BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Ethyl-2E,4Z-decadienoate

(Pear Ester)

PC Code: 144022

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

(last updated August 7, 2013)
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Table of Contents

I. EXECUTIVE SUMMARY .................................................................................................. 5

II. ACTIVE INGREDIENT OVERVIEW............................................................................... 6

III. REGULATORY BACKGROUND...................................................................................... 6

A. Application for Pesticide Registration ............................................................................... 6

B. Food Clearances/Tolerances............................................................................................... 6

IV. RISK ASSESSMENT ........................................................................................................... 7

A. Product Analysis Assessment (40 CFR § 158.2030).......................................................... 7

B. Human Health Assessment.................................................................................................. 8

1. Tier I Toxicology ...........................................................................................................................................8

2. Tier II and Tier III Toxicity Studies............................................................................................................9

3. Effects on the Endocrine System..................................................................................................................9

4. Dose Response Assessment .........................................................................................................................10

5. Drinking Water Exposure and Risk Characterization ............................................................................10

6. Occupational, Residential, School and Day Care Exposure and Risk Characterization ......................10

a. Occupational Exposure and Risk Characterization.................................................................................10

b. Residential, School and Day Care Exposure and Risk Characterization...............................................10

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation...........................11

a. Food Exposure .............................................................................................................................................11

b. Drinking Water Exposure ..........................................................................................................................11

c. Other Non-occupational Exposure ............................................................................................................11

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity .....................................11

9. Determination of Safety for United States Population, Infants and Children .......................................11

10. Risk Characterization .................................................................................................................................12

C. Environmental Assessment ............................................................................................... 12

1. Ecological Hazards......................................................................................................................................12

2. Environmental Fate and Ground Water Data..........................................................................................13

3. Ecological Exposure and Risk Characterization ......................................................................................13

4. Endangered Species Assessment ................................................................................................................13

D. Product Performance Data ............................................................................................... 14

V. RISK MANAGEMENT DECISION................................................................................. 14
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A. Determination of Eligibility for Registration .................................................................. 14

B. Regulatory Decision........................................................................................................... 14

C. Environmental Justice ....................................................................................................... 15

VI. ACTIONS REQUIRED BY REGISTRANTS ................................................................. 15

A. Reporting of Adverse Effects............................................................................................ 15

B. Reporting of Hypersensitivity Incidents.......................................................................... 15

VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U) .......... 16

VIII. APPENDIX B. REFERENCES ....................................................................................... 19

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 21
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Clara Fuentes, Ph.D., Entomologist

Regulatory Action Leader

Gina Burnett, M.S.
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I. EXECUTIVE SUMMARY

Ethyl-2E,4Z-decadienoate (pear ester) is a naturally occurring, volatile substance emitted from 

mature, ripening fruit, that is particularly attractive to the codling moth (CM), Cydia pomonella.

This species of moth is a major agricultural pest of pome fruit worldwide (Ref. 1). Both male and 

female moths have receptors for pear ester in their antenna, which attracts them to ripening fruit 

where they can mate and their eggs will be laid in the fruit. Synthetic pear ester is structurally 

and functionally identical to its natural counterpart, and its intended pesticidal use is to disrupt 

the CM mating behavior by confusing the moths and attracting them away from the fruit, and 

reducing their chances of finding mates and laying eggs in fruit orchards. 

The manufacturing-use pesticide product, Pear Ester Technical Grade (EPA File Symbol No. 

52991-ET), is proposed to be registered. This product contains pear ester at 93.4% and is 

intended for formulating end-use products that will be applied pre-harvest, as a foliar spray or 

contained within polymeric dispensers, to pome fruit orchards in agricultural settings where 

codling moths appear in order to disrupt their normal mating patterns. 

Data derived from appropriate tests give no indication that pear ester is toxic or pathogenic to 

humans. No unreasonable adverse effects to humans are expected from its use as a codling moth 

mating disruptor. Furthermore, pesticide products containing pear ester are not likely to pose a 

risk to the environment, including nontarget organisms. 

On October 1, 2009, the U.S. Environmental Protection Agency (EPA or the Agency) announced 

a policy to provide a more meaningful opportunity for the public to participate in major 

registration decisions before they occur. According to this policy, EPA provides a public 

comment period prior to making a registration decision for the following types of applications: 

new active ingredients; first food uses; first outdoor uses; first residential uses; or any other 

registration actions for which EPA believes there may be significant public interest. 

