United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-Q3Q
November 1956
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
S-Kinoprene
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 4117, S-Kinoprene.
S-Kinoprene is a biochemical pesticide which is chemically
synthesized and used as an insect juvenile hormone analog on indoor rion-
food/non-feed crops, including ornamental plants grown in greenhouses and
interiorscapes. S-Kinoprene, applied at a low rate, inhibits normal insect
growth during the molting process causing morphogenic, ovicidal, and
sterilization effects. When applied at a higher rate, S-Kinoprene kills the
adult populations of insects such as aphids, whiteflies, mealybugs, fungus
gnats, and armored scales. Since S-Kinoprene is used on non-food/non-
feed crops, a food tolerance establishment/exemption is not an issue.
Formulations include the technical grade active ingredient (TGAI) of
89% synthetic S-Kinoprene and 11% related impurities. The only end-use
product, Enstar®E (EPA Reg. No. 55947-82) consists of 65.1% TGAI and
34.9 inert ingredients.
S-Kinoprene is applied to 3,200 acres of ornamental plants in
greenhouses and interiorscapes with 70% total usage in the States of
California and Texas.
S-Kinoprene is not to be used through any type of irrigation system.
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Regulatory
History
Human Health
Assessment
S-Kinoprene was first registered as a pesticide in the U.S. in 1975
under the trade name Enstar®5E, and renamed Enstar®n, (EPA Reg. No.
55947-82) for use as an insecticide on indoor non-food/non-feed crops
grown in greenhouses and nurseries. A Data Call-In was issued on
September 30, 1993 to Sandoz Agro, Inc., the registrant for S-Kinoprene,
requiring additional toxicity data to satisfy the genotoxicity requirement.
Case No. 4117 also consists of R-S-Hydroprene (488300), andR-S .
Kinoprene (107501) which are no longer supported by the registrant. ,
S-Hydroprene (128988) was registered in 1986. This decision includes a
comprehensive reassessment of the required target data and the use patterns
of the currently registered product.
Toxicity
Adequate mammalian toxicology data are available to support
reregistration of the active ingredient S-Kinoprene, and will support a
Reregistration Eligibility Decision (RED)
Dietary Exposure
The uses of S-Kinoprene do not require a tolerance or an exemption
from tolerance, and dietary exposure from the uses of S-Kinoprene is
unlikely. Acute exposure from the proposed greenhouse and indoor use site
may occur, but would be very low because of the low application rates.
On August 3, 1996, the food Quality Act of 1996 (FQPA) (Public
Law 104-170) was signed into law. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA) 21, U.S.C. 301 et. seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C 136 et seq.
The FQPA amendments went into effect immediately. Among other things,
FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances, but FQPA does not obligate the Agency to
consider the factors set forth in the new section 408 of the FFDCA when
making decisions under FIFRA with respect to pesticides that do not have
any food uses. However, the FQPA did not am end any of the existing
reregistration deadlines in section 4 of FIFRA.
EPA is embarking on an intensive process, including consultation
with registrants, States, and other interested stakeholders, to make decisions
on the new policies and procedures that will be appropriate as a result of
enactment of FQPA. This process is likely to include an examination of
whether the same or a similar safety standard should apply to non-food
pesticide applications. Such a standard might include exposure of infants
and children to the pesticide(s), cumulative effects on infants and children
from this pesticide and other substances that have a common mechanism of
toxicity, and aggregate exposure of the population and major subgroups of
the population of the pesticide and related substances. The Agency has not
yet determined with finality how it will make such decisions. However, in
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Environmental
Assessment
light of the unaffected statutory deadlines with respect to reregistration, the
Agency will continue its ongoing reregistration program while it continues
to determine how best to implement FQPA.
In deciding to continue to make reregistration determinations during
the early stages of FQPA implementation, EPA recognizes that it will be
necessary to make decisions relating to FQPA before the implementation
process is complete. In making these early, case-by-case decisions, EPA
does not intent to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.
If EPA determines, as a result of this later implementation process,
that any of the determination described in this RED are no longer
appropriate, the Agency will consider itself free to pursue whatever action
may be appropriate, including but not limited to reconsideration of any
portion of this RED.
Available data indicate that residues of S-Kinoprene do not
concentrate in processed food or feed; therefore, no food or feed additive
tolerances are established or required.
Occupational and Residential
Based on the application methods, the potential for dermal eye, and
inhalation exposures to S-Kinoprene for pesticide handlers and applicators
exist. Because of the lack of significant mammalian toxicity, worker
exposure data (i.e., occupational exposure data) to the active ingredient are
not required at this time. However, due to the primary eye irritation
response (Toxicity Category El) the Agency will require the appropriate
Signal Word (Caution and Statements of Precaution (Causes slight eye
irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap
and water after handling).
