BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## Prohydrojasmon

(Prohydrojasmon propyl-3-oxo-2-pe ntylcyclo-pentylacetate)

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

( last updated September 6, 2013 )Active Ingredient Page 2 of 19 Biopesticides Registration Action Document

TABLE OF CONTENTS

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

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

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

A. Classification..............................................................................................................

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

B. Food Clearances and Tolerances ........................................................................................... 6

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

.... 7

A. Active Ingredient Characterization ........................................................................................ 7

B. Human Health Assessment .................................................................................................... 7 1. Toxicology .................................................................................................................

......... 7 2. Dose Response Assessment ................................................................................................ 9 3. Food Quality Protection Act (FQPA) Considerations ........................................................ 9 4. Occupational, Residential, School and Day Care Exposure and Risk Characterization .. 10 5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation ....... 10

6. Cumulative Effects .........................................................................................................

... 11

7. Risk Characterization ..................................................................................................

...... 11

C. ENVIRONMENTAL ASSESSMENT ................................................................................ 11 1. Ecological Hazards .........................................................................................................

.. 11

2. Environmental Fate and Ground Water Data .................................................................... 11 3. Ecological Exposure and Risk Characterization ............................................................... 11 4. Endangered Species Assessment ...................................................................................... 10

D. EFFICACY DATA............................................................................................................. 1 2

V. RISK MANAGEMENT DECISION ................................................................................. 12

A. Determination of Eligibility for Registration .................................................................. 13

B. Regulatory Decision ........................................................................................................ ... 13

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 14

A. Determination of Eligibility for Registration .................................................................. 14

B. Reporting of Hypersensitivity Incidents

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

VII. APPENDIX A. Data Require ments (40 CFR Part 158) .................................................. 15

VIII. APPENDIX B. Product Specific Information..................................................19Active Ingredient Page 3 of 19 Biopesticides Registration Action Document

IX. APPENDIX C. References ................................................................................................... 19Active Ingredient Page 4 of 19 Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Linda A. Hollis, M.S., Chief Miachel Rexrode, Ph.D., Senior Biologist Gina Burnett, M.S., Acting Team Leader Leonard S. Cole, Jr., M.S., Senior Regulatory SpecialistActive Ingredient Page 5 of 19 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY:

Prohydrojasmon (PDJ) is a synthetically made plan t growth regulator that is structurally and functionally identical to jasmonic acid (JA), a naturally occurring plant regulator present in all vascular (higher) plants. As a pesticidal activ e ingredient, PDJ stimul ates fruit ripening by enhancing the red color on apple varieties that have difficulty developing color and red grapes that have difficulty developing color.

The manufacturing-use pesticid e product, Prohydrojasmin Technical (EPA File Symbol No. 62097-EI), is proposed to be registered. This product contains pr ohydrojasmin propyl-3-oxo-2- pentylcyclo-pentylacetate at 98% . Prohydrojasmin Technical is intended for formulating the enduse product, Blush, (EPA File Symbol No. 62097-EO) th at will be applied pre-harvest, as a foliar spray to apples and grapes.

Data derived from appropriate tests give no indication that PDJ is toxic to humans. No unreasonable adverse effects to humans are expected from its use as a fruit ripening agent. Furthermore, pesticide products containing PDJ are not likely to pose a risk to the environment, including non-target organisms when used according to label instructions.

On October 1, 2009, EPA announced a new policy to provide a more meani ngful opportunity for the public to participate on major registration deci sions before they occur. According to this policy, EPA provides a public comment period prio r to making a registration decision for the following types of applications: new active ingredients, first f ood use, first outdoor use, first residential use; and any regist ration decisions for which the Agency believes there may be substantial public interest.

Consistent with the policy of making registration actions more tr ansparent, PDJ is subject to a 15-day comment period as a “new active ingredie nt.” EPA has established a comment period of 15 days on the basis of PDJ’s lack of toxicity and the determination that PDJ presents low risk of any adverse effects to human health and the e nvironment. The notice for this comment period includes the draft Biopes ticides Registration Action Document (BRAD) and draft product labels for the MP, polyhydrojasmon propyl-3-oxo-2-pentyl cyclo-pentylacetate Technical, and EP, propyl-3-oxo-2-pentylcyclo-pentylacetate, which contain this new active ingredient. The docket identification (ID) number is EPA-HQ-OPP-2012-0831. The Agency believes that based on the

risk assessment and information submitted in su pport of the registrati on of the MP and EP containing prohydrojasmon pentylcycl o-pentylacetate, it is in the be st interests of the public to issue the registration for Prohydrojasmon pe ntylcyclo-pentylacet ate Technical and Prohydrojasmon pentylcyclo- pentylacetate EP. The basis for th is decision can be found in the risk assessment for Prohydrojasmon pentylcyclo-pe ntylacetate, which is characterized in this