Consistent with the policy of making registration decisions more transparent, the public is 

provided 15 days in which to submit comments to the Agency regarding its pending decision to 

register pear ester as a new pesticide active ingredient, including its first food use and first 

outdoor use. The following documents are available for comment in the docket, identification 

number EPA-HQ-OPP-2011-1031: this draft Biopesticides Registration Action Document 

(BRAD) and the draft product label for Pear Ester Technical Grade (EPA File Symbol 52991-

ET), accessed through either http://www.regulations.gov or 

http://www.epa.gov/pesticides/regulating/registration-status.html.

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: Pear Ester

Chemical Names: Ethyl-2E,4Z-decadienoate

Trade & Other Names: Pear Ester Technical Grade

CAS Registry Number: 3025-30-7

OPP Chemical Code: 144022

Type of Pesticide: Biochemical Pesticide – Mating Disruptor 

Biochemical Classification

To be classified as a biochemical pesticide, an active ingredient must be naturally occurring and 

have a non-toxic mode of action on their targeted pests. As a structural and functional mimic of 

naturally occurring ethyl-2E,4Z-decadienoate, with a non-toxic mode of action (mating 

disruption by confusion) towards the target pest, pear ester meets the qualifications to be 

classified as a biochemical pesticide. 

For more information regarding product chemistry data requirements, please refer to Tables 1 

and 2 in Appendix A.

III. REGULATORY BACKGROUND

A. Application for Pesticide Registration

On July 12, 2011, Wagner Regulatory Associates, Inc., on behalf of Bedoukian Research, Inc.

(hereafter referred to as “Bedoukian” or “applicant”), 21 Finance Drive, Danbury, CT, 06810,

submitted applications to register a new biochemical pesticide product, Pear Ester Technical 

Grade (EPA File Symbol No. 52991-ET), containing ethyl-2E,4Z-decadienoate (pear ester) as 

the active ingredient. The product is intended to be used to manufacture end-use pesticide 

products that cause mating disruption in codling moths in pome fruit orchards. A notice of 

receipt (NOR) of the applications was published in the Federal Register on February 29, 2012,

(77 FR 12295). No comments were received during the 30-day comment period following 

publication of the NOR.

B. Food Clearances/Tolerances 

On July 12, 2011, Wagner Regulatory Associates, on behalf of Bedoukian, filed a petition (PP 

1F9701) proposing to establish an exemption from the requirement of a tolerance for residues of 

Pear Ester in or on all food commodities. A notice of filing (NOF) was published in the Federal 

Register on March 14, 2012 (77 FR 15012). No comments were received regarding pear ester 
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during the 30-day comment period following the publication of the NOF. 

Pear ester is an approved additive listed by the U.S. Food and Drug Administration (FDA) on the 

Everything Added to Food in the United States (EAFUS) list (Ref. 2). It has an intensely fruity 

flavor and is used in candies and other processed foods. The average daily intake of pear ester 

reported by the Joint Food and Agriculture Organization of the United States/World Health 

Organization Expert Committee on Food Additives is 34μg in Europe and 3μg in the United 

States. JECFA has determined that current intake of pear ester poses no safety concerns (Ref. 1). 

Foliar sprays of pear ester that reach the fruit are expected to degrade over the course of the 

season prior to harvest because this biochemical is a volatile kairomone (Henry's Law Constant 

estimated 7 x 10-4 atm m3

/mol) that dissipates rapidly in the environment and undergoes 

degradation in the presence of air and light (Ref. 1). However, assuming a foliar spray worst case 

scenario (no volatilization or degradation), the potential dietary exposure of pear ester has been 

calculated as 6.4μg in unwashed fruit. When the product is to be released over time 

(volatilization) from a polymeric dispenser attached to the tree branch, a worst case scenario 

indicates 0.16 μg pear ester in unwashed fruit (Ref. 3). Therefore, consumption of pear ester as a 

result of pesticidal exposure is not expected to exceed the current exposure to pear ester as a 

flavoring agent. 

Based on information submitted in support of the tolerance petition, and the comprehensive risk 

assessment conducted by the Agency, EPA concludes that there is a reasonable certainty of no 

harm from aggregate exposures to pear ester, including the consumption of food treated with this 

active ingredient in accordance with label directions and good agricultural practices. EPA has 

made this determination for the following reasons: (1) available toxicology data and information 

indicate that the active ingredient is of low acute toxicity and is not a likely developmental 

toxicant, mutagen, or toxic via repeat oral exposure (2) available information from the scientific 

literature indicates that humans are already exposed to pear ester in their diet from foods that 

naturally contain the chemical and from foods to which the chemical has been added as higher 

levels.

