US Environmental Protection Agency
Office of Pesticide Programs
BIOPESTICIDES REGISTRATION ACTION DOCUMENT
(Z)-ll-Hexadecenyl Acetate Technical Pheromone (PC Code 129071) ~
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
BIOPESTICIDE REGISTRATION ACTION DOCUMENT
(Z)-ll-Hexadecenyl Acetate Technical Pheromone
(PC Code 129071)
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
(Z)-l 1-Hexadecenyl Acetate
(PC Code 129071)
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
Table of Contents
I. Executive Summary
A. IDENTITY
B. USE/USAGE
C. RISK ASSESSMENT
D. DATA GAPS / LABELING RESTRICTIONS
II. Overview
A. ACTIVE INGREDIENT OVERVIEW
B. USE PROFILE
C. ESTIMATED USAGE
D. DATA REQUIREMENTS
E. REGULATORY HISTORY
F. CLASSIFICATION
G. FOOD CLEARANCES/TOLERANCES
III. Science Assessment
A. PHYSICAL/CHEMICAL PROPERTIES ASSESSMENT
1. Product Identity and Mode of Action
2. Food Clearances/Tolerances
3. Physical and Chemical Properties Assessment
B. HUMAN HEALTH ASSESSMENT
1. Toxicology Assessment
2. Dose Response Assessment
3. Dietary Exposure and Risk Characterization
4. Occupational, Residential, School and Day Care Exposure and Risk
Characterization
a. Occupational Exposure and Risk Characterization
b. Residential, School and Day Care Exposure and Risk Characterization
5. Drinking Water Exposure and Risk Characterization
6. Acute and Chronic Dietary Risks for Sensitive Subpopulations
Particularly Infants and Children
7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation
C. ENVIRONMENTAL ASSESSMENT
1. Ecological Effects Hazard Assessment
2. Environmental Fate and Ground Water Data
3. Ecological Exposure and Risk Characterization
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
D. EFFICACY DATA
IV. Risk Management Decision
A. DETERMINATION OF ELIGIBILITY FOR REGISTRATION
B. REGULATORY POSITION
1. Conditional/Unconditional Registration
2. Tolerance Reassessment
3. CODEX Harmonization
4. Nonfood Re/Registrations
5. Risk Mitigation
6. Endangered Species Statement
C. LABELING RATIONALE
1. Human Health Hazard
a. Worker Protection Standard
b. Non-Worker Protection Standard
c. Precautionary Labeling
d. Spray Drift Advisory
2. Environmental Hazards Labeling
End-Use Product Environmental Hazards Labeling
3. Application Rate
D. LABELING
V. Actions Required by Registrants
VI. Appendix A
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
I. EXECUTIVE SUMMARY
A. IDENTITY
The new active ingredient (Z)-l 1-hexadecenyl acetate is a technical grade synthetic pheromone, to be
used in the manufacturing of end-use pheromone products. The Technical Grade Active Ingredient
(TGAI) contains 95 % of Z-l 1-hexadecenyl acetate. The product chemistry data submitted by the
registrant satisfies the requirement for product identity.
B. USE/USAGE
The TGAI will be used for incorporation into end-use products intended for agricultural application
for the control of the Diamondback Moth and other insect pests.
C. RISK ASSESSMENT
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone is a lepidopteran pheromone.
Toxicology and environmental data requirements for this pheromone product were waived or deemed
not necessary for registration per the Agency publication entitled "Generic Fact Sheet for
Lepidopteran Pheromones (12/99)." This document reports that no risks to human health are
expected from the use of lepidopteran pheromones based on the low toxicity in animal testing, and
expected low exposure to humans. Further, adverse effects on nontarget organisms are not expected
because these pheromones are released in very small quantities in the environment and act on a select
group of insects. However, appropriate precautionary labeling of end use products will minimize
exposure and mitigate risk to nontarget organisms.
