.
109343) *
Because the tests were conducted with formulated product
raflier than technical grade active ingredients, they do not fulfill the
guideline requirements for furanones. However, these data are
considered adequate for assessing the risk of the use of the Doo-
Not product. They may also be adequate for other low-use
products that contain furanones in identical concentrations.
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of a
pesticide to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
Data that have been submitted for a test with Daphnia magna have
been with a formulated product, not the technical grade material.
The table below gives the results of these tests.
*- .^r?;
Species
Daphnia magna
"• s *• O>- >f-
%AX-
4.0 15% 079701
0.024% 122301
0.049% 122302
^^^^^m^^: * *' """V ; ' -- ""' ''
EC,.
(ppm)
If
MRID NO.
Author/Year
109345
Bottoms, J. (1982)
Toricity
Category
The formulated
product is
slightly toxic
Fulfills Guideline
Requirement
Supplemental, for
formulated product Doo-
. Not Dog Repellent
Result is based on the moving average method.
There is sufficient information to .characterize the
formulated product containing furanones as slightly toxic to aquatic
invertebrates (MRID 109345). However, since this product
contains only a small percent of active ingredient, it cannot be
inferred from these results that furanones are slightly toxic to
freshwater invertebrates. Assuming that all of the toxicity of the
formulated product was; caused by the furanones, the estimated
acute LCso of the furanones is >0.012 ppm a.i. for Daphnia magna.
These results probably overestimate the toxicity of furanone
because much of the toxicity of the formulated product could be the
result of the other active ingredient, limonene, or of inert
ingredients. These results tell little about the actual toxicity of the
furanones as active ingredients. Furanones may fall into any of
five toxicity classifications (MRID 109345).
18
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Because the tests were conducted with formulated product
rather than technical grade active ingredients, they do not fulfill the
.guideline requirements for furanones. However, these data are
considered adequate for assessing the risk of the use of the Doo-
Not product. They may also be adequate for other low-use
products that contain furanones in identical concentrations.
A life-cycle test with a freshwater invertebrate (guideline
72-4b) is needed for the mosquito larvicide use of furanones
because it involves direct application to water and because some of
the acute risk quotients for freshwater invertebrates are greater than
0.01. This guideline requirement is not fulfilled.
2. Environmental Fate Assessment
Environmental fate data are not required to support low-volume outdoor
residential uses for the furanones. Environmental fate data generally are required
to support aquatic nonfood uses. To complete an ecological risk assessment for
fte mosquito larvicide use, the Agency needs the following data to assess the
dissipation of the furanones in the environment:
, 161-1, Hydrolysis
161-2, Photodegradation in Water
162-3, Anaerobic Aquatic Metabolism
162-4, Aerobic Aquatic Metabolism
163-1, Leaching/Adsorption-Desorption
164-2, Aquatic Field Dissipation
A quantitative environmental fate assessment for the furanones cannot be
made at this time because no environmental fate data have been submitted for
rev,ew. However, the furanones are classified as lactones, and some open
literature data are available on physiochemical properties of lactones and their
possible effect on the environment.
, u u LJactones «* ^dic esters *at can be synthesized by acidification of
alpha-hydroxy acids. Detoxification mechanisms of lactones can be accomplished
through base-catalyzed hydrolysis or microbial-mediated degradation of reactive
groups. De-esterification may be catalyzed by metal ions, enzymes, and
nucleophihc attack. The reported data indicate lactones may not be stable in
alkaline environments.
19
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3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level o f
Concern (LOC): The Levels of Concern are criteria used to indicate
potential risk to nontarget organisms. The criteria indicate that a chemical,
when used as directed, has the potential to cause undesirable effects ori
nontarget organisms. There are two general categories of LOC (acute and
chronic) for, each of the four nontarget faunal groups and one category
(acute) for each of two nontarget floral groups. In order to determine if an
LOC has been exceeded, a risk quotient must be derived and compared to
the LOCs. A risk quotient is calculated by dividing an appropriate
exposure estimate, e.g. the estimated environmental concentration (EEC),
by an appropriate toxicity test effect level, e.g. the LC50. The acute effect
levels typically are:
- EC^ (terrestrial plants),
- EC50 (aquatic plants and invertebrates),
- LCSO (fish and birds), and
- LD50 (birds and mammals)
The chronic test results are the:
-NOEL (or NOEC) for avian and mammal reproduction studies, and either
the NOEL for chronic aquatic studies, or the Maximum Allowable
Toxicant Concentration (MATC), which is the geometric mean of the
NOEL and the LOEL (or LOEC) for chronic aquatic studies.
When the risk quotient exceeds the LOC for a particular category,
risk to that particular category is presumed to exist. Risk presumptions are
presented along with the corresponding LOCs.
Levels of Concern (LOC) and associated Risk Presumption
•m-itiM- iiiimirii i, iiii--iL-inifmu • % * % " % Mamftt«Is, Bitds , Y'i
IFTOE
acute RQ>
acute RQ>
1 acute RQ> |
; toe
" 0.5
0.2
0 1
i
s * r Fish.d
I LOC
0.5
-------
chronic RQ>
''••>• • Mamm»ls,flird<
IFTHE
RQ>
IOC
- 1
1
Plants
nically
PRESUMPTION ' \
4. Exposure and Risk to Nontarget Terrestrial Animals
a. Birds
Birds may ingest granules of the product Doo-Not. They may also
be exposed by other routes, such as dermal exposure when walking on top
of granules. The number of lethal doses (LDsos) that are available on one
square foot immediately after application is normally used to assess the
risk from such exposure. However, the available toxicity data are
inadequate for this approach because definitive LD50 values are not
available.
The only acceptable study on acute effects to birds used the
formulated product Doo-Not. This study determined only that Hie LD50 is
something greater than 2000 mg/kg. This information is inadequate to
assess quantitatively the risk of Doo-Not to birds.
Although the risk of furanones to avian species cannot be
quantified, several factors indicate that the risk is small. First, there was
no mortality or signs of toxicity to birds that received the relatively high
dose of 2000 mg/kg. Birds would need to consume more than 2000 mg/kg
of this product before toxic effects may be expected. This is a relatively
large quantity of granules for a bird to consume. Second, Doo-Not is
labeled for use on lawns and ornamental turf around homes. It is likely to
be applied only to small isolated areas. Any risk to birds that may result
would be small in terms of area exposed and number of birds affected
Third, the formulation repels mammals and insects, and thus is probably
somewhat repellent to birds as well. In conclusion, it is reasonable to ,
assume that normal use of this product would not cause sufficient exposure
' to birds to result in any significant ecological damage.
Birds also could be exposed to furanones if they drink from bodies
of water treated with Rodspray Mosquito Larvicide (Reg. No. 45987-6).