BRAD.Active Ingredient Page 6 of 19 Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Prohydrojasmon

Chemical Names: Prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate

Trade & Other Names: Prohydrojasmon

CAS Registry Number: 158474-72-7

OPP Chemical Code: 028000

Type of Pesticide: Plant growth regulator

III. REGULATORY BACKGROUND

On June 18, 2012, EPA received an application filed by SciReg, Inc., 12733 Director’s Loop, Woodbridge, VA 22192 on behalf of Fine Agro chemicals Ltd., Hill End House, Whittington, Worcester WR5 2RQ, United Kingdom, to regi ster the products, Prohydrojasmon Technical (EPA File Symbol No. 62097-EI), and Blush EP (EPA File Symbol No. 62097-EO), containing the new biochemical active ingredient, Pr ohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate. A notice of receipt (NOR) of this application, allowing for a 30-day comment period, was published in the Federal Register on Wednesday December 16, 2012 (75 FR 11175). No comments were received following this publication.

A. Classification

On September 22, 2008, the Biochemical Cla ssification Committee determined that Prohydrojasmon propyl-3-oxo-2-pent ylcyclo-pentylacetate was “b iochemical like” and was eligible for a reduced data set. Prohydroj asmon propyl-3-oxo-2-pent ylcyclo-pentylacetate can be

classified as “biochemical like” due to its non-toxic mode of action and the compound is structurally and functionally identical to ja smonic acid (JA), a naturally occurring plant regulator.

B. Food Clearances/Tolerances

In the Federal Register of January 9, 2013, (Vol. 78 FR 1798) (FRL-9374-2), EPA issued a notice pursuant to FFDCA secti on 408(d)(3), 21 U.S.C. 346a(d)(3 ), announcing the filing of a pesticide tolerance petition (PP 2F8056) by Fine Agrochemicals Ltd. (the Petitioner), on behalf of SciReg, Inc., 12733 Director’s Loop, Woodbri dge, VA, 22192. The petition requested that 40 CFR part 180 be amended by establishing an exemp tion from the requirement of a tolerance for residues of prohydrojasmon (PDJ), propyl-3-oxo-2-pen tylcyclo-pentylacetate, in or on red apples and grapes. The notice referenced a summary of th e petition prepared by the Petitioner, which is available in the docket, http://www.regulations.gov . No substantive comments were received in response to the notice of filing.Active Ingredient Page 7 of 19 Biopesticides Registration Action Document

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

Prohydrojasmon (PDJ) is a synthetically made plan t growth regulator that is structurally and functionally identical to jasmonic acid (JA), a naturally occurring plant regulator present in all vascular (higher) plants. As a pesticidal activ e ingredient, PDJ stimul ates fruit ripening by enhancing the red color on apple varieties that have difficulty developing color and red grapes that have difficulty developing color. (EPA, 2013).

All product chemistry data requirements for registration of prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetat e have been satisfied.

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 fi le with the Agency. Th e 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/information ar e available to support registration of propyl3-oxo-2-pentylcycl o-pentylacetate

. All toxicology data requ irements for propyl-3-oxo-2- pentylcyclo-pentylacetat e have been satisfied.

a. Acute Toxicity

For acute dermal toxicity, Prohydrojasmon propyl -3-oxo-2-pentylcyclo-pen tylacetate Technical has been classified in the Toxicological Catego ry of Toxicity III. Fo r acute oral and acute inhalation, Prohydrojasmon propyl-3 -oxo-2-pentylcyclo-pentylace tate Technical has been classified in the Toxicologi cal Category of Toxicity IV. Prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate is a slight eye irritant (Toxicity Category IV) and is not a skin sensitizer or a primary skin irritant (Toxi cology Category IV). Assays for mutagenicity, chromosomal aberration, developmental toxicity, a nd subchronic oral did not present any clinical or toxicologically significant e ffects. The toxicology profile fo r the EP (Blush 5.25% ai) shows that this compound is practically non-toxic to mammals with a Toxi city Category IV as noted for
acute oral and acute inhalation toxicity studies. The acute derm al toxicity study produced an
LD 50 > 2,000 mg/kg bw (Toxicity Category III) and the primary eye irritation study produced acute symptoms after the test material was admi nistered; however, they were resolved by day 7 (Toxicity Category III). The EP is not a sk in sensitizer or a primary skin irritant.

