Document ID: EPA-HQ-OPP-2012-0134-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-02-21T05:00Z

BIOPESTICIDES REGISTRATION ACTION DOCUMENT
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                       
                               Methyl Jasmonate
                               PC Code : 028100
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       

   
	U.S. Environmental Protection Agency
	Office of Pesticide Programs
                Biopesticides and Pollution Prevention Division
                                       
                                       
                               February 28, 2013
                                       
		TABLE OF CONTENTS				
I.	EXECUTIVE SUMMARY:	4
II.	 ACTIVE INGREDIENT OVERVIEW	6
III.	 REGULATORY BACKGROUND	6
A.	Classification	6
B.	Food Clearances/Tolerances	6
IV.	  RISK ASSESSMENT	7
A.	Active Ingredient Characterization	7
B.	Human Health Assessment	7
1.	Toxicology	7
2.	Dose Response Assessment	10
     3.	Drinking Water Exposure and Risk Characterization ......................................................... 10	
4.	Occupational, Residential, School and Day Care Exposure and Risk Characterization	11
5.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation	11
6.	Cumulative Effects	11
7.   	Risk Characterization	11
C.	ENVIRONMENTAL ASSESSMENT	12
1.	Ecological Hazards	12
2.	Environmental Fate and Ground Water Data	12
3.	Ecological Exposure and Risk Characterization	12
4.	Endangered Species Assesment	12
D.	EFFICACY DATA	13
V.	Risk Management Decision	13
A.	Determination of Eligibility for Registration	13
B.	Regulatory Decision	13
VI.	 ACTIONS REQUIRED BY REGISTRANTS	14
A.  Reporting of Adverse Effects	14
B.	Reporting of Hypersensitivity Incidents	14
VII.	 Appendix A. Data Requirements (40 CFR Part 158)	14
VIII. Appendix B. Product Specific Information.	16
IX.	Appendix C. References.	17

X.     GLOSSARY.......................................................................................     17    

BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief
Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms
Miachel Rexrode, Ph.D., Senior Biologist

Regulatory Action Leader
Chris Pfeifer
I.	EXECUTIVE SUMMARY:
Methyl jasmonate is a new biochemical pesticide active ingredient intended for use as a `systemic acquired resistance' (SAR) inducer on a variety of agricultural crops. It is applied as a seed treatment and an in-furrow soil treatment. Methyl jasmonate is naturally occurring and elicits plant defense responses in vulnerable seedlings. It is the principal derivative of jasmonate, a hormone ubiquitous to most plants but particularly concentrated in jasmine and honeysuckle. Jasmonates are known to trigger plant responses to a variety of stresses. Methyl jasmonate, in particular, is known to bolster plant defenses against extreme temperature changes and attacks by insects, fungi and bacteria.  Methyl jasmonate is present in most fruits, is already a regular part of the human diet, and has a safe history of dietary exposure. Additionally, methyl jasmonate is an FAO/WHO approved flavoring agent, and is commonly consumed in processed foods with peach, apricot, berry, plum, tutti  - fruitti, and tropical fruit flavors (JECFA, 2005). 
The Biopesticides and Pollution Prevention Division (BPPD) determined that the data and other information submitted for product chemistry and Tier I acute toxicity for methyl jasmonate satisfy the current guideline requirements. Acceptable scientific information was submitted for the subchronic [90-day Oral (OCSPP 870.3100), 90-day Inhalation (OCSPP 870.3465) and 90-day Dermal study (OCSPP 870.3250)], Developmental (OCSPP 870.3700), and Mutagenicity data requirements [In Vitro Mammalian Cell Assay (OCSPP 870.5300 and 5375) and Ames test (OCSPP 870.5100)] in lieu of guideline studies. BPPD determined that the information submitted was acceptable based on methyl jasmonate's toxicological and exposure profiles. Additionally, this compound is non-toxic to humans or to target pests, biodegrades readily, and intended application levels are below levels identified in commonly consumed foods, thus, the Agency concludes that there will be little or no risks from exposure to this active ingredient. Although the data requirements were satisfied for the new active ingredient, methyl jasmonate, BPPD notes that should future intended end-use product (EP) applications result in different anticipated exposures to humans, these data requirements may need to be readdressed.