The EECs in water immediately following application of the mosquito
larvicide are not greater than 3.01 ppm (see section 3.a.2). In avian dietary
toxicity tests with Doo-Not, a product that contains the same
concentrations of furanones as the mosquito larvicide, the dietary LC50 for
21
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5.
both the bobwhite and mallard were greater than 5000 ppm. While there
is uncertainty associated with comparing the toxicity of different
formulated products and using a dietary toxicity test to assess the risk from
drinking contaminated water, the huge difference (>1000 fold) between the
EEC and the concentrations that may cause effects is large enough to
safely presume minimal risk from this type of exposure.
Other products that contain furanones are expected to result in
negligible exposure to birds. The Rodspray Fly, Cockroach, & Ant Killer
(Reg. No. 45987-2) is sold in a pump-spray bottle and is designed for
application to very small areas indoors and outdoor premises of domestic
dwellings. Homeowners would not be likely to use this product on wildlife
food. The other products are used as insect repellents and would not result
in exposure to birds.
b.
Mammals
Mammals may be exposed to furanones by consuming the granular
product Doo-Not Dog & Cat Repellent (Reg. No. 45987-1) and by
exposure to residues of the liquid product Rodspray Fly, Cockroach & Ant
Killer (Reg. No. 45987-2). An acute oral toxicity study with Doo-Not
showed that no mortality occurred at doses as great as 5000 mg/kg The
fly, cockroach, & ant killer product has the same concentration of
furanones as Doo-Not. Because of this apparent lack of toxicity of the
formulated products containing furanone, and because these formulations
repel mammals, it is anticipated lhat mammals will not be exposed to large
enough quantities to cause any significant ecological damage. The EECs
of the formulated product Rodspray mosquito larvicide are not expected
to exceed 3.01 ppm. This concentration is too small to cause any
appreciable risk to mammals that may drink treated water. The use pattern
of other products should not lead to any appreciable exposure to mammals
Thus, the currently registered products containing furanones pose minimal
risk to wild mammals.
c.
Insects
^ None of the products containing furanones are used in a manner
that is expected to cause any appreciable exposure to honey bees.
Exposure and Risk to Nontarget Aquatic Animals
With the exception of Rodspray Mosquito Larvicide (Reg No 45987-6)
all registered products containing furanones should pose very little exposure to
22
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aquatic organisms when used as directed. These products, which are for domestic
use only, are used to repel dogs and cats, repel insects from human skin, and kill
household insect pests. The dog and cat repellent use and insecticide use are for
spot treatment of very small areas around homes, such as compost piles and
garbage pails. Considering that me tpxicities of these formulations are at most
only slightly toxic to aquatic organisms, the risk they pose to aquatic organisms
is minute. The potential of exposure to aquatic organisms is much greater with the
mosquito larvacide use because it is applied directly to bodies of water
Furthermore, it is registered for public use as well as household use, and thus may
be applied to much larger areas than the other products. The risk that the
mosquito larvacide use poses to aquatic organisms is discussed in detail below.
Expected Aquatic Concentrations: The toxieity of furanones to aquatic
organisms is not known. However, data on the formulated product Doo-Not (Reg.
No. 45987-1) indicate that it is practically nontoxic to freshwater fish and slightly
toxic to freshwater invertebrates. This formulated product contains the same
concentration of furanones as the mosquito larvicide (0.024% dihydro-5-penryl-
2(3H)-furanone and 0.049% 5-heptvldihydro-2(3H)-furanone). Therefore, aquatic
risk will be assessed by comparing the expected environmental exposure to the
larvicide formulated product to the toxieity of the Doo-Not formulated product
This risk assessment approach is less than ideal because the larvicide contains an
additional active ingredient, mineral oil, as well as different inert ingredients than
Doo-Not.
The following table summarizes the EECs for the mosquito larvicide
Use Type
Use
Application
Method
Spray
Application Rate
1.64 Ib/A
(2gaI/A)
4.10 Ib/A
(5 gal/A)
Initial EEC (ppm)
6 inches
1.200
3.010
Ifoot
0.603
1.510
6 feet
0.100
0.251
6. Freshwater Fish
The following table summarizes the risk quotients (EEC/LC
-------
None of the acute RQs listed above exceed any of the LOCs.
Therefore, use of the mosquito larvicide containing furanones is presumed
to pose low acute risk to freshwater fish and to cause no appreciable acute
effects to endangered species.
As stated previously, use of the other formulated products
containing furanones are expected to result in very little exposure to
aquatic habitats, much less than the mosquito larvacide use described
above. Since the mosquito larvacide is presumed to pose low acute risk to
freshwater fish, the other uses are also presumed to pose low acute risk.
a. Freshwater Invertebrates
The following table summarizes the risk quotients (EEC/LC,0) for freshwater invertebrates
Crop/application rate
Mosquito Larvicide,
Domestic Use, 1.64 Ib/A
Public Health Use, 4.10 Ib/A
Species
Daphnia magna
Daphnia magna
0.071
0.18
fates , ,
Acute Risk Quotient
0.035
0.089
0.0059
0.015
None of the acute RQ's listed above exceed the LOG for high
acute risk. The acute level of concern for which restricted use may be
appropriate (0.1) are not exceeded for either use of the larvicide when the
depth of the water is 1 foot or greater. However, public health use of the
larvicide at the rate of 4.10 Ibs/A (5 gal/A) exceeds this LOG when applied
to 6 inches of water.
The level of concern for endangered species is also exceeded when
the product is applied at 1.64 Ib/A (2 gal/A) in water 6 inches deep or less
or when it is applied at 4.10 Ib/A (5 gal/A) in water 1 foot deep or less.'
These risk quotients are plausible, since mosquito larvicides are often
applied to shallow, stagnant water.
The risk quotients also suggest that some risk could be posed to the
aquatic stages of amphibians (e.g. tadpoles), although the extrapolation of
risk from aquatic invertebrates to amphibian larvae is highly uncertain.
It should be recognized that the risk posed to aquatic invertebrates
would be shared with most, if not all, products for this use. It is the nature
of mosquito larvicides to be harmful to aquatic invertebrates because the
target species is itself an aquatic invertebrate. The mosquito larvicide
containing furanone would cause less harm to aquatic ecosystems than
many other products because its risk is limited to aquatic invertebrates,
whereas others pose a risk to fish and birds as well. ,'
24
-------
Persistence of furanones in water or repeated applications of the
product could cause chronic exposure to furanones. A chronic freshwater
invertebrate toxicity study is needed to complete the aquatic risk
assessment.
