Document ID: EPA-HQ-OPP-2011-1031-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-08-07T04:00Z

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)
		
                                       
                               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
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

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.

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/.

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.  

REGULATORY BACKGROUND

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.

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 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 34ug in Europe and 3ug 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 m[3]/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 6.4ug 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 ug 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.

 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. 
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.

Human Health Assessment 

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 (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 m[3]/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).   

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.

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.
	
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/.

Dose Response Assessment

No toxicological endpoints were identified for this active ingredient; therefore, a dose-response assessment was not required.  

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.

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.

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.

         c. 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). 

         d. 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).

         e. 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).

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. 

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. Therefore, as with straight chain lepidopteran pheromones, the Agency does not distinguish between the synthesized kairomone and its naturally occurring form with regards to physical-chemical 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.

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. 

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-m[3]/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-m[3]/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 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.

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.  

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. 

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 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.  
 
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.  

RISK MANAGEMENT DECISION

B. 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.  

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 http://www.epa.gov/pesticides/pestlabels.

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.

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. 

C. 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.

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. 

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

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 Stability[b]
                   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 Characteristics[b]
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

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 non-target 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 non-attractive to other insect species.
                                   48538907
                                  Acceptable

	

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 CM-DA 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=1183

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.

8. Heinz, D. E. and Jennings, W.G., 1966. Volatile Components of Bartlett Pear. Journal of Food Science. Vol 31, Issue 1: 69-80.
 
 

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
   
   cm[3] 	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
   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