Based on the use sites, use patterns, application method, and use rates,
the potential exposure to humans, including infants and children, is
negligible.
All ecological toxicity and environmental fate data requirements have
been adequately satisfied according to the guidelines set forth in 40 CFR
158.690 for biochemical pesticides for non-food/non-feed use.
Ecological Toxicity Data
In the Phase IV review of S-Kinoprene, the Ecological Effects Branch
(EEB), Environmental Fate and Effects Division (EFED), waived all non-
target data requirements because "Based on the use patterns, exposure to
non-target organisms is expected to be non-existent or negligible." (March
30, 1993 Memorandum from Anthony F. Maciorowski to Bruce Sidwell).
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Additional Data
Required
Product Labeling
Changes
Required
An aquatic invertebrate toxicity study involving Daphnia recently has been
submitted under FIFRA 6(a)(2). All data requirements for S-Kinoprene
have been adequately fulfilled; no additional studies are required for these
uses.
Environmental Fate
In the Phase IV review of S-Kinoprene, the Environmental Fate and
Ground-water Branch (EFGWB) in the Environmental Fate and Effects
Division, did not require any Environmental Fate data for S-Kinoprene
based on the use-patterns and low application rates (May 15, 1993
Memorandum from E. Brinson Conerly-Parks to Bruce Sidwell). Currently,
Environmental Fate data are not required for biochemical pesticides unless
effects in Tier I non-target studies indicate fate studies would be needed (40
CFR 185.690).
Exposure and Risk Characterization
S-Kinoprene was considered "highly toxic" to Daphnia Magna.
However, water insoluble material like S-Kinoprene might cause adverse
effects to Daphnia based on the inherent design of the toxicity study
(Guideline 154B-9). Since the use of S-Kinoprene is limited to
greenhouses and interiorscapes and such use patterns are not expected to
pose a significant risk to aquatic invertebrates, environmental fate studies
will not be required. Rather, any potential effects will be further mitigated
by including label language "do not contaminate water, food or feed by
storage or disposal."
The generic data base supporting the reregistration of S-Kinbprene for
the above eligible uses has been reviewed and determined to be
substantially complete. Therefore, there are no further generic data
requirements being imposed at this time.
The labels and labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR 156.10 and
other applicable notices.
Use Sites: Registrants must specify on labeling the complete directions for
use for each use pattern.
Application Rate: All labels must give specific maximum application rate,
type of application, timing of application, equipment used for application,
the rate of application (dosage), and maximum application rate.
Non-Food/Non-Feed Use: In conformity with S-Kinoprene's non-
food/non-feed use, labels should read: "Do not contaminate water, food, or
feed by storage or disposal."
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Regulatory
Conclusion
For More
Information
The registrant must submit five (5) copies of the updated labeling and
the updated Confidential Statement of Formula for each registered product.
Based on the reviews of the generic data for the active ingredient
S-Kinoprene, the Agency has sufficient information on the health effects of
S-Kinoprene and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency has determined that
S-Kinoprene products, labeled and used as specified in this Reregistration
Eligibility Decision, will not pose unreasonable risks or adverse effects to
humans (including infants and children) or to the environment. Therefore,
the Agency concludes that for products containing S-Kinoprene, all uses are
eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for S-Kinoprene during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the S-Kinoprene RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. '
For more information about EPA's pesticide reregistration program,
the S-Kinoprene RED, or reregistration of individual products containing
S-Kinoprene, 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
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
SEP 30 £96
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 S-Kinoprene
which includes the active ingredient 2-propynyl-2E, 4E-3,7,1 l-trimethyl-2-4-dodecadienoate.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of this chemical, 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 this product for reregistration. It may also include requirements for
additional data (generic) on the active ingredient 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 regarding the specific labeling requirements or wish to meet
with the Agency, please contact the Biopesticides and Pollution Prevention Division
Representative Beverly Sjoblad at (703) 308-8376.
Sincerely yours,
fir Janet L. Andersen, Director
Biopesticides and Pollution
Prevention Division
Enclosures:
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD 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/DCI letter; otherwise, your product
may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-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 8570-1) Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in
item 5.
b- Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the
RED and current regulations (40 CFR 156.10) and policies. Submit any other
amendments (such as formulation changes, or labeling changes not related to
reregistration) separately. You may, 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).
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c. Generic or Product Specific Data. Submit all data in a format which
complies with PR Notice 86-5, and/or submit citations of data already submitted and
give the EPA identifier (MRID) numbers. Before citing these studies, you must make
sure that they meet the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic
and each alternate formulation. The labeling and CSF which you submit for each
product must comply with P.R. Notice 91-2 by declaring the active ingredient as the
nominal concentration. You have two options for submitting a CSF: (1) accept the
standard certified limits (see 40 CFR §158.175) or (2) provide certified limits that are
supported by the analysis of five batches. If you choose the second option, you must
submit or cite the data for the five batches along with a certification statement as
described in 40 CFR §158.175(e). A copy of the CSF is enclosed; follow the
instructions on its back.
e. Certification With Respect to Data Compensation Requirements.