As stated previously, use of the other formulated products
containing furanones is expected to result in very little exposure to aquatic
habitats, much less than the mosquito larvicide use described above A
high-risk scenario would be if 1% of the formulated product applied to a
1-acre lot runs off into a 1-acre pond. This scenario would result in
aquatic exposures approximately 100 times smaller than those for the
mosquito larvicide use. Since the mosquito larvicide generally is presumed
to pose low acute risk (except for the extreme case of application to 6
niches of water), the other uses are also presumed to pose low acute risk.
b. Endangered Species
When the Endangered Species Protection Program becomes final
limitations in the use of furanones may be required to protect endangered
and threatened species. These limitations have not been defined and may
be formulation specific. EPA anticipates that a consultation with the Fish
and Wildlife Service may be conducted in accordance with the species-
based priority approach described in the Program. After completion of
consultation, registrants would be informed if any required label
modifications are necessary. Such modifications would most likely consist
of the. generic label statement referring pesticide users to use limitations
contained in county Bulletins.
Use of the mosquito larvicide containing furanones (Reg. No
45987-6) may have harmful effects on endangered species of aquatic
invertebrates. The level of concern for endangered species are exceeded
when the product is applied at 1.64 Ib/A (2 gal/A) in water 6 inches deep
or less, or when it is applied at 4.10 Ib/A (5 gal/A) in water 1 sfoot deep or
less. In general, mosquito larvicide of any kind should not be applied to
stagnant or slow-flowing bodies of water that provide habitat for
endangered aquatic invertebrates. The two primary types of habitats that
are of concern are vernal pools in California and water that drains into
caves. The California state-initiative plan will protect species in vernal
pools. No federal protection is therefore required for these species as long
as the state-initiative plan continues to be implemented. Use of this
mosquito larvicide should be restricted around caves that harbor endemic
populations of endangered crayfish, shrimp, or other aquatic invertebrates
25
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Other than the possible effect of the mosquito larvicide to
endangered aquatic invertebrates, the use of products containing furanones
should not cause effects to endangered species.
IV. RISK MANAGEMENT AND REREGISTRAHON 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 data required to support registration of products
containing furanone as 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 furanone. Appendix B identifies the data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of furanone 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 furanone and to determine that furanone can be used without resulting
in unreasonable adverse effects to humans and. the environment provided the the
production cap is not exceeded. The Agency therefore finds that all products containing
ruranone 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
stadies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of furanone 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 furanone, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the furanone active
ingredients, the Agency has sufficient information on the health effects of furanone
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that furanone 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,
26
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the Agency concludes that all uses of products containing furanone are eligible for
reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of furanone are eligible for
reregistration.
C. Regulatory Position
«n. The following is a summary of the regulatory positions and rationales for furanone
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Mosquito Larvicide Use-Production Limit
The furanones, when used as mosquito larvicides, are applied directly to
water (residential and large scale public health use.) The public health larvicidal
use of furanones applied at 4.10 Ibs/A to 6 inches of water results in exceedances
of the level of concern for freshwater invertebrates: The LOG for endangered
species is exceeded when the product is applied at 1.64 Ib/A in water 6 inches deep
or less, or when it is applied at 4.10 Ib/A in water 1 foot deep or less This
assessment is based on testing done on a formulated product and tells little about
the actual toxicity of the furanones as active ingredients. Chronic invertebrate
toxicity data (life cycle test with a freshwater invertebrate) and basic environmental
fate data would improve the Agency's understanding and assessment of the
potential risk posed by the use the of furanones in mosquito larvicides.
The volume of furanone products used annually as mosquito larvicides is
low and the percentage of furanones in the product is also low. The low volume
and low percent furanones support the conclusion that widespread adverse impacts
are not likely to result from the mosquito larvicide use if continued at the amounts
currently produced and used (volume and percent furanone in product). The
Agency, in this RED document, is imposing a production limit on furanone for use
ma mosquito larvicide of 150 gallons furanone per year. Should the volume
produced and used and/or the percent of furanone in the product significantly
increase, the Agency may impose additional data requirements to understand and
assess potential risks.
It should be recognized that the risk posed to aquatic invertebrates is
common to most, if not all, products for this use. It is the nature of mosquito
larvicides to be harmful to aquatic invertebrates because the target species is itself
an aquatic invertebrate. The mosquito larvicide product containing furanones
would cause less harm to aquatic ecosystems than many other products because its
' • ' • ••':'• 27 ' '' .
-------
risk is limited to aquatic invertebrates, whereas others pose a risk to fish and birds
as well.
2. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
restrictions to protect endangered and threatened species at the county level
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses.
In the future, the Agency plans to publish a description of the Endangered
Species Program in the Federal Register. 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.
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 furanone for the
above eligible uses has been reviewed and determined to be substantially complete.
Environmental fate and chronic invertebrate toxicity data are not available
and are needed to complete the assessment of risks posed by the use of the
furanones as mosquito larvicides. However, the Agency is not requiring these data
as long as the product of furanone for this use does not exceed 150 gallons per
year. Should the volume produced and used and/or the percent of active ingredient
in the product significantly increase, the Agency may impose additional data
requirements to understand and assess potential risks.
28
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2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an [fill blank with Insecticide, Herbicide or the
applicable term which describes the type of pesticide use(s)] for the
following use(s) [fill blank only with those uses that are being supported bv
MP registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
"Directions for Use" to permit the reformulation of the product for
a specific use or all additional uses supported by a formulator or
user group:
(a)
(b)
"This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Effluent Discharge Labeling Statements
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
.prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office
of the EPA."
29
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
2. Labeling Requirements for End-Use Products
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 Nptice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements ( 4 0 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 those
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 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 any person.
30
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The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 £FR § 156.10 and other applicable
notices. ,
Effluent Discharge Labeling Statements
.\ •' ' • , . -
Refer to subsection A. above for labeling requirements for effluent
discharge.
C. Existing Stocks .
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of .the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell [add chemical
names here] 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.
31
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32
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VI. APPENDICES
33
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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 Furanone covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Furanone in all products, including
data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
-i . ' i
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 31 If the Agency has acceptable data in its files this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
40
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered
, are included. '
- 2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
. , • .atte.nipted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically-by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
"•49
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
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.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted..
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears'. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative positibn of the study within
the volume.
50
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BIBLIOGRAPHY
MRTO
CITATION
00077001
40543600
40543601
41864500
41864501
42380700
42380701
42678100
42678101
42678102
42678103
42678104
Monogram Industries, Incorporated (19??) Product Chemistry. (Unpublished
study received May 5, 1981 under 45987-1; CDL: 245189-A)
Rod Products Company (1988) Submission of Efficacy Data on Doo-Not (EPA
Reg. No. 45987-1). Transmittal of 1 study.
Rod, R. (1987) Doo-Not Test Procedure TP-109B: Efficacy Tests with Cats.
\ Unpublished study prepared by Connie's Kitty Castle. 13 p.
Rod Products Co. (1991) Submission of Products Chemistry Data to Support
the Application for Amended Registration of RodSpray Fly , Cockroach, and
Ant Killer Spray. Transmittal of 1 Study.
Rod, R. (1991) Subpart C-Produet Chemistry Data. Unpublished study
prepared by Rod Products Co. 58 p.
