BIOPESTICIDES REGISTRATION ACTION DOCUMENT



# Methyl Jasmo n a te

PC Code : 02 8100

U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division

February 28 , 201 3Methyl Jasmonate

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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:

................................ ................................ ................................ . 4

II. ACTIVE INGREDIENT OV ERVIEW

................................ ................................ .............. 6

III. REGULATORY BACKGROUND

................................ ................................ .................... 6

A. Classification

................................ ................................ ................................ ........................ 6

B. Food Clearances/Tolerances

................................ ................................ ............................... 6

IV. RISK ASSESSMEN T

................................ ................................ ................................ ......... 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. Environ mental Fate and Ground Water Data

................................ ................................ .......................... 12

3. Ecological Exposure and Risk Characterization

................................ ................................ ...................... 12

4

. Endangered Species Assesment

................................ ................................ ................................ .................. 12

D. E FFICACY 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. R eporting of Adverse Effects

................................ ................................ ............................ 14

B. Reporting of Hypersensitivity Incidents

................................ ................................ .......... 14

VII. APPENDIX A. Data Requirements (40 CFR Part 158)

................................ ................. 14

VIII. APPENDIX B. P roduct S pecific I nformation

. ................................ ................................ 16

IX. APPENDIX C . R eferences

. ................................ ................................ ................................ 17

X. GLOSSARY....................................................................................... 17Methyl Jasmonate

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### 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 PfeiferMethyl Jasmonate

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I. EXECUTIVE SUMMARY:

Methyl jasmonate is a new biochemical pesticide active in gredient 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 soi l treatment. Methyl jasmonate is naturally occurring and elicits plant defense responses in vulnerable seed lings. 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 defense s against extreme temperature changes and attack s by

insects , fungi and bacteria

. Me thyl jasmona te 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

a n 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 Divis ion (BPPD) determined that the data and other

information submitted for p roduct c hemistry and Tier I a cute t oxicity for methyl jasmonate

satisf y the current guideline requirements. Acceptable scientific information was submit ted for the subchronic [90

- day O ral (OCSPP 870.3100), 90

- day I nhalation (OCSPP 870.3465) and 90

- day D ermal study (OCSPP 870.3250) ], D evel opmental (OCSPP 870.3700), and Mutagenicity data requirements [In Vitro Mammalian Cell A ssay (OCSPP 870.5300 and 5375) and Ames test (OCSPP 870.5100) ] in lieu of guideline studies . BPPD determined that the information

submitted w as acceptable based on methyl jasmonate ’s toxicological and exposure profile s

. Additionally

, this compound is non

- toxic to humans or to target pests , biodegrades readily , and

in tended application levels are below levels identified in commonly consumed food s
, thus, the Agency conclud es that there will be little or no risk s from exposure to this active ingredient. Although the data requirements were satisfied for the new active ingredient, methyl jasmonate

, BPPD notes that s hould future intended end

- use product ( EP ) applications result in different anticipated exposures to humans, the se data requirements may need t o be re addressed.

T he Agency has ac cepted the waiver rationales f or the following required ecotoxicity studies:

A cute Avian Dietary (OCSPP 850.2200); Fish Acute Toxicity (OCSPP 850.1075); Acute Aquatic Invertebrate ( OCSPP 850.1010); Terrestrial Plant (See dling Emergence) (OCSPP 850.4100); Terrestrial Plant (Veg etative Vigor) (OCSPP 850.4150) and Nontarget Insect (OCSPP 880.4350). The rationales were based on a lack of exposure and toxicity. Foremost

,

m ethyl 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, d ue to the directed application methods proposed for this active ingredient ( seed tr eatment and in

- furrow drenching )

e xposure s are ex pected to be very low

. T hese particular application methods greatly diminish exposure from drift and runoff. Additionally, a guideline study for A cute O ral Bobwhite Quail (OCSPP 850.2100) was found acceptable and confirmed non

- guideline information

demons trating methyl j asmonate’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 a cute t oxicity data for methyl jasmonate , the active ingredient is toxicity category

III. EPA has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, orMethyl Jasmonate

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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 interes t of the public to issue registration s 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

- R R) , 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 satisf y 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 registrati on decisions be fore they occur. According to this policy, EPA provide s 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 m ay be substantial public interest.