Complete and sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD/BPPD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
Bv express;
Document Processing Desk (RED-SRRD/BPPD-PRB)
Office of Pesticide Programs (75 04C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which
are not complete will be returned with a request for corrections. EPA will try to respond to
data waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
S-KINOPRENE
LIST D
CASE 4117
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
KINOPRENE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY : v
I. INTRODUCTION i
H. CASE OVERVIEW 3
A. Chemical Overview 3
B. Use Profile . ........... .3
C. Estimated Usage of Pesticide . . . 4
D. Data Requirements 5
E. Regulatory History 5
HI. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 7
1. Toxicology Assessment 7
2. Human Risk Assessment 9
C. Environmental Assessment 10
1. Ecological Toxicity Data 10
2. Environmental Fate 10
3. Exposure and Risk Characterization . . 11
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 11
A. Determination of Eligibility . . 11
B. Determination of Eligibility Decision 12
1. Eligibility Decision 12
2. Eligible and Ineligible Uses 12
C. Regulatory Position 12
1. Tolerance Reassessment 12
2. Endangered Species Statement 13
3. Labeling Rationale 13
V. ACTIONS REQUIRED OF REGISTRANTS 14
A. Manufacturing-Use Products 14
1. Additional Generic Data Requirements 14
2. Labeling Requirements for Manufacturing-Use Products 14
B. End-Use Products 14
1. Additional Product-Specific Data Requirements 14
2. Labeling Requirements for End-Use Products 15
C. Existing Stocks 15
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VI. APPENDICES .
APPENDIX A.
APPENDIX B.
APPENDIX C.
APPENDIX D.
17
Table of Use Patterns Subject to Reregistration 19
Table of the Generic Data Requirements and Studies
Used to Make the Reregistration Decision 23
Citations Considered to be Part of the Data Base
Supporting the Reregistration of S-Kinoprene 27
List of Available Related Documents 31
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KINOPRENE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Edward Brandt
William Gross
Tom Harris
Biopesticides and Pollution Prevention Division
Frank W. Ellis, Jr.
J. Thomas McClintock
Willie Nelson
Roy D. Sjoblad
Freshteh Toghrol
Special Review and Reregistration Division
Beverly W. Sjoblad
Economic Analysis Branch
Biological Analysis Branch
LUIS
Registration Branch
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ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LC«
LD,
LEL
LOC
LOD
LOEL
MATC
MCLG
mg/L
MOB
MP
MPI
MRID
N/A
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, non carcinogenic health effects are not
anticipated to occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
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
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q", The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency has completed its comprehensive
reassessment of the required target data and the use patterns of the currently registered
product containing S-Kinoprene (Shaughnessy Number 107502, Case No. 4117). Kinoprene
was registered in 1975, and the S-isomers will be the only active ingredient discussed in this
document. Case 4117 also consists of R-S Hydroprene (Shaughnessy Number 488300), and
R-S Kinoprene (Shaughnessy Number 107501) which are no longer being supported by the
registrant. Products containing S-Kinoprene will be eligible for reregistration upon the
publication of this document.
S-Kinoprene is a biochemical pesticide which is chemically synthesized and used as
an insect juvenile hormone analog on indoor non-food/non-feed crops, including ornamental
plants grown in greenhouses and interiorscapes. S-Kinoprene, applied at a low rate, inhibits
normal insect growth during the molting process causing morphogenic, ovicidal, and
sterilization effects. When applied at a higher rate, S-Kinoprene kills the adult populations of
insects such as aphids, whiteflies, mealybugs, fungus gnats, and armored scales. Since
S-Kinoprene is used on non-focid/non-feed crops, a food tolerance establishment/exemption is
not an issue.
The Agency believes that this use pattern does not present unreasonable risks to
humans, including infants and children, or to the environment, due to the low mammalian
toxicity, lack of dietary exposure, and low application rate. Also, the indoor use pattern
eliminates the potential for exposure to birds, fish, aquatic organisms, plants, and non-target
insects.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21, U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among
other things, FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances, but FQPA does not obligate the Agency to consider the factors
set forth in the new section 408 of the FFDCA when making decisions under FIFRA with
respect to pesticides that do not have any food uses. However, the FQPA did not amend any
of the existing reregistration deadlines in section 4 of FIFRA.