Rod Products Comp. (1992) Submission of Product Chemistry Data in Support
of Registration for Fly, Cockroach, and Ant Killer. Transmittal of 1 study.
Rod, R. (1991) Subpart C-Product Chemistry Data Requirements: Unpublished
study prepared by Rod Products Co. 58 p.
,Rod Products Co. (1993) Submission of product chemistry, toxicity, and
efficacy data to support Rodspray registration. Transmittal of 4 studies.
Rod, R. (1993) Subpart C: Product Chemistry: Rodspray Mosquito Larvicide.
Unpublished study prepared by Rod Products Co. 15 p.
Rod, R. (1993) Subpart D: Data Requirements Tables-Rodspray Mosquito
Larvicide. Unpublished study prepared by Rod Products Co. 10 p.
Rod,^R. (1993) Efficacy Study: Rodspray Mosquito Larvicide. Unpublished
study prepared by Rod Products Co. 23 p.
Kuhn, J. (1993) Rodspray: Acute Dermal Toxicity Study in Rabbits: Lab
Project Number: 9684-92. Unpublished study prepared by Stillmeadow me
lip. .
51
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BIBLIOGRAPHY
MRID
CITATION
42864100
42864101
43013700
43013701
43355000
43355001
93207000
93207001
93207002
93207003
93207004
Rod Products Co. (1993) Submission of efficacy data in support of registration
for Bugchaser Insect Repellent Strip. Transmittal of 1 study.
Rod, R. (1993) Efficacy Studies: Various Rodspray Products. Unpublished
study prepared by Rod Products Co. 14 p.
Rod Products Co. (1993) Submission of Efficacy Data in Support of
Application for Registration of BUGCHASER Insect Repellent Strip.
Transmittal of 1 Study.
Vargo, A. (1993) Efficacy Study: Bugchaser Wrist Band Insect Repellent Strip.
Unpublished study prepared by American Samoa Community College. 5 p.
Rod Products Co. (1994) Submission of Product Chemistry Data in Support of
Application for Registration of Rodspray IndoorOutdoor Crawling & Flying
Insect Killer. Transmittal of 1 Study.
Rod, R. (1994) Product Chemistry Data Requirements (Rodspray
Indoor-Outdoor Crawling & Flying Insect Killer). Unpublished study prepared
by Rod Products Co. 68 p.
Rod Products Company (1990) Reregistration Phase 3 Response: Furanone
dihydro-5-penryl(8CI,9CI). . '
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00077001
and Related MRIDs 00077002, 00077003. (Product Identity: Doo-Not). 8 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109340
Acute Avian Oral: Quail: No-Go Dog Repellent: ABSL No. 18766. Prepared
by Applied Biological Sciences Laboratory, Inc. 11 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109342
Acute Avian Diet.: Quail: No-Go Dog Repellent: ABSL No. 18866. Prepared
by Applied Biological Sciences Laboratory, Inc. 12 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109341
Acute Avian Diet. Duck No-Go Dog Repellent: ABSL No. 18866. Prepared by
Applied Biological Sciences Laboratory, Inc. 12 p.
. 52
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BIBLIOGRAPHY
MRID
CITATION
93207005
93207006
93207007
93207008
93207009
93207010
93207011
93207012
93207013
93207999
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109344
Fish Toxicity Fathead Minnows: No-Go Dog Repellent: ABSL No 18766
Prepared by Applied Biological Sciences Laboratory, Inc. lip.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109343
Fish Toxicity Rainbow Trout: No-Go Dog Repellent: ABSL No 18766
Prepared by Applied Biological Sciences Laboratories, Inc. 11 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109345
Invertebrate Toxicity: No-Go Dog Repellent: ABSL No. 18766. Prepared by '
Applied Biological Sciences Laboratories, Inc. 11 p.
s '• ' " ' ' ,'
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Acute Oral Toxicity Rat: Monogram Animal Repellant No, 100: Test Report
No. 1-2-27836-2. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Acute Dermal Toxicity Rabbit.. .Monogram Animal Repellant No 100 Test
Report No. 1-2-27836-1. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Acute Inhalation Toxicity Rat: Monogram Animal Repellant No 100- Test
Report No. 1-2-27836-4. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Primary Eye Irritation Rabbit: Monogram Animal Repellant No 100- Test
Report No. 1-2-27836-3. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Primary Dermal Irritation: Monogram Animal Repellant No. 100: Test Report
No. 1-2-27836-5. Prepared by Bio-Technics Laboratories, Inc. 10 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Dermal Sensitization: Monogram Animal Repellant No. 100: Test Report No
1-2-27836-6. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod Products Company (1990) Reregistration Phase 3 Response: Furanone
dihydro-5-pentyl(8CI,9CI). Correspondence and Supporting Material. '
53
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BIBLIOGRAPHY
MRBD
CITATION
93208000
93208001
93208002
93208003
93208004
93208005
93208006
Rod Products Company (1990) Reregistration Phase 3 Response:
Furanone,5-heptyldihydro-.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00077001
and Related MRIDs 00077002, 00077003. (Product Identity: Doo-Not). 8 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109340.
Acute Avian Oral Toxicity: No-Go Dog Repellent: Quail: ABSL No. 18766.
Prepared by Applied Biological Sciences Laboratory, Inc.. lip.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109342.
Acute Avian Diet. Toxicity: No-Go Dog Repellent: Quail: ABSL No. 18866.
Prepared by Applied Biological Sciences Laboratory, Inc. 12 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109341.
Acute. Avian Diet. Toxicity: No-Go Dog Repellent: Duck: ABSL No. 18866.
Prepared by Applied Biological Sciences Laboratory, Inc. 12 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109344.
Fish Toxicity Fathead Minnows: No-Go Dog Repellent: ABSL No. 18766.
Prepared by Applied Biological Sciences Laboratory, Inc. lip.
Rpd, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109343.
Fish Toxicity Rainbow Trout: No-Go Dog Repellent: ABSL No. 18766.
Prepared by Applied Biological Sciences Laboratories, Inc. lip.
93208007
93208008
93208009
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109345.
Invertebrate Toxicity: No-Go Dog Repellent: ABSL No. 18766. Prepared by
Applied Biological Sciences Laboratories, Inc. lip.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Acute Oral Toxicity Rat: Monogram Animal Repellant No. 100: Test Report
No. 1-2-27836-2. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products C9mpany Phase 3 Summary of MRID 00109339.
Acute Dermal Toxicity: Rabbit...(Monogram Animal Repellant No. 100): Test
Report No. 1-2-27836-1. Prepared by Bio-Technics Laboratories, Inc. 9 p.