b. Subchronic Toxicity

Subchronic data is required to determine a no-obs erved-effect-level (NOEL) and toxic effects (if any) associated with repeated or continuous exposure to a test substance for a period of 90 days No clinically or toxicologi cally significant effects were found in any treatment-group. Therefore, EPA establishes the NOAEL as the highest dose, 1,000 ppm (566 mg/kg bw/day for males and 587 mg/kg bw/day for females). A L OAEL was not established suggesting that the test animals could have tolerated a higher dose (p rotocol calls for a high test level of at least 1,000 mg/kg).Active Ingredient Page 8 of 19 Biopesticides Registration Action Document

. c. Developmental Toxicity

No treatment-related effects were found at necropsy in maternal animals nor were there effects

on copra lutei , number of implantations, sex ratio, fe tal body weight, or pre-implantation embryonic mortality. EPA does not consider th e transient decrease in body weight or food

intake as adverse and establishes the NOAEL for the study as 500 mg/kg bw/day. A LOAEL

was not identified. No treatment-related effect s were found on external examination of the fetuses. Visceral examination showed a slight increase in the incidence of thymic remnants; however, the increase was within the historical background of the performing laboratory. Therefore, EPA does not consider this a treatment -related effect. There was also a slight increase

in the incidence of a 14 th rib but this was not accompanied by an increased incidence of abnormal embryos either on external, skeletal, or viscer al examination. Additionally, no increase in the

incidence of litters with this e ffect was found. This effect is a co mmon variation in this strain of

rat and is therefore not consider ed an adverse effect. Based on the study results, the NOAEL for the study is the high-dose 500 mg/kg bw/day. A LOAEL was not identifie d. EPA has calculated the possibility of dietary exposure and concludes that in a worst case scenario (no degradation) the PDJ residues consumed by a 70 kg man are f our orders of magnitude below NOAEL that was calculated for this compound in the Devel opmental Toxicity Test (OCSPP 870.3700) (EPA, 2013).

d. Mutagenicity

No data, except to confirm that pr ohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate is not a mutagen were required due to the natu re of the active ingredient (structural and functional identity of the naturally occurring JA) and its intended use in the new EP product (ripening agent).

e. Effects on the Endocrine System

As required under Federal Food, Drug, and Cosm etic Act (FFDCA) section 408(p), EPA has developed the Endocrine Disrupt or Screening Program (EDSP) to determine whether certain substances (including pesticide ac tive and other ingredients) may have an effect in humans or wildlife similar to an effect pr oduced 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 dete rminations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substan ce to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal sy stems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will pr oceed 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 e ndocrine related effects caused by the substance, and esta blish a dose-response relationshi p between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/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 th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.

This list should not be construed as a list of known or likely endocrine disruptors.Active Ingredient Page 9 of 19 Biopesticides Registration Action Document

Prohydrojasmon propyl-3-oxo-2-pe ntylcyclo-pentylacetate 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 pest icide chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call- ins for all pesticide active ingredients.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/.

2. Dose Response Assessment

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

3. Food Quality Protection Act (FQPA) Considerations

a. Dietary Exposure a nd Risk Characterization

The most likely dietary route of exposure of humans to prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate is via exposure to treated fruit or fo liage (e.g. apples and grapes). Table 7.0 shows possible prohydrojasmon propyl-3- oxo-2-pentylcyclo-pent ylacetate residues on

various matrices after one maxi mum application of 0.009 lbs ai/A (200 ppm ai/A). The dietarybased estimated environmental concentrations range from 0.77 to 0.06 ppm on the day of application and decline to 0.0 by Day 2. This com pound is relatively unstable in the environment

with an aerobic soil half-life of 1.6 – 2.3 hours, and upon consumption breaks down in the stomach within 0.8 days.

EPA has calculated the possibility of risk to humans through dietary exposure by using a worst case scenario of maximum appli cation and no degradation. These calculations show that the prohydrojasmon propyl-3-oxo-2-pent ylcyclo-pentylacetate residue s consumed by a 70 kg person are about seven orders of magnitude below Developmental Toxicity values (NOAEL > 500 mg/kg) and about eight orders of magnitude below the Acute Oral toxicity value (LD 50 > 5,000 mg/kg), suggesting no diet ary or sublethal risk.

b

. Drinking Water Exposure and Risk Characterization

No significant exposure via dr inking water is expected wh en prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate is used in accordan ce with EPA-approved product labeling. The end product is not to be applied directly to water or to areas where surface water is present. In the unlikely event that exposure via drinking water did occur, the health risk would be expected to be minimal, based on low acute oral toxic ity of prohydrojasmon pr opyl-3-oxo-2-pentylcyclopentylacetate.