EPA is embarking on an intensive process, including consultation with registrants,
States, and other interested stakeholders, to make decisions on the new policies and
procedures that will be appropriate as a result of enactment of FQPA. This process is likely to
include an examination of whether the same or a similar safety standard should apply to non-
food pesticide applications. Such a standard might include exposure of infants and children to
the pesticide(s), cumulative effects on infants and children from this pesticide and other
substances that have a common mechanism of toxicity, and aggregate exposure of the
population and major subgroups of the population to the pesticide and related substances.
The Agency has not yet determined with finality how it will make such decisions. However,
in light of the unaffected statutory deadlines with respect to reregistration, the Agency will
continue its ongoing reregistration program while it continues to determine how best to
implement FQPA.
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In deciding to continue to make reregistration determinations during the early stages of
FQPA implementation, EPA recognizes that it will be necessary to make decisions relating to
FQPA before the implementation process is complete. In making these early, case-by-case
decisions, EPA does not intend to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on a case-by-case basis
and will not bind EPA as it proceeds with further policy development and any rulemaking that
may be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will consider
itself free to pursue whatever action may be appropriate, including but not limited to
reconsideration of any portion of this RED.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of S-Kinoprene. The document consists of six sections. Section I is the
introduction. Section II describes S-Kinoprene, its uses, data requirements and regulatory
history. Section in discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregistration decision for S-Kinoprene.
Section V discusses the reregistration requirements for S-Kinoprene. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name:
Chemical Name:
S-Kinoprene
2-propynyl-(2E,4E)-3,7,ll-trimethyl-2-4-
dodecadienoate
Chemical Family: Trimethyldodecadienoates
CAS Registry Number: 65733-20-2
107502
OPP Chemical Code:
Empirical Formula:
OisHio01
Trade and Other Names: Enstar® II (formerly Enstar® 5E)
Basic Manufacturer:
Sandoz Agro, Inc. (formerly Zoecon Corporation)
1300E. Touhy Ave.
Plaines, IL 60018
B. Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. Details of these uses and application methods of
S-Kinoprene are in Appendix A.
Type of Pesticide: Biochemical pesticide, a synthetic insect growth regulator analog
Use Sites:
Target Pests:
Greenhouse indoor non-food crops: Ornamental plants
(nonflowering, herbaceous, shade trees, woody shrubs and vines)
Aphids, whiteflies, mealybugs, fungus gnats, and armored
scales.
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Formulation Types Registered:
The technical grade active ingredient (TGAI) consists of 89% synthetic
S-Kinoprene and 11% related impurities. The only end-use product, Enstar®!!
(EPA Reg. No. 55947-82) consists of 65.1% TGAI and 34.9% inert
ingredients.
Method and Rates of Application:
Preventative program (before insect populations reach damaging levels):
Enstar®n should be mixed at a rate of 5 ounces per 100 gallons of water per 15,000-
20,000 square feet, and sprayed to runoff every two weeks.
Curative program (for an existing population of adult insects): Two
applications, seven days apart, of Enstar® n to runoff at the rate of 10 ounces per 100
gallons of water per 15,000-20,000 square feet. Two weeks later, the preventive
program should be implemented and the mixture should be sprayed to runoff every
two weeks.
For fungus gnat and root mealybug control: To control larval and adult fungus
gnats, Enstar®n must be applied at 5 ounce per 100 gallons of water; complete
coverage of soil is essential for fungus gnat control.
When infestations of root mealybugs are observed the entire pot containing the
infested plant should be drenched by submersion in a solution of Vz ounce per 5
gallons of water.
Type of Treatment: Soil drench; Spray (indoor use only)
Equipment:
Timing:
Sprayer (conventional, Electro
Static Spraying System®, Puls-fog®)
Interiorscapes; potted; prebloom
Use Practice Limitations: Do not use Enstar®!! through any type of irrigation
system.
C. Estimated Usage of Pesticide
The average annual estimated use is 1,000 pounds of active ingredient applied
to 3,200 acres of ornamental plants in greenhouses and interiorscapes with 70% total
usage in the States of California and Texas.
_
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D. Data Requirements
Data requested in the Data Call-In for S-Kinoprene dated September 30, 1993,
includes studies on toxicology, i.e., a standard battery of genotoxicity tests. These
data were required to support the uses listed in the Data Call-In. All mammalian
toxicology data are available. All product chemistry data are adequately satisfied. In
light of the current indoor use pattern, the Agency will not impose any environmental
fate requirements for reregistration of the currently registered products containing
S-Kinoprene. All the ecological effects data requirements for S-Kinoprene have been
adequately fulfilled. No additional data are required.
E. Regulatory History
Kinoprene was registered in the United States in 1975 under the trade name
Enstar®5E, and renamed Enstar®H, (EPA Reg. No. 55947-82) for use as an
insecticide on indoor non-food/non-feed crops grown in greenhouses and nurseries. A
Data Call-In was issued on September 30, 1993 to Sandoz Agro, Inc., the registrant for
S-Kinoprene, requiring additional toxicity data to satisfy the genotoxicity requirement.