54
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MRID
BIBLIOGRAPHY
CITATION
93208010
93208011
93208012
93208013
93208999
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Acute Inhalation Toxicity Rat: Monogram Animal Repellant No 100- Test
Report No. 1-2-27836-4. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R, (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Primary Eye Irritation Rabbit: Monogram Animal Repellant No 100- Test
Report No. 1-2-27836-3. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Primary Dermal Irritation: Monogram Animal Repellant No. 100: Test Report
No. 1-2-27836-5, Prepared by Bio-Technics Laboratories, Inc. 10 p.
Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339
Dermal Sensitization: Monogram Animal Repellant No. 100: Test Report No
.1-2-27836-6. Prepared by Bio-Technics Laboratories, Inc. 9 p.
Rod Products Company (1990) Reregistration Phase 3 Response:
Furanone,5-heptyldihydro-. Correspondence and Supporting Material.
55
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.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
GENERIC DATA CALL-IN NOTICE
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your produces)
containing this active ingredients). Within 90 days after you receive this Notice you must
respond as set forth in Section HI below. Your response must state:
1.
2.
3.
how you will comply with the requirements set forth in this Notice and its Attachments 1
through 4; or,
why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-BV
or>
why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section in-D).
If you do not respond to this Notice, or .if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
produces) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
56
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nHnnn>7fP?™0* Reducti™ Act by OMB Approval No, 2070-0107
and 2070-0057 (expiration date 3-31-96).
' ' ' "'"'''•',.'
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments ™
specific chemical information and instructions. The six sections of the Notice arT
Section I
Section II
Section IE
Section IV
Section V
Section VI
Why You Are Receiving This Notice
Data Required By This Notice
Compliarice With Requirements Of This Notice
Consequences Of Failure To Comply With This Notice
Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 -
Attachment 2 -
Attachments -
Attachment 4 -
Data Call-In Chemical Status Sheet
Data Call-in Response Form
Requirements Status And Registrant's Response Form
List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
j*. nH *** reViTd 6Xisting *"* for **• active ™gredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s) This r
identified additional data necessary to assess the health and safety of the continu J use
conning tins actrve ingredient(s). You have been sent this Notice because you have
containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
**" Notice are Specified in Attachment 3, Requirements
.S RfP°nse Form- De^ing on the results of the studied reqS
4^«=u
« . -
Notice, additional testing may be required.
57
-------
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
C. TESTING PROTOCOL .
All studies required under this Notice must be conducted in accordance with test
standards outlined1 in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel-
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from 2001 L Street, N.W., Washington, D.C. 20036 (Telephone number
202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D.
REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY : '
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-In(s). or any other agreements e.rxr.rM
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately respond
58
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to tins Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due
to failure to comply with this Notice are presented in Section IV-A and IV-B.
,B. OPTIONS FOR RESPONDING TO THE AGENCY
, x : for ^P011^ to A18 Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option the
Delete Use(s) option or the Generic Data Exemption option is presented below A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section m-D.
• \ ' ' '
There are two forms that accompany this Notice of which, depending upon your
response one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-in Response Form must he ..nh^ „
part of every response to this Notice, Please note that the company's authorized
representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form Of this form is required) and initial
any subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person identified in Attachment 1.
L Voluntary Cancellation - You mav avniH th» ^r*™^ nf thi;. Noticc b
requesting voluntary cancellation of your produces) containing the active
mgredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-in Response Form
indicating your election of this option. Voluntary cancellation is item number 5
*? ™ Data Call-in Response Form. If you choose this option, this is the only form
that you are required to complete.
,. *f. you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be iii
accordance with the Existing Stocks provisions of this Notice which are contained
in Section I V-C. ,
„, ' ' t ' ; ,
2 Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply If you wish
to amend your registration to delete uses, you must submit the Requirements Status
and Registrant's Response Form, a completed application for amendment a copy
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of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
Response Form by signing the certification, item number 8, Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
-1*"1 ' , '
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant
for registration of a product is exempt from the requirement to submit or cite
generic data concerning an active ingredient(s) if the active ingredients) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
soteiy because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredients) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation. The
Generic Data Exemption is item number 6a on the Data Call-In Response Form.
If you claim a generic data exemption you are not required to complete the
Requirements Status and Registrant's Response Form. Generic Data Exemption
cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with this
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c.
Data Call-in Notice, the Agency will consider that both they and you are not in
compliance and will normally initiate proceedings to suspend the registrations of
both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4' ... Satisfying the Data Requirements of this Notice - There are various options
available to satisfy the data requirements of this Notice. These options are
discussed in Section ffl-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Call-in Response Form. If you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5- • _ Request for Data Waivers. Data waivers are discussed in Section III-D of
tiiis Notice and are covered by options 8 and 9 on the Requirements Status and
Registrants Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy
f ^tion 6b and/or 7), then you must seL one o?£
Status ^d Registrant's Response Form related to data
n * Your 0Pti°n selection should be entered under item
, Registrant Respond " The six options related to data production are the fim
^options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are Led immediately below
to guide registrants t
1.
2.
3.
4.
I will generate and submit data within the specified time frame (Developing
v B
Data),
I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing), p
I have made offers to cost-share (Offers to Cost Share),
Tarn submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study),
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5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but.not reviewed by the Agency
(Citing an Existing Study).
Option 1, Developing Data -
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and in
the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section II-C. . If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the
date you are required to commit to generate or undertake some other means to
address that study requirement, such as making an offer to cost-share or agreeing
to share in the cost of developing that study. A 90-day progress report must be
submitted for all studies. This 90-day progress report must include the date the
study was or will be initiated and, for studies to be started within 12 months of
commitment, the name and address of the laboratory(ies) or individuals who are
or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
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completed study reports or protocols. The noted deadlines ran from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
_ If you cannot submit the data/reports to the Agency in the time required by
this Notice and intend to seek additional time to meet the requirement(s), you must
submit a request to the Agency which includes: (1) a detailed description of the
expected difficulty and (2) a proposed schedule including alternative dates for
meeting such requirements on a step-by-step basis. You must explain any technical
or laboratory difficulties and provide documentation from the laboratory
performing the testing; While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data ~
If you choose to enter into an-agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide the
name of the registrant who will be submitting the data. You must also provide
kPA with documentary evidence that an agreement has been formed Such
evidence may be your letter offering to join in an agreement and the other
registrant s acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms bfthe final arrangement between the parties or the mechanism to resolve the
terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of
the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development -
<" ' * • '
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration®, although you do not comply with the
data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of
a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer, To qualify for this option,
" -.' , _ / ^ . , • • ,_
-' '" • .- -.'" ' '•' '. 63 '''•'• ' ,
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you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data.
In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or
failing agreement to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required by
this Notice by submitting a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form committing to develop and submit the data
required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens pf developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for some
• other reason is subject to suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame.