IV. RISK ASSESSMENT

A. Product Analysis Assessment (40 CFR § 158.2030)

Biochemical pesticide product analysis data requirements include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics. Product 

chemistry and composition data include information about the identity of the active ingredient, 

the manufacturing process, and discussion of the potential for formation of unintentional 

ingredients. Analysis and certified limits data include information on analysis of samples and 

certification of limits. Physical and chemical characteristics data describe basic characteristics of 

the registered pesticide products, including color, physical state, odor, stability, miscibility, pH, 

corrosion characteristics, viscosity and density.

EPA assigned a unique PC code (144022) to pear ester, and all product analysis data required for

an unconditional registration have been fulfilled. 
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Refer to Table 1 in Appendix A for a summary of product chemistry and composition, analysis 

and certified limits data. Refer to Table 2 in Appendix A for a summary of physical and chemical 

characteristics data.

B. Human Health Assessment

1. Tier I Toxicology 

Adequate mammalian toxicology data and information are available to support registration of

pear ester as a biochemical pesticide. All toxicology data requirements for pear ester have been 

satisfied, and are summarized below (see also Table 3 in Appendix A of this document).

Acute Toxicity (OCSPP Guideline Nos. 870.1100, 870.1200, 870.1300, 870.2400, 870.2500, 

and 870.2600; Master Record Identification (MRID) Nos. 48538708, 48538906, 48975101):

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the 

dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes, and 3) 

determine the potential for skin sensitization (allergic contact dermatitis). Acute toxicity 

categories I, II, III, or IV are assigned to an active ingredient and end-use product(s) containing 

that active ingredient, and are based on the hazard(s) identified from studies and/or other 

information submitted to support the application to register an active ingredient and on file with 

the Agency. Toxicity Category I indicates the highest toxicity, and Toxicity Category IV 

indicates the lowest toxicity.

The applicant submitted data on two pear ester analogs, ethyl-2,4,7-decatrienoate and methyl-2-

nonenoate, in order to fulfill the biochemical pesticide date requirements for Acute Toxicity. 

These two compounds are structural and functional analogs of pear ester, according to the 

Research Institute for Fragrance Materials (RIFM), and are expected to have biochemical 

pathways comparable to pear ester (Ref. 4). RIFM categorizes pear ester and the two analogs as 

“Ester/Simple C1-C4 Alcohol Straight Chain Ester/Unsatured/α, β-Unsaturated (Ref. 4).” Based 

upon data on ethyl-2, 4, 7-decatrienoate and methyl-2-nonenoate, pear ester is estimated to have 

an Acute Oral Toxicity (rat) of LD50 > 4,027 mg/kg (Ref. 4). Researchers have found a nearly 

100% concordance between results of oral and dermal routes for over 1,600 substances where 

the oral LD50 > 2,000 mg/kg (Ref. 4). Therefore, the Agency predicts the Acute Dermal 

Toxicity (rat) of pear ester to be LD50 > 2,000 mg/kg. 

The applicant provided scientific rationale to fulfill the data requirement of Acute Inhalation 

Toxicity: Pear ester has a low vapor pressure (0.173 mm Hg) and is 137 times less volatile than 

water at 25°C (Pear ester volatility = 23.8 mm Hg at 25oC. Maximum manufacturing operating 

temperatures are 110 °C and 50 °C, which is much lower than its boiling point (258.4 °C). This 

information suggests that airborne concentrations of Pear ester will be minimal and unlikely to 

pose potential risk from inhalation exposure in the work place. In addition, Bedoukian, Inc., has 

produced pear ester for more than 30 years for non-pesticide uses with no reported worker 

related adverse effects (Ref. 4). 

Acute toxicity data on pear ester submitted by the applicant indicate Primary Eye Irritation 
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(rabbit): moderately irritating; Primary Dermal Irritation (rabbit): non-irritant; and Dermal 

Sensitization (guinea pig): not a dermal sensitizer (Ref. 4). 

Subchronic Toxicity, Developmental Toxicity, and Mutagenicity Testing (Tier I) (OCSPP 

Guideline Nos. 870.3100, 870.3250, 870.3465; 870.3700, 870.5100, 870.5300, 870.5375; 

MRID Nos. 48975101, 48975102):

The applicant submitted scientific rationale to fulfill Subchronic Toxicity, Developmental and 

Mutagenicity Tier I testing data requirements. The rationale states that 1) pear ester is ubiquitous 

in nature and the maximum amount of pear ester recommended for foliar application (1.2 grams 

pear ester per acre per month) is about three times less than the natural background levels 

reported for pear ester release in a typical orchard (3.712 grams of pear ester per acre per month) 