The Agency has accepted the waiver rationales for the following required ecotoxicity studies: Acute Avian Dietary (OCSPP 850.2200); Fish Acute Toxicity (OCSPP 850.1075); Acute Aquatic Invertebrate (OCSPP 850.1010); Terrestrial Plant (Seedling Emergence) (OCSPP 850.4100); Terrestrial Plant (Vegetative Vigor) (OCSPP 850.4150) and Nontarget Insect (OCSPP 880.4350). The rationales were based on a lack of exposure and toxicity.  Foremost, methyl jasmonate is ubiquitous in the natural environment and has a non-toxic mode of action, with no demonstrable toxic effect to vertebrates or invertebrates. Second, due to the directed application methods proposed for this active ingredient (seed treatment and in-furrow drenching) exposures are expected to be very low. These particular application methods greatly diminish exposure from drift and runoff.  Additionally, a guideline study for Acute Oral Bobwhite Quail (OCSPP 850.2100) was found acceptable and confirmed non-guideline information demonstrating methyl jasmonate's dietary non-toxicity. From the evidence presented by these data and rationale, the Agency concludes that there are no toxic risks to non-target organisms from the proposed pesticidal use of methyl jasmonate. 

Based on the acute toxicity data for methyl jasmonate, the active ingredient is toxicity category III. EPA has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil organisms. EPA has no concerns for any nontarget organisms exposed to methyl jasmonate when used in accordance with approved label directions. Given that methyl jasmonate has negligible toxicity and presents little, if any, risk to nontarget organisms, EPA has concluded that it is in the best interest of the public to issue registrations for the Manufacturing-use Product (MP), Methyl Jasmonate Technical Grade (EPA File Symbol No. 71840-RN) and the End-use Product (EP) Tariss (EPA File Symbol No. 71840-RR), which contain this new active ingredient, methyl jasmonate.

BPPD has reviewed the data and information submitted in support of the request for registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It has been determined that the data and information submitted adequately satisfy current biochemical pesticide guideline requirements (please refer to 40 CFR Subpart U § 158.2000). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to participate on 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 use, first outdoor use, first residential use; and any registration decisions for which the Agency believes there may be substantial public interest.  

Consistent with the policy of making registration actions more transparent, methyl jasmonate is subject to a 15-day comment period as a "new active ingredient." EPA is affordig a comment period of 15 days because of methyl jasmonate's negligible toxicity, the determination that methyl jasmonate presents low risk of any adverse effects to human health and the environment, and the utility of this active ingredient. The notice for this comment period includes the draft Biopesticides Registration Action Document (BRAD) and draft product labels for the EPA File Symbol No. 71840-RN and EPA File Symbol No. 71840-RR), which contain this new active ingredient, methyl jasmonate. The docket identification (ID) number is EPA-HQ-OPP-2012-0134. The Agency believes that based on the risk assessment and information submitted in support of the registration of the MP, Methyl Jasmonate Technical Grade (EPA File Symbol No. 71840-RN), and the EP, Tariss (EPA File Symbol No. 71840-RR), containing methyl jasmonate, it is in the best interests of the public to issue the registration for Methyl Jasmonate Technical Grade and Tariss. The basis for this decision can be found in the risk assessment for methyl jasmonate, which is characterized in this BRAD.  

                                        
II.		ACTIVE INGREDIENT OVERVIEW

   Common Name: 			Methyl Jasmonate
   
      Chemical Names:            Cyclopentaneacetic acid, 3-oxo-2-(2-pentenyl)-,methyl ester
 
   Trade & Other Names: 	Methyl Jasmonate Technical Grade, Jasmonate 

      CAS Registry Number: 	1211-29-6
   
   OPP Chemical Code: 	028100

   Type of Pesticide:            Biochemical Pesticide - Systemic Acquired Resistance (SAR)
								Inducer

III.		REGULATORY BACKGROUND

On December 1, 2011, EPA received an application filed by Becker Underwood, Inc., 801 Dayton Avenue, P.O. Box 667, Ames, IA, 50010, to register the products Methyl Jasmonate Technical Grade (EPA File Symbol No. 71840-RN) and Tariss (EPA File Symbol No. 71840-RR), containing the new biochemical active ingredient, methyl jasmonate. A notice of receipt (NOR) of this application, allowing for a 30-day comment period, was published in the Federal Register on June 27, 2012 (77 FR 38285). No comments were received following this publication.