EPA estimated environmental concentrations ( EECs) to an aquatic site from prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate runo ff (spray to apple trees) using the GENeric

Estimated Environmental Concentration mode l (GENEEC; EPA, 2001). The model assumed 2 maximum applications of end product at 0.009 lbs ai/A (4g ai/A) at 7 da y intervals, a 10.7 day aquatic half-life, a 57.8 hours photod egradation half-life in water, and a 1.6 – 2.3 hour half-life inActive Ingredient Page 10 of 19 Biopesticides Registration Action Document

aerobic soil. The peak aquatic EEC was calcu lated at about 0.00048 ppm with a decline to 0.000024 ppm after 21 days. No acute or subacute endpoints were identified through mammalian testing and the expected concentrations in su rface water are well below (6 to 7 orders of magnitude) the maximum doses used in labora tory testing (e.g. Ac ute Oral Toxicity LD 50 > 5,000 mg/kg; Developmental To xicity NOAEL > 500 mg/kg).

c. Acute and Chronic Dietary Risks for Se nsitive Subpopulations Particularly Infants

and Children

FFDCA section 408 provides that the Agency sh all apply an additional tenfold margin of exposure (safety) for infants and children in the ca se of threshold effects to account for pre- and post-natal toxicity and the completeness of the database unless the Agency determines that a different margin of exposure (safety) will be sa fe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency has concluded th at there is reasonable certainty that no harm

to infants and children or a dults will result from the use of Prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate when la bel instructions are followed.

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

a. Occupational Exposure and Risk Characterization

Occupational exposure to prohydrojasmon propyl-3- oxo-2-pentylcyclo-pentylacetate is mitigated as long as the end-use product is used in acco rdance with EPA-approved labeling. Occupational exposures are not included under the Federal Food, Drug, and Cosmetic Act (FFDCA) in the assessment of aggregated exposures for the purpo se of establishing tole rances and exemptions

from tolerance.

b. Residential, School and Day Ca re Exposure and Risk Characterization

Significant exposure of prohydrojas mon propyl-3-oxo-2-pentylcyclo-pe ntylacetate to humans is highly unlikely to occur in resi dential, school and day care area s when the end use product is

used in accordance with EPA- approved labeling. The product is only intended for commercial use as a plant growth regu lator on apples and grapes.

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 residues of prohydroj asmon propyl-3-oxo-2-pentylcyclo- pentylacetate. This included all exposures for which there is reliable information. The Agency arrived at this conclusion based on lack of toxicity and rapid break-down of the compound upon consumption and into soil. The risk from aggregate exposure via oral, derm al, and inhalation are a compilation of three lowrisk exposure scenarios (oral, dermal, and inha lation) and are negligib le. Since there are no

threshold effects of concern for this com pound, and no known toxic endpoints, the provision requiring an additional margin of safety does not apply.Active Ingredient Page 11 of 19 Biopesticides Registration Action Document

6. Cumulative Effects

Residues of prohydrojasmon propyl-3 -oxo-2-pentylcyclo-pe ntylacetate will not reach levels that are of toxicological concern if the compound is used as proposed. Because of its lack of toxicity and low level of exposure, cumulative effects with other substances that share a common mechanism of toxicity are not expected.

7. Risk Characterization

The Agency considered human exposure to prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate in light of releva nt 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 prohydrojasmon pr opyl-3-oxo-2-pentylcyclopentylacetate when used in accord ance with EPA-approved labeling.

C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards

Adequate non-target toxicol ogy data/information are availabl e to support registration of prohydrojasmon propyl-3-oxo-2-pe ntylcyclo-pentylacetate

. All non-target toxicology data requirements for prohydrojasmon propyl-3-oxo-2-penty lcyclo-pentylacetate have been satisfied.

2. Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered because results of the acute toxicity studies di d not trigger any addition al Tier I studies.

3. Ecological Exposure and Risk Characterization

Prohydrojasmon propyl-3-oxo-2-pentyl cyclo-pentylacetate is not naturally-occurring but is structurally and functionally identical to jasmoni c acid (JA) which is an intermediate in the pathway to plant abscisic acid synthesis and can influence grow th inhibition, senescence, leaf abscission, as well as, a role in wound respons e and systemic resistance. When plants are attacked by insects there is a release of JA, which i nhibits the insect’s abili ty to digest protein.