Therefore, the Agency is making the risk management decision regarding the registration of the Z-
11-Hexadecenyl Acetate Technical Pheromone product based on the following criteria: 1) known low
toxicity of lepidopteran pheromones, 2) the low application rate for end-use products; and 3)
precautionary labeling which minimizes exposure and mitigates risks and further concludes that Z-
11-hexadecenyl acetate pheromone products can be used without causing unreasonable adverse
effects to humans or the environment.
Based on the negligible risk concerns and a history of safe use of lepidopteran pheromones in
general, (Z)-l 1-Hexadecenyl Acetate Technical Pheromone meet the criteria as specified in
§3(c)(5) of FIFRA as amended, and are thus eligible for unconditional registration. No additional
data are needed.
This document presents the Agency's decision regarding the registration of new active ingredient
(Z)-l 1-hexadecenyl acetate.
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
D. DATA GAPS / LABELING RESTRICTIONS
There are no data gaps.
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
I. OVERVIEW
A. ACTIVE INGREDIENT OVERVIEW
Common Name:
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
Chemical Name:
(Z)-ll-hexadecenyl acetate
Chemical Formula:
C, TLX)
18 34^2
Chemical Family:
Lepidopteran Pheromones
Trade and Other Names: Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
CAS Registry Number: 34010-21-4
B. USE PROFILE
The following is information on the proposed uses with an overview of use sites and application
methods.
Type of Pesticide: Lepidopteran Pheromone (insect attractant; mating disrupter)
Use Sites: Manufacturing use only. This product is for formulation into pheromone end-use
products for use to control insects in/on agricultural commodities.
Target: Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone, in combination with
other pheromones, will be used for the control of Diamondback Moth and other insects.
Formulation Types: Liquid.
Method and Rates of Application: Manufacturing use only. The TGAI will be used for
incorporation into end-use products intended for agricultural application for the control of
Diamondback Moth and other insect pests.
Use Practice Limitations: "For Manufacturing Use Only"
"For Use in Manufacturing or Formulating Registered Pesticide Products"
OPP Chemical Code:
129071
Basic Manufacturer: Bedoukian Research, Inc.
21 Finance Dr.
Danbury, CT 06810
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
C. ESTIMATED USAGE
None used yet since this will be the first registered product.
D. DATA REQUIREMENTS
The Agency has supported the request for waivers from the requirements of studies/data for acute
mammalian toxicity and nontarget organisms. These data were waived based on the following criteria
from the Agency publication entitled "Generic Fact Sheet for Lepidopteran Pheromones (12/99)": 1) low
toxicity in animal testing, 2) expected low exposure to humans, 3) no risk to human health is expected;
and 4) adverse effects to nontarget organisms are not expected because these pheromones are released
in very small quantities in the environment and act on a select group of insects. Product analysis data
requirements were adequately satisfied.
The data requirements for granting this registration under Section 3(c)(5) of FIFRA have been reviewed
by the Biopesticides and Pollution Prevention Division (BPPD). Based on the submitted information,
the Agency foresees no unreasonable adverse effects to human health and the environment from the use
of this pheromone, and recommends an unconditional registration.
E. REGULATORY HISTORY
On June 20, 2000, the Agency received an application from Bedoukian Research, Inc. to register
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone, containing 95.0 % of (Z)-l 1-hexadecenyl
acetate as a active ingredient. A notice of receipt of the application for registration of (Z)-ll-
hexadecenyl acetate as a new active ingredient was published in the Federal Register on December 13,
2000 (65 FR 77874) with a 30-day comment period. No comments were received as a result of this
publication.
F. CLASSIFICATION
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone is a synthetic compound that mimics
naturally occurring substances of insect origin and functions by a non-toxic mode of action on its target
pest, therefore, this compound is classified as a biochemical pesticide.
G. FOOD CLEARANCES/TOLERANCES
Lepidopteran pheromones are exempt from the requirement of a tolerance in or on raw agricultural
commodities. This exemption pertains to only those situations when the pheromone is applied to
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
growing crops at a rate not to exceed 150 grams active ingredient per acre per year in accordance with
good agricultural practices (40 CFR §180.1153).