Consistent with the policy of making registration actions more transparent, methyl jasmonate i s subject to a 15

- day comment period as a “new active ingredient.” EPA is affordig a comment period of 15 days because of me thyl 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

Bio pesticides Registration Action Document (BRAD) and draft produc t 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), contain ing 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.Methyl Jasmonate

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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: 02 8100

Type of Pesticide: Biochemical Pesticide

- Systemic Acquired Resistance (SAR)

Inducer

III. REGULATORY BACKGROUND

On December 1 , 20 11 , EPA received an application filed by Becker Underwood, Inc., 801 Dayton Avenue, P.O. Box 667, Ames, IA

, 50010

, to register the product s Methyl Jasmonate Technical Grade (EPA File Symbol No. 71840

- RN) and Tariss (EPA File Symbol No. 71840

- RR)

, co ntaining 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 o n June 27, 2012 (7 7 FR 38285 )

. No comments were received following this publication

.

A. Classification

On April 13

, 2010

, the OPP Biochemical Classification C ommittee 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. F ood Clearances/Tolerances

The applicant filed a petition (PP 1 F7 941 ) 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 con centrations than those resulting from the proposed application rates , and oral toxicity data demonstrate non

- toxicity to mammals via oral routes of exposure. The F inal R ule, supporting the exemption from theMethyl Jasmonate

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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 i ngredient intended for use as a SAR

inducer for seedlings

. It is a der ivative of a class of volatile organic compounds known as jasmonates, which are ubiquitous in most plants

, but are particular ly 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 a biotic stresses and to r egulate 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 pat hways that increase plant

toler ance to temperature changes

, as well as attack by insects. Signals from methyl jasmonate are also known to l ead to production of antifungal and/or antibacterial compounds.

Methyl j asmonate 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 ( JEC FA, 2005)

. I ts use as a fragrance is permitted in candles, incense, soaps, shampoos , and lotions. I t is commonly used as a fl avor agent for processed foods with plum, peach and tropical fruit flavors

. J asmine extract, which contains significant concentrations of methyl jasmonate, is also used regularly i n 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 , a ll product chemistry data requirements for registration of methyl jasmonate have been

satisfied.

For more information regarding product chemistry da ta 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 Cat egory I indicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity

.Methyl Jasmonate

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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)

determi ne the potential for skin sensitization (allergic contact dermatitis).

Tier I acute toxicity studies submitted and reviewed demonstrate that methyl jasmonate is Toxicity C ategory III ( slightly toxic ) compound via acute or al route of exposure , based on

t esting at a limit dose of 5 000 mg a.i./kg in rat s, m ethyl jasmonate falls in Toxicity Category I V (not toxic) for acute dermal toxicity , acute inhalation toxicity, primary eye irritation and primary

dermal irritations

. Methyl jasmonate is not a dermal sens itizer. 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 te st substance for a period of ninety days

.

The applicant submitted sufficient information on methyl jasmonate to satisfy requirements for

Subchro nic T oxicity testing [ i.e. 9 0

- day O ral (O CS PP 870.3100)

, 90

- day I nhalation (O CS PP

870.3465 ) and 90

- day D ermal (OCSPP 870.325 0) ] . 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 propo sed 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

con sumption 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 derma l 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.Methyl Jasmonate

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vi. T here is a long history of safe inhalation exposure to methyl jasmonate because it is a naturally occurring volatile component of common plants. Th e 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 (Me morandum 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 r efer to Tabl e 3 in Appendix A f or more information on the subchronic data requirements

.

c. Developmental Toxicity and Mutagenicity

The applicant submitted sufficient information on methyl jasmonate to satisfy requirements for