A.	Classification

On April 13, 2010, the OPP Biochemical Classification Committee determined that methyl jasmonate is a naturally occurring plant hormone and SAR-inducer. This plant hormone's non-toxic mode of action works by triggering plant immuno-defenses when seedlings are stressed. These responses help protect the seedlings against insects, fungi, and bacteria.  

B.	Food Clearances/Tolerances 

The applicant filed a petition (PP 1F7941) proposing to establish an exemption from the requirement of a tolerance for residues of methyl jasmonate in or on all food commodities. A notice of filing (NOF), allowing for a 30-day comment period, was published in the Federal Register on May 2, 2012 (77 FR 25954). No comments were received following this publication. The Agency determined in its subsequent review of the active ingredient, methyl jasmonate, that the data submitted support an exemption from the requirement of a tolerance for residues of methyl jasmonate in and on all food commodities. Residues of proposed applications of methyl jasmonate are less than the concentrations found naturally in many fruit. Additionally, methyl jasmonate is an FAO/WHO-approved flavor agent allowed in greater concentrations than those resulting from the proposed application rates, and oral toxicity data demonstrate non-toxicity to mammals via oral routes of exposure. The Final Rule, supporting the exemption from the requirement, is expected to be published immediately after the closing of the Public Participation Process. 

IV.			RISK ASSESSMENT
 
A.	Active Ingredient Characterization
Methyl jasmonate is a new biochemical pesticide active ingredient intended for use as a SAR-inducer for seedlings. It is a derivative of a class of volatile organic compounds known as jasmonates, which are ubiquitous in most plants, but are particularly concentrated in jasmine and honeysuckle. Jasmonates are known to act as plant hormones. In particular, methyl jasmonate is known to trigger plant responses to biotic and abiotic stresses and to regulate such processes as wound responses. Methyl jasmonate is produced as a reaction to stress and serves as a signal, in the form of a chemical vapor, to turn on natural plant defense pathways that increase plant tolerance to temperature changes, as well as attack by insects. Signals from methyl jasmonate are also known to lead to production of antifungal and/or antibacterial compounds.  
Methyl jasmonate is extremely fragrant and carries a distinctive and desirable flavor. It is used as both a fragrance and a flavor agent. A joint FAO/WHO committee evaluated methyl jasmonate and deemed it non-toxic when used as a flavor agent (JECFA, 2005). Its use as a fragrance is permitted in candles, incense, soaps, shampoos, and lotions. It is commonly used as a flavor agent for processed foods with plum, peach and tropical fruit flavors. Jasmine extract, which contains significant concentrations of methyl jasmonate, is also used regularly in tea and as a spice for many Mid-Eastern dishes.  
The active ingredient methyl jasmonate approximates food grade methyl jasmonate. It has a high percentage of purity, and all impurities are typical of the compound and are considered to be non-toxic. Descriptions of the product formulation and production process, formation of impurities, and physical and chemical characteristics were examined by BPPD and found to confirm the purity and to be acceptable in meeting current biochemical pesticide guideline standards. Additionally, the physical and chemical properties have all been well characterized. In sum, all product chemistry data requirements for registration of methyl jasmonate have been satisfied. 

For more information regarding product chemistry data requirements, please refer to Tables 1 and 2 in Appendix A.  
	
B.	Human Health Assessment

1.	Toxicology 

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) identified from studies and/or information on file with the Agency. The active ingredient is classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity.  

Adequate mammalian toxicology data and information are available to support registration of methyl jasmonate. All toxicology data requirements for methyl jasmonate have been satisfied.

	a.	Acute Toxicity

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).  