In order to evaluate the risk of prohydroj asmon propyl-3-oxo-2-pent ylcyclo-pentylacetate exposure to terrestrial species, th e Agency has estimated RQ values using the Terrestrial Residue Exposure Model (T-REX) Version 1.4.1. A terrestr ial risk assessment includes calculated expected residues, as well as, numerous calcula tions of dietary exposure for multiple weight class animals (Appendix B). Expected residues we re calculated for avian and mammalian food items along with dissipation rate of a chemical applied to foliar surfa ces (single or multiple applications) in order to estimate worst case acute RQs relative to weight class for various sized

birds and mammals. These calculations showed upper bound Kenega values and that exposure to prohydrojasmon propyl-3-oxo-2-pent ylcyclo-pentylacetate (0.009 lb s ai/A) has a low potential for toxic impact to birds (RQ = 0.00) and mammal s (RQ= 0.00) that may be feeding in the area of application as noted in Appendix B. The unique characteristics of this product, prohydrojasmon propyl-3-oxo-2-pent ylcyclo-pentylacetate, and the non-toxic mode of action, biodegradability and low potential for exposure will result in no risk to all non-target terrestrialActive Ingredient Page 12 of 19 Biopesticides Registration Action Document

organisms.

Prohydrojasmon propyl-3-oxo-2-pent ylcyclo-pentylacetate exposur e to aquatic species should result in no toxicity effects. Estimated environmen tal concentrations (EECs) in aquatic sites from prohydrojasmon propyl-3-oxo-2-pentyl cyclo-pentylacetate runoff afte r application to terrestrial crops were estimated using the GENeric Es timated Environmental Concentration model (GENEEC; EPA, 2001). The model assumed 2 ma ximum applications of end product at 0.009 lbs ai/A (4g ai/A) at 7 day in tervals, a 10.7 day aquatic half -life, a 57.8 hours photodegradation half-life in water, and a 1.6 – 2.3 hour half-life in aerobic so il. The peak aquatic EEC was calculated at a peak of about 0.00048 ppm which declined to 0.000024 ppm after 21 days (Table 8.0). Since the LC 50 values for fish and aquatic invert ebrates is 3.3 mg/L and 9.54 mg/L this would result in Risk Quotients (RQs) of 0.0001 and 0.00005, respectively, which are about three and four orders of magnitude below the Ag ency’s levels of concern (LOCs = 0.05 - 1), suggesting no risk concerns for aquatic species.

4. Endangered Species Assessment

The Agency’s Individual Effects Chance Model Ve rsion 1.1 was used to estimate to the chance of risk to endangered/threaten ed avian and aquatic species from exposure to prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate. These values (avian risk at 1 in 294,000 and aquatic risk at 1 in 418,000,000) suggest that prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate should not cause toxic risk to endangered/threa tened species. In evalua ting risk to aquatic endangered species the calculated RQs are about two and three orders of magnitude below the aquatic endangered species LOC = 0.05 resulting in no effect (NE) to aquatic endangered species. The calculated RQ values for terrestrial species are 0.00 resu lting in a no effect (NE) to endangered/threatened te rrestrial organisms.

D. PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all pesticide products. Customarily, the Agency requir es efficacy data to be submitted for review only in connection with the registration of produc ts directly pertaining to the mitigation of disease bearing human health organisms and cer tain designated quarantine pests, i.e., ticks, mosquitoes, fleas, Mediterranean fr uit flies, gypsy moths, Japanese beetles, etc. For a list of organisms considered by the Agency as “publ ic health pests”, please refer to Pesticide Registration Notice 2002-1 ( http://www.epa.gov/PR_Notices/pr2002-1.pdf ).

V. Risk Management Decision

A. Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the regi stration of new active ingredients if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials required to be subm itted comply with the requirements of FIFRA; (C) it will perform its intended function w ithout unreasonable adverse effects on theActive Ingredient Page 13 of 19 Biopesticides Registration Action Document

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 Determinati on for Pesticidal Active Ingredients are satisfied by the science assessments supporting products containing active ingredient . Such products are not expected to cause unreasonable adverse effects, a nd are likely to provide protection as claimed when used according to label instructions. Therefore, prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate is eligible for registration for the labeled uses.

B. Regulatory Decision

The data submitted fulfill the registration re quirements of prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate fo r use as a ripening agent

. Refer to Appendix B for product-specific

information.