D evelopmental T oxicity and M utagenicity [ i.e. Prenatal Developmental T oxicity (OCSPP 870.3700), B acterial R everse M utation (OCSPP 870.5100)

, I n V itro M ammalian C ell G ene
M utation (OCSPP 870.5300) and I n V itro M ammalian C hromosome A berration (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, strawberrie s 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 j asmonate is well below the average exposure for women of child

- bearing age from the consumption o f 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

.Methyl Jasmonate

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d. Tier II and Tier III

The biochemical pesticide Human Health Assessment data requirement s 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 t o 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 thr ough 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 c all

- 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 acti vity, 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 E DSP, 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 n o toxicolog ical endpoints were identified for this active ingredient

, a dose respon se 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 methylMethyl Jasmonate

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jasmonate are unlikely to accumulate in drinking water. In the unlikely event that exposure via drinking water d oes 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 applica tors and/or handlers. Additionally, no relevant toxicological e ndpoints 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 toxic ity 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 ar e 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 toxic ological 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 particu lar, will result from

the use of methyl jasmonate when label instructions are followed.Methyl Jasmonate

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C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards

The non

- target toxicology information subm itted 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 th ese 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 t he potential exposure to birds from use of the seed treatment or soil drenching will be less than exposures from naturally o ccurring concentrations in crops and other plants. Further, a ny e xposure from treated seeds to avian species and other seed eating organisms is low and not likely to cause toxic risk. With regard to aquatic organis ms , 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, e xposures to non

- target plants are also not anticipated. And even if non

- target pl ants

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 t o 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

det ermination. 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 criti cal habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designatedMethyl Jasmonate

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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 o f 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 h ealth 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 Balanci ng 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 warrant s 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 re cognized 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 t he technical grade active ingredient

, methyl jasmonate . Such products are not expected to cau se 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.Methyl Jasmonate

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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 wil l 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.go v/compliance/environmentaljustice/index.html

.

V I

. 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, n o additional data must be submi tted to EPA for these particular products. For new uses and/or changes to existing uses, EPA may require addition al 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 summa ry of these types of data are listed

below.

A. R eporting of Adverse Effects

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

must be submitted to EPA

.

B. Reporting of Hypersensitivity Incidents

Under t he provisions of 40 CFR Part 158.2050(d) , all incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency

.

VI I

. 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.Methyl Jasmonate

Page 15 of 19 Biopesticides Registration Action Document

TABLE 1

. Acceptable Product Chemistry Data Requirements for Methyl Jasmonate (40 CFR § 158.2030)

MRID 48656602

OPPTS G uideline N o

. Study R esults

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 I n

- house method

830.7200 Melting point/melting range 72.35 0 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 EPISuiteMethyl Jasmonate

Page 16 of 19 Biopesticides Registration Action Document

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 LD 50 = 3,129 mg/kg

III 48653901 Acceptable

Acute Dermal Toxicity

OCSPP 870.1200 LD 50 > 5,050 mg/kg

IV 48653902 Acceptable

Acute Inhalation Toxicity

OCSPP 870.1300 LC 50 > 2.23 mg/L

IV 4865390 3 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 § 158.206 0)

Guideline #

Test Results/ Toxicity Category MRIDs Study Conclusion

Acute Avian Oral

OCSPP 850.2100 LD 50 > 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

.Methyl Jasmonate

Page 17 of 19 Biopesticides Registration Action Document

IX

. A ppendix 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 Pesticid e 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 Organizati on.

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 p lant 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. M ethyl 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. a ctive i ngredient

BPPD Biopesticides and Pollution Prevention DivisionMethyl Jasmonate

Page 18 of 19 Biopesticides Registration Action Document

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

EC 50 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 a ir 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 Foo d, 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

LC 50 median lethal co ncentration. 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 wa ter (e.g. mg/L)

. LD 50 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 nanomete r NOEL no

- observed

- effect

- level

NOF notice of filing

NOR notice of receiptMethyl Jasmonate

Page 19 of 19 Biopesticides Registration Action Document

OPP Office of Pesticide Programs

O CSPP 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