(Ref. 1, Ref. 3); 2) the maximum amount of pear ester recommended for a dispenser treatment 

program is about three times more than the amount that can be expected from natural 

background emissions (about 12g pear ester per acre per month) but results of a theoretical air 

concentration calculation show pear ester levels of only 0.0008 ppm within the orchard (Ref. 3); 

3) pear ester dietary pesticidal exposure is not expected to exceed the current exposure to pear 

ester as a flavoring agent (Ref. 3, Ref 4.) ; 4) pear ester is a volatile kairomone (Henry's Law 

Constant estimated 7 x 10-4 atm m3

/mol) that dissipates rapidly in the environment and 

undergoes degradation in the presence of air and light (Ref. 1); 5) pear ester is structurally 

similar to straight chain lepidopteran pheromones (unbranched aliphatic chains between 9 and 18 

carbons ending in an alcohol, aldehyde, or acetate functional group and containing up to three 

double bonds in the aliphatic backbone), which have well documented low toxicity (Ref. 5); and 

6) has a non-toxic mode of action (Ref. 1); and 7) data submitted to fulfill the requirements for 

Acute Toxicity data indicate that pear ester is of low toxicity (Unit B. 1. a., above). 

2. Tier II and Tier III Toxicity Studies

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III 

were not required due to the low toxicity of the active ingredient and the low levels of exposure 

expected from its intended uses in EP products.

3. Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.
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Between October 2009 and February 2010, EPA issued test orders and data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Pear ester is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA section 408(p), the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders and data call-ins for all 

pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

4. Dose Response Assessment

No toxicological endpoints were identified for this active ingredient; therefore, a dose-response 

assessment was not required. 

5. Drinking Water Exposure and Risk Characterization

No significant exposure from drinking water is expected when pear ester is used according to the 

product label directions. The active ingredient is a naturally occurring component of the human 

diet and biodegrades rapidly in the environment. Its proposed use requires low application rates,

and will not be directly applied to water, so residues of pear ester are unlikely to accumulate in 

drinking water. In the event that exposure to pear ester via drinking water occurs, human health 

risks are expected to be minimal due to its low toxicity.

6. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization

a. Occupational Exposure and Risk Characterization

Agricultural treatments of pome fruit orchards with pear ester are limited to pre-harvest 

applications, and appropriate PPE requirements on end-use product labels will mitigate any 

potential exposure to applicators and/or handlers. Additionally, no relevant toxicological 

endpoints have been identified. Based on the data and information available to the Agency, 

anticipated exposure is not likely to result in unreasonable risk to humans. 

b. Residential, School and Day Care Exposure and Risk Characterization

Exposure to pear ester from its pesticidal uses in residential, school, and day care areas will be 

minimal, as the active ingredient is intended only for use in agriculture.
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7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty of no harm to U.S. populations, including infants and children, 

from aggregate exposures to residues of pear ester when used as proposed. This includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. 

Moreover, potential non-occupational inhalation and dermal exposure is not likely to pose any 

adverse effects to exposed populations via aggregate and cumulative exposure.

a. Food Exposure 

Dietary exposure of pear ester is already occurring, given that this substance is used as a 

flavoring agent in many foods commonly consumed by humans (for its intensely fruity flavor) 

and is emitted naturally from mature, ripening fruit, including Bartlett pears and concord grapes 

(Ref. 1). In addition, the proposed rates of application for use of pear ester as a codling moth 

mating disruptor, under worst case scenarios, are not expected to produce dietary exposure to 

pear ester exceeding that of current exposure due to use of pear ester as a flavoring agent (Ref. 3, 

Ref. 4). 

b. Drinking Water Exposure 

Polymer dispenser products containing pear ester would not result in water residues because the 

product would be volatizing from the dispenser, dissipating, and degrading rapidly. Foliar spray 

products containing pear ester are intended for use at rates of less than one gram of active 

ingredient per acre with no direct applications to bodies of water. Therefore, drinking water 

exposure from the proposed used pattern is not expected to pose incremental risk to adults, 

infants and children via drinking water consumption (Ref. 4).

c. Other Non-occupational Exposure 

Non-occupational dermal exposure to pear ester when used as a codling moth mating disrupter is 

considered negligible because agricultural treatments of pome orchards are limited by label 

directions to pre-harvest applications (Ref. 4). Non-occupational dermal exposure via treated 

food commodities is not greater than naturally occurring background levels of pear ester and not 

greater than exposure due to use of pear ester as a food additive (Ref. 4).

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity

 

Pear ester has no demonstrated toxicity, and there are no other pear ester-based products 

registered as pesticides; thus, there is no reason to expect cumulative effects of exposure to Pear 

Ester and to other substances with common mechanism of toxicity.