Case No. 4117 also consists of R-S Hydroprene (488300), and R-S Kinoprene
(107501) which are no longer supported by the registrant. S-Hydroprene (128988)
was registered in 1986. This decision includes a comprehensive reassessment of the
required target data and the use patterns of the currently registered product.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public
Law 104-170) was signed into law. EPA is embarking on an intensive process,
including consultation with registrants, States, and other interested stakeholders, to
make decisions on the new policies and procedures that will be appropriate as a result
of enactment of FQPA. This process will include a more in depth analysis of the new
safety standard and how it should be applied to both food and non-food pesticide
applications. However, in light of the unaffected statutory deadlines with respect to
reregistration, the Agency will continue its ongoing reregistration program while it
continues to determine how best to implement FQPA.
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Chemistry Assessment
All product chemistry data requirements for S-Kinoprene technical
grade active ingredient and the end-use product Enstar®E are satisfied. These
data will support a Reregistration Eligibility Decision (RED).
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a. Product Identify and Mode of Action
Table 1.
S-Kinoprene [2-propynyl-(2E, 4E)-3,7,ll-trimethyl-2-4-
dodecadienoate] is a chemically synthesized insect juvenile hormone
• analog. When S-Kinoprene is applied at a low rate, normal insect
growth is inhibited during the molting process causing morphogenic,
ovicidal, and sterilization effects. S-Kinoprene applied at a higher rate,
kills the adult insects.
b. Tolerance Exemption and Food/Non-Food Use
S-Kinoprene is an insecticide used on indoor non-food/non-feed
crops and ornamental plants grown in greenhouses and nurseries.
Therefore, a tolerance establishment/exemption is not an issue for these
current uses.
c. Physical and Chemical Property Assessment
The analytical method used to determine S-Kinoprene is gas-
liquid chromatogram (GLC) utilizing a flame ionization detector (FID).
Structural Formulation:
Empirical Formulation:
Molecular Weight:
CAS Registry No.:
CH3CH(CH3)(CH2)3CH(CH3)CH2CH=CHC
(CH3)=CHCO2CH2CHCH
276
65733-20-2
The generic data requirements for physical and chemical
characteristics of the technical grade active ingredient containing 89%
S-Kinoprene are summarized in Table 1.
Physical and Chemical Properties of S-Kinoprene
Guideline No. 151B-17
Color
Physical state
Odor
Boiling point
Density, specific gravity
Results
Clear amber
Oily liquid
Mild fruity
134°Cat0.1mmHg
0.918 at 25°C
MRIDNo.
41591503
41591503
41591503
41591503
41591503
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Physical and Chemical Properties of S-Kinoprene
Guideline No. 151B-17
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient (Kow)
PH
Stability
Results
Insoluble in water; 0.21 1 ppm at 25°C and
soluble in most organic compounds
7.19xlO-smmHg'at-
20°C
*N/A
2.38X105at25°C
*N/A
Stable
MREDNo.
41898904
Merck Index
Eleventh Edition
41591503
41898904
41591503
41591503
"Not applicable because S-Kinoprene is insoluble in water.
B. Human Health Assessment
All mammalian toxicology data requirements have been submitted and
adequately satisfy the requirements as set forth in 40 CFR 158.690 for biochemical
pesticides for non-food/non-feed use. The mammalian toxicology data base includes
acute toxicity studies, and a battery of genotoxicity studies. Based on the use sites, use
patterns, application method, use rates, low exposure, and lack of significant
toxicological concerns, as demonstrated in the submitted toxicology studies, the
potential risks, if any, to humans are considered negligible.
1. Toxicology Assessment
Adequate mammalian toxicology data are available to support
reregistration of the active ingredient S-Kinoprene.
a. Acute Toxicity
All acute mammalian toxicology studies have been submitted
and adequately satisfy the requirements for non-food/non-feed use. The
following toxicology studies were submitted to support the
reregistration of the active ingredient S-Kinoprene as summarized in
Table 2.
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Table 2.
Guideline No.
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
Study
Acute Oral LD50 (rat)
Acute Dermal LD50 (rat)
Acute Inhalation LD50 (rat)
Primary Eye Irritation (rabbit)
Primary Dermal Irritation (rabbit)
Dermal Sensitization (guinea pigs)
Results
>6.8 g/kg*
>2g/kg
>5.36mg/l**
Slight to moderate irritation ***
Moderate irritation (Draize)
Not a dermal sensitizer
Category
IV
III
IV
III
III
N/A
MRIDNo.