In such cases, the Agency generally will not grant a time extension for submitting
the data. 6
Option 4, Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance
of this Notice. Do not use this option if you are submitting data to upgrade a
study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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a. You must certify at the time that the existing study is submitted that
the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be done
in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation
of the report of that study. In.the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact
transcript may be substituted for the original source as raw data. Raw data
may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term, "specimens", according to 40
CFR 160.3(7), means "any material derived from a test system for
examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control information
pursuant to the requirements of 40 CFR Part 160. Registrants must also
certify at the time of submitting the existing study that such GLP
information is available for post-May 1984 studies by including an
appropriate .statement on or attached to the study signed by an authorized
official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Registration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not.available for such studies.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is in the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study -
If a study has been classified as partially acceptable and upgradeable you
may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1, If you submit data to upgrade an existing
study you must'satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated -
as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded. ,
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
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.The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
. Option 6, Citing Existing Studies —
') , •' .': ' ' .- • ' - - < ^
If you choose to cite a study that has been previously submitted to EPA
that study must have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as "core-guideline" or "core minimum "
For ecological effects studies, the classification generally would be a rating of
"core." For all other disciplines the classification would be "acceptable " With
respect to any studies for which you wish to select this option you must provide the
MRID number of the study you are citing and, if the study has been reviewed by
the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter
you must submit a completed copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D- REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement® are inapplicable and do not apply to your product.
1 • „ Low Volume/Minor Use Waiver - Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume pesticides
only those active ingredients) whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use
waiver the Agency will consider the extent, pattern and volume of use the
economic incentive to conduct the testing, the importance of the pesticide and the
exposure and risk from use of the pesticide. If an active ingredient(s) is used for
both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredients) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to requests
for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredients). If applicable to the active
ingredients), include foreign sales for those products that are not registered
in this country but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information by year for
each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of produces) containing the active
ingredients) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to produces) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient®, such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of Xyaiver sought and the estimated.cost to you (listed
separately for each data requirement and associated test) of conducting the
testing needed to fulfill each of the'se data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and assoqiated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of produces) containing the active ingredients) (following .the
parameters in item c above), indirect production costs of produces)
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containing the active ingredients)' (following the parameters in item d
above), and costs of data development pertaining to the active ingredient(s).
„ h. A description of the importance and unique benefits of the active
ingredient® to users. Discuss the use patterns and the effectiveness of the
active mgredient(s) relative to registered alternative chemicals and
- non-chemical control strategies. Focus on benefits unique to the active
mgredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredients)
in Integrated Pest Management, (b) description of the beneficial impacts on
-the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
mgredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the reauest
for a waiver. 4
^ v Bequest for Waiver of Data -Option 9 on the Requirements Status and
Registrant s Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
, longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must also
submit the current label(s) of your produces) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
* • . , '' '
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
l^S\?™ Wm n0t * required to "Wfr ** data Pursu*nt to section
3(c)(2)(B). If EPA determines that the data are required for your product^ you
must choose a method of meeting the requirements of this Notice witMnlhetime'
frame provided by this Notice. Within 30 davs nf y™.r r^0;pt rf the Agency':
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosei^: •
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1.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
Failure to respond as required by this Notice within 90 days of your receipt
of this Notice. ,
Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
Failure to submit on the required schedule acceptable data as required bv
this Notice.
Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing studies
or offers, arrangements, or arbitration on the sharing of costs or the
formation of Task Forces, failure to comply with the terms of an agreement
or arbitration concerning joint data development or failure to comply with
any terms of a data waiver).
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
Failure of the registrant to whom you have tendered an offer to share in the
cost of developing data and provided proof of the registrant's receipt of
such offer, or failure of a registrant on whom you rely for a generic data
exemption either to:
a. inform EPA of intent to develop and -submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form; or,
4.
5.
6.
7.
8.
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by this
t0 devel°P and subm* the data as required
c. 1 otherwise take appropriate steps to meet the requirements stated n
mis Notice unless you commit to submit and do submit the required data
in the specified time frame.
in
L tiJf T ^ reqUre °r aPPr°Priate ^ps, not mentioned above at
any time following the issuance of this Notice.
B.
' v determine ** a study (even if submitted within the required
is unacceptable and constitutes a basis for issuance of a Notice of Ment to
1. KFA iemiii»m»nta on~.;*^ h me Dflta ^jj^ Notice ^
Dab R«vwti ^ r""ng' aS applicable' EPAPesticiae Assessment
., Data Reporting Guidelines, and GeneTox Health Effects Test
regarding the design, conduct, and reporting of required studies Such
include, but are not limited to, those relating to test material, test
selection of species, number of animals sex and diotrihntion nt
animals dose and effect levels to be tested or attained', duration of Stand as
applicable, Good Laboratory Practices. '
2. EPA requirements regarding the submission of protocols includine the
incorporation of any changes required by the Agency folLkg revSw g
nf r, ^A re2uiremeif re£arding U» ^porting of data, including the manner
of reporting, the completeness of results, and the adequacy of anv reouhS
suonort™ (^ r^ A^ ^^^ but ^ ^^ ^ .ieq^a£ SeSor
i final re ! rt- a^mtofai111 ?R 86"5' •M Studies must be submitted in
i requirement. 1 ere o fulfill the
C- EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or caSdSdo^g so
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would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their, sale, distribution, and use. Unless you meet
this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your produces) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless y°u demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS ~——
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
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whatever spurce, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
M *• If y?" ^ ^ questions regarding the .requirements and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-in Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
pMff ompliance (°C> of ** Office of Enforcement and Compliance Assurance
, EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregistration Division
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FURANONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have produces)
containing Furanone.
.. Generic Data Call-in Chemical Status Sheet, contains an overview nf data r^r**
by this notice, and point of contact for inquiries pertaining to the reregistration of Furanone This
attachment is to be used in conjunction with (1) the Generic Data Call-in Notice, (2) the Generic
Data Call-in Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 2), (4) a list of registrants receiving this DCI (Attachment 4) (5) the EPA
Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms in
replying to this Furanone Generic Data Call In (Attachment F). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Furanone
•are contained in the Requirements Status and Registrant's Response. Attachment C The Agency
has concluded that additional product chemistry data on Furanone are needed These data are
needed to fully complete the reregistration of all eligible Furanone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
- ur ? /u" 5*Ve 3ny Questions regarding the generic data requirements and procedures
established by this Notice, please contact Emily Mitchell at (703), 308-8583.
All responses to this Notice for the generic data requirements should be submitted to:
Emily Mitchell, Chemical Review Manager
Planning and Reregistration
Special Review and Registration Division (H7508W)
Office of Pesticiafde Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Furanone - ,
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
1 ! '
, This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
' ' • ' , - '"
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by
the registrant as appropriate Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of informationincluding suggesting for reducing this burden, to Chief, Information Policy
•522?A^ I vHrS Enjironmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107
Washington, D C 20503. '
INSTRUCTIONS
Item 1.
- Item 2.
ItemS.
Item 4.
Item 5.
This item identifies your company name, number and address.