9. Determination of Safety for United States Population, Infants and Children

Pear ester is a synthetic compound that is structurally identical to, and mimics the naturally 

occurring form which is ubiquitous in nature and is responsible the characteristic aroma of pears 

and other fruits. Synthesized pear ester is structurally identical to naturally occurring pear ester. 
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Therefore, as with straight chain lepidopteran pheromones, the Agency does not distinguish 

between the synthesized kairomone and its naturally occurring form with regards to physicalchemical characteristics or toxicology. The available data and information on pear ester indicate 

that the chemical (1) is of low toxicity and not a likely developmental toxicant, (2) naturally 

occurs in the human diet, and (3) has been approved by FDA for use in foods as a food additive 

without limitation. When compared to the amount of pear ester that is likely already consumed in 

the human diet, dietary exposure from pesticidal use is not anticipated to significantly increase 

overall dietary exposure of infants and children. 

Therefore, it is expected that no harm will result from aggregate exposure to the United States 

population, including infants and children, to the residues of pear ester on food commodities. 

This includes all anticipated dietary exposures and all other exposures for which there is reliable 

information. Thus, there are not threshold effects of concern and consequently, provisions 

requiring additional margin of safety do not apply. Furthermore, considerations of consumption 

patterns, special susceptibility, and cumulative effects do not apply to pesticides without a 

demonstrated significant adverse effect.

10. Risk Characterization

The Agency considered human exposure to pear ester in light of the relevant safety factors in 

FQPA and FIFRA. A determination has been made that no unreasonable adverse effects to the 

U.S. population in general, and to infants and children in particular, will result from the use of 

pear ester when label instructions are followed. 

C. Environmental Assessment

1. Ecological Hazards

The non-target toxicology information submitted by the applicant satisfies the non-target 

toxicology data requirements for pear ester and supports its registration.

Avian Oral Acute Toxicity, Avian Dietary Toxicity, Fish Acute Toxicity, Freshwater and 

Marine, and Aquatic Invertebrate Acute Toxicity (OCSPP Guideline Nos. 850.2100, 

850.2200,850.1075, and 850.1010) 

The following biochemical ecological data requirements are not required if the pesticide is 

highly volatile (estimated volatility > 5 x 10-5 atm-m3

/mol) (40 CFR 158.2060): Avian Oral 

Acute Toxicity, Avian Dietary Toxicity, Fish Acute Toxicity, Freshwater and Marine, and 

Aquatic Invertebrate Acute Toxicity (OCSPP Guideline Nos. 850.2100, 850.2200, 850.1075, and 

850.1010). The volatility of pear ester (7.54 x 10-4 atm-m3

/mol (Henry’s Law Constant at 25°C)) 

is above that value. Due to its volatility it dissipates rapidly in the environment.

Seedling Emergence and Vegetative Vigor (OCSPP Guidelines Nos. 850.4100 and 850.4150)

Pear ester is intended for formulation into EPs in which the active ingredient is contained in a 

polymeric dispenser to passively dissipate, or as a folier spray with maximum application of 24 
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grams of pear ester/acre/application. Assuming an equal, steady release of pear ester active 

ingredient over a 120-day = 4 months growing season, the respective exposures would be 24 g 

pear ester/acre/application ÷ 4 months growing season, and 15 g pear ester/acre/application ÷ 4 

months growing season = 6, which equates to 6 and 3.75 g a.i./Acre/month, respectively. Due to 

the volatility and ready photodegradability of pear ester, it is unlikely that the use of these EPs at 

the recommended rate would result in adverse effects of pear ester to non-target plants.

Non-target Insect Testing (OCSPP Guideline 880.4350)

Pear ester is a non-toxic kairomone very similar to straight chain lepidopteran pheromones. It is 

specific to lepidopteran pests, especially the codling moth, Cydia pomonella (Ref. 6). Pear ester 

also exhibits a degree of species specificity similar to that of pheromone, by being non-attractive 

to other insect species, both beneficial and pests, including eight key lepidopteran pests of pome 

fruits and other horticultural fruit and nut crops (Ref. 7). Furthermore, once it volatilizes, it 

readily undergoes oxidative photodegradation (Ref. 8). As a result, it presents no or very low 

toxicity risk to non-target insect species such as the honeybee.

2. Environmental Fate and Ground Water Data 

Environmental fate and groundwater data are not required at this time because the results of the 

nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II 

data requirements. 