41591509
41591510
41591501
41591507
41591513
47009035
Males and females combined
Greater than 4.78 mg/L when adjusted for purity
A single dose of undiluted test material produced slight to moderate conjunctiva! irritation in three (3) treated eyes at 1 hr post-
treatment which persisted for 48 to 72 hrs. The cornea and iris of all rabbits appeared normal throughout the course of the study.
b. Mutagenicity
Mutagenicity studies have been submitted and adequately satisfy
the requirements as set forth in 40 CFR 158.690. No additional data
and/or information will be required. The following studies were
submitted to support the registration of the active ingredient (Table 3).
Table 3.
Mutagenicity Studies - Ames Assay
Guideline No.
152B-17
Study
Ames Assay*
Unscheduled DNA Synthesis (UDS)
In vivo Mammalian Cytogenetics
Results
Not mutagenic
Did not initiate UDS
Not mutagenic
MRBO No.
41591514
43015201
43015202
The test substance, S-Kinoprene, was not mutagenic, and caused no cytotoxicity or did not increase in mutant colonies of the five
Salmonella typhimurium tester strains at any dose with or without metabolic activation.
C.
Subchronic Assessment
A 90-day feeding study is not required because the non-
food/non-feed uses do not require a tolerance or exemption from
tolerance; and the uses are not likely to result in repeated human
exposure by the oral route. Likewise, the 90-day dermal and inhalation
toxicity studies are not required because the use pattern does not result
in a long-term inhalation exposure at concentrations that are likely to be
toxic, and there is no purposeful application to human skin, nor is
8
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prolonged dermal exposure likely. A developmental toxicity study is
not required because the use pattern of S-Kinoprene is not reasonably
expected to result in significant exposure to pregnant women. The
immunotoxicity study can be waived because of lack of significant
exposure, and because of the lack of significant toxicological effects in
the submitted acute toxicity studies with S-Kinoprene.
d. Exposure Assessment
(1) Non-dietary/Dietary Exposure
The uses of S-Kinoprene do not require a tolerance or an
exemption from tolerance, and dietary exposure from the uses of
S-Kinoprene is unlikely. Acute exposure from the proposed
greenhouse and indoor use sites may occur, but would be very
low because of the low application rates. The average annual
estimate use is 1,000 pounds of active ingredient applied to
3,200 acres of ornamental plants in interiorscapes and
greenhouses with 70% total usage in the States of California and
Texas.
(2) Occupational and Residential
Based on the application methods, the potential for
dermal, eye, and inhalation exposures to S-Kinoprene for
pesticide handlers and applicators exist. Because of the lack of
significant mammalian toxicity, worker exposure data (i.e.,
occupational exposure data) to the active ingredient are not
required at this time. However, due to the primary eye irritation
response (Toxicity Category El) the Agency will require the
appropriate Signal Word (Caution) and Statements of Precaution
(Causes slight eye irritation. Avoid contact with eyes or
clothing. Wash thoroughly with soap and water after handling).
Based on the use sites, use patterns, application method,
and use rates, the potential exposure to humans, including infants
and children, is negligible.
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2.
Human Risk Assessment
a. Non-Dietary/Dietary Risk
The potential risks to humans, including infants and children
from non-dietary routes are considered negligible based on the lack of
significant toxicological concerns low application rates, and minimal
exposure.
Although the potential for dermal, eye, and inhalation exposures
' to the pesticide for pesticide handlers and applicators exist, risk
characterization is unnecessary because of the low dermal and
inhalation toxicity, coupled with low exposure. In addition, there are no
incident reports of adverse effects from exposure.
C. Environmental Assessment
All ecological toxicity and environmental fate data requirements have been
adequately satisfied according to the guidelines set forth in 40 CFR 158.690 for
biochemical pesticides for non-food/non-feed use.
1. Ecological Toxicity Data
In the Phase IV review of S-Kinoprene, the Ecological Effects Branch
(EEB), Environmental Fate and Effects Division (EFED), waived all non-target
data requirements because "Based "on the use patterns, exposure to non-target
organisms is expected to be non-existent or negligible." (March 30, 1993
Memorandum from Anthony F. Maciorowski to Bruce Sidwell). An aquatic
invertebrate toxicity study involving Daphnia (Table 4) recently has been
submitted under FIFRA 6(a)2. All data requirements for S-Kinoprene have
been adequately fulfilled; no additional studies are required for these uses.
Table 4.
Non-target Toxicity Studies - Tier I Guideline Requirements for S-Kinoprene
Guideline No.
154B-9
Study
Invertebrate Toxicity -Daphnia Magna
Results
ECj0 = 102//g/L; highly toxic;
test material = 89.6%
MRID
42756300
2.
Environmental Fate
In the Phase IV review of S-Kinoprene, the Environmental Fate and
Groundwater Branch (EFGWB) in the Environmental Fate and Effects
10
-------
Division, did not require any Environmental Fate data for S-Kinoprene based
on the use-patterns and low application rates (May 15, 1993 Memorandum
from E. Brinson Conerly-Parks to Bruce Sidwell). Currently, Environmental
Fate data are not required for biochemical pesticides unless effects in Tier I
non-target studies indicate fate studies would be needed (40 CFR 185.690).