Tier I acute toxicity studies submitted and reviewed demonstrate that methyl jasmonate is Toxicity Category III (slightly toxic) compound via acute oral route of exposure, based on testing at a limit dose of 5000 mg a.i./kg in rats, methyl jasmonate falls in Toxicity Category IV (not toxic) for acute dermal toxicity, acute inhalation toxicity, primary eye irritation and primary dermal irritations. Methyl jasmonate is not a dermal sensitizer. No toxicological endpoints were identified for this active ingredient.  

For more information regarding acute toxicity data requirements, refer to Table 3 in Appendix A.  

 	b.	Subchronic Toxicity 
 
 Subchronic data are required to determine a no-observed-effect-level (NOEL) and any toxic effects associated with repeated or continuous exposure to a test substance for a period of ninety days.  
 
The applicant submitted sufficient information on methyl jasmonate to satisfy requirements for Subchronic Toxicity testing [i.e. 90-day Oral (OCSPP 870.3100), 90-day Inhalation (OCSPP 870.3465) and 90-day Dermal (OCSPP 870.3250)]. The information submitted was found acceptable based on the toxicological and exposure profile of methyl jasmonate, summarized below.
	
   i.    Methyl jasmonate is a naturally occurring compound found in fruits and other plants and is already consumed in the human diet. This compound has a history of safe dietary exposure (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). 
   ii.    The proposed use pattern of this product results in exposure levels that are lower than the current estimated dietary exposure (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Oral exposure of children and adults to methyl jasmonate calculated from food consumption information from the U.S. EPA Exposure Factors Handbook (U.S. EPA, 2009) were found to be less than the residues resulting from a maximum application.
   iii.    Methyl jasmonate was reviewed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 2005) and was identified as a non-toxic flavoring agent.  
   iv.    Methyl jasmonate is not known or expected to be metabolized differently following exposure by the dermal route than the oral route and a literature search yielded no reports of subchronic dermal toxicity effects in rodents or humans from methyl jasmonate exposure (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). 
   v.    Prolonged dermal exposure is not expected because the product is not purposely applied to the skin and because handlers and applicators are required to wear appropriate PPE.
   vi.    There is a long history of safe inhalation exposure to methyl jasmonate because it is a naturally occurring volatile component of common plants. The potential inhalation exposure concentration from use of products containing methyl jasmonate will be less than or equal to naturally occurring concentrations from crops and other plants (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012).
   vii.    Significant exposure to humans is not anticipated based on low application rates and rapid degradation in the environment (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). 
	
Please refer to Table 3 in Appendix A for more information on the subchronic data requirements.  

      c.   Developmental Toxicity and Mutagenicity 

The applicant submitted sufficient information on methyl jasmonate to satisfy requirements for Developmental Toxicity and Mutagenicity [i.e. Prenatal Developmental Toxicity (OCSPP 870.3700), Bacterial Reverse Mutation (OCSPP 870.5100), In Vitro Mammalian Cell Gene Mutation (OCSPP 870.5300) and In Vitro Mammalian Chromosome Aberration (OCSPP 870.5375)]. The information submitted was found acceptable based on the toxicological and exposure profile of methyl jasmonate, summarized below.

   i.    There is a long history of safe dietary exposure to methyl jasmonate because it naturally occurs in apples, strawberries and mangos (Lalel et al., 2003), fruits that are part of the normal diet. 
   ii.    The potential oral exposure to methyl jasmonate from the proposed uses of methyl jasmonate is well below the average exposure for women of child-bearing age from the consumption of fruits that naturally contain methyl jasmonate, and also well below the JECFA human exposure threshold (Munro, 1999).	
   iii.    Methyl jasmonate has been evaluated for safety by the FAO and determined to be metabolized to innocuous end-products that are eliminated in the urine (Lalel et al., 2003). 
   iv.    A literature search yields no reports of genotoxicity in laboratory studies on methyl jasmonate (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012).
   v.    Significant exposure to child-bearing women is not anticipated based on low application rates, appropriate PPE requirements on the label, and rapid degradation in the environment. 

For more information regarding developmental and mutagenicity data requirements, refer to Table 3 in Appendix A.  

	d.   Tier II and Tier III 

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III were not required due to the nature of the active ingredient and its intended uses in EP products (SAR-inducing seed treatment and soil drench).

	e.	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.