3. Ecological Exposure and Risk Characterization

As stated above, pear ester exhibits a degree of species specificity similar to that of a pheromone, 

by being non-attractive to other insect species, both beneficial and pests, including eight key 

lepidopteran pests of pome fruits and other horticultural fruit and nut crops (Ref. 7). In addition, 

it is highly volatile and dissipates rapidly in the environment. Little to no exposure is expected 

for non-target organisms; however, any incidental exposures are not anticipated to be of any 

concern due to the low toxicity of this active ingredient. 

4. Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species 

determination. The ecological risk assessment planned during registration review will allow the 

Agency to determine whether the uses of pear ester have “no effect” or “may effect” federally 

listed threatened or endangered species (listed species) or their designated critical habitats. Pear 

ester is structurally identical to the naturally occurring compound produced in pome fruit. It is 

not known to be toxic to any insect species or other non-target organisms. In addition, pear ester 

exhibits a degree of species specificity similar to that of a pheromone, by not attracting other 

insect species, including beneficials and several key lepidopteran pests of pome and other fruit 

and nut crops, while being highly attractive to the codling moth, Cydia pomonella. Based on this 

information, it is unlikely that pear ester will affect listed species. Furthermore, the listed 

lepidopteran species do not share the same habitats as the targeted pest. For example, the Karner 

blue butterfly (Lycaeldes melissa samuelis) is a listed lepidopteran species that feeds exclusively 
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on wild lupine (Lupinus perennis) in oak savannas and sandy lands and thus is not likely to 

inhabit areas where the products containing pear ester as an active ingredient will be used. 

Should this species inhabit areas where pome fruits are grown, they would be exposed to 

naturally occurring pear ester; however, due to the use patterns and high volatility of pear ester, it 

would not be expected to affect this or any other listed species.

Should an assessment conclude that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Services (the Services), as appropriate. 

D. Product Performance Data

Product performance (efficacy) data must be developed for all pesticides to ensure that the 

products will perform as intended and that unnecessary pesticide exposure to the environment 

will not occur as a result of the use of ineffective products. The Agency reserves the right to 

require, on a case-by- case basis, the submission of efficacy data for any pesticide product 

registered or proposed for registration, but applications to register pesticide products intended to 

control a pest of significance public health importance, as defined in FIFRA section 28(d) and 

section 2(nn), must include such data. For further guidance on the product performance data

requirement, refer to Pesticide Registration Notice (PR) Notices 96-7, 2002-1 and Explanation of 

Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides 

(http://www.epa.gov/PR _Notices/pr1996-7.pdf) (http://www.ea.gov/PR_Notices/pr2002-1.pdf) 

and (http://www.epa.gov/pesticides/health/risk-benefit.htm).

This pear ester is not intended to be formulated into products to control public health pests as 

defined in FIFRA section 28(d) and section 2(nn), and product performance (efficacy) was not 

evaluated by the Agency. 

V. RISK MANAGEMENT DECISION

A. Determination of Eligibility for Registration 

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is 

determined that: (A) its composition warrants proposed claims; (B) its labeling and other 

materials 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. 

The four eligibility criteria have been satisfied for the proposed pesticide products containing the 

active ingredient, pear ester; therefore, pear ester is eligible to be registered for the intended uses. 

B. Regulatory Decision

The data submitted fulfill the requirements for the unconditional registration of pear ester as a 

mating disrupter for the codling moth. For product-specific information, please refer to 
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http://www.epa.gov/pesticides/pestlabels.

C. Environmental Justice

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of pear ester pesticide products will cause harm or a 

disproportionate impact on at-risk communities. For additional information regarding 

environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the new active ingredient, 

pear ester, and determined that these data are sufficient to satisfy current registration data 

requirements. At this time, no additional data must be submitted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 

A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Under the provisions of 40 CFR Part 158.2050(d), all incidents of hypersensitivity (including 

both suspected and confirmed incidents) must be reported to the Agency.
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VII. Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

NOTE: Master Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data/information for the original registration of the product 

containing this active ingredient. Subsequent to this registration, there may be additional MRIDs 

that support registration of other products containing this active ingredient. 

TABLE 1. Product Identify, Composition, Analysis and Certified Limits for Bedoukian Pear Ester Technical (40 CFR § 

158.2030) MRIDs 48538901 thru 48538903

OPPTS Guideline 

Reference No. Study Results 

830.1550

to

830.1670

Product identity;

Manufacturing process;

Discussion of formation of unintentional 

ingredients

Acceptable; Confidential Business Information 

(CBI)

830.1700 Analysis of samples Acceptable; CBI

830.1750 Certification of limits Limits listed in the CSF are adequate / acceptable.

830.1800 Analytical method Acceptable; CBI
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TABLE 2. Physical and Chemical Properties for Bedoukian Pear Ester Technical (40 CFR § 158.2030) 

 MRIDs 48538904 and 48538905 

OCSPP Guideline Reference 

No./Property

Description of Result Methods

830.6302 Color Colorless Visual inspection

830.6303 Physical State Liquid at room temperature Visual inspection

830.6304 Odor Characteristic odor of Bartlett pear Olfactory inspection

830.6313 Stability Deteriorates slightly after 14 days at 54°C. Stable 

in the presence of iron, iron acetate, aluminum, or 

aluminum acetate for 14 days at room temperature 

or 54°C.