3. Exposure and Risk Characterization
S-Kinoprene was considered "highly toxic" to DaphniaMagna (Table
4). However, water insoluble material like S-Kinoprene might cause adverse
effects to Daphnia based on the inherent design of the toxicity study (Guideline
154B-9). Since the use of S-Kinoprene is limited to greenhouses and
interiorscapes and such use patterns are not expected to pose a significant risk
to aquatic invertebrates, environmental fate studies will not be required.
Rather, any potential effects will be further mitigated by including label
language "do not contaminate water, food or feed by storage or disposal."
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the generic (technical grade active
ingredient) data required to support reregistration of products containing S-Kinoprene
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 S-Kinoprene. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of
S-Kinoprene, 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 S-Kinoprene and to determine that S-Kinoprene can be used
without resulting in unreasonable adverse effects to humans, including infants and
children, and the environment. The Agency therefore finds that all products
containing S-Kinoprene as the active ingredient are eligible for reregistration for these
(non-food/non-feed) use patterns. 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
11
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acceptable studies to generate such data, published scientific literature, etc. and the
data identified in Appendix B. Although the Agency has found that all uses of
S-Kinoprene 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 S-Kinoprene, 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 technical grade active
ingredient S-Kinoprene, the Agency has sufficient information on the health
effects of S-Kinoprene and on its potential for causing adverse effects in fish
and wildlife and the environment. The Agency has determined that
S-Kinoprene products, labeled and used as specified in this document will not
pose unreasonable risks or adverse effects to humans, including infants and
children, or the environment. Therefore, the Agency concludes that products
containing S-Kinoprene for all non-food/non-feed uses are eligible for
reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that certain uses of S-Kinoprene are
eligible for reregistration.
Greenhouse Non-food Crop; Ornamental plants (non-flowering, herbaceous,
shade trees, woody shrubs and vines)
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
S-Kinoprene. Where labeling revisions are imposed, specific language is set
forth in Section V of this document.
1.
Tolerance Reassessment
S-Kinoprene is used on indoor non-food/non-feed crops and ornamental
plants grown in greenhouses and interiorscapes. Therefore, a food tolerance
establishment/exemption is not required for these current uses.
12
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2. Endangered Species Statement
The Agency has no concerns about the exposure of threatened and
endangered species to S-Kinoprene since it is used on non-food/non-feed
indoor greenhouses and nurseries.
3. Labeling Rationale
a. Worker Protection Standard
Any product whose labeling reasonably permits use in the
production of an agricultural plant on any farm, forest, interiorscapes, or
greenhouse must comply with the labeling requirements of PR Notice
93-7, "Labeling Revisions Required by the Worker Protection Standard
(WPS), and PR Notice 93-11, "Supplemental Guidance for PR Notice
93-7, which reflect the requirements of EPA1 s labeling regulations for
worker protection statements (40 CFR part 156, subpartK). 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.
The labels and labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR § 156.10
and other applicable notices.
13
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b. Precautionary Labeling
The Agency has examined the toxicological data base for
S-Kinoprene and concluded that the current precautionary labeling (i.e.
Signal Word, WARNING) needs to be amended to read "CAUTION"
insofar as the toxicological data falls within category in and IV.
c. Application Rate
It is the Agency's position, that the labeling for the pesticide
products containing S-Kinoprene complies with the current pesticide
labeling requirements.
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 S-Kinoprene for
the above eligible uses has been reviewed and determined to be substantially
complete.
2. Labeling Requirements for Manufacturing-Use Products
Not Applicable; there are currently no manufacturing use products
registered. However, in the event that a registrant wishes to register a MP in
the future, to be in compliance with FIFRA, manufacturing use product
labeling must comply with all current EPA regulations, PR Notices, and
applicable policies.
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 data base supporting the reregistration of Enstar®!!,
containing S-Kinoprene is substantially complete and no additional product
specific data is being required at this time.
14
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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 Notice 93-7,
which reflect the requirements of EPA1 s labeling regulations for worker
protection statements (40 CFR part 156, subpartK). 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.
Restricted-Entry Interval TREK; The Agency has determined that the
interim REI of 12 hours, may in certain circumstances, be reduced to 4 hours
for pesticides with low acute mammalian toxicities (i.e. products with acute
mammalian toxicities in Categories HI and IV), such as the case of
S-Kinoprene. However, the current REI for Epcot Center is labeled for 12
hours.
Maximum Application Rate: The labels and labeling of all products must
comply with EPA's current regulations and requirements as specified in 40
CFR & 156.10 and described in the Pesticide Reregistration Handbook.