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
II SCIENCE ASSESSMENT
A. PHYSICAL/CHEMICAL PROPERTIES ASSESSMENT
All product chemistry data requirements for Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical
Pheromone are satisfied.
1. Product Identity and Mode of Action
a. Product Identity:
The new active ingredient, (Z)-l 1-hexadecenyl acetate, is a technical grade synthetic pheromone. The
TGAI is clear liquid with a mild fatty odor. The product chemistry data submitted by the registrant
satisfies the requirement for product identity.
b. Mode of Action:
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone, in combination with other pheromones,
will be used for the control of Diamondback Moth and other insects.
Per the Generic Fact Sheet for Lepidopteran Pheromones (dated \2!99\. "All of the lepidopteran
pheromones that EPA has approved for pesticide use are chemicals produced by female moths to attract
a mate. The pesticide products contain synthetic versions of these naturally occurring compounds
Sometimes the relative amounts of several pheromone chemicals in a pesticide product determine which
specific pests are controlled.
When the pesticide product releases the pheromone into the air where males are looking for females, the
males become confused and cannot easily locate the females. As a result, many of the females do not
mate and lay eggs, and there are many fewer offspring than usual."
2. Food Clearances/Tolerances
Currently, a tolerance exemption exists for lepidopteran pheromones such as Bedoukian (Z)-ll-
Hexadecenyl Acetate Technical Pheromone used at a rate not to exceed 150 grams active ingredient per
acre per year in accordance with good agricultural practices (40 CFR 180.1153).
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
3. Physical And Chemical Properties Assessment
The physical and chemical characteristics of the TGAI were submitted to support the registration. These
are summarized in Table 1.
Table 1. Product chemistry data requirements
GUIDELINE
NO.
STUDY
RESULTS
MRID NO.
151-10 (OPPTS
880.110)
151-11
(OPPTS
880.1200)
Product identity;
Manufacturing
process;
Submitted data satisfies the data
requirements for product identity,
manufacturing process, and
discussion of formation of impurities
451518-01
453285-01
151-12
(OPPTS
880.1400)
Discussion of
formulation of
unintentional
ingredients
151-13
(OPPTS
880.1500)
Analysis of samples
Submitted data satisfy the data
requirements for analysis of samples
451518-01
151-15
(OPPTS
880.1600)
Certification of limits
Limits listed in the CSF are adequate
451518-01
453285-01
151-16
(OPPTS
880.1700)
Analytical method
Acceptable
451518-01
453285-01
PHYSICAL / CHEMICAL PROPERTIES FOR the MP
63-2
(OPPTS
830.6302)
Color
Colorless to pale yellow
451518-01
63-3
(OPPTS
830.6302)
Physical State
Clear liquid
451518-01
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
GUIDELINE
NO.
STUDY
RESULTS
MRID NO.
63-4
(OPPTS
830.6304)
Odor
Mild, fatty
451518-01
63-5
(OPPTS
830.7200)
Melting point
NA (product is a liquid)
63-6
(OPPTS
830.7220
Boiling point
Approx. 145°C at 0.2 mm Hg
451518-01
63-7
(OPPTS
830.7300)
Density/Specific
gravity
Approx. 0.87 gm/mL
451518-01
63-8
(OPPTS
830.7840)
Solubility
2.2 x 10"8 mol/L (estimated) at 25°C
in water
451518-01
63-9
(OPPTS
830.7950)
Vapor Pressure
3.85 x 10"5 mm Hg at 25°C
451518-01
63-12
(OPPTS
830.7000)
pH
NA
63-13
(OPPTS
830.6313)
Stability
study has been submitted, awaiting
MRID number
63.15
(OPPTS
830.6315)
Flammability
Flash point >230°C
451518-01
63.17
(OPPTS
830.6317)
Storage stability
Expected to be stable under normal
storage conditions for a minimum of
1 year
451518-01
63-18
(OPPTS
830.7100)
Viscosity
NA
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Z-l
GUIDELINE
-Hcxaqcpjnvl Ace
tate TccluiTcyPl^icromonc
B iopcsticidc^cgVsVraUo n Action Doc
MRID NO.
