United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-94-025
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
(Z)-9-Tricosene
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 years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 4112, (Z)-9-tricosene.
(Z)-9-tricosene is the sex-attractant pheromone of the female housefly.
This biochemical pesticide is used in a number of places where fly control is
necessary including food/feed handling establishments, livestock premises
and residential areas. However, these are considered non-food/feed uses
because label restrictions prohibit use near food and feed. (Z)-9-tricosene is
formulated as an impregnated material or pest strip, as well as a granular
and crystal. Products are applied by hand, using rubber gloves or a cup or
scoop.
Use restrictions for products containing (Z)-9-tricosene include: use
granules and crystals in bait stations or only in places inaccessible to birds;
strips containing the chemical may not be placed in areas where birds, pets
or children can accidentally come in contact; products are not permitted in
food areas of food handling establishments, or where milk is processed or
stored; and products must be kept out of reach of food producing animals.
-------
Regulatory Pesticide products containing (Z)-9-tricosene were first registered in
History the United States in 1975. Currently, there are twelve products registered,
several also containing other pesticide active ingredients.
Human Health
Assessment
Physical Chemistry
(Z)-9-tricosene is classified as a biochemical pesticide because even
though it is chemically synthesized, it is identical to the sex pheromone of
the female house fly Musca domestica.
There are certain technical chemistry issues to be resolved, including
the method used to quantify the percent active ingredient. This leads to a
deficiency in the Certification of Ingredient Limits and also the validation of
the method used to verify certified limits. These deficiencies are considered
minor to the Agency's ability to assess the risks associated with the current
uses of (Z)-9-tricosene products. However, the Agency is requiring
confirmatory data to correct these deficiencies and accurately characterize
the technical chemistry of the (Z)-9-tricosene.
Toxicity
Other than slight eye and dermal irritation effects, and possibly
moderate dermal sensitization, (Z)-9-tricosene showed no significant signs
of acute toxicity. Because of its use patterns, no further toxicology studies
are required.
Dietary Exposure
There are no established tolerances or tolerance exemptions for (Z)-9-
tricosene. All labels bearing directions for use in food or feed handling
establishments must carry restrictions to keep products containing this
chemical away from food and feed areas and out of reach of livestock.
These uses are classified as non-food uses and thus, there are no dietary
exposure concerns.
Occupational and Residential Exposure
Based on the registered uses of products containing (Z)-9-tricosene,
there are no worker or residential exposure concerns.
Human Risk Assessment
The potential risks to humans from both non-dietary and dietary routes
are considered negligible. Because the active ingredients are impregnated or
embedded in a solid polymeric matrix shell, there is low potential for
exposure and there are no toxicological concerns.
-------
Environmental
Assessment
Environmental Fate
The major routes of dissipation in the environment for (Z)-9-tricosene
are volatilization and microbial mediated degradation.
Ecological Effects
(Z)-9-tricosene has low toxicity to mammalian species that may come
in contact with this pesticide in the environment. The chemical is
practically non-toxic to birds or freshwater fish on an acute oral basis. On a
subacute dietary basis, it is practically non-toxic to upland game birds and
waterfowl.
(Z)-9-tricosene is very highly toxic, even in low doses, to waterfowl
for reproductive effects and is also highly toxic to freshwater invertebrates.
Additional Data
Required
Product Labeling
Changes Required
Ecological Effects Risk Assessment
For products which contain impregnated materials and solid matrix
forms (bait stations and strips), it is assumed that exposure to terrestrial and
aquatic species will be minimal. For products formulated as crystals or
granules, minimal acute effects to terrestrial species can be expected.
Effects to aquatic invertebrates may occur if direct application of the
chemical accidentally occurs.
Endangered Species
Based on the current use pattern for products formulated as crystals
and granules, the potential risk of adverse acute effects to avian, aquatic and
mammalian endangered species would be minimal. However, there could
be a risk of reproductive effects to endangered avian species.
EPA is requiring confirmatory generic product chemistry data on the
method used to quantify the percent of the active ingredient. Product-
specific data including product chemistry, revised Confidential Statements of
Formula (CSFs) and revised product labeling also are required for
reregistration of products containing (Z)-9-tricosene.
The labels of all registered end use products containing (Z)-9-tricosene
must comply with EPA's current labeling requirements, and with the
following:
Avian Risk Mitigation: To mitigate the avian reproduction toxicity
concern for broadcast products and the accessibility to birds, the Agency is
requiring registrants to modify their products in a manner that would
significantly reduce the exposure potential to birds, such as bait stations.
-------
Regulatory
Conclusion
For More
Information
The use of registered products containing (Z)-9-tricosene will not pose
unreasonable risks or adverse effects to humans or the environment,
provided that these products are used in accordance with the restrictions on
product labeling. Therefore, all uses of these products are eligible for
reregistration. Products containing (Z)-9-tricosene will be reregistered once
required confirmatory generic data, product-specific data, Confidential
Statements of Formula and revised labeling are received and accepted by
EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for (Z)-9-tricosene 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.
Following the comment period, the (Z)-9-tricosene RED document
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 (Z)-9-tricosene RED, or reregistration of individual products containing
(Z)-9-tricosene, 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 8:00 am and 6:00 pm Central Time, Monday
through Friday.
------- |