Storage and Disposal: Current labeling is acceptable insofar as non-food use
pattern. Current label reads, do not contaminate water, food or feed by storage
or disposal.
Updated Labeling and Other Requirements: Registrants must specify on
labeling the complete directions for use for each use pattern: site of
application, type of application, timing of application, equipment used for
application, the rate of application (dosage), and maximum application rate.
Insofar as use pattern, current labeling is acceptable.
The registrant must submit five (5) copies of the updated labeling and
the updated Confidential Statement of Formula for each registered product.
15
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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
S-Kinoprene 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.
16
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VI. APPENDICES
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
active ingredients within the case S-Kinoprene covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to S-Kinoprene in all
products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1 - Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the
test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3 • Bibliographic citation /Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
23
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions.. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number." This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
27
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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 position of the study
within the volume.
28
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BIBLIOGRAPHY
MRID
CITATION
41591501 Sandoz Crop Protection Corp. (1990) Product Identity and Disclosure of
Ingredients: ENSTARII Insect Growth Regulator: Lab Project Number: 8790.
Unpublished study. 7 p.
41591503 Sandoz Crop Protection Corp. (1989) Physical and Chemical Properties of
S-Kinoprene Technical and S-ENSTAR: Lab Project Number: 432043.
Unpublished study. 160 p.
41591504 Kynoch, S.; Denton, S.; Healing, G. (1989) Acute Oral Toxicity to Rats of
S-ENSTAR 5E: Lab Project Number: 9081D/SNC 78/AC. Unpublished study
prepared by Huntingdon Research Ctr. 26 p.
41591507 Liggett, M. (1989) Irritant Effects on the Rabbit Eye of S-ENSTAR 5 E: Lab
Project Number: 9051D/SNC81/SE. Unpublished study prepared by
Huntingdon Research Ctr. 12 p.
41591509 Kynoch, S.; Denton, S.; Healing, G. (1990) Acute Oral Toxicity to Rats of
S-Kinoprene Technical (SAN 847): Lab Project Number: 901 29D/SNC
78/AC. Unpublished study prepared by Huntingdon Research Ctr. 25 p.
41591510 Kynoch, S.; Denton, S.; Healing, G. (1989) Acute Dermal Toxicity to Rats of
S-Kinoprene Technical (SAN 847): Lab Project Number: 891497D/SNC
79/AC. Unpublished study prepared by Huntingdon Research Ctr. 18 p.
41591513 Liggett, M. (1989) Irritant Effects on Rabbit Skin of S-Kinoprene Technical
(SAN 847): Lab Project Number: 9048D/SNC 80/SE. Unpublished study
prepared by Huntingdon Research Ctr. 9 p.
41898901 Sandoz Crop Protection Corp. (1991) S-Kinoprene Technical Active Ingredient
Product Identity and Disclosure of Ingredients: Lab Project Number: 52291.
Unpublished study. 15 p.
41898902 Baer, T. (1991) Manufacturing Process Description and Discussion of the
Formation of Unintentional Ingredients for S-Kinoprene/Enstar II: Lab Project
Number: 591 A. Unpublished study prepared by Sandoz Crop Protection Corp.
HOp.
41898903 Sandoz Crop Protection Corp. (1991) Purity Determination of ZR-777
(Kinoprene): Lab Project Number: 51491. Unpublished study. 13 p.
41898904 Yu, C. (1991) S-Kinoprene: Determination of n-Octanol/Water Partition
Coefficient: Lab Project Number: 440065: RPT. NO. 3: RPT. NO. 1.
Unpublished study prepared by Sandoz Crop Protection Corp. 38 p.
29
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BIBLIOGRAPHY
MRID
CITATION
42756300 Sandoz Agro, Inc. (1993) Submission of Toxicity Data in Support of FIFRA
6(a)(2) Requirements for S-Kinoprene. Transmittal of 1 Study.
43015201 McKeon, M. (1990) Mutagenicity Test on S-Kinoprene Technical in the in
vitro Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: Final
Report: Lab Project Number: 12227/0/447. Unpublished study prepared by
Hazleton Labs America, Inc. 23 p.
43015202 Ivett, J. (1990) Mutagenicity Test on S-Kinoprene Technical in vivo Mouse
Micronucleus Assay: Final Report: Lab Project Number: 12227/0/455.
Unpublished study prepared by Hazleton Labs America, Inc. 24 p.
30
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The following is a list of available documents for S-Kinoprene that my further assist
you in responding to this Reregistration Eligibility Decision document. These documents
may be obtained by the following methods:
Electronic
File format:
1.
Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Beverly Sjoblad at (703)-308-8376.
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 S-Kinoprene.
The following documents are part of the Administrative Record for S-Kinoprene and
may included iri the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may
be obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
31
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