.1111C lit
63-19
(OPPTS
830.6319)
Miscibility
NA
63-20
(OPPTS
830.6320)
Corrosion
characteristics
Not Corrosive
451518-01
63-11
(OPPTS
830.7550)
Octanol/water
partition coef.
Kow = 3.7x 10"5 (estimated)
451518-01
B. HUMAN HEALTH ASSESSMENT
1. Toxicology Assessment
The active ingredient, (Z)-l 1-hexadecenyl acetate, is a lepidopteran pheromone. The data available to
the Agency (Federal Register Notice 1/26/94) on lepidopteran and other arthropod pheromones, including
several aromatic pheromones, have indicated no acute mammalian toxicity at the limit dose levels for the
following studies: acute oral toxicity (LD50>5,000 mg/kg - category IV, nontoxic); acute dermal toxicity
(LD50 >2,000 mg/kg - category III, nontoxic); acute inhalation toxicity (LD50 generally > 5 mg/L -
category III-IV, practically nontoxic), no evidence of mutagenicity (Ames Salmonella assay), minimal
eye and skin irritation (category IV), pheromones are also not likely to be dermal sensitizers (Beuhler
hypersensitivity test). Since the lack of toxicity of lepidopteran pheromones is well established, the
Agency has agreed to waive toxicity data requirements for (Z)-l 1-hexadecenyl acetate.
Mammalian toxicity data for (Z)-l 1-hexadecenyl acetate are summarized in Table 2.
Table 2. Mammalian toxicity data requirements
Guideline No.
STUDY
RESULTS
MRID NO.
81-1
(OPPTS
870.1100)
Acute oral toxicity
Waived*
NA
81-2
(OPPTS
870.1200)
Acute dermal toxicity
Waived*
NA
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
81-3
(OPPTS
870.1300)
Acute inhalation toxicity
Waived*
NA
81-4
(OPPTS
870.2400)
Primary eye irritation
Waived*
NA
81-5
(OPPTS
870.2500)
Primary dermal irritation
Waived*
NA
81-6
(OPPTS
870.2600)
Dermal sensitization
Waived*
NA
152-16
(no OPPTS
guidline number)
Hypersensitivity incidents
Incident data
must be reported
*per Agency rationale on Lepidopteran pheromones, see Lepidopteran Pheromone Fact Sheet
The Agency has supported the request for waivers from the requirements of studies/data for acute
mammalian toxicity and nontarget organisms. These data were waived based on the following criteria
from the Agency publication entitled "Generic Fact Sheet for Lepidopteran Pheromones (12/99).": 1) low
toxicity in animal testing, 2) expected low exposure to humans, 3) no risk to human health is expected;
and 4) adverse effects to nontarget organisms are not expected because these pheromones are released
in very small quantities in the environment and act on a select group of insects. Product analysis data
requirements were adequately satisfied.
2. Dose Response Assessment
Based on available information and data from the open scientific literature and the Agency FR Notice
(1/26/94) regarding experimental use permits, no toxicity endpoints were identified.
3. Dietary Exposure and Risk Characterization
Data waivers were requested by the registrant for toxicology and environmental data requirements for
this active ingredient. These data waivers were granted per the Agency publication entitled "Generic
Fact Sheet for Lepidopteran Pheromones (12/99)." This document reports that no risks to human health
are expected from the use of lepidopteran pheromones based on the low toxicity in animal testing and
expected low exposure to humans. Further, adverse effects on nontarget organisms are not expected
because these pheromones are released in very small quantities in the environment and act on a select
group of insects. Additionally, the "Generic Fact Sheet for Lepidopteran Pheromones (12/99)" states
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
that; "the safety record for lepidopteran pheromones has allowed the Agency to conclude that
consumption of food containing residues of the pheromones present no risk."