1. Conditional/Unconditional Registration

All data requirements are fulf illed, and EPA determined that an unconditional registration of prohydrojasmon propyl-3-oxo- 2-pentylcyclo-pentylac etate is appropriate.

Consistent with the policy of making regist ration actions more transparent, prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate is su bject to a 15-day comment period as a “new active ingredient.” EPA has established a comment period of 15 days on the basis of prohydrojasmon propyl-3-oxo-2-pentyl cyclo-pentylacetate minimal toxicity, the determination that prohydrojasmon propyl-3-oxo-2-pentylcyclo-pen tylacetate presents lo w risk of any adverse effects to human health and the environment, and critical need for this active ingredient. The notice for this comment period includes the dr aft Biopesticides Registration Action Document (BRAD) and draft product labels for the MP, Prohydrojasmon propyl -3-oxo-2-pentylcyclopentylacetate Technical, and EP, Blush, Prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate, which contain this new ac tive ingredient, prohydr ojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate. The docket iden tification (ID) number is EPA-HQ-OPP-2012-0831. The Agency believes that based on the risk asse ssment and information submitted in support of the registration of the MP and EP contai ning prohydrojasmon propyl -3-oxo-2-pentylcyclopentylacetate, it is in the best interests of the public to issu e the registration for Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate Tec hnical and Blush, Prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate EP. Th e basis for this decision can be found in the risk assessment for prohydrojasmon propyl-3-oxo-2- pentylcyclo-pentylacetate, which is characterized in this BRAD.

C. Environmental Justice

EPA seeks to achieve environmen tal justice—the fair treatment and meaningful involvement of all people regardless of race, color, national or igin, or income—with respect to the development, implementation, and enforcement of environmental laws, regulations, and po licies. At this time, EPA does not believe that use of prohydrojas mon propyl-3-oxo-2-pentyl cyclo-pentylacetate 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/en vironmentaljustice/index.html

.Active Ingredient Page 14 of 19 Biopesticides Registration Action Document

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the in itial registration of active ingredient and determined that these data are sufficient to satisfy current registration data requirements. No additional data are required to be submitted to the Agency at this time. For new uses and/or changes to existing uses , additional data may be required.

Not withstanding the information stated in th e previous paragraph, it should be clearly understood that certain, specific, da ta are required to be reported to the Agency as a requirement for maintaining the Federal regi stration for a pesticide product. A brief summary of these types

of data are listed below.

A. Reporting of Adverse Effects

Reports of all incidents of adverse effects to the environment must be submitted to the Agency under the provisions stated in FIFRA, Section 6(a)(2).

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hype rsensitivity (including both suspected and confirmed incidents) must be reported to the Agency unde r the provisions of 40 CFR Part 158.2050(d).Active Ingredient Page 15 of 19 Biopesticides Registration Action Document

VII. Appendix A. Data Requirem ents (40 CFR Part 158-Subpart U)

*NOTE: MRID numbers listed in the following ta bles are representative of supporting data for the original registration of the product containing this active ingr edient. Subsequent to this registration, there may be additional MRIDs that support registrati on of other products containing this active ingredient.

TABLE 1. Product Chemistry Data Requirements for BLUSH (EP) and Prohydrojasmon Tech. (40 CFR § 158.2030)
OPPTS Guideline No. Study Results (below are example results)

830.1550

to
830.1670 Product identity; Manufacturing process;

Discussion of formation of unintentional ingredients The product identity and composition were adequately addressed. Confidential Business Information (CBI).

830.1700 Analysis of samples The analysis of samples data were adequately addressed. Confidential Business Information (CBI).

830.1750 Certification of limits The certifie d limits have been adequately addressed. Confidential Business Information (CBI). 830.1800 Analytical method The Analytical method is acceptable. Confidential Business Information (CBI).Active Ingredient Page 16 of 19 Biopesticides Registration Action Document

TABLE 3.0. Physical and Chemical Properti es for BLUSH (EP) and Prohydrojasmon Tech a

Guideline Reference No./Property Description of Result Methods

830.6302 Color EP: Clear with very slight yellow coloring.

TGAI: Light yellow and clear. Visual observation at room
temperature

830.6303 Physical State EP: Clear, homoge neous mobile liquid.

TGAI: Oily liquid. Visual observation at room
temperature

830.6304 Odor EP: Sweet, fruity, solvent-like.

TGAI: No odor.

830.6313 Stability Not required for EP.

TGAI: Stable at room temperature and at 54°C for 14 days. Stable in contact with iron, zinc, aluminum,

and their acetates at room temperature and at 54°C for 14 days.