Methyl jasmonate 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/.
   
2.	Dose Response Assessment

Because no toxicological endpoints were identified for this active ingredient, a dose response assessment was not required.  

3.	Drinking Water Exposure and Risk Characterization
 
No significant exposure via drinking water is expected when methyl jasmonate is used according to the product label directions. The active ingredient biodegrades rapidly in the environment, is applied at low application rates, and is not directly applied to water; therefore, residues of methyl jasmonate are unlikely to accumulate in drinking water. In the unlikely event that exposure via drinking water does occur, the health risk would be expected to be minimal based on the low acute oral toxicity of jasmonate and the fact that methyl jasmonate is an edible compound that is ubiquitous in fruits and other edible plants.

4.	Occupational, Residential, School and Day Care Exposure and Risk Characterization

	a.	Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for methyl jasmonate, and is not required. Appropriate PPE requirements on the label 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 methyl jasmonate will be minimal in residential, school, and day care areas, as the product containing this active ingredient is intended for use on agricultural crops. 

5.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation
 
There is reasonable certainty that no harm to the U.S. population will result from aggregate exposure to methyl jasmonate. This includes all exposures for which there is reliable information. The Agency arrived at this conclusion based on the lack of toxicity of this active ingredient and the already widespread exposure without any reported adverse effects on human health. The risks from aggregate exposure via oral, dermal and inhalation exposure are a compilation of three low-risk exposure scenarios and are negligible.

6.	Cumulative Effects

 Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information concerning the cumulative effects of methyl jasmonate residues and other substances that have a common mechanism of toxicity. No toxicological endpoints have been established for exposure to methyl jasmonate; therefore, cumulative effects with other substances that share a common mechanism of toxicity are not expected. 
 
 7.   Risk Characterization
 
The Agency considered human exposure to methyl jasmonate 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 methyl jasmonate 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 methyl jasmonate and supports its registration.

The information submitted demonstrates that methyl jasmonate is practically nontoxic to birds, fish, insects and aquatic invertebrates; and is not phytotoxic. Jasmonate compounds are ubiquitous in plants and do not have a toxic mode of action. No toxic endpoints have been established for any of these non-target organisms.

For more information regarding nontarget organism toxicity data requirements, refer to Table 4 in Appendix A.  

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

Jasmonate compounds, including methyl jasmonate, are ubiquitous to all plants and are not found to have toxic effects on vertebrates, invertebrates, or plants. Additionally, little to no exposure is expected for non-target organisms due to the directed application methods. It has been established that the potential exposure to birds from use of the seed treatment or soil drenching will be less than exposures from naturally occurring concentrations in crops and other plants. Further, any exposure from treated seeds to avian species and other seed eating organisms is low and not likely to cause toxic risk. With regard to aquatic organisms, exposure is anticipated to be even more unlikely because of the terrestrial application methods - seed treatment and in-furrow application - which eliminate potential exposure from drift and runoff.  Finally, exposures to non-target plants are also not anticipated. And even if non-target plants were to be exposed, methyl jasmonate residues would not be expected to have a toxic effect since they are known bolster plant defenses. Little to no exposure is expected for non-target organisms; however, any incidental exposures are not anticipated to be of any concern as data demonstrate that methyl jasmonate is non-toxic to non-target organisms.  

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 methyl jasmonate's use has "no effect" or "may effect" federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes 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.	 EFFICACY DATA 

Product performance data must be developed for all pesticides to ensure that pesticide 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, submission of efficacy data for any pesticide product registered or proposed for registration that is intended to be used to control a pest of significance public health importance, as defined in FIFRA section 28(d) and section 2(nn). For further guidance on product performance 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).

The EP submitted with this new active ingredient did not list pests of significance public health importance or a public health pest as defined in FIFRA section 28(d) and section 2(nn). Therefore, product performance (efficacy) was not evaluated.  

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 criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science assessments supporting products containing the technical grade active ingredient, methyl jasmonate. Such products are not expected to cause unreasonable adverse effects. Therefore, methyl jasmonate, as a technical grade active ingredient, is eligible for registration for the labeled uses.  
   