This item identifies the ease number, ease name, EPA chemical number
and chemical name.
This item identifies the date and type of data call-in.
This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the,Agency's attention within the
period required for submission of this response form.
Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is'voluntarily
cancelled.
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Item 6a.
Item 6b.
Item 7a.
Item 7b.
Item 8.
Item 9.
Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this'item
for all products listed on this form If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Check this Item if the data calHn is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates how
you will satisfy those requirements.
Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
requirements. , • '.
This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Enter the date of signature.
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form, is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements. -
EPA has developed this form individually for each data call-in addressed to each registrant and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information Send
comments regarding the burden estimate or any other aspect of this collection of information
including suggesting for reducing this burden, to Chief, Information Policy Branch PM-223
J;«r Z™™01*™^ Protection Agency, 401 M St., S.W., Washington, D.C. 20460; 'and to the
Office of Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
£\J3\JJ
INSTRUCTIONS
Item 1 . This item identifies your company name, number, and address.
Item 2.
Item 3.
Item 4.
Item 5.
This item identifies the case number, case name, EPA chemical number and
chemical name.
This item identifies the date and type of data call-in.
This item identifies the guideline reference numbers of studies required to support
the produces) being reregistered/These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
\
This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
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Item 6.
submitted in connection with the study. As noted in Section III of the Data Call-in
Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and Registrant's
Response Form. •.".."
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food \
Indoor non-food
Indoor medical
Indoor residential
- Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP *
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
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TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
DEGR
*See: guideline comment
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient
and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
Degradates
Item 8.
Item 9.
This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-in Notice.
Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of these options.
L
(Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
the conditions for submittal of this study as outlined in the Data Call-In
Notice and that I will provide the protocol and progress reports required in
item 5 above.
1.
2.
3.
(Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-in
Notice.
(Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
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Item 10.
4. (Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option
I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In Notice
and I have attached the needed supporting information alone with this
• - response. . : ' . ' -
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data.to upgrade a study described in the Data Call-in Notice I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
(Deleting Uses) I am attaching an application for amendment to my
Registration deleting the uses for which the data are required.
(Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-in Notice
and I request a low-volume minor use waiver of the data requirement I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing the
data requirement as stated in the Notice governs.
(Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things
all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the
Notice governs.
This item must be signed by an authorized representative of your company The
person signing must include his/her tide, and must initial and date all other pages
or this rorm.. ,
7.
8.
9.
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Item 11.
Item 12.
Enter the date of signature.
Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
82
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet to
submit certain product specific data as noted herein to the U.S. Environmental Protection '
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your produces) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section HI below. Your response must state-
1.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form (see
section III-B); or ~~ ~—;—
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section IH-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your produces) subject to this Notice will be subject to suspension. We have provided a list of
•', 85
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all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6). '
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the. Paperwork Reduction Act by OMB Approval No 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I -
Section II -
Section HI -
Section IV -
Section V -
Section VI -
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This Notice
Consequences Of Failure To Comply With This Notice
Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION H. DATA REQUIRED BY THIS NOTICE
H-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additiorial testing may be required.
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H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided. : "
n-C, TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158 JO). When using the
OECD protocols,, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323: Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
n-P- REGISTRANTS RECEIVING PREVIOUS SECTION 3fc)(2)ffi) NOTICES
ISSUED BY THE AGENCY~~ : ~
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Dafa"Call-In(s). or any other agreements entered intn with £
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTIONm; COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE -
m-A. SCHEDULE FOR RESPONDING TQ THE AGENCY
' " r *• ' '
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
HI-B. OPTIONS FOR RESPONDING TO THE AGENCY
- 87
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
A discussion of how to respond if,you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of options
relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-In Response Form, and the Requirements Status and Registrant's Response Form,
Attachment 2 and Attachment 3. The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and
Registrant's Response Form must be submitted for each product listed on the Data Call-In
Response Form unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response Form in
Attachment 2). Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If
you have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is the
subject of this Notice. If you wish to voluntarily cancel your product, you must submit a
completed Data Call-In Response Form, indicating your election of this option. Voluntary
cancellation is item number 5 on the Data Call-In Response Form. If you choose this option,
this is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C. '
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section ni-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not~valfd
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form. If you choose one of these options, you must submit
88
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both forms as well as any other information/data pertaining to the option chosen to address the
data requirement.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
' , ' . ' '
.If you acknowledge on the Data Call-in Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under item
number 9, Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant s Response Form. These six options are listed immediately below with information
m parentheses to guide registrants to additional instructions provided in this Section The
options are: '
(1)
(2)
(3)
(4)
(5)
(6)
I will generate and submit data within the specified time frame (Developing
Data) °
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing) v
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citine an
Existing Study) 6
rnnfn Option 1; Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports The
noted deadlines run from the date, of the receipt of this Notice by the registrant. If the data are
not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
_ If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements^), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis
You must explain any technical or laboratory difficulties and provide documentation from'the
laboratory performing the testing. While EPA is considering your request the original
89 ,
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deadline remains. The Agency will respond to your request in writing. If EPA does not grant
your request, the original deadline remains. Normally, extensions can be requested only in
cases of extraordinary testing problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90:day responses. Extensions will not be
considered if the request for extension is not made in a timely fashion; in no event shall an
extension request be considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data -- Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you
choose to enter into an agreement to share in the cost of producing the required data but will
not be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may
resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development -- This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
the requirements of this Notice and have been unsuccessful, you may request EPA (by selecting
this option) to exercise its discretion not to suspend your registration(s), although you do not
comply with the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the registration of a
product of a registrant who has in good faith sought and continues to seek to enter into a joint
data development/cost sharing program, but the other registrant(s) developing the data has
refused to accept your offer. To qualify for this option, you must submit documentation to the
Agency proving that you have made an offer to another registrant (who has an obligation to
submit data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment 7. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into a cost sharing
agreement by including a copy of your offer and proof of the other registrant's receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to
share in the burden of producing the data upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iji) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop
and submit the data required by this Notice by submitting a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form pommitting to develop and submit the
data required by this Notice.
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In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate issuance of
this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
You should be aware that if the Agency determines that the study is not acceptable the
Agency will require you to comply with this Notice, normally without an extension of the'
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study all of the
following three criteria must be clearly met: —~ ~
a. You mus,t certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) reguktion, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data1 means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments.". The term "specimens", according to 40 CFR
160,3(k), means "any material derived from a test system for examination or
analysis." , " •
b.
Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
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c.
You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe
the study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files you must
submit a summary and copies as required by PR Notice 86-5.
J Option 5, Upgrading a Study - If a study has been classified as partially acceptable and
upgradable you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental
However, it is important to note that not all studies classified as supplemental are upgradeable
If you have questions regarding the classification of a study or whether a study may be
upgraded, call or write the contact person listed in Attachment 1. If you submit data to
upgrade an existing study you must satisfy or supply information to correct all deficiencies in
toe study identified by EPA. You must provide a clearly articulated rationale~of how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable
to UFA. Your submission must also specify the MRID nurnber(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded
,92
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The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended jo upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6, Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA, that study must have been previously classified by EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum."