Degrades at 342°C and above. OCSPP 830.6313

OECD No. 113, 1981

830.6314 Oxidation/Reduction: Chemical Incompatibility Not applicable, the product does not contain an oxidizing or reducing agent.

830.6315 Flammability EP: flashpoint = 33.0°C.

EP: flashpoint = 33.5°C.

Not required for TGAI. Tag closed cup

Setaflash closed cup

830.6316 Explodability Not applicable, th e product is not potentially explosive and has no explosive characteristics.

830.6317 Storage Stability EP: stable at room temperature for

36 months.

Not required for TGAI. Stored in polyethylene containers in the dark at room temperature, and analyzed for active ingredient

content after 22 and 36 months.

830.6319 Miscibility Not applicable, th e product is not an emulsifiable liquid and is not to be diluted with petroleum solvents.

830.6320 Corrosion Characteristics EP: no change in appearance of

containers after 36 months of storage at room temperature in the

dark.

Not required for TGAI. Stored in polyethylene containers in the dark at room temperature, and appearance of the container

was examined after 22 and 36

months.

830.6321 Dielectric Breakdown Voltage Not applicable, th e product is not

for use around electrical equipment.

830.7000 pH EP: 6.1

TGAI: Not applicable, the product is not dispersible in water. Method based on Notification No. 71 of the Ministry of Agriculture, Forestry, and Fisheries (February 3, 1960)

830.7100 Viscosity EP: at 20°C, mean viscosity ranges from 23.9 mPa at a spindle speed of 3.0 rpm to 23.5 mPa at a spindle speed of 25.0 rpm. At 40°C, mean viscosity ranges from 8.9 mPa at a spindle speed of 8.0 rpm to 9.1 mPa at a spindle speed of 60.0

rpm. Not required for TGAI. Brookfield DVII+Pro Viscometer using a ULA adapter and spindle

830.7200 Melting Range Not applicable, the EP and TGAIActive Ingredient Page 17 of 19 Biopesticides Registration Action Document

TABLE 3.0. Physical and Chemical Properti es for BLUSH (EP) and Prohydrojasmon Tech a

Guideline Reference No./Property Description of Result Methods

are liquids.

830.7220 Boiling Range Not required for EP.

TGAI: 318°C. Differential thermal analysis (OECD No. 103, 1995)

830.7300 Density/Relative Density/Bulk Density EP: specific gravity = 0.955 at

20°C.

TGAI: 0.974 g/cm 3 at 25°C. Hydrometer method (JIS K0061)

Pycnometer (OECD No. 109, 1995)

830.7370 Dissociation Constant in Water Not required for EP.

TGAI: indeterminate. Conductometric method (OECD No. 112, 1981)

830.7550 Partition Coefficient Not required for EP.

TGAI: Not applicable, the product is partially/completely soluble in

water.

830.7840 Water Solubility Not required for EP.

TGAI: 60.2 mg/L at 25°C. Flask method (OECD No. 105)

830.7950 Vapor Pressure Not required for EP.

TGAI: 0.0167±0.00017 Pa at

25°C.

0.324±0.0221 Pa at 50°C b

. Gas saturation method (OECD No. 104, 1995)

a Data from MRIDs 47927804-10, 47927812-17, 47927843

Table 4.0. Toxicological Data for FAL 1800 5.25%ai
Data Requirement LD 50 MRIDs Study Conclusion Acute Oral Toxicity

OCSPP 870.1100 LD 50 >5000 mg/kg

IV 47927818,

47927819 Acceptable

Acute Dermal Toxicity

OCSPP 870.1200 LD 50 >2000 mg/kg

III 47927818,

47927820 Acceptable

Acute Inhalation Toxicity

OCSPP 870.1300 LC 50 > 5.0 mg/L

IV 47927818,

47927821 Acceptable

Primary Eye Irritation

OCSPP 870.2400 Acute symptoms

were observed after

test material was administered, but resolved by day 7. BLUSH produces

reversible intense eye irritation

III 47927818,

47927822 Acceptable

Primary Dermal Irritation

OCSPP 870.2500 No skin irritation.