B.	Regulatory Decision

The data submitted fulfill the registration requirements of methyl jasmonate for use as a SAR-inducer. Refer to Appendix B for product-specific information.

      	Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA determined that an unconditional registration of methyl jasmonate is appropriate.

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 methyl jasmonate 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 methyl jasmonate pesticide products 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. 

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. Acceptable Product Chemistry Data Requirements for Methyl Jasmonate (40 CFR § 158.2030)
                                 MRID 48656602
                             OPPTS Guideline 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. Acceptable Product Chemistry Data Requirements for Methyl Jasmonate (40 CFR § 158.2030)
                         From MRIDs 48656602-48656604
OCSPP No.
OCSPP Guideline Name
Observation
Method
830.6302
Color
TGAI: Pale yellow; EP: Colorless
Visual inspection at room temp
830.6303
Physical state
Liquid
Visual inspection at room temp
830.6304
Odor
Floral, true jasmine flower character
Olfactory inspection at room temp
830.6313
Stability to normal/elevated temps, metals and metal ions
TGAI should be fairly stable over long storage periods unless it is packaged in iron containers. The specific gravity of the samples stored at 54[0]C showed a very slight increase (1.0227 at 25[0] C).The refractive index remained constant over the 14 day test period. EP: Test underway.
GC chromatograms. Refractive index and specific gravity were measured.

830.6315
Flammability
>230[0]F
Pensky Martens closed cup
830.6317
Storage stability (EP)
Becker Underwood in-house study underway.

830.6319
Miscibility
The product is miscible in water.

830.6320
Corrosion characteristics
Becker Underwood in-house study underway.

830.7000
pH
5 - 9 at 22 [0]C
Becker Underwood in-house method
830.7050
UV/Visible absorption
max = 3.630 at 288.4 nm ; min=2.963 at 265.9 nm; max= 4.063 at 237.3 nm
(0.3083 g/10 ml methanol)
UV/VIS Spectrometer
830.7100
Viscosity
EP: 1 mPas @20[0] C
In-house method
830.7200
Melting point/melting range
72.350 C
QSAR EPISuite
830.7220
Boiling pt/boiling range
TGAI: 313.62[0] C
QSAR EPISuite
830.7300
Density/relative density/bulk density
1.02 g/ml at 20 [0]C
Anton Parr Density meter, model DMA 4500
830.7550-7570
Partition coefficient 
NA 

830.7840
Water solubility
EP water soluble. TGAI: 143.5 mg/L 
QSAR EPISuite
830.7950
Vapor pressure
Not required for end use product. TGAI: 0.000337 mm Hg
QSAR EPISuite

Table 3. Mammalian Toxicology Data Requirements for Methyl Jasmonate (40 CFR § 158.2050)
                                  Guideline #
                                     Test
                           Results/Toxicity Category
                                     MRIDs
                               Study Conclusion
Acute Oral Toxicity
OCSPP 870.1100
                              LD50 = 3,129 mg/kg
                                      III
                                   48653901
                                  Acceptable
Acute Dermal Toxicity
OCSPP 870.1200
                             LD50 > 5,050 mg/kg
                                      IV
                                   48653902
                                  Acceptable 
Acute Inhalation Toxicity
OCSPP 870.1300
                              LC50 > 2.23 mg/L
                                      IV
                                   48653903
                                  Acceptable 
                                       
Primary Eye Irritation
OCSPP 870.2400
                             Minimal eye irritation
                                      IV
                                   48653904
                                  Acceptable
Primary Dermal Irritation
OCSPP 870.2500
                                Non-irritating
                                      IV
                                   48653905
                                  Acceptable 
Dermal Sensitization
OCSPP 870.2600
                        Not a contact dermal sensitizer
                                   48653906
                                  Acceptable 
                                       