For all other disciplines the classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements. '.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
m-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be
the only opportunity to state the reasons or provide information in support of your request. If
the Agency approves your waiver request, you will not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
Agency would grant a waiver only under extraordinary circumstances. You should also be
aware that submitting a waiver request will not automatically extend the due date for the study
in question. Waiver requests submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant
' • ' '••"•' ' .. ••'."". 93 ' . '
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to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
> ' ' ' •. • ~
Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
Failure to submit on the required schedule acceptable data as required by this
Notice.
Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required actioji or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section HI-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
fulfill the commitment to develop and submit the data as required by this
Notice; or
otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in
the specified time frame.
Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
b.
c.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE : :
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
. 1- EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of.
reporting, the completeness of results, and the.adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission requirement.
!V-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended produces) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You must also explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell
distribute, or use existing stocks. Normally, the Agency will allow persons other than'the
• ''•"'''< 95 ' ' ' ' '
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registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the Agency granting any additional time to sell, distribute or
use existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA will
consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS ~
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
XT • If you,_have my Questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet. . : :
96
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be
submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation or
generic data exemption option is chosen, only the Data Call-In Response Form need be
submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
\
5 -
6 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form " : "~ ' ~
97
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98
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FURANONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have produces)
containing Furanone. . w
. Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Furanone This attachment is to be used in conjunction with (1) the Product Specific Data Call-in
Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2) (3) the
Requirements Status arid Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and
T?^ « ? Share and Data Compensation Forms in replying to this Furanone Product Specific
Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Furanone are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on Furanone are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Furanone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
c* ur u ?uestions regarding this product specific data requirements and procedures
established by this Notice, please contact Emily Mitchell at (703) 308-8583.
Afl responses to this Notice for the Product Specific data requirements should be submitted
Emily Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508 W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Furanone
99
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4.
Item 5.
Item 6.
Item 7a.
Already completed by EPA.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you win not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if
your prdduct is identical to another product and you qualify for a data exemption
you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide
the EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such
products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b.
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition/on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
100
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3
Item 4.
Item 5.
Item 6.
Item?.
Item 8.
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-in Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
The study tide associated with the guideline reference number is identified.
The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns
are covered by the data requirements. In the case of efficacy data, the required
studies only pertain to products which have the use sites and/or pests indicated.
The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in'rare
cases.
The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Registration Eligibility Document unless EPA
determines that a longer time period is necessary.
Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained hi the Data Call-In Notice.
I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data and only
if EPA indicates in an attachment to this Notice that my product is similar enough
to another product to qualify for this option. I certify that another party in the
102
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5.
agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share hi the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am including a copy of my offer and proof of the other registrant's receipt
of that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
I certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I have
indicated this choice. By the specified due date, I will also submit a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) to show what data compensation option I have chosen. By the
specified due date, I will also submit: (1) a completed "Certification With '
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this
option outlined Option 5 in the Data Call-In Notice (Section IH-C. 1.) apply. By
the specified due date, I will also submit: (1) a completed "Certification With
103
-------
6.
7.
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or
Accession number(s) for the cited data on a "Product Specific Data Report" form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations'
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit- (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
104
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• GUIDELINE REQUIRE
FOOTNOTES AND KEY DEFINITIONS FOR
Tanol derivs.
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Les.]; TEP - typical end-use product ;TGAI . technical grade of the act
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N - Indoor Medical
REQUIREMENTS STATUS AND REGIS
1 crop - B - Terrestrial food feed crop c - Terrestrial nonfo.
Industrial G - Aquatic nonfood residential H - Greenhouse food c]
loor L - Indoor f°°<* M - Indoor nonfood
: following notes are referenced in column two (5. Study Title) of the
e Categories Key:
A - Terrestrial food
F - Aquatic nonfood
K - Residential outc
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will be required on a case-by-case basis.
re not required for inert ingredients in products proposed for experim
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reported. Refer to PR Notice 92-5 for more information.
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or under conditions of use will result in, an inha
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Instructions for Completing the Confidential Statement of Formula
domrf The Con?dential Statement of Formula (CSF) Form 8570-4 must be used Two legible
signed copies of the form are required. Following are basic instructions: § '
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c.
d.
e.
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must be provided.
the telephone number of the responsible party
''.••, '
is on the product specific
be in
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12. CUITe™y
M Ce (CAS) Numbers for •" actives
common names for the trade names must be reported.
and all
Ve ™8redients' **<* percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
^eTWei8htS " C°^mnS 13'a- "^ 13'b- must be in Po^ds, kilograms or
grams. In no case will volumes be accepted. Do not mix Enghsh afd metac
system units (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
4'a- -"d 14'b- f°rtheactive ^redients must represent
for ail active and inert ingredients must follow
aro^-^P **u _, ^ emanation must be provided if the proposed
are different than standard certified limits.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation. "omraea c&*s
112
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113
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114
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&EPA
United Statas Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB Mo. 2070-01 OS
2fl7n-nns7
Approval Expire* 3-31-9A
PubEc reporting burden for this coSection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection ol information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief. Information Policy
Branch, PM-223. U.S. Environmental Protection Agency. 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Pleasa .fill in blanks below. .
Company Nume
Compny Number
Product Mune
EPA RcE.No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Ad (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop Jointly or share in the cost of developing
data. - " ' . .. - . '
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B}(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Him* of Flrm(»)
Oil* of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form andaU attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'* Authorized Repreaentatlve
Date*
Name and Title (Please Type or Print)
EPA Form 8570-32 (»91) Replaces liFA form 8580, wMch Is obsolete
115
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116
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, includirig time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
* " , ' '
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Roderiticide Act
• (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
, data submitter to cite that study.
2, That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(°)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants'Response Form,"
3. That I have previously complied with section 3(c)(1 )(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature '
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1 )(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
rA rOOTl oo/u-ol (4-yt>;
117
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~on follpw?.g 5 a K* of av^able documents for Furanone that my further assist you in
E%ibi% Decision
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special Review
and ^registration Information System at 703-308-7224. They also are available
on the Internet on EPA's gopher server, GOPHER.EPA.GOV or usine fto on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW EPAGOV or
contact Emily Mitchell at (703)-308-8583. w.cr/v.uuv., or
. 1.
PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Furanone.
included M
mcluded in
PAnp °L** Administrative Record for Furanone and may
EPA s Office of Pesticide Programs Public Docket. Copies of these documents
a' but may be obtained by contacting
1. Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
nhto /Ollowf g .Agencv reference documents are not available electronically but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document
1.
2.
The Label Review Manual.
EPA Acceptance Criteria
118
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