4. Occupational and Residential Exposure
a. Occupational Exposure and Risk Characterization
The end-use product will be applied via microencapsulated beads or dispensers, therefore, the potential
for dermal, eye, and inhalation exposures to the pesticide exists for both the pesticide handler and
applicator. The Agency will require appropriate signal word and precautionary statements to mitigate
any risk from exposure via dermal, eye, or inhalation routes. However, due to the lack of mammalian
toxicity, worker exposure data on (Z)-l 1-hexadecenyl acetate are not required. The Agency will require
appropriate signal word and precautionary statements to mitigate any risk from exposure via these
routes.
b. Residential, School and Daycare Exposure and Risk Characterization
No indoor residential, school or daycare uses currently appear on the label. Although accidental
nondietary exposure to sites where children are present may occur, the health risk is expected to be
minimal based on low mammalian toxicity, insignificant exposure due to high volatility of the compound,
and a history of safe use.
5. Drinking Water Exposure and Risk Characterization
No significant exposure is expected from an accumulation of (Z)-l 1-hexadecenyl acetate in the aquatic
environment when used according to the precautionary label language.
6. Acute and Dietary Risks for Sensitive Subpopulations, Particularly Infants
and Children
The Agency has concluded that the potential for pheromone residues is not a dietary hazard to the general
population, including infants and children. This decision was based on the following criteria: 1) low
acute and subchronic mammalian toxicity, 2) the known metabolism; and 3) the history of safe use of
similar lepidopteran pheromones. Also, for food uses of pheromones, the toxicity and residue data have
allowed for the conclusion that an exemption from the requirement of a tolerance is appropriate and
adequate to protect human health, including that of infants and children (40 CFR 181.1153).
7. Aggregate Exposure from Multiple Routes Including Dermal, Oral and Inhalation
(Z)-l 1-hexadecenyl acetate is a synthetic compound which mimics naturally occurring pheromones of
insect origin with a non-toxic mode of action to target pests. Low oral, dermal, and inhalation toxicity
has been demonstrated by the data summarized above. Based on this information, BPPD has concluded
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
that aggregate exposure to such lepidopteran pheromones over a lifetime will not pose appreciable risks
to human health. Moreover, the toxicity and exposure data are sufficiently complete to adequately
address the potential for additional sensitivity of infants and children to residues of (Z)-l 1-hexadecenyl
acetate. The Agency concludes that there is reasonable certainty of no harm to infants and children from
aggregate exposure to residues of (Z)-l 1-hexadecenyl acetate.
C. ENVIRONMENTAL ASSESSMENT
1. Ecological Effects Hazard Assessment
The Agency has reviewed and evaluated ecotoxicity data for a number of chemically similar lepidopteran
pheromones, therefore no ecological data are required for (Z)-l 1-hexadecenyl acetate. The Agency
published the following ecotoxicity findings for tests on pheromones in the Federal Register (59 FR
3681; January 26, 1994 ): high toxicity to aquatic invertebrates and moderate toxicity to fish, but
practically no toxicity to birds tested. Data for one lepidopteran pheromone indicated low toxicity to
bobwhite quail, with an acute oral LD50 of >2,000 mg/kg of body weight and dietary LC50 of >5,000
mg/kg. However, this pheromone showed high toxicity to a nontarget, freshwater aquatic invertebrate
{Daphnia magna) with a LC50 of between the solubility limit of 0.2 mg/1 and a calculated LC50 of 0.58
mg/1. Another lepidopteran pheromone was found to be moderately toxic to both Daphnia magna (LC50
= 8.6 mg/1) and the freshwater rainbow trout (LC50= 5.9 mg/1). These results demonstrated the potential
toxicity of lepidopteran pheromones to aquatic organisms.