90 day Oral Toxicity-Rat
OCSPP 870.3100
                          No subchronic oral toxicity
                                   48653908
                                  Acceptable
90-day Dermal 
OCSPP 870.3250
                         No subchronic dermal toxicity
                                   48653908
                                  Acceptable
90-day Inhalation
OCSPP 870.3465
                       No subchronic inhalation toxicity
                                   48653908
                                  Acceptable
870.3700 
Prenatal Developmental Toxicity Study - Rat 
                                 Non-mutagenic
                                   48653908
                                  Acceptable 
870.5100
Bacterial Reverse Mutation Test
                                 Non-mutagenic
                                   48653908
                                  Acceptable
 870.5375 
In Vitro Mammalian Chromosome Aberration Tests 
                                 Non-mutagenic
                                   48653908
                                  Acceptable

Table 4. Ecological Toxicity Data Requirements for Methyl Jasmonate (40 CFR § 158.2060)
                                  Guideline #
                                     Test
                           Results/Toxicity Category
                                     MRIDs
                               Study Conclusion
Acute Avian Oral
OCSPP 850.2100
                             LD50 > 2,000 mg/kg
                                   48653907
                                  Acceptable
Acute Avian Dietary 
OCSPP 850.2200
                         Non-toxic to non-target birds
                                   48653908
                                  Acceptable
Fish Acute Toxicity
OCSPP 850.1075
                         Non-toxic to non-target fish
                                   48653908
                                  Acceptable 
Acute Aquatic Invertebrate
OCSPP 850.1010
                 Non-toxic to non-target aquatic invertebrates
                                  [48653908]
                                  Acceptable 
                                       
Terrestrial Plant (Seedling Emergence) 
OCSPP 850.4100
                       Non-toxic to non-target seedlings
                                   48653908
                                  Acceptable 
Terrestrial Plant (Vegetative Vigor) 
OCSPP 850.4150
                        Non-toxic to non-target plants
                                   48653908
                                  Acceptable 
                                       
Nontarget Insect 
OCSPP 880.4350
                        Non-toxic to non-target insects
                                   48653908
                                  Acceptable

VIII. Appendix B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX.	Appendix C.
                                       
REVIEWS AND OTHER REFERENCES

Memorandum from Miachel Rexrode, Ph.D, Senior Biologist to Chris Pfeifer. Review of Request for New Registration for Methyl Jasmonate Technical and Product Registration Section 3 for Scititar[TM] with Tolerance Exemption. U.S. Environmental Protection Agency Office of Pesticide Programs. July 19 2012.  

Memorandum from Miachel Rexrode, Ph.D, Senior Biologist to Chris Pfeifer. Review of Response to Deficiencies for New Registration for Methyl Jasmonate Technical and Product Registration Section 3 for Scititar[TM] with Tolerance Exemption. U.S. Environmental Protection Agency Office of Pesticide Programs. November 9 2012.  

Avanci NC, Luche DD, Goldman GH, Goldman MHS, 2010. Jasmonates are phytohormones with multiple functions, including plant defense and reproduction. Genetics and Molecular Research 9(1): 484-505.

JECFA, 2005. WHO Technical Report Series 928. Evaluation of Certain Food Additives
Sixty-third report of the Joint FAO/WHO Expert Committee on Food Additives. Section 4.1.5 Monocyclic and bicyclic secondary alcohols, ketones and related esters. World Health
Organization.

Lalel HJD, Sing Z, Tan SC. 2003. The role of methyl jasmonate in mango ripening and
biosynthesis of aroma volatile compounds. J. Horticultural Science & Biotech 78 (4); 470-484

Meyer A, Miersch O, Buttner C, Dathe W, Sembdner G. 1984. Occurrence in plant growth
regulator jasmonic acid in plants. J. Plant Growth Regul. 3:1-8.

Mukkun L & Singh Z. 2009. Methyl jasmonate plays a role in fruit ripening of `Pajaro" strawberry through stimulation of ethylene biosynthesis. Scientia Horticulturae 123:5-10.

U.S. EPA, 2009. Exposure Factors Handbook: 2009 Update. Office of Research and
Development National Center for Environmental Assessment U.S. Environmental Protection
Agency. External Review Draft. EPA/600/R-09/052A.

Walters D, Cowley T, Mitchell A. 2002. Methyl jasmonate alters polyamine metabolism and induces systemic protection against powdery mildew infection in barley seedlings. J. Exptl Botany 53:747-756.
    
 
 X.    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