OCSPP 860.6313

830.6314 Oxidation/Reduction: 

Chemical Incompatibility

Not applicable, the product does not contain 

oxidizing ingredients.

830.6315 Flammability Flash point >230°F Pensky Martens Closed 

Cup

830.6316 Explodability Not applicable, the product does not contain 

explosive ingredients.

830.6317 Storage Stabilityb Stable for 12 months when stored at 0°C. OCSPP 860.6317

830.6319 Miscibility Not applicable, the product is not an emulsifiable 

liquid to be diluted with petroleum solvents. -

830.6320 Corrosion Characteristicsb No changes in integrity or appearance of aluminum 

containers after 12 months storage at 0°C. OCSPP 830.6320

830.6321 Dielectric Breakdown 

Voltage

Not applicable, the product is not for use around 

electrical equipment. -

830.7000 pH Not applicable, the product is not soluble or 

dispersible in water. -

830.7100 Viscosity 4.56 cSt ASTM D445

830.7200 Melting Range Not applicable, the product is a liquid. -

830.7220 Boiling Range 258.41°C EPISuite

830.7300 Density/Relative 

Density/Bulk Density

Specific gravity = 0.903 at 25°C Anton Parr Density Meter

830.7370 Dissociation Constant in 

Water

Not applicable, the product is not soluble or 

dispersible in water. -

830.7550 Partition Coefficient 4.36 SRC Interactive PhysProp 

database

830.7840 Water Solubility 8.588 mg/L at 25°C EPISuite

830.7950 Vapor Pressure 0.0173 mm Hg at 25°C EPISuite
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TABLE 3. Acute Toxicity Data for Bedoukian Pear Ester Technical (40 CFR 158.2050)

Study Type/OPPTS Guideline LD50/LC50/Results Toxicity Category MRID

Acute Oral Toxicity/OPPTS 870.1100 4027 mg/kg a

III Firmenic,1966

Givaudan,1982

Acute Dermal Toxicity/OPPTS 870.1200 2,000 mg/kg b

III Seidle at al. 2011

Acute Inhalation Toxicity/OPPTS 870.1300 Registrant’s rationale IV 48975101

Acute Eye Irritation/OPPTS 870.2400 Moderate irritating

III

Firmenich,1996

Acute Dermal Irritation/OPPTS 870.2500 Non-irritant IV

48538906 

48538708 

Skin Sensitization/OPPTS 870.2600 Not skin sensitizer IV Givaudan, 1981

a Predicted value (estimated using the US EPA program “Toxicity estimation Software Tool” (T.E.S.T.) version 

4.1, available at http://www.epa.gov/ordntrnt/ORD/NRMRL/std/qsar.html).

b Predicted value

TABLE 4. Ecological Toxicity Data Requirements for Bedoukian Pear Ester Technical (40 CFR § 158.2060)

Guideline #

Test

Results/Toxicity Category MRID Study Conclusion

Acute Avian Oral

OCSPP 850.2100

Waiver Request 48538907 Acceptable

Acute Avian Dietary 

OCSPP 850.2200

Waiver Request 48538907 Acceptable

Fish Acute Toxicity

OCSPP 850.1075

Waiver Request 48538907 Acceptable

Acute Aquatic Invertebrate

OCSPP 850.1010

Waiver Request 48538907 Acceptable

Terrestrial Plant (Seedling Emergence) 

OCSPP 850.4100

Due to the volatility and ready 

photodegradability of pear ester, 

it is unlikely that its use would 

result in adverse effects to nontarget plants.

48538907 Acceptable

Terrestrial Plant (Vegetative Vigor) 

OCSPP 850.4150 48538907 Acceptable

Nontarget Insect 

OCSPP 880.4350

Pear ester exhibits a degree of 

species specificity similar to that 

of pheromone, by being nonattractive to other insect species.