IV 47927818,

47927823 Acceptable

Dermal Sensitization

OCSPP 870.2600 Not a dermal

sensitizer 47927818,

47927824 AcceptableActive Ingredient Page 18 of 19 Biopesticides Registration Action Document

Table 5.0. Toxicological Data for Prohydrojasmon Technical (PDJ)

Guideline #

Test Results/ Toxicity Category MRIDs Study Conclusion

Acute Oral Toxicity

OCSPP 870.1100 LD 50 > 5000 mg/kg

IV 47927818,

47927825 Acceptable

Acute Dermal Toxicity

OCSPP 870.1200 LD 50 > 2000 mg/kg

III 47927818,

47927826 Acceptable

Acute Inhalation Toxicity

OCSPP 870.1300 LC 50 > 5.0 mg/L

IV 47927818,

47927827 Acceptable

Primary Eye Irritation

OCSPP 870.2400 slight eye irritation

IV 47927818,

47927828 Acceptable

Primary Dermal Irritation

OCSPP 870.2500 No skin irritation.

IV 47927818,

47927829 Acceptable

Dermal Sensitization

OCSPP 870.2600 Not a dermal sensitizer 47927818,

47927830 Acceptable

90-day Oral Toxicity-Rat

OCSPP 870.3100 NOEL= 1,000 ppm (56.6-58.7 mg/kg/day) 47927831 Acceptable

90-day Inhalation Toxicity

OCSPP 870.3465 Waiver Request 4 8869007 Acceptable

90-day dermal toxicity

OCSPP 870.3250 Waiver Request 4 8869006 Acceptable

Prenatal Developmental Toxicity Study - Rat

OCSPP 870.3700 Maternal NOEL > 500 mg/kg/day Developmental NOEL > 500 mg/kg/day 47927832 Acceptable

Bacterial Reverse

Mutation Test

OCSPP 870.5100 There was no evidence of

induced mutant colonies over background 47927833 Acceptable

In Vitro Mammalian

Chromosome Aberration

Tests

OCSPP 870.5375 There was no evidence of

cells with chromosomal

abnormalities 47927834 Acceptable

Classification: Acceptable; no additional data are required.

TABLE 4. Non-Target Organis m Toxicity Requirements for prohydrojasmon propyl-3- oxo-2-pentylcyclo-pentylacetate (40 CFR § 158.2060)

Guideline #

Test Results/Toxicology Category MRID Study

Conclusion

850.1010 Acute Toxicity Test, Daphnids EC 50 = 9.54 mg/L.
Moderately toxic 47927838 Acceptable

850.1075 Acute Toxicity Freshwater Fish Cyprinus carpio 96 hr LC 50 = 3.3 mg/L. Moderately toxic 47927837 Acceptable

850.2100 Avian Acute Oral Toxicity Bobwhite ( Colinus virginianus ) LD 50 >2000 mg/kg
Practically non-toxic 47927835 Acceptable

850.2200 Avian Dietary Toxicity Japanese quail ( Colinus virginianus ) LC 50 >5000 ppm
Practically non-toxic 47927836 Acceptable

Honey bee Acute Oral Toxicity LC 50 > 100 ug ai/bee 47927838 Acceptable

850.4100 Seedling Emergence and Seedling ER 50 > 1,140 g ai/ha (> 456 g ai/A) 48869004 AcceptableActive Ingredient Page 19 of 19 Biopesticides Registration Action Document

Guideline #

Test Results/Toxicology Category MRID Study

Conclusion

Growth

850.3020 Acute Contact Honeybees LD 50 = 0.129 ug ai/bee (0.116 – 0.148 ug ai/bee) 48869002 Acceptable

Ecotoxicity Data for FAL 1800 4.25 % ai (PDJ)

850.4150 Terrestrial Plant Vegetative Vigor ER 50 > 1,140 g ai/ha (> 456 g ai/A) 48869005 Acceptable

VIII. Appendix B.

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

.

IX. Appendix C.

REFERENCES

1. Parker, R.D., R.D. Jones and H.P. Nelson., 1995. GENEEC: A Screening Model for Pesticide Environmental Exposure Assessment, in Proceedings of the International Exposure Symposium on Water Quality Modelin g; American Society of Agricultural Engineers, pp. 485-490; Orlando, Florida.

2. U.S. EPA. 1998. Guidance for Ecological Risk Assessment. Risk Assessment Forum. EPA/630/R-95/002F, April 1998.

3. U.S.EPA 2008. Terrestrial Residue E xposure Model (T-REX) Version 1.4.1.

EFED/OPP/USEPA.

4. U.S.EPA 2004. Individual Effects Chan ce Model Version 1. 1. EFED/OPP/USEPA.

5. U.S. EPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs. Office of Prevention, Pe sticides, and Toxic S ubstances. Office of Pesticide Programs. Washington, D.C. January 23, 2004.