The Biochemical Pesticides Branch supports the request for data waivers from the requirements of
studies/data for nontarget organisms. These data were waived based on the following criteria from the
Agency publication entitled "Generic Fact Sheet for Lepidopteran Pheromones (12/99).": 1) low toxicity
in animal testing, 2) expected low exposure to humans, 3) no risk to human health is expected; and 4)
adverse effects to nontarget organisms are not expected because these pheromones are released in very
small quantities in the environment and act on a select group of insects.
2. Environmental Fate and Ground Water Data
Exposure assessments on this type of product (biochemical pesticide) are not performed unless significant
human health or ecological effects issues arise in the Tier I studies for either of these disciplines (40 CFR
§ 158.690 (c) and (d)). Since Tier II studies were not triggered, there is no requirement for environmental
fate data.
3. Ecological Exposure and Risk Characterization
The Biochemical Pesticides Branch supports the request for waivers from the requirements of
studies/data for nontarget organisms. Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
is a lepidopteran pheromone. The rationale for supporting the waiver is found in Agency publication
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
entitled "Generic Fact Sheet for LepidopteranPheromones (12/99). This document indicates that adverse
effects to nontarget organisms are not expected because these pheromones are released in very small
quantities in the environment and act on a select group of insects. As a result, no toxicology or
environmental fate and effects data were deemed necessary for registration.
Mitigating label language will further reduce the risk to aquatic organisms. The precautionary labeling
of end-use products stipulates, "Keep out of lakes, ponds, and streams. Do not contaminate water by
disposal of wastes", for the dispensers, and "Do not apply directly to water, or to areas where surface
water is present, or to intertidal areas below the mean high water mark. Do not contaminate water by
cleaning of equipment or disposal of wastes" for the sprayable bead formulations.
Table 3. Non-Target Toxicity studies - Tier I Guideline Requirements for (Z)-l 1-hexadecenyl
acetate
Guideline No.
Study
Result
mrii)
71-1
(OPPTS
850.2100)
Avian acute oral
Waived*
NA
71-2
(OPPTS
850.2200)
Avian dietary
Waived*
NA
72-1
(OPPTS
850.1075)
Freshwater fish LC50
Waived*
NA
154-9
(OPPTS
880.4250)
Freshwater invertebrate LC50
Waived*
NA
*per Agency rationale on Lepidopteran pheromones, see Lepidopteran Pheromone Fact Sheet
D. EFFICACY DATA
No efficacy data were required to be submitted to the Agency, since no public health uses are involved.
IV. RISK MANAGEMENT DECISION
A. DETERMINATION OF ELIGIBILITY
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that
(A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials
required to be submitted comply with the requirements of FIFRA; (C) it will perform its intended
function without unreasonable adverse effects on the environment; and (D) when used in accordance
with widespread and commonly recognized practice, it will not generally cause unreasonable adverse
effects on the environment.
To satisfy criteria "A" above, (Z)-l 1-hexadecenyl acetate is similar in composition to other registered
lepidopteran pheromone products. Pheromones are suitable alternatives to other more toxic lepidopteran
pest control products. Criteria "B" is satisfied by the current label and by the data presented in this
document. It is believed that the (Z)-l 1-hexadecenyl acetate will not cause any unreasonable adverse
effects, is an effective biochemical insecticide for lepidopterous pests, and does provide protection as
claimed satisfying criteria "C". Criteria "D" is satisfied in that the toxicological properties of this
product are less toxic than any other product currently in use, and the products are similar to other
presently registered lepidopterous pheromone products. Therefore, (Z)-11 -hexadecenyl acetate technical
pheromone is eligible for registration. The technical compound will be formulated into pheromone end-
use products, for use to control pests in/on agricultural commodities.
B. REGULATORY POSITION
1. Conditional/Unconditional Registration
Based on the data submitted, BPPD recommends that (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
is eligible for registration under Section 3(c)(5) of FIFRA. BPPD foresees no adverse effects to human
health or the environment from the use of the pheromone at rates not to exceed 150 grams a. i./acre/year.