48538907 Acceptable
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VIII. Appendix B. References

1. U.S. EPA, 2012. Memorandum from Clara Fuentes, Ph.D., to Gina Burnett. Tolerance 

Exemption Petition Review in support of registration of the following products: a) Bedoukian

Pear Ester Technical – a manufacturing use product, containing 93.4 % w/w of 2,4-

Decadienoic acid, ethyl ester, (2E,4Z); b) end use microencapsulated formulation Cidetrak 

DA-MEC, containing 5.0% w/w of Pear Ester, for foliar application to control larvae and 

adult Codling moth, Cydia pomonella, in apple, pear and walnut trees, and c) Cidetrack CMDA Combo MD polymeric dispensers: Cidetrak CM-DA 115/30, containing 115 mgs of 

Codling Moth Pheromone and 30 mgs of Pear Ester; Cidetrak CM-DA 185/60, containing 

185 mgs of Codling Moth Pheromone and 60 mgs of Pear Ester, and Cidetrak CM-DA 90/60, 

containing 90 mgs of Codling Moth Pheromone and 60 mgs of Pear Ester to control Codling 

moth, Cydia pomonella, and hickory Shuckworm, Cydia caryana, in apple, pear, walnut, 

pecan, quince, and other pome fruit trees. U.S. Environmental Protection Agency, Office of 

Pesticide Programs. June 28, 2012. 

2. U.S. FDA, 2013. Everything Added to Food in the United States (EAFUS) list. U.S. Food 

and Drug Administration (FDA), accessed on April 1, 2013. Available at: 

http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=eafusListing&id=11

83

3. Trece, 2011. Petition proposing the exemption from the requirement of a tolerance under 40 

CFR § 180 for the biochemical active ingredient Ethyl 2,4 Decadienoate (CAS 3025-30-7) 

for pre-harvest uses on all agricultural commodities. Trece, Inc. July 8, 2011. 

4. U.S. EPA, 2013. Memorandum from Clara Fuentes, Ph.D., to Gina Burnett. Science review 

of registrant’s response to deficiencies concerning Tolerance Exemption Petition in support 

of registration of Bedoukian Pear Ester Technical – a manufacturing use product, containing 

93.4 % w/w of 2,4-Decadienoic acid, ethyl ester, (2E,4Z). U.S. Environmental Protection 

Agency, Office of Pesticide Programs. January 10, 2013. 

5. U.S. EPA, 2008. Biopesticide Registration Action Document Straight Chain Lepidopteran 

Pheromones. U.S. Environmental Protection Agency, Office of Pesticide Programs. October 

2, 2008. Available at: 

http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_G-109_02-

Oct-08.pdf

6. Pasqualini, E., Villa, M., Civolani S., Espinha I., Ioriatti, C. Schmidt, S., Molinari, F., 

DeCristofaro A., Sauphanor B., and Ladurner, E., 2005. The Pear Ester Ethyl (E,Z)-2,4-

decadienoate as a Potential Tool for the control of Cydia pomonella larvae: Preliminary 

Investigation. Bull. of Insectology, Vol. 58. No. 1: 65-69.

7. Knight, A. L. and Light D. M. 2004. Use of (E,Z)-2,4-decadienoic Acid in Codling Moth 

management improved Monitoring in Bartlett Pear with high dose Lures. J. Entomol. Soc. 

Br. Columbia. 101:59–66.
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8. Heinz, D. E. and Jennings, W.G., 1966. Volatile Components of Bartlett Pear. Journal of 

Food Science. Vol 31, Issue 1: 69-80.
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IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

bw body weight

CBI Confidential Business Information

CFR Code of Federal Regulations

cm3 cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EC50 median effective concentration. A statistically derived single concentration in 

environmental medium that can be expected to cause an effect in 50% of the test 

animals when administrated by the route indicated (inhalation). It is expressed 

as a concentration in air or water (e.g. mg/L).

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

ha hectare

kg kilogram

Kow octanol-water partition coefficient

L liter

LC50 median lethal concentration. A statistically derived single concentration in air or 

water that can be expected to cause death in 50% of the test animals when 

administrated by the route indicated (inhalation and environment). It is 

expressed as a concentration in air or water (e.g. mg/L).

LD50 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 and dermal). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).

MRID No. Master Record Identification Number

mg milligram

mPa millipascal

mL milliliter

MP manufacturing-use product

N/A not applicable

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health
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nm nanometer

NOEL no-observed-effect-level

NOF notice of filing

NOR notice of receipt

OPP Office of Pesticide Programs

OCSPP Office of Chemical Safety and Pollution Prevention

pa pascal

PPE personal protective equipment

PR Notice Pesticide Registration Notice

 TGAI technical grade of the active ingredient

 ug microgram

 USDA United States Department of Agriculture

 UV ultra-violet