United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-030
November 1996
R.E.D. FACTS
Pesticide
Reregistration
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 reregi strati on, 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 reregi strati on, 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
reregi strati on case 4117, S-Kinoprene.
Use Profile
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-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®!! (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®!!, (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.
Toxicity
Adequate mammalian toxicology data are available to support
reregi strati on of the active ingredient S-Kinoprene, and will support a
Reregi strati on 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 amend any of the existing
reregi strati on 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 reregi strati on, the
Agency will continue its ongoing reregi strati on program while it continues
to determine how best to implement FQPA.
In deciding to continue to make reregi strati on 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 III) 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
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
Groundwater 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
CFR185.690).
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 reregi strati on of S-Kinoprene 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.
Product Labeling
Changes
Required
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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The registrant must submit five (5) copies of the updated labeling and
the updated Confidential Statement of Formula for each registered product.
Regulatory
Conclusion
For More
Information
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 Reregi strati on
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 reregi strati on.
EPA is requesting public comments on the Reregi strati on 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 Reregi strati on 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 reregi strati on program,
the S-Kinoprene RED, or reregi strati on of individual products containing
S-Kinoprene, please contact the Special Review and Reregi strati on 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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