2. Tolerance Reassessment
The existing tolerance exemption for lepidopteran pheromones (40 CFR 180.1153) is applicable to (Z)-
11-Hexadecenyl Acetate Technical Pheromone.
3. Codex Harmonization
There are no Codex harmonization considerations since there is currently no Codex tolerance for (Z)-l 1-
Hexadecenyl Acetate pheromone residues.
4. Nonfood Re/Registrations
There are no nonfood issues at this time.
5. Risk Mitigation
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
Since there are no risk issues, mitigation measures are not required at this time for dietary risk,
occupational and residential risk, risks to nontarget organisms (plants and wildlife), or ground and surface
water contamination for this a.i. Risk to aquatic organisms will be mitigated by appropriate label
precautions.
6. Endangered Species Statement
The Agency recognizes that the use of Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
will cause no effect to endangered species because of (Z)-l 1-Hexadecenyl Acetate's low toxicity,
expected low exposure scenario (manufacturing use only), and target species specificity.
C. LABELING RATIONALE
It is the Agency's position that the labeling for Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical
Pheromone containing 95% of (Z)-l 1-hexadecenyl acetate complies with the current pesticide labeling
requirements.
1. Human Health Ha(Z)ard
a. Worker Protection Standard
This product does not come under the provisions of the Worker Protection Standards (WPS).
b. Non-Worker Protection Standard
There are no non-WPS human health hazard issues.
c. Precautionary Labeling
The Agency has examined the toxicological data base for (Z)-l 1-hexadecenyl acetate product and
concluded that the proposed precautionary labeling (i.e. Signal Word, First Aid Statement and other label
statements) adequately mitigates the risks associated with the proposed uses.
End-Use Product Precautionary Labeling: For Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical
Pheromone, "CAUTION". Harmful if swallowed, inhaled, or absorbed through skin. Causes moderate
eye irritation. Avoid contact with skin, eyes or clothing. Avoid breathing vapor. Remove contaminated
clothing and wash before reuse. Wash thoroughly with soap and water after handling.
d. Spray Drift Advisory
No spray drift advisory statement is necessary for this use
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
2. Environmental Hazards Labeling
End-Use Product Environmental Hazards Labeling: "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 sewage treatment plant authority. For
guidance contact you State Water Board or Regional Office of the EPA.
3. Application Rate
Manufacturing use only. End-use pheromone products come in a variety of formulations ranging from
controlled release plastics to automatic metered dispensers
D. LABELING
(1) Product name: Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical Pheromone
Active Ingredient:
(Z)-l 1-Hexadecenyl Acetate
Other Ingredients
95.0%
.5.0%
Total
100.00%
The product shall contain the following information:
Product Name
Ingredient Statement
Registration Number
"Keep Out of Reach of Children"
Signal Word (CAUTION)
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
V. ACTIONS REQUIRED BY REGISTRANTS
Reports of incidences of adverse effects to humans or domestic animals under FIFRA, Section 6(a)2 and
incidents of hypersensitivity under 40 CFRPart 158.690(c), guideline reference number 152-16. There
are no data requirements, label changes and other responses necessary for the reregi strati on of the end-
use product since the product is being registered after November 1984 and is, therefore, not subject to
reregi strati on. There are also no existing stocks provisions at this time.
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Z-l 1-Hexadecenyl Acetate Technical Pheromone Biopesticide Registration Action Document
vi. Appendix A
Table 4 lists the use sites for the product. The label for the product is also attached.
Table 4. Manufacturing Use Only. Regi strati on/Reregi strati on
Bedoukian (Z)-l 1-Hexadecenyl Acetate Technical
Official date registered:
Pheromone
Use Sites
Manufacturing use only. The TGAI will be used for
incorporation into end-use products intended for
agricultural application for the control of the insect
pest Diamondback moth.
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